,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32343308,"Dexmedetomidine with sufentanil in intravenous patient-controlled analgesia for relief from postoperative pain, inflammation and delirium after esophageal cancer surgery.","BACKGROUND AND AIMS


Postoperative pain can cause serious adverse reactions that severely affect postoperative outcome. The present study evaluated the effect of dexmedetomidine (DEX) added to sufentanil in intravenous patient-controlled analgesia (PCA) on the relief of pain and inflammatory responses during postoperative recovery of patients undergoing a combined thoracoscopic-laparoscopic esophagectomy (TLE).
METHODS


Sixty patients undergoing TLE were randomly allocated to receive 1 μg/ml of sufentanil alone (Group S) or 1 μg/ml of sufentanil plus 2.5 μg/ml of DEX (Group D) for postoperative intravenous (IV) PCA. Postoperative pain relief, cumulative PCA requirements, inflammatory marker levels, delirium and recovery were assessed.
RESULTS


A joint DEX and sufentanil regimen significantly reduced the area under the curve of numerical rating scores for pain at rest (NRSR) and coughing (NRSC) at 1-48 h postoperatively (P = 0.000) that were associated with lower PCA-delivered cumulative sufentanil consumption and less PCA frequency until 48 h postoperatively (P < 0.05 and P < 0.0001, respectively). The simultaneous administration of DEX and sufentanil significantly reduced plasma IL-6 and TNF-α concentrations and increased IL-10 level (P < 0.0001, P = 0.0003 and P = 0.0345, respectively), accompanied by better postoperative delirium categories and health statuses of patients (P = 0.024 and P < 0.05, respectively). There was no hypotension, bradycardia, respiratory depression or oversedation in Group D.
CONCLUSION


Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses and lower postoperative delirium categories and better health statuses.",2020,"Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses.","['patients undergoing a', 'after Esophageal Cancer Surgery', 'Sixty patients undergoing TLE']","['Dexmedetomidine with Sufentanil', 'postoperative intravenous (IV) PCA', 'sufentanil alone (Group S) or 1 μg/ml of sufentanil plus 2.5 μg', 'DEX', 'dexmedetomidine (DEX', 'sufentanil', 'DEX and sufentanil', 'combined thoracoscopic-laparoscopic esophagectomy (TLE', 'IV PCA sufentanil', 'intravenous patient-controlled analgesia (PCA']","['cumulative sufentanil consumption and less PCA frequency', 'Postoperative Pain, Inflammation, and Delirium', 'postoperative delirium categories and health statuses', 'hypotension, bradycardia, respiratory depression, or oversedation', 'area under the curve of numerical rating scores for pain at rest (NRSR) and coughing (NRSC', 'Postoperative pain relief, cumulative PCA requirements, inflammatory marker levels, delirium, and recovery', 'postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses', 'plasma IL-6 and TNF-α concentrations and increased IL-10 level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0542127', 'cui_str': 'Oversedation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",60.0,0.453352,"Patients receiving DEX in addition to IV PCA sufentanil for TLE exhibited better postoperative analgesia, fewer inflammatory responses, and lower postoperative delirium categories and better health statuses.","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Zhetao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Zeyuan', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui 230001, China.'}]",Bioscience reports,['10.1042/BSR20193410']
1,32275872,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30150-X.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30150-X'],[],[],[],[],,0.019819,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30291-7']
2,32346981,Predicting bone and soft tissue alterations of immediate implant sites in the esthetic zone using clinical parameters.,"BACKGROUND


Immediate implantation is generally a predictable treatment, but sometimes there are significant tissue alterations at the surgical site which compromise clinical outcomes.
PURPOSE


This study aimed to investigate the association between tissue alterations and different clinical parameters in esthetic areas following immediate implant placement and provisionalization.
MATERIALS AND METHODS


Clinical parameters were measured at 36 non-grafted immediate implant sites enrolled in a randomized controlled trial. Alterations of bone and soft tissue were measured at 12 months after the treatment. Stepwise linear regression analysis was performed to analyze the association between different clinical parameters and outcomes of interest.
RESULTS


Gingival thickness 3 mm apical to the gingival margin (GT3) was positively associated with recession of mid-buccal gingival margin, while vertical distance between the buccal gingival margin and the crest (GM-bone) was negatively associated (P = .03, .01). Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01). Horizontal defect dimension was positively associated with buccal ridge dimensional reduction while gingival thickness at free gingival margin (GT1) was negatively associated (P = .01, .04). Regarding interproximal bone level change, none of the clinical parameters was significantly associated.
CONCLUSIONS


Gingival phenotype was the only parameter significantly associated with both buccal gingival recession and buccal ridge dimensional reduction. It is important to assess clinical parameters before and during immediate implant procedure.",2020,"Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01).",['Clinical parameters were measured at 36 non-grafted immediate implant sites enrolled in a randomized controlled trial'],['immediate implant placement and provisionalization'],"['Gingival thickness 3\u2009mm apical to the gingival margin (GT3', 'buccal gingival recession and buccal ridge dimensional reduction', 'Gingival phenotype', 'Flap elevation and older age', 'Alterations of bone and soft tissue', 'buccal ridge dimensional reduction while gingival thickness at free gingival margin (GT1']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",36.0,0.0323287,"Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01).","[{'ForeName': 'Chun-Teh', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontics and Dental Hygiene, The University of Texas Health Science Center School of Dentistry, Houston, Texas, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sanz-Miralles', 'Affiliation': 'Division of Periodontics, Section of Oral and Diagnostic Sciences, Columbia University College of Dental Medicine, New York, New York, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Biostatistics & Epidemiology Research Design Core, Center for Clinical and Translational Sciences, Department of Internal Medicine, Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Glick', 'Affiliation': 'Private practice, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': ""Department of Pediatric and Special Needs Dentistry, Arkansas Children's Hospital, Little Rock, Arkansas, USA.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Stoupel', 'Affiliation': 'Private practice, New York, New York, USA.'}]",Clinical implant dentistry and related research,['10.1111/cid.12910']
3,32340906,Assessment of conduction anesthesia effectiveness using the angulated needle approach for the inferior alveolar nerve block.,"BACKGROUND


Ambulatory painless surgery is dependent on local anesthesia effectiveness.
AIM


Evaluating the anesthetic efficacy of the angulated needle approach (ANA) for the inferior alveolar nerve block (IANB).
MATERIAL AND METHOD


Group I received direct IANB; group II received indirect IANB; group III received the IANB with ANA. The quality of anesthesia score (QAS), numerical pain intensity score (NRS), onset time of full anesthesia (OT), and perianesthetic complications were measured.
RESULTS


Ninety patients (mean age: 37.47 ± 18.90, p = 0.027) of both sexes were split into three equal groups. Group III had the lowest QAS value with the success rate of 93.3%, compared to the statistically significantly worse QAS values of group II, with the success rate of 80% (p = 0.016). Group II had the statistically significant highest NRS values relative to group I (p = 0.002) and group III (p = 0.000001). The shortest OT occurred in group I, when compared to group II (p = 0.000484) and group III (p = 0.000498). The transient syncope and positive aspiration occurred in single cases.
CONCLUSION


The ANA for the IANB could successfully serve as a ""first choice"", or as an ""addendum technique"" in the cases of multiple failed attempts for direct and indirect IANB techniques.",2020,"Group III had the lowest QAS value with the success rate of 93.3%, compared to the statistically significantly worse QAS values of group II, with the success rate of 80% (p = 0.016).","['Ninety patients (mean age: 37.47\xa0±\xa018.90, p\xa0=\xa00.027) of both sexes']","['IANB with ANA', 'angulated needle approach (ANA', 'indirect IANB', 'direct IANB']","['conduction anesthesia effectiveness', 'anesthetic efficacy', 'quality of anesthesia score (QAS), numerical pain intensity score (NRS), onset time of full anesthesia (OT), and perianesthetic complications', 'QAS values', 'transient syncope and positive aspiration', 'NRS values', 'shortest OT', 'success rate']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",90.0,0.0221863,"Group III had the lowest QAS value with the success rate of 93.3%, compared to the statistically significantly worse QAS values of group II, with the success rate of 80% (p = 0.016).","[{'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Tijanić', 'Affiliation': 'University of Niš, School of Medicine and Stomatology, Department of Oral Surgery, Niš, Serbia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Burić', 'Affiliation': 'Intern, Clinic of Stomatology, Niš, Serbia.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Stojanović', 'Affiliation': 'University of Niš, School of Medicine and Stomatology, Department of Oral Surgery, Niš, Serbia.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Burić', 'Affiliation': 'University of Niš, School of Medicine and Stomatology, Department of Oral Surgery, Niš, Serbia. Electronic address: nburic@yahoo.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.03.010']
4,32347216,Grinding the intaglio surface of yttria partially- and fully-stabilized zirconia polycrystals restorations: Effect on their fatigue behavior.,"This study evaluated the effects of diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ) adhesively cemented to dentin analogue substrate on the fatigue failure load, cycle number until failure, surface micromorphology and phase transformation. Disc-shaped specimens were produced from second (Katana ML-HT, Kuraray) and third-generation zirconia (Katana STML, Kuraray) and randomly allocated (n = 15) into two groups according to the intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface). The ceramic discs were adhesively cemented (Multilink Automix System) onto dentin analogue discs. Fatigue tests were executed by the step-stress method. The obtained data were analyzed by Kaplan Meier and Mantel-Cox tests. In addition, surface topography, roughness, phase transformation and fractography analyses were performed. SEM analysis showed that grinding increased the surface roughness and introduced defects in zirconia from both generations. Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 N < grinding: 1600 N), while these same outcomes were reduced by grinding for the third-generation zirconia significantly (control: 766.67 N > grinding: 620 N). Thus, clinical adjustments with diamond burs damage the fatigue behavior of adhesively cemented third-generation zirconia.",2020,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ",[],"['intaglio surface treatment: Control - Ctrl (without grinding); Grinding - Gr (grinding at the center of the intaglio surface', 'diamond bur grinding the intaglio surface of second (yttria partially-stabilized zirconia polycrystals, PSZ) and third-generation zirconia (fully-stabilized zirconia polycrystals, FSZ']","['surface roughness and introduced defects in zirconia', 'Fatigue tests', 'fatigue failure load, number of cycles to failure and survival rates', 'fatigue behavior']",[],"[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0292957', 'cui_str': 'yttria'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0215012,"Grinding increased the fatigue failure load, number of cycles to failure and survival rates of the second-generation zirconia statistically (control: 1373.33 ","[{'ForeName': 'Camila Pauleski', 'Initials': 'CP', 'LastName': 'Zucuni', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: camila-svs@hotmail.com.'}, {'ForeName': 'Bruna Dias', 'Initials': 'BD', 'LastName': 'Ilha', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: brunailha2@hotmail.com.'}, {'ForeName': 'Michele Mirian', 'Initials': 'MM', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: mmayodontologia@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Faculty of Odontology, Federal University of Santa Maria, Santa Maria, State of Rio Grande do Sul, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103800']
5,32342253,The association of primary tumor site with acute adverse event and efficacy of definitive chemoradiotherapy for cStage II/III esophageal cancer: an exploratory analysis of JCOG0909.,"BACKGROUND


JCOG0909 is a phase II trial of definitive chemoradiotherapy including salvage treatment for cStage II-III thoracic esophageal cancer; the radiation field for elective regional lymph node irradiation, which can affect patient outcome and adverse event, varied based on the primary tumor site, i.e., upper (Ut), middle (Mt), and lower thoracic (Lt) esophagus. The impact of different primary sites on the safety and efficacy of definitive chemoradiotherapy in JCOG0909 is not well characterized.
METHODS


Patients were categorized into three groups (Ut, Mt, and Lt) according to the primary tumor location. We compared acute adverse events during definitive chemoradiotherapy, complete response (CR) rate, 3-year progression-free survival (PFS), and overall survival (OS) among the 3 groups.
RESULTS


Out of the 96 patients enrolled in JCOG0909 between April 2010 and August 2014, 94 patients (16, 59, and 19 patients in the Ut, Mt, and Lt groups, respectively) were included in this exploratory analysis. The proportion of patients with cStage III was 25% in the Ut, 37% in the Mt, and 47% in the Lt group. Grade 3-4 leukopenia, neutropenia, and thrombocytopenia were more frequently observed in the Mt (66%, 54%, and 15%) and Lt groups (84%, 68%, and 16%) than in the Ut group (38%, 44%, and 0%). There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%).
CONCLUSIONS


In JCOG0909, the incidence of severe hematological toxicity had a trend toward higher in the Mt and Lt than the Ut esophageal cancer; however, no remarkable difference by primary sites was observed with respect to efficacy endpoints.",2020,"There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%).
","['Patients were categorized into three groups (Ut, Mt, and Lt) according to the primary tumor location', 'cStage II/III esophageal cancer', '94 patients (16, 59, and 19 patients in the Ut, Mt, and Lt groups, respectively) were included in this exploratory analysis', '96 patients enrolled in JCOG0909 between April 2010 and August 2014', 'cStage II-III thoracic esophageal cancer']",['definitive chemoradiotherapy'],"['3-year PFS', '3-year OS', 'CR rate', 'safety and efficacy', 'complete response (CR) rate, 3-year progression-free survival (PFS), and overall survival (OS', 'severe hematological toxicity', 'Grade 3-4 leukopenia, neutropenia, and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",96.0,0.0400083,"There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%).
","[{'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, 1-1 Idaigaoka Hasama-machi Yufu, Oita, 879-5593, Japan. shironaka@oita-u.ac.jp.'}, {'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Komori', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, 1-1 Idaigaoka Hasama-machi Yufu, Oita, 879-5593, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Onozawa', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Minashi', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Nozaki', 'Affiliation': 'Department of Surgery, Shikoku Cancer Center Hospital, Matsuyama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ura', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",Esophagus : official journal of the Japan Esophageal Society,['10.1007/s10388-020-00741-w']
6,32347899,Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial.,"Importance


Evidence-based treatments from randomized clinical trials for pedophilic disorder are lacking.
Objective


To determine whether a gonadotropin-releasing hormone antagonist reduces dynamic risk factors for committing child sexual abuse.
Design, Setting, and Participants


This academically initiated, double-blind, placebo-controlled, parallel-group, phase 2 randomized clinical trial was conducted at the ANOVA center in Stockholm, Sweden, from March 1, 2016, to April 30, 2019. Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited. Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention. The primary end point was assessed by intent-to-treat analysis.
Interventions


Randomization to receive either 2 subcutaneous injections of 120 mg of degarelix acetate or equal volume of placebo.
Main Outcomes and Measures


The primary end point was the mean change between baseline and 2 weeks in the composite risk score of 5 domains of child sexual abuse ranging from 0 to 15 points; each domain could be rated from 0 to 3 points. Secondary end points included efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events.
Results


A total of 52 male participants (mean [SD] age, 36 [12] years) were randomized to receive either degarelix (n = 25; with 1 withdrawal) or placebo (n = 26). At 2 weeks, the composite risk score decreased from 7.4 to 4.4 for participants in the degarelix group and from 7.8 to 6.6 for the placebo group, a mean between-group difference of -1.8 (95% CI, -3.2 to -0.5; P = .01). A decrease was seen in the composite score at 10 weeks (-2.2 [95% CI, -3.6 to -0.7]) as well as in the domains of pedophilic disorder (2 weeks: -0.7 [95% CI, -1.4 to 0.0]; 10 weeks: -1.1 [95% CI, -1.8 to -0.4]) and sexual preoccupation (2 weeks: -0.7 [95% CI, -1.2 to -0.3]; 10 weeks: -0.8 [95% CI, -1.3 to -0.3]) in the degarelix group compared with the placebo group. No difference was seen for the domains of self-rated risk (2 weeks: -0.4 [95% CI, -0.9 to 0.1]; 10 weeks: -0.5 [95% CI, -1 to 0.0]), low empathy (2 weeks: 0.2 [95% CI, -0.3 to 0.6]; 10 weeks: 0.2 [95% CI, -0.2 to 0.6]), and impaired self-regulation (2 weeks: -0.0 [95% CI, -0.7 to 0.6]; 10 weeks: 0.1 [95% CI, -0.5 to 0.8]), or quality of life (EuroQol 5 Dimensions questionnaire index score, 2 weeks: 0.06 [95% CI, -0.00 to 0.12], and 10 weeks: 0.04; 95% CI, -0.02 to 0.10; EuroQol visual analog scale, 2 weeks: 0.6 [95% CI, -9.7 to 10.9], and 10 weeks: 4.2 [95% CI, -6.0 to 14.4]). Two hospitalizations occurred from increased suicidal ideation, and more injection site reactions (degarelix: 22 of 25 [88%]; placebo: 1 of 26 [4%]) and hepatobiliary enzyme level elevations were reported by participants who received degarelix (degarelix: 11 of 25 [44%]; placebo: 2 of 26 [8%]). Among the 26 participants randomized to receive degarelix, 20 (77%) experienced positive effects (eg, improved attitude or behavior) on sexuality and 23 (89%) reported adverse effects on the body.
Conclusion and Relevance


This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option. Further studies are warranted into the effects and long-term adverse effects of hormone deficiency.
Trial Registration


EU Clinical Trials Register Identifier: 2014-000647-32.",2020,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","['committing child sexual abuse', 'Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention', 'Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited', 'Men With Pedophilic Disorder', '52 male participants (mean [SD] age, 36 [12] years']","['Gonadotropin-Releasing Hormone Antagonist', 'degarelix acetate or equal volume of placebo', 'gonadotropin-releasing hormone antagonist', 'degarelix (degarelix', 'degarelix', 'placebo']","['sexual preoccupation', 'intent-to-treat analysis', 'low empathy', 'efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events', 'composite risk score of 5 domains of child sexual abuse', 'Risk of Committing Child Sexual Abuse', 'composite risk score', 'suicidal ideation', 'hepatobiliary enzyme level elevations', 'composite score', 'impaired self-regulation', 'positive effects (eg, improved attitude or behavior) on sexuality', 'adverse effects', 'EuroQol visual analog scale', 'quality of life (EuroQol 5 Dimensions questionnaire index score', 'injection site reactions']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C2718533', 'cui_str': 'degarelix acetate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}]","[{'cui': 'C0423988', 'cui_str': 'Sexual preoccupation'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",52.0,0.615958,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","[{'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Landgren', 'Affiliation': 'Institute of Neuroscience and Physiology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Kinda', 'Initials': 'K', 'LastName': 'Malki', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Rahm', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0440']
7,32347785,"Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6-35 months in China.","Mismatch between circulating influenza B viruses and vaccine strains occurs frequently. In a randomized, double-blind, controlled phase III clinical study, healthy children aged 6-35 months were randomized into three groups at a ratio of 2:1:1, received two doses of quadrivalent influenza vaccines (QIVs) or licensed trivalent influenza vaccines (TIVs). The primary objective was to evaluate the non-inferiority immunogenicity of QIV compared with the two TIVs, containing B/Victoria or B/Yamagata strain. Safety information was collected for 28 days after each vaccination. Serious adverse events (SAEs) were monitored for 6 months after the second vaccination. A total of 2146 subjects (QIV: 1069, TIV-Vic: 540, TIV-Yam: 537) were enrolled in this study. QIV was found non-inferior to TIVs for shared strains (A/H1N1 and A/H3N2) and corresponding BY strain based on hemagglutination inhibition (HI) antibodies 28 days after the second dose of vaccination. The resulted geometric mean titer (GMT) ratios (QIV/TIV) were 0.98 (0.89, 1.07) for H1N1, 0.95 (0.85, 1.05) for H3N2 and 0.89 (0.81, 0.98) for BY. And the seroconversion rate differences (QIV-TIV) were -0.46% (-3.24%, 2.31%) for H1N1, -1.95% (-5.54%, 1.65%) for H3N2 and -3.58% (-8.11%, 0.95%) for BY. The BV strain in QIV did not reach the non-inferiority criteria, with GMT of 1:52.25 (vs. 1:61.02 of TIV-Vic) and seroconversion rate of 59.49% (vs. 66.85% of TIV-Vic). No increased safety concerns occurred in QIV group. Candidate QIV can provide good protection for children aged 6 to 35 months, and its immunogenicity and safety were proved.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov number: NCT03859141.",2020,QIV was found non-inferior to TIVs for shared strains (A/H1N1 and A/H3N2) and corresponding BY strain based on hemagglutination inhibition (HI) antibodies 28 days after the second dose of vaccination.,"['healthy children aged 6-35 months', 'children aged 6-35 months in China', '2146 subjects (QIV: 1069, TIV-Vic: 540']","['quadrivalent influenza vaccines (QIVs) or licensed trivalent influenza vaccines (TIVs', 'inactivated quadrivalent influenza vaccine']","['seroconversion rate', 'Safety information', 'non-inferiority immunogenicity of QIV', 'geometric mean titer (GMT) ratios (QIV/TIV', 'Serious adverse events (SAEs', 'safety concerns', 'seroconversion rate differences (QIV-TIV', 'Immunogenicity and safety', 'QIV']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0574482', 'cui_str': 'Tiv language'}, {'cui': 'C5192767', 'cui_str': '540'}]","[{'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0574482', 'cui_str': 'Tiv language'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2146.0,0.373521,QIV was found non-inferior to TIVs for shared strains (A/H1N1 and A/H3N2) and corresponding BY strain based on hemagglutination inhibition (HI) antibodies 28 days after the second dose of vaccination.,"[{'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Clinical Trials Assessment Department, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institutes for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Clinical Research Department, Sinovac Biotech Co., LTD ., Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': 'Clinical Trials Assessment Department, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, China.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Jia', 'Affiliation': 'Clinical Research Department, Sinovac Biotech Co., LTD ., Beijing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Clinical Trials Assessment Department, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Quality Assurance Department, Sinovac Biotech Co., LTD ., Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Quality Assurance Department, Sinovac Biotech Co., LTD ., Beijing, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institutes for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Clinical Trials Assessment Department, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1721994']
8,32344455,Pregnane X Receptor Activator Rifampin Increases Blood Pressure and Stimulates Plasma Renin Activity.,"We conducted a clinical trial with 22 healthy volunteers to investigate the effects of pregnane X receptor (PXR) agonist rifampin on blood pressure (BP). The study was randomized, crossover, single-blind, and placebo-controlled. Rifampin 600 mg or placebo once daily was administered for a week and the 24-hour ambulatory BP was monitored at the end of each arm on the eighth day. Rifampin elevated the mean systolic and diastolic 24-hour BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038). The serum renin concentration and the plasma renin activity were increased. Although rifampin increased circulating 4β-hydroxycholesterol (4βHC) as expected, the plasma 4βHC concentration strongly negatively correlated with 24-hour BP, especially systolic, in both rifampin and placebo arms (rifampin systolic BP, r = -0.69, P < 0.001; placebo systolic BP, r = -0.70, P < 0.001). The 4βHC, an agonist for liver X receptor (LXR), induced renin expression modestly in LXR-α expressing Calu-6 cells but only at unphysiologically high 4βHC concentrations. In conclusion, rifampin stimulates renin activity and has a hypertensive effect. This finding should be considered when designing interaction studies involving rifampin or other PXR agonists. Furthermore, PXR may represent a putative therapeutic target for the treatment of hypertension.",2020,"Rifampin elevated the mean systolic and diastolic 24hr BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038).",['22 healthy volunteers'],"['Pregnane X receptor activator rifampin', 'Rifampin 600 mg or placebo', 'pregnane X receptor (PXR) agonist rifampin', 'rifampin', 'placebo']","['mean systolic and diastolic 24hr BP', 'blood pressure and stimulates plasma renin activity', 'blood pressure (BP', 'plasma 4βHC concentration', 'serum renin concentration and the plasma renin activity', 'circulating 4β-hydroxycholesterol (4βHC', 'mean heart rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0671771', 'cui_str': 'SXR Receptor'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C1104996', 'cui_str': 'Rifampin 600 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",22.0,0.133873,"Rifampin elevated the mean systolic and diastolic 24hr BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hassani-Nezhad-Gashti', 'Affiliation': 'Research Unit of Biomedicine, Pharmacology and Toxicology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Tuire', 'Initials': 'T', 'LastName': 'Salonurmi', 'Affiliation': 'Biocenter Oulu, Oulu, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hautajärvi', 'Affiliation': 'Admescope Ltd., Oulu, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Rysä', 'Affiliation': 'School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Hakkola', 'Affiliation': 'Research Unit of Biomedicine, Pharmacology and Toxicology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Hukkanen', 'Affiliation': 'Biocenter Oulu, Oulu, Finland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1871']
9,32349117,One-day tropisetron treatment improves cognitive deficits and P50 inhibition deficits in schizophrenia.,"The core features of schizophrenia (SCZ) include cognitive deficits and impaired sensory gating represented by P50 inhibition deficits, which appear to be related to the α7 nicotinic acetylcholine receptor (nAChR). An agonist of nAChR receptor may improve these defects. This study aimed to investigate how administering multiple doses of tropisetron, a partial agonist of nAChR, for 1 day would affect cognitive deficits and P50 inhibition deficits in SCZ patients. We randomized 40 SCZ non-smokers into a double-blind clinical trial with four groups: placebo, 5 mg/d, 10 mg/d, and 20 mg/d of oral tropisetron. Their P50 ratios were all more than 0.5 and they took risperidone at 3-6 mg/day for at least a month before participating in the experiment. We measured the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and P50 inhibition before and one day after treatment. After one day of treatment, the total RBANS scores of the 20 mg and 5 mg tropisetron groups, and the immediate memory of the 10 mg group were significantly higher than placebo group. The P50 ratio was smaller in the 5 mg and 10 mg groups than in the placebo group (both p < 0.05) after treatment. Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude. One day of treatment with tropisetron improved both cognitive and P50 inhibition deficits, suggesting that longer term treatment with α7 nAChR agonists for these deficits in SCZ may be promising.",2020,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","['schizophrenia', 'SCZ patients']","['tropisetron', 'risperidone', 'oral tropisetron', 'placebo']","['S1 latency', 'P50 ratio', 'total RBANS scores', 'cognitive and P50 inhibition deficits', 'immediate memory score', 'P50 ratios', 'Neuropsychological Status (RBANS) and P50 inhibition', 'cognitive deficits and P50 inhibition deficits', 'RBANS total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2959617', 'cui_str': 'Repeatable battery for the assessment of neuropsychological status score'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",40.0,0.0632082,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Gaoxia', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiesi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hanjing E', 'Initials': 'HE', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Xiang Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China. zhangxy@psych.ac.cn.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0685-0']
10,32346371,Corrigendum: A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol Design.,[This corrects the article DOI: 10.3389/fpsyt.2019.01023.].,2020,[This corrects the article DOI: 10.3389/fpsyt.2019.01023.].,['Patients With a First-Episode Psychosis and Psychological Trauma'],['EMDR Versus TAU'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C3203533', 'cui_str': 'Psychological trauma'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",[],,0.0169125,[This corrects the article DOI: 10.3389/fpsyt.2019.01023.].,"[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Valiente-Gómez', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Pujol', 'Affiliation': 'IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moreno-Alcázar', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Radua', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eila', 'Initials': 'E', 'LastName': 'Monteagudo-Gimeno', 'Affiliation': 'Department of Psychiatry and Forensic Medicine, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Gardoki-Souto', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Hogg', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Álvarez', 'Affiliation': 'Mental Health Department, Vic Hospital Consortium, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Safont', 'Affiliation': 'CIBERSAM, Madrid, Spain.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Lupo', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Pérez', 'Affiliation': 'IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.'}, {'ForeName': 'Benedikt L', 'Initials': 'BL', 'LastName': 'Amann', 'Affiliation': 'Centre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00283']
11,32345990,Effects of β 2 -receptor stimulation by indacaterol in chronic heart failure treated with selective or non-selective β-blockers: a randomized trial.,"Alveolar β 2 -receptor blockade worsens lung diffusion in heart failure (HF). This effect could be mitigated by stimulating alveolar β 2 -receptors. We investigated the safety and the effects of indacaterol on lung diffusion, lung mechanics, sleep respiratory behavior, cardiac rhythm, welfare, and exercise performance in HF patients treated with a selective (bisoprolol) or a non-selective (carvedilol) β-blocker. Study procedures were performed before and after indacaterol and placebo treatments according to a cross-over, randomized, double-blind protocol in forty-four patients (27 on bisoprolol and 17 on carvedilol). No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2  slope and lower maximal P ET CO 2  during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2  31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2  36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively). In carvedilol, indacaterol was associated with a higher peak heart rate (119 ± 34 vs. 113 ± 30 bpm, with indacaterol and placebo) and a lower prevalence of hypopnea during sleep (3.8 [0.0;6.3] vs. 5.8 [2.9;10.5] events/hour, with indacaterol and placebo). Inhaled indacaterol is well tolerated in HF patients, it does not influence lung diffusion, and, in bisoprolol, it increases ventilation response to exercise.",2020,"No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2  slope and lower maximal P ET CO 2  during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2  31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2  36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively).","['forty-four patients (27 on bisoprolol and 17 on', 'chronic heart failure treated with selective or non-selective β-blockers', 'heart failure (HF', 'HF patients treated with a', 'HF patients']","['carvedilol', 'Inhaled indacaterol', 'indacaterol', 'indacaterol and placebo', 'carvedilol, indacaterol', 'selective (bisoprolol) or a non-selective (carvedilol) β-blocker', 'placebo']","['peak heart rate', 'lung diffusion, lung mechanics, sleep respiratory behavior, cardiac rhythm, welfare, and exercise performance', 'hypopnea during sleep']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",,0.162873,"No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2  slope and lower maximal P ET CO 2  during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2  31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2  36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively).","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Contini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Spadafora', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Barbieri', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gugliandolo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Salvioni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Magini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Apostolo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Palermo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Alimento', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Piergiuseppe', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy. piergiuseppe.agostoni@ccfm.it.'}]",Scientific reports,['10.1038/s41598-020-62644-1']
12,32348714,Precision and Safety of an Intravascular Temperature Management System for Postcardiac Arrest Syndrome Patients: A Multicenter Clinical Trial (COOL-ARREST JP).,"Rapid induction and maintaining a target temperature of 32.0-36.0°C within a narrow range for <24 hours are essential, but those are very hard to perform in postcardiac arrest syndrome (PCAS) patients. We investigated the usability of an intravascular temperature management (IVTM) system with neurolept-anesthesia (NLA; droperidol and fentanyl). Single-arm, prospective multicenter trial was carried out in the seven university and the three affiliated hospitals. In the 24 comatose PCAS patients, the target temperature (33.0°C) was rapidly induced and maintained for 24 hours using an IVTM system with NLA. The rewarming speed was 0.1°C/h until 36.5°C and was maintained for 24 hours. The primary end point was the ability to achieve ≤34.0°C for <3 hours after starting cooling, and the secondary end points were the cooling rate, deviation from the target temperature, and adverse events. Cerebral Performance Category (CPC) score at 14 days was also evaluated. Statistical analyses were performed by SPSS software, using the intention-to-treat data sets. The target temperature of ≤34.0°C was reached by 45 minutes (35-73 minutes) and was within 3 hours in all patients. The cooling rate from 36.4°C to 33.0°C was 2.7°C/h (2.4-3.6°C/h). The temperature of 33.1°C (33.1-33.1°C) and 36.7°C (36.6-36.9°C) for 24 hours each was held during the maintenance and the after rewarming phases, respectively. Temperature deviations >0.2°C from 33.0°C in the maintenance phase occurred once each in two patients. The favorable neurological outcomes (CPC1, 2) were relatively good (50%). Five patients experienced serious adverse events; none was device related. We rapidly achieved therapeutic hypothermia within a narrow temperature range without major complications using the IVTM system with NLA in PCAS patients.",2020,We rapidly achieved therapeutic hypothermia within a narrow temperature range without major complications using the IVTM system with NLA in PCAS patients.,"['seven university and the three affiliated hospitals', '24 comatose PCAS patients', 'Postcardiac Arrest Syndrome Patients', 'PCAS patients']","['Intravascular Temperature Management System', 'intravascular temperature management (IVTM) system with neurolept-anesthesia (NLA; droperidol and fentanyl']","['cooling rate', 'ability to achieve ≤34.0°C', 'cooling rate, deviation from the target temperature, and adverse events', 'Cerebral Performance Category (CPC) score', 'rewarming speed', 'serious adverse events']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C4285706', 'cui_str': 'Post cardiac arrest syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",2.0,0.0424732,We rapidly achieved therapeutic hypothermia within a narrow temperature range without major complications using the IVTM system with NLA in PCAS patients.,"[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Maekawa', 'Affiliation': 'Yamaguchi Prefectural University, Yamaguchi, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Kaneda', 'Affiliation': 'Advanced Medical Emergency and Critical Care Medicine, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Tsuruta', 'Affiliation': 'Advanced Medical Emergency and Critical Care Medicine, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kuroda', 'Affiliation': 'Emergency Medical Center, Kagawa University Hospital, Miki, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'Cardiovascular Disease Center, Nihon University Hospital (Surugadai), Nihon University Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Rinka', 'Affiliation': 'Emergency and Critical Medical Care Center, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yokota', 'Affiliation': 'Emergency and Critical Care Medicine, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Shirai', 'Affiliation': 'Cardio-Vascular Center, Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Hase', 'Affiliation': 'Department of Traumatology and Critical Care Medicine, Sapporo Medical University Hospital, Sapporo, Japan.'}, {'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Kotani', 'Affiliation': 'Center for Emergency and Critical Care Medicine, Kobe University Hospital, Kobe University Hospital, Kobe, Japan.'}, {'ForeName': 'Shigeatsu', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Advanced Emergency and Critical Care Center, Iwate Medical University Hospital, Morioka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2019.0046']
13,32353573,Sick days in general hospital patients two years after brief alcohol intervention: Secondary outcomes from a randomized controlled trial.,"Little is known about the long-term impact of brief alcohol interventions (BAIs) on health and on sick days in particular. The aim was to investigate whether BAIs reduce sick days in general hospital patients over two years, and whether effects depend on how BAIs are delivered; either through in-person counseling (PE) or computer-generated written feedback (CO). To investigate this, secondary outcome data from a three-arm randomized controlled trial with 6-, 12-, 18- and 24-month follow-ups were used. The sample included 960 patients (18-64 years) with at-risk alcohol use identified through systematic screening on 13 hospital wards. Patients with particularly severe alcohol problems were excluded. Participants were allocated to PE, CO and assessment only (AO). Both interventions were tailored according to behavior change theory and included three contacts. Self-reported number of sick days in the past 6 months was assessed at all time-points. A zero-inflated negative binomial latent growth model adjusted for socio-demographics, substance use related variables and medical department was calculated. In comparison to AO, PE (OR = 2.18, p = 0.047) and CO (OR = 2.08, p = 0.047) resulted in statistically significant increased odds of reporting no sick days 24 months later. Differences between PE and CO, and concerning sick days when any reported, were non-significant. This study provides evidence for the long-term efficacy of BAIs concerning health, and concerning sick days in particular. BAIs have the potential to reduce the occurrence of sick days over 2 years, independent of whether they are delivered through in-person counseling or computer-generated written feedback.",2020,"In comparison to AO, PE (OR = 2.18, p = 0.047) and CO (OR = 2.08, p = 0.047) resulted in statistically significant increased odds of reporting no sick days 24 months later.","['960 patients (18-64\u202fyears) with at-risk alcohol use identified through systematic screening on 13 hospital wards', 'general hospital patients two years after brief', 'Patients with particularly severe alcohol problems', 'general hospital patients over two years']","['BAIs', 'alcohol interventions (BAIs', 'person counseling (PE) or computer-generated written feedback (CO', 'alcohol intervention']",['CO'],"[{'cui': 'C4517908', 'cui_str': '960'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",960.0,0.0902359,"In comparison to AO, PE (OR = 2.18, p = 0.047) and CO (OR = 2.08, p = 0.047) resulted in statistically significant increased odds of reporting no sick days 24 months later.","[{'ForeName': 'Jennis', 'Initials': 'J', 'LastName': 'Freyer-Adam', 'Affiliation': 'Institute for Medical Psychology, University Medicine Greifswald, Greifswald, Germany; German Center for Cardiovascular Research, Site Greifswald, Greifswald, Germany. Electronic address: Jennis.Freyer-Adam@med.uni-greifswald.de.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Baumann', 'Affiliation': 'German Center for Cardiovascular Research, Site Greifswald, Greifswald, Germany; Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany; Institute and Policlinic of Occupational and Social Medicine, Faculty of Medicine, Technische Universität Dresden, Germany.'}, {'ForeName': 'Gallus', 'Initials': 'G', 'LastName': 'Bischof', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'John', 'Affiliation': 'German Center for Cardiovascular Research, Site Greifswald, Greifswald, Germany; Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Gaertner', 'Affiliation': 'Department of Epidemiology and Health Monitoring, Robert Koch Institute Berlin, Berlin, Germany.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106106']
14,32351061,[Systemic enzyme therapy for treatment of women with chronic recurrent bacterial cystitis].,"INTRODUCTION


In most cases, treatment of infectious and inflammatory diseases, including lower urinary tract infections, includes antibacterial drugs. However, their efficiency decreases every year. The absence of new groups of antibiotics makes it necessary to develop alternative treatment schemes and methods for improving efficiency of existing drugs. Systemic enzyme therapy is one of the promising directions in the treatment of lower urinary tract infections, which was shown to be effective for treating a number of diseases.
AIM


to evaluate the results of complex treatment of women with chronic recurrent bacterial cystitis using a drug for systemic enzyme therapy.
MATERIALS AND METHODS


The examination and treatment of 60 women aged 19 to 45 years with an exacerbation of chronic recurrent bacterial cystitis, who were randomly divided into two groups of 30 patients, was performed. In the group 1, patients received standard antibiotic therapy. In the group 2, women additionally received Phlogenzym. An evaluation of the efficiency was carried out on the 1st, 7th and 14th day and included analysis of lower urinary tract symptoms, according to bladder diaries, assessment of pain intensity and laboratory tests (C-reactive protein [CRP], IL-6, IL-1, TNF. During long-term follow-up (6 months after completion of treatment), the relapse rate was evaluated in both groups.
RESULTS


At admission, all women had clinical and laboratory signs of cystitis. By the 14th day, there was normalization of evaluated parameters in both groups. However, in patients receiving systemic enzyme therapy a more rapid relief of the inflammatory process (a decrease in the frequency of urination, urgency, nocturia, severity of inflammatory changes in the blood and urine) by the 7th day of treatment was observed. During a further 6-month follow-up, relapses were detected in 9 (30%) and 4 (13.3%) patients in group 1 and 2, respectively.
CONCLUSION


The results of the study demonstrated the high efficiency of systemic enzyme therapy. Its use for complex treatment provides more rapid relief of lower urinary tract symptoms and pain, as well as reduces the number of relapses in women with chronic recurrent bacterial cystitis.",2020,"By the 14th day, there was normalization of evaluated parameters in both groups.","['60 women aged 19 to 45 years with an exacerbation of chronic recurrent bacterial cystitis', 'women with chronic recurrent bacterial cystitis using a drug for systemic enzyme therapy', 'women with chronic recurrent bacterial cystitis']","['systemic enzyme therapy', 'Systemic enzyme therapy', 'Phlogenzym', 'standard antibiotic therapy']","['frequency of urination, urgency, nocturia, severity of inflammatory changes in the blood and urine', 'clinical and laboratory signs of cystitis', 'rapid relief of the inflammatory process', 'bladder diaries, assessment of pain intensity and laboratory tests (C-reactive protein [CRP], IL-6, IL-1, TNF', 'relapse rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1959870', 'cui_str': 'Recurrent bacterial cystitis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2936197', 'cui_str': 'Enzymotherapy'}]","[{'cui': 'C2936197', 'cui_str': 'Enzymotherapy'}, {'cui': 'C0769132', 'cui_str': 'Phlogenzym'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",60.0,0.01888,"By the 14th day, there was normalization of evaluated parameters in both groups.","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': ""Kuz'menko"", 'Affiliation': 'Department of Urology of FGBOU VO Voronezh State Medical University named after N.N. Burdenko, Voronezh, Russia.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': ""Kuz'menko"", 'Affiliation': 'Department of Urology of FGBOU VO Voronezh State Medical University named after N.N. Burdenko, Voronezh, Russia.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Gyaurgiev', 'Affiliation': 'Department of Urology of FGBOU VO Voronezh State Medical University named after N.N. Burdenko, Voronezh, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
15,32352644,Effects of Dapagliflozin on Epicardial Fat Thickness in Patients with Type 2 Diabetes and Obesity.,"OBJECTIVE


Epicardial adipose tissue (EAT) thickness is a marker of visceral fat and an emerging therapeutic target. Dapagliflozin, a selective sodium-glucose cotransporter 2 inhibitor, improves glucose control and induces moderate weight loss in patients with type 2 diabetes mellitus. Dapagliflozin has recently been shown to reduce cardiovascular risk. Nevertheless, whether dapagliflozin could reduce EAT thickness is unknown.
METHODS


This hypothesis was tested in a 24-week, randomized, double-blind, placebo-controlled clinical trial in 100 patients with type 2 diabetes mellitus with BMI ≥ 27 kg/m 2  and a hemoglobin A1c level ≤ 8% on metformin monotherapy. Individuals were randomly assigned to 2 groups to receive additional dapagliflozin up to 10 mg once daily or to remain on metformin up to 1,000 mg twice daily. Ultrasound-measured EAT thickness was measured at baseline, 12 weeks, and 24 weeks.
RESULTS


In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction. There was no statistically significant correlation between EAT and body weight changes.
CONCLUSIONS


Dapagliflozin causes a rapid and significant EAT reduction that could be independent of weight loss.",2020,"In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction.","['100 patients with type 2 diabetes mellitus with BMI\u2009≥\u200927 kg/m 2  and a hemoglobin A1c level\u2009≤\u20098% on', 'patients with type 2 diabetes mellitus', 'Patients with Type 2 Diabetes and Obesity']","['metformin monotherapy', 'dapagliflozin', 'metformin', 'additional dapagliflozin up to 10 mg once daily or to remain on metformin', 'Dapagliflozin', 'placebo']","['smaller EAT reduction', 'EAT', 'weight loss', 'moderate weight loss', 'EAT and body weight changes', 'Ultrasound-measured EAT thickness', 'EAT thickness', 'Epicardial Fat Thickness']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",100.0,0.062762,"In the dapagliflozin group, EAT decreased by 20% from baseline to 24 weeks, by 15% after 12 weeks, and by 7% between 12 and 24 weeks, respectively (P < 0.01 for all), whereas in the metformin group, there was a significant but smaller EAT reduction.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gra-Menendez', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22798']
16,32351205,"Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension.","STUDY OBJECTIVES


Esmirtazapine (1.5-4.5 mg) has demonstrated short-term sleep-promoting effects in nonelderly outpatients with chronic insomnia. This phase 3, randomized, double-blind study (NCT00631657) and its open-label extension (NCT00750919) investigated efficacy and safety of long-term esmirtazapine treatment in adult outpatients with chronic insomnia.
METHODS


Participants were randomized to receive esmirtazapine 4.5 mg or placebo for 6 months; those receiving esmirtazapine were then rerandomized to esmirtazapine or placebo for an additional 7 days. Participants could enter the 6-month open-label extension with esmirtazapine 4.5 mg. The primary objective of the double-blind study was to assess long-term efficacy of esmirtazapine vs placebo on self-reported total sleep time. Assessing long-term safety and tolerability were secondary and primary objectives of the double-blind and extension studies, respectively.
RESULTS


Overall, 457 participants received treatment in the double-blind study (esmirtazapine, n = 342; placebo, n = 115) and 184 participants (prior esmirtazapine, n = 136; prior placebo, n = 48) received esmirtazapine in the extension. In the double-blind study, a 48.7-minute increase in average nightly total sleep time was observed for esmirtazapine vs placebo (95% confidence interval, 35.0-62.5; P < .0001) at months 4-6. There was no evidence of residual effects on next-day alertness or daytime functioning and no evidence of rebound insomnia or withdrawal symptoms upon treatment discontinuation. Esmirtazapine was generally well tolerated; somnolence and weight gain were the most common adverse events.
CONCLUSIONS


Esmirtazapine improved sleep duration vs placebo over at least 6 months. There was no evidence of next-day residual effects or of withdrawal symptoms or rebound insomnia following abrupt treatment discontinuation.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002); URL: https://clinicaltrials.gov/ct2/show/NCT00631657; Identifier: NCT00631657; and Registry: ClinicalTrials.gov; Name: Twenty-Six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007); URL: https://clinicaltrials.gov/ct2/show/NCT00750919); Identifier: NCT00750919.",2020,"There was no evidence of next-day residual effects, or of withdrawal symptoms or rebound insomnia following abrupt treatment discontinuation.
","['non-elderly outpatients with chronic insomnia', 'adult outpatients with chronic insomnia', 'With Chronic Primary Insomnia (21106/P05701/MK-8265-002', '457 participants received treatment in the double-blind study (esmirtazapine, n=342; placebo, n=115) and 184 participants (prior esmirtazapine, n=136; prior', 'adult outpatients with chronic primary insomnia', 'Participants', 'Adult Patients', 'Outpatients With Chronic Primary Insomnia']","['Esmirtazapine', 'esmirtazapine', 'Org 50081 (Esmirtazapine', 'esmirtazapine or placebo', 'esmirtazapine versus placebo', 'esmirtazapine 4.5 mg or placebo', 'long-term esmirtazapine', 'placebo']","['sleep duration', 'self-reported total sleep time', 'withdrawal symptoms or rebound insomnia', 'average nightly total sleep time', 'Efficacy and safety', 'efficacy and safety', 'Assessing long-term safety and tolerability', 'rebound insomnia or withdrawal symptoms', 'tolerated; somnolence and weight gain', 'residual effects on next-day alertness or daytime functioning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C2700014', 'cui_str': '(S)-Mirtazapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2700014', 'cui_str': '(S)-Mirtazapine'}, {'cui': 'C4279659', 'cui_str': 'Org 50081'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0270541', 'cui_str': 'Rebound insomnia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",50081.0,0.628741,"There was no evidence of next-day residual effects, or of withdrawal symptoms or rebound insomnia following abrupt treatment discontinuation.
","[{'ForeName': 'Neely', 'Initials': 'N', 'LastName': 'Ivgy-May', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Goeran', 'Initials': 'G', 'LastName': 'Hajak', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Social Foundation Bamberg, Bamberg, Germany.'}, {'ForeName': 'Gonnie', 'Initials': 'G', 'LastName': 'van Osta', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'MSD, Oss, The Netherlands.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Chang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8526']
17,32350810,Correction to: Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.,In Methods section under Study Design and Patients.,2020,In Methods section under Study Design and Patients.,['Indian Men'],['Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions'],['Androgenetic Alopecia'],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]",,0.0800492,In Methods section under Study Design and Patients.,"[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Dermatology, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Vartak', 'Affiliation': 'C.L.A.I.M.S. Pvt Ltd, Mumbai, Maharashtra, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Nikhil Kumar', 'Initials': 'NK', 'LastName': 'Kursam', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Amey', 'Initials': 'A', 'LastName': 'Mane', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India.""}, {'ForeName': 'Sujeet Narayan', 'Initials': 'SN', 'LastName': 'Charugulla', 'Affiliation': ""Dr. Reddy's Laboratories Pvt Ltd, Ameerpet, Hyderabad, India. sujeetnc@drreddys.com.""}]",Dermatology and therapy,['10.1007/s13555-020-00381-z']
18,32350816,Correction to: Is Open-Label Placebo a New Ergogenic Aid? A Commentary on Existing Studies and Guidelines for Future Research.,"Page 4, Figure 1.",2020,"Page 4, Figure 1.",[],[],[],[],[],[],,0.0186372,"Page 4, Figure 1.","[{'ForeName': 'Tiemi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Barreto', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Rheumatology Division, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, Cerqueira César, São Paulo, SP, CEP: 01246903, Brazil. gualano@usp.br.'}]","Sports medicine (Auckland, N.Z.)",['10.1007/s40279-020-01289-6']
19,32356515,"Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy.","STUDY OBJECTIVES


To determine the time course and duration of common, early-onset treatment-emergent adverse events (TEAEs) associated with sodium oxybate (SXB) use in adults with narcolepsy.
METHODS


These were post hoc analyses of two 8-week, randomized, double-blind, placebo-controlled trials. In SXB-15, participants (n = 246) received daily placebo (n = 60) or SXB (n = 186) initiated at 4.5 g. Participants assigned to SXB 6 or 9 g were titrated in 1.5-g increments. In SXB-22, participants entering on modafinil (n = 231) received placebo (n = 56), SXB (n = 55), modafinil (n = 63), or SXB and modafinil (n = 57). SXB was initiated at 6 g for weeks 1-4 and increased to 9 g for weeks 5-8. TEAEs reported more frequently in SXB-treated participants than placebo and in ≥5% of any SXB treatment group during week 1 were examined as TEAEs of interest.
RESULTS


Dizziness and nausea met criteria as TEAEs of interest in both studies; headache also met criteria as a TEAE of interest in SXB-15. Incidence of new or worsened TEAEs was highest at week 1 (SXB-15: dizziness, 7.5%; headache, 7.5%; nausea, 5.9%; SXB-22: dizziness, 5.4%; nausea, 7.1%) and decreased over time in both studies. The longest median duration was reported for dizziness: 9.0 and 17.5 days in SXB-15 and SXB-22, respectively. Dizziness caused discontinuation in 2.2% and 3.6% of participants in SXB-15 and SXB-22, respectively; nausea caused discontinuation in 2.7% and 1.8%.
CONCLUSIONS


Common early-onset TEAEs associated with SXB treatment were generally of short duration and their incidence decreased over time. These TEAEs accounted for few discontinuations overall.
CLINICAL TRIALS REGISTRATION


Registry: ClinicalTrials.gov; Names: Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients; Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy; URLs: https://clinicaltrials.gov/ct2/show/NCT00049803 and https://clinicaltrials.gov/ct2/show/NCT00066170; Identifiers: NCT00049803 and NCT00066170.",2020,"TEAEs reported more frequently in SXB-treated participants than placebo and in ≥5% of any SXB treatment group during week 1 were examined as TEAEs of interest.
","['participants with narcolepsy', 'adults with narcolepsy']","['SXB', 'SXB and modafinil', 'placebo', 'daily placebo', 'sodium oxybate (SXB', 'modafinil', 'sodium oxybate']","['dizziness', 'Incidence and duration of common, early-onset adverse events', 'Dizziness caused discontinuation', 'Incidence of new or worsened TEAEs', 'longest median duration', 'nausea caused discontinuation']","[{'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037537', 'cui_str': 'Sodium Oxybate'}, {'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.180111,"TEAEs reported more frequently in SXB-treated participants than placebo and in ≥5% of any SXB treatment group during week 1 were examined as TEAEs of interest.
","[{'ForeName': 'Aatif M', 'Initials': 'AM', 'LastName': 'Husain', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Bujanover', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ryan', 'Affiliation': 'Jazz Pharmaceuticals, Philadelphia, Pennsylvania.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Scheckner', 'Affiliation': 'Jazz Pharmaceuticals, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Profant', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8530']
20,32356592,'It just wasn't going to be heard': A mixed methods study to compare different ways of involving people with diabetes and health-care professionals in health intervention research.,"BACKGROUND


Guidelines recommend involving intervention users in the intervention development process. However, there is limited guidance on how to involve users in a meaningful and effective way.
OBJECTIVE


The aim of this Study within a trial was to compare participants' experiences of taking part in one of three types of consensus meetings-people with diabetes-only, combined people with diabetes and health-care professionals (HCPs) or HCP-only meeting.
DESIGN


The study used a mixed methods convergent design. Quantitative (questionnaire) and qualitative (observation notes and semi-structured telephone interviews) data were collected to explore participants' experiences. A triangulation protocol was used to compare quantitative and qualitative findings.
PARTICIPANTS


People with diabetes (recruited via multiple strategies) were randomly assigned to attend the people with diabetes or combined meeting. HCPs (recruited through professional networks) attended the HCP or combined meeting based on their availability.
RESULTS


Sixteen people with diabetes and 15 HCPs attended meetings, of whom 18 participated in a telephone interview. Participants' questionnaire responses suggested similar positive experiences across the three meetings. Observation and semi-structured interviews highlighted differences experienced by participants in the combined meeting relating to: perceived lack of common ground; feeling empowered versus undervalued; needing to feel safe and going off task to fill the void.
CONCLUSIONS


The qualitative theme 'needing to feel safe' may explain the dissonance (disagreement) between quantitative and qualitative data. In this study, involving patients and HCPs simultaneously in a consensus process was not found to be as suitable as involving each stakeholder group separately.",2020,"Observation and semi-structured interviews highlighted differences experienced by participants in the combined meeting relating to: perceived lack of common ground; feeling empowered versus undervalued; needing to feel safe and going off task to fill the void.
","['People with diabetes (recruited via multiple strategies', ""participants' experiences of taking part in one of three types of consensus meetings-people with diabetes-only, combined people with diabetes and health-care professionals (HCPs) or HCP-only meeting"", 'Sixteen people with diabetes and 15 HCPs attended meetings, of whom 18 participated in a telephone interview', 'people with diabetes and health-care professionals in health intervention research']",[],['Quantitative (questionnaire) and qualitative (observation notes and semi-structured telephone interviews) data'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0162531', 'cui_str': 'Hereditary coproporphyria'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",[],"[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}]",16.0,0.0926695,"Observation and semi-structured interviews highlighted differences experienced by participants in the combined meeting relating to: perceived lack of common ground; feeling empowered versus undervalued; needing to feel safe and going off task to fill the void.
","[{'ForeName': 'Emmy', 'Initials': 'E', 'LastName': 'Racine', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Riordan', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Phillip', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'Flynn', 'Affiliation': 'Independent Patient and Public Involvement Partner, Co. Clare, Ireland.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McHugh', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.13061']
21,32356413,Twelve-hour fasting compared with expedited oral intake in the initial inpatient management of hyperemesis gravidarum: a randomised trial.,"OBJECTIVE


To evaluate fasting for 12 hours compared with expedited oral feeding in hospitalised women with hyperemesis gravidarum (HG).
DESIGN


Randomised trial.
SETTING


University Hospital, Malaysia: April 2016-April 2017.
POPULATION


One hundred and sixty women hospitalised for HG.
METHOD


Women were randomised upon admission to fasting for 12 hours or expedited oral feeding. Standard HG care was instituted.
MAIN OUTCOME MEASURE


Primary outcome was satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score at enrolment, and at 8, 16 and 24 hours.
RESULTS


Satisfaction score, median (interquartile range) 8 (5-9) versus 8 (7-9) (P = 0.08) and 24-hour vomiting episodes were 1 (0-4) versus 1 (0-5) (P = 0.24) for 12-hour fasting versus expedited feeding, respectively. Repeated measures analysis of variance of nausea scores over 24 hours showed no difference (P = 0.11) between trial arms. Participants randomised to 12-hour fasting compared with expedited feeding were less likely to prefer their feeding regimen in future hospitalisation (41% versus 65%, P = 0.001), to recommend to a friend (65% versus 84%, P = 0.01; RR 0.8, 95% CI 0.6-0.9) and to adhere to protocol (85% versus 95%, P = 0.04; RR 0.9, 95% CI 0.8-1.0). Symptoms profile, ketonuria status at 24 hours and length of hospital stay were not different.
CONCLUSION


Advisory of 12-hour fasting compared with immediate oral feeding resulted in a non-significant difference in satisfaction score but adherence to protocol and fidelity to and recommendation of immediate oral feeding to a friend were lower. The 24-hour nausea scores and vomiting episodes were similar.
TWEETABLE ABSTRACT


Women hospitalised for hyperemesis gravidarum could feed as soon, as much and as often as can be tolerated compared with initial fasting.",2020,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","['hospitalised hyperemesis gravidarum (HG) DESIGN', '160 women hospitalised for hyperemesis gravidarum (HG) METHOD', 'University Hospital, Malaysia: April 2016-April']",[],"['24-hour vomiting episodes', 'nausea scores', 'satisfaction score', '24-hour nausea scores and vomiting episodes', 'satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score', 'Symptoms profile, ketonuria status at 24 hours and length of hospital stay']","[{'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162275', 'cui_str': 'Ketonuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.218001,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","[{'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Abdussyukur', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Win', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16290']
22,32358661,Comparison of the short-term results of single-dose intra-articular peptide with hyaluronic acid and platelet-rich plasma injections in knee osteoarthritis: a randomized study.,"INTRODUCTION/OBJECTIVES


Intra-articular injections may be useful in terms of pain and functional status, in knee osteoarthritis (OA). Besides hyaluronic acid (HA) and platelet-rich plasma (PRP), peptide molecules recently begin to be used. The aim of this study was to compare the efficacy of intra-articular peptide Prostrolane® (CAREGEN Co. Ltd.) injection with that of the HA and PRP in the persons with OA.
METHOD


Fifty-four patients with OA were included in this prospective, randomized study. Patients were randomized into three groups as intra-articular HA, peptide, and PRP groups. Paracetamol was permitted three times a day to all groups. All the patients were evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), and visual analogue scale (VAS) at rest and during movements. Measurements performed at the baseline, after the first week of injection, and at the first and third months of follow-up.
RESULTS


Mean age was 55.8 ± 8.9 years. Forty-four (81.6%) were women. A week after the injections, rest and movement pain severity was measured by VAS decreased significantly in all the study groups (p < 0.05). There were no statistically significant differences between the groups in terms of first week pain relief (p > 0.05). WOMAC pain, stiffness, function, and total scores were improved significantly in all the groups a week after the injections (p < 0.05). Improvement continued at the third month control; however, the improvement in the WOMAC pain score was significantly better in the peptide group at the third month control (p < 0.05). The decrease in the rest and movement pain was continued for 3 months except the HA group's rest pain. There were no differences among the groups for all measurements, except for the WOMAC pain score at 3 months after treatment, which was significantly lower in the peptide group.
CONCLUSION


As a result, pain relief and functional improvement were obtained after the intra-articular HA, peptide, and PRP injections in OA, and decrease in pain was better in the peptide group. Key Points • The short-term effects of intra-articular HA, peptide, and PRP injections were compared in knee osteoarthritis. • HA, peptide, and PRP injections may be useful in pain relief and functional improvement in knee osteoarthritis.",2020,"There were no differences among the groups for all measurements, except for the WOMAC pain score at 3 months after treatment, which was significantly lower in the peptide group.
","['persons with OA', 'Fifty-four patients with OA', 'Mean age was 55.8\u2009±\u20098.9\xa0years', 'knee osteoarthritis', 'Forty-four (81.6%) were women']","['hyaluronic acid (HA', 'intra-articular HA, peptide, and PRP injections', 'Paracetamol', 'hyaluronic acid and platelet-rich plasma injections', 'intra-articular peptide Prostrolane®']","['rest and movement pain', 'pain relief', 'pain relief and functional improvement', 'VAS', 'rest and movement pain severity', 'WOMAC pain, stiffness, function, and total scores', 'pain', 'WOMAC pain score', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), and visual analogue scale (VAS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}]",54.0,0.0229307,"There were no differences among the groups for all measurements, except for the WOMAC pain score at 3 months after treatment, which was significantly lower in the peptide group.
","[{'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktas', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey. nur.kesiktas@gmail.com.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Dernek', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ekin Ilke', 'Initials': 'EI', 'LastName': 'Sen', 'Affiliation': 'Department of PMR, MD, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Havva Nur', 'Initials': 'HN', 'LastName': 'Albayrak', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Aydin', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Yildiz', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}]",Clinical rheumatology,['10.1007/s10067-020-05121-4']
23,32358477,"Impact of the Fascia Iliaca Block on Pain, Opioid Consumption, and Ambulation for Patients With Hip Fractures: A Prospective, Randomized Study.","OBJECTIVES


To determine the effect of the fascia iliaca block (FIB) on patients undergoing surgery for hip fractures.
DESIGN


Prospective, randomized controlled trial.
SETTING


Level I trauma center.
PATIENTS/PARTICIPANTS


Patients (N = 97) undergoing surgery for hip fractures were prospectively randomized to receive either a perioperative FIB (FIB group) or no block (control group) from February 2018 to April 2019.
MAIN OUTCOME MEASURES


Visual analog scale (VAS) score, morphine milligram equivalents, and postoperative ambulatory distance.
RESULTS


Fifty-seven patients were randomized to the FIB group, and 40 patients were randomized to the control group. Eighteen patients crossed over from the FIB to the control group, and 12 patients crossed over from the control to the FIB group. In the intent-to-treat analysis, demographic data, mechanism of injury, radiographic fracture classification, and surgical procedure were similar between the 2 groups. The FIB group consumed fewer morphine milligram equivalents before surgery (13 vs. 17, P = 0.04), had a trend toward an improved visual analog scale score on postoperative day 2 (0 vs. 2 P = 0.06), and walked a farther distance on postoperative day 2 (25' vs. 2', P = 0.09). A greater proportion of the FIB group were discharged home (50.9% vs. 32.5%, P = 0.05). There were no differences in opioid-related, block-related, or medical complications between groups. In the as-treated and per-protocol analyses, there were no significant differences.
CONCLUSIONS


A single perioperative FIB for patients with hip fractures undergoing surgery may decrease opioid consumption and increase the likelihood that a patient is discharged home.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"The FIB group consumed fewer MMEs prior to surgery (13 versus 17, p = 0.04), had a trend toward improved VAS on postop day (POD) 2 (0 versus 2 p = 0.06), and walked a farther distance POD 2 (25' versus 2 ' p = 0.09).","['group) from February 2018 to April 2019', 'patients undergoing surgery for hip fractures', 'Patients (N = 97) undergoing surgery for hip fractures', 'patients with hip fractures undergoing surgery', 'patients with hip fractures']","['perioperative FIB (FIB group) or receive no block (control', 'fascia iliaca block', 'fascia iliaca block (FIB']","['MMEs prior to surgery', 'pain, opioid consumption, and ambulation', 'visual analog score (VAS), morphine milligram equivalents (MME), post-operative ambulatory distance', 'opioid consumption', 'opioid-related, block-related, or medical complications']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0066662', 'cui_str': '1,2,3,4,9,9-hexachloro-1,4,4a,5,8,8a-hexahydro-6- methyl-6,7-epoxy-1,4-methanonaphthalene'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",97.0,0.0662857,"The FIB group consumed fewer MMEs prior to surgery (13 versus 17, p = 0.04), had a trend toward improved VAS on postop day (POD) 2 (0 versus 2 p = 0.06), and walked a farther distance POD 2 (25' versus 2 ' p = 0.09).","[{'ForeName': 'Spencer S', 'Initials': 'SS', 'LastName': 'Schulte', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Fernandez', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Van Tienderen', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Reich', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Adler', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Mai P', 'Initials': 'MP', 'LastName': 'Nguyen', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001795']
24,32353246,Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial.,"Rationale:  Excessive daytime sleepiness in patients with obstructive sleep apnea is associated with substantial burden of illness. Objectives:  To assess treatment effects of solriamfetol, a dopamine/norepinephrine reuptake inhibitor, on daily functioning, health-related quality of life, and work productivity in participants with obstructive sleep apnea and excessive daytime sleepiness as additional outcomes in a 12-week phase 3 trial (www.clinicaltrials.gov identifier NCT02348606). Methods:  Participants ( N  = 476) were randomized to solriamfetol 37.5, 75, 150, or 300 mg or to placebo. Outcome measures included the Functional Outcomes of Sleep Questionnaire short version, Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, and 36-item Short Form Health Survey version 2. A mixed-effects model with repeated measures was used for comparisons with placebo. Results:  Demographics, baseline disease characteristics, daily functioning, health-related quality of life, and work productivity were similar across groups. At Week 12, increased functioning and decreased impairment were observed with solriamfetol 150 and 300 mg (mean difference from placebo [95% confidence interval]) on the basis of Functional Outcomes of Sleep Questionnaire total score (1.22 [0.57 to 1.88] and 1.47 [0.80 to 2.13], respectively), overall work impairment (-11.67 [-19.66 to -3.69] and -11.75 [-19.93 to -3.57], respectively), activity impairment (-10.42 [-16.37 to -4.47] and -10.51 [-16.59 to -4.43], respectively), physical component summary (2.07 [0.42 to 3.72] and 1.91 [0.22 to 3.59], respectively), and mental component summary (150 mg only, 2.05 [0.14 to 3.96]). Common adverse events were headache, nausea, decreased appetite, and anxiety. Conclusions:  Solriamfetol improved measures of functioning, quality of life, and work productivity in participants with obstructive sleep apnea and excessive daytime sleepiness. Safety was consistent with previous studies.Clinical trial registered with www.clinicaltrials.gov (NCT02348606).",2020,"At week 12, increased functioning and decreased impairment were observed with solriamfetol 150 and 300 milligrams (mean difference from placebo [95% confidence interval]): Functional Outcomes of Sleep Questionnaire total score (1.22 [0.57, 1.88]) and (1.47 [0.80, 2.13], respectively), overall work impairment (-11.67 [-19.66, -3.69] and -11.75","['patients with obstructive sleep apnea', 'Participants (N=476', 'participants with obstructive sleep apnea and excessive daytime sleepiness']","['Solriamfetol', 'placebo']","['Functional Outcomes of Sleep Questionnaire short version, Work Productivity and Activity Impairment questionnaire for Specific Health Problem, and 36-Item Short Form Health Survey version 2', 'respectively) activity impairment ', 'functioning, quality of life, and work productivity', 'increased functioning and decreased impairment', 'Quality of Life Measures', 'headache, nausea, decreased appetite, and anxiety', 'overall work impairment', 'Demographics, baseline disease characteristics, daily functioning, health-related quality of life, and work productivity', 'daily functioning, health-related quality of life, and work productivity', 'Functional Outcomes of Sleep Questionnaire total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]","[{'cui': 'C4726765', 'cui_str': 'Solriamfetol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",476.0,0.19542,"At week 12, increased functioning and decreased impairment were observed with solriamfetol 150 and 300 milligrams (mean difference from placebo [95% confidence interval]): Functional Outcomes of Sleep Questionnaire total score (1.22 [0.57, 1.88]) and (1.47 [0.80, 2.13], respectively), overall work impairment (-11.67 [-19.66, -3.69] and -11.75","[{'ForeName': 'Terri E', 'Initials': 'TE', 'LastName': 'Weaver', 'Affiliation': 'University of Illinois at Chicago College of Nursing, Chicago, Illinois.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Henry Ford Hospital Sleep Disorders and Research Center, Detroit, Michigan.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Benes', 'Affiliation': 'Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stern', 'Affiliation': 'Advanced Respiratory and Sleep Medicine, PLLC, Huntersville, North Carolina.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Maynard', 'Affiliation': 'CTI Clinical Research Center, Cincinnati, Ohio.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Thein', 'Affiliation': 'Pacific Research Network, Evolution Research Group, LLC, San Diego, California.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Andry', 'Affiliation': 'Sleep Therapy & Research Center, San Antonio, Texas.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hudson', 'Affiliation': 'FutureSearch Trials of Neurology LP, Austin, Texas.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Bron', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Bogan', 'Affiliation': 'SleepMed, Inc., Columbia, South Carolina; and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202002-136OC']
25,31831845,Haploidentical transplantation might have superior graft-versus-leukemia effect than HLA-matched sibling transplantation for high-risk acute myeloid leukemia in first complete remission: a prospective multicentre cohort study.,"This study aimed to investigate graft-versus-leukemia (GVL) of haploidentical donor (HID) compared with HLA-matched sibling donor (MSD) for high-risk acute myeloid leukemia (H-AML) in first complete remission (CR1). One hundred and eighty-nine patients with H-AML in CR1 were enrolled in this multicentre prospective cohort study. Patients were assigned to groups transplanted with HID (n = 83) or MSD (n = 106) based on donor availability (biological randomization). The primary endpoint was the incidence of MRD positivity posttransplantation (post-MRD+). All post-MRD+ patients received preemptive interventions. The cumulative incidences of post-MRD+ were 18 and 42% in HID and MSD groups, respectively, (p < 0.001). Fifty-two patients received preemptive DLI, including 13 (16%) in HID and 39 cases (37%) in MSD groups (p = 0.001). Among HID and MSD groups, the 3-year cumulative incidence of relapse were 14 and 24% (p = 0.101); the 3-year cumulative incidence of treatment-related mortality were 15 and 10% (p = 0.368); the 3-year overall survival rates were 72 and 68% (p = 0.687); the 3-year disease-free-survival were 71 and 66% (p = 0.579); the 3-year graft-versus-host disease and relapse free survival were 63 and 43% (p = 0.035), respectively. HID might have a stronger GVL than MSD in H-AML patients. HID transplantation as postremission therapy should be recommended as one of the optimal choices for H-AML patients in CR1.",2020,"the 3-year graft-versus-host disease and relapse free survival were 63 and 43% (p = 0.035), respectively.",['One hundred and eighty-nine patients with H-AML in CR1'],"['HLA-matched sibling transplantation', 'Haploidentical transplantation', 'HLA-matched sibling donor (MSD', 'graft-versus-leukemia (GVL) of haploidentical donor (HID', 'MSD', 'preemptive interventions', 'preemptive DLI']","['incidence of MRD positivity posttransplantation (post-MRD', '3-year graft-versus-host disease and relapse free survival', '3-year cumulative incidence of treatment-related mortality', '3-year cumulative incidence of relapse', 'cumulative incidences of post-MRD', '3-year overall survival rates', '3-year disease-free-survival']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0056182', 'cui_str': 'Complement receptor CRI'}]","[{'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4505304', 'cui_str': 'Haploidentical Transplantation'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",189.0,0.0416837,"the 3-year graft-versus-host disease and relapse free survival were 63 and 43% (p = 0.035), respectively.","[{'ForeName': 'Sijian', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Peking University Institute of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, Fujian Institute of Hematology, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xuan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jieyu', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': ""Peking University Institute of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. xjhrm@medmail.com.cn.'}, {'ForeName': 'Qifa', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. liuqifa628@163.com.'}]",Leukemia,['10.1038/s41375-019-0686-3']
26,32361126,Kinetic parameters during land and water walking performed by individuals with Down Syndrome.,"BACKGROUND


Down Syndrome (DS) is a genetic condition presenting delay in acquisition of main motor milestones, such as walking. Although studies have been investigating the biomechanical parameters during land walking performed by individual with DS, the literature is scarce regarding kinetic parameters analysis in this population, specially during water walking.
RESEARCH QUESTION


This study sought to assess the vertical ground reaction force (Fz) of walking performed in water and on land at different speeds by individuals with DS.
METHODS


Fourteen adults with DS (age: 27.9 ± 7.9 years; body mass: 58.4 ± 12.9 kg; height: 1.4 ± 0.1 m, body mass index: 29.2 ± 5.4 kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment. The protocol consisted of walking performed at three self-selected speeds (slow, comfortable and fast) in randomized order. The Fz was assessed with a waterproof force plate in each condition. Two-way repeated-measures ANOVA (environment and speed), with Bonferroni's post hoc tests, were used for analysis. A significance level was set as α = 0.05.
RESULTS


Significant differences were observed between environments (p < 0.001), with reduced first peak of Fz (68-73%), second peak of Fz (66-70%), loading rate (75-78%) and impulse (40-41%) in the water walking for all speeds analyzed. In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking. Moreover, the loading rate significantly increased (p = 0.019) as the impulse significantly reduced (p < 0.001) in the higher speeds.
SIGNIFICANCE


Individuals with DS present reduced Fz outcomes during water walking in comparison to land. Therefore, water walking may be performed by individuals with DS with safe vertical loads on lower limbs regardless the self-selected speed for rehabilitation, correction of gait and training purposes.",2020,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","['individuals with DS', 'individuals with Down Syndrome', 'Individuals with DS present', 'Fourteen adults with DS (age: 27.9\u2009±\u20097.9 years; body mass: 58.4\u2009±\u200912.9\u2009kg; height: 1.4\u2009±\u20090.1\u2009m, body mass index: 29.2\u2009±\u20095.4\u2009kg.m -2 ) completed two sessions of data collection, one on land and another in aquatic environment']",['vertical ground reaction force (Fz) of walking performed in water and on land'],"['speed of walking', 'second peak of Fz', 'reduced Fz outcomes', 'loading rate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0563034', 'cui_str': 'Aquatic environment'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0231467,"In the aquatic environment, no significant difference was observed for the first and second Fz peaks with the increasing speed of walking.","[{'ForeName': 'Gabriela Neves', 'Initials': 'GN', 'LastName': 'Nunes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Stephanie Santana', 'Initials': 'SS', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Gabriele Randuz', 'Initials': 'GR', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Leonardo Alexandre', 'Initials': 'LA', 'LastName': 'Peyré-Tartaruga', 'Affiliation': 'Exercise Research Laboratory, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luana Siqueira', 'Initials': 'LS', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Graciele Ferreira', 'Initials': 'GF', 'LastName': 'Mendes', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Vitor de Lima', 'Initials': 'VL', 'LastName': 'Krüger', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Rochele Barboza', 'Initials': 'RB', 'LastName': 'Pinheiro', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Alexandre Carriconde', 'Initials': 'AC', 'LastName': 'Marques', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil.'}, {'ForeName': 'Cristine Lima', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': 'Federal University of Pelotas, Department of Sports, Pelotas, Brazil. Electronic address: tinialberton@yahoo.com.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.017']
27,32372568,Delayed meal timing after exercise is associated with reduced appetite and energy intake in adolescents with obesity.,"BACKGROUND


While the beneficial effects of exercise on appetite might depend on its timing during the day or relative to a meal, this remains poorly explored in youth.
OBJECTIVES


To examine the importance of meal timing (+30 vs +90 minutes) after performing exercise on energy intake, appetite and food reward in adolescents with obesity.
METHODS


Eighteen adolescents with obesity randomly completed three conditions: (a) lunch (12:00 pm) set 30 minutes after a rest session (11:00 am); (b) lunch (12:00 pm) set 30 minutes after an exercise session (11:00 am)(MEAL-30); (c) lunch (01:00 pm) set 90 minutes after an exercise session (11:00 am)(MEAL-90). Lunch and dinner ad libitum energy intake was assessed, food reward (LFPQ) assessed before and after lunch, and before dinner, appetite sensations were assessed at regular intervals.
RESULTS


Energy intake was lower at MEAL-90 than MEAL-30 and CON at lunch (P < .05 and P < .01, respectively) and lunch + dinner combined (P < .001). A decrease in intake (g) of protein, fat and carbohydrate was observed. Post-exercise hunger was lower on MEAL-90 compared with CON. No condition effects were found at lunch for food reward.
CONCLUSIONS


Delaying the timing of the meal after exercise might help affect energy balance by decreasing ad libitum energy intake without increasing hunger and by improving satiety in adolescents with obesity.",2020,"RESULTS


Energy intake was lower at MEAL-90 than MEAL-30 and CON at lunch (P < .05 and P < .01, respectively) and lunch + dinner combined (P < .001).","['adolescents with obesity', 'Eighteen adolescents with obesity randomly completed three conditions: (a']",['lunch (12:00 pm) set 30\u2009minutes after a rest session (11:00 am); (b) lunch (12:00 pm) set 30\u2009minutes after an exercise session (11:00 am)(MEAL-30); (c) lunch (01:00 pm'],"['Energy intake', 'intake (g) of protein, fat and carbohydrate', 'appetite and energy intake']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",18.0,0.0208892,"RESULTS


Energy intake was lower at MEAL-90 than MEAL-30 and CON at lunch (P < .05 and P < .01, respectively) and lunch + dinner combined (P < .001).","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'AME2P, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, Leeds, UK.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'AME2P, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Mélina', 'Initials': 'M', 'LastName': 'Bailly', 'Affiliation': 'AME2P, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, Leeds, UK.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Julian', 'Affiliation': 'CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics Unit (DRCI), Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'AME2P, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'AME2P, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'AME2P, Université Clermont Auvergne, F-63000 Clermont-Ferrand, France.'}]",Pediatric obesity,['10.1111/ijpo.12651']
28,32366288,Impact of Erythropoietin in the management of Hypoxic Ischaemic Encephalopathy in resource-constrained settings: protocol for a randomized control trial.,"BACKGROUND


Perinatal asphyxia, more appropriately known as hypoxic-ischemic encephalopathy (HIE), is a condition characterized by clinical and laboratory evidence of acute or sub-acute brain injury resulting from systemic hypoxemia and/or reduced cerebral blood flow. HIE is a common and devastating clinical condition in resource-poor countries with poor treatment outcome. This paper describes the protocol for an ongoing study that aims to evaluate the neuroprotective effects of Erythropoietin (EPO) as compared to routine care in the management of moderate to severe HIE among term infants.
METHODS


This study is a double-blind randomized controlled trial that will be conducted in the neonatal wards of the Lagos University Teaching Hospital (LUTH), Lagos, Nigeria, over a two-year period after ethical approvals and consents. One hundred and twenty-eight term newborns (≥ 37 weeks gestation) diagnosed with moderate/ severe HIE at admission will be allocated by randomization to receive either EPO or normal saline. All the participants will be offered standard care according to the unit protocol for HIE. Baseline investigations and close monitoring of the babies are done until discharge. Participants are followed up for 2 years to monitor their outcome (death or neurological development) using standard instruments.
DISCUSSION


Previous trials had shown that EPO confers neuroprotective benefits and improve neurological and behavioral outcome in infants with HIE both singly or as an adjuvant to therapeutic hypothermia. This study hypothesized that administering EPO to newborns with moderate /severe HIE can positively influence their clinical and neurological outcomes and will provide evidence to either support or disprove the usefulness of Erythropoietin as a sole agent in the treatment of HIE, especially in resource-limited environment with the highest burden of the disease.
TRIAL REGISTRATION


The study has been registered with the Pan African Clinical trials registry on the 2nd of December 2018, with registration number PACTR201812814507775.",2020,Previous trials had shown that EPO confers neuroprotective benefits and improve neurological and behavioral outcome in infants with HIE both singly or as an adjuvant to therapeutic hypothermia.,"['One hundred and twenty-eight term newborns (≥ 37\u2009weeks gestation) diagnosed with moderate/ severe HIE at admission', 'newborns with moderate /severe', 'moderate to severe HIE among term infants', 'neonatal wards of the Lagos University Teaching Hospital (LUTH), Lagos, Nigeria, over a two-year period after ethical approvals and consents']","['Erythropoietin', 'EPO', 'Erythropoietin (EPO', 'EPO or normal saline']",['neurological and behavioral outcome'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2712360', 'cui_str': 'Severe hypoxic ischemic encephalopathy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",128.0,0.298912,Previous trials had shown that EPO confers neuroprotective benefits and improve neurological and behavioral outcome in infants with HIE both singly or as an adjuvant to therapeutic hypothermia.,"[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Ezenwa', 'Affiliation': 'Neonatology unit, Department of Paediatrics, College of Medicine University of Lagos, Lagos, Nigeria. beatriceezenwa@yahoo.com.'}, {'ForeName': 'Chinyere', 'Initials': 'C', 'LastName': 'Ezeaka', 'Affiliation': 'Neonatology unit, Department of Paediatrics, College of Medicine University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Iretiola', 'Initials': 'I', 'LastName': 'Fajolu', 'Affiliation': 'Neonatology unit, Department of Paediatrics, College of Medicine University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ogbenna', 'Affiliation': 'Department of Haematology & Blood transfusion, College of Medicine University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Omodele', 'Initials': 'O', 'LastName': 'Olowoyeye', 'Affiliation': 'Department of Radiodiagnosis, College of Medicine University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Obiyo', 'Initials': 'O', 'LastName': 'Nwaiwu', 'Affiliation': 'Department of Pharmacology, Therapeutics &Toxicology, College of Medicine University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Opoola', 'Affiliation': 'Department of Paediatrics, Lagos University Teaching Hospital, Lagos, Nigeria.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Olorunfemi', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Witwatersrand, Johannesburg, South Africa.'}]",BMC neurology,['10.1186/s12883-020-01751-y']
29,32361367,Feasibility of a text-based reduction intervention in helping rural and underserved smokeless tobacco users quit.,"INTRODUCTION


Smokeless tobacco (ST) use significantly affects morbidity and mortality and remains disproportionally prevalent in rural and medically underserved communities. Few programs exist for rural smokeless tobacco users. Text-based interventions may increase the reach of cessation interventions; yet, none has tested them in ST users. We evaluated the feasibility, acceptability, and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) intervention in rural and underserved ST users.
METHODS


ST users were randomized in 2:1 fashion to the SGR group (N = 65), a text-based reduction program plus text-based support counseling messages or text-based support messages only group (N = 33). We surveyed participants at 30-days post intervention initiation to assess feasibility and acceptability and examined self-report 7-day point prevalence cessation at 30-days and 6-months post intervention initiation in the two arms.
RESULTS


We achieved benchmarks for feasibility and acceptability. Among the SGR participants 51% (n = 48) reported that intervention was useful in helping them quit, 83% (n = 48) indicated that they would recommend the intervention to a friend. Over 95% (n = 39) of SGR participants said that they read all alert texts. The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect). However, the quit rate at 6-months was 21% (p = 0.9703) for both groups.
CONCLUSIONS


A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted.",2020,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","['helping rural and underserved smokeless tobacco users quit', 'rural and underserved ST users', 'rural and medically underserved communities', 'rural smokeless tobacco users', 'ST users']","['text-based Scheduled Gradual Reduction (SGR) intervention', 'text-based reduction intervention', 'Smokeless tobacco (ST', 'text-based reduction program plus text-based support counseling messages or text-based support messages only group', 'SGR']","['feasibility and acceptability and examined self-report 7-day point prevalence cessation', 'feasibility and acceptability', 'quit rate']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",51.0,0.0567251,"The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect).","[{'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States. Electronic address: devon.noonan@duke.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Community and Family Medicine, 2424 Erwin Rd, Suite 602, Durham, NC 27710, United States.'}, {'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Peter', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Cherie', 'Initials': 'C', 'LastName': 'Conley', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, 307 Trent Drive, Durham, NC 27710, United States; University of California, Davis, Department of Human Ecology, 301 Shields Avenue, Davis, CA 95616, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Dr, Eugene, OR 97403, United States.'}, {'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Insitute, 20 Duke Medicine Cir, Durham, NC 27710, United States; Duke University School of Medicine, Department of Pupulation Health Sciences, 2424 Erwin Road Suite 602, Durham, NC 27710, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106434']
30,32362510,Cluster Randomized Trial of a College Health Center Sexual Violence Intervention.,"INTRODUCTION


Sexual violence, particularly in the context of drinking, is prevalent on college campuses. This study tested a brief intervention to prevent sexual violence among students receiving care from college health centers.
STUDY DESIGN


This study was a two-arm, unblinded cluster RCT.
SETTING/PARTICIPANTS


On 28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers completed surveys before the appointment, immediately after, 4 months later, and 12 months later.
INTERVENTION


Intervention college health center staff received training on delivering sexual violence education to all students seeking care. Control sites provided information about drinking responsibly.
MAIN OUTCOME MEASURES


The primary outcome was students' change in recognition of sexual violence. Additional outcomes included sexual violence disclosure and use of services among students with a history of sexual violence at baseline. Generalized linear mixed models accounting for campus-level clustering assessed intervention effects. Data were analyzed from September 2018 to June 2019.
RESULTS


Half (55%) of students seeking care at college health centers reported any history of sexual violence exposure. No between-group differences in primary (β=0.001, 95% CI= -0.04, 0.04) or secondary outcomes emerged between intervention and control students. Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants. Among those who reported sexual violence at baseline, intervention students had increased odds of disclosing violence during the visit (AOR=4.47, 95% CI=2.25, 8.89) in intensity-adjusted analyses compared with control. No between-group differences emerged for remaining outcomes.
CONCLUSIONS


Sexual violence exposure is high among students seeking care in college health centers. A brief provider-delivered sexual violence intervention, when implemented with fidelity, was associated with improved self-efficacy to use harm reduction and increased disclosure of sexual violence during clinical encounters but no increased use of services. More interventions that are stronger in intensity are needed to connect students to sexual violence services.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02355470.",2020,"Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants.","['Data were analyzed from September 2018 to June 2019', 'students seeking care in college health centers', 'students receiving care from college health centers', '28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers', 'College Health Center Sexual Violence Intervention']","['Intervention college health center staff received training on delivering sexual violence education to all students seeking care', 'sexual violence intervention']","[""students' change in recognition of sexual violence"", 'disclosing violence', 'sexual violence disclosure and use of services among students with a history of sexual violence', 'history of sexual violence exposure', 'self-efficacy', 'disclosure of sexual violence', 'sexual violence']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",2291.0,0.0525815,"Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Electronic address: elizabeth.miller@chp.edu.""}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'McCauley', 'Affiliation': 'School of Social Work, Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Rofey', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Psychiatry, Western Psychiatric Hospital, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Duncan B', 'Initials': 'DB', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Talis', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Jocelyn C', 'Initials': 'JC', 'LastName': 'Anderson', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; College of Nursing, Pennsylvania State University, State College, Pennsylvania.""}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Chugani', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Robert W S', 'Initials': 'RWS', 'LastName': 'Coulter', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Department of Behavioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.007']
31,32359142,Dose-response effects of dietary protein on muscle protein synthesis during recovery from endurance exercise in young men: a double-blind randomized trial.,"BACKGROUND


Protein ingestion increases skeletal muscle protein synthesis rates during recovery from endurance exercise.
OBJECTIVES


We aimed to determine the effect of graded doses of dietary protein co-ingested with carbohydrate on whole-body protein metabolism, and skeletal muscle myofibrillar (MyoPS) and mitochondrial (MitoPS) protein synthesis rates during recovery from endurance exercise.
METHODS


In a randomized, double-blind, parallel-group design, 48 healthy, young, endurance-trained men (mean ± SEM age: 27 ± 1 y) received a primed continuous infusion of l-[ring-2H5]-phenylalanine, l-[ring-3,5-2H2]-tyrosine, and l-[1-13C]-leucine and ingested 45 g carbohydrate with either 0 (0 g PRO), 15 (15 g PRO), 30 (30 g PRO), or 45 (45 g PRO) g intrinsically l-[1-13C]-phenylalanine and l-[1-13C]-leucine labeled milk protein after endurance exercise. Blood and muscle biopsy samples were collected over 360 min of postexercise recovery to assess whole-body protein metabolism and both MyoPS and MitoPS rates.
RESULTS


Protein intake resulted in ∼70%-74% of the ingested protein-derived phenylalanine appearing in the circulation. Whole-body net protein balance increased dose-dependently after ingestion of 0, 15, 30, or 45 g protein (mean ± SEM: -0.31± 0.16, 5.08 ± 0.21, 10.04 ± 0.30, and 13.49 ± 0.55 μmol phenylalanine · kg-1 · h-1, respectively; P < 0.001). 30 g PRO stimulated a ∼46% increase in MyoPS rates (%/h) compared with 0 g PRO and was sufficient to maximize MyoPS rates after endurance exercise. MitoPS rates were not increased after protein ingestion; however, incorporation of dietary protein-derived l-[1-13C]-phenylalanine into de novo mitochondrial protein increased dose-dependently after ingestion of 15, 30, and 45 g protein at 360 min postexercise (0.018 ± 0.002, 0.034 ± 0.002, and 0.046 ± 0.003 mole percentage excess, respectively; P < 0.001).
CONCLUSIONS


Protein ingested after endurance exercise is efficiently digested and absorbed into the circulation. Whole-body net protein balance and dietary protein-derived amino acid incorporation into mitochondrial protein respond to increasing protein intake in a dose-dependent manner. Ingestion of 30 g protein is sufficient to maximize MyoPS rates during recovery from a single bout of endurance exercise.This trial was registered at trialregister.nl as NTR5111.",2020,30 g PRO stimulated a ∼46% increase in MyoPS rates (%/h) compared with 0 g PRO and was sufficient to maximize MyoPS rates after endurance exercise.,"['48 healthy, young, endurance-trained men (mean\xa0±\xa0SEM age: 27\xa0±\xa01 y) received a', 'young men']","['l-[1-13C]-phenylalanine and l-[1-13C]-leucine labeled milk protein after endurance exercise', 'dietary protein co-ingested with carbohydrate', 'dietary protein', 'Protein ingestion', 'primed continuous infusion of l-[ring-2H5]-phenylalanine, l-[ring-3,5-2H2]-tyrosine, and l-[1-13C]-leucine and ingested 45 g carbohydrate with either 0 (0 g PRO', 'endurance exercise']","['incorporation of dietary protein-derived l-[1-13C]-phenylalanine into de novo mitochondrial protein', 'muscle protein synthesis', 'whole-body protein metabolism, and skeletal muscle myofibrillar (MyoPS) and mitochondrial (MitoPS) protein synthesis rates', 'MyoPS rates', 'Blood and muscle biopsy samples', 'MitoPS rates']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]","[{'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0949610', 'cui_str': 'Mitochondrial Protein'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample'}]",,0.0582953,30 g PRO stimulated a ∼46% increase in MyoPS rates (%/h) compared with 0 g PRO and was sufficient to maximize MyoPS rates after endurance exercise.,"[{'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Churchward-Venne', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Philippe J M', 'Initials': 'PJM', 'LastName': 'Pinckaers', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Joey S J', 'Initials': 'JSJ', 'LastName': 'Smeets', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Milan W', 'Initials': 'MW', 'LastName': 'Betz', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Senden', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Joy P B', 'Initials': 'JPB', 'LastName': 'Goessens', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Annemie P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Rollo', 'Affiliation': 'Gatorade Sports Science Institute, Leicester, United Kingdom.'}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University Medical Center+, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa073']
32,32375100,Effect of the Smart Moms intervention on targeted mediators of change in child sugar-sweetened beverage intake.,"OBJECTIVE


Few parent-targeted interventions have examined the mechanisms of action by which the intervention changes child behavior. The purpose of this study was to test the theoretical and behavioral mediators of the Smart Moms intervention on changes in child sugar-sweetened beverage and juice (SSB/juice) consumption.
STUDY DESIGN


This is a secondary mediation analysis of data from a 6-month randomized controlled trial (N = 51 mother-child dyads) of a mobile phone-based program to reduce child SSB/juice intake compared with a waitlist control group.
METHODS


Linear mixed models compared changes in intervention targets from baseline to 3 months between treatment groups. Intervention targets that changed significantly between groups were tested in a multiple mediation model to evaluate their significance as mediators of change in child SSB/juice at 6 months.
RESULTS


Maternal beverage consumption but no other behavioral or theoretical intervention targets mediated the effect of the intervention on the reduction in child SSB/juice at 6 months. There were few mediators of the intervention on child SSB/juice change.
CONCLUSION


Greater longitudinal research is needed to understand predictors of child dietary changes to inform future intervention efforts. In addition, a greater focus on the measurement of theoretical constructs in family-based child obesity prevention research is needed.",2020,"RESULTS


Maternal beverage consumption but no other behavioral or theoretical intervention targets mediated the effect of the intervention on the reduction in child SSB/juice at 6 months.",['child sugar-sweetened beverage intake'],"['mobile phone-based program to reduce child SSB/juice intake compared with a waitlist control group', 'Smart Moms intervention']",['child SSB/juice change'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",51.0,0.0406914,"RESULTS


Maternal beverage consumption but no other behavioral or theoretical intervention targets mediated the effect of the intervention on the reduction in child SSB/juice at 6 months.","[{'ForeName': 'B T', 'Initials': 'BT', 'LastName': 'Nezami', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA. Electronic address: bnezami@unc.edu.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Lytle', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA; Department of Health Behavior, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB #7440, Chapel Hill, NC 27599, USA. Electronic address: llytle@email.unc.edu.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA. Electronic address: dsward@email.unc.edu.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Ennett', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB #7440, Chapel Hill, NC 27599, USA. Electronic address: sennett@email.unc.edu.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill, 245 Rosenau Hall, CB #7461, Chapel Hill, NC 27599, USA; Department of Health Behavior, University of North Carolina at Chapel Hill, 302 Rosenau Hall, CB #7440, Chapel Hill, NC 27599, USA. Electronic address: dtate@unc.edu.'}]",Public health,['10.1016/j.puhe.2020.03.015']
33,32376872,"Correction: Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.",An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.114074,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0699-7']
34,32391156,Low-chloride- versus high-chloride-containing hypertonic solution for the treatment of subarachnoid hemorrhage-related complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial.,"Background


Recent reports have demonstrated that among patients with subarachnoid hemorrhage (SAH) treated with hypertonic NaCl, resultant hyperchloremia has been associated with the development of acute kidney injury (AKI). We report a trial comparing the effect of two hypertonic solutions with different chloride contents on the resultant serum chloride concentrations in SAH patients, with a primary outcome aimed at limiting chloride elevation.
Methods


A low ChloridE hyperTonic solution for brain Edema (ACETatE) trial is a single-center, double-blinded, double-dummy, randomized pilot trial comparing bolus infusions of 23.4% NaCl and 16.4% NaCl/Na-acetate for the treatment of cerebral edema in patients with SAH. Randomization occurred when patients developed hyperchloremia (serum Cl -  ≥ 109 mmol/L) and required hyperosmolar treatment.
Results


We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment. 15 patients were randomized to the 23.4% NaCl group, and 17 patients were randomized to the 16.4% NaCl/Na-acetate group. Although serum chloride levels increased similarly in both groups, the NaCl/Acetate group showed a significantly lower Cl -  load at the end of the study period (978mEq vs. 2,464mEq,  p  < 0.01). Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01). Both solutions had similar effects on ICP reduction, but NaCl/Acetate treatment had a more prominent effect on immediate post-infusion Na +  concentrations (increase of 2.2 ± 2.8 vs. 1.4 ± 2.6, ( p  < 0.01)). Proximal tubule renal biomarkers differed in concentration between the two groups.
Conclusions


Our pilot trial showed the feasibility and safety of replacing 23.4% NaCl infusions with 16.4% NaCl/Na-acetate infusions to treat cerebral edema in patients with SAH. The degree of hyperchloremia was similar in the two groups. 16.4% NaCl/Na-acetate infusions led to lower Cl -  load and AKI rates than 23.4% NaCl infusions. Further multi-center studies are needed to corroborate these results.
Trial registration


clinicaltrials.gov # NCT03204955, registered on 6/28/2017.",2020,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01).","['subarachnoid hemorrhage-related complications', 'We enrolled 59 patients, of which 32 developed hyperchloremia and required hyperosmolar treatment', 'SAH patients', '15 patients were randomized to the 23.4% NaCl group, and 17 patients', 'patients with SAH', 'patients with subarachnoid hemorrhage (SAH) treated with']","['hypertonic NaCl', 'low ChloridE hyperTonic solution', 'NaCl and 16.4% NaCl/Na-acetate', 'NaCl/Na-acetate group', 'NaCl infusions with 16.4% NaCl/Na-acetate infusions', 'Low-chloride- versus high-chloride-containing hypertonic solution', 'hypertonic solutions']","['degree of hyperchloremia', 'cerebral edema', 'ICP reduction', 'serum chloride levels', 'reduced rate of AKI', 'Cl -  load', 'feasibility and safety', 'immediate post-infusion Na +  concentrations', 'lower Cl -  load and AKI rates']","[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0860861', 'cui_str': 'Cl- decreased'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}, {'cui': 'C1959973', 'cui_str': 'Percent sodium chloride'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085679', 'cui_str': 'Hyperchloremia'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1317978', 'cui_str': 'Serum chloride measurement'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",59.0,0.317213,"Secondary outcome analysis revealed a reduced rate of AKI in the Na-acetate group (53.3% in the NaCl group vs. 11.8% in the Na-acetate group,  p  = 0.01).","[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Sadan', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Singbartl', 'Affiliation': '2Department of Critical Care Medicine, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ 85054 USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kraft', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Joao McONeil', 'Initials': 'JM', 'LastName': 'Plancher', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander C M', 'Initials': 'ACM', 'LastName': 'Greven', 'Affiliation': '3School of Medicine, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Kandiah', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Cederic', 'Initials': 'C', 'LastName': 'Pimentel', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Papangelou', 'Affiliation': '4Department of Anesthesiology, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Asbury', 'Affiliation': '5Department of Pharmacy, Emory University Hospital, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hanfelt', 'Affiliation': '6Department of Biostatistics and Bioinformatics, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Samuels', 'Affiliation': '1Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}]",Journal of intensive care,['10.1186/s40560-020-00449-0']
35,32389679,Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools.,"Solar ultraviolet radiation (UV) exposure is the primary risk factor for skin cancer and children receive about one-quarter of lifetime UV exposure before age 18. Thus, skin cancer prevention is essential for children. The objective of this study was to test an intervention to facilitate implementation of district sun safety policies. Elementary schools (N = 118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school. Elementary schools were randomly assigned to receive the 20-month Sun Safe Schools intervention (N = 58) or to a minimal informational control condition (N = 60). Principals were 47.8 and teachers 44.3 years of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2%). The 20-month Sun Safe Schools intervention was delivered to principals and included a coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program. The principal (N = 118) and a teacher (N = 113) at each school reported on school sun protection practices 20-months post-baseline. The schools were diverse in student characteristics (M = 64.1% free/reduced price meals; M = 54.5% Hispanic). Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control M = 0.4, intervention M = 0.9, p = .005). Principals and teachers combined replicated these findings and also reported implementing more practices present in the district policy (control M = 0.9, intervention M = 1.3, p = .005). In sum, the intervention increased sun safety practices in public elementary schools. Trial Registration. This study is registered in ClinicalTrials.gov, www.clinicaltrials.gov, with the identification number of NCT03243929.",2020,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","['Principals were 47.8 and teachers 44.3\u202fyears of age and were predominately female (principals 72.7%; teachers 86.7%) and White (principals 72.0%; teachers 68.2', 'California public elementary schools', 'Elementary schools (N\u202f=\u202f118) from 40 California public school districts with a school board-approved policy for sun safety were recruited along with one principal and teacher from each school', 'Elementary schools']","['Solar ultraviolet radiation (UV) exposure', '20-month Sun Safe Schools intervention (N\u202f=\u202f58) or to a minimal informational control condition', 'coaching session, telephone and email contacts, provision of resources for practice implementation, and a small grant program']","['sun safety practices', 'sun safety practices overall']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0636129,"Intervention principals reported implementing more sun safety practices overall (control M = 2.7, intervention M = 4.2, p < .005) and more practices not present in the district's policy (control","[{'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Reynolds', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA. Electronic address: Kim.Reynolds@cgu.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Massie', 'Affiliation': 'School of Community & Global Health, Claremont Graduate University, 675 W, Foothill Blvd., Ste. 200, Claremont, CA 91711, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Ashley', 'Affiliation': 'Sun Safety for Kids, 2625 W. Alameda Ave., Suite 517, Burbank, CA 91505, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR 97227, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106125']
36,32394219,The Effects of Acceptance and Commitment Therapy (ACT) Intervention on Inflammation and Stress Biomarkers: a Randomized Controlled Trial.,"BACKGROUND


Psychological processes can be manifested in physiological health. We investigated whether acceptance and commitment therapy (ACT), targeted on psychological flexibility (PF), influences inflammation and stress biomarkers among working-age adults with psychological distress and overweight/obesity.
METHOD


Participants were randomized into three parallel groups: (1) ACT-based face-to-face (n = 65; six group sessions led by a psychologist), (2) ACT-based mobile (n = 73; one group session and mobile app), and (3) control (n = 66; only the measurements). Systemic inflammation and stress markers were analyzed at baseline, at 10 weeks after the baseline (post-intervention), and at 36 weeks after the baseline (follow-up). General PF and weight-related PF were measured with questionnaires (Acceptance and Action Questionnaire, Acceptance and Action Questionnaire for Weight-Related Difficulties).
RESULTS


A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers. hsCRP decreased significantly in the face-to-face group from week 0 to week 36, and at week 36, hsCRP was lower among the participants in the face-to-face group than in the mobile group (p = .035, post hoc test). Age and sex were stronger predictors of biomarker levels at follow-up than the post-intervention PF.
CONCLUSION


The results suggest that ACT delivered in group sessions may exert beneficial effects on low-grade systemic inflammation. More research is needed on how to best apply psychological interventions for the health of both mind and body among people with overweight/obesity and psychological distress.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01738256, Registered 17 August, 2012.",2020,A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers.,"['Participants', 'working-age adults with psychological distress and overweight/obesity', 'people with overweight/obesity and psychological distress']","['acceptance and commitment therapy (ACT', 'ACT-based face-to-face (n\u2009=\u200965; six group sessions led by a psychologist), (2) ACT-based mobile (n\u2009=\u200973; one group session and mobile app', 'Acceptance and Commitment Therapy (ACT) Intervention', 'ACT']","['hsCRP', 'Inflammation and Stress Biomarkers', 'high-sensitivity C-reactive protein (hsCRP) level', 'General PF and weight-related PF', 'low-grade systemic inflammation', 'questionnaires (Acceptance and Action Questionnaire, Acceptance and Action Questionnaire for Weight-Related Difficulties', 'Systemic inflammation and stress markers']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.112618,A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers.,"[{'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Järvelä-Reijonen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland. elina.jarvela-reijonen@uef.fi.'}, {'ForeName': 'Sampsa', 'Initials': 'S', 'LastName': 'Puttonen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O. Box 40, FI-00251, Helsinki, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Karhunen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Sairanen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Laitinen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O. Box 40, FI-00251, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'Department of Environmental and Biological Sciences, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Pihlajamäki', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Korpela', 'Affiliation': 'Medical Faculty, Pharmacology, Medical Nutrition Physiology and Human Microbe Research Program, University of Helsinki, P.O. Box 63, FI-00014, Helsinki, Finland.'}, {'ForeName': 'Miikka', 'Initials': 'M', 'LastName': 'Ermes', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Marjukka', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09891-8']
37,32304308,"Corrigendum to: The effects of a 12-week jump rope exercise program on body composition, insulin sensitivity, and academic self-efficacy in obese adolescent girls.",,2020,,['obese adolescent girls'],['jump rope exercise program'],"['body composition, insulin sensitivity, and academic self-efficacy']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0128832,,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Chonnam National University, Gwangju, Republic of Korea.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Noble', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Health and Kinesiology, University of Nebraska at Omaha, Omaha, NE, USA.'}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2020-2132']
38,32308903,Timing Considerations for Noninvasive Vagal Nerve Stimulation in Clinical Studies.,"Noninvasive vagal nerve stimulation (n-VNS) devices have the potential for widespread applicability in improving the well-being of patients with stress-related psychiatric disorders. n-VNS devices are known to affect physiological signals, and, recently, they have been employed in various protocols involving both acute and longitudinal applications. However, questions regarding response time, ""dosage,"" or optimal treatment paradigms remain open. Prior work evaluated noninvasively obtained biomarkers that quantify the stimulation efficacy based on the changes in autonomic tone in a randomized double-blind study. In this work, we extend the state-of-the-art by investigating the onset of action for n-VNS in these same physiological biomarkers through a three-day clinical trial, including 233 administrations on 24 human participants, with and without immediately preceding acute traumatic stress. Determining n-VNS latency serves as a substantial step toward optimizing stimulation delivery with higher temporal resolution for personalized neuromodulation.",2019,Noninvasive vagal nerve stimulation (n-VNS) devices have the potential for widespread applicability in improving the well-being of patients with stress-related psychiatric disorders.,"['patients with stress-related psychiatric disorders', '24 human participants, with and without immediately preceding acute traumatic stress']",['Noninvasive vagal nerve stimulation (n-VNS'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]",[],24.0,0.0486448,Noninvasive vagal nerve stimulation (n-VNS) devices have the potential for widespread applicability in improving the well-being of patients with stress-related psychiatric disorders.,"[{'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Asim H', 'Initials': 'AH', 'LastName': 'Gazi', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Scott', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA.'}]",AMIA ... Annual Symposium proceedings. AMIA Symposium,[]
39,32374527,A Secondary Data Analysis Examining Young Adults' Performance in an Internet Weight Loss Program with Financial Incentives.,"OBJECTIVE


In traditional behavioral weight loss (BWL) programs, young adults fare worse than older adults with respect to engagement, retention, and weight loss, but money and use of technology have been cited as program factors that might improve outcomes for this population. This study evaluated young adult performance in internet-based BWL (IBWL) offering financial incentives for self-monitoring and weight loss.
METHODS


Participants (N = 180; BMI = 33.2 ± 6.0 kg/m 2  ) were randomly assigned to a 12-week IBWL or IBWL + incentives (IBWL + $) group. This secondary data analysis compared young adults (ages 18-35) in IBWL (n = 16) with young adults in IBWL + $ (n = 12) on percent weight loss, engagement, and retention. Young adults (n = 28) were also compared with older adults (ages 36-70; n = 152) on these outcomes.
RESULTS


Young adult weight loss was -2.8% ± 5.2% in IBWL and -5.4% ± 5.7% in IBWL + $ (P = 0.23, partial η 2   = 0.06). A greater proportion of young adults in IBWL + $ achieved a 10% weight loss compared with IBWL (42% vs. 6%, P = 0.02). Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
CONCLUSIONS


Findings suggest that technology-based BWL has the potential to eliminate weight loss disparities observed between young adults and older adults in in-person BWL trials. Moreover, adding financial incentives holds promise for promoting clinically meaningful weight loss for young adults.",2020,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","['young adults', 'Participants (N\u2009=\u2009180; BMI\u2009=\u200933.2\u2009±\u20096.0 kg/m 2  ', 'young adults and older adults', 'young adults fare worse than older adults', 'Young adults (n\u2009=\u200928) were also compared with older adults (ages 36-70; n\u2009=\u2009152) on these outcomes', 'young adults (ages 18-35) in IBWL (n\u2009=\u200916) with young adults in IBWL\u2009+\u2009$ (n\u2009=\u200912) on percent weight loss, engagement, and retention']","['technology-based BWL', 'IBWL or IBWL\u2009+\u2009incentives (IBWL\u2009+\u2009$) group', 'traditional behavioral weight loss (BWL) programs']","['weight loss', 'retention or weight loss']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0386472,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Services, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reading', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, Miriam Hospital, Providence, Rhode Island, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22797']
40,32370582,Measuring Hidden Support for Physical Intimate Partner Violence: A List Randomization Experiment in South-Central Ethiopia.,"Understanding how and why physical intimate partner violence (IPV) persists in high-risk communities has proven difficult. As IPV is both sensitive and illegal, people may be inclined to misreport their views and experiences. By embedding a list randomization experiment (LRE), which increases respondent privacy, in a survey of 809 adult Arsi Oromo men and women in rural south-central Ethiopia, we test the reliability of direct questioning survey methods (e.g., used in the Demographic and Health Surveys) for measuring attitudes that underpin the acceptability of IPV. Participants were randomly assigned versions of the survey in which they were asked either directly or indirectly about the acceptability of wife-beating. By comparing responses across these surveys, we identify the extent to which views are being misreported using direct questioning methods, as well as identifying the ""true"" predictors of continued support for wife-beating. Indirect questioning reveals that almost one third of the sample believe that wife-beating is acceptable. Adults (particularly men) who are less educated (<3 years schooling) or living in households where women do not participate in economic decision making are among those most likely to identify wife-beating as justifiable (>50% endorsement). These individuals, however, are also more inclined to hide their approval when asked directly by an interviewer. That we find high but underreported support for wife-beating among some members of the community demonstrates a clear need to encourage a more open dialogue, to prevent violence toward women remaining undetected and thus unchanged. This finding also raises questions about the accuracy of traditional direct questioning for capturing information on IPV attitudes and norms. Of relevance to policy, we find that wife-beating is entirely absent only among adults with higher levels of education, living in households where decision making is shared between couples.",2020,"Of relevance to policy, we find that wife-beating is entirely absent only among adults with higher levels of education, living in households where decision making is shared between couples.","['South-Central Ethiopia', 'Physical Intimate Partner Violence', 'Adults (particularly men) who are less educated (<3 years schooling) or living in households where women', '809 adult Arsi Oromo men and women in rural south-central Ethiopia']",[],[],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0574158', 'cui_str': 'Oromo language'}]",[],[],809.0,0.022376,"Of relevance to policy, we find that wife-beating is entirely absent only among adults with higher levels of education, living in households where decision making is shared between couples.","[{'ForeName': 'Mhairi A', 'Initials': 'MA', 'LastName': 'Gibson', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Eshetu', 'Initials': 'E', 'LastName': 'Gurmu', 'Affiliation': 'Addis Ababa University, Ethiopia.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Cobo', 'Affiliation': 'University of Granada, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Rueda', 'Affiliation': 'University of Granada, Spain.'}, {'ForeName': 'Isabel M', 'Initials': 'IM', 'LastName': 'Scott', 'Affiliation': 'University of Bristol, UK.'}]",Journal of interpersonal violence,['10.1177/0886260520914546']
41,32312527,"Response to Letter to the Editor re 'Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial'.",,2020,,[],['cryotherapy'],[],[],"[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",[],,0.0262864,,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Estéfani', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ruschel', 'Affiliation': 'University of the State of Santa Catarina - Health and Sports Science Centre (CEFID/UDESC), Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Inaihá Laureano', 'Initials': 'IL', 'LastName': 'Benincá', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Núbia Carelli Pereira', 'Initials': 'NCP', 'LastName': 'de Avelar', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Daniela Pacheco', 'Initials': 'DP', 'LastName': 'Dos Santos Haupenthal', 'Affiliation': 'University of the Extreme South of Santa Catarina - Laboratory of cellular and molecular biology (LABIM/UNESC), Criciúma, Santa Catarina, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Haupenthal', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil. Electronic address: alessandro.haupenthal@ufsc.br.'}]",Physiotherapy,['10.1016/j.physio.2020.02.006']
42,32376326,Family History Influences the Effectiveness of Home Exercise in Older People With Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE


To investigate whether a family history of low back pain (LBP) influences patient outcomes and treatment effects following home exercises in older people with chronic LBP.
DESIGN


Secondary analysis of a randomized controlled trial.
SETTING


Local community.
PARTICIPANTS


People older than 55 years with chronic LBP (N=60).
INTERVENTIONS


Participants in the intervention group completed video game exercises for 60 minutes 3 times per week for 8 weeks. Participants in the control group were instructed to maintain their usual levels of activity and care seeking behaviors.
MAIN OUTCOMES MEASURES


Participants indicated whether any of their immediate family members had a history of ""any"" LBP or ""activity-limiting"" LBP at baseline. We collected self-reported measures of pain, function, pain self-efficacy, care seeking, physical activity, disability, fear of movement and/or reinjury, and falls efficacy at baseline, 8 weeks, 3 months, and 6 months. We performed regression analyses to determine whether a family history of LBP predicted patient outcomes and moderated the effects of home exercise.
RESULTS


Participants with a family history of any LBP were less likely to be highly active than those without a family history (odds ratio, 0.08; 95% CI, 0.01-0.42; P=.003). Home-based video game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78; 95% CI, 0.56-3.00; P=.006) but not in those with a family history (β=-0.17; 95% CI, -2.56 to 2.21; P=.880) (interaction P=.049). A family history of LBP did not influence the remaining patient outcomes or treatment effects.
CONCLUSIONS


A family history of LBP appears to negatively influence physical activity levels in older people with chronic LBP. Further, home-based video game exercises appear to be beneficial for older people with chronic LBP that do not have a family history of LBP.",2020,"Home-based video-game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78 95%CI: 0.56-3.00, p=0.006), but not in those with a family history (β=-0.17 95%CI: -2.56 to 2.21, p=0.880) (interaction p=0.049).","['older people with chronic LBP', 'Local community', 'People over 55 years old with chronic LBP', 'OF HOME-EXERCISE IN OLDER PEOPLE WITH CHRONIC LOW BACK PAIN']","['home-exercises', 'video-game exercises']","['pain, function, pain self-efficacy, care seeking, physical activity, disability, fear of movement/re-injury, and falls-efficacy', ""history of 'any' LBP or 'activity-limiting' LBP"", 'physical activity levels']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0788307,"Home-based video-game exercises led to improvements in function in those without a family history of activity-limiting LBP (β=1.78 95%CI: 0.56-3.00, p=0.006), but not in those with a family history (β=-0.17 95%CI: -2.56 to 2.21, p=0.880) (interaction p=0.049).","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Zadro', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, NSW, Australia. Electronic address: joshua.zadro@sydney.edu.au.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Shirley', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, NSW, Australia.'}, {'ForeName': 'Tom I L', 'Initials': 'TIL', 'LastName': 'Nilsen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway; Clinic of Anaesthesia and Intensive Care, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, NSW, Australia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.019']
43,32383964,Delirium Severity Trajectories and Outcomes in ICU Patients. Defining a Dynamic Symptom Phenotype.,"Rationale:  Delirium severity and duration are independently associated with higher mortality and morbidity. No studies to date have described a delirium trajectory by integrating both severity and duration. Objectives:  The primary aim was to develop delirium trajectories by integrating symptom severity and duration. The secondary aim was to investigate the association among trajectory membership, clinical characteristics, and 30-day mortality. Methods:  A secondary analysis of the PMD (Pharmacologic Management of Delirium) randomized control trial (ClinicalTrials.gov Identifier: NCT00842608;  N  = 531) was conducted. The presence of delirium and symptom severity were measured at least daily for 7 days using the Confusion Assessment Method for the intensive care unit (CAM-ICU) and CAM-ICU-7 (on a scale of 0-7, with 7 being the most severe). Delirium trajectories were defined using an innovative, data-driven statistical method (group-based trajectory modeling [GBTM]) and SAS v9.4. Results:  A total of 531 delirious participants (mean age 60 yr [standard deviation = 16], 55% female, and 46% African American) were analyzed. Five distinct delirium trajectories were described (CAM-ICU-7: mean [standard deviation]); mild-brief (CAM-ICU-7: 0.5 [0.5]), severe-rapid recovers (CAM-ICU-7: 2.1 [1.0]), mild-accelerating (CAM-ICU-7: 2.2 [0.9]), severe-slow recovers (CAM-ICU-7: 3.9 [0.9]), and severe-nonrecovers (CAM-ICU-7: 5.9 [1.0]). Baseline cognition and race were associated with trajectory membership. Trajectory membership independently predicted 30-day mortality while controlling for age, sex, race, cognition, illness severity, and comorbidities. Conclusions:  This secondary analysis described five distinct delirium trajectories based on delirium symptom severity and duration using group-based trajectory modeling. Trajectory membership predicted 30-day mortality.",2020,Trajectory membership predicted 30-day mortality.,"['531 delirious participants (mean age 60 years (SD 16), 55% female, and 46% African American', 'ICU Patients']",[],"['Mild-Accelerating', 'delirium and symptom severity', 'Severe-Rapid Recovers', 'Delirium trajectories', 'Severe-Slow Recovers', '30-day mortality', 'Mean (SD']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",531.0,0.0494442,Trajectory membership predicted 30-day mortality.,"[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lindroth', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep and Occupational Medicine.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep and Occupational Medicine.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Carpenter', 'Affiliation': 'School of Nursing, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Biostatistics, and.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Department of Biostatistics, and.'}, {'ForeName': 'Sikandar H', 'Initials': 'SH', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary, Critical Care, Sleep and Occupational Medicine.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Center for Health Innovation and Implementation Science.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University, Providence, Rhode Island; and.'}, {'ForeName': 'Malaz A', 'Initials': 'MA', 'LastName': 'Boustani', 'Affiliation': 'Center for Health Innovation and Implementation Science.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201910-764OC']
44,32387042,"Anti-inflammatory effects of lenabasum, a cannabinoid receptor type 2 agonist, on macrophages from cystic fibrosis.","BACKGROUND


Lenabasum is an oral synthetic cannabinoid receptor type 2 agonist previously shown to reduce the production of key airway pro-inflammatory cytokines known to play a role in cystic fibrosis (CF). In a double-blinded, randomized, placebo-control phase 2 study, lenabasum lowered the rate of pulmonary exacerbation among patients with CF. The present study was undertaken to investigate anti-inflammatory mechanisms of lenabasum exhibits in CF macrophages.
METHODS


We used monocyte-derived macrophages (MDMs) from healthy donors (n = 15), MDMs with CFTR inhibited with C-172 (n = 5) and MDMs from patients with CF (n = 4). Monocytes were differentiated to macrophages and polarized into classically activated (M1) macrophages by LPS or alternatively activated (M2) macrophages by IL-13 in presence or absence of lenabasum.
RESULTS


Lenabasum had no effect on differentiation, polarization and function of macrophages from healthy individuals. However, in CF macrophages lenabasum downregulated macrophage polarization into the pro-inflammatory M1 phenotype and secretion of the pro-inflammatory cytokines IL-8 and TNF-α in a dose-dependent manner. An improvement in phagocytic activity was also observed following lenabasum treatment. Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs. The effects of lenabasum on MDMs with CFTR inhibited by C-172 were not as obvious.
CONCLUSION


In CF macrophages lenabasum modulates macrophage polarization and function in vitro in a way that would reduce inflammation in vivo. Further studies are warranted to determine the link between activating the CBR2 receptor and CFTR.",2020,"Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs.","['healthy donors (n\xa0=\xa015), MDMs with CFTR inhibited with', 'patients with CF']","['C-172', 'placebo']","['rate of pulmonary exacerbation', 'differentiation, polarization and function of macrophages', 'phagocytic activity']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0429742,"Although lenabasum did not restore the impaired polarization of anti-inflammatory M2 macrophage, it reduced the levels of IL-13 and enhanced the endocytic function of CF MDMs.","[{'ForeName': 'Abdullah A', 'Initials': 'AA', 'LastName': 'Tarique', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Tama', 'Initials': 'T', 'LastName': 'Evron', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Tepper', 'Affiliation': 'Corbus Pharmaceuticals, Inc., Norwood, MA, USA.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Morshed', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Isabella S G', 'Initials': 'ISG', 'LastName': 'Andersen', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Nelufa', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sly', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia. Electronic address: p.sly@uq.edu.au.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fantino', 'Affiliation': 'Child Health Research Centre (CHRC), The University of Queensland, Brisbane, Australia.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.03.015']
45,32389383,Influence of an Audiovisual Resource on the Preoperative Anxiety of Adult Endodontic Patients: A Randomized Controlled Clinical Trial.,"INTRODUCTION


The expectation of undergoing endodontic treatment can cause anxiety in patients. Anxiety is described as a transient emotional state closely related to pain, fear, and imbalance of the organism. The clinician commonly must use some type of tool to alleviate the patient's preoperative anxiety before treatment can be applied. The aim of this study was to evaluate the influence of an audiovisual resource on the preoperative anxiety of adult patients undergoing endodontic treatment.
METHODS


One hundred sixty endodontic patients were randomly divided into experimental and control groups (n = 80) and then assessed at 2 preoperative time points separated by a 10-minute interval. After the first assessment, the patients in the experimental group watched a video of their own choice obtained from the Internet to provide them with a relaxing experience. In both groups and at both time points, the assessments consisted of collecting the patients' vital signs (diastolic blood pressure, systolic blood pressure, and heart rate) and data regarding their subjective perception of anxiety using a visual analog scale.
RESULTS


There were no significant differences between the groups regarding the vital sign variation observed between the 2 assessment time points. However, the variation in the scores obtained on the visual analog scale was significantly greater in the experimental group (P < .05), indicating a greater reduction in the level of preoperative anxiety in this group.
CONCLUSIONS


The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.",2020,The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.,"['patients undergoing endodontic treatment', 'adult patients undergoing endodontic treatment', 'Adult Endodontic Patients', 'patients', 'One hundred sixty endodontic patients']","['audiovisual resource', 'Audiovisual Resource']","['level of preoperative anxiety', 'visual analog scale', 'vital sign variation', 'vital signs (diastolic blood pressure, systolic blood pressure, and heart rate) and data regarding their subjective perception of anxiety using a visual analog scale', 'perception of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",160.0,0.0247464,The preoperative use of an audiovisual resource was associated with a decrease in the perception of anxiety by patients undergoing endodontic treatment.,"[{'ForeName': 'Marco André', 'Initials': 'MA', 'LastName': 'Craveiro', 'Affiliation': 'Discipline of Endodontics, Department of Restorative Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: andre.craveiro@usp.br.'}, {'ForeName': 'Celso Luiz', 'Initials': 'CL', 'LastName': 'Caldeira', 'Affiliation': 'Discipline of Endodontics, Department of Restorative Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.03.024']
46,32332827,40-Hz Binaural beats enhance training to mitigate the attentional blink.,"This study investigated whether binaural beat stimulation could accelerate the training outcome in an attentional blink (AB) task. The AB refers to the lapse in detecting a target T2 in rapid serial visual presentation (RSVP) after the identification of a preceding target T1. Binaural beats (BB) are assumed to entrain neural oscillations and support cognitive function. Participants were assigned into two groups and presented with BB sounds while performing the AB task on three subsequent days in a cross-over design. Group A was presented with 40-Hz BB during the first day and 16 Hz during the second day, while the order of beat frequencies was reversed in Group B. No sound was presented on the third day. MEG recordings confirmed a strong entrainment of gamma oscillations during 40-Hz BB stimulation and smaller gamma entrainment with 16-Hz BB. The rhythm of the visual stimulation elicited 10-Hz oscillations in occipital MEG sensors which were of similar magnitude for both BB frequencies. The AB performance did not increase within a session. However, participants improved between sessions, with overall improvement equal in both groups. Group A improved more after the first day than the second day. In contrast, group B gained more from the 40 Hz stimulation on the second day than from 16-Hz stimulation on the first day. Taken together, 40-Hz BB stimulation during training accelerates the training outcome. The improvement becomes evident not immediately, but after consolidation during sleep. Therefore, auditory beats stimulation is a promising method of non-invasive brain stimulation for enhancing training and learning which is well-suited to rehabilitation training.",2020,MEG recordings confirmed a strong entrainment of gamma oscillations during 40-Hz BB stimulation and smaller gamma entrainment with 16-Hz BB.,[],['40-Hz Binaural beats enhance training'],"['AB performance', '40-Hz BB stimulation', 'attentional blink (AB) task', '40-Hz BB', 'Binaural beats (BB']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1955945', 'cui_str': 'Attentional Blink'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",,0.0249212,MEG recordings confirmed a strong entrainment of gamma oscillations during 40-Hz BB stimulation and smaller gamma entrainment with 16-Hz BB.,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ross', 'Affiliation': 'Rotman Research Institute, Baycrest Centre for Geriatric Care, Toronto, Ontario, M6A 2E1, Canada. bross@research.baycrest.org.'}, {'ForeName': 'Marc Danzell', 'Initials': 'MD', 'LastName': 'Lopez', 'Affiliation': 'Rotman Research Institute, Baycrest Centre for Geriatric Care, Toronto, Ontario, M6A 2E1, Canada.'}]",Scientific reports,['10.1038/s41598-020-63980-y']
47,32394625,"Corrigendum to ""Models of Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval for Healthy Subjects Who Received Placebo in Phase I Trials"".",,2020,,['Healthy Subjects'],['Placebo'],"['Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.0401805,,[],Clinical and translational science,['10.1111/cts.12773']
48,32338067,Glycine Max (L.)  Merr isoflavone gel improves vaginal vascularization in postmenopausal women.,"Objective:  This study aimed to analyze the effects of isoflavones from  Glycine max (L.)  Merr (soy) used topically as a vaginal gel on the induction of vascularization of the vaginal tissue in postmenopausal women. Study design:  A placebo-controlled, randomized, double-blind trial was conducted with 22 postmenopausal women, randomly allocated for treatment with  Glycine max (L.)  Merr isoflavone 4% vaginal gel daily for 12 weeks or with placebo gel for the same period. Main outcome measure:  Vaginal microbiopsies were collected before and after the 12-week treatment. Immunohistochemistry analyses were performed to provide a blood vessel count per field in the vaginal tissue, pre and post intervention. Results:  The isoflavone group exhibited a significant increase in blood vessels per field relative to baseline, whereas the placebo group showed no difference compared to baseline. There was a significant difference in the increase of the number of blood vessels between the isoflavone and placebo groups. Conclusion:  The results showed that local administration of  Glycine max (L.)  Merr isoflavone gel promoted a significant improvement in the number of blood vessels in the vaginal tissue of postmenopausal women.",2020,There was a significant difference in the increase of the number of blood vessels between the isoflavone and placebo groups.,"['22 postmenopausal women', 'postmenopausal women']","['isoflavone', 'placebo', 'Glycine Max (L.)  Merr isoflavone gel', 'Glycine max (L.)  Merr isoflavone gel', 'isoflavones from  Glycine max (L.)  Merr (soy', 'Glycine max (L.)  Merr isoflavone 4% vaginal gel daily for 12\u2009weeks or with placebo gel']","['Vaginal microbiopsies', 'number of blood vessels', 'blood vessels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",22.0,0.334028,There was a significant difference in the increase of the number of blood vessels between the isoflavone and placebo groups.,"[{'ForeName': 'S M R R', 'Initials': 'SMRR', 'LastName': 'Lima', 'Affiliation': 'Endocrine Gynecology and Climacteric Department, Irmandade Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Honorato', 'Affiliation': 'Endocrine Gynecology and Climacteric Department, Irmandade Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'M A L G', 'Initials': 'MALG', 'LastName': 'Silva', 'Affiliation': 'Department of Pathology, Irmandade Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1752172']
49,32334955,Assessing an App-Based Child Restraint System Use Intervention in China: An RCT.,"INTRODUCTION


While child restraint systems are effective in protecting children from crash-related injuries and deaths, their use in China is extremely low. This study assessed the effectiveness of child restraint system education with and without behavioral skills training on improved use and explored participants' views regarding content and delivery of an onsite intervention and online (WeChat) boosters.
STUDY DESIGN


A randomized trial was conducted in 6 kindergartens from May 2017 to January 2018 in Shantou and Chaozhou, China. Selected kindergartens were randomly assigned to 3 groups: (1) control, (2) child restraint system education‒only, and (3) child restraint system education plus behavioral skills training. Analysis was conducted in May 2018.
SETTING/PARTICIPANTS


Participants were parents from the selected kindergartens.
INTERVENTION


Both intervention groups received child restraint system education that included one-time onsite education and biweekly online boosters for 3 months using an app to deliver education messages.
MAIN OUTCOME MEASURES


Survey questions included parent knowledge, attitude and behaviors of child restraint system use, and opinions related to the content and delivery of the onsite intervention and online boosters.
RESULTS


Child restraint system use in both intervention groups was higher than that of the control group post-intervention (27.3% and 31.7%, respectively). Compared with the control group, the intervention groups had a higher percentage of correct answers to all 9 items, except Item 7 measuring the parents' knowledge, attitude, and behaviors of child passenger safety after the intervention. Lower parent's level of education (OR=7.00, 95% CI=2.62, 18.70) and older child age (4 years: OR=3.92, 95% CI=1.08, 5.28; 5 years: OR=2.08, 95% CI=1.52, 5.31) were associated with lower rates of child restraint system use. Most parents (92.3%) preferred the online over the onsite intervention component.
CONCLUSIONS


An education intervention was effective in improving parents' knowledge, attitude, and practice of child restraint system use. A social media intervention booster (WeChat) may provide a new channel to help promote child passenger safety in China.",2020,"Compared with the control group, the intervention groups had a higher percentage of correct answers to all 9 items, except Item 7 measuring the parents' knowledge, attitude, and behaviors of child passenger safety after the intervention.","['China', '6 kindergartens from May 2017 to January 2018 in Shantou and Chaozhou, China', 'older child age (4 years', 'Participants were parents from the selected kindergartens']","['onsite intervention and online (WeChat) boosters', 'control, (2) child restraint system education‒only, and (3) child restraint system education plus behavioral skills training', 'child restraint system education with and without behavioral skills training', 'App-Based Child Restraint System Use Intervention', 'child restraint system education that included one-time onsite education and biweekly online boosters for 3 months using an app to deliver education messages', 'education intervention']","['parent knowledge, attitude and behaviors of child restraint system use, and opinions related to the content and delivery of the onsite intervention and online boosters', ""parents' knowledge, attitude, and practice of child restraint system use"", ""parents' knowledge, attitude, and behaviors of child passenger safety""]","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1319152', 'cui_str': 'Knowledge level: parenting'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0450048', 'cui_str': 'Passenger'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0339503,"Compared with the control group, the intervention groups had a higher percentage of correct answers to all 9 items, except Item 7 measuring the parents' knowledge, attitude, and behaviors of child passenger safety after the intervention.","[{'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Jingzhen', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Center for Injury Research and Policy, Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Jingmei', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Kele', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Health Sciences, Kent State University, Kent, Ohio.'}, {'ForeName': 'Wanbao', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Injury Prevention Research Center, Shantou University Medical College, Shantou, China. Electronic address: lpli@stu.edu.cn.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.003']
50,32335056,Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.,"PURPOSE


To compare the incidence and intensity of posterior capsule opacification (PCO) and neodymium-yttrium-aluminum-garnet (Nd:YAG) capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) that differ in the proprietary material characteristics and design features, over a period of 3 years.
DESIGN


Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison.
METHODS


Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
PATIENT POPULATION


Eighty patients (160 eyes) had bilateral cataract surgery and received a Vivinex XY1 IOL in 1 eye and an AcrySof SN60WF IOL in the other eye.
OBSERVATION PROCEDURES


Follow-up examinations were performed 3 years after surgery. Digital retroillumination images were taken of each eye. The amount of PCO (score: 0-10) was assessed subjectively at the slit lamp and objectively using automated image analysis software (AQUA).
MAIN OUTCOME MEASURE


PCO score (scale, 0-10).
RESULTS


The mean objective PCO score of the Vivinex XY1 IOLs was 0.9 ± 0.8 compared to the PCO score of 1.4 ± 1.1 for the AcrySof SN60WF IOLs (P < .001). Three years postoperatively, 11.4% of patients had an Nd:YAG capsulotomy in the Vivinex XY1 eye and 18.6% had a capsulotomy in the AcrySof SN60WF eye (P = .23).
CONCLUSION


The new hydrophobic acrylic Vivinex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the AcrySof SN60WF IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge plays a key role in PCO development.",2020,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,[' Eighty patients (160 eyes) had bilateral cataract surgery and received a'],"['posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates between two similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs', 'Vivinex XY1 IOL in one eye and an Acrysof SN60WF IOL in the other eye', 'hydrophobic acrylic intraocular lenses', 'neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy']","['PCO rates and lower YAG rates', 'mean objective PCO score', 'Posterior capsule opacification score (scale, 0-10']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.147149,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Röggla', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Electronic address: rupert.menapace@meduniwien.ac.at.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.011']
51,32383574,Randomized comparison of functional electric stimulation in posturally corrected position and motor program activating therapy: treating foot drop in people with multiple sclerosis.,"BACKGROUND


Functional electric stimulation (FES) is recommended for foot drop in multiple sclerosis, although little is known about its therapeutic effect.
AIM


The aim of this study is to evaluate a therapeutic effect immediately and two months after program termination (persistent and delayed effect) of a new approach using FES in combination with correcting the patients' postural system. More specifically, we evaluate the effects of this approach on the patients' clinical functions and compared it with individual physiotherapy.
DESIGN


Parallel randomized blind trial.
SETTING


Two-month-long treatments, functional electric stimulation in posturally corrected position (group 1) and neuroproprioceptive facilitation and inhibition physiotherapy called motor program activating therapy (group 2).
POPULATION


Forty-four subjects with multiple sclerosis.
METHODS


Primary outcomes: gait (the 2-Minute Walk Test; Timed 25-Foot Walk test; Multiple Sclerosis Walking Scale-12) and balance (by e.g. Berg Balance Scale [BBS], the Activities-Specific Balance Confidence Scale [ABC], Timed Up-and-Go Test [TUG]).
SECONDARY OUTCOMES


mobility, cognition, fatigue and subjects' perceptions (e.g. Multiple Sclerosis Impact Scale [MSIS], Euroqol-5 dimensions-5 levels [EQ-5D-5L]).
RESULTS


Group 1 showed immediate therapeutic effect in BBS (P=0.008), ABC (P=0.04) and EQ-5D-5L (self-care, P=0.019, mobility P=0.005). The improvement in EQ-5D-5L persisted and in TUG-cognitive we documented a delayed effect (P=0.005). Group 2 showed an immediate improvement in BBS (P=0.025), MSIS (P=0.043) and several aspects of daily life (the effect on health today was significantly higher than in group 1, significant difference between groups P=0.038).
CONCLUSIONS


FES in the posturally corrected position has an immediate therapeutic effect on balance and patients' perceptions comparable to motor program activating therapy, and higher persistent and even delayed therapeutic effect.
CLINICAL REHABILITATION IMPACT


The study results point to the importance of correcting the patients' posture when applying FES, the possibility to treat foot drop by individual physiotherapy and the activation of the patients' auto reparative processes.",2020,"Group 2 showed an immediate improvement in BBS (p = 0.025), MSIS (p=0.043) and several aspects of daily life (the effect on health today was significantly higher than in Group 1, significant difference between groups p=0.038).
","['people with multiple sclerosis', '44 subjects with Multiple Sclerosis', 'Primary outcomes']","['Functional Electric Stimulation (FES', 'functional electric stimulation', 'motor program activating therapy', 'Functional Electric Stimulation in Posturally Corrected Position (Group 1) and neuroproprioceptive facilitation and inhibition physiotherapy called Motor Program Activating Therapy (Group 2']","['g. Multiple Sclerosis Impact Scale, MSIS; Euroqol-5 dimensions-5 levels, EQ-5D-5L', 'MSIS', 'BBS', '25-Foot Walk test; Multiple Sclerosis Walking Scale-12) and balance (by e.g. Berg Balance Scale, BBS; The Activities-Specific Balance Confidence Scale, ABC; Timed Up and Go Test, TUG', 'health today', ""mobility, cognition, fatigue and subjects' perceptions (e"", 'immediate therapeutic effect in BBS', 'several aspects of daily life', 'EQ-5D-5L', 'gait']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",44.0,0.0319324,"Group 2 showed an immediate improvement in BBS (p = 0.025), MSIS (p=0.043) and several aspects of daily life (the effect on health today was significantly higher than in Group 1, significant difference between groups p=0.038).
","[{'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Prokopiusova', 'Affiliation': 'Department of Rehabilitation, Third Faculty of Medicine, Kralovske Vinohrady University Hospital, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Pavlikova', 'Affiliation': 'Department of Rehabilitation, Third Faculty of Medicine, Kralovske Vinohrady University Hospital, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Markova', 'Affiliation': 'Department of Rehabilitation, Third Faculty of Medicine, Kralovske Vinohrady University Hospital, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Rasova', 'Affiliation': 'Department of Rehabilitation, Third Faculty of Medicine, Kralovske Vinohrady University Hospital, Charles University, Prague, Czech Republic - kamila.rasova@gmail.com.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06104-3']
52,32328148,"Correction to: Efficacy of the interpersonal and social rhythm therapy (IPSRT) in patients with bipolar disorder: results from a real-world, controlled trial.",[This corrects the article DOI: 10.1186/s12991-020-00266-7.].,2020,[This corrects the article DOI: 10.1186/s12991-020-00266-7.].,['patients with bipolar disorder'],['interpersonal and social rhythm therapy (IPSRT'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0275523,[This corrects the article DOI: 10.1186/s12991-020-00266-7.].,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Steardo', 'Affiliation': '1Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Largo Madonna Delle Grazie, 80138 Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Luciano', 'Affiliation': '1Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Largo Madonna Delle Grazie, 80138 Naples, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Sampogna', 'Affiliation': '1Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Largo Madonna Delle Grazie, 80138 Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zinno', 'Affiliation': '1Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Largo Madonna Delle Grazie, 80138 Naples, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Saviano', 'Affiliation': 'UOSM Nola, DSM ASL NA 3 Sud, Nola, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Staltari', 'Affiliation': '2Psychiatric Unit, Department of Health Sciences, University Magna Graecia, Catanzaro, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Segura Garcia', 'Affiliation': '4Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'De Fazio', 'Affiliation': '2Psychiatric Unit, Department of Health Sciences, University Magna Graecia, Catanzaro, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fiorillo', 'Affiliation': '1Department of Psychiatry, University of Campania ""Luigi Vanvitelli"", Largo Madonna Delle Grazie, 80138 Naples, Italy.'}]",Annals of general psychiatry,['10.1186/s12991-020-00278-3']
53,32390143,CORRIGENDUM: Is Placebo Response Responsible for Many Phase III Failures?,,2020,,[],[],[],[],[],[],,0.0327224,,[],Clinical pharmacology and therapeutics,['10.1002/cpt.1730']
54,32393279,Protocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR).,"BACKGROUND


Narcolepsy is a rare chronic sleep disorder that typically begins in youth. Excessive daytime sleepiness is the main disabling symptom, but the disease is often associated with severe endocrine-metabolic and psychosocial issues, worsened by a long diagnostic delay, requiring a multidisciplinary approach. The scarcity of reference Sleep Centres forces the patient and family to travel for seeking medical consultations, increasing the economic and psychosocial burden of the disease. Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders. However, Telemedicine clinical and economic benefits for patients with narcolepsy are still unknown.
METHODS


TENAR is a two-part project, including: 1. a cross-sectional study (involving 250 children and adults with suspected narcolepsy) evaluating the accuracy of Teletriage (i.e., a synchronous live interactive sleep assessment through a Televisit) for narcolepsy diagnosis compared to the reference standard; and 2. a two-arm, parallel, open randomized controlled trial (RCT) to demonstrate the non-inferiority of the multidisciplinary care of narcolepsy through Televisits versus standard care. In this RCT, 202 adolescents (> 14 y.o.) and adults with narcolepsy will be randomly allocated (1:1 ratio) either to Televisits via videoconference or to standard in-person outpatient follow-up visits (control arm). The primary outcome is sleepiness control (according to the Epworth Sleepiness Scale). Secondary outcomes are other symptoms control, compliance with treatment, metabolic control, quality of life, feasibility, patient and family satisfaction with care, safety, and disease-related costs. At baseline and at 12 months, patients will undergo neurologic, metabolic, and psychosocial assessments and we will measure primary and secondary outcomes. Primary outcomes will be also measured at 6 months (remotely or in person, according to the arm).
DISCUSSION


TENAR project will assess, for the first time, the feasibility, accuracy, efficacy and safety of Telemedicine procedures applied to the diagnosis and the multidisciplinary care of children and adults with narcolepsy. The study may be a model for the remote management of other rare disorders, offering care access for patients living in areas lacking medical centres with specific expertise.
TRIAL REGISTRATION


Number of the Tele-multidisciplinary care study NCT04316286. Registered 20 March 2020.",2020,"Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders.","['person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR', '202 adolescents (>\u200914 y.o.) and adults with narcolepsy', 'children and adults with narcolepsy', 'patients with narcolepsy', '250 children and adults with suspected narcolepsy', 'patients living in areas lacking medical centres with specific expertise']","['Televisits via videoconference or to standard in-person outpatient follow-up visits (control arm', 'synchronous live interactive sleep assessment through a Televisit', 'Telemedicine']","['6\u2009months (remotely or in person, according to the arm', 'symptoms control, compliance with treatment, metabolic control, quality of life, feasibility, patient and family satisfaction with care, safety, and disease-related costs', 'sleepiness control (according to the Epworth Sleepiness Scale', 'Excessive daytime sleepiness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}]",250.0,0.120184,"Growing evidence suggests that Telemedicine may facilitate patient access to sleep consultations and its non-inferiority in terms of patient satisfaction, adherence to treatment, and symptom improvement for sleep disorders.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ingravallo', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Vignatelli', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy. l.vignatelli@ausl.bologna.it.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Pagotto', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vandi', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Moresco', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Mangiaruga', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Oriolo', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Zenesini', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pizza', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, Bologna, Italy.'}]",BMC neurology,['10.1186/s12883-020-01762-9']
55,32336645,"Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study.","BACKGROUND


In the ARCHES study in metastatic hormone-sensitive prostate cancer (mHSPC), enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival (rPFS) versus ADT alone.
OBJECTIVE


To evaluate patient-reported outcomes (PROs) to week 73.
DESIGN, SETTING, AND PARTICIPANTS


ARCHES (NCT02677896) was a randomised, double-blind, placebo-controlled, phase 3 study in mHSPC patients.
INTERVENTION


Enzalutamide (160 mg/day) plus ADT or placebo plus ADT.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


PROs were assessed at baseline, week 13, and every 12 wk until disease progression using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate 25 (QLQ-PR25), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Brief Pain Inventory Short Form, and EuroQoL 5-Dimensions, 5-Levels (EQ-5D-5 L) instruments. Endpoints included time to first (TTFD) and first confirmed (TTFCD) clinically meaningful deterioration (using predefined questionnaire thresholds) in health-related quality of life (HRQoL) and pain.
RESULTS AND LIMITATIONS


A total of 1150 patients received ADT plus enzalutamide (n = 574) or placebo (n = 576). Baseline PRO scores indicated high HRQoL and low pain, which was generally maintained in both groups. There were no statistically significant (nominal p > 0.05) between-group differences that occurred in both TTFD and TTFCD together for QLQ-PR25 and FACT-P scores. Enzalutamide significantly delayed TTFD in worst pain (by ∼3 mo; nominal p = 0.032), pain severity (nominal p = 0.021), and EQ-5D-5 L visual analogue scale score (nominal p = 0.0070) versus placebo (not significant for confirmed deterioration for pain outcomes). Enzalutamide delays deterioration in several HRQoL subscales and pain severity in high-volume disease.
CONCLUSIONS


Enzalutamide plus ADT enables men with mHSPC to maintain high-functioning HRQoL and low symptom burden.
PATIENT SUMMARY


This study examined the effect on health-related quality of life and pain of adding enzalutamide or placebo to androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer. Addition of enzalutamide allowed patients to maintain their health-related quality of life.",2020,"Enzalutamide significantly delayed TTFD in worst pain (by ∼3 mo; nominal p = 0.032), pain severity (nominal p = 0.021), and EQ-5D-5 L visual analogue scale score (nominal p = 0.0070) versus placebo (not significant for confirmed deterioration for pain outcomes).","['1150 patients received', 'patients with metastatic hormone-sensitive prostate cancer', 'mHSPC patients', 'Patients with Metastatic Hormone-sensitive Prostate Cancer']","['Enzalutamide (160\u2009mg/day) plus ADT or placebo plus ADT', 'enzalutamide', 'Enzalutamide plus ADT', 'Enzalutamide', 'Enzalutamide plus Androgen Deprivation Therapy', 'Placebo', 'enzalutamide plus androgen deprivation therapy (ADT', 'placebo', 'enzalutamide or placebo to androgen deprivation therapy', 'ADT plus enzalutamide']","['delayed TTFD in worst pain', 'Health-related Quality of Life', 'Cancer Quality of Life Questionnaire-Prostate 25 (QLQ-PR25), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Brief Pain Inventory Short Form, and EuroQoL 5-Dimensions, 5-Levels', 'TTFD and TTFCD together for QLQ-PR25 and FACT-P scores', 'time to first (TTFD) and first confirmed (TTFCD) clinically meaningful deterioration (using predefined questionnaire thresholds) in health-related quality of life (HRQoL) and pain', 'Baseline PRO scores', 'EQ-5D-5\u2009L visual analogue scale score', 'pain severity', 'radiographic progression-free survival (rPFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016865', 'cui_str': 'Fursultiamin'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1150.0,0.528219,"Enzalutamide significantly delayed TTFD in worst pain (by ∼3 mo; nominal p = 0.032), pain severity (nominal p = 0.021), and EQ-5D-5 L visual analogue scale score (nominal p = 0.0070) versus placebo (not significant for confirmed deterioration for pain outcomes).","[{'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, University Hospital, Eberhard Karls University of Tübingen, Tübingen, Germany. Electronic address: arnulf.stenzl@med.uni-tuebingen.de.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dunshee', 'Affiliation': 'Urological Associates of Southern Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'Herzen Moscow Cancer Research Institute, Moscow, Russia.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Department of Urology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Flaig', 'Affiliation': 'Division of Medical Oncology, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Department of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Morlock', 'Affiliation': 'Astellas Pharma Inc., Northbrook, IL, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'IQVIA, Amsterdam-Zuidoost, The Netherlands.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramaswamy', 'Affiliation': 'Global HEOR, Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Duke Cancer Institute Center for Prostate and Urologic Cancer, Durham, NC, USA.'}]",European urology,['10.1016/j.eururo.2020.03.019']
56,32302930,"Attentional prioritization in dual-task walking: Effects of stroke, environment, and instructed focus.","BACKGROUND


The impact of high distraction, real-world environments on dual-task interference and flexibility of attentional prioritization during dual-task walking in people with stroke is unknown.
RESEARCH QUESTION


How does a real-world environment affect dual-task performance and flexible task prioritization during dual-task walking in adults with and without stroke?
METHODS


Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated. Single and dual-task walking were examined in two different environments (lab hallway, hospital lobby). Two different dual-task combinations were assessed (Stroop-gait, speech-gait). Each dual-task was performed first without explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction in randomized order.
RESULTS


People with stroke had significantly slower dual-task gait speed (Stroop only) in the lobby than the lab, but the effect was not clinically meaningful. Stroop reaction time for all participants was also slower in the lobby than the lab. All participants slowed their walking speed while generating spontaneous speech, but this effect was not influenced by environment. The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
SIGNIFICANCE


Although dual-tasking slows walking speed and verbal responses to auditory stimuli in people with stroke, the effects are not considerably impacted by a more complex, distracting environment. Adults with and without stroke may have difficulty overriding the preferred attention allocation strategy during dual-task walking, especially for habitual dual-tasks such as walking while speaking. It may also be that the cognitive control strategy governing task prioritization is influenced by degree of cognitive engagement.",2020,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","['Adults with and without stroke', 'adults with and without stroke', 'Adults with stroke (n = 29) as well as age-, gender-, and education-matched adults without stroke (n = 23) participated', 'people with stroke']",['explicit instruction about task prioritization (no-priority) and then with gait-priority instruction and Stroop/speech-priority instruction'],"['walking speed while generating spontaneous speech', 'Stroop reaction time', 'dual-task gait speed']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",23.0,0.0469792,"The dual-task attention allocation strategy was generally inflexible to instructed prioritization in adults with and without stroke in both environments, however, the volitional attention allocation strategy differed for the two dual-task conditions such that speech was prioritized in the speech-gait dual-task and gait appeared to be prioritized in the Stroop-gait dual-task.
","[{'ForeName': 'Prudence', 'Initials': 'P', 'LastName': 'Plummer', 'Affiliation': 'Department of Physical Therapy, MGH Institute of Health Professions, 36 1st Avenue, Boston, MA, 02129, United States. Electronic address: pplummer@mghihp.edu.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Altmann', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Feld', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, NC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zukowski', 'Affiliation': 'Department of Physical Therapy, High Point University, High Point, NC, United States.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Najafi', 'Affiliation': 'Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Giuliani', 'Affiliation': 'Department of Allied Health Sciences, University of North Carolina at Chapel Hill, NC, United States.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.013']
57,32374283,Effect of a rapid e-learning module and brief interprofessional simulation event on medical and nursing student collaborative attitudes and behaviors.,"Objectives Undergraduate nursing and first-year medical students participated in a brief, scenario-based, interprofessional event. The experimental group only was provided an innovative, rapid e-learning instructional module focused on interprofessional roles/responsibilities and communication prior to the event. Methods Pre-post attitudes toward physician-nurse collaboration were surveyed, and collaborative behaviors were observed during the event. Results For the experimental group, a statistically significant (p<0.05) attitude improvement was found between pre-post e-learning module scores as well as pre-e-learning module and post-simulation event scores. For the control group, a statistically significant (p=0.001) attitude improvement was found between pre-post simulation event scores. No statistically significant differences in team collaborative behaviors were observed between experimental and control. Conclusions The combination of module and simulation event was not a more effective option than the event alone. As both interventions present unique challenges in regards to technology and facility requirements, having multiple effective intervention options will be of benefit to educational institutions.",2020,"Results For the experimental group, a statistically significant (p<0.05) attitude improvement was found between pre-post e-learning module scores as well as pre-e-learning module and post-simulation event scores.","['Objectives Undergraduate nursing and first-year medical students participated in a brief, scenario-based, interprofessional event']",['rapid e-learning module and brief interprofessional simulation'],"['team collaborative behaviors', 'attitude improvement']","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0130626,"Results For the experimental group, a statistically significant (p<0.05) attitude improvement was found between pre-post e-learning module scores as well as pre-e-learning module and post-simulation event scores.","[{'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Visker', 'Affiliation': 'Minnesota State University Mankato, Mankato, MN, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Welker', 'Affiliation': 'Truman State University, Kirksville, MO, USA.'}, {'ForeName': 'Darson', 'Initials': 'D', 'LastName': 'Rhodes', 'Affiliation': 'SUNY Brockport School of Health and Human Performance, Brockport, NY, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Forsyth', 'Affiliation': 'Minnesota State University Mankato, Mankato, MN, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Melvin', 'Affiliation': 'Truman State University, Kirksville, MO, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Truman State University, HES, 2123 Pershing Building - HES, 100 E Normal St, Truman State University, Kirksville, MO, USA.'}]",International journal of nursing education scholarship,['10.1515/ijnes-2019-0122']
58,32381562,Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.,"BACKGROUND


The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA.
METHODS


C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare: ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period.
RESULTS


At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable.
CONCLUSIONS


Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal.
TRIAL REGISTRATION NUMBER


NCT02505542, ClinicalTrials.gov.",2020,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","['ASDAS) <1.3 at Weeks 32/36 and 48', 'patients with early axSpA.\nMETHODS', 'patients with axial spondyloarthritis (axSpA', 'adults with early active axSpA (radiographic or non-radiographic']","['CZP 200\u2009mg every 2 weeks (Q2W', 'CZP 200\u2009mg every 4 weeks (Q4W; reduced maintenance dose) or placebo', 'CZP 200\u2009mg Q2W', 'placebo']","['remaining flare-free (flare: ASDAS', 'sustained remission (Ankylosing Spondylitis Disease Activity Score', 'sustained remission', 'flare-free']","[{'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",,0.666024,"At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo.","[{'ForeName': 'Robert Bm', 'Initials': 'RB', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands landewe@rlandewe.nl.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Depertment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Herne, Germany.'}, {'ForeName': 'Filip E', 'Initials': 'FE', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Gaffney', 'Affiliation': 'Rheumatology Department, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hoepken', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Owen R', 'Initials': 'OR', 'LastName': 'Davies', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'de Peyrecave', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Lianne', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216839']
59,32384122,Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial.,"BACKGROUND


In the primary analysis of a 12-month double-blind randomized active placebo-controlled trial, treatment of children with cystic fibrosis (CF) and pancreatic insufficiency (PI) with a readily absorbable structured lipid (Encala™, Envara Health, Wayne, PA) was safe, well-tolerated and improved dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA).
OBJECTIVE


To determine if the Encala™ treatment effect varied by severity of baseline fat malabsorption.
METHODS


Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala™ or a calorie and macronutrient-matched placebo were included in this subgroup analysis. Subjects were categorized by median baseline CFA: low CFA (<88%) and high CFA (≥88%). At baseline and 3-month evaluations, CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores were calculated. Fasting plasma fatty acid (FA) concentrations were also measured.
RESULTS


Subjects in the low CFA subgroup had significantly improved CFA (+7.5±7.2%, mean 86.3±6.7, p = 0.002), and reduced stool fat loss (-5.7±7.2 g/24 hours) following three months of EncalaTM treatment. These subjects also had increased plasma linoleic acid (+20%), α-linolenic acid (+56%), and total FA (+20%) (p≤0.005 for all) concentrations and improvements in HAZ (0.06±0.08), WAZ (0.17±0.16), and BMIZ (0.20±0.25) (p≤0.002 for all). CFA and FA were unchanged with placebo in the low CFA group, with some WAZ increases (0.14±0.24, p = 0.02). High CFA subjects (both placebo and Encala™ groups) had improvements in WAZ and some FA.
CONCLUSIONS


Subjects with CF, PI and more severe fat malabsorption experienced greater improvements in CFA, FA and growth after three months of Encala™ treatment. Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.",2020,"Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.","['children with cystic fibrosis', 'children with cystic fibrosis (CF) and pancreatic insufficiency (PI', 'Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala™ or a']","['calorie and macronutrient-matched placebo', 'WAZ', 'placebo']","['residual fat malabsorption and growth', 'plasma linoleic acid', 'safe, well-tolerated and efficacious', 'Fasting plasma fatty acid (FA) concentrations', 'CFA', 'total FA', 'CFA and FA', 'CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores', 'concentrations and improvements in HAZ', 'dietary energy absorption, weight gain and FA status', 'stool fat loss', 'dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA', 'CFA, FA and growth', 'α-linolenic acid']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030293', 'cui_str': 'Pancreatic insufficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0554103', 'cui_str': 'Intestinal malabsorption of fat'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0443214', 'cui_str': 'Fat absorption'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}]",,0.119462,"Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Mascarenhas', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Maqbool', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}]",PloS one,['10.1371/journal.pone.0232685']
60,32384147,Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain.,"Altered mitochondrial function occurs in sickle cell disease (SCD), due in part to low nitric oxide (NO) bioavailability. Arginine, the substrate for NO production, becomes acutely deficient in SCD patients with vaso-occlusive pain episodes (VOE). To determine if arginine improves mitochondrial function, 12 children with SCD-VOE (13.6 ± 3 years; 67% male; 75% hemoglobin-SS) were randomized to 1 of 3 arginine doses: (1) 100 mg/kg IV 3 times/day (TID); (2) loading dose (200 mg/kg) then 100 mg/kg TID; or (3) loading dose (200 mg/kg) followed by continuous infusion (300 mg/kg per day) until discharge. Platelet-rich plasma mitochondrial activity, protein expression, and protein-carbonyls were measured from emergency department (ED) presentation vs discharge. All VOE subjects at ED presentation had significantly decreased complex-V activity compared to a steady-state cohort. Notably, complex-V activity was increased at discharge in subjects from all 3 arginine-dosing schemes; greatest increase occurred with a loading dose (P < .001). Although complex-IV and citrate synthase activities were similar in VOE platelets vs steady state, enzyme activities were significantly increased in VOE subjects after arginine-loading dose treatment. Arginine also decreased protein-carbonyl levels across all treatment doses (P < .01), suggesting a decrease in oxidative stress. Arginine therapy increases mitochondrial activity and reduces oxidative stress in children with SCD/VOE. This trial was registered at www.clinicaltrials.gov as #NCT02536170.",2020,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","['Children with Sickle Cell Disease during Vaso-occlusive Pain', 'sickle cell disease (SCD', 'children with SCD/VOE', 'SCD patients with vaso-occlusive-painful-events (VOE', '12 children with SCD hospitalized for VOE (age 13.6±3 years, 67% male, 75% HbSS']","['arginine therapy', 'Arginine therapy', 'arginine', 'Arginine Therapy']","['mitochondrial activity', 'oxidative stress', 'complex-V activity', 'protein-carbonyl levels', 'Platelet-rich-plasma mitochondrial activity, protein expression, and protein-carbonyls', 'Mitochondrial Function', 'VOE platelets vs. steady state, enzyme activities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0069436', 'cui_str': 'oligomycin sensitivity-conferring protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]",12.0,0.0192241,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","[{'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Morris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Lou Ann S', 'Initials': 'LAS', 'LastName': 'Brown', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reynolds', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Dampier', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lane', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Watt', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Kumari', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Shaminy', 'Initials': 'S', 'LastName': 'Manoranjithan', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Reshika D', 'Initials': 'RD', 'LastName': 'Mendis', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Shiva', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}]",Blood,['10.1182/blood.2019003672']
61,32387214,"Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labelled, randomized controlled trial.","AIMS & OBJECTIVES


The hand-sewn method of bowel anastomosis is the most common because of its affordability, familiarity and easy availability of materials. It can be done in single or double layers, with different surgeons preferring one technique over the other. Double layer intestinal anastomosis (DLIA) is time-consuming, challenging to perform, and carries possibly a higher risk of devascularisation, infection, and necrosis. Studies conducted so far do not show a significant difference between the two, but have concluded that more studies are required to determine this definitively. This study attempted to see whether the single layer intestinal anastomosis (SLIA) is non-inferior to DLIA in terms of incidence of anastomotic leak. It also compared mortality, morbidity, and length of hospitalization (LOH) between the two groups.
MATERIALS AND METHODS


This was a parallel arm, open labelled, non-inferiority randomized controlled trial conducted in the department of surgery in a tertiary care centre between October 2016 and March 2018. Patients who fulfilled the inclusion criteria were randomly allotted to two groups: Patients undergoing SLIA and patients undergoing DLIA. After the procedure, all patients were assessed for anastomotic leak, morbidity, mortality and LOH in the postoperative period. A 3-month follow-up period was observed for complications.
RESULTS


A total of 106 patients were randomised, 52 in SLIA and 54 in DLIA. Baseline demographic and clinicopathological characteristics between the two groups were comparable. The most common indication for intestinal anastomosis was ostomy closure in both groups. There was no significant difference between the two groups in terms of anastomotic leak, other complications, mortality and LOH.
CONCLUSION


SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalization, and can be considered as a safe and feasible alternative, in elective and emergency settings.",2020,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","['Patients who fulfilled the inclusion criteria', 'department of surgery in a tertiary care centre between October 2016 and March 2018', '106 patients were randomised, 52 in SLIA and 54 in DLIA']","['single layered intestinal anastomosis', 'single layer intestinal anastomosis (SLIA', 'Double layer intestinal anastomosis (DLIA', 'SLIA and patients undergoing DLIA']","['anastomotic leak, other complications, mortality and LOH.\nCONCLUSION', 'mortality, morbidity, and length of hospitalisation (LOH', 'Baseline demographic and clinicopathological characteristics', 'anastomotic leak, morbidity, mortality, and the length of hospitalisation', 'anastomotic leak, morbidity, mortality and LOH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",106.0,0.173847,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aniruthan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Amuda Ravichandar', 'Initials': 'AR', 'LastName': 'Pranavi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Gubbi Shamanna', 'Initials': 'GS', 'LastName': 'Sreenath', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: dr.sreenathgs@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.066']
62,32330277,Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial.,"Importance


There is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug.
Objective


To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19.
Design, Setting, and Participants


This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon.
Interventions


Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days).
Main Outcomes and Measures


Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4.
Results


Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to high-dosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%).
Conclusions and Relevance


The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir. These findings cannot be extrapolated to patients with nonsevere COVID-19.
Trial Registration


ClinicalTrials.gov Identifier: NCT04323527.",2020,"Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively.","['Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men', '81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon', 'Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group', 'Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2', 'patients with severe COVID-19']","['azithromycin and oseltamivir', 'high-dosage CQ ', 'low-dosage CQ ', 'Chloroquine Diphosphate', 'chloroquine diphosphate (CQ']","['participant clinical status, laboratory examinations, and electrocardiogram results', 'Viral RNA', 'reduction in lethality', 'Respiratory secretion', 'safety and efficacy', 'Viral respiratory secretion RNA detection', 'Infection', 'safety and lethality outcomes', 'instance of QTc interval', 'Lethality']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0055447', 'cui_str': 'Chloroquine phosphate'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1532372', 'cui_str': 'Respiratory secretion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",81.0,0.0816988,"Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and high-dosage groups, respectively.","[{'ForeName': 'Mayla Gabriela Silva', 'Initials': 'MGS', 'LastName': 'Borba', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Fernando Fonseca Almeida', 'Initials': 'FFA', 'LastName': 'Val', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcia Almeida Araújo', 'Initials': 'MAA', 'LastName': 'Alexandre', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Gisely Cardoso', 'Initials': 'GC', 'LastName': 'Melo', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Brito', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Maria Paula Gomes', 'Initials': 'MPG', 'LastName': 'Mourão', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'José Diego', 'Initials': 'JD', 'LastName': 'Brito-Sousa', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Djane', 'Initials': 'D', 'LastName': 'Baía-da-Silva', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinitius Farias', 'Initials': 'MVF', 'LastName': 'Guerra', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Ludhmila Abrahão', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rosemary Costa', 'Initials': 'RC', 'LastName': 'Pinto', 'Affiliation': 'Fundação de Vigilância em Saúde do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Antonio Alcirley Silva', 'Initials': 'AAS', 'LastName': 'Balieiro', 'Affiliation': 'Instituto Leônidas and Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Antônio Guilherme Fonseca', 'Initials': 'AGF', 'LastName': 'Pacheco', 'Affiliation': 'Programa de Computação Científica, Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'James Dean Oliveira', 'Initials': 'JDO', 'LastName': 'Santos', 'Affiliation': 'Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Felipe Gomes', 'Initials': 'FG', 'LastName': 'Naveca', 'Affiliation': 'Instituto Leônidas and Maria Deane, Fiocruz Amazonas, Manaus, Brazil.'}, {'ForeName': 'Mariana Simão', 'Initials': 'MS', 'LastName': 'Xavier', 'Affiliation': 'Instituto Nacional de Infectologia Carlos Chagas-Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'André Machado', 'Initials': 'AM', 'LastName': 'Siqueira', 'Affiliation': 'Instituto Nacional de Infectologia Carlos Chagas-Fiocruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Schwarzbold', 'Affiliation': 'Universidade Federal de Santa Maria, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'Croda', 'Affiliation': 'Faculdade de Medicina da Universidade Federal do Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Maurício Lacerda', 'Initials': 'ML', 'LastName': 'Nogueira', 'Affiliation': 'Faculdade de Medicina de São José do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Gustavo Adolfo Sierra', 'Initials': 'GAS', 'LastName': 'Romero', 'Affiliation': 'Universidade de Brasília, Brasília, Brazil.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cor Jesus', 'Initials': 'CJ', 'LastName': 'Fontes', 'Affiliation': 'Universidade Federal de Mato Grosso, Mato Grosso, Brazil.'}, {'ForeName': 'Bernardino Cláudio', 'Initials': 'BC', 'LastName': 'Albuquerque', 'Affiliation': 'Faculdade de Medicina da Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Cláudio-Tadeu', 'Initials': 'CT', 'LastName': 'Daniel-Ribeiro', 'Affiliation': 'Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.8857']
63,32330764,Preventing college student nonmedical prescription stimulant use: Development of vested interest theory-based persuasive messages.,"Vested interest theory (VIT) predicts that perceived importance and hedonic relevance of an expected behavioral outcome affects attitude-behavior consistency. Applied to college students' nonmedical use of prescription stimulants (NUPS), the theory posits that persuasive information that weakens vested perceptions regarding assumed advantages of stimulant misuse will reduce usage intentions. The current study developed and experimentally assessed persuasive messages that targeted perceptions of vested interest (VI), and examined if message effectiveness varied as a function of users' risk status. Appeals that focused on the physical harms of misuse served as the comparison condition. College student participants (N = 282) were randomly assigned to one of four message conditions. To examine group differences, data were analyzed in a 2 (VIT-based message: yes, no) × 2 (Physical harms emphasized: yes, no) × 3 (User status: resolute, vulnerable, user) between-subjects factorial design. Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005. In vulnerable nonusers, these messages also decreased NUPS intentions p = .006. The effect of exposure to the physical harm communication was not significant. Findings support the potential of VIT-guided messages in NUPS prevention, and the lack of effect of messages focused on physical consequences of misuse.",2020,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"['College student participants (N\xa0=\xa0282', 'college students']","['Vested interest theory (VIT', 'NUPS', 'nonmedical use of prescription stimulants (NUPS']",['cognitive functioning'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517681', 'cui_str': '282'}]","[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",282.0,0.0167375,Analyses showed that messages focused on lowering VI by convincing students that NUPS did not enhance cognitive functioning of non-ADD/ADHD students reduced perceived vested interest (p < .001) and attitude favoribility p = .005.,"[{'ForeName': 'Candice D', 'Initials': 'CD', 'LastName': 'Donaldson', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Candice.Donaldson@cgu.edu.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: Jason.Siegel@cgu.edu.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Crano', 'Affiliation': 'Department of Psychology, Claremont Graduate University, 150 E. 10th St., Claremont, CA 91711, USA. Electronic address: William.Crano@cgu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106440']
64,31226323,Contraceptive method switching among women living in sub-Saharan Africa participating in an HIV-1 prevention trial: a prospective cohort study.,"OBJECTIVE


Long-acting reversible contraceptive (LARC) method uptake has been low within the context of HIV prevention trials. Within a multinational study (MTN-020/ASPIRE), the Contraceptive Action Team improved LARC accessibility and uptake. In this secondary analysis, we determined the rate of contraceptive method continuation among the women enrolled.
STUDY DESIGN


ASPIRE was a randomized, double-blinded, placebo-controlled phase III safety and effectiveness study of the Dapivirine Vaginal Ring for HIV-1 prevention. Between 2012 and 2014, sexually active women aged 18-45 from Malawi, South Africa, Uganda and Zimbabwe were enrolled. All participants were required to use contraception for enrollment to the study and could choose between all highly effective contraceptive methods available in their respective countries. Women were seen monthly and could change methods at any time. Continuation rates from study enrollment to 6 and 12 months were determined.
RESULTS


The overall contraceptive method continuation rate was 77% (1972/2551) at 6 months and 66% (1694/2551) at 12 months. The 6- and 12-month continuation rates were highest for implantable contraceptives (89%, 82%) followed by copper intrauterine device (83%, 77%). Rates of continuation for injectable contraceptives depot medroxyprogesterone acetate (80%, 69%) and norethisterone enanthate (71%, 54%) were higher than for oral contraceptives, which were continued at 47% at 6 months and 35% at 12 months. The continuation rates of all methods did not differ by users with and without previous contraceptive experience.
CONCLUSIONS


LARC methods have the highest rates of continuation at 12 months and should be routinely offered in the context of HIV prevention trials in sub-Saharan Africa.
IMPLICATIONS


Intrauterine devices and contraceptive implant continuation was high at 12 months among women participating in an HIV prevention trial in sub-Saharan Africa and LARCs and should be routinely offered.",2019,"The 6- and 12-month continuation rates were highest for implantable contraceptives (89%, 82%) followed by copper intrauterine device (83%, 77%).","['women living in sub-Saharan Africa participating in an HIV-1 prevention trial', 'Between 2012 and 2014, sexually active women aged 18-45 from Malawi, South Africa, Uganda and Zimbabwe were enrolled']","['injectable contraceptives depot medroxyprogesterone acetate', 'Contraceptive method switching', 'placebo', 'norethisterone enanthate', 'Long-acting reversible contraceptive', 'Dapivirine Vaginal Ring for HIV-1 prevention']","['copper intrauterine device', 'overall contraceptive method continuation rate', 'LARC accessibility and uptake', 'rate of contraceptive method continuation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068981', 'cui_str': 'norethindrone enanthate'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0021901', 'cui_str': 'IUD, Copper Releasing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",,0.427338,"The 6- and 12-month continuation rates were highest for implantable contraceptives (89%, 82%) followed by copper intrauterine device (83%, 77%).","[{'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Chappell', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA; Magee-Womens Research Institute, Pittsburgh, PA. Electronic address: chappellca@upmc.edu.'}, {'ForeName': 'Ishana', 'Initials': 'I', 'LastName': 'Harkoo', 'Affiliation': 'CAPRISA-University of KwaZulu Natal, Durban, SA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Szydlo', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Bunge', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA; Magee-Womens Research Institute, Pittsburgh, PA.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Division of Infectious Diseases, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Clemensia', 'Initials': 'C', 'LastName': 'Nakabiito', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, UG.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mhlanga', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, ZI.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Kamira', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, UG.'}, {'ForeName': 'Jeanna M', 'Initials': 'JM', 'LastName': 'Piper', 'Affiliation': 'Division of AIDS/NIAID/US National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Balkus', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA; Magee-Womens Research Institute, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contraception,['10.1016/j.contraception.2019.06.006']
65,32332930,Genotype-guided warfarin dosing may benefit patients with mechanical aortic valve replacements: randomized controlled study.,"This prospective, single-blind, randomized study was designed to evaluate the effect of genotype-based warfarin dosing compared with standard warfarin dosing in Korean patients with mechanical cardiac valves. Patients were assigned to either the genotype-based dosing group or the standard dosing group using stratified block randomization. The genotype-based dosing equation was adopted from a previous study which included VKORC1 rs9934438, CYP2C9 rs1057910, CYP4F2 rs2108622, and age. Primary outcomes included the percentage of time in the therapeutic range (pTTR): (i) during the first week following initiation of warfarin therapy, (ii) during hospitalization and (iii) until the first outpatient visit. A total of 91 patients were included in the analysis, 42 treated with genotype-based warfarin dosing and 49 treated with standard warfarin dosing. The genotype frequency differences of the three SNPs included in this study (ie, VKORC1, CYP2C9, CYP4F2), between the genotype-based dosing and standard dosing groups were not different. The genotype-based dosing group trended toward higher pTTR when compared with the standard dosing group, although this difference was not statistically significant. In patients with aortic valve replacement, TTR Traditional  and TTR Rosendaal  were significantly higher in the genotype-based dosing group when compared with the standard dosing group during the first week following treatment initiation [ie, 58.5% vs. 38.1% (p = 0.009) and 64.0% vs. 44.6% (p = 0.012), respectively]. Based on the results, the genotype-guided dosing did not offer a significant clinical advantage, but a possible benefit in patients with aortic valve replacement has been suggested.",2020,"The genotype-based dosing group trended toward higher pTTR when compared with the standard dosing group, although this difference was not statistically significant.","['A total of 91 patients were included in the analysis, 42 treated with genotype-based warfarin dosing and 49 treated with standard warfarin dosing', 'patients with aortic valve replacement', 'patients with mechanical aortic valve replacements', 'Korean patients with mechanical cardiac valves']","['Genotype-guided warfarin', 'genotype-based warfarin', 'standard warfarin']","['TTR Traditional  and TTR Rosendaal', 'percentage of time in the therapeutic range (pTTR): (i) during the first week following initiation of warfarin therapy, (ii) during hospitalization and (iii) until the first outpatient visit']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0182440', 'cui_str': 'Artificial cardiac valve prosthesis'}]","[{'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4303340', 'cui_str': 'Warfarin therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]",91.0,0.0324501,"The genotype-based dosing group trended toward higher pTTR when compared with the standard dosing group, although this difference was not statistically significant.","[{'ForeName': 'Kyung Eun', 'Initials': 'KE', 'LastName': 'Lee', 'Affiliation': 'College of Pharmacy, Chungbuk National University, 660-1, Yeonje-ri, Osong-eup, Heungdeok-gu, Cheongju-si, 28160, Korea.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Yee', 'Affiliation': 'College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul, 03760, Korea.'}, {'ForeName': 'Gwan Yung', 'Initials': 'GY', 'LastName': 'Lee', 'Affiliation': 'College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul, 03760, Korea.'}, {'ForeName': 'Jee Eun', 'Initials': 'JE', 'LastName': 'Chung', 'Affiliation': 'College of Pharmacy, Hanyang University, 55 Hanyangdeahak-ro, Sangnok-gu, Ansan, 15588, Korea.'}, {'ForeName': 'Jong Mi', 'Initials': 'JM', 'LastName': 'Seong', 'Affiliation': 'College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul, 03760, Korea.'}, {'ForeName': 'Byung Chul', 'Initials': 'BC', 'LastName': 'Chang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Bundang CHA Medical Center, CHA University, 59, Yatap-ro, Bundang-gu, Seongnam, 13496, Korea. bcchang@cha.ac.kr.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Gwak', 'Affiliation': 'College of Pharmacy and Graduate School of Pharmaceutical Sciences, Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul, 03760, Korea. hsgwak@ewha.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-63985-7']
66,32383701,[CLINICAL DIAGNOSTIC VALUE OF OXIDATIVE STRESS MARKERS IN PATIENTS WITH CHRONIC HEART FAILURE. OPPORTUNITIES OF THEIR PHARMACOLOGICAL CORRECTION BY ETOXIDOL].,"Purpose - to evaluate the effectiveness of a fundamentally new antioxidant drug Amoxidal malate in patients with chronic heart failure (CHF) and its effect on marker of oxidative stress 2,3-diphosphoglycerate -2,3-DPG regulating the dissociation of oxyhemoglobin into hemoglobin and oxygen depending on the partial pressure of oxygen in the lungs and effect on other markers of oxidative stress. Clinical study of etoxazole was conducted in the city hospital N 23. 32 people were examined. At the age of 55 to 76 years (men and women) with coronary heart disease, stable angina, who had a myocardial infarction with a diagnosis of chronic heart failure II-IU FC according to the NYHA classification. Hypertension was diagnosed in 15 patients and type 2 diabetes mellitus in 8 patients. The study included patients with an ejection fraction of less than 40%. Permanent atrial fibrillation was diagnosed in 6 patients. Patients were divided into 2 groups: 1 main group, 22 patients who were added to the standard therapy with intravenous infusions of Ethylmethylhydroxypyridine malate, 2 group - control group, 10 people who received standard pharmacotherapy of CHF. Indicators of oxidative status, especially 2,3-DPH, were evaluated. and also, the voltage of oxygen (pO2), pCO2, pH, concentration of superoxide dismutase (SOD), malondialdehyde (MDA), the concentration of total peroxides in the blood of these patients. Etilmetilgidroksipiridinamaalat restores oxygenation of the blood in patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK. Analysis comparative assessment of treatment results shows that the addition of Ethoxide to standard therapy is most beneficial effect on patients› IU F. K. the Inclusion of the new Patriotic antioxidant drug Amoxidal in standard therapy of patients with CHF is pathogenetically justified and promising.",2020,Etilmetilgidroksipiridinamaalat restores oxygenation of the blood in patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK.,"['city hospital N 23', 'patients with an ejection fraction of less than 40', '15 patients and type 2 diabetes mellitus in 8 patients', 'patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK', '32 people', 'At the age of 55 to 76 years (men and women) with coronary heart disease, stable angina, who had a myocardial infarction with a diagnosis of chronic heart failure II-IU FC according to the NYHA classification', 'patients with chronic heart failure (CHF']","['standard therapy with intravenous infusions of Ethylmethylhydroxypyridine malate, 2 group - control group, 10 people who received standard pharmacotherapy of CHF', 'etoxazole', 'fundamentally new antioxidant drug Amoxidal malate']","['Etilmetilgidroksipiridinamaalat restores oxygenation', 'Hypertension', 'voltage of oxygen (pO2), pCO2, pH, concentration of superoxide dismutase (SOD), malondialdehyde (MDA), the concentration of total peroxides', 'Permanent atrial fibrillation']","[{'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0024546', 'cui_str': 'Malates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1702038', 'cui_str': 'etoxazole'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0201931', 'cui_str': 'Carbon dioxide measurement, partial pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation'}]",32.0,0.0236632,Etilmetilgidroksipiridinamaalat restores oxygenation of the blood in patients who are intravenously introduced Amoxidal compared with patients not receiving this treatment with CHF IV FK.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pavlova', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kukes', 'Affiliation': '1First Moscow State Medical University named after Sechenov; 2Scientific Center for Expert Evaluation of Medical Products. Moscow, Russia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shih', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Badridinova', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Berechikidze', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Degtyarevskaya', 'Affiliation': '1First Moscow State Medical University named after Sechenov, Russia.'}]",Georgian medical news,[]
67,32387690,Vein conduits used to enhance arterial microsurgical end-to-end suture repair: A randomized comparative study.,"Wrapping microsurgical sutures with a vein conduit is a well-described procedure for microsurgical nerve repair. While this has rarely been described in the context of vascular repair, this technique could increase the permeability of the sutured vessels. As part of a University Diploma in Microsurgery, 9 junior surgeons performed a comparative study of 18 microsurgical repairs on rats with and without vein sleeve. The vessels used were an external jugular vein sleeve on the end-to-end anastomosis of the common carotid artery and comparing it to this same anastomosis without a sleeve. The data analyzed were rat weight, suture time with carotid clamping time, number of stitches used, complications as well as vascular leakage and permeability of the repair at 0 and 5minutes evaluated with a patency test. The average rat body weight was 255g. Mean suture time was 52minutes in group A (sleeved repairs) and 41minutes in group B (standard repairs). The number of stitches placed was 5.1 points on average in group A and 5.6 points in group B. The time to perform the repair and the number of stitches was not statistically different between groups. The patency test was positive in 100% of cases in group A and in 78% of cases in group B. There was a significant difference between the permeability rate of the repairs, with better results in group A (p=0.03). There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01). The addition of a vein sleeve around an end-to-end arterial suture repair seems to improve its permeability and therefore its reliability.",2020,"There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01).",[],"['18 microsurgical repairs on rats with and without vein sleeve', 'Vein conduits used to enhance arterial microsurgical end-to-end suture repair', 'external jugular vein sleeve', 'Wrapping microsurgical sutures with a vein conduit']","['average rat body weight', 'rat weight, suture time with carotid clamping time, number of stitches used, complications as well as vascular leakage and permeability of the repair at 0 and 5 minutes evaluated with a patency test', 'permeability rate', 'number of stitches placed', 'patency test', 'time to perform the repair and the number of stitches', 'Mean suture time', 'anastomotic leaks']",[],"[{'cui': 'C0567345', 'cui_str': 'Microsurgical repair'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0226543', 'cui_str': 'Structure of external jugular vein'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}]",,0.0395513,"There were two anastomotic leaks after declamping in the sleeve group and five in the standard suture group, thus 2.5 times more leaks in the group without a sleeve (p<0.01).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lancien', 'Affiliation': 'Department of Plastic, Reconstructive Surgery, Burns Centre, University Hospital Nantes, 1, place Alexis-Ricordeau, 44000 Nantes, France. Electronic address: ulancien@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Delaveau', 'Affiliation': 'Department of Orthopedic and Traumatology surgery, University Hospital Poitiers, 2, rue de la Milétrie, 86021 Poitiers, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pouedras', 'Affiliation': 'Department of Orthopedic and Traumatology surgery, University Hospital Nantes, 1, place Alexis-Ricordeau, 44000 Nantes, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fortier', 'Affiliation': 'Department of Urology, University Hospital Angers, 4, rue Larrey, 49100 Angers, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bin', 'Affiliation': 'Department of Orthopedic pediatric surgery, Angers University Hospital, 4, rue Larrey, 49100 Angers, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ghersallah', 'Affiliation': 'Department of Stomatology and Maxillofacial Surgery, Hospital of Le Mans, 194, avenue Rubillard, 72037 Le Mans, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jeudy', 'Affiliation': 'Centre de la Main\xa0-\xa0Angers assistance-main, 47, rue de la Foucaudière, 49000 Trélazé, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saint-Cast', 'Affiliation': 'Centre de la Main\xa0-\xa0Angers assistance-main, 47, rue de la Foucaudière, 49000 Trélazé, France.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Fournier', 'Affiliation': 'Department of Neurosurgery, Laboratory of Anatomy, rue Haute de Reculée, 49000 Angers, France.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.04.009']
68,30957141,Half of Purposeful Baseline Sandbaggers Undetected by ImPACT's Embedded Invalidity Indicators.,"OBJECTIVE


The main objectives of this study were to determine how accurately the embedded invalidity indicators (EIIs) identify purposeful underperformers on the baseline Immediate Post-concussion Assessment and Cognitive Test (ImPACT); and to assess the effectiveness of each individual EII.
METHODS


A randomized controlled trial was conducted in which all participants completed a baseline ImPACT assessment. Participants were randomized into a control or purposeful underperformance (sandbagging) group. The primary outcomes measured were the number of participants identified as invalid (via any EII), as well as the ability of each individual EII to detect purposeful sandbagging. Additionally, participants mean raw composite scores and percentiles were evaluated.
RESULTS


Seventy-seven participants completed the study (control n = 37, sandbag n = 40.) None of the participants in the control group, and 50% of the purposeful sandbaggers were identified as invalid via the current EIIs. Of the five EIIs, three were unable to identify more than 15% of purposeful sandbaggers. The best performing EIIs were Word Memory and Three Letters, identifying 40% and 35% of purposeful sandbaggers, respectively. Sixty- five percent of the purposeful sandbaggers had at least one composite score ≤1st percentile. Using a composite score ≤1st percentile as potential marker of invalidity would have accurately identified more purposeful sandbaggers than all existing EIIs combined.
CONCLUSION


Half of purposeful sandbaggers were not identified by ImPACT's current EIIs. Multiple EIIs were only able to identify <15% of purposeful underperformers, suggesting that reevaluation and/or recalibration of EII cutoffs may be appropriate.",2020,"None of the participants in the control group, and 50% of the purposeful sandbaggers were identified as invalid via the current EIIs.","['Seventy-seven participants completed the study (control n = 37, sandbag n = 40']",['control or purposeful underperformance (sandbagging) group'],"['baseline Immediate Post-concussion Assessment and Cognitive Test (ImPACT', 'number of participants identified as invalid (via any EII), as well as the ability of each individual EII to detect purposeful sandbagging']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0231173', 'cui_str': 'Invalidism (finding)'}, {'cui': 'C0070846', 'cui_str': 'EIItMan'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]",77.0,0.0828423,"None of the participants in the control group, and 50% of the purposeful sandbaggers were identified as invalid via the current EIIs.","[{'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Raab', 'Affiliation': 'Butler University, Department of Health Sciences, Indianapolis, IN 46208, USA.'}, {'ForeName': 'Amy Sutton', 'Initials': 'AS', 'LastName': 'Peak', 'Affiliation': 'Butler University, Department of Health Sciences, Indianapolis, IN 46208, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Knoderer', 'Affiliation': 'Butler University, Department of Health Sciences, Indianapolis, IN 46208, USA.'}]",Archives of clinical neuropsychology : the official journal of the National Academy of Neuropsychologists,['10.1093/arclin/acz001']
69,32369630,In situ decompression vs conservative treatment for mild ulnar neuropathy at the elbow.,"INTRODUCTION


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


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


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


In situ decompression for mild UNE may result in faster relief of symptoms when compared with conservative treatment, but at long-term follow-up no differences were observed.",2020,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","['Patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis were recruited', '117 patients were included: 56 and 61 patients']","['situ decompression or conservative treatment', 'situ decompression versus conservative treatment']","['relief of symptoms', 'proportion of patients with subjective symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.0474031,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","[{'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Pompe', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Tobien', 'Initials': 'T', 'LastName': 'Schreuder', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Laurien L', 'Initials': 'LL', 'LastName': 'Teunissen', 'Affiliation': 'Department of Neurology, St. Antonius Ziekenhuis Nieuwegein, The Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beekman', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26912']
70,32380977,"Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial.","BACKGROUND


Multiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been re-organized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS.
METHODS


A pilot clinical trial using 140 mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change.
RESULTS


Forty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was - 0.679% for the AP group and - 1.069% for the placebo group (mean difference: -0.39; 95% CI [- 0.836-0.055], p = 0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200-1.777], p = 0.06). The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (mean difference: 0.63, p = 0.042). Adverse events related to AP were mild rash and dysgeusia.
CONCLUSIONS


AP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02273635 retrospectively registered on October 24th, 2014.",2020,The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (,"['Forty-four patients were randomized: 23', 'not active progressive multiple sclerosis', 'patients with not active primary or secondary progressive MS was conducted']","['140\u2009mg oral AP or placebo', 'andrographolide (AP', 'Andrographolide', 'andrographolide', 'placebo']","['3-month confirmed disability progression (3-CDP) and mean EDSS change', 'mean percentage brain volume change (mPBVC', '3-CDP', 'brain atrophy and disability progression', 'efficacy and safety', 'mild rash and dysgeusia', 'median baseline EDSS', 'Annualized mPBVC', 'mean EDSS change']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0051821', 'cui_str': 'andrographolide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",44.0,0.386963,The mean EDSS change was - 0.025 in the AP group and + 0.352 in the placebo group (,"[{'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Ciampi', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile. ethelciampi@gmail.com.'}, {'ForeName': 'Reinaldo', 'Initials': 'R', 'LastName': 'Uribe-San-Martin', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cárcamo', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile. ccarcamo@med.puc.cl.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Cruz', 'Affiliation': 'Radiology, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Reyes', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Pinto', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Vásquez', 'Affiliation': 'Neurology Department, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay, 362, 5° floor, Santiago, Chile.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Burgos', 'Affiliation': 'Pharmacology and Morphophysiology, Faculty of Veterinary Sciences, Universidad Austral de Chile, Independencia, 613, Valdivia, Chile.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Hancke', 'Affiliation': 'Pharmacology and Morphophysiology, Faculty of Veterinary Sciences, Universidad Austral de Chile, Independencia, 613, Valdivia, Chile.'}]",BMC neurology,['10.1186/s12883-020-01745-w']
71,32381013,Assessing the Veterans Health Administration's response to intimate partner violence among women: protocol for a randomized hybrid type 2 implementation-effectiveness trial.,"BACKGROUND


Intimate partner violence (IPV) against women in the United States (US) remains a complex public health crisis. Women who experience IPV are among the most vulnerable patients seen in primary care. Screening increases the detection of IPV and, when paired with appropriate response interventions, can mitigate the health effects of IPV. The Department of Veterans Affairs (VA) has encouraged evidence-based IPV screening programs since 2014, yet adoption is modest and questions remain regarding the optimal ways to implement these practices, which are not yet available within the majority of VA primary care clinics.
METHODS/DESIGN


This paper describes the planned evaluation of VA's nationwide implementation of IPV screening programs in primary care clinics through a randomized implementation-effectiveness hybrid type 2 trial. With the support of our VA operational partners, we propose a stepped wedge design to compare the impact of two implementation strategies of differing intensities (toolkit + implementation as usual vs. toolkit + implementation facilitation) and investigate the clinical effectiveness of IPV screening programs. Using balanced randomization, 16-20 VA Medical Centers will be assigned to receive implementation facilitation in one of three waves, with implementation support lasting 6 months. Implementation facilitation in this effort consists of the coordinated efforts of the two types of facilitators, external and internal. Implementation facilitation is compared to dissemination of a toolkit plus implementation as usual. We propose a mixed methods approach to collect quantitative (clinical records data) and qualitative (key informant interviews) implementation outcomes, as well as quantitative (clinical records data) clinical effectiveness outcomes. We will supplement these data collection methods with provider surveys to assess discrete implementation strategies used before, during, and following implementation facilitation. The integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide the qualitative data collection and analysis. Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.
DISCUSSION


This research will advance national VHA efforts by identifying the practices and strategies useful for enhancing the implementation of IPV screening programs, thereby ultimately improving services for and health of women seen in primary care.
TRIAL REGISTRATION


NCT04106193. Registered on 23 September 2019.",2020,"This research will advance national VHA efforts by identifying the practices and strategies useful for enhancing the implementation of IPV screening programs, thereby ultimately improving services for and health of women seen in primary care.
","['Health Services', 'primary care clinics', 'Intimate partner violence (IPV) against women in the United States (US) remains a complex public health crisis', ""Veterans Health Administration's response to intimate partner violence among women""]",['IPV screening programs'],['detection of IPV'],"[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",,0.0919335,"This research will advance national VHA efforts by identifying the practices and strategies useful for enhancing the implementation of IPV screening programs, thereby ultimately improving services for and health of women seen in primary care.
","[{'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Iverson', 'Affiliation': ""Women's Health Sciences Division, National Center for PTSD, VA Boston Healthcare System, 150\u2009South Huntington Ave (116B-3), Boston, MA, 02130, USA. Katherine.Iverson@va.gov.""}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Dichter', 'Affiliation': 'VA Center for Health Equity Research and Promotion (CHERP), Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, 19104, PA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Stolzmann', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}, {'ForeName': 'Omonyêlé L', 'Initials': 'OL', 'LastName': 'Adjognon', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lew', 'Affiliation': 'Massachusetts Veterans Epidemiology Research and Information Center, VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}, {'ForeName': 'LeAnn E', 'Initials': 'LE', 'LastName': 'Bruce', 'Affiliation': 'Intimate Partner Violence Assistance Program, Care Management and Social Work, Department of Veterans Affairs, 810 Vermont Avenue, Washington, DC, 20420, USA.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Gerber', 'Affiliation': ""Women's Health Center, VA Boston Healthcare System, 150\u2009S. Huntington Ave, Boston, MA, 02130, USA.""}, {'ForeName': 'Galina A', 'Initials': 'GA', 'LastName': 'Portnoy', 'Affiliation': 'Pain, Research, Informatics, Medical comorbidities, and Education (PRIME) Center, VA Conneticut Healthcare System, 950 Campbell Avenue, West Haven, CT, 06516, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Miller', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, 150\u2009S. Huntington Ave (152\u2009M), Boston, MA, 02130, USA.'}]",Implementation science : IS,['10.1186/s13012-020-0969-0']
72,32384291,"Ketamine and Magnesium for Refractory Neuropathic Pain: A Randomized, Double-blind, Crossover Trial.","BACKGROUND


Ketamine is often used for the management of refractory chronic pain. There is, however, a paucity of trials exploring its analgesic effect several weeks after intravenous administration or in association with magnesium. The authors hypothesized that ketamine in neuropathic pain may provide pain relief and cognitive-emotional benefit versus placebo and that a combination with magnesium may have an additive effect for 5 weeks.
METHODS


A randomized, double-blind, crossover, placebo-controlled study (NCT02467517) included 20 patients with neuropathic pain. Each ketamine-naïve patient received one infusion every 35 days in a random order: ketamine (0.5 mg/kg)/placebo or ketamine (0.5 mg/kg)/magnesium sulfate (3g) or placebo/placebo.The primary endpoint was the area under the curve of daily pain intensity for a period of 35 days after infusion. Secondary endpoints included pain (at 7, 15, 21 and 28 days) and health-related, emotional, sleep, and quality of life questionnaires.
RESULTS


Daily pain intensity was not significantly different between the three groups (n = 20) over 35 days (mean area under the curve = 185 ± 100, 196 ± 92, and 187 ± 90 pain score-days for ketamine, ketamine/magnesium, and placebo, respectively, P = 0.296). The effect size of the main endpoint was -0.2 (95% CI [-0.6 to 0.3]; P = 0.425) for ketamine versus placebo, 0.2 (95% CI [-0.3 to 0.6]; P = 0.445) for placebo versus ketamine/magnesium and -0.4 (95% CI [-0.8 to 0.1]; P = 0.119) for ketamine versus ketamine/magnesium. There were no significant differences in emotional, sleep, and quality of life measures. During placebo, ketamine, and ketamine/magnesium infusions, 10%, 20%, and 35% of patients respectively reported at least one adverse event.
CONCLUSIONS


The results of this trial in neuropathic pain refuted the hypothesis that ketamine provided pain relief at 5 weeks and cognitive-emotional benefit versus placebo and that a combination with magnesium had any additional analgesic effect.",2020,"There were no significant differences in emotional, sleep, and quality of life measures.","['20 patients with neuropathic pain', 'Refractory Neuropathic Pain', '20 patients with chronic neuropathic painNo effect of either the']","['placebo, ketamine, and ketamine/magnesium', 'ketamine or ketamine + magnesium', 'ketamine (0.5 mg/kg)/placebo or ketamine (0.5 mg/kg)/magnesium sulfate (3g) or placebo/placebo', 'ketamine', 'Ketamine', 'Ketamine and Magnesium', 'ketamine, ketamine/magnesium', 'ketamine/magnesium', 'saline, ketamine, and ketamine + magnesium infusions', 'magnesium', 'placebo']","['pain (at 7, 15, 21 and 28 days) and health-related, emotional, sleep, and quality of life questionnaires', 'pain relief', 'area under the curve of daily pain intensity', 'emotional, sleep, and quality of life measures', 'Daily pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.768198,"There were no significant differences in emotional, sleep, and quality of life measures.","[{'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'From University Hospital Clermont-Ferrand, Inserm CIC 1405, Clinical Pharmacology Department, F-63000 Clermont-Ferrand, France (G.P., V.M., A.C., F.G.) Clermont Auvergne University, Inserm 1107, F-63000 Clermont-Ferrand, France (G.P.) University Hospital Clermont-Ferrand, Clinical Research and Innovation Department, F-63000 Clermont-Ferrand, France (B.P., C.L.) University Hospital of Clermont-Ferrand, Assessment and Treatment of Pain Center, F-63000 Clermont-Ferrand, France (F.M., A.B.-B., E.C., N.D.) University Hospital Clermont-Ferrand, Clinical Research/Temporary Authorization Department, F-63000 Clermont-Ferrand, France (L.B.).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Morel', 'Affiliation': ''}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Corriger', 'Affiliation': ''}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Giron', 'Affiliation': ''}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Marcaillou', 'Affiliation': ''}, {'ForeName': 'Assiya', 'Initials': 'A', 'LastName': 'Bidar-Beauvallot', 'Affiliation': ''}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Chandeze', 'Affiliation': ''}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': ''}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': ''}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Delage', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003345']
73,32386466,Group-based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial.,"INTRODUCTION


Chronic pelvic pain in women is a complex condition, and physical therapy is recommended as part of a broader treatment approach. The objective of this study was to compare structured group-based multimodal physical therapy in a hospital setting (intervention group) with primary-care physical therapy (comparator group) for women with chronic pelvic pain.
MATERIAL AND METHODS


Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible. The primary outcome measure was change in the mean pelvic pain intensity from baseline to 12 months, measured using the numeric rating scale (0-10). Secondary outcomes were changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation. The differences between the groups regarding change in scores were analyzed using the independent t test and Mann-Whitney U test. Sensitivity analysis of the primary outcome was performed with a linear regression model adjusted for the baseline value. A P value <.05 was considered statistically significant.
RESULTS


Of the 62 women included, 26 in the intervention group and 25 in the comparator group were available after 12 months for data collection and analysis. The difference between the groups for change in the mean pain intensity score was -1.2 (95% CI -2.3 to -0.2; P = .027), favoring the intervention group. The intervention group showed greater improvements in respiratory patterns (mean difference 0.9; 95% CI 0.2-1.6; P = .015) and pain-related fear of movements (mean difference 2.9; 95% CI -5.5 to -0.3; P = .032), and no significant differences were observed between the groups for the other secondary outcomes.
CONCLUSIONS


Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary-care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.",2020,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","['women with chronic pelvic pain', 'Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible']","['multimodal physical therapy', 'primary care physical therapy (comparator group', 'structured group-based multimodal physical therapy']","['mean pain intensity score', 'respiratory patterns', 'pain-related fear of movements', 'numeric rating scale', 'changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation', 'mean pelvic pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.107811,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","[{'ForeName': 'Ane Sigrid', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona Birgitte', 'Initials': 'MB', 'LastName': 'Rydningen', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Wojniusz', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Marthe', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Clinical Research Department, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Rolv-Ole', 'Initials': 'RO', 'LastName': 'Lindsetmo', 'Affiliation': 'Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro Killi', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13896']
74,32389532,"The Strong Hearts, Healthy Communities Program 2.0: An RCT Examining Effects on Simple 7.","INTRODUCTION


Rural women have higher rates of cardiovascular disease than their nonrural counterparts, partially because of their social and environmental contexts. The study objective is to test a refined version of the multilevel Strong Hearts, Healthy Communities intervention, which used extensive process and outcome evaluation data from the original randomized trial to optimize effectiveness as measured by improved Simple 7 score, a composite measure of cardiovascular disease risk.
STUDY DESIGN


The intervention was implemented in a 6-month, delayed intervention, community-randomized trial; control participants received the program following 24-week outcome assessment. The study was conducted in 2017-2018; data analysis occurred in 2018-2019.
SETTING/PARTICIPANTS


The study was conducted in 11 rural, medically underserved towns in New York. Participants were women aged ≥40 years who were either (1) obese or (2) overweight and sedentary.
INTERVENTION


The intervention group received 24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments.
MAIN OUTCOME MEASURES


Measures included weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors. Individual Simple 7 components were examined, and mixed linear regression analyses were used to examine change in Simple 7 score.
RESULTS


A total of 182 participants were randomized. Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI).
CONCLUSIONS


These findings highlight the importance of rigorously evaluating programs in real-world community settings and, when appropriate, revising and retesting interventions to optimize dissemination potential.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT03059472.",2020,"Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI).
","['2017-2018; data analysis occurred in 2018-2019', '11 rural, medically underserved towns in New York', 'Rural women', '182 participants were randomized', 'Participants were women aged ≥40 years who were either (1) obese or (2) overweight and sedentary']","['24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments']","['Simple 7 components (physical activity, healthy diet score, and BMI', 'weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",182.0,0.0779213,"Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI).
","[{'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University System, College Station, Texas; Department of Nutrition, Texas A&M University, College Station, Texas. Electronic address: r.seguin-fowler@ag.tamu.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': 'Center for Rural Community Health, Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York.'}, {'ForeName': 'Galen D', 'Initials': 'GD', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University System, College Station, Texas.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Marshall', 'Affiliation': 'Master of Public Health Program, Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, New York.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pullyblank', 'Affiliation': 'Center for Rural Community Health, Bassett Research Institute, Cooperstown, New York.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': 'Friedman School of Nutrition, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'Montana State University Extension, Bozeman, Montana.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.01.027']
75,32393193,Neuroprotective effects of exercise in people with progressive multiple sclerosis (Exercise PRO-MS): study protocol of a phase II trial.,"BACKGROUND


Neurodegeneration, rather than inflammation, plays a key role in the progressive phase of multiple sclerosis (MS). Current disease modifying treatment options for people with progressive MS (PMS) do not specifically target neurodegeneration. Preliminary evidence suggests that exercise therapy might have neuroprotective effects. However, neuroprotective effect studies of exercise interventions in PMS are scarce and the possible mode of action underlying neuroprotective effects of exercise are unknown and need to be elucidated. The main aim of this phase II trial is to assess whether progressive resistance training (PRT) and high intensity interval training (HIIT), can slow down neurodegeneration in people with PMS.
METHODS


In a single-blinded phase II clinical trial with an extended baseline period, 60 people with PMS will be randomly assigned to PRT or HIIT. The participants should have had a relapse onset of MS with confirmed disease progression, however still ambulatory. The duration of the study is 48 weeks, consisting of 16 weeks baseline period (no intervention), 16 weeks intervention and 16 weeks follow-up. Patient-tailored training will be performed 3 times per week for one hour in groups, led by an experienced physiotherapist. The primary outcome measure is neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI). Secondary outcome parameters will include other biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors.
DISCUSSION


Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention. Combining outcome parameters may help to elucidate the mode of action underlying neuroprotective effects of exercise.
TRIAL REGISTRATION


This trial is prospectively registered at the Dutch Trial Registry (number NL8265, date 06-01-2020).",2020,"Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention.","['people with PMS', '60 people with PMS', 'people with progressive multiple sclerosis (Exercise PRO-MS', 'people with progressive MS (PMS']","['exercise therapy', 'progressive resistance training (PRT) and high intensity interval training (HIIT', 'exercise']","['neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI', 'biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027746', 'cui_str': 'Nerve degeneration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",60.0,0.173043,"Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention.","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Gravesteijn', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands. a.gravesteijn@amsterdamumc.nl.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Beckerman', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'de Jong', 'Affiliation': 'Department of Neurology, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hulst', 'Affiliation': 'Department of Anatomy and Neurosciences, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'de Groot', 'Affiliation': 'Department of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, PO Box 7057, 1007, MB, Amsterdam, the Netherlands.'}]",BMC neurology,['10.1186/s12883-020-01765-6']
76,32394890,Effects of exercise training on sleep quality and heart rate variability in middle-aged and older adults with poor sleep quality: a randomized controlled trial.,"STUDY OBJECTIVES


We aimed (1) to investigate the effect of a 12-week exercise training on sleep quality and heart rate variability in middle-aged and older adults with poor sleep quality and (2) to examine the factors associated with the improvements in sleep quality and heart rate variability parameters.
METHODS


Forty adults aged ≥ 40 years with poor sleep quality (mean age = 62 years; 82.5% female) participated in this study. They were randomized into the exercise group or control group. Each exercise training program consisted of 40 minutes of supervised aerobic exercise training and 10 minutes of stretching class, 3 times a week for 12 weeks. Outcome measures included both subjective (Pittsburgh Sleep Quality Index) and objective (actigraphy recordings) sleep quality assessments, a cardiopulmonary exercise test, and heart rate variability assessment.
RESULTS


The exercise group showed significant improvements in the global score (P = .003), on all subscales of Pittsburgh Sleep Quality Index (P < .05), and in some heart rate variability parameters compared to the control group. Multiple regression analysis indicated that exercise participation was associated with either the sleep quality (β = -0.617, R² = .407; F = 6.226, P < .001) or heart rate monitor high frequency normalized units (β = 0.503, R² = .225; F = 3.200, P = .003) after adjustment for basic characteristics. However, the statistical significance between exercise participation and heart rate monitor high frequency normalized units diminished after controlling for the Pittsburgh Sleep Quality Index.
CONCLUSIONS


Our results indicated that moderate-intensity exercise training had a beneficial effect on sleep quality and cardiac autonomic function. Middle-aged and older adults with poor sleep quality should be encouraged to engage in a moderate-intensity aerobic exercise training to improve their sleep quality and cardiac autonomic function.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up; URL: https://clinicaltrials.gov/ct2/show/NCT03005990; Identifier: NCT03005990.",2020,"The exercise group showed significant improvements in the global score (p = 0.003), all subscales of PSQI (p < 0.05), and some HRV parameters compared to the control group.","['Forty adults aged ≥ 40 years with poor sleep quality (mean age = 62 years; 82.5% female', 'middle-aged and older adults with poor sleep quality', 'middle-aged and older adults with poor sleep quality and (2', 'Middle-aged and older adults with poor sleep quality']","['exercise training', 'exercise group or control group', 'exercise training program consisted of 40 min of supervised aerobic exercise training', 'moderate intensity aerobic exercise training', 'moderate-intensity exercise training']","['sleep quality and HRV parameters', 'sleep quality and cardiac autonomic function', 'sleep quality and heart rate variability (HRV', 'HRV parameters', 'subjective (Pittsburgh sleep quality index, PSQI) and objective (actigraphy recordings) sleep quality assessments, cardiopulmonary exercise test, and HRV assessment', 'global score', 'sleep quality', 'subscales of PSQI', 'sleep quality and heart rate variability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0236019,"The exercise group showed significant improvements in the global score (p = 0.003), all subscales of PSQI (p < 0.05), and some HRV parameters compared to the control group.","[{'ForeName': 'Tseng-Hau', 'Initials': 'TH', 'LastName': 'Tseng', 'Affiliation': 'Department of Rehabilitation, China Medical University Hospital, Taiwan.'}, {'ForeName': 'Hsi-Chung', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry and Center of Sleep Disorders, National Taiwan University and Hospital, Taiwan.'}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': 'School and Graduate Institute of Physical Therapy and Physical Therapy Center, National Taiwan University and Hospital, Taiwan.'}, {'ForeName': 'Meng-Yueh', 'Initials': 'MY', 'LastName': 'Chien', 'Affiliation': 'School and Graduate Institute of Physical Therapy and Center for Obesity, Lifestyle and Metabolic Surgery, National Taiwan University and Hospital, Taipei, Taiwan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8560']
77,32335900,"The impact of respiratory protective equipment on difficult airway management: a randomised, crossover, simulation study.","The current international COVID-19 health crisis underlines the importance of adequate and suitable personal protective equipment for clinical staff during acute airway management. This study compares the impacts of standard air-purifying respirators and powered air-purifying respirators during simulated difficult airway scenarios. Twenty-five anaesthetists carried out four different standardised difficult intubation drills, either unprotected (control), or wearing a standard or a powered respirator. Treatment times and wearer comfort were determined and compared. In the wearer comfort evaluation form, operators rated mobility, noise, heat, vision and speech intelligibility. All anaesthetists accomplished the treatment objectives of all study arms without adverse events. Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™; 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope; 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope; and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard tracheal intubation by direct laryngoscopy, respectively. Videolaryngoscopy allowed the shortest intubation times regardless of the respiratory protective device used. Anaesthetists rated heat and vision significantly higher in the powered respirator group; however, noise levels were perceived to be significantly lower than in the standard respirator group. We conclude that standard and powered respirators do not significantly prolong simulated advanced intubation procedures.",2020,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.",[],"['standard air purifying respirators and powered air purifying respirators', 'respiratory protective equipment', 'standardised difficult intubation drills, either unprotected (control), or wearing a standard, or a powered respirator', 'Videolaryngoscopy']","['Total mean (SD) intubation times', 'Anaesthetists rated heat and vision', 'operators rated mobility, noise, heat, vision, and speech intelligibility', 'Treatment times and wearer comfort', 'noise levels']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.0444717,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arlidge', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dudley', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sicinski', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Anaesthesia,['10.1111/anae.15102']
78,32250470,The effects of aripiprazole and olanzapine on pupillary light reflex and its relationship with pharmacogenetics in a randomized multiple-dose trial.,"AIMS


Pupillography is a noninvasive and cost-effective method to determine autonomic nerve activity. Genetic variants in cytochrome P450 (CYP), dopamine receptor (DRD2, DRD3), serotonin receptor (HTR2A, HTR2C) and ATP-binding cassette subfamily B (ABCB1) genes, among others, were previously associated with the pharmacokinetics and pharmacodynamics of antipsychotic drugs. Our aim was to evaluate the effects of aripiprazole and olanzapine on pupillary light reflex related to pharmacogenetics.
METHODS


Twenty-four healthy volunteers receiving 5 oral doses of 10 mg aripiprazole and 5 mg olanzapine tablets were genotyped for 46 polymorphisms by quantitative polymerase chain reaction. Pupil examination was performed by automated pupillometry. Aripiprazole, dehydro-aripiprazole and olanzapine plasma concentrations were measured by high-performance liquid chromatography-tandem mass spectrometry.
RESULTS


Aripiprazole affected pupil contraction: it caused dilatation after the administration of the first dose, then caused constriction after each dosing. It induced changes in all pupillometric parameters (P < .05). Olanzapine only altered minimum pupil size (P = .046). Polymorphisms in CYP3A, HTR2A, UGT1A1, DRD2 and ABCB1 affected pupil size, the time of onset of constriction, pupil recovery and constriction velocity. Aripiprazole, dehydro-aripiprazole and olanzapine pharmacokinetics were significantly affected by polymorphisms in CYP2D6, CYP3A, CYP1A2, ABCB1 and UGT1A1 genes.
CONCLUSIONS


In conclusion, aripiprazole and its main metabolite, dehydro-aripiprazole altered pupil contraction, but olanzapine did not have such an effect. Many polymorphisms may influence pupillometric parameters and several polymorphisms had an effect on aripiprazole, dehydro-aripiprazole and olanzapine pharmacokinetics. Pupillography could be a useful tool for the determination of autonomic nerve activity during antipsychotic treatment.",2020,"Aripiprazole, dehydro-aripiprazole and olanzapine pharmacokinetics were significantly affected by polymorphisms in CYP2D6, CYP3A, CYP1A2, ABCB1and UGT1A1 genes.
",['Twenty-four healthy volunteers receiving 5 oral doses of 10 mg'],"['Aripiprazole', 'Aripiprazole, dehydro-aripiprazole and olanzapine', 'olanzapine', 'aripiprazole', 'Pupillography', 'Olanzapine', 'aripiprazole and olanzapine', 'aripiprazole and 5 mg olanzapine tablets']","['pupil contraction', 'Polymorphisms in CYP3A, HTR2A, UDP-glucuronosyltransferase 1-1 (UGT1A1), DRD2 and ABCB1 affected pupil size, the time of onset of constriction, pupil recovery and constriction velocity', 'minimum pupil size', 'plasma concentrations', 'pupillary light reflex']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1872486', 'cui_str': 'dehydroaripiprazole'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1247204', 'cui_str': 'olanzapine Oral Tablet'}]","[{'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C1567723', 'cui_str': 'UGT1A1 protein, human'}, {'cui': 'C3659270', 'cui_str': 'DRD2 protein, human'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234671', 'cui_str': 'Pupil afferent light reaction'}]",24.0,0.0163892,"Aripiprazole, dehydro-aripiprazole and olanzapine pharmacokinetics were significantly affected by polymorphisms in CYP2D6, CYP3A, CYP1A2, ABCB1and UGT1A1 genes.
","[{'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Koller', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Saiz-Rodríguez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Zubiaur', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Ochoa', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Almenara', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Román', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Romero-Palacián', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'de Miguel-Cáceres', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Martín', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Navares-Gómez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Mejía', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Wojnicz', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Abad-Santos', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Pharmacology Department, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14300']
79,32338312,"Correction to: Effects of a resistance and balance exercise programme on physical fitness, health-related quality of life and fear of falling in older women with osteoporosis and vertebral fracture: a randomized controlled trial.","The original version of this article, published on 10 January 2020, contained a mistake. An author's name was misspelled.",2020,"The original version of this article, published on 10 January 2020, contained a mistake.",['older women with osteoporosis and vertebral fracture'],['resistance and balance exercise programme'],"['physical fitness, health-related quality of life and fear of falling']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",,0.0379202,"The original version of this article, published on 10 January 2020, contained a mistake.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Stanghelle', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway. bsugland@oslomet.no.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bentzen', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Giangregorio', 'Affiliation': 'Department of Kinesiology, Schlegel-UW Research Institute for Aging, University of Waterloo, 250 Laurelwood Dr, Waterloo, ON, N2J 0E2, Canada.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Centre for Living, Glasgow Caledonian University, Cowcaddens Rd, Glasgow, G4 0BA, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bergland', 'Affiliation': 'Institute of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05398-w']
80,31952851,Is It Time for a Randomized Controlled Trial of Hypothermia for Mild Hypoxic-Ischemic Encephalopathy?,,2020,,[],['Hypothermia'],[],[],"[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]",[],,0.157476,,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI.'}, {'ForeName': 'Sara V', 'Initials': 'SV', 'LastName': 'Bates', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI. Electronic address: sshankar@med.wayne.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.11.030']
81,31912785,Differential effects of an electronic symptom monitoring intervention based on the age of patients with advanced cancer.,"BACKGROUND


Symptom monitoring interventions enhance patient outcomes, including quality of life (QoL), health care utilization, and survival, but it remains unclear whether older and younger patients with cancer derive similar benefits. We explored whether age moderates the improved outcomes seen with an outpatient electronic symptom monitoring intervention.
PATIENTS AND METHODS


We carried out a secondary analysis of data from a randomized trial of 766 patients receiving chemotherapy for metastatic solid tumors. Patients received an electronic symptom monitoring intervention integrated with oncology care or usual oncology care alone. The intervention consisted of patients reporting their symptoms, which were provided to their physicians at clinic visits, and nurses receiving alerts for severe/worsening symptoms. We used regression models to determine whether age (older or younger than 70 years) moderated the effects of the intervention on QoL (EuroQol EQ-5D), emergency room (ER) visits, hospitalizations, and survival outcomes.
RESULTS


Enrollment rates for younger (589/777 = 75.8%) and older (177/230 = 77.0%) patients did not differ. Older patients (median age = 75 years, range 70-91 years) were more likely to have an education level of high school or less (26.6% versus 20.9%, P = 0.029) and to be computer inexperienced (50.3% versus 23.4%, P < 0.001) compared with younger patients (median age = 58 years, range 26-69 years). Younger patients receiving the symptom monitoring intervention experienced lower risk of ER visits [hazard ratio (HR) = 0.74, P = 0.011] and improved survival (HR = 0.76, P = 0.011) compared with younger patients receiving usual care. However, older patients did not experience significantly lower risk of ER visits (HR = 0.90, P = 0.613) or improved survival (HR = 1.06, P = 0.753) with the intervention. We found no moderation effects based on age for QoL and risk of hospitalizations.
CONCLUSIONS


Among patients with advanced cancer, age moderated the effects of an electronic symptom monitoring intervention on the risk of ER visits and survival, but not QoL. Symptom monitoring interventions may need to be tailored to the unique needs of older adults with cancer.",2020,"Younger patients receiving the symptom monitoring intervention experienced lower risk of ER visits [hazard ratio (HR) = 0.74, P = 0.011] and improved survival (HR = 0.76, P = 0.011) compared with younger patients receiving usual care.","['Older patients (median age\xa0= 75 years, range 70-91 years', 'younger patients (median age\xa0= 58 years, range 26-69 years', 'age (older or younger than 70 years', 'older and younger patients with cancer', '766 patients receiving chemotherapy for metastatic solid tumors', 'patients with advanced cancer', 'older adults with cancer']","['electronic symptom monitoring intervention', 'electronic symptom monitoring intervention integrated with oncology care or usual oncology care alone']","['survival', 'QoL (EuroQol EQ-5D), emergency room (ER) visits, hospitalizations, and survival outcomes', 'quality of life (QoL), health care utilization, and survival', 'risk of ER visits']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0034380'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",766.0,0.0472507,"Younger patients receiving the symptom monitoring intervention experienced lower risk of ER visits [hazard ratio (HR) = 0.74, P = 0.011] and improved survival (HR = 0.76, P = 0.011) compared with younger patients receiving usual care.","[{'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA. Electronic address: RNipp@MGH.Harvard.edu.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Horick', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Rogak', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fuh', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital & Harvard Medical School, Boston, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Scottsdale, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Department of Medicine, Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center & Harvard Medical School, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.09.003']
82,31993781,Low-dose ofatumumab for multidrug-resistant nephrotic syndrome in children: a randomized placebo-controlled trial.,"BACKGROUND


Children with multidrug-resistant nephrotic syndrome (MRNS) are exposed to drug toxicity (steroids/calcineurin inhibitors (CNI)/mycophenolate mofetil (MMF)) and have an increased risk of kidney disease progression. In small case series, the fully humanized anti-CD20 antibody ofatumumab (OFA) induced remission in children with MRNS when at high dose (10,300 mg/1.73 m 2 ) and partial remission at standard dose (1000 mg/1.73 m 2 ).
METHODS


This double-blind randomized placebo-controlled trial tested the efficacy of single infusion OFA in children with proven MRNS and initial chronic renal failure (eGFR [median/range] 119/38-155 ml/min/1.73 m 2  in Placebo arm vs. 65/19-103 ml/min/1.73 m 2  Intervention). Children who had been resistant to a combination of CNI and steroids, with or without MMF or rituximab, were randomized to receive single infusion OFA (1500 mg/1.73 m 2 ) (Intervention arm) or normal saline (Placebo arm). We assessed complete or partial remission of proteinuria after 3 months (primary outcome), and after 6 and 12 months (secondary outcomes), as well as progression to end-stage kidney disease.
RESULTS


After 13 of the planned 50 children (25%) were randomized, the data safety and monitoring board recommended study termination for futility. All 13 children remained nephrotic. Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period. Circulating CD20 was reduced following OFA infusion and remained low for > 3 months.
CONCLUSIONS


OFA given in one single infusion of 1500 mg/1.73 m 2  doses does not induce remission in MRNS. Regimens based on higher OFA doses should be tested in clinical trials.
TRIAL REGISTRATION


https://clinicaltrials.gov: NCT02394106.",2020,"Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period.","['Children with multidrug-resistant nephrotic syndrome (MRNS', 'children', 'After 13 of the planned 50 children (25', 'children with proven MRNS and initial chronic renal failure (eGFR [median/range] 119/38-155\xa0ml', 'Children who had been resistant to a combination of CNI and steroids, with or without MMF or']","['Placebo', 'rituximab', 'normal saline (Placebo', 'renal replacement therapy', 'placebo', 'single infusion OFA', 'toxicity (steroids/calcineurin inhibitors (CNI)/mycophenolate mofetil (MMF', 'OFA']","['Renal function', 'progression to end-stage kidney disease', 'Circulating CD20', 'complete or partial remission of proteinuria', 'nephrotic']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",5.0,0.799336,"Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period.","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Pisani', 'Affiliation': 'Division of Nephrology, School of Nephrology, Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bodria', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Caridi', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Maria Ludovica', 'Initials': 'ML', 'LastName': ""Degl'Innocenti"", 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.'}, {'ForeName': 'Gian Marco', 'Initials': 'GM', 'LastName': 'Ghiggeri', 'Affiliation': 'Laboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy. gmarcoghiggeri@gaslini.org.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04481-y']
83,32316957,A study protocol for a clustered randomised controlled trial to evaluate the effectiveness of a peer-led school-based walking intervention on adolescent girls' physical activity: the Walking In ScHools (WISH) study.,"BACKGROUND


Adolescent girls in the UK and Ireland are failing to meet current physical activity guidelines. Physical activity behaviours track from childhood to adulthood and it is important that adolescent girls are provided with opportunities to be physically active. Walking has been a central focus for physical activity promotion in adults and may effectively increase physical activity levels among younger people. Following on from a pilot feasibility trial, the purpose of this cluster randomised controlled trial (c-RCT) is to evaluate the effectiveness of a novel, low-cost, peer-led school-based walking intervention delivered across the school year at increasing physical activity levels of adolescent girls.
METHODS


The Walking In ScHools (WISH) Study is a school-based c-RCT conducted with girls aged 12-14 years from eighteen schools across the Border Region of Ireland / Northern Ireland. Following baseline data collection, schools will be randomly allocated to intervention or control group. In intervention schools, female pupils aged 15-18 years will be invited to train as walk leaders and will lead younger pupils in 10-15 min walks before school, at break and lunch recess. All walks will take place in school grounds and pupils will be encouraged to participate in as many walks as possible each week. The intervention will be delivered for the whole school year (minimum 20-22 weeks). The primary outcome measure is accelerometer-measured total physical activity (counts per minute) (end of intervention). Secondary outcomes will include time spent in sedentary behaviour, light, moderate and vigorous intensity physical activity, anthropometry measures, social media usage and sleep. A mixed-methods process evaluation will also be undertaken.
DISCUSSION


The WISH Study will examine the effectiveness of a low-cost, school-based, peer-led walking intervention in increasing physical activity in adolescent girls when delivered across the school year. If the intervention increases physical activity, it would benefit adolescent girls in the defined target area with potential for wider adoption by schools across the UK and Ireland.
TRIAL REGISTRATION


ISRCTN; ISRCTN12847782; Registered 2nd July 2019.",2020,"If the intervention increases physical activity, it would benefit adolescent girls in the defined target area with potential for wider adoption by schools across the UK and Ireland.
","['girls aged 12-14\u2009years from eighteen schools across the Border Region of Ireland / Northern Ireland', 'adolescent girls', 'Adolescent girls', ""adolescent girls' physical activity"", 'female pupils aged 15-18\u2009years']","['low-cost, school-based, peer-led walking intervention', 'novel, low-cost, peer-led school-based walking intervention', 'peer-led school-based walking intervention']","['physical activity', 'physical activity levels', 'accelerometer-measured total physical activity (counts per minute) (end of intervention', 'time spent in sedentary behaviour, light, moderate and vigorous intensity physical activity, anthropometry measures, social media usage and sleep']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0454906', 'cui_str': 'Border region'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0788694,"If the intervention increases physical activity, it would benefit adolescent girls in the defined target area with potential for wider adoption by schools across the UK and Ireland.
","[{'ForeName': 'S Maria', 'Initials': 'SM', 'LastName': ""O'Kane"", 'Affiliation': 'Centre for Exercise Medicine, Physical Activity and Health, Sports and Exercise Sciences Research Institute, University of Ulster, Jordanstown Campus, Newtownabbey, BT37 0QB, UK. m.okane@ulster.ac.uk.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Carlin', 'Affiliation': 'Centre for Exercise Medicine, Physical Activity and Health, Sports and Exercise Sciences Research Institute, University of Ulster, Jordanstown Campus, Newtownabbey, BT37 0QB, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Gallagher', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Biomedical Sciences Research Institute, University of Ulster, Coleraine Campus, Coleraine, BT52 1SA, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Lahart', 'Affiliation': 'Faculty of Education, Health and Wellbeing, University of Wolverhampton, Walsall Campus, Gorway Road, Walsall, WS1 3BD, UK.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Jago', 'Affiliation': 'Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, University of Bristol, Bristol, BS8 1TZ, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Faulkner', 'Affiliation': 'Department of Law and Humanities, Letterkenny Institute of Technology, Port Road, Letterkenny, Ireland.'}, {'ForeName': 'Marie H', 'Initials': 'MH', 'LastName': 'Murphy', 'Affiliation': 'Centre for Exercise Medicine, Physical Activity and Health, Sports and Exercise Sciences Research Institute, University of Ulster, Jordanstown Campus, Newtownabbey, BT37 0QB, UK.'}]",BMC public health,['10.1186/s12889-020-08600-0']
84,32397926,"2B, 2C, or 3: What Should Be the Angiographic Target for Endovascular Treatment in Ischemic Stroke?","Background and Purpose- A score of ≥2B on the modified Thrombolysis in Cerebral Infarction scale is generally regarded as successful reperfusion after endovascular treatment for ischemic stroke. The extended Thrombolysis in Cerebral Infarction (eTICI) includes a 2C grade, which indicates near-perfect reperfusion. We investigated how well the respective eTICI scores of 2B, 2C, and 3 correlate with clinical outcome after endovascular treatment. Methods- We used data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands. We included patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available. Our primary outcome was the distribution on the modified Rankin Scale at 90 days per eTICI grade. We performed (ordinal) logistic regression analyses, using eTICI 2B as reference group, and adjusted for potential confounders. Results- In total, 2807/3637 (77%) patients met the inclusion criteria. Of these, 17% achieved reperfusion grade eTICI 0 to 1, 14% eTICI 2A, 25% eTICI 2B, 12% eTICI 2C, and 32% eTICI 3. Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01). Procedure times decreased with increasing reperfusion grades. We found a positive association between reperfusion grade and functional outcome, which continued to increase after eTICI 2B (adjusted common odds ratio, 1.22 [95% CI, 0.96-1.57] for eTICI 2C versus 2B; adjusted common odds ratio, 1.33 [95% CI, 1.09-1.62] for eTICI 3 versus 2B). Conclusions- Our results indicate a continuous relationship between reperfusion grade and functional outcome, with eTICI 3 leading to the best outcomes. Although this implies that interventionists should aim for the highest possible reperfusion grade, further research on the optimal strategy is necessary.",2020,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"['patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available', 'Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands']","['Methods', 'Endovascular Treatment', ' and Purpose', 'Conclusions']","['reperfusion grade eTICI', 'Cerebral Infarction scale', 'occlusion location', 'distribution on the modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",,0.078079,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'LeCouffe', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Center for Medical Decision Making, Erasmus MC University Medical Center Rotterdam, the Netherlands (H.F.L.).'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, China (G.Z.).'}, {'ForeName': 'Ido R', 'Initials': 'IR', 'LastName': 'van den Wijngaard', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, the Hague, the Netherlands (I.R.v.d.W.).'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center Rotterdam, the Netherlands (A.C.G.M.v.E.).'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028891']
85,32229029,"Evaluation of the Efficacy of Erbium, Chromium-doped Yttrium, Scandium, Gallium, and Garnet Laser in Partial Pulpotomy in Permanent Immature Molars: A Randomized Controlled Trial.","INTRODUCTION


The use of the erbium, chromium-doped yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser in vital pulp therapy contributes to the formation of dentin bridges and a sterile zone as well as the maintenance of the vitality of the pulp. However, no prior studies have used the Er,Cr:YSGG laser in partial pulpotomy of immature permanent teeth. The aim of this study was to compare the efficacy of partial pulpotomy treatment using mineral trioxide aggregate (MTA) alone and MTA with the Er,Cr:YSGG laser in permanent immature molars.
METHODS


A total of 90 caries-exposed permanent immature molar teeth were included and randomly divided into 2 groups: the MTA group (n = 45) and the laser + MTA group (n = 45). In the MTA group, MTA was applied to the exposed area on the pulp after bleeding control. In the same session, the tooth was restored with a composite resin. In the laser + MTA group, before MTA condensation, the Er,Cr:YSGG laser was applied to the exposure area. Patients were recalled at 1, 3, 6, and 12 months after treatment. The Mann-Whitney U and chi-Square tests were used for statistical analysis.
RESULTS


The success rate (95.5%) of the laser + MTA group was similar to that of the MTA group (88.8%). There was no significant difference between groups in terms of the frequency of at least 1 pathologic clinical or radiographic failure at 12 months (P > .05).
CONCLUSIONS


Partial pulpotomy treatment showed a high success rate in immature permanent molars; however, the use of the laser did not contribute to the success rate compared with MTA alone.",2020,"There was no significant difference between groups in terms of the frequency of at least 1 pathologic clinical or radiographic failure at 12 months (P > .05).
","['Permanent Immature Molars', 'permanent immature molars', '90 caries-exposed permanent immature molar teeth']","['erbium, chromium-doped yttrium, scandium, gallium, and garnet', 'partial pulpotomy treatment using mineral trioxide aggregate (MTA) alone and MTA with the Er,Cr:YSGG laser', 'Erbium, Chromium-doped Yttrium, Scandium, Gallium, and Garnet Laser', 'MTA', 'laser + MTA']","['frequency of at least 1 pathologic clinical or radiographic failure', 'success rate']","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0036274', 'cui_str': 'Scandium'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",90.0,0.0232544,"There was no significant difference between groups in terms of the frequency of at least 1 pathologic clinical or radiographic failure at 12 months (P > .05).
","[{'ForeName': 'Kamile Nur', 'Initials': 'KN', 'LastName': 'Tozar', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Kırıkkale University, Kırıkkale, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Erkmen Almaz', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Kırıkkale University, Kırıkkale, Turkey. Electronic address: dt.merveerkmen@gmail.com.'}]",Journal of endodontics,['10.1016/j.joen.2020.02.003']
86,31029655,An analysis of delays among women accessing second-trimester abortion in the public sector in South Africa.,"OBJECTIVES


To identify key delays and associated factors in women's pathway to second-trimester abortion that could inform strategies to increase earlier presentation.
STUDY DESIGN


We performed a secondary analysis using data collected from May 2012 to June 2013 as part of a randomized controlled trial among women having abortion at 13.0-20.0 weeks at a public hospital in South Africa. We used ultrasound and participant interview data to calculate 3 key intervals: (1) conception to suspicion of pregnancy, (2) suspicion to first healthcare visit for abortion, and (3) first healthcare visit to abortion procedure. We compared intervals for women at 13-15.0 weeks versus 15.1-20.0 weeks gestation at abortion using Wilcoxon rank-sum tests and tested for associations between gestational age at key events using multivariable linear regression.
RESULTS


Median (interquartile range[IQR]) durations for the 3 intervals among women at 13-15 weeks (n=93) compared to 15.1-20 weeks (n=63) gestation were: (1) 36 days (IQR 21-53 days) versus 62 days (36-71 days), p<.001; (2) 29 days (IQR 15-46 days) versus 23 days (IQR 11-39 days), p=.64; (3) 14 days (IQR 7-21 days) versus 14 days (IQR 12-21 days), p=.32. Multivariable logistic regression showed marginal associations between gestational age at suspicion of pregnancy and no prior pregnancy (aOR=3.8, 95% CI 1.0-14.6) and living in informal housing (aOR=3.1, 95% CI 1.0-9.1). Gestational age on the day of the abortion procedure was significantly associated with living in informal housing (aOR=3.1, 95% CI 1.4-6.6).
CONCLUSION


The only differences in delay in obtaining second trimester abortion between South African women having an earlier and later second trimester procedure is due to longer time to suspect pregnancy.
IMPLICATIONS


Interventions to improve early pregnancy recognition should be explored and referral processes should be streamlined to avoid unnecessary delays accessing abortion care and possibly reduce the proportion of abortions performed later in the second trimester in South Africa.",2019,"Gestational age on the day of the abortion procedure was significantly associated with living in informal housing (aOR=3.1, 95% CI 1.4-6.6).
","['women having abortion at 13.0-20.0 weeks at a public hospital in South Africa', 'women accessing second-trimester abortion in the public sector in South Africa']",[],"['Median (interquartile range[IQR]) durations', 'living in informal housing']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]",,0.147856,"Gestational age on the day of the abortion procedure was significantly associated with living in informal housing (aOR=3.1, 95% CI 1.4-6.6).
","[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Constant', 'Affiliation': ""Women's Health Research Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa. Electronic address: deborah.constant@uct.ac.za.""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Kluge', 'Affiliation': 'Department of Obstetrics & Gynaecology, University of Stellenbosch and Tygerberg Hospital, Cape Town, South Africa. Electronic address: judykluge@sun.ac.za.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Harries', 'Affiliation': ""Women's Health Research Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa. Electronic address: jane.harries@uct.ac.za.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grossman', 'Affiliation': 'Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, Oakland, California, USA. Electronic address: Daniel.Grossman@ucsf.edu.'}]",Contraception,['10.1016/j.contraception.2019.04.009']
87,32013825,The Mediating Effect of Different Exercise Programs on the Immune Profile of Frail Older Women with Cognitive Impairment.,"BACKGROUND


Frail individuals experience an accelerated immunosenescence, and exercise has been identified as a therapy to promote a better inflammatory environment.
OBJECTIVE


To analyze the effects of 28-weeks of two different exercise protocols on the functional fitness and immune profiles of institutionalized pre-frail and frail women with mild cognitive impairment.
METHODS


Participants residing in care homes (n=60, 81±7.84 years old) were randomized into three groups: a chair elastic band muscle-strength exercise (CSE, n=21; 81±4.79), a chair multimodal exercise (CME, n=20; 80±8.19), and a control non-exercise (CGne, n=19; 80±10.01). Both CME and CSE groups performed progressive circuit-training exercise sessions. The controls did not change their usual lifestyle. The Fried protocol and the Mini-Mental State Examination questionnaire were used to identify the frail subgroups and the participants with mild cognitive impairment. Data for anti and pro-inflammatory markers and physical fitness were analyzed pre and post-interventions.
RESULTS


After the intervention, a significant effect of time and time by group for sIgA and time by group for IL- 10 levels were found (p > 0.05). Within-group analysis showed a significant moderate decrease in the TNF-α to IL-10 ratio for the CME group and an increase in the controls (p > 0.05) and a slight reduction in the IL-6 and IL- 1β concentrations. The controls showed a negative trend towards a decrease in physical fitness and a trend for increased levels in the pro-inflammatory markers IL-6 and IL-1β.
CONCLUSION


The evidence regarding the use of systematic and moderate long-term exercise as therapy for promoting a better balance between pro- and anti-inflammatory environments and a decrease in the inflammatory index for the CME group were the most promising results from this study.",2020,Within-group analysis showed a significant moderate decrease in the TNF-α to IL-10 ratio for the CME group and an increase in the controls (p > 0.05) and a slight reduction in the IL-6 and IL-1β concentrations.,"['Participants residing in care homes (n=60, 81±7.84 years old', 'institutionalized pre-frail and frail women with mild cognitive impairment', 'frail older women with cognitive impairment', 'participants with mild cognitive impairment']","['exercise protocols', 'control non-exercise', 'chair elastic band muscle-strength exercise (CSE', 'Mini Mental State Examination questionnaire', 'chair multimodal exercise (CME', 'exercise programs']","['TNF-α to IL-10 ratio', 'inflammatory index', 'IL-6 and IL-1β concentrations', 'functional fitness and immune profiles', 'physical fitness', 'IL-10 levels']","[{'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0419118', 'cui_str': 'Muscle strength exercise (regime/therapy)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0290119,Within-group analysis showed a significant moderate decrease in the TNF-α to IL-10 ratio for the CME group and an increase in the controls (p > 0.05) and a slight reduction in the IL-6 and IL-1β concentrations.,"[{'ForeName': 'Furtado G', 'Initials': 'FG', 'LastName': 'Eustáquio', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Chupel M', 'Initials': 'CM', 'LastName': 'Uba', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Minuzzi L', 'Initials': 'ML', 'LastName': 'Guerra', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Luis', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Colado J', 'Initials': 'CJ', 'LastName': 'Carlos', 'Affiliation': 'Reserch Unit in Sport and Health, Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Hogervorst', 'Initials': 'H', 'LastName': 'Eef', 'Affiliation': 'School of Sport and Exercise Sciences, Loughborough University, Leicestershire, United Kingdom.'}, {'ForeName': 'Ferreira J', 'Initials': 'FJ', 'LastName': 'Pedro', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Teixeira A', 'Initials': 'TA', 'LastName': 'Maria', 'Affiliation': 'Research Center for Sport and Physical Activity, CIDAF (UID/PTD/04213/2019), Faculty of Sports Sciences and Physical Education (FCDEF-UC) - University of Coimbra, Coimbra, Portugal.'}]",Current pharmaceutical design,['10.2174/1381612826666200203123258']
88,32171169,Gait changes following direct versus contralateral strength training: A randomized controlled pilot study in individuals with multiple sclerosis.,"BACKGROUND


Contralateral strength training (CST) is increasingly investigated and employed as a non-conventional way to induce an indirect gain in strength in the weakened untrained limb. However, its effects on gait performance are more controversial.
RESEARCH QUESTION


To assess and compare the effects of contralateral (CST) and direct (DST) strength training on spatio-temporal parameters, kinematic and kinetic descriptors of gait in persons with relapsing-remitting multiple sclerosis (PwMS).
METHODS


Twenty-eight PwMS (EDSS 2.0-5.5) with inter-side difference in ankle dorsiflexors' strength ≥ 20 % and moderate gait impairment (walking speed 0.70-0.94 m/s), were randomly assigned to a CST (undergoing training of the less-affected dorsiflexors) or DST group (where the most-affected dorsiflexors were trained). Before and after a 6-week high-intensity resistance training (three 25-minute sessions/week), PwMS underwent bilateral measurements of dorsiflexors' maximal strength and assessment of gait spatio-temporal parameters, lower limb joint kinematics and kinetics.
RESULTS AND SIGNIFICANCE


Following the training period, muscle strength increased significantly in both groups (on average, CST + 29.5 %, p < 0.0005; DST + 15.7 %, p = 0.001) with no difference between the two interventions. Significant changes in gait speed (+16.5 %; p < 0.0001) and stride length (+6.0 %; p = 0.04) were detected only after DST, while no difference was detected in the CST group. Ankle moment and ROM were unaffected by the training. In PwMS with mild to moderate disability and lower limb dorsiflexors' strength asymmetry, CST was not inferior to DST in inducing significant strength gains in the untrained most-affected limb. However, only DST significantly improved gait performance and, specifically, walking speed. Even though CST did not worsen asymmetry, data suggest that contralateral approaches should not be recommended straightaway if the training goal is to improve outcomes other than strength and, specifically, walking speed.",2020,"p < 0.0001) and stride length (+6.0 %; p = 0.04) were detected only after DST, while no difference was detected in the CST group.","['persons with relapsing-remitting multiple sclerosis (PwMS', ""Twenty-eight PwMS (EDSS 2.0-5.5) with inter-side difference in ankle dorsiflexors' strength ≥ 20 % and moderate gait impairment (walking speed 0.70-0.94\u2009m/s"", 'individuals with multiple sclerosis']","['contralateral (CST) and direct (DST) strength training', 'CST', 'CST (undergoing training of the less-affected dorsiflexors) or DST', 'Contralateral strength training (CST', 'direct versus contralateral strength training']","['muscle strength', 'stride length', 'gait performance and, specifically, walking speed', 'gait performance', 'Ankle moment and ROM', 'gait speed', 'strength gains', 'Gait changes']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C4517487', 'cui_str': '0.94 (qualifier value)'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0326216,"p < 0.0001) and stride length (+6.0 %; p = 0.04) were detected only after DST, while no difference was detected in the CST group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manca', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Peruzzi', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aiello', 'Affiliation': 'Department of Medical, Surgical and Experimental Sciences, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cereatti', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Deriu', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy. Electronic address: deriuf@uniss.it.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Della Croce', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, Sassari, Italy.'}]",Gait & posture,['10.1016/j.gaitpost.2020.02.017']
89,31468735,Promoting social attention in 3-year-olds with ASD through gaze-contingent eye tracking.,"Young children with autism spectrum disorder (ASD) look less toward faces compared to their non-ASD peers, limiting access to social learning. Currently, no technologies directly target these core social attention difficulties. This study examines the feasibility of automated gaze modification training for improving attention to faces in 3-year-olds with ASD. Using free-viewing data from typically developing (TD) controls (n = 41), we implemented gaze-contingent adaptive cueing to redirect children with ASD toward normative looking patterns during viewing of videos of an actress. Children with ASD were randomly assigned to either (a) an adaptive Cue condition (Cue, n = 16) or (b) a No-Cue condition (No-Cue, n = 19). Performance was examined at baseline, during training, and post-training, and contrasted with TD controls (n = 23). Proportion of time looking at the screen (%Screen) and at actresses' faces (%Face) was analyzed. At Pre-Training, Cue and No-Cue groups did not differ in %Face (P > 0.1). At Post-Training, the Cue group had higher %Face than the No-Cue group (P = 0.015). In the No-Cue group %Face decreased Pre- to Post-Training; no decline was observed in the Cue group. These results suggest gaze-contingent training effectively mitigated decreases of attention toward the face of onscreen social characters in ASD. Additionally, larger training effects were observed in children with lower nonverbal ability, suggesting a gaze-contingent approach may be particularly relevant for children with greater cognitive impairment. This work represents development toward new social attention therapeutic systems that could augment current behavioral interventions. Autism Res 2020, 13: 61-73. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: In this study, we leverage a new technology that combines eye tracking and automatic computer programs to help very young children with ASD look at social information in a more prototypical way. In a randomized controlled trial, we show that the use of this technology prevents the diminishing attention toward social information normally seen in children with ASD over the course of a single experimental session. This work represents development toward new social attention therapeutic systems that could augment current behavioral interventions.",2020,In the No-Cue group %Face decreased Pre- to Post-Training; no decline was observed in the Cue group.,"['children with ASD', '3-year-olds with ASD', 'young children with ASD look at social information in a more prototypical way', 'Young children with autism spectrum disorder (ASD', 'Children with ASD']","['automated gaze modification training', 'adaptive Cue condition (Cue, n\u2009=\u200916) or (b) a No-Cue condition', 'implemented gaze-contingent adaptive cueing to redirect children with ASD toward normative looking patterns during viewing of videos of an actress', 'combines eye tracking and automatic computer programs']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}]",[],,0.0124381,In the No-Cue group %Face decreased Pre- to Post-Training; no decline was observed in the Cue group.,"[{'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Wall', 'Affiliation': 'Department of School Psychology, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Barney', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Bradshaw', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Macari', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Chawarska', 'Affiliation': 'Child Study Center, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Shic', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington.""}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2199']
90,32328440,Internet-based self-help intervention aimed at increasing social self-efficacy among internal migrants in Poland: Study protocol for a randomized controlled trial.,"Background


Migration is a challenging life transition that may be a source of various problems related to well-being and mental health. However, the psychological adaptation of migrants may be potentially facilitated by social self-efficacy-the beliefs in one's ability to initiate and maintain interpersonal relationships. Previous research suggests that social self-efficacy is positively related to adjustment and negatively related to loneliness, depression, and psychological distress. Research also confirms that self-efficacy beliefs can be effectively enhanced using Internet-based interventions. These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to sources of self-efficacy beliefs: mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states. Users complete increasingly challenging tasks that encourage them to interact with their environment. The aim of this trial was to investigate the efficacy of the New in Town intervention.
Methods


The efficacy of the New in Town intervention will be tested in a two-arm randomized controlled trial with a waitlist control group. Social self-efficacy will be the primary outcome. Secondary outcomes will include loneliness, perceived social support, and satisfaction with life. Additionally, we will measure user experience among participants allocated to the experimental group. We aim to recruit a total of  N  = 280 participants aged at least 18 years who have changed their place of residence in the last 6 months and have an Internet connection. Participants will be assessed at baseline, 3-week post-test, and 8-week follow-up.
Discussion


The trial will provide insights into the efficacy of Internet-based self-help interventions in increasing social self-efficacy. Given that the intervention works, New in Town could provide an easily accessible support option for internal migrants in Poland.
Trial registration


The trial was registered with ClinicalTrials.gov (identifier: NCT04088487) on 11th September 2019.",2020,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.",['total of  N \u202f=\u202f280 participants aged at least 18\u202fyears who have changed their place of residence in the last 6\u202fmonths and have an Internet connection'],"['Internet-based self-help intervention', 'Internet-based self-help interventions']","['Social self-efficacy', 'loneliness, perceived social support, and satisfaction with life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",280.0,0.0703208,"These results served as a background for creating the New in Town, a self-help Internet-based intervention for internal migrants in Poland that aims at increasing social self-efficacy.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rogala', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Szczepaniak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Internet interventions,['10.1016/j.invent.2020.100322']
91,32234334,Action observation treatment improves gait ability in subacute to convalescent stroke patients.,"The aim of this study was to investigate the effects of action observation treatment (AOT) on gait ability in patients with subacute to convalescent stroke. Sixteen patients with subacute stroke were divided into a control group (n = 8) and AOT group (n = 8) when admitted to the convalescent ward. The control group received a conventional rehabilitation only. In addition to conventional rehabilitation, the AOT received AOT for 3 months (30 min per day 5 times per week). The AOT involved observing the action of another subject in a comfortable gait situation from the front, sides, and back via video and conducting the actual action. All participants were assessed during the main-assessment period, which included a baseline (i.e., when admitted to the convalescent ward) and 1, 2, and 3 months after baseline. The sub-assessment period at 2 and 3 months after baseline was conducted with participants who could walk independently. The main outcomes of the main-assessment and sub-assessment periods were Functional Ambulation Classification (FAC) and the 10-m walk test (10MWT), respectively. With respect to the FAC, we used a split plot design analysis of covariance to test the interaction between assessment time and group. There was no significant interaction between assessment time and group in FAC. However, a significant improvement of the 10MWT in the sub-assessment period was observed in the AOT group, but not the control group. Our results indicate that AOT may be an effective therapy for patients with subacute to convalescent stroke who can walk independently.",2020,"However, a significant improvement of the 10MWT in the sub-assessment period was observed in the AOT group, but not the control group.","['patients with subacute to convalescent stroke', 'Sixteen patients with subacute stroke', 'subacute to convalescent stroke patients', 'patients with subacute to convalescent stroke who can walk independently']","['action observation treatment (AOT', 'conventional rehabilitation only', 'AOT']","['main-assessment and sub-assessment periods were Functional Ambulation Classification (FAC) and the 10-m walk test (10MWT', 'gait ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",16.0,0.0140664,"However, a significant improvement of the 10MWT in the sub-assessment period was observed in the AOT group, but not the control group.","[{'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Hioka', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Tokushima Bunri University, Tokushima City, Japan. Electronic address: hioka@tks.bunri-u.ac.jp.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Department of Neurosurgery, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima City, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Kitazato', 'Affiliation': 'Department of Neurosurgery, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima City, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Akazawa', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Tokushima Bunri University, Tokushima City, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Department of Neurosurgery, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima City, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nagahiro', 'Affiliation': 'Yoshinogawa Hospital, Itano-gun, Japan.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.03.031']
92,32331584,"Corrigendum to ""van Bommel EJM, Muskiet MHA, van Baar MJB, et al. The renal hemodynamic effects of the SGLT2 inhibitor dapagliflozin are caused by post-glomerular vasodilatation rather than pre-glomerular vasoconstriction in metformin-treated patients with type 2 diabetes in the randomized, double-blind RED trial."" Kidney Int. 2020;97:202-212.",,2020,,['treated patients with type 2 diabetes'],"['metformin', 'SGLT2 inhibitor dapagliflozin']",['renal hemodynamic effects'],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0995255,,[],Kidney international,['10.1016/j.kint.2020.03.009']
93,31982170,Evaluation of the efficacy of postoperative antibiotic treatment in transoral endoscopic thyroidectomy: a prospective randomised controlled trial.,"Transoral endoscopic thyroid surgery (TOET) is a new, minimally-invasive approach that does not result in a scar in the anterior neck. To prevent infection of the surgical site from oral cavity flora into the thyroidectomy area, postoperative antibiotics are generally given orally for 3-7 days. However, there is no clinical evidence to support this approach. This study was an open-label, randomised, controlled trial to evaluate the clinical usefulness of postoperative antibiotics given orally to patients having TOET. Patients were randomly assigned to receive amoxicillin-clavulanate 625mg orally three times a day for a week after operation (treated group) or no antibiotics (untreated group). Fifty patients - 25 treated and 25 untreated - were enrolled. Maximum body temperature, pulse rate, white blood cell count, and C-reactive protein concentrations did not differ between the two groups. Evaluation of the surgical site showed no significant differences between them. Seven patients in the treated group developed nausea, vomiting, and diarrhoea compared with none in the untreated group. The results suggest that postoperative oral antibiotics are not essential after TOET. Large-scale prospective series are required to confirm this finding.",2020,"Maximum body temperature, pulse rate, white blood cell count, and C-reactive protein concentrations did not differ between the two groups.","['Fifty patients - 25 treated and 25 untreated - were enrolled', 'transoral endoscopic thyroidectomy', 'patients having TOET']","['Transoral endoscopic thyroid surgery (TOET', 'postoperative antibiotic treatment', 'amoxicillin-clavulanate 625mg orally three times a day for a week after operation (treated group) or no antibiotics', 'postoperative antibiotics']","['Maximum body temperature, pulse rate, white blood cell count, and C-reactive protein concentrations', 'nausea, vomiting, and diarrhoea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0110038', 'cui_str': 'Clavulanate'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.0480307,"Maximum body temperature, pulse rate, white blood cell count, and C-reactive protein concentrations did not differ between the two groups.","[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Yi', 'Affiliation': 'Department of Surgery, Inha University Hospital, Incheon, Republic of Korea; Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: gnsljw@gmail.com.'}, {'ForeName': 'S-J', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.01.004']
94,32131127,"A Randomized, Double-Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Patients with Visual Impairment due to Diabetic Macular Edema (KITE).","BACKGROUND


Brolucizumab is a single-chain variable antibody fragment (scVF) that specifically binds to VEGF-A. The results of two large phase III, multicentre, randomized clinical trials comparing intravitreal treatment with Brolucizumab and Aflibercept in neovascular age-related degeneration demonstrated its potency in the treatment of neovascular age-related macular degeneration (nAMD).
METHODS


The currently tested injected dose of 6 mg Brolucizumab results in a 11.2 - 13.3 times higher equivalent molar dose compared to Aflibercept 2 mg. Thus, it is conceivable that the effect of Brolucizumab in DME exceeds that of other currently used anti-VEGF agents with regards to effect durability; this was confirmed for nAMD in a phase I/II study.
RESULTS


Approved anti-VEGF drugs have shown unprecedented success compared to laser treatment with regards to restoration of visual acuity and improvement of diabetic retinopathy severity scores for up to 5 years. The visual gains were sustained after the loading phase and a reduced number of injections were required after the first year independent of the treatment strategy. Compared to pan-retinal laser photocoagulation, the time to progression of DRP was markedly extended and was proven by better preservation of the visual field, prevention of severe vision loss, hemorrhagic complications, and the need for intraocular surgery.
CONCLUSIONS


The ongoing prospective, randomized, phase III clinical studies in DME, KITE, and KESTREL aim to confirm the non-inferiority of Brolucizumab 6 mg compared to Aflibercept 2 mg on a functional and morphological level as well as durability effect over 2 years.",2020,The visual gains were sustained after the loading phase and a reduced number of injections were required after the first year independent of the treatment strategy.,"['Patients with Visual Impairment due to Diabetic Macular Edema (KITE', 'neovascular age-related macular degeneration (nAMD']","['pan-retinal laser photocoagulation', 'Brolucizumab versus Aflibercept', 'Brolucizumab and Aflibercept', 'Brolucizumab', 'Aflibercept']","['severe vision loss, hemorrhagic complications', 'diabetic retinopathy severity scores', 'Efficacy and Safety', 'visual gains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0336865', 'cui_str': 'Kite, device (physical object)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0852815', 'cui_str': 'Laser photocoagulation to retina'}, {'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",,0.0738441,The visual gains were sustained after the loading phase and a reduced number of injections were required after the first year independent of the treatment strategy.,"[{'ForeName': 'Justus G', 'Initials': 'JG', 'LastName': 'Garweg', 'Affiliation': 'Clinic for Vitreoretinal Disease, Swiss Eye Institute, Bern, Switzerland.'}]",Klinische Monatsblatter fur Augenheilkunde,['10.1055/a-1101-9126']
95,32173020,Quantitative Assessment of Intracanal Regenerated Tissues after Regenerative Endodontic Procedures in Mature Teeth Using Magnetic Resonance Imaging: A Randomized Controlled Clinical Trial.,"INTRODUCTION


The present study quantitatively assessed tissue regeneration after regenerative endodontic procedures (REPs) with 2 different apical preparation sizes in mature teeth using magnetic resonance imaging (MRI).
METHODS


Eighteen maxillary anterior mature necrotic teeth with periapical lesions were selected for the study. The teeth were randomly allocated into 2 groups. Canal preparation was performed using Protaper Next files (Dentsply Sirona, York, PA) until size X3 and X5 in the test and control groups, respectively. REPs were performed, and Biodentine (Septodont, Saint-Maur-des-Fossés, France) was used as the cervical plug material. In both groups, MRI was used to measure the signal intensity (SI) of the regenerated tissue at 3, 6, and 12 months at both the middle and the apical thirds of the canal. The SI between the normal contralateral teeth and each successive interval was compared. Clinical examination, sensibility tests, and digital periapical radiographs were also performed at successive time intervals. Statistical analysis was performed using the Student t test and Cochran test. The level of significance was set at P ≤ .05.
RESULTS


All 18 teeth were symptom free with healing of the periapical lesions. Regarding the SI measurements, there was no statistically significant difference between the SI of the normal contralateral teeth and that of the regenerated tissues in the treated teeth after a 12-month follow-up. In both groups, more than 60% of the cases regained pulp sensibility after 12 months.
CONCLUSIONS


Vital pulplike tissue could be successfully regenerated in mature teeth using REPs, which was not significantly affected by the size of the apical diameter. MRI could successfully assess this tissue in a quantitative, noninvasive manner.",2020,"CONCLUSIONS


Vital pulplike tissue could be successfully regenerated in mature teeth using REPs, which was not significantly affected by the size of the apical diameter.","['Eighteen maxillary anterior mature necrotic teeth with periapical lesions', 'Mature Teeth Using Magnetic Resonance Imaging']",['magnetic resonance imaging (MRI'],"['Clinical examination, sensibility tests, and digital periapical radiographs', 'symptom free with healing of the periapical lesions', 'signal intensity (SI', 'pulp sensibility', 'SI of the normal contralateral teeth']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0729269', 'cui_str': 'Periapical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0729269', 'cui_str': 'Periapical (qualifier value)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]",18.0,0.0497431,"CONCLUSIONS


Vital pulplike tissue could be successfully regenerated in mature teeth using REPs, which was not significantly affected by the size of the apical diameter.","[{'ForeName': 'Noha Mohamed', 'Initials': 'NM', 'LastName': 'El-Kateb', 'Affiliation': 'Conservative Department, Endodontic Division, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Electronic address: n_a572007@hotmail.com.'}, {'ForeName': 'Rania Noaman', 'Initials': 'RN', 'LastName': 'El-Backly', 'Affiliation': 'Conservative Department, Endodontic Division, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Wessam Mohamed', 'Initials': 'WM', 'LastName': 'Amin', 'Affiliation': 'Radiology and Medical Science Department, Faculty of Allied Science, Pharos University, Alexandria, Egypt.'}, {'ForeName': 'Amr Mohamed', 'Initials': 'AM', 'LastName': 'Abdalla', 'Affiliation': 'Conservative Department, Endodontic Division, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}]",Journal of endodontics,['10.1016/j.joen.2020.01.026']
96,32333159,The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study.,"INTRODUCTION


Music can have a positive effect on stress and general task performance. This randomized crossover study assessed the effects of preferred music on laparoscopic surgical performance in a simulated setting.
METHODS


Sixty medical students, inexperienced in laparoscopy, were included between June 2018 and November 2018. A randomized, 4-period, 4-sequence, 2-treatment crossover study design was used, with each participant acting as its own control. Participants performed four periods, consisting of five peg transfer tasks each period, on a laparoscopic box trainer: two periods while wearing active noise-cancelling headphones and two periods during music exposure. Participants were randomly allocated to a sequence determining the order of the four periods. The parameters time to task completion, path length and normalized jerk were assessed. Mental workload was assessed using the Surgical Task Load Index questionnaire. Also, heart rate and blood pressure were assessed.
RESULTS


Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music. Also, mental workload was significantly reduced during music [median difference, - 2.41 (interquartile range, - 7.17-1.83) p = 0.021)]. No statistically significant effect was observed on heart rate and blood pressure.
CONCLUSION


Listening to preferred music improves laparoscopic surgical performance and reduces mental workload in a simulated setting.
TRIAL REGISTRATION


Trial registration number: NCT04111679.",2020,"RESULTS


Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music.","['Sixty medical students, inexperienced in laparoscopy, were included between June 2018 and November 2018']","['Preferred Music', 'Listening to preferred music', 'laparoscopic box trainer: two periods while wearing active noise-cancelling headphones and two periods during music exposure']","['Surgical Task Load Index questionnaire', 'Laparoscopic Surgical Performance', 'Mental workload', 'parameters time to task completion, path length and normalized jerk', 'path length', 'mental workload', 'heart rate and blood pressure', 'laparoscopic surgical performance']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205544', 'cui_str': 'Canceled'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",60.0,0.444156,"RESULTS


Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music.","[{'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Oomens', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. pim.oomens@gmail.com.'}, {'ForeName': 'Victor X', 'Initials': 'VX', 'LastName': 'Fu', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Vincent E E', 'Initials': 'VEE', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}]",World journal of surgery,['10.1007/s00268-020-05523-0']
97,32313031,Resistance training preserves high-intensity interval training induced improvements in skeletal muscle capillarization of healthy old men: a randomized controlled trial.,"Skeletal muscle capillarization is a determining factor in gas and metabolite exchange, while its impairments may contribute to the development of sarcopenia. Studies on the potential of resistance training (RT) to induce angiogenesis in older muscles have been inconclusive, and effects of sequential endurance training (ET) and RT on capillarization are unknown. Healthy older men (66.5 ± 3.8 years) were engaged in either 12 weeks of habitual course observation (HC) followed by 12 weeks of RT (n = 8), or 12 weeks of high-intensity interval training (HIIT) followed by 12 weeks of RT (n = 9). At baseline, following 12 and 24 weeks, m. vastus lateralis biopsies were obtained. (Immuno-)histochemistry was used to assess indices of muscle fiber capillarization, muscle fiber morphology and succinate dehydrogenase (SDH) activity. Single periods of RT and HIIT resulted in similar improvements in capillarization and SDH activity. During RT following HIIT, improved capillarization and SDH activity, as well as muscle fiber morphology remained unchanged. The applied RT and HIIT protocols were thus similarly effective in enhancing capillarization and oxidative enzyme activity and RT effectively preserved HIIT-induced adaptations of these parameters. Hence, both, RT and HIIT, are valid training modalities for older men to improve skeletal muscle vascularization.",2020,"During RT following HIIT, improved capillarization and SDH activity, as well as muscle fiber morphology remained unchanged.","['Healthy older men (66.5\u2009±\u20093.8 years', 'older men', 'healthy old men', 'older muscles']","['Resistance training', 'habitual course observation (HC', 'resistance training (RT']","['muscle fiber capillarization, muscle fiber morphology and succinate dehydrogenase (SDH) activity', 'skeletal muscle capillarization', 'capillarization and SDH activity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0038615', 'cui_str': 'Succinate dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.02211,"During RT following HIIT, improved capillarization and SDH activity, as well as muscle fiber morphology remained unchanged.","[{'ForeName': 'Aurel B', 'Initials': 'AB', 'LastName': 'Leuchtmann', 'Affiliation': 'Institute of Translational Medicine ITM, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandro Manuel', 'Initials': 'SM', 'LastName': 'Mueller', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aguayo', 'Affiliation': 'Institute of Human Movement Sciences, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Petersen', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ligon-Auer', 'Affiliation': 'Institute of Human Movement Sciences, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Flück', 'Affiliation': 'Laboratory for Muscle Plasticity, Balgrist University Hospital, Department of Orthopaedics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Toigo', 'Affiliation': 'Institute of Human Movement Sciences, ETH Zurich, Zurich, Switzerland. marco.toigo@oym.ch.'}]",Scientific reports,['10.1038/s41598-020-63490-x']
98,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES


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


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


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


Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
99,31132346,Comparison of unintended pregnancy at 12 months between two contraceptive care programs; a controlled time-trend design.,"OBJECTIVES


To compare unintended pregnancy rates at 12 months between women receiving structured contraceptive counseling plus usual contraceptive care and women receiving structured contraceptive counseling, healthcare provider education and cost support for long-acting reversible contraceptive (LARC) methods.
STUDY DESIGN


Using a controlled time-trend study design, we first enrolled 502 women receiving structured contraceptive counseling in addition to usual care (""Enhanced Care"") and subsequently enrolled 506 women receiving counseling plus healthcare provider education and cost support for LARC methods (""Complete CHOICE"") at three federally qualified health centers (FQHCs). Cost support included funds to health centers for ""on-the-shelf"" LARC methods and no-cost LARC methods for uninsured women. Participants completed in-person baseline surveys and follow-up surveys by telephone at 3, 6 and 12 months. We used Kaplan-Meier survival function to estimate 12-month unintended pregnancy rates and Cox proportional-hazards regression to compare unintended pregnancy rates between the two groups. We imputed pregnancy outcomes for women lost to follow-up (9%) prior to 12 months.
RESULTS


""Complete CHOICE"" participants were less likely to report an unintended pregnancy at 12 months compared to ""Enhanced Care""; 5.3 vs. 9.8 pregnancies per 100 women-years (p=.01). After adjusting for confounders (recruitment site, race, age and federal poverty level), women in ""Complete CHOICE"" had a 40% lower risk of unintended pregnancy at 12 months (adjusted hazard ratio 0.60; 95% confidence interval 0.37-0.99).
CONCLUSIONS


Contraceptive provision that includes cost support and healthcare provider education in addition to patient counseling reduced unintended pregnancy at 12 months compared to counseling plus usual contraceptive care.
IMPLICATIONS


A program of contraceptive care that includes comprehensive counseling; healthcare provider education; cost support; and on-the-shelf, long-acting reversible contraception can reduce unintended pregnancy compared to contraceptive counseling in addition to usual health center care in the FQHC setting.",2019,"RESULTS


""Complete CHOICE"" participants were less likely to report an unintended pregnancy at 12 months compared to ""Enhanced Care""; 5.3 vs. 9.8 pregnancies per 100 women-years (p=.01).","['502 women receiving', '506 women receiving counseling plus healthcare provider education and cost support for LARC methods (""Complete CHOICE"") at three federally qualified health centers (FQHCs', 'women lost to follow-up (9%) prior to 12\u202fmonths', 'uninsured women', 'women receiving']","['structured contraceptive counseling plus usual contraceptive care and women receiving structured contraceptive counseling, healthcare provider education and cost support for long-acting reversible contraceptive (LARC) methods', 'structured contraceptive counseling in addition to usual care (""Enhanced Care']","['unintended pregnancy rates', 'risk of unintended pregnancy', 'unintended pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",506.0,0.13289,"RESULTS


""Complete CHOICE"" participants were less likely to report an unintended pregnancy at 12 months compared to ""Enhanced Care""; 5.3 vs. 9.8 pregnancies per 100 women-years (p=.01).","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Madden', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63108, USA. Electronic address: maddent@wustl.edu.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63108, USA.'}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Maddipati', 'Affiliation': 'Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63108, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Buckel', 'Affiliation': 'Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63108, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Goodman', 'Affiliation': 'College of Global Public Health, New York University, 715 Broadway, 10th Floor, New York, NY 10003, USA.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics and Gynecology, 550 University Blvd, University Hospital 2440, Indiana University School of Medicine, Indianapolis, IN 46202, USA.'}]",Contraception,['10.1016/j.contraception.2019.05.009']
100,32332810,A randomized controlled trial of motor imagery combined with structured progressive circuit class therapy on gait in stroke survivors.,"Structured Progressive Circuit Class Therapy (SPCCT) was developed based on task-oriented therapy, providing benefits to patients' motivation and motor function. Training with Motor Imagery (MI) alone can improve gait performance in stroke survivors, but a greater effect may be observed when combined with SPCCT. Health education (HE) is a basic component of stroke rehabilitation and can reduce depression and emotional distress. Thus, this study aimed to investigate the effect of MI with SPCCT against HE with SPCCT on gait in stroke survivors. Two hundred and ninety stroke survivors from 3 hospitals in Yangon, Myanmar enrolled in the study. Of these, 40 stroke survivors who passed the selection criteria were randomized into an experimental (n = 20) or control (n = 20) group. The experimental group received MI training whereas the control group received HE for 25 minutes prior to having the same 65 minutes SPCCT program, with both groups receiving training 3 times a week over 4 weeks. Temporo-spatial gait variables and lower limb muscle strength of the affected side were assessed at baseline, 2 weeks, and 4 weeks after intervention. After 4 weeks of training, the experimental group showed greater improvement than the control group in all temporospatial gait variables, except for the unaffected step length and step time symmetry which showed no difference. In addition, greater improvements of the affected hip flexor and knee extensor muscle strength were found in the experimental group. In conclusion, a combination of MI with SPCCT provided a greater therapeutic effect on gait and lower limb muscle strengths in stroke survivors.",2020,"In addition, greater improvements of the affected hip flexor and knee extensor muscle strength were found in the experimental group.","['stroke survivors', '40 stroke survivors who passed the selection criteria', 'Two hundred and ninety stroke survivors from 3 hospitals in Yangon, Myanmar enrolled in the study']","['MI training whereas the control group received HE for 25\u2009minutes prior to having the same 65\u2009minutes SPCCT program', 'Structured Progressive Circuit Class Therapy (SPCCT', 'MI with SPCCT against HE with SPCCT', 'motor imagery combined with structured progressive circuit class therapy', 'MI with SPCCT', 'Training with Motor Imagery (MI) alone']","['hip flexor and knee extensor muscle strength', 'temporospatial gait variables', 'Temporo-spatial gait variables and lower limb muscle strength', 'gait performance']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0411884,"In addition, greater improvements of the affected hip flexor and knee extensor muscle strength were found in the experimental group.","[{'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Bovonsunthonchai', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand. sunee.bov@mahidol.edu.'}, {'ForeName': 'Nilar', 'Initials': 'N', 'LastName': 'Aung', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Vimonwan', 'Initials': 'V', 'LastName': 'Hiengkaew', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Jarugool', 'Initials': 'J', 'LastName': 'Tretriluxana', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}]",Scientific reports,['10.1038/s41598-020-63914-8']
101,31855713,Improving gesture-based interaction between an assistive bathing robot and older adults via user training on the gestural commands.,"BACKGROUND


Gesture-based human-robot interaction (HRI) depends on the technical performance of the robot-integrated gesture recognition system (GRS) and on the gestural performance of the robot user, which has been shown to be rather low in older adults. Training of gestural commands (GCs) might improve the quality of older users' input for gesture-based HRI, which in turn may lead to an overall improved HRI.
OBJECTIVE


To evaluate the effects of a user training on gesture-based HRI between an assistive bathing robot and potential elderly robot users.
METHODS


Twenty-five older adults with bathing disability participated in this quasi-experimental, single-group, pre-/post-test study and underwent a specific user training (10-15 min) on GCs for HRI with the assistive bathing robot. Outcomes measured before and after training included participants' gestural performance assessed by a scoring method of an established test of gesture production (TULIA) and sensor-based gestural performance (SGP) scores derived from the GRS-recorded data, and robot's command recognition rate (CRR).
RESULTS


Gestural performance (TULIA = +57.1 ± 56.2 %, SGP scores = +41.1 ± 74.4 %) and CRR (+31.9 ± 51.2 %) significantly improved over training (p < .001). Improvements in gestural performance and CRR were highly associated with each other (r = 0.80-0.81, p < .001). Participants with lower initial gestural performance and higher gerontechnology anxiety benefited most from the training.
CONCLUSIONS


Our study highlights that training in gesture-based HRI with an assistive bathing robot is highly beneficial for the quality of older users' GCs, leading to higher CRRs of the robot-integrated GRS, and thus to an overall improved HRI.",2020,"Training of gestural commands (GCs) might improve the quality of older users' input for gesture-based HRI, which in turn may lead to an overall improved HRI.
","['Participants with lower initial gestural performance and higher gerontechnology anxiety benefited most from the training', 'older adults', 'Twenty-five older adults with bathing disability participated in this quasi-experimental, single-group, pre-/post-test study and underwent a']","['Training of gestural commands (GCs', 'Gesture-based human-robot interaction (HRI', 'user training', 'specific user training (10-15\u202fmin) on GCs for HRI with the assistive bathing robot']","[""participants' gestural performance assessed by a scoring method of an established test of gesture production (TULIA) and sensor-based gestural performance (SGP) scores derived from the GRS-recorded data, and robot's command recognition rate (CRR"", 'gestural performance and CRR', 'CRR']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0556286', 'cui_str': 'Bathing disability (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}]","[{'cui': 'C0036449', 'cui_str': 'Scoring Methods'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0033268'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}]",25.0,0.0222348,"Training of gestural commands (GCs) might improve the quality of older users' input for gesture-based HRI, which in turn may lead to an overall improved HRI.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Werner', 'Affiliation': 'Center for Geriatric Medicine, Heidelberg University, Heidelberg, Germany; Agaplesion Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Heidelberg, Germany. Electronic address: christian.werner@bethanien-heidelberg.de.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Kardaris', 'Affiliation': 'Institute of Communication and Computer Systems (ICCS), National Technical University of Athens, Athens, Greece. Electronic address: nkardaris@mail.ntua.gr.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Koutras', 'Affiliation': 'Institute of Communication and Computer Systems (ICCS), National Technical University of Athens, Athens, Greece. Electronic address: pkoutras@cs.ntua.gr.'}, {'ForeName': 'Athanasia', 'Initials': 'A', 'LastName': 'Zlatintsi', 'Affiliation': 'Institute of Communication and Computer Systems (ICCS), National Technical University of Athens, Athens, Greece. Electronic address: nzlat@cs.ntua.gr.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Maragos', 'Affiliation': 'Institute of Communication and Computer Systems (ICCS), National Technical University of Athens, Athens, Greece. Electronic address: maragos@cs.ntua.gr.'}, {'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Bauer', 'Affiliation': 'Center for Geriatric Medicine, Heidelberg University, Heidelberg, Germany; Agaplesion Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Heidelberg, Germany. Electronic address: juergen.bauer@bethanien-heidelberg.de.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hauer', 'Affiliation': 'Agaplesion Bethanien Hospital Heidelberg, Geriatric Center at the Heidelberg University, Heidelberg, Germany. Electronic address: khauer@bethanien-heidelberg.de.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2019.103996']
102,32151482,"Evaluation of the Amount of Root Canal Dentin Removed and Apical Transportation Occurrence after Instrumentation with ProTaper Next, OneShape, and EdgeFile Rotary Systems.","INTRODUCTION


The aim of this study was to evaluate the amount of root canal dentin removed and apical transportation occurrence after instrumentation of mesiobuccal canals of maxillary molars with ProTaper Next (PTN [Dentsply Maillefer, Ballaigues, Switzerland]), OneShape (OS [MicroMega, Besançon, France]), and EdgeFile (EF [Edge Endo, Albuquerque, NM]) rotary systems.
METHODS


Twenty-seven mesiobuccal canals of maxillary molars were used. Canals were randomly divided into 3 groups for canal preparation: PTN, EF X3, or OS (n = 9 for each group). Micro-computed tomographic imaging was used to measure apical transportation (mm) and the volume of dentin removed (mm 3 ). The amount of dentin removed was measured for the coronal portion and for the whole canal length. Superposition of pre- and postoperative cross-sectional apical slices were used to measure apical transportation at 1 mm from the apex; the differences were evaluated using the Kruskal-Wallis test and Wilcoxon analysis. The Spearman correlation coefficient was used to display the relationship between variables for each group. The significance level was set at P < .05.
RESULTS


The percentages of the amount of dentin removed on the coronal portion and the amount removed for the whole canal length were statistically similar between groups (P > .05). The average amount of apical transportation for the PTN, OS, and EF X3 were 0.197, 0.263, and 0.218 mm, respectively. Statistically, there were no significant differences between the 3 rotary instruments for apical transportation.
CONCLUSIONS


The amount of dentin removed for the coronal third portion and the whole canal length was similar for the PTN, OS, and EF X3 rotary instruments. Although there were differences in the sizes of apical enlargement, no apical transportation was observed in any of the instrumentation systems.",2020,"The amount of dentin removed for the coronal third portion and the whole canal length was similar for the PTN, OS, and EF X3 rotary instruments.",['Twenty-seven mesiobuccal canals of maxillary molars were used'],"['Micro-computed tomographic imaging', 'canal preparation: PTN, EF X3, or OS']","['sizes of apical enlargement, no apical transportation', 'amount of dentin removed on the coronal portion and the amount removed for the whole canal length']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",27.0,0.0316855,"The amount of dentin removed for the coronal third portion and the whole canal length was similar for the PTN, OS, and EF X3 rotary instruments.","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ankara University, Ankara, Turkey. Electronic address: dt.fndylmz@gmail.com.'}, {'ForeName': 'İrem', 'Initials': 'İ', 'LastName': 'Eren', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Eren', 'Affiliation': 'Department of Dentomaxillofacial Radiology, Faculty of Dentistry, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Mustafa A', 'Initials': 'MA', 'LastName': 'Badi', 'Affiliation': 'Division of Oral and Maxillofacial Radiology, Temple University, Kornberg School of Dentistry, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mert', 'Initials': 'M', 'LastName': 'Ocak', 'Affiliation': 'Department of Anatomy, Vocational school of Health, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Hakan Hamdi', 'Initials': 'HH', 'LastName': 'Çelik', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}]",Journal of endodontics,['10.1016/j.joen.2020.01.022']
103,32324615,Concentric and Eccentric Resistance Training Comparison on Physical Function and Functional Pain Outcomes in Knee Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the study was to compare the effectiveness of concentrically focused resistance training to eccentrically focused resistance training on physical function and functional pain in knee osteoarthritis.
DESIGN


This is a randomized, single-blinded controlled 4-mo trial. Older adults with knee osteoarthritis (N = 88; 68.3 ± 6.4 yrs, 30.4 ± 6.9 kg/m, and 67.4% women) were randomized to eccentrically focused resistance training, concentrically focused resistance training, or no-exercise control. Main outcomes included chair rise time, stair climb time, 6-min walk test distance, temporal-spatial parameters of gait, community ambulation, and functional pain.
RESULTS


Leg muscle strength improved in both training groups compared with no-exercise control. There were no significant group × time interactions for any functional performance score (chair rise time, stair climb time, 6-min walk test distance, gait parameters, community ambulation). Compared with no-exercise control, functional pain scores were reduced for chair rise (-38.6% concentrically focused resistance training, -50.3% eccentrically focused resistance training vs. +10.0%) and stair climb (-51.6% concentrically focused resistance training, -41.3% eccentrically focused resistance training vs. +80.7%; all P < 0.05). Pain scores were reduced during the 6-min walk and in early recovery with concentrically focused resistance training compared with the remaining two groups (P < 0.05).
CONCLUSIONS


Either resistance exercise type improves activity-related knee osteoarthritis pain, but concentrically focused resistance training more effectively reduced severity of ambulatory pain and pain upon walking cessation.",2020,"Pain scores were reduced during the six-minute walk and in early recovery with CNCRT compared to the remaining two groups (p<0.05).
","['knee osteoarthritis (OA', 'Knee Osteoarthritis', 'Older adults with knee OA (N=88; 68.3±6.4 yr, 30.4±6.9 kg/m and 67.4% women']","['resistance exercise type', 'concentrically-focused resistance training (CNCRT) to eccentrically-focused resistance training (ECCRT', 'ECCRT, CNCRT or no-exercise control (CON', 'Concentric and Eccentric Resistance Training Comparison']","['physical function and functional pain', 'ambulatory pain and pain upon walking cessation', 'CON, functional pain scores', 'Pain scores', 'functional performance score (chair rise time, stair climb time, six-minute walk test distance, gait parameters, community ambulation', 'Leg muscle strength', 'Physical Function and Functional Pain Outcomes', 'chair rise time, stair climb time, six-minute walk test distance, temporalspatial parameters of gait, community ambulation and functional pain', 'chair rise', 'stair climb', 'activity-related knee OA pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]",,0.0567988,"Pain scores were reduced during the six-minute walk and in early recovery with CNCRT compared to the remaining two groups (p<0.05).
","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Vincent', 'Affiliation': 'From the Divisions of Physical Medicine and Rehabilitation, Sports Medicine and Research, Department of Orthopaedics and Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Vincent', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001450']
104,32324634,Interprofessional Improv: Using Theater Techniques to Teach Health Professions Students Empathy in Teams.,"PROBLEM


Health professionals need to learn how to relate to one another to ensure high-quality patient care and to create collaborative and supportive teams in the clinical environment. One method for addressing both of these goals is teaching empathy during professional training to foster connection and commonality across differences. The authors describe a pilot improvisational theater (improv) course and present the preliminary outcomes showing its impact on interprofessional empathy.
APPROACH


In 2016-2017, the authors piloted a 15-hour course to teach interprofessional empathy to health professions students at the University of Wisconsin-Madison using improv techniques. The authors used a convergent mixed-methods design to evaluate the course's impact on interprofessional empathy. Students enrolled in the course (intervention group, n = 45) and a comparison group (n = 41) completed 2 validated empathy questionnaires (Interpersonal Reactivity Index [IRI], Consultative and Relational Empathy [CARE] measure) and a facial expression recognition task to measure empathy in the pre- and postintervention periods. Differences were examined using paired t tests. Semistructured interviews were conducted with 8 course participants to gain a deeper understanding of the course's effects.
OUTCOMES


The intervention group's mean scores on 5 CARE items improved significantly: ease, care, explain, help, and plan. On the IRI, personal distress levels decreased significantly in both the intervention and comparison groups. In the interviews, students who took the class reported a positive impact on their interprofessional relationships and on their ability to think on their feet. They also reported improv influenced other areas of their lives, including patient care and interactions with people outside their work life.
NEXT STEPS


The authors have continued to offer the course. They aim to conduct a randomized controlled study with medical students and test durability by measuring empathy again 3-6 months following the intervention.",2020,"On the IRI, personal distress levels decreased significantly in both the intervention and comparison groups.","['medical students', 'In 2016-2017 the authors piloted a 15-hour course to teach interprofessional empathy to health professions students at the University of Wisconsin-Madison using improv techniques', 'Interprofessional Improv: Using Theater Techniques to Teach Health Professions Students Empathy in Teams', 'Students enrolled in the course (intervention group, n = 45) and a comparison group (n = 41) completed 2']",[],"['IRI, personal distress levels', 'validated empathy questionnaires (Interpersonal Reactivity Index [IRI], Consultative and Relational Empathy [CARE] measure) and a facial expression recognition task to measure empathy', 'mean scores on 5 CARE items improved significantly: ease, care, explain, help, and plan']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0018722', 'cui_str': 'Health Professions'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0960740', 'cui_str': 'ImProv'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",[],"[{'cui': 'C0022077', 'cui_str': 'Iris structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",,0.0187709,"On the IRI, personal distress levels decreased significantly in both the intervention and comparison groups.","[{'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Zelenski', 'Affiliation': 'A.B. Zelenski is assistant professor and director of medical education, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. N. Saldivar is chair, Department of Theatre, University of Nevada, Las Vegas, and executive director, Nevada Conservatory Theatre, Las Vegas, Nevada. L.S. Park is a clinical research coordinator, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. V. Schoenleber is a project manager, Internal Medicine Residency Program, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. F. Osman is a biostatistician, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. S. Kraemer is founder and owner, Blueprint for Education, Madison, Wisconsin.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Saldivar', 'Affiliation': ''}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Vonnie', 'Initials': 'V', 'LastName': 'Schoenleber', 'Affiliation': ''}, {'ForeName': 'Fauzia', 'Initials': 'F', 'LastName': 'Osman', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kraemer', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003420']
105,32333847,"Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study.","BACKGROUND


Raxibacumab is a monoclonal antibody against protective antigen, which is the cell-binding part of Bacillus anthracis toxin, and is approved for treatment and postexposure prophylaxis of inhalational anthrax. Anthrax Vaccine Adsorbed (AVA), for anthrax prophylaxis, consists primarily of adsorbed protective antigen. We did a postapproval study to assess the effect of raxibacumab on immunogenicity of AVA.
METHODS


We did an open-label, parallel-group, randomised non-inferiority study at three centres in the USA. We enrolled healthy volunteers (aged 18-65 years) with no evidence of exposure to protective antigen. Participants were randomly allocated (1:1) according to a pregenerated balanced independent randomisation schedule to either subcutaneous 0·5 mL AVA on days 1, 15, and 29 or raxibacumab intravenous infusion (40 mg/kg) immediately before AVA on day 1, followed by AVA only on days 15 and 29. It was an open-label study to investigators and participants; however, the sponsor remained blinded during the study. The primary outcome was the ratio of geometric mean concentrations (GMCs) of anti-protective antigen antibodies (attributable to the immune response to AVA) between AVA and AVA plus raxibacumab 4 weeks after the first AVA dose in the per-protocol population. The per-protocol population comprised all individuals who received the allocated treatment within the protocol-specified visit window and completed the primary study outcome assessment, without a protocol deviation requiring exclusion. The non-inferiority margin for the ratio of GMCs was predefined (upper limit of 90% CI <1·5). This trial is registered with ClinicalTrials.gov, NCT02339155.
FINDINGS


Between Feb 24, 2015, and June 6, 2017, 873 participants were screened for eligibility, of whom 300 were excluded. 573 were randomly allocated either AVA (n=287) or AVA plus raxibacumab (n=286). The per-protocol population comprised 276 individuals assigned AVA and 269 allocated AVA plus raxibacumab. At week 4, the GMC of anti-protective antigen antibodies in participants allocated AVA was 26·5 μg/mL (95% CI 23·6-29·8) compared with 22·5 μg/mL (20·1-25·1) among individuals allocated AVA plus raxibacumab. The ratio between groups was 1·18 (90% CI 1·03-1·35; p=0·0019), which met the predefined non-inferiority margin. Adverse events in the safety population were similar across groups (87 [30%] of 286 in the AVA group vs 80 [29%] of 280 in the AVA plus raxibacumab group) and no treatment-related serious adverse events were reported.
INTERPRETATION


Co-administration of raxibacumab with AVA does not negatively affect AVA immunogenicity. This finding suggests that combining raxibacumab with AVA might provide added benefit in postexposure prophylaxis against inhalational anthrax.
FUNDING


US Biomedical Advanced Research and Development Authority, and GlaxoSmithKline.",2020,"Adverse events in the safety population were similar across groups (87 [30%] of 286 in the AVA group vs 80 [29%] of 280 in the AVA plus raxibacumab group) and no treatment-related serious adverse events were reported.
","['enrolled healthy volunteers (aged 18-65 years) with no evidence of exposure to protective antigen', '276 individuals assigned AVA and 269 allocated', '873 participants were screened for eligibility, of whom 300 were excluded', 'Between Feb 24, 2015, and June 6, 2017']","['AVA', 'AVA plus raxibacumab', 'raxibacumab intravenous infusion', 'Anthrax Vaccine Adsorbed (AVA', 'raxibacumab with AVA', 'subcutaneous 0·5 mL AVA', 'raxibacumab']","['AVA immunogenicity', 'ratio of geometric mean concentrations (GMCs) of anti-protective antigen antibodies', 'serious adverse events', 'Adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1443846', 'cui_str': 'Anthrax toxin protective antigen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0358297', 'cui_str': 'Anthrax vaccine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0358297', 'cui_str': 'Anthrax vaccine'}, {'cui': 'C1329979', 'cui_str': 'Anthrax Vaccine Adsorbed'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2717174', 'cui_str': 'raxibacumab'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1329979', 'cui_str': 'Anthrax Vaccine Adsorbed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1443846', 'cui_str': 'Anthrax toxin protective antigen'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",873.0,0.343685,"Adverse events in the safety population were similar across groups (87 [30%] of 286 in the AVA group vs 80 [29%] of 280 in the AVA plus raxibacumab group) and no treatment-related serious adverse events were reported.
","[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Skoura', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang-Jairaj', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Vijayalakshmi', 'Initials': 'V', 'LastName': 'Chandrasekaran', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Billiard', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Yeakey', 'Affiliation': 'GlaxoSmithKline, Rockville, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Smith', 'Affiliation': 'Alliance for Multispecialty Research at University of Tennessee Medical Center, Knoxville, TN, USA; New Orleans Center for Clinical Research, New Orleans, LA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Steel', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Lionel K', 'Initials': 'LK', 'LastName': 'Tan', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK. Electronic address: lionel.x.tan@gsk.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30069-4']
106,32334141,Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma.,"BACKGROUND


Blood eosinophil count (BEC) measurements are a noninvasive, relatively reliable surrogate marker for eosinophilic airway inflammation. Single measurements of peripheral BEC greater than or equal to 150 cells/μL predict the response to anti-eosinophil therapies for patients with characteristics of severe eosinophilic asthma.
OBJECTIVE


To describe how BECs shift over time for patients with severe, uncontrolled asthma receiving placebo in 2 large, randomized, placebo-controlled clinical trials of benralizumab (SIROCCO and CALIMA).
METHODS


Our analysis included all adult patients who were randomized to placebo in the SIROCCO and CALIMA phase III benralizumab studies. Patients were categorized into baseline BEC groups of less than 150 cells/μL, greater than or equal to 150 cells/μL but less than 300 cells/μL, and greater than or equal to 300 cells/μL. The timing of the initial shift from baseline to a different group was evaluated at weeks 4, 8, 24, and 40 and at the end of treatment. Baseline characteristics, including oral corticosteroid use, were described based on the presence or absence of a BEC group shift.
RESULTS


Of the 734 evaluable patients, 65% (n = 474) shifted BEC groups during the study, and most patients (86% [n = 410]) shifted by week 24. Patients who started in the less than 150 cells/μL group tended to shift groups earlier, with 59% shifting by week 4 compared with 38% to 55% for other groups in the same time frame. Patients who shifted BEC groups vs those who did not tend to have lower BECs, more oral corticosteroid use, and less incidence of nasal polyps or past polypectomy.
CONCLUSION


A single BEC measurement, particularly when low, may be inadequate to help establish a phenotype of severe eosinophilic asthma.
TRIAL REGISTRATION


ClinicalTrials.gov Identifiers NCT01928771 (SIROCCO trial) and NCT01914757 (CALIMA trial).",2020,"Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
","['patients with severe, uncontrolled asthma receiving', 'patients with characteristics of severe eosinophilic asthma', '734 evaluable patients, 65% (n=474) shifted blood eosinophil count groups during the study, and the majority (86% [n=410]) shifted by Week 24']",['placebo'],"['incidence of nasal polyps/past polypectomy', 'blood eosinophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}]",734.0,0.0497634,"Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
","[{'ForeName': 'Njira L', 'Initials': 'NL', 'LastName': 'Lugogo', 'Affiliation': 'University of Michigan Medical Center, Ann Arbor, Michigan. Electronic address: nlugogo@med.umich.edu.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Kreindler', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hirsch', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Trudo', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.011']
107,31912801,Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials.,"BACKGROUND


The phase II J003 (N = 169) and phase III RECOURSE (N = 800) trials demonstrated a significant improvement in survival with trifluridine (FTD)/tipiracil (TPI) versus placebo in patients with refractory metastatic colorectal cancer. This post hoc analysis investigated pharmacokinetic data of FTD/TPI exposure and pharmacodynamic markers, such as chemotherapy-induced neutropenia (CIN) and clinical outcomes.
PATIENTS AND METHODS


A total of 210 patients from RECOURSE were enrolled in this substudy. A limited sampling approach was used, with three pharmacokinetic samples drawn on day 12 of cycle 1. Patients were categorized as being above or below the median area under the plasma concentration-time curve (AUC) for FTD and TPI. We conducted a post hoc analysis using the entire RECOURSE population to determine the correlations between CIN and clinical outcome. We then carried out a similar analysis on the J003 trial to validate the results.
RESULTS


In the RECOURSE subset, patients in the high FTD AUC group had a significantly increased CIN risk. Analyses of the entire population demonstrated that FTD/TPI-treated patients with CIN of any grade in cycles 1 and 2 had significantly longer median overall survival (OS) and progression-free survival (PFS) than patients who did not develop CIN and patients in the placebo group. Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN. Similar results were obtained in the J003 cohort.
CONCLUSIONS


In RECOURSE, patients with higher FTD drug exposure had an increased CIN risk. FTD/TPI-treated patients who developed CIN had improved OS and PFS versus those in the placebo group and those who did not develop CIN. Similar findings were reported in the J003 cohort, thus validating the RECOURSE results. The occurrence of CIN may be a useful predictor of treatment outcomes for FTD/TPI-treated patients. CLINICALTRIALS.
GOV IDENTIFIER


NCT01607957 (RECOURSE).
JAPAN PHARMACEUTICAL INFORMATION CENTER NUMBER


JapicCTI-090880 (J003).",2020,Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN.,"['A total of 210 patients from RECOURSE were enrolled in this substudy', 'patients with refractory metastatic colorectal cancer', 'metastatic colorectal cancer patients treated with']","['placebo', 'trifluridine/tipiracil', 'trifluridine (FTD)/tipiracil (TPI) versus placebo']","['CIN risk', 'OS and PFS', 'Neutropenia and survival outcomes', 'survival', 'median overall survival (OS) and progression-free survival (PFS', 'plasma concentration-time curve (AUC) for FTD and TPI']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",210.0,0.256832,Patients who required an FTD/TPI treatment delay had increased OS and PFS versus those in the placebo group and those who did not develop CIN.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: tyoshino@east.ncc.go.jp.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Division of Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garcia-Carbonero', 'Affiliation': 'Oncology Department, University Hospital 12 de Octubre, IIS imas12, UCM, CNIO, CIBERONC, Madrid, Spain.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cancer Chemotherapy, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""University Hospital Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Kochi Health Sciences Center, Kochi, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Department of Oncology, IRCCS AOU San Martino IST, Genoa, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; Division of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Department of Oncology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Department of Oncology, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Clinical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, KKR Sapporo Medical Center Tonan Hospital, Sapporo, Japan.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Department of Gastrointestinal Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tran', 'Affiliation': 'Department of Medical Oncology, The Royal Melbourne Hospital, Victoria, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hamada', 'Affiliation': 'Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tanase', 'Affiliation': 'Department of Data Science, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Department of Clinical Development, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Makris', 'Affiliation': 'Statistical Consultant, Stathmi, Inc., New Hope, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Yamashita', 'Affiliation': 'Department of Bioanalytics and Drug Metabolism and Pharmacokinetics, Taiho Oncology, Inc., Princeton, USA.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2019.10.005']
108,32171564,Micro-Computed Tomographic Evaluation of Canal Transportation and Centering Ability of 4 Heat-Treated Nickel-Titanium Systems.,"INTRODUCTION


This study aimed to evaluate and compare canal transportation and centering ability of 4 different root canal preparation systems produced with thermal treatments by means of micro-computed tomographic imaging.
METHODS


Eighty mesial canals of human extracted mandibular molars were selected based on similar morphologic parameters and were randomly assigned to 4 experimental groups (n = 20) according to the canal instrumentation technique: HyFlex CM (HCM [Coltène-Whaledent, Allstätten, Switzerland]), HyFlex EDM (HEDM [Coltène-Whaledent]), WaveOne Gold (WOG [Dentsply Sirona, Ballaigues, Switzerland]), and OneCurve (OC [Micro-Mega, Besancon, France]). The specimens were scanned before and after root canal preparation using X-ray micro-computed tomographic imaging at a resolution of 19.9 μm. Apical transportation and centering ability were then analyzed at 3 different levels: 3 mm, 5 mm, and 7 mm from the apex, representing the apical, midroot, and coronal thirds of the root, respectively. One-way analysis of variance and Kruskal-Wallis tests were used to statistically compare the groups. The significance level was set at 5%.
RESULTS


HCM caused less canal transportation than WOG at the 3-mm level in both the buccal and lingual canals (P < .05). Also, HCM resulted in less canal transportation than WOG and OC at the 7-mm level regarding lingual canals. No statistically significant differences were recorded between the groups when the mean centering ratios were compared.
CONCLUSIONS


The 4 evaluated systems safely prepared root canals causing minimal canal transportation and producing relatively centered preparations. In terms of canal transportation, HCM performed better than WOG at the apical level and better than WOG and OC at the coronal level.",2020,"RESULTS


HCM caused less canal transportation than WOG at the 3-mm level in both the buccal and lingual canals (P < .05).",['Eighty mesial canals of human extracted mandibular molars were selected based on similar morphologic parameters'],"['4 Heat-Treated Nickel-Titanium Systems', 'canal instrumentation technique: HyFlex CM (HCM [Coltène-Whaledent, Allstätten, Switzerland]), HyFlex EDM (HEDM [Coltène-Whaledent]), WaveOne Gold (WOG [Dentsply Sirona, Ballaigues, Switzerland', 'HCM']","['canal transportation', 'Apical transportation and centering ability', 'mean centering ratios']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0549183', 'cui_str': 'Midline (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}]","[{'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",80.0,0.0358585,"RESULTS


HCM caused less canal transportation than WOG at the 3-mm level in both the buccal and lingual canals (P < .05).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Razcha', 'Affiliation': 'Department of Endodontology, School of Dentistry, Aristotle University of Thessaloniki, Thessaloniki, Greece. Electronic address: christinarazcha@gmail.com.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Zacharopoulos', 'Affiliation': 'Institute of Electronic Structure and Laser, Foundation for Research and Technology-Hellas, Heraklion, Crete, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Anestis', 'Affiliation': 'Institute of Electronic Structure and Laser, Foundation for Research and Technology-Hellas, Heraklion, Crete, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Mikrogeorgis', 'Affiliation': 'Department of Endodontology, School of Dentistry, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Giannis', 'Initials': 'G', 'LastName': 'Zacharakis', 'Affiliation': 'Institute of Electronic Structure and Laser, Foundation for Research and Technology-Hellas, Heraklion, Crete, Greece.'}, {'ForeName': 'Kleoniki', 'Initials': 'K', 'LastName': 'Lyroudia', 'Affiliation': 'Department of Endodontology, School of Dentistry, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of endodontics,['10.1016/j.joen.2020.01.020']
109,32317700,"Neck-specific exercise for radiating pain and neurological deficits in chronic whiplash, a 1-year follow-up of a randomised clinical trial.","Up to 90% of people with neurological deficits following whiplash injury report chronic symptoms. A recent unique study of neck-specific exercise showed positive results (post-intervention at 12 weeks), regarding arm pain and neurological deficits in people with chronic whiplash associated disorders (WAD). This 1-year follow-up of that randomised controlled study with assessor blinding aimed to examine whether neck-specific exercise with (NSEB) or without (NSE) a behavioural approach has long-term benefits over physical activity prescription (PPA) regarding arm pain and neurological deficits (n = 171). Interventions were: NSE, NSEB, or PPA. Follow-up of arm pain, paraesthesia bothersomeness (questionnaires) and clinical neurological tests were performed after 3, 6 and 12 months and analysed with Linear Mixed Models and General Estimating Equations. The NSE and/or NSEB groups reported significantly less pain and paraesthesia bothersomeness as well as higher odds of normal key muscle arm strength and of normal upper limb neural tension over the year (all p < 0.03), compared with PPA. In conclusion, results suggest that neck-specific exercise with or without a behavioural approach may have persisting long term benefits over PPA regarding arm pain and clinical signs associated with neurological deficits in chronic WAD.",2020,"The NSE and/or NSEB groups reported significantly less pain and paraesthesia bothersomeness as well as higher odds of normal key muscle arm strength and of normal upper limb neural tension over the year (all p < 0.03), compared with PPA.",['people with chronic whiplash associated disorders (WAD'],"['neck-specific exercise with (NSEB) or without (NSE', 'neck-specific exercise', 'Neck-specific exercise']","['Follow-up of arm pain, paraesthesia bothersomeness (questionnaires) and clinical neurological tests', 'pain and paraesthesia bothersomeness', 'normal key muscle arm strength and of normal upper limb neural tension']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C1292726', 'cui_str': 'Associated disorder'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",,0.0665411,"The NSE and/or NSEB groups reported significantly less pain and paraesthesia bothersomeness as well as higher odds of normal key muscle arm strength and of normal upper limb neural tension over the year (all p < 0.03), compared with PPA.","[{'ForeName': 'Maria Landén', 'Initials': 'ML', 'LastName': 'Ludvigsson', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Division of Prevention Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, Linköping, Sweden. Maria.Landen.Ludvigsson@liu.se.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Peterson', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Division of Prevention Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': 'Department of Health Medicine and Caring Sciences, Division of Prevention Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-020-62722-4']
110,31939849,Postoperative Pain and Analgesic Requirements in the First Year after Intraoperative Methadone for Complex Spine and Cardiac Surgery.,"BACKGROUND


Methadone is a long-acting opioid that has been reported to reduce postoperative pain scores and analgesic requirements and may attenuate development of chronic postsurgical pain. The aim of this secondary analysis of two previous trials was to follow up with patients who had received a single intraoperative dose of either methadone or traditional opioids for complex spine or cardiac surgical procedures.
METHODS


Preplanned analyses of long-term outcomes were conducted for spinal surgery patients randomized to receive 0.2 mg/kg methadone at the start of surgery or 2 mg hydromorphone at surgical closure, and for cardiac surgery patients randomized to receive 0.3 mg/kg methadone or 12 μg/kg fentanyl intraoperatively. A pain questionnaire assessing the weekly frequency (the primary outcome) and intensity of pain was mailed to subjects 1, 3, 6, and 12 months after surgery. Ordinal data were compared with the Mann-Whitney U test, and nominal data were compared using the chi-square test or Fisher exact probability test. The criterion for rejection of the null hypothesis was P < 0.01.
RESULTS


Three months after surgery, patients randomized to receive methadone for spine procedures reported the weekly frequency of chronic pain was less (median score 0 on a 0 to 4 scale [less than once a week] vs. 3 [daily] in the hydromorphone group, P = 0.004). Patients randomized to receive methadone for cardiac surgery reported the frequency of postsurgical pain was less at 1 month (median score 0) than it was in patients randomized to receive fentanyl (median score 2 [twice per week], P = 0.004).
CONCLUSIONS


Analgesic benefits of a single dose of intraoperative methadone were observed during the first 3 months after spinal surgery (but not at 6 and 12 months), and during the first month after cardiac surgery, when the intensity and frequency of pain were the greatest.",2020,"Patients randomized to receive methadone for cardiac surgery reported the frequency of postsurgical pain was less at 1 month (median score 0) than it was in patients randomized to receive fentanyl (median score 2 [twice per week], P = 0.004).
","['patients who had received a single intraoperative dose of either', 'for complex spine or cardiac surgical procedures']","['hydromorphone', 'fentanyl', 'methadone or 12 μg/kg fentanyl intraoperatively', 'methadone or traditional opioids', 'methadone', 'Methadone']","['intensity of pain', 'weekly frequency of chronic pain', 'frequency of postsurgical pain', 'Postoperative Pain and Analgesic Requirements', 'intensity and frequency of pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0018821', 'cui_str': 'Surgical Procedures, Heart'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.218647,"Patients randomized to receive methadone for cardiac surgery reported the frequency of postsurgical pain was less at 1 month (median score 0) than it was in patients randomized to receive fentanyl (median score 2 [twice per week], P = 0.004).
","[{'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Murphy', 'Affiliation': 'From the Department of Anesthesiology, NorthShore University HealthSystem, University of Chicago Pritzker School of Medicine, Evanston, Illinois (G.S.M., S.B.G., T.D.S., M.A.D., D.D., S.B., J.B., C.E.M., G.J.T., K.J.T., J.W.S.) the Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (M.J.A.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Avram', 'Affiliation': ''}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Greenberg', 'Affiliation': ''}, {'ForeName': 'Torin D', 'Initials': 'TD', 'LastName': 'Shear', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Deshur', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bilimoria', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Benson', 'Affiliation': ''}, {'ForeName': 'Colleen E', 'Initials': 'CE', 'LastName': 'Maher', 'Affiliation': ''}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Trenk', 'Affiliation': ''}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Teister', 'Affiliation': ''}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Szokol', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003025']
111,32325164,Perineural Dextrose and Corticosteroid Injections for Ulnar Neuropathy at the Elbow: A Randomized Double-blind Trial.,"OBJECTIVE


To assess the effects of perineural corticosteroid and 5% dextrose water (D5W) injections in patients with mild to moderate ulnar neuropathy at the elbow (UNE).
DESIGN


Prospective, randomized, double-blind, controlled trial (6-month follow-up).
SETTING


Outpatients of local medical center settings.
PARTICIPANTS


Patients (N=36) with mild to moderate UNE were randomized, and 33 participants were included in the final data analysis.
INTERVENTIONS


Patients were administered a single perineural injection with 5 mL D5W and 3 mL corticosteroid (triamcinolone acetonide, 10mg/mL) mixed with 2 mL normal saline under ultrasound guidance in the dextrose and steroid groups, respectively.
MAIN OUTCOME MEASURES


The visual analog scale digital pain or paresthesia/dysesthesia score was the primary outcome. The secondary outcomes were the Disabilities of the Arm, Shoulder, and Hand questionnaire, motor nerve conduction velocity, and cross-sectional area (CSA) of the ulnar nerve. The measurement assessment was conducted before and 1, 3, 4, and 6 months after injection.
RESULTS


Thirty-three patients completed the study. Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the third month onward.
CONCLUSIONS


We suggest D5W as a more suitable injectate for perineural injection in patients with UNE.",2020,"Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the 3 rd  month onward.
","['ulnar neuropathy at the elbow', 'Outpatients of local medical center settings', 'Thirty-six patients with mild-to-moderate UNE were randomized and 33 participants were included in the final data analysis', 'patients with mild-to-moderate ulnar neuropathy at the elbow (UNE', 'Thirty-three patients completed the study']","['perineural corticosteroid and 5% dextrose water', 'Perineural dextrose and corticosteroid injections', 'single perineural injection with 5 mL D5W and 3 mL corticosteroid (10 mg/mL) mixed with 2 mL normal saline under ultrasound guidance in the dextrose and steroid groups, respectively']","['symptom severity and CSA of the ulnar nerve', 'dysesthesia score', 'Disabilities of the Arm, Shoulder, and Hand questionnaire, motor nerve conduction velocity, and cross-sectional area (CSA) of the ulnar nerve', 'visual analog scale digital pain or paresthesia']","[{'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}, {'cui': 'C0241057', 'cui_str': 'Burning sensation of skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0457379', 'cui_str': 'Motor nerve conduction velocity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",36.0,0.570527,"Both injections were found to be equally effective at most measurement points, although the dextrose group experienced larger reductions in symptom severity and CSA of the ulnar nerve from the 3 rd  month onward.
","[{'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Department of Physical Medicine and Rehabilitation, Taichung Armed Forces General Hospital, Taichung City, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Su', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Ying', 'Initials': 'TY', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Integrated Pain Management Center, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Chia-Kuang', 'Initials': 'CK', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurology, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Graduate Institute of Medical Science, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yung-Tsan', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China; Integrated Pain Management Center, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China. Electronic address: crwu98@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.016']
112,31643041,Effect of Simvastatin on Permeability in Cerebral Cavernous Malformation Type 1 Patients: Results from a Pilot Small Randomized Controlled Clinical Trial.,,2020,,['Cerebral Cavernous Malformation Type 1 Patients'],['Simvastatin'],[],"[{'cui': 'C2919945', 'cui_str': 'Familial Cavernous Malformation'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]",[],,0.177976,,"[{'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Mabray', 'Affiliation': 'Department of Radiology, University of New Mexico Health Sciences Center, University of New Mexico, MSC 10 5530, 1 University of New Mexico, Albuquerque, NM, 87131, USA. mamabray@salud.unm.edu.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Caprihan', 'Affiliation': 'Mind Research Network, Albuquerque, NM, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Blaine L', 'Initials': 'BL', 'LastName': 'Hart', 'Affiliation': 'Department of Radiology, University of New Mexico Health Sciences Center, University of New Mexico, MSC 10 5530, 1 University of New Mexico, Albuquerque, NM, 87131, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Department of Neurology, University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM, USA.'}]",Translational stroke research,['10.1007/s12975-019-00737-4']
113,32201062,The use of leukocyte- and platelet-rich fibrin in the management of soft tissue healing and pain in post-extraction sockets: A randomized clinical trial.,"This study aimed to evaluate the clinical effect of leukocyte- and platelet-rich fibrin (L-PRF) to improve epithelialization and decrease postoperative pain in post-extraction sockets. Thirty two participants requiring extractions of posterior teeth were randomized into two groups: 1) extractions and socket filling with L-PRF membrane (test group) and 2) extraction with spontaneous healing (control group). One week after extraction, an assessment of soft tissue healing around the sockets was performed using the healing index. Also, postoperative pain by visual analog scale (VAS) and number of consumed analgesic tablets were recorded. In the first week, the sockets of the test group presented a significantly (mean of 3.81 ± 0.54; p = 0.0138) higher level of healing when compared to the sockets of the control group (mean of 3.18 ± 0.65). The participants of control group reported a significantly (mean of 5.12 ± 1.08; p = 0.0128) higher level of postoperative pain when compared to the test group (mean of 4 ± 1.15). Also, the control group consumed a greater number of analgesics (mean of 1.75 ± 0.85; p = 0.0136) when compared to the test group (mean of 1 ± 1.15). The results of the present study demonstrate that whenever improved healing of the extraction socket is needed, the use of L-PRF should be considered. In addition, the use of L-PRF decreases postoperative pain and discomfort.",2020,"Also, the control group consumed a greater number of analgesics (mean of 1.75 ± 0.85; p = 0.0136) when compared to the test group (mean of 1 ± 1.15).","['soft tissue healing and pain in post-extraction sockets', 'post-extraction sockets', 'Thirty two participants requiring extractions of posterior teeth']","['leukocyte- and platelet-rich fibrin (L-PRF', 'L-PRF', 'extractions and socket filling with L-PRF membrane (test group) and 2) extraction with spontaneous healing (control group', 'leukocyte- and platelet-rich fibrin']","['level of healing', 'number of analgesics', 'postoperative pain and discomfort', 'postoperative pain by visual analog scale (VAS) and number of consumed analgesic tablets', 'level of postoperative pain']","[{'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]",32.0,0.0272759,"Also, the control group consumed a greater number of analgesics (mean of 1.75 ± 0.85; p = 0.0136) when compared to the test group (mean of 1 ± 1.15).","[{'ForeName': 'Carlos Fernando', 'Initials': 'CF', 'LastName': 'de Almeida Barros Mourão', 'Affiliation': 'Department of Oral Surgery, School of Dentistry, Fluminense Federal University, Rio de Janeiro, Brazil; South Bay Dental Institute, Los Angeles, CA, United States.'}, {'ForeName': 'Rafael Coutinho', 'Initials': 'RC', 'LastName': 'de Mello-Machado', 'Affiliation': 'Department of Oral Surgery, School of Dentistry, Fluminense Federal University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Javid', 'Affiliation': 'South Bay Dental Institute, Los Angeles, CA, United States.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Moraschini', 'Affiliation': 'Department of Oral Surgery, School of Dentistry, Fluminense Federal University, Rio de Janeiro, Brazil. Electronic address: vitt.mf@gmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.02.020']
114,32151918,A 12-week exercise program for patients with hip osteoarthritis has no influence on gait parameters: A secondary analysis of a randomized controlled trial.,"BACKGROUND


Hip osteoarthritis is a major musculoskeletal disorder in the elderly. Evidence is given for the efficacy of exercise interventions in terms of self-reported physical functioning and pain. However, it has not yet been fully examined whether exercises influence gait.
RESEARCH QUESTION


The purpose of this RCT therefore was to evaluate effects of a 12-week exercise program on kinematic gait variables in subjects with hip osteoarthritis.
METHODS


210 participants were randomly assigned to exercise, non-treated control, or placebo ultrasound groups. The 12-week exercise intervention combined a weekly group session with home-based exercises (2/week), which entailed exercises for motor learning, flexibility, strengthening, and balance. Placebo ultrasound was given once a week. A 6-camera motion capture system was used for data collection. Data were derived from shod walking at self-selected speeds. Spatio-temporal and hip and knee joint angles of the stance phase were calculated. Data were averaged across five trials. Measurements were taken prior to and immediately after the intervention period. ANOVA/Kruskall-Wallis-Tests were used to analyze between-group effects for differences between test days. Pairwise comparisons were subsequently conducted in case of significant model effects. Data were analyzed per protocol (n = 185).
RESULTS


No statistically significant differences were detected for any of the outcome measures.
SIGNIFICANCE


Although hip muscle strength and gait quality are related, strength training of the hip-surrounding musculature without specific gait training elements cannot improve spatio-temporal gait characteristics or hip and knee joint angles in subjects with mild to moderate hip osteoarthritis. If gait should explicitly be improved through exercise, interventions must incorporate a relevant portion of gait-related tasks.",2020,"No statistically significant differences were detected for any of the outcome measures.
","['subjects with mild to moderate hip osteoarthritis', 'subjects with hip osteoarthritis', 'patients with hip osteoarthritis', '210 participants']","['exercise program', 'exercise interventions', 'Placebo ultrasound', 'exercise intervention combined a weekly group session with home-based exercises (2/week), which entailed exercises for motor learning, flexibility, strengthening, and balance', 'exercise, non-treated control, or placebo ultrasound groups']","['gait parameters', 'kinematic gait variables']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029410', 'cui_str': 'Coxarthrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",210.0,0.0445833,"No statistically significant differences were detected for any of the outcome measures.
","[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Krauss', 'Affiliation': 'Medical Clinic, Department of Sports Medicine, University of Tuebingen, Germany; Interfaculty Research Institute for Sports and Physical Activity Tuebingen, Department of Sports Medicine, University Hospital Tuebingen, Germany. Electronic address: inga.krauss@med.uni-tuebingen.de.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hein', 'Affiliation': 'Analyz3d, Basel, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Steinhilber', 'Affiliation': 'Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tuebingen, Germany.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Janßen', 'Affiliation': 'Medical Clinic, Department of Sports Medicine, University of Tuebingen, Germany; Interfaculty Research Institute for Sports and Physical Activity Tuebingen, Department of Sports Medicine, University Hospital Tuebingen, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.03.001']
115,32270927,Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study.,"OBJECTIVE


In contrast to intentionally restricting energy intake, restricting the eating window may be an option for treating obesity. By comparing time-restricted eating (TRE) with an unrestricted (non-TRE) control, it was hypothesized that TRE facilitates weight loss, alters body composition, and improves metabolic measures.
METHODS


Participants (17 women and 3 men; mean [SD]: 45.5 [12.1] years; BMI 34.1 [7.5] kg/m 2  ) with a prolonged eating window (15.4 [0.9] hours) were randomized to TRE (n = 11: 8-hour window, unrestricted eating within window) versus non-TRE (n = 9: unrestricted eating) for 12 weeks. Weight, body composition (dual x-ray absorptiometry), lipids, blood pressure, 2-hour oral glucose tolerance, 2-week continuous glucose monitoring, and 2-week physical activity (actigraphy assessed) were measured during the pre- and end-intervention periods.
RESULTS


The TRE group significantly reduced the eating window (end-intervention window: 9.9 [2.0] hours) compared with the non-TRE group (end-intervention window: 15.1 [1.1] hours) (P < 0.01). Compared with non-TRE, TRE decreased the number of eating occasions, weight, lean mass, and visceral fat (all P ≤ 0.05). Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05). Physical activity and metabolic measures remained unchanged.
CONCLUSIONS


In the setting of a randomized trial, TRE presents a simplified view of food intake that reduces weight.",2020,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","['Participants (17 women and 3 men; mean [SD]: 45.5 [12.1] years; BMI 34.1 [7.5] kg/m 2  ) with a prolonged eating window (15.4 [0.9] hours', 'Humans with Overweight']","['TRE', 'TRE (n\u2009=\u200911: 8-hour window, unrestricted eating within window) versus non-TRE']","['reduced weight', 'weight loss, alters body composition, and improves metabolic measures', 'visceral fat', 'number of eating occasions, weight, lean mass, and visceral fat', 'number of eating occasions', 'fat mass', 'Body Composition and Metabolic Measures', 'Weight, body composition (dual x-ray absorptiometry), lipids, blood pressure, 2-hour oral glucose tolerance, 2-week continuous glucose monitoring, and 2-week physical activity (actigraphy assessed', 'lean mass', 'eating window', 'Physical activity and metabolic measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]",17.0,0.0340305,"Compared with preintervention measures, the TRE group reduced the number of eating occasions (-21.9% [30.1%]) and reduced weight (-3.7% [1.8%]), fat mass (-4% [2.9%]), lean mass (-3.0% [2.7%]), and visceral fat (-11.1% [13.4%]) (all P ≤ 0.05).","[{'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Chow', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Emily N C', 'Initials': 'ENC', 'LastName': 'Manoogian', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Alvear', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Fleischer', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Honoree', 'Initials': 'H', 'LastName': 'Thor', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Dietsche', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Hodges', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Esch', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Malaeb', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Tasma', 'Initials': 'T', 'LastName': 'Harindhanavudhi', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'K Sreekumaran', 'Initials': 'KS', 'LastName': 'Nair', 'Affiliation': 'Division of Endocrinology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.'}, {'ForeName': 'Satchidananda', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Salk Institute for Biological Studies, La Jolla, California, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Mashek', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, University of Minnesota, Minneapolis, Minnesota, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22756']
116,32144895,"Baseline Habitual Physical Activity Predicts Weight Loss, Weight Compensation, and Energy Intake During Aerobic Exercise.","OBJECTIVE


This study aimed to determine whether different measures of habitual physical activity (PA) at baseline predict weight change, weight compensation, and changes in energy intake (EI) during a 24-week supervised aerobic exercise intervention.
METHODS


Data from 108 participants (78 women; 48.7 [SD: 11.6] years; BMI 31.4 [SD: 4.6] kg/m 2  ), randomly assigned to either the moderate-dose exercise group (8 kcal/kg of body weight per week) or the high-dose exercise group (20 kcal/kg of body weight per week) of the Examination of Mechanisms of Exercise-induced Weight Compensation (E-MECHANIC) trial, were analyzed. Moderate-to-vigorous PA (MVPA), steps per day, and PA energy expenditure (PAEE) were measured with SenseWear armbands (BodyMedia, Pittsburgh, Pennsylvania), and total activity energy expenditure and EI were estimated with doubly labeled water, all over 2 weeks, before and toward the end of the intervention. Multiple linear regression models, adjusted for sex, exercise group, and baseline value of the outcome, were used.
RESULTS


Baseline habitual MVPA levels predicted weight change (β = -0.275; P = 0.020), weight compensation (β = -0.238; P = 0.043), and change in EI (β = -0.318; P = 0.001). Associations between baseline PAEE and outcomes were comparable, whereas steps per day and, importantly, total activity energy expenditure (via doubly labeled water) did not significantly predict change in weight-related outcomes.
CONCLUSIONS


While acknowledging substantial variability in the data, on average, lower baseline habitual MVPA and PAEE levels were associated with less weight loss from exercise, higher compensation, and increased EI.",2020,"RESULTS


Baseline habitual MVPA levels predicted weight change (β = -0.275; P = 0.020), weight compensation (β ",['Data from 108 participants (78 women; 48.7 [SD: 11.6] years; BMI\xa031.4'],['supervised aerobic exercise intervention'],"['Moderate-to-vigorous PA (MVPA), steps per day, and PA energy expenditure (PAEE', 'habitual physical activity (PA', 'baseline habitual MVPA and PAEE levels', 'total activity energy expenditure', 'weight loss from exercise, higher compensation, and increased EI', 'weight compensation (β', 'SenseWear armbands (BodyMedia, Pittsburgh, Pennsylvania), and total activity energy expenditure and EI', 'Baseline Habitual Physical Activity Predicts Weight Loss, Weight Compensation, and Energy Intake', 'weight change, weight compensation, and changes in energy intake (EI']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",108.0,0.0856458,"RESULTS


Baseline habitual MVPA levels predicted weight change (β = -0.275; P = 0.020), weight compensation (β ","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Höchsmann', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22766']
117,31658115,Fresh Frozen Plasma versus Crystalloid Priming of Cardiopulmonary Bypass Circuit in Pediatric Surgery: A Randomized Clinical Trial.,"BACKGROUND


In congenital cardiac surgery, priming cardiopulmonary bypass (CPB) with fresh frozen plasma (FFP) is performed to prevent coagulation abnormalities. The hypothesis was that CPB priming with crystalloids would be different compared with FFP in terms of bleeding and/or need for blood product transfusion.
METHODS


In this parallel-arm double-blinded study, patients weighing between 7 and 15 kg were randomly assigned to a CPB priming with 15 ml · kg PlasmaLyte or 15 ml · kg FFP in addition to a predefined amount of packed red blood cells used in all patients. The decision to transfuse was clinical and guided by point-of-care tests. The primary endpoints included postoperative bleeding tracked by chest tubes, number of patients transfused with any additional blood products, and the total number of additional blood products administered intra- and postoperatively. The postoperative period included the first 6 h after intensive care unit arrival.
RESULTS


Respectively, 30 and 29 patients in the FFP and in the crystalloid group were analyzed in an intention-to-treat basis. Median postoperative blood loss was 7.1 ml · kg (5.1, 9.4) in the FFP group and 5.7 ml · kg (3.8, 8.5) in the crystalloid group (P = 0.219); difference (95% CI): 1.2 (-0.7 to 3.2). The proportion of patients additionally transfused was 26.7% (8 of 30) and 37.9% (11 of 29) in the FFP and the crystalloid groups, respectively (P = 0.355; odds ratio [95% CI], 1.7 [0.6 to 5.1]). The median number of any blood products transfused in addition to priming was 0 (0, 1) and 0 (0, 2) in the FFP and crystalloid groups, respectively (P = 0.254; difference [95% CI], 0 [0 to 0]). There were no study-related adverse events.
CONCLUSIONS


The results demonstrate that in infants and children, priming CPB with crystalloids does not result in a different risk of postoperative bleeding and need for transfusion of allogeneic blood products.",2020,"Median postoperative blood loss was 7.1 ml · kg (5.1, 9.4) in the FFP group and 5.7 ml · kg (3.8, 8.5) in the crystalloid group (P = 0.219); difference (95% CI): 1.2 (-0.7 to 3.2).","['patients undergoing pediatric cardiac surgery with cardiopulomonary bypass, postoperative bleeding', 'patients weighing between 7 and 15\u2009kg', 'Pediatric Surgery', 'pediatric cardiac surgical patients']","['FFP', 'cardiopulmonary bypass (CPB) with fresh frozen plasma (FFP', 'crystalloid versus fresh frozen plasma', 'CPB priming with 15\u2009ml · kg PlasmaLyte or 15\u2009ml · kg FFP', 'Fresh Frozen Plasma versus Crystalloid Priming of Cardiopulmonary Bypass Circuit']","['postoperative bleeding tracked by chest tubes, number of patients transfused with any additional blood products, and the total number of additional blood products administered intra- and postoperatively', 'median number of any blood products transfused', 'Median postoperative blood loss', 'proportion of patients additionally transfused']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0018830', 'cui_str': 'Heart-Lung Machine'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.326017,"Median postoperative blood loss was 7.1 ml · kg (5.1, 9.4) in the FFP group and 5.7 ml · kg (3.8, 8.5) in the crystalloid group (P = 0.219); difference (95% CI): 1.2 (-0.7 to 3.2).","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Dieu', 'Affiliation': 'From the Departments of Anesthesiology (A.D., M.R.M., A.M., D.K., C.K., M.M.) Hematology (S.E.) Cardiac Surgery (J.R., A.P.) Perfusion Services (D.T., A.G.) the Pediatric Intensive Care Unit (A.H., E.D.), University Hospital Saint Luc, Catholic University of Louvain (Cliniques Universitaires Saint Luc, Université Catholique de Louvain), Brussels, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rosal Martins', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Eeckhoudt', 'Affiliation': ''}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Matta', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Khalifa', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rubay', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Poncelet', 'Affiliation': ''}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Haenecour', 'Affiliation': ''}, {'ForeName': 'Emilien', 'Initials': 'E', 'LastName': 'Derycke', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Thiry', 'Affiliation': ''}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Gregoire', 'Affiliation': ''}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Momeni', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003017']
118,32325490,"Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial.","Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The addition of daratumumab (D) to RVd (D-RVd) in transplant-eligible NDMM patients was evaluated. Patients (N = 207) were randomized 1:1 to D-RVd or RVd induction (4 cycles), ASCT, D-RVd or RVd consolidation (2 cycles), and lenalidomide or lenalidomide plus D maintenance (26 cycles). The primary end point, stringent complete response (sCR) rate by the end of post-ASCT consolidation, favored D-RVd vs RVd (42.4% vs 32.0%; odds ratio, 1.57; 95% confidence interval, 0.87-2.82; 1-sided P = .068) and met the prespecified 1-sided α of 0.10. With longer follow-up (median, 22.1 months), responses deepened; sCR rates improved for D-RVd vs RVd (62.6% vs 45.4%; P = .0177), as did minimal residual disease (MRD) negativity (10-5 threshold) rates in the intent-to-treat population (51.0% vs 20.4%; P < .0001). Four patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group progressed; respective 24-month progression-free survival rates were 95.8% and 89.8%. Grade 3/4 hematologic adverse events were more common with D-RVd. More infections occurred with D-RVd, but grade 3/4 infection rates were similar. Median CD34+ cell yield was 8.2 × 106/kg for D-RVd and 9.4 × 106/kg for RVd, although plerixafor use was more common with D-RVd. Median times to neutrophil and platelet engraftment were comparable. Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT02874742.",2020,There was no difference in median times to neutrophil or platelet engraftment.,"['ASCT-eligible NDMM patients', 'patients with transplant-eligible NDMM', 'Patients (N=207', 'Transplant-eligible Newly Diagnosed Multiple Myeloma', 'transplant-eligible patients with newly diagnosed multiple myeloma (NDMM']","['RVd ±D induction (4 cycles), ASCT, RVd ±D consolidation (2 cycles), and lenalidomide ±D maintenance', 'Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT', 'Daratumumab, Lenalidomide, Bortezomib, & Dexamethasone', 'plerixafor']","['median times to neutrophil or platelet engraftment', 'stringent complete response (sCR) rate', 'Median CD34+ cell yield', 'depth of response', '24-month progression-free survival rates', 'Grade 3/4 hematologic adverse events', 'minimal residual disease negativity']","[{'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",207.0,0.136648,There was no difference in median times to neutrophil or platelet engraftment.,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Laubach', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, School of Medicine, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology and Oncology, School of Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Silbermann', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Anderson', 'Affiliation': 'Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Yvonne A', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Holstein', 'Affiliation': 'Division of Oncology & Hematology, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Costello', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Wildes', 'Affiliation': 'Section of Medical Oncology, Division of Oncology, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Shain', 'Affiliation': 'Department of Malignant Hematology, H. Lee Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cowan', 'Affiliation': 'Division of Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Lutska', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA; and.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'de Boer', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hoehn', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Lin', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Blood,['10.1182/blood.2020005288']
119,32300129,Mindfulness Meditation Activates Altruism.,"Clinical evidence suggests that mindfulness meditation reduces anxiety, depression, and stress, and improves emotion regulation due to modulation of activity in neural substrates linked to the regulation of emotions and social preferences. However, less was known about whether mindfulness meditation might alter pro-social behavior. Here we examined whether mindfulness meditation activates human altruism, a component of social cooperation. Using a simple donation game, which is a real-world version of the Dictator's Game, we randomly assigned 326 subjects to a mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation. Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics. We also found a larger treatment effect of meditation among those who did not go to college (p < 0.001) and those who were under 25 years of age (p < 0.001), with both subject groups contributing virtually nothing in the control condition. Our results imply high context modularity of human altruism and the development of intervention approaches including mindfulness meditation to increase social cooperation, especially among subjects with low baseline willingness to contribute.",2020,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.",['326 subjects to a'],"['mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation', 'mindfulness meditation']","['anxiety, depression, and stress, and improves emotion regulation']","[{'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",326.0,0.0125002,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.","[{'ForeName': 'Sage K', 'Initials': 'SK', 'LastName': 'Iwamoto', 'Affiliation': 'College of Letters & Sciences, UC Berkeley, Berkeley, CA, 94720, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Mindful Awareness Research Center and Cousins Center for Psychoneuroimmunology, Jane and Terry Semel Institute for Neuroscience at UCLA, and Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nishi', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, 90095, United States. akihironishi@ucla.edu.'}]",Scientific reports,['10.1038/s41598-020-62652-1']
120,31784483,Genetic variability and potential effects on clinical trial outcomes: perspectives in Parkinson's disease.,"BACKGROUND


Classical randomisation of clinical trial patients creates a source of genetic variance that may be contributing to the high failure rate seen in neurodegenerative disease trials. Our objective was to quantify genetic difference between randomised trial arms and determine how imbalance can affect trial outcomes.
METHODS


5851 patients with Parkinson's disease of European ancestry data and two simulated virtual cohorts based on public data were used. Data were resampled at different sizes for 1000 iterations and randomly assigned to the two arms of a simulated trial. False-negative and false-positive rates were estimated using simulated clinical trials, and per cent difference in genetic risk score (GRS) and allele frequency was calculated to quantify variance between arms.
RESULTS


5851 patients with Parkinson's disease (mean (SD) age, 61.02 (12.61) years; 2095 women (35.81%)) as well as simulated patients from virtually created cohorts were used in the study. Approximately 90% of the iterations had at least one statistically significant difference in individual risk SNPs between each trial arm. Approximately 5%-6% of iterations had a statistically significant difference between trial arms in mean GRS. For significant iterations, the average per cent difference for mean GRS between trial arms was 130.87%, 95% CI 120.89 to 140.85 (n=200). Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50). When adding a drug effect of -0.5 points in MDS-UPDRS per year at n=50, 33.9% of trials resulted in false negatives.
CONCLUSIONS


Our data support the hypothesis that within genetically unmatched clinical trials, genetic heterogeneity could confound true therapeutic effects as expected. Clinical trials should undergo pretrial genetic adjustment or, at the minimum, post-trial adjustment and analysis for failed trials.",2020,"Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50).","[""5851 patients with Parkinson's disease of European ancestry data and two simulated virtual cohorts based on public data were used"", ""5851 patients with Parkinson's disease (mean (SD) age, 61.02"", '12.61) years; 2095 women (35.81%)) as well as simulated patients from virtually created cohorts were used in the study', ""Parkinson's disease""]",[],"['false negatives', 'genetic risk score (GRS) and allele frequency', 'individual risk SNPs', 'GRS scores', 'False-negative and false-positive rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0205558', 'cui_str': 'False negative (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017270', 'cui_str': 'Allele Frequency'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}]",2095.0,0.444393,"Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50).","[{'ForeName': 'Hampton', 'Initials': 'H', 'LastName': 'Leonard', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Blauwendraat', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Krohn', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Faghri', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Ferguson', 'Affiliation': 'Caserta Concepts LLC, New York City, New York, USA.'}, {'ForeName': 'Aaron G', 'Initials': 'AG', 'LastName': 'Day-Williams', 'Affiliation': 'Merck and Co, Boston, Massachusetts, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stone', 'Affiliation': 'Merck and Co, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Singleton', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mike A', 'Initials': 'MA', 'LastName': 'Nalls', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA ziv.gan-or@mcgill.ca mike@datatecnica.com.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gan-Or', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Québec, Canada ziv.gan-or@mcgill.ca mike@datatecnica.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of medical genetics,['10.1136/jmedgenet-2019-106283']
121,31151855,Perceptions of safety monitoring in CF clinical studies and potential impact on future study participation.,"BACKGROUND


Individuals with CF and their parents cite safety concerns as barriers to participating in clinical studies. We assessed whether a brochure/infographic describing patient safety monitoring processes could reduce knowledge and attitude barriers regarding safety monitoring. We also identified factors associated with likely participation in future CF studies.
METHODS


Respondents from three CF centers in the U.S. were randomly assigned to receive the safety monitoring brochure/infographic or an unrelated brochure. Fifty parents of children with CF <16, 50 adolescents with CF 16-21, and 50 adults with CF ≥22 years old were recruited to complete the study survey. Factors associated with survey responses and with reported likelihood of participating in future studies were assessed.
RESULTS


Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI 95  1.01-5.28), but not in drug studies. Non-Hispanic respondents reported greater likelihood of participating in a future drug study than Hispanic respondents (aOR 3.18, CI 95  1.30-7.74). Adults with CF (aOR 2.62, CI 95  1.05-6.51) and parents (aOR 4.49, CI 95  1.66-12.15) were more likely than adolescents to report they would ask their care team about clinical trials. Confidence in safety monitoring was associated with reported likelihood of future participation in drug studies.
CONCLUSIONS


Potential future participation in CF drug and/or non-drug studies was associated with respondent age and ethnicity, receiving the safety monitoring brochure/infographic, and confidence in safety monitoring. Our findings underscore the need for education about safety monitoring, with targeted approaches for the Hispanic CF population and adolescents.",2019,"Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI 95  1.01-5.28), but not in drug studies.","['Respondents from three CF centers in the U.S', 'Hispanic CF population and adolescents', 'Fifty parents of children with CF <16, 50 adolescents with CF 16-21, and 50 adults with CF ≥22\u202fyears old were recruited to complete the study survey']",['safety monitoring brochure/infographic or an unrelated brochure'],[],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}]",[],,0.0927611,"Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI 95  1.01-5.28), but not in drug studies.","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kern-Goldberger', 'Affiliation': 'Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Hill-Ricciuti', 'Affiliation': 'Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Juyan J', 'Initials': 'JJ', 'LastName': 'Zhou', 'Affiliation': 'Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Adrienne P', 'Initials': 'AP', 'LastName': 'Savant', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL 60611, USA.""}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Rugg', 'Affiliation': ""Division of Pulmonary and Sleep Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL 60611, USA.""}, {'ForeName': 'Allen J', 'Initials': 'AJ', 'LastName': 'Dozor', 'Affiliation': 'Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine, New York Medical College and Westchester Medical Center, Valhalla, NY 10595, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Welter', 'Affiliation': 'Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine, New York Medical College and Westchester Medical Center, Valhalla, NY 10595, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saiman', 'Affiliation': 'Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Quittell', 'Affiliation': 'Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA. Electronic address: lmq1@cumc.columbia.edu.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.05.001']
122,31605667,Cooled Radiofrequency Ablation Treatment of the Genicular Nerves in the Treatment of Osteoarthritic Knee Pain: 18- and 24-Month Results.,"OBJECTIVE


The primary objective of this observational, prospective, multicenter study was to evaluate the long-term outcomes, including pain, function, and perceived effect of treatment, in subjects undergoing cooled radiofrequency ablation (CRFA) who have pain due to osteoarthritis (OA) of the knee.
METHODS


This analysis included a subset of subjects previously enrolled in a prospective, multicenter randomized study comparing the safety and effectiveness of CRFA and intra-articular steroid injection in patients with knee OA through 12 months who were contacted to participate in this extension study. Subjects were enrolled if they agreed to participate in up to 2 additional follow-ups, at 18 and 24 months.
RESULTS


Eighty-three subjects from the 5 participating sites underwent CRFA during the original study and were contacted for this extension study. Of the 33 subjects enrolled, 25 were evaluated at 18 months after CRFA treatment, and their mean numeric rating scale (NRS) score was 3.1 ± 2.7, with 12 subjects reporting ≥50% pain relief compared to baseline. At 24 months, 18 subjects reported a mean NRS score of 3.6 ± 2.8, with 11 demonstrating ≥50% pain relief. Functional improvement as measured by the Oxford Knee Score continued to be present, with an overall mean change from baseline of 26.0 ± 9.6 points at 18 months and 29.9 ± 10.4 points at 24 months.
CONCLUSION


In this subset of subjects from a randomized controlled trial, CRFA provided sustained pain relief, improved function, and perceived positive effect through 24 months for subjects with OA knee pain with no safety concerns identified.",2020,"Functional improvement via Oxford Knee Score (OKS) continued to be present with an overall mean change from baseline of 26.0 ± 9.6 points at 18 months and 29.9 ± 10.4 points at 24 months.
","['knee OA patients through 12 months', 'subjects who have pain due to osteoarthritis (OA) of the knee', 'Osteoarthritic Knee Pain', 'Subjects were enrolled if they agreed to participate in up to two additional follow-ups, at 18- and', 'subjects with OA knee pain', 'Eighty-three subjects from the five participating sites received']","['Cooled Radiofrequency Ablation', 'CRFA', 'cooled radiofrequency ablation (CRFA', 'CRFA and intra-articular steroid (IAS) injection']","['mean Numeric Rating Scale (NRS) score', 'mean NRS score', 'sustained pain relief', 'pain relief', 'Functional improvement via Oxford Knee Score (OKS']","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}]",83.0,0.0409417,"Functional improvement via Oxford Knee Score (OKS) continued to be present with an overall mean change from baseline of 26.0 ± 9.6 points at 18 months and 29.9 ± 10.4 points at 24 months.
","[{'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Hunter', 'Affiliation': 'Ainsworth Institute of Pain Management, New York, New York, U.S.A.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Davis', 'Affiliation': 'Orthopedic Pain Specialists, Santa Monica, California, U.S.A.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Loudermilk', 'Affiliation': 'Piedmont Comprehensive Pain Management Group, Greenville, South Carolina, U.S.A.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Center for Clinical Research, Winston Salem, North Carolina, U.S.A.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DePalma', 'Affiliation': 'Virginia iSpine Physicians, Richmond, Virginia, U.S.A.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12844']
123,30161090,Comparison of Linear and Reverse Linear Periodized Programs With Equated Volume and Intensity for Endurance Running Performance.,"Bradbury, DG, Landers, GJ, Benjanuvatra, N, and Goods, PS. Comparison of linear and reverse linear periodized programs with equated volume and intensity for endurance running performance. J Strength Cond Res 34(5): 1345-1353, 2020-This investigation examined the effectiveness of 2 periodization methods on endurance running performance. Thirty recreational runners (25.2 ± 7.4 years; 175.4 ± 8.1 cm; 69.0 ± 9.8 kg) were assigned to 3 groups based on preintervention test results: linear periodization group (LPG, n = 10), reverse linear periodization group (RPG, n = 10), and control group (CG, n = 10). The LPG and RPG completed 3 training sessions (2 supervised and 1 unsupervised) per week in two 6-week blocks. The LPG went through a high-volume training program while the RPG performed higher intensity, lower volume training in the initial block. Training volume and intensity was reversed in the second 6-week training block. All subjects completed pre-training (week 0), midpoint (week 7), and post-training (week 14) testing, which included anthropometric measurements (body mass and sum of 8 skinfolds), treadmill tests for running economy (RE) and V[Combining Dot Above]O2max, and a 5,000-m time trial (TT) on a 400-m grass track. Greater improvements in the 5,000-m TT were observed in the LPG (76.8 ± 55.8 seconds, p = 0.009, d = 1.27) and the RPG (112.8 ± 83.4 seconds, p = 0.002, d = 1.51) than the CG (3.6 ± 59 seconds). No significant differences were found between the LPG and RPG (p = 0.321, d = 0.51). No group differences were found for V[Combining Dot Above]O2peak (p = 0.955) or RE at 9 km·h (p = 0.329) or 11 km·h (p = 0.558), respectively. However, significant improvements were seen in these variables after training: V[Combining Dot Above]O2peak (p = 0.010), RE 9 km·h (p < 0.001), and RE 11 km·h (p = 0.004). These results do not support linear periodization or reverse linear periodization as a superior method; however, periodized training elicited greater improvements in endurance performance than nonperiodized training, highlighting the importance of planned training structure.",2020,No group differences were found for V[Combining,['Thirty recreational runners (25.2 ± 7.4 years; 175.4 ± 8.1 cm; 69.0 ± 9.8 kg'],"['J Strength Cond Res XX(X', 'treadmill tests for running economy (RE) and V[Combining', 'linear periodization group (LPG, n = 10), reverse linear periodization group (RPG', 'V[Combining']","['endurance running performance', 'V[Combining', 'Bradbury, DG, Landers, GJ, Benjanuvatra, N, and Goods, PS', 'endurance performance']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}]","[{'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",,0.0149748,No group differences were found for V[Combining,"[{'ForeName': 'Duncan G', 'Initials': 'DG', 'LastName': 'Bradbury', 'Affiliation': 'School of Human Sciences (Sport Science), University of Western Australia, Perth, Australia.'}, {'ForeName': 'Grant J', 'Initials': 'GJ', 'LastName': 'Landers', 'Affiliation': 'School of Human Sciences (Sport Science), University of Western Australia, Perth, Australia.'}, {'ForeName': 'Nat', 'Initials': 'N', 'LastName': 'Benjanuvatra', 'Affiliation': 'School of Human Sciences (Sport Science), University of Western Australia, Perth, Australia.'}, {'ForeName': 'Paul S R', 'Initials': 'PSR', 'LastName': 'Goods', 'Affiliation': 'School of Human Sciences (Sport Science), University of Western Australia, Perth, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002805']
124,32321955,Effect of self-assembling peptide P 11 -4 on orthodontic treatment-induced carious lesions.,"This study aimed to evaluate the effect of self-assembling peptide P 11 -4 (SAP) in the therapy of initial smooth surface caries (white spot lesions, WSL) following orthodontic multibracket treatment. Twenty-three patients (13f/10m; average age 15.4 years) with at least two teeth with WSL were recruited for the randomised controlled clinical trial with split-mouth design. In opposite to the control teeth, the test teeth were treated with SAP on Day 0. The primary endpoint was the impedance measurement of WSL using customised tray to ensure reproducibility of the measurement location. The secondary endpoint was the morphometric measurement of WSL using a semi-automated approach to determine the WSL size in mm 2 . Treatment effects were adjusted for site-specific baseline values using mixed models adapted from the cross-over design. Test WSL showed a mean baseline impedance value of 46.7, which decreased to 21.1, 18.4, and 19.7 after 45, 90, and 180 days, respectively. Control WSL showed a mean baseline value of 42.0, which decreased to 35.0, 29.5, and 33.7, respectively. The overall treatment contrast was -13.7 (95% CI: -19.6 - -7.7; p < 0.001). For the secondary endpoint, the test WSL size decreased from 8.8 at baseline to 6.5 after 180 days. The control WSL decreased from 6.8 to 5.7, respectively. The related treatment contrast was -1.0 in favour of test WSL (95% CI: -1.6 - -0.5; p = 0.004). The treatment of initial carious lesions with self-assembling peptide P 11 -4 leads to superior remineralisation of the subsurface lesions compared with the control teeth.",2020,The treatment of initial carious lesions with self-assembling peptide P 11 -4 leads to superior remineralisation of the subsurface lesions compared with the control teeth.,"['Twenty-three patients (13f/10m; average age 15.4 years) with at least two teeth with WSL', 'orthodontic treatment-induced carious lesions', 'initial smooth surface caries (white spot lesions, WSL) following orthodontic multibracket treatment']","['self-assembling peptide P 11 -4', 'self-assembling peptide P 11 -4 (SAP']","['impedance measurement of WSL using customised tray to ensure reproducibility of the measurement location', 'WSL size', 'mean baseline impedance value', 'control WSL', 'morphometric measurement of WSL']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2024965', 'cui_str': 'Caries of smooth surface of tooth'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0647980', 'cui_str': 'peptide P (properdin)'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}]","[{'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0611299,The treatment of initial carious lesions with self-assembling peptide P 11 -4 leads to superior remineralisation of the subsurface lesions compared with the control teeth.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Welk', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Restorative Dentistry, Periodontology, Endodontology, Preventive and Pediatric Dentistry, Greifswald, Germany. welk@uni-greifswald.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ratzmann', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Orthodontics, Greifswald, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reich', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Restorative Dentistry, Periodontology, Endodontology, Preventive and Pediatric Dentistry, Greifswald, Germany.'}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Krey', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Orthodontics, Greifswald, Germany.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Schwahn', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Prosthodontics, Greifswald, Germany.'}]",Scientific reports,['10.1038/s41598-020-63633-0']
125,32322023,Quality of chest compressions during pediatric resuscitation with 15:2 and 30:2 compressions-to-ventilation ratio in a simulated scenario.,"The main objetive was to compare 30:2 and 15:2 compression-to-ventilation ratio in two simulated pediatric cardiopulmonary resuscitation (CPR) models with single rescuer. The secondary aim was to analyze the errors or omissions made during resuscitation. A prospective randomized parallel controlled study comparing 15:2 and 30:2 ratio in two manikins (child and infant) was developed. The CPR was performed by volunteers who completed an basic CPR course. Each subject did 4 CPR sessions of 3 minutes each one. Depth and rate of chest compressions (CC) during resuscitation were measured using a Zoll Z series defibrillator. Visual assessment of resuscitation was performed by an external researcher. A total of 26 volunteers performed 104 CPR sessions. Between 54-62% and 44-53% of CC were performed with an optimal rate and depth, respectively, with no significant differences. No differences were found in depth or rate of CC between 15:2 and 30:2 compression-to-ventilation ratio with both manikins. In the assessment of compliance with the ERC CPR algorithm, 69.2-80.8% of the subjects made some errors or omissions during resuscitation, the most frequent was not asking for help and not giving rescue breaths. The conclusions were that a high percentage of CC were not performed with optimal depth and rate. Errors or omissions were frequently made by rescuers during resuscitation.",2020,No differences were found in depth or rate of CC between 15:2 and 30:2 compression-to-ventilation ratio with both manikins.,['26 volunteers performed 104 CPR sessions'],['pediatric resuscitation with 15:2 and 30:2 compressions-to-ventilation ratio'],"['Quality of chest compressions', 'depth or rate of CC', 'Depth and rate of chest compressions (CC', 'Visual assessment of resuscitation']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",26.0,0.0126162,No differences were found in depth or rate of CC between 15:2 and 30:2 compression-to-ventilation ratio with both manikins.,"[{'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Manrique', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañon University Hospital, Madrid, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Public Health, Maternal and Child Department, School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Maitane', 'Initials': 'M', 'LastName': 'Iguiñiz', 'Affiliation': 'Public Health, Maternal and Child Department, School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Grau', 'Affiliation': 'Public Health, Maternal and Child Department, School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Toledo', 'Affiliation': 'Pediatric Department, Gregorio Marañon University Hospital, Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'García', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañon University Hospital, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Herce', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañon University Hospital, Madrid, Spain. pielvi@hotmail.com.'}]",Scientific reports,['10.1038/s41598-020-63921-9']
126,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
127,32146521,Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS


Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.
METHODS


This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.
RESULTS


Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.
CONCLUSIONS


Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.",2020,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","['women with advanced prolapse versus stage II prolapse', 'women with advanced prolapse (stage III-IV) and stress urinary incontinence', 'women with advanced vaginal prolapse', 'women with advanced pelvic organ prolapse and stress urinary incontinence', 'women with advanced prolapse', 'Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse']","['ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care', 'uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF', 'native tissue transvaginal apical approaches']","['Serious adverse events', 'individual success components', 'Surgical success, symptom severity, and overall serious adverse events', 'Prolapse symptom severity scores', 'individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0205990', 'cui_str': 'Vaginal Prolapse'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",374.0,0.18451,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","[{'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Whitworth', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA.'}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Ackenbom', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Clifford Y', 'Initials': 'CY', 'LastName': 'Wai', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-020-04271-y']
128,32325012,"Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial.","BACKGROUND


Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections.
METHODS


In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual.
FINDINGS


Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ 2  test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
INTERPRETATION


The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery.
FUNDING


Fundación Asociación Española de Coloproctología.",2020,"No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
","['patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated', '13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention', 'Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated', 'Between May 2, 2015, and April 15, 2017', 'colon surgery (ORALEV', '582 patients for eligibility, of whom 565 were eligible']","['cefuroxime 1·5 g and metronidazole', 'metronidazole', 'ciprofloxacin', 'no oral antibiotics (n=282) or oral antibiotics', 'Preoperative oral antibiotics and surgical-site infections', 'oral antibiotics', 'oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group']","['risk of surgical-site infections', 'incidence of surgical-site infections', 'local complications, surgical complications, or medical complications', 'More complications (including surgical-site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0586901', 'cui_str': 'Colorectal surgeon'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1510475', 'cui_str': 'Diverticula of intestine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0149750', 'cui_str': 'Partial resection of colon'}, {'cui': 'C0192871', 'cui_str': 'Total colectomy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",582.0,0.193492,"No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications.
","[{'ForeName': 'Eloy', 'Initials': 'E', 'LastName': 'Espin Basany', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain. Electronic address: eespin@vhebron.net.""}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Solís-Peña', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pellino', 'Affiliation': ""Colorectal Surgery Unit, Department of General Surgery, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kreisler', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}, {'ForeName': 'Doménico', 'Initials': 'D', 'LastName': 'Fraccalvieri', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Muinelo-Lorenzo', 'Affiliation': 'Colorectal Surgery Unit, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Maseda-Díaz', 'Affiliation': 'Colorectal Surgery Unit, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'García-González', 'Affiliation': 'Coloproctology Surgery Unit, Department of General and Digestive Surgery, Cruces University Hospital, Barakaldo, Bzkaia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santamaría-Olabarrieta', 'Affiliation': 'Coloproctology Surgery Unit, Department of General and Digestive Surgery, Cruces University Hospital, Barakaldo, Bzkaia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Codina-Cazador', 'Affiliation': 'Colorectal Surgery Unit, Hosiptal Universitario Gerona, Universidad de Gerona, Girona, Spain.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Biondo', 'Affiliation': ""Colorectal Surgery Unit, Bellvitge University Hospital, Department of General and DIigestive Surgery-Colorectal Unit, University of Barcelona and Institut d'Investigacio Biomedica de Bellvitge, Barcelona, Spain.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30075-3']
129,32325162,Effects of an Individualized Comprehensive Rehabilitation Program on Impaired Postural Control in Women With Chronic Pelvic Pain: A Randomized Controlled Trial.,"OBJECTIVE


To assess the effectiveness of an individualized comprehensive rehabilitation program (ICPR) on impaired postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain.
DESIGN


Randomized controlled trial.
SETTING


Women with chronic pelvic pain were recruited from the Gynecology Department of the University Hospital San Cecilio in Granada, Spain.
PARTICIPANTS


Participants (N=38) who were randomly divided into 2 groups.
INTERVENTIONS


The intervention group received an 8-week ICRP, and the control group received a leaflet with ergonomic information.
MAIN OUTCOME MEASURES


The main outcomes included were postural control (Mini Balance Evaluation Systems [Mini BESTest] and timed Up and Go [TUG]), pain (Brief Pain Inventory), self-perceived health status (EuroQol 5 dimensions [EQ-5D]), and functionality (Oswestry Disability Index [ODI]).
RESULTS


Significant differences were found between groups in the Mini BESTest and TUG scores with large effect sizes. The Brief Pain Inventory, EQ-5D, and ODI also presented significant differences in the between-groups analysis, with better scores in the intervention group after treatment. In the follow-up analysis, significant differences were found between groups in the Mini BESTest (P<.001), the cognitive TUG subscale (P=.032), interference of pain (P<.001), anxiety and depression (P=.001), and visual analog scale EQ-5D (P=.026) subscales, as well as the ODI (P<.001).
CONCLUSIONS


Our results show significant improvements on postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain who received an 8-week ICRP.",2020,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","['Women with chronic pelvic pain were recruited from the Gynaecology Department of the ""Hospital San Cecilio"" in Granada', '38 participants were included in the study and randomly divided into two groups', 'women with CPP', 'women with chronic pelvic pain']","['Individualized Comprehensive Rehabilitation Program', 'eight-week ICRP and the control group received a leaflet with ergonomic information', 'Individualized Comprehensive Rehabilitation Program (ICPR']","['Mini BESTest and TUG scores', 'VAS EQ-5D', 'interference of pain (p<0.001), anxiety/depression', 'postural control (Mini Balance Evaluation Systems, Mini BESTest and Timed Up and Go Test, TUG), pain (Brief Pain Inventory, BPI), self-perceived health status (Euroqol-5dimensions, EQ-5D) and functionality (Oswestry Disability Index, ODI', 'postural control', 'BPI, EQ-5D and ODI', 'cognitive TUG subscale', 'postural control, pain, self-perceived health status and functionality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",38.0,0.0673424,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Prados-Román', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Granados-Santiago', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain. Electronic address: cvalenza@ugr.es.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.019']
130,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND


Postnatal growth restriction (PNGR) in premature infants increases risk of pulmonary hypertension (PH). In a rodent model, PNGR causes PH, while combining PNGR and hyperoxia increases PH severity. We hypothesized that PNGR causes intestinal dysbiosis and that treatment with a probiotic attenuates PNGR-associated PH.
METHOD


Pups were randomized at birth to room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR (17 pups/dam), and to probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline. After 14 days, PH was assessed by echocardiography and right ventricular hypertrophy (RVH) was assessed by Fulton's index (right ventricular weight/left ventricle + septal weight). The small bowel and cecum were analyzed by high-throughput 16S ribosomal RNA gene sequencing.
RESULTS


PNGR with or without hyperoxia (but not hyperoxia alone) altered the microbiota of the distal small bowel and cecum. Treatment with DSM 17938 attenuated PH and RVH in pups with PNGR, but not hyperoxia alone. DSM 17938 treatment decreased α-diversity. The intestinal microbiota differed based on oxygen exposure, litter size, and probiotic treatment.
CONCLUSION


PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2']
131,32328782,Comparison of Lobectomy and Total Thyroidectomy in Unilateral Papillary Thyroid Microcarcinoma Patients with Ipsilateral Lateral Lymph Node Metastasis Without Gross Extrathyroidal Extension.,"BACKGROUND


Lateral lymph node metastasis (LLNM) occurs in a few of papillary thyroid microcarcinoma (PTMC) cases by the time of diagnosis. Total thyroidectomy (TT) is recommended in the 2015 American Thyroid Association guidelines as the initial surgical procedure for thyroid carcinoma patients with clinically apparent cervical lymph node metastasis. However, none of the controlled studies have focused on the proper extent of surgery for patients who have PTMC with concomitant LLNM without gross extrathyroidal extension (ETE).
METHODS


A total of 2373 consecutive patients with PTMC were retrospectively reviewed. Finally, 129 unilateral PTMC patients with ipsilateral LLNM without gross ETE were enrolled in this study and classified into two groups: those who underwent unilateral lobectomy (LT) plus lymph node dissection (LND) (Group I) and those who underwent TT plus LND (Group II). Surgical outcomes and recurrence-free survival (RFS) during the follow-up period were compared between the two groups.
RESULTS


There were 62 patients in Group I and 67 patients in Group II. Cases in Group II had a longer median operation time (150 min vs. 120 min, p < 0.001) and a higher incidence of postoperative hypoparathyroidism (p < 0.001), especially permanent hypoparathyroidism, than cases in Group I. But the RFS showed no statistically significant difference (p = 0.6005) between the two groups during a median follow-up period of 60 months.
CONCLUSION


Thyroid LT alone plus ipsilateral LND may be an optimum initial procedure for unilateral PTMC patients with ipsilateral LLNM without gross ETE. A long-term follow-up, prospective, randomized controlled trial is warranted.",2020,"Cases in Group II had a longer median operation time (150 min vs. 120 min, p < 0.001) and a higher incidence of postoperative hypoparathyroidism (p < 0.001), especially permanent hypoparathyroidism, than cases in Group I.","['thyroid carcinoma patients with clinically apparent cervical lymph node metastasis', '2373 consecutive patients with PTMC', 'Unilateral Papillary Thyroid Microcarcinoma Patients with Ipsilateral Lateral Lymph Node Metastasis Without Gross Extrathyroidal Extension', 'unilateral PTMC patients with ipsilateral LLNM without gross ETE', 'patients who have PTMC with concomitant LLNM without gross extrathyroidal extension (ETE', '129 unilateral PTMC patients with ipsilateral LLNM without gross ETE']","['unilateral lobectomy (LT) plus lymph node dissection (LND', 'Lobectomy and Total Thyroidectomy', 'Total thyroidectomy (TT', 'TT plus LND', 'Thyroid LT alone plus ipsilateral LND']","['permanent hypoparathyroidism', 'postoperative hypoparathyroidism', 'longer median operation time', 'Surgical outcomes and recurrence-free survival (RFS']","[{'cui': 'C0549473', 'cui_str': 'Thyroid Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1709457', 'cui_str': 'Papillary Thyroid Microcarcinoma'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0342341', 'cui_str': 'Post-surgical hypoparathyroidism'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",2373.0,0.0291085,"Cases in Group II had a longer median operation time (150 min vs. 120 min, p < 0.001) and a higher incidence of postoperative hypoparathyroidism (p < 0.001), especially permanent hypoparathyroidism, than cases in Group I.","[{'ForeName': 'Jianlu', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Wangwang', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Youben', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China. fanyouben2006@163.com.""}, {'ForeName': 'Zhili', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China. yangzhililaoshi@126.com.""}]",World journal of surgery,['10.1007/s00268-020-05514-1']
132,32320144,Weight Change 2 Years After Termination of the Intensive Lifestyle Intervention in the Look AHEAD Study.,"OBJECTIVE


This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss-maintenance counseling than would participants in the diabetes support and education (DSE) control group.
METHODS


Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes. Look AHEAD was converted to an observational study in September 2012.
RESULTS


Two years after the end of the intervention (EOI), ILI and DSE participants lost a mean  (SE) of 1.2  (0.2) kg and 1.8  (0.2) kg, respectively (P = 0.003). In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001). Two years after the EOI, ILI participants reported greater use of weight-control behaviors than DSE participants.
CONCLUSIONS


Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.",2020,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","['participants with overweight/obesity and type 2 diabetes', 'Two years after the end of the intervention (EOI), ILI and DSE participants', 'Weight Change 2 Years']","['ILI and DSE', '10-year intensive lifestyle intervention (ILI', 'Intensive Lifestyle Intervention']","['cardiovascular morbidity and mortality', 'EOI weight', 'gain weight', 'weight-control behaviors']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}]",,0.0402555,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Division of Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bolin', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Ewing', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Gay', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Department of Integrative Physiology and Metabolism, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Michalski', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reboussin', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redmon', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinburg', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22769']
133,28902116,Adding Whole-Body Vibration to Preconditioning Squat Exercise Increases Cycling Sprint Performance.,"Duc, S, Rønnestad, BR, and Bertucci, W. Adding whole-body vibration to preconditioning squat exercise increases cycling sprint performance. J Strength Cond Res 34(5): 1354-1361, 2020-This study investigated the effect of performing a preconditioning exercise with or without whole-body vibration (WBV) on a subsequent cycling sprint performance. Fourteen trained subjects performed 2 separate test sessions in randomized order. After a warm-up, the preconditioning exercise (body-loaded half-squats) was applied: 30 seconds of half-squats with WBV (40 Hz, 2 mm) or 30 seconds of half-squats without WBV with a 10-second all-out sprint performed after 1 minute. Surface electromyography (EMG) was measured from the vastus medialis, vastus lateralis, and gastrocnemius medialis during the sprints. Blood lactate level (BL), heart rate (HR), and rating of perceived exertion (RPE) were determined immediately after the 10-second sprint. Performing preconditioning exercise with WBV resulted in superior peak (1,693 ± 356 vs. 1,637 ± 349 W, p ≤ 0.05) and mean power output (1,121 ± 174 vs. 1,085 ± 175 W, p ≤ 0.05) compared with preconditioning exercise without WBV. Effect sizes showed a moderate and large practical effect of WBV vs. no WBV on peak and mean power output, respectively. No differences were observed between the conditions for BL, HR, and RPE after the sprints and in EMG activity during the sprints. In conclusion, it is plausible to suggest that body-loaded half-squats with WBV acutely induce higher power output levels. The practical application of the current study is that body-loaded squats with WBV can be incorporated into preparations for specific sprint training to improve the quality of the sprint training and also to improve sprint performance in relevant competitions.",2020,"No differences were observed between the conditions for BL, HR and RPE after the sprints and in EMG activity during the sprints.",['Fourteen trained subjects'],"['preconditioning exercise with or without whole-body vibration (WBV', 'preconditioning exercise (body-loaded half squats) was applied: 30-seconds of half-squats with WBV', 'preconditioning squat exercise']","['cycling sprint performance', 'Blood lactate level (BL), heart rate (HR) and rating of perceived exertion (RPE', 'BL, HR and RPE after the sprints and in EMG activity', 'Surface electromyography (EMG']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}]",14.0,0.0215418,"No differences were observed between the conditions for BL, HR and RPE after the sprints and in EMG activity during the sprints.","[{'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Duc', 'Affiliation': 'Research Group in Engineering Sciences (EA 4694), Biomechanics Department, UFR STAPS, University of Reims Champagne-Ardenne, Reims, France.'}, {'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Section for Sport Science, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Bertucci', 'Affiliation': 'Research Group in Engineering Sciences (EA 4694), Biomechanics Department, UFR STAPS, University of Reims Champagne-Ardenne, Reims, France.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002236']
134,28930881,Comparing the Immediate Effects of a Total Motion Release Warm-up and a Dynamic Warm-up Protocol on the Dominant Shoulder in Baseball Athletes.,"Gamma, SC, Baker, R, May, J, Seegmiller, JG, Nasypany, A, and Iorio, SM. Comparing the immediate effects of a total motion release warm-up and a dynamic warm-up protocol on the dominant shoulder in baseball athletes. J Strength Cond Res 34(5): 1362-1368, 2020-A decrease in total range of motion (ROM) of the dominant shoulder may predispose baseball athletes to increased shoulder injury risk; the most effective technique for improving ROM is unknown. The purpose of this study was to compare the immediate effects of Total Motion Release (TMR) to a generic dynamic warm-up program in baseball athletes. Baseball athletes (n = 20) were randomly assigned to an intervention group: TMR group (TMRG; n = 10) or traditional warm-up group (TWG; n = 10). Shoulder ROM measurements were recorded for internal rotation (IR) and external rotation (ER), the intervention was applied, and postmeasurements were recorded. Each group then received the other intervention and postmeasurements were again recorded. The time main effect (p ≤ 0.001) and the time × group interaction effect were significant (p ≤ 0.001) for IR and ER. Post hoc analysis revealed that TMR produced significant increases in mean IR (p ≤ 0.005, d = 1.52) and ER (p ≤ 0.018, d = 1.22) of the dominant shoulder initially. When groups crossed-over, the TMRG experienced a decrease in mean IR and ER after the dynamic warm-up, whereas the TWG experienced a significant increase in mean IR (p ≤ 0.001, d = 3.08) and ER (p ≤ 0.001, d = 2.56) after TMR intervention. Total Motion Release increased IR and ER of the dominant shoulder more than a dynamic warm-up. Dynamic warm-up after TMR also resulted in decreased IR and ER; however, TMR after dynamic warm-up significantly improved IR and ER. Based on these results, TMR is more effective than a generic dynamic warm-up for improving dominant shoulder ROM in baseball players.",2020,"When groups crossed-over, the TMRG experienced a decrease in mean IR and ER after the dynamic warm-up, whereas the TWG experienced a significant increase in mean IR (p ≤ 0.001, d = 3.08) and ER (p ≤ 0.001, d = 2.56) after TMR intervention.","['Baseball athletes (n = 20', 'baseball athletes', 'Baseball Athletes']","['TMR', 'Total Motion Release (TMR', 'Total Motion Release Warm-up and a Dynamic Warm-up Protocol', 'J Strength Cond Res XX(X', 'total motion release warm-up and a dynamic warm-up protocol', 'TMR group (TMRG; n = 10) or traditional warm-up group (TWG']","['mean IR and ER', 'decreased IR and ER', 'IR and ER', 'internal rotation (IR) and external rotation (ER', 'Gamma, SC, Baker, R, May, J, Seegmiller, JG, Nasypany, A, and Iorio, SM', 'time main effect', 'mean IR', 'total range of motion (ROM', 'Shoulder ROM measurements']","[{'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",20.0,0.0187179,"When groups crossed-over, the TMRG experienced a decrease in mean IR and ER after the dynamic warm-up, whereas the TWG experienced a significant increase in mean IR (p ≤ 0.001, d = 3.08) and ER (p ≤ 0.001, d = 2.56) after TMR intervention.","[{'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Gamma', 'Affiliation': 'Department of Sports Medicine, Mount Saint Mary College, Newburgh, New York.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': 'Department of Movement Sciences, University of Idaho, Moscow, Idaho.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'May', 'Affiliation': 'Department of Movement Sciences, University of Idaho, Moscow, Idaho.'}, {'ForeName': 'Jeff G', 'Initials': 'JG', 'LastName': 'Seegmiller', 'Affiliation': 'Department of Movement Sciences, University of Idaho, Moscow, Idaho.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Nasypany', 'Affiliation': 'Department of Movement Sciences, University of Idaho, Moscow, Idaho.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Iorio', 'Affiliation': 'Department of Sports Medicine, Mount Saint Mary College, Newburgh, New York.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002229']
135,29023327,Sodium Bicarbonate Supplementation Delays Neuromuscular Fatigue Without Changes in Performance Outcomes During a Basketball Match Simulation Protocol.,"Ansdell, P and Dekerle, J. Sodium bicarbonate supplementation delays neuromuscular fatigue without changes in performance outcomes during a basketball match simulation protocol. J Strength Cond Res 34(5): 1369-1375, 2020-To investigate the development of neuromuscular fatigue during a basketball game simulation and to ascertain whether sodium bicarbonate (NaHCO3) supplementation attenuates any neuromuscular fatigue that persists. Ten participants ingested 0.2 g·kg of NaHCO3 (or an equimolar placebo dosage of sodium chloride [NaCl]) 90 and 60 minutes before commencing a basketball game simulation (ALK-T vs. PLA-T). Maximal voluntary isometric contractions (MVICs) of the knee extensors and potentiated high- (100 Hz) and low- (10 Hz) frequency doublet twitches were recorded before and after each match quarter for both trials. In addition, 15-m sprint times and layup completion (%) were recorded during each quarter. Maximal voluntary isometric contraction, 100- and 10-Hz twitch forces declined progressively in both trials (p ≤ 0.05) with a less pronounced decrease in MVIC during ALK-T (p < 0.01). Both 100- and 10-Hz twitch forces were also significantly greater in ALK-T (p ≤ 0.05). Fifteen-meter sprint time increased over the course of both trials (∼2%, p < 0.01); however, no significant condition or time effect was found for layup completion (p > 0.05). A basketball simulation protocol induces a substantial amount of neuromuscular (reduction in knee extensor MVICs) and peripheral fatigue with a concomitant increase in 15-m sprint time over the protocol. NaHCO3 supplementation attenuated the rate of fatigue development by protecting contractile elements of the muscle fibers. This study provides coaches with information about the magnitude of fatigue induced by a simulated basketball game and provides evidence of the efficacy of NaHCO3 in attenuating fatigue.",2020,"15 m sprint time increased over the course of both trials (∼2%, P<0.01); however, no significant condition or time effect was found for layup completion (P>0.05).
",[],"['NaHCO3 (or an equimolar placebo dosage of sodium chloride [NaCl', 'NaHCO3 supplementation', 'NaHCO3', 'Sodium bicarbonate supplementation', 'sodium bicarbonate (NaHCO3) supplementation']","['15 m sprint time', 'MVIC', 'rate of fatigue development', 'Isometric maximal voluntary contractions of the knee extensors (MVIC) and potentiated high (100 Hz) and low (10 Hz) frequency doublet twitches', 'Hz twitch forces']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]",10.0,0.0607419,"15 m sprint time increased over the course of both trials (∼2%, P<0.01); however, no significant condition or time effect was found for layup completion (P>0.05).
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ansdell', 'Affiliation': 'Sport, Exercise Science and Medicine (SESAME), University of Brighton, Eastbourne, United Kingdom.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Dekerle', 'Affiliation': 'Sport, Exercise Science and Medicine (SESAME), University of Brighton, Eastbourne, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002233']
136,30551946,Effect of 800 IU Versus 2000 IU Vitamin D3 With or Without a Simple Home Exercise Program on Functional Recovery After Hip Fracture: A Randomized Controlled Trial.,"OBJECTIVES


To evaluate 2 simple strategies, vitamin D 3  and a home exercise program, in functional recovery during the first year after hip fracture.
DESIGN


Secondary analysis of a factorial clinical trial. Patients were randomly allocated to 800 IU (standard of care) or 2000 IU vitamin D 3  and a daily instruction of a simple home exercise program (SHEP) or standard physiotherapy alone during acute care.
SETTING AND PARTICIPANTS


Acute hip fracture patients aged ≥65 years, after hip fracture surgery, admitted to a large hospital in Zurich, Switzerland.
MEASURES


Three objective measures of lower extremity function were assessed at baseline and 6 and 12 months, with the Timed Up and Go test (TUG) as the primary endpoint, and knee flexor and extensor strength, and a self-reported physical function score (PF-10) as secondary endpoints. Linear mixed model regression analyses were based on intention to treat, adjusting for baseline function, time, age, sex, and baseline 25-hydroxyvitamin D level.
RESULTS


We enrolled 173 patients (79.2% women; mean age 84 years; 77.5% living at home). A significant interaction was found between vitamin D 3  dose and SHEP for TUG (P = .045). Thus, findings compared the standard of care reference arm with 800 IU vitamin D 3  without SHEP to 3 interventions arms (800 IU vitamin D 3 +SHEP; 2000 IU vitamin D 3  without SHEP; 2000 IU vitamin D 3 +SHEP). For TUG, over 12 months the 800 IU vitamin D 3 +SHEP group performed significantly better than the standard-of-care group (13.8 vs 19.5 seconds; P = .01). Findings for knee flexor strength were in line with TUG results and approached significance (P = .07), whereas knee extensor strength and PF-10 did not differ by treatments.
CONCLUSIONS/IMPLICATIONS


For functional recovery after hip fracture, combining home exercise with 800 IU vitamin D 3  is superior to no home exercise or 2000 IU vitamin D 3 . None of the interventions improved subjective physical functioning.",2019,A significant interaction was found between vitamin D 3  dose and SHEP for TUG (P = .045).,"['After Hip Fracture', '173 patients (79.2% women; mean age 84\xa0years; 77.5% living at home', 'Acute hip fracture patients aged ≥65\xa0years, after hip fracture surgery']","['vitamin D 3  and a daily instruction of a simple home exercise program (SHEP) or standard physiotherapy alone', 'vitamin D 3  and a home exercise program', '800 IU Versus 2000 IU Vitamin D3 With or Without a Simple Home Exercise Program']","['Functional Recovery', 'knee extensor strength and PF-10', 'subjective physical functioning', 'Timed Up and Go test (TUG', 'knee flexor strength', 'knee flexor and extensor strength, and a self-reported physical function score (PF-10', 'lower extremity function']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1634625', 'cui_str': 'Percent live'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",173.0,0.0893234,A significant interaction was found between vitamin D 3  dose and SHEP for TUG (P = .045).,"[{'ForeName': 'Jerra', 'Initials': 'J', 'LastName': 'Stemmle', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University Hospital Zurich and City Hospital Waid Zurich, Switzerland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Marzel', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University Hospital Zurich and City Hospital Waid Zurich, Switzerland.'}, {'ForeName': 'Patricia O', 'Initials': 'PO', 'LastName': 'Chocano-Bedoya', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University Hospital Zurich and City Hospital Waid Zurich, Switzerland.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'USDA Human Nutrition Research Centre on Aging, Tufts University, Boston, MA.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Freystaetter', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University Hospital Zurich and City Hospital Waid Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University Hospital Zurich and City Hospital Waid Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University Hospital Zurich and City Hospital Waid Zurich, Switzerland.'}, {'ForeName': 'Hannes B', 'Initials': 'HB', 'LastName': 'Staehelin', 'Affiliation': 'Department of Geriatrics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University Hospital Zurich and City Hospital Waid Zurich, Switzerland; University Clinic for Acute Geriatric Care, City Hospital Waid, Zurich, Switzerland. Electronic address: Heike.Bischoff@usz.ch.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.10.013']
137,32199717,The benefit of bilateral inferior alveolar nerve block in managing postoperative nausea and vomiting (PONV) after mandibular osteotomy.,"INTRODUCTION


The purpose of our study was to evaluate the benefit of bilateral inferior alveolar nerve block (BIANB) in managing postoperative pain, nausea and vomiting and opioid and antiemetic consumption in mandibular osteotomy.
MATERIAL AND METHODS


51 patients operated for bilateral sagittal split osteotomy (BSSO) were included in this prospective randomized controlled, double-blind, superiority trial. In the first group (n = 25), standard protocol was applied (general anesthesia and postoperative multimodal analgesia). The second group (n = 26) received bilateral inferior alveolar nerve block anesthesia at the start of surgery in addition to routine protocol. Postoperative monitoring was conducted every 4 h over the first 24 h and targeted the following criteria: postoperative nausea and vomiting (PONV), the visual analog scale (VAS) for pain, consumption of morphine (cumulative dose) and antiemetic agents, need for removal of guiding elastics.
RESULTS


PONV was significantly lower in the BIANB group (15.4 % VS 40 %, p = 0.049), as were mean VAS scores for pain (1 VS 1.57, p = 0.045) and medians of morphine bolus (8 [6-16] VS 5.5 [1-8], p = 0.033). We found no significant difference in incidence of guiding elastic removal, and antiemetic consumption.
DISCUSSION


The use of BIANB in BSSO improved postoperative patient comfort in terms of PONV and pain. Furthermore, it led to a decrease in opioid consumption. In conclusion, it is an additional therapeutic means of improving patients' postoperative comfort.",2020,"RESULTS


PONV was significantly lower in the BIANB group (15.4 % VS 40 %, p = 0.049), as were mean VAS scores for pain (1 VS 1.57, p = 0.045) and medians of morphine bolus","['51 patients operated for bilateral sagittal split osteotomy (BSSO', 'mandibular osteotomy']","['bilateral inferior alveolar nerve block (BIANB', 'morphine bolus', 'bilateral inferior alveolar nerve block', 'bilateral inferior alveolar nerve block anesthesia at the start of surgery in addition to routine protocol']","['mean VAS scores for pain', 'nausea and vomiting and opioid and antiemetic consumption', 'PONV', 'postoperative nausea and vomiting (PONV), the visual analog scale (VAS) for pain, consumption of morphine (cumulative dose) and antiemetic agents, need for removal of guiding elastics', 'opioid consumption', 'incidence of guiding elastic removal, and antiemetic consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0616096', 'cui_str': 'BSSO'}, {'cui': 'C0185524', 'cui_str': 'Mandibulotomy'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block (procedure)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4285977', 'cui_str': 'Inferior alveolar nerve block anaesthesia'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",51.0,0.221942,"RESULTS


PONV was significantly lower in the BIANB group (15.4 % VS 40 %, p = 0.049), as were mean VAS scores for pain (1 VS 1.57, p = 0.045) and medians of morphine bolus","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vetter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Côte de Nacre University Hospital, 14 000, Caen Cedex, France. Electronic address: marjolainevetter@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chatellier', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Côte de Nacre University Hospital, 14 000, Caen Cedex, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maltezeanu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Côte de Nacre University Hospital, 14 000, Caen Cedex, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'De Mil', 'Affiliation': 'Normandie Univ, UNICAEN, INSERM, CHU de Caen, Anticipe, 14000, Caen, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bénateau', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Côte de Nacre University Hospital, 14 000, Caen Cedex, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Veyssière', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Côte de Nacre University Hospital, 14 000, Caen Cedex, France.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.02.012']
138,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND


Nitric oxide (NO) plays an important role in normal postnatal transition. Our aims were to determine whether adding inhaled NO (iNO) decreases supplemental oxygen exposure in preterm infants requiring positive pressure ventilation (PPV) during resuscitation and to study iNO effects on heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation during the first 20 min of life.
METHODS


This was a pilot, double-blind, randomized, placebo-controlled trial. Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled. PPV was initiated with either oxygen (FiO 2 -0.30) + iNO at 20 ppm (iNO group) or oxygen (FiO 2 -0.30) + nitrogen (placebo group). Oxygen was titrated targeting defined SpO 2  per current guidelines. After 10 min, iNO/nitrogen was weaned stepwise per protocol and terminated at 17 min.
RESULTS


Twenty-eight infants were studied (14 per group). The mean gestational age in both groups was similar. Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group. There were no differences in HR, SpO 2 , and need for intubation.
CONCLUSIONS


Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2  and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
139,32149879,Acute Effect of High-Intensity Interval Versus Moderate-Intensity Continuous Exercise on Blood Pressure and Arterial Compliance in Middle-Aged and Older Hypertensive Women With Increased Arterial Stiffness.,"Costa, EC, Kent, DE, Boreskie, KF, Hay, JL, Kehler, DS, Edye-Mazowita, A, Nugent, K, Papadopoulos, J, Stammers, AN, Oldfield, C, Arora, RC, Browne, RAV, and Duhamel, TA. Acute effect of high-intensity interval versus moderate-intensity continuous exercise on blood pressure and arterial compliance in middle-aged and older hypertensive women with increased arterial stiffness. J Strength Cond Res 34(5): 1307-1316, 2020-Hypertension and arterial stiffness are common in middle-aged and older women. This study compared the acute effect of high-intensity interval exercise (HIIE) and moderate-intensity continuous exercise (MICE) on blood pressure (BP) and arterial compliance in middle-aged and older hypertensive women with increased arterial stiffness. Nineteen women (67.6 ± 4.7 years) participated in this randomized controlled crossover trial. Subjects completed a control, MICE (30 minutes at 50-55% of heart rate reserve [HRR]), and HIIE (10 × 1 minute at 80-85% of HRR, 2 minutes at 40-45% of HRR) session in random order. Blood pressure and large and small arterial compliance (radial artery pulse wave analysis) were measured at baseline and 30, 60, 90, and 120 minutes after sessions. A p < 0.05 was considered statistically significant. Systolic BP was reduced in ∼10 mm Hg after MICE at 30 minutes and after HIIE at all time points (30, 60, 90, and 120 minutes) after exercise compared with the control session (p < 0.05). Only HIIE showed lower systolic BP levels at 60, 90, and 120 minutes after exercise compared with the control session (∼10 mm Hg; p < 0.05). No changes were observed in diastolic BP, or in large and small arterial compliance (p > 0.05). High-intensity interval exercise elicited a longer systolic postexercise hypotension than MICE compared with the control condition, despite the absence of acute modifications in large and small arterial compliance.",2020,"Only HIIE showed lower systolic BP levels at 60, 90, and 120 minutes after exercise compared with the control session (∼10 mm Hg; p < 0.05).","['middle-aged and older hypertensive women with increased arterial stiffness', 'middle-aged and older women', 'Middle-Aged and Older Hypertensive Women With Increased Arterial Stiffness', 'Nineteen women (67.6 ± 4.7 years', ' 000-000, 2020-Hypertension and arterial']","['high-intensity interval versus moderate-intensity continuous exercise', 'High-Intensity Interval', 'high-intensity interval exercise (HIIE) and moderate-intensity continuous exercise (MICE', 'J Strength Cond Res XX(X', 'Moderate-Intensity Continuous Exercise']","['systolic BP levels', 'Systolic BP', 'Blood Pressure and Arterial Compliance', 'diastolic BP, or in large and small arterial compliance', 'Blood pressure and large and small arterial compliance (radial artery pulse wave analysis', 'systolic postexercise hypotension', 'blood pressure and arterial compliance', 'blood pressure (BP) and arterial compliance', 'Costa, EC, Kent, DE, Boreskie, KF, Hay, JL, Kehler, DS, Edye-Mazowita, A, Nugent, K, Papadopoulos, J, Stammers, AN, Oldfield, C, Arora, RC, Browne, RAV, and Duhamel, TA']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026809', 'cui_str': 'Mice'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C2936233', 'cui_str': 'Postexercise Hypotension'}, {'cui': 'C0038131', 'cui_str': 'Stammering'}]",19.0,0.098584,"Only HIIE showed lower systolic BP levels at 60, 90, and 120 minutes after exercise compared with the control session (∼10 mm Hg; p < 0.05).","[{'ForeName': 'Eduardo C', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kent', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Boreskie', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Hay', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dustin S', 'Initials': 'DS', 'LastName': 'Kehler', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Edye-Mazowita', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Nugent', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Josaphine', 'Initials': 'J', 'LastName': 'Papadopoulos', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Stammers', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldfield', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Rakesh C', 'Initials': 'RC', 'LastName': 'Arora', 'Affiliation': 'Institute of Cardiovascular Sciences, St-Boniface Hospital Albrechtsen Research Center, Winnipeg, Canada.'}, {'ForeName': 'Rodrigo A V', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Duhamel', 'Affiliation': 'Health, Leisure & Human Performance Research Institute, Faculty of Kinesiology & Recreation Management, University of Manitoba, Winnipeg, Canada.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003552']
140,32187767,"""Take an HIV Test Kit Home"": A Pilot Randomized Controlled Trial Among HIV High-risk Urban ED Patients.",,2020,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"['people who inject drugs, men who have sex with men (MSM), and heterosexuals at increased risk, should be screened for HIV at least once annually and sexually active MSM from testing every 3-6 months', 'HIV High-Risk Urban ED Patients']",[],[],"[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.214878,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"[{'ForeName': 'Angie S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Anuj V', 'Initials': 'AV', 'LastName': 'Patel', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jett-Goheen', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Abrams', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'and the, Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rothman', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13968']
141,32187881,"Licogliflozin, a Novel SGLT1 and 2 Inhibitor: Body Weight Effects in a Randomized Trial in Adults with Overweight or Obesity.","OBJECTIVE


The aim of this study was to explore the dose response of licogliflozin, a dual inhibitor of sodium/glucose cotransporter 1 (SGLT1) and 2 (SGLT2), by evaluating change in body weight in adults with overweight or obesity.
METHODS


This dose-response analysis evaluated change in body weight following 24 weeks with four once-daily and twice-daily licogliflozin doses (2.5-150 mg) versus placebo (primary end point). A further 24-week analysis evaluated the efficacy and safety of two once-daily licogliflozin doses in maintaining initial weight reduction.
RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001). However, mean adjusted percent changes in body weight after 24 weeks were modest, ranging from -0.45% to -3.83% (in the 50 mg twice daily group [95% CI: -5.26% to -2.48%]; n = 75). Responder analysis of ≥ 5% weight loss at week 24 revealed significant differences versus placebo, which were most pronounced with highest doses of 50 mg twice daily (45.3%) and 150 mg once daily (42.9%) (both P < 0.01). While weight loss was greater at higher doses, gastrointestinal adverse events were also more frequent. The 50-mg once-daily dose had perhaps the best balance between efficacy and tolerability.
CONCLUSIONS


Licogliflozin produced significant reductions in body weight versus placebo. However, the magnitude of weight reduction was modest.",2020,"RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001).","['Adults with Overweight or Obesity', 'adults with overweight or obesity']","['licogliflozin, a dual inhibitor of sodium/glucose cotransporter 1 (SGLT1)\xa0and 2\xa0(SGLT2', 'placebo', 'Licogliflozin', 'licogliflozin']","['body weight', 'efficacy and tolerability', 'weight loss', 'efficacy and safety', 'gastrointestinal adverse events', 'weight reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0643053,"RESULTS


Licogliflozin once daily or twice daily produced a significant dose-response signal for weight loss versus placebo (P < 0.0001).","[{'ForeName': 'Harold E', 'Initials': 'HE', 'LastName': 'Bays', 'Affiliation': 'Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA.'}, {'ForeName': 'Plamen', 'Initials': 'P', 'LastName': 'Kozlovski', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Proot', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22764']
142,30424980,Three Nurse-administered Protocols Reduce Nutritional Decline and Frailty in Older Gastrointestinal Surgery Patients: A Cluster Randomized Trial.,"OBJECTIVE


To evaluate the effects of the modified Hospital Elder Life Program (mHELP) comprising 3 nurse-administered protocols in older patients undergoing gastrointestinal (GI) surgery.
DESIGN


Cluster randomized trial.
SETTING


Two 36-bed GI wards at a university-affiliated medical center in Taiwan.
PARTICIPANTS


Older patients (≥65 years, N = 377) were recruited if they were scheduled for elective GI surgery with an expected length of hospital stay >6 days. After transferring to the GI ward after surgery, participants were randomly assigned to the mHELP or control group (1:1) by room rather than individually because most patient units are double- or triple-occupancy rooms.
INTERVENTION


The mHELP protocols (early mobilization, oral and nutritional assistance, and orienting communication) were administered daily with usual care by a trained nurse until hospital discharge. The control group received usual care only.
MEASURES


Outcomes were in-hospital nutritional decline, measured by body weight and Mini-Nutritional Assessment (MNA) scores, and Fried's frailty phenotype. Return of GI motility was examined as a potential mechanism contributing to observed outcomes.
RESULTS


Participants (mean age = 74.5 years; 56.8% male) primarily underwent colorectal (56.5%), gastric (21.2%), and pancreatobiliary (13.8%) surgery. Participants who received the mHELP [for a median of 7 days (interquartile range = 6-10 days)] had significantly lower in-hospital weight loss and decline in MNA scores (weight -2.1 vs -4.0 lb, P = .002; score -3.2 vs -4.0, P = .03) than the control group. The mHELP group also had significantly lower rates of incident frailty during hospitalization (12.0% vs 21.7%, P = .022), and persistent frailty (50.0% vs 92.9%, P = .03). Participants in the mHELP group had trends toward an accelerated return of GI motility.
CONCLUSION AND IMPLICATIONS


The mHELP effectively reduced nutritional decline, prevented new frailty, and promoted recovery of frailty present before admission. These nurse-administered protocols might be useful in other settings, including conditions managed at home or in nursing facilities.",2019,"The mHELP effectively reduced nutritional decline, prevented new frailty, and promoted recovery of frailty present before admission.","['Older Gastrointestinal Surgery Patients', 'Participants (mean age\xa0', 'Older patients (≥65\xa0years, N\xa0=\xa0377) were recruited if they were scheduled for elective GI surgery with an expected length of hospital stay >6\xa0days', '74.5\xa0years; 56.8% male) primarily underwent colorectal (56.5%), gastric (21.2%), and pancreatobiliary (13.8%) surgery', 'Two 36-bed GI wards at a university-affiliated medical center in Taiwan', 'older patients undergoing gastrointestinal (GI) surgery']","['mHELP', 'modified Hospital Elder Life Program (mHELP', 'usual care only', 'mHELP or control group (1:1) by room rather than individually because most patient units are double- or triple-occupancy rooms']","['accelerated return of GI motility', ""hospital nutritional decline, measured by body weight and Mini-Nutritional Assessment (MNA) scores, and Fried's frailty phenotype"", 'rates of incident frailty during hospitalization', 'hospital weight loss and decline in MNA scores', 'persistent frailty']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0331055', 'cui_str': 'Elder Plant'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}]","[{'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",377.0,0.0494602,"The mHELP effectively reduced nutritional decline, prevented new frailty, and promoted recovery of frailty present before admission.","[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Chia-Hui Chen', 'Affiliation': 'Department of Nursing, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan. Electronic address: cherylchen@ntu.edu.tw.'}, {'ForeName': 'Yi-Ting', 'Initials': 'YT', 'LastName': 'Yang', 'Affiliation': 'Taiwan Center for Disease Control, Taipei, Taiwan.'}, {'ForeName': 'I-Rue', 'Initials': 'IR', 'LastName': 'Lai', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Been-Ren', 'Initials': 'BR', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ching-Yao', 'Initials': 'CY', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Wen', 'Initials': 'YW', 'LastName': 'Tien', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Nien', 'Initials': 'CN', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Tsan', 'Initials': 'MT', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jin-Tung', 'Initials': 'JT', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiu-Ching', 'Initials': 'HC', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, College of Medicine, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan; Department of Nursing, Sijhih Cathy General Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Guan-Hua', 'Initials': 'GH', 'LastName': 'Huang', 'Affiliation': 'Institute of Statistics, National Chiao Tung University, Hsinchu, Taiwan.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts; Institute for Aging Research, Hebrew Senior Life, Boston, Massachusetts.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.09.016']
143,32321714,"Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial.","PURPOSE


In contrast to the predominant chronic UV exposure-induced cutaneous melanoma in Caucasians, acral and mucosal comprise the majority of melanomas in Asia and respond less effectively to established treatments. The clinical application of PD-1 blockade is yet to be explored in metastatic melanoma in China.
PATIENTS AND METHODS


This phase II study was to evaluate safety and efficacy of toripalimab in advanced Chinese patients with melanoma who had failed in systemic treatments. Toripalimab was given at 3 mg/kg i.v. once every 2 weeks until disease progression or unacceptable toxicity. The primary objective was safety and objective response rate.
RESULTS


128 Patients with melanoma were enrolled, including 50 acral and 22 mucosal. As of August 15, 2019, 23 months after the last enrollment, 116 (90.6%) experienced treatment-related adverse events. ≥Grade 3 TRAEs occurred in 25 (19.5%) patients. Among 127 patients assessed, 1 complete response, 21 partial response, and 51 stable disease were observed for objective response rate of 17.3% and disease control rate of 57.5%. Median duration of response was not reached. Median progression-free survival was 3.6 months [95% confidence interval (CI) 2.7-5.3] and median overall survival was 22.2 months (95% CI, 15.3-NE). Patients with positive PD-L1 staining in tumor biopsies had significant better ORR (38.5% vs. 11.9%,  P  = 0.0065), PFS (7.7 months vs. 2.7 months,  P  = 0.013), and OS (not reached vs. 14.4 months,  P  = 0.0005) than PD-L1-negative patients.
CONCLUSIONS


This is the largest prospective anti-PD-1 clinical study in advanced melanoma with predominantly acral and mucosal subtypes. Toripalimab demonstrated a manageable safety profile and durable clinical response in Chinese patients with metastatic melanoma refractory to standard therapy. See related commentary by Shoushtari et al., p. 4171 .",2020,"Patients with positive PD-L1 staining in tumor biopsies had significant better ORR (38.5% versus 11.9%, p=0.0065), PFS (7.7m versus 2.7m, p=0.013) and OS (not reached versus 14.4m, p=0.0005) than PD-L1 negative patients.
","['128 melanoma patients were enrolled, including 50 acral and 22 mucosal', 'previously treated advanced melanoma', 'advanced melanoma with predominantly acral and mucosal subtypes', 'advanced Chinese melanoma patients who had failed in systemic treatments', 'metastatic melanoma in China', 'Chinese patients with metastatic melanoma refractory to standard therapy']","['toripalimab', 'Toripalimab']","['OS', 'PFS', 'Median progression-free survival', 'treatment-related adverse events', '3 TRAEs', 'safety and objective response rate', 'safety and efficacy', 'ORR', 'median overall survival', 'Median duration of response', 'objective response rate', 'manageable safety profile and durable clinical response']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439746', 'cui_str': 'Acral'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],"[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.28348,"Patients with positive PD-L1 staining in tumor biopsies had significant better ORR (38.5% versus 11.9%, p=0.0065), PFS (7.7m versus 2.7m, p=0.013) and OS (not reached versus 14.4m, p=0.0005) than PD-L1 negative patients.
","[{'ForeName': 'Bixia', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Chi', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Tumor Hospital of Yunnan Province & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center, Kunming, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'OrigiMed, Shanghai, China.'}, {'ForeName': 'Lihou', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Shanghai Junshi Biosciences Co., LTD, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Shanghai Junshi Biosciences Co., LTD, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Shanghai Junshi Biosciences Co., LTD, Shanghai, China.'}, {'ForeName': 'Shuikui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'Xiaoshi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China. guoj307@126.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3922']
144,32319673,"Neuronavigation-Guided rTMS for the Treatment of Depressive Patients With Suicidal Ideation: A Double-Blind, Randomized, Sham-Controlled Trial.","During the last decade, the problem of suicide has become more serious in individuals with depression. Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD). This study aims to investigate the efficacy of magnetic resonance imaging (MRI)-based neuronavigation-guided daily high-dose rTMS for rapidly improving suicidal ideation in treatment-naive patients with MDD. In the present 1-week double-blind study, 42 treatment-naive patients with MDD with suicidal ideation were randomly assigned to the treatment of escitalopram oxalate tablets (10 mg/d) in combination with either active (n = 21) or sham (n = 21) rTMS. The TMS coil was positioned over a specified target location (-44, 40, and 29) in left dorsolateral prefrontal cortex based on MRI data. The severity of suicidal ideation was measured by the Beck Scale for Suicide Ideation (BSI). The 24-item Hamilton Depression Rating Scale (HAMD-24) and Montgomery-Åsberg Depression Rating Scale (MADRS) were utilized to assess the severity of depression. The Wisconsin Card Sorting Test, Continuous Performance Test, and Stroop Color-Word Test were adopted to assess executive function. In contrast to the sham group, the active rTMS group showed a significantly greater BSI score reduction at the third day and the seventh day (P < 0.001). Moreover, the active rTMS group showed a significantly greater HAMD (P < 0.001) and MADRS (P < 0.001) score reduction at the seventh day in comparison to the sham group. The present findings suggested that the neuronavigation-guided high-dose rTMS may be a novel method to rapidly reduce suicidal ideation and mitigate depressive symptoms.",2020,"Moreover, the active rTMS group showed a significantly greater HAMD (p < 0.001) and MADRS (p < 0.001) score reduction at the seventh day in comparison with the sham group.","['major depressive disorder (MDD', '42 treatment-naive MDD patients with suicidal ideation', 'individuals with depression', 'depressive patients with suicidal ideation', 'treatment-naive MDD patients']","['Repetitive transcranial magnetic stimulation (rTMS', 'MRI-based neuronavigation-guided daily high-dose rTMS', 'escitalopram oxalate tablets (10 mg/d) in combination with either active (n = 21) or sham (n = 21) rTMS', 'Neuronavigation-guided rTMS']","['HAMD', 'suicidal ideation', 'severity of suicidal ideation', 'Wisconsin Card Sorting Test (WCST), Continuous Performance Test (CPT) and Stroop Color-Word Test (SCWT', '24-item Hamilton Depression Rating Scale (HAMD-24) and Montgomery-Asberg Depression Rating Scale (MADRS', 'Beck Scale for Suicide Ideation', 'BSI score reduction', 'MADRS', 'suicidal ideation and mitigate depressive symptom']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",42.0,0.0772028,"Moreover, the active rTMS group showed a significantly greater HAMD (p < 0.001) and MADRS (p < 0.001) score reduction at the seventh day in comparison with the sham group.","[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'JianPing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinkai', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shangda', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Desheng', 'Initials': 'D', 'LastName': 'Shang', 'Affiliation': ""Department of Radiology, First Affiliated Hospital, College of Medicine, The Key Laboratory of Mental Disorder's Management of Zhejiang Province, Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1858']
145,31577671,Randomized Sirolimus-based Early Calcineurin Inhibitor Reduction in Liver Transplantation: Impact on Renal Function.,"BACKGROUND


The long-term use of calcineurin inhibitors (CNIs) after liver transplantation (LT) is associated with nephrotoxicity.
METHODS


Five-year follow-up data were retrieved from the randomized controlled multicenter SiLVER trial. Standard CNI-based mammalian target of rapamycin-free immunosuppression (group A, n = 264) was compared with a 50% reduction of CNI and introduction of the mammalian target of rapamycin inhibitor Sirolimus (SIR) within 4-6 weeks after LT (group B, n = 261).
RESULTS


Median MELD at LT was low with 10 (7-15) (group A) and 11 (8-15) (group B) in the intention-to-treat approach. CNI dose and CNI trough were reduced by 20% and 8% (group A) versus 55% and 56% (group B) at 3 months posttransplantation. Renal function was preserved at 3 months after LT in the SIR arm (estimated glomerular filtration rate 74 [57-95] versus 67 [55-85] mL/min/1.73m2 P = 0.004) but was similarly impaired thereafter compared with group A. The per protocol analysis identified LT recipients in group B with concomitant early CNI minimization and SIR treatment ≥ year 1 with significantly superior estimated glomerular filtration rate and lowest rate of chronic kidney disease (≥stage 3) from year 1 onwards until study end. Competing risk factors for renal disease (arterial hypertension, fat metabolism disorder, and hyperglycemia) were not associated with worse kidney function.
CONCLUSIONS


Prevention of CNI nephrotoxicity by SIR-based early CNI minimization protects renal function only short-term after LT in the intention-to-treat analysis of this low MELD cohort. Yet, selected LT recipients compliant with early CNI minimization and SIR maintenance achieved better long-term renal outcomes compared with real-world practice.",2020,"Competing risk factors for renal disease (arterial hypertension, fat metabolism disorder and hyperglycemia) were not associated with worse kidney function.
","['5-year follow-up data', 'liver transplantation']","['Standard CNI-based mTOR-free immunosuppression', 'calcineurin inhibitors (CNI) after liver transplantation (LT', 'Sirolimus-based early calcineurin inhibitor reduction', 'mTOR inhibitor Sirolimus', 'Sirolimus-based early CNI minimization']","['Renal function', 'CNI dose and CNI trough', 'renal disease (arterial hypertension, fat metabolism disorder and hyperglycemia']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",,0.102055,"Competing risk factors for renal disease (arterial hypertension, fat metabolism disorder and hyperglycemia) were not associated with worse kidney function.
","[{'ForeName': 'Bettina M', 'Initials': 'BM', 'LastName': 'Buchholz', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Ferguson', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Schnitzbauer', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital, Goethe-University Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Institute of Translational Medicine (ITM), University Hospitals Birmingham NHS Foundation Trust, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Geissler', 'Affiliation': 'Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'Darius F', 'Initials': 'DF', 'LastName': 'Mirza', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000002980']
146,31349916,Randomized Trial of 42-Day Compared with 9-Day Courses of Dexamethasone for the Treatment of Evolving Bronchopulmonary Dysplasia in Extremely Preterm Infants.,"OBJECTIVE


To compare pulmonary and neurodevelopmental outcomes in extremely preterm infants with evolving bronchopulmonary dysplasia treated with either a 42-day course of dexamethasone or 9-day course(s) of dexamethasone.
STUDY DESIGN


This was a prospective, randomized study in 59 infants ≤27 weeks of gestation born between October 2006 and December 2010, who at day 10-21 of life had ventilatory support with mean airway pressure ≥8 cm H 2 O and FiO 2  ≥60%. Infants received dexamethasone 0.5 mg/k/day × 3 days followed by a slow taper (42-day group, n = 30) or dexamethasone 0.5 mg/k/day followed by a rapid taper (9-day group, n = 29). Infants in the 9-day group received additional 9-day courses if they again required entry support. The primary outcome was intact survival (normal neurologic examination, IQ >70, and functioning in school without supplemental educational support) at 7 years of age.
RESULTS


The 42-day and 9-day groups were similar for mean gestational age (25 weeks) and all baseline characteristics. Nineteen of 29 infants (66%) in the 9-day group received only 1 course of dexamethasone; therefore, the total steroid dose for the 42-day group (7.56 mg/kg) was significantly greater than that for the 9-day group (4.04 mg/kg), P < .001. Infants in the 42-day group had shorter duration of ventilation (25 vs 37 days), P < .005, received fewer transfusions (2 vs 3.5), P < .01, and reached full enteral feeds earlier (40 vs 46 days), P < .05. Intact survival at school age was significantly increased in the 42-day group (75%) compared with the 9-day group (34%), P < .005.
CONCLUSION


A 42-day tapering course of dexamethasone in extremely preterm infants at high risk for bronchopulmonary dysplasia decreased hospital morbidities and increased rate of survival without handicap compared with a treatment protocol that attempted to minimize steroid exposure.",2019,"Infants in the 42-day group had shorter duration of ventilation (25 vs 37 days), P < .005, received fewer transfusions (2 vs 3.5), P < .01, and reached full enteral feeds earlier (40 vs 46 days), P < .05.","['59 infants ≤27\xa0weeks of gestation born between October 2006 and December 2010, who at day 10-21 of life had ventilatory support with mean airway pressure', 'extremely preterm infants at high risk for bronchopulmonary dysplasia', 'Extremely Preterm Infants', 'extremely preterm infants with evolving bronchopulmonary dysplasia treated with either a 42-day course of dexamethasone or 9-day course(s) of']","['dexamethasone', 'Dexamethasone', 'dexamethasone 0.5\xa0mg/k/day followed by a rapid taper', 'dexamethasone 0.5\xa0mg/k/day']","['hospital morbidities', 'shorter duration of ventilation', 'Intact survival at school age', 'rate of survival without handicap', 'intact survival (normal neurologic examination, IQ >70, and functioning in school without supplemental educational support']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0332253', 'cui_str': 'Evolving (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0985342', 'cui_str': 'Dexamethasone 0.5 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",,0.291652,"Infants in the 42-day group had shorter duration of ventilation (25 vs 37 days), P < .005, received fewer transfusions (2 vs 3.5), P < .01, and reached full enteral feeds earlier (40 vs 46 days), P < .05.","[{'ForeName': 'Bonnie L', 'Initials': 'BL', 'LastName': 'Marr', 'Affiliation': 'Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY; Department of Neonatology, Crouse Hospital, Syracuse, NY. Electronic address: bonniemarrmd@crouse.org.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Mettelman', 'Affiliation': 'Department of Neonatology, Crouse Hospital, Syracuse, NY.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Bode', 'Affiliation': 'Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY; Department of Neonatology, Crouse Hospital, Syracuse, NY.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gross', 'Affiliation': 'Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY; Department of Neonatology, Crouse Hospital, Syracuse, NY.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.04.047']
147,32315497,"Pharmacodynamic Effects of Topical Omiganan in Patients With Mild to Moderate Atopic Dermatitis in a Randomized, Placebo-Controlled, Phase II Trial.","Omiganan is an indolicidin analog with antimicrobial properties that could be beneficial for patients with atopic dermatitis. In this randomized, double-blind, placebo-controlled, phase II trial we explored the efficacy, pharmacodynamics, and safety of topical omiganan once daily in 36 patients with mild to moderate atomic dermatitis. Patients were randomized to apply topical omiganan 1%, omiganan 2.5%, or vehicle gel to one target lesion once daily for 28 consecutive days. Small but significant improvements in local objective SCORing Atopic Dematitis index and morning itch were observed in the omiganan 2.5% group compared with the vehicle gel group (-18.5%; 95% confidence interval, -32.9 to -1.0; P = 0.04; and -8.2; 95% confidence interval, -16.3 to -0.2; P = 0.05, respectively). A shift from lesional to nonlesional skin microbiota was observed in both omiganan treatment groups, in contrast to the vehicle group. Thus, treatment with topical omiganan improved dysbiosis in patients with mild to moderate atopic dermatitis, and small but statistically significant improvements in clinical scores were detected. Our findings warrant further exploration in future clinical trials.",2020,"Small but significant improvements of the local oSCORAD index and morning itch were observed in the omiganan 2.5% group compared to the vehicle gel group (-18.5%; 95%CI=-32.9,-1.0; p=0.04 and -8.2; 95%CI=-16.3,-0.2; p=0.05 respectively).","['36 patients with mild to moderate AD', 'patients with mild to moderate atopic dermatitis', 'patients with atopic dermatitis']","['omiganan 2.5% or vehicle gel', 'topical omiganan', 'placebo']","['local oSCORAD index and morning itch', 'lesional skin microbiota', 'Pharmacodynamic effects', 'clinical scores', 'efficacy, pharmacodynamics and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C4550028', 'cui_str': 'Omiganan'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",36.0,0.310383,"Small but significant improvements of the local oSCORAD index and morning itch were observed in the omiganan 2.5% group compared to the vehicle gel group (-18.5%; 95%CI=-32.9,-1.0; p=0.04 and -8.2; 95%CI=-16.3,-0.2; p=0.05 respectively).","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Niemeyer-van der Kolk', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'van der Wall', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Geretta K', 'Initials': 'GK', 'LastName': 'Hogendoorn', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'Rijneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Luijten', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Dirk C J G', 'Initials': 'DCJG', 'LastName': 'van Alewijk', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, The Netherlands.'}, {'ForeName': 'Ellen H A', 'Initials': 'EHA', 'LastName': 'van den Munckhof', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, The Netherlands.'}, {'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'de Kam', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Feiss', 'Affiliation': 'Cutanea Life Sciences, Wayne, Pennsylvania, USA.'}, {'ForeName': 'Errol P', 'Initials': 'EP', 'LastName': 'Prens', 'Affiliation': 'Department of Dermatology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Martijn B A', 'Initials': 'MBA', 'LastName': 'van Doorn', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Clinical and translational science,['10.1111/cts.12792']
148,32323557,"Vitamin D Treatment Attenuates Heart Apoptosis After Coronary Artery Bypass Surgery: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.","BACKGROUND


Vitamin D plays an important role in immune system and in the regulation of inflammatory cytokines. Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is associated with an extensive inflammatory response. The aim of this study is to examine the effect of vitamin D treatment on the apoptosis and inflammatory changes developed after CABG.
METHODS


This trial was conducted on 70 patients undergoing CABG with CPB. Patients were randomly administered either in placebo or in the group of orally consuming 150 000 IU vitamin D daily for 3 consecutive days before surgery. The right atrium sample was taken to assess caspases 2, 3, and 7 activity using immunohistochemistry method. The serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1) were compared at intervals.
RESULTS


The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively). There was an increase in serum levels of IL-10 after 3 days from vitamin D treatment before surgery (vitamin D group = 4.4 ± 4.9 ng/mL and control group = 1 ± 0.5 ng/mL,  P  = .001). After operation, IL-10 increased in both groups, higher level in vitamin D group ( P  < .001). The comparison of serum IGF-1 showed significant difference after 3 days ( P  = .006) and remained higher in vitamin D group after CPB ( P  < .001).
CONCLUSIONS


These findings suggest the apoptosis rate after CPB can be reduced by vitamin D. Vitamin D treatment may improve the inflammatory status before and after surgery. Further studies are needed to confirm the antiapoptotic property of vitamin D and clinical implication.",2020,"The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively).",['70 patients undergoing CABG with CPB'],"['Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB', 'Coronary Artery Bypass Surgery', 'vitamin D. Vitamin D', 'Placebo', 'placebo', 'Vitamin D', 'vitamin D']","['serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1', 'average number of positive cells', 'Heart Apoptosis', 'IL-10', 'apoptosis rate', 'serum levels of IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",70.0,0.638586,"The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P  = .006 and  P  < .001, respectively).","[{'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Tasdighi', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Hekmat', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Beheshti', 'Affiliation': 'Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Baghaei', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohsen', 'Initials': 'SM', 'LastName': 'Mirhosseini', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Torbati', 'Affiliation': 'Department of Pathology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Pourmotahari', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnoosh', 'Initials': 'M', 'LastName': 'Foroughi', 'Affiliation': 'Clinical Research and Development Center, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420920495']
149,32304404,Stress Management Training Improves Overall Performance during Critical Simulated Situations: A Prospective Randomized Controlled Trial.,"BACKGROUND


High-fidelity simulation improves participant learning through immersive participation in a stressful situation. Stress management training might help participants to improve performance. The hypothesis of this work was that Tactics to Optimize the Potential, a stress management program, could improve resident performance during simulation.
METHODS


Residents participating in high-fidelity simulation were randomized into two parallel arms (Tactics to Optimize the Potential or control) and actively participated in one scenario. Only residents from the Tactics to Optimize the Potential group received specific training a few weeks before simulation and a 5-min reactivation just before beginning the scenario. The primary endpoint was the overall performance during simulation measured as a composite score (from 0 to 100) combining a specific clinical score with two nontechnical scores (the Ottawa Global Rating Scale and the Team Emergency Assessment Measure scores) rated for each resident by four blinded independent investigators. Secondary endpoints included stress level, as assessed by the Visual Analogue Scale during simulation.
RESULTS


Of the 134 residents randomized, 128 were included in the analysis. The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]). After specific preparation, the median Visual Analogue Scale was 17% lower in the Tactics to Optimize the Potential group (52 [42 to 64]) than in the control group (63 [50 to 73]; difference, -10 [95% CI, -16 to -3]; P = 0.005; effect size, 0.44 [95% CI, 0.26 to 0.59].
CONCLUSIONS


Residents coping with simulated critical situations who have been trained with Tactics to Optimize the Potential showed better overall performance and a decrease in stress level during high-fidelity simulation. The benefits of this stress management training may be explored in actual clinical settings, where a 5-min Tactics to Optimize the Potential reactivation is feasible prior to delivering a specific intervention.",2020,"The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]).","['Residents participating in high-fidelity simulation', '134 residents randomized', 'during Critical Simulated Situations']","['specific training', 'Stress management training', 'Stress Management Training', 'stress management training']","['median Visual Analogue Scale', 'overall performance (mean ± SD', 'stress level, as assessed by the Visual Analogue Scale during simulation', 'stress level', 'Overall Performance', 'overall performance during simulation measured as a composite score (from 0 to 100) combining a specific clinical score with two nontechnical scores (the Ottawa Global Rating Scale and the Team Emergency Assessment Measure scores) rated']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",134.0,0.0838857,"The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]).","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Sigwalt', 'Affiliation': 'From the Departments of Anesthesia and Intensive Care, Hospices Civils of Lyon, Lyon, France (F.S., G.P., D.C., J.-J.L., T.R., M.L.) Departments of Anesthesia and Intensive Care, Grenoble Alpes University Hospital, Grenoble, France (J.-N.E.) Institute of Biomedical Research, Armies\' Health Service, Bretigny sur Orge, France (D.C., M.T., F.C.) Desgenettes Hospital, Armies\' Health Service, Lyon, France (M.B.) Seventh Medical Center of the Armies of Lyon, 76th Medical Antenna of Varces, Varces, France (A.G.-L.) Claude Bernard Lyon 1 University, high fidelity medical simulation center (CLESS; Centre Lyonnais d\'Enseignement par Simulation en Santé), SAMSEI, Lyon, France (D.C., J.-J.L., T.R., M.L.) Health Data Department, Hospices Civils of Lyon, Lyon, France (A.D.) Claude Bernard Lyon 1 University, Health Services and Performance Research Lab (EA 7425 HESPER), Lyon, France (A.D., J.-J.L., M.L.) EA 7426 ""Pathophysiology of Injury-Induced Immunosuppression"" (Pi3), Claude Bernard Lyon 1 University-Biomérieux-Hospices Civils of Lyon, Lyon, France (T.R.) Val-de-Grâce School, Paris, France (M.T., F.C.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Petit', 'Affiliation': ''}, {'ForeName': 'Jean-Noel', 'Initials': 'JN', 'LastName': 'Evain', 'Affiliation': ''}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Claverie', 'Affiliation': ''}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Bui', 'Affiliation': ''}, {'ForeName': 'Angélique', 'Initials': 'A', 'LastName': 'Guinet-Lebreton', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Trousselard', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Canini', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Chassard', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Duclos', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Lehot', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmelé', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lilot', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003287']
150,32304405,"Magnesium and Bladder Discomfort after Transurethral Resection of Bladder Tumor: A Randomized, Double-blind, Placebo-controlled Study.","BACKGROUND


Catheter-related bladder discomfort occurs because of involuntary contractions of the bladder smooth muscle after urinary catheterization. Magnesium is associated with smooth muscle relaxation. This study hypothesized that among patients having transurethral resection of bladder tumor, magnesium will reduce the incidence of postoperative moderate-to-severe catheter-related bladder discomfort.
METHODS


In this double-blind, randomized study, patients were randomly allocated to the magnesium group (n = 60) or the control group (n = 60). In magnesium group, a 50 mg/kg loading dose of intravenous magnesium sulfate was administered for 15 min, followed by an intravenous infusion of 15 mg · kg · h during the intraoperative period. Patients in the control group similarly received normal saline. The primary outcome was the incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively. None, mild, moderate, and severe catheter-related bladder discomfort at 1, 2, and 6 h postoperatively, patient satisfaction, and magnesium-related adverse effects were also assessed.
RESULTS


The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively). Patient satisfaction on a scale from 1 to 7 was significantly higher in the magnesium group than in the control group (5.1 ± 0.8 vs. 3.5 ± 1.0; P < 0.001; 95% CI, 1.281 to 1.919). Magnesium-related adverse effects were not significantly different between groups.
CONCLUSIONS


Magnesium reduced the incidence of catheter-related bladder discomfort above a moderate grade and increased patient satisfaction among patients having transurethral resection of bladder tumor.",2020,"The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively).","['after Transurethral Resection of Bladder Tumor', '120 patients recovering from transurethral resection of bladder tumor, intravenous', 'patients having transurethral resection of bladder tumor']","['magnesium', 'intravenous magnesium sulfate', 'normal saline', 'Magnesium', 'Placebo', 'Magnesium and Bladder Discomfort']","['patient satisfaction, and magnesium-related adverse effects', 'incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively', 'patient satisfaction', 'Magnesium-related adverse effects', 'bladder discomfort', 'Patient satisfaction', 'catheter-related bladder discomfort', 'mild, moderate, and severe catheter-related bladder discomfort', 'incidence of catheter-related bladder discomfort']","[{'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",120.0,0.63529,"The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively).","[{'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (J.-Y.P.. D.-H.K., J.Y., J.-H.H., Y.-K.K.) the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (J.H.H.).'}, {'ForeName': 'Jun Hyuk', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jihion', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jai-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Young-Kug', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003309']
151,32127304,3D planning in mandibular fractures using CAD/CAM surgical splints - A prospective randomized controlled clinical trial.,"This randomized controlled trial assessed the role of CAD/CAM splints in achieving anatomic reduction of fractured fragments and ideal occlusion, in comparison with conventional splints. Patients diagnosed with displaced mandibular fracture and post-traumatic malocclusion were allocated to study and control groups by simple randomization. A standardized surgical approach was followed to expose the fractures. Reduction of fractures was carried out using CAD/CAM and conventional splints in the study and control groups, respectively. The parameters assessed were: occlusion, interfragmentary separation, fit of the splint, patient comfort, and surgeon comfort. Mann-Whitney U tests were used to compare the study and control groups. To compare the groups pre- and post-intervention Wilcoxon signed rank tests were used. Chi-square tests were applied for proportion comparisons. The sample consisted of 30 patients. The study group demonstrated superior clinical outcomes with regards to intraoperative reduction of fracture (p < 0.001; mean - 3.93, SD - 1.43), and to achieving intraoperative occlusion (p = 0.483) and postoperative occlusion (p = 0.224). Statistically significant improvements in both patient comfort (p < 0.001; mean - 0.20, SD - 0.41) and surgeon comfort (p < 0.001) were found in the study group. In conclusion, CAD/CAM splints improve precision in fracture reduction and restoration of occlusion through a simple fabrication process.",2020,"The study group demonstrated superior clinical outcomes with regards to intraoperative reduction of fracture (p < 0.001; mean - 3.93, SD - 1.43), and to achieving intraoperative occlusion (p = 0.483) and postoperative occlusion (p = 0.224).","['Patients diagnosed with displaced mandibular fracture and post-traumatic malocclusion', 'mandibular fractures using CAD/CAM surgical splints']","['pre- and post-intervention', 'CAD/CAM splints', '3D planning']","['postoperative occlusion', 'achieving intraoperative occlusion', 'intraoperative reduction of fracture', 'occlusion, interfragmentary separation, fit of the splint, patient comfort, and surgeon comfort', 'surgeon comfort', 'patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]",30.0,0.0526952,"The study group demonstrated superior clinical outcomes with regards to intraoperative reduction of fracture (p < 0.001; mean - 3.93, SD - 1.43), and to achieving intraoperative occlusion (p = 0.483) and postoperative occlusion (p = 0.224).","[{'ForeName': 'Mrunalini', 'Initials': 'M', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Ramapuram, Chennai, 600089, Tamil Nadu, India.'}, {'ForeName': 'Elavenil', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Ramapuram, Chennai, 600089, Tamil Nadu, India. Electronic address: elavenilomfs@gmail.com.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Krishna Kumar Raja', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Ramapuram, Chennai, 600089, Tamil Nadu, India.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.02.004']
152,31509072,Condom Use for Sexually Transmitted Infection Prevention Among Hispanic Teenage Mothers: A Community-Based Randomized Trial.,"Background:  Hispanics experience a higher prevalence of sexually transmitted infections (STIs) than non-Hispanics. Specifically, Hispanic teenagers are more at risk for HIV, have close to four times the rate of primary and secondary syphilis, and close to two times the rate of chlamydia and gonorrhea compared with non-Hispanic white teenagers. Hispanic youth engage in sexual activity at a younger age than non-Hispanic white youth and are less likely to use condoms in these encounters, thereby contributing to increased rates of teenage pregnancy and STIs. Prevention of STIs is needed for unmarried Hispanic teenage mothers. The purpose of this study was to examine whether Project Mothers and Schools (Project MAS), a support program for parenting teenagers, changed condom use to prevent STIs among Hispanic participants.  Methods:  A longitudinal study was conducted among 84 Hispanic teenage mothers. Generalized estimating equations were used to identify factors associated with participants' reported condom use to prevent STIs.  Results:  Overall, participants were 3.21 times more likely to report condom use to prevent STIs from baseline to 12-month follow-up ( p  = 0.030). Those using condoms to prevent pregnancy at 12-month follow-up were significantly more likely to report using a condom to prevent STIs (OR = 3.23,  p  = 0.017).  Conclusions:  Participation in Program MAS improved condom use patterns for STI prevention. These services and supports have potential to change unmarried Hispanic teenage mothers' condom use behaviors and decrease STI infection disparities among the teenage Hispanic population.",2020,"Those using condoms to prevent pregnancy at 12-month follow-up were significantly more likely to report using a condom to prevent STIs (OR = 3.23,  p  = 0.017).  ","['Hispanic youth engage in sexual activity at a younger age than non-Hispanic white youth', 'unmarried Hispanic teenage mothers', 'Sexually Transmitted Infection Prevention', '84 Hispanic teenage mothers', 'Hispanic Teenage Mothers', 'Project Mothers and Schools (Project MAS), a support program for parenting teenagers, changed condom use to prevent STIs among Hispanic participants', 'Hispanic teenagers']",['STIs'],['rate of chlamydia and gonorrhea'],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}]","[{'cui': 'C0036916', 'cui_str': 'STDs'}]","[{'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}]",,0.0556268,"Those using condoms to prevent pregnancy at 12-month follow-up were significantly more likely to report using a condom to prevent STIs (OR = 3.23,  p  = 0.017).  ","[{'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Center for Population Health and Aging, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Wilson', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Caroline D', 'Initials': 'CD', 'LastName': 'Bergeron', 'Affiliation': 'Institut national de santé publique du Québec, Quebec, Canada.'}]",Journal of women's health (2002),['10.1089/jwh.2018.7455']
153,30370852,Efficacy of a Herbal Formulation Based on  Foeniculum Vulgare  in Oligo/Amenorrhea: A Randomized Clinical Trial.,"BACKGROUND


The aim of this study was to evaluate the efficacy of the herbal tea based on Foeniculum vulgare, on inducing regular bleeding in women with oligomenorrhea and secondary amenorrhea( oligo/amenorrhea).
METHODS


Forty women aged 18- 40 with oligo/amenorrhea were enrolled in this randomized controlled clinical trial and were allocated to two groups equally. The women in the first group were treated by Fomentex (Foeniculum vulgare / Mentha longifolia / Vitex agnus-castus) herbal tea 11.2 g/day in 2 divided doses for 2 weeks and the second group were treated by medroxy progesterone acetate (MP)10 mg/day for the last 10 days of their menstrual cycles. The intervention was repeated in three cycles of menstruation in both groups. Bleeding pattern was documented by the patient on diary cards. The occurrence (yes/no) of bleeding, the regularity of bleeding pattern, the interval of cycles, the duration of bleeding, the volume of blood flow, the hormonal parameters (total testosterone, free testosterone luteinizing hormone and follicle-stimulating hormone), and the endometrial thickness in sonography before and after the intervention were evaluated and compared as outcomes.
RESULTS


The number of women with bleeding during the first cycle was in the Fomentex group and the MP group 83.3% and 94.1% respectively (p = 0.61). The regularity of bleeding did not significantly differ in patients treated with Fomentex from those given MP (66.7% vs. 94.1%; p = 0.088). Mean interval of cycles decreased in both groups after intervention (P<0.001). Mean duration decreased significantly in MP group after the intervention but it was not different in patients treated with Fomentex. The difference between 2 groups was not significant (P=0.705). Volume of blood flow, with regard to Pictorial Blood Assessment Chart (PBAC), increased significantly in MP group after the intervention (P=0.001) and it was not different in patients treated with Fomentex (P=0.757); however, difference between 2 groups was not significant (P=0.063). The percentage of patients with on time menstruation in the next (drug-free) episode, was higher in the Fomentex group compared with the MP group (50% vs. 23.5%; p = 0.105). Secondary outcomes such as dysmenorrhea, acne and hirsutism reduced in the Fomentex group (P≤0.05), while they increased in the MP group (P=0.007). At the end of the treatment, there was a significant decrease in luteinizing hormone, total testosterone and free testosterone in patients taking Fomentex. The decrease of endometrial thickness, was significant in both groups after the intervention (P=0.001), but the difference between 2 groups was not significant (P=0.58). No notable complication or side effect was reported in relation to Fomentex.
CONCLUSION


Fomentex herbal tea is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with oligo/amenorrhea.",2020,"The decrease of endometrial thickness, was significant in both groups after the intervention (P=0.001), but the difference between 2 groups was not significant (P=0.58).","['Amenorrhea', 'women with oligomenorrhea and secondary amenorrhea(oligo/amenorrhea', 'Forty women aged 18- 40 with oligo/amenorrhea', 'women with oligo/amenorrhea']","['Herbal Formulation', 'medroxy progesterone acetate (MP)10', 'Fomentex herbal tea', 'herbal tea', 'Fomentex (Foeniculum vulgare ']","['Bleeding pattern', 'Mean interval of cycles', 'Mean duration', 'time menstruation', 'notable complication or side effect', 'regularity of bleeding', 'dysmenorrhea, acne and hirsutism', 'endometrial thickness', 'Volume of blood flow, with regard to Pictorial Blood Assessment Chart (PBAC', 'number of women with bleeding', 'occurrence (yes/no) of bleeding, the regularity of bleeding pattern, the interval of cycles, the duration of bleeding, the volume of blood flow, the hormonal parameters (total testosterone, free testosterone luteinizing hormone and follicle-stimulating hormone), and the endometrial thickness in sonography', 'luteinizing hormone, total testosterone and free testosterone']","[{'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028949', 'cui_str': 'Oligomenorrhea'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1137305', 'cui_str': 'oligo(caprolactone)'}]","[{'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0019233', 'cui_str': 'Tisanes'}, {'cui': 'C0553175', 'cui_str': 'Foeniculum vulgare'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449581', 'cui_str': 'Regularity (attribute)'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}]",40.0,0.0407092,"The decrease of endometrial thickness, was significant in both groups after the intervention (P=0.001), but the difference between 2 groups was not significant (P=0.58).","[{'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Falahat', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Ayatiafin', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Jarahi', 'Affiliation': 'Community Medicine Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mokaberinejad', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Rakhshandeh', 'Affiliation': 'Pharmacological Research Center of Medicinal Plants, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Feyzabadi', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Tavakkoli', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Current drug discovery technologies,['10.2174/1570163815666181029120512']
154,31186260,Design and Outcomes of a Community Trial to Increase Pap Testing in Pacific Islander Women.,"BACKGROUND


Pap tests remain an essential cervical cancer detection method in the United States, yet they are underutilized among Pacific Islanders (PI) who experience elevated cervical cancer incidence and mortality. This study describes the design, methods, participants, and outcomes of a multiyear (2010-2016), community-based randomized intervention trial in southern California. Based upon strong collectivistic norms, the trial tested the efficacy of a unique social support intervention targeting Chamorro, Samoan, and Tongan women and their male husbands/partners.
METHODS


A single-session educational intervention was designed and tailored for ethnic- and gender-specific groups to increase men's social support for their female wives/partners to receive a Pap test, and for women to receive a Pap test. The comparison group received preexisting brochures on Pap testing (for women) or general men's health (for men). Pretest and 6-month follow-up data were analyzed.
RESULTS


Intervention and comparison groups were mostly equivalent on pretest demographics and outcome variables. Intervention women who were not compliant with Pap screening recommendations at pretest were significantly more likely to have scheduled and received a Pap test at 6-month follow-up. However, 6-month follow-up results indicated no intervention effect on changes in women's Pap testing knowledge, fatalistic attitudes, or perceived social support from their male partner.
CONCLUSIONS


Ethnic- and gender-tailored community interventions can successfully increase Pap test behaviors for PI women, although more research is needed on the specific pathways leading to behavior change.
IMPACT


Collaborative community-based interventions lead to increases in women's cancer prevention and early detection for Pacific Islander and other collectivistic communities.",2019,"IMPACT


Collaborative community-based interventions lead to increases in women's cancer prevention and early detection for Pacific Islander and other collectivistic communities.","['Intervention women who were not compliant with Pap screening recommendations at pre-test', ""women's cancer prevention and early detection for Pacific Islander and other collectivistic communities"", 'PI women', 'Pacific Islander Women', 'participants, and outcomes of a multi-year (2010-2016), community-based randomized intervention trial in southern California', ""men's social support for their female wives/partners to receive a Pap test, and for women to receive a Pap test""]","[""pre-existing brochures on Pap testing (for women) or general men's health""]","[""women's Pap testing knowledge, fatalistic attitudes, or perceived social support"", 'Pap test behaviors']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0037438'}, {'cui': 'C0242665', 'cui_str': 'Wife (person)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1456606', 'cui_str': ""Men's Health""}]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0037438'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.02626,"IMPACT


Collaborative community-based interventions lead to increases in women's cancer prevention and early detection for Pacific Islander and other collectivistic communities.","[{'ForeName': 'Sora Park', 'Initials': 'SP', 'LastName': 'Tanjasiri', 'Affiliation': 'Department of Epidemiology, University of California, Irvine. tanjasir@uci.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mouttapa', 'Affiliation': 'Department of Public Health, California State University, Fullerton.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Sablan-Santos', 'Affiliation': 'Guam Communications Network, Inc., Long Beach, California.'}, {'ForeName': 'Jie W', 'Initials': 'JW', 'LastName': 'Weiss', 'Affiliation': 'Department of Public Health, California State University, Fullerton.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Chavarria', 'Affiliation': 'Guam Communications Network, Inc., Long Beach, California.'}, {'ForeName': 'Jasmine DeGuzman', 'Initials': 'JD', 'LastName': 'Lacsamana', 'Affiliation': 'Archstone Foundation, Long Beach, California.'}, {'ForeName': 'Vanessa Tuiòne', 'Initials': 'VT', 'LastName': 'May', 'Affiliation': 'Tongan Community Service Center/Special Service for Groups, Inc., Los Angeles, California.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Quitugua', 'Affiliation': 'Guam Communications Network, Inc., Long Beach, California.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Tupua', 'Affiliation': 'Samoan National Nurses Association, Long Beach, California.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Schmidt-Vaivao', 'Affiliation': 'Samoan National Nurses Association, Long Beach, California.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-18-1306']
155,32320729,Randomized in situ trial on the efficacy of Carbopol in enhancing fluoride / stannous anti-erosive properties.,"OBJECTIVE


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


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


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


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


Under highly erosive and abrasive conditions, rinsing with solutions containing sodium fluoride plus stannous chloride, associated or not with the Carbopol polymer, is an effective approach to control enamel erosive wear.",2020,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"['Cylindrical bovine enamel specimens', 'enamel erosive wear']","['sodium fluoride plus stannous chloride', 'FS (500\u2009ppm F- +800\u2009ppm', 'sodium fluoride with stannous chloride (FS) solution', 'Carbopol', 'bioadhesive polymer (Carbopol 980', 'palatal appliance containing 4 specimens: two were submitted to an erosion model (2\u2009h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5\u2009min, 4x/day; 1\u2009h intervals of saliva exposure']",['enamel loss'],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0108434', 'cui_str': 'Carbopol'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1542809', 'cui_str': 'Carbopol 980'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0322465,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"[{'ForeName': 'Daniele Mara da Silva', 'Initials': 'DMDS', 'LastName': 'Ávila', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: daniele-mara@uol.com.br.'}, {'ForeName': 'Rayssa Ferreira', 'Initials': 'RF', 'LastName': 'Zanatta', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil; Department of Restorative Dentistry, Dental School, University of Taubaté, Taubaté, Brazil. Electronic address: zanatta.rayssa@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, São Paulo University-USP, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Idalina Vieira', 'Initials': 'IV', 'LastName': 'Aoki', 'Affiliation': 'Department of Chemical Engineering, Polytechnic School, São Paulo University-USP, São Paulo, Brazil. Electronic address: idavaoki@usp.br.'}, {'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103347']
156,32093701,Effectiveness of PUSH notifications from a mobile app for improving the body composition of overweight or obese women: a protocol of a three-armed randomized controlled trial.,"BACKGROUND


The penetration level of mobile technology has grown exponentially and is part of our lifestyle, at all levels. The use of the smartphone has opened up a new horizon of possibilities in the treatment of health, not in vain, around 40% of existing applications are linked to the mHealth segment. Taking advantage of this circumstance to study new approaches in the treatment of obesity and prescription of physical activity is growing interest in the field of health. The primary outcome (obese adult women) will be assessed according to age, fitness status, weight, and body composition status. Data will be collected at enrollment and weekly during 6 months of intervention on dietary practices, physical activity, anthropometry, and body composition. Analysis of effect will be performed comparing the outcomes between intervention and control arms. The message delivery is in progress.
METHODS


A 3-arm clinical trial was established. A series of quantitative and qualitative measures were used to evaluate the effects of self-weighing and the establishment of objectives to be reached concerning the prescription of physical activity. At the end of this pilot study, a set of appropriate measures and procedures were identified and agreed upon to determine the effectiveness of messaging in the form of PUSH technology. The results were recorded and analyzed to begin a randomized controlled trial to evaluate the effectiveness of the proposed methodology.
CONCLUSIONS


The study is anticipated to establish feasibility of using PUSH notifications to evaluate whether or not an intervention of 6 months, directed by a team formed by Dietician-Nutritionist and nursing professionals, by means of an application for Smartphone and a personal consultation, improves the body composition of adult women with a fat percentage equal to or higher than 30% at the beginning of the study.
TRIAL REGISTRATION


Clinical Trials ID: NCT03911583. First Submitted: April 9, 2019. Ethical oversight is provided by the Bioethical Committee of Córdoba University and registered in the platform clinicaltrials.gov. The results will be published in peer-reviewed journals and analysis data will be made public.",2020,"The use of the smartphone has opened up a new horizon of possibilities in the treatment of health, not in vain, around 40% of existing applications are linked to the mHealth segment.","['overweight or obese women', 'adult women with a fat percentage equal to or higher than 30% at the beginning of the study']",[],"['dietary practices, physical activity, anthropometry, and body composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.0825315,"The use of the smartphone has opened up a new horizon of possibilities in the treatment of health, not in vain, around 40% of existing applications are linked to the mHealth segment.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hernández-Reyes', 'Affiliation': 'Department of Bromatology and Food Technology, University of Córdoba, Campus Rabanales, ed. Darwin - annex. Office of Dr. Rafael Moreno, 14071, Córdoba, Spain. z52heloa@uco.es.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Molina-Recio', 'Affiliation': 'Nursing department, University of Medicine and Nursing of Córdoba, Córdoba, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Molina-Luque', 'Affiliation': 'Nursing department, University of Medicine and Nursing of Córdoba, Córdoba, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Romero-Saldaña', 'Affiliation': 'Department of Occupational Health and Safety, Córdoba, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cámara-Martos', 'Affiliation': 'Department of Bromatology and Food Technology, University of Córdoba, Campus Rabanales, ed. Darwin - annex. Office of Dr. Rafael Moreno, 14071, Córdoba, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Moreno-Rojas', 'Affiliation': 'Department of Bromatology and Food Technology, University of Córdoba, Campus Rabanales, ed. Darwin - annex. Office of Dr. Rafael Moreno, 14071, Córdoba, Spain.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-1058-7']
157,32319039,Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review.,"Migraine is a debilitating neurologic disease. People who experience migraine can have substantial disability, impaired functioning and a decreased quality of life (QoL). Expert recommendations suggest that people with frequent migraine attacks or severe impairment related to attacks may benefit from preventive treatment. Despite these recommendations and the existence of evidence-based guidelines for the use of preventive medication, many people who are candidates for preventive therapies do not receive them. Thus, there is still a substantial unmet need for preventive migraine treatment. Calcitonin gene-related peptide (CGRP) has a demonstrated role in the pathophysiology of migraine. Galcanezumab-gnlm (galcanezumab) is a humanized monoclonal antibody that binds to the CGRP ligand and prevents binding to its receptor. It is administered as a once-monthly subcutaneous injection. The aim of this review is to present a comprehensive overview of the existing short- and long-term efficacy and safety data for galcanezumab in patients with migraine. Data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2 and REGAIN studies show that galcanezumab treatment for 3 or 6 months results in overall reduction in mean monthly migraine headache days in patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine. Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning. A 12-month open-label study demonstrated the continued efficacy of galcanezumab for up to 12 months. In all studies galcanezumab was well tolerated. In conclusion, data from pivotal studies show that galcanezumab may fulfill an unmet need in the treatment of patients with migraine who require preventive therapy.",2020,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","['patients with migraine', 'patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine', 'patients with migraine who require preventive therapy', 'Migraine']","['Calcitonin gene-related peptide (CGRP', 'Migraine', 'Galcanezumab-gnlm (galcanezumab', 'galcanezumab', 'placebo', 'galcanezumab versus placebo', 'Galcanezumab']","['Efficacy and Safety', 'quality of life (QoL', 'level of disability', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C4731561', 'cui_str': 'galcanezumab-gnlm'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0581009,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Martin', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Karen Hamrick', 'Initials': 'KH', 'LastName': 'Samaan', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA. karen.samaan@lilly.com.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pallay', 'Affiliation': 'Department of Family Medicine, Mercer University School of Medicine, Savannah, GA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01319-9']
158,32213470,Brief Web-Based Intervention for Depression: Randomized Controlled Trial on Behavioral Activation.,"BACKGROUND


Web-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).
OBJECTIVE


The aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group.
METHODS


We assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t 0 ) and 2 weeks (t 1 ) and 4 weeks (t 2 ) later. After the t 0  assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life.
RESULTS


While groups did not differ regarding the change in depression from t 0  to t 1  (η p 2 =.007, P=.746) or t 0  to t 2  (η p 2 =.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t 0  to t 2  in comparison to CAU (η p 2 =.053, P=.04) and a larger increase in activity from t 0  to t 1  than the pooled control groups (η p 2 =.060, P=.02). A change in depression from t 0  to t 2  was mediated by a change in activity from t 0  to t 1 . At t 1 , 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention.
CONCLUSIONS


Although we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval.
TRIAL REGISTRATION


DKRS (#DRKS00011562).",2020,"While groups did not differ regarding the change in depression from t 0  to t 1  (η p 2 =.007, P=.746) or t 0  to t 2  (η p 2 =.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t 0  to t 2  in comparison to CAU (η p 2 =.053, P=.04) and a larger increase in activity from t 0  to t 1  than the pooled control groups (η p 2 =.060, P=.02).","['Depression', '104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t 0 ) and 2 weeks (t 1 ) and 4 weeks (t 2 ) later']","['active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU', 'Brief Web-Based Intervention']","['changes in activity, dysfunctional attitudes, and quality of life', 'activity', 'depressive symptoms, as measured using the Patient Health Questionnaire-9', 'depression', 'dysfunctional attitudes', 'change in depression']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",104.0,0.154823,"While groups did not differ regarding the change in depression from t 0  to t 1  (η p 2 =.007, P=.746) or t 0  to t 2  (η p 2 =.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t 0  to t 2  in comparison to CAU (η p 2 =.053, P=.04) and a larger increase in activity from t 0  to t 1  than the pooled control groups (η p 2 =.060, P=.02).","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sönke', 'Initials': 'S', 'LastName': 'Arlt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Westermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of medical Internet research,['10.2196/15312']
159,31403552,Cold Pulsatile Machine Perfusion Versus Static Cold Storage for Kidneys Donated After Circulatory Death: A Multicenter Randomized Controlled Trial.,"BACKGROUND


The benefits of cold pulsatile machine perfusion (MP) for the storage and transportation of kidneys donated after circulatory death are disputed. We conducted a UK-based multicenter, randomized controlled trial to compare outcomes of kidneys stored with MP versus static cold storage (CS).
METHODS


Fifty-one pairs of kidneys donated after circulatory death were randomly allocated to receive static CS or cold pulsatile MP. The primary endpoint, delayed graft function, was analyzed by ""intention-to-treat"" evaluation.
RESULTS


There was no difference in the incidence of delayed graft function between CS and MP (32/51 (62.8%) and 30/51 (58.8%) P = 0.69, respectively), although the trial stopped early due to difficulty with recruitment. There was no difference in the incidence of acute rejection, or in graft or patient survival between the CS and MP groups. Median estimated glomerular filtration rate at 3 months following transplantation was significantly lower in the CS group compared with MP (CS 34 mL/min IQR 26-44 vs MP 45 mL/min IQR 36-60, P = 0.006), although there was no significant difference in estimated glomerular filtration rate between CS and MP at 12 months posttransplant.
CONCLUSIONS


This study is underpowered, which limits definitive conclusions about the use of MP, as an alternative to static CS. It did not demonstrate that the use of MP reduces the incidence of delayed graft function in donation after circulatory death kidney transplantation.",2020,"There was no difference in the incidence of acute rejection, or in graft or patient survival between the CS and MP groups.","['donation after circulatory death kidney transplantation', '51 pairs of DCD donor kidneys', 'kidneys donated after circulatory death']","['Cold pulsatile machine perfusion versus static cold storage', 'kidneys stored with machine perfusion (MP) versus static cold storage (CS', 'cold pulsatile machine perfusion', 'static cold storage or cold pulsatile machine perfusion', 'machine perfusion']","[""intention-to-treat' evaluation"", 'incidence of DGF', 'delayed graft function (DGF', 'incidence of acute rejection, or in graft or patient survival', 'Median eGFR', 'eGFR']","[{'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0608070', 'cui_str': 'dicarboxydine'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile (qualifier value)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",51.0,0.35985,"There was no difference in the incidence of acute rejection, or in graft or patient survival between the CS and MP groups.","[{'ForeName': 'Dominic M', 'Initials': 'DM', 'LastName': 'Summers', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Niaz', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Transplantation, Leeds University Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Lucy V', 'Initials': 'LV', 'LastName': 'Randle', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Johnson', 'Affiliation': 'Statistics and Clinical Studies Department, Organ Donation and Transplantation NHSBT, Bristol, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Collett', 'Affiliation': 'Statistics and Clinical Studies Department, Organ Donation and Transplantation NHSBT, Bristol, United Kingdom.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Attia', 'Affiliation': 'Department of Transplantation, Leeds University Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clancy', 'Affiliation': 'Department of Transplantation, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Tavakoli', 'Affiliation': 'Department of Transplantation, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Department of Transplantation, Edinburgh University, Edinburgh, United Kingdom.'}, {'ForeName': 'Neville V', 'Initials': 'NV', 'LastName': 'Jamieson', 'Affiliation': 'Department of Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Bradley', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'J E Watson', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, United Kingdom.'}]",Transplantation,['10.1097/TP.0000000000002907']
160,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


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


Prospective crossover physiologic study.
SETTING


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


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


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


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


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
161,32317617,Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study: Erratum.,,2020,,['De Novo Kidney Transplants'],['Everolimus'],[],"[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}]",[],,0.0376922,,[],Transplantation,['10.1097/TP.0000000000003234']
162,31799616,Multielectrode Transcranial Electrical Stimulation of the Left and Right Prefrontal Cortices Differentially Impacts Verbal Working Memory Neural Circuitry.,"Recent studies have examined the effects of conventional transcranial direct current stimulation (tDCS) on working memory (WM) performance, but this method has relatively low spatial precision and generally involves a reference electrode that complicates interpretation. Herein, we report a repeated-measures crossover study of 25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits. Shortly after each stimulation session, participants performed a verbal WM (VWM) task during magnetoencephalography, and the resulting data were examined in the time-frequency domain and imaged using a beamformer. We found that after left DLPFC stimulation, participants exhibited stronger responses across a network of left-lateralized cortical areas, including the supramarginal gyrus, prefrontal cortex, inferior frontal gyrus, and cuneus, as well as the right hemispheric homologues of these regions. Importantly, these effects were specific to the alpha-band, which has been previously implicated in VWM processing. Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus. These findings suggest that multielectrode tDCS targeting the left DLPFC affects the neural dynamics underlying offline VWM processing, including utilization of a more extensive bilateral cortical network.",2020,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","['25 healthy adults who underwent multielectrode tDCS of the left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or sham in 3 separate visits']",['conventional transcranial direct current stimulation (tDCS'],"['working memory (WM) performance', 'reaction time and response amplitude']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",25.0,0.0283869,"Although stimulation condition did not significantly affect performance, stepwise regression revealed a relationship between reaction time and response amplitude in the left precuneus and supramarginal gyrus.","[{'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Koshy', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Alex I', 'Initials': 'AI', 'LastName': 'Wiesman', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Spooner', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Embury', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rezich', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Heinrichs-Graham', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}, {'ForeName': 'Tony W', 'Initials': 'TW', 'LastName': 'Wilson', 'Affiliation': 'Center for Magnetoencephalography, University of Nebraska Medical Center, Omaha, NE 68198, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhz246']
163,32207689,The Association of Therapeutic Alliance With Long-Term Outcome in a Guided Internet Intervention for Depression: Secondary Analysis From a Randomized Control Trial.,"BACKGROUND


Therapeutic alliance has been well established as a robust predictor of face-to-face psychotherapy outcomes. Although initial evidence positioned alliance as a relevant predictor of internet intervention success, some conceptual and methodological concerns were raised regarding the methods and instruments used to measure the alliance in internet interventions and its association with outcomes.
OBJECTIVE


The aim of this study was to explore the alliance-outcome association in a guided internet intervention using a measure of alliance especially developed for and adapted to guided internet interventions, showing evidence of good psychometric properties.
METHODS


A sample of 223 adult participants with moderate depression received an internet intervention (ie, Deprexis) and email support. They completed the Working Alliance Inventory for Guided Internet Intervention (WAI-I) and a measure of treatment satisfaction at treatment termination and measures of depression severity and well-being at termination and 3- and 9-month follow-ups. For data analysis, we used two-level hierarchical linear modeling that included two subscales of the WAI-I (ie, tasks and goals agreement with the program and bond with the supporting therapist) as predictors of the estimated values of the outcome variables at the end of follow-up and their rate of change during the follow-up period. The same models were also used controlling for the effect of patient satisfaction with treatment.
RESULTS


We found significant effects of the tasks and goals subscale of the WAI-I on the estimated values of residual depressive symptoms (γ 02 =-1.74, standard error [SE]=0.40, 95% CI -2.52 to -0.96, t 206 =-4.37, P<.001) and patient well-being (γ 02 =3.10, SE=1.14, 95% CI 0.87-5.33, t 198 =2.72, P=.007) at the end of follow-up. A greater score in this subscale was related to lower levels of residual depressive symptoms and a higher level of well-being. However, there were no significant effects of the tasks and goals subscale on the rate of change in these variables during follow-up (depressive symptoms, P=.48; patient well-being, P=.26). The effects of the bond subscale were also nonsignificant when predicting the estimated values of depressive symptoms and well-being at the end of follow-up and the rate of change during that period (depressive symptoms, P=.08; patient well-being, P=.68).
CONCLUSIONS


The results of this study point out the importance of attuning internet interventions to patients' expectations and preferences in order to enhance their agreement with the tasks and goals of the treatment. Thus, the results support the notion that responsiveness to a patient's individual needs is crucial also in internet interventions. Nevertheless, these findings need to be replicated to establish if they can be generalized to different diagnostic groups, internet interventions, and supporting formats.",2020,A greater score in this subscale was related to lower levels of residual depressive symptoms and a higher level of well-being.,"['Depression', '223 adult participants with moderate depression received an']","['guided internet intervention', 'internet intervention (ie, Deprexis) and email support', 'Guided Internet Intervention']","['tasks and goals subscale of the WAI', 'residual depressive symptoms']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",223.0,0.0785418,A greater score in this subscale was related to lower levels of residual depressive symptoms and a higher level of well-being.,"[{'ForeName': 'Juan Martín', 'Initials': 'JM', 'LastName': 'Gómez Penedo', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Anna Margarete', 'Initials': 'AM', 'LastName': 'Babl', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Department of Psychosomatic Medicine, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Hohagen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychology, City, University of London, London, United Kingdom.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}]",Journal of medical Internet research,['10.2196/15824']
164,32127214,"Corrigendum re ""Extracorporeal Shock Wave Therapy for the Treatment of Chronic Pelvic Pain Syndrome in Males: A Randomised, Double-Blind, Placebo-Controlled Study"" [Eur Urol 2009;56:418-24].",,2020,,['Chronic Pelvic Pain Syndrome in Males'],"['Corrigendum re ""Extracorporeal Shock Wave Therapy', 'Placebo']",[],"[{'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.319935,,"[{'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Urology, Elisabethinen Hospital, University-affiliated Hospital, Linz, Austria. Electronic address: reinhold.zimmermann@gmx.de.'}, {'ForeName': 'Alin', 'Initials': 'A', 'LastName': 'Cumpanas', 'Affiliation': 'Department of Urology, Victor Babeș University of Medicine and Pharmacy, Timisoara, Romania.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Miclea', 'Affiliation': 'Department of Urology, Victor Babeș University of Medicine and Pharmacy, Timisoara, Romania.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Janetschek', 'Affiliation': 'Department of Urology, Elisabethinen Hospital, University-affiliated Hospital, Linz, Austria.'}]",European urology,['10.1016/j.eururo.2020.02.011']
165,32315648,Validity and Responsiveness of Floor Sitting-Rising Test in Post-Total Knee Arthroplasty: A Cohort Study.,"OBJECTIVES


To assess the construct validity and responsiveness of the floor sitting-rising test (SRT) in individuals with total knee arthroplasty (TKA).
DESIGN


Cohort study with 6-month follow-up. Secondary analysis using data from a randomized controlled trial.
SETTING


An outpatient rehabilitation research center.
PARTICIPANTS


Participants (N=240) enrolled in the parent study who had unilateral primary TKA.
INTERVENTION


Participants in the parent study underwent 12 weeks of exercise programs.
MAIN OUTCOME MEASURES


Validity analysis correlated baseline data of participants who completed the SRT and measures of knee motion, muscle strength, performance-based tests, and patient-reported outcomes of physical and psychosocial function. Responsiveness analysis used the 3- and 6-month follow-up data. Effect sizes were calculated using changes from baseline. Areas under the receiving operating characteristics curve were calculated using a global rating of change as the external anchor.
RESULTS


Of the 240 participants (148 women; age, 70±7y), 180 (75%) were able to perform the SRT at baseline. Performers scored significantly better in all physical function tests (P<.0001) than nonperformers. SRT scores generally converged with measures of knee impairment and performance-based tests (associations ranged from small [r=0.15; P=.0516] to moderate [r=0.52; P<.0001]). SRT scores associated with self-efficacy for function (r=0.34; P<.0001) and fear of falls (r=-0.25; P=.001). At 3 (n=174) and 6 months (n=160), SRT effect sizes were 0.38 (95% confidence interval, 0.25-0.52) and 0.42 (95% confidence interval, 0.25-0.60), and areas under the curve were 0.59 (95% confidence interval, 0.49-0.69) and 0.62 (95% confidence interval, 0.52-0.73), respectively.
CONCLUSIONS


The results add evidence to the validity of the SRT in patients after TKA. The strength of the associations suggests that the SRT measures a physical function construct not captured by the other tests. The magnitude of indices of responsiveness for the SRT were similar to other performance-based tests, indicating comparable responsiveness to more widespread tests of functional performance.",2020,SRT scores associated with self-efficacy for function (r=0.34; p=<0.0001) and fear of falls (r=-0.25; p=0.001).,"['All 240 participants enrolled in the parent study who had unilateral primary TKA', '240 participants (148 female, age 70±7SD years), 180 (75', 'Post-Total Knee Arthroplasty', 'Outpatient rehabilitation research center', 'individuals with total knee arthroplasty (TKA']","['exercise programs', 'floor sitting-rising test (SRT']","['fear of falls', 'SRT effect sizes', 'SRT scores', 'Validity and responsiveness of floor Sitting-Rising Test', 'knee motion, muscle strength, performance-based tests, and patient-reported outcomes (PROs) of physical and psychosocial function']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1514830', 'cui_str': 'Rehabilitation Research'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",240.0,0.113594,SRT scores associated with self-efficacy for function (r=0.34; p=<0.0001) and fear of falls (r=-0.25; p=0.001).,"[{'ForeName': 'Jehan A', 'Initials': 'JA', 'LastName': 'Alomar', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Maria Beatriz C', 'Initials': 'MBC', 'LastName': 'Catelani', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clair N', 'Initials': 'CN', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Charity G', 'Initials': 'CG', 'LastName': 'Patterson', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Tamara M', 'Initials': 'TM', 'LastName': 'Artman', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Piva', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh, Pittsburgh, PA. Electronic address: spiva@pitt.edu.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.012']
166,32315696,Testing the effects of transcranial direct current stimulation (tDCS) on the face inversion effect and the N170 event-related potentials (ERPs) component.,"The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces). We combined tDCS and EEG simultaneously to examine the effects of tDCS on the face inversion effect behaviourally and on the N170 ERPs component. The results from two experiments (overall N = 112) show that anodal tDCS delivered at Fp3 site for 10 min at 1.5 mA (double-blind and between-subjects) can reduce behaviourally the face inversion effect compared to sham (control) stimulation. The ERP results provide some evidence for tDCS being able to influence the face inversion effect on the N170. Specifically, we find a dissociation of the tDCS-induced effects where for the N170 latencies the tDCS reduces the usual face inversion effect (delayed N170 in response to inverted vs. upright faces) compared to sham. Contrarily, the same tDCS procedure on the same participants increased the inversion effect seen in the N170 amplitudes by making the negative deflection for the inverted faces that much greater than that for upright faces. We interpret our results in the context of the literature on the face inversion effect and the N170 peak component. In doing so, we extend our results to previous studies investigating the effects of tDCS on perceptual learning and face recognition.",2020,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,[],"['tDCS', 'transcranial direct current stimulation (tDCS', 'anodal tDCS']",['perceptual learning and face recognition'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0243991,The following study investigates the effects of tDCS on face recognition skills indexed by the face inversion effect (better recognition performance for upright vs. inverted faces).,"[{'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Civile', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: c.civile@exeter.ac.uk.'}, {'ForeName': 'Emika', 'Initials': 'E', 'LastName': 'Waguri', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Quaglia', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wooster', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Rossy', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'Aureliu', 'Initials': 'A', 'LastName': 'Lavric', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK.'}, {'ForeName': 'I P L', 'Initials': 'IPL', 'LastName': 'McLaren', 'Affiliation': 'School of Psychology, College of Life and Environmental Sciences, University of Exeter, UK. Electronic address: i.p.l.mclaren@exeter.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107470']
167,32320533,First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression.,"OBJECTIVE


Obesity and depression are prevalent and often co-occurring conditions in the United States. The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized trial demonstrated the effectiveness of an integrated intervention for adults with both conditions. Characterizing the intervention's economic effects is important for broader dissemination and implementation.
METHODS


This study evaluated the cost (2018 US dollars) and health-related quality of life (HRQoL) impacts during RAINBOW's first year, comparing intervention (n = 204) and usual-care groups (n = 205). Outcomes included intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes from baseline using Euroqol-5D US utility weights.
RESULTS


RAINBOW's 1-year delivery cost per person was $2,251. Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027). Annual antidepressant medication spending had a larger, nonsignificant increase ($89 [95% CI: -$20 to $197]; P = 0.109). Annual spending on medical care services had a smaller, nonsignificant decrease (-$54 [95% CI: -$832 to $941]; P = 0.905). HRQoL had a nonsignificant increase (0.011 [95% CI: -0.025 to 0.047]; P = 0.546).
CONCLUSIONS


The RAINBOW intervention's economic value will depend on how its 1-year improvements in obesity and depression translate into long-term reduced morbidity, delayed mortality, or averted costs.",2020,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).",['adults with both conditions'],['integrated intervention'],"['Annual spending on medical care services', 'intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0723905,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Prince', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22805']
168,32320006,Nicotinamide riboside supplementation alters body composition and skeletal muscle acetylcarnitine concentrations in healthy obese humans.,"BACKGROUND


Nicotinamide riboside (NR) is an NAD+ precursor that boosts cellular NAD+ concentrations. Preclinical studies have shown profound metabolic health effects after NR supplementation.
OBJECTIVES


We aimed to investigate the effects of 6 wk NR supplementation on insulin sensitivity, mitochondrial function, and other metabolic health parameters in overweight and obese volunteers.
METHODS


A randomized, double-blinded, placebo-controlled, crossover intervention study was conducted in 13 healthy overweight or obese men and women. Participants received 6 wk NR (1000 mg/d) and placebo supplementation, followed by broad metabolic phenotyping, including hyperinsulinemic-euglycemic clamps, magnetic resonance spectroscopy, muscle biopsies, and assessment of ex vivo mitochondrial function and in vivo energy metabolism.
RESULTS


Markers of increased NAD+ synthesis-nicotinic acid adenine dinucleotide and methyl nicotinamide-were elevated in skeletal muscle after NR compared with placebo. NR increased body fat-free mass (62.65% ± 2.49% compared with 61.32% ± 2.58% in NR and placebo, respectively; change: 1.34% ± 0.50%, P = 0.02) and increased sleeping metabolic rate. Interestingly, acetylcarnitine concentrations in skeletal muscle were increased upon NR (4558 ± 749 compared with 3025 ± 316 pmol/mg dry weight in NR and placebo, respectively; change: 1533 ± 683 pmol/mg dry weight, P = 0.04) and the capacity to form acetylcarnitine upon exercise was higher in NR than in placebo (2.99 ± 0.30 compared with 2.40 ± 0.33 mmol/kg wet weight; change: 0.53 ± 0.21 mmol/kg wet weight, P = 0.01). However, no effects of NR were found on insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism.
CONCLUSIONS


NR supplementation of 1000 mg/d for 6 wk in healthy overweight or obese men and women increased skeletal muscle NAD+ metabolites, affected skeletal muscle acetylcarnitine metabolism, and induced minor changes in body composition and sleeping metabolic rate. However, no other metabolic health effects were observed.This trial was registered at clinicaltrials.gov as NCT02835664.",2020,"However, no effects of NR were found on insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism.
","['overweight and obese volunteers', 'healthy obese humans', '13 healthy overweight or obese men and women', 'healthy overweight or obese men']","['placebo supplementation, followed by broad metabolic phenotyping, including hyperinsulinemic-euglycemic clamps, magnetic resonance spectroscopy, muscle biopsies, and assessment of ex vivo mitochondrial function and in vivo energy metabolism', 'placebo', '6 wk NR supplementation', 'Nicotinamide riboside supplementation']","['NAD+ synthesis-nicotinic acid adenine dinucleotide and methyl nicotinamide', 'insulin sensitivity, mitochondrial function, and other metabolic health parameters', 'body composition and sleeping metabolic rate', 'insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism', 'body fat-free mass', 'sleeping metabolic rate', 'metabolic health effects', 'capacity to form acetylcarnitine upon exercise', 'skeletal muscle NAD+ metabolites', 'acetylcarnitine concentrations in skeletal muscle']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0068711', 'cui_str': 'nicotinamide-beta-riboside'}]","[{'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0068723', 'cui_str': 'nicotinic acid adenine dinucleotide'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0232174', 'cui_str': 'Cardiac ejection fraction'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",13.0,0.485712,"However, no effects of NR were found on insulin sensitivity, mitochondrial function, hepatic and intramyocellular lipid accumulation, cardiac energy status, cardiac ejection fraction, ambulatory blood pressure, plasma markers of inflammation, or energy metabolism.
","[{'ForeName': 'Carlijn M E', 'Initials': 'CME', 'LastName': 'Remie', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Kay H M', 'Initials': 'KHM', 'LastName': 'Roumans', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Michiel P B', 'Initials': 'MPB', 'LastName': 'Moonen', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Niels J', 'Initials': 'NJ', 'LastName': 'Connell', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Mevenkamp', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Lindeboom', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Vera H W', 'Initials': 'VHW', 'LastName': 'de Wit', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'van de Weijer', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Suzanne A B M', 'Initials': 'SABM', 'LastName': 'Aarts', 'Affiliation': 'Department of Medical Biochemistry, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lutgens', 'Affiliation': 'Department of Medical Biochemistry, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bauke V', 'Initials': 'BV', 'LastName': 'Schomakers', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Hyung L', 'Initials': 'HL', 'LastName': 'Elfrink', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Zapata-Pérez', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Riekelt H', 'Initials': 'RH', 'LastName': 'Houtkooper', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Auwerx', 'Affiliation': 'Laboratory of Integrative and Systems Physiology, École Polytechnique Fédérale de Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa072']
169,30993861,"Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study (PRIME-V study).","A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI) ≥ 22 kg/m 2  . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (-12.06% vs. -3.65%, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors.",2019,"Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (-12.06% vs. -3.65%, P = 0.040).","['Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI)\u2009≥\u200922\u2009kg/m 2  ', 'Japanese patients with type 2 diabetes treated with']","['Metformin', 'ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin', 'sitagliptin', 'metformin', 'ipragliflozin', 'ipragliflozin versus metformin', 'ipragliflozin or metformin', 'Ipragliflozin', 'ipragliflozin 50\u2009mg or metformin 1000-1500\u2009mg daily']","['HbA1c and LDL-cholesterol levels and increased HOMA-beta', 'glucose metabolism and lipid metabolism', 'Mean percentage reduction in visceral fat area', 'severe adverse events', 'visceral fat reduction and metabolic dysfunction', 'change in visceral fat area', 'reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0017742', 'cui_str': 'Glucose Transport Proteins, Facilitative'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0853084', 'cui_str': 'Increased HDL'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}]",,0.0313399,"Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (-12.06% vs. -3.65%, P = 0.040).","[{'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Koshizaka', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Maezawa', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Daigaku', 'Initials': 'D', 'LastName': 'Uchida', 'Affiliation': 'Department of Internal Medicine, Hotaruno Central Naika, Chiba, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Internal Medicine, Odayama Clinic, Chiba, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Yamaga', 'Affiliation': 'Department of Diabetes and Metabolism, Japanese Red Cross Narita Hospital, Chiba, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Yokoh', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Akina', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Onishi', 'Affiliation': 'Department of Diabetes and Metabolism, Asahi General Hospital, Chiba, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ogino', 'Affiliation': ""Department of Diabetes, Endocrine and Metabolic Diseases, Tokyo Women's Medical University Yachiyo Medical Center, Chiba, Japan.""}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': ""Department of Diabetes, Endocrine and Metabolic Diseases, Tokyo Women's Medical University Yachiyo Medical Center, Chiba, Japan.""}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Department of Internal Medicine, Yukarigaoka Tokuyama Medical Clinic, Chiba, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Shimada', 'Affiliation': 'Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Chiba, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Ohara', 'Affiliation': 'Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Chiba, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Shoji', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Ide', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hattori', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Kitamoto', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Horikoshi', 'Affiliation': 'Diagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Shimofusa', 'Affiliation': 'Department of Radiology, Sannou Hospital, Chiba, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nagashima', 'Affiliation': 'Department of Global Clinical Research, Chiba University, Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Global Clinical Research, Chiba University, Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, School of Medicine, International University of Health and Welfare, Chiba, Japan.'}, {'ForeName': 'Laura Kristin', 'Initials': 'LK', 'LastName': 'Newby', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13750']
170,32372570,Effect of a responsive parenting intervention on child emotional overeating is mediated by reduced maternal use of food to soothe: The INSIGHT RCT.,"BACKGROUND


Child emotional overeating is a risk factor for obesity that is learned in the home environment. Parents' use of food to soothe child distress may contribute to the development of children's emotional overeating.
OBJECTIVES


To examine the effect of a responsive parenting (RP) intervention on mother-reported child emotional overeating, and explore whether effects are mediated by mother-reported use of food to soothe child distress.
METHODS


The sample included primiparous mother-infant dyads randomized to a RP intervention (n = 105) or home safety control group (n = 102). Nurses delivered RP guidance in four behavioral domains: sleeping, fussy, alert/calm, and drowsy. Mothers reported their use of food to soothe at age 18 months and child emotional overeating at age 30 months. Mediation was analyzed using the SAS PROCESS macro.
RESULTS


RP intervention mothers reported less frequent use of food to soothe and perceived their child's emotional overeating as lower compared to the control group. Food to soothe mediated the RP intervention effect on child emotional overeating (mediation model: R 2  = 0.13, P < .0001).
CONCLUSIONS


Children's emotional overeating may be modified through an early life RP intervention. Teaching parents alternative techniques to soothe child distress rather than feeding may curb emotional overeating development to reduce future obesity risk.",2020,"Nurses delivered RP guidance in four behavioral domains: sleeping, fussy, alert/calm, and drowsy.",[],"['RP intervention (n = 105) or home safety control group', 'responsive parenting intervention', 'responsive parenting (RP) intervention']","['child emotional overeating', ""frequent use of food to soothe and perceived their child's emotional overeating""]",[],"[{'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0187667,"Nurses delivered RP guidance in four behavioral domains: sleeping, fussy, alert/calm, and drowsy.","[{'ForeName': 'Holly A', 'Initials': 'HA', 'LastName': 'Harris', 'Affiliation': 'Center for Childhood Obesity Research, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Anzman-Frasca', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Michele E', 'Initials': 'ME', 'LastName': 'Marini', 'Affiliation': 'Center for Childhood Obesity Research, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Pediatrics and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Leann L', 'Initials': 'LL', 'LastName': 'Birch', 'Affiliation': 'Department of Foods and Nutrition, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, The Pennsylvania State University, University Park, Pennsylvania, USA.'}]",Pediatric obesity,['10.1111/ijpo.12645']
171,32107938,The Legacy Effect in Treating Hypercholesterolemia.,"BACKGROUND


The duration of randomized controlled clinical trials usually is approximately 3 to 5 years although hypercholesterolemia and other risk factors for atherosclerotic cardiovascular disease (ASCVD) are lifelong conditions.
OBJECTIVES


The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit. We summarize the evidence for the existence of the legacy effect as it pertains to hypercholesterolemia, describe underlying mechanisms, and discuss its relevance to clinical practice.
METHODS


We examined all published (n = 13) randomized clinical trials of lipid-lowering agents compared to placebo or usual care with follow-up after the randomized phase for the presence or absence of a legacy effect.
RESULTS


A legacy effect was demonstrated in all studies. The current US and European guidelines recommend treatment with high-intensity statins for patients with manifest ASCVD and that individualized approach be used for primary prevention.
CONCLUSION


The legacy effect results in significant long-term clinical benefits by preventing fatal and nonfatal events. This implies that early therapy would result in lower event rates. Long-term follow-up should be a part of clinical trial design in order to evaluate the presence or absence of a legacy effect.",2020,"The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit.","['patients with manifest ASCVD', 'We examined all published (n = 13) randomized clinical trials of']",['lipid-lowering agents compared to placebo'],['fatal and nonfatal events'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0086440', 'cui_str': 'Antilipemic Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",13.0,0.120009,"The legacy effect, defined as the persistence of benefit of pharmacologic interventions in clinical trials after the end of the randomized phase when all participants receive active therapy, is used to examine the long-term benefit.","[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Mrinali', 'Initials': 'M', 'LastName': 'Shetty', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Yuvraj Singh', 'Initials': 'YS', 'LastName': 'Chowdhury', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, Cardiovascular Institute, New Brunswick, NJ, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420907256']
172,29332989,Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial.,"This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans ( N  = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual art therapy. PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups. Art therapy in conjunction with CPT was found to improve trauma processing and veterans considered it to be an important part of their treatment as it provided healthy distancing, enhanced trauma recall, and increased access to emotions.",2016,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"['Veterans ( N  = 11', 'Combat-Related PTSD']","['Cognitive Processing Therapy (CPT', 'individual CPT, or individual CPT in conjunction with individual art therapy', 'Art Therapy and Cognitive Processing Therapy']",['PTSD Checklist-Military Version and Beck Depression Inventory-II scores'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}]",11.0,0.0332411,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Art therapist at the University Neuro-psychiatric Institute, University of Utah, Salt Lake City.'}, {'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Decker', 'Affiliation': 'Staff psychiatrist at the Hampton VA Medical Center, Hampton, VA, and faculty member in the Department of Psychiatry at Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kruk', 'Affiliation': 'Community faculty.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Deaver', 'Affiliation': 'Professor in the Graduate Art Therapy and Counseling Professions Program, Eastern Virginia Medical School.'}]",Art therapy : journal of the American Art Therapy Association,['10.1080/07421656.2016.1226643']
173,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND


Infant gut dysbiosis, often associated with low abundance of bifidobacteria, is linked to impaired immune development and inflammation-a risk factor for increased incidence of several childhood diseases. We investigated the impact of B. infantis EVC001 colonization on enteric inflammation in a subset of exclusively breastfed term infants from a larger clinical study.
METHODS


Stool samples (n = 120) were collected from infants randomly selected to receive either 1.8 × 10 10  CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal. The fecal microbiome was analyzed using 16S ribosomal RNA, proinflammatory cytokines using multiplexed immunoassay, and fecal calprotectin using ELISA at three time points: days 6 (Baseline), 40, and 60 postnatal.
RESULTS


Fecal calprotectin concentration negatively correlated with Bifidobacterium abundance (P < 0.0001; ρ = -0.72), and proinflammatory cytokines correlated with Clostridiaceae and Enterobacteriaceae, yet negatively correlated with Bifidobacteriaceae abundance. Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
CONCLUSION


Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2']
174,32306021,[Effect of concentrated growth factors combined with guided tissue regeneration in treatment of classII furcation involvements of mandibular molars].,"OBJECTIVE


Tissues loss due to periodontal disease is typically treated by a variety of regenerative treatment modalities, including bone grafts, guided tissue regeneration (GTR) and growth factors, to reform the supporting tissues of teeth. Concentrated growth factors (CGF) are produced by centrifuging blood samples at alternating and controlled speeds using a special centrifuge. The purpose of this study was to evaluate whether GTR could improve the effect of CGF combined with bone graft in the treatment of classII furcations of mandibular molars.
METHODS


In the present study, thirty-five classII furcation involvements were included and randomly divided into two groups. The experimental group (n=17) accepted GTR combined with CGF and bone graft therapy, and the controlled group (n=18) accepted CGF combined with bone graft therapy. The clinical examinations and cone beam computed tomography (CBCT) were performed at baseline and 1 year post-surgery. Comparisons of clinical and CBCT data before and after operation between the experimental group and the control group were made.
RESULTS


The clinical and CBCT data of both groups were not statistically different at baseline (P>0.05). At the end of 1 year post-surgery, the clinical parameters of both groups were significantly improved (P<0.001). The probing depths of the experimental group were (4.81±1.95) mm and (3.56±1.94) mm, respectively, significantly higher than the changes of the control group (P<0.001). The vertical and horizontal attachment gains of the experimental group were (4.11±1.98) mm and (3.84±1.68) mm, respectively, significantly higher than the changes of the control group (P<0.001). At the end of 1 year post-surgery, the experimental group showed significantly higher bone gain at vertical and horizontal directions compared with those of the control group: (3.84±1.68) and (3.88±2.12) mm, respectively (P<0.001).
CONCLUSION


Within the limitation of the present study, GTR showed positive role in the effect of CGF combined with bone graft in the treatment of classII furcation involvements of mandibular molars.",2020,"At the end of 1 year post-surgery, the experimental group showed significantly higher bone gain at vertical and horizontal directions compared with those of the control group: (3.84±1.68) and (3.88±2.12) mm, respectively (P<0.001).
","['classII furcation involvements of mandibular molars', 'thirty-five classII furcation involvements', 'classII furcations of mandibular molars']","['GTR combined with CGF and bone graft therapy', 'concentrated growth factors combined with guided tissue regeneration', 'CGF combined with bone graft therapy', 'Concentrated growth factors (CGF', 'GTR', 'cone beam computed tomography (CBCT', 'CGF combined with bone graft']","['bone gain at vertical and horizontal directions', 'vertical and horizontal attachment gains']","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0085147', 'cui_str': 'Regeneration, Guided Tissue'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",35.0,0.0415352,"At the end of 1 year post-surgery, the experimental group showed significantly higher bone gain at vertical and horizontal directions compared with those of the control group: (3.84±1.68) and (3.88±2.12) mm, respectively (P<0.001).
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Duan', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100034, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
175,31390289,Improving Reading Comprehension in the Primary Grades: Mediated Effects of a Language-Focused Classroom Intervention.,"Purpose This article includes results from a multistate randomized controlled trial designed to investigate the impacts of a language-focused classroom intervention on primary grade students' proximal language skills and distal reading comprehension skills. Method The sample included 938 children from 160 classrooms in 4 geographic regions in the United States; each classroom was randomly assigned to 1 of 2 experimental conditions (2 variations of a language-focused intervention) or business-as-usual control. For this study, the 2 experimental conditions were collapsed, as they represented minor differences in the language-focused intervention. All children completed assessments at multiple time points during the academic year. Proximal measures (curriculum-aligned measures of vocabulary, comprehension monitoring, and understanding narrative and expository text) were administered throughout the school year. Distal measures of reading comprehension were administered at the beginning and the end of the school year. Results Multilevel multivariate regression was conducted with results showing that students receiving the language-focused intervention significantly outperformed those in the control group in comprehension monitoring and vocabulary, with effect sizes ranging from 0.55 to 1.98. A small effect in understanding text (narrative) was found in 3rd grade only. Multilevel path analyses were then conducted to examine if the intervention had a positive impact on reading comprehension through the influence of proximal language outcomes. In all 3 grades, instruction impacted reading comprehension via the mediation of vocabulary, with sizable effects (1.89-2.26); no other indirect pathways were significant. Conclusions This study provides evidence that a language-focused intervention can positively impact students' performance on language measures that are closely aligned with the intervention, with indirect, large effects on distal reading comprehension measures. Theoretically, this study provides causally interpretable support for the language bases of reading comprehension.",2019,"This study provides evidence that a language-focused intervention can positively impact students' performance on language measures that are closely aligned with the intervention, with indirect, large effects on distal reading comprehension measures.","[""primary grade students' proximal language skills and distal reading comprehension skills"", '938 children from 160 classrooms in 4 geographic regions in the United States; each classroom', 'Primary Grades']","['2 experimental conditions (2 variations of a language-focused intervention) or business-as-usual control', 'Language-Focused Classroom Intervention', 'language-focused classroom intervention']","['Proximal measures (curriculum-aligned measures of vocabulary, comprehension monitoring, and understanding narrative and expository text']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C3541382', 'cui_str': 'Text'}]",938.0,0.0378961,"This study provides evidence that a language-focused intervention can positively impact students' performance on language measures that are closely aligned with the intervention, with indirect, large effects on distal reading comprehension measures.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'Ohio State University, Columbus.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-19-0015']
176,31373537,Safety and immunogenicity of the therapeutic vaccine TG1050 in chronic hepatitis B patients: a phase 1b placebo-controlled trial.,"Treatment of chronic hepatitis B (CHB) typically requires life-long administration of drugs. Cohort and pre-clinical studies have established the link between a functional T-cell-mounted immunity and resolution of infection. TG1050 is an adenovirus 5-based vaccine that expresses HBV polymerase and domains of core and surface antigen and has shown immunogenicity and antiviral effects in mice. We performed a phase 1 clinical trial to assess safety and explore immunogenicity and early efficacy of TG1050 in CHB patients. This randomized, double blind, placebo-controlled study included two sequential phases: one single dose cohort (SD, n = 12) and one multiple (3) doses cohort (MD, n = 36). Patients, virally suppressed under nucleoside(d)tide analog NUC therapy, were randomized 1:1:1 across 3 dose levels (DL) and assigned to receive 10 9 , 10 10 , 10 11  virus particles (vp) of TG1050 and then randomized within each DL to placebo (3:1 and 9:3 vaccines/placebo in each DL, respectively, for the SD and MD cohorts). Cellular (ELISPOT) and antibody responses (anti-Adenovirus), as well as evolution of circulating HBsAg and HBcrAg, were monitored. All doses were well tolerated in both cohorts, without severe adverse event. TG1050 was capable to induce IFN-γ producing T-cells targeting 1 to 3 encoded antigens, in particular at the 10 10 vp dose. Overall, minor decreases of HBsAg were observed while a number of vaccinees reached unquantifiable HBcrAg by end of the study. In CHB patients under NUC, TG1050 exhibited a good safety profile and was capable to induce HBV-specific cellular immune response. These data support further clinical evaluation, especially in combination studies.",2020,"TG1050 was capable to induce IFN-γ producing T-cells targeting 1 to 3 encoded antigens, in particular at the 10 10 vp dose.","['2 sequential phases: one single dose cohort (SD, n=12) and one multiple (3) doses cohort (MD, n= 36', 'Chronic Hepatitis B Patients', 'CHB patients', 'Patients, virally suppressed under nucleoside(d)tide analog NUC therapy']","['TG1050', 'placebo (3:1 and 9:3 vaccines/placebo', 'placebo', 'Therapeutic Vaccine TG1050']","['Cellular (ELISPOT) and antibody responses (anti-Adenovirus', 'HBsAg', 'HBV-specific cellular immune response', 'Safety and Immunogenicity']","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.302419,"TG1050 was capable to induce IFN-γ producing T-cells targeting 1 to 3 encoded antigens, in particular at the 10 10 vp dose.","[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Zoulim', 'Affiliation': ""Service d'hépato-Gastroentérologie, Hospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fournier', 'Affiliation': ""Service d'Hépatologie, CHUM, Montreal, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Habersetzer', 'Affiliation': ""Service d'Hépato-Gastroentérologie, CHU, Strasbourg, France.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sprinzl', 'Affiliation': 'Medizinische Klinik und Poliklinik, Johannes Gutenberg Universität, Mainz, Germany.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Pol', 'Affiliation': 'Service Gastroentérologie et Hépatologie, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Carla S', 'Initials': 'CS', 'LastName': 'Coffin', 'Affiliation': 'Liver Unit, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Leroy', 'Affiliation': ""Service d'Hépato-Gastroentérologie, CHU, Grenoble, France.""}, {'ForeName': 'Mang', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Faculty of Medicine and Dentistry, Gastroenterology and Hepatology, Northern Alberta Clinical Trials and Research Centre, Edmonton, Canada.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Wedemeyer', 'Affiliation': 'Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'I. Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thimme', 'Affiliation': 'Uniklinik, Klinik für Innere Medizin II, Freiburg, Germany.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Lugardon', 'Affiliation': 'Deptartment Affaires Médicales, Reseach, Project, Transgene SA, Illkirch, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Deptartment Maladies Infectieuses, Transgene SA, Lyon, France.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Bastien', 'Affiliation': 'Deptartment Affaires Médicales, Reseach, Project, Transgene SA, Illkirch, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Sansas', 'Affiliation': 'Deptartment Affaires Médicales, Reseach, Project, Transgene SA, Illkirch, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Adda', 'Affiliation': 'Deptartment Affaires Médicales, Reseach, Project, Transgene SA, Illkirch, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Halluard', 'Affiliation': 'Deptartment Affaires Médicales, Reseach, Project, Transgene SA, Illkirch, France.'}, {'ForeName': 'Kaïdre', 'Initials': 'K', 'LastName': 'Bendjama', 'Affiliation': 'Deptartment Affaires Médicales, Reseach, Project, Transgene SA, Illkirch, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Brandely', 'Affiliation': 'Deptartment Affaires Médicales, Reseach, Project, Transgene SA, Illkirch, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Inchauspé', 'Affiliation': 'Deptartment Maladies Infectieuses, Transgene SA, Lyon, France.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1651141']
177,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND


Monotherapy with immune checkpoint inhibitors has generally been unsuccessful in men with advanced prostate cancer. Preclinical data support the notion that cryotherapy may improve immune-mediated and anti-tumor responses. The objective of this study was to assess the safety and feasibility of whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation in men with oligometastatic hormone-sensitive prostate cancer.
METHODS


This single-institution, pilot trial recruited 12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016. Patients underwent whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab (6 doses). The primary clinical endpoints were the number of patients with a PSA level of <0.6 ng/mL at one year and the frequency of adverse events. Other outcome measures included progression-free survival and systemic therapy-free survival. Exploratory analyses included PD-L1 protein expression.
RESULTS


Forty two percent (5/12) of patients had a PSAs of <0.6 ng/mL at one year though only 2 of these patients had recovered their testosterone at this time point. Median progression-free survival was 14 months, and median systemic therapy-free survival was 17.5 months. PD-L1 expression was not detectable by IHC in patients with evaluable tissue. All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
CONCLUSIONS


Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
178,32306247,Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial.,"INTRODUCTION


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


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


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


This short-term analysis, informed by the latest clinical trial evidence, demonstrated that degludec was a cost-effective treatment option relative to glargine U300. As such, our modelling analysis suggests that degludec would represent an efficient use of Dutch public healthcare resources in this patient population.",2020,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,[],"['Insulin Degludec Versus Insulin Glargine', 'insulin degludec 200\xa0units/mL (degludec) versus insulin glargine 300\xa0units/mL (glargine U300']","['severe hypoglycaemia rate', 'effectiveness [quality-adjusted life years (QALYs', 'Lower rates of non-severe nocturnal and severe hypoglycaemia', 'mean annual cost savings']",[],"[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.149607,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'University Hospital Llandough, Penarth, UK. marclyndon1@hotmail.com.'}, {'ForeName': 'Robert G J', 'Initials': 'RGJ', 'LastName': 'Moes', 'Affiliation': 'Novo Nordisk B.V., Alphen aan den Rijn, Netherlands.'}, {'ForeName': 'Katrine S', 'Initials': 'KS', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk Region Europe, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gundgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}]",Advances in therapy,['10.1007/s12325-020-01332-y']
179,32089436,Relationship Between Vascular Risk Factors and Location of Intracranial Atherosclerosis in the SAMMPRIS Trial.,"BACKGROUND


Previous studies have reported that different locations of intracranial atherosclerosis (ICAS) are associated with different demographic features and vascular risk factors. We aimed to examine this observation in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial population.
METHODS


SAMMPRIS was a randomized controlled trial that enrolled 451 patients with recent transient ischemic attack or stroke-related due to severe (70%-99%) stenosis of a major intracranial artery. We compared the baseline demographic features and vascular risk factors between the symptomatic artery locations. Wilcoxon test was used to compare continuous variables, and chi-square test was used for categorical variables.
RESULTS


Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation. Features that were significantly different between patients with anterior versus posterior ICAS were: median age (58.3 years versus 64.0 years, P < .001), males/females (52.9%/47.1% versus 74.4%/25.6% P < .001), white/black (66.8%/26.6% versus 79.4%/16.9%, P = .02), and history of hyperlipidemia (85.5% versus 92.5%, P = .03).
CONCLUSIONS


The observed differences in the distribution of demographic characteristics and vascular risk factors depending on the location of symptomatic ICAS suggest the possibility of different underlying pathological processes involved in the formation of atherosclerotic plaques in different locations.",2020,"RESULTS


Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation.","['enrolled 451 patients with recent transient ischemic attack or stroke-related due to severe (70%-99%) stenosis of a major intracranial artery', 'Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation']",[],['history of hyperlipidemia'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0447028', 'cui_str': 'Structure of intracranial artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]",[],"[{'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}]",451.0,0.203822,"RESULTS


Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation.","[{'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Al Kasab', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Yamada', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': ""Renee' H"", 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104713']
180,32113972,Pressure and Traction Technique Improves Postural Control More Than Tactile Stimulation in Foot Plantar Fascia: A Randomized Single-Blind Trial.,"OBJECTIVE


To check the acute effects of manual pressure and traction technique on balance and plantar footprint variables.
DESIGN


A single-blind clinical study with 2 groups.
SETTING


Private practice.
PARTICIPANTS


Healthy participants (N=40; 28 female and 12 male) were recruited to carry out a single-blind study.
INTERVENTIONS


Experimental group performed a bilateral plantar fascia manual pressure and traction technique. Control group performed a tactile stimulation. The position of the participant, the therapist, and the time of application of the techniques (5min) were the same for both interventions.
MAIN OUTCOME MEASURES


We measured stabilometry variables and static footprint. The footprint variables were divided in rear, middle, and front foot areas.
RESULTS


Significant differences were found in stabilometry variables. There was an improvement in experimental group at X displacement with eyes open (P=.014) and surface eyes closed (P=.046) variables.
CONCLUSIONS


After technique the experimental group improved the stabilometry variables, specifically surface with eyes closed and X displacement with eyes open. The static footprint variables have not shown differences after the technique compared with the control group.",2020,"There was an improvement in experimental group at X displacement with eyes open (p=0.014) and surface eyes closed (p=0.046) variables.
","['Forty healthy participants (28 females and 12 males', 'foot plantar fascia']","['Pressure and Traction technique improve Postural Control more than tactile stimulation', 'bilateral plantar fascia manual pressure and traction technique', 'tactile stimulation', 'manual pressure and traction technique']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1562800', 'cui_str': 'Traction technique (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]",[],40.0,0.0202167,"There was an improvement in experimental group at X displacement with eyes open (p=0.014) and surface eyes closed (p=0.046) variables.
","[{'ForeName': 'Eva María', 'Initials': 'EM', 'LastName': 'Martínez-Jiménez', 'Affiliation': 'Faculty of Physiotherapy and Nursing, Castilla la Mancha University, Toledo, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Becerro-de-Bengoa-Vallejo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Marta Elena', 'Initials': 'ME', 'LastName': 'Losa-Iglesias', 'Affiliation': 'Faculty of Health Sciences, Universidad Rey Juan Carlos, Alcorcon, Spain.'}, {'ForeName': 'José Ignacio', 'Initials': 'JI', 'LastName': 'Díaz-Velázquez', 'Affiliation': 'Rehabilitación Premium Madrid, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palomo-López', 'Affiliation': 'Department of Nursing, University Center of Plasencia, Plasencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain. Electronic address: davidrodriguezsanz@ucm.es.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group, Department of Health Sciences, Faculty of Nursing and Podriarty, Universidade da Coruña, Ferrol, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.01.017']
181,31451009,Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome.,"Background Metabolic syndrome (MetS) is a serious health problem over the world; thus, the aim of the present work was to develop a lifestyle intervention to decrease the dysbiosis of gut microbiota and reduce the biochemical abnormalities of MetS. Methods and Results The prevalence of MetS was evaluated in 1065 subjects of Mexico City, Mexico, and the gut microbiota in a subsample. Subjects with MetS were selected for a pragmatic study based on a lifestyle intervention with a low-saturated-fat diet, reduced-energy intake, with functional foods and physical activity, and a second group was selected for a randomized control-placebo study to assess the gut microbiota after the dietary intervention. Prevalence of MetS was 53%, and the higher the body mass index, the higher the gut microbiota dysbiosis. The higher the Homeostatic Model Assessment for Insulin Resistance, the lower the high-density lipoprotein cholesterol concentration. The pragmatic study revealed that after 15 days on a low-saturated-fat diet, there was a 24% reduction in serum triglycerides; and after a 75-day lifestyle intervention, MetS was reduced by 44.8%, with a reduction in low-density lipoprotein cholesterol, small low-density lipoprotein particles, glucose intolerance, lipopolysaccharide, and branched-chain amino acid. The randomized control-placebo study showed that after the lifestyle intervention, there was a decrease in the dysbiosis of the gut microbiota associated with a reduction in the Prevotella/ Bacteroides ratio and an increase in the abundance of Akkermansia muciniphila and Faecalibacterium prausnitzii. Conclusions A lifestyle intervention significantly decreased MetS components, small low-density lipoprotein particle concentration, gut microbiota dysbiosis, and metabolic endotoxemia, reducing the risk of atherosclerosis. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT03611140.",2019,"Prevalence of MetS was 53%, and the higher the body mass index, the higher the gut microbiota dysbiosis.","['Subjects with MetS', 'Subjects With Metabolic Syndrome', '1065 subjects of Mexico City, Mexico, and the gut microbiota in a subsample']","['lifestyle intervention with a low-saturated-fat diet, reduced-energy intake, with functional foods and physical activity', 'placebo', 'Lifestyle Intervention']","['abundance of Akkermansia muciniphila and Faecalibacterium prausnitzii', 'high-density lipoprotein cholesterol concentration', 'serum triglycerides', 'MetS components, small low-density lipoprotein particle concentration, gut microbiota dysbiosis, and metabolic endotoxemia, reducing the risk of atherosclerosis', 'Prevalence of MetS', 'dysbiosis of the gut microbiota', 'low-density lipoprotein cholesterol, small low-density lipoprotein particles, glucose intolerance, lipopolysaccharide, and branched-chain amino acid', 'Lipoprotein Profile and Metabolic Endotoxemia']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C2717755', 'cui_str': 'Functional Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}, {'cui': 'C0317558', 'cui_str': 'Fusobacterium prausnitzii'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0376618', 'cui_str': 'Endotoxemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0002521', 'cui_str': 'Amino Acids, Branched-Chain'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]",1065.0,0.0382502,"Prevalence of MetS was 53%, and the higher the body mass index, the higher the gut microbiota dysbiosis.","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Guevara-Cruz', 'Affiliation': 'Departamento de Fisiología de la Nutrición Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico.'}, {'ForeName': 'Adriana G', 'Initials': 'AG', 'LastName': 'Flores-López', 'Affiliation': 'Departamento de Fisiología de la Nutrición Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Aguilar-López', 'Affiliation': 'Departamento de Fisiología de la Nutrición Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Sánchez-Tapia', 'Affiliation': 'Departamento de Fisiología de la Nutrición Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Medina-Vera', 'Affiliation': 'Departamento de Fisiología de la Nutrición Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Díaz', 'Affiliation': 'Centro de Ciencias de la Complejidad Universidad Nacional Autónoma de México Mexico City Mexico.'}, {'ForeName': 'Armando R', 'Initials': 'AR', 'LastName': 'Tovar', 'Affiliation': 'Departamento de Fisiología de la Nutrición Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico.'}, {'ForeName': 'Nimbe', 'Initials': 'N', 'LastName': 'Torres', 'Affiliation': 'Departamento de Fisiología de la Nutrición Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.012401']
182,32306462,"Reduction in Migraine and Headache Frequency and Intensity With Combined Antioxidant Prophylaxis (N-acetylcysteine, Vitamin E, and Vitamin C): A Randomized Sham-Controlled Pilot Study.","OBJECTIVE


To investigate the preventive effects of a combined antioxidant drug (N-acetylcysteine, vitamin E, and vitamin C [NEC]) on migraine outcomes. Migraine is characterized by increased oxidative stress and neurogenic inflammation in the brain; therefore, antioxidants may have a migraine preventive effect.
DESIGN


Randomized, double-blind, sham-controlled pilot study.
SETTING


Australian community.
SUBJECTS


Adults reporting 2 to 8 migraines per month for at least a year.
METHODS


After a 1-month baseline period, 35 subjects completed 3 months of treatment with NEC (n = 19) or sham (n = 16) capsules. The primary outcome was the difference in mean number of headaches per month between baseline and final month of the trial for NEC and sham groups; secondary outcomes are listed below.
RESULTS


For NEC there was a significant decrease in mean number of headaches by 3.0 per month (P = 0.004) compared with 1.4 for sham (P = 0.073); there was no significant difference in these changes between the 2 groups (P = 0.052). Average monthly headache (P = 0.041) and migraine frequency (P = 0.018) were significantly less for NEC vs. sham. In NEC subjects, there was a significant decrease in average monthly migraine days (-3.1), moderate/severe headache days (-3.2), migraine duration, headache pain scores, and acute headache medication use.
CONCLUSIONS


This is the first randomized controlled trial to find that combined antioxidant therapy with NEC reduces headaches and migraines in adult migraineurs. Given the limitations of this pilot study, an adequately powered randomized controlled trial is planned to further investigate antioxidant prophylaxis in migraine.",2020,Average monthly headache (p = .041) and migraine frequency (p = .018) were significantly less for NEC versus sham.,"['Australian community', 'adult migraineurs', 'Adults reporting 2-8 migraines per month for at least a year']","['combined antioxidant drug known as NEC (N-acetylcysteine, Vitamin E and C', 'NEC', 'Combined Antioxidant Prophylaxis (N-acetylcysteine, Vitamin E and Vitamin C: NEC']","['migraine frequency', 'average monthly migraine days (-3.1), moderate/severe headache days (-3.2), migraine duration, headache pain scores and acute headache medication use', 'migraine outcomes', 'headaches and migraines', 'Average monthly headache', 'mean number of headaches']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",35.0,0.324419,Average monthly headache (p = .041) and migraine frequency (p = .018) were significantly less for NEC versus sham.,"[{'ForeName': 'Eric John', 'Initials': 'EJ', 'LastName': 'Visser', 'Affiliation': 'School of Medicine, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Drummond', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Julia L A', 'Initials': 'JLA', 'LastName': 'Lee-Visser', 'Affiliation': 'School of Medicine, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12902']
183,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma.
METHODS


It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months.
RESULTS


In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months.
CONCLUSION


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
184,27389436,"Participation in a randomised controlled feasibility study of a complex intervention for the management of the Respiratory Symptom Distress Cluster in lung cancer: patient, carer and research staff views.","This paper reports finding from a nested qualitative study designed to elicit the views and perceptions of those who participated in a randomised controlled feasibility trial testing a non-pharmacological intervention, Respiratory Distress Symptom Intervention (RDSI), for the management of the breathlessness-cough-fatigue symptom cluster in lung cancer. Semi-structured interviews were conducted with 11 lung cancer patients, three caregivers and seven researchers involved in recruitment, consent, RDSI training and delivery and participant follow-up. Thematic analysis identified key considerations including: the importance of informed consent emphasising commitment to completion of paperwork and raising awareness of potential sensitivities relating to content of questionnaires; ensuring screening for the presence of symptoms reflects the language used by patients; appreciation of the commitment required from participants to learn intervention techniques and embed them as part of everyday life; conduct of interviews with patients who decline to participate; and conduct of serial interviews with those receiving RDSI to further inform its routine implementation into clinical practice. This study will inform the development of a fully powered follow-on trial testing the hypothesis that RDSI plus usual care is superior to usual care alone in the effective management of this symptom cluster in lung cancer.",2017,This study will inform the development of a fully powered follow-on trial testing the hypothesis that RDSI plus usual care is superior to usual care alone in the effective management of this symptom cluster in lung cancer.,"['11 lung cancer patients, three caregivers and seven researchers involved in recruitment, consent, RDSI training and delivery and participant follow-up', 'lung cancer']","['non-pharmacological intervention, Respiratory Distress Symptom Intervention (RDSI', 'complex intervention']",[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]",[],11.0,0.041486,This study will inform the development of a fully powered follow-on trial testing the hypothesis that RDSI plus usual care is superior to usual care alone in the effective management of this symptom cluster in lung cancer.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ellis', 'Affiliation': 'Health Services Research, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Warden', 'Affiliation': 'School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mackereth', 'Affiliation': 'School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lloyd-Williams', 'Affiliation': 'Health Services Research, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Burns', 'Affiliation': 'School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yorke', 'Affiliation': 'School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}]",European journal of cancer care,['10.1111/ecc.12538']
185,32205026,Effects of Action Observation Training with Auditory Stimulation on Static and Dynamic Balance in Chronic Stroke Patients.,"PURPOSE


The purpose of this study was to investigate the effects of action observation physical training accompanied by rhythmic auditory stimulation on the balance abilities of patients with stroke.
METHOD


In total, 30 patients with stroke at more than 6 months after the onset of the disease were included in the present investigation. Experimental programs were employed for 30 minutes a day, 3 times a week for 8 weeks. The audiovisual action observation training (AAO) group received action observation training with rhythmic auditory stimulation at a comfortable speed and physical training, and the visual action observation training (VAO) group received action observation training and physical training. The balance was assessed using a Biodex balance system.
RESULTS


In overall balance index, anteroposterior balance index, mediolateral balance index, and fall risk, there were significant improvements in both groups after intervention. A greater degree of changes were observed in the AAO group than those in the VAO group (P< .05).
CONCLUSIONS


The simultaneous application of action observation physical training and rhythmic auditory training seems to be an effective treatment method for patients with stroke. Furthermore, it is presented as a more effective therapeutic intervention method for those with motor disorders, such as patients with stroke.",2020,"In overall balance index, anteroposterior balance index, mediolateral balance index, and fall risk, there were significant improvements in both groups after intervention.","['30 patients with stroke at more than 6 months after the onset of the disease were included in the present investigation', 'Chronic Stroke Patients', 'patients with stroke']","['action observation physical training and rhythmic auditory training', 'Action Observation Training with Auditory Stimulation', 'action observation physical training accompanied by rhythmic auditory stimulation', 'audiovisual action observation training (AAO) group received action observation training with rhythmic auditory stimulation at a comfortable speed and physical training, and the visual action observation training (VAO) group received action observation training and physical training']","['Static and Dynamic Balance', 'overall balance index, anteroposterior balance index, mediolateral balance index, and fall risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Auditory'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}]",30.0,0.0116923,"In overall balance index, anteroposterior balance index, mediolateral balance index, and fall risk, there were significant improvements in both groups after intervention.","[{'ForeName': 'HoYoung', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Science, Graduate School, Daegu University, Gyeongsan-si, Gyeongsangbuk-do 38453, Republic of Korea. Electronic address: welove24@naver.com.'}, {'ForeName': 'Kyoung', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College Rehabilitation Science, Daegu University, Gyeongsan-si, Gyeongsangbuk-do 38453, Republic of Korea. Electronic address: kykim257@hanmail.net.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104775']
186,32171774,The Impact of Levothyroxine on Cardiac Function in Older Adults With Mild Subclinical Hypothyroidism: A Randomized Clinical Trial.,"BACKGROUND


Subclinical hypothyroidism has been associated with heart failure, but only small trials assessed whether treatment with levothyroxine has an impact on cardiac function.
METHODS


In a randomized, double-blind, placebo-controlled, trial nested within the TRUST trial, Swiss participants ages ≥65 years with subclinical hypothyroidism (thyroid-stimulating hormone [TSH] 4.60-19.99 mIU/L; free thyroxine level within reference range) were randomized to levothyroxine (starting dose of 50 µg daily) to achieve TSH normalization or placebo. The primary outcomes were the left ventricular ejection fraction for systolic function and the ratio between mitral peak velocity of early filling to early diastolic mitral annular velocity (E/e' ratio) for diastolic function. Secondary outcomes included e' lateral/septal, left atrial volume index, and systolic pulmonary artery pressure.
RESULTS


A total of 185 participants (mean age 74.1 years, 47% women) underwent echocardiography at the end of the trial. After a median treatment duration of 18.4 months, the mean TSH decreased from 6.35 mIU/L to 3.55 mIU/L with levothyroxine (n = 96), and it remained elevated at 5.29 mIU/L with placebo (n = 89). The adjusted between-group difference was not significant for the mean left ventricular ejection fraction (62.7% vs 62.5%, difference = 0.4%, 95% confidence interval -1.8% to 2.5%, P = 0.72) and the E/e' ratio (10.6 vs 10.1, difference 0.4, 95% confidence interval -0.7 to 1.4, P = 0.47). No differences were found for the secondary diastolic function parameters or for interaction according to sex, baseline TSH, preexisting heart failure, and treatment duration (P value >0.05).
CONCLUSION


Systolic and diastolic heart function did not differ after treatment with levothyroxine compared with placebo in older adults with mild subclinical hypothyroidism.",2020,"No differences were found for the secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration (P-value >0.05).
","['mean age 74.1 years, 47% women) underwent', '185 participants ', 'Older Adults with Mild Subclinical Hypothyroidism', 'older adults with mild subclinical hypothyroidism', 'Swiss participants aged ≥65 years with subclinical hypothyroidism (thyroid-stimulating hormone, TSH, 4.60-19.99 mIU/L; free thyroxine level within reference range']","['TSH normalization, or placebo', 'placebo', 'Levothyroxine', 'echocardiography', 'levothyroxine']","[""e' lateral/septal, left atrial volume index and systolic pulmonary artery pressure"", 'mean TSH', 'mean left ventricular ejection fraction', 'secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration', 'Cardiac Function', ""left ventricular ejection fraction for systolic function, and the ratio between mitral peak velocity of early filling to early diastolic mitral annular velocity (E/e' ratio) for diastolic function"", 'Systolic and diastolic heart function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0439462', 'cui_str': 'milliinternational unit/liter'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0460094', 'cui_str': 'Within reference range (qualifier value)'}]","[{'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C4521692', 'cui_str': 'Cardiac physiological function (observable entity)'}]",185.0,0.763923,"No differences were found for the secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration (P-value >0.05).
","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""Service of Cardiology, University Hospitals of Geneva, University of Geneva, Switzerland; TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Department of Health Research & Policy, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Delgiovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Buffle', 'Affiliation': 'Department of Cardiology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Monney', 'Affiliation': 'Service of Cardiology, Department of Heart and Vessels, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gabus', 'Affiliation': 'Service of Cardiology, Department of Heart and Vessels, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Service of Cardiology, University Hospitals of Geneva, University of Geneva, Switzerland.'}, {'ForeName': 'Gerasimos P', 'Initials': 'GP', 'LastName': 'Sykiotis', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kearney', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Center for Healthy Aging, University of Copenhagen, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, UK.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'University of San Francisco, California, United States.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: nicolas.rodondi@insel.ch.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.01.018']
187,32173228,Effect of Health Education on Level of Awareness and Knowledge of Nigerian In-School adolescents on Stroke and Its Risk Factors.,"BACKGROUND


Stroke education in adolescents has been established as an effective method of creating awareness about stroke, its warning signs and risk factors. It contributes to desired behavioural change in the adolescents as well as their parents. Thus, we aimed to determine the baseline knowledge of school attending adolescents about stroke and its risk factors as well as the effect of stroke education on their stroke awareness.
METHODS


This study employed a quasi-experimental study design and was conducted in secondary schools in Ile-Ife, Osun State, Nigeria. The schools were divided into intervention and control groups. We assessed the baseline knowledge of the students on stroke, its risk factors, warning signs, and ways of preventing it using a pre-tested structured questionnaire in both intervention and control groups. In the intervention group, health talks on stroke consisting of oral presentation and distribution of fliers were presented for 30 minutes in each selected school. Each school was visited 2 weeks after the health education intervention to assess their knowledge on stroke, its risk factors, and ways of preventing it. The control group was also visited after 2 weeks for a re-assessment of their stroke knowledge and the conduct of heath talk on other aspects of neurology such as sleep, epilepsy, etc. Results: A total of 1259 adolescents were studied with 661 in the intervention group and 598 in the control group. The mean age of the respondents was 13.56 ± 2.87 the intervention group and 13.38 ± 2.06 in the control group. There were higher mean scores on knowledge of stroke and its risk factors among the intervention group than seen in the control group after the stroke education.
CONCLUSIONS


Stroke education is an effective way of creating and maintaining stroke awareness among school-attending adolescents.",2020,"There were higher mean scores on knowledge of stroke and its risk factors among the intervention group than seen in the control group after the stroke education.
","['1259 adolescents were studied with 661 in the intervention group and 598 in the control group', 'school-attending adolescents', 'secondary schools in Ile-Ife, Osun State, Nigeria', 'school attending adolescents']",['Health Education'],"['knowledge of stroke and its risk factors', 'Level of Awareness and Knowledge of Nigerian']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C1611269', 'cui_str': 'Immunofixation electrophoresis (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}]",[{'cui': 'C0018701'}],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C1556089', 'cui_str': 'Nigerians (ethnic group)'}]",1259.0,0.0165883,"There were higher mean scores on knowledge of stroke and its risk factors among the intervention group than seen in the control group after the stroke education.
","[{'ForeName': 'Morenikeji A', 'Initials': 'MA', 'LastName': 'Komolafe', 'Affiliation': 'Department of Internal Medicine, Obafemi Awolowo University/Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Nigeria.'}, {'ForeName': 'Oluwatosin E', 'Initials': 'OE', 'LastName': 'Olorunmoteni', 'Affiliation': 'Department of Paediatrics and Child Health, Obafemi Awolowo University/Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria. Electronic address: doc_tosino@yahoo.com.'}, {'ForeName': 'Funmito O', 'Initials': 'FO', 'LastName': 'Fehintola', 'Affiliation': 'Department of Community Health, Obafemi Awolowo University/Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104757']
188,32306747,Clinical Effectiveness Trial of Adjunctive Interpersonal and Social Rhythm Therapy for Patients With Bipolar Disorder.,"OBJECTIVE


This study compared relapse rates at 18 months among patients with bipolar disorder who, after discharge from publicly funded mental health services, received either adjunctive interpersonal and social rhythm therapy (IPSRT) or treatment as usual (general practice medical care).
METHODS


Patients diagnosed as having a bipolar I or II disorder who had been discharged from publicly funded mental health services in New Zealand during the previous 3 months were randomly assigned to 18 months of IPSRT or to treatment as usual. The primary outcome measure was the Life Interval Follow-Up Evaluation (LIFE) completed at weeks 26, 52, and 78 of treatment. Secondary measures were scores on the Social Adjustment Scale (SAS) and the Quality of Life-Bipolar Disorder Scale (QoL-BD) and readmission to mental health services.
RESULTS


The sample consisted of 88 patients. In this intention-to-treat analysis, no significant differences were observed in rates of mood episodes between the groups (odds ratio=0.93, 95% confidence interval=0.37-2.17, p=0.86). A statistically significant difference was seen between the intervention and treatment-as-usual groups in scores on the SAS (effect size=0.5) but not on the QoL-BD. A significantly lower readmission rate was observed among the intervention group.
CONCLUSIONS


This pragmatic clinical effectiveness trial found that a combination of IPSRT and medication management over 18 months did not significantly improve mood relapse but did improve patient functioning.",2020,A statistically significant difference was seen between the intervention and treatment-as-usual groups in scores on the SAS (effect size=0.5) but not on the QoL-BD.,"['Patients diagnosed as having a bipolar I or II disorder who had been discharged from publicly funded mental health services in New Zealand during the previous 3 months', 'Patients With Bipolar Disorder', '88 patients', 'patients with bipolar disorder who, after discharge from publicly funded mental health services']","['adjunctive interpersonal and social rhythm therapy (IPSRT) or treatment as usual (general practice medical care', 'Adjunctive Interpersonal and Social Rhythm Therapy', 'IPSRT']","['Life Interval Follow-Up Evaluation (LIFE', 'mood relapse', 'relapse rates', 'readmission rate', 'scores on the Social Adjustment Scale (SAS) and the Quality of Life-Bipolar Disorder Scale (QoL-BD) and readmission to mental health services', 'rates of mood episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.122957,A statistically significant difference was seen between the intervention and treatment-as-usual groups in scores on the SAS (effect size=0.5) but not on the QoL-BD.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Crowe', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Porter', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Inder', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Carlyle', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Luty', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Lacey', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}]",American journal of psychotherapy,['10.1176/appi.psychotherapy.20190035']
189,31864932,Laser ablation versus mechanochemical ablation in the treatment of primary varicose veins: A randomized clinical trial.,"OBJECTIVE


to prospectively compare the surgical outcome of using endovenous laser ablation (EVLA) and mechanochemical ablation (MOCA) in management of patients with primary varicose veins (VV).
METHODS


The present study prospectively recruited 100 patients with primary VV. They were randomly and equally allocated to one of two treatment group: the EVLA group (n = 50) or the MOCA group (n = 50). Before intervention, all patients underwent to clinical and ultrasound assessment of the vascular system. The Venous Clinical Severity Score was used to assess clinical severity. In addition, patients completed the Chronic Venous Insufficiency Questionnaire. The primary study outcome was treatment success. After intervention, patients were followed up at 1 week, 1 months, 6 months, and 12 months.
RESULTS


Operative success was achieved in all patients. The MOCA group had a significantly shorter operative time when compared with EVLA group. The Venous Clinical Severity Score significantly improved in both groups over the follow-up period and showed significantly lower levels in the MOCA group. Perceived pain was significantly improved in both groups postoperatively with no significant differences. The Chronic Venous Insufficiency Questionnaire was significantly improved after 12 months of operation without significant differences between groups. MOCA patients had significantly lower rate of postoperative phlebitis and significantly shorter time to return to work.
CONCLUSIONS


MOCA for primary VV is a feasible, effective, and safe procedure with better clinical outcome and lower rate of postoperative phlebitis when compared with EVLA.",2020,The Venous Clinical Severity Score significantly improved in both groups over the follow-up period and showed significantly lower levels in the MOCA group.,"['100 patients with primary VV', 'primary varicose veins', 'patients with primary varicose veins (VV']","['endovenous laser ablation (EVLA) and mechanochemical ablation (MOCA', 'Laser ablation versus mechanochemical ablation', 'MOCA', 'EVLA']","['postoperative phlebitis', 'Perceived pain', 'rate of postoperative phlebitis', 'Chronic Venous Insufficiency Questionnaire', 'Venous Clinical Severity Score', 'Operative success', 'operative time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042345', 'cui_str': 'Varices'}]","[{'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1306557', 'cui_str': 'Chronic venous insufficiency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",100.0,0.0577375,The Venous Clinical Severity Score significantly improved in both groups over the follow-up period and showed significantly lower levels in the MOCA group.,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Tawfik', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine, Zagazig University, Zagazig, Sharqiyah, Egypt. Electronic address: tawfik2carotid@yahoo.com.'}, {'ForeName': 'Waleed A', 'Initials': 'WA', 'LastName': 'Sorour', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine, Zagazig University, Zagazig, Sharqiyah, Egypt.'}, {'ForeName': 'Medhat E', 'Initials': 'ME', 'LastName': 'El-Laboudy', 'Affiliation': 'Department of Vascular Surgery, Faculty of Medicine, Zagazig University, Zagazig, Sharqiyah, Egypt.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2019.10.025']
190,32115341,"Effect of Early and Intensive Rehabilitation after Ischemic Stroke on Functional Recovery of the Lower Limbs: A Pilot, Randomized Trial.","OBJECTIVE


We aimed to develop an early and intense lower extremity training technique using a recumbent cycle ergometer system in patients with acute ischemic stroke.
METHODS


This was a pilot, prospective, randomized, controlled study with 2 parallel groups followed for 3 months with blinded assessment of outcomes. Thirty-one eligible patients were randomized to experimental and control groups. To strengthen the motion of the lower extremities within 48 hours after stroke, the control and experimental groups received conventional treatment and additional interventions under a therapist's guidance combined with conventional treatment, respectively. The primary outcome measure was the change in lower extremity motor control from admission to 4 weeks, assessed by the Fugl-Meyer Assessment. Secondary outcomes were the number of days to walking 50 m and the change in the Berg Balance Scale score and Barthel index. The modified Rankin Score was used to assess the overall function and prognosis at 3 months.
RESULTS


Fugl-Meyer Assessment and Berg Balance Scale scores and Barthel index increased over time in the experimental group, as did the Berg Balance Scale score and Barthel index in the control group (P < .001). However, Fugl-Meyer Assessment scores in the control group were similar over time (F = 2.303, P = 1.119). Fugl-Meyer Assessment scores in the experimental group were higher than those in the control group after 2 and 4 weeks (P = .084 and .037, respectively). Compared with the control group at 2 weeks or at discharge, the percentage of patients who returned to unassisted walking in the experimental group showed an increasing trend (56.3% versus 26.67%, P = .095), but there was no significant difference between the 2 groups after 3 months (P = .598). The modified Rankin Score at 3 months showed no significant difference between the 2 groups (P > .05).
CONCLUSIONS


Our early and intense lower extremity training technique involving a leg cycle ergometer system contributes to the recovery of lower extremity function in patients with acute ischemic stroke. This finding will provide a basis for future investigations on the applicability of the intervention in early lower extremity and walking rehabilitation among individuals with neurological disorder.",2020,"Fugl-Meyer Assessment scores in the experimental group were higher than those in the control group after 2 and 4 weeks (P = .084 and .037, respectively).","['Thirty-one eligible patients', 'patients with acute ischemic stroke', 'individuals with neurological disorder', 'Lower Limbs']","['Early and Intensive Rehabilitation', 'extremity training technique using a recumbent cycle ergometer system']","['Fugl-Meyer Assessment scores', 'Berg Balance Scale score and Barthel index', 'Fugl-Meyer Assessment and Berg Balance Scale scores and Barthel index', 'modified Rankin Score', 'number of days to walking 50 m and the change in the Berg Balance Scale score and Barthel index', 'change in lower extremity motor control from admission to 4 weeks, assessed by the Fugl-Meyer Assessment']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",31.0,0.0605137,"Fugl-Meyer Assessment scores in the experimental group were higher than those in the control group after 2 and 4 weeks (P = .084 and .037, respectively).","[{'ForeName': 'Wen-Xiu', 'Initials': 'WX', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China. Electronic address: lisa787878@163.com.'}, {'ForeName': 'Cheng-Ye', 'Initials': 'CY', 'LastName': 'Zhou', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China; Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China.'}, {'ForeName': 'Zhe-Wei', 'Initials': 'ZW', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China.'}, {'ForeName': 'Guo-Qian', 'Initials': 'GQ', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China.'}, {'ForeName': 'Hai-Min', 'Initials': 'HM', 'LastName': 'Jin', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China.'}, {'ForeName': 'Dong-Rui', 'Initials': 'DR', 'LastName': 'He', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, ZheJiang, China.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104649']
191,31335759,Impact of a Mobile Health Intervention on Long-term Nonadherence After Lung Transplantation: Follow-up After a Randomized Controlled Trial.,"BACKGROUND


In a randomized controlled trial, lung transplant recipients (LTRs) using a mobile health intervention, Pocket Personal Assistant for Tracking Health (Pocket PATH), showed better adherence to the medical regimen than LTRs receiving usual care during the first year posttransplant. We examined whether these effects were maintained beyond the end of the trial and evaluated other potential risk factors for long-term nonadherence.
METHODS


Adherence in 8 areas was evaluated at follow-up in separate LTR and family caregiver (collateral) assessments. Pocket PATH and usual care groups' nonadherence rates were compared; multivariable regression analyses then examined and controlled for other patient characteristics' associations with nonadherence.
RESULTS


One hundred five LTRs (75% of survivors) were assessed (M = 3.9 years posttransplant, SD = 0.8). Nonadherence rates in the past month were 23%-81% for self-care and lifestyle requirements (diet, exercise, blood pressure monitoring, spirometry), 13%-23% for immunosuppressants and other medications, and 4% for tobacco use, with 31% clinic appointment nonadherence in the past year. In multivariable analysis, the Pocket PATH group showed lower risk of nonadherence to lifestyle requirements (diet/exercise) than the usual care group (P < 0.05). Younger age and factors during the first year posttransplant (acute graft rejection, chronically elevated anxiety, less time rehospitalized, nonadherence at the final randomized controlled trial assessment) were each associated with nonadherence in at least 1 area at follow-up (P < 0.05).
CONCLUSIONS


Pocket PATH did not have sustained impact on most areas of the regimen, although we identified other risk factors for long-term nonadherence. Future work should explore strategies to facilitate sustained effects of mobile health interventions.",2020,"In multivariable analysis, the Pocket PATH group showed lower risk of nonadherence to lifestyle requirements (diet/exercise) than the usual care group (p<.05).",['lung transplant recipients (LTRs'],"['Mobile Health Intervention', 'mobile health intervention, Pocket Personal Assistant for Tracking Health (Pocket PATH']","['risk of nonadherence to lifestyle requirements', 'Nonadherence rates', 'Long-Term Nonadherence']","[{'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0401893', 'cui_str': 'Personal assistant (occupation)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.066972,"In multivariable analysis, the Pocket PATH group showed lower risk of nonadherence to lifestyle requirements (diet/exercise) than the usual care group (p<.05).","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Geramita', 'Affiliation': 'Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'DeVito Dabbs', 'Affiliation': 'Department of Acute and Tertiary Care, University of Pittsburgh School of Nursing, Pittsburgh, PA.'}, {'ForeName': 'Andrea F', 'Initials': 'AF', 'LastName': 'DiMartini', 'Affiliation': 'Departments of Psychiatry and Surgery, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Pilewski', 'Affiliation': 'Departments of Medicine, Pediatrics, and Cell Biology, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Galen E', 'Initials': 'GE', 'LastName': 'Switzer', 'Affiliation': 'Department of Medicine, University of Pittsburgh, and Center for Health Equity Research and Promotion, Veterans Administration Pittsburgh Healthcare System, Pittsburgh, PA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Posluszny', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Myaskovsky', 'Affiliation': 'Department of Internal Medicine, and Center for Healthcare Equity in Kidney Disease, University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Mary Amanda', 'Initials': 'MA', 'LastName': 'Dew', 'Affiliation': 'Departments of Psychiatry, Psychology, Epidemiology, Biostatistics, Nursing, and Clinical and Translational Science, University of Pittsburgh, Pittsburgh, PA.'}]",Transplantation,['10.1097/TP.0000000000002872']
192,31819291,Provider and household costs of  Plasmodium vivax  malaria episodes: a multicountry comparative analysis of primary trial data.,"Objective


To determine household and health-care provider costs associated with  Plasmodium vivax  infection across a range of endemic settings.
Methods


We collected cost data alongside three multicentre clinical trials of  P. vivax  treatment in Afghanistan, Brazil, Colombia, Ethiopia, Indonesia, Philippines, Peru, Thailand and Viet Nam conducted between April 2014 to December 2017. We derived household costs from trial participant surveys administered at enrolment and again 2 weeks later to determine the costs of treatment and transportation, and the number of days that patients and their household caregivers were unable to undertake their usual activities. We determined costs of routine care by health-care providers by micro-costing the resources used to diagnose and treat  P. vivax  at the study sites.
Findings


The mean total household costs ranged from 8.7 United States dollars (US$; standard deviation, SD: 4.3) in Afghanistan to US$ 254.7 (SD: 148.4) in Colombia. Across all countries, productivity losses were the largest household cost component, resulting in mean indirect costs ranging from US$ 5.3 (SD: 3.0) to US$ 220.8 (SD: 158.40). The range of health-care provider costs for routine care was US$ 3.6-6.6. The cost of administering a glucose-6-phosphate-dehydrogenase rapid diagnostic test, ranged from US$ 0.9 to 13.5, consistently lower than the costs of the widely-used fluorescent spot test (US$ 6.3 to 17.4).
Conclusion


An episode of  P. vivax  malaria results in high costs to households. The costs of diagnosing and treating  P. vivax  are important inputs for future cost-effectiveness analyses to ensure optimal allocation of resources for malaria elimination.",2019,The costs of diagnosing and treating  P. vivax  are important inputs for future cost-effectiveness analyses to ensure optimal allocation of resources for malaria elimination.,"['Afghanistan, Brazil, Colombia, Ethiopia, Indonesia, Philippines, Peru, Thailand and Viet Nam conducted between April 2014 to December 2017']",[],"['range of health-care provider costs', 'mean total household costs']","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020052', 'cui_str': 'Households'}]",,0.0635265,The costs of diagnosing and treating  P. vivax  are important inputs for future cost-effectiveness analyses to ensure optimal allocation of resources for malaria elimination.,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory 0811, Australia.'}, {'ForeName': 'Ayodhia P', 'Initials': 'AP', 'LastName': 'Pasaribu', 'Affiliation': 'Medical Faculty, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Tedlla', 'Initials': 'T', 'LastName': 'Teferi', 'Affiliation': 'Arba Minch Hospital, Arba Minch, Ethiopia.'}, {'ForeName': 'Huong-Thu', 'Initials': 'HT', 'LastName': 'Pham', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ghulam Rahim', 'Initials': 'GR', 'LastName': 'Awab', 'Affiliation': 'Medical Faculty, Nangarhar University, Kabul, Afghanistan.'}, {'ForeName': 'Febrina', 'Initials': 'F', 'LastName': 'Contantia', 'Affiliation': 'Tanjung Leidong Health Center, Tanjung Leidong, Indonesia.'}, {'ForeName': 'Thuy-Nhien', 'Initials': 'TN', 'LastName': 'Nguyen', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Viet-Thanh', 'Initials': 'VT', 'LastName': 'Ngo', 'Affiliation': 'Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Tinh-Hien', 'Initials': 'TH', 'LastName': 'Tran', 'Affiliation': 'Oxford University Clinical Research Unit, University of Oxford, Oxford, England.'}, {'ForeName': 'Asrat', 'Initials': 'A', 'LastName': 'Hailu', 'Affiliation': 'School of Medicine, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Gilchrist', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, United States of America.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Green', 'Affiliation': 'GlaxoSmithKline Research & Development, Uxbridge, England.'}, {'ForeName': 'Gavin Ckw', 'Initials': 'GC', 'LastName': 'Koh', 'Affiliation': 'GlaxoSmithKline Research & Development, Uxbridge, England.'}, {'ForeName': 'Kamala', 'Initials': 'K', 'LastName': 'Thriemer', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory 0811, Australia.'}, {'ForeName': 'Walter Rj', 'Initials': 'WR', 'LastName': 'Taylor', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nicholas Pj', 'Initials': 'NP', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ric N', 'Initials': 'RN', 'LastName': 'Price', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory 0811, Australia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.'}]",Bulletin of the World Health Organization,['10.2471/BLT.18.226688']
193,32179067,"Emerging From the Haze: A Multicenter, Controlled Pilot Study of a Multidimensional, Psychoeducation-Based Cognitive Rehabilitation Intervention for Breast Cancer Survivors Delivered With Telehealth Conferencing.","OBJECTIVE


To quantify the effect of a psychoeducation-based cognitive rehabilitation intervention on breast cancer survivors' self-report of cognitive function and investigate the feasibility of accrual, adherence, and multisite program delivery using secure telehealth conferencing.
DESIGN


Prospective, nonblinded, wait-list controlled pilot study.
SETTING


Nonprofit academic medical center and university medical center with associated community practice affiliates.
PARTICIPANTS


Adult female survivors of stage I-III breast cancer reporting cognitive complaints 2 months to 5 years after chemotherapy (N=61). Ongoing endocrine and/or anti-HER-2 therapy was allowed. Patients were excluded for history of other conditions involving impaired cognitive function. Combination referred and volunteered sample. In total, 107 women were screened, 61 consented, and 52 analyzed. No attrition due to adverse events. Group allocation was based on consent timing and next scheduled cohort to minimize wait time for wait-list controls.
INTERVENTION


Psychoeducation-based cognitive rehabilitation intervention delivered in a group setting during 6 weekly 2.5-hour classes. Included presentation, class exercises, discussion, and homework exercises. Provided in-person and virtually by Health Insurance Portability and Accountability Act compliant and encrypted telehealth conferencing.
MAIN OUTCOME MEASURES


Primary: self-report of perceived cognitive function (PCF) was compared between the intervention group (n=27) and wait-list controls (n=28) with the Functional Assessment of Cancer Therapy-Cognition perceived cognitive impairment subscale. Secondary: feasibility for multisite delivery via teleconferencing was measured by total accrual, percent adherence to 4 of the 6 weeks of content, and participant satisfaction ratings.
RESULTS


The intervention group demonstrated improvement in PCF both at the conclusion of the intervention and 1 month later (P<.01). Within-group improvement in PCF was maintained at 6 and 12 months (P<.01).
CONCLUSION


These study results provide further preliminary evidence of the efficacy of psychoeducation-based cognitive rehabilitation as an intervention for decreased PCF in breast cancer survivors with cognitive complaints after chemotherapy. Feasibility for accrual, adherence, and participant satisfaction with secure telehealth conferencing was demonstrated. These positive pilot study results will inform future work.",2020,"Within-group improvement in PCF was maintained at 6- and 12-months (p<0.01).
","['Non-profit academic medical center and university medical center with associated community practice affiliates', 'breast cancer survivors', 'breast cancer survivors with cognitive complaints following chemotherapy', '107 women screened, 61 consented, 52 analyzed', 'Adult female survivors of stage I-III breast cancer reporting cognitive complaints 2-months-5-years after chemotherapy']","['Primary: Self-report of perceived cognitive function (PCF', 'psycho-education-based cognitive rehabilitation', 'psycho-education-based cognitive rehabilitation intervention', 'Psycho-education-based cognitive rehabilitation intervention', 'multi-dimensional, psycho-education-based cognitive rehabilitation intervention', 'telehealth conferencing']","['PCF', 'Cancer Therapy-Cognition Perceived Cognitive Impairment Subscale', 'Included presentation, class exercises, discussion, and homework exercises']","[{'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}]",107.0,0.0283218,"Within-group improvement in PCF was maintained at 6- and 12-months (p<0.01).
","[{'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Myers', 'Affiliation': 'University of Kansas School of Nursing, Kansas City, KS.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Cook-Wiens', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Baynes', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Mi-Yeoung', 'Initials': 'MY', 'LastName': 'Jo', 'Affiliation': 'Independent Practice, Sherman Oaks, CA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Krigel', 'Affiliation': 'Midwest Cancer Alliance at the University of Kansas Medical Center, Westwood, KS.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Klemp', 'Affiliation': 'University of Kansas Cancer Center, Westwood, KS.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Asher', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, CA. Electronic address: arash.asher@cshs.org.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.01.021']
194,31371434,Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.,"OBJECTIVE


To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth.
DESIGN


Parallel group randomised (1:1) trial.
SETTING


Eight UK tertiary maternity units.
PARTICIPANTS


Two hundred and seventy-six babies born to 261 women expected to have a live birth before 32 +0  weeks' gestation.
INTERVENTIONS


Deferred cord clamping (≥2 min) and immediate neonatal care with cord intact or immediate (≤20 s) clamping and immediate neonatal care after clamping.
MAIN OUTCOME MEASURE


Composite of death or adverse neurodevelopmental outcome at 2 years corrected age.
RESULTS


Six babies born after 35 +6  weeks were excluded. At 2 years corrected age, outcome data were not available for a further 52 children, leaving 218 for analysis (115 deferred clamping, 103 immediate clamping). Overall, 24/115 (21%) children allocated deferred clamping died or had an adverse neurodevelopmental outcome compared with 35/103 (34%) allocated immediate clamping; risk ratio (RR) 0.61 (95% CI 0.39 to 0.96); risk difference (RD) -13% (95% CI -25% to -1%). Multiple imputation for missing data gave an RR 0.69 (95% CI 0.44 to 1.09) and RD -9% (95% CI -21% to 2%).
CONCLUSIONS


Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature. Confirmation in larger studies is needed to determine the real benefits and harms.
TRIAL REGISTRATION NUMBER


ISRCTN21456601.",2020,Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature.,"['Six babies born after 35 +6  weeks were excluded', 'Eight UK tertiary maternity units', 'at very preterm birth', ""Two hundred and seventy-six babies born to 261 women expected to have a live birth before 32 +0  weeks' gestation"", 'children born very premature', '2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth']","['Deferred cord clamping (≥2\u2009min) and immediate neonatal care with cord intact or immediate (≤20\u2009s) clamping and immediate neonatal care after clamping', 'cord clamping', 'Deferred clamping and immediate neonatal care with cord intact']","['Composite of death or adverse neurodevelopmental outcome at 2 years corrected age', 'risk of death or adverse neurodevelopmental outcome', 'adverse neurodevelopmental outcome']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0565824', 'cui_str': 'Born very premature (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",261.0,0.315371,Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature.,"[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Armstrong-Buisseret', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Powers', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Dorling', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bradshaw', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Mitchell', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lelia', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-316912']
195,31336055,Computerized Speechreading Training for Deaf Children: A Randomized Controlled Trial.,"Purpose We developed and evaluated in a randomized controlled trial a computerized speechreading training program to determine (a) whether it is possible to train speechreading in deaf children and (b) whether speechreading training results in improvements in phonological and reading skills. Previous studies indicate a relationship between speechreading and reading skill and further suggest this relationship may be mediated by improved phonological representations. This is important since many deaf children find learning to read to be very challenging. Method Sixty-six deaf 5- to 7-year-olds were randomized into speechreading and maths training arms. Each training program was composed of a 10-min sessions a day, 4 days a week for 12 weeks. Children were assessed on a battery of language and literacy measures before training, immediately after training, and 3 months and 11 months after training. Results We found no significant benefits for participants who completed the speechreading training, compared to those who completed the maths training, on the speechreading primary outcome measure. However, significantly greater gains were observed in the speechreading training group on one of the secondary measures of speechreading. There was also some evidence of beneficial effects of the speechreading training on phonological representations; however, these effects were weaker. No benefits were seen to word reading. Conclusions Speechreading skill is trainable in deaf children. However, to support early reading, training may need to be longer or embedded in a broader literacy program. Nevertheless, a training tool that can improve speechreading is likely to be of great interest to professionals working with deaf children. Supplemental Material https://doi.org/10.23641/asha.8856356.",2019,"We found no significant benefits for participants who completed the speechreading training, compared to those who completed the maths training, on the speechreading primary outcome measure.","['Method Sixty-six deaf 5- to 7-year-olds', 'Deaf Children']","['Computerized Speechreading Training', 'Supplemental Material https://doi.org/10.23641/asha.8856356']","['phonological and reading skills', 'phonological representations']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023844', 'cui_str': 'Lip Reading'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",[],,0.030582,"We found no significant benefits for participants who completed the speechreading training, compared to those who completed the maths training, on the speechreading primary outcome measure.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pimperton', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Kyle', 'Affiliation': 'Division of Language and Communication Science, City University of London, United Kingdom.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Department of Education, University of Oxford, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, United Kingdom.'}, {'ForeName': 'Indie', 'Initials': 'I', 'LastName': 'Beedie', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, United Kingdom.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Ralph-Lewis', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Worster', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rees', 'Affiliation': 'Department of Language and Cognition, University College London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Donlan', 'Affiliation': 'Department of Language and Cognition, University College London, United Kingdom.'}, {'ForeName': 'Mairéad', 'Initials': 'M', 'LastName': 'MacSweeney', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, United Kingdom.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-H-19-0073']
196,31339808,The Effectiveness of Classroom Vocabulary Intervention for Adolescents With Language Disorder.,"Purpose Phonological-semantic intervention has been shown to be effective in enhancing the vocabulary skills of children with language disorder in small-group or individual settings. Less is known about vocabulary interventions for adolescents with language disorder in whole-class models of delivery. The current study investigated the effectiveness of phonological-semantic vocabulary intervention for adolescents with language disorder, delivered by secondary school teachers within science lessons. Method Seventy-eight adolescents with language disorder, aged 11-14 years, were taught science curriculum words by teachers in class, under 2 conditions: (a) 10 words taught through usual teaching practice and (b) 10 matched words taught using an experimental intervention known as Word Discovery, which embedded phonological-semantic activities into the teaching of the syllabus. Ten similar control words received no intervention. Word knowledge was assessed pre-intervention, postintervention, and follow-up. Results At pre-intervention, measures of depth of word knowledge and expressive word use did not differ between usual teaching practice and experimental words. At postintervention, depth of knowledge of experimental words was significantly greater than that of usual teaching practice words. This significant advantage was not maintained at follow-up, although depth of knowledge for experimental words remained significantly higher at follow-up than at pre-intervention. At postintervention, expressive use of experimental words was significantly greater than that of usual teaching practice words, and this significant difference was maintained at follow-up. There was no change in students' depth of knowledge or expressive use of no-intervention words over time, confirming that the findings were not due to maturity or practice effects. Conclusion The experimental intervention was more effective than usual teaching practice in increasing the word knowledge of participants. Clinical and teaching implications include the importance of intervening during the adolescent years, with classroom vocabulary intervention being a viable option for collaborative teacher and speech and language therapy/pathology practice.",2019,"pre-intervention, measures of depth of word knowledge and expressive word use did not differ between usual teaching practice and experimental words.","['adolescents with language disorder', 'children with language disorder in small-group or individual settings', 'Method Seventy-eight adolescents with language disorder, aged 11-14 years', 'Adolescents With Language Disorder', 'adolescents with language disorder, delivered by secondary school teachers within science lessons']","['Phonological-semantic intervention', 'phonological-semantic vocabulary intervention', 'taught science curriculum words by teachers in class, under 2 conditions: (a) 10 words taught through usual teaching practice and (b) 10 matched words taught using an experimental intervention known as Word Discovery, which embedded phonological-semantic activities into the teaching of the syllabus', 'Classroom Vocabulary Intervention']","['depth of knowledge of experimental words', 'expressive use of experimental words', 'depth of knowledge for experimental words', ""students' depth of knowledge or expressive use"", 'Word knowledge', 'depth of word knowledge and expressive word use']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0023015', 'cui_str': 'Language Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0401908', 'cui_str': 'Secondary school teacher (occupation)'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0157749,"pre-intervention, measures of depth of word knowledge and expressive word use did not differ between usual teaching practice and experimental words.","[{'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Lowe', 'Affiliation': 'Division of Language and Communication Science, School of Health Sciences, City, University of London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Henry', 'Affiliation': 'Division of Language and Communication Science, School of Health Sciences, City, University of London, United Kingdom.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Joffe', 'Affiliation': 'Division of Language and Communication Science, School of Health Sciences, City, University of London, United Kingdom.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-18-0337']
197,30647190,MRI and Dose Selection in a Phase II Trial of Baricitinib with Conventional Synthetic Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis.,"OBJECTIVE


Magnetic resonance imaging (MRI) was used in a phase IIb study of baricitinib in patients with RA to support dose selection for the phase III program.
METHODS


Three hundred one patients with active RA who were taking stable methotrexate were randomized 2:1:1:1:1 to placebo or once-daily baricitinib (1, 2, 4, or 8 mg) for up to 24 weeks. One hundred fifty-four patients with definitive radiographic erosion had MRI of the hand/wrist at baseline and at weeks 12 and 24. Two expert radiologists, blinded to treatment and visit order, scored images for synovitis, osteitis, bone erosion, and cartilage loss. Combined inflammation (osteitis + 3× synovitis score) and total joint damage (erosion + 2.5× cartilage loss score) scores were calculated. Treatment groups were compared using ANCOVA adjusting for baseline scores.
RESULTS


Mean changes from baseline to Week 12 for synovitis were -0.10, -1.50, and -1.60 for patients treated with placebo, baricitinib 4 mg, and baricitinib 8 mg, respectively (p = 0.003 vs placebo for baricitinib 4 and 8 mg). Mean changes for osteitis were 0.00, -3.20, and -2.10 (p = 0.001 vs placebo for baricitinib 4 mg and p = 0.037 for 8 mg), respectively. Mean changes for bone erosion were 0.90, 0.10, and 0.40 (p = 0.089 for 4 mg and p = 0.275 for 8 mg), respectively, in these treatment groups.
CONCLUSION


MRI findings in this subgroup of patients suggest suppression of synovitis, osteitis, and combined inflammation by baricitinib 4 and 8 mg. This corroborates previously demonstrated clinical efficacy of baricitinib and increases confidence that baricitinib 4 mg could reduce the radiographic progression in phase III studies. [Clinical trial registration number (www.ClinicalTrials.gov): NCT01185353].",2019,Combined inflammation (osteitis + 3× synovitis score) and total joint damage (erosion + 2.5× cartilage loss score) scores were calculated.,"['One hundred fifty-four patients with definitive radiographic erosion had MRI of the hand/wrist at baseline and at weeks 12 and 24', 'Rheumatoid Arthritis', 'Three hundred one patients with active RA who were taking stable', 'patients with RA to support dose selection for the phase III program']","['Magnetic resonance imaging (MRI', 'methotrexate', 'placebo', 'placebo or once-daily baricitinib']","['Mean changes for bone erosion', 'Mean changes for osteitis', 'Combined inflammation (osteitis + 3× synovitis score) and total joint damage (erosion + 2.5× cartilage loss score) scores', 'radiographic progression']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C0029400', 'cui_str': 'Bone Inflammation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",154.0,0.103565,Combined inflammation (osteitis + 3× synovitis score) and total joint damage (erosion + 2.5× cartilage loss score) scores were calculated.,"[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peterfy', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada. charles.peterfy@spiresciences.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'DiCarlo', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Keystone', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Doug E', 'Initials': 'DE', 'LastName': 'Schlichting', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Beattie', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Luchi', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Macias', 'Affiliation': 'From Spire Sciences Inc., Boca Raton, Florida; Division of Immunology and Rheumatology, Stanford University, Stanford, California; Eli Lilly and Co., Indianapolis, Indiana; Incyte Corporation, Wilmington, Delaware, USA; The Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; Botnar Research Centre, University of Oxford, Oxford, UK; Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of rheumatology,['10.3899/jrheum.171469']
198,31056465,Impact of 4 Components of Instructional Design Video on Medical Student Medical Decision Making During the Inpatient Rounding Experience.,"INTRODUCTION


The Four Components of Instructional Design (4C-ID) Model has been used to teach Medical Decision Making (MDM), a core competency recognized by the Liaison Committee for Medical Education. 4 Components of Instructional Design (4C-ID) has been applied in general medical education, but not the inpatient clerkship setting. A 4C-ID video for inpatient rounding, like postpartum rounding in Ob/Gyn, could help improve MDM on busy services.
METHODS


Students in the third year Ob/Gyn clerkship were randomized by clerkship group to receive a 20-minute postpartum rounding video, based on 4C-ID principles, or usual teaching. MDM and knowledge were assessed pre-/postintervention with the Diagnostic Thinking Inventory and a case-based evaluation. Satisfaction was assessed with Likert style questions.
RESULTS


Seventy-eight students were randomized (36 control, 42 intervention). Both groups had equal baseline measures of MDM and knowledge, and similar postclerkship MDM. The intervention group demonstrated higher knowledge postclerkship (17.1, 22.6 p < 0.001). Students in the intervention felt prepared by the video, and would recommend it. Students in the control group reported higher satisfaction with their postpartum rounding experience (3.9, 3.5 p = 0.04).
DISCUSSION


Videos are easy to incorporate teaching platforms for medical students, however, the 4C-ID based video in this study did not increase student MDM. In addition, educators should use caution when integrating video into coursework as use of video may lead to decreased student satisfaction as it did in this study.",2019,"The intervention group demonstrated higher knowledge postclerkship (17.1, 22.6 p < 0.001).","['Students in the third year Ob/Gyn clerkship', 'Seventy-eight students']","['clerkship group to receive a 20-minute postpartum rounding video, based on 4C-ID principles, or usual teaching', 'Instructional Design Video', 'Instructional Design']","['student satisfaction', 'Satisfaction', 'higher knowledge postclerkship', 'MDM and knowledge, and similar postclerkship MDM', 'higher satisfaction with their postpartum rounding experience']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",78.0,0.0225809,"The intervention group demonstrated higher knowledge postclerkship (17.1, 22.6 p < 0.001).","[{'ForeName': 'Alex Friedman', 'Initials': 'AF', 'LastName': 'Peahl', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Institute for Healthcare Policy and Innovation, National Clinical Scholar, Ann Arbor, Michigan. Electronic address: alexfrie@med.umich.edu.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Tarr', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Phinnara', 'Initials': 'P', 'LastName': 'Has', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University/Women and Infants Hospital, Providence, Rhode Island.'}, {'ForeName': 'B Star', 'Initials': 'BS', 'LastName': 'Hampton', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University/Women and Infants Hospital, Providence, Rhode Island.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.04.004']
199,32216084,Population and Noncompartmental Pharmacokinetics of Sodium Oxybate Support Weight-Based Dosing in Children and Adolescents With Narcolepsy With Cataplexy.,"The pharmacokinetics (PKs) of sodium oxybate (SXB) was evaluated in a subset of participants from a study of SXB treatment in children (aged 7-11 years; n = 11) and adolescents (aged 12-17 years; n = 18) with narcolepsy with cataplexy. PK evaluation was conducted over 2 nights during the period when participants received a stable nightly SXB dose. The SXB dose on night 1 was half of night 2 and was administered in two equally divided doses: dose 1 was administered > 2 hours after the evening meal, and dose 2 was administered ≥ 4 hours after dose 1. Noncompartmental PK analysis demonstrated higher plasma concentrations post-dose 2 vs. post-dose 1, higher than dose-proportional increases in area under the concentration-time curve from 0 to 4 hours (AUC 0-4h  ) after dose 1, indicating nonlinear clearance, and better correlation between exposure and mg/kg than exposure and gram dose. To confirm the noncompartmental findings, identify factors affecting SXB PK, and compare with prior results in adults, a population PK (PopPK) model was established combining PK data from the current study with prior data from adults (132 healthy volunteers and 13 with narcolepsy). A two-compartment PopPK model with first-order absorption and nonlinear clearance from the central compartment described the data well. PopPK identified weight as the main intrinsic factor and food as the main extrinsic factor affecting SXB PK, and predicts similar PK profiles on a mg/kg basis across ages. These results, along with previously reported efficacy and safety outcomes, support weight-based SXB dose initiation in pediatric patients.",2020,"Noncompartmental PK analysis demonstrated higher plasma concentrations post-dose 2 versus post-dose 1, higher than dose-proportional increases in area under the concentration-time curve from 0 to 4 hours (AUC 0-4h  ) after dose 1, indicating nonlinear clearance, and better correlation between exposure and mg/kg than exposure and gram dose.","['subset of participants from a study of SXB treatment in children (aged 7-11 years; n=11) and adolescents (aged 12-17 years; n=18) with narcolepsy with cataplexy', '132 healthy volunteers, 13 with narcolepsy', 'Children and Adolescents With Narcolepsy With Cataplexy']","['Sodium Oxybate Support Weight-Based Dosing', 'sodium oxybate (SXB']","['efficacy and safety outcomes, support weight-based SXB dose initiation', 'plasma concentrations']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0007384', 'cui_str': 'Henneberg Syndrome'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037537', 'cui_str': 'Sodium Oxybate'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",132.0,0.0224674,"Noncompartmental PK analysis demonstrated higher plasma concentrations post-dose 2 versus post-dose 1, higher than dose-proportional increases in area under the concentration-time curve from 0 to 4 hours (AUC 0-4h  ) after dose 1, indicating nonlinear clearance, and better correlation between exposure and mg/kg than exposure and gram dose.","[{'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Rosen', 'Affiliation': ""Division of Pediatric Pulmonology and Sleep Medicine, Rainbow Babies & Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Ruoff', 'Affiliation': 'Stanford University Sleep Medicine Center, Redwood City, California, USA.'}, {'ForeName': 'Leslie H', 'Initials': 'LH', 'LastName': 'Boyce', 'Affiliation': 'Raleigh Neurology Associates, Raleigh, North Carolina, USA.'}, {'ForeName': 'Rupa', 'Initials': 'R', 'LastName': 'Parvataneni', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zomorodi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Brantley', 'Affiliation': 'Nuventra Pharma Sciences, Durham, North Carolina, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sale', 'Affiliation': 'Nuventra Pharma Sciences, Durham, North Carolina, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.'}]",Clinical and translational science,['10.1111/cts.12780']
200,30910500,Effectiveness of an In-Service Education Program to Improve Patient Safety Directed at Surgical Residents: A Randomized Controlled Trial.,"BACKGROUND


Patient safety is a critical issue in healthcare services particularly in surgical units and operation rooms because of the high prevalence and risk of medical errors in such settings. This study was conducted to determine whether a 1-day educational intervention can change the attitude and behavior of surgical residents regarding patient safety.
METHODS


A total of 90 surgical residents were recruited from 6 university hospitals located in Tehran and Qazvin, Iran, and were randomized to either the intervention or a control group. Those in the intervention group participated in a 1-day workshop on patient safety, whereas the control group received no intervention. Both groups were followed for 3 months after the intervention was completed. The Safety Attitude Questionnaire and Oxford Non-Technical Skills scale were administered at 3 points in time (baseline, 1 month after the intervention, and 3 month later). The data were analyzed using repeated measures analysis of variance.
RESULTS


Total score on the Safety Attitude Questionnaire improved from 54.5 (SD = 14.4) at baseline to 58.3 (SD = 13.8) 3 months after the intervention in the intervention group; all dimensions, with the exception of working condition, showed significant changes. In addition, the Oxford Non-Technical Skills scale - as assessed by attending surgeons - improved significantly in all domains (p < 0.05). More than 60% of participants in the intervention group scored in the positive range for items assessing safety and teamwork climate.
CONCLUSIONS


A 1-day interactive educational workshop may be effective in changing the attitude and practice of surgical residents regarding patient safety. Further assessment of this intervention in other healthcare settings involving health professionals from various specialties and use of an objective measure such as number of reported medical errors are needed to corroborate these findings.",2019,"More than 60% of participants in the intervention group scored in the positive range for items assessing safety and teamwork climate.
","['90 surgical residents were recruited from 6 university hospitals located in Tehran and Qazvin, Iran', 'at Surgical Residents']","['1-day workshop', '1-day interactive educational workshop', '1-day educational intervention', 'Service Education Program', 'control group received no intervention']","['positive range for items assessing safety and teamwork climate', 'Safety Attitude Questionnaire', 'Safety Attitude Questionnaire and Oxford Non-Technical Skills scale', 'Patient Safety Directed']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222045'}, {'cui': 'C1113679'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]",90.0,0.0427621,"More than 60% of participants in the intervention group scored in the positive range for items assessing safety and teamwork climate.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ameryoun', 'Affiliation': 'Health Management Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Social Determinants of Health Research Center (SDH), Qazvin University of Medical Sciences, Qazvin, Iran; Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden. Electronic address: Pakpour_Amir@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Nikoobakht', 'Affiliation': 'Department of Neurosurgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Saffari', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran; Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: m.saffari@bmsu.ac.ir.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Keisha-Gaye N', 'Initials': 'KN', 'LastName': ""O'Garo"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Harold G', 'Initials': 'HG', 'LastName': 'Koenig', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina; King Abdulaziz University, Jeddah, Saudi Arabia; Ningxia Medical University, Yinchuan, China.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.03.002']
201,28263370,Fixed-dose combination therapy for the prevention of atherosclerotic cardiovascular diseases.,"BACKGROUND


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


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


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


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


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


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


The effects of fixed-dose combination therapy on all-cause mortality or ASCVD events are uncertain. A limited number of trials reported these outcomes, and the included trials were primarily designed to observe changes in ASCVD risk factor levels rather than clinical events, which may partially explain the observed differences in risk factors that were not translated into differences in clinical outcomes among the included trials. Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo, active comparator, or usual care but may be associated with improved adherence to a multidrug regimen. Ongoing, longer-term trials of fixed-dose combination therapy will help demonstrate whether short-term changes in risk factors might be maintained and lead to expected differences in clinical events based on these changes.",2017,"Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo, active comparator, or usual care but may be associated with improved adherence to a multidrug regimen.","['adults 18 years old or older, with no restrictions on presence or absence of pre-existing ASCVD', '7047 participants and four additional trials (n = 2012 participants; mean age range 62 to 63 years; 30% to 37% women']","['Fixed-dose combination therapy', 'fixed-dose combination therapy including at least one blood pressure-lowering and one lipid-lowering component versus usual care, placebo, or an active drug comparator', 'fixed-dose combination (FDC) therapy']","['total and LDL cholesterol', 'blood pressure and lipids', 'Adverse events', 'adherence to a multidrug strategy', 'cause mortality, fatal and non-fatal ASCVD events, and adverse events', 'calculated risk ratios (RR', 'adverse events', 'fatal and non-fatal ASCVD events', 'systolic blood pressure', 'blood pressure, lipids, adherence, discontinuation rates, health-related quality of life, and costs', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",4517.0,0.564458,"Fixed-dose combination therapy is associated with modest increases in adverse events compared with placebo, active comparator, or usual care but may be associated with improved adherence to a multidrug regimen.","[{'ForeName': 'Ehete', 'Initials': 'E', 'LastName': 'Bahiru', 'Affiliation': 'Internal Medicine; Division of Cardiology, Northwestern University, 201 E. Huron St. Galter 19-100, Chicago, Illinois, USA, 60611.'}, {'ForeName': 'Angharad N', 'Initials': 'AN', 'LastName': 'de Cates', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Matthew Rb', 'Initials': 'MR', 'LastName': 'Farr', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Morag C', 'Initials': 'MC', 'LastName': 'Jarvis', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Palla', 'Affiliation': 'Department of Medicine, Wayne State University, 540 E Canfield St, Detroit, Michigan, USA, 48201.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rees', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.'}, {'ForeName': 'Shah', 'Initials': 'S', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, Keppel Street, London, UK, WC1E 7HT.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'Departments of Preventive Medicine and Medicine (Cardiology), Northwestern University Feinberg School of Medicine, 680 N. Lake Shore Drive, Suite 1400, Chicago, IL, USA, 60611.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009868.pub3']
202,30937920,Association of Teacher-Level Factors With Implementation of Classroom-Based Physical Activity Breaks.,"BACKGROUND


Classroom-based physical activity (CBPA) breaks are a common strategy to increase elementary school children's physical activity (PA) levels. There is limited research examining how teacher-level factors impact teacher implementation of CBPA breaks. In this study, we assessed the relationship of teacher-level factors with teacher use of a CBPA resource.
METHODS


We randomized 6 elementary schools in rural Oregon into control (N = 3) or intervention (N = 3) conditions. Each teacher at intervention schools received the CBPA resource. Teachers at control schools received 1 CBPA-Toolkit per grade level to share, and received no training. We surveyed teachers on their use of the toolkit, implementation support and self-efficacy, and value for PA. Logistic regression was used to examine the odds of toolkit use by teacher-level factors.
RESULTS


Among survey respondents (N = 83), 57% were self-identified toolkit users and 48% attended a training. Training participation and teacher implementation self-efficacy were associated with greater odds of using the toolkit (odds ratio, OR = 7.76 [95% confidence interval, CI = 1.39-43.19] and OR = 5.54 [95% CI = 1.24-23.87], respectively).
CONCLUSION


CBPA tools supported with training aimed at developing teachers' implementation self-efficacy increased the likelihood of teachers employing CBPA tools.",2019,"Training participation and teacher implementation self-efficacy were associated with greater odds of using the toolkit (odds ratio, OR = 7.76 [95% confidence interval, CI = 1.39-43.19] and OR = 5.54 [95% CI = 1.24-23.87], respectively).
","['survey respondents', ""elementary school children's"", '6 elementary schools in rural Oregon into control (N\u2009=\u20093) or intervention (N\u2009=\u20093) conditions']",['Classroom-based physical activity (CBPA) breaks'],['physical activity (PA) levels'],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",6.0,0.0339934,"Training participation and teacher implementation self-efficacy were associated with greater odds of using the toolkit (odds ratio, OR = 7.76 [95% confidence interval, CI = 1.39-43.19] and OR = 5.54 [95% CI = 1.24-23.87], respectively).
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Abi Nader', 'Affiliation': 'Université de Moncton, Pavillon J.-Raymond-Frenette, 100 rue des Aboiteaux, Moncton, NB E1A 3E9, Canada.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Hilberg', 'Affiliation': 'Hallie E. Ford Center, Oregon State University, Corvallis, OR 97331.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Schuna', 'Affiliation': 'Oregon State University, 118H Milam Hall, Corvallis, OR 97331.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'John', 'Affiliation': 'Oregon State University, 105F Ballard Hall, Corvallis, OR 97331.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Gunter', 'Affiliation': 'Oregon State University, 247 Hallie E. Ford Center, Corvallis, OR 97331.'}]",The Journal of school health,['10.1111/josh.12754']
203,31348732,Clinical Outcomes Following Language-Specific Attention Treatment Versus Direct Attention Training for Aphasia: A Comparative Effectiveness Study.,"Purpose This study was conducted to examine the comparative effectiveness of 2 different approaches, 1 domain-specific and the other domain-general, to language and attention rehabilitation in participants with stroke-induced aphasia. The domain-specific treatment consisted of language-specific attention treatment (L-SAT), and the domain-general treatment consisted of direct attention training (DAT) using the computerized exercises included in Attention Process Training-3 (Sohlberg & Mateer, 2010). Method Four individuals with mild-moderate aphasia participated in this study. A randomized controlled cross-over single-subject design was used to assess the effectiveness of the 2 treatments administered in this study. Treatment outcomes were evaluated in terms of participants' task performance for each program, standardized language and attention measures, tests of functional abilities, and patient-reported outcomes. Results Visual comparisons demonstrated linear improvements following L-SAT and variable patterns following DAT. Omnibus effect sizes were statistically significant for 9 of the 13 L-SAT tasks. The weighted standardized effect sizes for posttreatment changes following L-SAT ranged from small to large, with the exception of 1 task. The average group gain following DAT was 5%. The Western Aphasia Battery-Revised Aphasia Quotients (Kertesz, 2007) demonstrated reliable improvements for 3 of the 4 participants following L-SAT, whereas only 1 of the participants improved reliably following DAT. The margins of improvements in functional language were substantially larger following L-SAT than DAT. Performance on the Test of Everyday Attention improved significantly for 2 participants following L-SAT and for 1 participant following DAT on selected Test of Everyday Attention (Robertson, Ward, Ridgeway, & Nimmo-Smith, 1994) subtests. Patient-reported outcomes for communication and attention following treatment favored L-SAT compared to DAT. Conclusions The results support the view that attention is allocated in ways that are particular to specific tasks rather than as a general resource that is allocated equivalently to all processing tasks. Domain-specific treatment for language deficits due to attentional impairment appears to be a suitable, if not preferable, approach for aphasia rehabilitation. Supplemental Material https://doi.org/10.23641/asha.8986427.",2019,"Performance on the Test of Everyday Attention improved significantly for 2 participants following L-SAT and for 1 participant following DAT on selected Test of Everyday Attention (Robertson, Ward, Ridgeway, & Nimmo-Smith, 1994) subtests.","['participants with stroke-induced aphasia', 'Aphasia', 'Method Four individuals with mild-moderate aphasia']","['language-specific attention treatment (L-SAT), and the domain-general treatment consisted of direct attention training (DAT) using the computerized exercises included in Attention Process Training-3', 'Language-Specific Attention Treatment Versus Direct Attention Training', '2 different approaches, 1 domain-specific and the other domain-general, to language and attention rehabilitation', 'Supplemental Material https://doi.org/10.23641/asha.8986427']","['Everyday Attention', ""participants' task performance for each program, standardized language and attention measures, tests of functional abilities, and patient-reported outcomes"", 'Western Aphasia Battery-Revised Aphasia Quotients', 'functional language']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0199174', 'cui_str': 'General treatment'}, {'cui': 'C0566193', 'cui_str': 'Does direct attention (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C4273775', 'cui_str': 'WAB-R - Western Aphasia Battery-Revised'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}]",,0.110409,"Performance on the Test of Everyday Attention improved significantly for 2 participants following L-SAT and for 1 participant following DAT on selected Test of Everyday Attention (Robertson, Ward, Ridgeway, & Nimmo-Smith, 1994) subtests.","[{'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Peach', 'Affiliation': 'Department of Communication Disorders and Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Beck', 'Affiliation': 'Department of Communication Disorders and Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Gorman', 'Affiliation': 'Department of Communication Disorders and Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fisher', 'Affiliation': 'Department of Communication Disorders and Sciences, Rush University Medical Center, Chicago, IL.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-18-0504']
204,31032979,A Social Gradient in the Effects of the Skills for Life Program on Self-Efficacy and Mental Wellbeing of Adolescent Students.,"BACKGROUND


The goal of the current study was to evaluate the effects of the Social Emotional Learning program Skills 4 Life on mental health and its risk factors self-esteem, self-efficacy, and social interaction skills in students of secondary schools.
METHODS


A cluster randomized controlled study was conducted, including 38 schools (66 classes; grades 7 to 9) for secondary education, with a 1 year and 20 months follow-up (teachers and students reports).
RESULTS


The intervention was effective in improving self-efficacy, depressive symptoms, and teacher-reported psychological problem behavior, all after 20 months. Stratified analyses showed effects in mainly lower educational level students.
CONCLUSION


The Skills 4 Life curriculum is effective in improving the mental health and self-efficacy among adolescents, especially for adolescents from lower educational level, a group that is most prone to ill mental health.",2019,"The intervention was effective in improving self-efficacy, depressive symptoms, and teacher-reported psychological problem behavior, all after 20 months.","['Adolescent Students', '38 schools (66 classes; grades 7 to 9) for secondary education, with a 1 year and 20\u2009months follow-up (teachers and students reports', 'students of secondary schools']",['Social Emotional Learning program Skills 4 Life'],"['mental health and self-efficacy', 'mental health and its risk factors self-esteem, self-efficacy, and social interaction skills', 'self-efficacy, depressive symptoms, and teacher-reported psychological problem behavior', 'Self-Efficacy and Mental Wellbeing']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}]","[{'cui': 'C0582589', 'cui_str': 'Emotional learning (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0518605', 'cui_str': 'Social interaction skills'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]",,0.0331837,"The intervention was effective in improving self-efficacy, depressive symptoms, and teacher-reported psychological problem behavior, all after 20 months.","[{'ForeName': 'Fieke D', 'Initials': 'FD', 'LastName': 'Pannebakker', 'Affiliation': 'Department of Child Health, Netherlands Organisation for Applied Scientific Research (TNO), P.O. Box 3005, 2301 DA Leiden, The Netherlands.'}, {'ForeName': 'Lenneke', 'Initials': 'L', 'LastName': 'van Genugten', 'Affiliation': 'Department of Child Health, Netherlands Organisation for Applied Scientific Research (TNO), P.O. Box 3005, 2301 DA Leiden, The Netherlands.'}, {'ForeName': 'René F W', 'Initials': 'RFW', 'LastName': 'Diekstra', 'Affiliation': 'University of Applied Sciences, The Hague Johanna Westerdijkplein 75, 2521 EN Den Haag, The Netherlands.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Gravesteijn', 'Affiliation': 'Leiden University of Applied Sciences, Zernikedreef 11, 2333 CK Leiden, The Netherlands.'}, {'ForeName': 'Minne', 'Initials': 'M', 'LastName': 'Fekkes', 'Affiliation': 'Department of Child Health, Netherlands Organisation for Applied Scientific Research (TNO), P.O. Box 3005, 2301 DA Leiden, The Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kuiper', 'Affiliation': 'Utrecht University, Social Sciences, Methodology & Statistics, Padualaan 14, 3584 CH Utrecht, The Netherlands.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Kocken', 'Affiliation': 'Department of Child Health, Netherlands Organisation for Applied Scientific Research (TNO), P.O. Box 3005, 2301 DA Leiden, The Netherlands.'}]",The Journal of school health,['10.1111/josh.12779']
205,31257605,Breakfast Is Brain Food? The Effect on Grade Point Average of a Rural Group Randomized Program to Promote School Breakfast.,"BACKGROUND


Adolescents frequently miss breakfast which may impact cognitive, academic, and health outcomes. This analysis describes the effect of a trial to assess school level changes to increase breakfast consumption on grade point average (GPA).
METHODS


Sixteen rural Minnesota high schools were randomized to a policy and environmental change intervention or delayed intervention (control) group. Baseline screening identified, randomly selected and enrolled 9th and 10th grade students who eat breakfast ≤3 times per school week for assessment. Mean unweighted GPA was provided by 13 schools for 636 students. Student-level and administrative data were used for sociodemographic and free or reduced-price meals (FRPM). Linear mixed models and latent class analysis (LCA) were used to assess change in GPA.
RESULTS


Students were 54% female, 76% white, and 34% received FRPM. Unweighted cumulative GPA mean = 2.82 (0.78) at baseline. There was no significant intervention effect on GPA postintervention or 1-year follow-up. LCA revealed two classes: ""higher"" (N = 495) and ""lower"" (N = 141) resource. There was an intervention effect among low-resource students from baseline to 1-year post only among the control condition (delayed intervention).
CONCLUSIONS


In combination with the full study results, increasing breakfast consumption may have an impact particularly for low resource students.",2019,"There was an intervention effect among low-resource students from baseline to 1-year post only among the control condition (delayed intervention).
","['Sixteen rural Minnesota high schools', 'Students were 54% female, 76% white, and 34% received', 'Baseline screening identified, randomly selected and enrolled 9th and 10th grade students who eat breakfast ≤3 times per school week for assessment']","['FRPM', 'policy and environmental change intervention or delayed intervention (control) group']",['grade point average (GPA'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",16.0,0.0441216,"There was an intervention effect among low-resource students from baseline to 1-year post only among the control condition (delayed intervention).
","[{'ForeName': 'Mary O', 'Initials': 'MO', 'LastName': 'Hearst', 'Affiliation': 'St. Catherine University - Henrietta Schmoll School of Health, 2004 Randolph Ave, St. Paul, MN 55105.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Jimbo-Llapa', 'Affiliation': 'St. Catherine University - Henrietta Schmoll School of Health, 2004 Randolph Ave, St. Paul, MN 55105.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Grannon', 'Affiliation': 'University of Minnesota - Department of Family Medicine and Community Health, Program in Health Disparities Research, 717 Delaware Ave, Minneapolis, MN 55454.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'University of Minnesota - Clinical and Translational Science Institute, 717 Delaware Street S.E., Minneapolis, MN 55414.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Nanney', 'Affiliation': 'University of Minnesota - Department of Family Medicine and Community Health, Program in Health Disparities Research, 717 Delaware Ave, Minneapolis, MN 55454.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Caspi', 'Affiliation': 'University of Minnesota - Department of Family Medicine and Community Health, 717 Delaware St. SE, Minneapolis, MN 55414.'}]",The Journal of school health,['10.1111/josh.12810']
206,31161606,Evaluation of Educational Interventions to Enhance Adolescent Specific Vaccination Coverage.,"BACKGROUND


In this study, we assessed impact of two educational interventions designed to increase coverage of three vaccines recommended during adolescence among Georgia middle and high school students (tetanus diphtheria pertussis [Tdap], meningococcal [MenACWY], and human papillomavirus [HPV] vaccines).
METHODS


We randomized 11 middle and high schools in one school district into one of three arms: (1) control; (2) educational intervention for parents only (P only); and (3) multicomponent educational intervention for parents and adolescents (P + A), which consisted of educational brochures for parents about vaccines recommended during adolescence and a vaccine-focused curriculum delivered to adolescents by science teachers. We obtained vaccination coverage data during intervention years from the state immunization registry.
RESULTS


Odds of receiving at least one vaccine during the study were higher among adolescents in P + A arm compared to control (Odds Ratio [OR]: 1.4; 95% Confidence Interval [CI]: 1.1-2.0). Adolescents in P + A arm had greater odds of receiving at least one vaccine compared with those in P only arm (OR: 1.4; 95% CI: 1.1-1.7).
CONCLUSIONS


A multicomponent educational intervention for adolescents and parents increased adolescent vaccination uptake. Results suggest similar interventions can increase awareness and demand for vaccines among parents and adolescents.",2019,Adolescents in P + A arm had greater odds of receiving at least one vaccine compared with those in P only arm (,"['adolescence among Georgia middle and high school students (tetanus', '11 middle and high schools in one school district into one of three arms: (1', 'parents and adolescents']","['diphtheria pertussis [Tdap', 'multicomponent educational intervention', 'control; (2) educational intervention for parents only (P only); and (3) multicomponent educational intervention for parents and adolescents (P\u2009+\u2009A), which consisted of educational brochures for parents about vaccines recommended during adolescence and a vaccine-focused curriculum delivered to adolescents by science teachers', 'Educational Interventions']","['awareness and demand for vaccines', 'adolescent vaccination uptake']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",11.0,0.0736578,Adolescents in P + A arm had greater odds of receiving at least one vaccine compared with those in P only arm (,"[{'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Underwood', 'Affiliation': 'National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Hwy., NE, MS F-64 (mailing), Atlanta, GA 30341.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Gargano', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, 1462 Clifton Road Room 446, Atlanta, GA 30329.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sales', 'Affiliation': 'Emory University Rollins School of Public Health, 1518 Clifton Road, Atlanta, GA 30322.'}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Vogt', 'Affiliation': 'Centers for Disease Control and Prevention, National Center for Immunizations and Respiratory Diseases, 1600 Clifton Road NE, MS A19, Atlanta, GA 30329.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Seib', 'Affiliation': 'IANPHI, Global Health Institute, Emory University, 1599 Clifton Road Room 6.403, Atlanta, GA 30322.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Hughes', 'Affiliation': 'Emory University School of Medicine, 1462 Clifton Road Room 446, Atlanta, GA 30322.'}]",The Journal of school health,['10.1111/josh.12786']
207,31245850,Head Start Centers Can Influence Healthy Behaviors: Evaluation of a Nutrition and Physical Activity Educational Intervention.,"BACKGROUND


Because healthy habits are established early in life, it is important to teach young children about foods that contribute to a healthy diet. One of the strategies recommended by the 2015-2020 Dietary Guidelines is to implement educational programs in community settings such as child care and preschool settings. Head Start is one such educational child care setting that serves young children ages 3 to 5 years old.
METHODS


A community partnership was established between Jackson County Civic Action Agency and supported by the Mississippi Gulf Coast Youth Health Coalition's Childhood Obesity Initiative. A quasi-experimental nonequivalent 2-group pre/post-test study design was utilized to determine the effectiveness of a 12-week physical activity and nutrition education program delivered in a Head Start setting.
RESULTS


There was a statistically significant improvement in fruit (F = 5.602, df = 1, p = .018) and vegetable (F = 16.061, df = 1, p < .001) recognition scores, and the number of ""tried and liked"" fruits (F = 5.579, df = 1, p = .019) and vegetables (F = 88.559, df = 1, p < .001) between children in the control group (n = 86) and intervention group (n = 303) when controlling for scores at baseline.
CONCLUSION


Utilizing the Head Start program as a setting for health education program delivery is one available strategy to combat childhood obesity on a community level.",2019,"p < .001) recognition scores, and the number of ""tried and liked"" fruits (F = 5.579, df = 1, p = .019) and vegetables (F = 88.559, df = 1, p < .001) between children in the control group (n = 86) and intervention group (n = 303) when controlling for scores at baseline.
CONCLUSION


","['young children ages 3 to 5\xa0years old', ""A community partnership was established between Jackson County Civic Action Agency and supported by the Mississippi Gulf Coast Youth Health Coalition's Childhood Obesity Initiative"", 'Head Start Centers']","['Nutrition and Physical Activity Educational Intervention', 'physical activity and nutrition education program']","['number of ""tried and liked"" fruits']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]",,0.0126591,"p < .001) recognition scores, and the number of ""tried and liked"" fruits (F = 5.579, df = 1, p = .019) and vegetables (F = 88.559, df = 1, p < .001) between children in the control group (n = 86) and intervention group (n = 303) when controlling for scores at baseline.
CONCLUSION


","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Fastring', 'Affiliation': 'University of Southern Mississippi, PO Box 5122, Hattiesburg, MS 39406.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Keel', 'Affiliation': 'Mississippi Gulf Coast Youth Health, Coalition, PO Box 1329, Biloxi, MS 39533.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Colby', 'Affiliation': 'The National Diabetes and Obesity Research Institute, 12500 Village Avenue East, Biloxi, MS 39532.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Conner', 'Affiliation': 'University of Southern Mississippi, PO Box 5122, Hattiesburg, MS 39406.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Hilbert', 'Affiliation': 'University of Southern Mississippi, PO Box 5122, Hattiesburg, MS 39406.'}]",The Journal of school health,['10.1111/josh.12811']
208,32301501,Response to Inhibition of Receptor-Interacting Protein Kinase 1 (RIPK1) in Active Plaque Psoriasis: A Randomized Placebo-Controlled Study.,"Receptor-interacting protein kinase 1 (RIPK1), a regulator of inflammation and cell death, is a potential therapeutic target in immune-mediated inflammatory diseases (IMIDs). The objective of this phase IIa multicenter, randomized, double-blind, placebo-controlled study was to evaluate safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy of GSK2982772, a RIPK1 inhibitor, in plaque-type psoriasis. Psoriasis patients (N = 65) were randomized to 60 mg twice daily (b.i.d.) or three times daily (t.i.d.), or placebo for 84 days. Most adverse events (AEs) were mild with no severe drug-related AEs reported. Plaque Lesion Severity Sum improved with b.i.d. treatment compared with placebo; interpretation of t.i.d. treatment results was complicated by a high placebo response. Reductions in epidermal thickness and infiltration by CD3+ T cells in the epidermis and dermis were observed compared with placebo. Results support the rationale for additional studies on RIPK1 inhibition in IMIDs.",2020,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"['plaque-type psoriasis', 'Psoriasis patients (N=65', 'active plaque psoriasis']","['receptor-interacting protein kinase 1 (RIPK1', 'placebo']","['safety, tolerability pharmacokinetics, pharmacodynamics', 'epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis', 'Plaque Lesion Severity Sum', 'adverse events (AEs']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0241148', 'cui_str': 'Cutaneous plaque'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.614395,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berger', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'InnovaDerm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Scott', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Tompson', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Simeoni', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bertin', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Peter Tak', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1852']
209,32300859,Scheduled intravenous acetaminophen versus nonsteroidal anti-inflammatory drugs (NSAIDs) for better short-term outcomes after esophagectomy for esophageal cancer.,"PURPOSE


To evaluate the effect of scheduled intravenous acetaminophen administration versus nonsteroidal anti-inflammatory drugs on postoperative pain and short-term outcomes after esophagectomy.
METHODS


The subjects of this study were 150 consecutive patients who underwent esophagectomy for esophageal cancer. Seventy-seven patients received scheduled intravenous acetaminophen and the other 73 received NSAIDs enterally for postoperative pain management. We compared the postoperative pain and short-term outcomes between the groups. Inverse probability of treatment weighting (IPTW) based on propensity scores was used to control for selection bias.
RESULTS


The visual analog scale (VAS) of postoperative pain was lower in the acetaminophen group than in the NSAIDs group, based on the mean values of chest VAS on postoperative days (PODs) 0, 4, 5, and 6 and the mean values of abdomen VAS on PODs 4, 5, and 6. The incidence of anastomotic leakage and postoperative delirium was lower in the acetaminophen group than in the NSAIDs group (anastomotic leakage, odds ratio (OR) 0.3, p = 0.01; postoperative delirium, OR 0.19, p < 0.01).
CONCLUSION


Scheduled intravenous acetaminophen administration is effective and feasible for the postoperative pain management of patients undergoing esophagectomy and may be associated with a lower incidence of anastomotic leakage and postoperative delirium.",2020,"The visual analog scale (VAS) of postoperative pain was lower in the acetaminophen group than in the NSAIDs group, based on the mean values of chest VAS on postoperative days (PODs) 0, 4, 5, and 6 and the mean values of abdomen VAS on PODs 4, 5, and 6.","['150 consecutive patients who underwent esophagectomy for esophageal cancer', 'Seventy-seven patients received scheduled', 'esophageal cancer', 'patients undergoing esophagectomy']","['acetaminophen', 'intravenous acetaminophen', 'nonsteroidal anti-inflammatory drugs (NSAIDs', 'NSAIDs enterally for postoperative pain management', 'nonsteroidal anti-inflammatory drugs']","['postoperative delirium', 'postoperative pain', 'incidence of anastomotic leakage and postoperative delirium', 'postoperative pain and short-term outcomes', 'visual analog scale (VAS) of postoperative pain']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",150.0,0.0354133,"The visual analog scale (VAS) of postoperative pain was lower in the acetaminophen group than in the NSAIDs group, based on the mean values of chest VAS on postoperative days (PODs) 0, 4, 5, and 6 and the mean values of abdomen VAS on PODs 4, 5, and 6.","[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Kawakami', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan. tabe@aichi-cc.jp.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Higaki', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Fukaya', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Komori', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nakatochi', 'Affiliation': 'Department of Nursing, Nagoya University Graduate School of Medicine, 1-1-20 Daiko-Minami, Higashi-ku, Nagoya, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nagino', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}]",Surgery today,['10.1007/s00595-020-02001-x']
210,32300897,"Therapeutic effects of proprioceptive exercise on functional capacity, anxiety, and depression in patients with diabetic neuropathy: a 2-month prospective study.","BACKGROUND


Diabetic neuropathy (DN) is a common and serious complication of diabetes. DN patients are suffering from anxiety, depression, and impairment of functional capacity. Rare studies have assessed the effect of proprioceptive exercise training on anxiety, depression, and functional capacity in DN patients.
AIMS


This 2-month prospective study aims to investigate the effect of proprioceptive exercise training on anxiety, depression, and functional capacity in DN patients.
METHODS


Twenty-eight DN patients with a mean age of 53.2 ± 5.5 years were included in this prospective study between September and December 2019. They were randomly assigned into two groups, 14 in each group using a random number generator. The proprioceptive exercise group (PEG) received a program of proprioceptive exercise, while the control group (CG) received a conventional treatment without exercise intervention. Berg Balance Scale (BBS), Six-Minute Walk Test (6MWT), Beck Anxiety Inventory (BAI), and Hamilton Depression Rating Scale (HDRS) were investigated before and after 2 months of the study period.
RESULTS


The findings showed a significant improvement of the BBS, 6MWT, BAI, and HDRS in the PEG (p = 0.003, p < 0.001, p = 0.001, and p = 0.001, respectively) while non-significant changes in the CG (p > 0.05). Comparison between the two groups showed significant differences between the two groups in the all outcome measures in favor of the PEG at the end of the 2 months (BBS, p = 0.032; 6MWT, p = 0.001; BAI, p = 0.031; and HDRS, p = 0.013).
CONCLUSIONS


Two months of proprioceptive exercise may improve functional capacity, anxiety, and depression in DN patients. Serious recommendations should be devoted to encouraging the proprioceptive exercise training among different population, especially DN patients. Key Points • Proprioceptive exercise may improve postural stability in patients with diabetic neuropathy. • Proprioceptive exercise may improve psychological status and functional capacity in patients with diabetic neuropathy. • Serious recommendations should be devoted to encouraging the proprioceptive exercise training among diabetic patients.",2020,"Comparison between the two groups showed significant differences between the two groups in the all outcome measures in favor of the PEG at the end of the 2 months (BBS, p = 0.032; 6MWT, p = 0.001; BAI, p = 0.031; and HDRS, p = 0.013).
","['patients with diabetic neuropathy', 'patients with diabetic neuropathy.•', 'DN patients', 'Twenty-eight DN patients with a mean age of 53.2\u2009±\u20095.5\xa0years were included in this prospective study between September and December 2019', 'diabetic patients', 'patients with diabetic neuropathy.• Serious recommendations']","['proprioceptive exercise', 'Key Points• Proprioceptive exercise', 'proprioceptive exercise training', 'Proprioceptive exercise', 'proprioceptive exercise group (PEG) received a program of proprioceptive exercise, while the control group (CG) received a conventional treatment without exercise intervention']","['BBS, 6MWT, BAI, and HDRS in the PEG', 'functional capacity, anxiety, and depression', 'anxiety, depression, and functional capacity', 'Berg Balance Scale (BBS), Six-Minute Walk Test (6MWT), Beck Anxiety Inventory (BAI), and Hamilton Depression Rating Scale (HDRS', 'postural stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0160637,"Comparison between the two groups showed significant differences between the two groups in the all outcome measures in favor of the PEG at the end of the 2 months (BBS, p = 0.032; 6MWT, p = 0.001; BAI, p = 0.031; and HDRS, p = 0.013).
","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia. walidkamal.wr@gmail.com.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Yassen', 'Affiliation': 'Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Ahmed', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Clinical rheumatology,['10.1007/s10067-020-05086-4']
211,32301853,Effect of Strength Training on Glycemic Control and Adiponectin in Diabetic Children.,"PURPOSE


This study aimed to examine the effect of isolated supervised progressive resistance training with duration of more than 32 wk on muscle strength, metabolic control and adiponectin.
METHOD


Twenty-one children with type 1 diabetes mellitus were separated into an intervention group (IG) (n = 11 age 11.0 ± 0.8) and a control group (CG) (n = 10 age 11.30 ± 0.7) without training to control for the effect of progressive resistance training on muscle strength, hemoglobin (HbA)1C and adiponectin. All parameters were assessed before and after a period of 32 wk. No attempt was made to change diet and the daily behaviors during the study in both groups.
RESULTS


After a period of 32 wk, upper and lower limb strength increased significantly (P < 0.05) in the IG, whereas no changes occurred in the CG. In the IG, HbA1C decreased significantly after 32 wk but not after 17 wk (P < 0.00), whereas HbA1C increased in the CG (P < 0.007). Adiponectin increased significantly (P < 0.000) only in the IG. Self-monitored blood glucose levels, measured before and after each session, showed a significant reduction (P < 0.00) of 26.5% ± 4.4% after each session. Effect size (ES) for the strength training on limb strength was medium (d = 0.464 to d = 0.661), the ES for strength training on HbA1C (d = -1.292) and the ES for strength training on adiponectin (d = 1.34) was large. There was no hypoglycemia as the result of training.
CONCLUSIONS


An isolated supervised progressive resistance training two times a week in children with type 1 diabetes mellitus must last at least 32 wk to get a significant decrease in blood glucose level HbA1C. In addition, exercise-induced increase in adiponectin improves insulin sensitivity.",2020,In the IG HbA1C decreased significantly after 32 weeks but not after 17 weeks (p<0.00) while HbA1C increased in the CG (p<0.007).,"['Diabetic Children', 'Twenty one children with Type 1 DM diabetes']","['control group (CG n = 10 age 11.30 ± 0.7) without training to control', 'Strength Training', 'isolated supervised progressive resistance training', 'progressive resistance training']","['hypoglycemia', 'HbA1C', 'blood glucose level HbA1C', 'adiponectin improves insulin sensitivity', 'limb strength', 'Glycemic Control and Adiponectin', 'Adiponectin', 'Self-monitored blood glucose levels', 'muscle strength, metabolic control and adiponectin']","[{'cui': 'C0425067', 'cui_str': 'Diabetic child'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",21.0,0.0111125,In the IG HbA1C decreased significantly after 32 weeks but not after 17 weeks (p<0.00) while HbA1C increased in the CG (p<0.007).,"[{'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Petschnig', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Danube Hospital Vienna, AUSTRIA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': 'Department of Pediatric, Danube Hospital, Vienna, AUSTRIA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Robubi', 'Affiliation': 'Department of Chemistry, Danube Hospital, Vienna, AUSTRIA.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Baron', 'Affiliation': 'Institute of Sport Science, Department of Prevention-Rehabilitation and Science of Training, University of Vienna, Vienna, AUSTRIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002356']
212,32299247,Objective and subjective vasomotor symptom outcomes in the CBT-Meno randomized controlled trial.,"Objective:  Vasomotor symptoms (hot flashes, night sweats) are common during the menopausal transition. Pharmacotherapy is effective but is associated with health risks for some women. There is an increasing demand for non-pharmacological interventions. The CBT-Meno protocol is a psychological intervention targeting a range of common menopausal symptoms. We compared the impact of CBT-Meno vs. waitlist on objective and subjective measures of vasomotor symptoms and on the relationship between vasomotor symptoms and sleep difficulties. Materials:  The participants were 36 perimenopausal or postmenopausal women with co-occurring depressive symptoms who participated in the CBT-Meno trial (clinicaltrials.gov NCT02480192). Subjective measures included the Hot Flash Related Daily Interference Scale, the Greene Climacteric Scale, and the Pittsburgh Sleep Quality Inventory. Objective (physiological) and 'in-the-moment' measures of vasomotor symptoms were assessed with sternal skin conductance. Results:  Greater improvements in vasomotor 'bothersomeness' and 'interference' were observed in the CBT-Meno condition compared to the waitlist condition. No between-group differences were observed in vasomotor frequency (subjectively or objectively recorded) or severity ratings. Sleep disturbance was unrelated to objectively measured vasomotor symptom frequency. Conclusion:  The CBT-Meno trial improved subjective but not objective (physiological) measures of vasomotor symptoms. Self-reported sleep difficulties were unrelated to subjective or objective vasomotor symptoms.",2020,Results:  Greater improvements in vasomotor 'bothersomeness' and 'interference' were observed in the CBT-Meno condition compared to the waitlist condition.,['participants were 36 perimenopausal or postmenopausal women with co-occurring depressive symptoms who participated in the CBT-Meno trial (clinicaltrials.gov NCT02480192'],"['Pharmacotherapy', 'CBT-Meno vs. waitlist']","['vasomotor frequency (subjectively or objectively recorded) or severity ratings', 'Sleep disturbance', 'Objective and subjective vasomotor symptom outcomes', 'Hot Flash Related Daily Interference Scale, the Greene Climacteric Scale, and the Pittsburgh Sleep Quality Inventory', 'sternal skin conductance', 'vasomotor symptoms and sleep difficulties', ""vasomotor 'bothersomeness' and 'interference"", 'Vasomotor symptoms (hot flashes, night sweats']","[{'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0448823', 'cui_str': 'Sternal skin'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}]",,0.0745349,Results:  Greater improvements in vasomotor 'bothersomeness' and 'interference' were observed in the CBT-Meno condition compared to the waitlist condition.,"[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Donegan', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'McCabe', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Fedorkow', 'Affiliation': 'Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Frey', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2020.1737929']
213,31957963,"Intraaortic balloon pump in myocardial infarction: Always, Never, or for the Right Patient?",SEMPER FI was a 100-patient pilot study that randomized acute myocardial infarction (AMI) patients with persistent ischemia following percutaneous coronary intervention (PCI) to intraaortic balloon pump (IABP) versus control. AMI patients with persistent ischemia receiving short-term IABP post-PCI had a greater resolution of persistent ST segment elevation and a trend for decreased clinical events. These results support a larger adequately powered trial of IABP versus control in AMI patients with persistent ischemia following primary PCI.,2020,AMI patients with persistent ischemia receiving short-term IABP post-PCI had a greater resolution of persistent ST segment elevation and a trend for decreased clinical events.,"['AMI patients with persistent ischemia receiving short-term IABP post-PCI', 'myocardial infarction', 'AMI patients with persistent ischemia following primary PCI']","['percutaneous coronary intervention (PCI) to intraaortic balloon pump (IABP', 'Intraaortic balloon pump', 'IABP']",['resolution of persistent ST segment elevation'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump, device (physical object)'}]","[{'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}]",,0.0672327,AMI patients with persistent ischemia receiving short-term IABP post-PCI had a greater resolution of persistent ST segment elevation and a trend for decreased clinical events.,"[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Tyler', 'Affiliation': 'Cardiovascular Division, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Christ Hospital Heart and Vascular Center, The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28683']
214,31436395,Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment.,"BACKGROUND


Inotuzumab Ozogamicin (INO), has demonstrated an improvement in overall survival, high rate of complete remission, favorable patient-reported outcomes, and manageable safety profile vs standard of care (SoC; intensive chemotherapy) for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) in the phase 3 INO-VATE trial. With a one-hour weekly dosing schedule, INO might be associated with lower healthcare system burden. This study analyses hospitalizations for INO vs SoC.
METHODS


All patients receiving study treatment in the INO-VATE trial were included. The days hospitalized during study treatment was calculated. Due to different treatment durations for INO and SoC (median of 3 vs 1 cycles), number of hospital days was mainly reported per observed patient month. Hospital days per patient month were analyzed for different treatment cycles, subgroups, and main reasons for hospitalization. Differences between treatments were analyzed by the incidence rate ratio (IRR).
RESULTS


Overall, 82.9% and 94.4% INO and SoC patients experienced at least one hospitalization. The mean hospitalization days per patient month was 7.6 and 18.4 days for INO and SoC (IRR = 0.413, P < .001), which corresponds to patients spending 25.0% and 60.5% of their treatment time in a hospital. Main hospitalization reasons were R/R ALL treatment (5.2 (INO) vs 14.0 (SoC) days, IRR = 0.368, P < .001), treatment toxicities (1.4 vs 2.8 days, IRR = 0.516, P < .001) or other reasons (1.0 vs 1.6 days, IRR 0.629, P < .001).
CONCLUSIONS


Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC. It is likely this lower burden has a favorable impact on healthcare budgets and cost-effectiveness considerations.",2019,"CONCLUSIONS


Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC.","['All patients receiving study treatment in the INO-VATE trial were included', 'acute lymphoblastic leukemia patients treated with']","['Inotuzumab Ozogamicin', 'Inotuzumab Ozogamicin versus standard chemotherapy treatment']","['number of hospital days', 'incidence rate ratio (IRR', 'overall survival', 'treatment toxicities', 'mean hospitalization days per patient month', 'Burden of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0439669,"CONCLUSIONS


Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'van Oostrum', 'Affiliation': 'Ingress-Health Nederland B.V., Rotterdam, The Netherlands.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Mueller', 'Affiliation': 'Ingress-Health HWM GmbH, Wismar, Germany.'}, {'ForeName': 'Verna', 'Initials': 'V', 'LastName': 'Welch', 'Affiliation': 'Pfizer Global HEOR, New York, NY, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vandendries', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Fausto R', 'Initials': 'FR', 'LastName': 'Loberiza', 'Affiliation': 'Pfizer Inc, Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Böhme', 'Affiliation': 'Pfizer Deutschland GmbH, Berlin, Germany.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Independent, Bridgewater, NJ, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Cancer medicine,['10.1002/cam4.2480']
215,31050109,Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized trial.,"This report describes novel clinical data assessing the pharmacodynamics of insulin glargine/lixisenatide (iGlarLixi) compared with placebo and insulin glargine alone, to determine pharmacokinetics of lixisenatide, and to assess safety of iGlarLixi in Japanese people with type 2 diabetes mellitus (T2DM). In a single-centre, open-label, randomized, placebo-controlled cross-over study, participants received subcutaneous iGlarLixi 5 U/5 μg and 10 U/10 μg, placebo, and 5 U insulin glargine. The primary endpoint was area under the postprandial plasma glucose (PPG) curve (AUC 0-2h  ). A total of 20 participants completed all study periods. iGlarLixi 5 U/5 μg and 10 U/10 μg reduced mean PPG dose-dependently compared with placebo and insulin glargine 5 U. Both combinations significantly reduced PPG-AUC 0-2h  dose-dependently compared with placebo (least squares mean difference -7.48 mmol h/L for 5 U/5 μg, -10.75 mmol h/L for 10 U/10 μg; P < 0.0001). iGlarLixi 5 U/5 μg reduced PPG-AUC 0-2h  significantly compared with insulin glargine 5 U (-0.76 mmol h/L; P < 0.0001). No symptomatic hypoglycaemia occurred during the study. iGlarLixi single subcutaneous injections significantly and dose-dependently reduced PPG compared to placebo or insulin glargine in Japanese participants with T2DM. iGlarLixi was safe and well tolerated, and would be expected to provide the 24-hour plasma glucose-lowering effects of insulin glargine and the postprandial antihyperglycaemic effects of lixisenatide.",2019,iGlarLixi single subcutaneous injections significantly and dose-dependently reduced PPG compared to placebo or insulin glargine in Japanese participants with T2DM.,"['Japanese participants with T2DM', '20 participants completed all study periods', 'Japanese patients with type 2 diabetes mellitus', 'Japanese people with type 2 diabetes mellitus (T2DM']","['placebo', 'iGlarLixi', 'placebo and insulin glargine', 'insulin glargine', 'subcutaneous iGlarLixi 5 U/5 μg and 10 U/10 μg, placebo, and 5 U insulin glargine', 'insulin glargine/lixisenatide (iGlarLixi', 'insulin glargine/lixisenatide fixed ratio combination (iGlarLixi']","['safe and well tolerated', 'PPG-AUC', 'PPG', 'area under the postprandial plasma glucose (PPG) curve (AUC 0-2h  ', 'symptomatic hypoglycaemia', 'postprandial glucodynamic response']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4293375', 'cui_str': 'Insulin Glargine / Lixisenatide'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",20.0,0.245239,iGlarLixi single subcutaneous injections significantly and dose-dependently reduced PPG compared to placebo or insulin glargine in Japanese participants with T2DM.,"[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lorenz', 'Affiliation': 'Research & Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Hideya', 'Initials': 'H', 'LastName': 'Muto', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wesch', 'Affiliation': 'Research & Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13757']
216,30884006,Optimizing ablation duration using dormant conduction to reveal incomplete isolation with the second generation cryoballoon: A randomized controlled trial.,"INTRODUCTION


Efficacy of cryoballoon ablation depends on balloon-tissue contact and ablation duration. Prolonged duration may increase extracardiac complications. The aim of this study is to determine the optimal additional ablation duration after acute pulmonary vein isolation (PVI).
METHODS


Consecutive patients with paroxysmal AF were randomized to three groups according to additional ablation duration (90, 120, or 150 seconds) after acute PVI (time-to-isolation). Primary outcome was reconnection/dormant conduction (DC) after a 30 minutes waiting period. If present, additional 240 seconds ablations were performed. Ablations without time-to-isolation <90 seconds, esophageal temperature <18°C or decreased phrenic nerve capture were aborted. Patients were followed with 24-hour Holter monitoring at 3, 6, and 12 months.
RESULTS


Seventy-five study patients (60 ± 11 years, 48 male) were included. Reconnection/DC per vein significantly decreased (22%, 6% and 4%) while aborted ablations remained stable (respectively 4, 5, and 7%) among the 90, 120, and 150 seconds groups. A shorter cryo-application time, longer time-to-isolation, higher balloon temperature and unsuccessful ablations predicted reconnection/DC. Freedom of atrial fibrillation was, respectively, 52, 56, and 72% in 90, 120, and 150 seconds groups ( P = 0.27), while repeated procedures significantly decreased from 36% to 4% ( P = 0.041) in the longer duration group compared to shorter duration group (150 seconds vs 90 seconds group). In multivariate Cox-regression only reconnection/DC predicted recurrence.
CONCLUSION


Prolonging ablation duration after time-to-isolation significantly decreased reconnection/DC and repeated procedures, while recurrences and complications rates were similar. In a time-to-isolation approach, an additional ablation of 150 seconds ablation is the most appropriate.",2019,"Reconnection/DC per vein significantly decreased (22%, 6% and 4%) while aborted ablations remained stable (respectively 4, 5, and 7%) among the 90, 120, and 150 seconds groups.","['Consecutive patients with paroxysmal AF', 'Seventy-five study patients (60\u2009±\u200911 years, 48 male) were included']",['cryoballoon ablation'],"['extracardiac complications', 'balloon-tissue contact and ablation duration', 'reconnection/dormant conduction (DC', 'phrenic nerve capture', 'cryo-application time, longer time-to-isolation, higher balloon temperature and unsuccessful ablations predicted reconnection/DC', 'Reconnection/DC per vein', 'Freedom of atrial fibrillation', 'recurrences and complications rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0031774', 'cui_str': 'Phrenic Nerve'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",75.0,0.056165,"Reconnection/DC per vein significantly decreased (22%, 6% and 4%) while aborted ablations remained stable (respectively 4, 5, and 7%) among the 90, 120, and 150 seconds groups.","[{'ForeName': 'Fehmi', 'Initials': 'F', 'LastName': 'Keçe', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'de Riva', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Naruse', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadeh Dehnavi', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Adrianus P', 'Initials': 'AP', 'LastName': 'Wijnmaalen', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Schalij', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Zeppenfeld', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Trines', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13913']
217,31124299,Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial.,"In this post hoc analysis of the randomized controlled LixiLan-O trial in insulin-naive patients with type 2 diabetes mellitus (T2DM) not controlled with metformin, with or without a second oral antihyperglycaemic drug (OAD), the efficacy and safety of the fixed-ratio combination, iGlarLixi (insulin glargine 100 U [iGlar] and lixisenatide [Lixi]), compared to its individual components was assessed in two patient subgroups: group 1) baseline HbA1c ≥9% (n = 134); group 2) inadequate control (HbA1c ≥7.0% and ≤9.0%) despite administration of two OADs at screening (n = 725). Treatment with iGlarLixi resulted in significantly greater reduction in least squares mean HbA1c compared to treatment with iGlar or Lixi alone in both subgroups (group 1: 2.9%, 2.5%, 1.7% and group 2: 1.5%, 1.2%, 0.7%, respectively). Target HbA1c less than 7% was achieved in more than 70% of patients using iGlarLixi in both subgroups, while mitigating the weight gain observed with use of iGlar alone. Rates of hypoglycaemic events were low overall. These results suggest that treatment with iGlarLixi achieves superior glycaemic control compared to treatment with iGlar or Lixi alone in T2DM patients with HbA1c ≥9% or in those inadequately controlled with two OADs.",2019,"Treatment with iGlarLixi resulted in significantly greater reduction in least squares mean HbA1c compared to treatment with iGlar or Lixi alone in both subgroups (group 1: 2.9%, 2.5%, 1.7% and group 2: 1.5%, 1.2%, 0.7%, respectively).","['insulin-naive patients with type 2 diabetes mellitus (T2DM', 'insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial', 'two patient subgroups: group 1) baseline HbA1c ≥9% (n =\u2009134); group 2) inadequate control (HbA1c ≥7.0% and\u2009≤9.0%) despite administration of two OADs at screening (n =\u2009725']","['iGlarLixi', 'iGlarLixi (insulin glargine 100\u2009U [iGlar] and lixisenatide [Lixi', 'metformin, with or without a second oral antihyperglycaemic drug (OAD']","['Rates of hypoglycaemic events', 'weight gain']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.0439103,"Treatment with iGlarLixi resulted in significantly greater reduction in least squares mean HbA1c compared to treatment with iGlar or Lixi alone in both subgroups (group 1: 2.9%, 2.5%, 1.7% and group 2: 1.5%, 1.2%, 0.7%, respectively).","[{'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Department of Health Services, Diabetes Research Centre, University of Leicester, Leicester General Hospital and University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Russell-Jones', 'Affiliation': 'Department of Diabetes and Endocrinology, University of Surrey, Guildford, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Barber', 'Affiliation': 'Translational Medicine, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Lavalle-González', 'Affiliation': 'Department of Endocrinology, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Mexico.'}, {'ForeName': 'Gagik R', 'Initials': 'GR', 'LastName': 'Galstyan', 'Affiliation': 'Diabetic Foot Department, Endocrinology Research Center, Moscow, Russia.'}, {'ForeName': 'Dalong', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Affiliated Drum Tower Hospital, Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Baxter', 'Affiliation': 'Sanofi, Guildford, UK.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Dessapt-Baradez', 'Affiliation': 'Sanofi, Guildford, UK.'}, {'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13791']
218,32297279,Feasibility and Outcome of a Phase II Study of Intensive Induction Chemotherapy in 91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment.,"INTRODUCTION


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


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


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


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


The study was registered with the Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.",2020,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","['149 patients with acute myeloid leukaemia (AML) aged ≥', '91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment', 'Ninety-one fully or partially fit patients (61', 'and 58 (39%) frail patients to best supportive care (BSC']","['Intensive Induction Chemotherapy', 'MGA', 'intensive chemotherapy', 'aracytin and idarubicin plus amifostine']","['8-year overall survival (OS', 'early death and complete response (CR) rate']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015020', 'cui_str': 'Amifostine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",149.0,0.066301,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Capelli', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy. debora.capelli@ospedaliriuniti.marche.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Saraceni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fiorentini', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Chiarucci', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Menotti', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Poloni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Discepoli', 'Affiliation': 'Cytogenetic Laboratory, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ospedale Salesi, via F. Corridoni, 11, 60100, Ancona, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Leoni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Olivieri', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01310-4']
219,32297283,OPADIA Study: Is a Patient Questionnaire Useful for Enhancing Physician-Patient Shared Decision Making on Physical Activity Micro-objectives in Diabetes?,"INTRODUCTION


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


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


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


Although the OPTIMA-PA questionnaire did not directly promote setting up of SMART-PA micro-objectives in T2DM patients, the OPADIA study demonstrated that this tool was effective at improving patient-physician relationships by increasing patient involvement in therapeutic decision making. Our study also highlighted the importance of GP aptitude for patient-centredness for improving PA in T2DM patients.",2020,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","['Physicians participating in this multicentre', 'T2DM patients', 'One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group']","['standard group (T2DM patients managed according to usual clinical practice, n\u2009=\u200924) or the OPTIMA-PA', 'Regular physical activity (PA']","['percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective', 'patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0003646', 'cui_str': 'Aptitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",122.0,0.0234986,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","[{'ForeName': 'Silla M', 'Initials': 'SM', 'LastName': 'Consoli', 'Affiliation': 'Paris Descartes University of Medicine, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University-Hospital (CHU), G. Montpied Hospital, INRA, UMR 1019, UNH, CRNH Auvergne, Clermont University, University of Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'Service de diabétologie, Institut E3M, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': ""Service d'endocrinologie, diabétologie et maladies métaboliques, Centre Hospitalier Sud-Francilien de Corbeil-Essonnes, Université Paris-Saclay, Orsay, France.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bineau', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Sabin', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Pouriel', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Freund', 'Affiliation': 'Clintec International SARL, Tour D2, 17 bis place des Reflets, 92099, La Défense, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Dejager', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France. sylvie.dejager@msd.com.'}]",Advances in therapy,['10.1007/s12325-020-01336-8']
220,31877062,Shoe Cushioning Influences the Running Injury Risk According to Body Mass: A Randomized Controlled Trial Involving 848 Recreational Runners.,"BACKGROUND


Shoe cushioning is expected to protect runners against repetitive loading of the musculoskeletal system and therefore running-related injuries. Also, it is a common belief that heavier runners should use footwear with increased shock absorption properties to prevent injuries.
PURPOSE


The aim of this study was to determine if shoe cushioning influences the injury risk in recreational runners and whether the association depends on the runner's body mass.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Healthy runners (n = 848) randomly received 1 of 2 shoe prototypes that only differed in their cushioning properties. Global stiffness was 61.3 ± 2.7 and 94.9 ± 5.9 N/mm in the soft and hard versions, respectively. Participants were classified as light or heavy according to their body mass using the median as a cut-off (78.2 and 62.8 kg in male and female runners, respectively). They were followed over 6 months regarding running activity and injury (any physical complaint reducing/interrupting running activity for at least 7 days). Data were analyzed through time-to-event models with the subhazard rate ratio (SHR) and their 95% confidence interval (CI) as measures of association. A stratified analysis was conducted to investigate the effect of shoe cushioning on the injury risk in lighter and heavier runners.
RESULTS


The runners who had received the hard shoes had a higher injury risk (SHR, 1.52 [95% CI, 1.07-2.16]), while body mass was not associated with the injury risk (SHR, 1.00 [95% CI, 0.99-1.01]). However, after stratification according to body mass, results showed that lighter runners had a higher injury risk in hard shoes (SHR, 1.80 [95% CI, 1.09-2.98]) while heavier runners did not (SHR, 1.23 [95% CI, 0.75-2.03]).
CONCLUSION


The injury risk was higher in participants running in the hard shoes compared with those using the soft shoes. However, the relative protective effect of greater shoe cushioning was found only in lighter runners.
REGISTRATION


NCT03115437 (ClinicalTrials.gov identifier).",2020,"The runners who had received the hard shoes had a higher injury risk (SHR, 1.52 [95% CI, 1.07-2.16]), while body mass was not associated with the injury risk (SHR, 1.00 [95% CI, 0.99-1.01]).","['lighter and heavier runners', 'Participants were classified as light or heavy according to their body mass using the median as a cut-off (78.2 and 62.8 kg in male and female runners, respectively', 'heavier runners', '848 Recreational Runners', 'recreational runners', 'Healthy runners (n = 848']",[],"['higher injury risk', 'subhazard rate ratio (SHR', 'injury risk']","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1518543', 'cui_str': 'Off (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0582456', 'cui_str': 'At risk of injury'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",848.0,0.295231,"The runners who had received the hard shoes had a higher injury risk (SHR, 1.52 [95% CI, 1.07-2.16]), while body mass was not associated with the injury risk (SHR, 1.00 [95% CI, 0.99-1.01]).","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Malisoux', 'Affiliation': 'Sports Medicine Research Laboratory, Luxembourg Institute of Health, Luxembourg, Grand Duchy of Luxembourg.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delattre', 'Affiliation': ""Movement Sciences Department, Decathlon SportsLab, Villeneuve d'Ascq, France.""}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Urhausen', 'Affiliation': 'Sports Medicine Research Laboratory, Luxembourg Institute of Health, Luxembourg, Grand Duchy of Luxembourg.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Theisen', 'Affiliation': 'Sports Medicine Research Laboratory, Luxembourg Institute of Health, Luxembourg, Grand Duchy of Luxembourg.'}]",The American journal of sports medicine,['10.1177/0363546519892578']
221,31429205,Phase I trial of TAK-385 in hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer.,"This open-label, phase I dose-finding study evaluated the gonadotropin-releasing hormone antagonist, TAK-385, in Japanese patients with nonmetastatic prostate cancer. In a two-part design, patients received daily oral TAK-385 at doses of 320 (loading, day 1)/80 (maintenance, day 2 and thereafter), 320/120, 320/160, or 360/120 mg for 28 days in a dose-escalation phase (part A, n = 13), and at 320/80 or 320/120 mg for up to 96 weeks in a randomized expansion phase (part B, n = 30). Primary endpoint in both parts was safety, including dose-limiting toxicity in part A. Secondary endpoints included pharmacokinetics, pharmacodynamics, and prostate-specific antigen concentration. Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent. No dose-limiting toxicities were observed (part A). In 12 evaluable patients (part A), TAK-385 was rapidly absorbed after a single loading dose; on day 28 (maintenance dose), median steady-state T max  was ~1-2 hours and mean t 1/2z  was 67-79 hours. All doses rapidly reduced testosterone concentrations to castration levels within 1 week. Durable reductions in prostate-specific antigen of >90% from baseline were observed through 96 weeks. TAK-385 appeared tolerable and resulted in sustained reductions in testosterone to castration levels at all doses. The lowest loading/maintenance dose required for a clinical effect was 320/80 mg. ClinicalTrials.gov: NCT02141659.",2019,"Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent.","['Japanese patients with nonmetastatic prostate cancer', 'hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer']","['gonadotropin-releasing hormone antagonist, TAK-385', 'TAK-385', 'daily oral TAK-385']","['viral upper respiratory tract infection', 'testosterone concentrations to castration levels', 'No dose-limiting toxicities', 'pharmacokinetics, pharmacodynamics, and prostate-specific antigen concentration', 'safety, including dose-limiting toxicity', 'diarrhea', 'median steady-state T max']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C3252109', 'cui_str': 'TAK 385'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0339916', 'cui_str': 'Viral upper respiratory tract infection (disorder)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0198171,"Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent.","[{'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Toho University Sakura Medical Center, Chiba, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mizokami', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Narihiko', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Department of Urology, Public University Corporation Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nagamori', 'Affiliation': 'Department of Urology, Incorporated Administrative Agency National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Enomoto', 'Affiliation': 'Department of Urology, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Akaza', 'Affiliation': 'Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies/Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Asato', 'Affiliation': 'Oncology Clinical Research Department, Oncology Therapeutic Area Unit for Japan and Asia, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Tadayuki', 'Initials': 'T', 'LastName': 'Kitagawa', 'Affiliation': 'Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Graduate School of Medicine, National University Corporation Gunma University, Maebashi, Japan.'}]",Cancer medicine,['10.1002/cam4.2442']
222,32276609,"A comparison of the efficacy of three different peak airway pressures on intraoperative bleeding point detection in patients undergoing thyroidectomy: a randomized, controlled, clinical trial.","BACKGROUND


Various techniques are used to detect intraoperative bleeding points in thyroid surgery. We aimed to assess the effect of increasing peak airway pressure to 30, 40 and 50 cm H 2 O manually in detecting intraoperative bleeding points.
METHODS


One hundred and 34 patients scheduled for total thyroidectomy were included to this prospective randomised controlled clinical study. We randomly assigned patients to increase peak airway pressure to 30, 40 and 50 cm H 2 O manually intraoperatively just before surgical closure during hemostasis control. The primary endpoint was the rate of bleeding points detected by the surgeon during peak airway pressure increase.
RESULTS


The rate of detection of the bleeding points was higher in 50 cm H 2 O Group than the other two groups (15.9 vs 25.5 vs 40%, P = 0.030), after pressure administration, the HR, SpO 2 , and P peak were similar between groups (P = 0.125, 0.196, 0.187, respectively). The median duration of the bleeding point detection after the pressure application was 21.82 s in 30 cm H 2 O, 25 s in 40 cm H 2 O, and 22.50 s in 50 cm H 2 O groups. Postoperative subcutaneous hematomas or hemorrhages requiring surgery were not seen in any patient.
CONCLUSIONS


Manually increasing peak airway pressure to 50 cm H 2 O during at least 22.50 s may be used as an alternative way to detect intraoperative bleeding points in thyroid surgery.
CLINICAL TRIAL REGISTRATION


NCT03547648. Registered 6 June2018.",2020,"The rate of detection of the bleeding points was higher in 50 cm H 2 O Group than the other two groups (15.9 vs 25.5 vs 40%, P = 0.030), after pressure administration, the HR, SpO 2 , and P peak were similar between groups (P = 0.125, 0.196, 0.187, respectively).","['patients undergoing thyroidectomy', 'One hundred and 34 patients scheduled for total thyroidectomy']",['peak airway pressures'],"['median duration of the bleeding point detection', 'rate of bleeding points detected by the surgeon during peak airway pressure increase', 'Postoperative subcutaneous hematomas or hemorrhages requiring surgery', 'rate of detection of the bleeding points', 'peak airway pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0520532', 'cui_str': 'Subcutaneous hematoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.179221,"The rate of detection of the bleeding points was higher in 50 cm H 2 O Group than the other two groups (15.9 vs 25.5 vs 40%, P = 0.030), after pressure administration, the HR, SpO 2 , and P peak were similar between groups (P = 0.125, 0.196, 0.187, respectively).","[{'ForeName': 'Cigdem Akyol', 'Initials': 'CA', 'LastName': 'Beyoglu', 'Affiliation': 'Istanbul University- Cerrahpasa Cerrahpasa School of Medicine, Department of Anaesthesiology and Reanimation, Kocamustafapasa Street, Fatih, Istanbul, Turkey. akyolbeyoglu@gmail.com.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Teksoz', 'Affiliation': 'Istanbul University- Cerrahpasa Cerrahpasa School of Medicine, Department of General Surgery, Kocamustafapasa Street Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Ozdilek', 'Affiliation': 'Istanbul University- Cerrahpasa Cerrahpasa School of Medicine, Department of Anaesthesiology and Reanimation, Kocamustafapasa Street, Fatih, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akcivan', 'Affiliation': 'Siirt State Hospital, Department of Anaesthesiology and Reanimation, Siirt, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Erbabacan', 'Affiliation': 'Istanbul University- Cerrahpasa Cerrahpasa School of Medicine, Department of Anaesthesiology and Reanimation, Kocamustafapasa Street, Fatih, Istanbul, Turkey.'}, {'ForeName': 'Fatis', 'Initials': 'F', 'LastName': 'Altindas', 'Affiliation': 'Istanbul University- Cerrahpasa Cerrahpasa School of Medicine, Department of Anaesthesiology and Reanimation, Kocamustafapasa Street, Fatih, Istanbul, Turkey.'}, {'ForeName': 'Guniz', 'Initials': 'G', 'LastName': 'Koksal', 'Affiliation': 'Istanbul University- Cerrahpasa Cerrahpasa School of Medicine, Department of Anaesthesiology and Reanimation, Kocamustafapasa Street, Fatih, Istanbul, Turkey.'}]",BMC surgery,['10.1186/s12893-020-00728-5']
223,31691287,Teacher Burnout and Contextual and Compositional Elements of School Environment.,"BACKGROUND


Teachers report higher levels of stress than most occupational groups. Burnout is a specific psychological condition that results from chronic job stress characterized by emotional exhaustion, low personal accomplishment, and depersonalization. This study considers associations between aspects of the school environment and teacher burnout.
METHODS


Exploratory analysis of baseline data from a cluster randomized controlled trial of 40 schools and 2278 teachers in the United Kingdom. Multilevel methods were used to consider the associations between different compositional and contextual aspects of the school environment and teacher burnout.
RESULTS


There was evidence for school effects on teacher burnout, evidenced by ICCs and likelihood ratio tests, supporting the association between school environment and teacher burnout. The factors most consistently associated with teacher burnout in our study were teachers' perceptions of the school's safety and support and student attitudes to learning.
CONCLUSIONS


The school environment does influence teacher burnout. More research is needed to develop and test causal pathways between the school environment and teacher burnout, and to understand ecological and individual predictors of teacher burnout and the interaction between the two.",2019,"There was evidence for school effects on teacher burnout, evidenced by ICCs and likelihood ratio tests, supporting the association between school environment and teacher burnout.",['40 schools and 2278 teachers in the United Kingdom'],[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]",[],[],2278.0,0.0294797,"There was evidence for school effects on teacher burnout, evidenced by ICCs and likelihood ratio tests, supporting the association between school environment and teacher burnout.","[{'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Shackleton', 'Affiliation': 'Centre of Methods and Policy Application in the Social Sciences (COMPASS), University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Faculty of Public Health and Policy, London School of Health and Tropical Medicine, 218, 15-17 Tavistock Place, London, WC1H 9SH, UK.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Jamal', 'Affiliation': 'Social Science Research Unit, Department of Childhood, Families and Health, University College London, Institute of Education, London, WC1H 0AL, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Health and Tropical Medicine, London, WC1E 7HT, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mathiot', 'Affiliation': 'General and Adolescent Paediatrics, Population, Policy & Practice Programme, Institute of Child Health, University College, London, WC1N 1EH, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'Department of Medical Statistics, London School of Health and Tropical Medicine, London, WC1E 7HT, UK.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Viner', 'Affiliation': 'Institute of Child Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.'}]",The Journal of school health,['10.1111/josh.12839']
224,31162192,Intracranial Hypertension and Cerebral Perfusion Pressure Insults in Adult Hypertensive Intraventricular Hemorrhage: Occurrence and Associations With Outcome.,"OBJECTIVES


Elevated intracranial pressure and inadequate cerebral perfusion pressure may contribute to poor outcomes in hypertensive intraventricular hemorrhage. We characterized the occurrence of elevated intracranial pressure and low cerebral perfusion pressure in obstructive intraventricular hemorrhage requiring extraventricular drainage.
DESIGN


Prospective observational cohort.
SETTING


ICUs of 73 academic hospitals.
PATIENTS


Four hundred ninety-nine patients enrolled in the CLEAR III trial, a multicenter, randomized study to determine if extraventricular drainage plus intraventricular alteplase improved outcome versus extraventricular drainage plus saline.
INTERVENTIONS


Intracranial pressure and cerebral perfusion pressure were recorded every 4 hours, analyzed over a range of thresholds, as single readings or spans (≥ 2) of readings after adjustment for intracerebral hemorrhage severity. Impact on 30- and 180-days modified Rankin Scale scores was assessed, and receiver operating curves were analyzed to identify optimal thresholds.
MEASUREMENTS AND MAIN RESULTS


Of 21,954 intracranial pressure readings, median interquartile range 12 mm Hg (8-16), 9.7% were greater than 20 mm Hg and 1.8% were greater than 30 mm Hg. Proportion of intracranial pressure readings from greater than 18 to greater than 30 mm Hg and combined intracranial pressure greater than 20 plus cerebral perfusion pressure less than 70 mm Hg were associated with day-30 mortality and partially mitigated by intraventricular alteplase. Proportion of cerebral perfusion pressure readings from less than 65 to less than 90 mm Hg and intracranial pressure greater than 20 mm Hg in spans were associated with both 30-day mortality and 180-day mortality. Proportion of cerebral perfusion pressure readings from less than 65 to less than 90 mm Hg and combined intracranial pressure greater than 20 plus cerebral perfusion pressure less than 60 mm Hg were associated with poor day-30 modified Rankin Scale, whereas cerebral perfusion pressure less than 65 and less than 75 mm Hg were associated with poor day-180 modified Rankin Scale.
CONCLUSIONS


Elevated intracranial pressure and inadequate cerebral perfusion pressure are not infrequent during extraventricular drainage for severe intraventricular hemorrhage, and level and duration predict higher short-term mortality and long-term mortality. Burden of low cerebral perfusion pressure was also associated with poor short- and long-term outcomes and may be more significant than intracranial pressure. Adverse consequences of intracranial pressure-time burden and cerebral perfusion pressure-time burden should be tested prospectively as potential thresholds for therapeutic intervention.",2019,"CONCLUSIONS


Elevated intracranial pressure and inadequate cerebral perfusion pressure are not infrequent during extraventricular drainage for severe intraventricular hemorrhage, and level and duration predict higher short-term mortality and long-term mortality.","['Four hundred ninety-nine patients enrolled in the CLEAR III trial', 'hypertensive intraventricular hemorrhage', 'obstructive intraventricular hemorrhage requiring extraventricular drainage', 'ICUs of 73 academic hospitals', 'Adult Hypertensive Intraventricular Hemorrhage']","['extraventricular drainage plus saline', 'extraventricular drainage plus intraventricular alteplase']","['intracranial pressure', 'Intracranial Hypertension and Cerebral Perfusion Pressure Insults', 'cerebral perfusion pressure readings', '21,954 intracranial pressure readings, median interquartile range', 'day-30 mortality', 'Intracranial pressure and cerebral perfusion pressure', 'cerebral perfusion pressure less', '30-day mortality and 180-day mortality', 'intracranial pressure readings', 'Elevated intracranial pressure and inadequate cerebral perfusion pressure', '30- and 180-days modified Rankin Scale scores']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C0151740', 'cui_str': 'Intracranial Pressure Increase'}, {'cui': 'C0428713', 'cui_str': 'Cerebral Perfusion Pressure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",499.0,0.11034,"CONCLUSIONS


Elevated intracranial pressure and inadequate cerebral perfusion pressure are not infrequent during extraventricular drainage for severe intraventricular hemorrhage, and level and duration predict higher short-term mortality and long-term mortality.","[{'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Division of Neurocritical Care, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Thompson', 'Affiliation': 'Biostatistics Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Mayo', 'Affiliation': 'Emissary International LLC, Austin, TX.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Freeman', 'Affiliation': 'Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dlugash', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ullman', 'Affiliation': 'Division of Neurocritical Care, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Awad', 'Affiliation': 'Section of Neurosurgery and the Neurovascular Surgery Program, University of Chicago Pritzker School of Medicine, Chicago, IL.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000003848']
225,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES


The objective of this study is to evaluate the progression and new onset of macular retinoschisis (MRS) in the patients treated with intravitreal Conbercept injections for myopic choroidal neovascularization (mCNV).
METHODS


Post-hoc analysis of 160 mCNV patients included in SHINY study was performed to evaluate the impact of Conbercept injection on MRS in patients with mCNV undergoing intravitreal Conbercept injections. The patients were 3:1 randomized to the study group (three loading dose and thereafter pro re nata [PRN]) and the control group (3 months' sham injection, then one Conbercept injection at month 4 and thereafter PRN). MRS was assessed with optical coherence tomography by masked graders.
RESULTS


At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers.
CONCLUSIONS


The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x']
226,31712614,Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.,"STUDY DESIGN


Multi-centre, double-blind randomised placebo-controlled study.
OBJECTIVE


To investigate whether the use of a multispecies probiotic can prevent antibiotic-associated diarrhoea in people with spinal cord injury (SCI).
SETTING


Three Dutch SCI rehabilitation centres.
METHODS


Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0). After cessation of the antibiotics (T1), the participants will use probiotics/placebo for 3 more weeks (T2). Defaecation, assessed by the Bristol Stool Scale, and bowel management will be monitored daily until 2 weeks after cessation of probiotics/placebo intake (T3). Also, the degree of nausea and information on quality of life will be collected at T0, T1, T2 and T3.
MAIN OUTCOME MEASURES


The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
SECONDARY OUTCOME MEASURES


The time to reach effective bowel management, degree of nausea and quality of life.
REGISTRATION


The Dutch Trial Register- NTR 5831.",2020,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","['persons with spinal cord injury', 'Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0', 'Three Dutch SCI rehabilitation centres', 'people with\xa0spinal cord injury (SCI']","['placebo', 'multispecies probiotic', 'probiotics/placebo']","['degree of nausea and information on quality of life', 'incidence of antibiotic-associated diarrhoea', 'Bristol Stool Scale, and bowel management', 'time to reach effective bowel management, degree of nausea and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea (disorder)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0222045'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",56.0,0.712196,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","[{'ForeName': 'W X M', 'Initials': 'WXM', 'LastName': 'Faber', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands. w.faber@heliomare.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nachtegaal', 'Affiliation': 'Department of Research & Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Stolwijk-Swuste', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Achterberg-Warmer', 'Affiliation': 'Amsterdam Rehabilitation Research Center, Reade, the Netherlands.'}, {'ForeName': 'C J M', 'Initials': 'CJM', 'LastName': 'Koning', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Besseling-van der Vaart', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'van Bennekom', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}]",Spinal cord,['10.1038/s41393-019-0369-y']
227,32293810,Microcurrent therapy in the treatment of knee osteoarthritis: could it be more than a placebo effect? A randomized controlled trial.,"BACKGROUND


Microcurrent therapy (MCT) is a novel electrotherapy modality with very low current-levels that may reduce pain especially in joints and muscles.
AIM


The aim of this study is to explore potential effects of MCT on pain in patients with knee osteoarthritis, to explore effects of different treatment parameters and to distinguish them from placebo-effects.
DESIGN


Randomized four arms controlled clinical trial.
SETTING


Outpatient tertiary medical care center.
POPULATION


Fifty-six patients with knee OA (Kellgren-Lawrence Score II or III, 14 male and 38 female, mean age: 71.7±7.3 years, pain intensity higher than Numeric Rating Scale [NRS] score 3 from 10).
METHODS


Patients were randomized into four groups: MCT with 100 µA (group A), MCT with 25 µA (group B), sham-treatment (group C) and a control-group without intervention. Treatment groups received 10 sessions of MCT for 30 minutes each over a period of 22 days. The primary outcome was daily pain intensity throughout the treatment period measured by a NRS from 0-10. Second outcome measurements were the Knee Osteoarthritis Outcome Score (KOOS), the SF-36 Questionnaire, the Six-Minute Walking Test and the Get-Up-and-Go Test.
RESULTS


Evening pain was reduced significantly in the verum-groups compared to sham group (Group A vs. Group C: P<0.001, Group B vs. Group C: P=0.006) and to no intervention (Group A vs. Group D: P<0.001, Group B vs. Group D: P=0.002). The difference between sham-therapy and no therapy was not significant. In the pre-post analysis of the KOOS group A improved significantly in the subscale Symptoms. Group A and B and D improved in the Activities of Daily Living subscale.
CONCLUSIONS


The results of this RCT suggest that MCT has beneficial effects on pain in patients with knee osteoarthritis that are not explained by a placebo effect. Due to the explorative, pilot character of the study, further confirmation is needed before clear recommendations can be given.
CLINICAL REHABILITATION IMPACT


More high-quality RCTs with transparent parameters should be investigated to elucidate potential effects of MCT in the field of physical medicine and rehabilitation. At the present time MCT is a treatment option that could be helpful, in particular for patients who are afraid of unpleasant sensations from electrotherapy with stronger currents.",2020,"RESULTS


Evening pain was reduced significantly in the verum-groups compared to sham group (Group A vs. Group C: p < 0.001, Group B vs. Group C: p= 0.006) and to no intervention (Group A vs. Group D: p< 0.001, Group B vs. Group D: p=0.002).","['knee osteoarthritis', 'Outpatient tertiary medical care center', '56 patients with knee OA (K&L-Score II or III), 14 male and 38 female, mean age: 71.7 (± 7.3), pain intensity higher than NRS 3 from 10.\nMETHODS\n\n\nPatients', 'patients with knee osteoarthritis']","['MCT with 25 μA', 'KOOS', 'MCT with 100 μA', 'Microcurrent therapy', 'MCT', 'control-group without intervention', 'Microcurrent therapy (MCT']","['Evening pain', 'daily pain intensity', 'Knee Osteoarthritis outcome score), the SF-36-Questionnaire, the 6-min-walking-test and the Get-up-and-go-test']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1303170', 'cui_str': 'Get up and go test'}]",56.0,0.134765,"RESULTS


Evening pain was reduced significantly in the verum-groups compared to sham group (Group A vs. Group C: p < 0.001, Group B vs. Group C: p= 0.006) and to no intervention (Group A vs. Group D: p< 0.001, Group B vs. Group D: p=0.002).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ranker', 'Affiliation': 'Department of Orthopedics, Physical Medicine, and Rehabilitation, University Hospital, Ludwig Maximilian University of Munich (LMU), Munich, Germany - alexander.ranker@gmail.com.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Husemeyer', 'Affiliation': 'Department of Orthopedics, Physical Medicine, and Rehabilitation, University Hospital, Ludwig Maximilian University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Cabeza-Boeddinghaus', 'Affiliation': 'Department of Orthopedics, Physical Medicine, and Rehabilitation, University Hospital, Ludwig Maximilian University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Mayer-Wagner', 'Affiliation': 'Department of Orthopedics, Physical Medicine, and Rehabilitation, University Hospital, Ludwig Maximilian University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Crispin', 'Affiliation': 'Institute for Medical Information Processing, Biometry, and Epidemiology, University Hospital, Ludwig Maximilian University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Weigl', 'Affiliation': 'Department of Orthopedics, Physical Medicine, and Rehabilitation, University Hospital, Ludwig Maximilian University of Munich (LMU), Munich, Germany.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.05921-3']
228,32289388,"A phase 2, multicenter, placebo-controlled study of single-dose squaric acid dibutyl ester to reduce frequency of outbreaks in patients with recurrent herpes labialis.",,2020,,[],[],[],[],[],[],,0.0560587,,"[{'ForeName': 'Anne Lynn S', 'Initials': 'ALS', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Golara', 'Initials': 'G', 'LastName': 'Honari', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Ludan', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Maria Alora', 'Initials': 'MA', 'LastName': 'Palli', 'Affiliation': 'Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Horn', 'Affiliation': 'Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Squarex, LLC, Pine Springs, Minnesota.'}, {'ForeName': 'Arkadiusz Z', 'Initials': 'AZ', 'LastName': 'Dudek', 'Affiliation': 'Squarex, LLC, Pine Springs, Minnesota.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'McTavish', 'Affiliation': 'Squarex, LLC, Pine Springs, Minnesota. Electronic address: hmctavish@squarex-pharma.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.021']
229,31557380,"Metformin blunts muscle hypertrophy in response to progressive resistance exercise training in older adults: A randomized, double-blind, placebo-controlled, multicenter trial: The MASTERS trial.","Progressive resistance exercise training (PRT) is the most effective known intervention for combating aging skeletal muscle atrophy. However, the hypertrophic response to PRT is variable, and this may be due to muscle inflammation susceptibility. Metformin reduces inflammation, so we hypothesized that metformin would augment the muscle response to PRT in healthy women and men aged 65 and older. In a randomized, double-blind trial, participants received 1,700 mg/day metformin (N = 46) or placebo (N = 48) throughout the study, and all subjects performed 14 weeks of supervised PRT. Although responses to PRT varied, placebo gained more lean body mass (p = .003) and thigh muscle mass (p < .001) than metformin. CT scan showed that increases in thigh muscle area (p = .005) and density (p = .020) were greater in placebo versus metformin. There was a trend for blunted strength gains in metformin that did not reach statistical significance. Analyses of vastus lateralis muscle biopsies showed that metformin did not affect fiber hypertrophy, or increases in satellite cell or macrophage abundance with PRT. However, placebo had decreased type I fiber percentage while metformin did not (p = .007). Metformin led to an increase in AMPK signaling, and a trend for blunted increases in mTORC1 signaling in response to PRT. These results underscore the benefits of PRT in older adults, but metformin negatively impacts the hypertrophic response to resistance training in healthy older individuals. ClinicalTrials.gov Identifier: NCT02308228.",2019,CT scan showed that increases in thigh muscle area (p = .005) and density (p = .020) were greater in placebo versus metformin.,"['healthy older individuals', 'healthy women and men aged 65 and older', 'older adults']","['Metformin', 'metformin', 'progressive resistance exercise training', 'placebo', '1,700\xa0mg/day metformin', 'CT scan', 'Progressive resistance exercise training (PRT']","['thigh muscle area', 'AMPK signaling', 'hypertrophic response', 'lean body mass', 'blunted strength gains', 'thigh muscle mass', 'satellite cell or macrophage abundance with PRT']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}]",,0.25806,CT scan showed that increases in thigh muscle area (p = .005) and density (p = .020) were greater in placebo versus metformin.,"[{'ForeName': 'R Grace', 'Initials': 'RG', 'LastName': 'Walton', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Cory M', 'Initials': 'CM', 'LastName': 'Dungan', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Long', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kosmac', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Bailey D', 'Initials': 'BD', 'LastName': 'Peck', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'Department of Biostatistics, College of Public Health, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Villasante Tezanos', 'Affiliation': 'Department of Statistics, College of Arts & Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Windham', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kern', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Peterson', 'Affiliation': 'Center for Muscle Biology, College of Health Sciences, University of Kentucky, Lexington, Kentucky.'}]",Aging cell,['10.1111/acel.13039']
230,30952216,Circadian Preference as a Moderator of Depression Outcome Following Cognitive Behavioral Therapy for Insomnia Plus Antidepressant Medications: A Report From the TRIAD Study.,"STUDY OBJECTIVES


We previously presented results from a randomized controlled trial that examined the effects of antidepressant medication plus cognitive behavioral therapy for insomnia (CBT-I) among patients with major depressive disorder (MDD) and insomnia. The current secondary analysis aims to examine whether circadian preference moderated the reduction in depression and insomnia symptom severity during this trial.
METHODS


A total of 139 adult participants with MDD and insomnia disorder were treated with antidepressant medication and randomized to receive 7 sessions of CBT-I or a control therapy (CTRL). Circadian preference (eveningness) was measured using the Composite Scale of Morningness (CSM). Depression symptom severity was assessed using the Hamilton Depression Rating Scale (HDRS); insomnia symptom severity was assessed using the Insomnia Severity Inventory (ISI). The moderating role of circadian preference on changes in HRSD and ISI was assessed via latent growth models within the framework of structural equation modeling.
RESULTS


Greater evening preference was associated with smaller reduction in HDRS ( P  = .03) from baseline to week 6 across treatment groups. The interaction between CSM and treatment group was also significant ( P  = .02), indicating that participants with greater evening preference in the CTRL group had significantly smaller HDRS reduction than those with greater evening preference in the CBT-I group. Circadian preference did not share significant associations with ISI (all  P  > .30).
CONCLUSIONS


Individuals with MDD and insomnia who have an evening preference are at increased risk for poor response to pharmacological depression treatment augmented with either CBT-I or CTRL behavioral insomnia treatment. However, evening types have better depression outcomes when treated with CBT-I than with CTRL for insomnia.",2019,"RESULTS


Greater evening preference was associated with smaller reduction in HDRS ( P  = .03) from baseline to week 6 across treatment groups.","['Insomnia Plus Antidepressant Medications', '139 adult participants with MDD and insomnia disorder', 'patients with major depressive disorder (MDD) and insomnia']","['CBT-I or a control therapy (CTRL', 'Cognitive Behavioral Therapy', 'antidepressant medication', 'antidepressant medication plus cognitive behavioral therapy']","['Circadian preference (eveningness', 'Hamilton Depression Rating Scale (HDRS); insomnia symptom severity', 'Circadian preference', 'Composite Scale of Morningness (CSM', 'depression and insomnia symptom severity', 'HDRS', 'HDRS reduction', 'Insomnia Severity Inventory (ISI', 'Depression symptom severity', 'depression outcomes']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",139.0,0.0391897,"RESULTS


Greater evening preference was associated with smaller reduction in HDRS ( P  = .03) from baseline to week 6 across treatment groups.","[{'ForeName': 'Lauren D', 'Initials': 'LD', 'LastName': 'Asarnow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Bei', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Krystal', 'Affiliation': 'School of Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manber', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7716']
231,30952217,Effects of an Acute Bout of Light-Intensity Walking on Sleep in Older Women With Sleep Impairment: A Randomized Controlled Trial.,"STUDY OBJECTIVES


This study aimed to explore the effects of a single bout of light-intensity walking on sleep in older women with mild sleep impairment.
METHODS


A total of 40 women aged 55 years or older with mild sleep impairment were randomized to either a treadmill walking session for 50 minutes or a quiet-rest control. All participants completed the study (mean age: 60.4 ± 4.7 years). Sleep quality was assessed by ActiGraph for 2 nights before (pretest) and 2 nights after exercise (posttest). A mixed-design analysis of variance was used with group as the between-subjects factor and time point as the within-subjects factor.
RESULTS


No significant group difference in demographic variables, body mass index, physical and mental status, and eight sleep parameters were observed at baseline. Significant group-time interactions existed for sleep latency ( P  < .001) and sleep efficiency ( P  = .025). After the intervention, the walking group reduced sleep latency by 3.3 minutes ( P  = .001) and also had greater sleep efficiency (increase 3.8%,  P  = .008), but no significant change was found in the control group. No significant group-time interactions were present for the other six sleep parameters (activity counts, total sleep time, wake after sleep onset, number and length of awakenings, or time in bed).
CONCLUSIONS


A single session of light-intensity walking led to a modest reduction in sleep latency and improvement of sleep efficiency in older women with mild sleep impairment.",2019,"After the intervention, the walking group reduced sleep latency by 3.3 minutes ( P  = .001) and also had greater sleep efficiency (increase 3.8%,  P  = .008), but no significant change was found in the control group.","['40 women aged 55 years or older with mild sleep impairment', 'older women with mild sleep impairment', 'All participants completed the study (mean age: 60.4 ± 4.7 years', 'Older Women With Sleep Impairment']","['treadmill walking session for 50 minutes or a quiet-rest control', 'single bout of light-intensity walking', 'light-intensity walking', 'Acute Bout of Light-Intensity Walking']","['six sleep parameters (activity counts, total sleep time, wake after sleep onset, number and length of awakenings, or time in bed', 'sleep efficiency', 'Sleep quality', 'demographic variables, body mass index, physical and mental status, and eight sleep parameters', 'sleep latency']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}]",40.0,0.0566135,"After the intervention, the walking group reduced sleep latency by 3.3 minutes ( P  = .001) and also had greater sleep efficiency (increase 3.8%,  P  = .008), but no significant change was found in the control group.","[{'ForeName': 'Li-Jung', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise Health Science, and Graduate Institute of Recreational Sport Management, National Taiwan University of Sport, Taiwan.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Stevinson', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, United Kingdom.'}, {'ForeName': 'Shih-Hua', 'Initials': 'SH', 'LastName': 'Fang', 'Affiliation': 'Institute of Athletics, National Taiwan University of Sport, Taiwan.'}, {'ForeName': 'Chih-Yang', 'Initials': 'CY', 'LastName': 'Taun', 'Affiliation': 'Department of Exercise Health Science, National Taiwan University of Sport, Taiwan.'}, {'ForeName': 'Po-Wen', 'Initials': 'PW', 'LastName': 'Ku', 'Affiliation': 'Graduate Institute of Sports and Health, National Changhua University of Education, Taiwan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7718']
232,31663690,Effects of serum from breast cancer surgery patients receiving perioperative dexmedetomidine on breast cancer cell malignancy: A prospective randomized controlled trial.,"Adrenergic receptors (ARs) have gained attention for their involvement in breast cancer (BC) progression. Dexmedetomidine, a selective α 2  -AR agonist, has been reported to increase the malignancy of BC cells in vitro or stimulate tumor growth in mice. However, clinical evidence is lacking. Clinical research in this area is important as dexmedetomidine is widely used in BC surgery patients. Here we allocated 24 women with primary BC to the dexmedetomidine group (who received a total dose of 2 μg kg -1  dexmedetomidine perioperatively) or to the control group (who received the same volume of normal saline). Venous blood was obtained from all patients immediately upon entering the operating room and 24 hours postoperatively. Serum was then exposed to MCF-7 cells at a concentration of 10% for 24 hours. Cell proliferation, migration, and invasion were analyzed using EdU, Transwell, and Matrigel methods, respectively. We found that postoperative serum from those who received dexmedetomidine was associated with significantly increased cell proliferation, migration, and invasion compared with preoperative serum when used to culture MCF-7 cells. The mean percentage change from post to preoperative values in these cell functions was significantly larger in the dexmedetomidine group than in the control group (proliferation, 30.44% vs 8.45%, P = .0024; migration, 15.90% vs 3.25%, P = .0015; invasion, 8.17% vs 2.13%, P = .04). In conclusion, these findings suggest that in patients undergoing surgery for primary BC, perioperative administration of dexmedetomidine might influence the serum milieu in a way that favors the malignancy of MCF-7 cells. Clinical trial registration: NCT03108937.",2019,"We found that postoperative serum from those who received dexmedetomidine was associated with significantly increased cell proliferation, migration, and invasion compared with preoperative serum when used to culture MCF-7 cells.","['breast cancer surgery patients receiving', '24 women with primary BC to the', 'BC surgery patients', 'breast cancer cell malignancy', 'patients undergoing surgery for primary BC']","['dexmedetomidine', 'total dose of 2\xa0μg\xa0kg -1  dexmedetomidine perioperatively) or to the control group (who received the same volume of normal saline', 'Dexmedetomidine', 'perioperative dexmedetomidine', 'Adrenergic receptors (ARs']","['cell proliferation, migration, and invasion', 'Venous blood', 'Cell proliferation, migration, and invasion']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}]","[{'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}]",24.0,0.0717347,"We found that postoperative serum from those who received dexmedetomidine was associated with significantly increased cell proliferation, migration, and invasion compared with preoperative serum when used to culture MCF-7 cells.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China.'}, {'ForeName': 'Yueyao', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Breast, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Diansan', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Breast, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Cancer medicine,['10.1002/cam4.2654']
233,31916533,A randomized controlled trial of respiratory physiotherapy in lower respiratory tract infections.,"INTRODUCTION


Physiotherapy may play a role in the recovery of signs, symptoms and function of patients with lower respiratory tract infections (LRTI) but its effectiveness is still controversial.
OBJECTIVES


To assess the effects of respiratory physiotherapy compared with standard pharmacological care on symptoms and function in outpatients with LRTI.
DESIGN


Single-blind, randomised controlled trial.
SETTING


Outpatients were recruited from the casualties of a central hospital.
PARTICIPANTS


Outpatients with LRTI were recruited and randomly allocated to the control (pharmacological) or experimental (pharmacological and respiratory physiotherapy) group.
INTERVENTION


The intervention consisted of conventional pharmacological treatment and conventional pharmacological treatment plus respiratory physiotherapy. Respiratory physiotherapy included breathing and airway clearance techniques, exercise training and education during 3-weeks, 3 times per week.
MAIN OUTCOME MEASURE


Primary outcome measures - occupation rate of wheezes Wh%; Secondary outcome measures - number of crackles, peripheral oxygen saturation (SpO2) modified Borg scale (mBorg), modified Medical Research Council scale (mMRC), 6-min walk test (6MWT), forced expiratory volume in 1 s and forced vital capacity, and volume and density of the lung and bronchial tree volume.
RESULTS


Ninety-seven patients (53 controls and 44 experimental) completed the intervention. After the intervention, both groups improved significantly in all variables (0.0001 < p < 0.04; 0.001<ƞ 2 <0.092), with the exception of the mBorg. The magnitude of improvement of the experimental group exceeded the control group in the number of crackles, SpO2 levels, mMRC and 6MWT (0.002 < p < 0.032; 0.002<ƞ 2 <0.092).
CONCLUSION


Adding respiratory physiotherapy to the pharmacological treatment of outpatients with LRTI results in greater recovery of symptoms and function parameters.
TRIAL REGISTRATION


NCT02053870.",2020,"The magnitude of improvement of the experimental group exceeded the control group in the number of crackles, SpO2 levels, mMRC and 6MWT (","['patients with lower respiratory tract infections (LRTI', 'Outpatients with LRTI', 'Outpatients were recruited from the casualties of a central hospital', 'Ninety-seven patients (53 controls and 44 experimental) completed the intervention', 'lower respiratory tract infections', 'outpatients with LRTI']","['conventional pharmacological treatment and conventional pharmacological treatment plus respiratory physiotherapy', 'respiratory physiotherapy', 'Physiotherapy', 'Respiratory physiotherapy included breathing and airway clearance techniques, exercise training and education during 3-weeks, 3 times per week', 'control (pharmacological) or experimental (pharmacological and respiratory physiotherapy', 'standard pharmacological care']","[' occupation rate of wheezes Wh%; Secondary outcome measures - number of crackles, peripheral oxygen saturation (SpO2) modified Borg scale (mBorg), modified Medical Research Council scale (mMRC), 6-min walk test (6MWT), forced expiratory volume in 1\xa0s and forced vital capacity, and volume and density of the lung and bronchial tree volume', 'number of crackles, SpO2 levels, mMRC and 6MWT ', 'recovery of symptoms and function parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest (regime/therapy)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0040811', 'cui_str': 'Trees'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",97.0,0.0723729,"The magnitude of improvement of the experimental group exceeded the control group in the number of crackles, SpO2 levels, mMRC and 6MWT (","[{'ForeName': 'Alda', 'Initials': 'A', 'LastName': 'Marques', 'Affiliation': 'School of Health Sciences, University of Aveiro (ESSUA), Aveiro, Portugal; Lab 3R - Respiratory Research and Rehabilitation Laboratory, School of Health Sciences, University of Aveiro (ESSUA), Aveiro, Portugal; Institute of Biomedicine (iBiMED), Department of Medical Sciences, University of Aveiro, Aveiro, Portugal. Electronic address: amarques@ua.pt.'}, {'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Pinho', 'Affiliation': 'Instituto de Telecomunicações (IT) and Department of Electronics, Telecommunications and Informatics (DETI), University of Aveiro, 3810-193, Aveiro, Portugal. Electronic address: catiap@ua.pt.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Francesco', 'Affiliation': 'School of Health Sciences, University of Aveiro (ESSUA), Aveiro, Portugal; Institute of Electronics and Informatics Engineering of Aveiro (IEETA), University of Aveiro, Aveiro, Portugal. Electronic address: silvia.francesco@ua.pt.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Martins', 'Affiliation': 'School of Health Sciences, University of Aveiro (ESSUA), Aveiro, Portugal; Institute of Biomedicine (iBiMED), Department of Medical Sciences, University of Aveiro, Aveiro, Portugal; Institute of Electronics and Informatics Engineering of Aveiro (IEETA), University of Aveiro, Aveiro, Portugal. Electronic address: pmartins@ua.pt.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Neves', 'Affiliation': 'Centro Hospital Do Baixo Vouga, Internal Medicine Department, Aveiro, Portugal. Electronic address: joana.brrneves@gmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oliveira', 'Affiliation': 'School of Health Sciences, University of Aveiro (ESSUA), Aveiro, Portugal; Lab 3R - Respiratory Research and Rehabilitation Laboratory, School of Health Sciences, University of Aveiro (ESSUA), Aveiro, Portugal; Institute of Biomedicine (iBiMED), Department of Medical Sciences, University of Aveiro, Aveiro, Portugal. Electronic address: alao@ua.pt.'}]",Respiratory medicine,['10.1016/j.rmed.2019.105861']
234,32252062,"Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.","A single, subanesthetic dose of (R,S)-ketamine (ketamine) exerts rapid and robust antidepressant effects. Several groups previously reported that (2S,6S;2R,6R)-hydroxynorketamine (HNK) had antidepressant effects in rodents, and that (2R,6R)-HNK increased cortical electroencephalographic gamma power. This exploratory study examined the relationship between ketamine metabolites, clinical response, psychotomimetic symptoms, and gamma power changes in 34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a single ketamine infusion (0.5 mg/kg) over 40 min. Plasma concentrations of ketamine, norketamine, and HNKs were measured at 40, 80, 120, and 230 min and at 1, 2, and 3 days post-infusion. Linear mixed models evaluated ketamine metabolites as mediators of antidepressant and psychotomimetic effects and their relationship to resting-state whole-brain magnetoencephalography (MEG) gamma power 6-9 h post-infusion. Three salient findings emerged. First, ketamine concentration positively predicted distal antidepressant response at Day 11 post-infusion, and an inverse relationship was observed between (2S,6S;2R,6R)-HNK concentration and antidepressant response at 3 and 7 days post-infusion. Norketamine concentration was not associated with antidepressant response. Second, ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations at 40 min were positively associated with contemporaneous psychotomimetic symptoms; post-hoc analysis revealed that ketamine was the predominant contributor. Third, increased (2S,6S;2R,6R)-HNK maximum observed concentration (C max ) was associated with increased MEG gamma power. While contrary to preclinical observations and our a priori hypotheses, these exploratory results replicate those of a recently published study documenting a relationship between higher (2S,6S;2R,6R)-HNK concentrations and weaker antidepressant response in humans and provide further rationale for studying gamma power changes as potential biomarkers of antidepressant response.",2020,Norketamine concentration was not associated with antidepressant response.,['34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a'],"['placebo', 'ketamine', 'subanesthetic dose of (R,S)-ketamine (ketamine', '2S,6S;2R,6R)-hydroxynorketamine (HNK', 'Ketamine', 'single ketamine infusion']","['Plasma concentrations of ketamine, norketamine, and HNKs', '2S,6S;2R,6R)-HNK concentration and antidepressant response', 'ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations', 'distal antidepressant response', 'Norketamine concentration', 'cortical electroencephalographic gamma power']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0410552,Norketamine concentration was not associated with antidepressant response.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0663-6']
235,31588607,Improving fitness increases dentate gyrus/CA3 volume in the hippocampal head and enhances memory in young adults.,"Converging evidence suggests a relationship between aerobic exercise and hippocampal neuroplasticity that interactively impacts hippocampally dependent memory. The majority of human studies have focused on the potential for exercise to reduce brain atrophy and attenuate cognitive decline in older adults, whereas animal studies often center on exercise-induced neurogenesis and hippocampal plasticity in the dentate gyrus (DG) of young adult animals. In the present study, initially sedentary young adults (18-35 years) participated in a moderate-intensity randomized controlled exercise intervention trial (ClinicalTrials.gov; NCT02057354) for a duration of 12 weeks. The aims of the study were to investigate the relationship between change in cardiorespiratory fitness (CRF) as determined by estimated  V   ˙   O   2     MAX  , hippocampally dependent mnemonic discrimination, and change in hippocampal subfield volume. Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults. Consistent with previous studies that found exercise-induced increases in anterior hippocampus in older adults, this result was specific to the hippocampal head, or most anterior portion, of the subregion. Our results also demonstrate a positive relationship between change in CRF and change in corrected accuracy for trials requiring the highest level of discrimination on a putative behavioral pattern separation task. This relationship was observed in individuals who were initially lower-fit, suggesting that individuals who show greater improvement in their CRF may receive greater cognitive benefit. This work extends animal models by providing evidence for exercise-induced neuroplasticity specific to the neurogenic zone of the human hippocampus.",2020,Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults.,"['young adults', 'older adults', 'initially sedentary young adults (18-35\u2009years) participated in a moderate-intensity randomized']",['controlled exercise intervention'],"['anterior hippocampus', 'cardiorespiratory fitness (CRF']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]",,0.0561769,Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults.,"[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nauer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Dunne', 'Affiliation': 'Center for Systems Neuroscience, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Chantal E', 'Initials': 'CE', 'LastName': 'Stern', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schon', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}]",Hippocampus,['10.1002/hipo.23166']
236,31972694,Improved Complex Skill Acquisition by Immersive Virtual Reality Training: A Randomized Controlled Trial.,"BACKGROUND


There has been limited literature on immersive virtual reality (VR) simulation in orthopaedic education. The purpose of this multicenter, blinded, randomized controlled trial was to determine the validity and efficacy of immersive VR training in orthopaedic resident education.
METHODS


Nineteen senior orthopaedic residents (resident group) and 7 consultant shoulder arthroplasty surgeons (expert group) participated in the trial comparing immersive VR with traditional learning using a technical journal article as a control. The examined task focused on achieving optimal glenoid exposure. Participants completed demographic questionnaires, knowledge tests, and a glenoid exposure on fresh-frozen cadavers while being examined by blinded shoulder arthroplasty surgeons. Training superiority was determined by the outcome measures of the Objective Structured Assessment of Technical Skills (OSATS) score, a developed laboratory metric, verbal answers, and time to task completion.
RESULTS


Immersive VR had greater realism and was superior in teaching glenoid exposure than the control (p = 0.01). The expert group outperformed the resident group on knowledge testing (p = 0.04). The immersive VR group completed the learning activity and knowledge tests significantly faster (p < 0.001) at a mean time (and standard deviation) of 11 ± 3 minutes than the control group at 20 ± 4 minutes, performing 3 to 5 VR repeats for a reduction in learning time of 570%. The immersive VR group completed the glenoid exposure significantly faster (p = 0.04) at a mean time of 14 ± 7 minutes than the control group at 21 ± 6 minutes, with superior OSATS instrument handling scores (p = 0.03). The immersive VR group scored equivalently in surprise verbal scores (p = 0.85) and written knowledge scores (p = 1.0).
CONCLUSIONS


Immersive VR demonstrated substantially improved translational technical and nontechnical skills acquisition over traditional learning in senior orthopaedic residents. Additionally, the results demonstrate the face, content, construct, and transfer validity for immersive VR.
CLINICAL RELEVANCE


This adequately powered, randomized controlled trial demonstrated how an immersive VR system can efficiently (570%) teach a complex surgical procedure and also demonstrate improved translational skill and knowledge acquisition when compared with a traditional learning method.",2020,"The immersive VR group completed the glenoid exposure significantly faster (p = 0.04) at a mean time of 14 ± 7 minutes than the control group at 21 ± 6 minutes, with superior OSATS instrument handling scores (p = 0.03).","['Nineteen senior orthopaedic residents (resident group) and 7 consultant shoulder arthroplasty surgeons (expert group) participated in the trial comparing', 'senior orthopaedic residents']","['Immersive VR', 'Immersive Virtual Reality Training', 'immersive VR training', 'immersive VR with traditional learning using a technical journal article as a control']","['written knowledge scores', 'surprise verbal scores', 'translational technical and nontechnical skills acquisition', 'Objective Structured Assessment of Technical Skills (OSATS) score, a developed laboratory metric, verbal answers, and time to task completion', 'face, content, construct, and transfer validity for immersive VR', 'learning time', 'translational skill and knowledge acquisition']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0282420', 'cui_str': 'Journal Article'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}]",19.0,0.0278692,"The immersive VR group completed the glenoid exposure significantly faster (p = 0.04) at a mean time of 14 ± 7 minutes than the control group at 21 ± 6 minutes, with superior OSATS instrument handling scores (p = 0.03).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lohre', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Bois', 'Affiliation': 'Section of Orthopaedic Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Athwal', 'Affiliation': 'Roth McFarlane Hand and Upper Limb Center, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Danny P', 'Initials': 'DP', 'LastName': 'Goel', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00982']
237,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE


To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery.
METHODS


This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months.
OUTCOME MEASURE


Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done.
RESULTS


The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper.
CONCLUSIONS


IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8']
238,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES


This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS


Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
RESULTS


Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
CONCLUSIONS


Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z']
239,32294074,Assessing Gaze Patterns in Common Cosmetic Procedures With Eye-Tracking Technology.,"BACKGROUND


Understanding the salient features that draw focus when assessing aesthetics is important for maximizing perceived outcomes. Eye-tracking technology provides an unbiased method for determining the features that draw attention when evaluating aesthetic plastic surgery. This study aimed to characterize viewing patterns of plastic surgery patients and laypeople when assessing facial cosmetic procedure images.
METHODS


Twenty women who previously underwent cosmetic procedures and twenty women without a history of cosmetic procedures were shown sixteen pairs of preprocedure and postprocedure images of patients who underwent laser resurfacing or lip augmentation. Image pairs were randomized to whether preprocedural or postprocedural images came first. Participants viewed each image until they decided upon an aesthetic rating (scored 1-10), while an eye-tracking device recorded participants' gaze.
RESULTS


The patient group's average ratings were 8.2% higher for preprocedural images and 13.3% higher for postprocedural images (P < 0.05 for both). The patient group spent 20.4% less time viewing images but spent proportionally more time evaluating the relevant features of each procedure (41.7% vs 23.3%, P < 0.01), such as the vermillion border of the upper lip, labial commissure, or periorbital region (P < 0.05 for each). For both groups, the most common site of first fixation was the nose for laser resurfacing images (26.6%) and the labial commissure for lip augmentation images (37.7%). Both groups spent more time fixated on nasolabial folds, marionette lines, and the periorbital region when viewing pre-laser resurfacing images than postprocedural images. Overall, each group had similar viewing patterns for time to first fixation on and frequency of fixations for a particular feature.
CONCLUSIONS


Women who previously underwent cosmetic procedures view postprocedural images more favorably and require less time to assess images, likely related to familiarity with aesthetic procedures. These women spend more time fixated on relevant features, such as the vermillion border of the upper lip, the labial commissure, and the periorbital region, than the control group. Notably, each group spent less time focused on regions associated with wrinkles, such as the marionette and periorbital areas in post-laser resurfacing images, suggesting that the procedure reduces attention-drawing features in these areas.",2020,"Overall, each group had similar viewing patterns for time to first fixation on and frequency of fixations for a particular feature.
",['Twenty women who previously underwent cosmetic procedures and twenty women without a history of cosmetic procedures'],"['laser resurfacing or lip augmentation', 'plastic surgery patients and laypeople']","['time fixated on nasolabial folds, marionette lines, and the periorbital region', 'average ratings', 'labial commissure for lip augmentation images', 'time viewing images', 'vermillion border of the upper lip, labial commissure, or periorbital region']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4523976', 'cui_str': 'Lip augmentation'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0226924', 'cui_str': 'Commissure of lips'}, {'cui': 'C4523976', 'cui_str': 'Lip augmentation'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0226936', 'cui_str': 'Structure of vermilion border of upper lip'}]",20.0,0.0464945,"Overall, each group had similar viewing patterns for time to first fixation on and frequency of fixations for a particular feature.
","[{'ForeName': 'Dylan J', 'Initials': 'DJ', 'LastName': 'Peterson', 'Affiliation': 'From the Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Amee D', 'Initials': 'AD', 'LastName': 'Azad', 'Affiliation': 'From the Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Aikaterina', 'Initials': 'A', 'LastName': 'Gkorila', 'Affiliation': ""University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Ashraf A', 'Initials': 'AA', 'LastName': 'Patel', 'Affiliation': 'College of Medicine, SUNY Upstate Medical University, Syracuse, NY.'}, {'ForeName': 'Molly S', 'Initials': 'MS', 'LastName': 'Boudreault', 'Affiliation': 'Illuminate Plastic Surgery, Palo Alto, CA.'}, {'ForeName': 'Rahim S', 'Initials': 'RS', 'LastName': 'Nazerali', 'Affiliation': 'Division of Plastic & Reconstructive Surgery, Stanford University, Stanford, CA.'}]",Annals of plastic surgery,['10.1097/SAP.0000000000002387']
240,32294325,Does the method of administering fluids matter for contrast-induced nephropathy? REMEDIAL III compares LVEDP versus urine flow-guided hydration.,"Contrast-induced nephropathy (CIN) is a major cause of morbidity and mortality among patients undergoing angiographic procedures. Limiting contrast dose and administration of intravenous normal saline appear to be the best approaches to reducing CIN, but the timing, dose, and duration of optimal hydration is poorly understood. The REMEDIAL III trial protocol outlines two different targeted hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP), and 700 patients at high risk of CIN will be randomized.",2020,"The REMEDIAL III trial protocol outlines two different targeted hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP), and 700 patients at high risk of CIN will be randomized.","['700 patients at high risk of CIN', 'patients undergoing angiographic procedures']","['LVEDP versus urine flow-guided hydration', 'intravenous normal saline', 'hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP']",[],"[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0456190', 'cui_str': 'Left ventricular end-diastolic pressure'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2919339', 'cui_str': 'Measurement of urine output'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",[],,0.0288212,"The REMEDIAL III trial protocol outlines two different targeted hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP), and 700 patients at high risk of CIN will be randomized.","[{'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Grines', 'Affiliation': 'Northside Cardiovascular Institute, Atlanta, Georgia, USA.'}, {'ForeName': 'J Jeffrey', 'Initials': 'JJ', 'LastName': 'Marshall', 'Affiliation': 'Northside Cardiovascular Institute, Atlanta, Georgia, USA.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28879']
241,31891553,Prospective Randomized Comparison of Capsular Management Techniques During Hip Arthroscopy.,"BACKGROUND


Capsular management during hip arthroscopy remains controversial. Studies evaluating this topic consist mostly of retrospective comparative reviews of prospectively gathered data on a large series of patients.
PURPOSE/HYPOTHESIS


The purpose was to perform a prospective randomized trial to comparatively assess 3 commonly performed capsular management techniques. It was hypothesized that capsular closure during hip arthroscopy would result in superior outcomes when compared with unclosed capsulotomy management techniques.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


Patients (N = 150) who had hip arthroscopy with labral repairs and femoral osteoplasties performed by the senior author were randomly assigned into 3 groups at the time of their surgery: T-capsulotomy without closure (TC), interportal capsulotomy without closure (IC), and interportal capsulotomy with closure (CC). All patients underwent labral repair and femoral osteoplasty. Patient-reported outcomes were obtained preoperatively and at 3, 6, 12, and 24 months postoperatively. Other outcomes obtained included the need for future hip surgery.
RESULTS


Patient demographics, preoperative patient-reported outcomes, and radiographic measurements were similar among all 3 groups. Revision hip arthroscopy was performed in 5 TC cases, 2 IC cases, and 1 CC case ( P  = .17). Conversion to hip arthroplasty occurred in 4 patients in the TC group and none in the IC and CC groups ( P  = .02). The CC group showed higher modified Harris Hip Score (mHHS) and Hip Outcome Score-Activities of Daily Living (HOS-ADL) at the 2-year follow-up when compared with the IC group ( P  = .003 and  P  < .001, respectively). When compared with the TC group, the CC group demonstrated superior mHHS (86.2 vs 76), HOS-ADL (85.6 vs 76.8), and HOS-SSS (Hip Outcome Score-Sports-Specific Subscale; 74.4 vs 65.3) at the final 2-year follow-up ( P  < .001). At the 2-year follow-up, the IC group had a higher mHHS (81.7 vs 76), HOS-ADL (82 vs 76.8), and HOS-SSS (71.4 vs 65.3;  P  > .001) as compared with the TC group.
CONCLUSION


Patients undergoing complete capsular closure during hip arthroscopy showed improved patient-reported and surgical outcomes when compared with those with unrepaired T-capsulotomy or interportal capsulotomy. These results suggest that repair after capsulotomy may be a favorable arthroscopic capsular management technique.",2020,"When compared with the TC group, the CC group demonstrated superior mHHS (86.2 vs 76), HOS-ADL (85.6 vs 76.8), and HOS-SSS (Hip Outcome Score-Sports-Specific Subscale; 74.4 vs 65.3) at the final 2-year follow-up ( P  < .001).",['Patients (N = 150) who had hip arthroscopy with labral repairs and femoral osteoplasties performed by the senior author'],"['Capsular Management Techniques', 'surgery: T-capsulotomy without closure (TC), interportal capsulotomy without closure (IC), and interportal capsulotomy with closure (CC', 'labral repair and femoral osteoplasty', 'TC']","['superior mHHS', 'HOS-ADL', 'modified Harris Hip Score (mHHS) and Hip Outcome Score-Activities of Daily Living (HOS-ADL', 'patient-reported and surgical outcomes', 'radiographic measurements', 'Revision hip arthroscopy', 'HOS-SSS', 'Conversion to hip arthroplasty']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]",,0.0619913,"When compared with the TC group, the CC group demonstrated superior mHHS (86.2 vs 76), HOS-ADL (85.6 vs 76.8), and HOS-SSS (Hip Outcome Score-Sports-Specific Subscale; 74.4 vs 65.3) at the final 2-year follow-up ( P  < .001).","[{'ForeName': 'Kostas J', 'Initials': 'KJ', 'LastName': 'Economopoulos', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Arizona, Phoenix, Arizona, USA.'}, {'ForeName': 'Anikar', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic Arizona, Phoenix, Arizona, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kweon', 'Affiliation': 'Department of Orthopaedics, University of Washington, Seattle, Washington, USA.'}]",The American journal of sports medicine,['10.1177/0363546519894301']
242,30938035,"Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open-label, randomized-controlled FPG GOAL trial.","The optimal fasting blood glucose (FBG) target of achieving HbA1c less than 7.0% in type 2 diabetes (T2D) patients remains controversial. This open-label trial randomized (1:3:3) 947 adults with uncontrolled T2D (HbA1c >7% to ≤10.5%) who were using one to three oral antidiabetic drugs to achieve an FBG target of 3.9 < FBG ≤5.6 mmol/L (Group 1), 3.9 < FBG ≤6.1 mmol/L (Group 2) or of 3.9 < FBG ≤7.0 mmol/L (Group 3). Targets were achieved using a pre-defined insulin glargine 100 U/mL titration scheme. The primary endpoint was proportion of patients achieving HbA1c <7.0% at 24 weeks. At 24 weeks, 44.4%, 46.1% and 37.7% of patients achieved HbA1c <7.0% in Groups 1, 2 and 3, respectively (P = 0.017; Group 2 vs Group 3). Alert hypoglycaemia (glucose ≤3.9 mmol/L) was significantly more frequent in Group 1 than in Group 3 (38.9 vs 23.3%; P < 0.001) but was not in Group 2 vs Group 3 (27.5% vs 23.3%; P = 0.177). Clinically important hypoglycaemia (glucose ≤3.0 mmol/L) was reported in 4.8%, 2.0% and 3.8% of patients in Groups 1, 2 and 3, respectively. In conclusion, the optimal FBG target for most Chinese patients with T2D appears to be 3.9-6.1 mmol/L.",2019,Alert hypoglycaemia (glucose ≤3.9 mmol/L) was significantly more frequent in Group 1 than in Group 3 (38.9 vs 23.3%; P < 0.001) but was not in Group 2 vs Group 3 (27.5% vs 23.3%; P = 0.177).,"['patients with type 2 diabetes', '947 adults with uncontrolled T2D (HbA1c >7% to ≤10.5%) who were using one to three oral antidiabetic drugs to achieve an FBG target of 3.9\u2009<\u2009FBG ≤5.6 mmol/L (Group 1), 3.9\u2009<\u2009FBG ≤6.1 mmol/L (Group 2) or of 3.9\u2009<\u2009FBG\u2009≤7.0 mmol/L (Group 3']",[],"['Clinically important hypoglycaemia', 'optimal fasting blood glucose (FBG', 'proportion of patients achieving HbA1c', 'Alert hypoglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}]",[],"[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",947.0,0.0682074,Alert hypoglycaemia (glucose ≤3.9 mmol/L) was significantly more frequent in Group 1 than in Group 3 (38.9 vs 23.3%; P < 0.001) but was not in Group 2 vs Group 3 (27.5% vs 23.3%; P = 0.177).,"[{'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Endocrine Department, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Endocrine Department, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Guoyue', 'Initials': 'G', 'LastName': 'Yuan', 'Affiliation': 'Endocrine Department, Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Endocrine Department, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Endocrine Department, Qingpu Branch of Zhongshan Hospital, Affiliated with Fudan University, Shanghai, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Endocrine Department, The Second Affiliated Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': ""Endocrine Department, Changzhou Second People's Hospital, Affiliated with Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': ""Endocrine Department, Chenzhou No. 1 People's Hospital, Chenzhou, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Endocrine Department, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Endocrine Department, The Third Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Riqiu', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': ""Endocrine Department, Lishui People's Hospital, Lishui, China.""}, {'ForeName': 'Yunguang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Medical Department, Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Medical Department, Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Medical Department, Sanofi Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Jinkui', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Endocrine Department, Beijing Tongren Hospital, Beijing, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13733']
243,32145279,"Effects of Whole-Body Vibration Training on the Physical Function of the Frail Elderly: An Open, Randomized Controlled Trial.","OBJECTIVE


To investigate the feasibility and benefits of whole-body vibration (WBV) exercise as a safe and effective training tool for countering sarcopenia and age-related declines in mobility and function in the frail elderly.
DESIGN


An open, randomized controlled trial.
SETTING


Residential care facilities.
PARTICIPANTS


Male and female volunteers (N=117; 82.5±7.9y).
INTERVENTIONS


After prescreening for contraindications, participants were randomly allocated to a control, simulated WBV (SIM), or WBV exercise group. All participants received regular care, whereas WBV and SIM participants also underwent thrice-weekly exercise sessions for 16 weeks. Delivered by overload principle, WBV training began with 5 × 1-minute bouts at 6 Hz/2 mm (1:1 min exercise:rest), progressing to 10 × 1 minute at up to 26 Hz/4 mm, maintaining knee flexion. Training for SIM participants mimicked WBV exercise stance and duration only.
MAIN OUTCOME MEASURES


The timed Up and Go, Parallel Walk, and 10-m Timed Walk (10mTW) tests performance were assessed, in addition to the Barthel Index Questionnaire, at baseline, 8, and 16 weeks of exercise, and 3, 6, and 12 months postexercise.
RESULTS


High levels of compliance were reported in SIM (89%) and WBV training (93%), with ease of use and no adverse effects. In comparison to baseline levels, WBV training elicited clinically important treatment effects in all parameters compared to SIM and control groups. Treatment effects remained apparent up to 12 months postintervention for Parallel Walk Test and 6 months for 10mTW Test. Functional test performance declined during and postintervention in non-WBV groups.
CONCLUSIONS


Findings indicate that 16 weeks of low-level WBV exercise provides easily accessible, adequate stimulus for the frail elderly to attain improved levels of physical functionality.",2020,Treatment-effects remained apparent up-to 12-months post-intervention for Parallel Walk and 6-months for 10-m Timed-Walk.,['Residential care-facilities PARTICIPANTS: 117 male and female volunteers (82.5 ± 7.9 years'],"['Control (CON), Simulated-WBV (SIM) or WBV-exercise (WBV) group', 'Whole Body Vibration (WBV) exercise', 'regular care, whilst WBV- and SIM- participants also underwent thrice-weekly exercise sessions']","['WBV-exercise stance', 'Timed-Up-and-Go, Parallel Walk and 10-m Timed-Walk test performance']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",117.0,0.0407411,Treatment-effects remained apparent up-to 12-months post-intervention for Parallel Walk and 6-months for 10-m Timed-Walk.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wadsworth', 'Affiliation': 'School of Sport & Exercise, Massey University, New Zealand; School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Australia. Electronic address: dwadswor@usc.edu.au.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lark', 'Affiliation': 'Sport and Exercise New Zealand, Christchurch, New Zealand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.009']
244,31758610,UCC118 supplementation reduces exercise-induced gastrointestinal permeability and remodels the gut microbiome in healthy humans.,"Dysregulation of gut microbiota and intestinal barrier function has emerged as potential mechanisms underlying digestive diseases, yet targeted therapies are lacking The purpose of this investigation was to assess the efficacy of UCC118, a characterized probiotic strain, on exercise-induced GI permeability in healthy humans. In a randomized, double-blind, placebo-controlled crossover study, seven healthy adults received 4 weeks of daily UCC118 or placebo supplementation. GI hyperpermeability was induced by strenuous treadmill running performed before and after each supplementation period. While running, participants ingested 5 g of lactulose, rhamnose, and sucrose. Urine was collected before, immediately after, and every hour for 5 h after exercise to assess GI permeability. Metagenomic sequencing was performed on fecal homogenates collected prior to exercise to identify changes in microbial diversity and taxon abundances. Inflammatory biomarkers were assessed from blood and fecal homogenates collected prior to and immediately following the cessation of exercise. Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001). UCC118 significantly reduced sucrose (Δ = -0.38 ± 0.13 vs. 1.69 ± 0.79; P < 0.05) recovery, with no substantial change in lactulose (Δ = -0.07 ± 0.23 vs. 0.35 ± 0.15; P = 0.16) or rhamnose (Δ = -0.06 ± 0.22 vs. 0.48 ± 0.28; P = 0.22). Taxonomic sequencing revealed 99 differentially regulated bacteria spanning 6 taxonomic ranks (P < 0.05) after UCC118 supplementation. No differences in plasma IL-6 or fecal zonulin were observed after UCC118 supplementation. The results described herein provide proof of principle that 4 weeks of UCC118 supplementation attenuated exercise-induced intestinal hyperpermeability. Further research is warranted to investigate the as-yet-to-be defined molecular processes of intestinal hyperpermeability and the effects of probiotic supplementation.",2019,"Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001).","['seven healthy adults', 'healthy humans']","['placebo', 'UCC118 supplementation', 'UCC118 or placebo supplementation']","['Inflammatory biomarkers', 'intestinal hyperpermeability', 'GI hyperpermeability', 'plasma IL-6 or fecal zonulin', 'intestinal permeability of lactulose, rhamnose, and sucrose']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0035417', 'cui_str': 'rhamnose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]",,0.200239,"Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001).","[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Connery J', 'Initials': 'CJ', 'LastName': 'Brennan', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Cresci', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hull', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Ciarán E', 'Initials': 'CE', 'LastName': 'Fealy', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}]",Physiological reports,['10.14814/phy2.14276']
245,32056676,Long-term effects of web-based pedometer-mediated intervention on COPD exacerbations.,"BACKGROUND


Technology-based physical activity (PA) interventions have been shown to improve daily step counts and health-related quality of life, but their effect on long-term clinical outcomes like acute exacerbations (AEs) is unknown in persons with COPD.
METHODS


U.S. Veterans with stable COPD were randomized (1:1) to either pedometer alone (control) or pedometer plus a website with feedback, goal-setting, disease education, and a community forum (intervention) for 3 months. AEs were assessed every 3 months over a follow-up period of approximately 15 months. Pedometer-assessed daily step counts, health-related quality-of-life (HRQL), and self-efficacy were assessed at baseline, end-of-intervention at 3 months, and during follow-up approximately 6 and 12 months after enrollment. Zero-inflated Poisson models assessed the effect of the intervention on risk for AEs, compared to controls. Generalized linear mixed-effects models for repeated measures examined between-group and within-group changes in daily step count, HRQL, and self-efficacy.
RESULTS


There were no significant differences in age, FEV 1 % predicted, baseline daily step count, AEs the year prior to enrollment, or duration of follow-up between the intervention (n = 57) and control (n = 52) groups. The intervention group had a significantly reduced risk of AEs (rate ratio = 0.51, [95%CI 0.31-0.85]), compared to the control group. There were no significant between-group differences in change in average daily step count, HRQL, or self-efficacy at 6 and 12 months after enrollment.
CONCLUSIONS


A 3-month internet-mediated, pedometer-based PA intervention was associated with reduced risk for AEs of COPD over 12-15 months of follow-up. ClinicalTrials.gov identifier: NCT01772082.",2020,"There were no significant between-group differences in change in average daily step count, HRQL, or self-efficacy at 6 and 12 months after enrollment.
","['U.S. Veterans with stable COPD', 'persons with COPD']","['Technology-based physical activity (PA) interventions', 'pedometer alone (control) or pedometer plus a website with feedback, goal-setting, disease education, and a community forum (intervention', 'web-based pedometer-mediated intervention']","['daily step count, HRQL, and self-efficacy', 'average daily step count, HRQL, or self-efficacy', 'Pedometer-assessed daily step counts, health-related quality-of-life (HRQL), and self-efficacy', 'COPD exacerbations', 'reduced risk for AEs of COPD', 'risk of AEs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]",57.0,0.125038,"There were no significant between-group differences in change in average daily step count, HRQL, or self-efficacy at 6 and 12 months after enrollment.
","[{'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Wan', 'Affiliation': ""Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Channing Division of Network Medicine, Brigham & Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kantorowski', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Kadri', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gagnon', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA; Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Garshick', 'Affiliation': ""Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Channing Division of Network Medicine, Brigham & Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, VA Boston Healthcare System, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: marilyn.moy@va.gov.'}]",Respiratory medicine,['10.1016/j.rmed.2020.105878']
246,31703120,Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Chronic kidney disease (CKD) is a common complication of type 2 diabetes that can lead to end-stage kidney disease and is associated with high cardiovascular risk. Few treatments are available to prevent CKD in type 2 diabetes.
Objective


To test whether supplementation with vitamin D3 or omega-3 fatty acids prevents development or progression of CKD in type 2 diabetes.
Design, Setting, and Participants


Randomized clinical trial with a 2 × 2 factorial design conducted among 1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial (VITAL), coordinated by a single center in Massachusetts. Follow-up was completed in December 2017.
Interventions


Participants were randomized to receive vitamin D3 (2000 IU/d) and omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid; 1 g/d) (n = 370), vitamin D3 and placebo (n = 333), placebo and omega-3 fatty acids (n = 289), or 2 placebos (n = 320) for 5 years.
Main Outcomes and Measures


The primary outcome was change in glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR) from baseline to year 5.
Results


Among 1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study. Baseline mean eGFR was 85.8 (SD, 22.1) mL/min/1.73 m2. Mean change in eGFR from baseline to year 5 was -12.3 (95% CI, -13.4 to -11.2) mL/min/1.73 m2 with vitamin D3 vs -13.1 (95% CI, -14.2 to -11.9) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.5] mL/min/1.73 m2). Mean change in eGFR was -12.2 (95% CI, -13.3 to -11.1) mL/min/1.73 m2 with omega-3 fatty acids vs -13.1 (95% CI, -14.2 to -12.0) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.6] mL/min/1.73 m2). There was no significant interaction between the 2 interventions. Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
Conclusions and Relevance


Among adults with type 2 diabetes, supplementation with vitamin D3 or omega-3 fatty acids, compared with placebo, resulted in no significant difference in change in eGFR at 5 years. The findings do not support the use of vitamin D or omega-3 fatty acid supplementation for preserving kidney function in patients with type 2 diabetes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01684722.",2019,"Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
","['1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study', 'adults with type 2 diabetes', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes', 'Importance\n\n\nChronic kidney disease (CKD', '1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial']","['Vitamin D and Omega-3 Fatty Acid Supplementation', 'omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid', 'vitamin D3 and placebo', 'omega-3 fatty acids and n\u2009=\u200917 receiving placebo', 'vitamin D3 or omega-3 fatty acids', ' mL', 'placebo', 'mL', 'vitamin D3', 'placebo and omega-3 fatty acids (n\u2009=\u2009289), or 2 placebos', 'omega-3 fatty acids', 'vitamin D or omega-3 fatty acid supplementation']","['Kidney stones', 'gastrointestinal bleeding', 'Mean change in eGFR', 'Baseline mean eGFR', 'Kidney Function', 'change in eGFR', 'glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR', 'kidney function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}]",1312.0,0.488501,"Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
","[{'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ruzinski', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Duszlak', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vadim Y', 'Initials': 'VY', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Thadhani', 'Affiliation': 'Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2019.17380']
247,28922935,"Stereotype threat, trait perseveration, and vagal activity: evidence for mechanisms underpinning health disparities in Black Americans.","Objective:  Black Americans (BAs) are at an elevated risk for morbidity and mortality in comparison to White Americans (WAs). Racial stressors are a common occurrence in American culture and is theorized to contribute to these disparities. When race-focused, stereotype threat (ST) is considered to be a factor that is detrimental to health in BAs; however few studies have directly investigated the impact of a ST manipulation on physiological function. Furthermore, it is proposed that racial stressors such as ST may have prolonged effects when more likely to perseverate (e.g. rumination) over the stressor and thus, those with greater trait perseveration may be more affected by ST. We sought to explore the impact of ST and trait perseveration on changes in vagus nerve activity - an indication of adaptive psychological and physiological well-being - as indexed by vagally mediated heart rate variability (vmHRV).  Design:  Forty-three (24 females, mean age of 20, standard deviation of 3 years) apparently healthy BA individuals were randomly assigned to one of three experimental conditions in which they received either implicit (subtle), explicit (blatant), or no ST priming (control condition), prior to completing a cognitive task. Resting vmHRV was assessed both at baseline (pre-task) and recovery (post-task).  Results:  BAs in the explicit ST condition exhibited the greatest decrease in vmHRV in comparison to the control group from pre- to post-task. BAs with moderate to high levels of trait perseveration showed the greatest decrease in vmHRV from pre- to post-task in comparison to those with lower levels of trait perseveration and BAs in the control group.  Conclusion:  These data suggest that racial ST, especially when explicit and coupled with trait perseveration, can decrease vagal activity, as indexed by decreased vmHRV, which when experienced frequently can have significant consequences for health and longevity in BAs.",2019,"RESULTS


BAs in the explicit ST condition exhibited the greatest decrease in vmHRV in comparison to the control group from pre- to post-task.","['Forty-three (24 females, mean age of 20, standard deviation of 3 years) apparently healthy BA individuals', 'Black Americans (BAs', 'Black Americans']","['implicit (subtle), explicit (blatant), or no ST priming (control condition), prior to completing a cognitive task']","['Resting vmHRV', 'vagal activity', 'vmHRV']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0254408,"RESULTS


BAs in the explicit ST condition exhibited the greatest decrease in vmHRV in comparison to the control group from pre- to post-task.","[{'ForeName': 'DeWayne P', 'Initials': 'DP', 'LastName': 'Williams', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'LaBarron K', 'Initials': 'LK', 'LastName': 'Hill', 'Affiliation': 'Center for the Study of Aging and Human Development, Duke University Medical Center , Durham , NC , USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Sollers', 'Affiliation': 'Department of Psychology, North Carolina Central University , Durham , NC , USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Vasey', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Baldwin M', 'Initials': 'BM', 'LastName': 'Way', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Koenig', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Julian F', 'Initials': 'JF', 'LastName': 'Thayer', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus , OH , USA.'}]",Ethnicity & health,['10.1080/13557858.2017.1378803']
248,29124951,"The role of serious mental illness in motivation, participation and adoption of health behavior change among obese/sedentary Latino adults.","Objective:  Serious mental illness (SMI; e.g. schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, severe major depressive disorder, and psychotic disorders) and Latino ethnicity can produce a compounded health disparity, placing individuals at particularly high risk for excess morbidity and premature mortality. In this study we sought to identify the role of SMI in motivation, participation, and adoption of health behavior change among overweight Latino adults.  Design:  Qualitative, semi-structured interviews were conducted with 20 overweight Latinos with SMI who were enrolled in a randomized trial evaluating the effectiveness of a motivational health promotion intervention adapted for persons with SMI, In SHAPE. The interviews explored the complicated role having an SMI had in the lives of the Latino participants.  Results:  SMI had both positive and negative impact on Latino participants' health behaviors. The nature of their mental illness along with medication side effects (e.g. lethargy, weight gain, etc.) negatively impacted their ability to making lasting health behavior change. However, the regular appointments with various specialists provided them with structure that they otherwise would have lacked and gave them a reason to get out of the house.  Conclusions:  This exploratory research provides insight into the experience of overweight Latinos with SMI and the ways in which SMI impacts their participation in health behavior change. An understanding of the positive and negative effects of SMI on health behavior change will inform the development of health promotion interventions targeted at Latinos with SMI.",2019,An understanding of the positive and negative effects of SMI on health behavior change will inform the development of health promotion interventions targeted at Latinos with SMI.,"['obese/sedentary Latino adults', 'persons with SMI, In SHAPE', 'overweight Latino adults', '20 overweight Latinos with SMI who were enrolled']",['motivational health promotion intervention'],"[""Latino participants' health behaviors""]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0018687'}]",20.0,0.0307663,An understanding of the positive and negative effects of SMI on health behavior change will inform the development of health promotion interventions targeted at Latinos with SMI.,"[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Jimenez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine , Miami , FL , USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Veterams Affairs Medical Center Miami , Miami , FL , USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bartels', 'Affiliation': 'Dartmouth Centers for Health and Aging, Geisel School of Medicine at Dartmouth , Hanover , NH , USA.'}]",Ethnicity & health,['10.1080/13557858.2017.1390552']
249,32284080,"A social robot intervention on depression, loneliness, and quality of life for Taiwanese older adults in long-term care.","OBJECTIVES


To investigate the effect of a social robot intervention on depression, loneliness, and quality of life of older adults in long-term care (LTC) and to explore participants' experiences and perceptions after the intervention.
DESIGN


A mixed-methods approach consisting of a single group, before and after quasi-experimental design, and individual interview.
PARTICIPANTS


Twenty older adults with depression from four LTC facilities in Taiwan were recruited.
INTERVENTION


Each participant participated in 8 weeks of observation and 8 weeks of intervention. In the observation stage, participants received usual care or activities without any research intervention. In the intervention stage, each participant was given a Paro (Personal Assistive RobOt) to keep for 24 hours, 7 days a week.
MEASUREMENTS


The Geriatric Depression Scale, the UCLA Loneliness Scale Version 3, and the World Health Organization Quality of Life Questionnaire for older adults were administered at four time points. Individual qualitative interviews with thematic analysis followed.
RESULTS


A repeated multivariate analysis of variance and Friedman's test showed no significant changes during the observation stage between T1 and T2 for depression and quality of life (p >.5). For the intervention stage, statistically significant changes in decreasing depression and loneliness and improving quality of life over time were identified. Three themes emerged from the interviews: (i) humanizing Paro through referring to personal experiences and engagement; (ii) increased social interaction with other people; and (iii) companionship resulting in improved mental well-being.
CONCLUSIONS


There were significant improvements in mental well-being in using Paro. Further research may help us to understand the advantages of using a Paro intervention as depression therapy.",2020,"For the intervention stage, statistically significant changes in decreasing depression and loneliness and improving quality of life over time were identified.","['Twenty older adults with depression from four LTC facilities in Taiwan were recruited', 'older adults', 'Taiwanese older adults in long-term care']","['social robot intervention', 'humanizing Paro through referring to personal experiences and engagement; (ii) increased social interaction with other people; and (iii) companionship resulting in improved mental well-being', 'usual care or activities without any research intervention']","['Geriatric Depression Scale, the UCLA Loneliness Scale Version 3, and the World Health Organization Quality of Life Questionnaire', 'depression, loneliness, and quality of life', 'depression and quality of life', 'depression and loneliness and improving quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",20.0,0.0195205,"For the intervention stage, statistically significant changes in decreasing depression and loneliness and improving quality of life over time were identified.","[{'ForeName': 'Shu-Chuan', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moyle', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Petsky', 'Affiliation': 'School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.'}]",International psychogeriatrics,['10.1017/S1041610220000459']
250,32169459,Aquatic Cycling Improves Knee Pain and Physical Functioning in Patients With Knee Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE


To assess the efficacy of a 12-week aquatic cycling training program for improving knee pain and physical functioning in patients with knee osteoarthritis (OA).
DESIGN


Two-arm, single-blind, parallel-group randomized controlled trial.
SETTINGS


OA outpatient clinic of the Maastricht University Medical Center+.
PARTICIPANTS


Patients (N=111, 50-70y) with unilateral mild-to-moderate knee OA.
INTERVENTIONS


Participants (aquatic cycling [AC] group, n=55) received AC sessions of 45 min each 2 times per week. Each session combined upright seated cycling with out-of-saddle positions and exercises for the upper and lower body. The usual care (UC) group (n=47) continued with UC and was offered 12 AC sessions in a local swimming pool after their trial participation.
MAIN OUTCOME MEASURES


The Knee Injury and Osteoarthritis Outcome Score (KOOS) on knee pain and physical function was assessed at baseline, postintervention, and at 24-wk follow-up. Multilevel (mixed regression) analysis examined the effects.
RESULTS


Average attendance rate for the AC sessions was 80%. Statistically significant differences at postintervention and follow-up were found for knee pain in mean ± SD (UC pretest, 57.89±15.26; posttest, 55.90±18.04; follow-up, 57.24±19.16; and AC pretest, 56.96±12.96; posttest, 63.55±15.33; follow-up, 64.35±17.26; estimate, 8.16; SE, 3.27; 95% confidence interval [CI], 1.67-14.64; effect size [ES], 0.50) and physical functioning (UC pretest, 66.32±16.28; posttest, 66.80±19.04; follow-up, 65.42±17.98; and AC pretest, 61.89±17.151; posttest, 70.14±17.52; follow-up, 69.00±16.84; estimate, 7.16; SE, 3.19; 95% CI, 0.83-13.49; ES, 0.43) in favor of the aquatic group.
CONCLUSIONS


The results suggest that a 12-week AC training program improves self-reported knee pain and physical functioning in patients with mild-to-moderate knee OA compared to UC.",2020,The results suggest that a 12-week aquatic cycling training programme improves self-reported knee pain and physical functioning in patients with mild to moderate knee OA compared to usual care.,"['patients with mild to moderate knee OA', 'Patients (N=111, 50-70 years old) with unilateral mild to moderate knee OA', 'OA outpatient clinic of the Maastricht University Medical Center', 'patients with knee osteoarthritis']","['aquatic cycling training programme', 'Aquatic cycling', 'aquatic cycling training program', 'aquatic cycling sessions of 45 min twice-weekly', 'usual care group (UC, n=47) continued with usual care and was offered twelve aquatic cycling sessions']","['physical functioning', 'Average attendance rate', 'knee pain', 'knee pain and physical functioning', 'self-reported knee pain and physical functioning', 'Knee Injury and Osteoarthritis Outcome Score (KOOS) on knee pain and physical function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0525992,The results suggest that a 12-week aquatic cycling training programme improves self-reported knee pain and physical functioning in patients with mild to moderate knee OA compared to usual care.,"[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Rewald', 'Affiliation': 'Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'A F Ton', 'Initials': 'AFT', 'LastName': 'Lenssen', 'Affiliation': 'Department of Physiotherapy, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Emans', 'Affiliation': 'Department of Orthopedic Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'de Bie', 'Affiliation': 'Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Breukelen', 'Affiliation': 'Department of Methodology & Statistics, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Mesters', 'Affiliation': 'Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands. Electronic address: ilse.mesters@maastrichtuniversity.nl.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.023']
251,32237292,"Metabolic Effects of 7 Antipsychotics on Patients With Schizophrenia: A Short-Term, Randomized, Open-Label, Multicenter, Pharmacologic Trial.","OBJECTIVE


To compare longitudinal metabolic effects of 7 antipsychotics, including body mass index (BMI), waist circumference (WC), blood pressure (BP), glucose, triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C); to investigate risk factors for metabolic syndrome (MetS); and to make recommendations on frequency and timing of monitoring metabolic measurements.
METHODS


This randomized, open-label, pharmacologic trial was conducted among patients with schizophrenia (DSM-IV) in 32 hospitals across China. Patients were randomly assigned to 7 groups and assessed at baseline, 2, 4, and 6 weeks. Linear mixed-effect models were used to assess changes of metabolic measures over time. Multivariable logistic regression analysis was performed to investigate the risk factors for MetS.
RESULTS


In total, 2,550 (718 drug-naïve) of 2,774 patients finished the study between July 6, 2010, and November 30, 2011. We found significant (P < .05) changes for BMI, WC, TG, and LDL-C, with TG and LDL-C reaching a plateau. Interactions between baseline metabolic condition and changes over time were observed for BMI (χ² = 43.11, P < .001), WC (χ² = 36.34, P < .001), systolic BP (χ² = 11.92, P = .002), glucose (χ² = 6.09, P = .01), and TG (χ² = 6.01, P = .01). Antipsychotics generally had greater adverse effects on patients who were initially screened as metabolically normal. After controlling for other associated factors, we found that antipsychotics resulted in differing risk for incident MetS, with a similar pattern to findings in other populations: olanzapine (odds ratio [OR] = 3.36, P < .001) > quetiapine (OR = 3.29, P < .001) > perphenazine (OR = 2.73, P = .007) > risperidone (OR = 2.21, P = .02) > aripiprazole (OR = 1.74, P = .15) ≈ haloperidol (OR = 1.75, P = .22) ≈ ziprasidone (OR = 1, reference).
CONCLUSIONS


Metabolic traits should be monitored frequently in early stages of antipsychotic treatment due to rapid and substantial changes. Clinicians should not assume low risk for patients with normal metabolic parameters at baseline.
TRIAL REGISTRATION


Chinese Clinical Trial Registry identifier: ChiCTR-TRC-10000934.",2020,"risperidone (OR = 2.21, P = .02)","['Patients With Schizophrenia', 'In total, 2,550 (718 drug-naïve) of 2,774 patients finished the study between July 6, 2010, and November 30, 2011', 'patients with schizophrenia (DSM-IV) in 32 hospitals across China', 'patients who were initially screened as metabolically normal']","['Antipsychotics', 'risperidone', 'haloperidol', 'perphenazine', 'ziprasidone', 'quetiapine', 'olanzapine', 'aripiprazole']","['systolic BP', 'adverse effects', 'metabolic syndrome (MetS', 'BMI, WC, TG, and LDL-C, with TG and LDL-C reaching a plateau', 'body mass index (BMI), waist circumference (WC), blood pressure (BP), glucose, triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0031184', 'cui_str': 'Perphenazine'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",2774.0,0.0759597,"risperidone (OR = 2.21, P = .02)","[{'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Gavin P', 'Initials': 'GP', 'LastName': 'Reynolds', 'Affiliation': 'Biomolecular Science Research Centre, Sheffield Hallam University, Sheffield, United Kingdom.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Yue', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), Beijing, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Second Xiangya Hospital, Central South University, Hunan, China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Beijing Anding Hospital, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guigang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Beijing, China.'}, {'ForeName': 'Tianlan', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), Beijing, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), Beijing, China.'}, {'ForeName': 'Fuquan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Wuxi Mental Health Center, Nanjing Medical University, Wuxi, Jiangshu, China.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Institute of Mental Health, Tianjin Anding Hospital, Tianjin, China.'}, {'ForeName': 'Keqing', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Hebei Mental Health Center, Baoding, Hebei, China.'}, {'ForeName': 'Luxian', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China.'}, {'ForeName': 'Qingrong', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, Xi'an, Shanxi, China.""}, {'ForeName': 'Yinfei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Beijing Anding Hospital, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Beijing, China.'}, {'ForeName': 'Lingjiang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Second Xiangya Hospital, Central South University, Hunan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Liansheng', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Huiyao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Wanjun', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Huaxi Biobank, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Coid', 'Affiliation': 'Mental Health Center and Psychiatric Laboratory, The State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': '#28 Dianxin South St, Chengdu 610041, Sichuan, China. litaohx@scu.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12785']
252,32081599,Comparison of the efficacy and safety of melatonin and memantine in the alleviation of cognitive impairments induced by electroconvulsive therapy: A randomized clinical trial.,"The purpose of this study was to assess and compare the efficacy and safety of melatonin and memantine in the alleviation of cognitive disorders in patients diagnosed with major depressive disorder (MDD) undergoing electroconvulsive therapy (ECT). Patients undergoing ECT for treatment of MDD were randomly allocated to the melatonin (3 mg/d) or memantine (5 mg/d) groups. The participants received either melatonin or memantine (tablet) through the ECT therapy, which was started at beginning the first day of ECT and continued to the sixth session. The Modified Mental State Examination (MMSE) was used to evaluate cognitive function before and after the intervention. Frothy eligible patients (22 females and 18 males) were studied. There was no significant difference between two groups in terms of demographic characteristics, hemodynamic parameters and baseline MMSE and item 3 MMSE. The Memantine group scored significantly higher at the end of the ECT sessions either by MMSE or item 3MMSE than the baseline (P = 0.04 and P = 0.03, respectively). In the melatonin group, both MMSE and item 3MMSE scores were decreased significantly than the baseline (p = 0.03 and p = 0.02, respectively). No withdrawal was observed due to the drugs' adverse effects. It seems that memantine (5 mg/d) is more effective than melatonin (3 mg/d), to alleviate cognitive disorders induced by ECT.",2020,"There was no significant difference between two groups in terms of demographic characteristics, hemodynamic parameters and baseline MMSE and item 3 MMSE.","['patients diagnosed with major depressive disorder (MDD) undergoing electroconvulsive therapy (ECT', 'Frothy eligible patients (22 females and 18 males', 'Patients undergoing ECT for treatment of MDD']","['melatonin', 'memantine', 'melatonin and memantine', 'melatonin or memantine (tablet) through the ECT therapy', 'Memantine', 'Modified Mental State Examination (MMSE', 'electroconvulsive therapy']","['MMSE and item 3MMSE scores', 'demographic characteristics, hemodynamic parameters and baseline MMSE and item 3 MMSE', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0440906,"There was no significant difference between two groups in terms of demographic characteristics, hemodynamic parameters and baseline MMSE and item 3 MMSE.","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Sarraf', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Taleb', 'Initials': 'T', 'LastName': 'Badri', 'Affiliation': 'Neuroscience Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Keshvari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ayfar', 'Initials': 'A', 'LastName': 'Ghassab-Sahebkar', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Roja', 'Initials': 'R', 'LastName': 'Qobadighadikolaei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abbasinazari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m_abbasi@sbmu.ac.ir.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.02.011']
253,31562796,Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.,"BACKGROUND


In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC.
METHODS


In this open-label, phase 3 trial, we randomly assigned patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus ipilimumab as compared with chemotherapy in patients with a PD-L1 expression level of 1% or more.
RESULTS


Among the patients with a PD-L1 expression level of 1% or more, the median duration of overall survival was 17.1 months (95% confidence interval [CI], 15.0 to 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI, 12.7 to 16.7) with chemotherapy (P = 0.007), with 2-year overall survival rates of 40.0% and 32.8%, respectively. The median duration of response was 23.2 months with nivolumab plus ipilimumab and 6.2 months with chemotherapy. The overall survival benefit was also observed in patients with a PD-L1 expression level of less than 1%, with a median duration of 17.2 months (95% CI, 12.8 to 22.0) with nivolumab plus ipilimumab and 12.2 months (95% CI, 9.2 to 14.3) with chemotherapy. Among all the patients in the trial, the median duration of overall survival was 17.1 months (95% CI, 15.2 to 19.9) with nivolumab plus ipilimumab and 13.9 months (95% CI, 12.2 to 15.1) with chemotherapy. The percentage of patients with grade 3 or 4 treatment-related adverse events in the overall population was 32.8% with nivolumab plus ipilimumab and 36.0% with chemotherapy.
CONCLUSIONS


First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC, independent of the PD-L1 expression level. No new safety concerns emerged with longer follow-up. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 227 ClinicalTrials.gov number, NCT02477826.).",2019,"CONCLUSIONS


First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC, independent of the PD-L1 expression level.","['patients who had a PD-L1 expression level of less than 1', 'Advanced Non-Small-Cell Lung Cancer', 'patients with NSCLC', 'patients with advanced non-small-cell lung cancer (NSCLC']","['nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone', 'nivolumab plus ipilimumab, nivolumab alone, or chemotherapy', 'Nivolumab plus Ipilimumab', 'nivolumab plus ipilimumab']","['adverse events', 'median duration of response', 'overall survival benefit', 'PD-L1 expression level', 'overall survival', 'median duration of overall survival', '2-year overall survival rates', 'longer duration of overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}]",,0.260969,"CONCLUSIONS


First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC, independent of the PD-L1 expression level.","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Hellmann', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Reyes', 'Initials': 'R', 'LastName': 'Bernabe Caro', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Zurawski', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Carcereny Costa', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Alexandru', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Lupinacci', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'de la Mora Jimenez', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Albert', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vergnenegre', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Brahmer', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': ""O'Byrne"", 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Geese', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Prabhu', 'Initials': 'P', 'LastName': 'Bhagavatheeswaran', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Sridhar K', 'Initials': 'SK', 'LastName': 'Rabindran', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Ravi S', 'Initials': 'RS', 'LastName': 'Kasinathan', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Nathan', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'From the Memorial Sloan Kettering Cancer Center, New York (M.D.H.); Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas, Universidad Complutense, and Centro de Investigación Biomédica en Red de Cáncer, Madrid (L.P.-A.), Hospital Universitario Virgen Del Rocio, Seville (R.B.C.), and the Catalan Institute of Oncology-Germans Trias i Pujol Hospital, Badalona (E.C.C.) - all in Spain; Ambulatorium Chemioterapii, Bydgoszcz, Poland (B.Z.); the Asan Medical Center (S.-W.K.) and the Samsung Medical Center at Sungkyunkwan University School of Medicine (K.P.) - both in Seoul, South Korea; the Institute of Oncology Prof. Dr. Alexandru Trestioreanu, Bucharest, Romania (A.A.); the Hospital Italiano de Buenos Aires, Buenos Aires (L.L.); Instituto Jalisciense de Cancerologia, Guadalajara, Mexico (E.M.J.); the Saitama Cancer Center, Saitama, Japan (H.S.); Matrai Gyogyintezet, Matrahaza, Hungary (I.A.); Limoges University Hospital, Limoges (A.V.), and Aix-Marseille University, National Center for Scientific Research, INSERM, Centre de Recherche en Cancérologie de Marseille, Assistance Publique-Hôpitaux de Marseille, Marseille (F.B.) - all in France; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland (S.P.); Sotiria General Hospital, National and Kapodistrian University of Athens, Athens (K.S.); Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany (M.R.); Fox Chase Cancer Center, Philadelphia (H.B.); Johns Hopkins Kimmel Cancer Center, Baltimore (J.R.B.); Princess Alexandra Hospital, Brisbane, QLD, Australia (K.J.O.); Bristol-Myers Squibb, Princeton, NJ (W.J.G., P.B., S.K.R., R.S.K., F.E.N.); and Winship Cancer Institute, Emory University, Atlanta (S.S.R.).'}]",The New England journal of medicine,['10.1056/NEJMoa1910231']
254,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE


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


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


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


Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
255,32145277,Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Exploratory Single-Blinded Randomized Controlled Trial.,"OBJECTIVE


To compare the effects of unilateral and bilateral arm training on arm impairment in severely affected patients with stroke.
DESIGN


Single-blinded, randomized controlled trial.
SETTING


Inpatient rehabilitation center.
PARTICIPANTS


First-time subacute patients (N=69) with stroke and a nonfunctional hand. Patients were stratified according to lesion location post hoc.
INTERVENTIONS


Repetitive bilateral arm training on an arm cycle followed by synchronized bilateral repetitive distal hand training or an identical unilateral arm training performed by the paretic limb only. Both unilateral and bilateral trainings were administered twice daily over 6 weeks.
MAIN OUTCOME MEASURES


The primary outcome measure was the Fugl-Meyer Assessment (FMA) score for the arm, and secondary measures were biomechanical parameters measuring isometric force and rate of force generation. Outcome measures were assessed before, at the end of, and 2 weeks after intervention.
RESULTS


Patients were homogeneous at study onset. All patients improved regarding the FMA arm score and most biomechanical parameters after intervention. Yet the post hoc analysis stratifying patients according to lesion location showed that patients with pure subcortical stroke, but not patients with cortical involvement of stroke, showed a significantly greater improvement (P=.022) following the bilateral training in FMA arm score (from 6.8±5.7 to 17.8±15.8) compared with unilateral training (from 6.5±7.8 to 8.7±8.6).
CONCLUSIONS


The benefit of bilateral arm training followed by repetitive bilateral hand training for motor control of the severely paretic upper limb may depend on lesion location. Further studies with larger sample size are required for the validation of these results.",2020,All patients improved regarding the FMA and most biomechanical parameters after intervention.,"['severely affected stroke patients', 'Severely Affected Stroke Patients', 'Inpatient rehabilitation center', 'Sixty-nine first time subacute patients with stroke and a non-functional hand', 'Patients were homogeneous at study onset']","['Bilateral Arm Training versus unilateral Arm Training', 'Repetitive bilateral arm training on an ""arm-cycle"" followed by synchronized bilateral repetitive distal hand training, or an identical unilateral arm training performed by the paretic limb only', 'unilateral and bilateral arm training', 'repetitive bilateral hand training']","['Fugl-Meyer Score for the arm (FMA), and secondary measures were biomechanical parameters measuring isometric force and rate of force generation']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0205300', 'cui_str': 'Non-functional (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]",,0.160241,All patients improved regarding the FMA and most biomechanical parameters after intervention.,"[{'ForeName': 'Caroline I E', 'Initials': 'CIE', 'LastName': 'Renner', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany. Electronic address: c.c.renner@t-online.de.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Brendel', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Hummelsheim', 'Affiliation': 'NRZ Neurological Rehabilitation Center, University of Leipzig, Leipzig, Germany.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.007']
256,32145280,Effects of High-Intensity Interval Training After Stroke (the HIIT-Stroke Study): A Multicenter Randomized Controlled Trial.,"OBJECTIVE


To examine if 8 weeks of high-intensity interval training (HIIT) in addition to standard care would increase and maintain peak oxygen uptake (Vo 2peak ) more than standard care alone in patients with stroke.
DESIGN


This was a single-blind, multicenter, parallel group, randomized controlled trial.
SETTING


Specialized rehabilitation units at 3 Norwegian hospitals.
PARTICIPANTS


Participants (N=70), 3 months to 5 years after first-ever stroke, were randomly assigned to the intervention group (n=36) or the control group (n=34); 42% were women, mean age was 57.6±9.3 years, mean time post stroke was 26.4±14.5 months.
INTERVENTION


The intervention was 8 weeks: 3 times a week with HIIT treadmill training with work periods of 4 × 4 minutes at 85%-95% of peak heart rate interspersed with 3 minutes of active recovery at 50%-70% of peak heart rate. The control group received standard care according to national guidelines.
OUTCOMES


The primary outcome, analyzed by intention-to-treat, was Vo 2peak  measured as liters per minute 12 months after inclusion. Secondary outcome measures were blood pressure and blood profile.
RESULTS


Mean baseline Vo 2peak  was 2.63±1.08 L·min -1  vs 2.87±0.71 L·min -1 , while at 12 months Vo 2peak  was 2.70±1.00 L·min -1  vs 2.67±0.76 L·min -1  (P=.068) in the intervention and control groups, respectively. There was a significant and greater improvement in the intervention group compared with the control group at 12 months in 3 of 6 secondary outcomes from the peak test but no significant differences for blood pressure or blood profile.
CONCLUSIONS


The HIIT intervention, which was well-tolerated in this sample of well-functioning survivors of stroke, was not superior to standard care in improving and maintaining Vo 2peak  at the 12-month follow-up. However, secondary results from the peak test showed a significant improvement from before to immediately after the intervention.",2020,"There was a significant and greater improvement in the intervention group compared to the control group at 12 months in three out of six secondary outcomes from the peak test, but no significant differences for the blood pressure or blood profile.
","['n=34), 42% women, mean (SD) age was 57.6 (9.3) years and 26.4 (14.5) months post-stroke', 'Participants, three months to five years after first-ever stroke', 'Specialized rehabilitation units at three Norwegian hospitals', 'patients with stroke']","['control group', 'standard care according to national guidelines', 'high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['blood pressure or blood profile', 'blood pressure and blood profile', 'Mean (SD) baseline VO 2peak', 'maintain peak oxygen uptake (VO 2peak ', 'intention-to-treat, was VO 2peak  measured as liters per minute']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005768'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0702093', 'cui_str': '/min'}]",,0.153526,"There was a significant and greater improvement in the intervention group compared to the control group at 12 months in three out of six secondary outcomes from the peak test, but no significant differences for the blood pressure or blood profile.
","[{'ForeName': 'Tor Ivar', 'Initials': 'TI', 'LastName': 'Gjellesvik', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Physical Medicine and Rehabilitation, St Olav's University Hospital, Trondheim, Norway. Electronic address: tor.i.gjellesvik@ntnu.no.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Faculty of Medicine, Oslo, Norway.'}, {'ForeName': 'Arnt Erik', 'Initials': 'AE', 'LastName': 'Tjønna', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; NeXt Move, NTNU, Trondheim, Norway.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Indredavik', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Stroke Unit, Department of Internal Medicine, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Halvard', 'Initials': 'H', 'LastName': 'Nilsen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ålesund Hospital, Ålesund, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Brurok', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, St Olav's University Hospital, Trondheim, Norway; Centre for Elite Sports Research, Department of Neuromedicine and Movement Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Tørhaug', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Physical Medicine and Rehabilitation, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Busuladzic', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Torunn', 'Initials': 'T', 'LastName': 'Askim', 'Affiliation': ""Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Stroke Unit, Department of Internal Medicine, St Olav's University Hospital, Trondheim, Norway.""}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.006']
257,32282432,Subcutaneous Nitroglycerin for Radial Arterial Catheterization in Pediatric Patients: A Randomized Controlled Trial.,"BACKGROUND


Pediatric radial artery cannulation is challenging because of the small vessel size. Nitroglycerin is a potent vasodilator and facilitates radial artery cannulation by increasing the internal diameter and preventing the vasospasm in adult patients. The authors hypothesize that subcutaneous nitroglycerin injection will improve the success rate of pediatric radial artery cannulation.
METHODS


This double-blind, randomized, controlled, single-center study enrolled pediatric patients (n = 113, age less than 2 yr) requiring radial artery cannulation during general anesthesia. The participants were randomized into the nitroglycerin group (n = 57) or control group (n = 56). After inducing general anesthesia, nitroglycerin solution (5 μg/kg in 0.5 ml), or normal saline (0.5 ml) was subcutaneously injected above the chosen radial artery over 10 s with ultrasound guidance. Three minutes later, the ultrasound-guided radial artery cannulation was performed. Radial artery diameter was measured before and after the subcutaneous injection and after cannulation. The primary outcome was the first-attempt successful cannulation rate. The secondary outcomes included the diameter of the radial artery and the overall complication rate including hematoma and vasospasm.
RESULTS


A total of 113 children were included in the analysis. The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%). Subcutaneous nitroglycerin injection increased the diameter of the radial artery greater than normal saline (25.0 ± 19.5% vs. 1.9 ± 13.1%; 95% CI of mean difference, 16.9 to 29.3%; P < 0.001). Overall complication rate was lower in the nitroglycerin group than in the control group (3.5% [2 of 57] vs. 31.2% [18 of 56]; P = 0.001; odds ratio, 0.077; 95% CI, 0.017 to 0.350; absolute risk reduction, 28.6%; 95% CI, 15.5 to 41.8%).
CONCLUSIONS


Subcutaneous nitroglycerin injection before radial artery cannulation improved the first-attempt success rate and reduced the overall complication rates in pediatric patients.",2020,"The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%).","['Pediatric Patients', 'enrolled pediatric patients (n = 113, age less than 2 yr) requiring radial artery cannulation during general anesthesia', '113 children', 'pediatric patients', 'adult patients']","['Subcutaneous Nitroglycerin', 'nitroglycerin', 'Subcutaneous nitroglycerin', 'normal saline', 'Nitroglycerin', 'nitroglycerin injection', 'nitroglycerin solution']","['success rate of arterial cannulation', 'Radial artery diameter', 'diameter of the radial artery and the overall complication rate including hematoma and vasospasm', 'diameter of the radial artery', 'first-attempt successful cannulation rate', 'higher first-attempt success rate', 'Overall complication rate', 'overall complication rates']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4307250', 'cui_str': 'Nitroglycerin Injection'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205250', 'cui_str': 'High'}]",113.0,0.634855,"The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%).","[{'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ""From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea (Y.-E.J., S.-H.J., E.-H.K., J.-H.L.) the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea (H.-S.K., J.-T.K.) the Division of Pediatric Cardiovascular Anesthesia, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas (E.B.M.).""}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Emad B', 'Initials': 'EB', 'LastName': 'Mossad', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003308']
258,32268896,A trial-based economic evaluation of the Restore4Stroke self-management intervention compared to an education-based intervention for stroke patients and their partners.,"BACKGROUND


Since stroke survivors are increasingly responsible for managing stroke-related changes in their own health and lifestyle, self-management skills are required. In a recent randomised controlled trial a self-management intervention based on proactive coping action planning (SMI) in comparison with an education-based intervention (EDU) in stroke patients was investigated. However, no relevant treatment effects on the Utrecht Proactive Coping Competence scale (UPCC) and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-Participation) were found. The current study is a trial-based economic evaluation from a societal perspective comparing the same interventions (SMI versus EDU).
METHODS


UPCC, USER-Participation and EuroQol (EQ-5D-3 L) and costs were measured at baseline, three, six and twelve months after treatment. For the cost-effectiveness analyses, incremental cost effectiveness ratios (ICERs) were calculated for UPCC and USER-Participation. For the cost-utility analyses the incremental cost utility ratio (ICUR) was expressed in cost per Quality Adjusted Life Years (QALYs). Outcomes were tested by means of AN(C)OVA analyses and costs differences by means of bootstrapping. Bootstrapping, sensitivity analyses and a subgroup analysis were performed to test the robustness of the findings.
RESULTS


One hundred thirteen stroke patients were included in this study. The mean differences in USER-Participation scores (95%CI:-13.08,-1.61, p-value = .013) were significant different between the two groups, this does not account for UPCC scores (95%CI:-.267, .113, p-value = not significant) and QALYs (p-value = not significant) at 12 months. The average total societal costs were not significantly different (95%CI:€-3380,€7099) for SMI (€17,333) in comparison with EDU (€15,520). Cost-effectiveness analyses showed a mean ICER of 26,514 for the UPCC and 346 for the USER-Participation. Cost-utility analysis resulted in an ICUR of €44,688 per QALY. Assuming a willingness to pay (WTP) threshold of €50,000 per QALY, the probability that SMI will be cost-effective is 52%. Sensitivity analyses and subgroup analysis showed the robustness of the results.
CONCLUSIONS


SMI is probably not a cost-effective alternative in comparison with EDU. Based on the current results, the value of implementing SMI for a stroke population is debatable. We recommend further exploration of the potential cost-effectiveness of stroke-specific self-management interventions focusing on different underlying mechanisms and using different control treatments.",2020,"The average total societal costs were not significantly different (95%CI:€-3380,€7099) for SMI (€17,333) in comparison with EDU (€15,520).","['One hundred thirteen stroke patients', 'stroke patients and their partners', 'stroke patients']","['education-based intervention (EDU', 'EuroQol', 'education-based intervention', 'proactive coping action planning (SMI', 'Restore4Stroke self-management intervention']","['EQ-5D-3\u2009L) and costs', 'average total societal costs', 'Utrecht Proactive Coping Competence scale (UPCC) and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-Participation', 'UPCC scores', 'USER-Participation scores', 'incremental cost utility ratio (ICUR', 'cost-effectiveness analyses, incremental cost effectiveness ratios (ICERs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0059804', 'cui_str': 'ethylene diurea'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0544297,"The average total societal costs were not significantly different (95%CI:€-3380,€7099) for SMI (€17,333) in comparison with EDU (€15,520).","[{'ForeName': 'Ghislaine A P G', 'Initials': 'GAPG', 'LastName': 'van Mastrigt', 'Affiliation': 'CAPHRI, School for Public Health and Primary Care, Department of Health Services Research, Faculty of Health, Medicine and Life Sciences, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. g.vanmastrigt@maastrichtuniversity.nl.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'van Eeden', 'Affiliation': 'CAPHRI, School for Public Health and Primary Care, Department of Health Services Research, Faculty of Health, Medicine and Life Sciences, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'van Heugten', 'Affiliation': 'MHeNS, School for Mental Health and Neuroscience; Department of Psychiatry and Neuropsychology, Faculty of Health, Medicine and Life Sciences Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Tielemans', 'Affiliation': 'MHeNS, School for Mental Health and Neuroscience; Department of Psychiatry and Neuropsychology, Faculty of Health, Medicine and Life Sciences Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Vera P M', 'Initials': 'VPM', 'LastName': 'Schepers', 'Affiliation': 'Center of Excellence in Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht, and De Hoogstraat Rehabilitation, Utrecht, The Netherlands.'}, {'ForeName': 'Silvia M A A', 'Initials': 'SMAA', 'LastName': 'Evers', 'Affiliation': 'CAPHRI, School for Public Health and Primary Care, Department of Health Services Research, Faculty of Health, Medicine and Life Sciences, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}]",BMC health services research,['10.1186/s12913-020-05103-x']
259,32283048,An Innovative STRoke Interactive Virtual thErapy (STRIVE) Online Platform for Community-Dwelling Stroke Survivors: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the STRoke Interactive Virtual thErapy (STRIVE) intervention on upper-extremity clinical outcomes in community-dwelling stroke survivors.
DESIGN


Assessor-blinded randomized controlled trial.
SETTING


Study screening and testing was conducted in a university clinic. Participants completed the virtual therapy (VT) intervention in a community-based stroke support group setting.
PARTICIPANTS


Of 124 stroke survivors initially assessed, 60 participants were recruited (time poststroke, 13.4±8.9 y). Participants were allocated to either VT or control group using a block randomization design and were stratified by sex.
INTERVENTIONS


Participants were randomized to receive 8 weeks of VT or usual care. The intervention consisted of approximately 45 minutes of twice weekly VT training on the Jintronix Rehabilitation System.
MAIN OUTCOME MEASURES


Between-group differences in the Fugl-Meyer Upper Extremity scale and Action Research Arm Test score were joint primary outcomes in this study.
RESULTS


Significant between-group differences for the Fugl-Meyer Upper Extremity scale were seen at the end of the intervention (F 1, 1 =5.37, P=.02, d=0.41). No significant differences were observed with the Action Research Arm Test. No adverse events were reported.
CONCLUSIONS


We demonstrated clinically meaningful improvements in gross upper extremity motor function and use of the affected arm after a VT intervention delivered via a community-based stroke support group setting. This data adds to the contexts in which VT can be used to improve upper limb function. Use of VT in community-based rehabilitation in chronic stroke recovery is supported.",2020,"RESULTS


Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","['community-dwelling stroke survivors', 'Study screening and testing was conducted in a University clinic', 'Of 124 stroke survivors initially assessed, 60 participants were recruited (time post-stroke 13.4 ± 8.9 years']","['virtual therapy (VT) intervention in a community-based stroke support group setting', 'VT training', 'VT intervention delivered via a community-based stroke support group setting', 'VT', 'STRoke Interactive Virtual thErapy (STRIVE) intervention', 'VT or usual care', 'innovative STRoke Interactive Virtual thErapy (STRIVE) online platform']","['1) Fugl-Meyer Upper Extremity scale, and 2) Action Research Arm Test score', 'Fugl-Meyer Upper Extremity scale', 'adverse events']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0902791,"RESULTS


Significant between group differences for the Fugl-Meyer Upper Extremity scale was seen at the end of the intervention (F 1, 1 =5.37, P = 0.02, d = 0.41).","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Australia; Faculty of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia; National Health and Medical Research Council Stroke Rehabilitation and Brain Recovery Centre of Research Excellence, The Florey Institute of Neuroscience and Mental Health, Melbourne, Australia.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Bird', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Launceston, Australia; Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Makii', 'Initials': 'M', 'LastName': 'Muthalib', 'Affiliation': 'Silverline Research, Brisbane, Australia; EuroMov, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia; Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore. Electronic address: weipeng.teo@nie.edu.sg.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.011']
260,31770329,Effect of Tracheal Intubation Mode on Cuff Pressure During Retractor Splay and Dysphonia Recovery After Anterior Cervical Spine Surgery: A Randomized Clinical Trial.,"MINI: This randomized clinical trial showed different intubation mode in anesthesia did not affect the increase of endotracheal cuff pressure caused by the retractor splay in anterior cervical spine surgery. However, nasotracheal intubation improved postoperative dysphonia recovery after anterior cervical spine surgery.
STUDY DESIGN


Prospective, randomized, double-blinded trial.
OBJECTIVE


The aim of this study was to investigate whether the mode of tracheal intubation affects intraoperative endotracheal tube cuff pressure on retractor splay and post-anterior cervical spine surgery (ACSS) voice outcome.
SUMMARY OF BACKGROUND DATA


The combination of endotracheal tube (ETT) and cervical retractors has been implicated in recurrent laryngeal nerve compression and neuropraxia after ACSS. The asymmetric position of the oroETT within the larynx, as being fixed distally by the cuff and proximally by taping on one side of the mouth, may contribute to unilateral vocal palsy.
METHODS


Adult patients undergoing ACSS were randomized to receive either nasotracheal or orotracheal intubation under anesthesia. The primary endpoint was the maximal endotracheal tube cuff pressure (ETCP) when the retractors were set up. After the maximal ETCPs were recorded, then ETCPs were controlled to less than 25 mmHg. Secondary endpoints were self-assessed hoarseness, pitch, and loudness of voice on postoperative days (PODs) 1, 2, 7, and 30.
RESULTS


We equally allocated 110 patients to nasotracheal and orotracheal intubation. The maximal ETCP during retractor splay did not differ for both the means and distributions of pressure range. After the surgery, more patients in the nasotracheal intubation group reported none or mild change of voice than did the orotracheal intubation group on PODs 1 and 2, in terms of hoarseness, pitch, and loudness (P = 0.001, 0.001, and 0.005, respectively, on POD 1; P = 0.002, 0.003, and 0.011, respectively, on POD 2). Mixed model analysis demonstrated that patients with nasotracheal intubation had significantly lower dysphonia scores after surgery (estimate treatment effect: -1.62, P < 0.0001). Statistics was adjusted to exclude interaction with ETT sizes.
CONCLUSION


The tracheal intubation modes did not affect ETCP during retractor splay. However, nasotracheal intubation had a beneficial effect on dysphonia recovery after ACSS.
LEVEL OF EVIDENCE


2.",2020,Mixed model analysis demonstrated that patients with nasotracheal intubation had significantly lower dysphonia scores after surgery (estimate treatment effect:,"['Anterior Cervical Spine Surgery', 'Adult patients undergoing ACSS', '110 patients to nasotracheal and orotracheal intubation']","['Tracheal Intubation Mode', 'endotracheal tube (ETT) and cervical retractors', 'tracheal intubation affects intraoperative endotracheal tube cuff pressure (ETCP', 'nasotracheal or orotracheal intubation under anesthesia', 'nasotracheal intubation']","['Cuff Pressure', 'dysphonia scores', 'mild change of voice', 'self-assessed hoarseness, pitch, and loudness of voice on postoperative days (PODs) 1, 2, 7, and 30', 'dysphonia recovery', 'maximal ETCP', 'hoarseness, pitch, and loudness']","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}]","[{'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation (procedure)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",110.0,0.315974,Mixed model analysis demonstrated that patients with nasotracheal intubation had significantly lower dysphonia scores after surgery (estimate treatment effect:,"[{'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Huang', 'Affiliation': 'Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Elise Chia-Hui', 'Initials': 'EC', 'LastName': 'Tan', 'Affiliation': 'National Research Institute of Chinese Medicine, Ministry of Health and Welfare and Institute of Hospital and Health Care Administration, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Chang', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Xavier T J', 'Initials': 'XTJ', 'LastName': 'Hsu', 'Affiliation': 'Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Kuei', 'Initials': 'WK', 'LastName': 'Chang', 'Affiliation': 'Taipei Gan-Dau Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shiang-Suo', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacology and Institute of Medicine, Chung Shan Medical University, and Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Pin-Tarng', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Chun', 'Initials': 'YC', 'LastName': 'Chu', 'Affiliation': 'Department of Anesthesiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}]",Spine,['10.1097/BRS.0000000000003339']
261,31778140,Antibody complementarity determining region design using high-capacity machine learning.,"MOTIVATION


The precise targeting of antibodies and other protein therapeutics is required for their proper function and the elimination of deleterious off-target effects. Often the molecular structure of a therapeutic target is unknown and randomized methods are used to design antibodies without a model that relates antibody sequence to desired properties.
RESULTS


Here, we present Ens-Grad, a machine learning method that can design complementarity determining regions of human Immunoglobulin G antibodies with target affinities that are superior to candidates derived from phage display panning experiments. We also demonstrate that machine learning can improve target specificity by the modular composition of models from different experimental campaigns, enabling a new integrative approach to improving target specificity. Our results suggest a new path for the discovery of therapeutic molecules by demonstrating that predictive and differentiable models of antibody binding can be learned from high-throughput experimental data without the need for target structural data.
AVAILABILITY AND IMPLEMENTATION


Sequencing data of the phage panning experiment are deposited at NIH's Sequence Read Archive (SRA) under the accession number SRP158510. We make our code available at https://github.com/gifford-lab/antibody-2019.
SUPPLEMENTARY INFORMATION


Supplementary data are available at Bioinformatics online.",2020,The precise targeting of antibodies and other protein therapeutics is required for their proper function and the elimination of deleterious off-target effects.,[],"['Antibody Complementarity Determining Region Design Using High-Capacity Machine Learning', 'machine learning']",[],[],"[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0021024', 'cui_str': 'Hypervariable Region, Immunoglobulin'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]",[],,0.033855,The precise targeting of antibodies and other protein therapeutics is required for their proper function and the elimination of deleterious off-target effects.,"[{'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'MIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Haoyang', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'MIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Mueller', 'Affiliation': 'MIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': 'MIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Ziheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'MIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Schilz', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Horny', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Birnbaum', 'Affiliation': 'Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ewert', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gifford', 'Affiliation': 'MIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA, USA.'}]","Bioinformatics (Oxford, England)",['10.1093/bioinformatics/btz895']
262,31176108,Neural mechanisms of expectancy-based placebo effects in antidepressant clinical trials.,"BACKGROUND


Patient expectancy of therapeutic improvement is a primary mediator of placebo effects in antidepressant clinical trials, but its mechanisms are poorly understood. This study employed a novel antidepressant trial design, with integrated functional magnetic resonance imaging (fMRI), to manipulate patient outcome expectancy and examine its neural mediators.
METHOD


Twenty-three depressed outpatients, in a randomized controlled trial were assigned to either Open (high outcome expectancy) or Placebo-controlled (low outcome expectancy) treatment with citalopram for eight weeks. fMRI scans were acquired before and after the expectancy manipulation (before medication treatment), while participants performed a masked emotional face task. Focusing on an amygdala region-of-interest (ROI), we tested a model where reduction in amygdala activation mediated outcome expectancy effects on the slope of change in depressive symptoms.
RESULTS


Following the manipulation, significant differences between conditions were found in neural activation changes in the amygdala, as well as in superior temporal gyrus, insula, and thalamus. Findings support the proposed mediation model according to which activation in the left amygdala ROI decreased significantly in the Open as opposed to the Placebo-controlled group following randomization (p = 0.009) for sad vs. neutral face contrast. The reduced left amygdala activation, in turn, was a significant predictor of decreased depressive symptoms during the trial (p = 0.007), and the mediation model was significant.
CONCLUSIONS


Results from this study, the first designed to identify the neural mechanisms of expectancy augmentation in an antidepressant randomized control trial, suggest that therapeutic modulation of amygdala activity may be an important pathway by which patient outcome expectancy influences depressive symptoms. CLINICALTRIALS.
GOV IDENTIFIER


NCT01919216; Trial name: Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms, URL: https://clinicaltrials.gov/ct2/show/NCT01919216.",2019,"Following the manipulation, significant differences between conditions were found in neural activation changes in the amygdala, as well as in superior temporal gyrus, insula, and thalamus.",['Twenty-three depressed outpatients'],"['Placebo-controlled (low outcome expectancy) treatment with citalopram', 'Placebo', 'integrated functional magnetic resonance imaging (fMRI']","['Depression: Cognitive and Neural Mechanisms, URL', 'left amygdala ROI', 'depressive symptoms', 'reduced left amygdala activation', 'neural activation changes']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C3541384', 'cui_str': 'Uniform resource locator (foundation metadata concept)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",23.0,0.175361,"Following the manipulation, significant differences between conditions were found in neural activation changes in the amygdala, as well as in superior temporal gyrus, insula, and thalamus.","[{'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha-Mano', 'Affiliation': 'Department of Psychology, University of Haifa Mount Carmel, Haifa, 31905, Israel. Electronic address: sigalzil@psy.haifa.ac.il.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: Zhishun.Wang@nyspi.columbia.edu.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Peterson', 'Affiliation': '(c)Keck School of Medicine University of Southern California, USA. Electronic address: bpeterson@chla.usc.edu.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: Melanie.Wall@nyspi.columbia.edu.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: chenying8787@163.com.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Department of Psychology and Neuroscience and the Institute of Cognitive Science University of Colorado at Boulder, USA. Electronic address: Tor.Wager@Colorado.EDU.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Brown', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: pb2410@cumc.columbia.edu.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Roose', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: spr2@cumc.columbia.edu.'}, {'ForeName': 'Bret R', 'Initials': 'BR', 'LastName': 'Rutherford', 'Affiliation': '(b)Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, USA. Electronic address: brr8@columbia.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.05.023']
263,31415914,Ketamine metabolite pilot study in a suicidal depression trial.,"Ketamine shows promise as a rapidly-acting treatment for depression and suicidal ideation, but side effects and abuse potential limit its use. Understanding its mechanism of action could help develop analogous but safer drugs. This post hoc study explored relationships of ketamine and metabolites, including hydroxynorketamine enantiomers, (2S,6S)- and (2R,6R)-HNK, to clinical response in a subgroup from a published trial in suicidal depression. Depressed adults with clinically significant suicidal ideation were randomized to double-blind infusion of sub-anesthetic ketamine or midazolam. Ketamine and metabolites were measured after infusion (N = 53). Plasma (2R,6R)-HNK was associated with change (higher levels correlated with less clinical improvement) from baseline to 24 h post-infusion of depression (HDRS-24: Spearman r = 0.37, p = 0.009) and suicidal thoughts (SSI: Spearman r = 0.29, p = 0.041). There were similar correlations with weekly follow-up clinical rating scores for both HNK enantiomers and dehydronorketamine (DHNK). Ketamine and norketamine were not associated with change in depression or suicidal ideation (unadjusted p > 0.28).",2019,Ketamine and norketamine were not associated with change in depression or suicidal ideation (unadjusted p > 0.28).,['Depressed adults with clinically significant suicidal ideation'],"['Ketamine metabolite', 'ketamine and metabolites, including hydroxynorketamine enantiomers, (2S,6S)- and (2R,6R)-HNK', 'Ketamine', 'ketamine or midazolam']","['depression or suicidal ideation', 'suicidal thoughts (SSI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",,0.294688,Ketamine and norketamine were not associated with change in depression or suicidal ideation (unadjusted p > 0.28).,"[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Grunebaum', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, USA; New York State Psychiatric Institute, USA. Electronic address: michael.grunebaum@nyspi.columbia.edu.'}, {'ForeName': 'Hanga C', 'Initials': 'HC', 'LastName': 'Galfalvy', 'Affiliation': 'Department of Biostatistics, Columbia University, Mailman School of Public Health, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Department of Biostatistics, Columbia University, Mailman School of Public Health, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Parris', 'Affiliation': 'New York State Psychiatric Institute, USA.'}, {'ForeName': 'Ainsley K', 'Initials': 'AK', 'LastName': 'Burke', 'Affiliation': 'New York State Psychiatric Institute, USA.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Suckow', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, USA; New York State Psychiatric Institute, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, USA; New York State Psychiatric Institute, USA; Analytical Psychopharmacology Laboratory, The Nathan S. Kline Institute for Psychiatric Research, USA.'}, {'ForeName': 'J John', 'Initials': 'JJ', 'LastName': 'Mann', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, USA; New York State Psychiatric Institute, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.08.005']
264,31586772,The effect of melatonin on depressive symptoms and anxiety in patients after acute coronary syndrome: The MEDACIS randomized clinical trial.,"BACKGROUND


Depression following acute coronary syndrome is prevalent and associated with increased mortality and morbidity. Melatonin may function as a primary prophylactic antidepressant substance and alleviate depressive symptoms. The study was undertaken to determine if melatonin administered following an acute coronary syndrome (ACS) could prevent development of depression.
METHODS


The study was a double-blinded, placebo-controlled, multicenter, randomized clinical trial performed in five primary care cardiology departments at Zealand, Denmark. Included patients were adults patients, free of depression at baseline, included at the latest 4 weeks after acute coronary syndrome. Twenty-five mg melatonin or placebo was administered 1 h before participants' bedtime for 12 weeks. The primary outcome is Major Depression Inventory (MDI) measured every two weeks throughout the trial. Incidence of depression was apriori defined as MDI score ≥ 21 during the trial. Reported exploratory outcomes were patterns of dropout and safety outcomes.
RESULTS


1220 patients were screened and 252 participants were randomized in a 1:1 ratio. Baseline MDI score in the melatonin and placebo group were, respectively, 6.18 (CI 5.32-7.05) and 5.98 (CI 5.19-6.77). No significant intergroup differences were found during the study in the intention-to-treat analysis or per-protocol analysis. Cumulative events of depressive episodes during the 12 weeks were six in the melatonin group and four in the placebo group. A significant drop in depressive symptoms were present throughout the study period. No intergroup differences were present in dropouts or adverse events.
CONCLUSIONS


Melatonin showed no prophylactic antidepressant effect following acute coronary syndrome. The non-significant results might be due to a type II error or melatonin might not be able to prevent development of depressive symptoms following ACS.",2019,No significant intergroup differences were found during the study in the intention-to-treat analysis or per-protocol analysis.,"['1220 patients were screened and 252 participants', 'Included patients were adults patients, free of depression at baseline, included at the latest 4 weeks after acute coronary syndrome', 'acute coronary syndrome', 'acute coronary syndrome (ACS', 'five primary care cardiology departments at Zealand, Denmark', 'patients after acute coronary syndrome']","['placebo', 'melatonin or placebo', 'Melatonin', 'melatonin', 'melatonin and placebo']","['Incidence of depression', 'dropouts or adverse events', 'Baseline MDI score', 'Cumulative events of depressive episodes', 'depressive symptoms', 'depressive symptoms and anxiety', 'Major Depression Inventory (MDI', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0587453', 'cui_str': 'Cardiology department (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",1220.0,0.714636,No significant intergroup differences were found during the study in the intention-to-treat analysis or per-protocol analysis.,"[{'ForeName': 'Michael Tvilling', 'Initials': 'MT', 'LastName': 'Madsen', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark; Department of Cardiology, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark; Department of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark; Department of Cardiology, Zealand University Hospital, Koegevej 7-13, 4000, Roskilde, Denmark; Department of Cardiology, Slagelse Sygehus, Ingemannsvej 18, 4200, Slagelse, Denmark; Department of Cardiology, Hvidovre Hospital, Kettegaard Alle 30, 2650, Hvidovre, Denmark; Psychiatric Research Unit, Region Zealand, Faelledvej 6, 4200, Slagelse, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: michael_madsen88@hotmail.com.'}, {'ForeName': 'Jawad Ahmad', 'Initials': 'JA', 'LastName': 'Zahid', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: ja_zahid@yahoo.dk.'}, {'ForeName': 'Christine Hangaard', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: christine.hangaard@gmail.com.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Grummedal', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark. Electronic address: olegrummedal@gmail.com.'}, {'ForeName': 'Jessica Roberts', 'Initials': 'JR', 'LastName': 'Hansen', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Faelledvej 6, 4200, Slagelse, Denmark. Electronic address: jfernisr1@gmail.com.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Isbrand', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark. Electronic address: andersisbrand@gmail.com.'}, {'ForeName': 'Ulla Overgaard', 'Initials': 'UO', 'LastName': 'Andersen', 'Affiliation': 'Department of Cardiology, Holbaek Hospital, Smedelundsgade 60, 4300, Holbaek, Denmark. Electronic address: uoa@regionsjaelland.dk.'}, {'ForeName': 'Lars Juel', 'Initials': 'LJ', 'LastName': 'Andersen', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Koegevej 7-13, 4000, Roskilde, Denmark. Electronic address: laad@regionsjaelland.dk.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Taskiran', 'Affiliation': 'Department of Cardiology, Hvidovre Hospital, Kettegaard Alle 30, 2650, Hvidovre, Denmark. Electronic address: mustafa.taskiran.01@regionh.dk.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Simonsen', 'Affiliation': 'Psychiatric Research Unit, Region Zealand, Faelledvej 6, 4200, Slagelse, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: es@regionsjaelland.dk.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gögenur', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: igo@regionsjaelland.dk.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.09.014']
265,32276987,First-line oxygen therapy with high-flow in bronchiolitis is not cost saving for the health service.,"BACKGROUND


Bronchiolitis is the most common reason for hospital admission in infants. High-flow oxygen therapy has emerged as a new treatment; however, the cost-effectiveness of using it as first-line therapy is unknown.
OBJECTIVE


To compare the cost of providing high-flow therapy as a first-line therapy compared with rescue therapy after failure of standard oxygen in the management of bronchiolitis.
METHODS


A within-trial economic evaluation from the health service perspective using data from a multicentre randomised controlled trial for hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand. Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733). Costs were applied using Australian costing sources and are reported in 2016-2017 AU$.
RESULTS


The incremental cost to avoid one treatment failure was AU$1778 (95% credible interval (CrI) 207 to 7096). Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay was AU$420 (95% CrI -176 to 1002) higher per infant in the early high-flow group compared with the rescue high-flow group. There was an 8% (95% CrI 7.5 to 8.6) likelihood of the early high-flow oxygen therapy being cost saving.
CONCLUSIONS


The use of high-flow oxygen as initial therapy for respiratory failure in infants with bronchiolitis is unlikely to be cost saving to the health system, compared with standard oxygen therapy with rescue high-flow.",2020,"Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733).","['hospital admission in infants', 'hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand', 'infants with bronchiolitis']","['High-flow oxygen therapy', 'standard oxygen and optional rescue high-flow']","['Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay', 'Intervention costs, length of hospital and intensive care stay and associated costs']","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.0885389,"Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733).","[{'ForeName': 'Vijay S', 'Initials': 'VS', 'LastName': 'Gc', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': 'The University of Queensland Child Health Research Centre, School of Medicine, Brisbane, Queensland, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia a.schibler@uq.edu.au.'}]",Archives of disease in childhood,['10.1136/archdischild-2019-318427']
266,30316810,Binge drinking and frequent or heavy drinking among adolescents: prevalence and associated factors.,"OBJECTIVE


To analyze the sociodemographic, school, and family factors associated with the patterns of binge drinking and frequent or heavy drinking among adolescents.
METHODS


This was a cross-sectional study, nested in a randomized controlled trial, of 6285 seventh and eighth grade adolescent students from Brazilian public schools. The associations between binge drinking (consumption of five or more doses of alcohol on a single occasion) in the last 12 months and frequent or heavy drinking (alcohol consumption on six or more days) in the last month and the several factors were analyzed through weighted logistic regression.
RESULTS


16.5% of the students reported binge drinking in the year before the interview and 2.2% reported frequent/heavy drinking in the previous month. The factors associated with binge drinking were cigarette smoking (OR=6.7, 95% CI=3.96; 11.23), use of marijuana (OR=2.2, 95% CI=1.17; 4.31), use of inhalant drugs (OR=3.0, 95% CI=1.98; 4.43), exposure to a drunk relative (OR=2.1, 95% C=1.67; 2.53), practice of bullying (OR=1.8, 95% CI=1.47; 2.17), verbal aggression (OR=1.7, 95%CI=1.40; 2.14), and intermediate/low school grades (OR=1.7, 95% CI=1.35; 2.20). The factors associated with frequent/heavy drinking were cigarette smoking (OR=2.5, 95% CI=1.16; 5.22), use of marijuana (OR=3.2, 95% CI=1.32; 7.72), and physical aggression (OR=2.2, 95% CI=1.36; 3.50).
CONCLUSIONS


The analyzed outcomes showed an association between the risk consumption of alcohol in early adolescence and low academic performance, involvement with other drugs, aggressiveness, and witnessing episodes of a family member's drunkenness. Considering the impact on public health of the damages caused by alcohol consumption during adolescence, these factors that showed such association should be considered in the development of preventive interventions.",2020,"The factors associated with frequent/heavy drinking were cigarette smoking (OR=2.5, 95% CI=1.16; 5.22), use of marijuana (OR=3.2, 95% CI=1.32; 7.72), and physical aggression (OR=2.2, 95% CI=1.36; 3.50).
","['6285 seventh and eighth grade adolescent students from Brazilian public schools', 'adolescents']",[],"['physical aggression', 'verbal aggression', ""risk consumption of alcohol in early adolescence and low academic performance, involvement with other drugs, aggressiveness, and witnessing episodes of a family member's drunkenness"", 'Binge drinking and frequent or heavy drinking', 'practice of bullying', 'frequent/heavy drinking', 'binge drinking', 'frequent or heavy drinking (alcohol consumption']","[{'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}]",[],"[{'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}, {'cui': 'C0424322', 'cui_str': 'Verbal aggression (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0001969', 'cui_str': 'Drunkenness'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",6285.0,0.0304906,"The factors associated with frequent/heavy drinking were cigarette smoking (OR=2.5, 95% CI=1.16; 5.22), use of marijuana (OR=3.2, 95% CI=1.32; 7.72), and physical aggression (OR=2.2, 95% CI=1.36; 3.50).
","[{'ForeName': 'Lara Silvia Oliveira', 'Initials': 'LSO', 'LastName': 'Conegundes', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Epidemiologia, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Juliana Y', 'Initials': 'JY', 'LastName': 'Valente', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Epidemiologia, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila Bertini', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Bioestatística, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Andreoni', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Bioestatística, Departamento de Medicina Preventiva, São Paulo, SP, Brazil.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Seção de Epidemiologia, Departamento de Medicina Preventiva, São Paulo, SP, Brazil. Electronic address: zila.sanchez@unifesp.br.'}]",Jornal de pediatria,['10.1016/j.jped.2018.08.005']
267,31735650,"Enhancing pharmacy personnel immunization-related confidence, perceived barriers, and perceived influence: The We Immunize program.","OBJECTIVES


Pharmacy personnel need practical strategies to incorporate nonseasonal vaccination services into pharmacy workflow. The objective of this study was to evaluate participants' confidence, perceived barriers and facilitators, and perceived influence on decision-making related to immunization services before and after the We Immunize program to assess program effectiveness.
DESIGN


Randomized controlled trial.
SETTING AND PARTICIPANTS


A total of 62 pharmacist-technician pairs from community pharmacies in Alabama and California participated in the randomized controlled trial. All participants were offered a 1-hour live immunization update. Intervention participants were also offered a 2-hour enhanced training at the beginning of the study period and tailored monthly feedback for 6 months.
OUTCOME MEASURES


A survey was administered at baseline and after the intervention. Likert-type scales were used to rank level of agreement and differences were analyzed using paired-sample t tests and 2-way mixed analysis of variance.
RESULTS


Sixty-seven participants completed both baseline and postintervention surveys (37 intervention; 30 control). Within the intervention group, participants' confidence in determining pneumococcal vaccine appropriateness (P = 0.027), confidence in pneumococcal vaccine-related patient interactions (P = 0.041), perceived external support (P = 0.016), and perceived influence on immunization services (P < 0.001) significantly improved. No change was observed within the control group. Compared to control participants, intervention participants showed a greater degree of change in perceived external support (P = 0.023) and influence on immunization services (P = 0.005) from baseline to post intervention. Neither confidence related to the herpes zoster vaccine nor marketing activities improved over the study period in either the intervention or control groups.
CONCLUSION


Immunization training, including educational interventions and tailored feedback, can be used to positively impact pharmacy personnel's confidence in providing pneumococcal vaccinations and perceptions related to environmental support and influence on immunization services. This, in turn, may increase immunization activities within community settings.",2020,"Neither confidence related to the herpes zoster vaccine nor marketing activities improved over the study period in either the intervention or control groups.
",['62 pharmacist-technician pairs from community pharmacies in Alabama and California participated'],['Immunization training'],"['pneumococcal vaccine appropriateness', 'marketing activities', 'immunization services', 'degree of change in perceived external support', 'perceived external support']","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",67.0,0.141058,"Neither confidence related to the herpes zoster vaccine nor marketing activities improved over the study period in either the intervention or control groups.
","[{'ForeName': 'Tessa J', 'Initials': 'TJ', 'LastName': 'Hastings', 'Affiliation': ''}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Hohmann', 'Affiliation': ''}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Huston', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'Salisa C', 'Initials': 'SC', 'LastName': 'Westrick', 'Affiliation': ''}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Garza', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2019.10.005']
268,31843375,Impact of the SIMPL-SYNC Refill Synchronization Program on medication adherence: A pragmatic randomized controlled trial.,"OBJECTIVE


To determine the impact of the SIMPL-SYNC refill synchronization (SSRS) service compared with that of usual care (UC) on medication adherence when applied as an opt-out strategy among patients receiving chronic medications.
DESIGN


This was a pragmatic randomized controlled trial.
SETTING AND PARTICIPANTS


The study was conducted in 2 community pharmacies located in Saskatchewan, Canada. Eligible patients were chronic medication users visiting the study pharmacies.
OUTCOME MEASURES


The primary outcome was the percentage of individuals achieving optimal adherence to all eligible study medications. Eligible study medications included 22 commonly used medication classes used to treat diverse conditions. Adherence was assessed for each medication class after 300 days using the proportion of days covered (PDC). Optimal adherence was defined as PDC ≥ 80%.
RESULTS


A total of 488 patients were screened for eligibility, and 190 patients were included in the intention-to-treat analysis (95 in SSRS, 95 in UC). The mean age of participants was 59 years, and 34% (65/190) were older than 65 years. A total of 574 individual adherence observations representing the 22 eligible study medication classes were generated from the 190 study participants. The percentage of individuals achieving optimal adherence to all their eligible study medications was 50.5% (48/95) in the SSRS group versus 44.2% (42/95) in the UC group (P = 0.383). Similarly, no statistically significant difference was observed in a per-protocol analysis assessing people who participated fully in the service; the percentage of individuals achieving optimal adherence to all their eligible study medications was 55.1% (38/69) in SSRS versus 40.7% (33/81) in UC (P = 0.080). Patient refusal of the refill synchronization services was common among randomized patients.
CONCLUSION


SSRS service failed to detect a robust improvement in medication adherence when delivered using an opt-out strategy. However, small improvements in adherence or benefits to specific subgroups of patients could not be ruled out.",2020,The percentage of individuals achieving optimal adherence to all their eligible study medications was 50.5% (48/95) in the SSRS group versus 44.2% (42/95) in the UC group (P = 0.383).,"['488 patients were screened for eligibility, and 190 patients were included in the intention-to-treat analysis (95 in SSRS, 95 in UC', 'The mean age of participants was 59 years, and 34% (65/190) were older than 65 years', 'A total of 574 individual adherence observations representing the 22 eligible study medication classes were generated from the 190 study participants', 'Eligible study medications included 22 commonly used medication classes used to treat diverse conditions', 'Eligible patients were chronic medication users visiting the study pharmacies', '2 community pharmacies located in Saskatchewan, Canada', 'patients receiving chronic medications']","['SIMPL-SYNC Refill Synchronization Program', 'SIMPL-SYNC refill synchronization (SSRS) service compared with that of usual care (UC']","['Adherence', 'percentage of individuals achieving optimal adherence', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0036234', 'cui_str': 'Saskatchewan'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",488.0,0.145564,The percentage of individuals achieving optimal adherence to all their eligible study medications was 50.5% (48/95) in the SSRS group versus 44.2% (42/95) in the UC group (P = 0.383).,"[{'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Blackburn', 'Affiliation': ''}, {'ForeName': 'Charity', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Mansell', 'Affiliation': ''}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jorgenson', 'Affiliation': ''}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Mansell', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Shevchuk', 'Affiliation': ''}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Aladwan', 'Affiliation': ''}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2019.10.010']
269,32277344,Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock.,"INTRODUCTION


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


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


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


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


ClinicalTrials.gov identifier, NCT02616354.",2020,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","['Patients with Sepsis and Septic Shock', 'Patients with sepsis and septic shock', 'Thirty-five patients were eventually enrolled']","['Imipenem', 'imipenem']","['plasma imipenem concentrations', 'pharmacokinetic/pharmacodynamic (PK/PD) parameters', 'percentage of patients achieving 40% T\u2009>\u2009MIC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0020933', 'cui_str': 'Imipenem'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020933', 'cui_str': 'Imipenem'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",35.0,0.14188,"No significant difference was observed in the percentage of patients achieving 40% T > MIC between the different infusion modes with the same dosage, although the two-step groups exhibited a significantly shorter T max  compared with the extended groups (0.5 g q6h: 1.5 ± 0.8 vs. 2.0 ± 0.0 h; 1.0 g q8h: 1.0 ± 0.6 vs. 2.0 ± 0.0 h; both, p < 0.05).","[{'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Pharmacy Department, Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zha', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Pharmacy Department, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. yiyiyang2004@163.com.'}]",Advances in therapy,['10.1007/s12325-020-01339-5']
270,32275771,The Effects of Weak and Strong CYP3A Induction by Rifampicin on the Pharmacokinetics of Five Progestins and Ethinylestradiol Compared to Midazolam.,"It is known that co-administration of CYP3A inducers may decrease the effectiveness of oral contraceptives containing progestins as mono-preparations or combined with ethinylestradiol. In a randomized clinical drug-drug interaction study, we investigated the effects of CYP3A induction on the pharmacokinetics of commonly used progestins and ethinylestradiol. Rifampicin was used to induce CYP3A. The progestins chosen as victim drugs were levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products, and drospirenone combined with ethinylestradiol. Postmenopausal women (n = 12-14 per treatment group) received, in fixed sequence, a single dose of the victim drug plus midazolam without rifampicin, with rifampicin 10 mg/day (weak induction), and with rifampicin 600 mg/day (strong induction). The effects on progestin exposure were compared with the effects on midazolam exposure (as a benchmark). Unbound concentrations were evaluated for drugs binding to sex hormone binding globulin. Weak CYP3A induction, as confirmed by a mean decrease in midazolam exposure by 46%, resulted in minor changes in progestin exposure (mean decreases: 15-37%). Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%). Namely, the magnitude of the observed induction effects varied from weak to strong. Our data might provide an impetus to revisit the currently applied clinical recommendations for oral contraceptives, especially for levonorgestrel and norethindrone-containing products, and they might give an indication as to which progestin could be used, if requested, by women taking weak CYP3A inducers-although it is acknowledged that the exact exposure-response relationship for contraceptive efficacy is currently unclear for most progestins.",2020,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).",['Postmenopausal women (n=12-14 per treatment group'],"['rifampicin', 'Rifampicin', 'levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products and drospirenone combined with ethinylestradiol', 'CYP3A induction', 'ethinylestradiol', 'victim drug plus midazolam without rifampicin, with rifampicin 10 mg/d (weak induction), and with rifampicin 600 mg/d (strong induction', 'midazolam', 'CYP3A']",[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0028356', 'cui_str': 'Norethindrone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]",[],,0.0299347,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).","[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Wiesinger', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Rottmann', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Nowotny', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Riecke', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Gashaw', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Brudny-Klöppel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fricke', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Höchel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Friedrich', 'Affiliation': 'Bayer AG, Berlin, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1848']
271,32186521,Postoperative Remote Automated Monitoring and Virtual Hospital-to-Home Care System Following Cardiac and Major Vascular Surgery: User Testing Study.,"BACKGROUND


Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascular surgery. However, the science of deploying and evaluating these systems is complex and subject to risk of implementation failure.
OBJECTIVE


As a precursor to a randomized controlled trial (RCT), this user testing study aimed to examine user performance and acceptance of a RAM and virtual hospital-to-home care intervention, using Philip's Guardian and Electronic Transition to Ambulatory Care (eTrAC) technologies, respectively.
METHODS


Nurses and patients participated in systems training and individual case-based user testing at two participating sites in Canada and the United Kingdom. Participants were video recorded and asked to think aloud while completing required user tasks and while being rated on user performance. Feedback was also solicited about the user experience, including user satisfaction and acceptance, through use of the Net Promoter Scale (NPS) survey and debrief interviews.
RESULTS


A total of 37 participants (26 nurses and 11 patients) completed user testing. The majority of nurse and patient participants were able to complete most required tasks independently, demonstrating comprehension and retention of required Guardian and eTrAC system workflows. Tasks which required additional prompting by the facilitator, for some, were related to the use of system features that enable continuous transmission of patient vital signs (eg, pairing wireless sensors to the patient) and assigning remote patient monitoring protocols. NPS scores by user group (nurses using Guardian: mean 8.8, SD 0.89; nurses using eTrAC: mean 7.7, SD 1.4; patients using eTrAC: mean 9.2, SD 0.75), overall NPS scores, and participant debrief interviews indicated nurse and patient satisfaction and acceptance of the Guardian and eTrAC systems. Both user groups stressed the need for additional opportunities to practice in order to become comfortable and proficient in the use of these systems.
CONCLUSIONS


User testing indicated a high degree of user acceptance of Philips' Guardian and eTrAC systems among nurses and patients. Key insights were provided that informed refinement of clinical workflow training and systems implementation. These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery.",2020,These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery.,"['Nurses and patients participated in systems training and individual case-based user testing at two participating sites in Canada and the United Kingdom', 'patients undergoing cardiac and major vascular surgery', '37 participants (26 nurses and 11 patients) completed user testing']","['Cardiac and Major Vascular Surgery', ""RAM and virtual hospital-to-home care intervention, using Philip's Guardian and Electronic Transition to Ambulatory Care (eTrAC) technologies"", 'Postoperative Remote Automated Monitoring and Virtual Hospital-to-Home Care System']","['overall NPS scores', 'NPS scores', 'comprehension and retention of required Guardian and eTrAC system workflows', 'nurse and patient satisfaction and acceptance of the Guardian and eTrAC systems']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",37.0,0.0384262,These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Carley', 'Initials': 'C', 'LastName': 'Ouellette', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Good', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Bird', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Shaunattonie', 'Initials': 'S', 'LastName': 'Henry', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Clyne', 'Affiliation': 'Hope for the Community CIC, Coventry, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'York University, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ritvo', 'Affiliation': 'York University, Toronto, ON, Canada.'}, {'ForeName': 'Nazari', 'Initials': 'N', 'LastName': 'Dvirnik', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lamy', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lawton', 'Affiliation': 'Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': 'Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Paterson', 'Affiliation': 'Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Duquette', 'Affiliation': 'Cardiac and Vascular Program, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Sanchez Medeiros', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Elias', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mills', 'Affiliation': 'Liverpool Heart and Chest Hospital, Liverpool, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrington', 'Affiliation': 'Liverpool Heart and Chest Hospital, Liverpool, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Field', 'Affiliation': 'Liverpool Heart and Chest Hospital, Liverpool, United Kingdom.'}, {'ForeName': 'Prathiba', 'Initials': 'P', 'LastName': 'Harsha', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'McGill University, Montreal, ON, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Peter', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Bhavnani', 'Affiliation': 'Scripps Clinic & Research Foundation, San Diego, CA, United States.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}]",Journal of medical Internet research,['10.2196/15548']
272,32202505,The Effectiveness of a Guided Internet-Based Tool for the Treatment of Depression and Anxiety in Pregnancy (MamaKits Online): Randomized Controlled Trial.,"BACKGROUND


Pregnant women with symptoms of depression or anxiety often do not receive adequate treatment. In view of the high incidence of these symptoms in pregnancy and their impact on pregnancy outcomes, getting treatment is of the utmost importance. A guided internet self-help intervention may help to provide more women with appropriate treatment.
OBJECTIVE


This study aimed to examine the effectiveness of a guided internet intervention (MamaKits online) for pregnant women with moderate to severe symptoms of anxiety or depression. Assessments took place before randomization (T0), post intervention (T1), at 36 weeks of pregnancy (T2), and 6 weeks postpartum (T3). We also explored effects on perinatal child outcomes 6 weeks postpartum.
METHODS


This randomized controlled trial included pregnant women (<30 weeks) with depressive symptoms above threshold (ie, Center for Epidemiological Studies Depression scale [CES-D] >16) or anxiety above threshold (ie, Hospital Anxiety and Depression Scale-Anxiety subscale [HADS-A] >8) or both of them. Participants were recruited via general media and flyers in prenatal care waiting rooms or via obstetricians and midwives. After initial assessment, women were randomized to (1) MamaKits online in addition to treatment as usual or (2) treatment as usual (control condition). MamaKits online is a 5-week guided internet intervention based on problem solving treatment. Guidance was was provided by trained students pursuing a Master's in Psychology. Outcomes were based on a Web-based self-report. Women in the control condition were allowed to receive the intervention after the last assessment (6 weeks postpartum).
RESULTS


Of the 159 included women, 79 were randomized to MamaKits online, 47% (79/37) of whom completed the intervention. Both groups showed a substantial decrease in affective symptoms on the CES-D, HADS-A, and Edinburgh Postnatal Depression Scale over time. In the intervention group, affective symptoms decreased more than that in the control group, but between-group effect sizes were small to medium (Cohen d at T3=0.45, 0.21, and 0.23 for the 3 questionnaires, respectively) and statistically not significant. Negative perinatal child outcomes did not differ between the 2 groups (χ 2 1 =0.1; P=.78). Completer analysis revealed no differences in outcome between the treatment completers and the control group. The trial was terminated early for reasons of futility based on the results of an interim analysis, which we performed because of inclusion problems.
CONCLUSIONS


Our study did show a significant reduction in affective symptoms in both groups, but the differences in reduction of affective symptoms between the intervention and control groups were not significant. There were also no differences in perinatal child outcomes. Future research should examine for which women these interventions might be effective or if changes in the internet intervention might make the intervention more effective.
TRIAL REGISTRATION


Netherlands Trial Register NL4162; https://tinyurl.com/sdckjek.",2020,"In the intervention group, affective symptoms decreased more than that in the control group, but between-group effect sizes were small to medium (Cohen d at T3=0.45, 0.21, and 0.23 for the 3 questionnaires, respectively) and statistically not significant.","['Pregnant women with symptoms of depression or anxiety', ""trained students pursuing a Master's in Psychology"", 'Of the 159 included women', 'pregnant women (<30 weeks) with depressive symptoms above threshold (ie, Center for Epidemiological Studies Depression scale [CES-D] >16) or', 'pregnant women with moderate to severe symptoms of anxiety or depression', 'Depression and Anxiety in Pregnancy (MamaKits Online', 'Participants were recruited via general media and flyers in prenatal care waiting rooms or via obstetricians and midwives']","['guided internet intervention (MamaKits online', 'MamaKits online in addition to treatment as usual or (2) treatment as usual (control condition', 'Guided Internet-Based Tool']","['Negative perinatal child outcomes', 'reduction of affective symptoms', 'affective symptoms', 'affective symptoms on the CES-D, HADS-A, and Edinburgh Postnatal Depression Scale', 'perinatal child outcomes', 'anxiety above threshold (ie, Hospital Anxiety and Depression Scale-Anxiety subscale [HADS-A']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443129', 'cui_str': 'Above threshold (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0002783', 'cui_str': 'Epidemiological Studies'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4543692', 'cui_str': 'Anxiety in pregnancy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician (occupation)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0443129', 'cui_str': 'Above threshold (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}]",159.0,0.130197,"In the intervention group, affective symptoms decreased more than that in the control group, but between-group effect sizes were small to medium (Cohen d at T3=0.45, 0.21, and 0.23 for the 3 questionnaires, respectively) and statistically not significant.","[{'ForeName': 'Hanna M', 'Initials': 'HM', 'LastName': 'Heller', 'Affiliation': 'Department of Psychiatry, Amsterdam Universitair Medische Centra, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Adriaan W', 'Initials': 'AW', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Psychiatry, Amsterdam Universitair Medische Centra, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Honig', 'Affiliation': 'Department of Psychiatry, Amsterdam Universitair Medische Centra, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birit F P', 'Initials': 'BFP', 'LastName': 'Broekman', 'Affiliation': 'Department of Psychiatry, Amsterdam Universitair Medische Centra, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/15172']
273,31831363,"Effects of DHA-enriched fish oil on gene expression levels of p53 and NF-κB and PPAR-γ activity in PBMCs of patients with T2DM: A randomized, double-blind, clinical trial.","BACKGROUND AND AIMS


Omega-3 polyunsaturated fatty acids (PUFAs) are natural peroxisome proliferator-activated receptor gamma (PPAR-γ) ligands. Activated PPAR-γ protects the cardiovascular system against atherosclerotic lesion formation and exerts its anti-inflammatory role by suppressing cytokines induced by nuclear factor kappa-B (NF-κB) in endothelial cells (ECs), and it is hypothesized that apoptosis and cell cycle arrest induced by PPAR-γ ligands may be mediated by the p53-dependent pathway. The aim of our study was to investigate the effects of docosahexaenoic acid (DHA)-enriched fish oil supplement on PPAR-γ activity and mRNA expression levels of p53 and NF-κB.
METHODS AND RESULTS


Fifty patients with type 2 diabetes mellitus (T2DM) aged 30-70 years were randomly assigned to receive either 2400 mg/d DHA-rich fish oil or placebo for 8 weeks. Metabolic parameters were assessed at baseline and at the end of the intervention. PPAR-γ activity in the peripheral blood mononuclear cells (PBMCs) was measured using ELISA-based PPAR-γ Transcription Factor Assay Kit, and the gene expression levels of p53 and NF-κB were assessed using real-time quantitative reverse transcription polymerase chain reaction (RT-PCR). On the basis of our finding, 8 weeks of treatment with DHA-rich fish oil increased PPAR-γ activity in PBMCs of subjects with T2DM (p < 0.01) compared to that in placebo (p = 0.4). Between-group comparisons of mean PPAR-γ activity changes showed significant differences (p = 0.03), whereas mRNA expression levels of the p53 and NF-κB genes did not show significant differences between studied groups (p = 0.2 and p = 0.5, respectively).
CONCLUSION


Our findings indicated that short-term DHA-rich fish oil supplementation may modulate PPAR-γ activity in PBMCs.",2020,"Between-group comparisons of mean PPAR-γ activity changes showed significant differences (p = 0.03), whereas mRNA expression levels of the p53 and NF-κB genes did not show significant differences between studied groups (p = 0.2 and p = 0.5, respectively).
","['Fifty patients with type 2 diabetes mellitus (T2DM) aged 30-70 years', 'patients with T2DM']","['DHA-rich fish oil', 'DHA-enriched fish oil', 'Omega-3 polyunsaturated fatty acids (PUFAs', 'placebo', '2400\xa0mg/d DHA-rich fish oil or placebo', 'docosahexaenoic acid (DHA)-enriched\xa0fish oil supplement']","['Metabolic parameters', 'PPAR-γ activity', 'gene expression levels of p53 and NF-κB and PPAR-γ activity', 'mean PPAR-γ activity changes', 'PPAR-γ activity and mRNA expression levels', 'mRNA expression levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",50.0,0.273975,"Between-group comparisons of mean PPAR-γ activity changes showed significant differences (p = 0.03), whereas mRNA expression levels of the p53 and NF-κB genes did not show significant differences between studied groups (p = 0.2 and p = 0.5, respectively).
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Naeini', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran; Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Toupchian', 'Affiliation': 'Department of Nutrition and Public Health, School of Health, North Khorasan University of Medical Science, Bojnurd, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Vatannejad', 'Affiliation': ""Department of Comparative Biosciences, Faculty of Veterinary Medicine, University of Tehran, Iran; Students' Scientific Research Center (SSRC), Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Gity', 'Initials': 'G', 'LastName': 'Sotoudeh', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Teimouri', 'Affiliation': ""Department of Clinical Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran; Students' Scientific Research Center (SSRC), Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Ghorbani', 'Affiliation': 'Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Nasli-Esfahani', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Koohdani', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: fkoohdan@tums.ac.ir.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.10.012']
274,32007334,Associations of telomere length with anthropometric and glucose changes after a lifestyle intervention in abdominal obese children.,"BACKGROUND AND AIMS


In lifestyle intervention studies, we demonstrated that changes in telomere length (TL) were associated with changes in anthropometric indices. Therefore, our new hypothesis is that TL could be a predictor of changes in anthropometric or metabolic measures in children with abdominal obesity. The aim of the study was to evaluate the association between anthropometric and biochemical measurements with TL before and after an 8-week lifestyle intervention in children with abdominal obesity (7-16 years old).
METHODS AND RESULTS


We assessed anthropometric and biochemical outcomes at baseline and after 8-week lifestyle intervention in 106 children with abdominal obesity (11.30 ± 2.49 years old, 63% girls). TL was measured by monochrome multiplex real-time quantitative PCR. After the lifestyle intervention, anthropometric parameters and glucose metabolism indicators significantly improved in the participants. TL did not change after the intervention in participants. Significant negative correlations between baseline TL and anthropometric measures (BMI, body weight and waist circumference) were observed. Furthermore, baseline TL was a predictor for changes in blood glucose levels after the lifestyle intervention.
CONCLUSIONS


An inverse correlation between TL and obesity traits was observed in children with abdominal obesity. Interestingly, we found that baseline TL could predict changes in blood glucose levels.
CLINICAL TRIAL


NCT03147261. Registered 10 May 2017.",2020,TL did not change after the intervention in participants.,"['106 children with abdominal obesity (11.30\xa0±\xa02.49 years old, 63% girls', 'children with abdominal obesity', 'abdominal obese children', 'children with abdominal obesity (7-16 years old']",['lifestyle intervention'],"['blood glucose levels', 'anthropometric parameters and glucose metabolism indicators', 'TL', 'TL and obesity traits', 'baseline TL and anthropometric measures (BMI, body weight and waist circumference', 'telomere length (TL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C4708661', 'cui_str': '2.49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",106.0,0.0414692,TL did not change after the intervention in participants.,"[{'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Morell-Azanza', 'Affiliation': 'Department of Nutrition, Food Science and Physiology, University of Navarra, Pamplona, Spain; IdiSNA (Navarra Institute for Health Research), Pamplona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ojeda-Rodríguez', 'Affiliation': 'Department of Nutrition, Food Science and Physiology, University of Navarra, Pamplona, Spain; IdiSNA (Navarra Institute for Health Research), Pamplona, Spain.'}, {'ForeName': 'Ma Cristina', 'Initials': 'MC', 'LastName': 'Azcona-SanJulián', 'Affiliation': 'IdiSNA (Navarra Institute for Health Research), Pamplona, Spain; Paediatric Endocrinology Unit, Department of Pediatrics, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Zalba', 'Affiliation': 'IdiSNA (Navarra Institute for Health Research), Pamplona, Spain; Department of Biochemistry and Genetics, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Marti', 'Affiliation': 'Department of Nutrition, Food Science and Physiology, University of Navarra, Pamplona, Spain; IdiSNA (Navarra Institute for Health Research), Pamplona, Spain; Center of Biomedical Research in Physiopathology of Obesity and Nutrition (CIBEROBN), Institute of Health Carlos III, Madrid, Spain. Electronic address: amarti@unav.es.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.12.002']
275,32144955,No QTc Prolongation With Zanubrutinib: Results of Concentration-QTc Analysis From a Thorough QT Study in Healthy Subjects.,"This thorough QT (TQT) study evaluated the effect of zanubrutinib on electrocardiogram (ECG) parameters by using concentration-QTc (C-QTc) analysis as the primary analysis for this study. Part A of the study determined the safety and tolerability of a single supratherapeutic dose of zanubrutinib (480 mg) in healthy volunteers. Part B was a randomized, blinded, placebo-controlled and positive-controlled, four-way crossover, TQT study of single therapeutic (160 mg) and supratherapeutic (480 mg) doses of zanubrutinib, placebo, and open-label moxifloxacin 400 mg. Thirty-two participants received at least 1 dose of zanubrutinib, and 26 participants completed all 4 periods. Zanubrutinib did not have any effect on heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology) and was generally well-tolerated. Using C-QTc analysis, the predicted placebo-corrected change-from-baseline QT interval using Fridericia's formula (ΔΔQTcF) was -3.4 msec (90% confidence interval: -4.9 to -1.9 msec) at peak concentrations of the 480 mg dose. A QT effect (ΔΔQTcF) exceeding 10 msec could be excluded within the observed concentration range at 160 and 480 mg doses. Assay sensitivity was established by moxifloxacin with 90% lower bound exceeding 5 msec. Implementing a C-QTc analysis prospectively in this TQT study resulted in a substantially smaller sample size to maintain a similar study power as shown in the traditional time-point analysis. A single 160-mg or 480-mg zanubrutinib dose did not prolong the QTc interval or have any other clinically relevant effects on ECG parameters.",2020,"Zanubrutinib did not have any effect on heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology) and was generally well tolerated.","['healthy volunteers', 'Healthy Subjects']","['moxifloxacin', 'single therapeutic (160-mg) and supratherapeutic (480-mg) doses of zanubrutinib, placebo, and open-label moxifloxacin', 'placebo']","['tolerated', 'safety and tolerability', 'Assay sensitivity', 'heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology', 'QTc interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction (observable entity)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0429103', 'cui_str': 'T wave feature'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.159918,"Zanubrutinib did not have any effect on heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology) and was generally well tolerated.","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Mu', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'eResearchTechnology, Inc. (ERT), Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Novotny', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Tawashi', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'eResearchTechnology, Inc. (ERT), Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Willett', 'Affiliation': 'Frontage Clinical Services, Inc., Secaucus, New Jersey, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Sahasranaman', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Ying C', 'Initials': 'YC', 'LastName': 'Ou', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}]",Clinical and translational science,['10.1111/cts.12779']
276,32191071,Setting a goal could help you control: Comparing the effect of health goal versus general episodic future thinking on health behaviors among cigarette smokers and obese individuals.,"Episodic Future Thinking (EFT) reduces delay discounting (DD; preference for smaller, immediate rewards) and various maladaptive behaviors. Exploring potential personalization of EFT to optimize its ability to alter DD and demand for unhealthy reinforcers is important for the development of interventions targeting long-term improvement and maintenance of health. In this investigation, using 2 separate studies, we examined the effects of EFT with and without a health goal on rates of discounting, demand, and craving for cigarettes and fast food among cigarette smokers and obese individuals, respectively. Using data collected from Amazon Mechanical Turk (mTurk), Study 1 ( N  = 189) examined the effect of EFT on DD and measures of cigarette demand and craving in cigarette smokers who were randomly assigned to 1 of 3 conditions: EFT-health goal, EFT-general, or Episodic Recent Thinking (ERT)-general. Study 2 ( N  = 255), using a 2x2 factorial design, examined the effects of health goals and general EFT on DD and measures of fast food demand and craving in obese individuals who were randomly assigned to 1 of 4 conditions: EFT-health goal, EFT-general, ERT-health goal or ERT-general. Health goal EFT was not more effective than general EFT in reducing monetary discounting. However, the addition of a health goal to general EFT was significantly associated with higher effect on intensity and elasticity of demand for cigarettes and fast food compared to EFT without a health goal. These findings suggest that the amplification of future thinking through the inclusion of a health goal may promote healthy decisions and result in positive behavior changes. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Health goal EFT was not more effective than general EFT in reducing monetary discounting.,"['obese individuals who were randomly assigned to 1 of 4 conditions: EFT-health goal, EFT-general, ERT-health goal or ERT-general', 'cigarette smokers who were randomly assigned to 1 of 3 conditions: EFT-health goal, EFT-general, or Episodic Recent Thinking (ERT)-general', 'cigarette smokers and obese individuals']","['EFT', 'Episodic Future Thinking (EFT', 'health goals and general EFT', 'health goal versus general episodic future thinking']","['intensity and elasticity of demand for cigarettes and fast food', 'rates of discounting, demand, and craving for cigarettes and fast food', 'health behaviors']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0013764'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0018687'}]",,0.0442723,Health goal EFT was not more effective than general EFT in reducing monetary discounting.,"[{'ForeName': 'Liqa N', 'Initials': 'LN', 'LastName': 'Athamneh', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Madison D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Center for Transformative Research on Health Behaviors.'}, {'ForeName': 'Elysia H', 'Initials': 'EH', 'LastName': 'Lin', 'Affiliation': 'Center for Transformative Research on Health Behaviors.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Stein', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Mellis', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Kirstin M', 'Initials': 'KM', 'LastName': 'Gatchalian', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Addiction Recovery Research Center.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000351']
277,32078436,Cocoa to Improve Walking Performance in Older People With Peripheral Artery Disease: The COCOA-PAD Pilot Randomized Clinical Trial.,"RATIONALE


Cocoa and its major flavanol component, epicatechin, have therapeutic properties that may improve limb perfusion and increase calf muscle mitochondrial activity in people with lower extremity peripheral artery disease (PAD).
OBJECTIVE


In a phase II randomized clinical trial, to assess whether 6 months of cocoa improved walking performance in people with PAD, compared with placebo.
METHODS AND RESULTS


Six-month double-blind, randomized clinical trial in which participants with PAD were randomized to either cocoa beverage versus placebo beverage. The cocoa beverage contained 15 g of cocoa and 75 mg of epicatechin daily. The identical appearing placebo contained neither cocoa nor epicatechin. The 2 primary outcomes were 6-month change in 6-minute walk distance measured 2.5 hours after a study beverage at 6-month follow-up and 24 hours after a study beverage at 6-month follow-up, respectively. A 1-sided  P <0.10 was considered statistically significant. Of 44 PAD participants randomized (mean age, 72.3 years [±7.1]; mean ankle brachial index, 0.66 [±0.15]), 40 (91%) completed follow-up. Adjusting for smoking, race, and body mass index, cocoa improved 6-minute walk distance at 6-month follow-up by 42.6 m ([90% CI, +22.2 to +∞]  P =0.005) at 2.5 hours after a final study beverage and by 18.0 m ([90% CI, -1.7 to +∞]  P =0.12) at 24 hours after a study beverage, compared with placebo. In calf muscle biopsies, cocoa improved mitochondrial COX (cytochrome c oxidase) activity ( P =0.013), increased capillary density ( P =0.014), improved calf muscle perfusion ( P =0.098), and reduced central nuclei ( P =0.033), compared with placebo.
CONCLUSIONS


These preliminary results suggest a therapeutic effect of cocoa on walking performance in people with PAD. Further study is needed to definitively determine whether cocoa significantly improves walking performance in people with PAD.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT02876887. Visual Overview: An online visual overview is available for this article.",2020,"In calf muscle biopsies, cocoa improved mitochondrial cytochrome c oxidase activity (P=0.013), increased capillary density (P=0.014), improved calf muscle perfusion (P=0.098), and reduced central nuclei (P=0.024), compared to placebo.  ","['people with lower extremity peripheral artery disease (PAD', 'Older People With Peripheral Artery Disease', '44 PAD participants randomized (mean age: 72.3 years (+7.1), mean ankle brachial index 0.66 (+0.15)), 40 (91%) completed follow-up', 'participants with PAD', 'people with PAD']","['placebo', 'cocoa beverage vs. placebo beverage', 'cocoa nor epicatechin', 'cocoa', 'Cocoa']","['mitochondrial cytochrome c oxidase activity', 'Walking Performance', 'calf muscle perfusion', 'six-month change in six-minute walk distance', 'walking performance', 'capillary density', 'reduced central nuclei']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0014485', 'cui_str': '(2R,3R)-2-(3,4-Dihydroxyphenyl)-3,5,7-chromanetriol'}]","[{'cui': 'C0010760', 'cui_str': 'Electron Transport Complex IV'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0007763', 'cui_str': 'Central Nuclei'}]",,0.668891,"In calf muscle biopsies, cocoa improved mitochondrial cytochrome c oxidase activity (P=0.013), increased capillary density (P=0.014), improved calf muscle perfusion (P=0.098), and reduced central nuclei (P=0.024), compared to placebo.  ","[{'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Criqui', 'Affiliation': 'Department of Family Medicine, University of California at San Diego (M.H.C.).'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Domanchuk', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Ferrucci', 'Affiliation': 'Division of Intramural Research, National Institute on Aging, Baltimore, MD (L.F.).'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology, University of Maryland, Baltimore (J.M.G.).'}, {'ForeName': 'Melina R', 'Initials': 'MR', 'LastName': 'Kibbe', 'Affiliation': 'Department of Surgery, University of North Carolina School of Medicine, Chapel Hill (M.R.K.).'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Kosmac', 'Affiliation': 'Department of Rehabilitation Sciences, University of Kentucky College of Health Sciences, Lexington (K.K., C.A.P.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Kramer', 'Affiliation': 'Department of Radiology and Medical Imaging, University of Virginia Health System, Charlottesville (C.M.K.).'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Leeuwenburgh', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville (C.L.).'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Lloyd-Jones', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Peterson', 'Affiliation': 'Department of Rehabilitation Sciences, University of Kentucky College of Health Sciences, Lexington (K.K., C.A.P.).'}, {'ForeName': 'Tamar S', 'Initials': 'TS', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of Chicago, IL (T.S.P.).'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison (J.H.S.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sufit', 'Affiliation': 'Neurology (R.S.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Preventive Medicine (M.M.M., D.L.-J., L.V.H., L.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Villarreal', 'Affiliation': 'Divisions of Cardiology (F.V.), University of San Diego, CA.'}, {'ForeName': 'Dongxue', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Departments of Medicine (M.M.M., K.D., L.L., D.L.-J., D.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Preventive Medicine (M.M.M., D.L.-J., L.V.H., L.Z.), Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Department of Health Research and Policy, Stanford University, CA (L.T.).'}]",Circulation research,['10.1161/CIRCRESAHA.119.315600']
278,32274500,Pilot Study of a Novel Approach Management of Sleep Associated Problems in Breast Cancer Patients (MOSAIC) During Chemotherapy.,"STUDY OBJECTIVES


This pilot RCT was conducted to assess the preliminary effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) delivered by trained research staff in comparison to a sleep hygiene pamphlet control, and to assess moderators of treatment effect in breast cancer patients undergoing chemotherapy.
METHODS


Of 74 participants recruited, 37 were randomized to BBT-CI and 37 were randomized to the control condition. Trained staff members delivered the intervention during chemotherapy treatments to reduce burden on the patients. Insomnia was assessed with the Insomnia Severity Index (ISI), anxiety was assessed with the Spielberger State-Trait Anxiety Inventory (STAI), symptom burden was assessed with the Symptom Inventory (SI), and study staff recorded previous treatments and surgeries received by patients.
RESULTS


Patients randomized to BBT-CI showed significantly greater improvements in their ISI scores than the sleep hygiene group. Additionally, several treatment moderators were identified. The effect of BBT-CI was greater among individuals with lower baseline state-trait anxiety, with previous surgery for cancer, and with higher baseline somatic symptom severity.
CONCLUSIONS


BBT-CI shows preliminary efficacy compared to the sleep hygiene handout on insomnia in cancer patients undergoing chemotherapy. A large phase III RCT needs to be conducted to replicate the preliminary findings.",2020,"RESULTS


Patients randomized to BBT-CI showed significantly greater improvements in their ISI scores than the sleep hygiene group.","['Breast Cancer Patients (MOSAIC', 'cancer patients undergoing chemotherapy', 'Of 74 participants recruited, 37 were randomized to', 'breast cancer patients undergoing chemotherapy', 'Cancer-Related Insomnia (BBT-CI']","['BBT-CI', 'Brief Behavioral Therapy']","['BBT-CI', 'Insomnia', 'Spielberger State-Trait Anxiety Inventory (STAI), symptom burden', 'Insomnia Severity Index (ISI), anxiety', 'ISI scores']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439750', 'cui_str': 'Mosaic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}]",74.0,0.0578566,"RESULTS


Patients randomized to BBT-CI showed significantly greater improvements in their ISI scores than the sleep hygiene group.","[{'ForeName': 'Oxana', 'Initials': 'O', 'LastName': 'Palesh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Solomon', 'Affiliation': 'PGSP Stanford Psy.D. Consortium.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University.'}, {'ForeName': 'Hanyang', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cassidy-Eagle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine, Stanford University.'}, {'ForeName': 'Pasquale F', 'Initials': 'PF', 'LastName': 'Innominato', 'Affiliation': 'North Wales Cancer Centre, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, UK & Cancer Chronotherapy Team, Cancer Research Centre, Division of Biomedical Sciences, Warwick Medical School, Coventry, UK & Unit 935, French National Institute for Health and Medical Research (INSERM), Villejuif, France.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mustian', 'Affiliation': 'University of Rochester, NY.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'University of Texas at Austin.'}]",Sleep,['10.1093/sleep/zsaa070']
279,30998929,Can a social media campaign increase the use of long-acting reversible contraception? Evidence from a cluster randomized control trial using Facebook.,"OBJECTIVE


To test whether an informational campaign carried out on social media increased use of long-acting reversible contraception (LARC).
STUDY DESIGN


We implemented a stratified cluster randomized control trial to identify the effect of an informational campaign carried out using Facebook advertisements designed to increase knowledge of the efficacy, ease of use and safety of LARC. We randomized all zip codes in a three-state study area to either a control group or a treatment group. Female Facebook users age 18-34 living in treated clusters received advertisements developed by the researchers in partnership with Planned Parenthood of Northern New England (PPNNE), which sponsored the campaign. We assessed changes in the number and rate of LARC insertions at PPNNE health centers by patients' treatment status.
RESULTS


Facebook showed 1.8 million advertisements to women residing in 536 randomly assigned treatment clusters. Women living in 545 control clusters did not receive advertisements. We observed 152,743 patient visits across PPNNE's 21 health centers over a 26-month period spanning the advertisement campaign. After treatment, the number of LARC insertions increased by 5.7% (95% CI 0.4%-11.3%, p=.04) among patients living in treated relative to control clusters. This result, however, is driven by patients at a single large health center that was experiencing an increase in patient volume prior to the intervention. If we drop this clinic from the sample, we find no evidence that the campaign had an effect on LARC insertions (0.8% reduction, 95% CI -7.6 to 6.5, p=.83). Moreover, if we control for patient volume, we also find no evidence that the campaign increased insertions per patient (0.5% relative increase in insertions, 95% CI -4.9% to 5.2%, p=.87).
CONCLUSION


We conclude that the intervention did not have a detectable impact on LARC insertions in the 4 months after the ad campaign.
IMPLICATIONS


This project demonstrates the importance of evaluating the impact of resources invested on advertising with the goal of promoting public health.",2019,"Female Facebook users age 18-34 living in treated clusters received advertisements developed by the researchers in partnership with Planned Parenthood of Northern New England (PPNNE), which sponsored the campaign.","[""152,743 patient visits across PPNNE's 21 health centers over a 26-month period spanning the advertisement campaign"", 'Female Facebook users age 18-34 living in treated clusters received']","['advertisements developed by the researchers in partnership with Planned Parenthood of Northern New England (PPNNE', 'Facebook', 'informational campaign carried out on social media increased use of long-acting reversible contraception (LARC']","['number of LARC insertions', 'LARC insertions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0337469', 'cui_str': 'Parenthood (observable entity)'}, {'cui': 'C0027965', 'cui_str': 'Northeastern United States'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.105722,"Female Facebook users age 18-34 living in treated clusters received advertisements developed by the researchers in partnership with Planned Parenthood of Northern New England (PPNNE), which sponsored the campaign.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Byker', 'Affiliation': 'Department of Economics Middlebury College.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Myers', 'Affiliation': 'Department of Economics Middlebury College. Electronic address: cmyers@middlebury.edu.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Graff', 'Affiliation': 'Planned Parenthood of Northern New England (PPNNE).'}]",Contraception,['10.1016/j.contraception.2019.04.001']
280,32127335,Effects of fish oil and curcumin supplementation on cerebrovascular function in older adults: A randomized controlled trial.,"BACKGROUND AND AIMS


Chronic conditions such as obesity, which contribute to endothelial dysfunction in older adults, can cause impairments in cerebrovascular perfusion, which is associated with accelerated cognitive decline. Supplementing the diet with bioactive nutrients that can enhance endothelial function, such as fish oil or curcumin, may help to counteract cerebrovascular dysfunction.
METHODS AND RESULTS


A 16-week double-blind, randomized placebo-controlled trial was undertaken in 152 older sedentary overweight/obese adults (50-80 years, body mass index: 25-40 kg/m 2 ) to investigate effects of fish oil (2000 mg docosahexaenoic acid + 400 mg eicosapentaenoic acid/day), curcumin (160 mg/day) or a combination of both on cerebrovascular function (measured by Transcranial Doppler ultrasound), systemic vascular function (blood pressure, heart rate and arterial compliance) and cardiometabolic (fasting glucose and blood lipids) and inflammatory (C-reactive protein) biomarkers. The primary outcome, cerebrovascular responsiveness to hypercapnia, was not affected by the interventions. However, cerebral artery stiffness was significantly reduced in males following fish oil supplementation (P = 0.007). Furthermore, fish oil reduced heart rate (P = 0.038) and serum triglycerides (P = 0.006) and increased HDL cholesterol (P = 0.002). Curcumin did not significantly affect these outcomes either alone or in combination with fish oil.
CONCLUSION


Regular supplementation with fish oil but not curcumin improved biomarkers of cardiovascular and cerebrovascular function. The combined supplementation did not result in additional benefits. Further studies are warranted to identify an efficacious curcumin dose and to characterize (in terms of sex, BMI, cardiovascular and metabolic risk factors) populations whose cerebrovascular and cognitive functions might benefit from either intervention.
CLINICAL TRIAL REGISTRATION


ACTRN12616000732482p.",2020,"Furthermore, fish oil reduced heart rate (P = 0.038) and serum triglycerides (P = 0.006) and increased HDL cholesterol (P = 0.002).","['152 older sedentary overweight/obese adults (50-80 years, body mass index: 25-40\xa0kg/m 2 ', 'older adults']","['fish oil and curcumin supplementation', 'placebo', 'fish oil (2000\xa0mg docosahexaenoic acid\xa0+\xa0400\xa0mg eicosapentaenoic acid/day), curcumin (160\xa0mg/day) or a combination of both on cerebrovascular function']","['cerebrovascular function', 'HDL cholesterol', 'cerebrovascular responsiveness to hypercapnia', 'systemic vascular function (blood pressure, heart rate and arterial compliance) and cardiometabolic (fasting glucose and blood lipids) and inflammatory (C-reactive protein) biomarkers', 'cerebral artery stiffness', 'serum triglycerides', 'biomarkers of cardiovascular and cerebrovascular function', 'heart rate']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007770', 'cui_str': 'Cerebral Arteries'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}]",152.0,0.497875,"Furthermore, fish oil reduced heart rate (P = 0.038) and serum triglycerides (P = 0.006) and increased HDL cholesterol (P = 0.002).","[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kuszewski', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia; Institute for Resilient Regions, University of Southern Queensland, Springfield Central, Australia.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Wood', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia; Priority Research Centre for Healthy Lungs, Hunter Medical Research Institute, University of Newcastle, NSW, Australia.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia; Institute for Resilient Regions, University of Southern Queensland, Springfield Central, Australia. Electronic address: peter.howe@newcastle.edu.au.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.12.010']
281,32127340,Liraglutide decreases energy expenditure and does not affect the fat fraction of supraclavicular brown adipose tissue in patients with type 2 diabetes.,"BACKGROUND AND AIMS


Several studies have shown that glucagon-like peptide-1 (GLP-1) analogues can affect resting energy expenditure, and preclinical studies suggest that they may activate brown adipose tissue (BAT). The aim of the present study was to investigate the effect of treatment with liraglutide on energy metabolism and BAT fat fraction in patients with type 2 diabetes.
METHODS AND RESULTS


In a 26-week double-blind, placebo-controlled trial, 50 patients with type 2 diabetes were randomized to treatment with liraglutide (1.8 mg/day) or placebo added to standard care. At baseline and after treatment for 4, 12 and 26 weeks, we assessed resting energy expenditure (REE) by indirect calorimetry. Furthermore, at baseline and after 26 weeks, we determined the fat fraction in the supraclavicular BAT depot using chemical-shift water-fat MRI at 3T. Liraglutide reduced REE after 4 weeks, which persisted after 12 weeks and tended to be present after 26 weeks (week 26 vs baseline: liraglutide -52 ± 128 kcal/day; P = 0.071, placebo +44 ± 144 kcal/day; P = 0.153, between group P = 0.057). Treatment with liraglutide for 26 weeks did not decrease the fat fraction in supraclavicular BAT (-0.4 ± 1.7%; P = 0.447) compared to placebo (-0.4 ± 1.4%; P = 0.420; between group P = 0.911).
CONCLUSION


Treatment with liraglutide decreases REE in the first 12 weeks and tends to decrease this after 26 weeks without affecting the fat fraction in the supraclavicular BAT depot. These findings suggest reduction in energy intake rather than an increase in REE to contribute to the liraglutide-induced weight loss.
TRIAL REGISTRY NUMBER


NCT01761318.",2020,"Liraglutide reduced REE after 4 weeks, which persisted after 12 weeks and tended to be present after 26 weeks (week 26 vs baseline: liraglutide -52 ± 128 kcal/day; P = 0.071, placebo +44 ± 144 kcal/day; P = 0.153, between group P = 0.057).","['patients with type 2 diabetes', '50 patients with type 2 diabetes']","['Liraglutide', 'placebo added to standard care', 'placebo', 'liraglutide', 'glucagon-like peptide-1']","['REE', 'resting energy expenditure (REE', 'fat fraction in supraclavicular BAT', 'energy metabolism and BAT fat fraction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach (qualifier value)'}, {'cui': 'C0008139', 'cui_str': 'Bats'}]",50.0,0.17626,"Liraglutide reduced REE after 4 weeks, which persisted after 12 weeks and tended to be present after 26 weeks (week 26 vs baseline: liraglutide -52 ± 128 kcal/day; P = 0.071, placebo +44 ± 144 kcal/day; P = 0.153, between group P = 0.057).","[{'ForeName': 'Huub J', 'Initials': 'HJ', 'LastName': 'van Eyk', 'Affiliation': 'Dept. Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, the Netherlands; Einthoven Laboratory for Experimental Vascular Medicine, LUMC, Leiden, the Netherlands. Electronic address: H.J.van_Eyk@lumc.nl.'}, {'ForeName': 'Elisabeth H M', 'Initials': 'EHM', 'LastName': 'Paiman', 'Affiliation': 'Dept. Radiology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Dept. Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, the Netherlands; Dept. Radiology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'IJzermans', 'Affiliation': 'Dept. Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, the Netherlands; Einthoven Laboratory for Experimental Vascular Medicine, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Kleiburg', 'Affiliation': 'Dept. Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, the Netherlands; Einthoven Laboratory for Experimental Vascular Medicine, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Tim G W', 'Initials': 'TGW', 'LastName': 'Boers', 'Affiliation': 'Dept. Radiology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Eline J', 'Initials': 'EJ', 'LastName': 'Rappel', 'Affiliation': 'Dept. Radiology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Jedrzej', 'Initials': 'J', 'LastName': 'Burakiewicz', 'Affiliation': 'Dept. Radiology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Hermien E', 'Initials': 'HE', 'LastName': 'Kan', 'Affiliation': 'Dept. Radiology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Dept. Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Dept. Radiology, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Dept. Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, the Netherlands; Einthoven Laboratory for Experimental Vascular Medicine, LUMC, Leiden, the Netherlands.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Dept. Medicine, Div. Endocrinology, Leiden University Medical Center (LUMC), Leiden, the Netherlands; Einthoven Laboratory for Experimental Vascular Medicine, LUMC, Leiden, the Netherlands.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.12.005']
282,32132264,The Right Temporoparietal Junction Is Causally Associated with Embodied Perspective-taking.,"A prominent theory claims that the right temporoparietal junction (rTPJ) is especially associated with embodied processes relevant to perspective-taking. In the present study, we use high-definition transcranial direct current stimulation to provide evidence that the rTPJ is causally associated with the embodied processes underpinning perspective-taking. Eighty-eight young human adults were stratified to receive either rTPJ or dorsomedial PFC anodal high-definition transcranial direct current stimulation in a sham-controlled, double-blind, repeated-measures design. Perspective-tracking (line-of-sight) and perspective-taking (embodied rotation) were assessed using a visuo-spatial perspective-taking task that required understanding what another person could see or how they see it, respectively. Embodied processing was manipulated by positioning the participant in a manner congruent or incongruent with the orientation of an avatar on the screen. As perspective-taking, but not perspective-tracking, is influenced by bodily position, this allows the investigation of the specific causal role for the rTPJ in embodied processing. Crucially, anodal stimulation to the rTPJ increased the effect of bodily position during perspective-taking, whereas no such effects were identified during perspective-tracking, thereby providing evidence for a causal role for the rTPJ in the embodied component of perspective-taking. Stimulation to the dorsomedial PFC had no effect on perspective-tracking or taking. Therefore, the present study provides support for theories postulating that the rTPJ is causally involved in embodied cognitive processing relevant to social functioning. SIGNIFICANCE STATEMENT  The ability to understand another's perspective is a fundamental component of social functioning. Adopting another perspective is thought to involve both embodied and nonembodied processes. The present study used high-definition transcranial direct current stimulation (HD-tDCS) and provided causal evidence that the right temporoparietal junction is involved specifically in the embodied component of perspective-taking. Specifically, HD-tDCS to the right temporoparietal junction, but not another hub of the social brain (dorsomedial PFC), increased the effect of body position during perspective-taking, but not tracking. This is the first causal evidence that HD-tDCS can modulate social embodied processing in a site-specific and task-specific manner.",2020,Stimulation to the dmPFC had no effect on perspective tracking or taking.,['Eighty-eight young human adults'],"['right temporoparietal junction (rTPJ', 'HD-tDCS', 'high-definition transcranial direct current stimulation (HD-tDCS', 'rTPJ', 'Perspective tracking (line-of-sight) and perspective taking (embodied rotation) were assessed using a visuo-spatial perspective taking (VPT) task', 'rTPJ or dorsomedial prefrontal (dmPFC) anodal HD-tDCS']",[],"[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",[],88.0,0.0306805,Stimulation to the dmPFC had no effect on perspective tracking or taking.,"[{'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029, a.martin11@uq.edu.au.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kessler', 'Affiliation': 'Aston Neuroscience Institute, School of Life and Health Sciences, Aston University, Birmingham, United Kingdom B4 7ET, and.'}, {'ForeName': 'Shena', 'Initials': 'S', 'LastName': 'Cooke', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2637-19.2020']
283,31986357,Vascular endothelial growth factor in bipolar depression: A potential biomarker for diagnosis and treatment outcome prediction.,"BACKGROUND


Vascular Endothelial Growth Factor (VEGF) has been implicated in the neurotrophic model of depression. We explored the potential role of VEGF in the pathophysiology of bipolar depression and potential utility as a diagnostic or outcome predictive biomarker.
METHODS


In a double-blind study, treatment-resistant bipolar depressed patients received Escitalopram and were randomized to receive add-on Celecoxib (26 participants) or Placebo (21 participants). There were 32 healthy controls. Plasma levels of VEGF were determined at three timepoints over eight weeks.
RESULTS


Bipolar patients had significantly higher VEGF levels at baseline compared to healthy controls. Logistic regression analysis revealed that the AUC is 0.67 and the VEGF cut point is 8.21. At all timepoints, patients receiving Celecoxib had comparable VEGF levels to those receiving Placebo. VEGF levels did not change significantly over time. Baseline VEGF was a poor predictor of treatment response with an AUC of 0.53.
CONCLUSIONS


The increased VEGF in bipolar depression agrees with similar findings in major depressive disorder. A high VEGF level tended to accurately predict bipolar disorder, with apparent differential VEGF expression. Baseline VEGF did not predict treatment response, and levels did not change with treatment. Plasma VEGF may have diagnostic utility and guide personalized treatment.",2020,"At all timepoints, patients receiving Celecoxib had comparable VEGF levels to those receiving Placebo.","['bipolar depression', '32 healthy controls', 'treatment-resistant bipolar depressed patients received']","['Placebo', 'VEGF', 'Escitalopram', 'Celecoxib']","['VEGF levels', 'Plasma levels of VEGF']","[{'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",32.0,0.210607,"At all timepoints, patients receiving Celecoxib had comparable VEGF levels to those receiving Placebo.","[{'ForeName': 'Monica Feliz R', 'Initials': 'MFR', 'LastName': 'Castillo', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edberg', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoppensteadt', 'Affiliation': 'Hemostasis and Thrombosis Research Laboratories, Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Hemostasis and Thrombosis Research Laboratories, Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Martin', 'Affiliation': 'Clinical Research Office, Biostatistics Collaborative Core, Loyola University Chicago, Maywood, Illinois, USA.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Halaris', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA. Electronic address: ahalaris@lumc.edu.'}]",Psychiatry research,['10.1016/j.psychres.2020.112781']
284,31852492,Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial.,"BACKGROUND


Breast cancer is the most common cancer and the leading cause of cancer mortality among Latinas. As more is learned about the association between mammographic breast density (MBD) and breast cancer risk, a number of U.S. states adopted legislation and now a federal law mandates written notification of MBD along with mammogram results. These notifications vary in content and readability, though, which may limit their effectiveness and create confusion or concern, especially among women with low health literacy or barriers to screening. The purpose of this study is to determine whether educational enhancement of MBD notification results in increased knowledge, decreased anxiety, and adherence to continued mammography screening among Latina women in a limited-resources setting.
METHODS


Latinas LEarning About Density (LLEAD) is a randomized clinical trial (RCT) comparing the impact of three notification approaches on behavioral and psychological outcomes in Latina women. Approximately 2000 Latinas undergoing screening mammography in a safety-net community clinic will be randomized 1:1:1 to mailed notification (usual care); mailed notification plus written educational materials (enhanced); or mailed notification, written educational materials, plus verbal explanation by a promotora (interpersonal). The educational materials and verbal explanations are available in Spanish or English. Mechanisms through which written or verbal information influences future screening motivation and behavior will be examined, as well as moderating factors such as depression and worry about breast cancer, which have been linked to diagnostic delays among Latinas. The study includes multiple psychological measures (anxiety, depression, knowledge about MBD, perceived risk of breast cancer, worry, self-efficacy) and behavioral outcomes (continued adherence to mammography). Measurement time points include enrollment, 2-4 weeks post-randomization, and 1 and 2 years post-randomization. Qualitative inquiry related to process and outcomes of the interpersonal arm and cost analysis related to its implementation will be undertaken to understand the intervention's delivery and transferability.
DISCUSSION


Legislation mandating written MBD notification may have unintended consequences on behavioral and psychological outcomes, particularly among Latinas with limited health literacy and resources. This study has implications for cancer risk communication and will offer evidence on the potential of generalizable educational strategies for delivering information on breast density to Latinas in limited-resource settings.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02910986. Registered on 21 September 2016. Items from the WHO Trial Registration Data Set can be found in this protocol.",2019,"This study has implications for cancer risk communication and will offer evidence on the potential of generalizable educational strategies for delivering information on breast density to Latinas in limited-resource settings.
","['Approximately 2000 Latinas undergoing screening mammography in a safety-net community clinic', 'Latina women in a limited-resources setting', 'Latina women']","['Latinas LEarning About Density (LLEAD', 'mailed notification (usual care); mailed notification plus written educational materials (enhanced); or mailed notification, written educational materials, plus verbal explanation by a promotora (interpersonal']","['behavioral and psychological outcomes', 'multiple psychological measures (anxiety, depression, knowledge about MBD, perceived risk of breast cancer, worry, self-efficacy) and behavioral outcomes (continued adherence to mammography']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0203028', 'cui_str': 'Screening mammography (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",,0.0641577,"This study has implications for cancer risk communication and will offer evidence on the potential of generalizable educational strategies for delivering information on breast density to Latinas in limited-resource settings.
","[{'ForeName': 'Bhavika K', 'Initials': 'BK', 'LastName': 'Patel', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Ridgeway', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ghosh', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Rhodes', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Borah', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Vera J', 'Initials': 'VJ', 'LastName': 'Suman', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Norman', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Jewett', 'Affiliation': 'Mountain Park Health Center, Phoenix, AZ, USA.'}, {'ForeName': 'Davinder', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Mountain Park Health Center, Phoenix, AZ, USA.'}, {'ForeName': 'Celine M', 'Initials': 'CM', 'LastName': 'Vachon', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. vachon.celine@mayo.edu.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Radecki Breitkopf', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}]",Trials,['10.1186/s13063-019-3939-6']
285,32008913,Effect of fatty fish or nut consumption on concentrations of persistent organic pollutants in overweight or obese men and women: A randomized controlled clinical trial.,"BACKGROUND AND AIMS


While excess energy intake and physical inactivity constitute the obvious causes of body fat accumulation, persistent organic pollutants (POPs) are novel factors that have been linked to cardiometabolic disorders. Major sources of POPs are animal fats including fatty fish. Given the putative protective effects of fish on cardiovascular disease, we explored whether high consumption of fatty fish increased serum concentrations of POPs.
METHODS AND RESULTS


Men and women aged 35-70 years with body mass index between 25 and 38 kg/m 2  and at least 1 cardiometabolic component were randomized to high intakes of fatty fish (mostly farmed salmon, ∼630 g/week; n = 45), high intakes of nuts (∼200 g/week; n = 42) or a control group following their usual diet but restricting fatty fish and nuts for 6 months (n = 44). Concentrations of 15 POPs (5 organochlorinated compounds, 2 dioxin-like polychlorinated biphenyls and 8 non-dioxin-like polychlorinated biphenyls) and cardiometabolic risk factors were measured at baseline and end of the study. Results showed that changes in concentrations of individual and classes of POPs did not differ between the dietary groups and controls (p > 0.05). Among cardiometabolic risk factors HDL-cholesterol increased in the fatty fish group compared to controls (+0.10 mmol/L, CI (0.05-0.20); p = 0.005) while no changes were observed in the group consuming nuts.
CONCLUSION


Fatty fish consumption for 6 months did not increase the serum concentrations of POPs in individuals with overweight or obesity and metabolic risk. While this finding appears reassuring regarding short-term intakes of farmed salmon, long term variations in POPs in adipose stores require further study.",2020,"Among cardiometabolic risk factors HDL-cholesterol increased in the fatty fish group compared to controls (+0.10 mmol/L, CI (0.05-0.20); p = 0.005) while no changes were observed in the group consuming nuts.
","['individuals with overweight or obesity and metabolic risk', 'overweight or obese men and women', 'Men and women aged 35-70 years with body mass index between 25 and 38\xa0kg/m 2  and at least 1 cardiometabolic component']","['fatty fish or nut consumption', 'Fatty fish consumption', 'high intakes of fatty fish (mostly farmed salmon, ∼630\xa0g/week; n\xa0=\xa045), high intakes of nuts (∼200\xa0g/week; n\xa0=\xa042) or a control group following their usual diet but restricting fatty fish and nuts']","['serum concentrations of POPs', 'cardiometabolic risk factors HDL-cholesterol', 'concentrations of individual and classes of POPs', 'cardiometabolic risk factors']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557759', 'cui_str': 'Farmland'}, {'cui': 'C0036110', 'cui_str': 'Salmon'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",,0.0870772,"Among cardiometabolic risk factors HDL-cholesterol increased in the fatty fish group compared to controls (+0.10 mmol/L, CI (0.05-0.20); p = 0.005) while no changes were observed in the group consuming nuts.
","[{'ForeName': 'Sasa', 'Initials': 'S', 'LastName': 'Dusanov', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway. Electronic address: sasdus@ous-hf.no.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Svendsen', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway; Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Ruzzin', 'Affiliation': 'Department of Biological Sciences, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kiviranta', 'Affiliation': 'National Institute for Health and Welfare, Department of Health Security, Kuopio, Finland.'}, {'ForeName': 'Hanne L', 'Initials': 'HL', 'LastName': 'Gulseth', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway; Department of Chronic Diseases and Ageing, Norwegian Instiute of Public Health, Oslo, Norway.'}, {'ForeName': 'Tor O', 'Initials': 'TO', 'LastName': 'Klemsdal', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Tonstad', 'Affiliation': 'Section for Preventive Cardiology, Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.11.006']
286,31113841,Pharmacodynamic and Clinical Results from a Phase I/II Study of the HSP90 Inhibitor Onalespib in Combination with Abiraterone Acetate in Prostate Cancer.,"PURPOSE


Onalespib is a potent, fragment-derived second-generation HSP90 inhibitor with preclinical activity in castration-resistant prostate cancer (CPRC) models. This phase I/II trial evaluated onalespib in combination with abiraterone acetate (AA) and either prednisone or prednisolone (P) in men with CRPC progressing on AA/P.
PATIENTS AND METHODS


Patients with progressing CRPC were randomly assigned to receive 1 of 2 regimens of onalespib combined with AA/P. Onalespib was administered as intravenous infusion starting at 220 mg/m 2  once weekly for 3 of 4 weeks (regimen 1); or at 120 mg/m 2  on day 1 and day 2 weekly for 3 of 4 weeks (regimen 2). Primary endpoints were response rate and safety. Secondary endpoints included evaluation of androgen receptor (AR) depletion in circulating tumor cells (CTC) and in fresh tumor tissue biopsies.
RESULTS


Forty-eight patients were treated with onalespib in combination with AA/P. The most common ≥grade 3 toxicities related to onalespib included diarrhea (21%) and fatigue (13%). Diarrhea was dose limiting at 260 and 160 mg/m 2  for regimens 1 and 2, respectively. Transient decreases in CTC counts and AR expression in CTC were observed in both regimens. HSP72 was significantly upregulated following onalespib treatment, but only a modest decrease in AR and GR was shown in paired pre- and posttreatment tumor biopsy samples. No patients showed an objective or PSA response.
CONCLUSIONS


Onalespib in combination with AA/P showed mild evidence of some biological effect; however, this effect did not translate into clinical activity, hence further exploration of this combination was not justified.",2019,"HSP72 was significantly upregulated following onalespib treatment, but only a modest decrease in AR and GR was shown in paired pre- and posttreatment tumor biopsy samples.","['Prostate Cancer', 'men with CRPC progressing on AA/P. Patients and Methods:  Patients with progressing CRPC', 'Results:  Forty-eight patients were treated with onalespib in combination with AA/P']","['Abiraterone Acetate', 'abiraterone acetate (AA) and either prednisone or prednisolone (P', 'onalespib combined with AA/P. Onalespib']","['Diarrhea', 'objective or PSA response', 'evaluation of androgen receptor (AR) depletion in circulating tumor cells (CTC) and in fresh tumor tissue biopsies', 'CTC counts and AR expression in CTC', 'HSP72', 'AR and GR', 'response rate and safety', 'diarrhea']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2975147', 'cui_str': '(2,4-dihydroxy-5-isopropylphenyl)-(5-(4-methylpiperazin-1-ylmethyl)-1,3-dihydroisoindol-2-yl)methanone'}]","[{'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C2975147', 'cui_str': '(2,4-dihydroxy-5-isopropylphenyl)-(5-(4-methylpiperazin-1-ylmethyl)-1,3-dihydroisoindol-2-yl)methanone'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0027625', 'cui_str': 'Circulating Tumor Cells'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",48.0,0.0502832,"HSP72 was significantly upregulated following onalespib treatment, but only a modest decrease in AR and GR was shown in paired pre- and posttreatment tumor biopsy samples.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Slovin', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, United Kingdom.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Picus', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Ferraldeschi', 'Affiliation': 'Astex Therapeutics Ltd., Cambridge, United Kingdom.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': 'The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Flohr', 'Affiliation': 'The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Riisnaes', 'Affiliation': 'The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Chihche', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Astex Pharmaceuticals, Inc., Pleasanton, California.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Keer', 'Affiliation': 'Astex Pharmaceuticals, Inc., Pleasanton, California.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Oganesian', 'Affiliation': 'Astex Pharmaceuticals, Inc., Pleasanton, California.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Workman', 'Affiliation': 'The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research and Royal Marsden Hospital, London, United Kingdom. johann.de-bono@icr.ac.uk.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3212']
287,31567166,High-Definition Chromoendoscopy Versus High-Definition White Light Colonoscopy for Neoplasia Surveillance in Ulcerative Colitis: A Randomized Controlled Trial.,"OBJECTIVES


Although chromoendoscopy is currently the recommended mode of surveillance in patients with long-standing ulcerative colitis, it is technically challenging and requires a long procedure time. The aim of this study was to compare the dysplasia detection rate of high-definition white light endoscopy with random biopsy (HDWL-R) vs high-definition chromoendoscopy with targeted biopsy (HDCE-T).
METHODS


This was a multicenter, prospective randomized controlled trial involving 9 tertiary teaching hospitals in South Korea. A total of 210 patients with long-standing ulcerative colitis were randomized to undergo either the HDWL-R group (n = 102) or HDCE-T group (n = 108). The detection rates of colitis-associated dysplasia (CAD) or all colorectal neoplasia from each trial arm were compared.
RESULTS


There was no significant difference in the CAD detection rate between HDCE-T and HDWL-R groups (4/102, 3.9% vs 6/108, 5.6%, P = 0.749). However, HDCE-T showed a trend toward improved colorectal neoplasia detection compared with HDWL-R (21/102, 20.6% vs 13/108, 12.0%, P = 0.093). The median (range) time for colonoscopy withdrawal between the 2 groups was similar (17.6 [7.0-43.3] minutes vs 16.5 [6.3-38.1] minutes; P=0.212; for HDWL-R and HDCE-T, respectively). The total number of biopsies was significantly larger in the HDWL-R group (34 [12-72]) compared with the HDCE-T group (9 [1-20]; P < 0.001).
DISCUSSION


On the basis of our prospective randomized controlled trial, HDCE-T was not superior to HDWL-R for detecting CADs.",2019,"The total number of biopsies was significantly larger in the HDWL-R group (34 [12-72]) compared with the HDCE-T group (9 [1-20]; P < 0.001).
","['9 tertiary teaching hospitals in South Korea', 'Ulcerative Colitis', '210 patients with long-standing ulcerative colitis', 'patients with long-standing ulcerative colitis']","['HDCE-T', 'High-Definition Chromoendoscopy', 'High-Definition White Light Colonoscopy', 'HDWL-R', 'high-definition white light endoscopy with random biopsy (HDWL-R) vs high-definition chromoendoscopy with targeted biopsy (HDCE-T']","['dysplasia detection rate', 'total number of biopsies', 'detection rates of colitis-associated dysplasia (CAD) or all colorectal neoplasia', 'colorectal neoplasia detection', 'median (range) time for colonoscopy withdrawal', 'CAD detection rate']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449807', 'cui_str': 'Number of biopsies (qualifier value)'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",210.0,0.150287,"The total number of biopsies was significantly larger in the HDWL-R group (34 [12-72]) compared with the HDCE-T group (9 [1-20]; P < 0.001).
","[{'ForeName': 'Dong-Hoon', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soo Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Eulji University School of Medicine, Eulji hospital, Seoul, Korea.'}, {'ForeName': 'Dong Il', 'Initials': 'DI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital, Seoul, Korea.'}, {'ForeName': 'Kang-Moon', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.""}, {'ForeName': 'Sung-Ae', 'Initials': 'SA', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang Hwan', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ja Seol', 'Initials': 'JS', 'LastName': 'Koo', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Ansan, Korea.'}, {'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Cheon', 'Affiliation': 'Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Suk-Kyun', 'Initials': 'SK', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jihun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hogeun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang-Ho', 'Initials': 'CH', 'LastName': 'Ryan Choi', 'Affiliation': 'Department of Gastroenterology & Hepatology, St. George Hospital, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000341']
288,31915861,Effects of short-term cannabidiol treatment on response to social stress in subjects at clinical high risk of developing psychosis.,"RATIONALE


Stress is a risk factor for psychosis and treatments which mitigate its harmful effects are needed. Cannabidiol (CBD) has antipsychotic and anxiolytic effects.
OBJECTIVES


We investigated whether CBD would normalise the neuroendocrine and anxiety responses to stress in clinical high risk for psychosis (CHR) patients.
METHODS


Thirty-two CHR patients and 26 healthy controls (HC) took part in the Trier Social Stress Test (TSST) and their serum cortisol, anxiety and stress associated with public speaking were estimated. Half of the CHR participants were on 600 mg/day of CBD (CHR-CBD) and half were on placebo (CHR-P) for 1 week.
RESULTS


One-way analysis of variance (ANOVA) revealed a significant effect of group (HC, CHR-P, CHR-CBD (p = .005) on cortisol reactivity as well as a significant (p = .003) linear decrease. The change in cortisol associated with experimental stress exposure was greatest in HC controls and least in CHR-P patients, with CHR-CBD patients exhibiting an intermediate response. Planned contrasts revealed that the cortisol reactivity was significantly different in HC compared with CHR-P (p = .003), and in HC compared with CHR-CBD (p = .014), but was not different between CHR-P and CHR-CBD (p = .70). Across the participant groups (CHR-P, CHR-CBD and HC), changes in anxiety and experience of public speaking stress (all p's < .02) were greatest in the CHR-P and least in the HC, with CHR-CBD participants demonstrating an intermediate level of change.
CONCLUSIONS


Our findings show that it is worthwhile to design further well powered studies which investigate whether CBD may be used to affect cortisol response in clinical high risk for psychosis patients and any effect this may have on symptoms.",2020,"Planned contrasts revealed that the cortisol reactivity was significantly different in HC compared with CHR-P (p = .003), and in HC compared with CHR-CBD (p = .014), but was not different between CHR-P and CHR-CBD (p = .70).","['subjects at clinical high risk of developing psychosis', 'Thirty-two CHR patients and 26 healthy controls (HC) took part in the', 'clinical high risk for psychosis (CHR) patients']","['short-term cannabidiol treatment', 'CBD']","['response to social stress', 'cortisol reactivity', 'CHR-P, CHR-CBD', 'Trier Social Stress Test (TSST) and their serum cortisol, anxiety and stress associated with public speaking', 'anxiety and experience of public speaking stress']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]",32.0,0.0200395,"Planned contrasts revealed that the cortisol reactivity was significantly different in HC compared with CHR-P (p = .003), and in HC compared with CHR-CBD (p = .014), but was not different between CHR-P and CHR-CBD (p = .70).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Appiah-Kusi', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, PO Box 63, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Petros', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, PO Box 63, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, PO Box 63, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colizzi', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, PO Box 63, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Bossong', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, PO Box 63, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Valmaggia', 'Affiliation': ""Department of Psychology, IoPPN, King's College London, London, PO Box 77, UK.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mondelli', 'Affiliation': 'National Institute for Health Research, Biomedical Research Centre, London, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, PO Box 63, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, PO Box 63, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK. sagnik.2.bhattacharyya@kcl.ac.uk.""}]",Psychopharmacology,['10.1007/s00213-019-05442-6']
289,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES


Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.
METHODS


The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score).
RESULTS


56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously.
CONCLUSION


XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2020,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION


XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017']
290,31895638,Influence of Perfluorohexyloctane Eye Drops on Tear Film Thickness in Patients with Mild to Moderate Dry Eye Disease: A Randomized Controlled Clinical Trial.,"Purpose:  The aim of this mechanistic clinical study was to explore the effect of water-free perfluorohexyloctane eye drops on tear film thickness (TFT) in patients with dry eye disease (DED).  Methods:  Forty-eight patients with mild to moderate DED participated in this randomized, single-masked, observer-blinded parallel group study in a 1:1 ratio to receive either perfluorohexyloctane or unpreserved 0.9% saline solution (Hydrabak ® , Thea, France) eye drops 4 times daily in both eyes for 4 weeks. A custom-built ultrahigh-resolution optical coherence tomography system was used to measure TFT. Furthermore, evaluation of lipid layer thickness (LLT) and noninvasive tear film breakup time, as well as standard clinical tests for signs and symptoms of DED were performed.  Results:  Mean TFT and LLT at baseline were comparable between the 2 treatment groups. After a single drop instillation, perfluorohexyloctane eye drops temporarily increased TFT immediately. After multiple dosing, perfluorohexyloctane eye drops gradually increased TFT over time with a maximum effect at the end of the study (least square mean difference: 6.42%;  P  = 0.0142 at week 4). LLT values measured before drop instillation showed a more prominent increase in LLT for perfluorohexyloctane eye drops (13.36% ± 26.33% vs. 3.21% ± 28.65%). All other parameters got better in both treatment groups with no statistical difference between groups.  Conclusions:  These results demonstrate that perfluorohexyloctane eye drops increase TFT as well as LLT over time. These tear film reestablishing attributes are in line with the mode of action of perfluorohexyloctane eye drops to avoid evaporation through stabilization of the lipid layer.",2020,All other parameters got better in both treatment groups with no statistical difference between groups.  ,"['Methods:  Forty-eight patients with mild to moderate DED', 'Patients with Mild to Moderate Dry Eye Disease', 'patients with dry eye disease (DED']","['perfluorohexyloctane or unpreserved 0.9% saline solution (Hydrabak ® , Thea, France', 'water-free perfluorohexyloctane eye drops', 'Perfluorohexyloctane Eye Drops', 'perfluorohexyloctane']","['lipid layer thickness (LLT) and noninvasive tear film breakup time', 'TFT', 'tear film thickness (TFT', 'Tear Film Thickness', 'LLT values', 'LLT', 'Mean TFT and LLT at baseline']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0766224', 'cui_str': 'perfluorohexyloctane'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0543468', 'cui_str': 'Thea'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",48.0,0.0548683,All other parameters got better in both treatment groups with no statistical difference between groups.  ,"[{'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Schmidl', 'Affiliation': 'Department of Clinical Pharmacology and Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Bata', 'Affiliation': 'Department of Clinical Pharmacology and Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Szegedi', 'Affiliation': 'Department of Clinical Pharmacology and Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Aranha Dos Santos', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Stegmann', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Fondi', 'Affiliation': 'Department of Clinical Pharmacology and Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Krösser', 'Affiliation': 'Department of Clinical Development, Novaliq GmbH, Heidelberg, Germany.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Werkmeister', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Schmetterer', 'Affiliation': 'Department of Clinical Pharmacology and Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Garhöfer', 'Affiliation': 'Department of Clinical Pharmacology and Medical University of Vienna, Vienna, Austria.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0092']
291,31602966,"Efficacy of trospium for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study.","BACKGROUND


Catheter-related bladder discomfort (CRBD) is a frequent complaint after awakening from anesthesia in patients receiving perioperative bladder catheterization. Overactive bladder (OAB) and CRBD show similar symptoms; thus, drugs used for the management of OAB influence symptoms of CRBD. Trospium chloride has been found effective in managing resistant cases of OAB. We evaluated the efficacy of oral trospium on CRBD in the postoperative period.
METHODS


Sixty-four male and female adult patients, with planned spinal surgery and requiring urinary bladder catheterization, were randomly divided into two groups of 32 each. Group T patients received 60 mg extended-release oral trospium (extended-release) 1 h before induction of anesthesia and Group C patients received a similar-looking placebo. The anesthetic technique was identical in both groups. The CRBD score was evaluated in the postoperative ward using a 4-point scale (1 = no discomfort, 2 = mild, 3 = moderate, 4 = severe). Readings were recorded on arrival (0 h), and 1 h, 2 h, and 6 h postoperatively. All patients received fentanyl for postoperative pain relief.
RESULTS


The incidence of CRBD was significantly higher in group C than in group T at 0 h (66% vs 22%, P=0.001) and 1 h postoperatively (72% vs 28%, P=0.001). The incidence of moderate to severe CRBD was higher in group C at postoperative 2 h (82% vs 14%, P=0.004). There was no significant difference in postoperative fentanyl requirements.
CONCLUSIONS


Pretreatment with 60 mg ER trospium reduced the incidence and severity of CRBD in the early postoperative period.",2020,"The incidence of moderate to severe CRBD was higher in group C at postoperative 2 h (82% vs 14%, p=0.004).","['patients receiving perioperative bladder catheterization', 'catheter-related bladder discomfort', 'Methods\n\n\nSixty-four male and female adult patients']","['Trospium chloride', 'oral trospium 60 mg ER (extended-release) 1 h before induction of anesthesia and Group C patients received a similar looking placebo', 'trospium', '\n\n\nCatheter related bladder discomfort (CRBD', 'placebo', 'planned for spine surgery and requiring catheterization of urinary bladder', 'oral trospium', 'fentanyl']","['Overactive bladder (OAB', 'incidence of CRBD', 'incidence and severity of CRBD', 'postoperative fentanyl requirements', 'CRBD score', 'incidence of moderate to severe CRBD', 'postoperative pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1970989', 'cui_str': 'Insertion of catheter into urinary bladder'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0077408', 'cui_str': 'trospium chloride'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0772089', 'cui_str': 'Trospium'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1970989', 'cui_str': 'Insertion of catheter into urinary bladder'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",64.0,0.0619687,"The incidence of moderate to severe CRBD was higher in group C at postoperative 2 h (82% vs 14%, p=0.004).","[{'ForeName': 'Vinit Kumar', 'Initials': 'VK', 'LastName': 'Srivastava', 'Affiliation': 'Department of Anesthesiology, Apollo Hospitals Bilaspur, Chhattisgarh, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Anesthesiology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Sweta Anil', 'Initials': 'SA', 'LastName': 'Deshmukh', 'Affiliation': 'Department of Anesthesiology, Apollo Hospitals Bilaspur, Chhattisgarh, India.'}, {'ForeName': 'Febin', 'Initials': 'F', 'LastName': 'Noushad', 'Affiliation': 'Department of Anesthesiology, Apollo Hospitals Bilaspur, Chhattisgarh, India.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Anesthesiology, Apollo Hospitals Bilaspur, Chhattisgarh, India.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Neurosurgery, Apollo Hospitals Bilaspur, Chhattisgarh, India.'}]",Korean journal of anesthesiology,['10.4097/kja.19198']
292,31603998,Effects of Estrogen Replacement on Bone Geometry and Microarchitecture in Adolescent and Young Adult Oligoamenorrheic Athletes: A Randomized Trial.,"Oligoamenorrheic athletes (OAs) have lower bone mineral density (BMD) and greater impairment of bone microarchitecture, and therefore higher fracture rates compared to eumenorrheic athletes. Although improvements in areal BMD (aBMD; measured by dual-energy X-ray absorptiometry) in OAs have been demonstrated with transdermal estrogen treatment, effects of such treatment on bone microarchitecture are unknown. Here we explore effects of transdermal versus oral estrogen versus no estrogen on bone microarchitecture in OA. Seventy-five OAs (ages 14 to 25 years) were randomized to (i) a 100-μg 17β-estradiol transdermal patch (PATCH) administered continuously with 200 mg cyclic oral micronized progesterone; (ii) a combined 30 μg ethinyl estradiol and 0.15 mg desogestrel pill (PILL); or (iii) no estrogen/progesterone (NONE) and were followed for 12 months. Calcium (≥1200 mg) and vitamin D (800 IU) supplements were provided to all. Bone microarchitecture was assessed using high-resolution peripheral quantitative CT at the distal tibia and radius at baseline and 1 year. At baseline, randomization groups did not differ by age, body mass index, percent body fat, duration of amenorrhea, vitamin D levels, BMD, or bone microarchitecture measurements. After 1 year of treatment, at the distal tibia there were significantly greater increases in total and trabecular volumetric BMD (vBMD), cortical area and thickness, and trabecular number in the PATCH versus PILL groups. Trabecular area decreased significantly in the PATCH group versus the PILL and NONE groups. Less robust differences between groups were seen at the distal radius, where percent change in cortical area and thickness was significantly greater in the PATCH versus PILL and NONE groups, and changes in cortical vBMD were significantly greater in the PATCH versus PILL groups. In conclusion, in young OAs, bone structural parameters show greater improvement after 1 year of treatment with transdermal 17β-estradiol versus ethinyl estradiol-containing pills, particularly at the tibia. © 2019 American Society for Bone and Mineral Research.",2020,"Less robust differences between groups were seen at the distal radius, where percent change in cortical area and thickness was significantly greater in the PATCH vs. PILL and NONE groups, and changes in cortical vBMD were significantly greater in the PATCH vs. PILL groups.","['Seventy-five OA (ages 14-25\u2009years', 'Oligo-amenorrheic athletes (OA', 'OA', 'young oligo-amenorrheic athletes', 'Adolescent and Young Adult Oligo-amenorrheic Athletes']","['transdermal 17β-estradiol vs. ethinyl estradiol', 'vitamin D (800 IU', 'Calcium', 'Estrogen Replacement', '17β-estradiol transdermal patch (PATCH) administered continuously with 200 mg cyclic oral micronized progesterone, (ii) a combined 30 mcg ethinyl estradiol and 0.15 mg desogestrel pill (PILL), or (iii', 'transdermal vs. oral estrogen vs. no estrogen']","['body fat, duration of amenorrhea, vitamin D levels, BMD, or bone microarchitecture measurements', 'Trabecular area', 'bone mineral density (BMD', 'areal BMD (aBMD', 'Bone Geometry and Microarchitecture', 'cortical area and thickness', 'cortical vBMD', 'fracture rates', 'total and trabecular volumetric BMD (vBMD), cortical area and thickness, and trabecular number']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1137305', 'cui_str': 'oligo(caprolactone)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0086258', 'cui_str': 'Estrogen Replacements'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C3208700', 'cui_str': 'Desogestrel Pill'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",75.0,0.0577015,"Less robust differences between groups were seen at the distal radius, where percent change in cortical area and thickness was significantly greater in the PATCH vs. PILL and NONE groups, and changes in cortical vBMD were significantly greater in the PATCH vs. PILL groups.","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Ackerman', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vibha', 'Initials': 'V', 'LastName': 'Singhal', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Slattery', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kamryn T', 'Initials': 'KT', 'LastName': 'Eddy', 'Affiliation': 'Eating Disorders Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Bouxsein', 'Affiliation': 'Center for Advanced Orthopedic Studies, Beth Israel Deaconess Medical Center, Division of Endocrinology, Massachusetts General Hospital, and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klibanski', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3887']
293,31636242,Neuromuscular blockade reversal with sugammadex versus pyridostigmine/glycopyrrolate in laparoscopic cholecystectomy: a randomized trial of effects on postoperative gastrointestinal motility.,"BACKGROUND


Acetylcholinesterase inhibitors (e.g., pyridostigmine bromide) are used for neuromuscular blockade (NMB) reversal in patients undergoing surgery under general anesthesia (GA). Concurrent use of anticholinergic agents (e.g., glycopyrrolate) decreases cholinergic side effects but can impede bowel movements. Sugammadex has no cholinergic effects; its use modifies recovery of gastrointestinal (GI) motility following laparoscopic cholecystectomy compared to pyridostigmine/glycopyrrolate. This study evaluated the contribution of sugammadex to the recovery of GI motility compared with pyridostigmine and glycopyrrolate.
METHODS


We conducted a prospective study of patients who underwent laparoscopic cholecystectomy. Patients were randomly allocated to the experimental group (sugammadex, Group S) or control group (pyridostigmine-glycopyrrolate, Group P). After anesthesia (propofol and rocuronium, and 2% sevoflurane), recovery was induced by injection of sugammadex or a pyridostigmine-glycopyrrolate mixture. As a primary outcome, patients recorded the time of their first passage of flatus ('gas-out time') and defecation. The secondary outcome was stool types.
RESULTS


One-hundred and two patients participated (Group S, 49; Group P, 53). Mean time from injection of NMB reversal agents to gas-out time was 15.03 (6.36-20.25) h in Group S and 20.85 (16.34-25.86) h in Group P (P = 0.001). Inter-group differences were significant. Time until the first defecation as well as types of stools was not significantly different.
CONCLUSIONS


Sugammadex after laparoscopic cholecystectomy under GA resulted in an earlier first postoperative passage of flatus compared with the use of a mixture of pyridostigmine and glycopyrrolate. These findings suggest that the use of sugammadex has positive effects on the recovery of GI motility.",2020,Sugammadex has no cholinergic effects; its use modifies recovery of gastrointestinal (GI) motility following laparoscopic cholecystectomy compared to pyridostigmine/glycopyrrolate.,"['patients who underwent', '102 patients participated (Group S, 49 and Group P, 53', 'laparoscopic cholecystectomy', 'patients undergoing surgery under general anesthesia (GA']","['anticholinergic agents (e.g., glycopyrrolate', 'Sugammadex', 'anesthesia (propofol and rocuronium, 2% sevoflurane', 'pyridostigmine/glycopyrrolate', 'experimental group (sugammadex, Group S) or control group (pyridostigmine-glycopyrrolate', 'sugammadex versus pyridostigmine/glycopyrrolate', 'laparoscopic cholecystectomy', 'pyridostigmine and glycopyrrolate', '\n\n\nAcetylcholinesterase inhibitors (e.g., pyridostigmine bromide', 'pyridostigmine-glycopyrrolate mixture']","['GI motility', 'time until the first defecation or the types of stools', 'cholinergic side effects', 'recovery of postoperative GI motility', 'Mean time from injection of NMB reversal agents to gas-out time', 'gastrointestinal (GI) motility', 'time of their first passage of flatus (""gas-out time"") and defecation', 'stool types']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C4521949', 'cui_str': 'Acetylcholinesterase inhibitor (disposition)'}, {'cui': 'C0034262', 'cui_str': 'Pyridostigmine Bromide'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0242893', 'cui_str': 'Cholinergics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",102.0,0.0780067,Sugammadex has no cholinergic effects; its use modifies recovery of gastrointestinal (GI) motility following laparoscopic cholecystectomy compared to pyridostigmine/glycopyrrolate.,"[{'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Daegu Fatima Hospital, Daegu, Korea.'}, {'ForeName': 'Heeyun', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Daegu Fatima Hospital, Daegu, Korea.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Daegu Fatima Hospital, Daegu, Korea.'}, {'ForeName': 'Jihyang', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Daegu Fatima Hospital, Daegu, Korea.'}, {'ForeName': 'Kyeongyoon', 'Initials': 'K', 'LastName': 'Woo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Daegu Fatima Hospital, Daegu, Korea.'}, {'ForeName': 'Hyunkyum', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Daegu Fatima Hospital, Daegu, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.19360']
294,32266764,The impact of five nights of sleep restriction on emotional reactivity.,"An inadequate amount of sleep can negatively affect emotional processing, causing behavioural and neurofunctional changes. However, unlike the condition of total sleep deprivation, which has been extensively studied, the effects of prolonged sleep restriction have received less attention. In this study, we evaluated, for the first time, the effects of five nights of sleep restriction (5 hr a night) on emotional reactivity in healthy subjects. Forty-two subjects were selected to participate, over two consecutive weeks, in two experimental conditions in counterbalanced order. The subjects were tested the morning after five nights of regular sleep and after five consecutive nights of sleep restriction. During the test, participants evaluated valence and arousal of 90 images selected from the International Affective Picture System. The subjects perceived pleasant and neutral pictures in a more negative way in the sleep-restriction condition compared to the sleep condition. This effect survived after removing the contribution of mood changes. In contrast, there was no significant difference between conditions for ratings of unpleasant pictures. These results provide the first evidence that an inadequate amount of sleep for five consecutive nights determines an alteration of the evaluation of pleasant and neutral stimuli, imposing a negative emotional bias. Considering the pervasiveness of insufficient sleep in modern society, our results have potential implications for daily life, as well as in clinical settings.",2020,The subjects perceived pleasant and neutral pictures in a more negative way in the sleep-restriction condition compared to the sleep condition.,['healthy subjects'],['sleep restriction (5\xa0hr a night'],"['ratings of unpleasant pictures', 'emotional reactivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",42.0,0.0143547,The subjects perceived pleasant and neutral pictures in a more negative way in the sleep-restriction condition compared to the sleep condition.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tempesta', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Salfi', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'De Gennaro', 'Affiliation': 'Department of Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ferrara', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}]",Journal of sleep research,['10.1111/jsr.13022']
295,30624425,Randomized Controlled Trial of Acute Illness Educational Intervention in the Pediatric Emergency Department: Written Versus Application-Based Education.,"OBJECTIVES


The aim of this study was to determine the (1) feasibility, (2) demand, (3) acceptability, and (4) usefulness of a mobile health (mHealth) application (app) compared with a written intervention distributed in a pediatric emergency department (ED).
METHODS


This was a randomized controlled trial with parents of children 12 years or younger presenting to the ED for nonurgent complaints. Parents were randomized to receive a (1) low literacy pediatric health book with video, (2) pediatric mHealth app, (3) both 1 and 2, or (4) car-seat safety video and handout (control). Demand, acceptability, and usefulness were assessed at 1-, 3-, and 6-month follow-ups. Modified intention-to-treat analysis was completed for proportional data.
RESULTS


Ninety-eight parents completed randomization (83% approached). One or more follow-up was completed for 80.6% of parents. Only 57.1% downloaded the app. Parents used the app less than the book (35.1% vs 73.0%, P < 0.01), found the app to be harder to understand (26.0% vs 94.6%, P < 0.001) and less useful (37.8% vs 70.3%, P < 0.01), and were less likely to recommend the app to others (48.7% vs 100%, P < 0.01). No parent who received both book and app would prefer to have only the app; 88.9% of parents wanted either the book or both.
CONCLUSIONS


There was low demand for an mHealth app with parents who prefer, accept, and use the book more. Giving written health information to vulnerable populations in a pediatric ED has the capacity to empower parents with knowledge to care for a child and potentially decrease future nonurgent ED use with translation into a larger study.",2020,"Parents used the app less than the book (35.1% vs 73.0%, P < 0.01), found the app to be harder to understand (26.0% vs 94.6%, P < 0.001) and less useful (37.8% vs 70.3%, P < 0.01), and were less likely to recommend the app to others (48.7% vs 100%, P < 0.01).","['parents of children 12 years or younger presenting to the ED for nonurgent complaints', 'Pediatric Emergency Department']","['low literacy pediatric health book with video, (2) pediatric mHealth app, (3', 'Acute Illness Educational Intervention', 'mobile health (mHealth) application (app']","['Demand, acceptability, and usefulness']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.123141,"Parents used the app less than the book (35.1% vs 73.0%, P < 0.01), found the app to be harder to understand (26.0% vs 94.6%, P < 0.001) and less useful (37.8% vs 70.3%, P < 0.01), and were less likely to recommend the app to others (48.7% vs 100%, P < 0.01).","[{'ForeName': 'Bryn E', 'Initials': 'BE', 'LastName': 'Lepley', 'Affiliation': 'From the Medical College of Wisconsin.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Brousseau', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Meghan F', 'Initials': 'MF', 'LastName': 'May', 'Affiliation': 'From the Medical College of Wisconsin.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Morrison', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI.""}]",Pediatric emergency care,['10.1097/PEC.0000000000001719']
296,32265094,"Digital Monitoring of Sleep, Meals, and Physical Activity for Reducing Depression in Older Spousally-Bereaved Adults: A Pilot Randomized Controlled Trial.","OBJECTIVES


To evaluate the feasibility and acceptability of a behavioral intervention and explore its impact on depression symptom burden among older spousally-bereaved adults.
METHODS


Participants were age ≥60 years, bereaved ≤8 months, and at high risk for depression. Participants were randomized to 12 weeks of digital monitoring of sleep, meals, and physical activity; digital monitoring plus health coaching; or enhanced usual care and followed for 9 months for new-episode depression.
RESULTS


We enrolled 57 participants, 85% of eligible adults and 38% of all adults screened. We observed high levels of adherence in both digital monitoring (90%) and health coaching (92%); 88% of participants were retained. In linear mixed-effects models, depression symptoms significantly decreased, but the interaction between time and intervention was not significant.
CONCLUSION


A behavioral intervention that uses both digital monitoring and motivational health coaching is feasible and acceptable to older bereaved adults.",2020,We observed high levels of adherence in both digital monitoring (90%) and health coaching (92%); 88% of participants were retained.,"['We enrolled 57 participants, 85% of eligible adults and 38% of all adults screened', 'older bereaved adults', 'Participants were age ≥60 years, bereaved ≤8 months, and at high risk for depression', 'Older Spousally-Bereaved Adults', 'older spousally-bereaved adults']","['behavioral intervention', 'digital monitoring and motivational health coaching', 'digital monitoring of sleep, meals, and physical activity; digital monitoring plus health coaching; or enhanced usual care', 'Digital Monitoring of Sleep, Meals, and Physical Activity']","['depression symptoms', 'depression symptom burden']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",57.0,0.0537475,We observed high levels of adherence in both digital monitoring (90%) and health coaching (92%); 88% of participants were retained.,"[{'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Stahl', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA. Electronic address: Sarah.Stahl@pitt.edu.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Smagula', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mary Amanda', 'Initials': 'MA', 'LastName': 'Dew', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schulz', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA; University Center for Social and Urban Research, Pittsburgh, PA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh (SMA), Pittsburgh, PA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.013']
297,30852882,Ultrasound-guided bilateral quadratus lumborum block vs. intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled trial.,"BACKGROUND


Adequate pain control after cesarean section (CS) is crucial for mothers caring for newborns, and early ambulation to avoid thromboembolism and chronic abdominal and pelvic pain. This randomized controlled trial compared the efficacy of quadratus lumborum block (QLB) and intrathecal morphine (ITM) for analgesia after CS.
METHODS


Ninety women at ≥ 37 weeks pregnancy scheduled for elective CS were enrolled. All patients received spinal anesthesia and post-operative QLB. They were randomly allocated to Control (anesthesia: 0.1 ml saline, QLB: 24 ml saline), ITM (anesthesia: 0.1 mg morphine, QLB: 24 ml saline), or QLB groups (anesthesia: 0.1 ml saline, QLB: 24 ml 0.375% ropivacaine). Integrated analgesia score (IAS) and numerical rating scale (NRS) scores at rest and during movement, morphine requirements in the first 48 h, time to first morphine dose, and morphine-related side effects were recorded.
RESULTS


IASs and NRS scores at rest and during movement were significantly lower in QLB and ITM group than in Control group. Moreover, IASs and NRS scores at rest and during movement were lower in QLB group than in ITM group. Time to first morphine dose was significantly longer in QLB group than in ITM and Control group. Furthermore, morphine requirements in the first 48 h were significantly lower in QLB group than ITM and Control group. Incidence of morphine-related side effects was significantly higher in ITM group than in QLB and Control group.
CONCLUSIONS


QLB and ITM are effective analgesic regimens after CS. However, QLB provides better long-lasting analgesia and reduced total postoperative morphine consumption.",2020,"Results


IAS and NRS scores at rest and during movements were significantly less in QLB and ITM than CG.","['Ninety pregnant female patients with a gestation of 37 weeks or more scheduled for elective CS were enrolled into the study', 'postoperative analgesia after cesarean section']","['intrathecal morphine', 'control group (CG, 0.1ml saline added to spinal drug and 24ml saline for QL block), intrathecal morphine group (ITM, 0.1mg morphine added to spinal drug and 24ml saline for QL block), or QL block group (QLB, 0.1ml saline added to spinal drug and 24ml 0.375% ropivacaine', '\n\n\nAdequate pain control after cesarean section (CS', 'morphine', 'quadratus lumborum (QL) block and intrathecal morphine', 'Ultrasound guided bilateral quadratus lumborum block vs. intrathecal morphine', 'ITM', 'spinal anesthesia']","['QLB', 'Incidence of morphine related side effects', 'Integrated Analgesia Score (IAS), Numerical rating scale (NRS) at rest and during movement, morphine requirements in the first 48-h, time to first morphine dose, time to first ambulation, and morphine related side effects', 'IAS and NRS scores', 'time to first ambulation']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517455', 'cui_str': '0.375 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0908952', 'cui_str': 'iodoazidosalmeterol'}]",90.0,0.102841,"Results


IAS and NRS scores at rest and during movements were significantly less in QLB and ITM than CG.","[{'ForeName': 'Eman Ramadan', 'Initials': 'ER', 'LastName': 'Salama', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, FTanta University Faculty of Medicine, Tanta, Egypt.'}]",Korean journal of anesthesiology,['10.4097/kja.d.18.00269']
298,32101426,Lowering Urinary Phthalate Metabolite Concentrations among Children by Reducing Contaminated Dust in Housing Units: A Randomized Controlled Trial and Observational Study.,"Dust in homes can contain phthalates that may adversely affect child development, but whether residential interventions and dust removal can prevent children's exposure to phthalates is unknown. We quantified the influence of a residential lead hazard intervention and dust control on children's urinary phthalate metabolite concentrations. Between 2003 and 2006, The Health Outcomes and Measures of the Environment (HOME) Study randomized 355 pregnant women to receive an intervention to reduce either residential lead or injury hazards before delivery. We quantified eight urinary phthalate metabolites from 288 children at ages 1, 2, or 3 years (680 observations). During yearly home visits, we assessed dust accumulation in housing units. Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group. Monoethyl phthalate concentrations did not differ by group. In observational analyses, children living in housing units that appeared clean had 12-17% lower concentrations of these phthalate metabolites and monobenzyl phthalate, compared to children living in housing units with more dust accumulation. Features of this lead hazard intervention and measures to control dust may reduce children's exposure to phthalates found in building materials and household furnishings.",2020,"Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group.","['355 pregnant women to receive an', ""children's urinary phthalate metabolite concentrations"", '288 children at ages 1, 2, or 3 years (680 observations', 'children by reducing contaminated dust in housing units']","['residential lead hazard intervention and dust control', 'intervention to reduce either residential lead or injury hazards before delivery']","['Health Outcomes and Measures of the Environment', 'concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate', 'Monoethyl phthalate concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220894', 'cui_str': 'phthalate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220894', 'cui_str': 'phthalate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3659034', 'cui_str': 'monoethyl phthalate'}]",355.0,0.0726831,"Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group.","[{'ForeName': 'Clara G', 'Initials': 'CG', 'LastName': 'Sears', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Lanphear', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, Canada.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia 30329, United States.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, United States.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Skarha', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, United States.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Yolton', 'Affiliation': ""Department of Pediatrics, Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Braun', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}]",Environmental science & technology,['10.1021/acs.est.9b04898']
299,32187119,Enhanced mindfulness-based stress reduction in episodic migraine: a randomized clinical trial with magnetic resonance imaging outcomes.,"We aimed to evaluate the efficacy of an enhanced mindfulness-based stress reduction (MBSR+) vs stress management for headache (SMH). We performed a randomized, assessor-blind, clinical trial of 98 adults with episodic migraine recruited at a single academic center comparing MBSR+ (n = 50) with SMH (n = 48). MBSR+ and SMH were delivered weekly by group for 8 weeks, then biweekly for another 8 weeks. The primary clinical outcome was reduction in headache days from baseline to 20 weeks. Magnetic resonance imaging (MRI) outcomes included activity of left dorsolateral prefrontal cortex (DLPFC) and cognitive task network during cognitive challenge, resting state connectivity of right dorsal anterior insula to DLPFC and cognitive task network, and gray matter volume of DLPFC, dorsal anterior insula, and anterior midcingulate. Secondary outcomes were headache-related disability, pain severity, response to treatment, migraine days, and MRI whole-brain analyses. Reduction in headache days from baseline to 20 weeks was greater for MBSR+ (7.8 [95% CI, 6.9-8.8] to 4.6 [95% CI, 3.7-5.6]) than for SMH (7.7 [95% CI 6.7-8.7] to 6.0 [95% CI, 4.9-7.0]) (P = 0.04). Fifty-two percent of the MBSR+ group showed a response to treatment (50% reduction in headache days) compared with 23% in the SMH group (P = 0.004). Reduction in headache-related disability was greater for MBSR+ (59.6 [95% CI, 57.9-61.3] to 54.6 [95% CI, 52.9-56.4]) than SMH (59.6 [95% CI, 57.7-61.5] to 57.5 [95% CI, 55.5-59.4]) (P = 0.02). There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed. Enhanced mindfulness-based stress reduction is an effective treatment option for episodic migraine.",2020,"There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed.","['episodic migraine', '98 adults with episodic migraine recruited at a single academic center comparing MBSR+ (n=50) to SMH (n=48', 'headache (SMH']","['Enhanced mindfulness based stress reduction (MBSR', 'SMH', 'enhanced mindfulness based stress reduction (MBSR', 'MBSR+ and SMH', 'MBSR']","['headache days', 'headache-related disability', 'activity of left dorsolateral prefrontal cortex (DLPFC) and cognitive task network during cognitive challenge, resting state connectivity of right dorsal anterior insula (daINS) to DLPFC and cognitive task network, and gray matter volume of DLPFC, daINS, and anterior midcingulate', 'reduction in headache days', 'headache-related disability, pain severity, response to treatment, migraine days, and MRI whole-brain analyses']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula (body structure)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",98.0,0.12879,"There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Shana A B', 'Initials': 'SAB', 'LastName': 'Burrowes', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kearson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Luma', 'Initials': 'L', 'LastName': 'Samawi', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Furman', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Keaser', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Neda F', 'Initials': 'NF', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Magyari', 'Affiliation': 'Private Mindfulness-based Psychotherapy Practice, Baltimore, MD, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'White', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Goloubeva', 'Affiliation': 'University of Maryland Greenebaum Comprehensive Cancer Center, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Madhav', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'B Lee', 'Initials': 'BL', 'LastName': 'Peterlin', 'Affiliation': 'Neuroscience Institute, Penn Medicine Lancaster General Health, Lancaster, PA, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Haythornthwaite', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}]",Pain,['10.1097/j.pain.0000000000001860']
300,32176657,Individually Tailored Internet-Based Cognitive-Behavioral Therapy for Daily Functioning in Patients with Parkinson's Disease: A Randomized Controlled Trial.,"BACKGROUND


Parkinson's disease (PD) is often associated with psychological distress and lowered daily functioning. The availability of psychological interventions tailored for people with Parkinson is very limited.
OBJECTIVE


To study if guided individually-tailored internet-based cognitive behavioral therapy (ICBT) provide additional value to standard medical treatment for PD.
METHODS


Seventy-seven individuals with PD and self-reported problems with general function measured with the Work and Social Adjustment Scale (WSAS > 15) were randomized to 10 weeks of either ICBT combined with standard medical treatment, or standard medical treatment plus being on waitlist to ICBT (CONTROL). Change in the main outcome WSAS, as well as secondary measures such as quality of life, depression, anxiety and insomnia symptoms were investigated post treatment.
RESULTS


Participants receiving ICBT reported significantly higher functioning after treatment (WSAS group difference -4.56, controlled effect size g = 0.69, significant group by time interaction, Wχ2= 26.23, p = 0.001). However, only around one third of participants in the treatment group were classified as treatment responders, defined as having a 30% reduction on the WSAS post treatment. Patient involvement and ratings of ICBT credibility were high. Symptoms of anxiety, depression and insomnia symptoms were significantly lower after treatment compared to CONTROL. There were also positive effects on Parkinson-specific function and quality of life in the treatment group.
CONCLUSIONS


ICBT as an addition to standard medical treatment was credible and improved functioning for some individuals with PD. Still, the treatment needs further development in order to help a larger proportion of individuals with PD.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02627885.",2020,"Symptoms of anxiety, depression and insomnia symptoms were significantly lower after treatment compared to CONTROL.","['Seventy-seven individuals with PD and self-reported problems with general function measured with the Work and Social Adjustment Scale (WSAS', ""Parkinson's disease (PD"", ""Patients with Parkinson's Disease"", 'people with Parkinson']","['ICBT', 'ICBT combined with standard medical treatment, or standard medical treatment plus being on waitlist to ICBT', 'guided individually-tailored internet-based cognitive behavioral therapy (ICBT', 'Individually Tailored Internet-Based Cognitive-Behavioral Therapy']","['Symptoms of anxiety, depression and insomnia symptoms', 'Parkinson-specific function and quality of life', 'ICBT credibility', 'quality of life, depression, anxiety and insomnia symptoms']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}]",77.0,0.0858481,"Symptoms of anxiety, depression and insomnia symptoms were significantly lower after treatment compared to CONTROL.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kraepelien', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schibbye', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Månsson', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sundström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Riggare', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Lindefors', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Svenningsson', 'Affiliation': 'Department of Clinical Neuroscience, Section of Neurology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}]",Journal of Parkinson's disease,['10.3233/JPD-191894']
301,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
302,32203986,Cecal intubation time between the use of one-channel and two-channel water exchange colonoscopy: A randomized controlled trial.,"BACKGROUND AND AIM


Water exchange (WE) colonoscopy is the least painful insertion technique with high adenoma detection rate but requires a longer intubation time. In the published literature, some investigators used the instrument channel for both infusing and suctioning of water (one channel), while others use colonoscopes with an integrated water-jet channel specifically designed for infusing water (two channel). The aim of this study was to compare cecal intubation time between one-channel and two-channel WE.
METHODS


A total 120 patients undergoing colonoscopy from May 2017 to April 2019 at a regional hospital in southern Taiwan were randomized to either a two-channel group (n = 60) or a one-channel group (n = 60). The primary outcome was cecal intubation time.
RESULTS


The mean cecal intubation time was significantly shorter in the two-channel group compared with the one-channel group (14.0 ± 4.0 vs 17.4 ± 6.7 min, P < 0.001). The two-channel group required less water infused during insertion (564.8 ± 232.4 vs 1213.3 ± 467.5 mL, P < 0.001) but achieved a significantly higher Boston Bowel Preparation Scale score (8.4 ± 0.8 vs 7.5 ± 1.1, P < 0.001) than did the one-channel group. The adenoma detection rate was comparable in the two groups (50.0% vs 48.3%, P = 0.855).
CONCLUSIONS


In comparison with the one-channel WE, two-channel WE showed a shorter cecal intubation time, required less amount of water during insertion, and provided a better salvage cleansing effect. (NCT03279705).",2020,"The mean cecal intubation time was significantly shorter in the two-channel group compared with the one-channel group (14.0 ± 4.0 min vs. 17.4 ± 6.7 min, P < 0.001).",['A total 120 patients undergoing colonoscopy from May 2017 to April 2019 at a regional hospital in southern Taiwan'],"['One- and Two-Channel Water Exchange Colonoscopy', 'channel group (n=60) or a one-channel group']","['shorter cecal intubation time', 'Cecal Intubation Time', 'mean cecal intubation time', 'cecal intubation time', 'higher Boston Bowel Preparation Scale score', 'ADR']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}]",120.0,0.0829449,"The mean cecal intubation time was significantly shorter in the two-channel group compared with the one-channel group (14.0 ± 4.0 min vs. 17.4 ± 6.7 min, P < 0.001).","[{'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tseng', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Koo', 'Affiliation': 'Graduate Institute of Long-term Care, Tzu Chi University of Science and Technology, Hualien City, Hualien, Taiwan.'}, {'ForeName': 'Yu-Hsi', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15043']
303,31127779,Repetitive Transcranial Magnetic Stimulation Induced Hypoconnectivity Within the Default Mode Network Yields Cognitive Improvements in Amnestic Mild Cognitive Impairment: A Randomized Controlled Study.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) is thought to be effective in alleviating cognitive symptoms in patients with amnestic mild cognitive impairment (aMCI), but the mechanisms related to network modification are poorly understood.
OBJECTIVE


Here we tested rTMS efficacy and explored the effect of rTMS-induced changes in the default mode network (DMN) and their predictive value for treatment response.
METHODS


Twenty-one subjects clinically diagnosed with aMCI were recruited to complete a 10-session randomized and sham-controlled rTMS treatment targeting the right dorsolateral prefrontal cortex. Resting-state functional magnetic resonance imaging in tandem with neuropsychological assessments were administered before and after the intervention. Changes in functional connectivity of the DMN and relevant brain regions, as well as the correlations between baseline functional connectivity and clinical rating scales were calculated in order to elucidate the mechanism of treatment response to rTMS therapy.
RESULTS


Compared to the sham group, the rTMS group achieved improvement of neuropsychological performance and significant functional connectivity changes within the DMN. Group×Time interactions were found between posterior cingulate gyrus and right fusiform gyrus (F (1,19)  = 17.154, p = 0.001), and also left anterior cingulate gyrus (F (1,19)  = 3.908, p = 0.063), showing an rTMS-induced deactivation of functional connectivity within the DMN. Baseline functional connectivity analysis of seeds within the DMN in the rTMS group revealed negative correlation with AVLT-Recognition score changes.
CONCLUSION


rTMS-induced hypoconnectivity within DMN is associated with clinical cognitive improvements in patients with aMCI. Further, pre-rTMS baseline activity of the DMN at rest may be a predictor for favorable rTMS treatment response.",2019,"Compared to the sham group, the rTMS group achieved improvement of neuropsychological performance and significant functional connectivity changes within the DMN.","['patients with amnestic mild cognitive impairment (aMCI', 'patients with aMCI', 'Amnestic Mild Cognitive Impairment', 'Twenty-one subjects clinically diagnosed with aMCI']","['sham-controlled rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'Repetitive Transcranial Magnetic Stimulation Induced Hypoconnectivity']","['neuropsychological performance and significant functional connectivity changes', 'posterior cingulate gyrus and right fusiform gyrus', 'functional connectivity of the DMN and relevant brain regions', 'baseline functional connectivity and clinical rating scales']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0332493', 'cui_str': 'Fusiform shape (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}]",21.0,0.0558926,"Compared to the sham group, the rTMS group achieved improvement of neuropsychological performance and significant functional connectivity changes within the DMN.","[{'ForeName': 'Hailun', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Rujing', 'Initials': 'R', 'LastName': 'Ren', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guozhen', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhengde', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chunbo', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology & Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181296']
304,31178434,Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.,"OBJECTIVE


The Restoring Insulin Secretion (RISE) Adult Medication Study compared pharmacological approaches targeted to improve β-cell function in individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration.
RESEARCH DESIGN AND METHODS


A total of 267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied. Participants were randomized to receive 12 months of metformin alone, 3 months of insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin, 12 months of liraglutide combined with metformin, or 12 months of placebo. β-Cell function was assessed using hyperglycemic clamps at baseline, 12 months (on treatment), and 15 months (3 months off treatment). The primary outcome was β-cell function at 15 months compared with baseline.
RESULTS


All three active treatments produced on-treatment reductions in weight and improvements in HbA 1c  compared with placebo; the greatest reductions were seen in the liraglutide plus metformin group. At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group. Despite on-treatment benefits, 3 months after treatment withdrawal there were no sustained improvements in β-cell function in any treatment group.
CONCLUSIONS


In adults with IGT or recently diagnosed type 2 diabetes, interventions that improved β-cell function during active treatment failed to produce persistent benefits after treatment withdrawal. These observations suggest that continued intervention may be required to alter the progressive β-cell dysfunction in IGT or early type 2 diabetes.",2019,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","['Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes', 'individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration', '267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied']","['liraglutide combined with metformin', 'placebo', 'insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin', 'metformin', 'liraglutide plus metformin']","['Restoring Insulin Secretion (RISE', 'β-cell function', 'weight and improvements in HbA 1c', 'arginine-stimulated incremental C-peptide response', 'glucose-stimulated C-peptide responses', 'β-Cell function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",267.0,0.0446286,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0556']
305,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8']
306,31433058,A longitudinal analysis of albendazole treatment effect on neurocysticercosis cyst evolution using multistate models.,"BACKGROUND


In neurocysticercosis, the larval form of the pork tapeworm Taenia solium appears to evolve through three phases-active, degenerative and sometimes calcification-before disappearance. The antihelmintic drug, albendazole, has been shown to hasten the resolution of active cysts in neurocysticercosis. Little is known about the time cysts take to progress through each phase, with or without treatment.
METHODS


We reconfigured brain imaging data from patient level to cyst level for 117 patients in a randomized clinical trial of albendazole in which images were taken at baseline, 1, 6, 12 and 24 mo. Applying a multistate model, we modelled the hazard of a cyst evolving to subsequent cyst phases before the next imaging (vs no change). We examined the impact of albendazole treatment overall and by patient and cyst characteristics on the hazard.
RESULTS


Albendazole accelerated the evolution from the active to degenerative phase (HR=2.7, 95% CI 1.3 to 6.5) and from the degenerative phase to disappearance (HR=1.9, 95% CI 1.1 to 3.9). Albendazole's impact was stronger for patients who were male, did not have calcified cysts at baseline and who had multiple cysts in different locations.
CONCLUSIONS


This research provides a better understanding of where in the cyst trajectory albendazole has the greatest impact.",2019,"Albendazole's impact was stronger for patients who were male, did not have calcified cysts at baseline and who had multiple cysts in different locations.
",['patient level to cyst level for 117 patients'],"['Albendazole', 'albendazole']",['neurocysticercosis cyst evolution'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0338437', 'cui_str': 'Cysticercosis, Brain'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]",117.0,0.124218,"Albendazole's impact was stronger for patients who were male, did not have calcified cysts at baseline and who had multiple cysts in different locations.
","[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Montgomery', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kelvin', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Carpio', 'Affiliation': 'School of Medicine, University of Cuenca, Av 12 de Abril s/n Ciudadela Universitaria, 010201 Cuenca, Ecuador.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jaramillo', 'Affiliation': 'Instituto de Diagnóstico por Imágenes, Inés Salcedo 1-99, Cuenca, Ecuador.'}, {'ForeName': 'W Allen', 'Initials': 'WA', 'LastName': 'Hauser', 'Affiliation': 'Gertrude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, 630 168th Street, Columbia University, New York, New York 10032, USA.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/trz073']
307,32088543,Per- and polyfluoroalkyl substances and blood pressure in pre-diabetic adults-cross-sectional and longitudinal analyses of the diabetes prevention program outcomes study.,"The relationship of plasma concentration of per- and polyfluoroalkyl substances (PFAS) with blood pressure (BP) is uncertain. This study examined cross-sectional and prospective associations of PFAS with BP and hypertension. We quantified plasma PFAS concentrations from 957 participants enrolled in the lifestyle and placebo arms of the Diabetes Prevention Program (DPP), a randomized controlled trial with approximately 15 years of follow-up. We used multivariable linear and logistic regressions to test cross-sectional associations of six PFAS, including perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS), N-ethyl-perfluorooctane sulfonamido acetic acid (EtFOSAA), N-methyl-perfluorooctane sulfonamido acetic acid (MeFOSAA), and perfluorononanoic acid (PFNA), with BP and hypertension prevalence, respectively, at baseline. We used generalized linear mixed models to estimate longitudinal associations between baseline PFAS and the rate of BP changes, and Cox-Proportional hazard models to estimate risk of developing hypertension relative to baseline PFAS. Models were adjusted for baseline age, sex, race/ethnicity, treatment arm, educational attainment, income, marital status, smoking habit, alcohol drinking, and diet. We tested for effect modification by the treatment arm and sex, and accounted for multiple comparisons using the False-Discovery Rate (FDR). PFAS concentrations and hypertension prevalence within the study population (65.3% female, 57.7% White, 65.3% aged 40-59 years) were comparable to the general U.S. population. Cross-sectionally, we found small but statistically significant associations of baseline plasma concentrations of PFOA with systolic BP (β per doubling: 1.49 mmHg, 95% CI: 0.29, 2.70); and MeFOSAA with hypertension (RR = 1.09 per doubling, 95% CI: 1.01, 1.19). Estimates were not statistically significant after FDR adjustment. Longitudinally, we observed null associations in the placebo arm, but some inverse associations of baseline PFOS and MeFOSAA with systolic BP in the lifestyle arm, perhaps due to regression toward the mean. Baseline PFAS concentrations also were not prospectively associated with hypertension risk. Overall, there were modest and mostly null associations of plasma PFAS concentrations with BP and hypertension.",2020,Baseline PFAS concentrations also were not prospectively associated with hypertension risk.,"['957 participants enrolled in the lifestyle and placebo arms of the Diabetes Prevention Program (DPP), a randomized controlled trial with approximately 15\xa0years of follow-up', 'within the study population (65.3% female, 57.7% White, 65.3% aged 40-59\xa0years']","['placebo', 'Per- and polyfluoroalkyl substances and blood pressure']","['plasma concentration of per- and polyfluoroalkyl substances (PFAS) with blood pressure (BP', 'perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS), N-ethyl-perfluorooctane sulfonamido acetic acid (EtFOSAA), N-methyl-perfluorooctane sulfonamido acetic acid (MeFOSAA), and perfluorononanoic acid (PFNA), with BP and hypertension prevalence', 'plasma PFAS concentrations with BP and hypertension', 'Baseline PFAS concentrations', 'baseline PFOS and MeFOSAA with systolic BP', 'False-Discovery Rate (FDR', 'PFAS concentrations and hypertension prevalence', 'baseline plasma concentrations of PFOA with systolic BP (β per doubling']","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctanesulfonic acid'}, {'cui': 'C0070403', 'cui_str': 'perfluorooctanoic acid'}, {'cui': 'C1176320', 'cui_str': 'perflexane'}, {'cui': 'C0038762', 'cui_str': 'Sulfonic Acids'}, {'cui': 'C0166273', 'cui_str': 'perfluorooctane'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C3712911', 'cui_str': 'Nonanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluoro-'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",957.0,0.0700998,Baseline PFAS concentrations also were not prospectively associated with hypertension risk.,"[{'ForeName': 'Pi-I D', 'Initials': 'PD', 'LastName': 'Lin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: p_lin@harvardpilgrim.org.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, CA, USA. Electronic address: andres.cardenas@berkeley.edu.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Hauser', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: rhauser@hsph.harvard.edu.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: redrg@channing.harvard.edu.""}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Kleinman', 'Affiliation': 'Department of Biostatistics, School of Public Health and Human Sciences, University of Massachusetts Amherst, Amherst, MA, USA.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA; Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: mhivert@partners.org.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: aic7@cdc.gov.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Webster', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA, USA. Electronic address: twebster@bu.edu.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA. Electronic address: edward.horton@joslin.harvard.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: emily_oken@harvardpilgrim.org.'}]",Environment international,['10.1016/j.envint.2020.105573']
308,31368793,Facilitators and barriers to successful recruitment into a large comparative effectiveness trial: a qualitative study.,"Background:  Recruitment of participants into research studies, especially individuals from minority groups, is challenging; lack of diversity may lead to biased findings.  Aim:  To explore beliefs about research participation among individuals who were approached and eligible for the GRADE study.  Methods:  In-depth qualitative telephone interviews with randomized participants (n = 25) and eligible individuals who declined to enroll (n = 26).  Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation. Few participants understood how comparative effectiveness research differed from other types of trials; however, some features of comparative effectiveness research were perceived as lower risk.  Conclusion:  We identified facilitators and addressable barriers to participation in research studies.",2019,"Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","['randomized participants (n\xa0=\xa025) and eligible individuals who declined to enroll (n\xa0=\xa026', 'participants into research studies, especially individuals from minority groups', 'individuals who were approached and eligible for the GRADE study']",[],"['trust and perceptions of risk, benefits and burden of participation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035168'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",[],"[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.150427,"Results:  Refusers and consenters differed in trust and perceptions of risk, benefits and burden of participation.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Behringer-Massera', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Diabetes and Bone Diseases, Icahn School of Medicine, 1 Gustave L Levy Place, NY 10029, USA.'}, {'ForeName': 'Terysia', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Geny', 'Initials': 'G', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Duran', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL 35294, USA.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of comparative effectiveness research,['10.2217/cer-2019-0010']
309,32251253,No Sex Difference in Mental Fatigue Effect on High-Level Runners' Aerobic Performance.,"PURPOSE


Some evidence suggests that sedentary women may be more vulnerable to cognitive task-induced mental fatigue. Mental fatigue, in turn, may worse aerobic exercise performance, presumably via increased perceived effort. However, it remains unclear whether acute mental fatigue induction increases perceived effort and worsens endurance performance in high-level professional athletes and whether such effects are influenced by sex.
METHODS


We studied 30 athletes (15 women and 16 men) in a single-blinded, randomized, controlled and crossover protocol. In separate visits, athletes either performed a 45-min cognitive task (Stroop's color-word conflict test) to induce mental fatigue or watched a 45-min documentary as control. Then athletes performed a time-to-exhaustion test on a treadmill.
RESULTS


Perceptual measures and cognitive performance indicated that the prolonged cognitive task induced a similar mental fatigue state in women and men. Cardiorespiratory and metabolic responses to the TEE did not change with mental fatigue in both sexes. Mental fatigue increased perceived effort during the time-to-exhaustion test, anticipated attainment of maximal effort, and shortened time to exhaustion similarly in women and men (mean ± SE, -27.3 ± 20.9 s for women vs -26.7 ± 15.1 s for men; P = 0.98).
CONCLUSIONS


The prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort, and worsened aerobic performance in professional runners with no sex differences. Although we did not contrasted athletes with nonathletes, our results suggest that being an athlete may somehow prevent women from developing greater mental fatigue and suffering more from its underlying effects compared with men.",2020,"The prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort and worsened aerobic performance in professional runners with no sex differences.","['sedentary women', 'professional runners with no sex differences', 'thirty athletes (15 women and 16 men', 'high-level professional athletes']","['TEE', ""45-min cognitive task (Stroop's color-word conflict test) to induce mental fatigue or watched a 45-min documentary as control""]","['mental fatigue state', ""Mental Fatigue Effect on High-Level Runners' Aerobic Performance"", 'cognitive task-induced mental fatigue', 'Mental fatigue', 'prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort and worsened aerobic performance', 'Cardiorespiratory and metabolic responses', 'mental fatigue']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341632', 'cui_str': 'Professional runner'}, {'cui': 'C0036866', 'cui_str': 'Sex Differences'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",30.0,0.127486,"The prolonged cognitive task provoked mental fatigue, anticipated attainment of maximal perceived effort and worsened aerobic performance in professional runners with no sex differences.","[{'ForeName': 'Thiago Ribeiro', 'Initials': 'TR', 'LastName': 'Lopes', 'Affiliation': 'Graduate Program in Translational Medicine, Federal University of São Paulo, SP, BRAZIL.'}, {'ForeName': 'Diogo Machado', 'Initials': 'DM', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Translational Medicine, Federal University of São Paulo, SP, BRAZIL.'}, {'ForeName': 'Paula BrandÃo', 'Initials': 'PB', 'LastName': 'Simurro', 'Affiliation': 'Interdisciplinary Laboratory of Clinical Neurosciences, Department of Psychiatry, Federal University of São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Henrique Teruo', 'Initials': 'HT', 'LastName': 'Akiba', 'Affiliation': 'Interdisciplinary Laboratory of Clinical Neurosciences, Department of Psychiatry, Federal University of São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'FÁbio Yuzo', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Graduate Program in Physical Education UPE/UFPB, João Pessoa, PB, BRAZIL.'}, {'ForeName': 'Alexandre Hideki', 'Initials': 'AH', 'LastName': 'Okano', 'Affiliation': 'Graduate Program in Physical Education, State University of Londrina, Londrina, PR, BRAZIL.'}, {'ForeName': 'Álvaro Machado', 'Initials': 'ÁM', 'LastName': 'Dias', 'Affiliation': 'Interdisciplinary Laboratory of Clinical Neurosciences, Department of Psychiatry, Federal University of São Paulo, São Paulo, SP, BRAZIL.'}, {'ForeName': 'Bruno Moreira', 'Initials': 'BM', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Translational Medicine, Federal University of São Paulo, SP, BRAZIL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002346']
310,32251254,Using TENS to Enhance Therapeutic Exercise in Individuals with Knee Osteoarthritis.,"Transcutaneous electrical nerve stimulation (TENS) facilitates quadriceps voluntary activation in experimental settings. Augmenting therapeutic exercise (TE) with TENS may enhance the benefits of TE in individuals with knee osteoarthritis (KOA) and quadriceps voluntary activation failure (QVAF).
PURPOSE


This study aimed to determine the effect of TENS + TE on patient-reported function, quadriceps strength, and voluntary activation, as well as physical performance compared with sham TENS + TE (Sham) and TE alone in individuals with symptomatic KOA and QVAF.
METHODS


Ninety individuals participated in a double-blinded randomized controlled trial. Everyone received 10 standardized TE sessions of physical therapy. TENS + TE and Sham groups applied the respective devices during all TE sessions and throughout activities of daily living over 4 wk. The Western Ontario and McMaster University Osteoarthritis Index (WOMAC), quadriceps strength, and voluntary activation, as well as a 20-m walk test, chair-stand test, and stair-climb test were performed at baseline, after the 4-wk intervention (post 1) and at 8 wk after the start of the intervention (post 2). Mixed-effects models were used to determine between-group differences between baseline and post 1, as well as baseline and post 2.
RESULTS


Improvements in WOMAC subscales, quadriceps strength, and voluntary activation, 20-m walk times, chair-stand repetitions, and stair-climb time were found at post 1 and post 2 compared with baseline for all groups (P < 0.05). WOMAC Pain and Stiffness improved in the TENS + TE group compared with TE alone at post 1 (P < 0.05); yet, no other between-group differences were found.
CONCLUSIONS


TE effectively improved patient-reported function, quadriceps strength, and voluntary activation, as well as physical performance in individuals with symptomatic KOA and QVAF, but augmenting TE with TENS did not improve the benefits of TE.",2020,"WOMAC Pain and Stiffness improved in the TENS+TE group compared to TE alone at Post 1 (p<0.05); yet no other between-group differences were found.
","['Ninety individuals participated', 'individuals with symptomatic KOA and QVAF', 'individuals with knee osteoarthritis (KOA) and quadriceps voluntary activation failure (QVAF', 'Individuals with Knee Osteoarthritis']","['TENS+TE', 'therapeutic exercise (TE) with TENS', 'Transcutaneous electrical nerve stimulation (TENS', 'TENS', 'sham TENS+TE (Sham), and TE alone', 'Everyone received 10 standardized TE sessions of physical therapy']","['Western Ontario and McMaster University Osteoarthritis Index [WOMAC], quadriceps strength and voluntary activation', 'WOMAC Pain and Stiffness', 'TE effectively improved patient-reported function, quadriceps strength and voluntary activation', 'WOMAC subscales, quadriceps strength and voluntary activation, 20-meter walk times, chair-stand repetitions, and stair-climb time']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0224440', 'cui_str': 'Structure of quadriceps femoris muscle'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}]",90.0,0.054057,"WOMAC Pain and Stiffness improved in the TENS+TE group compared to TE alone at Post 1 (p<0.05); yet no other between-group differences were found.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Luc-Harkey', 'Affiliation': 'Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Harkey', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Hope C', 'Initials': 'HC', 'LastName': 'Davis-Wilson', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Pfeiffer', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nissman', 'Affiliation': 'Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'MOTION Science Institute, Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Jeffery T', 'Initials': 'JT', 'LastName': 'Spang', 'Affiliation': 'Department of Orthopaedics, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002353']
311,31261373,Placental pathology and neonatal brain MRI in a randomized trial of erythropoietin for hypoxic-ischemic encephalopathy.,"BACKGROUND


Newborns with hypoxic-ischemic encephalopathy (HIE) may exhibit abnormalities on placental histology. In this phase II clinical trial ancillary study, we hypothesized that placental abnormalities correlate with MRI brain injury and with response to treatment.
METHODS


Fifty newborns with moderate/severe encephalopathy who received hypothermia were enrolled in a double-blind, placebo-controlled trial of erythropoietin for HIE. A study pathologist reviewed all available clinical pathology reports to determine the presence of chronic abnormalities and acute chorioamnionitis. Neonatal brain MRIs were scored using a validated HIE scoring system.
RESULTS


Placental abnormalities in 19 of the 35 (54%) patients with available pathology reports included chronic changes (N = 13), acute chorioamnionitis (N = 9), or both (N = 3). MRI subcortical brain injury was less common in infants with a placental abnormality (26 vs. 69%, P = 0.02). Erythropoietin treatment was associated with a lower global brain injury score (median 2.0 vs. 11.5, P = 0.003) and lower rate of subcortical brain injury (33 vs. 90%, P = 0.01) among patients with no chronic placental abnormality but not in patients whose placentas harbored a chronic abnormality.
CONCLUSION


Erythropoietin treatment was associated with less brain injury only in patients whose placentas exhibited no chronic histologic changes. Placentas may provide clues to treatment response in HIE.",2020,"Erythropoietin treatment was associated with a lower global brain injury score (median 2.0 vs. 11.5, P = 0.003) and lower rate of subcortical brain injury (33 vs. 90%, P = 0.01) among patients with no chronic placental abnormality but not in patients whose placentas harbored a chronic abnormality.
","['Placental abnormalities in 19 of the 35 (54%) patients with available pathology reports included', 'Newborns with hypoxic-ischemic encephalopathy (HIE', 'hypoxic-ischemic encephalopathy', 'Fifty newborns with moderate/severe encephalopathy who received hypothermia']","['erythropoietin for HIE', 'Erythropoietin', 'placebo', 'erythropoietin']","['chronic histologic changes', 'Neonatal brain MRIs', 'chronic changes', 'global brain injury score', 'MRI subcortical brain injury', 'rate of subcortical brain injury']","[{'cui': 'C1306893', 'cui_str': 'Placental abnormality (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0807321', 'cui_str': 'Pathology report (record artifact)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathies'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",50.0,0.122361,"Erythropoietin treatment was associated with a lower global brain injury score (median 2.0 vs. 11.5, P = 0.003) and lower rate of subcortical brain injury (33 vs. 90%, P = 0.01) among patients with no chronic placental abnormality but not in patients whose placentas harbored a chronic abnormality.
","[{'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA. WuY@ucsf.edu.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Goodman', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Department of Neurology, Children's National Health Systems, Washington, DC, USA.""}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ""Department of Neurology, Children's National Health Systems, Washington, DC, USA.""}, {'ForeName': 'Fernando F', 'Initials': 'FF', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Mathur', 'Affiliation': 'Departments of Pediatrics, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Krisa', 'Initials': 'K', 'LastName': 'Van Meurs', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'McKinstry', 'Affiliation': 'Department of Radiology, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Redline', 'Affiliation': 'Department of Pathology, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Pediatric research,['10.1038/s41390-019-0493-6']
312,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
313,32248355,Circumferential Heller myotomy can relieve chest pain in patients with achalasia: a prospective clinical trial.,"BACKGROUND


Noncardiac chest pain often coexists with dysphagia in patients diagnosed with achalasia. The current standard treatment for achalasia, laparoscopic Heller myotomy with Dor fundoplication, has an insufficient effect on noncardiac chest pain. The aim of this study is to investigate the efficacy of circumferential Heller myotomy on esophageal chest pain in patients with achalasia.
METHODS


Twenty patients diagnosed with achalasia who complained of noncardiac chest pain were recruited and underwent circumferential Heller myotomy. Using an institutional achalasia database, we randomly selected 60 patients who underwent standard laparoscopic Heller myotomy with Dor fundoplication, based on a 3-to-1 propensity score-matching analysis. We compared surgical outcomes between the circumferential Heller myotomy and the laparoscopic Heller myotomy with Dor fundoplication groups.
RESULTS


Patients undergoing circumferential Heller myotomy had a higher rate of postoperative noncardiac chest pain relief than the laparoscopic Heller myotomy with Dor fundoplication group [95% (19/20) vs. 75% (45/60), p = 0.045]. No differences in dysphagia and vomiting were found between groups (p = 0.783 and p = 0.645, respectively). Patients in the circumferential Heller myotomy group had significantly better esophageal clearance. The prevalence of reflux endoscopic esophagitis was higher in the circumferential Heller myotomy group than in the control group [35.0% (7/20) vs. 10.0% (6/60), p = 0.015].
CONCLUSIONS


There is promising early evidence that circumferential Heller myotomy may be effective in the treatment of achalasia-related chest pain. Further research, including larger randomized studies with long-term follow-up, is warranted.",2020,"The prevalence of reflux endoscopic esophagitis was higher in the circumferential Heller myotomy group than in the control group [35.0% (7/20) vs. 10.0% (6/60), p = 0.015].
","['patients diagnosed with achalasia', 'Twenty patients diagnosed with achalasia who complained of noncardiac chest pain were recruited and underwent circumferential Heller myotomy', '60 patients who underwent', 'patients with achalasia']","['Circumferential Heller myotomy', 'circumferential Heller myotomy', 'standard laparoscopic Heller myotomy with Dor fundoplication']","['rate of postoperative noncardiac chest pain relief', 'esophageal chest pain', 'prevalence of reflux endoscopic esophagitis', 'esophageal clearance', 'dysphagia and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C4505237', 'cui_str': ""Heller's Myotomy""}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C4505237', 'cui_str': ""Heller's Myotomy""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4505238', 'cui_str': 'Laparoscopic Heller Cardiomyotomy'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0232533', 'cui_str': 'Esophageal chest pain'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",60.0,0.0654229,"The prevalence of reflux endoscopic esophagitis was higher in the circumferential Heller myotomy group than in the control group [35.0% (7/20) vs. 10.0% (6/60), p = 0.015].
","[{'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Yano', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan. f-yano@jikei.ac.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Omura', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Se Ryung', 'Initials': 'SR', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Akimoto', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Yanaga', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}]",Esophagus : official journal of the Japan Esophageal Society,['10.1007/s10388-020-00738-5']
314,31929122,EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson's Disease.,"BACKGROUND


Gocovri® (amantadine) extended release capsules are approved for the treatment of dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy.
OBJECTIVE


To evaluate the long-term safety, tolerability, and efficacy of Gocovri in patients with PD experiencing levodopa-induced dyskinesia.
METHODS


In this 2-year open-label trial, patients completing double-blind Gocovri clinical trials or excluded from prior trials because of deep-brain stimulation (DBS) received Gocovri 274 mg once daily at bedtime. The primary objective was to evaluate long-term safety and tolerability. In addition, dyskinesia and OFF time were assessed using Part IV (Motor Complications) scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
RESULTS


Among 223 enrolled patients (mean PD duration, 11.7 years; mean levodopa use, 9.3 years), 75.8% completed 1 year of treatment and 57.8% completed the trial, with a median treatment duration of 1.9 years. Common adverse events were fall (32.7%), hallucination (24.2%), peripheral edema (16.1%), constipation (13.5%), and urinary tract infection (10.3%); 31 patients (13.9%) discontinued because of adverse events considered related to study drug. At baseline, MDS-UPDRS Part IV scores were lower for patients continuing Gocovri (mean, 6.5 points) than for previous placebo (9.4) or DBS groups (10.5) but were similar for all groups by week 8 (6.3, 6.2, 6.4, respectively), and remained low for the duration of the trial (at week 100: 6.9, 7.3, 7.0, respectively).
CONCLUSIONS


In patients with PD, Gocovri showed long-term safety and tolerability consistent with double-blind trial findings, and durable reduction in motor complications (dyskinesia and OFF time).",2020,"Common adverse events were fall (32.7%), hallucination (24.2%), peripheral edema (16.1%), constipation (13.5%), and urinary tract infection (10.3%); 31 patients (13.9%) discontinued study drug because of adverse events considered related to study drug.","[""patients with Parkinson's disease (PD) receiving levodopa-based therapy"", 'patients with PD experiencing levodopa-induced dyskinesia', '223 enrolled patients (mean PD duration, 11.7 years; mean levodopa use, 9.3 years), 75.8% completed 1 year of treatment and 57.8% completed the trial, with a median treatment duration of 1.9 years']","['Gocovri® (amantadine', 'Gocovri (Amantadine', 'placebo', 'Gocovri 274\u200amg once daily at bedtime']","['dyskinesia and OFF time', 'MDS-UPDRS Part IV scores', 'constipation', 'peripheral edema', 'long-term safety and tolerability', 'motor complications (dyskinesia and OFF time', ""Part IV (Motor Complications) scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'urinary tract infection', 'evaluate long-term safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}]","[{'cui': 'C4522700', 'cui_str': 'Gocovri'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}]","[{'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",223.0,0.172543,"Common adverse events were fall (32.7%), hallucination (24.2%), peripheral edema (16.1%), constipation (13.5%), and urinary tract infection (10.3%); 31 patients (13.9%) discontinued study drug because of adverse events considered related to study drug.","[{'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Tanner', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Oertel', 'Affiliation': 'Philipps University, Marburg, Germany.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jankovic', 'Affiliation': ""Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston TX, USA.""}, {'ForeName': 'Reed', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Chernick', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hubble', 'Affiliation': 'Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-191841']
315,32250190,"Pupil Diameter, Corneal Thickness, and Anterior Chamber Alterations Following Topical Olopatadine Hydrochloride 0.1%: A Single-Masked Randomized Controlled Clinical Study.","Purpose:  Olopatadine hydrochloride 0.1% is one of the known primary topical treatments in ocular allergy. Although olopatadine is a worldwide used medication, the changes in pupil diameter, cornea, and anterior chamber associated with its use have not been studied in detail. In this prospective study, we aimed to determine the amount of mydriasis and explore the possible corneal and anterior chamber alterations after 0.1% topical olopatadine.  Methods:  A total of 77 eyes from 77 ocular-allergy diagnosed patients between 18 and 40 years were investigated in this prospective study. Thirty-nine eyes of 39 patients received topical olopatadine, and 38 eyes of 38 patients received sterile distilled water, randomly. Pentacam (Oculus Optikgeräte GmbH, Wetzlar, Germany) topography was used to assess the pupil and anterior chamber measurements at baseline and after 45 min of olopatadine or sterile distilled water instillation.  Results:  The differences between the baseline and 45th-min measurements for corneal thickness, anterior chamber depth, angle, and volume did not reach a statistical significance in the olopatadine or control groups. The pupil diameter significantly increased from 3.19 ± 0.62 to 3.36 ± 0.62 mm in the olopatadine group ( P  < 0.001), and remained relatively unchanged in the control group ( P  = 0.06).  Conclusion:  Olopatadine 0.1% does not lead to a significant change in corneal topography or anterior chamber parameters. However, it causes a slight but statistically significant increase in pupil diameter.",2020,"The pupil diameter significantly increased from 3.19 ± 0.62 to 3.36 ± 0.62 mm in the olopatadine group ( P  < 0.001), and remained relatively unchanged in the control group ( P  = 0.06).  ","['ocular allergy', 'Thirty-nine eyes of 39 patients received', ' and 38 eyes of 38 patients received', 'A total of 77 eyes from 77 ocular-allergy diagnosed patients between 18 and 40 years']","['olopatadine or sterile distilled water instillation', 'olopatadine', 'Olopatadine', 'Olopatadine Hydrochloride', 'Olopatadine hydrochloride', 'topical olopatadine', 'sterile distilled water, randomly']","['corneal thickness, anterior chamber depth, angle, and volume', 'corneal topography or anterior chamber parameters', 'Pentacam (Oculus Optikgeräte GmbH, Wetzlar, Germany', 'pupil diameter', 'Pupil Diameter, Corneal Thickness, and Anterior Chamber Alterations']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0527189', 'cui_str': 'olopatadine'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0771892', 'cui_str': 'Olopatadine hydrochloride'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",77.0,0.0289475,"The pupil diameter significantly increased from 3.19 ± 0.62 to 3.36 ± 0.62 mm in the olopatadine group ( P  < 0.001), and remained relatively unchanged in the control group ( P  = 0.06).  ","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Çavdarli', 'Affiliation': 'Department of Ophthalmology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Topcu Yilmaz', 'Affiliation': 'Department of Ophthalmology, Ankara City Hospital, Ankara, Turkey.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2020.0007']
316,32172682,Can a computer detect interpersonal skills? Using machine learning to scale up the Facilitative Interpersonal Skills task.,"ABSTRACT Objective:  Therapist interpersonal skills are foundational to psychotherapy. However, assessment is labor intensive and infrequent. This study evaluated if machine learning (ML) tools can automatically assess therapist interpersonal skills. Method:  Data were drawn from a previous study in which 164 undergraduate students (i.e., not clinical trainees) completed the Facilitative Interpersonal Skills (FIS) task. This task involves responding to video vignettes depicting interpersonally challenging moments in psychotherapy. Trained raters scored the responses. We used an elastic net model on top of a term frequency-inverse document frequency representation to predict FIS scores. Results:  Models predicted FIS total and item-level scores above chance ( rho s = .27-.53,  p s < .001), achieving 31-60% of human reliability. Models explained 13-24% of the variance in FIS total and item-level scores on a held out set of data ( R 2 ), with the exception of the two items most reliant on vocal cues (verbal fluency, emotional expression), for which models explained ≤1% of variance. Conclusion:  ML may be a promising approach for automating assessment of constructs like interpersonal skill previously coded by humans. ML may perform best when the standardized stimuli limit the ""space"" of potential responses (vs. naturalistic psychotherapy) and when models have access to the same data available to raters (i.e., transcripts).",2020,"Results:  Models predicted FIS total and item-level scores above chance ( rho s = .27-.53,  p s < .001), achieving 31-60% of human reliability.","['164 undergraduate students (i.e., not clinical trainees']",['machine learning (ML'],"['Facilitative Interpersonal Skills (FIS) task', 'FIS total and item-level scores above chance', 'vocal cues (verbal fluency, emotional expression', 'FIS total and item-level scores']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",164.0,0.0363065,"Results:  Models predicted FIS total and item-level scores above chance ( rho s = .27-.53,  p s < .001), achieving 31-60% of human reliability.","[{'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Department of Counseling Psychology and Center for Healthy Minds, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tanana', 'Affiliation': 'College of Social Work, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Zac E', 'Initials': 'ZE', 'LastName': 'Imel', 'Affiliation': 'Department of Educational Psychology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Atkins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'Hill', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1741047']
317,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z']
318,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y']
319,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3']
320,30951586,Outcomes From a Sequential Multiple Assignment Randomized Trial of Weight Loss Strategies for African American Adolescents With Obesity.,"BACKGROUND


Minority adolescents are at highest risk for obesity and extreme obesity; yet, there are few clinical trials targeting African American adolescents with obesity.
PURPOSE


The purpose of the study was to develop an adaptive family-based behavioral obesity treatment for African American adolescents using a sequential multiple assignment randomized trial (SMART) design.
METHODS


Fit Families was a SMART where 181 African American adolescents (67% female) aged 12-17 were first randomized to office-based versus home-based behavioral skills treatment delivered from a Motivational Interviewing foundation. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based behavioral skills treatment or contingency management with voucher-based reinforcement for adolescent weight loss and for caregiver adherence to the program. All interventions were delivered by community health workers. The primary outcome was treatment retention and percent overweight.
RESULTS


All adolescents reduced percent overweight by -3.20%; there were no significant differences in percent overweight based on treatment sequence. Adolescents receiving home-based delivery in Phase 1 and contingency management in Phase 2 completed significantly more sessions than those receiving office-based treatment and continued skills without CM (M = 8.03, SD = 3.24 and M = 6.62, SD = 2.95, respectively). The effect of contingency management was strongest among older and those with lower baseline confidence. Younger adolescents experienced greater weight reductions when receiving continued skills (-4.90% compared with -.02%).
CONCLUSIONS


Behavioral skills training can be successfully delivered to African American adolescents with obesity and their caregivers by community health workers when using a home-based service model with incentives. More potent interventions are needed to increase reductions in percent overweight and may need to be developmentally tailored for younger and older adolescents.",2019,"Younger adolescents experienced greater weight reductions when receiving continued skills (-4.90% compared with -.02%).
","['African American adolescents with obesity', 'younger and older adolescents', 'Minority adolescents', '181 African American adolescents (67% female) aged 12-17', 'African American adolescents with obesity and their caregivers by community health workers', 'Younger adolescents', 'African American adolescents', 'African American Adolescents With Obesity']","['rerandomized to continued home-based behavioral skills treatment or contingency management with voucher-based reinforcement', 'office-based versus home-based behavioral skills treatment delivered from a Motivational Interviewing foundation', 'adaptive family-based behavioral obesity treatment', 'Behavioral skills training', 'Weight Loss Strategies']","['treatment retention and percent overweight', 'weight reductions']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0543326,"Younger adolescents experienced greater weight reductions when receiving continued skills (-4.90% compared with -.02%).
","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Naar', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, Florida State University, Tallahassee, FL.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ellis', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, MI.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Idalski Carcone', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, MI.'}, {'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Jacques-Tiura', 'Affiliation': 'Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, MI.'}, {'ForeName': 'Phillippe', 'Initials': 'P', 'LastName': 'Cunningham', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Templin', 'Affiliation': 'School of Nursing, Wayne State University, Detroit, MI.'}, {'ForeName': 'Kathryn Brogan', 'Initials': 'KB', 'LastName': 'Hartlieb', 'Affiliation': 'Stempel College of Public Health and Social Work, Florida International University, Miami, FL.'}, {'ForeName': 'K-L Cathy', 'Initials': 'KC', 'LastName': 'Jen', 'Affiliation': 'Department of Nutrition and Food Science, Wayne State University, Detroit, MI.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz003']
321,32246762,Effect of adjunctive vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of adjunctive use of vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy.
METHODS


A randomized controlled trial at Woman's Health Hospital, Assiut University, Egypt, between April 2017 and March 2019 enrolled women eligible for McDonald cerclage. After cerclage, participants were randomly assigned to receive progesterone (400 mg pessary) once daily until 37 weeks or no progesterone. The primary outcome was rate of abortion before 28 weeks. Secondary outcomes included gestational age at delivery, preterm delivery, mean birthweight, Apgar score, and admission to the neonatal intensive care unit (NICU).
RESULTS


The rate of spontaneous abortion was higher in the no-progesterone group (P=0.016). Mean gestational age and mean birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively). The frequency of preterm neonates, neonates with Apgar score less than 7, and admission to NICU was higher in the progesterone group than in the no-progesterone group (P=0.005, P=0.008, and P=0.044, respectively).
CONCLUSION


Adjunctive use of vaginal progesterone after McDonald cerclage was found to decrease the frequency of second-trimester abortion and to improve perinatal outcomes in singleton pregnancy. Clinicaltrials.gov: NCT02846909.",2020,"birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively).","['Mean gestational age and mean', 'singleton pregnancy', ""Woman's Health Hospital, Assiut University, Egypt, between April 2017 and March 2019 enrolled women eligible for McDonald cerclage""]","['adjunctive vaginal progesterone', 'progesterone (400\xa0mg pessary) once daily until 37\xa0weeks or no progesterone', 'vaginal progesterone']","['frequency of preterm neonates, neonates with Apgar score', 'rate of abortion', 'admission to NICU', 'gestational age at delivery, preterm delivery, mean birthweight, Apgar score, and admission to the neonatal intensive care unit (NICU', 'rate of second-trimester abortion', 'rate of spontaneous abortion', 'perinatal outcomes', 'frequency of second-trimester abortion', 'birthweight']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0032980', 'cui_str': 'Second trimester pregnancy'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}]",,0.209308,"birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively).","[{'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Sameh E', 'Initials': 'SE', 'LastName': 'Ahmed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Gamal H', 'Initials': 'GH', 'LastName': 'Sayed', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Esraa Y', 'Initials': 'EY', 'LastName': 'Badran', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abbas', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13148']
322,29514317,Reinforcement Enhancing Effects of Nicotine Via Patch and Nasal Spray.,"INTRODUCTION


Confirming preclinical findings, nicotine in humans (via smoking) enhances reinforcement from nondrug rewards. Recent demonstration of similar effects with nicotine via e-cigarettes suggests they may also occur when using nicotine replacement therapies (NRT).
METHODS


Effects of nicotine via NRT patch or nasal spray were assessed on responding reinforced by music, video, or monetary rewards, or for no reward (control). Nontreatment seeking smokers (N = 31) participated in three virtually identical experimental sessions, each following overnight abstinence (CO ≤ 10 ppm). In a fully within-subjects design using a double-dummy procedure, these sessions involved: (1) nicotine patch (Nicoderm 14 mg) plus placebo spray, (2) placebo patch plus nicotine spray (Nicotrol, 2 × 1 mg/trial), or (3) placebo patch plus placebo spray. Session order was counter-balanced.
RESULTS


Relative to placebo, reinforced responding due to nicotine via spray or patch was greater for video reward (both p < .01) but not for music reward (both p > .10). Similar results for NRT spray and patch confirms preclinical findings indicating no difference between fast and slow nicotine delivery, respectively, on reinforcement enhancing effects. Withdrawal relief was unrelated to these effects of nicotine via NRT on nondrug reinforcement.
CONCLUSIONS


Nicotine from NRT has some reinforcement enhancing effects in humans, possibly in a manner consistent with nicotine via e-cigarettes but not tobacco smoking. Our findings could suggest differential dose-dependency of available rewards to enhanced reinforcement by nicotine. Such effects may help contribute to the efficacy of NRT for aiding smoking cessation, but more research focusing on dose-dependency of these nicotine actions is needed.
IMPLICATIONS


Acute nicotine from smoking enhances reinforced responding for nondrug sensory rewards. Yet, nonsmoked nicotine, including from NRT medications of patch and nasal spray, may act more selectively across rewards, perhaps due to lower dosing exposure. Our results suggest that nicotine via NRT enhances responding for visual (video) reward, but not from auditory (music) reward, just as in prior results using e-cigarettes. Withdrawal relief from NRT was unrelated to reinforced responding, consistent with positive (and not negative) reinforcement from this nicotine. Further research evaluating the dose-response effects of nicotine may clarify differences in enhanced reinforcement depending on the type of available reward.",2019,"Relative to placebo, reinforced responding due to nicotine via spray or patch was greater for video reward (both p < .01) but not for music reward (both p > .10).",['Nontreatment seeking smokers (N = 31'],"['nicotine', 'placebo', 'placebo patch plus placebo spray', 'NRT spray', 'Nicotine', 'nicotine patch (Nicoderm 14 mg) plus placebo spray, (2) placebo patch plus nicotine spray (Nicotrol', 'Via Patch and Nasal Spray', 'NRT', 'nicotine via NRT', 'nicotine via NRT patch or nasal spray']",['Withdrawal relief'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0722099', 'cui_str': 'Nicotrol'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}]","[{'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",31.0,0.131283,"Relative to placebo, reinforced responding due to nicotine via spray or patch was greater for video reward (both p < .01) but not for music reward (both p > .10).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': 'Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Boldry', 'Affiliation': 'Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty038']
323,32170769,Bortezomib consolidation or maintenance following immunochemotherapy and autologous stem cell transplantation for mantle cell lymphoma: CALGB/Alliance 50403.,"Immunochemotherapy followed by autologous transplant (ASCT) in CALGB/Alliance 59909 achieved a median progression-free survival (PFS) in mantle cell lymphoma (MCL) of 5 years, but late recurrences occurred. We evaluated tolerability and efficacy of adding post-transplant bortezomib consolidation (BC) or maintenance (BM) to this regimen in CALGB/Alliance 50403, a randomized phase II trial. Following augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab, patients were randomized to BC (1.3 mg/m 2  IV days 1, 4, 8, 11 of a 3-week cycle for four cycles) or BM (1.6 mg/m 2  IV once weekly × 4 every 8 weeks for 18 months) beginning day 90. The primary endpoint was PFS, measured from randomization for each arm. Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow were assessed. Of 151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized. Both arms met the primary endpoint, with median PFS significantly greater than 4 years (P < .001). The 8-year PFS estimates in the BC and BM arms were 54.1% (95% CI 40.9%-71.5%) and 64.4% (95% 51.8%-79.0%), respectively. Progression-free survival was significantly longer for transplanted patients on 50403 compared with those on 59909. Both the PFS and OS were significantly better for those who were MRD-negative post-induction. The high risk proliferation signature was associated with adverse outcome. Both BM and BC were efficacious and tolerable, although toxicity was significant. The comparison between studies 50403 and 59909 with long-term follow up suggests a PFS benefit from the addition of BC or BM post- transplant.",2020,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","['151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized']","['Immunochemotherapy and Autologous Stem Cell Transplantation', 'Immunochemotherapy followed by autologous transplant (ASCT', 'adding post-transplant bortezomib consolidation (BC) or maintenance (BM', 'Bortezomib Consolidation or Maintenance', 'augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab']","['8-year PFS estimates', 'Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow', 'PFS and OS', 'toxicity', 'median progression-free survival (PFS', 'PFS', 'tolerability and efficacy', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",151.0,0.0888476,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'Medicine/Hematology-Oncology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Fulton', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pettinger', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'LaCasce', 'Affiliation': 'Medical Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Yi Tian', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hurd', 'Affiliation': 'Hematology-Oncology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'Alliance Statistics and Data Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hernandez-Ilizaliturri', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department of Medicine, Weill Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Hematology-Oncology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",American journal of hematology,['10.1002/ajh.25783']
324,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND


Better understanding about gastric cancer incidence patterns among Hispanics by birthplace, socioeconomic status (SES), and acculturation can improve preventive strategies and disease models.
METHODS


Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer were calculated by age, sex, and nativity among Hispanics using California Cancer Registry data from 1988 through 2004. Incidence rates in 1998 to 2002 were compared by neighborhood SES and Hispanic enclave status according to 2000 US Census data.
RESULTS


Incidence rates of diffuse gastric cancer increased from 1988 through 2004 among foreign-born Hispanic men (EAPC: 3.5%, 95% CI: 1.5%-5.5%) and U.S.-born Hispanic women (EAPC: 3.0%, 95% CI: 0.7%-5.3%). During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women. Noncardia and both intestinal and diffuse gastric cancer were more common in foreign-born than U.S.-born Hispanic men and women, and in those from lower SES, higher enclave neighborhoods. By contrast, among younger and middle-aged Hispanic men, cardia tumors were more common in the U.S.-born than the foreign-born, and in higher SES, lower enclave neighborhoods.
CONCLUSIONS


Varying gastric cancer risk factors among Hispanic subgroups and increasing rates of diffuse gastric cancer in foreign-born Hispanic men and U.S.-born Hispanic women merit further investigation to identify separate disease etiologies.
IMPACT


Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
325,32246224,"A randomized, phase 2 study of deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone in patients with advanced non-small-cell lung cancer.","Introduction TAS-114 is a potent inhibitor of deoxyuridine triphosphatase, which is a gatekeeper protein preventing uracil and 5-fluorouracil (5-FU) misincorporation into DNA. TAS-114 has been suggested to enhance the antitumor activity of 5-FU. This randomized, phase 2 study investigated TAS-114 plus S-1 (TAS-114/S-1) vs. S-1 in non-small-cell lung cancer (NSCLC) patients. Methods Patients with advanced NSCLC, previously treated with ≥ 2 regimens, were randomized 1:1 to receive TAS-114 (400 mg)/S-1 (30 mg/m 2 ) or S-1 (30 mg/m 2 ). Progression-free survival (PFS, independent central review) was the primary endpoint. Secondary endpoints included disease control rate (DCR), overall survival (OS), overall response rate (ORR), and safety. Results In total, 127 patients received treatment. Median PFS was 3.65 and 4.17 months in the TAS-114/S-1 and S-1 groups, respectively (hazard ratio [HR] 1.16, 95% confidence interval [CI] 0.71-1.88; P = 0.2744). DCR was similar between groups (TAS-114/S-1 80.3%, S-1 75.9%) and median OS was 7.92 and 9.82 months for the TAS-114/S-1 and S-1 groups, respectively (HR 1.31, 95% CI 0.80-2.14; P = 0.1431). The ORR was higher in the TAS-114/S-1 group than the S-1 group (19.7% vs. 10.3%), and more patients with tumor shrinkage were observed in the TAS-114/S-1 group. Incidence rates of anemia, skin toxicities, and Grade ≥ 3 treatment-related adverse events were higher in the TAS-114/S-1 group compared with the monotherapy group. Conclusions Although the TAS-114/S-1 combination improved the response rate, this did not translate into improvements in PFS. Clinical Trial Registration No. NCT02855125 (ClinicalTrials.gov) registered on 4 August 2016.",2020,"DCR was similar between groups (TAS-114/S-1 80.3%, S-1 75.9%) and median OS was 7.92 and 9.82 months for the TAS-114/S-1 and S-1 groups, respectively (HR 1.31, 95% CI 0.80-2.14; P = 0.1431).","['127 patients received treatment', 'Methods Patients with advanced NSCLC, previously treated with ≥\u20092 regimens', 'non-small-cell lung cancer (NSCLC) patients', 'patients with advanced non-small-cell lung cancer']","['TAS-114/S-1', 'TAS-114', 'TAS-114 plus S-1 (TAS-114/S-1) vs. S-1', 'deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone']","['Incidence rates of anemia, skin toxicities, and Grade\u2009≥\u20093 treatment-related adverse events', 'tumor shrinkage', 'ORR', 'response rate', 'disease control rate (DCR), overall survival (OS), overall response rate (ORR), and safety', 'median OS', 'Progression-free survival (PFS, independent central review', 'DCR', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0207199', 'cui_str': 'dUTP pyrophosphatase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]",,0.360125,"DCR was similar between groups (TAS-114/S-1 80.3%, S-1 75.9%) and median OS was 7.92 and 9.82 months for the TAS-114/S-1 and S-1 groups, respectively (HR 1.31, 95% CI 0.80-2.14; P = 0.1431).","[{'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Third Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama Prefecture, 641-8509, Japan. nbyamamo@wakayama-med.ac.jp.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Department of Medical Oncology, Thoracic Group, Institut Gustave Roussy, 114 rue Édouard- Vaillant, Villejuif Cedex, 94805, France.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Morán', 'Affiliation': 'Medical Oncology, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Universitat Autonoma de Barcelona (UAB), B-ARGO, Carretera de Canyet s/n, Badalona, Barcelona, 08916, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Gregorc', 'Affiliation': 'Department of Oncology, Division of Experimental Medicine, IRCCS Ospedale San Raffaele, Via Olgettina, 60, Milano, 20132, Italy.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Dowell', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, USA.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Department of Thoracic Oncology, Saitama Cancer Center, 780 Komuro, Ina, Kita-Adachi, Saitama, 362-0806, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Cortot', 'Affiliation': 'Thoracic Oncology Department, Centre Hospitalier Universitaire de Lille, 2 Avenue Oscar Lambret, Lille, 59000, France.'}, {'ForeName': 'Karim A', 'Initials': 'KA', 'LastName': 'Benhadji', 'Affiliation': 'Department of Clinical Development, Taiho Oncology, Inc, 101 Carnegie Center, Suite 101, Princeton, NJ, 08540, USA.'}, {'ForeName': 'Nital', 'Initials': 'N', 'LastName': 'Soni', 'Affiliation': 'Department of Clinical Development, Taiho Oncology, Inc, 101 Carnegie Center, Suite 101, Princeton, NJ, 08540, USA.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacovigilance, Taiho Pharmaceutical Co., Ltd, 1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo, 101-8444, Japan.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Makris', 'Affiliation': 'Stathmi, Inc, 125 Brownsburg Rd, New Hope, PA, 18938, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Cedres', 'Affiliation': ""Medical Oncology Department, Vall d´Hebron University Hospital/Vall d´Hebron Institute of Oncology, Passeig de la Vall d'Hebron 119-129, Barcelona, 08035, Spain.""}]",Investigational new drugs,['10.1007/s10637-020-00930-5']
326,32238341,Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time.
OBJECTIVE


The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial.
METHODS


The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair.
RESULTS


This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020.
CONCLUSIONS


A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/15029.",2020,Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling.,"['Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP', 'Kenya (PUMA', 'in hair', 'women on PrEP', 'women on PrEP in Kenya']","['intervention of providing real-time feedback via the assay versus standard of care adherence counseling', 'Tenofovir', 'tenofovir', 'oral tenofovir-disoproxil-fumarate/emtricitabine']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C1070653', 'cui_str': 'Genus Puma'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]",[],,0.233658,Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drain', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngure', 'Affiliation': 'Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mugo', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Spinelli', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'Purba', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, CA, United States.'}]",JMIR research protocols,['10.2196/15029']
327,31431654,Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.,"OBJECTIVE


Extremely low birth weight children are at high risk for cognitive impairment.
STUDY DESIGN


Cognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.
RESULT


Higher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.
CONCLUSION


Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.",2019,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"['extremely low birth weight infants', 'extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed', 'extremely low birth weight children']",[],"['Cognitive outcome', 'Higher Family Resource Scale scores', 'cognitive scores']","[{'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0599714,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Fuller', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA. mfuller@sandiego.edu.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Vaucher', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Women, and Infants Hospital, Brown University, Providence, RI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0462-2']
328,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
329,31872340,Sequential Introduction of Exercise First Followed by Nutrition Improves Program Adherence During Pregnancy: a Randomized Controlled Trial.,"BACKGROUND


Adhering to nutrition and exercise recommendations simultaneously during pregnancy may be challenging. The purpose was to examine adherence to the sequential introduction of nutrition and exercise behaviors during pregnancy in comparison with a simultaneous approach.
METHOD


A randomized controlled trial including nutrition and exercise was executed. Using a stratified body mass index (BMI) randomization, participants (n = 88) were allocated to one of three groups at 12-18 weeks gestation. Group A received nutrition and exercise simultaneously. Group B received nutrition first and Group C received exercise first, and the second behavior was added at 25 weeks gestation for both groups. The program included weekly weighing, supervised walking sessions, and/or nutrition counseling. Adherence (primary outcome) was measured by scoring women on meeting the intervention goals (3 nutrition and 3 exercise goals) and converted to a percentage. Secondary health outcomes were gestational weight gain (GWG) and excessive GWG on the program, birthweight, macrosomia (birthweight > 4000 g), and low birthweight (birthweight < 2500 g).
RESULTS


Group C (n = 23) had the highest adherence to the program (80.2 ± 14.7%) compared with Groups A (n = 17; 60.9 ± 17.9%) and B (n = 20; 66.8 ± 16.7%; p < 0.05, η p 2  = 0.26). There was a significant effect for gestational weight gain (p < 0.05; η p 2  = 0.10) as Group C gained less weight (7.7 ± 2.2 kg) over Group B (9.8 ± 2.8 kg; p = 0.04), however, not Group A (9.1 ± 3.5, p = 0.35). Non-significant small effects favored Group C for the prevention of EGWG (Cramer's V = 0.13).
CONCLUSION


Introducing exercise first followed by nutrition at 25 weeks gestation can improve adherence to multiple behavior change programs and thus have a positive effect on health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02804061.",2020,"There was a significant effect for gestational weight gain (p < 0.05; η p 2  = 0.10) as Group C gained less weight (7.7 ± 2.2 kg) over Group B (9.8 ± 2.8 kg; p = 0.04), however, not Group A (9.1 ± 3.5, p = 0.35).","['4000\xa0g), and low birthweight (birthweight <\u20092500\xa0g']","['nutrition and exercise', 'Exercise', 'nutrition and exercise simultaneously', 'weighing, supervised walking sessions, and/or nutrition counseling']","['gestational weight gain', 'gestational weight gain (GWG) and excessive GWG on the program, birthweight, macrosomia ', 'Program Adherence', 'birthweight ']","[{'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}]","[{'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}]",,0.127356,"There was a significant effect for gestational weight gain (p < 0.05; η p 2  = 0.10) as Group C gained less weight (7.7 ± 2.2 kg) over Group B (9.8 ± 2.8 kg; p = 0.04), however, not Group A (9.1 ± 3.5, p = 0.35).","[{'ForeName': 'Taniya S', 'Initials': 'TS', 'LastName': 'Nagpal', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'School of Kinesiology, Faculty of Health Sciences, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Christina G', 'Initials': 'CG', 'LastName': 'Campbell', 'Affiliation': 'Department of Food Science and Human Nutrition, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Barbra', 'Initials': 'B', 'LastName': 'de Vrijer', 'Affiliation': ""Children's Health Research Institute, University of Western Ontario, London, Ontario, Canada.""}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bgeginski', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Hosein', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Paplinskie', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Manley', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada.'}, {'ForeName': 'Michelle F', 'Initials': 'MF', 'LastName': 'Mottola', 'Affiliation': 'R. Samuel McLaughlin Foundation-Exercise and Pregnancy Laboratory, University of Western Ontario, 2245, 3-M Centre, London, Ontario, N6A 3K7, Canada. mmottola@uwo.ca.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09840-0']
330,32236442,Exercising before a nap benefits memory better than napping or exercising alone.,"Sleep leads to the enhancement of memory, and physical exercise also improves memory along with beneficial effects on sleep quality. Potentially, sleep and exercise may operate independently upon memory; alternatively, they may operate synergistically to boost memory above and beyond exercise or sleep alone. We tested this hypothesis in 115 young healthy adults (23 ± 3.9 years) randomly allocated to one of the four conditions in a 2 (exercise vs. no exercise) × 2 (nap vs. no nap) design. The exercise intervention consisted of a 40-minute, moderate intensity cycling, while the no exercise condition was an equivalent period of rest. This was followed by a learning session in which participants memorized a set of 45 neutral pictures for a later test. Subsequently, participants were exposed to either a 60-minute sleep period (nap) or an equivalent time of resting wakefulness, followed by a visual recognition test. We found a significant interaction between the effects of exercise and nap (p = 0.014, η p2 = 0.053), without significant main effects of exercise or nap conditions. Participants who experienced both exercise plus nap were significantly more accurate (83.8 ± 2.9) than those who only napped (81.1 ± 5.4, p = 0.027) and those who only exercised (78.6 ± 10.3, p = 0.012). Within the combined nap plus exercise group, higher recognition accuracies were associated with higher sleep spindle densities (r = 0.46, p = 0.015). Our results demonstrate that short-term exercise and a nap improve recognition memory over a nap or exercise alone. Exercise and sleep are not independent factors operating separately upon memory but work together to enhance long-term memory.",2020,"Participants who experienced both exercise plus nap were significantly more accurate (83.8±2.9) than those who only napped (81.1±5.4, p=0.027) and those who only exercised (78.6±10.3, p=0.012).",['115 young healthy adults (23±3.9 years'],"['60-min sleep period (nap) or an equivalent time of resting wakefulness, followed by a visual recognition test', 'exercise intervention consisted of a 40-min, moderate-intensity cycling, while the no exercise condition', 'napping or exercising alone', '2 (exercise vs no exercise']","['recognition memory', 'sleep spindle densities', 'higher recognition accuracies', 'sleep quality']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",115.0,0.0475359,"Participants who experienced both exercise plus nap were significantly more accurate (83.8±2.9) than those who only napped (81.1±5.4, p=0.027) and those who only exercised (78.6±10.3, p=0.012).","[{'ForeName': 'Melodee', 'Initials': 'M', 'LastName': 'Mograss', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Crosetta', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Abi-Jaoude', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Frolova', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Edwin M', 'Initials': 'EM', 'LastName': 'Robertson', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Pepin', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Thien Thanh', 'Initials': 'TT', 'LastName': 'Dang-Vu', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, QC, Canada.'}]",Sleep,['10.1093/sleep/zsaa062']
331,31535613,"Fatigue in patients on oral targeted or chemotherapy for cancer and associations with anxiety, depression, and quality of life.","OBJECTIVES


Oral treatment (targeted or chemotherapy) for cancer is being increasingly used. While fatigue is a known side effect of intravenous chemotherapy, the rate of fatigue and the impact of fatigue on other patient-reported outcomes are not well described.
METHOD


At Massachusetts General Hospital Cancer Center, 180 adult patients prescribed oral targeted or chemotherapy for various malignancies enrolled in a randomized controlled trial of adherence and symptom management. Patients completed baseline self-reported measures of fatigue (Brief Fatigue Inventory; BFI), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale; HADS), and quality of life, including subscales for physical, social, emotional, and functional well-being ([QOL] Functional Assessment of Cancer Therapy - General; FACT-G). We examined clinically relevant fatigue using a validated cut-off score for moderate-severe fatigue (BFI global fatigue ≥4) and tested the associations with anxiety symptoms, depressive symptoms, and QOL with independent samples t-tests.
RESULTS


At baseline, 45 of 180 participants (25.0%) reported moderate-severe fatigue. Fatigued patients experienced more anxiety symptoms (mean diff. 3.73, P < 0.001), more depressive symptoms (mean diff. 4.14, P < 0.001), and worse QOL on the total FACT-G score (mean diff. -19.58, P < 0.001) and all subscales of the FACT-G compared to patients without moderate-severe fatigue.
SIGNIFICANCE OF RESULTS


One in four patients on oral treatment for cancer experienced clinically relevant fatigue that is associated with greater anxiety and depressive symptoms and worse QOL.",2020,"-19.58, P < 0.001) and all subscales of the FACT-G compared to patients without moderate-severe fatigue.
",['180 adult patients prescribed'],['oral targeted or chemotherapy'],"['total FACT-G score', 'anxiety symptoms', 'depressive symptoms', 'fatigue (Brief Fatigue Inventory; BFI), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale; HADS), and quality of life, including subscales for physical, social, emotional, and functional well-being ([QOL] Functional Assessment of Cancer Therapy - General; FACT-G', 'anxiety, depression, and quality of life', 'moderate-severe fatigue', 'anxiety and depressive symptoms and worse QOL']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",180.0,0.10128,"-19.58, P < 0.001) and all subscales of the FACT-G compared to patients without moderate-severe fatigue.
","[{'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Poort', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}]",Palliative & supportive care,['10.1017/S147895151900066X']
332,31397726,A cluster randomized controlled trial to evaluate a resilience-based intervention for caregivers of HIV-affected children in China.,"OBJECTIVES


The Child-Caregiver-Advocacy Resilience (ChildCARE) intervention aims to enhance the psychosocial wellbeing of children affected by parental HIV by providing programing at three levels: child, caregiver, and community. The objective of the current study was to evaluate the intervention's efficacy in improving mental health and parenting outcomes for participating caregivers.
DESIGN


A cluster randomized controlled trial was used to evaluate initial efficacy of the intervention.
METHODS


A total of 790 caregivers of children affected by parental HIV were recruited from Henan, China. Caregivers and their children were randomly assigned to one-of-four intervention arms (control, child-only, child + caregiver, child + caregiver + community) to evaluate the multiple components of ChildCARE. Those assigned to receive the caregiver intervention participated in five 2-h intervention sessions designed to improve their parenting skills and enhance their ability to cope with daily stressors. Caregivers reported on their mental health and parenting behaviors at baseline, 12, 24, and 36 months, with mixed effect modeling used to examine intervention effects.
RESULTS


Caregivers who participated in the intervention reported decreased anxiety and parental stress at 12 months (P < 0.05). Participants also reported increased use of structured parenting skills (i.e., parental demandingness) at 12 and 24 months (P < 0.05). However, by 36 months, they reported significantly lower levels of parental competence (P < 0.01) than those assigned to the control condition.
CONCLUSION


Preliminary findings suggest that the caregiving component of ChildCARE yields initial improvements in some key parenting and mental health outcomes. However, the challenges of caring for children affected by HIV are complex and may require more intensive intervention to yield marked, positive changes across key caregiver outcomes.",2019,"RESULTS


Caregivers who participated in the intervention reported decreased anxiety and parental stress at 12 months (P < 0.05).","['participating caregivers', 'caregivers of HIV-affected children in China', '790 caregivers of children affected by parental HIV were recruited from Henan, China', 'Caregivers and their children', 'children affected by parental HIV by providing programing at three levels: child, caregiver, and community']","['Child-Caregiver-Advocacy Resilience (ChildCARE) intervention', 'resilience-based intervention', 'caregiver intervention participated in five 2-h intervention sessions designed to improve their parenting skills', 'four intervention arms (control, child-only, child\u200a+\u200acaregiver, child\u200a+\u200acaregiver\u200a+\u200acommunity']","['anxiety and parental stress', 'mental health and parenting behaviors', 'structured parenting skills', 'levels of parental competence', 'mental health and parenting outcomes']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",790.0,0.115828,"RESULTS


Caregivers who participated in the intervention reported decreased anxiety and parental stress at 12 months (P < 0.05).","[{'ForeName': 'Sayward E', 'Initials': 'SE', 'LastName': 'Harrison', 'Affiliation': 'Department of Health Promotion, Education, and Behavior.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Health Promotion, Education, and Behavior.'}, {'ForeName': 'JiaJia', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'International Research Center for Physical and Psychological Health of Vulnerable Populations, College of Educational Sciences, Henan University, Kaifeng.'}, {'ForeName': 'Guoxiang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychology, Henan Normal University, Xinxiang, Henan, China.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002181']
333,31397727,Evaluating a patient-centred intervention to increase disclosure and promote resilience for children living with HIV in Kenya.,"OBJECTIVE


We evaluated the impact of a patient-centred, culturally and age-appropriate disclosure counselling intervention on HIV disclosure rates among Kenyan children living with HIV.
DESIGN


A prospective, clinic-cluster randomized trial.
METHODS


We followed 285 child-caregiver dyads (children ages 10-14 years) attending eight HIV clinics (randomized to intervention or control) in Kenya. Participants at intervention clinics received intensive counselling with trained disclosure counsellors and culturally tailored materials, compared with control clinics with standard care. Disclosure was treated as a time-to-event outcome, measured on a discrete time scale, with assessments at 0, 6, 12, 18 and 24 months. Mental health and behavioural outcomes were assessed using standardized questionnaires.
RESULTS


Mean age was 12.3 years [standard deviation (SD) 1.5], 52% were girls, with average time-on-treatment of 4.5 years (SD 2.4). Between 0 and 6 months, disclosure prevalence increased from 47 to 58% in the control group and from 50 to 70% in the intervention group. Differences in disclosure were not sustained over the following 18 months. The prevalence of depression symptoms was significantly higher in the intervention than in the control group at 6 months (odds ratio 2.07, 95% confidence interval 1.01-4.25); however, there was no evidence that these differences were sustained after 6 months.
CONCLUSION


The clinic-based intervention increased disclosure of HIV status to children living with HIV in the short-term, resulting in earlier disclosures, but had less clear impacts longer-term. Although well tailored interventions may support disclosure, children may still experience increased levels of depression symptoms immediately following disclosure.",2019,"The prevalence of depression symptoms was significantly higher in the intervention than in the control group at 6 months (odds ratio 2.07, 95% confidence interval 1.01-4.25); however, there was no evidence that these differences were sustained after 6 months.
","['Kenyan children living with HIV', 'children living with HIV in Kenya', '285 child-caregiver dyads (children ages 10-14 years) attending eight HIV clinics (randomized to intervention or control) in Kenya', 'Mean age was 12.3 years [standard deviation (SD) 1.5], 52% were girls, with average time-on-treatment of 4.5 years (SD 2.4']","['patient-centred, culturally and age-appropriate disclosure counselling intervention', 'intensive counselling with trained disclosure counsellors and culturally tailored materials, compared with control clinics with standard care', 'patient-centred intervention']","['Mental health and behavioural outcomes', 'disclosure prevalence', 'prevalence of depression symptoms', 'disclosure of HIV status', 'HIV disclosure rates']","[{'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",,0.117811,"The prevalence of depression symptoms was significantly higher in the intervention than in the control group at 6 months (odds ratio 2.07, 95% confidence interval 1.01-4.25); however, there was no evidence that these differences were sustained after 6 months.
","[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Vreeman', 'Affiliation': 'Department of Health Systems Design and Global Health, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Winstone M', 'Initials': 'WM', 'LastName': 'Nyandiko', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Marete', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Mwangi', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Carole I', 'Initials': 'CI', 'LastName': 'McAteer', 'Affiliation': 'Ryan White Center for Pediatric Infectious Disease and Global Health, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Keter', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Scanlon', 'Affiliation': 'Department of Health Systems Design and Global Health, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Samuel O', 'Initials': 'SO', 'LastName': 'Ayaya', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Aluoch', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002183']
334,32233961,Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study.,"MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine intended for the prevention of invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y in individuals aged 6 weeks and above. This Phase II, randomized, open-label, multicenter, exploratory study assessed the safety and immunogenicity of MenACYW-TT compared with a quadrivalent meningococcal polysaccharide vaccine (MPSV4) in 301 healthy adults aged ≥56 y in the US (NCT01732627). Participants were randomized 2:1 to receive MenACYW-TT or MPSV4. Serum bactericidal assays using human (hSBA) or baby rabbit (rSBA) complement were used to measure functional antibodies against meningococcal serogroups A, C, W, and Y at baseline and 30 d post-vaccination. Safety data were collected up to 30 d post-vaccination. Proportions of study participants with hSBA titers ≥1:8 against serogroups A, C, W, and Y were increased at Day 30 compared with baseline in both vaccine groups. The proportions of participants with hSBA titers ≥1:8 after MenACYW-TT vaccination were comparable to those after MPSV4 vaccination for serogroups A and C (A: 93.8% vs. 85.1%; C: 74.9% vs. 62.8%) and distinctly higher than after MPSV4 for serogroups W and Y (W: 79.5% vs. 60.6%; Y: 80.5% vs. 59.6%). Proportions of participants with rSBA titers ≥1:8 were comparable between vaccine groups for all four serogroups. The reactogenicity profiles of both vaccines were similar. Most unsolicited adverse events (AEs) were of Grade 1 or Grade 2 intensity, and no serious AEs were reported. The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 y.",2020,The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 ,"['adults 56 years of age and older', 'adults aged ≥56', '301 healthy adults aged ≥56\xa0y in the US (NCT01732627']","['quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'Serum bactericidal assays using human (hSBA) or baby rabbit (rSBA', 'quadrivalent meningococcal polysaccharide vaccine (MPSV4', 'MenACYW-TT or MPSV4']","['Immunogenicity and safety', 'safety and immunogenicity', 'tolerated and immunogenic']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",301.0,0.147645,The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 ,"[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kirstein', 'Affiliation': 'Advanced Clinical Research , West Jordan, UT, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Pina', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1733868']
335,32242760,"Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial.","Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet ""app"") with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.",2020,"Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided.","['Biospecimen Research', 'three Michigan hospitals to compare two different']","['consent processes (video and interactive tablet ""app"") with standard brochure-based consent in the Michigan BioTrust for Health']","['knowledge scores', 'satisfaction, amount of information, and clarity']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}]",3.0,0.0564352,"Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided.","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rothwell', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Goldenberg', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Tarini', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Riches', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Louisa A', 'Initials': 'LA', 'LastName': 'Stark', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pries', 'Affiliation': 'Spectrum Health System, Grand Rapids, MI, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Langbo', 'Affiliation': 'InformedDNA, St. Petersburg, FL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Langen', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Botkin', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}]",Journal of empirical research on human research ethics : JERHRE,['10.1177/1556264620913455']
336,32242764,"High-Volume, Low-Concentration Intraperitoneal Bupivacaine Study in Emergency Laparoscopic Cholecystectomy: A Double-Blinded, Prospective Randomized Clinical Trial.","Background . Laparoscopic cholecystectomy (LC) often results in postoperative pain, especially in the abdomen. Intraperitoneal local anesthesia (IPLA) reduces pain after LC. Acute cholecystitis-associated inflammation, increased gallbladder wall thickness, dissection difficulties, and a longer operative time are several reasons for assuming a benefit in pain scores in urgent LC with IPLA application. The aim was to determine the postoperative analgesic efficacy of high-volume, low-dose intraperitoneal bupivacaine in urgent LC.  Materials and Methods . Fifty-seven patients who were American Society of Anesthesiologists physical status I or II were randomly assigned to receive either normal saline (control group) or intraperitoneal bupivacaine (test group) at the beginning or end of urgent LC. The primary outcome was the postoperative pain score of the Visual Analogue Scale (VAS). The secondary outcomes included Visual Rating Prince Henry Scale (VRS), patient satisfaction, and analgesic consumption.  Results . Postoperative VAS scores at the first and fourth hours were significantly lower in the test group than in the control group ( P  < .001). Postoperative VRS scores at the first, fourth, and eighth hours were significantly lower in the test group than in the control group ( P  < .001,  P  = .002,  P  = .004, respectively). Analgesic use was significantly higher in the control group at the first postoperative hour ( P  < .001). Shoulder pain was significantly lower, and patient satisfaction was significantly higher in the test group relative to the control group (both  P  < .001).  Conclusion . High-volume, low-concentration intraperitoneal bupivacaine resulted in better postoperative pain control and reduced incidence of shoulder pain and analgesic consumption in urgent LC.",2020,"High-volume, low-concentration intraperitoneal bupivacaine resulted in better postoperative pain control and reduced incidence of shoulder pain and analgesic consumption in urgent LC.","['Emergency Laparoscopic Cholecystectomy', 'Fifty-seven patients who were American Society of Anesthesiologists physical status']","['high-volume, low-dose intraperitoneal bupivacaine', 'normal saline (control group) or intraperitoneal bupivacaine', 'Intraperitoneal local anesthesia (IPLA', 'bupivacaine', 'Laparoscopic cholecystectomy (LC']","['Analgesic use', 'postoperative pain control', 'Postoperative VAS scores', 'Visual Rating Prince Henry Scale (VRS), patient satisfaction, and analgesic consumption', 'shoulder pain and analgesic consumption', 'Acute cholecystitis-associated inflammation, increased gallbladder wall thickness, dissection difficulties', 'patient satisfaction', 'postoperative pain score of the Visual Analogue Scale (VAS', 'Shoulder pain', 'postoperative analgesic efficacy', 'Postoperative VRS scores']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C2830173', 'cui_str': 'Calcium-Independent Phospholipase A2'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582517', 'cui_str': 'henry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}]",57.0,0.171857,"High-volume, low-concentration intraperitoneal bupivacaine resulted in better postoperative pain control and reduced incidence of shoulder pain and analgesic consumption in urgent LC.","[{'ForeName': 'Alpen', 'Initials': 'A', 'LastName': 'Yahya Gumusoglu', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Ferahman', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Emin', 'Initials': 'ME', 'LastName': 'Gunes', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Surek', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serhan', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Husnu', 'Initials': 'H', 'LastName': 'Aydin', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Abdul Celil', 'Initials': 'AC', 'LastName': 'Gezmis', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Zumrud', 'Initials': 'Z', 'LastName': 'Aliyeva', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Donmez', 'Affiliation': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}]",Surgical innovation,['10.1177/1553350620914198']
337,32238795,Longitudinal effects of a nurse-managed comprehensive cardiovascular disease prevention program for hospitalized coronary heart disease patients and primary care high-risk patients.,"BACKGROUND


The EUROACTION study (nurse‑coordinated multidisciplinary, family‑based cardiovascular disease prevention program) documented the efficacy of a nurse‑managed, comprehensive prevention program in reducing risk factors for cardiovascular disease (CVD). No information was available on survival.
AIMS


The aim of the study was to assess the effects of EUROACTION intervention on CVD risk factors and 12‑year survival in the Polish component of the study.
METHODS


Two district hospitals and 2 primary care practices were allocated randomly to intervention (INT) or usual care (UC). The primary endpoints were lifestyle and risk factors changes at 1‑year follow‑up. Differences in survival were analyzed using the multivariable Cox proportional hazards regression models.
RESULTS


The study involved 628 patients with coronary heart disease (CHD) and 711 high‑risk patients. Compared to UC, INT patients achieved healthier lifestyles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after the intervention. Less deaths occurred in patients from the INT hospital and from INT primary practice (hazard ratio [HR], 0.58; 95% CI, 0.42-0.82 and HR, 0.53; 95% CI, 0.3-0.95, respectively). Adjustment for the covariates slightly attenuated the estimates and removed significance (HR, 0.74; 95% CI, 0.52-1.04 and HR, 0.66; 95% CI, 0.36-1.24, respectively). For combined CHD and high‑risk patient groups, compared with UC, INT patients had a 36% lower risk of death after adjustment for age, sex, and history of CHD (HR, 0.64; 95% CI, 0.48-0.86).
CONCLUSIONS


The impact of the EUROACTION intervention on lifestyle and CVD risk factors could have contributed to lower mortality in INT coronary and high‑risk patients. These results emphasize the need for sustaining the interventions to help patients maintain a healthy lifestyle.",2020,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","['Two district hospitals and two primary practices', '628 CHD patients and 601 high-risk patients', 'hospitalized coronary heart disease patients and primary care high-risk patients']","['nurse managed, comprehensive prevention programme', 'nurse-managed comprehensive cardiovascular disease prevention programme', 'intervention (INT) or usual care (UC']","['survival', 'healthier life styles', 'Less deaths', 'CVD risk factors', 'risk factors', 'lifestyle and risk factors changes at 1 year observation', 'risk of death']","[{'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",628.0,0.0552067,"Compared to UC, INT patients achieved healthier life styles and a larger reduction of risk factors at 1 year but these differences were not maintained 12 years after intervention.","[{'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Pająk', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland. andrzej.pajak@uj.edu.pl'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Wolfshaut-Wolak', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Doryńska', 'Affiliation': 'Department of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Jankowski', 'Affiliation': '1st Department of Cardiology and Intervention Electrocardiology and Hypertension, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fornal', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grodzicki', 'Affiliation': 'Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Jennings', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}, {'ForeName': 'Kalina', 'Initials': 'K', 'LastName': 'Kawecka-Jaszcz', 'Affiliation': '1st Department of Cardiology and Intervention Electrocardiology and Hypertension, Jagiellonian University Medical College, Kraków, Poland'}, {'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Kotseva', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Pająk', 'Affiliation': 'Centre of Preventive Medicine, Kraków, Poland'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wood', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; National Institute for Prevention and Cardiovascular Health, National University of Ireland, Galway, Republic of Ireland'}]",Kardiologia polska,['10.33963/KP.15273']
338,31257430,Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial.,"BACKGROUND


Preterm constitutes a major part of neonatal mortality, particularly in India. Due to dermal immaturity, preterm neonates are susceptible to various complications like infection, hypothermia, etc. Emollient application is a traditional practice in our subcontinent.
AIMS


To find out the efficacy of coconut oil application for skin maturity, prevention of sepsis, hypothermia and apnea, its effect on long-term neurodevelopment and adverse effect of it, if any.
MATERIAL AND METHODS


A randomized controlled trial was conducted in the rural field practice area of Department of Community Medicine, Burdwan Medical College from March 2014 to August 2018. Preterm born in the study period was divided into Group A (received virgin coconut oil application) and Group B (received body massage without any application). Neonatal skin condition was assessed on 7th, 14th, 21st and 28th day of life. Neurodevelopmental status was assessed on 3rd, 6th and 12th months.
RESULTS


A total of 2294 preterm were included in the study. Groups A and B consisted of 1146 and 1148 preterm infants, consecutively. Mean gestational age of the study population was 31.9 ± 3.4 weeks and 50.4% were male. Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application.
CONCLUSION


Use of coconut oil helps in dermal maturity and better neurodevelopmental outcome. Further studies are warranted for universal recommendation.",2020,"Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application.
","['rural field practice area of Department of Community Medicine, Burdwan Medical College from March 2014 to August 2018', 'Groups A and B consisted of 1146 and 1148 preterm infants, consecutively', 'Preterm Newborns', 'Mean gestational age of the study population was 31.9\u2009±\u20093.4\u2009weeks and 50.4% were male', 'A total of 2294 preterm were included in the study']","['Virgin Coconut Oil Application', 'coconut oil application', 'coconut oil', 'virgin coconut oil application) and Group B (received body massage without any application']","['Neurodevelopmental status', 'dermal maturity and better neurodevelopmental outcome', 'Mean weight loss', 'Neonatal skin condition', 'hypothermia and apnea, and better skin maturity and neurodevelopmental outcome', 'mean weight gain', 'adverse effect']","[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0009473', 'cui_str': 'Community Medicine'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0056060', 'cui_str': 'Coconut Oil'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0556844', 'cui_str': 'Body massage (regime/therapy)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449989', 'cui_str': 'Maturity (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",2294.0,0.067879,"Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application.
","[{'ForeName': 'Mithun Chandra', 'Initials': 'MC', 'LastName': 'Konar', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}, {'ForeName': 'Kamirul', 'Initials': 'K', 'LastName': 'Islam', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}, {'ForeName': 'Taraknath', 'Initials': 'T', 'LastName': 'Ghosh', 'Affiliation': 'Department of Pediatrics, Burdwan Medical College, Burdwan, West Bengal 713104, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz041']
339,31718918,Postoperative stability of conventional bimaxillary surgery compared with maxillary impaction surgery with mandibular autorotation for patients with skeletal class II retrognathia.,"We aimed to compare the postoperative stability of conventional bimaxillary surgery (with bilateral sagittal split osteotomy) with that of maxillary impaction surgery (with mandibular autorotation without bilateral sagittal split osteotomy) in patients with skeletal class II retrognathia. Patients were assigned to have conventional bimaxillary surgery (conventional group, n=6) or mandibular autorotation (experimental group, n=7). Measurements were made using serial lateral cephalometric radiographs taken immediately preoperatively (T0), immediately postoperatively (T1), and one year later (T2) to assess the variation in operative change (T1-T0) and relapse (T2-T1). There was no significant difference in median (range) surgical change in the anterior movement at point B (conventional group, 4.5 (3.0-11.0) mm; experimental group 4.1 (2.1-6.4) mm). However, there was a significant difference in median (range) surgical posterior movement relapse at point B (conventional group -1.7 (-2.3 to -0.5) mm; experimental group -0.6 (-1.0 to 1.0) mm; p=0.032). Mandibular advancement with mandibular autorotation is therefore a more stable procedure than mandibular advancement with bilateral sagittal split osteotomy in patients with skeletal class II retrognathia.",2020,Mandibular advancement with mandibular autorotation is therefore a more stable procedure than mandibular advancement with bilateral sagittal split osteotomy in patients with skeletal class II retrognathia.,['patients with skeletal class II retrognathia'],"['bilateral sagittal split osteotomy', 'maxillary impaction surgery with mandibular autorotation', 'conventional bimaxillary surgery', 'conventional bimaxillary surgery (with bilateral sagittal split osteotomy', 'maxillary impaction surgery (with mandibular autorotation without bilateral sagittal split osteotomy', 'conventional bimaxillary surgery (conventional group, n=6) or mandibular autorotation']","['operative change (T1-T0) and relapse (T2-T1', 'median (range) surgical posterior movement relapse', 'Postoperative stability', 'median (range) surgical change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C3494422', 'cui_str': 'Retrognathias'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",,0.0548723,Mandibular advancement with mandibular autorotation is therefore a more stable procedure than mandibular advancement with bilateral sagittal split osteotomy in patients with skeletal class II retrognathia.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kita', 'Affiliation': 'Department of Orthodontic Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan. Electronic address: s.kita.orts@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Yokohama City University Medical Centre, Kanagawa, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Yokohama City University Medical Centre, Kanagawa, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aoyagi', 'Affiliation': 'Department of Orthodontic Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shimazaki', 'Affiliation': 'Department of Orthodontic Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Yonemitsu', 'Affiliation': 'Department of Orthodontic Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Omura', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Yokohama City University Medical Centre, Kanagawa, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Department of Orthodontic Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2019.10.309']
340,32243865,"Efficacy and safety of landiolol, an ultra-short-acting β1-selective antagonist, for treatment of sepsis-related tachyarrhythmia (J-Land 3S): a multicentre, open-label, randomised controlled trial.","BACKGROUND


Tachycardia and atrial fibrillation frequently occur in patients being treated for sepsis or septic shock and have a poor prognosis. Treatments for tachyarrhythmias are often ineffective or contraindicated in this setting. We aimed to investigate the efficacy and safety of landiolol, an ultra-short-acting β-blocker, for treating sepsis-related tachyarrhythmias.
METHODS


We did a multicentre, open-label, randomised controlled trial at 54 hospitals in Japan. Patients admitted to the intensive care units who received conventional treatment for sepsis, according to clinical guidelines for the management of sepsis, and who subsequently developed a tachyarrhythmia, were enrolled. The main inclusion criteria were 20 years of age or older, diagnosis of sepsis according to Third International Consensus Definitions for Sepsis and Septic Shock criteria, administration of catecholamine necessary to maintain mean arterial pressure at 65 mm Hg or more for at least 1 h, and heart rate of 100 beats per min (bpm) or more maintained for at least 10 min without a change in catecholamine dose with diagnosis of atrial fibrillation, atrial flutter, or sinus tachycardia. Only patients who developed these symptoms and signs within 24 h before randomisation, and within 72 h after entering an intensive care unit, were prospectively assigned to receive conventional sepsis therapy alone (control group) or conventional sepsis therapy plus landiolol (landiolol group) in an open-label manner. Landiolol hydrochloride was intravenously infused at an initial dose of 1 μg/kg per min within 2 h after randomisation and the dose could be increased per study protocol to a maximum of 20 μg/kg per min. Patients in both groups received conventional therapy (Japanese Clinical Practice Guidelines for the Management of Sepsis and Septic Shock 2016), including respiratory and fluid resuscitation, antimicrobials, and catecholamines. The treating physicians were required to stabilise the patient's haemodynamic status before randomisation. Randomisation was done using a central randomisation system and dynamic allocation with the minimisation method by institution, heart rate at randomisation (≥100 to <120 bpm or ≥120 bpm), and age (<70 years or ≥70 years). The primary outcome was the proportion of patients with heart rate of 60-94 bpm at 24 h after randomisation. Patients without heart rate data at 24 h after randomisation were handled as non-responders. The primary outcome was analysed using the full analysis set on an as-assigned basis, while safety was analysed using the safety analysis set according to the treatment received. This study was registered with the Japan Pharmaceutical Information Center Clinical Trials Information database, number JapicCTI-173767.
FINDINGS


Between Jan 16, 2018 and Apr 22, 2019, 151 patients were randomly assigned, 76 to the landiolol group and 75 to the control group. A significantly larger proportion of patients in the landiolol group had a heart rate of 60-94 bpm 24 h after randomisation than in the control group (55% [41 of 75] vs 33% [25 of 75]), with a between-group difference of 23·1% (95% CI 7·1-37·5; p=0·0031). Adverse events were observed in 49 (64%) of 77 patients in the landiolol group and in 44 (59%) of 74 in the control group, with serious adverse events (including adverse events leading to death) in nine (12%) of 77 and eight (11%) of 74 patients. Serious adverse events related to landiolol occurred in five (6%) of 77 patients, including blood pressure decreases in three patients (4%) and cardiac arrest, heart rate decrease, and ejection fraction decrease occurred in one patient each (1%).
INTERPRETATION


Landiolol resulted in significantly more patients with sepsis-related tachyarrhythmia achieving a heart rate of 60-94 bpm at 24 h and significantly reduced the incidence of new-onset arrhythmia. Landiolol was also well tolerated, but it should be used under appropriate monitoring of blood pressure and heart rate owing to the risk of hypotension in patients with sepsis and septic shock.
FUNDING


Ono Pharmaceutical Co.",2020,"A significantly larger proportion of patients in the landiolol group had a heart rate of 60-94 bpm 24 h after randomisation than in the control group (55% [41 of 75] vs 33% [25 of 75]), with a between-group difference of 23·1% (95% CI 7·1-37·5; p=0·0031).","['54 hospitals in Japan', 'Patients admitted to the intensive care units who received conventional treatment for sepsis, according to clinical guidelines for the management of sepsis, and who subsequently developed a tachyarrhythmia, were enrolled', 'The main inclusion criteria were 20 years of age or older, diagnosis of sepsis according to Third International Consensus Definitions for Sepsis and Septic Shock criteria, administration of catecholamine necessary to maintain mean arterial pressure at 65 mm Hg or more for at least 1 h, and heart rate of 100 beats per min (bpm) or more maintained for at least 10 min without a change in catecholamine dose with diagnosis of atrial fibrillation, atrial flutter, or sinus tachycardia', 'Between Jan 16, 2018 and Apr 22, 2019', '151 patients', 'Only patients who developed these symptoms and signs within 24 h before randomisation, and within 72 h after entering an intensive care unit', 'patients with sepsis and septic shock', 'patients being treated for sepsis or septic shock']","['Landiolol hydrochloride', 'landiolol', 'conventional sepsis therapy alone (control group) or conventional sepsis therapy plus landiolol (landiolol group) in an open-label manner', 'conventional therapy (Japanese Clinical Practice Guidelines', 'landiolol, an ultra-short-acting β1-selective antagonist']","['incidence of new-onset arrhythmia', 'heart rate', 'proportion of patients with heart rate', 'blood pressure decreases', 'Adverse events', 'cardiac arrest, heart rate decrease, and ejection fraction decrease', 'serious adverse events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0039239', 'cui_str': 'Sinus tachycardia'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0743400', 'cui_str': 'Ejection fraction decreased'}]",151.0,0.299103,"A significantly larger proportion of patients in the landiolol group had a heart rate of 60-94 bpm 24 h after randomisation than in the control group (55% [41 of 75] vs 33% [25 of 75]), with a between-group difference of 23·1% (95% CI 7·1-37·5; p=0·0031).","[{'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kakihana', 'Affiliation': 'Department of Emergency and Intensive Care Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nishida', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Taniguchi', 'Affiliation': 'Intensive Care Unit, University Hospital, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Okajima', 'Affiliation': 'Intensive Care Unit, University Hospital, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morimatsu', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama City, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Anesthesiology and Pain Relief Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Clinical Development Planning, Ono Pharmaceutical Co, Osaka, Japan.'}, {'ForeName': 'Eiichiro', 'Initials': 'E', 'LastName': 'Morishima', 'Affiliation': 'Data Science, Ono Pharmaceutical Co, Osaka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Matsuda', 'Affiliation': 'Department of Emergency & Critical Care Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: nmatsuda@med.nagoya-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30037-0']
341,31741204,Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness.,"Adults with serious mental illness have high rates of obesity, with associated negative impacts on health-related quality of life. The present study utilized data from a randomized controlled trial (N = 276) to examine the effectiveness of in-person and online-delivered weight management interventions, compared to usual care, for improving health-related quality of life in this population. Participants completed quality of life assessments at baseline, 3 months, and 6 months. Mixed effects models examined group by time interactions. Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018). Web-based and in-person weight management led to improvements in health-related quality of life for adults with serious mental illness.ClinicalTrials.gov Identifier: NCT00983476.",2020,"Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018).","['adults with serious mental illness', 'Adults with serious mental illness']","['person and online-delivered weight management interventions', 'web-based and in-person weight management']","['mental health related quality of life', 'quality of life assessments', 'health-related quality of life', 'mental health-related quality of life', 'weight-related self-esteem', 'loneliness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}]",276.0,0.177496,"Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018).","[{'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Muralidharan', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA. anjana.muralidharan2@va.gov.'}, {'ForeName': 'Clayton H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Psychiatric Services Research, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Noosha', 'Initials': 'N', 'LastName': 'Niv', 'Affiliation': 'Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center (MIRECC), Long Beach, CA, USA.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kreyenbuhl', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Oberman', 'Affiliation': 'VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Goldberg', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00117-1']
342,32233338,"A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.","BACKGROUND


Obesity is a chronic disease with limited treatment options in pediatric patients. Liraglutide may be useful for weight management in adolescents with obesity.
METHODS


In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide (3.0 mg) or placebo subcutaneously once daily, in addition to lifestyle therapy. The primary end point was the change from baseline in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) standard-deviation score at week 56.
RESULTS


A total of 125 participants were assigned to the liraglutide group and 126 to the placebo group. Liraglutide was superior to placebo with regard to the change from baseline in the BMI standard-deviation score at week 56 (estimated difference, -0.22; 95% confidence interval [CI], -0.37 to -0.08; P = 0.002). A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%). A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points) and for body weight (estimated difference, -4.50 kg [for absolute change] and -5.01 percentage points [for relative change]). After discontinuation, a greater increase in the BMI standard-deviation score was observed with liraglutide than with placebo (estimated difference, 0.15; 95% CI, 0.07 to 0.23). More participants in the liraglutide group than in the placebo group had gastrointestinal adverse events (81 of 125 [64.8%] vs. 46 of 126 [36.5%]) and adverse events that led to discontinuation of the trial treatment (13 [10.4%] vs. 0). Few participants in either group had serious adverse events (3 [2.4%] vs. 5 [4.0%]). One suicide, which occurred in the liraglutide group, was assessed by the investigator as unlikely to be related to the trial treatment.
CONCLUSIONS


In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a significantly greater reduction in the BMI standard-deviation score than placebo plus lifestyle therapy. (Funded by Novo Nordisk; NN8022-4180 ClinicalTrials.gov number, NCT02918279.).",2020,"A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).","['enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone', 'Adolescents with Obesity', 'pediatric patients', 'adolescents with obesity', 'A total of 125 participants']","['Liraglutide', 'liraglutide', 'placebo', 'placebo subcutaneously once daily, in addition to lifestyle therapy']","['body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) standard-deviation score', 'BMI standard-deviation score', 'gastrointestinal adverse events', 'BMI', 'body weight', 'serious adverse events', 'adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",125.0,0.384518,"A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).","[{'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Kelly', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Auerbach', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Barrientos-Perez', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Gies', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Hale', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Lucy D', 'Initials': 'LD', 'LastName': 'Mastrandrea', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Nandana', 'Initials': 'N', 'LastName': 'Prabhu', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916038']
343,31884075,Comparing Different Music Genres in Decreasing Dental Anxiety in Young Adults Who Underwent Third Molar Surgery in Turkey: Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to determine the music genre reducing anxiety best in patients whose third molars were extracted.
MATERIALS AND METHODS


Eighty patients were included in this prospective, observational, randomized controlled trial. They were divided into 4 groups: group 1, Turkish music; group 2, classical music of a Western culture; group 3, soft rock music; and group 4, no music (control group). The preoperative blood pressure, heart rate (HR), and oxygen saturation of each patient were measured, and the Corah Dental Anxiety Scale (CDAS) questionnaire was applied, with the values being measured and recorded at 5-minute intervals. Descriptive and bivariate statistics were computed, and the P value was set at .05.
RESULTS


Of the 80 patients, 44 were women and 36 were men. The average age was 24.1 ± 5.9 years. No significant differences between the groups were found in terms of age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values (P > .05). Although no significant correlations was found between anxiety levels and age (P = .330), HR (P = .694), or mean arterial pressure (P = .775), it was detected that anxiety was high in women (P < .05). Anxiety levels decreased at all times in all groups, but the postoperative CDAS values of the classical music group were significantly lower than those of the other groups (P = .024).
CONCLUSIONS


This study found that classical Western music that was started in the preoperative period and continued until the end of the operation significantly reduced the anxiety associated with third molar extraction in patients aged between 18 and 30 years.",2020,"No significant differences between the groups were found in terms of age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values (P > .05). ","['patients whose third molars were extracted', '80 patients', 'Eighty patients', 'Young Adults', 'Who Underwent Third Molar Surgery in Turkey', '44 were women and 36 were men', 'patients aged between 18 and 30\xa0years']","['Music Genres', 'Turkish music; group 2, classical music of a Western culture; group 3, soft rock music; and group 4, no music (control group']","['Dental Anxiety', 'mean arterial pressure', 'Anxiety levels', 'preoperative blood pressure, heart rate (HR), and oxygen saturation of each patient', 'anxiety levels', 'anxiety', 'Corah Dental Anxiety Scale (CDAS) questionnaire', 'age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values', 'postoperative CDAS values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0002876', 'cui_str': 'Congenital dyserythropoietic anemia (disorder)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",80.0,0.0354906,"No significant differences between the groups were found in terms of age; gender; or preoperative HR, mean arterial pressure, oxygen saturation (as measured by pulse oximetry), and CDAS values (P > .05). ","[{'ForeName': 'Ilke', 'Initials': 'I', 'LastName': 'Kupeli', 'Affiliation': 'Associate Professor, Anesthesiology and Reanimation Department, Erzincan Binali Yıldırım University, Erzincan, Turkey. Electronic address: ilkeser2004@gmail.com.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Gülnahar', 'Affiliation': 'Assistant Professor, Oral and Maxillofacial Surgery Department, Erzincan Binali Yıldırım University, Erzincan, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.11.029']
344,32035892,Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF.,"A central factor in the pathogenesis of heart failure (HF) with reduced ejection fraction is the initial decrease in systolic function. Prior attempts at increasing cardiac contractility with oral drugs have uniformly resulted in signals of increased mortality at pharmacologically effective doses. Omecamtiv mecarbil is a novel, selective cardiac myosin activator that has been shown to improve cardiac function and to decrease ventricular volumes, heart rate, and N-terminal pro-B-type natriuretic peptide in patients with chronic HF. The GALACTIC-HF (Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure) trial tests the hypotheses that omecamtiv mecarbil can safely improve symptoms, prevent clinical HF events, and delay CV death in patients with chronic HF. The GALACTIC-HF trial is an international, multicenter, randomized, double-blind, placebo-controlled, event-driven cardiovascular outcomes trial. More than 8,000 patients with chronic symptomatic (New York Heart Association functional class II to IV) HF, left ventricular ejection fraction ≤35%, elevated natriuretic peptides, and either current hospitalization for HF or history of hospitalization or emergency department visit for HF within a year of screening will be randomized to either oral placebo or omecamtiv mecarbil employing a pharmacokinetic-guided dose titration strategy using doses of 25, 37.5, or 50 mg twice daily. The primary efficacy outcome is the time to cardiovascular death or first HF event. The study has 90% power to assess a final hazard ratio of approximately 0.80 in cardiovascular death, the first secondary outcome. The GALACTIC-HF trial is the first trial examining whether selectively increasing cardiac contractility in patients with HF with reduced ejection fraction will result in improved clinical outcomes. (Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction [GALACTIC-HF]; NCT02929329).",2020,"The study has 90% power to assess a final hazard ratio of approximately 0.80 in cardiovascular death, the first secondary outcome.","['patients with chronic HF', 'Chronic Heart\xa0Failure With Reduced Ejection Fraction', 'patients with HF with reduced ejection fraction', 'Heart\xa0Failure', '8,000 patients with chronic symptomatic (New York Heart Association functional class II to IV) HF, left ventricular ejection fraction\xa0≤35%, elevated natriuretic peptides, and either current hospitalization for HF or history of hospitalization or emergency department visit for HF within a year of screening']",['placebo'],"['clinical HF events, and delay CV death', 'time to cardiovascular death or first HF event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.242509,"The study has 90% power to assess a final hazard ratio of approximately 0.80 in cardiovascular death, the first secondary outcome.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center, School of Medicine, University of California-San Francisco, San Francisco, California. Electronic address: john.teerlink@ucsf.edu.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clinicos Latinoamérica, Rosario, Argentina.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Legg', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Büchele', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Varin', 'Affiliation': 'Servier, Suresnes, France.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics, Inc., South San Francisco, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.12.001']
345,31938877,The effect of varenicline on mood and cognition in smokers with HIV.,"RATIONALE


Barriers to smoking cessation, including negative affect and cognitive dysfunction, may contribute to high smoking rates among people living with HIV/AIDS (PLWH). Varenicline may help PLWH quit smoking by improving mood and cognition, yet this has not been explored.
OBJECTIVES


The goal of this study was to evaluate the effect of varenicline on mood and cognition among PLWH enrolled in a smoking cessation clinical trial.
METHODS


In this secondary analysis of a varenicline trial (NCT01710137), we assessed mood (depression, anxiety) and cognition (attention, working memory) at weeks 0 (baseline), 1, 3, and 12 (end-of-treatment, EOT). Primary outcomes were changes in mood and cognition from baseline to EOT. Secondarily, mood and cognition were evaluated as predictors of biochemically confirmed 7-day point-prevalence abstinence at EOT.
RESULTS


Overall, 173 subjects (87 varenicline, 86 placebo) were included. At EOT, varenicline reduced anxiety (P < 0.001), vs. placebo (P = 0.31; interaction P = 0.05). Across both treatment arms, reductions in anxiety from baseline to EOT were associated with a higher likelihood of abstinence (OR = 1.3, 95% CI 1.1 to 1.6, P = 0.01). There were no significant treatment by time interactions for cognition or depression.
CONCLUSIONS


These data suggest that varenicline operates, at least in part, by reducing anxiety. Anxiety should be an intervention target for smokers with HIV interested in quitting.",2020,"At EOT, varenicline reduced anxiety (P < 0.001), vs. placebo (P = 0.31; interaction P = 0.05).","['smokers with HIV', 'people living with HIV/AIDS (PLWH', '173 subjects (87', 'smokers with HIV interested in quitting']","['varenicline, 86 placebo', 'varenicline', 'Varenicline', 'placebo']","['changes in mood and cognition from baseline to EOT', 'reductions in anxiety', 'mood (depression, anxiety) and cognition (attention, working memory', 'Secondarily, mood and cognition', 'time interactions for cognition or depression', 'anxiety', 'mood and cognition']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",173.0,0.100971,"At EOT, varenicline reduced anxiety (P < 0.001), vs. placebo (P = 0.31; interaction P = 0.05).","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Serrano', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Pulmonary, Allergy, & Critical Care Division, Presbyterian Medical Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Division of Infectious Diseases, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Collman', 'Affiliation': 'Pulmonary, Allergy and Critical Care Division, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA. rlashare@pennmedicine.upenn.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05451-w']
346,31853772,Use of Rapid HIV Self-Test to Screen Potential Sexual Partners: Results of the ISUM Study.,"ISUM (""I'll show you mine"") was a randomized controlled trial in which 272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU) were assigned to an intervention group (n = 136), in which they had access to free HIV self-testing (ST) kits, or to a control group (n = 136). The trial aimed to determine whether the intervention group would use ST to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group. The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08). In NYC (n = 166) intervention participants had significantly fewer CAI occasions, whereas in SJU (n = 106) they reported non-significantly more CAI occasions. Two devastating hurricanes hit SJU during the study and may have impacted results in unmeasured ways.",2020,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","['Screen Potential Sexual Partners', 'to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group', '272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU']","['ST', 'ISUM (""I\'ll show you mine', 'Rapid HIV Self-Test']",['CAI occasions'],"[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",[],,0.0544861,"The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ac72@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02763-7']
347,32241619,Effects of Sacubitril/Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction.,"OBJECTIVES


The authors sought to evaluate the prognostic significance of baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP), whether NT-proBNP modified the treatment response to sacubitril/valsartan, and the treatment effect of sacubitril/valsartan on NT-proBNP overall and in key subgroups.
BACKGROUND


Sacubitril/valsartan reduces NT-proBNP in heart failure (HF) with both reduced and preserved ejection fraction (EF), but did not significantly reduce total HF hospitalizations and cardiovascular death compared with valsartan in patients with HF with preserved EF (HFpEF).
METHODS


In the PARAGON-HF (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction) trial, 4,796 patients with HFpEF and elevated NT-proBNP were randomized to sacubitril/valsartan or valsartan. NT-proBNP was measured at screening in all patients and at 5 subsequent times in >2,700 patients: before, between, and after sequential valsartan and sacubitril/valsartan run-in periods, and 16 and 48 weeks post-randomization.
RESULTS


Median NT-proBNP was 911 pg/ml (interquartile range: 464 to 1,613 pg/ml) at screening. Screening NT-proBNP was strongly associated with the primary endpoint, total HF hospitalizations and cardiovascular death (rate ratio [RR]: 1.68 per log increase in NT-proBNP, 95% confidence interval [CI]: 1.53 to 1.85; p < 0.001). This relationship was stronger in patients with atrial fibrillation (adjusted RR: 2.33 [95% CI: 1.89 to 2.87] vs. 1.58 [95% CI: 1.42 to 1.75] in patients without atrial fibrillation; p interaction <0.001) and weaker in obese patients (adjusted RR: 1.50 [95% CI: 1.31 to 1.71] vs. 1.92 [95% CI: 1.70 to 2.17] in nonobese patients; p interaction <0.001). Screening NT-proBNP did not modify the treatment effect of sacubitril/valsartan compared with valsartan (p interaction = 0.96). Sacubitril/valsartan reduced NT-proBNP by 19% (95% CI: 14% to 23%; p < 0.001) compared with valsartan 16 weeks post-randomization, with similar reductions in men (20%) and women (18%), and in patients with left ventricular EF ≤57% (20%) and >57% (18%). Decreases in NT-proBNP predicted lower subsequent risk of the primary endpoint.
CONCLUSIONS


Baseline NT-proBNP predicted HF events but did not modify the sacubitril/valsartan treatment effect in patients with HFpEF. Sacubitril/valsartan reduced NT-proBNP consistently in men and women, and in patients with lower or higher EF. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).",2020,"Screening NT-proBNP was strongly associated with the primary endpoint, total HF hospitalizations and cardiovascular death (rate ratio [RR]:","['Heart Failure', 'patients with HFpEF', 'Heart\xa0Failure Patients With Preserved Ejection Fraction) trial, 4,796 patients with HFpEF and elevated NT-proBNP', 'patients with HF with preserved EF (HFpEF']","['Sacubitril/Valsartan', 'Valsartan', 'valsartan', 'LCZ696', 'valsartan and sacubitril/valsartan', 'sacubitril/valsartan or valsartan', 'sacubitril/valsartan', 'Sacubitril/valsartan']","['NT-proBNP', 'Morbidity and Mortality', 'HF events', 'total HF hospitalizations and cardiovascular death', 'total HF hospitalizations and cardiovascular death (rate ratio [RR']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4796.0,0.231746,"Screening NT-proBNP was strongly associated with the primary endpoint, total HF hospitalizations and cardiovascular death (rate ratio [RR]:","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Cunningham', 'Affiliation': ""Brigham and Women's Hospital, Division of Cardiovascular, Boston, Massachusetts. Electronic address: https://twitter.com/JonWCunningham.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital, Division of Cardiovascular, Boston, Massachusetts. Electronic address: https://twitter.com/mvaduganathan.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Brigham and Women's Hospital, Division of Cardiovascular, Boston, Massachusetts.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'RHJ Department of Veterans Affairs Medical Center and Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'VA Medical Center and University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Centre d'Investigations Cliniques-Plurithématique 1433, and INSERM U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.""}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; The George Institute for Global Health, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kober', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Heart Failure Unit, Medanta Medicity, Gurugram, Haryana, India.'}, {'ForeName': 'Victor C', 'Initials': 'VC', 'LastName': 'Shi', 'Affiliation': 'Novartis, East Hanover, New Jersey.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis, East Hanover, New Jersey.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Novartis, East Hanover, New Jersey.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Brigham and Women's Hospital, Division of Cardiovascular, Boston, Massachusetts.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Division of Cardiovascular, Boston, Massachusetts. Electronic address: ssolomon@rics.bwh.harvard.edu.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.03.002']
348,31451438,"Individual coronary plaque changes on serial CT angiography: Within-patient heterogeneity, natural history, and statin effects in HIV.","BACKGROUND


It is not known how the volume and composition of individual coronary plaques change over time in HIV-infected people and whether statins influence these changes.
METHODS


We included forty adults with HIV and subclinical coronary atherosclerosis who participated in a randomized controlled trial of placebo vs. atorvastatin. All participants underwent serial coronary computed tomography angiography at baseline and after one year. Individual coronary plaques were measured to assess the within-patient variability of plaque volume and composition changes. Left-main, proximal-right, proximal-left-anterior descending, and proximal-circumflex coronary segments were considered proximal. Plaque voxels with attenuation ≤130 Hounsfield Units (HU) were defined as noncalcified and further divided into fatty (<40HU) and fibrotic (40-130HU) components.
RESULTS


In 37 patients who completed the trial, there were 92 coronary plaques. Individual plaque changes varied highly, with some plaques increasing while others decreased in the same patient. Overall, 77% vs. 51% of individual plaques progressed, while 24% vs. 49% regressed in placebo and statin, respectively (p = 0.016). Substantial increases in proximal plaques drove the progression in placebo. Statins suppressed these large increases, resulting in a 3-fold lower variance in plaque volume change compared to placebo (p = 0.025). Statins suppressed progression of fibrotic (p = 0.015) plaque, with a trend towards reducing fatty (p = 0.075) plaque and no significant effect on the calcified portion (p = 0.203).
CONCLUSION


In persons with HIV, a population with increased atherosclerosis burden and cardiovascular risk, individual coronary plaque changes vary within a given individual. Large increases in proximal plaques characterize progression, and statins act in part by stabilizing progressing plaques by reducing fatty and fibrotic plaque components, without influencing the calcified portion.",2020,"Statins suppressed progression of fibrotic (p = 0.015) plaque, with a trend towards reducing fatty (p = 0.075) plaque and no significant effect on the calcified portion (p = 0.203).
","['forty adults with HIV and subclinical coronary atherosclerosis who participated in a randomized controlled trial of', '37 patients who completed the trial, there were 92 coronary plaques']","['serial coronary computed tomography angiography', 'placebo vs. atorvastatin', 'placebo']","['serial CT angiography', 'progression of fibrotic', 'proximal plaques', 'atherosclerosis burden and cardiovascular risk, individual coronary plaque changes', 'plaque volume change', 'Individual coronary plaques']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0010054', 'cui_str': 'Coronary Atherosclerosis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",92.0,0.152296,"Statins suppressed progression of fibrotic (p = 0.015) plaque, with a trend towards reducing fatty (p = 0.075) plaque and no significant effect on the calcified portion (p = 0.203).
","[{'ForeName': 'Borek', 'Initials': 'B', 'LastName': 'Foldyna', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Clinic for Radiology, Cardiovascular Center, Bad Neustadt an der Saale, Germany. Electronic address: bfoldyna@mgh.harvard.edu.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Program in Nutritional Metabolism, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mayrhofer', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; School of Business Studies, Stralsund University of Applied Sciences, Stralsund, Germany.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Program in Nutritional Metabolism, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lu', 'Affiliation': 'Cardiovascular Imaging Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2019.08.011']
349,30900413,End-of-Trial Health Outcomes in Look AHEAD Participants who Elected to have Bariatric Surgery.,"OBJECTIVE


This study examined end-of-trial health outcomes in participants in the Action for Health in Diabetes (Look AHEAD) trial who had bariatric surgery during the approximately 10-year randomized intervention.
METHODS


Data were obtained from the Look AHEAD public access database of 4,901 individuals with type 2 diabetes and overweight/obesity who were assigned to intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) control group. Changes in outcomes in participants who had bariatric surgery were compared with those in participants with BMI ≥ 30 kg/m 2  who remained in the ILI and DSE groups.
RESULTS


A total of 99 DSE and 97 ILI participants had bariatric surgery. At randomization, these 196 participants were significantly younger and more likely to be female and to have higher BMI than the remaining ILI (N = 1,972) and DSE (N = 2,009) participants. At trial's end, surgically treated participants lost 19.3% of baseline weight, compared with 5.8% and 3.3% for the ILI and DSE groups, respectively, and were more likely to achieve partial or full remission of their diabetes.
CONCLUSIONS


The large, sustained improvements in weight and diabetes observed in this self-selected sample of surgically treated participants are consistent with results of multiple randomized trials.",2019,"At trial's end, surgically treated participants lost 19.3% of baseline weight, compared with 5.8% and 3.3% for the ILI and DSE groups, respectively, and were more likely to achieve partial or full remission of their diabetes.
","['Look AHEAD Participants who Elected to have Bariatric Surgery', 'participants in the Action for Health in Diabetes (Look AHEAD) trial who had bariatric surgery during the approximately 10-year randomized intervention', 'participants who had bariatric surgery', 'A total of 99 DSE and 97 ILI participants had bariatric surgery', '196 participants were significantly younger and more likely to be female and to have higher BMI than the remaining ILI', '4,901 individuals with type 2 diabetes and overweight/obesity who were assigned to']",['intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) control group'],"['weight and diabetes', 'partial or full remission of their diabetes']","[{'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",4901.0,0.125779,"At trial's end, surgically treated participants lost 19.3% of baseline weight, compared with 5.8% and 3.3% for the ILI and DSE groups, respectively, and were more likely to achieve partial or full remission of their diabetes.
","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Bahnson', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bantle', 'Affiliation': 'University of Minneapolis, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Health Sciences Center, University of Tennessee, Memphis, Tennessee, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Unick', 'Affiliation': 'The Miriam Hospital/Alpert Medical School at Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22411']
350,31581816,"A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial.","BACKGROUND/AIMS


Participant recruitment to diabetes prevention randomised controlled trials is challenging and expensive. The T4DM study, a multicentre, Australia-based, Phase IIIb randomised controlled trial of testosterone to prevent Type 2 diabetes in men aged 50-74 years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities. This article evaluates a high-volume, low-cost, semi-automated approach to screen and enrol T4DM study participants.
METHODS


We developed a sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening, using online data collection, computer-driven eligibility checking, and automated, email-based communication with prospective participants. Phone- and mail-based data collection and communication options were available to participants at their request. The screening process was administered by the central coordinating centre through a central data management system.
RESULTS


Screening activities required staffing of approximately 1.6 full-time equivalents over 4 years. Of 19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised. In total, 95% of the participants opted for online pre-screening over phone-based pre-screening. Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant).
CONCLUSION


A multi-step, semi-automated screening process with web-based pre-screening facilitated low-cost, high-volume participant enrolment to this large, multicentre randomised controlled trial. Centralisation and automation of screening activities resulted in substantial savings compared to previous, similar studies. Our screening approach could be adapted to other randomised controlled trial settings to minimise the cost of screening large numbers of participants.",2019,"Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant).
","['19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised', 'Type 2 diabetes in men aged 50-74\u2009years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities']","['sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening', 'testosterone']",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0445108', 'cui_str': 'Number of sites (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C2955667', 'cui_str': 'Does budget (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",[],1007.0,0.321592,"Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant).
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bracken', 'Affiliation': 'NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Allan', 'Affiliation': 'Hudson Institute of Medical Research, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Conway', 'Affiliation': 'ANZAC Research Institute, University of Sydney, Concord Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'University of Canberra, Canberra, ACT, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'The Austin Hospital and University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Handelsman', 'Affiliation': 'ANZAC Research Institute, University of Sydney, Concord Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Warrick J', 'Initials': 'WJ', 'LastName': 'Inder', 'Affiliation': 'Princess Alexandra Hospital and The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Hudson Institute of Medical Research, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stuckey', 'Affiliation': 'Keogh Institute of Medical Research and The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Bu B', 'Initials': 'BB', 'LastName': 'Yeap', 'Affiliation': 'Medical School, The University of Western Australia and Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia.""}]","Clinical trials (London, England)",['10.1177/1740774519872999']
351,31785250,Nalbuphine for Analgesia After Orthognathic Surgery and Its Effect on Postoperative Inflammatory and Oxidative Stress: A Randomized Double-Blind Controlled Trial.,"PURPOSE


Postoperative pain is a negative factor that seriously affects a surgical patient's rehabilitation. We investigated whether nalbuphine provides superior postoperative analgesia in orthognathic surgery compared with sufentanil and whether the superior analgesia is achieved by the regulation of inflammatory and oxidative stress.
PATIENTS AND METHODS


In the present randomized, double-blind, controlled clinical trial, 60 patients scheduled to undergo orthognathic surgery were randomized to receive 2.5 μg/kg of sufentanil (group S) or 2 mg/kg of nalbuphine (group N) for postoperative controlled intravenous analgesia. The primary outcome variable was the visual analog scale (VAS) score. The secondary outcome variables included the sedation score (Ramsay score) and plasma levels of inflammation factors, including tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), and oxidant stress factors, including malondialdehyde (MDA) and superoxide dismutase (SOD).
RESULTS


The VAS scores of group N were significantly lower than those of group S, and the Ramsay scores for group N were greater. The plasma levels of TNF-α, IL-6, and MDA for group N were significantly lower than those for group S, and the SOD levels were greater than those for group S. Furthermore, the VAS scores correlated positively with the plasma levels of TNF-α, IL-6, and MDA and correlated negatively with the SOD levels.
CONCLUSIONS


Nalbuphine offers better postoperative analgesia and sedation after orthognathic surgery. Nalbuphine also seems to provide superior postoperative analgesia by reducing inflammatory and oxidative stress.",2020,"The VAS scores of group N was significantly lower than those of group S, and the Ramsay scores for group N was greater.",['60 patients scheduled to undergo orthognathic surgery'],"['Nalbuphine for Analgesia', 'Nalbuphine', 'nalbuphine', 'sufentanil (group S) or 2\xa0mg/kg of nalbuphine', 'sufentanil']","['visual analog scale (VAS) score', 'Ramsay scores', 'SOD levels', 'Postoperative Inflammatory and Oxidative Stress', 'VAS scores', 'sedation score (Ramsay score) and plasma levels of inflammation factors, including tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), and oxidant stress factors, including malondialdehyde (MDA) and superoxide dismutase (SOD', 'postoperative analgesia and sedation', 'plasma levels of TNF-α, IL-6, and MDA']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}]",60.0,0.400606,"The VAS scores of group N was significantly lower than those of group S, and the Ramsay scores for group N was greater.","[{'ForeName': 'Meng Ying', 'Initials': 'MY', 'LastName': 'Xi', 'Affiliation': 'Resident, College of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Si Si', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Resident, Department of Anesthesiology, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Resident, Department of Anesthesiology, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Resident, College of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Professor, Department of Anesthesiology, Affiliated Hospital of Stomatology, Chongqing Medical University; Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences; and Chongqing Municipal Key Laboratory of Oral Biomedical Engineering of Higher Education, Chongqing, China. Electronic address: 500158@hospital.cqmu.edu.cn.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.10.017']
352,32227222,A daytime nap restores hippocampal function and improves declarative learning.,"STUDY OBJECTIVES


Daytime naps can confer benefits on subsequent declarative learning, but the physiological correlates of this improvement are less well studied. We examined learning following a daytime nap compared with an equivalent waking period using fMRI and polysomnography.
METHODS


Forty healthy young adults who slept normally the previous night encoded word pair lists in an MRI scanner at 13:00 and 16:30. Between sessions, participants either stayed awake and watched a documentary (Wake Group; N = 20) or had a 90-minute nap opportunity (Nap Group; N = 20) monitored by polysomnography. Approximately 40 minutes after completing each encoding session, memory for learned words was assessed using cued-recall.
RESULTS


A significant Session × Group interaction effect (p < 0.001) was observed in which memory was significantly improved in the Nap but not in the Wake group (p < 0.001). There was also a Session × Run × Group interaction effect in the left hippocampus (p = 0.001), whereby activation during word pair encoding increased only following the nap. Both performance improvement (rs = 0.46, p = 0.04) and nap-related increase in hippocampal activation (rs = 0.46, p = 0.04) were correlated with nap spindle count (12-15 Hz) but not with slow oscillation power (p's ≥ 0.18).
CONCLUSIONS


After a habitual nocturnal sleep, participants who had a 90-minute afternoon nap encoded word pairs better than a comparable group who stayed awake. Increases in hippocampal activation following the nap suggest restored hippocampal function. Naptime spindles may contribute to improved memory.",2020,A significant Session x Group interaction effect (p<0.001) was observed in which memory was significantly improved in the Nap but not in the Wake group (p<0.001).,['Forty healthy young adults who slept normally the previous night encoded word pair lists in an MRI scanner at 1PM and 4.30PM'],"['daytime nap compared to an equivalent waking period using fMRI and polysomnography (PSG', 'stayed awake and watched a documentary (Wake Group; N=20) or had a 90-min nap opportunity (Nap Group; N=20) monitored by PSG']","['hippocampal activation', 'nap spindle count', 'activation during word-pair encoding', 'declarative learning', 'Daytime naps']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}]",40.0,0.0374208,A significant Session x Group interaction effect (p<0.001) was observed in which memory was significantly improved in the Nap but not in the Wake group (p<0.001).,"[{'ForeName': 'Ju Lynn', 'Initials': 'JL', 'LastName': 'Ong', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Te Yang', 'Initials': 'TY', 'LastName': 'Lau', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Xuan Kai', 'Initials': 'XK', 'LastName': 'Lee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'van Rijn', 'Affiliation': 'Center for Cognitive Neuroscience, Neuroscience & Behavioral Disorders Programme, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Sleep,['10.1093/sleep/zsaa058']
353,32229771,Protein Supplementation and Resistance Training in Childhood Cancer Survivors.,"PURPOSE


Muscle weakness, low lean body mass, and poor physical performance are prevalent among adult survivors of childhood cancer (survivors). We evaluated the feasibility and effects of resistance training with and without protein supplementation on lean body mass and muscle strength among survivors.
METHODS


This double-blind placebo-controlled trial enrolled survivors ≥18 to <45 yr old. Participants were randomized to resistance training with protein supplement (21 g whey protein per day, 90 kcal) (RT + S) or resistance training with placebo (sucrose, 90 kcal) (RT + P). Participants received educational materials, access to a local fitness center, and a tailored resistance training program with tapered supervision. Participant retention and adherence were used to evaluate feasibility. Lean body mass and muscle strength were assessed at baseline and 24 wk, using dual x-ray absorptiometry, and dynamometer testing or one-repetition maximum testing, respectively. Mean changes were compared with two-way ANOVA.
RESULTS


Of 70 participants randomized, 57 completed the 24-wk intervention (24 in RT + S, 33 in RT + P). The RT + S group completed 74.8% and the RT + P group completed 67.0% of exercise sessions. Mean ± SD age for those who completed was 33.1 ± 7.0 yr, 67% were White and 47% female. There were no differences in change in lean mass (RT + S, 1.05 ± 2.34 kg; RT + P, 0.13 ± 2.19 kg; P = 0.10) or strength (grip RT + S, 1.65 ± 4.17 kg; RT + P, 1.63 ± 4.47 kg; P = 0.98; mean leg press RT + S, 58.4 ± 78.8 kg; RT + P, 51.0 ± 65.1 kg; P = 0.68) between groups. Both lean mass (P = 0.03) and strength (grip P = 0.003, leg press P < 0.001) increased over time.
CONCLUSIONS


Supervised resistance training among survivors with protein supplementation is feasible but not more effective at increasing total lean body mass than resistance training alone.",2020,"Both lean mass (p=0.03) and strength (grip p=0.003, leg press p<0.001) increased over time.
","['Childhood Cancer Survivors', 'adult survivors of childhood cancer (survivors', 'Mean age for those who completed was 33.1 years (SD 7.0), 67% were white and 47% female', 'controlled trial enrolled survivors aged ≥18 to <45 years', 'Of 70 participants randomized, 57 completed the 24-week intervention (24 in RT+S, 33 in RT+P', 'survivors']","['RT+S', 'placebo', 'Supervised resistance training', 'resistance training with protein supplement (21g whey protein/day, 90kcal) (RT+S) or resistance training with placebo (sucrose, 90kcal) (RT+P', 'Protein Supplementation and Resistance Training', 'RT+P', 'educational materials, access to a local fitness center, and a tailored resistance training program with tapered supervision', 'resistance training with and without protein supplementation']","['lean mass', 'strength (grip p=0.003, leg press p<0.001) increased over time', 'Lean body mass and muscle strength', 'lean body mass and muscle strength']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C1959943', 'cui_str': '21G (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",70.0,0.159499,"Both lean mass (p=0.03) and strength (grip p=0.003, leg press p<0.001) increased over time.
","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Krull', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Howell', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Robyn E', 'Initials': 'RE', 'LastName': 'Partin', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lanctot', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Phipps', 'Affiliation': ""Department of Psychology, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Klosky', 'Affiliation': ""Department of Pediatrics, Emory University School of Medicine, and the Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Carney', 'Affiliation': ""Department of Clinical Nutrition, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Mulrooney', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Ness', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002345']
354,31783004,"Analgesic and Anti-Inflammatory Effects of Articaine and Perineural Dexamethasone for Mandibular Third Molar Surgery: A Randomized, Double-Blind Study.","PURPOSE


We aimed to investigate the effectiveness of articaine and perineural dexamethasone (DX) in reducing postoperative sequelae such as swelling and maximum mouth opening that are harming the quality of life of patients after impacted mandibular third molar (IMTM) surgery.
PATIENTS AND METHODS


We implemented a randomized clinical trial composed of patients undergoing IMTM extraction. The predictor variable was the treatment group. The patients were randomly assigned to 1 of 3 groups: Group A was administered 3.6 mL of articaine mixed with 2 mL of saline solution; group B, 3.6 mL of articaine and 1 mL of DX (4-mg/mL solution) with 1 mL of saline solution; and group C, 3.6 mL of articaine with 2 mL of DX (8-mg/mL solution). The primary outcome variables were swelling (determined by anatomic facial landmarks), pain, and maximum mouth opening. Other variables comprised the duration of surgery, number of analgesics taken in the postoperative period, hygiene, and petechiae.
RESULTS


The sample was composed of 60 patients (20 per treatment group), with a mean age of 25.18 ± 5.22 years; 53.3% were women. Postoperative swelling was significantly reduced in groups B and C (P < .05). Maximum mouth opening was significantly increased in groups B and C (P < .05).
CONCLUSIONS


The results of this study suggest that combining DX with articaine improves the management of discomfort after IMTM surgery. The use of articaine via a mandibular block was not associated with neural damage in our study.",2020,Maximum mouth opening was significantly increased in groups B and C (P ,"['Mandibular Third Molar Surgery', '60 patients (20 per treatment group), with a mean age of 25.18\xa0±\xa05.22\xa0years; 53.3% were women', 'patients undergoing IMTM extraction', 'patients after impacted mandibular third molar (IMTM) surgery']","['articaine and 1\xa0mL of DX (4-mg/mL solution) with 1\xa0mL of saline solution', 'articaine and perineural dexamethasone (DX', 'articaine mixed with 2\xa0mL of saline solution', 'Articaine and Perineural Dexamethasone', 'articaine', 'articaine with 2\xa0mL of DX']","['Maximum mouth opening', 'swelling (determined by anatomic facial landmarks), pain, and maximum mouth opening', 'Postoperative swelling', 'duration of surgery, number of analgesics taken in the postoperative period, hygiene, and petechiae']","[{'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1720722', 'cui_str': 'Mix'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0031256', 'cui_str': 'Petechia (morphologic abnormality)'}]",60.0,0.441043,Maximum mouth opening was significantly increased in groups B and C (P ,"[{'ForeName': 'Berkem', 'Initials': 'B', 'LastName': 'Atalay', 'Affiliation': 'Assistant Professor, Vocational School of Health Sciences, İstanbul University-Cerrahpaşa, Istanbul, Turkey. Electronic address: berkematalay@gmail.com.'}, {'ForeName': 'Abdullah Tolga', 'Initials': 'AT', 'LastName': 'Şitilci', 'Affiliation': 'Assistant Professor, Department of Oral Surgery, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Özen Doğan', 'Initials': 'ÖD', 'LastName': 'Onur', 'Affiliation': 'Professor, Department of Oral Surgery, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.10.024']
355,32223724,"Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial.","Rationale:  Bronchoscopic lung volume reduction with Zephyr Valves improves lung function, exercise tolerance, and quality of life of patients with hyperinflated emphysema and little to no collateral ventilation. Objectives:   Post hoc  analysis of patient-reported outcomes (PROs), including multidimensional measures of dyspnea, activity, and quality of life, in the LIBERATE (Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema) study are reported. Methods:  A total of 190 patients with severe heterogeneous emphysema and little to no collateral ventilation in the target lobe were randomized 2:1 to the Zephyr Valve or standard of care. Changes in PROs at 12 months in the two groups were compared: dyspnea with the Transitional Dyspnea Index (TDI), focal score; the Chronic Obstructive Pulmonary Disease Assessment Test (CAT; breathlessness on hill/stairs); Borg; the EXAcerbations of Chronic pulmonary disease Tool-PRO, dyspnea domain; activity with the TDI, magnitude of task/effort/functional impairment, CAT (limited activities), and the St. George's Respiratory Questionnaire (SGRQ), activity domain; and psychosocial status with the SGRQ, impacts domain, and CAT (confidence and energy). Results:  At 12 months, patients using the Zephyr Valve achieved statistically significant and clinically meaningful improvements in the SGRQ; CAT; and the TDI, focal score, compared with standard of care. Improvements in the SGRQ were driven by the impacts and activity domains ( P  < 0.05 and  P  < 0.001, respectively). Reduction in CAT was through improvements in breathlessness ( P  < 0.05), energy level ( P  < 0.05), activities ( P  < 0.001), and increased confidence when leaving home ( P  < 0.05). The TDI measures of effort, task, and functional impairment were uniformly improved ( P  < 0.001). The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)-PRO, dyspnea domain, was significantly improved in the Zephyr Valve group. Improvements correlated with changes in residual volume and residual volume/TLC ratio. Conclusions:  Patients with severe hyperinflated emphysema achieving lung volume reductions with Zephyr Valves experience improvements in multidimensional scores for breathlessness, activity, and psychosocial parameters out to at least 12 months.Clinical trial registered with www.clinicaltrials.gov (NCT01796392).",2020,"Reduction in CAT was through improvements in breathlessness (p<0.05), energy level (p<0.05), activities (p<0.001) and increased confidence when leaving home (p<0.05).","['patients with hyperinflated emphysema and little to no collateral ventilation (CV', '190 patients with severe heterogeneous emphysema and little to no CV in the target lobe', 'Severe hyperinflated emphysema patients']","['Zephyr Valve or Standard of Care (SoC', 'Zephyr Endobronchial Valves', 'Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr® Valves']","['breathlessness (p<0.05), energy level (p<0.05), activities (p<0.001) and increased confidence', 'EXACT-PRO dyspnea domain', 'SGRQ, CAT, and TDI Focal score', 'TDI measures of effort, task, and functional impairment', 'Dyspnea: Transitional Dyspnea Index (TDI) focal score, COPD Assessment Test (CAT; breathlessness on hill/stairs), BORG, EXACT-PRO dyspnea domain; activity: TDI magnitude of task/effort/functional impairment, CAT (limited activities), SGRQ-activity domain; and psychosocial status', 'Dyspnea, Activity Levels and Quality of Life', 'multidimensional measures of dyspnea, activity, and QoL', ""St George's Respiratory Questionnaire (SGRQ) - impacts domain, CAT (confidence and energy"", 'residual volume (RV) and RV/TLC ratio.\nCONCLUSION', 'lung function, exercise tolerance and quality of life (QoL', 'multidimensional scores for breathlessness, activity and psychosocial parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C3697654', 'cui_str': 'BLVR - Bronchoscopic lung volume reduction'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0442532', 'cui_str': 'Hill (environment)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status (social concept)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",190.0,0.0340375,"Reduction in CAT was through improvements in breathlessness (p<0.05), energy level (p<0.05), activities (p<0.001) and increased confidence when leaving home (p<0.05).","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Garner', 'Affiliation': 'Royal Brompton Hospital and Imperial College, London, United Kingdom.'}, {'ForeName': 'Surya P', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Klooster', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Royal Brompton Hospital and Imperial College, London, United Kingdom.'}, {'ForeName': 'Nathaniel T', 'Initials': 'NT', 'LastName': 'Marchetti', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Sue', 'Affiliation': ""St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Wright', 'Affiliation': ""St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Hiram', 'Initials': 'H', 'LastName': 'Rivas-Perez', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Tanya A', 'Initials': 'TA', 'LastName': 'Wiese', 'Affiliation': 'Norton Healthcare, Louisville, Kentucky.'}, {'ForeName': 'Momen M', 'Initials': 'MM', 'LastName': 'Wahidi', 'Affiliation': 'Duke University Medical Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Goulart de Oliveira', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'QST Consultations Ltd., Allendale, Michigan; and.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Radhakrishnan', 'Affiliation': 'Pulmonx Corporation, Redwood City, California.'}, {'ForeName': 'Narinder S', 'Initials': 'NS', 'LastName': 'Shargill', 'Affiliation': 'Pulmonx Corporation, Redwood City, California.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201909-666OC']
356,32092608,Microbreaks in Laparoscopic Appendectomy have No Effect on Surgeons' Performance and Well-being.,"BACKGROUND


Musculoskeletal fatigue and pain as a consequence of performing surgery is found in 70%-87% of surgeons. The aim of this study was to examine the effect of microbreaks on surgeons' performance and well-being during laparoscopic appendectomy.
MATERIALS AND METHODS


The study was a blinded randomized crossover trial. Twelve surgeons were tested at three time points: Before surgery (baseline), after surgery without intervention, and after surgery where microbreaks were used every 10 min for 10 s. The musculoskeletal endurance test was used as the primary outcome. Performance was assessed by procedure length and a manual precision test. The surgeons' well-being was measured by level of exhaustion rated on the Borg CR10 scale and visual analog scale ratings for musculoskeletal discomfort in the neck, shoulders, back, wrists, and legs.
RESULTS


No significant differences were found in musculoskeletal endurance, procedure time, or the manual precision test. The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03). However, no significant difference was found between the two (P = 0.25). There was a significant increase from baseline regarding self-reported musculoskeletal discomfort in the back, shoulders, and legs after surgery but no significant differences between procedures with and without microbreaks.
CONCLUSIONS


This study did not find a positive effect of microbreaks on laparoscopic appendectomy. Exhaustion and discomfort were present after surgery, demonstrating that short surgical procedures (less than 60 min) can result in fatigue in surgeons.",2020,The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03).,[],['laparoscopic appendectomy'],"['musculoskeletal discomfort', 'level of exhaustion', 'musculoskeletal endurance, procedure time, or the manual precision test', 'Exhaustion and discomfort', 'level of exhaustion rated on the Borg CR10 scale and visual analog scale ratings for musculoskeletal discomfort in the neck, shoulders, back, wrists, and legs']",[],"[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}]","[{'cui': 'C0948594', 'cui_str': 'Musculoskeletal discomfort'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",12.0,0.198755,The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03).,"[{'ForeName': 'Laurits Schou', 'Initials': 'LS', 'LastName': 'Kromberg', 'Affiliation': 'Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark. Electronic address: laurits.s.hansen@gmail.com.'}, {'ForeName': 'Niels Vinkel', 'Initials': 'NV', 'LastName': 'Kildebro', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Laura Quitzau', 'Initials': 'LQ', 'LastName': 'Mortensen', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Ilda', 'Initials': 'I', 'LastName': 'Amirian', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.007']
357,32166864,Effect of Rifampin-Mediated OATP1B1 and OATP1B3 Transporter Inhibition on the Pharmacokinetics of the P2Y12 Receptor Antagonist Selatogrel.,"In vitro studies have indicated that the P2Y12 receptor antagonist selatogrel is a substrate of organic anion-transporting-polypeptide (OATP)1B1 and OATP1B3 that are known to mediate hepatic uptake. Selatogrel is primarily eliminated via the biliary route. Therefore, the study aim was to investigate the effect of rifampin-mediated OATP1B1 and OATP1B3 inhibition on the pharmacokinetics (PK) of selatogrel. This was a randomized, double-blind, placebo-controlled, two-period, crossover study in 14 healthy subjects. In each period, a single subcutaneous dose of 4 mg selatogrel was administered, either immediately after a single intravenous 30 minutes infusion of 600 mg rifampin or after placebo. Plasma samples were collected for 36 hours and analyzed using a validated liquid chromatography-tandem mass spectrometry method. PK parameters of selatogrel were calculated using noncompartmental analysis. The effect of rifampin was explored based on geometric mean peak plasma concentration (C max  ) and area under the concentration curve from zero to infinity (AUC 0-∞  ) ratios and for time of maximum plasma concentration (T max  ) by Wilcoxon signed rank test. In addition, the safety and tolerability of the study treatments were evaluated. The geometric mean ratios of C max  and AUC 0-∞  were 1.19 (90% confidence interval (CI) 1.11-1.28) and 1.43 (90% CI 1.36-1.51), respectively, indicating a minor selatogrel exposure increase when administered after an infusion of rifampin compared with placebo. Rifampin administration did not affect terminal half-life (t ½  ) or T max  of selatogrel. All study treatments were safe and well-tolerated. A single dose of 600 mg rifampin, a potent OATP1B1/1B3 inhibitor, did not impact the PK of selatogrel to a clinically relevant extent suggesting that OATP1B1 and OATP1B3 transporters do not play a major role in the elimination of selatogrel.",2020,Rifampin administration did not affect t ½  or t max  of selatogrel.,['14 healthy subjects'],"['rifampin or after placebo', 'placebo', 'rifampin-mediated OATP1B1 and OATP1B3 inhibition', 'rifampin', 'rifampin-mediated OATP1B1 and OATP1B3 transporter inhibition', 'Rifampin']","['safety and tolerability', 'PK parameters of selatogrel', 't ½  or t max  of selatogrel', 'geometric mean C max  and AUC 0-∞  ratios and for t max  by Wilcoxon signed rank test', 'geometric mean ratios of C max  and AUC 0-∞', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",14.0,0.41011,Rifampin administration did not affect t ½  or t max  of selatogrel.,"[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Schilling', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Voors-Pette', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Romeijn', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dogterom', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12774']
358,31311674,"Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial.","BACKGROUND


Rimegepant, a small molecule calcitonin gene-related peptide receptor antagonist, has shown efficacy in the acute treatment of migraine using a standard tablet formulation. The objective of this trial was to compare the efficacy, safety, and tolerability of a novel orally disintegrating tablet formulation of rimegepant at 75 mg with placebo in the acute treatment of migraine.
METHODS


In this double-blind, randomised, placebo-controlled, multicentre phase 3 trial, adults aged 18 years or older with history of migraine of at least 1 year were recruited to 69 study centres in the USA. Participants were randomly assigned to receive rimegepant (75 mg orally disintegrating tablet) or placebo and instructed to treat a single migraine attack of moderate or severe pain intensity. The randomisation was stratified by the use of prophylactic medication (yes or no), and was carried out using an interactive web response system that was accessed by each clinical site. All participants, investigators, and the sponsor were masked to treatment group assignment. The coprimary endpoints were freedom from pain and freedom from the most bothersome symptom at 2 h postdose. The efficacy analyses used the modified intention-to-treat population, which included all patients who were randomly assigned, had a migraine attack with pain of moderate or severe intensity, took a dose of rimegepant or placebo, and had at least one efficacy assessment after administration of the dose. The safety analyses included all randomly assigned participants who received at least one dose of study medication. This study is registered with ClinicalTrials.gov, number NCT03461757, and is closed to accrual.
FINDINGS


Between Feb 27 and Aug 28, 2018, 1811 participants were recruited and assessed for eligibility. 1466 participants were randomly assigned to the rimegepant (n=732) or placebo (n=734) groups, of whom 1375 received treatment with rimegepant (n=682) or placebo (n=693), and 1351 were evaluated for efficacy (rimegepant n=669, placebo n=682). At 2 h postdose, rimegepant orally disintegrating tablet was superior to placebo for freedom from pain (21% vs 11%, p<0·0001; risk difference 10, 95% CI 6-14) and freedom from the most bothersome symptom (35% vs 27%, p=0·0009; risk difference 8, 95% CI 3-13). The most common adverse events were nausea (rimegepant n=11 [2%]; placebo n=3 [<1%]) and urinary tract infection (rimegepant n=10 [1%]; placebo n=4 [1%]). One participant in each treatment group had a transaminase concentration of more than 3 × the upper limit of normal; neither was related to study medication, and no elevations in bilirubin greater than 2 × the upper limit of normal were reported. Treated participants reported no serious adverse events.
INTERPRETATION


In the acute treatment of migraine, a single 75 mg dose of rimegepant in an orally disintegrating tablet formulation was more effective than placebo. Tolerability was similar to placebo, with no safety concerns.
FUNDING


Biohaven Pharmaceuticals.",2019,"At 2 h postdose, rimegepant orally disintegrating tablet was superior to placebo for freedom from pain (21% vs 11%, p<0·0001; risk difference 10, 95% CI 6-14) and freedom from the most bothersome symptom (35% vs 27%, p=0·0009; risk difference 8, 95% CI 3-13).","['n=734) groups, of whom 1375 received treatment with rimegepant (n=682) or', 'Between Feb 27 and Aug 28, 2018, 1811 participants were recruited and assessed for eligibility', '1466 participants', 'migraine', 'patients who were randomly assigned, had a migraine attack with pain of moderate or severe intensity, took a dose of rimegepant or placebo, and had at least one efficacy assessment after administration of the dose', 'adults aged 18 years or older with history of migraine of at least 1 year were recruited to 69 study centres in the USA']","['rimegepant orally disintegrating tablet', 'rimegepant (75 mg orally disintegrating tablet) or placebo', 'placebo']","['serious adverse events', 'efficacy, safety, and tolerability', 'Efficacy, safety, and tolerability', 'bothersome symptom', 'freedom from pain and freedom from the most bothersome symptom at 2 h postdose', 'urinary tract infection', 'transaminase concentration', 'Tolerability', 'nausea']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",1466.0,0.722446,"At 2 h postdose, rimegepant orally disintegrating tablet was superior to placebo for freedom from pain (21% vs 11%, p<0·0001; risk difference 10, 95% CI 6-14) and freedom from the most bothersome symptom (35% vs 27%, p=0·0009; risk difference 8, 95% CI 3-13).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Croop', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA. Electronic address: robert.croop@biohavenpharma.com.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital/SLaM Biomedical Research Centre, King's College London, UK; Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stock', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Conway', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Forshaw', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Elyse G', 'Initials': 'EG', 'LastName': 'Stock', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Coric', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31606-X']
359,32128859,Randomised clinical trial: transabdominal interferential electrical stimulation vs sham stimulation in women with functional constipation.,"BACKGROUND


Managing chronic constipation is challenging as patients frequently remain dissatisfied with laxative treatments. Novel studies using transabdominal electrical interferential therapy in children have shown benefit but there are inadequate adult studies.
AIM


To examine the effects of transabdominal interferential stimulation on bowel symptoms and quality of life in women with refractory constipation.
METHODS


In a single-blind, randomised, sham-controlled pilot study, women aged ≥18 years with refractory constipation were randomised to receive interferential stimulation (with crossing of electric currents) or a novel sham stimulation (with no crossing of currents) for 1 hour a day for 6 weeks. Primary outcome was the number of patients with ≥3 spontaneous bowel movements/week. Secondary endpoints included change in PAC-SYM (Patient Assessment of Constipation-SYMptoms), PAC-QOL (Patient Assessment of Constipation-Quality of Life) and an overall symptom severity score (measured at baseline, mid time point of stimulation, end of treatment and 3 months after cessation of treatment).
RESULTS


Interferential therapy (n = 17) met the primary outcome in 9(53%) compared with 2(12%) with sham therapy (n = 16) (P = 0.02). Interferential therapy resulted in reductions in PAC-SYM (P = 0.03) and overall symptom scores (P = 0.05). Laxative use more than halved in 66% with interferential therapy compared with 14% with sham therapy (P = 0.01). Significant improvements in symptom outcomes were maintained at 3 months. There were no treatment-related adverse effects.
CONCLUSION


Transabdominal interferential electrical stimulation is effective in reducing constipation in adult women. Three months after therapy, response is maintained and quality of life improved. Not allowing currents to cross intra-abdominally was an effective placebo. (Australianclinicaltrials.gov.au ACTRN12614000736640).",2020,Interferential therapy resulted in reductions in PAC-SYM (P = 0.03) and overall symptom scores (P = 0.05).,"['women aged ≥18\xa0years with refractory constipation', 'women with functional constipation', 'women with refractory constipation', 'adult women', 'patients frequently remain dissatisfied with laxative treatments']","['transabdominal interferential stimulation', 'interferential therapy', 'interferential stimulation (with crossing of electric currents) or a novel sham stimulation (with no crossing of currents', 'placebo', 'Interferential therapy', 'transabdominal interferential electrical stimulation vs sham stimulation', 'transabdominal electrical interferential therapy', 'Transabdominal interferential electrical stimulation']","['symptom outcomes', 'number of patients with ≥3 spontaneous bowel movements/week', 'adverse effects', 'PAC-SYM', 'bowel symptoms and quality of life', 'overall symptom scores', 'change in PAC-SYM (Patient Assessment of Constipation-SYMptoms), PAC-QOL (Patient Assessment of Constipation-Quality of Life) and an overall symptom severity score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0556898', 'cui_str': 'Interferential therapy (regime/therapy)'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",66.0,0.50635,Interferential therapy resulted in reductions in PAC-SYM (P = 0.03) and overall symptom scores (P = 0.05).,"[{'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Moore', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Vic., Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Gibson', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Vic., Australia.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Burgell', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Vic., Australia.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15642']
360,32120880,Effects of an Acute Physical Activity Break on Test Anxiety and Math Test Performance.,"(1) Background: Test anxiety has been found to negatively affect students' mental health and academic performance. A primary explanation for this is that anxiety-related thoughts occupy working memory resources during testing that cannot be used for test-related processes (such as information retrieval and problem-solving). The present intervention study investigated whether physical activity could decrease anxiety levels and improve maths test performance in sixth-grade children. (2) Methods: Sixty-eight children of 11-12 years from two primary schools in New South Wales, Australia were categorised as low or high anxious from their scores on a trait-anxiety questionnaire. After this assessment, they were randomly assigned to the activity break condition, in which they had to do several physical activities of moderate intensity (i.e., star jumps) for 10 min, or the control condition, in which they played a vocabulary game for 10 min. The outcome measures were children's anxiety levels at the beginning, during, and at the end of the test, invested mental effort, perceived task difficulty and maths test performance. (3) Results: Results showed that regardless of the condition, low anxious students performed better on the maths test than high anxious children. No differences were found for any of the variables between the activity break condition and the control condition. (4) Conclusions: Although test anxiety was not reduced as expected, this study showed that short physical activity breaks can be used before examinations without impeding academic performance.",2020,No differences were found for any of the variables between the activity break condition and the control condition.,"['sixth-grade children', '2) Methods: Sixty-eight children of 11-12 years from two primary schools in New South Wales, Australia were categorised as low or high anxious from their scores on a trait-anxiety questionnaire']",['Acute Physical Activity Break'],"['invested mental effort, perceived task difficulty and maths test performance', ""children's anxiety levels"", 'anxiety levels', 'Test Anxiety and Math Test Performance']","[{'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.0273094,No differences were found for any of the variables between the activity break condition and the control condition.,"[{'ForeName': 'Myrto F', 'Initials': 'MF', 'LastName': 'Mavilidi', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ouwehand', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, 3062 PA Rotterdam, the Netherlands.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Riley', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle, Callaghan, NSW 2308, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chandler', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Keiraville, NSW 2522, Australia.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Paas', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Keiraville, NSW 2522, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17051523']
361,32227216,Topiramate reduces nocturnal eating in sleep-related eating disorder.,"STUDY OBJECTIVES


Sleep-related eating disorder (SRED) is a parasomnia characterized by partial arousals from sleep with compulsive consumption of food with impaired level of awareness and memory for the event. Small case series' have demonstrated efficacy of topiramate in SRED. We conducted a placebo-controlled randomized clinical trial of topiramate to assess efficacy in SRED.
METHODS


Thirty-four participants with an ICSD-2/ICSD-3 diagnosis of SRED with >6 months of symptoms and ≥3 sleep-related eating episodes per week were randomized to placebo or topiramate with flexible dosing to a maximum dosage of 300 mg for 13 weeks. Primary outcomes were percentage of nights with eating and Clinician Global Impression-Improvement (CGI-I). Intention-to-treat last observation carried forward (ITT LOCF) analysis was conducted.
RESULTS


Mean age was 39.5 years, 74% were female, with mean duration of sleep-related eating of 13.7 years. SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n = 15) compared to placebo (77.0% to 57.4%; n = 17) (p = 0.035). There were significantly more CGI-I responders on topiramate (71%) than placebo (27%) (p = 0.016). Level of wakefulness (r = -0.49) and memory for nighttime eating (r = -0.58) at baseline predicted topiramate response. The topiramate group lost significantly more weight than the placebo group (-8.5 lbs vs. +1.0 lbs, p = 0.001). The most common side effects were paresthesias and cognitive dysfunction.
CONCLUSIONS


This first randomized controlled trial demonstrating efficacy for treatment of SRED supports preliminary data on the use of topiramate for SRED. Side effects were prominent for topiramate. Limitations include a small sample size and a high drop-out rate in both study groups.
CLINICAL TRIAL INFORMATION


NCT00606411.",2020,SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n=15) compared to placebo (77.0% to 57.4%; n=17) (p=0.035).,"['sleep-related eating disorder', 'Sleep-Related Eating Disorder (SRED', 'Thirty-four subjects with an ICSD-2/ICSD-3 diagnosis of SRED with >6 months of symptoms and ≥3 sleep-related eating episodes per week', 'Mean age was 39.5 years, 74% were female, with mean duration of sleep-related eating of 13.7 years']","['placebo or topiramate', 'topiramate', 'Topiramate', 'placebo']","['paresthesias and cognitive dysfunction', 'percentage of nights with eating and CGI-I. Intention-to-treat last-observation-carried-forward (ITT LOCF) analysis', 'SRED symptoms', 'nocturnal eating', 'Level of wakefulness (r=-0.49) and memory for nighttime eating', 'weight', 'Side effects']","[{'cui': 'C1963717', 'cui_str': 'Sleep-related eating disorder'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",34.0,0.316903,SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n=15) compared to placebo (77.0% to 57.4%; n=17) (p=0.035).,"[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Winkelman', 'Affiliation': 'Departments of Psychiatry and Neurology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wipper', 'Affiliation': 'Departments of Psychiatry and Neurology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Purks', 'Affiliation': 'Larner College of Medicine at the University of Vermont, Burlington, VT.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Mei', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schoerning', 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA.'}]",Sleep,['10.1093/sleep/zsaa060']
362,32227220,The effects of sleep deprivation and text messaging on pedestrian safety in university students.,"STUDY OBJECTIVES


This study assesses the impact of sleep deprivation and text messaging on pedestrian injury risk.
METHODS


A total of 36 university students engaged in a virtual reality pedestrian environment in two conditions: sleep deprived (no sleep previous night) and normal sleep (normal sleep routine). Sleep was assessed using actigraphy and pedestrian behavior via four outcomes: time to initiate crossing, time before contact with oncoming vehicle, hits/close calls, and looks left/right. During each condition, participants made half the crossings while text messaging. Participants also completed the Useful Field of View test, the Psychomotor Vigilance Test, and Conners' Continuous Performance Test in both conditions.
RESULTS


While sleep deprived, students crossed significantly closer to oncoming vehicles compared with after normal sleep. While text messaging, crossed closer to vehicles and took longer to initiate crossings. Safety risks were amplified through combined sleep deprivation plus text messaging, leading to more virtual hits and close calls and shorter time before vehicle contact while crossing. Sleep-deprived students demonstrated impairments in functioning on cognitive tests.
CONCLUSIONS


University students' pedestrian behavior was generally riskier, and their cognitive functioning was impaired, when sleep deprived compared with after normal sleep. This effect was exacerbated when distracted by text messaging.",2020,"Safety risks were amplified through combined sleep deprivation plus text messaging, leading to more virtual hits and close calls and shorter time before vehicle contact while crossing.","['Thirty-six university students engaged in a', 'university students', 'University students']","['virtual reality pedestrian environment in two conditions: sleep deprived (no sleep previous night) and normal sleep (normal sleep routine', 'sleep deprivation and text messaging']","['Safety risks', 'pedestrian behavior', 'Sleep', 'actigraphy and pedestrian behavior via four outcomes: time to initiate crossing, time before contact with oncoming vehicle, hits/close calls, and looks left/right']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0450063', 'cui_str': 'Pedestrians'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0450063', 'cui_str': 'Pedestrians'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]",,0.0342278,"Safety risks were amplified through combined sleep deprivation plus text messaging, leading to more virtual hits and close calls and shorter time before vehicle contact while crossing.","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Fobian', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rouse', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Stager', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Schwebel', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Kristin T', 'Initials': 'KT', 'LastName': 'Avis', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}]",Sleep,['10.1093/sleep/zsaa057']
363,30866027,Effect of Treatment of Mild Gestational Diabetes on Long-Term Maternal Outcomes.,"OBJECTIVE


The main purpose of this article is to evaluate whether identification and treatment of women with mild gestational diabetes mellitus (GDM) during pregnancy affects subsequent maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes.
STUDY DESIGN


This is a follow-up study of women who participated in a randomized controlled treatment trial for mild GDM. Women were enrolled between 5 and 10 years after their index pregnancy. Participants underwent blood pressure, height, weight, and anthropometric measurements by trained nursing personnel using a standardized approach. A nurse-assisted questionnaire regarding screening and treatment of diabetes or hypercholesterolemia, diet, and physical activity was completed. Laboratory evaluation included fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel. Subsequent diabetes, metabolic syndrome, obesity, and adiposity in those diagnosed with mild GDM and randomized to nutritional counseling and medical therapy (treated) were compared with those who underwent routine pregnancy management (untreated). Multivariable analyses were performed adjusting for race/ethnicity and years between randomization and follow-up visit.
RESULTS


Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy. Baseline and follow-up characteristics were similar between treatment groups. Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
CONCLUSION


Identification and treatment of women with mild GDM during pregnancy had no discernible impact on subsequent diabetes, metabolic syndrome, or obesity 7 years after delivery.",2020,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","['women with mild gestational diabetes mellitus (GDM', 'Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy', 'Women were enrolled between 5 and 10 years after their index pregnancy', 'women who participated in a randomized controlled treatment trial for mild GDM']",['nutritional counseling and medical therapy (treated'],"['metabolic syndrome', 'homeostasis model assessment for insulin resistance', 'BMI', 'Frequency of diabetes', 'Subsequent diabetes, metabolic syndrome, obesity, and adiposity', 'maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes', 'fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}]",457.0,0.0436331,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': 'George Washington University Biostatistics Center, Washington, District of Columbia.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Landon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Van Dorsten', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1681058']
364,32135381,The Impact of Lactobacillus Probiotics on the Gut Microbiota in Children With Short Bowel Syndrome.,"BACKGROUND


Children with short bowel syndrome (SBS) frequently struggle with malabsorption and poor growth. The intestinal microbiota plays an important role in gut function, and children with SBS have known deficiencies in some commensal gut microbes. One strategy to enhance the gut microbiota is by taking probiotics. However, the efficacy of this approach is not well established. We hypothesized that probiotic supplementation would result in increased levels of the supplemented bacteria and improved growth.
MATERIALS AND METHODS


Children with SBS who had weaned from parenteral nutrition but with suboptimal growth were randomized to receive probiotics (Lactobacillus rhamnosus and Lactobacillus johnsonii) or placebo daily for 2 mo. The gut microbiota from monthly stool samples were compared between groups using 16S ribosomal ribonucleic acid sequencing and quantitative polymerase chain reaction. Growth between groups was also compared. Statistical analysis was completed using Mann-Whitney, Kruskal-Wallis, and chi-square tests as appropriate.
RESULTS


Eighteen children with SBS completed the study (n = 9 per group). There were no significant changes to the major bacterial families in either group. Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P = 0.161). Median z scores for weight and length did not differ between groups at the beginning or end of the study.
CONCLUSIONS


The efficacy of daily probiotic use in children with intestinal failure is unknown. In this study, Lactobacillus probiotics did not result in a predictable change to the fecal microbiota or overall growth compared with placebo in these patients.",2020,"Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P ","['Children with SBS who had weaned from parenteral nutrition but with suboptimal growth', 'children with intestinal failure', 'Children with short bowel syndrome (SBS', 'Eighteen children with SBS completed the study (n\xa0=\xa09 per group', 'Children With Short Bowel Syndrome']","['placebo', 'probiotics (Lactobacillus rhamnosus and Lactobacillus johnsonii) or placebo', 'Lactobacillus Probiotics', 'probiotic supplementation']","['fecal microbiota or overall growth', 'Median relative abundance of Lactobacillus', 'Gut Microbiota', 'levels of the supplemented bacteria and improved growth', 'Median z scores for weight and length']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0445728', 'cui_str': 'Lactobacillus johnsonii'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",18.0,0.0555,"Median relative abundance of Lactobacillus did not differ between groups at baseline or at the end of the study (7.67 versus 13.23, P = 0.523 and 1.93 versus 15.8, P ","[{'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Piper', 'Affiliation': 'Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: hannah.piper@cw.bc.ca.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Coughlin', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Van', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Channabasappa', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Andrew Y', 'Initials': 'AY', 'LastName': 'Koh', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Microbiology, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",The Journal of surgical research,['10.1016/j.jss.2020.01.024']
365,32149424,Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis.,"BACKGROUND


APT-1011, a fluticasone propionate orally disintegrating tablet formulation, is under investigation for the treatment of eosinophilic oesophagitis (EoE).
AIMS


To evaluate the safety and tolerability of APT-1011 administered to patients with EoE and to assess the effect on clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia.
METHODS


A randomised, double-blind, placebo-controlled, multicentre, phase 1b/2a study was conducted at seven medical centres in the US to evaluate the safety and tolerability of APT-1011 over 8 weeks in adults and adolescents with EoE. Participants were randomised to placebo (n = 8), 1.5 mg APT-1011 BID (n = 8) or 3.0 mg APT-1011 QD (n = 8). Safety and tolerability were assessed as the primary outcome; histologic and endoscopic measures were assessed as exploratory outcomes.
RESULTS


There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE. In one participant randomised to 1.5 mg APT-1011 BID, a reduction in cortisol was observed, but without evidence of adrenal insufficiency. Compared with placebo, treatment with APT-1011 resulted in greater reductions in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom-based EoE activity index from baseline to end of treatment (Week 8).
CONCLUSIONS


APT-1011 was safe and well tolerated in adolescents and adults with EoE. Exploratory efficacy outcomes demonstrated improvement in histologic and endoscopic findings as well evidence of symptom improvement. The results of this study support the continued development of APT-1011 for the treatment of EoE (NCT-01386112).",2020,"There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE.","['adults and adolescents with EoE. Participants', 'eosinophilic oesophagitis']","['fluticasone propionate orally disintegrating tablets versus placebo', 'mg APT-1011 QD ', 'placebo', 'fluticasone propionate', 'APT-1011', 'APT-1011 BID (n\xa0=\xa08) or 3.0']","['deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations', 'oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom-based EoE activity index', 'safety and tolerability', 'Safety and tolerability', 'safe and well tolerated', 'clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}]","[{'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003645', 'cui_str': 'APT'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}]",,0.392713,"There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE.","[{'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Department of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Safroneeva', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Roumet', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Comer', 'Affiliation': 'Adare Pharmaceuticals, Lawrenceville, NJ, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Eagle', 'Affiliation': 'Adare Pharmaceuticals, Lawrenceville, NJ, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Schoepfer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Falk', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15670']
366,32220355,"Effects of curcumin on body weight, glycemic control and serum lipids in women with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


The aim of this study was to evaluate the effect of curcumin on body weight, glycemic control and serum lipids in women suffering from polycystic ovary syndrome (PCOS).
METHODS


The current randomized, double-blinded, placebo-controlled clinical trial was performed on 60 subjects with PCOS, aged 18-40 years old. Subjects were randomly allocated to take 500 mg/day curcumin (n = 30) or placebo (n = 30) for 12 weeks. Glycemic control and serum lipids were measured at baseline and after the 12-week intervention. Using RT-PCR method, gene expression related to insulin and lipid metabolism was evaluated.
RESULTS


Curcumin significantly decreased weight (-0.8 ± 0.9 vs. -0.2 ± 0.8 kg, P = 0.03) and BMI (-0.3 ± 0.4 vs. -0.1 ± 0.3 kg/m 2 , P = 0.03). Curcumin, compared with the placebo, significantly reduced fasting glucose (β -2.63 mg/dL; 95% CI, -4.21, -1.05; P = 0.002), serum insulin (β -1.16 μIU/mL; 95% CI, -2.12, -0.19; P = 0.02), insulin resistance (β -0.26; 95% CI, -0.48, -0.03; P = 0.02), and significantly increased insulin sensitivity (β 0.006; 95% CI, 0.001, 0.01; P = 0.02). In addition, taking curcumin was associated with a significant reduction in total cholesterol (β -15.86 mg/dL; 95% CI, -24.48, -7.24; P = 0.001), LDL-cholesterol (β -16.09 mg/dL; 95% CI, -25.11, -7.06; P = 0.001) and total-/HDL-cholesterol ratio (β -0.62; 95% CI, -0.93, -0.30; P < 0.001), and a significant increase in HDL-cholesterol levels (β 2.14 mg/dL; 95% CI, 0.36, 3.92; P = 0.01) compared with the placebo. Additionally, curcumin administration up-regulated gene expression of peroxisome proliferator-activated receptor gamma (PPAR-γ) (P = 0.03) and low-density lipoprotein receptor (LDLR) (P < 0.001) compared with the placebo.
CONCLUSIONS


Overall, curcumin administration for 12 weeks to women with PCOS had beneficial effects on body weight, glycemic control, serum lipids except triglycerides and VLDL-cholesterol levels, and gene expression of PPAR-γ and LDLR. Registered under Clinical Trials.gov Identifier no. http://www.irct.ir: IRCT20170513033941N50.",2020,"Curcumin, compared with the placebo, significantly reduced fasting glucose (β -2.63 ","['women suffering from polycystic ovary syndrome (PCOS', 'women with polycystic ovary syndrome', '60 subjects with PCOS, aged 18-40 years old']","['placebo', 'curcumin']","['Glycemic control and serum lipids', 'peroxisome proliferator-activated receptor gamma (PPAR-γ', 'insulin resistance', 'reduced fasting glucose', 'LDL-cholesterol', 'HDL-cholesterol levels', 'total cholesterol', 'serum insulin', 'low-density lipoprotein receptor (LDLR', 'total-/HDL-cholesterol ratio', 'BMI', 'body weight, glycemic control, serum lipids except triglycerides and VLDL-cholesterol levels, and gene expression of PPAR-γ and LDLR', 'body weight, glycemic control and serum lipids', 'insulin sensitivity', 'weight']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0166417', 'cui_str': 'PPAR gamma'}, {'cui': 'C0166418', 'cui_str': 'Peroxisome Proliferator-Activated Receptors'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0034821', 'cui_str': 'Lipoprotein LDL Receptors'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",60.0,0.783188,"Curcumin, compared with the placebo, significantly reduced fasting glucose (β -2.63 ","[{'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Foroozanfard', 'Affiliation': 'Gametogenesis Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Kavossian', 'Affiliation': 'Gametogenesis Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Hoseini', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_r@yahoo.com.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2020.01.005']
367,32220359,Effects of a low-fat dietary regimen enriched with soy in children affected with heterozygous familial hypercholesterolemia.,"INTRODUCTION


Familial hypercholesterolemia (FH) is an inheritable, autosomal dominant disorder leading to pathologically increased levels of low-density-lipoprotein cholesterol (LDL-C). Dietary treatment remains an important tool in the management of affected children even after the decision for the initiation of pharmacotherapy is made. However, little evidence is available regarding the optimal dietary regimen for the treatment of children affected with FH.
METHODS


We present results from a randomized controlled trial in paediatric patients affected with heterozygous FH, assessing the effect of a soy-enriched fat modified diet (soy group) compared to fat modified diet (Control group) alone on LDL-C over a period of 13 weeks. Furthermore, we monitored isoflavone levels in plasma and urine as markers of adherence to the dietary treatments.
RESULTS


LDL-C decrease was statistically significantly greater in the soy group compared to the control group at week 7 (Control group 176.3 ± 27.8 mg/dl, soy group 154.7 ± 29.2 mg/dl, p = 0.038), and showed a trend towards significant at week 13 (Control group 179.9 ± 41.8 mg/dl, soy group 155.0 ± 30.2 mg/dl, p = 0.089). Relative LDL-C decrease correlated significantly with the following plasma isoflavone concentrations measured in week 7: daidzein (p < 0.004, r = 0.576) and genistein (p < 0.017, r = 0.490).
CONCLUSIONS


We provide evidence from a small randomized-controlled trial for the effectiveness and safety of a dietary treatment with soy in paediatric patients affected with heterozygous FH. The decrease in LDL-C was highly correlated with isoflavone levels, further highlighting a direct effect of soy ingestion. This study was registered under ClinicalTrials.gov Identifier No. NCT03563547.",2020,"RESULTS


LDL-C decrease was statistically significantly greater in the soy group compared to the control group at week 7 (Control group 176.3 ± 27.8 mg/dl, soy group 154.7 ± ","['paediatric patients affected with heterozygous FH', 'children affected with FH', 'children affected with heterozygous familial hypercholesterolemia']","['soy-enriched fat modified diet (soy group) compared to fat modified diet (Control group) alone on LDL-C', 'low-fat dietary regimen', 'daidzein']","['plasma isoflavone concentrations', 'LDL-C', 'LDL-C decrease']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}]","[{'cui': 'C3661828', 'cui_str': 'Increase or decrease in fat content of the diet. (Source: Academy of Nutrition and Dietetics Nutrition Informatics Committee 2013)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0057090', 'cui_str': 'diadzein'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",,0.0927128,"RESULTS


LDL-C decrease was statistically significantly greater in the soy group compared to the control group at week 7 (Control group 176.3 ± 27.8 mg/dl, soy group 154.7 ± ","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Helk', 'Affiliation': 'Division of Medicine III, Department of Nephrology and Dialysis, Medical University of Vienna, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Widhalm', 'Affiliation': 'Austrian Academic Institute for Clinical Nutrition, Austria. Electronic address: k.widhalm@gmx.at.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.09.009']
368,32220372,"Inflammatory biomarkers response to two dosages of vitamin D supplementation in patients with ulcerative colitis: A randomized, double-blind, placebo-controlled pilot study.","BACKGROUND


This study was designed to determine the effects of two dosages of vitamin D supplementation on inflammatory biomarkers in patients with ulcerative colitis (UC).
METHODS


Fifty mild to moderate active UC patients were randomly assigned to consume either 2000 or 1000 IU/day vitamin D for 12 weeks. Inflammatory biomarkers, disease activity, quality of life, anthropometric indices, dietary intakes, and physical activity were measured at the beginning and the end of the study.
RESULTS


Serum level of hs-CRP decreased in both groups at the end of study, but the changes were not significantly different within and between groups. Serum level of TNF-α in the high dose group was reduced at the end of the study non-significantly (P-value = 0.289). In the low dose group, a significant increase in serum TNF-α concentration was observed (p ≤ 0.001). The changes in serum TNF-α were significantly different between two groups (p = 0.005); however, after adjusting for the effect of confounders, the significance effect was disappeared (p = 0.162). Activity of NF-κB increased in both groups while this increase was significant in the low dose group compared to the baseline (p ≤ 0.001), and to high dose group (p = 0.006). After adjustment for confounders, the difference between groups remained statistically significant (p = 0.002).
CONCLUSION


Our results indicate that 12 weeks supplementation with 2000 IU/day vitamin D prevents from systematic inflammation, while decreasing disease activity in patients with mild to moderate active UC. Further studies are needed to find the optimum dosage and duration of supplementation. This Trial was registered at IRCT.ir with number of IRCT 20100524004010N22.",2020,"Activity of NF-κB increased in both groups while this increase was significant in the low dose group compared to the baseline (p ≤ 0.001), and to high dose group (p = 0.006).","['patients with ulcerative colitis', 'patients with ulcerative colitis (UC', 'to moderate active UC patients', 'patients with mild to moderate active UC', 'Fifty mild']","['vitamin D supplementation', 'placebo']","['Serum level of hs-CRP', 'disease activity', 'inflammatory biomarkers', 'TNF-α', 'Serum level of TNF-α', 'Activity of NF-κB', 'serum', 'changes in serum', 'Inflammatory biomarkers, disease activity, quality of life, anthropometric indices, dietary intakes, and physical activity', 'TNF-α concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.158049,"Activity of NF-κB increased in both groups while this increase was significant in the low dose group compared to the baseline (p ≤ 0.001), and to high dose group (p = 0.006).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Tabataba-Vakili', 'Affiliation': 'Department of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Ebrahimi-Daryani', 'Affiliation': 'Imam Khomeini Gastroenterology Ward School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolghader', 'Initials': 'A', 'LastName': 'Karimi', 'Affiliation': 'Department of Internal Medicine, Fayyaz Bakhsh Hospital, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: a_hekmat2000@yahoo.com.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2020.02.003']
369,31021140,An educational intervention to improve women's academic STEM outcomes: Divergent effects on well-represented vs. underrepresented minority women.,"OBJECTIVES


The aim of this field experiment was to test the effect of a social psychological intervention on an ethnically diverse sample of first-year college women majoring in science, technology, engineering, and math (STEM). We hypothesized that grade point averages in STEM courses would be higher in the intervention condition relative to the control condition. Furthermore, we tested competing hypotheses about the moderating role of belonging to either a well-represented (WR) or underrepresented minority (URM) ethnic group in STEM.
METHOD


The sample (N = 199) included 115 women from WR ethnic groups and 84 women from URM ethnic groups who were randomly assigned to condition. Women in the intervention were educated about the harmful impact of gender stereotypes in STEM and provided with effective strategies for coping with stereotype threat. At the end of their first year, we obtained participants' academic transcripts.
RESULTS


At the end of their first year in college, URM women in the intervention condition had higher grade point averages in their STEM courses than URM women in the control condition. The intervention had no effect on WR women.
CONCLUSIONS


The present research demonstrates the importance of intersectional approaches to studying the experiences of women in STEM. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Women in the intervention were educated about the harmful impact of gender stereotypes in STEM and provided with effective strategies for coping with stereotype threat.,"['ethnically diverse sample of first-year college women majoring in science, technology, engineering, and math (STEM', 'The sample (N = 199) included 115 women from WR ethnic groups and 84 women from URM ethnic groups who were randomly assigned to condition', 'underrepresented minority women']","['educational intervention', 'social psychological intervention']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0014279', 'cui_str': 'Engineerings'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",[],115.0,0.0463859,Women in the intervention were educated about the harmful impact of gender stereotypes in STEM and provided with effective strategies for coping with stereotype threat.,"[{'ForeName': 'Laurie T', 'Initials': 'LT', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychology, Tulane University.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, California State University, San Bernardino.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blodorn', 'Affiliation': 'College Transition Collaborative.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Adams', 'Affiliation': 'Department of Psychology, University of Kansas.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Hammer', 'Affiliation': 'Department of Psychology, Xavier University of Louisiana.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Gravelin', 'Affiliation': 'Department of Psychology, SUNY Geneseo.'}]",Cultural diversity & ethnic minority psychology,['10.1037/cdp0000289']
370,31519364,Pediatric empyema thoracis management: should the consensus be different for the developing countries?,"BACKGROUND


Despite the available consensus, intrapleural fibrinolytic therapy (IFT) in pediatric empyema is grossly underutilized in the Indian subcontinent where the disease burden is huge. Possible reasons may be epidemiological differences and physician bias. There is a paucity of literature from developing countries on the use of IFT in pediatric empyema thoracis. Hence, this study was undertaken to determine if fibrinolytic therapy is equivalent to video-assisted thoracoscopic surgery (VATS) in treating stage II empyema in children even in developing countries.
METHODS


Consecutive cases of stage II empyema were randomized to receive either IFT or VATS. The outcomes measured were the duration of hospital stay, efficacy of therapy, complications, and cost differences.
RESULTS


41 children were randomized to either VATS (n = 20) or IFT (n = 21) group. Overall successful clearance of empyema was achieved in 18 out of 20 (90%) children undergoing VATS and 20 out of 21(95.2%) children in fibrinolytic arm. The median length of the hospital stay was 7 and 8 days for VATS and IFT groups respectively (p = .24). Need for CT scan and blood transfusion was significantly higher in the VATS group than IFT group (p = .02 and .000).
CONCLUSIONS


Fibrinolytic therapy is noninferior to VATS in the treatment of stage II empyema in children in the Indian subcontinent. A multicenter trial with larger sample size and uniform, detailed protocols on indications for CT scan, blood transfusions, nutrition status and costs involved will be needed to eliminate institutional bias and to increase the strength of the study.
STUDY TYPE


Randomized controlled study, treatment study and cost effectiveness study.",2020,"Need for CT scan and blood transfusion was significantly higher in the VATS group than IFT group (p = .02 and .000).
","['stage II empyema in children in the Indian subcontinent', 'Consecutive cases of stage II empyema', '41 children', 'Pediatric Empyema Thoracis Management']","['intrapleural fibrinolytic therapy (IFT', 'VATS', 'fibrinolytic therapy', 'IFT', 'video-assisted thoracoscopic surgery (VATS', 'IFT or VATS', 'Fibrinolytic therapy']","['median length of the hospital stay', 'Overall successful clearance of empyema', 'CT scan and blood transfusion', 'duration of hospital stay, efficacy of therapy, complications, and cost differences']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454693', 'cui_str': 'Indian subcontinent (geographic location)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0014013', 'cui_str': 'Pyothorax'}]","[{'cui': 'C0040044', 'cui_str': 'Thrombolysis, Therapeutic'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",41.0,0.0970285,"Need for CT scan and blood transfusion was significantly higher in the VATS group than IFT group (p = .02 and .000).
","[{'ForeName': 'Gowri', 'Initials': 'G', 'LastName': 'Shankar', 'Affiliation': 'Department of Pediatric Surgery, Indira Gandhi Institute of Child Heath, Bangalore-29. Electronic address: bcgshankar@gmail.com.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Sahadev', 'Affiliation': 'Department of Pediatric Surgery, Indira Gandhi Institute of Child Heath, Bangalore-29.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Santhanakrishnan', 'Affiliation': 'Department of Pediatric Surgery, Indira Gandhi Institute of Child Heath, Bangalore-29.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.08.009']
371,32089338,Is Bilateral Mental Incisive Nerve Block Better than Unilateral Mental Incisive Nerve Block during the Endodontic Management of Mandibular Incisors with Symptomatic Irreversible Pulpitis? A Prospective Single-blind Randomized Clinical Trial.,"INTRODUCTION


The purpose of this clinical trial was to comparatively evaluate the anesthetic efficacy of unilateral and bilateral mental incisive nerve block (MINB) during the endodontic treatment of inflamed mandibular incisors.
METHODS


The study was designed as a crossover single-blind study. A total of 76 patients requiring endodontic intervention in at least 2 mandibular incisors participated in this trial. The patients randomly received unilateral or bilateral MINB of 1.8 mL of 2% lidocaine with 1:80,000 epinephrine at 2 separate appointments. To blind the procedure, a saline injection was given on the contralateral side in the unilateral injections. The endodontic procedure was initiated in the incisors on the side of the first anesthetic injection. Patients with a negative response to electric testing received endodontic access opening under rubber dam. Patients were asked to report pain, if any, during the endodontic procedure by using a Heft-Parker visual analog scale. The anesthetic success was defined as no or mild pain on Heft-Parker visual analog scale (score, 0-54). The statistical analysis was performed with McNemar tests at P values <.05.
RESULTS


The success rates of unilateral MINB and bilateral MINB were 38% and 64%, respectively, for the central incisors and 44% and 69%, respectively, for the lateral incisors. The difference was statistically significant (P < .05).
CONCLUSIONS


The bilateral MINB was more successful during the endodontic management of mandibular incisors with inflamed pulps. However, both the techniques failed to give 100% success rates.",2020,"The success rates of unilateral MINB and bilateral MINB were 38% and 64%, respectively, for the central incisors and 44% and 69%, respectively, for the lateral incisors.","['76 patients requiring endodontic intervention in at least 2 mandibular incisors participated in this trial', 'inflamed mandibular incisors']","['saline injection', 'unilateral and bilateral mental incisive nerve block (MINB', 'endodontic access opening under rubber dam', 'unilateral or bilateral MINB of 1.8\xa0mL of 2% lidocaine with 1:80,000 epinephrine', 'Unilateral Mental Incisive Nerve Block']","['anesthetic success', 'anesthetic efficacy', 'mild pain on Heft-Parker visual analog scale', 'success rates of unilateral MINB and bilateral MINB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085275', 'cui_str': 'Rubberdam'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",76.0,0.273114,"The success rates of unilateral MINB and bilateral MINB were 38% and 64%, respectively, for the central incisors and 44% and 69%, respectively, for the lateral incisors.","[{'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India. Electronic address: drvivekaggarwal@gmail.com.'}, {'ForeName': 'Satnam', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Satinder Pal', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Krishan', 'Initials': 'K', 'LastName': 'Gauba', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}]",Journal of endodontics,['10.1016/j.joen.2020.01.008']
372,32102629,Redefined Measure of Early Neurological Improvement Shows Treatment Benefit of Alteplase Over Placebo.,"Background and Purpose- The first of the 2 NINDS (National Institute of Neurological Disorders and Stroke) Study trials did not show a significant increase in early neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) improvement by ≥4, with alteplase treatment. We hypothesized that early neurological improvement defined as a percentage change in NIHSS (percent change NIHSS) at 24 hours is superior to other definitions in predicting 3-month functional outcomes and using this definition there would be treatment benefit of alteplase over placebo at 24 hours. Methods- We analyzed the NINDS rt-PA Stroke Study (Parts 1 and 2) trial data. Percent change NIHSS was defined as ([admission NIHSS score-24-hour NIHSS score]×100/admission NIHSS score] and delta NIHSS as (admission NIHSS score-24-hour NIHSS score). We compared early neurological improvement using these definitions between alteplase versus placebo patients. We also used receiver operating characteristic curve to determine the predictive association of early neurological improvement with excellent 3-month functional outcomes (Barthel Index score of 95-100 and modified Rankin Scale score of 0-1), good 3-month functional outcome (modified Rankin Scale score of 0-2), and 3-month infarct volume. Results- There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471). Receiver operating characteristic curve comparison showed that percent change NIHSS (ROC percent ) was better than delta NIHSS (ROC delta ) and admission NIHSS (ROC admission ) with regards to excellent 3-month Barthel Index (ROC percent , 0.83; ROC delta , 0.76; ROC admission , 0.75), excellent 3-month modified Rankin Scale (ROC percent , 0.83; ROC delta , 0.74; ROC admission , 0.78), and good 3-month modified Rankin Scale (ROC percent , 0.83; ROC delta , 0.76; ROC admission , 0.78). Conclusions- In the NINDS rt-PA trial, alteplase was associated with a significant percent change improvement in NIHSS at 24 hours. Percent change in NIHSS may be a better surrogate marker of thrombolytic activity and 3-month outcomes.",2020,There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471).,[],"['placebo', 'Methods', ' and Purpose', 'Placebo', 'Conclusions']","['functional outcomes (Barthel Index score of 95-100 and modified Rankin Scale score of 0-1), good 3-month functional outcome (modified Rankin Scale score of 0-2), and 3-month infarct volume', '24-hour median percent change NIHSS', 'early neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) improvement', 'excellent 3-month modified Rankin Scale', 'delta NIHSS (ROC delta ) and admission NIHSS (ROC admission ', 'good 3-month modified Rankin Scale']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.0713408,There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471).,"[{'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Scher', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lord', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frontera', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Koto', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Torres', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rostanski', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mistry', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN (E.M.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mac Grory', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Cutting', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Silver', 'Affiliation': 'Department of Neurology, University of Massachusetts Medical School, Worcester (B.S.).'}, {'ForeName': 'Ava L', 'Initials': 'AL', 'LastName': 'Liberman', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, NY (A.L.L.).'}, {'ForeName': 'Mackenzie P', 'Initials': 'MP', 'LastName': 'Lerario', 'Affiliation': 'Department of Neurology, Weill Cornell Medical College, NY (M.P.L.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Furie', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grotta', 'Affiliation': 'Department of Neurology, Memorial Hermann Hospital, Texas Medical Center, Houston (J.G.).'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, University of Cincinnati, OH (P.K.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology, Ronald Reagan UCLA Medical Center, Santa Monica, CA (J.S.).'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}]",Stroke,['10.1161/STROKEAHA.119.027476']
373,31291516,"Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine.","BACKGROUND


Calcitonin gene-related peptide receptor has been implicated in the pathogenesis of migraine. Rimegepant is an orally administered, small-molecule, calcitonin gene-related peptide receptor antagonist that may be effective in acute migraine treatment.
METHODS


In a multicenter, double-blind, phase 3 trial, we randomly assigned adults with at least a 1-year history of migraine and two to eight migraine attacks of moderate or severe intensity per month to receive rimegepant orally at a dose of 75 mg or matching placebo for the treatment of a single migraine attack. The primary end points were freedom from pain and freedom from the most bothersome symptom (other than pain) identified by the patient, both of which were assessed 2 hours after the dose of rimegepant or placebo was administered.
RESULTS


A total of 1186 patients were randomly assigned to receive rimegepant (594 patients) or placebo (592 patients); of these, 537 patients in the rimegepant group and 535 patients in the placebo group could be evaluated for efficacy. The overall mean age of the patients evaluated for efficacy was 40.6 years, and 88.7% were women. In a modified intention-to-treat analysis, the percentage of patients who were pain-free 2 hours after receiving the dose was 19.6% in the rimegepant group and 12.0% in the placebo group (absolute difference, 7.6 percentage points; 95% confidence interval [CI], 3.3 to 11.9; P<0.001). The percentage of patients who were free from their most bothersome symptom 2 hours after the dose was 37.6% in the rimegepant group and 25.2% in the placebo group (absolute difference, 12.4 percentage points; 95% CI, 6.9 to 17.9; P<0.001). The most common adverse events were nausea and urinary tract infection.
CONCLUSIONS


Treatment of a migraine attack with the oral calcitonin gene-related peptide receptor antagonist rimegepant resulted in a higher percentage of patients who were free of pain and free from their most bothersome symptom than placebo. (Funded by Biohaven Pharmaceuticals; ClinicalTrials.gov number, NCT03237845.).",2019,"The most common adverse events were nausea and urinary tract infection.
","['592 patients); of these, 537 patients in the rimegepant group and 535 patients in the', 'randomly assigned adults with at least a 1-year history of migraine and two to eight migraine attacks of moderate or severe intensity per month to receive', 'A total of 1186 patients']","['placebo', 'rimegepant orally at a dose of 75 mg or matching placebo', 'rimegepant']","['nausea and urinary tract infection', 'freedom from pain and freedom from the most bothersome symptom']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",1186.0,0.604652,"The most common adverse events were nausea and urinary tract infection.
","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Croop', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Elyse G', 'Initials': 'EG', 'LastName': 'Stock', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stock', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Morris', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Gene M', 'Initials': 'GM', 'LastName': 'Dubowchik', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Conway', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Coric', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""From the Departments of Neurology and Epidemiology and Population Health, Albert Einstein College of Medicine, and Montefiore Medical Center - both in Bronx, NY (R.B.L.); Biohaven Pharmaceuticals, New Haven, CT (R.C., E.G.S., D.A.S., B.A.M., M.F., G.M.D., C.M.C., V.C.); NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital-South London and Maudsley Biomedical Research Centre, King's College London, London (P.J.G.); and the University of California, San Francisco, San Francisco (P.J.G.).""}]",The New England journal of medicine,['10.1056/NEJMoa1811090']
374,32220636,Impact of rapid microbial identification on clinical outcomes in bloodstream infection: the RAPIDO randomized trial.,"OBJECTIVES


Bloodstream infection has a high mortality rate. It is not clear whether laboratory-based rapid identification of the organisms involved would improve outcome.
METHODS


The RAPIDO trial was an open parallel-group multicentre randomized controlled trial. We tested all positive blood cultures from hospitalized adults by conventional methods of microbial identification and those from patients randomized (1:1) to rapid diagnosis in addition to matrix-assisted desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) performed directly on positive blood cultures. The only primary outcome was 28-day mortality. Clinical advice on patient management was provided to members of both groups by infection specialists.
RESULTS


First positive blood culture samples from 8628 patients were randomized, 4312 into rapid diagnosis and 4136 into conventional diagnosis. After prespecified postrandomization exclusions, 2740 in the rapid diagnosis arm and 2810 in the conventional arm were included in the mortality analysis. There was no significant difference in 28-day survival (81.5% 2233/2740 rapid vs. 82.3% 2313/2810 conventional; hazard ratio 1.05, 95% confidence interval 0.93-1.19, p 0.42). Microbial identification was quicker in the rapid diagnosis group (median (interquartile range) 38.5 (26.7-50.3) hours after blood sampling vs. 50.3 (47.1-72.9) hours after blood sampling, p < 0.01), but times to effective antimicrobial therapy were no shorter (respectively median (interquartile range) 24 (2-78) hours vs. 13 (2-69) hours). There were no significant differences in 7-day mortality or total antibiotic consumption; times to resolution of fever, discharge from hospital or de-escalation of broad-spectrum therapy or 28-day Clostridioides difficile incidence.
CONCLUSIONS


Rapid identification of bloodstream pathogens by MALDI-TOF MS in this trial did not reduce patient mortality despite delivering laboratory data to clinicians sooner.",2020,"Microbial identification was quicker in the rapid diagnosis group (median 38·5 vs 50·3 hours after blood sampling, IQR 26·7-50·3 vs 47·1-72·9, p<0·01) but times to effective antimicrobial therapy were no shorter (median 24 hours (IQR 2-78) vs 13 hours (IQR 2-69)).","['bloodstream infection', '8,628 patients were randomised, 4,312 into rapid diagnosis, 4,136 into conventional']",['rapid microbial identification'],"['28-day survival', '7-day mortality or total antibiotic consumption; times to resolution of fever, discharge from hospital or de-escalation of broad spectrum therapy; or 28-day Clostridioides difficile incidence', 'Microbial identification', '28-day mortality']","[{'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]",8628.0,0.527018,"Microbial identification was quicker in the rapid diagnosis group (median 38·5 vs 50·3 hours after blood sampling, IQR 26·7-50·3 vs 47·1-72·9, p<0·01) but times to effective antimicrobial therapy were no shorter (median 24 hours (IQR 2-78) vs 13 hours (IQR 2-69)).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'MacGowan', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK. Electronic address: alasdair.macgowan@nbt.nhs.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grier', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stoddart', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reynolds', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Smartt', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilcox', 'Affiliation': 'Department of Microbiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Department of Clinical Microbiology, UCLH NHS Foundation Trust, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelsey', 'Affiliation': 'Department of Medical Microbiology, Whittington Hospital, Whittington NHS Trust, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Steer', 'Affiliation': 'Department of Microbiology, Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'F K', 'Initials': 'FK', 'LastName': 'Gould', 'Affiliation': 'Department of Medical Microbiology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, England, UK.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Perry', 'Affiliation': 'Department of Medical Microbiology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, England, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Howe', 'Affiliation': 'Department of Microbiology, Public Health Wales, Cardiff University Hospital of Wales, Cardiff, Wales, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Department of Microbiology, Public Health Wales, Cardiff University Hospital of Wales, Cardiff, Wales, UK.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.01.030']
375,32209122,"Challenges and practical recommendations for successfully recruiting inactive, statin-free older adults to clinical trials.","OBJECTIVES


To outline the challenges and provide practical recommendations for recruiting inactive, statin-free older adults to facilitate feasible study designs. Data was obtained from a double-blind randomised-controlled clinical trial investigating the effects of acipimox versus placebo on muscle function and metabolism in older (65-75 years), inactive, statin-free males. The initial recruitment target was 20 volunteers within 12 months (November 2016-November 2017).
RESULTS


Recruitment occurred via the Exeter 10,000 database containing 236 'eligible' males, a Facebook campaign reaching > 8000 ≥ 65 years old males, 400 directly-addressed letters to ≥ 66 year old males, > 1500 flyers distributed within the community, > 40 emails to local community groups, 4 recruitment talks, 2 magazine adverts and 1 radio advert. Widespread recruitment efforts reaching > 120,000 people led to the recruitment of 20 volunteers (18 completed the clinical trial) within a 25-month timeframe, highlighting the challenge of the timely recruitment of inactive, statin-free older adults for clinical trials. We recommend recruitment for future clinical trials should take a multi-pronged approach from the outset, prioritising the use of volunteer databases, Facebook campaigns and delivering recruitment talks.",2020,"Data was obtained from a double-blind randomised-controlled clinical trial investigating the effects of acipimox versus placebo on muscle function and metabolism in older (65-75 years), inactive, statin-free males.","[""Recruitment occurred via the Exeter 10,000 database containing 236 'eligible' males, a Facebook campaign reaching >\u20098000 ≥"", '65\xa0years old males, 400 directly-addressed letters to ≥', '20 volunteers within 12\xa0months (November 2016-November 2017', 'older (65-75\xa0years), inactive, statin-free males', '66\xa0year old males, ']",['acipimox versus placebo'],['muscle function and metabolism'],"[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3840857', 'cui_str': '8000 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}]","[{'cui': 'C0050558', 'cui_str': 'acipimox'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",20.0,0.315102,"Data was obtained from a double-blind randomised-controlled clinical trial investigating the effects of acipimox versus placebo on muscle function and metabolism in older (65-75 years), inactive, statin-free males.","[{'ForeName': 'Colleen S', 'Initials': 'CS', 'LastName': 'Deane', 'Affiliation': ""Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, St. Luke's Campus, Exeter, EX1 2LU, UK. c.s.deane@exeter.ac.uk.""}, {'ForeName': 'Bethan E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and National Institute of Health Research, Biomedical Research Centre, Division of Medicine and Graduate Entry Medicine, Royal Derby Hospital Centre, School of Medicine, University of Nottingham, Derby, DE22 3DT, UK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and National Institute of Health Research, Biomedical Research Centre, Division of Medicine and Graduate Entry Medicine, Royal Derby Hospital Centre, School of Medicine, University of Nottingham, Derby, DE22 3DT, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Steele', 'Affiliation': 'National Institute for Health Research Exeter Clinical Research Facility, Research Innovation Learning and Development Building, Royal Devon and Exeter NHS Foundation Trust, Exeter, EX2 5DW, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Libretto', 'Affiliation': 'National Institute for Health Research Exeter Clinical Research Facility, Research Innovation Learning and Development Building, Royal Devon and Exeter NHS Foundation Trust, Exeter, EX2 5DW, UK.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Statton', 'Affiliation': 'National Institute for Health Research Exeter Clinical Research Facility, Research Innovation Learning and Development Building, Royal Devon and Exeter NHS Foundation Trust, Exeter, EX2 5DW, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and National Institute of Health Research, Biomedical Research Centre, Division of Medicine and Graduate Entry Medicine, Royal Derby Hospital Centre, School of Medicine, University of Nottingham, Derby, DE22 3DT, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Etheridge', 'Affiliation': ""Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, St. Luke's Campus, Exeter, EX1 2LU, UK.""}]",BMC research notes,['10.1186/s13104-020-05017-1']
376,32219557,"Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity in Japanese subjects: results from a randomized, double-blind, placebo-controlled study (J-PURE).","BACKGROUND


Upper-limb spasticity frequently occurs after stroke and there is a clinical need for more effective therapies. The Phase III J-PURE study assessed the efficacy and safety of incobotulinumtoxinA up to 400 U for post-stroke upper-limb spasticity in Japan.
METHODS


In the 12-week main period (MP) of this double-blind, placebo-controlled study, Japanese subjects with upper-limb spasticity received one injection cycle of incobotulinumtoxinA 400 U, 250 U, or matching placebo. Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40 weeks). The primary objective was to establish the efficacy of a single incobotulinumtoxinA injection using the Modified Ashworth Scale (MAS) wrist score. Secondary efficacy outcomes and safety were also assessed.
RESULTS


Among 100 treated subjects, AUCs for incobotulinumtoxinA 400 and 250 U were significantly different versus placebo (p = 0.0014 and p = 0.0031, respectively) for change from baseline in MAS wrist score to the end of the MP, with similar results from baseline to week 4. IncobotulinumtoxinA 400 U was superior versus placebo across other spasticity patterns and at most study visits. Improvements were maintained throughout the OLEX period. Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively). IncobotulinumtoxinA was well tolerated up to 52 weeks, with no unexpected adverse events.
CONCLUSION


IncobotulinumtoxinA reduced (pathologically) increased muscle tone, improved functionality and was well tolerated in Japanese subjects with post-stroke upper-limb spasticity.",2020,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","['Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40\xa0weeks', 'Japanese subjects with post-stroke upper-limb spasticity', 'Japanese subjects', 'Japan', 'Japanese subjects with upper-limb spasticity']","['incobotulinumtoxinA', 'single incobotulinumtoxinA injection', 'placebo', 'IncobotulinumtoxinA 400 U was superior versus placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA 400 U, 250 U, or matching placebo']","['Efficacy and safety', 'efficacy and safety', 'Modified Ashworth Scale (MAS) wrist score', 'muscle tone, improved functionality and was well tolerated', 'MAS wrist score', ""Disability Assessment Scale and Investigator's Clinical Global Impression scores""]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.358522,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Masakado', 'Affiliation': 'Department of Rehabilitation Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunitsugu', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Department of Rehabilitation Medicine, Tokyo Bay Rehabilitation Hospital, Chiba, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Rehabilitation Medicine, Hospital of the University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Saitoh', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kaji', 'Affiliation': 'Department of Neurology, Tokushima University Hospital, Tokushima City, Tokushima, Japan. rkaji@tokushima-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09777-5']
377,30288843,Delayed cord clamping in term large-for-gestational age infants: A prospective randomised study.,"AIM


To compare the post-natal effects of delayed cord clamping (DCC) and early cord clamping (ECC) in term large-for-gestational age (LGA) infants.
METHODS


This prospective randomised study included 51 term LGA infants. The umbilical cords of these infants were clamped at 15 s in group 1 (ECC group (n = 26)) and at 60 s in group 2 (DCC group (n = 25)). Data for Apgar scores, cord blood, pH and lactate values, second haematocrit, 24th bilirubin levels, duration of hospital stay and admission to the neonatal intensive care unit (NICU) were recorded.
RESULTS


The demographic characteristics of the infants in the study group were not significantly different. No statistically significant difference was observed in the post-natal haematocrit and bilirubin levels between the groups. Six infants (group 1, n = 3; group 2, n = 3) were diagnosed with polycythaemia (P = 0.79); however, these infants remained asymptomatic, and no treatment was required. One infant in each group developed hyperbilirubinemia, which required phototherapy (P = 1.00). The infant with hyperbilirubinemia in the DCC group presented with asymptomatic polycythaemia. Three neonates in the DCC group required admission to the NICU for transient tachypnoea.
CONCLUSIONS


No significant increase in the rate of post-natal complications of DCC in term LGA infants was observed in the study. However, before recommending DCC on a routine basis, studies with a larger sample size and long-term follow-up are required to elucidate the risks and benefits of DCC in this group of infants.",2019,No statistically significant difference was observed in the post-natal haematocrit and bilirubin levels between the groups.,"['gestational age infants', '51 term LGA infants', 'term large-for-gestational age (LGA) infants']","['delayed cord clamping (DCC) and early cord clamping (ECC', 'Delayed cord clamping', 'DCC']","['rate of post-natal complications of DCC', 'hyperbilirubinemia', 'Apgar scores, cord blood, pH and lactate values, second haematocrit, 24th bilirubin levels, duration of hospital stay and admission to the neonatal intensive care unit (NICU', 'post-natal haematocrit and bilirubin levels']","[{'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]",51.0,0.03866,No statistically significant difference was observed in the post-natal haematocrit and bilirubin levels between the groups.,"[{'ForeName': 'Irmak', 'Initials': 'I', 'LastName': 'Vural', 'Affiliation': 'Department of Pediatrics, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Hulya', 'Initials': 'H', 'LastName': 'Ozdemir', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Gulsen', 'Initials': 'G', 'LastName': 'Teker', 'Affiliation': 'Department of Public Health, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Tevfik', 'Initials': 'T', 'LastName': 'Yoldemir', 'Affiliation': 'Department of Obstetrics and Gynecology, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Hulya', 'Initials': 'H', 'LastName': 'Bilgen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Ozek', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Marmara University Faculty of Medicine, Istanbul, Turkey.'}]",Journal of paediatrics and child health,['10.1111/jpc.14242']
378,32214294,Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain.,"BACKGROUND


Superior hypogastric plexus neurolytic (SHP-N) block is the mainstay management for pelvic cancer pain of visceral origin when oral opioids fail due to inefficacy or intolerance to side effects. Unfortunately, SHP-N has the potential to control pelvic pain in 62%-72% of patients at best, because chronic pelvic pain may assume additional characteristics other than visceral.
OBJECTIVE


Combining SHP-N with pulsed radiofrequency (PRF) of the sacral roots might block most of the pain characteristics emanating from the pelvic structures and improve the success rate of SHP-N in controlling pelvic and perineal cancer pain.
STUDY DESIGN


This study was a prospective randomized controlled clinical trial.
SETTINGS


The research took place in the interventional pain unit of a tertiary center in the university hospital.
METHODS


Fifty-eight patients complaining of cancer-related chronic pelvic and perineal pain were randomized to either the PRF + SHP group (n = 29), which received SHP-N combined with PRF of the sacral roots S2-4, or the SHP group (n = 29), which received SHP-N alone. The outcome variables were the percentage of patients who showed a > 50% reduction in their Visual Analog Scale (VAS) pain score, the VAS pain score, and global perceived effect evaluated during a 3-month follow-up period.
RESULTS


The percentage of patients who showed a > 50% reduction in their VAS pain score was significantly higher in the SHP + PRF group compared to the SHP group when assessed at one month (92.9% [n = 26] vs 57.7% [n = 15]; P = .003) and 3 months (85.7% [n = 24) vs 53.8% [n = 14]; P = .01) post procedure, respectively. However, no significant difference was observed between the 2 groups at the 6-month evaluation (SHP + PRF [57.1% (n = 16)] vs SHP [50% (n = 13)]; P = .59). There was a statistically significant reduction of VAS in the SHP + PRF group in comparison to the SHP group at one month (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.7 (95% confidence interval [CI], -1.29 to -0.1), P = .01]), 2 months (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.64 (95% CI, -1.23 to -0.05), P = .03]), and 3 months (2.7 ± 1 vs 3.4 ± 1.2 [mean difference, -0.67 (95% CI, -1.29 to -0.05)], P = .03]) post procedure, respectively; however, the 2 groups did not significantly differ at 2 weeks, 4, 5, and 6 months post procedure. Regarding postprocedural analgesic consumption, there were trends towards reduced opioid consumption at all postprocedural measured time points in the SHP+PRF group compared to the SHP group; these differences reached statistical significance at 2 months (median, 30 [interquartile range (IQR), 0.00-30] vs median, 45 [IQR, 30-90]; P = .046) and 3 months (median, 0.00 [IQR, 0.00-30] vs median, 30 [IQR, 0.00-67.5]; P = .016) post procedure, respectively.
LIMITATIONS


The study follow-up period is limited to 6 months only.
CONCLUSIONS


SHP-N combined with PRF of the sacral roots (S2, 3, 4) provided a better analgesic effect than SHP-N alone for patients with chronic pelvic and perineal pain related to pelvic cancer.
TRIAL REGISTRY


ClinicalTrials.gov. NCT03228316.
KEY WORDS


Pelvic pain, pulsed radiofrequency, sacral roots, superior hypogastric plexus.",2020,"There was a statistically significant reduction of VAS in the SHP + PRF group in comparison to the SHP group at one month (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.7 (95% confidence interval [CI], -1.29 to -0.1), P = .01]), 2 months (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.64 (95% CI, -1.23 to -0.05), P = .03]), and 3 months (2.7 ± 1 vs 3.4 ± 1.2 [mean difference, -0.67 (95% CI, -1.29 to -0.05)], P = .03]) post procedure, respectively; however, the 2 groups did not significantly differ at 2 weeks, 4, 5, and 6 months post procedure.","['Fifty-eight patients complaining of cancer-related chronic pelvic and perineal pain', 'patients with chronic pelvic and perineal pain related to pelvic cancer']","['SHP-N with pulsed radiofrequency (PRF', 'Pulsed Radiofrequency of the Sacral Roots', 'SHP', 'SHP-N combined with PRF of the sacral roots S2-4, or the SHP', 'hypogastric plexus neurolytic (SHP-N) block', 'SHP-N alone', 'SHP + PRF', 'PRF + SHP']","['analgesic effect', 'Visual Analog Scale (VAS) pain score, the VAS pain score, and global perceived effect', 'VAS pain score', 'opioid consumption', 'VAS']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0478659', 'cui_str': 'Pelvic and perineal pain (finding)'}, {'cui': 'C0751416', 'cui_str': 'Cancer of Pelvis'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0020613', 'cui_str': 'Hypogastric Plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0713119,"There was a statistically significant reduction of VAS in the SHP + PRF group in comparison to the SHP group at one month (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.7 (95% confidence interval [CI], -1.29 to -0.1), P = .01]), 2 months (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.64 (95% CI, -1.23 to -0.05), P = .03]), and 3 months (2.7 ± 1 vs 3.4 ± 1.2 [mean difference, -0.67 (95% CI, -1.29 to -0.05)], P = .03]) post procedure, respectively; however, the 2 groups did not significantly differ at 2 weeks, 4, 5, and 6 months post procedure.","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'South Egypt Cancer Institute, Assuit University, Egypt.'}, {'ForeName': 'Ashraf Amin', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': ''}, {'ForeName': 'Rania Mohammed', 'Initials': 'RM', 'LastName': 'Abdel Eman', 'Affiliation': 'South Egypt Cancer Institute, Assuit University, Assuit City, Egypt.'}, {'ForeName': 'Fatma Ahmed', 'Initials': 'FA', 'LastName': 'Abd El Aal', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Marina Emeel', 'Initials': 'ME', 'LastName': 'Helal', 'Affiliation': 'South Egypt Cancer Institute, Assuit University, Assuit City, Egypt.'}]",Pain physician,[]
379,32214295,"Comparisons of Monopolar Lesion Volumes with Hypertonic Saline Solution in Radiofrequency Ablation: A Randomized, Double-Blind, Ex Vivo Study.","BACKGROUND


Chronic degeneration of the zygapophyseal joints in the cervical or lumbar spine are common causes of axial back pain. Radiofrequency (RF) ablation is a treatment modality in the denervation of facet joint-related pain. Although multiple factors have been theorized to contribute to the size of the optimal RF lesion, the addition of hypertonic saline solution has been posited to create larger RF lesion sizes.
OBJECTIVES


This study compares lesion of 20-gauge RF monopolar probe using 2% lidocaine, 0.9% normal saline solution, and 3% saline solution administered through the RF needle prior to ablation, with subsequent lesion sizes recorded.
STUDY DESIGN


Randomized, double-blinded, ex vivo study using clinically relevant conditions.
SETTING


Procedural laboratory in an academic institution.
METHODS


RF ablation lesions were reproduced in room temperature (21°C ± 2°C) chicken breast specimens with 20-gauge monopolar RF probes inserted. RF was applied for 90 seconds at 80°C after injection of 1 mL of either 2% lidocaine, 2% lidocaine and 0.9% normal saline solution in a 1:1 ratio, or 2% lidocaine and 3% saline solution in a 1:1 ratio. Tissues were dissected, measured, and ellipsoid volumes of burn calculated. Homogeneity of variances was assessed via the Bartlett's test, and heteroskedasticity with the studentized Breusch-Pagan test. One-way analysis of variance (ANOVA) (alpha of 0.05) was used to evaluate statistical significance between volume means across groups. When the null hypothesis of no difference in burn volume between samples could not be rejected, a predefined equivalence volume of ± 0.05 cm3 was used with Welch's 2 one-sided t-tests (TOST) with a Bonferroni adjusted alpha of 0.0167 to evaluate for null acceptance.
RESULTS


The mean lesion volume for monopolar RF with 1 mL 2% lidocaine was 0.16 cm3. Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution had a mean lesion volume of 0.15 cm3, and treatment with 1 mL 2% lidocaine + 3% saline solution measured 0.17 cm3. ANOVA failed to reject the null, and TOST accepted as equivalent all 3 comparisons.
LIMITATIONS


In vivo anatomy and physiology of a human organism was not used for this study. Samples were not warmed to physiologic temperature. Randomization resulted in slightly unequal sample sizes, although all groups were of sufficient size that the central limit theorem should apply.
CONCLUSIONS


Three commonly used solutions were found to have equivalent lesion sizes from monopolar probe RF ablation.
KEY WORDS


Radiofrequency, ablation, lesion shape, lesion size, monopolar RF, hypertonic saline solution.",2020,"Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution had a mean lesion volume of 0.15 cm3, and treatment with 1 mL 2% lidocaine + 3% saline solution measured 0.17 cm3.","['Radiofrequency Ablation', 'Procedural laboratory in an academic institution']","['lidocaine, 2% lidocaine and 0.9% normal saline solution', '20-gauge RF monopolar probe using 2% lidocaine, 0.9% normal saline solution, and 3% saline solution', 'Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution', 'Hypertonic Saline Solution', 'lidocaine and 3% saline solution', 'Radiofrequency (RF) ablation', 'lidocaine']",['mean lesion volume'],"[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.447207,"Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution had a mean lesion volume of 0.15 cm3, and treatment with 1 mL 2% lidocaine + 3% saline solution measured 0.17 cm3.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Suvar', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Goree', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sanford', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Nivetha', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Heejung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}]",Pain physician,[]
380,32186967,Self-Hypnosis for Sleep Disturbances in Menopausal Women.,"Poor sleep is one of the most frequent health concerns among menopausal women. All stages of sleep can be impacted by the menopause transition. Negative outcomes of poor sleep are multidimensional and include poor physical, psychological, cognition, and social outcomes. Hypnosis is a nonpharmacological treatment for poor sleep and hot flashes in menopausal women. The goal of hypnosis is to educate and train subjects to perform self-hypnosis to alleviate the underlying symptom. The use of hypnosis as a treatment for poor sleep has shown benefits for both acute and chronic insomnia. Initial findings from the National Center for Complementary and Integrative Health (NCCIH) Hypnosis Intervention for Sleep in Menopause: Examination of Optimal Dose and Method of Delivery randomized control trial of 90 women were presented. Results showed that program and treatment satisfaction were high in all groups, adherence to daily practice met or exceeded adherence benchmarks. There were significant reduction of poor sleep quality in all groups with a significant increase in minutes slept in all groups. The majority of women also showed clinical improvements of duration. There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time. Overall, the use of self-hypnosis as a treatment program for sleep problems related to menopause was acceptable for women. Data further support that hypnosis is a promising technique to improve sleep in menopausal women with sleep and hot flashes. Further research is ongoing on self-hypnosis delivery and implementation into wider populations of women using clear definition and control groups.",2020,There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time.,"['menopausal women', 'menopausal women with sleep and hot flashes', 'Menopausal Women', '90 women were presented']","['Complementary and Integrative Health (NCCIH', 'Hypnosis', 'Hypnosis Intervention', 'Self-Hypnosis']","['perception of poor sleep quality', 'poor physical, psychological, cognition, and social outcomes', 'poor sleep quality']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",90.0,0.0167533,There were clinically meaningful improvements in reducing the perception of poor sleep quality in 50%-77% of women across time.,"[{'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Otte', 'Affiliation': 'School of Nursing, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Carpenter', 'Affiliation': 'School of Nursing, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Lynae', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'Mind-Body Medicine Research Laboratory, Department of Psychology and Neuroscience, Baylor University, Waco, Texas.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Elkins', 'Affiliation': 'Mind-Body Medicine Research Laboratory, Department of Psychology and Neuroscience, Baylor University, Waco, Texas.'}]",Journal of women's health (2002),['10.1089/jwh.2020.8327']
381,32080847,A brief diversity training: Raising awareness of ingroup privilege to improve attitudes towards disadvantaged outgroups.,"Diversity training is a popular strategy to reduce prejudice within educational settings. However, in practice, diversity training rarely relies on social-psychological theory, and research on its effectiveness in real-world settings is scarce. Previous research regarding diversity training has particularly neglected an important theoretical concept: privilege as the counterpart of discrimination. Therefore, we developed a diversity training aiming to increase awareness of ingroup privilege, using an intersectional approach to teach participants the complex interaction between privilege and oppression. We randomly allocated students of educational science (N = 112) to a repeated-measures (pre-test, post-test, follow-up) control-group design. Compared with the control group, training participants showed a significant increase in awareness of ingroup privilege 1 week after the training, whereas there was no change in awareness of discrimination. Furthermore, increased awareness of ingroup privilege 1 week after the training mediated improved outgroup attitudes (i.e., more positive outgroup feelings towards immigrants and refugees, reduced subtle prejudice towards immigrants and reduced homonegativity) 2 weeks after the training.",2020,"Compared with the control group, training participants showed a significant increase in awareness of ingroup privilege 1 week after the training, whereas there was no change in awareness of discrimination.",[],"['educational science (N\xa0=\u2009112) to a repeated-measures (pre-test, post-test, follow-up) control-group design', 'Diversity training']","['awareness of ingroup privilege', 'outgroup attitudes', 'awareness of discrimination']",[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}]",,0.014682,"Compared with the control group, training participants showed a significant increase in awareness of ingroup privilege 1 week after the training, whereas there was no change in awareness of discrimination.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Ehrke', 'Affiliation': 'University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Aysan', 'Initials': 'A', 'LastName': 'Ashoee', 'Affiliation': 'University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Melanie C', 'Initials': 'MC', 'LastName': 'Steffens', 'Affiliation': 'University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Louvet', 'Affiliation': 'University of Strasbourg, Strasbourg, France.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12665']
382,31633643,Improved Reduction of the Tibiofibular Syndesmosis With TightRope Compared With Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction after high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device.
DESIGN


Prospective randomized controlled multicenter trial.
SETTING


Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada.
PATIENTS/PARTICIPANTS


One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either TightRope (1 knotless TightRope, group T) or screw fixation (two 3.5-mm cortical positional screws placed across 3 cortices, group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the TightRope device. Follow-up was performed at 2 and 6 weeks, 3, 6, and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle computed tomography scan results at 3 months after fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud-Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire. The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39% compared with 15% using TightRope fixation (P = 0.028, χ). Analysis of computed tomography results was performed using a 2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular). Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05). Group T syndesmoses also had greater diastasis compared with control limb (4.1 ± 1.3 vs. 3.3 ± 1.4 mm, P < 0.01) and less fibular medialization compared with group S (1.04 ± 1.8 vs. 0.3 ± 1.8 mm, P = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. Foot and Ankle Disability Index scores at each time interval were 44 ± 22 (T) versus 45 ± 24 (S) (6 weeks), 76 ± 14 versus 73 ± 17 (3 months), 89 ± 10 versus 86 ± 13 (6 months), and 93 ± 9 versus 90 ± 14 (12 months) (all P > 0.2). The reoperation rate was higher in the screw group compared with TightRope (30% vs. 4%, P = 0.02) with the difference driven by the rate of implant removal.
CONCLUSIONS


Based on our results, the TightRope device seems to compare favorably with two, 3.5-mm, 3-cortex screw fixation for syndesmosis injuries.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05).","['Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada', 'One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment']","['TightRope (1 knotless TightRope, group T) or screw fixation', 'Screw Fixation', '3-cortex screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device', 'TightRope']","['rate of implant removal', 'Foot and Ankle Disability Index scores', '2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular', 'greater anterior translation', 'adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud-Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire', 'reoperation rate', 'fibular medialization', 'rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle computed tomography scan results']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",240.0,0.152368,"Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Department of Orthopedic Surgery, Foothills Medical Centre, Calgary, AB, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
383,31634286,Early Effects of the Trauma Collaborative Care Intervention: Results From a Prospective Multicenter Cluster Clinical Trial.,"OBJECTIVES


To evaluate the impact of the Trauma Collaborative Care (TCC) program's early intervention components on 6-week outcomes. TCC was developed to improve psychosocial sequelae of orthopaedic trauma and includes the Trauma Survivors Network and additional collaborative care services.
DESIGN


Prospective, multicenter, cluster clinical trial.
SETTING


Level I Trauma Centers.
PATIENTS


Individuals with high-energy orthopaedic injuries requiring surgery and hospital admission: 413 patients at 6 trauma centers implementing the TCC program and 374 patients at 6 trauma centers receiving usual care.
INTERVENTION


TCC early intervention: patient education, peer visits, and coaching calls.
MAIN OUTCOME MEASUREMENTS


Pain rating scale, Patient Health Questionnaire-9 depression, Post-Traumatic Stress Disorder Checklist, and self-efficacy for return to work and managing finances. For each outcome, a hybrid Bayesian statistical procedure, accounting for clustering within sites and differences in baseline characteristics between sites, was used to estimate the intention-to-treat (ITT) effect and the effect under full receipt of early intervention components.
RESULTS


Sites varied substantially in utilization of intervention components. The posterior estimates of the ITT (full receipt) effect favor TCC for 4 (5) of the 5 endpoints. The posterior probabilities of a favorable (ITT; full receipt) TCC effect were as follows: depression (89%-93%), pain (84%-74%), post-traumatic stress disorder (68%-68%), self-efficacy for return to work (74%-76%), and self-efficacy for managing finances (47%-61%).
CONCLUSIONS


Results suggest TCC may have a small positive effect on early outcomes, but use of the services was highly variable among sites.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,The posterior estimates of the ITT (full receipt) effect favor TCC for 4 (5) of the 5 endpoints.,"['Level I Trauma Centers', 'Individuals with high-energy orthopaedic injuries requiring surgery and hospital admission: 413 patients at 6 trauma centers implementing the TCC program and 374 patients at 6 trauma centers receiving usual care']","['TCC', 'Trauma Collaborative Care (TCC', 'Trauma Collaborative Care Intervention', 'TCC early intervention: patient education, peer visits, and coaching calls']","['TCC effect', 'posterior probabilities of a favorable (ITT; full receipt', 'psychosocial sequelae of orthopaedic trauma', 'intention-to-treat (ITT) effect', 'depression', 'Pain rating scale, Patient Health Questionnaire-9 depression, Post-Traumatic Stress Disorder Checklist, and self-efficacy for return to work and managing finances', 'pain', 'post-traumatic stress disorder', 'self-efficacy']","[{'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0376243', 'cui_str': 'finances'}]",413.0,0.137861,The posterior estimates of the ITT (full receipt) effect favor TCC for 4 (5) of the 5 endpoints.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001581']
384,31885286,Islet Harvest in Carbon Monoxide-Saturated Medium for Chronic Pancreatitis Patients Undergoing Islet Autotransplantation.,"Stresses encountered during human islet isolation lead to unavoidable β-cell death after transplantation. This reduces the chance of insulin independence in chronic pancreatitis patients undergoing total pancreatectomy and islet autotransplantation. We tested whether harvesting islets in carbon monoxide-saturated solutions is safe and can enhance islet survival and insulin independence after total pancreatectomy and islet autotransplantation. Chronic pancreatitis patients who consented to the study were randomized into carbon monoxide (islets harvested in a carbon monoxide-saturated medium) or control (islets harvested in a normal medium) groups. Islet yield, viability, oxygen consumption rate, β-cell death (measured by unmethylated insulin DNA), and serum cytokine levels were measured during the peri-transplantation period. Adverse events, metabolic phenotypes, and islet function were measured prior and at 6 months post-transplantation. No adverse events directly related to the infusion of carbon monoxide islets were observed. Carbon monoxide islets showed significantly higher viability before transplantation. Subjects receiving carbon monoxide islets had less β-cell death, decreased CCL23, and increased CXCL12 levels at 1 or 3 days post transplantation compared with controls. Three in 10 (30%) of the carbon monoxide subjects and none of the control subjects were insulin independent. This pilot trial showed for the first time that harvesting human islets in carbon monoxide-saturated solutions is safe for total pancreatectomy and islet autotransplantation patients.",2019,"Subjects receiving carbon monoxide islets had less β-cell death, decreased CCL23, and increased CXCL12 levels at 1 or 3 days post transplantation compared with controls.","['Chronic pancreatitis patients who consented to the study were randomized into', 'Chronic Pancreatitis Patients Undergoing Islet Autotransplantation', 'total pancreatectomy and islet autotransplantation patients', 'chronic pancreatitis patients undergoing total pancreatectomy and islet autotransplantation']","['carbon monoxide (islets harvested in a carbon monoxide-saturated medium) or control (islets harvested in a normal medium', 'Carbon monoxide islets', 'carbon monoxide islets', 'Islet Harvest in Carbon Monoxide-Saturated Medium', 'harvesting islets in carbon monoxide-saturated solutions', 'carbon monoxide-saturated solutions']","['carbon monoxide islets', 'β-cell death, decreased CCL23, and increased CXCL12 levels', 'Islet yield, viability, oxygen consumption rate, β-cell death (measured by unmethylated insulin DNA), and serum cytokine levels', 'Adverse events, metabolic phenotypes, and islet function']","[{'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy (procedure)'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0522534', 'cui_str': 'Saturated (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0326605,"Subjects receiving carbon monoxide islets had less β-cell death, decreased CCL23, and increased CXCL12 levels at 1 or 3 days post transplantation compared with controls.","[{'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Gou', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Strange', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Cloud', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Owzarski', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Shuford', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Duke', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Luttrell', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lesher', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Klearchos K', 'Initials': 'KK', 'LastName': 'Papas', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Department of Immunology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Clark', 'Affiliation': 'Department of Immunology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Usmani-Brown', 'Affiliation': 'Department of Immunology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kitzmann', 'Affiliation': 'Department of Surgery, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Crosson', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Adams', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Morgan', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, SC, USA.'}]",Cell transplantation,['10.1177/0963689719890596']
385,31900204,Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial.,"The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.",2020,"The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial.","['hospitalized patients with laboratory-confirmed MERS', 'Middle East respiratory syndrome with a combination of']","['placebo', 'lopinavir/ritonavir and recombinant interferon-β1b', 'Lopinavir/ritonavir and intErferon-β1b', 'lopinavir/ritonavir and interferon-β1b']",['90-day mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3694279', 'cui_str': 'Middle East Respiratory Syndrome'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0939237', 'cui_str': 'lopinavir / Ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.496389,"The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial.","[{'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. arabi@ngha.med.sa.'}, {'ForeName': 'Ayed Y', 'Initials': 'AY', 'LastName': 'Asiri', 'Affiliation': 'Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Assiri', 'Affiliation': 'Infection Prevention and Control, Assistant Deputy Minister, Preventive Health, Ministry of Health, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hani A', 'Initials': 'HA', 'LastName': 'Aziz Jokhdar', 'Affiliation': 'Deputy Minister for Public Health, Ministry of Health, Riyadh, Saudi Arabia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alothman', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hanan H', 'Initials': 'HH', 'LastName': 'Balkhy', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'AlJohani', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Shmeylan', 'Initials': 'S', 'LastName': 'Al Harbi', 'Affiliation': 'College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Suleiman', 'Initials': 'S', 'LastName': 'Kojan', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Al Jeraisy', 'Affiliation': 'College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Deeb', 'Affiliation': 'King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Memish', 'Affiliation': 'Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameeh', 'Initials': 'S', 'LastName': 'Ghazal', 'Affiliation': 'Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Al Faraj', 'Affiliation': 'Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Hameed', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'AlSaedi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mandourah', 'Affiliation': 'Military Medical Services, Ministry of Defense, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ghaleb A', 'Initials': 'GA', 'LastName': 'Al Mekhlafi', 'Affiliation': 'Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nisreen Murad', 'Initials': 'NM', 'LastName': 'Sherbeeni', 'Affiliation': 'Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fatehi Elnour', 'Initials': 'FE', 'LastName': 'Elzein', 'Affiliation': 'Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Almotairi', 'Affiliation': 'Department of Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Bshabshe', 'Affiliation': 'Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Kharaba', 'Affiliation': 'Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia.'}, {'ForeName': 'Jesna', 'Initials': 'J', 'LastName': 'Jose', 'Affiliation': 'Department Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Al Harthy', 'Affiliation': 'Intensive Care Unit, King Saud Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al Sulaiman', 'Affiliation': 'Infectious Disease, King Saud Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mady', 'Affiliation': 'Intensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville, Virginia, USA.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Al-Dawood', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelzaher', 'Affiliation': 'Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah, Saudi Arabia.'}, {'ForeName': 'Wail', 'Initials': 'W', 'LastName': 'Bajhmom', 'Affiliation': 'Internal Medicine Department, King Fahad General Hospital, Ministry of Health, Jeddah, Saudi Arabia.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3846-x']
386,32191506,Comparing the Efficacy of a Compound Topical Anesthetic Versus Benzocaine: A Pilot Study.,"To compare the effectiveness of a combination of 10% lidocaine, 10% prilocaine, and 4% tetracaine versus 20% benzocaine for use as a topical anesthetic agent prior to dental injections. A double-blind randomized prospective clinical trial was conducted with 26 participants receiving a topical anesthetic of 20% benzocaine (control) and 26 participants receiving a compound topical anesthetic mixture of 10% lidocaine, 10% prilocaine, and 4% tetracaine (experimental) prior to a maxillary infiltration injection. The procedure was conducted by 1 operator with the Wand ®  injection system. Pain was assessed directly with visual analog scale (VAS) scores and indirectly by measuring changes in heart rate at 4 different time points. Complications associated with the application of the topical anesthetics were also assessed. The experimental group had a significantly higher mean VAS score of 19.5 ± 19.7 mm versus 14.2 ± 14.6 mm for the control group ( p  < .001). No significant differences in heart rate at any of the 4 measured time points compared with baseline were noted for either group. The experimental group had a significantly higher incidence of complications, including tissue sloughing, when compared with the control group ( p  < .001). Participants in the control group reported significantly lower VAS scores than those in the experimental group. Both types of topical anesthetic showed similar impacts on alterations to heart rate. No benefits were seen with the use of 10% lidocaine, 10% prilocaine, and 4% tetracaine as a topical anesthetic prior to a maxillary infiltration of local anesthetic when compared with 20% benzocaine.",2020,"The experimental group had a significantly higher incidence of complications, including tissue sloughing, when compared with the control group ( p  < .001).",['26 participants receiving a topical anesthetic of 20% benzocaine (control) and 26 participants receiving a'],"['lidocaine, 10% prilocaine, and 4% tetracaine versus 20% benzocaine', 'Compound Topical Anesthetic Versus Benzocaine', 'tetracaine', 'lidocaine', 'compound topical anesthetic mixture of 10% lidocaine, 10% prilocaine, and 4% tetracaine (experimental) prior to a maxillary infiltration injection', 'prilocaine']","['alterations to heart rate', 'VAS scores', 'Pain', 'mean VAS score', 'incidence of complications, including tissue sloughing', 'heart rate', 'visual analog scale (VAS) scores and indirectly by measuring changes in heart rate']","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic (substance)'}, {'cui': 'C0005059', 'cui_str': 'Benzocaine'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0039629', 'cui_str': 'Tetracaine'}, {'cui': 'C0005059', 'cui_str': 'Benzocaine'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic (substance)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",26.0,0.0846109,"The experimental group had a significantly higher incidence of complications, including tissue sloughing, when compared with the control group ( p  < .001).","[{'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tom', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bui', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tanbonliong', 'Affiliation': 'Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, California.'}]",Anesthesia progress,['10.2344/anpr-66-03-05']
387,31047017,Natriuretic Response Is Highly Variable and Associated With 6-Month Survival: Insights From the ROSE-AHF Trial.,"OBJECTIVES


This study sought to describe sodium excretion in acute decompensated heart failure (ADHF) clearly and to evaluate the prognostic ability of urinary sodium and fluid-based metrics.
BACKGROUND


Sodium retention drives volume overload, with fluid retention largely a passive, secondary phenomenon. However, parameters (urine output, body weight) used to monitor therapy in ADHF measure fluid rather than sodium balance. Thus, the accuracy of fluid-based metrics hinges on the contested assumption that urinary sodium content is consistent.
METHODS


Patients enrolled in the ROSE-AHF (Renal Optimization Strategies Evaluation-Acute Heart Failure) trial with 24-h sodium excretion available were studied (n = 316). Patients received protocol-driven high-dose loop diuretic therapy.
RESULTS


Sodium excretion through the first 24 h was highly variable (range 0.12 to 19.8 g; median 3.63 g, interquartile range: 1.85 to 6.02 g) and was not correlated with diuretic agent dose (r = 0.06; p = 0.27). Greater sodium excretion was associated with reduced mortality in a univariate model (hazard ratio: 0.80 per doubling of sodium excretion; 95% confidence interval: 0.66 to 0.95; p = 0.01), whereas gross urine output (p = 0.43), net fluid balance (p = 0.87), and weight change (p = 0.11) were not. Sodium excretion of less than the prescribed dietary sodium intake (2 g), even in the setting of a negative net fluid balance, portended a worse prognosis (hazard ratio: 2.02; 95% confidence interval: 1.17 to 3.46; p = 0.01).
CONCLUSIONS


In patients hospitalized with ADHF who were receiving high-dose loop diuretic agents, sodium concentration and excretion were highly variable. Sodium excretion was strongly associated with 6-month mortality, whereas traditional fluid-based metrics were not. Poor sodium excretion, even in the context of fluid loss, portends a worse prognosis.",2019,"Greater sodium excretion was associated with reduced mortality in a univariate model (hazard ratio: 0.80 per doubling of sodium excretion; 95% confidence interval: 0.66 to 0.95; p = 0.01), whereas gross urine output (p = 0.43), net fluid balance (p = 0.87), and weight change (p = 0.11) were not.","['acute decompensated heart failure (ADHF', 'Patients enrolled in the ROSE-AHF (Renal Optimization Strategies Evaluation-Acute Heart Failure) trial with 24-h sodium excretion available were studied (n\xa0= 316', 'patients hospitalized with ADHF']",['protocol-driven high-dose loop diuretic therapy'],"['6-month mortality', 'net fluid balance', 'Natriuretic Response', 'gross urine output', 'Greater sodium excretion', 'Sodium excretion', 'weight change']","[{'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450356', 'cui_str': '316'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0354100', 'cui_str': 'Loop Diuretics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",316.0,0.0919205,"Greater sodium excretion was associated with reduced mortality in a univariate model (hazard ratio: 0.80 per doubling of sodium excretion; 95% confidence interval: 0.66 to 0.95; p = 0.01), whereas gross urine output (p = 0.43), net fluid balance (p = 0.87), and weight change (p = 0.11) were not.","[{'ForeName': 'Daniel Z', 'Initials': 'DZ', 'LastName': 'Hodson', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Parinita', 'Initials': 'P', 'LastName': 'Raghavendra', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'F Perry', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Veena S', 'Initials': 'VS', 'LastName': 'Rao', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost Limburg, Genk-Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University Diepenbeek, Belgium.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: jeffrey.testani@yale.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.01.007']
388,32217051,Optimising subjective anterior eye grading precision.,"PURPOSE


To establish the optimum grading increment which ensured parity between practitioners while maximising clinical precision.
METHODS


Second year optometry students (n = 127, 19.5 ± 1.4 years, 55 % female) and qualified eye care practitioners (n = 61, 40.2 ± 14.8 years, 52 % female) had 30 s to grade each of bulbar, limbal and palpebral hyperaemia of the upper lid of 4 patients imaged live with a digital slit lamp under 16× magnification, diffuse illumination, with the image projected on a screen. The patients were presented in a randomised sequence 3 times in succession, during which the graders used the Efron printed grading scale once to the nearest 0.1 increment, once to nearest 0.5 increment and once to the nearest integer grade in a randomised order. Graders were masked to their previous responses.
RESULTS


For most grading conditions less than 20 % of clinicians showed a ≤0.1 difference in grade from the mean. In contrast, more than 50 % of the student graders and 40 % of experienced graders showed a difference in grade from the mean within 0.5 for all conditions under measurement. Student precision in grading was better with both 0.1 and 0.5 grading increments than grading to the nearest unit, except for limbal hyperaemia where they performed more accurately with 0.5 unit increment grading. Limbal grading precision was not affected by grading step increment for experienced practitioners, but 0.1 and 0.5 grading increments were both better than the 1.0 grading increment for bulbar hyperaemia and the 0.1 grading increment was better than the 0.5 grading increment and both were better than the 1.0 grading increment for palpebral hyperaemia.
CONCLUSION


Although narrower interval scales maximise the ability to detect smaller clinical changes, the grading increment should not exceed one standard deviation of the discrepancy between measurements. Therefore, 0.5 grading increments are recommended for subjective anterior eye physiology grading (limbal, bulbar and palpebral redness).",2020,"Limbal grading precision was not affected by grading step increment for experienced practitioners, but 0.1 and 0.5 grading increments were both better than the 1.0 grading increment for bulbar hyperaemia and the 0.1 grading increment was better than the 0.5 grading increment and both were better than the 1.0 grading increment for palpebral hyperaemia.
","['Second year optometry students (n\u2009=\u2009127, 19.5\u2009±\u20091.4 years, 55 % female) and qualified eye care practitioners (n\u2009=\u200961, 40.2\u2009±\u200914.8 years, 52 % female) had 30\u2009s to grade each of bulbar, limbal and palpebral hyperaemia of the upper lid of 4 patients imaged live with a digital slit lamp under 16× magnification, diffuse illumination, with the image projected on a screen']",[],"['limbal hyperaemia', 'Limbal grading precision', 'subjective anterior eye physiology grading (limbal, bulbar and palpebral redness', 'bulbar hyperaemia', 'palpebral hyperaemia']","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029147', 'cui_str': 'Optometry'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0183355', 'cui_str': ""Gullstrand's Slit Lamp""}, {'cui': 'C1444591', 'cui_str': 'Diffuse illumination'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",[],"[{'cui': 'C0423193', 'cui_str': 'Limbal injection (finding)'}, {'cui': 'C0443251', 'cui_str': 'Limbal (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0028853', 'cui_str': 'Visual Physiology'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}]",,0.0273566,"Limbal grading precision was not affected by grading step increment for experienced practitioners, but 0.1 and 0.5 grading increments were both better than the 1.0 grading increment for bulbar hyperaemia and the 0.1 grading increment was better than the 0.5 grading increment and both were better than the 1.0 grading increment for palpebral hyperaemia.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vianya-Estopa', 'Affiliation': 'Vision and Hearing Sciences, Anglia Ruskin University, Cambridge, UK. Electronic address: marta.vianya@anglia.ac.uk.'}, {'ForeName': 'Manbir', 'Initials': 'M', 'LastName': 'Nagra', 'Affiliation': 'Optometry, University of Portsmouth, Portsmouth, UK. Electronic address: manbir.nagra@port.ac.uk.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'School of Biomedical Sciences, Ulster University, Coleraine, UK. Electronic address: ajs.cochrane@ulster.ac.uk.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Retallic', 'Affiliation': 'Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. Electronic address: optomneil@outlook.com.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Dunning', 'Affiliation': 'Advanced Technology Centre, Bradford College, Bradford, UK. Electronic address: D.Dunning@bradfordcollege.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Terry', 'Affiliation': 'School of Optometry and Vision Sciences, Cardiff University, Cardiff, UK. Electronic address: TerryL1@cardiff.ac.uk.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Lloyd', 'Affiliation': 'School of Physics & Clinical & Optometric Sciences, Technological University Dublin, Ireland. Electronic address: aoife.lloydmckernan@dit.ie.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, UK. Electronic address: j.s.w.wolffsohn@aston.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.03.006']
389,31397718,Maternal HIV does not affect resiliency among uninfected/HIV exposed South African children from birth to 5 years of age.,"OBJECTIVE


Examine resiliency among a South African population cohort of children of mothers living with HIV (MLH) and mothers without HIV (MWOH) in low-income townships over the first 5 years of life.
DESIGN


A cluster randomized controlled intervention trial evaluating child resiliency and the effects of home visiting in township neighborhoods from pregnancy through 5 years postbirth.
METHODS


The population of pregnant women in 24 matched neighborhoods were recruited and randomized by neighborhood to a standard care condition (n = 594) or a paraprofessional home visiting intervention condition (n = 644). Mothers and children were assessed at 2 weeks, 6, 18, 36, and 60 months postbirth (92-84% follow-up; 10.2% mortality). Resilient children were identified based on consistently meeting global standards for growth, cognitive functioning, and behavior. Maternal HIV status (n = 354 MLH; n = 723 mothers without HIV MWOH), intervention condition, maternal risks, caretaking, sociodemographic characteristics, and neighborhood were examined as predictors of child resiliency over time using analysis of variance, chi-square analyses, and Fisher's exact tests, where appropriate.
RESULTS


None of HIV-seropositive children (n = 17) were resilient; 19% of 345 HIV-exposed but uninfected children of MLH were resilient, a rate very similar to the 16% among MWOH. Resiliency was significantly associated with lower income, food security, not having a live-in partner, and the absence of maternal risk (i.e., not being depressed, using alcohol, or being a victim of intimate partner violence). Being randomized to a home visiting intervention, maternal breastfeeding for at least 3 months and attending a preschool crèche were also unrelated to resiliency. Although matched pairs of neighborhoods had similar rates of resilient children, resiliency varied significantly by neighborhood with rates ranging from 9.5 to 27%.
CONCLUSION


We set a new standard to define resiliency, as consistently recommended by theoreticians. Although seropositive children are not resilient, uninfected children of MLH are as resilient as their peers of MWOH. Typical protective factors (e.g., home visiting, breastfeeding, preschool) were unrelated to resiliency over the first 5 years of life.
TRIAL REGISTRATION


ClinicalTrials.gov registration #NCT00996528.",2019,"Resiliency was significantly associated with lower income, food security, not having a live-in partner, and the absence of maternal risk (i.e., not being depressed, using alcohol, or being a victim of intimate partner violence).","['population of pregnant women in 24 matched neighborhoods', 'township neighborhoods from pregnancy through 5 years postbirth', 'South African population cohort of children of mothers living with HIV (MLH) and mothers without HIV (MWOH) in low-income townships over the first 5 years of life']","['neighborhood to a standard care condition (n\u200a=\u200a594) or a paraprofessional home visiting intervention condition', 'home visiting intervention, maternal breastfeeding']","['Maternal HIV status', 'lower income, food security, not having a live-in partner, and the absence of maternal risk']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",723.0,0.050929,"Resiliency was significantly associated with lower income, food security, not having a live-in partner, and the absence of maternal risk (i.e., not being depressed, using alcohol, or being a victim of intimate partner violence).","[{'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Christodoulou', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Panteha', 'Initials': 'P', 'LastName': 'Hayati Rezvan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California, Los Angeles, California, USA.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Comulada', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Skeen', 'Affiliation': 'Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Almirol', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002176']
390,32209015,Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study.,"The quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) was assessed as a booster in this Phase III trial (NCT02752906). Quadrivalent meningococcal conjugate vaccine (MCV4)-primed individuals aged ≥15 y (n = 810) were randomized 1:1 to receive a single booster dose of MenACYW-TT (n = 403) or a licensed MCV4 (Menactra®; MCV4-DT [n = 407]). Serum bactericidal antibody assay with human complement (hSBA) was used to measure functional antibodies against serogroups A, C, W, and Y at baseline and Day 30 post-vaccination. Proportions of participants achieving seroresponse (post-vaccination titer ≥1:16 for those with baseline titer <1:8 or ≥4-fold increase in post-vaccination titer for those with baseline titer ≥1:8) were determined. Safety data were collected for 180 d post-vaccination. Non-inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30. Moreover, ≥99% of participants in both study groups had hSBA titers ≥1:8 for the four meningococcal serogroups at Day 30. Reactogenicity profiles were comparable between groups. These Phase III data in adolescents and adults show that MenACYW-TT boosts the immune response in those primed with MCV4 vaccines 4-10 y previously, irrespective of whether MCV4-DT or MCV4-CRM was used for priming.",2020,inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30.,"['Quadrivalent meningococcal conjugate vaccine (MCV4)-primed individuals aged ≥15\xa0y (n\xa0=\xa0810', 'adolescents and adults']","['single booster dose of MenACYW-TT', 'quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'MCV4-DT or MCV4-CRM', 'MCV4-DT', 'licensed MCV4 (Menactra®; MCV4-DT']","['Immunogenicity and safety', 'Reactogenicity profiles', 'hSBA titers']","[{'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C1567129', 'cui_str': 'Menactra'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",810.0,0.186252,inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30.,"[{'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Áñez', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hedrick', 'Affiliation': 'Kentucky Pediatric/Adult Research , Bardstown, KY, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Simon', 'Affiliation': 'Private Practice , Nicholasville, KY, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'J. Lewis Research , Salt Lake City, UT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeanfreau', 'Affiliation': 'MedPharmics , Metairie, LA, USA.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Yau', 'Affiliation': 'Global Biostatistical Sciences, Sanofi Pasteur , Toronto, ON, Canada.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Global Biostatistical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1733867']
391,32211778,A laboratory study on the effects of wind turbine noise on sleep: results of the polysomnographic WiTNES study.,"STUDY OBJECTIVES


Assess the physiologic and self-reported effects of wind turbine noise (WTN) on sleep.
METHODS


Laboratory sleep study (n = 50 participants: n = 24 living close to wind turbines and n = 26 as a reference group) using polysomnography, electrocardiography, salivary cortisol, and questionnaire endpoints. Three consecutive nights (23:00-07:00): one habituation followed by a randomized quiet Control and an intervention night with synthesized 32 dB LAEq WTN. Noise in WTN nights simulated closed and ajar windows and low and high amplitude modulation depth.
RESULTS


There was a longer rapid eye movement (REM) sleep latency (+16.8 min) and lower amount of REM sleep (-11.1 min, -2.2%) in WTN nights. Other measures of objective sleep did not differ significantly between nights, including key indicators of sleep disturbance (sleep efficiency: Control 86.6%, WTN 84.2%; wakefulness after sleep onset: Control 45.2 min, WTN 52.3 min; awakenings: Control n = 11.4, WTN n = 11.5) or the cortisol awakening response. Self-reported sleep was consistently rated as worse following WTN nights, and individuals living close to wind turbines had worse self-reported sleep in both the Control and WTN nights than the reference group.
CONCLUSIONS


Amplitude-modulated continuous WTN may impact on self-assessed and some aspects of physiologic sleep. Future studies are needed to generalize these findings outside of the laboratory and should include more exposure nights and further examine possible habituation or sensitization.",2020,"Other measures of objective sleep did not differ significantly between nights, including key indicators of sleep disturbance (sleep efficiency: Control 86.6%, WTN 84.2%; wakefulness after sleep onset: Control 45.2 min, WTN 52.3 min; awakenings: Control n=11.4, WTN n=11.5) or the cortisol awakening response.","['n=24 living close to wind turbines, n=26 as a reference group) using', 'Laboratory sleep study (n=50 participants']","['wind turbine noise (WTN', 'wind turbine noise', 'habituation followed by a randomized quiet Control and an intervention night with synthesized 32 dB LAEq WTN']","['Self-reported sleep', 'longer REM sleep latency', 'objective sleep', 'sleep disturbance (sleep efficiency', 'REM sleep', 'polysomnography, electrocardiography, salivary cortisol and questionnaire endpoints', 'sleep', 'cortisol awakening response']","[{'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Sleep, Fast-Wave'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",50.0,0.0184545,"Other measures of objective sleep did not differ significantly between nights, including key indicators of sleep disturbance (sleep efficiency: Control 86.6%, WTN 84.2%; wakefulness after sleep onset: Control 45.2 min, WTN 52.3 min; awakenings: Control n=11.4, WTN n=11.5) or the cortisol awakening response.","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Smith', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Ögren', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Thorsson', 'Affiliation': 'Division of Applied Acoustics, Department of Civil and Environmental Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Laith', 'Initials': 'L', 'LastName': 'Hussain-Alkhateeb', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eja', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'Department of Architecture and the Built Environment, Lund University, Lund, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Forssén', 'Affiliation': 'Division of Applied Acoustics, Department of Civil and Environmental Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ageborg Morsing', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Persson Waye', 'Affiliation': 'Department of Occupational and Environmental Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Sleep,['10.1093/sleep/zsaa046']
392,32055002,Survival outcomes and risk group validation from SWOG S0925: a randomized phase II study of cixutumumab in new metastatic hormone-sensitive prostate cancer.,"BACKGROUND


Cixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable prostate-specific antigen (PSA) rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints.
METHODS


We randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan-Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk.
RESULTS


No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88). At baseline, 105/198 (53.0%) patients had high-risk features and 119/210 (56.7%) had high-volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high-risk (HR 1.89 [1.29-2.80]; p = 0.001) and high-volume (HR 2.75 [1.84-4.10]; p < 0.0001) disease. Disease volume was a better fit to survival data than risk group (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99-6.95]; p < 0.0001) or >4.0 ng/mL (HR 7.13 [4.24-11.9]; p < 0.0001).
CONCLUSIONS


In new metastatic hormone-sensitive prostate cancer, addition of cixutumumab to androgen deprivation did not improve survival. Baseline risk and disease volume carried prognostic value for this distinct trial population, although disease volume added more prognostic information. PSA treatment response was a strong intermediate endpoint for survival.",2020,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","['patients with new metastatic hormone-sensitive prostate cancer', '210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm', 'new metastatic hormone-sensitive prostate cancer']",['cixutumumab'],"['Inferior survival', 'radiographic progression-free survival', 'inferior survival', 'Survival outcomes', 'overall survival, radiographic progression-free survival, and castration resistance-free survival', 'castration resistance-free survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C2699335'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[{'cui': 'C2699335'}],"[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}]",210.0,0.28146,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","[{'ForeName': 'Risa L', 'Initials': 'RL', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mai T', 'Initials': 'MT', 'LastName': 'Duong', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology, Las Vegas, NV, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, TX, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA. evanyu@uw.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0210-x']
393,32212342,Nucleus Hybrid S12: Multicenter Clinical Trial Results.,"OBJECTIVES/HYPOTHESIS


The use of a short 10-mm/10-electrode cochlear implant to preserve low-frequency residual hearing was investigated. This report describes the 12-month outcomes of this multicenter clinical trial.
STUDY DESIGN


Single-subject design.
METHODS


Twenty-eight subjects with low-frequency hearing at or better than 60 dB HL at 500 Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear. Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences was collected pre- and postoperatively at 3, 6, and 12 months. Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire was also collected pre- and postoperatively.
RESULTS


Functional hearing preservation was accomplished in 96% of subjects. At 3 and 6 months, 86% of the 28 subjects had maintained functional hearing. By 12 months, 23 out of 27 subjects (85%) had maintained functional hearing (one subject with functional hearing at 6 months withdrew from the study prior to the 12-month visit). Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids. Furthermore, preoperative to 12 months postoperative subjective ratings showed significant improvements for the SSQ.
CONCLUSIONS


This study demonstrates that a high degree of hearing preservation enabling acoustic-electric hearing and improvement in speech understanding in quiet and in noise can be accomplished using a short-electrode 10-mm cochlear implant.
LEVEL OF EVIDENCE


2c Laryngoscope, 130:E548-E558, 2020.",2020,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"['Nucleus Hybrid S12', 'Twenty-eight subjects with low-frequency hearing at or better than 60\u2009dB HL at 500\u2009Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear']",['hearing preservation enabling acoustic-electric hearing'],"['Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire', 'Functional hearing preservation', 'Speech perception', 'Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences', 'maintained functional hearing', 'everyday listening condition']","[{'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439498', 'cui_str': 'decibel hearing level'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018780', 'cui_str': 'Hearing Loss, High-Frequency'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}]","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",28.0,0.0168716,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"[{'ForeName': 'Camille C', 'Initials': 'CC', 'LastName': 'Dunn', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Cochlear Americas, Centennial, Colorado, U.S.A.'}, {'ForeName': 'Marlan R', 'Initials': 'MR', 'LastName': 'Hansen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Gantz', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}]",The Laryngoscope,['10.1002/lary.28628']
394,32143392,Brain Breaks® Physical Activity Solutions in the Classroom and on Attitudes toward Physical Activity: A Randomized Controlled Trial among Primary Students from Eight Countries.,"Classroom-based physical activity (PA) interventions have received considerable attention due to improvements seen in academic achievement, classroom behaviors, and attitude toward PA. The purpose of this study was to evaluate the effectiveness of the Brain Breaks® Physical Activity Solutions in changing children's attitudes toward PA. Students ( N  = 3036) aged 8-11 years from schools in Croatia, Lithuania, Macedonia, Poland, Romania, Serbia, South Africa, and Turkey were randomly assigned to either a control or an experimental group. The experimental group received Brain Breaks® videos during classroom sessions throughout the four months of intervention. Student attitudes toward PA were measured using the Attitudes toward Physical Activity Scale (APAS) before and after the intervention. Repeated measures ANOVA indicated a time interaction effect for all APAS variables except fitness. Time-by-group interaction effects with different effect sizes were found for most APAS variables, with the greatest gain effect noted in the experimental group for self-efficacy, followed by learning from the videos concerning PA benefits, exercise importance, and enjoyment from engaging in PA. This study provides evidence supporting Brain Breaks® in terms of learning experience, attitudes towards PA, and personal motivation. Using exercise videos is recommended as an interactive, technology-based PA solution that can be easily integrated into the school setting.",2020,"Time-by-group interaction effects with different effect sizes were found for most APAS variables, with the greatest gain effect noted in the experimental group for self-efficacy, followed by learning from the videos concerning PA benefits, exercise importance, and enjoyment from engaging in PA.","['Students ( N  = 3036) aged 8-11 years from schools in Croatia, Lithuania, Macedonia, Poland, Romania, Serbia, South Africa, and Turkey', 'Primary Students from Eight Countries', ""changing children's attitudes toward PA""]","['Brain Breaks® Physical Activity Solutions', 'Brain Breaks® videos', 'Classroom-based physical activity (PA) interventions']","['Attitudes toward Physical Activity', 'Attitudes toward Physical Activity Scale (APAS']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C0206004', 'cui_str': 'Macedonia, Former Yugoslave Republic of'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0916843', 'cui_str': ""P(1),P(7)-di(adenosine-5')-heptaphosphate""}]",3036.0,0.0160292,"Time-by-group interaction effects with different effect sizes were found for most APAS variables, with the greatest gain effect noted in the experimental group for self-efficacy, followed by learning from the videos concerning PA benefits, exercise importance, and enjoyment from engaging in PA.","[{'ForeName': 'Magdalena Mo Ching', 'Initials': 'MMC', 'LastName': 'Mok', 'Affiliation': 'Graduate Institute of Educational Information and Measurement, National Taichung University of Education, 140 Minsheng Road, West District, Taichung City 40306, Taiwan.'}, {'ForeName': 'Ming-Kai', 'Initials': 'MK', 'LastName': 'Chin', 'Affiliation': 'The Foundation for Global Community Health, 1550 W Horizon Ridge Pkwy Ste R #206, Henderson, NV 89012, USA.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Korcz', 'Affiliation': 'Department of Didactics of Physical Activity, Poznan University of Physical Education, Krolowej Jadwigi 27/39, 61-871 Poznan, Poland.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Popeska', 'Affiliation': 'Faculty of Educational Sciences, Goce Delcev University, Krste Misirkov 10-A, 2000 Stip, Macedonia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Edginton', 'Affiliation': 'Department of Health, Recreation and Community Services, 105 Human Performance Center, University of Northern Iowa, 105, Cedar Falls, IA 50614-0156, USA.'}, {'ForeName': 'Fatma Sacli', 'Initials': 'FS', 'LastName': 'Uzunoz', 'Affiliation': 'School of Sport Sciences and Technology, Department of Coaching Education, Nevşehir Hacı Bektaş Veli University, H Block, 1st Floor, Room 1, 50300 Nevşehir, Turkey.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Podnar', 'Affiliation': 'University of Zagreb, Faculty of Kinesiology, Horvacanski zavoj 15, 10000 Zagreb, Croatia.'}, {'ForeName': 'Dané', 'Initials': 'D', 'LastName': 'Coetzee', 'Affiliation': 'Physical Activity, Sport and Recreation (PhASRec), Focus Area, School of Human Movement Sciences, Faculty of Health Sciences, North-West University, Potchefstroom Campus, South Africa.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Georgescu', 'Affiliation': 'Department of Physical Education and Sport, University of Pitesti, Targul din Vale, 1, 110040 Pitesti, Romania.'}, {'ForeName': 'Arunas', 'Initials': 'A', 'LastName': 'Emeljanovas', 'Affiliation': 'Institute of Health Sciences, Medical Faculty, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Pasic', 'Affiliation': 'Primary school Ivo Andric, Ivana Micurina, 38, 11090 Belgrade, Serbia.'}, {'ForeName': 'Govindasamy', 'Initials': 'G', 'LastName': 'Balasekaran', 'Affiliation': 'Physical Education and Sports Science, National Institute of Education, Nanyang Technological University, 1s Nanyang Walk,Singapore SG 637616, Singapore.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, SC 29208, USA.'}, {'ForeName': 'J Larry', 'Initials': 'JL', 'LastName': 'Durstine', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, SC 29208, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17051666']
395,31391203,Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).,"OBJECTIVE


GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort.
RESEARCH DESIGN AND METHODS


Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c  6.8-8.5% (51-69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine.
RESULTS


At baseline, GRADE's 5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino. Duration of diabetes was 4.2 ± 2.8 years, with mean HbA 1c  of 7.5 ± 0.5% (58 ± 5.3 mmol/mol), BMI of 34.3 ± 6.8 kg/m 2 , and metformin dose of 1,944 ± 204 mg/day. Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke. Applying GRADE inclusion criteria to NHANES indicates enrollment of a representative cohort with T2DM on metformin monotherapy (NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease).
CONCLUSIONS


The GRADE cohort represents patients with T2DM treated with metformin requiring a second diabetes medication. GRADE will inform decisions about the clinical effectiveness of the addition of four classes of diabetes medications to metformin.",2019,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","['Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 1c  6.8-8.5% (51-69 mmol/mol), prescribed', 'requiring a second diabetes medication', '5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino', 'people with type 2 diabetes (T2DM', 'GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort', 'Diabetes', 'NHANES cohort average age, 57.9 years; mean HbA 1c , 7.4% [57 mmol/mol]; BMI, 33.2 kg/m 2 ; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease']","['metformin monotherapy', 'metformin', 'glimepiride, sitagliptin, liraglutide, or insulin glargine']","['history of hypertension', 'history of heart attack or stroke']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0449238', 'cui_str': 'Duration (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0376344', 'cui_str': 'National Health and Nutrition Examination Survey'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",69.0,0.0711735,"Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke.","[{'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA grademail@bsc.gwu.edu.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The George Washington University Biostatistics Center, Rockville, MD.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Hermes J', 'Initials': 'HJ', 'LastName': 'Florez', 'Affiliation': 'University of Miami, Geriatric Research, Education, and Clinical Center-Miami Veterans Affairs Healthcare System, Miami, FL.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hox', 'Affiliation': 'Pacific Health Research & Education Institute, Honolulu, HI.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kuhn', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Underkofler', 'Affiliation': 'University of Colorado, Denver, Denver, CO.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0901']
396,31543516,"Calcium: magnesium intake ratio and colorectal carcinogenesis, results from the prostate, lung, colorectal, and ovarian cancer screening trial.","BACKGROUND


We aimed to evaluate the associations between calcium and various stages of colorectal carcinogenesis and whether these associations are modified by the calcium to magnesium (Ca:Mg) ratio.
METHODS


We tested our hypotheses in the prostate lung, colorectal and ovarian cancer screening trial.
RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05). This inverse trend was mainly in participants with Ca:Mg ratios between 1.7 and 2.5 (P- trend  = 0.05). No significant associations were observed for metachronous adenoma. Calcium intake was inversely associated with CRC (P- trend  = 0.03); the association was primarily present for distal CRC (P- trend  = 0.01). The inverse association between calcium and distal CRC was further modified by the Ca:Mg ratio (P- interaction  < 0.01); significant dose-response associations were found only in participants with a Ca:Mg ratio between 1.7 and 2.5 (P- trend  = 0.04). No associations for calcium were found in the Ca:Mg ratio above 2.5 or below 1.7.
CONCLUSION


Higher calcium intake may be related to reduced risks of incident advanced and/or synchronous adenoma and incident distal CRC among subjects with Ca:Mg intake ratios between 1.7 and 2.5.",2019,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","['subjects with Ca', 'participants with Ca']",['Calcium: magnesium'],"['Calcium intake', 'Mg intake ratios', 'metachronous adenoma']",[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",,0.0314611,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ayush', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Giovannucci', 'Affiliation': 'Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd L', 'Initials': 'TL', 'LastName': 'Edwards', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. qi.dai@vanderbilt.edu.'}]",British journal of cancer,['10.1038/s41416-019-0579-2']
397,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND


Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition.
METHODS


In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment.
RESULTS


All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
CONCLUSIONS


Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up.
IMPACT


The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up. The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8']
398,32205547,Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.,"BACKGROUND


The present trial was designed to assess whether individualized strategies of fluid administration using a noninvasive plethysmographic variability index could reduce the postoperative hospital length of stay and morbidity after intermediate-risk surgery.
METHODS


This was a multicenter, randomized, nonblinded parallel-group clinical trial conducted in five hospitals. Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled. Individualized hemodynamic management aimed to achieve a plethysmographic variability index under 13%, and the standard management strategy aimed to maintain a mean arterial pressure above 65 mmHg during general anesthesia. The primary outcome was the postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient.
RESULTS


In total, 447 patients were randomized, and 438 were included in the analysis. The mean hospital length of stay ± SD was 6 ± 3 days for the plethysmographic variability index group and 6 ± 3 days for the control group (adjusted difference, 0.0 days; 95% CI, -0.6 to 0.5; P = 0.860); the theoretical postoperative hospital length of stay was 4 ± 2 days for the plethysmographic variability index group and 4 ± 1 days for the control group (P = 0.238). In the plethysmographic variability index and control groups, serious postoperative cardiac complications occurred in 3 of 217 (1%) and 2 of 224 (1%) patients (P = 0.681), acute postoperative renal failure occurred in 9 (4%) and 8 (4%) patients (P = 0.808), the troponin Ic concentration was more than 0.06 μg/l within 5 days postoperatively for 6 (3%) and 5 (2%) patients (P = 0.768), and the postoperative arterial lactate measurements were 1.44 ± 1.01 and 1.43 ± 0.95 mmol/l (P = 0.974), respectively.
CONCLUSIONS


Among intermediate-risk patients having orthopedic surgery with general anesthesia, fluid administration guided by the plethysmographic variability index did not shorten the duration of hospitalization or reduce complications.",2020,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"['Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled', '447 moderate-risk major arthroplasty patients to', 'intermediate-risk patients having orthopedic surgery with general anesthesia', '447 patients were randomized, and 438 were included in the analysis', 'moderate-risk surgery patients', 'five hospitals']","['Plethysmographic-guided fluid management', 'plethysmographic-guided versus routine fluid management', 'Individualized Fluid Management']","['theoretical postoperative hospital length of stay', 'postoperative arterial lactate measurements', 'duration of hospitalization or reduce complications', 'serious postoperative cardiac complications', 'postoperative hospital length of stay and morbidity', 'acute postoperative renal failure', 'duration of hospitalization or complications', 'mean hospital length of stay ± SD', 'postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient', 'Fitness for discharge and actual hospital durations', 'troponin Ic concentration', 'noninvasive plethysmographic variability index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0340276', 'cui_str': 'Postoperative cardiac complication (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2585625', 'cui_str': 'Acute postoperative renal failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",447.0,0.161995,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"[{'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': 'From the Anesthesiology and Critical Care Medicine Department (M.-O.F., S.L., W.G., G.D., J.-L.H.) the INSERM COMETE 1075 Unit, Orthopedic Department, (C.H.) the Biostatistics Department (J.-J.P.), Normandy University, Caen University Hospital, Caen, France Anesthesiology and Critical Care Medicine Department, Lille University Hospital, Lille, France (B.T., M.H.) Anesthesiology and Intensive Care Medicine Department, Hospital of Catholic Institute of Lille, Saint Philibert Hospital, Lomme, France (C.-E.B., V.C.) Anesthesiology and Critical Care Medicine Department, Rouen University Hospital, Charles Nicolle Hospital, Rouen, France (V.C.) Anesthesiology and Critical Care Department, Amiens University Hospital, Amiens, France (D.T., E.L.) Research Unit on Simplified Care of Complex Surgical Patients, Jules Verne University of Picardy, Amiens, France (E.L.). Caen University Hospital, Caen, France Caen University Hospital, Caen, France Amiens Picardie University Hospital, Amiens, France Amiens Picardie University Hospital, Amiens, France Lille University Hospital, Lille, France Lille University Hospital, Lille, France Hospital of Catholic Institute of Lille, Lomme, France Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Hospital of Catholic Institute of Lille Clinical Research Department, Lille University Hospital Clinical Research Department, Lille University Hospital Clinical Research Department, Amiens Picardie University Hospital.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lemoine', 'Affiliation': ''}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tavernier', 'Affiliation': ''}, {'ForeName': 'Chems-Eddine', 'Initials': 'CE', 'LastName': 'Bouchakour', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Colas', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Houard', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greub', 'Affiliation': ''}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Daccache', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hulet', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Compère', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Taing', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Lorne', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003260']
399,31610828,Cost-Utility Analysis of Pembrolizumab Versus Chemotherapy as First-Line Treatment for Metastatic Non-Small Cell Lung Cancer With Different PD-L1 Expression Levels.,"To evaluate the cost-utility of pembrolizumab versus chemotherapy as the first-line setting for metastatic non-small cell lung cancer (NSCLC) from the US health care system perspective, a Markov model was developed to compare the lifetime cost and effectiveness of pembrolizumab versus chemotherapy for untreated metastatic NSCLC, based on the clinical data derived from phase III randomized controlled trial (KEYNOTE-042; ClinicalTrials.gov; NCT02220894). Weibull distribution was fitted to simulate the parametric survival functions. Drug costs were collected from official websites, and utility values were obtained from published literature. Total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were computed as primary output indicators. The impact of different PD-L1 expression levels on ICER was also evaluated. One-way and probabilistic sensitivity analyses were performed to assess the model uncertainty. Compared with chemotherapy, patients treated with pembrolizumab provided an additional 1.13, 1.01, and 0.59 QALYs in patients with PD-L1 expression levels of ≥50%, ≥20%, and ≥1%, with corresponding incremental cost of 53,784, 47,479, and 39,827, respectively. The resultant ICERs of pembrolizumab versus chemotherapy were 47,596, 47,184, and 68,061/QALY, in three expression levels of PD-L1, respectively, all of which did not exceed the WTP threshold of 180,000/QALY. Probability sensitivity analysis outcome supported that pembrolizumab exhibited evident advantage over chemotherapy to be cost-effective. One-way sensitivity analysis found that ICERs were most sensitive to utility value of pembrolizumab in progression survival state. All the adjustment of parameters did not qualitatively change the result. For treatment-naive, metastatic NSCLC patients with PD-L1 + , pembrolizumab was estimated to be cost-effective compared with chemotherapy for all PD-L1 expression levels at a WTP threshold of 180,000/QALY in the context of the US health care system.",2020,"Compared with chemotherapy, patients treated with pembrolizumab provided an additional 1.13, 1.01 and 0.59 QALYs in patients with PD-L1 expression levels of ≥50%, ≥20%, and ≥1%, with corresponding incremental cost of $53,784, $47,479 and $39,827 respectively.",['metastatic non-small cell lung cancer (NSCLC'],"['pembrolizumab', 'pembrolizumab versus chemotherapy']","['resultant ICERs of pembrolizumab versus chemotherapy', 'Drug cost', 'Total costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs', 'life-time cost and effectiveness']","[{'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.063284,"Compared with chemotherapy, patients treated with pembrolizumab provided an additional 1.13, 1.01 and 0.59 QALYs in patients with PD-L1 expression levels of ≥50%, ≥20%, and ≥1%, with corresponding incremental cost of $53,784, $47,479 and $39,827 respectively.","[{'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Fujian Medical UniversityTaijiang, FuzhouP.R. China.'}, {'ForeName': 'Shaohong', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Fujian Medical UniversityTaijiang, FuzhouP.R. China.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Fujian Medical UniversityTaijiang, FuzhouP.R. China.'}, {'ForeName': 'Lixian', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'College of Pharmacy, Texas A&M UniversityCollege Station, TXUSA.'}, {'ForeName': 'Meiyue', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Fujian Medical UniversityTaijiang, FuzhouP.R. China.'}, {'ForeName': 'Rao', 'Initials': 'R', 'LastName': 'Xin', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Fujian Medical UniversityTaijiang, FuzhouP.R. China.'}, {'ForeName': 'Pinfang', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Fujian Medical UniversityTaijiang, FuzhouP.R. China.'}, {'ForeName': 'Xiongwei', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Fujian Medical UniversityTaijiang, FuzhouP.R. China.'}]",Oncology research,['10.3727/096504019X15707883083132']
400,32404343,Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study.,"OBJECTIVE


To investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission.
METHODS


The PREDICTRA phase IV, randomised, double-blind (DB) study (Im P act of  R esidual Inflammation Detected via Imaging T E chniques,  D rug Levels, and Patient Characteristics on the Outcome of Dose Taper I ng of Adalimumab in  C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40 mg every other week who were in sustained remission ≥6 months. After a 4-week, open-label lead-in (OL-LI) period, patients were randomised 5:1 to DB adalimumab taper (every 3 weeks) or withdrawal (placebo) for 36 weeks. The primary endpoint was the association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence.
RESULTS


Of 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies.
CONCLUSIONS


Approximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence.
TRIAL REGISTRATION NUMBER


NCT02198651, EudraCT 2014-001114-26.",2020,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"['patients with rheumatoid arthritis (RA) in sustained remission', 'Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission', 'C linical Remission Rheumatoid Ar T hritis ( RA ) Patients) enrolled patients with RA receiving adalimumab 40\u2009mg every other week who were in sustained remission ≥6 months', '146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms', 'patients with rheumatoid arthritis who are in long-standing clinical remission']","['DB adalimumab taper (every 3 weeks) or withdrawal (placebo', 'adalimumab tapering or withdrawal', 'Adalimumab', 'tapered adalimumab']","['association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence', 'Baseline MRI inflammation', 'DB baseline disease characteristics or adalimumab concentration', 'clinical remission', 'Time to flare']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0412709', 'cui_str': 'MRI of wrist'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.196623,None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK p.emery@leeds.ac.uk.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Naredo', 'Affiliation': 'Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Sinigaglia', 'Affiliation': 'Department of Rheumatology and Medical Sciences, Centro Specialistico Ortopedico Traumatologico Pini-CTO, Milan, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lagunes', 'Affiliation': 'Global Medical Affairs Rheumatology, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Koenigsbauer', 'Affiliation': 'Data and Statistical Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217246']
401,32207048,"Effect of the ""Recruitment"" Maneuver on Respiratory Mechanics in Laparoscopic Sleeve Gastrectomy Surgery.","PURPOSE


LSG surgery is used for surgical treatment of morbid obesity. Obesity, anesthesia, and pneumoperitoneum cause reduced pulmoner functions and a tendency for atelectasis. The alveolar ""recruitment"" maneuver (RM) keeps airway pressure high, opening alveoli, and increasing arterial oxygenation. The aim of our study is to research the effect on respiratory mechanics and arterial blood gases of performing the RM in LSG surgery.
MATERIALS AND METHODS


Sixty patients undergoing LSG surgery were divided into two groups (n = 30) Patients in group R had the RM performed 5 min after desufflation with 100% oxygen, 40 cmH 2 O pressure for 40 s. Group C had standard mechanical ventilation. Assessments of respiratory mechanics and arterial blood gases were made in the 10th min after induction (T1), 10th min after insufflation (T2), 5th min after desufflation (T3), and 15th min after desufflation (T4). Arterial blood gases were assessed in the 30th min (T5) in the postoperative recovery unit.
RESULTS


In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum. At T4, the compliance in the recruitment group was higher. In both groups, there was an increase in PIP with pneumoperitoneum and after desufflation this was identified to reduce to levels before pneumoperitoneum.
CONCLUSION


Adding the RM to PEEP administration for morbidly obese patients undergoing LSG surgery is considered to be effective in improving respiratory mechanics and arterial blood gas values and can be used safely.",2020,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","['morbidly obese patients undergoing LSG surgery', 'Laparoscopic Sleeve Gastrectomy Surgery', 'Sixty patients undergoing LSG surgery']","['RM performed 5\xa0min after desufflation with 100% oxygen, 40\xa0cmH 2 O pressure for 40\xa0s. Group C had standard mechanical ventilation', 'Recruitment"" Maneuver']","['Arterial blood gases', 'respiratory mechanics and arterial blood gases', 'PIP with pneumoperitoneum', 'Respiratory Mechanics', 'respiratory mechanics and arterial blood gas values']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0255194,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Sümer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. isumer@bezmialem.edu.tr.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Topuz', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Alver', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, İstanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Umutoglu', 'Affiliation': 'İstanbul Acıbadem Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mefkur', 'Initials': 'M', 'LastName': 'Bakan', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Seniyye Ülgen', 'Initials': 'SÜ', 'LastName': 'Zengin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Coşkun', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salihoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cerrahpasa Faculty of Medicine, İstanbul University Cerrahpasa, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04551-y']
402,32406371,Slow-oscillation activity is reduced and high frequency activity is elevated in older adults with insomnia.,"STUDY OBJECTIVES


High-frequency electroencephalographic activity (> 16 Hz activity) is often elevated during nonrapid eye movement sleep among individuals with insomnia, in line with the hyperarousal theory of insomnia. Evidence regarding sleep depth marked by slow-wave activity (< 4 Hz) is more mixed. Distinguishing subcomponents of slow-wave activity (slow-oscillation [< 1 Hz] or delta activity [1-4 Hz)]) may be critical in understanding these discrepancies, given that these oscillations have different neural generators and are functionally distinct. Here we tested the effects of insomnia diagnosis and insomnia treatment on nonrapid eye movement electroencephalography in older adults, distinguishing slow-oscillation and delta power.
METHODS


In 93 older adults with insomnia and 71 good sleeper control participants (mean ages 68 years), effects of insomnia and cognitive behavioral therapy for insomnia (insomnia group only) on electroencephalographic spectral power were analyzed. Main effects and interactions with nonrapid eye movement period were assessed for the following frequency bands: slow-oscillation (0.5-1 Hz), delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), sigma (12-16 Hz), and beta (16-32 Hz).
RESULTS


Slow-oscillation absolute and relative power were lower in the insomnia group compared with controls. There were no group differences in delta power. Insomnia was also associated with elevated 4-32 Hz absolute and relative power. After cognitive behavioral therapy for insomnia, absolute sigma and beta activity decreased.
CONCLUSIONS


Deficits in slow-wave activity in insomnia are specific to the slow-oscillation. Elevated high frequency activity is reduced for sigma and beta power following cognitive behavioral therapy for insomnia . These findings inform the pathophysiology of insomnia, including the mechanisms underlying cognitive behavioral therapy for insomnia in older adults.",2020,There were no group differences in delta power.,"['93 older adults with insomnia and 71 good sleeper control participants (mean ages 68), effects of insomnia and cognitive behavioral therapy for insomnia (CBTI) (insomnia group only) on EEG spectral power were analyzed', 'individuals with insomnia, in line with the hyperarousal theory of insomnia', 'older adults with insomnia', 'older adults']",['insomnia diagnosis and insomnia treatment'],"['delta power', 'Insomnia', 'absolute sigma and beta activity decreased', 'Slow-oscillation absolute and relative power']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",93.0,0.0414553,There were no group differences in delta power.,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Hogan', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gisela M', 'Initials': 'GM', 'LastName': 'Delgado', 'Affiliation': ""St. Luke's Warren Campus, Phillipsburg, New Jersey.""}, {'ForeName': 'Martica H', 'Initials': 'MH', 'LastName': 'Hall', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vishwajit L', 'Initials': 'VL', 'LastName': 'Nimgaonkar', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Buysse', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Wilckens', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8568']
403,32404342,"Canakinumab for Treatment of Adult-Onset Still's Disease to Achieve Reduction of Arthritic Manifestation (CONSIDER): phase II, randomised, double-blind, placebo-controlled, multicentre, investigator-initiated trial.","BACKGROUND


Inhibition of interleukin (IL)-1 represents a promising treatment option in adult-onset Still's disease (AOSD).
OBJECTIVE


To investigate the efficacy and safety of canakinumab in patients with AOSD and active joint involvement by means of a multicentre, double-blind, randomised, placebo-controlled trial.
METHODS


Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4 each) were treated with canakinumab (4 mg/kg, maximum 300 mg subcutaneous every 4 weeks) or placebo. The primary endpoint was the proportion of patients with a clinically relevant reduction in disease activity at week 12 as determined by the change in disease activity score (ΔDAS28>1.2).
RESULTS


At enrolment, patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the placebo group, respectively. In the intention-to-treat analysis, 12 patients (67%) in the canakinumab group and 7 patients (41%) in the placebo group fulfilled the primary outcome criterion (p=0.18). In the per-protocol analysis, significantly higher American College of Rheumatology (ACR) 30% (61% vs 20%, p=0.033), ACR 50% (50% vs 6.7%, p=0.009) and ACR 70% (28% vs 0%, p=0.049) response rates were observed in the canakinumab group compared with the placebo group. Two patients in the canakinumab group experienced a serious adverse event.
CONCLUSION


Although the study was terminated prematurely and the primary endpoint was not achieved, treatment with canakinumab led to an improvement of several outcome measures in AOSD. The overall safety findings were consistent with the known profile of canakinumab. Thus, our data support indication for IL-1 inhibition with canakinumab in AOSD.",2020,"Two patients in the canakinumab group experienced a serious adverse event.
","[""adult-onset Still's disease (AOSD"", 'patients had high active disease with a mean DAS28(ESR) of 5.4 in the canakinumab and 5.3 in the', 'patients with AOSD and active joint involvement by means of a multicentre', 'Adult-Onset', 'Patients with AOSD and active joint involvement (tender and swollen joint counts of ≥4\u2009each']","['canakinumab', 'interleukin (IL)-1', 'Canakinumab', 'canakinumab (4\u2009mg/kg, maximum 300\u2009mg subcutaneous every 4 weeks) or placebo', 'placebo']","['several outcome measures in AOSD', 'response rates', 'American College of Rheumatology (ACR', 'disease activity score (ΔDAS28>1.2', 'serious adverse event', 'proportion of patients with a clinically relevant reduction in disease activity', 'efficacy and safety']","[{'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0085253', 'cui_str': ""Adult onset Still's disease""}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.675758,"Two patients in the canakinumab group experienced a serious adverse event.
","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kedor', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany claudia.kedor@charite.de.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Listing', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Zernicke', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Weiß', 'Affiliation': 'Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Behrens', 'Affiliation': 'CIRI/Rheumatology and Fraunhofer TMP, Goethe-University, Frankfurt, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Blank', 'Affiliation': 'Internal Medicine 5, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Joerg Christoph', 'Initials': 'JC', 'LastName': 'Henes', 'Affiliation': 'Centre for Interdisciplinary Clinical Immunology, Rheumatology and Auto-inflammatory Diseases and Department of Internal Medicine II (Oncology, Haematology, Immunology, Rheumatology, Pulmology), University Hospital Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Kekow', 'Affiliation': 'Clinic of Rheumatology and Orthopaedics, Otto-von-Guericke University Magdeburg, Vogelsang-Gommern, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubbert-Roth', 'Affiliation': 'Division of Rheumatology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Department of Rheumatology, University of Munich, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Seipelt', 'Affiliation': 'Abteilung Rheumatologie und Klinische Immunologie, Immanuel Krankenhaus Berlin, Standort Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Specker', 'Affiliation': 'Klinik für Rheumatologie und Klinische Immunologie, KEM Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Feist', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217155']
404,32067873,Effect of an Intervention for Obesity and Depression on Patient-Centered Outcomes: An RCT.,"INTRODUCTION


An integrated collaborative care intervention was successful for treating comorbid obesity and depression. The effect of the integrated intervention on secondary outcomes of quality of life and psychosocial functioning were examined, as well as whether improvements in these secondary outcomes were correlated with improvements in the primary outcomes of weight and depressive symptoms.
STUDY DESIGN


This RCT compared an integrated collaborative care intervention for obesity and depression to usual care. Data were analyzed in 2018.
SETTING/PARTICIPANTS


Adult primary care patients (n=409) with a BMI ≥30 (≥27 if Asian) and 9-Item Patient Health Questionnaire score ≥10 were recruited from September 30, 2014 to January 12, 2017 from primary care clinics in Northern California.
INTERVENTION


The 12-month intervention integrated a behavioral weight loss program and problem-solving therapy with as-needed antidepressant medications for depression.
MAIN OUTCOME MEASURES


A priori secondary outcomes included health-related quality of life (Short Form-8 Health Survey), obesity-specific quality of life (Obesity-Related Problems Scale), sleep disturbance and sleep-related impairment (Patient-Reported Outcomes Measurement Information System), and functional disability (Sheehan Disability Scale) at baseline and 6 and 12 months.
RESULTS


Participants randomized to the intervention experienced significantly greater improvements in obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability at 6 months but not 12 months. Improvements in obesity-related problems (β=0.01, 95% CI=0.01, 0.02) and sleep disturbance (β= -0.02, 95% CI= -0.04, 0) were associated with lower BMI. Improvements in the physical (β= -0.01, 95% CI= -0.01, 0) and mental health components (β= -0.02, 95% CI= -0.03, -0.02) of the Short Form-8 Health Survey as well as sleep disturbance (β=0.01, 95% CI=0.01, 0.02) and sleep-related impairment (β=0.01, 95% CI=0, 0.01) were associated with fewer depressive symptoms.
CONCLUSIONS


An integrated collaborative care intervention for obesity and depression that was shown previously to improve weight and depressive symptoms may also confer benefits for quality of life and psychosocial functioning over 6 months.
TRIAL REGISTRATION


This study is registered at clinicaltrials.gov NCT02246413.",2020,"RESULTS


Participants randomized to the intervention experienced significantly greater improvements in obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability at 6 months but not 12 months.","['Adult primary care patients (n=409) with a BMI ≥30 (≥27 if Asian) and 9-Item Patient Health Questionnaire score ≥10 were recruited from September 30, 2014 to January 12, 2017 from primary care clinics in Northern California']","['integrated intervention', 'integrated collaborative care intervention', 'behavioral weight loss program and problem-solving therapy with as-needed antidepressant medications']","['sleep disturbance', 'health-related quality of life (Short Form-8 Health Survey), obesity-specific quality of life (Obesity-Related Problems Scale), sleep disturbance and sleep-related impairment (Patient-Reported Outcomes Measurement Information System), and functional disability (Sheehan Disability Scale', 'quality of life and psychosocial functioning', 'sleep-related impairment', 'mental health components', 'depressive symptoms', 'obesity-related problems', 'weight and depressive symptoms', 'obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",0.0,0.14691,"RESULTS


Participants randomized to the intervention experienced significantly greater improvements in obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability at 6 months but not 12 months.","[{'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, California; Department of Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Kristen M J', 'Initials': 'KMJ', 'LastName': 'Azar', 'Affiliation': 'Sutter Health Research, Sutter Health, Palo Alto, California.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Department of Medicine and Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, California.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, California.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Medicine and Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois. Electronic address: maj2015@uic.edu.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.11.005']
405,31295363,"Higher dietary protein intake preserves lean body mass, lowers liver lipid deposition, and maintains metabolic control in participants with long-chain fatty acid oxidation disorders.","Medical nutrition therapy for long-chain fatty acid oxidation disorders (LC-FAODs) currently emphasizes fasting avoidance, restricted dietary long-chain fatty acid intake, supplementation with medium chain triglycerides, and increased carbohydrate intake. We hypothesize that increasing dietary protein intake relative to carbohydrate intake would preserve metabolic control yet induce physical benefits including reduced hepatic lipogenesis. Therefore, we compared two dietary approaches with similar fat intake but different carbohydrate to protein ratios in participants diagnosed with LC-FAODs. Thirteen participants were enrolled and randomized into either a high-protein (PRO) or a high-carbohydrate (CHO) diet for 4 months. Baseline and 4-month assessments included body composition, ectopic lipid deposition, and resting energy expenditure. End of study assessments also included total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity. At the end of the dietary intervention, both groups had similar energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads. Neither dietary group experienced worsening symptoms related to their LC-FAOD. Compared to the CHO group, the PRO group exhibited increased blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass while the CHO group lost lean mass. In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass. We propose that a modest increase in dietary protein along with fasting avoidance and fat restriction may improve body composition and energy expenditure in patients with LC-FAODs.",2019,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","['participants with long-chain fatty acid oxidation disorders', 'Thirteen participants', 'participants diagnosed with LC-FAODs', 'patients with LC-FAODs']","['high-protein (PRO) or a high-carbohydrate (CHO) diet', 'CHO', 'Medical nutrition therapy']","['total energy expenditure, metabolic responses to oral feedings, and whole-body fatty acid oxidation capacity', 'blood levels of short-chain acylcarnitines, reduced intrahepatic lipid content, and maintained lean body mass', 'body composition and energy expenditure', 'lean body mass, lowers liver lipid deposition', 'energy expenditure, fat and glucose oxidation rates, and glucolipid responses to mixed meal and oral glucose loads', 'worsening symptoms', 'body composition, ectopic lipid deposition, and resting energy expenditure']","[{'cui': 'C0522095', 'cui_str': 'Long chain fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet (finding)'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]","[{'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",13.0,0.0245497,"In patients with LC-FAODs, increasing protein intake maintained metabolic control, reduced liver fat without risk of metabolic decompensation, and helped preserve lean body mass.","[{'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'Gillingham', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Elizondo', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Behrend', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Matern', 'Affiliation': 'Biochemical Genetics Laboratory, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Schoeller', 'Affiliation': 'Department of Nutritional Sciences, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Purnell', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12155']
406,32201056,Changes in accommodative micro-fluctuations after wearing contact lenses of different optical designs.,"PURPOSE


Accommodative micro-fluctuations (AMF) are small dioptric changes during accommodation. The aim of this study was to evaluate and compare changes in AMF when wearing silicone hydrogel contact lenses of two different optical designs.
METHODS


A multi-centre, randomised, cross-over, non-dispensing study was conducted on 68 adapted contact lens wearers aged 25-35 years to compare AMF responses to a spherical and aspheric silicone hydrogel (comfilcon A) lens designs. A Righton Speedy ""i"" series Auto Refractometer in accommodation analyser mode was utilized before and after reading a standard text in font size 8 on an iPhone 5 for 20 min at a 25 cm viewing distance. Phone screen brightness was set by automatic adjustment mode and ambient illumination was controlled at all sites.
RESULTS


Mean ± SD AMF change from before to after the reading task was 2.25 ± 5.6 and 0.13 ± 5.7 (relative values) for the spherical and aspheric lens designs, respectively. The difference was statistically significant (P = 0.017, Paired t-test).
CONCLUSIONS


The smaller change in AMF when using an aspheric lens design suggests reduced ciliary muscle stress when reading print on a smart phone at a close distance for short periods (20 min). Contact lens wearers who frequently use digital devices and are experiencing eye strain may benefit from switching from a spherical design to one that incorporates aspheric optics.",2020,"Mean ± SD AMF change from before to after the reading task was 2.25 ± 5.6 and 0.13 ± 5.7 (relative values) for the spherical and aspheric lens designs, respectively.",['68 adapted contact lens wearers aged 25-35 years'],['spherical and aspheric silicone hydrogel (comfilcon A) lens designs'],"['accommodative micro-fluctuations', 'Mean\u2009±\u2009SD AMF change', 'ciliary muscle stress']","[{'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C2715682', 'cui_str': 'comfilcon A'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0559230', 'cui_str': 'Ciliary muscle structure (body structure)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",68.0,0.0425713,"Mean ± SD AMF change from before to after the reading task was 2.25 ± 5.6 and 0.13 ± 5.7 (relative values) for the spherical and aspheric lens designs, respectively.","[{'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kajita', 'Affiliation': 'Kajita Eye Clinic, Kyoei Building, 4F, 3-6-3, Shibaura, Minato-ku, Tokyo, Japan. Electronic address: Kajitamd1147@h5.dion.ne.jp.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Muraoka', 'Affiliation': 'CooperVision Japan, Inc., 2-36-13, Ebisu, Shibuya-Ku, Tokyo, Japan. Electronic address: Taku.Muraoka@jp.coopervision.com.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Orsborn', 'Affiliation': 'CooperVision Inc., San Ramon, CA, United States. Electronic address: GOrsborn@coopervision.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.03.003']
407,31895236,"Primary Arthroscopic Stabilization for a First-Time Anterior Dislocation of the Shoulder: Long-Term Follow-up of a Randomized, Double-Blinded Trial.","BACKGROUND


The aim of this study was to evaluate the long-term efficacy of arthroscopic Bankart repair (ABR).
METHODS


Eighty-eight patients with an age of ≤35 years who had sustained a primary anterior glenohumeral dislocation were enrolled in a single-center, double-blinded clinical trial. Subjects were randomized to receive either an arthroscopic washout (AWO) or ABR. Participants were reassessed after a minimum of 10 years postoperatively. Data regarding recurrent instability, revision surgery, satisfaction, and function (Disabilities of the Arm, Shoulder and Hand [DASH] and Western Ontario Shoulder Instability Index [WOSI]) scores were collected.
RESULTS


Sixty-five patients (74%; 32 in the AWO group and 33 in the ABR group) were included and had an average follow-up of 14.2 years (range,12 to 16 years). The rate of recurrent dislocation was significantly higher in the AWO group than the ABR group (47% and 12%, respectively; p = 0.002). Kaplan-Meier curves were plotted for event-free survival using recurrent instability and/or revision surgery as clinical end points. This analysis demonstrated a sustained significant difference between the groups at 10 years after surgery (58% for the AWO group versus 79% for the ABR group; log-rank test [Mantel-Cox]; p = 0.018). Long-term WOSI scores were significantly better in the ABR group. The presence of recurrent instability was associated with significantly poorer WOSI and DASH scores.
CONCLUSIONS


This study demonstrates a long-term benefit in overall shoulder stability and functional outcome in high-risk patients who have undergone ABR for first-time anterior dislocation.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The rate of recurrent dislocation was significantly higher in the AWO group than the ABR group (47% and 12%, respectively; p = 0.002).","['high-risk patients who have undergone ABR for first-time anterior dislocation', 'Sixty-five patients (74%; 32 in the AWO group and 33 in the ABR group) were included and had an average follow-up of 14.2 years (range,12 to 16 years', 'Eighty-eight patients with an age of ≤35 years who had sustained a primary anterior glenohumeral dislocation were enrolled in a single-center, double-blinded clinical trial']","['Primary Arthroscopic Stabilization', 'arthroscopic Bankart repair (ABR', 'arthroscopic washout (AWO) or ABR']","['WOSI and DASH scores', 'Long-term WOSI scores', 'rate of recurrent dislocation', 'recurrent instability, revision surgery, satisfaction, and function (Disabilities of the Arm, Shoulder and Hand [DASH] and Western Ontario Shoulder Instability Index [WOSI]) scores']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1265658', 'cui_str': 'Anterior dislocation'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0037005', 'cui_str': 'Glenohumeral Dislocation'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum (procedure)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",88.0,0.199169,"The rate of recurrent dislocation was significantly higher in the AWO group than the ABR group (47% and 12%, respectively; p = 0.002).","[{'ForeName': 'Liam Z', 'Initials': 'LZ', 'LastName': 'Yapp', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Nicholson', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Robinson', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00858']
408,32203065,"Double-blinded, placebo-controlled crossover trial to determine the effects of midodrine on blood pressure during cognitive testing in persons with SCI.","STUDY DESIGN


Clinical trial.
OBJECTIVES


Individuals with spinal cord injury (SCI) above T6 experience impaired descending cortical control of the autonomic nervous system, which predisposes them to hypotension. However, treatment of hypotension is uncommon in the SCI population because there are few safe and effective pharmacological options available. The primary aim of this investigation was to test the efficacy of a single dose of midodrine (10 mg), compared with placebo, to increase and normalize systolic blood pressure (SBP) between 110 and 120 mmHg during cognitive testing in hypotensive individuals with SCI. Secondary aims were to determine the effects of midodrine on cerebral blood flow velocity (CBFv) and global cognitive function.
SETTING


United States clinical research laboratory.
METHODS


Forty-one healthy hypotensive individuals with chronic (≥1-year post injury) SCI participated in this 2-day study. Seated SBP, CBFv, and cognitive performance were monitored before and after administration of identical encapsulated tablets, containing either midodrine or placebo.
RESULTS


Compared with placebo, midodrine increased SBP (4 ± 13 vs. 18 ± 24 mmHg, respectively; p < 0.05); however, responses varied widely with midodrine (-15.7 to +68.6 mmHg). Further, the proportion of SBP recordings within the normotensive range did not improve during cognitive testing with midodrine compared with placebo. Although higher SBP was associated with higher CBFv (p = 0.02), global cognitive function was not improved with midodrine.
CONCLUSIONS


The findings indicate that midodrine increases SBP and may be beneficial in some hypotensive patients with SCI; however, large heterogeneity of responses to midodrine suggests careful monitoring of patients following administration.
CLINICAL TRIALS REGISTRATION


NCT02307565.",2020,"Although higher SBP was associated with higher CBFv (p = 0.02), global cognitive function was not improved with midodrine.
","['Forty-one healthy hypotensive individuals with chronic (≥1-year post injury) SCI participated in this 2-day study', 'hypotensive patients with SCI', 'persons with SCI', 'Individuals with spinal cord injury (SCI) above T6 experience impaired descending cortical control of the autonomic nervous system, which predisposes them to hypotension', 'hypotensive individuals with SCI']","['midodrine or placebo', 'placebo', 'placebo, midodrine', 'midodrine']","['SBP', 'normalize systolic blood pressure (SBP', 'blood pressure', 'cerebral blood flow velocity (CBFv) and global cognitive function', 'global cognitive function', 'Seated SBP, CBFv, and cognitive performance']","[{'cui': 'C0857353', 'cui_str': 'Hypotensive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",41.0,0.222919,"Although higher SBP was associated with higher CBFv (p = 0.02), global cognitive function was not improved with midodrine.
","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Wecht', 'Affiliation': 'James J Peters VA Medical Center, Bronx, NY, USA. Jill.Wecht@va.gov.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Weir', 'Affiliation': 'University of Kansas, Lawrence, KS, USA.'}, {'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Katzelnick', 'Affiliation': 'James J Peters VA Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Weber', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'James J Peters VA Medical Center, Bronx, NY, USA.'}]",Spinal cord,['10.1038/s41393-020-0448-0']
409,32182680,Effects of Neuromuscular Training on Motor Competence and Physical Performance in Young Female Volleyball Players.,"Although neuromuscular training (NMT) emphasizes injury prevention training, there is little information about its effects on performance in young athletes. This study aimed to investigate the effects of eight-weeks NMT on motor competence and physical performance in 10- to 12-year-old female volleyball players. Sixty-six participants (mean ± SD; 11.05 ± 0.72 years) were randomized into either the NMT group (NTG; n = 32) or control group (CON; n = 34). Sprint on 10-m, modified T-test, plank, vertical jump, and medicine ball throw tests were used to assess the physical performance. The Körperkoordinationstest für Kinder (KTK) was used to assess the subjects' motor competence. The NMT was performed twice a week during the first 30 min of each regularly scheduled 90-minute volleyball training. Participants in the CON group attended only their regular volleyball training. A significant group x time interaction was found for Motor Quotient KTK (MQKTK) ( p  < 0.001), KTK lateral jumps ( p  < 0.001), and KTK shifting platforms ( p  < 0.01). There was a significant interaction for modified T-test results ( p  < 0.001) and vertical jump ( p  = 0.04). No change was observed in both groups for plank performance ( p  > 0.05). The NMT promoted significant gains in motor competence and physical performance in youth female volleyball players.",2020,There was a significant interaction for modified T-test results ( p  < 0.001) and vertical jump ( p  = 0.04).,"['10- to 12-year-old female volleyball players', 'Young Female Volleyball Players', 'Sixty-six participants (mean ± SD; 11.05 ± 0.72 years', 'young athletes', 'youth female volleyball players']","['CON', 'regular volleyball training', 'eight-weeks NMT', 'NMT', 'Neuromuscular Training', 'neuromuscular training (NMT']","['Motor Competence and Physical Performance', 'plank performance', 'motor competence and physical performance', 'Motor Quotient KTK (MQKTK']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517475', 'cui_str': '0.72'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C2607857'}]",66.0,0.0116458,There was a significant interaction for modified T-test results ( p  < 0.001) and vertical jump ( p  = 0.04).,"[{'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad 21000, Serbia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Department of Nephrology, University Medical Centre, Ljubljana 1000, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17051755']
410,31171725,Differential Gender Responses to an Empathy Component of a Sexual Assault Prevention Program.,"Although sexual assault (SA) prevention programs on college campuses are increasingly prevalent, no studies explore the influence of program components on outcomes. Empathy exercises are frequently included in such programs, with the intent of changing participant emotions and attitudes in order to change subsequent behavior. This study evaluated whether the inclusion of an empathy exercise within a SA prevention program impacted participants' emotions and attitudes, and subsequent helping behaviors in SA bystander situations. Three-hundred and seventy students (63% women) participated in an evaluation of a mandatory bystander intervention program; half the students received the program containing an empathy exercise and half received the program that did not. For women only, participation in the program with the empathy exercise led to more negative emotions and fewer attitudes condoning SA, the latter of which influenced greater prosocial bystander behaviors 6 months later.",2019,"For women only, participation in the program with the empathy exercise led to more negative emotions and fewer attitudes condoning SA, the latter of which influenced greater prosocial bystander behaviors 6 months later.",['Three-hundred and seventy students (63% women) participated in an evaluation of a mandatory bystander intervention program; half the students received the'],"['program containing an empathy exercise and half received the program that did not', 'empathy exercise within a SA prevention program']",['negative emotions'],"[{'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",370.0,0.0164118,"For women only, participation in the program with the empathy exercise led to more negative emotions and fewer attitudes condoning SA, the latter of which influenced greater prosocial bystander behaviors 6 months later.","[{'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Hines', 'Affiliation': 'Clark University, Department of Psychology, Worcester, MA.'}, {'ForeName': 'Lia R S', 'Initials': 'LRS', 'LastName': 'Bishop', 'Affiliation': 'Clark University, Department of Psychology, Worcester, MA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Palm Reed', 'Affiliation': 'Clark University, Department of Psychology, Worcester, MA.'}]",Violence and victims,['10.1891/0886-6708.VV-D-18-00046']
411,31077604,Dog ownership at three months of age is associated with protection against food allergy.,"BACKGROUND


The prevention of food allergy is a key priority for reducing the burden of allergic disease. Environmental exposures modulate the risk of developing food allergy and some of this may be mediated by the infants' developing microbiome. However, the role of potentially protective environmental exposures, such as pet ownership, is largely uninvestigated with respect to food allergy.
METHODS


We performed a secondary cohort analysis in the Enquiring About Tolerance (EAT) study, which enrolled 1303 three-month infants onto a randomized trial to prevent food allergy. A survey elicited domestic animal ownership and participants were examined for atopic dermatitis (AD) at enrolment. Sensitization to foods and aeroallergens were elicited by skin and serum testing at 3, 12 and 36 months. Food allergy status was determined by double-blind placebo-controlled food challenges between 1 and 3 years.
RESULTS


Food allergy was diagnosed amongst 6.1% (68/1124) of participants with complete data. No significant relationships were demonstrated between food allergy and caesarean delivery, infections or antibiotic exposure in early life. After adjusting for familial atopic disease, maternal dog/cat sensitization and participant AD, living with dogs was associated with a 90% reduction in the odds of infants developing food allergy (adjusted odds ratio (aOR) 0.10 (confidence interval (CI) 0.01-0.71), P = 0.02). None of the 49 infants living with at least two dogs developed food allergy, suggesting a dose-response relationship (each dog owned aOR 0.12 (CI 0.02-0.81), P = 0.03). No relationship was demonstrated between owning dogs or cats and the development of AD.
CONCLUSION


Dog ownership in infancy may prevent food allergy.",2019,"No significant relationships were demonstrated between food allergy and caesarean delivery, infections or antibiotic exposure in early life.","['49 infants living with at least two dogs developed food allergy, suggesting a dose-response relationship (each dog owned aOR 0.12']",[],"['Food allergy status', 'food allergy and caesarean delivery, infections or antibiotic exposure in early life']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C4517426', 'cui_str': '0.12 (qualifier value)'}]",[],"[{'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",1303.0,0.155197,"No significant relationships were demonstrated between food allergy and caesarean delivery, infections or antibiotic exposure in early life.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Marrs', 'Affiliation': ""Paediatric Allergy Department, Women and Children's Health, King's College London, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Logan', 'Affiliation': ""Paediatric Allergy Department, Women and Children's Health, King's College London, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Craven', 'Affiliation': ""Paediatric Allergy Department, Women and Children's Health, King's College London, London, UK.""}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': ""Paediatric Allergy Department, Women and Children's Health, King's College London, London, UK.""}, {'ForeName': 'W H A Irwin', 'Initials': 'WHAI', 'LastName': 'McLean', 'Affiliation': 'Division of Molecular Medicine, Centre for Dermatology and Genetic Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Lack', 'Affiliation': ""Paediatric Allergy Department, Women and Children's Health, King's College London, London, UK.""}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, King's College London and Guy's & St Thomas' Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Allergy,['10.1111/all.13868']
412,32402495,Non-suturing microvascular anastomosis in maxillofacial reconstruction- a comparative study.,"AIM


The aim of the study is to compare the advantages and disadvantages of non-suturing anastomotic methods over conventional microsuturing for microvascular venous anastomosis.
MATERIALS AND METHODS


All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study. Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study. The patients selected for the study were randomly allocated to five groups of different techniques of venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA)). Intraoperative anastomotic time, flap ischaemic time, patency and leakage were the parameters that were assessed for all five groups.
RESULTS


80 Patients were randomly allocated to five groups and each group comprised 16 patients. The mean ischaemic time and standard deviation of Group I and Group II were 256.19 ± 10.622 min and 255.19 ± 11.083 min, and for groups III, IV, and V were 193.38 ± 9.972 min, 139.06 ± 6.413 min, and 139.31 ± 6.364 min respectively (p < 0.001). Mean anastomotic time and standard deviation were 19.813 ± 1.5366 min in Group I and 20.281 ± 1.6514 min in Group II. The non-sutured anastomosis groups III, IV, and V showed a mean anastomotic time of 5.375 ± 0.9876 min, 4.175 ± 0.7664 min, and 3.856 ± 0.867 min respectively (p value < 0.001). In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030). In Groups I and II, 18.8% and 6.3 % of patients respectively had leakage, whereas all patients in Groups III, IV, V had no leakage from the anastomotic site (p value 0.119).
CONCLUSION


Based on the results of the study, non-suturing techniques should be preferred over microsuturing technique whenever appropriate for venous anastomosis.",2020,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","['Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study', 'All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study', '80 Patients']","['venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA']","['Mean anastomotic time and standard deviation', 'mean ischaemic time and standard deviation', 'mean anastomotic time', 'leakage', 'Intraoperative anastomotic time, flap ischaemic time, patency and leakage', 'delayed patency', 'immediate patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0450432', 'cui_str': 'Venous anastomosis'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C3665740', 'cui_str': 'Vascular anastomosis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",80.0,0.0156835,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","[{'ForeName': 'Surya Kiran', 'Initials': 'SK', 'LastName': 'Mudigonda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: mudigondasuryakiran@gmail.com.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Murugan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, 600077, India. Electronic address: drmsenthilmurugan@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Velavan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: drvelavan@gmail.com.'}, {'ForeName': 'Selvakumar', 'Initials': 'S', 'LastName': 'Thulasiraman', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: selvakumaromfs@gmail.com.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Krishna Kumar Raja', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: kksukanya@gmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.005']
413,32402496,Does platelet-rich fibrin increase stability of the maxilla following Le Fort I osteotomy? A single-blind clinical trial study.,"This single-blind clinical trial study aimed to assess the efficacy of platelet-rich fibrin (PRF) in increasing stability following Le Fort I osteotomy for maxillary advancement. Patients who underwent Le Fort I osteotomy for maxillary advancement were assigned randomly into two groups: in group 1 (the study group, n = 22) PRF was placed in the osteotomy sites following fixation, while no PRF was used in group 2 (the control group, n = 22). Lateral cephalograms obtained preoperatively (T0), immediately after surgery (T1), and 1 year after surgery (T2) were compared between the two groups, and the amount of relapse was determined. The amount of maxillary change (relapse) at the A point in relation to the x-axis was 0.45 ± 0.67 mm in group 1 and 1.86 ± 0.56 mm in group 2. There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001). The mean maxillary change (relapse) in relation to the y-axis was 0.77 ± 1.15 mm in group 1 and 2.25 ± 1.22 mm in group 2. Analysis of the data demonstrated a significant difference in mean relapse in relation to the y-axis between the two groups (p < 0.001). PRF may enhance the stability of the maxilla following Le Fort I osteotomy. Based on the results of this study the administration of PRF should be considered whenever possible.",2020,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"['I osteotomy for maxillary advancement', 'Patients who underwent Le Fort']","['PRF', 'platelet-rich fibrin (PRF', 'PRF was placed in the osteotomy sites following fixation, while no PRF']","['amount of maxillary change (relapse', 'mean relapse', 'mean maxillary change (relapse']","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.034354,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tabrizi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mirmohammad Sadeghi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Bakhshaei', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Bakhshaei.pedram@gmail.com.'}, {'ForeName': 'Birkan Taha', 'Initials': 'BT', 'LastName': 'Ozkan', 'Affiliation': 'Oral and Maxillofacial Surgery, Toros University, Institute of Health Science, Toros, Turkey.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.007']
414,32402504,"Response to Letter Regarding ""A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis"".",,2020,,['Patients With Knee Osteoarthritis'],['Low-Dose Extracorporeal Shockwave Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]",[],,0.046562,,"[{'ForeName': 'Zongye', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bangzhong', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Deparment of Radiology, Huashan Hospital, Fudan University, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.008']
415,32401967,Posterior Capsule Opacification after Cataract Surgery in Children Over Five Years of Age with Square-edge Hydrophobic versus Hydrophilic Acrylic Intraocular Lenses: A Prospective Randomized Study.,"OBJECTIVE


To compare the effects of hydrophobic and hydrophilic materials in square-edged acrylic intraocular lenses (IOLs) on the development of posterior capsule opacification (PCO) after pediatric cataract surgery.
METHODS


Patients were randomly assigned to group 1 (hydrophobic acrylic square-edged IOLs; 13 eyes) or group 2 (hydrophilic acrylic square-edged IOLs; 13 eyes). The study evaluated PCO rates using Evaluation of Posterior Capsule Opacification (EPCO) 2000 software at one, three, six and 12 months postoperatively. Postoperative measurements also included corrected distance visual acuity (CDVA), neodymium:yttrium-aluminum-garnet (Nd:YAG) capsulotomy and postoperative complications other than PCO.
RESULTS


Both groups had significant increases in PCO rates after one year. Comparison of the groups showed no significant differences in the EPCO scores at three (group 1, 0.007±0.016 vs group 2, 0.008±0.014; p=0.830), six (group 1, 0.062±0.103 vs group 2, 0.021±0.023; p=0.184), or twelve months postoperatively (group 1, 0.200±0.193 vs group 2, 0.192±0.138; p=0.902). We also found no significant group differences regarding the change (delta, Δ) in EPCO scores between three and six months (group 1, 0.055±0.09 vs group 2, 0.013±0.02; p=0.113) or between six and twelve months postoperatively (group 1, 0.139±0.14 vs group 2, 0.171±0.14; p=0.567). Twenty-three percent of patients required Nd:YAG capsulotomy at the twelve-month visit.
CONCLUSIONS


No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.",2020,No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.,"['posterior capsule opacification (PCO) after pediatric cataract surgery', 'Children', 'Patients']","['acrylic intraocular lenses (IOLs', 'hydrophobic and hydrophilic materials', 'hydrophobic acrylic square-edged IOLs; 13 eyes) or group 2 (hydrophilic acrylic square-edged IOLs', 'Hydrophilic Acrylic Intraocular Lenses']","['corrected distance visual acuity (CDVA), neodymium:yttrium-aluminum-garnet', 'PCO rates', 'EPCO scores']","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilic'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0547806,No differences in PCO rates were found between hydrophobic and hydrophilic acrylic square-edged IOLs in children between five and twelve years of age at one year of follow-up.,"[{'ForeName': 'Camila Ribeiro', 'Initials': 'CR', 'LastName': 'Koch', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Marcony R', 'Initials': 'MR', 'LastName': 'Santhiago', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Priscilla A', 'Initials': 'PA', 'LastName': 'Jorge', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sena', 'Affiliation': 'Hospital Humberto Castro Lima, Salvador, BA, BR.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Kara-Júnior', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1604']
416,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
417,31549935,"Predictors of Recurrence, and Progression-Free and Overall Survival following Open versus Robotic Radical Cystectomy: Analysis from the RAZOR Trial with a 3-Year Followup.","PURPOSE


The RAZOR (Randomized Open versus Robotic Cystectomy) trial revealed noninferior 2-year progression-free survival for robotic radical cystectomy. This update was performed with extended followup for 3 years to determine potential differences between the approaches. We also report 3-year overall survival and sought to identify factors predicting recurrence, and progression-free and overall survival.
MATERIALS AND METHODS


We analyzed the per protocol population of 302 patients from the RAZOR study. Cumulative recurrence was estimated using nonbladder cancer death as the competing risk event and the Gray test was applied to assess significance in differences. Progression-free survival and overall survival were estimated by the Kaplan-Meier method and compared with the log rank test. Predictors of outcomes were determined by Cox proportional hazard analysis.
RESULTS


Estimated progression-free survival at 36 months was 68.4% (95% CI 60.1-75.3) and 65.4% (95% CI 56.8-72.7) in the robotic and open groups, respectively (p=0.600). At 36 months overall survival was 73.9% (95% CI 65.5-80.5) and 68.5% (95% CI 59.8-75.7) in the robotic and open groups, respectively (p=0.334). There was no significant difference in the cumulative incidence rates of recurrence (p=0.802). Patient age greater than 70 years, poor performance status and major complications were significant predictors of 36-month progression-free survival. Stage and positive margins were significant predictors of recurrence, and progression-free and overall survival. Surgical approach was not a significant predictor of any outcome.
CONCLUSIONS


This analysis showed no difference in recurrence, 3-year progression-free survival or 3-year overall survival for robotic vs open radical cystectomy. It provides important prospective data on the oncologic efficacy of robotic radical cystectomy and high level data for patient counseling.",2020,"This analysis shows no difference in recurrence, 3-year PFS and 3-year OS between RARC and ORC.",['302 patients from RAZOR study was analyzed'],"['robotic cystectomy (RAZOR', 'robotic radical cystectomy (RARC', 'Open Versus Robotic Radical Cystectomy']","['Cumulative recurrences', '3-year overall survival (OS', 'cumulative incidence rates of recurrence', 'Recurrence, Progression-Free and Overall Survival', 'recurrence, PFS and OS', 'PFS and OS', 'recurrence, 3-year PFS and 3-year OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336670', 'cui_str': 'Razor, device (physical object)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0336670', 'cui_str': 'Razor, device (physical object)'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",302.0,0.29492,"This analysis shows no difference in recurrence, 3-year PFS and 3-year OS between RARC and ORC.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Venkatramani', 'Affiliation': 'Department of Urology, University of Miami, Miami, Florida.'}, {'ForeName': 'Isildinha M', 'Initials': 'IM', 'LastName': 'Reis', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Castle', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Gonzalgo', 'Affiliation': 'Department of Urology, University of Miami, Miami, Florida.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Woods', 'Affiliation': 'Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'Division of Urologic Oncology, Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alon Z', 'Initials': 'AZ', 'LastName': 'Weizer', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor,Michigan.'}, {'ForeName': 'Badrinath R', 'Initials': 'BR', 'LastName': 'Konety', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Tollefson', 'Affiliation': 'Department of Urology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Krupski', 'Affiliation': 'Department of Urology, University of Virginia Health Science Center, Charlottesville, Virginia.'}, {'ForeName': 'Norm D', 'Initials': 'ND', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Shabsigh', 'Affiliation': 'Department of Urology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Barocas', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Marcus L', 'Initials': 'ML', 'LastName': 'Quek', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Atreya', 'Initials': 'A', 'LastName': 'Dash', 'Affiliation': 'Department of Urology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Raj S', 'Initials': 'RS', 'LastName': 'Pruthi', 'Affiliation': 'Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Jeffrey Scott', 'Initials': 'JS', 'LastName': 'Montgomery', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor,Michigan.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weight', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Sharp', 'Affiliation': 'Department of Urology, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sam S', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Cookson', 'Affiliation': 'Department of Urology, Oklahoma University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Gopal N', 'Initials': 'GN', 'LastName': 'Gupta', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gorbonos', 'Affiliation': 'Department of Urology, Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Uchio', 'Affiliation': 'Department of Urology,University of California at Irvine, Irvine, California.'}, {'ForeName': 'Eila', 'Initials': 'E', 'LastName': 'Skinner', 'Affiliation': 'Department of Urology, Stanford University, Stanford, California.'}, {'ForeName': 'Nachiketh', 'Initials': 'N', 'LastName': 'Soodana-Prakash', 'Affiliation': 'Department of Urology, University of Miami, Miami, Florida.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Becerra', 'Affiliation': 'Department of Urology, University of Miami, Miami, Florida.'}, {'ForeName': 'Sanjaya', 'Initials': 'S', 'LastName': 'Swain', 'Affiliation': 'Department of Urology, University of Miami, Miami, Florida.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Kendrick', 'Affiliation': 'Division of Urologic Oncology, Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, Texas.'}, {'ForeName': 'Dipen J', 'Initials': 'DJ', 'LastName': 'Parekh', 'Affiliation': 'Department of Urology, University of Miami, Miami, Florida.'}]",The Journal of urology,['10.1097/JU.0000000000000565']
418,32404035,Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups.,"Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results- The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39-0.82]; interaction  P =0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43-0.94]; interaction  P =0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions- In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.",2020,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","['patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with', 'older patients', 'patients with embolic stroke of undetermined source', 'Patients With Embolic Stroke of Undetermined Source', '5390 patients from December 2014 to January 2018']","['Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid', 'aspirin 100 mg once daily', 'Methods- RE-SPECT ESUS', 'Aspirin', ' and Purpose', 'dabigatran versus aspirin', 'aspirin', 'Conclusions', 'dabigatran']","['Stroke rates', 'Risks for major bleeding', 'recurrent stroke', 'rates of recurrent stroke and major bleeding', 'rate of recurrent stroke', 'bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",5390.0,0.375563,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'From the Faculty of Medicine, Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Clinical and Translational Science, Miller School of Medicine, University of Miami, FL (R.L.S.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (C.B.G.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bar', 'Affiliation': 'Department of Neurology, University Hospital Ostrava, Ostrava-Poruba-Poruba, Czech Republic (M. Bar).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL (R.A.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brainin', 'Affiliation': 'Department of Neurosciences and Preventive Medicine, Danube University Krems, Krems an der Donau, Austria (M. Brainin).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Metabolism Medicine, Boehringer Ingelheim International GmbH, Germany (M. Brueckmann).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cronin', 'Affiliation': 'Cardiometabolic Medicine, Boehringer Ingelheim Ltd, Burlington, ON, Canada (L.C.).'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Donnan', 'Affiliation': 'Department of Neurology, Melbourne Brain Centre, University of Melbourne, Parkville, VIC, Australia (G.D.).'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Gdovinová', 'Affiliation': 'Department of Neurology, Pavol Jozef Šafárik University in Košice, University Hospital L. Pasteur, Košice, Slovak Republic (Z.G.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Clinical Operations Global, Boehringer Ingelheim Pharma GmbH & Co. K.G., Biberach, Germany (C.G.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany (E.K.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia (T.J.K.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lyrer', 'Affiliation': 'Division of Neurology, Stroke Center, University Hospital Basel, Switzerland (P.L.).'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Martins', 'Affiliation': 'Neurology Service, Hospital de Clínicas de Porto Alegre, Brazil (S.M.).'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Meyerhoff', 'Affiliation': 'Cardiology Medicine, Boehringer Ingelheim International GmbH, Germany (J.M.).'}, {'ForeName': 'Truman', 'Initials': 'T', 'LastName': 'Milling', 'Affiliation': 'Department of Neurology, Department of Surgery and Perioperative Care, Seton Dell Medical School Stroke Institute, Austin, TX (T.M.).'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Pfeilschifter', 'Affiliation': 'Center of Neurology and Neurosurgery, Goethe University Frankfurt, Frankfurt am Main, Germany (W.P.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Poli', 'Affiliation': 'Department of Neurology with Focus on Neurovascular Diseases and Neurooncology, University of Tübingen, and Hertie Institute for Clinical Brain Research, Germany (S.P.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Reif', 'Affiliation': 'Department of Neurology, Cerebrovaskulární ambulance s.r.o., Brno, Czech Republic (M.R.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Rose', 'Affiliation': 'Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa (D.Z.R.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Šaňák', 'Affiliation': 'Comprehensive Stroke Center, Department of Neurology, Palacky University, Olomouc, Czech Republic (D.S.).'}, {'ForeName': 'Wolf-Rüdiger', 'Initials': 'WR', 'LastName': 'Schäbitz', 'Affiliation': 'Department of Neurology, Evangelisches Klinikum Bethel, Bielefeld, Germany (W.-R.S.).'}]",Stroke,['10.1161/STROKEAHA.119.028643']
419,32401600,"Efficacy and safety of a booster dose of the meningococcal A, C, W, Y-tetanus toxoid conjugate vaccine administered 10 years after primary vaccination and long-term persistence of tetanus toxoid conjugate or polysaccharide vaccine.","A previous phase 3, randomized, multicenter study showed the immunogenicity of a primary vaccination of subjects aged 11 to 17 years with the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS). This extension study evaluated the safety and immunogenicity of a MenACWY-TT booster 10 years after receiving a primary dose of either MenACWY-TT or MenACWY-PS. The primary immunogenicity endpoint was booster response, evaluated using serum bactericidal antibody assays with rabbit complement (rSBA), 1 month postbooster. Safety endpoints included the percentage of subjects experiencing local and general adverse events (AEs) ≤4 days after MenACWY-TT booster. Of 229 subjects enrolled, 169 and 58 in the MenACWY-TT and MenACWY-PS groups, respectively, completed the booster phase. The 1 month postbooster response for each serogroup ranged from 81.5% to 95.7% for MenACWY-TT and 66.7% to 94.1% for MenACWY-PS. Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128. No new safety signals were observed during the booster phase. In conclusion, a MenACWY-TT booster dose after receiving either a primary dose of MenACWY-TT or MenACWY-PS elicited robust immune responses and was well tolerated. Functional antibody responses last up to 10 years after primary MenACWY-TT vaccination.",2020,"Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128.","['229 subjects enrolled, 169 and 58 in the MenACWY-TT and MenACWY-PS groups, respectively, completed the booster phase', 'subjects aged 11 to 17\xa0years with the']","['quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS', 'tetanus toxoid conjugate or polysaccharide vaccine', 'MenACWY-TT or MenACWY-PS']","['new safety signals', 'booster response, evaluated using serum bactericidal antibody assays with rabbit complement (rSBA), 1\xa0month postbooster', 'tolerated', 'Efficacy and safety', 'safety and immunogenicity', 'Functional antibody responses', 'percentage of subjects experiencing local and general adverse events (AEs']","[{'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C2936353', 'cui_str': 'Serum Bactericidal Antibody Assays'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",229.0,0.0353615,"Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128.","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Quiambao', 'Affiliation': 'Clinical Research Division, Research Institute for Tropical Medicine , Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Peyrani', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Cutler', 'Affiliation': 'Pfizer Vaccine Research and Development, Pfizer Inc , Pearl River, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van Der Wielen', 'Affiliation': 'Vaccines R & D, GlaxoSmithKline , Wavre, Belgium.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Hurley, UK.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1744363']
420,31977825,Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.,"BACKGROUND


Almost one-third of patients with proximal humeral fractures are treated surgically, and the number is increasing. When surgical treatment is chosen, there is sparse evidence on the optimum method. The DelPhi (Delta prosthesis-PHILOS plate) trial is a clinical trial comparing 2 surgical treatments. Our hypothesis was that reverse total shoulder arthroplasty (TSA) yields better clinical results compared with open reduction and internal fixation (ORIF) using an angular stable plate.
METHODS


The DelPhi trial is a randomized controlled trial comparing reverse TSA with ORIF for displaced proximal humeral fractures (OTA/AO types 11-B2 and 11-C2) in elderly patients (65 to 85 years of age). The primary outcome measure was the Constant score at a 2-year follow-up. The secondary outcome measures included the Oxford Shoulder Score and radiographic evaluation. Results were reported as the mean difference with 95% confidence interval (CI). The intention-to-treat principle was applied for crossover patients.
RESULTS


There were 124 patients included in the study. At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA. When stratified for fracture classification, the mean score was 69.3 points (95% CI, 63.9 to 74.7 points) for the reverse TSA group and 50.6 points (95% CI, 41.9 to 59.2 points) for the ORIF group for type-C2 fractures, which yielded a significant mean difference of 18.7 points (95% CI, 9.3 to 28.2 points; p < 0.001). In the type-B2 fracture group, the mean score was 66.2 points (95% CI, 58.6 to 73.8 points) for the reverse TSA group and 58.5 points (95% CI, 49.6 to 67.4 points) for the ORIF group, resulting in a nonsignificant mean difference of 7.6 points (95% CI, -3.8 to 19.1 points; p = 0.19).
CONCLUSIONS


At a 2-year follow-up, the data suggested an advantage of reverse TSA over ORIF in the treatment of displaced OTA/AO type-B2 and C2 proximal humeral fractures in elderly patients.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA.","['elderly patients (65 to 85 years of age', '124 patients included in the study', 'elderly patients', 'patients with proximal humeral fractures']","['Reverse Shoulder Arthroplasty Is Superior to Plate Fixation', 'TSA', 'TSA with ORIF']","['mean score', 'Constant score at a 2-year follow-up', 'Oxford Shoulder Score and radiographic evaluation', 'mean Constant score', 'internal fixation (ORIF', 'total shoulder arthroplasty ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0037006', 'cui_str': 'Humeral Fractures, Proximal'}]","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1872220', 'cui_str': '(125I)-TSA'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}]",124.0,0.228799,"At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA.","[{'ForeName': 'Alexander Nilsskog', 'Initials': 'AN', 'LastName': 'Fraser', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bjørdal', 'Affiliation': 'Department of Orthopedic Surgery, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Tone Mehlum', 'Initials': 'TM', 'LastName': 'Wagle', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anna Cecilia', 'Initials': 'AC', 'LastName': 'Karlberg', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Odd Arve', 'Initials': 'OA', 'LastName': 'Lien', 'Affiliation': 'Department of Orthopedic Surgery, Vestre Viken Hospital Trust, Bærum Hospital, Bærum, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eilertsen', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Mader', 'Affiliation': 'Division of Hand, Forearm and Elbow Traumatology, Department of Trauma, Hand and Reconstructive Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Apold', 'Affiliation': 'Department of Orthopedic Surgery, Telemark Hospital, Skien, Norway.'}, {'ForeName': 'Leif Børge', 'Initials': 'LB', 'LastName': 'Larsen', 'Affiliation': 'Department of Orthopedic Surgery, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Fjalestad', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01071']
421,31765046,Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study.,"BACKGROUND & AIMS


Hepatitis C virus (HCV) genotype (GT) 4 infection is prevalent in sub-Saharan Africa and the Middle East, particularly in Egypt. This study evaluated the safety and efficacy of elbasvir/grazoprevir administered for 8 and 12 weeks in participants with HCV GT4 infection.
METHODS


In this partially randomized, open-label multicentre study conducted in France (NCT03111108; Protocol MK5172-096), treatment-naive participants with GT4 infection and F0-F2 fibrosis were randomized 2:1 to elbasvir (50 mg)/grazoprevir (100 mg) for 8 or 12 weeks. Treatment-naive participants with F3-F4 fibrosis and all treatment-experienced participants (F0-F4) were assigned to elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response (SVR) 12 weeks after the end of therapy.
RESULTS


One hundred and seventeen participants were enrolled. Among treatment-naive participants with F0-F2 fibrosis, SVR was achieved by 94% (50/53) and 96% (26/27) of those receiving elbasvir/grazoprevir for 8 or 12 weeks, respectively, and four participants relapsed. In the 12-week arm, 95% (35/37) achieved SVR and two participants relapsed. NS5A resistance-associated substitutions were present at baseline and virologic failure in five of the participants with relapse. Drug-related adverse events occurred in 42% (n = 22) and 50% (n = 32) of participants receiving 8 and 12 weeks of treatment, respectively. No participant discontinued treatment owing to an adverse event.
CONCLUSION


These data confirm the efficacy of elbasvir/grazoprevir administered for 12 weeks in treatment-experienced individuals with HCV GT4 infection and those with advanced fibrosis. Treatment-naive individuals with mild fibrosis can be treated effectively with an 8-week regimen.",2020,NS5A resistance-associated substitutions were present at baseline and virologic failure in 5 of the participants with relapse.,"['Treatment-naive participants with F3-F4 fibrosis and all treatment-experienced participants (F0-F4', 'Treatment-naive individuals with mild fibrosis', 'participants with HCV genotype (GT)4 infection', '117 participants were enrolled', 'France (NCT03111108; Protocol MK5172-096), treatment-naive participants with GT4 infection and F0-F2 fibrosis', 'hepatitis C virus']","['elbasvir (50 mg)/grazoprevir', 'elbasvir/grazoprevir', 'Hepatitis C virus (HCV) genotype (GT']","['adverse events', 'virologic failure', 'Efficacy and safety', 'sustained virologic response (SVR', 'safety and efficacy', 'NS5A resistance-associated substitutions']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3660680', 'cui_str': 'MK5172'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}]","[{'cui': 'C4080052', 'cui_str': 'elbasvir'}, {'cui': 'C4080453', 'cui_str': 'elbasvir / grazoprevir'}, {'cui': 'C1533728', 'cui_str': 'Hepatitis C virus genotype'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",117.0,0.0536005,NS5A resistance-associated substitutions were present at baseline and virologic failure in 5 of the participants with relapse.,"[{'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Asselah', 'Affiliation': 'Department of Hepatology and Gastroenterology, University Paris Diderot, Sorbonne Paris Cité, CRI, UMR 1149 INSERM, Paris, France.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Pol', 'Affiliation': 'Department of Hepatology, APHP Hôpital Cochin/Université Paris Descartes/INSERM U1223, Institut Pasteur, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hezode', 'Affiliation': 'Department of Hepatology, Henri Mondor Hospital, APHP, University of Paris-Est, INSERM U955, Créteil, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Loustaud-Ratti', 'Affiliation': 'Department of Hepatology and Gastroenterology, CHU de Limoges, U850 INSERM, Université Limoges, Limoges, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Leroy', 'Affiliation': 'CHU de Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Si Nafa Si', 'Initials': 'SNS', 'LastName': 'Ahmed', 'Affiliation': 'Department of Hepatology and Gastroenterology, Pȏle de Recherche Clinique, Hôpital Saint Joseph, Marseille, France.'}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Ozenne', 'Affiliation': 'Department of Hepatology and Gastroenterology, Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bronowicki', 'Affiliation': 'Department of Hepatology and Gastroenterology, CHU de Nancy, Nancy, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Larrey', 'Affiliation': 'Department of Hepatology, Hôpital Saint Eloi, Ecole de Médecine de Montpellier, Montpellier, France.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': ""Department of Gastroenterology, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Alric', 'Affiliation': 'Department of Internal Medicine/Gastroenterology, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Nguyen-Khac', 'Affiliation': 'Department of Hepatology and Gastroenterology, CHU de Amiens, Amiens, France.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Robertson', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Asante-Appiah', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Feng-Hsiu', 'Initials': 'FH', 'LastName': 'Su', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Hwang', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Jessie Durrand', 'Initials': 'JD', 'LastName': 'Hall', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Guidoum', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hagen', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Haber', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Talwani', 'Affiliation': 'Department of Infectious Diseases, Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Serfaty', 'Affiliation': 'Department of Hepatology, Hôpital de Hautepierre, Universitaires de Strasbourg, Strasbourg, France.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14313']
422,32041897,Colocalized White Matter Plasticity and Increased Cerebral Blood Flow Mediate the Beneficial Effect of Cardiovascular Exercise on Long-Term Motor Learning.,"Cardiovascular exercise (CE) is a promising intervention strategy to facilitate cognition and motor learning in healthy and diseased populations of all ages. CE elevates humoral parameters, such as growth factors, and stimulates brain changes potentially relevant for learning and behavioral adaptations. However, the causal relationship between CE-induced brain changes and human's ability to learn remains unclear. We tested the hypothesis that CE elicits a positive effect on learning via alterations in brain structure (morphological changes of gray and white matter) and function (functional connectivity and cerebral blood flow in resting state). We conducted a randomized controlled trial with healthy male and female human participants to compare the effects of a 2 week CE intervention against a non-CE control group on subsequent learning of a challenging new motor task (dynamic balancing; DBT) over 6 consecutive weeks. We used multimodal neuroimaging [T1-weighted magnetic resonance imaging (MRI), diffusion-weighted MRI, perfusion-weighted MRI, and resting state functional MRI] to investigate the neural mechanisms mediating between CE and learning. As expected, subjects receiving CE subsequently learned the DBT at a higher rate. Using a modified nonparametric combination approach along with multiple mediator analysis, we show that this learning boost was conveyed by CE-induced increases in cerebral blood flow in frontal brain regions and changes in white matter microstructure in frontotemporal fiber tracts. Our study revealed neural mechanisms for the CE-learning link within the brain, probably allowing for a higher flexibility to adapt to highly novel environmental stimuli, such as learning a complex task. SIGNIFICANCE STATEMENT  It is established that cardiovascular exercise (CE) is an effective approach to promote learning and memory, yet little is known about the underlying neural transfer mechanisms through which CE acts on learning. We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a colocalized increase in cerebral blood flow. Our findings are among the first to demonstrate a transfer potential of experience-induced brain plasticity. In addition to practical implications for health professionals and coaches, our work paves the way for future studies investigating effects of CE in patients suffering from prefrontal hypoperfusion or white matter diseases.",2020,We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a co-localized increase in cerebral blood flow.,"['healthy and diseased populations of all ages', 'patients suffering from prefrontal hypoperfusion or white matter diseases', 'healthy, male and female human participants']","['CE intervention against a non-CE control group on subsequent learning of a challenging new motor task (dynamic balancing, DBT', 'Cardiovascular exercise (CE', 'Cardiovascular Exercise', 'CE', 'cardiovascular exercise (CE']","['learning via alterations in brain structure (morphological changes of gray and white matter) and function (functional connectivity and cerebral blood flow in resting state', 'cerebral blood flow', 'Cerebral Blood Flow Mediate']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion (qualifier value)'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0682708'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]",,0.0330105,We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a co-localized increase in cerebral blood flow.,"[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Lehmann', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany, nico1.lehmann@ovgu.de.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Villringer', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Taubert', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2310-19.2020']
423,32200533,Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia.,"INTRODUCTION


Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation (Lotriga ® , Takeda Pharmaceutical Company Limited), are approved in Japan to treat triglyceridemia. We investigated the effects of omega-3 on vascular endothelial function, measured by flow-mediated dilation (FMD).
METHODS


Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were randomized 1:1 to receive omega-3 at 2 g (QD) or 4 g (2 g BID) for 8 weeks. The primary end point was the change from baseline of fasting  %FMD in each treatment group. Secondary end points included the 4-h postprandial  %FMD and 4-h postprandial triglyceride (TG) level.
RESULTS


Thirty-seven patients were randomized to receive omega-3 at 2 g (n = 18) or 4 g (n = 19). Mean fasting %FMD did not increase from baseline to week 8 in the 2-g group (- 1.2%) or 4-g group (- 1.3%). Mean 4-h postprandial %FMD did not change from baseline to week 8 in the 2-g group (0.0%), but increased in the 4-g group (1.0%). Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001). No new safety concerns were identified.
CONCLUSIONS


Fasting %FMD did not improve after 8 weeks of omega-3 treatment at 2 g or 4 g. After 8 weeks, 4-h postprandial TG levels showed improvement at both doses, with a greater reduction in the 4-g group.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT02824432.",2020,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","['Patients With Hyperlipidemia', 'Thirty-seven patients', 'Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors']","['Omega-3 Fatty Acid Ethyl Esters', 'Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation', 'omega-3 at 2\xa0g']","['Mean 4-h postprandial TG level', '4-h postprandial \xa0%FMD and 4-h postprandial triglyceride (TG) level', 'Vascular Endothelial Function', 'Mean 4-h postprandial %FMD', 'change from baseline of fasting \xa0%FMD', 'Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood', '4-h postprandial TG levels', 'Mean fasting %FMD', 'vascular endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0061511', 'cui_str': 'glutaryl-coenzyme A'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}]",37.0,0.0642346,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","[{'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Teramoto', 'Affiliation': 'Teikyo Academic Research Center, Teikyo University, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suzaki', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan. yuki.suzaki@takeda.com.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Uemura', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01286-1']
424,31444692,Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors.,"Peripheral sensory stimulation augments post-stroke upper extremity rehabilitation outcomes. Most sensory stimulations interfere with natural hand tasks and the stimulation duration is limited. We developed TheraBracelet, low-level random-frequency vibration applied via a wristwatch, to enable stimulation during hand tasks and potentially extend stimulation durations. To determine safety of prolonged exposure to TheraBracelet. Single-site double-blind crossover randomized controlled trial. Chronic stroke survivors were instructed to wear a device on the affected wrist for > 8 h/day everyday for 2 months while coming to the laboratory weekly for evaluations, with a 2-week break between each month. The device applied vibration at 60% and 1% of the sensory threshold for the real and sham month, respectively. The order of the real and sham months was randomized/balanced. Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling. Device-related AE rates were compared between the real and sham month. Twenty-five participants completed the study. Six participants (24%) experienced mild AEs involving worsened sensory scores that may be related to the intervention with reasonable possibility. Two experienced them in the real stimulation month only, 3 in the sham month only, and 1 in both months. Therefore, less participants experienced device-related AEs in the real than sham month. Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing TheraBracelet with therapy for increasing neurorehabilitation outcomes are a logical next step. Trial registration: NCT03318341.",2020,"Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling.","['Stroke Survivors', 'Chronic stroke survivors', 'Twenty-five participants completed the study', 'chronic stroke survivors']",['Peripheral sensory stimulation'],"['worsened sensory scores', 'Device-related AE rates', 'worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}]",25.0,0.393901,"Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling.","[{'ForeName': 'Na Jin', 'Initials': 'NJ', 'LastName': 'Seo', 'Affiliation': 'Division of Occupational Therapy, Department of Health Professions, Department of Health Sciences and Research, Medical University of South Carolina (MUSC), Charleston, SC, USA. seon@musc.edu.'}, {'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Enders', 'Affiliation': 'TheraBracelet Inc., Louisville, KY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fortune', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Cain', 'Affiliation': 'Division of Occupational Therapy, Department of Health Professions, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Amanda A', 'Initials': 'AA', 'LastName': 'Vatinno', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Schuster', 'Affiliation': 'Department of Health Professions, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, MUSC, Charleston, SC, USA.'}, {'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Department of Health Sciences and Research, MUSC, Charleston, SC, USA.'}]",Translational stroke research,['10.1007/s12975-019-00724-9']
425,31470240,"Piloting a clinical laboratory method to evaluate the influence of potential modified risk tobacco products on smokers' quit-related motivation, choice, and behavior.","Research methods are needed that can predict whether the availability of potential modified risk tobacco products (MRTPs) may influence smokers' quit-related motivation, choice, and behavior. This pilot study assessed the primary outcomes of feasibility and adherence to address this need using an electronic cigarette (ECIG) as a model MRTP. Cigarette smokers were randomly assigned to use only their own brand of cigarettes (OB-only) or a second-generation ECIG (18 ng/ml nicotine) plus their OB cigarettes (ECIG+OB) ad libitum for four weeks. Participants logged products using a mobile device, collected used cigarette filters, and provided saliva samples every day for analysis of cotinine. They returned to the lab once per week to provide a breath sample and accept or decline a choice to quit all tobacco products (i.e., cigarettes and/or ECIGs). They also returned for a one-month follow-up visit. Of those participants randomized (n = 60), 56.7% completed the 4-week intervention and 40.0% completed the follow-up visit. The primary reason for withdrawal was poor adherence with mobile device use. Comparable numbers of participants in each group chose to make a quit attempt, although more OB-only participants chose to quit during the first two weeks and more ECIG+OB participants during the last two weeks. With protocol modifications to reduce participation burden, the current method might ultimately be used by regulators to predict how smokers' quit-related motivation, choice, and behavior are influenced by current and future MRTPs.",2019,"Comparable numbers of participants in each group chose to make a quit attempt, although more OB-only participants chose to quit during the first two weeks and more ECIG+OB participants during the last two weeks.",['Cigarette smokers'],"['electronic cigarette (ECIG', 'cigarettes (OB-only) or a second-generation ECIG (18\u202fng/ml nicotine) plus their OB cigarettes (ECIG+OB) ad libitum']","[""smokers' quit-related motivation, choice, and behavior""]","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0640915,"Comparable numbers of participants in each group chose to make a quit attempt, although more OB-only participants chose to quit during the first two weeks and more ECIG+OB participants during the last two weeks.","[{'ForeName': 'Jenny E', 'Initials': 'JE', 'LastName': 'Ozga-Hess', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Felicione', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Geri', 'Initials': 'G', 'LastName': 'Dino', 'Affiliation': 'WV Prevention Research Center, West Virginia University, Morgantown, WV, USA; Department of Social and Behavioral Sciences, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Elswick', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Whitworth', 'Affiliation': 'WV Prevention Research Center, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turiano', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Blank', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA. Electronic address: Melissa.Blank@mail.wvu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106105']
426,31526218,"A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants.","Objectives : To assess the safety and reactogenicity of single oral dose of heat-stable rotavirus vaccine (HSRV) in healthy adults aged 18-45 years followed by assessment of safety, reactogenicity, and immunogenicity of three doses of HSRV in healthy infants aged 6-8 weeks at enrollment. Trial Design : Single-center randomized controlled, sequential, blinded (adults) and open-label (infants). Setting : Single site at International Center for Diarrheal Disease Research, Bangladesh (icddr,b). Participants : Fifty eligible adults randomized in 1:1 ratio (HSRV: Placebo) followed by 50 eligible infants randomized in 1:1 ratio (HSRV: Comparator (RotaTeq®, pentavalent human-bovine (WC3) reassortant live-attenuated, rotavirus vaccine)). Intervention : Adults received either a single dose of HSRV or placebo and followed for 14 days. Infants received three doses of either HSRV or comparator with a follow-up for 28 days after each dose. Main Outcome Measures : Solicited and unsolicited adverse events (AEs) along with any serious adverse events (SAEs) were part of the safety and reactogenicity assessment in adults and infants whereas serum anti-rotavirus IgA response rates were part of immunogenicity assessment in infants only. Post-vaccination fecal shedding of vaccine-virus rotavirus strains was also determined in adults and infants. Results : In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults. In infants, HSRV had a safety profile similar to comparator vis-à-vis solicited AEs. In infants, fecal shedding of vaccine-virus strains was not detected in HSRV recipients but was observed in two comparator recipients. Percentage of infants exhibiting threefold rise in serum anti-rotavirus IgA titers from baseline to 1-month post-dose 3 in HSRV group was 88% (22/25) and 84% (21/25) in comparator group. Conclusion : HSRV was found to be generally well-tolerated in both adults and infants and immunogenic in infants.",2020,"In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults.","['adults and infants', 'Adults', 'infants', 'Participants:  Fifty eligible adults randomized in 1:1', 'adults and infants and immunogenic in infants', 'healthy adults aged 18-45 years', 'healthy adults', 'healthy infants aged 6-8 weeks at enrollment']","['ratio (HSRV: Placebo', 'vaccine-virus rotavirus strains', 'HSRV or placebo', 'placebo', 'HSRV', 'ratio (HSRV: Comparator (RotaTeq®, pentavalent human-bovine (WC3) reassortant live-attenuated, rotavirus vaccine', 'heat stable rotavirus vaccine (HSRV', 'heat-stable rotavirus vaccine']","['safety and reactogenicity assessment', 'solicited adverse events', 'Solicited and unsolicited adverse events (AEs) along with any serious adverse events (SAEs', 'safety, reactogenicity and immunogenicity', 'safety and reactogenicity', 'fecal shedding of vaccine-virus strains', 'serum anti-rotavirus IgA titers', 'serum anti-rotavirus IgA response rates', 'safety, reactogenicity, and immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C1528013', 'cui_str': 'RotaTeq'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",50.0,0.403958,"In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults.","[{'ForeName': 'Vibhu', 'Initials': 'V', 'LastName': 'Kanchan', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Asma Binte', 'Initials': 'AB', 'LastName': 'Aziz', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Sheikh Farzana', 'Initials': 'SF', 'LastName': 'Zaman', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Zaman', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Haque', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Mahbuba', 'Initials': 'M', 'LastName': 'Khanam', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Mahbubul', 'Initials': 'MM', 'LastName': 'Karim', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Kale', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Syed Khalid', 'Initials': 'SK', 'LastName': 'Ali', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Goveia', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Davinder', 'Initials': 'D', 'LastName': 'Gill', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'Wasif Ali', 'Initials': 'WA', 'LastName': 'Khan', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}, {'ForeName': 'Ajitpal', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'icddr, Dhaka, Bangladesh.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1664239']
427,31526225,"Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial.","Vaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 - 7.7] vs. 3.4 [95% CI: 2.7 - 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 - 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies.",2020,"Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3.","['pregnant women and their infants', 'pregnant women and indirect protection to their infants', 'Participants aged ≥18 years at weeks 20 to 32 of gestation', 'pregnant women']","['Trivalent inactivated influenza vaccines (IIV3s', 'quadrivalent inactivated influenza vaccine']","['Rates of solicited and unsolicited vaccine-related adverse events', 'hemagglutination inhibition (HAI) antibody titers', 'HAI antibody titers', 'Immunogenicity and safety', 'HAI titers', 'immunogenicity and safety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.234689,"Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Vaccine Research Center, Tampere University, Tampere, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Virta', 'Affiliation': 'Tampere Vaccine Research Clinic, Vaccine Research Center, Tampere University, Tampere, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Heinonen', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Eymin', 'Affiliation': 'Medical Operations, Sanofi Pasteur, Campus Sanofi Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Lavis', 'Affiliation': 'Medical Operations, Sanofi Pasteur, Campus Sanofi Lyon, Lyon, France.'}, {'ForeName': 'Anne Laure', 'Initials': 'AL', 'LastName': 'Chabanon', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Lyon, France.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Gresset-Bourgeois', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Lyon, France.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1667202']
428,32171600,Effect of Preoperative Intramuscular Injection of Botulinum Toxin A on Pain and Mouth Opening After Surgical Intervention in Temporomandibular Joint Ankylosis Cases: A Controlled Clinical Trial.,"PURPOSE


The aim of the present study was to determine the effect of intramuscular injection of botulinum toxin A (BTX-A) into the masticatory muscles on the physiotherapy pain and mouth opening outcomes after surgical intervention of temporomandibular joint (TMJ) ankylosis and to verify the effects using electromyographic studies.
PATIENTS AND METHODS


The study included 20 patients with TMJ ankylosis. The patients were further subdivided into control and interventional groups. The interventional group was given intramuscular injections of BTX-A in the masticator muscles before surgery. Only saline injections were given to the control group. All 20 patients were evaluated for pain and ease of active physiotherapy at the 1-week and 1-, 3-, and 6-month follow-up visits using a questionnaire. Intergroup comparisons were performed for both groups. Electromyographic (EMG) studies were also performed in the intervention group for each patient. EMG recordings were performed of the individual masticator muscle in each patient before injection and at 1 and 3 months after injection.
RESULTS


The intervention group showed better results with respect to pain during the mouth opening exercises and improvements in mouth opening. All the interventional group patients showed a transient decrease in the microvolt value on the EMG studies of their masticator muscles on injection of BTX-A.
CONCLUSIONS


BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.",2020,BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.,"['20 patients with TMJ ankylosis', 'Temporomandibular Joint Ankylosis Cases']","['botulinum toxin A (BTX-A', 'Botulinum Toxin A']","['Pain and Mouth Opening', 'pain and ease of active physiotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",20.0,0.0250176,BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.,"[{'ForeName': 'Saatvik', 'Initials': 'S', 'LastName': 'Shandilya', 'Affiliation': 'Postgraduate Student, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India. Electronic address: drsujatam@hotmail.com.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Chaudhary', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Sanchaita', 'Initials': 'S', 'LastName': 'Kohli', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Rudra Deo', 'Initials': 'RD', 'LastName': 'Kumar', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.011']
429,32059579,Comparison of the Effect of Different Resistance Training Frequencies on Phase Angle and Handgrip Strength in Obese Women: a Randomized Controlled Trial.,"Phase angle (PA) is a strong predictor of sarcopenia, fragility, and risk of mortality in obese people, while an optimal muscular function and handgrip strength (HS) are required to perform different daily activities. Although there is a general agreement that resistance training improves health status in obese people, the optimal weekly training frequency forPA and physical performance parameters is not clear.This study aimed to compare the effects of different weekly resistance training frequencies performed over a 24week exercise program on PA and HSin obese people. Forty-two women (56.2 ± 9.1 years, body mass index (BMI) 37.1 ± 4.9 kg/m 2 ) were randomly allocatedto one of two groups: a group with a highweekly training frequency of three times a week (HIGH, n= 21) and a group that performed only one weekly session (LOW, n= 21). The groups trained with an identical exercise intensity and volume per session for 6 months. Before and after the intervention period, the participants were assessed for anthropometric measures, bioimpedance analysis, and HS. There was a significant group × time interaction ( p <0.05) for waist circumference, bioimpedance reactance divided by body height (Xc/H), PA, and HS measures. In addition, only the HIGH group increased Xc/H, PA, and HS after the intervention period ( p <0.05), even after adjusting for weight loss and menopausal status. Physical exercise performed three times a week promotes better adaptations in PA and HSwhen compared with the same program performed once a week in obese women.",2020,"There was a significant group × time interaction ( p <0.05) for waist circumference, bioimpedance reactance divided by body height (Xc/H), PA, and HS measures.","['Forty-two women (56.2 ± 9.1 years, body mass index (BMI) 37.1 ± 4.9 kg/m 2 ', 'obese women', 'PA and HSin obese people', 'Obese Women', 'obese people']","['Physical exercise', '24week exercise program', 'Different Resistance Training Frequencies', 'resistance training']","['weight loss and menopausal status', 'health status', 'time interaction', 'waist circumference, bioimpedance reactance divided by body height (Xc/H), PA, and HS measures', 'Xc/H, PA, and HS']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",42.0,0.032957,"There was a significant group × time interaction ( p <0.05) for waist circumference, bioimpedance reactance divided by body height (Xc/H), PA, and HS measures.","[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Georgian', 'Initials': 'G', 'LastName': 'Badicu', 'Affiliation': 'Department of Physical Education and Special Motricity, University Transilvania of Brasov,500068 Brasov,Romania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bragonzoni', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Spiga', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mazzuca', 'Affiliation': 'Unit of Internal Medicine, Diabetes and Metabolic Disease Center, Romagna Health District, 47921 Rimini, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Campa', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, 40126 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17041163']
430,32070034,A Cost and Cost-Benefit Analysis of the Stand More AT Work (SMArT Work) Intervention.,"This study conducted a cost and cost-benefit analysis of the Stand More AT (SMArT) Work workplace intervention, designed to reduce sitting time. The study was a cluster two-armed randomised controlled trial involving 37 office clusters (146 desk-based workers) in a National Health Service Trust. The intervention group received a height-adjustable workstation with supporting behaviour change strategies. The control group continued with usual practice. Self-report absenteeism, presenteeism and work productivity were assessed at baseline, 3, 6 and 12 months; and organisational sickness absence records 12 months prior to, and 12 months of the intervention. Mean per employee costs associated with SMArT Work were calculated. Absenteeism, presenteeism and work productivity were estimated, and employer-recorded absence data and employee wage-banding were used to provide a human-capital-based estimate of costs to the organisation. The return-on-investment (ROI) and incremental cost-efficacy ratios (ICER) were calculated. Intervention cost was £692.40 per employee. Cost-benefit estimates show a net saving of £1770.32 (95%CI £-354.40, £3895.04) per employee as a result of productivity increase. There were no significant differences in absence data compared to the control group. SMArT Work provides supporting evidence for policy-makers and employers on the cost benefits of reducing sitting time at work.",2020,There were no significant differences in absence data compared to the control group.,['37 office clusters (146 desk-based workers) in a National Health Service Trust'],['height-adjustable workstation with supporting behaviour change strategies'],"['sitting time', 'Absenteeism, presenteeism and work productivity', 'Self-report absenteeism, presenteeism and work productivity', 'return-on-investment (ROI) and incremental cost-efficacy ratios (ICER']","[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C1736830', 'cui_str': 'Workstation (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",37.0,0.0317391,There were no significant differences in absence data compared to the control group.,"[{'ForeName': 'Fehmidah', 'Initials': 'F', 'LastName': 'Munir', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Miller', 'Affiliation': 'Miller Economics Ltd., Biohub Alderley Park, Alderley Edge SK10 4TG, UK.'}, {'ForeName': 'Stuart J H', 'Initials': 'SJH', 'LastName': 'Biddle', 'Affiliation': 'Institute for Resilient Regions, University of Southern Queensland, Education City, Springfield Central, QLD 4300, Australia.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester LE5 4PW, UK.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Esliger', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough LE11 3TU, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester LE1 7RH, UK.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': ""O'Connell"", 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester, Leicester General Hospital, Leicester LE5 4PW, UK.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Waheed', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester LE5 4PW, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester LE5 4PW, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester LE5 4PW, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17041214']
431,31565796,Aerobic interval training in standard treatment of out-patients with schizophrenia: a randomized controlled trial.,"OBJECTIVE


To evaluate the feasibility and effects of integrating aerobic interval training (AIT) in standard care of out-patients with schizophrenia on aerobic capacity and conventional cardiovascular disease (CVD) risk factors.
METHODS


Out-patients with schizophrenia spectrum disorder were randomized to the following: 1) a training group (TG), performing AIT 2 day/week at the clinic with adherence support from municipal services; or 2) a control group (CG), given two AIT sessions and encouraged to exercise on their own. Feasibility was assessed through retention/adherence.    V   ˙   O   2   peak        was measured directly along with conventional CVD risk factors before and after 12 weeks.
RESULTS


Of 48 out-patients, 16/25 and 18/23 completed the TG and CG respectively. After 12 weeks,    V   ˙   O   2   peak        was higher (2.7 ± 4.8 ml/kg/min, P < 0.01) in the TG compared with the CG. The TG improved    V   ˙   O   2   peak        by 3.1 ± 3.7 ml/kg/min (P < 0.01), while no change in the CG was observed. No intergroup difference in weight, body mass index (BMI), waist circumference, blood pressure, lipids, or glucose at posttest was observed. Weight (1.9 ± 4.0 kg, P < 0.05) and BMI (0.5 ± 1.1 kg/m 2  , P < 0.05) increased in the CG, with no change in the TG.
CONCLUSION


AIT, combined with adherence support, of out-patients with schizophrenia was feasible, improved    V   ˙   O   2   peak        , and may be integrated in standard care. (ClinicalTrials.gov identifier: NCT02743143).",2019,"The TG improved V̇O 2peak  by 3.1±3.7 mL·kg -1  ·min -1  (p<0.01), while no change in the CG was observed.","['Outpatients with schizophrenia spectrum disorder', 'outpatients with schizophrenia on aerobic capacity and conventional cardiovascular disease (CVD) risk factors', 'outpatients with schizophrenia']","['Aerobic interval training', 'training group (TG), performing AIT 2 d·wk -1  at the clinic with adherence support from municipal services; or 2) a control group (CG), given two AIT sessions, and encouraged to exercise on their own', 'integrating aerobic interval training (AIT']","['TG improved V̇O 2peak', 'Weight', 'weight, body mass index (BMI), waist circumference, blood pressure, lipids or glucose at posttest', 'V̇O 2peak', 'BMI']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",48.0,0.0584712,"The TG improved V̇O 2peak  by 3.1±3.7 mL·kg -1  ·min -1  (p<0.01), while no change in the CG was observed.","[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Brobakken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nygård', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Güzey', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Morken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Heggelund', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vedul-Kjelsaas', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13105']
432,32194098,Effects of a lifestyle intervention on cardiovascular risk among high-risk individuals for diabetes in a low- and middle-income setting: Secondary analysis of the Kerala Diabetes Prevention Program.,"We aimed to examine whether a lifestyle intervention was effective in reducing cardiovascular disease (CVD) risk in individuals at high-risk of developing diabetes in a low- and middle-income setting. The Kerala Diabetes Prevention Program was evaluated by a cluster-randomized controlled trial (2013-2016) of 1007 individuals (aged 30-60 years) at high-risk for diabetes (Indian Diabetes Risk Score ≥ 60 and without diabetes) in Kerala state, India. Sixty polling areas in Kerala were randomized to intervention or control groups by an independent statistician using a computer-generated randomization sequence. Participants from 30 intervention communities received a 12-month structured peer-support lifestyle intervention program involving 15 group sessions and linked community activities, aimed at supporting and maintaining lifestyle change. The primary outcome for this analysis was the predicted 10-year CVD risk at two years, assessed using the Framingham Risk Score. The mean age at baseline was 46.0 (SD: 7.5) years, and 47.2% were women. Baseline 10-year CVD risk was similar between study groups. The follow-up rate at two years was 95.7%. The absolute risk reduction in predicted 10-year CVD risk between study groups was 0.69% (95% CI: 0.09% to 1.29%, p=0.024) at one year and 0.69% (95% CI: 0.10% to 1.29%, p=0.023) at two years. The favorable change in CVD risk with the intervention condition was mainly due to the reduction in tobacco use (change index: -0.25, 95% CI: -0.42 to -0.09). Our findings suggest that a community-based peer-support lifestyle intervention could reduce CVD risk in individuals at high-risk of developing diabetes in India. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909.",2020,"The absolute risk reduction in predicted 10-year CVD risk between study groups was 0.69% (95% CI: 0.09% to 1.29%, p=0.024) at one year and 0.69% (95% CI: 0.10% to 1.29%, p=0.023) at two years.","['1007 individuals (aged 30-60\u202fyears) at high-risk for diabetes (Indian Diabetes Risk Score\u202f≥\u202f60 and without diabetes) in Kerala state, India', 'Sixty polling areas in Kerala', 'The mean age at baseline was 46.0 (SD: 7.5) years, and 47.2% were women', 'high-risk individuals for diabetes in a low- and middle-income setting', 'Participants from 30 intervention communities received a 12-month', 'individuals at high-risk of developing diabetes in a low- and middle-income setting']","['structured peer-support lifestyle intervention program involving 15 group sessions and linked community activities, aimed at supporting and maintaining lifestyle change', 'lifestyle intervention', 'community-based peer-support lifestyle intervention']","['predicted 10-year CVD risk', 'Baseline 10-year CVD risk', 'CVD risk', 'cardiovascular disease (CVD) risk', 'Framingham Risk Score', 'cardiovascular risk', '10-year CVD risk']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443018', 'cui_str': 'Kerala (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0862494,"The absolute risk reduction in predicted 10-year CVD risk between study groups was 0.69% (95% CI: 0.09% to 1.29%, p=0.024) at one year and 0.69% (95% CI: 0.10% to 1.29%, p=0.023) at two years.","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Lotfaliany', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia.'}, {'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; Population Health Research Institute, McMaster University, Hamilton, Canada. Electronic address: speaktosat@gmail.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; Centre for Online Health, Centre for Health Services Research, University of Queensland, Australia.'}, {'ForeName': 'Robyn Jennifer', 'Initials': 'RJ', 'LastName': 'Tapp', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; School of Biomedical Engineering and Imaging Sciences, Kings College London, United Kingdom.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Kapoor', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, India.'}, {'ForeName': 'Kavumpurathu Raman', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, India; Department of Public Health and Community Medicine, Central University of Kerala, Kasaragod, Kerala, India.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Australia; WHO Collaborating Centre on Implementation Research for Prevention & Control of NCDs, University of Melbourne, Australia.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106068']
433,31932751,"Comment on ""The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial"".",,2020,,['breast cancer diagnosis'],[],[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],[],,0.0644401,,"[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Bail', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB), Webb 601, 1675 University Boulevard, Birmingham, AL, 35294-3300, USA. jbail@uab.edu.'}, {'ForeName': 'Karina I', 'Initials': 'KI', 'LastName': 'Halilova', 'Affiliation': 'Division of Preventive Medicine, UAB, Birmingham, AL, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB), Webb 601, 1675 University Boulevard, Birmingham, AL, 35294-3300, USA.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Reeves', 'Affiliation': 'School of Public Health, The University of Queensland, Herston, QLD, Australia.'}]",British journal of cancer,['10.1038/s41416-019-0714-0']
434,32186940,Intravitreal Conbercept Injection as an Adjuvant in Vitrectomy with Silicone Oil Infusion for Severe Proliferative Diabetic Retinopathy.,"Purpose:  To assess the clinical effects of preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR).  Methods:  Ninety-eight eyes of 98 severe PDR patients undergoing vitrectomy with silicone oil tamponade were randomly assigned to 3 groups: Group 1 (34 eyes) received IVC injections 3 to 5 days before surgery; Group 2 (35 eyes) received IVC injections at the end of surgery; and Group 3 (29 eyes) received IVC injections 3 to 5 days before and at the end of operation. Follow-up examinations were performed for 6 months.  Results:  The incidence and severity of intraoperative bleeding were not significantly different ( P  = 0.233). However, the duration of surgery was significantly shorter in Group 1 and Group 3 compared with Group 2 ( P  < 0.001). The incidences of early and late recurrent vitreous hemorrhage (VH) were 32.35%, 28.57%, and 13.80%, respectively. At 6-month follow-up, mean best-corrected visual acuity had significantly increased to 1.25 ± 0.45 logMAR in Group 1, 1.29 ± 0.46 logMAR in Group 2, 1.16 ± 0.44 logMAR in Group 3 (all  P  < 0.001). The incidence of postoperative VH, neovascular glaucoma, and retinal detachment in Group 3 was slightly lower, however, no significant differences were observed (all  P  > 0.05). In young patients, similar results were observed and Group 3 had better visual improvements ( P  = 0.037).  Conclusions:  Preoperative IVC injection could be a safe and effective adjunct in pars plana vitrectomy with silicone oil tamponade for severe PDR. Preoperative combined with intraoperative IVC are promising, especially in young patients.",2020,"In young patients, similar results were observed and Group 3 had better visual improvements ( P  = 0.037).  ","['young patients', 'severe proliferative diabetic retinopathy (PDR', 'Ninety-eight eyes of 98 severe PDR patients undergoing', 'Severe Proliferative Diabetic Retinopathy']","['vitrectomy with silicone oil tamponade', 'Intravitreal Conbercept Injection', 'preoperative, intraoperative, or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in vitrectomy with silicone oil tamponade', 'Preoperative combined with intraoperative IVC', 'IVC injections', 'Silicone Oil Infusion']","['mean best-corrected visual acuity', 'visual improvements', 'incidence of postoperative VH, neovascular glaucoma, and retinal detachment', 'incidence and severity of intraoperative bleeding', 'incidences of early and late recurrent vitreous hemorrhage (VH', 'duration of surgery']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0037111', 'cui_str': 'Silicone Oils'}, {'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0017609', 'cui_str': 'Glaucoma, Neovascular'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",98.0,0.029451,"In young patients, similar results were observed and Group 3 had better visual improvements ( P  = 0.037).  ","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhongjing', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jili', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Shibei Hospital of Jingan District, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Department of Ophthalmology, Ruijin Hospital Affiliated Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0149']
435,31919136,Predictive Blood-Based Biomarkers in Patients with Epithelial Ovarian Cancer Treated with Carboplatin and Paclitaxel with or without Bevacizumab: Results from GOG-0218.,"PURPOSE


GOG-0218, a double-blind placebo-controlled phase III trial, compared carboplatin and paclitaxel with placebo, bevacizumab followed by placebo, or bevacizumab followed by bevacizumab in advanced epithelial ovarian cancer (EOC). Results demonstrated significantly improved progression-free survival (PFS), but no overall survival (OS) benefit with bevacizumab. Blood samples were collected for biomarker analyses.
EXPERIMENTAL DESIGN


Plasma samples were analyzed via multiplex ELISA technology for seven prespecified biomarkers [IL6, Ang-2, osteopontin (OPN), stromal cell-derived factor-1 (SDF-1), VEGF-D, IL6 receptor (IL6R), and GP130]. The predictive value of each biomarker with respect to PFS and OS was assessed using a protein marker by treatment interaction term within the framework of a Cox proportional hazards model. Prognostic markers were identified using Cox models adjusted for baseline covariates.
RESULTS


Baseline samples were available from 751 patients. According to our prespecified analysis plan, IL6 was predictive of a therapeutic advantage with bevacizumab for PFS ( P  = 0.007) and OS ( P  = 0.003). IL6 and OPN were found to be negative prognostic markers for both PFS and OS ( P  < 0.001). Patients with high median IL6 levels (dichotomized at the median) treated with bevacizumab had longer PFS (14.2 vs. 8.7 months) and OS (39.6 vs. 33.1 months) compared with placebo.
CONCLUSIONS


The inflammatory cytokine IL6 may be predictive of therapeutic benefit from bevacizumab when combined with carboplatin and paclitaxel. Aligning with results observed in patients with renal cancer treated with antiangiogenic therapies, it appears plasma IL6 may also define those patients with EOC more or less likely to benefit from the addition of bevacizumab to standard chemotherapy.",2020,IL6 and OPN were found to be negative prognostic markers for both PFS and OS (p<0.001).,"['renal cancer patients', 'advanced epithelial ovarian cancer (EOC', 'epithelial ovarian cancer patients treated with']","['carboplatin and paclitaxel with placebo, bevacizumab followed by placebo, or bevacizumab followed by bevacizumab', 'placebo', 'bevacizumab', 'carboplatin and paclitaxel with or without bevacizumab', 'carboplatin and paclitaxel']","['median IL6 levels', 'overall survival (OS) benefit', 'longer PFS', 'biomarkers (IL6, Ang-2, osteopontin (OPN), stromal cell-derived factor-1 (SDF-1), VEGF-D, IL6 receptor (IL6R), and GP130', 'progression-free survival (PFS', 'IL6 and OPN']","[{'cui': 'C0740457', 'cui_str': 'Cancer of Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}, {'cui': 'C0218504', 'cui_str': 'Chemokine (C-X-C Motif) Ligand 12'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",751.0,0.218524,IL6 and OPN were found to be negative prognostic markers for both PFS and OS (p<0.001).,"[{'ForeName': 'Angeles', 'Initials': 'A', 'LastName': 'Alvarez Secord', 'Affiliation': 'Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bell Burdett', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tritchler', 'Affiliation': 'GOG Statistical and Data Center, Buffalo, New York.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Sibley', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Starr', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'J Chris', 'Initials': 'JC', 'LastName': 'Brady', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': ""Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Herbert I', 'Initials': 'HI', 'LastName': 'Hurwitz', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'Division of Gynecology Oncology, Stephenson Cancer Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'Division of Gynecology Oncology, University of California Irvine Medical Center, Orange, California.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Gray', 'Affiliation': 'Division of Gynecology Oncology, Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jamie N', 'Initials': 'JN', 'LastName': 'Bakkum-Gamez', 'Affiliation': 'Division of Gynecology Oncology, Mayo Clinic, Byron, Minnesota.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Saitama Medical University International Medical Center, Hidaka, Japan.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Boente', 'Affiliation': 'Minnesota Oncology, Minneapolis, Minnesota.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'GOG Statistical and Data Center, Buffalo, New York.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'Division of Gynecologic Medical Oncology, Massachusetts General Hospital/Dana Farber Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina. anixon@duke.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0226']
436,32183608,Effects of an Iodine-Containing Prenatal Multiple Micronutrient on Maternal and Infant Iodine Status and Thyroid Function: A Randomized Trial in The Gambia.,"Background:  Iodine supplementation is recommended to pregnant women in iodine-deficient populations, but the impact in moderate iodine deficiency is uncertain. We assessed the effect of an iodine-containing prenatal multiple micronutrient (MMN) supplement in a rural Gambian population at risk of moderate iodine deficiency.  Materials and Methods:  This study uses data and samples collected as a part of the randomized controlled trial Early Nutrition and Immune Development (ENID; ISRCTN49285450) conducted in Keneba, The Gambia. Pregnant women (<20 weeks gestation) were randomized to either a daily supplement of MMNs containing 300 μg of iodine or an iron and folic acid (FeFol) supplement. Randomization was double blinded (participants and investigators). The coprimary outcomes were maternal urinary iodine concentration (UIC) and serum thyroglobulin (Tg), assessed at baseline and at 30 weeks' gestation. Secondary outcomes were maternal serum thyrotropin (TSH), total triiodothyronine (TT3), total thyroxine (TT4) (assessed at baseline and at 30 weeks' gestation), breast milk iodine concentration (BMIC) (assessed at 8, 12, and 24 weeks postpartum), infant serum Tg (assessed at birth [cord], 12, and 24 weeks postpartum), and serum TSH (assessed at birth [cord]). The effect of supplementation was evaluated using mixed effects models.  Results:  A total of 875 pregnant women were enrolled between April 2010 and February 2015. In this secondary analysis, we included women from the MMN ( n  = 219) and FeFol ( n  = 219) arm of the ENID trial. At baseline, median (interquartile range or IQR) maternal UIC and Tg was 51 μg/L (33-82) and 22 μg/L (12-39), respectively, indicating moderate iodine deficiency. Maternal MMN supplement increased maternal UIC ( p  < 0.001), decreased maternal Tg ( p  < 0.001), and cord blood Tg ( p  < 0.001) compared with FeFol. Maternal thyroid function tests (TSH, TT3, TT4, and TT3/TT4 ratio) and BMIC did not differ according to maternal supplement group over the course of the study. Median (IQR) BMIC, maternal UIC, and infant Tg in the MMN group were 51 μg/L (35-72), 39 μg/L (25-64), and 87 μg/L (59-127), respectively, at 12 weeks postpartum, and did not differ between supplement groups.  Conclusions:  Supplementing moderately iodine-deficient women during pregnancy improved maternal iodine status and reduced Tg concentration. However, the effects were not attained postpartum and maternal and infant iodine nutrition remained inadequate during the first six months after birth. Consideration should be given to ensuring adequate maternal status through pregnancy and lactation in populations with moderate deficiency.",2020,"Maternal MMN supplement increased maternal UIC (p<0·001), decreased maternal Tg (p<0·001) and cord blood Tg (p<0.001) compared with FeFol.","['women from the MMN (n=219) and FeFol (n=219) arm of the ENID trial', 'Pregnant women (<20 weeks gestation', '875 pregnant women were enrolled between April 2010 and February 2015', 'rural Gambian population at risk of moderate iodine deficiency', 'pregnant women in iodine deficient populations']","['daily supplement of multiple micronutrients (MMN) containing 300 µg of iodine, or an iron-folic acid (FeFol) supplement', 'iodine-containing prenatal multiple micronutrient', 'iodine containing prenatal multiple micronutrient supplement', 'Iodine supplementation']","['Maternal thyroid function tests (TSH, TT3, TT4, and TT3/TT4 ratio) and BMIC', 'maternal UIC (p<0·001), decreased maternal Tg (p<0·001) and cord blood Tg', 'maternal and infant iodine status and thyroid function', ""maternal urinary iodine concentration (UIC) and serum thyroglobulin (Tg), assessed at baseline and 30 weeks' gestation"", ""maternal serum thyroid stimulating hormone (TSH), total triiodothyronine (TT3), total thyroxine (TT4) (assessed at baseline and 30 weeks' gestation), breast milk iodine concentration (BMIC) (assessed at 8, 12 and 24 weeks postpartum), infant serum Tg (assessed at birth (cord), 12 and 24 weeks postpartum) and serum TSH (assessed at birth (cord"", 'maternal iodine status and reduced Tg concentration']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C0337833', 'cui_str': 'Gambians (ethnic group)'}, {'cui': 'C0242444', 'cui_str': 'Population at Risk'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0342199', 'cui_str': 'Iodine deficiency syndrome (disorder)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0337445', 'cui_str': 'Thyroglobulin measurement (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",875.0,0.156679,"Maternal MMN supplement increased maternal UIC (p<0·001), decreased maternal Tg (p<0·001) and cord blood Tg (p<0.001) compared with FeFol.","[{'ForeName': 'Kamilla G', 'Initials': 'KG', 'LastName': 'Eriksen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': ""Division of Gastroenterology and Nutrition, Children's Research Centre, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hunziker', 'Affiliation': 'Human Nutrition Laboratory, Institute of Food, Nutrition, and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Human Nutrition Laboratory, Institute of Food, Nutrition, and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Moore', 'Affiliation': ""Department of Women and Children's Health, King's College London, London, United Kingdom.""}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0789']
437,32492084,Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial.,"Importance


Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.
Objective


To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.
Design, Setting, and Participants


Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.
Intervention


Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.
Main Outcomes and Measures


Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.
Results


Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.
Conclusion and Relevance


Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.
Trial Registration


Chinese Clinical Trial Registry: ChiCTR2000029757.",2020,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","['patients with COVID-19', 'patients with coronavirus disease 2019 (COVID-19', '60 [58.3%] male), 101 (98.1%) completed the trial', '103 of a planned 200 patients were enrolled', '103 patients who were randomized (median age, 70 years', 'Patients With Severe and Life-threatening COVID-19', '103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation', '7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020']","['Convalescent Plasma Therapy', 'convalescent plasma therapy', 'Intervention\n\n\nConvalescent plasma in addition to standard treatment (n\u2009=\u200952) vs standard treatment alone (control']","['Clinical improvement', 'time to clinical improvement', '28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR', '28-day mortality', 'adverse events', 'efficacy and adverse effects', 'time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale', 'negative conversion rate of viral PCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1299454', 'cui_str': 'Patient discharged alive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",103.0,0.448056,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xunliang', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Respiratory quality control center, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Shangen', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Transfusion, General Hospital of Central Theater Command of PLA, Wuhan, China.'}, {'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Medical Molecular Biology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union, Beijing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Caiying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Cuihua', 'Initials': 'C', 'LastName': 'Tao', 'Affiliation': 'Department of Blood Transfusion, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Wuhan Blood Center, Wuhan, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Xiaoxiong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Man', 'Affiliation': 'Department of Respiratory Medicine, Wuhan Asia General Hospital, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deng', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, and Beijing Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology, University of Miami, Miami, Florida.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}]",JAMA,['10.1001/jama.2020.10044']
438,32150057,Peer support for discharge from inpatient to community mental health services: Study protocol clinical trial (SPIRIT Compliant).,"INTRODUCTION


In the period shortly after discharge from inpatient to community mental health care, people are at increased risk of self-harm, suicide, and readmission to hospital. Discharge interventions including peer support have shown potential, and there is some evidence that community-based peer support reduces readmissions. However, systematic reviews of peer support in mental health services indicate poor trial quality and a lack of reporting of how peer support is distinctive from other mental health support. This study is designed to establish the clinical and cost effectiveness of a peer worker intervention to support discharge from inpatient to community mental health care, and to address issues of trial quality and clarity of reporting of peer support interventions.
METHODS


This protocol describes an individually randomized controlled superiority trial, hypothesizing that people offered a peer worker discharge intervention in addition to usual follow-up care in the community are less likely to be readmitted in the 12 months post discharge than people receiving usual care alone. A total of 590 people will be recruited shortly before discharge from hospital and randomly allocated to care as usual plus the peer worker intervention or care as usual alone. Manualized peer support provided by trained peer workers begins in hospital and continues for 4 months in the community post discharge. Secondary psychosocial outcomes are assessed at 4 months post discharge, and service use and cost outcomes at 12 months post discharge, alongside a mixed methods process evaluation.
DISCUSSION


Clearly specified procedures for sequencing participant allocation and for blinding assessors to allocation, plus full reporting of outcomes, should reduce risk of bias in trial findings and contribute to improved quality in the peer support evidence base. The involvement of members of the study team with direct experience of peer support, mental distress, and using mental health services, in coproducing the intervention and designing the trial, ensures that we theorize and clearly describe the peer worker intervention, and evaluate how peer support is related to any change in outcome. This is an important methodological contribution to the evidence base.
TRIAL REGISTRATION


This study was prospectively registered as ISRCTN 10043328 on November 28, 2016.",2020,"In the period shortly after discharge from inpatient to community mental health care, people are at increased risk of self-harm, suicide, and readmission to hospital.","['November 28, 2016', '590 people will be recruited shortly before discharge from hospital and randomly allocated to']","['care as usual plus the peer worker intervention or care as usual alone', 'peer worker intervention', 'peer worker discharge intervention']","['discharge, and service use and cost outcomes']","[{'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",590.0,0.157639,"In the period shortly after discharge from inpatient to community mental health care, people are at increased risk of self-harm, suicide, and readmission to hospital.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gillard', 'Affiliation': ""Population Health Research Institute, St George's, University of London, Cranmer Terrace, London.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton & Sussex Medical School, University of Brighton, Brighton.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Sarah Louise', 'Initials': 'SL', 'LastName': 'Gibson', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Goldsmith', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""Health Services & Population Research Department, King's College London, London.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lucock', 'Affiliation': 'School of Human & Health Sciences, University of Huddersfield, Huddersfield.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Marks', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Rosaleen', 'Initials': 'R', 'LastName': 'Morshead', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Pragmatic Clinical Trials Unit.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary, University of London, London.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Repper', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Rinaldi', 'Affiliation': ""South West London & St George's Mental Health NHS Trust.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': ""Health Services & Population Research Department, King's College London, London.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': ""Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""Population Health Research Institute, St George's, University of London.""}]",Medicine,['10.1097/MD.0000000000019192']
439,32175901,Cemented versus uncemented hemiarthroplasty for displaced femoral neck fractures: A randomized controlled trial with two years follow-up.,"OBJECTIVE


The aim of this prospective randomized trial was to compare cemented (CHA) and uncemented bipolar hemiarthroplasty (UCH) in patients with femoral neck fractures (FNF).
METHODS


The study included 158 patients aged ≥76 years who underwent bipolar HA for displaced FNF. Patients were randomized in two groups: the cemented group (CHA, n=79) was treated with cement and the uncemented group (UCH, n=79) without cement. The groups were compared for operating time, blood loss and peroperative morbidity and mortality rates.
RESULTS


Both the CHA and the UCH group did not differ significantly in terms of age (86±5 vs. 84±4 years), sex (58.3% male vs. 60.7% female), and comorbidities (p=0.49). The CHA group had a significantly longer operating time (p=0.038) and a greater intraoperative blood loss (p=0.024). In the CHA group there were 8 (10.1%) events of intraoperative drop in the oxygen saturation (SaO2), whereas no such events were noted in the UCH group (p=0.009). Despite no significant difference between these two groups, we found that the CHA group was associated with a higher early postoperative mortality (8.8% in the CHA group versus 3.8% in the UCH group, p=0.009). Intraoperative fracture occurred in two patients (2.5%) of the UCH group. Over a 2-year follow-up period there were no significant differences between the groups regarding the rate of dislocation (p=0.56) or rate of postoperative periprosthetic fracture (p=0.56). There was a trend towards a better postoperative functional recovery at 6 week for the CHA group (77.1±13.1 versus 71.3±16.3), although the mean Harris Hip Score (HHS) at the end of 2 years was comparable (p=0.55).
CONCLUSION


Both CHA and UCH are acceptable methods for treating displaced femoral neck fractures. However, based on our results perioperative cardiovascular disturbances are less frequent and resulting in a potential lower early mortality with UCH. Therefore, UCH is particularly appropriate for elderly patients with pre-existing cardiovascular comorbidities.
LEVEL OF EVIDENCE


Level II, Randomized Controlled Trial.",2020,The CHA group had a significantly longer operating time (p=0.038) and a greater intraoperative blood loss (p=0.024).,"['elderly patients with pre-existing cardiovascular comorbidities', '158 patients aged ≥76 years who underwent bipolar HA for displaced FNF', 'displaced femoral neck fractures', 'patients with femoral neck fractures (FNF']","['cemented (CHA) and uncemented bipolar hemiarthroplasty (UCH', 'Cemented versus uncemented hemiarthroplasty', 'cemented group (CHA, n=79) was treated with cement and the uncemented group (UCH, n=79) without cement', 'CHA', 'CHA and UCH', 'UCH']","['early postoperative mortality', 'postoperative functional recovery', 'operating time, blood loss and peroperative morbidity and mortality rates', 'oxygen saturation (SaO2', 'mean Harris Hip Score (HHS', 'rate of dislocation (p=0.56) or rate of postoperative periprosthetic fracture', 'longer operating time', 'intraoperative blood loss', 'Intraoperative fracture']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C2609162', 'cui_str': 'Periprosthetic Fractures'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0436007', 'cui_str': 'Intraoperative fracture (disorder)'}]",158.0,0.0601205,The CHA group had a significantly longer operating time (p=0.038) and a greater intraoperative blood loss (p=0.024).,"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Movrin', 'Affiliation': 'Department of Traumatology, University Medical Centre Maribor, Maribor, Slovenia.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.01.432']
440,32193622,"A Double-Blind, Randomized Controlled Trial of Pre-incision Wound Infiltration Using Diclofenac Versus Bupivacaine for Post-operative Pain Relief in Open Thyroid and Parathyroid Surgery.","BACKGROUND


Pre-incision wound infiltration using NSAID is an alternative method to manage post-operative pain in surgery. It is postulated that NSAID delivered peripherally exerts efficient analgesic and anti-inflammatory effect with minimal systemic complication. This study explored the efficacy of using diclofenac for wound infiltration in open thyroidectomy and parathyroidectomy as compared to conventional agent, bupivacaine.
METHODOLOGY


The study was designed as a double-blind, randomized controlled trial involving 94 patients who underwent open thyroidectomy or parathyroidectomy in Hospital Pulau Pinang, Malaysia, from November 2015 to November 2016. The study compared the efficacy of pre-incision wound infiltration of diclofenac (n = 47) versus bupivacaine (n = 47) in post-operative pain relief. Wound infiltration is given prior to skin incision. Mean pain score at designated time interval within the 24-h post-operative period, time to first analgesia, total analgesic usage and total analgesic cost were assessed.
RESULTS


Ninety-four patients were recruited with no dropouts. Mean age was 49.3 (SD = 14.2) with majority being female (74.5%). Ethnic distribution recorded 42.6% Chinese, 38.3% Malay, followed by 19.1% Indian. Mean duration of surgery was 123.8 min (SD = 56.5), and mean length of hospital stay was 4.7 days (SD = 1.8). The characteristics of patient in both groups were generally comparable except that there were more cases of total thyroidectomy in the diclofenac group (n = 31) as compared to the bupivacaine group (n = 16). Mean pain score peaked at immediate post-operative period (post-operative 0.5 h) with a score of 3.5 out of 10 and the level decreased steadily over the next 20 h starting from 4 h post-operatively. Pre-incision wound infiltration using diclofenac had better pain control as compared to bupivacaine at all time interval assessed. In the resting state, the mean post-operative pain score difference was statistically significant at 2 h [2.1 (SD = 1.5) vs. 2.8 (SD = 1.8), p = 0.04]. During neck movement, the dynamic pain score difference was statistically significant at post-operative 1 h [2.7 (SD = 1.9) vs. 3.7 (SD = 2.1), p = 0.02]; 2 h [2.7 (SD = 1.6) vs. 3.7 (SD = 2.0), p = 0.01]; 4 h [2.2 (SD = 1.5) vs. 2.9 (SD = 1.7), p = 0.04], 6 h [1.9 (SD = 1.4) vs. 2.5 (SD = 1.6), p = 0.04] and 12 h [1.5 (SD = 1.5) vs. 2.2 (SD = 1.4), p = 0.03]. Mean dose of tramadol used as rescue analgesia in 24 h duration was lower in the diclofenac group as compared to bupivacaine group [13.8 mg (SD = 24.9) vs. 36.2 mg (SD = 45.1), p = 0.01]. The total cost of analgesia used was significantly cheaper in diclofenac group as compared to bupivacaine group [RM 3.47 (SD = 1.51) vs. RM 13.43 (SD = 1.68), p < 0.01] or [USD 0.83 (SD = 0.36) vs. USD 3.21 (SD = 0.40), p < 0.01].
CONCLUSION


Pre-incision wound infiltration using diclofenac provides better post-operative pain relief compared to bupivacaine for patient who had underwent open thyroidectomy or parathyroidectomy. Diclofenac is cheap and easily available in the limited resource setting. This approach offers a superior alternative for post-operative pain relief as compared to bupivacaine.",2020,"CONCLUSION


Pre-incision wound infiltration using diclofenac provides better post-operative pain relief compared to bupivacaine for patient who had underwent open thyroidectomy or parathyroidectomy.","['patient who had underwent open thyroidectomy or parathyroidectomy', 'Open Thyroid and Parathyroid Surgery', 'Ninety-four patients were recruited with no dropouts', 'in Hospital Pulau Pinang, Malaysia, from November 2015 to November 2016', 'Mean age was 49.3 (SD\u2009=\u200914.2) with majority being female (74.5', '94 patients who underwent']","['Diclofenac', 'tramadol', 'bupivacaine', 'Diclofenac Versus Bupivacaine', 'diclofenac', 'open thyroidectomy or parathyroidectomy']","['Mean pain score', 'mean post-operative pain score difference', 'pain control', 'Mean duration of surgery', 'total thyroidectomy', 'mean length of hospital stay', 'dynamic pain score difference', 'time to first analgesia, total analgesic usage and total analgesic cost', 'total cost of analgesia', 'rescue analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",94.0,0.125844,"CONCLUSION


Pre-incision wound infiltration using diclofenac provides better post-operative pain relief compared to bupivacaine for patient who had underwent open thyroidectomy or parathyroidectomy.","[{'ForeName': 'Jing Wen', 'Initials': 'JW', 'LastName': 'Loh', 'Affiliation': 'Department of Surgery, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nur Aishah', 'Initials': 'NA', 'LastName': 'Taib', 'Affiliation': 'Department of Surgery, University of Malaya, Kuala Lumpur, Malaysia. nuraish@gmail.com.'}, {'ForeName': 'Yew Teik', 'Initials': 'YT', 'LastName': 'Cheong', 'Affiliation': 'Department of Surgery, Hospital Penang, Penang, Malaysia.'}, {'ForeName': 'Tin Su', 'Initials': 'TS', 'LastName': 'Tin', 'Affiliation': 'Department of Social and Preventive Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.'}]",World journal of surgery,['10.1007/s00268-020-05458-6']
441,32189116,"Correction to: Surgeon-delivered laparoscopic transversus abdominis plane blocks are non-inferior to anesthesia-delivered ultrasound-guided transversus abdominis plane blocks: a blinded, randomized non-inferiority trial.",The following text should have been included in the Acknowledgments.,2020,The following text should have been included in the Acknowledgments.,[],"['Surgeon-delivered laparoscopic transversus abdominis plane blocks', 'anesthesia-delivered ultrasound-guided transversus abdominis plane blocks']",[],[],"[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]",[],,0.253585,The following text should have been included in the Acknowledgments.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Curran', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Vitaliy Y', 'Initials': 'VY', 'LastName': 'Poylin', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cataldo', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA. Tcatald1@bidmc.harvard.edu.'}]",Surgical endoscopy,['10.1007/s00464-020-07505-8']
442,32189108,'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab.,"BACKGROUND


The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension.
METHODS


Attainment of 'minimal symptom expression' was evaluated using patient-reported outcome measures of gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15)] at the completion of REGAIN and during the open-label extension. 'Minimal symptom expression' was defined as MG-ADL total score of 0-1 or MG-QOL15 total score of 0-3.
RESULTS


At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069]. During the open-label extension, the proportion of patients in the placebo/eculizumab group who achieved 'minimal symptom expression' increased after initiating eculizumab treatment and was sustained through 130 weeks of open-label eculizumab (MG-ADL: 1.7 to 27.8%; MG-QOL15: 1.7 to 19.4%). At extension study week 130, similar proportions of patients in the eculizumab/eculizumab and placebo/eculizumab groups achieved 'minimal symptom expression' (MG-ADL: 22.9% and 27.8%, respectively, p = 0.7861; MG-QOL15: 14.3% and 19.4%, respectively, p = 0.7531). The long-term tolerability of eculizumab was consistent with previous reports.
CONCLUSIONS


Patients with AChR+ refractory gMG who receive eculizumab can achieve sustained 'minimal symptom expression' based on patient-reported outcomes. 'Minimal symptom expression' may be a useful tool in measuring therapy effectiveness in gMG.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01997229, NCT02301624.",2020,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","['patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with', 'Patients with AChR+ refractory gMG']","['placebo/eculizumab', 'acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG', 'placebo', 'eculizumab/eculizumab and placebo/eculizumab', 'placebo [MG-ADL', 'open-label eculizumab (MG-ADL', 'eculizumab']","['minimal symptom expression', 'Minimal symptom expression', 'gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0765796', 'cui_str': 'GMG'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0905574,"At REGAIN week 26, more eculizumab-treated patients achieved 'minimal symptom expression' versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069].","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Department of Neurology, Copenhagen Neuromuscular Center, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark. john.vissing@regionh.dk.'}, {'ForeName': 'Saiju', 'Initials': 'S', 'LastName': 'Jacob', 'Affiliation': 'Queen Elizabeth Neuroscience Centre and Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.'}, {'ForeName': 'Kenji P', 'Initials': 'KP', 'LastName': 'Fujita', 'Affiliation': 'Alnylam Pharmaceuticals, 675 West Kendall Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': ""O'Brien"", 'Affiliation': 'Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA, 02210, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'Department of Neurology, University of North Carolina, 170 Manning Drive, Chapel Hill, NC, 27599-7025, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09770-y']
443,32186161,Effects of Huangban Bianxing One decoction combined with ranibizumab on treating exudative age-related macular degeneration.,"OBJECTIVE


To evaluate the clinical efficacy and safety of Chinese medicine formula Huangban Bianxing One decoction (HBOD) combined with ranibizumab for treating exudative age-related macular degeneration (AMD) patients.
METHODS


Totally 75 cases with exudative AMD (75 eyes) were enrolled in this study and randomly divided into two groups to receive either HBOD with ranibizumab or only ranibizumab. Early treatment diabetic retinopathy study (ETDRS) letters for the best corrected visual acuity, center macular thickness (CMT), height of the lesion, fundus hemorrhage area, fundus fluorescein leakage area as the main outcomes and safety indexes were estimated and compared before and after treatment for 3 or 6 months.
RESULTS


Comparing with the before treatment, ETDRS letter scores of both groups after treatment at month 3 obtained a greater improvement (P < 0.05), but the significant improvement only existed in the HBOD+ranibizumab group at month 6 (P < 0.01), and better than the ranibizumab group (P < 0.05). At month 3, the CMT and lesion height of both groups were significantly lower than those before treatment (P < 0.01 or P < 0.05) and the HBOD + ranibizumab group had a similar result at month 6 (P < 0.01). The hemorrhage area and fluorescein leakage area of the HBOD+ranibizumab group were also significantly reduced and also smaller than those of the ranibizumab group at month 6 (P < 0.01 or P < 0.05). During treatment, no significant adverse events relating to HBOD or ranibizumab treatment were elucidated.
CONCLUSION


HBOD combined with ranibizumab can improve visual acuity and reduce hemorrhage and fluorescein leakage of patients with exudative AMD. These results also indicated that HBOD may function as an effective and safe adjuvant drug for exudative AMD.",2019,"At month 3, the CMT and lesion height of both groups were significantly lower than those before treatment (P < 0.01 or P < 0.05) and the HBOD + ranibizumab group had a similar result at month 6 (P < 0.01).","['treating exudative age-related macular degeneration', 'patients with exudative AMD', 'exudative age-related macular degeneration (AMD) patients', 'Totally 75 cases with exudative AMD (75 eyes']","['HBOD with ranibizumab or only ranibizumab', 'HBOD + ranibizumab', 'Chinese medicine formula Huangban Bianxing One decoction (HBOD) combined with ranibizumab', 'ranibizumab', 'Huangban Bianxing One decoction combined with ranibizumab']","['hemorrhage area and fluorescein leakage area', 'CMT and lesion height', 'visual acuity and reduce hemorrhage and fluorescein leakage', 'corrected visual acuity, center macular thickness (CMT), height of the lesion, fundus hemorrhage area, fundus fluorescein leakage area', 'ETDRS letter scores']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311438', 'cui_str': 'Exudative (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",75.0,0.0232739,"At month 3, the CMT and lesion height of both groups were significantly lower than those before treatment (P < 0.01 or P < 0.05) and the HBOD + ranibizumab group had a similar result at month 6 (P < 0.01).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Deng', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
444,32186216,The effect of dopamine on the comprehension of spectrally-shifted noise-vocoded speech: a pilot study.,"Objectives:  Cochlear implantation has proven beneficial in restoring hearing. However, success is variable, and there is a need for a simple post-implantation therapy that could significantly increase implantation success. Dopamine has a general role in learning and in assigning value to environmental stimuli. We tested the effect of dopamine in the comprehension of spectrally-shifted noise-vocoded (SSNV) speech, which simulates, in hearing individuals, the signal delivered by a cochlear implant (CI). Design and study sample:  Thirty-five participants (age = 38.0 ± 10.1 SD) recruited from the general population were divided into three groups. We tested SSNV speech comprehension in two experimental sessions. In one session, a metabolic precursor of dopamine (L-DOPA) was administered to participants in two of the groups; a placebo was administered in the other session. Results:  A single dose of L-DOPA interacted with training to improve perception of SSNV speech, but did not significantly accelerate learning. Conclusions:  These findings are a first step in exploring the use of dopamine to enhance speech understanding in CI patients. Replications of these results using SSNV in individuals with normal hearing, and also in CI users, are needed to determine whether these effects can translate into benefits in everyday language comprehension.",2020,"A single dose of L-DOPA interacted with training to improve perception of SSNV speech, but did not significantly accelerate learning.","['study sample:  Thirty-five participants (age = 38.0\u2009±\u200910.1 SD) recruited from the general population', 'CI patients', 'individuals with normal hearing, and also in CI users']","['Dopamine', 'Cochlear implantation', 'L-DOPA', 'placebo', 'dopamine']","['implantation success', 'perception of SSNV speech']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0302559', 'cui_str': 'Cochlear Prosthesis Implantation'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",35.0,0.0270881,"A single dose of L-DOPA interacted with training to improve perception of SSNV speech, but did not significantly accelerate learning.","[{'ForeName': 'Velia', 'Initials': 'V', 'LastName': 'Cardin', 'Affiliation': 'Deafness, Cognition and Language Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Speech, Hearing and Phonetics Sciences, UCL, London, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Konieczny', 'Affiliation': 'Deafness, Cognition and Language Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Coulson', 'Affiliation': 'Deafness, Cognition and Language Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lametti', 'Affiliation': 'Department of Psychology, Acadia University, Wolfville, Nova Scotia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': ""Neuroscience Research Centre, Institute of Molecular and Clinical Sciences, St George's University of London, London, United Kingdom.""}, {'ForeName': 'Bencie', 'Initials': 'B', 'LastName': 'Woll', 'Affiliation': 'Deafness, Cognition and Language Research Centre, University College London, London, United Kingdom.'}]",International journal of audiology,['10.1080/14992027.2020.1734675']
445,32039811,"Brief, Web-Based Interventions to Motivate Smokers With Schizophrenia: Randomized Trial.","BACKGROUND


In-person motivational interventions increase engagement with evidence-based cessation treatments among smokers with schizophrenia, but access to such interventions can be limited because of workforce shortages and competing demands in mental health clinics. The use of digital technology to deliver interventions can increase access, but cognitive impairments in schizophrenia may impede the use of standard digital interventions. We developed an interactive, multimedia, digital motivational decision support system for smokers with schizophrenia (Let's Talk About Smoking). We also digitalized a standard educational pamphlet from the National Cancer Institute (NCI Education). Both were tailored to reduce cognitive load during use.
OBJECTIVE


We conducted a randomized trial of Let's Talk About Smoking versus NCI Education to test whether the interactive motivational intervention was more effective and more appealing than the static educational intervention for increasing use of smoking cessation treatment, quit attempts, and abstinence among smokers with schizophrenia, accounting for the level of cognitive functioning.
METHODS


Adult smokers with schizophrenia (n=162) were enrolled in the study from 2014 to 2015, randomly assigned to intervention condition, and assessed in person at 3- and 6-month follow-ups. Interventions were delivered on a laptop computer in a single session. All participants had access to standard, community-delivered cessation treatments during follow-up. Multivariate models were used to evaluate outcomes.
RESULTS


Treatment initiation outcomes were not different between intervention conditions (27/84 [32%] for Let's Talk About Smoking vs 36/78 [46%] for NCI Education; odds ratio [OR] 0.71 [95% CI 0.37-1.33]); 38.9% (63/162) of participants initiated treatment. Older age (OR 1.03 [95% CI 1.00-1.07]; P=.05), higher education (OR 1.21 [95% CI 1.04-1.41]; P=.03), and fewer positive symptoms (OR 0.87 [95% CI 0.80-0.96]; P=.01) predicted cessation treatment initiation, whereas level of cognition did not. The mean satisfaction and usability index score was higher for Let's Talk About Smoking versus NCI Education (8.9 [SD 1.3] vs 8.3 [SD 2.1]; t 120.7 =2.0; P=.045). Quit attempts (25/84, 30% vs 36/78, 46%; estimate [Est]=-0.093, SE 0.48; P=.85) and abstinence (1/84, 1% vs 6/78, 7%; χ21=3.4; P=.07) were not significantly different between intervention conditions. Cognitive functioning at baseline (Est=1.47, SE 0.47; P=.002) and use of any behavioral or medication cessation treatment (Est=1.43, SE 0.47; P=.003) predicted quit attempts with self-reported abstinence over the 6-month follow-up.
CONCLUSIONS


The interactive, multimedia intervention was not more effective than the static, text-based intervention among smokers with schizophrenia. Both tailored digital interventions resulted in levels of treatment engagement and quit attempts that were similar to findings from previous studies of in-person interventions, confirming the potential role of digital interventions to educate and motivate smokers with schizophrenia to use cessation treatment and to quit smoking. These findings indicate that additional cessation treatment is needed after brief education or motivational interventions, and that cessation treatment should be adjusted for people with cognitive impairment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02086162; https://clinicaltrials.gov/show/NCT02086162.",2020,"RESULTS


Treatment initiation outcomes were not different between intervention conditions (27/84 [32%] for Let's Talk About Smoking vs 36/78 [46%] for NCI Education; odds ratio [OR] 0.71","['smokers with schizophrenia, accounting for the level of cognitive functioning', 'Adult smokers with schizophrenia (n=162) were enrolled in the study from 2014 to 2015, randomly assigned to intervention condition, and assessed in person at 3- and 6-month follow-ups', 'smokers with schizophrenia ', 'people with cognitive impairment', 'smokers with schizophrenia', 'Motivate Smokers With Schizophrenia']","['static educational intervention', 'interactive motivational intervention']","['mean satisfaction and usability index score', 'positive symptoms', 'Cognitive functioning', 'quit attempts with self-reported abstinence', 'Quit attempts', 'abstinence']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",162.0,0.0848978,"RESULTS


Treatment initiation outcomes were not different between intervention conditions (27/84 [32%] for Let's Talk About Smoking vs 36/78 [46%] for NCI Education; odds ratio [OR] 0.71","[{'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Brunette', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock, Concord, NH, United States.'}, {'ForeName': 'Joelle C', 'Initials': 'JC', 'LastName': 'Ferron', 'Affiliation': 'Dartmouth-Hitchcock, Concord, NH, United States.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'McGurk', 'Affiliation': 'Boston University, Boston, MA, United States.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Rutgers, New Brunswick, NJ, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harrington', 'Affiliation': 'University of Massachusetts, Worcester, MA, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Devitt', 'Affiliation': 'Thresholds, Inc, Chicago, IL, United States.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock, Concord, NH, United States.'}]",JMIR mental health,['10.2196/16524']
446,31732098,Efficacy of Nivolumab plus Ipilimumab According to Number of IMDC Risk Factors in CheckMate 214.,"In the randomized, open-label, phase 3 CheckMate 214 trial, nivolumab plus ipilimumab (nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 wk for four doses, then nivolumab 3 mg/kg every 2 wk) had superior efficacy over sunitinib (50 mg once daily, 4 wk on, 2 wk off) in patients with untreated International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk advanced renal cell carcinoma; the benefits were sustained through extended follow-up. To better characterize the association between outcomes and IMDC risk in CheckMate 214, we completed a post hoc analysis (n = 1051) of efficacy by the number of IMDC risk factors. The investigator-assessed objective response rate (ORR), overall survival (OS), and investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors v1.1 were evaluated. ORR with nivolumab plus ipilimumab was consistent across zero to six IMDC risk factors, whereas with sunitinib it decreased with increasing number of risk factors. Benefits of nivolumab plus ipilimumab over sunitinib in terms of ORR (40-44% vs 16-38%), OS (hazard ratio [HR] 0.50-0.72), and PFS (HR 0.44-0.86) were consistently observed in subgroups with one, two, three, or four to six IMDC risk factors (p < 0.05 for treatment × no. of risk factors interaction). These results demonstrate the benefit of first-line nivolumab plus ipilimumab over sunitinib across all intermediate-risk and poor-risk groups, regardless of the number of IMDC risk factors. PATIENT SUMMARY: This report from the CheckMate 214 study describes a consistent efficacy benefit with first-line nivolumab plus ipilimumab over first-line sunitinib in all groups of patients with intermediate-risk or poor-risk advanced renal cell carcinoma, regardless of the number of risk factors they had before starting treatment. We conclude that there is a benefit of first-line treatment with nivolumab plus ipilimumab for all intermediate-risk patients, including those with one or two risk factors, and for all poor-risk patients, independent of the number of risk factors.",2020,"ORR with nivolumab plus ipilimumab was consistent across zero to six IMDC risk factors, whereas with sunitinib it decreased with increasing number of risk factors.","['patients with untreated International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk advanced renal cell carcinoma', 'patients with intermediate-risk or poor-risk advanced renal cell carcinoma, regardless of the number of risk factors they had before starting treatment']","['nivolumab plus ipilimumab (nivolumab 3\u2009mg/kg plus ipilimumab', 'first-line nivolumab plus ipilimumab', 'nivolumab plus ipilimumab', 'sunitinib', 'Nivolumab plus Ipilimumab']","['objective response rate (ORR), overall survival (OS), and investigator-assessed progression-free survival (PFS', 'ORR', 'number of risk factors', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",214.0,0.038159,"ORR with nivolumab plus ipilimumab was consistent across zero to six IMDC risk factors, whereas with sunitinib it decreased with increasing number of risk factors.","[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France. Electronic address: escudier@gustaveroussy.fr.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia, Pavia, Italy; Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Niigata University, Niigata, Japan.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Maurer', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}]",European urology,['10.1016/j.eururo.2019.10.025']
447,30139562,Behavior Modification of Diet and Parent Feeding Practices in a Community- Vs Primary Care-Centered Intervention for Childhood Obesity.,"OBJECTIVE


To evaluate behavior modification of diet and parent feeding practices in childhood obesity interventions.
DESIGN


Secondary analysis of randomized, controlled trial comparing Mind, Exercise, Nutrition … Do It! (MEND2-5 and MEND/Coordinated Approach to Child Health [CATCH6-12]) vs Next Steps at baseline and 3 and 12 months.
SETTING


Austin and Houston, TX.
PARTICIPANTS


A total of 549 Hispanic and black children randomized to programs by age groups (2-5, 6-8, and 9-12 years) INTERVENTIONS: Twelve-month MEND2-5 and MEND/CATCH6-12 vs Next Steps.
MAIN OUTCOME MEASURE(S)


Diet (MEND-friendly/unfriendly food groups and Healthy Eating Index-2010) and parent feeding practices (parental overt control, discipline, limit setting, monitoring, reinforcement, modeling, and covert control; and food neophobia).
ANALYSIS


Mixed-effects linear regression.
RESULTS


Changes in diet quality, consumption of MEND-unfriendly foods, and parent feeding practices did not differ between programs. In both interventions, MEND-unfriendly vegetables, grains, dairy and protein, added fat and desserts/sugar-sweetened beverages declined in 2-5- and 6-8-year-olds (P < .001). Healthy Eating Index-2010 improved in 2-5- (treatment; P = .002) and 6-8-year-olds (P = .001). Parental overt control decreased and limit setting, discipline, monitoring, reinforcement, and covert control increased with both interventions in 2-5- and 6-8-year-olds (P < 0.01-0.001).
CONCLUSIONS


Diet quality, consumption of MEND-unfriendly foods, and parent feeding practices were altered constructively in 2 pediatric obesity interventions, especially in 2-5- and 6-8-year-olds.",2019,"Parental overt control decreased and limit setting, discipline, monitoring, reinforcement, and covert control increased with both interventions in 2-5- and 6-8-year-olds (P < 0.01-0.001).
","['Childhood Obesity', 'Austin and Houston, TX', 'A total of 549 Hispanic and black children randomized to programs by age groups (2-5, 6-8, and 9-12 years']","['Diet and Parent Feeding Practices', 'Mind, Exercise, Nutrition', 'Diet (MEND-friendly/unfriendly food groups and Healthy Eating Index-2010) and parent feeding practices (parental overt control, discipline, limit setting, monitoring, reinforcement, modeling, and covert control; and food neophobia', 'diet and parent feeding practices']","['Parental overt control decreased and limit setting, discipline, monitoring, reinforcement, and covert control', 'Healthy Eating Index-2010', 'diet quality, consumption of MEND-unfriendly foods, and parent feeding practices']","[{'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0605411', 'cui_str': 'austin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0671679', 'cui_str': 'MEND'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0150269', 'cui_str': 'Limit setting (procedure)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0671679', 'cui_str': 'MEND'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",549.0,0.0329885,"Parental overt control decreased and limit setting, discipline, monitoring, reinforcement, and covert control increased with both interventions in 2-5- and 6-8-year-olds (P < 0.01-0.001).
","[{'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Wilson', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Adolph', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sacher', 'Affiliation': 'Childhood Nutrition Research Centre, University College London, London, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Barlow', 'Affiliation': ""Children's Health, GI Practice, University of Texas Southwestern Medical Center, Dallas, TX.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pont', 'Affiliation': ""Texas Center for the Prevention and Treatment of Childhood Obesity, Dell Children's Medical Center University of Texas at Austin Dell Medical School, Austin, TX.""}, {'ForeName': 'Shreela', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, Houston, TX.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Byrd-Williams', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health in Austin, Austin, TX.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health in Austin, Austin, TX. Electronic address: Melissa.A.Camposhernandez@uth.tmc.edu.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Butte', 'Affiliation': ""US Department of Agriculture, Agricultural Research Service Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX.""}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.05.010']
448,30871936,Pilot study on functional performance and acceptability of two new synthetic adhesive male condoms (Wondaleaf): a randomized cross-over trial.,"OBJECTIVES


This study compared the condom failure rate, safety and acceptability of two new synthetic adhesive male condoms, Wondaleaf-Cap® (WLC) and Wondaleaf-On-Man® (WLM), with a marketed latex external condom Durex®-Together (DT).
STUDY DESIGN


We enrolled healthy married, monogamous, heterosexual condom users in a randomized controlled, cross-over, pilot trial in Malaysia. We randomized participants to six groups with different condom use-orders of the experimental WLC and WLM and control latex condom for four episodes for vaginal sex over 1 month for each condom type. We summarized the clinical and non-clinical failure rate, safety and acceptability of each condom type using descriptive statistics. We tested differences in condom failure and acceptability using generalized estimating equations and repeated measure ANOVA respectively.
RESULTS


We screened 75 couples and randomized 50 eligible couples. Two couples withdrew before receiving any condom. The remaining used 576 condoms with 192 uses for each condom variant. Clinical failure rates of WLC, WLM and DT were 1.04%, 0% and 0.52%, respectively. Non-clinical failure rates of WLC, WLM and DT were 2.08%, 3.12% and 1.04%, respectively. Removal was found more painful with Wondaleaf products than the DT. Preferences of participants for WLC, WLM and DT were 33.3%, 29.2% and 25%, respectively. Overall, WLC and DT had greater acceptances among male participants than WLM.
CONCLUSION


Results of this pilot study support that use of synthetic adhesive male condoms is associated with failure rates similar to those seen with existing latex, and with greater acceptability. A larger study to ascertain non-inferiority is underway.
IMPLICATIONS


The availability of synthetic adhesive male condoms may increase the acceptability of condom use. However, removal pain and clinical performance requires further study.",2019,"Clinical failure rates of WLC, WLM and DT were 1.04%, 0% and 0.52%, respectively.","['enrolled healthy married, monogamous, heterosexual condom users in a randomized controlled, cross-over, pilot trial in Malaysia', '75 couples and randomized 50 eligible couples']","['WLC and WLM and control latex condom', 'synthetic adhesive male condoms (Wondaleaf', 'synthetic adhesive male condoms, Wondaleaf-Cap® (WLC) and Wondaleaf-On-Man® (WLM']","['failure rates', 'functional performance and acceptability', 'condom failure rate, safety and acceptability', 'Clinical failure rates of WLC, WLM and DT']","[{'cui': 'C0558125', 'cui_str': 'Monogamous (finding)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3873750', 'cui_str': 'Latex condom'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3853978'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",50.0,0.218345,"Clinical failure rates of WLC, WLM and DT were 1.04%, 0% and 0.52%, respectively.","[{'ForeName': 'Chuo Yew', 'Initials': 'CY', 'LastName': 'Ting', 'Affiliation': 'Sarawak Research Society, Lot 56, Phase 5, Lorong Greenwood 21, Greenwood Park Batu 9 ½ Jalan Kuching-Serian, 94200 Kuching, Sarawak, Malaysia; Institute of Borneo Studies, Universiti Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia. Electronic address: tingchuoyew@gmail.com.'}, {'ForeName': 'Rachel Sing-Kiat', 'Initials': 'RS', 'LastName': 'Ting', 'Affiliation': 'Monash University Malaysia, Jeffrey Cheah School of Medicine and Health Sciences, Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia. Electronic address: ting.singkiat@monash.edu.'}, {'ForeName': 'Chien Joo', 'Initials': 'CJ', 'LastName': 'Lim', 'Affiliation': 'Clinical Research Center, Sarawak General Hospital, Jalan Hospital, 93586, Kuching, Sarawak, Malaysia. Electronic address: limchienjoo90@gmail.com.'}, {'ForeName': 'Teck Long', 'Initials': 'TL', 'LastName': 'King', 'Affiliation': 'Clinical Research Center, Sarawak General Hospital, Jalan Hospital, 93586, Kuching, Sarawak, Malaysia; Pharmacy Department, Sarawak General Hospital, Jalan Hospital, 93586, Kuching, Sarawak, Malaysia. Electronic address: kingtl.crc@gmail.com.'}, {'ForeName': 'Hiram', 'Initials': 'H', 'LastName': 'Ting', 'Affiliation': 'Sarawak Research Society, Lot 56, Phase 5, Lorong Greenwood 21, Greenwood Park Batu 9 ½ Jalan Kuching-Serian, 94200 Kuching, Sarawak, Malaysia; Faculty of Hospitality and Tourism Management, UCSI University, Muara Tebas Land District, Sejingkat, 93450 Kuching, Sarawak, Malaysia. Electronic address: hiramparousia@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gerofi', 'Affiliation': 'Enersol Pty Ltd, 235 Nelson St, Annandale, NSW, 2038, Australia. Electronic address: jgerofi@enersol.com.au.'}]",Contraception,['10.1016/j.contraception.2019.02.013']
449,31622159,Potato ingestion is as effective as carbohydrate gels to support prolonged cycling performance.,"Carbohydrate (CHO) ingestion is an established strategy to improve endurance performance. Race fuels should not only sustain performance but also be readily digested and absorbed. Potatoes are a whole-food-based option that fulfills these criteria, yet their impact on performance remains unexamined. We investigated the effects of potato purée ingestion during prolonged cycling on subsequent performance vs. commercial CHO gel or a water-only condition. Twelve cyclists (70.7 ± 7.7 kg, 173 ± 8 cm, 31 ± 9 yr, 22 ± 5.1% body fat; means ± SD) with average peak oxygen consumption (V̇o 2peak ) of 60.7 ± 9.0 mL·kg -1 ·min -1  performed a 2-h cycling challenge (60-85% V̇o 2peak ) followed by a time trial (TT; 6 kJ/kg body mass) while consuming potato, gel, or water in a randomized-crossover design. The race fuels were administered with [U- 13 C 6 ]glucose for an indirect estimate of gastric emptying rate. Blood samples were collected throughout the trials. Blood glucose concentrations were higher ( P  < 0.001) in potato and gel conditions compared with water condition. Blood lactate concentrations were higher ( P  = 0.001) after the TT completion in both CHO conditions compared with water condition. TT performance was improved ( P  = 0.032) in both potato (33.0 ± 4.5 min) and gel (33.0 ± 4.2 min) conditions compared with water condition (39.5 ± 7.9 min). Moreover, no difference was observed in TT performance between CHO conditions ( P  = 1.00). In conclusion, potato and gel ingestion equally sustained blood glucose concentrations and TT performance. Our results support the effective use of potatoes to support race performance for trained cyclists. NEW & NOTEWORTHY  The ingestion of concentrated carbohydrate gels during prolonged exercise has been shown to promote carbohydrate availability and improve exercise performance. Our study aim was to expand and diversify race fueling menus for athletes by providing an evidence-based whole-food alternative to the routine ingestion of gels during training and competition. Our work shows that russet potato ingestion during prolonged cycling is as effective as carbohydrate gels to support exercise performance in trained athletes.",2019,Blood glucose concentrations were higher ( P< 0.001) in potato and gel conditions when compared to water condition.,"['Twelve cyclists (70.7 ± 7.7 kg, 173 ± 8 cm, 31± 9 years, 22 ± 5.1 % body fat; mean ± SD) with average peak oxygen consumption (VO 2PEAK )of 60.7 ± 9.0 mL/kg/min performed a 2 h cycling challenge (60-85%VO 2PEAK ']","['Carbohydrate (CHO) ingestion', 'U', 'commercial CHO gel', 'potato purée ingestion']","['blood glucose concentrations and TT performance', 'TT performance', 'Blood lactate concentrations', 'gastric emptying rate', 'Blood glucose concentrations', 'endurance performance']","[{'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0032846', 'cui_str': 'Potato'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",,0.0787638,Blood glucose concentrations were higher ( P< 0.001) in potato and gel conditions when compared to water condition.,"[{'ForeName': 'Amadeo F', 'Initials': 'AF', 'LastName': 'Salvador', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'McKenna', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Alamilla', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Ryan M T', 'Initials': 'RMT', 'LastName': 'Cloud', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Keeble', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Miltko', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Scaroni', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Beals', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Ulanov', 'Affiliation': 'Roy J. Carver Biotechnology Center, Urbana, Illinois.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Dilger', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Bauer', 'Affiliation': 'Department of Animal Sciences, University of Illinois, Urbana, Illinois.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Broad', 'Affiliation': 'US Olympic and Paralympic Committee, Chula Vista, California.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana, Illinois.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00567.2019']
450,30274727,"Process Evaluation of a Policy, Systems, and Environmental Change Intervention in an Urban School District.","OBJECTIVE


To conduct a comprehensive process evaluation of a policy, systems, and environmental (PSE) change intervention.
DESIGN


Quasi-experimental, mixed methods.
SETTING


Low-income urban school district.
PARTICIPANTS


Fifth-grade students in 4 schools assigned to 2 intervention and 2 comparison schools (intervention, n = 142; comparison, n = 170).
INTERVENTION


Both groups received a nutrition curriculum delivered by classroom teachers. Intervention schools also received 10 PSE lessons taught by paraprofessional educators.
MAIN OUTCOME MEASURES


Quantitative data were obtained from fidelity and observation checklists, grading rubrics and self-reported student surveys. Focus group and interviews provided qualitative data. Quantitative measures included assessments of PSE and fruit and vegetable knowledge, as well as assessment of times fruits and vegetables (FV) were consumed yesterday.
ANALYSES


Qualitative data were analyzed using inductive content analysis. Quantitative data were analyzed using repeated measures analysis of variance and analysis of co-variance.
RESULTS


Fidelity, dose, reach, and acceptance of PSE intervention were high; students felt more empowered, although PSE lessons were considered lengthy and complicated. Intervention PSE and FV knowledge scores were significantly higher than comparison scores (F 37.56 , P < .001; and F 3.94 , P < .05, respectively). However, issues in communication were identified between school staff and researchers.
CONCLUSIONS AND IMPLICATIONS


Policy, systems, and environmental classroom interventions commented on the differences between quantitative and qualitative assessments, and this suggests the need for more sensitive quantitative assessments. Future research should look at long-term outcomes as this study only looked at short-term outcomes.",2019,"Intervention PSE and FV knowledge scores were significantly higher than comparison scores (F 37.56 , P < .001; and F 3.94 , P < .05, respectively).","['Fifth-grade students in 4 schools assigned to 2 intervention and 2 comparison schools (intervention, n\u202f=\u202f142; comparison, n\u202f=\u202f170', 'Low-income urban school district', 'Urban School District']","['nutrition curriculum delivered by classroom teachers', 'Environmental Change Intervention', '10 PSE lessons taught by paraprofessional educators']","['Fidelity, dose, reach, and acceptance of PSE intervention', 'fidelity and observation checklists, grading rubrics and self-reported student surveys', 'Intervention PSE and FV knowledge scores', 'PSE and fruit and vegetable knowledge, as well as assessment of times fruits and vegetables (FV']","[{'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0238296,"Intervention PSE and FV knowledge scores were significantly higher than comparison scores (F 37.56 , P < .001; and F 3.94 , P < .05, respectively).","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Lepe', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Providence, RI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Goodwin', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Providence, RI.'}, {'ForeName': 'Katie T', 'Initials': 'KT', 'LastName': 'Mulligan', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Providence, RI.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Balestracci', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Providence, RI.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sebelia', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Providence, RI. Electronic address: sebelia@uri.edu.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Greene', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Providence, RI.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.07.017']
451,32118765,Cricothyroidotomy needle length is associated with posterior tracheal wall injury: A randomized crossover simulation study (CONSORT).,"BACKGROUND


Cricothyroidotomy is the final strategy in the ""cannot intubate, cannot oxygenate"" scenario, but half of needle cricothyroidotomy attempts result in failure. The most frequent complication in needle cricothyroidotomy is posterior tracheal wall injury. We hypothesized that needle length is related to posterior wall injury and compared needle cricothyroidotomy with a commercial kit to a modified shorter needle to evaluate success and posterior wall injury rates.
METHODS


The commercial kit has a needle stopper to prevent posterior wall injury, with a penetrating length of 25 mm. We made long stopper to shorten the length by 5 mm (net 20 mm penetrating length). Residents were recruited, received a lecture about cricothyroidotomy and practiced needle cricothyroidotomy using the commercial kit on a simulator. They then performed cricothyroidotomy using the commercial kit or the shorter needle on an ex-vivo porcine larynx covered with artificial skin. An intra-tracheal endoscope recorded the procedure. The video was evaluated for success/failure or posterior wall injury by independent evaluators. Larynxes with a distance from the outer surface to the inner lumen exceeding 13 mm were excluded. The distance in each larynx was measured by dissection after the study. Success and posterior wall injury rates were analyzed using Fisher exact test (P < .05 was statistically significant).
RESULTS


Forty-seven residents participated in the study. Data for two residents were excluded. There was no statistically significant difference in success rate between the commercial kit (100%, 45/45) and the shorter needle (91%, 41/45, P = .12). Failure was defined if the needle tip did not reach the lumen in four trials. Cannulated but complicated by posterior wall injury occurred in 33% (15/45) with the commercial kit and 5% (2/43) with the shorter needle (P < .01).
CONCLUSION


During needle cricothyroidotomy, force is needed for the needle to penetrate the cricothyroid ligament. The advancing needle sometimes cannot be stopped after penetrating the cricothyroid ligament. These data suggest that needle length is associated with posterior wall injury.",2020,"There was no statistically significant difference in success rate between the commercial kit (100%, 45/45) and the shorter needle (91%, 41/45, P = .12).","['posterior tracheal wall injury', 'Forty-seven residents participated in the study']","['Cricothyroidotomy needle length', 'lecture about cricothyroidotomy and practiced needle cricothyroidotomy using the commercial kit on a simulator']","['success rate', 'shorter needle', 'Success and posterior wall injury rates', 'posterior wall injury']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy (procedure)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0442071', 'cui_str': 'Posterior wall (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",47.0,0.0349306,"There was no statistically significant difference in success rate between the commercial kit (100%, 45/45) and the shorter needle (91%, 41/45, P = .12).","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Katayama', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Sinkawa, Mitaka, Tokyo.'}, {'ForeName': 'Kunitaro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Sinkawa, Mitaka, Tokyo.'}, {'ForeName': 'Joho', 'Initials': 'J', 'LastName': 'Tokumine', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Sinkawa, Mitaka, Tokyo.'}, {'ForeName': 'Alan Kawarai', 'Initials': 'AK', 'LastName': 'Lefor', 'Affiliation': 'Department of Surgery, Jichi Medical University, Tochigi-ken, Japan.'}, {'ForeName': 'Harumasa', 'Initials': 'H', 'LastName': 'Nakazawa', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Sinkawa, Mitaka, Tokyo.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Jimbo', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Sinkawa, Mitaka, Tokyo.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yorozu', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Sinkawa, Mitaka, Tokyo.'}]",Medicine,['10.1097/MD.0000000000019331']
452,30291016,Findings From a Randomized Trial of Weight Gain Prevention Among Overweight Puerto Rican Young Adults.,"OBJECTIVE


Assess impact of multimodality weight gain prevention intervention.
METHODS


Randomized clinical trial among 39 overweight young Puerto Rico college students using 10 weekly peer-support sessions promoting dietary, physical activity, and other lifestyle changes enhanced by stress-reduction and mindfulness approaches. Body mass index (BMI) and self-reported behaviors were measured at baseline and at 10 weeks and 6 months after baseline.
RESULTS


At the completion of the intervention, BMIs in the experimental arm were 0.8 units lower than at baseline (z = -3.0; P = .008) and 1.2 lower at 6 months after baseline (z = -4.1; P < .001); BMIs in the control arm were 0.7 higher (z = 2.7; P = .02) at 10 weeks and 0.8 higher at 6 months (z = 3.1; P = .005). Group × time interaction confirmed that BMI differed significantly over time between arms (χ 2  = 26.9; degrees of freedom = 2; P < .001). Analysis of behavioral changes was mostly inconclusive although the experimental arm reported a considerable increase in walking at 10 weeks. Qualitative data suggested that yoga and mindfulness components were particularly useful for motivating participants to maintain healthier lifestyle patterns.
CONCLUSIONS


Body mass index in the experimental arm decreased at the end of intervention and was maintained at 6 months' follow-up.",2019,"At the completion of the intervention, BMIs in the experimental arm were 0.8 units lower than at baseline (z = -3.0; P = .008) and 1.2 lower at 6 months after baseline (z = -4.1; P < .001); BMIs in the control arm were 0.7 higher (z = 2.7; P = .02) at 10 weeks and 0.8 higher at 6 months (z = 3.1; P = .005).","['39 overweight young Puerto Rico college students using 10 weekly', 'Overweight Puerto Rican Young Adults']","['peer-support sessions promoting dietary, physical activity, and other lifestyle changes enhanced by stress-reduction and mindfulness approaches', 'multimodality weight gain prevention intervention', 'Weight Gain Prevention']","['Body mass index (BMI) and self-reported behaviors', 'BMI', 'BMIs']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",39.0,0.0863953,"At the completion of the intervention, BMIs in the experimental arm were 0.8 units lower than at baseline (z = -3.0; P = .008) and 1.2 lower at 6 months after baseline (z = -4.1; P < .001); BMIs in the control arm were 0.7 higher (z = 2.7; P = .02) at 10 weeks and 0.8 higher at 6 months (z = 3.1; P = .005).","[{'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Halperin', 'Affiliation': 'Department of Health Behavior, School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; Robert Stempel College of Public Health and Social Work, Florida International University, FL. Electronic address: dhalpe@gmail.com.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Laux', 'Affiliation': 'North Carolina Translational and Clinical Sciences Institute, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'LeFranc-García', 'Affiliation': 'Sciences and Technology Department, Inter-American University of Puerto Rico, Ponce Campus, Ponce, Puerto Rico.'}, {'ForeName': 'Coloma', 'Initials': 'C', 'LastName': 'Araujo', 'Affiliation': 'Del Sur Farms, Ponce, Puerto Rico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, FL.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.07.014']
453,30395145,Effects of Fruit and Vegetable Feeding Messages on Mothers and Fathers: Interactions Between Emotional State and Health Message Framing.,"BACKGROUND


There is a pressing need to craft optimal public health messages promoting healthy feeding behaviors among parents. How these messages influence such feeding decisions are affected by multiple interactive factors including emotional states, message framing, and gender, but these factors have not been studied in the domain of parents' feeding of their children.
PURPOSE


To evaluate the role of message framing, emotional state, and parent gender on feeding choices that parents make for their children.
METHODS


In 2016-2017, 190 parents (126 mothers) of 4- to 7-year-old children were randomly assigned to an anger or fear emotion induction and read either a gain- or loss-framed message about the importance of children's fruit and vegetable (FV) consumption prior to choosing foods for their child from a virtual reality buffet.
RESULTS


Mothers in an angry state who received a gain-framed message chose relatively more FV for their child in the virtual buffet, F(3, 180) = 4.77, p = .027. However, fathers in this group did not feed more FV, but rather reported greater intention to improve future FV feeding, F(3, 180) = 4.91, p = .028.
CONCLUSIONS


Providing gain-framed messages to parents, particularly mothers, in an anger state may be most effective for motivating healthy dietary choices for children.
CLINICAL TRIAL INFORMATION


clinicaltrials.gov NCT02622035.",2019,"However, fathers in this group did not feed more FV, but rather reported greater intention to improve future FV feeding, F(3, 180) =","['Mothers and Fathers', 'In 2016-2017, 190 parents (126 mothers) of 4- to 7-year-old children']","['Fruit and Vegetable Feeding Messages', ""anger or fear emotion induction and read either a gain- or loss-framed message about the importance of children's fruit and vegetable (FV) consumption prior to choosing foods for their child from a virtual reality buffet""]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]",[],,0.0915627,"However, fathers in this group did not feed more FV, but rather reported greater intention to improve future FV feeding, F(3, 180) =","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Persky', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Ferrer', 'Affiliation': 'Basic Biobehavioral and Psychological Sciences Branch, Behavioral Research Program, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'Behavioral Research Program, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Goldring', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Cohen', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Kistler', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Haley E', 'Initials': 'HE', 'LastName': 'Yaremych', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, Bethesda, MD, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay088']
454,32046931,"Postpartum treatment with liraglutide in combination with metformin versus metformin monotherapy to improve metabolic status and reduce body weight in overweight/obese women with recent gestational diabetes: A double-blind, randomized, placebo-controlled study.","BACKGROUND


Gestational diabetes (GDM) imparts a high risk of developing diabetes postpartum. Insulin resistance appears to be the major contributor. Liraglutide, a glucagon-like peptide-1 analogue, improves peripheral glucose disposal and reduces body weight. We evaluated whether liraglutide in combination with metformin (MET-LIRA) is more effective than metformin monotherapy (MET-P) in improving insulin action and reducing body weight in overweight prior GDM (pGDM) women.
METHODS


Women (n = 153; body mass index (BMI) ≥25 kg/m 2 ; 18-45 y; GDM within 12 months) with metabolic abnormalities were randomized to MET-LIRA (MET-2000 mg, LIRA 1.8 mg SC QD) or MET-P (MET-2000 mg, Placebo QD). Study visits at baseline, 36-40, 56-60 and 80-84 weeks included body weight (BW), BMI, waist circumference and waist-to-height ratio measures. Oral glucose tolerance tests (OGTTs) were performed to assess glycemia, mean blood glucose (MBG), lipids, and compute insulin sensitivity and secretion measures.
FINDINGS


Seventy-two (47%) participants completed the study. MET-LIRA therapy was significantly better in improving MBG and insulin sensitivity indices [SI OGTT  MET-LIRA from 4.6 (3.2) to 5.9 (2.9) vs. MET-P 5.5 (3.0) to 5.4 (3.2)] and reducing BW and central adiposity [BMI MET-LIRA from 37.2 (8.3) to 33.8 (5.2) vs MET-P 33.8(5.2) to 32.8(6)]. MET-LIRA therapy but not MET-P decreased triglycerides (TRG) and TRG/high density lipoprotein cholesterol (HDL-C) ratios.
INTERPRETATION


MET-LIRA treatment demonstrated superior efficacy in correcting the metabolic status of pGDM women over 84 weeks of therapy. The addition of liraglutide to metformin therapy resulted in a more dramatic decrease in BW and central adiposity than metformin alone.
FUNDATION


Supported by an unrestricted investigator initiated grant from Novo Nordisk, Inc. awarded to K.E.H.
MEETING PRESENTATION


The results from preliminary analyses of this study were presented at 76th meeting of the American Diabetes Association, June 10-14, 2016 New Orleans, LA, and 77th meeting of the American Diabetes Association, June 9-12, 2017San Diego, CA.",2020,MET-LIRA therapy was significantly better in improving MBG and insulin sensitivity indices [SI OGTT  MET-LIRA from 4.6 (3.2) to 5.9 (2.9) vs. MET-P 5.5 (3.0) to 5.4 (3.2)] and reducing BW and central adiposity [BMI MET-LIRA from 37.2 (8.3) to 33.8 (5.2) vs MET-P 33.8(5.2) to 32.8(6)].,"['76th meeting of the American Diabetes Association, June 10-14, 2016 New Orleans, LA, and 77th meeting of the American Diabetes Association, June 9-12, 2017San Diego, CA', 'overweight prior GDM (pGDM) women', 'Women (n\u202f=\u202f153; body mass index (BMI) ≥25\u202fkg/m 2 ; 18-45 y; GDM within 12\u202fmonths) with metabolic abnormalities', 'overweight/obese women with recent gestational diabetes', 'Seventy-two (47%) participants completed the study']","['metformin', 'Liraglutide, a glucagon-like peptide-1 analogue', 'LIRA (MET-2000\u202fmg, LIRA 1.8\u202fmg SC QD) or MET-P (MET-2000\u202fmg, Placebo QD', 'liraglutide', 'metformin (MET-LIRA', 'placebo', 'metformin monotherapy']","['body weight (BW), BMI, waist circumference and waist-to-height ratio measures', 'glycemia, mean blood glucose (MBG), lipids, and compute insulin sensitivity and secretion measures', 'triglycerides (TRG) and TRG/high density lipoprotein cholesterol (HDL-C) ratios', 'BW and central adiposity', 'peripheral glucose disposal and reduces body weight', 'body weight', 'reducing BW and central adiposity', 'MBG and insulin sensitivity indices', 'metabolic status']","[{'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies (morphologic abnormality)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.0364488,MET-LIRA therapy was significantly better in improving MBG and insulin sensitivity indices [SI OGTT  MET-LIRA from 4.6 (3.2) to 5.9 (2.9) vs. MET-P 5.5 (3.0) to 5.4 (3.2)] and reducing BW and central adiposity [BMI MET-LIRA from 37.2 (8.3) to 33.8 (5.2) vs MET-P 33.8(5.2) to 32.8(6)].,"[{'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Elkind-Hirsch', 'Affiliation': ""Woman's Metabolic Clinic and Research Center, Woman's Hospital, Baton Rouge, LA 70817, USA. Electronic address: karen.elkind-hirsch@womans.org.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shaler', 'Affiliation': ""Woman's Metabolic Clinic and Research Center, Woman's Hospital, Baton Rouge, LA 70817, USA.""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': ""Woman's Metabolic Clinic and Research Center, Woman's Hospital, Baton Rouge, LA 70817, USA.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107548']
455,32057567,A circadian rhythm-related MTNR1B genetic variant (rs10830963) modulate body weight change and insulin resistance after 9 months of a high protein/low carbohydrate vs a standard hypocaloric diet.,"BACKGROUND & AIMS


The risk allele (G) of rs10830963 in the melatonin receptor 1 B (MTNR1B) gene presents an association with biochemical parameters and obesity. We study the effect of this SNP on insulin resistance and weight loss secondary to two hypocaloric diets.
METHODS


270 obese subjects were randomly allocated during 9 months (Diet HP: a high protein/low carbohydrate vs. Diet S: a standard severe hypocaloric diets). Anthropometric parameters, fasting blood glucose, C-reactive protein (CRP), insulin concentration, insulin resistance (HOMA-IR), lipid profile and adipocytokines levels were measured. Genotype of MTNR1B gene polymorphism (rs10830963) was evaluated.
RESULTS


All adiposity parameters, systolic blood pressure and leptin levels decreased in all subjects after both diets. This improvement of adiposity parameters was higher in non-G allele carriers than G allele carriers. After weight loss with Diet HP, (CC vs. CG + GG at 9 months); total cholesterol (delta: -9.9 ± 2.4 mg/dl vs. -4.8 ± 2.2 mg/dl:p < 0.05), LDL-cholesterol (delta: -8.3 ± 1.9 mg/dl vs. -5.1 ± 2.2 mg/dl: p < 0.05), insulin (delta: -4.7 ± 0.8 UI/L vs. -0.9 ± 1.0 UI/L: p < 0.05), triglycerides (delta: -17.7 ± 3.9 mg/dl vs. -6.1 ± 2.8 mg/dl: p < 0.05) and HOMA IR (delta: -0.8 ± 0.2 units vs. -0.2 ± 0.1 units: p < 0.05) improved only in no G allele carriers. After weight loss with Diet S in non G allele carriers, insulin levels (delta (CC vs. CG + GG): -3.4 ± 0.6 UI/L vs. -1.2 ± 0.4 UI/L: p < 0.05), triglycerides (delta: -29.2 ± 3.4 mg/dl vs. -8.2 ± 3.8 mg/dl: p < 0.05), HOMA-IR (delta (CC vs. CG + GG): -1.1 ± 0.2 units vs. -0.1 ± 0.1 units: p < 0.05), total cholesterol (delta: -15.9 ± 7.4 mg/dl vs. -5.8 ± 2.9 mg/dl:ns) and LDL-cholesterol (delta: -13.7 ± 5.9 mg/dl vs. -6.0 ± 2.9 mg/dl: ns) decreased, too.
CONCLUSIONS


our study detected a relationship of rs10830963 variant of MTNR1B gene with adiposity changes, cholesterol changes and insulin resistance modification induced by two different hypocaloric during 9 months.",2020,The risk allele (G) of rs10830963 in the melatonin receptor 1 B (MTNR1B) gene presents an association with biochemical parameters and obesity.,['270 obese subjects'],"['SNP', '9\u202fmonths (Diet HP: a high protein/low carbohydrate vs. Diet S: a standard severe hypocaloric diets']","['insulin resistance and weight loss', 'HOMA IR', 'adiposity parameters', 'Anthropometric parameters, fasting blood glucose, C-reactive protein (CRP), insulin concentration, insulin resistance (HOMA-IR), lipid profile and adipocytokines levels', 'All adiposity parameters, systolic blood pressure and leptin levels', 'body weight change and insulin resistance', 'total cholesterol', 'insulin levels', 'HOMA-IR', 'LDL-cholesterol', 'triglycerides']","[{'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",270.0,0.0188854,The risk allele (G) of rs10830963 in the melatonin receptor 1 B (MTNR1B) gene presents an association with biochemical parameters and obesity.,"[{'ForeName': 'Daniel Antonio', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. Electronic address: dadluis@yahoo.es.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107534']
456,30816148,Differential effects of a combination of Hibiscus sabdariffa and Lippia citriodora polyphenols in overweight/obese subjects: A randomized controlled trial.,"Plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic disturbances, both in cell and animal models, where most therapeutic approaches have failed. On the basis of previous research, a dietary supplement containing 500 mg of a combination of polyphenolic extracts from Lippia citriodora L. and Hibiscus sabdariffa L. (LC-HS), in the context of an equilibrated isocaloric diet, was evaluated in a double blind, placebo-controlled and randomized trial in 56 obese/overweight subjects for two months. Compared to controls, the consumption of the LC-HS polyphenols showed significant improvements in body weight, abdominal circumference of overweight subjects (-6.79 ± 0.80 cm in overweight LC-HS group vs -1.85 ± 0.83 cm in controls, p < 0.001) and body fat % (-1.33 ± 0.15% in overweight LC-HS group vs -0.66 ± 0.17% in controls, p < 0.05). Heart rate and systolic blood pressure also presented significant improvements in overweight LC-HS participants. However, changes were more modest in obese subjects. Further, LC-HS extract significantly reduced lipid content and increased AMPK activity in a hypertrophied adipocyte cell model. Therefore, consumption of 500 mg/day of LC-HS extracts enriched in polyphenols for two months in the context of an isocaloric diet by overweight subjects decreased symptoms associated to obesity-related diseases. Modulation of fat metabolism in adipose tissue, probably mediated by AMPK activation, is proposed as a molecular target to be explored in future research.",2019,"Compared to controls, the consumption of the LC-HS polyphenols showed significant improvements in body weight, abdominal circumference of overweight subjects (-6.79 ± 0.80 cm in overweight LC-HS group vs -1.85 ± 0.83 cm in controls, p < 0.001) and body fat % (-1.33 ± 0.15% in overweight LC-HS group vs -0.66 ± 0.17% in controls, p < 0.05).","['overweight/obese subjects', '56 obese/overweight subjects for two months', 'obese subjects', 'overweight LC-HS participants']","['Hibiscus sabdariffa and Lippia citriodora polyphenols', 'LC-HS extract', 'placebo', 'dietary supplement containing 500\u2009mg of a combination of polyphenolic extracts from Lippia citriodora L. and Hibiscus sabdariffa L. (LC-HS']","['lipid content and increased AMPK activity', 'Heart rate and systolic blood pressure', 'body weight, abdominal circumference of overweight subjects']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1207898', 'cui_str': 'Hibiscus sabdariffa'}, {'cui': 'C0331283', 'cui_str': 'Lippia'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]",56.0,0.0485615,"Compared to controls, the consumption of the LC-HS polyphenols showed significant improvements in body weight, abdominal circumference of overweight subjects (-6.79 ± 0.80 cm in overweight LC-HS group vs -1.85 ± 0.83 cm in controls, p < 0.001) and body fat % (-1.33 ± 0.15% in overweight LC-HS group vs -0.66 ± 0.17% in controls, p < 0.05).","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Herranz-López', 'Affiliation': 'Instituto de Investigación, Desarrollo e Innovación en Biotecnología Sanitaria de Elche (IDiBE) e Instituto de Biología Molecular y Celular (IBMC), Miguel Hernández University (UMH), Elche, 03202, Alicante, Spain.'}, {'ForeName': 'Mariló', 'Initials': 'M', 'LastName': 'Olivares-Vicente', 'Affiliation': 'Instituto de Investigación, Desarrollo e Innovación en Biotecnología Sanitaria de Elche (IDiBE) e Instituto de Biología Molecular y Celular (IBMC), Miguel Hernández University (UMH), Elche, 03202, Alicante, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Boix-Castejón', 'Affiliation': 'Institute of Bioengineering and Department of Applied Biology-Nutrition, University Miguel Hernandez, Alicante Institute for Health and Biomedical Research (ISABIAL-FISABIO Foundation), Alicante, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Caturla', 'Affiliation': 'Monteloeder S.L., Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Roche', 'Affiliation': 'Institute of Bioengineering and Department of Applied Biology-Nutrition, University Miguel Hernandez, Alicante Institute for Health and Biomedical Research (ISABIAL-FISABIO Foundation), Alicante, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Micol', 'Affiliation': 'Instituto de Investigación, Desarrollo e Innovación en Biotecnología Sanitaria de Elche (IDiBE) e Instituto de Biología Molecular y Celular (IBMC), Miguel Hernández University (UMH), Elche, 03202, Alicante, Spain. vmicol@umh.es.'}]",Scientific reports,['10.1038/s41598-019-39159-5']
457,32179906,Time to Symptom Resolution in Ulcerative Colitis With Multimatrix Mesalazine Treatment: A Pooled Analysis.,"BACKGROUND AND AIMS


Patients with ulcerative colitis [UC] require rapid and complete relief of symptoms, particularly stool frequency and rectal bleeding. The aim of this study was to determine time to symptom resolution in patients with UC during induction treatment with multimatrix mesalazine, and the proportion of patients remaining symptom-free and in endoscopic remission after 12 months of maintenance.
METHODS


A pooled analysis of 5 pivotal clinical trials, including >1300 patients, evaluating multimatrix mesalazine for treatment of mild-to-moderate active UC was conducted. Time to symptom resolution was defined as the period between first drug dosage date and first 3 consecutive days of induction therapy when the patient achieved a score of 0 [normal] on a modified UC Disease Activity Index for stool frequency and/or rectal bleeding.
RESULTS


Median [95% confidence interval] time to resolution of stool frequency was 52 (45-not estimable [NE]) days for placebo versus 38 [34-41] days for multimatrix mesalazine [combined dose groups, 2.4 or 4.8 g/day]; time to resolution of rectal bleeding was 35 [20-NE] days for placebo versus 15 [14-17] days for multimatrix mesalazine [combined dose groups]. Among those who achieved resolution of both stool frequency and rectal bleeding during induction, 67.4% maintained symptom scores of 0 at Month 12. No relationship was observed between rapidity of symptom resolution during induction treatment and achievement of endoscopic remission at Month 12.
CONCLUSIONS


Induction with multimatrix mesalazine provided rapid and prolonged symptom resolution in addition to endoscopic remission at Month 12.",2020,"No relationship was observed between rapidity of symptom resolution during induction treatment and achievement of endoscopic remission at Month 12.
","['Patients with ulcerative colitis (UC', 'patients with UC during induction treatment with multimatrix mesalazine and the proportion of patients remaining symptom-free and in endoscopic remission after 12 months of maintenance', '1300 patients evaluating multimatrix mesalazine for treatment of mild-to-moderate active UC was conducted']","['multimatrix mesalazine', 'placebo', 'Multimatrix Mesalazine']","['time to resolution of rectal bleeding', 'Time to symptom resolution', 'rapidity of symptom resolution', 'stool frequency and rectal bleeding', 'stool frequency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.103109,"No relationship was observed between rapidity of symptom resolution during induction treatment and achievement of endoscopic remission at Month 12.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Department of General Internal Medicine, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Hanauer', 'Affiliation': 'Digestive Health Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'IBD Center, Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Barrett', 'Affiliation': 'Shire, Basingstoke, UK.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjaa041']
458,32170307,A randomized controlled trial of CBT-I and PAP for obstructive sleep apnea and comorbid insomnia: main outcomes from the MATRICS study.,"STUDY OBJECTIVES


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


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


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


The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP.",2020,"No significant differences were found between the concomitant treatment arms versus PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint.","['people with obstructive sleep apnea (OSA) and comorbid insomnia', '121 adults with OSA and comorbid insomnia', 'Obstructive Sleep Apnea and Comorbid Insomnia']","['cognitive-behavior therapy for insomnia (CBT-I) and positive airway pressure (PAP', 'CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only', 'CBT-I and PAP']","['PAP adherence measures', 'PAP adherence across the first 90 days, with regular PAP use', 'adherence to PAP', 'Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI< 5), remission (ISI< 8), and response (ISI reduction from baseline > 7) serving as the clinical endpoints']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",121.0,0.0274862,"No significant differences were found between the concomitant treatment arms versus PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint.","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Ong', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Crawford', 'Affiliation': 'School of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Spencer C', 'Initials': 'SC', 'LastName': 'Dawson', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Louis F', 'Initials': 'LF', 'LastName': 'Fogg', 'Affiliation': 'College of Nursing, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Arlener D', 'Initials': 'AD', 'LastName': 'Turner', 'Affiliation': 'Center for Sleep and Brain Health, Department of Psychiatry, New York University, New York, NY.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Wyatt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Crisostomo', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Bantu S', 'Initials': 'BS', 'LastName': 'Chhangani', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Clete A', 'Initials': 'CA', 'LastName': 'Kushida', 'Affiliation': 'Division of Sleep Medicine, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Edinger', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, CO.'}, {'ForeName': 'Sabra M', 'Initials': 'SM', 'LastName': 'Abbott', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Roneil G', 'Initials': 'RG', 'LastName': 'Malkani', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Hrayr P', 'Initials': 'HP', 'LastName': 'Attarian', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",Sleep,['10.1093/sleep/zsaa041']
459,30787332,The neurobiology of placebo effects in sports: EEG frontal alpha asymmetry increases in response to a placebo ergogenic aid.,"The performance enhancing (ergogenic) placebo effect is elicited by an inert treatment and caused by positive affective appraisal of effort perception. Frontal alpha asymmetry (FAA) is a neurobiological correlate of positive affect. This study investigates, whether receiving an ergogenic placebo increases FAA and whether scores on the behavioral inhibition and activation system (BIS/BAS) scales affect this increase in FAA. Nineteen competitive male cyclists (37.26 ± 9.82 years) performed two maximum effort time trials. The first served as baseline for the second intervention time trial, where athletes received a placebo ergogenic aid or no treatment. We recorded FAA using EEG throughout all time trials and assessed BIS/BAS by questionnaire. There was a significant difference in change from baseline to intervention time trial in FAA during cycling in response to the placebo ergogenic aid compared to the control group. BIS, the BAS subscale Drive and the BAS-BIS difference score significantly co-varied with the change in FAA from baseline to intervention time trial in response to the placebo ergogenic aid. Administering a placebo ergogenic aid significantly influenced FAA during maximum effort cycling. Those athletes with a more pronounced goal seeking persistence and an overall dominance of the BAS over the BIS showed a significantly greater increase in FAA in response to a placebo ergogenic aid. A more pronounced BIS, however, seems to antagonize the increase in FAA associated with the ergogenic placebo response.",2019,There was a significant difference in change from baseline to intervention time trial in FAA during cycling in response to the placebo ergogenic aid compared to the control group.,['Nineteen competitive male cyclists (37.26\u2009±\u20099.82 years'],"['placebo ergogenic aid or no treatment', 'placebo ergogenic', 'ergogenic placebo']","['BIS, the BAS subscale Drive and the BAS-BIS difference score', 'FAA', 'behavioral inhibition and activation system (BIS/BAS) scales']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0222045'}]",19.0,0.161669,There was a significant difference in change from baseline to intervention time trial in FAA during cycling in response to the placebo ergogenic aid compared to the control group.,"[{'ForeName': 'Ellen K', 'Initials': 'EK', 'LastName': 'Broelz', 'Affiliation': 'University Hospital Tuebingen, Department of Psychosomatic Medicine and Psychotherapy, Osianderstr. 5, 72076, Tuebingen, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enck', 'Affiliation': 'University Hospital Tuebingen, Department of Psychosomatic Medicine and Psychotherapy, Osianderstr. 5, 72076, Tuebingen, Germany.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Niess', 'Affiliation': 'University Hospital Tuebingen, Department of Sports Medicine, Hoppe-Seyler-Str. 6, 72076, Tuebingen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schneeweiss', 'Affiliation': 'University Hospital Tuebingen, Department of Sports Medicine, Hoppe-Seyler-Str. 6, 72076, Tuebingen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Wolf', 'Affiliation': 'University of Tuebingen, Department of Psychology, Schleichstr. 4, 72076, Tuebingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'University Hospital Tuebingen, Department of Psychosomatic Medicine and Psychotherapy, Osianderstr. 5, 72076, Tuebingen, Germany. katja.weimer@uni-ulm.de.'}]",Scientific reports,['10.1038/s41598-019-38828-9']
460,30816124,Efficacy of Ologen matrix implant in Ahmed Glaucoma Valve Implantation.,"To determine the efficacy and safety of the Ologen collagen matrix adjunctive to Ahmed valve surgery. A randomized prospective multicentre clinical trial involving 58 patients that were followed for one year. Conventional surgery with Ahmed valve was performed in 31 eyes (Control group/CG) and in 27 Ologen (Ologen group/OG) was placed over the valve's plate. Baseline data: age, corneal thickness, intraocular pressure(IOP) and antiglaucoma medications.Postoperative data (days 1, 7 and months 1, 3, 6 and 12): IOP, antiglaucoma medications, visual acuity and complications were recorded. Frequency of hypertensive phase, complete and qualified success and survival rate were studied. No differences were found between CG and OG in the baseline data. The only difference between groups was a significantly lower IOP at day 1. No other differences were found in the follow-up between groups. Hypertensive phase (56%CG and 55%OG, p = 0,947), complete success 28,6%CG and 30,4%OG (p = 0,88) and qualified success 96,4% and 95,9%(p = 0,794). Survival rates at 1 year were 76,7%(CG) and 69,2%(OG)(p = 0,531). 38,7% of patients in the CG suffered some complication during follow-up and 61,5% in OG(p = 0,086). Ologen does not increase safety or efficacy in Ahmed valve surgery at one-year follow-up. This is the first study that shows no benefit of Ologen adjunctive to this surgery.",2019,"Survival rates at 1 year were 76,7%(CG) and 69,2%(OG)(p = 0,531).","['Ahmed Glaucoma Valve Implantation', '58 patients that were followed for one year']","['Ologen collagen matrix adjunctive to Ahmed valve surgery', 'Conventional surgery with Ahmed valve was performed in 31 eyes (Control group/CG', 'Ologen matrix implant']","['corneal thickness, intraocular pressure(IOP) and antiglaucoma medications', 'Frequency of hypertensive phase, complete and qualified success and survival rate', 'safety or efficacy', 'Survival rates', 'IOP, antiglaucoma medications, visual acuity and complications', 'efficacy and safety']","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0056114', 'cui_str': 'ologen'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C1444577', 'cui_str': 'Ahmed valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",58.0,0.0435735,"Survival rates at 1 year were 76,7%(CG) and 69,2%(OG)(p = 0,531).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Sastre-Ibáñez', 'Affiliation': 'Ophthalmology Department, Clínico San Carlos Hospital, Ophthalmology Department, Medicine Faculty, Complutense de Madrid University, and Instituto de Investigación Sanitaria del Clínico San Carlos Hospital (IdISSC), Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Cabarga', 'Affiliation': 'Ophthalmology Department, Ramón y Cajal Universitary Hospital, Madrid, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Canut', 'Affiliation': 'Glaucoma Department, Centro de Oftalmología Barraquer, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Pérez-Bartolomé', 'Affiliation': 'Ophthalmology Department, Clínico San Carlos Hospital, Ophthalmology Department, Medicine Faculty, Complutense de Madrid University, and Instituto de Investigación Sanitaria del Clínico San Carlos Hospital (IdISSC), Madrid, Spain.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Urcelay-Segura', 'Affiliation': 'Glaucoma Department, Gregorio Marañón Universitary Hospital, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cordero-Ros', 'Affiliation': 'Glaucoma Department, La Paz Universitary Hospital, Madrid, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'García-Feijóo', 'Affiliation': 'Ophthalmology Department, Clínico San Carlos Hospital, Ophthalmology Department, Medicine Faculty, Complutense de Madrid University, and Instituto de Investigación Sanitaria del Clínico San Carlos Hospital (IdISSC), Madrid, Spain.'}, {'ForeName': 'Jose María', 'Initials': 'JM', 'LastName': 'Martínez-de-la-Casa', 'Affiliation': 'Ophthalmology Department, Clínico San Carlos Hospital, Ophthalmology Department, Medicine Faculty, Complutense de Madrid University, and Instituto de Investigación Sanitaria del Clínico San Carlos Hospital (IdISSC), Madrid, Spain. martinezcasa@ya.com.'}]",Scientific reports,['10.1038/s41598-019-38656-x']
461,32023661,"Full-mouth disinfection effects on gingival fluid calprotectin, osteocalcin, and N-telopeptide of Type I collagen in severe periodontitis.","BACKGROUND


To compare the effects of full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD) on clinical, microbiological and biochemical parameters with conventional quadrant-wise scaling and root planning (Q-SRP) in severe chronic periodontitis.
METHODS


In the present prospective randomized controlled clinical trial with three parallel arms (#NCT04038801), 60 chronic periodontitis patients were randomly assigned to three study groups by a consecutive number in ascending order: FMD (n = 20), FMUD (n = 20), and Q-SRP (n = 20). All measurements and treatments were performed by the same investigator. At baseline, gingival crevicular fluid (GCF) and subgingival plaque were collected and clinical periodontal parameters were recorded. Ultrasonic debridement was completed within 24 hours in FMD and FMUD groups. Chlorhexidine gluconate was used for FMD. Q-SRP was performed by hand instruments per quadrant at 1-week-intervals. Clinical measurements and sampling were repeated at 1, 3, and 6 months after treatment. Real-time PCR was used for quantitative analysis of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Fusobacterium nucleatum, and total bacteria count. GCF Calprotectin, osteocalcin, and N-telopeptide of type I collagen (NTx) levels were analyzed by ELISA. The changes of GCF biomarker levels after treatment between groups were the primary outcomes.
RESULTS


No harm was observed. All treatment strategies resulted in significant improvements in all clinical parameters (P < 0.05), with no significant differences between study groups at all time-points (P ˃ 0.05). Aggregatibacter actinomycetemcomitans was significantly decreased in FMD compared to FMUD and Q-SRP at 6 months (P < 0.05). Although GCF NTx total amounts increased in all groups during the study period, this increase was less prominent in full-mouth groups at three time points after treatment (P < 0.05).
CONCLUSIONS


Present results represent the short-term effects. Full-mouth treatment approaches offered limited beneficial effects on microbiological and biochemical parameters over quadrant-wise approach. All three treatment strategies can be recommended in the management of severe chronic periodontitis.",2020,"All treatment strategies resulted in significant improvements in all clinical parameters (p<0.05), with no significant differences between study groups at all time-points (p˃0.05).","['60 chronic periodontitis patients', 'severe chronic periodontitis']","['Chlorhexidine gluconate', 'full-mouth disinfection', 'full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD', 'Ultrasonic debridement', 'FMUD', 'conventional quadrant-wise scaling and root planning (Q-SRP']","['GCF biomarker levels', 'gingival crevicular fluid (GCF) and subgingival plaque', 'GCF Calprotectin, osteocalcin and N-telopeptide of type', 'I collagen (NTx) levels', 'GCF NTx total amounts', 'Aggregatibacter actinomycetemcomitans', 'gingival crevicular fluid levels of calprotectin, osteocalcin and N-telopeptide of type I collagen']","[{'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque (disorder)'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0085488', 'cui_str': 'Haemophilus actinomycetemcomitans'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}]",60.0,0.0757924,"All treatment strategies resulted in significant improvements in all clinical parameters (p<0.05), with no significant differences between study groups at all time-points (p˃0.05).","[{'ForeName': 'Beral', 'Initials': 'B', 'LastName': 'Afacan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Çınarcık', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gürkan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Güven', 'Initials': 'G', 'LastName': 'Özdemir', 'Affiliation': 'Department of Biology, Basic and Industrial Microbiology Section, Faculty of Science, Ege University, Izmir, Turkey.'}, {'ForeName': 'Harika Atmaca', 'Initials': 'HA', 'LastName': 'İlhan', 'Affiliation': 'Department of Biology, Section of Molecular Biology, Faculty of Science and Letters, Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Caner', 'Initials': 'C', 'LastName': 'Vural', 'Affiliation': 'Department of Biology, Basic and Industrial Microbiology Section, Faculty of Science, Ege University, Izmir, Turkey.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Köse', 'Affiliation': 'Department of Biostatistics and Medical Informatics, Faculty of Medicine, Ege University, Izmir, Turkey.'}, {'ForeName': 'Gülnur', 'Initials': 'G', 'LastName': 'Emingil', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}]",Journal of periodontology,['10.1002/JPER.19-0445']
462,31162698,"The effectivness of a strengths-oriented therapeutic conversation intervention on perceived support, well-being and burden among family caregivers in palliative home-care.","AIMS


To evaluate the effectiveness of a two-session multicomponent family strengths- oriented therapeutic conversation intervention among family caregivers of an individual with advanced/final stage cancer during ongoing palliative home-care.
BACKGROUND


Family caregivers of patients in the advanced/final phases of cancer, experience multifaceted psychological distress and morbidity. Psychosocial interventions improve the well-being of family members who are caring for their close relative.
DESIGN


A pre-experimental design with a one-group pre-test/posttests measurements.
METHODS


Forty-eight family caregivers were assigned to receive two 60-90 min sessions of the intervention. The primary outcome was perceived emotional and cognitive support and psychological well-being, measured at baseline (T1). Then the participants were offered the first session of the intervention. About 1 week later, the second session was administered. The participants answered the same questionnaires again (T2) and then 2-4 weeks later (T3). The guideline; Criteria for Reporting Development and Evaluation of Complex Interventions 2, guided the reporting of the study.
RESULTS


Family caregivers reported significantly higher emotional and cognitive support post-intervention (T2) and at (T3). They also reported significantly reduced stress symptoms at (T3) and reduced caregiver burden post-intervention (T2) and at (T3).
CONCLUSION


The provision of the intervention contributed to extending knowledge about the usefulness of family conversations in the context of advanced/final stage cancer care.
IMPACT


There is a lack of knowledge about the benefit of therapeutic conversation interventions for family caregivers. The therapeutic conversation intervention offered, resulted in perceived support, decreased stress, and decreased caregiving demands among caregivers in palliative home-care.
TRIAL REGISTRATION NUMBER


ISRCTN 21786830.",2019,"The therapeutic conversation intervention offered, resulted in perceived support, decreased stress and decreased caregiving demands among caregivers in palliative home-care.","['family caregivers in palliative home-care', 'family members who are caring for their close relative', 'family caregivers of an individual with advanced/final stage cancer', 'Forty-eight family caregivers']","['strengths-oriented therapeutic conversation intervention', 'Psychosocial interventions', 'two-session multicomponent family strengths- oriented therapeutic conversation intervention']","['stress symptoms', 'emotional and cognitive support and psychological well-being, measured at baseline (T1', 'emotional and cognitive support post-intervention (T2) and (T3']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0557090', 'cui_str': 'Closest relatives (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",2.0,0.0369451,"The therapeutic conversation intervention offered, resulted in perceived support, decreased stress and decreased caregiving demands among caregivers in palliative home-care.","[{'ForeName': 'Asta B', 'Initials': 'AB', 'LastName': 'Petursdottir', 'Affiliation': 'Palliative Home-Care Unit, Landspitali - The National University Hospital of Iceland, Kopavogur, Iceland.'}, {'ForeName': 'Erla Kolbrun', 'Initials': 'EK', 'LastName': 'Svavarsdottir', 'Affiliation': 'School of Health Sciences, University of Iceland, Reykjavík, Iceland.'}]",Journal of advanced nursing,['10.1111/jan.14089']
463,32166534,Administration of the vasopressin analog desmopressin for the management of bleeding in rectal cancer patients: results of a phase I/II trial.,"Purpose The vasopressin analog desmopressin (dDAVP) is known to increase plasma levels of hemostatic factors, and preclinical studies in colorectal cancer models have demonstrated that it hampers tumor vascularization and metastatic progression. We evaluated safety and preliminary efficacy of dDAVP in rectal cancer patients with bleeding, before receiving specific oncologic treatment with surgery, chemotherapy and/or radiotherapy. Methods Patients with rectal cancer having moderate or severe rectal bleeding were enrolled in an open-label, dose-finding trial. Intravenous infusions of dDAVP were administered during two consecutive days in doses from 0.25 to 2.0 µg/kg, using single or twice daily regimen. Bleeding was graded using a score based on the Chutkan scale and tumor perfusion was evaluated by dynamic contrast-enhanced magnetic resonance imaging. Results The trial accrued a total of 32 patients. Dose-limiting toxicity occurred in patients receiving 1 µg/kg or higher. The most prominent treatment-related severe adverse event was hyponatremia. Most patients receiving the maximum tolerated dose of 0.5 µg/kg showed at least a partial hemostatic response and 58% developed a complete response with absence of bleeding at day 4 and/or at the last follow-up at day 14. Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment. Conclusions dDAVP appeared as a promising hemostatic agent in rectal cancer patients with bleeding. Randomized clinical trials to confirm its effectiveness are warranted.Clinical trial registration www.clinicaltrials.gov NCT01623206.",2020,Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment.,"['rectal cancer patients', 'rectal cancer patients with bleeding, before receiving specific oncologic treatment with surgery', 'rectal cancer patients with bleeding', 'Methods Patients with rectal cancer having moderate or severe rectal bleeding', '32 patients']","['dDAVP', 'chemotherapy and/or radiotherapy', 'vasopressin analog desmopressin', 'vasopressin analog desmopressin (dDAVP']","['partial hemostatic response', 'Bleeding', 'complete response with absence of bleeding', 'Tumor perfusion', 'Dose-limiting toxicity']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0267596', 'cui_str': 'Rectal hemorrhage (disorder)'}]","[{'cui': 'C0701195', 'cui_str': 'DDAVP'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",32.0,0.0550471,Tumor perfusion was decreased in two-thirds of patients after dDAVP treatment.,"[{'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Iseas', 'Affiliation': 'Oncology Unit, Gastroenterology Hospital Bonorino Udaondo, Buenos Aires, Argentina.'}, {'ForeName': 'Enrique L', 'Initials': 'EL', 'LastName': 'Roca', 'Affiliation': 'Oncology Unit, Gastroenterology Hospital Bonorino Udaondo, Buenos Aires, Argentina.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Clinical Oncology, Alexander Fleming Institute, Buenos Aires, Argentina.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eleta', 'Affiliation': 'Onco-imaging Area, Imaxe Center for Diagnostic, Buenos Aires, Argentina.'}, {'ForeName': 'Analia', 'Initials': 'A', 'LastName': 'Sanchez-Luceros', 'Affiliation': 'Thrombosis and Hemostasis Department, IMEX and IIHEMA, National Academy of Medicine, Buenos Aires, Argentina.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Di Leo', 'Affiliation': 'Elea-Phoenix Laboratories, Los Polvorines, Argentina.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Tinelli', 'Affiliation': 'Elea-Phoenix Laboratories, Los Polvorines, Argentina.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Fara', 'Affiliation': 'Elea-Phoenix Laboratories, Los Polvorines, Argentina.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Spitzer', 'Affiliation': 'Elea-Phoenix Laboratories, Los Polvorines, Argentina.'}, {'ForeName': 'Ignacio A', 'Initials': 'IA', 'LastName': 'Demarco', 'Affiliation': 'Chemo-Romikin, Buenos Aires, Argentina.'}, {'ForeName': 'Giselle V', 'Initials': 'GV', 'LastName': 'Ripoll', 'Affiliation': 'Laboratory of Molecular Oncology, National University of Quilmes, Bernal, Argentina.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pifano', 'Affiliation': 'Laboratory of Molecular Oncology, National University of Quilmes, Bernal, Argentina.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Garona', 'Affiliation': 'Laboratory of Molecular Oncology, National University of Quilmes, Bernal, Argentina.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Alonso', 'Affiliation': 'Laboratory of Molecular Oncology, National University of Quilmes, Bernal, Argentina. dfalonso@unq.edu.ar.'}]",Investigational new drugs,['10.1007/s10637-020-00914-5']
464,31841106,"Bioequivalence of two tacrolimus 1-mg formulations under fasting conditions in healthy subjects: A randomized, two-period crossover trial
.","OBJECTIVE


The present study compared the pharmacokinetics of two (1 mg) tacrolimus formulations (test (generic from Panacea) and reference (innovator from Astellas)) after a single-dose administration as per the European Medicine Agency (EMA) guidelines to grant marketing authorization.
MATERIALS AND METHODS


This study was a randomized, open-label, balanced, two-treatment, two-period, two-sequences, single-dose, truncated-area, crossover design with a washout period of 19 days between the phases. Healthy subjects aged 18 - 45 years (both inclusive) were included. Eligible subjects received a single oral dose of 5 × 1-mg capsule of tacrolimus either test or reference formulation. Blood samples were collected until 72.00 hours postdose, and peak concentration (C max ) and area under the curve (AUC 0-72 ) were evaluated in whole blood using validated LC-MS/MS. Safety was also assessed in each period.
RESULTS


Of 56 subjects enrolled, 52 completed both study periods. The arithmetic mean (SD) C max  for the reference and test formulations was 40.62 (11.30) and 46.20 (10.73) ng/mL, and AUC 0-72  was 348.34 (156.41) and 361.04 (158.71) ng×h/mL, respectively. The geometric least square mean ratio (90% confidence interval (CI)) was 115.07% (90% CI: 109.81, 120.59) for C max  and 103.78 (90% CI: 97.40, 110.58) for AUC 0-72 , which fell within the acceptance range as per EMA guidelines for narrow therapeutic index drugs (C max : 80.00 - 125.00%; AUC: 90.00 - 111.11%). No serious adverse event was observed.
CONCLUSION


The generic tacrolimus was bioequivalent to the reference formulation, was well tolerated, and provides a well-acceptable alternative to the reference drug. Switching treatment to generic tacrolimus medication may reduce the cost and economic burden of treating transplanted patients.",2020,"The generic tacrolimus was bioequivalent to the reference formulation, was well tolerated, and provides a well-acceptable alternative to the reference drug.","['56 subjects enrolled, 52 completed both study periods', 'Healthy subjects aged 18\xa0-\xa045 years (both inclusive) were included', 'healthy subjects']","['tacrolimus 1-mg formulations', 'tacrolimus formulations (test (generic from Panacea) and reference (innovator from Astellas', 'single oral dose of 5 × 1-mg capsule of tacrolimus either test or reference formulation']","['arithmetic mean (SD) C max  for the reference and test formulations', 'Safety', 'geometric least square mean ratio', 'peak concentration (C max ) and area under the curve (AUC 0-72 ', 'Blood samples']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0990468', 'cui_str': 'Tacrolimus 1 MG'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",56.0,0.143661,"The generic tacrolimus was bioequivalent to the reference formulation, was well tolerated, and provides a well-acceptable alternative to the reference drug.","[{'ForeName': 'Lalitendu', 'Initials': 'L', 'LastName': 'Mohanty', 'Affiliation': ''}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Bhushan', 'Affiliation': ''}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Rüttger', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203534']
465,31050156,"Response of 1,5-anhydroglucitol level to intensive glucose- and blood-pressure lowering interventions, and its associations with clinical outcomes in the ADVANCE trial.","AIMS


To evaluate 1,5-anhydroglucitol (1,5-AG) according to clinical outcomes and assess the effects of glucose- and blood pressure-lowering interventions on change in 1,5-AG levels in people with type 2 diabetes.
METHODS


We measured 1,5-AG in 6826 stored samples at baseline and in a random subsample of 684 participants at the 1-year follow-up visit in the ADVANCE trial. We examined baseline 1,5-AG [< 39.7, 39.7-66.2, ≥ 66.2 μmol/L (<6, 6-10, ≥10 μg/mL)] and microvascular and macrovascular events and mortality using Cox regression models during 5 years of follow-up. Using an intention-to-treat approach, we examined 1-year change in 1,5-AG (mean and percent) in response to the glucose- and blood pressure-lowering interventions in the subsample.
RESULTS


Low 1,5-AG level [<39.7 μmol/L vs ≥ 66.2 μmol/L (<6 μg/mL vs ≥10 μg/mL)] was associated with microvascular events (hazard ratio 1.28, 95% confidence interval 1.03-1.60) after adjustment for risk factors and baseline glycated haemoglobin (HbA1c); however, the associations for macrovascular events and mortality were not independent of HbA1c. The glucose-lowering intervention was associated with a significant 1-year increase in 1,5-AG (vs standard control) of 6.69 μmol/L (SE 2.52) [1.01 μg/mL (SE 0.38)], corresponding to an 8.26% (SE 0.10%) increase from baseline. We also observed an increase in 1,5-AG of similar magnitude in response to the blood pressure intervention independent of the glucose-lowering effect.
CONCLUSIONS


Our results suggest that 1,5-AG is a marker of risk in adults with type 2 diabetes, but only for microvascular events independently of HbA1c. We found that 1,5-AG was improved (increased) in response to an intensive glucose-lowering intervention, although the independent effect of the blood pressure-lowering intervention on 1,5-AG suggests potential non-glycaemic influences.",2019,"/mL)] was associated with microvascular events (hazard ratio 1.28, 95% confidence interval 1.03-1.60) after adjustment for risk factors and baseline glycated haemoglobin (HbA1c); however, the associations for macrovascular events and mortality were not independent of HbA1c.","['adults with type 2 diabetes', 'people with type 2 diabetes', '6826 stored samples at baseline and in a random subsample of 684 participants at the 1-year follow-up visit in the ADVANCE trial']","['glucose- and blood pressure-lowering interventions', 'intensive glucose- and blood-pressure lowering interventions']","['microvascular and macrovascular events and mortality using Cox regression models', 'macrovascular events and mortality', '1,5-AG', 'microvascular events', '1,5-AG levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.102038,"/mL)] was associated with microvascular events (hazard ratio 1.28, 95% confidence interval 1.03-1.60) after adjustment for risk factors and baseline glycated haemoglobin (HbA1c); however, the associations for macrovascular events and mortality were not independent of HbA1c.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Selvin', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'John William', 'Initials': 'JW', 'LastName': 'McEvoy', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Centre/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Lazo', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Hamet', 'Affiliation': ""Department of Medicine, Centre Hospitalier de I'Universite de Montreal (CHUM) | CHUM, Montreal, Quebec, Canada.""}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Diabetes Department, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Marre', 'Affiliation': 'Department of Diabetology, Endocrinology, and Nutrition, Assistance Publique-Hôpitaux deParis, Bichat Hospital, France.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Institute of Cardiovascular Sciences, University College London and National Institute of Health Research University College London Hospitals Biomedical Research Centre, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'The University of Melbourne and Royal Melbourne Hospital, Victoria, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13755']
466,31225666,A randomized controlled trial testing a decision support intervention for older patients with advanced kidney disease.,"AIM


To evaluate the effectiveness of a decision support intervention (OPTIONS) in facilitating the older person with advanced kidney disease to make a treatment choice.
DESIGN


Pragmatic randomized controlled trial.
METHODS


People aged ≥70 years with advanced kidney disease (eGFR ≤20 ml/min/1.73m 2  ) who had not made a decision about treatment options and who were not eligible for a kidney transplant were recruited between March 2015 and March 2016. Participants were randomly allocated to receive the OPTIONS (N = 16) or standard care (N = 21). OPTIONS is a 4-week nurse-delivered intervention. Primary outcomes were decision conflict and decision regret, the secondary outcomes were knowledge of risk and benefits of dialysis and health-related quality of life. The usefulness of OPTIONS was also evaluated.
RESULTS


There were no differences between the intervention and standard care groups at baseline. At T1, there were no significant differences in decision conflict and decision regret although the intervention group had lower decisional conflict at T2. The decision support intervention was able to significantly improve the participants' knowledge score in the intervention group. There were no observable differences between groups for health-related quality of life physical and mental health component summary scores. OPTIONS was helpful in preparing participants in making a treatment decision.
CONCLUSION


OPTIONS, a decision support intervention, increased a person's knowledge of the benefits and risks of dialysis and can be used to facilitate shared decision-making with older adults with advanced stages of kidney disease.
IMPACT


Strategies to improve shared decision-making between older people with advanced stages of kidney disease and their clinicians are crucial for patient autonomy in a population where this may not be common practice. The decision support intervention- OPTIONS demonstrated significant improvement in patient knowledge about different treatment pathways. OPTIONS provides a structured and evidence-based approach to support shared decision-making for this population.
TRIAL REGISTRATION


ACTRN 12614001090606 Registered 14/10/2014.",2019,"At T1, there were no significant differences in decision conflict and decision regret although the intervention group had lower decisional conflict at T2.","['older patients with advanced kidney disease', 'older people with advanced stages of kidney disease', 'older adults with advanced stages of kidney disease', 'older person with advanced kidney disease', 'People aged ≥ 70 years with advanced kidney disease (eGFR ≤ 20 mL/min/1.73m 2  ) who had not made a decision regarding treatment options and who were not eligible for a kidney transplant were recruited between March 2015 and March 2016']","['decision support intervention', 'standard care']","['decisional conflict', 'health-related quality of life physical and mental health component summary scores', 'decision conflict and decision regret, the secondary outcomes were knowledge of risk and benefits of dialysis and health-related quality of life', 'decision conflict and decision regret', ""participants' knowledge score""]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",,0.0992461,"At T1, there were no significant differences in decision conflict and decision regret although the intervention group had lower decisional conflict at T2.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Qld, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Gardner', 'Affiliation': 'School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Qld, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bonner', 'Affiliation': 'School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Qld, Australia.'}]",Journal of advanced nursing,['10.1111/jan.14112']
467,31241194,"Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial.","AIMS


To evaluate a deep oropharyngeal suction intervention (NO-ASPIRATE) in intubated patients on microaspiration, ventilator-associated events and clinical outcomes.
DESIGN


Prospective, two-group, single-blind, randomized clinical trial.
METHODS


The study was conducted between 2014 - 2017 in 513 participants enroled within 24 hr of intubation and randomized into NO-ASPIRATE or usual care groups. Standard oral care was provided to all participants every 4 hr and deep oropharyngeal suctioning was added to the NO-ASPIRATE group. Oral and tracheal specimens were obtained to quantify α-amylase as an aspiration biomarker.
RESULTS


Data were analysed for 410 study completers enrolled at least 36 hr: NO-ASPIRATE (N = 206) and usual care (N = 204). Percent of tracheal specimens positive for α-amylase, mean tracheal α-amylase levels over time and ventilator-associated events were not different between groups. The NO-ASPIRATE group had a shorter hospital length of stay and a subgroup with moderate aspiration at baseline had significantly lower α-amylase levels across time.
CONCLUSION


Hospital length of stay was shorter in the NO-ASPIRATE group and a subgroup of intervention participants had lower α-amylase across time. Delivery of standardized oral care to all participants may have been an intervention itself and possibly associated with the lack of significant findings for most outcomes.
IMPACT


This trial compared usual care to oral care with a deep suctioning intervention on microaspiration and ventilator-associated events, as this has not been systematically studied. Further research on the usefulness of α-amylase as an aspiration biomarker and the role of oral suctioning, especially for certain populations, is indicated.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT02284178.",2019,"CONCLUSION


Hospital length of stay was shorter in the NO-ASPIRATE group and a subgroup of intervention participants had lower α-amylase across time.","['2014 - 2017 in 513 participants enrolled within 24 hours of intubation and randomized into NO-ASPIRATE or usual care groups', '410 study completers enrolled at least 36 hours: NO-ASPIRATE (N=206) and usual care (N=204', 'intubated patients on microaspiration, ventilator-associated events and clinical outcomes']","['Deep Oropharyngeal Suctioning', 'deep oropharyngeal suction intervention (NO-ASPIRATE', 'deep suctioning intervention']","['shorter hospital length of stay', 'Hospital length of stay', 'Microaspiration, Ventilator Events, and Clinical Outcomes', 'tracheal specimens positive for α-amylase, mean tracheal α-amylase levels']","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0278384', 'cui_str': 'Oropharyngeal suctioning (procedure)'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",513.0,0.0751328,"CONCLUSION


Hospital length of stay was shorter in the NO-ASPIRATE group and a subgroup of intervention participants had lower α-amylase across time.","[{'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Sole', 'Affiliation': 'University of Central Florida College of Nursing, Orlando, Florida.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Talbert', 'Affiliation': 'University of Central Florida College of Nursing, Orlando, Florida.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Statistics, University of Central Florida College of Sciences, Orlando, Florida.'}, {'ForeName': 'Daleen', 'Initials': 'D', 'LastName': 'Penoyer', 'Affiliation': 'Center for Nursing Research and Advanced Nursing Practice, Orlando Health, Orlando, Florida.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Pediatric Specialty Diagnostic Laboratory, Arnold Palmer Hospital, Orlando Health, Orlando, Florida.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'Center for Nursing Research and Advanced Nursing Practice, Orlando Health, Orlando, Florida.'}, {'ForeName': 'Kimberly Paige', 'Initials': 'KP', 'LastName': 'Emery', 'Affiliation': 'University of Central Florida College of Nursing, Orlando, Florida.'}, {'ForeName': 'Aurea', 'Initials': 'A', 'LastName': 'Middleton', 'Affiliation': 'Center for Nursing Research and Advanced Nursing Practice, Orlando Health, Orlando, Florida.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Deaton', 'Affiliation': 'Center for Nursing Research and Advanced Nursing Practice, Orlando Health, Orlando, Florida.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Abomoelak', 'Affiliation': 'Pediatric Specialty Diagnostic Laboratory, Arnold Palmer Hospital, Orlando Health, Orlando, Florida.'}, {'ForeName': 'Chirajyoti', 'Initials': 'C', 'LastName': 'Deb', 'Affiliation': 'Pediatric Specialty Diagnostic Laboratory, Arnold Palmer Hospital, Orlando Health, Orlando, Florida.'}]",Journal of advanced nursing,['10.1111/jan.14142']
468,31856887,"A 2 × 2 factorial, randomised, open-label trial to determine the clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care over 52 weeks in adults with bronchiectasis: a protocol for the CLEAR clinical trial.","BACKGROUND


Current guidelines for the management of bronchiectasis (BE) highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum removal as part of standard care. We hypothesise that mucoactive agents (HTS or carbocisteine, or a combination) are effective in reducing exacerbations over a 52-week period, compared to usual care.
METHODS


This is a 52-week, 2 × 2 factorial, randomized, open-label trial to determine the clinical effectiveness and cost effectiveness of HTS 6% and carbocisteine for airway clearance versus usual care - the Clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care (CLEAR) trial. Patients will be randomised to (1) standard care and twice-daily nebulised HTS (6%), (2) standard care and carbocisteine (750 mg three times per day until visit 3, reducing to 750 mg twice per day), (3) standard care and combination of twice-daily nebulised HTS and carbocisteine, or (4) standard care. The primary outcome is the mean number of exacerbations over 52 weeks. Key inclusion criteria are as follows: adults with a diagnosis of BE on computed tomography, BE as the primary respiratory diagnosis, and two or more pulmonary exacerbations in the last year requiring antibiotics and production of daily sputum.
DISCUSSION


This trial's pragmatic research design avoids the significant costs associated with double-blind trials whilst optimising rigour in other areas of trial delivery. The CLEAR trial will provide evidence as to whether HTS, carbocisteine or both are effective and cost effective for patients with BE.
TRIAL REGISTRATION


EudraCT number: 2017-000664-14 (first entered in the database on 20 October 2017). ISRCTN.com, ISRCTN89040295. Registered on 6 July/2018. Funder: National Institute for Health Research, Health Technology Assessment Programme (15/100/01).
SPONSOR


Belfast Health and Social Care Trust. Ethics Reference Number: 17/NE/0339. Protocol version: v3.0 Final_14052018.",2019,"The CLEAR trial will provide evidence as to whether HTS, carbocisteine or both are effective and cost effective for patients with BE.
","['adults with bronchiectasis', 'patients with BE', 'Key inclusion criteria are as follows: adults with a diagnosis of BE on computed tomography, BE as the primary respiratory diagnosis, and two or more pulmonary exacerbations in the last year requiring antibiotics and production of daily sputum', '2017-000664-14 (first entered in the database on 20 October 2017']","['HTS 6% and carbocisteine', 'standard care and twice-daily nebulised HTS (6%), (2) standard care and carbocisteine', 'standard care and combination of twice-daily nebulised HTS and carbocisteine, or (4) standard care', 'hypertonic saline (HTS 6%) and carbocisteine', 'mucoactive agents (HTS or carbocisteine, or a combination', 'hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care']",['mean number of exacerbations'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033268'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0006992', 'cui_str': 'Carbocysteine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.141108,"The CLEAR trial will provide evidence as to whether HTS, carbocisteine or both are effective and cost effective for patients with BE.
","[{'ForeName': 'Judy Martina', 'Initials': 'JM', 'LastName': 'Bradley', 'Affiliation': ""Wellcome-Wolfson Institute For Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK. judy.bradley@qub.ac.uk.""}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': ""Wellcome-Wolfson Institute For Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': ""O'Neill"", 'Affiliation': 'Centre for Health and Rehabilitation Technologies (CHaRT), Institute of Nursing and Health Research, Ulster University, Newtownabbey, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ferguson', 'Affiliation': 'Northern Ireland Clinical Research Network, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Northern Ireland Methodology Hub, Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Carroll', 'Affiliation': 'Southampton University Hospitals NHS Trust, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'De Soyza', 'Affiliation': 'NIHR Biomedical research centre (BRC) for Aging, Institute of Cellular Medicine, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Duckers', 'Affiliation': 'Cardiff and Vale University Health Board, University Hospital Llandough, Penarth, UK.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Loebinger', 'Affiliation': 'Faculty of Medicine, National Heart and Lung Institute, Imperial College and Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Copeland', 'Affiliation': 'PCD Family Support Group, Ciliopathy Alliance, London, UK.'}, {'ForeName': 'Evie', 'Initials': 'E', 'LastName': 'Gardner', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'McGuire', 'Affiliation': 'Department of Health Policy, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Boyle', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'McKinney', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Dickson', 'Affiliation': 'Northern Ireland Clinical Trials Unit, Belfast Health and Social Care Trust, Belfast, UK.'}, {'ForeName': 'Danny F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome-Wolfson Institute For Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Elborn', 'Affiliation': ""Wellcome-Wolfson Institute For Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3766-9']
469,31222832,"Capnography monitoring of non-anesthesiologist provided sedation during percutaneous endoscopic gastrostomy placement: A prospective, controlled, randomized trial.","BACKGROUND AND AIM


A number of studies were able to show a reduction of hypoxemia episodes during procedural sedation through the use of capnography (CA). The present study investigates the number of episodes of hypoxemia during percutaneous endoscopic gastrostomy (PEG) placement with propofol sedation comparing standard monitoring (SM) versus SM with additional CA surveillance.
METHODS


In this single center randomized controlled trial, 150 patients were prospectively randomized 1:1 in either the SM group or the CA group after stratification for ASA class, PEG method (push or pull method), presence of head and neck tumor, and tracheostomy. CA analysis was performed for all patients but was blinded for the endoscopic team in the SM group.
RESULTS


In the SM group, 57% episodes of hypoxemia (SpO 2   < 90% for > 15 s) and 41% episodes of severe hypoxemia (SpO 2   < 85% for > 15 s) were observed in comparison with 28% and 20% in the CA group, respectively. Odds ratios for hypoxemia and severe hypoxemia were 0.29 (confidence interval 0.15-0.57; P = 0.0005) and 0.35 (confidence interval 0.17-0.73; P = 0.008) in favor of the CA group. On average, CA was able to detect imminent mild and severe hypoxemia 83 and 99 s before standard monitoring. Standard monitoring represented an independent risk factor for hypoxemia and severe hypoxemia.
CONCLUSIONS


Respiratory complications of sedation during PEG placement are frequent events. CA is able to detect imminent hypoxemia at an early time point. This allows an early intervention and consecutively the avoidance of mild and severe hypoxemia. Therefore, CA monitoring can be recommended particularly during PEG insertion procedures.",2020,Odds ratios for hypoxemia and severe hypoxemia were 0.29 (CI 0.15-0.57; p=0.0005) and 0.35 (CI 0.17-0.73;,['150 patients'],"['percutaneous endoscopic gastrostomy (PEG) placement with propofol sedation comparing standard monitoring (SM) vs. SM with additional CA surveillance', 'SM or CA', 'CA', 'percutaneous endoscopic gastrostomy (PEG) placement']","['severe hypoxemia', 'Odds ratios for hypoxemia and severe hypoxemia', 'hypoxemia']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",150.0,0.0762758,Odds ratios for hypoxemia and severe hypoxemia were 0.29 (CI 0.15-0.57; p=0.0005) and 0.35 (CI 0.17-0.73;,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Peveling-Oberhag', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Michael', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tal', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Welsch', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Vermehren', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Farnik', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Grammatikos', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lange', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Walter', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Blumenstein', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Institute of Biostatistics and Mathematical Modelling, Goethe-University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Herrmann', 'Affiliation': 'Institute of Biostatistics and Mathematical Modelling, Goethe-University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Albert', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zeuzem', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Bojunga', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Mireen', 'Initials': 'M', 'LastName': 'Friedrich-Rust', 'Affiliation': 'Department of Internal Medicine I, University Hospital Frankfurt, Frankfurt am Main, Germany.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14760']
470,31493725,Timing-dependent interaction effects of tDCS with mirror therapy on upper extremity motor recovery in patients with chronic stroke: A randomized controlled pilot study.,"This study was a randomized, controlled pilot trial to investigate the timing-dependent interaction effects of dual transcranial direct current stimulation (tDCS) in mirror therapy (MT) for hemiplegic upper extremity in patients with chronic stroke. Thirty patients with chronic stroke were randomly assigned to three groups: tDCS applied before MT (prior-tDCS group), tDCS applied during MT (concurrent-tDCS group), and sham tDCS applied randomly prior to or concurrent with MT (sham-tDCS group). Dual tDCS at 1 mA was applied bilaterally over the ipsilesional M1 (anodal electrode) and the contralesional M1 (cathodal electrode) for 30 min. The intervention was delivered five days per week for two weeks. Upper extremity motor performance was measured using the Fugl-Meyer Assessment-Upper Extremity (FMA-UE), the Action Research Arm Test (ARAT), and the Box and Block Test (BBT). Assessments were administered at baseline, post-intervention, and two weeks follow-up. The results indicated that concurrent-tDCS group showed significant improvements in the ARAT in relation to the prior-tDCS group and sham-tDCS group at post-intervention. Besides, a trend toward greater improvement was also found in the FMA-UE for the concurrent-tDCS group. However, no statistically significant difference in the FMA-UE and BBT was identified among the three groups at either post-intervention or follow-up. The concurrent-tDCS seems to be more advantageous and time-efficient in the context of clinical trials combining with MT. The timing-dependent interaction factor of tDCS to facilitate motor recovery should be considered in future clinical application.",2019,"Besides, a trend toward greater improvement was also found in the FMA-UE for the concurrent-tDCS group.","['patients with chronic stroke', 'Thirty patients with chronic stroke']","['dual transcranial direct current stimulation (tDCS', 'mirror therapy (MT', 'tDCS with mirror therapy', 'tDCS applied before MT (prior-tDCS group), tDCS applied during MT (concurrent-tDCS group), and sham tDCS applied randomly prior to or concurrent with MT (sham-tDCS']","['Upper extremity motor performance', 'Fugl-Meyer Assessment-Upper Extremity (FMA-UE), the Action Research Arm Test (ARAT), and the Box and Block Test (BBT', 'ARAT', 'FMA-UE', 'FMA-UE and BBT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}]",30.0,0.025207,"Besides, a trend toward greater improvement was also found in the FMA-UE for the concurrent-tDCS group.","[{'ForeName': 'Minxia', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR; Shanghai Sunshine Rehabilitation Centre, Shanghai, China.'}, {'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR; Shanghai Sunshine Rehabilitation Centre, Shanghai, China.'}, {'ForeName': 'Zhongfei', 'Initials': 'Z', 'LastName': 'Bai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR; Shanghai Sunshine Rehabilitation Centre, Shanghai, China.'}, {'ForeName': 'Kenneth N K', 'Initials': 'KNK', 'LastName': 'Fong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR. Electronic address: rsnkfong@polyu.edu.hk.'}]",Journal of the neurological sciences,['10.1016/j.jns.2019.116436']
471,31505955,Influence of Infant Cleft Dimensions on Velopharyngeal Function in 5-Year-Old Danish Children Born With Unilateral Cleft Lip and Palate.,"AIM


To examine the association of cleft severity at infancy and velopharyngeal competence in preschool children with unilateral cleft lip and palate operated with early or delayed hard palate repair.
DESIGN


Subgroup analysis within a multicenter randomized controlled trial of primary surgery (Scandcleft).
SETTING


Tertiary health care. One surgical center.
PATIENTS AND METHODS


One hundred twenty-five infants received cheilo-rhinoplasty and soft palate repair at age 3 to 4 months and were randomized to hard palate closure at age 12 or 36 months. Cleft size and cleft morphology were measured 3 dimensionally on digital models, obtained by laser surface scanning of preoperative plaster models (mean age: 1.8 months).
MAIN OUTCOME MEASUREMENTS


Velopharyngeal competence (VPC) and hypernasality assessed from a naming test (VPC-Sum) and connected speech (VPC-Rate). In both scales, higher scores indicated a more severe velopharyngeal insufficiency.
RESULTS


No difference between surgical groups was shown. A low positive correlation was found between posterior cleft width and VPC-Rate (Spearman = .23;  P  = .025). The role of the covariate ""cleft size at tuberosity level"" was confirmed in an ordinal logistic regression model (odds ratio [OR] = 1.17; 95% confidence interval [CI]:1.01-1.35). A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = -.27;  P  = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99).
CONCLUSIONS


Posterior cleft dimensions can be a modest indicator for the prognosis of velopharyngeal function at age 5 years, when the soft palate is closed first, independently on the timing of hard palate repair. Antero-posterior palatal length seems to protect from velopharyngeal insufficiency and hypernasality. However, the association found was significant but low.",2020,"A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = -.27;  P  = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99).
","['5-Year-Old Danish Children Born With Unilateral Cleft Lip and Palate', 'preschool children with unilateral cleft lip and palate operated with early or delayed hard palate repair', 'One hundred twenty-five infants received', 'Tertiary health care']","['Infant Cleft Dimensions', 'primary surgery (Scandcleft', 'cheilo-rhinoplasty and soft palate repair at age 3 to 4 months and were randomized to hard palate closure']","['Velopharyngeal Function', 'posterior cleft width and VPC-Rate', 'severe velopharyngeal insufficiency', 'Cleft size and cleft morphology', 'Velopharyngeal competence (VPC) and hypernasality assessed from a naming test (VPC-Sum) and connected speech (VPC-Rate', 'anteroposterior palatal length and VPC-Sum']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C1536072', 'cui_str': 'Soft palate repair'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042454', 'cui_str': 'Velopharyngeal Incompetence'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0264614', 'cui_str': 'Hypernasality syndrome (disorder)'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",125.0,0.140521,"A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = -.27;  P  = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99).
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Botticelli', 'Affiliation': 'Section of Orthodontics, Aarhus University, Denmark.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Küseler', 'Affiliation': 'Section of Orthodontics, Aarhus University, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mølsted', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Helene Soegaard', 'Initials': 'HS', 'LastName': 'Andersen', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Shoeps', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Berit Kildegaard', 'Initials': 'BK', 'LastName': 'Emborg', 'Affiliation': 'Cleft Lip and Palate Center, IKH, Region Midt, Aarhus, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Kisling-Møller', 'Affiliation': 'Cleft Lip and Palate Center, IKH, Region Midt, Aarhus, Denmark.'}, {'ForeName': 'Thomas Klit', 'Initials': 'TK', 'LastName': 'Pedersen', 'Affiliation': 'Section of Orthodontics, Aarhus University, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Plastic Surgery and Burns Treatment, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Denmark.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619874143']
472,32161949,Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme.,"BACKGROUND AND AIMS


Oral systemic pan-Janus kinase [JAK] inhibition is effective for ulcerative colitis [UC] but is limited by toxicities. We describe preclinical to clinical translation of TD-1473-an oral gut-selective pan-JAK inhibitor-from in vitro characterization through a Phase 1b study in patients with UC.
METHODS


TD-1473 JAK inhibition potency was evaluated in vitro; plasma pharmacokinetics, safety and efficacy were assessed in mice. In a first-time-in-human study, plasma pharmacokinetics and safety were assessed after single and multiple [14 days] ascending doses administered orally to healthy subjects. The Phase 1b study randomized patients with moderately to severely active UC to receive once-daily oral TD-1473 20, 80 or 270 mg, or placebo for 28 days. Plasma and colonic tissue concentrations were measured; safety was assessed; and efficacy was evaluated by UC clinical parameters, disease-surrogate biomarkers, endoscopy, histology and colonic tissue JAK signalling.
RESULTS


TD-1473 exhibited potent pan-JAK inhibitory activity in vitro. Oral TD-1473 administration to mice achieved high, biologically active colonic tissue concentrations with low plasma exposure and decreased oxazolone-induced colitis activity without reducing blood cell counts vs placebo. TD-1473 administration in healthy human subjects and patients with UC yielded low plasma exposure and was generally well tolerated; treatment in patients with UC resulted in biologically active colonic tissue concentrations and descriptive trends toward reduced clinical, endoscopic and histological disease activity vs placebo.
CONCLUSION


Gut-selective pan-JAK inhibition with TD-1473 administration resulted in high intestinal vs plasma drug exposure, local target engagement, and trends toward reduced UC disease activity. [Clinicaltrials.gov NCT02657122, NCT02818686].",2020,"TD-1473 administration in healthy human subjects and patients with UC yielded low plasma exposure and was generally well tolerated; treatment in patients with UC resulted in biologically active colonic tissue concentrations and descriptive trends toward reduced clinical, endoscopic and histologic disease activity vs placebo.
","['healthy human subjects and patients with UC', 'patients with UC', 'ulcerative colitis']","['TD-1473', 'gut-selective pan-Janus kinase inhibitor', 'placebo', 'TD-1473-an oral gut-selective pan-JAK inhibitor']","['plasma pharmacokinetics and safety', 'biologically active colonic tissue concentrations', 'UC clinical parameters, disease-surrogate biomarkers, endoscopy, histology, and colonic tissue JAK signaling', 'vitro; plasma pharmacokinetics, safety, and efficacy', 'Plasma and colonic tissue concentrations']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]","[{'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C4521962', 'cui_str': 'Janus kinase inhibitor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3854325', 'cui_str': 'JAK Inhibitors'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}]",,0.069533,"TD-1473 administration in healthy human subjects and patients with UC yielded low plasma exposure and was generally well tolerated; treatment in patients with UC resulted in biologically active colonic tissue concentrations and descriptive trends toward reduced clinical, endoscopic and histologic disease activity vs placebo.
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Deanna D', 'Initials': 'DD', 'LastName': 'Nguyen', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Beattie', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Brassil', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Krey', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Situ', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Sana', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Sandvik', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'M Teresa', 'Initials': 'MT', 'LastName': 'Pulido-Rios', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Bhandari', 'Affiliation': 'Delta Research Partners, Monroe, LA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Leighton', 'Affiliation': 'Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Ganeshappa', 'Affiliation': 'Pinnacle Clinical Research, San Antonio, TX, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Boyle', 'Affiliation': 'Biomarker Laboratory, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Brihad', 'Initials': 'B', 'LastName': 'Abhyankar', 'Affiliation': 'Theravance Biopharma Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Kleinschek', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Graham', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panes', 'Affiliation': 'Department of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjaa049']
473,32164439,"Prevalence, Symptom Burden, and Underdiagnosis of Chronic Obstructive Pulmonary Disease in a Lung Cancer Screening Cohort.","Rationale:  Individuals eligible for lung cancer screening (LCS) by low-dose computed tomography (LDCT) are also at risk of chronic obstructive pulmonary disease (COPD) due to age and smoking exposure. Whether the LCS episode is useful for early detection of COPD is not well established. Objectives:  To explore associations between symptoms, comorbidities, spirometry, and emphysema in participants enrolled in the Lung Screen Uptake Trial. Methods:  This cross-sectional study was a prespecified analysis nested within Lung Screen Uptake Trial, which was a randomized study testing the impact of differing invitation materials on attendance of 60- to 75-year-old smokers and ex-smokers to a ""lung health check"" between November 2015 and July 2017. Participants with a smoking history ≥30 pack-years and who quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian model or ≥2.5% via the Liverpool Lung Project model, were offered LDCT. COPD was defined and classified according to the GOLD (Global Initiative for Obstructive Lung Disease) criteria using prebronchodilator spirometry. Analyses included the use of descriptive statistics, chi-square tests to examine group differences, and univariable and multivariable logistic regression to explore associations between symptom prevalence, airflow limitation, and visually graded emphysema. Results:  A total of 560 of 986 individuals included in the analysis (57%) had prebronchodilator spirometry consistent with COPD; 67% did not have a prior history of COPD and were termed ""undiagnosed."" Emphysema prevalence in those with known and ""undiagnosed"" COPD was 73% and 68%, respectively. A total of 32% of those with ""undiagnosed COPD"" had no emphysema on LDCT. Inhaler use and symptoms were more common in the ""known"" than the ""undiagnosed"" COPD group (63% vs. 33% with persistent cough [ P  < 0.001]; 73% vs. 33% with dyspnea [ P  < 0.001]). Comorbidities were common in all groups. Adjusted odds ratio (aOR) of respiratory symptoms were more significant for airflow obstruction (aOR GOLD 1 and 2, 1.57; confidence interval [CI], 1.14-2.17; aOR GOLD 3 and 4, 4.6; CI, 2.17-9.77) than emphysema (aOR mild, 1.12; CI, 0.81-1.55; aOR moderate, 1.33; CI, 0.85-2.09; aOR severe, 4.00; CI, 1.57-10.2). Conclusions:  There is high burden of ""undiagnosed COPD"" and emphysema in LCS participants. Adding spirometry findings to the LDCT enhances identification of individuals with COPD.Clinical trial registered with www.clinicaltrials.gov (NCT02558101).",2020,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","['560 of 986 individuals included in the analysis (57%) had pre-bronchodilator spirometry consistent with COPD', 'Individuals eligible for lung cancer screening (LCS) by low-dose', ""60-75 year-old smokers and ex-smokers to a 'lung health check' between November 2015 and July 2017"", 'individuals with COPD', 'participants enrolled in the Lung Screen Uptake Trial (LSUT', 'Participants with a smoking history ≥30 pack-years and quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian (PLCOm2012) model or ≥2.5% via the Liverpool Lung Project (LLP) model, were offered LDCT']","['LDCT', 'computed tomography (LDCT']","['Emphysema prevalence', 'Prevalence, Symptom Burden and Under-Diagnosis of Chronic Obstructive Pulmonary Disease', 'symptom prevalence, airflow limitation and visually graded emphysema', 'airflow obstruction']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",,0.146541,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","[{'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Horst', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Tisi', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hall', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Magali N', 'Initials': 'MN', 'LastName': 'Taylor', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Penny J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Burke', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'May-Jan', 'Initials': 'MJ', 'LastName': 'Soo', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Department of Radiology, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hurst', 'Affiliation': 'UCL Centre for Inflammation and Repair, University College London, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, United Kingdom; and.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201911-857OC']
474,31812550,The Impact of Distinct Exercise Training Modalities on Echocardiographic Measurements in Patients with Heart Failure with Reduced Ejection Fraction.,"BACKGROUND


Exercise training is an important component of multidisciplinary heart failure management. However, the effects of aerobic training (AT) versus resistance training (RT) on cardiac function in patients with heart failure with reduced ejection fraction are not well defined. The aim of this study was to evaluate the impact of these exercise modalities on echocardiographic parameters.
METHODS


Participants with stable heart failure with reduced ejection fraction (ejection fraction < 50%) were randomized to 12 weeks of AT, RT, or untrained control. Exercise was performed at matched relative intensities of each training modality (50%-70% of maximum). Echocardiography and cardiopulmonary exercise testing were performed at baseline and after 12 weeks of training.
RESULTS


Thirty-eight participants were randomized, and 12 in each group completed the intervention (mean age, 61.5 ± 1.7 years; 89% men). Peak oxygen consumption increased from 14.5 ± 1.3 to 17.2 ± 1.6 ml · min -1  · kg -1  after AT and from 13.7 ± 1.2 to 16.4 ± 1.1 ml · min -1  · kg -1  after RT (P < .001 for both). In the AT group, there was a decrease in septal e' (from 0.052 ± 0.004 to 0.041 ± 0.004 m/sec) and increases in E/e' ratio (from 18.2 ± 3.1 to 23.8 ± 3.5), left atrial volume (from 86 ± 9 to 99 ± 10 mL), and right ventricular end-diastolic area (from 18 ± 1 to 20 ± 1 cm 2 ; P < .05 for all), but these were unchanged in the control and RT groups. There were no significant changes in left ventricular diameters or volumes or right ventricular fractional area change after exercise.
CONCLUSIONS


There is a differential effect of AT versus RT on some echocardiographic parameters in patients with heart failure with reduced ejection fraction. AT was associated with evidence of worsening myocardial diastolic function, whereas this was not apparent after RT. Further studies are indicated to investigate the long-term clinical significance of these adaptations.",2020,There is a differential effect of AT versus RT on some echocardiographic parameters in patients with heart failure with reduced ejection fraction.,"['Patients with Heart Failure with Reduced Ejection Fraction', 'patients with heart failure with reduced ejection fraction', 'Participants with stable heart failure with reduced ejection fraction (ejection fraction\xa0<\xa050', 'Thirty-eight participants were randomized, and 12 in each group completed the intervention (mean\xa0age, 61.5\xa0±\xa01.7\xa0years; 89% men']","['Distinct Exercise Training Modalities', 'Echocardiography and cardiopulmonary exercise testing', 'aerobic training (AT) versus resistance training (RT', 'Exercise training']","['Peak oxygen consumption', 'right ventricular end-diastolic area', ""E/e' ratio"", 'left ventricular diameters or volumes or right ventricular fractional area change', 'left atrial volume', 'Echocardiographic Measurements', 'worsening myocardial diastolic function', 'septal e', 'cardiac function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",38.0,0.0366833,There is a differential effect of AT versus RT on some echocardiographic parameters in patients with heart failure with reduced ejection fraction.,"[{'ForeName': 'Nick S R', 'Initials': 'NSR', 'LastName': 'Lan', 'Affiliation': 'Department of Cardiology, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Lam', 'Affiliation': 'Department of Cardiology, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'Allied Health Department, Fiona Stanley Hospital, Murdoch, Australia; School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'Allied Health Department, Fiona Stanley Hospital, Murdoch, Australia; School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Novia S', 'Initials': 'NS', 'LastName': 'Minaee', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dias', 'Affiliation': 'Department of Cardiology, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Maiorana', 'Affiliation': 'Allied Health Department, Fiona Stanley Hospital, Murdoch, Australia; School of Physiotherapy and Exercise Science, Curtin University, Bentley, Australia. Electronic address: a.maiorana@curtin.edu.au.'}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2019.09.012']
475,29878183,Population Priorities for Successful Aging: A Randomized Vignette Experiment.,"OBJECTIVES


Aging populations have led to increasing interest in ""successful aging"" but there is no consensus as to what this entails. We aimed to understand the relative importance to the general population of six commonly-used successful aging dimensions (disease, disability, physical functioning, cognitive functioning, interpersonal engagement, and productive engagement).
METHOD


Two thousand and ten British men and women were shown vignettes describing an older person with randomly determined favorable/unfavorable outcomes for each dimension and asked to score (0-10) how successfully the person was aging.
RESULTS


Vignettes with favorable successful aging dimensions were given higher mean scores than those with unfavorable dimensions. The dimensions given greatest importance were cognitive function (difference [95% confidence interval {CI}] in mean scores: 1.20 [1.11, 1.30]) and disability (1.18 [1.08, 1.27]), while disease (0.73 [0.64, 0.82]) and productive engagement (0.58 [0.49, 0.66]) were given the least importance. Older respondents gave increasingly greater relative importance to physical function, cognitive function, and productive engagement.
DISCUSSION


Successful aging definitions that focus on disease do not reflect the views of the population in general and older people in particular. Practitioners and policy makers should be aware of older people's priorities for aging and understand how these differ from their own.",2020,"The dimensions given greatest importance were cognitive function (difference [95% confidence interval {CI}] in mean scores: 1.20 [1.11, 1.30]) and disability (1.18 [1.08, 1.27]), while disease (0.73 [0.64, 0.82]) and productive engagement (0.58 [0.49, 0.66]) were given the least importance.","['Population Priorities for Successful Aging', 'Older respondents']",[],"['cognitive function', 'productive engagement', 'successful aging dimensions (disease, disability, physical functioning, cognitive functioning, interpersonal engagement, and productive engagement', 'disability']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549179', 'cui_str': 'Priority (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]",[],"[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",2010.0,0.0508829,"The dimensions given greatest importance were cognitive function (difference [95% confidence interval {CI}] in mean scores: 1.20 [1.11, 1.30]) and disability (1.18 [1.08, 1.27]), while disease (0.73 [0.64, 0.82]) and productive engagement (0.58 [0.49, 0.66]) were given the least importance.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Whitley', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Benzeval', 'Affiliation': 'Institute for Social and Economic Research, University of Essex, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Popham', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, UK.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby060']
476,32150048,The influence of educational measures and low-level laser phototherapy on temporomandibular disorders: Study protocol clinical trial (SPIRIT Compliant).,"Photobiomodulation therapy (PBMT) with low-power laser is used for pain relief in several clinical conditions, including temporomandibular disorders (TMD). As musculoskeletal pain often produces changes in motor behavior, it is common for patients with TMD to present limited mandibular movements. To the date, there is no consensus about the optimal dosimetric parameters of PMBT for TMD. This randomized, controlled, double-blind clinical trial aims to evaluate pain relief and mandibular mobility in patients with TMD following treatments with 2 laser wavelengths, red (660 nm) and infrared (808 nm) individually and in combination as compared to a placebo treatment. One-hundred participants presenting myalgia and arthralgia, with disk displacement or not, will be selected based on the Research Diagnostic Criteria for Temporomandibular Disorders. All participants will be instructed about the etiology, prognosis, and self-care techniques for pain control on TMD, and followed up for 2 weeks. After this period, those who still present pain score over 4 in a visual analog scale (VAS) will be included in the study. Participants will be randomly assigned to 4 treatment groups: G1 = placebo (SHAM); G2 = PBMT with red laser (660 nm, 0.034 cm, 88 J/cm, 100 mW, 3 J/point); G3 = PBMT with infrared laser (808 nm, 0.034 cm, 88 J/cm, 100 mW, 3 J/point); and G4 = PBMT with red and infrared laser alternated between sessions. The treatment consists of 8 sessions, 2 times a week. The effect of the proposed therapies will be measured by: pain reduction in VAS; pressure pain threshold on TMJ, masseter and temporal muscles; and the amplitude of mandibular movements (opening, protrusion, and right and left lateral movements). The data will be collected at the following times: initial (T1), after the 1st treatment session (T2), at the end of treatment (T3), and 30 days after the last PBMT session (T4). For statistical analysis will be used 2-way repeated measures analysis of variance test, complemented by a post hoc Tukey test (P < .05).",2020,"Photobiomodulation therapy (PBMT) with low-power laser is used for pain relief in several clinical conditions, including temporomandibular disorders (TMD).","['patients with TMD following treatments with 2 laser wavelengths, red (660\u200anm) and infrared (808\u200anm) individually and in combination as compared to a', 'One-hundred participants presenting myalgia and arthralgia, with disk displacement or not, will be selected based on the Research Diagnostic Criteria for Temporomandibular Disorders', 'temporomandibular disorders', 'patients with TMD']","['placebo treatment', 'G1 = placebo (SHAM); G2 = PBMT with red laser', 'educational measures and low-level laser phototherapy', 'Photobiomodulation therapy (PBMT) with low-power laser', 'G4 = PBMT with red and infrared laser alternated between sessions', 'PBMT with infrared laser']","['amplitude of mandibular movements (opening, protrusion, and right and left lateral movements', 'visual analog scale (VAS', 'pain score', 'pain relief and mandibular mobility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0449819', 'cui_str': 'Wavelength (qualifier value)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C1532326', 'cui_str': 'Infrared'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035168'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1289899', 'cui_str': 'Red laser'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",100.0,0.223961,"Photobiomodulation therapy (PBMT) with low-power laser is used for pain relief in several clinical conditions, including temporomandibular disorders (TMD).","[{'ForeName': 'Caroline Maria Gomes', 'Initials': 'CMG', 'LastName': 'Dantas', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry.'}, {'ForeName': 'Carolina Lapaz', 'Initials': 'CL', 'LastName': 'Vivan', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry.'}, {'ForeName': 'Solange Mongelli', 'Initials': 'SM', 'LastName': 'de Fantini', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry.'}, {'ForeName': 'Patrícia Moreira', 'Initials': 'PM', 'LastName': 'de Freitas Costa E Silva', 'Affiliation': 'Department of Restorative Dentistry, Co-Chairman of the Special Laboratory of Lasers in Dentistry.'}, {'ForeName': 'Claudio Mendes', 'Initials': 'CM', 'LastName': 'Pannuti', 'Affiliation': 'Department of Stomatology, School of Dentistry - University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Andrea Lusvarghi', 'Initials': 'AL', 'LastName': 'Witzel', 'Affiliation': 'Department of Stomatology, School of Dentistry - University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Gladys Cristina', 'Initials': 'GC', 'LastName': 'Dominguez', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry.'}]",Medicine,['10.1097/MD.0000000000019005']
477,32151460,"Erratum to 'Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial' [European Journal of Cancer, Volume 124 (January 2020) Pages 91-101].",,2020,,['advanced pancreatic cancer'],['Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.0238767,,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Digestive and Medical Oncology Unit, Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris, University Denis Diderot Paris VII, 92110 Clichy, France. Electronic address: pascal.hammel@aphp.fr.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Parc Euromedecine, 208 Rue Des Apothicaires, 34070 Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Institut Sainte Catherine, Gastrointestinal and Liver Cancer Unit, Chemin de Baigne Pieds, 84000 Avignon, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': 'CHRU de Brest - Hôpital Morvan, 2 Avenue Foch, 29609 Brest, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75012 Paris, and Sorbonne Universités, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'De La Fouchardiere', 'Affiliation': 'Medical Oncology Department, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Medical Oncology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014 Paris, France.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'El Hajbi', 'Affiliation': 'Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Les Oudairies, Hospital La Roche-Sur-Yon, Boulevard Stephane Moreau, 85000 La Roche Sur Yon, France.'}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Guimbaud', 'Affiliation': 'Institut Universitaire du Cancer, Avenue Hubert Curien, 31100 Toulouse, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Faculty of Medicine of Poitiers, 86000 Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': 'Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepatogastroenterology and Digestive Oncology, CHU de Tours, 37044 Tours Cedex, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rebischung', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble, 8 Rue Docteur Calmette, 38100 Grenoble, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': ""Service d'Oncologie médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Est, 94010 Créteil, France.""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon University Hospital, Department of Pathology-INSERM U1149, 100 Bvd Gal Lerclerc, 92110 Clichy, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kay', 'Affiliation': 'RK Statistics Ltd, St Giles View, Main Street, Great Longstone, Bakewell DE45 1TZ, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hamm', 'Affiliation': 'Cytel Inc., 675 Massachusetts Ave, Cambridge, MA 02139, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Universités, UPMC Université, Gastroenterology and Digestive Oncology Department, Pitié Salpêtrière Hospital, 75013 Paris, France; Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'El Hariry', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA; Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.004']
478,31973041,Experience of Stress Assessed by Text Messages and Its Association with Objective Workload-A Longitudinal Study.,"Exploring stress trajectories in detail and over a long time may give valuable information in terms of both understanding and practice. We followed a group of primary health care employees in a randomized controlled trial. The objective was to describe their experience of stress, explore the intra-individual variability and examine the association between the experience of stress and the objective workload. Weekly text messages with a single item stress question were distributed in two time series: 12 weeks at the beginning of the trial and 26 weeks after the 6-month follow up. Aggregated objective data about workload were collected from their administration office and related to stress levels. There was a seasonal variation, with higher stress during the fall than in spring and summer. The analysis comparing high and low stress subgroups showed that the stress trajectory of a high-stress subgroup was different from that of a low-stress subgroup. Individuals with high exhaustion scores had higher odds of belonging to a subgroup of individuals with high intra-individual variability in stress experience. The objective workload was measured in two ways and was strongly associated with the stress experience. We found that the lower the productivity, the higher the feeling of stress.",2020,Individuals with high exhaustion scores had higher odds of belonging to a subgroup of individuals with high intra-individual variability in stress experience.,[],[],['objective workload'],[],[],"[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]",,0.0217825,Individuals with high exhaustion scores had higher odds of belonging to a subgroup of individuals with high intra-individual variability in stress experience.,"[{'ForeName': 'Bozana', 'Initials': 'B', 'LastName': 'Arapovic-Johansson', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institute, 171 77 Solna, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Wåhlin', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institute, 171 77 Solna, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hagberg', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institute, 171 77 Solna, Sweden.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Kwak', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institute, 171 77 Solna, Sweden.'}, {'ForeName': 'Iben', 'Initials': 'I', 'LastName': 'Axén', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institute, 171 77 Solna, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Björklund', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institute, 171 77 Solna, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institute, 171 77 Solna, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17030680']
479,32151528,Monitoring ocular discomfort using a wrist-mounted electronic logger.,"PURPOSE


To investigate ocular discomfort during contact lens wear using a wrist-mounted electronic 'lens awareness logger' (LAL).
METHODS


Thirty symptomatic contact lens wearers wore study contact lenses for three days. On the first two days, two lens types which are known to differ in end-of-day comfort (lens A: senofilcon A and lens B: balafilcon A), were worn as a matching pair (randomised order). On day three, a pair of lens B was worn. On each day, the participant used a LAL. On day one and two, the participant pressed a button on the LAL whenever they became aware of their lenses due to discomfort. On day three, the participant used a multiple click protocol (1 = mild awareness to 3 = severe awareness) to report discomfort.
RESULTS


LAL events were similar on days one and two (17.3 vs. 15.8 events per day). There were significantly more LAL events for lens B (21.6 events per day) in comparison with lens A (11.6 events per day) (p = 0.006). The LAL event profile highlighted peaks in awareness following lens application and towards the end of the wearing cycle. Comparison of the LAL event profile for the two lens types showed significant differences in lens awareness, particularly in the first half of the wearing cycle. LAL events on day 3, showed a uniform distribution of single and double clicks through the day, but a marked peak in triple clicks in the last two hours of lens wear.
CONCLUSION


The LAL was able to differentiate between the study lenses and demonstrated differences in their LAL event profiles. Lens awareness associated with discomfort appeared to increase not only in frequency, but also in intensity towards the end of the wearing cycle. The ability of the LAL to track lens awareness suggests it is likely to be a useful tool in furthering understanding of ocular discomfort.",2020,There were significantly more LAL events for lens B (21.6 events per day) in comparison with lens A (11.6 events per day) (p = 0.006).,['Thirty symptomatic contact lens wearers'],[],"['LAL events', 'lens awareness']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}]",[],"[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",30.0,0.0263298,There were significantly more LAL events for lens B (21.6 events per day) in comparison with lens A (11.6 events per day) (p = 0.006).,"[{'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Read', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK. Electronic address: michael.read-3@manchester.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Navascues-Cornago', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Keir', 'Affiliation': 'CooperVision Inc., 6150 Stoneridge Mall Rd, Pleasanton, California 94588, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Maldonado-Codina', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK.'}, {'ForeName': 'Philip B', 'Initials': 'PB', 'LastName': 'Morgan', 'Affiliation': 'Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, UK.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.02.010']
480,32160504,Ultrasound-guided versus blind subacromial corticosteroid and local anesthetic injection in the treatment of subacromial impingement syndrome: A randomized study of efficacy.,"OBJECTIVES


This study aims to compare the effects of ultrasound (US)-guided and blind subacromial corticosteroid and local anesthetic (LA) injection in the treatment of subacromial impingement syndrome (SIS) on shoulder pain, range of motion (ROM), and functionality.
PATIENTS AND METHODS


The prospective study was conducted between 01 February 2017 and 31 May 2017. A total of 29 patients with clinical findings and magnetic resonance imaging (MRI) consistent with SIS were randomized into two groups: 14 patients received US-guided subacromial corticosteroid and LA injection and 15 patients received a blind subacromial corticosteroid and LA injection. Patients were evaluated before and one month after treatment. One patient was lost to follow up. The primary outcome measure was a visual analog scale (VAS) for shoulder pain. Secondary outcomes were active shoulder ROM in flexion and abduction, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the modified Constant-Murley Score (CMS).
RESULTS


Twenty-eight patients (11 males, 17 females; mean age 39.5 in the US guided group and 42.5 in the blind group; range 20 to 64 years in both groups) completed the study. There was a significant improvement in VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS in both groups four weeks after treatment (p<0.05). There was no between-group difference in VAS, ROM or DASH questionnaire scores. Following treatment, the modified CMS in the US-guided injection group was higher than in the blind injection group (p=0.02). However, when the mean change in modified CMS in the US-guided injection group was compared to that of the blind injection group, the difference was insignificant (p=0.23).
CONCLUSION


Both US-guided and blind subacromial steroid injection improve shoulder pain, ROM, and functionality in SIS; one treatment option was not found to be superior to the other. Therefore, blind injection can be performed in clinical settings where US is not available. Equally, blind injection can also be performed in patients who have a definite diagnosis of SIS based on clinical and MRI findings.",2020,"There was a significant improvement in VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS in both groups four weeks after treatment (p<0.05).","['subacromial impingement syndrome', 'Twenty-eight patients (11 males, 17 females; mean age 39.5 in the US guided group and 42.5 in the blind group; range 20 to 64 years in both groups) completed the study', 'patients who have a definite diagnosis of SIS based on clinical and MRI findings', '29 patients with clinical findings and magnetic resonance imaging (MRI) consistent with SIS were randomized into two groups: 14 patients received', '01 February 2017 and 31 May 2017', 'subacromial impingement syndrome (SIS']","['subacromial steroid injection', 'ultrasound (US)-guided and blind subacromial corticosteroid and local anesthetic (LA) injection', 'Ultrasound-guided versus blind subacromial corticosteroid and local anesthetic injection', 'US-guided subacromial corticosteroid and LA injection and 15 patients received a blind subacromial corticosteroid and LA injection']","['shoulder pain, ROM, and functionality in SIS', 'VAS, ROM or DASH questionnaire scores', 'VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS', 'visual analog scale (VAS) for shoulder pain', 'mean change in modified CMS', 'shoulder pain, range of motion (ROM), and functionality', 'active shoulder ROM in flexion and abduction, the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the modified Constant-Murley Score (CMS']","[{'cui': 'C4255192', 'cui_str': 'Coracohumeral Impingement'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}]","[{'cui': 'C4302319', 'cui_str': 'Injection of steroid into subacromial region of shoulder'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",29.0,0.0519222,"There was a significant improvement in VAS for shoulder pain, active ROM, DASH questionnaire score and modified CMS in both groups four weeks after treatment (p<0.05).","[{'ForeName': 'Najibeh', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Başkent University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Ozen', 'Affiliation': ''}, {'ForeName': 'Huma Bölük', 'Initials': 'HB', 'LastName': 'Şenlikçi', 'Affiliation': ''}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Haberal', 'Affiliation': ''}, {'ForeName': 'Nuri', 'Initials': 'N', 'LastName': 'Çetin', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.71056']
481,32155622,Preoperative Oral Carbohydrate Reduces Postoperative Insulin Resistance by Activating AMP-Activated Protein Kinase after Colorectal Surgery.,"BACKGROUND


Postoperative insulin resistance (PIR) is a common response after colorectal surgery and an independent risk factor for recovery. Preoperative oral carbohydrate (POC) has been known to reduce PIR. Herein, we investigated whether its mechanism of action involves AMP-activated protein kinase (AMPK) and mTOR/S6K1/insulin receptor substrate-1 (IRS-1) pathways.
METHODS


Patients undergoing colorectal cancer resection were randomly assigned to a POC, fasting, or placebo group. The exclusion criteria were association with diseases or intake of medication affecting insulin sensitivity. Pre- and postoperative insulin resistance, and protein phosphorylation of AMPK, mTOR, and IRS-1 in the rectus abdominis muscle were evaluated.
RESULTS


From January 2017 to December 2017, 70 patients were randomized and 63 were evaluated. No difference was found in the clinical and operative characteristics among the 3 groups. In the POC group, the levels of blood glucose, blood insulin, and homeostasis model assessment of insulin resistance were significantly lower in the POC group than the fasting and placebo groups, and the insulin sensitivity index was significantly higher. The phosphorylation of AMPK in the POC group was significantly higher than that in the other 2 groups, whereas the phosphorylation of mTOR and IRS-1 was significantly lower.
CONCLUSION


PIR involves AMPK and mTOR/S6K1/IRS-1 pathways. POC reduces PIR by the stimulation of AMPK, which suppresses the phosphorylation of mTOR/IRS-1 and attenuates PIR after colorectal resection.",2020,"In the POC group, the levels of blood glucose, blood insulin, and homeostasis model assessment of insulin resistance were significantly lower in the POC group than the fasting and placebo groups, and the insulin sensitivity index was significantly higher.","['From January 2017 to December 2017, 70 patients were randomized and 63 were evaluated', 'Patients undergoing colorectal cancer resection']","['Preoperative oral carbohydrate (POC', 'POC, fasting, or placebo']","['phosphorylation of mTOR and IRS-1', 'Pre- and postoperative insulin resistance, and protein phosphorylation of AMPK, mTOR, and IRS-1 in the rectus abdominis muscle', 'levels of blood glucose, blood insulin, and homeostasis model assessment of insulin resistance', 'phosphorylation of AMPK', 'insulin sensitivity index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",70.0,0.0374651,"In the POC group, the levels of blood glucose, blood insulin, and homeostasis model assessment of insulin resistance were significantly lower in the POC group than the fasting and placebo groups, and the insulin sensitivity index was significantly higher.","[{'ForeName': 'Mengyao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Gastro-intestine Surgery, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zunqi', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Gastro-intestine Surgery, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Dejun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Gastro-intestine Surgery, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Qingping', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': 'Department of Gastro-intestine Surgery, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhenxin', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastro-intestine Surgery, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China, zhuzhenxin@smmu.edu.cn.'}]",Digestive surgery,['10.1159/000505515']
482,31097078,Manualised cognitive-behavioural therapy in treating depression in advanced cancer: the CanTalk RCT.,"BACKGROUND


With a prevalence of up to 16.5%, depression is one of the commonest mental disorders in people with advanced cancer. Depression reduces the quality of life (QoL) of patients and those close to them. The National Institute for Health and Care Excellence (NICE) guidelines recommend treating depression using antidepressants and/or psychological treatments, such as cognitive-behavioural therapy (CBT). Although CBT has been shown to be effective for people with cancer, it is unclear whether or not this is the case for people with advanced cancer and depression.
OBJECTIVES


To assess the clinical effectiveness and cost-effectiveness of treatment as usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU for people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks.
DESIGN


Parallel-group, single-blind, randomised trial, stratified by whether or not an antidepressant was prescribed, comparing TAU with CBT plus TAU.
SETTING


Recruitment took place in oncology, hospice and primary care settings. CBT was delivered in IAPT centres or/and over the telephone.
PARTICIPANTS


Patients ( N  = 230;  n  = 115 in each arm) with advanced cancer and depression. Inclusion criteria were a diagnosis of cancer not amenable to cure, a DSM-IV ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition) diagnosis of depressive disorder using the Mini-International Neuropsychiatric Interview, a sufficient understanding of English and eligibility for treatment in an IAPT centre. Exclusion criteria were an estimated survival of < 4 months, being at high risk of suicide and receiving, or having received in the last 2 months, a psychological intervention recommended by NICE for treating depression.
INTERVENTIONS


(1) Up to 12 sessions of manualised individual CBT plus TAU delivered within 16 weeks and (2) TAU.
OUTCOME MEASURES


The primary outcome was the Beck Depression Inventory, version 2 (BDI-II) score at 6, 12, 18 and 24 weeks. Secondary outcomes included scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory, at 12 and 24 weeks.
RESULTS


A total of 80% of treatments (185/230) were analysed: CBT (plus TAU) ( n  = 93) and TAU ( n  = 92) for the BDI-II score at all time points using multilevel modelling. CBT was not clinically effective [treatment effect -0.84, 95% confidence interval (CI) -2.76 to 1.08;  p  = 0.39], nor was there any benefit for other measures. A subgroup analysis of those widowed, divorced or separated showed a significant effect of CBT on the BDI-II (treatment effect -7.21, 95% CI -11.15 to -3.28;  p  < 0.001). Economic analysis revealed that CBT has higher costs but produces more quality-adjusted life-years (QALYs) than TAU. The mean service costs for participants (not including the costs of the interventions) were similar across the two groups. There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks. There was no statistically significant improvement in QALYs at 24 weeks.
LIMITATIONS


Although all participants satisfied a diagnosis of depression, for some, this was of less than moderate severity at baseline, which could have attenuated treatment effects. Only 64% (74/115) took up CBT, comparable to the general uptake through IAPT.
CONCLUSIONS


Cognitive-behavioural therapy (delivered through IAPT) does not achieve any clinical benefit in advanced cancer patients with depression. The benefit of CBT for people widowed, divorced or separated is consistent with other studies. Alternative treatment options for people with advanced cancer warrant evaluation. Screening and referring those widowed, divorced or separated to IAPT for CBT may be beneficial. Whether or not improvements in this subgroup are due to non-specific therapeutic effects needs investigation.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN07622709.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 19. See the NIHR Journals Library website for further project information.",2019,"There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks.","['advanced cancer patients with depression', 'people with cancer', 'Recruitment took place in oncology, hospice and primary care settings', 'people with advanced cancer and depression', '115 in each arm) with advanced cancer and depression', 'people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks', 'advanced cancer', 'people with advanced cancer', 'people with advanced cancer warrant evaluation', 'Patients ( N \u2009=\u2009230;  n \u2009']","['psychological intervention recommended by NICE', 'CBT', 'usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU', 'manualised individual CBT plus TAU', 'CBT (plus TAU', 'Cognitive-behavioural therapy (delivered through IAPT', 'Manualised cognitive-behavioural therapy']","['scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory', 'mean service costs', 'EQ-5D median scores', 'clinical effectiveness and cost-effectiveness', 'Beck Depression Inventory, version 2 (BDI-II) score', 'quality of life (QoL']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0303407', 'cui_str': 'In-115 radioisotope'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034380'}]",,0.229638,"There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Serfaty', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Nazareth', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Stirling', 'Initials': 'S', 'LastName': 'Moorey', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Trefor', 'Initials': 'T', 'LastName': 'Aspden', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Tookman', 'Affiliation': 'Marie Curie Hospice, Royal Free Hampstead NHS Trust, London, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mannix', 'Affiliation': 'Palliative Care Service, Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gola', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Research Department of Primary Care & Population Health, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23190']
483,31698177,Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study.,"The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52-week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with open-label eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (-2.4 [1.34] and - 3.3 [0.65]); Quantitative Myasthenia Gravis (-2.9 [1.98] and - 4.3 [0.79]); Myasthenia Gravis Composite (-4.5 [2.63] and - 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (-8.6 [5.68] and - 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population.",2019,"The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229).","['Japanese patients with generalized myasthenia gravis', 'Japanese and Caucasian patients', '11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis']","['placebo', 'eculizumab']","['Myasthenia Gravis Quality of Life 15-item questionnaire', 'Myasthenia Gravis Composite', 'Myasthenia Gravis Activities of Daily Living', 'efficacy and safety', 'myasthenia gravis-related symptoms', 'Quantitative Myasthenia Gravis']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}]","[{'cui': 'C0947912'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}]",11.0,0.271281,"The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Murai', 'Affiliation': 'Department of Neurology, International University of Health and Welfare, Tokyo, Japan. Electronic address: murai@iuhw.ac.jp.'}, {'ForeName': 'Akiyuki', 'Initials': 'A', 'LastName': 'Uzawa', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan. Electronic address: auzawa@chiba-u.jp.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, National Hospital Organization Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Tomihiro', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Neurology, Sapporo Medical University Hospital, Sapporo, Japan. Electronic address: toimai@sapmed.ac.jp.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Neurology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Neurology, Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Meinoshin', 'Initials': 'M', 'LastName': 'Okumura', 'Affiliation': 'Osaka Toneyama Medical Center, Toyonaka, Japan. Electronic address: meinosin@toneyama.go.jp.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': ""O'Brien"", 'Affiliation': 'Alexion Pharmaceuticals, Boston, MA, United States. Electronic address: fanny.obrien@alexion.com.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Formerly of Alexion Pharmaceuticals, Boston, MA, United States.'}, {'ForeName': 'Kenji P', 'Initials': 'KP', 'LastName': 'Fujita', 'Affiliation': 'Formerly of Alexion Pharmaceuticals, Boston, MA, United States.'}, {'ForeName': 'Kimiaki', 'Initials': 'K', 'LastName': 'Utsugisawa', 'Affiliation': 'Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan. Electronic address: kutsugi@s4.dion.ne.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the neurological sciences,['10.1016/j.jns.2019.08.004']
484,29470854,The Cost-Effectiveness of Screening in the Community to Reduce Osteoporotic Fractures in Older Women in the UK: Economic Evaluation of the SCOOP Study.,"The SCOOP study was a two-arm randomized controlled trial conducted in the UK in 12,483 eligible women aged 70 to 85 years. It compared a screening program using the FRAX® risk assessment tool in addition to bone mineral density (BMD) measures versus usual management. The SCOOP study found a reduction in the incidence of hip fractures in the screening arm, but there was no evidence of a reduction in the incidence of all osteoporosis-related fractures. To make decisions about whether to implement any screening program, we should also consider whether the program is likely to be a good use of health care resources, ie, is it cost-effective? The cost per gained quality adjusted life year of screening for fracture risk has not previously been demonstrated in an economic evaluation alongside a clinical trial. We conducted a ""within trial"" economic analysis alongside the SCOOP study from the perspective of a national health payer, the UK National Health Service (NHS). The main outcome measure in the economic analysis was the cost per quality adjusted life year (QALY) gained over a 5-year time period. We also estimated cost per osteoporosis-related fracture prevented and the cost per hip fracture prevented. The screening arm had an average incremental QALY gain of 0.0237 (95% confidence interval -0.0034 to 0.0508) for the 5-year follow-up. The incremental cost per QALY gained was £2772 compared with the control arm. Cost-effectiveness acceptability curves indicated a 93% probability of the intervention being cost-effective at values of a QALY greater than £20,000. The intervention arm prevented fractures at a cost of £4478 and £7694 per fracture for osteoporosis-related and hip fractures, respectively. The current study demonstrates that a systematic, community-based screening program of fracture risk in older women in the UK represents a highly cost-effective intervention. © 2018 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.",2018,"Cost-effectiveness acceptability curves indicated a 93% probability of the intervention being cost-effective at values of a QALY greater than £20,000.","['older women in the UK', 'Older Women in the UK', '12,483 eligible women aged 70 to 85 years']",['community-based screening program'],"['cost per quality adjusted life year (QALY) gained over a 5-year time period', 'Osteoporotic Fractures', 'average incremental QALY gain', 'bone mineral density (BMD) measures', 'incidence of hip fractures', 'Cost-Effectiveness', 'Cost-effectiveness acceptability curves', 'incremental cost per QALY gained']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",12483.0,0.0386078,"Cost-effectiveness acceptability curves indicated a 93% probability of the intervention being cost-effective at values of a QALY greater than £20,000.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Turner', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Rebekah Fong Soe', 'Initials': 'RFS', 'LastName': 'Khioe', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lenaghan', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Gittoes', 'Affiliation': 'Centre for Endocrinology, Diabetes, and Metabolism, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, Centre for Medicine, University of Leicester, Leicester, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'McCloskey', 'Affiliation': 'Mellanby Centre for Bone Research, Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Terence W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'National Institute of Health Research Manchester Musculoskeletal BRU, Central Manchester University Hospitals NHS Foundation Trust & Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fordham', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3381']
485,31222778,"The holistic assessment and care planning in partnership intervention study (HAPPI): A protocol for a feasibility, cluster randomized controlled trial.","AIM


During an initial phase of this research, an e-Delphi survey was conducted to gain consensus among stakeholders on the components of a nurse-led assessment and care planning intervention for older people who live with frailty in primary care. This feasibility randomized controlled trial (fRCT) will test the proposed intervention and its implementation and determine methods for the design of a conclusive randomized controlled trial.
METHODS


The fRCT, with embedded qualitative study, aims to recruit 60 participants. Moderately and severely frail older people will be identified using the electronic frailty index (eFI) and the intervention will be delivered by senior community nurses. The control participants will receive usual primary care for frailty. The study is funded by the National Institute of Health Research (NIHR; funding granted in May 2016, ref: ICA-CDRF-2016-02-018) and received NHS and University Research Ethics Committee approval in 2018.
DISCUSSION


There is evidence that the delivery of complex interventions for community-dwelling older people can reduce care home and hospital admissions and falls, there is less evidence for the benefit of any specific type or intensity of intervention or the additional benefits of targeting the frail population. This trial will determine feasibility of the intervention, define recruitment and retention parameters and trial logistics, and decide outcome measures.
IMPACT


This study aims to address the limitations of current research by using a systematic method of frailty diagnosis and participant identification, trialling implementation of a person-centred intervention, and testing of feasibility parameters.
TRIAL REGISTRATION NUMBER


ISRCTN: 74345449.",2019,"There is evidence that the delivery of complex interventions for community-dwelling older people can reduce care home and hospital admissions and falls, there is less evidence for the benefit of any specific type or intensity of intervention or the additional benefits of targeting the frail population.","['older people who live with frailty in primary care', '60 participants', 'Moderately and severely frail older people', 'community-dwelling older people']","['HAPPI', 'complex interventions', 'nurse-led assessment and care planning intervention']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]",[],,0.205898,"There is evidence that the delivery of complex interventions for community-dwelling older people can reduce care home and hospital admissions and falls, there is less evidence for the benefit of any specific type or intensity of intervention or the additional benefits of targeting the frail population.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lyndon', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jos M', 'Initials': 'JM', 'LastName': 'Latour', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Stevens', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'Kent', 'Affiliation': 'Faculty of Health and Human Sciences, University of Plymouth, Plymouth, UK.'}]",Journal of advanced nursing,['10.1111/jan.14106']
486,32162213,Health Demands Moderate the Link Between Willpower Beliefs and Physical Activity in Patients with Knee Osteoarthritis.,"BACKGROUND


Regular physical activity (PA) was found to alleviate pain and improve functioning among patients with osteoarthritis of the knee (OAK). Heightened health demands due to OAK severity, body mass index (BMI), and depressive symptoms may require self-regulatory strategies to engage in more PA. Research on willpower-the capacity to exert self-control-suggests that believing that willpower is a nonlimited rather than a limited resource predicts effective self-regulation specifically when demands are high. The present study examines the association of OAK patients' willpower beliefs with their daily PA as a function of health demands.
METHODS


To identify the moderating role of OAK severity (WOMAC), BMI, and depressive symptoms (CES-D) on the link between willpower beliefs and objectively assessed PA over a 7-day period, baseline data of a registered randomized controlled trial with 243 patients (M age  = 65.47 years, SD = 0.49) were examined in secondary analyses.
RESULTS


Moderation analyses revealed that overall positive associations of willpower beliefs with PA were further qualified by OAK severity, BMI, and depressive symptoms. When patients faced less health demands, believing that willpower is nonlimited was associated with more PA. When health demands were higher, willpower beliefs were not associated with PA.
CONCLUSION


OAK patients' willpower beliefs were associated with PA. However, facing more health demands seemed to erase this beneficial link. Improving willpower beliefs by way of intervention may help to shed more light on predictive direction and ways to overcome barriers to regular physical activity.",2020,"When health demands were higher, willpower beliefs were not associated with PA.
","['243 patients (M age \u2009=\u200965.47\xa0years, SD\u2009=\u20090.49', 'patients with osteoarthritis of the knee (OAK', 'Patients with Knee Osteoarthritis']",['Regular physical activity (PA'],"['OAK severity, BMI, and depressive symptoms', 'OAK severity (WOMAC), BMI, and depressive symptoms (CES-D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0330302', 'cui_str': 'Quercus'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0330302', 'cui_str': 'Quercus'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",243.0,0.0176824,"When health demands were higher, willpower beliefs were not associated with PA.
","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Di Maio', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany. sally.dimaio@fu-berlin.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Job', 'Affiliation': 'Faculty of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Center for Muscle and Bone Research, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Ertel', 'Affiliation': 'Department of Traumatology and Reconstructive Surgery, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Knoll', 'Affiliation': 'Department of Education and Psychology, Health Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, D-14195, Berlin, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09865-w']
487,31905041,Do Anesthesia Methods in Retrograde Intrarenal Surgery Make Difference Regarding the Success of Ureteral Access and Surgical Outcomes?,"Background:  Retrograde intrarenal surgery (RIRS) is a safe and minimally invasive method for the endoscopic treatment of upper urinary system stones especially sized <2 cm. Ureteral entrance is an important stage of RIRS. General anesthesia (GA) is usually used for RIRS. There is not enough data about the effect of anesthesia methods on the success of ureteral entrance and RIRS. We aimed to evaluate the effects of anesthesia methods (spinal anesthesia [SA], epidural anesthesia [EA], and GA) on the ureteral access and RIRS outcomes in primary surgery.  Methods:  After local ethical approval, 105 patients were prospectively randomized into three groups according to the anesthesia methods. GA, SA, and EA were defined as Group 1, 2, and 3, respectively.  Results:  Stone density was statistically significantly different between three groups ( P  = .008). Lithotripsy and operation time were significantly lower in Group 3 ( P  = .001). Dilatation and stone access time were significantly lower in Group 1. There was no statistically significant difference for scopy time, success, Visual Analog Scale score at 8th and 24th hours, and intraoperative and postoperative complications.  Conclusions:  GA may be recommended to decrease manipulations for the success of first ureteral access and time to reach the stone if there is not any contraindication.",2020,"There was no statistically significant difference for scopy time, success, Visual Analog Scale score at 8th and 24th hours, and intraoperative and postoperative complications.  ","['primary surgery', '105 patients']","['General anesthesia (GA', 'Retrograde intrarenal surgery (RIRS', 'anesthesia methods (spinal anesthesia [SA], epidural anesthesia [EA], and GA']","['GA, SA, and EA', 'Dilatation and stone access time', 'scopy time, success, Visual Analog Scale score at 8th and 24th hours, and intraoperative and postoperative complications', 'Lithotripsy and operation time', 'Stone density']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",105.0,0.0877694,"There was no statistically significant difference for scopy time, success, Visual Analog Scale score at 8th and 24th hours, and intraoperative and postoperative complications.  ","[{'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Oztekin', 'Affiliation': 'Department of Urology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Caniklioglu', 'Affiliation': 'Department of Urology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Selmi', 'Affiliation': 'Department of Urology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Cigdem Unal', 'Initials': 'CU', 'LastName': 'Kantekin', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Atac', 'Affiliation': 'Department of Urology, Faculty of Medicine, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Gurel', 'Affiliation': 'Department of Urology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Sari', 'Affiliation': 'Department of Urology, Faculty of Medicine, Bozok University, Yozgat, Turkey.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0548']
488,31393176,Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.,"Background:  The  G lycemia  R eduction  A pproaches in  D iabetes: A Comparative  E ffectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  Methods:  The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations.  Conclusions:  The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.",2019,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  ","['Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other', 'patients of different races or ethnicities', 'enrolled a racially and ethnically diverse population with type 2 diabetes', '1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared']",['CGM'],"['R eduction', 'average glucose (AG) and hemoglobin A1c (HbA1c']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",450.0,0.0248676,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups.  ","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Herman', 'Affiliation': 'Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Higgins', 'Affiliation': 'Department of Systems Biology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tiktin', 'Affiliation': 'Multidisciplinary Research, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Cincinnati VA Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Arends', 'Affiliation': 'Advanced Research and Diagnostic Laboratory, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0202']
489,32098739,Factors associated with referring close contacts to an app with individually-tailored vaccine information.,"BACKGROUND


Infants too young to be fully vaccinated are vulnerable to potentially deadly influenza and pertussis infections. The cocooning strategy limits this risk by vaccinating those likely to interact with the infant and mother during this vulnerable time, such as close friends and family members. Distribution of accurate and accessible vaccine information through existing social networks could be an important tool in increasing vaccine confidence and coverage.
METHODS


We surveyed 1095 pregnant women from diverse prenatal care practices in Georgia and Colorado. These women were surveyed through a mobile app to assess vaccine intentions, attitudes, beliefs, norms, and levels of trust, and then presented brief individually-tailored educational videos about maternal and infant vaccines and the cocooning strategy. They were then given the opportunity to refer up to six contacts to enroll in the app and receive similar vaccine education.
RESULTS


Twenty-eight percent of these women referred at least one contact, with an average of 2.67 contacts per referring woman. Most referrals (93%) were partners, parents, siblings, relatives, or close friends. Attitudinal constructs significantly associated with increased likelihood of referring contacts included: intention to receive maternal influenza vaccine, perceived safety of maternal Tdap vaccine, perceived efficacy of maternal influenza vaccine, perceived susceptibility to and severity of influenza during pregnancy, and trust in vaccine information from the Centers for Disease Control and Prevention (CDC) and academic institutions. Uncertainty about infant vaccine intentions was associated with decreased likelihood of referring contacts.
CONCLUSIONS


Pregnant women who valued vaccination and trusted vaccine information from academic institutions were more likely to refer an educational app about vaccines than those who did not. Further research is needed to determine the potential impact of this strategy on vaccine coverage when implemented on a large scale.
TRIAL REGISTRATION


The survey informing this article was part of a randomized controlled trial funded by the National Institutes of Health [clinicaltrials.gov registration number NCT02898688].",2020,"These women were surveyed through a mobile app to assess vaccine intentions, attitudes, beliefs, norms, and levels of trust, and then presented brief individually-tailored educational videos about maternal and infant vaccines and the cocooning strategy.","['Twenty-eight percent of these women referred at least one contact, with an average of 2.67 contacts per referring woman', '1095 pregnant women from diverse prenatal care practices in Georgia and Colorado', 'Pregnant women who valued vaccination and trusted vaccine information from academic institutions']",[],"['vaccine intentions, attitudes, beliefs, norms, and levels of trust']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]",[],"[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]",1095.0,0.111491,"These women were surveyed through a mobile app to assess vaccine intentions, attitudes, beliefs, norms, and levels of trust, and then presented brief individually-tailored educational videos about maternal and infant vaccines and the cocooning strategy.","[{'ForeName': 'Matthew Z', 'Initials': 'MZ', 'LastName': 'Dudley', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, United States. Electronic address: mattdudley@jhu.edu.'}, {'ForeName': 'Rupali J', 'Initials': 'RJ', 'LastName': 'Limaye', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, United States; Department of Health, Behavior and Society, Johns Hopkins University Bloomberg School of Public Health, United States; Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, United States.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Epidemiology of Microbial Diseases, Yale School of Public Health, Yale University, United States; Yale Institute for Global Health, United States; Yale School of Medicine, Infectious Diseases, Yale New Haven Hospital, United States.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, United States; Department of Pediatrics, University of Colorado Anschutz Medical Campus, United States.""}, {'ForeName': 'Mallory K', 'Initials': 'MK', 'LastName': 'Ellingson', 'Affiliation': 'Epidemiology of Microbial Diseases, Yale School of Public Health, Yale University, United States.'}, {'ForeName': 'Christine I', 'Initials': 'CI', 'LastName': 'Spina', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, United States.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Brewer', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, United States; Department of Family Medicine, University of Colorado Anschutz Medical Campus, United States.""}, {'ForeName': 'Allison T', 'Initials': 'AT', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bednarczyk', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, United States; Department of Epidemiology, Rollins School of Public Health, Emory University, United States; Emory Vaccine Center, Emory University, United States.'}, {'ForeName': 'Fauzia', 'Initials': 'F', 'LastName': 'Malik', 'Affiliation': 'Yale School of Medicine, Infectious Diseases, Yale New Haven Hospital, United States; Global Health Leadership Initiative, Health Policy and Management, Yale School of Public Health, Yale University, United States.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Frew', 'Affiliation': 'School of Public Health, University of Nevada, Las Vegas, United States; School of Medicine, University of Nevada, Las Vegas, United States; Population Health & Health Equity Initiative, University of Nevada, Las Vegas, United States.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Salmon', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, United States; Department of Health, Behavior and Society, Johns Hopkins University Bloomberg School of Public Health, United States; Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.02.019']
490,31467047,"Factors associated with maternity waiting home use among women in Jimma Zone, Ethiopia: a multilevel cross-sectional analysis.","OBJECTIVE


To identify individual-, household- and community-level factors associated with maternity waiting home (MWH) use in Ethiopia.
DESIGN


Cross-sectional analysis of baseline household survey data from an ongoing cluster-randomised controlled trial using multilevel analyses.
SETTING


Twenty-four rural primary care facility catchment areas in Jimma Zone, Ethiopia.
PARTICIPANTS


3784 women who had a pregnancy outcome (live birth, stillbirth, spontaneous/induced abortion) 12 months prior to September 2016.
OUTCOME MEASURE


The primary outcome was self-reported MWH use for any pregnancy; hypothesised factors associated with MWH use included woman's education, woman's occupation, household wealth, involvement in health-related decision-making, companion support, travel time to health facility and community-levels of institutional births.
RESULTS


Overall, 7% of women reported past MWH use. Housewives (OR: 1.74, 95% CI 1.20 to 2.52), women with companions for facility visits (OR: 2.15, 95% CI 1.44 to 3.23), wealthier households (fourth vs first quintile OR: 3.20, 95% CI 1.93 to 5.33) and those with no health facility nearby or living >30 min from a health facility (OR: 2.37, 95% CI 1.80 to 3.13) had significantly higher odds of MWH use. Education, decision-making autonomy and community-level institutional births were not significantly associated with MWH use.
CONCLUSIONS


Utilisation inequities exist; women with less wealth and companion support experienced more difficulties in accessing MWHs. Short duration of stay and failure to consider MWH as part of birth preparedness planning suggests local referral and promotion practices need investigation to ensure that women who would benefit the most are linked to MWH services.",2019,"Housewives (OR: 1.74, 95% CI 1.20 to 2.52), women with companions for facility visits (","['Twenty-four rural primary care facility catchment areas in Jimma Zone, Ethiopia', 'women with companions for facility visits ', '3784 women who had a pregnancy outcome (live birth, stillbirth, spontaneous/induced abortion) 12 months prior to September 2016']",['maternity waiting home (MWH'],"[""self-reported MWH use for any pregnancy; hypothesised factors associated with MWH use included woman's education, woman's occupation, household wealth, involvement in health-related decision-making, companion support, travel time to health facility and community-levels of institutional births""]","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",3784.0,0.129463,"Housewives (OR: 1.74, 95% CI 1.20 to 2.52), women with companions for facility visits (","[{'ForeName': 'Jaameeta', 'Initials': 'J', 'LastName': 'Kurji', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada jkurj022@uottawa.ca.'}, {'ForeName': 'Lakew Abebe', 'Initials': 'LA', 'LastName': 'Gebretsadik', 'Affiliation': 'Department of Health, Behaviour and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Muluemebet Abera', 'Initials': 'MA', 'LastName': 'Wordofa', 'Affiliation': 'Department of Population and Family Health, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Morankar', 'Initials': 'M', 'LastName': 'Sudhakar', 'Affiliation': 'Department of Health, Behaviour and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Yisalemush', 'Initials': 'Y', 'LastName': 'Asefa', 'Affiliation': 'Department of Health Economics, Management and Policy, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Getachew', 'Initials': 'G', 'LastName': 'Kiros', 'Affiliation': 'Department of Health, Behaviour and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Abebe', 'Initials': 'A', 'LastName': 'Mamo', 'Affiliation': 'Department of Health, Behaviour and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bergen', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shifera', 'Initials': 'S', 'LastName': 'Asfaw', 'Affiliation': 'Department of Health, Behaviour and Society, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Kunuz Haji', 'Initials': 'KH', 'LastName': 'Bedru', 'Affiliation': 'Jimma Zone Health Office, Jimma, Ethiopia.'}, {'ForeName': 'Gebeyehu', 'Initials': 'G', 'LastName': 'Bulcha', 'Affiliation': 'Jimma Zone Health Office, Jimma, Ethiopia.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Labonte', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Faculty of Medicine, Ottawa, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-028210']
491,31427346,Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy.,"INTRODUCTION


One in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.
METHODS AND ANALYSIS


A two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women's mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.
ETHICS AND DISSEMINATION


Study results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.
TRIAL REGISTRATION NUMBER


ISRCTN11513120.",2019,"It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage).","['Women with depression', 'antenatal depression', 'pregnant women with depression in a feasibility study', '60 women will be conducted in two UK localities', 'eight women suffer from depression during pregnancy']","['interpersonal counselling with cognitive behavioural therapy', 'low-intensity interventions', 'CBT', 'CBT and IPC', 'IPC or CBT', 'Interpersonal counselling (IPC', 'cognitive behavioural therapy (CBT']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]",[],60.0,0.240523,"It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage).","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK jenny.ingram@bristol.ac.uk.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': ""O'Mahen"", 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Law', 'Affiliation': 'Anna Freud Centre, London, UK.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Round', 'Affiliation': 'Institute of Health Economics, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hopley', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Glynn', 'Affiliation': 'Health Economics Bristol, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Culpin', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032649']
492,32146550,Phase I study of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced epithelial ovarian cancer.,"Background Metformin use is associated with reduced cancer risk in epidemiological studies and has preclinical anti-cancer activity in ovarian cancer models. The primary objective of this phase I study was to determine the recommended phase II dose (RP2D) of metformin in combination with carboplatin/paclitaxel in patients with ovarian cancer. Secondary objectives were to describe safety and pharmacokinetics. Methods In this single-center trial the RP2D of metformin in combination with carboplatin area under the concentration-time curve (AUC) 6 and paclitaxel 175 mg/m 2  every 3 weeks (q3w) in patients with advanced epithelial ovarian cancer was determined using a 3 + 3 escalation rule at three fixed dose levels: 500 mg three times daily (tds), 850 mg tds and 1000 mg tds. Metformin was commenced on day 3 of cycle 1 and continued until 3 weeks after the last chemotherapy administration. The RP2D was defined as the dose level at which 0 of 3 or ≤ 1 of 6 evaluable subjects experienced a metformin-related dose-limiting toxicity (DLT). Safety was assessed according to CTCAE v4.0. Plasma and serum samples for pharmacokinetic (PK) analyses were collected during treatment cycles 1 and 2. Results Fifteen patients with epithelial ovarian cancer and an indication for neo-adjuvant (n = 5) or palliative (n = 10) treatment were included. No DLTs were observed. Three patients discontinued study treatment during cycle 1 for other reasons than DLT. Six patients were treated at the RP2D of metformin 1000 mg tds. The most frequent low-grade toxicities were anemia, hypomagnesemia and diarrhea. Grade 3 adverse events (AEs) occurred in ten patients, most common were leucopenia (n = 4), thrombocytopenia (n = 3) and increased GGT (n = 3). There were no grade 4 AEs. Metformin increased the platinum (Pt) AUC (Δ22%, p = 0.013) and decreased the Pt clearance (Δ-28%, p = 0.013). Metformin plasma levels were all within the therapeutic range for diabetic patients (0.1-4 mg/L). Conclusion The RP2D of metformin in combination with carboplatin and paclitaxel in advanced ovarian cancer is 1000 mg tds. This is higher than the RP2D reported for combination with targeted agents. A potential PK interaction of metformin with carboplatin was identified.",2020,"Metformin increased the platinum (Pt) AUC (Δ22%, p = 0.013) and decreased the Pt clearance (Δ-28%, p = 0.013).","['Fifteen patients with epithelial ovarian cancer and an indication for neo-adjuvant (n\u2009=\u20095) or palliative (n\u2009=\u200910) treatment were included', 'patients with ovarian cancer', 'patients with advanced epithelial ovarian cancer']","['carboplatin/paclitaxel', 'Metformin', 'carboplatin and paclitaxel', ' Metformin', 'metformin', 'carboplatin/paclitaxel chemotherapy', 'metformin with carboplatin']","['Pt clearance', 'thrombocytopenia', 'Grade 3 adverse events (AEs', 'Plasma and serum samples for pharmacokinetic (PK) analyses', 'platinum (Pt) AUC', 'Metformin plasma levels', 'anemia, hypomagnesemia and diarrhea', 'safety and pharmacokinetics', 'Safety', 'leucopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",15.0,0.0300478,"Metformin increased the platinum (Pt) AUC (Δ22%, p = 0.013) and decreased the Pt clearance (Δ-28%, p = 0.013).","[{'ForeName': 'K Esther', 'Initials': 'KE', 'LastName': 'Broekman', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, the Netherlands.'}, {'ForeName': 'Marieke A J', 'Initials': 'MAJ', 'LastName': 'Hof', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jourik A', 'Initials': 'JA', 'LastName': 'Gietema', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, the Netherlands.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Joop D', 'Initials': 'JD', 'LastName': 'Lefrandt', 'Affiliation': 'Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'An K L', 'Initials': 'AKL', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, the Netherlands.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Jalving', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, the Netherlands. m.jalving@umcg.nl.'}]",Investigational new drugs,['10.1007/s10637-020-00920-7']
493,31691305,Effects of cognitive behavioural therapy and return-to-work intervention for patients on sick leave due to stress-related disorders: Results from a randomized trial.,"The aim of this study was to evaluate specific effects for patients with adjustment or exhaustion disorder, the Stress subgroup (n = 152), regarding symptom severity and sick leave after CBT, a return-to-work intervention (RTW-I), and a combination of them (COMBO), using data from a randomized trial. In the original study, primary care patients on sick leave (N = 211) were randomized to CBT (n = 64), RTW-I (n = 67), or COMBO (n = 80). Blinded Clinician Severity Rating (CSR) of symptoms and sick leave registry data were primary outcomes. Subgroup analyses showed that for the Stress subgroup, CBT led to greater reduction of symptoms than RTW-I posttreatment, but COMBO did not differ from CBT or RTW-I. Regarding sick leave, there was no difference between treatments in the Stress subgroup. An exploratory analysis of the treatment effects in a subgroup of patients with depression, anxiety or insomnia indicates that RTW-I reduced sick leave faster than CBT. We conclude that CBT may be promising as an effective treatment of stress and exhaustion disorder.",2020,"Subgroup analyses showed that for the Stress subgroup, CBT led to greater reduction of symptoms than RTW-I posttreatment, but COMBO did not differ from CBT or RTW-I.","['primary care patients on sick leave (N\xa0=\xa0211', 'patients with adjustment or exhaustion disorder, the Stress subgroup (n\xa0=\xa0152), regarding symptom severity and sick leave after CBT, a return-to-work intervention (RTW-I), and a combination of them (COMBO), using data from a randomized trial', 'patients on sick leave due to stress-related disorders', 'patients with depression, anxiety or insomnia indicates that RTW-I reduced sick leave faster than CBT']","['cognitive behavioural therapy and return-to-work intervention', 'CBT']","['Blinded Clinician Severity Rating (CSR) of symptoms and sick leave registry data', 'COMBO', 'specific effects']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.143882,"Subgroup analyses showed that for the Stress subgroup, CBT led to greater reduction of symptoms than RTW-I posttreatment, but COMBO did not differ from CBT or RTW-I.","[{'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Salomonsson', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Santoft', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Lindsäter', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kersti', 'Initials': 'K', 'LastName': 'Ejeby', 'Affiliation': 'Department of Neurobiology, Division of Family medicine, Care Sciences and Society (NVS), H1, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ingvar', 'Affiliation': 'Department of Clinical Neuroscience, Osher Center for Integrative Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lars-Göran', 'Initials': 'LG', 'LastName': 'Öst', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Osher Center for Integrative Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}]",Scandinavian journal of psychology,['10.1111/sjop.12590']
494,31780589,Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction).,"INTRODUCTION


Antipsychotic medication is effective in reducing acute symptoms of psychosis, but it has a range of potentially serious and debilitating adverse effects and is often disliked by patients. It is therefore essential it is only used when benefits outweigh harms. Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.
METHODS AND ANALYSIS


This is a multicentre, randomised controlled trial involving people with schizophrenia and related disorders who have had more than one episode. Participants are randomised to have a clinically-supervised, gradual reduction of antipsychotic medication, leading to discontinuation when possible, or to continue with maintenance treatment. Blinded follow-up assessments are conducted at 6, 12 and 24 months and the primary outcome is social functioning, measured by the Social Functioning Scale at 24 months. A minimum of 134 evaluable participants provides 90% power to detect a five-point difference, and 206 to detect a four-point difference. Secondary outcomes include severe relapse (admission to hospital) and the study is also intended to detect a minimum 10% difference in severe relapse, which requires 402 participants, assuming a 15% loss to follow-up. Other secondary outcomes include all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures. Enrolment started in 2016. The trial is scheduled to finish in June 2022.
ETHICS AND DISSEMINATION


Ethical approval was initially obtained on 27 October 2016 (UK Research Ethics Committee reference 16/LO/1507). Results will be published in peer-reviewed journals and disseminated to the public.
TRIAL REGISTRATION NUMBER


ISRCTN90298520. EudraCT: 2016-000709-36. Pre-results.",2019,"Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.
","['people with schizophrenia and related disorders', 'people with schizophrenia and related disorders who have had more than one episode', '134 evaluable participants']","['EudraCT', 'Antipsychotic medication', 'gradual antipsychotic reduction and discontinuation']","['social functioning, measured by the Social Functioning Scale', 'severe relapse', 'all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures', 'severe relapse (admission to hospital', 'risk of relapse']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale (assessment scale)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",402.0,0.166369,"Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moncrieff', 'Affiliation': 'Division of Psychiatry, University College London and North East London NHS Foundation Trust, London, UK j.moncrieff@ucl.ac.uk.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Institute for Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Thomas R E', 'Initials': 'TRE', 'LastName': 'Barnes', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morant', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pinfold', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Lyn J', 'Initials': 'LJ', 'LastName': 'Kent', 'Affiliation': 'Independent consultant, Brentwood, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Independent consultant, Brighton, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Darton', 'Affiliation': 'Independent consultant, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Nadia E', 'Initials': 'NE', 'LastName': 'Crellin', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Cooper', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Louise', 'Initials': '', 'LastName': 'Marston', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit for Social and Community Psychiatry, Queen Mary University of London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030912']
495,31462466,Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial.,"INTRODUCTION


Type 1 diabetes mellitus (T1DM) is one of the most frequent chronic endocrine diseases in the paediatric population. As a result, this disease has a strong impact on psychological well-being. In line with this, emotional factors play an important role in adaptation. The aim of the present study protocol is to design an emotional abilities programme to improve metabolic control assessed by haemoglobin A1c (HbA1c) samples. Specifically, this intervention will be focused on adaptive coping strategies to deal with unpleasant emotions associated with T1DM. The primary aim of this project is to assess whether the employment of this new psychological intervention improves the emotional abilities of adolescents with T1DM.
METHODS AND ANALYSIS


Two focus groups will be carried out for the design and evaluation of the programme following the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects/safety and equity). Behavioural change will be based on the Behaviour Change Wheel. Sixty-two participants from 12 to 18 years of age will be recruited at a public hospital and randomised to either an intervention or a control group. The intervention group will receive an emotional abilities training programme. The control group will receive usual educational intervention. The primary outcomes are metabolic control and emotional abilities. The secondary outcomes include emotional distress control, positive and negative affect, healthy habits, and quality of life. Data will be collected at baseline, immediately postintervention, and at follow-up visits at 6 and 12 months. A feasibility analysis will be conducted.
ETHICS AND DISSEMINATION


The study has been approved by the Ethics Committee of Universidad Loyola Andalucía. Results will be submitted for publication in peer-reviewed journals and disseminated across the scientific community.
TRIAL REGISTRATION NUMBER


NCT03734367.",2019,"The primary aim of this project is to assess whether the employment of this new psychological intervention improves the emotional abilities of adolescents with T1DM.
","['adolescents with T1DM', 'adolescents with type 1 diabetes mellitus in a hospital setting', 'Sixty-two participants from 12 to 18 years of age will be recruited at a public hospital and randomised to either an intervention or a control group']","['psychological intervention', 'emotional abilities training programme', 'usual educational intervention']","['emotional abilities', 'metabolic control and emotional abilities', 'practicability, effectiveness, acceptability, side effects/safety and equity', 'emotional distress control, positive and negative affect, healthy habits, and quality of life', 'metabolic control assessed by haemoglobin A1c (HbA1c) samples']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0034380'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",62.0,0.129172,"The primary aim of this project is to assess whether the employment of this new psychological intervention improves the emotional abilities of adolescents with T1DM.
","[{'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Ruiz-Aranda', 'Affiliation': 'Psychology, Universidad Loyola Adalucia, Seville, Spain.'}, {'ForeName': 'Davinia M', 'Initials': 'DM', 'LastName': 'Resurrección', 'Affiliation': 'Psychology, Universidad Loyola Adalucia, Seville, Spain dmresurreccion@uloyola.es.'}, {'ForeName': 'Mencia R', 'Initials': 'MR', 'LastName': 'Gutierrez-Colosia', 'Affiliation': 'Psychology, Universidad Loyola Adalucia, Seville, Spain.'}, {'ForeName': 'Maria Asuncion', 'Initials': 'MA', 'LastName': 'Martinez-Brocca', 'Affiliation': 'UGC Endocrinología y Nutrición, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}]",BMJ open,['10.1136/bmjopen-2018-027913']
496,31462489,Automated virtual reality (VR) cognitive therapy for patients with psychosis: study protocol for a single-blind parallel group randomised controlled trial (gameChange).,"INTRODUCTION


Many patients with psychosis experience everyday social situations as anxiety-provoking. The fears can arise, for example, from paranoia, hallucinations, social anxiety or negative-self beliefs. The fears lead patients to withdraw from activities, and this isolation leads to a cycle of worsening physical and mental health. Breaking this cycle requires highly active treatment directly in the troubling situations so that patients learn that they can safely and confidently enter them. However patients with psychosis seldom receive such life-changing interventions. To solve this problem we have developed an automated psychological treatment delivered in virtual reality (VR). It allows patients to experience computer simulations of the situations that they find anxiety-provoking. A virtual coach guides patients, using cognitive techniques, in how to overcome their fears. Patients are willing to enter VR simulations of anxiety-provoking situations because they know the simulations are not real, but the learning made transfers to the real world.
METHODS AND ANALYSIS


432 patients with psychosis and anxious avoidance of social situations will be recruited from National Health Service (NHS) secondary care services. In the gameChange trial, they will be randomised (1:1) to the six-session VR cognitive treatment added to treatment as usual or treatment as usual alone. Assessments will be conducted at 0, 6 (post-treatment) and 26 weeks by a researcher blind to allocation. The primary outcome is avoidance and distress in real-life situations, using a behavioural assessment task, at 6 weeks. The secondary outcomes are psychiatric symptoms, activity levels and quality of life. All main analyses will be intention-to-treat. Moderation and mediation will be tested. An economic evaluation will be conducted.
ETHICS AND DISSEMINATION


The trial has received ethical approval from the NHS South Central - Oxford B Research Ethics Committee (19/SC/0075). A key output will be a high-quality automated VR treatment for patients to overcome anxious avoidance of social situations.
TRIAL REGISTRATION NUMBER


ISRCTN17308399.",2019,"In the gameChange trial, they will be randomised (1:1) to the six-session VR cognitive treatment added to treatment as usual or treatment as usual alone.","['patients with psychosis', 'patients with psychosis experience everyday social situations as anxiety-provoking', '432 patients with psychosis and anxious avoidance of social situations will be recruited from National Health Service (NHS) secondary care services']",['Automated virtual reality (VR) cognitive therapy'],"['avoidance and distress in real-life situations, using a behavioural assessment task', 'psychiatric symptoms, activity levels and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}]",432.0,0.127896,"In the gameChange trial, they will be randomised (1:1) to the six-session VR cognitive treatment added to treatment as usual or treatment as usual alone.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK daniel.freeman@psych.ox.ac.uk.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Primary Care Clinical Trials Unit, Nuffield Department of Primary care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kabir', 'Affiliation': 'The McPin Foundation, London, UK.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'NIHR MindTech, Institute of Mental Health, Division of Psychiatry & Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Craven', 'Affiliation': 'NIHR MindTech, Institute of Mental Health, Division of Psychiatry & Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Lambe', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'NIHR MindTech, Institute of Mental Health, Division of Psychiatry & Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Greater Manchester Mental Health Foundation Trust, Manchester, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': 'Avon and Wiltshire Mental Health Partnership (AWP) NHS Trust, Bath, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dudley', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Regan"", 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Rovira', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodsell', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Laina', 'Initials': 'L', 'LastName': 'Rosebrock', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aislinn', 'Initials': 'A', 'LastName': 'Bergin', 'Affiliation': 'NIHR MindTech, Institute of Mental Health, Division of Psychiatry & Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Tillie L', 'Initials': 'TL', 'LastName': 'Cryer', 'Affiliation': 'The McPin Foundation, London, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Robotham', 'Affiliation': 'The McPin Foundation, London, UK.'}, {'ForeName': 'Humma', 'Initials': 'H', 'LastName': 'Andleeb', 'Affiliation': 'The McPin Foundation, London, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Geddes', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'NIHR MindTech, Institute of Mental Health, Division of Psychiatry & Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Clark', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Waite', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031606']
497,30916641,Sexual risk reduction interventions for patients attending sexual health clinics: a mixed-methods feasibility study.,"BACKGROUND


Sexually transmitted infections (STIs) continue to represent a major public health challenge. There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services. However, it is not known if these interventions are effective when implemented at scale in SH settings in England.
OBJECTIVES


The study (Santé) had two main objectives - (1) to develop and pilot a package of evidence-based sexual risk reduction interventions that can be delivered through SH services and (2) to assess the feasibility of conducting a randomised controlled trial (RCT) to determine effectiveness against usual care.
DESIGN


The project was a multistage, mixed-methods study, with developmental and pilot RCT phases. Preparatory work included a systematic review, an analysis of national surveillance data, the development of a triage algorithm, and interviews and surveys with SH staff and patients to identify, select and adapt interventions. A pilot cluster RCT was planned for eight SH clinics; the intervention would be offered in four clinics, with qualitative and process evaluation to assess feasibility and acceptability. Four clinics acted as controls; in all clinics, participants would be consented to a 6-week follow-up STI screen.
SETTING


SH clinics in England.
PARTICIPANTS


Young people (aged 16-25 years), and men who have sex with men.
INTERVENTION


A three-part intervention package - (1) a triage tool to score patients as being at high or low risk of STI using routine data, (2) a study-designed web page with tailored SH information for all patients, regardless of risk and (3) a brief one-to-one session based on motivational interviewing for high-risk patients.
MAIN OUTCOME MEASURES


The three outcomes were (1) the acceptability of the intervention to patients and SH providers, (2) the feasibility of delivering the interventions within existing resources and (3) the feasibility of obtaining follow-up data on STI diagnoses (primary outcome in a full trial).
RESULTS


We identified 33 relevant trials from the systematic review, including videos, peer support, digital and brief one-to-one sessions. Patients and SH providers showed preferences for one-to-one and digital interventions, and providers indicated that these intervention types could feasibly be implemented in their settings. There were no appropriate digital interventions that could be adapted in time for the pilot; therefore, we created a placeholder for the purposes of the pilot. The intervention package was piloted in two SH settings, rather than the planned four. Several barriers were found to intervention implementation, including a lack of trained staff time and clinic space. The intervention package was theoretically acceptable, but we observed poor engagement. We recruited patients from six clinics for the follow-up, rather than eight. The completion rate for follow-up was lower than anticipated (16% vs. 46%).
LIMITATIONS


Fewer clinics were included in the pilot than planned, limiting the ability to make strong conclusions on the feasibility of the RCT.
CONCLUSION


We were unable to conclude whether or not a definitive RCT would be feasible because of challenges in implementation of a pilot, but have laid the groundwork for future research in the area.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN16738765.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 12. See the NIHR Journals Library website for further project information.",2019,There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services.,"['Young people (aged 16-25 years), and men who have sex with men', 'patients attending sexual health clinics', 'SH clinics in England', 'patients attending sexual health (SH) services', 'recruited patients from six clinics for the follow-up, rather than eight']","['brief one-to-one session based on motivational interviewing', 'Sexual risk reduction interventions']","['STI rates', 'risky sexual behaviours', 'completion rate']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0603458,There is evidence that behavioural interventions to reduce risky sexual behaviours can reduce STI rates in patients attending sexual health (SH) services.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'King', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Llewellyn', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Burns', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Howarth', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Gwenda', 'Initials': 'G', 'LastName': 'Hughes', 'Affiliation': 'Sexually Transmitted Infection Surveillance, Public Health England, London, UK.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Miners', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Pollard', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Rodger', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23120']
498,31063156,Keratinocyte growth factor impairs human thymic recovery from lymphopenia.,"BACKGROUND


The lymphocyte-depleting antibody alemtuzumab is a highly effective treatment of relapsing-remitting multiple sclerosis (RRMS); however 50% of patients develop novel autoimmunity post-treatment. Most at risk are individuals who reconstitute their T-cell pool by proliferating residual cells, rather than producing new T-cells in the thymus; raising the possibility that autoimmunity might be prevented by increasing thymopoiesis. Keratinocyte growth factor (palifermin) promotes thymopoiesis in non-human primates.
METHODS


Following a dose-tolerability sub-study, individuals with RRMS (duration ≤10 years; expanded disability status scale ≤5·0; with ≥2 relapses in the previous 2 years) were randomised to placebo or 180mcg/kg/day palifermin, given for 3 days immediately prior to and after each cycle of alemtuzumab, with repeat doses at M1 and M3. The interim primary endpoint was naïve CD4+ T-cell count at M6. Exploratory endpoints included: number of recent thymic-emigrants (RTEs) and signal-joint T-cell receptor excision circles (sjTRECs)/mL of blood. The trial primary endpoint was incidence of autoimmunity at M30.
FINDINGS


At M6, individuals receiving palifermin had fewer naïve CD4+T-cells (2.229x107/L vs. 7.733x107/L; p=0.007), RTEs (16% vs. 34%) and sjTRECs/mL (1100 vs. 3396), leading to protocol-defined termination of recruitment. No difference was observed in the rate of autoimmunity between the two groupsConclusion: In contrast to animal studies, palifermin reduced thymopoiesis in our patients. These results offer a note of caution to those using palifermin to promote thymopoiesis in other settings, particularly in the oncology/haematology setting where alemtuzumab is often used as part of the conditioning regime.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01712945Funding: MRC and Moulton Charitable Foundation.",2019,"At M6, individuals receiving palifermin had fewer naïve CD4+T-cells (2.229x107/L vs. 7.733x107/L; p=0.007), RTEs (16% vs. 34%) and sjTRECs/mL (1100 vs. 3396), leading to protocol-defined termination of recruitment.",['individuals with RRMS (duration ≤10 years; expanded disability status scale ≤5·0; with ≥2 relapses in the previous 2 years'],"['placebo or 180mcg/kg/day palifermin', 'Keratinocyte growth factor (palifermin', 'palifermin']","['incidence of autoimmunity at M30', 'rate of autoimmunity', 'naïve CD4+T-cells', 'number of recent thymic-emigrants (RTEs) and signal-joint T-cell receptor excision circles (sjTRECs)/mL of blood', 'naïve CD4+ T-cell count at M6']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0677829', 'cui_str': 'Palifermin'}, {'cui': 'C0064294', 'cui_str': 'Fibroblast Growth Factor 7'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004368', 'cui_str': 'Autoimmunity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1955873', 'cui_str': 'Emigrants'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}, {'cui': 'C0005768'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0385008,"At M6, individuals receiving palifermin had fewer naïve CD4+T-cells (2.229x107/L vs. 7.733x107/L; p=0.007), RTEs (16% vs. 34%) and sjTRECs/mL (1100 vs. 3396), leading to protocol-defined termination of recruitment.","[{'ForeName': 'Alasdair J', 'Initials': 'AJ', 'LastName': 'Coles', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Azzopardi', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Onajite', 'Initials': 'O', 'LastName': 'Kousin-Ezewu', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Harpreet Kaur', 'Initials': 'HK', 'LastName': 'Mullay', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sara Aj', 'Initials': 'SA', 'LastName': 'Thompson', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Jarvis', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Howlett', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rainbow', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Babar', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Sadler', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'J William L', 'Initials': 'JWL', 'LastName': 'Brown', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Needham', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'May', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Zoya G', 'Initials': 'ZG', 'LastName': 'Georgieva', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Adam E', 'Initials': 'AE', 'LastName': 'Handel', 'Affiliation': 'Nuffield Department of Clinical Neurosciences and.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Maio', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Deadman', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Rota', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Holländer', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dawson', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Seggewiss-Bernhardt', 'Affiliation': 'University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Douek', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Isaacs', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, and Musculoskeletal Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.'}]",JCI insight,['10.1172/jci.insight.125377']
499,30813767,Evaluation of a breathing retraining intervention to improve quality of life in asthma: quantitative process analysis of the BREATHE randomized controlled trial.,"OBJECTIVE


Explore qualitative differences between interventions (DVD and booklet (DVDB) versus face-to-face and booklet (F2FB) versus usual care) in the BREATHE (Breathing Retraining for Asthma Trial of Home Exercises) trial of breathing retraining for asthma.
DESIGN


Quantitative process analysis exploring group expectancy, experience and practice before and after intervention delivery for the main trial.
SETTING


Primary care.
SUBJECTS


Adults with asthma (DVD and booklet,  n  = 261; F2FB,  n  = 132).
MAIN MEASURES


Baseline - expectancy about breathing retraining; follow-up 3, 6 and 12 months - self-efficacy, treatment experience (enjoyment of treatment, perceptions of physiotherapist, perceptions of barriers), amount of practice (weeks, days/week, times/day), continued practice; all time points - anxiety (Hospital Anxiety and Depression Scale), AQLQ (Asthma Quality of Life Questionnaire).
RESULTS


No group differences in baseline expectancy. Statistically significant results ( P  < 0.05) indicated that at follow-up, F2FB participants perceived greater need for a physiotherapist than DVD and booklet participants (3.43 (0.87) versus 2.15 (1.26)). F2FB participants reported greater enjoyment of core techniques (such as stomach breathing: 7.42 (1.67) versus 6.13 (1.99) (DVD and booklet)). Fewer F2FB participants reported problems due to doubts (24 (22.9%) versus 90 (54.2%)). F2FB participants completed more practice sessions (75.01 (46.38) versus 48.56 (44.71)). Amount of practice was not significantly related to quality of life. In the DVD and booklet arm, greater confidence in breathing retraining ability explained 3.9% of variance in quality of life at 12 months.
CONCLUSION


Adults with asthma receiving breathing retraining face-to-face report greater enjoyment and undertaking more practice than those receiving a DVD and booklet. Greater confidence in ability to do breathing retraining is associated with improved QoL.",2019,"In the DVD and booklet arm, greater confidence in breathing retraining ability explained 3.9% of variance in quality of life at 12 months.
","['asthma', 'Adults with asthma receiving breathing retraining face', 'Adults with asthma (DVD and booklet,  n \u2009=\u2009261; F2FB,  n \u2009=\u2009132']","['breathing retraining', 'F2FB', 'interventions (DVD and booklet (DVDB) versus face-to-face and booklet (F2FB) versus usual care', 'breathing retraining intervention']","['enjoyment of core techniques', 'all time points - anxiety (Hospital Anxiety and Depression Scale), AQLQ (Asthma Quality of Life Questionnaire', 'quality of life', 'baseline expectancy', 'Baseline - expectancy about breathing retraining; follow-up 3, 6 and 12\u2009months - self-efficacy, treatment experience (enjoyment of treatment, perceptions of physiotherapist, perceptions of barriers), amount of practice (weeks, days/week, times/day), continued practice']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0439511', 'cui_str': 'times/day (qualifier value)'}]",,0.0715323,"In the DVD and booklet arm, greater confidence in breathing retraining ability explained 3.9% of variance in quality of life at 12 months.
","[{'ForeName': 'Emily Julia', 'Initials': 'EJ', 'LastName': 'Arden-Close', 'Affiliation': '1 Department of Psychology, Bournemouth University, Poole, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Kirby', 'Affiliation': '2 Academic Unit of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': '2 Academic Unit of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bruton', 'Affiliation': '4 Faculty of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ainsworth', 'Affiliation': '2 Academic Unit of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'D Mike', 'Initials': 'DM', 'LastName': 'Thomas', 'Affiliation': '5 Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}]",Clinical rehabilitation,['10.1177/0269215519832942']
500,30925074,Views of children with cerebral palsy and their parents on the effectiveness and acceptability of intensive speech therapy.,"Purpose:  To understand children and parents' views of the effectiveness and acceptability of intensive dysarthria therapy. Materials and Methods:  Twenty-two children with cerebral palsy and dysarthria joined a pilot RCT comparing intensive therapy and usual care. Children ( n  = 11) allocated to dysarthria therapy comprising three 40-minute sessions per week for six weeks and their parents ( n  = 11) were interviewed two weeks before and six weeks after therapy. Interviews were transcribed verbatim and analysed thematically. Results:  Analysis revealed five themes: Motivations, My new voice; The new me; I can do more; Success rooted in therapy design. Children had received little therapy for speech and were keen to improve intelligibility. Overall, therapy was viewed as effective. Participants described changes in children's speech production, which they associated with increased speech intelligibility. Children were described as more confident following the therapy, to have more successful conversations, with a wider range of partners in more environments, thereby increasing their social participation. The programme was viewed as acceptable, despite its intensity, due to the short term commitment and wider benefits for the child. Parents valued the organised structure and individualisation of the programme and inclusion in the therapy process. Conclusion:  Families found the intervention acceptable and effective. A definitive trial of its clinical effectiveness is warranted.Implications for rehabilitationChildren with cerebral palsy who have dysarthria and their parents reported that intensive speech therapy focussing on creating a stronger voice and a steady speech rate increased the clarity of children's voice and the intelligibility of their speech.Therapy may have additional benefits for children's self-confidence and social participation.The programme of therapy comprising three sessions per week for six weeks was seen as manageable by families in view of the results achieved.",2020,"Children were described as more confident following the therapy, to have more successful conversations, with a wider range of partners in more environments, thereby increasing their social participation.","['rehabilitation Children with cerebral palsy who have dysarthria and their parents', 'Children (n\u2009=\u200911) allocated to', 'Twenty-two children with cerebral palsy and dysarthria joined a pilot RCT comparing intensive therapy and usual care', 'children with cerebral palsy and their parents']","['intensive dysarthria therapy', 'dysarthria therapy', 'intensive speech therapy']","['intelligibility', 'speech intelligibility', ""children's speech production""]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0013362', 'cui_str': 'Dysarthosis'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013362', 'cui_str': 'Dysarthosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}]","[{'cui': 'C0589416', 'cui_str': 'Intelligibility, function (observable entity)'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0033268'}]",22.0,0.0227969,"Children were described as more confident following the therapy, to have more successful conversations, with a wider range of partners in more environments, thereby increasing their social participation.","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pennington', 'Affiliation': 'Institute of Health and Society, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Rauch', 'Affiliation': 'Institute of Health and Society, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Institute of Health and Society, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Brittain', 'Affiliation': 'Department of Nursing, Midwifery & Health, Northumbria University, Newcastle Upon Tyne, UK.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1577504']
501,30753368,"Impact of Rotavirus Vaccine Introduction in Children Less Than 2 Years of Age Presenting for Medical Care With Diarrhea in Rural Matlab, Bangladesh.","BACKGROUND


Following the conclusion of a human rotavirus vaccine (HRV) cluster-randomized, controlled trial (CRT) in Matlab, Bangladesh, HRV was included in Matlab's routine immunization program. We describe the population-level impact of programmatic rotavirus vaccination in Bangladesh in children <2 years of age.
METHODS


Interrupted time series were used to estimate the impact of HRV introduction. We used diarrheal surveillance collected between 2000 and 2014 within the 2 service delivery areas (International Centre for Diarrhoeal Disease Research, Bangladesh [icddr,b] service area [ISA] and government service area [GSA]) of the Matlab Health and Demographic Surveillance System, administered by icddr,b. Age group-specific incidence rates were calculated for both rotavirus-positive (RV+) and rotavirus-negative (RV-) diarrhea diagnoses of any severity presenting to the hospital. We used 2 models to assess the impact within each service area: Model 1 used the pre-vaccine time period in all villages (HRV- and control-only) and Model 2 combined the pre-vaccine time period and the CRT time period, using outcomes from control-only villages.
RESULTS


Both models demonstrated a downward trend in RV+ diarrheal incidences in the ISA villages during 3.5 years of routine HRV use, though only Model 2 was statistically significant. Significant impacts of HRV on RV+ diarrhea incidences in GSA villages were not observed in either model. Differences in population-level impacts between the 2 delivery areas may be due to the varied rotavirus vaccine coverage and presentation rates to the hospital.
CONCLUSIONS


This study provides initial evidence of the population-level impact of rotavirus vaccines in children <2 years of age in Matlab, Bangladesh. Further studies are needed of the rotavirus vaccine impact after the nationwide introduction in Bangladesh.",2019,Significant impact of HRV on RV+ diarrhea incidence in GSA villages was not observed in either model.,"['children <2 years of age in Matlab, Bangladesh', 'children less than 2 years of age presenting for medical care with diarrhea in rural Matlab, Bangladesh', 'Diarrheal surveillance collected between 2000 and 2014 within the two service delivery areas (icddr,b service area [ISA] and government service area [GSA]) of the', 'Bangladesh in children <2 years of age']","['programmatic rotavirus vaccination', 'Matlab Health and Demographic Surveillance System administered by icddr', 'rotavirus vaccine introduction', 'Rotarix vaccine (HRV', 'HRV', 'rotavirus vaccines']","['rotavirus-positive (RV+) and rotavirus-negative (RV-) diarrhea', 'RV+ diarrheal incidence', 'RV+ diarrhea incidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}]","[{'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2.0,0.0570139,Significant impact of HRV on RV+ diarrhea incidence in GSA villages was not observed in either model.,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schwartz', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Ahasan-Ul H', 'Initials': 'AH', 'LastName': 'Basunia', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Abu Syed Golam', 'Initials': 'ASG', 'LastName': 'Faruque', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Mustafizur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Sugimoto', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Halloran', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rowhani-Rahbar', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, Washington.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz133']
502,30824830,Audio motor training improves mobility and spatial cognition in visually impaired children.,"Since it has been demonstrated that spatial cognition can be affected in visually impaired children, training strategies that exploit the plasticity of the human brain should be early adopted. Here we developed and tested a new training protocol based on the reinforcement of audio-motor associations and thus supporting spatial development in visually impaired children. The study involved forty-four visually impaired children aged 6-17 years old assigned to an experimental (ABBI training) or a control (classical training) rehabilitation conditions. The experimental training group followed an intensive but entertaining rehabilitation for twelve weeks during which they performed ad-hoc developed audio-spatial exercises with the Audio Bracelet for Blind Interaction (ABBI). A battery of spatial tests administered before and after the training indicated that children significantly improved in almost all the spatial aspects considered, while the control group didn't show any improvement. These results confirm that perceptual development in the case of blindness can be enhanced with naturally associated auditory feedbacks to body movements. Therefore the early introduction of a tailored audio-motor training could potentially prevent spatial developmental delays in visually impaired children.",2019,These results confirm that perceptual development in the case of blindness can be enhanced with naturally associated auditory feedbacks to body movements.,"['forty-four visually impaired children aged 6-17 years old assigned to an', 'visually impaired children']","['Audio motor training', 'experimental (ABBI training) or a control (classical training) rehabilitation conditions', 'intensive but entertaining rehabilitation for twelve weeks during which they performed ad-hoc developed audio-spatial exercises with the Audio Bracelet for Blind Interaction (ABBI']","['spatial developmental delays', 'mobility and spatial cognition']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0424605', 'cui_str': 'Developmental delay (disorder)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",44.0,0.0186937,These results confirm that perceptual development in the case of blindness can be enhanced with naturally associated auditory feedbacks to body movements.,"[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Cappagli', 'Affiliation': 'Unit for Visually Impaired People, Center for Human Technologies, Fondazione Istituto Italiano di Tecnologia, Genova, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Finocchietti', 'Affiliation': 'Unit for Visually Impaired People, Center for Human Technologies, Fondazione Istituto Italiano di Tecnologia, Genova, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cocchi', 'Affiliation': 'Istituto David Chiossone per Ciechi ed ipovedenti ONLUS, Genova, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Giammari', 'Affiliation': 'Centro regionale per l\'ipovisione in età evolutiva, IRCCS Scientific Institute ""E. Medea"", Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Zumiani', 'Affiliation': 'IRIFOR del Trentino, Trento, Italy.'}, {'ForeName': 'Anna Vera', 'Initials': 'AV', 'LastName': 'Cuppone', 'Affiliation': 'Unit for Visually Impaired People, Center for Human Technologies, Fondazione Istituto Italiano di Tecnologia, Genova, Italy.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Baud-Bovy', 'Affiliation': 'RBCS Robotics, Brain and Cognitive Science department, Center for Human Technologies, Fondazione Istituto Italiano di Tecnologia, Genova, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'Unit for Visually Impaired People, Center for Human Technologies, Fondazione Istituto Italiano di Tecnologia, Genova, Italy. monica.gori@iit.it.'}]",Scientific reports,['10.1038/s41598-019-39981-x']
503,30808899,"Neuromuscular magnetic stimulation counteracts muscle decline in ALS patients: results of a randomized, double-blind, controlled study.","The aim of the study was to verify whether neuromuscular magnetic stimulation (NMMS) improves muscle function in spinal-onset amyotrophic lateral sclerosis (ALS) patients. Twenty-two ALS patients were randomized in two groups to receive, daily for two weeks, NMMS in right or left arm (referred to as real-NMMS, rNMMS), and sham NMMS (sNMMS) in the opposite arm. All the patients underwent a median nerve conduction (compound muscle action potential, CMAP) study and a clinical examination that included a handgrip strength test and an evaluation of upper limb muscle strength by means of the Medical Research Council Muscle Scale (MRC). Muscle biopsy was then performed bilaterally on the flexor carpi radialis muscle to monitor morpho-functional parameters and molecular changes. Patients and physicians who performed examinations were blinded to the side of real intervention. The primary outcome was the change in the muscle strength in upper arms. The secondary outcomes were the change from baseline in the CMAP amplitudes, in the nicotinic ACh currents, in the expression levels of a selected panel of genes involved in muscle growth and atrophy, and in histomorphometric parameters of ALS muscle fibers. The Repeated Measures (RM) ANOVA with a Greenhouse-Geisser correction (sphericity not assumed) showed a significant effect [F(3, 63) = 5.907, p < 0.01] of rNMMS on MRC scale at the flexor carpi radialis muscle, thus demonstrating that the rNMMS significantly improves muscle strength in flexor muscles in the forearm. Secondary outcomes showed that the improvement observed in rNMMS-treated muscles was associated to counteracting muscle atrophy, down-modulating the proteolysis, and increasing the efficacy of nicotinic ACh receptors (AChRs). We did not observe any significant difference in pre- and post-stimulation CMAP amplitudes, evoked by median nerve stimulation. This suggests that the improvement in muscle strength observed in the stimulated arm is unlikely related to reinnervation. The real and sham treatments were well tolerated without evident side effects. Although promising, this is a proof of concept study, without an immediate clinical translation, that requires further clinical validation.",2019,"We did not observe any significant difference in pre- and post-stimulation CMAP amplitudes, evoked by median nerve stimulation.","['ALS patients', 'Patients and physicians who performed examinations', 'spinal-onset amyotrophic lateral sclerosis (ALS) patients', 'Twenty-two ALS patients']","['rNMMS', 'Neuromuscular magnetic stimulation', 'neuromuscular magnetic stimulation (NMMS', 'NMMS in right or left arm (referred to as real-NMMS, rNMMS), and sham NMMS (sNMMS']","['muscle strength in flexor muscles', 'efficacy of nicotinic ACh receptors (AChRs', 'change in the muscle strength', 'muscle strength', 'pre- and post-stimulation CMAP amplitudes, evoked by median nerve stimulation', 'MRC scale', 'CMAP amplitudes, in the nicotinic ACh currents, in the expression levels of a selected panel of genes involved in muscle growth and atrophy, and in histomorphometric parameters of ALS muscle fibers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0034792', 'cui_str': 'Receptors, Acetylcholine'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C0222045'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",,0.0534679,"We did not observe any significant difference in pre- and post-stimulation CMAP amplitudes, evoked by median nerve stimulation.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Musarò', 'Affiliation': 'DAHFMO-Unit of Histology and Medical Embryology, Sapienza University of Rome, Laboratory affiliated to Istituto Pasteur Italia - Fondazione Cenci Bolognetti, Rome, 00161, Italy. antonio.musaro@uniroma1.it.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Dobrowolny', 'Affiliation': 'DAHFMO-Unit of Histology and Medical Embryology, Sapienza University of Rome, Laboratory affiliated to Istituto Pasteur Italia - Fondazione Cenci Bolognetti, Rome, 00161, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cambieri', 'Affiliation': 'Rare Neuromuscular Diseases Centre, Department of Human Neuroscience, Sapienza University, Rome, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Onesti', 'Affiliation': 'Rare Neuromuscular Diseases Centre, Department of Human Neuroscience, Sapienza University, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ceccanti', 'Affiliation': 'Rare Neuromuscular Diseases Centre, Department of Human Neuroscience, Sapienza University, Rome, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Frasca', 'Affiliation': 'Rare Neuromuscular Diseases Centre, Department of Human Neuroscience, Sapienza University, Rome, Italy.'}, {'ForeName': 'Annalinda', 'Initials': 'A', 'LastName': 'Pisano', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Cerbelli', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Lepore', 'Affiliation': 'DAHFMO-Unit of Histology and Medical Embryology, Sapienza University of Rome, Laboratory affiliated to Istituto Pasteur Italia - Fondazione Cenci Bolognetti, Rome, 00161, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ruffolo', 'Affiliation': 'Department of Physiology and Pharmacology, Sapienza University of Rome, Laboratory affiliated to Istituto Pasteur Italia-Fondazione Cenci Bolognetti, Rome, 00185, Italy.'}, {'ForeName': 'Pierangelo', 'Initials': 'P', 'LastName': 'Cifelli', 'Affiliation': 'Department of Physiology and Pharmacology, Sapienza Univesrity of Rome, Rome, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Roseti', 'Affiliation': 'IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Giordano', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Sapienza University of Rome, Rome, 00161, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Gori', 'Affiliation': 'Rare Neuromuscular Diseases Centre, Department of Human Neuroscience, Sapienza University, Rome, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Palma', 'Affiliation': 'Department of Physiology and Pharmacology, Sapienza University of Rome, Laboratory affiliated to Istituto Pasteur Italia-Fondazione Cenci Bolognetti, Rome, 00185, Italy. eleonora.palma@uniroma1.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Inghilleri', 'Affiliation': 'Rare Neuromuscular Diseases Centre, Department of Human Neuroscience, Sapienza University, Rome, Italy. maurizio.inghilleri@uniroma1.it.'}]",Scientific reports,['10.1038/s41598-019-39313-z']
504,30770931,"The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants: Substudy of a Cluster-randomized Trial.","BACKGROUND


Oral vaccines have lower efficacy in developing compared to developed countries. Poor water, sanitation, and hygiene (WASH) may contribute to reduced oral vaccine immunogenicity.
METHODS


We conducted a cluster-randomized 2 × 2 factorial trial in rural Zimbabwe. Pregnant women and their infants were eligible if they lived in clusters randomized to (1) standard of care (52 clusters); (2) improved infant feeding (53 clusters); (3) WASH: ventilated improved pit latrine, 2 hand-washing stations, liquid soap, chlorine, infant play space, and hygiene counseling (53 clusters); or (4) feeding plus WASH (53 clusters). This substudy compared oral rotavirus vaccine (RVV) seroconversion (primary outcome), and seropositivity and geometric mean titer (GMT) (secondary outcomes), in WASH vs non-WASH infants by intention-to-treat analysis.
RESULTS


We included 801 infants with documented RVV receipt and postvaccine titer measurements (329 from 84 WASH clusters; 472 from 102 non-WASH clusters); 328 infants with prevaccination titers were included in the primary outcome. Thirty-three of 109 (30.3%) infants in the WASH group seroconverted following rotavirus vaccination, compared to 43 of 219 (19.6%) in the non-WASH group (absolute difference, 10.6% [95% confidence interval {CI}, .54%-20.7%]; P = .031). In the WASH vs non-WASH groups, 90 of 329 (27.4%) vs 107 of 472 (22.7%) were seropositive postvaccination (absolute difference, 4.7% [95% CI, -1.4% to 10.8%]; P = .130), and antirotavirus GMT was 18.4 (95% CI, 15.6-21.7) U/mL vs 14.9 (95% CI, 13.2-16.8) U/mL (P = .072).
CONCLUSIONS


Improvements in household WASH led to modest but significant increases in seroconversion to RVV in rural Zimbabwean infants.
CLINICAL TRIALS REGISTRATION


NCT01824940.",2019,"In the WASH versus non-WASH groups, 90/329 (27.4%) versus 107/472 (22.7%) were seropositive post-vaccination (absolute difference 4.7% (","['rural Zimbabwean infants', 'Pregnant women and their infants were eligible if they lived in clusters randomized to: 1', 'Zimbabwean infants', '801 infants with documented rotavirus vaccine receipt and post-vaccine titre measurements (329 from 84 WASH clusters; 472 from 102 non-WASH clusters); 328 infants with pre-vaccination titres']","['improved water, sanitation and hygiene', 'Standard-of-care (52 clusters); 2) Improved infant feeding (53 clusters); 3) WASH: ventilated improved pit latrine, two hand-washing stations, liquid soap, chlorine, infant play space, hygiene counseling (53 clusters); or 4) Feeding+WASH', 'WASH versus non-WASH', 'rotavirus vaccine', 'WASH']","['oral rotavirus vaccine immunogenicity', 'seropositive post-vaccination', 'seroconversion to oral rotavirus vaccine', 'seroconversion', 'seropositivity and geometric mean titre (GMT', 'Poor water, sanitation and hygiene (WASH']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C3266595', 'cui_str': 'Pit latrine'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}]",801.0,0.419867,"In the WASH versus non-WASH groups, 90/329 (27.4%) versus 107/472 (22.7%) were seropositive post-vaccination (absolute difference 4.7% (","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Church', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rukobo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Govha', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Ohio.""}, {'ForeName': 'Florence D', 'Initials': 'FD', 'LastName': 'Majo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Naume V', 'Initials': 'NV', 'LastName': 'Tavengwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz140']
505,30782546,Correction of the QRS duration for heart rate.,"OBJECTIVE


To determine the clinical value of correcting the QRS duration for heart rate.
BACKGROUND


We recently observed [1] that the QRS duration shortens during spontaneous increases in heart rate. In the current study, we analyzed ECG and pharmacokinetic data of 21 subjects who received quinidine in a recent study [2]. They experienced the expected post-quinidine increase in heart rate, allowing us to determine if quinidine's well-known QRS prolongation might be attenuated due to the concomitant rate increase.
METHODS


In a crossover-designed study, after baseline ECG recording, the subjects received quinidine 400 mg orally or placebo, and ECGs and quinidine plasma concentrations were then obtained at 15 prespecified timepoints over 24 h. The previously determined QRS-RR regression slope (0.0125) [1] was used to rate-correct QRS. Change in QRS from baseline (dQRS) and rate-corrected change in QRS from baseline (dQRSc) over time were plotted with the mean quinidine concentration and the correlation of plasma concentration with dQRS and dQRSc was assessed by pairwise correlation and linear regression.
RESULTS


There was a statistically significantly greater increase in heart rate at all timepoints combined in the quinidine arm compared with the placebo arm (9.9 ± 6.80 vs. 5.2 ± 7.42, respectively, p < 0.0001). dQRSc was significantly greater at all timepoints combined compared with dQRS (1.99 ± 4.824 vs -0.68 ± 4.640 msec, respectively, p < 0.0001). dQRS correlated poorly with quinidine plasma concentration (p = 0.127), with no clear change in QRS observed. On the other hand, dQRSc correlated well with quinidine concentration (p = 0.010), with a clear rise and fall in dQRSc that mirrored the rise and fall of quinidine concentration.
CONCLUSION


Rate correction of the QRS duration improves detection of QRS prolongation in the presence of heart rate change.
CONDENSED ABSTRACT


Using the mean QRS - RR slope determined previously in normal volunteers [1], we corrected the QRS duration for its known dependency on heart rate in 21 subjects who received quinidine and experienced the expected post-quinidine increase in heart rate in a recent clinical trial [2]. We found that uncorrected QRS did not correlate with quinidine concentration (p = 0.127), while rate-corrected QRS correlated well (p = 0.010) and mirrored the rise and fall of quinidine concentration. Rate correction of the QRS duration improves detection of QRS prolongation in the presence of heart rate change.",2019,"There was a statistically significantly greater increase in heart rate at all timepoints combined in the quinidine arm compared with the placebo arm (9.9 ± 6.80 vs. 5.2 ± 7.42, respectively, p < 0.0001).",['21 subjects who received'],"['quinidine 400\u202fmg orally or placebo, and ECGs and quinidine plasma concentrations', 'placebo', 'quinidine']","['rise and fall of quinidine concentration', 'heart rate', 'QRS duration for heart rate', 'quinidine plasma concentration', 'rate-correct QRS', 'quinidine concentration', 'uncorrected QRS', 'dQRSc', 'Change in QRS from baseline (dQRS) and rate-corrected change in QRS', 'rate-corrected QRS', 'plasma concentration with dQRS and dQRSc']",[],"[{'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0615943,"There was a statistically significantly greater increase in heart rate at all timepoints combined in the quinidine arm compared with the placebo arm (9.9 ± 6.80 vs. 5.2 ± 7.42, respectively, p < 0.0001).","[{'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'Mason', 'Affiliation': 'Department of Medicine, Division of Cardiology, University of Utah, Salt Lake City, UT, United States of America. Electronic address: jmason12@charter.net.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Strauss', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States of America.'}, {'ForeName': 'Martino', 'Initials': 'M', 'LastName': 'Vaglio', 'Affiliation': 'AMPS, LLC, New York, NY, United States of America.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Badilini', 'Affiliation': 'AMPS, LLC, New York, NY, United States of America.'}]",Journal of electrocardiology,['10.1016/j.jelectrocard.2019.02.005']
506,30021588,A randomised controlled trial of the clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injections: the hip injection trial (HIT) protocol.,"BACKGROUND


Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection.
METHODS


The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants' 'average' follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial.
DISCUSSION


To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections.
TRIAL REGISTRATION


ISRCTN: 50550256 , 28th July 2015.",2018,"The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study.","['patients with painful hip OA with a linked qualitative study', '204 patients with moderate-to-severe hip OA', 'people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of']","['ultrasound-guided intra-articular corticosteroid and local anaesthetic injections', 'Hip Injection Trial (HIT', 'corticosteroid with 1% lidocaine hydrochloride', 'corticosteroid (triamcinolone acetonide 40\xa0mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone']","['pain intensity', 'patient-reported hip pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551516', 'cui_str': 'Painful hips'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine Hydrochloride'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",204.0,0.131096,"The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study.","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Paskins', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK. z.paskins@keele.ac.uk.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Hughes', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Newcastle-under-Lyme, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Myers', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Newcastle-under-Lyme, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Newcastle-under-Lyme, UK.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Hennings', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Newcastle-under-Lyme, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Newcastle-under-Lyme, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Holden', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Stevenson', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Menon', 'Affiliation': 'Haywood Academic Rheumatology Centre, Midlands Partnership NHS Foundation Trust, Stoke-on-Trent, UK.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Bromley', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Roberts', 'Affiliation': 'University Hospitals North Midlands, Stoke-on-Trent, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Peat', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Jinks', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Oppong', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Roddy', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Staffordshire, ST5 5BG, UK.'}]",BMC musculoskeletal disorders,['10.1186/s12891-018-2153-0']
507,30603800,Effects of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Swallowing Function and Quality of Life of Post-stroke Patients.,"Repetitive transcranial magnetic stimulation (rTMS) is one of the non-invasive techniques, which is used to modulate cortical regions in patients with stroke. The aim of this single blind, controlled study was to investigate the effect of rTMS on swallowing function and quality of life of mono-hemispheric post-stroke patients with dysphagia. Twenty-eight patients were randomized and split between study and control group. Each group received conventional dysphagia rehabilitation 3 days a week for 4 weeks, and study group also received 1 Hz rTMS to unaffected hemisphere in the final week. The descriptive information was noted. The clinical and radiological swallowing evaluation and quality of life assessment have been performed at four different times including before and after the treatment, 1 month and 3 months after the treatment. At baseline, no significant differences were observed between groups in terms of demographic and clinical features (p > 0.05). Swallowing function and quality of life of the patients were statistically improved in both groups towards the third month (p < 0.05). Swallowing function was comparable between two groups. However, a significant improvement was observed on appetite, fear of eating, and mental health parameters of quality of life assessment in the study group compared to the control group (p < 0.05). In conclusion, despite positive changes in some aspects of quality of life, rTMS did not enhance the swallowing function when compared conventional dysphagia rehabilitation. Therefore, the application of 1 Hz rTMS should be reconsidered to improve swallowing function in the chronic period.",2019,"However, a significant improvement was observed on appetite, fear of eating, and mental health parameters of quality of life assessment in the study group compared to the control group (p < 0.05).","['of Post-stroke Patients', 'Twenty-eight patients', 'stroke patients with dysphagia', 'patients with stroke']","['rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation', '1\xa0Hz rTMS', 'conventional dysphagia rehabilitation']","['demographic and clinical features', 'Swallowing Function and Quality of Life', 'swallowing function and quality of life of mono-hemispheric post', 'appetite, fear of eating, and mental health parameters of quality of life assessment', 'Swallowing function and quality of life', 'swallowing function', 'Swallowing function']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0919597', 'cui_str': 'Phagophobia'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",28.0,0.019462,"However, a significant improvement was observed on appetite, fear of eating, and mental health parameters of quality of life assessment in the study group compared to the control group (p < 0.05).","[{'ForeName': 'Nezehat Özgül', 'Initials': 'NÖ', 'LastName': 'Ünlüer', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara Yıldırım Beyazıt University, 06760, Çubuk, Ankara, Turkey. nunluer80@yahoo.com.'}, {'ForeName': 'Çağrı Mesut', 'Initials': 'ÇM', 'LastName': 'Temuçin', 'Affiliation': 'Faculty of Medicine Neurology Department, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Numan', 'Initials': 'N', 'LastName': 'Demir', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Selen', 'Initials': 'S', 'LastName': 'Serel Arslan', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Aynur Ayşe', 'Initials': 'AA', 'LastName': 'Karaduman', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}]",Dysphagia,['10.1007/s00455-018-09965-6']
508,32128877,Efficacy of low-dose versus high-dose simethicone with polyethylene glycol for bowel preparation: A prospective randomized controlled trial.,"BACKGROUND AND AIM


Additional simethicone (SIM) can improve adequate bowel preparation and adenoma detection rate (ADR). However, there is no consensus on the optimal dose of SIM. In this study, we compared the adequate bowel preparation rate with supplementation of split-dose 2 L polyethylene glycol (PEG) with low-dose SIM (200 mg) versus high-dose SIM (1200 mg).
METHODS


This was a prospective, randomized, observer-blinded trial involving consecutive subjects undergoing colonoscopy. The primary outcome was adequate bowel preparation as assessed by Boston Bowel Preparation Scale (BBPS) score.
RESULTS


Four hundred subjects were randomly allocated to low-dose SIM or high-dose SIM group. Baseline characteristics were comparable in the two groups (P > 0.05). No significant between-group differences were observed with respect to total bubble scale (BS) (8.49 ± 1.00 vs 8.39 ± 1.10, P = 0.07), total BBPS score (8.70 ± 0.81 vs 8.29 ± 1.18, P = 0.98), ADR (33.68% vs 31.79%, P = 0.69) or withdrawal time (13 [range, 10-16] min vs 13 [10-15] min, P = 0.96). The intubation time in low-dose SIM group was significantly shorter than that in high-dose SIM group (8 (4-16) min vs 10 [6-17] min, P = 0.04). In addition, BS scores as well as diminutive ADR in right colon were superior in the low-dose SIM group (2.68 ± 0.59 vs 2.52 ± 0.73, P = 0.03 and 54.29% vs 30.30%, P = 0.046, respectively).
CONCLUSION


Addition of low-dose SIM to split-dose 2 L PEG was as effective as addition of high-dose SIM with respect to adequate bowel preparation, ADR and patient tolerance. However, low-dose SIM was superior with respect to intubation time, right colon BS scores, right colon diminutive ADR and cost savings.",2020,"However, low-dose SIM was superior with respect to intubation time, right colon BS scores, right colon diminutive ADR and cost savings.","['Four hundred subjects', 'consecutive subjects undergoing colonoscopy']","['split-dose 2L polyethylene glycol (PEG) with low-dose SIM (200 mg) versus high-dose SIM', 'simethicone (SIM', 'Low- vs. High-Dose Simethicone with Polyethylene Glycol']","['adequate bowel preparation and adenoma detection rate (ADR', 'intubation time, right colon BS scores, right colon diminutive ADR and cost savings', 'total BBPS score', 'diminutive ADR in right colon', 'ADR', 'adequate bowel preparation as assessed by Boston Bowel Preparation Scale (BBPS) score', 'BS scores', 'withdrawal time', 'intubation time', 'total bubble scale (BS']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0037138', 'cui_str': 'Simethicone'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0222045'}]",400.0,0.211159,"However, low-dose SIM was superior with respect to intubation time, right colon BS scores, right colon diminutive ADR and cost savings.","[{'ForeName': 'De-Feng', 'Initials': 'DF', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ming-Han', 'Initials': 'MH', 'LastName': 'Luo', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Qing-Qing', 'Initials': 'QQ', 'LastName': 'Du', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Hai-Yang', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Tian', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Rui-Yue', 'Initials': 'RY', 'LastName': 'Shi', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ming-Guang', 'Initials': 'MG', 'LastName': 'Lai', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ying-Xue', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ben-Hua', 'Initials': 'BH', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Zheng-Lei', 'Initials': 'ZL', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Ding-Guo', 'Initials': 'DG', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}, {'ForeName': 'Li-Sheng', 'Initials': 'LS', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, the Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University, Shenzhen, China.""}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15022']
509,30617738,Effects of growth hormone on hepatic insulin sensitivity and glucose effectiveness in healthy older adults.,"PURPOSE


Growth hormone (GH) replacement decreases insulin sensitivity in healthy individuals. However, the effects of GH on organ-specific insulin sensitivity and glucose effectiveness are not well characterized. The purpose of this study was to evaluate the effects of GH administration for 26 weeks on muscle and hepatic insulin sensitivity and glucose effectiveness in healthy older individuals.
METHODS


This report is from a 26-week randomized, double-blind, placebo-controlled parallel-group trial in healthy, ambulatory, community-dwelling older women and men. We compared surrogate indices of insulin sensitivity [quantitative insulin-sensitivity check index (QUICKI), muscle insulin sensitivity index (MISI), hepatic insulin resistance index (HIRI)] and glucose effectiveness [oral glucose effectiveness index (oGE)] derived from oral glucose tolerance tests (OGTTs) in subjects before and after 26 weeks of administration of GH (n = 17) or placebo (n = 15) as an exploratory outcome.
RESULTS


GH administration for 26 weeks significantly increased fasting insulin concentrations and HIRI but did not significantly change MISI or oGE compared to placebo.
CONCLUSIONS


GH administration for 26 weeks in healthy older subjects impairs insulin sensitivity in the liver but not skeletal muscle and does not alter glucose effectiveness.",2019,"RESULTS


GH administration for 26 weeks significantly increased fasting insulin concentrations and HIRI but did not significantly change MISI or oGE compared to placebo.
","['subjects before and after 26 weeks of administration of GH (n\u2009=\u200917) or', 'healthy, ambulatory, community-dwelling older women and men', 'healthy older adults', 'healthy older subjects', 'healthy individuals', 'healthy older individuals']","['GH', 'growth hormone', 'placebo', 'Growth hormone (GH) replacement']","['muscle and hepatic insulin sensitivity and glucose effectiveness', 'insulin sensitivity', 'fasting insulin concentrations and HIRI', 'insulin sensitivity [quantitative insulin-sensitivity check index (QUICKI), muscle insulin sensitivity index (MISI), hepatic insulin resistance index (HIRI)] and glucose effectiveness [oral glucose effectiveness index (oGE', 'hepatic insulin sensitivity and glucose effectiveness', 'glucose effectiveness', 'organ-specific insulin sensitivity and glucose effectiveness']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.192582,"RESULTS


GH administration for 26 weeks significantly increased fasting insulin concentrations and HIRI but did not significantly change MISI or oGE compared to placebo.
","[{'ForeName': 'Lala', 'Initials': 'L', 'LastName': 'Forrest', 'Affiliation': 'Clinical Endocrine Section, Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sedmak', 'Affiliation': 'Clinical Endocrine Section, Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Shanaz', 'Initials': 'S', 'LastName': 'Sikder', 'Affiliation': 'Clinical Endocrine Section, Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Shivraj', 'Initials': 'S', 'LastName': 'Grewal', 'Affiliation': 'Clinical Endocrine Section, Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'S Mitchell', 'Initials': 'SM', 'LastName': 'Harman', 'Affiliation': 'Endocrinology Section, Department of Medicine, Phoenix VA Health Care System, Phoenix, AZ, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Blackman', 'Affiliation': 'Research Service, Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Ranganath', 'Initials': 'R', 'LastName': 'Muniyappa', 'Affiliation': 'Clinical Endocrine Section, Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA. muniyapr@mail.nih.gov.'}]",Endocrine,['10.1007/s12020-018-01834-4']
510,32143995,Effects of six months of aerobic and resistance training on metabolic markers and bone mineral density in older men on androgen deprivation therapy for prostate cancer.,"BACKGROUND


Androgen deprivation therapy (ADT) for prostate cancer (PCa) is associated with metabolic perturbations and declines in bone mineral density (BMD). Exercise interventions provide multiple health benefits to older men on ADT; however, their effect on metabolic biomarkers and BMD remains unclear.
METHODS


A secondary analysis of a phase II randomized controlled trial was conducted to assess the effect of a six-month moderate-intensity aerobic and resistance exercise program on metabolic biomarkers and BMD in men on ADT. Participants were randomized to three different exercise delivery models: personal training; supervised group exercise; or home-based exercise. Analysis of metabolic biomarkers (lipid profile and glucose) was conducted at baseline, six and twelve months. BMD of the lumbar spine, femoral neck and hip were assessed at baseline and twelve months. Both within- and between-group analyses of change scores adjusted for baseline values were performed.
RESULTS


Forty-eight men (mean age 69.8y) were enrolled. Baseline values of metabolic biomarkers and BMD were comparable between groups and the three groups were combined for the primary analysis. At six months, no changes in metabolic biomarkers were found; however, at twelve months low-density lipoprotein (+0.28 mmol/L; 95%CI, 0.04 to 0.51) and total cholesterol (+0.31 mmol/L; 95%CI, 0.00 to 0.61) were significantly increased from baseline. No changes were found in BMD. In a secondary between-group analysis, no improvements were observed for any metabolic biomarker or BMD measurement.
CONCLUSIONS


Different exercise prescription parameters (modality and intensity) or combined diet/exercise interventions may be needed to foster favorable metabolic and skeletal adaptations during ADT.",2020,No changes were found in BMD.,"['older men on ADT', 'older men on androgen deprivation therapy for prostate cancer', 'men on ADT', 'Forty-eight men (mean age 69.8y) were enrolled', 'prostate cancer (PCa']","['exercise delivery models: personal training; supervised group exercise; or home-based exercise', 'Androgen deprivation therapy (ADT', 'six-month moderate-intensity aerobic and resistance exercise program', 'Exercise interventions', 'Different exercise prescription parameters (modality and intensity) or combined diet/exercise interventions', 'aerobic and resistance training']","['metabolic biomarkers (lipid profile and glucose', 'BMD of the lumbar spine, femoral neck and hip', 'BMD', 'metabolic biomarkers', 'Baseline values of metabolic biomarkers and BMD', 'total cholesterol', 'metabolic biomarkers and BMD', 'bone mineral density (BMD', 'metabolic biomarker or BMD measurement', 'metabolic markers and bone mineral density']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",48.0,0.07774,No changes were found in BMD.,"[{'ForeName': 'Efthymios', 'Initials': 'E', 'LastName': 'Papadopoulos', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada; Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada. Electronic address: efthymios.papadopoulos@mail.utoronto.ca.'}, {'ForeName': 'Daniel Santa', 'Initials': 'DS', 'LastName': 'Mina', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada; Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Durbano', 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Krahn', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada; Toronto General Hospital Research Institute, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada; Toronto General Hospital Research Institute, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Narhari', 'Initials': 'N', 'LastName': 'Timilshina', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Matthew', 'Affiliation': 'Cancer Clinical Research Unit, University Health Network, Toronto, ON M5G 2C1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': 'Warde', 'Affiliation': 'Cancer Clinical Research Unit, University Health Network, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Shabbir M H', 'Initials': 'SMH', 'LastName': 'Alibhai', 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2020.02.013']
511,31148210,Rationale for and Design of the Study of Early Enteral Dextrose in Sepsis: A Pilot Placebo-Controlled Randomized Clinical Trial.,"BACKGROUND


Sepsis is characterized by life-threatening organ dysfunction caused by a dysregulated host response to infection and affects over 1 million Americans annually. Loss of glycemic control in sepsis is associated with increased morbidity and mortality, and novel approaches are needed to promote euglycemia and improve outcomes in sepsis. Recent studies from our laboratory demonstrate that early low-level enteral dextrose infusion in septic mice attenuates the systemic inflammatory response and improves glycemic control by inducing intestine-derived incretin hormone secretion.
AIM


The aim of the Study of Early Enteral Dextrose in Sepsis (SEEDS) is to test the effect of a 24-hour enteral dextrose infusion in critically ill septic patients as a therapeutic agent to decrease systemic inflammation and promote euglycemia.
METHODS


SEEDS is a single-center, double-blind, randomized, controlled trial that will enroll 60 septic patients admitted to the intensive care units at the University of Pittsburgh Medical Center Health System in Pittsburgh. Participants will be randomized 1:1 to receive enteral dextrose (n = 30) or water (placebo, n = 30) infusion for 24 hours. The primary outcome is the circulating interleukin-6 level measured after the 24-hour infusion compared between dextrose and placebo groups. Secondary outcomes include postinfusion circulating insulin, incretin, and other proinflammatory cytokine levels, as well as incidence of hyperglycemia and hypoglycemia during the infusion period.
DISCUSSION


This trial will characterize the effects of early enteral dextrose on endogenous endocrine pathways and the systemic inflammatory response in sepsis. The results of this trial will inform future larger interventional studies of early enteral nutrients in critically ill patients with sepsis.",2020,The primary outcome is the circulating interleukin-6 level measured after the 24-hour infusion compared between dextrose and placebo groups.,"['critically ill patients with sepsis', 'critically ill septic patients', 'Sepsis', 'sepsis', '60 septic patients admitted to the intensive care units at the University of Pittsburgh Medical Center Health System in Pittsburgh']","['enteral dextrose', 'Placebo', 'placebo', 'enteral dextrose (n\xa0=\xa030) or water (placebo, n\xa0=\xa030) infusion for 24 hours']","['circulating interleukin-6 level', 'postinfusion circulating insulin, incretin, and other proinflammatory cytokine levels, as well as incidence of hyperglycemia and hypoglycemia during the infusion period']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]",60.0,0.668736,The primary outcome is the circulating interleukin-6 level measured after the 24-hour infusion compared between dextrose and placebo groups.,"[{'ForeName': 'Faraaz Ali', 'Initials': 'FA', 'LastName': 'Shah', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Georgios D', 'Initials': 'GD', 'LastName': 'Kitsios', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Yingze', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Yende', 'Affiliation': 'Veteran Affairs, Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': ""O'Donnell"", 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'McVerry', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1608']
512,31831384,Contributions of Early Care and Education Programs to Diet Quality in Children Aged 3 to 4 Years in Central North Carolina.,"BACKGROUND


Parents and early care and education (ECE) are the key influencers of young children's diets, but there is limited information about how each contribute to children's overall diet quality.
OBJECTIVE


This study aimed to determine what proportion of children's dietary intake occurs within the ECE setting and whether diet quality is higher at ECE centers and, consequently, on weekdays than weekends.
DESIGN


This cross-sectional analysis of a larger cluster randomized controlled trial used multiple 24-hour dietary intakes measured through a combination of the Dietary Observation in Child Care protocol and parent-reported food diaries.
PARTICIPANTS/SETTING


Participants (N=840) included children aged 3 to 4 years enrolled in ECE centers in central North Carolina for whom 24-hour dietary intake was captured via observation of meals and snacks consumed at ECE and parent-report of all remaining meals and snacks. Data were collected from 2015 to 2016.
MAIN OUTCOME MEASURES


Diet quality at ECE and elsewhere was evaluated using the Healthy Eating Index 2015.
STATISTICAL ANALYSES PERFORMED


Mixed-effects models were used to determine differences in mean Healthy Eating Index 2015 component and total scores. Models were adjusted for children's age and sex and accounted for clustering within ECE centers and families.
RESULTS


Children consumed approximately 40% of daily energy, nutrients, and food groups at ECE centers. The mean total Healthy Eating Index 2015 score was higher for foods and beverages consumed at ECE centers (58.3±0.6) than elsewhere (52.5±0.6) (P<0.0001). The mean total Healthy Eating Index 2015 score was also higher on weekdays (58.5±0.5) than on weekends (51.3±0.5) (P<0.0001).
CONCLUSIONS


Children consume a majority of dietary intake away from ECE centers. Overall, diet quality is low, but the quality of foods consumed by children at ECE centers is higher than that consumed elsewhere. ECE centers remain an important source of nutrition and further investigation is warranted to identify ways to support both ECE centers and families to provide healthier eating environments.",2020,"The mean total Healthy Eating Index 2015 score was also higher on weekdays (58.5±0.5) than on weekends (51.3±0.5) (P<0.0001).
","['Participants (N=840) included children aged 3 to 4 years enrolled in ECE centers in central North Carolina for whom 24-hour dietary intake was captured via observation of meals and snacks consumed at ECE and parent-report of all remaining meals and snacks', 'Children Aged 3 to 4 Years in Central North Carolina']",[],"['mean total Healthy Eating Index 2015 score', 'mean Healthy Eating Index 2015 component and total scores', 'Diet quality at ECE and elsewhere was evaluated using the Healthy Eating Index\xa02015']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.110915,"The mean total Healthy Eating Index 2015 score was also higher on weekdays (58.5±0.5) than on weekends (51.3±0.5) (P<0.0001).
","[{'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Luecking', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mazzucca', 'Affiliation': ''}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': ''}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.09.018']
513,29928699,"Methodology for tissue sample collection within a translational sub-study of the CHHiP trial (CRUK/06/016), a large randomised phase III trial in localised prostate cancer.","Background


This article presents the methodology for tissue sample collection in Trans-CHHiP, the main translational study within the CHHiP (Conventional or Hypofractionated High dose intensity modulated radiotherapy in Prostate cancer, ISRCTN 97182923) trial. The CHHiP trial randomised 3216 men with localised prostate cancer to 3 different radiotherapy fractionation schedules. Trans-CHHiP aims to identify biomarkers of fraction sensitivity.
Methods


We outline the process of tissue collection, including central review by a study-specific specialist uropathologist and comparison of the centrally-assigned Gleason grade group with that assigned by the recruiting-centre pathologist.
Results


2047 patients provided tissue from 107 pathology departments between August 2012 and April 2014. A highly motivated Clinical Trials Unit chasing samples and a central Trans-CHHiP group that regularly reviewed progress were important for successful sample collection. Agreement in Gleason grade group assigned by the recruiting centre pathologist and the central study-specific uropathologist occurred in 886 out of 1854 (47.8%) cases. Key lessons learned were the need for prospective consent for tissue collection when recruiting patients to the main trial, and the importance of Material Transfer Agreement (MTA) integration into the initial trial site agreement.
Conclusions


This methodology enabled collection of 2047 patient samples from a large randomised radiotherapy trial. Central pathological review is important to minimise subjectivity in Gleason grade grouping and the impact of grade shift.",2018,The CHHiP trial randomised 3216 men with localised prostate cancer to 3 different radiotherapy fractionation schedules.,"['3216 men with localised prostate cancer to 3 different radiotherapy fractionation schedules', '2047 patient samples from a large randomised radiotherapy trial', 'localised prostate cancer', '2047 patients provided tissue from 107 pathology departments between August 2012 and April 2014']",['CHHiP (Conventional or Hypofractionated High'],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0587487', 'cui_str': 'Pathology department (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",[],3216.0,0.17254,The CHHiP trial randomised 3216 men with localised prostate cancer to 3 different radiotherapy fractionation schedules.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilkins', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Stuttle', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Blanchard', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cruickshank', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Probert', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Corbishley', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden Hospital, Downs Road, Sutton SM2 5PT, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dearnaley', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research, 123 Old Brompton Road, London SW7 3RP, United Kingdom.'}]",Clinical and translational radiation oncology,['10.1016/j.ctro.2018.02.002']
514,30509224,Can professional football clubs deliver a weight management programme for women: a feasibility study.,"BACKGROUND


Levels of obesity remain high in the UK. The Football Fans in Training (FFIT) randomised controlled trial (RCT) demonstrated that a 12-week, gender-sensitised weight management, physical activity and healthy eating group programme delivered through professional football clubs helped men aged 35-65 years with BMI at least 28 kg/m 2  lose a clinically-significant amount of weight. We aimed to test the feasibility of a minimally-adapted FFIT programme for delivery to women by assessing recruitment and completion rates; determining if the programme content and delivery required further refinement; and evaluating the potential of FFIT for Women to deliver improvements in weight and other clinical, behavioural and psychological outcomes.
METHODS


A feasibility study of the FFIT for Women programme including before-and-after measurements of clinical (weight, waist, body mass index [BMI], blood pressure) behavioural (self-reported physical activity, food and alcohol intake) and psychological (self-esteem, positive and negative affect, physical and mental HRQoL) outcomes at five professional football clubs. Post-programme focus groups assessed acceptability of the programme format, content and style of delivery for women.
RESULTS


Recruitment across the five clubs resulted in 123 women aged 35-65 years with BMI at least 28 kg/m 2  taking part in the study. The mean weight (95.3 kg) and BMI (36.6 kg/m2) of the cohort were both suggestive of high risk of future disease. Of 123 women who started the programme, 94 (76%) completed it; 72 (58.5%) returned for 12-week follow-up measurements. Participants compared FFIT for Women favourably to commercial weight loss programmes and emphasised the importance of the programme's physical activity content. They also spoke positively about group dynamics, suggested that the approach to food was less restrictive than in other weight loss approaches, and broadly enjoyed the football setting. Mean weight loss was 2.87 kg (95% CI 2.09, 3.65, p ≤ 0.001). Mean waist reduction was 3.84 cm (2.92, 4.77, p ≤ 0.001).
CONCLUSION


In this evaluation, FFIT for Women was feasible, acceptable and demonstrated potential as a weight loss programme. Our findings suggest the programme has the potential to produce outcomes that are on a par with existing commercial and state-funded offerings.",2018,"Mean waist reduction was 3.84 cm (2.92, 4.77, p ≤ 0.001).
","['123 women aged 35-65\u2009years with BMI at least 28\u2009kg/m 2  taking part in the study', '123 women who started the programme, 94 (76%) completed it; 72 (58.5%) returned for 12-week follow-up measurements', 'women']","['minimally-adapted FFIT programme', 'FFIT', 'physical activity and healthy eating group programme delivered through professional football clubs']","['Mean waist reduction', 'mean weight', 'acceptability of the programme format, content and style of delivery for women', 'Mean weight loss', 'clinical (weight, waist, body mass index [BMI], blood pressure) behavioural (self-reported physical activity, food and alcohol intake) and psychological (self-esteem, positive and negative affect, physical and mental HRQoL) outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",123.0,0.0792067,"Mean waist reduction was 3.84 cm (2.92, 4.77, p ≤ 0.001).
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bunn', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Science, University of Glasgow, Glasgow, UK. christopher.bunn@glasgow.ac.uk.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Donnachie', 'Affiliation': 'Social and Public Health Sciences Unit, Medical Research Council/Chief Scientist Office, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Brennan', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Lennox', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Maclean', 'Affiliation': 'Social and Public Health Sciences Unit, Medical Research Council/Chief Scientist Office, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Science, University of Glasgow, Glasgow, UK.'}]",BMC public health,['10.1186/s12889-018-6255-2']
515,30209561,Tongue-Strengthening Exercises in Healthy Older Adults: Does Exercise Load Matter? A Randomized Controlled Trial.,"Tongue-strengthening exercises (TSE) are based on the principles of exercise and motor learning, including intensity. Intensity is manipulated by gradually adjusting the resistive load. This randomized controlled trial (RCT) investigates the effect of three different values resistive load during TSE in healthy older adults. Sixty subjects completed 8 weeks of TSE while exercising with Iowa Oral Performance Instrument (IOPI). They were randomly distributed to 4 different treatment arms: 3 exercise groups (EG1: n = 15; EG2: n = 16, EG3: n = 16) and 1 control group performing lip-strengthening exercises (CG: n = 13). Values of resistive load for EG1, EG2, and EG3 were 100, 80, and 60% 1RM, respectively. Anterior and posterior maximal isometric pressures (MIP A , MIP P ) were measured at baseline, after 4 and 8 weeks of training and 4 weeks post-training. MIP A  and MIP P  in the EG were significantly higher than in the CG at all time points, except baseline. No significant differences between EG were found, but some trends were observable. Anteriorly, the higher the resistive load, the higher the increase in MIP. Posteriorly, 100% 1RM caused the highest values, followed by 60% and 80% 1RM. No detraining effects were measured. The degree of exercise load had a significant negative effect on the registered success rate. This RCT confirms the efficacy of TSE in healthy older adults. For MIP A  and MIP P , TSE at a resistive load of 100% 1RM are the most efficient choice in this population, while lowering the resistive load will lead to an increased success rate. No detraining effects were registered.",2019,"MIP A  and MIP P  in the EG were significantly higher than in the CG at all time points, except baseline.","['Healthy Older Adults', 'Sixty subjects completed 8\xa0weeks of TSE while exercising with Iowa Oral Performance Instrument (IOPI', 'healthy older adults']","['TSE', 'Tongue-strengthening exercises (TSE', '3 exercise groups (EG1: n\u2009=\u200915; EG2: n\u2009=\u200916, EG3: n\u2009=\u200916) and 1 control group performing lip-strengthening exercises (CG: n\u2009=\u200913', 'Tongue-Strengthening Exercises']","['MIP A  and MIP P', 'MIP', 'Values of resistive load for EG1, EG2, and EG3', 'Anterior and posterior maximal isometric pressures (MIP A , MIP P ']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",,0.0658367,"MIP A  and MIP P  in the EG were significantly higher than in the CG at all time points, except baseline.","[{'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Van den Steen', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium. Leen.Van.den.Steen@uza.be.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vanderwegen', 'Affiliation': 'Department of Speech, Language and Audiology, University College Thomas More, Molenstraat 8, 2018, Antwerp, Belgium.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Guns', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Elen', 'Affiliation': 'Department of Speech, Language and Audiology, University College Thomas More, Molenstraat 8, 2018, Antwerp, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Bodt', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Van Nuffelen', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}]",Dysphagia,['10.1007/s00455-018-9940-5']
516,31918984,High-intensity interval exercise and hypoglycaemia minimisation in adults with type 1 diabetes: A randomised cross-over trial.,"AIMS


We aimed to examine the feasibility and safety of undertaking high-intensity interval exercise (HIIE) with evening basal insulin dose reduction on exercise-related hypoglycaemia following an afternoon bout of HIIE, compared with moderate-intensity continuous exercise and a non-exercise control day in adults with type 1 diabetes in a free-living environment.
METHODS


Twelve adults with type 1 diabetes participated in a randomised, crossover trial (9 female/3 male, mean age 40.4 ± 9.9 years, duration 16.5 ± 9.8 years, HbA1c 8.0 ± 0.8%). Each participant undertook five conditions: a non-exercise day, and four exercise conditions on separate afternoons: a moderate-intensity continuous exercise bout; and three HIIE bouts with 10%, 20% and 30% evening basal insulin reduction. Post-exercise glucose response was measured for 24 h by continuous glucose monitoring and compared across conditions.
RESULTS


HIIE with 10%, 20% and 30% evening basal insulin dose reduction was not associated with an increase in hypoglycaemia compared with moderate-intensity continuous exercise, or the non-exercise day. There was no difference in hyperglycaemia, time-in-range or glucose variability across all exercise regimens and the non-exercise day (p > .05).
CONCLUSIONS


Exercise-related hypoglycaemia was not increased following afternoon HIIE when diabetes management strategies incorporating evening basal insulin dose reduction were utilised.",2020,"There was no difference in hyperglycaemia, time-in-range or glucose variability across all exercise regimens and the non-exercise day (p > .05).
","['adults with type 1 diabetes in a free-living environment', 'adults with type 1 diabetes', 'Twelve adults with type 1 diabetes participated in a randomised, crossover trial (9 female/3 male, mean age 40.4\u202f±\u202f9.9\u202fyears, duration 16.5\u202f±\u202f9.8\u202fyears, HbA1c 8.0\u202f±\u202f0.8']","['moderate-intensity continuous exercise and a non-exercise control day', 'non-exercise day, and four exercise conditions on separate afternoons: a moderate-intensity continuous exercise bout', 'High-intensity interval exercise and hypoglycaemia minimisation', 'undertaking high-intensity interval exercise (HIIE) with evening basal insulin']","['hyperglycaemia, time-in-range or glucose variability', 'Post-exercise glucose response', 'hypoglycaemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",12.0,0.0988237,"There was no difference in hyperglycaemia, time-in-range or glucose variability across all exercise regimens and the non-exercise day (p > .05).
","[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia; Sydney Medical School, Faculty of Medicine and Health, Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kimberley L', 'Initials': 'KL', 'LastName': 'Way', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; The Boden Collaboration, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; The Boden Collaboration, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia; Sydney Medical School, Faculty of Medicine and Health, Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: stephen.twigg@sydney.edu.au.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.107514']
517,30026614,Feasibility and acceptability of brief behavioral therapy for cancer-related insomnia: effects on insomnia and circadian rhythm during chemotherapy: a phase II randomised multicentre controlled trial.,"BACKGROUND


This phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia (BBT-CI) in breast cancer patients undergoing chemotherapy. We also assessed the preliminary effects of BBT-CI on insomnia and circadian rhythm in comparison to a Healthy Eating Education Learning control condition (HEAL).
METHODS


Of the 71 participants recruited, 34 were randomised to receive BBT-CI and 37 to receive HEAL. Oncology staff was trained to deliver the intervention in four community clinics affiliated with the NCI. Insomnia was assessed with the Insomnia Severity Index (ISI), and circadian rhythm was assessed using a wrist-worn actiwatch.
RESULTS


Community staff interveners delivered 72% of the intervention components, with a recruitment rate of 77% and an adherence rate of 73%, meeting acceptability and feasibility benchmarks. Those randomised to BBT-CI improved their ISI scores by 6.3 points compared to a 2.5-point improvement in those randomised to HEAL (P = 0.041). Actigraphy data indicated that circadian functioning improved in the BBT-CI arm as compared to the HEAL arm at post-intervention (all P-values <0.05).
CONCLUSIONS


BBT-CI is an acceptable and feasible intervention that can be delivered directly in the community oncology setting by trained staff. The BBT-CI arm experienced significant improvements in insomnia and circadian rhythm as compared to the control condition.",2018,"Actigraphy data indicated that circadian functioning improved in the BBT-CI arm as compared to the HEAL arm at post-intervention (all P-values <0.05).
","['cancer-related insomnia', 'four community clinics affiliated with the NCI', 'Of the 71 participants recruited', 'Healthy Eating Education Learning control condition (HEAL', 'breast cancer patients undergoing chemotherapy']","['behavioral therapy', 'BBT-CI and 37 to receive HEAL', 'chemotherapy', 'BBT-CI']","['meeting acceptability and feasibility benchmarks', 'circadian functioning', 'insomnia and circadian rhythm', 'Insomnia Severity Index (ISI), and circadian rhythm', 'adherence rate', 'ISI scores', 'Insomnia']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0547820', 'cui_str': 'Healthy eating education (procedure)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",71.0,0.138112,"Actigraphy data indicated that circadian functioning improved in the BBT-CI arm as compared to the HEAL arm at post-intervention (all P-values <0.05).
","[{'ForeName': 'Oxana', 'Initials': 'O', 'LastName': 'Palesh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. opalesh@stanford.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Scheiber', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Guido', 'Affiliation': 'University of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Heckler', 'Affiliation': 'University of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.'}, {'ForeName': 'Mallory G', 'Initials': 'MG', 'LastName': 'Cases', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Metro-Minnesota Community Oncology Research Consortium, Minneapolis, MN, USA.'}, {'ForeName': 'Nick G', 'Initials': 'NG', 'LastName': 'Chrysson', 'Affiliation': 'Novant Health Oncology Specialists, Winston-Salem, NC, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Mustian', 'Affiliation': 'University of Rochester Medical Center, James P. Wilmot Cancer Institute, Rochester, NY, USA.'}]",British journal of cancer,['10.1038/s41416-018-0154-2']
518,31977640,Pectin-Alginate Does Not Further Enhance Exogenous Carbohydrate Oxidation in Running.,"PURPOSE


Maximizing carbohydrate availability is important for many endurance events. Combining pectin and sodium alginate with ingested maltodextrin-fructose (MAL + FRU + PEC + ALG) has been suggested to enhance carbohydrate delivery via hydrogel formation, but the influence on exogenous carbohydrate oxidation remains unknown. The primary aim of this study was to assess the effects of MAL + FRU + PEC + ALG on exogenous carbohydrate oxidation during exercise compared with a maltodextrin-fructose mixture (MAL + FRU). MAL + FRU has been well established to increase exogenous carbohydrate oxidation during cycling compared with glucose-based carbohydrates (MAL + GLU). However, much evidence focuses on cycling, and direct evidence in running is lacking. Therefore, a secondary aim was to compare exogenous carbohydrate oxidation rates with MAL + FRU versus MAL + GLU during running.
METHODS


Nine trained runners completed two trials (MAL + FRU and MAL + FRU + PEC + ALG) in a double-blind, randomized crossover design. A subset (n = 7) also completed a MAL + GLU trial to address the secondary aim, and a water trial to establish background expired CO2 enrichment. Participants ran at 60% V˙O2peak for 120 min while ingesting either water only or carbohydrate solutions at a rate of 1.5 g carbohydrate per minute.
RESULTS


At the end of 120 min of exercise, exogenous carbohydrate oxidation rates were 0.9 (SD 0.5) g·min with MAL + GLU ingestion. MAL + FRU ingestion increased exogenous carbohydrate oxidation rates to 1.1 (SD 0.3) g·min (P = 0.038), with no further increase with MAL + FRU + PEC + ALG ingestion (1.1 (SD 0.3) g·min; P = 1.0). No time-treatment interaction effects were observed for plasma glucose, lactate, insulin, or nonesterified fatty acids, or for ratings of perceived exertion or gastrointestinal symptoms (all, P > 0.05).
CONCLUSION


To maximize exogenous carbohydrate oxidation during moderate-intensity running, athletes may benefit from consuming glucose(polymer)-fructose mixtures over glucose-based carbohydrates alone, but the addition of pectin and sodium alginate offers no further benefit.",2020,"No time x treatment interaction effects were observed for plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms (all p>0.05).
",['Nine trained runners completed two trials'],"['Pectin-Alginate', 'maltodextrin-fructose mixture (MAL+FRU', 'MAL+FRU versus MAL+GLU', 'MAL+FRU+PEC+ALG', 'MAL+FRU', 'pectin and sodium alginate with ingested maltodextrin-fructose (MAL+FRU+PEC+ALG', 'MAL+FRU ingestion', 'MAL+FRU and MAL+FRU+PEC+ALG']","['Exogenous Carbohydrate Oxidation', 'exogenous carbohydrate oxidation rates', 'exogenous carbohydrate oxidation', 'plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0070203', 'cui_str': 'pectin'}, {'cui': 'C0102137', 'cui_str': 'alginate'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",,0.0628111,"No time x treatment interaction effects were observed for plasma glucose, lactate, insulin or non-esterified fatty acids, nor for ratings of perceived exertion or gastrointestinal symptoms (all p>0.05).
","[{'ForeName': 'James F P', 'Initials': 'JFP', 'LastName': 'Barber', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Narang', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UNITED KINGDOM.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002262']
519,28884306,Probiotic Soy Milk Consumption and Renal Function Among Type 2 Diabetic Patients with Nephropathy: a Randomized Controlled Clinical Trial.,"Diabetic nephropathy (DN) is one the most important complications of diabetes leading to end-stage renal disease. Dietary approaches have been considered to control of the kidney function deterioration among these patients. The aim of the present study was to determine the effects of fortified soy milk with Lactobacillus plantarum A7 on renal function biomarkers in type 2 DN patients. Forty-eight DN subjects were attended to this parallel randomized trial study. Participants were randomly assigned to consume a diet containing 200 mL/day probiotic soy milk in intervention group or soy milk in the control condition for 8 weeks. An inflammatory adipokine-Progranulin (PGRN), a cytokine receptor-soluble tumor necrosis factor receptor 1 (sTNFR1), and serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C (Cys-C) as the new renal function biomarkers were measured after 8 weeks of intervention according to the standard protocol. Our analysis showed that consumption of probiotic soy milk resulted in a significant reduction in the Cys-C and PGRN levels compared with the soy milk (P = 0.01) in the final adjusted model. In addition, after adjustment for age, weight, and energy intake, a marginally significant in the NGAL level was seen between two groups (P = 0.05). However, there was no significant differences on the sTNFR1concenteration between two groups (P = 0.06). Overall, intake of probiotic soy milk may have a beneficial effect on the renal function in patients with DN.",2019,Our analysis showed that consumption of probiotic soy milk resulted in a significant reduction in the Cys-C and PGRN levels compared with the soy milk (P = 0.01) in the final adjusted model.,"['type 2 DN patients', 'Diabetic nephropathy (DN', 'Type 2 Diabetic Patients with Nephropathy', 'Forty-eight DN subjects', 'patients with DN']","['fortified soy milk with Lactobacillus plantarum A7', 'Probiotic Soy Milk Consumption and Renal Function', 'diet containing 200\xa0mL/day probiotic soy milk in intervention group or soy milk']","['renal function biomarkers', 'NGAL level', 'Cys-C and PGRN levels', 'sTNFR1concenteration', 'renal function']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0452741', 'cui_str': 'Soy Milk'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439446', 'cui_str': 'mL/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0201343,Our analysis showed that consumption of probiotic soy milk resulted in a significant reduction in the Cys-C and PGRN levels compared with the soy milk (P = 0.01) in the final adjusted model.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Miraghajani', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Zaghian', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Dehkohneh', 'Affiliation': 'Department of Biotechnology, Faculty of Advanced Sciences & Technology, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirlohi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghiasvand', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. ghiasvand@hlth.mui.ac.ir.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-017-9325-3']
520,31982882,Feasibility of Online Haemodiafiltration in Sleep Apnoea: A Randomized Crossover Study.,"BACKGROUND


Sleep apnoea is prevalent in dialysis patients. Previous studies identified excessive inflammation in -patients with sleep apnoea. Online haemodiafiltration -(OL-HDF) may reduce systematic inflammation through better clearance of middle molecules. We aimed to determine the feasibility of OL-HDF in sleep apnoea management.
METHODS


Eligible dialysis patients were screened for risk of sleep apnoea by nocturnal oximetry followed by a diagnostic sleep study to assess apnoea-hypopnea index (AHI). Patients with AHI ≥15/h were invited to a randomized crossover trial. The intervention was 2-month high-flux haemodialysis (HF-HD) followed by 2-month OL-HDF or vice versa with 1-month washout via HF-HD. Feasibility was assessed by patient recruitment and the primary outcome, severity of sleep apnoea (AHI). Secondary outcomes were pro-inflammatory cytokines, patient-reported daytime sleepiness, quality of sleep and health-related quality of life.
RESULTS


Of 65 participants at risk of sleep apnoea, only 15 were consented and randomized (mean age 70 years, 80% male, mean AHI 42.2/h). AHI was not statistically different between OL-HDF versus HF-HD (55.6/h vs. 48.3/h, p = 0.134); however, when sleep apnoea was stratified into obstructive and central apnoea, patients had less obstructive episodes after treated by OL-HDF (23.2/h vs. 18.6/h, p = 0.178); a sensitivity analysis was performed excluding outliers, and the treatment effect for obstructive episodes was found to be statistically significant (11.1 vs. 18.2/h, p = 0.019). Pro-inflammatory biomarkers and patient-reported outcomes were similar between OL-HDF and HF-HD.
CONCLUSION


Patient recruitment was a major challenge in this feasibility study. OL-HDF may reduce obstructive sleep apnoea; however, the result needs to be confirmed by larger studies.",2020,"AHI was not statistically different between OL-HDF versus HF-HD (55.6/h vs. 48.3/h, p = 0.134); however, when sleep apnoea was stratified into obstructive and central apnoea, patients had less obstructive episodes after treated by OL-HDF (23.2/h vs. 18.6/h, p = 0.178); a sensitivity analysis was performed excluding outliers, and the treatment effect for obstructive episodes was found to be statistically significant (11.1 vs. 18.2/h, p = 0.019).","['Patients with AHI ≥15/h', '65 participants at risk of sleep apnoea, only 15 were consented and randomized (mean age 70 years, 80% male', 'dialysis patients', 'patients with sleep apnoea', 'Sleep Apnoea', 'Eligible dialysis patients were screened for risk of sleep apnoea by nocturnal oximetry followed by a diagnostic sleep study to assess']","['Online Haemodiafiltration', 'OL-HDF']","['apnoea-hypopnea index (AHI', 'obstructive episodes', 'sleep apnoea', 'pro-inflammatory cytokines, patient-reported daytime sleepiness, quality of sleep and health-related quality of life', 'AHI', 'obstructive sleep apnoea', 'severity of sleep apnoea (AHI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0520073,"AHI was not statistically different between OL-HDF versus HF-HD (55.6/h vs. 48.3/h, p = 0.134); however, when sleep apnoea was stratified into obstructive and central apnoea, patients had less obstructive episodes after treated by OL-HDF (23.2/h vs. 18.6/h, p = 0.178); a sensitivity analysis was performed excluding outliers, and the treatment effect for obstructive episodes was found to be statistically significant (11.1 vs. 18.2/h, p = 0.019).","[{'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Chu', 'Affiliation': 'Department of Nephrology, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, Charlestown, New South Wales, Australia, ginger.chu@health.nsw.gov.au.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Suthers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Gemma M', 'Initials': 'GM', 'LastName': 'Paech', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Eyeington', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, Charlestown, New South Wales, Australia.'}, {'ForeName': 'Lakshitha', 'Initials': 'L', 'LastName': 'Gunawardhana', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Kerrin', 'Initials': 'K', 'LastName': 'Palazzi', 'Affiliation': 'Hunter Medical Research Institute, CReDITSS, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McDonald', 'Affiliation': 'School of Nursing and Midwifery, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Choi', 'Affiliation': 'Department of Nephrology, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, Charlestown, New South Wales, Australia.'}]",Blood purification,['10.1159/000505572']
521,31975494,Biventricular pacemaker therapy improves exercise capacity in patients with non-obstructive hypertrophic cardiomyopathy via augmented diastolic filling on exercise.,"AIMS


Treatment options for patients with non-obstructive hypertrophic cardiomyopathy (HCM) are limited. We sought to determine whether biventricular (BiV) pacing improves exercise capacity in HCM patients, and whether this is via augmented diastolic filling.
METHODS AND RESULTS


Thirty-one patients with symptomatic non-obstructive HCM were enrolled. Following device implantation, patients underwent detailed assessment of exercise diastolic filling using radionuclide ventriculography in BiV and sham pacing modes. Patients then entered an 8-month crossover study of BiV and sham pacing in random order, to assess the effect on exercise capacity [peak oxygen consumption (VO 2  )]. Patients were grouped on pre-specified analysis according to whether left ventricular end-diastolic volume increased (+LVEDV) or was unchanged/decreased (-LVEDV) with exercise at baseline. Twenty-nine patients (20 male, mean age 55 years) completed the study. There were 14 +LVEDV patients and 15 -LVEDV patients. Baseline peak VO 2  was lower in -LVEDV patients vs. +LVEDV patients (16.2 ± 0.9 vs. 19.9 ± 1.1 mL/kg/min, P = 0.04). BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients. Left ventricular ejection fraction and end-systolic elastance did not increase with BiV pacing in either group. This translated into significantly greater improvements in exercise capacity (peak VO 2   + 1.4 mL/kg/min, P = 0.03) and quality of life scores (P = 0.02) in -LVEDV patients during the crossover study. There was no effect on left ventricular mechanical dyssynchrony in either group.
CONCLUSION


Symptomatic patients with non-obstructive HCM may benefit from BiV pacing via augmentation of diastolic filling on exercise rather than contractile improvement. This may be due to relief of diastolic ventricular interaction.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT00504647.",2020,"BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients.","['patients with non-obstructive hypertrophic cardiomyopathy via augmented diastolic filling on exercise', 'patients with non-obstructive hypertrophic cardiomyopathy (HCM', 'Symptomatic patients with non-obstructive HCM', 'HCM patients', 'Thirty-one patients with symptomatic non-obstructive HCM were enrolled', 'Twenty-nine patients (20 male, mean age 55\u2009years) completed the study']","['biventricular (BiV) pacing', 'Biventricular pacemaker therapy', 'exercise diastolic filling using radionuclide ventriculography in BiV and sham pacing modes', 'BiV and sham pacing']","['Left ventricular ejection fraction and end-systolic elastance', 'Baseline peak VO 2', 'exercise capacity [peak oxygen consumption (VO 2  ', 'exercise capacity', 'BiV pacing', 'left ventricular mechanical dyssynchrony', 'Δstroke volume', 'quality of life scores', 'left ventricular end-diastolic volume increased (+LVEDV', 'exercise ΔLVEDV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive (qualifier value)'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic Cardiomyopathy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2936372', 'cui_str': 'Atrio-Biventricular Pacing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034610', 'cui_str': 'Radionuclide Ventriculography'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0079031', 'cui_str': 'BIV'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",31.0,0.0860411,"BiV pacing significantly increased exercise ΔLVEDV (P = 0.004) and Δstroke volume (P = 0.008) in -LVEDV patients, but not in +LVEDV patients.","[{'ForeName': 'Ibrar', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Brodie L', 'Initials': 'BL', 'LastName': 'Loudon', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abozguia', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Donnie', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Ganesh N', 'Initials': 'GN', 'LastName': 'Shivu', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Thanh T', 'Initials': 'TT', 'LastName': 'Phan', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Maher', 'Affiliation': 'Department of Cardiovascular Medicine, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Stegemann', 'Affiliation': 'Bakken Research Centre, Medtronic Inc., Maastricht, The Netherlands.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Chow', 'Affiliation': 'Department of Cardiovascular Medicine, Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Welcome Trust Clinical Research Facility, Birmingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nightingale', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Welcome Trust Clinical Research Facility, Birmingham, UK.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Leyva', 'Affiliation': 'Department of Cardiovascular Medicine, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Vassilios S', 'Initials': 'VS', 'LastName': 'Vassiliou', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'McKenna', 'Affiliation': 'Institute of Cardiovascular Science, University College of London, London, UK.'}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Elliott', 'Affiliation': 'Institute of Cardiovascular Science, University College of London, London, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Frenneaux', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}]",European journal of heart failure,['10.1002/ejhf.1722']
522,31220933,Engaging Children to Support Parental Weight Loss: A Randomized Trial.,"Background.  Despite evidence that social network members influence the eating behaviors of adults, no study to date has had the primary aim of examining children as support partners for parents in a weight loss intervention.  Aim.  To evaluate parent adherence with eating/exercise goals and weight loss in a 6-month study engaging children as support partners.  Method.  Adults with obesity (body mass index ≥ 30 kg/m 2 ,  n  = 102) and at least one child ≥12 years were randomized to a child support or control group. In the child support group, children enrolled with their parent and engaged in a supportive behavior 2 days/week. In the control group, there was no enrolled child support. Parents in both groups selected a healthy eating strategy and daily step goal.  Results.  There was no difference in weight loss between the child support and control groups (-5.97 vs. -5.42 lbs,  p  = .81). In the child support group, 30% of children did not engage in the study. The majority of parents whose children did not engage withdrew from the study. In secondary analyses, parent adherence with eating/exercise goals increased with the days of child support ( p  < .001). For all participants, low chaos in the home environment ( p  < .04) and increased parent adherence with follow-ups ( p  < .008) predicted weight loss.  Conclusions.  We found no treatment effect of child support on weight loss. Active child support of eating/exercise goals appeared to facilitate goal adherence, while anticipated but unrealized child support may have had iatrogenic consequences. Further investigation of family-focused weight loss interventions is warranted.",2019,"In secondary analyses, parent adherence with eating/exercise goals increased with the days of child support ( p  < .001).","['at least one child ≥12 years', 'Adults with obesity (body mass index ≥ 30 kg/m 2 ,  n  = 102) and']",['child support or control group'],"['parent adherence', 'parent adherence with eating/exercise goals', 'weight loss']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0079112', 'cui_str': 'Child Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.052523,"In secondary analyses, parent adherence with eating/exercise goals increased with the days of child support ( p  < .001).","[{'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Winston', 'Affiliation': 'George Washington University Medical Faculty Associates, Washington, DC, USA.'}, {'ForeName': 'Munjireen', 'Initials': 'M', 'LastName': 'Sifat', 'Affiliation': 'University of Maryland School of Public Health, College Park, MD, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Phillips', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dietz', 'Affiliation': 'George Washington University Milken Institute School of Public Health, Washington, DC, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wikner', 'Affiliation': 'George Washington University Medical Faculty Associates, Washington, DC, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Barrow', 'Affiliation': 'George Washington University Medical Faculty Associates, Washington, DC, USA.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Khurana', 'Affiliation': 'George Washington University Medical Faculty Associates, Washington, DC, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Charlson', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119853005']
523,31962052,Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial.,"INTRODUCTION


Dental anxiety is common and causes symptomatic use of oral health services.
OBJECTIVES


The aim was to study if a short-term virtual reality intervention reduced preoperative dental anxiety.
METHODS


A randomized controlled single-center trial was conducted with 2 parallel arms in a public oral health care unit: virtual reality relaxation (VRR) and treatment as usual (TAU). The VRR group received a 1- to 3.5-min 360° immersion video of a peaceful virtual landscape with audio features and sound supporting the experience. TAU groups remained seated for 3 min. Of the powered sample of 280 participants, 255 consented and had complete data. Total and secondary sex-specific mixed effects linear regression models were completed for posttest dental anxiety (Modified Dental Anxiety Scale [MDAS] total score) and its 2 factors (anticipatory and treatment-related dental anxiety) adjusted for baseline (pretest) MDAS total and factor scores and age, taking into account the effect of blocking.
RESULTS


Total and anticipatory dental anxiety decreased more in the VRR group than the TAU group (β = -0.75, P < .001, for MDAS total score; β = -0.43, P < .001, for anticipatory anxiety score) in patients of a primary dental care clinic. In women, dental anxiety decreased more in VRR than TAU for total MDAS score (β = -1.08, P < .001) and treatment-related dental anxiety (β = -0.597, P = .011). Anticipatory dental anxiety decreased more in VRR than TAU in both men (β = -0.217, P < .026) and women (β = -0.498, P < .001).
CONCLUSION


Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
KNOWLEDGE TRANSFER STATEMENT


Dental anxiety, which is a common problem, can be reduced with short application of virtual reality relaxation applied preoperatively in the waiting room. Findings of this study indicate that it is a feasible and effective procedure to help patients with dental anxiety in normal public dental care settings.",2020,"Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
","['280 participants, 255 consented and had complete data', 'patients with dental anxiety in normal public dental care settings']","['VRR', 'virtual reality intervention', 'Virtual Reality Relaxation', 'public oral health care unit: virtual reality relaxation (VRR) and treatment as usual (TAU']","['Total and anticipatory dental anxiety', 'dental anxiety', 'Anticipatory dental anxiety', 'MDAS total and factor scores', 'MDAS total score', 'anticipatory anxiety score', 'posttest dental anxiety (Modified Dental Anxiety Scale [MDAS] total score) and its 2 factors (anticipatory and treatment-related dental anxiety) adjusted for baseline (pretest', 'Dental Anxiety', 'total MDAS score']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0029162'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]",280.0,0.082385,"Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lahti', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Suominen', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lähteenoja', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Humphris', 'Affiliation': 'Division of Populations and Behavioural Science, School of Medicine, University of St Andrews, St Andrews, UK.'}]",JDR clinical and translational research,['10.1177/2380084420901679']
524,30668631,Effects of Mindfulness-Oriented Recovery Enhancement Versus Social Support on Negative Affective Interference During Inhibitory Control Among Opioid-Treated Chronic Pain Patients: A Pilot Mechanistic Study.,"BACKGROUND


Among opioid-treated chronic pain patients, deficient response inhibition in the context of emotional distress may contribute to maladaptive pain coping and prescription opioid misuse. Interventions that aim to bolster cognitive control and reduce emotional reactivity (e.g., mindfulness) may remediate response inhibition deficits, with consequent clinical benefits.
PURPOSE


To test the hypothesis that a mindfulness-based intervention, Mindfulness-Oriented Recovery Enhancement (MORE), can reduce the impact of clinically relevant, negative affective interference on response inhibition function in an opioid-treated chronic pain sample.
METHODS


We examined data from a controlled trial comparing adults with chronic pain and long-term prescription opioid use randomized to either MORE (n = 27) treatment or to an active support group comparison condition (n = 30). Participants completed an Emotional Go/NoGo Task at pre- and post-treatment, which measured response inhibition in neutral and clinically relevant, negative affective contexts (i.e., exposure to pain-related visual stimuli).
RESULTS


Repeated-measures analysis of variance indicated that compared with the support group, participants in MORE evidenced significantly greater reductions from pre- to post-treatment in errors of commission on trials with pain-related distractors relative to trials with neutral distractors, group × time × condition F(1,55) = 4.14, p = .047, η2partial = .07. Mindfulness practice minutes and increased nonreactivity significantly predicted greater emotional response inhibition. A significant inverse association was observed between improvements in emotional response inhibition and treatment-related reductions in pain severity by 3-month follow-up.
CONCLUSIONS


Study results provide preliminary evidence that MORE enhances inhibitory control function in the context of negative emotional interference.",2019,"A significant inverse association was observed between improvements in emotional response inhibition and treatment-related reductions in pain severity by 3-month follow-up.
","['opioid-treated chronic pain patients', 'Opioid-Treated Chronic Pain Patients', 'adults with chronic pain and long-term prescription opioid']","['Mindfulness-Oriented Recovery Enhancement Versus Social Support', 'MORE', 'mindfulness-based intervention, Mindfulness-Oriented Recovery Enhancement (MORE', 'active support group comparison condition']","['response inhibition in neutral and clinically relevant, negative affective contexts (i.e., exposure to pain-related visual stimuli', 'Negative Affective Interference', 'emotional response inhibition', 'pain severity', 'Emotional Go/NoGo Task']","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0037438'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",30.0,0.171481,"A significant inverse association was observed between improvements in emotional response inhibition and treatment-related reductions in pain severity by 3-month follow-up.
","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'College of Social Work, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Myranda A', 'Initials': 'MA', 'LastName': 'Bryan', 'Affiliation': 'College of Social Work, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Priddy', 'Affiliation': 'College of Social Work, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Riquino', 'Affiliation': 'College of Social Work, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Froeliger', 'Affiliation': 'Department of Neuroscience, Medical University of South Carolina, USA.'}, {'ForeName': 'Matthew O', 'Initials': 'MO', 'LastName': 'Howard', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay096']
525,31955184,Cognitive behavioral intervention improves quality of life and perceived illness acceptance in patients after cardiac electrotherapy devices implantation.,"OBJECTIVES


This study is an attempt to provide an analysis of the influence of implementation of cognitive behavioral intervention (CBI) in patients after cardiovascular implantable electronic device (CIED) implantation on the quality of life following the procedure as well as the level of illness acceptance.
METHODS


The study group consisted of patients who underwent standard medical care related to CIED implantation and who additionally received CBI. Patients who received only standard medical care related to CIED implantation constituted a control group. CBI consisted of four sessions conducted over 30 (±3) days after the implantation. Demographic, clinicaland psychological factors were assessed.The Acceptance of Illness Scale (AIS) and EuroQol-5D (EQ-5D) were applied.
RESULTS


In total, 128 patients (women: 36.7%, mean age 64.5 ± 8.9) were included in the study. The proposed cycle of four structured CBI meetings was well accepted by the patients, which is confirmed by their high turnout for these meetings. After six months, quality of life indices were significantly improved in cardiac electrotherapy recipients assigned to CBI, including: Visual Analogue Scale EQ-5D (80.2 ± 11.8 vs. 64.9 ± 14.3; p < 0.0001) and better acceptance of illness (AIS: 35.6 ± 4.3 vs. 28.7 ± 6.1; p < 0.0001).
CONCLUSIONS


Implementation of CBI in patients after CIED implantation significantly improved indices of quality of life as well as illness acceptance, when compared to the control group of patients in standard care following electrotherapy. CBI showed multiple benefits in this population, as well as ensures the fulfilment of its expected therapeutic effect, while short duration of the intervention did not prolong the hospitalization itself.",2019,"(AIS: 35.6 ± 4.3 vs. 28.7 ± 6.1; p < 0.0001).
","['patients after cardiac electrotherapy devices implantation', 'patients after cardiovascular', 'Patients who received only standard medical care related to CIED implantation constituted a control group', '128 patients (women: 36.7%, mean age 64.5 ± 8.9) were included in the study']","['Cognitive behavioral intervention', 'cognitive behavioral intervention (CBI', 'standard medical care related to CIED implantation and who additionally received CBI', 'implantable electronic device (CIED) implantation']","['Acceptance of Illness Scale (AIS) and EuroQol-5D (EQ-5D', 'quality of life', 'quality of life and perceived illness acceptance', 'quality of life indices', 'acceptance of illness', 'Visual Analogue Scale EQ-5D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0259095', 'cui_str': 'C(2)BI'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0582608', 'cui_str': 'Acceptance of illness scale (assessment scale)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034380'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0278069', 'cui_str': 'Acceptance of illness (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",128.0,0.0627857,"(AIS: 35.6 ± 4.3 vs. 28.7 ± 6.1; p < 0.0001).
","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Sobczak-Kaleta', 'Affiliation': 'Uniwersytet Medyczny w Łodzi, Katedra i Klinika Kardiologii.'}, {'ForeName': 'Haval D', 'Initials': 'HD', 'LastName': 'Qawoq', 'Affiliation': 'Uniwersytet Medyczny w Łodzi, Katedra i Klinika Kardiologii.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Krawczyk', 'Affiliation': 'Uniwersytet Medyczny w Łodzi, Katedra i Klinika Kardiologii.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Wierzbowska-Drabik', 'Affiliation': 'Uniwersytet Medyczny w Łodzi, Katedra i Klinika Kardiologii.'}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Kasprzak', 'Affiliation': 'Uniwersytet Medyczny w Łodzi, Katedra i Klinika Kardiologii.'}]",Psychiatria polska,['10.12740/PP/109217']
526,31976639,Group-based cardiac rehabilitation interventions. A challenge for physical and rehabilitation medicine physicians: a randomized controlled trial.,"BACKGROUND


In recent decades, many studies are focused on different training modalities comparison in patients with cardiac diseases. High intensity aerobic interval training (HIAIT) has been considered as an alternative approach to moderate-intensity continuous training (MICT) in rehabilitation of patients with chronic heart failure (CHF).
AIM


To highlight the superiority of the modified group-based HIAIT intervention (m-Ullevaal) compared to the moderate-intensity continuous training (MICT), also to encourage physical and rehabilitation medicine (PRM) physicians to apply the m-Ullevaal intervention in routine cardiac rehabilitation (CR) practice.
DESIGN


А single-blind, prospective randomized controlled trial.
SETTING


Medical Center of Rehabilitation and Sports Medicine, Plovdiv, Bulgaria outpatients were enrolled.
POPULATION


One hundred and twenty subjects of both genders, mean age of 63.73±6.68 years, with stable CHF, NYHA classes II to IIIB, were randomly assigned to m-Ullevaal group (N.=60) or to MICT (N.=60) group. Both CR protocols were conducted throughout a 12-week period.
METHODS


Functional exercise capacity (FEC), assessed with six-minute walk test, and peak oxygen uptake (VO<inf>2peak</inf>), left ventricular ejection fraction (LVEF), m-Borg's perceived exertion scale (mBPES), and quality of life (QoL) were outcome measures evaluated.
RESULTS


Significant improvement in FEC (P<0.001), LVEF (P<0.001), mBPES and QoL (P<0.001), was observed 12 weeks after both CR interventions (T2). However, the participants performed m-Ullevaal protocol achieved a greater improvement compared to those performed MICT (P<0.001).
CONCLUSIONS


The m-Ullevaal protocol seems to be more beneficial and more effective compared to MICT. PRM physicians can efficiently apply the m-Ullevaal protocol in CHF patients rehabilitation.
CLINICAL REHABILITATION IMPACT


Group-based HIAIT interventions can be widely applied by PRM physicians in CHF patients rehabilitation.",2020,"RESULTS


Significant improvement in FEC (P<0.001), LVEF (P<0.001), mBPES and QoL (P<0.001), was observed 12 weeks after both CR interventions (T2).","['One hundred and twenty subjects of both genders, mean age of 63.73 ± 6.68 years, with stable CHF, NYHA classes II to IIIB', 'Bulgaria outpatients were enrolled', 'patients with chronic heart failure (CHF', 'Medical Center of Rehabilitation and Sports Medicine, Plovdiv', 'patients with cardiac diseases']","['cardiac rehabilitation interventions', 'MICT', 'High intensity aerobic interval training (HIAIT', 'moderate-intensity continuous training (MICT', 'intensity continuous training (MICT', 'modified group-based HIAIT intervention (m']","['exertion scale (mBPES), and quality of life (QoL', 'FEC (P<0.001), LVEF (P<0.001), mBPES and QoL', 'Functional exercise capacity (FEC), assessed with six-minute walk test (6MWT), and peak oxygen uptake (VO2 peak), left ventricular ejection fraction (LVEF), m']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038040', 'cui_str': 'Sports Medicine'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]",120.0,0.0265617,"RESULTS


Significant improvement in FEC (P<0.001), LVEF (P<0.001), mBPES and QoL (P<0.001), was observed 12 weeks after both CR interventions (T2).","[{'ForeName': 'Jannis V', 'Initials': 'JV', 'LastName': 'Papathanasiou', 'Affiliation': 'Department of Medical Imaging, Allergology and Physiotherapy, Faculty of Dental Medicine, Medical University of Plovdiv, Plovdiv, Bulgaria - giannipap@yahoo.co.uk.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Petrov', 'Affiliation': 'Clinic of Cardiology and Angiology, Acibadem City Clinic Cardiovascular Center University Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'Tokmakova', 'Affiliation': 'Department of Cardiology at Medical University of Plovdiv, Plovdiv, Bulgaria.'}, {'ForeName': 'Donka D', 'Initials': 'DD', 'LastName': 'Dimitrova', 'Affiliation': 'Department of Health Management and Health Economics, Faculty of Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria.'}, {'ForeName': 'Liubomir', 'Initials': 'L', 'LastName': 'Spasov', 'Affiliation': 'Cardiac Surgery Clinic Lozenets, University Hospital, Faculty of Medicine, St. Kliment Ohridski University, Sofia, Bulgaria.'}, {'ForeName': 'Nigyar S', 'Initials': 'NS', 'LastName': 'Dzhafer', 'Affiliation': 'Department of Health Policy and Management, Faculty of Public Health, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Tsekoura', 'Affiliation': 'Aretaieio Hospital, Athens Medical School, Athens, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Dionyssiotis', 'Affiliation': 'First Physical Medicine and Rehabilitation Department, National Rehabilitation Center, Athens, Greece.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Ferreira', 'Affiliation': 'Augusto Motta University Center, Rio de Janeiro, Brazil.'}, {'ForeName': 'Agnaldo J', 'Initials': 'AJ', 'LastName': 'Lopes', 'Affiliation': 'Augusto Motta University Center, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Rosulescu', 'Affiliation': 'Department of Physical Therapy and Sports Medicine, Faculty of Physical Education and Sport, University of Craiova, Craiova, Romania.'}, {'ForeName': 'Calogero', 'Initials': 'C', 'LastName': 'Foti', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clinical Sciences and Translational Medicine, Tor Vergata University, Rome, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06013-X']
527,31858823,Does trunk muscle training with an oscillating rod improve urinary incontinence after radical prostatectomy? A prospective randomized controlled trial.,"OBJECTIVE


To investigate the effect of a new therapeutic approach, using an oscillating rod to strength the pelvic floor and deep abdominal musculature and to speed up recovery of continence after radical prostatectomy.
DESIGN


Prospective randomized controlled clinical trial.
SETTING


Inpatient uro-oncology rehabilitation clinic.
SUBJECTS


Ninety-three (intervention group (IG)) and ninety-one patients (control group (CG)) with urinary incontinence after prostatectomy were examined.
INTERVENTION


All patients were randomly allocated to either standard pelvic floor muscle exercises and oscillating rod therapy (IG) or standard pelvic floor muscle exercises and relaxation therapy (CG).
MAIN OUTCOME MEASURES


Urinary incontinence (1- and 24-hour pad test) was assessed, and health-related quality of life (HRQL; Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire) was measured for all patients before and after three weeks of treatment.
RESULTS


One hundred and eighty-four patients (mean (SD) age: 64.1 (6.94) years) completed the study. The IG showed a significant reduction in urinary incontinence (1-hour pad test:  P  = 0.008, 24-hour pad test:  P  = 0.012) and a significant improvement of HRQL ( P  = 0.017) compared with CG. Continence was significantly improved in both groups (1-hour pad test: 22.6-8.5 g (IG) vs. 23.0-18.1 g (CG)/24-hour pad test: 242.9-126.7 g (IG) vs. 237.6-180.9 g (CG)).
CONCLUSION


The study demonstrated that a combination of conventional continence exercises and the new oscillation rod training increased abdominal and pelvic floor musculature and speeded up recovery of continence after radical prostatectomy.",2020,"The IG showed a significant reduction in urinary incontinence (1-hour pad test:  P  = 0.008, 24-hour pad test:  P  = 0.012) and a significant improvement of HRQL ( P  = 0.017) compared with CG.","['Inpatient uro-oncology rehabilitation clinic', 'One hundred and eighty-four patients (mean (SD) age: 64.1 (6.94) years) completed the study', 'Ninety-three (intervention group (IG)) and ninety-one patients (control group (CG)) with urinary incontinence after prostatectomy were examined']","['radical prostatectomy', 'standard pelvic floor muscle exercises and oscillating rod therapy (IG) or standard pelvic floor muscle exercises and relaxation therapy (CG', 'conventional continence exercises and the new oscillation rod training']","['health-related quality of life (HRQL; Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire', 'Continence', 'Urinary incontinence ', 'urinary incontinence', 'HRQL']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic (environment)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0206427', 'cui_str': 'Retinal Rod'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]",184.0,0.0367153,"The IG showed a significant reduction in urinary incontinence (1-hour pad test:  P  = 0.008, 24-hour pad test:  P  = 0.012) and a significant improvement of HRQL ( P  = 0.017) compared with CG.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Heydenreich', 'Affiliation': 'Division of Sports and Training Science, Vogtland-Klinik Bad Elster, Bad Elster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Puta', 'Affiliation': 'Department of Sports Medicine and Health Promotion, Friedrich Schiller University Jena, Jena, Germany.'}, {'ForeName': 'Holger Hw', 'Initials': 'HH', 'LastName': 'Gabriel', 'Affiliation': 'Department of Sports Medicine and Health Promotion, Friedrich Schiller University Jena, Jena, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Dietze', 'Affiliation': 'Division of Sports and Training Science, Vogtland-Klinik Bad Elster, Bad Elster, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wright', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Dirk-Henrik', 'Initials': 'DH', 'LastName': 'Zermann', 'Affiliation': 'Division of Sports and Training Science, Vogtland-Klinik Bad Elster, Bad Elster, Germany.'}]",Clinical rehabilitation,['10.1177/0269215519893096']
528,31955952,When patient-reported experience does not match change in clinical outcomes: A perplexing view from the inside of a diabetes distress intervention.,"AIMS


To assess between-group differences in participant experiences in a two-arm diabetes distress (DD) reduction RCT and to determine their relationship to clinical outcomes (reductions in DD and HbA1C).
METHODS


For high DD adults with Type 1 diabetes and HbA1c ≥7.5% participating in T1-REDEEM, we evaluated post intervention 5-point ratings of overall program ""helpfulness"" and program component ""helpfulness,"" along with open-ended feedback statements using 10 qualitative codes. We compared responses of those in OnTrack, a distressed-focused intervention, with KnowIt, an education/management intervention.
RESULTS


Those in OnTrack reported significantly higher levels of overall program helpfulness and greater helpfulness of each component of the program, greater group support, far fewer negative experiences, and more active and meaningful group engagement than those who participated in KnowIt. Ratings of helpfulness were unrelated to reductions in DD and HbA1C in both study arms. As previously reported, these findings occurred despite significant reductions in both DD and HbA1C in both arms with no between-group differences.
CONCLUSIONS


Findings highlight the importance of addressing the personal experience of diabetes interventions in clinical care as separate, distinct outcomes. Personal experience may not always be related to changes in traditional clinical indicators.",2020,"Those in OnTrack reported significantly higher levels of overall program helpfulness and greater helpfulness of each component of the program, greater group support, far fewer negative experiences, and more active and meaningful group engagement than those who participated in KnowIt.",['For high DD adults with Type 1 diabetes and HbA1c ≥7.5% participating in T1-REDEEM'],[],"['DD and HbA1C', 'overall program helpfulness', 'intervention 5-point ratings of overall program ""helpfulness"" and program component ""helpfulness,"" along with open-ended feedback statements']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",[],"[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0275413,"Those in OnTrack reported significantly higher levels of overall program helpfulness and greater helpfulness of each component of the program, greater group support, far fewer negative experiences, and more active and meaningful group engagement than those who participated in KnowIt.","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA. Electronic address: larry.fisher@ucsf.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Polonsky', 'Affiliation': 'University of California, San Diego, San Diego, CA, USA; Behavioral Diabetes Institute, San Diego, CA, USA.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Bowyer', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107533']
529,31944806,Efficacy of a two-session repetitive negative thinking-focused acceptance and commitment therapy (ACT) protocol for depression and generalized anxiety disorder: A randomized waitlist control trial.,"This parallel randomized controlled trial aimed to evaluate the effect of acceptance and commitment therapy (ACT) focused on disrupting repetitive negative thinking (RNT) versus a waitlist control (WLC) in the treatment of depression and generalized anxiety disorder (GAD). Forty-eight participants with a main diagnosis of depression and/or GAD were allocated by means of simple randomization to a 2-session RNT-focused ACT intervention or to the WLC. The primary outcomes were emotional symptoms as measured by the Depression, Anxiety, and Stress Scales-21. Process outcomes included ACT- and RNT-related measures: general RNT, experiential avoidance, cognitive fusion, values, and generalized pliance. At the 1-month follow-up, linear mixed effects models showed that the intervention was efficacious in reducing emotional symptoms ( d  = 2.42, 95% confidence interval [1.64, 3.19]), with 94.12% of participants in the RNT-focused ACT condition showing clinically significant change in the Depression, Anxiety, and Stress Scales-21 total scores versus 9.09% in the WLC condition (70% vs. 8% in intention-to-treat analysis). The intervention effects were maintained at the 3-month follow-up. No adverse events were found. A very brief RNT-focused ACT intervention was highly effective in the treatment of depression and GAD. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"At the 1-month follow-up, linear mixed effects models showed that the intervention was efficacious in reducing emotional symptoms ( d  ","['Forty-eight participants with a main diagnosis of depression', 'depression and generalized anxiety disorder', 'depression and generalized anxiety disorder (GAD']","['RNT-focused ACT intervention', 'two-session repetitive negative thinking-focused acceptance and commitment therapy (ACT) protocol', '2-session RNT-focused ACT intervention or to the WLC', 'acceptance and commitment therapy (ACT', 'repetitive negative thinking (RNT) versus a waitlist control (WLC']","['adverse events', 'emotional symptoms as measured by the Depression, Anxiety, and Stress Scales-21', 'emotional symptoms', 'Depression, Anxiety, and Stress Scales-21 total scores', 'ACT- and RNT-related measures: general RNT, experiential avoidance, cognitive fusion, values, and generalized pliance']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0424134', 'cui_str': 'Negative Thinking'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",48.0,0.0788807,"At the 1-month follow-up, linear mixed effects models showed that the intervention was efficacious in reducing emotional symptoms ( d  ","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Ruiz', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Peña-Vargas', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'Eduar S', 'Initials': 'ES', 'LastName': 'Ramírez', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Suárez-Falcón', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'María B', 'Initials': 'MB', 'LastName': 'García-Martín', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'García-Beltrán', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'Ángela M', 'Initials': 'ÁM', 'LastName': 'Henao', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Monroy-Cifuentes', 'Affiliation': 'Faculty of Psychology.'}, {'ForeName': 'Pili D', 'Initials': 'PD', 'LastName': 'Sánchez', 'Affiliation': 'Faculty of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000273']
530,31964172,"Does adding case management to standard rehabilitation affect functional ability, pain, or the rate of return to work after lumbar spinal fusion? A randomized controlled trial with two-year follow-up.","OBJECTIVE


To examine the effect of a case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation in patients undergoing lumbar spinal fusion.
DESIGN


A randomized controlled trial with a two-year follow-up.
SETTINGS


Outpatient clinics of a university hospital and a general hospital.
SUBJECTS


In total, 82 patients undergoing lumbar spinal fusion.
INTERVENTIONS


The patients were randomized one-to-one to case manager-assisted rehabilitation (case manager group) or no case manager-assisted rehabilitation (control group). Both groups received usual physical rehabilitation. The case manager-assisted rehabilitation programme included a preoperative meeting with a case manager to determine a rehabilitation plan, postsurgical meetings, phone meetings, and voluntary workplace visits or roundtable meetings.
MAIN MEASURES


Primary outcome was the Oswestry Disability Index. Secondary outcomes were back pain, leg pain, and return to work.
RESULTS


Of the 41 patients in the case manager group, 49% were men, with the mean age of 46.1 (±8.7 years). In the control group, 51% were male, with the mean age of 47.4 (±8.9 years). No statistically significant between-group differences were found regarding any outcomes. An overall group effect of 4.1 points (95% confidence interval (CI): -1.8; 9.9) was found on the Oswestry Disability Index, favouring the control group. After two years, the relative risk of return to work was 1.18 (95% CI: 0.8; 1.7), favouring the case manager group.
CONCLUSION


The case manager-assisted rehabilitation programme had no effect on the patients' functional disability or back and leg pain compared to usual physical rehabilitation. The study lacked power to evaluate the impact on return to work.",2020,The case manager-assisted rehabilitation programme had no effect on the patients' functional disability or back and leg pain compared to usual physical rehabilitation.,"['41 patients in the case manager group, 49% were men, with the mean age of 46.1 (±8.7 years', 'patients undergoing lumbar spinal fusion', '82 patients undergoing lumbar spinal fusion', 'Outpatient clinics of a university hospital and a general hospital']","['case manager-assisted rehabilitation programme', 'case manager-assisted rehabilitation (case manager group) or no case manager-assisted rehabilitation (control group', 'usual physical rehabilitation', 'rehabilitation plan, postsurgical meetings, phone meetings, and voluntary workplace visits or roundtable meetings']","[""patients' functional disability or back and leg pain"", 'Oswestry Disability Index', 'relative risk of return to work', 'back pain, leg pain, and return to work']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion (procedure)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",82.0,0.0657272,The case manager-assisted rehabilitation programme had no effect on the patients' functional disability or back and leg pain compared to usual physical rehabilitation.,"[{'ForeName': 'Lisa Gregersen', 'Initials': 'LG', 'LastName': 'Oestergaard', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Finn Bjarke', 'Initials': 'FB', 'LastName': 'Christensen', 'Affiliation': 'Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Cody Eric', 'Initials': 'CE', 'LastName': 'Bünger', 'Affiliation': 'Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Søgaard', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Holm', 'Affiliation': 'Orthopedic Department, Regional Hospital Silkeborg, Silkeborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Helmig', 'Affiliation': 'Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Claus Vinther', 'Initials': 'CV', 'LastName': 'Nielsen', 'Affiliation': 'Section of Social Medicine and Rehabilitation, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Clinical rehabilitation,['10.1177/0269215519897106']
531,31682586,Development of a Deep Learning Model for Dynamic Forecasting of Blood Glucose Level for Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Type 2 diabetes mellitus (T2DM) is a major public health burden. Self-management of diabetes including maintaining a healthy lifestyle is essential for glycemic control and to prevent diabetes complications. Mobile-based health data can play an important role in the forecasting of blood glucose levels for lifestyle management and control of T2DM.
OBJECTIVE


The objective of this work was to dynamically forecast daily glucose levels in patients with T2DM based on their daily mobile health lifestyle data including diet, physical activity, weight, and glucose level from the day before.
METHODS


We used data from 10 T2DM patients who were overweight or obese in a behavioral lifestyle intervention using mobile tools for daily monitoring of diet, physical activity, weight, and blood glucose over 6 months. We developed a deep learning model based on long short-term memory-based recurrent neural networks to forecast the next-day glucose levels in individual patients. The neural network used several layers of computational nodes to model how mobile health data (food intake including consumed calories, fat, and carbohydrates; exercise; and weight) were progressing from one day to another from noisy data.
RESULTS


The model was validated based on a data set of 10 patients who had been monitored daily for over 6 months. The proposed deep learning model demonstrated considerable accuracy in predicting the next day glucose level based on Clark Error Grid and ±10% range of the actual values.
CONCLUSIONS


Using machine learning methodologies may leverage mobile health lifestyle data to develop effective individualized prediction plans for T2DM management. However, predicting future glucose levels is challenging as glucose level is determined by multiple factors. Future study with more rigorous study design is warranted to better predict future glucose levels for T2DM management.",2019,"Mobile-based health data can play an important role in the forecasting of blood glucose levels for lifestyle management and control of T2DM.
","['Type 2 Diabetes Mellitus', '10 patients who had been monitored daily for over 6 months', 'patients with T2DM based on their daily mobile health lifestyle data including diet, physical activity, weight, and glucose level from the day before', 'individual patients', '10 T2DM patients who were overweight or obese in a behavioral lifestyle intervention using mobile tools for daily monitoring of diet, physical activity, weight, and blood glucose over 6 months']",[],['Blood Glucose Level'],"[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",[],"[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",,0.0239665,"Mobile-based health data can play an important role in the forecasting of blood glucose levels for lifestyle management and control of T2DM.
","[{'ForeName': 'Syed Hasib Akhter', 'Initials': 'SHA', 'LastName': 'Faruqui', 'Affiliation': 'Department of Mechanical Engineering, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Center on Smart and Connected Health Technologies, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Rajitha', 'Initials': 'R', 'LastName': 'Meka', 'Affiliation': 'Department of Mechanical Engineering, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alaeddini', 'Affiliation': 'Department of Mechanical Engineering, University of Texas at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Chengdong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Center on Smart and Connected Health Technologies, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shirinkam', 'Affiliation': 'Department of Mathematics and Statistics, University of the Incarnate Word, San Antonio, TX, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center on Smart and Connected Health Technologies, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}]",JMIR mHealth and uHealth,['10.2196/14452']
532,31972630,Effect of High-Intensity Training and Asthma on the V˙O2 Kinetics of Adolescents.,"PURPOSE


High-intensity interval training (HIIT) represents a potent stimulus to the dynamic oxygen uptake (V˙O2) response in adults, but whether the same is evident in youth is unknown. HIIT has also been suggested to place a lower demand on the respiratory system, decreasing the likelihood of exacerbation in those with respiratory conditions, such as asthma.
METHODS


Sixty-nine adolescents (13.6 ± 0.9 yr; 36 asthma) took part, 35 of which (17 asthma) participated in a 30-min HIIT intervention three times a week for 6 months. Each participant completed an incremental ramp test to volitional exhaustion and three heavy-intensity constant work rate tests to determine the dynamic V˙O2, heart rate, and deoxyhemoglobin response at baseline, midintervention, postintervention and at a 3-month follow-up.
RESULTS


There was no influence of asthma at baseline or in response to the intervention. Participants in the intervention group demonstrated a faster V˙O2 time constant (τp) after intervention (intervention: 29.2 ± 5.7 s vs control: 34.2 ± 6.5 s; P = 0.003), with these differences maintained at follow-up (intervention: 32.5 ± 5.5 s vs control: 37.3 ± 8.7 s; P = 0.008). The intervention was associated with a speeding of the concentration of deoxyhemoglobin τ (pre: 20.1 ± 4.7 s vs post: 18.2 ± 4.1 s; P = 0.05) compared with a slowing over the same time period in the control participants (pre: 17.9 ± 4.9 s vs post: 20.1 ± 4.6 s; P = 0.012). Heart rate kinetics were not altered (pre: 46.5 ± 12.2 s vs post: 47.7 ± 11.1 s; P = 0.98).
CONCLUSION


These findings highlight the potential utility of school-based HIIT as a strategy to enhance the V˙O2 kinetics of youth, regardless of the presence of asthma.",2020,"HR kinetics were not altered (Pre: 46.5±12.2 vs. Post: 47.7±11.1 s; P=0.98).
","['Adolescents', 'Sixty-nine adolescents (13.6±0.9 years; 36 asthma) took part, 35 of which (17 asthma']","['High-Intensity Training and Asthma', 'High-intensity interval training (HIIT']","['dynamic oxygen uptake (V[Combining Dot Above]O2), heart rate (HR) and deoxyhaemoglobin ([HHb]) response', 'faster V[Combining Dot Above]O2 time constant', 'HR kinetics']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0057437', 'cui_str': 'T-state hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",69.0,0.0213114,"HR kinetics were not altered (Pre: 46.5±12.2 vs. Post: 47.7±11.1 s; P=0.98).
","[{'ForeName': 'Melitta A', 'Initials': 'MA', 'LastName': 'McNarry', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Charles O N', 'Initials': 'CON', 'LastName': 'Winn', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Gwyneth A', 'Initials': 'GA', 'LastName': 'Davies', 'Affiliation': 'Swansea University Medical School, Singleton Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'William T B', 'Initials': 'WTB', 'LastName': 'Eddolls', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mackintosh', 'Affiliation': 'Applied Sports Technology, Exercise and Medicine (A-STEM) Research Centre, College of Engineering, Bay Campus, Swansea University, Swansea, UNITED KINGDOM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002270']
533,31898323,Does forgiving in a collectivistic culture affect only decisions to forgive and not emotions? REACH forgiveness collectivistic in Indonesia.,"According to some theorising, in collectivistic societies, forgiveness is mainly enacted to maintain relationships, not engender emotional transformation. This present study was designed to explore whether forgiveness affects decisional and emotional forgiveness in Indonesia, a country categorised as collectivistic. The evidence-based REACH Forgiveness psychoeducational group intervention was adapted to collectivistic culture (REACH forgiveness collectivistic; REACH-FC), and its efficacy was assessed in a randomised controlled trial. Undergraduates in Indonesia (N = 97; 24 male; 73 female; ages 16-21) were randomly assigned within a 2 × 3(S) quasi-experimental repeated-measures design comparing immediate treatment (IT) and waiting list (WL) conditions [Condition (IT, WL) × Time ([S] 3 time points). Harmonious value, a personality variable assessing the strength of participants' desire for group harmony, was the covariate. The condition × time (S) interactions for both decisional and emotional forgiveness were significant, challenging some previous literature. Clearly, not all forms of collectivism have similar effects when individuals and communities deal with transgressions.",2020,"The condition × time (S) interactions for both decisional and emotional forgiveness were significant, challenging some previous literature.",['Undergraduates in Indonesia (N\xa0=\xa097; 24 male; 73 female; ages 16-21'],"['2\u2009×\u20093(S) quasi-experimental repeated-measures design comparing immediate treatment (IT) and waiting list (WL) conditions [Condition (IT, WL)\u2009×\u2009Time']",[],"[{'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",[],73.0,0.0424285,"The condition × time (S) interactions for both decisional and emotional forgiveness were significant, challenging some previous literature.","[{'ForeName': 'Ni Made Taganing', 'Initials': 'NMT', 'LastName': 'Kurniati', 'Affiliation': 'Faculty of Psychology, Universitas Gunadarma, Depok, Indonesia.'}, {'ForeName': 'Everett L', 'Initials': 'EL', 'LastName': 'Worthington', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Nilam', 'Initials': 'N', 'LastName': 'Widyarini', 'Affiliation': 'Faculty of Psychology, Universitas Gunadarma, Depok, Indonesia.'}, {'ForeName': 'Ajeng Furida', 'Initials': 'AF', 'LastName': 'Citra', 'Affiliation': 'Faculty of Psychology, Universitas Gunadarma, Depok, Indonesia.'}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Dwiwardani', 'Affiliation': 'Department of Psychology, Azusa Pacific University, Azusa, CA, USA.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12648']
534,31984502,Growing Together-Effects of a school-based intervention promoting positive self-beliefs and social integration in recently immigrated children.,"We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society. Coaches encouraged groups of tandems, consisting of one RI and one child brought up in Germany each, to engage in cooperative activities designed to strengthen positive self-beliefs and perception of equal status. In a quasi-experimental control-group design (N = 318), we compared the 30 children (12 RI) who participated in our intervention between pre-test and post-test with a reference group. Self-beliefs were measured via self-reports, social integration via sociometric peer-nominations. The reference group (n = 288 children) included all children who did not participate in the intervention between pre-test and post-test: (a) 12 children (7 RI) of a waiting control group and (b) all classmates of both the students of the intervention and the waiting control group. Post-test self-beliefs were more positive in children having participated in the intervention. The intervention did not affect social integration: Neither the number of classmates nominating a student nor the number of peers the respective student nominated increased. Possibly, the intervention initiated self-reinforcing processes which support social integration over longer time periods.",2020,We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society.,"['30 children (12 RI) who participated in our intervention between pre-test and post-test with a reference group', 'recently immigrated children', 'The reference group (n = 288 children) included all children who did not participate in the intervention between pre-test and post-test: (a) 12 children (7 RI) of a waiting control group and (b) all classmates of both the students of the intervention and the waiting control group']",['school-based intervention'],"['Self-beliefs', 'number of classmates nominating a student nor the number of peers the respective student nominated increased', 'social integration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",288.0,0.015598,We present a school-based intervention geared to foster the social integration of recently immigrated (RI) primary school children by creating repeated positive contact situations with classmates brought up in the receiving society.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hannover', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Kreutzmann', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Jannika', 'Initials': 'J', 'LastName': 'Haase', 'Affiliation': 'Fachbereich Erziehungswissenschaft und Psychologie, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Lysann', 'Initials': 'L', 'LastName': 'Zander', 'Affiliation': 'Institut für Erziehungswissenschaft, Leibniz University Hannover, Hanover, Germany.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12653']
535,31965916,Comparison of Balance Program Outcomes among Independently Living and Assisted Living Residents.,"Falls are a serious health concern for older adults. The purpose of this single group repeated measures intervention was to compare effects of the fall prevention program, A Matter of Balance Volunteer Lay Leader Model (MOB-VLLM), between individuals residing independently in the community (n = 24) and those residing in assisted living (AL) (n = 15). Surveys were completed immediately post intervention and 6 weeks, and 3, 6, 9, 12, and 18 months after. Being younger and living in AL predicted program attendance. Perceived control of fall risk increased post intervention (PS t-test: t = 4.004, df = 38, p<0.001), and the degree fear of falling impacts social activity was lower post intervention (WSR: Z = -3.104, p = 0.002). Current level of exercise was higher post intervention (WSR: Z = -2.099, p = 0.036). Control of falls, impact on social activity, fear of falling, and depression scores remained the same post intervention through follow up for both groups.",2020,"Control of falls, impact on social activity, fear of falling, and depression scores remained the same post intervention through follow up for both groups.","['Independently Living and Assisted Living Residents', 'individuals residing independently in the community (n = 24) and those residing in assisted living (AL) (n = 15', 'older adults']","['fall prevention program, A Matter of Balance Volunteer Lay Leader Model (MOB-VLLM']","['social activity, fear of falling, and depression scores', 'Current level of exercise', 'degree fear of falling impacts social activity']","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.013425,"Control of falls, impact on social activity, fear of falling, and depression scores remained the same post intervention through follow up for both groups.","[{'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Katrancha', 'Affiliation': 'Division of Nursing and Health Sciences, University of Pittsburgh at Johnstown, Johnstown, PA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Bonachea', 'Affiliation': 'Division Natural Sciences, University of Pittsburgh at Johnstown, Johnstown, PA, USA.'}]",Western journal of nursing research,['10.1177/0193945919899438']
536,31950399,The Effect of Iodine-Containing Vitamin Supplementation During Pregnancy on Thyroid Function in Late Pregnancy and Postpartum Depression in an Iodine-Sufficient Area.,"The purpose of this study was to investigate the effect of iodine supplementation during pregnancy on thyroid function and also its effect on postpartum depression in an iodine-sufficient area. Healthy pregnant women were divided into three groups: group A (vitamin iodine-150) receiving vitamin containing 150 μg iodine, group B (vitamin iodine-0) receiving vitamin without iodine, and group C (no vitamin) receiving no vitamin. General information was collected by questionnaire and thyroid function was determined in the third trimester of pregnancy. Depression was assessed 1 month postpartum by the Edinburgh postnatal depression scale (EPDS). The results showed that there was no significant difference in thyroid-stimulating hormone (TSH) level among the three groups (P > 0.05). FT 4  concentration was significantly lower in group A (n = 234: 10.68 pmol/L) than in group B (n = 220: 11.47 pmol/L) and group C (n = 195: 11.64 pmol/L) (P < 0.05), However, it was still within the normal range. EPDS scores obtained from group B (3.50) and group C (3.00) were similar but markedly lower than group A (5.00) (P < 0.05). Despite the difference in the EPDS score, the prevalence of postpartum depression was not significantly different among the three groups. In conclusion, 150 μg/day iodine supplementation for pregnant women in areas with adequate iodine had little effect on thyroid function in the third trimester, and serum FT 4  level could not be increased. Iodine supplementation during pregnancy also had no significant effect on postpartum depression.",2020,FT 4  concentration was significantly lower in group A (n = 234: 10.68 pmol/L) than in group B (n = ,"['Late Pregnancy and Postpartum Depression in an Iodine-Sufficient Area', 'Healthy pregnant women', 'pregnant women']","['iodine supplementation', 'vitamin iodine-150) receiving vitamin containing 150\xa0μg iodine, group B (vitamin iodine-0) receiving vitamin without iodine, and group C (no vitamin) receiving no vitamin', 'Iodine-Containing Vitamin Supplementation', 'Iodine supplementation']","['questionnaire and thyroid function', 'thyroid-stimulating hormone (TSH) level', 'FT 4  concentration', 'Depression', 'postpartum depression', 'EPDS score, the prevalence of postpartum depression', 'EPDS scores', 'Edinburgh postnatal depression scale (EPDS', 'thyroid function']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C1533658', 'cui_str': 'Vitamin supplement therapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}]",,0.0223597,FT 4  concentration was significantly lower in group A (n = 234: 10.68 pmol/L) than in group B (n = ,"[{'ForeName': 'Zixiao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology and Metabolism and Institute of Endocrinology, The First Hospital of China Medical University, 155 Nanjing Bei Street, Shenyang, 110001, Liaoning, People's Republic of China.""}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Gynaecology and Obstetrics, Shenyang Maternity and Child Health Hospital, Shenyang, 110000, Liaoning, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': ""Department of Gynaecology and Obstetrics, Shenyang Fifth People Hospital, Shenyang, 110023, Liaoning, People's Republic of China.""}, {'ForeName': 'Yunping', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': ""Department of Gynaecology and Obstetrics, Shenyang Maternity and Child Health Hospital, Shenyang, 110000, Liaoning, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Gynaecology and Obstetrics, Shenyang Maternity and Child Health Hospital, Shenyang, 110000, Liaoning, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': ""Department of Gynaecology and Obstetrics, Shenyang Maternity and Child Health Hospital, Shenyang, 110000, Liaoning, People's Republic of China.""}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Cui', 'Affiliation': ""Department of Gynaecology and Obstetrics, Shenyang Maternity and Child Health Hospital, Shenyang, 110000, Liaoning, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Gynaecology and Obstetrics, Shenyang Maternity and Child Health Hospital, Shenyang, 110000, Liaoning, People's Republic of China.""}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': ""Department of Endocrinology and Metabolism and Institute of Endocrinology, The First Hospital of China Medical University, 155 Nanjing Bei Street, Shenyang, 110001, Liaoning, People's Republic of China. hxguan@vip.126.com.""}]",Biological trace element research,['10.1007/s12011-020-02032-y']
537,31812487,Influence of azithromycin and allograft rejection on the post-lung transplant microbiota.,"BACKGROUND


Alterations in the lung microbiota may drive disease development and progression in patients with chronic respiratory diseases. Following lung transplantation (LTx), azithromycin is used to both treat and prevent chronic lung allograft dysfunction (CLAD). The objective of this study was to determine the association between azithromycin use, CLAD, acute rejection, airway inflammation, and bacterial microbiota composition and structure after LTx.
METHODS


Bronchoalveolar lavage samples (n = 219) from 69 LTx recipients (azithromycin, n = 32; placebo, n = 37) from a previously conducted randomized placebo-controlled trial with azithromycin were analyzed. Samples were collected at discharge, 1, and 2 years following randomization and at CLAD diagnosis. Bacterial microbial community composition and structure was determined using 16S ribosomal RNA gene sequencing and associated with clinically important variables.
RESULTS


At discharge and following 1 and 2 years of azithromycin therapy, no clear differences in microbial community composition or overall diversity were observed. Moreover, no changes in microbiota composition were observed in CLAD phenotypes. However, acute rejection was associated with a reduction in community diversity (p = 0.0009). Significant correlations were observed between microbiota composition, overall diversity, and levels of inflammatory cytokines in bronchoalveolar lavage, particularly CXCL8.
CONCLUSIONS


Chronic azithromycin usage did not disturb the bacterial microbiota. However, acute rejection episodes were associated with bacterial dysbiosis.",2020,"At discharge and following 1 and 2 years of azithromycin therapy, no clear differences in microbial community composition or overall diversity were observed.","['patients with chronic respiratory diseases', 'Bronchoalveolar lavage samples (n\u202f=\u202f219) from 69 LTx recipients (azithromycin, n\u202f=\u202f32; placebo, n\u202f=\u202f37']","['placebo', 'azithromycin', 'lung transplantation (LTx), azithromycin']","['microbial community composition or overall diversity', 'acute rejection episodes', 'CLAD, acute rejection, airway inflammation, and bacterial microbiota composition and structure after LTx', 'microbiota composition', 'community diversity', 'acute rejection', 'microbiota composition, overall diversity, and levels of inflammatory cytokines in bronchoalveolar lavage, particularly CXCL8']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}]",,0.029789,"At discharge and following 1 and 2 years of azithromycin therapy, no clear differences in microbial community composition or overall diversity were observed.","[{'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Spence', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Vanaudenaerde', 'Affiliation': 'Leuven Lung Transplant Unit, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gísli G', 'Initials': 'GG', 'LastName': 'Einarsson', 'Affiliation': ""School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mcdonough', 'Affiliation': 'Leuven Lung Transplant Unit, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lee', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Geert M', 'Initials': 'GM', 'LastName': 'Verleden', 'Affiliation': 'Leuven Lung Transplant Unit, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Elborn', 'Affiliation': ""School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Lieven J', 'Initials': 'LJ', 'LastName': 'Dupont', 'Affiliation': 'Leuven Lung Transplant Unit, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Van Herck', 'Affiliation': 'Leuven Lung Transplant Unit, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Deirdre F', 'Initials': 'DF', 'LastName': 'Gilpin', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Vos', 'Affiliation': 'Leuven Lung Transplant Unit, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Tunney', 'Affiliation': ""School of Pharmacy, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Stijn E', 'Initials': 'SE', 'LastName': 'Verleden', 'Affiliation': 'Leuven Lung Transplant Unit, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium. Electronic address: stijn.verleden@kuleuven.be.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2019.11.007']
538,29079990,"The Effects of Synbiotic Supplementation on Carotid Intima-Media Thickness, Biomarkers of Inflammation, and Oxidative Stress in People with Overweight, Diabetes, and Coronary Heart Disease: a Randomized, Double-Blind, Placebo-Controlled Trial.","Synbiotics are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions. The aim of this study was to evaluate the effects of synbiotic supplementation on carotid intima-media thickness (CIMT), biomarkers of inflammation, and oxidative stress in people with overweight, diabetes, and coronary heart disease (CHD). This randomized, double-blind, placebo-controlled trial was conducted and involved 60 people with overweight, diabetes, and CHD, aged 50-85 years old. Participants were randomly allocated into two groups to take either synbiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 10 9  CFU/g each) plus 800 mg inulin or placebo (n = 30 each group) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention period to determine metabolic variables. After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 3101.7 ± 5109.1 vs. - 6.2 ± 3163.6 ng/mL, P = 0.02), plasma malondialdehyde (MDA) (- 0.6 ± 1.0 vs. - 0.1 ± 0.3 μmol/L, P = 0.01), and significantly increased nitric oxide (NO) levels (+ 7.8 ± 10.3 vs. - 3.6 ± 6.9 μmol/L, P < 0.001). We did not observe any significant changes of synbiotic supplementation on other biomarkers of oxidative stress and CIMT levels. Overall, synbiotic supplementation for 12 weeks among people with overweight, diabetes, and CHD had beneficial effects on serum hs-CRP, plasma NO, and MDA levels; however, it did not have any effect on other biomarkers of oxidative stress and CIMT levels.",2019,"After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly reduced serum high-sensitivity C-reactive protein (hs-CRP)","['People with Overweight, Diabetes, and Coronary Heart Disease', 'people with overweight, diabetes, and coronary heart disease (CHD', '60 people with overweight, diabetes, and CHD, aged 50-85\xa0years old']","['synbiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2\xa0×\xa010 9 \xa0CFU/g each) plus 800\xa0mg inulin or placebo', 'placebo', 'Placebo', 'Synbiotic Supplementation', 'placebo, synbiotic supplementation', 'synbiotic supplementation']","['serum high-sensitivity C-reactive protein (hs-CRP', 'oxidative stress and CIMT levels', 'serum hs-CRP, plasma', 'MDA levels', 'nitric oxide (NO) levels', 'Carotid Intima-Media Thickness, Biomarkers of Inflammation, and Oxidative Stress', 'Fasting blood samples', 'carotid intima-media thickness (CIMT), biomarkers of inflammation, and oxidative stress', 'plasma malondialdehyde (MDA']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0037910', 'cui_str': 'Spices'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0439362', 'cui_str': 'cfu/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}]",60.0,0.462337,"After the 12-week intervention, compared with the placebo, synbiotic supplementation significantly reduced serum high-sensitivity C-reactive protein (hs-CRP)","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Farrokhian', 'Affiliation': 'Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Raygan', 'Affiliation': 'Department of Cardiology, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Soltani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Science Department, Science Faculty, Islamic Azad University, Tehran Central Branch, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Sharifi Esfahani', 'Affiliation': 'Department of Oncology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Karami', 'Affiliation': 'Department of Urology, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-017-9343-1']
539,31967375,Blue-blocking glasses as additive treatment for mania: Effects on actigraphy-derived sleep parameters.,"Improvement of sleep is a central treatment goal for patients in a manic state. Blue-blocking (BB) glasses as adjunctive treatment hasten overall recovery from mania. This method is an evolvement from dark therapy and builds on the discovery of the blue-light-sensitive retinal ganglion cell that signals daytime to the brain. We report effects of adjunctive BB glasses on actigraphy-derived sleep parameters for manic inpatients as compared to placebo. Hospitalized patients with bipolar disorder in a manic state aged 18-70 years were recruited from five clinics in Norway from February 2012 to February 2015. The participants were randomly allocated to wearing BB glasses or placebo (clear glasses) as an adjunctive treatment from 18:00 to 08:00 hours for seven consecutive nights. Sleep and wake were monitored by actigraphy. From 32 eligible patients, 10 patients in each group qualified for the group analyses. The BB group's mean sleep efficiency was significantly higher at night 5 as compared to the placebo group (92.6% vs. 83.1%, p = .027). The 95% confidence interval (CI) was 89.4%-95.8% in the BB group and 75.9%-90.3% in the placebo group. There were fewer nights of interrupted sleep in the BB group: 29.6% versus 43.8% in the placebo group. The BB group received less-intensive sleep-promoting pharmacological treatment and showed significantly higher sleep efficiency and more consolidated sleep as compared to the placebo group. Our findings suggest sleep-promoting effects through deactivating mechanisms. Adjunctive BB glasses seem to be useful for improving sleep for manic patients in the hospital setting.",2020,The BB group received less-intensive sleep-promoting pharmacological treatment and showed significantly higher sleep efficiency and more consolidated sleep as compared to the placebo group.,"['Hospitalized patients with bipolar disorder in a manic state aged 18-70\xa0years were recruited from five clinics in Norway from February 2012 to February 2015', '32 eligible patients, 10 patients in each group qualified for the group analyses', 'patients in a manic state', 'mania', 'manic inpatients']","['placebo', 'adjunctive BB glasses', 'Blue-blocking (BB) glasses', 'wearing BB glasses or placebo (clear glasses']","['sleep efficiency', 'interrupted sleep', 'Improvement of sleep', 'mean sleep efficiency', 'consolidated sleep']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0775015,The BB group received less-intensive sleep-promoting pharmacological treatment and showed significantly higher sleep efficiency and more consolidated sleep as compared to the placebo group.,"[{'ForeName': 'Tone E G', 'Initials': 'TEG', 'LastName': 'Henriksen', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole Bernt', 'Initials': 'OB', 'LastName': 'Fasmer', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Schoeyen', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ieva', 'Initials': 'I', 'LastName': 'Leskauskaite', 'Affiliation': 'Department for Psychosis Treatment, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bjorke-Bertheussen', 'Affiliation': 'Division of Psychiatry, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Ytrehus', 'Affiliation': 'Division of Mental Health Care, Valen Hospital, Fonna Local Health Authority, Haugesund, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}]",Journal of sleep research,['10.1111/jsr.12984']
540,31902653,Therapeutic lifestyle change intervention improved metabolic syndrome criteria and is complementary to amlodipine/atorvastatin.,"AIMS


To examine whether addition of amlodipine (5 mg)/atorvastatin (10 mg) A/A to Therapeutic Lifestyle change intervention (TLC) would beneficially modulate Metabolic Syndrome (MetS) and oxidized low-density lipoprotein (Ox-LDL) levels.
METHODS


Patients with MetS (n = 53) were randomized to TLC + placebo or TLC + A/A for 12 months. Anthropometric measurements, blood pressure (BP), lipid profile, plasma Ox-LDL, and area under the curve of free fatty acid (AUC FFA ) during oral glucose tolerance test, a marker of adipose tissue health, were assessed before and after the intervention.
RESULTS


Twenty-six patients completed the study with an overall improvement of MetS (p = 0.02). TLC + placebo was beneficial in reversing MetS comparable to TLC + A/A (54% vs. 39%; p = 0.08). Both treatments decreased systolic BP (p ≤ 0.01). TLC + A/A also decreased diastolic BP and triglyceride levels. The changes in Ox-LDL levels directly correlated with changes in weight in the TLC-placebo group (r = 0.64; p = 0.04). AUC FFA  determined the loss of fat mass (r = 0.472, p = 0.03).
CONCLUSIONS


1) Addition of A/A has the advantage of improving the lipid profile and BP; but TLC alone was comparable to TLC + A/A in improving MetS; 2) weight change determines the TLC-associated change in Ox-LDL levels; and 3) AT metabolic health is a significant predictor of TLC-associated loss of body fat mass.",2020,TLC + placebo was beneficial in reversing MetS comparable to TLC ,['Patients with MetS (n\u202f=\u202f53'],"['TLC-placebo', 'TLC\u202f+\u202fplacebo', 'TLC', 'amlodipine/atorvastatin', 'Therapeutic Lifestyle change intervention', 'amlodipine', 'TLC\u202f+\u202fplacebo or TLC', 'Therapeutic lifestyle change intervention']","['Metabolic Syndrome (MetS) and oxidized low-density lipoprotein cholestero Ox-LDL) levels', 'systolic BP', 'diastolic BP and triglyceride levels', 'Ox-LDL levels', 'AUC FFA  determined the loss of fat mass', 'lipid profile and BP', 'overall improvement of MetS', 'metabolic syndrome criteria', 'Anthropometric measurements, blood pressure (BP), lipid profile, plasma Ox-LDL, and area under the curve of free fatty acid (AUC FFA ) during oral glucose tolerance test, a marker of adipose tissue health']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1329978', 'cui_str': 'Amlodipine / atorvastatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0373606', 'cui_str': 'Free fatty acids measurement (procedure)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0518236,TLC + placebo was beneficial in reversing MetS comparable to TLC ,"[{'ForeName': 'Hanaa S', 'Initials': 'HS', 'LastName': 'Sallam', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA; Department of Physiology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}, {'ForeName': 'Demidmaa R', 'Initials': 'DR', 'LastName': 'Tuvdendorj', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Ishwarlal', 'Initials': 'I', 'LastName': 'Jialal', 'Affiliation': 'California North-State University College of Medicine, Elk Grove, CA, USA.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Chandalia', 'Affiliation': 'Bay Area Metabolic Health, Baytown, TX, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Abate', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA; Bay Area Metabolic Health, Baytown, TX, USA. Electronic address: nicola.abate13@gmail.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.107480']
541,31953483,A noninferiority within-person study comparing the accuracy of transperineal to transrectal MRI-US fusion biopsy for prostate-cancer detection.,"BACKGROUND


Magnetic resonance imaging (MRI) and ultrasound (US) fusion prostate-biopsies can be performed in a transrectal (TR-fusion) or transperineal (TP-fusion) approach. Prospective comparative evidence is limited. In this study we compared the detection rate of clinically-significant prostate-cancer (csPCa) within an index lesion between TR and TP-fusion.
PATIENTS AND METHODS


This was a prospective, noninferiority, and within-person trial. Men scheduled for MRI-US-fusion with a discrete MRI PI-RRAD ≥ 3 lesion were included. A dominant index lesion was determined for each subject and sampled by TR and TP-fusion during the same session. The order of biopsies was randomized and equipment was reset to avoid chronological and incorporation bias. For each subject, the index lesion was sampled 4-6 times in each approach. All biopsies were performed using Navigo fusion software (UC-Care, Yokneam, Israel). csPCa was defined as: Grade Group ≥ 2 or cancer-core length ≥ 6 mm. We used a noninferiority margin of 10% and a one-sided alpha level of 5%.
RESULTS


Seventy-seven patients completed the protocol. Median age was 68.2 years (IQR:64.2-72.2), median PSA was 8.9 ng/ml (IQR:6.18-12.2). Ten patients (13%) were biopsy naive, others (87%) had a previous biopsy. csPCa was detected in 32 patients (42%). All of these cases were detected by TP-fusion, while only 20 (26%) by TR-fusion. Absolute difference for csPCa diagnosis was 15.6 (CI 90% 27.9-3.2%) in favor of TP-fusion (p = 0.029). TP-fusion was noninferior to TR-fusion. The lower boundary of the 90% confidence-interval between TP-fusion and TR-fusion was greater than zero, therefore TP-fusion was also found to be superior. Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
CONCLUSIONS


In this study, TP-fusion biopsies were found to be noninferior and superior to TR-fusion biopsies in detecting csPCa within MRI-visible index lesion. Centers experienced in both TP and TR-fusion should consider these results when choosing biopsy method.",2020,"Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
","['Ten patients (13%) were biopsy naive, others (87%) had a previous biopsy', 'Men scheduled for MRI-US-fusion with a discrete MRI PI-RRAD\u2009≥\u20093 lesion were included', 'Seventy-seven patients completed the protocol']","['Magnetic resonance imaging (MRI) and ultrasound (US) fusion prostate-biopsies', 'transperineal to transrectal MRI-US fusion biopsy']","['csPCa', 'csPCa diagnosis', 'TP-fusion', 'median PSA', 'detection rate of clinically-significant prostate-cancer (csPCa']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",77.0,0.0226582,"Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history).
","[{'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Ber', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Niv', 'Initials': 'N', 'LastName': 'Segal', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Tamir', 'Affiliation': 'Department of Imaging, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Benjaminov', 'Affiliation': 'Division of Imaging, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Yakimov', 'Affiliation': 'Department of Pathology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Sela', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Halstauch', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Baniel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kedar', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margel', 'Affiliation': 'Division of Urology, Rabin Medical Center, Petah-Tikva, Israel. sdmargel@gmail.com.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0205-7']
542,31705729,Evaluation of 18F-FDG PET/CT as an early imaging biomarker for response monitoring after radiochemotherapy using cetuximab in head and heck squamous cell carcinoma.,"BACKGROUND


To determine whether  18  F-PET/CT is able to identify treatment response as early as 1 week after the end of chemoradiotherapy, whether  18  F-PET/CT can identify prognostic markers concerning progression free survival and can identify patients who need additional consolidation therapy.
METHODS


A total of 54 patients with head and neck cancer were prospectively enrolled in this single-center, randomized study from 03/2012-04/2015. Patients underwent FDG-PET/CT imaging at three predefined time points: pretreatment (PET/CT1), 1 week postprimary radiochemotherapy (PET/CT2) and 3 months postprimary radiochemotherapy (PET/CT3). Tumors were assessed quantitatively based on size and glucose uptake (SUVmax) concerning response at each time point. Response assessment was correlated with progression free survival. All patients had a minimum follow-up period of 18 months. Multivariate regression analysis was performed to find independent predictors for progression free survival (PFS).
RESULTS


Thirty-two (32) patients (64%) overall remained disease free, 11 patients (22%) had recurrence and 7 patients (14%) had persistent disease. There was no significantly different metabolic parameter ratio found concerning responders and nonresponders at posttreatment (PET/CT2 and 3) time points (P > .05) during clinical follow-up. Multivariate regression analysis demonstrated both SUVmax and diameter assessed at time point PET/CT3 represent independent predictors of progression free survival (PFS). There was also no statistically significant difference in PFS between responders and nonresponders by means of PET/CT2 in both study arms (P > .05). Imaging responders at time point PET/CT3 showed a significantly longer PFS compared to nonresponders after the end of consolidation therapy (P < .01).
CONCLUSIONS


Early response of head/neck cancer after radiochemotherapy can be accurately assessed with PET/CT 1 week after RCT. SUVmax and lesion diameter are independent predictors of PFS at time point PET/CT3. PET/CT2 has no prognostic value concerning PFS and cannot identify high risk patients for consolidation therapy. Imaging responders showed a significantly longer PFS compared to nonresponders and therefore PET/CT might serve as a prognostic biomarker.
TRIAL REGISTRATION


Clinical Trials.gov identifier: NCT01435252.",2020,"Imaging responders showed a significantly longer PFS compared to nonresponders and therefore PET/CT might serve as a prognostic biomarker.
","['head and heck squamous cell carcinoma', '54 patients with head and neck cancer']","['radiochemotherapy', 'radiochemotherapy using cetuximab', '18F-FDG PET/CT', 'FDG-PET/CT', 'PET/CT2', 'radiochemotherapy (PET/CT2) and 3 months postprimary radiochemotherapy (PET/CT3']","['size and glucose uptake (SUVmax) concerning response', 'progression free survival (PFS', 'progression free survival', 'metabolic parameter ratio', 'PFS']","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0046056', 'cui_str': 'fludeoxyglucose (18F)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0500679,"Imaging responders showed a significantly longer PFS compared to nonresponders and therefore PET/CT might serve as a prognostic biomarker.
","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'de Galiza Barbosa', 'Affiliation': 'Department Nuclear Medicine, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Gerhard F', 'Initials': 'GF', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, Head & Neck Surgery, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin W', 'Initials': 'MW', 'LastName': 'Huellner', 'Affiliation': 'Department Nuclear Medicine, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stolzmann', 'Affiliation': 'Department Nuclear Medicine, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department Nuclear Medicine, University Hospital Zurich, Zurich, Switzerland.'}]",Head & neck,['10.1002/hed.25975']
543,31843692,Prophylactic Enoxaparin Adjusted by Anti-Factor Xa Peak Levels Compared with Recommended Thromboprophylaxis and Rates of Clinically Evident Venous Thromboembolism in Surgical Oncology Patients.,"BACKGROUND


Studies among populations at high risk of venous thromboembolism (VTE) have demonstrated that recommended doses for enoxaparin thromboprophylaxis are associated with high incidence of subprophylactic anti-factor Xa (anti-Xa) levels. This study examines the efficacy and safety of dose-adjusted enoxaparin guided by anti-Xa levels.
STUDY DESIGN


Patients undergoing abdominal cancer operation had dose adjustments based on peak anti-Xa levels to attain a target of >0.20 IU/mL were prospectively enrolled and compared with a historic cohort of patients receiving recommended thromboprophylaxis. Incidence of in-hospital VTE and major bleeding after changes in enoxaparin dosing were monitored.
RESULTS


The study population comprised 197 patients-64 patients in the prospective intervention group and 133 patients in the control group. Baseline characteristic were similar between the intervention and control groups, with the exception of the Caprini score (8.09 vs 7.26; p = 0.013). In the intervention group, 50 of 64 patients (78.1%) initially had subprophylactic peak anti-Xa levels. The VTE rates were lower in the intervention group than the control group (0% vs 8.27%; p = 0.018). There were no differences in major bleeding events (3.12% vs 1.50%; p = 0.597), rates of postoperative packed RBC transfusion (17.2% vs 23.3%; p = 0.426), or mean Hgb on discharge (9.58 vs 9.37g/dL; p = 0.414). Therapeutic anti-Xa levels correlated positively with age (65.7 vs 58.2 years; p = 0.022) and correlated negatively with operating room time (203 vs 281 minutes; p = 0.032) and BMI (25.3 vs 29.2 kg/m 2 ; p = 0.037).
CONCLUSIONS


Thromboprophylactic enoxaparin 40 mg daily is often associated with subprophylactic peak anti-Xa levels. Dose adjustment based on anti-Xa levels increased the daily enoxaparin dose, resulting in a lower rate of in-hospital VTE without increased risk of bleeding.",2020,"VTE rates were lower in the intervention group than the control group (0% vs 8.27%, P=0.018).","['Surgical Oncology Patients', '197 patients - 64 patients in the prospective intervention group and 133 patients in the control group', 'Patients undergoing abdominal cancer surgery had dose adjustments based on peak anti-Xa levels to attain a target of >0.20 IU/ml were prospectively enrolled and compared to a historic cohort of patients receiving recommended thromboprophylaxis', 'populations at high risk of venous thromboembolism (VTE']","['enoxaparin', 'enoxaparin thromboprophylaxis', 'Prophylactic Enoxaparin', 'Thromboprophylactic enoxaparin']","['major bleeding events', 'Caprini score', 'operating room time', 'Incidence of in-hospital VTE and major bleeding', 'BMI', 'anti-Xa levels', 'risk of bleeding', 'subprophylactic peak anti-Xa levels', 'VTE rates', 'mean hemoglobin on discharge', 'rate of postoperative packed red blood cell transfusion', 'Therapeutic anti-Xa levels', 'efficacy and safety']","[{'cui': 'C1515090', 'cui_str': 'Surgical Oncology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0920424'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4040353', 'cui_str': 'At high risk of venous thromboembolism (finding)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0199962', 'cui_str': 'Transfusion of packed red blood cells (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",197.0,0.028984,"VTE rates were lower in the intervention group than the control group (0% vs 8.27%, P=0.018).","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kramme', 'Affiliation': 'Department of General Surgery, Kalamazoo, MI.'}, {'ForeName': 'Paya', 'Initials': 'P', 'LastName': 'Sarraf', 'Affiliation': 'Western Michigan University, Homer Stryker MD School of Medicine, Kalamazoo, MI.'}, {'ForeName': 'Gitonga', 'Initials': 'G', 'LastName': 'Munene', 'Affiliation': 'Department of General Surgery, Kalamazoo, MI; Western Michigan University, Homer Stryker MD School of Medicine, Kalamazoo, MI; Western Michigan Cancer Center, Kalamazoo, MI. Electronic address: gmunene.md@gmail.com.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.11.012']
544,30957981,"Weight loss induced by deep transcranial magnetic stimulation in obesity: A randomized, double-blind, sham-controlled study.","AIM


To test the hypothesis that deep transcranial magnetic stimulation (dTMS) reduces food craving and causes weight loss via neuromodulation.
MATERIALS AND METHODS


This pilot study was designed as a randomized, double-blind, sham-controlled study. A total of 33 obese people (nine men, 24 women, mean age 48.1 ± 10.6 years, body mass index [BMI] 36.9 ± 4.7 kg/m 2  ) were randomized and completed the study: 13 participants underwent a 5-week treatment with high-frequency (HF) dTMS (18 Hz; HF group), 10 were treated with low-frequency (LF) dTMS (1 Hz; LF group), and 10 were sham-treated (sham group). Food craving, and metabolic and neuro-endocrine variables were evaluated at baseline, after the 5-week treatment, and at follow-up visits (1 month, 6 months, 1 year after the end of treatment).
RESULTS


The mixed-model analysis for repeated measures showed a significant interaction of time and groups for body weight (P = 0.001) and BMI (P = 0.001), with a significant body weight (-7.83 ± 2.28 kg; P = 0.0009) and BMI (-2.83 ± 0.83, P = 0.0009) decrease in the HF versus the sham group. A decreasing trend in food craving in the HF versus the LF and sham groups (P = 0.073) was observed. A significant improvement of metabolic and physical activity variables was found (P < 0.05) in the HF group.
CONCLUSIONS


We demonstrated the safety and efficacy of dTMS, in addition to physical exercise and a hypocaloric diet, in reducing body weight for up to 1 year in obese people. We hypothesize that a possible mechanism of HF dTMS treatment is modulation of the dopaminergic pathway and stimulation of physical activity.",2019,A decreasing trend in food craving in the HF versus the LF and sham groups (P = 0.073) was observed.,"['33 obese people (nine men, 24 women, mean age 48.1\u2009±\u200910.6 years, body mass index [BMI] 36.9\u2009±\u20094.7 kg/m 2  ) were randomized and completed the study: 13 participants underwent a', 'obese people', 'obesity']","['physical exercise and a hypocaloric diet', 'dTMS', 'HF dTMS', 'low-frequency (LF) dTMS', 'deep transcranial magnetic stimulation (dTMS', '5-week treatment with high-frequency (HF) dTMS']","['food craving', 'safety and efficacy', 'BMI', 'Weight loss', 'Food craving, and metabolic and neuro-endocrine variables', 'metabolic and physical activity variables', 'body weight']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}]","[{'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",33.0,0.364682,A decreasing trend in food craving in the HF versus the LF and sham groups (P = 0.073) was observed.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferrulli', 'Affiliation': 'Endocrinology and Metabolism Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Macrì', 'Affiliation': 'Endocrinology and Metabolism Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy.'}, {'ForeName': 'Ileana', 'Initials': 'I', 'LastName': 'Terruzzi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Massarini', 'Affiliation': 'Endocrinology and Metabolism Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ambrogi', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Adamo', 'Affiliation': 'Endocrinology and Metabolism Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Milani', 'Affiliation': 'Scientific Directorate, IRCCS Policlinico San Donato, San Donato Milanese, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Luzi', 'Affiliation': 'Endocrinology and Metabolism Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13741']
545,31926484,Body composition and neuromotor development in the year after NICU discharge in premature infants.,"BACKGROUND


Hypothesis: neuromotor development correlates to body composition over the first year of life in prematurely born infants and can be influenced by enhancing motor activity.
METHODS


Forty-six female and 53 male infants [27 ± 1.8 (sd) weeks] randomized to comparison or exercise group (caregiver provided 15-20 min daily of developmentally appropriate motor activities) completed the year-long study. Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS) were assessed.
RESULTS


AIMS at 1 year correlated with LBM (r = 0.32, p < 0.001) in the whole cohort. However, there was no effect of the intervention. LBM increased by ~3685 g (p < 0.001)); insulin-like growth factor-1 (IGF-1) was correlated with LBM (r = 0.36, p = 0.002). IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125). LBM and bone mineral density were significantly lower and IGF-1 higher in the females at 1 year.
CONCLUSIONS


We found an association between neuromotor development and LBM suggesting that motor activity may influence LBM. Our particular intervention was ineffective. Whether activities provided largely by caregivers to enhance motor activity in prematurely born infants can affect the interrelated (1) balance of growth and inflammation mediators, (2) neuromotor development, (3) sexual dimorphism, and/or (4) body composition early in life remains unknown.",2020,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","['Forty-six female and 53 male infants [27\u2009±\u20091.8 (sd) weeks', 'prematurely born infants', 'premature infants']",['randomized to comparison or exercise group (caregiver provided 15-20\u2009min daily of developmentally appropriate motor activities'],"['IL-1RA (an inflammatory biomarker', 'Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS', 'insulin-like growth factor-1 (IGF-1', 'Body composition and neuromotor development', 'motor activity', 'LBM and bone mineral density', 'LBM']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0222045'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",46.0,0.0798796,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","[{'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Cooper', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA. dcooper@hs.uci.edu.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kepes', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Candice Taylor', 'Initials': 'CT', 'LastName': 'Lucas', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Fadia', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zalidvar', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Nitzan', 'Initials': 'N', 'LastName': 'Dror', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Soliman', 'Affiliation': ""Miller Women's and Children's Hospital, Long Beach, CA, USA.""}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}]",Pediatric research,['10.1038/s41390-020-0756-2']
546,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9']
547,31926605,"Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Intravenous Siponimod: A Randomized, Open-label Study in Healthy Subjects.","PURPOSE


The goal of this study was to assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of intravenous (IV) siponimod in healthy subjects.
METHODS


This randomized, open-label study was conducted in 2 parts. In Part 1, a total of 16 eligible subjects received either a single oral dose of siponimod (0.25 mg) followed by a single IV infusion (0.25 mg/3 h) in Sequence 1, or vice versa in Sequence 2. In Part 2, a total of 17 eligible subjects received single IV infusions of siponimod (1 mg/24 h).
FINDINGS


No clinically relevant effect on mean 5-minute or hourly average heart rate was observed following the siponimod IV dosing regimens and both remained above 50 beats/min. Observed atrioventricular blocks and sinus pauses were asymptomatic. The mean change in absolute lymphocyte count from baseline was comparable for the siponimod 0.25 mg oral regimen and the two IV siponimod regimens. Oral siponimod displayed a good absolute bioavailability of 84%. The mean peak exposure of oral siponimod was approximately 48% lower than that of IV siponimod. The M17 metabolite was found to be the most prominent systemic metabolite of siponimod in humans.
IMPLICATIONS


Siponimod IV infusions were well tolerated, with safety and PD (absolute lymphocyte count) profiles similar to those of oral siponimod. The PD/PK findings supported the development of an innovative rapid IV titration regimen for patients with intracerebral hemorrhage.",2020,"FINDINGS


No clinically relevant effect on mean 5-minute or hourly average heart rate was observed following the siponimod IV dosing regimens and both remained above 50 beats/min.","['Healthy Subjects', '17 eligible subjects received', 'healthy subjects', 'patients with intracerebral hemorrhage', '16 eligible subjects']","['single IV infusions of siponimod', 'single oral dose of\xa0siponimod', 'Intravenous Siponimod', 'intravenous (IV) siponimod']","['mean 5-minute or hourly average heart rate', 'Safety, Tolerability, Pharmacodynamics and Pharmacokinetics', 'mean change in absolute lymphocyte count', 'mean peak exposure of oral siponimod', 'safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3657824', 'cui_str': '1-(4-(1-((E)-4-cyclohexyl-3-trifluoromethylbenzyloxyimino)-ethyl)-2-ethylbenzyl)-azetidine-3-carboxylic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3657824', 'cui_str': '1-(4-(1-((E)-4-cyclohexyl-3-trifluoromethylbenzyloxyimino)-ethyl)-2-ethylbenzyl)-azetidine-3-carboxylic acid'}]",,0.022533,"FINDINGS


No clinically relevant effect on mean 5-minute or hourly average heart rate was observed following the siponimod IV dosing regimens and both remained above 50 beats/min.","[{'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Shakeri-Nejad', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland. Electronic address: kasra.shakeri-nejad@novartis.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gardin', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Neelakantham', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Dumitras', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Legangneux', 'Affiliation': 'Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.014']
548,31926893,Laser pretreatment for the attenuation of planned surgical scars: A randomized self-controlled hemi-scar pilot study.,"BACKGROUND


Nonsurgical scar attenuation options include compression garments, silicone gel, intralesional drug therapy, radiation therapy, laser, and light therapies. Laser application preceding surgical intervention has been shown to modify the wound-healing process and affect subsequent scar formation. The objective of this study was to evaluate the safety, efficacy, and final cosmesis of a single presurgical laser treatment on surgical scar formation.
METHODS


This was a randomized, controlled, intraindividual split-scar pilot study with blinded assessments of treated versus untreated planned incision sites. One half of each planned scar was treated by means of an Erbium glass, 1540 nm laser, 24 h before surgery, and the other half was not treated and served as the control. Clinical evaluations and the measurements of patient and physician POSAS scales were done at 1 and 12 months following surgery.
RESULTS


Eleven patients completed the study and were included in the analyses. Laser pretreatment showed a significant beneficial effect compared with no treatment. Both the patient and physician mean Patient and Observer Scar Assessment Scale scores were significantly lower for the laser-treated half of the scars compared with the control side (1.55 to 3.00, p = 0.02 and 2.28 to 4.42, p = 0.03). There was a highly significant interobserver correlation in the evaluation of the overall posttreatment changes (r = 0.904, p < 0.001).
CONCLUSION


A single presurgical laser treatment of a planned incision site is a simple, safe, and painless strategy to significantly improve the final scar appearance.",2020,"There was a highly significant interobserver correlation in the evaluation of the overall posttreatment changes (r = 0.904, p < 0.001).
","['Eleven patients completed the study and were included in the analyses', 'planned surgical scars']","['Laser pretreatment', 'single presurgical laser treatment']","['Observer Scar Assessment Scale scores', 'patient and physician POSAS scales', 'safety, efficacy, and final cosmesis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0334150', 'cui_str': 'Surgical scar (morphologic abnormality)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",,0.0309942,"There was a highly significant interobserver correlation in the evaluation of the overall posttreatment changes (r = 0.904, p < 0.001).
","[{'ForeName': 'Or', 'Initials': 'O', 'LastName': 'Friedman', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel. Electronic address: or.friedman@gmail.com.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Gofstein', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Arad', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Gur', 'Affiliation': 'Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizman Street, Tel Aviv 6423906, Israel.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Sprecher', 'Affiliation': 'Division of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Artzi', 'Affiliation': 'Division of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2019.11.046']
549,31922999,Effect of Midazolam in Addition to Propofol and Opiate Sedation on the Quality of Recovery After Colonoscopy: A Randomized Clinical Trial.,"BACKGROUND


There is a concern that midazolam, when used as a component of sedation for colonoscopy, may impair cognition and prolong recovery. We aimed to identify whether midazolam produced short- and longer-term effects on multiple dimensions of recovery including cognition.
METHODS


A 2-center double-blinded, placebo-controlled, parallel-group, randomized, phase IV study with a 1:1 allocation ratio was conducted in adults ≥18 years of age undergoing elective outpatient colonoscopy, with sufficient English language proficiency to complete the Postoperative Quality of Recovery Scale (PostopQRS). Participants were administered either midazolam (0.04 mg·kg) or an equivalent volume of 0.9% saline before sedation with propofol with or without an opiate. The primary outcome was incidence of recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy, which was analyzed using a χ test. Secondary outcomes included recovery in other domains of the PostopQRS over time, time to eye-opening, and hospital stay, and patient and endoscopist satisfaction. All hypotheses were defined before recruitment.
RESULTS


During September 2015 to June 2018, 406 patients were allocated to either midazolam (n = 201) or placebo (n = 205), with one withdrawn before allocation. There was no significant difference in recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy (midazolam 86.8% vs placebo 88.7%, odds ratio, 0.838; 95% confidence interval [CI], 0.42-1.683; P= .625). Furthermore, there was no difference in recovery over time in the cognitive domain of the PostopQRS (P = .534). Overall recovery of the PostopQRS increased over time but was not different between groups. Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS. Patient and endoscopist satisfaction were high and not different. There were no differences in time to eye-opening (midazolam 9.4 ± 12.8 minutes vs placebo 7.3 ± 0.7 minutes; P = .055), or time to hospital discharge (midazolam 103.4 ± 1.4 minutes vs placebo 98.4 ± 37.0 minutes; P = .516).
CONCLUSIONS


The addition of midazolam 0.04 mg·kg as adjunct to propofol and opiate sedation for elective colonoscopy did not show evidence of any significant differences in recovery in the cognitive domain of the PostopQRS, overall quality of recovery as measured by the PostopQRS, or emergence and hospital discharge times. The use of midazolam should be determined by the anesthesiologist.",2020,"Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS.","['During September 2015 to June 2018, 406 patients', 'adults ≥18 years of age undergoing elective outpatient colonoscopy, with sufficient English language proficiency to complete the Postoperative Quality of Recovery Scale (PostopQRS']","['midazolam', 'equivalent volume of 0.9% saline before sedation with propofol with or without an opiate', 'Midazolam', 'placebo', 'Propofol and Opiate Sedation']","['Overall recovery of the PostopQRS', 'recovery in other domains of the PostopQRS over time, time to eye-opening, and hospital stay, and patient and endoscopist satisfaction', 'nociceptive, emotive, activities-of-daily-living domains of the PostopQRS', 'cognitive domain of the PostopQRS, overall quality of recovery as measured by the PostopQRS, or emergence and hospital discharge times', 'incidence of recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy', 'time to hospital discharge', 'Patient and endoscopist satisfaction', 'cognitive domain of the PostopQRS', 'time to eye-opening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0376245', 'cui_str': 'English language (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0222045'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",406.0,0.627951,"Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS.","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Gurunathan', 'Affiliation': 'From the *The Prince Charles Hospital, Brisbane, Queensland, Australia †University of Queensland, Brisbane, Queensland, Australia ‡Queensland University of Technology and University of Sunshine Coast, Queensland, Australia §Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia ‖Department of Anesthesia and Pain Management, The Royal Melbourne Hospital, Melbourne, Victoria, Australia ¶Outcomes Research Consortium, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Rahman', 'Affiliation': ''}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Vandeleur', 'Affiliation': ''}, {'ForeName': 'Sweta', 'Initials': 'S', 'LastName': 'Sriram', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harch', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Boggett', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bowyer', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004620']
550,31923017,Lavage With Lidocaine and Adrenaline Mixture Reduces the Early Side Effects of Septorhinoplasty.,"BACKGROUND


Pain, ecchymosis, and edema are well-known temporary consequences of septorhinoplasty procedure. They give rise to patient's complaints, discomfort, and dissatisfaction, increasing the patient's anxiety and recovery time in the early postoperative course. Several approaches have been described to reduce the level of these complaints.The aim of this clinical study was to determine the effect of nasal lavage with lidocaine and adrenaline mixture on early postoperative levels of pain, edema, and ecchymosis in 24 hours after a septorhinoplasty procedure.
METHODS


This study included 40 consecutive patients who underwent septorhinoplasty procedure in which nasal septum was entirely dissected and corrected. Patients were randomly divided into 2 groups of 20 patients. At the end of the operation, incisions were closed with sutures, and both blood and seroma collections beneath the flaps were sufficiently drained by means of finger pressure, and then in patients of group A (control group), 5 mL of saline solution was given under the dorsal nasal flap to make lavage and in patients of group B (study group), 5 mL of 2% lidocaine with 1:100,000 adrenaline was given to the area under the dorsal nasal flaps. Five minutes later, nasal package and splint were applied and the operation was finished.Patients were evaluated for the level of pain sensation, degree of periorbital edema, and ecchymosis at the 1st, 3rd, 6th, 12th, and 24th hours postoperatively. Overall satisfaction scores were also determined at the 24th hour.
RESULTS


A total of 40 patients (19 males and 21 females) between 18 and 42 years of age with a mean ± standard deviation of 24.5 ± 4.52 years were included in the study. Statistically significant differences were found between the A and B groups with regard to early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores, suggesting the effectivity of the lavage with lidocaine-adrenaline mixture on the early postoperative pain, edema, and ecchymosis relief.
CONCLUSIONS


Lavage of nasal flaps with lidocaine-adrenaline mixture seems an effective and simple way in the control of early postoperative pain, edema, and ecchymosis in septorhinoplasty patients. In addition, it considerably reduces total analgesic consumption and patients' discomfort, leading to high level of satisfaction.",2020,"Statistically significant differences were found between the A and B groups with regard to early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores, suggesting the effectivity of the lavage with lidocaine-adrenaline mixture on the early postoperative pain, edema, and ecchymosis relief.
","['40 consecutive patients who underwent septorhinoplasty procedure in which nasal septum was entirely dissected and corrected', '24 hours after a septorhinoplasty procedure', 'septorhinoplasty patients', '40 patients (19 males and 21 females) between 18 and 42 years of age with a mean ± standard deviation of 24.5 ± 4.52 years were included in the study']","['saline solution was given under the dorsal nasal flap to make lavage', 'lidocaine with 1:100,000 adrenaline', 'lidocaine and adrenaline mixture', 'lidocaine-adrenaline mixture', 'Lidocaine and Adrenaline']","['Overall satisfaction scores', 'early postoperative pain, edema, and ecchymosis relief', 'early postoperative levels of pain, edema, and ecchymosis', 'early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores', 'total analgesic consumption', 'level of pain sensation, degree of periorbital edema, and ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0027432', 'cui_str': 'Nasal Septum'}, {'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0440841', 'cui_str': 'Nasal flap (substance)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema (disorder)'}]",40.0,0.0242988,"Statistically significant differences were found between the A and B groups with regard to early postoperative pain, edema, ecchymosis, analgesic use, and satisfaction scores, suggesting the effectivity of the lavage with lidocaine-adrenaline mixture on the early postoperative pain, edema, and ecchymosis relief.
","[{'ForeName': 'Nazım', 'Initials': 'N', 'LastName': 'Gümüş', 'Affiliation': 'From the Plastic, Reconstructive and Aesthetic Surgery, Department of Mersin University Medical Faculty, Mersin, Turkey.'}]",Annals of plastic surgery,['10.1097/SAP.0000000000002219']
551,31927671,Effect of a balanced Korean diet on metabolic risk factors among overweight/obese Korean adults: a randomized controlled trial.,"PURPOSE


This study was to see the effects of a balanced Korean diet (BKD) on metabolic risk factors in overweight or obese Korean adults, comparing with those of a typical American diet (TAD) and a diet recommended by the 2010 Dietary Guidelines for Americans (2010DGA).
METHODS


The study was designed as a randomized crossover controlled trial, in which 61 overweight or obese volunteers were divided into six groups and each consumed the BKD, 2010DGA, and TAD in a random order for 4 weeks separated by 2-week washout intervals. Anthropometric indices, blood pressure, blood lipid content, fasting blood glucose, and blood insulin level were measured at the beginning and end of each diet period.
RESULTS


A total of 54 participants completed the trial. The BKD caused more significant reductions of body mass index (BMI) (p < 0.001), body fat percent (p < 0.001), blood total cholesterol (p < 0.001), and low-density lipoprotein (LDL) cholesterol (p = 0.007) compared with the 2010DGA or TAD (all p values for differences between diets < 0.05). All three diets significantly lowered blood triglyceride levels (p < 0.05). The BKD decreased high-density lipoprotein (HDL) cholesterol (p = 0.001) and increased fasting blood glucose (p = 0.018), whereas TAD and 2010DGA increased HDL cholesterol and did not affect blood glucose levels. Furthermore, the BKD significantly decreased the proportion of individuals with elevated total cholesterol (p < 0.001) and LDL cholesterol (p < 0.01), whereas the 2010DGA significantly reduced the number of obese individuals (p < 0.05), and the TAD decreased the number of participants with elevated triglyceride levels (p < 0.05), but increased that of those with elevated LDL cholesterol (p < 0.05).
CONCLUSIONS


The Korean diet based on dietary guidelines improved metabolic risk factors such as BMI, body fat percent, and blood lipid profiles in overweight or obese Korean adults. These results provide evidence to recommend the Korean diet for preventing various metabolic diseases.
CLINICAL TRIAL REGISTRATION


The trial was registered at the Clinical Research Information Service (CRIS) in Korea, the primary registry of the World Health Organization (WHO) international clinical trial registry platform, under number KCT0002437.",2020,"The BKD decreased high-density lipoprotein (HDL) cholesterol (p = 0.001) and increased fasting blood glucose (p = 0.018), whereas TAD and 2010DGA increased HDL cholesterol and did not affect blood glucose levels.","['overweight or obese Korean adults, comparing with those of a typical American diet (TAD) and a diet recommended by the 2010 Dietary Guidelines for Americans (2010DGA', 'overweight/obese Korean adults', '61 overweight or obese volunteers', '54 participants completed the trial', 'overweight or obese Korean adults']","['balanced Korean diet', 'balanced Korean diet (BKD']","['BKD decreased high-density lipoprotein (HDL) cholesterol', 'blood glucose levels', 'elevated triglyceride levels', 'low-density lipoprotein (LDL) cholesterol', 'number of obese individuals', 'blood triglyceride levels', 'metabolic risk factors such as BMI, body fat percent, and blood lipid profiles', 'Anthropometric indices, blood pressure, blood lipid content, fasting blood glucose, and blood insulin level', 'body mass index (BMI', 'fasting blood glucose', 'TAD and 2010DGA increased HDL cholesterol', 'metabolic risk factors', 'proportion of individuals with elevated total cholesterol', 'LDL cholesterol', 'elevated LDL cholesterol', 'body fat percent', 'blood total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0853084', 'cui_str': 'Increased HDL'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",54.0,0.0632106,"The BKD decreased high-density lipoprotein (HDL) cholesterol (p = 0.001) and increased fasting blood glucose (p = 0.018), whereas TAD and 2010DGA increased HDL cholesterol and did not affect blood glucose levels.","[{'ForeName': 'Seong-Ah', 'Initials': 'SA', 'LastName': 'Kim', 'Affiliation': 'Institute of Health and Environment, Seoul National University, Seoul, 08826, Korea.'}, {'ForeName': 'Sangah', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Department of Food and Nutrition, Chung-Ang University, Gyeonggi-do, 17546, Korea.'}, {'ForeName': 'Kyungho', 'Initials': 'K', 'LastName': 'Ha', 'Affiliation': 'Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, 08826, Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Hwang', 'Affiliation': 'Department of Agro-Food Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju, Korea.'}, {'ForeName': 'Young-Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Agro-Food Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju, Korea.'}, {'ForeName': 'Min-Sook', 'Initials': 'MS', 'LastName': 'Kang', 'Affiliation': 'Department of Agro-Food Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju, Korea.'}, {'ForeName': 'Hyojee', 'Initials': 'H', 'LastName': 'Joung', 'Affiliation': 'Institute of Health and Environment, Seoul National University, Seoul, 08826, Korea. hjjoung@snu.ac.kr.'}]",European journal of nutrition,['10.1007/s00394-019-02141-y']
552,31924365,Assessment of preoperative noninvasive ventilation before lung cancer surgery: The preOVNI randomized controlled study.,"OBJECTIVES


The preOVNI study was a randomized, controlled, open-label study that investigated whether preoperative noninvasive ventilation (NIV) could reduce postoperative complications after lung cancer surgery.
METHODS


Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity were included and randomly assigned to preoperative NIV (at least 7 days and 4 h/day) or no NIV. The primary endpoint was the rate of postoperative protocol-defined complications.
RESULTS


Three hundred patients were included. In the NIV group, the median NIV duration was 8 days. No difference of postoperative complication rates was evidenced: 42.6% in NIV group and 44.8% in no-NIV group (P = .75). The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08). The type of surgery (open or minimally invasive) did not impact these results after multivariable analysis.
CONCLUSIONS


No benefit was evidenced for preoperative NIV before lung cancer surgery. Further studies should determine the optimal perioperative management to decrease the rate of postoperative complications.",2020,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","['before lung cancer surgery', 'Three hundred patients were included', 'Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity', 'after lung cancer surgery']","['preoperative noninvasive ventilation', 'preoperative noninvasive ventilation (NIV']","['rate of postoperative protocol-defined complications', 'postoperative complication rates', 'postoperative complications', 'rate of pneumonia', 'median NIV duration']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",300.0,0.134838,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paleiron', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France; Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France. Electronic address: nicolas.paleiron@intradef.gouv.fr.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Grassin', 'Affiliation': 'Respiratory Disease Unit, HIA Clermont Tonnerre, Brest, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lancelin', 'Affiliation': 'Thoracic Surgery Unit, Clinique du Grand Large, Brest, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': 'Respiratory Disease Unit, HIA Percy, Clamart, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Natale', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.193']
553,31559633,Does the time-point of orthodontic space closure initiation after tooth extraction affect the incidence of gingival cleft development? A randomized controlled clinical trial.,"BACKGROUND


Gingival clefts (GCs) develop frequently during orthodontic space closure and may compromise the treatment outcome. This study assessed whether the time-point of orthodontic space closure initiation, after permanent tooth extraction, affects the incidence of GC.
METHODS


In 25 patients requiring bilateral premolar extraction because of orthodontic reasons, one premolar, chosen at random, was extracted 8 weeks before space closure initiation (""delayed movement,"" DM), whereas the contralateral premolar was extracted 1 week before (""early movement,"" EM) (""treatment group""). Presence or absence of GC after 3 and 6 months (""time-point"") was recorded and any association with various parameters (i.e., treatment group, time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure) was statistically assessed.
RESULTS


Twenty-one patients contributing with 26 jaws were finally included in the analysis. Overall, GCs were frequent after 3 (DM: 53.9%; EM: 69.2%) and 6 months (DM: 76.9%; EM: 88.5%). EM (P = 0.014) and larger space closure within the study period (P = 0.001) resulted in a significantly higher incidence of GC. Further, there was a tendency for GC development in the presence of buccal bone dehiscence (P = 0.052) and thin gingival biotype (P = 0.054). ""Fast movers"" (herein cases with a tooth movement ≥1 mm per month) developed a GC in >90% of the cases already after 3 months. ""Slow movers"" developed a GC in 25% and 70% after 3 months and final evaluation, respectively.
CONCLUSIONS


GC development is a frequent finding during orthodontic space closure and seems to occur more frequently with early tooth movement initiation and in ""fast movers.""",2020,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"['Twenty-one patients contributing with 26 jaws were finally included in the analysis', '25 patients requiring bilateral premolar extraction due to orthodontic reasons, one premolar, chosen at random']",[],"['larger space closure', 'buccal bone dehiscence', 'time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0449562', 'cui_str': 'Biotype (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",,0.157475,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Bertl', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hemma', 'Initials': 'H', 'LastName': 'Neuner', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Meran', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bertl', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Reich', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nemec', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bruckmann', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stavropoulos', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Bantleon', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}]",Journal of periodontology,['10.1002/JPER.19-0376']
554,31106922,"The impact of behavioural skills training on the knowledge, skills and well-being of front line staff in the intellectual disability sector: a clustered randomised control trial.","BACKGROUND


Staff with varying backgrounds and educational qualifications can be effectively trained to implement procedures in line with evidence-based practice. Behavioural skills training (BST) is a competency-based training model used to effectively educate a broad selection of professionals, including front line staff, in a range of work-related skills. However, BST has yet to be evaluated in a large group-based experiment.
METHODS


This study involved a parallel cluster randomised control trial. Six service sites, with a total of 54 participants, were randomised to the intervention condition using the 'coin toss' method. The intervention condition used BST to coach intellectual disability staff in reinforcement, systematic prompting, functional communication training and task analysis. Six service sites, with a total of 50 participants, were also randomised to a control condition in which generalised training in behavioural interventions was restricted. Recruited service sites were randomly assigned to the intervention condition (N = 6, n = 54) or the control condition (N = 6, n = 50) at one point in time, immediately after recruitment and before baseline testing took place. Allocations were stratified by service type (residential or day) and geographical region. One member of the research team allocated service sites using the 'coin toss' method, and another member, blind to the allocations, decided which experimental arm would receive the intervention and which would be designated as control. It was not possible to mask the intervention from participants, but they were recruited prior to randomisation.
RESULTS


Participants in the intervention condition demonstrated statistically significant improvements in their knowledge scores over the study period. Participants in the control condition showed no change or a statistically significant decrease in their knowledge scores. No statistically significant changes to well-being were observed for either group. There was clear evidence of knowledge maintenance, as well as skill acquisition and subsequent generalisation to the workplace environment, among participants in the intervention condition. Participants also evaluated the BST intervention positively.
CONCLUSIONS


Results support BST as a method for disseminating evidence-based practice to front line staff working with adults with intellectual and developmental disabilities.",2019,Participants in the control condition showed no change or a statistically significant decrease in their knowledge scores.,"['Six service sites, with a total of 54 participants', 'adults with intellectual and developmental disabilities', 'Six service sites, with a total of 50 participants', 'intellectual disability sector', 'Recruited service sites']","['BST', 'behavioural skills training', 'Behavioural skills training (BST']",['knowledge scores'],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",54.0,0.051257,Participants in the control condition showed no change or a statistically significant decrease in their knowledge scores.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gormley', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Healy', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': ""O'Regan"", 'Affiliation': 'Behavioural Department, Rehab Group, Dublin 4, Ireland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Grey', 'Affiliation': 'College of Natural and Health Sciences, Zayed University, Abu Dhabi, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bracken', 'Affiliation': 'School of Psychology, Trinity College Dublin, Dublin 2, Ireland.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12630']
555,31903800,The effect of augmented speech-language therapy delivered by telerehabilitation on poststroke aphasia-a pilot randomized controlled trial.,"OBJECTIVE


Pilot a definitive randomized controlled trial of speech-language telerehabilitation in poststroke aphasia in addition to usual care with regard to recruitment, drop-outs, and language effects.
DESIGN


Pilot single-blinded randomized controlled trial.
SETTING


Telerehabilitation delivered from tertiary rehabilitation center to participants at their home or admitted to secondary rehabilitation centers.
SUBJECTS


People with naming impairment due to aphasia following stroke.
INTERVENTION


Sixty-two participants randomly allocated to 5 hours of speech and language telerehabilitation by videoconference per week over four consecutive weeks together with usual care or usual care alone. The telerehabilitation targeted functional, expressive language.
MAIN MEASURES


Norwegian Basic Aphasia Assessment: naming (primary outcome), repetition, and auditory comprehension subtests; Verb and Sentence Test sentence production subtest and the Communicative Effectiveness Index at baseline, four weeks, and four months postrandomization. Data were analyzed by intention to treat.
RESULTS


No significant between-group differences were seen in naming or auditory comprehension in the Norwegian Basic Aphasia Assessment at four weeks and four months post randomization. The telerehabilitation group ( n  = 29) achieved a Norwegian Basic Aphasia Assessment repetition score of 8.9 points higher ( P  = 0.026) and a Verb and Sentence Test score 3 points higher ( P  = 0.002) than the control group ( n  = 27) four months postrandomization. Communicative Effectiveness Index was not significantly different between groups, but increased significantly within both groups. No adverse events were reported.
CONCLUSION


Augmented telerehabilitation via videoconference may be a viable rehabilitation model for aphasia affecting language outcomes poststroke. A definitive trial with 230 participants is needed to confirm results.",2020,No significant between-group differences were seen in naming or auditory comprehension in the Norwegian Basic Aphasia Assessment at four weeks and four months post randomization.,"['Telerehabilitation delivered from tertiary rehabilitation center to participants at their home or admitted to secondary rehabilitation centers', 'People with naming impairment due to aphasia following stroke', '230 participants']","['augmented speech-language therapy', '5\u2009hours of speech and language telerehabilitation by videoconference per week over four consecutive weeks together with usual care or usual care alone', 'speech-language telerehabilitation']","['Norwegian Basic Aphasia Assessment: naming (primary outcome), repetition, and auditory comprehension subtests; Verb and Sentence Test sentence production subtest and the Communicative Effectiveness Index', 'naming or auditory comprehension', 'adverse events', 'Communicative Effectiveness Index', 'Norwegian Basic Aphasia Assessment repetition score']","[{'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023017', 'cui_str': 'Language Therapy'}, {'cui': 'C1442467', 'cui_str': '5 hours (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.184151,No significant between-group differences were seen in naming or auditory comprehension in the Norwegian Basic Aphasia Assessment at four weeks and four months post randomization.,"[{'ForeName': 'Hege Prag', 'Initials': 'HP', 'LastName': 'Øra', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Bjørnemyr, Norway.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kirmess', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Bjørnemyr, Norway.'}, {'ForeName': 'Marian C', 'Initials': 'MC', 'LastName': 'Brady', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, Scotland.'}, {'ForeName': 'Iselin', 'Initials': 'I', 'LastName': 'Partee', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Bjørnemyr, Norway.'}, {'ForeName': 'Randi Bjor', 'Initials': 'RB', 'LastName': 'Hognestad', 'Affiliation': 'Department of Medicine, Bærum Hospital, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Beate Bertheau', 'Initials': 'BB', 'LastName': 'Johannessen', 'Affiliation': 'Department of Neurology, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Thommessen', 'Affiliation': 'Department of Neurology, Akershus University Hospital, Lorenskog, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Becker', 'Affiliation': 'Sunnaas Rehabilitation Hospital, Bjørnemyr, Norway.'}]",Clinical rehabilitation,['10.1177/0269215519896616']
556,31539053,Energy Availability Is Associated With Luteinizing Hormone Pulse Frequency and Induction of Luteal Phase Defects.,"OBJECTIVE


Determine the interrelations between reductions in energy availability (EA), luteinizing hormone (LH) pulse frequency, and the induction of menstrual disturbances in previously sedentary, ovulatory women.
METHODS


Secondary analysis of a randomized controlled trial consisting of a 3-month controlled diet and supervised exercise program. EA was calculated daily by measured energy intake (kcal) and exercise energy expenditure (kcal) normalized to fat-free mass (kg) and averaged during baseline and each of 3 intervention menstrual cycles. Blood samples were obtained every 10 minutes for 24 hours in the early follicular phase before the intervention and after 3 months of diet and exercise (n = 14). LH pulse dynamics were assessed by Cluster. Linear mixed models determined whether EA predicts LH pulse frequency and LH pulse frequency predicts luteal phase defects (LPDs).
RESULTS


Subjects were 20 ± 1 years old, 165.1 ± 1.4 cm tall, and weighed 58.9 ± 1.5 kg. LH pulse frequency decreased from 0.82 ± 0.06 pulses/h to 0.63 ± 0.09 pulses/h (P = 0.048) as a result of the intervention which produced modest (-3.2 ± 0.6 kg) weight loss. EA, averaged across a menstrual cycle, predicted LH pulse frequency (P = 0.003) such that a single-unit decrease in EA was associated with a 0.017 pulses/h decrease in LH pulse frequency. LH pulse frequency in cycles with LPDs was 49% of that observed in cycles with no menstrual disturbances and for every 0.1-unit decrease in LH pulse frequency, the odds of having an LPD were 22× greater than having an optimal ovulatory cycle (P = 0.01).
CONCLUSIONS


Modest reductions in EA over a prolonged period are associated with decreased LH pulse frequency and the induction of menstrual disturbances.",2020,LH pulse frequency decreased from 0.82±0.06pulses,"['Subjects were 20±1yrs old 165.1±1.4cm tall and weighed 58.9±1.5kg', 'previously sedentary, ovulatory women']",['controlled diet and supervised exercise program'],"['energy intake (kcal) and exercise energy expenditure (kcal) normalized to fat-free mass (kg', 'EA predicts LH pulse frequency and LH pulse frequency predicts luteal phase defects (LPDs', 'energy availability (EA), LH pulse frequency, and the induction of menstrual disturbances', 'LH pulse dynamics', 'LH pulse frequency']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0404576', 'cui_str': 'Luteal phase defect (disorder)'}, {'cui': 'C0025345', 'cui_str': 'Menstruation Disorders'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",,0.0510295,LH pulse frequency decreased from 0.82±0.06pulses,"[{'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Koltun', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'De Souza', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Scheid', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Nancy I', 'Initials': 'NI', 'LastName': 'Williams', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz030']
557,31828841,Randomised trial showed that rapid rehydration of severely malnourished children with dehydrating diarrhoea was as safe and effective as slow rehydration.,"AIM


This study evaluated the effectiveness and safety of rapid and slow rehydration in children aged 6-60 months with dehydrating diarrhoea and severe malnutrition.
METHODS


A randomised controlled trial was conducted from July 2011 to March 2014 at the International Centre for Diarrhoeal Disease Research Bangladesh. We included children with weight for age and, or, weight for length Z-scores of less than -3 or with bipedal oedema and acute diarrhoea with severe dehydration. The children received intravenous fluid at different rates: 105 rapidly over six hours and 103 slowly over the 12 hours recommended by the World Health Organization.
RESULTS


All the children were successfully rehydrated. The admittance weights were similar for the slow and rapid groups: 8.4 kg and 8.3 kg. After 24 hours, the mean percentage weight gain was 8.5% and 9.0%, respectively. This confirmed that most of the children had been suffering from severe dehydration on admission. The respective proportions of children who received unscheduled intravenous fluid were 18% and 17%. None developed fluid overload or heart failure and most recovered normal renal function after rehydration.
CONCLUSION


Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.",2020,"CONCLUSION


Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.","['July 2011 to March 2014 at the International Centre for Diarrhoeal Disease Research Bangladesh', 'children aged 6-60\xa0months with dehydrating diarrhoea and severe malnutrition', 'children with weight for age and, or, weight for length Z-scores of less than -3 or with bipedal oedema and acute diarrhoea with severe dehydration', 'severely malnourished children with dehydrating diarrhoea']","['rapid and slow rehydration', 'rapid rehydration']","['admittance weights', 'mean percentage weight gain', 'fluid overload or heart failure', 'normal renal function']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0035168'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea (disorder)'}, {'cui': 'C3472181', 'cui_str': 'Severe dehydration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0034997', 'cui_str': 'Rehydration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424660', 'cui_str': 'Percentage weight gain (observable entity)'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}]",105.0,0.33823,"CONCLUSION


Rapid rehydration saved time, was as safe as slow rehydration and was a better option for dehydrating diarrhoea and severe malnutrition.","[{'ForeName': 'Nur H', 'Initials': 'NH', 'LastName': 'Alam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ashraf', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Nishat', 'Initials': 'N', 'LastName': 'Jahan', 'Affiliation': 'Department of Pharmacy, University of Asia Pacific, Dhaka, Bangladesh.'}, {'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Gyr', 'Affiliation': 'Faculty of Medicine, University of Basel, Basel, Switzerland.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15134']
558,31900579,Time course of tolerance to adverse effects associated with the ingestion of a moderate dose of caffeine.,"PURPOSE


This study aimed to identify and describe the time course of tolerance to the most common caffeine-induced side effects.
METHODS


Eleven participants took part in a crossover, double-blind placebo-controlled experimental design. In one phase, participants ingested 3 mg/kg/day of caffeine for 20 days, while in another phase, they ingested a placebo. Resting heart rate and blood pressure were measured three times per week during each 20-day phase and a quantitative survey was used to categorise the magnitude of side effects.
RESULTS


In the pairwise comparison with the placebo, the ingestion of caffeine increased systolic (+ 7.8 ± 10.1%, P < 0.05) and diastolic blood pressure (+ 6.4 ± 12.9% P < 0.05) for the first 8 days of ingestion, but then this effect became attenuated for both outcomes (on day 20, - 1.1 ± 4.3% and + 0.9 ± 9.6%, respectively). The ingestion of caffeine did not affect heart rate at any time point. Caffeine increased the feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points in the treatment (P < 0.05) and they did not disappear after 20 days of ingestion.
CONCLUSIONS


The daily intake of 3 mg/kg of caffeine induced a meaningful elevation in arterial blood pressure that disappeared after 8 days. However, other caffeine-induced effects such as increased nervousness and vigour, irritability, insomnia and diuresis remained after 20 days of consecutive caffeine ingestion. Although there was clear tolerance to the effect of caffeine on blood pressure, the persistence of other side effects suggests the inconvenience of maintaining a chronic caffeine intake, at least at the dose of 3 mg/kg/day.",2020,"Caffeine increased the feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points in the treatment (P < 0.05) and they did not disappear after 20 days of ingestion.
","['Eleven participants took part in a crossover, double-blind']","['placebo', 'Caffeine', 'caffeine']","['feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points', 'heart rate', 'Resting heart rate and blood pressure', 'systolic', 'nervousness and vigour, irritability, insomnia and diuresis', 'arterial blood pressure', 'diastolic blood pressure', 'blood pressure']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",11.0,0.114515,"Caffeine increased the feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points in the treatment (P < 0.05) and they did not disappear after 20 days of ingestion.
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Salinero', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Brito de Souza', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ordovás', 'Affiliation': 'USDA ARS, Human Nutrition Research Center On Aging At Tufts University, Boston, MA, 02111, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, C/Camino del Molino, s/n, 28943, Fuenlabrada, Spain. juan.delcoso@urjc.es.'}]",European journal of nutrition,['10.1007/s00394-019-02167-2']
559,31899803,Promising results from an implemented treatment model for paediatric obesity.,"AIM


To investigate the implementation of a plan of action for treatment of childhood obesity, and the effect after 2 years of treatment.
METHODS


Children aged 6-12.9 years who started obesity treatment between 2008 and 2015 in a paediatric clinic in Stockholm County were included. The treatment model included staff education and support and group activities for parents and children separately followed by individual sessions to a multidisciplinary team. The main outcome was change in body mass index standard deviation score (BMI SDS), in comparison to a matched control group.
RESULTS


In the intervention group, 1334 children (52% boys) with an average age of 9.3 years and BMI SDS of 2.7 and 3012 children in the control group were included. The intervention group decreased their BMI SDS more after two years compared with the control group, (-0.31 vs -0.23, P < .001). Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all P < .001) had greater decreases in BMI SDS after 2 years. Sex did not affect the outcome.
CONCLUSION


Even though the treatment in the control group was effective, the implementation of the action plan yielded a better treatment response compared with the control group.",2020,Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all p<0.001) had greater decreases in BMI SDS after two years.,"['paediatric obesity', '1,334 children (52% boys) with an average age of 9.3 years and BMI SDS of 2.7 and 3,012 children in the control group were included', 'Children aged 6-12.9 years who started obesity treatment between 2008-2015 in a paediatric clinic in Stockholm County were included']",[],"['BMI SDS', 'body mass index standard deviation score (BMI SDS']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1334.0,0.0355141,Younger age and higher BMI SDS at treatment initiation and families that completed the group sessions (all p<0.001) had greater decreases in BMI SDS after two years.,"[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hagman', 'Affiliation': 'Division of Paediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bohlin', 'Affiliation': ""Department of Women's and Children's Health, Södertälje Hospital, Sodertalje, Sweden.""}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Klaesson', 'Affiliation': ""Department of Women's and Children's Health, Södertälje Hospital, Sodertalje, Sweden.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ejderhamn', 'Affiliation': ""Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Danielsson', 'Affiliation': 'Division of Paediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15158']
560,31917748,Brief Report: Accuracy in Self-Report of Viral Suppression Among HIV-Positive Men With HIV-Negative Male Partners.,"BACKGROUND


Among men who have sex with men, there is now clear evidence that the risk of HIV transmission through condomless sex when the HIV-positive partner is virally suppressed is effectively zero. However, an understanding of the accuracy of reporting of viral load among serodiscordant same-sex male couples is missing from the literature.
SETTING


This analysis uses data from the baseline sample of Stronger Together, a randomized controlled efficacy trial of an innovative dyadic intervention to enhance antiretroviral therapy adherence for HIV serodiscordant male couples in 3 US cities (Atlanta, Boston, and Chicago).
METHODS


Biomarker-confirmed and self-reported measures of viral load were used to assess the accuracy of self-report of viral suppression. In this descriptive analysis, the percentage of men who inaccurately reported being virally suppressed is compared across demographic, relationship, and HIV care characteristics.
RESULTS


Results confirm those of other recent studies that have shown relatively high levels of inaccuracy in reporting of viral suppression. Although 72.5% of men could accurately report their viral load status, 20% reported that they were virally suppressed when they did not have a biomarker-confirmed measure of viral suppression.
CONCLUSION


These results highlight the need to provide interventions to men who have sex with men living with HIV to support access to care and ensure current knowledge of viral load and to continue to support primary prevention of HIV through condom use and pre-exposure prophylaxis. For couples, particularly serodiscordant male couples, interventions that can teach the couple how to collaborate to achieve and maintain viral suppression for the positive partner are an urgent and pragmatic programmatic priority that can equip couples with the knowledge required to correctly implement U = U strategies.",2020,"Although 72.5% of men could accurately report their viral load status, 20% reported that they were virally suppressed when they did not have a biomarker confirmed measure of viral suppression.
","['men who have sex with men (MSM', 'HIV-positive men with HIV-negative male partners', 'HIV serodiscordant male couples in three US cities (Atlanta, Boston and Chicago']",['innovative dyadic intervention'],['accuracy of self-report of viral suppression'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",,0.0812644,"Although 72.5% of men could accurately report their viral load status, 20% reported that they were virally suppressed when they did not have a biomarker confirmed measure of viral suppression.
","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Department of Systems, Population and Leadership, The Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bratcher', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, CA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'Center for Health Equity Research, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Hoehnle', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002240']
561,31631501,Early Switch From Tacrolimus to Everolimus After Liver Transplantation: Outcomes at 2 Years.,"The observational CERTITUDE study follows liver transplant patients who completed the SIMCER trial. SIMCER randomized patients at month 1 after transplant to everolimus (EVR) with stepwise tacrolimus (TAC) withdrawal or to standard TAC, both with basiliximab induction and mycophenolic acid ± steroids. After completing SIMCER at 6 months after transplant, 65 EVR-treated patients and 78 TAC-treated patients entered CERTITUDE. At month 24 after transplant, 34/65 (52.3%) EVR-treated patients remained calcineurin inhibitor (CNI) free. Mean estimated glomerular filtration rate (eGFR) was significantly higher with EVR versus TAC during months 3-12. At month 24, eGFR values were 83.6 versus 75.3 mL/minute/1.73 m 2  , respectively (P = 0.90) and adjusted mean change in eGFR from randomization was -8.0 versus -13.5 mL/minute/1.73 m 2  (P = 0.15). At month 24, 45.9%, 31.1%, and 23.0% of EVR-treated patients had chronic kidney disease stages 1, 2, and 3, respectively, versus 25.7%, 45.7%, and 28.6% of TAC-treated patients (P = 0.05). Treated biopsy-proven acute rejection affected 4 EVR-treated patients and 2 TAC patients during months 6-24. Adverse events led to study discontinuation in 15.4% and 7.7% of EVR-treated and TAC-treated patients, respectively. Grade 3 or 4 hematological events were rare in both groups. A CNI-free EVR-based maintenance regimen appears feasible in approximately half of liver transplant patients. It preserves renal function effectively with good efficacy without compromising safety or hematological tolerance.",2019,"Mean estimated GFR was significantly higher with everolimus versus tacrolimus during months 3-12; at month 24, values were 83.6 versus 75.3mL/min/1.73m 2  , respectively (p=0.089) and adjusted mean change in estimated GFR from randomization was -8.0 versus -13.5 mL/min/1.73m 2  (p=0.15).","['after liver transplantation', 'liver transplant patients who completed the SIMCER trial', 'liver transplant patients']","['CNI-free everolimus-based maintenance regimen', 'tacrolimus', 'tacrolimus to everolimus', 'everolimus versus tacrolimus', 'everolimus with stepwise tacrolimus withdrawal or to standard tacrolimus, both with basiliximab induction, mycophenolic acid ± steroids']","['safety or hematological tolerance', 'Mean estimated GFR', 'Grade 3 or 4 hematological events']","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",65.0,0.0229432,"Mean estimated GFR was significantly higher with everolimus versus tacrolimus during months 3-12; at month 24, values were 83.6 versus 75.3mL/min/1.73m 2  , respectively (p=0.089) and adjusted mean change in estimated GFR from randomization was -8.0 versus -13.5 mL/min/1.73m 2  (p=0.15).","[{'ForeName': 'Faouzi', 'Initials': 'F', 'LastName': 'Saliba', 'Affiliation': 'Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duvoux', 'Affiliation': 'Hôpital Henri Mondor, AP-HP, Créteil, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Dharancy', 'Affiliation': 'CHRU de Lille, Lille, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dumortier', 'Affiliation': 'Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Yvon', 'Initials': 'Y', 'LastName': 'Calmus', 'Affiliation': 'Hôpital Pitié Salpêtrière, AP-HP, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': ""Hôpital l'Archet 2, Nice, France.""}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Hôpital Rangueil, Toulouse, France.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Salamé', 'Affiliation': 'Hôpital Trousseau, Chambray les Tours, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Neau-Cransac', 'Affiliation': 'Hôpital Haut Levèque, Bordeaux, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vanlemmens', 'Affiliation': 'Hôpital Jean Minjoz, Besançon, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Durand', 'Affiliation': 'Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Pageaux', 'Affiliation': 'Hôpital Saint Eloi, Montpellier, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Leroy', 'Affiliation': 'Hôpital Albert Michallon, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hardwigsen', 'Affiliation': 'Hôpital la Timone, Marseille, France.'}, {'ForeName': 'Hakam', 'Initials': 'H', 'LastName': 'Gharbi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Masson', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Tindel', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Conti', 'Affiliation': 'Hôpital Pitié Salpêtrière, AP-HP, Paris, France.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25664']
562,31916797,A pilot randomized clinical trial of a lethal means safety intervention for young adults with firearm familiarity at risk for suicide.,"OBJECTIVE


Firearms are the most common method of suicide in the United States. The provision of firearm-specific lethal means safety interventions is a best practice for the prevention and management of suicide risk. However, few data exist to inform firearm-specific lethal means safety interventions. This study tested four different lethal means safety interventions that varied on two dimensions salient to health behavior change (i.e., fear appeals and emphasis on temporariness).
METHOD


Overall, 96 college-enrolled young adults with a history of suicidal ideation and current firearm familiarity (i.e., firearm ownership, access, and/or a desire/intention to obtain a firearm) were randomized to one of four different firearm-specific lethal means safety interventions occurring in the context of the Safety Planning Intervention. Assessments occurred at preintervention, postintervention, and 1-month follow-up.
RESULTS


Participants who received the firearm-specific lethal means safety intervention that deemphasized fear and emphasized temporariness reported significantly greater intentions to adhere to clinician recommendations to limit their access to firearms for safety purposes compared to individuals randomized to the other groups (Intervention × Time),  F (6, 184) = 2.300,  p  = .036, corresponding to a medium effect size (η p ² = .070). Across groups, 35.4% of participants reported an increase in engagement in firearm safety thoughts/behaviors from preintervention to 1-month follow-up; there were no significant group differences. All four intervention approaches were rated as similarly highly acceptable.
CONCLUSIONS


Findings underscore the potential importance of deemphasizing fear and emphasizing temporariness in firearm-specific lethal means safety interventions. Future studies leveraging these pilot data are needed to replicate and extend findings. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,The provision of firearm-specific lethal means safety interventions is a best practice for the prevention and management of suicide risk.,"['young adults with firearm familiarity at risk for suicide', '96 college-enrolled young adults with a history of suicidal ideation and current firearm familiarity (i.e., firearm ownership, access, and/or a desire/intention to obtain a firearm']","['lethal means safety intervention', 'firearm-specific lethal means safety interventions occurring in the context of the Safety Planning Intervention']",['engagement in firearm safety thoughts/behaviors'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",2020.0,0.0451071,The provision of firearm-specific lethal means safety interventions is a best practice for the prevention and management of suicide risk.,"[{'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychology, Florida State University.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Hom', 'Affiliation': 'Department of Psychology, Florida State University.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Sachs-Ericsson', 'Affiliation': 'Department of Psychology, Florida State University.'}, {'ForeName': 'Austin J', 'Initials': 'AJ', 'LastName': 'Gallyer', 'Affiliation': 'Department of Psychology, Florida State University.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Joiner', 'Affiliation': 'Department of Psychology, Florida State University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000481']
563,31919514,"Acute Hyperenergetic, High-Fat Feeding Increases Circulating FGF21, LECT2, and Fetuin-A in Healthy Men.","BACKGROUND


Hepatokines such as fibroblast growth factor 21 (FGF21), leukocyte cell-derived chemotaxin 2 (LECT2), fetuin-A, fetuin-B, and selenoprotein P (SeP) are liver-derived proteins that are modulated by chronic energy status and metabolic disease. Emerging data from rodent and cell models indicate that hepatokines may be sensitive to acute nutritional manipulation; however, data in humans are lacking.
OBJECTIVE


The aim was to investigate the influence of hyperenergetic, high-fat feeding on circulating hepatokine concentrations, including the time course of responses.
METHODS


In a randomized, crossover design, 12 healthy men [mean ± SD: age, 24 ± 4 y; BMI (kg/m2), 24.1 ± 1.5] consumed a 7-d hyperenergetic, high-fat diet [HE-HFD; +50% energy, 65% total energy as fat (32% saturated, 26% monounsaturated, 8% polyunsaturated)] and control diet (36% total energy as fat), separated by 3 wk. Whole-body insulin sensitivity was assessed before and after each diet using oral-glucose-tolerance tests. Fasting plasma concentrations of FGF21 (primary outcome), LECT2, fetuin-A, fetuin-B, SeP, and related metabolites were measured after 1, 3, and 7 d of each diet. Hepatokine responses were analyzed using 2-factor repeated-measures ANOVA and subsequent pairwise comparisons.
RESULTS


Compared with the control, the HE-HFD increased circulating FGF21 at 1 d (105%) and 3 d (121%; P ≤ 0.040), LECT2 at 3 d (17%) and 7 d (32%; P ≤ 0.004), and fetuin-A at 7 d (7%; P = 0.028). Plasma fetuin-B and SeP did not respond to the HE-HFD. Whole-body insulin sensitivity was reduced after the HE-HFD by 31% (P = 0.021).
CONCLUSIONS


Acute high-fat overfeeding augments circulating concentrations of FGF21, LECT2, and fetuin-A in healthy men. Notably, the time course of response varies between proteins and is transient for FGF21. These findings provide further insight into the nutritional regulation of hepatokines in humans and their interaction with metabolic homeostasis. This study was registered at clinicaltrials.gov as NCT03369145.",2020,"Whole-body insulin sensitivity was reduced after the HE-HFD by 31% (P = 0.021).
","['12 healthy men [mean\xa0±\xa0SD: age, 24\xa0±\xa04', 'Healthy Men', 'healthy men']","['monounsaturated, 8% polyunsaturated)] and control diet']","['Hepatokine responses', 'Plasma fetuin-B and SeP', 'Whole-body insulin sensitivity', 'Fasting plasma concentrations of FGF21 (primary outcome), LECT2, fetuin-A, fetuin-B, SeP, and related metabolites', 'HE-HFD increased circulating FGF21']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3203083', 'cui_str': 'Fetuin-Like Protein IRL685'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0051477', 'cui_str': 'AHSG Protein'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",12.0,0.0324401,"Whole-body insulin sensitivity was reduced after the HE-HFD by 31% (P = 0.021).
","[{'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'National Institute for Health Research(NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester National Health Service (NHS) Trust and the University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'National Institute for Health Research(NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester National Health Service (NHS) Trust and the University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Takamura', 'Affiliation': 'Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takayama', 'Affiliation': 'Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Brittain', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Crawford', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Siôn A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Varela-Mato', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Woods', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Hulston', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Guruprasad P', 'Initials': 'GP', 'LastName': 'Aithal', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxz333']
564,31919583,Modest improvement in CVD risk markers in older adults following quinoa (Chenopodium quinoa Willd.) consumption: a randomized-controlled crossover study with a novel food product.,"PURPOSE


To investigate the effect of consuming quinoa biscuits on markers of CVD risk over 4 weeks in free-living older adults.
METHODS


A randomized-controlled, double-blind crossover trial was conducted in which consenting healthy adults aged 50-75 years (n = 40) consumed 15 g quinoa biscuits (60 g quinoa flour/100 g) or control iso-energetic biscuits (made using wheat flour) daily for 28 consecutive days (4 weeks), in addition to their normal diet. Following a 6-week washout, participants consumed the alternate biscuit for a final 4 weeks. Anthropometry and fasted blood samples were obtained before and after each intervention period.
RESULTS


At the beginning of the trial, mean ± SD total cholesterol concentrations were 6.02 ± 1.22 mmol/L (3.7-9.2 mmol/L); 33 participants (82.5%) had high cholesterol (> 5 mmol/L). No participants were lost to follow-up and there were no changes in habitual dietary intakes or levels of physical activity between each 4-week intervention period. Significantly greater decreases in total and LDL cholesterol concentrations (- 0.30 ± 0.58 and - 0.25 ± 0.38 mmol/L, respectively), TC: HDL ratio (- 0.11 ± 0.30), weight (- 0.61 ± 0.89 kg) and BMI (- 0.22 ± 0.34 kg/m 2 ) were apparent following consumption of the quinoa versus control biscuits (all P < 0.05). Changes in triglycerides, HDL cholesterol, or PUFA or CRP concentrations were not significant between treatment groups.
CONCLUSION


Consumption of novel quinoa biscuits produced small, but favorable changes in body weight, BMI, and circulating cholesterol concentrations, all of which may contribute to lowered CVD risk in older adults.",2020,No participants were lost to follow-up and there were no changes in habitual dietary intakes or levels of physical activity between each 4-week intervention period.,"['older adults following quinoa (Chenopodium quinoa Willd', 'consenting healthy adults aged 50-75\xa0years (n\u2009=\u200940', 'free-living older adults', 'older adults']","['consumed 15\xa0g quinoa biscuits (60\xa0g quinoa flour/100\xa0g) or control iso-energetic biscuits (made using wheat flour', 'consuming quinoa biscuits']","['BMI', 'TC: HDL ratio', 'weight', 'CVD risk markers', 'habitual dietary intakes or levels of physical activity', 'total and LDL cholesterol concentrations', 'mean\u2009±\u2009SD total cholesterol concentrations', 'CVD risk', 'triglycerides, HDL cholesterol, or PUFA or CRP concentrations', 'body weight, BMI, and circulating cholesterol concentrations']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1504609', 'cui_str': 'Quinoa'}, {'cui': 'C0453354', 'cui_str': 'Chenopodium quinoa'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1504609', 'cui_str': 'Quinoa'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour (substance)'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",33.0,0.0665714,No participants were lost to follow-up and there were no changes in habitual dietary intakes or levels of physical activity between each 4-week intervention period.,"[{'ForeName': 'L Kirsty', 'Initials': 'LK', 'LastName': 'Pourshahidi', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, BT52 1SA, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Caballero', 'Affiliation': 'Regional Centre for Studies in Food and Health (CREAS), Avenida Universidad N°330, Valparaiso, Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Osses', 'Affiliation': 'Regional Centre for Studies in Food and Health (CREAS), Avenida Universidad N°330, Valparaiso, Chile.'}, {'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Hyland', 'Affiliation': 'School of Biomedical Sciences, Ulster University, Coleraine, BT52 1SA, UK.'}, {'ForeName': 'Nigel G', 'Initials': 'NG', 'LastName': 'Ternan', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, BT52 1SA, UK.'}, {'ForeName': 'Chris I R', 'Initials': 'CIR', 'LastName': 'Gill', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, BT52 1SA, UK. c.gill@ulster.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-019-02169-0']
565,31906840,"Vitamin D and Calcium Supplement Attenuate Bone Loss among HIVInfected Patients Receiving Tenofovir Disoproxil Fumarate/Emtricitabine/ Efavirenz: An Open-Label, Randomized Controlled Trial.","BACKGROUND


Antiretroviral therapy (ART), especially with tenofovir disoproxil fumarate (TDF), has been associated with accelerated bone turnover and leads to significant bone loss.
OBJECTIVE


We aimed to determine the effect of vitamin D2 and calcium on bone mineral density (BMD) in HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV).
METHODS


A prospective, open-label, randomized controlled study was conducted. Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV. The study group received supplementation with vitamin D2 and calcium carbonate, whereas the control group was administered only ART. The primary outcome was the percentage change in total hip BMD at week 24 compared with baseline.
RESULTS


A total of 18 patients were randomized (9 in each group). The mean (standard deviation; SD) total hip BMD significantly decreased from baseline in both groups, from 0.96 (0.14) g/cm2 to 0.93 (0.13) g/cm2 in the study group (p = 0.006) and from 0.87 (0.11) g/cm2 to 0.84 (0.11) g/cm2 in the control group (p = 0.004). The mean (SD) lumbar spine BMD significantly decreased from baseline in both groups, from 1.00 (0.13) g/cm2 to 0.97 (0.13) g/cm2 (p = 0.004) in the study group and from 0.90 (0.09) g/cm3 to 0.86 (0.08) g/cm2 in the control group (p = 0.006). At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042). However, there were no significant differences in the percentage change of total hip, lumbar spine, and femoral neck BMD between both groups. No adverse events were reported. In conclusion, as early as 24 weeks after TDF initiation, a significant decline in BMD was detected.
CONCLUSION


Vitamin D2 and calcium supplements should be considered for HIV-infected patients receiving TDF/FTC/EFV in a resource-limited setting where there are limited ART options (Clinicaltrials. gov NCT0287643).",2020,"At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042).","['18 patients', 'HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV', 'Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV', 'HIV-infected Patients Receiving']","['tenofovir disoproxil fumarate (TDF', 'Vitamin D and Calcium Supplement', 'Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz', 'supplementation with vitamin D2 and calcium carbonate', 'vitamin D2 and calcium', 'Vitamin D2 and calcium supplements']","['BMD', 'mean (standard deviation; SD) total hip BMD', 'mean (SD) lumbar spine BMD', 'percentage change of total hip, lumbar spine, and femoral neck BMD', 'bone mineral density (BMD', 'percentage change in total hip BMD', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement (substance)'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0746104,"At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042).","[{'ForeName': 'Patawee', 'Initials': 'P', 'LastName': 'Boontanondha', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Hataikarn', 'Initials': 'H', 'LastName': 'Nimitphong', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Suchawadee', 'Initials': 'S', 'LastName': 'Musikarat', 'Affiliation': 'Department of Diagnostic and Therapeutic Radiology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Aschara', 'Initials': 'A', 'LastName': 'Ragkho', 'Affiliation': 'Department of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Sasisopin', 'Initials': 'S', 'LastName': 'Kiertiburanakul', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.'}]",Current HIV research,['10.2174/1570162X18666200106150806']
566,31280997,Effect of N-acetylcysteine on liver and kidney function tests after surgical bypass in obstructive jaundice: A randomized controlled trial.,"BACKGROUND


It has been shown that N-acetylcysteine may be useful in correcting postoperative hepatic and renal function in many pathological conditions. The present study aimed to examine the effect of N-acetylcysteine on liver and kidney function tests after surgical bypass in patients with obstructive jaundice.
METHODS


& Materials: A total of 30 patients with obstructive jaundice who were candidates for bypass surgery were enrolled in this randomized clinical trial. In the case group, intravenous N-acetylcysteine (200 mg/kg per hour in the first 8 h, followed by 100 mg/kg per hour for another 16 h, the same dose for another 24 h) was administered postoperatively. Liver and renal function tests (serum AST, ALT, ALP, GGT, bilirubin, and creatinine) were compared between two groups, as well as duration of hospitalization and ICU stay.
RESULTS


Postoperatively, decrease in mean serum AST (p = 0.01), ALT (p = 0.02), ALP (p = 0.01), GGT (p = 0.04) and bilirubin (total, p = 0.02, direct, p = 0.01) levels compared to the preoperative values was significantly more among cases compared to those in controls. Changes in serum creatinine, however, did not differ significantly between two groups (p = 0.18). Hospital and ICU stays were also not different between two study groups (p = 0.27 and p = 0.94 respectively).
CONCLUSION


On the basis of our findings, intravenous N-acetylcysteine in patients with obstructive jaundice could significantly preserve liver function after bypass surgery. Effect of this medication on renal function; however, was not statistically significant.
TRIAL REGISTRATION


Iranian Registry of Clinical Trial: IRCT2016041016473N7.",2020,"Postoperatively, decrease in mean serum AST (p = 0.01), ALT (p = 0.02), ALP (p = 0.01), GGT (p = 0.04) and bilirubin (total, p = 0.02, direct, p = 0.01) levels compared to the preoperative values was significantly more among cases compared to those in controls.","['30 patients with obstructive jaundice who were candidates for bypass surgery', 'patients with obstructive jaundice', ' Materials', 'liver and kidney function tests after surgical bypass in obstructive jaundice']","['intravenous N-acetylcysteine', 'N-acetylcysteine']","['bilirubin', 'serum creatinine', 'mean serum AST', 'duration of hospitalization and ICU stay', 'liver and kidney function tests', 'ALP', 'liver function', 'Hospital and ICU stays', 'Liver and renal function tests (serum AST, ALT, ALP, GGT, bilirubin, and creatinine', 'renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022662', 'cui_str': 'Kidney Function Tests'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022662', 'cui_str': 'Kidney Function Tests'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",30.0,0.0258597,"Postoperatively, decrease in mean serum AST (p = 0.01), ALT (p = 0.02), ALP (p = 0.01), GGT (p = 0.04) and bilirubin (total, p = 0.02, direct, p = 0.01) levels compared to the preoperative values was significantly more among cases compared to those in controls.","[{'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Kakaei', 'Affiliation': 'Department of General Surgery, Tabriz University of Medical Sciences, Tabriz, Iran; Section of Visceral Transplantation, Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Fasihi', 'Affiliation': 'Department of General Surgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Hashemzadeh', 'Affiliation': 'Department of General Surgery, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Cardiothoracic Surgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Zarrintan', 'Affiliation': 'Division of Vascular & Endovascular Surgery, Department of General & Vascular Surgery, Shohada-Tajrish Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: s.zarrintan@yahoo.com.'}, {'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Beheshtirouy', 'Affiliation': 'Department of Cardiothoracic Surgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Touraj', 'Initials': 'T', 'LastName': 'Asvadi-Kermani', 'Affiliation': 'Department of General Surgery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kowsar', 'Initials': 'K', 'LastName': 'Tarvirdizadeh', 'Affiliation': 'Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyfollah', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'Department of General Surgery, Imam Khomeini Hospital, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Sanei', 'Affiliation': 'Section of Kidney Transplantation, School of Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Asian journal of surgery,['10.1016/j.asjsur.2019.05.009']
567,31895298,"Lactalbumin, Not Collagen, Augments Muscle Protein Synthesis with Aerobic Exercise.","INTRODUCTION


Protein ingestion and the ensuing hyperaminoacidemia stimulates skeletal muscle protein synthesis in the postexercise period. This response facilitates muscle remodeling, which is important during intensified training. The aim of this study was to determine whether supplementation with α-lactalbumin (LA), with high leucine and tryptophan contents, would improve responses to short periods of intensified aerobic training compared with supplementation with an isonitrogenous quantity of collagen peptides (CP).
METHODS


Endurance-trained participants (5 male, 6 female, 24 ± 4 yr, V˙O2 = 53.2 ± 9.1 mL·kg·min, peak power output = 320 ± 48 W; means ± SD) consumed a controlled diet (1.0 g·kg·d protein) and refrained from habitual training for 11 d while taking part in this double-blind randomized, crossover trial. The two intervention phases, which consisted of brief intensified training (4 × 4-min cycling intervals at 70% of peak power output on 3 consecutive days) combined with the ingestion of LA or CP supplements after exercise (20 g) and before sleep (40 g), were separated by 4 d of washout without protein supplementation (i.e., the control phase). In response to each phase, myofibrillar (MyoPS), sarcoplasmic protein synthesis (SarcPS) rates (via H2O ingestion) and parameters of sleep quality were measured.
RESULTS


LA ingestion increased plasma leucine (P < 0.001) and tryptophan concentrations (P < 0.001) relative to CP. Intensified training increased MyoPS and SarcPS above the washout phase in LA- and CP-supplemented phases (P < 0.01), with increases being 13% ± 5% and 5% ± 7% greater with LA than CP for MyoPS (P < 0.01) and SarcPS, respectively (P < 0.01).
CONCLUSIONS


Despite an isonitrogenous diet, protein synthesis was enhanced to a greater extent when trained participants consumed LA compared with CP during intensified aerobic training, suggesting that protein quality is an important consideration for endurance-trained athletes aiming to augment adaption to exercise training.",2020,LA ingestion increased plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP.,"['Endurance trained participants (5M, 6F, 24 ± 4 years, V[Combining']","['brief intensified training (4×4-min cycling intervals at 70% of PPO on 3 consecutive days) combined with the ingestion of LA or CP supplements post-exercise', 'supplementation with α-Lactalbumin (LA']","['myofibrillar (MyoPS), sarcoplasmic protein synthesis (SarcPS) rates (via H2O ingestion) and parameters of sleep quality', 'plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP', 'MyoPS and SarcPS']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0022912', 'cui_str': 'Lactalbumin'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",320.0,0.0426972,LA ingestion increased plasma leucine (p<0.001) and tryptophan concentrations (p<0.001) relative to CP.,"[{'ForeName': 'Sara Y', 'Initials': 'SY', 'LastName': 'Oikawa', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Macinnis', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Tripp', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'McGlory', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Baker', 'Affiliation': 'Department of Neurology, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, CANADA.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, Ontario, CANADA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002253']
568,31812918,Exploring the acceptability and feasibility of patient-initiated follow-up for women treated for stage I endometrial cancer.,"PURPOSE


There is a strong shift away from hospital-based approaches to follow-up after active treatment for cancer with supported self-management being promoted as an approach to long term recovery. We aimed to determine the acceptability and feasibility of patient-initiated follow-up (PIFU), supported by a self-management approach, for patients treated for Stage I endometrial cancer.
METHODS


A mixed methods study was undertaken. Participants were asked to forego hospital outpatient follow-up appointments, supported by a self-management approach. Outcome measures included satisfaction with information and service, psychological morbidity, quality of life and preferences for follow-up. Qualitative interviews were carried out with study participants to determine their views on follow-up in general and PIFU in particular.
RESULTS


We recruited 17 patients. High levels of satisfaction were evident with no physical or psychological detriment. Self-management was a favoured option. Participants questioned the value of hospital follow-up and were willing to engage in self-management if they knew who to contact if they had a problem and were aware of the signs and symptoms of recurrence. However, uptake to the study was low and further work is needed to explore if recruitment to a randomised controlled trial (RCT) is a viable option.
CONCLUSIONS


Alternative approaches to hospital-based follow-up need to demonstrate that patients feel supported, knowing what symptoms to report and to whom. This study shows acceptability of a supported self-management approach but raises some concerns about the feasibility of recruitment to a future RCT.",2020,"Qualitative interviews were carried out with study participants to determine their views on follow-up in general and PIFU in particular.
","['17 patients', 'patients treated for Stage I endometrial cancer', 'women treated for stage I endometrial cancer']",['patient-initiated follow-up (PIFU'],"['High levels of satisfaction', 'satisfaction with information and service, psychological morbidity, quality of life and preferences for follow-up']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0034380'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.0757123,"Qualitative interviews were carried out with study participants to determine their views on follow-up in general and PIFU in particular.
","[{'ForeName': 'Kinta', 'Initials': 'K', 'LastName': 'Beaver', 'Affiliation': 'School of Sport & Health Sciences, Faculty of Health & Wellbeing, Brook Building, University of Central Lancashire, Preston, Lancashire, PR1 2HE, United Kingdom. Electronic address: kbeaver@uclan.ac.uk.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Martin-Hirsch', 'Affiliation': 'Department of Obstetrics & Gynaecology, Lancashire Teaching Hospitals NHS Foundation Trust, Royal Preston Hospital, Sharoe Green Lane, Fulwood, Preston, Lancashire, PR2 9HT, United Kingdom. Electronic address: martin.hirsch@mac.com.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Williamson', 'Affiliation': 'School of Sport & Health Sciences, Faculty of Health & Wellbeing, Brook Building, University of Central Lancashire, Preston, Lancashire, PR1 2HE, United Kingdom. Electronic address: swilliamson2@uclan.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kyrgiou', 'Affiliation': ""Department of Surgery and Cancer, Institute of Reproductive and Development Biology, Faculty of Medicine, Imperial College London, W12 0NN, United Kingdom; Queen Charlotte's and Chelsea-Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, W12 0HS, United Kingdom. Electronic address: m.kyrgiou@imperial.ac.uk.""}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101704']
569,31879033,"The SYDNEY Device Study: A Multicenter, Randomized, Open-label Usability Study of a 2-mL Alirocumab Autoinjector Device.","PURPOSE


The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab has produced significant reductions in LDL-C at a dose of 300 mg q4w administered as 2 separate 150-mg injections via a 1-mL autoinjector (AI). A recently developed 2-mL device (SYDNEY) permits the administration of a single 300mg dose of alirocumab.
METHODS


We assessed the usability and product technical complaints (PTCs) reported by patients using the 2-mL SYDNEY device in unsupervised settings, adverse events, and effects on LDL-C, in a multicenter, randomized, open-label, 16-week study conducted in the United States. For their first dose, 69 patients with hypercholesterolemia despite receiving statin with or without other lipid-lowering therapy randomly received supervised, self-administered alirocumab 300 mg via 1 × 300 mg injection with the SYDNEY device (n = 35) or 2 × 150-mg injections with the currently approved AI (n = 34). All continuing patients subsequently received unsupervised, self-administered alirocumab 300 mg q4w using the SYDNEY device at weeks 4, 8, and 12. The primary end point was the proportion of SYDNEY device-associated PTCs related to the use of the unsupervised injections.
FINDINGS


Baseline characteristics between the study arms varied only in a higher percentage of males being randomized to the study arm using the SYDNEY device (74.3%) compared with the AI arm (44.1%). A single PTC was reported during the unsupervised injections (0.5%; 1 of 196 injections; 95% CI, 0.0%-3.2%). This event was classified as patient related as opposed to device related. No PTCs occurred during supervised injections. Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively. LDL-C reductions persisted for 16 weeks. The most common adverse event was upper respiratory tract infection (3 with SYDNEY and 0 with the AI during weeks 0-4).
IMPLICATIONS


The SYDNEY device allowed for a single 2-mL injection of alirocumab 300 mg, providing substantial LDL-C reductions with no new product technical issues or no new safety concerns compared with the currently marketed 1-mL AI device. In conclusion, the 2-mL SYDNEY device provides patients with the possibility of injecting the 300-mg alirocumab dose as a single injection. ClinicalTrials.gov identifier: NCT03415178.",2020,"Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively.",['69 patients with hypercholesterolemia despite receiving statin with or without other lipid-lowering therapy randomly received'],"['300\xa0mg via 1\xa0×', 'supervised, self-administered alirocumab', 'alirocumab', 'XX:XXX-XXX', '2-mL Alirocumab Autoinjector Device']","['usability and product technical complaints (PTCs', 'LDL-C reductions', 'Mean LDL-C reductions', 'mean LDL-C reductions', 'proportion of SYDNEY device-associated PTCs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",69.0,0.138074,"Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively.","[{'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA, United States. Electronic address: juan.frias@nritrials.com.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Koren', 'Affiliation': 'Jacksonville Center For Clinical Research, Jacksonville, FL, United States.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Loizeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Merino-Trigo', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States.'}, {'ForeName': 'Mary Alice', 'Initials': 'MA', 'LastName': 'Raudenbush', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States.'}, {'ForeName': 'Isabela', 'Initials': 'I', 'LastName': 'Batsu', 'Affiliation': 'Sanofi, Bridgewater, NJ, United States.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.008']
570,31764194,The role of computer-based clinical decision support systems to deliver protective mechanical ventilation.,"PURPOSE OF REVIEW


Mechanical ventilation of adults and children with acute respiratory failure necessitates balancing lung and diaphragm protective ventilation. Computerized decision support (CDS) offers advantages in circumstances where complex decisions need to be made to weigh potentially competing risks, depending on the physiologic state of the patient.
RECENT FINDINGS


Significant variability in how ventilator protocols are applied still exists and clinical data show that there continues to be wide variability in ventilator management. We have developed a CDS, which we are currently testing in a Phase II randomized controlled trial. The CDS is called Real-time Effort Driven ventilator management (REDvent). We will describe the rationale and methods for development of CDS for lung and diaphragm protective ventilation, using the REDvent CDS as an exemplar.
SUMMARY


Goals for achieving compliance and physiologic objectives can be met when CDS instructions are simple and explicit, provide the clinician with the underlying rule set, permit acceptable reasons for declining and allow for iterative adjustments.",2020,"Computerized decision support (CDS) offers advantages in circumstances where complex decisions need to be made to weigh potentially competing risks, depending on the physiologic state of the patient.
",['adults and children with acute respiratory failure necessitates balancing lung and diaphragm protective ventilation'],['Computerized decision support (CDS'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.0361634,"Computerized decision support (CDS) offers advantages in circumstances where complex decisions need to be made to weigh potentially competing risks, depending on the physiologic state of the patient.
","[{'ForeName': 'Robinder G', 'Initials': 'RG', 'LastName': 'Khemani', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Hotz', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Sward', 'Affiliation': 'College of Nursing and Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Christopher J L', 'Initials': 'CJL', 'LastName': 'Newth', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California.""}]",Current opinion in critical care,['10.1097/MCC.0000000000000688']
571,31839279,"Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial.","BACKGROUND


Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups.
METHODS


We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921.
FINDINGS


Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95% BCrI 1·00-5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group.
INTERPRETATION


Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner.
FUNDING


European Commission's Seventh Framework Programme.",2020,"Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72.","['patients with influenza-like illness', '36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model', '3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93', 'Between Jan 15, 2016, and April 12, 2018', 'patients aged 1 year and older presenting with influenza-like illness in primary care', 'Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner', 'primary care', '3059 participants had PCR-confirmed influenza infection', 'Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone']","['oseltamivir', 'Oseltamivir plus usual care versus usual care']","['burden of vomiting or nausea', 'Time to recovery', 'time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",3059.0,0.251885,"Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72.","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Department of Primary Care Health Services, University of Oxford, Oxford, UK. Electronic address: christopher.butler@phc.ox.ac.uk.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Department of Primary Care Health Services, University of Oxford, Oxford, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants, Austin, Texas; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Holmes', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Centre for General Practice, Department of Primary and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Department of Primary Care Health Services, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, CA, USA; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Berry Consultants, Austin, TX, USA.'}, {'ForeName': 'Maciek', 'Initials': 'M', 'LastName': 'Godycki-Cwirko', 'Affiliation': 'Centre for Family and Community Medicine, Faculty of Health Sciences, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Chlabicz', 'Affiliation': 'Department of Family Medicine, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Lionis', 'Affiliation': 'Clinic of Social and Family Medicine, Faculty of Medicine, University of Crete, Crete, Greece.'}, {'ForeName': 'Bohumil', 'Initials': 'B', 'LastName': 'Seifert', 'Affiliation': 'Department of General Practice, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Pär-Daniel', 'Initials': 'PD', 'LastName': 'Sundvall', 'Affiliation': 'Research and Development Primary Health Care-Region Västra Götaland, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Colliers', 'Affiliation': 'Centre for General Practice, Department of Primary and Interdisciplinary Care, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Aabenhus', 'Affiliation': 'Section and Research Unit of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'Section and Research Unit of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Jonassen Harbin', 'Affiliation': 'Antibiotic Center for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindbæk', 'Affiliation': 'Antibiotic Center for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Glinz', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Bernadett', 'Initials': 'B', 'LastName': 'Kovács', 'Affiliation': 'Drug Research Centre, Balatonfüred, Hungary.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Radzeviciene Jurgute', 'Affiliation': 'JSC Mano seimos gydytojas (My family doctor), Klaipeda, Lithuania.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Touboul Lundgren', 'Affiliation': ""Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Murphy', 'Affiliation': 'Health Research Board Primary Care Clinical Trial Network Ireland, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'De Sutter', 'Affiliation': 'Center for Family Medicine UGent, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Openshaw', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Menno D', 'Initials': 'MD', 'LastName': 'de Jong', 'Affiliation': 'Department of Medical Microbiology, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': 'ConfluenceStat, Orlando, FL, USA; College of Medicine, University of Central Florida, Orlando, FL, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Matheeussen', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Ieven', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)32982-4']
572,31860096,The Acute Kidney Outreach to Prevent Deterioration and Death trial: a large pilot study for a cluster-randomized trial.,"BACKGROUND AND OBJECTIVES


The Acute Kidney Outreach to Reduce Deterioration and Death trial was a large pilot study for a cluster-randomized trial of acute kidney injury (AKI) outreach.
METHODS


An observational control (before) phase was conducted in two teaching hospitals (9 miles apart) and their respective catchment areas. In the intervention (after) phase, a working-hours AKI outreach service operated for the intervention hospital/area for 20 weeks, with the other site acting as a control. All AKI alerts in both hospital and community patients were screened for inclusion. Major exclusion criteria were patients who were at the end of life, unlikely to benefit from outreach, lacking mental capacity or already referred to the renal team. The intervention arm included a model of escalation of renal care to AKI patients, depending on AKI stage. The 30-day primary outcome was a combination of death, or deterioration, as shown by any need for dialysis or progression in AKI stage. A total of 1762 adult patients were recruited; 744 at the intervention site during the after phase.
RESULTS


A median of 3.0 non-medication recommendations and 0.5 medication-related recommendations per patient were made by the outreach team a median of 15.7 h after the AKI alert. Relatively low rates of the primary outcomes of death within 30 days (11-15%) or requirement for dialysis (0.4-3.7%) were seen across all four groups. In an exploratory analysis, at the intervention hospital during the after phase, there was an odds ratio for the combined primary outcome of 0.73 (95% confidence interval 0.42-1.26; P = 0.26).
CONCLUSIONS


An AKI outreach service can provide standardized specialist care to those with AKI across a healthcare economy. Trials assessing AKI outreach may benefit from focusing on those patients with 'mid-range' prognosis, where nephrological intervention could have the most impact.",2019,An observational control (before) phase was conducted in two teaching hospitals (9 miles apart) and their respective catchment areas.,"['Major exclusion criteria were patients who were at the end of life, unlikely to benefit from outreach, lacking mental capacity or already referred to the renal team', '1762 adult patients were recruited; 744 at the intervention site during the after phase', 'two teaching hospitals (9\u2009miles apart) and their respective catchment areas']",[],"['requirement for dialysis', 'death', 'combination of death, or deterioration, as shown by any need for dialysis or progression in AKI stage']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0007403', 'cui_str': 'Health Service Area'}]",[],"[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",1762.0,0.310789,An observational control (before) phase was conducted in two teaching hospitals (9 miles apart) and their respective catchment areas.,"[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Thomas', 'Affiliation': 'Department of Renal Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital, Birmingham, UK.'}, {'ForeName': 'Tarek S', 'Initials': 'TS', 'LastName': 'Abdelaziz', 'Affiliation': 'Department of Internal Medicine, Nephrology Unit, School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Alice J', 'Initials': 'AJ', 'LastName': 'Sitch', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Baharani', 'Affiliation': 'Department of Renal Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital, Birmingham, UK.'}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Temple', 'Affiliation': 'Department of Renal Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital, Birmingham, UK.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz246']
573,28347919,Autophagy-related polymorphisms predict hypertension in patients with metastatic colorectal cancer treated with FOLFIRI and bevacizumab: Results from TRIBE and FIRE-3 trials.,"PURPOSE


The most frequent bevacizumab-related side-effects are hypertension, proteinuria, bleeding and thromboembolism. To date, there is no biomarker that predicts anti-VEGF-associated toxicity. As autophagy inhibits angiogenesis, we hypothesised that single-nucleotide polymorphisms (SNPs) within autophagy-related genes may predict bevacizumab-mediated toxicity in patients with metastatic colorectal cancer (mCRC).
PATIENTS AND METHODS


Patients with mCRC treated with first-line FOLFIRI and bevacizumab in two phase III randomised trials, namely the TRIBE trial (n = 219, discovery cohort) and the FIRE-3 trial (n = 234, validation cohort) were included in this study. Patients receiving treatment with FOLFIRI and cetuximab (FIRE-3, n = 204) served as a negative control. 12 SNPs in eight autophagy-related genes (ATG3/5/8/13, beclin 1, FIP200, unc-51-like kinase 1, UVRAG) were analysed by PCR-based direct sequencing.
RESULTS


The FIP200 rs1129660 variant showed significant associations with hypertension in the TRIBE cohort. Patients harbouring any G allele of the FIP200 rs1129660 SNP showed a significantly lower rate of grade 2-3 hypertension compared with the A/A genotype (3% versus 15%, odds ratio [OR] 0.17; 95% confidence interval [CI], 0.02-0.73; P = 0.009). Similarly, G allele carriers of the FIP200 rs1129660 SNP were less likely to develop grade 2-3 hypertension than patients with an A/A genotype in the FIRE-3 validation cohort (9% versus 20%, OR 0.43; 95% CI, 0.14-1.11; P = 0.077), whereas this association could not be observed in the control cohort (12% versus 9%, OR 1.40; 95% CI, 0.45-4.04; P = 0.60).
CONCLUSION


This is the first report demonstrating that polymorphisms in the autophagy-related FIP200 gene may predict hypertension in patients with mCRC treated with FOLFIRI and bevacizumab.",2017,"Patients harbouring any G allele of the FIP200 rs1129660 SNP showed a significantly lower rate of grade 2-3 hypertension compared with the A/A genotype (3% versus 15%, odds ratio [OR] 0.17; 95% confidence interval [CI], 0.02-0.73; P = 0.009).","['patients with metastatic colorectal cancer (mCRC', 'patients with metastatic colorectal cancer treated with', 'Patients with mCRC treated with first-line FOLFIRI and bevacizumab in two phase III randomised trials, namely the TRIBE trial (n\xa0=\xa0219, discovery cohort) and the FIRE-3 trial (n\xa0=\xa0234, validation cohort', 'patients with mCRC treated with']","['FOLFIRI and bevacizumab', 'FOLFIRI and cetuximab (FIRE-3, n\xa0']",['rate of grade 2-3 hypertension'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.0991665,"Patients harbouring any G allele of the FIP200 rs1129660 SNP showed a significantly lower rate of grade 2-3 hypertension compared with the A/A genotype (3% versus 15%, odds ratio [OR] 0.17; 95% confidence interval [CI], 0.02-0.73; P = 0.009).","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Berger', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Hanna', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sunakawa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Via Gattamelata 64, 35128 Padova, Italy.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsusaka', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Dongyun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Groshen', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Mitsukuni', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Via Gattamelata 64, 35128 Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Via Roma 67, 56126 Pisa, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Via Roma 67, 56126 Pisa, Italy.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Marchioninistrasse 15, 81377 Munich, Germany.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Via Gattamelata 64, 35128 Padova, Italy.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Marchioninistrasse 15, 81377 Munich, Germany.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA; Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA. Electronic address: lenz@med.usc.edu.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2017.02.020']
574,31810418,Immunogenicity and safety of a multi-dose quadrivalent inactivated influenza vaccine in individuals aged 6 months to 17 years: a randomized phase III trial.,"Annual vaccination is the most effective way to prevent seasonal influenza. Influenza vaccines in multi-dose vial (MDV) formats can facilitate timely vaccination of large populations by reducing per-dose costs and cold storage requirements compared to single-dose pre-filled syringe (PFS) formats. MDV vaccines require thiomersal or another preservative to prevent microbial contamination. We conducted a randomized, open-label trial in 302 healthy subjects aged 6 months to 17 years to evaluate the immunogenicity and safety of a quadrivalent influenza vaccine (QIV) in a thiomersal-containing MDV format compared to the licensed thiomersal-free PFS format. Subjects were randomly assigned in a 1:1 ratio to receive the MDV (n = 153) or PFS (n = 149) format. Post-vaccination hemagglutination inhibition titers for all four vaccine strains were ≥4.9-fold higher than baseline titers with no difference in magnitude between the MDV and PFS groups. Seroconversion rates per strain were also comparable between the two groups. There were no differences in reactogenicity or safety between the two vaccine formats. These results showed that the MDV format of QIV was as safe and immunogenic as the PFS format in infants, children, and adolescents. These findings support the use of MDV QIV as a resource-saving alternative for seasonal influenza vaccination.",2020,Post-vaccination hemagglutination inhibition titers for all four vaccine strains were ≥4.9-fold higher than baseline titers with no difference in magnitude between the MDV and PFS groups.,"['302 healthy subjects aged 6\xa0months to 17\xa0years', 'individuals aged 6 months to 17 years']","['Influenza vaccines', 'multi-dose quadrivalent inactivated influenza vaccine', 'PFS', 'MDV', 'quadrivalent influenza vaccine (QIV) in a thiomersal-containing MDV format compared to the licensed thiomersal-free PFS format']","['Seroconversion rates per strain', 'reactogenicity or safety', 'immunogenicity and safety', 'Post-vaccination hemagglutination inhibition titers', 'Immunogenicity and safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0039867', 'cui_str': 'thiomersal'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",302.0,0.052979,Post-vaccination hemagglutination inhibition titers for all four vaccine strains were ≥4.9-fold higher than baseline titers with no difference in magnitude between the MDV and PFS groups.,"[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Ojeda', 'Affiliation': 'Global Clinical Science, Sanofi Pasteur , Mexico City, Mexico.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Arredondo', 'Affiliation': 'Instituto Nacional de Pediatría, Unidad de Investigación Clínica , Mexico City, Mexico.'}, {'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Salcedo', 'Affiliation': 'Hospital General de Ecatepec ""Las Américas"", Fraccionamiento las Américas , Ecatepec de Morelos, Mexico.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Paredes-Paredes', 'Affiliation': 'JM Research Clinical Research Center , Cuernavaca, Mexico.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dupuy', 'Affiliation': ""Global Biostatistical Sciences, Sanofi Pasteur , Marcy l'Étoile, France.""}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Petit', 'Affiliation': ""Global Clinical Immunology, Sanofi Pasteur , Marcy l'Étoile, France.""}, {'ForeName': 'Anne Laure', 'Initials': 'AL', 'LastName': 'Chabanon', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Campus Sanofi Lyon , Lyon, France.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Mexico City, Mexico.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Bruijn', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur , Marcy l'Étoile, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pepin', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur , Marcy l'Étoile, France.""}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1697595']
575,31870415,"Design and rationale for a pragmatic cluster randomized trial of the Cardiovascular Health Awareness Program (CHAP) for social housing residents in Ontario and Quebec, Canada.","BACKGROUND


The Cardiovascular Health Awareness Program (CHAP) uses volunteers to provide cardiovascular disease (CVD) and diabetes screening in a community setting, referrals to primary care providers, and locally available programs targeting lifestyle modification. CHAP has been adapted to target older adults residing in social housing, a vulnerable segment of the population. Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes. The study objective is to evaluate whether there is a reduction in unplanned CVD-related Emergency Department (ED) visits and hospital admissions among residents of social seniors' housing buildings receiving the CHAP program for 1 year compared to residents in matched buildings not receiving the program.
METHODS/DESIGN


This is a pragmatic, cluster randomized controlled trial in community-based social (subsidized) housing buildings in Ontario and Quebec. All residents of 14 matched pairs (intervention/control) of apartment buildings will be included. Buildings with 50-200 apartment units with the majority of residents aged 55+ and a unique postal code are included. All individuals residing within the buildings at the start of the intervention period are included (intention to treat, open cohort). The intervention instrument consists of CHAP screens for high blood pressure using automated blood pressure monitors and for diabetes using the Canadian Diabetes Risk (CANRISK) assessment tool. Monthly drop-in sessions for screening/monitoring are held within a common area of the building. Group health education sessions are also held monthly. Reports are sent to family doctors, and attendees are encouraged to visit their family doctor. The primary outcome measure is monthly CVD-related ED visits and hospitalizations over a 1-year period post randomization. Secondary outcomes are all ED visits, hospitalizations, quality of life, cost-effectiveness, and participant experience.
DISCUSSION


It is anticipated that CVD-related ED visits and hospitalizations will decrease in the intervention buildings. Using the volunteer-led CHAP program, there is significant opportunity to improve the health of older adults in social housing.
TRIAL REGISTRATION


ClinicalTrials.gov,NCT03549845. Registered on 15 May 2018. Updated on 21 May 2019.",2019,"Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes.","['Buildings with 50-200 apartment units with the majority of residents aged 55+ and a unique postal code are included', 'All residents of 14 matched pairs (intervention/control) of apartment buildings will be included', 'community-based social (subsidized) housing buildings in Ontario and Quebec', 'All individuals residing within the buildings at the start of the intervention period are included (intention to treat, open cohort', 'social housing residents in Ontario and Quebec, Canada', 'Older adults living in social housing report poorer health status', ""unplanned CVD-related Emergency Department (ED) visits and hospital admissions among residents of social seniors' housing buildings receiving the CHAP program for 1 year compared to residents in matched buildings not receiving the program""]","['Cardiovascular Health Awareness Program (CHAP', 'CHAP screens', 'CHAP']","['all ED visits, hospitalizations, quality of life, cost-effectiveness, and participant experience', 'monthly CVD-related ED visits and hospitalizations over a 1-year period post randomization']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0457933', 'cui_str': 'Residential flat'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557593', 'cui_str': 'Apartment building'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0588432', 'cui_str': 'Housing report (record artifact)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0047101', 'cui_str': '3-(3-cholamidopropyl)dimethylammoniumpropane sulfonate'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0047101', 'cui_str': '3-(3-cholamidopropyl)dimethylammoniumpropane sulfonate'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.0447912,"Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes.","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': 'Department of Family Medicine, McMaster University, 100 Main Street West, DBHSC, 5th Floor, Hamilton, ON, L8P 1H6, Canada. gina.agarwal@gmail.com.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Girard', 'Affiliation': ""Centre hospitalier de l'Université de Montréal (CHUM), Montréal, Canada.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Angeles', 'Affiliation': 'Department of Family Medicine, McMaster University, 100 Main Street West, DBHSC, 5th Floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pirrie', 'Affiliation': 'Department of Family Medicine, McMaster University, 100 Main Street West, DBHSC, 5th Floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Marie-Thérèse', 'Initials': 'MT', 'LastName': 'Lussier', 'Affiliation': 'Department of Family and Emergency Medicine, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Marzanek', 'Affiliation': 'Department of Family Medicine, McMaster University, 100 Main Street West, DBHSC, 5th Floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Department of Family Medicine, McMaster University, 100 Main Street West, DBHSC, 5th Floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Paterson', 'Affiliation': 'Department of Family Medicine, McMaster University, 100 Main Street West, DBHSC, 5th Floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Kaczorowski', 'Affiliation': ""Centre hospitalier de l'Université de Montréal (CHUM), Montréal, Canada.""}]",Trials,['10.1186/s13063-019-3806-5']
576,31870424,Evaluation of the efficacy of simplified nutritional instructions from physicians on dietary salt restriction for patients with type 2 diabetes mellitus consuming excessive salt: protocol for a randomized controlled trial.,"BACKGROUND


Hypertension is present in more than 50% of patients with type 2 diabetes mellitus. Dietary salt restriction is recommended for the management of high blood pressure. Instructions on dietary salt restriction, provided by a dietitian, have been shown to help patients reduce their salt intake. However, appointments for the dietitians in hospitals are often already fully booked, making it difficult for patients to receive instructions on the same day as the outpatient clinic visit.
AIM


The aim of this trial is to test a new intervention to assess whether guidance on dietary salt restriction provided by physicians during outpatient visits is effective in reducing salt intake in patients with type 2 diabetes mellitus who have an excessive salt intake.
METHODS


In this unblinded randomized controlled trial (RCT), a total of 200 patients, male or female, aged between 20 and 90 years, who have type 2 diabetes mellitus and consume excessive salt will be randomly assigned to two groups: an intervention group and a control group. In addition to being given routine treatment, participants in the intervention group will be given individual guidance on restricting their dietary salt intake by a physician upon enrollment. The control group will only be given routine treatment. Participants will be followed up for 24 weeks. The primary outcome will be dietary salt intake, which will be assessed at baseline and at 8, 16, and 24 weeks. The secondary outcomes, including body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level, will be assessed at baseline and at 8, 16, and 24 weeks.
DISCUSSION


The results of this RCT have the potential to provide a simple and novel clinical approach to reduce salt intake among patients with type 2 diabetes, making regular visits to their physician, in outpatient facilities. This protocol will contribute to the literature because it describes a practical intervention that has not been tested previously, and it may serve as guidance to other researchers interested in testing similar interventions.
TRIAL REGISTRATION


University Hospital Medical Information Network (UMIN), UMIN000028809. Registered retrospectively on 24 August 2017. http://www.umin.ac.jp.",2019,"The secondary outcomes, including body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level, will be assessed at baseline and at 8, 16, and 24 weeks.
","['patients with type 2 diabetes mellitus who have an excessive salt intake', 'patients with type 2 diabetes', 'patients with type 2 diabetes mellitus', '200 patients, male or female, aged between 20\u2009and 90\u2009years, who have type 2 diabetes mellitus and consume excessive salt', 'patients with type 2 diabetes mellitus consuming excessive salt']","['simplified nutritional instructions', 'Dietary salt restriction']","['dietary salt intake', 'body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0425431', 'cui_str': 'Dietary salt intake (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",200.0,0.113015,"The secondary outcomes, including body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level, will be assessed at baseline and at 8, 16, and 24 weeks.
","[{'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Ushigome', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan. emis@koto.kpu-m.ac.jp.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Oyabu', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyoto First Red Cross Hospital, 749 Honmachi 15-chome, Higashiyama-ku, Kyoto, 605-0981, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Nobuko', 'Initials': 'N', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Kitae', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Iwai', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Ushigome', 'Affiliation': 'Department of Organ Transplantation and General Surgery, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Yokota', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, Hokkaido University, Kita 8, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0808, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}]",Trials,['10.1186/s13063-019-3864-8']
577,31870427,Non-placement versus placement of a drainage tube around the cervical anastomosis in McKeown esophagectomy: study protocol for a randomized controlled trial.,"BACKGROUND


Esophagectomy with extended lymphadenectomy remains the mainstay of treatment for localized esophageal cancer. Currently, transthoracic and abdominal esophagectomy with cervical anastomosis (McKeown esophagectomy) is a frequently used technique in Japan. However, cervical anastomosis is still an invasive procedure with a high incidence of anastomotic leakage. The use of a drainage tube to treat anastomotic leakage is effective, but the routine placement of a closed suction drain around the anastomosis at the end of the operation remains controversial. The objective of this study is to evaluate the postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and analgesic use with nonplacement of a cervical drainage tube as an alternative to placement of a cervical drainage tube.
METHODS


This is an investigator-initiated, investigator-driven, open-label, randomized controlled parallel-group, noninferiority trial. All adult patients (aged ≥20 and ≤85 years) with histologically proven, surgically resectable (cT1-3 N0-3 M0) squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid squamous cell carcinoma of the intrathoracic esophagus, and European Clinical Oncology Group performance status 0, 1, or 2 are assessed for eligibility. Patients (n = 110) with resectable esophageal cancer who provide informed consent in the outpatient clinic are randomized to either nonplacement of a cervical drainage tube (n = 55) or placement of a cervical drainage tube (n = 55). The primary outcome is the percentage of Clavien-Dindo grade 2 or higher anastomotic leakage.
DISCUSSION


This is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage. If our hypothesis is correct, nonplacement of a cervical drainage tube will be recommended because it is associated with a similar anastomotic leakage rate but less pain than placement of a cervical drainage tube.
TRIAL REGISTRATION


UMIN-CTR, 000031244. Registered on 1 May 2018.",2019,This is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage.,"['Patients (n\u2009', 'All adult patients (aged\u2009≥20 and\u2009≤85\u2009years) with histologically proven, surgically resectable (cT1-3\u2009N0-3 M0) squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid squamous cell carcinoma of the intrathoracic esophagus, and European Clinical Oncology Group performance status 0, 1, or 2 are assessed for eligibility', 'localized esophageal cancer', '110) with resectable esophageal cancer who provide informed consent in the outpatient clinic']","['nonplacement of a cervical drainage tube (n\u2009=\u200955) or placement of a cervical drainage tube', 'Esophagectomy with extended lymphadenectomy', 'placement versus placement of a drainage tube around the cervical anastomosis in McKeown esophagectomy', 'nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy', 'transthoracic and abdominal esophagectomy with cervical anastomosis (McKeown esophagectomy']","['postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and analgesic use', 'percentage of Clavien-Dindo grade 2 or higher anastomotic leakage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous cell carcinoma'}, {'cui': 'C1266005', 'cui_str': 'Basaloid squamous cell carcinoma'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1274034', 'cui_str': 'Clinical Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0472888', 'cui_str': 'McKeown esophagectomy (procedure)'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.180705,This is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage.,"[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Oshikiri', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan. oshikiri@med.kobe-u.ac.jp.'}, {'ForeName': 'Gosuke', 'Initials': 'G', 'LastName': 'Takiguchi', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Miura', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kanaji', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Division of Minimally Invasive Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Social Community Medicine and Health Science, Division of Community Medicine and Medical Network, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kakeji', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.'}]",Trials,['10.1186/s13063-019-3750-4']
578,31899253,Keys to healthy family child care homes: Results from a cluster randomized trial.,"Early care and education settings, such as family child care homes (FCCHs), are important venues for children's health promotion. Keys to Healthy Family Child Care Homes evaluated a FCCH-based intervention's impact on children's diet and physical activity. This study enrolled 496 children aged 1.5-4 years and 166 FCCH providers into a cluster-randomized control trial (intervention = 242 children/83 FCCHs, control = 254 children/83 FCCHs) conducted during 2013-2016. The 9-month intervention addressed provider health, health of the FCCH environment, and business practices, and was delivered through three workshops, three home visits, and nine phone calls. The attention control arm received a business-focused intervention. Primary outcomes were children's diet quality (2 days of observed intakes summarized into Healthy Eating Index scores) and moderate to vigorous physical activity (3 days of accelerometry) at the FCCH. Secondary outcomes were child body mass index (BMI), FCCH provider health behaviors, and FCCH nutrition and physical activity environments and business practices. Repeated measures analysis, using an intent-to-treat approach, accounting for clustering of children within FCCHs and adjusting for child age, sex, and BMI, was used to evaluate change (completed in 2018). Compared to controls, intervention children significantly improved their diet quality (5.39, p = .0002, CI = 2.53, 8.26) but not MVPA (0.31, p = .195, CI = -0.16, 0.79). Intervention FCCH providers significantly improved their diet quality and several components of their FCCH environment (i.e., time provided for physical activity, use of supportive physical activity practices, and engagement in nutrition and physical activity education/professional development). FCCHs are malleable settings for health promotion, especially diet quality. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.govNCT01814215.",2020,"Compared to controls, intervention children significantly improved their diet quality (5.39, p = .0002, CI = 2.53, 8.26) but not MVPA (0.31, p = .195, CI = -0.16, 0.79).","['healthy family child care homes', '496 children aged 1.5-4\u202fyears and 166 FCCH providers into a cluster-randomized control trial (intervention\u202f=\u202f242 children/83 FCCHs, control\u202f=\u202f254 children/83 FCCHs) conducted during 2013-2016', 'Healthy Family Child Care Homes']",['business-focused intervention'],"['diet quality', ""children's diet quality (2\u202fdays of observed intakes summarized into Healthy Eating Index scores) and moderate to vigorous physical activity"", 'child body mass index (BMI), FCCH provider health behaviors, and FCCH nutrition and physical activity environments and business practices']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018687'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0085936', 'cui_str': 'Business'}]",496.0,0.0422437,"Compared to controls, intervention children significantly improved their diet quality (5.39, p = .0002, CI = 2.53, 8.26) but not MVPA (0.31, p = .195, CI = -0.16, 0.79).","[{'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, CB # 7461, Chapel Hill, NC 27599-7461, USA; Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC 27599-7426, USA. Electronic address: dsward@email.unc.edu.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC 27599-7426, USA.'}, {'ForeName': 'Regan V', 'Initials': 'RV', 'LastName': 'Burney', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC 27599-7426, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, CB # 7461, Chapel Hill, NC 27599-7461, USA; Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, 1700 Martin L. King Jr. Blvd., CB 7426, Chapel Hill, NC 27599-7426, USA.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Benjamin-Neelon', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, 41 Lower College Road, Kingston, RI 02881, USA.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Østbye', 'Affiliation': 'Duke University Department of Family Medicine and Community Health, Duke University Medical Center, W Main St 2200, Suite 622, Durham, NC 27710, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2019.105974']
579,31486620,Sensory assessment and block duration of transmuscular quadratus lumborum block at L2 versus L4 in volunteers: a randomized controlled trial.,"BACKGROUND


The efficacy of an ultrasound guided transmuscular quadratus lumborum block (QLB) for perioperative analgesia of the upper and lower abdomen remain debatable. The purpose of this study was to compare the cutaneous sensory blocked area (CSBA) between QLB blocks performed at the L2 vs. L4 levels.
METHODS


Twenty-two healthy volunteers were randomized 1:1 to receive an ultrasound guided right transmuscular QLB at the L2 level (group QL2) or L4 level (group QL4). A cold stimulus was applied for testing of the CSBA at 30 minutes after the blockade was performed. The CSBA was mapped and then calculated. Three hours after the QLB, a cold stimulus was applied once every hour until sensation returned normal and the effective block duration for each volunteer was determined and recorded.
RESULTS


The maximum cephalad dermatome level reached was T7 in group QL2 vs. T11 in group QL4, respectively. Caudally, both groups reached the L2 dermatome level. The QL2 block primarily affected dermatomes T9 to L1, while the QL4 block affected T11 to L1. The total CSBA was larger in QL2 group than that in QL4 group (748 [171] cm2 vs. 501 [186] cm2, P=0.004). The effective duration of the QLB was significantly longer in group QL2 than in group QL4 (18.5 [2.0]h vs. 14.1 [4.7]h, P=0.012). The number of affected dermatomes assessed by cold test was significantly larger for the volunteers in groups QL2 (4.6 [0.81] vs. 2.1 [0.30], P<0.001).
CONCLUSIONS


Ultrasound guided transmuscular QLB injection of 0.375% 20 mL ropivacaine at the L2 level produced a widespread cutaneous sensory blockade and a prolonged sensory block to cold sensation compared with the L4 level.",2019,"The maximum cephalad dermatome level reached was T7 in group QL2 vs. T11 in group QL4, respectively.","['Twenty-two healthy volunteers', 'volunteers']","['ultrasound guided transmuscular quadratus lumborum block (QLB', 'ultrasound guided right transmuscular QLB at the L2 level (group QL2) or L4 level (group QL4', 'transmuscular quadratus lumborum block at L2 versus L4', 'ropivacaine']","['total CSBA', 'effective duration of the QLB', 'L2 dermatome level', 'number of affected dermatomes assessed by cold test', 'cutaneous sensory blocked area (CSBA', 'maximum cephalad dermatome level']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0392338', 'cui_str': 'Dermatome (body structure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}]",22.0,0.0411919,"The maximum cephalad dermatome level reached was T7 in group QL2 vs. T11 in group QL4, respectively.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jingxiong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Sainan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, the Affiliated Yueqing Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, Ohio State University Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Papadimos', 'Affiliation': 'Department of Anesthesiology, Ohio State University Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Xuzhong', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China - chhfei@126.com.'}]",Minerva anestesiologica,['10.23736/S0375-9393.19.13656-5']
580,31881993,An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial.,"BACKGROUND


Posttraumatic stress disorder (PTSD) rarely remits over time, and if left untreated, leads to significant distress, functional impairment, and increased health care costs. Fortunately, effective evidence-based treatments (EBTs) for PTSD, such as Prolonged Exposure (PE), exist. Despite their availability and efficacy, a significant number of individuals with PTSD do not initiate treatment when offered or dropout prematurely. One proposed theory suggests that the emotional-numbing symptoms of PTSD (e.g., blunted affect, apathy) can serve as a barrier to engaging in, and successfully completing, treatment; and the broad human-animal interaction (HAI) literature available suggests that HAI can potentially reduce emotional numbing related to PTSD. Accordingly, this manuscript describes an ongoing, federally funded, randomized controlled trial testing the efficacy of RESCUE, an HAI intervention, as a viable adjunctive treatment component for PE.
METHODS/DESIGN


The study will include 70 veterans with PTSD treated at a Southeastern Veterans Affairs Medical Center (VAMC). All participants in the trial receive up to 12 sessions of PE. Participants are randomly assigned 1:1 to (1) volunteer at a local animal shelter or (2) volunteer at a community agency of their choice as part of their in-vivo exposure exercises for PE. Outcomes will be examined via standard clinical interviews, self-report questionnaires, and thematic interviews.
DISCUSSION


It is hypothesized that participants in the HAI condition will report greater decreases in emotional-numbing symptoms and increased treatment compliance and completion rates relative to those in the community volunteer condition. If successful, RESCUE, could be easily incorporated into standard PE and broadly disseminated.
TRIAL REGISTRATION


ClinicalTrials.gov. ID: NCT03504722. Retrospectively registered on 2 May 2017.",2019,It is hypothesized that participants in the HAI condition will report greater decreases in emotional-numbing symptoms and increased treatment compliance and completion rates relative to those in the community volunteer condition.,"['veterans with PTSD', '70 veterans with PTSD treated at a Southeastern Veterans Affairs Medical Center (VAMC']","['local animal shelter or (2) volunteer at a community agency of their choice as part of their in-vivo exposure exercises for PE', 'HAI intervention', 'adjunctive human-animal interaction intervention', 'PE']",['emotional-numbing symptoms'],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",70.0,0.0691209,It is hypothesized that participants in the HAI condition will report greater decreases in emotional-numbing symptoms and increased treatment compliance and completion rates relative to those in the community volunteer condition.,"[{'ForeName': 'Anouk L', 'Initials': 'AL', 'LastName': 'Grubaugh', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 109 Bee Street, Charleston, SC, 29401, USA. grubaugh@musc.edu.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Myers', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 109 Bee Street, Charleston, SC, 29401, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Keller', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 109 Bee Street, Charleston, SC, 29401, USA.'}, {'ForeName': 'Bethany C', 'Initials': 'BC', 'LastName': 'Wangelin', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 109 Bee Street, Charleston, SC, 29401, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Lozano', 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 109 Bee Street, Charleston, SC, 29401, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Tuerk', 'Affiliation': 'Sheila C. Johnson Center for Clinical Services, Department of Human Services, Curry School of Education, University of Virginia, 417 Emmet Street South, 400270, Charlottesville, VA, 22904, USA.'}]",Trials,['10.1186/s13063-019-3877-3']
581,31882012,Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial.,"BACKGROUND


Head and neck cancer (HNC) patients are at high risk for developing lymphedema and fibrosis (LEF) following cancer treatment. Once HNC patients develop LEF, they need to conduct life-long self-care to slow LEF progression and reduce associated symptom burden and functional deficits. Data demonstrate that inadequate LEF self-care may be a potentially remediable issue. The objective of this study is to explore the feasibility and preliminary efficacy of an Information-Motivation-Behavioral (IMB) Skills model-driven self-care program (SCP) to improve LEF management and reduce LEF-related symptom burden and functional impairments.
METHODS/DESIGN


This is a three-arm, prospective, randomized controlled clinical trial to compare: Group 1 - Usual Care, Group 2 - Usual Care Plus LEF-SCP, and Group 3 - Usual Care Plus LEF-SCP Plus Follow-Up. Participants will be HNC survivors aged > 18 years of age, who meet predefined inclusion and exclusion criteria. A sample size of 75 participants is targeted. Interventions will be provided by trained staff. The study assessments for all groups will take place at five points: study entry then 3, 6, 9, and 12 months post enrollment. Outcome measures include: (1) feasibility (barriers to implementation, safety, and satisfaction) of the proposed intervention; (2) self-efficacy and adherence to self-care; and (3) preliminary efficacy (LEF progression, symptom burden, and functional status) of the proposed intervention.
DISCUSSION


This will be the first study to evaluate the feasibility of a LEF-SCP in the HNC population and its impact on self-efficacy and adherence. Furthermore, it will evaluate the potential benefit of routine follow-up on adherence and fidelity to the self-care protocol. We expect that the trial will provide evidence supporting the feasibility of a LEF self-care program. In addition, we anticipate that preliminary data will support improved outcomes including increased adherence and fidelity, and decreased LEF-associated symptoms.
TRIAL REGISTRATION


ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.",2019,"Skills model-driven self-care program (SCP) to improve LEF management and reduce LEF-related symptom burden and functional impairments.
","['Head and neck cancer (HNC) patients', 'head and neck cancer survivors with lymphedema and fibrosis', 'Participants will be HNC survivors aged >\u200918\u2009years of age, who meet predefined inclusion and exclusion criteria']","['Group 1 - Usual Care, Group 2 - Usual Care Plus LEF-SCP, and Group 3 - Usual Care Plus LEF-SCP Plus Follow-Up', 'Information-Motivation-Behavioral (IMB', 'LEF-SCP', 'Skills model-driven self-care program (SCP', 'Self-care']","['adherence and fidelity, and decreased LEF-associated symptoms', ' (1) feasibility (barriers to implementation, safety, and satisfaction) of the proposed intervention; (2) self-efficacy and adherence to self-care; and (3) preliminary efficacy (LEF progression, symptom burden, and functional status) of the proposed intervention']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom (finding)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",75.0,0.10297,"Skills model-driven self-care program (SCP) to improve LEF management and reduce LEF-related symptom burden and functional impairments.
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': 'School of Nursing, University of Pennsylvania, 418 Curie Boulevard, Philadelphia, PA, 19104-4217, USA. jiedeng@nursing.upenn.edu.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'School of Nursing, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Murphy', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt Medical Center, Nashville, TN, USA.'}]",Trials,['10.1186/s13063-019-3819-0']
582,31882015,Virtual reality as an adjunct to anesthesia in the operating room.,"BACKGROUND


Advancements in virtual reality (VR) technology have resulted in its expansion into health care. Preliminary studies have found VR to be effective as an adjunct to anesthesia to reduce pain and anxiety for patients during upper gastrointestinal endoscopies, dental procedures and joint arthroplasties. Current standard care practice for upper extremity surgery includes a combination of regional anesthesia and intraoperative propofol sedation. Commonly, patients receive deep propofol sedation during these cases, leading to potentially avoidable risks of over-sedation, hypotension, upper airway obstruction, and apnea. The objective of this study is to evaluate the effectiveness of VR technology to promote relaxation for patients undergoing upper extremity surgery, thereby reducing intraoperative anesthetic requirements and improving the perioperative patient experience.
METHODS


In this single-center, randomized controlled trial, 40 adult patients undergoing upper extremity orthopedic surgery will be randomly allocated to either intraoperative VR immersion or usual care. VR immersion is designed to provide patients with a relaxing virtual environment to alleviate intraoperative anxiety. All patients receive a peripheral nerve block prior to surgery. Patients in the intervention group will select videos or immersive environments which will be played in the VR headset during surgery. An anesthesia provider will perform their usual clinical responsibilities intraoperatively and can administer anesthetic medications if and when clinically necessary. Patients in the control arm will undergo perioperative anesthesia according to standard care practice. The primary outcome is the difference in intraoperative propofol dose between the groups. Secondary outcomes include postoperative analgesia requirements and pain scores, length of stay in the postanesthesia care unit, overall patient satisfaction and postoperative functional outcomes.
DISCUSSION


It is unknown whether the use of VR during upper extremity surgery can reduce intraoperative anesthetic requirements, reduce perioperative complications, or improve the postoperative patient experience. A positive result from this clinical trial would add to the growing body of evidence that demonstrates the effectiveness of VR as an adjunct to anesthesia in reducing intraoperative pain and anxiety for multiple types of procedure. This could lead to a change in practice, with the introduction of a nonpharmacologic intervention potentially reducing the burden of over-sedation while still providing a satisfactory perioperative experience.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03614325. Registered on 9 July 2018.",2019,"Preliminary studies have found VR to be effective as an adjunct to anesthesia to reduce pain and anxiety for patients during upper gastrointestinal endoscopies, dental procedures and joint arthroplasties.","['40 adult patients undergoing upper extremity orthopedic surgery', 'patients undergoing upper extremity surgery']","['regional anesthesia and intraoperative propofol sedation', 'intraoperative VR immersion or usual care', 'VR immersion', 'peripheral nerve block prior to surgery', 'deep propofol sedation', 'VR technology']","['avoidable risks of over-sedation, hypotension, upper airway obstruction, and apnea', 'intraoperative pain and anxiety', 'postoperative analgesia requirements and pain scores, length of stay in the postanesthesia care unit, overall patient satisfaction and postoperative functional outcomes', 'pain and anxiety', 'intraoperative propofol dose']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",40.0,0.0541676,"Preliminary studies have found VR to be effective as an adjunct to anesthesia to reduce pain and anxiety for patients during upper gastrointestinal endoscopies, dental procedures and joint arthroplasties.","[{'ForeName': 'Adeel', 'Initials': 'A', 'LastName': 'Faruki', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA. afaruki@bidmc.harvard.edu.'}, {'ForeName': 'Thy', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Proeschel', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Nadav', 'Initials': 'N', 'LastName': 'Levy', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ip', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Mueller', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Banner-Goodspeed', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Gara"", 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.'}]",Trials,['10.1186/s13063-019-3922-2']
583,31694861,Efficacy and Safety of the Glucagon Receptor Antagonist RVT-1502 in Type 2 Diabetes Uncontrolled on Metformin Monotherapy: A 12-Week Dose-Ranging Study.,"OBJECTIVE


Evaluate the safety and efficacy of RVT-1502, a novel oral glucagon receptor antagonist, in subjects with type 2 diabetes inadequately controlled on metformin.
RESEARCH DESIGN AND METHODS


In a phase 2, double-blind, randomized, placebo-controlled study, subjects with type 2 diabetes ( n  = 166) on a stable dose of metformin were randomized (1:1:1:1) to placebo or RVT-1502 5, 10, or 15 mg once daily for 12 weeks. The primary end point was change from baseline in HbA 1c  for each dose of RVT-1502 compared with placebo. Secondary end points included change from baseline in fasting plasma glucose (FPG) and safety assessments.
RESULTS


Over 12 weeks, RVT-1502 significantly reduced HbA 1c  relative to placebo by 0.74%, 0.76%, and 1.05% in the 5-, 10-, and 15-mg groups ( P  < 0.001), respectively, and FPG decreased by 2.1, 2.2, and 2.6 mmol/L ( P  < 0.001). The proportions of subjects achieving an HbA 1c  <7.0% were 19.5%, 39.5%, 39.5%, and 45.0% with placebo and RVT-1502 5, 10, and 15 mg ( P  ≤ 0.02 vs. placebo). The frequency of hypoglycemia was low, and no episodes were severe. Mild increases in mean aminotransferase levels remaining below the upper limit of normal were observed with RVT-1502 but were reversible and did not appear to be dose related, with no other liver parameter changes. Weight and lipid changes were similar between RVT-1502 and placebo. RVT-1502-associated mild increases in blood pressure were not dose related or consistent across time.
CONCLUSIONS


Glucagon receptor antagonism with RVT-1502 significantly lowers HbA 1c  and FPG, with a safety profile that supports further clinical development with longer-duration studies (NCT02851849).",2020,"RESULTS


Over 12 weeks, RVT-1502 significantly reduced HbA 1c  relative to placebo by 0.74%, 0.76%, and 1.05% in the 5-, 10-, and 15-mg groups ( P  < 0.001), respectively, and FPG decreased by 2.1, 2.2, and 2.6 mmol/L ( P  < 0.001).","['subjects with type 2 diabetes inadequately controlled on metformin', 'subjects with type 2 diabetes ( n  = 166) on a stable dose of']","['RVT-1502 and placebo', 'placebo or RVT-1502', 'metformin', 'RVT-1502', 'placebo', 'Glucagon Receptor Antagonist RVT-1502']","['Weight and lipid changes', 'blood pressure', 'FPG', 'fasting plasma glucose (FPG) and safety assessments', 'Efficacy and Safety', 'frequency of hypoglycemia', 'mean aminotransferase levels']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.206254,"RESULTS


Over 12 weeks, RVT-1502 significantly reduced HbA 1c  relative to placebo by 0.74%, 0.76%, and 1.05% in the 5-, 10-, and 15-mg groups ( P  < 0.001), respectively, and FPG decreased by 2.1, 2.2, and 2.6 mmol/L ( P  < 0.001).","[{'ForeName': 'Jeremy H', 'Initials': 'JH', 'LastName': 'Pettus', 'Affiliation': 'University of California San Diego, San Diego, CA jpettus@ucsd.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Alessio"", 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Vajda', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Pipkin', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Williamson', 'Affiliation': 'Medpace, Cincinnati, OH.'}, {'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Zangmeister', 'Affiliation': 'Medpace, Cincinnati, OH.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhi', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}, {'ForeName': 'Keith B', 'Initials': 'KB', 'LastName': 'Marschke', 'Affiliation': 'Ligand Pharmaceuticals Incorporated, San Diego, CA.'}]",Diabetes care,['10.2337/dc19-1328']
584,31870413,Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? Protocol for a feasibility study.,"BACKGROUND


Consultations in primary care for symptoms of urinary tract infections (UTIs) are common and patients are frequently treated with antibiotics. Given increasing antimicrobial resistance, there has been interest in non-antibiotic treatment options for common infections. One such option is the use of cranberry extract to treat symptoms attributable to UTIs.
METHODS


A target of 45 women consulting in primary care, with symptoms suggestive of an uncomplicated UTI for whom the practitioner would normally prescribe antibiotics, will be randomised to receive one of three treatment approaches: (1) immediate prescription for antibiotics; (2) immediate prescription for antibiotics plus a 7-day course of cranberry capsules and (3) cranberry capsules plus a delayed prescription for antibiotics to be used in case their symptoms do not get better, or get worse. Follow-up will be by daily rating of symptoms and recording of treatments used for 2 weeks in an online symptom diary. Interviews will be conducted with around 10-15 study participants, as well as with around 10-15 women who have experienced a UTI but have not been approached to take part in the study. Both groups will be asked about their experience of having a UTI, their thoughts on non-antibiotic treatments for UTIs and their thoughts on, or experience of, the feasibility trial. The primary objective is to assess the feasibility of undertaking a full trial in primary care of the effectiveness of cranberry extract to reduce antibiotic use for symptoms of acute uncomplicated UTI. The secondary objective is to conduct a preliminary assessment of the extent to which cranberry might reduce antibiotic use and symptom burden.
DISCUSSION


This feasibility study with embedded interviews will inform the planning and sample size calculation of an adequately powered trial to definitively determine whether cranberry helps to alleviate the symptoms of acute uncomplicated UTIs in women and whether it can safely reduce antibiotic use.
TRIAL REGISTRATION


ISRCTN registry, ID: 10399299. Registered on 24 January 2019.",2019,"Both groups will be asked about their experience of having a UTI, their thoughts on non-antibiotic treatments for UTIs and their thoughts on, or experience of, the feasibility trial.","['symptoms of acute uncomplicated UTI', '10-15 study participants, as well as with around 10-15 women who have experienced a UTI but have not been approached to take part in the study', '45 women consulting in primary care, with symptoms suggestive of an uncomplicated UTI for whom the practitioner would normally prescribe antibiotics']","['immediate prescription for antibiotics; (2) immediate prescription for antibiotics plus a 7-day course of cranberry capsules and (3) cranberry capsules plus a delayed prescription for antibiotics', 'cranberry extract']",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0936050', 'cui_str': 'Cranberry'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]",[],15.0,0.124622,"Both groups will be asked about their experience of having a UTI, their thoughts on non-antibiotic treatments for UTIs and their thoughts on, or experience of, the feasibility trial.","[{'ForeName': 'Oghenekome', 'Initials': 'O', 'LastName': 'Gbinigie', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. oghenekome.gbinigie@phc.ox.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boylan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Heneghan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, SO16 5ST, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}]",Trials,['10.1186/s13063-019-3860-z']
585,31870414,Rapid Access to Contrast-Enhanced spectral mammogRaphy in women recalled from breast cancer screening: the RACER trial study design.,"BACKGROUND


In the Dutch breast cancer screening program, women recalled with a BI-RADS 0 score are referred for additional imaging, while those with BI-RADS 4/5 scores are also directed to an outpatient breast clinic. Approximately six out of ten women are recalled without being diagnosed with a malignancy. However, these recalls require additional imaging and doctor visits, which result in patient anxiety and increased health care costs. Conventional types of imaging used for additional imaging are full-field digital mammography and tomosynthesis. Contrast-enhanced spectral mammography has proved to have higher sensitivity and specificity than conventional imaging in women recalled from screening. Therefore, the aim is to study if CESM instead of conventional imaging is a more accurate, patient-friendly, and cost-effective strategy in the work-up of women recalled from breast cancer screening.
METHODS


This prospective, multicenter, randomized controlled trial will be conducted at four centers and will include 528 patients recalled for suspicious breast lesions from the Dutch breast cancer screening program. Participants are randomized in two groups: (1) standard care using conventional breast imaging techniques as initial imaging after recall versus (2) work-up primarily based on CESM. Written informed consent will be collected prior to study inclusion. The primary outcome is the diagnostic accuracy for detection of breast cancer. Secondary outcomes are numbers of additional diagnostic exams, days until final diagnosis, health care costs, and experienced patient anxiety.
DISCUSSION


Based on previously published retrospective studies, we expect to demonstrate in this prospective multicenter randomized controlled trial, that using CESM as a primary work-up tool in women recalled from breast cancer screening is a more accurate, cost-effective, and patient-friendly strategy.
TRIAL REGISTRATION


Netherlands Trial Register, NL6413/NTR6589. Registered on 6 July, 2017.",2019,Participants are randomized in two groups: (1) standard care using conventional breast imaging techniques as initial imaging after recall versus (2) work-up primarily based on CESM.,"['women recalled from breast cancer screening', '528 patients recalled for suspicious breast lesions from the Dutch breast cancer screening program']","['CESM', 'Contrast-Enhanced spectral mammogRaphy', 'standard care using conventional breast imaging techniques as initial imaging after recall versus (2) work-up primarily based on CESM']","['numbers of additional diagnostic exams, days until final diagnosis, health care costs, and experienced patient anxiety', 'diagnostic accuracy for detection of breast cancer', 'patient anxiety and increased health care costs']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C4511913', 'cui_str': 'Contrast enhanced spectral mammography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0079595', 'cui_str': 'Imaging technique (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",528.0,0.123832,Participants are randomized in two groups: (1) standard care using conventional breast imaging techniques as initial imaging after recall versus (2) work-up primarily based on CESM.,"[{'ForeName': 'L M F H', 'Initials': 'LMFH', 'LastName': 'Neeter', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.'}, {'ForeName': 'I P L', 'Initials': 'IPL', 'LastName': 'Houben', 'Affiliation': 'Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'T J A', 'Initials': 'TJA', 'LastName': 'Van Nijnatten', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Pijnappel', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frotscher', 'Affiliation': 'Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Osinga-de Jong', 'Affiliation': 'Department of Medical Imaging, Zuyderland Medical Center, Sittard-Geleen, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sanders', 'Affiliation': 'Department of Radiology, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Van Dalen', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'H P J', 'Initials': 'HPJ', 'LastName': 'Raat', 'Affiliation': 'Department of Radiology, Laurentius Hospital, Roermond, the Netherlands.'}, {'ForeName': 'B A B', 'Initials': 'BAB', 'LastName': 'Essers', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Smidt', 'Affiliation': 'GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'M B I', 'Initials': 'MBI', 'LastName': 'Lobbes', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands. mbi.lobbes@gmail.com.'}]",Trials,['10.1186/s13063-019-3867-5']
586,31829767,Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12-15 years: end-of-study results from a community-randomized study up to 6.5 years.,"This manuscript discloses end-of-study safety data of a community-randomized controlled trial in Finland (NCT00534638), assessing the effectiveness of two vaccination strategies (gender-neutral versus females only) using the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine. The total vaccination cohort included 32,175 adolescents aged 12-15 y at vaccination of whom 14,837 received the AS04-HPV-16/18 vaccine and 17,338 received the hepatitis-B virus vaccine (control). Spontaneous reporting of serious adverse events (SAEs) combined with surveillance using nation-wide health registries showed an acceptable safety profile of the AS04-HPV-16/18 vaccine. During the study period (up to 6.5 y), the incidences (per 100,000 person-years) of reported SAEs considered as possibly related to vaccination were 39.1 (95% confidence interval [CI]: 25.3-57.7) and 39.8 (95%CI: 26.8-56.8) in the HPV and control groups, respectively. The most frequently reported new-onset autoimmune diseases (NOADs) were ulcerative colitis (incidence rates of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn's disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9). Of 1,344 pregnancies reported (777 and 567 in the HPV and control groups, respectively), most resulted in elective termination (58.4% and 58.6%), birth of a live infant (32.7% and 32.3%), or in spontaneous abortion (8.0% and 7.9%). No major, registered congenital anomalies were identified. The incidence rates of NOADs and pregnancy outcomes were generally balanced between groups. No specific safety signals were identified in the population-based health registry surveillance. Plain Language Summary What is the context? ● Since first licensure in 2007 of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine ( Cervarix , GSK), large quantity of safety data has been collected and confirmed its safety profile. This study provides further unique, population-based safety data from vaccinated Finnish adolescents monitored via health registries up to 6.5 y of follow-up. What is new? ● The vaccine has shown an acceptable safety profile in girls and boys. The risk of new-onset autoimmune diseases (NOADs) was similar between the HPV vaccine group and the control group and in line with the expectations for the studied population. ● The study supports that safety surveillance via national health registries is in general more sensitive than the conventional safety reporting, notably for monitoring specific chronic diseases, e.g. autoimmune disorders. What is the impact? ● This study highlights the importance of health registries in long-term vaccination safety surveillance. The population-based safety data reported in this study further support the routine administration of the HPV vaccine to girls and boys.",2020,The risk of new-onset autoimmune diseases (NOADs) was similar between the HPV vaccine group and the control group and in line with the expectations for the studied population.,"['vaccinated Finnish adolescents monitored via health registries up to 6.5 y of follow-up', ""of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn's disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9"", 'adolescents aged 12-15 years', '32,175 adolescents aged 12-15 y at vaccination of whom 14,837 received the', '1,344 pregnancies reported ', 'girls and boys']","['AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine', 'AS04-HPV-16/18 vaccine', 'HPV vaccine', 'hepatitis-B virus vaccine (control', 'AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine']","['incidence rates of NOADs and pregnancy outcomes', 'birth of a live infant', 'elective termination', 'risk of new-onset autoimmune diseases (NOADs', 'spontaneous abortion', 'ulcerative colitis (incidence rates']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C3495559', 'cui_str': 'Arthritis, Juvenile Chronic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]",,0.240165,The risk of new-onset autoimmune diseases (NOADs) was similar between the HPV vaccine group and the control group and in line with the expectations for the studied population.,"[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK , Wavre, Belgium.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'Sexual Health Clinic, Family Federation of Finland , Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Faculty of Social Sciences, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Faculty of Social Sciences, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Zima', 'Affiliation': 'EMD Serono , Billerica, MA, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Damaso', 'Affiliation': 'GSK , Wavre, Belgium.'}, {'ForeName': 'Maaria', 'Initials': 'M', 'LastName': 'Soila', 'Affiliation': 'GSK , Espoo, Finland.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dubin', 'Affiliation': 'Takeda Pharmaceuticals , Zurich, Switzerland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Faculty of Social Sciences, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK , Wavre, Belgium.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1692557']
587,31118761,Effect of ultrasound-guided peripheral nerve blocks of the abdominal wall on pain relief after laparoscopic cholecystectomy.,"Purpose:  The aim of this study was to compare the effect of an ultrasound-guided transversus abdominis plane block (TAPB) and rectus sheath block (RSB) combination, an ultrasound-guided posterior TAP block combined with the local anesthetic infiltration (LAI) and LAI alone on pain relief after laparoscopic cholecystectomy (LC).  Patients and methods:  One hundred eighty patients who were American Society of Anesthesiologists class Ι or Π were included in this randomized, double-blind, non-inferiority study. All patients underwent three-port LC and were divided into 3 groups. The LAI group had ropivacaine mixed with dexmedetomidine injected around the trocar entrance site preoperatively. The TL group underwent ultrasound-guided posterior TAPB combined with LAI, and the TR group underwent ultrasound-guided TAPB combined with RSB. Postoperative pain was evaluated at the first, 4th, 8th, 24th, and 48th hours. If the visual analogue scale (VAS) score (including incisional pain, visceral pain or shoulder pain) was >3, intravenous dezocine (0.05 mg/kg) was injected slowly. Sleep quality, total consumption of dezocine and time to unassisted walking were recorded. The Global Satisfaction Score (GSS) for analgesia was also assessed within 48 hrs.  Results:  No difference was found in sleep quality, time to unassisted walking, or requirement for dezocine. We also found no difference in VAS scores at each time point within 48 hrs after LC among the 3 groups, but the GSS for analgesia in the LAI group was significantly increased within 48 hrs compared with the other two groups.  Conclusion:  Ultrasound-guided peripheral nerve blocks of the abdominal wall can significantly relieve postoperative pain in patients undergoing LC; however, patients receiving LAI expressed more satisfaction than patients in whom other methods were used. LAI is an easy and effective method that can be recommended for routine clinical practice in LC patients who are not converted to an open procedure.",2019,"No difference was found in sleep quality, time to unassisted walking, or requirement for dezocine.","['LC patients who are not converted to an open procedure', 'after laparoscopic cholecystectomy (LC', 'class Ι or Π', 'One hundred eighty patients who were American Society of Anesthesiologists', 'patients undergoing LC', 'after laparoscopic cholecystectomy']","['dezocine', 'ultrasound-guided peripheral nerve blocks', 'ultrasound-guided transversus abdominis plane block (TAPB) and rectus sheath block (RSB) combination, an ultrasound-guided posterior TAP block combined with the local anesthetic infiltration (LAI) and LAI alone', 'ropivacaine', 'dexmedetomidine', 'ultrasound-guided posterior TAPB combined with LAI, and the TR group underwent ultrasound-guided TAPB combined with RSB']","['postoperative pain', 'GSS for analgesia', 'Postoperative pain', 'VAS scores', 'sleep quality, time to unassisted walking, or requirement for dezocine', 'Sleep quality, total consumption of dezocine and time to unassisted walking', 'visual analogue scale (VAS) score (including incisional pain, visceral pain or shoulder pain', 'pain relief', 'Global Satisfaction Score (GSS) for analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}, {'cui': 'C0443021', 'cui_str': 'Lai (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0167914', 'cui_str': 'TAPB-H'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234245', 'cui_str': 'Visceral Pain'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",180.0,0.113348,"No difference was found in sleep quality, time to unassisted walking, or requirement for dezocine.","[{'ForeName': 'Lining', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Hefei, Anhui Medical University, Hefei 230061, People's Republic of China.""}, {'ForeName': 'Liangchun', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Anhui Provincial People's Armed Police General Hospital, Hefei 230041, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Hefei, Anhui Medical University, Hefei 230061, People's Republic of China.""}, {'ForeName': 'Chunshan', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Hefei, Anhui Medical University, Hefei 230061, People's Republic of China.""}, {'ForeName': 'Junma', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Hefei, Anhui Medical University, Hefei 230061, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S203721']
588,31860800,Early Progressive Maxillary Changes with Nasoalveolar Molding: Randomized Controlled Clinical Trial.,"OBJECTIVES


Quantitative assessment of 3-dimensional progressive changes of the maxillary geometry in unilateral cleft lip palate (UCLP) with and without nasoalveolar molding (NAM).
METHODS


The study was designed as a prospective 2-arm randomized controlled clinical trial conducted in parallel. Forty infants with nonsyndromic UCLP were randomly assigned into a NAM-treated group (n = 20) and non-NAM treated group (n = 20). A total of 120 laser-scanned maxillary casts were collected and blindly analyzed via a modified algorithm at T0 (initial visit; baseline), T1 (after 3 wk; first interval), and T2 (after 6 wk; second interval). The main outcome measures were the amount and rate of cleft gap changes, the midline position, and the transverse, sagittal, and vertical growth through intervals.
RESULTS


More than 50% of the cleft gap (56.42%; P < 0.001) was reduced in the first 3 wk of alveolar molding (AM). The end point of the AM was obtained in 6 wk (86.25%; P < 0.001); then, the kinks of the greater segment were noticed. The AM effect decreased as far as posterior; the anterior arch width reduced slightly (1.23%; P < 0.001), while the middle and posterior arches increased slightly (P > 0.999 and P = 0.288, respectively). The posterior arch width was the least changing and was considered a baseline, while the anterior was the pivot of the segment rotation. Both groups showed different patterns of segment rotation and sagittal growth. The non-NAM treated group showed a slight increase in cleft gap length, arch width, and midline position.
CONCLUSION


Based on this study, it was concluded that the NAM treatment is effective in minimizing cleft severity and realigning maxillary segments without the deterioration of the transverse and vertical arch growth. Near follow-up visits are recommended to monitor the rapid gap reduction within the first 3 wk. Further trials are recommended to compare the outcomes regarding the sagittal growth to reference values (ClinicalTrials.gov NCT03029195).
KNOWLEDGE TRANSFER STATEMENT


The results of this study will help clinicians understand nasoalveolar molding biomechanics that may improve the treatment outcomes for patients with unilateral cleft lip and palate. The trial data can be a valuable guide to the qualitative and quantitative predictive virtual molding in computer aided design-simulated nasoalveolar molding therapy. The modified algorithm can be used by researchers to quantify the rate, the sequence, and the direction of the maxillary segments movement in unilateral cleft lip and palate.",2020,More than 50% of the cleft gap (56.42%; P < 0.001) was reduced in the first 3 wk of alveolar molding (AM).,"['Forty infants with nonsyndromic UCLP', 'unilateral cleft lip palate (UCLP) with and without nasoalveolar molding (NAM', 'Early Progressive Maxillary Changes with Nasoalveolar Molding', 'patients with unilateral cleft lip and palate']","['NAM-treated group (n = 20) and non-NAM', 'NAM']","['cleft gap length, arch width, and midline position', 'segment rotation and sagittal growth', 'amount and rate of cleft gap changes, the midline position, and the transverse, sagittal, and vertical growth through intervals']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",120.0,0.0693553,More than 50% of the cleft gap (56.42%; P < 0.001) was reduced in the first 3 wk of alveolar molding (AM).,"[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Saad', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fata', 'Affiliation': 'Department of Oral Medicine, Periodontology, Oral Diagnosis, and Radiology, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Farouk', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'A M A', 'Initials': 'AMA', 'LastName': 'Habib', 'Affiliation': 'Department of Maxillofacial and Plastic Surgery, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gad', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Tayel', 'Affiliation': 'Department of Electrical Engineering, Faculty of Engineering, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Marei', 'Affiliation': 'Department of Prosthodontics, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}]",JDR clinical and translational research,['10.1177/2380084419887336']
589,31881910,"Examining the effects of a high-protein total diet replacement on energy metabolism, metabolic blood markers, and appetite sensations in healthy adults: protocol for two complementary, randomized, controlled, crossover trials.","BACKGROUND


High-protein diets and total diet replacements are becoming increasingly popular for weight regulation; however, further research is needed to elucidate their impact on the physiology of body weight regulation. The aim of this inpatient metabolic balance study is to compare the impact of a high-protein total diet replacement versus a control diet (North American) on energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers and appetite sensations in healthy adults.
METHODS


Two randomized, controlled, cross-over clinical trials conducted separately in men and women will be conducted. In each trial, participants will be allocated to two isocaloric arms: a) Control diet: 55% carbohydrate, 15% protein, and 30% fat; b) High-protein total diet replacement: 35% of carbohydrate, 40% protein, and 25% fat. They will receive the prescribed diets for 32 h while inside the whole-body calorimetry unit. Diets will be designed to ensure participants are in energy balance. The following physiological changes will be compared between groups: energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers, and appetite sensations. Body composition will be assessed at baseline using dual-energy X-ray absorptiometry.
DISCUSSION


This will be the first inpatient metabolic balance study examining the impact of a high-protein total diet replacement on energy metabolism, metabolic blood markers and appetite sensations in healthy young adults (of both sexes) using a whole-body calorimetry unit. Results of this clinical trial can ultimately be used to develop strategies to optimize high-protein diet interventions and weight management.
TRIAL REGISTRATION


ClinicalTrials.gov Identifiers: NCT02811276 (registered on 16 June 2016) and NCT03565510 (registered on 11 June 2018).
PROTOCOL VERSION


NCT02811276: version 10 (2 March 2018); NCT03565510: version 3 (28 September 2018).",2019,"The following physiological changes will be compared between groups: energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers, and appetite sensations.","['men and women will be conducted', 'healthy young adults (of both sexes', 'healthy adults']","['high-protein total diet replacement versus a control diet (North American', 'Control diet: 55% carbohydrate, 15% protein, and 30% fat; b) High-protein total diet replacement: 35% of carbohydrate, 40% protein, and 25% fat', 'high-protein total diet replacement']","['Body composition', 'energy metabolism, metabolic blood markers, and appetite sensations', 'energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers, and appetite sensations', 'energy metabolism, metabolic blood markers and appetite sensations', 'energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers and appetite sensations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0005768'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0528984,"The following physiological changes will be compared between groups: energy expenditure, macronutrient oxidation rates and balances, metabolic blood markers, and appetite sensations.","[{'ForeName': 'Camila L P', 'Initials': 'CLP', 'LastName': 'Oliveira', 'Affiliation': 'Human Nutrition Research Unit, Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Normand G', 'Initials': 'NG', 'LastName': 'Boulé', 'Affiliation': 'Faculty of Kinesiology, Sport & Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Arya M', 'Initials': 'AM', 'LastName': 'Sharma', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Elliott', 'Affiliation': 'Human Nutrition Research Unit, Department of Agricultural, Food & Nutritional Science and Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': 'School of Life Sciences, Division of Physiology, Pharmacology and Neuroscience, University of Nottingham, Nottingham, England, UK.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Medical Oncology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Aloys', 'Initials': 'A', 'LastName': 'Berg', 'Affiliation': 'Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food and Nutritional Science - Division of Human Nutrition, University of Alberta, 4-002 Li Ka Shing Centre for Health Research Innovation (Office 2-021E), Edmonton, Alberta, T6G 2E1, Canada. carla.prado@ualberta.ca.'}]",Trials,['10.1186/s13063-019-3950-y']
590,31881911,Manual therapy as a prophylactic treatment for migraine: design of a randomized controlled trial.,"BACKGROUND


People with migraine often experience disability with serious consequences for their social life and work productivity. The pharmacological prophylactic management of migraine is effective in reducing migraine attacks. However, many people are reluctant to use daily prophylactic medication, leading to a demand for non-pharmacological treatment options. We present the design for and discuss the feasibility of a pragmatic, randomized controlled trial on the effectiveness of a multimodal manual therapy (MT) treatment compared to usual care by the general practitioner (GP) for the prophylactic treatment of migraine.
METHODS


Eligible participants will be recruited in primary care using the International Classification of Headache Disorders III criteria for migraine of the International Headache Society. Participants will be randomized to either multimodal MT treatment or usual care provided by the GP. GPs will be asked to treat the usual care group according to the Dutch GP guideline for headache. The multimodal MT intervention will include manual pressure techniques, neck muscle-strength exercises and mobilization of the cervical and thoracic spine. The trial will consist of a 12-week treatment period and follow-up measurements at 12, 26 and 52 weeks. The primary outcome measure is the number of migraine days per 4 weeks, assessed with a headache diary. Secondary outcome measures are the number of migraine attacks, medication use, disability due to headache, headache intensity, number of participants reporting a 50% migraine reduction, measurement of cervical pressure pain thresholds, presence of allodynia, endurance of cervical flexor muscles, days of absence of work and global perceived effect.
DISCUSSION


The results of the trial will show whether a multimodal MT intervention is an effective non-pharmacological treatment option for people with migraine.
TRIAL REGISTRATION


Dutch Trial Register, NL7504. Registered on 7 February 2019.",2019,"We present the design for and discuss the feasibility of a pragmatic, randomized controlled trial on the effectiveness of a multimodal manual therapy (MT) treatment compared to usual care by the general practitioner (GP) for the prophylactic treatment of migraine.
","['migraine', 'people with migraine', 'Eligible participants will be recruited in primary care using the International Classification of Headache Disorders III criteria for migraine of the International Headache Society']","['multimodal MT intervention', 'multimodal MT treatment or usual care provided by the GP', 'Manual therapy', 'multimodal manual therapy (MT']","['number of migraine attacks, medication use, disability due to headache, headache intensity, number of participants reporting a 50% migraine reduction, measurement of cervical pressure pain thresholds, presence of allodynia, endurance of cervical flexor muscles, days of absence of work and global perceived effect', 'number of migraine days per 4 weeks, assessed with a headache diary']","[{'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0393735', 'cui_str': 'Cephalgia Syndromes'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",,0.0929754,"We present the design for and discuss the feasibility of a pragmatic, randomized controlled trial on the effectiveness of a multimodal manual therapy (MT) treatment compared to usual care by the general practitioner (GP) for the prophylactic treatment of migraine.
","[{'ForeName': 'Andreas Leonard', 'Initials': 'AL', 'LastName': 'Amons', 'Affiliation': 'Headache Centre at Healthcare Centre Haarlemmermeer, Waddenweg 1, 2134XL, Hoofddorp, The Netherlands. a.amons@amsterdamumc.nl.'}, {'ForeName': 'Rene Franciscus', 'Initials': 'RF', 'LastName': 'Castien', 'Affiliation': 'Headache Centre at Healthcare Centre Haarlemmermeer, Waddenweg 1, 2134XL, Hoofddorp, The Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centres (location VUmc), Van der Boechorststraat 7, 1018BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, 2610, Wilrijk, Belgium.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centres (location VUmc), Van der Boechorststraat 7, 1018BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Henriëtte Eveline', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam University Medical Centres (location VUmc), Van der Boechorststraat 7, 1018BT, Amsterdam, The Netherlands.'}]",Trials,['10.1186/s13063-019-3937-8']
591,31669455,Is Ultrasonic Bone Scalpel Useful in Le Fort I Osteotomy?,"PURPOSE


Safety and precision are 2 main goals in research to improve bone cutting in maxillofacial surgery. The aim of this prospective clinical study was to analyze the outcomes using an ultrasonic bone scalpel versus a piezoelectric surgical device and the conventional technique in a Le Fort I osteotomy.
MATERIALS AND METHODS


We designed a prospective, randomized, single-blind cohort study. The predictor variables were the devices used to perform the Le Fort I osteotomy, divided into 3 groups: 1) ultrasonic bone scalpel (BoneScalpel; Misonix, Farmingdale, NY), 2) piezoelectric surgical device, and 3) conventional technique (Lindeman burr and reciprocal saw). The primary outcome of the study was cutting time, whereas secondary outcomes were length of the procedure, total blood loss, intraoperative complications, and postoperative edema. Other variables of interest were age and gender. Data were analyzed using 1-way analysis of variance and the Kruskal-Wallis test.
RESULTS


The study sample was composed of 34 patients with a mean age of 21.5 years, and 63.3% of patients were women. The mean cutting time (P < .001) and length of the procedure (P = .012) were significantly shorter with the bone scalpel than with the other types of surgery. The ultrasonic bone scalpel showed a significant reduction in intraoperative blood loss of up to 45% compared with the piezoelectric surgical device and the conventional technique (P = .038).
CONCLUSIONS


The results of this study suggest that the ultrasonic bone scalpel is an effective ultrasonic bone-cutting instrument in a Le Fort I osteotomy as evidenced by the significant decrease in the cutting time, intraoperative blood loss, and postoperative edema compared with the other techniques.",2020,The mean cutting time (P < .001) and length of the procedure (P = .012) were significantly shorter with the bone scalpel than with the other types of surgery.,"['34 patients with a mean age of 21.5\xa0years, and 63.3% of patients were women']","['ultrasonic bone scalpel (BoneScalpel; Misonix, Farmingdale, NY), 2) piezoelectric surgical device, and 3) conventional technique (Lindeman burr and reciprocal saw', 'ultrasonic bone scalpel', 'ultrasonic bone scalpel versus a piezoelectric surgical device and the conventional technique']","['mean cutting time', 'length of the procedure, total blood loss, intraoperative complications, and postoperative edema', 'cutting time, intraoperative blood loss, and postoperative edema', 'intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.037364,The mean cutting time (P < .001) and length of the procedure (P = .012) were significantly shorter with the bone scalpel than with the other types of surgery.,"[{'ForeName': 'Ahmet Emin', 'Initials': 'AE', 'LastName': 'Demirbas', 'Affiliation': 'Assistant Professor and Department Head, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University, Melikgazi, Turkey. Electronic address: aedemirbas@erciyes.edu.tr.'}, {'ForeName': 'Suheyb', 'Initials': 'S', 'LastName': 'Bilge', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University, Melikgazi, Turkey.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Celebi', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University, Melikgazi, Turkey.'}, {'ForeName': 'Nükhet', 'Initials': 'N', 'LastName': 'Kütük', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Alkan', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.021']
592,31868978,Gross motor adaptation benefits from sleep after training.,"Sleep has been shown to facilitate the consolidation of newly acquired motor memories. However, the role of sleep in gross motor learning, especially in motor adaptation, is less clear. Thus, we investigated the effects of nocturnal sleep on the performance of a gross motor adaptation task, i.e. riding an inverse steering bicycle. Twenty-six male participants (M = 24.19, SD = 3.70 years) were randomly assigned to a PM-AM-PM (n = 13) or an AM-PM-AM (n = 13) group, i.e. they trained in the evening/morning and were re-tested the next morning/evening and the following evening/morning (PM-AM-PM/AM-PM-AM group) so that every participant spent one sleep as well as one wake interval between the three test sessions. Inverse cycling performance was assessed by speed (riding time) and accuracy (standard deviation of steering angle) measures. Behavioural results showed that in the PM-AM-PM group a night of sleep right after training stabilized performance (accuracy and speed) and was further improved over the subsequent wake interval. In the AM-PM-AM group, a significant performance deterioration after the initial wake interval was followed by the restoration of subjects' performance levels from right after training when a full night of sleep was granted. Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"". Our results demonstrate that sleep facilitates the consolidation of gross motor adaptation, thus adding further insights to the role of sleep for tasks with real-life relevance.",2020,"Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"".","['3.70\xa0years', 'Twenty-six male participants (M\xa0=\xa024.19, SD\xa0']",['PM-AM-PM (n\xa0=\xa013) or an AM-PM-AM'],"['Inverse cycling performance', 'speed (riding time) and accuracy (standard deviation of steering angle) measures']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0553654', 'cui_str': 'Does steer (finding)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",26.0,0.0137131,"Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"".","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Bothe', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Hirschauer', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Wiesinger', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Janina M', 'Initials': 'JM', 'LastName': 'Edfelder', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Hoedlmoser', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Birklbauer', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}]",Journal of sleep research,['10.1111/jsr.12961']
593,31882016,"Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.","BACKGROUND


Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP.
METHODS


This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20 min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed.
DISCUSSION


The results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation.
TRIAL REGISTRATION


Clinical Research Information Service, KCT0002998. Registered on 12 July 2018.",2019,The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks.,"['chronic low back pain (CLBP', 'chronic low back pain']","['placebo', 'acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks', 'adjuvant herbal medicine treatment, Palmijihwang-hwan', 'acupuncture treatment at 11 local and 4 distal acupuncture']","['change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis', 'Efficacy, safety, and cost-effectiveness analysis']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]",4.0,0.221619,The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks.,"[{'ForeName': 'Won-Suk', 'Initials': 'WS', 'LastName': 'Sung', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do, 13601, South Korea.'}, {'ForeName': 'Sae-Rom', 'Initials': 'SR', 'LastName': 'Jeon', 'Affiliation': 'Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Ye-Jin', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Tae-Hun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Clinical Trial Center, Korean Medicine Hospital, Department of Korean Medicine, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Seungwon', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Clinical Trial Center, Korean Medicine Hospital, Department of Korean Medicine, Kyung Hee University, Seoul, South Korea.'}, {'ForeName': 'Hyun-Jong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Gyeongsan-si, Gyeongsangbuk-do, South Korea.'}, {'ForeName': 'Byung-Kwan', 'Initials': 'BK', 'LastName': 'Seo', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, South Korea.'}, {'ForeName': 'Yeon-Cheol', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, South Korea.'}, {'ForeName': 'Eun-Jung', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do, 13601, South Korea. hanijjung@naver.com.'}, {'ForeName': 'Dong-Woo', 'Initials': 'DW', 'LastName': 'Nam', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, South Korea. hanisanam@daum.net.'}]",Trials,['10.1186/s13063-019-3776-7']
594,31882017,Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol.,"BACKGROUND


Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments' outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS.
METHODS


We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care.
DISCUSSION


Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.",2019,We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up.,"['adults with MS and chronic pain', 'chronic pain in multiple sclerosis', 'individuals with chronic pain and MS']","['Mindfulness-based cognitive therapy and cognitive behavioral therapy', 'MBCT or CBT', 'Mindfulness-based cognitive therapy (MBCT', 'Cognitive-behavioral therapy (CBT']","['Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep', 'average pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",,0.0851141,We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up.,"[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA, 98104, USA. ehde@uw.edu.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Alschuler', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA, 98104, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'School of Psychology, University of Queensland, 330 McElwain Building, Brisbane, Queensland, 4072, Australia.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA, 98104, USA.'}, {'ForeName': 'Makena L', 'Initials': 'ML', 'LastName': 'Kaylor', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA, 98104, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Altman', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA, 98104, USA.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, School of Medicine, University of Washington, 325 9th Ave, Box 359612, Seattle, WA, 98104, USA.'}]",Trials,['10.1186/s13063-019-3761-1']
595,31885193,SuperPATH Minimally Invasive Approach to Total Hip Arthroplasty of Femoral Neck Fractures in the Elderly: Preliminary Clinical Results.,"OBJECTIVE


To investigate the clinical efficacy and advantages of the SuperPATH minimally invasive approach to total hip arthroplasty in the treatment of femoral neck fractures in the elderly.
METHODS


From January 2016 to September 2018, 110 cases of elderly patients with femoral neck fractures were included in the present study. According to the method of operation, the patients were divided into two groups for comparison. There were 55 cases of the SuperPATH minimally invasive approach to total hip arthroplasty and 55 cases with the conventional posterolateral approach to total hip arthroplasty. The operation time, the length of incision, the amount of operative blood loss, the hospitalization time, and the hospitalization cost were compared between the two groups. The position of total hip prosthesis was observed during the follow-up period. All patients were evaluated for the degree of hip joint pain and the function of the hip joint using the visual analog score (VAS) and the Harris score at 1 week, 1 month, 3 months, 6 months, and 12 months after the operation.
RESULTS


All patients were followed up for at least 12 months. The operation time was 108.58 ± 15.87 min in the SuperPATH group and 102.51 ± 19.61 min in the conventional group. The length of incision was 6.65 ± 1.53 cm in the SuperPATH group and 17.08 ± 1.40 cm in the conventional group. The amount of operative blood loss was 147.51 ± 28.84 mL in the SuperPATH group and 170.22 ± 25.34 mL in the conventional group. The hospitalization time was 10.05 ± 2.52 days in the SuperPATH group and 13.36 ± 3.39 days in the conventional group. The hospitalization cost was 6871.78 ± 141.63 dollars in the SuperPATH group and 7791.09 ± 184.88 dollars in the conventional group. Compared with the conventional group, the SuperPATH group had shorter incision length, less blood loss, shorter hospitalization time, and lower hospitalization cost. There was significant difference between the two groups (P < 0.05). In the two groups, there were no complications such as infection, lower extremity venous thrombosis, prosthesis loosening, periprosthetic fracture, and dislocation during the follow-up period. The VAS score was 4.45 ± 0.94 in the SuperPATH group and 4.89 ± 0.79 in the conventional group at 1 week after the operation. There was significant difference between the two groups (P < 0.05). The Harris score was 75.36 ± 3.36 and 80.25 ± 3.09 in the SuperPATH group and 68.80 ± 3.25 and 77.35 ± 3.77 in the conventional group at 1 week and 1 month after the operation, respectively. There was significant difference between the two groups (P < 0.05). In the analysis of the operation time, the VAS score at 1 month, 3 months, 6 months, and 12 months after the operation, and the Harris score at 3 months, 6 months, and 12 months after surgery, there was no significant difference between the two groups (P > 0.05).
CONCLUSION


The SuperPATH minimally invasive approach to total hip arthroplasty is an ideal method for the treatment of femoral neck fractures in the elderly. This method has the advantages of the relatively simple operation, short incision, less blood loss, and less trauma. The patients had short hospitalization times, low hospitalization costs, and good recovery of hip joint function.",2020,"In the two groups, there were no complications such as infection, lower extremity venous thrombosis, prosthesis loosening, periprosthetic fracture, and dislocation during the follow-up period.","['From January 2016 to September 2018, 110 cases of elderly patients with femoral neck fractures', 'femoral neck fractures in the elderly', 'Total Hip Arthroplasty of Femoral Neck Fractures in the Elderly']","['SuperPATH minimally invasive approach to total hip arthroplasty', 'SuperPATH']","['complications such as infection, lower extremity venous thrombosis, prosthesis loosening, periprosthetic fracture, and dislocation', 'position of total hip prosthesis', 'degree of hip joint pain and the function of the hip joint using the visual analog score (VAS) and the Harris score', 'short hospitalization times, low hospitalization costs, and good recovery of hip joint function', 'hospitalization time', 'operative blood loss', 'shorter incision length, less blood loss, shorter hospitalization time, and lower hospitalization cost', 'length of incision', 'operation time, the length of incision, the amount of operative blood loss, the hospitalization time, and the hospitalization cost', 'operation time', 'hospitalization cost', 'VAS score']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0033587', 'cui_str': 'Prosthesis Loosening'}, {'cui': 'C2609162', 'cui_str': 'Periprosthetic Fractures'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019560', 'cui_str': 'Hip Prosthesis'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",,0.0140591,"In the two groups, there were no complications such as infection, lower extremity venous thrombosis, prosthesis loosening, periprosthetic fracture, and dislocation during the follow-up period.","[{'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wang', 'Affiliation': 'Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Lan', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Zheng-Xia', 'Initials': 'ZX', 'LastName': 'Hu', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Kai-Nan', 'Initials': 'KN', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Chengdu University, Chengdu, China.'}, {'ForeName': 'Zheng-Hao', 'Initials': 'ZH', 'LastName': 'Wang', 'Affiliation': 'Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Long', 'Affiliation': 'Zunyi Medical University, Zunyi, China.'}]",Orthopaedic surgery,['10.1111/os.12584']
596,31881916,The BrainACT study: acceptance and commitment therapy for depressive and anxiety symptoms following acquired brain injury: study protocol for a randomized controlled trial.,"BACKGROUND


Following an acquired brain injury, individuals frequently experience anxiety and/or depressive symptoms. However, current treatments for these symptoms are not very effective. A promising treatment is acceptance and commitment therapy (ACT), which is a third-wave behavioural therapy. The primary goal of this therapy is not to reduce symptoms, but to improve psychological flexibility and general well-being, which may be accompanied by a reduction in symptom severity. The aim of this study is to investigate the effectiveness of an adapted ACT intervention (BrainACT) in people with acquired brain injury who experience anxiety and/or depressive symptoms.
METHODS


The study is a multicenter, randomized, controlled, two-arm parallel trial. In total, 94 patients who survive a stroke or traumatic brain injury will be randomized into an ACT or control (i.e. psycho-education and relaxation) intervention. The primary outcome measures are the Hospital Anxiety and Depression Scale and the Depression Anxiety Stress Scale. Outcomes will be assessed by trained assessors, blinded to treatment condition, pre-treatment, during treatment, post-treatment, and at 7 and 12 months.
DISCUSSION


This study will contribute to the existing knowledge on how to treat psychological distress following acquired brain injury. If effective, BrainACT could be implemented in clinical practice and potentially help a large number of patients with acquired brain injury.
TRIAL REGISTRATION


Dutch Trial Register, NL691, NTR 7111. Registered on 26 March 2018. https://www.trialregister.nl/trial/6916.",2019,"If effective, BrainACT could be implemented in clinical practice and potentially help a large number of patients with acquired brain injury.
","['patients with acquired brain injury', '94 patients who survive a stroke or traumatic brain injury', 'people with acquired brain injury who experience anxiety and/or depressive symptoms', 'depressive and anxiety symptoms following acquired brain injury']","['ACT or control (i.e. psycho-education and relaxation) intervention', 'BrainACT', 'adapted ACT intervention (BrainACT']","['psychological flexibility', 'Hospital Anxiety and Depression Scale and the Depression Anxiety Stress Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",94.0,0.222467,"If effective, BrainACT could be implemented in clinical practice and potentially help a large number of patients with acquired brain injury.
","[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Rauwenhoff', 'Affiliation': 'School for Mental Health and Neuroscience, Department of Psychiatry and Psychology, Maastricht University Medical Centre, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.'}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bol', 'Affiliation': 'Department of Clinical and Medical Psychology, Zuyderland Medical Centre, P.O. Box 5500, 6130 MB, Sittard, The Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Van Heugten', 'Affiliation': 'School for Mental Health and Neuroscience, Department of Psychiatry and Psychology, Maastricht University Medical Centre, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. caroline.vanheugten@maastrichtuniversity.nl.'}]",Trials,['10.1186/s13063-019-3952-9']
597,31881986,"The effect of daily consumption of different doses of fortified Lavash bread versus plain bread on serum vitamin-D status, body composition, metabolic and inflammatory biomarkers, and gut microbiota in apparently healthy adult: study protocol of a randomized clinical trial.","BACKGROUND


Due to the high prevalence of vitamin-D deficiency worldwide and its health consequences, intervention studies at the community level are warranted. The present study has been conducted to evaluate the effectiveness of vitamin-D-fortified bread on serum vitamin-D levels, inflammatory and metabolic biomarkers, and gut microbiota composition in vitamin-D-deficient individuals.
METHODS/DESIGN


A double-blind, randomized controlled clinical trial is conducted on apparently healthy individuals with vitamin-D deficiency. The random allocation is done to divide participants into intervention groups including daily intake of vitamin-D-3-fortified bread (FB) with 500 IU/100 g bread (n = 30), FB with 1000 IU/100 g bread (n = 30), and 100 g plain bread (PD) (n = 30). At baseline and after 3 months of the intervention period, blood, stool, and urine samples are taken. Anthropometric measures, body composition, blood pressure, and dietary assessment are made. The gut microbiome composition is measured by the 16S rRNA approach. Data is analyzed by SPSS software version 21.
DISCUSSION


This study may partly explain for the first time the conflicting results from recent critical and systematic reviews regarding the role of vitamin D in microbiota composition.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials (IRCT), ID: IRCT20170812035642N3. Registered on 11 March 2018; http://www.irct.ir/user/trial/28134/view.",2019,"The present study has been conducted to evaluate the effectiveness of vitamin-D-fortified bread on serum vitamin-D levels, inflammatory and metabolic biomarkers, and gut microbiota composition in vitamin-D-deficient individuals.
","['apparently healthy individuals with vitamin-D deficiency', 'apparently healthy adult', 'vitamin-D-deficient individuals']","['vitamin-D-fortified bread', 'vitamin-D-3-fortified bread (FB', 'fortified Lavash bread versus plain bread']","['serum vitamin-D levels, inflammatory and metabolic biomarkers, and gut microbiota composition', 'serum vitamin-D status, body composition, metabolic and inflammatory biomarkers, and gut microbiota', 'Anthropometric measures, body composition, blood pressure, and dietary assessment']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.278838,"The present study has been conducted to evaluate the effectiveness of vitamin-D-fortified bread on serum vitamin-D levels, inflammatory and metabolic biomarkers, and gut microbiota composition in vitamin-D-deficient individuals.
","[{'ForeName': 'Hadith', 'Initials': 'H', 'LastName': 'Tangestani', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), No 44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran.'}, {'ForeName': 'Kurosh', 'Initials': 'K', 'LastName': 'Djafarian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Shab-Bidar', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), No 44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran. s_shabbidar@tums.ac.ir.'}]",Trials,['10.1186/s13063-019-3852-z']
598,31881987,Use of a smartphone app combined with gamification to increase the level of physical activity of adults and older adults: protocol of a sequential multiple assignment randomized trial.,"BACKGROUND


There is scientific evidence suggesting that app-based interventions targeted to increase the level of physical activity might be effective, although multicomponent interventions appear to be more effective than app-based interventions alone. Despite the motivating results, it remains unclear whether or not app-based interventions can increase the level of physical activity and cardiovascular health. Our study aims to investigate the effect of a smartphone app combined with gamification on the level of physical activity of adults and older adults. The specific aims are (1) to verify the effects of the intervention on cardiometabolic and cardiovascular health, lung function, and cardiorespiratory fitness; and (2) to verify the relationship between age group and the response rate.
METHODS/DESIGN


We will conduct a sequential multiple assignment randomized trial (SMART). The adaptive intervention protocol will last 6 months. After baseline assessments, participants will be randomized into one of three groups (group 1: app + tailored messages; group 2: app + tailored messages + gamification I; control group: physical activity counseling). For 12 weeks, we will record the average number of steps per day of participants from groups 1 and 2. At 6 weeks from initiation of recording, participants will be classified into responders and non-responders according to their increase in the average number of daily steps; all those considered as non-responders will be re-randomized, with the chance to participate in a third group - group 3: app + tailored messages + gamification II. Finally, at 12 weeks, participants will continue using the app but will no longer receive direct intervention from investigators. All participants will be reassessed at 3 and 6 months from baseline. Our pilot SMART will require 42 participants (14 per arm). Following the SMART pilot, we will calculate the sample size for the trial based on the variation of the average number of steps/day, including an up to 40% loss to follow-up and a less optimistic nonresponse rate of 65%.
DISCUSSION


To our knowledge, this will be the first trial with adaptive intervention to test the effectiveness of using a smartphone app to increase the level of physical activity of adults and older adults.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry: RBR-8xtc9c. Registered on 3 August 2018, http://www.ensaiosclinicos.gov.br; UTN number: U1111-1218-1092.",2019,Our study aims to investigate the effect of a smartphone app combined with gamification on the level of physical activity of adults and older adults.,"['42 participants (14 per arm', 'adults and older adults']","['app + tailored messages + gamification II', 'app + tailored messages; group 2: app + tailored messages + gamification I; control group: physical activity counseling', 'smartphone app combined with gamification']","['optimistic nonresponse rate', 'level of physical activity and cardiovascular health', 'cardiometabolic and cardiovascular health, lung function, and cardiorespiratory fitness', 'level of physical activity']","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0564470', 'cui_str': 'Optimistic (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",42.0,0.0618663,Our study aims to investigate the effect of a smartphone app combined with gamification on the level of physical activity of adults and older adults.,"[{'ForeName': 'Maria do Socorro', 'Initials': 'MDS', 'LastName': 'Morais Pereira Simões', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Instituto de Saúde e Sociedade, 136 Silva Jardim st - room 338, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'de Barros Gonze', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Instituto de Saúde e Sociedade, 136 Silva Jardim st - room 338, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Neli', 'Initials': 'N', 'LastName': 'Leite Proença', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Instituto de Saúde e Sociedade, 136 Silva Jardim st - room 338, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Tonon Lauria', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Instituto de Saúde e Sociedade, 136 Silva Jardim st - room 338, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Vinícius', 'Initials': 'V', 'LastName': 'Demarchi Silva Terra', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Instituto de Saúde e Sociedade, 136 Silva Jardim st - room 338, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'da Costa Padovani', 'Affiliation': 'Departamento de Saúde, Educação e Sociedade, Universidade Federal de São Paulo, Instituto de Saúde e Sociedade, 136 Silva Jardim st - room 215, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Zuniga Dourado', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Instituto de Saúde e Sociedade, 136 Silva Jardim st - room 338, Santos, SP, 11015-020, Brazil. vzdourado@yahoo.com.br.'}]",Trials,['10.1186/s13063-019-3879-1']
599,31886828,Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial.,"Importance


Staphylococcus aureus is a leading cause of health care-associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates to S aureus colonization, a well-established predisposing factor to invasive S aureus disease.
Objective


To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
Design, Setting, and Participants


Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) with S aureus-colonized parent(s) were enrolled. The study period was November 7, 2014, through December 13, 2018.
Interventions


Parents were assigned to intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n = 117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n = 119) for 5 days.
Main Outcomes and Measures


The primary end point was concordant S aureus colonization by 90 days, defined as neonatal acquisition of an S aureus strain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of any S aureus strain and neonatal S aureus infections.
Results


Among 236 randomized neonates, 208 were included in the analytic sample (55% male; 76% singleton births; mean birth weight, 1985 g [SD, 958 g]; 76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up. Among 190 neonates included in the analysis, 74 (38.9%) acquired S aureus colonization by 90 days, of which 42 (56.8%) had a strain concordant with a parental baseline strain. In the intervention and placebo groups, 13 of 89 neonates (14.6%) and 29 of 101 neonates (28.7%), respectively, acquired concordant S aureus colonization (risk difference, -14.1% [95% CI, -30.8% to -3.9%]; hazard ratio [HR], 0.43 [95.2% CI, 0.16 to 0.79]). A total of 28 of 89 neonates (31.4%) in the intervention group and 46 of 101 (45.5%) in the control group acquired any S aureus strain (HR, 0.57 [95% CI, 0.31 to 0.88]), and 1 neonate (1.1%) in the intervention group and 1 neonate (1.0%) in the control group developed an S aureus infection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo).
Conclusions and Relevance


In this preliminary trial of parents colonized with S aureus, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an S aureus strain concordant with a parental baseline strain. However, further research is needed to replicate these findings and to assess their generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT02223520.",2020,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
","['76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up', '190 neonates included in the analysis, 74 (38.9', 'Neonates (n\u2009=\u2009236) with S aureus-colonized parent(s) were enrolled', ' 208 were included in the analytic sample (55% male', 'Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit', '76% singleton births; mean birth weight, 1985 g [SD, 958 g', 'The study period was November 7, 2014, through December 13, 2018', '236 randomized neonates', 'parents to neonates']","['placebo', 'intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n\u2009=\u2009117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n\u2009=\u2009119) for 5 days', 'intranasal mupirocin and topical chlorhexidine', 'intranasal mupirocin and chlorhexidine-impregnated cloths']","['neonatal acquisition of any S aureus strain and neonatal S aureus infections', 'acquired S aureus colonization', 'neonatal acquisition of an S aureus strain', 'neonatal colonization', 'Skin reactions', 'transmission of S aureus', 'concordant S aureus colonization']","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]",236.0,0.562881,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Voskertchian', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Koontz', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dina F', 'Initials': 'DF', 'LastName': 'Khamash', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Ross', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Aucott', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Carroll', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA,['10.1001/jama.2019.20785']
600,31790782,Post-trial low dose apomorphine prevents the development of morphine sensitization.,"The development of sensitization is one of the hallmarks of addictive drugs. Consistent with this relationship many studies have demonstrated that the highly addictive opioid agonist morphine induces sensitization effects. In this study, we administered morphine (10 mg/kg) (MOR) to induce sensitization. In that sensitization is considered to involve associative processes and that dopamine activity is an important contributor to learning and memory processes, we administered a dopamine inhibitory treatment using apomorphine (0.05 mg/kg) (APO) during memory consolidation following a morphine sensitization treatment protocol. Seemingly, a decrease in dopamine activity during consolidation would impair the salience of the association of the morphine response with the contextual cues during consolidation and interfere with the development of morphine sensitization. In two separate experiments, MOR or vehicle (VEH) were administered pre-trial and either VEH or APO were administered post-trial over 5 and 10 days of treatment, respectively. In both the 5 and 10 drug treatment sessions post-trial experiments, MOR groups given VEH immediately post-trial exhibited strong sensitization effects. These sensitization effects were substantially attenuated in the MOR groups given APO immediately post-trial but not in the MOR groups given APO after a 15 min. post-trial delay. In subsequent conditioning and sensitization challenge tests, the MOR groups that had been given APO immediately post-trial exhibited diminished sensitization and conditioned responses relative to MOR groups that had received VEH or APO delayed post-trial. This MOR-APO interaction effect was unique in that it occurred post-trial so that it was only expressed in a pre-trial test in which only MOR was administered. Seemingly, the inhibitory dopamine effect of APO was incorporated into memory during the post-trial consolidation process suggesting that drug/drug interactions can occur during consolidation.",2020,These sensitization effects were substantially attenuated in the MOR groups given APO immediately post-trial but not in the MOR groups given APO after a 15 min.,[],"['morphine', 'VEH or APO', 'apomorphine', 'dopamine inhibitory treatment apomorphine']","['MOR-APO interaction effect', 'dopamine activity', 'sensitization effects']",[],"[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}]",,0.0601612,These sensitization effects were substantially attenuated in the MOR groups given APO immediately post-trial but not in the MOR groups given APO after a 15 min.,"[{'ForeName': 'João Marcos', 'Initials': 'JM', 'LastName': 'de Mello Bastos', 'Affiliation': 'Behavioral Pharmacology Group, Laboratory of Animal Morphology and Pathology, State University of North Fluminense Darcy Ribeiro, Avenida Alberto Lamego, 2000, Campos dos Goytacazes, 28013-602 RJ, Brazil.'}, {'ForeName': 'Joaquim Barbosa', 'Initials': 'JB', 'LastName': 'Leite', 'Affiliation': 'Behavioral Pharmacology Group, Laboratory of Animal Morphology and Pathology, State University of North Fluminense Darcy Ribeiro, Avenida Alberto Lamego, 2000, Campos dos Goytacazes, 28013-602 RJ, Brazil.'}, {'ForeName': 'Richard Ian', 'Initials': 'RI', 'LastName': 'Samuels', 'Affiliation': 'Department of Entomology and Plant Pathology, State University of North Fluminense Darcy Ribeiro, Campos dos Goytacazes, RJ, Brazil.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Carey', 'Affiliation': 'Department of Psychiatry SUNY Upstate Medical University, 800 Irving Avenue, Syracuse, NY 13210, USA.'}, {'ForeName': 'Marinete Pinheiro', 'Initials': 'MP', 'LastName': 'Carrera', 'Affiliation': 'Behavioral Pharmacology Group, Laboratory of Animal Morphology and Pathology, State University of North Fluminense Darcy Ribeiro, Avenida Alberto Lamego, 2000, Campos dos Goytacazes, 28013-602 RJ, Brazil. Electronic address: marinete@uenf.br.'}]",Behavioural brain research,['10.1016/j.bbr.2019.112398']
601,31274267,Surgical Pleth Index and Analgesia Nociception Index for intraoperative analgesia in patients undergoing neurosurgical spinal procedures: a comparative randomized study.,"BACKGROUND


The Surgical Plethysmographic Index (SPI) and the Analgesia Nociception Index (ANI) have been suggested for the non-invasive intraoperative monitoring of nociception/anti-nociception balance. We aimed to compare patterns of intraoperative use of opioids, postoperative cortisol levels and postoperative pain scores after intraoperative analgesia guided either by ANI, SPI or anesthesiologist's judgment.
METHODS


Seventy-two adult ASA I-III patients scheduled for elective neurosurgical spinal procedures were randomized into the ANI group, SPI group and control group. Anesthesia and intraoperative use of opioids (sufentanil boluses based on body weight) were managed according to a strict protocol. The use of sufentanil was targeted to keep ANI value 50-70 in the ANI group, SPI value below individual postinduction baseline value plus 10 points in the SPI group. In the control group, the use of opioids was left at anesthesiologist's discretion.
RESULTS


Additional sufentanil boluses were administered earlier in the ANI and SPI groups in comparison to the control group (third dose after 51.8±22.1 vs. 52.7±14.8 vs. 84.5±24.8 min respectively, P=0.001; fourth dose after 61.3±30.1 vs. 57.2±14.1 vs. 120.0±26.2 min, P=0.003, and fifth dose after 78.8±33.7 vs. 74.0±11.6 vs. 146.7±23.2 min respectively, P=0.009). There were no differences in postoperative cortisol levels, time to spontaneous breathing at the end of anesthesia and postoperative pain scores.
CONCLUSIONS


Both ANI and SPI guidance significantly modified intraoperative opioid use, but no modification of postoperative cortisol levels and postoperative pain was observed.",2019,"RESULTS


Additional sufentanil boluses were administered earlier in the ANI and SPI groups in comparison to the control group (3rd dose after 51.8 ± 22.1 vs 52.7 ± 14.8 vs 84.5 ± 24.8 min respectively, p = 0.001; 4th dose after 61.3 ± 30.1 vs 57.2 ± 14.1 vs 120.0 ± 26.2 min, p = 0.003, and 5th dose after 78.8 ± 33.7 vs 74.0 ± 11.6 vs 146.7 ± 23.2 min respectively, p = 0.009).","['patients undergoing neurosurgical spinal procedures', 'Seventy two adult ASA I - III patients scheduled for elective neurosurgical spinal procedures']","['SPI group and control group', 'Surgical Pleth Index And Analgesia Nociception Index', 'sufentanil', 'opioids (sufentanil boluses', ""intraoperative analgesia guided either by ANI, SPI or anaesthesiologist's judgment""]","['postoperative cortisol levels and postoperative pain scores', 'postoperative cortisol levels, time to spontaneous breathing at the end of anaesthesia and postoperative pain scores', 'postoperative cortisol levels and postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0326040', 'cui_str': 'Ani'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",72.0,0.0563349,"RESULTS


Additional sufentanil boluses were administered earlier in the ANI and SPI groups in comparison to the control group (3rd dose after 51.8 ± 22.1 vs 52.7 ± 14.8 vs 84.5 ± 24.8 min respectively, p = 0.001; 4th dose after 61.3 ± 30.1 vs 57.2 ± 14.1 vs 120.0 ± 26.2 min, p = 0.003, and 5th dose after 78.8 ± 33.7 vs 74.0 ± 11.6 vs 146.7 ± 23.2 min respectively, p = 0.009).","[{'ForeName': 'Vlasta', 'Initials': 'V', 'LastName': 'Dostalova', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine Hradec Kralove, University Hospital Hradec Kralove, Charles University, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Schreiberova', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine Hradec Kralove, University Hospital Hradec Kralove, Charles University, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bartos', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Hradec Kralove University Hospital, Charles University, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Kukralova', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine Hradec Kralove, University Hospital Hradec Kralove, Charles University, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Dostal', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine Hradec Kralove, University Hospital Hradec Kralove, Charles University, Hradec Kralove, Czech Republic - pavel.dostal@fnhk.cz.'}]",Minerva anestesiologica,['10.23736/S0375-9393.19.13765-0']
602,31335267,Beyond Personal Responsibility: Examining the Effects of Narrative Engagement on Communicative and Civic Actions.,"Moving beyond personal responsibility-taking behaviors, this paper examines  communicative  (interpersonal talk and online message sharing) and  civic  (public policy support and intention to donate) behavioral outcomes in the context of narrative persuasion. A web-based experiment was conducted to test the mediating effects of two narrative engagement constructs, transportation and empathy, on these behavioral outcomes. Participants recruited via Amazon Mechanical Turk (n = 467) participated in an experiment conducted on Qualtrics, where they were randomized to read either a narrative or a nonnarrative message about factors contributing to obesity. The narrative message, compared to the nonnarrative message, generated greater transportation and affective empathy but had no overall advantage regarding behavioral outcomes. Path analyses showed consistent, significant indirect effects via transportation and affective empathy on all the outcome variables: online message sharing, interpersonal talk, public policy support, and intention to donate to a non-profit obesity organization. Our study contributes to the extant narrative research by shedding light on how narrative messages, via engaging the audience, could shape social responses beyond personal responsibility-taking. Implications and limitations of findings were discussed.",2019,"The narrative message, compared to the nonnarrative message, generated greater transportation and affective empathy but had no overall advantage regarding behavioral outcomes.",['Participants recruited via Amazon Mechanical Turk (n\xa0=\xa0467) participated in an experiment conducted on Qualtrics'],['Narrative Engagement'],"['message sharing, interpersonal talk, public policy support, and intention to donate to a non-profit obesity organization']","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0034033', 'cui_str': 'Public Policy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0220885', 'cui_str': 'organization'}]",467.0,0.0211891,"The narrative message, compared to the nonnarrative message, generated greater transportation and affective empathy but had no overall advantage regarding behavioral outcomes.","[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Communication, University of Utah, Languages and Communication Building , Salt Lake City , Utah , USA.'}, {'ForeName': 'Tae Kyoung', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Communication, University of Utah, Languages and Communication Building , Salt Lake City , Utah , USA.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Qian', 'Affiliation': 'Department of Communication, University of Utah, Languages and Communication Building , Salt Lake City , Utah , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1643954']
603,32125434,Meningococcal and pneumococcal carriage in Hajj pilgrims: findings of a randomized controlled trial.,"BACKGROUND


Intense congestion during the Hajj pilgrimage amplifies the risk of meningococcal carriage and disease, and there have been many meningococcal outbreaks reported amongst pilgrims. Thus, a strict vaccination policy is enforced by the host country and either polysaccharide or conjugate quadrivalent meningococcal vaccines are mandatory. However, unlike conjugate vaccines, the polysaccharide vaccine is not thought to reduce pharyngeal carriage of meningococci.
METHODS


A single-blinded, randomized, controlled trial amongst pilgrims from Saudi Arabia and Australia during the Hajj seasons of 2016-2017 was conducted to compare MenACWY-Conjugate vaccine with MenACWY-Polysaccharide vaccine, to determine if the conjugate vaccine is more effective in reducing asymptomatic carriage of meningococci, and whether the effect may be long-standing. Oropharyngeal swabs were obtained pre-, immediately post- and 6-11 months following completion of Hajj and tested for the presence of meningococci.
RESULTS


Amongst 2000 individuals approached, only 1146 participants aged 18-91 (mean 37.6) years agreed to participate and were randomized to receive either the polysaccharide (n = 561) or the conjugate (n = 561) vaccine, 60.8% were male, and 93.5% were from Saudi Arabia. Amongst oropharyngeal swabs obtained before Hajj, only two (0.2%) tested positive for Neisseria meningitidis. Similarly, meningococci were identified in only one sample at each of the post-Hajj and late follow-up visits. None of the carriage isolates were amongst the serogroups covered by the vaccines. A post hoc analysis of the third swabs revealed that 22.4% of all participants (50/223) were positive for Streptococcus pneumoniae nucleic acid.
CONCLUSION


The low overall carriage rate of meningococci found amongst Hajj pilgrims in 2016 and 2017 demonstrates a successful vaccination policy, but neither supports nor refutes the superiority of meningococcal conjugate ACWY vaccine over the polysaccharide vaccine against carriage. Although an association could not be established in this study, molecular epidemiology would help to establish the role of Hajj in facilitating transmission of pneumococci and inform vaccination policy.",2020,"Among oropharyngeal swabs obtained before Hajj, only two (0.2%) tested positive for Neisseria meningitidis.","['2000 individuals approached, only 1146 participants aged 18-91 (mean 37.6) years agreed to participate', 'pilgrims from Saudi Arabia and Australia during the Hajj seasons of 2016-2017', 'Hajj pilgrims']","['vaccine with MenACWY-Polysaccharide vaccine', 'polysaccharide (n\u2009=\u2009561) or conjugate (n\u2009=\u2009561) vaccine']",[],"[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]",[],,0.259203,"Among oropharyngeal swabs obtained before Hajj, only two (0.2%) tested positive for Neisseria meningitidis.","[{'ForeName': 'Al-Mamoon', 'Initials': 'AM', 'LastName': 'Badahdah', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah 22252, Saudi Arabia.'}, {'ForeName': 'Marwan A', 'Initials': 'MA', 'LastName': 'Bakarman', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah 22252, Saudi Arabia.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Khatami', 'Affiliation': ""The Discipline of Child and Adolescent Health, The Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Tashani', 'Affiliation': ""The Discipline of Child and Adolescent Health, The Children's Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Westmead, NSW 2145, Australia.""}, {'ForeName': 'Osamah', 'Initials': 'O', 'LastName': 'Barasheed', 'Affiliation': 'The Executive Administration of Research and Innovation, King Abdullah Medical City in Holy Capital (KAMC-HC), Makkah 24246, Saudi Arabia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Alfelali', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah 22252, Saudi Arabia.'}, {'ForeName': 'Mohammad I', 'Initials': 'MI', 'LastName': 'Azeem', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW 2145, Australia.""}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Bokhary', 'Affiliation': 'Umm Al-Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soltan', 'Affiliation': 'Microbiology department, Al Borg Medical Laboratories, Jeddah 21573, Saudi Arabia.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Lahra', 'Affiliation': 'The World Health Organisation Collaborating Centre for STI and AMR, and Neisseria Reference Laboratory, New South Wales Health Pathology, Microbiology, Prince of Wales Hospital, Randwick, NSW, 2031, Australia.'}, {'ForeName': 'Neisha', 'Initials': 'N', 'LastName': 'Jeoffreys', 'Affiliation': 'New South Wales Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital and University of Sydney, Westmead NSW 2145, Australia.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Kok', 'Affiliation': 'New South Wales Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital and University of Sydney, Westmead NSW 2145, Australia.'}, {'ForeName': 'Dominic E', 'Initials': 'DE', 'LastName': 'Dwyer', 'Affiliation': 'New South Wales Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital and University of Sydney, Westmead NSW 2145, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Booy', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW 2145, Australia.""}, {'ForeName': 'Harunor', 'Initials': 'H', 'LastName': 'Rashid', 'Affiliation': ""National Centre for Immunisation Research and Surveillance (NCIRS), The Children's Hospital at Westmead, NSW 2145, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of travel medicine,['10.1093/jtm/taaa032']
604,32098609,Dabigatran Treatment of Acute Noncardioembolic Ischemic Stroke.,"Background and Purpose- Patients with transient ischemic attack (TIA) and minor ischemic stroke are at risk for early recurrent cerebral ischemia. Anticoagulants are associated with reduced recurrence but also increased hemorrhagic transformation (HT). The safety of the novel oral anticoagulant dabigatran in acute stroke has not been evaluated. Methods- DATAS II (Dabigatran Treatment of Acute Stroke II) was a phase II prospective, randomized open label, blinded end point trial. Patients with noncardioembolic stroke/transient ischemic attack (National Institutes of Health Stroke Scale score, ≤9; infarct volume, ≤25 mL) were randomized to dabigatran or aspirin. Magnetic resonance imaging was performed before randomization and repeated at day 30. Imaging end points were ascertained centrally by readers blinded to treatment. The primary end point was symptomatic HT within 37 days of randomization. Results- A total of 305 patients, mean age 66.59±13.21 years, were randomized to dabigatran or aspirin a mean of 42.00±17.31 hours after symptom onset. The qualifying event was a transient ischemic attack in 21%, and ischemic stroke in 79% of patients. Median National Institutes of Health Stroke Scale (interquartile range) was 1 (0-2), and mean infarct volume 3.2±6.5 mL. No symptomatic HT occurred. Asymptomatic petechial HT developed in 11/142 (7.8%) of dabigatran-assigned patients and 5/142 (3.5%) of aspirin-assigned patients (relative risk, 2.301 [95% CI, 0.778-6.802]). Baseline infarct volume predicted incident HT (odds ratio, 1.07 [95% CI, 1.03-1.12];  P =0.0026). Incident covert infarcts on day 30 imaging occurred in 9/142 (6.3%) of dabigatran-assigned and 14/142 (9.8%) of aspirin-assigned patients (relative risk, 0.62 [95% CI, 0.26, 1.48]). Conclusions- Dabigatran was associated with a risk of HT similar to aspirin in acute minor noncardioembolic ischemic stroke/transient ischemic attack. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02295826.",2020,"Asymptomatic petechial HT developed in 11/142 (7.8%) of dabigatran-assigned patients and 5/142 (3.5%) of aspirin-assigned patients (relative risk, 2.301 [95% CI, 0.778-6.802]).","['Acute Noncardioembolic Ischemic Stroke', 'Patients with noncardioembolic stroke/transient ischemic attack (National Institutes of Health Stroke Scale score, ≤9; infarct volume, ≤25 mL', 'A total of 305 patients, mean age 66.59±13.21 years']","['dabigatran or aspirin', 'Dabigatran', 'aspirin', 'Conclusions- Dabigatran', 'Magnetic resonance imaging']","['ischemic stroke', 'symptomatic HT', 'Asymptomatic petechial HT', 'Median National Institutes of Health Stroke Scale', 'hemorrhagic transformation (HT']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}]",305.0,0.308993,"Asymptomatic petechial HT developed in 11/142 (7.8%) of dabigatran-assigned patients and 5/142 (3.5%) of aspirin-assigned patients (relative risk, 2.301 [95% CI, 0.778-6.802]).","[{'ForeName': 'Ken S', 'Initials': 'KS', 'LastName': 'Butcher', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sheridan', 'Affiliation': ''}, {'ForeName': 'Thalia S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neuroscience, Radiology, and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (S.B.C., M.D.H.).'}, {'ForeName': 'Muzzafar', 'Initials': 'M', 'LastName': 'Siddiqui', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Gioia', 'Affiliation': 'University of Montreal, QC, Canada (L.C.G).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neuroscience, Radiology, and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (S.B.C., M.D.H.).'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Klahr', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Leka', 'Initials': 'L', 'LastName': 'Sivakumar', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Oscar R', 'Initials': 'OR', 'LastName': 'Benavente', 'Affiliation': 'University of British Columbia, Vancouver, Canada (T.S.F., O.R.B.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}]",Stroke,['10.1161/STROKEAHA.119.027569']
605,31262585,Safety and immunogenicity of hepatitis E vaccine in elderly people older than 65 years.,"BACKGROUND


Hepatitis E virus (HEV) infection is a leading cause of acute hepatitis worldwide, and results in high morbidity and mortality rates among elderly people in China. The hepatitis E vaccine, Hecolin®, has been shown to be safe and highly efficacious among healthy adults aged 16-65 years old. However, there is no data about Hecolin® vaccination in elderly people older than 65 years (y).
METHODS


An open-labeled, controlled trial was conducted to evaluate the safety and immunogenicity of Hecolin® among the elderly aged >65 y. A total of 601 eligible participants were enrolled. Among them, 200 elderly people aged >65 y and 201 adults aged 18-65 y were assigned to the Hecolin® groups and vaccinated at day 0, month 1 and month 6. Serum samples were collected for anti-HEV IgG determination at day 0 prior to immunization and at month 7. The remaining 200 elderly people aged >65 y were assigned to the safety control group and received no intervention but were instructed to report any adverse events that occurred during the whole study period in the same way as those in the Hecolin® groups.
RESULTS


After receiving 3 doses of Hecolin® with the standard schedule, most (96.7%) of the vaccinated elderly people aged >65 y seroconverted at one month after the final dose (month 7). At month 7, the geometric mean concentrations of anti-HEV IgG were 5.36 (95% CI, 3.88-7.41) and 19.65 (95% CI, 16.81-22.98) among the baseline seronegative and seropositive elderly, respectively. Of the vaccinated elderly, 97.3% (177/182) had anti-HEV IgG levels higher than 1.0 WU/ml at month 7. Hecolin® was very well tolerated in this population. No vaccine-related SAEs were reported.
CONCLUSIONS


Hecolin® is immunogenic and well tolerated in elderly people aged greater than 65 years.",2019,"Of the vaccinated elderly, 97.3% (177/182) had anti-HEV IgG levels higher than 1.0 WU/ml at month 7.","['200 elderly people aged >65 y and 201 adults aged', 'elderly aged ', '18-65 y', '601 eligible participants were enrolled', 'elderly people aged greater than 65\u202fyears', 'healthy adults aged 16-65\u202fyears old', 'elderly people older than 65\u202fyears', 'elderly people in China', 'elderly people older than 65\u202fyears (y', '65', '200 elderly people aged >65 y']","['hepatitis E vaccine', 'Hecolin®']","['Safety and immunogenicity', 'anti-HEV IgG levels', 'safety and immunogenicity', 'geometric mean concentrations of anti-HEV IgG']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0085293', 'cui_str': 'Hepatitis, Water-Borne'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3529763', 'cui_str': 'hecolin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0312636', 'cui_str': 'Antibody to hepatitis E virus'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",601.0,0.0562446,"Of the vaccinated elderly, 97.3% (177/182) had anti-HEV IgG levels higher than 1.0 WU/ml at month 7.","[{'ForeName': 'Xu-Ya', 'Initials': 'XY', 'LastName': 'Yu', 'Affiliation': 'Xiamen Innovax Biotech Co.Ltd, Xiamen 361022, China.'}, {'ForeName': 'Zhi-Ping', 'Initials': 'ZP', 'LastName': 'Chen', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Shen-Yu', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Xiamen Innovax Biotech Co.Ltd, Xiamen 361022, China.'}, {'ForeName': 'Zhi-Fang', 'Initials': 'ZF', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Qiu-Fen', 'Initials': 'QF', 'LastName': 'Zhang', 'Affiliation': 'Xiamen Innovax Biotech Co.Ltd, Xiamen 361022, China.'}, {'ForeName': 'Ling-Zhi', 'Initials': 'LZ', 'LastName': 'Shen', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Zheng', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Chuan-Fu', 'Initials': 'CF', 'LastName': 'Yan', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Kaihua Center for Disease Control and Prevention, Quzhou 324300, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361005, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361005, China.'}, {'ForeName': 'Hua-Kun', 'Initials': 'HK', 'LastName': 'Lv', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, China. Electronic address: hklv@cdc.zj.cn.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361005, China. Electronic address: huangshoujie@xmu.edu.cn.'}]",Vaccine,['10.1016/j.vaccine.2019.04.006']
606,32125421,Stevia Beverage Consumption prior to Lunch Reduces Appetite and Total Energy Intake without Affecting Glycemia or Attentional Bias to Food Cues: A Double-Blind Randomized Controlled Trial in Healthy Adults.,"BACKGROUND


Stevia is a zero-calorie alternative to caloric sugars. Substituting caloric sweeteners with noncaloric sweeteners reduces available energy, but their effects on appetite, subsequent food intake, and neurocognitive responses are still unclear.
OBJECTIVE


The aim was to examine whether sweetness with or without calories influences food intake, appetite, blood glucose concentrations, and attentional bias (AB) to food cues.
METHODS


This was a randomized, controlled, double-blind crossover study. Healthy participants [n = 20; aged 27 ± 5 y,  55% female; BMI (kg/m2): 21.8 ± 1.5] completed 5 visits, consuming 5 study beverages: 330 mL water (control, no sweet taste, no calories) and either 330 mL water containing 40 g glucose or sucrose (sweet taste; calories, both 160 kcal), maltodextrin (no sweet taste; calories, 160 kcal), or 240 ppm stevia (sweet taste, no calories). Glucose and stevia beverages were matched for sweetness. Subjective appetite ratings and blood glucose were measured at baseline and at 15, 30, and 60 min postprandially. At 15 min participants performed a visual-dot probe task to assess AB to food cues; at 30 min, participants were offered an ad libitum lunch; food intake was measured.
RESULTS


Subjective appetite ratings showed that preload sweetness and calorie content both affected appetite. The total AUC for glycemia was significantly higher after the caloric beverages (mean ± SD: maltodextrin, 441 ± 57.6;  glucose, 462 ± 68.1;  sucrose, 425 ± 53.6 mmol × min × L-1 ) compared with both stevia (320 ± 34.2 mmol × min × L-1) and water (304 ± 32.0 mmol × min × L-1) (all P < 0.001). Total energy intake (beverage and meal) was significantly lower after the stevia beverage (727 ± 239 kcal) compared with water (832 ± 198 kcal,  P = 0.013), with no significant difference between the water and caloric beverages (P = 1.00 for water vs. maltodextrin, glucose, and sucrose). However, food-related AB did not differ across conditions (P = 0.140).
CONCLUSIONS


This study found a beneficial and specific effect of a stevia beverage consumed prior to a meal on appetite and energy intake in healthy adults. This trial is registered at clinicaltrials.gov as NCT03711084.",2020,"Total energy intake (beverage and meal) was significantly lower after the stevia beverage (727 ± 239 kcal) compared with water (832 ± 198 kcal,  P = 0.013), with no significant difference between the water and caloric beverages (P = 1.00 for water vs. maltodextrin, glucose, and sucrose).","['Healthy participants [n\xa0=\xa020; aged 27\xa0±\xa05', 'Healthy Adults', 'healthy adults', 'y, \xa055% female; BMI (kg/m2']","['maltodextrin, 441\xa0±\xa057.6; \xa0glucose, 462\xa0±\xa068.1; \xa0sucrose, 425\xa0±\xa053.6\xa0mmol × min × L-1 ', 'stevia beverage consumed prior to a meal', ' 21.8\xa0±\xa01.5]\xa0completed 5 visits, consuming 5 study beverages: 330 mL\xa0water (control, no sweet taste, no calories) and either 330 mL\xa0water containing 40\xa0g glucose or sucrose (sweet taste; calories, both 160\xa0kcal), maltodextrin (no sweet taste; calories, 160\xa0kcal), or 240\xa0ppm stevia (sweet taste, no calories']","['appetite, subsequent food intake, and neurocognitive responses', 'water and caloric beverages', 'Subjective appetite ratings and blood glucose', 'total AUC for glycemia', 'Appetite and Total Energy Intake without Affecting Glycemia or Attentional Bias to Food Cues', 'food intake, appetite, blood glucose concentrations, and attentional bias (AB) to food cues', 'Glucose and stevia beverages', 'Total energy intake (beverage and meal']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0673362', 'cui_str': 'L-1 (ester)'}, {'cui': 'C1018893', 'cui_str': 'Stevia'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1018893', 'cui_str': 'Stevia'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]",,0.232036,"Total energy intake (beverage and meal) was significantly lower after the stevia beverage (727 ± 239 kcal) compared with water (832 ± 198 kcal,  P = 0.013), with no significant difference between the water and caloric beverages (P = 1.00 for water vs. maltodextrin, glucose, and sucrose).","[{'ForeName': 'Nikoleta S', 'Initials': 'NS', 'LastName': 'Stamataki', 'Affiliation': 'Division of Diabetes, Endocrinology, and Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine, and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'Cargill R&D Center North America, Minneapolis, MN, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Neuroscience and Psychiatry Unit, Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'McKie', 'Affiliation': 'Faculty of Biology, Medicine and Health Platform Sciences, Enabling Technologies and Infrastructure, Faculty of Biology, Medicine and Health Research and Innovation, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Douwina', 'Initials': 'D', 'LastName': 'Bosscher', 'Affiliation': 'Cargill R&D Centre Europe, Vilvoorde, Belgium.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology, and Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine, and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa038']
607,32131964,Preoperative behavioural intervention to reduce drinking before elective orthopaedic surgery: the PRE-OP BIRDS feasibility RCT.,"BACKGROUND


Heavy alcohol consumption is associated with an increased risk of postoperative complications and extended hospital stay. Alcohol consumption therefore represents a modifiable risk factor for surgical outcomes. Brief behavioural interventions have been shown to be effective in reducing alcohol consumption among increased risk and risky drinkers in other health-care settings and may offer a method of addressing preoperative alcohol consumption.
OBJECTIVES


To investigate the feasibility of introducing a screening process to assess adult preoperative drinking levels and to deliver a brief behavioural intervention adapted for the target population group. To conduct a two-arm (brief behavioural intervention plus standard preoperative care vs. standard preoperative care alone), multicentre, pilot randomised controlled trial to assess the feasibility of proceeding to a definitive trial. To conduct focus groups and a national web-based survey to establish current treatment as usual for alcohol screening and intervention in preoperative assessment.
DESIGN


A single-centre, qualitative, feasibility study was followed by a multicentre, two-arm (brief behavioural intervention vs. treatment as usual), individually randomised controlled pilot trial with an embedded qualitative process evaluation. Focus groups and a quantitative survey were employed to characterise treatment as usual in preoperative assessment.
SETTING


The feasibility study took place at a secondary care hospital in the north-east of England. The pilot trial was conducted at three large secondary care centres in the north-east of England.
PARTICIPANTS


Nine health-care professionals and 15 patients (mean age 70.5 years, 86.7% male) participated in the feasibility study. Eleven health-care professionals and 68 patients (mean age 66.2 years, 80.9% male) participated in the pilot randomised trial. An additional 19 health-care professionals were recruited to one of three focus groups, while 62 completed an electronic survey to characterise treatment as usual.
INTERVENTIONS


The brief behavioural intervention comprised two sessions. The first session, delivered face to face in the preoperative assessment clinic, involved 5 minutes of structured brief advice followed by 15-20 minutes of behaviour change counselling, including goal-setting, problem-solving and identifying sources of social support. The second session, an optional booster, took place approximately 1 week before surgery and offered the opportunity to assess progress and boost self-efficacy.
MAIN OUTCOME MEASURES


Feasibility was assessed using rates of eligibility, recruitment and retention. The progression criteria for a definitive trial were recruitment of ≥ 40% of eligible patients and retention of ≥ 70% at 6-month follow-up. Acceptability was assessed using themes identified in qualitative data.
RESULTS


The initial recruitment of eligible patients was low but improved with the optimisation of recruitment processes. The recruitment of eligible participants to the pilot trial (34%) fell short of the progression criteria but was mitigated by very high retention (96%) at the 6-month follow-up. Multimethod analyses identified the methods as acceptable to the patients and professionals involved and offers recommendations of ways to further improve recruitment.
CONCLUSIONS


The evidence supports the feasibility of a definitive trial to assess the effectiveness of brief behavioural intervention in reducing preoperative alcohol consumption and for secondary outcomes of surgical complications if recommendations for further improvements are adopted.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN36257982.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 12. See the National Institute for Health Research Journals Library website for further project information.",2020,"Brief behavioural interventions have been shown to be effective in reducing alcohol consumption among increased risk and risky drinkers in other health-care settings and may offer a method of addressing preoperative alcohol consumption.
","['An additional 19 health-care professionals', 'three large secondary care centres in the north-east of England', 'The feasibility study took place at a secondary care hospital in the north-east of England', 'eligible participants to the pilot trial (34%) fell short of the progression criteria but was mitigated by very high retention (96%) at the 6-month follow-up', 'Nine health-care professionals and 15 patients (mean age 70.5 years, 86.7% male) participated in the feasibility study', 'Eleven health-care professionals and 68 patients (mean age 66.2 years, 80.9% male']","['Preoperative behavioural intervention', 'behavioural intervention plus standard preoperative care vs. standard preoperative care alone', 'behavioural intervention', 'structured brief advice followed by 15-20 minutes of behaviour change counselling, including goal-setting, problem-solving and identifying sources of social support']","['Acceptability', 'preoperative alcohol consumption', 'rates of eligibility, recruitment and retention']","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0015730', 'cui_str': 'Feasibility Studies'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0337953', 'cui_str': 'Secondary care hospital (environment)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033061', 'cui_str': 'Preoperative Care'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0037438'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.0717742,"Brief behavioural interventions have been shown to be effective in reducing alcohol consumption among increased risk and risky drinkers in other health-care settings and may offer a method of addressing preoperative alcohol consumption.
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Snowden', 'Affiliation': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Lynch', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Avery', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Haighton', 'Affiliation': 'Department of Social Work, Education & Community Wellbeing, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Mamasoula', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Eilish', 'Initials': 'E', 'LastName': 'Gilvarry', 'Affiliation': 'Newcastle Addictions Service, Northumberland Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prentis', 'Affiliation': 'The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Gerrand', 'Affiliation': 'Royal National Orthopaedic Hospital, Stanmore, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Steel', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Goudie', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Howe', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24120']
608,32138631,Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage.,"Background and Purpose- EG-1962 is a sustained release formulation of nimodipine administered via external ventricular drain in patients with aneurysmal subarachnoid hemorrhage. A randomized, open-label, phase 1/2a, dose-escalation study provided impetus for this study to evaluate efficacy and safety of a single intraventricular 600 mg dose of EG-1962 to patients with aneurysmal subarachnoid hemorrhage, compared with standard of care oral nimodipine. Methods- Subjects were World Federation of Neurological Surgeons grades 2-4, modified Fisher grades 2-4 and had an external ventricular drain inserted as part of standard of care. The primary end point was the proportion of subjects with favorable outcome at day 90 after aneurysmal subarachnoid hemorrhage (extended Glasgow outcome scale 6-8). The proportion of subjects with favorable outcome at day 90 on the Montreal cognitive assessment, as well as the incidence of delayed cerebral ischemia and infarction, use of rescue therapy and safety were evaluated. Results- The study was halted by the independent data monitoring board after planned interim analysis of 210 subjects (289 randomized) with day 90 outcome found the study was unlikely to achieve its primary end point. After day 90 follow-up of all subjects, the proportion with favorable outcome on the extended Glasgow outcome scale was 45% (65/144) in the EG-1962 and 42% (62/145) in the placebo group (risk ratio, 1.01 [95% CI, 0.83-1.22],  P =0.95). Consistent with its mechanism of action, EG-1962 significantly reduced vasospasm (50% [69/138] EG-1962 versus 63% [91/144],  P =0.025) and hypotension (7% [9/138] versus 10% [14/144]). Analysis of prespecified subject strata suggested potential efficacy in World Federation of Neurological Surgeons 3-4 subjects (46% [32/69] EG-1962 versus 32% [24/75] placebo, odds ratio, 1.22 [95% CI, 0.94-1.58],  P =0.13). No safety concerns were identified that halted the study or that preclude further development. Conclusions- There was no significant increase in favorable outcome for EG-1962 compared with standard of care in the overall study population. The safety profile was acceptable. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02790632.",2020,There was no significant increase in favorable outcome for EG-1962 compared with standard of care in the overall study population.,"['210 subjects (289 randomized', 'patients with aneurysmal subarachnoid hemorrhage, compared with standard of care oral', 'Aneurysmal Subarachnoid Hemorrhage', 'patients with aneurysmal subarachnoid hemorrhage']","['nimodipine', 'placebo', ' and Purpose', 'EG-1962', 'Nimodipine Microparticles Versus Oral Nimodipine', 'Conclusions']","['efficacy and safety', 'favorable outcome for EG-1962', 'extended Glasgow outcome scale', 'vasospasm', 'delayed cerebral ischemia and infarction, use of rescue therapy and safety', 'proportion of subjects with favorable outcome at day 90 after aneurysmal subarachnoid hemorrhage', 'hypotension']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0085616', 'cui_str': 'Vasospasm (finding)'}, {'cui': 'C0917798', 'cui_str': 'Cerebral Ischemia'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.0583632,There was no significant increase in favorable outcome for EG-1962 compared with standard of care in the overall study population.,"[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Carlson', 'Affiliation': 'From the Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque (A.P.C.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hänggi', 'Affiliation': 'Department of Neurosurgery, Düsseldorf University Hospital, Heinrich-Heine-Universität, Germany (D.H.).'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery and Neurosurgery, Prince of Wales Hospital, The Chinese University of Hong Kong, China (G.K.W.).'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Etminan', 'Affiliation': 'Department of Neurosurgery, Ruprecht-Karls-University Heidelberg, Mannheim, Germany (N.E.).'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Mayer', 'Affiliation': 'Department of Neurology, Henry Ford Health System, Detroit, MI (S.A.M.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Aldrich', 'Affiliation': 'Department of Neurosurgery, University of Maryland (F.A.).'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Diringer', 'Affiliation': 'Neurological Critical Care, Washington University School of Medicine, St Louis, MO (M.N.D.).'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Schmutzhard', 'Affiliation': 'Department of Neurology, Neurointensive Care Unit, Medical University Innsbruck, Austria (E.S.).'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Faleck', 'Affiliation': 'Edge Therapeutics, Berkeley Heights, NJ (H.J.F., R.L.M.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ng', 'Affiliation': 'WuXi Clinical, Austin, TX (D.N.).'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants LLC, Austin, TX (B.R.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bleck', 'Affiliation': 'Department of Neurology, Northwestern University, Feinberg School of Medicine, Chicago, IL (T.B.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grubb', 'Affiliation': 'Department of Neurological Surgery, Washington University Medical Center, St Louis, MO (R.G.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Integrated Medical Development, Princeton Junction, NJ (M.M.).'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD (J.I.S.).'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin & Associates, Rochester, New York, NY (H.M.P.).'}, {'ForeName': 'R Loch', 'Initials': 'RL', 'LastName': 'Macdonald', 'Affiliation': 'Edge Therapeutics, Berkeley Heights, NJ (H.J.F., R.L.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027396']
609,31325313,An investigation of the effects of procalcitonin testing on antimicrobial prescribing in respiratory tract infections in an Irish university hospital setting: a feasibility study.,"BACKGROUND


Diagnostic uncertainty and a high prevalence of viral infections present unique challenges for antimicrobial prescribing for respiratory tract infections (RTIs). Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable.
METHODS


We conducted a feasibility study of the introduction of PCT testing in patients admitted to hospital with a lower RTI to determine if PCT testing is an effective and worthwhile intervention to introduce to support the existing antimicrobial stewardship (AMS) programme and safely decrease antimicrobial prescribing in patients admitted with RTIs.
RESULTS


A total of 79 patients were randomized to the intervention PCT-guided treatment group and 40 patients to the standard care respiratory control group. The addition of PCT testing led to a significant decrease in duration of antimicrobial prescriptions (mean 6.8 versus 8.9 days, P = 0.012) and decreased length of hospital stay (median 7 versus 8 days, P = 0.009) between the PCT and respiratory control group. PCT did not demonstrate a significant reduction in antimicrobial consumption when measured as DDDs and days of therapy.
CONCLUSIONS


PCT testing had a positive effect on antimicrobial prescribing during this feasibility study. The successful implementation of PCT testing in a randomized controlled trial requires an ongoing comprehensive education programme, greater integration into the AMS programme and delivery of PCT results in a timely manner. This feasibility study has shown that a larger randomized controlled trial would be beneficial to further explore the positive aspects of these findings.",2019,"Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable.
","['79 patients', 'respiratory tract infections in an Irish university hospital setting', 'patients with RTIs', 'patients admitted with RTIs', 'patients admitted to hospital with a lower RTI']","['procalcitonin testing', 'intervention PCT-guided treatment group and 40 patients to the standard care respiratory control group', 'Procalcitonin (PCT', 'antimicrobial stewardship (AMS) programme', 'PCT']","['length of hospital stay', 'antimicrobial consumption', 'duration of antimicrobial prescriptions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",79.0,0.0643984,"Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': ""O'Riordan"", 'Affiliation': 'Pharmacy Department, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'HRB Clinical Research Facility Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Clinical Pharmacy Research Group, School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Microbiology, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Palmer', 'Affiliation': 'HRB Clinical Research Facility Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dahly', 'Affiliation': 'HRB Clinical Research Facility Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Respiratory Medicine, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'Department of Respiratory Medicine, Mercy University Hospital, Grenville Place, Cork, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fleming', 'Affiliation': 'Pharmacy Department, Mercy University Hospital, Grenville Place, Cork, Ireland.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz313']
610,32145129,Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis.,"BACKGROUND & AIMS


Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of direct bilirubin in the phase 3, randomized, placebo-controlled Primary Biliary Cholangitis Obeticholic Acid International Study of Efficacy.
METHODS


This analysis assessed patients on the basis of their baseline direct bilirubin level (divided by quartile). Biochemistry and safety outcomes were evaluated within each quartile over time.
RESULTS


In the quartile with the highest baseline direct bilirubin (>5.47 µmol/L), there was a significant reduction in both direct and total bilirubin at Month 12 compared with placebo. Least squares mean (standard error) change from baseline in direct bilirubin at Month 12 was 4.17 (1.42) µmol/L for placebo, -3.48 (1.63) µmol/L for obeticholic acid 5-10 mg and -3.66 (1.51) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, -4.53 (1.83) µmol/L for obeticholic acid 5-10 mg and -5.06 (1.64) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo).
CONCLUSIONS


Obeticholic acid treatment was associated with significant reductions in total and direct bilirubin, particularly in patients with high baseline direct bilirubin. Because raised direct bilirubin levels, even within the normal range, are predictive of survival in primary biliary cholangitis, these results suggest substantial benefits of obeticholic acid in at-risk patients.",2020,"< .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, -4.53 (1.83) µmol/L for obeticholic acid","['patients with primary biliary cholangitis', 'patients with high baseline direct bilirubin']","['obeticholic acid', 'bilirubin with obeticholic acid treatment', 'Obeticholic acid', 'placebo', 'obeticholic acid vs placebo']","['total and direct bilirubin', 'Biochemistry and safety outcomes', 'highest baseline direct bilirubin', 'direct and total bilirubin', 'total bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin (substance)'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin (substance)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}]",,0.402476,"< .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, -4.53 (1.83) µmol/L for obeticholic acid","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Parés', 'Affiliation': 'Hospital Clinic, University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Bon Secours Mercy Health, Newport News, VA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Vargas', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, CIBERehd, Barcelona, Spain.""}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Invernizzi', 'Affiliation': 'Division of Gastroenterology and Center for Autoimmune Liver Diseases, San Gerardo Hospital, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Malecha', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Liberman', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, Toronto General Hospital and Department of Medicine, University of Toronto, Toronto, Canada.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14429']
611,32145206,Evaluation of Efficacy of Low Intensity Pulsed Ultrasound in Facilitating Mandibular Fracture Healing-A Blinded Randomized Controlled Clinical Trial.,"PURPOSE


The aim of the study was to evaluate the role of low intensity pulsed ultrasound (LIPUS) in improving fracture healing in American Society of Anesthesiologists Class II patients with mandibular fractures.
MATERIALS AND METHODS


A randomized controlled clinical trial of 40 patients with mandibular fractures was conducted. The patients were randomly allocated to the study and control groups, with 20 members each. A standardized surgical protocol was followed to manage the fractures by open reduction and internal fixation. After fixation, the study group received LIPUS stimulation (1.5 MHz, 30 mW/cm 2 ) on postoperative days 4, 8, 14, and 20 for 20 minutes daily; the control group received no LIPUS stimulation. The outcome parameters assessed were postoperative pain, wound healing, teeth mobility, and radiographic and ultrasound fracture healing.
RESULTS


The study variables were analyzed using the independent samples t test or Mann-Whitney U test. The pain score was reduced in the study group on all postoperative days (P < .001). The mean amount of wound healing was better in the study group than in the control group on days 5 and 9 (P < .004 and P < .019, respectively). The mean score for the ultrasound assessment of fracture healing was greater in the study group, with a statistically significant difference.
CONCLUSIONS


LIPUS application reduced postoperative pain and facilitated fracture healing in patients with compromised healing potential.",2020,The pain score was reduced in the study group on all postoperative days (P < .001).,"['American Society of Anesthesiologists Class II patients with mandibular fractures', '40 patients with mandibular fractures', 'patients with compromised healing potential']","['low intensity pulsed ultrasound (LIPUS', 'LIPUS stimulation', 'LIPUS application', 'Low Intensity Pulsed Ultrasound', 'control group received no LIPUS stimulation']","['postoperative pain and facilitated fracture healing', 'mean amount of wound healing', 'pain score', 'postoperative pain, wound healing, teeth mobility, and radiographic and ultrasound fracture healing', 'mean score for the ultrasound assessment of fracture healing']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C4042796', 'cui_str': 'Low Intensity Pulsed Ultrasound'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0040445', 'cui_str': 'Tooth Mobility'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",40.0,0.0370075,The pain score was reduced in the study group on all postoperative days (P < .001).,"[{'ForeName': 'Aswath', 'Initials': 'A', 'LastName': 'Gopalan', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Elavenil', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India. Electronic address: elavenilomfs@gmail.com.'}, {'ForeName': 'Guruprasad Thulasi', 'Initials': 'GT', 'LastName': 'Doss', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Keerthana', 'Initials': 'K', 'LastName': 'Ponvel', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Krishnakumar', 'Initials': 'K', 'LastName': 'Raja Vb', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.036']
612,32409838,Study on the prevention of infection in terminal cancer patients applying epidural analgesia by adding cefazolin to anesthetics: a randomized controlled trial.,"OBJECTIVE


To observe the antibacterial effect of adding cefazolin into anesthetics in patients with terminal cancer undergoing long-term epidural analgesia.
METHODS


Patients undergoing epidural analgesia with terminal cancer were randomly divided into two groups: the conventional drug group (group C) and the cefazolin group (group G). Both groups were given levobupivacaine and morphine, while cefazolin was added to group G. The mean arterial pressure (MAP), heart rate (HR), respiratory rates (R), visual analogue scale (VAS) scores, satisfaction and complications of patients in the two groups were observed. 3 ml of the used analgesic was taken for bacterial culture when replacing the new analgesic case.
RESULTS


HR, MAP, R, VAS scores, dosages of morphine, satisfaction of the analgesic and the complications were not significantly different between the two groups (P > 0.05). The overall satisfaction of patients in group G was significantly higher than that in group C (P < 0.05). One patient's anesthetics in group C were infected with colibacillus. Four patients in group C got infected in their epidural puncture sites. There was no infection in group G (P < 0.05).
CONCLUSION


Adding cefazolin to local anesthetics could effectively prevent bacterial infection and ensured the safety of epidural analgesia for patients with terminal cancer.",2020,"VAS scores, dosages of morphine, satisfaction of the analgesic and the complications were not significantly different between the two groups (P > 0.05).","['terminal cancer patients applying', 'Patients undergoing epidural analgesia with terminal cancer', 'patients with terminal cancer undergoing long-term epidural analgesia', 'patients with terminal cancer']","['cefazolin to anesthetics', 'cefazolin into anesthetics', 'epidural analgesia', 'cefazolin', 'levobupivacaine and morphine, while cefazolin']","['mean arterial pressure (MAP), heart rate (HR), respiratory rates (R), visual analogue scale (VAS) scores, satisfaction and complications', 'overall satisfaction', 'VAS scores, dosages of morphine, satisfaction of the analgesic and the complications']","[{'cui': 'C0741884', 'cui_str': 'End stage cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",4.0,0.0318469,"VAS scores, dosages of morphine, satisfaction of the analgesic and the complications were not significantly different between the two groups (P > 0.05).","[{'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}, {'ForeName': 'Zhanfang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa060']
613,31228031,Post-Hoc Analyses of the Effects of Baseline Sleep Quality on SHP465 Mixed Amphetamine Salts Extended-Release Treatment Response in Adults with Attention-Deficit/Hyperactivity Disorder.,"OBJECTIVE


Sleep problems are common in adults with attention-deficit/hyperactivity disorder (ADHD). The presence of sleep problems at the time of presentation for ADHD treatment could impact the level of improvement in ADHD symptoms or executive function occurring with ADHD pharmacotherapy. Therefore, we examined the influence of baseline sleep quality on the effects of SHP465 mixed amphetamine salts (MAS) extended-release.
METHODS


Adults (18-55 years) with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision-defined ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥ 24 were randomized to once-daily SHP465 MAS (12.5-75 mg) or placebo in a 7-week, double-blind, dose-optimization study. Post-hoc analyses evaluated SHP465 MAS treatment effects on ADHD symptoms, using the ADHD-RS-IV, and executive function, using the Brown Attention-Deficit Disorder Scale (BADDS), based on baseline sleep quality as defined by Pittsburgh Sleep Quality Index (PSQI) scores [sleep quality impaired (PSQI total score > 5; PSQI component scores 2 or 3) versus not impaired (PSQI total score ≤ 5; PSQI component scores 0 or 1)]. Analyses were conducted in the intent-to-treat population.
RESULTS


Of 280 enrolled participants, 272 were randomized (placebo, n = 135; SHP465 MAS, n = 137). The intent-to-treat population consisted of 268 participants (placebo, n = 132; SHP465 MAS, n = 136), and 170 participants (placebo, n = 76; SHP465 MAS, n = 94) completed the study. Treatment differences nominally favored SHP465 MAS over placebo in both sleep impairment groups regarding ADHD-RS-IV total score changes (all nominal p < 0.05), except for those with impairment defined by sleep efficiency (p = 0.2696), and regarding BADDS total score changes (all nominal p < 0.05), except for those with impairment defined by sleep duration (p = 0.1332) and sleep efficiency (p = 0.8226). There were no statistically significant differences in SHP465 MAS treatment effects between sleep impairment groups.
CONCLUSIONS


Improvements in ADHD symptoms and executive function occurred with dose-optimized SHP465 MAS, regardless of baseline impairment in some aspects of sleep in adults with ADHD, with no significant differences observed as a function of sleep impairment.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov identifier-NCT00150579.",2019,"Treatment differences nominally favored SHP465 MAS over placebo in both sleep impairment groups regarding ADHD-RS-IV total score changes (all nominal p < 0.05), except for those with impairment defined by sleep efficiency (p = 0.2696), and regarding BADDS total score changes (all nominal p < 0.05), except for those with impairment defined by sleep duration (p = 0.1332) and sleep efficiency (p = 0.8226).","['Adults (18-55\xa0years) with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition', '268 participants (placebo, n\u2009=\u2009132; SHP465 MAS, n\u2009=\u2009136), and 170 participants ', 'adults with ADHD', 'adults with attention-deficit/hyperactivity disorder (ADHD', 'Adults with Attention-Deficit/Hyperactivity Disorder', '280 enrolled participants']","['SHP465 MAS', 'placebo', 'SHP465 Mixed Amphetamine Salts', 'placebo, n\u2009=\u200976; SHP465 MAS', 'daily SHP465 MAS', 'SHP465 mixed amphetamine salts (MAS']","['SHP465 MAS', 'function of sleep impairment', 'ADHD symptoms or executive function', 'ADHD symptoms and executive function', 'ADHD symptoms, using the ADHD-RS-IV, and executive function, using the Brown Attention-Deficit Disorder Scale (BADDS), based on baseline sleep quality', 'Pittsburgh Sleep Quality Index (PSQI) scores [sleep quality impaired (PSQI total score >\u20095; PSQI component scores 2 or 3) versus not impaired (PSQI total score', 'sleep efficiency', 'Text Revision-defined ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥', 'sleep duration', 'ADHD-RS-IV total score changes', 'BADDS total score changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition (qualifier value)'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0222045'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4545801', 'cui_str': 'PSQI (Pittsburgh Sleep Quality Index) score'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",280.0,0.166612,"Treatment differences nominally favored SHP465 MAS over placebo in both sleep impairment groups regarding ADHD-RS-IV total score changes (all nominal p < 0.05), except for those with impairment defined by sleep efficiency (p = 0.2696), and regarding BADDS total score changes (all nominal p < 0.05), except for those with impairment defined by sleep duration (p = 0.1332) and sleep efficiency (p = 0.8226).","[{'ForeName': 'Craig B H', 'Initials': 'CBH', 'LastName': 'Surman', 'Affiliation': 'Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA, 02114, USA. csurman@partners.org.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Shire, a member of the Takeda group of companies, Lexington, MA, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shire, a member of the Takeda group of companies, Lexington, MA, USA.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Cortese', 'Affiliation': 'University of Southampton and Solent NHS Trust, Southampton, UK.'}]",CNS drugs,['10.1007/s40263-019-00645-z']
614,32409830,A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study).,"A randomized phase III trial was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy compared to the standard treatment, i.e. surgery plus adjuvant chemotherapy, for locally recurrent rectal cancer in local relapse-free survival. In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery. This trial has been registered at the Japan Registry of Clinical Trial: jRCTs031190076 [https://jrct.niph.go.jp/latest-detail/jRCTs031190076] and ClinicalTrials.gov: NCT04288999 [https://clinicaltrials.gov/ct2/show/NCT04288999].",2020,"The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery.","['locally recurrent rectal cancer', '110 patients from 43 Japanese institutions will be recruited over a period of 6\xa0years', 'Eligible patients']","['preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy', 'surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy']","['local relapse-free survival', 'overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery']","[{'cui': 'C0278554', 'cui_str': 'Rectal cancer recurrent'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",110.0,0.319184,"The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery.","[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kadota', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Tsukada', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakamura', 'Affiliation': 'Department of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Onaya', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa058']
615,31343548,"Effects of Citrulline Malate and Beetroot Juice Supplementation on Blood Flow, Energy Metabolism, and Performance During Maximum Effort Leg Extension Exercise.","Trexler, ET, Keith, DS, Schwartz, TA, Ryan, ED, Stoner, L, Persky, AM, and Smith-Ryan, AE. Effects of citrulline malate and beetroot juice supplementation on blood flow, energy metabolism, and performance during maximum effort leg extension exercise. J Strength Cond Res 33(9): 2321-2329, 2019-Citrulline malate (CitMal) and beetroot juice (BEET) are increasingly popular ergogenic aids, but few studies have rigorously investigated their effects on resistance exercise performance and underlying mechanisms. The current randomized, double-blind, crossover study evaluated the effects of CitMal and BEET supplementation on blood flow, metabolic efficiency, and performance during maximal isokinetic leg extension exercise. After familiarization, 27 recreationally active men (age: 22 ± 4 years) completed 3 visits in which subjects ingested a treatment beverage (CitMal [8 g], BEET [400-mg nitrate], or placebo [PLA]), followed by a 2-hour rest period, warm-up, and 5 sets of 30 concentric leg extensions. Before and after exercise, ultrasound was used to measure diameter (aDIAM) and blood flow (aBF) of the superficial femoral artery, along with cross-sectional area and echo intensity of the vastus lateralis. Plasma analytes (lactate, nitrate/nitrite [NOx], and urea nitrogen [BUN]) were also assessed at these times, and indirect calorimetry was used to measure energy expenditure and respiratory exchange ratio before and during exercise. Resting NOx values were higher in BEET (233.2 ± 1.1 μmol·L) compared with CitMal (15.3 ± 1.1, p < 0.0001) and PLA (13.4 ± 1.1, p < 0.0001). Postexercise NOx values, adjusted for resting differences, were higher in BEET (86.3 ± 1.2 μmol·L) than CitMal (21.3 ± 1.1, p < 0.0001) and PLA (18.1 ± 1.1, p < 0.0001). No other variables were affected by treatment (all p > 0.05). While BEET increased NOx, neither treatment was found to enhance performance, blood flow, metabolic efficiency, nor the hormonal response to leg extension exercise.",2019,"While BEET increased NOx, neither treatment was found to enhance performance, blood flow, metabolic efficiency, nor the hormonal response to leg extension exercise.",['27 recreationally active men (age: 22 ± 4 years) completed'],"['citrulline malate and beetroot juice supplementation', '2019-Citrulline malate (CitMal) and beetroot juice (BEET', 'CitMal and BEET supplementation', 'Citrulline Malate and Beetroot Juice Supplementation', '3 visits in which subjects ingested a treatment beverage (CitMal [8 g], BEET [400-mg nitrate], or placebo [PLA']","['Resting NOx values', 'Blood Flow, Energy Metabolism, and Performance', 'Trexler, ET, Keith, DS, Schwartz, TA, Ryan, ED, Stoner, L, Persky, AM, and Smith-Ryan, AE', 'energy expenditure and respiratory exchange ratio', 'blood flow, energy metabolism, and performance', 'enhance performance, blood flow, metabolic efficiency, nor the hormonal response to leg extension exercise', 'Plasma analytes (lactate, nitrate/nitrite [NOx], and urea nitrogen [BUN', 'measure diameter (aDIAM) and blood flow (aBF', 'blood flow, metabolic efficiency, and performance during maximal isokinetic leg extension exercise', 'Postexercise NOx values']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0109943', 'cui_str': 'citrulline malate'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0600054', 'cui_str': 'Beets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0443354', 'cui_str': 'Analyte (substance)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C1291218', 'cui_str': 'Urea nitrogen (substance)'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",,0.0748444,"While BEET increased NOx, neither treatment was found to enhance performance, blood flow, metabolic efficiency, nor the hormonal response to leg extension exercise.","[{'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Trexler', 'Affiliation': 'Department of Allied Health Sciences, Human Movement Science Curriculum, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Keith', 'Affiliation': 'Department of Exercise and Sport Science, Applied Physiology Laboratory, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Ryan', 'Affiliation': 'Department of Allied Health Sciences, Human Movement Science Curriculum, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Allied Health Sciences, Human Movement Science Curriculum, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Persky', 'Affiliation': 'Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Abbie E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Department of Allied Health Sciences, Human Movement Science Curriculum, University of North Carolina, Chapel Hill, North Carolina.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003286']
616,30966821,Impact of a cardiovascular disease risk screening result on preventive behaviour in asymptomatic participants of the ROBINSCA trial.,"INTRODUCTION


A teachable moment for preventive behavioural change can occur when asymptomatic individuals receive their cardiovascular disease screening result. This study investigated prevention-seeking behaviour and compliance with preventive treatment of participants of the population-based Risk Or Benefit IN Screening for CArdiovascular disease (ROBINSCA) trial after receiving a screening result.
METHODS


Asymptomatic Dutch individuals ( n  = 43,447) were randomly assigned (1:1:1) to screening for cardiovascular disease by either traditional risk assessment (intervention arm A), or determining the amount of coronary artery calcification (intervention arm B), or to usual care (control arm). A random sample ( n  = 600) of ROBINSCA participants with a screening result (arms A and B) received an online questionnaire (in 2017) to measure the impact of a cardiovascular disease screening result in low and increased (arm A: risk > 10%; arm B: Agatston ≥ 100) risk groups.
RESULTS


Of all respondents (438/600; 73%) 63.5% were men and the mean age ( ± standard deviation) was 63.8 ± 6.9 years. Individuals with an increased coronary artery calcification score consulted their general practitioner more often compared to increased risk individuals from arm A: 140/149 (94%) and 86/137 (62.8%), respectively ( P  < 0.001). Current use of blood pressure and cholesterol-lowering drugs was significantly higher in the increased coronary artery calcification score group (108/140; 77.1%), compared to the group with an increased traditional risk (35/80, 43.8%;  P  < 0.001). Self-reported compliance was high (98.1-100%).
CONCLUSION


Receiving the screening result might be a teachable moment that can enhance cardiovascular disease prevention-seeking behaviour through consulting a general practitioner and high compliance with preventive treatment. The impact of the screening result was more profound in the increased coronary artery calcification score group. Trial registration number: NTR6471.",2019,"Individuals with an increased coronary artery calcification score consulted their general practitioner more often compared to increased risk individuals from arm A: 140/149 (94%) and 86/137 (62.8%), respectively ( P < 0.001).","['participants of the population-based Risk Or Benefit IN Screening for CArdiovascular disease (ROBINSCA) trial after receiving a screening result', 'Of all respondents (438/600; 73%) 63.5% were men and the mean age (\u2009±\u2009standard deviation) was 63.8\u2009±\u20096.9 years', 'Asymptomatic Dutch individuals ( n\u2009=\u200943,447', 'asymptomatic participants of the ROBINSCA trial']","['online questionnaire', 'cardiovascular disease screening result in low and increased (arm A: risk\u2009>\u200910%; arm B: Agatston\u2009≥\u2009100) risk groups', 'screening for cardiovascular disease by either traditional risk assessment (intervention arm A), or determining the amount of coronary artery calcification (intervention arm B), or to usual care (control arm', 'cardiovascular disease risk screening']","['traditional risk', 'blood pressure and cholesterol-lowering drugs', 'coronary artery calcification score']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment (procedure)'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",43447.0,0.0707352,"Individuals with an increased coronary artery calcification score consulted their general practitioner more often compared to increased risk individuals from arm A: 140/149 (94%) and 86/137 (62.8%), respectively ( P < 0.001).","[{'ForeName': 'Sabine Jam', 'Initials': 'SJ', 'LastName': 'Denissen', 'Affiliation': '1 Department of Public Health, Erasmus Medical Centre, The Netherlands.'}, {'ForeName': 'Carlijn M', 'Initials': 'CM', 'LastName': 'van der Aalst', 'Affiliation': '1 Department of Public Health, Erasmus Medical Centre, The Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Vonder', 'Affiliation': '2 Centre for Medical Imaging North-East Netherlands (CMI-NEN), University of Groningen, University Medical Centre Groningen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': '2 Centre for Medical Imaging North-East Netherlands (CMI-NEN), University of Groningen, University Medical Centre Groningen, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': '1 Department of Public Health, Erasmus Medical Centre, The Netherlands.'}]",European journal of preventive cardiology,['10.1177/2047487319843396']
617,31213144,To Treat or Not to Treat: The Effect of Hypothetical Patients' Suicidal Severity on Therapists' Willingness to Treat.,"Therapists' intense negative emotional responses regarding suicidal patients raise questions about therapists' willingness to treat them; however, this issue has yet to be investigated. The aim of the current study is to examine to what extent the severity of suicidality of a hypothetical patient will influence therapists' willingness to treat and the likelihood of their referring out. Mental health professionals (N = 249) completed a questionnaire that presented a vignette of a hypothetical patient referred for psychological treatment. The vignette contained a manipulation of the severity of suicidality levels of the referred patient, with two randomly assigned conditions: suicidal or depressive symptoms. Participants were then asked about their willingness to treat the hypothetical patient. Our results showed that willingness to treat was significantly lower and the likelihood of referring out was significantly higher among therapists in the suicidal patient condition, relative to the depressive patient condition. Longer professional seniority and previous training in suicide prevention moderated these effects. Our findings highlighted therapists' reluctance, especially among young practitioners, to treat suicidal patients, an inclination that may have a critical impact on patient suicidal outcomes. Findings reinforced the need for specific training on suicide prevention in the mental health curriculum.",2020,"Our results showed that willingness to treat was significantly lower and the likelihood of referring out was significantly higher among therapists in the suicidal patient condition, relative to the depressive patient condition.","['Mental health professionals (N\u2009=\u2009249) completed a questionnaire that presented a vignette of a hypothetical patient referred for psychological treatment', ""Hypothetical Patients' Suicidal Severity on Therapists' Willingness to Treat""]",['specific training'],[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0523167,"Our results showed that willingness to treat was significantly lower and the likelihood of referring out was significantly higher among therapists in the suicidal patient condition, relative to the depressive patient condition.","[{'ForeName': 'Yossi', 'Initials': 'Y', 'LastName': 'Levi-Belz', 'Affiliation': ''}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Barzilay', 'Affiliation': ''}, {'ForeName': 'Dorin', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Or', 'Initials': 'O', 'LastName': 'David', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2019.1632233']
618,31701524,Proposed Therapeutic Range of Treosulfan in Reduced Toxicity Pediatric Allogeneic Hematopoietic Stem Cell Transplant Conditioning: Results From a Prospective Trial.,"Treosulfan is given off-label in pediatric allogeneic hematopoietic stem cell transplant. This study investigated treosulfan's pharmacokinetics (PKs), efficacy, and safety in a prospective trial. Pediatric patients (n = 87) receiving treosulfan-fludarabine conditioning were followed for at least 1 year posttransplant. PKs were described with a two-compartment model. During follow-up, 11 of 87 patients died and 12 of 87 patients had low engraftment (≤ 20% myeloid chimerism). For each increase in treosulfan area under the curve from zero to infinity (AUC (0-∞)  ) of 1,000 mg hour/L the hazard ratio (95% confidence interval) for mortality increase was 1.46 (1.23-1.74), and the hazard ratio for low engraftment was 0.61 (0.36-1.04). A cumulative AUC (0-∞)  of 4,800 mg hour/L maximized the probability of success (> 20% engraftment and no mortality) at 82%. Probability of success with AUC (0-∞)  between 80% and 125% of this target were 78% and 79%. Measuring PK at the first dose and individualizing the third dose may be required in nonmalignant disease.",2020,hour/L maximized the probability of success (> 20% engraftment and no mortality) at 82%.,"['Pediatric patients (n\xa0=\xa087) receiving', 'Toxicity Pediatric Allogeneic Hematopoietic Stem Cell Transplant Conditioning', 'pediatric allogeneic hematopoietic stem cell transplant']",['treosulfan-fludarabine'],"['probability of success', 'hazard ratio for low engraftment', 'low engraftment', 'mortality increase']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0076959', 'cui_str': 'treosulfan'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",87.0,0.132641,hour/L maximized the probability of success (> 20% engraftment and no mortality) at 82%.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chiesa', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Standing', 'Affiliation': 'Pharmacy Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Winter', 'Affiliation': 'Chemical Pathology Department, Great Ormond Street Hospital for Children,, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Nademi', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Pinner', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kloprogge', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McLellen', 'Affiliation': 'Clinical Biochemistry, Integrated Laboratory Medicine Directorate, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Persis J', 'Initials': 'PJ', 'LastName': 'Amrolia', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Kanchan', 'Initials': 'K', 'LastName': 'Rao', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Lucchini', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Silva', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Ciocarlie', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Arina', 'Initials': 'A', 'LastName': 'Lazareva', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gennery', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Bilyana', 'Initials': 'B', 'LastName': 'Doncheva', 'Affiliation': 'Pharmacy Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cant', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hambleton', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Flood', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rogerson', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Devine', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Prunty', 'Affiliation': 'Chemical Pathology Department, Great Ormond Street Hospital for Children,, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heales', 'Affiliation': 'Chemical Pathology Department, Great Ormond Street Hospital for Children,, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Veys', 'Affiliation': 'Bone Marrow Transplantation Department, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Slatter', 'Affiliation': ""Bone Marrow Transplantation Department, Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1715']
619,31272251,"Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study.","This multicenter, double-blind, randomized study compared the efficacy, pharmacokinetics (PKs)/pharmacodynamics (PDs), safety and immunogenicity profile of RTXM83 vs. reference rituximab (R-rituximab), both with CHOP, as first-line treatment of diffuse large B-cell lymphoma (DLBCL). A total of 272 patients <65 years of age, with good prognosis (136 per arm) were randomized (1:1) to receive six cycles of either RTXM83 or R-rituximab. The primary efficacy endpoint was achieved (overall response rate of 83.6% for RTXM83 and 82.9% for R-rituximab) with a difference 0.7% between arms (95%CI: [-8.77% to 10.17%]) fulfilling the predefined non-inferiority margin (-13%). Similar number of patients reported at least one adverse event (AE) (131 per arm) or one serious AE (47 with RTXM83 and 45 with R-rituximab). Anti-drug antibody development was comparable between the arms. PK/PD secondary endpoint results support similarity between the compounds. RTXM83 exhibits non-inferior efficacy and similar safety/immunogenicity to R-rituximab, being an accessible alternative for the treatment of patients with previously untreated DLBCL.",2019,The primary efficacy endpoint was achieved (overall response rate of 83.6% for RTXM83 and 82.9% for R-rituximab) with a difference 0.7% between arms (95%CI: [-8.77% to 10.17%]) fulfilling the predefined non-inferiority margin (-13%).,"['diffuse large B-cell lymphoma', 'patients with previously untreated DLBCL', 'diffuse large B-cell lymphoma (DLBCL', '272 patients <65 years of age, with good prognosis (136 per arm']","['RTXM83 or R-rituximab', 'RTXM83', 'Rituximab biosimilar RTXM83', 'RTXM83 vs. reference rituximab (R-rituximab']","['efficacy, pharmacokinetics (PKs)/pharmacodynamics (PDs), safety and immunogenicity profile', 'overall response rate']","[{'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good (finding)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",272.0,0.199494,The primary efficacy endpoint was achieved (overall response rate of 83.6% for RTXM83 and 82.9% for R-rituximab) with a difference 0.7% between arms (95%CI: [-8.77% to 10.17%]) fulfilling the predefined non-inferiority margin (-13%).,"[{'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Candelaria', 'Affiliation': 'Instituto Nacional de Cancerologia, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Derlis E', 'Initials': 'DE', 'LastName': 'González', 'Affiliation': 'Instituto Privado de Hematología E Investigación Clínica (IPHIC), Asunción, Paraguay.'}, {'ForeName': 'Marcia Torresan', 'Initials': 'MT', 'LastName': 'Delamain', 'Affiliation': 'Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Daniel Oscar', 'Initials': 'DO', 'LastName': 'Bär', 'Affiliation': 'Hospital J.B. Iturraspe, Santa Fe, Argentina.'}, {'ForeName': 'Surender Kumar', 'Initials': 'SK', 'LastName': 'Beniwal', 'Affiliation': 'Acharya Tulsi Regional Cancer Treatment and Research Institute (RCC), S. P. Medical College and AG of Hospitals, Bikaner, India.'}, {'ForeName': 'Lokanatha', 'Initials': 'L', 'LastName': 'Dasappa', 'Affiliation': 'HCG Care Centre, Bangalore, India.'}, {'ForeName': 'David Hugo', 'Initials': 'DH', 'LastName': 'Flores', 'Affiliation': 'Hospital Ángel Padilla, Tucumán, Argentina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Querol', 'Affiliation': 'Veterans Memorial Medical Center (VMMC), Quezon City, Philippines.'}, {'ForeName': 'Toh See', 'Initials': 'TS', 'LastName': 'Guan', 'Affiliation': 'Hospital Sultanah Amina, Johor Bahru, Malaysia.'}, {'ForeName': 'Oleg Nikolaevich', 'Initials': 'ON', 'LastName': 'Lipatov', 'Affiliation': 'State Budgetary Healthcare Institution, Moscow, Russian Federation.'}, {'ForeName': 'Elena Mikhailovna', 'Initials': 'EM', 'LastName': 'Volodicheva', 'Affiliation': 'Tula Regional Clinical Hospital, Tula, Russian Federation.'}, {'ForeName': 'Moosa', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Chris Hani Baragwanath Hospital, Soweto, South Africa.'}, {'ForeName': 'Sayyed Reza', 'Initials': 'SR', 'LastName': 'Safaee Nodehi', 'Affiliation': 'Imam Khomeini Complex Hospital, Tehran, Iran.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fogliatto', 'Affiliation': 'Santa Casa de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Paravisini', 'Affiliation': 'mAbxience Research S.L., Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Perez Diaz', 'Affiliation': 'mAbxience Research S.L., Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia & lymphoma,['10.1080/10428194.2019.1633632']
620,31201057,Physician clinical decision support system prompts and administration of subsequent doses of HPV vaccine: A randomized clinical trial.,"BACKGROUND


HPV vaccine is effective in preventing several cancers and anogenital warts, yet rates of HPV vaccination series completion in the United States are low. A primary reason identified by parents for vaccinating children against HPV is a health care provider's recommendation. Although most clinicians embrace vaccine recommendations, they are not always carried out evenly and subsequent HPV vaccines are missed.
METHODS


Using an electronic health records-based decision support system (CHICA) clinicians were randomized to either usual practice or to receive an automated reminder to recommend the 2nd or 3rd dose of HPV vaccine. The reminder was delivered to clinicians of all intervention group eligible adolescents who had already initiated the vaccine series. Logistic regression models with generalized estimating equations were used for data analysis.
RESULTS


A total of 1285 clinical encounters were observed across 29 randomized pediatric providers over a 13-month time frame (50.7% control group, 49.3% intervention group). Overall, patients were 44.9% female, 59.4% Black, 22.1% Hispanic, and 48.8% were ages 11-12 yrs. Within the control group, 421 (64.7%) received a subsequent HPV vaccine, compared to 481 (75.9%) (OR: 1.72, (95% CI 1.35-2.19)). Adjusted analysis showed no difference between the groups (aOR 1.52 (95% CI 0.88-2.62)) or when examined by age (11-12yrs aOR 1.66, (95% CI 0.79-3.48)) and 13-17yrs (aOR 1.19, (95% CI 0.76-1.85)) or gender female (aOR 1.39 (95% CI 0.71-2.72)) and males (aOR 1.67 (95% CI 0.95-2.92)). When results were stratified by both age and gender, there was similarly no statistically significant effect between the two groups.
CONCLUSIONS


Automated physician reminders for subsequent 2nd and 3rd doses of HPV vaccination were used. Despite increased rates of vaccination in the intervention group, the differences did not reach the level of statistical significance. Future studies with multifaceted approaches may be needed to examine the efficacy of computer-based reminders.
CLINICAL TRIAL REGISTRATION


NCT02558803, ""HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3"".",2019,"Adjusted analysis showed no difference between the groups (aOR 1.52 (95% CI 0.88-2.62)) or when examined by age (11-12yrs aOR 1.66, (95% CI 0.79-3.48)) and 13-17yrs (aOR 1.19, (95% CI 0.76-1.85)) or gender female (aOR 1.39 (95% CI 0.71-2.72)) and males (aOR 1.67 (95% CI 0.95-2.92)).","['patients were 44.9% female, 59.4% Black, 22.1% Hispanic, and 48.8% were ages 11-12\u202fyrs', 'group eligible adolescents who had already initiated the vaccine series']","['HPV vaccine', 'subsequent HPV vaccine']",['rates of vaccination'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.195873,"Adjusted analysis showed no difference between the groups (aOR 1.52 (95% CI 0.88-2.62)) or when examined by age (11-12yrs aOR 1.66, (95% CI 0.79-3.48)) and 13-17yrs (aOR 1.19, (95% CI 0.76-1.85)) or gender female (aOR 1.39 (95% CI 0.71-2.72)) and males (aOR 1.67 (95% CI 0.95-2.92)).","[{'ForeName': 'Tracey A', 'Initials': 'TA', 'LastName': 'Wilkinson', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: tracwilk@iu.edu.""}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Dixon', 'Affiliation': 'Indiana Univ, Fairbanks School of Public Health, Department of Epidemiology, 1050 Wishard Blvd, RG5, INpolis, IN 46202, United States; Regenstreif Institute, Center for Biomedical Informatics, 1101 W. 10th St., Indianapolis, IN 46202, United States. Electronic address: bedixon@regenstrief.org.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Indiana University School of Medicine, Department of Biostatistics, 410 W. 10th St., Suite 3000, Indianapolis, IN 46202, United States.'}, {'ForeName': 'Wanzhu', 'Initials': 'W', 'LastName': 'Tu', 'Affiliation': 'Regenstreif Institute, Center for Biomedical Informatics, 1101 W. 10th St., Indianapolis, IN 46202, United States; Indiana University School of Medicine, Department of Biostatistics, 410 W. 10th St., Suite 3000, Indianapolis, IN 46202, United States. Electronic address: wtu1@iu.edu.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Lindsay', 'Affiliation': 'Center for Observational and Real-World Evidence, Merck & Co., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, United States. Electronic address: lindsabr@sas.upenn.edu.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Sheley', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: msheley@iu.edu.""}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Dugan', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: tmdugan@iu.edu.""}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Church', 'Affiliation': 'Regenstreif Institute, Center for Biomedical Informatics, 1101 W. 10th St., Indianapolis, IN 46202, United States. Electronic address: akchurch@iupui.edu.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Downs', 'Affiliation': ""Indiana University School of Medicine, Department of Pediatrics-Children's Health Services Research, 410 W. 10th Street, Suite 2000, Indianapolis, IN 46202, United States. Electronic address: stmdowns@iu.edu.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Zimet', 'Affiliation': 'Indiana Univ. School of Medicine, Dept. of Pediatrics-Adolescent Medicine, 410 W. 10th St., Suite 1001, Indianapolis, IN 46202, United States. Electronic address: gzimet@iu.edu.'}]",Vaccine,['10.1016/j.vaccine.2019.05.004']
621,31838759,Changes in young children's oral health-related behaviours and caregiver knowledge: A cluster randomized controlled trial in Brazil.,"OBJECTIVE


To evaluate the effectiveness of an intervention to improve young children's oral health-related behaviours and caregiver knowledge.
METHODS


This paper reports on findings from a cluster randomized controlled trial, 12 months after of baseline, conducted in Pelotas, Southern Brazil. Two Primary Healthcare Centers (PHCs) and 170 caregiver-child dyads were assigned to an intervention group, and two PHCs and 174 dyads were assigned to a control group. Children's oral hygiene behaviours, sugar consumption and use of dental services were the outcomes analysed as well as changes in caregiver knowledge. The impact of the intervention was assessed using multilevel mixed-effects model regressions and the change rate ratios (IRR) were expressed.
RESULTS


There were positive and significant changes in favour of the intervention group in children's oral hygiene behaviours, use of dental services, and caregivers' knowledge of oral health. For example, children in the intervention group were more likely to have brushed with fluoride toothpaste at least two times a day (IRR 1.43, 95% CI 1.06-1.92), to have brushed their teeth before bedtime (IRR 1.37, 95% CI 1.02-1.84), and to have used dental services for preventive care (IRR 2.54, 95% CI 2.02-3.19) than children in the control group.
CONCLUSION


This intervention had positive effects on children's oral health-related behaviours and caregivers' oral health knowledge.",2020,"There were positive and significant changes in favour of the intervention group in children's oral hygiene behaviours, use of dental services, and caregivers' knowledge of oral health.","['Two Primary Healthcare Centers (PHCs) and 170 caregiver-child dyads', ""children's oral health-related behaviours and caregivers' oral health knowledge"", '12\xa0months after of baseline, conducted in Pelotas, Southern Brazil', ""young children's oral health-related behaviours and caregiver knowledge""]",['fluoride toothpaste'],"[""Children's oral hygiene behaviours, sugar consumption and use of dental services"", 'change rate ratios (IRR', ""children's oral hygiene behaviours, use of dental services, and caregivers' knowledge of oral health""]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]","[{'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0029162'}]",174.0,0.178351,"There were positive and significant changes in favour of the intervention group in children's oral hygiene behaviours, use of dental services, and caregivers' knowledge of oral health.","[{'ForeName': 'Aryane Marques', 'Initials': 'AM', 'LastName': 'Menegaz', 'Affiliation': 'Graduate School of Dentistry, Pelotas Federal University, Pelotas, Brazil.'}, {'ForeName': 'Luciana de Ávila', 'Initials': 'LÁ', 'LastName': 'Quevedo', 'Affiliation': 'Graduate School of Health and Behavior, Pelotas Catholic University, Pelotas, Brazil.'}, {'ForeName': 'Ludmila Correa', 'Initials': 'LC', 'LastName': 'Muniz', 'Affiliation': 'Graduate School of Nutrition, Pelotas Federal University, Pelotas, Brazil.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Finlayson', 'Affiliation': 'School of Public Health, San Diego State University and the Institute for Behavioral and Community Health, San Diego, CA, USA.'}, {'ForeName': 'Guadalupe X', 'Initials': 'GX', 'LastName': 'Ayala', 'Affiliation': 'School of Public Health, San Diego State University and the Institute for Behavioral and Community Health, San Diego, CA, USA.'}, {'ForeName': 'Andreia Morales', 'Initials': 'AM', 'LastName': 'Cascaes', 'Affiliation': 'Graduate School of Dentistry, Pelotas Federal University, Pelotas, Brazil.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12507']
622,30929973,Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial.,"BACKGROUND


The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary intervention (PCI) prior to CABG was associated with worse prognosis.
OBJECTIVES


The main purpose of this study was to analyse if prior PCI influenced outcomes in STICH.
METHODS AND RESULTS


Patients in the STICH trial (n = 1212), followed for a median time of 9.8 years, were included in the present analyses. In the total population, 156 had a prior PCI (74 and 82, respectively, in the MED and CABG groups). In those with vs. without prior PCI, the adjusted hazard-ratios (aHRs) were 0.92 (95% CI = 0.74-1.15) for all-cause mortality, 0.85 (95% CI = 0.64-1.11) for CV mortality, and 1.43 (95% CI = 1.15-1.77) for CV hospitalization. In the group randomized to CABG without prior PCI, the aHRs were 0.82 (95% CI = 0.70-0.95) for all-cause mortality, 0.75 (95% CI = 0.62-0.90) for CV mortality and 0.67 (95% CI = 0.56-0.80) for CV hospitalization. In the group randomized to CABG with prior PCI, the aHRs were 0.76 (95% CI = 0.50-1.15) for all-cause mortality, 0.81 (95% CI = 0.49-1.36) for CV mortality and 0.61 (95% CI = 0.41-0.90) for CV hospitalization. There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05).
CONCLUSION


In the STICH trial, prior PCI did not affect the outcomes of patients whether they were treated medically or surgically, and the superiority of CABG over MED remained unchanged regardless of prior PCI.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov; Identifier: NCT00023595.",2019,"There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05).
","['patients with left ventricular ejection fraction (LVEF) ≤35', 'Patients in the STICH trial (n\u202f=\u202f1212), followed for a median time of 9.8\u202fyears, were included in the present analyses']","['CABG', 'coronary artery bypass plus medical treatment (CABG']","['adjusted hazard-ratios (aHRs', 'CV mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.177077,"There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05).
","[{'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. Electronic address: jose.nicolau@incor.usp.br.'}, {'ForeName': 'Susanna R', 'Initials': 'SR', 'LastName': 'Stevens', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Fabio B', 'Initials': 'FB', 'LastName': 'Jatene', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luis A O', 'Initials': 'LAO', 'LastName': 'Dallan', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Luiz A F', 'Initials': 'LAF', 'LastName': 'Lisboa', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Haissam', 'Initials': 'H', 'LastName': 'Haddad', 'Affiliation': 'Department of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'E Marc', 'Initials': 'EM', 'LastName': 'Jolicoeur', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Quebec, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': 'Department of Cardiothoracic Surgery, University of Jena, Jena, Germany.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Michler', 'Affiliation': 'Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Maddury', 'Affiliation': 'Department of Cardiology, Nizams Institute of Medical Sciences, Hyderabad, India.'}, {'ForeName': 'Imtiaz', 'Initials': 'I', 'LastName': 'Ali', 'Affiliation': 'Libin Cardiovascular Institute of Alberta, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Marek A', 'Initials': 'MA', 'LastName': 'Deja', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Quebec, Canada.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Hill', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.03.029']
623,31246370,"Clinical efficacy of a combined acceptance and commitment therapy, dialectical behavioural therapy, and functional analytic psychotherapy intervention in patients with borderline personality disorder.","OBJECTIVE


Borderline personality disorder (BPD) consists of a persistent pattern of instability in affective regulation, impulse control, interpersonal relationships, and self-image. Although certain forms of psychotherapy are effective, their effects are small to moderate. One of the strategies that have been proposed to improve interventions involves integrating the therapeutic elements of different psychotherapy modalities from a contextual behavioural perspective (ACT, DBT, and FAP).
METHODS


Patients (n = 65) attending the BPD Clinic of the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñíz in Mexico City who agreed to participate in the study were assigned to an ACT group (n = 22), a DBT group (n = 20), or a combined ACT + DBT + FAP therapy group (n = 23). Patients were assessed at baseline and after therapeutic trial on measures of BPD symptom severity, emotion dysregulation, experiential avoidance, attachment, control over experiences, and awareness of stimuli.
RESULTS


ANOVA analyses showed no differences between the three therapeutic groups in baseline measures. Results of the MANOVA model showed significant differences in most dependent measures over time but not between therapeutic groups.
CONCLUSIONS


Three modalities of brief, contextual behavioural therapy proved to be useful in decreasing BPD symptom severity and emotional dysregulation, as well as negative interpersonal attachment. These changes were related to the reduction of experiential avoidance and the acquisition of mindfulness skills in all treatment groups, which may explain why no differences between the three different intervention modalities were observed.
PRACTITIONER POINTS


Brief adaptations of acceptance and commitment therapy and dialectical behavioural therapy are effective interventions for BPD patients, in combined or isolated modalities, and with or without the inclusion of functional analytic psychotherapy. The reduction of experiential avoidance and the acquisition of mindfulness skills are related with the diminution of BPD symptoms severity, including emotional dysregulation and negative interpersonal attachment.",2020,"These changes were related to the reduction of experiential avoidance and the acquisition of mindfulness skills in all treatment groups, which may explain why no differences between the three different intervention modalities were observed.
","['BPD patients', 'Patients (n\xa0', '65) attending the BPD Clinic of the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñíz in Mexico City who agreed to participate in the study were assigned to an', 'patients with borderline personality disorder']","['DBT', 'ACT', 'combined ACT', '\xa0DBT\xa0+\xa0FAP therapy', 'combined acceptance and commitment therapy, dialectical behavioural therapy, and functional analytic psychotherapy intervention', 'acceptance and commitment therapy and dialectical behavioural therapy', 'contextual behavioural therapy']","['BPD symptom severity and emotional dysregulation', 'BPD symptoms severity, including emotional dysregulation and negative interpersonal attachment', 'experiential avoidance and the acquisition of mindfulness skills', 'BPD symptom severity, emotion dysregulation, experiential avoidance, attachment, control over experiences, and awareness of stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0178641,"These changes were related to the reduction of experiential avoidance and the acquisition of mindfulness skills in all treatment groups, which may explain why no differences between the three different intervention modalities were observed.
","[{'ForeName': 'Michel A', 'Initials': 'MA', 'LastName': 'Reyes-Ortega', 'Affiliation': 'Academic Coordination Department, Contextual Behavioral Science and Therapy Institute, Mexico City, Mexico.'}, {'ForeName': 'Edgar M', 'Initials': 'EM', 'LastName': 'Miranda', 'Affiliation': 'Clinic of Borderline Personality Disorder, Directorate of Clinical Services, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fresán', 'Affiliation': 'Laboratory of Clinical Epidemiology, Sub-directorate of Clinical Research, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Angélica N', 'Initials': 'AN', 'LastName': 'Vargas', 'Affiliation': 'Coordination Department of Clinical Services, Contextual Behavioral Science and Therapy Institute, Mexico City, Mexico.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Barragán', 'Affiliation': 'Grantholder of the National Council for Science and Technology (CONACYT) for a project of the Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Robles García', 'Affiliation': 'Center of Research on Global Mental Health, Department of Innovation and Global Health, Directorate of Epidemiological and Psychosocial Research, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Arango', 'Affiliation': 'Clinic of Borderline Personality Disorder, Directorate of Clinical Services, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}]",Psychology and psychotherapy,['10.1111/papt.12240']
624,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN


Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION


Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
625,31800053,A Forced Choice Procedure to Assess the Acute Relative Reinforcing Effects of Nicotine Dose Per Se in Humans.,"INTRODUCTION


A method to assess acute reinforcement due to nicotine may aid identification of doses needed to maintain dependence. After describing development of a forced choice procedure, results are presented from two studies using it to determine the relative reinforcing effects of nicotine dose per se.
METHODS


Choice between a higher vs. a very low or no nicotine option, via smoking (Study 1, n=59) and via nasal spray (Study 2, n=42), were assessed in non-treatment seeking dependent smokers abstinent overnight. Using a within-subject design, different nicotine levels for each product were administered under blind conditions, initially to assess their discriminability (Study 1: 1.3-17 mg/g each vs 0.4 mg/g nicotine Spectrum cigarettes; Study 2: 2.5 µg/kg vs 0 µg/kg nicotine per spray). At the end of sessions for each study, participants engaged in forced choice trials to assess preference, requiring a fixed number of puffs/sprays for one and/or the other.
RESULTS


Confirming the procedure's validity, choice of the higher nicotine option was significantly greater than that for the very low or no nicotine option in both studies. In Study 1, choice relative to 0.4 mg/g was greater for cigarettes ≥ 5.3 mg/g but not ≤ 2.3 mg/g (p=0.003 for the interaction of higher content vs 0.4 mg/g comparison). In Study 2, choice was greater for the nicotine vs. placebo spray (p<.005), as nicotine was preferred nearly twice as much as the placebo.
CONCLUSIONS


This forced choice procedure may efficiently determine the relative reinforcing value of a nicotine dose per se.
IMPLICATIONS


The forced choice procedure described here may identify nicotine doses that are acutely reinforcing in dependent smokers. A priori research of choice comparisons between small versus zero nicotine doses could inform clinical research in larger and more diverse samples to determine nicotine contents in cigarettes, and perhaps in other commercial products, that are not reinforcing and, thus, likely to reduce risk of their addictiveness. This procedure also may be applicable to assessing changes in acute nicotine reinforcement due to different product formulations, novel drugs, or other manipulations, perhaps helping inform development of new interventions for cessation or harm reduction.",2019,"In Study 2, choice was greater for the nicotine vs. placebo spray (p<.005), as nicotine was preferred nearly twice as much as the placebo.
","['Humans', 'Choice between a higher vs. a very low or no nicotine option, via smoking (Study 1, n=59) and via nasal spray (Study 2, n=42), were assessed in non-treatment seeking dependent smokers abstinent overnight']","['placebo', 'nicotine vs. placebo', 'Nicotine', 'nicotine']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]",[],,0.13249,"In Study 2, choice was greater for the nicotine vs. placebo spray (p<.005), as nicotine was preferred nearly twice as much as the placebo.
","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz224']
626,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
627,31804404,"A Prospective, Randomized Trial Comparing Respiratory Status During Anesthesia for Airway Stenting: Spontaneous Respiration Versus Controlled Ventilation With Muscle Relaxants.","BACKGROUND


Airway stenting is a procedure in which a stent is inserted into a stenotic site of the airway. The safest method of ventilation for airway stenting is controversial. A prospective randomized interventional study was conducted on airway stenting. We conducted this study to investigate whether controlled ventilation with muscle relaxants (MR) during airway stenting reduces the incidence of desaturation events (percutaneous oxygen saturation [SpO2] <95%) in comparison with spontaneous respiration (SP).
METHODS


Sixty-four patients were enrolled at our hospital between April 2016 and August 2018, and were randomly assigned to the controlled ventilation with MR group or SP group. For anesthesia, total intravenous anesthesia with propofol target-controlled infusion and remifentanil was performed. In the SP group, SP was maintained. In the MR group, a rigid bronchoscope was inserted after the administration of MR to perform controlled ventilation. The incidence of desaturation events was analyzed by logistic regression adjusted by the preoperative respiratory state and stenotic site of the airway.
RESULTS


The incidence of desaturation events in the SP and MR groups was 75.0% (24/32) and 9.7% (3/31), respectively, with an odds ratio of 0.04 (95% confidence interval, 0.01-0.16, reference = SP group; P < .001). In the SP group, the mean intraoperative pH was lower than that in the MR group (7.2 ± 0.1 vs 7.4 ± 0.1, respectively; P < .001). In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
CONCLUSIONS


Controlled ventilation with MR during airway stenting reduced the incidence of desaturation events, maintaining a favorable respiratory status.",2020,"In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
","['comparison with spontaneous respiration (SP', 'Sixty-four patients were enrolled at our hospital between April 2016 and August 2018']","['controlled ventilation with MR group or SP', 'propofol target-controlled infusion and remifentanil', 'rigid bronchoscope', 'controlled ventilation with muscle relaxants (MR']","['incidence of desaturation events', 'mean partial pressure of arterial carbon dioxide (PaCO2', 'mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio', 'mean intraoperative pH']","[{'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0179435', 'cui_str': 'Rigid bronchoscope (physical object)'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood (substance)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",64.0,0.0447255,"In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
","[{'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'From the *Department of Anesthesiology †Department of Clinical Research Planning and Management, Clinical Research Center ‡Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Namie', 'Initials': 'N', 'LastName': 'Somiya', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'M Saito', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kada', 'Affiliation': ''}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Oki', 'Affiliation': ''}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tomita', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004544']
628,31264773,The ARRIVE Trial: Interpretation from an Epidemiologic Perspective.,"The findings of the ARRIVE trial (A Randomized Trial of Induction Versus Expectant Management) were recently published. This multisite randomized trial was designed to provide evidence regarding whether labor induction or expectant management is associated with increased adverse perinatal outcomes and risk of cesarean birth among healthy nulliparous women at term. The trial reported that the primary outcome, a composite of adverse neonatal outcomes, was not significantly different between the 2 groups; the principal secondary outcome, cesarean birth, was significantly more common among women whose pregnancy was expectantly managed than among women whose labor was induced at 39 weeks. These results have the potential to change existing practice. Several aspects of the study design may influence its potential internal and external validity and should be considered in order to make sound causal inferences from this trial, which will in turn affect how its findings are translated to practice. Although chance and confounding are of minimal concern, given the sample size and randomization used in the study, selection bias may be a concern. Studies are vulnerable to selection bias when the sample population differs from eligible nonparticipants, including in randomized controlled trials. External validity is defined as the extent to which the study population and setting are representative of the larger source population the study intends to represent. External validity may be limited given the characteristics of the women enrolled in the ARRIVE trial and the practice settings where the study was conducted. This brief report provides concrete suggestions for further analyses that could help solidify conclusions from the trial, and for further research questions that will continue advancement toward answering this complex question of how best to manage labor and birth decisions at full term among low-risk women.",2019,"The trial reported that the primary outcome, a composite of adverse neonatal outcomes, was not significantly different between the 2 groups; the principal secondary outcome, cesarean birth, was significantly more common among women whose pregnancy was expectantly managed than among women whose labor was induced at 39 weeks.",['healthy nulliparous women at term'],[],"['composite of adverse neonatal outcomes', 'cesarean birth', 'adverse perinatal outcomes and risk of cesarean birth']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.1112,"The trial reported that the primary outcome, a composite of adverse neonatal outcomes, was not significantly different between the 2 groups; the principal secondary outcome, cesarean birth, was significantly more common among women whose pregnancy was expectantly managed than among women whose labor was induced at 39 weeks.","[{'ForeName': 'Suzan L', 'Initials': 'SL', 'LastName': 'Carmichael', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Snowden', 'Affiliation': 'School of Public Health, Oregon Health and Science University-Portland State University, Portland, Oregon.'}]",Journal of midwifery & women's health,['10.1111/jmwh.12996']
629,31880084,Clinical Effects of Oblique Lateral Interbody Fusion by Conventional Open versus Percutaneous Robot-Assisted Minimally Invasive Pedicle Screw Placement in Elderly Patients.,"OBJECTIVES


To compare the clinical outcomes of percutaneous robot-assisted minimally invasive pedicle screw insertion versus freehand fluoroscopy-assisted pedicle screw insertion using a traditional open technique in elderly patients undergoing an oblique lumbar interbody fusion (OLIF) procedure.
METHODS


Based on the inclusion and exclusion criteria, 80 patients with lumbar degenerative disease who attended the spinal surgery department of the Beijing Jishuitan Hospital between January 2017 and April 2018 were enrolled in the present study. Patients were randomized 1:1 to undergo percutaneous robot-assisted minimally invasive pedicle screw insertion (experimental group, n = 40) or freehand fluoroscopy-assisted pedicle screw insertion using a traditional open technique (control group, n = 40). Outcomes were accuracy of screw placement evaluated on postoperative CT using the modified Gertzbein and Robbins scale, operative time, blood loss, postoperative drainage, lower back and leg pain evaluated using a visual analogue scale (VAS), lumbar function evaluated using the Oswestry disability index (ODI), and complication rates.
RESULTS


A total of 344 vertebral pedicle screws were inserted: 170 screws in the experimental group, and 174 screws in the control group. Accurate screw placement was significantly higher in the experimental group (98.2% [167/170]) than in the control group (93.1% [162/174]). Clinical outcomes showed significant differences between the experimental and control groups in operative time, intraoperative blood loss, and postoperative VAS for lower back pain in the immediate postoperative period.
CONCLUSION


Robot-assisted pedicle screw insertion in OLIF is an effective strategy for the management of elderly patients with lumbar degenerative diseases.",2020,"Clinical outcomes showed significant differences between the experimental and control groups in operative time, intraoperative blood loss, and postoperative VAS for lower back pain in the immediate postoperative period.
","['Elderly Patients', 'elderly patients with lumbar degenerative diseases', '344 vertebral pedicle screws were inserted: 170 screws in the experimental group, and 174 screws in the control group', '80 patients with lumbar degenerative disease who attended the spinal surgery department of the Beijing Jishuitan Hospital between January 2017 and April 2018 were enrolled in the present study', 'elderly patients undergoing an oblique lumbar interbody fusion (OLIF) procedure']","['percutaneous robot-assisted minimally invasive pedicle screw insertion versus freehand fluoroscopy-assisted pedicle screw insertion', 'Oblique Lateral Interbody Fusion by Conventional Open versus', 'Robot-assisted pedicle screw insertion in OLIF', 'Percutaneous Robot-Assisted Minimally Invasive Pedicle Screw Placement', 'percutaneous robot-assisted minimally invasive pedicle screw insertion (experimental group, n = 40) or freehand fluoroscopy-assisted pedicle screw insertion using a traditional open technique (control']","['operative time, intraoperative blood loss, and postoperative VAS for lower back pain', 'accuracy of screw placement evaluated on postoperative CT using the modified Gertzbein and Robbins scale, operative time, blood loss, postoperative drainage, lower back and leg pain evaluated using a visual analogue scale (VAS), lumbar function evaluated using the Oswestry disability index (ODI), and complication rates', 'Accurate screw placement']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0442295', 'cui_str': 'Oblique lateral (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}]",344.0,0.0567868,"Clinical outcomes showed significant differences between the experimental and control groups in operative time, intraoperative blood loss, and postoperative VAS for lower back pain in the immediate postoperative period.
","[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}]",Orthopaedic surgery,['10.1111/os.12587']
630,31801578,The effects of maternity waiting homes on the health workforce and maternal health service delivery in rural Zambia: a qualitative analysis.,"BACKGROUND


Maternity waiting homes (MWHs) are a potential strategy to address low facility delivery rates resulting from access-associated barriers in resource-limited settings. Within a cluster-randomized controlled trial testing a community-generated MWH model in rural Zambia, we qualitatively assessed how MWHs affect the health workforce and maternal health service delivery at their associated rural health centers.
METHODS


Four rounds of in-depth interviews with district health staff (n = 21) and health center staff (n = 73) were conducted at intervention and control sites over 24 months. We conducted a content analysis using a mixed inductive-deductive approach. Data were interpreted through the lens of the World Health Organzation Health Systems Framework.
RESULTS


Nearly all respondents expressed challenges with understaffing and overwork and reported that increasing numbers of facility-based deliveries driven by MWHs contributed substantively to their workload. Women waiting at MWHs allow staff to monitor a woman's final stage of pregnancy and labor onset, detect complications earlier, and either more confidently manage those complications at the health center or refer to higher level care. District, intervention, and control site respondents passionately discussed this benefit over all time points, describing it as outweighing challenges of additional work associated with MWHs. Intervention site staff repeatedly discussed the benefit of MWHs in providing a space for postpartum women to wait after the first few hours of clinical observation through the first 48 h after delivery. Additionally, intervention site staff perceived the ability to observe women for longer before and after delivery allowed them to better anticipate and plan their own work, adjust their workloads and mindset accordingly, and provide better and more timely care. When understaffing and overwork were frequently discussed, this satisfaction in providing better care was a meaningful departure.
CONCLUSIONS


MWHs may benefit staff at rural health centers and the health system more broadly, allowing for the provision of more timely and comprehensive obstetric care. We recommend future studies consider how MWHs impact the workforce, operations, and service delivery at their associated health facilities. Considering the limited numbers of skilled birth attendants available in rural Zambia, it is important to strategically select locations for new MWHs.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02620436. Registered December 3, 2015, https://clinicaltrials.gov/ct2/show/NCT02620436.",2019,"District, intervention, and control site respondents passionately discussed this benefit over all time points, describing it as outweighing challenges of additional work associated with MWHs.","['maternity waiting homes on the health workforce and maternal health service delivery in rural Zambia', 'rural Zambia', 'Four rounds of in-depth interviews with district health staff (n = 21) and health center staff (n = 73', 'Maternity waiting homes (MWHs']",[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0018721', 'cui_str': 'Health Manpower'}, {'cui': 'C0024922', 'cui_str': 'Maternal Health Services'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]",[],[],,0.113438,"District, intervention, and control site respondents passionately discussed this benefit over all time points, describing it as outweighing challenges of additional work associated with MWHs.","[{'ForeName': 'Jeanette L', 'Initials': 'JL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA. jlkaiser@bu.edu.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Thandiwe', 'Initials': 'T', 'LastName': 'Ngoma', 'Affiliation': 'Department of Research, Right to Care Zambia, Lusaka, Zambia.'}, {'ForeName': 'Kathleen Lucile', 'Initials': 'KL', 'LastName': 'McGlasson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Biemba', 'Affiliation': 'National Health Research Authority, Pediatric Centre of Excellence, Lusaka, Zambia.'}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Misheck', 'Initials': 'M', 'LastName': 'Bwalya', 'Affiliation': 'Department of Research, Right to Care Zambia, Lusaka, Zambia.'}, {'ForeName': 'Maynards', 'Initials': 'M', 'LastName': 'Chasaya', 'Affiliation': 'Department of Research, Right to Care Zambia, Lusaka, Zambia.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}]",Human resources for health,['10.1186/s12960-019-0436-7']
631,30964820,Randomized Controlled Trial of Oropharyngeal Colostrum Administration in Very-low-birth-weight Preterm Infants.,"OBJECTIVE


The purpose of this study was to evaluate the effects of oropharyngeal colostrum administration in the incidence of late-onset clinical and proven sepsis and in concentrations of immunoglobulin A (IgA) in very-low-birth-weight (VLBW) infants.
METHODS


We conducted a double-blinded, randomized, placebo-controlled trial and assigned 113 VLBW infants to receive 0.2 mL of maternal colostrum or sterile water (placebo) via oropharyngeal route every 2 hours for 48 hours, beginning in the first 48 to 72 hours of life. Neonates of both groups were fed breast milk from the first 3 days of life until a volume of at least 100 mL · kg · day. IgA was measured in serum and urine before and after treatment. Clinical data during hospitalization were collected.
RESULTS


We found no statistically significant differences between colostrum and placebo groups in the incidence of late-onset clinical sepsis (odds ratio 0.7602; CI 95% 0.3-1.6) and proven sepsis (odds ratio 0.7028; CI 95% 0.3-1.6). The measurement of IgA was similar in serum before (P value 0.87) and after treatment (P value 0.26 day 4 and 0.77 day 18). No differences were also observed in IgA in urine before (P value 0.8) and after treatment (P value 0.73 day 4 and 0.52).
CONCLUSIONS


This study could not confirm the hypothesis that oropharyngeal administration of maternal colostrum to VLBW could reduce the incidence of late-onset sepsis and increase the levels of IgA. We believe that this finding can be justified by the practice of feeding VLBW infants exclusively with breast milk in the first days of life and reinforces the prior knowledge of the importance of early nutrition, especially, with human milk. It also suggests that oropharyngeal administration of colostrum should be reserved for neonates who cannot be fed in first few days of life.",2019,The measurement of IgA was similar in serum before (P value 0.87) and after treatment (P value 0.26 day 4 and 0.77 day 18).,"['113 VLBW infants to receive', 'Very-low-birth-weight Preterm Infants']","['oropharyngeal colostrum administration', '0.2\u200amL of maternal colostrum or sterile water (placebo', 'placebo', 'Oropharyngeal Colostrum Administration']","['incidence of late-onset clinical sepsis', 'IgA in urine', 'proven sepsis', 'levels of IgA']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C3164780', 'cui_str': 'Clinical sepsis (disorder)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0042037'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",113.0,0.394975,The measurement of IgA was similar in serum before (P value 0.87) and after treatment (P value 0.26 day 4 and 0.77 day 18).,"[{'ForeName': 'Daniela M L M', 'Initials': 'DMLM', 'LastName': 'Ferreira', 'Affiliation': 'Division of Neonatology, Department of Pediatrics.'}, {'ForeName': 'Angela M M', 'Initials': 'AMM', 'LastName': 'Oliveira', 'Affiliation': 'Human Milk Bank, Clinics Hospital.'}, {'ForeName': 'Débora V', 'Initials': 'DV', 'LastName': 'de Leves', 'Affiliation': 'Faculty of Medicine.'}, {'ForeName': 'Érica B', 'Initials': 'ÉB', 'LastName': 'de Bem', 'Affiliation': 'Faculty of Medicine.'}, {'ForeName': 'Giovana G', 'Initials': 'GG', 'LastName': 'Fatureto', 'Affiliation': 'Faculty of Medicine.'}, {'ForeName': 'Natássia F', 'Initials': 'NF', 'LastName': 'Navarro', 'Affiliation': 'Faculty of Medicine.'}, {'ForeName': 'Nathália G', 'Initials': 'NG', 'LastName': 'Afonso', 'Affiliation': 'Faculty of Medicine.'}, {'ForeName': 'Fernanda M', 'Initials': 'FM', 'LastName': 'Santiago', 'Affiliation': 'Laboratory of Immunology, Biological Science Institute, Federal University of Uberlândia, Minas Gerais, Uberlândia.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Mineo', 'Affiliation': 'Laboratory of Immunology, Biological Science Institute, Federal University of Uberlândia, Minas Gerais, Uberlândia.'}, {'ForeName': 'Mônica C', 'Initials': 'MC', 'LastName': 'Sopelete', 'Affiliation': 'Laboratory of Immunology, Biological Science Institute, Federal University of Uberlândia, Minas Gerais, Uberlândia.'}, {'ForeName': 'Francisco E', 'Initials': 'FE', 'LastName': 'Martinez', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of São Paulo, Ribeirão Preto, São Paulo.'}, {'ForeName': 'Morun', 'Initials': 'M', 'LastName': 'Bernardino Neto', 'Affiliation': 'Engineering School, University of São Paulo, Lorena, Sao Paulo, Brazil.'}, {'ForeName': 'Vânia O S', 'Initials': 'VOS', 'LastName': 'Abdallah', 'Affiliation': 'Division of Neonatology, Department of Pediatrics.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002356']
632,31797160,Time Pressure During Primary Care Office Visits: a Prospective Evaluation of Data from the Healthy Work Place Study.,"BACKGROUND


The relationship between worklife factors, clinician outcomes, and time pressure during office visits is unclear.
OBJECTIVE


To quantify associations between time pressure, workplace characteristics ,and clinician outcomes.
DESIGN


Prospective analysis of data from the Healthy Work Place randomized trial.
PARTICIPANTS


168 physicians and advanced practice clinicians in 34 primary care practices in Upper Midwest and East Coast.
MAIN MEASURES AND METHODS


Time pressure was present when clinicians needed more time than allotted to provide quality care. Other metrics included work control, work pace (calm to chaotic), organizational culture and clinician satisfaction, stress, burnout, and intent to leave the practice. Hierarchical analysis assessed relationships between time pressure, organizational characteristics, and clinician outcomes. Adjusted differences between clinicians with and without time pressure were expressed as effect sizes (ESs).
KEY RESULTS


Sixty-seven percent of clinicians needed more time for new patients and 53% needed additional time for follow-up appointments. Time pressure in new patient visits was more prevalent in general internists than in family physicians (74% vs 55%, p < 0.05), women versus men (78% vs 55%, p < 0.01), and clinicians with larger numbers of complex psychosocial (81% vs 59%, p < 0.01) and Limited English Proficiency patients (95% vs 57%, p < 0.001). Time pressure in new patient visits was associated with lack of control, clinician stress, and intent to leave (ESs small to moderate, p < 0.05). Time pressure in follow-up visits was associated with chaotic workplaces and burnout (small to moderate ESs, p's < 0.05). Time pressure improved over time in workplaces with values alignment and an emphasis on quality.
CONCLUSIONS


Time pressure, more common in women and general internists, was related to chaos, control and culture, and stress, burnout, and intent to leave. Future studies should evaluate these findings in larger and more geographically diverse samples.",2020,"Time pressure in new patient visits was more prevalent in general internists than in family physicians (74% vs 55%, p < 0.05), women versus men (78% vs 55%, p < 0.01), and clinicians with larger numbers of complex psychosocial (81% vs 59%, p < 0.01) and Limited English Proficiency patients (95% vs 57%, p < 0.001).",['168 physicians and advanced practice clinicians in 34 primary care practices in Upper Midwest and East Coast'],[],"['Time pressure in new patient visits', 'time pressure, organizational characteristics, and clinician outcomes', 'Time pressure', 'complex psychosocial', 'work control, work pace (calm to chaotic), organizational culture and clinician satisfaction, stress, burnout, and intent to leave the practice']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0029242', 'cui_str': 'Corporate Culture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]",34.0,0.0397939,"Time pressure in new patient visits was more prevalent in general internists than in family physicians (74% vs 55%, p < 0.05), women versus men (78% vs 55%, p < 0.01), and clinicians with larger numbers of complex psychosocial (81% vs 59%, p < 0.01) and Limited English Proficiency patients (95% vs 57%, p < 0.001).","[{'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Prasad', 'Affiliation': 'Division of General Internal Medicine, Hennepin Healthcare, Minneapolis, MN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poplau', 'Affiliation': 'Division of General Internal Medicine, Hennepin Healthcare, Minneapolis, MN, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'School of Nursing, UW-Madison, Madison, WI, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Yale', 'Affiliation': 'University of Central Florida College of Medicine, Lake Nona, Orlando, FL, USA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Grossman', 'Affiliation': 'Cambridge Health Alliance, Cambridge, MA, USA.'}, {'ForeName': 'Anita B', 'Initials': 'AB', 'LastName': 'Varkey', 'Affiliation': 'Loyola University Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'University of Alabama, Tuscaloosa, AL, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Neprash', 'Affiliation': 'University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linzer', 'Affiliation': 'Division of General Internal Medicine, Hennepin Healthcare, Minneapolis, MN, USA. Mark.linzer@hcmed.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of general internal medicine,['10.1007/s11606-019-05343-6']
633,31525122,Cognitive and Affective Responses to Mass-media Based Genetic Risk Information in a Socio-demographically Diverse Sample of Smokers.,"Many individuals receive information about genomics from the mass media. When media reports are about conditions that are considered behavioral, such as smoking, they may negatively affect some health-promoting cognitions. We examined how informing adult smokers about the genetic basis for nicotine addiction influenced smoking-related health cognitions and affect and whether responses varied by socio-demographics or genetics beliefs. We recruited 392 smokers (Mage = 44.5, 52.8% African American, 51.3% no college experience, 66.2% women) from public locations in a mid-sized Midwestern city. They were randomly assigned to read a news article describing either a pharmacy's decision to stop selling tobacco (n = 78) or the discovery of a gene associated with increased risk of nicotine addiction and lung cancer (n = 314). Participants also completed a survey assessing socio-demographics, health cognitions (quit intentions, self-efficacy, response efficacy, perceived risk), affect (worry, anticipated regret), genetic determinism, and other genetics beliefs. ANOVAs revealed no statistically significant main effects of genetic information on any health cognitions or affects. Linear regressions revealed that socio-demographics and genetics beliefs moderated very few effects. This suggests that concerns that mass media-based dissemination of genetic discoveries may have detrimental effects on smoking-related cognitions and affects are likely unwarranted.",2019,ANOVAs revealed no statistically significant main effects of genetic information on any health cognitions or affects.,"['392 smokers (Mage\xa0=\xa044.5, 52.8% African American, 51.3% no college experience, 66.2% women) from public locations in a mid-sized Midwestern city', 'adult smokers', 'a Socio-demographically Diverse Sample of Smokers']",['Cognitive and Affective Responses to Mass-media Based Genetic Risk Information'],"['survey assessing socio-demographics, health cognitions (quit intentions, self-efficacy, response efficacy, perceived risk), affect (worry, anticipated regret), genetic determinism, and other genetics beliefs', 'health cognitions']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0024869', 'cui_str': 'Mass Media'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0949313', 'cui_str': 'Genetic Determinism'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",392.0,0.032683,ANOVAs revealed no statistically significant main effects of genetic information on any health cognitions or affects.,"[{'ForeName': 'Erika A', 'Initials': 'EA', 'LastName': 'Waters', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ackerman', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, Saint Louis, Missouri, USA.'}, {'ForeName': 'Courtney S', 'Initials': 'CS', 'LastName': 'Wheeler', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, Saint Louis, Missouri, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1664676']
634,31794684,Telemedicine Technologies and Tuberculosis Management: A Randomized Controlled Trial.,"Background:  Since 1990s, directly observed therapy (DOT) has been the standard-of-care for tuberculosis (TB), although it is cumbersome for patients as well as service providers. For raising implementation, an alternative delivery method with good potential is telehealth. The current study assessed the clinical and cost benefit of video directly observed therapy (VDOT), compared with DOT service.  Methods:  This prospective randomized controlled trial randomized adults with bacteriologically confirmed pulmonary TB to the intervention (VDOT) or control (DOT) group. The observation data for DOT and VDOT were updated by observers until the end of treatment or until the study concluded. The primary outcome was the TB treatment result defined by the World Health Organization (WHO) as used in some other studies conducted in North India and England as follows: good (cured and treatment completed), poor (death and failure), relocation, and lost to follow-up and others (refused, adverse reaction, not a TB case). Other secondary measures were treatment adherence, patient satisfaction, time and cost spent on DOT or VDOT.  Results:  On analyzing the results from 405 participants from each study arm, we found very high rates of treatment completion (96.1% with VDOT vs. 94.6% with DOT). The two observed treatment methods had no statistical differences, and all could accomplish their tasks well. Average time per dose observed was 16.5 min (standard deviation [SD] 12.1) for VDOT, while 44.1 min (SD 3.7) for DOT (including travel time),  p  < 0.01. And the cost incurred on VDOT was ￥34.3 (SD 3.8) manmo, which was statistically lower compared with ￥71.6 (SD 49.7) manmo in the DOT group,  p  < 0.01. Most of the patients in both groups believed that observed treatment (VDOT/DOT) helped them not to miss doses (185 [93.0%] vs. 171 [86.7%],  p  = 0.057). Patients in the VDOT group had a better experience compared with those in DOT group. They thought the way was convenient and comfortable (191 [96.0%] vs. 111 [56.6%],  p  < 0.001), would choose the original way if necessary (191 [96.0%] vs. 113 [57.7%],  p  < 0.001), and would recommend the method to other patients (191 [96.0%] vs. 113 [57.7%],  p  < 0.001).  Conclusion:  The study showed that VDOT enabled meaningful direct observation for TB patients through mobile devices, which was highly acceptable to patients and health care providers. It also saved time and is a cost-effective method, enabling the use of the saved money to other much-needed areas for TB.",2020,"The two observed treatment methods had no statistical differences, and all could accomplish their tasks well.",['adults with bacteriologically confirmed pulmonary TB to the intervention (VDOT) or control (DOT) group'],"['VDOT', 'Telemedicine Technologies and Tuberculosis Management', 'video directly observed therapy (VDOT']","['poor (death and failure), relocation, and lost to follow-up and others (refused, adverse reaction', 'treatment adherence, patient satisfaction, time and cost spent on DOT or VDOT', 'cost incurred on VDOT', 'TB treatment result defined by the World Health Organization (WHO']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",405.0,0.0959519,"The two observed treatment methods had no statistical differences, and all could accomplish their tasks well.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shandong Provincial Chest Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'Department of Respiration, Weihai Chest Hospital, Weihai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shandong Provincial Chest Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shandong Provincial Chest Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Chunting', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0190']
635,31758941,Do Regional Nerve Blocks Before Bimaxillary Surgery Reduce Postoperative Pain?,"PURPOSE


Any elective surgery should be as atraumatic to the patient as possible to allow for a comfortable postoperative recovery. The present study was performed to evaluate the efficacy of preoperative regional blocks in reducing pain, discomfort, and analgesic use in patients scheduled to undergo bimaxillary surgery.
PATIENTS AND METHODS


A prospective, double-blind, randomized controlled trial was conducted to include all patients aged 16 to 30 years requiring bimaxillary surgery. We excluded patients with syndromes and systemic conditions. The primary predictor variable was the maxillary and mandibular nerve blocks (extraoral lateral pterygoid method) administered preoperatively in the operating room using 0.25% bupivacaine hydrochloride. Standard anesthetic and postoperative protocols were followed. The primary outcome variable was postoperative pain. The secondary outcome variables were postoperative discomfort, analgesic consumption, duration of surgery, and blood loss. The unpaired t test and Mann-Whitney U test were used for statistical analyses, with P < .05 considered to indicate statistical significance.
RESULTS


A total of 110 patients were included in the study (55 in the control group and 55 in the test group), of whom 61 were female and 49 were male. Postoperative pain, recorded using a visual analog scale was significantly lower (P < .001) in the test group compared with the control group. Secondary outcome variables such as postoperative discomfort and analgesic consumption were also significantly lower in the test group. A significant positive correlation was present between the duration of surgery and pain measured at 6, 12, 24, and 48 hours postoperatively in both groups.
CONCLUSIONS


From our results, it can be established that the administration of preoperative regional blocks using 0.25% bupivacaine immediately before bimaxillary surgery can effectively minimize patients' postoperative pain, discomfort, and consumption of analgesics.",2020,"Postoperative pain, recorded using a visual analog scale was significantly lower (P < .001) in the test group compared with the control group.","['patients aged 16 to 30\xa0years requiring bimaxillary surgery', 'patients scheduled to undergo bimaxillary surgery', 'A total of 110 patients were included in the study (55 in the control group and 55 in the test group), of whom 61 were female and 49 were male', 'patients with syndromes and systemic conditions']","['bupivacaine', 'preoperative regional blocks', 'bupivacaine hydrochloride']","['postoperative pain', 'duration of surgery and pain', 'Postoperative pain', 'maxillary and mandibular nerve blocks (extraoral lateral pterygoid method', 'pain, discomfort, and analgesic use', 'postoperative discomfort, analgesic consumption, duration of surgery, and blood loss', 'Postoperative Pain', 'visual analog scale', 'postoperative discomfort and analgesic consumption', 'postoperative pain, discomfort, and consumption of analgesics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0394800', 'cui_str': 'Local anesthetic mandibular nerve block (procedure)'}, {'cui': 'C0442089', 'cui_str': 'Extraoral approach (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",110.0,0.172455,"Postoperative pain, recorded using a visual analog scale was significantly lower (P < .001) in the test group compared with the control group.","[{'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Shetty', 'Affiliation': 'Director, Nitte Meenakshi Institute of Craniofacial Surgery, K.S. Hegde Hospital; and Professor and Head, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Bylapudi', 'Initials': 'B', 'LastName': 'BhanuPrakash', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Surgical Fellow, Nitte Meenakshi Institute of Craniofacial Surgery, K.S. Hegde Hospital; and Lecturer, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Nanda', 'Initials': 'N', 'LastName': 'Kishore P', 'Affiliation': 'Head, Department of Craniofacial Orthodontics, and Professor, Department of Orthodontics and Dentofacial Orthopaedics, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Menon', 'Affiliation': 'Surgical Fellow, Nitte Meenakshi Institute of Craniofacial Surgery, K.S. Hegde Hospital; and Lecturer, Department of Oral and Maxillofacial Surgery, A.B. Shetty Memorial Institute of Dental Sciences, Mangalore, India. Electronic address: drakashmenon@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.10.014']
636,31237610,Self-Administered Acupressure for Chronic Low Back Pain: A Randomized Controlled Pilot Trial.,"Objective Chronic low back pain (CLBP) is associated with fatigue, pain, poor sleep, and disability. Acupressure is a low-risk treatment option used to manage symptoms in other groups, but its efficacy, particularly on fatigue and sleep, is unknown in CLBP. This study examined preliminary effects of two types of self-administered acupressure (relaxing and stimulating) on fatigue, pain, sleep, and reported disability. Methods A randomized pilot trial was conducted (N = 67) in which participants were randomized into six weeks of relaxing acupressure, stimulating acupressure, or usual care. Fatigue was measured by the Brief Fatigue Inventory, pain was measured by the Brief Pain Inventory, sleep was measured by the Pittsburgh Sleep Quality Index, and reported disability was measured by the Roland Morris Scale. Results Baseline characteristics were similar across groups. An intent-to-treat analysis using general linear models showed positive improvement in pain in acupressure groups compared with usual care. Pain was reduced by 35-36% in the acupressure groups. Improvement in fatigue was also found in stimulating acupressure compared with usual care. Adverse events were minimal and related to application of too much pressure. Discussion Although this was a small study, acupressure demonstrated promising preliminary support of efficacy for pain and fatigue reduction in this population.",2019,An intent-to-treat analysis using general linear models showed positive improvement in pain in acupressure groups compared with usual care.,"['Chronic Low Back Pain', 'Chronic low back pain (CLBP']","['relaxing acupressure, stimulating acupressure, or usual care', 'Self-Administered Acupressure', 'self-administered acupressure (relaxing and stimulating', 'Acupressure', 'acupressure']","['fatigue', 'Adverse events', 'pain', 'Pain', 'Brief Pain Inventory, sleep', 'Pittsburgh Sleep Quality Index, and reported disability', 'fatigue, pain, sleep, and reported disability', 'Fatigue', 'Brief Fatigue Inventory, pain']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.103295,An intent-to-treat analysis using general linear models showed positive improvement in pain in acupressure groups compared with usual care.,"[{'ForeName': 'Susan Lynn', 'Initials': 'SL', 'LastName': 'Murphy', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Richard Edmund', 'Initials': 'RE', 'LastName': 'Harris', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Nahid Roonizi', 'Initials': 'NR', 'LastName': 'Keshavarzi', 'Affiliation': 'Michigan Institute for Clinical and Health Research, Biostatistics Core.'}, {'ForeName': 'Suzanna Maria', 'Initials': 'SM', 'LastName': 'Zick', 'Affiliation': 'Department of Family Medicine.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz138']
637,30596830,Effects of Media Exposure to Conflicting Information About Mammography: Results From a Population-based Survey Experiment.,"BACKGROUND


Although there is growing theoretical and empirical support for the proposition that media exposure to conflicting health information negatively influences public understanding and behavior, few studies have causally linked exposure to conflict with undesirable outcomes. Such outcomes might be particularly likely in the context of mammography, given widespread media attention to conflicting recommendations about the age at and frequency with which average-risk women should be screened for breast cancer.
PURPOSE


The current study tests whether exposure to conflicting information about mammography negatively influences women's affective and cognitive responses and examines whether effects vary by socioeconomic position.
METHODS


We conducted an online survey experiment in 2016 with a population-based sample of U.S. women aged 35-55 (N = 1,474). Participants were randomly assigned to one of four conditions that differed in the level of conflict about mammography presented in a news story (no, low, medium, or high conflict), stratifying by poverty level.
RESULTS


Greater exposure to conflict increased women's negative emotional responses to the story they read, their confusion about and backlash toward cancer prevention recommendations and research, and their ambivalence about mammography and other types of cancer screening, though ambivalence leveled off at high levels of exposure. There was little evidence that effects varied across socioeconomic position.
CONCLUSIONS


Findings add to the growing evidence base documenting undesirable outcomes of exposure to conflicting health information. Future research should examine whether the negative affective and cognitive responses observed translate into behavior, which could have implications for both health campaigns and patient-provider communication.",2019,"Results


Greater exposure to conflict increased women's negative emotional responses to the story they read, their confusion about and backlash toward cancer prevention recommendations and research, and their ambivalence about mammography and other types of cancer screening, though ambivalence leveled off at high levels of exposure.","['2016 with a population-based sample of U.S. women aged 35-55 (N = 1,474']","['conflict about mammography presented in a news story (no, low, medium, or high conflict), stratifying by poverty level', 'Media Exposure to Conflicting Information About Mammography']","[""women's negative emotional responses""]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.0546215,"Results


Greater exposure to conflict increased women's negative emotional responses to the story they read, their confusion about and backlash toward cancer prevention recommendations and research, and their ambivalence about mammography and other types of cancer screening, though ambivalence leveled off at high levels of exposure.","[{'ForeName': 'Rebekah H', 'Initials': 'RH', 'LastName': 'Nagler', 'Affiliation': 'Hubbard School of Journalism & Mass Communication, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Marco C', 'Initials': 'MC', 'LastName': 'Yzer', 'Affiliation': 'Hubbard School of Journalism & Mass Communication, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Rothman', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kay098']
638,30891845,Pace capture and adenosine triphosphate provocation are complementary rather than mutually exclusive methods to ensure durable pulmonary vein isolation.,"INTRODUCTION


Adenosine triphosphate (ATP)-provoked dormant conduction (DC) and pacing for unexcitability are used to identify conduction gaps along the ablation lines after circumferential pulmonary vein isolation (CPVI). We aim to determine whether ATP provocation and pacing are interchangeable as endpoints for ablation of paroxysmal atrial fibrillation (PAF).
METHODS AND RESULTS


A total of 107 patients with PAF were randomly divided into two groups after completion of CPVI. In group I (A-P group, n = 53), ATP was administered first. If DC was uncovered, additional ablation was performed until ATP tests were negative. Bipolar pacing along the ablation line was performed subsequently. In group II (P-A group, n = 54), the same protocol was used, but the pacing and the ATP tests were performed in the opposite sequence. The 12-month ablation outcomes of all patients were compared with those of a historical control group of 107 patients with PAF in whom only ATP test was performed. Regardless of which test was performed first, the other modality still identified conduction gaps. In group I, pacing maneuvers identified gaps in 49% (n = 26) of patients who had negative ATP tests. In group II, ATP tests uncovered DC in 18.5% (n = 10) of patients in whom pacing identified no gaps. After 12 months, a higher proportion of patients (91.6%) were free from atrial tachyarrhythmias compared with the historical control group (81.3%; P = 0.031).
CONCLUSION


Pacing along the ablation lines and ATP provocation are complementary tests for evaluating the durability of CPVI and can lead to better long-term outcomes when used in combination.",2019,"In group I, pacing maneuvers identified gaps in 49% (n = 26) of patients who had negative ATP tests.","['107 patients with PAF in whom only ATP test was performed', '107 patients with PAF']","['ATP provocation and pacing', 'Adenosine triphosphate (ATP)-provoked dormant conduction (DC) and pacing', 'CPVI']",['free from atrial tachyarrhythmias'],"[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0449428', 'cui_str': 'Provocation (attribute)'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}]","[{'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}]",107.0,0.0150247,"In group I, pacing maneuvers identified gaps in 49% (n = 26) of patients who had negative ATP tests.","[{'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Zeng', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan-Jiang', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xian-Dong', 'Initials': 'XD', 'LastName': 'Yin', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'Liu', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xin-Chun', 'Initials': 'XC', 'LastName': 'Yang', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xing-Peng', 'Initials': 'XP', 'LastName': 'Liu', 'Affiliation': 'Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13901']
639,31236954,Effectiveness of the application of massage therapy and kinesitherapy by parents on premature neonates: A research protocol.,"AIM


The study aims to analyse the efficacy of massage therapy and kinesitherapy applied by parents of premature infants admitted to hospital.
BACKGROUND


Premature newborns suffer early somatic deprivation that has adverse effects on their growth and development and that also has a negative impact on the emotional state of their parents. Massage therapy and kinesitherapy is beneficial in alleviating somatic deficit and facilitates the bond between parents and newborns.
DESIGN


A quasi-experimental community intervention trial will be conducted in a neonatology unit.
METHODS


This study will compare the benefits of a 15-min massage protocol applied by parents with the usual medical and nursing care given by neonatal units for premature babies. The evaluation of neuromotor development will take place through the Spanish Premie-Neuro scale. The determination of weight, size, and head circumference will be based on the unit's usual procedures.
DISCUSSION


If the implementation of a massage therapy and kinesitherapy protocol is effective in promoting the growth and development of hospitalized premature infants, the results of this study could give an impetus for the inclusion of somatic stimulation in the usual nursing care given for preterm infants.
IMPACT


Prematurity and its associated morbidity pose a major global public health problem. Somatic and kinaesthetic stimulation has beneficial effects on anthropometric and neuromotor development in preterm infants. The results will have a positive impact on premature neonates and their families, both during the hospitalization, and a positive socio-economic effect throughout their lives (education, work, disability).
TRIAL REGISTRATION


NCT03704012.",2019,"The results will have a positive impact on premature neonates and their families, both during the hospitalization, as well as a positive socio-economic effect throughout their lives (education, work, disability).","['parents with the usual medical and nursing care provided by neonatal units for premature babies', 'parents of premature infants admitted to hospital', 'hospitalized premature infants', 'parents on premature neonates', 'preterm infants']","['Massage therapy and kinesitherapy', 'Somatic and kinesthetic stimulation', 'massage therapy and kinesitherapy protocol', 'massage therapy and kinesitherapy']","['determination of weight, size and head circumference']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0021294', 'cui_str': 'Premature infant (finding)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C3536731', 'cui_str': 'Massage Therapy'}, {'cui': 'C1096702', 'cui_str': 'Kinesiotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}]",,0.0219327,"The results will have a positive impact on premature neonates and their families, both during the hospitalization, as well as a positive socio-economic effect throughout their lives (education, work, disability).","[{'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Álvarez-Álvarez', 'Affiliation': 'Department of Nursing and Physiotherapy, University of León, León, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández-García', 'Affiliation': 'Division of Nursing, University Hospital of León, León, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gómez-Salgado', 'Affiliation': 'Department of Sociology, Social Work and Public Health, University of Huelva, Huelva, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Ordás', 'Affiliation': 'Division of Nursing, University Hospital of León, León, Spain.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Rodríguez-González', 'Affiliation': 'Premature Unit, University Hospital of León, León, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': 'Health and Podiatry Unit, Department of Heatlh Sciences, Faculty of Nursing and Podiatry, University of A Coruña, Campus of Esteiro, Ferrol, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14135']
640,31198103,Association of brain volume loss and long-term disability outcomes in patients with multiple sclerosis treated with teriflunomide.,"BACKGROUND


Teriflunomide 14 mg significantly reduced brain volume loss (BVL) and confirmed disability worsening (CDW) compared with placebo in the TEMSO core study.
OBJECTIVE


To investigate the relationship between BVL from Baseline to Year 2 in the TEMSO core study and long-term CDW (Year 7) in the TEMSO long-term extension (NCT00803049).
METHODS


Structural Image Evaluation using Normalization of Atrophy determined BVL. Long-term CDW was assessed by Expanded Disability Status Scale confirmed for 12 and 24 weeks. An additional analysis evaluated the relative contribution of BVL (Year 2) and other outcomes as potential mediators of the effect of teriflunomide 14 mg on 12-week CDW.
RESULTS


Patients with the least BVL were significantly less likely to have 12- and 24-week CDW at Year 7 compared with patients with the most BVL. A mediation analysis revealed that BVL (Year 2) explained 51.3% of the treatment effect on CDW; new or enlarging T 2w  lesions over 2 years explained 30.8%, and relapses in the first 2 years explained 38.5%.
CONCLUSIONS


These results highlight the potential predictive value of BVL earlier in the disease course on long-term disability outcomes. The mediation analysis suggests that teriflunomide may prevent disability worsening largely through its effects on BVL.",2020,"A mediation analysis revealed that BVL (Year 2) explained 51.3% of the treatment effect on CDW; new or enlarging T 2w  lesions over 2 years explained 30.8%, and relapses in the first 2 years explained 38.5%.
",['patients with multiple sclerosis treated with teriflunomide'],['placebo'],"['Expanded Disability Status Scale', 'brain volume loss (BVL) and confirmed disability worsening (CDW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.0435541,"A mediation analysis revealed that BVL (Year 2) explained 51.3% of the treatment effect on CDW; new or enlarging T 2w  lesions over 2 years explained 30.8%, and relapses in the first 2 years explained 38.5%.
","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'University Hospital Basel, Basel, Switzerland/ Department of Neurology, DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ernst-Wilhelm', 'Initials': 'EW', 'LastName': 'Radue', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gaetano', 'Affiliation': 'Medical Image Analysis Center, Basel, Switzerland/ Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mueller-Lenke', 'Affiliation': 'Medical Image Analysis Center, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wuerfel', 'Affiliation': 'Medical Image Analysis Center, Basel, Switzerland/ Department of Biomedical Engineering, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Poole', 'Affiliation': 'Global Scientific Communications, Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Cavalier', 'Affiliation': 'Global Scientific Communications, Sanofi, Cambridge, MA, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519855722']
641,31134640,"β-Hydroxy-β-methylbutyrate, Arginine, and Glutamine Complex on Muscle Volume Loss in Critically Ill Patients: A Randomized Control Trial.","BACKGROUND


β-Hydroxy-β-methylbutyrate (HMB), a metabolite of leucine, can strongly induce muscle protein synthesis. We evaluated the efficacy of HMB complex on muscle volume loss during critical care.
METHODS


For this prospective, single-center, randomized control trial, we created control and HMB groups by random assignment of intensive care unit (ICU) patients for whom enteral nutrition could be performed. From 164 ICU patients, 88 severely ill patients were included and assigned: 43 to control and 45 to HMB. From day 2 after admission, HMB group were administered 3 g HMB, 14 g arginine, and 14 g glutamine daily in addition to standard nutrition therapy. Early rehabilitation with electrical muscle stimulation was started from day 2 in both groups. As a primary outcome, we evaluated femoral muscle volume using computed tomography on days 1 and 10.
RESULTS


Femoral muscle volumes of 24 control and 26 HMB group participants were analyzed as per protocol. Volumes decreased significantly during days 1-10 (P < 0.0001). Volume loss rates were 14.4 ± 7.1% for control participants and 11.4 ± 8.1% for HMB participants (P = 0.18). In a subgroup of the sequential organ failure assessment scores <10, femoral muscle volume loss was 14.0 ± 6.9% for control participants and 8.7 ± 6.4% for HMB (P = 0.0474). Results of intention-to-treat analysis of the 2 groups showed no differences in basic characteristics or outcomes.
CONCLUSIONS


For critically ill patients, HMB complex supplementation from the acute phase of intensive care does not inhibit muscle volume loss.",2020,Volumes decreased significantly during days 1-10 (P < 0.0001).,"['164 ICU patients, 88 severely ill patients were included and assigned: 43 to control and 45 to HMB', 'Critically Ill Patients']","['HMB complex', 'β-Hydroxy-β-methylbutyrate, Arginine, and Glutamine Complex', 'β-Hydroxy-β-methylbutyrate (HMB']","['Volume loss rates', 'femoral muscle volume loss', 'femoral muscle volume using computed tomography on days 1 and 10']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",164.0,0.134446,Volumes decreased significantly during days 1-10 (P < 0.0001).,"[{'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kihata', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Hiromu', 'Initials': 'H', 'LastName': 'Naraba', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kanda', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sonoo', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Morimura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, The University of Tokyo Hospital, Bunkyo City, Tokyo, Japan.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1607']
642,31181244,Simultaneously applying cathodal tDCS with low frequency rTMS at the motor cortex boosts inhibitory aftereffects.,"BACKGROUND


Transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) can modulate cortical excitability. However, the combining effect of tDCS and rTMS at the same motor cortex is unknown.
NEW METHODS


We have recently developed a new stimulation protocol that simultaneously combines two well-documented methods. Eleven right-handed healthy subjects undertook four sessions at the left cortical representation area of right first dorsal interosseous muscle in randomized order, the order was counter balanced. Session one was the sham control without tDCS or rTMS. Session two involved cathodal tDCS with sham rTMS. Session three involved rTMS with sham tDCS. Session four was the combination of cathodal tDCS and rTMS(tDCS-rTMS). Cathodal tDCS was applied at 1 mA, and 1200 rTMS pulses were applied at 1 Hz with 90% resting motor threshold (RMT). All stimulation durations lasted for 20 min. RMT was monitored pre- and post-stimulation immediately after finishing the stimulation. Single pulse TMS induced MEP amplitudes were monitored before and after stimulation for 30 min afterwards.
RESULTS


Neither stimulus modality changed the value of RMT. As compared to sham stimulation, MEP amplitudes decreased in other three conditions. MEP amplitudes in tDCS-rTMS were much more inhibited than either tDCS or rTMS alone.
COMPARISON WITH EXISTING METHODS


We could reproduce inhibitory effect of 1 mA cathodal tDCS and 1 Hz rTMS in concordance with previous literature. The novel simultaneous tDCS-rTMS stimulation protocol can induce enhanced excitability change than either tDCS or rTMS.
CONCLUSIONS


Simultaneous application of cathodal tDCS with low frequency rTMS produces a stronger inhibitory effect.",2019,"As compared to sham stimulation, MEP amplitudes decreased in other three conditions.",['Eleven right-handed healthy subjects'],"['Cathodal tDCS', 'RMT', 'Transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS', 'cathodal tDCS and rTMS(tDCS-rTMS', 'tDCS and rTMS', 'rTMS with sham tDCS', 'cathodal tDCS with sham rTMS', 'tDCS or rTMS', 'sham control without tDCS or rTMS']",['MEP amplitudes'],"[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0277914,"As compared to sham stimulation, MEP amplitudes decreased in other three conditions.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhexue', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Penghui', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qilin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yicong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. Electronic address: linyc_1@163.com.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China. Electronic address: wangyuping01@sina.cn.'}]",Journal of neuroscience methods,['10.1016/j.jneumeth.2019.05.017']
643,31770068,Lot-to-lot consistency study of an  Escherichia coli -produced bivalent human papillomavirus vaccine in adult women: a randomized trial.,"An  Escherichia. coli -produced HPV-16/18 bivalent vaccine has been proved to be well-tolerated and highly efficacious against diseases associated with vaccine HPV types. As a part of the multi-center, randomized, double-blind phase III clinical trial, this lot-to-lot consistency study aimed to assess the safety and immunogenicity consistency of this novel HPV vaccine, which is also one of the objectives of the phase III trial. A total of 3689 healthy women aged 18-45 years were enrolled and randomly assigned 1:1:1 to three lots of the HPV vaccine groups. The primary outcomes were the IgG antibody level at 1 month after the last dose (month 7). In the immunogenicity per-protocol set (PPS), almost all of the participants seroconverted at month 7 and remained seropositive at month 42. For each paired comparison of the three lot groups, the two-sides of 90% CIs of GMC ratios for both IgG and neutralizing antibodies for HPV-16 and HPV-18 at month 7 were within the equivalence interval [0.5, 2]. Lot consistency was also demonstrated at month 42. The majority of recorded solicited reactions were mild or moderate. The incidences of solicited reactions of Lot 2 and Lot 3 were slightly higher than Lot 1. However, the incidences of solicited reactions of ≥ grade 3 and solicited reactions by symptoms were all similar among the three lot groups. None of the SAEs was considered related to vaccination by the investigator. In conclusion, this study demonstrates lot-to-lot consistency of the 3 consecutive lots of the  E. coli -produced HPV-16/18 bivalent vaccine.",2020,-produced HPV-16/18 bivalent vaccine has been proved to be well-tolerated and highly efficacious against diseases associated with vaccine HPV types.,"['adult women', '3689 healthy women aged 18-45 years']","['Escherichia coli -produced bivalent human papillomavirus vaccine', 'HPV vaccine', 'coli']","['IgG antibody level', 'solicited reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",3689.0,0.0706711,-produced HPV-16/18 bivalent vaccine has been proved to be well-tolerated and highly efficacious against diseases associated with vaccine HPV types.,"[{'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Su', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Bi-Zhen', 'Initials': 'BZ', 'LastName': 'Lin', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Food and Drug Control, Division of Respiratory Virus Vaccines , Beijing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Division of Respiratory Virus Vaccines , Beijing, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'You-Lin', 'Initials': 'YL', 'LastName': 'Qiao', 'Affiliation': 'National Cancer Center, National Center for Cancer Clinical Research, the Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College , Beijing, China.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, Jiangsu, China.'}, {'ForeName': 'Rong-Cheng', 'Initials': 'RC', 'LastName': 'Li', 'Affiliation': 'Center for Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention , Nanning, Guangxi, China.'}, {'ForeName': 'Si-Jie', 'Initials': 'SJ', 'LastName': 'Zhuang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Zi-Zheng', 'Initials': 'ZZ', 'LastName': 'Zheng', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Division of Respiratory Virus Vaccines , Beijing, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1691413']
644,31687769,Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers.,"INTRODUCTION


Smoking is a key determinant of mortality among people living with HIV (PLWH).
METHODS


To better understand the effects of smoking cessation interventions in PLWH, we conducted a pooled analysis of four randomized controlled trials of hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART). In each study, cigarette smokers were randomly assigned to usual care or a smoking cessation intervention. The primary outcome was self-reported past 30-day tobacco abstinence at 6-month follow-up. Abstinence rates were compared between PLWH and participants without HIV and by treatment arm, using both complete-case and intention-to-treat analyses. Multivariable logistic regression was used to determine the effect of HIV status on 6-month tobacco abstinence and to determine predictors of smoking cessation within PLWH.
RESULTS


Among 5550 hospitalized smokers, there were 202 (3.6%) PLWH. PLWH smoked fewer cigarettes per day and were less likely to be planning to quit than smokers without HIV. At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%). In multivariable regression analysis, HIV status was not significantly associated with smoking cessation at 6 months. Among PLWH, confidence in quitting was the only clinical factor independently associated with smoking cessation (OR 2.0, 95% CI = 1.4 to 2.8, p < .01).
CONCLUSIONS


HIV status did not alter likelihood of quitting smoking after hospital discharge, whether or not the smoker was offered a tobacco cessation intervention, but power was limited to identify potentially important differences.
IMPLICATIONS


PLWH had similar quit rates to participants without HIV following a hospital-initiated smoking cessation intervention. The findings suggest that factors specific to HIV infection may not influence response to smoking cessation interventions and that all PLWH would benefit from efforts to assist in quitting smoking.
TRIAL REGISTRATION


(1) Using ""warm handoffs"" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial: NCT01305928. (2) Web-based smoking cessation intervention that transitions from inpatient to outpatient: NCT01277250. (3) Effectiveness of smoking-cessation interventions for urban hospital patients: NCT01363245. (4) Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (HelpingHAND2): NCT01714323.",2020,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","['Hospitalized Smokers (HelpingHAND2', 'people living with HIV (PLWH', '5550 hospitalized smokers', 'hospitalized smokers with tobacco treatment after discharge', 'hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART', 'HIV-Infected Smokers', 'participants without HIV following a hospital-initiated smoking cessation intervention', 'urban hospital patients', 'cigarette smokers']","['usual care or a smoking cessation intervention', 'Post-Discharge Strategies', 'PLWH', 'smoking-cessation interventions', 'Smoking Cessation Interventions']","['Abstinence rates', 'smoking cessation', 'self-reported past 30-day tobacco abstinence', 'cessation rates', 'quit rates']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035168'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",,0.0487106,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Triant', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Grossman', 'Affiliation': 'Cambridge Health Alliance, Somerville, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas, Nashville, TN.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Division of General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Harrington', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz168']
645,32410463,Empagliflozin in Heart Failure: Diuretic and Cardiorenal Effects.,"BACKGROUND


Sodium-glucose cotransporter-2 inhibitors improve heart failure-related outcomes. The mechanisms underlying these benefits are not well understood, but diuretic properties may contribute. Traditional diuretics such as furosemide induce substantial neurohormonal activation, contributing to the limited improvement in intravascular volume often seen with these agents. However, the proximal tubular site of action of the sodium-glucose cotransporter-2 inhibitors may help circumvent these limitations.
METHODS


Twenty patients with type 2 diabetes mellitus and chronic, stable heart failure completed a randomized, placebo-controlled crossover study of empagliflozin 10 mg daily versus placebo. Patients underwent an intensive 6-hour biospecimen collection and cardiorenal phenotyping at baseline and again after 14 days of study drug. After a 2-week washout, patients crossed over to the alternate therapy with the above protocol repeated.
RESULTS


Oral empagliflozin was rapidly absorbed as evidenced by a 27-fold increase in urinary glucose excretion by 3 hours ( P <0.0001). Fractional excretion of sodium increased significantly with empagliflozin monotherapy versus placebo (fractional excretion of sodium, 1.2±0.7% versus 0.7±0.4%;  P =0.001), and there was a synergistic effect in combination with bumetanide (fractional excretion of sodium, 5.8±2.5% versus 3.9±1.9%;  P =0.001). At 14 days, the natriuretic effect of empagliflozin persisted, resulting in a reduction in blood volume (-208 mL [interquartile range, -536 to 153 mL] versus -14 mL [interquartile range, -282 to 335 mL];  P =0.035) and plasma volume (-138 mL, interquartile range, -379 to 154±453 mL;  P =0.04). This natriuresis was not, however, associated with evidence of neurohormonal activation because the change in norepinephrine was superior ( P =0.02) and all other neurohormones were similar ( P <0.34) during the empagliflozin versus placebo period. Furthermore, there was no evidence of potassium wasting ( P =0.20) or renal dysfunction ( P >0.11 for all biomarkers), whereas both serum magnesium ( P <0.001) and uric acid levels ( P =0.008) improved.
CONCLUSIONS


Empagliflozin causes significant natriuresis, particularly when combined with loop diuretics, resulting in an improvement in blood volume. However, off-target electrolyte wasting, renal dysfunction, and neurohormonal activation were not observed. This favorable diuretic profile may offer significant advantage in the management of volume status in patients with heart failure and may represent a mechanism contributing to the superior long-term heart failure outcomes observed with these agents. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03027960.",2020,"Fractional excretion of sodium (FENa) increased significantly with empagliflozin monotherapy vs. placebo (FENa 1.2 ± 0.7% vs. 0.7 ± 0.4% p=0.001) and there was a synergistic effect in combination with bumetanide (FENa 5.8 ± 2.5% vs. 3.9 ± 1.9%, p=0.001).","['HF patients', '20 patients with type-2 diabetes and chronic, stable HF completed a randomized', 'Heart Failure']","['bumetanide', 'empagliflozin', 'empagliflozin monotherapy vs. placebo', ""Sodium-glucose cotransporter-2 inhibitors (SGLT-2i's"", 'intensive 6-hour biospecimen collection and cardio-renal phenotyping', 'Empagliflozin', 'Oral empagliflozin', 'empagliflozin vs. placebo', 'empagliflozin 10mg daily vs. placebo', 'placebo']","['plasma volume', 'urinary glucose excretion', 'serum magnesium (p<0.001) and uric acid levels', 'synergistic effect', 'Fractional excretion of sodium (FENa', 'blood volume', 'renal dysfunction', 'renal dysfunction, and neurohormonal activation', 'natriuretic effect', 'potassium wasting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3179308', 'cui_str': 'Natriuretic Effects'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",20.0,0.14824,"Fractional excretion of sodium (FENa) increased significantly with empagliflozin monotherapy vs. placebo (FENa 1.2 ± 0.7% vs. 0.7 ± 0.4% p=0.001) and there was a synergistic effect in combination with bumetanide (FENa 5.8 ± 2.5% vs. 3.9 ± 1.9%, p=0.001).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Veena S', 'Initials': 'VS', 'LastName': 'Rao', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ivey-Miranda', 'Affiliation': 'Hospital de Cardiologia, Instituto Mexicano del Seguro Social, Mexico City, Mexico (J.I.-M.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maulion', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Suda', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, New York (N.S.).'}, {'ForeName': 'Krishmita', 'Initials': 'K', 'LastName': 'Siwakoti', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, University of Alabama at Birmingham (K.S.).'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Riello', 'Affiliation': 'Division of Pharmacy (R.R.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Bellumkonda', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN (Z.C.).'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN (S.C.).'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale School of Nursing, West Haven, CT (S.J.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'F Perry', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Clinical and Translational Research Accelerator (F.P.W.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson (J.B.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology (S.E.I.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.045691']
646,31790546,Effectiveness of a Brief Self-determination Theory-Based Smoking Cessation Intervention for Smokers at Emergency Departments in Hong Kong: A Randomized Clinical Trial.,"Importance


Clinicians have an opportunity to provide smoking cessation interventions to smokers who present to emergency departments (EDs). The effectiveness of a brief intervention based on self-determination theory for smoking cessation is uncertain.
Objective


To examine the effectiveness of a brief intervention based on self-determination theory for smoking cessation (immediate or progressive) among Chinese smokers presenting at EDs in Hong Kong.
Design, Setting, and Participants


This single-blind, multicenter intent-to-treat randomized clinical trial was conducted at the EDs of 4 major acute care hospitals in different districts of Hong Kong. In total, 1571 smokers 18 years or older who presented at 4 major EDs between July 4, 2015, and March 17, 2017, were randomized into an intervention group (n = 787) and a control group (n = 784).
Interventions


The intervention group received brief advice (about 1 minute) and could choose their own quit schedules (immediate or progressive). The control group received a smoking cessation leaflet.
Main Outcomes and Measures


Follow-up visits were conducted at 1, 3, 6, and 12 months. The primary outcome measure, by intent to treat, was biochemically validated abstinence at 6 months.
Results


Participants (N = 1571) included 1381 men (87.9%); the mean (SD) age at baseline was 47.4 (16.4) years. Among participants who self-reported abstinence at 6 months, 50.3% (85 of 169) had biochemical validation by both an exhaled carbon monoxide test and a saliva cotinine test. Compared with the control group, the intervention group had statistically higher biochemically validated abstinence at 6 months: 6.7% (53 of 787) vs 2.8% (22 of 784) (P < .001), with an adjusted relative risk of 3.21 (95% CI, 1.74-5.93; P < .001). The intervention group also had higher self-reported quit rates at 6 months (12.2% [96 of 787] vs 9.3% [73 of 784], P = .04) and 12 months (13.0% [102 of 787] vs 8.5% [67 of 784], P < .01), as well as higher biochemically validated abstinence at 12 months (7.0% [55 of 787] vs 3.7% [29 of 784], P < .001). The additional cost for each intervention group participant was US $0.47, with an estimated gain of 0.0238 quality-adjusted life-year. The incremental cost per quality-adjusted life-year (US $19.53) fell within acceptable thresholds.
Conclusions and Relevance


This brief, low-cost self-determination theory-based intervention for smokers presenting at EDs effectively increased the biochemically validated quit rate at 6 months. If delivered routinely, such a simple intervention may offer a cost-effective and sustainable approach to help many smokers quit smoking.
Trial Registration


ClinicalTrials.gov identifier: NCT02660957.",2020,"Compared with the control group, the intervention group had statistically higher biochemically validated abstinence at 6 months: 6.7% (53 of 787) vs 2.8% (22 of 784) (P < .001), with an adjusted relative risk of 3.21 (95% CI, 1.74-5.93; P < .001).","['4 major acute care hospitals in different districts of Hong Kong', 'Smokers at Emergency Departments in Hong Kong', '1571 smokers 18 years or older who presented at 4 major EDs between July 4, 2015, and March 17, 2017', 'Results\n\n\nParticipants (N\u2009=\u20091571) included 1381 men (87.9%); the mean (SD) age at baseline was 47.4 (16.4) years', 'Chinese smokers presenting at EDs in Hong Kong']","['brief advice (about 1 minute) and could choose their own quit schedules (immediate or progressive', 'brief intervention based on self-determination theory for smoking cessation (immediate or progressive', 'smoking cessation leaflet', 'Brief Self-determination Theory-Based Smoking Cessation Intervention']","['validated abstinence', 'higher self-reported quit rates', 'exhaled carbon monoxide test and a saliva cotinine test']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}]",1381.0,0.0958918,"Compared with the control group, the intervention group had statistically higher biochemically validated abstinence at 6 months: 6.7% (53 of 787) vs 2.8% (22 of 784) (P < .001), with an adjusted relative risk of 3.21 (95% CI, 1.74-5.93; P < .001).","[{'ForeName': 'William Ho Cheung', 'Initials': 'WHC', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ka Yan', 'Initials': 'KY', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Derek Yee Tak', 'Initials': 'DYT', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Katherine Ka Wai', 'Initials': 'KKW', 'LastName': 'Lam', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kai Yeung', 'Initials': 'KY', 'LastName': 'Cheung', 'Affiliation': 'United Christian Hospital, Hospital Authority, Hong Kong, China.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sophia Siu Chee', 'Initials': 'SSC', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5176']
647,31771601,A Phase I/II trial comparing autologous dendritic cell vaccine pulsed either with personalized peptides (PEP-DC) or with tumor lysate (OC-DC) in patients with advanced high-grade ovarian serous carcinoma.,"BACKGROUND


Most ovarian cancer patients are diagnosed at a late stage with 85% of them relapsing after surgery and standard chemotherapy; for this reason, new treatments are urgently needed. Ovarian cancer has become a candidate for immunotherapy by reason of their expression of shared tumor-associated antigens (TAAs) and private mutated neoantigens (NeoAgs) and the recognition of the tumor by the immune system. Additionally, the presence of intraepithelial tumor infiltrating lymphocytes (TILs) is associated with improved progression-free and overall survival of patients with ovarian cancer. The aim of active immunotherapy, including vaccination, is to generate a new anti-tumor response and amplify an existing immune response. Recently developed NeoAgs-based cancer vaccines have the advantage of being more tumor specific, reducing the potential for immunological tolerance, and inducing robust immunogenicity.
METHODS


We propose a randomized phase I/II study in patients with advanced ovarian cancer to compare the immunogenicity and to assess safety and feasibility of two personalized DC vaccines. After standard of care surgery and chemotherapy, patients will receive either a novel vaccine consisting of autologous DCs pulsed with up to ten peptides (PEP-DC), selected using an agnostic, yet personalized, epitope discovery algorithm, or a sequential combination of a DC vaccine loaded with autologous oxidized tumor lysate (OC-DC) prior to an equivalent PEP-DC vaccine. All vaccines will be administered in combination with low-dose cyclophosphamide. This study is the first attempt to compare the two approaches and to use NeoAgs-based vaccines in ovarian cancer in the adjuvant setting.
DISCUSSION


The proposed treatment takes advantage of the beneficial effects of pre-treatment with OC-DC prior to PEP-DC vaccination, prompting immune response induction against a wide range of patient-specific antigens, and amplification of pre-existing NeoAgs-specific T cell clones. Trial registration This trial is already approved by Swissmedic (Ref.: 2019TpP1004) and will be registered at http://www.clinicaltrials.gov before enrollment opens.",2019,Ovarian cancer has become a candidate for immunotherapy by reason of their expression of shared tumor-associated antigens (TAAs) and private mutated neoantigens (NeoAgs) and the recognition of the tumor by the immune system.,"['patients with ovarian cancer', 'patients with advanced high-grade ovarian serous carcinoma', 'ovarian cancer patients', 'patients with advanced ovarian cancer']","['cyclophosphamide', 'personalized DC vaccines', 'autologous dendritic cell vaccine pulsed either with personalized peptides (PEP-DC) or with tumor lysate (OC-DC', 'novel vaccine consisting of autologous DCs pulsed with up to ten peptides (PEP-DC', 'standard chemotherapy', 'DC vaccine loaded with autologous oxidized tumor lysate (OC-DC) prior to an equivalent PEP-DC vaccine']",['progression-free and overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0206701', 'cui_str': 'Cystadenocarcinoma, Serous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0913765,Ovarian cancer has become a candidate for immunotherapy by reason of their expression of shared tumor-associated antigens (TAAs) and private mutated neoantigens (NeoAgs) and the recognition of the tumor by the immune system.,"[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Sarivalasis', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Boudousquié', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Balint', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Stevenson', 'Affiliation': 'Swiss Institute of Bioinformatics, 1015, Lausanne, Switzerland.'}, {'ForeName': 'Philippe O', 'Initials': 'PO', 'LastName': 'Gannon', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Emanuela Marina', 'Initials': 'EM', 'LastName': 'Iancu', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Rossier', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Martin Lluesma', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'Women-Mother-Child Department, Service of Gynecology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sempoux', 'Affiliation': 'Department of Pathology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Coukos', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'Laboratory of Biostatistics, School of Health Sciences, National and Kapodistrian, University of Athens, Athens, Greece.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Harari', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bassani-Sternberg', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Lana E', 'Initials': 'LE', 'LastName': 'Kandalaft', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland. Lana.Kandalaft@chuv.ch.'}]",Journal of translational medicine,['10.1186/s12967-019-02133-w']
648,31771074,Effect of environmental music on autonomic function in infants in intensive and growing care units.,"BACKGROUND


The aim of this study is (1) to observe the effect of the background music (BGM) in the incubator on heart rate variability (HRV) during the first few weeks of life in preterm infants in the neonatal intensive (NICU) and growing care units (GCU) and (2) to investigate the effect of environmental music on autonomic function in the infants.
METHODS


Thirty infants, including premature (26 3/7 - 38 4/7 weeks) and low-birth weight (LBW) (946-2,440 g) infants, admitted to the NICU or GCU were involved. The heart rate, low- (LF, 0.05-0.15 Hz) and high- (HF, 0.15-0.4 Hz) frequency HRV components, and LF/HF ratio were measured. The BGM, lullabies for a baby, was delivered through a speaker in the incubator, and the HRV components were compared among before, during, and after intervention with BGM.
RESULTS


The mean HR did not change among the experimental conditions. The LF and HF values decreased during the BGM condition, but not LF/HF, compared with the condition before BGM.
CONCLUSIONS


The present results showed that an auditory environment affected the autonomic function of infants with a range of BGM in the NICU/GCU. The present study also suggested that BGM, a non-invasive and non-pharmacological intervention, could be an evaluation tool for autonomic function in infants in NICU/GCU.",2020,"The LF and HF values decreased during the BGM condition, but not LF/HF, compared with the condition before BGM.
","['Thirty infants, including premature (26 3/7 - 38 4/7 weeks) and low-birth weight (LBW) (946-2,440\u200ag) infants, admitted to the NICU or GCU were involved', 'preterm infants in the neonatal intensive (NICU) and growing care units (GCU) and (2', 'infants', 'infants in intensive and growing care units']","['environmental music', 'background music (BGM']","['LF and HF values', 'autonomic function', 'heart rate variability (HRV', 'HRV components, and LF/HF ratio', 'mean HR', 'heart rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0625173,"The LF and HF values decreased during the BGM condition, but not LF/HF, compared with the condition before BGM.
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Rehabilitation Sciences, Graduate School of Health Sciences, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hoshiyama', 'Affiliation': 'Brain and Mind Research Center, Nagoya University, Higashi-ku, Nagoya, Japan.'}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-180174']
649,31771081,Prolonged intravenous immunoglobulin treatment in very low birth weight infants with late onset sepsis.,"BACKGROUND


Neonatal infections are a leading cause of morbi-mortality despite advances in antimicrobials and neonatal care. Preterm infants have greater susceptibility to sepsis due to an immature immune system and lower immunoglobulin levels. Intravenous immunoglobulins (IVIG) have been used in several studies as an adjuvant treatment to improve this physiological immune deficiency, with different outcomes.
METHODS


Very low birth weight (VLBW) infants who developed sepsis in the neonatal ICU were studied. They were randomly divided in 2 groups: one group was treated with antibiotics (Group I), and the other received antibiotics plus a 500 mg/kg/day of IVIG during 7 days (Group II). Serum IgG concentration was determined at initiation, during and after treatment Group I, and daily during the 7 days of therapy in Group II.
RESULTS


The baseline IgG concentration in group II was 486 g/dL, and increased to 852 mg/dL after the first dose of IVIG (p < 0.01). After the seventh day of infusion a mean IgG level of 1898 mg/dL was achieved. A direct correlation (r = 0.94) between IgG concentration and days of treatment was observed. Blood cultures were positive in 70% of the infants in group I and 75.5% in group II. Staphylococcus epidermidis was the most frequent isolated bacteria in blood cultures. The lethality rate was 25.0% in group I and 5.0% in Group II (p < 0.03). We did not observe collateral effects with the administration of IVIG.
CONCLUSIONS


Prolonged therapy with IVIG seems to be safe and effective as an adjuvant treatment in VLBW infants with sepsis.",2020,The lethality rate was 25.0% in group I and 5.0% in Group II (p < 0.03).,"['Preterm infants', 'VLBW infants with sepsis', 'very low birth weight infants with late onset sepsis', 'Very low birth weight (VLBW) infants who developed sepsis in the neonatal ICU were studied']","['immunoglobulin', 'antibiotics plus a 500\u200amg/kg/dav of IVIG', 'antibiotics', 'Intravenous immunoglobulins (IVIG']","['Serum IgG concentration', 'baseline IgG concentration', 'lethality rate', 'Blood cultures']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}]",,0.0537328,The lethality rate was 25.0% in group I and 5.0% in Group II (p < 0.03).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bancalari', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Concepcion, Concepción, Biobio, Chile.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Muñoz', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, University of Concepcion, Concepción, Biobio, Chile.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martínez', 'Affiliation': 'Department of Neonatology, Clínica Sanatorio Alemán, Concepción, Biobio, Chile.'}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-190259']
650,32410424,[Evaluation of multimodal analgesia in treatment of avascular necrosis of femoral head with free vascularized fibular grafting].,"Objective


To prospective study the effectiveness and safety of multimodal analgesia (MA) in treatment of avascular necrosis of the femoral head with free vascularized fibular grafting (FVFG).
Methods


Sixty patients with avascular necrosis of the femoral head, who were scheduled to unilateral primary FVFG between February 2016 and December 2016 and met the selection criteria, were included in the study. All patients were allocated to two groups according to the method of random number table: MA group (  n =30) and control group (  n =30). There was no significant difference in gender, age, body mass index, side, duration and stage of avascular necrosis of the femoral head, preoperative visual analogue scale (VAS) scores under quiescent and active states, and range of motion (ROM) of hip flexion and abduction before operation (  P >0.05). The patients in the MA group were treated with MA therapy, including oral administration of celecoxib before operation, local anesthetic wound infiltration during operation, and ice compression and oral administration of celecoxib after operation. The patients in control group were only treated with patient-controlled intravenous analgesia pump. The postoperative VAS scores under quiescent and active states, ROM of hip flexion and abduction, prescription of Tramadol and adverse reaction were recorded and compared.
Results


The operations were completed successfully in both groups without obvious complications and adverse reaction. The Tramadol was used in 4 cases (13.3%) of MA group and in 11 cases (36.7%) of control group, but no significant difference was found between the two groups (  χ   2 =4.356,  P =0.072). The VAS scores under quiescent state at 6 and 24 hours postoperatively were significantly lower in MA group than in control group (  P <0.05), while VAS scores under active state at 48 hours postoperatively and on the day of discharge were significantly lower in MA group than in control group (  P <0.05). There was no significant difference in VAS score between two groups at other time points (  P >0.05). The ROM of hip flexion in MA group was better than that in control group at 1 day postoperatively and the day of discharge (  P <0.05), while no significant difference was found at 2 and 3 days postoperatively (  P >0.05). The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
Conclusion


The MA can effectively relieve the pain following FVFG and facilitate early functional exercises of the hip. The usage of opioids was also relatively fewer for MA protocol.",2020,"The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
","['avascular necrosis of femoral head with free vascularized fibular grafting', 'Sixty patients with avascular necrosis of the femoral head, who were scheduled to unilateral primary FVFG between February 2016 and December 2016 and met the selection criteria, were included in the study', 'avascular necrosis of the femoral head with free vascularized fibular grafting (FVFG']","['patient-controlled intravenous analgesia pump', 'multimodal analgesia (MA', 'Tramadol', 'celecoxib', 'MA therapy', 'multimodal analgesia']","['VAS score', 'postoperative VAS scores under quiescent and active states, ROM of hip flexion and abduction, prescription of Tramadol and adverse reaction', 'gender, age, body mass index, side, duration and stage of avascular necrosis of the femoral head, preoperative visual analogue scale (VAS) scores under quiescent and active states, and range of motion (ROM) of hip flexion and abduction before operation', 'VAS scores under quiescent state', 'ROM of hip abduction', 'VAS scores under active state', 'ROM of hip flexion']","[{'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042382', 'cui_str': 'Vascularized'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",60.0,0.0218635,"The ROM of hip abduction in MA group was superior to the control group at 1, 2, and 3 days postoperatively and the day of discharge (  P <0.05).
","[{'ForeName': 'Difei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Sanlian', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201907023']
651,31216875,A Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men: Results From the  Animo  Pilot Randomized Controlled Trial.,"Background . Hispanic males have the highest rates of overweight and obesity compared with men of all other racial/ethnic groups. While weight loss can significantly reduce obesity-related health risks, there is limited research examining effective gender- and culturally tailored behavioral weight loss programs for Hispanic men.  Objective . To assess the feasibility and preliminary efficacy of a 12-week gender- and culturally sensitive weight loss intervention (GCSWLI) as compared with a waist-list control (WLC) in sedentary, Hispanic males with overweight/obesity.  Method . Fifty Hispanic males (age: 43 years [ SD  = 11]; BMI: 34 ± 5 kg/m 2 ; 58% Spanish monolingual) were randomized to one of two groups: GCSWLI ( n  = 25) or WLC ( n  = 25). GCSWLI participants attended weekly in-person individual sessions with a bilingual, bicultural Hispanic male lifestyle coach, and were prescribed a daily reduced calorie goal and 225 minutes of moderate-intensity physical activity per week. The WLC were asked to maintain their usual diet and physical activity habits for 12 weeks. GCSWLI participants continued with 12 additional weeks of follow-up including biweekly phone calls with lifestyle coaches.  Results . At Week 12, the mean weight loss in the GCSWLI was -6.3 kg (95% confidence interval [CI; -8.1, -4.4]) compared with -0.8 kg (95% CI [-2.5, 0.9]) for the WLC (difference = -5.5 kg, 95% CI [-8.0, -2.9],  p  < .01). At Week 24, weight loss in the GCSWLI was maintained.  Conclusions . The GCSWLI appears to be a feasible strategy to engage Hispanic males in short-term weight loss. Our pilot study indicates preliminary evidence of efficacy, though confirmation of these findings is needed in a larger study.",2019,GCSWLI participants continued with 12 additional weeks of follow-up including biweekly phone calls with lifestyle coaches.  ,"['Hispanic men', 'Hispanic males', 'Fifty Hispanic males (age: 43 years [ SD  = 11]; BMI: 34 ± 5 kg/m 2 ; 58% Spanish monolingual', 'sedentary, Hispanic males with overweight/obesity', 'Hispanic Men']","['waist-list control (WLC', '12-week gender- and culturally sensitive weight loss intervention (GCSWLI', 'WLC', 'Gender- and Culturally Sensitive Weight Loss Intervention']","['weight loss', 'mean weight loss']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",50.0,0.0505138,GCSWLI participants continued with 12 additional weeks of follow-up including biweekly phone calls with lifestyle coaches.  ,"[{'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Garcia', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Valdez', 'Affiliation': 'University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Aceves', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Bell', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Humphrey', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Hingle', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Marylyn', 'Initials': 'M', 'LastName': 'McEwen', 'Affiliation': 'University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Hooker', 'Affiliation': 'San Diego State University, San Diego, CA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119853011']
652,31204610,Vicarious Experience to Affect Physical Activity in Women: A Randomized Control Trial.,"People compare themselves to others for self-evaluation, practical information, and motivation for healthy behaviors. The effect of active peer models on comparative thinking is unknown. The purpose of this 12-week, randomized, two-group pilot study was to evaluate the effect of a workplace peer modeling intervention on self-efficacy, motivation, and comparative thinking. The attention control group (ACG;  n  = 24) received general health information. The intervention group ( n  = 26) met with active peer models, received an exercise prescription and information. No significant group by time interaction effects were found. Comparisons on ability (how well am I doing), opinions (what should I think or believe), future self (think about my future), and modeling (be like someone else) all increased in the intervention group ( n  = 21) but decreased in the ACG ( n  = 22). Active peer models may support physical activity behavior change through specific lines of comparative thinking.",2020,No significant group by time interaction effects were found.,['Working Women'],"['general health information', 'exercise prescription and information', 'workplace peer modeling intervention']","['self-efficacy, motivation, and comparative thinking', 'time interaction effects']","[{'cui': 'C0043215', 'cui_str': 'Women, Working'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0375231,No significant group by time interaction effects were found.,"[{'ForeName': 'Sheri A', 'Initials': 'SA', 'LastName': 'Rowland', 'Affiliation': 'University of Nebraska Medical Center, Lincoln, USA.'}, {'ForeName': 'Marlene Z', 'Initials': 'MZ', 'LastName': 'Cohen', 'Affiliation': 'University of Nebraska Medical Center, Omaha, USA.'}, {'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Pullen', 'Affiliation': 'University of Nebraska Medical Center, Omaha, USA.'}, {'ForeName': 'Paula S', 'Initials': 'PS', 'LastName': 'Schulz', 'Affiliation': 'University of Nebraska Medical Center, Lincoln, USA.'}, {'ForeName': 'Kris E', 'Initials': 'KE', 'LastName': 'Berg', 'Affiliation': 'University of Nebraska-Omaha, USA.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': 'University of Nebraska Medical Center, Omaha, USA.'}, {'ForeName': 'Bunny J', 'Initials': 'BJ', 'LastName': 'Pozehl', 'Affiliation': 'University of Nebraska Medical Center, Omaha, USA.'}, {'ForeName': 'Bernice C', 'Initials': 'BC', 'LastName': 'Yates', 'Affiliation': 'University of Nebraska Medical Center, Omaha, USA.'}]",Western journal of nursing research,['10.1177/0193945919856575']
653,31200629,Dynamic scapular recognition exercise improves scapular upward rotation and shoulder pain and disability in patients with adhesive capsulitis: a randomized controlled trial.,"BACKGROUND


Examine the ability of a dynamic scapular recognition exercise to improve scapular upward rotation and decrease shoulder pain and disability in patients with adhesive capsulitis of the shoulder.
METHODS


A test-retest randomized controlled study design was used. A total of sixty-six patients with unilateral adhesive capsulitis were equally divided into two groups. The study group received a dynamic scapular recognition exercise using a wireless biofeedback system, while the control group received placebo treatment in the form of active range-of-motion (ROM) exercises of the sound upper limb. A digital inclinometer was used to measure the scapular upward rotation and ROM of the shoulder joint, and the Shoulder Pain and Disability Index (SPADI) was used to measure the shoulder pain and disability.
RESULTS


Study results showed that after two weeks, there were statistically significant differences between the study and control groups in scapular upward rotation and shoulder flexion and abduction (P < .05) and nonsignificant differences in shoulder external rotation and SPADI (P > .05). After two and six months, there were statistically significant differences between study and control groups in scapular upward rotation; shoulder flexion, abduction and external rotation; and SPADI scores (P < .05).
CONCLUSION


This study showed that a dynamic scapular recognition exercise significantly improves scapular upward rotation and the ROM of shoulder flexion and abduction after two weeks. At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores. These improvements persisted for six months after the performance of this exercise.",2020,"At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores.","['A total of sixty-six patients with unilateral adhesive capsulitis', 'patients with adhesive capsulitis', 'patients with adhesive capsulitis of the shoulder']","['Dynamic scapular recognition exercise', 'dynamic scapular recognition exercise', 'dynamic scapular recognition exercise using\xa0a\xa0wireless biofeedback system, while the control group received placebo treatment in the form of active range-of-motion (ROM) exercises of the sound upper limb']","['shoulder pain and disability', 'scapular upward rotation and shoulder flexion and abduction', 'shoulder external rotation and SPADI', 'scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores', 'scapular upward rotation and ROM of the shoulder joint,\xa0and the Shoulder Pain and Disability Index (SPADI', 'scapular upward rotation and the ROM of shoulder flexion and abduction', 'scapular upward rotation; shoulder flexion, abduction and external rotation; and SPADI scores', 'scapular upward rotation and shoulder pain and disability']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0158300', 'cui_str': 'Adhesive Capsulitis'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0179310', 'cui_str': 'Biofeedback system'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise (regime/therapy)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037009', 'cui_str': 'Glenohumeral Joint'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",66.0,0.0736383,"At two and six months, this exercise improves scapular upward rotation; ROM of shoulder flexion, abduction, and external rotation; and SPADI scores.","[{'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign , Champaign, IL, USA.'}, {'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign , Champaign, IL, USA.'}, {'ForeName': 'Wadida H', 'Initials': 'WH', 'LastName': 'El Sayed', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University , Giza Egypt.'}, {'ForeName': 'Mohamed E Abdel', 'Initials': 'MEA', 'LastName': 'Wanis', 'Affiliation': 'Department of Orthopedic, Faculty of Medicine, Suhag University , Sohag, Egypt.'}, {'ForeName': 'Abeer A', 'Initials': 'AA', 'LastName': 'Yamany', 'Affiliation': 'Department of Basic Science, Faculty of Physical Therapy, Cairo University , Giza Egypt.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1622896']
654,31655410,Safety and pharmacodynamics of a novel recombinant botulinum toxin E (rBoNT-E): Results of a phase 1 study in healthy male subjects compared with abobotulinumtoxinA (Dysport®).,"Naturally occurring botulinum toxin (BoNT) serotypes have different pharmacological features of therapeutic and aesthetic interest. This phase 1, double-blind, placebo-controlled study (EudraCT: 2016-002609-20) assessed safety, tolerability and pharmacodynamics (PD) of the first recombinant BoNT serotype E (rBoNT-E) versus abobotulinumtoxinA (Dysport®), administered to extensor digitorum brevis (EDB) of healthy males. Subjects were randomised 3:1 (n = 28) to single ascending rBoNT-E (0.04-3.6 ng) doses or placebo. A further 24 subjects received abobotulinumtoxinA (20, 40, or 70 U) or placebo. PD were assessed using compound muscle action potential (CMAP) amplitude. Demographics were similar between groups. All rBoNT-E doses were well tolerated (no severe treatment-emergent adverse events [TEAEs], serious adverse events, or treatment-related toxicities). Most TEAEs were mild/moderate and treatment-unrelated. rBoNT-E had a faster onset of action (days 1-2 post-injection), greater peak effect (>90% CMAP inhibition), and shorter duration of effect at highest tested doses versus abobotulinumtoxinA (onset of action ≤7 days post-injection; 70% maximal CMAP inhibition). rBoNT-E duration of effect was 2-7 weeks versus >26 weeks for abobotulinumtoxinA. Dose-dependent effects were observed for magnitude and duration of EDB CMAP inhibition, plateauing at 0.9 and 3.6 ng. rBoNT-E demonstrated a good safety profile and a PD profile that may address unmet therapeutic and aesthetic patient needs.",2019,"rBoNT-E had a faster onset of action (days 1-2 post-injection), greater peak effect (>90% CMAP inhibition), and shorter duration of effect at highest tested doses versus abobotulinumtoxinA (onset of action","['healthy males', 'healthy male subjects']","['novel recombinant botulinum toxin E (rBoNT-E', 'botulinum toxin (BoNT) serotypes', 'abobotulinumtoxinA', 'abobotulinumtoxinA (Dysport®', 'placebo', 'rBoNT', 'recombinant BoNT serotype E (rBoNT-E) versus abobotulinumtoxinA (Dysport®']","['rBoNT-E duration of effect', 'magnitude and duration of EDB CMAP inhibition', 'safety, tolerability and pharmacodynamics (PD', 'serious adverse events, or treatment-related toxicities']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0006054', 'cui_str': 'botulinum neurotoxin type E'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C0591427', 'cui_str': 'Dysport'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.27917,"rBoNT-E had a faster onset of action (days 1-2 post-injection), greater peak effect (>90% CMAP inhibition), and shorter duration of effect at highest tested doses versus abobotulinumtoxinA (onset of action","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pons', 'Affiliation': 'Ipsen Innovation, Les Ulis, France. Electronic address: laurent.pons@ipsen.com.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vilain', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Volteau', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2019.116516']
655,31174239,Increased local failure for patients with intermediate-risk rhabdomyosarcoma on ARST0531: A report from the Children's Oncology Group.,"BACKGROUND


The objective of this study was to evaluate local control for patients with intermediate-risk rhabdomyosarcoma (RMS) treated on Children's Oncology Group (COG) protocol ARST0531.
METHODS


This study analyzed 424 patients with intermediate-risk RMS. Patients were randomized to chemotherapy with either vincristine, dactinomycin, and cyclophosphamide (VAC) or VAC alternating with vincristine and irinotecan. With the goal of improving local control, radiation therapy (RT) was delivered early at week 4 and was concurrent with irinotecan in the experimental arm. Individualized local control plans for children 24 months old or younger were allowed. Local failure on ARST0531 was compared with local failure on the preceding COG intermediate-risk study, D9803.
RESULTS


For patients with group I/II alveolar RMS (n = 55), the 5-year cumulative incidence of local failure was 13.4%; for group III alveolar RMS (n = 141), it was 20.2%; and for group III embryonal RMS (n = 228), it was 27.9% (P = .03). Among patients with group III disease, local failure did not differ by histology, site, nodal status, RT modality, or treatment arm. Local failure was worse for a tumor size >5 cm (32.3% vs 16.7%; P = .001). Among patients with group III embryonal RMS, local failure was higher on ARST0531 than D9803 (27.9% vs 19.4%; P = .03). After the exclusion of patients 24 months old or younger or patients who did not receive radiation, local failure remained significantly increased on ARST0531 (P = .02). After adjustments for clinical prognostic factors, event-free survival and overall survival were worse on ARST0531 (P = .004 and P = .05, respectively).
CONCLUSIONS


Despite interventions designed to enhance local control, local control was inferior on ARST0531 in comparison with D9803. The reason for this is unclear, but it could be the reduced cyclophosphamide dose on ARST0531.",2019,"Despite interventions designed to enhance local control, local control was inferior on ARST0531 in comparison with D9803.","[""patients with intermediate-risk rhabdomyosarcoma (RMS) treated on Children's Oncology Group (COG) protocol ARST0531"", 'children 24\xa0months old or younger were allowed', 'patients with intermediate-risk rhabdomyosarcoma', '424 patients with intermediate-risk RMS']","['vincristine, dactinomycin, and cyclophosphamide (VAC) or VAC alternating with vincristine and irinotecan', 'radiation therapy (RT', 'Individualized local control plans']","['local failure', 'Local failure', 'clinical prognostic factors, event-free survival and overall survival', '5-year cumulative incidence of local failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035412', 'cui_str': 'Rhabdomyosarcoma'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",424.0,0.0297607,"Despite interventions designed to enhance local control, local control was inferior on ARST0531 in comparison with D9803.","[{'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Casey', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Donaldson', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Seattle Children's Hospital, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'University of Florida, Gainesville, Florida.'}, {'ForeName': 'Carola A', 'Initials': 'CA', 'LastName': 'Arndt', 'Affiliation': 'Mayo Clinic and Foundation, Rochester, Minnesota.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rodeberg', 'Affiliation': 'East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Routh', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Lautz', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Abha A', 'Initials': 'AA', 'LastName': 'Gupta', 'Affiliation': 'Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Torunn I', 'Initials': 'TI', 'LastName': 'Yock', 'Affiliation': 'Massachussets General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Wolden', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Cancer,['10.1002/cncr.32204']
656,31170542,Comparing Direct Challenge to Penicillin Skin Testing for the Outpatient Evaluation of Penicillin Allergy: A Randomized Controlled Trial.,"BACKGROUND


Direct challenge (DC) may be a safe and effective alternative to penicillin skin testing (PST) in low-risk patients.
OBJECTIVE


To complete a prospective, randomized, controlled trial comparing PST followed by a challenge to amoxicillin versus a 2-step DC to amoxicillin without preceding skin testing in a predefined low-risk patient population.
METHODS


Penicillin allergy histories were reviewed in patients presenting to an outpatient allergy/immunology practice from April 2018 to August 2018. Patients 5 years or older with a cutaneous-only or unknown reaction (>1 year ago for those aged 5-17 years, >10 years ago for those 18 years or older) were randomized 1:1 to PST or 2-step DC. All children younger than 5 years underwent DC, and patients with extracutaneous reaction histories underwent PST. All groups were monitored 30 minutes after administration of amoxicillin.
RESULTS


Penicillin allergy was reported in 363 of 2465 (14.7%) patients, of which 185 consented to further evaluation. Thirteen patients younger than 5 years underwent DC; all were negative. Thirteen patients with angioedema and/or extracutaneous symptoms underwent PST; 2 of 13 patients had positive PST result. A total of 159 patients were randomized to DC (49.7%) or PST (50.3%). PST result was negative in 70 of 80 (87.5%) patients. All 70 patients had a negative amoxicillin challenge. DC was negative in 76 of 79 (96.2%) patients; positive DC reactions were minor. Average time for patients undergoing PST was 72.7 ± 5.3 minutes and for patients undergoing DC was 66.7 ± 4.8 minutes.
CONCLUSIONS


In low-risk patients, DC provided a safe and effective alternative to PST in delabeling penicillin allergy. Compared with PST, DC may also take less time, cost less money, and lead to fewer penicillin allergy evaluations with false-positive results.",2019,"Compared with PST, DC may also take less time, cost less money, and lead to fewer penicillin allergy evaluations with false-positive results.","['Thirteen patients with angioedema and/or extracutaneous symptoms underwent PST; 2 of 13 patients had positive PST result', '159 patients', 'a predefined low-risk patient population', 'All children younger than 5 years underwent DC, and patients with extracutaneous reaction histories underwent PST', 'All 70 patients had a negative amoxicillin challenge', 'Thirteen patients younger than 5 years underwent', 'low-risk patients', 'Penicillin allergy histories were reviewed in patients presenting to an outpatient allergy/immunology practice from April 2018 to August 2018', 'Patients 5 years or older with a cutaneous-only or unknown reaction (>1 year ago for those aged 5-17 years, >10 years ago for those 18 years or older']","['Penicillin Skin Testing', 'amoxicillin', 'penicillin skin testing (PST', 'PST', 'PST or 2-step DC', 'DC']","['Average time', 'positive DC reactions']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869027', 'cui_str': 'Angioedema (SMQ)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0030824', 'cui_str': 'Allergy to penicillin (disorder)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",159.0,0.0506061,"Compared with PST, DC may also take less time, cost less money, and lead to fewer penicillin allergy evaluations with false-positive results.","[{'ForeName': 'S Shahzad', 'Initials': 'SS', 'LastName': 'Mustafa', 'Affiliation': 'Rochester Regional Health, Rochester, NY; University of Rochester School of Medicine and Dentistry, Rochester, NY. Electronic address: shahzad.mustafa@rochesterregional.org.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Conn', 'Affiliation': 'Wegmans School of Pharmacy, St John Fisher College, Rochester, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ramsey', 'Affiliation': 'Rochester Regional Health, Rochester, NY; University of Rochester School of Medicine and Dentistry, Rochester, NY. Electronic address: allison.ramsey@rochesterregional.org.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.05.037']
657,31221354,Atrial Remodeling Following Catheter Ablation for Atrial Fibrillation-Mediated Cardiomyopathy: Long-Term Follow-Up of CAMERA-MRI Study.,"OBJECTIVES


This study sought to determine the long-term right atrial (RA) electrical and structural changes in a subgroup from the CAMERA-MRI (Catheter Ablation Versus Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction-Magnetic Resonance Imaging) study.
BACKGROUND


Catheter ablation (CA) is successful in restoring ventricular function in patients with atrial fibrillation (AF) and otherwise unexplained cardiomyopathy, as demonstrated in the randomized study of CA versus rate control (CAMERA-MRI). It is unknown if this is associated with atrial remodeling.
METHODS


Detailed electroanatomical (EA) mapping of the RA using CARTO3 and a force sensing catheter was performed at initial CA and electively at least 12 months after CA in patients with >90% reduction in AF burden following ablation. Bipolar voltage, fractionation, and conduction velocity were collected in 4 segments together with echo and cardiac magnetic resonance imaging.
RESULTS


Fifteen patients (mean age 59.1 ± 6.8 years) underwent repeat RA EA mapping. At a mean follow-up of 23.4 ± 11.9 months, left ventricular (LV) ejection fraction improved from 33.6 ± 3.2% to 54.1 ± 3.2% (p = 0.001), RA area decreased from 28.4 ± 2.0 cm 2  to 20.8 ± 1.2 cm 2  (p < 0.001), and left atrial area decreased from 32.9 ± 2.3 cm 2  to 26.8 ± 1.4 cm 2  (p = 0.007). On EA mapping, RA bipolar voltage increased from 1.6 ± 0.1 mV to 1.9 ± 0.1 mV (p = 0.04). Tissue voltage increased across all regions, which achieved statistical significance at the posterior (p = 0.002) and septal (p = 0.01) segments. There was a significant decrease in complex fractionated electrograms from 21.7 ± 3.5% to 8.3 ± 1.8% (p = 0.002); however, no significant change occurred in global or regional conduction velocities (p = 0.5).
CONCLUSIONS


Recovery of atrial electrical and structural changes was observed following restoration of sinus rhythm and recovery of LV function in patients who underwent CA for persistent AF and LV systolic dysfunction. The randomized CAMERA MRI study demonstrated significant improvement in LV systolic function with AF ablation compared with rate control. The present study demonstrated reverse electrical and structural atrial recovery in concert with recovery of LV systolic function at 2 years post-AF ablation. This may partially explain the long-term success of CA in patients with AF and otherwise unexplained cardiomyopathy.",2019,"Tissue voltage increased across all regions, which achieved statistical significance at the posterior (p = 0.002) and septal (p = 0.01) segments.","['Fifteen patients (mean age 59.1 ± 6.8 years) underwent repeat RA EA mapping', 'patients with atrial fibrillation (AF) and otherwise unexplained cardiomyopathy', 'Cardiomyopathy', 'patients with AF and otherwise unexplained cardiomyopathy']","['Catheter Ablation', 'CAMERA-MRI (Catheter Ablation Versus Medical Rate Control', 'AF ablation', 'Catheter ablation (CA']","['Tissue voltage', 'left ventricular (LV) ejection fraction', 'left atrial area', 'RA bipolar voltage', 'LV systolic function', 'complex fractionated electrograms', 'Bipolar voltage, fractionation, and conduction velocity', 'RA area', 'global or regional conduction velocities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}]","[{'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.0320368,"Tissue voltage increased across all regions, which achieved statistical significance at the posterior (p = 0.002) and septal (p = 0.01) segments.","[{'ForeName': 'Hariharan', 'Initials': 'H', 'LastName': 'Sugumar', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Prabhu', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Voskoboinik', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Gutman', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoffrey R', 'Initials': 'GR', 'LastName': 'Wong', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Parameswaran', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chrishan J', 'Initials': 'CJ', 'LastName': 'Nalliah', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'McLellan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Taylor', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Liang-Han', 'Initials': 'LH', 'LastName': 'Ling', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Kalman', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kistler', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia; The Alfred Hospital, Melbourne, Victoria, Australia; University of Melbourne, Melbourne, Victoria, Australia. Electronic address: peter.kistler@baker.edu.au.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2019.03.009']
658,32410425,[Effect of different use time of intermittent pneumatic compression on the incidence of deep vein thrombosis of lower extremities after arthroplasty].,"Objective


To investigate the effect of different use time of intermittent pneumatic compression (IPC) on the incidence of deep vein thrombosis (DVT) of lower extremities after arthroplasty.
Methods


Between October 2018 and February 2019, 94 patients who planned to undergo unilateral total hip or knee arthroplsty and met the selection criteria were randomly divided into a control group (47 cases) and a trial group (47 cases). There was no significant difference in gender, age, surgical site, and surgical reason between the two groups (  P >0.05). After returning to the ward, all patients were treated with IPC. And the IPC was used until 9:00 pm on the day after operation in the trial group and until 8:00 am the next day after operation in the control group. The levels of hemoglobin, platelet count, D-dimer, hospital stay, treatment costs, patients' satisfaction with IPC, the parameters of thromboelastrography [kinetics (K value), freezing angle (α angle), reaction time (R value), maximum amplitude (MA value)], visual analogue scale (VAS) score, circumference difference of calf before and after operation, Pittsburgh sleep assessment score, and the incidence of DVT of lower limbs were recorded and compared between the two groups.
Results


The K value and D-dimer before operation were significant different between the two groups (  P <0.05). There was no significant difference in pre- and post-operative hemoglobin, platelet count, and the other parameters of thromboelastography between the two groups (  P >0.05). There was no significant difference in pre- and post-operative VAS scores and post-operative circumference difference of calf between the two groups (  P >0.05). The sleep assessment score of the trial group at 1 day after operation was significant lower than that of the control group (  t =2.107,  P =0.038). There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05). There was 1 case (2.1%) of DVT, 3 cases (6.4%) of intermuscular venous thrombosis, and 1 case (2.1%) of infection in the trial group, and 2 cases (4.3%), 4 cases (8.5%), and 0 (0) in the control group. The differences were not significant (  P >0.05). After the completion of postoperative IPC treatment, the satisfaction rates of using IPC were 89.4%(42/47) in the trial group and 70.2% (33/47) in the control group, and the difference was not significant (  χ   2 =0.097,  P =0.104).
Conclusion


IPC using for a short period of time after arthroplasty do not increase the degrees of the pain and the swelling of calf; it can effectively prevent DVT of the lower extremity, improve the quality of sleep in patients, and is good for the limbs rehabilitation.",2020,There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05).,"['deep vein thrombosis (DVT) of lower extremities after arthroplasty', 'deep vein thrombosis of lower extremities after arthroplasty', 'Methods\n\n\nBetween October 2018 and February 2019, 94 patients who planned to undergo unilateral total hip or knee arthroplsty and met the selection criteria']","['intermittent pneumatic compression (IPC', 'intermittent pneumatic compression', 'IPC']","['pre- and post-operative VAS scores and post-operative circumference difference of calf', 'quality of sleep', 'gender, age, surgical site, and surgical reason', 'satisfaction rates of using IPC', 'hospital stay and treatment costs', 'K value and D-dimer before operation', 'sleep assessment score', ""levels of hemoglobin, platelet count, D-dimer, hospital stay, treatment costs, patients' satisfaction with IPC, the parameters of thromboelastrography [kinetics (K value), freezing angle (α angle), reaction time (R value), maximum amplitude (MA value)], visual analogue scale (VAS) score, circumference difference of calf before and after operation, Pittsburgh sleep assessment score, and the incidence of DVT of lower limbs"", 'pre- and post-operative hemoglobin, platelet count, and the other parameters of thromboelastography', 'intermuscular venous thrombosis']","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",,0.0215101,There was no significant difference in the hospital stay and treatment costs between the two groups (  P >0.05).,"[{'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Duan', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Dengbin', 'Initials': 'D', 'LastName': 'Liao', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201907095']
659,31190607,Brain and lesion segmentation in multiple sclerosis using fully convolutional neural networks: A large-scale study.,"OBJECTIVE


To investigate the performance of deep learning (DL) based on fully convolutional neural network (FCNN) in segmenting brain tissues in a large cohort of multiple sclerosis (MS) patients.
METHODS


We developed a FCNN model to segment brain tissues, including T2-hyperintense MS lesions. The training, validation, and testing of FCNN were based on ~1000 magnetic resonance imaging (MRI) datasets acquired on relapsing-remitting MS patients, as a part of a phase 3 randomized clinical trial. Multimodal MRI data (dual-echo, FLAIR, and T1-weighted images) served as input to the network. Expert validated segmentation was used as the target for training the FCNN. We cross-validated our results using the leave-one-center-out approach.
RESULTS


We observed a high average (95% confidence limits) Dice similarity coefficient for all the segmented tissues: 0.95 (0.92-0.98) for white matter, 0.96 (0.93-0.98) for gray matter, 0.99 (0.98-0.99) for cerebrospinal fluid, and 0.82 (0.63-1.0) for T2 lesions. High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2  > 0.92 for all tissues). The cross validation showed consistent results across the centers for all tissues.
CONCLUSION


The results from this large-scale study suggest that deep FCNN can automatically segment MS brain tissues, including lesions, with high accuracy.",2020,High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2  > 0.92 for all tissues).,['segmenting brain tissues in a large cohort of multiple sclerosis (MS) patients'],"['Multimodal MRI data (dual-echo, FLAIR, and T1-weighted images', 'deep learning (DL) based on fully convolutional neural network (FCNN']",['Dice similarity coefficient'],"[{'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue (substance)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}]",[],,0.039133,High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2  > 0.92 for all tissues).,"[{'ForeName': 'Refaat E', 'Initials': 'RE', 'LastName': 'Gabr', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Coronado', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Electrical Engineering, The University of Texas at Tyler, Houston, TX, USA.'}, {'ForeName': 'Sheeba J', 'Initials': 'SJ', 'LastName': 'Sujit', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Allen', 'Affiliation': 'Texas Advanced Computing Center, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Ponnada A', 'Initials': 'PA', 'LastName': 'Narayana', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519856843']
660,31225645,An intervention based on protective factors to improve resilience for breast cancer patients: Study protocol for a randomized controlled trial.,"AIM


To present a study protocol for evaluating the feasibility and effectiveness of an individual face-to-face intervention based on protective factors to improve resilience among breast cancer patients.
BACKGROUND


Research involving the effectiveness of universal interventions to improve resilience for breast cancer patients has seldom been reported and there is an urgent need to find a more acceptable, cost-effective method of providing emotional support. Through health education and psychological interventions, increasing protective factors could promote recovery to the original condition and improve resilience.
DESIGN


A randomized controlled trial of an individual face-to-face intervention.
METHODS


A total of 160 adults diagnosed with confirmed breast cancer will be recruited. The patients will be randomly assigned to the control group (N = 80) or the intervention group (N = 80). An intervention focusing on protective factors will be implemented in the intervention group. A survey of the patients from the two groups will be conducted at baseline, 1, 3, 6, and 12 months. The primary outcome is resilience, measured by the 14-item Resilience Scale. Secondary outcomes include self-efficacy, optimism, perceived social support, and mastery. The Chinese versions of the General Self-Efficacy Scale, revised Life Orientation Test, Multidimensional Scale of Perceived Social Support, and Self-Mastery Scale will be used to measure the four protective factors.
IMPACT


One-to-one and face-to-face interventions have many potential advantages for inpatients, including convenience, accessibility and individuality. Once its effectiveness is confirmed, the intervention will be implemented broadly and make support available for a large number of patients.",2019,"The Chinese versions of the General Self-Efficacy Scale, revised Life Orientation Test, Multidimensional Scale of Perceived Social Support and Self-Mastery Scale will be used to measure the four protective factors.
","['160 adults diagnosed with confirmed breast cancer', 'breast cancer patients']","['individual face-to-face intervention', 'universal interventions']","['General Self-Efficacy Scale, revised Life Orientation Test, Multidimensional Scale of Perceived Social Support and Self-Mastery Scale', 'resilience, measured by the 14-item Resilience Scale', 'self-efficacy, optimism, perceived social support and mastery']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C0582640', 'cui_str': 'Life orientation test (assessment scale)'}, {'cui': 'C0037438'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}]",160.0,0.0550585,"The Chinese versions of the General Self-Efficacy Scale, revised Life Orientation Test, Multidimensional Scale of Perceived Social Support and Self-Mastery Scale will be used to measure the four protective factors.
","[{'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yajuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Shuwen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Maomao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Anhui Medical University, Hefei, China.'}]",Journal of advanced nursing,['10.1111/jan.14108']
661,31781836,"'Intermittent' versus 'continuous' ScvO 2  monitoring in children with septic shock: a randomised, non-inferiority trial.","PURPOSE


To compare the effect of 'intermittent' central venous oxygen saturation (ScvO 2 ) monitoring with 'continuous' ScvO 2  monitoring on shock resolution and mortality in children with septic shock.
METHODS


Primary outcome was the achievement of therapeutic goals or shock resolution in the first 6 h. We randomly assigned children < 17 years' age with septic shock to 'intermittent ScvO 2 ' or 'continuous ScvO 2 ' groups. All children were subjected to subclavian/internal jugular line insertion and managed as per Surviving Sepsis Campaign Guidelines. To guide resuscitation, we used ScvO 2  estimated at other clinical and laboratory parameters were monitored similarly in both groups.
RESULTS


We enrolled 75 and 77 children [median (IQR) age: 6 (1.5-10) years] in the 'intermittent' and 'continuous' groups, respectively. Baseline characteristics were comparable between the groups. When compared to the 'continuous' group, fewer children in the 'intermittent' group achieved shock resolution within first 6 h [19% vs. 36%; relative risk (RR) 0.51; 95% CI 0.29-0.89; risk difference - 18.0%; 95% CI - 32.0 to - 4.0]. The lower bound of confidence interval, however, crossed the pre-specified non-inferiority margin. There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68-1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74-1.51).
CONCLUSIONS


Given that a greater proportion of children attained therapeutic end points in the first 6 h, continuous monitoring of ScvO 2  should preferably be used to titrate therapy in the first few hours in children with septic shock. In the absence of such facility, intermittent monitoring of ScvO 2  can be used to titrate therapy in these children, given the lack of difference in the proportion of patients achieving shock resolution at 24 h or in risk of mortality between the intermittent and continuous groups.",2020,"There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68-1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74-1.51).
","[""We enrolled 75 and 77 children [median (IQR) age: 6 (1.5-10) years] in the 'intermittent' and 'continuous' groups, respectively"", 'children with septic shock', ""randomly assigned children\u2009<\u200917\xa0years' age with septic shock to 'intermittent ScvO 2 ' or 'continuous ScvO 2 ' groups""]","[""Intermittent' versus 'continuous' ScvO 2  monitoring"", ""intermittent' central venous oxygen saturation (ScvO 2 ) monitoring with 'continuous' ScvO 2  monitoring"", 'subclavian/internal jugular line insertion']","['proportion of children attaining shock resolution', 'achievement of therapeutic goals or shock resolution in the first 6\xa0h', 'shock resolution and mortality', 'shock resolution', 'risk of mortality']","[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0589488', 'cui_str': 'Subclavicular approach (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.206973,"There was no difference in the proportion of children attaining shock resolution within 24 h (63% vs. 69%; RR 0.86; 95% CI 0.68-1.08) or risk of mortality between the groups (47% vs. 43%; RR 1.06; 95% CI 0.74-1.51).
","[{'ForeName': 'Jhuma', 'Initials': 'J', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India. jhumaji@gmail.com.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushil Kumar', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",Intensive care medicine,['10.1007/s00134-019-05858-w']
662,31770051,Comparison of immunogenicity between intradermal and intramuscular injections of repeated annual identical influenza virus strains post-pandemic (2011-2012) in COPD patients.,"We compared the antibody responses and persistence of the reduced-dose, 9 µg hemagglutinin (HA)/strain intradermal (ID) injection via the Mantoux technique and the 15 μg HA/strain intramuscular (IM) injection of the repeated annual identical trivalent, inactivated, split-virion vaccine 2011-2012 in chronic obstructive pulmonary disease (COPD) patients. Eighty patients were randomized to ID (n = 41) and IM (n = 39) groups. Four weeks post-vaccination, the antibody responses of the two groups were similar; those for influenza A(H1N1)pdm09 and influenza A(H3N2)-but not influenza B-met the criteria of the Committee for Proprietary Medicinal Products (CPMP). The antibody responses for influenza A(H1N1)pdm09 rapidly declined in both groups, especially with the ID injection, whereas those for influenza A(H3N2) maintained above the CPMP criteria throughout 12 months post-vaccination. The geometric mean titres for influenza A(H1N1)pdm09 persisted above the protective threshold (≥ 40) until 6 months post-vaccination in both the ID and IM groups. The seroprotection rates of the ID and IM groups were above 60% until 3 months and 6 months post-vaccination, respectively. In conclusion, the 9 μg HA/strain ID injection of vaccine 2011-2012 elicited antibody responses similar to the standard dose of 15 μg of the HA/strain IM injection at 4 weeks post-vaccination. However, the antibody responses for influenza A(H1N1)pdm09 rapidly declined, especially in the case of the ID injection, whereas they were comparable for influenza A(H3N2). Additional strategies for increasing vaccine durability should be considered, especially for new pandemic strains affecting elderly COPD patients.",2020,"The seroprotection rates of the ID and IM groups were above 60% until 3 months and 6 months post-vaccination, respectively.","['COPD patients', 'elderly COPD patients', '2011-2012 in chronic obstructive pulmonary disease (COPD) patients', 'Eighty patients']","['hemagglutinin (HA)/strain intradermal (ID) injection via the Mantoux technique and the 15\xa0μg HA/strain intramuscular (IM) injection of the repeated annual identical trivalent, inactivated, split-virion vaccine']","['seroprotection rates', 'geometric mean titres']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",2012.0,0.0280828,"The seroprotection rates of the ID and IM groups were above 60% until 3 months and 6 months post-vaccination, respectively.","[{'ForeName': 'Benjamas', 'Initials': 'B', 'LastName': 'Chuaychoo', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Uraiwan', 'Initials': 'U', 'LastName': 'Kositanont', 'Affiliation': 'Department of Microbiology, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Parichat', 'Initials': 'P', 'LastName': 'Niyomthong', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Nuttapol', 'Initials': 'N', 'LastName': 'Rittayamai', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Sorachai', 'Initials': 'S', 'LastName': 'Srisuma', 'Affiliation': 'Department of Physiology, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok, Thailand.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Rattanasaengloet', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Walaiporn', 'Initials': 'W', 'LastName': 'Wongsrisakunkaew', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Julalux', 'Initials': 'J', 'LastName': 'Thongam', 'Affiliation': 'Department of Physiology, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok, Thailand.'}, {'ForeName': 'Thaweesak', 'Initials': 'T', 'LastName': 'Songserm', 'Affiliation': 'Department of Veterinary Pathology, Kamphaeng Saen, Kasetsart University , Nakhon Pathom, Thailand.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1692559']
663,31230881,"An inactivated enterovirus 71 vaccine is safe and immunogenic in healthy adults: A phase I, double blind, randomized, placebo-controlled, study of two dosages.","BACKGROUND


Hand, foot and mouth disease (HFMD), especially that caused by enterovirus 71 (EV71) infection, is a public health concern in the Asia-Pacific region. We report a phase I clinical trial of an EV71 candidate vaccine (INV21) based on a binary ethylenimine inactivated B2 sub-genotype formulated with aluminum hydroxide.
METHODS


In this double-blind, placebo-controlled, randomized, dose escalation study adult volunteers received two vaccinations 28 days apart of low or high dose formulations of the candidate vaccine and were then monitored for safety and reactogenicity for four weeks after each dose, and for their immune responses up to 28 weeks.
RESULTS


Of 36 adults enrolled, 35 completed the study as planned. Either no or mild adverse events were observed, mainly injection site pain and tiredness. Seroconversion was 100% after two vaccinations. High geometric mean neutralizing antibody titers (GMT) were observed 14 days post first dose, peaking 14 days post second dose (at Day 42) in both high and low dose groups; GMTs on days 14, 28, 42, and 56 were 128, 81, 323, 203 and 144, 100, 451, 351 in low- and high-dose groups, respectively. Titers for both doses declined gradually to Day 196 but remained higher than baseline and the placebo groups, which had low GMTs throughout the duration of the study. Cross-neutralizing antibody activity against heterologous sub-genotypes was demonstrated.
CONCLUSION


These data show that the EV71 candidate vaccine is safe and immunogenic in adults and supports further clinical development as a potential pediatric vaccine by initiating a dose-escalation study for determining the dose-dependent safety and immunogenicity of the vaccine in young naïve children.",2019,"Titers for both doses declined gradually to Day 196 but remained higher than baseline and the placebo groups, which had low GMTs throughout the duration of the study.","['young naïve children', 'healthy adults', '36 adults enrolled, 35 completed the study as planned']","['EV71 candidate vaccine (INV21', 'EV71 candidate vaccine', 'placebo', 'ethylenimine inactivated B2 sub-genotype formulated with aluminum hydroxide']","['High geometric mean neutralizing antibody titers (GMT', 'safety and reactogenicity', 'Seroconversion', 'mild adverse events', 'injection site pain and tiredness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052794', 'cui_str': 'aziridine'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",36.0,0.321554,"Titers for both doses declined gradually to Day 196 but remained higher than baseline and the placebo groups, which had low GMTs throughout the duration of the study.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tambyah', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Oon', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'Rosmonaliza', 'Initials': 'R', 'LastName': 'Asli', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kristanto', 'Affiliation': 'Department of Medicine, NUH Investigational Medicine Unit, Yong Loo Lin School of Medicine, National University of Singapore, 1E, Kent Ridge Road, NUHS Tower Block, Level 10, Singapore 119228, Singapore.'}, {'ForeName': 'Shi-Hsia', 'Initials': 'SH', 'LastName': 'Hwa', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals Asia Pacific Pte Ltd, 21 Biopolis Road, Nucleos South Tower Level 4, Singapore 138567, Singapore.'}, {'ForeName': 'Fue', 'Initials': 'F', 'LastName': 'Vang', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Lovkesh', 'Initials': 'L', 'LastName': 'Karwal', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Fuchs', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Santangelo', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Gilad S', 'Initials': 'GS', 'LastName': 'Gordon', 'Affiliation': 'Takeda Vaccines, Inc., Takeda Pharmaceuticals USA, Fort Collins, CO, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Thomson', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals Asia Pacific Pte Ltd, 21 Biopolis Road, Nucleos South Tower Level 4, Singapore 138567, Singapore.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals Asia Pacific Pte Ltd, 21 Biopolis Road, Nucleos South Tower Level 4, Singapore 138567, Singapore.'}, {'ForeName': 'Hansi', 'Initials': 'H', 'LastName': 'Dean', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA.'}, {'ForeName': 'Subash C', 'Initials': 'SC', 'LastName': 'Das', 'Affiliation': 'Vaccine Business Unit, Takeda Pharmaceuticals USA, 40 Landsdowne Street, Cambridge, MA 02139, USA. Electronic address: subash.das@takeda.com.'}, {'ForeName': 'Dan T', 'Initials': 'DT', 'LastName': 'Stinchcomb', 'Affiliation': 'Takeda Vaccines, Inc., Takeda Pharmaceuticals USA, Fort Collins, CO, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.06.023']
664,31779922,"MRAs in Elderly HF Patients: Individual Patient-Data Meta-Analysis of RALES, EMPHASIS-HF, and TOPCAT.","OBJECTIVES


This study sought to assess the effect of MRA treatment (vs. placebo) in older patients (≥75 years of age) compared with younger patients (<75 years of age) with heart failure (HF).
BACKGROUND


Mineralocorticoid receptor antagonists (MRAs) have been shown to reduce morbidity and mortality in patients with HF with reduced ejection fraction (HFrEF) and in a subset of patients with HF with preserved EF (HFpEF). Notwithstanding, MRAs are underused, especially in the elderly. Pooling the individual patient data (IPD) provided more statistical power with which to assess the efficacy and safety of MRA treatment in this subpopulation.
METHODS


An IPD meta-analysis was performed using Cox proportional hazards models stratified by trial. A total of 1,756 patients (853 randomized to placebo and 903 to MRA) ≥75 years of age, along with 4,411 patients (2,242 randomized to placebo and 2,169 to MRA) <75 years of age were included. The primary outcome was a composite of death from cardiovascular causes or hospitalization for HF.
RESULTS


The treatment groups were well balanced. Patients ≥75 years of age or older and those 80 years of age, 61% were male, 30% had diabetes, and the mean estimated glomerular filtration rate 59 ml/min. The primary outcome occurred in 331 patients (38.8%) in the placebo group versus 281 (31.1%) in the MRA group (hazard ratio: 0.74; 95% confidence interval: 0.63 to 0.86; p < 0.001; and the heterogeneity p value [heterogeneity p = Cochran's Q p value of treatment effect by study interaction] was 0.52). Cardiovascular death and all-cause death were also reduced by MRAs without significant between-trial or age (younger vs. older) heterogeneity. Worsening renal function and hyperkalemia occurred more frequently in patients taking MRAs (vs. placebo). Compared to younger patients, worsening renal function (but not hyperkalemia) was found more frequently in the elderly.
CONCLUSIONS


MRAs reduced morbidity and mortality in elderly patients with HF, a beneficial effect that is more marked in patients with HFrEF but homogenous across HFrEF and HFpEF. Implementation of measures that increase MRA treatment in this population are warranted.",2019,Cardiovascular death and all-cause death were also reduced by MRAs without significant between-trial or age (younger vs. older) heterogeneity.,"['and 2,169 to MRA)\xa0<75 years of age were included', 'patients with HF with reduced ejection fraction (HFrEF) and in a subset of patients with HF with preserved EF (HFpEF', 'older patients (≥75 years of age) compared with younger patients (<75 years of age) with heart failure (HF', 'elderly patients with HF', 'Patients\xa0≥75 years of age or older and those 80 years of age, 61% were male, 30% had diabetes, and the mean estimated glomerular filtration rate 59\xa0ml/min', 'and 903 to MRA)\xa0≥75 years of age, along with 4,411 patients (2,242 randomized to', 'Elderly HF Patients', '1,756 patients (853 randomized to']","['MRA treatment (vs. placebo', 'placebo', 'MRA', 'Mineralocorticoid receptor antagonists (MRAs']","['composite of death from cardiovascular causes or hospitalization for HF', 'Worsening renal function and hyperkalemia', 'efficacy and safety', 'Cardiovascular death and all-cause death', 'worsening renal function', 'morbidity and mortality']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",853.0,0.200384,Cardiovascular death and all-cause death were also reduced by MRAs without significant between-trial or age (younger vs. older) heterogeneity.,"[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France. Electronic address: j.ferreira@chu-nancy.fr.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rossello', 'Affiliation': 'Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain; Department of Cardiology, CIBER de enfermedades Cardio Vasculares, Madrid, Spain.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Eschalier', 'Affiliation': 'Département de Cardiologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Cardiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Centre d'Investigation Clinique-Plurithématique INSERM 1433, and Cardiovascular and Renal Clinical Trialists, INSERM U1116, CHRU Nancy Brabois, Nancy, France.""}]",JACC. Heart failure,['10.1016/j.jchf.2019.08.017']
665,31050167,The effects of high-frequency repetitive transcranial magnetic stimulation on resting-state functional connectivity in obese adults.,"AIMS


We conducted a 4-week randomized, sham-controlled, single-blind, parallel-group trial to examine the effect of repetitive transcranial magnetic stimulation (rTMS) delivered to the left dorsolateral prefrontal cortex (DLPFC) on functional brain connectivity and body weight in adults with obesity.
MATERIALS AND METHODS


Of the 45 volunteers with obesity, aged between 18 and 70 years (body mass index [BMI] ≥25 kg/m 2  according to the obesity criterion for an Asian population), 36 participants (54.1 ± 11.0 years, BMI 30.2 ± 3.5 kg/m 2  , 77.8% female) completed the 4 weeks of follow-up, undergoing two resting state fMRI scans (20 in the real stimulation group and 16 in the sham stimulation group). A total of eight sessions of high-frequency rTMS targeting the left DLPFC were provided over a period of 4 weeks (5-second trains with 25-second inter-train intervals, 10 Hz, 110% motor threshold; 2000 pulses over 20 minutes).
RESULTS


Participants in the real stimulation group showed significantly greater weight loss from baseline following the eight session of rTMS (-2.53 ± 2.41 kg vs 0.38 ± 1.13 kg, P < 0.01). For intrinsic brain connectivity comparisons, the between-ness centrality values within the right frontoparietal network tended to increase with rTMS, and a significant interaction effect was identified for time (pre vs post) × rTMS (real vs sham) in the right frontoparietal network (P = 0.031, FDR corrected).
CONCLUSIONS


We observed that rTMS selectively increased resting state functional connectivity within the right frontoparietal network. Our findings suggest that high-frequency rTMS to the left DLPFC might strengthen the frontoparietal network that orchestrates top-down inhibitory control to reduce food intake.",2019,We observed that rTMS selectively increased resting state functional connectivity within the right frontoparietal network.,"['obese adults', 'Of the 45 volunteers with obesity, aged between 18 and 70\u2009years (body mass index', 'adults with obesity', 'Asian population), 36 participants (54.1 ±\u200911.0 years, BMI 30.2 ± 3.5 kg/m 2  , 77.8% female) completed the 4\u2009weeks of follow-up, undergoing two resting state fMRI scans (20 in the real stimulation group and 16 in the sham stimulation group']","['high-frequency repetitive transcranial magnetic stimulation', 'rTMS', 'left dorsolateral prefrontal cortex (DLPFC', 'repetitive transcranial magnetic stimulation (rTMS']","['functional brain connectivity and body weight', 'resting state functional connectivity', 'weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441633'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",45.0,0.0923669,We observed that rTMS selectively increased resting state functional connectivity within the right frontoparietal network.,"[{'ForeName': 'Se-Hong', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ""Department of Family Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bo-Yong', 'Initials': 'BY', 'LastName': 'Park', 'Affiliation': 'Department of Electrical and Computer Engineering, Sungkyunkwan University, Suwon, Republic of Korea.'}, {'ForeName': 'Kyoungseob', 'Initials': 'K', 'LastName': 'Byeon', 'Affiliation': 'Department of Electrical and Computer Engineering, Sungkyunkwan University, Suwon, Republic of Korea.'}, {'ForeName': 'Hyunjin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Center for Neuroscience Imaging Research, Institute for Basic Science (IBS), Suwon, Republic of Korea.'}, {'ForeName': 'Youngkook', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ""Department of Rehabilitation Medicine, College of Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Young-Mi', 'Initials': 'YM', 'LastName': 'Eun', 'Affiliation': ""Department of Family Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Ju-Hye', 'Initials': 'JH', 'LastName': 'Chung', 'Affiliation': ""Department of Family Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13763']
666,31169568,Gabapentin and Memantine for Treatment of Acquired Pendular Nystagmus: Effects on Visual Outcomes.,"BACKGROUND


The most common causes of acquired pendular nystagmus (APN) are multiple sclerosis (MS) and oculopalatal tremor (OPT), both of which result in poor visual quality of life. The objective of our study was to evaluate the effects of memantine and gabapentin treatments on visual function. We also sought to correlate visual outcomes with ocular motor measures and to describe the side effects of our treatments.
METHODS


This study was single-center cross-over trial. A total of 16 patients with chronic pendular nystagmus, 10 with MS and 6 with OPT were enrolled. Visual acuity (in logarithm of the minimum angle of resolution [LogMAR]), oscillopsia amplitude and direction, eye movement recordings, and visual function questionnaires (25-Item National Eye Institute Visual Functioning Questionnaire [NEI-VFQ-25]) were performed before and during the treatments (gabapentin: 300 mg 4 times a day and memantine: 10 mg 4 times a day).
RESULTS


A total of 29 eyes with nystagmus were evaluated. Median near monocular visual acuity improved in both treatment arms, by 0.18 LogMAR on memantine and 0.12 LogMAR on gabapentin. Distance oscillopsia improved on memantine and on gabapentin. Median near oscillopsia did not significantly change on memantine or gabapentin. Significant improvement in ocular motor parameters was observed on both treatments. Because of side effects, 18.8% of patients discontinued memantine treatment-one of them for a serious adverse event. Only 6.7% of patients discontinued gabapentin. Baseline near oscillopsia was greater among those with higher nystagmus amplitude and velocity.
CONCLUSIONS


This study demonstrated that both memantine and gabapentin reduce APN, improving functional visual outcomes. Gabapentin showed a better tolerability, suggesting that this agent should be used as a first-line agent for APN. Data from our investigation emphasize the importance of visual functional outcome evaluations in clinical trials for APN.",2020,"Median near monocular visual acuity improved in both treatment arms, by 0.18 LogMAR on memantine and 0.12 LogMAR on gabapentin.","['16 patients with chronic pendular nystagmus, 10 with MS and 6 with OPT were enrolled', 'Acquired Pendular Nystagmus', '29 eyes with nystagmus']","['Gabapentin and Memantine', 'memantine and gabapentin', 'Gabapentin', 'memantine', 'gabapentin']","['Baseline near oscillopsia', 'Median near oscillopsia', 'Distance oscillopsia', 'functional visual outcomes', 'Median near monocular visual acuity', 'visual function', 'Visual acuity (in logarithm of the minimum angle of resolution [LogMAR]), oscillopsia amplitude and direction, eye movement recordings, and visual function questionnaires (25-Item National Eye Institute Visual Functioning Questionnaire [NEI-VFQ-25', 'ocular motor parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0271388', 'cui_str': 'Pendular Nystagmus'}, {'cui': 'C1282963', 'cui_str': 'Acquired pendular nystagmus (disorder)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus, Pathologic'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0422980', 'cui_str': 'Movement of visual image - finding'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",16.0,0.125518,"Median near monocular visual acuity improved in both treatment arms, by 0.18 LogMAR on memantine and 0.12 LogMAR on gabapentin.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Nerrant', 'Affiliation': ""Hospices Civils de Lyon (EN, LA, FP-V, A-LV, AV, CT), Neuro-Ophthalmology and Neuro-Cognition Unit, Hôpital Neurologique Pierre Wertheimer, Bron, France; Lyon I University (EN, SV, JB, AV, CT), Lyon, France; Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation, Hôpital Neurologique Pierre Wertheimer, Bron, France; INSERM U1028 CNRS UMR5292 Lyon Neuroscience Center, Team ImpAct (AV, CT) and Observatoire Français de la Sclérose en Plaques (SV), Bron, France; Hospices Civils de Lyon (JB), Pôle Information Médicale Evaluation Recherche Unit, Equipe d'Accueil 4129, Bron, France; and Hospices Civils de Lyon (BC), Pharmacie Department, Hôpital Neurologique Pierre Wertheimer, Bron, France.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Abouaf', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pollet-Villard', 'Affiliation': ''}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Vie', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vukusic', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Berthiller', 'Affiliation': ''}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Colombet', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vighetto', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Tilikete', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000807']
667,32410152,Letter to the Editor Re: Sera of Obese Type 2 Diabetic Patients Undergoing Metabolic Surgery Instead of Conventional Treatment Exert Beneficial Effects on Beta Cell Survival and Function: Results of a Randomized Clinical Study.,,2020,,['Sera of Obese Type 2 Diabetic Patients Undergoing'],"['Metabolic Surgery', 'Letter to the Editor Re']",['Beta Cell Survival and Function'],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0341806,,"[{'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Pories', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA. poriesw@ecu.edu.'}, {'ForeName': 'G Lynis', 'Initials': 'GL', 'LastName': 'Dohm', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA.'}]",Obesity surgery,['10.1007/s11695-020-04665-3']
668,31739276,The impact of internet-delivered cognitive behavioural therapy for health anxiety on cyberchondria.,"Cyberchondria refers to an emotional-behavioural pattern whereby excessive online searches lead to increased anxiety about one's own health status. It has been shown to be associated with health anxiety, however it is unknown whether existing cognitive behavioural therapy (CBT) interventions targeting health anxiety also improve cyberchondria. This study aimed to determine whether internet-delivered cognitive behavioural therapy (iCBT) for severe health anxiety led to improvements in self-reported cyberchondria and whether improvements in cyberchondria were associated with improvements in health anxiety observed during treatment. Methods: We analysed secondary data from a randomised controlled trial (RCT) comparing an iCBT group (n = 41) to an active control group who underwent psychoeducation, monitoring and clinical support (n = 41) in health anxious patients with a DSM-5 diagnosis of Illness Anxiety Disorder and/or Somatic Symptom Disorder. The iCBT group showed a significantly greater reduction in cyberchondria compared to the control group, with large differences at post-treatment on the Cyberchondria Severity Scale Total scale (CSS; Hedges g = 1.09), and the Compulsion, Distress, Excessiveness subscales of the CSS (g's: 0.8-1.13). Mediation analyses showed improvements in health anxiety in the iCBT group were mediated by improvements in all of the CSS subscales, except for the Mistrust subscale. Conclusions: Internet CBT for health anxiety improves cyberchondria.",2020,"The iCBT group showed a significantly greater reduction in cyberchondria compared to the control group, with large differences at post-treatment on the Cyberchondria Severity Scale Total scale (CSS; Hedges g = 1.09), and the Compulsion, Distress, Excessiveness subscales of the CSS (g's: 0.8-1.13).","['health anxious patients with a DSM-5 diagnosis of Illness Anxiety Disorder and/or Somatic Symptom Disorder', 'health anxiety on cyberchondria']","['internet-delivered cognitive behavioural therapy (iCBT', 'cognitive behavioural therapy (CBT) interventions', 'internet-delivered cognitive behavioural therapy', 'active control group who underwent psychoeducation, monitoring and clinical support (n\u202f=\u202f41', 'iCBT']","['Cyberchondria Severity Scale Total scale', 'health anxiety', 'Compulsion, Distress, Excessiveness subscales', 'cyberchondria']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4064938', 'cui_str': 'Illness anxiety disorder'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4552535', 'cui_str': 'Cyberchondria'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C4552535', 'cui_str': 'Cyberchondria'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0557165,"The iCBT group showed a significantly greater reduction in cyberchondria compared to the control group, with large differences at post-treatment on the Cyberchondria Severity Scale Total scale (CSS; Hedges g = 1.09), and the Compulsion, Distress, Excessiveness subscales of the CSS (g's: 0.8-1.13).","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': ""School of Psychology, UNSW Sydney, 1302 Mathews Building, Randwick, NSW, 2052, Australia; Clinical Research Unit for Anxiety and Depression (CRUfAD), School of Psychiatry, UNSW Sydney at St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW, Sydney, 2010, Australia. Electronic address: j.newby@unsw.edu.au.""}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'McElroy', 'Affiliation': 'Department of Neuroscience, Psychology and Behaviour, University of Leicester, University Road, Leicester, LE1 7RH, UK.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102150']
669,31178377,"A randomized, open-labelled, non-inferiority phase 4 clinical trial to evaluate the immunogenicity and safety of the live, attenuated, oral rotavirus vaccine, ROTAVAC® in comparison with a licensed rotavirus vaccine in healthy infants.","BACKGROUND


ROTAVAC® (nHRV), derived naturally from the human 116E rotavirus (RV) neonatal strain, was licensed in India in 2015 based on promising results of a phase 3, safety and efficacy vaccine trial. As a pre-requisite for WHO prequalification, we compared the immunogenicity and safety of ROTAVAC® to those of a WHO-prequalified, Rotarix®.
METHODS


We conducted a multicentre, open-labeled, randomized phase 4 clinical trial where 464 infants, 6-8 weeks of age were equally randomized to receive as licensed, the complete regimen of ROTAVAC® (3 doses; Group I) or Rotarix® (2 doses; Group II). Antibody responses (serum anti-RV Immunoglobulin A [IgA]) were measured by enzyme-linked immunosorbent assay (ELISA). The primary analysis was an assessment of non-inferiority of ROTAVAC® to Rotarix® for geometric mean concentration (GMC) for infants who received the complete regimen of either vaccine.
RESULTS


The GMC for Group I was 20.4 (95%CI: 17.6, 23.6) and that for Group II was 24.8 (95%CI: 20.3, 30.3), the GMC ratio was 0.82 (95% CI: 0.64, 1.05), thus meeting the non-inferiority criterion. Site-wise analysis of GMC titres revealed that one site had a peculiar pre-vaccination titre affecting only ROTAVAC® post-vaccination GMCs. Seroconversion rates were 35.3% (95%CI: 29.0, 41.9) and 31.0% (95%CI: 25.1, 37.4) for Groups I and Group II, respectively. There was no substantive difference in safety profiles between both vaccines.
CONCLUSIONS


The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile. Because the demand for RV vaccines is increasing as more countries are expanding their immunization schedules, the lack of need of a buffering agent, low dose volume (0.5 mL), non-interference with other concomitantly administered vaccines, and conformance with WHO-prequalification requirements provide ROTAVAC® the potential for widespread global usage. Post completion of this study, ROTAVAC® is now a WHO-prequalified vaccine.
CLINICAL TRIALS REGISTRATION


(CTRI Number: CTRI/2015/12/006428).",2019,The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile.,"['464 infants, 6-8\u202fweeks of age', 'healthy infants']","['oral rotavirus vaccine, ROTAVAC®', 'ROTAVAC®', 'Rotarix®']","['Antibody responses (serum anti-RV Immunoglobulin A [IgA', 'Seroconversion rates', 'GMC ratio', 'immunogenicity and safety', 'safety profiles']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",464.0,0.23004,The complete regimen of ROTAVAC® demonstrated immunological non-inferiority to the complete regimen of Rotarix® with a clinically acceptable safety profile.,"[{'ForeName': 'Raches', 'Initials': 'R', 'LastName': 'Ella', 'Affiliation': 'Bharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Babji', 'Affiliation': 'Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Ciarlet', 'Affiliation': 'Independent Clinical Development Consultant, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Blackwelder', 'Affiliation': 'Independent Clinical Development Consultant, USA.'}, {'ForeName': 'Krishna Mohan', 'Initials': 'KM', 'LastName': 'Vadrevu', 'Affiliation': 'Bharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India. Electronic address: kmohan@bharatbiotech.com.'}]",Vaccine,['10.1016/j.vaccine.2019.05.069']
670,31179773,"Clinical evaluation of an oral mucoadhesive film containing chitosan for the treatment of recurrent aphthous stomatitis: a randomized, double-blind study.","Objective:  To assess the efficacy and safety of an oral mucoadhesive film containing chitosan for the treatment of recurrent aphthous stomatitis (RAS). Methods:  Seventy-two subjects with RAS were recruited to this randomized, parallel-controlled, double-blind clinical trial. The participants were randomly allocated to the test group or the control group. Demographic data were recorded at baseline. The use of the film was demonstrated. Pain score (visual analog scale), adverse effects, ulcer size were recorded on day 1 (baseline), day 2, day 4, and day 6. Results:  The reduction in ulcer size was significantly greater ( p <.05) in the treatment group (2.91 ± 3.66) than in the control group (1.10 ± 2.26) between days 4 and 6. There was no significant difference between the treatment and control groups in the pain score, ulcer size, or reduction in the pain score ( p >.05). No obvious adverse effects were observed. Conclusions:  The oral mucoadhesive film containing chitosan promotes oral ulcer healing and can be used as a drug carrier in treating oral ulcers. Trial registration number:  ChiCTR-IOR-16008970.",2020,"There was no significant difference between the treatment and control groups in the pain score, ulcer size, or reduction in the pain score ( p >.05).","['Methods:  Seventy-two subjects with RAS', 'recurrent aphthous stomatitis', 'recurrent aphthous stomatitis (RAS']",['oral mucoadhesive film containing chitosan'],"['pain score, ulcer size, or reduction in the pain score', 'adverse effects', 'Pain score (visual analog scale), adverse effects, ulcer size', 'reduction in ulcer size', 'efficacy and safety']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C2937365', 'cui_str': 'Recurrent aphthous ulcer (disorder)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",72.0,0.135335,"There was no significant difference between the treatment and control groups in the pain score, ulcer size, or reduction in the pain score ( p >.05).","[{'ForeName': 'Yanxiong', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Haiwen', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Department of Oral Mucosal Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1610548']
671,32492105,A Randomized Trial of Convalescent Plasma for COVID-19-Potentially Hopeful Signals.,,2020,,[],[],[],[],[],[],,0.04554,,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Casadevall', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Liise-Anne', 'Initials': 'LA', 'LastName': 'Pirofski', 'Affiliation': 'Montefiore Medical Center, Division of Infectious Diseases, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York.'}]",JAMA,['10.1001/jama.2020.10218']
672,31077798,Pain-Induced Reduction in Corticomotor Excitability Is Counteracted by Combined Action-Observation and Motor Imagery.,"Musculoskeletal pain reduces corticomotor excitability (CE) and methods modulating such CE reduction remain elusive. This study aimed to modulate pain-induced CE reduction by performing action observation and motor imagery (AOMI) during experimental muscle pain. Twelve healthy participants participated in 3 cross-over and randomized sessions separated by 1 week. During the AOMI session subjects performed an AOMI task for 10 minutes. In the AOMI+PAIN session, hypertonic saline was injected in the first dorsal interosseous muscle before performing the AOMI task. In the PAIN session, participants remained at rest for 10 minutes or until pain-resolve after the hypertonic saline injection. CE was assessed using transcranial magnetic stimulation motor-evoked potentials (TMS-MEPs) of the first dorsal interosseous muscle at baseline, during, immediately after, and 10 minutes after AOMI and/or PAIN. Facilitated TMS-MEPs were found after 2 and 4 minutes of AOMI performance (P < .017) whereas a reduction in TMS-MEPs occurred at 4 minutes (P < .017) during the PAIN session. Performing the AOMI task during pain counteracted the reduction in CE, as evident by no change in TMS-MEPs during the AOMI+PAIN session (P > .017). Pain intensity was similar between the AOMI+PAIN and PAIN sessions (P = .71). This study, which may be considered a pilot, demonstrated the counteracting effects of AOMI on pain-induced decreases in CE and warrants further studies in a larger population. PERSPECTIVE: This is the first study to demonstrate a method counteracting the reduction in CE associated with acute pain and advances therapeutic possibilities for individuals with chronic musculoskeletal pain.",2019,Facilitated TMS-MEPs were found after 2 and 4 minutes of AOMI performance (P < .017),"['individuals with chronic musculoskeletal pain', 'Twelve healthy participants participated in 3 cross-over and randomized sessions separated by 1 week']","['CE reduction by performing action observation and motor imagery (AOMI', 'hypertonic saline']","['Facilitated TMS-MEPs', 'Pain intensity', 'TMS-MEPs', 'AOMI performance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",12.0,0.0473121,Facilitated TMS-MEPs were found after 2 and 4 minutes of AOMI performance (P < .017),"[{'ForeName': 'Dennis Boye', 'Initials': 'DB', 'LastName': 'Larsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University, Faculty of Medicine, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University, Faculty of Medicine, Aalborg, Denmark.'}, {'ForeName': 'Shellie Ann', 'Initials': 'SA', 'LastName': 'Boudreau', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University, Faculty of Medicine, Aalborg, Denmark. Electronic address: sboudreau@hst.aau.dk.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.05.001']
673,31705869,Does Watching Videos Increase the Perioperative Anxiety in Patients Undergoing Third Molar Surgery? A Randomized Trial.,"PURPOSE


The extraction of third molar teeth has usually been associated with a high level of anxiety, mainly from a lack of knowledge. We compared the effect of different informed consent formats on the perioperative anxiety level of patients scheduled for third molar surgery and explored the effects of watching a video about the surgical procedure from the Internet before the procedure on the patients' anxiety level.
PATIENTS AND METHODS


A total of 113 patients who had been admitted for the removal of impacted third molars were randomly divided into control (verbal information) and study (video plus verbal information) groups. The anxiety level was assessed using the Amsterdam Preoperative Anxiety and Information Scale, Modified Dental Anxiety Scale, and Spielberger's State-Trait Anxiety Inventory. Pain was evaluated using the visual analog scale (VAS).
RESULTS


The results showed that the study group had higher anxiety scores than the control group immediately after the consent process (P < .05). In all groups, the anxiety levels showed a decreasing trend after surgery. The VAS scores did not show significant differences when stratified by gender or educational level. No correlation was observed between age and the other variables.
CONCLUSIONS


According to our results, the patients who watched the procedural video in an uncontrolled situation from websites before the operation were prone to high anxiety. The verbal and written consent format resulted in satisfactory anxiety management. Further studies are needed to clarify whether the use of video consent with different formats, such as animation, would be more effective in managing anxiety when applied carefully and under the control of a clinician.",2020,"The anxiety level was assessed using the Amsterdam Preoperative Anxiety and Information Scale, modified Dental Anxiety Scale, and Spielberger's State-Trait Anxiety Inventory.","['Patients Undergoing Third Molar Surgery', 'patients scheduled for third molar surgery', '113 patients who had been admitted for the removal of impacted third molars']",[],"['satisfactory anxiety management', 'anxiety level', 'VAS scores', 'perioperative anxiety level', ""Amsterdam Preoperative Anxiety and Information Scale, modified Dental Anxiety Scale, and Spielberger's State-Trait Anxiety Inventory"", 'higher anxiety scores', 'visual analog scale (VAS', 'Pain', 'anxiety levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",113.0,0.0223064,"The anxiety level was assessed using the Amsterdam Preoperative Anxiety and Information Scale, modified Dental Anxiety Scale, and Spielberger's State-Trait Anxiety Inventory.","[{'ForeName': 'Mehmet Melih', 'Initials': 'MM', 'LastName': 'Omezli', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ordu University, Ordu, Turkey.'}, {'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Torul', 'Affiliation': 'Research Assistant, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ordu University, Ordu, Turkey. Electronic address: damlatorul@gmail.com.'}, {'ForeName': 'Kadircan', 'Initials': 'K', 'LastName': 'Kahveci', 'Affiliation': 'Research Assistant, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ordu University, Ordu, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.027']
674,31145833,Association between advanced cancer patient-caregiver agreement regarding prognosis and hospice enrollment.,"BACKGROUND


Patients with advanced, incurable cancer who understand their illness is incurable are more likely to prefer hospice care at the end of life compared with patients who believe their illness is curable. To the authors' knowledge, it is unclear whether patient-caregiver agreement regarding perceived prognosis is associated with hospice enrollment.
METHODS


The current study examined the prospective relationship between patient-caregiver agreement concerning perceived prognosis and hospice enrollment in the last 30 days of life. Data were collected during a cluster randomized controlled trial examining a communication intervention for oncologists and patients with advanced cancer and their caregivers. At the time of study entry, patients and caregivers (141 dyads) were categorized as endorsing a ""good"" prognosis if they: 1) reported a >50% chance of surviving ≥2 years; or if they 2) predicted that the patient's quality of life 3 months into the future would be ≥7 on an 11-point scale.
RESULTS


Approximately one-fifth of dyads agreed on a poor prognosis whereas approximately one-half disagreed regarding prognosis. In approximately one-third of dyads, patients and caregivers both believed the patient's future quality of life would be good (34%) and that the patient would live for ≥2 years (30%). Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
CONCLUSIONS


Dyadic understanding of patients' projected life expectancy and future quality of life appears to be predictive of care received at the end of life. Improving rates of hospice enrollment may be best achieved with dyadic interventions.",2019,"Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
","['Patients with advanced, incurable cancer', 'oncologists and patients with advanced cancer and their caregivers']",['communication intervention'],"['life expectancy and future quality of life', 'life expectancy and poor future quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0034380'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",,0.12627,"Patients in these dyads were less likely to enroll in hospice compared with patients in dyads who disagreed and those who agreed on a shorter life expectancy and poor future quality of life.
","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Trevino', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Megan Johnson', 'Initials': 'MJ', 'LastName': 'Shen', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Department of Pediatrics, University of California at Davis, Davis, California.'}, {'ForeName': 'Guibo', 'Initials': 'G', 'LastName': 'Xing', 'Affiliation': 'Department of Pediatrics, University of California at Davis, Davis, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoerger', 'Affiliation': 'Department of Psychology, Tulane University, New Orleans, Louisiana.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Family Medicine, University of Rochester Medical Center, Rochester, New York.'}]",Cancer,['10.1002/cncr.32188']
675,31753895,"Efficacy of  Bifidobacterium longum, B. infantis and Lactobacillus acidophilus  probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study protocol.","INTRODUCTION


The healthy 'eubiosis' microbiome in infancy is regarded as the microbiome derived from term, vaginally delivered, antibiotic free, breastfed infants at 4-6 months. Dysbiosis is regarded as a deviation from a healthy state with reduced microbial diversity and deficient capacity to control drug-resistant organisms. Preterm infants are highly sensitive to early gut dysbiosis. Latter has been associated with sepsis and necrotising enterocolitis, but may also contribute to long-term health problems. Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
METHODS AND ANALYSIS


A randomised, double blind, placebo-controlled study has been designed to assess the safety and efficacy of the probiotic mix of  Bifidobacterium longum  and  infantis  and  Lactobacillus acidophilus  in the prevention of gut dysbiosis in preterm infants between 28+0 and 32+6 weeks of gestation. The study is conducted in 18 German neonatal intensive care units. Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation will be randomised in the first 48 hours of life to 28 days of once daily treatment with either probiotics or placebo. The efficacy endpoint is the prevention of gut dysbiosis at day 30 of life. A compound definition of gut dysbosis is used: (1) colonisation with multidrug-resistant organisms or gram-negative bacteria with high epidemic potential or (2) a significant deviation of the gut microbiota composition as compared with healthy term infants. Dysbiosis is determined by (1) conventional microbiological culture and (2) phylogenetic microbiome analysis by high-throughput 16S rRNA and metagenome sequencing. Persistence of dysbiosis will be assessed at 12-month follow-up visits. Side effects and adverse events related to the intervention will be recorded. Key secondary endpoint(s) are putative consequences of dysbiosis. A subgroup of infants will be thoroughly phenotyped for immune parameters using chipcytometry.
ETHICS AND DISSEMINATION


Ethics approval was obtained in all participating sites. Results of the trial will be published in peer-review journals, at scientific meetings, on the website (www.primal-study.de) and via social media of parent organisations.
TRIAL REGISTRATION NUMBER


DRKS00013197; Pre-results.",2019,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","['Preterm infants', 'preterm infants between 28+0\u2009and 32+6 weeks of gestation', 'preterm infants of 28+0-32+6 weeks of gestation', 'Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation', '18 German neonatal intensive care units', 'healthy term infants']","['placebo', 'Bifidobacterium longum, B. infantis and Lactobacillus acidophilus  probiotics', 'probiotics or placebo']","['safety and efficacy', 'Side effects and adverse events']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",654.0,0.386743,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Marißen', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haiß', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Van Rossum', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Bünte', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Frommhold', 'Affiliation': ""Children's Hospital Memmingen, Memmingen, Germany.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gille', 'Affiliation': 'Department of Neonatology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Sybelle', 'Initials': 'S', 'LastName': 'Goedicke-Fritz', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Hudalla', 'Affiliation': 'Department of Neonatology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pagel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Pirr', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Siller', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Viemann', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Vens', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Inke', 'Initials': 'I', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Gehring', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Bork', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Henneke', 'Affiliation': 'Insitute for Immunodeficiency (CCI) and Centre for Paediatrics and Adolescent Medicine, Medical Centre and Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Härtel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany christoph.haertel@uksh.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032617']
676,30851351,HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): A Randomized Controlled Trial of Hyperbaric Oxygen to Prevent Osteoradionecrosis of the Irradiated Mandible After Dentoalveolar Surgery.,"PURPOSE


Hyperbaric oxygen (HBO) has been advocated in the prevention and treatment of osteoradionecrosis (ORN) of the jaw after head and neck radiation therapy, but supporting evidence is weak. The aim of this randomized trial was to establish the benefit of HBO in the prevention of ORN after high-risk surgical procedures to the irradiated mandible.
METHODS AND MATERIALS


HOPON was a randomized, controlled, phase 3 trial. Participants who required dental extractions or implant placement in the mandible with prior radiation therapy >50 Gy were recruited. Eligible patients were randomly assigned 1:1 to receive or not receive HBO. All patients received chlorhexidine mouthwash and antibiotics. For patients in the HBO arm, oxygen was administered in 30 daily dives at 100% oxygen to a pressure of 2.4 atmospheres absolute for 80 to 90 minutes. The primary outcome measure was the diagnosis of ORN 6 months after surgery, as determined by a blinded central review of clinical photographs and radiographs. The secondary endpoints included grade of ORN, ORN at other time points, acute symptoms, pain, and quality of life.
RESULTS


A total of 144 patients were randomized, and data from 100 patients were analyzed for the primary endpoint. The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13; 95% confidence interval, 0.14-8.92; P = 1). Patients in the hyperbaric arm had fewer acute symptoms but no significant differences in late pain or quality of life. Dropout was higher in the HBO arm, but the baseline characteristics of the groups that completed the trial were comparable between the 2 arms.
CONCLUSIONS


The low incidence of ORN makes recommending HBO for dental extractions or implant placement in the irradiated mandible unnecessary. These findings are in contrast with a recently published Cochrane review and previous trials reporting rates of ORN (non-HBO) of 14% to 30% and challenge a long-established standard of care.",2019,"The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13;","['Participants who required dental extractions or implant placement in the mandible with prior radiation therapy', '144 patients were randomized, and data from 100 patients were analyzed for the primary endpoint', '50\xa0Gy were recruited', 'Eligible patients', 'Osteoradionecrosis']","['HOPON (Hyperbaric Oxygen', 'Hyperbaric oxygen (HBO', 'HBO', 'Hyperbaric Oxygen', 'chlorhexidine mouthwash and antibiotics']","['incidence of ORN', 'diagnosis of ORN 6\xa0months after surgery, as determined by a blinded central review of clinical photographs and radiographs', 'late pain or quality of life', 'grade of ORN, ORN at other time points, acute symptoms, pain, and quality of life', 'acute symptoms']","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0029461', 'cui_str': 'Osteoradionecrosis'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3666901', 'cui_str': 'Chlorhexidine Mouthwash [Paroex]'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",144.0,0.307039,"The incidence of ORN at 6 months was 6.4% and 5.7% for the HBO and control groups, respectively (odds ratio, 1.13;","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom. Electronic address: rjshaw@liv.ac.uk.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Butterworth', 'Affiliation': 'Maxillofacial Prosthodontics, Department of Maxillofacial Surgery, University Hospital Aintree, Liverpool, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Silcocks', 'Affiliation': 'Cancer Research UK Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Binyam T', 'Initials': 'BT', 'LastName': 'Tesfaye', 'Affiliation': 'Cancer Research UK Liverpool Cancer Trials Unit, Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bickerstaff', 'Affiliation': 'Cancer Research UK Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Cancer Research UK Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Anastios', 'Initials': 'A', 'LastName': 'Kanatas', 'Affiliation': 'OMFS Department, Leeds Dental Institute, Leeds, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nixon', 'Affiliation': 'Restorative Department, Leeds Dental Institute, Leeds, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCaul', 'Affiliation': 'Regional Maxillofacial Unit, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Prav', 'Initials': 'P', 'LastName': 'Praveen', 'Affiliation': 'Maxillofacial Office, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Lowe', 'Affiliation': 'Aberdeen Royal Infirmary, Aberdeen, Scotland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Blanco-Guzman', 'Affiliation': 'Maxillofacial Unit, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, United Kingdom.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Forner', 'Affiliation': 'Departments of Anesthesia and Oral and Maxillofacial Surgery, Centre of Head and Orthopedics, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Maxillofacial Unit, Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fardy', 'Affiliation': 'University Hospital of Wales, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Parkin', 'Affiliation': 'OMFS Department, ABUHB, Newport, Wales, United Kingdom.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Smerdon', 'Affiliation': 'DDRC Healthcare, Hyperbaric Medical Centre, Plymouth, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, Scotland.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Cope', 'Affiliation': 'North West Recompression Unit, Murrayfield Hospital, Holmwood, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Glover', 'Affiliation': ""Hyperbaric Medicine Unit, St. Richard's Hospital, Chichester, United Kingdom.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2019.02.044']
677,31091527,"Topiramate plus Cooling for Hypoxic-Ischemic Encephalopathy: A Randomized, Controlled, Multicenter, Double-Blinded Trial.","BACKGROUND AND OBJECTIVES


Therapeutic interventions to improve the efficacy of whole-body cooling for hypoxic-ischemic encephalopathy (HIE) are desirable. Topiramate has been effective in reducing brain damage in experimental studies. However, in the clinical setting information is limited to a small number of feasibility trials. We launched a randomized controlled double-blinded topiramate/placebo multicenter trial with the primary objective being to reduce the antiepileptic activity in cooled neonates with HIE and assess if brain damage would be reduced as a consequence.
STUDY DESIGN


Neonates were randomly assigned to topiramate or placebo at the initiation of hypothermia. Topiramate was administered via a nasogastric tube. Brain electric activity was continuously monitored. Topiramate pharmacokinetics, energy-related and Krebs' cycle intermediates, and lipid peroxidation biomarkers were determined using liquid chromatography-mass spectrometry and MRI for assessing brain damage.
RESULTS


Out of 180 eligible patients 110 were randomized, 57 (51.8%) to topiramate and 53 (48.2%) to placebo. No differences in the perinatal or postnatal variables were found. The topiramate group exhibited less seizure burden in the first 24 h of hypothermia (topiramate, n = 14 [25.9%] vs. placebo, n = 22 [42%]); needed less additional medication, and had lower mortality (topiramate, n = 5 [9.2%] vs. placebo, n = 10 [19.2%]); however, these results did not achieve statistical significance. Topiramate achieved a therapeutic range in 37.5 and 75.5% of the patients at 24 and 48 h, respectively. A significant association between serum topiramate levels and seizure activity (p < 0.016) was established. No differences for oxidative stress, energy-related metabolites, or MRI were found.
CONCLUSIONS


Topiramate reduced seizures in patients achieving therapeutic levels in the first hours after treatment initiation; however, they represented only a part of the study population. Our results warrant further studies with higher loading and maintenance dosing of topiramate.",2019,A significant association between serum topiramate levels and seizure activity (p < 0.016) was established.,"['180 eligible patients 110', 'Neonates', 'cooled neonates with HIE', 'Hypoxic-Ischemic Encephalopathy']","['topiramate', 'placebo', 'topiramate or placebo', 'Topiramate', 'topiramate/placebo', 'Topiramate plus Cooling']","['seizure burden', 'oxidative stress, energy-related metabolites, or MRI', 'Brain electric activity', 'lower mortality', 'antiepileptic activity', ""Topiramate pharmacokinetics, energy-related and Krebs' cycle intermediates, and lipid peroxidation biomarkers"", 'perinatal or postnatal variables', 'therapeutic range', 'serum topiramate levels and seizure activity']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic-Ischemic Encephalopathy'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1271826', 'cui_str': 'Serum topiramate level'}]",180.0,0.53915,A significant association between serum topiramate levels and seizure activity (p < 0.016) was established.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nuñez-Ramiro', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Benavente-Fernández', 'Affiliation': 'Division of Neonatology, University Hospital Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Valverde', 'Affiliation': 'Division of Neonatology, University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Malaika', 'Initials': 'M', 'LastName': 'Cordeiro', 'Affiliation': 'Division of Neonatology, University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Dorotea', 'Initials': 'D', 'LastName': 'Blanco', 'Affiliation': 'Division of Neonatology, University Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Boix', 'Affiliation': ""Department of Neonatology, University Hospital Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cabañas', 'Affiliation': 'Division of Neonatology, University Hospital Quirónsalud Madrid, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Chaffanel', 'Affiliation': 'Division of Neonatology, Regional University Hospital Málaga, Málaga, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Fernández-Colomer', 'Affiliation': 'Division of Neonatology, Central University Hospital of Asturias, Oviedo, Spain.'}, {'ForeName': 'Jose Ramón', 'Initials': 'JR', 'LastName': 'Fernández-Lorenzo', 'Affiliation': 'Division of Neonatology, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kuligowski', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Loureiro', 'Affiliation': 'Division of Neonatology, University Hospital Cruces, Bilbao, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Moral-Pumarega', 'Affiliation': 'Division of Neonatology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pavón', 'Affiliation': 'Division of Neonatology, University Hospital Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Sánchez-Illana', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Tofé', 'Affiliation': 'Division of Neonatology, University Hospital Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás', 'Affiliation': 'Department of Biostatistics, Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Robles', 'Affiliation': 'Division of Neonatology, University Hospital Complex of Vigo, Vigo, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parra-Llorca', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cernada', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Martinez-Rodilla', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Lorente-Pozo', 'Affiliation': 'Health Research Institute La Fe, Valencia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'Department of Radiology, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Remedios', 'Initials': 'R', 'LastName': 'Marqués', 'Affiliation': 'Departament of Pharmacy, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Máximo', 'Initials': 'M', 'LastName': 'Vento', 'Affiliation': 'Division of Neonatology, University and Polytechnic Hospital La Fe, Valencia, Spain, maximo.vento@uv.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neonatology,['10.1159/000499084']
678,30773542,[Effect of a novel cold atmospheric plasma jet treatment with different temperatures on resin-dentin bonding].,"OBJECTIVE


To investigate the effect of different treatment temperatures of a novel cold atmospheric plasma jet treatment on the resin-dentin bonding.
METHODS


(1) Fifty-two freshly extracted, non-carious and intact third molars were collected. The occlusal one-third of the crown was removed by means of a water-cooled low-speed Isomet saw. One dentin disc [(900 ±100) μm] was prepared for each tooth. The fifty-two dentin discs were randomly divided into control group and experimental groups, of which four were in control group, and forty-eight were divided into four experimental groups according to the different treatment temperatures (4 °C, 10 °C, 20 °C and 30 °C) of the novel radio-frequency atmospheric-pressure glow discharge (RF-APGD) plasma jet, twelve in each group. Each experimental group was divided into three subgroups according to different treatment time (10 s, 20 s and 30 s), with four in each subgroup. The occlusal one-third of the crown was removed by means of a water-cooled low-speed Isomet saw. The morphology of demineralized dentin surfaces was analyzed using field emission scanning electron microscopy. (2) Twenty unerupted, non-carious and intact third molars were randomly divided into five groups, four in each group: control group, untreated; 4 °C, 10 °C, 20 °C and 30 °C experimental groups, each group was treated with the RF-APGD plasma jet for 20 s. The micro-tensile resin dentin bond strength was tested after 20 s RF-APGD plasma jet treatment with different temperatures, using a universal mechanical machine.
RESULTS


(1) The field emission scanning electron microscopy results indicated that when compared with the control group, a 10 s RF-APGD plasma jet treatment with 30 °C and 20 °C collapsed the collagen scaffold. Collagen fibrils maintained an uncollapsed three-dimensional structure after the 4 °C RF-APGD plasma jet treatment for even 30 s treatment. (2) The microtensile resin dentin bond strength results of the 4 °C RF-APGD plasma jet treatment group (57.8±0.7) MPa were significantly higher than that of the control group [(47.4±0.5) MPa] and 10 s, 20 s and 30 s RF-APGD plasma treatment group [(51.9±0.7) MPa,(29.7±1.0) MPa and (22.2±1.5) MPa] with statistically significant difference (P<0.05). Compared with the control group, the micro-tensile bond strength increased about 21.9% and 9.5% after 4 °C and 10 °C RF-APGD plasma jet treatment, respectively.
CONCLUSION


Compared with other treatment temperatures, this novel RF-APGD plasma jet treatment with the temperature of 4 °C can preserve the three-dimensional morphology of demineralized dentin better, and can improve the resin-dentin bonding.",2019,"The micro-tensile resin dentin bond strength was tested after 20 s RF-APGD plasma jet treatment with different temperatures, using a universal mechanical machine.
","['1) Fifty-two freshly extracted, non-carious and intact third molars were collected', '2) Twenty unerupted, non-carious and intact third molars', 'fifty-two dentin discs']","['novel radio-frequency atmospheric-pressure glow discharge (RF-APGD) plasma jet, twelve in each group', 'novel cold atmospheric plasma jet treatment', 'RF-APGD plasma jet for 20 s']","['microtensile resin dentin bond strength results', 'micro-tensile bond strength']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}]","[{'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004180', 'cui_str': 'Atmospheric Pressure'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1.0,0.0161786,"The micro-tensile resin dentin bond strength was tested after 20 s RF-APGD plasma jet treatment with different temperatures, using a universal mechanical machine.
","[{'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Zhu', 'Affiliation': 'Second Clinical Division, Peking University School and Hospital of Stomatology &amp; National Clinical Research Center for Oral Diseases &amp; National Engineering Laboratory for Digital and Material Technology of Stomatology &amp; Beijing Key Laboratory of Digital Stomatology, Beijing 100101, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing 100081, China.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Li', 'Affiliation': 'Second Clinical Division, Peking University School and Hospital of Stomatology &amp; National Clinical Research Center for Oral Diseases &amp; National Engineering Laboratory for Digital and Material Technology of Stomatology &amp; Beijing Key Laboratory of Digital Stomatology, Beijing 100101, China.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Zhang', 'Affiliation': 'Department of Stomatology, Aerospace Center Hospital, Beijing 100049, China.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Li', 'Affiliation': 'Department of Engineering Physics, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Tan', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,['10.19723/j.issn.1671-167X.2019.01.008']
679,31755280,Randomized clinical trial evaluating the effect of a visual educational leaflet on the preparation of colonoscopies in hospitalized patients.,"BACKGROUND


the safety and diagnostic accuracy of colonoscopies depends on the quality of colon cleansing. Several factors have been reported that affect the quality of bowel cleansing, hospitalization being one of them.
AIMS


the aim of the study was to investigate whether a visual educational leaflet improved the level of cleanliness achieved in hospitalized patients undergoing a colonoscopy and to identify predictors of a poor bowel preparation.
METHODS


a prospective, single-center, endoscopist-blinded, randomized controlled trial was performed. The intervention group was given a visual educational leaflet and both groups received four liters of polyethylene glycol solution. Demographic data, personal history, reason for admission and indication for colonoscopy, work shift during which the procedure was performed and endoscopy findings were collected. The Boston Bowel Preparation Scale (BBPS) was used to assess the bowel preparation.
RESULTS


one hundred and thirty-six patients were included in the study; 51.5% were male, with a mean age of 64.3 ± 17.6 years. The educational leaflet did not result in a difference in the total BBPS obtained between the standard group and the intervention group (7 [6-9] vs 6 [5.7-9]; p = 0.17). According to the multivariable analysis, the only factors associated with a poor bowel cleansing were heart disease (OR 3.37 [1.34-8.46]; p = 0.010) and colorectal cancer (OR 3.82 [1.26-11.61]; p = 0.018).
CONCLUSION


the use of a visual educational leaflet for the preparation of colonoscopies did not provide a significant improvement in hospitalized patients in our health area. Heart disease was identified as the only predictor of poor preparation for colonoscopy.",2019,The educational leaflet did not result in a difference in the total BBPS obtained between the standard group and the intervention group (7 [6-9] vs 6 [5.7-9]; p = 0.17).,"['hospitalized patients in our health area', 'one hundred and thirty-six patients were included in the study; 51.5% were male, with a mean age of 64.3 ± 17.6 years', 'hospitalized patients undergoing a colonoscopy and to identify predictors of a poor bowel preparation', 'hospitalized patients']","['visual educational leaflet', 'visual educational leaflet and both groups received four liters of polyethylene glycol solution']","['Boston Bowel Preparation Scale (BBPS', 'colorectal cancer', 'total BBPS', 'heart disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}]",136.0,0.101087,The educational leaflet did not result in a difference in the total BBPS obtained between the standard group and the intervention group (7 [6-9] vs 6 [5.7-9]; p = 0.17).,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Guardiola-Arévalo', 'Affiliation': 'Department of Gastroenterology. IdiPAZ, Hospital Universitario de Fuenlabrada, Española.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Granja Navacerrada', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario de Fuenlabrada, España.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'García-Alonso', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario Río Hortega, España.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Bernal Checa', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario de Fuenlabrada, España.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Piqué Becerra', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario de Fuenlabrada, España.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Guerra', 'Affiliation': 'Department of Gastroenterology.IdiPAZ, Hospital Universitario de Fuenlabrada, España.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Algaba', 'Affiliation': 'Department of Gastroenterology. IdiPAZ, Hospital Universitario de Fuenlabrada, España.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'de Andrés Esteban', 'Affiliation': 'Applied Economy Department. IdiPAZ, Universidad Rey Juan Carlos, España.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bermejo', 'Affiliation': 'Department of Gastroenterology. IdiPAZ, Hospital Universitario de Fuenlabrada, España.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2019.6317/2019']
680,31162757,The effects of bladder training on bladder functions after transurethral resection of prostate.,"AIM AND OBJECTIVES


The aim of this was to examine the effect of bladder training on bladder functions.
BACKGROUND


Urinary catheterization is frequently performed in order to evaluate the outcomes of the surgical procedures and to monitor the urine output after urology operations.
DESIGN AND METHODS


This quasi-experimental study was conducted in the urology clinic in Istanbul, Turkey in which 50 males were nonrandomly assigned to either a bladder training (n = 28) or a control group (n =22). In the bladder training groups, the urinary catheters of the patients were clamped at 4-hr intervals and then were left open for 5 min on the second postoperative day. This study was created in accordance with TREND Statement Checklist.
RESULTS


The first urgency time and the first voiding time were longer, and the prevoiding and the voiding volumes were higher following the removal of the catheter in the training group (p = 0.001). In addition, the evaluation of the patient bladder diaries in the first three days after the discharge period revealed that the daily frequencies of micturition and nocturia were lower (p = 0.04), the mean duration of intervals between the micturition was longer (p = 0.006), and the mean voided urinary volume was higher (p = 0.024) in the training group.
CONCLUSION


At the end of the study, it is observed that bladder training performed by clamping the catheter on postoperative day 2 after Transurethral Resection of Prostate (TUR-P) operation is a significant positive effect on the storage symptoms of the patients.
RELEVANCE TO CLINICAL PRACTICE


Before removing the urinary catheter, bladder training programme affects positively to patients, especially prevoiding and the voiding volumes, the daily frequencies of micturition and nocturia on postoperative periods.",2020,"The first urgency time and the first voiding time were longer, and the prevoiding and the voiding volumes were higher following the removal of the catheter in the training group (p = 0.001).","['after transurethral resection of prostate', 'urology clinic in Istanbul, Turkey in which 50 males']",['bladder training'],"['urgency time and the first voiding time', 'daily frequencies of micturition and nocturia', 'patient bladder diaries', 'mean voided urinary volume', 'mean duration of intervals between the micturition', 'bladder functions', 'voiding volumes']","[{'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}]","[{'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0232840', 'cui_str': 'Bladder function (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",50.0,0.0245313,"The first urgency time and the first voiding time were longer, and the prevoiding and the voiding volumes were higher following the removal of the catheter in the training group (p = 0.001).","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Büyükyilmaz', 'Affiliation': 'Fundamentals of Nursing Department, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Culha', 'Affiliation': 'Fundamentals of Nursing Department, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Zümreler', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Özer', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Gokhan', 'Initials': 'MG', 'LastName': 'Culha', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Ötünçtemur', 'Affiliation': 'Department of Urology, University of Health Sciences, Okmeydanı Training and Research Hospital, Istanbul, Turkey.'}]",Journal of clinical nursing,['10.1111/jocn.14939']
681,31127782,A Multidomain Intervention for Modifying Lifestyle Habits Reduces the Dementia Risk in Community-Dwelling Older Adults: A Single-Blinded Randomized Controlled Pilot Study.,"We aimed to examine the feasibility and effectiveness of a multidomain intervention including intensive and maintenance programs for reducing the risk of dementia in at-risk older adults. Community-dwelling older adults (aged ≥60 years) without dementia but having several risk factors for dementia (N = 32; 89% female; mean age±standard deviation, 76.8±4.7 years) were assigned to three parallel programs: intensive plus maintenance (INT+MNT), intensive only (INT-only), and active control. Subjects in INT+MNT and INT-only groups participated in a 4-week intensive group-based lifestyle modification program that focused on physical activity, vascular risk factors, dietary habits, cognitive activities, and social engagement. INT+MNT participants underwent an additional 20-week maintenance program to consolidate modified habits. The modified Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) score was used as the primary outcome measure for dementia risk. The changes in ANU-ADRI scores exhibited a significant group-by-time interaction: the INT+MNT group showed significant improvement at 24 weeks (β= -6.05; SE = 1.86; p = 0.002), while the INT-only group did not. Additional exploratory analyses showed that the reduction in ANU-ADRI scores was caused by changes in protective factors rather than in risk factors. The INT + MNT group also showed greater improvement in executive function at 4 and 24 weeks (both p = 0.044), whereas changes in global cognitive function did not reach significance (p = 0.055). A 24-week multidomain dementia prevention involving a maintenance strategy for sustaining modified lifestyle habits reduced the risk of dementia and improved executive function in at-risk older adults.",2019,"The INT + MNT group also showed greater improvement in executive function at 4 and 24 weeks (both p = 0.044), whereas changes in global cognitive function did not reach significance (p = 0.055).","['at-risk older adults', 'N\u200a=\u200a32; 89% female; mean age±standard deviation, 76.8±4.7 years', 'Community-dwelling older adults (aged ≥60 years) without dementia but having several risk factors for dementia ', 'Community-Dwelling Older Adults', 'dementia in at-risk older adults']","['4-week intensive group-based lifestyle modification program', 'multidomain intervention', 'Multidomain Intervention', 'intensive plus maintenance (INT+MNT), intensive only (INT-only), and active control']","['risk of dementia and improved executive function', 'Dementia Risk', ""modified Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) score"", 'ANU-ADRI scores', 'global cognitive function', 'changes in ANU-ADRI scores', 'executive function']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0209959,"The INT + MNT group also showed greater improvement in executive function at 4 and 24 weeks (both p = 0.044), whereas changes in global cognitive function did not reach significance (p = 0.055).","[{'ForeName': 'Jee Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Jeon', 'Affiliation': 'Department of Psychiatry, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Se An', 'Initials': 'SA', 'LastName': 'Kim', 'Affiliation': 'Gachon University College of Nursing, Incheon, South Korea.'}, {'ForeName': 'Jin Ha', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Siheung Community Center for Dementia, Siheung, South Korea.'}, {'ForeName': 'Seon Hwa', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Seoul Metropolitan Center for Dementia, Seoul, South Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Jongno Community Center for Dementia, Seoul, South Korea.'}, {'ForeName': 'Yun Jung', 'Initials': 'YJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Neuropsychiatry, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Gijung', 'Initials': 'G', 'LastName': 'Jung', 'Affiliation': 'Medical Research Center, Institute of Human Behavioral Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Suk', 'Affiliation': 'Department of Psychology, Sogang University, Seoul, South Korea.'}, {'ForeName': 'Saejong', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Korea Institute of Sport Science, Seoul, South Korea.'}, {'ForeName': 'Dong Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Seoul National University College of Medicine, Seoul, South Korea.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190016']
682,31755803,Impact of Laparoscopic Sleeve Gastrectomy on Obese Patients with Subclinical Hypothyroidism.,"Background:  This study aims to evaluate the incidence of subclinical hypothyroidism (SCH) among studied obese patients. The effects of laparoscopic sleeve gastrectomy (LSG) and loss of weight on thyroid hormones level and the impact of adding thyroxine treatment is described.  Patients and Methods:  Obese patients undergoing LSG at the university hospital between June 2016 and January 2018 were included. Weight loss and changes in body mass index (BMI), serum thyroid stimulating hormone (TSH), and FT4 were evaluated. SCH patients were randomly divided into group ""A"" received thyroxine treatment and group ""B"" received no treatment.  Results:  There were 554 patients studied (mean age 41 ± 12 years); the mean preoperative BMI, serum TSH, and FT4 were 45 ± 6.8 kg/m 2 , 3.91 ± 1 μU/mL, and 1.32 ± 1 ng, respectively. Incidence of SCH was 12.9%. Significant post-LSG decrease in BMI (30.8 ± 4.6 kg/m 2 ) was associated with significant decrease in serum TSH (1.99 ± 1.1 μU/mL) in all patients; changes were more prominent in SCH group and in patients with higher BMI. SCH patients had normalization of mean serum TSH at 12 months post-LSG. Results of groups ""A"" and ""B"" were not significantly different.  Conclusion:  The incidence of SCH was 12.9%. The significant decrease in BMI was associated with a significant decrease in serum TSH after LSG; this was more evident in SCH and in patients with higher BMI. Complete resolution of SCH occurred at 12 months post-LSG. Adding thyroxine treatment in obese SCH patients did not improve outcome and should be reserved to specific clinical and laboratory indications.",2020,Adding thyroxine treatment in obese SCH patients did not improve outcome and should be reserved to specific clinical and laboratory indications.,"['SCH patients', 'studied obese patients', 'Obese patients undergoing LSG at the university hospital between June 2016 and January 2018 were included', 'Obese Patients with Subclinical Hypothyroidism', '554 patients studied (mean age 41\u2009±\u200912 years', 'obese SCH patients']","['thyroxine treatment and group ""B"" received no treatment', 'laparoscopic sleeve gastrectomy (LSG', 'Laparoscopic Sleeve Gastrectomy', 'SCH', 'thyroxine']","['subclinical hypothyroidism (SCH', 'Weight loss and changes in body mass index (BMI), serum thyroid stimulating hormone (TSH), and FT4', 'serum TSH', 'Complete resolution of SCH', 'Incidence of SCH', 'normalization of mean serum TSH', 'BMI', 'incidence of SCH', 'mean preoperative BMI, serum TSH, and FT4']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",554.0,0.0368617,Adding thyroxine treatment in obese SCH patients did not improve outcome and should be reserved to specific clinical and laboratory indications.,"[{'ForeName': 'Tamer N', 'Initials': 'TN', 'LastName': 'Abdelbaki', 'Affiliation': 'General Surgery Department, Alexandria University Faculty of Medicine, Alexandria, Egypt.'}, {'ForeName': 'Mostafa R', 'Initials': 'MR', 'LastName': 'Elkeleny', 'Affiliation': 'General Surgery Department, Alexandria University Faculty of Medicine, Alexandria, Egypt.'}, {'ForeName': 'Mohamed Abdallah', 'Initials': 'MA', 'LastName': 'Sharaan', 'Affiliation': 'General Surgery Department, Alexandria University Faculty of Medicine, Alexandria, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Talha', 'Affiliation': 'General Surgery Department, Medical Research Institute, Alexandria, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Bondok', 'Affiliation': 'Internal Medicine Department, Alexandria University Faculty of Medicine, Alexandria, Egypt.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0642']
683,31146957,"Arginine, glutamine, and fish oil supplementation in cancer patients treated with concurrent chemoradiotherapy: A randomized control study.","We evaluated the effectiveness of arginine, glutamine, and fish oil supplementation in patients' ability to adhere to the planned regimen and associated toxicities in patients who received concurrent chemoradiotherapy (CCRT). Eighty-eight cancer patients were randomized into 2 groups, A; regular diet and B; regular diet plus nutritional supplementation during their CCRT course. Logistic regression was used to assess the association between toxicity and the study groups. Survival analysis was performed using the Kaplan-Meier method, and log-rank tests were used to compare between the 2 groups. Among 88 patients, 45%, 32%, and 23% were head and neck cancer, esophageal cancer, and cervical cancer patients, respectively. Significantly higher grade 3-4 hematologic toxicities were found in group A than in group B (23% vs 5%, P= 0.03). The CCRT completion rate was lower in group A than in group B (75% vs 91%), but the difference was not statistically significant (P= 0.09). Adjusted for type of cancer and age, group B patients were associated with lower hematologic toxicities of CCRT, P= 0.03. Two-year overall survival was 47% for group A, and 61% for group B, P= 0.22. In conclusion, incidence of severe hematologic toxicities were significantly lower in patients with arginine, glutamine, and fish oil supplementation during CCRT. These findings, therefore, need further studies on the isocaloric design.",2020,"Two-year overall survival was 47% for group A, and 61% for group B, P= 0.22.","['cancer patients treated with concurrent chemoradiotherapy', 'Eighty-eight cancer patients', 'patients who received concurrent chemoradiotherapy (CCRT', '88 patients, 45%, 32%, and 23% were head and neck cancer, esophageal cancer, and cervical cancer patients, respectively']","['Arginine, glutamine, and fish oil supplementation', 'arginine, glutamine, and fish oil supplementation', 'regular diet and B; regular diet plus nutritional supplementation']","['severe hematologic toxicities', 'hematologic toxicities of CCRT', 'hematologic toxicities', 'CCRT completion rate', 'overall survival']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]","[{'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",88.0,0.0267941,"Two-year overall survival was 47% for group A, and 61% for group B, P= 0.22.","[{'ForeName': 'Imjai', 'Initials': 'I', 'LastName': 'Chitapanarux', 'Affiliation': 'Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Northern Thai Research Group of Radiation Oncology (NTRG-RO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Chiang Mai Cancer Registry, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand. Electronic address: imjai@hotmail.com.'}, {'ForeName': 'Patrinee', 'Initials': 'P', 'LastName': 'Traisathit', 'Affiliation': 'Department of Statistics, Faculty of Science, Chiang Mai University, Thailand; Center of Excellence in Bioresources for Agriculture, Industry and Medicine, Faculty of Science, Chiang Mai University, Thailand.'}, {'ForeName': 'Taned', 'Initials': 'T', 'LastName': 'Chitapanarux', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Rungarun', 'Initials': 'R', 'LastName': 'Jiratrachu', 'Affiliation': 'Division of Radiation Oncology, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand.'}, {'ForeName': 'Pattawee', 'Initials': 'P', 'LastName': 'Chottaweesak', 'Affiliation': 'Radiotherapy Unit, Radiology Department, Maharat Nakhonratchasima Hospital, Nakhonratchasima, Thailand.'}, {'ForeName': 'Somvilai', 'Initials': 'S', 'LastName': 'Chakrabandhu', 'Affiliation': 'Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Northern Thai Research Group of Radiation Oncology (NTRG-RO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Withee', 'Initials': 'W', 'LastName': 'Rasio', 'Affiliation': 'Radiotherapy Unit, Radiology Department, Maharat Nakhonratchasima Hospital, Nakhonratchasima, Thailand.'}, {'ForeName': 'Veeradej', 'Initials': 'V', 'LastName': 'Pisprasert', 'Affiliation': 'Division of Nutrition, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Patumrat', 'Initials': 'P', 'LastName': 'Sripan', 'Affiliation': 'Northern Thai Research Group of Radiation Oncology (NTRG-RO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Chiang Mai Cancer Registry, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand.'}]",Current problems in cancer,['10.1016/j.currproblcancer.2019.05.005']
684,31131641,Feasibility of a randomised controlled trial to evaluate home-based virtual reality therapy in children with cerebral palsy.,"Purpose:  Evidence is increasing for effective virtual reality therapy for motor rehabilitation for children with Cerebral Palsy. We assessed the feasibility of a virtual reality therapy mode of intervention, appropriateness of measures, and potential cost-effectiveness.  Methods:  A 12-week, 2-group, parallel-feasibility trial (ISRCT 17624388) using Nintendo Wii Fit TM  at home. Children aged 5-16, with ambulatory Cerebral Palsy, who were able to follow simple instructions were randomised to two groups; one supported by physiotherapists (individualised activity programme), the other unsupported with children having free choice (control). Children were assessed in clinic at baseline, week 6, and week 12 by blinded assessors. Feasibility of the intervention was assessed via recruitment, adherence, and usefulness of measurement tools.  Results:  Forty-four children were eligible (out of 48 approached): 31 consented, 30 were randomised, 21 completed the study; 10 in the supported group and 11 in the unsupported group. Nine children discontinued from tiredness, after-school activities, homework, surgery, technical difficulties or negative system feedback. The supported group completed 19 of 36 (IQR 5-35) possible sessions; the unsupported group 24 of 36 sessions (IQR 8-36). Gross Motor Function Measure scores varied by Cerebral Palsy severity after the intervention. There were no adverse events.  Conclusion:  Virtual reality therapy offers potential as a therapeutic adjunct for children with Cerebral Palsy, warranting substantive confirmatory study. Gross Motor Function Measure, with modifications to improve sensitivity, appeared appropriate as a primary measure, with Timed up and Go test secondary. The intervention was inexpensive costing £20 per child. An explanatory trial to evaluate the clinical/cost-effectiveness of commercial system virtual reality therapy is feasible with minor methodological adaptation. Implications for rehabilitation Home-based interactive computer gaming was feasible, safe and cost effective as a therapy adjunct. Discontinue if additional pressures are present: imminent surgery, family resilience to technical difficulties, negative system feedback, after-school activities. Change in Gross Motor Function Measurement scores varied by severity of Cerebral Palsy.",2019,There were no adverse events.  ,"['children with Cerebral Palsy', 'Children aged 5-16, with ambulatory Cerebral Palsy, who were able to follow simple instructions', 'Forty-four children were eligible (out of 48 approached): 31 consented, 30 were randomised, 21 completed the study; 10 in the supported group and 11 in the unsupported group', 'children with cerebral palsy']","['Virtual reality therapy', 'commercial system virtual reality therapy', 'rehabilitation Home-based interactive computer gaming', 'Nintendo Wii Fit TM  at home', 'physiotherapists (individualised activity programme), the other unsupported with children having free choice (control', 'home-based virtual reality therapy']",['Gross Motor Function Measurement scores'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3494470', 'cui_str': 'Virtual Reality Immersion Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",44.0,0.0461797,There were no adverse events.  ,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Farr', 'Affiliation': 'a Research and Innovation , Sussex Community NHS Trust , Brighton , England.'}, {'ForeName': 'Dido', 'Initials': 'D', 'LastName': 'Green', 'Affiliation': 'c Department of Rehabilitation , Oxford Brookes University , Oxford , England.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'b Brighton and Sussex Medical School , Brighton , England.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Male', 'Affiliation': 'a Research and Innovation , Sussex Community NHS Trust , Brighton , England.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'd School of Economics , University of Surrey , Guildford , England.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'e Medical School , University of Exeter , Exeter , England.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Speller', 'Affiliation': 'a Research and Innovation , Sussex Community NHS Trust , Brighton , England.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Colville', 'Affiliation': 'f Parent partnership advisors Sussex Community NHS Trust , Brighton , England.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'f Parent partnership advisors Sussex Community NHS Trust , Brighton , England.'}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Memon', 'Affiliation': 'b Brighton and Sussex Medical School , Brighton , England.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': 'e Medical School , University of Exeter , Exeter , England.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1618400']
685,31106835,Relief of Neuropathic Pain Through Epidermal Growth Factor Receptor Inhibition: A Randomized Proof-of-Concept Trial.,"OBJECTIVE


Case reports and a case series have described relief of neuropathic pain (NP) after treatment with epidermal growth factor receptor inhibitors (EGFR-Is). These observations are supported by preclinical findings. The aim of this trial was to explore a potential clinical signal supporting the therapeutic efficacy of EGFR-Is in NP.
METHODS


In a proof-of-concept trial using a randomized, double-blind, placebo-controlled design, 14 patients with severe, chronic, therapy-resistant NP due to compressed peripheral nerves or complex regional pain syndrome were randomized to receive a single infusion of the EGFR-I cetuximab and placebo in crossover design, followed by a single open-label cetuximab infusion.
RESULTS


The mean reduction in daily average pain scores three to seven days after single-blinded cetuximab infusion was 1.73 points (90% confidence interval [CI] = 0.80 to 2.66), conferring a 1.22-point greater reduction than placebo (90% CI = -0.10 to 2.54). Exploratory analyses suggested that pain reduction might be greater in the 14 days after treatment with blinded cetuximab than after placebo. The proportion of patients who reported ≥50% reduction in average pain three to seven days after cetuximab was 36% (14% after placebo), and comparison of overall pain reduction suggests a trend in favor of cetuximab. Skin rash (grade 1-2) was the most frequent side effect (12/14, 86%).
CONCLUSIONS


This small proof-of-concept evaluation of an EGFR-I against NP did not provide statistical evidence of efficacy. However, substantial reductions in pain were reported, and confidence intervals do not rule out a clinically meaningful treatment effect. Evaluation of EGFR-I against NP therefore warrants further investigation.",2019,"The mean reduction in daily average pain scores three to seven days after single-blinded cetuximab infusion was 1.73 points (90% confidence interval [CI] = 0.80 to 2.66), conferring a 1.22-point greater reduction than placebo (90% CI = -0.10 to 2.54).","['14 patients with severe, chronic, therapy-resistant NP due to compressed peripheral nerves or complex regional pain syndrome']","['EGFR-I cetuximab and placebo', 'placebo']","['pain', 'pain reduction', 'average pain', 'mean reduction in daily average pain scores', 'overall pain reduction', 'Skin rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332260', 'cui_str': 'Compressing (qualifier value)'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0458219', 'cui_str': 'CRPS (Complex Regional Pain Syndromes)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",14.0,0.609771,"The mean reduction in daily average pain scores three to seven days after single-blinded cetuximab infusion was 1.73 points (90% confidence interval [CI] = 0.80 to 2.66), conferring a 1.22-point greater reduction than placebo (90% CI = -0.10 to 2.54).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kersten', 'Affiliation': 'Sørlandet Hospital, Center for Cancer Treatment, Kristiansand, Norway.'}, {'ForeName': 'Marte G', 'Initials': 'MG', 'LastName': 'Cameron', 'Affiliation': 'Sørlandet Hospital, Center for Cancer Treatment, Kristiansand, Norway.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bailey', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kingussie, Scotland.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Fallon', 'Affiliation': 'Edinburgh Cancer Research Centre.'}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Laird', 'Affiliation': 'Edinburgh Cancer Research Centre.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Paterson', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kingussie, Scotland.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Mitchell', 'Affiliation': 'Centre for Discovery Brain Sciences, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Fleetwood-Walker', 'Affiliation': 'Centre for Discovery Brain Sciences, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Daly', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kingussie, Scotland.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Mjåland', 'Affiliation': 'Sørlandet Hospital, Center for Cancer Treatment, Kristiansand, Norway.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz101']
686,31009765,Oxytocin Effects on Pain Perception and Pain Anticipation.,"There is an ongoing debate whether the neuropeptide oxytocin (OT) modulates pain processing in humans. This study differentiates behavioral and neuronal OT effects on pain perception and pain anticipation by using a Pavlovian conditioning paradigm. Forty-six males received intranasally administered OT in a randomized, double-blind, placebo-controlled group design. Although OT exerted no direct effect on perceived pain, OT was found to modulate the blood oxygen level-dependent response in the ventral striatum for painful versus warm unconditioned stimuli and to decrease activity in the anterior insula (IS) with repeated thermal pain stimuli. Regarding pain anticipation, OT increased responses to CS pain  versus CS minus  in the nucleus accumbens. Furthermore, in the OT condition increased correct expectations, particularly for the most certain conditioned stimuli (CS)-unconditioned stimuli associations (CS minus  and CS pain ) were found, as well as greatest deactivations in the right posterior IS in response to the least certain condition (CS warm ) with posterior IS activity and correct expectancies being positively correlated. In conclusion, OT seems to have both a direct effect on pain processing via the ventral striatum and by inducing habituation in the anterior IS as well as on pain anticipation by boostering associative learning in general and the neuronal conditioned fear of pain response in particular. PERSPECTIVE: The neuropeptide OT has recently raised the hope to offer a novel avenue for modulating pain experience. This study found OT to modulate pain processing and to facilitate the anticipation of pain, inspiring further research on OT effects on the affective dimension of the pain experience.",2019,"Although OT exerted no direct effect on perceived pain, OT was found to modulate the blood oxygen level-dependent response in the ventral striatum for painful versus warm unconditioned stimuli and to decrease activity in the anterior insula (IS) with repeated thermal pain stimuli.","['humans', 'Forty-six males received']","['neuropeptide oxytocin (OT', 'intranasally administered OT', 'placebo', 'Oxytocin']","['Pain Perception and Pain Anticipation', 'blood oxygen level', 'pain perception and pain anticipation']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",46.0,0.0466066,"Although OT exerted no direct effect on perceived pain, OT was found to modulate the blood oxygen level-dependent response in the ventral striatum for painful versus warm unconditioned stimuli and to decrease activity in the anterior insula (IS) with repeated thermal pain stimuli.","[{'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Herpertz', 'Affiliation': 'Department of General Psychiatry, University Hospital of Heidelberg, Heidelberg, Germany. Electronic address: sabine.herpertz@uni-heidelberg.de.'}, {'ForeName': 'Mike M', 'Initials': 'MM', 'LastName': 'Schmitgen', 'Affiliation': 'Department of General Psychiatry, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fuchs', 'Affiliation': 'Department of General Psychiatry, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Roth', 'Affiliation': 'Department of General Psychiatry, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Robert Christian', 'Initials': 'RC', 'LastName': 'Wolf', 'Affiliation': 'Department of General Psychiatry, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department of General Psychiatry, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Herta', 'Initials': 'H', 'LastName': 'Flor', 'Affiliation': 'Institute of Cognitive and Clinical Neuroscience, Central Institute of Mental Health Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Grinevich', 'Affiliation': 'Schaller Research Group on Neuropeptides, German Cancer Research Center DKFZ, Heidelberg, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Boll', 'Affiliation': 'Department of General Psychiatry, University Hospital of Heidelberg, Heidelberg, Germany.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.04.002']
687,31943055,Nutrition Intervention Using Behavioral Change Communication without Additional Material Inputs Increased Expenditures on Key Food Groups in Bangladesh.,"BACKGROUND


Behavioral change communication (BCC) promotes skills and knowledge to improve infant and young child feeding, but without additional material inputs, recipients must develop strategies to translate knowledge into action. Using data from the Alive & Thrive initiative in Bangladesh (2010-2014), we aimed to test whether households receiving the intensive intervention (opposed to the nonintensive intervention) increased expenditures on key foods for mothers and children (e.g., foods that were promoted by the intervention and also changed in maternal and child diets).
METHODS


The intensive intervention provided interpersonal counseling, community mobilization, and mass media campaigns to promote breastfeeding and complementary feeding. A cluster-randomized design compared 20 subdistricts randomly assigned to the intensive (4281 households) or nonintensive (4284 households) intervention. Measures included food and nonfood expenditures, dietary diversity, and women's economic resources. Linear and logistic regression tested difference-in-differences (DD) in expenditures and dietary diversity, accounting for subdistricts as clusters, and the association between maternal and child consumption of specific food groups and corresponding food expenditures.
RESULTS


Expenditures on eggs and flesh foods increased more in intensive areas than in nonintensive areas by 53 (P < 0.01) and 471 (P < 0.01) taka/mo, respectively. Household food expenditures increased more in intensive areas by 832 taka (P = 0.02), whereas changes in nonfood expenditures did not differ. Women's employment and control of income increased more in intensive areas by 12 (P = 0.03) and 13 (P < 0.01) percentage points, respectively, while jewelry ownership decreased more by 23 percentage points (P < 0.01). Higher expenditures on food groups were reflected in higher consumption by women and children.
CONCLUSIONS


Recipients in the intensive intervention mobilized additional resources to improve diets, reflected in increased expenditures and consumption of promoted foods. BCC interventions should document how recipients produce desired results without additional material inputs, particularly for behaviors that likely require additional resources. This trial was registered at clinicaltrials.gov as NCT01678716.",2020,"Household food expenditures increased more in intensive areas by 832 taka (P = 0.02), whereas changes in nonfood expenditures did not differ.","['Bangladesh', '20\xa0subdistricts randomly assigned to the intensive (4281 households) or nonintensive (4284 households) intervention']","['Behavioral change communication (BCC', 'Nutrition Intervention', 'intensive intervention provided interpersonal counseling, community mobilization, and mass media campaigns to promote breastfeeding and complementary feeding', 'intensive intervention (opposed to the nonintensive intervention) increased expenditures on key foods']","['Household food expenditures', 'nonfood expenditures', 'expenditures and consumption of promoted foods', ""food and nonfood expenditures, dietary diversity, and women's economic resources"", 'Expenditures on eggs and flesh foods']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0024869', 'cui_str': 'Mass Media'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}]",,0.0420495,"Household food expenditures increased more in intensive areas by 832 taka (P = 0.02), whereas changes in nonfood expenditures did not differ.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Warren', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Phuong H', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Menon', 'Affiliation': 'Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, DC, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz339']
688,30773553,[Preliminary clinical application of complete digital workflow of design and manufacturing occlusal splint for sleep bruxism].,"OBJECTIVE


To establish a complete workflow of digital design and manufacturing occlusal splint for sleep bruxism, which can be preliminarily applied in clinical use, thus observe the clinical efficacy.
METHODS


Twenty-four patients with sleep bruxism were recruited in the study and randomly divided into two groups by using random number tables. Digital-occlusal-splint (experimental group) treatment plan and traditional-occlusal-splint (control-group) treatment plan were carried out for each group, respectively. For experimental group, digital models of patients' both dental arches and the occlusion relationship after elevation were captured using an intraoral scanner. The occlusal splint was carried out by computer aided design/computer aided manufacturing (CAD/CAM), including splint designing and milling. For control group, the traditional soft occlusal splint was fabricated by vacuum laminator. The two kinds of occlusal splints were tried in the patients from each group, and the occlusal contacts were tested respectively by T-scan analysis system, which recorded the changes of occlusal indicators in the two groups. The retention, appearance and occlusal comfort degree were evaluated by the two groups of patients. Mann-Whitney test was performed with IBM SPSS 20.0 software, and bilateral test was performed. P<0.05 was considered to be statistically significant.
RESULTS


The complete workflow of digital design and manufacturing occlusal splint was successfully established. During the clinical use, there was no statistical difference in the retention evaluation of two kinds of occlusal splints between the two groups of patients (Z=-0.538, P=0.590). The appearance score (Z=2.038, P=0.042) and the occlusal comfort score (Z=-2.579, P=0.010) of the experimental group were higher than those of the control group, with statistically significant differences. The T-scan analysis results showed that only the second molar on both sides of the traditional occlusal splint had occlusal contact in intercupsal position, while the digital occlusal splint had stable and bilaterally balanced contact between the maxillary and mandibular teeth. Furthermore, the occlusal force was uniformly distributed in the experimental group.
CONCLUSION


The complete workflow of digital occlusal splint improves the occlusal design, greatly simplifies and optimizes the traditional process of making occlusal splint. This new method is resource-saving and environmental-friendly, and it is able to serve patients more conveniently and efficiently.",2019,"During the clinical use, there was no statistical difference in the retention evaluation of two kinds of occlusal splints between the two groups of patients (Z=-0.538, P=0.590).",['Twenty-four patients with sleep bruxism'],"['complete digital workflow of design and manufacturing occlusal splint', 'Digital-occlusal-splint (experimental group) treatment plan and traditional-occlusal-splint (control-group) treatment plan']","['appearance score', 'occlusal comfort score', 'occlusal force', 'retention, appearance and occlusal comfort degree']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751771', 'cui_str': 'Bruxism, Nocturnal'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0162528', 'cui_str': 'Occlusal Splints'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",24.0,0.0177803,"During the clinical use, there was no statistical difference in the retention evaluation of two kinds of occlusal splints between the two groups of patients (Z=-0.538, P=0.590).","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'H Q', 'Initials': 'HQ', 'LastName': 'Ye', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tong', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Gao', 'Affiliation': 'Dental Laboratory, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Zhou', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,['10.19723/j.issn.1671-167X.2019.01.019']
689,31870394,"Effect of a community-based intervention for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: study protocol for a cluster randomised controlled trial.","BACKGROUND


Stroke has emerged as a leading cause of death in rural India. However, well-tested healthcare interventions to reduce stroke mortality in rural under-resourced settings are lacking. The aim of this study is to evaluate the effect of a community-based preventive intervention on stroke mortality in rural Gadchiroli, India.
METHODS


The study is a two-arm, parallel group, cluster randomised controlled trial in which 32 villages will be randomised to the intervention and the enhanced usual care (EUC) arm. In the intervention arm, individuals ≥50 years of age will be screened for hypertension, diabetes and stroke by trained Community Health Workers (CHWs). Screened individuals who are positive will be referred to a mobile outreach clinic which will visit the intervention villages periodically. A physician in the clinic will confirm the diagnosis, provide guideline-based treatment and follow up patients. The CHWs will make home visits once a month to ensure medication compliance and counsel patients to reduce salt consumption and quit tobacco and alcohol. In the EUC arm, households will be provided information on the ill effects of tobacco use and steps to quit it. Individuals from both the arms will have access to the government's national programme for the prevention and control of non-communicable diseases, where treatment for hypertension, diabetes and preventive treatment after stroke is available at the nearest primary health centres (PHCs). The intervention will be implemented for 3.5 years. The primary outcome will be a reduction in stroke mortality in the last 2.5 years of the intervention.
DISCUSSION


This trial will provide important information regarding the feasibility and effect of a community-based preventive intervention package on stroke mortality in a rural under-resourced setting and can inform India's non-communicable diseases prevention and control programme. If successful, such an intervention can be scaled up in the rural regions of India and other countries.
TRIAL REGISTRATION


Clinical Trials Registry of India: CTRI/2015/12/006424. Registered on 8 December 2015.",2019,"Individuals from both the arms will have access to the government's national programme for the prevention and control of non-communicable diseases, where treatment for hypertension, diabetes and preventive treatment after stroke is available at the nearest primary health centres (PHCs).","['Screened individuals who are positive will be referred to a mobile outreach clinic which will visit the intervention villages\xa0periodically', 'rural Gadchiroli, India', 'individuals ≥50\u2009years of age will be screened for hypertension, diabetes and stroke by trained Community Health Workers (CHWs', '32 villages']","['community-based preventive intervention package', 'community-based intervention', 'community-based preventive intervention']",['stroke mortality'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0581047', 'cui_str': 'Outreach clinic (environment)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C1704710', 'cui_str': 'Package'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.141726,"Individuals from both the arms will have access to the government's national programme for the prevention and control of non-communicable diseases, where treatment for hypertension, diabetes and preventive treatment after stroke is available at the nearest primary health centres (PHCs).","[{'ForeName': 'Yogeshwar', 'Initials': 'Y', 'LastName': 'Kalkonde', 'Affiliation': 'Society for Education, Action and Research in Community Health (SEARCH), Shodhgram, Post-Chatgaon, Taluka-Dhanora, District-Gadchiroli, Maharashtra, 442605, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Deshmukh', 'Affiliation': 'Society for Education, Action and Research in Community Health (SEARCH), Shodhgram, Post-Chatgaon, Taluka-Dhanora, District-Gadchiroli, Maharashtra, 442605, India.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Nila', 'Affiliation': 'Society for Education, Action and Research in Community Health (SEARCH), Shodhgram, Post-Chatgaon, Taluka-Dhanora, District-Gadchiroli, Maharashtra, 442605, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Jadhao', 'Affiliation': ''}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Bang', 'Affiliation': 'Society for Education, Action and Research in Community Health (SEARCH), Shodhgram, Post-Chatgaon, Taluka-Dhanora, District-Gadchiroli, Maharashtra, 442605, India. search.gad@gmail.com.'}]",Trials,['10.1186/s13063-019-3870-x']
690,31161592,Delivering Personalized Protective Behavioral Drinking Strategies via a Smartphone Intervention: a Pilot Study.,"BACKGROUND


Smartphone-based interventions are a potentially effective way to minimize alcohol-related harm in young adult, non-dependent drinkers. This pilot study is the first to evaluate the benefits and feasibility of a personalized alcohol harm-minimization intervention delivered via smartphones.
METHODS


Within a single-blind, randomized controlled design, 45 young adults were randomly assigned to either the intervention app (n = 25; 18 females; M age  = 21.36 years, SD age  = 4.15 years) or the control app (n = 20; 18 females; M age  = 22.75; SD age  = 4.41). The two primary outcomes were frequency of risky drinking and drinking-related harms, and the secondary outcome was frequency of protective behavioral strategies (PBS) use. All outcomes were measured at baseline and immediately post-intervention. Using the Enlight framework [1], usability was evaluated via structured one-on-one phone interviews with a subgroup of six participants from the intervention group (3 females; M age  = 19.5 years, SD age  = 1.64).
RESULTS


There was no significant reduction in the primary outcomes from baseline to post-intervention across the groups. For the secondary outcome, the application of PBS within drinking contexts increased at follow-up for those in the intervention group but not for control participants. End-users rated the app as highly usable but had some concerns with repetition of the app-recommended strategies.
CONCLUSIONS


This intervention, designed to reduce risky drinking behaviors among young adults, was rated as highly usable and was shown to increase the application of harm minimization strategies within drinking contexts. While the intervention and its delivery show promise, it did not appear to mitigate risky drinking behaviors. Implications of this research and future directions are discussed.
TRIAL REGISTRATION


This trial is registered at the Australian New Zealand Clinical Trials Registry: BLINDED.",2019,"For the secondary outcome, the application of PBS within drinking contexts increased at follow-up for those in the intervention group but not for control participants.","['45 young adults', 'n\u2009=\u200925; 18 females; M age \u2009=\u200921.36\xa0years, SD age \u2009=\u20094.15\xa0years) or the control app (n\u2009=\u200920; 18 females; M age \u2009=\u200922.75; SD age \u2009=\u20094.41', 'young adults']","['personalized alcohol harm-minimization intervention', 'intervention app']","['application of PBS within drinking contexts', 'risky drinking behaviors', 'frequency of risky drinking and drinking-related harms, and the secondary outcome was frequency of protective behavioral strategies (PBS) use']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}]","[{'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",45.0,0.113008,"For the secondary outcome, the application of PBS within drinking contexts increased at follow-up for those in the intervention group but not for control participants.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': ""O'Donnell"", 'Affiliation': 'Faculty of Health, School of Psychology, Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'The Cairnmillar Institute, Melbourne, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Faculty of Health, School of Psychology, Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125, Australia.'}, {'ForeName': 'Petra K', 'Initials': 'PK', 'LastName': 'Staiger', 'Affiliation': 'Faculty of Health, School of Psychology, Deakin University, 221 Burwood Highway, Burwood, Victoria, 3125, Australia. petra.staiger@deakin.edu.au.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09789-0']
691,31748836,Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX).,"PURPOSE


Sepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis.
METHODS


We undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU.
RESULTS


Patients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO 2  ≥ 97% (23.5 h [interquartile range (IQR) 8-70] vs. 47 h [IQR 11-93], absolute difference, 23 h; 95% CI 8-38), and more time receiving an FiO 2  of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1-79] vs. 0 h [IQR 0-10], absolute difference, 20 h; 95% CI 14-26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy.
CONCLUSIONS


Point estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group.
CLINICAL TRIALS REGISTRY


ICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.",2020,"At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis).","['patients with sepsis', 'Patients with sepsis allocated to', 'ICU patients', 'mechanically ventilated adults with sepsis', '251 patients with sepsis enrolled in a trial that compared', '1000 mechanically ventilated ICU patients']","['oxygen therapy (ICU-ROX', 'conservative oxygen therapy', 'usual oxygen therapy', 'Conservative oxygen therapy', 'conservative oxygen therapy with usual oxygen therapy']","['cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",1000.0,0.413117,"At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI - 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Division of Critical Care and Trauma, The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-019-05857-x']
692,31050161,Effect of liraglutide on estimates of lipolysis and lipid oxidation in obese patients with stable coronary artery disease and newly diagnosed type 2 diabetes: A randomized trial.,"Elevated levels of non-esterified fatty acids (NEFA) play a role in insulin resistance, impaired beta-cell function and they are a denominator of the abnormal atherogenic lipid profile that characterizes obese patients with type 2 diabetes (T2DM). We hypothesized that the GLP-1 receptor agonist liraglutide, in combination with metformin, would reduce lipolysis. In a randomized, double-blind, placebo-controlled, cross-over trial, 41 T2DM patients with coronary artery disease were randomized and treated with liraglutide-metformin vs placebo-metformin during 12- + 12-week periods with a wash-out period of at least 2 weeks before and between the intervention periods. NEFA kinetics were estimated using the Boston Minimal Model of NEFA metabolism, with plasma NEFA and glucose levels measured during a standard 180-minute frequently sampled intravenous glucose tolerance test. Liraglutide-metformin reduced estimates of lipolysis. Furthermore, placebo-metformin increased estimates of lipid oxidation, while treatment with liraglutide eliminated this effect. We conclude that liraglutide exerts a clinically relevant reduction in estimates of lipolysis and lipid oxidation which is explained, in part, by improved insulin secretion, as revealed by an intravenous glucose tolerance test.",2019,"Furthermore, placebo-metformin increased estimates of lipid oxidation, while treatment with liraglutide eliminated this effect.","['obese patients with stable coronary artery disease and newly diagnosed type 2 diabetes', 'obese patients with type 2 diabetes (T2DM', '41 T2DM patients with coronary artery disease']","['placebo', 'metformin', 'liraglutide', 'placebo-metformin', 'liraglutide-metformin vs placebo-metformin', 'GLP-1 receptor agonist liraglutide', 'Liraglutide-metformin']","['lipolysis and lipid oxidation', 'lipid oxidation', 'NEFA kinetics', 'lipolysis', 'plasma NEFA and glucose levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",41.0,0.11065,"Furthermore, placebo-metformin increased estimates of lipid oxidation, while treatment with liraglutide eliminated this effect.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Anholm', 'Affiliation': 'Department of Internal Medicine, Copenhagen University Hospital, Glostrup, Denmark.'}, {'ForeName': 'Preman', 'Initials': 'P', 'LastName': 'Kumarathurai', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Amirsalar', 'Initials': 'A', 'LastName': 'Samkani', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Lene R', 'Initials': 'LR', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Boston', 'Affiliation': ""Departments of Medicine, St. Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Olav W', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Ole P', 'Initials': 'OP', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Department of Internal Medicine, Copenhagen University Hospital, Amager, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13761']
693,31744023,"Use of extubation bundle including modified spontaneous breathing trial (SBT) to reduce the rate of reintubation, among preterm neonates ≤ 30 weeks.","BACKGROUND


Respiratory support in the form of mechanical ventilation is a crucial intervention in premature neonates, with respiratory problems. However, prolonged mechanical ventilation and endotracheal intubation may be associated with major adverse effects. The ideal time for extubation is based on clinical and laboratory parameters assessed at the time of planned extubation. However, such parameters are not very objective, which makes extubation in NICUs a trial-and-error approach.
OBJECTIVE


This work was done to assess the use of extubation bundle including modified spontaneous breathing trial (SBT) (10 minutes) to reduce the rate of reintubation, among preterm neonates≤30 weeks who were mechanically ventilated and extubated to non-invasive ventilation in the NICU, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.
METHODS


A prospective study based on the collection of data regarding preterm neonates≤30 weeks gestation admitted to the NICU, Women's Wellness and Research Center (WWRC), from January, 2015 to December, 2017, who were subjected to mechanical ventilation (MV) and extubation. When the clinical team decides a newborn is ready for extubation based on the extubation bundle, a modified SBT (10 min) is used.
RESULTS


This study included 465 premature babies from 24-≤30 weeks recruited in the NICU, Women's Wellness and Research Center (WWRC). Extubation bundle with modified SBT was able to predict success of extubation with 95% sensitivity and 90.4% Positive Predictive Value (PPV) in the gestational age (GA) group 24 -≤27 weeks (245) and 95.3% sensitivity and 90% PPV in the GA group > 27 -≤30 weeks (220). As expected, successfully extubated babies had a higher GA and weighed more at extubation, compared to babies who required re-intubation.
CONCLUSION


We recommend the extubation bundle with modified SBT prior to elective extubation to be used in predicting successful extubation in premature babies. Guidelines for extubation among premature babies are needed in order to reduce unnecessary exposure to adverse effects of mechanical ventilation.",2020,Extubation bundle with modified SBT was able to predict success of extubation with 95% sensitivity and 90.4% Positive Predictive Value (PPV) in the gestational age (GA) group 24 -≤27 weeks (245) and 95.3% sensitivity and 90% PPV in the GA group ,"[""465 premature babies from 24-≤30 weeks recruited in the NICU, Women's Wellness and Research Center (WWRC"", 'premature neonates, with respiratory problems', 'premature babies', ""preterm neonates≤30 weeks gestation admitted to the NICU, Women's Wellness and Research Center (WWRC), from January, 2015 to December, 2017, who were subjected to mechanical ventilation (MV) and extubation"", ""preterm neonates≤30 weeks who were mechanically ventilated and extubated to non-invasive ventilation in the NICU, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar""]",['extubation bundle including modified spontaneous breathing trial (SBT'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0034366', 'cui_str': 'State of Qatar'}]","[{'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}]",[],465.0,0.114968,Extubation bundle with modified SBT was able to predict success of extubation with 95% sensitivity and 90.4% Positive Predictive Value (PPV) in the gestational age (GA) group 24 -≤27 weeks (245) and 95.3% sensitivity and 90% PPV in the GA group ,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eissa', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Al Rifai', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdelmaaboud', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Eldakrouri', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pastoral', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Furigay', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Girish', 'Affiliation': ""Neonatal Intensive Care Unit, Women's Wellness and Research Center (WWRC), Hamad Medical Corporation (HMC), Doha, Qatar.""}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-190236']
694,31746642,Scandcleft Project Trial 2-Comparison of Speech Outcome in 1- and 2-Stage Palatal Closure in 5-Year-Olds With UCLP.,"OBJECTIVE


To investigate in-depth speech results in the Scandcleft Trial 2 with comparisons between surgical protocols and centers and with benchmarks from peers without cleft palate.
DESIGN


A prospective randomized clinical trial.
SETTING


Two Swedish and one Finnish Cleft Palate center.
PARTICIPANTS


One hundred twelve participants were 5-years-old born with unilateral cleft lip and palate randomized to either lip repair and soft palate closure at 4 months and hard palate closure at 12 months or lip repair at 3 to 4 months (Arm A), or a closure of both the soft and hard palate at 12 months (Arm C).
MAIN OUTCOME MEASURES


A composite measure dichotomized into velopharyngeal competency (VPC) or velopharyngeal incompetency (VPI), overall assessment of velopharyngeal function (VPC-Rate), percentage of consonants correct (PCC score), and consonant errors. In addition, number of speech therapy visits, average hearing thresholds, and secondary surgeries were documented to assess burden of treatment.
RESULTS


Across the trial, 53.5% demonstrated VPC and 46.5% VPI with no significant differences between arms or centers. In total, 27% reached age-appropriate PCC scores with no statistically significant difference between the arms. The Finnish center had significantly higher PCC scores, the Swedish centers had higher percentages of oral consonant errors. Number of speech therapy visits was significantly higher in the Finnish center.
CONCLUSION


At age 5, poor speech outcomes with some differences between participating centers were seen but could not be attributed to surgical protocol. As one center had very few participants, the results from that center should be interpreted with caution.",2020,"The Finnish center had significantly higher PCC scores, the Swedish centers had higher percentages of oral consonant errors.","['5-Year-Olds With UCLP', 'Two Swedish and one Finnish Cleft Palate center', 'One hundred twelve participants were 5-years-old born with unilateral cleft lip and palate randomized to either']",['lip repair and soft palate closure at 4 months and hard palate closure at 12 months or lip repair'],"['number of speech therapy visits, average hearing thresholds, and secondary surgeries', 'age-appropriate PCC scores', 'oral consonant errors', 'velopharyngeal competency (VPC) or velopharyngeal incompetency (VPI), overall assessment of velopharyngeal function (VPC-Rate), percentage of consonants correct (PCC score), and consonant errors', 'Number of speech therapy visits', 'PCC scores']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}]","[{'cui': 'C0192038', 'cui_str': 'Repair of lip (procedure)'}, {'cui': 'C0030219', 'cui_str': 'Velum Palatinum'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0037831', 'cui_str': 'Speech Therapy'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",112.0,0.121846,"The Finnish center had significantly higher PCC scores, the Swedish centers had higher percentages of oral consonant errors.","[{'ForeName': 'Inger Lundeborg', 'Initials': 'IL', 'LastName': 'Hammarström', 'Affiliation': 'Division of Speech and Language Pathology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Nyberg', 'Affiliation': 'Stockholm Craniofacial Team, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Alaluusua', 'Affiliation': 'Cleft Palate and Craniofacial Center, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Rautio', 'Affiliation': 'Cleft Palate and Craniofacial Center, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Neovius', 'Affiliation': 'Stockholm Craniofacial Team, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Berggren', 'Affiliation': 'Department of Plastic Surgery, University Hospital, Linköping, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Persson', 'Affiliation': 'Speech and Language Pathology Unit, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lohmander', 'Affiliation': 'Division of Speech and Language Pathology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619888316']
695,30722059,"Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.","BACKGROUND


Lefamulin, a pleuromutilin antibiotic, is active against pathogens commonly causing community-acquired bacterial pneumonia (CABP). The Lefamulin Evaluation Against Pneumonia (LEAP 1) study was a global noninferiority trial to evaluate the efficacy and safety of lefamulin for the treatment of CABP.
METHODS


In this double-blind study, adults with CABP of Pneumonia Outcomes Research Team risk class ≥III were randomized 1:1 to receive lefamulin at 150 mg intravenously (IV) every 12 hours or moxifloxacin at 400 mg IV every 24 hours. After 6 doses, patients could be switched to an oral study drug if prespecified improvement criteria were met. If methicillin-resistant Staphylococcus aureus was suspected, either linezolid or placebo was added to moxifloxacin or lefamulin, respectively. The US Food and Drug Administration primary endpoint was an early clinical response (ECR) 96 ± 24 hours after the first dose of the study drug in the intent-to-treat (ITT) population (noninferiority margin, 12.5%). The European Medicines Agency co-primary endpoints were an investigator assessment of clinical response (IACR) 5-10 days after the last dose of the study drug in the modified ITT (mITT) and clinically evaluable (CE) populations (noninferiority margin, 10%).
RESULTS


There were 551 patients randomized (n = 276 lefamulin; n = 275 moxifloxacin). Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%, respectively; difference -2.9%, 95% confidence interval [CI] g -8.5 to 2.8) and IACR (mITT, 81.7% vs 84.2%, respectively; difference -2.6%, 95% CI -8.9 to 3.9; CE, 86.9% vs 89.4%, respectively; difference -2.5%, 95% CI -8.4 to 3.4). Rates of study drug discontinuation due to treatment-emergent adverse events were 2.9% for lefamulin and 4.4% for moxifloxacin.
CONCLUSIONS


Lefamulin was noninferior to moxifloxacin for the primary efficacy endpoints and was generally safe and well tolerated.
CLINICAL TRIALS REGISTRATION


NCT02559310.",2019,Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%; difference:,"['Community-Acquired Bacterial Pneumonia', '551 patients were randomized (n=276 lefamulin; n=275', 'adults with CABP of Pneumonia Outcomes Research Team risk class ≥III']","['linezolid or placebo', 'moxifloxacin', 'lefamulin', 'IV-to-Oral Lefamulin, a Pleuromutilin Antibiotic', 'lefamulin 150 mg intravenously (IV) q12h or moxifloxacin 400 mg IV q24h']","['Efficacy and Safety', 'safe and well tolerated', 'early clinical response (ECR', 'investigator assessment of clinical response (IACR']","[{'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0004626', 'cui_str': 'Pneumonia, Bacterial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0035168'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0071283', 'cui_str': 'pleuromutilin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",551.0,0.472496,Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%; difference:,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'File', 'Affiliation': 'Summa Health, Akron, Ohio.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goldberg', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Das Consulting, Guerneville, California.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saviski', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Gelone', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Seltzer', 'Affiliation': 'Urogen Pharma, New York.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Paukner', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'Wolfgang W', 'Initials': 'WW', 'LastName': 'Wicha', 'Affiliation': 'Nabriva Therapeutics GmbH, Vienna, Austria.'}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Talbot', 'Affiliation': 'Talbot Advisors LLC, Anna Maria, Florida.'}, {'ForeName': 'Leanne B', 'Initials': 'LB', 'LastName': 'Gasink', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz090']
696,31088728,Incremental risk of cardiovascular disease and/or chronic kidney disease for future ASCVD and mortality in patients with type 2 diabetes mellitus: ACCORD trial.,"BACKGROUND


Cardiovascular disease (CVD) and chronic kidney disease (CKD) are complications of type 2 diabetes mellitus (DM). Current cholesterol guidelines recommend the same prevention strategy for patients with DM alone as patients with DM + CKD. However, the incremental risk of these common complications for incident cardiovascular disease and mortality has not been well studied.
METHODS


We compared the incremental risk of having DM + CKD, DM + CVD and DM + CVD + CKD in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial participants for incident CVD as the primary outcome and all-cause mortality.
RESULTS


After a mean (SD) follow up of 4.7(1.4) years, 1,046(10%) participants developed CVD. DM +vCKD, DM + CVD, and DM + CKD + CVD had a significantly increased risk of the primary outcome compared to DM alone [adjusted hazard ratio(95%CI): 1.41 (1.06-1.89), p = 0.02; 2.20 (1.92-2.53), p < 0.001); 2.35 (1.81-3.04), p < 0.001), respectively]. All-cause mortality had a graded increased risk compared to the reference group [adjusted hazard ratio(95%CI): 1.39 (1.01-1.90), p = 0.04; 1.29 (1.51-2.12), p < 0.0001; 2.36 (1.75-3.13), p < 0.0001), respectively].
CONCLUSION


Our post hoc analysis shows an incremental graded risk for CVD outcomes and all-cause mortality with the development of CKD and/or CVD in individuals with DM.",2019,"All-cause mortality had a graded increased risk compared to the reference group [adjusted hazard ratio(95%CI): 1.39 (1.01-1.90), p = 0.04; 1.29 (1.51-2.12), p < 0.0001; 2.36 (1.75-3.13), p < 0.0001), respectively].
","['individuals with DM', 'patients with DM alone as patients with DM\u202f+\u202fCKD', 'patients with type 2 diabetes mellitus']",[],['CVD'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],[],,0.426223,"All-cause mortality had a graded increased risk compared to the reference group [adjusted hazard ratio(95%CI): 1.39 (1.01-1.90), p = 0.04; 1.29 (1.51-2.12), p < 0.0001; 2.36 (1.75-3.13), p < 0.0001), respectively].
","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Branch', 'Affiliation': 'Heart and Vascular Center of Excellence, Wake Forest Baptist Health, Winston Salem, NC, United States of America. Electronic address: mbranch@wakehealth.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'German', 'Affiliation': 'Heart and Vascular Center of Excellence, Wake Forest Baptist Health, Winston Salem, NC, United States of America.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Public Health, Wake Forest Baptist Health, Winston Salem, NC, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Yeboah', 'Affiliation': 'Heart and Vascular Center of Excellence, Wake Forest Baptist Health, Winston Salem, NC, United States of America.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.04.004']
697,31156013,Seizure Action Plans for Pediatric Patients With Epilepsy: A Randomized Controlled Trial.,"OBJECTIVES


Seizure action plans help patients and caregivers better self-manage their epilepsy. We hypothesized that providing pediatric patients and their caregivers with a seizure action plan would reduce unplanned health care utilization and decrease the impact of epilepsy.
METHODS


We developed a seizure action plan for use in pediatric epilepsy patients. A prospective cohort was randomly assigned to receive a seizure action plan in addition to standard epilepsy care or to standard epilepsy care alone. All caregivers were surveyed using the Modified Impact on Families (MIF) questionnaire at enrollment, 3 months, and 12 months. Health care utilization measures and Modified Impact on Families questionnaire scores were compared between the 2 groups.
RESULTS


Fifty-four patients received a seizure action plan and standard care, whereas 48 received standard care alone. The groups had similar demographics. There was a significantly higher proportion of overall clinic appointment no shows in the standard care group vs the seizure action plan group ( P  = .04); however, other significant differences in health care utilization were not found. Among patients with low seizure frequency (12 or fewer seizures per year),  Seizure comfort  scores on the Modified Impact on Families questionnaire were significantly higher at 12 months among the seizure action plan group compared to the standard care group.
SIGNIFICANCE


Caregivers for patients with epilepsy receiving a seizure action plan were more comfortable regarding seizure care and missed fewer appointments. However, differences in health care utilization were not present. The seizure action plan appears to have more impact in patients who experience lower seizure frequencies. Further studies evaluating the impact as well as assessing caregivers' perceptions of the seizure action plan using a larger sample are needed.",2019,"There was a significantly higher proportion of overall clinic appointment no shows in the standard care group vs the seizure action plan group ( P = .04); however, other significant differences in health care utilization were not found.","['patients and caregivers better self-manage their epilepsy', 'Caregivers for patients with epilepsy receiving a seizure action plan', 'pediatric epilepsy patients', 'Pediatric Patients With Epilepsy', 'patients who experience lower seizure frequencies']","['seizure action plan in addition to standard epilepsy care or to standard epilepsy care alone', 'seizure action plan', 'standard care alone', 'Seizure Action Plans']","['Families questionnaire scores', 'proportion of overall clinic appointment', 'health care utilization', 'Seizure comfort scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",54.0,0.0835902,"There was a significantly higher proportion of overall clinic appointment no shows in the standard care group vs the seizure action plan group ( P = .04); however, other significant differences in health care utilization were not found.","[{'ForeName': 'Dara V F', 'Initials': 'DVF', 'LastName': 'Albert', 'Affiliation': ""1 Nationwide Children's Hospital/Ohio State University, Department of Pediatrics, Division of Child Neurology, Columbus, OH, USA.""}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Moreland', 'Affiliation': ""2 Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Salvator', 'Affiliation': ""2 Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Moore-Clingenpeel', 'Affiliation': ""2 Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Babitha', 'Initials': 'B', 'LastName': 'Haridas', 'Affiliation': ""3 Oshei Children's Hospital/University at Buffalo, Department of Pediatric Neurology, Buffalo, NY, USA.""}, {'ForeName': 'Justin W', 'Initials': 'JW', 'LastName': 'Cole', 'Affiliation': '4 Cedarville University School of Pharmacy, Department of Pharmacy Practice, Cedarville, OH, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Glynn', 'Affiliation': ""2 Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Marci', 'Initials': 'M', 'LastName': 'Fults', 'Affiliation': ""1 Nationwide Children's Hospital/Ohio State University, Department of Pediatrics, Division of Child Neurology, Columbus, OH, USA.""}, {'ForeName': 'M Zachary', 'Initials': 'MZ', 'LastName': 'Dawson', 'Affiliation': '5 Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Moreland', 'Affiliation': ""6 Nationwide Children's Hospital, Department of Information Services, Columbus, OH, USA.""}, {'ForeName': 'Anup D', 'Initials': 'AD', 'LastName': 'Patel', 'Affiliation': ""1 Nationwide Children's Hospital/Ohio State University, Department of Pediatrics, Division of Child Neurology, Columbus, OH, USA.""}]",Journal of child neurology,['10.1177/0883073819846810']
698,31119822,Exploring compassionate attributes and skills among individuals participating in compassion-focused therapy for enhancing well-being.,"OBJECTIVES


The conceptual approach of compassion underlying compassion-focused therapy (CFT) is based on theoretical rather than empirical grounds. The aim of the present study was to seek empirical support for components of compassion as outlined in the theoretical model underpinning CFT, and to explore which components, if any, matter most for improving well-being.
DESIGN


A sequential exploratory mixed methods design was employed.
METHODS


Alongside a randomized controlled trial (RCT), we systematically examined 625 emails sent by 87 RCT participants to five counsellors during the course of a well-being enhancing CFT self-help intervention, to identify theoretically based compassionate attributes and skills. Next, in a quantitative analysis, we compared participants who did and did not show clinically relevant improvement on well-being with regard to the occurrence of compassionate attributes and skills.
RESULTS


Although the theoretical model of compassion integral to CFT was largely supported by the emails, it was slightly simplified so as to better fit the data. The adjusted model comprises five compassionate attributes (i.e., care for well-being, sensitivity, empathy, distress tolerance, and common humanity) and four compassionate skills (i.e., compassionate attention, reasoning, behaviour, and feeling/sensation). Three illustrative cases are presented to contribute to a better understanding of fundamental components of compassion. Quantitative analyses indicate that participants showing clinically relevant improvement on well-being expressed significantly more compassionate feeling/sensation compared to those who did not.
CONCLUSIONS


We found preliminary evidence for the conceptualization of compassion underlying CFT. Compassionate feeling/sensation bears particular interest when well-being is the intended outcome of CFT.
PRACTITIONER POINTS


Individuals participating in compassion-focused therapy for enhancing well-being experience a wide range of compassionate attributes and skills. Compassion-focused therapy may instigate well-being if a client is able to experience compassionate feeling/sensation.",2020,"Quantitative analyses indicate that participants showing clinically relevant improvement on well-being expressed significantly more compassionate feeling/sensation compared to those who did not.
","['625 emails sent by 87 RCT participants to five counsellors during the course of a well-being enhancing CFT self-help intervention, to identify theoretically based compassionate attributes and skills', 'individuals participating in compassion-focused therapy for enhancing well-being']",['compassion underlying compassion-focused therapy (CFT'],['compassionate feeling/sensation'],"[{'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",,0.0446649,"Quantitative analyses indicate that participants showing clinically relevant improvement on well-being expressed significantly more compassionate feeling/sensation compared to those who did not.
","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Sommers-Spijkerman', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Teuntje R', 'Initials': 'TR', 'LastName': 'Elfrink', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Constance H C', 'Initials': 'CHC', 'LastName': 'Drossaert', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Karlein M G', 'Initials': 'KMG', 'LastName': 'Schreurs', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}]",Psychology and psychotherapy,['10.1111/papt.12235']
699,31745855,Racial Differences in the Effectiveness of Internet-Delivered Mental Health Care.,"BACKGROUND


Computerized cognitive behavioral therapy (cCBT) can improve mental health outcomes in White populations; however, it is unknown whether racial and ethnic minority populations receive clinical benefits from cCBT.
OBJECTIVE


To study race differences in the impact of cCBT use on mental health outcomes among White and African American primary care patients.
DESIGN


Secondary analysis of a three-arm randomized controlled clinical trial.
PARTICIPANTS


Primary care physicians (PCPs) referred 2,884 patients aged 18-75; 954 met eligibility criteria (including elevated mood and/or anxiety symptoms indicated as a score ≥ 10 on Patient Health Questionnaire or Generalized Anxiety Disorder scale); 704 were randomized in 3:3:1 ratio to receive either (1) the cCBT program (cCBT-only), (2) cCBT plus access to an Internet Support Group (cCBT+ISG), or (3) their PCP's usual care (UC). After exclusions, this study analyzed 689 patients: 590 receiving cCBT, in the combined cCBT-only and cCBT+ISG groups (91 African American, 499 White), and 99 receiving UC (22 African American, 77 White).
INTERVENTION(S)


We used the Beating the Blues cCBT program that consisted of eight 50-min Internet-delivered interactive sessions and ""homework"" assignments to complete between weekly sessions. College graduate-level care coaches provided six months of remote support.
MAIN MEASURE(S)


After prior analyses demonstrated no effect of the ISG program, we combined the cCBT-only and cCBT+ISG groups (cCBT) to compare to UC at 6-month follow-up. Controlling for sociodemographic factors, baseline symptoms, and treatment arm, we examined race differences for impact of cCBT versus UC on the mental health-related quality-of-life (Short-form 12 Health Survey), and Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety, and depression.
RESULTS


Compared to UC, cCBT had no effect on quality of life (d = 0.10; p = 0.40), depression (d = - 0.19; p = 0.10), or anxiety (d = - 0.16; p = 0.18) for Whites. However, for African American patients, cCBT was associated with significant 6-month decrease in depression (d = - 0.47, p < 0.01) and anxiety scores (d = - 0.54, p < 0.01).
CONCLUSIONS


cCBT may be an efficient and scalable first step to eliminating disparities in mental health care.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT01482806. https://www.clinicaltrials.gov/ct2/show/NCT01482806?term=rollman&rank=4.",2020,"Compared to UC, cCBT had no effect on quality of life (d = 0.10; p = 0.40), depression (d = - 0.19; p = 0.10), or anxiety (d = - 0.16; p = 0.18) for Whites.","['689 patients: 590 receiving cCBT, in the combined cCBT-only and cCBT+ISG groups (91 African American, 499 White), and 99 receiving UC (22 African American, 77 White', 'White and African American primary care patients', 'Primary care physicians (PCPs) referred 2,884 patients aged 18-75; 954 met eligibility criteria (including elevated mood and/or anxiety symptoms indicated as a score ≥ 10 on Patient Health Questionnaire or Generalized Anxiety Disorder scale); 704', 'College graduate-level care coaches', 'White populations']","['Computerized cognitive behavioral therapy (cCBT', ""cCBT program (cCBT-only), (2) cCBT plus access to an Internet Support Group (cCBT+ISG), or (3) their PCP's usual care (UC"", 'cCBT']","['quality of life', 'anxiety scores', 'depression', 'mental health outcomes', 'mental health-related quality-of-life (Short-form 12 Health Survey), and Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety, and depression', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0233479', 'cui_str': 'Elevated mood (finding)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}]",2884.0,0.0831275,"Compared to UC, cCBT had no effect on quality of life (d = 0.10; p = 0.40), depression (d = - 0.19; p = 0.10), or anxiety (d = - 0.16; p = 0.18) for Whites.","[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Jonassaint', 'Affiliation': 'Center for Behavioral Health and Smart Technology, University of Pittsburgh, Pittsburgh, PA, USA. cjonassaint@pitt.edu.'}, {'ForeName': 'Bea Herbeck', 'Initials': 'BH', 'LastName': 'Belnap', 'Affiliation': 'Center for Behavioral Health and Smart Technology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': 'Center for Behavioral Health and Smart Technology, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05542-1']
700,31101487,The effect of EDTA-based chelation on patients with diabetes and peripheral artery disease in the Trial to Assess Chelation Therapy (TACT).,"OBJECTIVE


Approximately 1 in 7 US adults have diabetes; and over 60% of deaths in patients with diabetes have cardiac disease as a principal or contributing cause. Both coronary and peripheral artery disease (PAD) identify high-risk cohorts among patients with diabetes. We have previously demonstrated improved cardiovascular outcomes with edetate disodium-based chelation in post-MI patients with diabetes, enrolled in the Trial to Assess Chelation Therapy (TACT). In these analyses we further studied the effect size of patients with diabetes and severe disease in 2 vascular beds; coronaries, and lower extremity arteries. We questioned whether greater atherosclerotic burden would attenuate the observed beneficial effect of edetate disodium infusions.
RESEARCH DESIGN AND METHODS


The multicenter TACT used a double blind, placebo controlled, 2 × 2 factorial design with 1708 participants, randomly assigned to receive edetate disodium-based chelation, or placebo and high dose oral vitamins or placebo. There were 162 (9.5% of 1708) post-MI patients with a diagnosis of diabetes mellitus and PAD for this post hoc analysis. Patients received up to 40 double-blind intravenous infusions of edetate disodium-based chelation, or placebo. The composite primary endpoint of TACT consisted of death from any cause, myocardial infarction, stroke, coronary revascularization and hospitalization for angina.
RESULTS


The median age was 66 years, 15% female, 5% non-Caucasian, and BMI was 31. Insulin was used by 32% of patients. Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint. There was a marked reduction in total mortality from 24% to 11%, although of borderline significance (P = 0.052).
CONCLUSION


Atherosclerotic disease in multiple vascular beds did not attenuate the beneficial effect of edetate disodium infusions in post MI patients with diabetes. Studies now in progress will prospectively test this post hoc finding.",2019,"Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint.","['patients with diabetes', '1708 participants', 'patients with diabetes and peripheral artery disease in the Trial to Assess Chelation Therapy (TACT', 'post MI patients with diabetes', 'The median age was 66\u202fyears, 15% female, 5% non-Caucasian, and BMI was 31', 'patients with diabetes and severe disease in 2 vascular beds; coronaries, and lower extremity arteries', 'post-MI patients with diabetes']","['placebo', 'EDTA-based chelation', 'Chelation Therapy (TACT', 'edetate disodium-based chelation, or placebo and high dose oral vitamins or placebo', 'edetate disodium-based chelation, or placebo', 'disodium-based chelation', 'TACT']","['total mortality', 'cardiovascular outcomes', 'death from any cause, myocardial infarction, stroke, coronary revascularization and hospitalization for angina']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}, {'cui': 'C0618927', 'cui_str': 'TACT'}, {'cui': 'C0856742', 'cui_str': 'Post MI'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}, {'cui': 'C0618927', 'cui_str': 'TACT'}, {'cui': 'C0012695', 'cui_str': 'edetate sodium'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}]",1708.0,0.508501,"Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ujueta', 'Affiliation': 'Department of Medicine, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Ivan A', 'Initials': 'IA', 'LastName': 'Arenas', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Escolar', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Diaz', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Boineau', 'Affiliation': 'National Center of Complementary and Integrative Health (NCCIH), Bethesda, MD, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Golden', 'Affiliation': 'The Golden Center for Integrative Medicine, Fresno, CA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lindblad', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Department of Medicine, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA; Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA. Electronic address: gervasio.lamas@msmc.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.04.005']
701,31081373,"Swimming training improves mental health parameters, cognition and motor coordination in children with Attention Deficit Hyperactivity Disorder.","The aim of this study was to verify the effects of swimming-learning program of mental health parameters, cognition and motor coordination in students with Attention Deficit Hyperactivity Disorder (ADHD). Thirty-three children of both sexes between 11 and 14 years were randomized into trained group (n = 18) and untrained group (n = 15). The training was performed for 8 weeks. Then, before and after 48 h of training period of both groups were submitted to find the mental health, cognition, motor coordination test, and physical fitness. Our results demonstrate that the aquatic exercise program significantly improved the depression parameters (p = 0.048), stress (p = 0.039), cognitive flexibility (p = 0.042) and selective attention (p = 0.047). In relation to motor coordination and physical fitness, the results showed significant improvements in the coordination of lower limbs laterality (p = 0.05), flexibility (p = 0.049), and abdominal resistance (p = 0.037). Taken together, the results suggest that swimming-learning program significantly improved the mental health, cognition, and motor coordination in children with ADHD.",2020,"Our results demonstrate that the aquatic exercise program significantly improved the depression parameters (p = 0.048), stress (p = 0.039), cognitive flexibility (p = 0.042) and selective attention (p = 0.047).","['children with Attention Deficit Hyperactivity Disorder', 'students with Attention Deficit Hyperactivity Disorder (ADHD', 'Thirty-three children of both sexes between 11 and 14 years', 'children with ADHD']","['Swimming training', 'swimming-learning program', 'aquatic exercise program']","['selective attention', 'flexibility', 'mental health, cognition, and motor coordination', 'abdominal resistance', 'mental health parameters, cognition and motor coordination', 'coordination of lower limbs laterality', 'cognitive flexibility', 'depression parameters']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",33.0,0.0116623,"Our results demonstrate that the aquatic exercise program significantly improved the depression parameters (p = 0.048), stress (p = 0.039), cognitive flexibility (p = 0.042) and selective attention (p = 0.047).","[{'ForeName': 'Luciano Acordi Da', 'Initials': 'LAD', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Exercise Psychophysiology, Advanced Aquatic Exercise Research Group, Universidade do Extremo Sul Catarinense , Criciúma, Brazil.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Doyenart', 'Affiliation': 'Laboratory of Exercise Psychophysiology, Advanced Aquatic Exercise Research Group, Universidade do Extremo Sul Catarinense , Criciúma, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Henrique Salvan', 'Affiliation': 'Laboratory of Exercise Psychophysiology, Advanced Aquatic Exercise Research Group, Universidade do Extremo Sul Catarinense , Criciúma, Brazil.'}, {'ForeName': 'Welber', 'Initials': 'W', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Exercise Psychophysiology, Advanced Aquatic Exercise Research Group, Universidade do Extremo Sul Catarinense , Criciúma, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Felipe Lopes', 'Affiliation': 'Laboratory of Exercise Psychophysiology, Advanced Aquatic Exercise Research Group, Universidade do Extremo Sul Catarinense , Criciúma, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gomes', 'Affiliation': 'Laboratory of Exercise Psychophysiology, Advanced Aquatic Exercise Research Group, Universidade do Extremo Sul Catarinense , Criciúma, Brazil.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Thirupathi', 'Affiliation': 'Laboratory of Molecular Iron Metabolism, College of Life Science, Hebei Normal University , Shijiazhuang, Hebei, China.'}, {'ForeName': 'Ricardo Aurino De', 'Initials': 'RA', 'LastName': 'Pinho', 'Affiliation': 'Laboratory of Exercise Biochemistry in Health, Graduate Program in Health Sciences, School of Medicine, Pontifícia Universidade Católica do Paraná , Curitiba, Brazil.'}, {'ForeName': 'Paulo Cesar', 'Initials': 'PC', 'LastName': 'Silveira', 'Affiliation': 'Laboratory of Experimental Physiopathology, Graduate Program in Health Sciences, Universidade do Extremo Sul Catarinense , Criciúma, Brazil.'}]",International journal of environmental health research,['10.1080/09603123.2019.1612041']
702,31153789,Different weekly frequencies of Pilates did not accelerate pain improvement in patients with chronic low back pain.,"BACKGROUND


Recent evidence recommends Pilates for the treatment of chronic low back pain. However, it is still unknown if different weekly frequencies of Pilates can accelerate the improvement of symptoms in patients with chronic low back pain verified by a daily pain assessment.
OBJECTIVE


To analyze whether different weekly frequencies of Pilates can accelerate pain reduction by 30%, 50%, and 100% in patients with non-specific chronic low back pain and the necessary number of weeks to reach these improvements.
METHODS


Two hundred and twenty-two patients were randomized into three groups: Pilates group 1 received treatment once a week, Pilates group 2 received treatment twice a week, and Pilates group 3 received treatment three times a week. All groups received Pilates for six weeks. Pain intensity was measured daily before and after each intervention session using the Pain Numerical Rating Scale. The assessor was not blind.
RESULTS


The survival analysis showed that all Pilates groups had a pain reduction of 30%, 50%, and 100% at the same speed during treatment. There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05). After the first week of treatment, 44.6% of the patients in Pilates group 3 showed complete pain improvement, followed by 37.8% of the patients in Pilates group 2 and 29.7% in Pilates group 1. After the last week, 71.6% (Pilates group 1), 77% (Pilates group 2), and 78.4% (Pilates group 3) of the patients reported complete improvement of symptoms.
CONCLUSION


Different weekly frequencies of Pilates did not accelerate pain improvement in patients with non-specific chronic low back pain. Registered in Clinical Trials Registry: NCT02241538 (https://clinicaltrials.gov/ct2/show/NCT02241538).",2020,There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05).,"['Two hundred and twenty-two patients', 'patients with chronic low back pain', 'patients with non-specific chronic low back pain', 'chronic low back pain']",[],"['pain improvement', 'pain reduction', 'Pain intensity', 'complete improvement of symptoms', 'survival analysis', 'Pain Numerical Rating Scale', 'complete pain improvement']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0222045'}]",222.0,0.0593448,There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05).,"[{'ForeName': 'Maria Liliane da', 'Initials': 'MLD', 'LastName': 'Silva', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Gisela Cristiane', 'Initials': 'GC', 'LastName': 'Miyamoto', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil. Electronic address: gfisio_miyamoto@hotmail.com.""}, {'ForeName': 'Katherinne Ferro Moura', 'Initials': 'KFM', 'LastName': 'Franco', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Yuri Rafael Dos Santos', 'Initials': 'YRDS', 'LastName': 'Franco', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}, {'ForeName': 'Cristina Maria Nunes', 'Initials': 'CMN', 'LastName': 'Cabral', 'Affiliation': ""Master's and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.""}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.05.001']
703,31122650,Encoding or consolidation? The effects of pre- and post-learning propranolol on the impact of an emotional scene.,"BACKGROUND AND OBJECTIVES


Researchers have conceived of post-traumatic stress disorder (PTSD) as a disorder of memory, and proposed that blocking the impact of stress-related noradrenaline release in the aftermath of trauma may be a way of preventing the 'over-consolidation' of trauma-related memories. Experimental research in humans has been limited by typically focusing on declarative memory for emotional stories, and has mainly given propranolol before learning. In contrast, the clinical studies that we comprehensively review are hampered by practical challenges, such as reliably administering propranolol in a time window sufficiently close to the traumatic event. In this study, we aimed to assess the impact of both pre- and post-learning propranolol on emotional and declarative memory for an emotional scene, using the 'trauma film paradigm'.
METHODS


To control for drug and timing effects, participants received a pill (40 mg propranolol or placebo) both 60 min before and within 5 min after viewing a 12 min, emotionally arousing trauma film, and were assigned to one of the three conditions: propranolol-placebo (n = 25), placebo-propranolol (n = 25), or placebo-placebo (n = 25). We assessed participants' immediate emotional responses to the scene, as well as delayed impact (intrusions, Impact of Events Scale) and declarative memory.
RESULTS


Using Bayesian informative hypothesis testing, we found that pre-learning propranolol reduced the initial emotional impact of the 'trauma film'. However, we did not find strong evidence for an impact of pre- or post-learning propranolol on later consequences of having watched the emotional film (intrusions, Impact of Events, or tests of declarative memory). Exploratorily restricting analyses to women, we did find evidence suggesting that pre-encoding propranolol could reduce the rate of intrusions and self-reported negative impact of the emotional scene one week later.
LIMITATIONS


Floor effects in the delayed impact of the emotional scene could preclude observing differences as a function of propranolol, and propranolol dosage may need to be increased.
CONCLUSIONS


An impact of propranolol on encoding could raise difficulties in interpretation when only pre-encoding propranolol is used to make inferences about consolidation. We discuss the challenges of elucidating the mechanistic underpinnings of propranolol's reported effects on memory.",2020,"However, we did not find strong evidence for an impact of pre- or post-learning propranolol on later consequences of having watched the emotional film (intrusions, Impact of Events, or tests of declarative memory).",[],"['placebo-placebo', 'placebo-propranolol', 'propranolol', 'propranolol-placebo', 'pre- and post-learning propranolol', 'pill (40\u202fmg propranolol or placebo']","['later consequences of having watched the emotional film (intrusions, Impact of Events, or tests of declarative memory', 'delayed impact (intrusions, Impact of Events Scale) and declarative memory', 'emotional and declarative memory']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}]","[{'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}]",,0.147688,"However, we did not find strong evidence for an impact of pre- or post-learning propranolol on later consequences of having watched the emotional film (intrusions, Impact of Events, or tests of declarative memory).","[{'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Elsey', 'Affiliation': 'University of Amsterdam, Netherlands. Electronic address: j.w.b.elsey@uva.nl.'}, {'ForeName': 'Tamar A', 'Initials': 'TA', 'LastName': 'Bekker', 'Affiliation': 'University of Amsterdam, Netherlands.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'De Bree', 'Affiliation': 'University of Amsterdam, Netherlands.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'University of Amsterdam, Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101480']
704,31122717,Short period of high-intensity inspiratory muscle training improves inspiratory muscle strength in patients with chronic kidney disease on hemodialysis: a randomized controlled trial.,"BACKGROUND


Chronic kidney disease is a complex disease that impacts multiple organs and systems (including musculoskeletal and cardiorespiratory) leading to reduction of functional capacity.
OBJECTIVE


The aim of this study was to investigate the effect of a short period of high intensity inspiratory muscle training on maximum inspiratory pressure, functional capacity and endothelial function of chronic kidney disease patients on hemodialysis.
METHODS


This randomized controlled trial enrolled 25 patients who were allocated into two groups: intervention (IMTG=14) and control (CG=11) groups. Intervention patients received the exercise protocol over a period of 5 weeks, 6 times per week, with each session consisting of 5 sets of 10 repetitions with an initial load of 50% progressing to 70% of maximum inspiratory pressure , measured weekly. The primary outcome was inspiratory muscle strength and the secondary outcomes were functional capacity and endothelial function evaluated before and after the training protocol.
RESULTS


The inspiratory muscle training induced a marked improvement in maximum inspiratory pressure which was evident after the training period (mean difference 19.0cmH 2 O - 95%CI 0.4-37.5; IMTG: 102±25.7cmH 2 O vs CG: 83±19.2; p=0.046). The magnitude of maximum inspiratory pressure improvement was 33.5% at the end of the protocol for the IMTG. Functional capacity and endothelial function did not vary between or within groups.
CONCLUSION


A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).",2020,A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).,"['chronic kidney disease patients', 'patients with chronic kidney disease on hemodialysis', 'chronic kidney disease patients on hemodialysis', '25 patients']","['high intensity inspiratory muscle training', 'high-intensity inspiratory muscle training', 'exercise protocol', 'IMTG']","['inspiratory muscle strength', 'maximum inspiratory pressure improvement', 'maximum inspiratory pressure, functional capacity and endothelial function', 'maximum inspiratory pressure', 'Functional capacity and endothelial function', 'inspiratory muscle strength and the secondary outcomes were functional capacity and endothelial function']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",25.0,0.10348,A short period of high-intensity inspiratory muscle training for five weeks was able to improve inspiratory muscle strength of chronic kidney disease patients on hemodialysis (ClinicalTrials.gov registration NCT03082404).,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dipp', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil. Electronic address: thdipp@hotmail.com.'}, {'ForeName': 'Fabrício Edler', 'Initials': 'FE', 'LastName': 'Macagnan', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jociane', 'Initials': 'J', 'LastName': 'Schardong', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael Oliveira', 'Initials': 'RO', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physiology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Luisa Cioato', 'Initials': 'LC', 'LastName': 'Lemos', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo Della Méa', 'Initials': 'RDM', 'LastName': 'Plentz', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.04.003']
705,31532482,Challenges and opportunities using online portals to recruit diverse patients to behavioral trials.,"We describe the use of an online patient portal to recruit and enroll primary care patients in a randomized trial testing the effectiveness of a colorectal cancer (CRC) screening decision support program. We use multiple logistic regression to identify patient characteristics associated with trial recruitment, enrollment, and engagement. We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93). We also found that compared to Whites, Asians had lower odds of viewing the portal message (OR = 0.53, 95% CI = 0.33-0.64), opening the attached link containing the study material (OR = 0.76, 95% CI = 0.54-0.97), consenting to participate in the trial (OR = 0.68, 95% CI = 0.53-0.95), and completing the trial's baseline questionnaire (OR = 0.59, 95% CI = 0.36-0.90). While portals offer an opportunity to mitigate human bias in trial invitations, because of racial disparities-not only in who has a portal account, but in how they interact with trial recruitment and enrollment material within the portal-using portals alone for trial recruitment may generate study samples that are not racially diverse.",2019,"We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93).",[],['colorectal cancer (CRC) screening decision support program'],['viewing the portal message'],[],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}]",,0.136261,"We found that compared to Whites, Blacks had lower odds of viewing the portal message (OR = 0.46, 95% CI = 0.37-0.57), opening the attached link containing the study material (OR = 0.75, 95% CI = 0.62-0.92), and consenting to participate in the trial (OR = 0.85, 95% CI = 0.67-0.93).","[{'ForeName': 'Amir Alishahi', 'Initials': 'AA', 'LastName': 'Tabriz', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Patrice Jordan', 'Initials': 'PJ', 'LastName': 'Fleming', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yongyun', 'Initials': 'Y', 'LastName': 'Shin', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Resa M', 'Initials': 'RM', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health and Fox Chase Cancer Center, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Flocke', 'Affiliation': 'Department of Family Medicine, Oregon Health Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Shires', 'Affiliation': 'School of Social Work, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Hawley', 'Affiliation': 'Department of Medicine, Center for Health Communications Research, University of Michigan and Ann Arbor VA Center for Clinical Management Research, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Willens', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan, USA.'}, {'ForeName': 'Jennifer Elston', 'Initials': 'JE', 'LastName': 'Lafata', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz157']
706,31097515,Differential blood pressure response to continuous positive airway pressure treatment according to the circadian pattern in hypertensive patients with obstructive sleep apnoea.,"Continuous positive airway pressure (CPAP) has a heterogeneous effect on blood pressure (BP) in hypertensive patients. However, the effect of CPAP on BP in hypertensive subjects regarding circadian BP pattern has never been explored. This study aimed to assess the effect of CPAP on BP, taking into consideration the circadian BP pattern in untreated hypertensive patients.This study is a  post hoc  analysis of the Spanish Cohort for the Study of the Effect of CPAP in Hypertension (CEPECTA), a multicentre, randomised trial of CPAP  versus  sham-CPAP in patients with new-onset systemic hypertension and an apnoea-hypopnoea index >15 events·h -1  We included patients for whom 24-h ambulatory BP monitoring (ABPM) data were available at baseline and 12 weeks after the intervention. Subjects were classified based on the dipping ratio (dipper/non-dipper). We evaluated the effect of CPAP on ABPM parameters after 12 weeks of treatment.Overall, 272 hypertensive subjects were included in the analysis (113 dippers and 159 non-dippers). Baseline clinical and polysomnographic variables were similar between the groups. CPAP treatment in non-dipper patients was associated with reductions in 24-h ambulatory BP variables and night-time ambulatory BP measurements. However, a nonsignificant effect was reported in the dipper group. The differential effects of CPAP between the groups were -2.99 mmHg (95% CI -5.92-- -0.06 mmHg) for the mean 24-h ambulatory BP and -5.35 mmHg (95% CI -9.01- -1.69 mmHg) for the mean night-time ambulatory BP.Our results show a differential effect of CPAP treatment on BP in hypertensive patients depending on the circadian pattern. Only non-dipper patients benefited from CPAP treatment in terms of BP reduction.",2019,CPAP treatment in nondipper patients was associated with reductions in 24-h ambulatory BP variables and nighttime ambulatory BP measurements.,"['hypertensive patients with obstructive sleep apnea', 'untreated hypertensive patients', 'hypertensive patients depending on the circadian pattern', 'hypertensive patients', 'hypertensive subjects', '272 hypertensive subjects were included in the analysis (113 dippers/159 nondippers', 'patients with new-onset systemic hypertension and an apnea/hypopnea index']","['sham-CPAP', 'CPAP treatment', 'CPAP', 'Introduction:  Continuous positive airway pressure (CPAP']","['24-h ambulatory BP monitoring (ABPM) data', 'Differential blood pressure response', 'BP reduction', '24-h ambulatory BP variables and nighttime ambulatory BP measurements', 'blood pressure (BP', 'ABPM parameters']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",272.0,0.023483,CPAP treatment in nondipper patients was associated with reductions in 24-h ambulatory BP variables and nighttime ambulatory BP measurements.,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sapiña-Beltrán', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Torres', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santamaría-Martos', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Durán-Cantolla', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Sánchez-de-la-Torre', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Dalmases', 'Affiliation': 'Hospital Universitari Arnau de Vilanova and Santa Maria, Group of Translational Research in Respiratory Medicine, IRB Lleida, Universitat de Lleida, Lleida, Spain mdalmases.lleida.ics@gencat.cat.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.00098-2019']
707,31109849,"Hereditary angioedema, emergency management of attacks by a call center.","OBJECTIVE


Hereditary angiœdema (HAE) is a rare autosomal dominant disease characterized by recurrent, unpredictable, potentially life-threatening swelling. Objective is to assess the management of the acute HAE attacks in the real life setting through a call center in France.
METHODS


A pre-specified ancillary study of SOS-HAE, a cluster-randomized prospective multicenter trial, was conducted. HAE patients were recruited from 8 participating reference centers. The outcome of interest was the rate of hospitalization.
RESULTS


onerhundred patients were included. The median (quartile) age was 38 (29-53) years, and 66 (66%) were female. Eighty (80%) patients had HAE type I, 8 (8%) had HAE type II and 12 (12%) patients had FXII-HAE. Fifty-one (51%) patients had experienced at least one time the call center during the follow-up. Nine over 166 (5%) attacks for 9 different patients resulted in hospital admission to the hospital (in the short-stay unit, ie, <24 h) during the follow-up period. During 2 years, there were 166 calls to call center for 166 attacks. All attacks were treated at home after call center contact.
CONCLUSIONS


Use of emergency departments and hospitalizations are reduced by the use of a coordinated national call center in HAE after therapeutic education program that promoted self-administration of specific treatment and use of call to call center.
TRIAL REGISTRATION


clinicalTrials.gov identifier: NCT01679912.",2019,"CONCLUSIONS


Use of emergency departments and hospitalizations are reduced by the use of a coordinated national call center in HAE after therapeutic education program that promoted self-administration of specific treatment and use of call to call center.
","['onerhundred patients were included', 'Eighty (80', 'Fifty-one (51', 'HAE patients were recruited from 8 participating reference centers', 'patients had HAE type I, 8 (8%) had HAE type II and 12 (12', 'The median (quartile) age was 38 (29-53) years, and 66 (66%) were female']",['SOS-HAE'],"['rate of hospitalization', 'FXII-HAE', 'hospital admission to the hospital']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.0954971,"CONCLUSIONS


Use of emergency departments and hospitalizations are reduced by the use of a coordinated national call center in HAE after therapeutic education program that promoted self-administration of specific treatment and use of call to call center.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Javaud', 'Affiliation': 'AP-HP, Urgences, Centre de référence sur les angiœdèmes à kinines, Hôpital Louis Mourier, Université Paris 7, 92700 Colombes, France; AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: nicolas.javaud@aphp.fr.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Altar', 'Affiliation': 'AP-HP, Urgences, Centre de référence sur les angiœdèmes à kinines, Hôpital Louis Mourier, Université Paris 7, 92700 Colombes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fain', 'Affiliation': 'AP-HP, Médecine Interne, DHUi2B, Centre de Référence associé sur les angiœdèmes à kinines (CRéAk), Hôpital Saint-Antoine, Université Paris 6, 75 012 Paris, France. Electronic address: olivier.fain@aphp.fr.'}, {'ForeName': 'Paul-Georges', 'Initials': 'PG', 'LastName': 'Reuter', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: paul-georges.reuter@aphp.fr.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Desmaizieres', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: michel.desmaizieres@aphp.fr.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Petrovic', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: tomislav.petrovic@aphp.fr.'}, {'ForeName': 'Aiham', 'Initials': 'A', 'LastName': 'Ghazali', 'Affiliation': 'AP-HP, Urgences, Hôpital Bichat, Université Paris 7, 75018 Paris, France.. Electronic address: aiham.ghazali@aphp.fr.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""AP-HP, URCEco Ile de France, Hôpital de l'Hôtel-Dieu, Université Paris 12, 75 004 Paris, France. Electronic address: isabelle.durand-zaleski@aphp.fr.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Bouillet', 'Affiliation': 'Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU de Grenoble, 38043 Grenoble, France. Electronic address: LBouillet@chu-grenoble.fr.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'AP-HP, Unité de Recherche Clinique, Hôpital Fernand Widal, Paris, France. Electronic address: eric.vicaut@aphp.fr.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Launay', 'Affiliation': 'Université de Lille, CHRU de Lille, Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), Hôpital Claude Huriez, 59037 Lille Cedex, France. Electronic address: david.launay@chru-lille.fr.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': ""Dermatologie, Centre de Référence sur les angiœdèmes à kinines (CRéAk), Université d'Angers, CHU d'Angers, 49 933 Angers, cedex, France. Electronic address: LuMartin@chu-angers.fr.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Floccard', 'Affiliation': 'Hospices Civils de Lyon, Réanimation, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU Edouard Herriot, 69 437 Lyon, Cedex, France. Electronic address: bernard.floccard@chu-lyon.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gompel', 'Affiliation': 'Université de Paris-Descartes, AP-HP, HUPC, Unité de Gynécologie Endocrinienne, Hôpital Port Royal, 75001 Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Sobel', 'Affiliation': 'AP-HP, Hôpital Hôtel Dieu, Université Paris 5, 75004 Paris, France. Electronic address: alain.sobel@aphp.fr.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boccon-Gibod', 'Affiliation': 'Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU de Grenoble, 38043 Grenoble, France. Electronic address: IBoccon-gibod@chu-grenoble.fr.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Kanny', 'Affiliation': 'Médecine Interne, Centre de Référence sur les angiœdèmes à kinines (CRéAk), CHU de Nancy, 54 035 Nancy, France. Electronic address: gisele.kanny@univ-lorraine.fr.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: frederic.lapostolle@aphp.fr.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'AP-HP, Urgences - Samu 93, Hôpital Avicenne, Université Paris 13, Inserm U942, 93000 Bobigny, France. Electronic address: frederic.adnet@aphp.fr.'}]",European journal of internal medicine,['10.1016/j.ejim.2019.05.007']
708,31735256,Use of a new composite index to demonstrate improved stereoacuity after training on stimuli with dichoptically asymmetric contrast.,"Many people with stereo-deficiency cannot perform stereoacuity tasks at any binocular disparity, so their threshold cannot be measured. We developed a generally useful new composite stereodepth or CSD score, with range 0 to 20, that combines stereoacuity (from 0 to 13.3) and percent correct (13.3 to 20) into a single index. CSD allows differences in stereodepth performance to be measured across groups when thresholds cannot be reliably measured, and across time when individuals gain stereodepth perception during training. We used CSD scores to assess the benefit of unequal (mixed) left- and right-eye contrast during dichoptic stereoacuity training in people with amblyopia. Nineteen adult participants with anisometropic amblyopia were assigned randomly to 10 sessions of either mixed-contrast or fixed-contrast training. Stimuli were rectangles, one above the other, viewed through a four-mirror stereoscope. Participants indicated which rectangle appeared closer. A staircase controlled disparity within the stimulus. CSD improvement was better by 1.6 CSD units for participants who received mixed-contrast training. Thus, mixed-contrast stereo training was more effective than fixed-contrast training in adults with anisometropic amblyopia.",2020,CSD improvement was better by 1.6 CSD units for participants who received mixed-contrast training.,"['adults with anisometropic amblyopia', 'people with amblyopia', 'Nineteen adult participants with anisometropic amblyopia']","['mixed-contrast or fixed-contrast training', 'unequal (mixed) left- and right-eye contrast during dichoptic stereoacuity training', 'fixed-contrast training']",['CSD improvement'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0339696', 'cui_str': 'Anisometropic Amblyopia'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242503', 'cui_str': 'Inequalities'}, {'cui': 'C0229089', 'cui_str': 'RE - Right eye'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}]",[],19.0,0.0410934,CSD improvement was better by 1.6 CSD units for participants who received mixed-contrast training.,"[{'ForeName': 'Cristina Llerena', 'Initials': 'CL', 'LastName': 'Law', 'Affiliation': 'College of Optometry, Nova Southeastern University, 3200 South University Drive, Ft. Lauderdale, FL 33328, USA; SUNY College of Optometry, 33 West 42 Street, New York, NY 10036, USA. Electronic address: lcristin@nova.edu.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Backus', 'Affiliation': 'SUNY College of Optometry, 33 West 42 Street, New York, NY 10036, USA; Vivid Vision, Inc., 525 York St., San Francisco, CA 94110, USA. Electronic address: bbackus@sunyopt.edu.'}]",Vision research,['10.1016/j.visres.2019.10.005']
709,31738179,Quality Awareness and Its Influence on the Evaluation of App Meta-Information by Physicians: Validation Study.,"BACKGROUND


Meta-information provided about health apps on app stores is often the only readily available source of quality-related information before installation.
OBJECTIVE


The purpose of this study was to assess whether physicians deem a predefined set of quality principles as relevant for health apps; whether they are able to identify corresponding information in a given sample of app descriptions; and whether, and how, this facilitates their informed usage decisions.
METHODS


All members of the German Society for Internal Medicine were invited by email to participate in an anonymous online survey over a 6-week period. Participants were randomly assigned one app description focusing on cardiology or pulmonology. In the survey, participants were asked three times about whether the assigned description sufficed for a usage decision: they were asked (1) after giving an appraisal of the relevance of nine predefined app quality principles, (2) after determining whether the descriptions covered the quality principles, and (3) after they assessed the availability of detailed quality information by means of 25 additional key questions. Tests for significance of changes in their decisions between assessments 1 and 2, and between assessments 2 and 3, were conducted with the McNemar-Bowker test of symmetry. The effect size represents the discordant proportion ratio sum as a quotient of the test statistics of the Bowker test and the number of observation units. The significance level was set to alpha=.05 with a power of 1-beta=.95.
RESULTS


A total of 441 of 724 participants (60.9%) who started the survey fully completed the questionnaires and were included in the evaluation. The participants predominantly rated the specified nine quality principles as important for their decision (approximately 80%-99% of ratings). However, apart from the practicality criterion, information provided in the app descriptions was lacking for both groups (approximately 51%-92%). Reassessment of the apps led to more critical assessments among both groups. After having familiarized themselves with the nine quality principles, approximately one-third of the participants (group A: 63/220, 28.6%; group B: 62/221, 28.1%) came to more critical usage decisions in a statistically significant manner (McNemar-Bowker test, groups A and B: P<.001). After a subsequent reassessment with 25 key questions, critical appraisals further increased, although not in a statistically significant manner (McNemar-Bowker, group A: P=.13; group B: P=.05).
CONCLUSIONS


Sensitizing physicians to the topic of quality principles via questions about attitudes toward established quality principles, and letting them apply these principles to app descriptions, lead to more critical appraisals of the sufficiency of the information they provided. Even working with only nine generic criteria was sufficient to bring about the majority of decision changes. This may lay the foundation for aiding physicians in their app-related decision processes, without unduly taking up their valuable time.",2019,"After a subsequent reassessment with 25 key questions, critical appraisals further increased, although not in a statistically significant manner (McNemar-Bowker, group A","['All members of the German Society for Internal Medicine were invited by email to participate in an anonymous online survey over a 6-week period', 'A total of 441 of 724 participants (60.9%) who started the survey fully completed the questionnaires and were included in the evaluation']",['cardiology or pulmonology'],[],"[{'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}]",[],724.0,0.0503387,"After a subsequent reassessment with 25 key questions, critical appraisals further increased, although not in a statistically significant manner (McNemar-Bowker, group A","[{'ForeName': 'Urs-Vito', 'Initials': 'UV', 'LastName': 'Albrecht', 'Affiliation': 'Peter L Reichertz Institute for Medical Informatics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Framke', 'Affiliation': 'Institute for Biometry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'von Jan', 'Affiliation': 'Peter L Reichertz Institute for Medical Informatics, Hannover Medical School, Hannover, Germany.'}]",JMIR mHealth and uHealth,['10.2196/16442']
710,31074484,Physiotherapy Based on a Biobehavioral Approach with or Without Orthopedic Manual Physical Therapy in the Treatment of Nonspecific Chronic Low Back Pain: A Randomized Controlled Trial.,"OBJECTIVE


To compare the effectiveness of a biobehavioral approach with and without orthopedic manual physical therapy on the intensity and frequency of pain in patients diagnosed with nonspecific chronic low back pain.
METHODS


A single-blind randomized controlled trial. Fifty patients were randomly allocated into two groups: one group received biobehavioral therapy with orthopedic manual physical therapy, and the other group received only biobehavioral therapy. Both groups completed a total of eight sessions, with a frequency of two sessions per week. The somatosensory, physical, and psychological variables were recorded at baseline and during the first and third month after initiation of treatment.
RESULTS


In both groups, the treatment was effective, presenting significant differences for all the variables in the time factor. There were no significant differences between groups in intensity or frequency of pain, with a large effect size (>0.80), but there were intragroup differences for both intervention groups at one- and three-month follow-up. There were also no significant differences between groups in the secondary variables during the same follow-up period.
CONCLUSIONS


The results of this study suggest that orthopedic manual physical therapy does not increase the effects of a treatment based on biobehavioral therapy in the short or medium term, but these results should be interpreted with caution.",2019,"There were no significant differences between groups in intensity or frequency of pain, with a large effect size (>0.80), but there were intragroup differences for both intervention groups at one- and three-month follow-up.","['Fifty patients', 'Nonspecific Chronic Low Back Pain', 'patients diagnosed with nonspecific chronic low back pain']","['Physiotherapy Based on a Biobehavioral Approach with or Without Orthopedic Manual Physical Therapy', 'biobehavioral therapy with orthopedic manual physical therapy, and the other group received only biobehavioral therapy', 'orthopedic manual physical therapy', 'biobehavioral approach with and without orthopedic manual physical therapy']","['somatosensory, physical, and psychological variables', 'intensity and frequency of pain', 'intensity or frequency of pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4042874', 'cui_str': 'Biobehavioral Model'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",50.0,0.0446797,"There were no significant differences between groups in intensity or frequency of pain, with a large effect size (>0.80), but there were intragroup differences for both intervention groups at one- and three-month follow-up.","[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Grande-Alonso', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Aravaca, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Aravaca, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Aravaca, Madrid, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Pardo-Montero', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Aravaca, Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Gil-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Aravaca, Madrid, Spain.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Aravaca, Madrid, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz093']
711,31729622,"Effects of a multispecies synbiotic on glucose metabolism, lipid marker, gut microbiome composition, gut permeability, and quality of life in diabesity: a randomized, double-blind, placebo-controlled pilot study.","PURPOSE


Diabesity, the combination of obesity and type 2 diabetes, is an ever-growing global health burden. Diabesity-associated dysbiosis of the intestinal microbiome has gained attention as a potential driver of disease and, therefore, a possible therapeutic target by means of pro- or prebiotic supplementation. This study tested the effects of a multispecies synbiotic (i.e. a combination of probiotics and prebiotics) on glucose metabolism, gut microbiota, gut permeability, neutrophil function and quality of life in treatment-experienced diabesity patients.
METHODS


A randomized, double-blind, placebo-controlled pilot study with 26 diabesity patients was conducted in which patients received a daily dose of a multispecies probiotic and a prebiotic (or a placebo) for 6 months.
RESULTS


There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study. The analysis of secondary outcomes revealed beneficial effects on hip circumference [- 1 (95% CI - 4; 3) vs +3 (- 1; 8) cm, synbiotics vs. placebo, respectively, p = 0.04], serum zonulin [- 0.04 (- 0.2; 0.1) vs +0.3 (- 0.05; 0.6) ng/ml, p = 0.004)] and the physical role item of the SF36 quality of life assessment [+ 5.4 (- 1.7; 12.5) vs - 5.0 (- 10.1; 0.2) points, p = 0.02] after 3 months of intervention, and lipoprotein (a) [- 2.1 (- 5.7; 1.6) vs +3.4 (- 0.9; 7.9) mg/dl, p = 0.02] after 6 months. There were no significant differences in alpha or beta diversity of the microbiome between groups or time points.
CONCLUSIONS


Glucose metabolism as the primary outcome was unchanged during the intervention with a multispecies synbiotic in patients with diabesity. Nevertheless, synbiotics improved some symptoms and biomarkers of type 2 diabetes and aspects of quality of life suggesting a potential role as adjuvant tool in the management of diabesity.",2020,There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study.,"['treatment-experienced diabesity patients', 'patients with diabesity', '26 diabesity patients']","['placebo', 'multispecies synbiotic', 'multispecies probiotic and a prebiotic (or a placebo', 'multispecies synbiotic (i.e. a combination of probiotics and prebiotics']","['beneficial effects on hip circumference', 'physical role item of the SF36 quality of life assessment', 'glucose metabolism, gut microbiota, gut permeability, neutrophil function and quality of life', 'serum zonulin', 'glucose metabolism or mixed meal tolerance test responses', 'alpha or beta diversity', 'glucose metabolism, lipid marker, gut microbiome composition, gut permeability, and quality of life in diabesity']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.44428,There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study.,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. angela.horvath@medunigraz.at.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Division of Transplantation Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Feldbacher', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Tripolt', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rainer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Blesl', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Trieb', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Marsche', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sourij', 'Affiliation': 'Center for Biomarker Research in Medicine (CBmed), Stiftingtalstrasse 5, 8010, Graz, Austria.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stadlbauer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}]",European journal of nutrition,['10.1007/s00394-019-02135-w']
712,31852491,Right Dose Right Now: bedside data-driven personalized antibiotic dosing in severe sepsis and septic shock - rationale and design of a multicenter randomized controlled superiority trial.,"BACKGROUND


Antibiotic exposure is often inadequate in critically ill patients with severe sepsis or septic shock and this is associated with worse outcomes. Despite markedly altered and rapidly changing pharmacokinetics in these patients, guidelines and clinicians continue to rely on standard dosing schemes. To address this challenge, we developed AutoKinetics, a clinical decision support system for antibiotic dosing. By feeding large amounts of electronic health record patient data into pharmacokinetic models, patient-specific predicted future plasma concentrations are displayed graphically. In addition, a tailored dosing advice is provided at the bedside in real time. To evaluate the effect of AutoKinetics on pharmacometric and clinical endpoints, we are conducting the Right Dose Right Now multicenter, randomized controlled, two-arm, parallel-group, non-blinded, superiority trial.
METHODS


All adult intensive care patients with a suspected or proven infection and having either lactatemia or receiving vasopressor support are eligible for inclusion. Randomization to the AutoKinetics or control group is initiated at the bedside when prescribing at least one of four commonly administered antibiotics: ceftriaxone, ciprofloxacin, meropenem and vancomycin. Dosing advice is available for patients in the AutoKinetics group, whereas patients in the control group receive standard dosing. The primary outcome of the study is pharmacometric target attainment during the first 24 h. Power analysis revealed the need for inclusion of 42 patients per group per antibiotic. Thus, a total of 336 patients will be included, 168 in each group. Secondary pharmacometric endpoints include time to target attainment and fraction of target attainment during an entire antibiotic course. Secondary clinical endpoints include mortality, clinical cure and days free from organ support. Several other exploratory and subgroup analyses are planned.
DISCUSSION


This is the first randomized controlled trial to assess the effectiveness and safety of bedside data-driven automated antibiotic dosing advice. This is important as adequate antibiotic exposure may be crucial to treat severe sepsis and septic shock. In addition, the trial could prove to be a significant contribution to clinical pharmacometrics and serve as a stepping stone for the use of big data and artificial intelligence in the field.
TRIAL REGISTRATION


Netherlands Trial Register (NTR), NL6501/NTR6689. Registered on 25 August 2017. European Clinical Trials Database (EudraCT), 2017-002478-37. Registered on 6 November 2017.",2019,"BACKGROUND


Antibiotic exposure is often inadequate in critically ill patients with severe sepsis or septic shock and this is associated with worse outcomes.","['critically ill patients with severe sepsis or septic shock', 'All adult intensive care patients with a suspected or proven infection and having either lactatemia or receiving vasopressor support are eligible for inclusion', '336 patients will be included, 168 in each group']","['antibiotics: ceftriaxone, ciprofloxacin, meropenem and vancomycin']","['mortality, clinical cure and days free from organ support', 'pharmacometric target attainment during the first 24\u2009h. Power analysis', 'time to target attainment and fraction of target attainment during an entire antibiotic course']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085559'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",336.0,0.322972,"BACKGROUND


Antibiotic exposure is often inadequate in critically ill patients with severe sepsis or septic shock and this is associated with worse outcomes.","[{'ForeName': 'Luca F', 'Initials': 'LF', 'LastName': 'Roggeveen', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. l.roggeveen@amsterdamumc.nl.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Fleuren', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Tingjie', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Thoral', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Harm Jan', 'Initials': 'HJ', 'LastName': 'de Grooth', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Eleonora L', 'Initials': 'EL', 'LastName': 'Swart', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacy, Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Thomas L T', 'Initials': 'TLT', 'LastName': 'Klausch', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter H J', 'Initials': 'PHJ', 'LastName': 'van der Voort', 'Affiliation': 'Intensive Care Unit, OLVG Oost, Oosterpark 9, 1091 AC, Amsterdam, The Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Bosman', 'Affiliation': 'Intensive Care Unit, OLVG Oost, Oosterpark 9, 1091 AC, Amsterdam, The Netherlands.'}, {'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Research VUmc Intensive Care (REVIVE), Amsterdam Cardiovascular Science (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Location VUmc, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}]",Trials,['10.1186/s13063-019-3911-5']
713,31728681,"Prebiotic supplementation modulates advanced glycation end-products (AGEs), soluble receptor for AGEs (sRAGE), and cardiometabolic risk factors through improving metabolic endotoxemia: a randomized-controlled clinical trial.","PURPOSE


The oxidative stress plays a key role in the initiation, propagation, and development of the complications of type 2 diabetes mellitus (T2DM). This trial aimed to evaluate the effects of resistant dextrin as a prebiotic on the cardiometabolic risk factors and the status of oxidative stress in patients with T2DM.
METHODS


Sixty-five female subjects with T2DM were assigned to either the intervention (n = 33) or control (n = 32) groups receiving 10 g/day of resistant dextrin or placebo, respectively, for 8 weeks. Fasting blood samples were collected at baseline and post-intervention to determine the serum levels of glycemic indices, lipid profile, atherogenic indices, and soluble receptor for AGEs (sRAGE), carboxymethyl lysine (CML), pentosidine, malondialdehyde (MDA), 8-iso-prostaglandin F2α (8-iso-PGF2α), total antioxidant capacity (TAC), antioxidant enzymes activity, and uric acid. Data were analyzed using SPSS software 17. Paired, unpaired Student's t tests, and analysis of covariance were used to compare the quantitative variables.
RESULTS


Resistant dextrin caused a significant decrease in FPG (- 17.43 mg/dl, 9.80%), TG (- 40.25 mg/dl, 23.01%), TC/HDL (- 0.80, 21.87%), LDL-c/HDL-c (- 0.80, 17.85%), Atherogenic index (- 0.40, 15.80%), LPS (- 6.5 EU/ml, 23.40%) and hs-CRP (- 8.02 ng/ml, 54.00%), MDA (- 1.21 nmol/mL, 25.58%), CML (- 93.40 ng/ml, 26.30%), 8-iso-PGF2α (- 4.65 pg/ml, 15.00%), and a significant increase in TAC (0.33 mmol/L, 36.25%) and s-RAGE (2.10 ng/ml, 28.90%) in the intervention group compared with the control group. No significant changes were observed in glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid in the intervention group compared with the control group.
CONCLUSIONS


Supplementation with resistant dextrin may improve the advanced glycation end-products, sRAGE, and cardiometabolic risk factors in women with type 2 diabetes mellitus.",2020,"No significant changes were observed in glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid in the intervention group compared with the control group.
","['women with type 2 diabetes mellitus', 'Sixty-five female subjects with T2DM', 'patients with T2DM']","['control (n\u2009=\u200932) groups receiving 10\xa0g/day of resistant dextrin or placebo', 'Prebiotic supplementation', 'resistant dextrin']","['glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid', 'TAC', 'Fasting blood samples', 'FPG', 'Atherogenic index', '8-iso-PGF2α', 'TC/HDL', 'serum levels of glycemic indices, lipid profile, atherogenic indices, and soluble receptor for AGEs (sRAGE), carboxymethyl lysine (CML), pentosidine, malondialdehyde (MDA), 8-iso-prostaglandin F2α (8-iso-PGF2α), total antioxidant capacity (TAC), antioxidant enzymes activity, and uric acid', 'MDA', 'advanced glycation end-products, sRAGE, and cardiometabolic risk factors']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0054527', 'cui_str': 'caloreen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0070317', 'cui_str': 'pentosidine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4508788', 'cui_str': 'carboxymethyl-lysine'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation Endproducts'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",65.0,0.124877,"No significant changes were observed in glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid in the intervention group compared with the control group.
","[{'ForeName': 'Mahdieh Abbasalizad', 'Initials': 'MA', 'LastName': 'Farhangi', 'Affiliation': 'Drug Applied Research Center, Nutrition Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Dehghan', 'Affiliation': 'Nutrition Research Center, Immunology Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, 5166614711, Iran. dehghan.nut@gmail.com.'}, {'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Namazi', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",European journal of nutrition,['10.1007/s00394-019-02140-z']
714,31556131,"Blood pressure in pregnancy-A stress test for hypertension? Five-year, prospective, follow-up of the ROLO study.","OBJECTIVE


To investigate whether maternal blood pressure (BP) below the diagnostic criteria of hypertensive disorders of pregnancy (HDP) is associated with maternal BP 5 years later.
DESIGN


Prospective, observational study.
SETTING


Dublin, Ireland (2007-2011).
SAMPLE


Three hundred twenty-nine women from the ROLO study (Randomized cOntrol trial of LOw glycaemic index diet to prevent the recurrence of macrosomia).
METHODS


Maternal BP measurements were taken during pregnancy (13, 28 and 34 weeks' gestation and day 1 postpartum) and at the 5-year follow-up. Systolic BP (SBP) and diastolic BP (DBP) were categorized as normal (SBP < 120 and DBP < 80 mm Hg), elevated (SBP 120-129 and DBP < 80 mm Hg), HTN stage 1 (SBP 130-139 or DBP 80-89 mm Hg) or HTN stage 2 (SBP ≥ 140 or DBP ≥ 90 mm Hg) at each timepoint.
MAIN OUTCOME MEASURES


Maternal blood pressure at the 5-year follow-up.
RESULTS


Women with elevated BP at 28 and 34 weeks' gestation had 2.68 (95% CI: 1.36-5.26) and 2.45-fold (95% CI: 1.22-4.95) increased odds of HTN stage 1 respectively, at the 5-year follow-up, compared to those with normal BP in pregnancy.
CONCLUSION


Elevated BP at 28 and 34 weeks' gestation was associated with an increased risk of HTN stage 1 at 5 years later. Thus, raised BP, below the diagnostic criteria of HDP, could be flagged for follow-up postpartum.",2019,"CONCLUSION


Elevated BP at 28 and 34 weeks gestation was associated with an increased risk of HTN stage 1 5 years later.","['Dublin, Ireland (2007-2011', '329 women from the ROLO study', 'hypertensive disorders of pregnancy (HDP']",['LOw glycaemic index diet'],"['recurrence of macrosomia', 'Blood Pressure', 'Systolic BP (SBP) and diastolic BP (DBP', 'Maternal blood pressure at the 5 year follow-up', 'maternal blood pressure (BP']","[{'cui': 'C0454777', 'cui_str': 'Dublin (geographic location)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",329.0,0.112421,"CONCLUSION


Elevated BP at 28 and 34 weeks gestation was associated with an increased risk of HTN stage 1 5 years later.","[{'ForeName': 'Michelle B', 'Initials': 'MB', 'LastName': 'Brady', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Eileen C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Aisling A', 'Initials': 'AA', 'LastName': 'Geraghty', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Amanda U', 'Initials': 'AU', 'LastName': 'Courtney', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Kilbane', 'Affiliation': ""Department of Clinical Chemistry, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Twomey', 'Affiliation': ""Clinical Chemistry, St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Malachi J', 'Initials': 'MJ', 'LastName': 'McKenna', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Crowley', 'Affiliation': 'Department of Endocrinology, St. Vincents University Hospital, Dublin, Ireland.'}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}]",Clinical endocrinology,['10.1111/cen.14102']
715,30218286,"The Effects of Probiotic Honey Consumption on Metabolic Status in Patients with Diabetic Nephropathy: a Randomized, Double-Blind, Controlled Trial.","To the best of our knowledge, this study is the first evaluating the effects of probiotic honey intake on glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress in patients with diabetic nephropathy (DN). This investigation was conducted to evaluate the effects of probiotic honey intake on metabolic status in patients with DN. This randomized, double-blind, controlled clinical trial was performed among 60 patients with DN. Patients were randomly allocated into two groups to receive either 25 g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11 (IBRC-M10791) (10 8  CFU/g) or 25 g/day control honey (n = 30 each group) for 12 weeks. Fasting blood samples were taken at baseline and 12 weeks after supplementation to quantify glycemic status, lipid concentrations, biomarkers of inflammation, and oxidative stress. After 12 weeks of intervention, patients who received probiotic honey compared with the control honey had significantly decreased serum insulin levels (- 1.2 ± 1.8 vs. - 0.1 ± 1.3 μIU/mL, P = 0.004) and homeostasis model of assessment-estimated insulin resistance (- 0.5 ± 0.6 vs. 0.003 ± 0.4, P = 0.002) and significantly improved quantitative insulin sensitivity check index (+ 0.005 ± 0.009 vs. - 0.0007 ± 0.005, P = 0.004). Additionally, compared with the control honey, probiotic honey intake has resulted in a significant reduction in total-/HDL-cholesterol (- 0.2 ± 0.5 vs. + 0.1 ± 0.1, P = 0.04). Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey. Probiotic honey intake had no significant effects on other metabolic profiles compared with the control honey. Overall, findings from the current study demonstrated that probiotic honey consumption for 12 weeks among DN patients had beneficial effects on insulin metabolism, total-/HDL-cholesterol, serum hs-CRP, and plasma MDA levels, but did not affect other metabolic profiles. http://www.irct.ir: IRCT201705035623N115.",2019,"Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey.","['patients with diabetic nephropathy (DN', 'patients with DN', 'Patients with Diabetic Nephropathy', '60 patients with DN']","['Probiotic Honey Consumption', 'probiotic honey intake', '25\xa0g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11']","['serum high-sensitivity C-reactive protein (hs-CRP', 'serum insulin levels', 'quantitative insulin sensitivity check index', 'homeostasis model of assessment-estimated insulin resistance', 'plasma malondialdehyde (MDA) levels', 'metabolic status', 'insulin metabolism, total-/HDL-cholesterol, serum hs-CRP, and plasma MDA levels', 'probiotic honey consumption', 'Fasting blood samples', 'Metabolic Status', 'metabolic profiles', 'glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress', 'glycemic status, lipid concentrations, biomarkers of inflammation, and oxidative stress', 'total-/HDL-cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",60.0,0.0768944,"Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey.","[{'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mazruei Arani', 'Affiliation': 'Department of Food Science and Technology, North Tehran Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Emam-Djomeh', 'Affiliation': 'Department of Food Science, Technology and Engineering Faculty of Agricultural Engineering and Technology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Tavakolipour', 'Affiliation': 'Department of Food Science and Technology, Sabzevar Branch, Islamic Azad University, Sabzevar, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sharafati-Chaleshtori', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9468-x']
716,31870417,"Influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal stone surgery: a prospective, randomized controlled study.","BACKGROUND


We analyzed the influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal surgery (RIRS) in a prospective, randomized controlled study.
METHODS


Seventy patients who underwent RIRS from September 2015 to February 2017 were randomly allocated to general anesthesia (GA) or spinal anesthesia (SA) groups. Renal function was assessed using estimated glomerular filtration rate, and separate renal function was evaluated using nuclear medicine tests. Maneuverability and accessibility were evaluated after every surgery. All procedures were performed by a single experienced surgeon (SY Cho).
RESULTS


Stone-free rate was higher in the GA (92.3%, 36 of 39) than the SA (71.0%, 22 of 31) (P = 0.019) group. Pain score was higher in the GA than in the SA group on the first postoperative morning (P = 0.025), but pain scores of the two groups were similar before discharge (P = 0.560). There were no differences in the changes of serum creatinine level (P = 0.792) and changes of estimated glomerular filtration rate (P = 0.807). Differences of separate renal function between operative and contralateral site increased significantly in patients under GA than under SA at postoperative 3 months (P = 0.014). Maneuverability and accessibility were better in SA with sedation than GA (P < 0.001).
CONCLUSIONS


RIRS under SA showed advantages in renal function change using renogram at postoperative 3 months and in lower pain score on the first postoperative morning. Performance of operator under SA was worse than that under GA and significantly improved with sedation. RIRS under SA showed advantages in lower pain score at postoperative first day.
TRIAL REGISTRATION


Clinicaltrials.gov ID is NCT03957109, and registration date is 17th May 2019. This study was retrospectively registered.",2019,"Pain score was higher in the GA than in the SA group on the first postoperative morning (P = 0.025), but pain scores of the two groups were similar before discharge (P = 0.560).","['retrograde intrarenal stone surgery', 'Seventy patients who underwent RIRS from September 2015 to February 2017']","['general anesthesia (GA) or spinal anesthesia (SA', 'retrograde intrarenal surgery (RIRS', 'anesthesia methods']","['Renal function', 'pain scores', 'glomerular filtration rate, and separate renal function', 'serum creatinine level', 'pain score', 'Performance of operator under SA', 'glomerular filtration rate', 'lower pain score', 'renal function change', 'Pain score', 'Maneuverability and accessibility', 'Stone-free rate', 'surgical outcomes and renal function']","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",70.0,0.101916,"Pain score was higher in the GA than in the SA group on the first postoperative morning (P = 0.025), but pain scores of the two groups were similar before discharge (P = 0.560).","[{'ForeName': 'Ohseong', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Urology, Hallym University Kangnam Sacred Heart Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Man', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Juhyun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Urology, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Min Chul', 'Initials': 'MC', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hwancheol', 'Initials': 'H', 'LastName': 'Son', 'Affiliation': 'Department of Urology, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hyeon', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Seung Hoon', 'Initials': 'SH', 'LastName': 'Ryang', 'Affiliation': 'Department of Urology, Seoul National University Hospital, 101, Daehak-ro Jongno-gu, 03080, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Yong', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Seoul National University Hospital, 101, Daehak-ro Jongno-gu, 03080, Seoul, Republic of Korea. kmoretry@daum.net.'}]",BMC anesthesiology,['10.1186/s12871-019-0901-9']
717,31870451,Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial).,"BACKGROUND


A 2014 Cochrane review evaluating the effect of anabolic steroids after hip fracture concluded that the quality of the studies was insufficient to draw conclusions on the effects and recommended further high-quality trials in the field. Therefore, the aim of this pilot trial is to determine the preliminary effect and feasibility of a 12-week multimodal intervention consisting of physiotherapy (with strength training), protein-rich nutritional supplement and anabolic steroid on knee-extension muscle strength and function 14 weeks after hip fracture surgery.
METHODS


We plan to conduct a randomized, placebo-controlled pilot trial with 48 patients operated for acute hip fracture. The patients are randomized (1:1) to either (1) physiotherapy with protein-rich nutritional supplement plus anabolic steroid or (2) physiotherapy with protein-rich nutritional supplement plus placebo. Outcome assessments will be carried out blinded at baseline (3-10 days after surgery) and at 14 weeks after entering the trial. Primary outcome is the change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb. Secondary outcomes are physical performance test, patient-reported outcomes, and measures of body composition.
DISCUSSION


If the trial is found feasible and the results show an indication of anabolic steroid being a relevant addition to further enhance the recovery of muscle strength and function in an enhanced recovery after surgery program, this trial will constitute the basis of a larger confirmatory trial.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03545347. Preregistered on 4 June 2018.",2019,Primary outcome is the change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb.,"['48 patients operated for acute hip fracture', 'patients with hip fracture']","['physiotherapy with strength training and protein-rich nutritional supplement', 'anabolic steroids', 'physiotherapy (with strength training), protein-rich nutritional supplement and anabolic steroid', 'physiotherapy with protein-rich nutritional supplement plus anabolic steroid or (2) physiotherapy with protein-rich nutritional supplement plus placebo', 'placebo']","['change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb', 'physical performance test, patient-reported outcomes, and measures of body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0002845', 'cui_str': 'Anabolic Steroids'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C2607857'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.15155,Primary outcome is the change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb.,"[{'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Hulsbæk', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark. s_hulsbaek@hotmail.com.'}, {'ForeName': 'Ilija', 'Initials': 'I', 'LastName': 'Ban', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Tobias Kvanner', 'Initials': 'TK', 'LastName': 'Aasvang', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Jens-Erik Beck', 'Initials': 'JB', 'LastName': 'Jensen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section for Surgical Pathophysiology 721, Copenhagen University Hospital, Rigshospitalet Ole Maaløes vej 26, 2100, Copenhagen Ø, Denmark.'}, {'ForeName': 'Nicolai Bang', 'Initials': 'NB', 'LastName': 'Foss', 'Affiliation': 'Department of Anesthesiology, Copenhagen University Hospital, Amager-Hvidovre and Institute of Clinical Medicine, University of Copenhagen, Kettegård Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Morten Tange', 'Initials': 'MT', 'LastName': 'Kristensen', 'Affiliation': 'Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Amager-Hvidovre, Kettegård Alle 30, 2650, Hvidovre, Denmark.'}]",Trials,['10.1186/s13063-019-3845-y']
718,31870456,"Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial.","BACKGROUND


Low back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults.
OBJECTIVE


The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP.
METHODS


A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low, high, and alternating frequency); one control group; and one placebo group. The electroacupuncture will be applied twice a week (30 min per session) for five weeks. The primary clinical outcome measure will be pain intensity. The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed up after six and 12 months to check the medium- and long-term effects.
DISCUSSION


Although electroacupuncture is increasingly used to treat LBP, there is no guidance regarding the parameters used, which leads to inconsistent results. Thus, the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies, especially in the older adult population.
CONCLUSION


This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults. This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03802045. Registered on 14 January 2019.",2019,This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults.,"['older adults with LBP', 'older adult population', 'older adults', '125 participants with non-specific LBP']","['electroacupuncture (EA', 'Electroacupuncture', 'placebo', 'electroacupuncture', 'electroacupuncture frequencies']","['quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors', 'pain intensity', 'chronic low back pain']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]",125.0,0.235527,This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults.,"[{'ForeName': 'Sarina', 'Initials': 'S', 'LastName': 'Francescato Torres', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil. sarinaftorres@usp.br.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Brandt de Macedo', 'Affiliation': 'Department of Physical Therapy Prevention and Rehabilitation, Federal University of Parana, Parana, Brazil.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Dias Antunes', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ingred', 'Initials': 'I', 'LastName': 'Merllin Batista de Souza', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Dimitre Rodrigo Pereira Santos', 'Affiliation': 'Higher Education Unit of the South of Maranhao, Maranhao, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'de Sousa do Espírito Santo', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Ribeiro Jacob', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Torres Cruz', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'de Oliveira Januário', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Amélia', 'Initials': 'A', 'LastName': 'Pasqual Marques', 'Affiliation': 'School of Medicine, Department of Physical Therapy, Speech Therapy and Occupational Therapy, Postgraduate Program in Rehabilitation Sciences, University of Sao Paulo, Sao Paulo, Brazil.'}]",Trials,['10.1186/s13063-019-3813-6']
719,31067131,The impact of aerobic and isometric exercise on different measures of dysfunctional high-density lipoprotein in patients with hypertension.,"BACKGROUND


Exercise training increases high-density lipoprotein (HDL) cholesterol, but its effect on HDL function is unclear. In hypertensives, exercise improves endothelial dysfunction, which is related to HDL function. In the present study, we assess for the first time the effects of different exercise modalities on two cell-free assays of HDL function.
DESIGN


The study was conducted as a prospective randomized controlled trial in 75 hypertensive patients.
METHODS


Patients were randomized in three groups: (a) handgrip isometric training five times weekly; (b) placebo-handgrip; and (c) aerobic exercise training at least three times per week. HDL function was assessed in serum samples at baseline and after 12 weeks of training by two independent assays that determine the proinflammatory phenotype (haptoglobin content) of a specific amount of HDL (Haptoglobin-HDL [HPHDL]) and oxidized HDL (HDLox) as a measure of reduced antioxidant function of HDL. HDL function measures were normalized by the measures of a pooled control of sera from healthy participants and by HDL-C levels (normalized ratio, no units).
RESULTS


Aerobic exercise led to significant reduction of the HDLox from 0.99 ± 0.27 to 0.90 ± 0.29 (no units,  p  = 0.03). The HPHDL did not change in any training group. Changes of HDLox correlated with reduction of the systolic blood pressure only after aerobic exercise ( R  = 0.64,  p  = 0.03).
CONCLUSIONS


Aerobic but not isometric exercise improves the antioxidant function of HDL in patients with hypertension. This improvement correlates positively with reductions of blood pressure.",2019,"RESULTS


Aerobic exercise led to significant reduction of the HDLox from 0.99 ± 0.27 to 0.90 ± 0.29 (no units, p = 0.03).","['Patients', 'patients with hypertension', '75 hypertensive patients']","['handgrip isometric training five times weekly; (b) placebo-handgrip; and (c) aerobic exercise training', 'aerobic and isometric exercise', 'Aerobic but not isometric exercise', 'Exercise training']","['HDL function', 'blood pressure', 'endothelial dysfunction', 'high-density lipoprotein (HDL) cholesterol', 'proinflammatory phenotype (haptoglobin content) of a specific amount of HDL (Haptoglobin-HDL [HPHDL]) and oxidized HDL (HDLox', 'HDL function measures', 'systolic blood pressure', 'antioxidant function of HDL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0585298', 'cui_str': '5x/wk'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",75.0,0.0313721,"RESULTS


Aerobic exercise led to significant reduction of the HDLox from 0.99 ± 0.27 to 0.90 ± 0.29 (no units, p = 0.03).","[{'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pagonas', 'Affiliation': '1 Department of Cardiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'Stergios', 'Initials': 'S', 'LastName': 'Vlatsas', 'Affiliation': '3 Department of Nephrology, Charité - Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Bauer', 'Affiliation': '2 Medical Department I, Marien Hospital Herne, Ruhr-University of Bochum, Germany.'}, {'ForeName': 'Felix S', 'Initials': 'FS', 'LastName': 'Seibert', 'Affiliation': '2 Medical Department I, Marien Hospital Herne, Ruhr-University of Bochum, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sasko', 'Affiliation': '1 Department of Cardiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Buschmann', 'Affiliation': '4 Department of Angiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ritter', 'Affiliation': '1 Department of Cardiology, Medical University of Brandenburg, Germany.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Kelesidis', 'Affiliation': '5 Department of Medicine, David Geffen School of Medicine, University of California, LA, USA.'}, {'ForeName': 'Timm H', 'Initials': 'TH', 'LastName': 'Westhoff', 'Affiliation': '2 Medical Department I, Marien Hospital Herne, Ruhr-University of Bochum, Germany.'}]",European journal of preventive cardiology,['10.1177/2047487319848199']
720,31870458,Comparing the effect of auricular acupressure and body acupressure on pain and duration of the first stage of labor: study protocol for a randomized controlled trial.,"BACKGROUND


Labor pain is one of the leading causes of fear of childbirth. Acupressure is a non-pharmacological pain relief method that has shown promising results in relieving this pain. The present study is designed to compare the effects of body acupressure at multiple points and auricular acupressure on the pain and duration of labor.
METHODS/DESIGN


In a randomized controlled trial, 90 primigravida women who attend for childbirth will be randomly assigned to one of three groups (intervention groups of either body acupressure or auricular acupressure; control, consisting of routine care). Computer-generated six-block randomization techniques will be used to determine the allocation sequence with a 1:1:1 ratio. To hide the allocation, the type of intervention will be written according to the generated sequence and put in opaque envelopes; these as well as questionnaires will be encoded. The pain score for all participants will be measured at the peak uterine contraction at 4-cm cervical dilation and at 10-cm dilation based on a visual analog scale (VAS). The duration of the active phase of labor in these groups will be recorded too. Data will be imported into SPSS-16 software. First, normality of the data distribution will be investigated. To compare labor duration among the research groups, ANOVA will be used, which will be followed, in case of significance, by the Scheffe post hoc test. Furthermore, Chi-squared test will be used to compare the categorized demographic variables and ANOVA or Kruskal-Wallis tests will be used to compare the quantitative variables in the studied groups. A significance level of 0.05 is considered significant.
DISCUSSION


In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials, IRCT20180218038789N1. Registered 2018-03-04; pre result.",2019,"In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared.
",['90 primigravida women who attend for childbirth'],"['auricular acupressure and body acupressure', 'body acupressure or auricular acupressure; control, consisting of routine care', 'body acupressure at multiple points and auricular acupressure', 'Acupressure']","['pain and duration of first stage of labor', 'labor duration', 'pain score', 'pain and duration of labor', 'visual analog scale (VAS', 'duration of the active phase of labor', 'pain and duration of the first stage of labor']","[{'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0474469', 'cui_str': 'Duration of first stage of labor (observable entity)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022871', 'cui_str': 'Labor Stage, First'}]",,0.110726,"In this study the effect of auricular acupressure and body acupressure on pain and duration of first stage of labor will be compared.
","[{'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoradi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Department of midwifery, Mother & Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Science, Front of Mardom Park, Shahid Fahmideh blv., Hamadan, 65178-38698, Iran. Faridehkazemi21@yahoo.com.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Valiani', 'Affiliation': 'Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gorji', 'Affiliation': 'Velayat Clinical & Educational Hospital, Qazvin University of Medical Science, Qazvin, Iran.'}]",Trials,['10.1186/s13063-019-3896-0']
721,31732851,"A single dose of purple grape juice improves physical performance and antioxidant activity in runners: a randomized, crossover, double-blind, placebo study.","PURPOSE


To investigate the effects of a single dose of juice on physical performance, oxidative stress, inflammation and muscle damage in runners.
METHODS


Fourteen recreational male runners (39 ± 9 years, VO 2peak  = 55.9 ± 6.5 ml/kg/min) performed two running tests to exhaustion at 80% of VO 2max  after ingesting grape juice or a placebo drink (10 ml/kg/day) randomly. Blood samples were taken before and 2 h after supplementation and immediately after running to analyze total antioxidant capacity (TAC), malondialdehyde (MDA), alpha-1 acid glycoprotein (A1GPA), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK) and lactate dehydrogenase (LDH).
RESULTS


The participants ran for an average of 59.2 ± 27.8 min until exhaustion in the placebo group and for 68.4 ± 29.7 min until exhaustion in the grape juice intake group, which was a significantly longer time (p = 0.008). This improvement in physical performance was accompanied by a 43.6% increase in TAC (p = 0.000) at the post-exercise timepoint compared to the level at baseline. MDA, A1GPA, hs-CRP, CK, and LDH did not exhibit changes. In contrast, no significant change in any variable was observed after consuming the placebo drink.
CONCLUSION


The single-dose intake of purple grape juice demonstrated an ergogenic effect in recreational runners by increasing run time to exhaustion and increasing antioxidant activity.",2020,This improvement in physical performance was accompanied by a 43.6% increase in TAC (p = 0.000) at the post-exercise timepoint compared to the level at baseline.,"['runners', 'Fourteen recreational male runners (39\u2009±\u20099\xa0years, VO 2peak \u2009=\u200955.9\u2009±\u20096.5\xa0ml/kg/min) performed two', 'recreational runners']","['purple grape juice', 'placebo', 'running tests to exhaustion at 80% of VO 2max  after ingesting grape juice or a placebo drink', 'juice']","['TAC', 'total antioxidant capacity (TAC), malondialdehyde (MDA), alpha-1 acid glycoprotein (A1GPA), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK) and lactate dehydrogenase (LDH', 'physical performance, oxidative stress, inflammation and muscle damage', 'MDA, A1GPA, hs-CRP, CK, and LDH', 'physical performance', 'physical performance and antioxidant activity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439542', 'cui_str': 'Purple color'}, {'cui': 'C0452455', 'cui_str': 'Grape juice (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0029297', 'cui_str': 'alpha 1-Acid Glycoprotein'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C2607857'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.473247,This improvement in physical performance was accompanied by a 43.6% increase in TAC (p = 0.000) at the post-exercise timepoint compared to the level at baseline.,"[{'ForeName': 'Lydiane', 'Initials': 'L', 'LastName': 'de Lima Tavares Toscano', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Alexandre Sérgio', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil. alexandresergiosilva@yahoo.com.br.'}, {'ForeName': 'Ana Carla Lima', 'Initials': 'ACL', 'LastName': 'de França', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Bruno Rafael Virgínio', 'Initials': 'BRV', 'LastName': 'de Sousa', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Eder Jackson Bezerra', 'Initials': 'EJB', 'LastName': 'de Almeida Filho', 'Affiliation': 'Laboratório de Estudos do Treinamento Físico Aplicado ao Desempenho e a Saúde, Departamento de Educação Física, Universidade Federal da Paraíba (UFPB), Centro de Ciências da Saúde, Campus I, Cidade Universitária, João Pessoa, Paraíba, CEP 58059-900, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'da Silveira Costa', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Aline Telles Biasoto', 'Initials': 'ATB', 'LastName': 'Marques', 'Affiliation': 'Empresa Brasileira de Pesquisa Agropecuária, Embrapa Semiárido, Petrolina, Pernambuco, Brazil.'}, {'ForeName': 'Darcilene Fiuza', 'Initials': 'DF', 'LastName': 'da Silva', 'Affiliation': 'Faculdade de Farmácia, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Klécia', 'Initials': 'K', 'LastName': 'de Farias Sena', 'Affiliation': 'Laboratório de Estudos do Treinamento Físico Aplicado ao Desempenho e a Saúde, Departamento de Educação Física, Universidade Federal da Paraíba (UFPB), Centro de Ciências da Saúde, Campus I, Cidade Universitária, João Pessoa, Paraíba, CEP 58059-900, Brazil.'}, {'ForeName': 'Gilberto Santos', 'Initials': 'GS', 'LastName': 'Cerqueira', 'Affiliation': 'Departamento de Morfologia, Universidade Federal do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Conceição Rodrigues Gonçalves', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}]",European journal of nutrition,['10.1007/s00394-019-02139-6']
722,30113928,"Optimal treatment for obsessive compulsive disorder: a randomized controlled feasibility study of the clinical-effectiveness and cost-effectiveness of cognitive-behavioural therapy, selective serotonin reuptake inhibitors and their combination in the management of obsessive compulsive disorder.","Established treatments for obsessive compulsive disorder (OCD) include cognitive behaviour therapy (CBT) and selective serotonin reuptake inhibitor (SSRI) medication. Combined treatment may outperform monotherapy, but few studies have investigated this. A total of 49 community-based adults with OCD were randomly assigned to CBT, SSRI, or SSRI+CBT. Sertraline (50-200 mg/day) was given as the SSRI for 52 weeks. A 16-h-manualized individual CBT was delivered over 8 weeks with four follow-up sessions. Assessors were 'blinded' to treatment allocation. A preliminary health economic evaluation was conducted. At week 16, combined treatment (n=13) was associated with the largest improvement, sertraline (n=7) the next largest and CBT (n=9) the smallest on the observed case analysis. The effect size (Cohen's d) comparing the improvement in Yale Brown Obsessive Compulsive Scale on CBT versus combined treatment was -0.39 and versus sertraline was -0.27. Between 16 and 52 weeks, the greatest clinical improvement was seen with sertraline, but participant discontinuation prevented reliable analysis. Compared with sertraline, the mean costs were higher for CBT and for combined treatment. The mean Quality Adjusted Life Year scores for sertraline were 0.1823 (95% confidence interval: 0.0447-0.3199) greater than for CBT and 0.1135 (95% confidence interval: -0.0290-0.2560), greater than for combined treatment. Combined treatment appeared the most clinically effective option, especially over CBT, but the advantages over SSRI monotherapy were not sustained beyond 16 weeks. SSRI monotherapy was the most cost-effective. A definitive study can and should be conducted.",2018,The mean Quality Adjusted Life Year scores for sertraline were 0.1823 (95% confidence interval: 0.0447-0.3199) greater than for CBT and 0.1135,"['49 community-based adults with OCD', 'obsessive compulsive disorder']","['sertraline', 'Sertraline', 'cognitive-behavioural therapy, selective serotonin reuptake inhibitors', 'CBT, SSRI, or SSRI+CBT', 'cognitive behaviour therapy (CBT) and selective serotonin reuptake inhibitor (SSRI) medication', 'SSRI monotherapy']","['Yale Brown Obsessive Compulsive Scale', 'mean Quality Adjusted Life Year scores', 'mean costs']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",49.0,0.0498641,The mean Quality Adjusted Life Year scores for sertraline were 0.1823 (95% confidence interval: 0.0447-0.3199) greater than for CBT and 0.1135,"[{'ForeName': 'Naomi A', 'Initials': 'NA', 'LastName': 'Fineberg', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Baldwin', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Drummond', 'Affiliation': ""London and St George's Mental Health NHS Trust.""}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Wyatt', 'Affiliation': 'University of Hertfordshire, Hatfield.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Hanson', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Gopi', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Sukhwinder', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Reid', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Virender', 'Initials': 'V', 'LastName': 'Marwah', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Ricky A', 'Initials': 'RA', 'LastName': 'Sachdev', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Pampaloni', 'Affiliation': ""London and St George's Mental Health NHS Trust.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Shahper', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Varlakova', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Davis', 'Initials': 'D', 'LastName': 'Mpavaenda', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Manson', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton.'}, {'ForeName': 'Cliodhna', 'Initials': 'C', 'LastName': ""O'Leary"", 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Irvine', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Deela', 'Initials': 'D', 'LastName': 'Monji-Patel', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Ayotunde', 'Initials': 'A', 'LastName': 'Shodunke', 'Affiliation': 'Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Parkway, Welwyn Garden City.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Dyer', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dymond', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wellsted', 'Affiliation': 'University of Hertfordshire, Hatfield.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000237']
723,31727514,Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort.,"PURPOSE


To understand if a new artificial tear, which is indicated for the treatment of both evaporative and aqueous deficient dry eye, is able to safely alleviate contact lens discomfort (CLD) in symptomatic soft contact lens (CL) wearers.
METHODS


This registered, investigator-masked, two-week, randomized clinical trial recruited adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores. Subjects were randomized to use artificial tears (Systane Complete) before and after CL use or no treatment. Clinical signs (visual acuity, tear breakup time, corneal staining, Schirmer's test I, and meibum quality and expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-reported) were evaluated at baseline and two weeks.
RESULTS


This study recruited 22 subjects who were randomized to artificial tears and 24 subjects who were randomized to no treatment. Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group. No significant between group differences were noted for any clinical signs at two weeks (all p > 0.29). No subject in either group reported any adverse events during the study.
CONCLUSIONS


Systane Complete was found to safely and significantly improve CL comfort in symptomatic CL wearers. Additional work is needed to better understand the mechanism(s) leading to improved comfort since tested clinical signs were unchanged.",2020,Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group.,"['adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores', 'symptomatic soft contact lens (CL) wearers', '22 subjects who were randomized to artificial tears and 24 subjects who were randomized to no treatment', 'Contact Lens Discomfort']",['artificial tears (Systane Complete) before and after CL use or no treatment'],"['clinical signs', 'adverse events', ""Clinical signs (visual acuity, tear breakup time, corneal staining, Schirmer's test I, and meibum quality and expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-reported"", 'CLDEQ-8 scores', 'SPEED scores', 'CL comfort']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]","[{'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C4542395', 'cui_str': 'Systane Complete'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",22.0,0.0508605,Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group.,"[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Pucker', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States. Electronic address: apucker@uab.edu.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Quentin X', 'Initials': 'QX', 'LastName': 'Franklin', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Alanna', 'Initials': 'A', 'LastName': 'Nattis', 'Affiliation': 'Lindenhurst Eye Physicians & Surgeons, P.C., Babylon, NY, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lievens', 'Affiliation': 'Southern College of Optometry, Memphis, TN, United States.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.10.141']
724,31066177,"Incidence, prevalence, and predictors of treatment-resistant hypertension with intensive blood pressure lowering.","Recent guidelines call for more intensive blood pressure (BP)-lowering and a less-stringent treatment-resistant hypertension (TRH) definition, both of which may increase the occurrence of this high-risk phenotype. We performed a post hoc analysis of 11 784 SPRINT and ACCORD-BP participants without baseline TRH, who were randomized to an intensive (<120 mm Hg) or standard (<140 mm Hg) systolic BP target. Incidence, prevalence, and predictors of TRH were compared using the updated definition (requiring ≥4 drugs to achieve BP < 130/80 mm Hg) during intensive treatment, vs the former definition (requiring ≥4 drugs to achieve BP < 140/90 mm Hg) during standard treatment. Incidence/prevalence of apparent refractory hypertension (RFH; uncontrolled BP despite ≥5 drugs) was similarly compared. Overall, 5702 and 6082 patients were included in the intensive and standard treatment cohorts, respectively. Crude TRH incidence using the updated definition under intensive treatment was 30.3 (95% CI, 29.3-31.4) per 100 patient-years, compared with 9.7 (95% CI, 9.2-10.2) using the prior definition under standard treatment. Point prevalence using the prior TRH definition at 1-year was 7.5% in SPRINT and 14% in ACCORD vs 22% and 36%, respectively, with the updated TRH definition. Significant predictors of incident TRH included number of baseline antihypertensive drugs, having diabetes, baseline systolic BP, and Black race. Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years). Implementation of the 2017 hypertension guideline, including lower BP goals for most individuals, is expected to substantially increase treatment burden and incident TRH among the hypertensive population.",2019,Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years).,"['5702 and 6082 patients were included in the intensive and standard treatment cohorts, respectively', '11\xa0784 SPRINT and ACCORD-BP participants without baseline TRH, who were randomized to an intensive (<120\xa0mm\xa0Hg) or standard (<140\xa0mm']",[],"['number of baseline antihypertensive drugs, having diabetes, baseline systolic BP, and Black race', 'Incidence, prevalence, and predictors of treatment-resistant hypertension with intensive blood pressure lowering', 'Crude TRH incidence', 'Hg) systolic BP target', 'Incidence of apparent RFH', 'Incidence, prevalence, and predictors of TRH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}]",,0.131972,Incidence of apparent RFH was also significantly greater using the updated vs prior definition (4.5 vs 1.0 per 100 person-years).,"[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacotherapy & Translational Research, College of Pharmacy, Gainesville, Florida.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes & Biomedical Informatics, College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Almut G', 'Initials': 'AG', 'LastName': 'Winterstein', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, Gainesville, Florida.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Department of Pharmacotherapy & Translational Research, College of Pharmacy, Gainesville, Florida.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13550']
725,30706535,"A pilot study of an integrated mental health, social and medical model for diabetes care in an inner-city setting: Three Dimensions for Diabetes (3DFD).","AIMS


We examined the effectiveness of a service innovation, Three Dimensions for Diabetes (3DFD), that consisted of a referral to an integrated mental health, social care and diabetes treatment model, compared with usual care in improving biomedical and health economic outcomes.
METHODS


Using a non-randomized control design, the 3DFD model was offered in two inner-city boroughs in London, UK, where diabetes health professionals could refer adult residents with diabetes, suboptimal glycaemic control [HbA 1c  ≥ 75 mmol/mol (≥ 9.0%)] and mental health and/or social problems. In the usual care group, there was no referral pathway and anonymized data on individuals with HbA 1c  ≥ 75 mmol/mol (≥ 9.0%) were collected from primary care records. Change in HbA 1c  from baseline to 12 months was the primary outcome, and change in healthcare costs and biomedical variables were secondary outcomes.
RESULTS


3DFD participants had worse glycaemic control and higher healthcare costs than control participants at baseline. 3DFD participants had greater improvement in glycaemic control compared with control participants [-14 mmol/mol (-1.3%) vs. -6 mmol/mol (-0.6%) respectively, P < 0.001], adjusted for confounding. Total follow-up healthcare costs remained higher in the 3DFD group compared with the control group (mean difference £1715, 95% confidence intervals 591 to 2811), adjusted for confounding. The incremental cost-effectiveness ratio was £398 per mmol/mol unit decrease in HbA 1c  , indicating the 3DFD intervention was more effective and costed more than usual care.
CONCLUSIONS


A biomedical, psychological and social criteria-based referral system for identifying and managing high-cost and high-risk individuals with poor glycaemic control can lead to improved health in all three dimensions.",2020,"Total follow-up healthcare costs remained higher in the 3DFD group compared with the control group (mean difference £1715, 95% confidence intervals 591 to 2811), adjusted for confounding.","['adult residents with diabetes, suboptimal glycaemic control [HbA 1c  ≥\xa075\xa0mmol/mol (≥\xa09.0%)] and mental health and/or social problems', '3DFD participants']","['3DFD', 'integrated mental health, social and medical model']","['incremental cost-effectiveness ratio', 'glycaemic control and higher healthcare costs', 'glycaemic control', 'Total follow-up healthcare costs', 'healthcare costs and biomedical variables']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037431', 'cui_str': 'Social Problems'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.0444683,"Total follow-up healthcare costs remained higher in the 3DFD group compared with the control group (mean difference £1715, 95% confidence intervals 591 to 2811), adjusted for confounding.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Britneff', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freudenthal', 'Affiliation': ""Diabetes Centre, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gayle', 'Affiliation': ""Diabetes Centre, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Doherty', 'Affiliation': ""Diabetes Centre, King's College Hospital NHS Foundation Trust, London, UK.""}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.13918']
726,31058457,A self-monitoring urinary salt excretion level measurement device for educating young women about salt reduction: A parallel randomized trial involving two groups.,"To prevent and treat hypertension, it is important to restrict salt in one's diet since adolescence. However, an effective salt-reduction education system has yet to be established. Besides accurate evaluation, we believe that the frequent usage of a measurement device may motivate individuals to avoid high salt intake. The present study evaluated the use of a urinary salt excretion measurement device for salt-reduction education in a parallel randomized trial of two groups. The sample comprised 100 university students who provided consent to participate. A survey with 24-hour home urine collection and blood pressure measurement was conducted. Participants in the self-monitoring group measured their own urinary salt excretion level for 4 weeks, using the self-measurement device. Analyses were conducted on 51 participants in the control group and 49 in the self-monitoring group. At baseline, there was no significant difference between the two groups in terms of their characteristics and 24-hour urinary salt excretion levels. After intervention, 24-hour urinary sodium/potassium ratio showed no change in the control group [baseline score: 4.1 ± 1.5; endline score: 4.2 ± 2.0; P = 0.723], but it decreased significantly in the self-monitoring group [baseline score: 4.0 ± 1.7; endline score: 3.5 ± 1.4; P = 0.044]. This change was significant even after adjusting for baseline and endline differences between groups using analysis of covariance (P = 0.045). The self-monitoring urinary salt excretion measurement device improved the 24-hour urinary sodium/potassium ratio. The device is a useful and practical tool for educating young individuals about dietary salt reduction.",2019,"At baseline, there was no significant difference between the two groups in terms of their characteristics and 24-hour urinary salt excretion levels.","['educating young women about salt reduction', '100 university students who provided consent to participate', '51 participants in the control group and 49 in the self-monitoring group']","['urinary salt excretion measurement device for salt-reduction education', 'self-monitoring urinary salt excretion level measurement device']","['urinary salt excretion level', 'characteristics and 24-hour urinary salt excretion levels', '24-hour urinary sodium/potassium ratio']","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0201808', 'cui_str': 'Excretion measurement (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",51.0,0.0151328,"At baseline, there was no significant difference between the two groups in terms of their characteristics and 24-hour urinary salt excretion levels.","[{'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Yasutake', 'Affiliation': 'Department of Nutritional Sciences, Faculty of Nutritional Sciences, Nakamura Gakuen University, Fukuoka, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Umeki', 'Affiliation': ""Department of Food of Health Sciences, International College of Arts and Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Horita', 'Affiliation': 'Department of Health and Nutrition Sciences, Faculty of Health and Nutrition Sciences, Nishikyushu University, Kanzaki, Japan.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Morita', 'Affiliation': ""Department of Food of Health Sciences, International College of Arts and Sciences, Fukuoka Women's University, Fukuoka, Japan.""}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Murata', 'Affiliation': 'Health Care Center, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ohe', 'Affiliation': 'Health Care Center, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tsuchihashi', 'Affiliation': 'Hypertension Center, Steel Memorial Yawata Hospital, Kitakyushu, Japan.'}, {'ForeName': 'Munechika', 'Initials': 'M', 'LastName': 'Enjoji', 'Affiliation': 'Health Care Center, Fukuoka University, Fukuoka, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13545']
727,30938914,Effect of cryoballoon and radiofrequency ablation for pulmonary vein isolation on left atrial function in patients with nonvalvular paroxysmal atrial fibrillation: A prospective randomized study (Cryo-LAEF study).,"BACKGROUND


Isolation of the pulmonary veins (PVI) has become a mainstay in atrial fibrillation (AFib) therapy. Lesions in left atrial tissue lead to scar formation and this may affect left atrial function.
METHODS


Patients with paroxysmal AFib were randomly assigned in a 1:2 allocation scheme to radiofrequency (RF) ablation or cryoballoon. Real-time three-dimensional echocardiography was performed (under sinus rhythm in all cases) before ablation and at 1 and 3 months to evaluate the left atrial functional indices. The primary outcome measure was change in left atrial ejection fraction (LAEF) at 1 month.
RESULTS


120 patients were randomized (80 to cryoballoon, 40 to RF). The absolute change in LAEF at 1 month was 4.0 (Q1-Q3, -0.1to 7.6)% in the cryoballoon group and -0.8 (Q1-Q3, -1.9 to 0.9)% in the RF group (P < 0.001 for the comparison between groups). At 3 months, the corresponding changes were 6.7 (Q1-Q3, 3.4-11.2)% and 0.7 (Q1-Q3, -0.7 to 3.5)%, respectively (P < 0.001). Overall, the rate of patients with lower LAEF at 3 months compared to baseline was 2.5% in the cryoballoon group and 32.5% in the RF group (P < 0.001). AFib recurrence rate at 6 months was higher in patients with decreased LAEF (odds ratio, 6.2; 95% confidence interval, 2.0-19.5; P = 0.002).
CONCLUSION


The Cryo-LAEF study prospectively compared the effects of RF and cryoballoon ablation on left atrial function. Both at 1 and 3 months postablation, LAEF was either improved or stable in both ablation groups.",2019,"AFib recurrence rate at 6 months was higher in patients with decreased LAEF (odds ratio, 6.2; 95% confidence interval, 2.0-19.5; P = 0.002).
","['patients with nonvalvular paroxysmal atrial fibrillation', '120 patients', 'Patients with paroxysmal AFib']","['RF and cryoballoon ablation', 'cryoballoon and radiofrequency ablation', 'radiofrequency (RF) ablation or cryoballoon']","['rate of patients with lower LAEF', 'AFib recurrence rate', 'absolute change in LAEF', 'change in left atrial ejection fraction (LAEF', 'left atrial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0078995', 'cui_str': 'Atrial Function, Left'}]",120.0,0.058323,"AFib recurrence rate at 6 months was higher in patients with decreased LAEF (odds ratio, 6.2; 95% confidence interval, 2.0-19.5; P = 0.002).
","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannopoulos', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Kossyvakis', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Vrachatis', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Constadina', 'Initials': 'C', 'LastName': 'Aggeli', 'Affiliation': '1st Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsitsinakis', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Letsas', 'Affiliation': '2nd Department of Cardiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tsiachris', 'Affiliation': 'Athens Heart Center, Athens Medical Center, Marousi, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Tsoukala', 'Affiliation': 'Department of Cardiology, Athens General Hospital ""G. Gennimatas"", Athens, Greece.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Efremidis', 'Affiliation': '2nd Department of Cardiology, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Dimosthenis', 'Initials': 'D', 'LastName': 'Katritsis', 'Affiliation': '2nd Department of Cardiology, Hygeia Hospital, Marousi, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Deftereos', 'Affiliation': '1st Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13933']
728,32071470,[Application of β-TCP for bone defect restore after the mandibular third molars extraction: A splitmouth clinical trial].,"OBJECTIVE


To evaluate the effect of bone defect regeneration and the periodontal status of the second molars after mandibular third molars extraction using β-tertiary calcium phosphate (β-TCP) in the test side compared with the spontaneously healed side. To the bone defect of mandibular second molars as a result of surgical removal of impacted mandibular third molars is a common phenomenon, many research shows that the mandibular second molars alveolar bone regeneration was about 1.5 mm and the periodontal pocket >7 mm was greater than 43.3% after mandibular third molars extraction. There has been significant progress researches in the repair of bone defect after the third molar removal, and bone graft filling was one of the effective methods. The bone graft substitutes include autogenous bone, allograft bone, xenograft bone and synthetic bone.
METHODS


A split mouth, randomized clinical study was designed. Fifteen patients with mandibular third molars in the same jaw planned to be extracted were enrolled in the study. One of the sockets of each patient was randomly selected and filled with easy-graftTMCLASSIC (test group). The contralateral socket was left to heal spontaneously (control group). cone beam computed tomography (CBCT) scans were performed the day after the extraction and after 6 months. The horizontal dimensional changes of the sockets were recorded. The newly formed bone volume in the bone was analyzed by CBCT, and the probing depth (PD) was recorded. Student's t test was used to evaluate the difference between the two groups for each parameter, and the P value lower than 0.05 was considered to be statistically significant.
RESULTS


Fifteen patients (30 sockets) completed the flow-up, and all the 30 sockets healed uneventfully. After 6 months' healing, the new bone volume fraction of the test group was 63.3%±2.2%, while the new bone volume fraction of the control group was 50.1%±1.9%. The vertical dimensional increment of the test group was (5.53±0.39) mm, while the vertical change of the control group was (1.53±0.27) mm. The distal buccal site PD of the second molar was (3.0±0.7) mm in the test group, and (6.5±0.8) mm in the control group. Statistically significant differences were detected between the two groups.
CONCLUSION


The randomized controlled clinical trial showed that the application of β-TCP for bone defect repair after the mandibular third molars extraction resulted in more vertical bone regeneration and less probing depth when compared with what was spontaneously healed.",2020,"The vertical dimensional increment of the test group was (5.53±0.39) mm, while the vertical change of the control group was (1.53±0.27) mm.",['Fifteen patients with mandibular third molars in the same jaw planned to be extracted were enrolled in the study'],"['β-TCP', 'β-tertiary calcium phosphate (β-TCP', 'cone beam computed tomography (CBCT) scans']","['distal buccal site PD of the second molar', 'vertical bone regeneration and less probing depth', 'new bone volume fraction', 'autogenous bone, allograft bone, xenograft bone and synthetic bone']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0044091', 'cui_str': 'tenocyclidine-TCP'}, {'cui': 'C0108136', 'cui_str': 'tribasic calcium phosphate'}, {'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0441633'}]","[{'cui': 'C0447321', 'cui_str': 'Distal-buccal (body structure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0522537', 'cui_str': 'Xenografts'}]",15.0,0.0786824,"The vertical dimensional increment of the test group was (5.53±0.39) mm, while the vertical change of the control group was (1.53±0.27) mm.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Wang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
729,31003926,The LEADER trial in type 2 diabetes: Were the characteristics and outcomes of the participants representative?,"AIMS


To compare the characteristics and outcomes of people with type 2 diabetes recruited to the LEADER trial to those of participants in the contemporaneous community-based Fremantle Diabetes Study Phase II (FDS2) who fulfilled LEADER entry criteria.
METHODS


Baseline characteristics of LEADER and LEADER-eligible FDS2 participants were compared using bivariate methods. Incidence rates of the primary (nonfatal myocardial infarction, nonfatal stroke, cardiovascular disease (CVD) death) and other outcomes in the LEADER placebo group were compared with those in LEADER-eligible FDS2 participants during 3.8 years after entry, the median LEADER follow-up.
RESULTS


Of 1551 FDS2 type 2 participants, 323 (20.8%) were LEADER-eligible. Compared with the LEADER sample, they were an average 6 years older, and were less likely to be male, obese and to have prior CVD. There were 3.9 and 2.9 primary outcomes/100 patient-years in LEADER placebo-treated and FDS2 LEADER-eligible patients, respectively. Incidence rates for first myocardial infarction and stroke were 1.9 and 2.1 events/100 patient-years and 1.1 and 1.0 events/100 patient-years, respectively. FDS2 LEADER-eligible patients had a lower CVD death rate of 0.8 versus 1.6/100 patient-years in the LEADER placebo group, but their non-CVD mortality was greater (2.1 versus 1.0/100 patient-years).
CONCLUSIONS


These data suggest recruitment bias in type 2 diabetes CVD outcome trials.",2019,"FDS2 LEADER-eligible patients had a lower CVD death rate of 0.8 versus 1.6/100 patient-years in the LEADER placebo group, but their non-CVD mortality was greater (2.1 versus 1.0/100 patient-years).
","['Of 1551 FDS2 type 2 participants, 323 (20.8%) were LEADER-eligible', 'people with type 2 diabetes recruited to the LEADER trial to those of participants in the contemporaneous community-based Fremantle Diabetes Study Phase II (FDS2) who fulfilled LEADER entry criteria']",['LEADER placebo'],"['Incidence rates', 'Incidence rates of the primary (nonfatal myocardial infarction, nonfatal stroke, cardiovascular disease (CVD) death', 'CVD death rate', 'CVD mortality']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",1551.0,0.265286,"FDS2 LEADER-eligible patients had a lower CVD death rate of 0.8 versus 1.6/100 patient-years in the LEADER placebo group, but their non-CVD mortality was greater (2.1 versus 1.0/100 patient-years).
","[{'ForeName': 'Timothy M E', 'Initials': 'TME', 'LastName': 'Davis', 'Affiliation': 'Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia. Electronic address: tim.davis@uwa.edu.au.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Davis', 'Affiliation': 'Medical School, University of Western Australia, Fremantle Hospital, Fremantle, Western Australia, Australia.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.03.005']
730,31881927,The OMACS-PIL study: a randomised controlled trial within the OMACS observational study.,"BACKGROUND


There has been little research to investigate whether the appearance of paper patient information leaflets (PILs) used to describe research studies to potential participants influences their decision to take part. Embedding a study within a trial (SWAT) is an efficient way of answering this type of methodological question. We included a randomised SWAT within a large cohort study, Outcome Monitoring after Cardiac Surgery (OMACS), to address this question.
METHODS


Potential participants for the OMACS study were randomised to receive one of three PILs, which were identical in content but with varying formatting and use of colour: PIL A (enhanced format), PIL B (hybrid format) and PIL C (standard format). Consent to OMACS was the primary outcome. Consent rates using the three different PIL formats were collected and compared. Qualitative feedback on the different formats was obtained from a public and patient involvement (PPI) group.
RESULTS


For the SWAT, 1517 PILs were sent to potential participants, of whom 640 (42%) consented to take part in OMACS. PIL B had the highest recruitment rate, with 45% of patients consenting to participation; 40% and 41% of patients consented to participation after receiving PILs A and C, respectively. Compared to PIL C, the consent rate was 4% higher with PIL B (45% versus 41%, 95% confidence interval (CI) -2% to + 10%, p = 0.16) and 1% lower with PIL A (40% versus 41%, 95% CI - 7% to + 5%, p = 0.72).
CONCLUSIONS


Consent rates were similar for all three PIL formats. PIL B is being used for the remainder of the host study and will be used to inform the design of PILs for other research studies, as it was the preferred format of the PPI group.
TRIAL REGISTRATION


International Clinical Trials Registry, ISRCTN90204321. Registered on 21 January 2015.",2019,"Compared to PIL C, the consent rate was 4% higher with PIL B (45% versus 41%, 95% confidence interval (CI) -2% to + 10%, p = 0.16) and 1% lower with PIL A (40% versus 41%, 95% CI - 7% to + 5%, p = 0.72).
","[' 1517 PILs were sent to potential participants, of whom 640 (42%) consented to take part in OMACS', 'Potential participants for the OMACS study']","['colour: PIL A (enhanced format), PIL B (hybrid format) and PIL C (standard format', 'Cardiac Surgery (OMACS', 'SWAT']",['consent rate'],"[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]",,0.146049,"Compared to PIL C, the consent rate was 4% higher with PIL B (45% versus 41%, 95% confidence interval (CI) -2% to + 10%, p = 0.16) and 1% lower with PIL A (40% versus 41%, 95% CI - 7% to + 5%, p = 0.72).
","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK. Lucy.Culliford@bristol.ac.uk.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brierley', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Maishman', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Tabusa', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Barney', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit Bristol, Bristol Trials Centre, Translational Health Sciences, Bristol Medical School, Level 7 Queens Building (Zone A), Bristol Royal Infirmary, Bristol, BS2 8HW, UK.'}]",Trials,['10.1186/s13063-019-3958-3']
731,31881928,Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial.,"BACKGROUND


Screening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.
METHODS/DESIGN


The study will enroll at least 510 US women aged 25-64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years. We will randomize participants to an intervention or control arm. The intervention arm will receive kits to self-collect a sample at home and mail it for HPV testing. In both the intervention and control arms, participants will receive assistance in scheduling an appointment for screening in clinic. Study staff will deliver HPV self-collection results by phone and assist in scheduling participants for screening in clinic. The primary outcome is completion of cervical cancer screening. Specifically, completion of screening will be defined as screening in clinic or receipt of negative HPV self-collection results. Women with HPV-negative self-collection results will be considered screening-complete. All other participants will be considered screening-complete if they obtain co-testing or Pap test screening at a study-affiliated institution or other clinic. We will assess whether the self-collection intervention influences participants' perceived risk of cervical cancer and whether perceived risk mediates the relationship between HPV self-collection results and subsequent screening in clinic. We also will estimate the incremental cost per woman screened of offering at-home HPV self-collection kits with scheduling assistance as compared to offering scheduling assistance alone.
DISCUSSION


If mailed self-collection of samples for HPV testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02651883, Registered on 11 January 2016.",2019,"The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.
","['510 US women aged 25-64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years', 'subsequent cervical cancer screening completion among under-screened US women', 'participants for screening in clinic', 'medically underserved women at higher risk of developing cervical cancer', 'human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening']","['human papillomavirus (HPV) self-collection', 'self-collection intervention']","['cervical cancer incidence and mortality', 'completion of cervical cancer screening']","[{'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]","[{'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",,0.072489,"The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening.
","[{'ForeName': 'Lisa P', 'Initials': 'LP', 'LastName': 'Spees', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, 1102-G McGavran-Greenberg, CB7411, Chapel Hill, NC, 27599-7411, USA. lspees21@email.unc.edu.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Des Marais', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, 2103 McGavran-Greenberg, CB7435, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Stephanie B', 'Initials': 'SB', 'LastName': 'Wheeler', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, 1102-G McGavran-Greenberg, CB7411, Chapel Hill, NC, 27599-7411, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Hudgens', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Doughty', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, 2103 McGavran-Greenberg, CB7435, Chapel Hill, NC, 27599-7435, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Smith', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA. jennifers@unc.edu.'}]",Trials,['10.1186/s13063-019-3959-2']
732,30715250,Safety and Efficacy of C-reactive Protein-guided Antibiotic Use to Treat Acute Respiratory Infections in Tanzanian Children: A Planned Subgroup Analysis of a Randomized Controlled Noninferiority Trial Evaluating a Novel Electronic Clinical Decision Algorithm (ePOCT).,"BACKGROUND


The safety and efficacy of using C-reactive protein (CRP) to decide on antibiotic prescription among febrile children at risk of pneumonia has not been tested.
METHODS


This was a randomized (1:1) controlled noninferiority trial in 9 primary care centers in Tanzania (substudy of the ePOCT trial evaluating a novel electronic decision algorithm). Children aged 2-59 months with fever and cough and without life-threatening conditions received an antibiotic based on a CRP-informed strategy (combination of CRP ≥80 mg/L plus age/temperature-corrected tachypnea and/or chest indrawing) or current World Health Organization standard (respiratory rate ≥50 breaths/minute). The primary outcome was clinical failure by day (D) 7; the secondary outcomes were antibiotic prescription at D0, secondary hospitalization, or death by D30.
RESULTS


A total of 1726 children were included (intervention: 868, control: 858; 0.7% lost to follow-up). The proportion of clinical failure by D7 was 2.9% (25/865) in the intervention arm vs 4.8% (41/854) in the control arm (risk difference, -1.9% [95% confidence interval {CI}, -3.7% to -.1%]; risk ratio [RR], 0.60 [95% CI, .37-.98]). Twenty of 865 (2.3%) children in the intervention arm vs 345 of 854 (40.4%) in the control arm received antibiotics at D0 (RR, 0.06 [95% CI, .04-.09]). There were fewer secondary hospitalizations and deaths in the CRP arm: 0.5% (4/865) vs 1.5% (13/854) (RR, 0.30 [95% CI, .10-.93]).
CONCLUSIONS


CRP testing using a cutoff of ≥80 mg/L, integrated into an electronic decision algorithm, was able to improve clinical outcome in children with respiratory infections while substantially reducing antibiotic prescription.
CLINICAL TRIALS REGISTRATION


NCT02225769.",2019,"There were fewer secondary hospitalizations and deaths in the CRP arm: 0.5% (4/865) versus 1.5% (13/854, RR 0.30, 0.100.93).
","['febrile children at risk of pneumonia', 'Tanzanian children', 'children with respiratory infections', 'Children aged 2-59 months with fever and cough and without acutely life-threatening conditions received an', '9 primary care centers in Dar es Salaam, Tanzania (as part of a study evaluating a novel electronic decision algorithm, ePOCT', 'Results\n\n\nFrom December 2014 to February 2016, 1726 children were included']","['C-reactive protein (CRP', 'C-reactive protein-guided antibiotic', 'novel electronic clinical decision algorithm (ePOCT', 'antibiotic based on a CRP-informed strategy (combination of CRP80mg/L plus age/temperature-corrected tachypnea and/or chest indrawing) or current WHO standard (respiratory rate ≥50']","['secondary hospitalizations and deaths', 'safety and efficacy', 'proportion of clinical failure', 'clinical failure by D7; the secondary outcomes were antibiotic prescription at D0, secondary hospitalization or death by D30']","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0002045'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",1726.0,0.381948,"There were fewer secondary hospitalizations and deaths in the CRP arm: 0.5% (4/865) versus 1.5% (13/854, RR 0.30, 0.100.93).
","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Keitel', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Samaka', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Masimba', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Hosiana', 'Initials': 'H', 'LastName': 'Temba', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Said', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kagoro', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Tarsis', 'Initials': 'T', 'LastName': 'Mlaganile', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam, Tanzania.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Sangu', 'Affiliation': 'City Council, Dar es Salaam, Tanzania.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Genton', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': ""D'Acremont"", 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz080']
733,31881990,Two interventions to treat pain disorders and post-traumatic symptoms among Syrian refugees: protocol for a randomized controlled trial.,"BACKGROUND


There is a high prevalence of pain and post-traumatic symptoms among refugees and feasible interventions to manage these are needed. However, knowledge about the effect of physiotherapy and psychological group interventions among refugees is scarce. Our aim is to determine whether two different interventions, the Physiotherapy Activity and Awareness Intervention (PAAI) and Teaching Recovery Techniques (TRT), reduce pain and post-traumatic symptoms among refugees from Syria living in Norway.
METHODS/DESIGN


Syrian adults with either pain disorders or post-traumatic symptoms, or both, will be recruited to this randomized control trial. The trial will include two separate interventions: participants with dominating pain symptoms will be assigned to the PAAI; and those with a predominance of post-traumatic symptoms will be assigned to the TRT intervention. Participants will be randomized to either the immediate intervention group or the delayed intervention group, for each of the interventions (PAAI and TRT). A minimum of 68 participants will be recruited for the PAAI and 78 participants for TRT, in order to detect clinically and statistically significant symptom improvement, assuming 25-30% attrition after recruitment. The main outcomes for the analyses will be pain intensity measured by the Brief Pain Inventory questionnaire and the scores of the Impact of Events Scale - Revised. The effect will be evaluated at the end of interventions lasting 8 weeks (PAAI) and 6 weeks (TRT) using the same instruments after the end of the intervention, and again 4-6 weeks later. Additionally, a qualitative evaluation will be conducted through an embedded process evaluation and personal interviews with participants after each of the interventions is finished.
DISCUSSION


Our study will determine the feasibility of the implementation of two different interventions and the effect of these interventions among refugees from Syria with pain disorders and/or post-traumatic symptoms.
TRIAL REGISTRATION


Clinical Trials.gov, NCT03951909. Retrospectively registered on 19 February 2019.",2019,"Participants will be randomized to either the immediate intervention group or the delayed intervention group, for each of the interventions (PAAI and TRT).","['refugees from Syria living in Norway', 'refugees from Syria with pain disorders and/or post-traumatic symptoms', 'participants with dominating pain symptoms will be assigned to the PAAI; and those with a predominance of post-traumatic symptoms', '68 participants will be recruited for the PAAI and 78 participants for', 'Syrian adults with either pain disorders or post-traumatic symptoms, or both']","['immediate intervention group or the delayed intervention group, for each of the interventions (PAAI and TRT', 'TRT', 'Physiotherapy Activity and Awareness Intervention (PAAI) and Teaching Recovery Techniques (TRT', 'TRT intervention']","['pain and post-traumatic symptoms', 'pain intensity measured by the Brief Pain Inventory questionnaire and the scores of the Impact of Events Scale - Revised']","[{'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0039138', 'cui_str': 'Syria'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3472482', 'cui_str': 'Impact of event scale revised (assessment scale)'}]",68.0,0.18751,"Participants will be randomized to either the immediate intervention group or the delayed intervention group, for each of the interventions (PAAI and TRT).","[{'ForeName': 'Wegdan', 'Initials': 'W', 'LastName': 'Hasha', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway. Wegdan.Hasha@uib.no.'}, {'ForeName': 'Lars T', 'Initials': 'LT', 'LastName': 'Fadnes', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jannicke', 'Initials': 'J', 'LastName': 'Igland', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Vårdal', 'Affiliation': 'Center for Migration Health, Bergen, Norway.'}, {'ForeName': 'Line Merete', 'Initials': 'LM', 'LastName': 'Giusti', 'Affiliation': 'Center for Migration Health, Bergen, Norway.'}, {'ForeName': 'Elisabeth Marie', 'Initials': 'EM', 'LastName': 'Strømme', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Haj-Younes', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Unni', 'Initials': 'U', 'LastName': 'Heltne', 'Affiliation': 'Centre for Crisis Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Bernadette N', 'Initials': 'BN', 'LastName': 'Kumar', 'Affiliation': 'Unit for Migration and Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Diaz', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}]",Trials,['10.1186/s13063-019-3919-x']
734,31881991,Pharmacist-led therapeutic carbohydrate restriction as a treatment strategy for type 2 diabetes: the Pharm-TCR randomized controlled trial protocol.,"BACKGROUND


The current treatment paradigm for type 2 diabetes mellitus (T2D) typically involves use of multiple medications to lower glucose levels in hope of reducing long-term complications. However, such treatment does not necessarily address the underlying pathophysiology of the disease and very few patients achieve partial, complete, or prolonged remission of T2D after diagnosis. The therapeutic potential of nutrition has been highlighted recently based on results of clinical trials reporting remission of T2D with targeted dietary approaches. During the initial phase of such interventions that restrict carbohydrates and/or induce rapid weight loss, hypoglycemia presents a notable risk to patients. We therefore hypothesized that delivering very low-carbohydrate, low-calorie therapeutic nutrition through community pharmacies would be an innovative strategy to facilitate lowering of glycated hemoglobin (A1C) while safely reducing the use of glucose-lowering medications in T2D.
METHODS


A community-based randomized controlled trial that is pragmatic in nature, following a parallel-group design will be conducted (N = 200). Participants will have an equal chance of being randomized to either a pharmacist-led, therapeutic carbohydrate restricted (Pharm-TCR) diet or guideline-based treatment as usual (TAU). Pharm-TCR involves a 12-week very low carbohydrate, calorie-restricted commercial diet plan led by pharmacists and lifestyle coaches with pharmacists responsible for managing medications in collaboration with the participants' family physicians. Main inclusion criteria are diagnosis of T2D, currently treated with glucose-lowering medications, age 30-75 years, and body mass index ≥ 30. The primary outcome is a binary measure of use of glucose-lowering medication. Secondary outcomes include A1C, anthropometrics and clinical blood markers.
DISCUSSION


There are inherent risks involved if patients with T2D who take glucose-lowering medications follow very low carbohydrate diets. This randomized controlled trial aims to determine whether engaging community pharmacists is a safe and effective way to deliver therapeutic carbohydrate restriction and reduce/eliminate the need for glucose-lowering medications in people with T2D.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03181165. Registered on 8 June 2017.",2019,"This randomized controlled trial aims to determine whether engaging community pharmacists is a safe and effective way to deliver therapeutic carbohydrate restriction and reduce/eliminate the need for glucose-lowering medications in people with T2D.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03181165.","['patients with T2D who take glucose-lowering medications follow very low carbohydrate diets', 'Main inclusion criteria are diagnosis of T2D, currently treated with glucose-lowering medications, age 30-75 years, and body mass index ≥\u200930', 'type 2 diabetes mellitus (T2D', 'type 2 diabetes']","['pharmacist-led, therapeutic carbohydrate restricted (Pharm-TCR) diet or guideline-based treatment as usual (TAU', 'Pharmacist-led therapeutic carbohydrate restriction']","['A1C, anthropometrics and clinical blood markers', 'binary measure of use of glucose-lowering medication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet (finding)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.125515,"This randomized controlled trial aims to determine whether engaging community pharmacists is a safe and effective way to deliver therapeutic carbohydrate restriction and reduce/eliminate the need for glucose-lowering medications in people with T2D.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03181165.","[{'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Durrer', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McKelvey', 'Affiliation': 'Institute for Personalized Therapeutic Nutrition, Vancouver, BC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Batterham', 'Affiliation': 'Centre for Rehabilitation, Exercise and Sports Science, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Johnson', 'Affiliation': 'Diabetes Research Group, Life Sciences Institute, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Wortman', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, V1V 1V7, Canada. jonathan.little@ubc.ca.'}]",Trials,['10.1186/s13063-019-3873-7']
735,31881992,"Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study (""EE-Sti.Ve.N"").","BACKGROUND


Febrile urinary tract infection (UTI) is common in infants and needs to be diagnosed quickly. However, the symptoms are non-specific, and diagnosis can only be confirmed after high quality urinalysis. The American Academy of Pediatrics recommends suprapubic aspiration (1-9% contamination) and urinary catheterization (8-14% contamination) for urine collection but both these procedures are invasive. Recent studies have shown a new non-invasive method of collecting urine, bladder stimulation, to be quick and safe. However, few data about bacterial contamination rates have been published for this technique. We hypothesize that the contamination rate of urine collection by bladder stimulation to diagnose febrile UTI in infants under 6 months is equivalent to that of urinary catheterization.
METHODS/DESIGN


This trial aims to assess equivalence in terms of bacterial contamination of urinary samples collected by urinary catheterization and bladder stimulation to diagnose UTI. Seven hundred seventy infants under 6 months presenting with unexplained fever in one of four Pediatric Emergency Departments in France will be enrolled. Each child will be randomized into a bladder stimulation or urinary catheterization group. The primary endpoints will be the validity of the urine sample assessed by the presence of contamination on bacterial culture.
CONCLUSION


A high recruitment rate is achievable due to the high prevalence of suspected UTIs in infants. The medical risk is the same as that for routine clinical care as we analyze patients with isolated fever. If our hypothesis holds true and the rate of urine contamination collected by bladder stimulation is acceptable, the infants included in the study will have benefited from a non-invasive and reliable means of collecting urine.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03801213. Registered on 11 January 2019.",2019,Seven hundred seventy infants under 6 months presenting with unexplained fever in one of four Pediatric Emergency Departments in France will be enrolled.,"['Seven hundred seventy infants under 6\u2009months presenting with unexplained fever in one of four Pediatric Emergency Departments in France will be enrolled', 'patients with isolated fever', 'infants under 6\u2009months']","['bladder stimulation', 'bladder stimulation or urinary catheterization group']","['validity of the urine sample assessed by the presence of contamination on bacterial culture', 'urinary catheterization']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0042019', 'cui_str': 'Urinary Catheterization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture (procedure)'}, {'cui': 'C0042019', 'cui_str': 'Urinary Catheterization'}]",770.0,0.144978,Seven hundred seventy infants under 6 months presenting with unexplained fever in one of four Pediatric Emergency Departments in France will be enrolled.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Demonchy', 'Affiliation': 'Pediatric Emergency Department, Hôpitaux pédiatriques de Nice CHU-Lenval, Nice, France. demonchy.d@pediatrie-chulenval-nice.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ciais', 'Affiliation': 'Pediatric Emergency Department, Hôpitaux pédiatriques de Nice CHU-Lenval, Nice, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, Université Côté d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Berard', 'Affiliation': ""Pediatric Nephrology Unit, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bréaud', 'Affiliation': 'Department of Pediatric Surgery, Hôpitaux pédiatriques de Nice CHU-Lenval, Nice, France.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Rohrlich', 'Affiliation': ""Department of Hematology, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dubos', 'Affiliation': 'Pediatric Emergency Unit and Infectious Diseases, Université de Lille, Centre Hospitalier Universitaire de Lille, Lille, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fortier', 'Affiliation': ""Department of Pediatrics, Centre Hospitalier Général d'Antibes, Antibes, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Desmontils', 'Affiliation': 'Department of Pediatrics, Centre Hospitalier Général de Grasse, Grasse, France.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Hérisse', 'Affiliation': 'Pediatric Emergency Department, Hôpitaux pédiatriques de Nice CHU-Lenval, Nice, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Donzeau', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, Université Côté d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Haas', 'Affiliation': 'Pediatric Emergency Department, Hôpitaux pédiatriques de Nice CHU-Lenval, Nice, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'Pediatric Emergency Department, Hôpitaux pédiatriques de Nice CHU-Lenval, Nice, France.'}]",Trials,['10.1186/s13063-019-3914-2']
736,30985218,The effects of isotretinoin on affective and cognitive functions are disparate in adolescent acne vulgaris patients.,"Background:  The vulnerable brain regions to isotretinoin are represented as hippocampus and prefrontal cortex, involved in mood regulation as well as coordination of cognitive functions. Adolescence is a critical period with dynamic alterations in neurocognition. Isotretinoin brought concerns about its possible effects on executive functions, attention and memory. Objective:  Evaluate the impacts of isotretinoin on neurocognitive functions in adolescents with acne vulgaris and determine the emergence of psychiatric side effects. Materials and methods:  Fifty-five adolescent acne vulgaris patients were assigned to either isotretinoin ( n  = 38) or systemic antibiotic ( n  = 17) groups. The neuropsychological test battery and psychometric tests were performed before treatment and during treatment with 3-months intervals. Results:  Stroop-TBAG form, verbal-auditory digit span, controlled oral word association test and trail making test results improved in the isotretinoin treatment group along with stable scores in the antibiotic group. Children Depression Scale scores of the isotretinoin group showed an increase at 6 th  month compared to baseline. None of the patients was evaluated as depressive by the psychiatric examination. Conclusions:  In a vulnerable age group, our results demonstrate an improvement for neurocognitive functions in isotretinoin patients. The conflicting results suggest distinct mechanisms to be responsible for the effects on affective and cognitive functions.",2020,Children Depression Scale scores of the isotretinoin group showed an increase at 6 th  month compared to baseline.,"['Fifty-five', 'adolescent acne vulgaris patients', 'adolescents with acne vulgaris']","['systemic antibiotic', 'isotretinoin']","['neurocognitive functions', 'Children Depression Scale scores', 'executive functions, attention and memory', 'verbal-auditory digit span, controlled oral word association test and trail making test results', 'affective and cognitive functions']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451069', 'cui_str': 'Child depression scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",55.0,0.0196778,Children Depression Scale scores of the isotretinoin group showed an increase at 6 th  month compared to baseline.,"[{'ForeName': 'Aysenur', 'Initials': 'A', 'LastName': 'Botsali', 'Affiliation': 'School of Medicine, Department of Dermatology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Kocyigit', 'Affiliation': 'School of Medicine, Department of Dermatology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Uran', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Ankara University, Ankara, Turkey.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1606396']
737,30983087,Impact of low-dose prasugrel on platelet reactivity and cardiac dysfunction in acute coronary syndrome patients requiring primary drug-eluting stent implantation: A randomized comparative study.,"OBJECTIVE


The aim of this study was to compare how prasugrel and clopidogrel affect platelet aggregation reactivity, cardiac enzyme release, cardiac remodeling, and the formation of in-stent thrombi after primary percutaneous coronary intervention (PCI).
BACKGROUND


The advantages of using prasugrel over clopidogrel in cardiac injury following acute coronary syndrome (ACS) remain unclear.
METHODS


A total of 78 ACS patients were randomly allocated into clopidogrel (300 mg loading/75 mg maintenance) or prasugrel (20 mg loading/3.75 mg maintenance) treatment groups, followed by undergoing primary PCI. Platelet reactivity and cardiac enzymes were measured before and after primary PCI. Moreover, cardiac function was measured by ultrasound echocardiography and coronary angioscopic observation was after primary PCI up to 8 months later.
RESULTS


Antiplatelet reactivity in the prasugrel treatment group reached optimal levels (P2Y 12  reaction units [PRU] less than 262) immediately after the administration and was maintained even at 8 months, independently of the CYP2C19 genotype. Prasugrel treatment significantly suppressed creatine kinase elevation compared to clopidogrel treatment (median value 404 IU/L to 726 IU/L vs. 189 IU/L to 1,736 IU/L, p = 0.018 for maximum values) and reduced left ventricular mass (217.2-168.8 g in prasugrel, p = 0.045; 196.9-176.4 g in clopidogrel, p = 0.061). There were no significant differences in the incidence of in-stent attached thrombi between the two groups.
CONCLUSIONS


Compared to clopidogrel, prasugrel produced a stable platelet aggregation inhibitory effect in patients with ACS regardless of CYP2C19 genotype, reduced cardiac enzyme release, and prevented cardiac remodeling after ACS.",2020,"Prasugrel treatment significantly suppressed creatine kinase elevation compared to clopidogrel treatment (median value 404 IU/L to 726 IU/L vs. 189 IU/L to 1,736 IU/L, p = 0.018 for maximum values) and reduced left ventricular mass (217.2-168.8 g in prasugrel, p = 0.045; 196.9-176.4 g in clopidogrel, p = 0.061).","['cardiac injury following acute coronary syndrome (ACS', '78 ACS patients', 'acute coronary syndrome patients requiring primary drug-eluting stent implantation']","['prasugrel and clopidogrel', 'prasugrel over clopidogrel', 'low-dose prasugrel', 'Prasugrel', 'prasugrel', 'clopidogrel, prasugrel', 'clopidogrel']","['platelet reactivity and cardiac dysfunction', 'Platelet reactivity and cardiac enzymes', 'left ventricular mass', 'cardiac remodeling', 'cardiac function', 'incidence of in-stent attached thrombi', 'creatine kinase elevation']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0201934', 'cui_str': 'Cardiac enzymes/isoenzymes measurement'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",78.0,0.0449686,"Prasugrel treatment significantly suppressed creatine kinase elevation compared to clopidogrel treatment (median value 404 IU/L to 726 IU/L vs. 189 IU/L to 1,736 IU/L, p = 0.018 for maximum values) and reduced left ventricular mass (217.2-168.8 g in prasugrel, p = 0.045; 196.9-176.4 g in clopidogrel, p = 0.061).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kitano', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tadateru', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Fukamachi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Migita', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Morikawa', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Tamaki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mineki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Murata', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naotaka', 'Initials': 'N', 'LastName': 'Akutsu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mitsumasa', 'Initials': 'M', 'LastName': 'Sudo', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Hiro', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Okumura', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28277']
738,31030594,Evaluation of efficacy and safety of oral terbinafine and itraconazole combination therapy in the management of dermatophytosis.,"Background:  There has been an alarming increase in recalcitrant dermatophytosis in recent years. The standard treatment guidelines no longer seem effective in achieving clearance and results in high failure rates. Objective:  To evaluate the efficacy and safety of oral terbinafine and itraconazole combination therapy in the management of dermatophytosis. Methods:  Clinically diagnosed and KOH positive patients of tinea corporis/cruris/faciei were randomly divided into three groups and given terbinafine 250 mg, itraconazole 200 mg and a combination of both once daily taken on the same day respectively for 3 weeks. Partial responders at the end of the therapy were given same treatment for additional 3 weeks. Clinical parameters namely itching, erythema, and scaling were evaluated at baseline, 3, 6, and 9 weeks. Adverse effects were noted at the end of therapy. Results:  Maximum clinical and mycological cure was achieved in group III (receiving combination therapy) (90%) followed by group II (receiving itraconazole) (50%) and group I (receiving terbinafine) (35%). The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects. Conclusions:  The combination of systemic terbinafine and itraconazole therapy may be an effective and safe therapeutic strategy in the management of dermatophytosis.",2020,"The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects.
",['Clinically diagnosed and KOH positive patients of tinea corporis/cruris/faciei'],"['terbinafine and itraconazole therapy', 'terbinafine and itraconazole combination therapy', 'itraconazole', 'terbinafine 250\u2009mg, itraconazole', 'terbinafine and itraconazole', 'terbinafine']","['Clinical parameters namely itching, erythema, and scaling', 'Adverse effects', 'mycological cure', 'efficacy and safety']","[{'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040252', 'cui_str': 'Tinea corporis (disorder)'}]","[{'cui': 'C0956383', 'cui_str': 'Terbinafine, (Z)-isomer'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1596471', 'cui_str': 'terbinafine 250 MG [Lamisil]'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205467', 'cui_str': 'Mycologic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0174065,"The combination therapy of oral terbinafine and itraconazole was found to be as safe as monotherapy without any significant adverse effects.
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Dermatology, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Mala', 'Initials': 'M', 'LastName': 'Bhalla', 'Affiliation': 'Department of Dermatology, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Gurvinder P', 'Initials': 'GP', 'LastName': 'Thami', 'Affiliation': 'Department of Dermatology, Government Medical College and Hospital, Chandigarh, India.'}, {'ForeName': 'Jagdish', 'Initials': 'J', 'LastName': 'Chander', 'Affiliation': 'Department of Microbiology, Government Medical College and Hospital, Chandigarh, India.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1612835']
739,31030590,Recurrent disease after treatment for cervical pre-cancer: determining whether prophylactic HPV vaccination could play a role in prevention of secondary lesions.,"Existing modalities can effectively treat high-grade cervical intraepithelial neoplasia (CIN) but around 7% of treated women will develop recurrence of CIN grade 2 or above within 2 years of treatment. Post-treatment surveillance is therefore required to detect residual or recurrent disease. Since the implementation of human papillomavirus (HPV) vaccination programs in high-income countries, significant reductions in high-grade CIN have been recorded in vaccinated cohorts who were predominantly HPV-naïve at vaccination. There is still debate as to the extent of potential benefit from vaccination for women previously infected with HPV, given that HPV incidence in women falls with age and previously cleared infection provides at least some protection against reinfection. Whilst vaccination-induced antibodies could prevent type-specific new infections, it is unclear whether vaccination could also prevent reactivation of latent, previously acquired infection and subsequent disease. A review of the available evidence suggests a potential reduction in risk of recurrent disease if women diagnosed and treated for CIN are offered prophylactic vaccines. New modeled analyses and, ideally, a prospectively designed randomized controlled trial in women treated and then randomized to vaccination or placebo would provide much-needed additional evidence to support the effectiveness and cost-effectiveness of offering vaccination to women after treatment for CIN.",2019,Existing modalities can effectively treat high-grade cervical intraepithelial neoplasia (CIN) but around 7% of treated women will develop recurrence of CIN grade 2 or above within 2 years of treatment.,['cervical pre-cancer'],"['prophylactic HPV vaccination', 'placebo']",[],"[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.280169,Existing modalities can effectively treat high-grade cervical intraepithelial neoplasia (CIN) but around 7% of treated women will develop recurrence of CIN grade 2 or above within 2 years of treatment.,"[{'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Velentzis', 'Affiliation': 'Cancer Research Division, Cancer Council NSW , Sydney , NSW , Australia.'}, {'ForeName': 'J M L', 'Initials': 'JML', 'LastName': 'Brotherton', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne , Melbourne , VIC , Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Canfell', 'Affiliation': 'Cancer Research Division, Cancer Council NSW , Sydney , NSW , Australia.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2019.1600500']
740,30998121,Efficacy and safety of 20% albumin fluid loading in healthy subjects: a comparison of four resuscitation fluids.,"Recently, buffered salt solutions and 20% albumin (small volume resuscitation) have been advocated as an alternative fluid for intravenous resuscitation. The relative comparative efficacy and potential adverse effects of these solutions have not been evaluated. In a randomized, double blind, cross-over study of six healthy male subjects we compared the pulmonary and hemodynamic effects of intravenous administration of 30 ml/kg of 0.9% saline, Hartmann's solution and 4% albumin, and 6 ml/kg of 20% albumin (albumin dose equivalent). Lung tests (spirometry, ultrasound, impulse oscillometry, diffusion capacity, and plethysmography), two- to three-dimensional Doppler echocardiography, carotid applanation tonometry, blood gases, serum/urine markers of endothelial, and kidney injury were measured before and after each fluid bolus. Data were analyzed with repeated measures ANOVA with effect of fluid type examined as an interaction. Crystalloids caused lung edema [increase in ultrasound B line ( P  = 0.006) and airway resistance ( P  = 0.009)], but evidence of lung injury [increased angiopoietin-2 ( P  = 0.019)] and glycocalyx injury [increased syndecan ( P  = 0.026)] was only observed with 0.9% saline. The colloids caused greater left atrial stretch, decrease in lung volumes, and increase in diffusion capacity than the crystalloids, but without pulmonary edema. Stroke work increased proportionally to increase in preload with all four fluids ( R 2  = 0.71). There was a greater increase in cardiac output and stroke volume after colloid administration, associated with a reduction in afterload. Hartmann's solution did not significantly alter ventricular performance. Markers of kidney injury were not affected by any of the fluids administrated. Bolus administration of 20% albumin is both effective and safe in healthy subjects.  NEW & NOTEWORTHY  Bolus administration of 20% albumin is both effective and safe in healthy subjects when compared with other commonly available crystalloids and colloidal solution.",2019,"The colloids caused greater left atrial stretch, decrease in lung volumes, and increase in diffusion capacity than the crystalloids, but without pulmonary edema.","['six healthy male subjects', 'healthy subjects']","['buffered salt solutions and 20% albumin (small volume resuscitation', '20% albumin', '20% albumin fluid loading', ""intravenous administration of 30 ml/kg of 0.9% saline, Hartmann's solution and 4% albumin, and 6 ml/kg of 20% albumin (albumin dose equivalent""]","['lung volumes', 'Lung tests (spirometry, ultrasound, impulse oscillometry, diffusion capacity, and plethysmography), two- to three-dimensional Doppler echocardiography, carotid applanation tonometry, blood gases, serum/urine markers of endothelial, and kidney injury', 'airway resistance', 'afterload', 'diffusion capacity', 'cardiac output and stroke volume', 'Efficacy and safety', 'left atrial stretch', 'lung edema', 'ventricular performance', 'ultrasound B line', 'glycocalyx injury [increased syndecan']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0013125'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0013520', 'cui_str': 'Echocardiography, Doppler'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0034063', 'cui_str': 'Wet Lung'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0061622', 'cui_str': 'Cell Coat'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0075691'}]",6.0,0.197963,"The colloids caused greater left atrial stretch, decrease in lung volumes, and increase in diffusion capacity than the crystalloids, but without pulmonary edema.","[{'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Ubbo F', 'Initials': 'UF', 'LastName': 'Wiersema', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Perry', 'Affiliation': 'College of Medicine and Public Health, Flinders University , Adelaide, South Australia , Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schembri', 'Affiliation': 'Department of Respiratory Medicine, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Bouchier', 'Affiliation': 'College of Medicine and Public Health, Flinders University , Adelaide, South Australia , Australia.'}, {'ForeName': 'Dani', 'Initials': 'D', 'LastName': 'Dixon', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Wong', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Bersten', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre , Bedford Park, South Australia , Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01058.2018']
741,31724083,"Açai pulp supplementation as a nutritional strategy to prevent oxidative damage, improve oxidative status, and modulate blood lactate of male cyclists.","PURPOSE


Açai pulp is a source of phytochemicals and has been associated with antioxidant, anti-inflammatory, and antigenotoxic effects. This study aimed to assess the effects of açai pulp consumption on oxidative, inflammatory, and aerobic capacity markers of cyclist athletes.
RESEARCH METHODS AND PROCEDURES


A crossover, randomized, placebo-controlled, single-blind study was developed with ten male cyclists (33.5 ± 4.7 years old, body mass index of 23.9 ± 1.38 kg/m 2 , and training load around 1875 ± 238 AU/week). The athletes consumed 400 g/day of pasteurized açai pulp (AP) or placebo (PL) for 15 days, with a 30-day wash-out period between trials. Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT) were evaluated before and after each intervention. Data were analyzed using a linear regression model with mixed effects (p ≤ 0.05).
RESULTS


Increased serum antioxidant capacity (p = 0.006) and decreased lipid peroxidation (p = 0.01) were observed in subjects after intervention with AP. Blood lactate levels during effort significantly decreased (by 29%, p = 0.025) and ATi increased (p = 0.006) after AP. No significant effect on DNA damage was attributed to AP consumption.
CONCLUSION


We found notable effects of AP intervention on antioxidant status in athletes. Both the reduction in blood lactate concentration and increase in ATi during the effort suggest an overall improvement in the aerobic capacity of the cyclists, confirming that AP consumption may influence variables associated with performance in endurance athletes.",2020,"Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT) were evaluated before and after each intervention.","['endurance athletes', 'cyclist athletes', 'ten male cyclists (33.5\u2009±\u20094.7\xa0years old, body mass index of 23.9\u2009±\u20091.38\xa0kg/m 2 , and training load around 1875\u2009±\u2009238 AU/week', 'male cyclists', 'athletes']","['placebo', 'açai pulp consumption', 'Açai pulp supplementation', 'AP intervention', 'pasteurized açai pulp (AP) or placebo (PL']","['antioxidant status', 'DNA damage', 'blood lactate concentration', 'Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT', 'Blood lactate levels', 'oxidative, inflammatory, and aerobic capacity markers', 'lipid peroxidation', 'serum antioxidant capacity']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4517620', 'cui_str': '1875'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0751980', 'cui_str': 'Gel Electrophoresis, Single-Cell'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.120809,"Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT) were evaluated before and after each intervention.","[{'ForeName': 'Sara Ivone Barros Morhy', 'Initials': 'SIBM', 'LastName': 'Terrazas', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, FCF UNESP, Rodovia Araraquara Jaú, km 01\xa0s/n, Araraquara, São Paulo, 14800-903, Brazil.'}, {'ForeName': 'Bryan Steve Martinez', 'Initials': 'BSM', 'LastName': 'Galan', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, FCF UNESP, Rodovia Araraquara Jaú, km 01\xa0s/n, Araraquara, São Paulo, 14800-903, Brazil.'}, {'ForeName': 'Flávia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, EEFERP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Vinicius Paula', 'Initials': 'VP', 'LastName': 'Venancio', 'Affiliation': 'School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, FCFRP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Lusânia Maria Greggi', 'Initials': 'LMG', 'LastName': 'Antunes', 'Affiliation': 'School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, FCFRP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Papoti', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, EEFERP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Maricely Janette Uria', 'Initials': 'MJU', 'LastName': 'Toro', 'Affiliation': 'Center of Natural Sciences and Technology, State University of Pará, UEPA, Travessa Dr. Enéas Pinheiro, no 2626, Belém, Pará, 66095-015, Brazil.'}, {'ForeName': 'Iuri Ferreira', 'Initials': 'IF', 'LastName': 'da Costa', 'Affiliation': 'Center of Natural Sciences and Technology, State University of Pará, UEPA, Travessa Dr. Enéas Pinheiro, no 2626, Belém, Pará, 66095-015, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'de Freitas', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, FCF UNESP, Rodovia Araraquara Jaú, km 01\xa0s/n, Araraquara, São Paulo, 14800-903, Brazil. ellenfreitas@usp.br.'}]",European journal of nutrition,['10.1007/s00394-019-02138-7']
742,31022555,"Heterogeneity of Treatment Effects in a Randomized Trial of Literacy-Adapted Group Cognitive-Behavioral Therapy, Pain Psychoeducation, and Usual Medical Care for Multiply Disadvantaged Patients With Chronic Pain.","Differences among patients can moderate the impact of evidence-based treatments (ie, heterogeneity of treatment effects), leading patients to get more or less benefit. The Learning About My Pain study was a randomized, comparative effectiveness trial of a 10-week literacy-adapted group cognitive-behavioral therapy for chronic pain (CBT) versus pain psychoeducation groups (EDU) versus usual medical care. We examined potential sociodemographic and cognitive moderators of treatment effect among participants with post-treatment assessments (N = 241). Analyses were conducted using moderation in the PROCESS macro in SPSS and significant interactions were explored further. Education and primary literacy moderated the difference between CBT and EDU on pain intensity, and primary literacy, health literacy, and working memory moderated the difference between CBT and EDU on pain interference. Analyses revealed few significant moderation effects relative to usual medical care. No moderators were identified for depression. Neither sex nor minority status moderated any differences between groups. Patients with lower education, literacy, and working memory gained more benefit from CBT than EDU. When provided sufficient guidance and structure in a way that is meaningfully adapted, highly disadvantaged patients achieved as much benefit as less disadvantaged patients, suggesting that the literacy-adapted CBT more successfully met the needs of this population. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01967342 PERSPECTIVE: This article presents findings related to heterogeneity of treatment effects for simplified group psychosocial treatments for chronic pain. The results suggest that educationally, cognitively, or literacy disadvantaged patients benefit most from the more structured approach of literacy-adapted CBT rather than EDU, whereas less disadvantaged patients benefit from either treatment.",2019,"Education and primary literacy moderated the difference between CBT and EDU on pain intensity, and primary literacy, health literacy, and working memory moderated the difference between CBT and EDU on pain interference.","['participants with post-treatment assessments (N\u202f=\u202f241', 'chronic pain', 'Multiply Disadvantaged Patients With Chronic Pain']","['Literacy-Adapted Group Cognitive-Behavioral Therapy, Pain Psychoeducation, and Usual Medical Care', 'pain psychoeducation groups (EDU) versus usual medical care', '10-week literacy-adapted group cognitive-behavioral therapy']","['pain intensity, and primary literacy, health literacy, and working memory moderated the difference between CBT and EDU on pain interference']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C1719797', 'cui_str': 'Multiply'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0386724,"Education and primary literacy moderated the difference between CBT and EDU on pain intensity, and primary literacy, health literacy, and working memory moderated the difference between CBT and EDU on pain interference.","[{'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Van Dyke', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, Alabama. Electronic address: bpvandyke@crimson.ua.edu.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Calia A', 'Initials': 'CA', 'LastName': 'Moraís', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Science, Rush University Medical Center, Chicago, Illinois; Department of Anesthesiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Eyer', 'Affiliation': 'Capstone College of Nursing, The University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, The University of Alabama, Tuscaloosa, Alabama.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.04.006']
743,31658111,Effectiveness of the virtual reality on cognitive function of children with hemiplegic cerebral palsy: a single-blind randomized controlled trial.,"Cerebral palsy is a term covering non-progressive motor and cognitive impairments caused by lesions of the brain. This study aims to evaluate the effectiveness of virtual reality-based rehabilitation program for children with hemiplegic cerebral palsy on cognitive functions. Ninety children (47 boys, 43 girls) with hemiplegic cerebral palsy were randomized to either study (n = 45; 11.18 ± 3.37 years) or control (n = 45; 11.06 ± 3.24 years) groups. The study group received virtual reality intervention in addition to Traditional Occupational Therapy intervention, and the control group received Traditional Occupational Therapy for 20 sessions. Both groups were evaluated by blinded assessors with Dynamic Occupational Therapy Cognitive Assessment for Children to collect information on cognitive functioning. Both groups' cognitive functions were improved after 10 weeks of interventions. The between-group comparison revealed significantly greater improvements in all subtest of cognitive functions in the virtual reality group than in the Traditional Occupational Therapy group (P < 0.001). Our results showed that 10 weeks of virtual reality-based rehabilitation enhanced cognitive functions in children with hemiplegic cerebral palsy. Using virtual reality applications in cognitive rehabilitation was recommended to improve spatial perception, praxis, visuomotor construction and thinking operations in children with cerebral palsy.",2020,Our results showed that 10 weeks of virtual reality-based rehabilitation enhanced cognitive functions in children with hemiplegic cerebral palsy.,"['children with hemiplegic cerebral palsy on cognitive functions', 'children with cerebral palsy', 'Ninety children (47 boys, 43 girls) with hemiplegic cerebral palsy', 'children with hemiplegic cerebral palsy']","['virtual reality intervention in addition to Traditional Occupational Therapy intervention, and the control group received Traditional Occupational Therapy', 'virtual reality-based rehabilitation', 'virtual reality-based rehabilitation program', 'virtual reality', 'Dynamic Occupational Therapy Cognitive Assessment']","['cognitive function', 'cognitive functions', 'spatial perception, praxis, visuomotor construction and thinking operations', 'subtest of cognitive functions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",90.0,0.0285749,Our results showed that 10 weeks of virtual reality-based rehabilitation enhanced cognitive functions in children with hemiplegic cerebral palsy.,"[{'ForeName': 'Orkun Tahir', 'Initials': 'OT', 'LastName': 'Aran', 'Affiliation': 'Hacettepe University Faculty of Health Sciences, Occupational Therapy, Ankara.'}, {'ForeName': 'Sedef', 'Initials': 'S', 'LastName': 'Şahin', 'Affiliation': 'Hacettepe University Faculty of Health Sciences, Occupational Therapy, Ankara.'}, {'ForeName': 'Barkin', 'Initials': 'B', 'LastName': 'Köse', 'Affiliation': 'Hacettepe University Faculty of Health Sciences, Occupational Therapy, Ankara.'}, {'ForeName': 'Zeynep Bahadir', 'Initials': 'ZB', 'LastName': 'Ağce', 'Affiliation': 'Üsküdar University Faculty of Health Sciences, Occupational Therapy, İstanbul, Turkey.'}, {'ForeName': 'Hülya', 'Initials': 'H', 'LastName': 'Kayihan', 'Affiliation': 'Hacettepe University Faculty of Health Sciences, Occupational Therapy, Ankara.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000378']
744,30753384,Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness.,"BACKGROUND


Effective therapeutics for respiratory viruses are needed. Early data suggest that nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness.
METHODS


From March 2014 through March 2017, a double-blind, placebo-controlled trial was conducted in 260 participants ≥1 year old hospitalized with influenza-like illness at 6 hospitals in Mexico. Participants were randomized 1:1 to NTZ (age ≥12 years, 600 mg twice daily; age 4-11 years and 1-3 years, 200 or 100 mg twice daily, respectively) or placebo for 5 days in addition to standard of care. The primary endpoint was time from first dose to hospital discharge. Influenza reverse-transcription polymerase chain reaction and Respifinder 22 multiplex test were used for virus detection.
RESULTS


Of 260 participants enrolled, 257 were randomized and took at least 1 dose of study treatment (intention-to-treat population): 130 in the NTZ group and 127 in the placebo group. The Kaplan-Meier estimate of the median duration of hospitalization was 6.5 (interquartile range [IQR], 4.0-9.0) days in the NTZ group vs 7.0 (IQR, 4.0-9.0) days in the placebo group (P = .56). Duration of hospitalization between the 2 treatments was similar in children (P = .29) and adults (P = .62), influenza A and B (P = .32), and other respiratory viruses. Seven (5.4%) and 6 (4.7%) participants in the NTZ and placebo groups, respectively, reported serious adverse events.
CONCLUSIONS


Treatment with NTZ did not reduce the duration of hospital stay in severe influenza-like illness. Further analyses based on age and evaluations by virus did not reveal any subgroups that appeared to benefit from NTZ.
CLINICAL TRIALS REGISTRATION


NCT02057757.",2019,"Duration of hospitalization between the two treatments was similar in children (P=0.29) and adults (P=0.62), influenza A and B (P=0.32) and other respiratory viruses.","['260 participants ≥ 1 year old hospitalized with influenza-like illness at six hospitals in Mexico', 'Severe Acute Respiratory Illness', '260 participants enrolled, 257 were randomized and took at least one dose of study treatment (ITT population): 130 in the NTZ group and 127 in the']","['placebo', 'nitazoxanide', 'NTZ and placebo', 'NTZ', 'Nitazoxanide (NTZ', 'Nitazoxanide']","['time from first dose to hospital discharge', 'median duration of hospitalization', 'severe adverse events', 'duration of hospital stay', 'Efficacy and Safety', 'Duration of hospitalization']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C1436435', 'cui_str': 'NTZ'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",260.0,0.687629,"Duration of hospitalization between the two treatments was similar in children (P=0.29) and adults (P=0.62), influenza A and B (P=0.32) and other respiratory viruses.","[{'ForeName': 'Ana E', 'Initials': 'AE', 'LastName': 'Gamiño-Arroyo', 'Affiliation': 'Hospital Infantil de México ""Dr Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'M Lourdes', 'Initials': 'ML', 'LastName': 'Guerrero', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Social and Scientific Systems, Inc, Silver Spring, Maryland.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Ramírez-Venegas', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias, Mexico City.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Llamosas-Gallardo', 'Affiliation': 'Instituto Nacional de Pediatría, Mexico City.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Galindo-Fraga', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Sarbelio', 'Initials': 'S', 'LastName': 'Moreno-Espinosa', 'Affiliation': 'Hospital Infantil de México ""Dr Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Roldán-Aragón', 'Affiliation': 'Hospital General ""Dr Aurelio Valdivieso,"" Oaxaca, Mexico.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Araujo-Meléndez', 'Affiliation': 'Hospital Central ""Dr Ignacio Morones-Prieto,"" San Luis Potosi, Mexico.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Ibarra-González', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Martínez-López', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'García-Andrade', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kapushoc', 'Affiliation': 'Social and Scientific Systems, Inc, Silver Spring, Maryland.'}, {'ForeName': 'H Preston', 'Initials': 'HP', 'LastName': 'Holley', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Smolskis', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz100']
745,31000233,Can front-of-pack nutrition labeling influence children's emotional associations with unhealthy food products? An experiment using emoji.,"Food products targeted at children are usually marketed using persuasive elements aimed at creating positive hedonic and emotional associations. For this reason, changes in children's emotional associations with unhealthy food products can discourage their consumption. In this context, the aim of the present study was to compare children's emotional associations with food products featuring different front-of-pack (FOP) nutrition labelling schemes. A total of 492 children (6-12 years old) were randomly divided into three groups, each of which evaluated a series of packages featuring different FOP nutrition labelling schemes: guidelines daily amount (GDA), traffic light system (TLS) and nutritional warnings. For each of the six packages and three unpackaged products, children were asked to select all the emoji from a list that described how they would feel eating the product. Data were analyzed using generalized linear models. FOP nutrition labelling significantly influenced the frequency of use five of the 16 emoji. In general, children who evaluated packages with directive and semi-directive schemes used emoji associated with positive emotions less frequently than those who evaluated packages with the GDA system. The effect of FOP nutrition labelling scheme on emotional associations was moderated by age and type of school. The effect of directive and semi-directive FOP nutritional schemes, in special nutritional warnings, tended to be higher for younger children and children from public schools. These results suggest that FOP nutrition labelling may contribute to discouraging consumption of products with high content of nutrients associated with non-communicable diseases among children.",2019,"In general, children who evaluated packages with directive and semi-directive schemes used emoji associated with positive emotions less frequently than those who evaluated packages with the GDA system.","[""children's emotional associations with food products featuring different front-of-pack (FOP) nutrition labelling schemes"", '492 children (6-12\u202fyears old', 'younger children and children from public schools']","['FOP nutrition labelling schemes: guidelines daily amount (GDA), traffic light system (TLS) and nutritional warnings', 'directive and semi-directive FOP nutritional schemes', 'FOP nutrition labelling scheme']",['emotional associations'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0442664', 'cui_str': 'Traffic light (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",492.0,0.0253156,"In general, children who evaluated packages with directive and semi-directive schemes used emoji associated with positive emotions less frequently than those who evaluated packages with the GDA system.","[{'ForeName': 'Mayara', 'Initials': 'M', 'LastName': 'Lima', 'Affiliation': 'Food Technology Department, Technology Institute, Federal Rural University of Rio de Janeiro, Rodovia BR 456, km 7, Seropédica, RJ, Brazil. Electronic address: mayaralima@ufrrj.br.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'de Alcantara', 'Affiliation': 'PDJ CNPq/Embrapa Agroindústria de Alimentos, Avenida das Américas, 29501, CEP 23020-470 Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Inayara B A', 'Initials': 'IBA', 'LastName': 'Martins', 'Affiliation': 'Food Technology Department, Technology Institute, Federal Rural University of Rio de Janeiro, Rodovia BR 456, km 7, Seropédica, RJ, Brazil.'}, {'ForeName': 'Gastón', 'Initials': 'G', 'LastName': 'Ares', 'Affiliation': 'Sensometrics & Consumer Science, Instituto Polo Tecnológico de Pando, Facultad de Química, Universidad de la República, By Pass de Rutas 8 y 101 s/n, Pando, Uruguay.'}, {'ForeName': 'Rosires', 'Initials': 'R', 'LastName': 'Deliza', 'Affiliation': 'Embrapa Agroindústria de Alimentos, Avenida das Américas, 29501, CEP 23020-470 Rio de Janeiro, RJ, Brazil.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.02.027']
746,31715582,Individualized Training Based on Force-Velocity Profiling During Jumping in Ballet Dancers.,"PURPOSE


Ballet dancers are required to achieve performance feats such as exciting and dramatic elevations. Dancers with a greater jump height can perform a wider range of skills during their flight time and implement more specific technical skills related to the aesthetic components of a dance choreography. New findings suggest the relationship between force and velocity mechanical capabilities (F-V profile) as an important variable for jumping performance. A new field method based on several series of loaded vertical jumps provides information on the theoretical maximal force, theoretical maximal velocity, theoretical maximal power, and the imbalance between force and velocity (F-VIMB). The purpose of this study was to observe the effects of 9 wk of individualized F-V profile-based training during countermovement jumps (CMJs) in female ballet dancers.
METHODS


CMJ and mechanical outputs of 46 dancers (age = 18.9 [1.1] y, body mass = 54.8 [6.1] kg, height = 163.7 [8.4] cm) were estimated in a pre-post intervention. The control group (10 participants) continued with the standardized training regimen (no resistance training), whereas the experimental group (36 participants) performed 2 sessions over 9 wk of a training plan based on their F-V profile.
RESULTS


The experimental group presented significant differences with large effect sizes in CMJ height (29.3 [3.2] cm vs 33.5 [3.72] cm), theoretical maximal force (24.1 [2.2] N/kg vs 29.9 [2.8] N/kg), and theoretical maximal velocity (4 [0.6] m/s vs 3.2 [0.5] m/s). Significant differences with a very large effect size were found in F-VIMB (43.8% [15.3%] vs 24.9% [8.7%]).
CONCLUSION


A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.",2020,A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.,"['female ballet dancers', '46 dancers (age ']","['individualized F-V profile-based training during countermovement jumps (CMJs', 'standardized training regimen (no resistance training', 'Individualized Training Based on Force-Velocity Profiling']","['theoretical maximal force', 'F-VIMB', 'CMJ height']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0335081', 'cui_str': 'Dancer (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]",36.0,0.0246706,A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.,"[{'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Escobar Álvarez', 'Affiliation': ''}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Fuentes García', 'Affiliation': ''}, {'ForeName': 'Filipe A', 'Initials': 'FA', 'LastName': 'Da Conceição', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0492']
747,30998422,Clinical assessment of topical erythromycin gel with and without zinc acetate for treating mild-to-moderate acne vulgaris.,"Purpose:  Erythromycin is an effective topical antibiotic for treating mild-to-moderate inflammatory acne vulgaris, especially papules acne during puberty as well as papules - pustular acne in adult women. Erythromycin is a macrolide antibiotic that has long been used as a topical dosage form to treat acne. It has favorable effects in resolving inflammatory acne lesions not only by reducing Propioni bacterium acnes density, but also by directly inhibiting neutrophil chemotactic factors and reactive oxygen species (ROS) production. Zinc, a metallic element has bacteriostatic activity against Propioni bacterium acnes. Combining zinc with antibiotic (erythromycin) can reduce antibiotic resistance and increase antibiotic absorption in-to the skin. Material and methods:  In the present study, erythromycin (2% w/v) with zinc acetate (1.2% w/v) as 'topical gel' and erythromycin (2% w/v) gel alone were evaluated for treating mild to moderate inflammatory acne vulgaris. This double-blind study was carried out on 102 patients 13-25 years of age, divided into two groups. The group A received erythromycin and group B received erythromycin with zinc acetate topical gels during 3 weeks. Acne grading and lesion counts for comedones, papules and pustules were performed during each visit zero, first, second and third weeks. Results:  Erythromycin treatment (with zinc acetate) gel showed to be more effective than erythromycin (alone) gel with respect to reducing the number of acne lesions and severity grade of acne.Number of lesions and severity of acne were significantly reduced at the end of 3rd week in both groups ( p  < .001).  Conclusions:  In conclusion, it can be stated that erythromycin with and without zinc acetate was clinically effective, and both formulations produced a significant reductions in acne grading as well as inflamed and noninflamed lesion counts ( p  < .000). Statistically, there was no significant difference between formulation A and B.",2020,gel showed to be more effective than erythromycin (alone) gel with respect to reducing the number of acne lesions and severity grade of acne.,"['mild-to-moderate inflammatory acne vulgaris, especially papules acne during puberty as well as papules - pustular acne in adult women', 'treating mild-to-moderate acne vulgaris', '102 patients 13-25 years of age, divided into two groups']","['Combining zinc with antibiotic (erythromycin', ""topical gel' and erythromycin"", 'zinc acetate', 'Erythromycin', 'topical erythromycin gel with and without zinc acetate', 'erythromycin', 'erythromycin with zinc acetate topical gels', 'Erythromycin treatment (with zinc acetate']","['antibiotic resistance and increase antibiotic absorption', 'Number of lesions and severity of acne', 'Acne grading and lesion counts for comedones, papules and pustules', 'number of acne lesions and severity grade of acne']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0263443', 'cui_str': 'Pustular acne (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C0149368', 'cui_str': 'Zinc Acetate'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0221228', 'cui_str': 'Comedone (disorder)'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0241157', 'cui_str': 'Pustule (morphologic abnormality)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",102.0,0.0755926,gel showed to be more effective than erythromycin (alone) gel with respect to reducing the number of acne lesions and severity grade of acne.,"[{'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Sayyafan', 'Affiliation': 'Department of Pharmaceutics School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ramzi', 'Affiliation': 'Department of Pharmaceutics School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Rahmatollah', 'Initials': 'R', 'LastName': 'Salmanpour', 'Affiliation': 'Department of Dermatology School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2019.1606394']
748,31719675,Longitudinal neovascular changes on optical coherence tomography angiography in proliferative diabetic retinopathy treated with panretinal photocoagulation alone versus with intravitreal conbercept plus panretinal photocoagulation: a pilot study.,"PURPOSE


To investigate the longitudinal changes in neovascularization of the retinal elsewhere (NVE) size on optical coherence tomography angiography (OCTA) in proliferative diabetic retinopathy (PDR) treated by panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP.
METHODS


A prospective pilot study. Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included. They were assigned to receive PRP alone (PRP group) or intravitreal conbercept injection plus PRP (combination group). Ophthalmic examinations, including BCVA and OCTA to measure the NVE size, were performed at baseline before each PRP session, and at 1, 3, and 6 months.
RESULTS


Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group. There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline. In both groups, there was a significant (P < 0.05) NVE size reduction during the majority of study visits, with the reduction observed in the combination group significantly larger than that in the PRP group. No significant BCVA changes were observed in either groups, except that in the PRP group, the BCVA at 3 months was significantly improved (P < 0.05). No deaths or unexpected adverse events (AEs) were reported.
CONCLUSIONS


Intravitreal conbercept plus PRP was more effective than PRP monotherapy in NVE regression. Precise quantification of the NVE area by OCTA makes it a useful tool for monitoring the response of retinal neovascular lesions to the therapy.",2020,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","['proliferative diabetic retinopathy treated with', 'Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included', 'proliferative diabetic retinopathy (PDR', 'Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group']","['optical coherence tomography angiography', 'intravitreal conbercept plus panretinal photocoagulation', 'PRP alone (PRP group) or intravitreal conbercept injection plus PRP', 'panretinal photocoagulation alone', 'panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP', 'optical coherence tomography angiography (OCTA']","['No deaths or unexpected adverse events (AEs', 'NVE size reduction', 'BCVA changes', 'BCVA and OCTA to measure the NVE size', 'BCVA']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0430878', 'cui_str': 'Retinal angiography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",44.0,0.0175467,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. yuweihongeye@foxmail.com.'}]","Eye (London, England)",['10.1038/s41433-019-0628-3']
749,30981618,Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial.,"OBJECTIVE


The aim of this randomized controlled trial was to evaluate the safety and efficacy of neodymium: yttrium aluminum garnet laser treatment of lichen sclerosus (LS) by comparing it with topical corticosteroid treatment.
METHODS


A total of 40 female patients with vulvar LS were randomized 1:1 into a study (laser) group and a control (topical corticosteroids) group. The laser group received three laser treatments. Blinded evaluators evaluated biopsies and graded improvement on clinical photographs at baseline and at 3 months. Patients graded the intensity of symptoms on a 0 to 10 visual analogue scale at baseline and 1-, 3-, and 6-month follow-up. Patients also rated the tolerability of laser treatments, and side effects were monitored. (Canadian Task Force classification I) RESULTS: Laser treatment discomfort was on average 1.5 of 10 on the visual analogue scale. At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group. At 6-month follow-up, the improvement of symptoms in the laser group was still significant. The correct order of photographs (before and after treatment) was assigned significantly more often in the laser-treated patients compared with the control group.
CONCLUSION


Laser therapy for LS caused minimal patient discomfort during the treatment, with no adverse effects, and demonstrated better efficacy than in the control group, with significant improvement lasting up to 6 months. Laser therapy is a promising option for patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use.",2019,"At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group.","['patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use', 'Lichen Sclerosus', '40 female patients with vulvar LS']","['Non-ablative Laser Therapy', 'control (topical corticosteroids', 'Laser therapy', 'neodymium: yttrium aluminum garnet laser treatment']","['Laser treatment discomfort', 'safety and efficacy', 'minimal patient discomfort', 'tolerability of laser treatments, and side effects', 'LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction', 'intensity of symptoms on a 0 to 10 visual analogue scale', 'improvement of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0023652', 'cui_str': 'Lichen Sclerosus'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",40.0,0.0832864,"At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group.","[{'ForeName': 'Urška', 'Initials': 'U', 'LastName': 'Bizjak Ogrinc', 'Affiliation': 'Gynecology Clinic Juna, Ljubljana, Slovenia. Electronic address: urska.bizjak-ogrinc@juna.si.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Senčar', 'Affiliation': 'Gynecology Clinic Juna, Ljubljana, Slovenia.'}, {'ForeName': 'Boštjan', 'Initials': 'B', 'LastName': 'Luzar', 'Affiliation': 'Institute of Pathology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Adolf', 'Initials': 'A', 'LastName': 'Lukanović', 'Affiliation': 'Department of Gynecology, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2019.01.023']
750,30926298,Durability of the neutralizing antibody response to vaccine and non-vaccine HPV types 7 years following immunization with either Cervarix® or Gardasil® vaccine.,"Bivalent (Cervarix®) and quadrivalent (Gardasil®) Human Papillomavirus (HPV) vaccines demonstrate remarkable efficacy against the targeted genotypes, HPV16 and HPV18, but also a degree of cross-protection against non-vaccine incorporated genotypes, HPV31 and HPV45. These outcomes seem to be supported by observations that the HPV vaccines induce high titer neutralizing antibodies against vaccine types and lower responses against non-vaccine types. Few data are available on the robustness of the immune response against non-vaccine types. We examined the durability of vaccine and non-vaccine antibody responses in a follow up of a head-to-head study of 12-15 year old girls initially randomized to receive three doses of Cervarix® or Gardasil® vaccine. Neutralizing antibodies against both vaccine and non-vaccine types remained detectable up to 7 years following initial vaccination and a mixed effects model was used to predict the decline in antibody titers over a 15 year period. The decline in vaccine and non-vaccine type neutralizing antibody titers over the study period was estimated to be 30% every 5-7 years, with Cervarix® antibody titers expected to remain 3-4 fold higher than Gardasil® antibody titers over the long term. The antibody decline rates in those with an initial response to non-vaccine types were similar to that of vaccine types and are predicted to remain detectable for many years. Empirical data on the breadth, magnitude, specificity and durability of the immune response elicited by the HPV vaccines contribute to improving the evidence base supporting this important public health intervention. Original trial: ClinicalTrials.gov NCT00956553.",2019,Neutralizing antibodies against both vaccine and non-vaccine types remained detectable up to 7 years following initial vaccination and a mixed effects model was used to predict the decline in antibody titers over a 15 year period.,['a follow up of a head-to-head study of 12-15\u202fyear old girls'],"['vaccine and non-vaccine HPV', 'Cervarix® or Gardasil® vaccine', 'vaccine and non-vaccine antibody responses', 'Bivalent (Cervarix®) and quadrivalent (Gardasil®) Human Papillomavirus (HPV) vaccines']","['antibody titers', 'antibody decline rates']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1721789', 'cui_str': 'Cervarix'}, {'cui': 'C1721787', 'cui_str': 'Gardasil'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.0318268,Neutralizing antibodies against both vaccine and non-vaccine types remained detectable up to 7 years following initial vaccination and a mixed effects model was used to predict the decline in antibody titers over a 15 year period.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Godi', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Panwar', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Haque', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK.'}, {'ForeName': 'Clementina E', 'Initials': 'CE', 'LastName': 'Cocuzza', 'Affiliation': 'Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Andrews', 'Affiliation': 'Statistics, Modelling and Economics Department, Public Health England, London, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Southern', 'Affiliation': 'Immunisation and Countermeasures Public Health England, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Section of Paediatrics, Imperial College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': 'Immunisation and Countermeasures Public Health England, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Beddows', 'Affiliation': 'Virus Reference Department, Public Health England, London, UK. Electronic address: simon.beddows@phe.gov.uk.'}]",Vaccine,['10.1016/j.vaccine.2019.03.052']
751,30907769,Improving Coping Styles in Family Caregivers of Psychiatric Inpatients Using Planned Behavior Problem-Solving Training.,"BACKGROUND


The consequences and high costs of psychiatric disorders impact family caregivers greatly. Health services should identify and provide accessible support programs to facilitate effective caregiver coping.
PURPOSE


The aim of this study was to determine the effectiveness of a theory-of-planned-behavior-based problem-solving training program on the coping styles of family caregivers of psychiatric inpatients.
METHODS


In this two-group, randomized control trial, 72 family caregivers were randomly assigned to either a control group receiving standard care or an intervention group receiving a training program (eight sessions over 4 weeks). Demographic information was recorded at baseline, and the Coping Inventory for Stressful Situations was administered to both groups at baseline, immediately postintervention, and 1-month follow-up.
RESULTS


Immediately after the intervention, the intervention group earned significantly higher task-oriented coping style scores (mean difference = 5.03, p = .015) than the control group, but no significant difference was detected between the two groups for either emotion- or avoidance-oriented coping style scores. At 1-month follow-up, the intervention group earned significantly higher scores than the control group for task-oriented (mean difference = 8.56, p < .001) and emotion-oriented (mean difference = 7.14, p = .002) coping styles. No improvement in avoidance-oriented coping style at the postintervention or follow-up time points was detected.
CONCLUSIONS


Implementation by nurses and other health professionals of problem-solving training programs that are based on the theory of planned behavior is recommended to strengthen the use of task- and emotion-oriented approaches that help family caregivers of psychiatric patients better cope with stress.",2020,"At 1-month follow-up, the intervention group earned significantly higher scores than the control group for task-oriented (mean difference = 8.56, p < .001) and emotion-oriented (mean difference = 7.14, p = .002) coping styles.","['Family Caregivers of Psychiatric Inpatients Using', 'family caregivers of psychiatric inpatients', '72 family caregivers']","['Planned Behavior Problem-Solving Training', 'control group receiving standard care or an intervention group receiving a training program', 'theory-of-planned-behavior-based problem-solving training program']","['emotion- or avoidance-oriented coping style scores', 'Demographic information', 'avoidance-oriented coping style', 'higher task-oriented coping style scores']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric inpatient'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0543432', 'cui_str': 'Problem solving training (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",72.0,0.0323256,"At 1-month follow-up, the intervention group earned significantly higher scores than the control group for task-oriented (mean difference = 8.56, p < .001) and emotion-oriented (mean difference = 7.14, p = .002) coping styles.","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abedi', 'Affiliation': 'BSN, RN, Master Student, Student Research Center, Faculty of Nursing & Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mousa', 'Initials': 'M', 'LastName': 'Alavi', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ghazavi', 'Affiliation': 'MSN, RN, Lecturer, Nursing & Midwifery Care Research Center, Faculty of Nursing & Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Visentin', 'Affiliation': 'PhD, Senior Lecturer, College of Health and Medicine, University of Tasmania, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cleary', 'Affiliation': 'PhD, RN, Professor, College of Health and Medicine, University of Tasmania, Sydney, NSW, Australia.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000320']
752,30968559,Clinical outcomes at 2 years of the Absorb bioresorbable vascular scaffold versus the Xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease-AIDA trial substudy.,"BACKGROUND


Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS.
METHODS AND RESULTS


We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17).
CONCLUSION


In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.",2020,"There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17).
","['patients presenting with acute coronary syndrome versus stable coronary disease-AIDA trial substudy', 'treated patients presenting either with or without ACS', 'Patients with acute coronary syndrome (ACS']","['Absorb bioresorbable vascular scaffold versus the Xience drug-eluting metallic stent', 'Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES']","['definite or probable device thrombosis', 'Definite or probable device thrombosis', 'rate of the 2-year primary endpoint of target vessel failure (TVF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.04951,"There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17).
","[{'ForeName': 'Ruben Y G', 'Initials': 'RYG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'The Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Kraak', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'The Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Sjoerd H', 'Initials': 'SH', 'LastName': 'Hofma', 'Affiliation': 'The Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'E Karin', 'Initials': 'EK', 'LastName': 'Arkenbout', 'Affiliation': 'The Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands.'}, {'ForeName': 'Auke P J D', 'Initials': 'APJD', 'LastName': 'Weevers', 'Affiliation': 'The Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Laura S M', 'Initials': 'LSM', 'LastName': 'Kerkmeijer', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'NHLI, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Marcel A M', 'Initials': 'MAM', 'LastName': 'Beijk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Karel T', 'Initials': 'KT', 'LastName': 'Koch', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'M Marije', 'Initials': 'MM', 'LastName': 'Vis', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28193']
753,30907035,Effect of acupuncture at Neiguan point combined with amiodarone therapy on early recurrence after pulmonary vein electrical isolation in patients with persistent atrial fibrillation.,"OBJECTIVE


Early atrial fibrillation (AF) recurrences are common and have been shown to predict AF recurrences late after AF ablation during follow-up. Neiguan point acupuncture has been recognized to be therapeutic in treating AF in clinical practice.
METHODS AND RESULTS


Eighty-five patients were enrolled in succession due to persistent AF. All patients were randomized divided into control group and acupuncture group. In the control group (n = 45), amiodarone was orally taken from the first day after pulmonary vein isolation (PVI). In the acupuncture group (n = 40), patients were treated with Neiguan point acupuncture for 7 days and amiodarone was prescribed as same as the control group after PVI. The levels of inflammatory factors were analyzed before operation, 1 week after the operation and 3 months later. After 3 months, the acupuncture group had a lower rate of early recurrences than the control group (5/40 [12.5%] vs 15/45 [33.3%], P = 0.039). The inflammatory factors level in the two groups were significantly increased after ablation. However, compared with the control group, the levels of TNF-α, IL-6, CRP, TGF-β1, MMP2 in the acupuncture group significantly lower (P < 0.05). In a multivariate analysis, acupuncture was an independent factor associated with a lower rate of early recurrences during the blanking period (odds ratio, 0.17; 95% confidence interval, 0.05-0.63; P = 0.008).
CONCLUSION


Neiguan point acupuncture combined with amiodarone is superior to amiodarone alone in reducing early recurrences of patients with persistent AF after PVI. The efficacy of Neiguan acupuncture therapy on the early recurrence is associated with the decreased inflammation factors.",2019,"In a multivariate analysis, acupuncture was an independent factor associated with a lower rate of early recurrences during the blanking period (odds ratio, 0.17; 95% confidence interval, 0.05-0.63; P = 0.008).
","['Eighty-five patients were enrolled in succession due to persistent AF', 'patients with persistent AF after PVI', 'Early atrial fibrillation', 'patients with persistent atrial fibrillation']","['amiodarone', 'Neiguan point acupuncture', 'Neiguan acupuncture therapy', 'acupuncture', 'amiodarone therapy']","['levels of TNF-α, IL-6, CRP, TGF-β1, MMP2', 'inflammatory factors level', 'levels of inflammatory factors', 'rate of early recurrences']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C4303555', 'cui_str': 'Amiodarone therapy (procedure)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",85.0,0.0451316,"In a multivariate analysis, acupuncture was an independent factor associated with a lower rate of early recurrences during the blanking period (odds ratio, 0.17; 95% confidence interval, 0.05-0.63; P = 0.008).
","[{'ForeName': 'Junkui', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Shengbo', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Weihai Municipal Hospital, Weihai, Henan.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, Fuwai Central China Cardiovascular Hospital, Henan Provincial Peoples Hospital, Zhengzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhibing', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Huangfen', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Congxin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13924']
754,31808295,Clinical outcomes after TAVR with heparin or bivalirudin as periprocedural anticoagulation in patients with and without peripheral arterial disease: Results from the BRAVO-3 randomized trial.,"OBJECTIVES


This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO-3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH).
BACKGROUND


PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH.
METHODS


BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE.
RESULTS


The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in-hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days.
CONCLUSIONS


Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications.",2020,"No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD.","['119 patients with PAD', 'patients with or without PAD', 'Patients with PAD undergoing', 'patients undergoing transcatheter aortic valve replacement (TAVR', '31 centers, n = 802', 'patients with and without peripheral artery disease (PAD', 'patients with and without peripheral arterial disease']","['TAVR with heparin or bivalirudin', 'bivalirudin versus UFH', 'bivalirudin', 'bivalirudin versus unfractionated heparin (UFH', 'transfemoral TAVR', 'Bivalirudin']","['Vascular complications', 'rates of minor vascular complications', 'Major adverse cardiovascular events (MACE', 'mortality, NACE, MACE, major bleeding or CVA', 'risk of any major adverse events', '30-day death, myocardial infarction, or cerebrovascular accidents (CVA', 'risk of minor vascular complications', 'Net adverse cardiovascular events (NACE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",119.0,0.247024,"No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zilberszac', 'Affiliation': 'Department of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Chandiramani', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hengstenberg', 'Affiliation': 'Department of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schafer', 'Affiliation': 'Department of Cardiology, University Heart Center, Hamburg, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Department of General and Interventional Cardiology, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Violini', 'Affiliation': 'Interventional Cardiology Unit, San Camillo Hospital, Rome, Italy.'}, {'ForeName': 'Raban', 'Initials': 'R', 'LastName': 'Jeger', 'Affiliation': 'Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Department of Cardiology and INSERM UMR 1011, University Hospital and CHRU Lille, Lille, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boekstegers', 'Affiliation': 'Department of Cardiology, Helios Heart Center Siegburg, Siegburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hambrecht', 'Affiliation': 'Department of Cardiology, Klinikum Links der Weser, Bremen, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tron', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumenteil', 'Affiliation': 'Department of General and Interventional Cardiology, Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Department of Cardiology, Universität Leipzig, Herzzentrum, Leipzig, Germany.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'PLx Pharma Inc., Sparta, New Jersey.'}, {'ForeName': 'Prodromos', 'Initials': 'P', 'LastName': 'Anthopoulos', 'Affiliation': 'Division of Cardiology, The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28642']
755,32410922,Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography (People CT Trial).,"Aim


To evaluate the performance of three contrast media (CM) injection protocols for cardiac computed tomography angiography (CCTA) based on body weight (BW), lean BW (LBW), and cardiac output (CO).  Materials and methods . A total of 327 consecutive patients referred for CCTA were randomized into one of the three CM injection protocols, where CM injection was based on either BW (112 patients), LBW (108 patients), or CO (107 patients). LBW and CO were calculated via formulas. All scans were ECG-gated and performed on a third-generation dual-source CT with 70-120 kV (automated tube voltage selection) and 100 kV qual.ref /330 mAs qual.ref . CM injection protocols were also adapted to scan time and tube voltage. The primary outcome was the proportion of patients with optimal intravascular attenuation (325-500 HU). Secondary outcomes were mean and standard deviation of intravascular attenuation values (HU), contrast-to-noise ratio (CNR), and subjective image quality with a 4-point Likert scale (1 = poor/2 = sufficient/3 = good/4 = excellent). The  t -test for independent samples was used for pairwise comparisons between groups, and a chi-square test ( χ 2) was used to compare categorical variables between groups. All  p  values were 2-sided, and a  p  < 0.05 was considered statistically significant.
Results


Mean overall HU and CNR were 423 ± 60HU/14 ± 3 (BW), 404 ± 62HU/14 ± 3 (LBW), and 413 ± 63HU/14 ± 3 (CO) with a significant difference between groups BW and LBW ( p =0.024). The proportion of patients with optimal intravascular attenuation (325-500 HU) was 83.9%, 84.3%, and 86.9% for groups BW, LBW, and CO, respectively, and between-group differences were small and nonsignificant. Mean CNR was diagnostic (≥10) in all groups. The proportion of scans with good-excellent image quality was 94.6%, 86.1%, and 90.7% in the BW, LBW, and CO groups, respectively. The difference between proportions was significant between the BW and LBW groups.
Conclusion


Personalization of CM injection protocols based on BW, LBW, and CO, and scan time and tube voltage in CCTA resulted in low variation between patients in terms of intravascular attenuation and a high proportion of scans with an optimal intravascular attenuation. The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.",2020,The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.,['327 consecutive patients referred for CCTA'],['three contrast media (CM) injection protocols for cardiac computed tomography angiography (CCTA'],"['mean and standard deviation of intravascular attenuation values (HU), contrast-to-noise ratio (CNR), and subjective image quality with a 4-point Likert scale', 'proportion of patients with optimal intravascular attenuation', 'LBW and CO', 'proportion of scans with good-excellent image quality', 'body weight (BW), lean BW (LBW), and cardiac output (CO', 'Mean CNR', 'Mean overall HU and CNR', 'BW, LBW, and CO, and scan time and tube voltage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]",327.0,0.0186532,The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.,"[{'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Eijsvoogel', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'B M F', 'Initials': 'BMF', 'LastName': 'Hendriks', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mihl', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Willigers', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Martens', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Das', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center+, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, Netherlands.'}]",Contrast media & molecular imaging,['10.1155/2020/5407936']
756,31821654,Randomised clinical trial of group-based physiotherapy in extremely low birthweight children with minimal/mild motor impairment: A preliminary study.,"AIM


Extremely low birthweight infants often present with mild neurodevelopmental impairments in gross motor function and postural stability in early childhood. The aim of the study was to undertake a randomised controlled trial to determine the short- and longer-term effects of group-based physiotherapy compared to standard care on performance in extremely low birthweight children with minimal/mild impairment.
METHODS


Fifty children aged 4 years, born <28 weeks gestation and/or birthweight <1000 g with minimal/mild motor impairment were enrolled in a randomised controlled trial and randomly allocated to 6 weeks of group-based intervention (n = 24) or standard care (n = 26). The intervention consisted of a combination of traditional physiotherapy and task-oriented approaches of approximately 1 h in duration and varied according to each child's strengths and weaknesses. Baseline, post intervention and 1 year post baseline assessments included Movement Assessment Battery for Children-2 (MABC-2), single leg stance, lateral reach and long jump.
RESULTS


Forty-eight (96%) children completed the study, which demonstrated no significant differences between the intervention and standard care groups on any of the assessments. Both groups improved initially from baseline to initial reassessment on the MABC-2 (P < 0.001). For both groups, however, MABC-2 manual dexterity, aiming/catching and total score declined from baseline to 1 year follow-up. However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
CONCLUSIONS


There were no differences in outcomes between groups. Both approaches may contribute to improved short-term performance and longer-term improvements on functional skills in extremely preterm children.",2020,"However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
","['Forty-eight (96', 'extremely low birthweight children with minimal/mild impairment', 'extremely preterm children', 'Fifty children aged 4\u2009years, born <28\u2009weeks gestation and/or birthweight <1000\u2009g with minimal/mild motor impairment', 'extremely low birthweight children with minimal/mild motor impairment']","['group-based physiotherapy', 'standard care']","['functional skills', 'single leg stance and limb strength', 'MABC-2 manual dexterity, aiming/catching and total score', 'MABC-2', 'Movement Assessment Battery for Children-2 (MABC-2), single leg stance, lateral reach and long jump']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]",50.0,0.176483,"However, for both groups, single leg stance and limb strength were significantly improved from baseline to 1 year follow-up.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}, {'ForeName': 'Yvonne R', 'Initials': 'YR', 'LastName': 'Burns', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Watter', 'Affiliation': 'School of Health and Rehabilitation, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kristen S', 'Initials': 'KS', 'LastName': 'Gibbons', 'Affiliation': 'Mater Research Institute, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gray', 'Affiliation': 'Growth and Development Unit, Mater Health Services, Brisbane, Queensland, Australia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14712']
757,30777293,"Direct effects of cognitive therapy skill acquisition on cognitive therapy skill use, idiosyncratic dysfunctional beliefs and emotions in distressed individuals: An experimental study.","Experimental studies that manipulate treatment procedures to investigate their direct effects on treatment processes and outcomes are necessary to find out the effective elements and improve the effects of cognitive behavioral therapy (CBT) for depression. The present study randomized mildly to severely depressed participants into a procedure focused on cognitive therapy skill acquisition (CTSA; n = 27) or a control procedure focused on being exposed to theories of automatic thinking (n = 25) and investigated the direct effects on cognitive therapy (CT) skill use, credibility of idiosyncratic dysfunctional beliefs and strength of emotions. After the procedure, participants were exposed to a sad mood induction and given an assignment to test their CT skills. Participants who received the CTSA procedure used more CT skills compared to participants that received the control procedure, but there were no differences between conditions in the decrease of the credibility of idiosyncratic dysfunctional beliefs and strength of emotions. However, in participants with mild levels of depression, those who underwent the CTSA procedure showed larger decrease in the credibility of their most malleable belief (i.e. mostly automatic negative thoughts) compared to those who received the control procedure, but the significance of these findings disappeared when controlling for differences in ratings of the procedures. Future experimental studies should focus on the effects of CT skill training in the long term, the dose of the procedure and individual patient differences to find out under what circumstances the use of CT skills can lead to a reduction in dysfunctional thinking and subsequent symptoms of depression.",2020,"Participants who received the CTSA procedure used more CT skills compared to participants that received the control procedure, but there were no differences between conditions in the decrease of the credibility of idiosyncratic dysfunctional beliefs and strength of emotions.","['distressed individuals', 'severely depressed participants into a procedure focused on']","['cognitive behavioral therapy (CBT', 'CT skill training', 'CTSA procedure', 'cognitive therapy skill acquisition', 'cognitive therapy skill acquisition (CTSA; n\u202f=\u202f27) or a control procedure focused on being exposed to theories of automatic thinking']","['cognitive therapy (CT) skill use, credibility of idiosyncratic dysfunctional beliefs and strength of emotions', 'credibility of their most malleable belief', 'cognitive therapy skill use, idiosyncratic dysfunctional beliefs and emotions', 'CT skills', 'credibility of idiosyncratic dysfunctional beliefs and strength of emotions']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.0192855,"Participants who received the CTSA procedure used more CT skills compared to participants that received the control procedure, but there were no differences between conditions in the decrease of the credibility of idiosyncratic dysfunctional beliefs and strength of emotions.","[{'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands. Electronic address: s.j.e.bruijniks@vu.nl.'}, {'ForeName': 'Sander A', 'Initials': 'SA', 'LastName': 'Los', 'Affiliation': 'Department of Cognitive Psychology, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, Philadelphia, United States.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.02.005']
758,31710801,"Effects of vitamin D supplements in patients with chronic hepatitis C: a randomized, multi-center, open label study.","BACKGROUND/AIMS


We aimed to assess the role of vitamin D supplementation in the response to pegylated interferon-α (PEG-IFN-α) plus ribavirin (RBV) treatment in patients with chronic hepatitis C (CHC).
METHODS


Our study was a multi-center, randomized controlled trial in 11 hospitals. CHC patients were randomly assigned (1:1) to two groups namely, PEGIFN-α plus RBV (control group) or PEG-IFN-α plus RBV + vitamin D (800 IU daily) (vitamin D group). The primary end-point was the rate of sustained virologic response (SVR).
RESULTS


One hundred forty eight CHC patients were randomly assigned to two groups. Seventy-one patients received the PEG-IFN-α plus RBV and 77 patients received the PEG-IFN-α plus RBV + vitamin D. A total of 105 patients completed the study (control group, 47 vs. vitamin D group, 58). Baseline characteristics were mostly similar in both the groups. There was a modest but non-significant increase in SVR in the vitamin D group compared to the control group with the intention to treat analysis (64.0% vs. 49.3 %, p = 0.071) as well as in the per protocol analysis (control group vs. vitamin D group: 74.5% vs. 84.5%, p = 0.202). Fifty-two patients (73.2%) in the control group and 63 patients (81.8%) in the vitamin D group experienced at least one adverse event. The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111).
CONCLUSION


Vitamin D supplement did not increase SVR in treatment naïve patients with CHC irrespective of genotype.",2020,"The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111).
","['patients with chronic hepatitis C (CHC', 'CHC patients', 'One hundred forty eight CHC patients', '11 hospitals', '105 patients completed the study (control group, 47 vs. vitamin D group, 58', 'patients with chronic hepatitis C']","['PEGIFN-α plus RBV (control group) or PEG-IFN-α plus RBV + vitamin D (800 IU daily) (vitamin D group', 'pegylated interferon-α (PEG-IFN-α) plus ribavirin (RBV', 'vitamin D supplementation', 'PEG-IFN-α plus RBV', 'PEG-IFN-α plus RBV + vitamin D', 'Vitamin D supplement', 'vitamin D', 'vitamin D supplements']","['SVR', 'rate of sustained virologic response (SVR', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",148.0,0.118806,"The drop-out rate due to adverse effects was not different between both groups (control group vs. vitamin D group: 19.7% vs. 10.4%, p = 0.111).
","[{'ForeName': 'Jae Yoon', 'Initials': 'JY', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Sol Ji', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Pharmacology, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Sang Gyune', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Se Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.'}, {'ForeName': 'Soung Won', 'Initials': 'SW', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Moon Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Jae-Jun', 'Initials': 'JJ', 'LastName': 'Shim', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyoung Su', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.'}, {'ForeName': 'Ki Tae', 'Initials': 'KT', 'LastName': 'Suk', 'Affiliation': 'Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.'}, {'ForeName': 'Sang Bong', 'Initials': 'SB', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2018.273']
759,31712711,Correlation between blood pressure variability and subclinical target organ damage in patients with essential hypertension.,"High blood pressure (BP) variability is associated with the increased risk of cardiovascular and renal damage together with increased cardiovascular mortality. The aim of our study was to investigate the relationship between BP variability and subclinical target organ damage (TOD) in patients with controlled essential hypertension. One hundred patients with controlled essential hypertension were randomly selected from outpatient clinic of Beni-Suef University hospital. All patients were subjected to full history taking, physical examination, three separate office BP measurements for assessment of long-term BP variability, ambulatory BP monitoring for short-term variability, and finally different investigations for subclinical TOD. We had 73 patients with subclinical TOD. Long-term visit-to-visit variability was evaluated by measuring SD (standard deviation) and CV (coefficient of variance) of systolic and diastolic BP. None of the parameters of long-term BP variability were significantly higher among patients with TOD compared with those without TOD. For short-term variability evaluated by ambulatory BP monitoring, average real variability (ARV) was the only parameter that had a significant consistent association with TOD in contrast to SD and CV. Finally, Daytime systolic ARV, nighttime diastolic ARV, and age were independent predictors of TOD (P values = 0.014, 0.018, 0.047, and 0.02, respectively). We concluded that ARV could be an appropriate index of BP variability and a more useful predictor of TOD in contrast to other parameters of BP variability.",2020,None of the parameters of long-term BP variability were significantly higher among patients with TOD compared with those without TOD.,"['patients with essential hypertension', 'patients with controlled essential hypertension', '73 patients with subclinical TOD', 'One hundred patients with controlled essential hypertension were randomly selected from outpatient clinic of Beni-Suef University hospital']",['ARV'],"['High blood pressure (BP) variability', 'Daytime systolic ARV, nighttime diastolic ARV', 'SD (standard deviation) and CV (coefficient of variance) of systolic and diastolic BP', 'long-term BP variability', 'cardiovascular mortality', 'ambulatory BP monitoring, average real variability (ARV', 'BP variability and subclinical target organ damage (TOD', 'BP variability', 'blood pressure variability and subclinical target organ damage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]",[],"[{'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",100.0,0.043857,None of the parameters of long-term BP variability were significantly higher among patients with TOD compared with those without TOD.,"[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'El Mokadem', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt. mostafa.elmokadem9@gmail.com.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Boshra', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Abd El Hady', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Kasla', 'Affiliation': 'Cardiology Clinic, 57357 Children Cancer Hospital, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Gouda', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}]",Journal of human hypertension,['10.1038/s41371-019-0286-8']
760,31816096,Endoscopic Versus Microscopic Management of Attic Cholesteatoma: A Randomized Controlled Trial.,"OBJECTIVES


To compare endoscopic transcanal approach to attic cholesteatoma with conventional microscopic transcanal technique METHODS: Seventy-eight patients diagnosed with attic cholesteatoma were randomly assigned into two groups-one undergoing endoscopic approach and the other microscopic technique. The two groups were compared in terms of area of exposure, access to hidden areas in terms of Middle Ear Structural Visibility Index (MESVI), intraoperative time, postoperative pain, vertigo, long-term hearing, and surgical outcomes.
RESULTS


The mean area of exposure in endoscopic atticotomy required was less than that in microscopic group and was found to be statistically significant. The median MESVI for endoscopic group better than that for microscopic group (P < .0001). The mean operating time in endoscopic approach was less than that in case of microscopic approach, with P < .05. The median postoperative pain score in the endoscopic group was less than that in microscopic group (P < .05). No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure. When long-term surgical outcomes were assessed at 1 year, in endoscopic group, one patient had disease recurrence, one cartilage displacement, one perforation, and two had retraction pocket formation. In the microscopic group, two patients had recurrence, four cartilage displacement, one perforation, and five retraction pocket formation.
CONCLUSION


Endoscopic management of limited attic cholesteatoma has definite advantages over the conventional microscopic approach.
LEVEL OF EVIDENCE


1 Laryngoscope, 130:2461-2466, 2020.",2020,No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure.,"['Attic Cholesteatoma', ' Seventy-eight patients diagnosed with attic cholesteatoma']","['endoscopic approach and the other microscopic technique', 'endoscopic transcanal approach to attic cholesteatoma with conventional microscopic transcanal technique']","['vertigo', 'disease recurrence, one cartilage displacement, one perforation, and two had retraction pocket formation', 'median MESVI', 'mean area of exposure in endoscopic atticotomy', 'Middle Ear Structural Visibility Index (MESVI), intraoperative time, postoperative pain, vertigo, long-term hearing, and surgical outcomes', 'median postoperative pain score', 'mean operating time in endoscopic approach']","[{'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0241518', 'cui_str': 'Retraction of tympanic membrane (finding)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0198106', 'cui_str': 'Atticotomy of ear (procedure)'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",78.0,0.0610664,No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure.,"[{'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Sandipta', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Ghosh', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Arunabha', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}]",The Laryngoscope,['10.1002/lary.28446']
761,30955977,"Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial.","BACKGROUND


First-line pembrolizumab monotherapy improves overall and progression-free survival in patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater. We investigated overall survival after treatment with pembrolizumab monotherapy in patients with a PD-L1 TPS of 1% or greater.
METHODS


This randomised, open-label, phase 3 study was done in 213 medical centres in 32 countries. Eligible patients were adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lung cancer without a sensitising EGFR mutation or ALK translocation and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater. Randomisation was computer generated, accessed via an interactive voice-response and integrated web-response system, and stratified by region of enrolment (east Asia vs rest of world), ECOG performance status score (0 vs 1), histology (squamous vs non-squamous), and PD-L1 TPS (≥50% vs 1-49%). Enrolled patients were randomly assigned 1:1 in blocks of four per stratum to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles or the investigator's choice of platinum-based chemotherapy for four to six cycles. Primary endpoints were overall survival in patients with a TPS of 50% or greater, 20% or greater, and 1% or greater (one-sided significance thresholds, p=0·0122, p=0·0120, and p=0·0124, respectively) in the intention-to-treat population, assessed sequentially if the previous findings were significant. This study is registered at ClinicalTrials.gov, number NCT02220894.
FINDINGS


From Dec 19, 2014, to March 6, 2017, 1274 patients (902 men, 372 women, median age 63 years [IQR 57-69]) with a PD-L1 TPS of 1% or greater were allocated to pembrolizumab (n=637) or chemotherapy (n=637) and included in the intention-to-treat population. 599 (47%) had a TPS of 50% or greater and 818 patients (64%) had a TPS of 20% or greater. As of Feb 26, 2018, median follow-up was 12·8 months. Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018). The median surival values by TPS population were 20·0 months (95% CI 15·4-24·9) for pembrolizumab versus 12·2 months (10·4-14·2) for chemotherapy, 17·7 months (15·3-22·1) versus 13·0 months (11·6-15·3), and 16·7 months (13·9-19·7) versus 12·1 months (11·3-13·3), respectively. Treatment-related adverse events of grade 3 or worse occurred in 113 (18%) of 636 treated patients in the pembrolizumab group and in 252 (41%) of 615 in the chemotherapy group and led to death in 13 (2%) and 14 (2%) patients, respectively.
INTERPRETATION


The benefit-to-risk profile suggests that pembrolizumab monotherapy can be extended as first-line therapy to patients with locally advanced or metastatic non-small-cell lung cancer without sensitising EGFR or ALK alterations and with low PD-L1 TPS.
FUNDING


Merck Sharp & Dohme.",2019,"Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018).","['213 medical centres in 32 countries', 'patients with locally advanced or metastatic non-small-cell lung cancer without sensitising EGFR or ALK alterations and with low PD-L1 TPS', 'patients with a PD-L1 TPS of 1% or greater', 'previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer', 'Eligible patients were adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lung cancer without a sensitising EGFR mutation or ALK translocation and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater', 'patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater', 'From Dec 19, 2014, to March 6, 2017, 1274 patients (902 men, 372 women, median age 63 years [IQR 57-69]) with a PD-L1 TPS of 1% or greater were allocated to', 'n=637) or chemotherapy (n=637) and included in the intention-to-treat population']","['platinum-based chemotherapy', 'Pembrolizumab versus chemotherapy', 'pembrolizumab monotherapy', 'pembrolizumab']","['median surival values', 'ECOG performance status score', 'death', 'Overall survival', 'overall survival', 'overall and progression-free survival']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.437817,"Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018).","[{'ForeName': 'Tony S K', 'Initials': 'TSK', 'LastName': 'Mok', 'Affiliation': 'Department of Clinical Oncology, State Key Laboratory of South China, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China. Electronic address: tony@clo.cuhk.edu.hk.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guandong, China.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Kudaba', 'Affiliation': 'Department of Internal Diseases, Riga East Clinical University-Latvian Oncology Center, Riga, Latvia.'}, {'ForeName': 'Dariusz M', 'Initials': 'DM', 'LastName': 'Kowalski', 'Affiliation': 'Department of Lung Cancer and Chest Tumours, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Division of Medical Oncology, Yonsei Cancer Center, Seoul, South Korea.'}, {'ForeName': 'Hande Z', 'Initials': 'HZ', 'LastName': 'Turna', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Castro', 'Affiliation': 'Department of Medical Oncology, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vichien', 'Initials': 'V', 'LastName': 'Srimuninnimit', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Konstantin K', 'Initials': 'KK', 'LastName': 'Laktionov', 'Affiliation': 'Department of Thoracic and Abdominal Oncology, N N Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lubiniecki', 'Affiliation': 'Global Clinical Development, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Biostatistics and Research Design Statistics, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kush', 'Affiliation': 'Global Clinical Development, Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Lopes', 'Affiliation': 'Department of Medical Oncology, Sylvester Comprehensive Cancer Center at the University of Miami, Miami, FL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)32409-7']
762,25766941,Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial.,"BACKGROUND


The optimal management of patients found to have multivessel disease while undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction is uncertain.
OBJECTIVES


CvLPRIT (Complete versus Lesion-only Primary PCI trial) is a U.K. open-label randomized study comparing complete revascularization at index admission with treatment of the infarct-related artery (IRA) only.
METHODS


After they provided verbal assent and underwent coronary angiography, 296 patients in 7 U.K. centers were randomized through an interactive voice-response program to either in-hospital complete revascularization (n = 150) or IRA-only revascularization (n = 146). Complete revascularization was performed either at the time of P-PCI or before hospital discharge. Randomization was stratified by infarct location (anterior/nonanterior) and symptom onset (≤ 3 h or >3 h). The primary endpoint was a composite of all-cause death, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months.
RESULTS


Patient groups were well matched for baseline clinical characteristics. The primary endpoint occurred in 10.0% of the complete revascularization group versus 21.2% in the IRA-only revascularization group (hazard ratio: 0.45; 95% confidence interval: 0.24 to 0.84; p = 0.009). A trend toward benefit was seen early after complete revascularization (p = 0.055 at 30 days). Although there was no significant reduction in death or MI, a nonsignificant reduction in all primary endpoint components was seen. There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups.
CONCLUSIONS


In patients presenting for P-PCI with multivessel disease, index admission complete revascularization significantly lowered the rate of the composite primary endpoint at 12 months compared with treating only the IRA. In such patients, inpatient total revascularization may be considered, but larger clinical trials are required to confirm this result and specifically address whether this strategy is associated with improved survival.",2015,"There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups.
","['patients found to have multivessel disease while undergoing primary', 'patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease', '296 patients in 7 U.K. centers']","['complete versus lesion-only revascularization', 'interactive voice-response program to either in-hospital complete revascularization (n = 150) or IRA-only revascularization', 'percutaneous coronary intervention (P-PCI']","['death or MI', 'composite of all-cause death, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months', 'safety endpoints of major bleeding, contrast-induced nephropathy, or stroke', 'ischemic burden on myocardial perfusion scintigraphy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}]",296.0,0.0768361,"There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups.
","[{'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Gershlick', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, United Kingdom. Electronic address: agershlick@aol.com.'}, {'ForeName': 'Jamal Nasir', 'Initials': 'JN', 'LastName': 'Khan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Damian J', 'Initials': 'DJ', 'LastName': 'Kelly', 'Affiliation': 'Department of Cardiology, Royal Derby Hospital, Derby, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and the Division of Cardiovascular and Diabetes Research, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom; Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Thiagarajah', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Clinical Trials and Evaluation Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London, London, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Curzen', 'Affiliation': 'University Hospital Southampton and Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Blackman', 'Affiliation': 'Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': 'Royal Brompton & Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Fairbrother', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'National Institute for Health Research Cardiovascular Biomedical Research Unit, Royal Brompton & Harefield NHS Trust, London, United Kingdom.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust and Norwich Medical School, University of East Anglia Norwich, United Kingdom.'}, {'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Hetherington', 'Affiliation': 'Kettering General Hospital, Kettering, United Kingdom.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Kelion', 'Affiliation': 'Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gunning', 'Affiliation': 'Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, Staffordshire, United Kingdom.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust and Norwich Medical School, University of East Anglia Norwich, United Kingdom.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Swanton', 'Affiliation': 'The Heart Hospital, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, United Kingdom.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2014.12.038']
763,31821664,Randomised controlled trial: Shoulder-umbilicus length versus body weight measurement for optimal endotracheal tube depth estimation in ventilated infants.,"AIM


The optimal placement of the endotracheal tube (ETT) in ventilated infants is essential, but birthweight may be not the best parameter to predict it. The aim of this study was a direct comparison of shoulder-umbilical length (experimental group) versus birthweight (control group) as predictor of optimal ETT placement in Malaysian ventilated infants.
METHODS


All infants requiring ventilation in the neonatal intensive care unit of a tertiary hospital in Malaysia during the 4-month study period were eligible to enter this randomised controlled trial. All participants were randomised into two groups: experimental and control group. The main outcome measure was malposition of the ETT (requiring adjustment), as seen on the chest X-ray performed within 1 h after intubation. Tube placement was assessed by two neonatologists, blinded to the allocation.
RESULTS


One hundred and ten infants were randomised, 55 in each group. The ETT was malpositioned in 13 of 55 infants (23%) for the experimental group and 22 of 55 infants (40%) in the control group (P = 0.06).
CONCLUSION


In the experimental group, fewer infants showed a need for tube adjustment than in the control group. While a larger study may be necessary to show statistical significance, the difference shown in this study may be large enough to be of clinical significance.",2020,"In the experimental group, fewer infants showed a need for tube adjustment than in the control group.","['One hundred and ten infants', 'Malaysian ventilated infants', 'ventilated infants', 'All infants requiring ventilation in the neonatal intensive care unit of a tertiary hospital in Malaysia during the 4-month study period']","['Shoulder-umbilicus length versus body weight measurement', 'endotracheal tube (ETT', 'shoulder-umbilical length (experimental group) versus birthweight (control group']","['malposition of the ETT (requiring adjustment), as seen on the chest X-ray']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0041638', 'cui_str': 'Umbilicus'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0333042', 'cui_str': 'Malposition (morphologic abnormality)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}]",110.0,0.123552,"In the experimental group, fewer infants showed a need for tube adjustment than in the control group.","[{'ForeName': 'Adam Al-Anas Bin', 'Initials': 'AAB', 'LastName': 'Mat Ali', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Ariffin', 'Initials': 'A', 'LastName': 'Nasir', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Ramli', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Nor R', 'Initials': 'NR', 'LastName': 'Ibrahim', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Van Rostenberghe', 'Affiliation': 'Paediatric Department, Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, Kubang Kerian, Malaysia.'}]",Journal of paediatrics and child health,['10.1111/jpc.14705']
764,31462137,The impact of neutrophil-lymphocyte ratio on risk reclassification of patients with advanced renal cell cancer to guide risk-directed therapy.,"Background:  An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC). We examined whether the addition of NLR improves the risk reclassification of advanced RCC using current prognostic tools from the Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Methods:  Using randomised data from the COMPARZ trial of first-line pazopanib vs. sunitinib in advanced RCC, we constructed multivariable models containing MSKCC and IMDC predictor variables with and without NLR. We evaluated model discrimination using the concordance index (C-index). We computed net reclassification improvement to quantify patient reclassification into low/intermediate/poor risk groups with the addition of NLR. Results:  Of 1102 patients, NLR ≥ 5 (16%) was associated with shorter survival adjusting for MSKCC variables (adjusted HR 1.89,  p  < .001). Adding NLR to MSKCC variables increased the C-index by 0.01. Among patients who died before 24 months ( N  = 415), adding NLR reclassified 8% and 2% to a higher and lower risk category, respectively. Among those alive at 24 months ( N  = 636), adding NLR reclassified 4% and 1% to a higher and lower risk category, respectively. This finding translates to a net benefit of eight additional patients who die within 24 months correctly identified as poor risk per 1000 patients tested. We obtained similar results when evaluating NLR with IMDC variables. Conclusions:  NLR does not substantially improve risk reclassification over pre-existing prognostic tools. MSKCC and IMDC classifications remain the standard for guiding risk-directed therapy and trial stratification of patients with advanced RCC.",2020,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"['advanced renal cell carcinoma (RCC', 'patients with advanced RCC', 'patients with advanced renal cell cancer to guide risk-directed therapy']","['pazopanib vs. sunitinib', 'NLR', 'neutrophil-lymphocyte ratio']","['elevated neutrophil-lymphocyte ratio (NLR', 'shorter survival adjusting for MSKCC variables', 'C-index']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",1102.0,0.032522,An elevated neutrophil-lymphocyte ratio (NLR) is associated with poor prognosis in advanced renal cell carcinoma (RCC).,"[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tjokrowidjaja', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Translational Cancer Research Network, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'H Malcolm', 'Initials': 'HM', 'LastName': 'Hudson', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lord', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'de Souza', 'Affiliation': 'Department of Medical Oncology, Liverpool Hospital, Liverpool, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Chee Khoon', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2019.1656342']
765,31709910,Supporting Our Lifelong Engagement: Mothers and Teens Exercising ( SOLE MATES ); a feasibility trial.,"This study aimed to examine the feasibility of the Supporting Our Lifelong Engagement; Mothers and Teens Exercising ( SOLE MATES ) program.  SOLE MATES , a single-arm six-week feasibility trial, comprised six face-to-face sessions. Participants were mothers (n = 27) with daughters (n = 31) aged 12-16 years. Data were collected in Ireland between January 2018 and March 2018. Feasibility benchmarks examined recruitment, data collection, acceptability, resources and participant responses. The primary outcome was daughters' step counts, measured via sealed pedometer for seven consecutive days at baseline and six weeks. Secondary outcomes included mothers' step counts, measures of communication, co-participation in activity, health-related quality of life and parenting practices. Feasibility benchmarks were reached or exceeded, except for retention. Eligibility rates were 93.4%, and baseline activity levels were low. Program content, measures and facilitators were acceptable, demonstrated through a mean score of 4.14 (SD 0.3) on a 5-point Likert Scale. Daily steps increased in mothers (2,875 increase,  p  = .009) and daughters (1,393 increase,  p  = .007). Positive feasibility metrics demonstrated the program's appeal. Participant responses for outcome measures also indicated program success. However, the relatively homogenous sample and relatively poor initial participation rate were study limitations. The intervention should be evaluated in a randomized controlled trial.",2020,"Daily steps increased in mothers (2,875 increase,  p  = .009) and daughters (1,393 increase,  p  = .007).",['Participants were mothers (n\xa0=\xa027) with daughters (n\xa0=\xa031) aged 12-16\xa0years'],[],"['5-point Likert Scale', ""daughters' step counts, measured via sealed pedometer"", ""mothers' step counts, measures of communication, co-participation in activity, health-related quality of life and parenting practices"", 'Feasibility benchmarks examined recruitment, data collection, acceptability, resources and participant responses', 'Feasibility benchmarks', 'baseline activity levels', 'Eligibility rates']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1393.0,0.0401644,"Daily steps increased in mothers (2,875 increase,  p  = .009) and daughters (1,393 increase,  p  = .007).","[{'ForeName': 'Méabh', 'Initials': 'M', 'LastName': 'Corr', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, University of Limerick , Limerick, Ireland.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'McMullen', 'Affiliation': 'School of Sport and Exercise Science, University of Northern Colorado , Greeley, Colorado, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Newcastle, Australia.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Barnes', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Newcastle, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Murtagh', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, University of Limerick , Limerick, Ireland.'}]",Women & health,['10.1080/03630242.2019.1688446']
766,30885389,Making eye movements during imaginal exposure leads to short-lived memory effects compared to imaginal exposure alone.,"BACKGROUND AND OBJECTIVES


A plethora of eye movement desensitization and reprocessing (EMDR) analogue studies has shown that, in the short term, making eye movements (EM) during brief imaginal exposure (""recall + EM"") blurs memories more than just imaginal exposure (""recall only""). Yet, results of the few studies that included a follow-up test are inconsistent. We improved this paradigm's ecological validity by including an extended intervention phase and multiple assessments per phase. We hypothesized that recall + EM results in larger immediate and 24 h reductions in memory vividness, negative valence, and distress than recall alone. We explored the persistence of the effects, as well as the predictive value of memory characteristics and individual differences.
METHODS


Students (N = 100) selected a negative autobiographical memory and were randomized to recall + EM or recall alone; both interventions lasted 32 intervals of 24s. During the interventions they rated the memory after every four intervals.
RESULTS


After 4 × 24s intervention, recall + EM resulted in memory deflation, while recall only caused memory inflation. After the full intervention (i.e., 32 × 24s), both conditions resulted in immediate and 24 h reductions on all outcome measures. Crucially, memory effects in the recall + EM condition partially relapsed 24 h later, while the effects in the recall only condition persisted. Change patterns were hardly explained by predictive variables.
LIMITATIONS


We used a non-clinical sample; replication in clinical samples is warranted.
CONCLUSION


Making EM during imaginal exposure leads to short-lived effects compared to imaginal exposure alone. However, EM may offer a response aid for those who avoid imaginal exposure.",2020,"We hypothesized that recall + EM results in larger immediate and 24 h reductions in memory vividness, negative valence, and distress than recall alone.",['Students (N\xa0=\xa0100) selected a negative autobiographical memory and were randomized to'],['recall\xa0+\xa0EM or recall alone'],"['memory vividness, negative valence, and distress', 'memory deflation, while recall only caused memory inflation']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}]",[],"[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}]",100.0,0.0396095,"We hypothesized that recall + EM results in larger immediate and 24 h reductions in memory vividness, negative valence, and distress than recall alone.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Veen', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands. Electronic address: S.C.vanVeen@uu.nl.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'van Schie', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands; Department of Psychology, Education and Child Studies, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Rens', 'Initials': 'R', 'LastName': 'van de Schoot', 'Affiliation': 'Department of Methods and Statistics, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'van den Hout', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.03.001']
767,30900268,Tolerability and Effects of the Use of Energy-Enriched Infant Formula After Congenital Heart Surgery: A Randomized Controlled Trial.,"BACKGROUND


Undernutrition is a common problem among children with congenital heart disease (CHD) and may lead to poorer surgical outcomes. A higher intake of energy during the postoperative period of CHD surgery seems to be associated with better outcomes. This study aimed to investigate the effect of the use of energy-enriched formula (EE-formula) compared with normocaloric formula during 30 days after CHD surgery.
METHODS


A randomized controlled trial with patients undergoing heart surgery in a tertiary hospital in southern Brazil from March 2017 to December 2017 was performed. The intervention group received EE-formula (1 kcal/mL), and the control group received normocaloric formula (0.67 kcal/mL). The researcher in charge of anthropometric evaluation was blinded to the randomization.
RESULTS


Fifty-nine patients were included; 30 in control group and 29 in intervention group. There were no statistically significant differences between groups regarding age, gender, anthropometry, and surgical risk classification after randomization. A statistically significant difference in z-score of weight for age and in weight gain variation rate between groups after intervention was observed. Antibiotic use was less frequent in the intervention group, and hospital length of stay was shorter. General gastrointestinal side effects were similar between groups, whereas diarrhea was more frequent in the intervention group. However, this side effect was limited and had spontaneous resolution in 4 out of 6 cases.
CONCLUSION


This study demonstrates that EE-formula use after heart surgery of patients with CHD is well tolerated and may improve short-term nutrition outcome, decrease hospital stay, and reduce antibiotic use.",2020,A statistically significant difference in z-score of weight for age and in weight gain variation rate between groups after intervention was observed.,"['children with congenital heart disease (CHD', 'Fifty-nine patients were included; 30 in control group and 29 in intervention group', 'patients undergoing heart surgery in a tertiary hospital in southern Brazil from March 2017 to December 2017 was performed', 'After Congenital Heart Surgery']","['Energy-Enriched Infant Formula', 'EE-formula', 'control group received normocaloric formula', 'energy-enriched formula (EE-formula', 'normocaloric formula']","['General gastrointestinal side effects', 'Antibiotic use', 'hospital stay', 'z-score of weight for age and in weight gain variation rate', 'spontaneous resolution', 'diarrhea', 'hospital length of stay', 'Tolerability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}]","[{'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",59.0,0.257136,A statistically significant difference in z-score of weight for age and in weight gain variation rate between groups after intervention was observed.,"[{'ForeName': 'Vanessa Adriana', 'Initials': 'VA', 'LastName': 'Scheeffer', 'Affiliation': 'Hospital da Criança Santo Antônio, Porto Alegre, Brazil.'}, {'ForeName': 'Claudia Pires', 'Initials': 'CP', 'LastName': 'Ricachinevsky', 'Affiliation': 'Intensive Care Unit at Hospital da Criança Santo Antônio, Porto Alegre, Brazil.'}, {'ForeName': 'Alessandra Thaís', 'Initials': 'AT', 'LastName': 'Freitas', 'Affiliation': 'Fundação Faculdade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Salamon', 'Affiliation': 'Fundação Faculdade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Flavia Feijó Nunes', 'Initials': 'FFN', 'LastName': 'Rodrigues', 'Affiliation': 'Hospital da Criança Santo Antônio, Porto Alegre, Brazil.'}, {'ForeName': 'Tamires Goldani', 'Initials': 'TG', 'LastName': 'Brondani', 'Affiliation': 'Intensive Care Unit at Hospital da Criança Santo Antônio, Porto Alegre, Brazil.'}, {'ForeName': 'Andrea Tomasi', 'Initials': 'AT', 'LastName': 'Sutil', 'Affiliation': 'Hospital da Criança Santo Antônio, Porto Alegre, Brazil.'}, {'ForeName': 'Cristina Helena Targa', 'Initials': 'CHT', 'LastName': 'Ferreira', 'Affiliation': 'Department of Pediatric Gastroenterology, Hospital da Criança Santo Antônio, Porto Alegre, Brazil.'}, {'ForeName': 'Ursula da Silveira', 'Initials': 'UDS', 'LastName': 'Matte', 'Affiliation': 'Postgraduate Programme of Child and Adolescent Health, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Themis Reverbel', 'Initials': 'TR', 'LastName': 'da Silveira', 'Affiliation': 'Hospital da Criança Santo Antônio, Porto Alegre, Brazil.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1530']
768,30882284,Start-up propulsion biomechanics changes with fatiguing activity in persons with spinal cord injury.,"Objective:  Shoulder pathology is a common condition in wheelchair users that can considerably impact quality of life. Shoulder muscles are prone to fatigue, but it is unclear how fatigue affects start-up propulsion biomechanics. This study determines acute changes in start-up wheelchair propulsion biomechanics at the end of a fatiguing propulsion protocol.  Design:  Quasi-experimental one-group pretest-postest design.  Setting:  Biomechanics laboratory . Participants:  Twenty-six wheelchair users with spinal cord injury (age: 35.5 ± 9.8 years, sex: 73% males and 73% with a paraplegia).  Interventions:  Protocol of 15 min including maximum voluntary propulsion, right- and left turns, full stops, start-up propulsion, and rests.  Outcome measures:  Maximum resultant force, maximum rate of rise of applied force, mean velocity, mean fraction of effective force, and mean contact time at the beginning and end of the protocol during start-up propulsion.  Results:  There was a significant reduction in maximum resultant force (P < 0.001) and mean velocity (P < 0.001) at the end of the protocol. Also, contact time was reduced in the first stroke of start-up propulsion (P < 0.001). Finally, propelling with a shorter contact time was associated with a greater reduction in performance (maximum velocity) at the end of the protocol.  Conclusion:  There are clear changes in overground propulsion biomechanics at the end of a fatiguing propulsion protocol. While reduced forces could protect the shoulder, these reduced forces come with shorter contact times and lower velocity. Investigating changes in start-up propulsion biomechanics with fatigue could provide insight into injury risk.",2020,"Also, contact time was reduced in the first stroke of start-up propulsion (P < 0.001).","['persons with spinal cord injury', 'Twenty-six wheelchair users with spinal cord injury (age: 35.5\u2009±\u20099.8 years, sex: 73% males and 73% with a paraplegia']","['Protocol of 15 min including maximum voluntary propulsion, right- and left turns, full stops, start-up propulsion, and rests']","['mean velocity', 'performance (maximum velocity', 'contact time', 'maximum resultant force', 'Maximum resultant force, maximum rate of rise of applied force, mean velocity, mean fraction of effective force, and mean contact time at the beginning and end of the protocol during start-up propulsion']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]",,0.0635597,"Also, contact time was reduced in the first stroke of start-up propulsion (P < 0.001).","[{'ForeName': 'Fransiska M', 'Initials': 'FM', 'LastName': 'Bossuyt', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Hogaboom', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Worobey', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Koontz', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ursina', 'Initials': 'U', 'LastName': 'Arnet', 'Affiliation': 'Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Boninger', 'Affiliation': 'Department of Veterans Affairs, Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2019.1582603']
769,30870136,Fenofibrate therapy to lower serum triglyceride concentrations in persons with spinal cord injury: A preliminary analysis of its safety profile.,"Context:  Fenofibrate is used to treat elevated serum triglyceride (TG) concentrations (e.g. ≥150 mg/dl). The lipoprotein profile of most individuals with spinal cord injury (SCI) would not satisfy conventional criteria to initiate lipid-lowering therapies. Serum TG concentrations of 115 and 137 mg/dl were recently identified as potential intervention thresholds for persons with a SCI proximal to the 4th and below the 5th thoracic vertebrae, respectively. Fenofibrate therapy has not been tested for safety in persons with SCI.  Methods:  An open-label trial was performed in 15 persons with SCI to determine the safety profile of 4 months of once-daily fenofibrate (145 mg tablet) treatment when initiated using modified intervention thresholds. Fasting blood tests and a review of systems were performed monthly to determine changes in liver and kidney function, as well as overall health status.  Results:  Fifteen subjects participated and 4 had an adverse event (e.g. 2 with gastrointestinal distress; 2 with elevated liver enzymes). Three subjects discontinued the trial within the first month and one participant remained in the trial with no further adverse events. Two participants were discontinued from fenofibrate after 2 months after not responding to treatment, as per protocol, and 10 participants completed the 4-month trial without experiencing an adverse event.  Conclusion:  In persons with SCI, 4 months of fenofibrate therapy initiated at lower threshold serum TG concentrations did not result in an increased incidence of adverse events compared to that reported in the general population. Fenofibrate therapy appears to be well tolerated in persons with SCI.",2020,"In persons with SCI, 4 months of fenofibrate therapy initiated at lower threshold serum TG concentrations did not result in an increased incidence of adverse events compared to that reported in the general population.","['15 persons with SCI', 'persons with SCI', 'persons with spinal cord injury', 'individuals with spinal cord injury (SCI', 'Fifteen subjects participated and 4 had an adverse event (e.g. 2 with gastrointestinal distress; 2 with elevated liver enzymes']","['Fenofibrate therapy', 'Fenofibrate', 'fenofibrate']","['serum TG concentrations', 'Fasting blood tests', 'adverse events', 'serum triglyceride concentrations', 'serum triglyceride (TG) concentrations', 'Serum TG concentrations']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}]",15.0,0.0333488,"In persons with SCI, 4 months of fenofibrate therapy initiated at lower threshold serum TG concentrations did not result in an increased incidence of adverse events compared to that reported in the general population.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'La Fountaine', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hobson', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lombard', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Specht', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, New Jersey, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical, Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, New York, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2019.1581694']
770,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
771,30864528,Investigation of the Roles of New Antiepileptic Drugs and Serum BDNF Levels in Efficacy and Safety Monitoring and Quality of Life: A Clinical Research.,"OBJECTIVE


We aimed to determine the therapeutic drug monitoring (TDM) features and the relation to Brain-Derived Neurotrophic Factor (BDNF) of frequently used new antiepileptic drugs (NADs) including lamotrigine (LTG), oxcarbazepine (OXC), zonisamide (ZNS) and lacosamide (LCM). Moreover, we investigated their effect on the quality of life (QoL).
METHODS


Eighty epileptic patients who had been using the NADs, and thirteen healthy participants were included in this cross-sectional study. The participants were randomized into groups. The QOLIE-31 test was used for the assessment of QoL. We also prepared and applied ""Safety Test"". HPLC method for TDM, and ELISA method for BDNF measurements were used consecutively.
RESULTS


In comparison to healthy participants, epileptic participants had lower marriage rate (p=0.049), education level (p˂0.001), alcohol use (p=0.002). BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016). There were negative correlations between serum BDNF levels and serum ZNS levels (p=0.042) with LTGpolytherapy, serum MHD levels (a 10-monohydroxy derivative of OXC, p=0.041) with OXCmonotherapy. There was no difference in BDNF according to monotherapy-polytherapy, drugresistant groups, regarding seizure frequency. There was a positive correlation between total health status and QoL (p˂0.001). QOLIE-31 overall score (OS) was higher in those with OXCmonotherapy (76.5±14.5). OS (p˂0.001), seizure worry (SW, p=0.004), cognition (C, p˂0.001), social function (SF, p˂0.001) were different in the main groups. Forgetfulness was the most common unwanted effect.
CONCLUSION


While TDM helps the clinician to use more effective and safe NADs, BDNF may assist in TDM for reaching the therapeutic target in epilepsy.",2020,BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016).,"['Eighty epileptic patients who had been using the NAD, thirteen healthy participants were included in this cross-sectional study', 'Conclussion']","['OXC-monotherapy', 'lamotrigine (LTG), oxcarbazepine (OXC), zonisamide (ZNS) and lacosamide (LCM']","['marriage rate', 'serum MHD levels (10-monohydroxy derivative of OXC', 'BDNF', 'seizure worry (SW, p=0.004), cognition (C, p˂0.001), social function', 'total health status and QoL', 'QOLIE-31 overall score (OS', 'BDNF levels', 'quality of life (QoL', 'serum BDNF levels and serum ZNS levels', 'education level', 'efficacy and safety monitoring and quality of life']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}]","[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0078844', 'cui_str': 'zonisamide'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}]","[{'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",13.0,0.0902854,BDNF levels were higher in patients with focal epilepsy (p=0.013) and in those with higher education level (p=0.016).,"[{'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Demir', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Emel O', 'Initials': 'EO', 'LastName': 'Akarsu', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Hava O', 'Initials': 'HO', 'LastName': 'Dede', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Bebek', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Sevda O', 'Initials': 'SO', 'LastName': 'Yıldız', 'Affiliation': 'Department of Biostatistics, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Baykan', 'Affiliation': 'Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Fatih / Capa 34093, Istanbul, Turkey.'}, {'ForeName': 'Ahmet G', 'Initials': 'AG', 'LastName': 'Akkan', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Cerrahpasa Faculty of Medicine, Istanbul University, Cerrahpasa Street / Fatih 34093, Istanbul, Turkey.'}]",Current clinical pharmacology,['10.2174/1574884714666190312145409']
772,32407535,Comparative Reactogenicity of Enhanced Influenza Vaccines in Older Adults.,"BACKGROUND


We analyzed data from a randomized controlled trial on the reactogenicity of 3 enhanced influenza vaccines compared with standard-dose (SD) inactivated influenza vaccine.
METHODS


We enrolled community-dwelling older adults in Hong Kong, and we randomly allocated them to receive 2017-2018 northern hemisphere formulations of SD vaccine (FluQuadri; Sanofi Pasteur), MF59-adjuvanted vaccine (FLUAD; Seqirus), high-dose (HD) vaccine (Fluzone High-Dose; Sanofi Pasteur), or recombinant hemagglutinin vaccine (Flublok; Sanofi Pasteur). Local and systemic reactions were evaluated at days 1, 3, 7, and 14 after vaccination.
RESULTS


Reported reactions were generally mild and short-lived. Systemic reactions occurred in similar proportions of participants by vaccine. Some local reactions were slightly more frequently reported among recipients of the MF59-adjuvanted and HD vaccines than among SD vaccine recipients. Participants reporting feverishness 1 day after vaccination had mean fold rises in postvaccination hemagglutination inhibition titers that were 1.85-fold higher (95% confidence interval, 1.01-3.38) for A(H1N1) than in those who did not report feverishness.
CONCLUSIONS


Some acute local reactions were more frequent after vaccination with MF59-adjuvanted and HD influenza vaccines, compared with SD inactivated influenza vaccine, whereas systemic symptoms occurred at similar frequencies in all groups. The association between feverishness and immunogenicity should be further investigated in a larger population.
CLINICAL TRIALS REGISTRATION


NCT03330132.",2020,"Participants reporting feverishness one day after vaccination had mean-fold-rises in post-vaccination hemagglutination inhibition titers that were 1.85-fold higher (95% CI: 1.01, 3.38) for A(H1N1) compared to those who did not report feverishness.
","['enrolled community-dwelling older adults in Hong Kong', 'Older Adults']","['standard-dose inactivated influenza vaccine', 'influenza vaccines', 'Enhanced\xa0Influenza\xa0Vaccines', '2017/18 northern hemisphere formulations of: standard-dose vaccine (FluQuadri, Sanofi Pasteur); MF59-adjuvanted vaccine (FLUAD, Seqirus); high-dose vaccine (Fluzone High Dose, Sanofi Pasteur); or recombinant-hemagglutinin vaccine (Flublok, Sanofi Pasteur']","['local reactions', 'acute local reactions', 'Systemic reactions', 'Local and systemic reactions', 'mean-fold-rises in post-vaccination hemagglutination inhibition titers', 'systemic symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C2740348', 'cui_str': 'Fluzone High-Dose'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C2353376', 'cui_str': 'FluBlok'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.154772,"Participants reporting feverishness one day after vaccination had mean-fold-rises in post-vaccination hemagglutination inhibition titers that were 1.85-fold higher (95% CI: 1.01, 3.38) for A(H1N1) compared to those who did not report feverishness.
","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Tiffany W Y', 'Initials': 'TWY', 'LastName': 'Ng', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Ranawaka A P M', 'Initials': 'RAPM', 'LastName': 'Perera', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Yuyun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Hau Chi', 'Initials': 'HC', 'LastName': 'So', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Dennis K M', 'Initials': 'DKM', 'LastName': 'Ip', 'Affiliation': 'World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa255']
773,30768383,Treatment Gains Are Sustainable in Pediatric Obsessive-Compulsive Disorder: Three-Year Follow-Up From the NordLOTS.,"OBJECTIVE


This study evaluated the long-term outcomes of a stepped care treatment for pediatric obsessive-compulsive disorder (OCD) and investigated whether response to first-step cognitive-behavioral therapy (CBT) is an important indicator of 3-year outcomes.
METHOD


This study is a part of the Nordic Long-term OCD Treatment Study (NordLOTS), in which 269 children and adolescents were treated with CBT. Nonresponders to CBT were randomized to extended treatment with continued CBT or pharmacotherapy with sertraline. Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) scores no higher than 15 and no higher than 10 were defined as treatment response and remission, respectively. Participants were assessed 2 and 3 years after first-step CBT. Linear mixed-effects models were used to analyze the outcomes.
RESULTS


Intent-to-treat analyses showed a significant decrease in CY-BOCS total score from baseline (24.6) to 3-year follow-up (5.0; p = .001), with a mean decrease of 5.9 from after treatment to 3-year follow-up. Three years after treatment, 90% (n = 242) of participants were rated as responders and 73% were in clinical remission. The duration of treatment did not influence the symptom level at 3-year follow-up (p = .998) and no significant difference was found (p = .169) between the extended treatment conditions.
CONCLUSION


The results suggest that evidence-based treatment for pediatric OCD has long-term positive effects, whether a first step of manual-based CBT or extended treatment with CBT or sertraline. The improvements were maintained, and the symptoms decreased further during follow-up and were, after 3 years, similarly independent of treatment duration and form of extended treatment.
CLINICAL TRIAL REGISTRATION INFORMATION


Nordic Long-term Obsessive-Compulsive Disorder (OCD) Treatment Study; www.controlled-trials.com; ISRCTN66385119.",2020,"The duration of treatment did not influence the symptom level at 3-year follow-up (p = .998) and no significant difference was found (p = .169) between the extended treatment conditions.
","['pediatric obsessive-compulsive disorder (OCD', 'Pediatric Obsessive-Compulsive Disorder', '269 children and adolescents']","['step cognitive-behavioral therapy (CBT', 'CBT or sertraline', 'CBT or pharmacotherapy with sertraline', 'CBT', 'stepped care treatment']","['CY-BOCS total score', 'symptom level', ""Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) scores""]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]",269.0,0.0473052,"The duration of treatment did not influence the symptom level at 3-year follow-up (p = .998) and no significant difference was found (p = .169) between the extended treatment conditions.
","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Melin', 'Affiliation': 'Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: karin.a.melin@vgregion.se.'}, {'ForeName': 'Gudmundur', 'Initials': 'G', 'LastName': 'Skarphedinsson', 'Affiliation': 'Faculty of Psychology, University of Iceland, Reykjavik.'}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Weidle', 'Affiliation': ""Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway; St. Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Nor Christian', 'Initials': 'NC', 'LastName': 'Torp', 'Affiliation': 'Division of Mental Health and Addiction, Vestre Viken Hospital, Drammen, Norway.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Valderhaug', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway; Hospital of Aalesund, Aalesund, Norway.'}, {'ForeName': 'Davíð R M A', 'Initials': 'DRMA', 'LastName': 'Højgaard', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Katja A', 'Initials': 'KA', 'LastName': 'Hybel', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Judith Becker', 'Initials': 'JB', 'LastName': 'Nissen', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Jensen', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Dahl', 'Affiliation': 'Centre for Child and Adolescent Mental Health, Eastern and Southern Norway, Oslo, Norway.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Skärsäter', 'Affiliation': 'School of Health and Social Sciences, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Bente Storm', 'Initials': 'BS', 'LastName': 'Haugland', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Uni Research Health, Bergen, Norway.'}, {'ForeName': 'Tord', 'Initials': 'T', 'LastName': 'Ivarsson', 'Affiliation': 'Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.01.010']
774,30783173,Hypoallergenic and anti-inflammatory feeds in children with complicated severe acute malnutrition: an open randomised controlled 3-arm intervention trial in Malawi.,"Intestinal pathology in children with complicated severe acute malnutrition (SAM) persists despite standard management. Given the similarity with intestinal pathology in non-IgE mediated gastrointestinal food allergy and Crohn's disease, we tested whether therapeutic feeds effective in treating these conditions may benefit children with complicated SAM. After initial clinical stabilisation, 95 children aged 6-23 months admitted at Queen Elizabeth Central Hospital, Blantyre, Malawi between January 1 st  and December 31 st , 2016 were allocated randomly to either standard feeds, an elemental feed or a polymeric feed for 14 days. Change in faecal calprotectin as a marker of intestinal inflammation and the primary outcome was similar in each arm: elemental vs. standard 4.1 μg/mg stool/day (95% CI, -29.9, 38.15; P = 0.81) and polymeric vs. standard 10 (-23.96, 43.91; P = 0.56). Biomarkers of intestinal and systemic inflammation and mucosal integrity were highly abnormal in most children at baseline and abnormal values persisted in all three arms. The enteropathy in complicated SAM did not respond to either standard feeds or alternative therapeutic feeds administered for up to 14 days. A better understanding of the pathogenesis of the gut pathology in complicated SAM is an urgent priority to inform the development of improved therapeutic interventions.",2019,Biomarkers of intestinal and systemic inflammation and mucosal integrity were highly abnormal in most children at baseline and abnormal values persisted in all three arms.,"['children with complicated SAM', 'children with complicated severe acute malnutrition (SAM', '95 children aged 6-23 months admitted at Queen Elizabeth Central Hospital, Blantyre, Malawi between January 1 st  and December 31 st , 2016', 'children with complicated severe acute malnutrition']",['Hypoallergenic and anti-inflammatory feeds'],"['faecal calprotectin', 'Intestinal pathology', 'Biomarkers of intestinal and systemic inflammation and mucosal integrity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",95.0,0.0949247,Biomarkers of intestinal and systemic inflammation and mucosal integrity were highly abnormal in most children at baseline and abnormal values persisted in all three arms.,"[{'ForeName': 'Rosalie H', 'Initials': 'RH', 'LastName': 'Bartels', 'Affiliation': ""Global Child Health Group, Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. rhbartels@hotmail.com.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chimwezi', 'Affiliation': 'Department of Paediatrics and Child Health, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Watson', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Potani', 'Affiliation': 'Department of Paediatrics and Child Health, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Allubha', 'Affiliation': 'Department of Paediatrics and Child Health, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Chidzalo', 'Affiliation': 'Department of Paediatrics and Child Health, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Queen', 'Initials': 'Q', 'LastName': 'Dube', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Macpherson', 'Initials': 'M', 'LastName': 'Mallewa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Centre for Tropical Infectious Diseases, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Robert H J', 'Initials': 'RHJ', 'LastName': 'Bandsma', 'Affiliation': 'The Childhood Acute Illness & Nutrition Network, Nairobi, Kenya.'}, {'ForeName': 'Wieger P', 'Initials': 'WP', 'LastName': 'Voskuijl', 'Affiliation': ""Global Child Health Group, Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Allen', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",Scientific reports,['10.1038/s41598-019-38690-9']
775,30352583,Effect of 24-month physical activity on cognitive frailty and the role of inflammation: the LIFE randomized clinical trial.,"BACKGROUND


Whether physical activity can reduce cognitive frailty-a relatively new ""compound"" phenotype proposed in 2013-and whether the effect of physical activity differs based on levels of inflammation are unknown. Therefore, this study aimed to evaluate the effect of physical activity on cognitive frailty and whether baseline interleukin-6 (IL-6) levels modified this effect.
METHODS


We used data from the Lifestyle Interventions and Independence for Elders (LIFE) Study, a multicenter, single-blinded randomized trial conducted at eight US field centers between February 2010 and December 2013. The main outcome was cognitive frailty at 24 months, expressed as an ordinal variable based on the six combinations of its two components: frailty (non-frail, pre-frail, and frail) and mild cognitive impairment (yes, no). Frailty and cognition were assessed by the Study of Osteoporotic Fractures (SOF) index and the Modified Mini-Mental State Examination (3MSE) scale, respectively. Plasma IL-6 was measured at baseline. Of the 1635 original randomized sedentary participants (70-89 years), this study included 1298 participants with data on both cognitive frailty and IL-6 assessments at baseline.
RESULTS


After adjusting for field center, sex, and baseline levels of cognitive frailty, the ordinal logistic regression model revealed that participants in the physical activity group had 21% lower odds (odds ratio, 0.79; 95% confidence interval, 0.64-0.98) of worsening cognitive frailty over 24 months than those in the health education group. The effect of physical activity on cognitive frailty did not differ according to baseline IL-6 levels (P for interaction = 0.919). The results did not change after additional adjustment for IL-6 subgroups and the inverse probability of remaining in the study. Comparable results were observed according to age, sex, ethnicity/race, and short physical performance battery score (P for interaction = 0.835, 0.536, 0.934, and 0.458, respectively).
CONCLUSIONS


A 24-month structured, moderate-intensity physical activity program reduced cognitive frailty compared with a health education program in sedentary older persons, and this beneficial effect did not differ according to baseline levels of inflammatory biomarker IL-6. These findings suggest that the new cognitive frailty construct is modifiable and highlight the potential of targeting cognitive frailty for promoting healthy aging.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT01072500.",2018,The effect of physical activity on cognitive frailty did not differ according to baseline IL-6 levels (P for interaction = 0.919).,"['sedentary older persons', 'eight US field centers between February 2010 and December 2013', '1635 original randomized sedentary participants (70-89\xa0years), this study included 1298 participants with data on both cognitive frailty and IL-6 assessments at baseline']",[],"['Plasma IL-6', 'cognitive frailty at 24\xa0months, expressed as an ordinal variable based on the six combinations of its two components: frailty (non-frail, pre-frail, and frail) and mild cognitive impairment (yes, no', 'cognitive frailty', 'baseline IL-6 levels', 'physical performance battery score', 'Frailty and cognition', 'worsening cognitive frailty', 'Osteoporotic Fractures (SOF) index and the Modified Mini-Mental State Examination (3MSE) scale']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607857'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451308', 'cui_str': 'Modified mini-mental state examination (assessment scale)'}, {'cui': 'C0222045'}]",1298.0,0.205081,The effect of physical activity on cognitive frailty did not differ according to baseline IL-6 levels (P for interaction = 0.919).,"[{'ForeName': 'Zuyun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA. zuyun.liu@yale.edu.'}, {'ForeName': 'Fang-Chi', 'Initials': 'FC', 'LastName': 'Hsu', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest University Health Sciences, Winston Salem, NC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Trombetti', 'Affiliation': 'Division of Bone Diseases, Department of Internal Medicine Specialties, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Health Research and Policy and the Stanford Prevention Research Center, Department of Medicine, Stanford University, School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Liu', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kritchevsky', 'Affiliation': 'Sticht Center on Aging, Wake Forest School of Medicine, Winston Salem, NC, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA. thomas.gill@yale.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medicine,['10.1186/s12916-018-1174-8']
776,31710306,An Interactive Parent-Targeted Text Messaging Intervention to Improve Oral Health in Children Attending Urban Pediatric Clinics: Feasibility Randomized Controlled Trial.,"BACKGROUND


Effective preventive treatments for dental decay exist, but caries experience among preschoolers has not changed, with marked disparities in untreated decay. Despite near-universal use of SMS text messaging, there are no studies using text messages to improve the oral health of vulnerable children.
OBJECTIVE


This randomized controlled feasibility trial aimed to test the effects of oral health text messages (OHT) versus a control (child wellness text messages or CWT). OHT was hypothesized to outperform CWT on improving pediatric oral health behaviors and parent attitudes.
METHODS


Parents with a child aged <7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages on reading, safety, physical activity and development, secondhand smoke, and stress) groups. Automated text messages based on Social Cognitive Theory were sent twice each day for 8-weeks. Groups were equivalent on the basis of the number of text messages sent, personalization, interactivity, and opportunity to earn electronic badges and unlock animated characters. Assessments were conducted at baseline and 8 weeks later. Data were analyzed with linear mixed-effects models.
RESULTS


A total of 55 participants were randomized (28 OHT and 27 CWT). Only one participant dropped out during the text message program and 47 (24 OHT and 23 CWT) completed follow up surveys. Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range). Of the OHT group participants, 84% (21/25) would recommend the program to others. Overall program likeability scores were high (OHT mean 5.90; CWT mean 6.0; 1-7 scale range). Participants reported high perceived impact of the OHT program on brushing their child's teeth, motivation to address their child's oral health, and knowledge of their child's oral health needs (mean 4.7, 4.6, and 4.6, respectively; 1-5 scale range). At follow up, compared with CWT, OHT group participants were more likely to brush their children's teeth twice per day (odds ratio [OR] 1.37, 95% CI 0.28-6.50) and demonstrated improved attitudes regarding the use of fluoride (OR 3.82, 95% CI 0.9-16.8) and toward getting regular dental checkups for their child (OR 4.68, 95% CI 0.24-91.4). There were modest, but not significant, changes in motivation (F1,53=0.60; P=.45) and self-efficacy (F1,53=0.24; P=.63) to engage in oral health behaviors, favoring OHT (d=0.28 and d=0.16 for motivation and self-efficacy, respectively).
CONCLUSIONS


The OHT program demonstrated feasibility was well utilized and appealing to the target population and showed promise for efficacy.",2019,Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range).,"['Attending Urban Pediatric Clinics', 'Parents with a child aged <7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to', '55 participants', 'Children']","['CWT', 'OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages', 'oral health text messages (OHT', 'CWT, OHT', 'OHT program', 'Interactive Parent-Targeted Text Messaging Intervention']","[""child's oral health, and knowledge of their child's oral health needs"", 'changes in motivation', 'Response rates', 'Overall program likeability scores', 'overall program satisfaction', 'attitudes regarding the use of fluoride', 'pediatric oral health behaviors', 'self-efficacy', 'oral health behaviors']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic (environment)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0860094', 'cui_str': 'Below poverty line'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0029162'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029162'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",55.0,0.0707227,Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range).,"[{'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Center for Behavioral Science Research, Boston University Henry M Goldman School of Dental Medicine, Boston, MA, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Henshaw', 'Affiliation': 'Center for Research to Evaluate & Eliminate Dental Disparities, Department of Health Policy & Health Services Research, Boston University Henry M Goldman School of Dental Medicine, Boston, MA, United States.'}, {'ForeName': 'Romano', 'Initials': 'R', 'LastName': 'Endrighi', 'Affiliation': 'Center for Behavioral Science Research, Boston University Henry M Goldman School of Dental Medicine, Boston, MA, United States.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Adams', 'Affiliation': 'Department of Pediatrics, Boston Medical Center & Boston University School of Medicine, Boston, MA, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Heeren', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States.'}, {'ForeName': 'Rochelle K', 'Initials': 'RK', 'LastName': 'Rosen', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bock', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Werntz', 'Affiliation': 'Agile Health, Inc, Lincolnshire, IL, United States.'}]",JMIR mHealth and uHealth,['10.2196/14247']
777,27842548,Infarct size following complete revascularization in patients presenting with STEMI: a comparison of immediate and staged in-hospital non-infarct related artery PCI subgroups in the CvLPRIT study.,"BACKGROUND


The CvLPRIT study showed a trend for improved clinical outcomes in the complete revascularisation (CR) group in those treated with an immediate, as opposed to staged in-hospital approach in patients with multivessel coronary disease undergoing primary percutaneous intervention (PPCI). We aimed to assess infarct size and left ventricular function in patients undergoing immediate compared with staged CR for multivessel disease at PPCI.
METHODS


The Cardiovascular Magnetic Resonance (CMR) substudy of CvLPRIT was a multicentre, prospective, randomized, open label, blinded endpoint trial in PPCI patients with multivessel disease. These data refer to a post-hoc analysis in 93 patients randomized to the CR arm (63 immediate, 30 staged) who completed a pre-discharge CMR scan (median 2 and 4 days respectively) after PPCI. The decision to stage non-IRA revascularization was at the discretion of the treating interventional cardiologist.
RESULTS


Patients treated with a staged approach had more visible thrombus (26/30 vs. 31/62, p = 0.001), higher SYNTAX score in the IRA (9.5, 8-16 vs. 8.0, 5.5-11, p = 0.04) and a greater incidence of no-reflow (23.3 % vs. 1.6 % p < 0.001) than those treated with immediate CR. After adjustment for confounders, staged patients had larger infarct size (19.7 % [11.7-37.6] vs. 11.6 % [6.8-18.2] of LV Mass, p = 0.012) and lower ejection fraction (42.2 ± 10 % vs. 47.4 ± 9 %, p = 0.019) compared with immediate CR.
CONCLUSIONS


Of patients randomized to CR in the CMR substudy of CvLPRIT, those in whom the operator chose to stage revascularization had larger infarct size and lower ejection fraction, which persisted after adjusting for important covariates than those who underwent immediate CR. Prospective randomized trials are needed to assess whether immediate CR results in better clinical outcomes than staged CR.
TRIAL REGISTRATION


ISRCTN70913605 , Registered 24th February 2011.",2016,"After adjustment for confounders, staged patients had larger infarct size (19.7 % [11.7-37.6] vs. 11.6 % [6.8-18.2] of LV Mass, p = 0.012) and lower ejection fraction (42.2 ± 10 % vs. 47.4 ± 9 %, p = 0.019) compared with immediate CR.
","['patients presenting with STEMI', 'patients undergoing immediate compared with staged CR for multivessel disease at PPCI', 'patients with multivessel coronary disease undergoing primary percutaneous intervention (PPCI', 'PPCI patients with multivessel disease']",[],"['lower ejection fraction', 'larger infarct size and lower ejection fraction', 'Infarct size', 'visible thrombus', 'higher SYNTAX score', 'incidence of no-reflow', 'infarct size and left ventricular function', 'larger infarct size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0080310', 'cui_str': 'Left Ventricular Function'}]",93.0,0.269107,"After adjustment for confounders, staged patients had larger infarct size (19.7 % [11.7-37.6] vs. 11.6 % [6.8-18.2] of LV Mass, p = 0.012) and lower ejection fraction (42.2 ± 10 % vs. 47.4 ± 9 %, p = 0.019) compared with immediate CR.
","[{'ForeName': 'Jamal N', 'Initials': 'JN', 'LastName': 'Khan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Sheraz A', 'Initials': 'SA', 'LastName': 'Nazir', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and The Division of Cardiovascular and Diabetes Research, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': 'Harefield Hospital, Royal Brompton and Harefield Foundation Trust, NIHR Cardiovascular Biomedical Research Unit, Middlesex, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Curzen', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hetherington', 'Affiliation': 'Kettering General Hospital, Kettering, NN16 8UZ, UK.'}, {'ForeName': 'Damian J', 'Initials': 'DJ', 'LastName': 'Kelly', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Blackman', 'Affiliation': 'Multidisciplinary Cardiovascular Research Centre and The Division of Cardiovascular and Diabetes Research, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Ring', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, UK and Department of Mathematical Statistics and Actuarial Science, University of Leicester, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peebles', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Harefield Hospital, Royal Brompton and Harefield Foundation Trust, NIHR Cardiovascular Biomedical Research Unit, Middlesex, UK.'}, {'ForeName': 'Thiagarajah', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Harefield Hospital, Royal Brompton and Harefield Foundation Trust, NIHR Cardiovascular Biomedical Research Unit, Middlesex, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust and Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Swanton', 'Affiliation': 'The Heart Hospital, University College London Hospitals, London, UK.'}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Gershlick', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK. gpm12@le.ac.uk.'}]",Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance,[]
778,30783732,Inhaled steroids associated with decreased macrophage markers in nonasthmatic individuals with sickle cell disease in a randomized trial.,"Inhaled mometasone was shown to improve pain scores and decrease soluble vascular cell adhesion molecule (sVCAM) concentration in a randomized controlled trial of nonasthmatic patients with sickle cell disease. We sought to explore potential changes in systemic inflammation as a mechanism underlying this effect. Serum samples from 41 trial participants (15 placebo- and 26 mometasone-treated) were analyzed using a 92 inflammatory marker panel at baseline and after 8 weeks of mometasone therapy. Individual marker analysis and correlation analysis were conducted. Adjusted for age, the mometasone-treated group decreased the concentration of CXCL9, CXCL11, CD40, IL-10, and IL-18 relative to placebo-treated participants. Hierarchical clustering and correlation analysis identified additional evidence for a decrease in cytokines linking to macrophage signaling and migration. There was no statistically significant change in markers of asthma and allergy, indicating that the improvement was unlikely mediated by modulation of occult reactive airway disease. This analysis of inflammatory markers suggests that decrease in macrophage activity may be involved in the mediation of the clinical benefit seen with use of inhaled mometasone in nonasthmatic patients with sickle cell disease.Trial registration: clinicaltrials.gov identifier: NCT02061202.",2019,Inhaled mometasone was shown to improve pain scores and decrease soluble vascular cell adhesion molecule (sVCAM) concentration in a randomized controlled trial of nonasthmatic patients with sickle cell disease.,"['nonasthmatic patients with sickle cell disease', 'nonasthmatic individuals with sickle cell disease']","['mometasone therapy', 'mometasone', 'Inhaled mometasone', 'Inhaled steroids']","['macrophage markers', 'concentration of CXCL9, CXCL11, CD40, IL-10, and IL-18 relative', 'pain scores', 'markers of asthma and allergy', 'soluble vascular cell adhesion molecule (sVCAM) concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}]",,0.447673,Inhaled mometasone was shown to improve pain scores and decrease soluble vascular cell adhesion molecule (sVCAM) concentration in a randomized controlled trial of nonasthmatic patients with sickle cell disease.,"[{'ForeName': 'Arielle L', 'Initials': 'AL', 'LastName': 'Langer', 'Affiliation': 'Division of Hematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leader', 'Affiliation': 'Department of Oncological Science, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Seunghee', 'Initials': 'S', 'LastName': 'Kim-Schulze', 'Affiliation': 'Department of Oncological Science, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Ginzburg', 'Affiliation': 'Division of Hematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Merad', 'Affiliation': 'Department of Oncological Science, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Glassberg', 'Affiliation': 'Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1620, New York, NY, 10029-6574, USA. Jeffrey.glassberg@mountsinai.org.'}]",Annals of hematology,['10.1007/s00277-019-03635-9']
779,30878234,Do outcomes following intervention for drug-eluting stent restenosis depend on whether the restenosed stent was polymer-free or polymer-coated?,"INTRODUCTION AND OBJECTIVES


Outcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES.
METHODS


Patients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups.
RESULTS


A total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; P adjusted =.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; P adjusted =.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; P adjusted =.62).
CONCLUSIONS


In patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.",2020,"At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; P adjusted =.79).","['patients undergoing reintervention for DES-ISR', 'Patients enrolled in the ISAR-TEST 5 randomized trial who underwent', '326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES', 'patients undergoing']","['percutaneous intervention for drug-eluting stent (DES) restenosis', 'repeat percutaneous intervention for ISR']","['recurrent binary restenosis', 'rate of repeat target lesion revascularization', 'Angiographic outcomes', 'composite of death, myocardial infarction, or repeat target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",326.0,0.126409,"At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; P adjusted =.79).","[{'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Harada', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': 'Colleran', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Rai', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Bohner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Kuna', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Giacoppo', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, München, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, München, Germany.'}, {'ForeName': 'Tareq', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, München, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, München, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, München, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, München, Germany.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, München, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, München, Germany. Electronic address: byrne@dhm.mhn.de.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2019.01.005']
780,30861163,"Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


The toxic effect of chemotherapy on the gastrointestinal tract may lead to mucositis and is associated with the pathogenesis of other treatment-related complications. We hypothesized that nutrition supplementation with bovine colostrum, rich in bioactive factors, would ameliorate gastrointestinal toxicity and reduce the incidence of fever and infectious complications during induction treatment for childhood acute lymphoblastic leukemia (ALL).
METHODS


Children with newly diagnosed ALL were included in a 2-center, randomized, double-blind, placebo-controlled clinical trial. Patients were randomized to receive a daily colostrum or placebo supplement during 4 weeks of induction treatment. Data on fever, bacteremia, need for antibiotics, and mucosal toxicity were prospectively collected. (Trial registration: www.clinicaltrials.gov NCT01766804).
RESULTS


Sixty-two patients were included. No differences were found for the primary outcome (number of days with fever). No difference was observed for neutropenic fever, intravenous antibiotics, or incidence of bacteremia. Peak severity of oral mucositis was significantly reduced by colostrum (7/29 patients, 24% mild; 6/29, 21% moderate; 1/29, 3% severe) compared with placebo (12/31, 39% mild; 1/31, 3% moderate; 7/31, 23% severe) (P = 0.02). Among patients receiving at least 1 dose of supplement (colostrum: n = 22; placebo: n = 30), the peak weekly self-reported oral mucositis score was overall significantly less severe in the colostrum group (P = 0.009).
CONCLUSION


The use of prophylactic bovine colostrum showed no effect on fever, infectious morbidity, or inflammatory responses. Nevertheless, these data may suggest protective effects on the oral mucosa during induction therapy in childhood ALL, encouraging additional studies confirming these findings.",2020,"Peak severity of oral mucositis was significantly reduced by colostrum (7/29 patients, 24% mild; 6/29, 21% moderate; 1/29, 3% severe) compared with placebo (12/31, 39% mild; 1/31, 3% moderate; 7/31, 23% severe) (P = 0.02).","['Children with newly diagnosed ALL', 'Children With Acute Lymphoblastic Leukemia', 'Sixty-two patients were included', 'childhood acute lymphoblastic leukemia (ALL']","['placebo', 'chemotherapy', 'Placebo', 'Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity', 'prophylactic bovine colostrum', 'daily colostrum or placebo supplement']","['neutropenic fever, intravenous antibiotics, or incidence of bacteremia', 'gastrointestinal toxicity', 'primary outcome (number of days with fever', 'fever, infectious morbidity, or inflammatory responses', 'incidence of fever and infectious complications', 'fever, bacteremia, need for antibiotics, and mucosal toxicity', 'peak weekly self-reported oral mucositis score', 'Peak severity of oral mucositis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3854395', 'cui_str': 'Mucosal toxicity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",62.0,0.783293,"Peak severity of oral mucositis was significantly reduced by colostrum (7/29 patients, 24% mild; 6/29, 21% moderate; 1/29, 3% severe) compared with placebo (12/31, 39% mild; 1/31, 3% moderate; 7/31, 23% severe) (P = 0.02).","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Rathe', 'Affiliation': ""Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'De Pietri', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peder Skov', 'Initials': 'PS', 'LastName': 'Wehner', 'Affiliation': ""Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.""}, {'ForeName': 'Thomas Leth', 'Initials': 'TL', 'LastName': 'Frandsen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Grell', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per Torp', 'Initials': 'PT', 'LastName': 'Sangild', 'Affiliation': ""Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.""}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Husby', 'Affiliation': ""Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.""}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Müller', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1528']
781,30829979,Diagnostic readiness tests: Preparing nurse practitioner students for national certification examinations.,"BACKGROUND AND PURPOSE


Nurse practitioner (NP) faculties are challenged to offer programs that balance didactic knowledge with the clinical experiences required to prepare graduates for the complexities of health care. Students have the stress of extrapolating the information they obtain during these programs and applying it to postgraduation certification examinations. Innovative educational tools are necessary to ease the uncertainty that NP students experience to graduate and pass certification examinations. Tools include academic-clinical partnerships (ACPs) to enhance clinical opportunities and resources to integrate diagnostic readiness tests (DRTs) into curricula.
METHODS


This was a quasi-experimental one group, pretest/posttest design using a convenience sample of NP students randomly assigned to clinical in ACP or non-ACP clinical placements. They completed the DRTs twice during their final program semesters.
CONCLUSIONS


The overall DRT group scores for the NP students significantly improved over time. The Wilcoxon signed ranks test showed that the posttest scores were significantly higher than the pretest scores. The Mann-Whitney U test revealed no differences between the ACP and non-ACP students. Students performed the best on assessment, diagnosis, management, and pharmacology domains. This demonstrates support for the integration of DRTs into NP programs.
IMPLICATIONS FOR PRACTICE


Integrating DRTs into NP programs can facilitate transition to the NP role.",2020,The overall DRT group scores for the NP students significantly improved over time.,['nurse practitioner students for national certification examinations'],['ACP or non-ACP clinical placements'],[],"[{'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",[],,0.013535,The overall DRT group scores for the NP students significantly improved over time.,"[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Coppa', 'Affiliation': 'College of Nursing, University of Rhode Island, South Kingstown, Rhode Island.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Barcelos Winchester', 'Affiliation': 'College of Nursing, University of Rhode Island, South Kingstown, Rhode Island.'}]",Journal of the American Association of Nurse Practitioners,['10.1097/JXX.0000000000000191']
782,31654643,Difference in the Effects of Lidocaine With Epinephrine and Prilocaine With Felypressin on the Autonomic Nervous System During Extraction of the Impacted Mandibular Third Molar: A Randomized Controlled Trial.,"PURPOSE


Complications during local anesthesia include increased blood pressure and vasovagal reflex, which are caused by changes in the autonomic nervous system. The commonly used local anesthetic preparations are lidocaine to which the vasoconstrictor epinephrine is added (lidocaine-epinephrine) and prilocaine to which the vasoconstrictor felypressin is added (prilocaine-felypressin); however, their effects during dental treatment are unclear. We examined the effects of these 2 different local anesthetic preparations on the autonomic nervous system and circulation during extraction of the impacted mandibular third molar.
MATERIALS AND METHODS


In this randomized controlled trial, 40 female patients scheduled for extraction of an impacted mandibular third molar were randomized to the lidocaine-epinephrine group or prilocaine-felypressin group. Heart rate variability, heart rate, and systolic blood pressure were recorded during the experiment. Descriptive and bivariate statistics were computed, and the P value was set at .05.
RESULTS


The low frequency-high frequency ratio was significantly increased in the prilocaine-felypressin group during extraction compared with that in the lidocaine-epinephrine group (P < .05). In the lidocaine-epinephrine group, a significant decrease in the high-frequency component was observed during bone removal and extraction compared with that at rest (P < .05). In both groups, a significant increase in systolic blood pressure was observed during local anesthesia, incision and reflection of the flap, bone removal, separation of the tooth crown, extraction, and suturing compared with that at rest (P < .01).
CONCLUSIONS


This study is the first to investigate the differences in the influence of 2 different local anesthetic preparations on the autonomic nervous system during extraction of the mandibular third molar. Changes in circulatory dynamics during tooth extraction with the 2 different local anesthetic preparations were the result of a decrease in parasympathetic nervous activity with lidocaine-epinephrine and an increase in sympathetic nervous activity with prilocaine-felypressin.",2020,"In both groups, a significant increase in systolic blood pressure was observed during local anesthesia, incision and reflection of the flap, bone removal, separation of the tooth crown, extraction, and suturing compared with that at rest (P < .01).
",['40 female patients scheduled for extraction of an impacted mandibular third molar'],"['Epinephrine', 'lidocaine-epinephrine', 'lidocaine', 'prilocaine', 'Prilocaine', 'prilocaine-felypressin', 'Felypressin', 'Lidocaine']","['sympathetic nervous activity', 'blood pressure and vasovagal reflex', 'local anesthesia, incision and reflection of the flap, bone removal, separation of the tooth crown, extraction, and suturing', 'Heart rate variability, heart rate, and systolic blood pressure', 'high-frequency component', 'parasympathetic nervous activity', 'Autonomic Nervous System', 'systolic blood pressure', 'low frequency-high frequency ratio']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0015777', 'cui_str': 'Felypressin'}]","[{'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0226993', 'cui_str': 'Tooth Crowns'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",40.0,0.0681789,"In both groups, a significant increase in systolic blood pressure was observed during local anesthesia, incision and reflection of the flap, bone removal, separation of the tooth crown, extraction, and suturing compared with that at rest (P < .01).
","[{'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Assistant Professor, Department of Dental Anesthesiology, Field of Oral Maxillofacial Rehabilitation, Developmental Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Kibe', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Field of Oral and Maxillofacial Surgery, Developmental Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan. Electronic address: s2000@dent.kagoshima-u.ac.jp.'}, {'ForeName': 'Rumi', 'Initials': 'R', 'LastName': 'Shidou', 'Affiliation': 'PhD Student, Department of Dental Anesthesiology, Field of Oral Maxillofacial Rehabilitation, Developmental Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kohjitani', 'Affiliation': 'Associate Professor, Department of Dental Anesthesiology, Field of Oral Maxillofacial Rehabilitation, Developmental Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Norifumi', 'Initials': 'N', 'LastName': 'Nakamura', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Field of Oral and Maxillofacial Surgery, Developmental Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Sugimura', 'Affiliation': 'Professor, Department of Dental Anesthesiology, Field of Oral Maxillofacial Rehabilitation, Developmental Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.019']
783,31023553,Effects of (in)validation and plain versus technical language on the experience of experimentally induced pain: A computer controlled simulation paradigm.,"BACKGROUND AND OBJECTIVES


Amongst social contextual influences on pain, the manner in which pain and painful procedures are communicated to patients is considered an important contributor to the subjective experience of pain. Threatening information, e.g., by the use of technical language, is suggested to increase pain reports. Validation, or communicating understanding towards another person reporting personal experiences, is suggested to reduce pain. The current study examines effects of both information language (technical vs. plain language) and validation (validation vs. invalidation) on the subjective experience of experimentally induced pain.
METHODS


Pain-free participants (N = 132) were randomly assigned to one of four groups as formed by manipulations of validation and information language. After reading a description concerning the upcoming thermal stimulus formulated in technical or plain language, participants engaged in a computer controlled simulation (CCS; based on virtual reality technology). Participants received three thermal stimuli while interacting with an avatar who either validated or invalidated their experience during the CCS. Pain intensity and pain unpleasantness were assessed after each stimulus.
RESULTS


The validation manipulation showed to be effective, but the information language manipulation did not induce differential threat expectancies. Results show no effect of validation or information language on subjective pain reports.
LIMITATIONS


Suboptimality of the information language manipulation and shortcomings of the CCS procedure might account for current findings.
CONCLUSIONS


The study offers an interesting model for the further experimental study of isolated and combined effects of (social) contextual factors on pain. Diverse future research avenues are discussed.",2020,"Results show no effect of validation or information language on subjective pain reports.
",['Pain-free participants (N\u202f=\u202f132'],"['social) contextual factors', 'information language (technical vs. plain language) and validation (validation vs. invalidation', 'thermal stimuli while interacting with an avatar who either validated or invalidated their experience during the CCS', 'in)validation and plain versus technical language']","['pain', 'Pain intensity and pain unpleasantness']","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",132.0,0.025102,"Results show no effect of validation or information language on subjective pain reports.
","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': ""D'Agostini"", 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands; Research Group of Health Psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Karos', 'Affiliation': 'Research Group of Health Psychology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Hanne P J', 'Initials': 'HPJ', 'LastName': 'Kindermans', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Linda M G', 'Initials': 'LMG', 'LastName': 'Vancleef', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands. Electronic address: l.vancleef@maastrichtuniversity.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.03.008']
784,30741856,Exercise Supervision Is Important for Cardiometabolic Health Improvements: A 16-Week Randomized Controlled Trial.,"Hunter, JR, Gordon, BA, Bird, SR, and Benson, AC. Exercise supervision is important for cardiometabolic health improvements: a 16-week randomized controlled trial. J Strength Cond Res 34(3): 866-877, 2020-Exercise supervision enhances health and fitness improvements in clinical populations compared with unsupervised or home-based exercise, but effects of supervision type are unknown in healthy employees. Eighty-five Australian university employees (62 females; mean ± SD 43.2 ± 9.8 years) were randomized to personal (1:1; SUP, n = 28), nonpersonal (typical gym-based; NPS, n = 28) supervision or unsupervised control (CON, n = 29) exercise groups. Subjects received a 16-week individually tailored, moderate-to-high intensity aerobic and resistance exercise program completed at an onsite exercise facility (SUP and NPS) or without access to a specific exercise facility (CON). Repeated-measures ANOVA analyzed changes to cardiometabolic outcomes. Mean ± SD increases to V[Combining Dot Above]O2 peak were greater (p < 0.01) with SUP (+10.4 ± 11.1%) vs. CON (+3.8 ± 8.9%) but not different to NPS (+8.6 ± 8.2%). Compared to CON (+1.7 ± 7.7%), upper-body strength increases were greater with SUP (+12.8 ± 8.4%; p < 0.001) and NPS (+8.4 ± 7.3%; p < 0.05). Lower-body strength increases were greater with SUP (+26.3 ± 12.7%) vs. NPS (+15.0 ± 14.6%; p < 0.05) and CON (+4.1 ± 12.4%; p < 0.001), and NPS vs. CON (p < 0.01). Body fat reductions were greater with SUP (-2.2 ± 2.2%) vs. NPS (-0.6 ± 1.9%; p < 0.05) and CON (-0.7 ± 1.9%; p < 0.05). Access to an onsite exercise facility with personal or nonpersonal exercise supervision was important for improving several cardiometabolic outcomes, with greater improvements to lower-body strength and body composition from personal 1:1 exercise supervision.",2020,"Lower-body strength increases were greater with SUP (+26.3 ± 12.7%) vs. NPS (+15.0 ± 14.6%; p < 0.05) and CON (+4.1 ± 12.4%; p < 0.001), and NPS vs. CON (p < 0.01).",['Eighty-five Australian university employees (62 females; mean ± SD 43.2 ± 9.8 years'],"['CON', 'Exercise Supervision', 'J Strength Cond Res XX(X', '16-week individually tailored, moderate-to-high intensity aerobic and resistance exercise program completed at an onsite exercise facility (SUP and NPS) or without access to a specific exercise facility (CON', 'Exercise supervision', 'onsite exercise facility with personal or nonpersonal exercise supervision', 'nonpersonal (typical gym-based; NPS, n = 28) supervision or unsupervised control (CON, n = 29) exercise groups']","['Hunter, JR, Gordon, BA, Bird, SR, and Benson, AC', 'upper-body strength increases', 'Mean ± SD increases to V[Combining', 'several cardiometabolic outcomes', 'Lower-body strength', 'Dot Above]O2 peak', 'Cardiometabolic Health Improvements', 'Body fat reductions']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0187772,"Lower-body strength increases were greater with SUP (+26.3 ± 12.7%) vs. NPS (+15.0 ± 14.6%; p < 0.05) and CON (+4.1 ± 12.4%; p < 0.001), and NPS vs. CON (p < 0.01).","[{'ForeName': 'Jayden R', 'Initials': 'JR', 'LastName': 'Hunter', 'Affiliation': 'School of Exercise Science, Sport and Health, Charles Sturt University, New South Wales, Australia.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Gordon', 'Affiliation': 'Discipline of Exercise Physiology, La Trobe Rural Health School, La Trobe University, Victoria, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Bird', 'Affiliation': 'Discipline of Exercise Sciences, School of Health and Biomedical Sciences, RMIT University, Victoria, Australia.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Benson', 'Affiliation': 'Discipline of Exercise Sciences, School of Health and Biomedical Sciences, RMIT University, Victoria, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002980']
785,31089282,Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial.,"This study evaluates the physical and psychosocial effects of an inpatient exercise program for children and adolescents undergoing hematopoietic stem cell transplantation (HSCT). Participants (n = 70) were randomized to an exercise intervention (IG: resistance, endurance, and flexibility training) or a non-exercise control group (CG: mental and relaxation training). Pre- (prior hospital admission; T0) and post- (day of discharge; T1) measurements included maximal isometric knee extension strength (KES; strain gauge force transducer), hand grip strength (HGS; JAMAR dynamometer), distance walked in 6 min (6MWD; 6-minute walk test), quality of life (QoL; KINDL-R) and medical parameters. Fifty-seven patients (IG: n = 28; 11.0 (5-17) years; CG: n = 29; 12.0 (6-18) years) completed the study. During hospitalization the IG and CG attended on average 3.1 (2-4) or 2.9 (0.3-4) training sessions weekly. KES, 6MWD, and HGS significantly decreased (p < 0.05) in the CG, while there were no changes in the IG. Pre- to post-changes in 6MWD and HGS differed significantly between groups (p < 0.05). QoL declined in both groups (p < 0.05). Our results indicate that a moderate exercise program is feasible and might counteract a treatment-associated decline of physical performance.",2019,"KES, 6MWD, and HGS significantly decreased (p < 0.05) in the CG, while there were no changes in the IG.","['Participants (n\u2009=\u200970', 'children and adolescents undergoing hematopoietic stem cell transplantation (HSCT', 'Fifty-seven patients (IG: n\u2009=\u200928; 11.0 (5-17) years; CG: n\u2009=\u200929; 12.0 (6-18) years) completed the study', 'pediatric stem cell transplantation']","['Pre', 'inpatient exercise program', 'exercise therapy', 'exercise intervention (IG: resistance, endurance, and flexibility training) or a non-exercise control group (CG: mental and relaxation training', 'moderate exercise program']","['KES, 6MWD, and HGS', 'Psychophysical effects', 'maximal isometric knee extension strength (KES; strain gauge force transducer), hand grip strength (HGS; JAMAR dynamometer), distance walked in 6\u2009min (6MWD; 6-minute walk test), quality of life (QoL; KINDL-R) and medical parameters', 'QoL', '6MWD and HGS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0040661', 'cui_str': 'Transducers'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0034380'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.0397428,"KES, 6MWD, and HGS significantly decreased (p < 0.05) in the CG, while there were no changes in the IG.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Senn-Malashonak', 'Affiliation': 'Department of Pediatric Oncology, Hematology and Hemostaseology, Goethe University Hospital, Frankfurt am Main, Germany. anna.senn-malashonak@kgu.de.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Wallek', 'Affiliation': 'Department of Pediatric Oncology, Hematology and Hemostaseology, Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenhagen', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': 'Department for Stem Cell Transplantation and Immunology, Goethe University Hospital, Frankfurt am Main, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Sports Medicine, Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",Bone marrow transplantation,['10.1038/s41409-019-0535-z']
786,31624408,[Evaluation of modified micro-push-out bond strength of glass fiber posts with chemically treated resin cements].,"OBJECTIVE


To evaluate the modified micro-push-out bond strengths of prefabricated glass fiber posts with silaneafter 35% phosphoric acid to resin cements.
METHODS


In the study, 40 glass fiber posts were randomly divided into 2 groups (20 posts in each group) for different surface treatments. Group 1, treated with silaneafter 35% phosphoric acid; group 2, no surface treatment (Control group). Then each group was randomly divided into 2 minor groups (modified group and traditional group), with each group with 10. So the four groups were group 1M (phosphoric acid + silane-modified), group 1T (phosphoric acid + silane-traditional), group 2M (control-modified), and group 2T (control-traditional). A modified micro-push-out bond strength test method was used in modified groups. In traditional groups, the 20 extracted human, single-rooted teeth were endodontically treated. Gutta-percha was removed with #1-2 Peeso Reamers (Mani), and the post space of each specimen was enlarged with a standard drill system from the corresponding fiber post system to create a 9 mm post space with at least 4 mm of filling material in the root apex. Following post cementation according to the manufacturer's instructions, the traditional micro-push-out bond strengths were tested using a universal testing machine(0.5 mm/min). Both failure modes were examined with a stereomicroscope. The data of the four groups were statistically analyzed using the one-way ANOVA test(α= 0.05).
RESULTS


The bond strengths were (18.85±1.42) MPa for group 1M, (19.39±1.35) MPa for group 1T, (11.26±1.57) MPa for group 2M, and (11.27±1.83) MPa for group 2T. The bond strength of Group 1 was significantly higher than that of group 2(P<0.05), no matter which method was used. The fracture mode 100% in group M was the destruction of the post/resin interface, compared with 65.7% in group T.
CONCLUSION


In contrasted to the traditional micro-push-out test, the modified test can evaluate the bond strength of fiber post to resin cement more effectively, and 35% phosphate acid + silane treatment can improve the bonding strength.",2019,"The bond strength of Group 1 was significantly higher than that of group 2(P<0.05), no matter which method was used.",['40 glass fiber posts'],"['silaneafter 35% phosphoric acid', 'modified micro-push-out bond strength of glass fiber posts with chemically treated resin cements', 'phosphate acid + silane', 'M (phosphoric acid + silane-modified), group 1T (phosphoric acid + silane-traditional), group 2M (control-modified), and group 2T (control-traditional']","['bond strength', 'bonding strength']","[{'cui': 'C0060317', 'cui_str': 'glass fibers'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0060317', 'cui_str': 'glass fibers'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0376523', 'cui_str': 'Resin Cements'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0037093', 'cui_str': 'Silanes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0028758', 'cui_str': 'Object Relationship'}]",,0.0166445,"The bond strength of Group 1 was significantly higher than that of group 2(P<0.05), no matter which method was used.","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Second Clinical Division, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100101, China.'}, {'ForeName': 'X Z', 'Initials': 'XZ', 'LastName': 'Wang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
787,30696387,Exercise-Induced Alterations in Sympathetic-Somatomotor Coupling in Incomplete Spinal Cord Injury.,"The aim of this study was to understand how high- and low-intensity locomotor training (LT) affects sympathetic-somatomotor (SS) coupling in people with incomplete spinal cord injury (SCI). Proper coupling between sympathetic and somatomotor systems allows controlled regulation of cardiovascular responses to exercise. In people with SCI, altered connectivity between descending pathways and spinal segments impairs sympathetic and somatomotor coordination, which may have deleterious effects during exercise and limit rehabilitation outcomes. We postulated that high-intensity LT, which repeatedly engages SS systems, would alter SS coupling. Thirteen individuals (50 ± 7.2 years) with motor incomplete spinal cord injuries (American Spinal Injury Association Impairment Scale C or D; injury level >T6) participated in a locomotor treadmill training program. Patients were randomized into either a high-intensity (high-LT; 70-85% of maximum predicted heart rate;  n  = 6) group or a low-intensity (low-LT; 50-65% of maximum predicted heart rate;  n  = 7) group and completed up to 20 LT training sessions over 4-6 weeks, 3-5 days/week. Before and after taining, we tested SS coupling by eliciting reflexive sympathetic activity through a cold stimulation, noxious stimulation, and a mental math task while we measured tendon reflexes, blood pressure, and heart rate. Participants who completed high- versus low-LT exhibited significant decreases in reflex torques during triggered sympathetic activity (cold: -83 vs. 13%,  p  < 0.01; pain: -65 vs. 54%,  p  < 0.05; mental math: -43 vs. 41%;  p  < 0.05). Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant. These results suggest that high-LT may be advantageous to low-LT to improve SS coupling in people with incomplete SCI.",2019,"Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant.","['people with incomplete spinal cord injury (SCI', 'Thirteen individuals (50\u2009±\u20097.2 years) with motor incomplete spinal cord injuries (American Spinal Injury Association Impairment Scale C or D; injury level >T6) participated in a']","['locomotor treadmill training program', 'high- and low-intensity locomotor training (LT']","['tendon reflexes, blood pressure, and heart rate', 'reflex torques during triggered sympathetic activity', 'Mean arterial pressure responses to sympathetic stimuli', 'mental math']","[{'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4720884', 'cui_str': 'American Spinal Injury Association impairment scale (assessment scale)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}]","[{'cui': 'C0034943', 'cui_str': 'Reflex, Tendon'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0799656,"Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Onushko', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, Milwaukee, Wisconsin.'}, {'ForeName': 'Gordhan B', 'Initials': 'GB', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Brazg', 'Affiliation': 'Shirley Ryan AbilityLab, Chicago, Illinois.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Department of Biomedical Engineering, Marquette University, Milwaukee, Wisconsin.'}]",Journal of neurotrauma,['10.1089/neu.2018.5719']
788,31688909,Feasibility of a Habit Formation Intervention to Delay Frailty Progression Among Older African Americans: A Pilot Study.,"BACKGROUND AND OBJECTIVES


Older African Americans are at high risk for becoming frail in later life. Interventions can reverse or delay frailty, yet African Americans have largely been excluded from such research. Many interventions are also time- and resource-intensive, and thus inaccessible to socially disadvantaged older African Americans. We evaluated the feasibility of a low-dose frailty prevention intervention integrated with primary care among 60 community-dwelling, prefrail older African Americans aged 55+ recruited from a primary care clinic.
RESEARCH DESIGN AND METHODS


We conducted a 2-arm randomized control trial. Participants were assigned to a 4-session intervention (1 session per month), delivered by an occupational therapist, or enhanced usual care. Feasibility criteria were set a priori at 75% for participant retention (including attrition due to death/hospitalization), 80% for session engagement, 2 participants/week for mean participant accrual, and 90% for program satisfaction.
RESULTS


Participants were 65% female with an average age of 76.6 years, 51.7% lived alone and 39.1% reported <$10,000 in yearly income. Feasibility metrics were met. The study recruited, a mean of, 2.5 participants per week and retained 75% of participants who attended 95% of scheduled sessions. The mean satisfaction score was 29.75 (range = 0-32; SD .25). Changes in physical activity and dietary habit formation as well as changes in secondary outcomes were largely in the expected direction.
DISCUSSION AND IMPLICATIONS


The intervention was feasible to deliver. Qualitative findings from exit interviews suggested changes to the program dose, structure, and content that could improve it for future use.",2020,"Qualitative findings from exit interviews suggested changes to the program dose, structure, and content that could improve it for future use.","['60 community-dwelling, prefrail older African Americans aged 55+ recruited from a primary care clinic', 'The study recruited, a mean of, 2.5 participants per week and retained 75% of participants who attended 95% of scheduled sessions', 'Older African Americans', 'socially disadvantaged older African Americans', 'Participants were 65% female with an average age of 76.6 years, 51.7% lived alone and 39.1% reported <$10,000 in yearly income']","['low-dose frailty prevention intervention integrated with primary care', '4-session intervention (1 session per month), delivered by an occupational therapist, or enhanced usual care', 'Habit Formation Intervention']","['physical activity and dietary habit formation', 'mean satisfaction score']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1634625', 'cui_str': 'Percent live'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0288606,"Qualitative findings from exit interviews suggested changes to the program dose, structure, and content that could improve it for future use.","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Fritz', 'Affiliation': 'Institute of Gerontology, Detroit, Michigan.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Hu', 'Affiliation': 'Institute of Gerontology, Detroit, Michigan.'}, {'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'Tarraf', 'Affiliation': 'Institute of Gerontology, Detroit, Michigan.'}, {'ForeName': 'Pragnesh', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'School of Medicine, Wayne State University, Detroit, Michigan.'}]",The Gerontologist,['10.1093/geront/gnz143']
789,32408038,Does eccentric-concentric resistance training improve early functional outcomes compared to concentric resistance training after total knee arthroplasty?,"BACKGROUND


Total knee arthroplasty (TKA) is the preferred surgical treatment of end stage osteoarthritis of the knee. However, up to 20% of patients are dissatisfied after TKA. Moreover, kinesiophobia is negatively correlated with functional outcomes.
RESEARCH QUESTION


The aim of this study was to compare the effects of combined concentric-eccentric versus concentric program on muscular strength assessment and quality of life, after total knee arthroplasty in elderly people.
METHOD


A prospective study including 20 subjects (72.1 ± 6.3 years), following a rehabilitation program after TKA was performed. Subjects were randomized in combined eccentricconcentric (ECC-CON, n = 10) versus concentric (CN, n = 10) early rehabilitation protocols. There were no significant differences between groups with respect to demographic data. Data were collected before and after protocol: performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life (Lequesne-ISK, WOMAC, OAKHQOL) and kinesiophobia assessment (TSK-CF). The Gaussian distribution for the whole population of this study was tested by a Kolmogorov-Smirnov test. Statistical analysis was performed using non-parametric Mann-Whitney U or Fisher's exact probability test, as appropriate.
RESULTS AND CONCLUSION


Performance-based physical function tests showed a significant improvement after early rehabilitation in the ECC-CON group for timed up and go (p = 0.0002) and 10-meter walk test (p = 0.001). Operated hamstring muscle peak torque was significantly improved in the ECC-CON group (p = 0.03). Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04). Self-reported kinesiophobia significantly decreased after rehabilitation in both groups (p = 0.01) whilst there were no differences between groups. Early combined eccentric-concentric rehabilitation after TKA appears to be associated with improved outcomes compared to classic concentric rehabilitation protocols, on both physical function and quality of life. This information is new. Assessment and care of kinesiophobia should be considered in rehabilitation protocols standards.",2020,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"['elderly people', '20 subjects (72.1\u202f±\u202f6.3 years), following a rehabilitation program after TKA was performed']","['combined concentric-eccentric versus concentric program', 'Total knee arthroplasty (TKA', 'concentric resistance training', 'eccentric-concentric resistance training', 'combined eccentricconcentric (ECC-CON, n\u202f=\u202f10) versus concentric (CN, n\u202f=\u202f10) early rehabilitation protocols', 'ECC-CON']","['Self-reported kinesiophobia', 'physical function and quality of life', 'Operated hamstring muscle peak torque', 'performance-based physical function (timed up and go test, 10-meter walk test, isokinetic assessment), Selfreported physical function and quality of life ', 'muscular strength assessment and quality of life', 'Self-reported physical function and quality of life tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",20.0,0.023474,Self-reported physical function and quality of life tests were significantly better in the ECC-CON group for ISK (p = 0.03) and WOMAC (p = 0.04).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Teissier', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Department of Orthopaedic Surgery, Hospital Cochin, APHP, Université Paris 5, Paris, France. Electronic address: vic.teissier@gmail.com.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Leclercq', 'Affiliation': ""Université d'Orléans, COST, 45100, Orléans, France. Electronic address: apa.olivet@orpea.net.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Schiano-Lomoriello', 'Affiliation': 'Université Orléans, CIAMS, 45067, Orléans, France; CIAMS, Université Paris-Sud, Université Paris-Saclay, 91405, Orsay Cedex, France. Electronic address: sandrine.schiano-lomoriello@univ-orleans.fr.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Nizard', 'Affiliation': 'Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; 6-AP-HP, Hôpital Lariboisière, Service de chirurgie orthopédique, F-75010, Paris, France. Electronic address: remy.nizard@aphp.fr.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Portier', 'Affiliation': ""Université Paris, Laboratoire de Biologie Bioingénierie et Bioimagerie Ostéo-Articulaire (B3OA), UMR CNRS 7052, INSERM U1273, 10 Av de Verdun, 75010, Paris, France; Université d'Orléans, COST, 45100, Orléans, France. Electronic address: hugues.portier@univ-orleans.fr.""}]",Gait & posture,['10.1016/j.gaitpost.2020.04.020']
790,30858012,Cardiometabolic Adverse Effects and Its Predictors in Children and Adolescents With First-Episode Psychosis During Treatment With Quetiapine-Extended Release Versus Aripiprazole: 12-Week Results From the Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA) Trial.,"OBJECTIVE


To investigate cardiometabolic effects and their predictors in youths with first-episode psychosis (FEP) treated with quetiapine-extended release (ER) versus aripiprazole.
METHOD


Youths with FEP who were 12 to 17 years of age were randomized to quetiapine-ER or aripiprazole in the 12-week, double-blinded, Tolerability and Efficacy of Antipsychotics (TEA) trial. Primary outcome was change in body weight; secondary outcomes were changes in body mass index (BMI) and waist circumference (WC), blood pressure (BP), heart rate, and lipid and glucose metabolism parameters. Possible predictors of cardiometabolic changes were examined.
RESULTS


Altogether, 113 patients (schizophrenia-spectrum disorders = 93%; age [mean ± SD] = 15.7 ± 1.4 years; male participants = 30.1%) were randomized to quetiapine-ER (n = 55) or aripiprazole (n = 58). Quetiapine-ER led to significant increases in body weight (4.88 kg, 95% CI = 3.92-5.83, p < .0001), BMI z-score (0.43, 95% CI = 0.33-0.53, p < .0001), and WC z-score (0.97, CI = 0.7-1.23, p < .0001). Changes were significantly smaller with aripiprazole (all between-group p values <.0001): body weight: 1.97 kg (CI = 0.97-2.97, p = .0001), BMI z-score: 0.10 (CI = -0.01 to 0.20, p = .0646), and WC z-score: 0.18 (CI = -0.09 to 0.45, p = .1968). Lipid and glucose metabolism parameters increased significantly at week 4 and week 12 only with quetiapine-ER (p range = 0.0001-0.037). Quetiapine-ER was associated with an increased occurrence of obesity, elevated blood lipids and hyperinsulinemia (p range = 0.004-0.039). Early weight gain, obesity, or type 2 diabetes in the family significantly predicted weight and BMI gain at week 12.
CONCLUSION


In youths with FEP, quetiapine-ER was associated with significantly greater weight gain and adverse changes in metabolic outcomes than was aripiprazole. Early weight gain must be addressed and family lifestyle factors taken into consideration when treating youths with antipsychotics.
CLINICAL TRIAL REGISTRATION INFORMATION


Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA); https://clinicaltrials.gov; NCT01119014.",2019,Lipid and glucose metabolism parameters increased significantly at week 4 and week 12 only with quetiapine-ER (p range = 0.0001-0.037).,"['113 patients (schizophrenia-spectrum disorders\xa0= 93%; age [mean ± SD]\xa0= 15.7 ± 1.4 years; male participants\xa0= 30.1', 'Children and Adolescents With Psychosis (TEA', 'Youths with FEP who were 12 to 17 years of age', 'Children and Adolescents With First-Episode Psychosis During Treatment With', 'youths with first-episode psychosis (FEP) treated with', 'Children and Adolescents With Psychosis (TEA) Trial']","['quetiapine-extended release (ER) versus aripiprazole', 'Antipsychotics (TEA', 'quetiapine-ER', 'quetiapine-ER or aripiprazole', 'Quetiapine-ER', 'Quetiapine-Extended Release Versus Aripiprazole', 'aripiprazole', 'Antipsychotics']","['Early weight gain, obesity, or type 2 diabetes', 'weight gain and adverse changes in metabolic outcomes', 'weight and BMI gain', 'BMI z-score', 'change in body weight; secondary outcomes were changes in body mass index (BMI) and waist circumference (WC), blood pressure (BP), heart rate, and lipid and glucose metabolism parameters', 'WC z-score', 'Lipid and glucose metabolism parameters', 'occurrence of obesity, elevated blood lipids and hyperinsulinemia', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}]",113.0,0.121064,Lipid and glucose metabolism parameters increased significantly at week 4 and week 12 only with quetiapine-ER (p range = 0.0001-0.037).,"[{'ForeName': 'Karsten Gjessing', 'Initials': 'KG', 'LastName': 'Jensen', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: karsten.gjessing.jensen@regionh.dk.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Hofstra Northwell School of Medicine and The Zucker Hillside Hospital, New York, NY, and the Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Ditte', 'Initials': 'D', 'LastName': 'Rudå', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Dea Gowers', 'Initials': 'DG', 'LastName': 'Klauber', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Marie Stentebjerg', 'Initials': 'MS', 'LastName': 'Decara', 'Affiliation': 'Psychiatric Centre Copenhagen, Capital Region of Denmark, Copenhagen, Denmark, and the Laboratory of Neuropsychiatry, University of Copenhagen, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Fagerlund', 'Affiliation': 'Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), and Center for Neuropsychiatric Schizophrenia Research (CNSR), Copenhagen University Hospital, Mental Health Services, Capital Region of Denmark.'}, {'ForeName': 'Jens Richardt Møllegaard', 'Initials': 'JRM', 'LastName': 'Jepsen', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Lundbeck Foundation Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), and Center for Neuropsychiatric Schizophrenia Research (CNSR), Copenhagen University Hospital, Mental Health Services, Capital Region of Denmark.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eriksson', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Fink-Jensen', 'Affiliation': 'Psychiatric Centre Copenhagen, Capital Region of Denmark, Copenhagen, Denmark, and the Laboratory of Neuropsychiatry, University of Copenhagen, Denmark.'}, {'ForeName': 'Anne Katrine', 'Initials': 'AK', 'LastName': 'Pagsberg', 'Affiliation': 'Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.01.015']
791,31878845,The effect of mother-infant skin-to-skin contact on the involution process and maternal postpartum fatigue during the early postpartum period.,"Evidence has been limited on the effect of mother-infant skin-to-skin contact on the involution process and maternal postpartum fatigue. This study aimed to determine such effects in a randomized controlled trial conducted in a hospital in Sivas, Turkey. Seventy-five women were randomized into one of two groups. The Mother-Infant Information Form, Involution Process Evaluation Form and Visual Analogue Scale for Fatigue were used to collect data between October 1, 2015 and May 1, 2016. Repeated Measures ANOVAs were used for data analyzes. In the intervention group, routine care and mother-to-infant skin-to-skin contact were provided for 30 minutes in first postnatal hour. In the control group, routine care was provided. At the postnatal second, fourth and 24th hours, fundus heights were 13.4 ± 0.3, 12.9 ± 0.3 and 11.8 ± 0.3 cm, respectively, in the intervention group, and 14.4 ± 0.4, 13.8 ± 0.3 and 12.9 ± 0.3 cm in the control group ( p  < .05). At the 24th hour, women in the intervention group had higher mean energy levels (29.8 ± 10.1) than the control group (25.1 ± 10.0) ( p  < .05), and fatigue score, amount of lochia and number of pads were statistically similar between the groups ( p  > .05). Mothers expressed satisfaction with skin-to-skin practice. Thus, mother-to-infant skin-to-skin contact can be used as a care practice in the postpartum period.",2020,"At the 24th hour, women in the intervention group had higher mean energy levels (29.8 ± 10.1) than the control group (25.1 ± 10.0) ( p  < .05), and fatigue score, amount of lochia and number of pads were statistically similar between the groups ( p  > .05).","['Seventy-five women', 'hospital in Sivas, Turkey']","['routine care and mother-to-infant skin-to-skin contact', 'mother-infant skin-to-skin contact']","['mean energy levels', 'maternal postpartum fatigue', 'fatigue score, amount of lochia and number of pads']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0227855', 'cui_str': 'Lochia (substance)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}]",75.0,0.0411448,"At the 24th hour, women in the intervention group had higher mean energy levels (29.8 ± 10.1) than the control group (25.1 ± 10.0) ( p  < .05), and fatigue score, amount of lochia and number of pads were statistically similar between the groups ( p  > .05).","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Tosun Güleroğlu', 'Affiliation': 'Faculty of Health Sciences, Yozgat Bozok University , Yozgat, Turkey.'}, {'ForeName': 'Salime', 'Initials': 'S', 'LastName': 'Mucuk', 'Affiliation': 'Faculty of Health Sciences, University of Erciyes , Kayseri, Turkey.'}, {'ForeName': 'İzzet', 'Initials': 'İ', 'LastName': 'Özgürlük', 'Affiliation': 'Gynecology, Dr. Abdurrahman Yurtarslan Oncology Education and Research Hospital , Ankara, Turkey.'}]",Women & health,['10.1080/03630242.2019.1707747']
792,30694322,Effect of Hydrocortisone Therapy Initiated 7 to 14 Days After Birth on Mortality or Bronchopulmonary Dysplasia Among Very Preterm Infants Receiving Mechanical Ventilation: A Randomized Clinical Trial.,"Importance


Dexamethasone initiated after the first week of life reduces the rate of death or bronchopulmonary dysplasia (BPD) but may cause long-term adverse effects in very preterm infants. Hydrocortisone is increasingly used as an alternative, but evidence supporting its efficacy and safety is lacking.
Objective


To assess the effect of hydrocortisone initiated between 7 and 14 days after birth on death or BPD in very preterm infants.
Design, Setting, and Participants


Double-blind, placebo-controlled randomized trial conducted in 19 neonatal intensive care units in the Netherlands and Belgium from November 15, 2011, to December 23, 2016, among preterm infants with a gestational age of less than 30 weeks and/or birth weight of less than 1250 g who were ventilator dependent between 7 and 14 days of life, with follow-up to hospital discharge ending December 12, 2017.
Interventions


Infants were randomly assigned to receive a 22-day course of systemic hydrocortisone (cumulative dose, 72.5 mg/kg) (n = 182) or placebo (n = 190).
Main Outcomes and Measures


The primary outcome was a composite of death or BPD assessed at 36 weeks' postmenstrual age. Twenty-nine secondary outcomes were analyzed up to hospital discharge, including death and BPD at 36 weeks' postmenstrual age.
Results


Among 372 patients randomized (mean gestational age, 26 weeks; 55% male), 371 completed the trial; parents withdrew consent for 1 child treated with hydrocortisone. Death or BPD occurred in 128 of 181 infants (70.7%) randomized to hydrocortisone and in 140 of 190 infants (73.7%) randomized to placebo (adjusted risk difference, -3.6% [95% CI, -12.7% to 5.4%]; adjusted odds ratio, 0.87 [95% CI, 0.54-1.38]; P = .54). Of 29 secondary outcomes, 8 showed significant differences, including death at 36 weeks' postmenstrual age (15.5% with hydrocortisone vs 23.7% with placebo; risk difference, -8.2% [95% CI, -16.2% to -0.1%]; odds ratio, 0.59 [95% CI, 0.35-0.995]; P = .048). Twenty-one outcomes showed nonsignificant differences, including BPD (55.2% with hydrocortisone vs 50.0% with placebo; risk difference, 5.2% [95% CI, -4.9% to 15.2%]; odds ratio, 1.24 [95% CI, 0.82-1.86]; P = .31). Hyperglycemia requiring insulin therapy was the only adverse effect reported more often in the hydrocortisone group (18.2%) than in the placebo group (7.9%).
Conclusions and Relevance


Among mechanically ventilated very preterm infants, administration of hydrocortisone between 7 and 14 days after birth, compared with placebo, did not improve the composite outcome of death or BPD at 36 weeks' postmenstrual age. These findings do not support the use of hydrocortisone for this indication.
Trial Registration


Netherlands National Trial Register Identifier: NTR2768.",2019,"Death or BPD occurred in 128 of 181 infants (70.7%) randomized to hydrocortisone and in 140 of 190 infants (73.7%) randomized to placebo (adjusted risk difference, -3.6%","['very preterm infants', 'Interventions\n\n\nInfants', '372 patients randomized (mean gestational age, 26 weeks; 55% male', '19 neonatal intensive care units in the Netherlands and Belgium from November 15, 2011, to December 23, 2016, among preterm infants with a gestational age of less than 30 weeks', 'and/or birth weight of less than 1250 g who were ventilator dependent between 7 and 14 days of life, with follow-up to hospital discharge ending December 12, 2017', 'mechanically ventilated very preterm infants']","['placebo', 'Dexamethasone', 'hydrocortisone', 'Hydrocortisone', 'Mechanical Ventilation', 'systemic hydrocortisone']","['death', 'composite outcome of death or BPD', 'composite of death or BPD', 'Hyperglycemia requiring insulin therapy', 'Death or BPD', 'hospital discharge, including death and BPD', 'rate of death or bronchopulmonary dysplasia (BPD', 'BPD', 'death or BPD']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}]",372.0,0.77,"Death or BPD occurred in 128 of 181 infants (70.7%) randomized to hydrocortisone and in 140 of 190 infants (73.7%) randomized to placebo (adjusted risk difference, -3.6%","[{'ForeName': 'Wes', 'Initials': 'W', 'LastName': 'Onland', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.""}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Cools', 'Affiliation': 'Department of Neonatology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Kroon', 'Affiliation': 'Department of Neonatology, Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Rademaker', 'Affiliation': 'Department of Neonatology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Maruschka P', 'Initials': 'MP', 'LastName': 'Merkus', 'Affiliation': 'Clinical Research Unit, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Dijk', 'Affiliation': ""Department of Neonatology, University Medical Center Groningen, Beatrix Children's Hospital, University of Groningen, Groningen, the Netherlands.""}, {'ForeName': 'Henrica L', 'Initials': 'HL', 'LastName': 'van Straaten', 'Affiliation': 'Department of Neonatology, Isala Medical Center, Zwolle, the Netherlands.'}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Mohns', 'Affiliation': 'Department of Neonatology, Maxima Medical Center, Veldhoven, the Netherlands.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Bruneel', 'Affiliation': 'Department of Neonatology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Arno F', 'Initials': 'AF', 'LastName': 'van Heijst', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center-Amalia Children's Hospital, Nijmegen, the Netherlands.""}, {'ForeName': 'Boris W', 'Initials': 'BW', 'LastName': 'Kramer', 'Affiliation': 'Department of Neonatology, Medical University Center Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Debeer', 'Affiliation': 'Department of Neonatology, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Zonnenberg', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Vrije Universteit Amsterdam, Amsterdam, the Netherlands.""}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Marechal', 'Affiliation': 'Department of Neonatology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Blom', 'Affiliation': 'Department of Neonatology, Universitair Ziekenhuis Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Plaskie', 'Affiliation': 'Department of Neonatology, St Augustinus Ziekenhuis, Antwerp, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.""}, {'ForeName': 'Anton H', 'Initials': 'AH', 'LastName': 'van Kaam', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2018.21443']
793,31856760,Effect of low dose naloxone on the immune system function of a patient undergoing video-assisted thoracoscopic resection of lung cancer with sufentanil controlled analgesia - a randomized controlled trial.,"BACKGROUND


Perioperative immune function plays an important role in the prognosis of patients. Several studies have indicated that low-dose opioid receptor blockers can improve immune function.
METHODS


Sixty-nine patients undergoing video-assisted thoracoscopic resection of the lung cancer were randomly assigned to either the naloxone group (n = 35) or the non-naloxone group (n = 34) for postoperative analgesia during the first 48 h after the operation. Both groups received sufentanil and palonosetron via postoperative analgesia pump, while 0.05 μg·kg - 1 ·h - 1  naloxone was added in naloxone group. The primary outcomes were the level of opioid growth factor (OGF) and immune function assessed by natural killer cells and CD4 + /CD8 +  T-cell ratio. Second outcomes were assessed by the intensity of postoperative pain, postoperative rescue analgesia dose, postoperative nausea and vomiting (PONV).
RESULTS


The level of OGF in the naloxone group increased significantly at 24 h (p<0.001) and 48 h after the operation (P < 0.01). The natural killer cells (P < 0.05) and CD4 + /CD8 +  T-cell ratio (P < 0.01) in the naloxone group increased significantly at 48 h after the operation. The rest VAS scores were better with naloxone at 12 and 24 h after operation(P < 0.05), and the coughing VAS scores were better with naloxone at 48 h after the operation(P < 0.05). The consumption of postoperative rescue analgesics in the naloxone group was lower (0.00(0.00-0.00) vs 25.00(0.00-62.50)), P < 0.05). Postoperative nausea scores at 24 h after operation decreased in naloxone group(0.00 (0.00-0.00) vs 1.00 (0.00-2.00), P < 0.01).
CONCLUSION


Infusion of 0.05 μg·kg - 1 ·h - 1  naloxone for patients undergoing sufentanil-controlled analgesia for postoperative pain can significantly increase the level of OGF, natural killer cells, and CD4+/CD8+ T-cell ratio compared with non-naloxone group, and postoperative pain intensity, request for rescue analgesics, and opioid-related side effects can also be reduced.
TRIAL REGISTRATION


The trial was registered at the Chinese Clinical Trial Registry on January 26, 2019 (ChiCTR1900021043).",2019,The natural killer cells (P < 0.05) and CD4 + /CD8 +  T-cell ratio (P < 0.01) in the naloxone group increased significantly at 48 h after the operation.,"['Sixty-nine patients undergoing', 'patients undergoing', 'patient undergoing video-assisted thoracoscopic resection of lung cancer with', 'of the lung cancer']","['sufentanil-controlled analgesia', 'sufentanil and palonosetron via postoperative analgesia pump, while 0.05\u2009μg·kg -\u20091 ·h -\u20091  naloxone', 'naloxone', 'video-assisted thoracoscopic resection', 'naloxone group (n\u2009=\u200935) or the non-naloxone', 'sufentanil controlled analgesia']","['level of opioid growth factor (OGF) and immune function assessed by natural killer cells and CD4 + /CD8 +  T-cell ratio', 'consumption of postoperative rescue analgesics', 'level of OGF', 'coughing VAS scores', 'postoperative pain intensity, request for rescue analgesics, and opioid-related side effects', 'rest VAS scores', 'level of OGF, natural killer cells, and CD4+/CD8+ T-cell ratio', 'natural killer cells', 'CD4 + /CD8 +  T-cell ratio', 'Postoperative nausea scores', 'intensity of postoperative pain, postoperative rescue analgesia dose, postoperative nausea and vomiting (PONV']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",69.0,0.0888692,The natural killer cells (P < 0.05) and CD4 + /CD8 +  T-cell ratio (P < 0.01) in the naloxone group increased significantly at 48 h after the operation.,"[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, No.193 Lian he Road, Xi gang District, Dalian City, Liaoning Province, 116000, People's Republic of China.""}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, No.193 Lian he Road, Xi gang District, Dalian City, Liaoning Province, 116000, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, No.193 Lian he Road, Xi gang District, Dalian City, Liaoning Province, 116000, People's Republic of China.""}, {'ForeName': 'Fang-Fang', 'Initials': 'FF', 'LastName': 'Ge', 'Affiliation': 'Dalian Medical of University, Dalian, China.'}, {'ForeName': 'Qing-Ping', 'Initials': 'QP', 'LastName': 'Wen', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, No.193 Lian he Road, Xi gang District, Dalian City, Liaoning Province, 116000, People's Republic of China. wqp.89@163.com.""}]",BMC anesthesiology,['10.1186/s12871-019-0912-6']
794,30429735,"Comparative evaluation of analgesic sparing efficacy between dexmedetomidine and clonidine used as adjuvant to ropivacaine in thoracic paravertebral block for patients undergoing breast cancer surgery: A prospective, randomized, double-blind study.","Introduction


Thoracic paravertebral block (TPVB) is an effective method for intra- and post-operative pain management in thoracic surgeries. For a long time, various adjuvants have been tried for prolonging the duration of TPVB.
Objective


In this prospective study, we have compared the analgesic sparing efficacy of dexmedetomidine and clonidine, two α 2  adrenergic agonists, administered along with ropivacaine for TPVB for breast cancer surgery patients.
Materials and Methods


Forty-four breast cancer surgery patients undergoing general anesthesia (GA) were randomly divided into Group C and Group D ( n  = 44 each) receiving preoperative TPVB at T 3-5  level with 0.5% ropivacaine solution admixture with clonidine and dexmedetomidine, respectively. Cancer surgery was performed under GA. Intraoperative fentanyl and propofol requirement was compared. Visual analogue scale was used for pain assessment. Total dose and mean time to administration of first rescue analgesic diclofenac sodium was noted. Side effects and hemodynamic parameters were also noted.
Results


Intraoperative fentanyl and propofol requirement was significantly less in dexmedetomidine group than clonidine. The requirement of diclofenac sodium was also significantly less and later in Group D than Group C. Hemodynamics, and side effects were comparable among two groups.
Conclusion


Dexmedetomidine provided better intraoperative as well as postoperative analgesia than clonidine when administered with ropivacaine in TPVB before breast cancer surgery patients without producing remarkable side effects.",2018,"The requirement of diclofenac sodium was also significantly less and later in Group D than Group C. Hemodynamics, and side effects were comparable among two groups.
","['patients undergoing breast cancer surgery', 'Materials and Methods\n\n\nForty-four breast cancer surgery patients undergoing general anesthesia (GA', 'TPVB before breast cancer surgery patients', 'breast cancer surgery patients']","['ropivacaine solution admixture with clonidine and dexmedetomidine', 'Dexmedetomidine', 'Intraoperative fentanyl and propofol', 'diclofenac sodium', 'dexmedetomidine and clonidine', 'clonidine', 'ropivacaine', 'dexmedetomidine', 'Introduction\n\n\nThoracic paravertebral block (TPVB']","['Visual analogue scale', 'Total dose and mean time to administration of first rescue analgesic diclofenac sodium', 'side effects', 'Side effects and hemodynamic parameters', 'postoperative analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",44.0,0.0466257,"The requirement of diclofenac sodium was also significantly less and later in Group D than Group C. Hemodynamics, and side effects were comparable among two groups.
","[{'ForeName': 'Anindya', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Nairita', 'Initials': 'N', 'LastName': 'Mayur', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Chiranjib', 'Initials': 'C', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Anaesthesiology, IPGMER, Kolkata, West Bengal, India.'}, {'ForeName': 'Hirak', 'Initials': 'H', 'LastName': 'Biswas', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Roybasunia', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'Subrata Kumar', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_81_18']
795,31654645,Comparison of Low Pre-Emptive Oral Doses of Celecoxib Versus Acetaminophen for Postoperative Pain Management After Third Molar Surgery: A Randomized Controlled Study.,"PURPOSE


This study aimed to compare the pre-emptive analgesia of oral celecoxib with oral acetaminophen after surgical removal of the mandibular third molars.
MATERIALS AND METHODS


A randomized, double-blinded, placebo-controlled clinical trial was conducted to examine patients presenting with a mandibular third molar for extraction under local anesthesia. The participants were randomized to receive a preoperative oral dose of celecoxib or acetaminophen as the predictor variable. The primary outcome variable was postoperative pain measured on a visual analog scale at different time points. The secondary outcome variable was the amount of postoperative analgesic medication taken in both groups. Statistical analyses included descriptive statistics, the t test, and the Pearson χ 2  test. Significance was set at P < .05. The overall survival (interval to the first intake of ibuprofen) of the patients in each group was evaluated using Kaplan-Meier curves and log-rank analyses.
RESULTS


Sixty participants were randomly divided into either the celecoxib group or acetaminophen group. The postoperative pain scores in the celecoxib group were significantly lower than those in the acetaminophen group at 4, 6, 8, and 12 hours (P = .008, P = .001, P = .021, and P = .011, respectively). The number of patients who did not require analgesics in the celecoxib group was less than that in the acetaminophen group (P = .018). The average amount of rescue analgesic medication in the celecoxib group (0.6 ± 0.8 dose) was significantly lower than that in the acetaminophen group (1.3 ± 1.0 doses) (P = .002). The Kaplan-Meier curve indicated that celecoxib resulted in long-term survival of the patients who did not receive rescue analgesic medication (P = .0055).
CONCLUSIONS


Celecoxib exhibits a significant pre-emptive analgesic effect, thereby reducing the use of postoperative analgesics after removal of the third molar.",2020,"The postoperative pain scores in the celecoxib group were significantly lower than those in the acetaminophen group at 4, 6, 8, and 12 hours (P = .008, P = .001, P = .021, and P = .011, respectively).","['patients presenting with a mandibular third molar for extraction under local anesthesia', 'Sixty participants']","['Celecoxib', 'celecoxib or acetaminophen', 'Celecoxib Versus Acetaminophen', 'placebo', 'celecoxib', 'acetaminophen', 'Low Pre', 'celecoxib with oral acetaminophen']","['postoperative pain scores', 'overall survival', 'amount of postoperative analgesic medication taken', 'average amount of rescue analgesic medication', 'postoperative pain measured on a visual analog scale', 'Postoperative Pain Management']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.263955,"The postoperative pain scores in the celecoxib group were significantly lower than those in the acetaminophen group at 4, 6, 8, and 12 hours (P = .008, P = .001, P = .021, and P = .011, respectively).","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Attending Physician, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Rong-Tao', 'Initials': 'RT', 'LastName': 'Yang', 'Affiliation': 'Associate Professor, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lv', 'Affiliation': 'Associate Professor, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Hai-Hua', 'Initials': 'HH', 'LastName': 'Zhou', 'Affiliation': 'Associate Professor, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Chief Physician, State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST), Key Laboratory of Oral Biomedicine Ministry of Education, and Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: zhili@whu.edu.cn.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.022']
796,23965396,"BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial.","BACKGROUND


BMS-927711 is a potent, selective, competitive human calcitonin gene-related peptide (CGRP) receptor antagonist that has shown in vivo efficacy without vasoconstrictor effect. The objective of the current study was to determine an effective and tolerable dose range of BMS-927711 for the acute treatment of migraine.
METHODS


In this randomized, double-blind, placebo controlled, dose-ranging study, 885 patients were randomized using an adaptive design to one of the following dose groups: BMS-927711 (10, 25, 75, 150, 300, or 600 mg); sumatriptan 100 mg (active comparator); and placebo. Patients were treated for a single migraine attack. The primary endpoint was pain freedom at two hours post-dose.
RESULTS


Of patients who took the study drug, 799 had one post-randomization efficacy evaluation. Significantly more patients in the BMS-927711 75 mg (31.4%, P = 0.002), 150 mg (32.9%, P < 0.001), and 300 mg (29.7%, P = 0.002) groups and the sumatriptan group (35%, P < 0.001) had pain freedom at two hours post-dose versus placebo (15.3%). For the secondary endpoint of sustained pain freedom from two to 24 hours post-dose, BMS-927711 doses (25-600 mg) were also statistically significant compared with placebo. No deaths or treatment-related serious adverse events (AEs) were reported, and no patients discontinued because of AEs.
CONCLUSIONS


BMS-927711 is superior to placebo at several different doses (75 mg, 150 mg, and 300 mg) and has an excellent tolerability profile.",2014,"Significantly more patients in the BMS-927711 75 mg (31.4%, P = 0.002), 150 mg (32.9%, P < 0.001), and 300 mg (29.7%, P = 0.002) groups and the sumatriptan group (35%, P < 0.001) had pain freedom at two hours post-dose versus placebo (15.3%).","['Of patients who took the study drug', '885 patients', 'migraine']","['sumatriptan 100 mg (active comparator); and placebo', 'BMS-927711', 'placebo']","['deaths or treatment-related serious adverse events (AEs', 'sustained pain freedom', 'pain freedom', 'tolerability profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C1126059', 'cui_str': 'Sumatriptan 100 MG'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3657945', 'cui_str': '(5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta(b)pyridin-9-yl 4-(2-oxo-2,3-dihydro-1H-imidazo(4,5-b)pyridin-1-yl)piperidine-1-carboxylate'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]",885.0,0.549233,"Significantly more patients in the BMS-927711 75 mg (31.4%, P = 0.002), 150 mg (32.9%, P < 0.001), and 300 mg (29.7%, P = 0.002) groups and the sumatriptan group (35%, P < 0.001) had pain freedom at two hours post-dose versus placebo (15.3%).","[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Marcus', 'Affiliation': 'Bristol-Myers Squibb, Wallingford, CT, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dodick', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stock', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Manos', 'Affiliation': ''}, {'ForeName': 'Tanya Z', 'Initials': 'TZ', 'LastName': 'Fischer', 'Affiliation': ''}]",Cephalalgia : an international journal of headache,['10.1177/0333102413500727']
797,30732912,Exposure therapy vs lifestyle intervention to reduce food cue reactivity and binge eating in obesity: A pilot study.,"BACKGROUND AND OBJECTIVES


Learning models of overeating predict that exposure therapy is effective in reducing food cue reactivity and overeating. This pilot study tested an eight-session exposure therapy aimed at inhibitory learning vs. an active control condition aimed at lifestyle improvement for obesity (treatment-as-usual). Main outcomes are snacking behavior, eating psychopathology, food cue reactivity, and weight loss. Change in overeating expectancies was assessed as mediator for outcomes, and the associations between habituation of eating desires and outcomes were investigated in the exposure condition. Sleep quality was investigated as moderator for outcomes.
METHODS


45 overweight women were randomly assigned to the exposure intervention or control condition. The main outcomes, overeating expectancies and sleep quality were re-assessed at post-treatment and three-month follow-up. Habituation of eating desires was measured during exposure sessions.
RESULTS


Compared to the control intervention, exposure led to a significantly stronger reduction in snacking behavior of exposed foods, though this effect did not generalize to non-exposed foods, and stronger binge eating frequency. The exposure condition lost significantly more weight at post-treatment and follow-up than the lifestyle condition. Changes of expectancies mediated the effect of condition on kcal consumption of exposed foods, while habituation during exposure was not related to better treatment outcome. Sleep quality did not moderate the effect of condition on treatment outcome.
LIMITATIONS


Small sample size and limited follow-up period.
CONCLUSIONS


This short exposure therapy reduced snacking behavior, binge eating and weight more than a lifestyle intervention and is therefore a recommendable intervention for obesity and overeating disorders.",2020,"Compared to the control intervention, exposure led to a significantly stronger reduction in snacking behavior of exposed foods, though this effect did not generalize to non-exposed foods, and stronger binge eating frequency.",['45 overweight women'],"['exposure intervention or control condition', 'Exposure therapy vs lifestyle intervention']","['overeating expectancies and sleep quality', 'Habituation of eating desires', 'snacking behavior, eating psychopathology, food cue reactivity, and weight loss', 'food cue reactivity and binge eating in obesity', 'snacking behavior', 'snacking behavior, binge eating and weight', 'Sleep quality', 'overeating expectancies']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0020505', 'cui_str': 'Polyphagia'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",45.0,0.0373158,"Compared to the control intervention, exposure led to a significantly stronger reduction in snacking behavior of exposed foods, though this effect did not generalize to non-exposed foods, and stronger binge eating frequency.","[{'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Schyns', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. Electronic address: ghislaine.schyns@maastrichtuniversity.nl.'}, {'ForeName': 'Karolien', 'Initials': 'K', 'LastName': 'van den Akker', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Roefs', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Houben', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Jansen', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.01.005']
798,30665869,"Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations have poor prognosis. We aimed to establish the efficacy of ramucirumab in patients with advanced hepatocellular carcinoma and α-fetoprotein concentrations of 400 ng/mL or higher.
METHODS


REACH-2 was a randomised, double-blind, placebo-controlled, phase 3 trial done at 92 hospitals, clinics, and medical centres in 20 countries. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed hepatocellular carcinoma, or diagnosed cirrhosis and hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage B or C disease, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group (ECOG) performance statuses of 0 or 1, α-fetoprotein concentrations of 400 ng/mL or greater, and had previously received first-line sorafenib. Participants were randomly assigned (2:1) via an interactive web response system with a computer-generated random sequence to 8 mg/kg intravenous ramucirumab every 2 weeks or placebo. All patients received best supportive care. The primary endpoint was overall survival. Secondary endpoints were progression-free survival, proportion of patients achieving an objective response, time to radiographic progression, safety, time to deterioration in scores on the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8), and time to deterioration in ECOG performance status. We also pooled individual patient data from REACH-2 with data from REACH (NCT01140347) for patients with α-fetoprotein concentrations of 400 ng/mL or greater. Efficacy analyses were by intention to treat, whereas safety analyses were done in all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02435433.
FINDINGS


Between July 26, 2015, and Aug 30, 2017, 292 patients were randomly assigned, 197 to the ramucirumab group and 95 to the placebo group. At a median follow-up of 7·6 months (IQR 4·0-12·5), median overall survival (8·5 months [95% CI 7·0-10·6] vs 7·3 months [5·4-9·1]; hazard ratio [HR] 0·710 [95% CI 0·531-0·949]; p=0·0199) and progression-free survival (2·8 months [2·8-4·1] vs 1·6 months [1·5-2·7]; 0·452 [0·339-0·603]; p<0·0001) were significantly improved in the ramucirumab group compared with the placebo group. The proportion of patients with an objective response did not differ significantly between groups (nine [5%] of 197 vs one [1%] of 95; p=0·1697). Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups. Grade 3 or worse treatment-emergent adverse events that occurred in at least 5% of patients in either group were hypertension (25 [13%] in the ramucirumab group vs five [5%] in the placebo group), hyponatraemia (11 [6%] vs 0) and increased aspartate aminotransferase (six [3%] vs five [5%]). Serious adverse events of any grade and cause occurred in 68 (35%) patients in the ramucirumab group and 28 (29%) patients in the placebo group. Three patients in the ramucirumab group died from treatment-emergent adverse events that were judged to be related to study treatment (one had acute kidney injury, one had hepatorenal syndrome, and one had renal failure).
INTERPRETATION


REACH-2 met its primary endpoint, showing improved overall survival for ramucirumab compared with placebo in patients with hepatocellular carcinoma and α-fetoprotein concentrations of at least 400 ng/mL who had previously received sorafenib. Ramucirumab was well tolerated, with a manageable safety profile. To our knowledge, REACH-2 is the first positive phase 3 trial done in a biomarker-selected patient population with hepatocellular carcinoma.
FUNDING


Eli Lilly.",2019,Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups.,"['Between July 26, 2015, and Aug 30, 2017, 292 patients were randomly assigned, 197 to the ramucirumab group and 95 to the', 'patients with advanced hepatocellular carcinoma and α-fetoprotein concentrations of 400 ng/mL or higher', 'Patients with advanced hepatocellular carcinoma', 'patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2', 'patient population with hepatocellular carcinoma', '92 hospitals, clinics, and medical centres in 20 countries', 'Eligible patients were aged 18 years or older and had histologically or cytologically confirmed hepatocellular carcinoma, or diagnosed cirrhosis and hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage B or C disease, Child']","['placebo', 'ramucirumab', 'Pugh class', 'Ramucirumab after sorafenib', 'Ramucirumab', 'sorafenib', 'interactive web response system with a computer-generated random sequence to 8 mg/kg intravenous ramucirumab every 2 weeks or placebo']","['ECOG performance statuses', 'aspartate aminotransferase', 'Median time to deterioration in FHSI-8 total scores', 'proportion of patients with an objective response', 'hyponatraemia', 'progression-free survival', 'hypertension', 'renal failure', 'Grade 3 or worse treatment-emergent adverse events', 'progression-free survival, proportion of patients achieving an objective response, time to radiographic progression, safety, time to deterioration in scores on the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8), and time to deterioration in ECOG performance status', 'median overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0015950', 'cui_str': 'Fetoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C0441781', 'cui_str': 'Stage B (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",292.0,0.756414,Median time to deterioration in FHSI-8 total scores (3·7 months [95% CI 2·8-4·4] vs 2·8 months [1·6-2·9]; HR 0·799 [95% CI 0·545-1·171]; p=0·238) and ECOG performance statuses (HR 1·082 [95% CI 0·639-1·832]; p=0·77) did not differ between groups.,"[{'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Harvard Medical Center, Boston, MA, USA. Electronic address: azhu@mgh.harvard.edu.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital Tainan, Taiwan; College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'University Medical Center, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': ""Icahn School of Medicine at Mount Sinai, New York, NY, USA; Institut d'Investigations Biomèdiques, August Pi i Sunyer-Hospital Clinic Barcelona, Barcelona, Spain.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Assenat', 'Affiliation': 'CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'University Hospital S Orsola, Bologna, Italy.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pracht', 'Affiliation': 'Centre Eugene Marquis, Rennes, France.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Rau', 'Affiliation': 'Chang Gung Memorial Hospital-Kaohsiung Branch, Kaohsiung City, Taiwan; Hematology-Oncology Department, E-Da Cancer Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Aso Iizuka Hospital-Hepatology, Iizuka, Fukuoka, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Ohno', 'Affiliation': 'National Cancer Center Hospital East-Hepatobiliary and Pancreatic Oncology, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Azienda Ospedaliera G Rummo, Benevento, Benevento, Italy; Ospedale del Mare, Naples, Italy.'}, {'ForeName': 'Dong Bok', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gerken', 'Affiliation': 'Universtitätsklinikum Essen AöR, Essen, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Hiriart', 'Affiliation': 'CHU de Bordeaux, Pessac, France.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'Eli Lilly, New York, NY, USA.'}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Kindai University, Osaka-Sayama, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30937-9']
799,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
800,30676124,Reducing ceiling effects in the Working Alliance Inventory-Rehabilitation Dutch Version.,"Purpose:  To reduce ceiling effects on domain scores (Task, Goal, and Bond) of the Working Alliance Inventory (WAI)-Rehabilitation Dutch Version by changing response scales and using Visual Analogue Scales (VASs). Methods:  Clients, who had at least three treatment sessions prior, randomly received one of the three versions of the WAI-Rehabilitation Dutch Version, using items with a balanced Likert scale, Positive-Packed Likert scale or VAS. Primary outcome was percentage of ceiling effects in total- and domain scores, secondary outcomes were construct validity and internal consistency of the three versions. Results:  One hundred and seventy-six clients randomly received a set of questionnaires (one of the three versions of the WAI-Rehabilitation Dutch Version, Session Rating Scale (SRS) and Helping Alliance Questionnaire (HAQ)-II); 152 participants (mean age 51.5 ± 16.3, 106 women) returned the questionnaires. No ceiling effects were present in the total scores of all versions. Significantly fewer ceiling effects were found in the VAS-Version (Goal: 8.0%, Bond: 7.7%) compared to the original (Goal: 18.0%, Bond: 29.8%) and Positive-Packed Version (Goal: 27.1%, Bond: 29.8%). Spearman's correlations between VAS-Version, SRS and HAQ-II ranged 0.747-0.845. Conclusions:  Visual Analogue Scales effectively reduced ceiling effects on domain scores of the WAI-Rehabilitation Dutch Version, while maintaining validity.Implications for RehabilitationVisual Analogue Scales effectively reduced ceiling effects on domain scores of the Working Alliance Inventory-Rehabilitation Dutch Version, while maintaining construct validity.The Working Alliance Inventory version with Visual Analogue Scales can be used in rehabilitation.",2020,"Implications for Rehabilitation Visual Analogue Scales effectively reduced ceiling effects on domain scores of the Working Alliance Inventory-Rehabilitation Dutch Version, while maintaining construct validity.","['Clients, who had at least three treatment sessions prior', '152 participants (mean age 51.5\u2009±\u200916.3, 106 women) returned the questionnaires', 'One hundred and seventy-six clients']",[],"['percentage of ceiling effects in total- and domain scores, secondary outcomes were construct validity and internal consistency of the three versions', 'ceiling effects', 'domain scores (Task, Goal, and Bond) of the Working Alliance Inventory (WAI)-Rehabilitation Dutch Version by changing response scales and using Visual Analogue Scales (VASs', 'WAI-Rehabilitation Dutch Version, Session Rating Scale (SRS) and Helping Alliance Questionnaire (HAQ)-II']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]",[],"[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4273502', 'cui_str': 'SRS (Session Rating Scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",176.0,0.0535128,"Implications for Rehabilitation Visual Analogue Scales effectively reduced ceiling effects on domain scores of the Working Alliance Inventory-Rehabilitation Dutch Version, while maintaining construct validity.","[{'ForeName': 'Davy', 'Initials': 'D', 'LastName': 'Paap', 'Affiliation': 'Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Schepers', 'Affiliation': 'Department of Clinical Health Science, Faculty of Medicine, University of Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Pieter U', 'Initials': 'PU', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1563833']
801,31856903,Efficacy of Behavioral Experiments in Cognitive Therapy for Social Anxiety Disorder: Study protocol for a randomized controlled trial.,"BACKGROUND


While the efficacy of cognitive therapy (CT) has been well established for social anxiety disorder (SAD) in several randomized controlled trials, there are still large differences between trials with respect to effect sizes. The present study investigates the question of whether enhanced training and the use of behavioral experiments (BEs) increases the efficacy of traditional CT, based on verbal methods of cognitive restructuring.
METHODS/DESIGN


A mixed within/between conditions design will be applied, with therapists and patients being randomly allocated to one of two conditions: (1) training of CT plus BEs, (2) training of CT ""as usual"". Sixty patients with the primary diagnosis of SAD will be recruited and treated in the outpatient clinic of the Department of Psychology, University of Frankfurt. To ensure adherence to therapist protocols, all therapists will be trained and supervised by the project coordinators. In addition, videotaped treatment sessions will be independently evaluated to guarantee both adherence to protocols and the quality of the intervention. Treatment effects will be assessed by independent SAD symptom ratings using the Liebowitz Social Anxiety Scale as the primary outcome measure and self-report measures as secondary outcome measures.
DISCUSSION


The present cognitive behavioral therapy (CBT) trial will be the first to clarify the contribution of BEs to the efficacy of CT in a randomized controlled design. Study results are relevant to clinical training and implementation of evidence-based treatments.
TRIAL REGISTRATION


German Clinical Trials Register International Clinical Trials Registry Platform (ICTRP) identifier: DRKS00014349. Trial status: recruiting.",2019,"Treatment effects will be assessed by independent SAD symptom ratings using the Liebowitz Social Anxiety Scale as the primary outcome measure and self-report measures as secondary outcome measures.
","['Social Anxiety Disorder', 'Sixty patients with the primary diagnosis of SAD will be recruited and treated in the outpatient clinic of the Department of Psychology, University of Frankfurt']","['cognitive behavioral therapy (CBT', 'enhanced training', 'cognitive therapy (CT', 'Behavioral Experiments', 'training of CT plus BEs, (2) training of CT ""as usual']",['SAD symptom ratings using the Liebowitz Social Anxiety Scale'],"[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0053353', 'cui_str': 'N,N-bis(2-hydroxyethyl)aminoethanesulfonic acid'}]","[{'cui': 'C0429688', 'cui_str': 'Symptom ratings (staging scale)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0222045'}]",60.0,0.0616477,"Treatment effects will be assessed by independent SAD symptom ratings using the Liebowitz Social Anxiety Scale as the primary outcome measure and self-report measures as secondary outcome measures.
","[{'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Clément', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Goethe University of Frankfurt, Varrentrappstraße 40-42, 60486, Frankfurt, Germany.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Goethe University of Frankfurt, Varrentrappstraße 40-42, 60486, Frankfurt, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stangier', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Goethe University of Frankfurt, Varrentrappstraße 40-42, 60486, Frankfurt, Germany. stangier@psych.uni-frankfurt.de.'}]",Trials,['10.1186/s13063-019-3905-3']
802,30773564,[C5-6 nerve root block technique for postoperative analgesia of shoulder arthroscope: a randomized controlled trial].,"OBJECTIVE


To compare the effects of ultrasound-guided interscalene brachial plexus block and C5-6 nerve root block for analgesia after shoulder arthroscopy.
METHODS


In the study, 40 patients of ASA I-II were selected for elective general anesthesia to repair the shoulder ligament rupture in Peking University Third Hospital, who were randomly divided into two groups, respectively for the intermuscular brachial plexus block group (group I) and C5-6 nerve root block group (group C), n=20. The forty patients underwent ultrasound-guided brachial plexus block or C5-6 nerve root block before general anesthesia. Group I: 0.2% ropivacaine 10 mL was injected into brachial plexus intermuscular approach; Group C: 0.2% ropivacaine 10 mL was injected around the nerve roots of C5 and C6, and the ultrasound images showed that the liquid wrapped nerve roots. The time of sensory and motor block after puncture, operation time, the time of postoperative analgesia, numerical rating scale (NRS) scores at 1, 6, 12, and 24 h postoperatively and the finger movements were recorded. The adverse drug reactions and the patient satisfaction were recorded. The primary end point was the study of shoulder rest and movement pain in the patients with postoperative nerve blockage; the secondary end point was the patient's limb movements and thepatient satisfaction.
RESULTS


The duration of analgesia was (571.50±70.11) min in group I and (615.60±112.15) min in group C, and there was no difference between the two groups (P>0.05). The static and dynamic NRS scores at 1, 6, and 12 h in group C were lower than those in group I (P<0.05). There was no difference in static and dynamic NRS scores between the two groups during 24 hours (P>0.05). There was a significant difference in grade of muscle strength between group C [5(4,5)] and group I [4(2,4)] in the patients with nerve block hind limb (P<0.01), and there were significant differences between the two groups' sensation in the radial nerve group C [1(0,2)] and group I [2(1,2)], the median nerve group C [0(0,2)] and group I [2(1,2)], and the ulnar nerves group C [0(0,1)] and group I [1(1,2)] (P<0.01). There was no statistical difference between the two groups in the sencation of the shoulder, group C 2(1,2) and group I 2(1,2) , P>0.05. Compared with group I 8(6,9), group C 9(8,10) was a significant difference in satisfaction (P<0.01).
CONCLUSION


Interscalene brachial plexus block and C5-6 nerve root block could satisfy the needs of analgesia after shoulder arthroscopy, but C5-6 nerve root blockage does not limit the limb activity, the numbness is less, and the patient's satisfaction is higher.",2019,There was no difference in static and dynamic NRS scores between the two groups during 24 hours (P>0.05).,"['postoperative analgesia of shoulder arthroscope', 'forty patients underwent', '40 patients of ASA I-II were selected for elective general anesthesia to repair the shoulder ligament rupture in Peking University Third Hospital']","['ropivacaine', 'ultrasound-guided brachial plexus block or C5-6 nerve root block before general anesthesia', 'ultrasound-guided interscalene brachial plexus block and C5-6 nerve root block', 'C5-6 nerve root block technique', 'intermuscular brachial plexus block group (group I) and C5-6 nerve root block group']","['shoulder rest and movement pain', 'duration of analgesia', 'time of sensory and motor block after puncture, operation time, the time of postoperative analgesia, numerical rating scale (NRS) scores', 'grade of muscle strength', 'adverse drug reactions and the patient satisfaction', 'static and dynamic NRS scores', ""patient's limb movements and thepatient satisfaction""]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0179144', 'cui_str': 'Arthroscopes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0435118', 'cui_str': 'Rupture of shoulder ligament (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",40.0,0.0538172,There was no difference in static and dynamic NRS scores between the two groups during 24 hours (P>0.05).,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking University Third Hospital, Beijing 100191, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,['10.19723/j.issn.1671-167X.2019.01.030']
803,30235221,Successful adherence and retention to daily monitoring of physical activity: Lessons learned.,"Research utilizing repeated-measures such as daily assessments with self-report and/or objective measures [e.g., physical activity (PA) monitors] are important in understanding health behaviors and informing practice and policy. However, studies that utilize daily assessment often encounter issues with attrition and non-compliance. The current research yielded high levels of retention and adherence with both self-report and objective daily measures. The purpose of this paper is to highlight and discuss strategies utilized in maximizing retention, minimizing missing data, and some lessons learned from the research experience. Fifty community participants took part in a 4-week study utilizing both daily self-report questionnaires and daily use of PA monitors (Fitbit One™). This study focused on typical daily PA and was not an intervention study (e.g., participants were not randomized nor asked to change their PA behavior). Participants completed the study in two waves (wave 1 n = 10, wave 2 n = 40). The research team utilized several retention strategies including automating the data collection process, a prorated incentive structure, having a dedicated and responsive study staff, and utilizing the 2-wave process to optimize data collection during the 2nd wave. The study had 100% retention and generally positive anonymous feedback post-study. Overall, participants completed the vast majority of daily surveys (97%) and wore their Fitbits (for at least part of the day) on almost all days (99.57%) of the study, although there were individual differences. The strategies discussed and lessons learned may be useful to other researchers using daily measurements for whom adherence and retention are important issues. Future research employing these strategies in different populations, with different measurements, and for longer durations is warranted to determine generalizability.",2018,The study had 100% retention and generally positive anonymous feedback post-study.,"['Participants completed the study in two waves (wave 1 n = 10, wave 2 n = 40', 'Fifty community participants took part in a 4-week study utilizing both']",['daily self-report questionnaires and daily use of PA monitors (Fitbit One™'],[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0966141', 'cui_str': '2-N-(APPDHP)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",[],50.0,0.0275573,The study had 100% retention and generally positive anonymous feedback post-study.,"[{'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychology, Idaho State University, Pocatello, Idaho, United States of America.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Tupy', 'Affiliation': 'Department of Psychology, Idaho State University, Pocatello, Idaho, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Robertson', 'Affiliation': 'Department of Psychology, Idaho State University, Pocatello, Idaho, United States of America.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon, United State of America.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Correll', 'Affiliation': 'Department of Psychology, University of Colorado Colorado Springs, Colorado Springs, Colorado, United States of America.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Tivis', 'Affiliation': 'Idaho Center for Health Research, Idaho State University, Meridian, Idaho, United States of America.'}, {'ForeName': 'Claudio R', 'Initials': 'CR', 'LastName': 'Nigg', 'Affiliation': ""Office of Public Health Studies, University of Hawai'i at Manoa, Honolulu, Hawaii, United States of America.""}]",PloS one,['10.1371/journal.pone.0199838']
804,30758247,Smartphone Application Versus Pedometer to Promote Physical Activity in Prostate Cancer Patients.,"Background:  Recently, the application of smartphone in medical field has received great attention.   Introduction:  The objective of this study was to compare the effectiveness of smartphone-based and conventional pedometer-based exercise monitoring systems in promoting home exercise among prostate cancer patients.   Methods:  Prostate cancer patients who have undergone surgery or androgen deprivation therapy were recruited. All participants were provided with physical activity goals based on their activities and were advised to achieve these goals during their home exercise period. The intervention group was instructed to use smartphone application to record their activities; they also received weekly remote consultations based on the activity record from the application, without visiting a clinic. The control group was instructed to keep a written record of their daily activities based on pedometer readings; these records were checked by clinicians during follow-up visits. The uptake, adherence, and completion rates of two groups were compared by intention-to-treat analysis. Changes in physical function during the exercise period were analyzed.   Results:   In total, 100 patients were recruited (smartphone: 5 and pedometer: 50). No significant differences were detected between groups in rates of uptake (80.0% vs. 88.0%,  p  = 0.28), adherence (92.5% vs. 79.5%,  p  = 0.12), or completion (76.0% vs. 86.0%,  p  = 0.20). Physical functions were significantly improved in both groups.   Conclusions:  The smartphone-based exercise monitoring system and the pedometer yielded comparable results in promoting physical activity, as assessed by rates of uptake, adherence, and completion. Exercise monitoring was effective in improving physical functions, in both methods.",2019,"No significant differences were detected between groups in rates of uptake (80.0% vs. 88.0%, p = 0.28), adherence (92.5% vs. 79.5%, p = 0.12), or completion (76.0% vs. 86.0%, p = 0.20).","['Prostate cancer patients who have undergone surgery or androgen deprivation therapy were recruited', 'Prostate Cancer Patients', '100 patients were recruited (smartphone: 5 and pedometer: 50', 'prostate cancer patients']","['Smartphone Application Versus Pedometer to Promote Physical Activity', 'smartphone application to record their activities; they also received weekly remote consultations based on the activity record from the application, without visiting a clinic', 'Exercise monitoring', 'smartphone-based and conventional pedometer-based exercise monitoring systems']","['physical function', 'rates of uptake', 'physical functions', 'uptake, adherence, and completion rates', 'Physical functions', 'adherence', 'rates of uptake, adherence, and completion']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0282674', 'cui_str': 'Remote Consultation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",100.0,0.0408268,"No significant differences were detected between groups in rates of uptake (80.0% vs. 88.0%, p = 0.28), adherence (92.5% vs. 79.5%, p = 0.12), or completion (76.0% vs. 86.0%, p = 0.20).","[{'ForeName': 'Byung Joo', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': ""Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Ji Youl', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': ""Department of Rehabilitation Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jong In', 'Initials': 'JI', 'LastName': 'Lee', 'Affiliation': ""Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0233']
805,30526031,Ureteral Wall Injury with Ureteral Access Sheaths: A Randomized Prospective Trial.,"Objective:  To compare two commercially available ureteral access sheaths in their ability to access the renal collecting system and assess ureteral wall trauma using a prospective, randomized trial.  Patients and Methods:  Ninety-five patients undergoing ureteroscopy for renal stones were randomized to Cook Flexor™ or Boston Scientific Navigator HD™ 12/14F sheaths. If the initial sheath failed to advance, an alternate sheath was attempted. The primary outcome was the difference in these access sheaths to obtain access to the upper collecting system and the postoperative ureteral injury using standardized five-point classification system.  Results:  The overall success rate for sheath placement was 87.4% and did not differ for sheath groups. The Navigator HD was successful in 43% of the Flexor failures and was subjectively rated as easier to place ( p  = 0.018). Male gender, large stone burden, longer time of sheath insertion, and a more difficult subjective rating for sheath placement were associated with high-grade (grade 2 or 3) ureteral injury. Limitations include a small sample size and absence of long-term follow-up.  Conclusion:  Sheaths had equal success of placement and there was no significant difference in ureteral wall injury between the two sheaths. Subjectively difficult sheath placement and longer time of placement were associated with high-grade injury, suggesting that surgeons should carry a low threshold for switching to a smaller sheath when resistance is felt or if placement time is long. Clinical Trial number: Nct03349099.",2020,The Navigator HD was successful in 43% of the Flexor failures and was subjectively rated as easier to place ( p  = 0.018).,"['Ureteral Wall Injury with Ureteral Access Sheaths', 'Ninety-five patients undergoing ureteroscopy for renal stones']",['Cook Flexor™ or Boston Scientific Navigator'],"['ureteral wall injury', 'overall success rate for sheath placement', 'access sheaths to obtain access to the upper collecting system and the postoperative ureteral injury using standardized five-point classification system']","[{'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}]","[{'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}]","[{'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0238493', 'cui_str': 'Injury of ureter (disorder)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]",95.0,0.301689,The Navigator HD was successful in 43% of the Flexor failures and was subjectively rated as easier to place ( p  = 0.018).,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Loftus', 'Affiliation': 'Department of Urology, University of Washington Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Vishnuvardhan', 'Initials': 'V', 'LastName': 'Ganesan', 'Affiliation': 'Cleveland Clinic, Glickman Urological and Kidney Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': 'Department of Urology, Hôpital Tenon, Université Pierre et Marie Curie Paris 6, Paris, France.'}, {'ForeName': 'Jesse D', 'Initials': 'JD', 'LastName': 'Schold', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Noble', 'Affiliation': 'Cleveland Clinic, Glickman Urological and Kidney Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Sivalingam', 'Affiliation': 'Cleveland Clinic, Glickman Urological and Kidney Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Muruve', 'Affiliation': 'Department of Urology, Cleveland Clinic Florida, Weston, Florida, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Monga', 'Affiliation': 'Cleveland Clinic, Glickman Urological and Kidney Institute, Cleveland, Ohio, USA.'}]",Journal of endourology,['10.1089/end.2018.0603']
806,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS


In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
807,32407947,"Intralymphatic immunotherapy for mountain cedar pollinosis: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Allergen immunotherapy can provide long-term benefits, including symptomatic relief and reduced disease progression, but it requires a lengthy regimen that presents barriers to patient adherence. Thus, there is a need for improved approaches to immunotherapy. Recently, several clinical trials have reported successful results from intralymphatic immunotherapy.
OBJECTIVE


To evaluate the efficacy, safety, and tolerability of intralymphatic immunotherapy for allergies caused by mountain cedar pollen in a proof-of-concept study.
METHODS


A total of 21 patients with allergic rhinoconjunctivitis because of mountain cedar pollen were randomized to receive 3 monthly intralymphatic injections of allergenic extract or placebo before the 2018-2019 mountain cedar pollen season. Safety was monitored during treatment to the end of the pollen season using structured and spontaneous reports. Clinical efficacy information was collected using a daily electronic diary of symptoms and allergy medication. Allergen-specific serum immunoglobulin E was assessed before treatment and at the end of the study.
RESULTS


There were no serious adverse events or systemic reactions in either group. A total of 4 patients experienced mild injection-site reactions. Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (P < .001), and the active treatment group had lower average total combined scores on 20 of 27 days during the peak pollen season (P < .05). There was no significant difference among groups in changes to mean mountain cedar-specific serum immunoglobulin E levels.
CONCLUSION


In this proof-of-concept trial, intralymphatic immunotherapy was well tolerated and improved the symptoms and medication use associated with allergic rhinoconjunctivitis caused by mountain cedar pollen.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov under the registration number NCT03682965 before the enrollment of the first subject.",2020,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"['mountain cedar pollinosis', 'prior to the 2018-2019 mountain cedar pollen season', 'Twenty-one patients with allergic rhinoconjunctivitis due to mountain cedar pollen']","['allergenic extract or placebo', 'intralymphatic immunotherapy', 'Intralymphatic immunotherapy', 'placebo']","['Safety', 'allergy symptoms and medication use relative', 'serious adverse events or systemic reactions', 'efficacy, safety and tolerability', 'mild injection-site reactions', 'mean mountain cedar-specific serum IgE levels', 'average total combined scores']","[{'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0440386', 'cui_str': 'Mountain cedar pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0440016', 'cui_str': 'Allergenic extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",21.0,0.239599,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Thompson', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Silvers', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Mark Adam', 'Initials': 'MA', 'LastName': 'Shapiro', 'Affiliation': 'Pharma Initiatives Consulting, Chapel Hill, North Carolina. Electronic address: mshapiro@pharmainitiatives.com.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.030']
808,30887927,"Dietary Adherence, Self-Efficacy, and Health Behavior Change of WASHOKU-Modified DASH Diet: A Sub-analysis of the DASH-JUMP Study.","BACKGROUND


We previously reported the nutritional characteristics and effects of the DASH-JUMP diet, which is a WASHOKU-modified DASH diet, in Japanese participants with untreated high-normal blood pressure or stage 1 hypertension. The dietary adherence of the DASH diet in Japanese participants has never been evaluated before.
OBJECTIVE


We aimed to assess the relationships between dietary adherence, self-efficacy, and health behavior change among study participants who received the DASH-JUMP diet by home delivery.
METHODS


Participants were treated with the DASH-JUMP diet for 2 months and consumed their usual diets for the next 4 months. We conducted surveys using the stage of behavior change model questionnaire and the modified perceived health competence scale Japanese version questionnaire at baseline and 1, 2, 3, and 6 months to assess dietary adherence.
RESULTS


Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years) returned completed questionnaires, which we analyzed. Health behavior change was motivated by previous behavioral changes and improved biomarkers. The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy. The experience of the DASH-JUMP study for participants included three processes to improve lifestyle habits: Phase 1, reflecting on previous lifestyle habits; Phase 2, learning through new experiences and the acquisition of knowledge; and Phase 3, desiring to maintain their own health.
CONCLUSION


It indicated that the DASH-JUMP diet significantly increased self-efficacy and promoted health behavior change.",2020,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"['Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years', 'Japanese participants with untreated high-normal blood pressure or stage 1 hypertension', 'Japanese participants', 'Participants were treated with the', 'study participants who received the DASH-JUMP diet by home delivery']","['DASH-JUMP diet', 'modified DASH Diet', 'DASH diet']","['health behavior change and previous self-efficacy', 'improvement and maintenance of self-efficacy', 'health competence scale Japanese version questionnaire', 'Dietary Adherence, Self-Efficacy, and Health Behavior Change', 'self-efficacy and promoted health behavior change', 'dietary adherence, self-efficacy, and health behavior change']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}]","[{'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",43.0,0.019028,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Inagaki', 'Affiliation': 'Faculty of Nursing Science, Yamanashi Prefectural University, Kouhu, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Umemoto', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Kajiya', 'Affiliation': 'Department of Food Science and Biotechnology, Faculty of Agriculture, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kishi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Mitarai', 'Affiliation': 'Central Research Institute, Maruha Nichiro Corporation, Tsukuba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Sei', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}]",Current hypertension reviews,['10.2174/1573402115666190318125006']
809,32408253,Effect of amino acids on IGF1 gene expression in human myotubes and skeletal muscle.,"OBJECTIVE


Insulin-like growth factor I (IGF1) is an important regulator of collagen and extracellular matrix protein expression. We aimed to evaluate the effect of amino acids (AAs) on expression of IGF1 and IGF1-dependent genes in human myotubes and skeletal muscle and supposed that AAs administration increases IGF1 levels in blood and expression of IGF1 and IGF1-dependent genes in trained skeletal muscle, thereby reducing training-induced muscle damage.
DESIGN


Human myotubes were incubated with Arg and Leu for 24 h. Then, the effects of long-term branched chain AAs administration (10 weeks, 0.1 g/kg body mass/day) to volunteers (six subjects per AAs and placebo groups) performing large training volumes regularly (cross country skiers, training twice a day) were examined.
RESULTS


Incubating the myotubes with AAs increases expression of IGF1 mRNA isoforms and IGF1 secretion by 2-3 times. In athletes, long-term AAs administration increased basal blood levels of IGF1 (~50%) and expression of IGF1Ea mRNA slightly in skeletal muscle. There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration. However, expression of these genes in the combined group (placebo + AAs; n = 12) significantly correlated with the expression of IGF1Ea mRNA in muscle and did not correlate with IGF1 levels in the blood.
CONCLUSIONS


AAs administration increases IGF1 expression in vitro and in vivo. To obtain more pronounced changes in expression of IGF1 and IGF1-dependent genes in skeletal muscle, it may be necessary to increase the dose and/or duration of AAs administration.",2020,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","['human myotubes and skeletal muscle', 'Human myotubes were incubated with Arg and Leu for 24\xa0h']","['Insulin-like growth factor', 'amino acids', 'amino acids (AAs']","['IGF1 gene expression', 'IGF1 expression', 'basal blood levels of IGF1', 'expression of IGF1 mRNA isoforms and IGF1 secretion', 'expression of IGF1Ea mRNA', 'expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle', 'IGF1 levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}]","[{'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0972255', 'cui_str': 'type I collagen alpha 1'}, {'cui': 'C0024375', 'cui_str': 'Protein-lysine 6-oxidase'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.0302591,"There is no marked increase in expression of COL1A1, COL3A1, COL5A1, and LOX genes in skeletal muscle after AAs administration.","[{'ForeName': 'Egor M', 'Initials': 'EM', 'LastName': 'Lednev', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation. Electronic address: ledhauz@gmail.com.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Kravchenko', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Vladimir A', 'Initials': 'VA', 'LastName': 'Furalyov', 'Affiliation': 'Federal Research Centre «Fundamentals of Biotechnology» of the Russian Academy of Sciences, 33 build 2, Leninsky prospect, Moscow 119071, Russian Federation.'}, {'ForeName': 'Evgeny A', 'Initials': 'EA', 'LastName': 'Lysenko', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Iulia S', 'Initials': 'IS', 'LastName': 'Lemesheva', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Alexandr A', 'Initials': 'AA', 'LastName': 'Grushin', 'Affiliation': 'Russian Olympic Committee, Luzhnetskaya Embankment 8, Russia, Moscow 119991, Russian Federation.'}, {'ForeName': 'Vadim E', 'Initials': 'VE', 'LastName': 'Dubrov', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Fundamental Medicine, 27 build. 1, Lomonosovsky Prospekt, Moscow 119991, Russian Federation.'}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Vinogradova', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}, {'ForeName': 'Daniil V', 'Initials': 'DV', 'LastName': 'Popov', 'Affiliation': 'Institute of Biomedical Problems of the RAS, 76A Khoroshevskoye Shosse, Moscow 123007, Russian Federation.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101323']
810,30129666,Acute hydrocortisone administration reduces cardiovagal baroreflex sensitivity and heart rate variability in young men.,"KEY POINTS


A surge in cortisol during acute physiological and pathophysiological stress may precipitate ventricular arrhythmia and myocardial infarction. Reduced cardiovagal baroreflex sensitivity and heart rate variability are observed during acute stress and are associated with an increased risk of acute cardiac events. In the present study, healthy young men received either a single iv bolus of saline (placebo) or hydrocortisone, 1 week apart, in accordance with a randomized, placebo-controlled, cross-over study design. Hydrocortisone acutely increased heart rate and blood pressure and reduced cardiovagal baroreflex sensitivity and heart rate variability in young men. These findings suggest that, by reducing cardiovagal baroreflex sensitivity and heart rate variability, acute surges in cortisol facilitate a pro-arrhythmic milieu and provide an important mechanistic link between stress and acute cardiac events ABSTRACT: Surges in cortisol concentration during acute stress may increase cardiovascular risk. To better understand the interactions between cortisol and the autonomic nervous system, we determined the acute effects of hydrocortisone administration on cardiovagal baroreflex sensitivity (BRS), heart rate variability (HRV) and cardiovascular reactivity. In a randomized, placebo-controlled, single-blinded cross-over study, 10 healthy males received either a single iv bolus of saline (placebo) or 200 mg of hydrocortisone, 1 week apart. Heart rate (HR), blood pressure (BP) and limb blood flow were monitored 3 h later, at rest and during the sequential infusion of sodium nitroprusside and phenylephrine (modified Oxford Technique), a cold pressor test and a mental arithmetic stress task. HRV was assessed using the square root of the mean of the sum of the squares of differences between successive R-R intervals (rMSSD). Hydrocortisone markedly increased serum cortisol 3 h following infusion and also compared to placebo. In addition, hydrocortisone elevated resting HR (+7 ± 4 beats min -1  ; P < 0.001) and systolic BP (+5 ± 5 mmHg; P = 0.008); lowered cardiovagal BRS [geometric mean (95% confidence interval) 15.6 (11.1-22.1) ms/mmHg vs. 26.2 (17.4--39.5) ms/mmHg, P = 0.011] and HRV (rMSSD 59 ± 29 ms vs. 84 ± 38 ms, P = 0.004) and increased leg vasoconstrictor responses to cold pressor test (Δ leg vascular conductance -45 ± 20% vs. -23 ± 26%; P = 0.023). In young men, an acute cortisol surge is accompanied by increases in HR and BP, as well as reductions in cardiovagal BRS and HRV, potentially providing a pro-arrhythmic milieu that may precipitate ventricular arrhythmia or myocardial infarction and increase cardiovascular risk.",2018,Hydrocortisone acutely increased heart rate and blood pressure and reduced cardiovagal baroreflex sensitivity and heart rate variability in young men.,"['young men', 'healthy young men', '10 healthy males']","['Acute hydrocortisone', 'placebo', 'single iv bolus of saline (placebo', 'single iv bolus of saline (placebo) or hydrocortisone', 'sodium nitroprusside and phenylephrine (modified Oxford Technique), a cold pressor test and a mental arithmetic stress task', 'hydrocortisone', 'Hydrocortisone']","['serum cortisol', 'systolic BP', 'cardiovagal BRS [geometric mean', 'cardiovagal baroreflex sensitivity (BRS), heart rate variability (HRV) and cardiovascular reactivity', 'cardiovagal baroreflex sensitivity and heart rate variability, acute surges', 'cardiovagal baroreflex sensitivity and heart rate variability', 'leg vasoconstrictor responses to cold pressor test', 'heart rate and blood pressure and reduced cardiovagal baroreflex sensitivity and heart rate variability', 'acute cortisol surge', 'HR and BP', 'HRV', 'hydrocortisone elevated resting HR', 'Heart rate (HR), blood pressure (BP) and limb blood flow', 'cardiovascular risk']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",10.0,0.337049,Hydrocortisone acutely increased heart rate and blood pressure and reduced cardiovagal baroreflex sensitivity and heart rate variability in young men.,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Adlan', 'Affiliation': 'College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Jet J C S', 'Initials': 'JJCS', 'LastName': 'Veldhuijzen van Zanten', 'Affiliation': 'College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, UK.'}, {'ForeName': 'Julian F R', 'Initials': 'JFR', 'LastName': 'Paton', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Kitas', 'Affiliation': 'Department of Rheumatology, Dudley Group NHS Foundation Trust, Russells Hall Hospital, Dudley, West Midlands, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.'}]",The Journal of physiology,['10.1113/JP276644']
811,30481272,"Immunogenicity and Viral Shedding of Russian-Backbone, Seasonal, Trivalent, Live, Attenuated Influenza Vaccine in a Phase II, Randomized, Placebo-Controlled Trial Among Preschool-Aged Children in Urban Bangladesh.","BACKGROUND


We evaluated a Russian-backbone, live, attenuated influenza vaccine (LAIV) for immunogenicity and viral shedding in a randomized, placebo-controlled trial among Bangladeshi children.
METHODS


Healthy children received a single, intranasal dose of LAIV containing the 2011-2012 recommended formulation or placebo. Nasopharyngeal wash (NPW) specimens were collected on days 0, 2, 4, and 7. Reverse transcription polymerase chain reactions and sequencing identified the influenza virus (vaccine or wild-type). On days 0 and 21, blood specimens were collected to assess immunogenicity using hemagglutination inhibition, microneutralization, and immunoglobulin A (IgA) and G enzyme-linked immunosorbent assays (ELISAs); NPW specimens were also collected to assess mucosal immunogenicity using kinetic IgA ELISA.
RESULTS


We enrolled 300 children aged 24 through 59 months in the immunogenicity and viral shedding analyses. Among children receiving LAIV, 45% and 67% shed A/H3N2 and B vaccine strains, respectively. No child shed A/H1N1 vaccine strain. There were significantly higher day 21 geometric mean titers (GMTs) for the LAIV, as compared to the placebo groups, in all immunoassays for A/H3N2 and B (log10 titer P < .0001; GMT Ratio >2.0). Among immunoassays for A/H1N1, only the mucosal IgA GMT was significantly higher than placebo at day 21 (log10 titer P = .0465).
CONCLUSIONS


Children vaccinated with LAIV had serum and mucosal antibody responses to A/H3N2 and B, but only a mucosal IgA response to A/H1N1. Many children shed A/H3N2 and B vaccine strains, but none shed A/H1N1. More research is needed to determine the reason for decreased LAIV A/H1N1 immunogenicity and virus shedding.
CLINICAL TRIALS REGISTRATION


NCT01625689.",2019,"There were significantly higher day 21 geometric mean titers (GMTs) for the LAIV as compared to the placebo groups in all immunoassays for A/H3N2 and B (Log10 titer p<0.0001, GMT Ratio >2.0).","['pre-school aged children in urban Bangladesh', 'Three-hundred children aged 24-59 months', 'Bangladeshi children']","['RTPCR and sequencing identified influenza virus (vaccine or wild-type', 'placebo', 'Russian-backbone seasonal trivalent, live-attenuated influenza vaccine', 'Russian-backbone, live-attenuated influenza vaccine (LAIV', 'H3N2']","['higher day 21 geometric mean titers (GMTs', 'serum and mucosal antibody responses', 'mucosal IgA GMT']","[{'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}]","[{'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",300.0,0.265578,"There were significantly higher day 21 geometric mean titers (GMTs) for the LAIV as compared to the placebo groups in all immunoassays for A/H3N2 and B (Log10 titer p<0.0001, GMT Ratio >2.0).","[{'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'Pharmaceutical Product Development, San Diego, California.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Mohammed Z', 'Initials': 'MZ', 'LastName': 'Rahman', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Rudenko', 'Affiliation': 'Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Wright', 'Affiliation': 'Dartmouth College, Hanover, New Hampshire.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Katz', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Corporation, Rockville.'}, {'ForeName': 'Mustafizur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrheal Disease Research, Bangladesh, Dhaka.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Isakova-Sivak', 'Affiliation': 'Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia.'}, {'ForeName': 'Natalia A', 'Initials': 'NA', 'LastName': 'Ilyushina', 'Affiliation': 'Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Matyushenko', 'Affiliation': 'Department of Virology, Institute of Experimental Medicine, St Petersburg, Russia.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Fry', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Lindstrom', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Bresee', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'W Abdullah', 'Initials': 'WA', 'LastName': 'Brooks', 'Affiliation': 'International Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1003']
812,31589776,Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial.,"Implant loosening is the most common indication for revision surgery after total hip arthroplasty (THA). Although bone resorption around the implants plays a pivotal role in the pathophysiology of loosening, it is unknown whether potent early inhibition of osteoclasts could mitigate this process and thus reduce the need for revision surgery. We performed a randomized, double-blind, placebo-controlled phase 2 trial in 64 patients aged 35 to 65 years with unilateral osteoarthritis of the hip. They underwent surgery with an uncemented THA and were randomized to either two subcutaneous doses of denosumab (n = 32) or placebo (n = 32) given 1 to 3 days and 6 months after surgery. Patients were followed for 24 months. Primary outcome was periprosthetic bone mineral density (BMD) of the hip at 12 months as measured by dual-energy X-ray absorptiometry (DXA). In addition, [ 18  F] sodium fluoride positron emission tomography/CT (F-PET) was performed in half of the patients for analysis of periprosthetic standardized uptake value (SUV). Analyses were made according to intention-to-treat principles. The trial was registered at ClinicalTrials.gov 2011-001481-18, NCT01630941. Denosumab potently inhibited early periprosthetic bone loss. After 12 months, BMD in the denosumab group was 32% (95% confidence interval [CI] 22-44) higher in Gruen zone 7 and 11% (95% CI 8-15) higher in zones 1 to 7. After 24 months, the difference in BMD between groups had decreased to 15% (95% CI 4-27) in zone 7 and 4% (95% CI 0-8) in zones 1 to 7. In both groups, SUV increased after surgery, but the increase was less pronounced in the denosumab group. Biochemical markers of bone metabolism decreased in the denosumab group in the first 12 months, but a rebound effect with marker concentrations above baseline was observed after 24 months. Denosumab potently prevents early periprosthetic bone loss after uncemented THA; however, the effect diminishes after discontinuation of treatment. Further research is needed to determine whether this bone loss will prove to be of clinical importance and, if so, whether the positive effect observed in this study could be preserved by either prolonged treatment with denosumab or additional antiresorptive treatment. © 2019 American Society for Bone and Mineral Research. © 2019 American Society for Bone and Mineral Research.",2020,"After 24 months, the difference in BMD between groups had decreased to 15% (95% CI 4-27) in zone 7 and 4% (95% CI 0-8) in zones 1-7.","['revision surgery after total hip arthroplasty (THA', '64 patients aged 35-65\u2009years with unilateral osteoarthritis of the hip', 'They underwent surgery with an uncemented THA', 'after Uncemented Total Hip Arthroplasty']","['Placebo', 'Denosumab', 'placebo', ' 18  F] sodium fluoride positron emission tomography/CT (F-PET', 'denosumab']","['early periprosthetic bone loss', 'BMD', 'periprosthetic bone mineral density (BMD) of the hip at 12 months as measured by dual-energy X-ray absorptiometry', 'SUV', 'Biochemical markers of bone metabolism', 'Periprosthetic Bone Loss', 'periprosthetic bone loss']","[{'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1869108', 'cui_str': 'Biochemical markers of bone metabolism'}]",,0.539169,"After 24 months, the difference in BMD between groups had decreased to 15% (95% CI 4-27) in zone 7 and 4% (95% CI 0-8) in zones 1-7.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nyström', 'Affiliation': 'Department of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Demostenis', 'Initials': 'D', 'LastName': 'Kiritopoulos', 'Affiliation': 'Department of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Gösta', 'Initials': 'G', 'LastName': 'Ullmark', 'Affiliation': 'Department of Orthopedics, Gävle Hospital, Gävle, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sörensen', 'Affiliation': 'Department of Surgical Sciences, Section of Nuclear Medicine & PET, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Petrén-Mallmin', 'Affiliation': 'Department of Surgical Sciences, Section of Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Milbrink', 'Affiliation': 'Department of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Nils P', 'Initials': 'NP', 'LastName': 'Hailer', 'Affiliation': 'Department of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Mallmin', 'Affiliation': 'Department of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3883']
813,30648520,The Effect of Methylphenidate on Reed Scaling in Benzodiazepine Poisoning: A Prospective Trial.,"BACKGROUND


Benzodiazepine is one of the most important causes of substance abuse and intoxication throughout the world and Iran.
OBJECTIVE


The aim of our study is to determine the role of stimulants in reversing CNS level in acute Benzodiazepine poisoning patients who were hospitalized at referral poison center.
METHOD


This was a randomized double-blind placebo-controlled trial study on 32 cases with pure acute Benzodiazepine poisoning from March 2016 to February 2017. Diagnosis of pure acute poisoning was based on history, and laboratory confirmation. We gathered the demographics, clinical data, laboratory data, hospitalization and outcome. Participants were randomized into two groups: Methylphenidate Group (MPH) and Placebo Group (PBO).
RESULTS


The randomized sample consisted of 32 participants who were predominately female (83%). The majority of the PBO group and the MPH group reported improvement in their consciousness with a significant difference between the two groups (p = .005). Paired sample t-test analyses on Reed Scale data revealed an increase in the probability of improvement during the trial for the MPH group compared to the PBO group. Furthermore, the HCo3 (bicarbonate) level has a significant p-value with respect to age groups (p = .02). None of our cases required either the ICU facility or intubation.
CONCLUSION


Our study provided the MPH superiority over PBO in reversing CNS symptoms in loss of consciousness in acute BZD poisoned patients. Thus, this trial provides concrete evidence that improvement in consciousness levels (Reed Scale rated) among those patients receiving MPH was associated with a methylphenidate use.",2020,The majority of the PBO group and the MPH group reported improvement in their consciousness with a significant difference between the two groups (p = .005).,"['32 cases with pure acute Benzodiazepine poisoning from March 2016 to February 2017', '32 participants who were predominately female (83', 'acute Benzodiazepine poisoning patients who were hospitalized a referral poison center', 'acute BZD poisoned patients']","['Benzodiazepine', 'Methylphenidate Group (MPH) and Placebo Group (PBO', 'methylphenidate', 'placebo']","['HCo3 (bicarbonate) level', 'consciousness levels']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0412862', 'cui_str': 'Benzodiazepine poisoning'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0032344', 'cui_str': 'poisoning'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",32.0,0.146873,The majority of the PBO group and the MPH group reported improvement in their consciousness with a significant difference between the two groups (p = .005).,"[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Latifi-Pour', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hassanian-Moghaddam', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Helya-Sadat', 'Initials': 'HS', 'LastName': 'Mortazavi', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Shadnia', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Toxicological Research Center and Excellence Center of Clinical Toxicology, Department of Clinical Toxicology, Loghman Hakim Hospital Poison Center, Shahid Beheshti University of Medical Sciences, Kamali Avenue, South Karegar Street, Tehran, Iran.'}]",Current clinical pharmacology,['10.2174/1574884714666190112153157']
814,30591094,[Effect of High-frequency Chest Wall Oscillatory on Lung Function in Patient 
After Single Port Video-assisted Thoracoscopic Surgery Lobectomy].,"BACKGROUND


It has been confirmed that high-frequency chest wall oscillatory (HFCWO) is a new type of auxiliary sputum discharge device. However, up to now, the specific therapeutic effect of HFCWO is still uncertain. This study aimed to compare the changes of the sputum volume before and after the treatment of HFCWO, and to investigate the effect of HFCWO on lung function and arterial blood gas analysis after single port video-assisted thoracoscopic surgery lobectomy (S-VATS).
METHODS


A total of 90 patients with S-VATS lobectomy were collected in the Second Affiliated Hospital of Soochow University from January 2017 to December 2017, which were randomly divided into the experimental group with HFCWO (n=45) and the control group (n=45) with routine clapping, respectively. The sputum volume of the two groups was measured 5 days before operation. Lung function and arterial blood gas analysis was measured before and 7th days after surgery.
RESULTS


The sputum volume was higher in the experimental group than that of the control group after surgery, there was statistically significant difference for the first three days (P<0.05). There was no statistically significant difference between the two groups in forced expiratory volume in one second (FEV₁), forced vital capacity (FVC) and oxygen partial pressure (PaO₂) before surgery (P>0.05); Compared with those before surgery, FEV₁, FVC and PaO₂ decreased in both groups after surgery (P<0.05); However, FEV₁, FVC and PaO₂ in the experimental group were higher than those in the control group (P<0.05); There was no statistically significant difference in preoperative and postoperative partial pressure of carbon dioxide (PaCO₂) between the two groups (P>0.05).
CONCLUSIONS


HFCWO can significantly increase the amount of sputum excretion, improve lung function and alleviate hypoxia status after S-VATS lobectomy. This study provides a promising approach for HFCWO toward hypoxia status after S-VATS lobectomy.
.",2018,"The sputum volume was higher in the experimental group than that of the control group after surgery, there was statistically significant difference for the first three days (P<0.05).","['Patient', '90 patients with S-VATS lobectomy were collected in the Second Affiliated Hospital of Soochow University from January 2017 to December 2017']","['Single Port Video-assisted Thoracoscopic Surgery Lobectomy', 'HFCWO', 'High-frequency Chest Wall Oscillatory', 'single port video-assisted thoracoscopic surgery lobectomy (S-VATS']","['Lung function and arterial blood gas analysis', 'sputum excretion, improve lung function and alleviate hypoxia status', 'Lung Function', 'lung function and arterial blood gas analysis', 'sputum volume', 'FEV₁, FVC and PaO₂', 'forced expiratory volume in one second (FEV₁), forced vital capacity (FVC) and oxygen partial pressure (PaO₂', 'preoperative and postoperative partial pressure of carbon dioxide (PaCO₂']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C4520228', 'cui_str': 'VATS (video-assisted thoracoscopic surgery) lobectomy'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0205076', 'cui_str': 'Chest Wall'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0425514', 'cui_str': 'Sputum volume'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]",90.0,0.0262488,"The sputum volume was higher in the experimental group than that of the control group after surgery, there was statistically significant difference for the first three days (P<0.05).","[{'ForeName': 'Xuejuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiothoracic Surgery, the Second Hospital Affiliated to Soochow University, Suzhou 215004, China.'}, {'ForeName': 'Yuanjun', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiothoracic Surgery, the Second Hospital Affiliated to Soochow University, Suzhou 215004, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiothoracic Surgery, the Second Hospital Affiliated to Soochow University, Suzhou 215004, China.'}, {'ForeName': 'Yongbing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiothoracic Surgery, the Second Hospital Affiliated to Soochow University, Suzhou 215004, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiothoracic Surgery, the Second Hospital Affiliated to Soochow University, Suzhou 215004, China.'}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2018.12.05']
815,30612116,"Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial.","OBJECTIVES


Cyclophosphamide induction regimens are effective for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), but are associated with infections, malignancies and infertility. Mycophenolate mofetil (MMF) has shown high remission rates in small studies of AAV.
METHODS


We conducted a randomised controlled trial to investigate whether MMF was non-inferior to cyclophosphamide for remission induction in AAV. 140 newly diagnosed patients were randomly assigned to MMF or pulsed cyclophosphamide. All patients received the same oral glucocorticoid regimen and were switched to azathioprine following remission. The primary endpoint was remission by 6 months requiring compliance with the tapering glucocorticoid regimen. Patients with an eGFR <15 mL/min were excluded from the study.
RESULTS


At baseline, ANCA subtype, disease activity and organ involvement were similar between groups. Non-inferiority was demonstrated for the primary remission endpoint, which occurred in 47 patients (67%) in the MMF group and 43 patients (61%) in the cyclophosphamide group (risk difference 5.7%, 90% CI -7.5% to 19%). Following remission, more relapses occurred in the MMF group (23 patients, 33%) compared with the cyclophosphamide group (13 patients, 19%) (incidence rate ratio 1.97, 95% CI 0.96 to 4.23, p=0.049). In MPO-ANCA patients, relapses occurred in 12% of the cyclophosphamide group and 15% of the MMF group. In PR3-ANCA patients, relapses occurred in 24% of the cyclophosphamide group and 48% of the MMF group. Serious infections were similar between groups (26% MMF group, 17% cyclophosphamide group) (OR 1.67, 95% CI 0.68 to 4.19, p=0.3).
CONCLUSION


MMF was non-inferior to cyclophosphamide for remission induction in AAV, but resulted in higher relapse rate.
TRIAL REGISTRATION NUMBER


NCT00414128.",2019,"Following remission, more relapses occurred in the MMF group (23 patients, 33%) compared with the cyclophosphamide group (13 patients, 19%) (incidence rate ratio 1.97, 95% CI 0.96 to 4.23, p=0.049).","['ANCA-associated vasculitis', '140 newly diagnosed patients', 'Patients with an eGFR']","['glucocorticoid', 'Mycophenolate mofetil versus cyclophosphamide', 'cyclophosphamide', 'Mycophenolate mofetil (MMF', 'MMF', 'PR3-ANCA', 'azathioprine', 'Cyclophosphamide induction regimens', 'MMF or pulsed cyclophosphamide']","['Serious infections', 'relapses', 'ANCA subtype, disease activity and organ involvement', 'remission by 6 months requiring compliance']","[{'cui': 'C2717865', 'cui_str': 'Pauci-Immune Vasculitis'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",140.0,0.18704,"Following remission, more relapses occurred in the MMF group (23 patients, 33%) compared with the cyclophosphamide group (13 patients, 19%) (incidence rate ratio 1.97, 95% CI 0.96 to 4.23, p=0.049).","[{'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Hiemstra', 'Affiliation': 'School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Ballarin', 'Affiliation': 'Department of Nephrology, Fundació Puigvert, Barcelona, Spain.'}, {'ForeName': 'Daniel Engelbert', 'Initials': 'DE', 'LastName': 'Blockmans', 'Affiliation': 'Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brogan', 'Affiliation': 'Department of Paediatric Rheumatology, University College London Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Cid', 'Affiliation': ""Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona, Institut d'investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dahlsveen', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Janak', 'Initials': 'J', 'LastName': 'de Zoysa', 'Affiliation': 'Renal Service, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Georgína', 'Initials': 'G', 'LastName': 'Espigol-Frigolé', 'Affiliation': ""Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona, Institut d'investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Department of Rheumatology, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Department of Renal Medicine, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Vaglio', 'Affiliation': ""Department of Biomedical, Experimental and Clinical Sciences 'Mario Serio', University of Firenze, Firenze, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Departments of Medicine and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Walsh', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Department of Renal Medicine, Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'Institute of Clinical Sciences, University of Birmingham, Birmingham, UK l.harper@bham.ac.uk l.harper@bham.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': ""Department of Renal Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2018-214245']
816,31618446,Trajectory of criterion symptoms of major depression under newly started antidepressant treatment: sleep disturbances and anergia linger on while suicidal ideas and psychomotor symptoms disappear early.,"OBJECTIVE


In modern psychiatry, depression is diagnosed with the diagnostic criteria; however, the trajectory of each of the criterion symptoms is unknown. This study aims to examine this.
METHODS


We made repeated assessments of the nine diagnostic criterion symptoms with the Patient Health Questionnaire-9 (PHQ-9) among 2011 participants of a 25-week pragmatic randomised controlled trial of sertraline and/or mirtazapine for hitherto untreated major depressive episodes. The changes from baseline were estimated with the mixed-effects model with repeated measures. The time to disappearance of each symptom was modeled using the Kaplan-Meier survival analysis.
RESULTS


The total score on PHQ-9 was 18.5 (SD = 3.9, n = 2011) at baseline, which decreased to 15.3 (5.2, n = 2011) at week 1, to 11.5 (5.9, n = 1953) at week 3, to 7.8 (6.0, n = 1927) at week 9, and to 6.0 (5.9, n = 1910) at week 25. Suicidal ideas, psychomotor symptoms decreased rapidly, while anergia and sleep disturbance also decreased but only slowly. The survival analyses confirmed the primary analyses.
CONCLUSIONS


Upon initiation of antidepressant treatment, patients with newly treated major depressive episodes can expect their suicidal ideas and psychomotor symptoms to disappear first but sleep disturbances and anergia to linger on.",2019,"(PHQ-9) among 2,011 participants of a 25-week pragmatic randomised controlled trial of sertraline and/or mirtazapine for hitherto untreated major depressive episodes.","['2,011 participants of a 25-week pragmatic randomised controlled trial of', 'patients with newly treated major depressive episodes', 'major depression under newly started antidepressant treatment : sleep disturbances and anergia linger on while suicidal ideas and psychomotor symptoms disappear early']",['sertraline and/or mirtazapine'],"['total score on PHQ-9', 'Suicidal ideas, psychomotor symptoms decreased rapidly, while anergia and sleep disturbance']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]",2011.0,0.0935905,"(PHQ-9) among 2,011 participants of a 25-week pragmatic randomised controlled trial of sertraline and/or mirtazapine for hitherto untreated major depressive episodes.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tajika', 'Affiliation': 'Department of Neurosychiatry, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Department of Psychiatry, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic, Nagoya, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mantani', 'Affiliation': 'Mantani Mental Clinic, Hiroshima, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kurata', 'Affiliation': 'Kabe Mental Health Clinic, Hiroshima, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Healthcare Epidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Takeshima', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hayasaka', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Noma', 'Affiliation': 'Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Maruo', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13115']
817,30629148,"First-in-human, Randomized, Double-blind Clinical Trial of Differentially Adjuvanted PAMVAC, A Vaccine Candidate to Prevent Pregnancy-associated Malaria.","BACKGROUND


Malaria in pregnancy has major impacts on mother and child health. To complement existing interventions, such as intermittent preventive treatment and use of impregnated bed nets, we developed a malaria vaccine candidate with the aim of reducing sequestration of asexual ""blood-stage"" parasites in the placenta, the major virulence mechanism.
METHODS


The vaccine candidate PAMVAC is based on a recombinant fragment of VAR2CSA, the Plasmodium falciparum protein responsible for binding to the placenta via chondroitin sulfate A (CSA). Healthy, adult malaria-naive volunteers were immunized with 3 intramuscular injections of 20 μg (n = 9) or 50 μg (n = 27) PAMVAC, adjuvanted with Alhydrogel or glucopyranosyl lipid adjuvant in stable emulsion (GLA-SE) or in a liposomal formulation with QS21 (GLA-LSQ). Allocation was random and double blind. The vaccine was given every 4 weeks. Volunteers were observed for 6 months following last immunization.
RESULTS


All PAMVAC formulations were safe and well tolerated. A total of 262 adverse events (AEs) occurred, 94 (10 grade 2 and 2 grade 3) at least possibly related to the vaccine. No serious AEs occurred. Distribution and severity of AEs were similar in all arms. PAMVAC was immunogenic in all participants. PAMVAC-specific antibody levels were highest with PAMVAC-GLA-SE. The antibodies inhibited binding of VAR2CSA expressing P. falciparum-infected erythrocytes to CSA in a standardized functional assay.
CONCLUSIONS


PAMVAC formulated with Alhydrogel or GLA-based adjuvants was safe, well tolerated, and induced functionally active antibodies. Next, PAMVAC will be assessed in women before first pregnancies in an endemic area.
CLINICAL TRIALS REGISTRATION


EudraCT 2015-001827-21; ClinicalTrials.gov NCT02647489.",2019,"The antibodies inhibited binding of VAR2CSA expressing P. falciparum-infected erythrocytes to CSA in a standardized functional assay.
","['women before first pregnancies in an endemic area', 'Healthy, adult malaria-naive volunteers were immunized with three intramuscular injections of 20 μg (n=9) or 50 μg (n=27']","['PAMVAC, adjuvanted either with Alhydrogel, or with Glucopyranosyl Lipid Adjuvant in stable emulsion (GLA-SE', 'liposomal formulation with QS21 (GLA-LSQ', 'PAMVAC']","['safe and well tolerated', 'Distribution and severity of AE', 'PAMVAC-specific antibody levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}]","[{'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0211668', 'cui_str': 'QS-21'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1277793', 'cui_str': 'Specific antibody measurement'}]",,0.28677,"The antibodies inhibited binding of VAR2CSA expressing P. falciparum-infected erythrocytes to CSA in a standardized functional assay.
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Mihály', 'Initials': 'M', 'LastName': 'Sulyok', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Egger-Adam', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Resende', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'de Jongh', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Mette H', 'Initials': 'MH', 'LastName': 'Jensen', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Helle Holm', 'Initials': 'HH', 'LastName': 'Smedegaard', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Sisse B', 'Initials': 'SB', 'LastName': 'Ditlev', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Soegaard', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Poulsen', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Dyring', 'Affiliation': 'ExpreS2ion Biotechnologies, Horsholm, Denmark.'}, {'ForeName': 'Carlos Lamsfus', 'Initials': 'CL', 'LastName': 'Calle', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Knoblich', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibáñez', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Deloron', 'Affiliation': 'Mère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.'}, {'ForeName': 'Nicaise', 'Initials': 'N', 'LastName': 'Ndam', 'Affiliation': 'Mère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.'}, {'ForeName': 'Saadou', 'Initials': 'S', 'LastName': 'Issifou', 'Affiliation': 'Fondation pour la Recherche Scientifique and Institut de Recherche Clinique du Bénin, Cotonou.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Houard', 'Affiliation': 'European Vaccine Initiative, Heidelberg, Germany.'}, {'ForeName': 'Randall F', 'Initials': 'RF', 'LastName': 'Howard', 'Affiliation': 'Infectious Disease Research Institute, Seattle, Washington.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Reed', 'Affiliation': 'Infectious Disease Research Institute, Seattle, Washington.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Leroy', 'Affiliation': 'European Vaccine Initiative, Heidelberg, Germany.'}, {'ForeName': 'Adrian J F', 'Initials': 'AJF', 'LastName': 'Luty', 'Affiliation': 'Mère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.'}, {'ForeName': 'Thor G', 'Initials': 'TG', 'LastName': 'Theander', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Institut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salanti', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Nielsen', 'Affiliation': 'Centre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1140']
818,31677087,The effect of time spent outdoors during summer on daily blood glucose and steps in women with type 2 diabetes.,"This study investigated changes in glycemic control following a small increase in time spent outdoors. Women participants with type 2 diabetes (N = 46) wore an iBUTTON temperature monitor and a pedometer for 1 week and recorded their morning fasting blood glucose (FBG) daily. They went about their normal activities for 2 days (baseline) and were asked to add 30 min of time outdoors during Days 3-7 (intervention). Linear mixed effects models were used to test whether morning FBG values were different on days following intervention versus baseline days, and whether steps and/or heat exposure changed. Results were stratified by indicators of good versus poor glycemic control prior to initiation of the study. On average, blood glucose was reduced by 6.1 mg/dL (95% CI - 11.5, - 0.6) on mornings after intervention days after adjusting for age, BMI, and ambient weather conditions. Participants in the poor glycemic control group (n = 16) experienced a 15.8 mg/dL decrease (95% CI - 27.1, - 4.5) in morning FBG on days following the intervention compared to a 1.6 mg/dL decrease (95%CI - 7.7, 4.5) for participants in the good glycemic control group (n = 30). Including daily steps or heat exposure did not attenuate the association between intervention and morning FBG. The present study suggests spending an additional 30 min outdoors may improve glycemic control; however, further examination with a larger sample over a longer duration and determination of mediators of this relationship is warranted.",2020,"On average, blood glucose was reduced by 6.1 mg/dL (95% CI - 11.5, - 0.6) on mornings after intervention days after adjusting for age, BMI, and ambient weather conditions.","['Women participants with type 2 diabetes (N\u2009=\u200946', 'women with type 2 diabetes']",[],"['morning FBG values', 'glycemic control', 'morning fasting blood glucose (FBG) daily', 'time spent outdoors', 'blood glucose']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0490201,"On average, blood glucose was reduced by 6.1 mg/dL (95% CI - 11.5, - 0.6) on mornings after intervention days after adjusting for age, BMI, and ambient weather conditions.","[{'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Richardson', 'Affiliation': 'Department of Population Health Sciences, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Chmielewski', 'Affiliation': 'Physiology and Biophysics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Connor Y H', 'Initials': 'CYH', 'LastName': 'Wu', 'Affiliation': 'Department of Geospatial Informatics, Troy University, Troy, AL, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Evans', 'Affiliation': 'Center for the Study of Community Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'McClure', 'Affiliation': 'Department of Epidemiology and Biostatistics, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn W', 'Initials': 'KW', 'LastName': 'Hosig', 'Affiliation': 'Department of Population Health Sciences, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Gohlke', 'Affiliation': 'Department of Population Health Sciences, Virginia Tech, Blacksburg, VA, USA. jgohlke@vt.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00113-5']
819,30590412,Switching From a Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen: A Randomized Clinical Trial to Determine the Effect on Peripheral Blood and Ileum Biopsies From Antiretroviral Therapy-suppressed Human Immunodeficiency Virus-infected Individuals.,"BACKGROUND


Optimization of combination antiretroviral therapy (cART) can impact the human immunodeficiency virus (HIV) reservoir. We evaluated the effect on the HIV reservoir in peripheral blood and ileum biopsies in patients switching from boosted protease inhibitor (PI/r)-based therapy to dolutegravir (DTG)-based therapy.
METHODS


Impact of Integrase-inhibitor DOlutegravir On the viral Reservoir (INDOOR) is a phase 4 open-label clinical trial that randomly included 42 HIV type 1-infected individuals on effective cART: 20 who switched from PI/r-based to DTG-based cART (switch group), and 22 who remained in PI/r-based regimens (control group). We analyzed blood and ileum biopsies to quantify episomal, total, and integrated HIV DNA, cell-associated HIV RNA, residual plasma viremia, T-cell subsets, cell activation, and inflammation markers.
RESULTS


There were no related adverse events or treatment discontinuations due to drug intolerance. The HIV reservoir was consistently larger in ileal than in peripheral CD4+ T cells in both groups (P < .01). Residual viremia in plasma decreased in the switch group (P = .03). However, we did not observe significant longitudinal changes in low-level viral replication, total and integrated HIV reservoir, HIV transcription, T-cell maturation subsets, immunoactivation markers, inflammatory soluble proteins, or cellular markers of latently infected cells.
CONCLUSIONS


The INDOOR study is the first evaluation of changes in HIV reservoir size in ileum biopsies and in peripheral blood in individuals switched from PI/r- to DTG-based cART. Although this switch was safe and well tolerated, it had no impact on a large array of immunological and inflammatory markers or on HIV reservoir markers in peripheral or in ileal CD4+ T cells.
CLINICAL TRIALS REGISTRATION


EudraCT 2014-004331-39.",2019,Residual viremia in plasma decreased in the switch group (p=0.03).,"['42 HIV-1-infected individuals on effective cART: 20 who switched from boosted PI-based to DTG-based cART (switch group), and 22 who remained in boosted PI-based regimens (control group', 'ART-suppressed HIV-infected individuals']","['EudraCT', 'protease inhibitor (PI)-based therapy to dolutegravir (DTG)-based therapy', 'combination antiretroviral therapy (cART']","['safe and well tolerated', 'Residual viremia in plasma', 'adverse events', 'low-level viral replication, total and integrated HIV reservoir, HIV transcription, T-cell maturation subsets, immunoactivation markers, inflammatory soluble proteins, or cellular markers of latently infected cells', 'blood and ileum biopsies to quantify episomal, total, and integrated HIV-DNA, cell-associated HIV-RNA, residual plasma viremia, T-cell subsets, cell activation, and inflammation markers']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442537', 'cui_str': 'Reservoir (environment)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005768'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure (body structure)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C2362651', 'cui_str': 'T cell subsets'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",42.0,0.027668,Residual viremia in plasma decreased in the switch group (p=0.03).,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Morón-López', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Jimenez', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Rutsaert', 'Affiliation': 'Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Urrea', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Puertas', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Torrella', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Clercq', 'Affiliation': 'Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium.'}, {'ForeName': 'Bibiana Planas', 'Initials': 'BP', 'LastName': 'Ribas', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gálvez', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Salgado', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vandekerckhove', 'Affiliation': 'Human Immunodeficiency Virus Cure Research Center, Department of Internal Medicine, Faculty of Medicine and Health Sciences, Ghent University and Ghent University Hospital, Belgium.'}, {'ForeName': 'Julià', 'Initials': 'J', 'LastName': 'Blanco', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': ""Infectious Diseases Department, Hospital Universitari Vall d'Hebron.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martinez-Picado', 'Affiliation': 'AIDS Research Institute IrsiCaixa, Badalona.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1095']
820,30604337,Is sensory-level electrical stimulation effective in cerebral palsy children with dysphagia? A randomized controlled clinical trial.,"Dysphagia is one of the common findings in children with cerebral palsy (CP). Electrical stimulation (ES) has been demonstrated to positively contribute to swallowing functions, particularly in adult patients with various neurological disorders. Therefore, the objective of this study was to assess the effects of sensory-level ES treatment combined with conventional dysphagia rehabilitation in pediatric age group CP patients who had any oropharyngeal dysphagia symptoms and/or findings. Participants were randomly assigned to either the experimental group (Group 1, n = 52) who underwent intermittent galvanic stimulation to bilateral masseter muscles for 5 days/week, for 4 weeks combined with conventional dysphagia rehabilitation or the control group (Group 2, n = 50) who received sham stimulation with conventional dysphagia rehabilitation. The experimental group achieved significantly more improvement in swallowing functions including drooling, tongue movements, chewing, eating large food ability, feeding duration, as well as dysphagia screen test and dysphagia level, compared to control group. This study suggested that sensory-level ES might be a useful and safe therapeutic modality to improve oropharyngeal symptoms, symptom severity and dysphagia level in children with CP and dysphagia. Further research is needed to determine the long-term effects of ES on dysphagia, especially in different neurological disorders such as CP.",2020,"The experimental group achieved significantly more improvement in swallowing functions including drooling, tongue movements, chewing, eating large food ability, feeding duration, as well as dysphagia screen test and dysphagia level, compared to control group.","['children with cerebral palsy (CP', 'adult patients with various neurological disorders', 'pediatric age group CP patients who had any oropharyngeal dysphagia symptoms and/or findings', 'children with CP and dysphagia', 'cerebral palsy children with dysphagia']","['sensory-level ES treatment combined with conventional dysphagia rehabilitation', 'intermittent galvanic stimulation to bilateral masseter muscles for 5 days/week, for 4 weeks combined with conventional dysphagia rehabilitation or the control group (Group 2, n\u2009=\u200950) who received sham stimulation with conventional dysphagia rehabilitation', 'Electrical stimulation (ES']","['Dysphagia', 'swallowing functions including drooling, tongue movements, chewing, eating large food ability, feeding duration, as well as dysphagia screen test and dysphagia level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal Dysphagia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0024876', 'cui_str': 'Masseter Muscle'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.027047,"The experimental group achieved significantly more improvement in swallowing functions including drooling, tongue movements, chewing, eating large food ability, feeding duration, as well as dysphagia screen test and dysphagia level, compared to control group.","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Umay', 'Affiliation': 'Ankara Diskapi Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, University of Health Sciences, Altindag, Ankara, Turkey. ebruumay@gmail.com.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Gurcay', 'Affiliation': 'Gaziler Physical and Rehabilitation Medicine Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Erhan Arif', 'Initials': 'EA', 'LastName': 'Ozturk', 'Affiliation': 'Ankara Diskapi Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, University of Health Sciences, Altindag, Ankara, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Unlu Akyuz', 'Affiliation': 'Ankara Diskapi Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, University of Health Sciences, Altindag, Ankara, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-018-01071-6']
821,30601950,"Noninferiority of Simplified Dolutegravir Monotherapy Compared to Continued Combination Antiretroviral Therapy That Was Initiated During Primary Human Immunodeficiency Virus Infection: A Randomized, Controlled, Multisite, Open-label, Noninferiority Trial.","BACKGROUND


Patients who start combination antiretroviral therapy (cART) during primary human immunodeficiency virus type 1 (HIV-1) infection show a smaller HIV-1 latent reservoir, less immune activation, and less viral diversity compared to patients who start cART during chronic infection. We conducted a pilot study to determine whether these properties would allow sustained virological suppression after simplification of cART to dolutegravir monotherapy.
METHODS


EARLY-SIMPLIFIED is a randomized, open-label, noninferiority trial. Patients who started cART <180 days after a documented primary HIV-1 infection and had an HIV-1 RNA <50 copies/mL plasma for at least 48 weeks were randomized (2:1) to monotherapy with dolutegravir 50 mg once daily or to continuation of cART. The primary efficacy endpoint was the proportion of patients with <50 HIV-1 RNA copies/mL on or before week 48; noninferiority margin 10%.
RESULTS


Of the 101 patients randomized, 68 were assigned to simplification to dolutegravir monotherapy and 33 to continuation of cART. At week 48 in the per-protocol population, 67/67 (100%) had virological response in the dolutegravir monotherapy group vs 32/32 (100%) in the cART group (difference, 0.00%; 95% confidence interval, -100%, 4.76%). This showed noninferiority of the dolutegravir monotherapy at the prespecified level.
CONCLUSION


In this pilot study consisting of patients who initiated cART during primary HIV-1 infection and had <50 HIV-1 RNA copies/mL for at least 48 weeks, monotherapy with once-daily dolutegravir was noninferior to cART. Our results suggest that future simplification studies should use a stratification according to time of HIV infection and start of first cART.
CLINICAL TRIALS REGISTRATION


NCT02551523.",2019,"At week 48 in the per-protocol population, 67/67 (100%) had virological response in the dolutegravir monotherapy group versus 32/32 (100%) in the cART group (difference 0.00%, 95%-CI","['patients who initiated cART <180 days after the estimated day of a documented primary HIV-1 infection and had <50 HIV-1 RNA copies/mL for at least 48 weeks', '101 patients randomized']","['dolutegravir monotherapy', '95%-CI', 'started cART', 'simplified dolutegravir monotherapy', 'monotherapy with once-daily dolutegravir was non-inferior to cART', 'start combination antiretroviral therapy (cART', 'monotherapy with dolutegravir 50 mg once-daily or to continuation of cART']","['virological response', 'proportion of patients with <50 HIV-1 RNA copies/mL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0179636', 'cui_str': 'Cart, device (physical object)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",101.0,0.327696,"At week 48 in the per-protocol population, 67/67 (100%) had virological response in the dolutegravir monotherapy group versus 32/32 (100%) in the cART group (difference 0.00%, 95%-CI","[{'ForeName': 'Dominique L', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Teja', 'Initials': 'T', 'LastName': 'Turk', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tschumi', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grube', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hampel', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Depmeier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Schreiber', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Silvio D', 'Initials': 'SD', 'LastName': 'Brugger', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Greiner', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Steffens', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'De Torrenté-Bayard', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Courlet', 'Affiliation': 'Service of Clinical Pharmacology, University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Neumann', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Kuster', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Flepp', 'Affiliation': 'Center of Infectious Diseases Zurich, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Bertisch', 'Affiliation': 'Checkpoint Zurich, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Decosterd', 'Affiliation': 'Service of Clinical Pharmacology, University Hospital Center, University of Lausanne, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Böni', 'Affiliation': 'Institute of Medical Virology, University of Zurich, Switzerland.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Metzner', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Kouyos', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Huldrych F', 'Initials': 'HF', 'LastName': 'Günthard', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1131']
822,30601976,Dolutegravir Monotherapy Versus Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed People Living With Chronic Human Immunodeficiency Virus Infection: The Randomized Noninferiority MONotherapy of TiviCAY Trial.,"BACKGROUND


We investigated whether dolutegravir (DTG) monotherapy could be used to maintain virological suppression in people living with human immunodeficiency virus (HIV) on a successful dolutegravir-based triple therapy.
METHODS


MONCAY (MONotherapy of TiviCAY) was a 48-week, multicentric, randomized, open-label, 12% noninferiority margin trial. Patients with CD4 nadir >100/μL, plasma HIV-1 RNA <50 copies/mL for ≥12 months, and stable regimen with DTG/abacavir (ABC)/lamivudine (3TC) were 1:1 randomized to continue their regimen or to DTG monotherapy. The primary endpoint was the proportion of patients with HIV RNA <50 copies/mL at week 24 in intention-to-treat snapshot analysis. Virologic failure (VF) was defined as 2 consecutive HIV RNA >50 copies/mL within 2 weeks apart.
RESULTS


Seventy-eight patients were assigned to DTG monotherapy and 80 to continue DTG/ABC/3TC. By week 24, 2 patients in the DTG group experienced VF without resistance to the integrase strand transfer inhibitor (INSTI) class; 1 patient discontinued DTG/ABC/3TC due to an adverse event. The success rate at week 24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm (difference, 2.7%; 95% confidence interval [CI], -5.0 to 10.8). During subsequent follow-up, 5 additional VFs occurred in the DTG arm (2 of which harbored emerging resistance mutation to INSTI). The cumulative incidence of VF at week 48 was 9.7% (95% CI, 2.8 to 16.6) in the DTG arm compared with 0% in the DTG/ABC/3TC arm (P = .005 by the log-rank test). The Data Safety Monitoring Board recommended to reintensify the DTG arm with standardized triple therapy.
CONCLUSIONS


Because the risk of VF with resistance increases over time, we recommend avoiding DTG monotherapy as a maintenance strategy among people living with chronic HIV infection.
CLINICAL TRIALS REGISTRATION


NCT02596334 and EudraCT 2015-002853-36.",2019,"The success rate at W24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm; difference 2.7%, 95% CI: -5.0 to 10.8.","['Seventy-eight patients', 'Patients with CD4 nadir>100/μL, plasma HIV-1 RNA', 'people living with HIV on a successful dolutegravir-based triple-therapy', 'virologically suppressed people living with chronic HIV infection', 'people living with chronic HIV infection']","['dolutegravir/abacavir/lamivudine (DTG/ABC/3TC', 'dolutegravir monotherapy', 'Dolutegravir monotherapy versus dolutegravir/abacavir/lamivudine']","['proportion of patients with HIV RNA', 'Virologic failure (VF', 'cumulative incidence of VF', 'success rate']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0853112', 'cui_str': 'Chronic infection with HIV'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",78.0,0.147554,"The success rate at W24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm; difference 2.7%, 95% CI: -5.0 to 10.8.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Hocqueloux', 'Affiliation': ""Service des Maladies Infectieuses et Tropicales, CHR d'Orléans-La Source, Tours.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Tours.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Prazuck', 'Affiliation': ""Service des Maladies Infectieuses et Tropicales, CHR d'Orléans-La Source, Tours.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Service des Maladies Infectieuses, CHU Bretonneau, Tours.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sunder', 'Affiliation': 'Service des Maladies Infectieuses et Tropicales, CHG de Niort.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Esnault', 'Affiliation': 'Service des Maladies Infectieuses, CHD de Vendée, La Roche-sur-Yon.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rey', 'Affiliation': ""Le Trait d'Union, Hôpitaux Universitaires de Strasbourg.""}, {'ForeName': 'Gwenaël', 'Initials': 'G', 'LastName': 'Le Moal', 'Affiliation': 'Service des Maladies Infectieuses, CHU La Milétrie, Poitiers.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Roncato-Saberan', 'Affiliation': 'Service des Maladies Infectieuses, Groupe Hospitalier de La Rochelle-Ré-Aunis, Nancy.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'André', 'Affiliation': 'Service des Maladies Infectieuses, CHRU-Brabois, Nancy.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Billaud', 'Affiliation': 'Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Tours.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Valéry', 'Affiliation': ""Département d'Informatique Médicale, CHR d'Orléans-La Source, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Avettand-Fènoël', 'Affiliation': 'Laboratoire de Microbiologie clinique, CHU Necker and Université Paris Descartes, Sorbonne Paris Cité.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': ""Unité de Biostatistique et de Recherche Clinique, CHU de Caen; EA2656 Groupe de Recherche sur l'Adaptation Microbienne (GRAM 2.0), Université Caen Normandie, Caen, France.""}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Allavena', 'Affiliation': 'Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Tours.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1132']
823,31674920,"Use of the Chatbot ""Vivibot"" to Deliver Positive Psychology Skills and Promote Well-Being Among Young People After Cancer Treatment: Randomized Controlled Feasibility Trial.","BACKGROUND


Positive psychology interventions show promise for reducing psychosocial distress associated with health adversity and have the potential to be widely disseminated to young adults through technology.
OBJECTIVE


This pilot randomized controlled trial examined the feasibility of delivering positive psychology skills via the Vivibot chatbot and its effects on key psychosocial well-being outcomes in young adults treated for cancer.
METHODS


Young adults (age 18-29 years) were recruited within 5 years of completing active cancer treatment by using the Vivibot chatbot on Facebook messenger. Participants were randomized to either immediate access to Vivibot content (experimental group) or access to only daily emotion ratings and access to full chatbot content after 4 weeks (control). Created using a human-centered design process with young adults treated for cancer, Vivibot content includes 4 weeks of positive psychology skills, daily emotion ratings, video, and other material produced by survivors, and periodic feedback check-ins. All participants were assessed for psychosocial well-being via online surveys at baseline and weeks 2, 4, and 8. Analyses examined chatbot engagement and open-ended feedback on likability and perceived helpfulness and compared experimental and control groups with regard to anxiety and depression symptoms and positive and negative emotion changes between baseline and 4 weeks. To verify the main effects, follow-up analyses compared changes in the main outcomes between 4 and 8 weeks in the control group once participants had access to all chatbot content.
RESULTS


Data from 45 young adults (36 women; mean age: 25 [SD 2.9]; experimental group: n=25; control group: n=20) were analyzed. Participants in the experimental group spent an average of 74 minutes across an average of 12 active sessions chatting with Vivibot and rated their experience as helpful (mean 2.0/3, SD 0.72) and would recommend it to a friend (mean 6.9/10; SD 2.6). Open-ended feedback noted its nonjudgmental nature as a particular benefit of the chatbot. After 4 weeks, participants in the experimental group reported an average reduction in anxiety of 2.58 standardized t-score units, while the control group reported an increase in anxiety of 0.7 units. A mixed-effects models revealed a trend-level (P=.09) interaction between group and time, with an effect size of 0.41. Those in the experimental group also experienced greater reductions in anxiety when they engaged in more sessions (z=-1.9, P=.06). There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion.
CONCLUSIONS


The chatbot format provides a useful and acceptable way of delivering positive psychology skills to young adults who have undergone cancer treatment and supports anxiety reduction. Further analysis with a larger sample size is required to confirm this pattern.",2019,"There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion.
","['45 young adults (36 women; mean age: 25 [SD 2.9]; experimental group: n=25; control group: n=20) were analyzed', 'Young adults (age 18-29 years) were recruited within 5 years of completing active cancer treatment by using the Vivibot chatbot on Facebook messenger', 'Young People', 'young adults treated for cancer', 'young adults who have undergone cancer treatment and supports anxiety reduction']","['positive psychology skills', 'Chatbot ""Vivibot', 'immediate access to Vivibot content (experimental group) or access to only daily emotion ratings and access to full chatbot content after 4 weeks (control']","['average reduction in anxiety', 'chatbot engagement and open-ended feedback on likability and perceived helpfulness', 'depression, positive emotion, or negative emotion', 'anxiety', 'anxiety and depression symptoms and positive and negative emotion changes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0335218', 'cui_str': 'Messenger'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",36.0,0.100779,"There were no significant (or trend level) effects by group on changes in depression, positive emotion, or negative emotion.
","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Greer', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ramo', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Yin-Juei', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Moskowitz', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Haritatos', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/15018']
824,31606362,Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.,"OBJECTIVES


This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.
BACKGROUND


Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.
METHODS


The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.
RESULTS


Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02).
CONCLUSIONS


Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).",2019,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","['20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial ', 'trial randomized patients hospitalized for HF to receive', '79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n\xa0=\xa037,883 [77.2%]; black, n\xa0=\xa011,180 [22.8', 'Decompensated Heart\xa0Failure', 'Decompensated Heart Failure', 'non-Hispanic white (n\xa0=\xa01,494) and black (n\xa0=\xa01,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e.,\xa0Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria', 'from May 2007 to August 2010 and was neutral for clinical endpoints']","['nesiritide or placebo', 'Nesiritide']","['30-day readmission', 'blood pressure and higher ejection fraction', 'mortality rates', 'hospital mortality']","[{'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.20658,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina. Electronic address: stephen.greene@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Forge, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Stanford University, Stanford, California; Verily Life Sciences (Alphabet), South San Francisco, California.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Matsouaka', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Samman Tahhan', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Clyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.07.011']
825,31672070,Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT.,"Objective/Background : Insomnia occurs in 50 to 80% of lung cancer survivors. Cognitive behavioral therapy is the standard treatment for insomnia (CBTI); however, treatment length and lack of psychologists trained in CBTI limits access. Brief Behavioral Treatment for Insomnia (BBTI), a nurse-delivered modified CBTI, is proposed. This feasibility pilot study sought to compare the BBTI intervention to attention control Healthy Eating Program (HEP) for insomnia in lung cancer survivors.  Participants : The participants comprised adults, 21 years of age or older with insomnia and stage I/II non-small cell lung cancer, more than 6 weeks from surgery and living in Western NY.  Methods : Participants (n = 40) were randomly assigned to an experimental (BBTI) or attention control condition (Healthy Eating Program). Thirty participants completed the study.  Results : Participants were 66 years of age (± 7.6; range 53-82), 40% (n = 16) male, 87.5% (n = 35) Caucasian, 50% (n = 20) married, BMI 27.7 (± 5.8), and 12% (n = 5) never smokers. Baseline sleep diary sleep efficiency, ISI and other baseline covariates were balanced between the groups. Sleep efficiency improved ≥85% in BBTI group ( p  = .02), but not in HEP control group ( p  = 1.00). Mean ISI for BBTI and attention control were 6.40 ± 4.98 and 14.10 ± 4.48 ( p  = .001) respectively. In addition, BBTI group mean total FACT-L score improved by 6.66 points from baseline while HEP group score worsened ( p  = .049).  Conclusions : BBTI is a practical, evidence-based, clinically relevant intervention that improved sleep and quality of life in lung cancer survivors with insomnia. Additional research to evaluate efficacy, duration, and implementation strategies are essential.",2020,"Sleep efficiency improved ≥85% in BBTI group ( p  = .02), but not in HEP control group ( p  = 1.00).","['Participants were 66\xa0years of age (± 7.6; range 53-82), 40% (n\xa0=\xa016) male, 87.5% (n\xa0=\xa035', 'lung cancer survivors with insomnia', 'participants comprised adults, 21\xa0years of age or older with insomnia and stage I/II non-small cell lung cancer, more than 6\xa0weeks from surgery and living in Western NY', 'Participants ', 'Thirty participants completed the study', 'Caucasian, 50% (n\xa0=\xa020) married, BMI 27.7 (± 5.8), and 12% (n\xa0=\xa05) never smokers', 'Lung Cancer Survivors', 'lung cancer survivors', 'Methods : Participants (n\xa0=\xa040']","['Cognitive behavioral therapy', 'BBTI intervention to attention control Healthy Eating Program (HEP', 'Nurse-Delivered Brief Behavioral Treatment', 'experimental (BBTI) or attention control condition (Healthy Eating Program', ' ']","['sleep and quality of life', 'Baseline sleep diary sleep efficiency, ISI and other baseline covariates', 'mean total FACT-L score', 'Sleep efficiency', 'Insomnia', 'Mean ISI for BBTI and attention control']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",30.0,0.0998049,"Sleep efficiency improved ≥85% in BBTI group ( p  = .02), but not in HEP control group ( p  = 1.00).","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Dean', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Carleara', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Carla R', 'Initials': 'CR', 'LastName': 'Jungquist', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Klimpt', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Alameri', 'Affiliation': 'Department of Fundamental Nursing, College Nursing, Imam Abdulrahman Bin Faisal University , Dammam, Saudi Arabia.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Ziegler', 'Affiliation': 'Department of Medicine, VA Western New York Health Systems , Buffalo, New York.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Steinbrenner', 'Affiliation': 'Department of Medicine, VA Western New York Health Systems , Buffalo, New York.'}, {'ForeName': 'Elisabeth U', 'Initials': 'EU', 'LastName': 'Dexter', 'Affiliation': 'Department of Medicine, Jacobs School of Medicine , Buffalo, New York.'}, {'ForeName': 'Samjot S', 'Initials': 'SS', 'LastName': 'Dhillon', 'Affiliation': 'Department of Medicine, Jacobs School of Medicine , Buffalo, New York.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Lucke', 'Affiliation': 'Department of Psychiatry, Clinical and Research Institute on Addictions , Buffalo, New York.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Dickerson', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1685523']
826,30597550,The Developmental Sequence and Relations Between Gesture and Spoken Language in Toddlers With Autism Spectrum Disorder.,"In typical development, gestures precede and predict language development. This study examines the developmental sequence of expressive communication and relations between specific gestural and language milestones in toddlers with autism spectrum disorder (ASD), who demonstrate marked difficulty with gesture production and language. Communication skills across five stages (gestures, word approximations, first words, gesture-word combinations, and two-word combinations) were assessed monthly by blind raters for toddlers with ASD participating in an randomized control trial of parent-mediated treatment (N = 42, 12-30 months). Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.",2020,"Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.","['Toddlers With Autism Spectrum Disorder', 'toddlers with autism spectrum disorder (ASD']",[],"['Communication skills across five stages (gestures, word approximations, first words, gesture-word combinations, and two-word combinations']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]",[],"[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}]",,0.0214743,"Findings revealed that toddlers acquired skills following a reliable (vs. idiosyncratic) sequence and the majority of toddlers combined gestures with words before combining words in speech, but in contrast to the pattern observed in typical development, a significant subset acquired pointing after first words.","[{'ForeName': 'Meagan R', 'Initials': 'MR', 'LastName': 'Talbott', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Young', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Vismara', 'Affiliation': 'University of California, Davis.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis.'}]",Child development,['10.1111/cdev.13203']
827,31424550,Genomic investigation of Staphylococcus aureus recovered from Gambian women and newborns following an oral dose of intra-partum azithromycin.,"BACKGROUND


Oral azithromycin given during labour reduces carriage of bacteria responsible for neonatal sepsis, including Staphylococcus aureus. However, there is concern that this may promote drug resistance.
OBJECTIVES


Here, we combine genomic and epidemiological data on S. aureus isolated from mothers and babies in a randomized intra-partum azithromycin trial (PregnAnZI) to describe bacterial population dynamics and resistance mechanisms.
METHODS


Participants from both arms of the trial, who carried S. aureus in day 3 and day 28 samples post-intervention, were included. Sixty-six S. aureus isolates (from 7 mothers and 10 babies) underwent comparative genome analyses and the data were then combined with epidemiological data. Trial registration (main trial): ClinicalTrials.gov Identifier NCT01800942.
RESULTS


Seven S. aureus STs were identified, with ST5 dominant (n = 40, 61.0%), followed by ST15 (n = 11, 17.0%). ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022). In azithromycin-resistant isolates, msr(A) was the main macrolide resistance gene (n = 36, 80%). Ten study participants, from both trial arms, acquired azithromycin-resistant S. aureus after initially harbouring a susceptible isolate. In nine (90%) of these cases, the acquired clone was an msr(A)-containing ST5 S. aureus. Long-read sequencing demonstrated that in ST5, msr(A) was found on an MDR plasmid.
CONCLUSIONS


Our data reveal in this Gambian population the presence of a dominant clone of S. aureus harbouring plasmid-encoded azithromycin resistance, which was acquired by participants in both arms of the study. Understanding these resistance dynamics is crucial to defining the public health drug resistance impacts of azithromycin prophylaxis given during labour in Africa.",2019,"ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022).","['Participants from both arms of the trial, who carried S. aureus in day 3 and day 28 samples post-intervention, were included', 'Sixty-six S. aureus isolates (from 7 mothers and 10 babies', 'resistant S. aureus after initially harbouring a susceptible isolate']","['placebo', 'azithromycin', 'azithromycin prophylaxis']",[],"[{'cui': 'C0230348', 'cui_str': 'Both upper arms (body structure)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]",[],10.0,0.421266,"ST5 predominated in the placebo arm (73.0% versus 49.0%, P = 0.039) and ST15 in the azithromycin arm (27.0% versus 6.0%, P = 0.022).","[{'ForeName': 'Abdoulie', 'Initials': 'A', 'LastName': 'Bojang', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Baines', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Donovan', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Guerillot', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kerrie', 'Initials': 'K', 'LastName': 'Stevens', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Higgs', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ousman', 'Initials': 'O', 'LastName': 'Secka', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Schultz', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Seemann', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Stinear', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roca', 'Affiliation': 'Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Doherty Applied Microbial Genomics, Department of Microbiology & Immunology, The University of Melbourne at The Peter Doherty Institute for Infection & Immunity, Melbourne, Victoria, Australia.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz341']
828,29526341,Randomised feasibility study to compare the use of Therabite ®  with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck.,"Our aim was to compare the efficacy of the Therabite ®  jaw motion rehabilitation system (Atos Medical) with that of wooden spatulas to relieve and prevent trismus in patients who have had radiotherapy for stage three and four oral and oropharyngeal cancer. Secondary aims were to assess the feasibility and the impact of exercise on health-related quality of life (QoL), and the use of health services after treatment. We designed a randomised, open-label, controlled, three-centre feasibility study to compare the effectiveness and cost of the Therabite ®  and wooden spatulas. We studied compliance with exercises and health-related QoL, assessed cost using three health economics measures, and conducted semistructured interviews with patients. Patients were randomised into two groups: the Therabite ®  group (n=37) and the wooden spatula group (n=34). All patients had some sense of jaw tightening before the study started. Mean mouth opening after six months increased in both groups, but the difference between the groups was not significant (p=0.39). Completion rates for the three economic measures were good. There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant.",2018,"There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant.","['patients with cancer of the head and neck', 'patients who have had radiotherapy for stage three and four oral and oropharyngeal cancer']","['Therabite ®  group', 'radiotherapy', 'Therabite ®  with wooden spatulas', 'wooden spatula group']","['ameliorate trismus', 'health-related quality of life (QoL), and the use of health services', 'frequency of contact with care services or in QoL. Exercises', 'efficacy, compliance, QoL, or use of hospital or community health services', 'Mean mouth opening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0557859', 'cui_str': 'Wooden (qualifier value)'}]","[{'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009472', 'cui_str': 'Community Health Services'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",,0.0400784,"There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'The Christie, Research and Development, Manchester, United Kingdom.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Yeo', 'Affiliation': 'Bangor University, Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, Bangor, United Kingdom.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'University Hospital Aintree, Maxillofacial Unit Directorate, Liverpool, United Kingdom.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Caress', 'Affiliation': 'University of Manchester, School of Nursing and Midwifery, Manchester, United Kingdom.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'University of Manchester, School of Nursing and Midwifery, Manchester, United Kingdom; The Hong Kong Polytechnic University, School of Nursing, Hong Kong, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ryder', 'Affiliation': 'The Christie, Research and Development, Manchester, United Kingdom.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': 'University of Birmingham, Clinical Oncology, Birmingham, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lunt', 'Affiliation': 'The Christie, Research and Development, Manchester, United Kingdom.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Scott', 'Affiliation': 'University Hospital Aintree, Clinical Lead Therapist, Liverpool, United Kingdom.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Keeley', 'Affiliation': 'The University of Huddersfield, Department of Health Sciences, Huddersfield, United Kingdom.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Bangor University, Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, Bangor, United Kingdom.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Slevin', 'Affiliation': 'The Christie, Clinical Oncology, Manchester, United Kingdom. Electronic address: nick.slevin@christie.nhs.uk.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2018.02.012']
829,31661077,Examining the Use of Glucose and Physical Activity Self-Monitoring Technologies in Individuals at Moderate to High Risk of Developing Type 2 Diabetes: Randomized Trial.,"BACKGROUND


Self-monitoring of behavior (namely, diet and physical activity) and physiology (namely, glucose) has been shown to be effective in type 2 diabetes (T2D) and prediabetes prevention. By combining self-monitoring technologies, the acute physiological consequences of behaviors could be shown, prompting greater consideration to physical activity levels today, which impact the risk of developing diabetes years or decades later. However, until recently, commercially available technologies have not been able to show individuals the health benefits of being physically active.
OBJECTIVE


The objective of this study was to examine the usage, feasibility, and acceptability of behavioral and physiological self-monitoring technologies in individuals at risk of developing T2D.
METHODS


A total of 45 adults aged ≥40 years and at moderate to high risk of T2D were recruited to take part in a 3-arm feasibility trial. Each participant was provided with a behavioral (Fitbit Charge 2) and physiological (FreeStyle Libre flash glucose monitor) monitor for 6 weeks, masked according to group allocation. Participants were allocated to glucose feedback (4 weeks) followed by glucose and physical activity (biobehavioral) feedback (2 weeks; group 1), physical activity feedback (4 weeks) followed by biobehavioral feedback (2 weeks; group 2), or biobehavioral feedback (6 weeks; group 3). Participant usage (including time spent on the apps and number of glucose scans) was the primary outcome. Secondary outcomes were the feasibility (including recruitment and number of sensor displacements) and acceptability (including monitor wear time) of the intervention. Semistructured qualitative interviews were conducted at the 6-week follow-up appointment.
RESULTS


For usage, time spent on the Fitbit and FreeStyle Libre apps declined over the 6 weeks for all groups. Of the FreeStyle Libre sensor scans conducted by participants, 17% (1798/10,582) recorded rising or falling trends in glucose, and 24% (13/45) of participants changed ≥1 of the physical activity goals. For feasibility, 49% (22/45) of participants completed the study using the minimum number of FreeStyle Libre sensors, and a total of 41 sensors were declared faulty or displaced. For acceptability, participants wore the Fitbit for 40.1 (SD 3.2) days, and 20% (9/45) of participants and 53% (24/45) of participants were prompted by email to charge or sync the Fitbit, respectively. Interviews unearthed participant perceptions on the study design by suggesting refinements to the eligibility criteria and highlighting important issues about the usability, wearability, and features of the technologies.
CONCLUSIONS


Individuals at risk of developing T2D engaged with wearable digital health technologies providing behavioral and physiological feedback. Modifications are required to both the study and to commercially available technologies to maximize the chances of sustained usage and behavior change. The study and intervention were feasible to conduct and acceptable to most participants.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 17545949; isrctn.com/ISRCTN17545949.",2019,"For usage, time spent on the Fitbit and FreeStyle Libre apps declined over the 6 weeks for all groups.","['Individuals at Moderate to High Risk of Developing Type 2 Diabetes', '45 adults aged ≥40 years and at moderate to high risk of T2D', 'individuals at risk of developing T2D.\nMETHODS', 'participants, 17% (1798/10,582) recorded rising or falling trends in glucose, and 24% (13/45) of participants changed ≥1 of the physical activity goals']","['biobehavioral feedback', 'glucose feedback (4 weeks) followed by glucose and physical activity (biobehavioral) feedback', 'physical activity feedback (4 weeks) followed by biobehavioral feedback (2 weeks', 'Self-Monitoring Technologies']","['Participant usage (including time spent on the apps and number of glucose scans', 'feasibility (including recruitment and number of sensor displacements) and acceptability (including monitor wear time) of the intervention', 'Glucose and Physical Activity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0441633'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",45.0,0.0765246,"For usage, time spent on the Fitbit and FreeStyle Libre apps declined over the 6 weeks for all groups.","[{'ForeName': 'Maxine E', 'Initials': 'ME', 'LastName': 'Whelan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Orme', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Kingsnorth', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Sherar', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Denton', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Esliger', 'Affiliation': 'National Centre for Sport and Exercise Medicine, Loughborough University, Loughborough, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/14195']
830,30566636,Comparative Immunogenicity and Safety Trial of 2 Different Schedules of Single-visit Intradermal Rabies Postexposure Vaccination.,"BACKGROUND


Effective and safe single-visit rabies vaccination for pre- and postexposure prophylaxis (PrEP and PEP) could substantially simplify rabies prevention and therefore increase compliance.
METHODS


In a comparative trial, 303 healthy adults received a primary vaccination that consisted of 2 intradermal (ID) doses of 0.1 mL of the purified chicken embryo cell vaccine (PCEV) during a single visit. One year later, participants were randomly assigned to receive either 4 or 2 ID PEP booster doses of 0.1 mL PCEV during a single visit. The primary endpoint for immunogenicity was the percentage of participants with an adequate antibody level (>0.5 IU/mL) 7 days after the booster doses. The safety endpoint was the proportion of participants who developed adverse events (AEs) following primary and/or booster vaccination.
RESULTS


All participants, except 1 (99.3%) in each study group, had a rabies antibody titer >0.5 IU/mL on day 7 following the booster schedules. Participants exposed to the 4-dose PEP schedule had a geometric mean titer of 20 IU/mL vs 14 IU/mL for the 2-dose PEP schedule (P = .0228). Local reactions at the injection site following PrEP and PEP were mild and transient and only seen in 14.9% and 49.6%-53% of the participants, respectively. No serious AEs were reported.
CONCLUSIONS


In healthy adults, a 2-dose (2 × 0.1 mL) single-visit ID PEP schedule was as immunologically adequate and safe as a 4-dose (4 × 0.1 mL) single-visit PEP schedule 7 to 28 months following a 2-dose (2 × 0.1 mL) single-visit ID PREP.
CLINICAL TRIALS REGISTRATION


EudraCT 2014-00183612.",2019,"RESULTS


ll subjects, except one (99.3%) in each study group, had a rabies antibody titer >0.5 IU/mL on day 7 following the booster schedules.","['healthy adults', '303 healthy adults']","['Single-visit Intradermal Rabies Post-exposure', 'PEP booster doses of 0.1mL of PCEV', 'primary vaccination consisting of two intradermal (ID) doses of 0.1mL of the purified chicken embryo cell vaccine (PCEV']","['geometric mean titer', 'immunogenicity', 'rabies antibody titer', 'Local reactions', 'percentage of subjects with an adequate antibody level']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0034494', 'cui_str': 'Hydrophobia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus domesticus'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0034494', 'cui_str': 'Hydrophobia'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",303.0,0.284656,"RESULTS


ll subjects, except one (99.3%) in each study group, had a rabies antibody titer >0.5 IU/mL on day 7 following the booster schedules.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Soentjens', 'Affiliation': 'Center for Infectious Diseases, Queen Astrid Military Hospital, Brussels.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'De Koninck', 'Affiliation': 'Center for Infectious Diseases, Queen Astrid Military Hospital, Brussels.'}, {'ForeName': 'Achilleas', 'Initials': 'A', 'LastName': 'Tsoumanis', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Herssens', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'Dorien', 'Initials': 'D', 'LastName': 'Van Den Bossche', 'Affiliation': 'Center for Infectious Diseases, Queen Astrid Military Hospital, Brussels.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Terryn', 'Affiliation': 'National Reference Centre for Rabies, Sciensano, Brussels.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Van Gucht', 'Affiliation': 'National Reference Centre for Rabies, Sciensano, Brussels.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Center for the Evaluation of Vaccination, University of Antwerp, Belgium.'}, {'ForeName': 'Yven', 'Initials': 'Y', 'LastName': 'Van Herrewege', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bottieau', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy983']
831,30573211,When it's at: An examination of when cognitive change occurs during cognitive therapy for compulsive checking in obsessive-compulsive disorder.,"BACKGROUND AND OBJECTIVES


The cognitive theory of compulsive checking in OCD proposes that checking behaviour is maintained by maladaptive beliefs, including those related to inflated responsibility and those related to reduced memory confidence. This study examined whether and when specific interventions (as part of a new cognitive therapy for compulsive checking) addressing these cognitive targets changed feelings of responsibility and memory confidence.
METHODS


Participants were nine adults with a primary or secondary diagnosis of OCD who reported significant checking symptoms (at least one hour per day) on the Yale-Brown Obsessive-Compulsive Scale. A single-case multiple baseline design was used, after which participants received 12 sessions of cognitive therapy. From the start of the baseline period through to the 1 month post-treatment follow-up assessment session, participants completed daily monitoring of feelings of responsibility, memory confidence, and their time spent engaging in compulsive checking.
RESULTS


Results revealed that feelings of responsibility significantly reduced and memory confidence significantly increased from baseline to immediately post-treatment, with very high effect sizes. Multilevel modelling revealed significant linear changes in feelings of responsibility (i.e., reductions over time) and memory confidence (i.e., increases over time) occurred following the sessions when these were addressed. Finally, we found that improvements in these over the course of the treatment significantly predicted reduced time spent checking.
LIMITATIONS


The small sample size limits our ability to generalize our results.
CONCLUSIONS


Results are discussed in terms of a focus on the timing of change in cognitive therapy.",2020,"Multilevel modelling revealed significant linear changes in feelings of responsibility (i.e., reductions over time) and memory confidence (i.e., increases over time) occurred following the sessions when these were addressed.",['Participants were nine adults with a primary or secondary diagnosis of OCD who reported significant checking symptoms (at least one hour per day) on the Yale-Brown Obsessive-Compulsive Scale'],['cognitive therapy'],"['time spent checking', 'feelings of responsibility (i.e., reductions over time) and memory confidence', 'feelings of responsibility significantly reduced and memory confidence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332138', 'cui_str': 'Secondary diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0556974', 'cui_str': 'hours/day (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",9.0,0.0366161,"Multilevel modelling revealed significant linear changes in feelings of responsibility (i.e., reductions over time) and memory confidence (i.e., increases over time) occurred following the sessions when these were addressed.","[{'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Radomsky', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada. Electronic address: Adam.Radomsky@concordia.ca.'}, {'ForeName': 'Shiu F', 'Initials': 'SF', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': ""Giraldo-O'Meara"", 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Michel J', 'Initials': 'MJ', 'LastName': 'Dugas', 'Affiliation': 'Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Canada.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Gelfand', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Myhr', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, Canada.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Schell', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Senn', 'Affiliation': 'Department of Psychology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Maureen L', 'Initials': 'ML', 'LastName': 'Whittal', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2018.12.003']
832,31604061,Subcutaneous Injection of Hyaluronic Acid to Decrease Acute Skin Toxicity After Adjuvant Interstitial Brachytherapy in Parotid Gland Cancer Patients: A Nonrandomized Controlled Trial.,"PURPOSE


The aim was to evaluate the safety and efficacy of subcutaneous injection of hyaluronic acid in decreasing acute skin toxicity after adjuvant interstitial brachytherapy in parotid gland cancer patients.
MATERIALS AND METHODS


Patients with histologically proven parotid gland cancer who would be treated with adjuvant interstitial brachytherapy were included in this nonrandomized controlled trial. Participants were nonrandomly divided into the experimental group and control group. Participants in the experimental group received an injection of hyaluronic acid subcutaneously immediately after interstitial brachytherapy during the operation. Acute toxicity was evaluated in the first 2 months.
RESULTS


Thirty consecutive participants were included from April to September 2018. Twenty participants were in the experimental group, and 10 were in the control group. The median volume of hyaluronic acid was 8 mL (range, 4 to 11 mL). In total, the incidence of acute skin toxicity was 40% (8 of 20 patients) and 100% (10 of 10 patients) in the experimental group and control group, respectively. The difference in the dose delivered to 90% of the target volume of the affected skin was significant between the pre-plan (mean, 36.93 Gy) and the actuarial quality verification (mean, 27.70 Gy) in the experimental group (P = .004). The difference in scoring of acute skin toxicity was significant between the experimental and control groups (P = .001). No clear correlation was found between the dose delivered to 90% of the target volume of the affected skin and the scoring of acute skin toxicity (P = .266).
CONCLUSIONS


Subcutaneous injection of hyaluronic acid was safe and efficient in decreasing acute skin toxicity after adjuvant interstitial brachytherapy in parotid gland cancer patients according to the preliminary results.",2020,The difference in scoring of acute skin toxicity was significant between the experimental and control groups (P = .001).,"['parotid gland cancer patients', 'Patients with histologically proven parotid gland cancer who would be treated with', 'Thirty consecutive participants were included from April to September 2018', 'Twenty participants were in the experimental group, and 10 were in the control group', 'Parotid Gland Cancer Patients']","['Adjuvant Interstitial Brachytherapy', 'hyaluronic acid', 'Hyaluronic Acid', 'adjuvant interstitial brachytherapy']","['median volume of hyaluronic acid', 'scoring of acute skin toxicity', 'actuarial quality verification', 'acute skin toxicity', 'Acute toxicity', 'Acute Skin', 'Toxicity', 'safety and efficacy']","[{'cui': 'C0030580', 'cui_str': 'Parotid Gland'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303135', 'cui_str': '10Be radioisotope'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy (procedure)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",20.0,0.0366925,The difference in scoring of acute skin toxicity was significant between the experimental and control groups (P = .001).,"[{'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Attending Physician, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Shu-Ming', 'Initials': 'SM', 'LastName': 'Liu', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. Electronic address: kqlsm@126.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Huang', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.005']
833,31856902,Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants.,"BACKGROUND


Infants born extremely preterm are at high risk of dying or suffering from severe brain injuries. Treatment guided by monitoring of cerebral oxygenation may reduce the risk of death and neurologic complications. The SafeBoosC III trial evaluates the effects of treatment guided by cerebral oxygenation monitoring versus treatment as usual. This article describes the detailed statistical analysis plan for the main publication, with the aim to prevent outcome reporting bias and data-driven analyses.
METHODS/DESIGN


The SafeBoosC III trial is an investigator-initiated, randomised, multinational, pragmatic phase III trial with a parallel group structure, designed to investigate the benefits and harms of treatment based on cerebral near-infrared spectroscopy monitoring compared with treatment as usual. Randomisation will be 1:1 stratified for neonatal intensive care unit and gestational age (lower gestational age (< 26 weeks) compared to higher gestational age (≥ 26 weeks)). The primary outcome is a composite of death or severe brain injury at 36 weeks postmenstrual age. Primary analysis will be made on the intention-to-treat population for all outcomes, using mixed-model logistic regression adjusting for stratification variables. In the primary analysis, the twin intra-class correlation coefficient will not be considered. However, we will perform sensitivity analyses to address this. Our simulation study suggests that the inclusion of multiple births is unlikely to significantly affect our assessment of intervention effects, and therefore we have chosen the analysis where the twin intra-class correlation coefficient will not be considered as the primary analysis.
DISCUSSION


In line with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines, we have developed and published this statistical analysis plan for the SafeBoosC III trial, prior to any data analysis.
TRIAL REGISTRATION


ClinicalTrials.org, NCT03770741. Registered on 10 December 2018.",2019,"Our simulation study suggests that the inclusion of multiple births is unlikely to significantly affect our assessment of intervention effects, and therefore we have chosen the analysis where the twin intra-class correlation coefficient will not be considered as the primary analysis.
","['Infants born extremely preterm', 'neonatal intensive care unit and gestational age (lower gestational age (<\u200926\u2009weeks) compared to higher gestational age (≥\u200926\u2009weeks', 'extremely preterm infants']",['cerebral oxygenation monitoring'],"['risk of death and neurologic complications', 'composite of death or severe brain injury']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}]","[{'cui': 'C0513563', 'cui_str': 'Oxygenation monitoring (regime/therapy)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}]",,0.231425,"Our simulation study suggests that the inclusion of multiple births is unlikely to significantly affect our assessment of intervention effects, and therefore we have chosen the analysis where the twin intra-class correlation coefficient will not be considered as the primary analysis.
","[{'ForeName': 'Mathias Lühr', 'Initials': 'ML', 'LastName': 'Hansen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. mathias.safeboosc@gmail.com.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Pellicer', 'Affiliation': 'Department of Neonatology, La Paz University Hospital, Paseo De La Castellana 261, 28046, Madrid, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Dempsey', 'Affiliation': 'Infant Centre and Department of Paediatrics and Child Health, University College Cork, College Road, Cork, Ireland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mintzer', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Mountainside Medical Center, Montclair, NJ, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hyttel-Sorensen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Heuchan', 'Affiliation': 'Department of Neonatology, Royal Hospital for Children, 1345 Govan Rd, Glasgow, G51 4TF, UK.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Hagmann', 'Affiliation': ""Department of Neonatology, Children's University Hospital of Zürich, Steinweisstrasse 75, 8037, Zurich, Switzerland.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Dimitriou', 'Affiliation': 'NICU, Department of Pediatrics, University General Hospital of Patras, 265 04, Patras, Greece.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Pichler', 'Affiliation': 'Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 30, Graz, Austria.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Naulaers', 'Affiliation': 'Department of Neonatology, University Hospital Leuven, Herestraat 49, Leuven, Belgium.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': ""Department of Neonatology, Children's Hospital of Fudan University, 399 Wanyuan Rd, Minhang Qu, Shanghai Shi, China.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Vilan', 'Affiliation': 'Department of Neonatology, Centrohospitalar Universitário de São João, Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Tkaczyk', 'Affiliation': 'Department of Neonatology, University Hospital Motol, V Uvalu 84, 150 06, Prague 5, Czech Republic.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Kreutzer', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tuebingen, Hoppe-Seyler-Straße 1, 72076, Tuebingen, Germany.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fumagalli', 'Affiliation': 'Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Via della Commenda 12, 20122, Milan, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Claris', 'Affiliation': 'Department of Neonatology, Hospices Civil De Lyon, 3 Quai des Célestins, 69002, Lyon, France.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Fredly', 'Affiliation': 'Department of Neonatology, Oslo University Hospital, Kirkeveien, 166 0450, Oslo, Norway.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Szczapa', 'Affiliation': 'Department of Neonatology, Poznan University of Medical Sciences, Polna 33, 60-535, Poznań, Poland.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Section of Biostatistics, Department of Publich Health, Copenhagen University, Øster Farimagsgade 5, Copenhagen K, Denmark.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-019-3756-y']
834,29317348,Paediatric in-hospital cardiac arrest: Factors associated with survival and neurobehavioural outcome one year later.,"OBJECTIVE


To investigate clinical characteristics associated with 12-month survival and neurobehavioural function among children recruited to the Therapeutic Hypothermia after Paediatric Cardiac Arrest In-Hospital trial.
METHODS


Children (n = 329) with in-hospital cardiac arrest who received chest compressions for ≥2 min, were comatose, and required mechanical ventilation after return of circulation were included. Neurobehavioural function was assessed using the Vineland Adaptive Behaviour Scales, second edition (VABS-II) at baseline (reflecting pre-arrest status) and 12 months post-arrest. Norms for VABS-II are 100 (mean) ±15 (SD). Higher scores indicate better functioning. Outcomes included 12-month survival, 12-month survival with VABS-II decreased by ≤15 points from baseline, and 12-month survival with VABS-II ≥70.
RESULTS


Asystole as the initial arrest rhythm, administration of >4 adrenaline doses, and higher post-arrest blood lactate concentration were independently associated with lower 12-month survival; an adrenaline dosing interval of 3-<5 min and open chest compressions were independently associated with greater 12-month survival. Use of extracorporeal membrane oxygenation (ECMO) and higher blood lactate were independently associated with lower 12-month survival with VABS-II decreased by ≤15 points from baseline; open chest compressions was independently associated with greater 12-month survival with VABS-II decreased by ≤15 points. Asystole as the initial rhythm, use of ECMO, and higher blood lactate were independently associated with lower 12-month survival with VABS-II ≥70; open chest compressions was independently associated with greater 12-month survival with VABS-II ≥70.
CONCLUSIONS


Cardiac arrest and resuscitation factors are associated with long-term survival and neurobehavioural function among children who are comatose after in-hospital arrest.",2018,Use of extracorporeal membrane oxygenation (ECMO) and higher blood lactate were independently associated with lower 12-month survival with VABS-II decreased by ≤15 points from baseline; open chest compressions was independently associated with greater 12-month survival with VABS-II decreased by ≤15 points.,"['children recruited to the Therapeutic Hypothermia after Paediatric Cardiac Arrest In-Hospital trial', 'children who are comatose after in-hospital arrest', 'Children (n\u202f=\u202f329) with in-hospital cardiac arrest who received chest compressions for ≥2\u202fmin, were comatose, and required mechanical ventilation after return of circulation were included']","['adrenaline', 'extracorporeal membrane oxygenation (ECMO']","['Neurobehavioural function', '12-month survival', '12-month survival, 12-month survival with VABS-II decreased by ≤15 points from baseline, and 12-month survival with VABS-II ≥70', 'blood lactate', 'higher post-arrest blood lactate concentration', 'Vineland Adaptive Behaviour Scales, second edition (VABS-II']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}]",329.0,0.0276949,Use of extracorporeal membrane oxygenation (ECMO) and higher blood lactate were independently associated with lower 12-month survival with VABS-II decreased by ≤15 points from baseline; open chest compressions was independently associated with greater 12-month survival with VABS-II decreased by ≤15 points.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Meert', 'Affiliation': ""Children's Hospital of Michigan, Wayne State University, 3901 Beaubien Boulevard, Detroit, MI, 48201, USA. Electronic address: kmeert@med.wayne.edu.""}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Telford', 'Affiliation': 'University of Utah, 295 Chipeta Way, P. O. Box 581289, Salt Lake City, UT, 84158, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'University of Utah, 295 Chipeta Way, P. O. Box 581289, Salt Lake City, UT, 84158, USA.'}, {'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Slomine', 'Affiliation': 'Kennedy Krieger Institute, Johns Hopkins University, 707 North Broadway, Baltimore, MD, 21205, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Kennedy Krieger Institute, Johns Hopkins University, 707 North Broadway, Baltimore, MD, 21205, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': ""Children's National Health System, 111 Michigan Avenue, NW, Washington, DC 20010, USA.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ofori-Amanfo', 'Affiliation': ""The Children's Hospital at Montefiore, 3415 Bainbridge Avenue, Bronx, NY, 10467, USA.""}, {'ForeName': 'Christopher J L', 'Initials': 'CJL', 'LastName': 'Newth', 'Affiliation': ""Children's Hospital Los Angeles, 4650 Sunset Boulevard, Los Angeles, CA 90027, USA.""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'University of Utah, 295 Chipeta Way, P. O. Box 581289, Salt Lake City, UT, 84158, USA.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Moler', 'Affiliation': ""University of Michigan, CS Mott Children's Hospital, 1540 East Hospital Drive, Ann Arbor, MI, 48109, USA.""}]",Resuscitation,['10.1016/j.resuscitation.2018.01.013']
835,30462182,Treatment Outcomes of Colistin- and Carbapenem-resistant Acinetobacter baumannii Infections: An Exploratory Subgroup Analysis of a Randomized Clinical Trial.,"BACKGROUND


We evaluated the association between mortality and colistin resistance in Acinetobacter baumannii infections and the interaction with antibiotic therapy.
METHODS


This is a secondary analysis of a randomized controlled trial of patients with carbapenem-resistant gram-negative bacterial infections treated with colistin or colistin-meropenem combination. We evaluated patients with infection caused by carbapenem-resistant A. baumannii (CRAB) identified as colistin susceptible (CoS) at the time of treatment and compared patients in which the isolate was confirmed as CoS with those whose isolates were retrospectively identified as colistin resistant (CoR) when tested by broth microdilution (BMD). The primary outcome was 28-day mortality.
RESULTS


Data were available for 266 patients (214 CoS and 52 CoR isolates). Patients with CoR isolates had higher baseline functional capacity and lower rates of mechanical ventilation than patients with CoS isolates. All-cause 28-day mortality was 42.3% (22/52) among patients with CoR strains and 52.8% (113/214) among patients with CoS isolates (P = .174). After adjusting for variables associated with mortality, the mortality rate was lower among patients with CoR isolates (odds ratio [OR], 0.285 [95% confidence interval {CI}, .118-.686]). This difference was associated with treatment arm: Mortality rates among patients with CoR isolates were higher in those randomized to colistin-meropenem combination therapy compared to colistin monotherapy (OR, 3.065 [95% CI, 1.021-9.202]).
CONCLUSIONS


Colistin resistance determined by BMD was associated with lower mortality among patients with severe CRAB infections. Among patients with CoR isolates, colistin monotherapy was associated with a better outcome compared to colistin-meropenem combination therapy.
CLINICAL TRIALS REGISTRATION


NCT01732250.",2019,"This difference was associated with treatment arm: mortality rates among patients with CoR isolates were higher in those randomized to colistin-meropenem combination compared to colistin monotherapy (OR 3.065, 95%CI 1.021-9.202).
","['patients with CoR isolates', 'patients with carbapenem-resistant Gram-negative bacterial infections treated with colistin or colistin-meropenem combination', 'patients with infection caused by carbapenem-resistant A. baumannii (CRAB) initially found to be colistin-susceptible (CoS) at the time of treatment and compared patients in which the isolate was confirmed to be colistin-susceptible with those whose isolates were retrospectively found to be colistin-resistant (CoR) when tested by broth microdilution (BMD', 'patients with severe CRAB infections', '266 patients with CRAB; 214 colistin-susceptible and 52 colistin-resistant isolates']","['colistin and carbapenem-resistant Acinetobacter baumannii infections', 'colistin monotherapy']","['mortality rates', 'baseline functional capacity and lower rates of mechanical ventilation', 'mortality, the mortality rate', '28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0006968', 'cui_str': 'Antibiotics, Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0085423', 'cui_str': 'Gram-Negative Bacterial Infections'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030759', 'cui_str': 'Pubic louse infestation'}]","[{'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C4275270', 'cui_str': 'Carbapenem resistant Acinetobacter baumannii'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",266.0,0.0778172,"This difference was associated with treatment arm: mortality rates among patients with CoR isolates were higher in those randomized to colistin-meropenem combination compared to colistin monotherapy (OR 3.065, 95%CI 1.021-9.202).
","[{'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Dickstein', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Ministry of Health, Tel-Aviv.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lellouche', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Ministry of Health, Tel-Aviv.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Ben Dalak Amar', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Ministry of Health, Tel-Aviv.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schwartz', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Ministry of Health, Tel-Aviv.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nutman', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Ministry of Health, Tel-Aviv.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Daitch', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat-Aviv.'}, {'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Yahav', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat-Aviv.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Leibovici', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat-Aviv.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Skiada', 'Affiliation': 'First Department of Medicine, Laikon General Hospital, Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Antoniadou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Daikos', 'Affiliation': 'First Department of Medicine, Laikon General Hospital, Athens, Greece.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Andini', 'Affiliation': ""Department of Precision Medicine, University of Campania 'L Vanvitelli' and Azienda Ospedaliera di Rilievo Nazionale dei Colli-Monaldi Hospital, Napoli, Italy.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Zampino', 'Affiliation': ""Department of Precision Medicine, University of Campania 'L Vanvitelli' and Azienda Ospedaliera di Rilievo Nazionale dei Colli-Monaldi Hospital, Napoli, Italy.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Durante-Mangoni', 'Affiliation': ""Department of Precision Medicine, University of Campania 'L Vanvitelli' and Azienda Ospedaliera di Rilievo Nazionale dei Colli-Monaldi Hospital, Napoli, Italy.""}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Lena E', 'Initials': 'LE', 'LastName': 'Friberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Sweden.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Dishon Benattar', 'Affiliation': 'Institute of Infectious Diseases, Rambam Health Care Campus.'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Bitterman', 'Affiliation': 'Institute of Infectious Diseases, Rambam Health Care Campus.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Neuberger', 'Affiliation': 'Institute of Infectious Diseases, Rambam Health Care Campus.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Carmeli', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Ministry of Health, Tel-Aviv.'}, {'ForeName': 'Mical', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Institute of Infectious Diseases, Rambam Health Care Campus.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy988']
836,31856912,Regorafenib plus FOLFIRI with irinotecan dose escalated according to uridine diphosphate glucuronosyltransferase 1A1genotyping in previous treated metastatic colorectal cancer patients:study protocol for a randomized controlled trial.,"BACKGROUND


Regorafenib is an oral multikinase inhibitor for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidines, irinotecan, oxaliplatin, monoclonal antibodies targeting vascular endothelial growth factor, and monoclonal antibodies targeting epidermal growth factor receptor. A dose reduction from 160 mg to 120 mg regorafenib reduces regorafenib-associated adverse events (AEs). Dose adjustment of irinotecan in a 5-fluorouracil/leucovorin/irinotecan (FOLFIRI) regimen on the basis of an individual uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) genotype provides optimal oncological outcomes with acceptable AEs. The aim of this study is to address the efficacy and safety of a dose-adjusted combination of regorafenib and FOLFIRI for patients with mCRC.
METHODS


A prospective, multicenter, randomized in a 2:1 ratio, controlled, clinical trial with two parallel arms will be conducted to compare irinotecan dose-escalated FOLFIRI according to UGT1A1 genotyping plus 120 mg regorafenib with 120 mg regorafenib alone in previously treated patients with mCRC. The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, disease control rate, time to progression, and duration of treatment. Safety assessments will also be recorded.
DISCUSSION


Dose adjustment for regorafenib and irinotecan makes treatment-related AEs tolerable and makes the concomitant treatment practicable. This study will provide initial evidence regarding the efficacy and safety of a new combination of chemotherapy and a targeted agent for mCRC.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03880877. Prospectively registered on 19 March 2019.",2019,A dose reduction from 160 mg to 120 mg regorafenib reduces regorafenib-associated adverse events (AEs).,"['previous treated metastatic colorectal cancer patients', 'patients with mCRC', 'previously treated patients with mCRC', 'metastatic colorectal cancer (mCRC']","['fluoropyrimidines, irinotecan, oxaliplatin', 'irinotecan', 'Regorafenib plus FOLFIRI with irinotecan', 'regorafenib alone', '5-fluorouracil/leucovorin/irinotecan (FOLFIRI', 'regorafenib and irinotecan', 'regorafenib and FOLFIRI']","['efficacy and safety', 'progression-free survival', 'regorafenib-associated adverse events (AEs', 'overall survival, disease control rate, time to progression, and duration of treatment']","[{'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}]",,0.207026,A dose reduction from 160 mg to 120 mg regorafenib reduces regorafenib-associated adverse events (AEs).,"[{'ForeName': 'Cheng-Jen', 'Initials': 'CJ', 'LastName': 'Ma', 'Affiliation': 'Division of Digestive and General Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Kun', 'Initials': 'TK', 'LastName': 'Chang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Yung-Sung', 'Initials': 'YS', 'LastName': 'Yeh', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Yu-Tang', 'Initials': 'YT', 'LastName': 'Chang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, 807, Taiwan. cy614112@ms14.hinet.net.'}]",Trials,['10.1186/s13063-019-3917-z']
837,31573838,Isometric exercises and somatosensory training as intervention programmes for patellofemoral pain in young dancers.,"Patellofemoral pain (PPF) is a common problem experienced by young dancers. Currently, there is no clear indication as to the optimal intervention programme for reducing the level of pain and improving functional abilities in young dancers with PFP. Our aim was to examine the efficacy of two intervention programmes compared with controls in relation to PFP symptoms (shown by pain level, Grinding test, and patellar inhibition test-PIT) and functional abilities of dancers with PFP. Ninety-eight young dancers (mean age 13.4 ± .97) with PFP were assessed for clinical parameters and functional abilities pre and post an intervention programme lasting 12 weeks. Using cluster sampling controlling for grade and school, the dancers were divided into three groups: isometric exercises (IE), somatosensory training (ST), and control (CO). Post-intervention, significantly lower pain levels upon patellar provocation testing were reported for the two treatment groups compared with controls. There was a significantly lower rate of legs recovered in the CO group compared with both intervention groups on the Grinding test, and on the PIT. Postural balance ability and proprioception abilities were significantly better post-treatment for the two treatment groups compared with controls. A significant interaction showed that hip abduction muscle strength improved more in the IE group.  In conclusion , both isometric exercises and somatosensory training were effective for decreasing clinical symptoms and improving some functional abilities in young dancers with PFP. Further studies on these types of interventions could determine the most effective training protocol for prevention and treatment of PFP in young dancers.",2020,"There was a significantly lower rate of legs recovered in the CO group compared with both intervention groups on the Grinding test, and on the PIT.","['young dancers with PFP', 'patellofemoral pain in young dancers', 'Ninety-eight young dancers (mean age 13.4±.97) with PFP']","['isometric exercises (IE), somatosensory training (ST), and control (CO', 'isometric exercises and somatosensory training', 'Isometric exercises and somatosensory training', 'CO']","['Postural balance ability and proprioception abilities', 'Patellofemoral pain (PPF', 'hip abduction muscle strength', 'functional abilities', 'pain levels', 'rate of legs']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0335081', 'cui_str': 'Dancer (occupation)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",98.0,0.02123,"There was a significantly lower rate of legs recovered in the CO group compared with both intervention groups on the Grinding test, and on the PIT.","[{'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Steinberg', 'Affiliation': 'The Wingate College of physical Education and Sports Sciences, The Wingate Institute, Netanya, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Tenenbaum', 'Affiliation': 'Department of orthopedic surgery, Chaim Sheba medical center Tel-Hashomer, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Waddington', 'Affiliation': 'Faculty of Health, University of Canberra, Canberra, Australia.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'Faculty of Health, University of Canberra, Canberra, Australia.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Zakin', 'Affiliation': 'The Wingate College of physical Education and Sports Sciences, The Wingate Institute, Netanya, Israel.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Zeev', 'Affiliation': 'The Wingate College of physical Education and Sports Sciences, The Wingate Institute, Netanya, Israel.'}, {'ForeName': 'Itzhak', 'Initials': 'I', 'LastName': 'Siev-Ner', 'Affiliation': 'Orthopedic Rehabilitation Dept., Sheba Medical Center, Tel-Hashomer, Israel.'}]",European journal of sport science,['10.1080/17461391.2019.1675766']
838,29880436,Association Between Height and Clinical Outcome in Metastatic Colorectal Cancer Patients Enrolled Onto a Randomized Phase 3 Clinical Trial: Data From the FIRE-3 Study.,"BACKGROUND


Previous studies have found significant relationships between height and colorectal cancer (CRC) risk. Increased growth has been associated with activated pathways such as insulin-like growth factor 1. This study examined the impact of height on outcomes in metastatic CRC patients enrolled onto the FIRE-3 study, a randomized phase 3 clinical trial.
PATIENTS AND METHODS


A total of 695 patients with metastatic CRC were studied and height was measured in centimeters. Male patients were grouped as ≤ 165, 166-175, 176-185, and ≥ 186 cm in height; female patients were grouped as ≤ 154, 155-164, 165-174, and ≥ 175 cm in height. Primary end point was overall survival (OS); secondary end point was progression-free survival.
RESULTS


When patients' heights were categorized into 4 groups, the tallest group showed a worse OS compared to the shortest group; however, there was no linear relationship between height and OS. To investigate this, we showed the association between height as a continuous variable and OS. Patients shorter than 172 cm had a worse OS as their height decreased. Patients taller than 172 cm had a worse OS as their height increased. Moreover, patients with heights between 165 and 179 cm had a better OS compared to other patients (P = .05). This effect was independent of treatment arm and gender.
CONCLUSION


Patients shorter than 165 cm and taller than 179 cm have a worse OS, while those between 165 and 179 cm have a better OS. Hence, clinicians should consider height as an important prognostic factor when treating metastatic CRC patients. Future prospective studies are warranted to shed light on the mechanisms underlying the worse OS in taller patients.",2018,"Moreover, patients with heights between 165 and 179 cm had a better OS compared to other patients (P = .05).","['Male patients were grouped as\xa0≤ 165, 166-175, 176-185, and\xa0≥ 186 cm in height; female patients were grouped as\xa0≤ 154, 155-164, 165-174, and\xa0≥ 175 cm in height', 'metastatic CRC patients', '695 patients with metastatic CRC', 'taller patients', 'metastatic CRC patients enrolled onto the FIRE-3 study', 'Metastatic Colorectal Cancer Patients Enrolled Onto a Randomized Phase 3 Clinical Trial']",[],['overall survival (OS); secondary end point was progression-free survival'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",695.0,0.0206761,"Moreover, patients with heights between 165 and 179 cm had a better OS compared to other patients (P = .05).","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McSkane', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Comprehensive Cancer Center, Ludwig-Maximilian-University of Munich, Munich, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Comprehensive Cancer Center, Ludwig-Maximilian-University of Munich, Munich, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Puccini', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Madiha', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA; Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA. Electronic address: lenz@med.usc.edu.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Jelas', 'Affiliation': 'Comprehensive Cancer Center, Ludwig-Maximilian-University of Munich, Munich, Germany.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2018.05.003']
839,29305927,Neurobehavioural outcomes in children after In-Hospital cardiac arrest.,"AIM


Children who remain comatose after in-hospital cardiac arrest (IH-CA) resuscitation are at risk for poor neurological outcome. We report results of detailed neurobehavioural testing in paediatric IH-CA survivors, initially comatose after return of circulation, and enrolled in THAPCA-IH, a clinical trial that evaluated two targeted temperature management interventions (hypothermia, 33.0 °C or normothermia, 36.8 °C; NCT00880087).
METHODS


Children, aged 2 days to <18 years, were enrolled in THAPCA-IH from 2009 to 2015; primary trial outcome (survival with favorable neurobehavioural outcome) did not differ between groups. Pre-IH-CA neurobehavioural functioning, measured with the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) was evaluated soon after enrollment; this report includes only children with broadly normal pre-IH-CA scores (VABS-II composite scores ≥70; 269 enrolled). VABS-II was re-administered 3 and 12 months later. Cognitive testing was completed at 12 months.
RESULTS


Follow-ups were obtained on 125 of 135 eligible one-year survivors. Seventy-seven percent (96/125) had VABS-II scores ≥70 at 12 months; cognitive composites were ≥2SD of mean in 59%. VABS-II composite, domain, and most subdomain scores declined between pre-IH-CA and 3-month, and pre-IH-CA and 12-month assessments (composite means declined about 1 SD at 3 and 12 months, p < 0.005); 3 and 12-month scores were strongly correlated (r = 0.72, p < 0.001).
CONCLUSIONS


In paediatric IH-CA survivors at high risk for unfavorable outcomes, the majority demonstrated significant declines in neurobehavioural functioning, across multiple functional domains, with similar functioning at 3 and 12 months. About three-quarters attained VABS-II functional performance composite scores within the broadly normal range.",2018,Seventy-seven percent (96/125) had VABS-II scores ≥70 at 12 months; cognitive composites were ≥2SD of mean in 59%.,"['children after In-Hospital cardiac arrest', 'Children who remain comatose after in-hospital cardiac arrest (IH-CA) resuscitation', 'Children, aged 2\u202fdays to <18\u202fyears, were enrolled in THAPCA-IH from 2009 to 2015; primary trial outcome (survival with favorable neurobehavioural outcome) did not differ between groups', 'paediatric IH-CA survivors, initially comatose after return of circulation, and enrolled in THAPCA-IH']",[],"['Vineland Adaptive Behavior Scales, Second Edition (VABS-II', 'VABS-II functional performance composite scores', 'Neurobehavioural outcomes', 'Cognitive testing', 'VABS-II composite, domain, and most subdomain scores', 'neurobehavioural functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",[],"[{'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0441795', 'cui_str': 'Second edition (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",,0.0544378,Seventy-seven percent (96/125) had VABS-II scores ≥70 at 12 months; cognitive composites were ≥2SD of mean in 59%.,"[{'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Slomine', 'Affiliation': 'Kennedy Krieger Institute, 707 North Broadway, Baltimore, MD 21205, United States; Johns Hopkins University, School of Medicine, Baltimore, MD 21205, United States. Electronic address: slomine@kennedykrieger.org.'}, {'ForeName': 'Faye S', 'Initials': 'FS', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Kennedy Krieger Institute, 707 North Broadway, Baltimore, MD 21205, United States; Johns Hopkins University, School of Medicine, Baltimore, MD 21205, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'Department of Pediatrics, University of Utah, 295 Chipeta Way, P. O. Box 58128, Salt Lake City, UT 84158, United States.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Telford', 'Affiliation': 'Department of Pediatrics, University of Utah, 295 Chipeta Way, P. O. Box 58128, Salt Lake City, UT 84158, United States.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, 295 Chipeta Way, P. O. Box 58128, Salt Lake City, UT 84158, United States.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Moler', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Resuscitation,['10.1016/j.resuscitation.2018.01.002']
840,27966023,"Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.","PURPOSE


High-dose chemotherapy prior to autologous stem cell transplantation (ASCT) leads to adverse effects including mucositis, neutropenia and bacteremia. To reduce the toxicity, we treated myeloma and lymphoma patients with peroral bismuth as an adjuvant to chemotherapy to convey cytoprotection in non-malignant cells.
METHODS


This trial was a prospective, randomised, double-blind, placebo-controlled pilot study of hematological inpatients (n = 50) receiving bismuth or placebo tablets, in order to identify any potential superiority of bismuth on toxicity from chemotherapy.
RESULTS


We show for the first time that bismuth significantly reduces grade 2 stomatitis, febrile neutropenia and infections caused by melphalan in multiple myeloma, where adverse effects also were significantly linked to gender. In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo. Also, lymphoma patients' adverse effects were linked to gender. For the first time, bismuth is demonstrated as a safe strategy against chemotherapy's toxicity without interfering with intentional anti-cancer efficiency. Also, we show how gender significantly influences various adverse effects and response to treatment in both multiple myeloma and malignant lymphomas.
CONCLUSION


These results may impact clinical prevention of chemotherapy's cytotoxicity in certain patient groups, and also, this study may direct further attention towards the impact of gender during the course and treatment outcome of malignant disorders.",2017,"In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo.","['hematological inpatients (n\xa0=\xa050) receiving', 'patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation']","['bismuth or placebo tablets', 'Bismuth adjuvant', 'placebo', 'autologous stem cell transplantation (ASCT', 'peroral bismuth']","['toxicity', 'mucositis, neutropenia and bacteremia', 'diarrhoea', 'grade 2 stomatitis, febrile neutropenia and infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",50.0,0.265311,"In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo.","[{'ForeName': 'Per Boye', 'Initials': 'PB', 'LastName': 'Hansen', 'Affiliation': 'Department of Hematology, Herlev Hospital, University of Copenhagen, 2720, Herlev, Denmark. pbhn@regionsjaelland.dk.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Penkowa', 'Affiliation': 'Section for Neuroprotection, Hjerneeksperten, 1718, Copenhagen, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-016-3522-6']
841,30552406,"Effects of sartans and low-dose statins on cerebral white matter hyperintensities and cognitive function in older patients with hypertension: a randomized, double-blind and placebo-controlled clinical trial.","Cerebral white matter hyperintensities (WMHs) and cognitive impairment are common in elderly hypertensive patients, and more needs to be learned about their prevention and treatment. Our aim was to investigate the effect of low-dose statins on WMH and cognitive function in elderly patients undergoing antihypertensive treatment. A total of 732 elderly hypertensive patients taking hydrochlorothiazide as their baseline medication were randomized using a 2 × 2 factorial design with antihypertensive (telmisartan vs. placebo) and lipid-modulating (low-dose rosuvastatin vs. placebo) arms. Brain magnetic resonance imaging (MRI) and cognitive function data were obtained. After a mean follow-up time of 59.8 (range 12-65) months, there were no differences in WMH progression and cognitive function decline over time between the groups in the antihypertensive arm. The risks of new-incident WMH Fazekas scale scores ≥ 2 and the incidence of cognitive impairment did not differ between the telmisartan and placebo groups. Rosuvastatin use was associated with lower risks of new-incident Fazekas scale scores ≥2 (hazard ratio = 0.500; 95% confidence interval: 0.34-0.74) and cognitive impairment (hazard ratio = 0.54; 95% confidence interval: 0.36-0.80). Telmisartan interacted with rosuvastatin on reducing WMH progression and cognitive function decline. Findings suggest that low-dose rosuvastatin could reduce WMH progression and cognitive function decline in antihypertensive patients, as demonstrated by the interaction between telmisartan and low-dose rosuvastatin to this effect.",2019,The risks of new-incident WMH Fazekas scale scores ≥ 2 and the incidence of cognitive impairment did not differ between the telmisartan and placebo groups.,"['732 elderly hypertensive patients taking', 'elderly hypertensive patients', 'elderly patients undergoing antihypertensive treatment', 'older patients with hypertension']","['Telmisartan', 'placebo', 'low-dose statins', 'antihypertensive (telmisartan vs. placebo) and lipid-modulating (low-dose rosuvastatin vs. placebo', 'Rosuvastatin', 'hydrochlorothiazide', 'sartans and low-dose statins', 'Brain magnetic resonance imaging (MRI', 'telmisartan', 'rosuvastatin']","['risks of new-incident WMH Fazekas scale scores ≥\u20092 and the incidence of cognitive impairment', 'lower risks of new-incident Fazekas scale scores', 'WMH and cognitive function', 'WMH progression and cognitive function decline', 'cognitive impairment', 'cerebral white matter hyperintensities and cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C1563745', 'cui_str': 'Selective Angiotensin II Receptor Antagonists'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0152295', 'cui_str': 'Cerebral white matter structure'}]",732.0,0.140507,The risks of new-incident WMH Fazekas scale scores ≥ 2 and the incidence of cognitive impairment did not differ between the telmisartan and placebo groups.,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China.'}, {'ForeName': 'Yingxin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Yuanli', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Community, Lanshan District People Hospital, Linyi, Shandong, 276002, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Duan', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Hospital of Shandong University, Jinan, Shandong, 250000, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiology, The Second Hospital of Shandong University, Jinan, Shandong, 250000, China.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Ji', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Shangwen', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'The Russel H Morgan Department of Radiology and Radiological Sciences, The Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chai', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Cardio-Cerebrovascular Control and Research Center, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong, 250062, China. zhendongliu876@126.com.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0165-7']
842,30188798,Effects of Testosterone and Progressive Resistance Exercise on Vascular Function in Older Men.,"The cardiovascular effects of testosterone (T) are controversial. Low T has been associated with accelerated vascular aging, characterized by large elastic artery stiffening (decreased compliance), intimal-medial thickening (IMT), and endothelial dysfunction. Endurance exercise improves vascular function, but resistance training may increase arterial stiffness. We sought to determine whether T supplementation improved markers of vascular aging in men with low-normal T, and whether T supplementation prevented arterial stiffness with resistance exercise. We studied 160 community dwelling older men (66 ± 5 years) with low-normal baseline total T levels (200-350 ng/dL). Participants were randomized to transdermal T gel targeting either a lower [400-550 ng/dL] or higher [600-1000 ng/dL] T range or to placebo gel, and to either progressive resistance training (PRT) or to no exercise for 12 months. Carotid artery stiffness (arterial compliance) and carotid IMT were measured at baseline, 6, and 12 months. Endothelial function (brachial artery flow-mediated dilation) was measured in a subset (N=86). Changes in carotid artery compliance, IMT and endothelial function with either the lower or higher range of T supplementation were not different from placebo at 6 or 12 months. There were no differences between PRT and no PRT groups, alone or with T supplementation, in changes in any of the vascular measures at either time point. Supplementation of T and PRT in older men with low-normal levels do not appear to improve or harm vascular function.",2018,Supplementation of T and PRT in older men with low-normal levels do not appear to improve or harm vascular function.,"['Older Men', 'older men with low-normal levels', 'men with low-normal T, and whether T supplementation prevented arterial stiffness with resistance exercise', '160 community dwelling older men (66 ± 5 years) with low-normal baseline total T levels (200-350 ng/dL']","['T supplementation', 'placebo', 'transdermal T gel targeting either a lower [400-550 ng/dL] or higher [600-1000 ng/dL', 'testosterone (T', 'placebo gel', 'progressive resistance training (PRT) or to no exercise', 'Endurance exercise', 'Testosterone and Progressive Resistance Exercise']","['Endothelial function (brachial artery flow-mediated dilation', 'Vascular Function', 'Carotid artery stiffness (arterial compliance) and carotid IMT', 'vascular function', 'carotid artery compliance, IMT and endothelial function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",160.0,0.429495,Supplementation of T and PRT in older men with low-normal levels do not appear to improve or harm vascular function.,"[{'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Hildreth', 'Affiliation': 'Medicine, University of Colorado Anschutz Medical Campus, United States.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Schwartz', 'Affiliation': 'Medicine, Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Vande Griend', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Kohrt', 'Affiliation': 'Division of Geriatric Medicine, University of Colorado - Anschutz Medical Campus, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Blatchford', 'Affiliation': 'Colorado Biostatistical Consortium, Colorado School of Public Health, University of Colorado Anschutz Medical Campus.'}, {'ForeName': 'Kerrie L', 'Initials': 'KL', 'LastName': 'Moreau', 'Affiliation': 'Medicine/Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00165.2018']
843,31856908,Variable- versus constant-frequency deep-brain stimulation in patients with advanced Parkinson's disease: study protocol for a randomized controlled trial.,"BACKGROUND


Deep-brain stimulation targeting the subthalamic nucleus (STN) can be used to treat motor symptoms and dyskinesia in the advanced stages of Parkinson's disease (PD). High-frequency stimulation (HFS) of the STN can lead to consistent, long-term improvement of PD symptoms. However, the effects of HFS on the axial symptoms of PD, specifically freezing of gait, can be limited or cause further impairment. While this can be alleviated via relatively low-frequency stimulation (LFS) in selected patients, LFS does not control all motor symptoms of PD. Recently, the National Engineering Laboratory for Neuromodulation reported preliminary findings regarding an efficient way to combine the advantages of HFS and LFS to form variable-frequency stimulation (VFS). However, this novel therapeutic strategy has not been formally tested in a randomized trial.
METHODS/DESIGN


We propose a multicenter, double-blind clinical trial involving 11 study hospitals and an established deep-brain stimulation team. The participants will be divided into a VFS and a constant-frequency stimulation group. The primary outcome will be changes in stand-walk-sit task scores after 3 months of treatment in the ""medication off"" condition. Secondary outcome measures include specific item scores on the Freezing of Gait Questionnaire and quality of life. The aim of this trial is to investigate the efficacy and safety of VFS compared with constant-frequency stimulation.
DISCUSSION


This is the first randomized controlled trial to comprehensively evaluate the effectiveness and safety of VFS of the STN in patients with advanced PD. VFS may represent a new option for clinical treatment of PD in the future.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03053726. Registered on February 15, 2017.",2019,"High-frequency stimulation (HFS) of the STN can lead to consistent, long-term improvement of PD symptoms.","[""patients with advanced Parkinson's disease"", '11 study hospitals and an established deep-brain stimulation team', 'patients with advanced PD']","['VFS', 'STN', 'Variable- versus constant-frequency deep-brain stimulation', 'HFS']","['efficacy and safety', 'specific item scores on the Freezing of Gait Questionnaire and quality of life', 'changes in stand-walk-sit task scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",11.0,0.287859,"High-frequency stimulation (HFS) of the STN can lead to consistent, long-term improvement of PD symptoms.","[{'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Jia', 'Affiliation': 'National Engineering laboratory for Neuromodulation, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Functional Neurosurgery, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Functional Neurosurgery, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Zhanhua', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Nanjing Brain Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University of Chinese PLA, Xi'an, Shanxi, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Qilu Hospital, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Zhipei', 'Initials': 'Z', 'LastName': 'Ling', 'Affiliation': 'Department of Neurosurgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Department of Neurosurgery, the Second People's Hospital of Shenzhen, Guangzhou, China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, Affiliated with School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Neurosurgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Nanjing Brain Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Luming', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'National Engineering laboratory for Neuromodulation, Tsinghua University, Beijing, China. lilm@tsinghua.edu.cn.'}]",Trials,['10.1186/s13063-019-3884-4']
844,30380038,A Balanced Proinflammatory and Regulatory Cytokine Signature in Young African Children Is Associated With Lower Risk of Clinical Malaria.,"BACKGROUND


The effect of timing of exposure to first Plasmodium falciparum infections during early childhood on the induction of innate and adaptive cytokine responses and their contribution to the development of clinical malaria immunity is not well established.
METHODS


As part of a double-blind, randomized, placebo-controlled trial in Mozambique using monthly chemoprophylaxis with sulfadoxine-pyrimethamine plus artesunate to selectively control timing of malaria exposure during infancy, peripheral blood mononuclear cells collected from participants at age 2.5, 5.5, 10.5, 15, and 24 months were stimulated ex vivo with parasite schizont and erythrocyte lysates. Cytokine messenger RNA expressed in cell pellets and proteins secreted in supernatants were quantified by reverse-transcription quantitative polymerase chain reaction and multiplex flow cytometry, respectively. Children were followed up for clinical malaria from birth until 4 years of age.
RESULTS


Higher proinflammatory (interleukin [IL] 1, IL-6, tumor necrosis factor) and regulatory (IL-10) cytokine concentrations during the second year of life were associated with reduced incidence of clinical malaria up to 4 years of age, adjusting by chemoprophylaxis and prior malaria exposure. Significantly lower concentrations of antigen-specific T-helper 1 (IL-2, IL-12, interferon-γ) and T-helper 2 (IL-4, IL-5) cytokines by 2 years of age were measured in children undergoing chemoprophylaxis compared to children receiving placebo (P < .03).
CONCLUSIONS


Selective chemoprophylaxis altering early natural exposure to malaria blood stage antigens during infancy had a significant effect on T-helper lymphocyte cytokine production >1 year later. Importantly, a balanced proinflammatory and anti-inflammatory cytokine signature, probably by innate cells, around age 2 years was associated with protective clinical immunity during childhood.
CLINICAL TRIALS REGISTRATION


NCT00231452.",2019,"Significantly lower concentrations of antigen-specific TH1 (IL-2, IL-12, IFN-) and TH2 (IL-4, IL-5) cytokines by 2 years of age were measured in children under chemoprophylaxis compared to children receiving placebo (p<0.03).
","['malaria exposure during infancy, peripheral blood mononuclear cells collected at ages 2.5, 5.5, 10.5, 15 and 24 months were stimulated ex vivo with parasite schizont and erythrocyte lysates', 'young African children']","['sulfadoxine-pyrimethamine plus artesunate', 'placebo']","['concentrations of antigen-specific TH1 (IL-2, IL-12, IFN-\uf067) and TH2 (IL-4, IL-5) cytokines', 'TH lymphocyte cytokine production', 'pro-inflammatory (IL-1, IL-6, TNF) and regulatory (IL-10) cytokine concentrations']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521066', 'cui_str': 'parasites'}, {'cui': 'C0562656', 'cui_str': 'Schizonts'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0033268'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.290244,"Significantly lower concentrations of antigen-specific TH1 (IL-2, IL-12, IFN-) and TH2 (IL-4, IL-5) cytokines by 2 years of age were measured in children under chemoprophylaxis compared to children receiving placebo (p<0.03).
","[{'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique.'}, {'ForeName': 'Maria N', 'Initials': 'MN', 'LastName': 'Manaca', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Berthoud', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Llorenç', 'Initials': 'L', 'LastName': 'Quintó', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Arnoldo', 'Initials': 'A', 'LastName': 'Barbosa', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Mauricio H', 'Initials': 'MH', 'LastName': 'Rodríguez', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Penny L', 'Initials': 'PL', 'LastName': 'Groves', 'Affiliation': 'Institució Catalana de Recerca i Estudis Avançats, Barcelona, Spain.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Santano', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Quique', 'Initials': 'Q', 'LastName': 'Bassat', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Aponte', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Guinovart', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}, {'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Doolan', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Alonso', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Catalonia, Spain.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy934']
845,31454502,"Comparison of the Anesthetic Efficiency of Lidocaine and Tramadol Hydrochloride in Orthodontic Extractions: A Split-Mouth, Prospective, Randomized, Double-Blind Study.","PURPOSE


The aim of the present randomized controlled split-mouth clinical study was to evaluate and compare the clinical anesthetic efficacy of lidocaine and tramadol hydrochloride in orthodontic extractions.
MATERIALS AND METHODS


A total of 32 systemically healthy patients requiring bilaterally maxillary first premolar extractions for orthodontic reasons were included. Each patient received 1.8 mL of lidocaine (36 mg lidocaine HCI and 0.0225 mg epinephrine) on 1 side and 1.8 mL tramadol (50 mg tramadol HCl and 0.0225 mg epinephrine diluted to 1.8 mL by distilled water) on the other side. The anesthetic solutions were infiltrated into the buccal vestibule (local infiltration) based on a computer-generated list. In each patient, the time of anesthetic onset and finish, anesthetic activity, duration of postoperative analgesia, additional analgesic medication, wound healing, possible side effects, and satisfaction levels were recorded intraoperatively and postoperatively for both sides.
RESULTS


Although no relevant differences were found between the solutions for anesthetic onset, lidocaine was significantly more effective statistically for the total anesthesia duration. Comparing the anesthetic activity at 5 minutes before extraction, we found that tramadol was significantly more effective statistically compared with lidocaine. Similarly, tramadol was significantly more effective statistically than lidocaine for satisfaction level and wound healing. Moreover, compared with tramadol, in terms of postoperative pain, the visual analog scale scores with lidocaine were significantly higher at statistically 7, 8, 9, and 10 hours during the first 12 hours. In general, the lidocaine values were dramatically higher than were the tramadol values.
CONCLUSIONS


The results of the present study suggest that using tramadol combined with epinephrine can be an alternative local anesthetic for maxillary first premolar tooth extractions in oral-maxillofacial surgery.",2020,"Although no relevant differences were found between the solutions for anesthetic onset, lidocaine was significantly more effective statistically for the total anesthesia duration.","['32 systemically healthy patients requiring bilaterally maxillary first premolar extractions for orthodontic reasons were included', 'Orthodontic Extractions']","['tramadol HCl', 'tramadol combined with epinephrine', 'Lidocaine and Tramadol Hydrochloride', 'epinephrine', 'tramadol', 'lidocaine HCI and 0.0225\xa0mg epinephrine', 'lidocaine and tramadol hydrochloride', 'lidocaine']","['postoperative pain, the visual analog scale scores', 'satisfaction level and wound healing', 'time of anesthetic onset and finish, anesthetic activity, duration of postoperative analgesia, additional analgesic medication, wound healing, possible side effects, and satisfaction levels', 'anesthetic activity', 'clinical anesthetic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C2350089', 'cui_str': 'tramadol hydrochloride'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.133189,"Although no relevant differences were found between the solutions for anesthetic onset, lidocaine was significantly more effective statistically for the total anesthesia duration.","[{'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Ege', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey.'}, {'ForeName': 'Miray', 'Initials': 'M', 'LastName': 'Ege', 'Affiliation': 'Teaching Assistant, Department of Pharmacognosy, Faculty of Pharmacy, Adıyaman University, Adıyaman, Turkey. Electronic address: miregein@gmail.com.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Koparal', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Alan', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Inonu University, Malatya, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.07.010']
846,30296920,Efficacy of dry needling in patients with myofascial temporomandibular disorders related to the masseter muscle.,"OBJECTIVE


This randomized, single-center clinical trial aimed to compare the efficacy of superficial dry needling (SDN) and deep dry needling (DDN) in patients with myofascial temporomandibular disorder (MTMD) related to the masseter muscle. Methods : Forty patients showing MTMD with trigger points in the masseter muscle were randomly assigned to groups. Dry needling of the masseter muscle was performed once per week for three weeks. Pressure pain threshold (PPT) measurements, visual analog scale scores, and maximal jaw opening were assessed. Results : Both patient groups showed significant pain reduction, but the SDN group showed significantly better pain reduction. The PPT measurements obtained in the follow-up examinations at three and six weeks were significantly better than the values in SDN and DDN groups. Discussion : SDN showed better pain-reduction efficacy in patients with MTMD. Further research with a larger size sample and a longer follow-up period will help elucidate the benefits of SDN.",2020,"The PPT measurements obtained in the follow-up examinations at three and six weeks were significantly better than the values in SDN and DDN groups.
","['patients with myofascial temporomandibular disorder (MTMD', 'Forty patients showing MTMD with trigger points in the masseter muscle', 'patients with MTMD', 'patients with myofascial temporomandibular disorders related to the masseter muscle']","['superficial dry needling (SDN) and deep dry needling (DDN', 'dry needling']","['pain reduction', 'Pressure pain threshold (PPT) measurements, visual analog scale scores, and maximal jaw opening', 'pain-reduction efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0024876', 'cui_str': 'Masseter Muscle'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",40.0,0.0556821,"The PPT measurements obtained in the follow-up examinations at three and six weeks were significantly better than the values in SDN and DDN groups.
","[{'ForeName': 'Mehmet Cem', 'Initials': 'MC', 'LastName': 'Özden', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}, {'ForeName': 'Berkem', 'Initials': 'B', 'LastName': 'Atalay', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}, {'ForeName': 'Ali Veysel', 'Initials': 'AV', 'LastName': 'Özden', 'Affiliation': 'Department of Physiotherapy, Rehabilitation, Health Sciences Institute, Bahçeşehir University , İstanbul, Turkey.'}, {'ForeName': 'Abdülkadir', 'Initials': 'A', 'LastName': 'Çankaya', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}, {'ForeName': 'Erdinç', 'Initials': 'E', 'LastName': 'Kolay', 'Affiliation': 'Department of Statistics, Faculty of Science, Sinop University , Sinop, Turkey.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Istanbul University , Istanbul, Turkey.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2018.1526848']
847,30261805,Telementoring for improving primary care provider knowledge and competence in managing chronic pain: A randomised controlled trial.,"Introduction


Primary care providers are frequently unprepared to manage chronic pain adequately due in part to insufficient professional training. This study evaluated the effect of a telementoring intervention on knowledge and perceived competence related to chronic pain management.
Methods


The study design was a cluster randomised controlled trial. Primary care clinics that were part of the University of Washington Medicine Telehealth network were the unit of randomization. Primary care providers comprised the intervention group (n = 23) and the control group (n = 18). Providers in the intervention group attended telementoring sessions through the TelePain programme and presented patient cases at the beginning and end of their enrolled patients’ 12-week study period. TelePain sessions included a didactic presentation and telementoring for specific patient cases by a panel of pain specialists from the disciplines of pain medicine, internal medicine, anaesthesiology, rehabilitation medicine, psychiatry, addiction medicine, nursing and complementary and integrative pain management. Providers’ baseline and end-of-study knowledge and perceived competence in managing chronic pain were assessed by three questionnaires: Knowledge and Attitudes Survey Regarding Pain, the KnowPain-12 and the Perceived Competence Scale.
Results


Knowledge (Z = –0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = –0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group. These providers attended on average 12.5 sessions (range 0–31) while participating in the study.
Discussion


Further research is recommended to establish the effectiveness of this telementoring intervention.",2020,"Results Knowledge (Z = -0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = -0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group.","['Primary care clinics that were part of the University of Washington Medicine Telehealth network were the unit of randomization', 'managing chronic pain']","['TelePain programme', 'telementoring intervention', 'TelePain sessions']",[],"[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",[],[],,0.181327,"Results Knowledge (Z = -0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = -0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group.","[{'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Eaton', 'Affiliation': 'School of Nursing and Health Studies, University of Washington Bothell, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Godfrey', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Dale J', 'Initials': 'DJ', 'LastName': 'Langford', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rue', 'Affiliation': 'School of Nursing, University of Washington Seattle, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Tauben', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Ardith Z', 'Initials': 'AZ', 'LastName': 'Doorenbos', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18802978']
848,31931647,"Cost-effectiveness analysis of rituximab with methotrexate, cytarabine and thiotepa for the treatment of patients with primary central nervous system lymphoma.","The International Extranodal Lymphoma Study Group-32 (IELSG32) randomized patients with primary central nervous system lymphoma (PCNSL) for induction treatment with methotrexate-cytarabine, methotrexate-cytarabine-rituximab, or methotrexate-cytarabine-thiotepa-rituximab (MATRix) and reported significantly improved complete remission with the MATRix regimen. This study assessed cost-effectiveness among these three induction strategies for PCNSL. A Markov model was developed based on the IELSG32 trial over a 20 year time horizon from the Canadian health care system perspective. Costs for induction, consolidation, inpatient treatment administration, follow-up, adverse events, relapsed disease, and palliative care were included. Methotrexate-cytarabine-rituximab was subject to extended dominance by the other two strategies. The MATRix regimen compared to methotrexate-cytarabine produced 3.05 quality-adjusted life year (QALY) gains at added costs of $75,513, resulting in an incremental cost-effectiveness ratio of $24,758/QALY gained. The MATRix regimen was the optimal strategy in the majority of simulations (98% probability at willingness-to-pay of $50,000/QALY gained) and results appeared robust across sensitivity analyses.",2020,"The MATRix regimen compared to methotrexate-cytarabine produced 3.05 quality-adjusted life year (QALY) gains at added costs of $75,513, resulting in an incremental cost-effectiveness ratio of $24,758/QALY gained.","['patients with primary central nervous system lymphoma', 'patients with primary central nervous system lymphoma (PCNSL']","['rituximab with methotrexate, cytarabine and thiotepa', 'methotrexate-cytarabine, methotrexate-cytarabine-rituximab, or methotrexate-cytarabine-thiotepa-rituximab (MATRix', 'Methotrexate-cytarabine-rituximab', 'methotrexate-cytarabine']","['quality-adjusted life year (QALY) gains', 'incremental cost-effectiveness ratio', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280803', 'cui_str': 'Primary central nervous system lymphoma'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0039871', 'cui_str': 'Thiotepa'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0210628,"The MATRix regimen compared to methotrexate-cytarabine produced 3.05 quality-adjusted life year (QALY) gains at added costs of $75,513, resulting in an incremental cost-effectiveness ratio of $24,758/QALY gained.","[{'ForeName': 'Jaclyn M', 'Initials': 'JM', 'LastName': 'Beca', 'Affiliation': 'Pharmacoeconomics Research Unit, Cancer Care Ontario, Toronto, Canada.'}, {'ForeName': 'Kaiwan', 'Initials': 'K', 'LastName': 'Raza', 'Affiliation': 'Pharmacoeconomics Research Unit, Cancer Care Ontario, Toronto, Canada.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Mow', 'Affiliation': 'Provincial Drug Reimbursement Programs, Cancer Care Ontario, Toronto, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Keech', 'Affiliation': 'Provincial Drug Reimbursement Programs, Cancer Care Ontario, Toronto, Canada.'}, {'ForeName': 'C Tom', 'Initials': 'CT', 'LastName': 'Kouroukis', 'Affiliation': 'Provincial Drug Reimbursement Programs, Cancer Care Ontario, Toronto, Canada.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1711902']
849,30172263,[Clinical Value of Four-hole Unilateral Dissecting Lobectomy and Mediastinal Lymph Node Dissection in the Treatment of Early Non-small Cell Lung Cancer].,"BACKGROUND


Thoracoscopic lobectomy combined with mediastinal lymph node dissection has been considered as one of the standard surgical procedures for early lung cancer. After 20 years of development, thoracoscopic lobectomy has reached a consensus on reliability and minimally invasive. At present, thoracoscopic lobectomy has a variety of incisions, which gradually evolve into four holes based on three holes, and two or one hole as the operative approach. The aim of this study was to evaluate the clinical value of four-hole unilateral dissecting lobectomy and mediastinal lymph node dissection in the treatment of non-small cell lung cancer (NSCLC). The aim of this study was to investigate the clinical value of anatomical lobectomy with mediastinal lymphadenectomy under four-hole completely video-assisted thoracoscopic surgery (C-VATS) in the treatment of non-small cell lung cancer.
METHODS


The patients undergoing lobectomy with mediastinal lymphadenectomy for NSCLC were identified in the Department of Thoracic Surgery, Yangzhou First People's Hospital, Yangzhou University from March 2015 to July 2016. Preoperative clinical diagnosis of peripheral-type early NSCLC. The patients were randomly divided into four-hole monophasic group (experimental group) and three-hole group (control group) according to the number of hospitalization before surgery. According to inclusion and exclusion criteria, the 39 cases assign in experimental group and 34 cases in the control group, including 36 males and 37 females; aged 38 to 84 years. The mean operation time, average blood loss, lymph node dissection group, average drainage, average extubation time and postoperative complications were compared between the two groups for statistical analysis.
RESULTS


The two groups of patients were successfully completed surgery, no death after surgery. Mean bleeding in the two groups, the number of lymph node dissection group, the average postoperative drainage, the average time of extubation, postoperative complications, with no significant difference. The average operation time of the four-hole unidirectional group was shorter than that of the three-hole group. The difference was statistically significant (P<0.05).
CONCLUSIONS


The safety and efficacy of a four-hole one-way operation under VATS are satisfactory. The operation is smooth during operation, which shortens the course of operation and deserves the clinical promotion.
.",2018,"The mean operation time, average blood loss, lymph node dissection group, average drainage, average extubation time and postoperative complications were compared between the two groups for statistical analysis.
","['39 cases assign in experimental group and 34 cases in the control group, including 36 males and 37 females; aged 38 to 84 years', 'non-small cell lung cancer', ""patients undergoing lobectomy with mediastinal lymphadenectomy for NSCLC were identified in the Department of Thoracic Surgery, Yangzhou First People's Hospital, Yangzhou University from March 2015 to July 2016"", 'non-small cell lung cancer (NSCLC']","['Thoracoscopic lobectomy combined with mediastinal lymph node dissection', 'Four-hole Unilateral Dissecting Lobectomy and Mediastinal Lymph Node Dissection', 'anatomical lobectomy with mediastinal lymphadenectomy under four-hole completely video-assisted thoracoscopic surgery (C-VATS', 'hole unilateral dissecting lobectomy and mediastinal lymph node dissection', 'thoracoscopic lobectomy', 'hole monophasic group (experimental group) and three-hole group (control group']","['safety and efficacy', 'Mean bleeding', 'average postoperative drainage, the average time of extubation, postoperative complications', 'mean operation time, average blood loss, lymph node dissection group, average drainage, average extubation time and postoperative complications', 'average operation time']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0205186', 'cui_str': 'Monophasic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",,0.0227909,"The mean operation time, average blood loss, lymph node dissection group, average drainage, average extubation time and postoperative complications were compared between the two groups for statistical analysis.
","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Thoracic Surgery, Affiliated to Hospital of Yangzhou University, Yangzhou 225000, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Diao', 'Affiliation': 'Department of Thoracic Surgery, Affiliated to Hospital of Yangzhou University, Yangzhou 225000, China.'}, {'ForeName': 'Huangxin', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Thoracic Surgery, Affiliated to Hospital of Yangzhou University, Yangzhou 225000, China.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Thoracic Surgery, Affiliated to Hospital of Shanghai Jiao Tong University, Shanghai 200240, China.'}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2018.08.02']
850,30418101,A Randomized Controlled Trial Comparing Telehealth Self-Management to Standard Outpatient Management in Underserved Black and Hispanic Patients Living with Heart Failure.,"Background:   Although the American Heart Association promotes telehealth models to improve care access, there is limited literature on its use in underserved populations. This study is the first to compare utilization and quality of life (QoL) for underserved black and Hispanic heart failure (HF) patients assigned to telehealth self-monitoring (TSM) or comprehensive outpatient management (COM) over 90 days.   Methods:   This randomized controlled trial enrolled 104 patients. Outcomes included emergency department (ED) visits, hospitalizations, QoL, depression, and anxiety. Binary outcomes for utilization were analyzed using chi-square or Fisher's exact test. Poisson or negative binomial regression, repeated-measures analysis of variance, or generalized estimating equations were also used as appropriate.   Results:   Of 104 patients, 31% were Hispanic, 69% black, 41% women, and 72% reported incomes of <$10,000/year. Groups did not differ regarding binary ED visits (relative risk [RR] = 1.37, confidence interval [CI] = 0.83-2.27), hospitalization (RR = 0.92, CI = 0.57-1.48), or length of stay in days (TSM = 0.54 vs. COM = 0.91). Number of all-cause hospitalizations was significantly lower for COM (TSM = 0.78 vs. COM = 0.55;  p  = 0.03). COM patients reported greater anxiety reduction from baseline to 90 days (TSM = 50-28%; COM = 57-13%;  p  = 0.05).   Conclusions:   These findings suggest that TSM is not effective in reducing utilization or improving QoL for underserved patients with HF. Future studies are needed to determine whether TSM can be effective for populations facing health care access issues.",2019,"COM patients reported greater anxiety reduction from baseline to 90 days (TSM = 50-28%; COM = 57-13%; p = 0.05).
","['104 patients', 'underserved patients with HF', 'Underserved Black and Hispanic Patients Living with Heart Failure', 'underserved black and Hispanic heart failure (HF) patients assigned to']","['COM', 'telehealth self-monitoring (TSM) or comprehensive outpatient management (COM', 'Telehealth Self-Management to Standard Outpatient Management', 'TSM']","['utilization and quality of life (QoL', 'Number of all-cause hospitalizations', 'anxiety reduction', 'length of stay', 'binary ED visits', 'hospitalization', 'emergency department (ED) visits, hospitalizations, QoL, depression, and anxiety']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",104.0,0.0954113,"COM patients reported greater anxiety reduction from baseline to 90 days (TSM = 50-28%; COM = 57-13%; p = 0.05).
","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Pekmezaris', 'Affiliation': 'Department of Medicine, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Christian N', 'Initials': 'CN', 'LastName': 'Nouryan', 'Affiliation': 'Department of Medicine, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Department of Occupational Medicine Epidemiology and Prevention, Northwell Health, Great Neck, New York.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Castillo', 'Affiliation': 'Department of Cardiology, Heart Failure Center, Nassau University Medical Center, East Meadow, New York.'}, {'ForeName': 'Amgad N', 'Initials': 'AN', 'LastName': 'Makaryus', 'Affiliation': 'Department of Medicine, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ahern', 'Affiliation': 'Department of Cardiology, Heart Failure Center, Nassau University Medical Center, East Meadow, New York.'}, {'ForeName': 'Meredith B', 'Initials': 'MB', 'LastName': 'Akerman', 'Affiliation': 'Department of Biostatistics, The Feinstein Institute of Medical Research, Manhasset, New York.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Lesser', 'Affiliation': 'Department of Medicine, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': 'Department of Cardiology, Heart Failure Center, Nassau University Medical Center, East Meadow, New York.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Community Advisory Board, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Pecinka', 'Affiliation': 'Nursing Department, Queensborough Community College, Bayside, New York.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Zeltser', 'Affiliation': 'Department of Medicine, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'DiMarzio', 'Affiliation': 'Department of Medicine, Northwell Health, Manhasset, New York.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0219']
851,30293208,Effect of Synbiotic and Probiotic Supplementation on Serum Levels of Endothelial Cell Adhesion Molecules in Hemodialysis Patients: a Randomized Control Study.,"The aim of this study was to investigate the effect of synbiotic and probiotic supplementation on serum vascular dysfunction and necrosis markers in hemodialysis (HD) patients. In this randomized, double-blind, placebo-controlled trial, 75 HD patients were randomly assigned to either the synbiotic or probiotic or placebo group. The patients in the synbiotic group received 15 g of prebiotics and 5 g probiotic powder containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Bifidobacterium bifidum strain BIA-6, Bifidobacterium lactis strain BIA-6, Bifidobacterium longum strain LAF-5 (2.7 × 10 7  CFU/g each) in sachets (n = 25), whereas the probiotic group received 5 g probiotics same to the first group with 15 g of maltodextrin powder in sachets (n = 25) and the placebo group received 20 g of maltodextrin powder in sachets (n = 25) for 12 weeks. At baseline and the end of the study, serum concentrations of soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), cytokeratin 18 (CK-18) as the necrosis marker, uric acid, and phosphate levels were measured. Feces also were collected for microbiota colony counting. Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03). Serum levels of VCAM-1 and CK-18 were not significantly different between the groups. However, the reduction in serum levels of VCAM-1 in the synbiotic group was significantly higher in comparison to the placebo group (P = 0.01). Multivariate linear regression analysis revealed that ∆ phosphate was the sole independent determinant of ∆ICAM-1 (P = 0 < 001). The study indicated that synbiotic supplementation reduced serum ICAM-1 level, which is a risk factor for cardiovascular diseases in HD patients, but has no effect on the necrosis marker. Trial registration: www.irct.ir (IRCT2017041233393N1).",2019,"Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03).","['hemodialysis (HD) patients', '75 HD patients', 'HD patients', 'Hemodialysis Patients']","['placebo group received 20\xa0g of maltodextrin powder in sachets', 'placebo', 'maltodextrin powder in sachets', 'synbiotic and probiotic supplementation', 'synbiotic or probiotic or placebo', 'synbiotic supplementation', '15\xa0g of prebiotics and 5\xa0g probiotic powder containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Bifidobacterium bifidum strain BIA-6, Bifidobacterium lactis strain BIA-6, Bifidobacterium longum strain LAF-5', 'Synbiotic and Probiotic Supplementation']","['Serum levels of VCAM-1 and CK-18', 'serum levels of VCAM-1', 'Serum ICAM-1 level', 'serum vascular dysfunction and necrosis markers', 'serum ICAM-1 level', 'serum concentrations of soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), cytokeratin 18 (CK-18) as the necrosis marker, uric acid, and phosphate levels', 'Serum Levels of Endothelial Cell Adhesion Molecules']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",75.0,0.220696,"Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03).","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Haghighat', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. shahi334@gmail.com.'}, {'ForeName': 'Shokouh', 'Initials': 'S', 'LastName': 'Shayanpour', 'Affiliation': 'Department of Nephrology, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9477-9']
852,30001288,A Randomized Controlled Trial Comparing Colonoscopic Enema With Additional Oral Preparation as a Salvage for Inadequate Bowel Cleansing Before Colonoscopy.,"GOALS


The goal of this study was to evaluate the noninferiority of colonoscopic enema to additional oral preparation in salvage bowel cleansing for inadequate preparation for a morning colonoscopy.
BACKGROUND


Colonoscopic enema, administering additional cathartics into the right colon through the colonoscope accessory channel, is suggested to rescue poor bowel preparation for a colonoscopy but lacking comparative study.
STUDY


In this prospective, randomized, actively-controlled, parallel group, noninferiority trial, consecutive outpatients and health checkup recipients aged from 19 to 70 years with inappropriate bowel preparation during an elective colonoscopy were enrolled to receive either a colonoscopic enema of 1 L polyethylene glycol (PEG) (enema group) or additional oral intake of 2 L PEG (oral group). The primary endpoint was the proportion of adequate bowel preparation evaluated using the Boston Bowel Preparation Scale.
RESULTS


Overall, 131 participants were randomized. Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001). The largest difference in the proportion of adequate bowel preparation was observed in the right colon (57.8% in the enema group vs. 86.9% in the oral group; P<0.001), followed by the transverse colon (85.9% vs. 98.4%; P=0.017) and the left colon (90.6% vs. 96.7%; P=0.274).
CONCLUSIONS


The colonoscopic enema of 1 L PEG was inferior to the additional oral ingestion of 2 L PEG regarding efficacy as a salvage bowel preparation in adults with inadequate bowel cleansing for colonoscopy.",2019,"Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001).","['adults with inadequate bowel cleansing for colonoscopy', 'consecutive outpatients and health checkup recipients aged from 19 to 70 years with inappropriate bowel preparation during an elective colonoscopy were enrolled to receive either a', '131 participants were randomized']",['colonoscopic enema of 1\u2009L polyethylene glycol (PEG) (enema group) or additional oral intake of 2\u2009L PEG (oral group'],"['proportion of adequate bowel preparation', 'left colon', 'right colon', 'Adequate bowel preparation', 'proportion of adequate bowel preparation evaluated using the Boston Bowel Preparation Scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0014268', 'cui_str': 'Enematas'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0227388', 'cui_str': 'Left colon structure'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}]",131.0,0.120439,"Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001).","[{'ForeName': 'Hyo-Joon', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology.'}, {'ForeName': 'Dong Il', 'Initials': 'DI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology.'}, {'ForeName': 'Soo-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology.'}, {'ForeName': 'Sunyong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Total Healthcare Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'Taeheon', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Total Healthcare Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'Yunho', 'Initials': 'Y', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Soonchunhyang University College of Medicine, Cheonan.'}, {'ForeName': 'Chang Soo', 'Initials': 'CS', 'LastName': 'Eun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001087']
853,31647564,Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial.,"INTRODUCTION


Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone.
METHODS


We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3-5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day.
RESULTS


Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%-12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction.
CONCLUSIONS


Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit.
IMPLICATIONS


A disseminable texting program helped some pregnant women quit smoking.Clinical Trial Registration number: NCT01995097.",2020,SGR did not add significantly to helping women quit or reduce.,"['pregnant women quit smoking', 'Pregnant Smokers', '314 pregnant women from 14 prenatal clinics']","['Texting Program', 'SMS text-delivered scheduled gradual reduction (SGR) program plus support texts']","['7-day point prevalence abstinence at late pregnancy', 'reduction in cigarettes per day', 'quit rates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]",314.0,0.068689,SGR did not add significantly to helping women quit or reduce.,"[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lyna', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bejarano Hernandez', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Subudhi', 'Affiliation': 'Doctor of Medicine Program, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, DUMC 3083, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz174']
854,30227718,Effect of a participatory patient education programme ( NE xt  ED ucation) in group-based patient education among Danes with type 2 diabetes.,"OBJECTIVE


To assess the effect of a participatory group-based education programme for individuals with type 2 diabetes, Next Education.
METHOD


In a quasi-experimental study, individuals with type 2 diabetes were recruited from 14 Danish municipalities with a patient education programme. Eight municipalities using Next Education were intervention sites; six control sites used usual group-based education programmes. Data were collected through questionnaires at baseline and at 3 and 12 months after programmes ended. Changes in quality of life (EQ-5D-5L), diabetes-related emotional distress (PAID-5), physical activity, diet, foot care and sense of coherence (SOC-13) were assessed in generalised linear mixed models.
RESULTS


At baseline, 310 participants (52.6% females, mean age 62.5 years [SD = 10.7] and a mean duration of type 2 diabetes of 6.9 years [SD = 8.4]) participated in Next Education ( n  = 234) or group-based education ( n  = 76) at control sites. Compared with participants at control sites, participants at intervention sites had significantly larger sense of coherence scores at 3 (9.4%,  p  = 0.03) and 12 (9.8%,  p  = 0.02) months of follow-up. Other measures did not differ significantly between groups.
DISCUSSION


It is likely that person-centeredness and high degrees of user participation at the intervention sites improved sense of coherence among Danes with type 2 diabetes.",2020,Other measures did not differ significantly between groups.,"['individuals with type 2 diabetes, Next Education', 'group-based patient education among Danes with type 2 diabetes', 'individuals with type 2 diabetes were recruited from 14 Danish municipalities with a patient education programme', '310 participants (52.6% females, mean age 62.5 years [SD\u2009=\u200910.7] and a mean duration of type 2 diabetes of 6.9 years [SD\u2009=\u20098.4]) participated in Next Education ( n\u2009=\u2009234) or group-based education ( n\u2009=\u200976) at control sites']","['participatory patient education programme (NExt EDucation', 'participatory group-based education programme', 'control sites used usual group-based education programmes']","['quality of life (EQ-5D-5L), diabetes-related emotional distress (PAID-5), physical activity, diet, foot care and sense of coherence (SOC-13', 'larger sense of coherence scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0337800', 'cui_str': 'Danes (ethnic group)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0600182'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0034380'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C3178983', 'cui_str': 'Salutogeneses'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",310.0,0.0209646,Other measures did not differ significantly between groups.,"[{'ForeName': 'Lea An', 'Initials': 'LA', 'LastName': 'Christoffersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Regitze As', 'Initials': 'RA', 'LastName': 'Pals', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Willaing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Olesen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",Chronic illness,['10.1177/1742395318799843']
855,31677296,A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention.,"AIM


To examine the effect of a family-oriented multidisciplinary intervention programme to curtail weight increase in young children with obesity.
METHODS


Children who weighed more than one kilogram above the 97th percentile for height at the preschool assessment in Oppland County, Norway, were identified. Parents residing in one part of the county were invited to participate in a group-based three-year intervention programme while the rest had no interventions. Body mass index (BMI) and family characteristics at entry and measurements at birth were explanatory variables, and change in BMI standard deviation score (SDS) the outcome measure. For the intervention group, outcome was also related to skinfold thicknesses, waist-to-height ratio and physical ability.
RESULTS


The programme was completed by 31 families in the intervention and 33 in the control group. At entry, the respective median (interquartile) age was 5.83 (0.36) and 5.74 (0.66) years, and the BMI SDS 2.35 (1.06) and 1.95 (0.49), P = .012. The median decrease in BMI SDS was 0.19 in both groups. The decline increased with increasing BMI SDS at entry, but irrespective of group. Social or behavioural factor or other anthropometric measures were not associated with outcome.
CONCLUSION


The intervention programme had no effect on BMI SDS.",2020,"For the intervention group, outcome was also related to skinfold thicknesses, waist-to-height ratio and physical ability.
","['young children with obesity', 'Children who weighed more than one kilogram above the 97 th  percentile for height at the pre-school assessment in Oppland County, Norway, were identified']",['family-oriented multidisciplinary intervention program'],"['skinfold thicknesses, waist-to-height ratio and physical ability', 'Social or behavioural factor or other anthropometric measures', 'Body mass index (BMI) and family characteristics at entry and measurements at birth were explanatory variables, and change in BMI standard deviation score (SDS', 'BMI SDS']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015579', 'cui_str': 'Family Characteristics'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",97.0,0.0279488,"For the intervention group, outcome was also related to skinfold thicknesses, waist-to-height ratio and physical ability.
","[{'ForeName': 'Hilde Mjell', 'Initials': 'HM', 'LastName': 'Donkor', 'Affiliation': 'Department of Paediatrics, Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Jacob Holter', 'Initials': 'JH', 'LastName': 'Grundt', 'Affiliation': 'Department of Paediatrics, Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Petur Benedikt', 'Initials': 'PB', 'LastName': 'Júlíusson', 'Affiliation': 'Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Geir Egil', 'Initials': 'GE', 'LastName': 'Eide', 'Affiliation': 'Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hurum', 'Affiliation': 'Department of Paediatrics, Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bjerknes', 'Affiliation': 'Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Markestad', 'Affiliation': 'Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15080']
856,30068669,Sedation during minimal invasive surfactant therapy: a randomised controlled trial.,"BACKGROUND AND AIMS


Although sedation for endotracheal intubation of infants is widely adopted, there is no consensus whether sedation should be used for minimal invasive surfactant therapy (MIST). We compared, in a randomised controlled setting, the level of stress and comfort of preterm infants during MIST with and without receiving low-dose sedation.
METHODS


Infants between 26 and 36 weeks gestational age were randomised to receive either low-dose sedation (1 mg/kg propofol intravenous) or no premedication during MIST procedure. Standard comfort care was given in both groups, which consisted of administering sucrose in the cheek pouch of the infant and containment. Primary end point was the percentage of infants assessed to be comfortable during the procedure (COMFORTneo-score <14). Secondary parameters included complications of both the MIST procedure and low-dose sedation administration.
RESULTS


In total, 78 infants were randomised and analysed, with a median (IQR) gestational age of 29 +0  (28 +0 -32 +0 ) weeks. The percentage of infants with a COMFORTneo score <14 during MIST was significantly higher in the sedated group (32/42 (76%) vs 8/36 (22%), p<0.001). The incidence of desaturation (SpO 2  <85%) during the procedure was significantly higher in the sedated group (38/42 (91%) vs 25/36 (69%), p=0.023), and infants needed more often nasal intermittent mandatory ventilation during the procedure (39/42 (93%) vs 17/36 (47%), p<0.001). There were no differences in incidence of hypotension, bradycardia, intubation or pneumothoraxes.
CONCLUSION


Low-dose sedation increased comfort during MIST procedure in preterm infants, but the need for transient non-invasive ventilation was increased.
TRIAL REGISTRATION NUMBER


NTR5010, pre-results.",2019,"The incidence of desaturation (SpO 2  <85%) during the procedure was significantly higher in the sedated group (38/42 (91%) vs 25/36 (69%), p=0.023), and infants needed more often nasal intermittent mandatory ventilation during the procedure (39/42 (93%) vs 17/36 (47%), p<0.001).","['Infants between 26 and 36 weeks gestational age', 'preterm infants', '78 infants', 'preterm infants during MIST with and without receiving low-dose sedation']","['minimal invasive surfactant therapy', 'low-dose sedation (1\u2009mg/kg propofol intravenous) or no premedication during MIST procedure']","['incidence of desaturation', 'nasal intermittent mandatory ventilation', 'percentage of infants with a COMFORTneo score <14 during MIST', 'percentage of infants assessed to be comfortable during the procedure (COMFORTneo-score <14', 'incidence of hypotension, bradycardia, intubation or pneumothoraxes', 'complications of both the MIST procedure and low-dose sedation administration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0199454', 'cui_str': 'Inspiration mandatory ventilation therapy, initiation and management (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",78.0,0.239261,"The incidence of desaturation (SpO 2  <85%) during the procedure was significantly higher in the sedated group (38/42 (91%) vs 25/36 (69%), p=0.023), and infants needed more often nasal intermittent mandatory ventilation during the procedure (39/42 (93%) vs 17/36 (47%), p<0.001).","[{'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Lopriore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Henriëtte A', 'Initials': 'HA', 'LastName': 'van Zanten', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ratna N G B', 'Initials': 'RNGB', 'LastName': 'Tan', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Hooper', 'Affiliation': 'The Ritchie Center, MIMR-PHI Institute of Medical Research, Melbourne, Victoria, The Netherlands.'}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2018-315015']
857,31538590,Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial.,"STUDY OBJECTIVES


This secondary analysis characterized sleep patterns for toddlers born preterm and tested effects of docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation on children's caregiver-reported sleep. Exploratory analyses tested whether child sex, birth weight, and caregiver depressive symptomatology were moderators of the treatment effect.
METHODS


Omega Tots was a single-site 180-day randomized (1:1), double-blinded, placebo-controlled trial. Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation, assigned to 180 days of daily 200 mg DHA + 200 mg AA supplementation or placebo (400 mg corn oil), and followed after the trial ended to age 26 to 32 months. Caregivers completed a sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire). Analyses compared changes in sleep between the DHA+AA and placebo groups, controlling for baseline scores. Exploratory post hoc subgroup analyses were conducted.
RESULTS


Eighty-one percent (n tx  = 156; n placebo  = 150) of children had 180-day trial outcome data; 68% (n tx  = 134; n placebo  = 122) had postintervention outcome data. Differences in change between the DHA+AA and placebo groups after 180 days of supplementation were not statistically significant for the entire cohort. Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P = .04; sleep problems odds ratio = 0.36, 95% confidence interval = 0.15, 0.82) and children of depressed caregivers (difference in nocturnal sleep change = 1.07, effect size = 0.65, P = .006; difference in total sleep change = 1.10, effect size = 0.50, P = .04) assigned to the treatment group showed improvements in sleep, compared to placebo.
CONCLUSIONS


Although there is no evidence of an overall effect of DHA+AA supplementation on child sleep, exploratory post hoc analyses identified important subgroups of children born preterm who may benefit. Future research including larger samples is warranted.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01576783.
CITATION


Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic acid and arachidonic acid supplementation and sleep in toddlers born preterm: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2019;15(9):1197-1208.",2019,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","['Male children', 'toddlers born preterm', 'Toddlers Born Preterm', ""Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation"", ""children's caregiver-reported sleep"", 'Eighty-one percent (n tx  = 156; n']","['DHA+AA supplementation', 'docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation', 'Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep', 'placebo', 'DHA + 200 mg AA supplementation or placebo', 'Docosahexaenoic acid and arachidonic acid supplementation']","['total sleep change', ""sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire"", 'child sex, birth weight, and caregiver depressive symptomatology']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",,0.812072,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Pelak', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': 'Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7902']
858,31538598,Eye-Blink Parameters Detect On-Road Track-Driving Impairment Following Severe Sleep Deprivation.,"STUDY OBJECTIVES


Drowsiness leads to 20% of fatal road crashes, while inability to assess drowsiness has hampered drowsiness interventions. This study examined the accuracy of eye-blink parameters for detecting drowsiness related driving impairment in real time.
METHODS


Twelve participants undertook two sessions of 2-hour track-driving in an instrumented vehicle following a normal night's sleep or 32 to 34 hours of extended wake in a randomized crossover design. Eye-blink parameters and lane excursion events were monitored continuously.
RESULTS


Sleep deprivation increased the rates of out-of-lane driving events and early drive terminations. Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score) were also increased following sleep deprivation. A time-on-task (drive duration) effect was evident for out-of-lane events rate and most eye-blink parameters after sleep deprivation. The JDS demonstrated the strongest association with the odds of out-of-lane events in the same minute, whereas measures of blink duration and prolonged eye closure were stronger indicators of risk for out-of-lane events over longer periods of 5 minutes and 15 minutes, respectively. Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
CONCLUSIONS


Eyelid closure parameters are useful tools for monitoring and predicting drowsiness-related driving impairment (out-of-lane events) that could be utilized for monitoring drowsiness and assessing the efficacy of drowsiness interventions.
CLINICAL TRIAL REGISTRATION


This study is registered with the Australian New Zealand Clinical Trial Registry (ANCTR), http://www.anzctr.org.au/TrialSearch.aspx ACTRN12612000102875.
CITATION


Shekari Soleimanloo S, Wilkinson VE, Cori JM,Westlake J, Stevens B, Downey LA, Shiferaw BA, Rajaratnam SMW, Howard ME. Eye-blink parameters detect on-road track-driving impairment following severe sleep deprivation. J Clin Sleep Med. 2019;15(9):1271-1284.",2019,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
",['severe sleep deprivation'],"[""2-hour track-driving in an instrumented vehicle following a normal night's sleep""]","['rates of out-of-lane driving events and early drive terminations', 'blink duration and prolonged eye closure', 'A time-on-task (drive duration) effect', 'Eye-blink parameters and lane excursion events', 'Eye-Blink Parameters Detect', ""Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}]","[{'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1269837', 'cui_str': 'Surgical closure of eye structure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1293738', 'cui_str': 'Eyelid closure'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",12.0,0.019793,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
","[{'ForeName': 'Shamsi', 'Initials': 'S', 'LastName': 'Shekari Soleimanloo', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Wilkinson', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cori', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Westlake', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stevens', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Downey', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Brook A', 'Initials': 'BA', 'LastName': 'Shiferaw', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'School of Psychological Sciences, Monash University, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7918']
859,30431393,The Effects of a Theory-Based Patient Portal e-Learning Program for Older Adults with Chronic Illnesses.,"Introduction:   The high prevalence of chronic illnesses is a serious public health problem in the United States, and more than 70 million older adults have at least one chronic illness. Patient portals (PPs) have an excellent potential to assist older adults in managing chronic illnesses; however, older adults' PP adoption rates have been low. Lack of support for older adults using PPs remains a critical gap in most implementation processes. The main aim of this study was to assess the impact of an older adult friendly Theory-based Patient portal e-Learning Program (T-PeP) on PP knowledge, selected health outcomes (health decision-making self-efficacy [SE] and health communication), PP SE and use, and e-health literacy in older adults.   Materials and Methods:   A two-arm randomized controlled trial was conducted with older adults ( N  = 272) who had chronic conditions. Participants were recruited online, and data were collected at baseline, 3 weeks, and 4 months. The main intervention effects were tested using linear mixed models.   Results:   The average age of participants was 70.0 ± 8.5 years, and 78.3% ( n  = 213) were white. At 3 weeks, the intervention group showed significantly greater improvement than the control group in all outcomes except PP use. At 4 months, the intervention effects decreased, but PP SE remained significant ( p  = 0.015), and the intervention group showed higher frequency of PP use than the control group ( p  = 0.029).   Conclusion:   The study findings showed that the T-PeP was effective in improving selected health and PP usage outcomes. Further studies are needed to test the long-term effects of T-PeP using more diverse samples.",2019,"At 4 months, the intervention effects decreased, but PP SE remained significant (p = 0.015), and the intervention group showed higher frequency of PP use than the control group (p = 0.029).
","['70 million older adults', 'Older Adults with Chronic Illnesses', 'older adults (N\u2009=\u2009272) who had chronic conditions', 'The average age of participants was 70.0\u2009±\u20098.5 years, and 78.3% (n\u2009=\u2009213) were white', 'older adults']","['older adult friendly Theory-based Patient portal e-Learning Program (T-PeP', 'Theory-Based Patient Portal e-Learning Program']","['PP SE', 'frequency of PP use']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0581849,"At 4 months, the intervention effects decreased, but PP SE remained significant (p = 0.015), and the intervention group showed higher frequency of PP use than the control group (p = 0.029).
","[{'ForeName': 'Eun-Shim', 'Initials': 'ES', 'LastName': 'Nahm', 'Affiliation': 'Department of Organizational Systems and Adult Health, University of Maryland School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Organizational Systems and Adult Health, University of Maryland School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bellantoni', 'Affiliation': 'Division of Geriatric Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Keldsen', 'Affiliation': 'Veterans Health Education, Nursing Affiliations & My HealtheVet, VA Maryland Health Care System, Baltimore, Maryland.'}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Russomanno', 'Affiliation': 'eHealth Initiatives, University of Maryland Medical System, Baltimore, Maryland.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Rietschel', 'Affiliation': 'Department of Organizational Systems and Adult Health, University of Maryland School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Tabassum', 'Initials': 'T', 'LastName': 'Majid', 'Affiliation': 'Integrace Institute, Sykesville, Maryland.'}, {'ForeName': 'HyoJin', 'Initials': 'H', 'LastName': 'Son', 'Affiliation': 'Department of Organizational Systems and Adult Health, University of Maryland School of Nursing, Baltimore, Maryland.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'SeniorNet, Ft Myers, Florida.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0184']
860,31560794,Effects of a toothpaste containing 0.3% triclosan on periodontal parameters of subjects enrolled in a regular maintenance program: A secondary analysis of a 2-year randomized clinical trial.,"BACKGROUND


The triclosan-containing dentifrices are effective in controlling biofilm formation and maintaining gingival health; however, there is limited information on their effects during the periodontal maintenance phase. Therefore, the aim of this study was to evaluate the clinical effects of a toothpaste containing 0.3% triclosan on the periodontal parameters of subjects that have been treated for peri-implantitis and were enrolled in a regular maintenance program.
METHODS


Subjects presenting at least one implant with peri-implantitis and received surgical anti-infective therapy were selected. Sixty days post-surgery (baseline), subjects were randomized into two groups: (1) toothpaste containing 0.3% triclosan + 2.0% PVM/MA copolymer + 1450 ppm fluoride (test) or (2) toothpaste containing 1450 ppm fluoride (control), and were instructed to brush with the assigned toothpaste twice/day for 2 years. They received clinical monitoring at baseline, 3, 6, 12, 18, and 24 months, and professional maintenance every 3 months.
RESULTS


Eighty-eight subjects with natural teeth were enrolled in the study (Test, n = 39; Control, n = 49). The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (P < 0.05). The mean percentage of sites with probing depth ≥5 mm was reduced over the course of the study only in the test group (P < 0.05).
CONCLUSION


A toothpaste containing 0.3% triclosan was more effective than a regular fluoride toothpaste in improving the periodontal clinical condition around natural teeth of periodontally healthy subjects enrolled in a regular maintenance program for 2 years.",2020,The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (p<0.05).,"['periodontally healthy subjects enrolled in a regular maintenance program for 2 years', 'subjects enrolled in a regular maintenance program', 'Subjects presenting at least one implant with peri-implantitis and received surgical anti-infective therapy were selected', 'Eighty-eight subjects with natural teeth were enrolled in the study (Test, n: 39; Control, n:49', 'subjects that have been treated for peri-implantitis and were enrolled in a regular maintenance program']","['toothpaste containing 0.3% triclosan', 'regular fluoride toothpaste', 'i)toothpaste containing 0.3% triclosan+2.0% PVM/MA copolymer (Gantrez™)+1450 ppm fluoride (test) or (ii)toothpaste containing 1450 ppm fluoride (control']","['periodontal clinical condition', 'levels of plaque', 'percentage of sites exhibiting bleeding', 'periodontal parameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1141958', 'cui_str': 'Anti-infective therapy'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0596383', 'cui_str': 'Copolymer'}, {'cui': 'C0118823', 'cui_str': 'Gantrez'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",88.0,0.0368354,The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (p<0.05).,"[{'ForeName': 'Bernal', 'Initials': 'B', 'LastName': 'Stewart', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Jamil Awad', 'Initials': 'JA', 'LastName': 'Shibli', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Araujo', 'Affiliation': 'School of Dentistry, Maringa University, Maringa, Paraná, Brazil.'}, {'ForeName': 'Luciene Cristina', 'Initials': 'LC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Fotinos', 'Initials': 'F', 'LastName': 'Panagakos', 'Affiliation': 'Colgate-Palmolive Technology Center, Piscataway, New Jersey, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Matarazzo', 'Affiliation': 'School of Dentistry, Maringa University, Maringa, Paraná, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Mairink', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Onuma', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Faveri', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.18-0501']
861,31608373,The Effect of Community-Based Nutritional Interventions on Children of Women Living With Human Immunodeficiency Virus in Rural India: A 2 × 2 Factorial Intervention Trial.,"BACKGROUND


Malnutrition is a common clinical concern among children in low-income communities affected by human immunodeficiency virus (HIV). We examined the effect of a community-based nutritional intervention on anthropometric and clinical outcomes of children of women living with HIV in rural India.
METHODS


We assigned women living with HIV and their child (oldest 3-8 years) to 1 of 4 programs: (1) community-based HIV care program, (2) program 1 + nutrition education, (3) program 1 + food supplement, and (4) all elements of programs 1-3. Study data were collected at baseline and months 6, 12, and 18. We applied mixed-effects modeling with restricted maximum likelihood estimation to examine changes in weight (all children) and CD4+ T-cell counts (children with HIV only).
RESULTS


Overall, 600 mother-child pairs were enrolled (150/group) with 100% retention at follow-up visits. Approximately 20% of children were living with HIV. Children in program 4 had higher weight gain than those in programs 1, 2, and 3 at all time points (adjusted P < .001). We found a higher increase in CD4+ T cells across all time points among participants in programs 3 and 4 compared with program 1 (adjusted P < .001). Factorial analysis suggested a synergistic effect of combining nutrition education and food supplements for weight gain but not for increase in CD4+ T cells.
CONCLUSIONS


A combination of nutrition education and food supplements provided to women living with HIV significantly increased weight and CD4+ T cells, and such interventions can be integrated into HIV-care programs in low-income settings.",2020,"Children in Program 4 had higher weight gain compared to Programs 1, 2 and 3 at all time points (adjusted p < 0.001).","['children of women living with HIV in rural India', 'women living with HIV and their child (oldest 3-8 years) to one of the four programs: 1', '600 mother-child pairs were enrolled (150 per group) with 100% retention at follow-up visits', 'women living with HIV']","['community-based nutritional interventions', 'nutrition education and food supplements', 'community-based nutritional intervention', 'community-based HIV care program']","['CD4+ T cells', 'weight and CD4+ T cells', 'weight gain']","[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",600.0,0.0719227,"Children in Program 4 had higher weight gain compared to Programs 1, 2 and 3 at all time points (adjusted p < 0.001).","[{'ForeName': 'Sanghyuk S', 'Initials': 'SS', 'LastName': 'Shin', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Veena A', 'Initials': 'VA', 'LastName': 'Satyanarayana', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Carpenter', 'Affiliation': 'Department of Epidemiology, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Yadav', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Pamujula', 'Affiliation': 'A.C. Subba Reddy Government Medical College, Nellore, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Adeline M', 'Initials': 'AM', 'LastName': 'Nyamathi', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1009']
862,31538599,Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep?,"STUDY OBJECTIVES


The safety profile of the dual orexin receptor antagonists (DORAs) are currently unknown with regard to nocturnal responsivity among people with insomnia. We compared the auditory awakening thresholds (AATs) of the DORA suvorexant (10 and 20 mg) versus placebo in 12 individuals with DSM-5 insomnia.
METHODS


The study used a double-blind, placebo-controlled, three-way crossover design. Participants were randomly assigned to a treatment sequence that included placebo, suvorexant 10 mg, and suvorexant 20 mg. At the time of maximum drug concentration, auditory tones were played during stable stage N2 sleep. Tones increased by 5-decibel (db) increments until the participant awakened. The db at awakening was recorded as the AAT and compared between conditions. The proportion of awakenings higher than 85 db was also compared between conditions. Finally, sensitivity analyses were also conducted using surrounding thresholds (80 db and 90 db).
RESULTS


The mean AAT did not differ significantly between either dose of suvorexant compared to placebo. Moreover, the proportions of individuals who remained asleep at the AAT 85 db cutoff did not differ across conditions. In addition, wake after sleep onset decreased and total sleep time increased in the suvorexant 20 mg condition compared to placebo.
CONCLUSIONS


Suvorexant (10 and 20 mg) preserved the ability to respond to nocturnal stimuli, whereas the 20-mg dose improved the sleep of people with insomnia. This suggests that DORAs such as suvorexant can effectively treat insomnia while allowing patients to awaken to nocturnal stimuli in the environment.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (Responsivity) of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs; Identifier NCT03312517; URL: https://clinicaltrials.gov/ct2/show/NCT03312517.
CITATION


Drake CL, Kalmbach DA, Cheng P, Roth T, Tran KM, Cuamatzi-Castelan A, Atkinson R, SinghM, Tonnu CV, Fellman-Couture C. Can the orexin antagonist suvorexant preserve the ability to awaken to auditory stimuli while improving sleep? J Clin Sleep Med. 2019;15(9):1285-1291.",2019,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"['people with insomnia', '12 individuals with DSM-5 insomnia', 'Non-elderly Insomniacs']","['auditory awakening thresholds (AATs) of the DORA suvorexant', 'Belsomra 10 mg and 20 mg to Placebo', 'placebo, suvorexant 10 mg, and suvorexant 20 mg', 'placebo', 'dual orexin receptor antagonists (DORAs']","['total sleep time', 'mean AAT', 'sleep of people with insomnia', 'proportion of awakenings higher', 'Ability to Awaken to Auditory Stimuli']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C3854974', 'cui_str': 'Belsomra'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3854969', 'cui_str': 'suvorexant 10 MG'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus, function (observable entity)'}]",,0.0638037,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Kieulinh Michelle', 'Initials': 'KM', 'LastName': 'Tran', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Atkinson', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Meeta', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christine V', 'Initials': 'CV', 'LastName': 'Tonnu', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7920']
863,31538602,CPAP and Health-Related Quality of Life in Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial.,"STUDY OBJECTIVES


To determine the effect of continuous positive airway pressure (CPAP) treatment on health-related quality of life (HRQoL) in adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA).
METHODS


This was a secondary outcome analysis of the RICCADSA trial, conducted in Sweden between 2005 and 2013. Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI] ≥ 15 events/h; Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires at baseline and after 12 months were included. Patients were randomized to CPAP (n = 102) or no CPAP (n = 104). The primary outcome was the between-group difference in absolute change in the SF-36 components. Within-group changes as well as variables associated with absolute change in the domains in the entire population were also tested.
RESULTS


Mean SF-36 scores were similar at baseline, ranging from 44.9 ± 9.6 to 92.2 ± 15.8 in various domains, and between-group changes from baseline were not statistically significant at 1 year. There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group. The change in Physical Component Summary (PCS) was determined by female sex (beta coefficient -0.19, 95% confidence interval [CI] -7.25 to -0.98, P = .010), baseline AHI (beta coefficient -0.19, 95% CI -0.21 to -0.03, P = .009), CPAP use (h/night) (beta coefficient -0.16, 95% CI -0.93 to -0.06, P = .028), and acute myocardial infarction at baseline (beta coefficient 0.18, 95% CI 0.59 to 5.19, P = .014). Determinants of the change in MCS from baseline were change in the ESS score (beta coefficient -0.14, 95% CI -0.87 to -0.01, P = .054) and change in the Zung Self-rated Depression Scale scores (beta coefficient -0.33, 95% CI -0.58 to -0.24, P < .001).
CONCLUSIONS


Assignment to CPAP treatment compared to no CPAP had no significant effect on HRQoL as measured by the SF-36 in adults with CAD and nonsleepy OSA. Although several components of the SF-36 scores were improved within the CPAP group, CPAP use was associated with a decrease in PCS. The improvement in MCS was determined by the improvement in daytime sleepiness and depressive mood.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT00519597.
CITATION


Wallström S, Balcan B, Thunström E, Wolf A, Peker Y. CPAP and health-related quality of life in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. J Clin Sleep Med. 2019;15(9):1311-1320.",2019,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","['Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI', 'adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial', 'Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial', 'adults with CAD and nonsleepy OSA', 'adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA']","['no CPAP', 'continuous positive airway pressure (CPAP', 'CPAP']","['CPAP and Health-Related Quality of Life', 'beta coefficient', 'MCS', 'baseline AHI (beta coefficient', 'HRQoL', 'ESS score', 'Zung Self-rated Depression Scale scores', 'Mean SF-36 scores', 'SF-36 scores', 'health-related quality of life (HRQoL', 'CPAP use (h/night) ', ' Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires', 'Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS', 'PCS', 'change in Physical Component Summary (PCS', 'Bodily pain and General health scores', 'acute myocardial infarction', 'daytime sleepiness and depressive mood', 'absolute change in the SF-36 components']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4273947', 'cui_str': 'Zung self rating depression scale score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",,0.224914,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallström', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Balcan', 'Affiliation': 'Department of Pulmonary Medicine, Marmara University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Thunström', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Peker', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7926']
864,31646953,"""Fear the Flu, Not the Flu Shot"": A Test of the Extended Parallel Process Model.","This study investigates the effects of manipulated threat and efficacy on college students' attitudes, intentions, and behavior toward receiving the influenza vaccine (flu shot). Meta-analysis results indicate that during the nearly 70-year history of fear-appeal research, as few as six studies have orthogonally manipulated threat and efficacy, randomly assigned participants to conditions, and included a behavioral dependent variable. While there may be several practical reasons for this, it is problematic theoretically. The primary goal of this study is to add to this small but important body of literature. We tested the Extended Parallel Process Model, utilizing a 2 (high threat/low threat) × 2 (high efficacy/low efficacy) between-subjects design with random assignment to conditions. Dependent variables were attitudes and intentions regarding the flu shot (measured immediately after reading the message at Time 1) and flu shot behavior (measured 30 days later at Time 2). Results indicate that participants in the high threat condition reported greater perceived severity, susceptibility, and fear than participants in the low threat condition; and that that participants in the high-efficacy condition reported greater self-efficacy and response-efficacy than individuals in the low efficacy condition. Nonetheless, the predicted threat × efficacy interaction was not observed for attitude, intention, or behavior. Instead, there was a main effect for efficacy (but not threat) on attitudes and intentions, and no effect for either efficacy or threat on behavior. The theoretical and practical implications of these findings are discussed.",2019,"Nonetheless, the predicted threat × efficacy interaction was not observed for attitude, intention, or behavior.",['college students'],['influenza vaccine (flu shot'],"['severity, susceptibility, and fear', 'self-efficacy and response-efficacy', 'attitudes and intentions regarding the flu shot', 'flu shot behavior']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0147438,"Nonetheless, the predicted threat × efficacy interaction was not observed for attitude, intention, or behavior.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Roberto', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Mongeau', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Yanqin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}, {'ForeName': 'Emi C', 'Initials': 'EC', 'LastName': 'Hashi', 'Affiliation': 'Hugh Downs School of Human Communication, Arizona State University, Tempe, Arizona, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1673520']
865,29939897,Effects of Pre-race Apneas on 400-m Freestyle Swimming Performance.,"Robertson, C, Lodin-Sundström, A, O'Hara, J, King, R, Wainwright, B, and Barlow, M. Effects of pre-race apneas on 400-m freestyle swimming performance. J Strength Cond Res 34(3): 828-837, 2020-This study aimed to establish whether a series of 3 apneas before a 400-m freestyle time-trial affected swimming performance when compared with and combined with a warm-up. Nine (6 males and 3 females) regional to national standard swimmers completed four 400-m freestyle time-trials in 4 randomized conditions: without warm-up or apneas (CON), warm-up only (WU), apneas only (AP), and warm-up and apneas (WUAP). Time-trial performance was significantly improved after WUAP (275.79 ± 12.88 seconds) compared with CON (278.66 ± 13.31 seconds, p = 0.035) and AP (278.64 ± 4.10 seconds, p = 0.015). However, there were no significant differences between the WU (276.01 ± 13.52 seconds, p > 0.05) and other interventions. Spleen volume compared with baseline was significantly reduced after the apneas by a maximum of ∼45% in the WUAP and by ∼20% in WU. This study showed that the combination of a warm-up with apneas could significantly improve 400-m freestyle swim performance compared with a control and apnea intervention. Further investigation into whether long-term apnea training can enhance this response is justified.",2020,"Time-trial performance was significantly improved after WUAP (275.79 ± 12.88 seconds) compared with CON (278.66 ± 13.31 seconds, p = 0.035) and AP (278.64 ± 4.10 seconds, p = 0.015).",['Nine (6 males and 3 females) regional to national standard swimmers completed four 400-m freestyle time-trials in 4 randomized conditions'],"['J Strength Cond Res XX(X', 'WUAP', 'Pre-race Apneas', 'without warm-up or apneas (CON), warm-up only (WU), apneas only (AP), and warm-up and apneas (WUAP']","['400-m Freestyle Swimming Performance', 'Time-trial performance', 'Spleen volume', '400-m freestyle swim performance', ""Robertson, C, Lodin-Sundström, A, O'Hara, J, King, R, Wainwright, B, and Barlow, M. Effects of pre-race apneas""]","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450068', 'cui_str': 'Swimmer (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]",9.0,0.0662951,"Time-trial performance was significantly improved after WUAP (275.79 ± 12.88 seconds) compared with CON (278.66 ± 13.31 seconds, p = 0.035) and AP (278.64 ± 4.10 seconds, p = 0.015).","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Robertson', 'Affiliation': 'School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Lodin-Sundström', 'Affiliation': 'Winter Sports Research Center, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'OʼHara', 'Affiliation': 'School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Barney', 'Initials': 'B', 'LastName': 'Wainwright', 'Affiliation': 'School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Barlow', 'Affiliation': 'School of Sport, Leeds Beckett University, Leeds, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002711']
866,29797529,Physical deconditioning is the common denominator in both obese and overweight subjects with nonalcoholic steatohepatitis.,"BACKGROUND


Obesity and decreased physical activity mirror increasing prevalence of nonalcoholic fatty liver disease (NAFLD).
AIM


We aimed to investigate associations between aerobic fitness, anthropometrics and disease parameters in patients with nonalcoholic steatohepatitis (NASH). We hypothesised that NASH subjects have lower aerobic power and capacity than untrained, sedentary, normal subjects.
METHODS


Forty subjects (60% obese, 40% overweight) with biopsy-confirmed NASH and NAFLD activity score (NAS) ≥4 were enrolled in a clinical trial where anthropometrics, laboratories, liver fat content by MRI, activity, and aerobic fitness by cycle ergometry data were obtained.
RESULTS


NASH subjects were significantly deconditioned compared to 148 untrained, sedentary, healthy subjects from our laboratory in aerobic power (VO2peak) (NASH 16.8 ± 6.6 vs control 28.4 ± 10.6 mL/kg/min, P < 0.0001) and capacity (VO2 at lactate threshold [LT]) (NASH 8.3 ± 2.5 vs control 14.1 ± 5.9 mL/kg/min, P < 0.0001). NASH subjects' fitness was comparable to the ""least fit"" tertile of controls: VO2peak [NASH 16.8 ± 6.6 vs ""least fit"" 17.3 ± 3.3, P = 0.64]) and VO2 at LT (NASH 8.3 ± 2.5 vs ""least fit"" 9.3 ± 2.1, P = 0.31). Fitness was similar in obese compared to overweight subjects (adjusted for gender) and was not correlated with visceral adiposity or NAS. Engaging in dedicated cardiovascular activity correlated with higher VO2peak and VO2peak at LT.
CONCLUSIONS


Aerobic deconditioning was universally present in NASH subjects. NASH subjects' fitness was similar to our laboratory's ""least fit"" untrained, sedentary control subjects. Further research investigating NASH patients' ability to improve low baseline aerobic fitness is warranted.",2018,< 0.0001) and capacity (VO2 at lactate threshold [LT]),"['148 untrained, sedentary, healthy subjects from our laboratory in aerobic power (VO2peak) (NASH 16.8\xa0±\xa06.6 vs control 28.4\xa0±', 'Forty subjects (60% obese, 40% overweight) with biopsy-confirmed NASH and NAFLD activity score (NAS) ≥4', 'obese and overweight subjects with nonalcoholic steatohepatitis', 'patients with nonalcoholic steatohepatitis (NASH']",['NASH'],"['capacity (VO2 at lactate threshold [LT', 'visceral adiposity or NAS']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]",40.0,0.028039,< 0.0001) and capacity (VO2 at lactate threshold [LT]),"[{'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Argo', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Stine', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA.'}, {'ForeName': 'Z H', 'Initials': 'ZH', 'LastName': 'Henry', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lackner', 'Affiliation': 'Institute of Pathology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Patrie', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Caldwell', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.14803']
867,31899473,"Effects of clopidogrel vs. prasugrel vs. ticagrelor on endothelial function, inflammatory parameters, and platelet function in patients with acute coronary syndrome undergoing coronary artery stenting: a randomized, blinded, parallel study.","AIMS


In a randomized, parallel, blinded study, we investigate the impact of clopidogrel, prasugrel, or ticagrelor on peripheral endothelial function in patients undergoing stenting for an acute coronary syndrome.
METHODS AND RESULTS


The primary endpoint of the study was the change in endothelium-dependent flow-mediated dilation (FMD) following stenting. A total of 90 patients (age 62 ± 9 years, 81 males, 22 diabetics, 49 non-ST elevation myocardial infarctions) were enrolled. There were no significant differences among groups in any clinical parameter. Acutely before stenting, all three drugs improved FMD without differences between groups (P = 0.73). Stenting blunted FMD in the clopidogrel and ticagrelor group (both P < 0.01), but not in the prasugrel group. During follow-up, prasugrel was superior to clopidogrel [mean difference 2.13, 95% confidence interval (CI) 0.68-3.58; P = 0.0047] and ticagrelor (mean difference 1.57, 95% CI 0.31-2.83; P = 0.0155), but this difference was limited to patients who received the study therapy 2 h before stenting. Ticagrelor was not significantly superior to clopidogrel (mean difference 0.55, 95% CI -0.73 to 1.82; P = 0.39). No significant differences were seen among groups for low-flow-mediated dilation. Plasma interleukin (IL)-6 (P = 0.02 and P = 0.01, respectively) and platelet aggregation reactivity in response to adenosine diphosphate (P = 0.002 and P = 0.035) were lower in the prasugrel compared to clopidogrel and ticagrelor group.
CONCLUSION


As compared to ticagrelor and clopidogrel, therapy with prasugrel in patients undergoing stenting for an acute coronary syndrome is associated with improved endothelial function, stronger platelet inhibition, and reduced IL-6 levels, all of which may have prognostic implications. This effect was lost in patients who received the study medication immediately after stenting.
EUDRACT-NO


2011-005305-73.",2020,"During follow-up, prasugrel was superior to clopidogrel [mean difference 2.13, 95% confidence interval (CI) 0.68-3.58; P = 0.0047] and ticagrelor (mean difference 1.57, 95% CI 0.31-2.83; P = 0.0155), but this difference was limited to patients who received the study therapy 2 h before stenting.","['patients who received the study medication immediately after stenting', '90 patients (age 62\u2009±\u20099\u2009years, 81 males, 22 diabetics, 49 non-ST elevation myocardial infarctions) were enrolled', 'patients with acute coronary syndrome undergoing coronary artery stenting', 'patients undergoing stenting for an acute coronary syndrome']","['clopidogrel, prasugrel, or ticagrelor', 'ticagrelor and clopidogrel', 'Ticagrelor', 'prasugrel', 'ticagrelor', 'clopidogrel vs. prasugrel vs. ticagrelor']","['change in endothelium-dependent flow-mediated dilation (FMD', 'Plasma interleukin (IL)-6', 'endothelial function, inflammatory parameters, and platelet function', 'low-flow-mediated dilation', 'Stenting blunted FMD', 'FMD', 'peripheral endothelial function', 'platelet aggregation reactivity', 'endothelial function, stronger platelet inhibition, and reduced IL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",90.0,0.273975,"During follow-up, prasugrel was superior to clopidogrel [mean difference 2.13, 95% confidence interval (CI) 0.68-3.58; P = 0.0047] and ticagrelor (mean difference 1.57, 95% CI 0.31-2.83; P = 0.0155), but this difference was limited to patients who received the study therapy 2 h before stenting.","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schnorbus', 'Affiliation': 'Zentrum für Kardiologie, Kardiologie I, Universitätsmedizin Mainz, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Daiber', 'Affiliation': 'Zentrum für Kardiologie, Kardiologie I, Universitätsmedizin Mainz, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Jurk', 'Affiliation': 'Center for Thrombosis and Hemostasis, Universitätsmedizin Mainz, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Warnke', 'Affiliation': 'Interdisciplinary Center for Clinical Trials (IZKS), Universitätsmedizin Mainz, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'Koenig', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}, {'ForeName': 'Karl J', 'Initials': 'KJ', 'LastName': 'Lackner', 'Affiliation': 'Institute of Clinical Chemistry and Laboratory Medicine, Universitätsmedizin Mainz, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'Zentrum für Kardiologie, Kardiologie I, Universitätsmedizin Mainz, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Zentrum für Kardiologie, Kardiologie I, Universitätsmedizin Mainz, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz917']
868,31642526,Randomized controlled trial of an applied behavior analytic intervention for food selectivity in children with autism spectrum disorder.,"Food selectivity is a common problem for children with autism spectrum disorder (ASD; Schreck, Williams, & Smith, 2004). Behavior-analytic interventions have the most empirical support for feeding disorders (Sharp, Jaquess, Morton, & Miles, 2011). However, there are no randomized controlled trials that have evaluated its effects with a well-defined cohort of children with ASD. In the current investigation, we randomly assigned 6 young children with ASD and food selectivity to either an applied behavior analytic intervention or a wait-list control. We used a crossover randomized controlled trial to evaluate the effects of a multicomponent applied behavior analytic intervention on independent acceptance and mouth clean of 16 novel foods. We subsequently exposed the wait-list control group to the intervention. We also evaluated the effects of the intervention on individual participants with single-case designs. The percentage of independent acceptance and mouth clean increased for the applied behavior analytic intervention group, but not for the wait-list control group until we implemented the intervention.",2019,"The percentage of independent acceptance and mouth clean increased for the applied behavior analytic intervention group, but not for the wait-list control group until we implemented the intervention.","['children with ASD', 'children with autism spectrum disorder', '16 novel foods', '6 young children with ASD and', 'individual participants with single-case designs', 'children with autism spectrum disorder (ASD']","['applied behavior analytic intervention', 'food selectivity to either an applied behavior analytic intervention or a wait-list control', 'multicomponent applied behavior analytic intervention']",['percentage of independent acceptance and mouth clean'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",,0.0781908,"The percentage of independent acceptance and mouth clean increased for the applied behavior analytic intervention group, but not for the wait-list control group until we implemented the intervention.","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Peterson', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}, {'ForeName': 'Cathleen C', 'Initials': 'CC', 'LastName': 'Piazza', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Ibañez', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Fisher', 'Affiliation': ""University of Nebraska Medical Center's Munroe-Meyer Institute.""}]",Journal of applied behavior analysis,['10.1002/jaba.650']
869,31005596,"Desmetramadol Has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials.","Desmetramadol is an investigational analgesic consisting of (+) and (-) enantiomers of the tramadol metabolite O-desmethyltramadol (M1). Tramadol is racemic and exerts analgesia by monoaminergic effects of (-)-tramadol and (-)-M1, and by the opioid (+)-M1. Tramadol labeling indicates cytochrome P450 (CYP) isozyme 2D6 ultrarapid metabolizer can produce dangerous (+)-M1 levels, and CYP2D6 poor metabolizers insufficient (+)-M1 for analgesia. We hypothesized that desmetramadol could provide the safety and analgesia of tramadol without its metabolic liabilities. We conducted consecutive double-blind, randomized, placebo-controlled, 3 segment cross-over trials A and B to investigate the steady-state pharmacokinetics and analgesia of 20 mg desmetramadol and 50 mg tramadol in 103 healthy participants without (n = 43) and with (n = 60) cotreatment with the CYP inhibitor paroxetine. In the absence of CYP inhibition (trial A), 20 mg desmetramadol and 50 mg tramadol dosed every 6 hours gave equivalent steady-state (+)-M1, similar adverse events, and analgesia significantly greater than placebo, but equal to each other. In trial B, CYP inhibition significantly depressed tramadol steady-state (+)-M1, reduced its adverse events, and led to insignificant analgesia comparable with placebo. In contrast, CYP inhibition in trial B had no deleterious effect on desmetramadol (+)-M1 or (-)-M1, which gave significant analgesia as in trial A and superior to tramadol (P = .003). Desmetramadol has the safety and efficacy of tramadol without its metabolic liabilities. CLINICALTRIALS.GOV REGISTRATIONS: NCT02205554, NCT03312777 PERSPECTIVE: To our knowledge, this is the first study of desmetramadol in humans and the first to show it provides the same safety and analgesia as tramadol, but without tramadol's metabolic liabilities and related drug-drug interactions. Desmetramadol could potentially offer expanded safety and usefulness to clinicians seeking an alternative to schedule II opioids.",2019,"In trial B, CYP inhibition significantly depressed tramadol steady-state (+)-M1, reduced its adverse events, and led to insignificant analgesia comparable with placebo.",['103 healthy participants without (n\u202f=\u202f43) and with (n\u202f=\u202f60) cotreatment with the'],"['Desmetramadol', 'tramadol', 'placebo', 'desmetramadol and 50 mg tramadol', 'CYP inhibitor paroxetine', 'Tramadol', 'Placebo', 'tramadol metabolite O-desmethyltramadol (M1']","['tramadol steady-state (+)-M1', 'desmetramadol (+)-M1 or (-)-M1']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0215051', 'cui_str': 'tramadol M1 metabolite'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",103.0,0.114123,"In trial B, CYP inhibition significantly depressed tramadol steady-state (+)-M1, reduced its adverse events, and led to insignificant analgesia comparable with placebo.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Zebala', 'Affiliation': 'Syntrix Pharmaceuticals, Auburn, Washington. Electronic address: jzebala@syntrixbio.com.'}, {'ForeName': 'Shawn L', 'Initials': 'SL', 'LastName': 'Searle', 'Affiliation': 'PRA Health Sciences, Salt Lake City, Utah.'}, {'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, Utah.'}, {'ForeName': 'Matt S', 'Initials': 'MS', 'LastName': 'Johnson', 'Affiliation': 'DF/Net Research, Seattle, Washington.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Schuler', 'Affiliation': 'Syntrix Pharmaceuticals, Auburn, Washington.'}, {'ForeName': 'Dean Y', 'Initials': 'DY', 'LastName': 'Maeda', 'Affiliation': 'Syntrix Pharmaceuticals, Auburn, Washington.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Kahn', 'Affiliation': 'Syntrix Pharmaceuticals, Auburn, Washington.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.04.005']
870,29719302,A Randomized Phase II Open-Label Multi-Institution Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma.,"OBJECTIVES


To investigate the clinical efficacy and tolerability of the combination of bevacizumab (B) and erlotinib (E) compared to sorafenib (S) as first-line treatment for patients with advanced hepatocellular carcinoma (HCC).
METHODS


A total of 90 patients with advanced HCC, Child-Pugh class A-B7 cirrhosis, and no prior systemic therapy were randomly assigned (1: 1) to receive either 10 mg/kg B intravenously every 14 days and 150 mg E orally daily (n = 47) (B+E) or 400 mg S orally twice daily (n = 43). The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), time to progression, and safety and tolerability.
RESULTS


The median OS was 8.55 months (95% CI: 7.00-13.9) for patients treated with B+E and 8.55 months (95% CI: 5.69-12.2) for patients receiving S. The hazard ratio (HR) for OS was 0.92 (95% CI: 0.57-1.47). The median EFS was 4.37 months (95% CI: 2.99-7.36) for patients receiving B+E and 2.76 months (95% CI: 1.84-4.80) for patients receiving S. The HR for EFS was 0.67 (95% CI: 0.42-1.07; p = 0.09), favoring B+E over S. When OS was assessed among patients who were Child-Pugh class A, the median OS was 11.4 months (95% CI: 7.5-15.7) for patients treated with B+E (n = 39) and 10.26 months (95% CI: 5.9-13.0) for patients treated with S (n = 38) (HR = 0.88; 95% CI: 0.53-1.46).
CONCLUSIONS


There was no difference in efficacy between the B+E and S arms, although the safety and tolerability profile tended to favor B+E over S based on competing risk analysis.",2018,The hazard ratio (HR) for OS was 0.92,"['patients who were Child', 'Patients with Advanced Hepatocellular Carcinoma', '90 patients with advanced HCC, Child', 'patients with advanced hepatocellular carcinoma (HCC', 'Pugh class A-B7 cirrhosis, and no prior systemic therapy']","['Sorafenib', 'Bevacizumab and Erlotinib', 'bevacizumab (B) and erlotinib (E', 'sorafenib (S', 'B+E']","['median EFS', 'safety and tolerability profile', 'event-free survival (EFS), objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), time to progression, and safety and tolerability', 'median OS', 'overall survival (OS', 'efficacy', 'clinical efficacy and tolerability', 'hazard ratio (HR) for OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",90.0,0.0953679,The hazard ratio (HR) for OS was 0.92,"[{'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'Thomas', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Garrett-Mayer', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Munazza', 'Initials': 'M', 'LastName': 'Anis', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Anderton', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Bentz', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Andie', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brisendine', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Weiss', 'Affiliation': 'Department of Oncology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Abby B', 'Initials': 'AB', 'LastName': 'Siegel', 'Affiliation': 'New York-Presbyterian Hospital, Columbia University, New York, New York, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'GI Oncology Research, Sarah Canon Research Institute, Nashville, Tennessee, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Baron', 'Affiliation': 'California Pacific Medical Center, San Francisco, California, USA.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Duddalwar', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'El-Khoueiry', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA.'}]",Oncology,['10.1159/000485384']
871,28482106,Social Participation Modifies the Effect of a Structured Physical Activity Program on Major Mobility Disability Among Older Adults: Results From the LIFE Study.,"Objectives


To investigate whether baseline social participation modifies the effect of a long-term structured physical activity (PA) program on major mobility disability (MMD).
Methods


1,635 sedentary adults (70-89 years) with physical limitations were randomized to either a structured PA or health education (HE) intervention. Social participation was defined categorically at baseline. High social participation was defined as attending organized group functions at least once per week and visiting with noncohabitating friends and family ≥7 hr per week. Anything less was considered limited social participation. Participants performed a standardized walking test at baseline and every 6 months for up to 42 months. MMD was defined as the loss in the ability to walk 400 m.
Results


There was a significant intervention by social participation interaction (p = .003). Among individuals with high levels of social participation, those randomized to PA had significantly lower incidence of MMD (hazard ratio [HR], 0.43 [95% confidence interval (CI), 0.27-0.68]; p < .01) than those randomized to HE. Individuals with limited social participation showed no mobility benefit of the PA intervention when compared with their HE counterparts (HR, 0.92 [95% CI, 0.77-1.11]; p = .40).
Discussion


Our findings suggest that baseline social participation is an important factor for the success of a PA intervention aimed at delaying mobility disability.",2018,"Individuals with limited social participation showed no mobility benefit of the PA intervention when compared with their HE counterparts (HR, 0.92","['1,635 sedentary adults (70-89 years) with physical limitations', 'individuals with high levels of social participation', 'Older Adults']","['Structured Physical Activity Program', 'long-term structured physical activity (PA) program', 'structured PA or health education (HE) intervention']","['Social participation', 'major mobility disability (MMD', 'MMD', 'social participation interaction', 'mobility benefit', 'Major Mobility Disability']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",1635.0,0.0233333,"Individuals with limited social participation showed no mobility benefit of the PA intervention when compared with their HE counterparts (HR, 0.92","[{'ForeName': 'Duane B', 'Initials': 'DB', 'LastName': 'Corbett', 'Affiliation': 'Department of Aging and Geriatric Research, College of Medicine, University of Florida, Gainesville.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': 'Department of Kinesiology, University of Massachusetts, Amherst.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'McDermott', 'Affiliation': 'Department of Medicine and Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Laboratory, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Health Research & Policy and Medicine, School of Medicine, Stanford University, California.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, College of Medicine, University of Florida, Gainesville.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, College of Medicine, University of Florida, Gainesville.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbx051']
872,31476413,Loneliness in healthy young adults predicts inflammatory responsiveness to a mild immune challenge in vivo.,"The established link between loneliness and poor health outcomes may stem from aberrant inflammatory regulation. The present study tested whether loneliness predicted the inflammatory response to a standardised in vivo immune challenge. Using a within-subjects double blind placebo-controlled design, 40 healthy men (mean age = 25, SD = 5) received a Salmonella Typhi vaccination (0.025 mg; Typhim Vi, Sanofi Pasteur, UK) and placebo (saline) on two separate occasions. Loneliness was assessed using the R-UCLA loneliness scale. Regression analyses showed that those that reported feeling more lonely exhibited an elevated interleukin-6 response (β = 0.564, 95% confidence interval [0.003, 0.042], p < .05). This association withstood adjustment for potentially confounding variables, including age, sleep quality, socio-emotional factors, and health factors. The present findings are in line with evidence that loneliness may shift immune system responsivity, suggesting a potential biobehavioural pathway linking loneliness to impaired health.",2019,"Regression analyses showed that those that reported feeling more lonely exhibited an elevated interleukin-6 response (β = .564, 95% confidence interval [.003, .042], p < .05).","['Healthy Young Adults', '40 healthy men (mean age = 25, SD = 5']","['placebo', 'Salmonella Typhi vaccination (0.025 mg; Typhim Vi, Sanofi Pasteur, UK) and placebo (saline']","['Loneliness', 'age, sleep quality, socio-emotional factors, and health factors', 'elevated interleukin-6 response', 'R-UCLA loneliness scale']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036125', 'cui_str': 'Salmonella typhosa'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4517400', 'cui_str': 'Zero point zero two five'}, {'cui': 'C0378248', 'cui_str': 'Typhim VI'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0222045'}]",40.0,0.393274,"Regression analyses showed that those that reported feeling more lonely exhibited an elevated interleukin-6 response (β = .564, 95% confidence interval [.003, .042], p < .05).","[{'ForeName': 'Leonie J T', 'Initials': 'LJT', 'LastName': 'Balter', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham B15 2TT, UK; Psychology Department, Clinical Psychology, University of Amsterdam, Amsterdam 1018 WT, the Netherlands. Electronic address: L.J.T.balter@uva.nl.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Raymond', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Aldred', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Institute of Immunity and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Jet J C S', 'Initials': 'JJCS', 'LastName': 'Veldhuijzen van Zanten', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Higgs', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Jos A', 'Initials': 'JA', 'LastName': 'Bosch', 'Affiliation': 'Psychology Department, Clinical Psychology, University of Amsterdam, Amsterdam 1018 WT, the Netherlands.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.08.196']
873,31638594,The Effect of an App for Day-to-Day Postoperative Care Education on Patients With Total Knee Replacement: Randomized Controlled Trial.,"BACKGROUND


Patients who undergo primary Total Knee Replacement surgery (TKR) are often discharged within 1-3 days after surgery. With this relatively short length of hospital stay, a patient's self-management is a crucial factor in optimizing the outcome of their treatment. In the case of TKR, self-management primarily involves adequate pain management, followed by physiotherapy exercises and daily self-care activities. Patients are educated on all these topics by hospital staff upon discharge from the hospital but often struggle to comprehend this information due to its quantity, complexity, and the passive mode of communication used to convey it.
OBJECTIVE


This study primarily aims to determine whether actively educating TKR patients with timely, day-to-day postoperative care information through an app could lead to a decrease in their level of pain compared to those who only receive standard information about their recovery through the app. In addition, physical functioning, quality of life, ability to perform physiotherapy exercises and daily self-care activities, satisfaction with information, perceived involvement by the hospital, and health care consumption were also assessed.
METHODS


A multicenter randomized controlled trial was performed in five Dutch hospitals. In total, 213 patients who had undergone elective, primary, unilateral TKR participated. All patients had access to an app for their smartphone and tablet to guide them after discharge. The intervention group could unlock day-to-day information by entering a personal code. The control group only received weekly, basic information. Primary (level of pain) and secondary outcomes (physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption) were measured using self-reported online questionnaires. All outcomes were measured weekly in the four weeks after discharge, except for physical functioning and quality of life, which were measured at baseline and at four weeks after discharge. Data was analyzed using Student t tests, chi-square tests, and linear mixed models for repeated measures.
RESULTS


In total, 114 patients were enrolled in the intervention group (IG) and 99 in the control group (CG). Four weeks after discharge, patients in the IG performed significantly better than patients in the CG on all dimensions of pain: pain at rest (mean 3.45 vs mean 4.59; P=.001), pain during activity (mean 3.99 vs mean 5.08; P<.001) and pain at night (mean 4.18 vs mean 5.21; P=.003). Additionally, significant differences were demonstrated in favor of the intervention group for all secondary outcomes.
CONCLUSIONS


In the four weeks following TKR, the active and day-to-day education of patients via the app significantly decreased their level of pain and improved their physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption compared to standard patient education. Given the rising number of TKR patients and the increased emphasis on self-management, we suggest using an app with timely postoperative care education as a standard part of care.
TRIAL REGISTRATION


Netherlands Trial Register NTR7182; https://www.trialregister.nl/trial/6992.",2019,"Four weeks after discharge, patients in the IG performed significantly better than patients in the CG on all dimensions of pain:","['114 patients were enrolled in the intervention group (IG) and 99 in the control group (CG', '213 patients who had undergone elective, primary, unilateral TKR participated', 'five Dutch hospitals', 'Patients who undergo primary Total Knee Replacement surgery (TKR', 'Patients With Total Knee Replacement']","['App for Day-to-Day Postoperative Care Education', 'CG']","['pain at rest', 'physical functioning, quality of life, ability to perform physiotherapy exercises and daily self-care activities, satisfaction with information, perceived involvement by the hospital, and health care consumption', 'pain at night', 'pain', 'Primary (level of pain) and secondary outcomes (physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption', 'level of pain and improved their physical functioning, quality of life, ability to perform physiotherapy exercises and activities of daily self-care, satisfaction with information, perceived involvement by the hospital, and health care consumption', 'physical functioning and quality of life', 'pain during activity']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",213.0,0.109026,"Four weeks after discharge, patients in the IG performed significantly better than patients in the CG on all dimensions of pain:","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Timmers', 'Affiliation': 'Interactive Studios, Rosmalen, Netherlands.'}, {'ForeName': 'Loes', 'Initials': 'L', 'LastName': 'Janssen', 'Affiliation': 'Máxima MC, Veldhoven, Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'van der Weegen', 'Affiliation': 'Sint Anna Hospital, Geldrop, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Das', 'Affiliation': 'Sint Anna Hospital, Geldrop, Netherlands.'}, {'ForeName': 'Willem-Jan', 'Initials': 'WJ', 'LastName': 'Marijnissen', 'Affiliation': 'Albert Schweitzer Hospital, Dordrecht, Netherlands.'}, {'ForeName': 'Gerjon', 'Initials': 'G', 'LastName': 'Hannink', 'Affiliation': 'Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Babette C', 'Initials': 'BC', 'LastName': 'van der Zwaard', 'Affiliation': ""Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Plat', 'Affiliation': ""Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Thomassen', 'Affiliation': ""Haaglanden Medical Center, 's-Gravenhage, Netherlands.""}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'Swen', 'Affiliation': ""Haaglanden Medical Center, 's-Gravenhage, Netherlands.""}, {'ForeName': 'Rudolf B', 'Initials': 'RB', 'LastName': 'Kool', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, Nijmegen, Netherlands.'}, {'ForeName': 'Frederik Okke', 'Initials': 'FO', 'LastName': 'Lambers Heerspink', 'Affiliation': 'VieCuri Medical Centre, Venlo, Netherlands.'}]",JMIR mHealth and uHealth,['10.2196/15323']
874,31636243,Effects of adding dexmedetomidine to local infiltration of bupivacaine on postoperative pain in pediatric herniorrhaphy: a randomized clinical trial.,"BACKGROUND


Postoperative pain is a major problem, especially in children, as their tolerance level is lower and several drugs are contraindicated in childhood. This study aimed to compare the effect of dexmedetomidine added to local infiltration of bupivacaine for postoperative pain relief in children undergoing inguinal herniorrhaphy.
METHODS


This double-blind, randomized clinical trial included 60 children aged 6-72 months undergoing unilateral herniorrhaphy at selected hospitals in Shiraz, Iran, randomly allocated into two groups, 30 in each group. One group received 1 µg/kg dexmedetomidine plus local infiltration of 0.2 ml/kg bupivacaine 0.5% at the incision site before surgery (BD), and the other group received bupivacaine and normal saline (BO). Analgesic requirements, emergence time, and nausea/vomiting, postoperative pain and sedation scores were assessed for 4 h after the operation. Heart rate (HR), systolic blood pressure (SBP), and oxygen saturation (SaO2) were recorded at baseline, and at 10 and 20 min after injection.
RESULTS


Eighty percent were boy in each group; mean age was 22.75 ± 18.63 months. SaO2 and SBP were not different between the groups, while HR was significantly lower in the BD group at 10 and 20 min after injection (P <0.05). BD group had a lower pain score at 1 and 2 h after the operation, a higher sedation score at the first three time intervals, and longer emergence time than BO group (all P <0.001). BD group had a lower pain score at 1 and 2 h after the operation (P < 0.001, P < 0.047 respectively).
CONCLUSIONS


Addition of dexmedetomidine to local infiltration of bupivacaine in children undergoing herniorrhaphy significantly reduced postoperative pain and increased sedation.",2020,"There was no difference between the groups regarding SaO2 and SBP, while HR was significantly lower in BD group after 10 and 20 minutes (P<0.05).","['children undergoing inguinal herniorrhaphy', '60 patients were recruited in the study, 30 in each group', '24 patients (80%) were boys and 6 (20%) were girls', 'children undergoing', '60 children aged 6-72 months undergoing unilateral herniorrhaphy at selected hospitals, Shiraz, Iran', 'Pediatric Herniorrhaphy']","['herniorrhaphy', 'dexmedetomidine', 'Dexmedetomidine', 'bupivacaine and normal saline (BO', 'dexmedetomidine plus local infiltration of 0.2 mL/kg bupivacaine', 'bupivacaine', 'Bupivacaine']","['postoperative pain', 'pain score', 'Heart rate (HR), systolic blood pressure (SBP), and arterial oxygen saturation (SaO2', 'Postoperative pain and sedation score', 'Analgesic requirements, emergence time, and nausea/vomiting', 'Postoperative Pain', 'Sedation score', 'emergence time', 'SaO2 and SBP, while HR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",60.0,0.299113,"There was no difference between the groups regarding SaO2 and SBP, while HR was significantly lower in BD group after 10 and 20 minutes (P<0.05).","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Azemati', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Pourali', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Aghazadeh', 'Affiliation': 'Department of Anesthesiology and Intensive Care Unit, Medical College, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Korean journal of anesthesiology,['10.4097/kja.19111']
875,29575043,Preventing family transmission of anxiety: Feasibility RCT of a brief intervention for parents.,"OBJECTIVES


Children of anxious parents are at high risk of anxiety disorders themselves. The evidence suggests that this is due to environmental rather than genetic factors. However, we currently do little to reduce this risk of transmission. There is evidence that supporting parenting in those with mental health difficulties can ameliorate this risk. Therefore, the objective of this study was to test the feasibility of a new one-session, group-based, preventive parenting intervention for parents with anxiety disorders.
DESIGN


Feasibility Randomized Controlled Trial.
METHODS


A total of 100 parents with anxiety disorders, recruited from adult mental health services in England (and child aged 3-9 years), were randomized to receive the new intervention (a 1-day, group workshop), or to treatment as usual. Children's anxiety disorder and anxiety symptoms were assessed to 12 months by outcome assessors who were blind to group allocation. Exploratory analyses were conducted on an intention to treat basis, as far as possible.
RESULTS


A total of 51 participants were randomized to the intervention condition and 49 to the control condition (82% and 80% followed to 12 months, respectively). The attendance rate was 59%, and the intervention was highly acceptable to parents who received it. The RCT was feasible, and 12-month follow-up attrition rates were low. Children whose parents were in the control condition were 16.5% more likely to have an anxiety disorder at follow-up than those in the intervention group. No adverse events were reported.
CONCLUSIONS


An inexpensive, light-touch, psycho-educational intervention may be useful in breaking the intergenerational cycle of transmission of anxiety disorders. A substantive trial is warranted.
PRACTITIONER POINTS


Anxiety disorders run in families, but we currently do little to help anxious parents to raise confident children. A brief group workshop was highly acceptable to such parents and was very inexpensive to run. Children of parents who took part in the brief intervention were 16.5% less likely to have an anxiety disorder, 1 year later, than children whose parents were in the control group. This was a feasibility study, and while it showed that both the intervention and the research were feasible, the study needs replicating with a much larger sample. Many parents faced barriers to attending the workshop, and future efforts should focus on widening accessibility. We were unable to obtain sufficient self-report data from children, so the outcomes are based on parent report only.",2018,"Children of parents who took part in the brief intervention were 16.5% less likely to have an anxiety disorder, 1 year later, than children whose parents were in the control group.","['parents', 'parents with anxiety disorders', 'Children of anxious parents', 'A total of 51 participants', '100 parents with anxiety disorders, recruited from adult mental health services in England (and child aged 3-9\xa0years']","['preventive parenting intervention', 'new intervention', 'inexpensive, light-touch, psycho-educational intervention']","[""Children's anxiety disorder and anxiety symptoms"", 'anxiety disorder', 'adverse events', 'attendance rate']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0423553', 'cui_str': 'Light touch, function (observable entity)'}]","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",100.0,0.051371,"Children of parents who took part in the brief intervention were 16.5% less likely to have an anxiety disorder, 1 year later, than children whose parents were in the control group.","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Cartwright-Hatton', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Ewing', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Dash', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hughes', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Thompson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Cassie M', 'Initials': 'CM', 'LastName': 'Hazell', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Andy P', 'Initials': 'AP', 'LastName': 'Field', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Startup', 'Affiliation': 'Research and Development, Sussex Education Centre, Mill View Hospital, Hove, UK.'}]",The British journal of clinical psychology,['10.1111/bjc.12177']
876,31860383,Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population.,"HPV remains the most common sexually transmitted disease worldwide, despite improvements in awareness, screening, prophylactic vaccination uptake, and surgical treatment. VGX-3100 is an immunotherapy that uses electroporation to introduce DNA encoding for modified HPV-16 and HPV-18, E6-and E7 proteins into myocytes to stimulate an effector T cell response. We now report immunogenicity and safety of VGX-3100 for a refrigeration-stable formulation, which improves patient-care setting usability. This multi-arm, double-blinded, randomized trial enrolled 235 healthy men and women to receive either a refrigerated (RF) or frozen formulation (FF) of VGX-3100. Three doses were administered intramuscularly with electroporation at 0, 4, and 12 weeks. Non-inferiority of RF to FF was assessed by comparing the proportion of subjects who achieved a ≥2-fold increase from baseline to Week 14 in Spot Forming Units/10 6  PMBCs using an interferon-γ enzyme-linked immunospot assay. There were no related SAEs. Injection site reactions were the most common adverse event (54%, RF; 66%, FF) the majority of which resolved within a few minutes following administration. The primary endpoint was met with 89.9% of RF recipients and 97.2% of FF recipients reaching a ≥2-fold rise in SFU/10 6  PBMC, 2 weeks following the last dose; RF was statistically non-inferior to FF ( p  = .022). A systemic, immunologic approach has the potential to fill a critical gap in the ability to treat men and women with high grade HPV diseases. These safety and immunogenicity data are supportive of the continued development of a refrigerated formulation of VGX-3100.",2020,"Injection site reactions were the most common adverse event (54%, RF; 66%, FF) the majority of which resolved within a few minutes following administration.","['235 healthy men and women to receive either a', 'men and women with high grade HPV diseases', 'healthy young adult population']","['VGX-3100 formulations', 'VGX-3100', 'refrigerated (RF) or frozen formulation (FF) of VGX-3100']","['Safety and immunogenicity', 'inferiority of RF to FF']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2703096', 'cui_str': 'VGX-3100'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",235.0,0.191103,"Injection site reactions were the most common adverse event (54%, RF; 66%, FF) the majority of which resolved within a few minutes following administration.","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Hollenberg', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Krieger', 'Affiliation': 'Miami Research Associates , Miami, FL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Samuels', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Kraynyak', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Sylvester', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morrow', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dallas', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Prakash K', 'Initials': 'PK', 'LastName': 'Bhuyan', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1695459']
877,31501226,"Heart Rate Variability and Cardiac Autonomic Dysfunction: Prevalence, Risk Factors, and Relationship to Arterial Stiffness in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.","OBJECTIVE


To determine whether prior type 2 diabetes (T2D) treatment or glycemic control over time are independently associated with heart rate variability (HRV) and whether the presence of cardiac autonomic dysfunction is associated with arterial stiffness in young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
RESEARCH DESIGN AND METHODS


Heartbeats over 10 min were measured to derive the normal R-Rs (NN intervals). Outcomes included the standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF). Autonomic dysfunction was defined as ≥3 of 5 abnormal HRV indices compared with obese controls from a separate study.
RESULTS


A total of 397 TODAY participants were evaluated 7 years after randomization. TODAY participants had reduced HRV (SDNN 58.1 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD 53.2 ± 36.7 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001). Cardiac autonomic dysfunction was present in 8% of TODAY participants, and these participants had greater pulse wave velocity compared with those without dysfunction ( P  = 0.0001). HRV did not differ by randomized treatment, but higher hemoglobin A1c (HbA 1c ) over time was independently associated with lower SDNN and RMSSD and higher LF:HF ratio after adjustment for age, race-ethnicity, sex, and BMI.
CONCLUSIONS


Young adults with youth-onset T2D show evidence of cardiac autonomic dysfunction with both parasympathetic and sympathetic impairments that are associated with higher HbA 1c .",2019,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"['A total of 397 TODAY participants were evaluated 7 years after randomization', 'Young adults with youth-onset T2D', 'young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study']","['LF', 'prior type 2 diabetes (T2D) treatment or glycemic control']","['HF ratio', 'Autonomic dysfunction', 'heart rate variability (HRV', 'parasympathetic loss', 'HRV', 'standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF', 'Heart Rate Variability and Cardiac Autonomic Dysfunction', 'Cardiac autonomic dysfunction', 'hemoglobin A1c (HbA 1c ) over time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",397.0,0.0563142,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD elghorml@bsc.gwu.edu.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Vajravelu', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Farrell', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, CA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}]",Diabetes care,['10.2337/dc19-0993']
878,31578132,Effects of caffeine on inspiratory muscle function.,"Research suggests that caffeine can enhance measures of muscular strength in the upper and lower extremities, although the literature is somewhat equivocal. Little is known on whether or not caffeine will improve maximal inspiratory pressure (MIP), a surrogate measure of inspiratory muscle strength. The purpose of the study was to determine the effects of a moderate dose of caffeine on inspiratory muscle function. Fifteen (8 male, 7 female) healthy adults (mean ± SD: age = 24.3 ± 6.4 years; height = 1.75 ± 0.11 m; body mass = 78.8 ± 16.5 kg) volunteered to participate in the study which used a double-blind, placebo-controlled, cross-over design. During the initial visit, baseline data was collected and participants were familiarized with inspiratory muscle measurements. For the second and third visits, participants ingested either a 5 mg kg -1  dose of caffeine (CAF) or placebo capsule (PL). After one hour, they completed at least 12 maximal inspiratory manoeuvres with 1 min rest between each attempt. MIP, maximal inspiratory peak pressure (PP), and maximal rate of pressure development (MRPD) were recorded. The CAF trial resulted in significantly higher MIP (154.7 ± 35.8 vs. 146.6 ± 37.6 cmH 2 O;  p  = 0.02) and PP (165.8 ± 36.8 vs. 158.3 cmH 2 O;  p  = 0.01) compared to the PL condition. No significant difference was observed in MRPD ( p  = 0.18). MIP and PP improved after ingestion of caffeine compared to the placebo condition. The findings from the study further establish caffeine's potential ergogenic benefit on measures of muscular strength.",2020,MIP and PP improved after ingestion of caffeine compared to the placebo condition.,"['Fifteen (8 male, 7 female) healthy adults (mean\u2009±\u2009SD: age\u2009=\u200924.3\u2009±\u20096.4 years; height\u2009=\u20091.75\u2009±\u20090.11\u2005m; body mass\u2009=\u200978.8\u2009±\u200916.5\u2005kg) volunteered to participate in the study which used a double-blind']","['Caffeine', 'placebo', 'caffeine (CAF) or placebo capsule (PL', 'caffeine']","['Inspiratory Muscle Function', 'MIP', 'MRPD', 'maximal inspiratory pressure (MIP', 'inspiratory muscle function', 'muscular strength', 'MIP and PP', 'MIP, maximal inspiratory peak pressure (PP), and maximal rate of pressure development (MRPD']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517425', 'cui_str': '0.11 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0243107', 'cui_str': 'development'}]",12.0,0.0703862,MIP and PP improved after ingestion of caffeine compared to the placebo condition.,"[{'ForeName': 'Clayton R', 'Initials': 'CR', 'LastName': 'Nicks', 'Affiliation': 'Department of Kinesiology and Health Sciences, Human Performance Laboratory, Columbus State University, Columbus, GA, USA.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'Martin', 'Affiliation': 'Department of Kinesiology and Health Sciences, Human Performance Laboratory, Columbus State University, Columbus, GA, USA.'}]",European journal of sport science,['10.1080/17461391.2019.1675767']
879,31604060,Is Low-Level Laser Therapy Effective for Pain Control After the Surgical Removal of Unerupted Third Molars? A Randomized Trial.,"PURPOSE


One of the main challenges after extraction of unerupted third molars is pain control, and one of the treatments for pain control is low-level laser therapy (LLLT). Thus, this study aimed to assess the effectiveness of LLLT for pain control after extraction of lower third molars.
MATERIALS AND METHODS


This randomized, double-blind, split-mouth study included patients who required bilateral extraction of unerupted lower third molars. Patients received LLLT on 1 side (laser group) but not on the opposite side (control group). On the experimental side, each patient received a laser application at 5 intraoral points for 30 seconds per point. This procedure was simulated on the control side. The pain control response was assessed with a modified pain visual analog scale at the following times: immediately after surgery (T0), after laser application (T1), 24 hours after surgery (T2), 48 hours after surgery (T3), and 72 hours after surgery (T4).
RESULTS


Thirty-two patients, 56.25% of whom were women, underwent extraction; the average age was 22.2 years. At the times analyzed, the laser group presented better results than the control group. As for the times, there were differences in pain scores between T0 (8.03 ± 14.87) and T3 (2.66 ± 4.23), as well as T4 (3.36 ± 7.83), in the laser group and differences between T0 (19.76 ± 26.66) and T3 (7.11 ± 10.76), as well as T4 (6.26 ± 13.14), in the control group.
CONCLUSION


LLLT was effective in reducing pain after surgical removal of unerupted third molars. At T3 and T4, pain reduction in relation to T0 was noted in both groups.",2020,"At T3 and T4, pain reduction in relation to T0 was noted in both groups.","['Thirty-two patients, 56.25% of whom were women, underwent extraction; the average age was 22.2\xa0years', 'patients who required bilateral extraction of unerupted lower third molars']",['LLLT'],"['pain scores', 'Pain Control', 'pain', 'modified pain visual analog scale', 'pain control response']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C4019433', 'cui_str': 'LLLT'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",32.0,0.181256,"At T3 and T4, pain reduction in relation to T0 was noted in both groups.","[{'ForeName': 'Pâmela Letícia', 'Initials': 'PL', 'LastName': 'Santos', 'Affiliation': 'Assistant Professor, Department of Health Sciences, Implantology Post Graduation Course, Dental School, University of Araraquara, Araraquara, Brazil. Electronic address: pamelalsantos@hotmail.com.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Marotto', 'Affiliation': 'Surgeon-Dentist, Department of Health Sciences, University of Araraquara (UNIARA), Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Thaiz', 'Initials': 'T', 'LastName': 'Zatta da Silva', 'Affiliation': 'Department of Health Sciences, University of Araraquara (UNIARA), Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Mariele Pecorali', 'Initials': 'MP', 'LastName': 'Bottura', 'Affiliation': 'Surgeon-Dentist, Department of Health Sciences, University of Araraquara (UNIARA), Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Valencise', 'Affiliation': 'Surgeon-Dentist, Department of Health Sciences, University of Araraquara (UNIARA), Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Daniela Oliveira', 'Initials': 'DO', 'LastName': 'Marques', 'Affiliation': 'Department of Health Sciences, University of Araraquara (UNIARA), Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Thallita Pereira', 'Initials': 'TP', 'LastName': 'Queiroz', 'Affiliation': 'Assistant Professor, Department of Health Sciences, Implantology Post Graduation Course, Dental School, University of Araraquara, Araraquara, Brazil.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.08.029']
880,29274618,The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer.,"BACKGROUND


In the phase III RECOURSE trial, trifluridine/tipiracil (TAS-102) extended overall survival (OS) and progression-free survival (PFS) with an acceptable toxicity profile in patients with metastatic colorectal cancer refractory or intolerant to standard therapies. The present analysis investigated the efficacy and safety of trifluridine/tipiracil in RECOURSE subgroups.
METHODS


Primary and key secondary end-points were evaluated using a Cox proportional hazards model in prespecified subgroups, including geographical subregion (United States of America [USA], European Union [EU], Japan), age (<65 years, ≥65 years) and v-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homologue (KRAS) status (wild type, mutant). Safety and tolerability were reported with descriptive statistics.
RESULTS


Eight-hundred patients were enrolled: USA, n = 99; EU, n = 403; Japan, n = 266. Patients aged ≥65 years and those with mutant KRAS tumours comprised 44% and 51% of all patients in the subregions, respectively. Final OS analysis (including 89% of events, compared with 72% in the initial analysis) confirmed the survival benefit associated with trifluridine/tipiracil, with a hazard ratio (HR) of 0.69 (95% confidence interval [CI] 0.59-0.81; P = 0.0001). Median OS in the three regions was 6.5-7.8 months in the trifluridine/tipiracil arm and 4.3-6.7 months in the placebo arm (USA: HR 0.56; 95% CI 0.34-0.94; P = 0.0277; EU: HR 0.62; 95% CI 0.48-0.80; P = 0.0002; Japan: HR 0.75; 95% CI 0.57-1.00; P = 0.0470). Median PFS was 2.0-2.8 months for trifluridine/tipiracil and 1.7-1.8 months for placebo; HRs favoured trifluridine/tipiracil in all regions. Similar clinical benefits of trifluridine/tipiracil were observed in elderly patients and in those with mutant KRAS tumours. There were no marked differences among subregions in terms of safety and tolerability.
CONCLUSIONS


Trifluridine/tipiracil was effective in all subgroups, regardless of age, geographical origin or KRAS status. This trial is registered with ClinicalTrials.gov: NCT01607957.",2018,"Final OS analysis (including 89% of events, compared with 72% in the initial analysis) confirmed the survival benefit associated with trifluridine/tipiracil, with a hazard ratio (HR) of 0.69 (95% confidence interval [CI] 0.59-0.81; P = 0.0001). ","['Patients aged ≥65 years and those with mutant KRAS tumours', 'patients with metastatic colorectal cancer', ' age (<65 years, ≥65 years) and v-Ki-ras2 Kirsten rat sarcoma 2 viral oncogene homologue (KRAS) status (wild type, mutant', 'patients with metastatic colorectal cancer refractory or intolerant to standard therapies', 'elderly patients and in those with mutant KRAS tumours', 'Eight-hundred patients were enrolled: USA, n\xa0=\xa099; EU, n\xa0=\xa0403; Japan, n\xa0=\xa0266']","['Trifluridine/tipiracil', 'trifluridine/tipiracil (TAS-102) versus placebo', 'placebo', 'trifluridine/tipiracil']","['safety and tolerability', 'geographical subregion (United States of America [USA], European Union [EU], Japan', 'survival benefit', 'Median OS', 'efficacy and safety', 'overall survival (OS) and progression-free survival (PFS', 'Safety and tolerability', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}, {'cui': 'C0029016', 'cui_str': 'Transforming Genes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",800.0,0.390377,"Final OS analysis (including 89% of events, compared with 72% in the initial analysis) confirmed the survival benefit associated with trifluridine/tipiracil, with a hazard ratio (HR) of 0.69 (95% confidence interval [CI] 0.59-0.81; P = 0.0001). ","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospital Gasthuisberg, Digestive Oncology, Herestraat 49, 3000 Leuven, Belgium; KU Leuven, Oude Markt 13, 3000 Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215, USA. Electronic address: Robert_Mayer@dfci.harvard.edu.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'University Hospital Ghent, De Pintelaan 185, 9000 Gent, Belgium. Electronic address: STEPHANIE.LAURENT@UGent.be.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Winkler', 'Affiliation': 'Taiho Oncology, Inc., 101 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: rwinkler@taihooncology.com.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Grávalos', 'Affiliation': 'Hospital Universitario 12 de Octubre, Avenida de Córdoba s/n, 28041 Madrid, Spain. Electronic address: cgravalos@telefonica.net.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Benavides', 'Affiliation': 'Hospital Regional Universitario de Málaga, Avenida de Carlos Haya s/n, 29011 Málaga, Spain. Electronic address: manuel.benavides.sspa@juntadeandalucia.es.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Longo-Munoz', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo, Km.9,100, 28034 Madrid, Spain. Electronic address: fedelongomunoz@hotmail.com.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': ""CRLC Val d'Aurelle, 208 Avenue des Apothicaires, 34298 Montpellier, France. Electronic address: Fabienne.Portales@icm.unicancer.fr.""}, {'ForeName': 'Fortunato', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': 'Seconda Università degli Studi di Napoli, Via Antonio Vivaldi, 43, 81100 Caserta, Italy. Electronic address: fortunatociardiello@yahoo.com.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Siena', 'Affiliation': ""Università degli Studi di Milano, Via Festa del Perdono, 7, 20122 Milan, Italy; Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore, 3, 20162 Milan, Italy. Electronic address: salvatore.siena@ospedaleniguarda.it.""}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ward, Tokyo, 135-8550, Japan. Electronic address: kensei.yamaguchi@jfcr.or.jp.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. Electronic address: kmuro@aichi-cc.jp.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Chiba Cancer Center, 666-2 Nitona-Cho, Chuo-ku, Chiba, 260-8717, Japan. Electronic address: tdenda@chiba-cc.jp.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Tonan Hospital, N1 W6 Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan. Electronic address: ytsuji@tonan.gr.jp.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Makris', 'Affiliation': 'Stathmi, Inc., 125 Brownsburg Rd, New Hope, PA 18938-9239, USA. Electronic address: lmakris@taihooncology.com.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Loehrer', 'Affiliation': 'Indiana University Melvin and Bren Simon Cancer Center, 535 Barnhill Dr, Indianapolis, IN 46202, USA. Electronic address: ploehrer@iu.edu.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'USC Norris Comprehensive Cancer Center, 1441 Eastlake Ave, Los Angeles, CA 90089, USA. Electronic address: LENZ@med.usc.edu.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. Electronic address: aohtsu@east.ncc.go.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2017.10.009']
881,31523057,Understanding of prognosis in non-metastatic prostate cancer: a randomised comparative study of clinician estimates measured against the PREDICT prostate prognostic model.,"PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ). In this study clinician estimates of survival were compared against model predictions and its potential value as a clinical tool was assessed. Prostate cancer (PCa) specialists were invited to participate in the study. 190 clinicians (63% urologists, 17% oncologists, 20% other) were randomised into two groups and shown 12 clinical vignettes through an online portal. Each group viewed opposing vignettes with clinical information alone, or alongside PREDICT Prostate estimates. 15-year clinician survival estimates were compared against model predictions and reported treatment recommendations with and without seeing PREDICT estimates were compared. 155 respondents (81.6%) reported counselling new PCa patients at least weekly. Clinician estimates of PCa-specific mortality exceeded PREDICT estimates in 10/12 vignettes. Their estimates for treatment survival benefit at 15 years were over-optimistic in every vignette, with mean clinician estimates more than 5-fold higher than PREDICT Prostate estimates. Concomitantly seeing PREDICT Prostate estimates led to significantly lower reported likelihoods of recommending radical treatment in 7/12 (58%) vignettes, particularly in older patients. These data suggest clinicians overestimate cancer-related mortality and radical treatment benefit. Using an individualised prognostic tool may help reduce overtreatment.",2019,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"['non-metastatic prostate cancer', 'Prostate cancer (PCa) specialists', 'men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ', '190 clinicians (63% urologists, 17% oncologists, 20% other']",[],"['PCa-specific mortality', '15-year clinician survival estimates']","[{'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0260314', 'cui_str': 'Urologists'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",[],"[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0282638,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thurtle', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK. dt433@cam.ac.uk.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jenkins', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer, University of Sussex, Brighton, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Pharoah', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}]",British journal of cancer,['10.1038/s41416-019-0569-4']
882,31628482,"A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis.","OBJECTIVES


3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease activity.
METHODS


We conducted a randomized double-blind placebo-controlled 12 week trial of lovastatin vs placebo in 64 RA patients with mild clinical disease activity but an elevated CRP. The primary efficacy end point was the reduction in mean log CRP. Secondary end points included disease activity, RF and anti-CCP antibody titres. Mechanistic end points included levels of serum cytokines. Safety was assessed; hepatic and muscle toxicities were of particular interest.
RESULTS


Baseline features were similar between groups. No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group. Mechanistic analyses did not reveal significant changes in any biomarkers. A post hoc analysis of subjects not using biologic therapy demonstrated a significantly greater proportion achieving ⩾20% reduction in CRP from baseline in the lovastatin group compared with placebo (P-value = 0.007). No difference was observed in subjects receiving biologics. Lovastatin was well tolerated with no serious safety concerns.
CONCLUSION


This study showed no anti-inflammatory or clinical effects on RA disease activity after 12 weeks of treatment with lovastatin. Lovastatin had a modest effect on CRP in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT00302952.",2020,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","['mildly active rheumatoid arthritis', 'hyperlipidaemia', 'patients with RA with', '64 RA patients with mild clinical disease activity but an elevated CRP']","['lovastatin', '3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins', 'lovastatin therapy', 'placebo', 'lovastatin vs placebo', 'Lovastatin']","['mean log CRP', 'CRP', 'hepatic and muscle toxicities', 'mean log CRP reduction', 'disease activity, RF and anti-CCP antibody titres', 'RA disease activity', 'disease activity', 'levels of serum cytokines']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4318437', 'cui_str': 'Anti-CCP'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.344131,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cush', 'Affiliation': 'Division of Rheumatology, Baylor University Medical Center, Dallas, USA.'}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': 'Division of Rheumatology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Striebich', 'Affiliation': 'Division of Rheumatology, University of Colorado, Denver, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""Dall'era"", 'Affiliation': 'Division of Rheumatology, University of California, San Francisco, USA.'}, {'ForeName': 'Meggan', 'Initials': 'M', 'LastName': 'Mackay', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Olech', 'Affiliation': 'Department of Internal Medicine, University of Nevada School of Medicine, Las Vegas, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Internal Medicine, University of Utah, Internal Medicine, Salt Lake City, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Box', 'Affiliation': 'Box Arthritis & Rheumatology of the Carolinas, Charlotte, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keating', 'Affiliation': 'Division of Rheumatology, Scripps Green Hospital, La Jolla, USA.'}, {'ForeName': 'Mary Chester', 'Initials': 'MC', 'LastName': 'Wasko', 'Affiliation': 'Division of Rheumatology, Western Pennsylvania Hospital, Pittsburgh, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'St Clair', 'Affiliation': 'Division of Rheumatology and Immunology, Duke University School of Medicine, Durham, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Weiquang', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'PetaGay', 'Initials': 'P', 'LastName': 'Ricketts', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Welch', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Spychala', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'York', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez471']
883,31860533,Listening to Fast-Tempo Music Delays the Onset of Neuromuscular Fatigue.,"Centala, J, Pogorel, C, Pummill, SW, and Malek, MH. Listening to fast-tempo music delays the onset of neuromuscular fatigue. J Strength Cond Res 34(3): 617-622, 2020-Studies determining the effect of music on physical performance have primarily focused on outcomes such as running time to exhaustion, blood lactate, or maximal oxygen uptake. The electromyographic fatigue threshold (EMGFT) is determined through a single incremental test and operationally defined as the highest exercise intensity that can be sustained indefinitely without an increase in EMG activity of the working muscle. To date, no studies have examined the role of fast-tempo music on EMGFT. The purpose of this investigation, therefore, was to determine whether fast-tempo music attenuates neuromuscular fatigue as measured by the EMGFT. We hypothesized that listening to fast-tempo music during exercise would increase the estimated EMGFT compared with the control condition. Secondarily, we hypothesized that maximal power output would also increase as a result of listening to fast-tempo music during the exercise workbout. Ten healthy college-aged men (mean ± SEM: age, 25.3 ± 0.8 years [range from 22 to 31 years]; body mass, 78.3 ± 1.8 kg; height: 1.77 ± 0.02 m) visited the laboratory on 2 occasions separated by 7 days. The EMGFT was determined from an incremental single-leg knee-extensor ergometer for each visit. In a randomized order, subjects either listened to music or no music for the 2 visits. All music was presented as instrumentals and randomized with a tempo ranging between 137 and 160 b·min. The results indicated that listening to fast-tempo music during exercise increased maximal power output (No Music: 48 ± 4; Music: 54 ± 3 W; p = 0.02) and EMGFT (No Music: 27 ± 3; Music: 34 ± 4 W; p = 0.008). There were, however, no significant mean differences between the 2 conditions (no music vs. music) for absolute and relative end-exercise heart rate as well as end-exercise rating of perceived exertion for the exercised leg. These findings suggest that listening to fast-tempo music increased overall exercise tolerance as well as the neuromuscular fatigue threshold. The results are applicable to both sport and rehabilitative settings.",2020,No Music: 27 ± 3; Music: 34 ± 4 W; p = 0.008).,"['Ten healthy college-aged men (mean ± SEM: age, 25.3 ± 0.8 years [range from 22 to 31 years]; body mass, 78.3 ± 1.8 kg; height: 1.77 ± 0.02 m) visited the laboratory on 2 occasions separated by 7 days']","['J Strength Cond Res XX(X', 'listened to music or no music', 'EMGFT ']","['running time to exhaustion, blood lactate, or maximal oxygen uptake', 'overall exercise tolerance', 'absolute and relative end-exercise heart rate as well as end-exercise rating of perceived exertion for the exercised leg', 'EMG activity', 'electromyographic fatigue threshold (EMGFT', 'maximal power output']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}]",10.0,0.0958458,No Music: 27 ± 3; Music: 34 ± 4 W; p = 0.008).,"[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Centala', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Pogorel', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Pummill', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}, {'ForeName': 'Moh H', 'Initials': 'MH', 'LastName': 'Malek', 'Affiliation': 'Physical Therapy Program, Department of Health Care Sciences, Wayne State University, College of Pharmacy and Health Sciences, Detroit, Michigan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003417']
884,31634877,"Medication Management Program: Adherence, Disease-related Knowledge, Health-related Quality of Life, and Glycemic Control for Type 2 Diabetes Mellitus.","Context


Escalation in rates of diabetes in Pakistan is posing threats to the economy and to the people's quality of life due to poor glycemic control and very high rates of complications. Cost of care is very high, and many barriers to quality care exist. Most often patients are unable to afford the high cost of treatment. Patients' knowledge about diabetes is associated with better medication adherence and better glycemic control.
Objective


The current study intended to evaluate the effects of an educational intervention in a pharmacist led, medication management program (MTM) tailored for patients with type 2 diabetes (T2DM).
Design


The research team conducted a nonclinical, randomized controlled trial.
Setting


The study took place at District Headquarters and Teaching Hospital, a public-sector hospital (Sargodha, Pakistan).
Participants


Participants were 392 individuals with T2DM.
Intervention


Participants were randomly assigned to one of 2 groups-intervention and control-with 196 patients in each. The intervention group, instead of receiving standard care, received pharmaceutical care through the Medication Therapy Management program, whereas the control group received standard care.
Outcome Measures


At baseline and 3 mo post ntervention, the study assessed participants' diabetes-related knowledge, medication adherence, and health-related quality of life (HRQoL) using the 14-item Michigan Diabetes Knowledge Test, the 8-item Morisky Medication Adherence Scale, and the European Quality of Life scales, respectively. To determine glycemic control, participants' baseline HbA1c levels were taken from their medical records, and the final HbA1c result was obtained postintervention.
Results


For the intervention and control groups at baseline, diabetes-related knowledge was average, at 7.99 ± 2.65 and 8.03 ± 2.49, respectively; medication adherence was low, at 4.54 ± 1.69 and 4.41 ± 1.84, respectively; and glycemic control was poor, at 9.47 ± 1.57 and 9.41 ± 1.57, respectively. After the educational intervention, the intervention group had increased its diabetes-related knowledge, medication adherence, and HRQoL scores, with the results being 10.55 ± 2.56, 5.24 ± 1.48, and 0.6115 ± 0.286, respectively. The group's glycemic control has also improved to 8.97 ± 1.362. A statistically significant difference between the groups had occurred, with P < .001. The control group's scores had remained approximately the same for medication adherence, HRQoL, and glycemic control, and little difference had occurred as compared with the group's baseline analysis.
Conclusion


The study found that the educational program increased the intervention group's level of diabetes-related knowledge, and improved its adherence to medication and its glycemic control, all due to its improved HRQoL. Patients' beliefs about the effects of long-term use of medicines were also addressed by the MTM program. The program was successful because it decreased participants' HbA1c values, which is a positive indicator of successful T2DM therapy.",2020,"After the educational intervention, the intervention group had increased its diabetes-related knowledge, medication adherence, and HRQoL scores, with the results being 10.55 ± 2.56, 5.24 ± 1.48, and 0.6115 ± 0.286, respectively.","['Setting\n\n\nThe study took place at District Headquarters and Teaching Hospital, a public-sector hospital (Sargodha, Pakistan', 'patients with type 2 diabetes (T2DM', 'Participants\n\n\nParticipants were 392 individuals with T2DM']","['receiving standard care, received pharmaceutical care through the Medication Therapy Management program, whereas the control group received standard care', 'medication management program (MTM', 'educational intervention', 'Medication Management Program']","['medication adherence', 'diabetes-related knowledge, medication adherence, and HRQoL scores', 'Adherence, Disease-related Knowledge, Health-related Quality of Life, and Glycemic Control', 'glycemic control', 'diabetes-related knowledge, medication adherence, and health-related quality of life (HRQoL) using the 14-item Michigan Diabetes Knowledge Test, the 8-item Morisky Medication Adherence Scale, and the European Quality of Life scales', 'medication adherence, HRQoL, and glycemic control']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}]",392.0,0.026022,"After the educational intervention, the intervention group had increased its diabetes-related knowledge, medication adherence, and HRQoL scores, with the results being 10.55 ± 2.56, 5.24 ± 1.48, and 0.6115 ± 0.286, respectively.","[{'ForeName': 'Saeed Ur Rashid', 'Initials': 'SUR', 'LastName': 'Nazir', 'Affiliation': ''}, {'ForeName': 'Mohamed Azmi', 'Initials': 'MA', 'LastName': 'Hassali', 'Affiliation': ''}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Saleem', 'Affiliation': ''}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Haque', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
885,31876673,Heavy Resistance Training in Breast Cancer Patients Undergoing Adjuvant Therapy.,"BACKGROUND AND PURPOSE


Adjuvant breast cancer therapy may reduce maximal muscle strength, muscle mass, and functional performance. Although maximal strength training (MST) has the potential to counteract this debilitating outcome and is shown to be superior to low- and moderate-intensity strength training, it is unknown if it can elicit effective adaptations in patients suffering treatment-induced adverse side effects.
METHODS


Fifty-five newly diagnosed stage I to III breast cancer patients (49 ± 7 yr) scheduled for adjuvant therapy were randomized to MST or a control group. The MST group performed 4 × 4 repetitions of dynamic leg press at approximately 90% of one-repetition maximum (1RM) twice a week for 12 wk.
RESULTS


In the MST group, improvements in 1RM (20% ± 8%; P < 0.001) were accompanied by improved walking economy (9% ± 8%) and increased time to exhaustion during incremental walking (9% ± 8%; both P < 0.01). Moreover, the MST group increased 6-min walking distance (6MWD; 10% ± 7%), and chair rising (30% ± 20%) and stair climbing performance (12% ± 7%; all P < 0.001). All MST-induced improvements were different from the control group (P < 0.01) which reduced their 1RM (9% ± 5%), walking economy (4% ± 4%), time to exhaustion (10% ± 8%), 6MWD (5% ± 5%), chair rising performance (12% ± 12%), and stair climbing performance (6% ± 8%; all P < 0.01). Finally, although MST maintained estimated quadriceps femoris muscle mass, a decrease was observed in the control group (7% ± 10%; P < 0.001). The change in 1RM correlated with the change in walking economy (r = 0.754), time to exhaustion (r = 0.793), 6MWD (r = 0.807), chair rising performance (r = 0.808), and stair climbing performance (r = 0.754; all P < 0.001).
CONCLUSIONS


Lower-extremity MST effectively increases lower-extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass. These results advocate that MST should be considered in breast cancer treatment.",2020,"Lower extremity MST effectively increases lower extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass.","['Fifty-five newly diagnosed stage', 'Breast Cancer Patients Undergoing Adjuvant Therapy', 'breast cancer patients undergoing', 'patients suffering treatment-induced adverse side effects', 'I-III breast cancer patients (49±7 years) scheduled for adjuvant therapy']","['adjuvant therapy', 'MST', 'maximal strength training (MST', 'Heavy Resistance Training']","['1RM', '6 minutes walking distance (6MWD; 10±7%), and chair rising', 'work economy, functional performance, and maintenance of muscle mass', 'quadriceps femoris muscle mass', 'change in 1RM', 'time to exhaustion', 'maximal muscle strength, muscle mass, and functional performance', 'time to exhaustion (10±8%), 6MWD (5±5%), chair rising performance', 'walking economy', 'stair climbing performance', 'time to exhaustion (r=0.793), 6MWD (r=0.807), chair rising performance (r=0.808), and stair climbing performance', 'extremity maximal muscle strength']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3853978'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]",55.0,0.0130742,"Lower extremity MST effectively increases lower extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass.","[{'ForeName': 'Rūdolfs', 'Initials': 'R', 'LastName': 'Cešeiko', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Simon Nørskov', 'Initials': 'SN', 'LastName': 'Thomsen', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, DENMARK.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Tomsone', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Jānis', 'Initials': 'J', 'LastName': 'Eglītis', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Aivars', 'Initials': 'A', 'LastName': 'Vētra', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Srebnijs', 'Affiliation': 'Faculty of Medicine, University of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Mihails', 'Initials': 'M', 'LastName': 'Timofejevs', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Egīls', 'Initials': 'E', 'LastName': 'Purmalis', 'Affiliation': 'The Oncology Centre of Latvia, Rīga, LATVIA.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Rīga Stradiņš University, Rīga, LATVIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002260']
886,31624837,Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR).,"OBJECTIVE


To examine the effects of filgotinib, an oral, selective Janus kinase 1 inhibitor, on health-related quality of life (HRQoL) using the Psoriatic Arthritis Impact of Disease (PsAID)9 questionnaire in active PsA.
METHODS


Patients were randomized 1 : 1 to filgotinib 200 mg or placebo once daily for 16 weeks in EQUATOR, a multicentre, double-blind, phase 2 randomized controlled trial. HRQoL was assessed with PsAID9 at Weeks 4 and 16. Change from baseline in total and individual domain scores, plus the proportions of patients achieving minimal clinically important improvement (MCII; ⩾3 points) and patient-accepted symptom status (PASS; score <4), were evaluated. Correlation with the 36-item short-form health survey (SF-36) was investigated.
RESULTS


One hundred and thirty-one patients were randomized to filgotinib or placebo. Filgotinib effects on PsAID9 were observed from Week 4. At Week 16, mean (s.d.) change from baseline in PsAID9 was -2.3 (1.8) and -0.8 (2.2) for filgotinib and placebo, respectively (least-squares mean of group difference -1.48 [95% CI -2.12, -0.84], P < 0.0001), with significant improvements in all domains vs placebo. Significantly more patients on filgotinib achieved MCII (group difference 25.4% [95% CI 8.92, 39.99], P = 0.0022) and PASS (group difference 29.6% [95% CI 10.65, 45.60], P = 0.0018) at Week 16 vs placebo. Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36.
CONCLUSION


Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9. To our knowledge, EQUATOR is the first randomized controlled trial to evaluate PsAID9.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show, NCT03101670.",2020,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36.
CONCLUSION


Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","['Patients', 'One hundred and thirty-one patients', 'active psoriatic arthritis', 'patients with active PsA']","['placebo', 'filgotinib', 'filgotinib or placebo', 'filgotinib 200 mg or placebo']","['HRQoL', 'health-related quality of life', 'PsAID9', 'SF-36', 'filgotinib achieved MCII']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}]",131.0,0.800834,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36.
CONCLUSION


Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Rheumatology, Royal National Hospital for Rheumatic Diseases.'}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Department of Rheumatology & Immunology, Singapore General Hospital, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Meuleners', 'Affiliation': 'Biostatistics, Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Hendrikx', 'Affiliation': 'Medical Affairs, Galapagos BV, Leiden, Netherlands.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez408']
887,30893292,Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Long-term Follow-up From the Randomized SCHEDULE Study.,"BACKGROUND


A calcineurin inhibitor (CNI)-free immunosuppressive regimen has been demonstrated to improve renal function early after heart transplantation, but long-term outcome of such a strategy has not been well described.
METHODS


In the randomized SCHEDULE trial, de novo heart transplant recipients received (1) everolimus with reduced-exposure CNI (cyclosporine) followed by CNI withdrawal at week 7-11 posttransplant or (2) standard-exposure cyclosporine, both with mycophenolate mofetil and corticosteroids; 95/115 randomized patients were followed up at 5-7 years posttransplant.
RESULTS


Mean measured glomerular filtration rate was 74.7 mL/min and 62.4 mL/min with everolimus and CNI, respectively. The mean difference was in favor of everolimus by 11.8 mL/min in the intent-to-treat population (P = 0.004) and 17.2 mL/min in the per protocol population (n = 75; P < 0.001). From transplantation to last follow-up, the incidence of biopsy-proven acute rejection (BPAR) was 77% (37/48) and 66% (31/47) (P = 0.23) with treated BPAR in 50% and 23% (P < 0.01) in the everolimus and CNI groups, respectively; no episode led to hemodynamic compromise. Coronary allograft vasculopathy (CAV) assessed by coronary intravascular ultrasound was present in 53% (19/36) and 74% (26/35) of everolimus- and CNI-treated patients, respectively (P = 0.037). Graft dimensions and function were similar between the groups. Late adverse events were comparable.
CONCLUSIONS


These results suggest that de novo heart transplant patients randomized to everolimus and low-dose CNI followed by CNI-free therapy maintain significantly better long-term renal function as well as significantly reduced CAV than patients randomized to standard CNI treatment. Increased BPAR in the everolimus group during year 1 did not impair long-term graft function.",2020,"Coronary allograft vasculopathy (CAV) assessed by coronary intravascular ultrasound was present in 53% (19/36) and 74% (26/35) of everolimus- and CNI-treated patients, respectively (P = 0.037).",['De Novo Heart Transplant Recipients'],"['everolimus', 'everolimus with reduced-exposure calcineurin inhibitor (CNI, cyclosporine) followed by CNI withdrawal at weeks 7-11 post-transplant or (2) standard-exposure cyclosporine, both with mycophenolate mofetil and corticosteroids', 'Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal']","['Graft dimensions and function', 'Increased BPAR', 'Late adverse events', 'Coronary allograft vasculopathy (CAV) assessed by coronary intravascular ultrasound', 'incidence of biopsy-proven acute rejection (BPAR', 'Mean measured GFR']","[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",,0.0415711,"Coronary allograft vasculopathy (CAV) assessed by coronary intravascular ultrasound was present in 53% (19/36) and 74% (26/35) of everolimus- and CNI-treated patients, respectively (P = 0.037).","[{'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Arne K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Andersson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Rådegran', 'Affiliation': 'Section for Heart Failure and Valvular Disease, Skåne University Hospital and Department of Clinical Sciences, Cardiology, Lund University, Lund Sweden.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Jansson', 'Affiliation': 'Department of Cardiology, Heart and Medicine Center County Council of Ostergotland and Linkoping University, Linkoping, Sweden.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Solbu', 'Affiliation': 'Novartis Norge AS, Oslo, Norway.'}, {'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000002702']
888,31472246,Different exercise modalities relieve pain syndrome in patients with knee osteoarthritis and modulate the dorsolateral prefrontal cortex: A multiple mode MRI study.,"OBJECTIVES


Knee osteoarthritis (KOA) is a common degenerative joint disease with no satisfactory intervention. Recently, both physical and mindfulness exercises have received considerable attention for their implications in KOA pain management, and the dorsolateral prefrontal cortex (DLPFC) has displayed a critical role in pain modulation. This study aimed to comparatively investigate the modulation effects of different exercises using multidisciplinary measurements.
METHODS


140 KOA patients were randomized into Tai Chi, Baduanjin, stationary cycling, or health education control groups for 12 weeks. Knee Injury and Osteoarthritis Outcome Score (KOOS), resting state functional magnetic resonance imaging (fMRI), structural MRI, and serum biomarkers were measured at baseline and at the end of the study.
RESULTS


We found: 1) increased KOOS pain subscores (pain reduction) and serum programmed cell death protein 1 (PD-1) levels in the three exercise groups compared to the control group; 2) decreased resting state functional connectivity (rsFC) of the DLPFC-supplementary motor area (SMA) and increased rsFC between the DLPFC and anterior cingulate cortex in all exercise groups compared to the control group; 3) significant associations between DLPFC-SMA rsFC with KOOS pain subscores and serum PD-1 levels at baseline; 4) significantly increased grey matter volume in the SMA in the Tai Chi and stationary cycling groups, and a trend toward significant increase in the Baduanjin group compared to the control group; 5) significant DLPFC rsFC differences among different exercise groups; and 6) that baseline DLPFC-SMA rsFC can predict the effect of mind-body exercise on pain improvement in KOA.
CONCLUSION


Our results suggest that different exercises can modulate both common and unique DLPFC (cognitive control) pathways, and altered DLPFC-SMA rsFC is associated with serum biomarker levels. Our findings also highlight the potentials of neuroimaging biomarkers in predicting the therapeutic effect of mind-body exercises on KOA pain.",2019,"We found: 1) increased KOOS pain subscores (pain reduction) and serum programmed cell death protein 1 (PD-1) levels in the three exercise groups compared to the control group; 2) decreased resting state functional connectivity (rsFC) of the DLPFC-supplementary motor area (SMA) and increased rsFC between the DLPFC and anterior cingulate cortex in all exercise groups compared to the control group; 3) significant associations between DLPFC-SMA rsFC with KOOS pain subscores and serum PD-1 levels at baseline; 4) significantly increased grey matter volume in the SMA in the Tai Chi and stationary cycling groups, and a trend towards significant increase in the Baduanjin group compared to the control group; 5) significant DLPFC rsFC differences among different exercise groups; and 6) that baseline DLPFC-SMA rsFC can predict the effect of mind-body exercise on pain improvement in KOA.
","['Knee osteoarthritis (KOA', 'patients with knee osteoarthritis and modulate the dorsolateral prefrontal cortex', '140 KOA patients']","['Different exercise modalities', 'Tai Chi, Baduanjin, stationary cycling, or health education control']","['DLPFC-SMA rsFC with KOOS pain subscores and serum PD-1 levels', 'KOOS pain subscores (pain reduction) and serum programmed cell death protein 1 (PD-1) levels', 'pain improvement', 'pain syndrome', 'Knee Injury and Osteoarthritis Outcome Score (KOOS), resting state functional magnetic resonance imaging (fMRI), structural MRI, and serum biomarkers', 'grey matter volume', 'resting state functional connectivity (rsFC) of the DLPFC-supplementary motor area (SMA) and increased rsFC between the DLPFC and anterior cingulate cortex']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1564881', 'cui_str': 'Apoptosis Regulatory Proteins'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}]",,0.0191605,"We found: 1) increased KOOS pain subscores (pain reduction) and serum programmed cell death protein 1 (PD-1) levels in the three exercise groups compared to the control group; 2) decreased resting state functional connectivity (rsFC) of the DLPFC-supplementary motor area (SMA) and increased rsFC between the DLPFC and anterior cingulate cortex in all exercise groups compared to the control group; 3) significant associations between DLPFC-SMA rsFC with KOOS pain subscores and serum PD-1 levels at baseline; 4) significantly increased grey matter volume in the SMA in the Tai Chi and stationary cycling groups, and a trend towards significant increase in the Baduanjin group compared to the control group; 5) significant DLPFC rsFC differences among different exercise groups; and 6) that baseline DLPFC-SMA rsFC can predict the effect of mind-body exercise on pain improvement in KOA.
","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'National-Local Joint Engineering Research Center of Rehabilitation Medicine Technology, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China; College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China; Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Xiangli', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Psychology and Special Education, University of Wisconsin-Madison, 53706, USA.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Youxue', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Meiqin', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Guanli', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Shanjia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Weilin', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Tianshen', 'Initials': 'T', 'LastName': 'Xiao', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'National-Local Joint Engineering Research Center of Rehabilitation Medicine Technology, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China; College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China; Traditional Chinese Medicine Rehabilitation Research Center of State Administration of Traditional Chinese Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350122, China. Electronic address: taojing01@163.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Charlestown, MA 02129, USA.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.08.193']
889,31364889,Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms.,"Objective:  This study aimed to evaluate the effects of TX-001HR (17β-estradiol [E2] and progesterone [P4] in a single oral capsule) on cardiometabolic markers and outcomes.  Methods:  Four E2/P4 doses (1 mg/100 mg, 0.5 mg/100 mg, 0.5 mg/50 mg, 0.25 mg/50 mg) were compared with placebo in menopausal women with vasomotor symptoms (VMS) and a uterus in the phase 3 REPLENISH (ClinicalTrials.gov, NCT01942668) trial. Changes in lipid and coagulation parameters and blood glucose from baseline at 6, 9, and 12 months as well as cardiovascular events are summarized.  Results:  A total of 1835 participants took ≥1 capsule of daily E2/P4; 1684 received E2/P4 and 151 received placebo. No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups. Minimal increases of potential clinical importance were observed in total cholesterol, triglycerides, and glucose at month 12 with E2/P4 (1-4%, 6-11%, and 1%, respectively) and placebo (3%, 7%, and 2%, respectively). One episode of deep venous thrombosis and three cases of cardiovascular disease were observed, similar to expected rates of these events in the general population.  Conclusions:  In the REPLENISH trial, postmenopausal women with VMS treated with E2/P4 had no clinically meaningful effects on lipids, glucose, or coagulation parameters compared with placebo.",2019,"No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups.","['menopausal women with vasomotor symptoms', 'menopausal women with vasomotor symptoms (VMS', '1835 participants took ≥1 capsule of daily E2/P4; 1684 received E2/P4 and 151 received', 'postmenopausal women with VMS treated with E2/P4']","['placebo', 'TX-001HR (17β-estradiol [E2] and progesterone [P4', 'TX-001HR']","['cardiovascular disease', 'lipid and coagulation parameters and blood glucose', 'total cholesterol, triglycerides, and glucose', 'lipid parameters, coagulation factors, or glucose', 'lipids, glucose, or coagulation parameters', 'cardiometabolic markers and outcomes', 'potential clinical importance']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1167912', 'cui_str': 'Coagulation factor assay'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",1835.0,0.275471,"No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Lobo', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University Medical Center , New York , NY , USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville , Jacksonville , FL , USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine , Aurora , CO , USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD , Boca Raton , FL , USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD , Boca Raton , FL , USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD , Boca Raton , FL , USA.'}]",Climacteric : the journal of the International Menopause Society,['10.1080/13697137.2019.1640197']
890,31604674,Cognitive Outcomes of Long-term Benzodiazepine and Related Drug (BDZR) Use in People Living With Mild to Moderate Alzheimer's Disease: Results From NILVAD.,"OBJECTIVE


Benzodiazepines and related drugs (BDZRs) have been associated with an increased risk of Alzheimer's disease (AD) in later life. Despite this, it remains unclear whether ongoing BDZR use may further accelerate cognitive decline in those diagnosed with mild to moderate AD.
DESIGN


This study was embedded within NILVAD, a randomized controlled trial of nilvadipine in mild to moderate AD. Cognition was measured at baseline and 18 months using the Alzheimer Disease Assessment Scale, Cognitive Subsection (ADAS-Cog). We assessed predictors of long-term BDZR use and analyzed the effect of ongoing BDZR use on ADAS-Cog scores at 18 months. Additionally, the impact of BDZR use on adverse events, incident delirium, and falls over 18-month follow-up was assessed adjusting for relevant covariates.
SETTING AND PARTICIPANTS


448 participants with mild to moderate AD recruited from 23 academic centers in 9 European countries.
RESULTS


Overall, 14% (62/448) were prescribed an ongoing BDZR for the study duration. Increasing total number of (non-BDZR) medications was associated with a greater likelihood of BDZR prescription (odds ratio 1.16, 95% confidence interval 1.05-1.29). At 18 months, BDZR use was not associated with greater cognitive decline on the ADAS-Cog controlling for baseline ADAS-Cog scores, age, gender, study arm, and other clinical covariates (β = 1.62, -1.34 to 4.56). However, ongoing BDZR use was associated with a greater likelihood of adverse events [incidence rate ratio (IRR) 1.19, 1.05-1.34], incident delirium (IRR 2.31, 1.45-3.68), and falls (IRR 1.66, 1.02-2.65) over 18 months that persisted after robust adjustment for covariates.
CONCLUSIONS AND IMPLICATIONS


This study found no effect of ongoing BDZR use on ADAS-Cog scores in those with mild to moderate AD over 18 months. However, ongoing use of these medications was associated with an increased risk of adverse events, delirium, and falls. Thus, BDZR use should be avoided where possible and deprescribing interventions should be encouraged in older adults with AD.",2020,"At 18 months, BDZR use was not associated with greater cognitive decline on the ADAS-Cog controlling for baseline ADAS-Cog scores, age, gender, study arm, and other clinical covariates (β = 1.62, -1.34 to 4.56).","[""People Living With Mild to Moderate Alzheimer's Disease"", 'mild to moderate AD', 'older adults with AD', '448 participants with mild to moderate AD recruited from 23 academic centers in 9 European countries']","['nilvadipine', 'Long-term Benzodiazepine and Related Drug (BDZR', 'Benzodiazepines and related drugs (BDZRs']","['ADAS-Cog scores', 'Cognition', 'adverse events, incident delirium, and falls', 'incident delirium', 'risk of adverse events, delirium, and falls', 'Increasing total number of (non-BDZR) medications', 'Alzheimer Disease Assessment Scale, Cognitive Subsection (ADAS-Cog']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}]","[{'cui': 'C0132512', 'cui_str': 'nilvadipine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}]",448.0,0.19939,"At 18 months, BDZR use was not associated with greater cognitive decline on the ADAS-Cog controlling for baseline ADAS-Cog scores, age, gender, study arm, and other clinical covariates (β = 1.62, -1.34 to 4.56).","[{'ForeName': 'Adam H', 'Initials': 'AH', 'LastName': 'Dyer', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland; Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland. Electronic address: dyera@tcd.ie.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lawlor', 'Affiliation': ""Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland; Mercer's Institute for Research on Ageing, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Kennelly', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland; Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.08.006']
891,31601396,The Value of Left Ventricular Support in Patients With Reduced Left Ventricular Function Undergoing Extensive Revascularization: An Analysis From the PROTECT-II Randomized Trial.,,2019,,"['Patients With Reduced Left', 'Ventricular Function Undergoing Extensive Revascularization']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",[],[],,0.0427789,,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burke', 'Affiliation': ''}, {'ForeName': 'Harun', 'Initials': 'H', 'LastName': 'Kundi', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Almonacid', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Neill"", 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Moses', 'Affiliation': ''}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Kleiman', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': ''}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Palacios', 'Affiliation': ''}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Guzman', 'Affiliation': ''}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': ''}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': ''}, {'ForeName': 'Duane S', 'Initials': 'DS', 'LastName': 'Pinto', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.07.050']
892,31020797,Intra-aortic balloon pump counterpulsation in extensive myocardial infarction with persistent ischemia: The SEMPER FI pilot study.,"OBJECTIVES


This study aimed to prospectively investigate intra-aortic balloon pump counterpulsation (IABP) support in large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI).
BACKGROUND


Use of IABP is suggested to be effective by increasing diastolic aortic pressure, thereby improving coronary blood flow. This can only be expected with exhausted coronary autoregulation, typical in acute myocardial infarction complicated by persistent ischemia. In this situation, augmented diastolic pressure is expected to increase myocardial oxygenation.
METHODS


One hundred patients with large STEMI complicated by persistent ischemia after primary PCI were randomized to treatment with or without IABP therapy on top of standard care. IABP support was initiated following primary PCI, immediately after inclusion. Primary end point was all-cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months.
RESULTS


Mean age was 63 ± 10 years, 76% were male. Mean systolic and diastolic blood pressure were 120 ± 25 mmHg and 73 ± 17 mmHg. Mean heart rate was 75 ± 18 mmHg. Before PCI, mean summed ST-deviation was 21 ± 8 mm with only minimal ST-resolution after PCI. One patient in the IABP group reached the primary end point versus four patients in the control group (2% vs. 8%; p = 0.16). After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01).
CONCLUSIONS


In this pilot study, in patients with large STEMI and persistent ischemia after primary PCI, use of IABP showed a nonsignificant decrease in mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure at 6 months, and resulted in more rapid ST-resolution.",2020,"After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01).
","['extensive myocardial infarction with persistent ischemia', 'Mean age was 63\u2009±\u200910 years, 76% were male', 'One hundred patients with large STEMI complicated by persistent ischemia after primary PCI', 'large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI']","['IABP', 'Intra-aortic balloon pump counterpulsation', 'IABP therapy', 'aortic balloon pump counterpulsation (IABP']","['resolution of ST-deviation', 'diastolic aortic pressure', 'coronary blood flow', 'myocardial oxygenation', 'Mean systolic and diastolic blood pressure', 'cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months', 'diastolic pressure', 'Mean heart rate', 'mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure']","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump, device (physical object)'}, {'cui': 'C0010216', 'cui_str': 'Counterpulsation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump, device (physical object)'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",100.0,0.0286795,"After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01).
","[{'ForeName': 'Lokien X', 'Initials': 'LX', 'LastName': 'van Nunen', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Wijnbergen', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Guus R G', 'Initials': 'GRG', 'LastName': 'Brueren', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Pim A L', 'Initials': 'PAL', 'LastName': 'Tonino', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Wilbert A', 'Initials': 'WA', 'LastName': 'Aarnoudse', 'Affiliation': 'Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Nico H J', 'Initials': 'NHJ', 'LastName': 'Pijls', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28289']
893,28933613,A randomized controlled feasibility trial exploring partnered ballroom dancing for people with Parkinson's disease.,"OBJECTIVE


To determine the feasibility of a Dance Centre delivering a programme of mixed dances to people with Parkinson's and identify suitable outcomes for a future definitive trial.
DESIGN


A two-group randomized controlled feasibility trial.
METHODS


People with Parkinson's were randomized to a control or experimental group (ratio 15:35), alongside usual care. In addition, participants in the experimental group danced with a partner for one hour, twice-a-week for 10 weeks; professional dance teachers led the classes and field-notes were kept. Control-group participants were given dance class vouchers at the end of the study. Blinded assessments of balance, mobility and function were completed in the home. Qualitative interviews were conducted with a subsample to explore the acceptability of dance.
RESULTS


A total of 51 people with Parkinson's (25 male) with Hoehn and Yahr scores of 1-3 and mean age of 71 years (range 49-85 years), were recruited to the study. Dance partners were of similar age (mean 68, range 56-91 years). Feasibility findings focused on recruitment (target achieved); retention (five people dropped out of dancing); outcome measures (three measures were considered feasible, changes were recommended). Proposed sample size for a Phase III trial, based on the 6-minute walk test at six months was 220. Participants described dance as extremely enjoyable and the instructors were skilled in instilling confidence and motivation. The main organizational challenges for a future trial were transport and identifying suitable dance partners.
CONCLUSION


We have demonstrated the feasibility of conducting the study through a Dance Centre and recommend a Phase III trial.",2017,"A total of 51 people with Parkinson's (25 male) with Hoehn and Yahr scores of 1-3 and mean age of 71 years (range 49-85 years), were recruited to the study.","[""People with Parkinson's"", ""people with Parkinson's"", 'Dance partners were of similar age (mean 68, range 56-91 years', ""51 people with Parkinson's (25 male) with Hoehn and Yahr scores of 1-3 and mean age of 71 years (range 49-85 years"", ""people with Parkinson's disease""]",[],[],"[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]",[],[],51.0,0.112035,"A total of 51 people with Parkinson's (25 male) with Hoehn and Yahr scores of 1-3 and mean age of 71 years (range 49-85 years), were recruited to the study.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kunkel', 'Affiliation': '1 Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fitton', 'Affiliation': '1 Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': '1 Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Pickering', 'Affiliation': '2 Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Roberts', 'Affiliation': '2 Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wiles', 'Affiliation': '3 Faculty of Social Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hulbert', 'Affiliation': '1 Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Robison', 'Affiliation': '1 Faculty of Health Science, University of Southampton, Southampton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ashburn', 'Affiliation': '1 Faculty of Health Science, University of Southampton, Southampton, UK.'}]",Clinical rehabilitation,['10.1177/0269215517694930']
894,30020415,"Screening, Recruitment, and Baseline Characteristics for the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study.","Background


We describe the recruitment of participants for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large pragmatic cluster randomized trial that is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Eligible persons were 70 years or older, community-living, and at increased risk for serious fall injuries. The modified goal was to recruit 5,322 participants over 20 months from 86 primary care practices within 10 diverse health care systems across the United States.
Methods


The at-risk population was identified using two distinct but complementary screening strategies that included three questions administered centrally via the mail (nine sites) or in the clinic (one site), while recruitment was completed centrally by staff at Yale.
Results


For central screening, 226,603 letters mailed to 135,118 patients yielded 28,719 positive screens (12.7% of those mailed and 46.5% of the 61,729 returned). In the clinic, 22,537 screens were completed, leading to 5,732 positive screens (25.4%). Of the 34,451 patients who screened positive for high risk of serious fall injuries, 31,872 were sent a recruitment packet and, of these, 5,451 (17.1%) were enrolled over 20 months (mean age: 80 years; 62% female). The participation rate was 34.0% among eligible patients. The enrollment yields were 3.6% (vs 5% projected) for each patient screened centrally, despite multiple screens, and 10.5% (vs 33.9% projected) for each positive clinic screen.
Conclusions


Despite lower-than-expected yields, the STRIDE Study exceeded its modified recruitment goal. If the STRIDE intervention is found to be effective, the two distinct strategies for identifying a high-risk population of older persons could be implemented by most health care systems.",2018,"The enrollment yields were 3.6% (vs 5% projected) for each patient screened centrally, despite multiple screens, and 10.5% (vs 33.9% projected) for each positive clinic screen.
","['Eligible persons were 70 years or older, community-living, and at increased risk for serious fall injuries', '34,451 patients who screened positive for high risk of serious fall injuries, 31,872 were sent a recruitment packet and, of these, 5,451 (17.1%) were enrolled over 20 months (mean age: 80 years; 62% female', 'participants for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE', '5,322 participants over 20 months from 86 primary care practices within 10 diverse health care systems across the United States']",['multifactorial intervention'],"['enrollment yields', 'participation rate']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1301836', 'cui_str': 'Falling injury (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1641805', 'cui_str': 'Packet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]",[],[],22537.0,0.0356313,"The enrollment yields were 3.6% (vs 5% projected) for each patient screened centrally, despite multiple screens, and 10.5% (vs 33.9% projected) for each positive clinic screen.
","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McGloin', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Charpentier', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Katy L', 'Initials': 'KL', 'LastName': 'Araujo', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Skokos', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Yale School of Medicine, Yale Center for Medical Informatics, New Haven, Connecticut.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shelton', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Luanne M', 'Initials': 'LM', 'LastName': 'Bianco', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Carnie', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Covinsky', 'Affiliation': 'Division of Geriatrics, UCSF, California.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dykes', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Esserman', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Jerry H', 'Initials': 'JH', 'LastName': 'Gurwitz', 'Affiliation': 'Meyers Primary Care Institute, Worcester, Massachusetts.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanson', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Linda V', 'Initials': 'LV', 'LastName': 'Nyquist', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Reuben', 'Affiliation': 'Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/gly076']
895,29562151,A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis.,"BACKGROUND


High-flow oxygen therapy through a nasal cannula has been increasingly used in infants with bronchiolitis, despite limited high-quality evidence of its efficacy. The efficacy of high-flow oxygen therapy through a nasal cannula in settings other than intensive care units (ICUs) is unclear.
METHODS


In this multicenter, randomized, controlled trial, we assigned infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy to receive either high-flow oxygen therapy (high-flow group) or standard oxygen therapy (standard-therapy group). Infants in the standard-therapy group could receive rescue high-flow oxygen therapy if their condition met criteria for treatment failure. The primary outcome was escalation of care due to treatment failure (defined as meeting ≥3 of 4 clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool). Secondary outcomes included duration of hospital stay, duration of oxygen therapy, and rates of transfer to a tertiary hospital, ICU admission, intubation, and adverse events.
RESULTS


The analyses included 1472 patients. The percentage of infants receiving escalation of care was 12% (87 of 739 infants) in the high-flow group, as compared with 23% (167 of 733) in the standard-therapy group (risk difference, -11 percentage points; 95% confidence interval, -15 to -7; P<0.001). No significant differences were observed in the duration of hospital stay or the duration of oxygen therapy. In each group, one case of pneumothorax (<1% of infants) occurred. Among the 167 infants in the standard-therapy group who had treatment failure, 102 (61%) had a response to high-flow rescue therapy.
CONCLUSIONS


Among infants with bronchiolitis who were treated outside an ICU, those who received high-flow oxygen therapy had significantly lower rates of escalation of care due to treatment failure than those in the group that received standard oxygen therapy. (Funded by the National Health and Medical Research Council and others; Australian and New Zealand Clinical Trials Registry number, ACTRN12613000388718 .).",2018,No significant differences were observed in the duration of hospital stay or the duration of oxygen therapy.,"['infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy to receive either', 'Infants with Bronchiolitis', 'standard-therapy group', 'infants with bronchiolitis', '1472 patients', '167 infants in the standard-therapy group who had treatment failure, 102 (61%) had a response to high-flow rescue therapy']","['High-Flow Oxygen Therapy', 'high-flow oxygen therapy (high-flow group) or standard oxygen therapy', 'high-flow oxygen therapy', 'rescue high-flow oxygen therapy', 'standard oxygen therapy']","['percentage of infants receiving escalation of care', 'duration of hospital stay, duration of oxygen therapy, and rates of transfer to a tertiary hospital, ICU admission, intubation, and adverse events', 'escalation of care due to treatment failure (defined as meeting ≥3 of 4 clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool', 'duration of hospital stay or the duration of oxygen therapy', 'rates of escalation of care due to treatment failure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0162643'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",,0.275086,No significant differences were observed in the duration of hospital stay or the duration of oxygen therapy.,"[{'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Furyk', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': ""From the Pediatric Critical Care Research Group, Centre for Children's Health Research, Lady Cilento Children's Hospital, and Mater Research Institute (D.F., L.J.S., A.S.), the Schools of Medicine (D.F., L.J.S., J.F.F., A.S.) and Public Health (M.J.), University of Queensland, and the Critical Care Research Group, Adult Intensive Care Service, Prince Charles Hospital (D.F., J.F.F.), Brisbane, the Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, VIC (D.F., F.E.B., E.O., S.C., J.N., J.F., S.R.D., A.S.), Royal Children's Hospital, the Emergency Department, Murdoch Children's Research Institute, and the Department of Paediatrics, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC (F.E.B., E.O.), the Department of Medicine, School of Clinical Sciences, Monash University, and the Paediatric Emergency Department, Monash Medical Centre, Monash Health, Clayton, VIC (S.C.), and the College of Medicine and Dentistry, James Cook University, and the Emergency Department, Townsville Hospital, Townsville, QLD (J.F.) - all in Australia; the Department of Pediatrics, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland (L.J.S.); KidzFirst Middlemore Hospital and the University of Auckland (J.N.) and the Children's Emergency Department, Starship Children's Hospital, and Liggins Institute, University of Auckland (S.R.D.), Auckland, New Zealand; and Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (J.A.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa1714855']
896,31624391,[Study on the use of CT three-dimensional reconstruction technique for guiding tracheal intubation with rigid fiber bronchoscope in difficult airway].,"OBJECTIVE


To evaluate the significance of CT three-dimensional reconstruction technique for guiding tracheal intubation with rigid fiber bronchoscope in difficult airway.
METHODS


In this study, 44 patients undergoing selective operation of ASA (American Society of Anesthesiologists physical status) I to II, neck stiffness, neck trauma needed braked, or severe cervical spondylosis were selected. The patients were randomly divided into two groups: 24 cases in the experimental group (group E) and 20 cases in the control group (group C). The stylets of the rigid fiber bronchoscopes were shaped according to the CT three-dimensional reconstruction images and parameters obtained before surgery. The rigid fiber bronchoscopes shaped according to the CT three-dimensional reconstruction images were used in group E, while the rigid fiber bronchoscopes with the original angles were used in group C. Tracheal intubation operations were all performed by an anesthesiologist who had more than 10 years' clinical experience and mastered in rigid endoscopic intubation techniques. The first attempt success rate and the total success rate of tracheal intubation, intubation time, blood pressure, heart rate and pulse oxygen saturation at different time points including pre-induction, immediately after intubation, 1-5 minutes after intubation, and intubation related complications within 24 hours were recorded.
RESULTS


The total success rate of intubation in the two groups were both 100%. The first attempt success rate of intubation was 96% in group E, and 70% in group C. The first attempt success rate of group E was higher than that of group C. The intubation time of group E was (20.7± 10.6) s, and (21.5 ± 17.6) s of group C. Group E was shorter than that of group C, but there was no significant difference (P > 0.05). RPP equaled the product of heart rate and systolic pressure, which represented the stress reaction of intubation on hemodynamics, was lower in group C at T0, T1, T2, T4 and T5 separately than that in group E, but there was no significant difference (P>0.05). There was no significant difference in tracheal intubation related complications between the two groups (P>0.05).
CONCLUSION


CT three-dimensional reconstruction technique has certain guiding significance in difficult tracheal intubation with rigid fiber bronchoscope in patients with fixed cervical spine.",2019,"There was no significant difference in tracheal intubation related complications between the two groups (P>0.05).
","['44 patients undergoing selective operation of ASA (American Society of Anesthesiologists physical status', 'patients with fixed cervical spine']","['rigid fiber bronchoscope', 'CT three-dimensional reconstruction technique', 'rigid endoscopic intubation techniques']","['intubation time', 'total success rate of intubation', 'heart rate and systolic pressure', 'tracheal intubation related complications', 'total success rate of tracheal intubation, intubation time, blood pressure, heart rate and pulse oxygen saturation at different time points including pre-induction, immediately after intubation, 1-5 minutes after intubation, and intubation related complications', 'success rate of intubation', 'stress reaction of intubation on hemodynamics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}]","[{'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscopes'}, {'cui': 'C0729707', 'cui_str': 'Computerized tomography, 3 dimensional reconstruction (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1562228', 'cui_str': 'Intubation technique'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",44.0,0.0190362,"There was no significant difference in tracheal intubation related complications between the two groups (P>0.05).
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology, China\ue011Japan Friendship Hopital, Beijing 100029, China.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Qian', 'Affiliation': 'Department of Anesthesiology, China\ue011Japan Friendship Hopital, Beijing 100029, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'Department of Medical Image, China\ue011Japan Friendship Hopital, Beijing 100029, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Image, China\ue011Japan Friendship Hopital, Beijing 100029, China.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China\ue011Japan Friendship Hopital, Beijing 100029, China.'}, {'ForeName': 'Y Q', 'Initials': 'YQ', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, China\ue011Japan Friendship Hopital, Beijing 100029, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
897,31617048,Adherence to behavioral recommendations for weight loss and associated psychosocial factors among African American adults.,"PURPOSE


To identify patterns of behavioral adherence among 388 African Americans who participated in the Weight Loss Maintenance trial and examine associated psychosocial factors.
METHODS


Using repeated measures latent class analysis, we modeled patterns of adherence to recommendations regarding fruit and vegetable, total fat, and saturated fat intake and physical activity at baseline, 6, and 18 months. Latent classes were compared on the SF-36 (mental health composite and vitality subscale), Perceived Stress Scale, and PHQ-8 at each time point.
RESULTS


Three distinct latent classes emerged: Nutrition Adherers (n = 96); Physical Activity Adherers (n = 61); and Non-Adherers (n = 231). All groups showed initial improvement in psychosocial measures followed by relapse. Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months.
CONCLUSION


Psychological well-being should be addressed with African Americans in weight loss treatment to enhance behavior change and improve weight loss outcomes.",2020,"Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months.
","['388 African Americans who participated in the Weight Loss Maintenance trial and examine associated psychosocial factors', 'African American adults']",[],"['Nutrition Adherers', 'mean mental health and vitality scores and higher depression scores', 'weight loss outcomes', 'SF-36 (mental health composite and vitality subscale), Perceived Stress Scale, and PHQ-8 at each time point', 'Physical Activity Adherers', 'adherence to recommendations regarding fruit and vegetable, total fat, and saturated fat intake and physical activity', 'psychosocial measures']","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",388.0,0.0180087,"Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months.
","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Fitzpatrick', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA. Stephanie.L.Fitzpatrick@kpchr.org.'}, {'ForeName': 'Neon', 'Initials': 'N', 'LastName': 'Brooks', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Bray', 'Affiliation': 'The Methodology Center, Penn State University, State College, PA, USA.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Stevens', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00108-2']
898,31628486,An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs.,"OBJECTIVES


The objective of this trial was to compare effectiveness of certolizumab pegol added to conventional synthetic DMARDs (csDMARDs) in RA patients, followed by continuing vs discontinuing background csDMARDs after treatment response.
METHODS


Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible. At 3 or 6 months, patients who achieved a change (Δ) in DAS28 of ⩾1.2 were randomized to continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO) (unblinded). The primary outcome was non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity at 18 months (non-inferiority margin: 15 percentile units).
RESULTS


A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45). No significant differences were observed between groups in baseline age, gender, race, RF status or prior biologics (16% vs 11%). Although the rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement at 18 months was clinically comparable between the two groups (72% vs 69%), non-inferiority assumptions were not met [absolute risk difference (upper limit of 90% CI): 2.6% (19.1%)]. Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28 ⩾ 1.2, and 41% each remission.
CONCLUSION


Among RA patients achieving a therapeutic response on combination therapy with certolizumab pegol and csDMARDs, withdrawing csDMARDs was not non-inferior to maintaining csDMARDs but improvements were sustained in both groups at 18 months.",2020,"Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28","['RA patients', 'Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible', 'A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45']","['certolizumab pegol added to conventional synthetic DMARDs (csDMARDs', 'certolizumab pegol combined with DMARDs', 'ΔDAS28', 'continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO']","['RF status or prior biologics', 'rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement', 'non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity', 'DAS28 low disease activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",88.0,0.172243,"Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'Department of Medicine, University of Western Ontario, ON.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Rampakakis', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Vaillancourt', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Department of Medicine, Laval University, Québec, QC.'}, {'ForeName': 'Juris', 'Initials': 'J', 'LastName': 'Lazovskis', 'Affiliation': 'Department of Medicine, Dalhousie University, Saint John, NB.'}, {'ForeName': 'Boulos', 'Initials': 'B', 'LastName': 'Haraoui', 'Affiliation': 'Institut de Rhumatologie de Montréal, Montréal, QC.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sampalis', 'Affiliation': 'Medical Affairs, JSS Medical Research, Montréal, QC.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez470']
899,29233085,An oncology clinical trial design with randomization adaptive to both short- and long-term responses.,"In oncology clinical trials, both short-term response and long-term survival are important. We propose an urn-based adaptive randomization design to incorporate both of these two outcomes. While short-term response can update the randomization probability quickly to benefit the trial participants, long-term survival outcome can also change the randomization to favor the treatment arm with definitive therapeutic benefit. Using generalized Friedman's urn, we derive an explicit formula for the limiting distribution of the number of subjects assigned to each arm. With prior or hypothetical knowledge on treatment effects, this formula can be used to guide the selection of parameters for the proposed design to achieve desirable patient number ratios between different treatment arms, and thus optimize the operating characteristics of the trial design. Simulation studies show that the proposed design successfully assign more patients to the treatment arms with either better short-term tumor response or long-term survival outcome or both.",2019,Simulation studies show that the proposed design successfully assign more patients to the treatment arms with either better short-term tumor response or long-term survival outcome or both.,[],[],[],[],[],[],,0.046359,Simulation studies show that the proposed design successfully assign more patients to the treatment arms with either better short-term tumor response or long-term survival outcome or both.,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': '1 Department of Biostatistics, Indiana University School of Medicine, Indiana University Simon Cancer Center, Indianapolis, IN, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': '2 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuelin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': '2 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Statistical methods in medical research,['10.1177/0962280217744816']
900,25445551,The IMPORT HIGH image-guided radiotherapy study: a model for assessing image-guided radiotherapy.,,2015,,[],[],[],[],[],[],,0.0169284,,"[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Donovan', 'Affiliation': 'Joint Department of Physics at The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Harris', 'Affiliation': 'Joint Department of Physics at The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Mukesh', 'Affiliation': 'Oncology Centre, Colchester Hospital University NHS Trust, Colchester, UK.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Haviland', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Titley', 'Affiliation': 'ICR-CTSU, Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'ICR-CTSU, Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Coles', 'Affiliation': 'Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Evans', 'Affiliation': 'Centre for Vision Speech and Signal Processing, Faculty of Engineering and Physical Sciences, University of Surrey, Guildford, UK. Electronic address: p.evans@surrey.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2014.09.012']
901,31521645,3-Year Outcomes of the DKCRUSH-V Trial Comparing DK Crush With Provisional Stenting for Left Main Bifurcation Lesions.,"OBJECTIVES


The present study aimed to investigate the difference in target lesion failure (TLF) at 3 years after double kissing (DK) crush stenting versus provisional stenting (PS) for unprotected left main distal bifurcation (UPLMb) lesions.
BACKGROUND


The multicenter and randomized DKCRUSH-V (Double Kissing Crush versus Provisional Stenting for Left Main Distal Bifurcation Lesions: The DKCRUSH-V Randomized Trial) study showed fewer 1-year TLF after DK crush for UPLMb lesions compared with PS. The study reports the 3-year clinical outcome of the DKCRUSH-V study.
METHODS


A total of 482 patients with UPLMb lesions who were randomly assigned to either the DK crush group (DK group) or PS group in the DKCRUSH-V study were followed for 3 years. The primary endpoint was the occurrence of a TLF at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score.
RESULTS


At 3 years, TLF occurred in 41 (16.9%) patients in the PS group and in 20 (8.3%) patients in the DK group (p = 0.005), mainly driven by increased target vessel myocardial infarction (5.8% vs. 1.7%; p = 0.017) and target lesion revascularization (10.3% vs. 5.0%; p = 0.029). Definite or probable ST rate at 3 years was 4.1% in the PS group and 0.4% in the DK group (p = 0.006). Notably, DK crush was associated with a significant reduction in both primary and secondary endpoints for patients with complex lesions or at high risk.
CONCLUSIONS


Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up. Further randomized study is warranted to confirm the benefits of DK crush stenting for complex UPLMb lesions. (Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial; ChiCTR-TRC-11001213).",2019,Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up.,"[""Patients were classified by lesion's complexity and NERS (New Risk Stratification) II or SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score"", '482 patients with UPLMb lesions', 'Left Main Distal Bifurcation Lesions']","['DKCRUSH-V (Double Kissing Crush versus Provisional Stenting', 'double kissing (DK) crush stenting versus provisional stenting (PS', 'Provisional Stenting', 'Double Kissing and Double Crush versus Provisional T Stenting Technique', 'DK crush stenting', 'DK crush group (DK group) or PS', 'Provisional stenting']","['target vessel myocardial infarction', 'Definite or probable ST rate', 'rates of TLF and ST', 'Stent thrombosis (ST', 'TLF', 'occurrence of a TLF', 'target lesion failure (TLF', 'target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",482.0,0.181288,Provisional stenting for UPLMb lesions was associated with significantly increased rates of TLF and ST over 3 years of follow-up.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Shenyang Northen Hospital, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lianglong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, United Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Qiu', 'Affiliation': 'Division of Cardiology, Zhengzhou University First Hospital, Zhengzhou, China.'}, {'ForeName': 'Teguh', 'Initials': 'T', 'LastName': 'Santoso', 'Affiliation': 'Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarta, Indonesia.'}, {'ForeName': 'Chootopol', 'Initials': 'C', 'LastName': 'Paiboon', 'Affiliation': 'Division of Cardiology, Bangkok General Hospital, Bangkok, Thailand.'}, {'ForeName': 'Tak W', 'Initials': 'TW', 'LastName': 'Kwan', 'Affiliation': 'Division of Cardiology, Beth Israel Hospital, New York, New York.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Sheiban', 'Affiliation': 'Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China; Key Laboratory of Cardiovascular and Cerebrovascular Medicine, School of Pharmacy, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.056']
902,29092879,Eggs early in complementary feeding increase choline pathway biomarkers and DHA: a randomized controlled trial in Ecuador.,"Background:  Choline status has been associated with stunting among young children. Findings from this study showed that an egg intervention improved linear growth by a length-for-age  z  score of 0.63. Objective:  We aimed to test the efficacy of eggs introduced early in complementary feeding on plasma concentrations of biomarkers in choline pathways, vitamins B-12 and A, and essential fatty acids. Design:  A randomized controlled trial, the Lulun (""egg"" in Kichwa) Project, was conducted in a rural indigenous population of Ecuador. Infants aged 6-9 mo were randomly assigned to treatment (1 egg/d for 6 mo;  n  = 80) and control (no intervention;  n  = 83) groups. Socioeconomic data, anthropometric measures, and blood samples were collected at baseline and endline. Household visits were made weekly for morbidity surveillance. We tested vitamin B-12 plasma concentrations by using chemiluminescent competitive immunoassay and plasma concentrations of choline, betaine, dimethylglycine, retinol, essential fatty acids, methionine, dimethylamine (DMA), trimethylamine, and trimethylamine- N -oxide (TMAO) with the use of liquid chromatography-tandem mass spectrometry. Results:  Socioeconomic factors and biomarker concentrations were comparable at baseline. Of infants, 11.4% were vitamin B-12 deficient and 31.7% marginally deficient at baseline. In adjusted generalized linear regression modeling, the egg intervention increased plasma concentrations compared with control by the following effect sizes: choline, 0.35 (95% CI: 0.12, 0.57); betaine, 0.29 (95% CI: 0.01, 0.58); methionine, 0.31 (95% CI: 0.03, 0.60); docosahexaenoic acid, 0.43 (95% CI: 0.13, 0.73); DMA, 0.37 (95% CI: 0.37, 0.69); and TMAO, 0.33 (95% CI: 0.08, 0.58). No significant group differences were found for vitamin B-12, retinol, linoleic acid (LA), α-linolenic acid (ALA), or ratios of betaine to choline and LA to ALA. Conclusion:  The findings supported our hypothesis that early introduction of eggs significantly improved choline and other markers in its methyl group metabolism pathway. This trial was registered at clinicaltrials.gov as NCT02446873.",2017,"No significant group differences were found for vitamin B-12, retinol, linoleic acid (LA), α-linolenic acid (ALA), or ratios of betaine to choline and LA to ALA.","['rural indigenous population of Ecuador', 'young children', 'Infants aged 6-9 mo']",[],"['vitamin B-12, retinol, linoleic acid (LA), α-linolenic acid (ALA), or ratios of betaine to choline and LA to ALA', 'Socioeconomic data, anthropometric measures, and blood samples', 'plasma concentrations of choline, betaine, dimethylglycine, retinol, essential fatty acids, methionine, dimethylamine (DMA), trimethylamine, and trimethylamine- N -oxide (TMAO', 'morbidity surveillance', 'plasma concentrations', 'Socioeconomic factors and biomarker concentrations', 'linear growth']","[{'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0023750', 'cui_str': 'Linoleic Acids'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0058265', 'cui_str': 'glycine, N,N-dimethyl-'}, {'cui': 'C0015686', 'cui_str': 'Fatty Acids, Essential'}, {'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0058246', 'cui_str': 'dimethylamine'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0037464', 'cui_str': 'Socioeconomic Factors'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.462427,"No significant group differences were found for vitamin B-12, retinol, linoleic acid (LA), α-linolenic acid (ALA), or ratios of betaine to choline and LA to ALA.","[{'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Institute for Public Health, and liannotti@wustl.edu.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'School of Public Health, University of Maryland, College Park, MD.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Waters', 'Affiliation': 'Institute for Research in Health and Nutrition, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'Carlos Andres', 'Initials': 'CA', 'LastName': 'Gallegos Riofrío', 'Affiliation': 'Brown School, Institute for Public Health, and.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Malo', 'Affiliation': 'Institute for Research in Health and Nutrition, Universidad San Francisco de Quito, Quito, Ecuador.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reinhart', 'Affiliation': 'The Mathile Institute for the Advancement of Human Nutrition, Dayton, OH.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Palacios', 'Affiliation': 'The Mathile Institute for the Advancement of Human Nutrition, Dayton, OH.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Karp', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chapnick', 'Affiliation': 'Brown School, Institute for Public Health, and.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Brown School, Institute for Public Health, and.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Aguirre', 'Affiliation': 'NETLAB Laboratorios Especializados, Quito, Ecuador; and.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Narvaez', 'Affiliation': 'NETLAB Laboratorios Especializados, Quito, Ecuador; and.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'López', 'Affiliation': 'NETLAB Laboratorios Especializados, Quito, Ecuador; and.'}, {'ForeName': 'Rohini', 'Initials': 'R', 'LastName': 'Sidhu', 'Affiliation': 'Diabetic Cardiovascular Disease Center, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kell', 'Affiliation': 'Diabetic Cardiovascular Disease Center, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Xuntian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Diabetic Cardiovascular Disease Center, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Hideji', 'Initials': 'H', 'LastName': 'Fujiwara', 'Affiliation': 'Diabetic Cardiovascular Disease Center, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ory', 'Affiliation': 'Diabetic Cardiovascular Disease Center, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA.'}]",The American journal of clinical nutrition,['10.3945/ajcn.117.160515']
903,28810442,Evaluation of a web-based cognitive behavioral smoking cessation treatment for overweight/obese smokers.,"This pilot study tested the efficacy of an Internet-administered smoking cessation treatment for overweight/obese smokers. Participants were 54 community volunteers with overweight/obesity who were regular smokers. Treatment consisted of 12 weeks of nicotine replacement therapy and randomization to Internet-administered cognitive behavioral treatment or health education. In-person assessments of key outcomes occurred at baseline, post-treatment, and at 24-week follow-up. Cessation rates did not differ across the two treatments (25.9% vs 18.5%). Participants receiving cognitive behavioral treatment gained less weight when abstinent than those receiving the standard treatment. Larger studies are needed to replicate these findings.",2019,Cessation rates did not differ across the two treatments (25.9% vs 18.5%).,"['Participants were 54 community volunteers with overweight/obesity who were regular smokers', 'overweight/obese smokers']","['web-based cognitive behavioral smoking cessation treatment', 'Internet-administered smoking cessation treatment', 'cognitive behavioral treatment', 'nicotine replacement therapy and randomization to Internet-administered cognitive behavioral treatment or health education']",['Cessation rates'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0018701'}]",[],54.0,0.0133806,Cessation rates did not differ across the two treatments (25.9% vs 18.5%).,"[{'ForeName': 'Marney A', 'Initials': 'MA', 'LastName': 'White', 'Affiliation': 'Department of Social and Behavioral Sciences, Yale School of Public Health, USA.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ivezaj', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Department of Psychiatry, Yale University School of Medicine, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Program for Obesity, Weight, and Eating Research, Department of Psychiatry, Yale University School of Medicine, USA.'}]",Journal of health psychology,['10.1177/1359105317701560']
904,31621832,Chemoprophylaxis Vaccination: Phase I Study to Explore Stage-specific Immunity to Plasmodium falciparum in US Adults.,"BACKGROUND


Chemoprophylaxis vaccination with sporozoites (CVac) with chloroquine induces protection against a homologous Plasmodium falciparum sporozoite (PfSPZ) challenge, but whether blood-stage parasite exposure is required for protection remains unclear. Chloroquine suppresses and clears blood-stage parasitemia, while other antimalarial drugs, such as primaquine, act against liver-stage parasites. Here, we evaluated CVac regimens using primaquine and/or chloroquine as the partner drug to discern whether blood-stage parasite exposure impacts protection against homologous controlled human malaria infection.
METHODS


In a Phase I, randomized, partial double-blind, placebo-controlled study of 36 malaria-naive adults, all CVac subjects received chloroquine prophylaxis and bites from 12-15 P. falciparum-infected mosquitoes (CVac-chloroquine arm) at 3 monthly iterations, and some received postexposure primaquine (CVac-primaquine/chloroquine arm). Drug control subjects received primaquine, chloroquine, and uninfected mosquito bites. After a chloroquine washout, subjects, including treatment-naive infectivity controls, underwent homologous, PfSPZ controlled human malaria infection and were monitored for parasitemia for 21 days.
RESULTS


No serious adverse events occurred. During CVac, all but 1 subject in the study remained blood-smear negative, while only 1 subject (primaquine/chloroquine arm) remained polymerase chain reaction-negative. Upon challenge, compared to infectivity controls, 3/3 chloroquine arm subjects displayed delayed patent parasitemia (P = .01) but not sterile protection, while 3/11 primaquine/chloroquine subjects remained blood-smear negative.
CONCLUSIONS


CVac-primaquine/chloroquine is safe and induces sterile immunity to P. falciparum in some recipients, but a single 45 mg dose of primaquine postexposure does not completely prevent blood-stage parasitemia. Unlike previous studies, CVac-chloroquine did not produce sterile immunity.
CLINICAL TRIALS REGISTRATION


NCT01500980.",2020,No serious adverse events occurred.,"['36 malaria-naïve adults, all CVac subjects received', 'U.S. adults']","['primaquine, chloroquine, and uninfected mosquito bites', 'CVac-primaquine/chloroquine', 'Chemoprophylaxis vaccination', 'chloroquine or primaquine', 'placebo', 'primaquine/chloroquine', 'chloroquine prophylaxis and bites from 12-15 P. falciparum-infected mosquitoes (CVac-chloroquine arm) at 3 monthly iterations, and some received post-exposure primaquine (CVac-primaquine/chloroquine arm', 'primaquine', 'Chloroquine', 'CVac-chloroquine', 'chloroquine']","['blood smear-negative', 'blood-stage parasitemia', 'blood smear negative', 'delayed patent parasitemia']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0417744', 'cui_str': 'Mosquito bite (disorder)'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0005768'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0030650', 'cui_str': 'Patent'}]",,0.0560313,No serious adverse events occurred.,"[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Healy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Murphy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Jen C C', 'Initials': 'JCC', 'LastName': 'Hume', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shelton', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kuntz', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Van Voorhis', 'Affiliation': 'Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Metch', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Ruobing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Silver-Brace', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fishbaugher', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Olivia C', 'Initials': 'OC', 'LastName': 'Finney', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Chaturvedi', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Marcsisin', 'Affiliation': 'Military Malaria Research Program, Division of Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Charlotte V', 'Initials': 'CV', 'LastName': 'Hobbs', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Warner-Lubin', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Talley', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wong-Madden', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Stuart', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Department of Laboratory Medicine and Microbiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Kappe', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Duffy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1010']
905,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
906,31593582,"Biopsying, fragmentation and autotransplantation of fresh ovarian cortical tissue in infertile women with diminished ovarian reserve.","STUDY QUESTION


Can ovarian biopsying per se and/or autotransplantation of fragmented ovarian cortical tissue activate dormant follicles and increase the number of recruitable follicles for IVF/ICSI in women with diminished ovarian reserve (DOR)?
SUMMARY ANSWER


Ovarian biopsying followed by immediate autotransplantation of fragmented cortical tissue failed to increase the number of recruitable follicles for IVF/ICSI 10 weeks after the procedure either at the graft site or in the biopsied ovary, but 12 of the 20 women subsequently had a clinical pregnancy during the 1-year follow-up.
WHAT IS KNOWN ALREADY


Infertile women with DOR constitute a group of patients with poor reproductive outcome mainly due to the low number of mature oocytes available for IVF/ICSI. Recent studies have shown that in vitro activation of residual dormant follicles by both chemical treatment and tissue fragmentation has resulted in return of menstrual cycles and pregnancies in a fraction of amenorrhoeic women with premature ovarian insufficiency.
STUDY DESIGN, SIZE, DURATION


This is a prospective clinical cohort study including 20 women with DOR treated at the fertility clinic, Rigshospitalet, Denmark, during April 2016-December 2017. Non-pregnant patients were on average followed for 280 days (range 118-408), while women who conceived were followed until delivery. Study follow-up of non-pregnant patients ended in September 2018.
PARTICIPANTS, MATERIALS, SETTING, METHODS


The study included infertile women aged 30-39 years with preserved menstrual cycles, indication for IVF/ICSI and repeated serum measurements of anti-Müllerian hormone (AMH) ≤ 5 pmol/L. Patients were randomized to have four biopsies taken from either the left or the right ovary by laparoscopy followed by fragmentation of the cortical tissue to an approximate size of 1 mm3 and autotransplanted to a peritoneal pocket. The other ovary served as a control. Patients were followed weekly for 10 weeks with recording of hormone profile, antral follicle count (AFC), ovarian volume and assessment for ectopic follicle growth. After 10 weeks, an IVF/ICSI-cycle with maximal ovarian stimulation was initiated.
MAIN RESULTS AND THE ROLE OF CHANCE


No difference in the number of mature follicles after ovarian stimulation 10 weeks after the procedure in the biopsied versus the control ovaries was observed (1.0 vs. 0.7 follicles, P = 0.35). In only three patients, growth of four follicles was detected at the graft site 24-268 days after the procedure. From one of these follicles, a metaphase II (MII) oocyte was retrieved and fertilized, but embryonic development failed. Overall AMH levels did not change significantly after the procedure (P = 0.2). The AFC increased by 0.14 (95% CI: 0.06;0.21) per week (P < 0.005), and the biopsied ovary had on average 0.6 (95% CI: 0.3;-0.88) follicles fewer than the control ovary (P = 0.01). Serum levels of androstenedione and testosterone increased significantly by 0.63 nmol/L (95% CI: 0.21;1.04) and 0.11 nmol/L (95% CI: 0.01;0.21) 1 week after the procedure, respectively, and testosterone increased consecutively over the 10 weeks by 0.0095 nmol/L (95% CI: 0.0002;0.0188) per week (P = 0.045). In 7 of the 20 patients, there was a serum AMH elevation 5 to 8 weeks after the procedure. In this group, mean AMH increased from 2.08 pmol/L (range 1.74-2.34) to 3.94 pmol/L (range 3.66-4.29) from Weeks 1-4 to Weeks 5-8. A clinical pregnancy was obtained in 12 of the 20 (60%) patients with and without medically assisted reproduction (MAR) treatments. We report a cumulated live birth rate per started IVF/ICSI cycle of 18.4%.
LIMITATIONS, REASON FOR CAUTION


Limitations of the study were the number of patients included and the lack of a non-operated control group. Moreover, 9 of the 20 women had no male partner at inclusion and were treated with donor sperm, but each of these women had an average of 6.8 (range 4-9) unsuccessful MAR treatments with donor sperm prior to inclusion.
WIDER IMPLICATIONS OF THE FINDINGS


Although 12 out of 20 patients became pregnant during the follow-up period, the current study does not indicate that biopsying, fragmenting and autotransplanting of ovarian cortical tissue increase the number of recruitable follicles for IVF/ICSI after 10 weeks. However, a proportion of the patients may have a follicular response in Weeks 5-8 after the procedure. It could therefore be relevant to perform a future study on the possible effects of biopsying per se that includes stimulation for IVF/ICSI earlier than week 10.
STUDY FUNDING/COMPETING INTEREST(S)


This study is part of the ReproUnion collaborative study, co-financed by the European Union, Interreg V ÖKS. The funders had no role in the study design, data collection and interpretation, or decision to submit the work for publication. None of the authors have a conflict of interest.
TRIAL REGISTRATION NUMBER


NCT02792569.",2019,"The AFC increased by 0.14 (95% CI: 0.06;0.21) per week (P < 0.005), and the biopsied ovary had on average 0.6 (95% CI: 0.3;-0.88) follicles fewer than the control ovary (P = 0.01).","['12 of the 20 (60%) patients with and without medically assisted reproduction (MAR) treatments', 'Infertile women with DOR', 'women with diminished ovarian reserve (DOR', '20 women with DOR treated at the fertility clinic, Rigshospitalet, Denmark, during April 2016-December 2017. Non-pregnant patients were on average followed for 280\xa0days (range 118-408), while women who conceived were followed until delivery', 'amenorrhoeic women with premature ovarian insufficiency', 'infertile women with diminished ovarian reserve', 'infertile women aged 30-39\xa0years with preserved menstrual cycles, indication for IVF/ICSI and repeated serum measurements of anti-Müllerian hormone (AMH)\u2009≤\u20095\xa0pmol/L. Patients', '20 women had no male partner at inclusion and were treated with donor sperm, but each of these women had an average of 6.8 (range 4-9) unsuccessful MAR treatments with donor sperm prior to inclusion', 'non-pregnant patients ended in September 2018']",['right ovary by laparoscopy followed by fragmentation of the cortical tissue to an approximate size of 1\xa0mm3 and autotransplanted to a peritoneal pocket'],"['clinical pregnancy', 'mean AMH', 'number of mature follicles', 'growth of four follicles', 'Overall AMH levels', 'cumulated live birth rate per started IVF/ICSI cycle', 'low number of mature oocytes available for IVF/ICSI', 'serum AMH elevation', 'Serum levels of androstenedione and testosterone', 'AFC', 'metaphase II (MII) oocyte', 'antral follicle count (AFC), ovarian volume and assessment for ectopic follicle growth', 'number of recruitable follicles for IVF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3839507', 'cui_str': 'Diminished ovarian reserve (disorder)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0439284', 'cui_str': 'fmol/mL'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0430991', 'cui_str': 'Mixed antiglobulin test for sperm (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0227873', 'cui_str': 'Structure of right ovary'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439243', 'cui_str': 'mm3'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}]",,0.159613,"The AFC increased by 0.14 (95% CI: 0.06;0.21) per week (P < 0.005), and the biopsied ovary had on average 0.6 (95% CI: 0.3;-0.88) follicles fewer than the control ovary (P = 0.01).","[{'ForeName': 'Stine Aagaard', 'Initials': 'SA', 'LastName': 'Lunding', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Susanne Elisabeth', 'Initials': 'SE', 'LastName': 'Pors', 'Affiliation': 'Laboratory of Reproductive Biology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Stine Gry', 'Initials': 'SG', 'LastName': 'Kristensen', 'Affiliation': 'Laboratory of Reproductive Biology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Selma Kloeve', 'Initials': 'SK', 'LastName': 'Landersoe', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Janni Vikkelsø', 'Initials': 'JV', 'LastName': 'Jeppesen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Esben Meulengracht', 'Initials': 'EM', 'LastName': 'Flachs', 'Affiliation': 'Department of Occupational and Environmental Medicine, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kirsten Tryde', 'Initials': 'KT', 'LastName': 'Macklon', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anette Tønnes', 'Initials': 'AT', 'LastName': 'Pedersen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus Yding', 'Initials': 'CY', 'LastName': 'Andersen', 'Affiliation': 'Laboratory of Reproductive Biology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anders Nyboe', 'Initials': 'AN', 'LastName': 'Andersen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez152']
907,28810466,Mediation of an efficacious HIV risk reduction intervention for adolescents: A cluster-randomised controlled trial.,"The 'Cuidate' programme for adolescents in Spain has proven to be effective for promoting healthy sexuality ( N  = 626), but the mechanisms underlying its effects are unknown. This study aimed to identify mediators of the intervention's effects compared to a control group. Participants were students from five areas of Spain, who completed baseline, immediate-posttest, 12-month and 24-month follow-up assessments. Mediation analyses revealed that 'Cuidate' positively affected consistent condom use indirectly through knowledge in serial with the intention to use condoms. The findings underscore the importance of targeting knowledge on HIV and sexually transmitted infections to promote condom use intention and consistent condom use.",2019,Mediation analyses revealed that 'Cuidate' positively affected consistent condom use indirectly through knowledge in serial with the intention to use condoms.,"['Participants were students from five areas of Spain, who completed baseline, immediate-posttest, 12-month and 24-month follow-up assessments', 'adolescents']",['efficacious HIV risk reduction intervention'],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",[],,0.0631008,Mediation analyses revealed that 'Cuidate' positively affected consistent condom use indirectly through knowledge in serial with the intention to use condoms.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Morales', 'Affiliation': 'Miguel Hernández University of Elche, Spain.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Espada', 'Affiliation': 'Miguel Hernández University of Elche, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Orgilés', 'Affiliation': 'Miguel Hernández University of Elche, Spain.'}]",Journal of health psychology,['10.1177/1359105317707256']
908,31617562,Effect of Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician for Improving Health-Related Quality of Life in Home-Dwelling Older Patients Receiving Polypharmacy: A Cluster Randomized Clinical Trial.,"Importance


Polypharmacy and inappropriate drug regimens are major health concerns among older adults. Various interventions focused on medication optimization strategies have been carried out, but the effect on patient-relevant outcomes remains uncertain.
Objective


To investigate the effect of clinical geriatric assessments and collaborative medication reviews by geriatrician and family physician (FP) on health-related quality of life and other patient-relevant outcomes in home-dwelling older patients receiving polypharmacy.
Design, Setting, and Participants


Cluster randomized, single-blind, clinical trial. Norwegian FPs were recruited from March 17, 2015, to March 16, 2017, to participate in the trial with their eligible patients. Participants were home-dwelling patients 70 years or older, using at least 7 medications regularly, and having their medications administered by the home nursing service. Patients in the control group received usual care. Randomization occurred at the FP level. A modified intent-to-treat analysis was used.
Intervention


The intervention consisted of 3 main parts: (1) clinical geriatric assessment of the patients combined with a thorough review of their medications; (2) a meeting between the geriatrician and the FP; and (3) clinical follow-up.
Main Outcomes and Measures


The primary outcome was health-related quality of life as assessed by the 15D instrument (score range, 0-1; higher scores indicate better quality of life, with a minimum clinically important change of ±0.015) at week 16. Secondary outcomes included changes in medication appropriateness, physical and cognitive functioning, use of health services, and mortality.
Results


Among 174 patients (mean [SD] age, 83.3 [7.3] years; 67.8% women; 87 randomized to the intervention group and 87 randomized to the control [usual care] group) in 70 FP clusters (36 intervention and 34 control), 158 (90.8%) completed the trial. The mean (SD) 15D instrument score at baseline was 0.708 (0.121) in the intervention group and 0.714 (0.113) in the control group. At week 16, the mean (SD) 15D instrument score was 0.698 (0.164) in the intervention group and 0.655 (0.184) in the control group, with an estimated between-group difference of 0.045 (95% CI, 0.004-0.086; P = .03). Several secondary outcomes were also in favor of the intervention. There were more drug withdrawals, reduced dosages, and new drug regimens started in the intervention group.
Conclusions and Relevance


This study's findings indicate that, among older patients exposed to polypharmacy, clinical geriatric assessments and collaborative medication reviews carried out by a geriatrician in cooperation with the patient's FP can result in positive effects on health-related quality of life.
Trial Registration


ClinicalTrials.gov identifier: NCT02379455.",2020,"There were more drug withdrawals, reduced dosages, and new drug regimens started in the intervention group.
","['Home-Dwelling Older Patients Receiving Polypharmacy', 'older patients', 'older adults', 'Participants were home-dwelling patients 70 years or older, using at least 7 medications regularly, and having their medications administered by the home nursing service', 'home-dwelling older patients receiving polypharmacy', 'Norwegian FPs were recruited from March 17, 2015, to March 16, 2017, to participate in the trial with their eligible patients', '174 patients (mean [SD] age, 83.3 [7.3] years; 67.8% women; 87 randomized to the intervention group and 87 randomized to the control [usual care] group) in 70 FP clusters (36 intervention and 34 control), 158 (90.8%) completed the trial']","['geriatrician and family physician (FP', '3 main parts: (1) clinical geriatric assessment of the patients combined with a thorough review of their medications; (2) a meeting between the geriatrician and the FP; and (3) clinical follow-up', 'usual care', 'Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician']","['changes in medication appropriateness, physical and cognitive functioning, use of health services, and mortality', 'mean (SD) 15D instrument score', 'health-related quality of life as assessed by the 15D instrument (score range, 0-1; higher scores indicate better quality of life']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0019860', 'cui_str': 'Home Care, Nonprofessional'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0586872', 'cui_str': 'Gerontologists'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",87.0,0.067781,"There were more drug withdrawals, reduced dosages, and new drug regimens started in the intervention group.
","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Romskaug', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skovlund', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jørund', 'Initials': 'J', 'LastName': 'Straand', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Molden', 'Affiliation': 'School of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Kersten', 'Affiliation': 'School of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kaisu H', 'Initials': 'KH', 'LastName': 'Pitkala', 'Affiliation': 'Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Christofer', 'Initials': 'C', 'LastName': 'Lundqvist', 'Affiliation': 'Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Torgeir B', 'Initials': 'TB', 'LastName': 'Wyller', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5096']
909,31615937,"Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR + /HER2 -  Breast Cancer.","PURPOSE


neoMONARCH assessed the biological effects of abemaciclib in combination with anastrozole in the neoadjuvant setting.
PATIENTS AND METHODS


Postmenopausal women with stage I-IIIB HR + /HER2 -  breast cancer were randomized to a 2-week lead-in of abemaciclib, anastrozole, or abemaciclib plus anastrozole followed by 14 weeks of the combination. The primary objective evaluated change in Ki67 from baseline to 2 weeks of treatment. Additional objectives included clinical, radiologic, and pathologic responses, safety, as well as gene expression changes related to cell proliferation and immune response.
RESULTS


Abemaciclib, alone or in combination with anastrozole, achieved a significant decrease in Ki67 expression and led to potent cell-cycle arrest after 2 weeks of treatment compared with anastrozole alone. More patients in the abemaciclib-containing arms versus anastrozole alone achieved complete cell-cycle arrest (58%/68% vs. 14%,  P  < 0.001). At the end of treatment, following 2 weeks lead-in and 14 weeks of combination therapy, 46% of intent-to-treat patients achieved a radiologic response, with pathologic complete response observed in 4%. The most common all-grade adverse events were diarrhea (62%), constipation (44%), and nausea (42%). Abemaciclib, anastrozole, and the combination inhibited cell-cycle processes and estrogen signaling; however, combination therapy resulted in increased cytokine signaling and adaptive immune response indicative of enhanced antigen presentation and activated T-cell phenotypes.
CONCLUSIONS


Abemaciclib plus anastrozole demonstrated biological and clinical activity with generally manageable toxicities in patients with HR + /HER2 -  early breast cancer. Abemaciclib led to potent cell-cycle arrest, and in combination with anastrozole, enhanced immune activation.",2020,"The most common all-grade adverse events were diarrhea (62%), constipation (44%), and nausea (42%).","['Postmenopausal women with stage I-IIIB HR+/HER2-\u200a\u200a\u200abreast cancer', 'patients with HR+/HER2- early breast cancer', 'HR+/HER2- breast cancer']","['Abemaciclib plus anastrozole', 'Abemaciclib, anastrozole', 'anastrozole', 'abemaciclib, anastrozole, or abemaciclib plus anastrozole', 'abemaciclib and anastrozole']","['constipation', 'diarrhea', 'complete cell cycle arrest', 'Ki67 expression and led to potent cell cycle arrest', 'radiologic response', 'clinical, radiologic, and pathologic responses, safety, as well as gene expression changes related to cell proliferation and immune response', 'nausea']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1155873', 'cui_str': 'Cell Cycle Arrest'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.0407637,"The most common all-grade adverse events were diarrhea (62%), constipation (44%), and nausea (42%).","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California. shurvitz@mednet.ucla.edu.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Departamento de Medicina, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Press', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Cancer Care Associates, Redondo Beach, California.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fernandez-Abad', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Medical University Graz, Graz, Austria.'}, {'ForeName': 'Regan', 'Initials': 'R', 'LastName': 'Rostorfer', 'Affiliation': 'UF Health Cancer Center at Orlando Health, Orlando, Florida.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'University of Padova, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Barriga', 'Affiliation': 'Eli Lilly and Company, Madrid, Spain.'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Brahmachary', 'Affiliation': 'Eli Lilly and Company, New York, New York.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ebert', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Abel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Jansen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1425']
910,28916537,Reversibility of the effects of natalizumab on peripheral immune cell dynamics in MS patients.,"OBJECTIVE


To characterize the reversibility of natalizumab-mediated changes in pharmacokinetics/pharmacodynamics in patients with multiple sclerosis (MS) following therapy interruption.
METHODS


Pharmacokinetic/pharmacodynamic data were collected in the Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis (AFFIRM) (every 12 weeks for 116 weeks) and Randomized Treatment Interruption of Natalizumab (RESTORE) (every 4 weeks for 28 weeks) studies. Serum natalizumab and soluble vascular cell adhesion molecule-1 (sVCAM-1) were measured using immunoassays. Lymphocyte subsets, α4-integrin expression/saturation, and vascular cell adhesion molecule-1 (VCAM-1) binding were assessed using flow cytometry.
RESULTS


Blood lymphocyte counts (cells/L) in natalizumab-treated patients increased from 2.1 × 10 9  to 3.5 × 10 9 . Starting 8 weeks post last natalizumab dose, lymphocyte counts became significantly lower in patients interrupting treatment than in those continuing treatment (3.1 × 10 9  vs 3.5 × 10 9 ;  p  = 0.031), plateauing at prenatalizumab levels from week 16 onward. All measured cell subpopulation, α4-integrin expression/saturation, and sVCAM changes demonstrated similar reversibility. Lymphocyte counts remained within the normal range. Ex vivo VCAM-1 binding to lymphocytes increased until ≈16 weeks after the last natalizumab dose, then plateaued, suggesting reversibility of immune cell functionality. The temporal appearance of gadolinium-enhancing lesions was consistent with pharmacodynamic marker reversal.
CONCLUSIONS


Natalizumab's effects on peripheral immune cells and pharmacodynamic markers were reversible, with changes starting 8 weeks post last natalizumab dose; levels returned to those observed/expected in untreated patients ≈16 weeks post last dose. This reversibility differentiates natalizumab from MS treatments that require longer reconstitution times. Characterization of the time course of natalizumab's biological effects may help clinicians make treatment sequencing decisions.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that the pharmacodynamic markers of natalizumab are reversed ≈16 weeks after stopping natalizumab.",2017,"Ex vivo VCAM-1 binding to lymphocytes increased until ≈16 weeks after the last natalizumab dose, then plateaued, suggesting reversibility of immune cell functionality.","['MS patients', 'patients with multiple sclerosis (MS) following therapy interruption']","['natalizumab', 'Natalizumab']","['cell subpopulation, α4-integrin expression/saturation, and sVCAM changes demonstrated similar reversibility', 'peripheral immune cells and pharmacodynamic markers', 'Blood lymphocyte counts (cells/L', 'Lymphocyte subsets, α4-integrin expression/saturation, and vascular cell adhesion molecule-1 (VCAM-1) binding', 'peripheral immune cell dynamics', 'lymphocyte counts', 'Lymphocyte counts', 'Serum natalizumab and soluble vascular cell adhesion molecule-1 (sVCAM-1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449261', 'cui_str': 'Reversibility (attribute)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0005768'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0347983', 'cui_str': 'cells/liter'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}]",,0.133568,"Ex vivo VCAM-1 binding to lymphocytes increased until ≈16 weeks after the last natalizumab dose, then plateaued, suggesting reversibility of immune cell functionality.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plavina', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.). Tatiana.plavina@biogen.com.""}, {'ForeName': 'Kumar Kandadi', 'Initials': 'KK', 'LastName': 'Muralidharan', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Kuesters', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mikol', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Karleyton', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Subramanyam', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Nestorov', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Qunming', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Pei-Ran', 'Initials': 'PR', 'LastName': 'Ho', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Diogo', 'Initials': 'D', 'LastName': 'Amarante', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'De Sèze', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Jeffery', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Weinstock-Guttman', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': ""From Biogen (T.P., K.K.M., G.K., D.M., K.E., M.S., I.N., Y.C., Q.D., P.-R.H., D.A.), Cambridge, MA; Ashfield Healthcare Communications (A.A.), Middletown, CT; Hôpital Civil (J.D.S.), Strasbourg, France; Mellen Center for Multiple Sclerosis (R.F.), Cleveland Clinic, OH; St. Josef Hospital (R.G.), Ruhr University, Bochum, Germany; Piedmont HealthCare (D.J.), Mooresville, NC; Neurologic Clinic and Policlinic (L.K.), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Switzerland; Vall d'Hebron University Hospital (X.M.), Barcelona, Spain; Jacobs MS Center and Pediatric MS Center of Excellence (B.W.-G.), Jacobs Neurological Institute, Buffalo, NY; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany; and University of California San Francisco Multiple Sclerosis Center (B.A.C.C.).""}]",Neurology,['10.1212/WNL.0000000000004485']
911,29617440,The impact of serotype-specific vaccination on phylodynamic parameters of Streptococcus pneumoniae and the pneumococcal pan-genome.,"In the United States, the introduction of the heptavalent pneumococcal conjugate vaccine (PCV) largely eliminated vaccine serotypes (VT); non-vaccine serotypes (NVT) subsequently increased in carriage and disease. Vaccination also disrupts the composition of the pneumococcal pangenome, which includes mobile genetic elements and polymorphic non-capsular antigens important for virulence, transmission, and pneumococcal ecology. Antigenic proteins are of interest for future vaccines; yet, little is known about how the they are affected by PCV use. To investigate the evolutionary impact of vaccination, we assessed recombination, evolution, and pathogen demographic history of 937 pneumococci collected from 1998-2012 among Navajo and White Mountain Apache Native American communities. We analyzed changes in the pneumococcal pangenome, focusing on metabolic loci and 19 polymorphic protein antigens. We found the impact of PCV on the pneumococcal population could be observed in reduced diversity, a smaller pangenome, and changing frequencies of accessory clusters of orthologous groups (COGs). Post-PCV7, diversity rebounded through clonal expansion of NVT lineages and inferred in-migration of two previously unobserved lineages. Accessory COGs frequencies trended toward pre-PCV7 values with increasing time since vaccine introduction. Contemporary frequencies of protein antigen variants are better predicted by pre-PCV7 values (1998-2000) than the preceding period (2006-2008), suggesting balancing selection may have acted in maintaining variant frequencies in this population. Overall, we present the largest genomic analysis of pneumococcal carriage in the United States to date, which includes a snapshot of a true vaccine-naïve community prior to the introduction of PCV7. These data improve our understanding of pneumococcal evolution and emphasize the need to consider pangenome composition when inferring the impact of vaccination and developing future protein-based pneumococcal vaccines.",2018,"Post-PCV7, diversity rebounded through clonal expansion of NVT lineages and inferred in-migration of two previously unobserved lineages.",['937 pneumococci collected from 1998-2012 among Navajo and White Mountain Apache Native American communities'],['serotype-specific vaccination'],[],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}, {'cui': 'C0243030', 'cui_str': 'Acute Physiology and Chronic Health Evaluation'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.0583735,"Post-PCV7, diversity rebounded through clonal expansion of NVT lineages and inferred in-migration of two previously unobserved lineages.","[{'ForeName': 'Taj', 'Initials': 'T', 'LastName': 'Azarian', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, T.H. Chan School of Public Health, Harvard University; Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Lindsay R', 'Initials': 'LR', 'LastName': 'Grant', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; United States of America.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Arnold', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, T.H. Chan School of Public Health, Harvard University; Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Hammitt', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; United States of America.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Reid', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; United States of America.'}, {'ForeName': 'Mathuram', 'Initials': 'M', 'LastName': 'Santosham', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weatherholtz', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; United States of America.'}, {'ForeName': 'Novalene', 'Initials': 'N', 'LastName': 'Goklish', 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; United States of America.'}, {'ForeName': 'Claudette M', 'Initials': 'CM', 'LastName': 'Thompson', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, T.H. Chan School of Public Health, Harvard University; Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Bentley', 'Affiliation': 'Wellcome Trust Sanger Institute, Cambridge, United Kingdom.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': ""O'Brien"", 'Affiliation': 'Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; United States of America.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Hanage', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, T.H. Chan School of Public Health, Harvard University; Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lipsitch', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, T.H. Chan School of Public Health, Harvard University; Cambridge, Massachusetts, United States of America.'}]",PLoS pathogens,['10.1371/journal.ppat.1006966']
912,31302943,A Prospective Randomized Controlled Study of Oral Tranexamic Acid for the Prevention of Postinflammatory Hyperpigmentation After Q-Switched 532-nm Nd:YAG Laser for Solar Lentigines.,"BACKGROUND AND OBJECTIVES


Q-switched (QS) 532-nm Nd:YAG laser is one of the treatment options for solar lentigines (SLs). However, the high incidence of postinflammatory hyperpigmentation (PIH) is concerning, especially in dark-complexioned skin. Tranexamic acid (TA) can decrease melanogenesis and has been used to treat melasma. The aim of this study is to evaluate the efficacy and safety of oral TA for PIH prevention and clearance in patients with SL treated with QS 532-nm Nd:YAG laser.
STUDY DESIGN/MATERIALS AND METHODS


Forty patients with SL treated with QS 532-nm Nd:YAG laser were enrolled in this randomized controlled trial. They were randomly assigned to be receive oral TA 1,500 mg daily or placebo for 6 weeks. Results were evaluated by blinded investigators using digital photographs, dermatoscopy, colorimetry, physician grading scores, and patient satisfaction scores at baseline, 2nd, 4th, 6th, and 12th weeks.
RESULTS


The incidence of PIH, relative melanin value, lightness index, and clinical improvement scores were not significantly different between the two groups. However, the TA group had a significantly lower incidence of dermatoscopic finding of pigmented granules, which correspond to PIH at 6th and 12th weeks (P = 0.038 and 0.013, respectively). Homogenous light brown pigmentation under dermatoscopy was significantly associated with higher clinical improvement.
CONCLUSIONS


Oral TA therapy starting at the first day postlaser treatment is not effective for PIH prevention after QS 532-nm Nd:YAG laser in SL. However, PIH clearance, as assessed dermatoscopically, is significantly improved by oral TA at 6th and 12th week. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2019,"The incidence of PIH, relative melanin value, lightness index, and clinical improvement scores were not significantly different between the two groups.","['Solar Lentigines', '2019', 'Forty patients with SL treated with', 'solar lentigines (SLs', 'patients with SL treated with QS 532-nm']","['532-nm', 'Tranexamic acid (TA', 'QS 532-nm', 'Q-switched (QS', 'oral TA', 'oral TA 1,500\u2009mg daily or placebo', 'Nd:YAG laser', 'Oral Tranexamic Acid']","['Postinflammatory Hyperpigmentation', 'dermatoscopic finding of pigmented granules', 'incidence of PIH, relative melanin value, lightness index, and clinical improvement scores', 'digital photographs, dermatoscopy, colorimetry, physician grading scores, and patient satisfaction scores', 'efficacy and safety', 'PIH clearance']","[{'cui': 'C0036651', 'cui_str': 'Senile lentigo (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}]","[{'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation (morphologic abnormality)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0333610', 'cui_str': 'Pigmented (qualifier value)'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C1449565', 'cui_str': 'Dermoscopy'}, {'cui': 'C0009407', 'cui_str': 'Colorimetry'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",40.0,0.0552748,"The incidence of PIH, relative melanin value, lightness index, and clinical improvement scores were not significantly different between the two groups.","[{'ForeName': 'Suthinee', 'Initials': 'S', 'LastName': 'Rutnin', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Duangrat', 'Initials': 'D', 'LastName': 'Pruettivorawongse', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kunlawat', 'Initials': 'K', 'LastName': 'Thadanipon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Vasanop', 'Initials': 'V', 'LastName': 'Vachiramon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Lasers in surgery and medicine,['10.1002/lsm.23135']
913,27517842,Impact of emergency department care on outcomes of acute pain events in children with sickle cell disease.,"The impact of emergency department (ED) treatment on outcomes of sickle cell disease (SCD) acute pain hospitalizations is not well described. We investigated whether length of stay (LOS) and change in health-related quality of life (HRQL) are affected by initial opioid dose and time to administration. We conducted secondary analyses of data from the randomized-controlled Magnesium for children in Crisis (MAGiC) trial. The primary outcome was LOS. Secondary outcome was change in HRQL, assessed using PedsQL SCD Pain and Hurt and Pain Impact Domains measured in ED and at discharge. Independent variables were (1) time to first IV opioid, (2) total initial opioid dose (mg/kg/hr of morphine equivalents administered between ED and first study drug), and (3) Time to first oral opioid. Spearman correlations determined the associations with LOS. Using two-sample t-tests, we compared mean change in HRQL scores between IV opioid initiated within 60 and >60 min, opioid doses in the highest and lowest tertiles, and oral opioid initiated within 24 and >24 hr. Two hundred and four patients participated at 8 sites. Mean (SD) age was 13.6 (4.7) years. Earlier initiation of oral opioids was strongly correlated with shorter LOS (r = 0.61, P < 0.01). Higher initial opioid dose was weakly correlated with longer LOS (r = 0.34, P < 0.01). Higher initial opioid doses (6 vs -2.2; P = 0.01) and oral opioids initiated within 24 hr (5.7 vs -1.7, P = 0.04) were associated with larger mean change in HRQL at discharge. Prospective trials evaluating the impact of ED care on outcomes of pain hospitalizations could improve SCD pain treatment. Am. J. Hematol. 91:1175-1180, 2016. © 2016 Wiley Periodicals, Inc.",2016,"Earlier initiation of oral opioids was strongly correlated with shorter LOS (r = 0.61, P < 0.01).","['children with sickle cell disease', '2016', 'children in Crisis (MAGiC) trial', 'Two hundred and four patients participated at 8 sites']","['emergency department care', 'Magnesium', 'emergency department (ED) treatment']","['length of stay (LOS) and change in health-related quality of life (HRQL', 'SCD pain treatment', 'LOS', 'sickle cell disease (SCD) acute pain hospitalizations', 'acute pain events', 'change in HRQL, assessed using PedsQL SCD Pain and Hurt and Pain Impact Domains measured in ED and at discharge', 'HRQL scores', 'shorter LOS', 'oral opioids']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",204.0,0.157874,"Earlier initiation of oral opioids was strongly correlated with shorter LOS (r = 0.61, P < 0.01).","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Brandow', 'Affiliation': ""Pediatric Hematology/Oncology, Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin, Milwaukee, Wiconsin.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nimmer', 'Affiliation': ""Pediatric Emergency Medicine, Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin Milwaukee, Wisconsin.""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Simmons', 'Affiliation': 'University of Utah/Pediatric Emergency Care Applied Research Network Data Coordinating Center, Salt Lake City, Utah.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Charles Casper', 'Affiliation': 'University of Utah/Pediatric Emergency Care Applied Research Network Data Coordinating Center, Salt Lake City, Utah.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Cook', 'Affiliation': 'University of Utah/Pediatric Emergency Care Applied Research Network Data Coordinating Center, Salt Lake City, Utah.'}, {'ForeName': 'Corrie E', 'Initials': 'CE', 'LastName': 'Chumpitazi', 'Affiliation': 'Pediatric Emergency Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Paul Scott', 'Affiliation': ""Pediatric Hematology/Oncology, Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin, Milwaukee, Wiconsin.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Panepinto', 'Affiliation': ""Pediatric Hematology/Oncology, Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin, Milwaukee, Wiconsin.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Brousseau', 'Affiliation': ""Pediatric Emergency Medicine, Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin Milwaukee, Wisconsin.""}]",American journal of hematology,['10.1002/ajh.24534']
914,31561272,Subepithelial connective tissue graft with or without enamel matrix derivative for the treatment of multiple Class III-IV recessions in lower anterior teeth: A 3-year randomized clinical trial.,"BACKGROUND


This study compared clinical and patient-centered outcomes of subepithelial connective tissue graft (CTG) with and without enamel matrix derivative (EMD) in the treatment of multiple Class III-IV Miller periodontal recession (REC) defects on mandibular anterior teeth.
METHODS


This randomized clinical study evaluated 41 patients at 3 years follow-up. One hundred and fifty-six teeth were divided into two groups: test (CTG-EMD, 79 teeth) and control (CTG only, 77 teeth). Clinical REC, keratinized tissue (KT) width, percentage of root coverage, patient-centered outcomes were compared between the two groups.
RESULTS


At 36 months follow-up, patient level analysis showed that REC in the test group reduced significantly (5.71 ± 0.58 mm to 1.57 ± 0.85 mm) compared with the control group (5.94 ± 0.46 mm to 2.51 ± 0.62 mm) (P < 0.001), while KT width increased in the test group (1.51 ± 0.26 mm to 4.18 ± 0.34 mm) and was significantly greater than the control group (1.65 ± 0.21 mm to 2.90 ± 0.20 mm) (P < 0.001). At 36 months, tooth level analysis (Class III and Class IV groups) found less residual REC and increased KT in the test group compared with the control group (P < 0.01). Significantly less pain was reported at 2, 7, and 14 days follow-up post-surgery in the test group (P < 0.001).
CONCLUSIONS


The addition of EMD to CTG results in improved root coverage outcomes and higher amounts of KT width 36 months after treatment of Class III-IV REC on mandibular anterior teeth. The adjunctive use of EMD also resulted in significantly reduced pain 14 days post-surgery.",2020,"Significantly less pain was reported at 2 nd  , 7 th  and 14 days follow-up post-surgery in the test group (p<0.001).
","['41 patients over 3 years follow up', '156 teeth', 'multiple Class III-IV recessions in lower anterior teeth', 'Multiple Class III-IV Miller periodontal recession defects on lower anterior teeth']","['sub-epithelial connective tissue graft (CTG) with and without enamel matrix derivative (EMD', 'Sub-epithelial connective tissue graft with or without enamel matrix derivative', 'EMD']","['residual REC and increased KT', 'Clinical Recession (REC), Keratinized Tissue (KT) width, % root coverage, patient centered outcomes', 'pain', 'KT width increase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior (qualifier value)'}, {'cui': 'C0402830', 'cui_str': 'Miller (occupation)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",156.0,0.0489282,"Significantly less pain was reported at 2 nd  , 7 th  and 14 days follow-up post-surgery in the test group (p<0.001).
","[{'ForeName': 'Faustino', 'Initials': 'F', 'LastName': 'Mercado', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hamlet', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Saso', 'Initials': 'S', 'LastName': 'Ivanovski', 'Affiliation': 'School of Dentistry, University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of periodontology,['10.1002/JPER.19-0058']
915,31594690,GLPG2737 in lumacaftor/ivacaftor-treated CF subjects homozygous for the F508del mutation: A randomized phase 2A trial (PELICAN).,"BACKGROUND


Triple combinations of cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulators demonstrate enhanced clinical efficacy in CF patients with F508del mutation, compared with modest effects of dual combinations. GLPG2737 was developed as a novel corrector for triple combination therapy.
METHODS


This multicenter, randomized, double-blind, placebo-controlled, phase 2a study evaluated GLPG2737 in F508del homozygous subjects who had been receiving lumacaftor 400mg/ivacaftor 250mg for ≥12weeks. The primary outcome was change from baseline in sweat chloride concentration. Other outcomes included assessment of pulmonary function, respiratory symptoms, safety, tolerability, and pharmacokinetics.
RESULTS


Between November 2017 and April 2018, 22 subjects were enrolled and randomized to oral GLPG2737 (75mg; n=14) or placebo (n=8) capsules twice daily for 28days. A significant decrease from baseline in mean sweat chloride concentration occurred at day 28 for GLPG2737 versus placebo (least-squares-mean difference-19.6mmol/L [95% confidence interval (CI) -36.0, -3.2], p=.0210). The absolute improvement, as assessed by least-squares-mean difference in change from baseline, in forced expiratory volume in 1s (percent predicted) at day 28 for GLPG2737 versus placebo was 3.4% (95% CI -0.5, 7.3). Respiratory symptoms in both groups remained stable. Mild/moderate adverse events occurred in 10 (71.4%) and 8 (100%) subjects receiving GLPG2737 and placebo, respectively. Lower exposures of GLPG2737 (and active metabolite M4) were observed than would be expected if administered alone (as lumacaftor induces CYP3A4). Lumacaftor and ivacaftor exposures were as expected.
CONCLUSIONS


GLPG2737 was well tolerated and yielded significant decreases in sweat chloride concentration versus placebo in subjects homozygous for F508del receiving lumacaftor/ivacaftor, demonstrating evidence of increased CFTR activity when added to a potentiator-corrector combination.
FUNDING


Galapagos NV.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03474042.",2020,A significant decrease from baseline in mean sweat chloride concentration occurred at day 28 for GLPG2737 versus placebo (least-squares-mean difference-19.6mmol/L,"['Between November 2017 and April 2018, 22 subjects', 'CF patients with F508del mutation', 'F508del homozygous subjects who had been receiving lumacaftor 400mg/ivacaftor 250mg for ≥12weeks']","['GLPG2737', 'placebo', 'GLPG2737 versus placebo', 'oral GLPG2737']","['sweat chloride concentration', 'pulmonary function, respiratory symptoms, safety, tolerability, and pharmacokinetics', 'Respiratory symptoms', 'forced expiratory volume', 'CFTR activity', 'mean sweat chloride concentration', 'Mild/moderate adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C3852684', 'cui_str': 'lumacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",22.0,0.743982,A significant decrease from baseline in mean sweat chloride concentration occurred at day 28 for GLPG2737 versus placebo (least-squares-mean difference-19.6mmol/L,"[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'van Koningsbruggen-Rietschel', 'Affiliation': ""Cystic Fibrosis Center, Children's Hospital, University of Cologne, Faculty of Medicine and University Hospital Cologne, Germany. Electronic address: Silke.vanKoningsbruggen@uk-koeln.de.""}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Conrath', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Rainald', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'Cystic Fibrosis Center Munich-West, Munich, Germany.'}, {'ForeName': 'Sivagurunathan', 'Initials': 'S', 'LastName': 'Sutharsan', 'Affiliation': 'Cystic Fibrosis Division, Department of Pulmonary Medicine, University of Essen, University Duisburg-Essen, Ruhrlandklinik, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Kempa', 'Affiliation': 'Cystic Fibrosis Center, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gleiber', 'Affiliation': 'Cystic Fibrosis Center, Department of Pulmonary Medicine, University Hospital, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwarz', 'Affiliation': 'Cystic Fibrosis Center, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hector', 'Affiliation': ""Children's Hospital of the University of Tübingen, Tübingen, Germany.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Osselaer', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Pano', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Corveleyn', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Dieudonné', 'Initials': 'D', 'LastName': 'Bwirire', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Santermans', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Muller', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bellaire', 'Affiliation': 'Galapagos BV, Leiden, The Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Van de Steen', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.09.006']
916,30866175,A randomized controlled trial to assess operator radiation exposure from cardiac catheterization procedures using RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone.,"OBJECTIVE


To study radiation exposure to the primary operator during diagnostic cardiac catheterizations using a radio-dense RAD BOARD® radial access arm board.
BACKGROUND


The use of radial access for catheterization in the United States has increased from 1% in 2007 to 41% in 2018. Compared to femoral access, operator radiation exposure from radial access is similar or higher. The RAD BOARD radio-dense radial access arm board has been marketed as reducing radiation to operators by 44%.
MATERIALS AND METHODS


We randomized 265 patients undergoing catheterization via right radial access to standard pelvic lead drape shielding (nonboard group) versus RAD BOARD in addition to pelvic drape (board group). Operator radiation exposure was measured using Landauer Microstar nanoDot™ badges worn by the operator.
RESULTS


Board and nonboard groups were similar with respect to demographic and procedural variables. Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001). In sub-group analyses, radiation doses were higher in the board group compared to the nonboard group in patients across all body mass index groups (P < 0.03). In multivariate analysis, operator dose correlated with use of the RAD BOARD more closely than any other variable (P < 0.001). Post hoc analysis of the table setup with RAD BOARD revealed that use of RAD BOARD prevented placement of a shield normally inserted into the top of the standard below-table shield.
CONCLUSION


RAD BOARD with the pelvic shield was associated with higher radiation exposure to the operator compared with pelvic shield alone, likely due to inability to use standard radiation shielding along with the RAD BOARD.",2020,"Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001).",['265 patients undergoing'],"['RAD BOARD® with standard pelvic shielding versus standard pelvic shielding alone', 'catheterization via right radial access to standard pelvic lead drape shielding (nonboard group) versus RAD BOARD']",['Mean operator dose per case'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",265.0,0.0793785,"Mean operator dose per case was higher in the board group (.65mSieverts) than in the nonboard group (.56mSieverts, P < 0.0001).","[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Suryadevara', 'Affiliation': 'Department of Cardiology, Harton Regional Medical Center, Tullahoma, Tennessee.'}, {'ForeName': 'Eddie D', 'Initials': 'ED', 'LastName': 'Brown', 'Affiliation': 'Department of Cardiology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Sandy M', 'Initials': 'SM', 'LastName': 'Green', 'Affiliation': 'Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Scott', 'Affiliation': 'Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Nordberg', 'Affiliation': 'Department of Biomedical and Translational Informatics, Geisinger Health System, Danville, Pennsylvania.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Blankenship', 'Affiliation': 'Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28190']
917,31588804,Glycemic impact of a diet and lifestyle intervention on diabetics and prediabetics during treatment for non-muscle invasive bladder cancer.,"Introduction:  Patients with Type II Diabetes Mellitus (DM2) have increased risk of recurrence and progression of non-muscle invasive bladder cancer (NMIBC). Glucose control through lifestyle intervention is an uninvestigated, attractive strategy to decrease risk of cancer recurrence. We test the feasibility of a diet and exercise program and its glycemic impact in patients with DM2 and NMIBC. Materials/methods:  Five participants with NMIBC and pre-diabetes or DM2 were recruited for a pilot, prospective clinical trial. Each participant received dietary counseling for 16 sessions during clinical visits. The intervention included a carbohydrate-restricted (CR) diet (<130 grams per day), 30 min, walking 5×/wk, and 5000 steps daily. Diet compliance was measured with 24-hour diet recall. Exercise was monitored with accelerometer and self-report. Results:  Five participants enrolled and two participants completed the 12-month intervention. Adherence was 60% to CR diet and 84% to exercise goals. Participants reduced carbohydrate consumption by 44%. Participants showed reductions in fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring. Conclusions:  Adherence to a CR diet and exercise goals is feasible in patients with NMIBC and DM2 and also leads improved glucose control. A phase-II trial on bladder cancer-specific outcomes is warranted.",2020,"Participants showed reductions in fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring.  ","['patients with DM2 and NMIBC', 'Five participants with NMIBC and pre-diabetes or DM2', 'non-muscle invasive bladder cancer', 'patients with NMIBC and DM2', 'Patients with Type II Diabetes', 'Five participants enrolled and two participants completed the 12-month intervention']","['Glucose control through lifestyle intervention', 'diet and exercise program', 'dietary counseling', 'diet and lifestyle intervention', 'carbohydrate-restricted (CR) diet']","['risk of cancer recurrence', 'carbohydrate consumption', 'fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring', 'Adherence', 'diabetics and prediabetics', 'Diet compliance', 'risk of recurrence and progression of non-muscle invasive bladder cancer (NMIBC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]",5.0,0.025133,"Participants showed reductions in fasting blood glucose, HbA1c, glucosuria, fasting blood insulin, and body weight, and increased euglycemia on continuous glucose monitoring.  ","[{'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Chestnut', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Woodson', 'Initials': 'W', 'LastName': 'Smelser', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Dum', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Misty', 'Initials': 'M', 'LastName': 'Bechtel', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hand', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Michel', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'Bawajeeh', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Zohreh', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Weiya', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Shrikant', 'Initials': 'S', 'LastName': 'Anant', 'Affiliation': 'Department of Cancer Biology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robbins', 'Affiliation': 'Department of Internal Medicine, Diabetes Institute, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Holzbeierlein', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hamilton-Reeves', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Eugene K', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, University of Kansas Medical Center, Kansas City, KS, USA.'}]",Nutrition and cancer,['10.1080/01635581.2019.1672761']
918,31808352,"Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled study.","OBJECTIVE


To evaluate the effects of insoles adapted into flip-flop sandals on pain and function in individuals with plantar fasciopathy (PF).
DESIGN


Randomized, double-blind controlled study.
SETTING


Physiotherapy clinic of the Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte, Santa Cruz, Brazil.
SUBJECTS


Sixty-six patients of both genders with PF were randomized into two groups: sandal insole group (SI;  n  = 34), which received a pair of custom flip-flop sandals with insoles covered with smooth synthetic leather; and plain sandal group (PS;  n  = 32), which received an identical pair of flip-flop sandals, but without the insoles.
INTERVENTIONS


Patients were instructed to wear the flip-flops for 12 weeks for at least 4 hours/day.
MAIN MEASURES


Pain (visual analogue scale-VAS) in the morning and at the end of the day were considered primary outcomes. Function (Foot Function Index-FFI and Foot and Ankle Ability Measure-FAAM) and functional capacity (6-minute walk test-6MWT) were considered secondary outcomes. The outcomes were evaluated at baseline and immediately after the intervention by a blind assessor.
RESULTS


Between-group differences were observed in terms of morning pain (mean difference (MD) = -1.82 cm; 95% confidence interval (CI) = -3.3 to -0.3;  P  = 0.016) and function (MD = -0.10; 95% CI = -0.19 to -0.01;  P  = 0.023) after the interventions with the SI group showing superior improvements in comparison to the PS group.
CONCLUSION


The use of insoles adapted in flip-flop sandals for 12 weeks was effective at improving pain and function in individuals with PF.
LEVEL OF EVIDENCE


1b.",2020,"The use of insoles adapted in flip-flop sandals for 12 weeks was effective at improving pain and function in individuals with PF.
","['Physiotherapy clinic of the Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte, Santa Cruz, Brazil', 'Sixty-six patients of both genders with PF', 'individuals with plantar fasciopathy (PF', 'people with plantar fasciopathy', 'individuals with PF']","['sandal insole group (SI;  n \u2009=\u200934), which received a pair of custom flip-flop sandals with insoles covered with smooth synthetic leather; and plain sandal group (PS;  n \u2009=\u200932), which received an identical pair of flip-flop sandals, but without the insoles', 'insoles adapted in flip-flop sandals', 'insoles adapted into flip-flop sandals']","['Pain (visual analogue scale-VAS', 'Function (Foot Function Index-FFI and Foot and Ankle Ability Measure-FAAM) and functional capacity (6-minute walk test-6MWT', 'morning pain', 'pain and function']","[{'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0445581', 'cui_str': 'Rio (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}]","[{'cui': 'C0453964', 'cui_str': 'Sandals (physical object)'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0540654', 'cui_str': 'FLICE-Inhibitory Protein'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0336889', 'cui_str': 'Leather (physical object)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}]",,0.395236,"The use of insoles adapted in flip-flop sandals for 12 weeks was effective at improving pain and function in individuals with PF.
","[{'ForeName': 'Ana Rafaella Araújo', 'Initials': 'ARA', 'LastName': 'Costa', 'Affiliation': 'Faculty of Health Sciences of Trairi (FACISA), Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Brazil.'}, {'ForeName': 'Hugo Jário', 'Initials': 'HJ', 'LastName': 'de Almeida Silva', 'Affiliation': 'Faculty of Health Sciences of Trairi (FACISA), Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Brazil.'}, {'ForeName': 'André Augusto Martines Teixeira', 'Initials': 'AAMT', 'LastName': 'Mendes', 'Affiliation': 'Faculty Anhanguera de Taubaté, Taubaté, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Scattone Silva', 'Affiliation': 'Faculty of Health Sciences of Trairi (FACISA), Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Brazil.'}, {'ForeName': 'Caio Alano', 'Initials': 'CA', 'LastName': 'de Almeida Lins', 'Affiliation': 'Faculty of Health Sciences of Trairi (FACISA), Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Brazil.'}, {'ForeName': 'Marcelo Cardoso', 'Initials': 'MC', 'LastName': 'de Souza', 'Affiliation': 'Faculty of Health Sciences of Trairi (FACISA), Federal University of Rio Grande do Norte (UFRN), Santa Cruz, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215519893104']
919,32415471,Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial.,"PURPOSE


Primary dysmenorrhea is the most common gynecological problem in young women and adolescents. Exercise therapy provides positive effects on women with primary dysmenorrhea. The aim of the study was to investigate the effects of a combined exercise program on pain, sleep and menstrual symptoms in patients with primary dysmenorrhea.
METHODS


The study is a randomized controlled study. The study included 28 sedentary individuals. The participants were assigned to two groups as the exercise (mean age 22.9 ± 2.0 years) and the control (mean age 23.1 ± 1.8 years) groups. The exercise protocol was carried out with the exercise group three times a week for eight weeks. The Visual Analog Scale (VAS) was used for assessing the intensity of pain. The Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI) were used for evaluating menstrual symptoms and sleep quality, respectively. The study was registered on the Clinical Trials website by the number NCT03625375.
RESULTS


The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05). The intragroup comparisons of the exercise group demonstrated that the scores of the low back pain and abdominal pain and the MSQ and PSQI scores were found to be significantly different after the 8-week program (p < 0.05).
CONCLUSION


The combined exercise therapy is an effective way to manage symptoms associated with primary dysmenorrhea.",2020,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","['young women and adolescents', 'patients with primary dysmenorrhea', 'women with primary dysmenorrhea', '28 sedentary individuals']","['functional exercises', 'combined exercise program', 'Exercise therapy', 'combined exercise therapy']","['Visual Analog Scale (VAS', 'Menstrual Symptom Questionnaire (MSQ) and Pittsburgh Sleep Quality Index (PSQI', 'low back pain and abdominal pain and the MSQ and PSQI scores', 'pain, sleep and menstrual symptoms', 'abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods', 'menstrual symptoms and sleep quality', 'pain and sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",28.0,0.0352192,"The comparisons between the groups revealed statistically significant differences in abdominal pain severity, MSQ total score and the subscale scores of negative outcomes and management methods (p < 0.05).","[{'ForeName': 'Berkiye', 'Initials': 'B', 'LastName': 'Kirmizigil', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey. berkiye.kirmizigil@emu.edu.tr.'}, {'ForeName': 'Cisel', 'Initials': 'C', 'LastName': 'Demiralp', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Eastern Mediterranean University, Famagusta, North Cyprus, via Mersin-10, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05579-2']
920,31807943,Does helping mothers in multigenerational ADHD also help children in the long run? 2-year follow-up from baseline of the AIMAC randomized controlled multicentre trial.,"ADHD often affects multiple generations in a family. Previous studies suggested that children with ADHD benefit less from therapy if parents are also affected, since ADHD symptoms interfere with treatment implementation. This two-group randomised controlled trial examined whether targeting maternal ADHD boosts the efficacy of parent-child training (PCT) for the child's ADHD. Here, we report follow-up results 2 years from baseline. Mothers of 144 mother-child dyads (ADHD according to DSM-IV) were examined for eligibility (T1) and randomised to 12 weeks of intensive multimodal treatment comprising pharmacotherapy and DBT-based cognitive behavioural group psychotherapy (TG, n = 77) or clinical management comprising non-specific counselling (CG, n = 67) for Step 1 (concluded by T2). Subsequently, all dyads participated in 12 weekly PCT sessions for Step 2 (concluded by T3). In Step 3, participants received maintenance treatments for 6 months (concluded by T4). At 24 months after baseline (T5), we performed follow-up assessments. The primary endpoint was child ADHD/ODD score (observer blind rating). Outcomes at T5 were evaluated using ANCOVA. Assessments from 101 children and 95 mothers were available at T5. Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1). The maternal advantage of TG over CG on the CAARS-O:L ADHD index (range 0-36) disappeared at T5 (mean difference = 0.2; 95% CI - 2.3 to 2.6). Sensitivity analyses controlling for medication and significant predictors of follow-up participation showed unchanged outcomes. Within-group outcomes remained improved from baseline. At the 24-month follow-up, TG and CG converged. The superiority of intensive treatment regarding maternal symptoms disappeared. In general, cross-generational treatment seems to be effective in the long term. (BMBF grant 01GV0605; registration ISRCTN73911400).",2020,Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1).,"['101 children and 95 mothers', 'Mothers of 144 mother-child dyads (ADHD according to DSM-IV']","['parent-child training (PCT', 'intensive multimodal treatment comprising pharmacotherapy and DBT-based cognitive behavioural group psychotherapy (TG, n\u2009=\u200977) or clinical management comprising non-specific counselling (CG, n\u2009=\u200967) for Step 1 (concluded by T2']","['Adjusted means (m) of ADHD/ODD symptoms', 'child ADHD/ODD score (observer blind rating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",144.0,0.156423,Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1).,"[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Geissler', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany. Geissler_J@ukw.de.'}, {'ForeName': 'Timo D', 'Initials': 'TD', 'LastName': 'Vloet', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Strom', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jaite', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Graf', 'Affiliation': 'Institute of Medical Biometry and Statistics, Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Kappel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Warnke', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hennighausen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Haack-Dees', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Schneider-Momm', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rösler', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Retz', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Hänig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'von Gontard', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hohmann', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Poustka', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colla', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gentschow', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Freitag', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holtmann', 'Affiliation': 'Hospital for Child and Adolescent Psychiatry, LWL University Hospital Hamm of the Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jans', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01451-0']
921,26449197,The design and implementation of a study to investigate the effectiveness of community vs hospital eye service follow-up for patients with neovascular age-related macular degeneration with quiescent disease.,"IntroductionStandard treatment for neovascular age-related macular degeneration (nAMD) is intravitreal injections of anti-VEGF drugs. Following multiple injections, nAMD lesions often become quiescent but there is a high risk of reactivation, and regular review by hospital ophthalmologists is the norm. The present trial examines the feasibility of community optometrists making lesion reactivation decisions.MethodsThe Effectiveness of Community vs Hospital Eye Service (ECHoES) trial is a virtual trial; lesion reactivation decisions were made about vignettes that comprised clinical data, colour fundus photographs, and optical coherence tomograms displayed on a web-based platform. Participants were either hospital ophthalmologists or community optometrists. All participants were provided with webinar training on the disease, its management, and assessment of the retinal imaging outputs. In a balanced design, 96 participants each assessed 42 vignettes; a total of 288 vignettes were assessed seven times by each professional group.The primary outcome is a participant's judgement of lesion reactivation compared with a reference standard. Secondary outcomes are the frequency of sight threatening errors; judgements about specific lesion components; participant-rated confidence in their decisions about the primary outcome; cost effectiveness of follow-up by optometrists rather than ophthalmologists.DiscussionThis trial addresses an important question for the NHS, namely whether, with appropriate training, community optometrists can make retreatment decisions for patients with nAMD to the same standard as hospital ophthalmologists. The trial employed a novel approach as participation was entirely through a web-based application; the trial required very few resources compared with those that would have been needed for a conventional randomised controlled clinical trial.",2016,Secondary outcomes are the frequency of sight threatening errors; judgements about specific lesion components; participant-rated confidence in their decisions about the primary outcome; cost effectiveness of follow-up by optometrists rather than ophthalmologists.,"['patients with nAMD to the same standard as hospital ophthalmologists', 'Participants were either hospital ophthalmologists or community optometrists', '96 participants each assessed 42 vignettes; a total of 288 vignettes were assessed seven times by each professional group', 'patients with neovascular age-related macular degeneration with quiescent disease', 'neovascular age-related macular degeneration (nAMD']","['webinar training', 'community vs hospital eye service follow-up', 'Community vs Hospital Eye Service (ECHoES']","['frequency of sight threatening errors; judgements about specific lesion components; participant-rated confidence in their decisions about the primary outcome; cost effectiveness of follow-up by optometrists rather than ophthalmologists', ""participant's judgement of lesion reactivation""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologists'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029146', 'cui_str': 'Optometrist'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologists'}]",288.0,0.181963,Secondary outcomes are the frequency of sight threatening errors; judgements about specific lesion components; participant-rated confidence in their decisions about the primary outcome; cost effectiveness of follow-up by optometrists rather than ophthalmologists.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""Centre for Experimental Medicine, The Queen's University of Belfast, Belfast, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': ""Centre for Public Health, The Queen's University of Belfast, Belfast, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Nuffield Department of Population Health, Health Economic Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Unit of Health Care Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hogg', 'Affiliation': ""Centre for Experimental Medicine, The Queen's University of Belfast, Belfast, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Violato', 'Affiliation': 'Nuffield Department of Population Health, Health Economic Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Townsend', 'Affiliation': 'Unit of Health Care Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Centre for Experimental Medicine, The Queen's University of Belfast, Belfast, UK.""}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}]","Eye (London, England)",['10.1038/eye.2015.170']
922,27022068,Comparison of prognostic and predictive impact of genomic or central grade and immunohistochemical subtypes or IHC4 in HR+/HER2- early breast cancer: WSG-AGO EC-Doc Trial.,"INTRODUCTION


Potential prognostic and predictive markers in early, intermediate-risk breast cancer (BC) include histological grade, Ki-67, genomic signatures, e.g. genomic grade index (GGI), and intrinsic subtypes. Their prognostic/predictive impact in hormone receptor (HR: ER and/or PR) positive/HER2- BC is controversial. WSG-AGO EC-Doc demonstrated superior event-free survival (EFS) in patients with 1-3 positive lymph node receiving epirubicin/cyclophosphamide-docetaxel (EC-Doc) versus 5-fluoruracil/epirubicin/cyclophosphamide (FEC).
METHODS


In a representative trial subset, we quantify concordance among factors used for clinical chemotherapy indication. We investigate the impact of central histology (n = 772), immunohistochemistry for intrinsic subtyping and IHC4, and dichotomous (GG) or continuous (GGI) genomic grade (n = 472) on patient outcome and benefit from taxane chemotherapy, focusing on HR+/HER2- patients (n = 459).
RESULTS


Concordance of local grade (LG) with central (CG) or genomic grade was modest. In HR+/HER2- patients, low (GG-1: 16%), equivocal (GG-EQ: 17%), and high (GG-3: 67%) GG were associated with respective 5-year EFS of 100%, 93%, and 85%. GGI was prognostic for EFS within all LG subgroups and within CG3, whereas IHC4 was prognostic only in CG3 tumors.In unselected and HR+/HER2- patients, CG3 and luminal-A-like subtype entered the multivariate EFS model, but not IHC4 or GG. In the whole population, continuous GGI entered the model [hazard ratio (H.R.) of 75th versus 25th = 2.79; P = 0.01], displacing luminal-A-like subtype; within HR+/HER2- (H.R. = 5.36; P < 0.001), GGI was the only remaining prognostic factor.In multivariate interaction analysis (including central and genomic grade), luminal-B-like subtype [HR+ and (Ki-67 ≥20% or HER2+)] was predictive for benefit of EC-Doc versus FEC in unselected but not in HR+/HER2- patients.
CONCLUSION


In the WSG-AGO EC-Doc trial for intermediate-risk BC, CG, intrinsic subtype (by IHC), and GG provide prognostic information. Continuous GGI (but not IHC4) adds prognostic information even when IHC subtype and CG are available. Finally, the high interobserver variability for histological grade and the still missing validation of Ki-67 preclude indicating or omitting adjuvant chemotherapy based on these single factors alone.
TRIAL REGISTRATION


The WSG-AGO/EC-Doc is registered at ClinicalTrials.gov, NCT02115204.",2016,"WSG-AGO EC-Doc demonstrated superior event-free survival (EFS) in patients with 1-3 positive lymph node receiving epirubicin/cyclophosphamide-docetaxel (EC-Doc) versus 5-fluoruracil/epirubicin/cyclophosphamide (FEC).
","['patients with 1-3 positive lymph node receiving', 'HR+/HER2- early breast cancer', 'patients (n = 459']","['Continuous GGI (but not IHC4', 'epirubicin/cyclophosphamide-docetaxel (EC-Doc) versus 5-fluoruracil/epirubicin/cyclophosphamide (FEC', 'IHC4', 'taxane chemotherapy, focusing on HR+/HER2']","['respective 5-year EFS', 'superior event-free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0011710', 'cui_str': 'desoxycortone'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",772.0,0.0694194,"WSG-AGO EC-Doc demonstrated superior event-free survival (EFS) in patients with 1-3 positive lymph node receiving epirubicin/cyclophosphamide-docetaxel (EC-Doc) versus 5-fluoruracil/epirubicin/cyclophosphamide (FEC).
","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gluz', 'Affiliation': 'West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach. Electronic address: oleg.gluz@wsg-online.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liedtke', 'Affiliation': ""West German Study Group, Moenchengladbach; Women's Clinic, University Clinics Schleswig-Holstein, Luebeck.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen; Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Peyro-Saint-Paul', 'Affiliation': 'Sample & Assay Technologies, QIAGEN, Marseille, France.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Kates', 'Affiliation': 'West German Study Group, Moenchengladbach.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Kreipe', 'Affiliation': 'Institute of Pathology, Hannover Medical School, Hannover.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Institute of Pathology, University Clinics Erlangen, Erlangen, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pelz', 'Affiliation': 'Institute of Pathology Viersen, Viersen.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Institute of Pathology, University Clinics Erlangen, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mohrmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Heinrich-Heine-University Duesseldorf, Duesseldorf.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': 'Department of Obstetrics and Gynecology, Staedtisches Klinikum, Frankfurt.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Augustin', 'Affiliation': 'Clinics Deggendorf Mammacenter Ostbayern, Deggendorf.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Gynecology and Obstetrics, St Josephs-Hospital, Wiesbaden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thomssen', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg; Department of Gynecology, University Hospital Halle/Saale, Halle.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Jänicke', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kiechle', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Rechts der Isar der Technischen Universität Muenchen (TUM), Munich.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wallwiener', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Kuhn', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Bonn, Bonn.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Nitz', 'Affiliation': 'West German Study Group, Moenchengladbach; Breast Center Niederrhein, Ev. Bethesda Hospital, Moenchengladbach.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'West German Study Group, Moenchengladbach; Breast Center, University of Munich and CCC of LMU, Munich, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw070']
923,28428158,Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development.,"BACKGROUND


Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management.
OBJECTIVE


The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer.
METHODS


We used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial.
RESULTS


We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects. At every stage in this trial, we are engaging stakeholders to solicit feedback on our progress and next steps.
CONCLUSIONS


To our knowledge, we are the first to describe the development of an app designed for people taking oral chemotherapy. The app addresses many concerns with oral chemotherapy, such as medication adherence and symptom management. Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians. In our development process, we instantiated 7 of the 8 best practices proposed in a recent review of mobile health app development. Our process demonstrated the importance of effective communication between research groups and technical teams, as well as meticulous planning of technical specifications before development begins. Future efforts should consider incorporating other proven strategies in software, such as gamification, to bolster the impact of mobile health apps. Forthcoming results from our randomized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02157519; https://clinicaltrials.gov/ct2/show/NCT02157519 (Archived by WebCite at http://www.webcitation.org/6prj3xfKA).",2017,"Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians.","['patients with cancer prescribed oral chemotherapy regimens', 'patients with cancer']","['smartphone app', 'Oral Chemotherapy and Symptom Management']","['medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback', 'adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects', 'usability and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy (procedure)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy (procedure)'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023621', 'cui_str': 'Libraries'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0791118,"Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians.","[{'ForeName': 'Joel Nathan', 'Initials': 'JN', 'LastName': 'Fishbein', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Lauren Ellen', 'Initials': 'LE', 'LastName': 'Nisotel', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, United States.'}, {'ForeName': 'James John', 'Initials': 'JJ', 'LastName': 'MacDonald', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Amoyal Pensak', 'Affiliation': 'Anschutz Medical Campus, Department of Medicine, University of Colorado Denver, Denver, CO, United States.'}, {'ForeName': 'Jamie Michele', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Flanagan', 'Affiliation': 'Partners Connected Health, Partners HealthCare, Boston, MA, United States.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Jethwani', 'Affiliation': 'Partners Connected Health, Partners HealthCare, Boston, MA, United States.'}, {'ForeName': 'Joseph Andrew', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}]",JMIR research protocols,['10.2196/resprot.6198']
924,32413581,Trauma-related cognitions predict treatment response in smokers with PTSD: Evidence from cross-lagged panel analyses.,"OBJECTIVE


Compared to smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke more heavily and are less successful in quitting smoking. However, limited research has examined the cognitive pathways underlying this heightened comorbidity. The current study is the first to simultaneously model the cross-sectional and lagged relationships between trauma-related cognitions and cigarette smoking, as well as between trauma-related cognitions and PTSD severity, in smokers with comorbid PTSD receiving treatment.
METHOD


Participants (n = 142) were seeking treatment for smoking cessation and PTSD as part of a randomized controlled trial of varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline + PE vs. varenicline only) (Foa et al., 2017). Data were available for both baseline and end-of-treatment assessments of trauma cognitions severity of cigarette smoking and PTSD symptoms. We conducted both cross-sectional and lagged analysis to simultaneously examine the bidirectional relationship from trauma cognitions and 1) cigarette smoking and 2) PTSD symptoms.
RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only. However, baseline trauma cognitions did not predict post-treatment cigarettes/day. Baseline trauma cognitions (specifically negative beliefs about the self and world) were associated with PTSD severity at both baseline and end of treatment; furthermore, these negative cognitions at baseline positively and prospectively predicted end-of-treatment PTSD severity, but not vice versa. Wald tests revealed that there were no treatment effects on these cross-lagged relationships. Conclusions These findings provide novel empirical support for the importance of addressing trauma-related cognitions in the smoking cessation treatment efforts for patients with comorbid PTSD and cigarette smoking.",2020,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","['smokers with PTSD', 'patients with comorbid PTSD and cigarette smoking', 'smokers without posttraumatic stress disorders (PTSD), smokers with PTSD smoke', 'Participants (n\u202f=\u202f142) were', 'smokers with comorbid PTSD receiving treatment']","['varenicline and smoking cessation counseling with or without adjunctive Prolonged Exposure (varenicline\u202f+\u202fPE vs. varenicline only', 'varenicline', 'seeking treatment for smoking cessation and PTSD']","['Baseline trauma cognitions', 'baseline trauma cognitions', 'PTSD severity', 'trauma cognitions severity of cigarette smoking and PTSD symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",142.0,0.00981447,"RESULTS


Trauma cognitions (specifically, negative beliefs about the self and the world) were significantly associated with cigarette/day at the end of treatment for participants who received varenicline only.","[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: wenting.mu@pennmedicine.upenn.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Narine', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology, Rutgers University, The State University of New Jersey, United States.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Lieblich', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Bredemeier', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106376']
925,31568390,Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients: A Randomized Controlled Trial.,"BACKGROUND


New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven.
METHODS


We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints.
RESULTS


Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, -446; 95% confidence interval [CI], -3184 to 2292; P = 0.748), insulin sensitivity (mean difference, -0.45; 95% CI, -1.34 to 0.44; P = 0.319), or disposition index (mean difference, -940; 95% CI, -5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, -1.537 kg; 95% CI, -2.947 to -0.127; P = 0.033), and improvement in weight (mean difference, -2.47 kg; 95% CI, -4.01 to -0.92; P = 0.002). No serious adverse events were noted.
CONCLUSIONS


Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.",2020,Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446,"['130 nondiabetic kidney transplant recipients with stable function between 3-24 months post transplantation', 'Between August 17 2015 and December 18 2017, 130 individuals were recruited of whom 103 completed the study (drop-out rate 20.8', 'kidney allograft recipients (CAVIAR']","['active versus passive lifestyle intervention', 'active intervention (lifestyle advice delivered by renal dietitians using behaviour change techniques) versus passive intervention (leaflet advice alone']","['insulin sensitivity', 'six-month change in insulin secretion, insulin sensitivity and disposition index', 'reduced incidence of post transplantation diabetes', 'patient-reported outcomes, cardio-metabolic parameters, clinical outcomes and safety endpoints', 'disposition index', 'surrogate markers of glucose metabolism', 'glucose metabolism; insulin secretion', 'reduction in fat mass', 'weight', 'serious adverse events']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C2347573', 'cui_str': 'Caviar (substance)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0586938', 'cui_str': 'Renal dietitian (occupation)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086589', 'cui_str': 'Surrogate Markers'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",130.0,0.460737,Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446,"[{'ForeName': 'Kulli', 'Initials': 'K', 'LastName': 'Kuningas', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Driscoll', 'Affiliation': 'Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mair', 'Affiliation': 'Department of Nutrition and Dietetics, Queen Elizabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Smith', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dutton', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'And Adnan', 'Initials': 'AA', 'LastName': 'Sharif', 'Affiliation': 'Department of Nephrology and Transplantation, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom.'}]",Transplantation,['10.1097/TP.0000000000002969']
926,31126960,"Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study).","PURPOSE


Limited options exist for patients with advanced pancreatic cancer progressing after 1 or more lines of therapy. A phase II study in patients with previously treated metastatic pancreatic cancer showed that combining GVAX pancreas (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated  Listeria monocytogenes  expressing mesothelin) resulted in median overall survival (OS) of 6.1 months, which compares favorably with historical OS achieved with chemotherapy. In the current study, we compared Cy/GVAX + CRS-207, CRS-207 alone, and standard chemotherapy in a three-arm, randomized, controlled phase IIb trial.
PATIENTS AND METHODS


Patients with previously treated metastatic pancreatic adenocarcinoma were randomized 1:1:1 to receive Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy (arm C). The primary cohort included patients who had failed ≥2 prior lines of therapy, including gemcitabine. The primary objective compared OS between arms A and C in the primary cohort. The second-line cohort included patients who had received 1 prior line of therapy. Additional objectives included OS between all treatment arms, safety, and tumor responses.
RESULTS


The study did not meet its primary efficacy endpoint. At the final study analysis, median OS [95% confidence interval (CI)] in the primary cohort ( N  = 213) was 3.7 (2.9-5.3), 5.4 (4.2-6.4), and 4.6 (4.2-5.7) months in arms A, B, and C, respectively, showing no significant difference between arm A and arm C [ P  = not significant (NS), HR = 1.17; 95% CI, 0.84-1.64]. The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea. No treatment-related deaths occurred.
CONCLUSIONS


The combination of Cy/GVAX + CRS-207 did not improve survival over chemotherapy. (ClinicalTrials.gov ID: NCT02004262) See related commentary by Salas-Benito et al., p. 5435 .",2019,"The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea.","['patients with advanced pancreatic cancer progressing after 1 or more lines of therapy', 'patients who had failed ≥2 prior lines of therapy, including', 'patients who had received 1 prior line of therapy', 'Patients and Methods:  Patients with previously treated metastatic pancreatic adenocarcinoma', 'patients with previously treated metastatic pancreatic cancer', 'Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study']","['gemcitabine', 'cyclophosphamide (Cy) and CRS-207', 'Chemotherapy', 'GVAX Pancreas and CRS-207', 'Cy/GVAX + CRS-207', 'Cy/GVAX + CRS-207, CRS-207 alone, and standard chemotherapy', ""Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy""]","['survival', 'median overall survival (OS', 'adverse events', 'median OS', 'chills, pyrexia, fatigue, and nausea', 'safety, and tumor responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",,0.202644,"The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea.","[{'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland. dle@jhmi.edu.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kindler', 'Affiliation': 'University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang-Gillam', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oberstein', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Morse', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Weekes', 'Affiliation': 'University of Colorado Cancer Center, Aurora, Colorado.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Reid', 'Affiliation': 'University of San Diego Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Erkut', 'Initials': 'E', 'LastName': 'Borazanci', 'Affiliation': 'HonorHealth, Tgen, Scottsdale, Arizona.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Crocenzi', 'Affiliation': 'Providence Cancer Center, Portland, Oregon.'}, {'ForeName': 'Noelle K', 'Initials': 'NK', 'LastName': 'LoConte', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Musher', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Laheru', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Murphy', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Whiting', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Enstrom', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Ferber', 'Affiliation': 'Array Biostatistics, LLC, Chicago, Illinois.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Brockstedt', 'Affiliation': 'Aduro Biotech, Berkeley, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2992']
927,26500320,Promoting physical activity in older people in general practice: ProAct65+ cluster randomised controlled trial.,"BACKGROUND


Regular physical activity reduces falls, hip fractures, and all-cause mortality, but physical activity levels are low in older age groups.
AIM


To evaluate two exercise programmes promoting physical activity among older people.
DESIGN AND SETTING


Pragmatic three-arm, parallel-design cluster randomised controlled trial involving 1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby.
METHOD


Practices were randomised to the class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care. The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention. Secondary outcomes included falls, quality of life, balance confidence, and costs.
RESULTS


In total, 49% of FaME participants reached the physical activity target compared with 38% for usual care (adjusted odds ratio 1.78, 95% confidence interval [CI] =1.11 to 2.87, P = 0.02). Differences between FaME and usual care persisted 24 months after intervention. There was no significant difference comparing those in the OEP (43% reaching target at 12 months) and usual-care arms. Participants in the FaME arm added around 15 minutes of moderate-to-vigorous physical activity per day to their baseline level; this group also had a significantly lower rate of falls (incident rate ratio 0.74, 95% CI = 0.55 to 0.99, P = 0.042). Balance confidence was significantly improved in both intervention arms. The mean cost per extra person achieving the physical activity target was £1740. Attrition and rates of adverse reactions were similar.
CONCLUSION


The FaME programme increases self-reported physical activity for at least 12 months post-intervention and reduces falls in people aged ≥65 years, but uptake is low. There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.",2015,"There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.","['1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby', 'older people in general practice', 'older people']","['class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care', 'exercise programmes']","['proportion reaching the recommended physical activity', 'rate of falls', 'physical activity target', 'falls, quality of life, balance confidence, and costs', 'Attrition and rates of adverse reactions', 'Balance confidence', 'mean cost per extra person achieving the physical activity target', 'OEP']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",1256.0,0.111544,"There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Iliffe', 'Affiliation': 'University College London, London.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'University of Nottingham, Nottingham.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morris', 'Affiliation': 'University of Bristol, Bristol.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'University College London, London.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Haworth', 'Affiliation': 'University College London, London.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Carpenter', 'Affiliation': 'University of Nottingham, Nottingham.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Masud', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Dinan-Young', 'Affiliation': 'University College London, London.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bowling', 'Affiliation': 'University of Southampton.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp15X687361']
928,32418770,Comment on: Severe obesity and vitamin D deficiency treatment options before the bariatric surgery: a randomized clinical trial.,,2020,,[],[],[],[],[],[],,0.0865464,,"[{'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Furtado', 'Affiliation': 'Department of Bariatric Surgery, University of Maryland Medical Center, Baltimore, Maryland.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.04.004']
929,32417102,"Corrigendum to ""Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes - A randomized controlled trial"" [Contemporary Clinical Trials 89 (2020) 105933].",,2020,,[],[],[],[],[],[],,0.05593,,"[{'ForeName': 'Minal R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America. Electronic address: minalrp@umich.edu.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; Department of Internal Medicine, Michigan Medicine, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Piette', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America; U.S. Department of Veterans Affairs VA, Ann Arbor Healthcare System, United States of America.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Hae Mi', 'Initials': 'HM', 'LastName': 'Choe', 'Affiliation': 'College of Pharmacy, University of Michigan, United States of America; University of Michigan Medical Group, United States of America.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Tobi', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior & Health Education, University of Michigan School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106025']
930,31898309,Technology-Based Psychosocial Intervention to Improve Quality of Life and Reduce Symptom Burden in Men with Advanced Prostate Cancer: Results from a Randomized Controlled Trial.,"BACKGROUND


Men with advanced prostate cancer (APC) face multiple challenges including poor prognosis, poor health-related quality of life (HRQOL), and elevated symptom burden. This study sought to establish the efficacy of a tablet-delivered, group-based psychosocial intervention for improving HRQOL and reducing symptom burden in men with APC. We hypothesized that men randomized to cognitive-behavioral stress management (CBSM) would report improved HRQOL and reduced symptom burden relative to men randomized to an active control health promotion (HP) condition. Condition effects on intervention targets and moderators of these effects were explored.
METHODS


Men with APC (N = 192) were randomized (1:1) to 10-week tablet-delivered CBSM or HP, and followed for 1 year. Multilevel modeling was used to evaluate condition effects over time.
RESULTS


Changes in HRQOL and symptom burden did not differ between groups. Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time. Moderating factors included baseline interpersonal disruption, fatigue, and sexual functioning.
CONCLUSIONS


Tablet-delivered CBSM and HP were well received by men with APC. The hypothesized effects of CBSM on HRQOL and symptom burden were not supported, though improvements in intervention targets were observed across conditions. Participants reported high-baseline HRQOL relative to cancer and general population norms, possibly limiting intervention effects. The identified moderating factors should be considered in the development and implementation of interventions targeting HRQOL and symptom burden.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03149185.",2020,"Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time.","['men with APC', 'Men with APC (N\u2009=\u2009192', 'Men with advanced prostate cancer (APC', 'Men with Advanced Prostate Cancer']","['CBSM', 'cognitive-behavioral stress management (CBSM', 'CBSM or HP', 'tablet-delivered, group-based psychosocial intervention', 'Technology-Based Psychosocial Intervention']","['HRQOL and symptom burden', 'baseline interpersonal disruption, fatigue, and sexual functioning', 'Quality of Life', 'cancer-related anxiety, cancer-related distress, and feelings of cohesiveness']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.300426,"Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time.","[{'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Penedo', 'Affiliation': 'Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA. frank.penedo@miami.edu.'}, {'ForeName': 'Rina S', 'Initials': 'RS', 'LastName': 'Fox', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Oswald', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Moreno', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Cody L', 'Initials': 'CL', 'LastName': 'Boland', 'Affiliation': 'Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA.'}, {'ForeName': 'Ryne', 'Initials': 'R', 'LastName': 'Estabrook', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'McGinty', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Begale', 'Affiliation': 'Vibrent Health, Fairfax, VA, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Dahn', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Miami Veterans Affairs Healthcare System, Miami, FL, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Flury', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Kent T', 'Initials': 'KT', 'LastName': 'Perry', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Shilajit D', 'Initials': 'SD', 'LastName': 'Kundu', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09839-7']
931,27375381,"Controlled hypotension in day care functional endoscopic sinus surgery: A comparison between esmolol and dexmedetomidine: A prospective, double-blind, and randomized study.","BACKGROUND


Functional endoscopic sinus surgery (FESS) is the cornerstone of therapeutic management for nasal pathologies. This study is to compare the ability of preoperative and intraoperative esmolol versus dexmedetomidine for producing induced hypotension during FESS in adults in a day care setting.
MATERIALS AND METHODS


Sixty patients (20-45 years) posted for FESS under general anesthesia were randomly divided into Group E (n = 30) receiving esmolol, loading dose 1 mg/kg over 1 min followed by 0.5 mg/kg/h infusion during maintenance and Group D (n = 30) receiving dexmedetomidine 1 μg/kg over 15 min before induction of anesthesia followed by 0.5 μg/Kg/h infusion during maintenance, respectively. Nasal bleeding and Surgeon's satisfaction score; amount and number of patients receiving fentanyl and nitroglycerine for analgesia and deliberate hypotension, Postanesthesia Care Unit (PACU) and hospital stay; hemodynamic parameters and side effects were recorded for each patient.
RESULTS


Significantly less number and dosage of nitroglycerine was required (P = 0.0032 and 0.0001, respectively) in Group D compared to that in Group E. Again the number and dosage of patients requiring fentanyl were significantly lower in Group D. However, the duration of controlled hypotension was almost similar in both the groups. Group D patients suffered from significantly less nasal bleeding, and surgeon's satisfaction score was also high in this group. Discharge from PACU and hospital were significantly earlier in Group D. Intraoperative hemodynamics were quite comparable (P > 0.05) without any appreciable side effects.
CONCLUSION


Dexmedetomidine found to be providing more effectively controlled hypotension and analgesia and thus allowing less nasal bleeding as well as more surgeons' satisfaction score.",2016,"Significantly less number and dosage of nitroglycerine was required (P = 0.0032 and 0.0001, respectively) in Group D compared to that in Group E. Again the number and dosage of patients requiring fentanyl were significantly lower in Group D.","['Sixty patients (20-45 years) posted for FESS under general anesthesia', 'day care functional endoscopic sinus surgery', 'adults in a day care setting']","['esmolol', 'fentanyl and nitroglycerine', 'Dexmedetomidine', 'Controlled hypotension', 'esmolol and dexmedetomidine', 'esmolol, loading dose 1 mg/kg over 1 min followed by 0.5 mg/kg/h infusion during maintenance and Group D', 'Functional endoscopic sinus surgery (FESS', 'dexmedetomidine']","[""nasal bleeding, and surgeon's satisfaction score"", 'analgesia and deliberate hypotension, Postanesthesia Care Unit (PACU) and hospital stay; hemodynamic parameters and side effects', 'nasal bleeding', ""Nasal bleeding and Surgeon's satisfaction score"", 'number and dosage of nitroglycerine', 'duration of controlled hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}]","[{'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}]",60.0,0.0389788,"Significantly less number and dosage of nitroglycerine was required (P = 0.0032 and 0.0001, respectively) in Group D compared to that in Group E. Again the number and dosage of patients requiring fentanyl were significantly lower in Group D.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chhaule', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Basunia', 'Affiliation': 'Department of Anesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Halder', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.174919']
932,32419349,Prophylactic Foley catheter insertion into defunctioning ileostomy to reduce obstruction after colorectal surgery: pilot randomized controlled trial.,"BACKGROUND


Defunctioning ileostomies provide faecal diversion in major colorectal surgery. This reduces the consequences of an anastomotic leak. However, the formation of an ileostomy carries risks including obstruction at the level of the fascia. Post-operative oedema at the level of the fascia may contribute to obstruction. We hypothesize that the prophylactic insertion of a Foley catheter into the afferent limb of a defunctioning loop ileostomy may help decompress and improve time to low-residue diet (LRD). The objective of the study was to assess the feasibility of a Foley catheter, prophylactically inserted into the afferent limb of a defunctioning loop ileostomy, after major colorectal surgery.
METHODS


The study was a prospective pilot-randomized controlled trial. Ethical approval was obtained from Northern B Health and Disability Ethics Committee 15/NTB/91 ANZCTR Trial ID: ACTRN12615000691549.
RESULTS


Forty-nine patients undergoing major elective colorectal surgery with a defunctioning ileostomy, between the years of 2015 and 2018 at North Shore Hospital, Auckland, New Zealand were included in this study. Patients were randomly allocated to either the Foley catheter (n = 26) or non-Foley catheter (n = 23) group. The median time taken to tolerate LRD the primary outcome, was 2 days in the Foley group versus 2 days in the non-Foley group (P = 0.05). There were no differences in the secondary outcome measures such as time to stoma output, length of stay or complications.
CONCLUSION


This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group. There was no difference in length of stay, time to flatus or stoma output.",2020,This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group.,"['major colorectal surgery', 'Forty-nine patients undergoing major elective colorectal surgery with a defunctioning ileostomy, between the years of 2015 and 2018 at North Shore Hospital, Auckland, New Zealand were included in this study']","['Foley catheter, prophylactically inserted into the afferent limb of a defunctioning loop ileostomy', 'Prophylactic Foley catheter insertion into defunctioning ileostomy', 'Foley catheter (n =\u200926) or non-Foley catheter']","['time to stoma output, length of stay or complications', 'median time taken to tolerate LRD', 'length of stay, time to flatus or stoma output']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0023985', 'cui_str': 'Creation of continent ileostomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",49.0,0.195566,This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group.,"[{'ForeName': 'Suheelan', 'Initials': 'S', 'LastName': 'Kulasegaran', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Nisbet', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Vasey', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Bacil', 'Initials': 'B', 'LastName': 'Otutaha', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Planning, Funding and Outcomes, Waitemata and Auckland District Health Boards, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Mike H', 'Initials': 'MH', 'LastName': 'Moir', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}]",ANZ journal of surgery,['10.1111/ans.15714']
933,32418659,Extracorporeal Shockwave Therapy and Knee Osteoarthritis: Defining a Placebo Group.,,2020,,['and Knee Osteoarthritis'],"['Extracorporeal Shockwave Therapy', 'Placebo']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.018528,,"[{'ForeName': 'Goksel', 'Initials': 'G', 'LastName': 'Tanigor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Hepguler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.018']
934,26955303,"Pain relief after ambulatory hand surgery: A comparison between dexmedetomidine and clonidine as adjuvant in axillary brachial plexus block: A prospective, double-blinded, randomized controlled study.","BACKGROUND


For ages various adjuvants have been tried to prolong axillary brachial plexus block. We compared the effect of adding dexmedetomidine versus clonidine to ropivacaine for axillary brachial plexus blockade. The primary endpoints were the onset and duration of sensory and motor block and duration of analgesia.
MATERIALS AND METHODS


A total of 90 patients (20-40 years) posted for ambulatory elective hand surgery under axillary brachial plexus block were divided into two equal groups (groups ropivacaine dexmedetomidine [RD] and ropivacaine clonidine [RC]) in a randomized, double-blind fashion. In group RD (n = 45) 30 ml 0.5% ropivacaine + 100 μg of dexmedetomidine and group RC (n = 45) 30 ml 0.5% ropivacaine + 75 μg clonidine were administered in axillary plexus block. Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics and side-effects were recorded for each patient.
RESULTS


Though with similar demographic profile in both groups, sensory and motor block in group RD (P < 0.05) was earlier than group RC. Sensory and motor block duration and time to first analgesic use were significantly longer and the total need for rescue analgesics was lower in group RD (P < 0.05) than group RC. Postoperative VAS value at 18 h were significantly lower in group RD (P < 0.05). Intraoperative hemodynamics were insignificantly lower in group RD (P < 0.05) without any appreciable side-effects.
CONCLUSION


It can be concluded that adding dexmedetomidine to axillary plexus block increases the sensory and motor block duration and time to first analgesic use, and decreases total analgesic use with no side-effects.",2016,"Intraoperative hemodynamics were insignificantly lower in group RD (P < 0.05) without any appreciable side-effects.
","['axillary brachial plexus blockade', '90 patients (20-40 years) posted for ambulatory elective hand surgery under axillary brachial plexus block', 'axillary brachial plexus block']","['dexmedetomidine and clonidine', 'clonidine', 'ambulatory hand surgery', 'ropivacaine dexmedetomidine [RD', 'ropivacaine', 'ropivacaine clonidine [RC', 'dexmedetomidine']","['Pain relief', 'Postoperative VAS value', 'Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics and side-effects', 'onset and duration of sensory and motor block and duration of analgesia', 'Intraoperative hemodynamics', 'Sensory and motor block duration and time to first analgesic use', 'total need for rescue analgesics', 'sensory and motor block']","[{'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0394701', 'cui_str': 'Brachial plexus block by axillary approach (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}]",90.0,0.0840651,"Intraoperative hemodynamics were insignificantly lower in group RD (P < 0.05) without any appreciable side-effects.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R. G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chhaule', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Banu', 'Affiliation': 'Department of G and O, Berhampore, West Bengal, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mandal', 'Affiliation': 'Department of G and O, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chandra', 'Affiliation': 'Department of Orthopedics, R. G. Kar Medical College, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169443']
935,28166849,Assessing Patient Progress in Psychological Therapy Through Feedback in Supervision: the MeMOS* Randomized Controlled Trial (*Measuring and Monitoring clinical Outcomes in Supervision: MeMOS).,"BACKGROUND


Psychological therapy services are often required to demonstrate their effectiveness and are implementing systematic monitoring of patient progress. A system for measuring patient progress might usefully 'inform supervision' and help patients who are not progressing in therapy.
AIMS


To examine if continuous monitoring of patient progress through the supervision process was more effective in improving patient outcomes compared with giving feedback to therapists alone in routine NHS psychological therapy.
METHOD


Using a stepped wedge randomized controlled design, continuous feedback on patient progress during therapy was given either to the therapist and supervisor to be discussed in clinical supervison (MeMOS condition) or only given to the therapist (S-Sup condition). If a patient failed to progress in the MeMOS condition, an alert was triggered and sent to both the therapist and supervisor. Outcome measures were completed at beginning of therapy, end of therapy and at 6-month follow-up and session-by-session ratings.
RESULTS


No differences in clinical outcomes of patients were found between MeMOS and S-Sup conditions. Patients in the MeMOS condition were rated as improving less, and more ill. They received fewer therapy sessions.
CONCLUSIONS


Most patients failed to improve in therapy at some point. Patients' recovery was not affected by feeding back outcomes into the supervision process. Therapists rated patients in the S-Sup condition as improving more and being less ill than patients in MeMOS. Those patients in MeMOS had more complex problems.",2017,No differences in clinical outcomes of patients were found between MeMOS and S-Sup conditions.,[],[],['complex problems'],[],[],"[{'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",,0.0293534,No differences in clinical outcomes of patients were found between MeMOS and S-Sup conditions.,"[{'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Davidson', 'Affiliation': 'Institute of Health and Wellbeing,University of Glasgow.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Rankin', 'Affiliation': 'Institute of Health and Wellbeing,University of Glasgow.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Begley', 'Affiliation': 'Institute of Health and Wellbeing,University of Glasgow.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lloyd', 'Affiliation': 'Robertson Centre for Biostatistics,Institute of Health and Wellbeing,University of Glasgow.'}, {'ForeName': 'Sarah J E', 'Initials': 'SJ', 'LastName': 'Barry', 'Affiliation': 'Robertson Centre for Biostatistics,Institute of Health and Wellbeing,University of Glasgow.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McSkimming', 'Affiliation': 'Robertson Centre for Biostatistics,Institute of Health and Wellbeing,University of Glasgow.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Institute of Health and Wellbeing,University of Glasgow.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Allan', 'Affiliation': 'NHS Greater Glasgow and Clyde.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Osborne', 'Affiliation': 'NHS Greater Glasgow and Clyde.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ralston', 'Affiliation': 'NHS Greater Glasgow and Clyde.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Bienkowski', 'Affiliation': 'NHS Education for Scotland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mellor-Clark', 'Affiliation': 'Centre for Community Mental Health,Birmingham City University.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Robertson Centre for Biostatistics,Institute of Health and Wellbeing,University of Glasgow.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465817000029']
936,32412960,Omega-3 fatty acid therapy for cardiovascular disease: justified or not?,"PURPOSE OF REVIEW


To discuss the current evidence regarding the relationship between omega-3 fatty acid intake and atherosclerotic cardiovascular disease (ASCVD) risk.
RECENT FINDINGS


Combined results from randomized controlled trials using low-dosage (≤1.8 g/day of ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA) suggest a small benefit for reducing coronary heart disease risk. The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality. Several national organizations have recommended IPE for ASCVD risk reduction in populations aligning with REDUCE-IT; the Food and Drug Administration has approved IPE for ASCVD risk reduction. However, the Outcomes Study to Assess Statin Residual Risk Reduction with Epanova (EPA + DHA carboxylic acids) in High Cardiovascular Risk Patients with Hypertriglyceridemia was recently stopped for futility.
SUMMARY


At present, the best available evidence for a role of omega-3 fatty acids in ASCVD risk reduction is for 4 g/day of IPE, as an adjunct to statin therapy, for patients with ASCVD or diabetes mellitus and elevated triglycerides.",2020,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","['High Cardiovascular Risk Patients with Hypertriglyceridemia', 'patients with ASCVD or diabetes mellitus and elevated triglycerides']","['ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA', 'Epanova (EPA + DHA carboxylic acids', 'omega-3 fatty acids', 'Omega-3 fatty acid therapy']","['Reduction of Cardiovascular Events', 'cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4026303', 'cui_str': 'Epanova'}, {'cui': 'C0007066', 'cui_str': 'Carboxylic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}]",,0.0504947,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}]",Current opinion in cardiology,['10.1097/HCO.0000000000000741']
937,31570123,An online mindfulness-based intervention for undergraduate pharmacy students: Results of a mixed-methods feasibility study.,"INTRODUCTION


Stress negatively impacts pharmacy students' physical and mental health. Mindfulness has been shown to improve student wellbeing. The purpose of this study was to assess the feasibility and acceptability of an online mindfulness-based intervention and determine its effect on student wellbeing.
METHODS


A quasi-randomised controlled trial was conducted at four pharmacy schools in Ireland. The intervention group took part in a four-week online mindfulness course. The control group received usual education, with delayed access to the course. Participants completed the Perceived Stress Scale, the General Health Questionnaire, the Jefferson Scale of Empathy - Health Profession Student version, the Maslach Burnout Inventory Student Survey (MBI-SS), and the Five Facet Mindfulness Questionnaire at baseline and post-intervention. Answers provided to questions about the experience of participating in the course were analysed using thematic analysis.
RESULTS


Of the 52 participants, no significant differences were found between the intervention and control groups at baseline. Post-intervention, an increase in professional efficacy, as measured by the MBI-SS, was found in the intervention group (p = 0.004). There was also an increase in observing scores (p = 0.003). Males showed greater improvements in stress (p = 0.04) and non-judgement (p = 0.03) levels. Only females demonstrated improvement in professional efficacy (p = 0.002). Participants self-reported stress reduction and increased awareness of emotions.
CONCLUSION


This study provides insights into the feasibility and acceptability of an online mindfulness course for pharmacy students. Findings will inform the future design and implementation of larger studies.",2019,Males showed greater improvements in stress (p = 0.04) and non-judgement (p = 0.03) levels.,"['pharmacy students', 'undergraduate pharmacy students', 'A quasi-randomised controlled trial was conducted at four pharmacy schools in Ireland', '52 participants']","['online mindfulness-based intervention', 'usual education']","['professional efficacy', 'Perceived Stress Scale, the General Health Questionnaire, the Jefferson Scale of Empathy - Health Profession Student version, the Maslach Burnout Inventory Student Survey (MBI-SS), and the Five Facet Mindfulness Questionnaire', 'stress', 'awareness of emotions', 'observing scores', 'feasibility and acceptability']","[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036381', 'cui_str': 'Schools, Pharmacy'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",52.0,0.0251241,Males showed greater improvements in stress (p = 0.04) and non-judgement (p = 0.03) levels.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': ""O'Driscoll"", 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: michelle.odriscoll@ucc.ie.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: Stephen.byrne@ucc.ie.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Byrne', 'Affiliation': 'Mindfulness Centre for Professional Training in Ireland, 33 Pembroke Street Lower, Dublin 2, Ireland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Lambert', 'Affiliation': 'School of Applied Psychology, University College Cork, Ireland. Electronic address: sharon.lambert@ucc.ie.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Sahm', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland; Pharmacy Department, Mercy University Hospital, Cork, Ireland. Electronic address: l.sahm@ucc.ie.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2019.05.013']
938,27719707,[Expression of secreted frizzled-related protein-1 in patient with oral submucous fibrosis].,"Objective:  To investigate the concentrations and clinical significance of secreted frizzled-related protein-1(SFRP1) insaliva and gingival crevicular fluid of patients with oral submucous fibrosis (OSF) as well as the expression of SFRP1 in patients' OSF buccal mucosa.  Methods:  Twenty OSF patients aged 20 to 40 years old were recruited and randomly divided into two experimental groups, of which were triamcinolone acetonide group and combined triamcinolone acetonide and salvia miltiorrhiza group, respectively. Ten healthy volunteers matchable in sex and age with the patients were recruited as control group. Concentrations of SFRP1 in saliva and gingival crevicular fluid were detected by enzyme-linked immunosorbent assay before and after a continuous treatment of 4 weeks. The visual analogue scale(VAS) pain scores and opening size were also recorded. The expression of SFRP1 in samples from OSF patients' buccal mucosa was also detected using immunohistochemical method. SPSS 16.0 was applied to analyze the results of the experiments.  Results:  The concentrations of SFRP1 in saliva and gingival crevicular fluid before treatment were (105.8±27.6) ng/L and (84.7±33.2) ng/L in triamcinolone acetonide group, and (86.6±23.2) ng/L and (97.0±23.2) ng/L in combining group, which were both significantly lower( P< 0.01) than that in normal group([153.0±32.8] ng/L and [157.5±31.1] ng/L), respectively. The positive expression rate of SFRP1 in OSF group(10%[2/20]) was significantly lower than that of the control group(10/10)( P< 0.01). After the treatment for 4 weeks, the concentrations of SFRP1 increased to (141.2±35.3) ng/L and (130.6±31.3) ng/L in triamcinolone acetonide group, and to (148.5±65.9) ng/L and (123.0±27.4) ng/L in combining group, which were both significantly higher than those of pre-treatment, respectively( P< 0.01).  Conclusions:  The concentrations of SFRP1 in saliva and gingival crevicular fluid of OSF patients, which positively corelated to the expression of SFRP1 in OSF patients' buccal mucosa, were significantly lower than that of normal individuals and increased significantly after treatments of local injections of triamcinolone acetonide only or combined with salvia miltiorrhiza.",2016,The positive expression rate of SFRP1 in OSF group(10%[2/20]) was significantly lower than that of the control group(10/10),"['patient with oral submucous fibrosis', 'Ten healthy volunteers matchable in sex and age with the patients were recruited as control group', ""patients' OSF buccal mucosa"", 'patients with oral submucous fibrosis (OSF', 'Twenty OSF patients aged 20 to 40 years old']","['triamcinolone acetonide group and combined triamcinolone acetonide and salvia miltiorrhiza', 'salvia miltiorrhiza', 'triamcinolone acetonide']","['Concentrations of SFRP1 in saliva and gingival crevicular fluid', 'concentrations of SFRP1 in saliva and gingival crevicular fluid', 'visual analogue scale(VAS) pain scores and opening size', 'concentrations of SFRP1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029172', 'cui_str': 'Oral Submucous Fibrosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1578559', 'cui_str': 'Intraoral surface of cheek'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0696940', 'cui_str': 'Dan-Shen'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",10.0,0.0290393,The positive expression rate of SFRP1 in OSF group(10%[2/20]) was significantly lower than that of the control group(10/10),"[{'ForeName': 'F Y', 'Initials': 'FY', 'LastName': 'Lyu', 'Affiliation': 'Department of Oral Medicine, Xiangya Hospital, Central South University, Changsha 410008, China (Pressent address: The State Key Laboratory Breeding Base of Basic Science of Stomatology & Key Laboratory of Oral Biomedicine Ministry of Education, School of Stomatology, Wuhan University, Wuhan 430079, China).'}, {'ForeName': 'H F', 'Initials': 'HF', 'LastName': 'Wang', 'Affiliation': 'Department of Oral Medicine, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Xu', 'Affiliation': 'Department of Oral Medicine, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology & Key Laboratory of Oral Biomedicine Ministry of Education, School of Stomatology, Wuhan University, Wuhan 430079, China.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Li', 'Affiliation': 'Department of Oral Medicine, Xiangya Hospital, Central South University, Changsha 410008, China.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Chi', 'Affiliation': 'Department of Oral Medicine, Xiangya Hospital, Central South University, Changsha 410008, China.'}]",Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology,['10.3760/cma.j.issn.1002-0098.2016.10.009']
939,27103548,Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.,"Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans.",2016,The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks.,"['veterans with chronic low back pain', 'US military veterans with CLBP', 'Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans', '144 US military veterans with CLBP']",[],"['disability and pain', 'change in back pain-related disability measured with the Roland-Morris Disability Questionnaire', 'pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",144.0,0.111984,The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks.,"[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA. Electronic address: egroessl@ucsd.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmalzl', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Maiya', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Goodman', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Family Medicine and Public Health, University of California San Diego, CA, USA.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Chang', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Orthopaedic Surgery, University of California San Diego, CA, USA.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Psychiatry, University of California San Diego, CA, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Bormann', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; School of Nursing, University of San Diego, CA, USA.'}, {'ForeName': 'J Hamp', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Psychiatry, University of California San Diego, CA, USA.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Baxi', 'Affiliation': 'VA San Diego Healthcare System, CA, USA; Department of Medicine, University of California San Diego, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2016.04.006']
940,27029704,"Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial.","BACKGROUND


In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2- endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups.
PATIENTS AND METHODS


Patients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1-4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0-100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model.
RESULTS


Questionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5-67.7 versus 63.0, 95% CI 60.6-65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (-3.3, 95% CI -5.1 to -1.5 versus 2.0, 95% CI -0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone.
CONCLUSION


Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression.
CLINICAL TRIAL REGISTRATION


NCT01942135.",2016,"Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone.
","['Patients were randomized 2 : 1 to receive', 'previously treated hormone receptor-positive, HER2-negative metastatic breast cancer']","['placebo plus fulvestrant', 'palbociclib', 'fulvestrant', 'palbociclib plus fulvestrant', 'fulvestrant plus placebo', 'Palbociclib plus fulvestrant']","['PROs', 'pain', 'global QoL and pain', 'functioning/quality of life (QoL) or worse symptom severity', 'overall global QoL scores', 'progression-free survival', 'Questionnaire completion rates', 'delayed deterioration in global QoL', 'QLQ-BR23 functioning domains, breast or arm symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.485977,"Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone.
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of Obstetrics and Gynecology, Brustzentrum der Universität München, München (LMU), Germany. Electronic address: nadia.harbeck@med.uni-muenchen.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Iyer', 'Affiliation': 'Pfizer Inc, New York, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Department of Molecular Oncology, Royal Marsden Hospital and Institute of Cancer Research, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University, Philadelphia, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ro', 'Affiliation': 'Department of Medicine, National Cancer Center, Goyang-si, Korea.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Department of Oncology, Peter MacCallum Cancer Centre, East Melbourne, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Medicine, Sunnybrook Odette Cancer Centre, Toronto, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Transfusion, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bhattacharyya', 'Affiliation': 'Pfizer Inc, New York, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Puyana Theall', 'Affiliation': 'Pfizer Inc, Cambridge, USA.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer Inc, New York, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Department of Oncology, German Breast Group Forschungs GmbH, Neu-Isenburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw139']
941,26955315,"Induced hypotension in ambulatory functional endoscopic sinus surgery: A comparison between dexmedetomidine and clonidine as premedication. A prospective, double-blind, and randomized study.","BACKGROUND


Functional endoscopic sinus surgery (FESS) is the mainstay of a therapeutic technique for nasal pathologies. This study is to compare the ability of preoperative dexmedetomidine versus clonidine for producing controlled hypotensive anesthesia during FESS in adults in an ambulatory care setting.
MATERIALS AND METHODS


Sixty patients (25-50 years) posted for ambulatory FESS procedures under general anesthesia were randomly divided into Group C and D (n = 33 each) receiving dexmedetomidine 1 μg/kg and clonidine 1.5 μg/kg, respectively; both diluted in 100 ml saline solution 15 min before anesthetic induction. Nasal bleeding and surgeon's satisfaction score; amount and number of patients receiving fentanyl and nitroglycerine for analgesia and deliberate hypotension, duration of hypotension, post anesthesia care unit (PACU) and hospital stay; hemodynamic parameters and side effects were recorded for each patient.
RESULTS


Number and dosage of nitroglycerine used was significantly (P = 0.034 and 0.0001 respectively) lower in Group D compared to that in Group C. Similarly, number of patients requiring fentanyl and dosage of same was significantly lower in Group D. But, the duration of controlled hypotension was almost similar in both the groups. Group D patients suffered from significantly less nasal bleeding and surgeon's satisfaction score was also high in this group. Discharge from PACU was significantly earlier in Group D, but hospital discharge timing was quite comparable among two groups. Intraoperative hemodynamics was significantly lower in Group D (P < 0.05) without any appreciable side effects.
CONCLUSION


Dexmedetomidine found to be providing more effectively controlled hypotension and analgesia, and thus, allowing less nasal bleeding as well as more surgeons' satisfaction score.",2016,"RESULTS


Number and dosage of nitroglycerine used was significantly (P = 0.034 and 0.0001 respectively) lower in Group D compared to that in Group C. Similarly, number of patients requiring fentanyl and dosage of same was significantly lower in Group D.","['ambulatory functional endoscopic sinus surgery', 'Sixty patients (25-50 years) posted for ambulatory FESS procedures under general anesthesia', 'adults in an ambulatory care setting']","['fentanyl and nitroglycerine', 'Dexmedetomidine', 'clonidine', 'Functional endoscopic sinus surgery (FESS', 'dexmedetomidine 1 μg/kg and clonidine 1.5 μg/kg, respectively; both diluted in 100 ml saline solution', 'dexmedetomidine']","['hospital discharge timing', ""Nasal bleeding and surgeon's satisfaction score"", 'Intraoperative hemodynamics', 'nasal bleeding', ""nasal bleeding and surgeon's satisfaction score"", 'Induced hypotension', 'duration of controlled hypotension', 'analgesia and deliberate hypotension, duration of hypotension, post anesthesia care unit (PACU) and hospital stay; hemodynamic parameters and side effects']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0354612,"RESULTS


Number and dosage of nitroglycerine used was significantly (P = 0.034 and 0.0001 respectively) lower in Group D compared to that in Group C. Similarly, number of patients requiring fentanyl and dosage of same was significantly lower in Group D.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukherje', 'Affiliation': 'Department of Anaesthesiology, N.R.S Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chhaule', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Halder', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Basunia', 'Affiliation': 'Department of Anaesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.169480']
942,32418302,A pilot non-inferiority randomized controlled trial to assess automatic adjustments of insulin doses in adolescents with type 1 diabetes on multiple daily injections therapy.,"BACKGROUND


Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users.
METHODS


We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy. Participants wore a glucose sensor and underwent 11 days of daily dose adjustments in either arm. Algorithm adjustments were reviewed and approved by a physician. The last 7 days were examined for outcomes.
RESULTS


Twenty-one youths (age 13.3 [SD, 3.7] years; 13 females; HbA1c 8.6% [SD, 1.8]) were randomized to either group (LA [n = 10] or PA [n = 11]). The algorithm made 293 adjustments with a 92% acceptance rate from the camp physicians. In the last 7 days, the time in target glucose (3.9-10 mmol/L) in LA (39.5%, SD, 20.7) was similar to PA (38.4%, SD, 15.6) (P = .89). The number of hypoglycemic events per day in LA (0.3, IQR, [0.1-0.6]) was similar to PA (0.2, IQR, [0.0-0.4]) (P = .42). There was no incidence of severe hypoglycemia nor ketoacidosis.
CONCLUSIONS


In this pilot study, glycemic outcomes in the LA group were similar to the PA group. This algorithm has the potential to facilitate MDI therapy, and longer and larger studies are warranted.",2020,"There was no incidence of severe hypoglycemia nor ketoacidosis.
","['MDI therapy users', '21 youths (age 13.3 (SD, 3.7) years; 13 females; HbA1c 8.6% (SD, 1.8', 'Adolescents with Type 1 Diabetes on Multiple Daily Injections Therapy', 'children and adolescents on MDI therapy']","['basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA', 'Multiple daily injections (MDI) therapy']","['glycemic outcomes', 'time in target glucose', 'severe hypoglycemia nor ketoacidosis', 'number of hypoglycemic events']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",293.0,0.0480095,"There was no incidence of severe hypoglycemia nor ketoacidosis.
","[{'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'Department of Electrical and Computer Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Palisaitis', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'von Oettingen', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Krishnamoorthy', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}]",Pediatric diabetes,['10.1111/pedi.13052']
943,32492153,VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population.,"CONTEXT


It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting.
OBJECTIVE


The objective of this work is to determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.
DESIGN


VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25 871 adults, randomly assigned November 2011 to March 2014 and treated for 5.3 years (median).
SETTING


This is a nationwide study.
PARTICIPANTS


Men 50 years or older and women 55 years or older (mean age, 67.1 years) without cancer or cardiovascular disease at baseline participated in this study.
INTERVENTIONS


Interventions included vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2 × 2 factorial design.
MAIN OUTCOME MEASURES


Main outcome measures include 2 or more falls and falls resulting in a doctor or hospital visit.
RESULTS


Baseline serum total 25-hydroxyvitamin D (25[OH]D) level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with 2 or more falls were similar between active and placebo groups (9.8% vs 9.4%). Over 5 years, there were no differences in the proportion having 2 or more falls (odds ratio [OR] = 0.97; 95% CI, 0.90-1.05, P = .50), falls resulting in a doctor visit (OR = 1.03; 95% CI, 0.94-1.13, P = .46), or resulting in a hospital visit (OR = 1.04; 95% CI, 0.90-1.19, P = .61) between groups. Results did not differ between those with baseline 25(OH)D less than 50 vs 50 nmol/L or greater or other cut points.
CONCLUSION


Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.",2020,Results did not differ between those with baseline 25(OH)D,"['Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline', 'Nationwide study', '25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median', 'generally healthy adults']","['vitamin D3 vs. placebo', 'supplemental vitamin D3', 'VITamin D and OmegA-3 TriaL (VITAL', 'placebo-controlled RCT', 'VITamin D and OmegA-3 TriaL', 'Vitamin D3 (cholecalciferol; 2,000 IU/day', 'Vitamin D Supplements', 'and/or omega-3 fatty acids (1 g/day) or respective placebos', 'vitamin D supplementation', 'placebo']","['proportion having ≥2 falls', 'falls resulting in a doctor visit', 'Risk of Falls', 'Baseline serum total 25-hydroxyvitamin D [25(OH)D] level', 'fall risk', 'falls, falls resulting in a doctor or hospital visit']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",25871.0,0.702356,Results did not differ between those with baseline 25(OH)D,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Cawthon', 'Affiliation': 'California Pacific Medical Center, Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa311']
944,28110564,"Recruitment to the ""Breast-Activity and Healthy Eating After Diagnosis"" (B-AHEAD) Randomized Controlled Trial.","Excess weight at breast cancer diagnosis and weight gain during treatment are linked to increased breast cancer specific and all-cause mortality. The Breast-Activity and Healthy Eating After Diagnosis (B-AHEAD) trial tested 2 weight loss diet and exercise programmes versus a control receiving standard written advice during adjuvant treatment. This article identifies differences in characteristics between patients recruited from the main trial site to those of the whole population from that site during the recruitment period and identifies barriers to recruitment. A total of 409 patients with operable breast cancer were recruited within 12 weeks of surgery. We compared demographic and treatment factors between women recruited from the main trial coordinating site (n = 300) to the whole breast cancer population in the center (n = 532). Uptake at the coordinating site was 42%, comparable to treatment trials in the unit (47%). Women recruited were younger (55.9 vs 61.2 years, P < .001), more likely to live in least deprived postcode areas (41.7% vs 31.6%, P = .004), and more likely to have screen-detected cancers (55.3% vs 48.7%, P = .026) than the whole breast cancer population. The good uptake highlights the interest in lifestyle change around the time of diagnosis, a challenging time in the patient pathway, and shows that recruitment at this time is feasible. Barriers to uptake among older women and women with a lower socioeconomic status should be understood and overcome in order to improve recruitment to future lifestyle intervention programs.",2018,"Women recruited were younger (55.9 vs 61.2 years, P < .001), more likely to live in least deprived postcode areas (41.7% vs 31.6%, P = .004), and more likely to have screen-detected cancers (55.3% vs 48.7%, P = .026) than the whole breast cancer population.","['409 patients with operable breast cancer', 'older women and women with a lower socioeconomic status', 'women recruited from the main trial coordinating site (n = 300) to the whole breast cancer population in the center (n = 532']",['weight loss diet and exercise programmes'],"['Excess weight at breast cancer diagnosis and weight gain', 'Breast-Activity and Healthy Eating']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0012167', 'cui_str': 'Weight Reduction Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",409.0,0.0395579,"Women recruited were younger (55.9 vs 61.2 years, P < .001), more likely to live in least deprived postcode areas (41.7% vs 31.6%, P = .004), and more likely to have screen-detected cancers (55.3% vs 48.7%, P = .026) than the whole breast cancer population.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pegington', 'Affiliation': '1 University Hospital of South Manchester, Manchester, UK.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Adams', 'Affiliation': '2 University of Manchester, Manchester, UK.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Bundred', 'Affiliation': '1 University Hospital of South Manchester, Manchester, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Campbell', 'Affiliation': '4 Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': '1 University Hospital of South Manchester, Manchester, UK.'}, {'ForeName': 'Sacha J', 'Initials': 'SJ', 'LastName': 'Howell', 'Affiliation': '2 University of Manchester, Manchester, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Speed', 'Affiliation': '2 University of Manchester, Manchester, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': '6 University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Harvie', 'Affiliation': '1 University Hospital of South Manchester, Manchester, UK.'}]",Integrative cancer therapies,['10.1177/1534735416687850']
945,32414547,Efficacy of botulinum toxin for treating a gummy smile.,"INTRODUCTION


This study was conducted to investigate the efficacy of botulinum toxin applied to the different muscles of patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value.
METHODS


Twenty-eight patients who had a gummy smile of more than 2 mm were randomly divided into 2 groups. Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2. Photographs were taken, and measurements were taken before injection and at 3 days, 15 days, 1 month, 4 months, 5 months, and 6 months after injection. The visual analogue scale was used to assess the level of satisfaction.
RESULTS


The average amount of visible gingiva in group 1 was 4.92 mm at the beginning of the treatment and 1.92 mm on the 15th day. In group 2, the average amount of visible gingiva was 4.58 mm at the beginning of treatment and 2.16 mm on the 15th day. In both treatment groups, it was determined that the measurements on the sixth month did not return to their initial values. The decrease in gingival appearances in group 1 was greater than in group 2. There was no significant difference between the groups in terms of return to baseline gingival exposure value. In both groups, it was seen that the increase in satisfaction in patients was high.
CONCLUSIONS


For gummy smile correction, botulinum toxin injection is thought to be an alternative method because it is effective and conservative and has high patient satisfaction.",2020,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"['patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value', 'Twenty-eight patients who had a gummy smile of more than 2\xa0mm']","['botulinum toxin', 'Botulinum toxin', 'botulinum toxin injection']","['visual analogue scale', 'satisfaction', 'average amount of visible gingiva', 'gingival appearances', 'return to baseline gingival exposure value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C3696916', 'cui_str': 'Gummy smile'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0146754,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"[{'ForeName': 'Ahmet Fatih', 'Initials': 'AF', 'LastName': 'Cengiz', 'Affiliation': 'Private Practice, Mersin, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Goymen', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Gaziantep University, Gaziantep, Turkey. Electronic address: mervegoymen@gmail.com.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Akcali', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Gaziantep University, Gaziantep, Turkey.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.014']
946,32415664,Neuronal Biomarkers in Predicting Neurodevelopmental Outcome in Term Babies with Perinatal Asphyxia.,"OBJECTIVE


To assess whether serum levels of neuronal biomarkers (S100 calcium-binding protein B and Neuron specific enolase) correlate with the neurodevelopmental outcome of term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia.
METHODS


This randomized controlled trial was conducted in a tertiary care teaching hospital, south India. There were 162 term infants with moderate to severe hypoxic ischemic encephalopathy who were randomized into 2 groups (Group A and B). Neonates in Group A and B received normothermia and therapeutic hypothermia respectively. Serum levels of neuronal biomarkers were estimated at 0, 24 (±1) and 72 (±1) h after birth using sandwich ELISA in both groups. All neonates were carefully monitored till discharge. Infants who survived the neonatal period were followed up in the high risk clinic for 18 mo and neurodevelopmental assessment was done using Developmental Assessment Scale for Indian Infants (DASII). Neurodevelopmental outcomes between the two groups were compared using Chi square test and neuronal biomarker levels between the groups were compared using Mann Whitney test.
RESULTS


The baseline maternal and neonatal characteristics in both groups were comparable. There was statistically insignificant lesser mortality in therapeutic hypothermia group compared to normothermia group with Risk Ratio (RR): 0.82 (28.2% vs. 34.5%, 95% CI: 0.52-1.29, p = 0.38). Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo. There was no significant correlation between S100B and Neuron specific enolase levels and neurodevelopmental outcome.
CONCLUSIONS


Serum levels of neuronal biomarkers (S100B and Neuron specific enolase) do not correlate with the long term neurodevelopmental outcome among these infants.",2020,"Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo.","['162 term infants with moderate to severe hypoxic ischemic encephalopathy', 'Term Babies with Perinatal Asphyxia', 'term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia', 'tertiary care teaching hospital, south India']",[],"['Chi square test and neuronal biomarker levels', 'baseline maternal and neonatal characteristics', 'S100B and Neuron specific enolase levels and neurodevelopmental outcome', 'Neurodevelopmental outcomes', 'motor and mental scores', 'mortality', 'Serum levels of neuronal biomarkers']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0021201', 'cui_str': 'India'}]",[],"[{'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",162.0,0.0912209,"Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo.","[{'ForeName': 'R Christina', 'Initials': 'RC', 'LastName': 'Catherine', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'B Vishnu', 'Initials': 'BV', 'LastName': 'Bhat', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. drvishnubhat@yahoo.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Adhisivam', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Shruthi K', 'Initials': 'SK', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vickneshwaran', 'Initials': 'V', 'LastName': 'Vinayagam', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Palanivel', 'Initials': 'P', 'LastName': 'Chinnakali', 'Affiliation': 'Department of Preventive & Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03283-2']
947,31565758,Combining a UV photo intervention with self-affirmation or self-compassion exercises: implications for skin protection.,"The current study tested whether self-affirmation or self-compassion exercises, shown to increase message acceptance, could maximize the benefit of a UV photo intervention on skin protection cognitions. College women (N = 167) were randomly assigned to: (1) view a UV photo or Black and White (no-UV) photo of their face and (2) write a self-affirmation, self-compassion, or neutral essay. Participants who saw their UV photo reported healthier cognitions, including greater perceived vulnerability and intentions to protect skin. Within the self-compassion condition, participants who saw their UV photo were also more likely to take the sunscreen packets offered. However, neither self-affirmation nor self-compassion enhanced the effect of the UV photo. Within the UV condition, women who completed these exercises had similar (and occasionally less healthy) cognitions and behavior as those who wrote a neutral essay. The benefits of self-affirmation and self-compassion in conjunction with health messages may be limited to higher risk groups who experience more message defensiveness than the current sample.",2020,"The current study tested whether self-affirmation or self-compassion exercises, shown to increase message acceptance, could maximize the benefit of a UV photo intervention on skin protection cognitions.",['College women (N\u2009=\u2009167'],"['UV photo or Black and White (no-UV) photo of their face and (2) write a self-affirmation, self-compassion, or neutral essay', 'UV photo intervention with self-affirmation or self-compassion exercises', 'self-affirmation or self-compassion exercises']","['vulnerability and intentions to protect skin', 'skin protection cognitions', 'healthier cognitions']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}]","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0600647', 'cui_str': 'Essays'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0195548,"The current study tested whether self-affirmation or self-compassion exercises, shown to increase message acceptance, could maximize the benefit of a UV photo intervention on skin protection cognitions.","[{'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Hagerman', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA. mstock@gwu.edu.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}, {'ForeName': 'Janine B', 'Initials': 'JB', 'LastName': 'Beekman', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'Behavioral Research Program, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Butler', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00104-6']
948,32416434,The immediate effects of a shoulder brace on muscle activity and scapular kinematics in subjects with shoulder impingement syndrome and rounded shoulder posture: A randomized crossover design.,"BACKGROUND


Round shoulder posture (RSP) is one of the potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of the scapula. Evidence on how the characteristics of a shoulder brace affecting the degree of RSP, shoulder kinematics, and associated muscle activity during movements is limited.
RESEARCH QUESTION


The purposes of this study were (1) to compare the effects of a shoulder brace on clinical RSP measurements, muscle activities and scapular kinematics during arm movements in subjects with shoulder impingement syndrome (SIS) and RSP; and (2) to compare the effects of two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps on muscle activities and scapular kinematics during arm movements in subjects with SIS and RSP.
METHODS


Twenty-four participants (12 males; 12 females) with SIS and RSP were randomly assigned into 2 groups (comfortable then forced, and forced then comfortable) with 2 strap configurations in each tension condition. The pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA) were used to assess the degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography were used to record the scapular kinematics and muscle activity during arm movements.
RESULTS


All clinical measurements with the brace were significantly improved (p < 0.05). Under forced tension, muscle activities were higher with the diagonal configuration than with the parallel configuration in the lower trapezius (LT) (1.2-2.3% MVIC, p < 0.05) and serratus anterior (SA) (2.3% MVIC, p = 0.015). For upward rotation and posterior tilting of the scapula, the diagonal configuration was larger than the parallel configuration (1.5°, p = 0.038; 0.4°-0.5°, p < 0.05, respectively).
SIGNIFICANCE


Different characteristics of the straps of the shoulder brace could alter muscle activity and scapular kinematics at different angles during arm movement. Based on the clinical treatment preference, the application of a shoulder brace with a diagonal configuration and forced tension is suggested for SIS and RSP subjects.",2020,All clinical measurements with the brace were significantly improved (p < 0.05).,"['subjects with SIS and RSP.\nMETHODS\n\n\nTwenty-four participants (12 males; 12 females) with SIS and RSP', 'subjects with shoulder impingement syndrome (SIS) and RSP; and (2', 'subjects with shoulder impingement syndrome and rounded shoulder posture']","['Round shoulder posture (RSP', 'shoulder brace', 'two configurations (parallel and diagonal) and two tensions (comfortable and forced tension) of the brace straps']","['pectoralis minor index (PMI), acromial distance (AD) and shoulder angle (SA', 'Under forced tension, muscle activities', 'muscle activity and scapular kinematics', 'clinical RSP measurements, muscle activities and scapular kinematics', 'serratus anterior (SA) ']","[{'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0183631', 'cui_str': 'Strap'}]","[{'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C2717795', 'cui_str': 'Clinical Rounds'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",24.0,0.0621097,All clinical measurements with the brace were significantly improved (p < 0.05).,"[{'ForeName': 'Yuan-Chun', 'Initials': 'YC', 'LastName': 'Chiu', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Yung-Shen', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Sciences and Institute of Sports Equipment Technology, University of Taipei, Taiwan.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Shen', 'Affiliation': 'Department of Products, Taiwan Textile Research Institute, Taiwan.'}, {'ForeName': 'Tyng-Guey', 'Initials': 'TG', 'LastName': 'Wang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Jing-Lan', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: yangjinglan@gmail.com.'}, {'ForeName': 'Jiu-Jenq', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan; Division of Physical Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taiwan. Electronic address: jiujlin@ntu.edu.tw.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.028']
949,26978668,Anxiety sensitivity class membership moderates the effects of pre-quit reduction in anxiety sensitivity on quit-day tobacco craving.,"BACKGROUND


Although anxiety sensitivity has been primarily conceptualized as a dimensional latent construct, empirical evidence suggests that it also maintains a latent class structure, reflecting low-, moderate-, and high-risk underlying classes. The present study sought to explore whether these anxiety sensitivity classes moderated the relations between the degree of pre-quit reductions in anxiety sensitivity and the severity of nicotine withdrawal symptoms and craving experienced on quit-day.
METHODS


Participants included 195 adult smokers (47% female; Mage=39.4) participating in a larger ""anxiety sensitivity reduction-smoking cessation"" intervention trial.
RESULTS


Anxiety sensitivity class significantly moderated relations between pre-quit reduction in anxiety sensitivity and quit-day craving. Specifically, smokers within the anxiety sensitivity high-risk class, who also demonstrated lesser pre-quit reductions in anxiety sensitivity, experienced the highest levels of craving on quit-day.
CONCLUSIONS


These findings highlight the importance of 'high-risk' classes of anxiety sensitivity to better understand the experience of craving on quit day.",2016,"Specifically, smokers within the anxiety sensitivity high-risk class, who also demonstrated lesser pre-quit reductions in anxiety sensitivity, experienced the highest levels of craving on quit-day.
","['Participants included 195 adult smokers (47% female; Mage=39.4) participating in a larger ""anxiety sensitivity reduction-smoking cessation"" intervention trial']",[],"['anxiety sensitivity on quit-day tobacco craving', 'anxiety sensitivity and the severity of nicotine withdrawal symptoms and craving experienced on quit-day', 'anxiety sensitivity and quit-day craving']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",195.0,0.0333484,"Specifically, smokers within the anxiety sensitivity high-risk class, who also demonstrated lesser pre-quit reductions in anxiety sensitivity, experienced the highest levels of craving on quit-day.
","[{'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Bakhshaie', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX 77204, USA. Electronic address: JBakhshaie@uh.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX 77204, USA; Department of Behavioral Sciences, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'Langdon', 'Affiliation': ""National Center for PTSD, Women's Health Sciences Division, VA Boston Healthcare System, Boston, MA 02130, USA; Department of Psychiatry, Boston University School of Medicine, Boston, MA 02118, USA.""}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Departments of Preventive Medicine and Psychology, University of Southern California, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology & Institute for Mental Health Research, The University of Texas, Austin, TX 78712, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Allan', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL 32306, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2016.02.009']
950,32416690,Combined Analysis of Clinical Data on HGF Gene Therapy to Treat Critical Limb Ischemia in Japan.,"OBJECTIVE


The objective of this combined analysis of data from clinical trials in Japan, using naked plasmid DNA encoding hepatocyte growth factor (HGF), was to document the safety and efficacy of intramuscular HGF gene therapy in patients with critical limb ischemia (CLI).
METHODS


HGF gene transfer was performed in 22 patients with CLI in a single-center open trial at Osaka University; 39 patients in a randomized, placebo-controlled, multi-center phase III trial, 10 patients with Buerger's disease in a multi-center open trial; and 6 patients with CLI in a multi-center open trial using 2 or 3 intramuscular injections of naked HGF plasmid at 2 or 4 mg. Resting pain on a visual analogue scale (VAS) and wound healing as primary endpoints were evaluated at 12 weeks after the initial injection. Serious adverse events caused by gene transfer were detected in 7 out of 77 patients (9.09%). Only one patient experienced peripheral edema (1.30%), in contrast to those who had undergone treatment with VEGF. At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to the placebo group (P=0.020).
RESULTS


The long-term analysis revealed a sustained decrease in the size of ischemic ulcer in HGF gene therapy group. In addition, VAS score over 50 mm at baseline (total 27 patients) demonstrated a tendency (P=0.059), but not significant enough, to improve VAS score in HGF gene therapy as compared to the placebo group.
CONCLUSION


The findings indicated that intramuscular injection of naked HGF plasmid tended to improve the resting pain and significantly decreased the size of the ischemic ulcer in the patients with CLI who did not have any alternative therapy, such as endovascular treatment (EVT) or bypass graft surgery. An HGF gene therapy product, CollategeneTM, was recently launched with conditional and time-limited approval in Japan to treat ischemic ulcer in patients with CLI. Further clinical trials would provide new therapeutic options for patients with CLI.",2020,"At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to placebo group (P=0.020).","['Japan', '22 patients with CLI in a single-center open trial at Osaka University; 39 patients in a randomized', 'patients with critical limb ischemia (CLI', 'patients with CLI', ""10 patients with Buerger's disease in a multi-center open trial; and 6 patients with""]","['HGF Gene Therapy', 'CLI', 'intramuscular HGF gene therapy', 'naked HGF plasmid at 2 mg or 4 mg', 'placebo']","['VAS score', 'size of the ischemic ulcer', 'Resting pain on a visual analogue scale (VAS) and wound healing', 'VAS and ischemic ulcer size', 'resting pain', 'peripheral edema', 'size of ischemic ulcer']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0424470', 'cui_str': 'Undressed'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0265000', 'cui_str': 'Ulcer of artery'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}]",10.0,0.0252449,"At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to placebo group (P=0.020).","[{'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Morishita', 'Affiliation': 'Department of Clinical Gene Therapy, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Munehisa', 'Initials': 'M', 'LastName': 'Shimamura', 'Affiliation': 'Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takeya', 'Affiliation': 'Department of Geriatric Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Nakagami', 'Affiliation': 'Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Chujo', 'Affiliation': 'AnGes Inc., Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ishihama', 'Affiliation': 'AnGes Inc., Tokyo, Japan.'}, {'ForeName': 'Ei', 'Initials': 'E', 'LastName': 'Yamada', 'Affiliation': 'AnGes Inc., Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}]",Current gene therapy,['10.2174/1566523220666200516171447']
951,31559916,Does Discrimination Breed Mistrust? Examining the Role of Mediated and Non-Mediated Discrimination Experiences in Medical Mistrust.,"Medical mistrust is associated with a decreased likelihood of engaging in various health behaviors, including health utilization and preventive screening. Despite calls for research to address medical mistrust, few studies have explicitly delved into antecedents to medical mistrust. The current study a) examines the relationship between discrimination experiences and medical mistrust and b) experimentally tests the influence of mediated vicarious discrimination on reported levels of medical mistrust. Participants ( N  = 198) were randomly assigned to view news stories in one of four experimental conditions: no exposure, no discrimination control, implicit racial discrimination, and explicit racial discrimination. Results indicated prior personal and vicarious discrimination experiences were related to medical mistrust. Furthermore, exposure to mediated discrimination influenced medical mistrust in different ways for Black and White participants. Among Black participants, medical mistrust was significantly higher for those exposed to the implicit racial discrimination condition than the control condition. Marginal differences were found for White participants such that those exposed to both explicit and implicit racial discrimination conditions reported higher medical mistrust than those exposed to the control condition. Our findings are discussed in terms of the theoretical and practical implications for health communication scholars seeking to examine and influence health behaviors.",2019,"Among Black participants, medical mistrust was significantly higher for those exposed to the implicit racial discrimination condition than the control condition.",['Participants ( N  =\xa0198'],"['view news stories in one of four experimental conditions: no exposure, no discrimination control, implicit racial discrimination, and explicit racial discrimination']",[],[],"[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205905', 'cui_str': 'Racial Prejudice'}]",[],,0.0111156,"Among Black participants, medical mistrust was significantly higher for those exposed to the implicit racial discrimination condition than the control condition.","[{'ForeName': 'Lillie D', 'Initials': 'LD', 'LastName': 'Williamson', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Marisa A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Cabral A', 'Initials': 'CA', 'LastName': 'Bigman', 'Affiliation': 'Department of Communication, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1669742']
952,27002107,Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX.,"BACKGROUND


Cetuximab plus chemotherapy is a first-line treatment option in metastatic KRAS and NRAS wild-type colorectal cancer (CRC) patients. No data are currently available on continuing anti-epidermal growth factor receptor (EGFR) therapy beyond progression.
PATIENTS AND METHODS


We did this open-label, 1:1 randomized phase II trial at 25 hospitals in Italy to evaluate the efficacy of cetuximab plus 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) as second-line treatment of KRAS exon 2 wild-type metastatic CRC patients treated in first line with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) plus cetuximab. Patients received FOLFOX plus cetuximab (arm A) or FOLFOX (arm B). Primary end point was progression-free survival (PFS). Tumour tissues were assessed by next-generation sequencing (NGS). This report is the final analysis.
RESULTS


Between 1 February 2010 and 28 September 2014, 153 patients were randomized (74 in arm A and 79 in arm B). Median PFS was 6.4 [95% confidence interval (CI) 4.7-8.0] versus 4.5 months (95% CI 3.3-5.7); [hazard ratio (HR), 0.81; 95% CI 0.58-1.12; P = 0.19], respectively. NGS was performed in 117/153 (76.5%) cases; 66/117 patients (34 in arm A and 32 in arm B) had KRAS, NRAS, BRAF and PIK3CA wild-type tumours. For these patients, PFS was longer in the FOLFOX plus cetuximab arm [median 6.9 (95% CI 5.5-8.2) versus 5.3 months (95% CI 3.7-6.9); HR, 0.56 (95% CI 0.33-0.94); P = 0.025]. There was a trend in better overall survival: median 23.7 [(95% CI 19.4-28.0) versus 19.8 months (95% CI 14.9-24.7); HR, 0.57 (95% CI 0.32-1.02); P = 0.056].
CONCLUSIONS


Continuing cetuximab treatment in combination with chemotherapy is of potential therapeutic efficacy in molecularly selected patients and should be validated in randomized phase III trials.",2016,"There was a trend in better overall survival: median 23.7 [(95% CI 19.4-28.0) versus 19.8 months (95% CI 14.9-24.7); HR, 0.57 (95% CI 0.32-1.02); P = 0.056].
","['metastatic KRAS and NRAS wild-type colorectal cancer (CRC) patients', 'metastatic colorectal cancer (CAPRI-GOIM', 'Between 1 February 2010 and 28 September 2014, 153 patients were randomized (74 in arm A and 79 in arm B', 'KRAS exon 2 wild-type metastatic CRC patients treated in first line with']","['FOLFOX plus cetuximab versus FOLFOX', 'Cetuximab plus chemotherapy', 'FOLFOX plus cetuximab (arm A) or FOLFOX', '5-fluorouracil, folinic acid and irinotecan (FOLFIRI) plus cetuximab', 'cetuximab plus 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX', 'Cetuximab continuation']","['overall survival', 'Median PFS', 'PFS', 'NGS', 'progression-free survival (PFS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",153.0,0.129392,"There was a trend in better overall survival: median 23.7 [(95% CI 19.4-28.0) versus 19.8 months (95% CI 14.9-24.7); HR, 0.57 (95% CI 0.32-1.02); P = 0.056].
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': ""Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples. Electronic address: fortunato.ciardiello@unina2.it.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Normanno', 'Affiliation': ""Cell Biology and Biotherapy Unit, National Cancer Institute 'Fondazione Giovanni Pascale', Naples.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martinelli', 'Affiliation': ""Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Troiani', 'Affiliation': ""Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Hospital SS. Annunziata, Taranto.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cardone', 'Affiliation': ""Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nappi', 'Affiliation': ""Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples.""}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Bordonaro', 'Affiliation': 'Medical Oncology, Hospital Garibaldi, Nesima, Catania.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rachiglio', 'Affiliation': ""Cell Biology and Biotherapy Unit, National Cancer Institute 'Fondazione Giovanni Pascale', Naples; Laboratory of Pharmacogenomics, Centro di Ricerche Oncologiche di Mercogliano (CROM)-National Cancer Institute 'Fondazione Giovanni Pascale', Naples.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lambiase', 'Affiliation': ""Cell Biology and Biotherapy Unit, National Cancer Institute 'Fondazione Giovanni Pascale', Naples; Laboratory of Pharmacogenomics, Centro di Ricerche Oncologiche di Mercogliano (CROM)-National Cancer Institute 'Fondazione Giovanni Pascale', Naples.""}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Latiano', 'Affiliation': 'Medical Oncology, Hospital Casa Sollievo della Sofferenza, San Giovanni Rotondo (Foggia).'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Modoni', 'Affiliation': 'Medical Oncology, Hospital SS. Annunziata, Taranto.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cordio', 'Affiliation': 'Medical Oncology, Hospital Garibaldi, Nesima, Catania.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Giuliani', 'Affiliation': 'Medical Oncology, National Cancer Institute Giovanni Paolo II, Bari.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Biglietto', 'Affiliation': ""Medical Oncology, Hospital 'A. Cardarelli', Naples.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Montesarchio', 'Affiliation': 'Medical Oncology, Hospital Monaldi- Azienda Ospedaliera dei Colli, Naples.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Medical Oncology, University Hospital A. Gemelli, Rome.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tonini', 'Affiliation': 'Policlinico Universitario Campus Bio-Medico, Rome.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Hospital A. Perrino, Brindisi.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Febbraro', 'Affiliation': 'Medical Oncology, Hospital Sacro Cuore di Gesù, Fatebenefratelli, Benevento.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'GOIM Trial Office, Bari, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'De Vita', 'Affiliation': ""Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Orditura', 'Affiliation': ""Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, National Cancer Institute Giovanni Paolo II, Bari.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Hospital Casa Sollievo della Sofferenza, San Giovanni Rotondo (Foggia).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw136']
953,26018127,"""Keeping Moving"": factors associated with sedentary behaviour among older people recruited to an exercise promotion trial in general practice.","BACKGROUND


Sedentary behaviour is detrimental to health, even in those who achieve recommended levels of physical activity. Efforts to increase physical activity in older people so that they reach beneficial levels have been disappointing. Reducing sedentary behaviour may improve health and be less demanding of older people, but it is not clear how to achieve this. We explored the characteristics of sedentary older people enrolled into an exercise promotion trial to gain insights about those who were sedentary but wanted to increase activity.
METHOD


Participants in the ProAct65+ trial (2009-2013) were categorised as sedentary or not using a self-report questionnaire. Demographic data, health status, self-rated function and physical test performance were examined for each group. 1104 participants aged 65 & over were included in the secondary analysis of trial data from older people recruited via general practice. Results were analysed using logistic regression with stepwise backward elimination.
RESULTS


Three hundred eighty seven (35 %) of the study sample were characterised as sedentary. The likelihood of being categorised as sedentary increased with an abnormal BMI (<18.5 or >25 g/m(2)) (Odds Ratio 1.740, CI 1.248-2.425), ever smoking (OR 1.420, CI 1.042-1.934) and with every additional medication prescribed (OR 1.069, CI 1.016-1.124). Participants reporting better self-rated physical health (SF-12) were less likely to be sedentary; (OR 0.961, 0.936-0.987). Participants' sedentary behaviour was not associated with gender, age, income, education, falls, functional fitness, quality of life or number of co-morbidities.
CONCLUSION


Some sedentary older adults will respond positively to an invitation to join an exercise study. Those who did so in this study had poor self-rated health, abnormal BMI, a history of smoking, and multiple medication use, and are therefore likely to benefit from an exercise intervention.
TRIAL REGISTRATION


ISRCTN reference: ISRCTN43453770.",2015,"Reducing sedentary behaviour may improve health and be less demanding of older people, but it is not clear how to achieve this.","['Participants in the ProAct65+ trial (2009-2013) were categorised as sedentary or not using a self-report questionnaire', 'Three hundred eighty seven (35 %) of the study sample were characterised as sedentary', 'sedentary older adults', 'older people recruited to an exercise promotion trial in general practice', '1104 participants aged 65 & over were included in the secondary analysis of trial data from older people recruited via general practice', 'sedentary older people enrolled into an', 'older people']",['exercise promotion'],"['physical activity', 'self-rated physical health (SF-12', 'Demographic data, health status, self-rated function and physical test performance']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0582434', 'cui_str': 'Giving encouragement to exercise (procedure)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0582434', 'cui_str': 'Giving encouragement to exercise (procedure)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",2013.0,0.129321,"Reducing sedentary behaviour may improve health and be less demanding of older people, but it is not clear how to achieve this.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Heseltine', 'Affiliation': 'Department of Primary Care & Population Health, University College London, Royal Free Campus, Rowland Hill St., London, NW3 2PF, UK. ruth_heseltine@hotmail.com.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'School of Health & Life Sciences, Glasgow Caledonian University, Cowcaddens Rd, Glasgow, Lanarkshire, G4 0BA, UK. dawn.skelton@gcu.ac.uk.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Division of Primary Care, University of Nottingham, Floor 13, Tower Building, University Park, Nottingham, NG7 2RD, UK. denise.kendrick@nottingham.ac.uk.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. richard.morris@bristol.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Department of Primary Care & Population Health, University College London, Royal Free Campus, Rowland Hill St., London, NW3 2PF, UK. m.griffin@ucl.ac.uk.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Haworth', 'Affiliation': 'Department of Primary Care & Population Health, University College London, Royal Free Campus, Rowland Hill St., London, NW3 2PF, UK. d.haworth@ucl.ac.uk.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Masud', 'Affiliation': 'Nottingham University Hospital NHS Trust, Derby Rd, Nottingham, NG7 2UH, UK. tash.masud@nottingham.ac.uk.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Iliffe', 'Affiliation': 'Department of Primary Care & Population Health, University College London, Royal Free Campus, Rowland Hill St., London, NW3 2PF, UK. s.iliffe@ucl.ac.uk.'}]",BMC family practice,['10.1186/s12875-015-0284-z']
954,32412700,"Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Patients Who Have Active Suicidal Ideation With Intent: Double-Blind, Randomized Study (ASPIRE I).","OBJECTIVE


To compare esketamine to placebo, each in addition to standard-of-care treatment, for rapidly reducing major depressive disorder symptoms, including suicidal ideation.
METHODS


This phase 3, double-blind, multicenter study (ASPIRE I), conducted between June 2017 and December 2018, enrolled 226 adults having major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria, active suicidal ideation with intent, and need for psychiatric hospitalization. Patients were randomized 1:1 to esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, each with comprehensive standard-of-care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant[s] therapy). Change from baseline to 24 hours post-first dose in Montgomery-Asberg Depression Rating Scale (MADRS) total score (primary endpoint) was analyzed using analysis of covariance (ANCOVA), and change in Clinical Global Impression of Severity of Suicidality Revised version (CGI-SS-r; key secondary endpoint) score was analyzed using ANCOVA on ranks with treatment difference estimated using the Hodges-Lehmann estimate.
RESULTS


Greater improvement in MADRS total score was observed with esketamine + standard-of-care versus placebo + standard-of-care at 24 hours (least-squares mean difference [SE]: -3.8 [1.39]; 95% CI, -6.56 to -1.09; 2-sided P = .006), as well as at earlier (4 hours) and later time points during 4-week double-blind treatment. The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107). The most common adverse events among esketamine-treated patients were dizziness, dissociation, headache, nausea, and somnolence.
CONCLUSIONS


These findings demonstrate rapid and robust efficacy of esketamine nasal spray in reducing depressive symptoms in severely ill patients with major depressive disorder who have active suicidal ideation with intent.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03039192.",2020,The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107).,"['severely ill patients with major depressive disorder who have active suicidal ideation with intent', 'June 2017 and December 2018, enrolled 226 adults having major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria, active suicidal ideation with intent, and need for psychiatric hospitalization', 'Patients', 'Who Have Active Suicidal Ideation With Intent']","['placebo', 'esketamine nasal spray', 'esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, each with comprehensive standard-of-care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant[s] therapy', 'Esketamine Nasal Spray']","['severity of suicidality', 'Clinical Global Impression of Severity of Suicidality Revised version (CGI-SS-r; key secondary endpoint) score', 'MADRS total score', 'dizziness, dissociation, headache, nausea, and somnolence', 'Major Depressive Disorder Symptoms', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score', 'depressive symptoms']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0749133', 'cui_str': 'Active suicidal ideation'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",226.0,0.482575,The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107).,"[{'ForeName': 'Dong-Jing', 'Initials': 'DJ', 'LastName': 'Fu', 'Affiliation': 'Director, Neuroscience Clinical Development, Janssen Research and Development, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560. dfu@its.jnj.com.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Quantitative Sciences, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hough', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Husseini', 'Initials': 'H', 'LastName': 'Manji', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, San Diego, California, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Canuso', 'Affiliation': 'Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13191']
955,31570124,Impact of a mindfulness-based intervention on undergraduate pharmacy students' stress and distress: Quantitative results of a mixed-methods study.,"INTRODUCTION


Stress negatively impacts upon physical and mental health. Pharmacy students demonstrate higher stress than the general population. Mindfulness may improve pharmacy students' stress and distress levels. The purpose of this study was to assess the quantitative effects of a mindfulness-based intervention on pharmacy student stress, distress, burnout, and mindfulness levels.
METHODS


A quasi-randomised controlled trial was conducted at an Irish pharmacy school during the 2016 to 2017 academic year. The intervention group completed a four-week mindfulness course. The waitlist control group received only usual education. Participants completed a demographics form, the Perceived Stress Scale, the General Health Questionnaire, the Maslach Burnout Inventory Student Survey, and the Five Facet Mindfulness Questionnaire at baseline and immediately post-intervention.
RESULTS


Full data were gathered and analysed for 99 students (51 intervention, 48 control, 66.7% female). There were no significant differences between the intervention and control groups at baseline. Post-intervention, a large effect on mental distress was found (Partial Eta Squared 0.137) with the intervention group reporting statistically significantly lower distress than the control group (F (1,98) = 15.3, p < 0.005). Stress and distress were significantly improved for females (p = 0.026, p < 0.005), while males improved in the observing facet of mindfulness (p = 0.038). There was a positive association between attendance and these findings (r2 = 0.191, p < 0.005).
CONCLUSION


Female pharmacy students experienced improvements in mental distress and stress after participation in the intervention. Mindfulness may have a future role to play in pharmacy and healthcare education.",2019,"Stress and distress were significantly improved for females (p = 0.026, p < 0.005), while males improved in the observing facet of mindfulness (p = 0.038).","['99 students (51 intervention, 48 control, 66.7% female', 'A quasi-randomised controlled trial was conducted at an Irish pharmacy school during the 2016 to 2017 academic year', 'Female pharmacy students', ""undergraduate pharmacy students' stress and distress""]","['waitlist control group received only usual education', 'mindfulness-based intervention']","[""pharmacy students' stress and distress levels"", 'Perceived Stress Scale, the General Health Questionnaire, the Maslach Burnout Inventory Student Survey, and the Five Facet Mindfulness Questionnaire', 'mental distress', 'distress', 'pharmacy student stress, distress, burnout, and mindfulness levels', 'observing facet of mindfulness', 'Stress and distress', 'mental distress and stress']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0036381', 'cui_str': 'Schools, Pharmacy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235109', 'cui_str': 'Mental distress (finding)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}]",,0.0222224,"Stress and distress were significantly improved for females (p = 0.026, p < 0.005), while males improved in the observing facet of mindfulness (p = 0.038).","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': ""O'Driscoll"", 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: michelle.odriscoll@ucc.ie.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Sahm', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland; Pharmacy Department, Mercy University Hospital, Cork, Ireland. Electronic address: l.sahm@ucc.ie.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Byrne', 'Affiliation': 'Mindfulness Centre for Professional Training in Ireland, 33 Pembroke Street Lower, Dublin 2, Ireland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Lambert', 'Affiliation': 'School of Applied Psychology, University College Cork, Ireland. Electronic address: sharon.lambert@ucc.ie.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Ireland. Electronic address: Stephen.byrne@ucc.ie.'}]",Currents in pharmacy teaching & learning,['10.1016/j.cptl.2019.05.014']
956,32492168,A metabolomic study of red and processed meat intake and acylcarnitine concentrations in human urine and blood.,"BACKGROUND


Acylcarnitines (ACs) play a major role in fatty acid metabolism and are potential markers of metabolic dysfunction with higher blood concentrations reported in obese and diabetic individuals. Diet, and in particular red and processed meat intake, has been shown to influence AC concentrations but data on the effect of meat consumption on AC concentrations is limited.
OBJECTIVES


To investigate the effect of red and processed meat intake on AC concentrations in plasma and urine using a randomized controlled trial with replication in an observational cohort.
METHODS


In the randomized crossover trial, 12 volunteers successively consumed 2 different diets containing either pork or tofu for 3 d each. A panel of 44 ACs including several oxidized ACs was analyzed by LC-MS in plasma and urine samples collected after the 3-d period. ACs that were associated with pork intake were then measured in urine (n = 474) and serum samples (n = 451) from the European Prospective Investigation into Cancer and nutrition (EPIC) study and tested for associations with habitual red and processed meat intake derived from dietary questionnaires.
RESULTS


In urine samples from the intervention study, pork intake was positively associated with concentrations of 18 short- and medium-chain ACs. Eleven of these were also positively associated with habitual red and processed meat intake in the EPIC cross-sectional study. In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
CONCLUSIONS


AC concentrations in urine and blood were associated with red meat intake in both a highly controlled intervention study and in subjects of a cross-sectional study. Our data on the role of meat intake on this important pathway of fatty acid and energy metabolism may help understanding the role of red meat consumption in the etiology of some chronic diseases. This trial was registered at Clinicaltrials.gov as NCT03354130.",2020,"In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
","['12 volunteers successively consumed 2 different diets containing either pork or tofu for 3 d each', 'obese and diabetic individuals', 'human urine and blood']",['red and processed meat intake'],"['red meat intake', 'habitual red and processed meat intake', 'several oxidized ACs']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0452867', 'cui_str': 'Pork'}, {'cui': 'C0453233', 'cui_str': 'Tofu'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0556213', 'cui_str': 'Processed meat intake'}]","[{'cui': 'C0556202', 'cui_str': 'Red meat intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0556213', 'cui_str': 'Processed meat intake'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}]",12.0,0.0566447,"In blood, C18:0 was positively associated with red meat intake in both the intervention study (q = 0.004, Student's t-test) and the cross-sectional study (q = 0.033, linear regression).
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Wedekind', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Keski-Rahkonen', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Viallon', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Rothwell', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Agnetha Linn', 'Initials': 'AL', 'LastName': 'Rostgaard-Hansen', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Torkjel M', 'Initials': 'TM', 'LastName': 'Sandanger', 'Affiliation': 'Department of Community Medicine, UiT the Arctic university of Norway, Tromsø, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jakszyn', 'Affiliation': 'Unit of Nutrition and Cancer, Cancer Epidemiology Research Programme, Catalan Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmidt', 'Affiliation': 'Cancer Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pala', 'Affiliation': 'Epidemiology and Prevention Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano,Italy.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Vermeulen', 'Affiliation': 'Division of Environmental Epidemiology, \xa0Institute for Risk Assessment Sciences, Utrecht University, \xa0Utrecht, The Netherlands.'}, {'ForeName': 'Matthias B', 'Initials': 'MB', 'LastName': 'Schulze', 'Affiliation': 'Department of Molecular Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Theron', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Trichopoulou', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Peppa', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'La Vechia', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Masala', 'Affiliation': 'Cancer Risk Factors and Life-Style\xa0Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO) , Florence, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Tumino', 'Affiliation': 'Cancer Registry and Histopathology Department, Provincial Health Authority (ASP) Ragusa, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Sacerdote', 'Affiliation': 'Unit of Cancer Epidemiology, Città della Salute e della Scienza University-Hospital and Center for Cancer Prevention (CPO), Turin, Italy.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Wittenbecher', 'Affiliation': 'Department of Molecular Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Maria Santucci', 'Initials': 'MS', 'LastName': 'de Magistris', 'Affiliation': 'Azienda Ospedialiera Universitaria (A.O.U.) Federico II, Naples, Italy.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Dahm', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Severi', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Francesca Romana', 'Initials': 'FR', 'LastName': 'Mancini', 'Affiliation': 'Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France.'}, {'ForeName': 'Elisabete', 'Initials': 'E', 'LastName': 'Weiderpass', 'Affiliation': 'International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gunter', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Huybrechts', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Scalbert', 'Affiliation': 'Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa140']
957,31865423,n-3 PUFA and caloric restriction diet alters lipidomic profiles in obese men with metabolic syndrome: a preliminary open study.,"PURPOSE


For people with metabolic syndrome (MetS), altering the macronutrient composition of their diets might ameliorate metabolic abnormalities. The common method of clinical assessment only measures total lipid concentrations but ignores the individual species that contribute to these total concentrations. Thus, to predict the amelioration of MetS following caloric restriction (CR) and the intake of fish oil, we used lipidomics to investigate changes in plasma lipids and identify potential lipid metabolites.
METHODS


Lipidomics was performed using ultra-high-performance liquid chromatography-tandem mass spectrometry on plasma samples from a clinical trial conducted over 12 weeks. Subjects were randomized into two groups: CR (n = 12) and CR with fish oil (CRF, n = 9). Anthropometric and clinical parameters were measured and correlated with plasma lipidomics data.
RESULTS


Compared with baseline, significant differences were observed in body weight, waist circumference, blood pressure and interleukin-6 in both groups, but triglyceride (TG) levels significantly decreased in only the CRF group (all p < 0.05). A total of 138 lipid species were identified. Levels of species containing long-chain polyunsaturated fatty acids were significantly elevated-greater than twofold-following fish oil intake, these included TG (60:9) and phosphatidylcholine (p40:6) (all q < 0.05). TG (60:9) tended to correlate negatively with body weight, body mass index, blood pressure, and HbA1c following fish oil intake.
CONCLUSION


CR and fish oil can ameliorate MetS features, including anthropometric parameters, blood pressure, and blood lipid concentrations. The levels of particular lipid species such as TG-containing docosapentaenoic acid were elevated post-intervention and negatively associated with MetS features. TG (60:9) may be proposed as a lipid metabolite to predict amelioration in MetS following the intake of CR and fish oil.",2020,"Levels of species containing long-chain polyunsaturated fatty acids were significantly elevated-greater than twofold-following fish oil intake, these included TG (60:9) and phosphatidylcholine (p40:6) (all q < 0.05).","['obese men with metabolic syndrome', 'people with metabolic syndrome (MetS']","['ultra-high-performance liquid chromatography-tandem mass spectrometry', 'CR and fish oil', 'n-3 PUFA and caloric restriction diet', 'CR with fish oil (CRF', 'CRF']","['levels of particular lipid species such as TG-containing docosapentaenoic acid', 'body weight, waist circumference, blood pressure and interleukin-6', 'Levels of species containing long-chain polyunsaturated fatty acids', 'body weight, body mass index, blood pressure, and HbA1c following fish oil intake', 'anthropometric parameters, blood pressure, and blood lipid concentrations', 'triglyceride (TG) levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0008562', 'cui_str': 'Chromatography, High Speed Liquid'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid (C22:5 N3)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}]",,0.0532259,"Levels of species containing long-chain polyunsaturated fatty acids were significantly elevated-greater than twofold-following fish oil intake, these included TG (60:9) and phosphatidylcholine (p40:6) (all q < 0.05).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shabrina', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'T-H', 'Initials': 'TH', 'LastName': 'Tung', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'N T K', 'Initials': 'NTK', 'LastName': 'Nguyen', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'H-C', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'H-T', 'Initials': 'HT', 'LastName': 'Wu', 'Affiliation': 'Graduate Institute of Metabolism and Obesity Sciences, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Metabolism and Obesity Sciences, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'S-Y', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan. sihuang@tmu.edu.tw.'}]",European journal of nutrition,['10.1007/s00394-019-02149-4']
958,27051359,"A comparison between intrathecal clonidine and neostigmine as an adjuvant to bupivacaine in the subarachnoid block for elective abdominal hysterectomy operations: A prospective, double-blind and randomized controlled study.","BACKGROUND AND AIMS


Adjuvant to the local anesthetic agent has proven benefits when used intrathecally. With regards to intrathecal bupivacaine as control, we have compared in this study the effects of clonidine and neostigmine when co-administered intrathecally with hyperbaric (0.5%) bupivacaine for abdominal hysterectomy.
MATERIALS AND METHODS


This prospective, randomized, double-blind study was conducted from May 2009 to June 2011. A total of 150 patients of American Society of Anaesthesiology grades I and II scheduled for abdominal hysterectomy under spinal anesthesia were randomly allocated into three groups. A volume of 3 ml of 0.5% hyperbaric bupivacaine was respectively added 1 ml solution containing 5% dextrose and 75 mcg of neostigmine in Group N, 1 ml containing 5% dextrose and 30 mcg of clonidine in Group C and 1 ml of 5% dextrose in Group D (control). We compared the sensory and motor block, the surgical condition, the duration of spinal analgesia and the side-effect profile.
RESULTS AND OBSERVATIONS


Sensory and motor blocks and duration of spinal analgesia were significantly increased in both Group C and Group N compared to Group D. More incidences of Nausea and vomiting were observed in Group N compared to other groups. The surgical condition was poorer in Group N compared to Group C.
CONCLUSION


Both intrathecal clonidine and neostigmine increase the bupivacaine-induced spinal block. However, clonidine provides better surgical condition and fewer incidences of nausea and vomiting.",2016,"RESULTS AND OBSERVATIONS


Sensory and motor blocks and duration of spinal analgesia were significantly increased in both Group C and Group N compared to Group D.","['I and II scheduled for abdominal hysterectomy under spinal anesthesia', 'May 2009 to June 2011', 'elective abdominal hysterectomy operations', '150 patients of American Society of Anaesthesiology grades']","['clonidine and neostigmine', 'hyperbaric bupivacaine', 'intrathecal clonidine', 'neostigmine', 'dextrose and 30 mcg of clonidine', 'bupivacaine', 'intrathecal bupivacaine', 'clonidine', 'intrathecal clonidine and neostigmine', 'hyperbaric (0.5%) bupivacaine']","['Nausea and vomiting', 'nausea and vomiting', 'Sensory and motor blocks and duration of spinal analgesia']","[{'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}]",,0.146148,"RESULTS AND OBSERVATIONS


Sensory and motor blocks and duration of spinal analgesia were significantly increased in both Group C and Group N compared to Group D.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bhar', 'Affiliation': 'Department of Anaesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'RoyBasunia', 'Affiliation': 'Department of Anaesthesiology, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kundu', 'Affiliation': 'Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Mondal', 'Affiliation': 'Department of Gynecology and Obstetrics, Midnapore Medical College and Hospital, Midnapore, West Bengal, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Halder', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mandal', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of Gynecology and Obstetrics, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.168797']
959,32418801,Primary Care Cluster RCT to Increase Diabetes Prevention Program Referrals.,"INTRODUCTION


The Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic.
STUDY DESIGN


A pragmatic, cluster randomized, mixed-methods study.
SETTING/PARTICPANTS


Clusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians.
INTERVENTION


Implementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes.
MAIN OUTCOME MEASURES


The primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019.
RESULTS


Study clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful.
CONCLUSIONS


Intervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.",2020,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","['Diabetes Prevention Program referrals at a primary care clinic', 'Clusters were teams of primary care clinicians from 2 primary care clinics', '2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4']",[],['referral of patients with prediabetes to the institutional Diabetes Prevention Program'],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}]",[],"[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",2992.0,0.0201638,"Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730).","[{'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Keck', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky; Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky. Electronic address: james.keck@uky.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Roper', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Hieronymus', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky; University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Alisha R', 'Initials': 'AR', 'LastName': 'Thomas', 'Affiliation': 'Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Zhengyuan', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, University of Kentucky College of Public Health, Lexington, Kentucky.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Fowlkes', 'Affiliation': 'University of Kentucky Barnstable Brown Diabetes Center, Lexington, Kentucky.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cardarelli', 'Affiliation': 'Department of Family and Community Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.008']
960,25879726,Protocol for Get Moving: a randomised controlled trial to assess the effectiveness of three minimal contact interventions to promote fitness and physical activity in working adults.,"BACKGROUND


Web-based interventions for physical activity offer several advantages over face-to-face, print-and telephone-based interventions and are scalable and potentially cost-effective. Recent reviews of web-based interventions in adults show that they have positive but small effects on physical activity but identify a number of limitations including a reliance on self-report measures of outcome. This trial used an objective measure of physical activity to assess the effectiveness of three minimal contact interventions: 1) A multi-component web-based intervention incorporating objective monitoring and graphical feedback of physical activity; 2) A version of the first intervention that consisted only of objective monitoring plus web-based graphical feedback; and 3) Self-monitoring of physical activity using a paper diary.
METHODS/DESIGN


Get Moving is an individually randomised controlled trial with allocation of 488 participants to one of three interventions or to a no-intervention control group. Participants are physically inactive working adults aged 18-65 years. They attended a baseline assessment session at which anthropometric, biological and questionnaire measures were taken and they completed a treadmill exercise test. They then wore a combined movement and heart rate monitor for six days and nights before being randomised to one of the four trial arms. The baseline measures were repeated at the follow-up assessment which took place approximately 12 weeks post-randomisation, conducted by staff blind to group allocation. Participants wore the movement and heart rate monitor for six days and nights before this. The co-primary outcomes are: physical activity energy expenditure measured using individually calibrated combined heart-rate and movement data; and cardiorespiratory fitness measured using a sub-maximal treadmill exercise test.
DISCUSSION


Strengths of the trial include the use of an objective measure of physical activity, a measure of cardiorespiratory fitness, relatively large sample size and the use of robust methods of randomisation, allocation concealment and blinding to outcome assessment. Get Moving will contribute to the evidence base on minimal contact interventions for increasing physical activity. The interventions could be implemented in other settings such as primary care.
TRIAL REGISTRATION


ISRCTN31844443. Registered 18 June 2010.",2015,"The baseline measures were repeated at the follow-up assessment which took place approximately 12 weeks post-randomisation, conducted by staff blind to group allocation.","['Participants are physically inactive working adults aged 18-65 years', 'working adults', '488 participants to one of three interventions or to a no-intervention control group']","['minimal contact interventions', 'objective monitoring plus web-based graphical feedback; and 3) Self-monitoring of physical activity using a paper diary']",['physical activity energy expenditure measured using individually calibrated combined heart-rate and movement data; and cardiorespiratory fitness measured using a sub-maximal treadmill exercise test'],"[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]",,0.160611,"The baseline measures were repeated at the follow-up assessment which took place approximately 12 weeks post-randomisation, conducted by staff blind to group allocation.","[{'ForeName': 'Andrew J M', 'Initials': 'AJ', 'LastName': 'Cooper', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, School of Clinical Medicine, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, UK. andrew.cooper@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Dearnley', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Robinson Way, Cambridge, CB2 0SR, UK. kd339@medschl.cam.ac.uk.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Williams', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Robinson Way, Cambridge, CB2 0SR, UK. kmw36@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, School of Clinical Medicine, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, UK. stephen.sharp@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Esther M F', 'Initials': 'EM', 'LastName': 'van Sluijs', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, School of Clinical Medicine, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, UK. esther.vansluijs@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, School of Clinical Medicine, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, UK. soren.brage@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Robinson Way, Cambridge, CB2 0SR, UK. srs34@medschl.cam.ac.uk.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, School of Clinical Medicine, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, UK. simon.griffin@mrc-epid.cam.ac.uk.'}]",BMC public health,['10.1186/s12889-015-1654-0']
961,25884235,Feasibility of a ward-based psychological intervention to improve staff and patient relationships in psychiatric rehabilitation settings.,"OBJECTIVES


Recent inquiries highlight the anti-therapeutic nature of inpatient psychiatric care. We aim to assess the feasibility and potential efficacy of a ward-based psychological intervention to improve staff-patient relationships in psychiatric rehabilitation settings.
METHODS


A single-blind cluster randomized design compared the intervention with treatment as usual (TAU) on measures of relationships, staff well-being, and patient functioning. Assessments were carried out at baseline and at 6 months.
RESULTS


Fifty-one patients and 85 staff were recruited across 10 wards. Fifteen patients and 11 staff were lost to follow-up, with primary reason being ward discharge. Uptake to the intervention was variable but on average lower than anticipated (mean number of sessions 3.5, range 0-11). Despite this lower than anticipated uptake, compared with TAU, patients in the intervention arm felt significantly less criticized by their key workers and reported improvements in ward atmosphere. Staff in the intervention arm also reported significantly lower levels of depersonalization post-intervention. Although trend level data favoured the intervention group, in this relatively small feasibility study, we were not able to demonstrate statistically significant differences between the groups in terms of staff perceptions of relationships, staff stress, and longer-term patient outcomes.
CONCLUSIONS


This psychologically informed ward-based intervention shows potential in improving relationships, although findings and feasibility may be enhanced if further measures are put into place to ensure that all members of the team attend intervention sessions on a more frequent basis. Loss at follow-up due to discharge also needs to be factored into future power calculations.
PRACTITIONER POINTS


It is feasible to implement and trial a ward-based psychological intervention (team-based formulation) in long-stay psychiatric settings using a cluster randomized design. Developing psychological formulations with frontline ward staff around patients' needs has the potential to improve staff-patient relationships. The small sample size and loss of data at follow-up may have limited the power of the study to detect the full range of treatment effects. Larger trials are needed to assess the reliability and generalizability of our findings across different wards.",2016,Staff in the intervention arm also reported significantly lower levels of depersonalization post-intervention.,"['psychiatric rehabilitation settings', 'Fifty-one patients and 85 staff were recruited across 10 wards', 'Fifteen patients and 11 staff were lost to follow-up, with primary reason being ward discharge']","['ward-based psychological intervention', 'intervention with treatment as usual (TAU']","['staff perceptions of relationships, staff stress, and longer-term patient outcomes', 'feasibility and potential efficacy']","[{'cui': 'C0204512', 'cui_str': 'Mental Health Rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",15.0,0.0558162,Staff in the intervention arm also reported significantly lower levels of depersonalization post-intervention.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Berry', 'Affiliation': 'University of Manchester, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Haddock', 'Affiliation': 'University of Manchester, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kellett', 'Affiliation': 'University of Sheffield, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'University of Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Drake', 'Affiliation': 'University of Manchester, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Barrowclough', 'Affiliation': 'University of Manchester, UK.'}]",The British journal of clinical psychology,['10.1111/bjc.12082']
962,29734211,Early Versus Standard Colonoscopy: A Randomized Controlled Trial in Patients With Acute Lower Gastrointestinal Bleeding: Results of the BLEED Study.,"GOALS


The aim of our study was to examine differences in length of hospital stay (LOHS) between patients with lower gastrointestinal bleeding who received either an early colonoscopy (within 24 h of presentation) or a standard colonoscopy (within 1 to 3 d).
BACKGROUND


Diagnostic management of lower gastrointestinal bleeding has been extensively debated in recent literature, especially whether colonoscopy within 24 hours of presentation is feasible and safe.
STUDY


In this single center, nonblinded, randomized controlled trial, patients presenting at the emergency department with acute hematochezia were eligible if they required hospital admission. A total of 132 patients were included. Primary outcome was LOHS. Secondary outcomes included yield of colonoscopy, blood transfusion requirements, recurrent bleedings, complications, interventions related to complications, and 30-day mortality. The follow-up period was 1 month.
RESULTS


In total, 63 patients were randomized for <24 hours colonoscopy and 69 for standard colonoscopy. In the intention to treat analysis, LOHS was significantly lower in patients that underwent an early colonoscopy, compared with the standard group: median 2.0 days (inter quartile range, 2.0 to 4.0) versus median 3.0 days (inter quartile range, 2.0 to 4.0) (P=0.009). Recurrent bleedings and hospital readmissions were significantly more frequent in the <24-hour group: 13% versus 3% (P=0.04) and 11% versus 2% (P=0.02), respectively. No difference was observed regarding the number of patients diagnosed with a confirmed or presumptive bleeding source. In both groups, blood transfusion rate was similar and 30-day mortality was 0.
CONCLUSIONS


Early colonoscopy reduces LOHS, but also results in lower clinical efficacy compared with standard colonoscopy.",2019,"Recurrent bleedings and hospital readmissions were significantly more frequent in the <24-hour group: 13% versus 3% (P=0.04) and 11% versus 2% (P=0.02), respectively.","['Patients With Acute Lower Gastrointestinal Bleeding', 'patients with lower gastrointestinal bleeding who received either an early colonoscopy (within 24\u2009h of presentation) or a', '63 patients were randomized for <24 hours colonoscopy and 69 for standard colonoscopy', 'patients presenting at the emergency department with acute hematochezia were eligible if they required hospital admission', 'A total of 132 patients were included']","['standard colonoscopy', 'Standard Colonoscopy']","['Recurrent bleedings and hospital readmissions', 'length of hospital stay (LOHS', '30-day mortality', 'number of patients diagnosed with a confirmed or presumptive bleeding source', 'yield of colonoscopy, blood transfusion requirements, recurrent bleedings, complications, interventions related to complications, and 30-day mortality', 'LOHS', 'blood transfusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266811', 'cui_str': 'Acute lower gastrointestinal hemorrhage (disorder)'}, {'cui': 'C0024050', 'cui_str': 'Lower gastrointestinal hemorrhage (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",132.0,0.170084,"Recurrent bleedings and hospital readmissions were significantly more frequent in the <24-hour group: 13% versus 3% (P=0.04) and 11% versus 2% (P=0.02), respectively.","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'van Rongen', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Bregje J W', 'Initials': 'BJW', 'LastName': 'Thomassen', 'Affiliation': 'Landsteiner Institute, Haaglanden Medical Centre, The Hague, The Netherlands.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'Perk', 'Affiliation': 'Department of Gastroenterology.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001048']
963,31194946,A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis.,"OBJECTIVE


To test the efficacy of low-dose extracorporeal shockwave therapy (ESWT) on osteoarthritis knee pain, lower limb function, and cartilage alteration for patients with knee osteoarthritis.
DESIGN


Randomized controlled trial with placebo control.
SETTING


Outpatient physical therapy clinics within a hospital network.
PARTICIPANTS


Eligible volunteers (N=63) with knee osteoarthritis (Kellgren-Lawrence grade II or III) were randomly assigned to 2 groups.
INTERVENTIONS


Patients in the experimental group received low-dose ESWT for 4 weeks while those in the placebo group got sham shockwave therapy. Both groups maintained a usual level of home exercise.
MAIN OUTCOME MEASURES


Knee pain and physical function were measured using a visual analog scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Lequesne index at baseline, 5 weeks, and 12 weeks. Cartilage alteration was measured analyzing the transverse relaxation time (T2) mapping.
RESULTS


The VAS score, WOMAC, and Lequesne index of the ESWT group were significantly better than those of the placebo group at 5 and 12 weeks (P<.05). Both groups showed improvement in pain and disability scores over the 12-week follow-up period (P<.05). In terms of imaging results, there was no significant difference in T2 values between groups during the trial, although T2 values of the ESWT group at 12 weeks significantly increased compared to those at baseline (P=.004). The number and prevalence of adverse effects were similar between the 2 groups, and no serious side effects were found.
CONCLUSIONS


A 4-week treatment of low-dose ESWT was superior to placebo for pain easement and functional improvement in patients with mild to moderate knee osteoarthritis but had some negative effects on articular cartilage.",2019,Both groups showed improvement in pain and disability scores over the 12-week follow-up period (p < 0.05).,"['patients with knee osteoarthritis', '63 eligible volunteers with knee osteoarthritis (Kellgren-Lawrence grade II or III', 'Outpatient PT clinics within a hospital network', 'patients with mild to moderate knee osteoarthritis']","['placebo', 'low-dose extracorporeal shock wave therapy (ESWT', 'placebo group got sham shock wave therapy', 'low-dose ESWT', 'low-dose extracorporeal shock wave therapy']","['Knee pain and physical function', 'Cartilage alteration', 'T2 transverse relaxation time mapping', 'visual analogue scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Lequesne index', 'VAS score, WOMAC index, and Lequesne index', 'pain and disability scores', 'osteoarthritis knee pain, lower limb function and cartilage alteration', 'T2 values', 'number and prevalence of adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",63.0,0.0576369,Both groups showed improvement in pain and disability scores over the 12-week follow-up period (p < 0.05).,"[{'ForeName': 'Zongye', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bangzhong', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China; Department of Rehabilitation Medicine, Zhujiajiao People's Hospital, Shanghai, China. Electronic address: liu.bangzhong@zs-hospital.sh.cn.""}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Deparment of Radiology, Huashan Hospital, Fudan University, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.04.020']
964,25319597,Domestic violence and mental health: a cross-sectional survey of women seeking help from domestic violence support services.,"BACKGROUND


Domestic violence and abuse (DVA) are associated with an increased risk of mental illness, but we know little about the mental health of female DVA survivors seeking support from domestic violence services.
OBJECTIVE


Domestic violence and abuse (DVA) are associated with an increased risk of mental illness, but we know little about the mental health of female DVA survivors seeking support from domestic violence services.
DESIGN


Baseline data on 260 women enrolled in a randomized controlled trial of a psychological intervention for DVA survivors was analyzed. We report prevalence of and associations between mental health status and severity of abuse at the time of recruitment. We used logistic and normal regression models for binary and continuous outcomes, respectively. Mental health measures used were: Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), Patient Health Questionnaire, Generalized Anxiety Disorder Assessment, and the Posttraumatic Diagnostic Scale (PDS) to measure posttraumatic stress disorder. The Composite Abuse Scale (CAS) measured abuse.
RESULTS


Exposure to DVA was high, with a mean CAS score of 56 (SD 34). The mean CORE-OM score was 18 (SD 8) with 76% above the clinical threshold (95% confidence interval: 70-81%). Depression and anxiety levels were high, with means close to clinical thresholds, and all respondents recorded PTSD scores above the clinical threshold. Symptoms of mental illness increased stepwise with increasing severity of DVA.
CONCLUSIONS


Exposure to DVA was high, with a mean CAS score of 56 (SD 34). The mean CORE-OM score was 18 (SD 8) with 76% above the clinical threshold (95% confidence interval: 70-81%). Depression and anxiety levels were high, with means close to clinical thresholds, and all respondents recorded PTSD scores above the clinical threshold. Symptoms of mental illness increased stepwise with increasing severity of DVA.",2014,Symptoms of mental illness increased stepwise with increasing severity of DVA.,"['260 women enrolled', 'Domestic violence and abuse (DVA', 'women seeking help from domestic violence support services']",['psychological intervention'],"['mean CORE-OM score', 'Depression and anxiety levels', 'mean CAS score', 'Composite Abuse Scale (CAS) measured abuse', 'PTSD scores', 'Domestic violence and mental health', 'Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), Patient Health Questionnaire, Generalized Anxiety Disorder Assessment, and the Posttraumatic Diagnostic Scale (PDS) to measure posttraumatic stress disorder']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0206073', 'cui_str': 'Domestic Violence'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0206073', 'cui_str': 'Domestic Violence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",260.0,0.0519963,Symptoms of mental illness increased stepwise with increasing severity of DVA.,"[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK; giulia.ferrari@bristol.ac.uk.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Agnew-Davies', 'Affiliation': 'Domestic Violence Training Ltd, Surrey, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': ""Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Howarth', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lynnmarie', 'Initials': 'L', 'LastName': 'Sardinha', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Feder', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK; School of Clinical Sciences, University of Bristol, Bristol, UK.'}]",Global health action,['10.3402/gha.v7.25519']
965,31776344,A clinical trial to evaluate the effect of the Mediterranean diet on smokers lung function.,"Data on the association between lung function and some dietary patterns have been published. However, it is not yet well known if whether the Mediterranean Diet (MD) pattern can preserve or improve lung function. Our purpose is to evaluate the effect of increased MD adherence on lung function in smokers. A multicenter, parallel, cluster-randomized, controlled clinical trial is proposed. A total of 566 active smokers (>10 packs-year), aged 25-75 years will be included, without previous respiratory disease and who sign an informed consent to participate. Twenty Primary Care Centres in Tarragona (Spain) will be randomly assigned to a control or an intervention group (1:1). All participants will receive advice to quit smoking, and the intervention group, a nutritional intervention (2 years) designed to increase MD adherence by: (1) annual visit to deliver personalized nutritional education, (2) annual telephone contact to reinforce the intervention, and (3) access to an online dietary blog. We will evaluate (annually for 2 years): pulmonary function by forced spirometry and MD adherence by a 14-item questionnaire and medical tests (oxidation, inflammation and consumption biomarkers). In a statistical analysis by intention-to-treat basis, with the individual smoker as unit of analysis, pulmonary function and MD adherence in both groups will be compared; logistic regression models will be applied to analyze their associations. We hope to observe an increased MD adherence that may prevent the deterioration of lung function in smokers without previous respiratory disease. This population may benefit from a dietary intervention, together with the recommendation of smoking cessation.",2019,We will evaluate (annually for 2 years):,"['smokers lung function', '566 active smokers (>10 packs-year), aged 25-75 years will be included, without previous respiratory disease and who sign an informed consent to participate', '2 years', 'smokers without previous respiratory disease', 'smokers', 'Twenty Primary Care Centres in Tarragona (Spain']","['Mediterranean diet', 'nutritional intervention (2 years) designed to increase MD adherence by: (1) annual visit to deliver personalized nutritional education, (2) annual telephone contact to reinforce the intervention, and (3) access to an online dietary blog']","['pulmonary function by forced spirometry and MD adherence by a 14-item questionnaire and medical tests (oxidation, inflammation and consumption biomarkers', 'MD adherence']","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2718046', 'cui_str': 'Blog'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",566.0,0.0336233,We will evaluate (annually for 2 years):,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Martín-Luján', 'Affiliation': ""Institut Català de la Salut, CAP El Morell. Institut Universitari d'Investigació en Atenció Primària-IDIAP Jordi Gol. School of Medicine and Health Sciences, Universitat Rovira i Virgili, Reus, Spain.""}, {'ForeName': 'Roxana-Elena', 'Initials': 'RE', 'LastName': 'Catalin', 'Affiliation': 'Institut Català de la Salut, CAP Bonavista, Carrer Set, 36, 43100, Tarragona, Spain. recatalin.tgn.ics@gencat.cat.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Salamanca-González', 'Affiliation': ""Research Support Unit Tarragona-Reus, Institut Universitari d'Investigació en Atenció Primària-IDIAP Jordi Gol, Tarragona, Spain.""}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Sorlí-Aguilar', 'Affiliation': ""Research Support Unit Tarragona-Reus, Institut Universitari d'Investigació en Atenció Primària-IDIAP Jordi Gol, Tarragona, Spain.""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Santigosa-Ayala', 'Affiliation': ""Institut Català de la Salut, CAP Sant Salvador, Institut Universitari d'Investigació en Atenció Primària-IDIAP Jordi Gol, School of Medicine and Health Sciences, Universitat Rovira i Virgili, Reus, Spain.""}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Valls-Zamora', 'Affiliation': ""Hospital Universitari Sant Joan, Institut d'Investigació Sanitària Pere Virgili (IISPV), Functional Nutrition, Oxidation and Cardiovascular Disease (NFOC-SALUT) group, Universitat Rovira i Virgili, Reus, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Martín-Vergara', 'Affiliation': 'Institut Català de la Salut, CAP Horts de Miró, Tarragona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Canela-Armengol', 'Affiliation': 'Institut Català de la Salut, CAP Dr Sarro, Tarragona, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Arija-Val', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària-IDIAP Jordi Gol, School of Medicine and Health Sciences, Universitat Rovira i Virgili, Reus, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà-Alberich', 'Affiliation': ""Hospital Universitari Sant Joan, Institut d'Investigació Sanitària Pere Virgili (IISPV), Functional Nutrition, Oxidation and Cardiovascular Disease (NFOC-SALUT) group, Universitat Rovira i Virgili, Reus, Spain.""}]",NPJ primary care respiratory medicine,['10.1038/s41533-019-0153-7']
966,24843339,"Pain relief after Arthroscopic Knee Surgery: A comparison of intra-articular ropivacaine, fentanyl, and dexmedetomidine: A prospective, double-blinded, randomized controlled study.","BACKGROUND


Postoperative pain is very common distressing symptom after any surgical procedure. Different drugs in different routes have been used for controlling post-arthroscopic pain. No one proved to be ideal. We have compared the analgesic effect of ropivacaine, fentanyl, and dexmedetomidine when administered through the intra-articular route in arthroscopic knee surgery.
MATERIALS AND METHODS


From March 2008 to July 2010, 99 patients undergoing arthroscopic knee surgery were randomly assigned into three groups (A,B,C) in a prospective double-blinded fashion. Group A received 10 ml of 0.75% ropivacaine, where Group B received 50 μg fentanyl, and Group C received 100 μg of dexmedetomidine through the intra-articular route at the end of procedure. Pain assessed using visual analog scale and diclofenac sodium given as rescue analgesia when VAS >4. Time of first analgesia request and total rescue analgesic used in 24 hours were calculated.
RESULTS


Demographic profiles are quite comparable among the groups. Time for requirement of first postoperative rescue analgesia in Group A was 380.61 ± 22.973 min, in Group B was 326.82 ± 17.131 min and in Group C was 244.09 ± 20.096 minutes. Total rescue analgesia requirement was less in Group A (1.394 ± 0.496) compared to Group B (1.758 ± 0.435) and Group C (2.546 ± 0.546). Group A had higher mean VAS score at 6(th) and 24(th) postoperative hours. No side effects found among the groups.
CONCLUSION


Therefore, it suggests that intra-articular ropivacaine gives better postoperative pain relief, with increased time of first analgesic request and decreased need of total postoperative analgesia compared to fentanyl and dexmedetomidine.",2014,Total rescue analgesia requirement was less in Group A (1.394 ± 0.496) compared to Group B (1.758 ± 0.435) and Group C (2.546 ± 0.546).,"['From March 2008 to July 2010, 99 patients undergoing arthroscopic knee surgery', 'after Arthroscopic Knee Surgery']","['10 ml of 0.75% ropivacaine', 'ropivacaine, fentanyl, and dexmedetomidine', 'ropivacaine', 'diclofenac sodium', 'dexmedetomidine']","['Pain relief', 'Total rescue analgesia requirement', 'total postoperative analgesia', 'postoperative pain relief', 'Time of first analgesia request and total rescue analgesic', 'mean VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}]","[{'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",99.0,0.109689,Total rescue analgesia requirement was less in Group A (1.394 ± 0.496) compared to Group B (1.758 ± 0.435) and Group C (2.546 ± 0.546).,"[{'ForeName': 'Mohammed Babrak', 'Initials': 'MB', 'LastName': 'Manuar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Bimal Kumar', 'Initials': 'BK', 'LastName': 'Hajra', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Soumyadip', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Dipankar', 'Initials': 'D', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of R.M.O cum CT, B.I.N, Kolkata, West Bengal, India.'}, {'ForeName': 'Ratul', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Department of R.M.O cum CT, B.I.N, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.130727']
967,24290333,Cost-utility of self-managed computer therapy for people with aphasia.,"OBJECTIVES


The aim of this study was to examine the potential cost-effectiveness of self-managed computer therapy for people with long-standing aphasia post stroke and to estimate the value of further research.
METHODS


The incremental cost-effectiveness ratio of computer therapy in addition to usual stimulation compared with usual stimulation alone was considered in people with long-standing aphasia using data from the CACTUS trial. A model-based approach was taken. Where possible the input parameters required for the model were obtained from the CACTUS trial data, a United Kingdom-based pilot randomized controlled trial that recruited thirty-four people with aphasia and randomized them to computer treatment or usual care. Cost-effectiveness was described using an incremental cost-effectiveness ratio (ICER) together with cost-effectiveness acceptability curves. A value of information analysis was undertaken to inform future research priorities.
RESULTS


The intervention had an ICER of £3,058 compared with usual care. The likelihood of the intervention being cost-effective was 75.8 percent at a cost-effectiveness threshold of £20,000 per QALY gained. The expected value of perfect information was £37 million.
CONCLUSIONS


Our results suggest that computer therapy for people with long-standing aphasia is likely to represent a cost-effective use of resources. However, our analysis is exploratory given the small size of the trial it is based upon and therefore our results are uncertain. Further research would be of high value, particularly with respect to the quality of life gain achieved by people who respond well to therapy.",2013,"The likelihood of the intervention being cost-effective was 75.8 percent at a cost-effectiveness threshold of £20,000 per QALY gained.","['people with aphasia', 'people with long-standing aphasia post stroke', 'people with long-standing aphasia using data from the CACTUS trial']","['usual stimulation alone', 'self-managed computer therapy']","['incremental cost-effectiveness ratio (ICER', 'Cost-effectiveness']","[{'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0330340', 'cui_str': 'Cactus'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0892993,"The likelihood of the intervention being cost-effective was 75.8 percent at a cost-effectiveness threshold of £20,000 per QALY gained.","[{'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Latimer', 'Affiliation': 'School of Health and Related Research, University of Sheffield.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dixon', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Palmer', 'Affiliation': ''}]",International journal of technology assessment in health care,['10.1017/S0266462313000421']
968,25512434,Randomized phase 2 trial of intracoronary nitrite during acute myocardial infarction.,"RATIONALE


Preclinical evidence demonstrates that inorganic nitrite, after its in situ conversion to nitric oxide, attenuates consequent myocardial reperfusion injury.
OBJECTIVE


We investigated whether intracoronary injection of nitrite during primary percutaneous coronary intervention might improve infarct size in ST-elevated myocardial infarction.
METHODS AND RESULTS


Patients undergoing primary percutaneous coronary intervention (n=80) were randomized to receive intracoronary (10 mL) sodium nitrite (1.8 μmol) or NaCl (placebo) before balloon inflation. The primary end point was infarct size assessed by measuring creatine kinase release. Secondary outcomes included infarct size assessed by troponin T release and by cardiac MRI on day 2. Baseline characteristics were similar between the groups. No evidence of differences in creatine kinase release (P=0.92), troponin T (P=0.85), or cardiac MRI-assessed infarct size (P=0.254) were evident. In contrast, there was an improvement [corrected] in myocardial salvage index (P=0.05) and reduction in [corrected] major adverse cardiac event at 1 year (2.6% versus 15.8%; P=0.04) in the nitrite group. In a 66-patient subgroup with thrombolysis in myocardial infarction ≤1 flow, there was reduced serum creatine kinase (P=0.030) and a 19% reduction in cardiac MRI-determined infarct size (P=0.034) with nitrite. No adverse effects of nitrite were detected.
CONCLUSIONS


In this phase II study, intracoronary nitrite infusion did not alter infarct size, although a trend to improved myocardial salvage index and a significant reduction in major adverse cardiac event was evident. In a subgroup of patients with thrombolysis in myocardial infarction flow ≤1, nitrite reduced infarct size and major adverse cardiac event and improved myocardial salvage index, indicating that a phase III clinical trial assessing intracoronary nitrite administration as an adjunct to percutaneous coronary intervention in ST-elevated myocardial infarction patients is warranted.
CLINICAL TRIAL REGISTRATION URL


http://www.clinicaltrials.gov. Unique identifier: NCT01584453.",2015,"No evidence of differences in creatine kinase release (P=0.92), troponin T (P=0.85), or cardiac MRI-assessed infarct size (P=0.254) were evident.","['Patients undergoing primary percutaneous coronary intervention (n=80', 'acute myocardial infarction']","['intracoronary (10 mL) sodium nitrite (1.8 μmol) or NaCl (placebo', 'intracoronary nitrite infusion', 'intracoronary nitrite', 'intracoronary injection of nitrite', 'percutaneous coronary intervention']","['serum creatine kinase', 'infarct size', 'cardiac MRI-determined infarct size', 'creatine kinase release', 'infarct size assessed by measuring creatine kinase release', 'myocardial salvage index', 'adverse effects of nitrite', 'infarct size assessed by troponin T release and by cardiac MRI on day 2', 'troponin T (P=0.85), or cardiac MRI-assessed infarct size', 'infarct size and major adverse cardiac event and improved myocardial salvage index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C0037532', 'cui_str': 'Sodium Nitrite'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0858112', 'cui_str': 'Serum creatine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0412692', 'cui_str': 'Magnetic resonance imaging of heart'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",80.0,0.350562,"No evidence of differences in creatine kinase release (P=0.92), troponin T (P=0.85), or cardiac MRI-assessed infarct size (P=0.254) were evident.","[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Jones', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Pellaton', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Shanti', 'Initials': 'S', 'LastName': 'Velmurugan', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Krishnaraj Sinha', 'Initials': 'KS', 'LastName': 'Rathod', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Mervyn', 'Initials': 'M', 'LastName': 'Andiapen', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Sotiris', 'Initials': 'S', 'LastName': 'Antoniou', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'van Eijl', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Webb', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Westwood', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Mahesh K', 'Initials': 'MK', 'LastName': 'Parmar', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Ahluwalia', 'Affiliation': 'From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK. a.ahluwalia@qmul.ac.uk.'}]",Circulation research,['10.1161/CIRCRESAHA.116.305082']
969,24430319,Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial.,"IMPORTANCE


Intensive follow-up after surgery for colorectal cancer is common practice but is based on limited evidence.
OBJECTIVE


To assess the effect of scheduled blood measurement of carcinoembryonic antigen (CEA) and computed tomography (CT) as follow-up to detect recurrent colorectal cancer treatable with curative intent.
DESIGN, SETTING, AND PARTICIPANTS


Randomized clinical trial in 39 National Health Service hospitals in the United Kingdom; 1202 eligible participants were recruited between January 2003 and August 2009 who had undergone curative surgery for primary colorectal cancer, including adjuvant treatment if indicated, with no evidence of residual disease on investigation.
INTERVENTIONS


Participants were randomly assigned to 1 of 4 groups: CEA only (n = 300), CT only (n = 299), CEA+CT (n = 302), or minimum follow-up (n = 301). Blood CEA was measured every 3 months for 2 years, then every 6 months for 3 years; CT scans of the chest, abdomen, and pelvis were performed every 6 months for 2 years, then annually for 3 years; and the minimum follow-up group received follow-up if symptoms occurred.
MAIN OUTCOMES AND MEASURES


The primary outcome was surgical treatment of recurrence with curative intent; secondary outcomes were mortality (total and colorectal cancer), time to detection of recurrence, and survival after treatment of recurrence with curative intent.
RESULTS


After a mean 4.4 (SD, 0.8) years of observation, cancer recurrence was detected in 199 participants (16.6%; 95% CI, 14.5%-18.7%) overall; 71 of 1202 participants (5.9%; 95% CI, 4.6%-7.2%) were treated for recurrence with curative intent, with little difference according to Dukes staging (stage A, 5.1% [13/254]; stage B, 6.1% [34/553]; stage C, 6.2% [22/354]). Surgical treatment of recurrence with curative intent was 2.3% (7/301) in the minimum follow-up group, 6.7% (20/300) in the CEA group, 8% (24/299) in the CT group, and 6.6% (20/302) in the CEA+CT group. Compared with minimum follow-up, the absolute difference in the percentage of patients treated with curative intent in the CEA group was 4.4% (95% CI, 1.0%-7.9%; adjusted odds ratio [OR], 3.00; 95% CI, 1.23-7.33), in the CT group was 5.7% (95% CI, 2.2%-9.5%; adjusted OR, 3.63; 95% CI, 1.51-8.69), and in the CEA+CT group was 4.3% (95% CI, 1.0%-7.9%; adjusted OR, 3.10; 95% CI, 1.10-8.71). The number of deaths was not significantly different in the combined intensive monitoring groups (CEA, CT, and CEA+CT; 18.2% [164/901]) vs the minimum follow-up group (15.9% [48/301]; difference, 2.3%; 95% CI, -2.6% to 7.1%).
CONCLUSIONS AND RELEVANCE


Among patients who had undergone curative surgery for primary colorectal cancer, intensive imaging or CEA screening each provided an increased rate of surgical treatment of recurrence with curative intent compared with minimal follow-up; there was no advantage in combining CEA and CT. If there is a survival advantage to any strategy, it is likely to be small.
TRIAL REGISTRATION


isrctn.org Identifier: 41458548.",2014,"The number of deaths was not significantly different in the combined intensive monitoring groups (CEA, CT, and CEA+CT; 18.2% [164/901]) vs the minimum follow-up group (15.9% [48/301]; difference, 2.3%; 95% CI, -2.6% to 7.1%).
","['recurrent colorectal cancer treatable with curative intent', 'colorectal cancer', '39 National Health Service hospitals in the United Kingdom; 1202 eligible participants were recruited between January 2003 and August 2009 who had undergone curative surgery for primary colorectal cancer, including adjuvant treatment if indicated, with no evidence of residual disease on investigation', 'patients who had undergone curative surgery for primary colorectal cancer']","['carcinoembryonic antigen (CEA) and computed tomography (CT', 'CEA+CT', 'CEA']","['observation, cancer recurrence', 'rate of surgical treatment of recurrence', 'number of deaths', 'Blood CEA', 'surgical treatment of recurrence with curative intent; secondary outcomes were mortality (total and colorectal cancer), time to detection of recurrence, and survival after treatment of recurrence with curative intent']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005768'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]",1202.0,0.208423,"The number of deaths was not significantly different in the combined intensive monitoring groups (CEA, CT, and CEA+CT; 18.2% [164/901]) vs the minimum follow-up group (15.9% [48/301]; difference, 2.3%; 95% CI, -2.6% to 7.1%).
","[{'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Primrose', 'Affiliation': 'University of Southampton, Southampton, England.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perera', 'Affiliation': 'University of Oxford, Oxford, England.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'University of Oxford, Oxford, England.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rose', 'Affiliation': 'University of Oxford, Oxford, England.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fuller', 'Affiliation': 'University of Oxford, Oxford, England.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corkhill', 'Affiliation': 'University of Southampton, Southampton, England.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'University of Southampton, Southampton, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mant', 'Affiliation': 'University of Oxford, Oxford, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2013.285718']
970,25422601,"Prevention of altered hemodynamics after spinal anesthesia: A comparison of volume preloading with tetrastarch, succinylated gelatin and ringer lactate solution for the patients undergoing lower segment caesarean section.","BACKGROUND


Spinal anesthesia has replaced general anesthesia in obstetric practice. Hemodynamic instability is a common, but preventable complication of spinal anesthesia. Preloading the circulation with intravenous fluids is considered a safe and effective method of preventing hypotension following spinal anesthesia. We had conducted a study to compare the hemodynamic stability after volume preloading with either Ringer's lactate (RL) or tetrastarch hydroxyethyl starch (HES) or succinylated gelatin (SG) in the patients undergoing cesarean section under spinal anesthesia.
MATERIALS AND METHODS


It was a prospective, double-blinded and randomized controlled study. Ninety six ASA-I healthy, nonlaboring parturients were randomly divided in 3 groups HES, SG, RL (n = 32 each) and received 10 ml/kg HES 130/0.4; 10 ml/kg SG (4% modified fluid gelatin) and 20 ml/kg RL respectively prior to SA scheduled for cesarean section. Heart rate, blood pressure (BP), oxygen saturation was measured.
RESULTS


The fall in systolic blood pressure (SBP) (<100 mm Hg) noted among 5 (15.63%), 12 (37.5%) and 14 (43.75%) parturients in groups HES, SG, RL respectively. Vasopressor (phenylephrine) was used to treat hypotension when SBP <90 mm Hg. Both the results and APGAR scores were comparable in all the groups. Lower preloading volume and less intra-operative vasopressor requirement was noted in HES group for maintaining BP though it has no clinical significance.
CONCLUSION


RL which is cheap, physiological and widely available crystalloid can preload effectively and maintain hemodynamic stability well in cesarean section and any remnant hypotension can easily be manageable with vasopressor.",2014,"The fall in systolic blood pressure (SBP) (<100 mm Hg) noted among 5 (15.63%), 12 (37.5%) and 14 (43.75%) parturients in groups HES, SG, RL respectively.","['Ninety six ASA', 'altered hemodynamics after spinal anesthesia', 'patients undergoing lower segment caesarean section', 'patients undergoing cesarean section under spinal anesthesia', 'I healthy, nonlaboring parturients']","['Vasopressor (phenylephrine', ""Ringer's lactate (RL) or tetrastarch hydroxyethyl starch (HES) or succinylated gelatin (SG"", 'tetrastarch, succinylated gelatin and ringer lactate solution', '10 ml/kg HES 130/0.4; 10 ml/kg SG (4% modified fluid gelatin) and 20 ml/kg RL respectively prior to SA scheduled for cesarean section']","['hemodynamic stability', 'Lower preloading volume and less intra-operative vasopressor requirement', 'systolic blood pressure (SBP', 'Heart rate, blood pressure (BP), oxygen saturation', 'APGAR scores']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section (procedure)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C1816356', 'cui_str': 'Product containing tetrastarch'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0143961', 'cui_str': 'succinylated gelatin'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0128811', 'cui_str': 'modified fluid gelatins'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",96.0,0.0698988,"The fall in systolic blood pressure (SBP) (<100 mm Hg) noted among 5 (15.63%), 12 (37.5%) and 14 (43.75%) parturients in groups HES, SG, RL respectively.","[{'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Bangur Institute of Neurology, Kolkata, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Rahul Deb', 'Initials': 'RD', 'LastName': 'Mandal', 'Affiliation': 'Department G and O, Burdwan Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Bimal Kumar', 'Initials': 'BK', 'LastName': 'Hajra', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.140817']
971,25191189,"Pain relief in day care arthroscopic knee surgery: A comparison between intra-articular ropivacaine and levobupivacaine: A prospective, double-blinded, randomized controlled study.","BACKGROUND


Post-operative pain frequently hampers implementation of day care arthroscopic knee surgery in spite of so many analgesic, local anesthetic drugs and routes of administration.
AIMS


The aim of the present study was carried out to compare the efficacy of ropivacaine and levobupivacaine when administered through intra-articular route in controlling pain after day care arthroscopic knee surgery.
SETTING AND DESIGN


It was a prospective, double-blinded and randomized controlled study.
MATERIALS AND METHODS


April 2008-December 2008, 60 patients of both sex, of American Society of Anesthesiologists physical status I and II, undergoing day care arthroscopic knee surgery were randomly assigned into two groups (R, L). Group R received 10 ml of 0.75% ropivacaine, whereas group L received 10 ml of 0.50% levobupivacaine through intra-articular route at the end of the procedure. Pain assessed using visual analog scale (VAS) and diclofenac sodium given as rescue analgesia when VAS >3. Time of first analgesic request and total rescue analgesic were calculated.
STATISTICAL ANALYSIS AND RESULTS


based on comparable demographic profiles; time for the requirement of first post-operative rescue analgesia (242.16 ± 23.86 vs. 366.62 ± 24.42) min and total mean rescue analgesic requirement was (104.35 ± 18.96 vs. 76.82 ± 14.28) mg in group R and L respectively. Group R had higher mean VAS score throughout the study period. No side effects found among the groups. These two results were clinically and statistically significant (P < 0.05).
CONCLUSION


Hence, it was evident that intra-articular levobupivacaine give better post-operative pain relief, with an increase in time of first analgesic request and decreased need of total post-operative analgesia compared with ropivacaine.",2014,No side effects found among the groups.,"['controlling pain after day care arthroscopic knee surgery', 'April 2008-December 2008, 60 patients of both sex, of American Society of Anesthesiologists physical status I and II, undergoing day care arthroscopic knee surgery', 'day care arthroscopic knee surgery']","['ropivacaine', 'levobupivacaine', 'diclofenac sodium', 'ropivacaine and levobupivacaine']","['Pain assessed using visual analog scale (VAS', 'Pain relief', 'total mean rescue analgesic requirement', 'time of first analgesic request and decreased need of total post-operative analgesia', 'Time of first analgesic request and total rescue analgesic', 'mean VAS score']","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0873129,No side effects found among the groups.,"[{'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Anaesthesiology, College of Medicine & Sagore Dutta Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Ratul', 'Initials': 'R', 'LastName': 'Kundu', 'Affiliation': 'Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.'}, {'ForeName': 'Tapobrata', 'Initials': 'T', 'LastName': 'Mitra', 'Affiliation': 'Department of Anaesthesiology, Bangur Institute of Neurology, Kolkata, West Bengal, India.'}, {'ForeName': 'Anindya', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Bimal Kumar', 'Initials': 'BK', 'LastName': 'Hajra', 'Affiliation': 'Department of Anaesthesiology, NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Soumyadip', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'Department of G & O, College of Medicine & Sagore Dutta Hospital, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.136435']
972,24665236,"PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study.","BACKGROUND


postoperative nausea and vomiting (PONV) frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens.
AIMS


the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery.
SETTING AND DESIGN


it was a prospective, double blinded, and randomized controlled study.
METHODS


124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62) receiving (IV) Ondansetron (4 mg)] and Group B [(n=62) receiving IV Ramosetron (0.3 mg)] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6, 12, and 18 h postoperatively.
STATISTICAL ANALYSIS AND RESULTS


statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity.
CONCLUSION


it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg) has better efficacy than single dose IV Ondansetron (4 mg) in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.",2014,"statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity.
","['Ambulatory surgery', 'patients undergoing day-care surgery under general anesthesia', '124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery']","['Ramosetron', 'PONV', 'IV Ramosetron', 'Ondansetron', 'Ramosetron and Ondansetron']","['episodes of PONV', 'Episodes of PONV']","[{'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0526950', 'cui_str': 'ramosetron'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",124.0,0.239984,"statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity.
","[{'ForeName': 'Debasis', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': 'Department of Anaesthesiology, MNC and H, Berhampur, West Bengal, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'C.M.S.D.H, Kolkata, West Bengal, India.'}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Rahul Deb', 'Initials': 'RD', 'LastName': 'Mandal', 'Affiliation': 'Department of G and O, Burdwan Medical College, Burdwan, West Bengal, India.'}, {'ForeName': 'Soumyadip', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Orthopedics, R.G. Kar Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Anindya', 'Initials': 'A', 'LastName': 'Mukherjee', 'Affiliation': 'NRS Medical College, Kolkata, West Bengal, India.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Chakraborty', 'Affiliation': 'C.M.S.D.H, Kolkata, West Bengal, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Chattopadhyay', 'Affiliation': 'C.M.S.D.H, Kolkata, West Bengal, India.'}]",Saudi journal of anaesthesia,['10.4103/1658-354X.125917']
973,31811151,Development and implementation of a nurse-led allergy clinic model in primary care: feasibility trial protocol.,"In the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6-12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.",2019,Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.,"['250 participants referred to the nurse-led allergy clinic', 'primary care']",[],"['establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures', 'acceptability of the new service to participants/carers and healthcare professionals', 'retention and quality of life']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3810819', 'cui_str': 'Allergy clinic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}]",250.0,0.13893,Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.,"[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kelman', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hammersley', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK. vicky.hammersley@ed.ac.uk.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Kendall', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Mome', 'Initials': 'M', 'LastName': 'Mukherjee', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morrice', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Harley', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schwarze', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-019-0155-5']
974,24135556,Achilles tendinopathy management: A pilot randomised controlled trial comparing platelet-richplasma injection with an eccentric loading programme.,"OBJECTIVES


To conduct a pilot randomised controlled trial to evaluate the feasibility of conducting a larger trial to evaluate the difference in Victorian Institute of Sports Assessment-Achilles (VISA-A) scores at six months between patients with Achilles tendinopathy treated with a platelet-rich plasma (PRP) injection compared with an eccentric loading programme.
METHODS


Two groups of patients with mid-substance Achilles tendinopathy were randomised to receive a PRP injection or an eccentric loading programme. A total of 20 patients were randomised, with a mean age of 49 years (35 to 66). All outcome measures were recorded at baseline, six weeks, three months and six months.
RESULTS


The mean VISA-A score for the injection group at the primary endpoint of six months was 76.0 (95% confidence interval (CI) 58.3 to 93.7) and for the exercise group was 57.4 (95% CI 38.1 to 76.7). There was no statistically significant difference between these scores (p = 0.171), which was expected from such a pilot study.
CONCLUSIONS


This pilot study has been key to providing data to inform a larger study and shows that the methodology is feasible. Cite this article: Bone Joint Res 2013;2:227-32.",2013,"There was no statistically significant difference between these scores (p = 0.171), which was expected from such a pilot study.
","['Achilles tendinopathy management', 'Two groups of patients with mid-substance Achilles tendinopathy', '20 patients were randomised, with a mean age of 49 years (35 to 66']","['PRP injection or an eccentric loading programme', 'platelet-rich plasma (PRP) injection', 'Sports Assessment-Achilles', 'platelet-richplasma injection with an eccentric loading programme']",['mean VISA-A score'],"[{'cui': 'C1568272', 'cui_str': 'Tendinopathy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C3840085', 'cui_str': 'Disorder of Achilles tendon (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.134063,"There was no statistically significant difference between these scores (p = 0.171), which was expected from such a pilot study.
","[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Kearney', 'Affiliation': 'University of Warwick, WarwickMedical School, Coventry CV2 2DX, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': ''}]",Bone & joint research,['10.1302/2046-3758.210.2000200']
975,23983090,Transcutaneous electrical nerve stimulation as an adjunct to education and exercise for knee osteoarthritis: a randomized controlled trial.,"OBJECTIVE


To determine the additional effects of transcutaneous electrical nerve stimulation (TENS) for knee osteoarthritis (OA) when combined with a group education and exercise program (knee group).
METHODS


The study was a randomized, sham-controlled clinical trial. Patients referred for physiotherapy with suspected knee OA (confirmed using the American College of Rheumatology clinical criteria) were invited. Exclusion criteria included comorbidities preventing exercise, previous TENS experience, and TENS contraindications. Prospective sample size calculations required 67 participants in each trial arm. A total of 224 participants (mean age 61 years, 37% men) were randomized to 3 arms: TENS and knee group (n = 73), sham TENS and knee group (n = 74), and knee group (n = 77). All patients entered an evidence-based 6-week group education and exercise program (knee group). Active TENS produced a ""strong but comfortable"" paraesthesia within the painful area and was used as much as needed during the 6-week period. Sham TENS used dummy devices with no electrical output. Blinded assessment took place at baseline and 3, 6, 12, and 24 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale at 6 weeks. Secondary outcomes included WOMAC pain, stiffness, and total scores; extensor muscle torque; global assessment of change; exercise adherence; and exercise self-efficacy. Data analysis was by intent to treat.
RESULTS


All outcomes improved over time (P < 0.05), but there were no differences between trial arms (P > 0.05). All improvements were maintained at 24-week followup.
CONCLUSION


There were no additional benefits of TENS, failing to support its use as a treatment adjunct within this context.",2014,"All outcomes improved over time (P < 0.05), but there were no differences between trial arms (P > 0.05).","['Patients referred for physiotherapy with suspected knee OA (confirmed using the American College of Rheumatology clinical criteria) were invited', '224 participants (mean age 61 years, 37% men', 'knee osteoarthritis', 'knee osteoarthritis (OA', '67 participants in each trial arm', 'All patients entered an evidence-based 6-week group education and exercise program (knee group']","['sham TENS and knee group', 'Transcutaneous electrical nerve stimulation', 'TENS and knee group', 'transcutaneous electrical nerve stimulation (TENS', 'TENS']","['WOMAC pain, stiffness, and total scores; extensor muscle torque; global assessment of change; exercise adherence; and exercise self-efficacy', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150375', 'cui_str': 'Group instruction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0031843', 'cui_str': 'function'}]",224.0,0.119045,"All outcomes improved over time (P < 0.05), but there were no differences between trial arms (P > 0.05).","[{'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'University of the West of England, Bristol, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Domaille', 'Affiliation': ''}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kirwan', 'Affiliation': ''}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'Johnson', 'Affiliation': ''}]",Arthritis care & research,['10.1002/acr.22147']
976,24117487,"Relationship between plasma, atrial and ventricular perhexiline concentrations in humans: insights into factors affecting myocardial uptake.","AIM


Little is known regarding the steady-state uptake of drugs into the human myocardium. Perhexiline is a prophylactic anti-anginal drug which is increasingly also used in the treatment of heart failure and hypertrophic cardiomyopathy. We explored the relationship between plasma perhexiline concentrations and its uptake into the myocardium.
METHODS


Blood, right atrium ± left ventricle biopsies were obtained from patients treated with perhexiline for a median of 8.5 days before undergoing coronary surgery in the perhexiline arm of a randomized controlled trial. Perhexiline concentrations in plasma and heart tissue were determined by HPLC.
RESULTS


Atrial biopsies were obtained from 94 patients and ventricular biopsies from 28 patients. The median plasma perhexiline concentration was within the therapeutic range at 0.24 mg l⁻¹ (IQR 0.12-0.44), the median atrial concentration was 6.02  mg kg⁻¹ (IQR 2.70-9.06) and median ventricular concentration was 10.0 mg kg⁻¹ (IQR 5.76-13.1). Atrial (r² = 0.76) and ventricular (r² = 0.73) perhexiline concentrations were closely and directly correlated with plasma concentrations (both P < 0.001). The median atrial : plasma ratio was 21.5 (IQR 18.1-27.1), ventricular : plasma ratio was 34.9 (IQR 24.5-55.2) and ventricular : atrial ratio was 1.67 (IQR 1.39-2.22). Using multiple regression, the best model for predicting steady-state atrial concentration included plasma perhexiline, heart rate and age (r² = 0.83). Ventricular concentrations were directly correlated with plasma perhexiline concentration and length of therapy (r² = 0.84).
CONCLUSIONS


This study demonstrates that plasma perhexiline concentrations are predictive of myocardial drug concentrations, a major determinant of drug effect. However, net myocardial perhexiline uptake is significantly modulated by patient age, potentially via alteration of myocardial:extracardiac drug uptake.",2014,"Ventricular concentrations were directly correlated with plasma perhexiline concentration and length of therapy (r² = 0.84).
","['94 patients and ventricular biopsies from 28 patients', 'humans']","['Perhexiline', 'perhexiline']","['median ventricular concentration', 'Ventricular concentrations', 'median plasma perhexiline concentration', 'plasma concentrations', 'median atrial concentration', 'ventricular\u2009:\u2009plasma ratio', 'Perhexiline concentrations in plasma and heart tissue', 'median atrial\u2009:\u2009plasma ratio', 'net myocardial perhexiline uptake']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0031013', 'cui_str': 'Perhexiline'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031013', 'cui_str': 'Perhexiline'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1272575', 'cui_str': 'Heart tissue'}]",94.0,0.046574,"Ventricular concentrations were directly correlated with plasma perhexiline concentration and length of therapy (r² = 0.84).
","[{'ForeName': 'Nigel E', 'Initials': 'NE', 'LastName': 'Drury', 'Affiliation': 'Departments of Clinical Pharmacology and Cardiology, Basil Hetzel Institute, The Queen Elizabeth Hospital, Woodville, SA, Australia; The Discipline of Surgery, University of Adelaide, Adelaide, SA, Australia; Department of Cardiothoracic Surgery, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Licari', 'Affiliation': ''}, {'ForeName': 'Cher-Rin', 'Initials': 'CR', 'LastName': 'Chong', 'Affiliation': ''}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Howell', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Frenneaux', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Pagano', 'Affiliation': ''}, {'ForeName': 'Benedetta C', 'Initials': 'BC', 'LastName': 'Sallustio', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/bcp.12254']
977,23981710,Study protocol: cluster randomised controlled trial to assess the clinical and cost effectiveness of a staff training intervention in inpatient mental health rehabilitation units in increasing service users' engagement in activities.,"BACKGROUND


This study focuses on people with complex and severe mental health problems who require inpatient rehabilitation. The majority have a diagnosis of schizophrenia whose recovery has been delayed due to non-response to first-line treatments, cognitive impairment, negative symptoms and co-existing problems such as substance misuse. These problems contribute to major impairments in social and everyday functioning necessitating lengthy admissions and high support needs on discharge to the community. Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this.
METHODS/DESIGN


This study aims to investigate the clinical and cost-effectiveness of a staff training intervention to increase service users' engagement in activities. This is a single-blind, two-arm cluster randomised controlled trial involving 40 inpatient mental health rehabilitation units across England. Units are randomised on an equal basis to receive either standard care or a ""hands-on"", manualised staff training programme comprising three distinct phases (predisposing, enabling and reinforcing) delivered by a small team of psychiatrists, occupational therapists, service users and activity workers. The primary outcome is service user engagement in activities 12 months after randomisation, assessed using a standardised measure. Secondary outcomes include social functioning and costs and cost-effectiveness of care.
DISCUSSION


The study will provide much needed evidence for a practical staff training intervention that has potential to improve service user functioning, reducing the need for hospital treatment and supporting successful community discharge. The trial is registered with Current Controlled Trials (Ref ISRCTN25898179).",2013,"Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this.
","['40 inpatient mental health rehabilitation units across England', 'people with complex and severe mental health problems who require inpatient rehabilitation', ""inpatient mental health rehabilitation units in increasing service users' engagement in activities""]","['standard care or a ""hands-on"", manualised staff training programme', 'staff training intervention']","['social functioning and costs and cost-effectiveness of care', 'service user engagement in activities 12\xa0months after randomisation, assessed using a standardised measure']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0204512', 'cui_str': 'Mental Health Rehabilitation'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",40.0,0.149964,"Engagement in structured activities reduces negative symptoms of psychosis and may lead to improvement in function, but no trials have been conducted to test the efficacy of interventions that aim to achieve this.
","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Killaspy', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Mundy', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Holloway', 'Affiliation': ''}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Leavey', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ''}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Koeser', 'Affiliation': ''}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Arbuthnott', 'Affiliation': ''}, {'ForeName': 'Rumana Z', 'Initials': 'RZ', 'LastName': 'Omar', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ''}]",BMC psychiatry,['10.1186/1471-244X-13-216']
978,23798616,N0539 phase II trial of fulvestrant and bevacizumab in patients with metastatic breast cancer previously treated with an aromatase inhibitor: a North Central Cancer Treatment Group (now Alliance) trial.,"BACKGROUND


Based on preclinical studies, the vascular endothelial pathway is an important mechanism for estrogen receptor resistance. We conducted a phase II study of fulvestrant and bevacizumab in patients with aromatase inhibitor pretreated metastatic breast cancer.
PATIENTS AND METHODS


A single-stage phase II study was conducted with these objectives: 6-month progression-free survival (PFS), tumor response, toxic effect, and overall survival. Regimen: 250 mg fulvestrant days 1 and 15 (cycle 1) then day 1 (cycle 2 and beyond) and 10 mg/kg bevacizumab days 1 and 15 of each 4-week cycle.
RESULTS


At interim analysis, 20 eligible patients initiated treatment, 11 were progression free and on treatment at 3 months, not meeting the protocol-specified efficacy requirements (at least 12 of 20). Accrual remained open during interim analysis with 36 patients enrolling before final study closure. Among the 33 eligible patients, the median PFS was 6.2 months [95% confidence interval (CI) 3.6-10.1 months]. Of the 18 with measurable disease, 4 (22%) patients (95% CI 6% to 48%) had a confirmed tumor response (1 complete, 3 partial). The most common grade 3/4 adverse events were hypertension 3 (9%) and headache 3 (9%).
CONCLUSIONS


The fulvestrant/bevacizumab combination is safe and tolerable; however, it did not meet its statistical end point.",2013,"The most common grade 3/4 adverse events were hypertension 3 (9%) and headache 3 (9%).
","['20 eligible patients initiated treatment, 11 were progression free and on treatment at 3 months, not meeting the protocol-specified efficacy requirements (at least 12 of 20', 'patients with metastatic breast cancer previously treated with an', 'patients with aromatase inhibitor pretreated metastatic breast cancer', '36 patients enrolling before final study closure']","['fulvestrant/bevacizumab', 'fulvestrant and bevacizumab', 'bevacizumab', 'aromatase inhibitor']","['median PFS', '6-month progression-free survival (PFS), tumor response, toxic effect, and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",20.0,0.0958986,"The most common grade 3/4 adverse events were hypertension 3 (9%) and headache 3 (9%).
","[{'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Tan', 'Affiliation': 'Division of Hematology/Oncology, Mayo Clinic, Jacksonville.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Section of Biostatistics, Mayo Clinic, Scottsdale.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Flynn', 'Affiliation': 'Metro Minnesota CCOP, St Louis Park.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Steen', 'Affiliation': 'Sanford Medical Center, Fargo.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'Metro Minnesota CCOP, St Louis Park.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rowland', 'Affiliation': 'Carle Cancer Center, Urbana.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Northfelt', 'Affiliation': 'Divison of Hematology/Oncology, Mayo Clinic, Scottsdale, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Division of Hematology/Oncology, Mayo Clinic, Jacksonville. Electronic address: perez.edith@mayo.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt213']
979,32421353,Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection. Randomized Controlled Clinical Trial.,"Rationale:  Pleural infection is frequently encountered in clinical practice and is associated with high morbidity and mortality. Limited evidence exists regarding the optimal treatment. Although both early medical thoracoscopy (MT) and tube thoracostomy with intrapleural instillation of tissue plasminogen activator and human recombinant deoxyribonuclease are acceptable treatments for patients with complicated pleural infection, there is a lack of comparative data for these modes of management. Objectives:  The aim of this study was to compare the safety and efficacy of early MT versus intrapleural fibrinolytic therapy (IPFT) in selected patients with multiloculated pleural infection and empyema. Methods:  This was a prospective multicenter, randomized controlled trial involving patients who underwent MT or IPFT for pleural infection. The primary outcome was the length of hospital stay after either intervention. Secondary outcomes included the total length of hospital stay, treatment failure, 30-day mortality, and adverse events. Results:  Thirty-two patients with pleural infection were included in the study. The median length of stay after an intervention was 4 days in the IPFT arm and 2 days in the MT arm ( P  = 0.026). The total length of hospital stay was 6 days in the IPFT arm and 3.5 days in MT arm ( P  = 0.12). There was no difference in treatment failure, mortality, or adverse events between the treatment groups, and no serious complications related to either intervention were recorded. Conclusions:  When used early in the course of a complicated parapneumonic effusion or empyema, MT is safe and might shorten hospital stays for selected patients as compared with IPFT therapy. A multicenter trial with a larger sample size is needed to confirm these findings.Clinical trial registered with ClinicalTrials.gov (NCT02973139).",2020,"There was no difference in treatment failure, mortality or adverse events between treatment groups, and no serious complications related to either interventions were recorded.
","['patients with complicated pleural infection', 'selected patients with multiloculated pleural infection and empyema', 'Pleural Infection', '32 patients with pleural infection', 'patients who underwent MT or IPFT for pleural infection']","['Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy', 'IPFT therapy', 'Medical thoracoscopy', 'medical thoracoscopy (MT) and tube thoracostomy with intrapleural instillation of tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase', 'early MT versus intrapleural fibrinolytic therapy (IPFT']","['treatment failure, mortality or adverse events', 'median length of stay', 'total length of hospital stay, treatment failure, 30-day mortality and adverse events', 'length of hospital stay', 'safety and efficacy', 'total length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0595451', 'cui_str': 'Intrapleural route'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}]","[{'cui': 'C0595451', 'cui_str': 'Intrapleural route'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0189476', 'cui_str': 'Insertion of pleural tube drain'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1135662', 'cui_str': 'Dornase Alfa'}, {'cui': 'C0011522', 'cui_str': 'Deoxyribonucleases'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",32.0,0.0949974,"There was no difference in treatment failure, mortality or adverse events between treatment groups, and no serious complications related to either interventions were recorded.
","[{'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'Kheir', 'Affiliation': 'Division of Pulmonary Diseases, Critical Care and Environmental Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Thakore', 'Affiliation': 'Division of Pulmonary Diseases, Critical Care and Environmental Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana.'}, {'ForeName': 'Hiren', 'Initials': 'H', 'LastName': 'Mehta', 'Affiliation': 'Division of Pulmonary Diseases and Critical Care, University of Florida Health, Gainesville, Florida; and.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jantz', 'Affiliation': 'Division of Pulmonary Diseases and Critical Care, University of Florida Health, Gainesville, Florida; and.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Parikh', 'Affiliation': 'Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chee', 'Affiliation': 'Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaphle', 'Affiliation': 'Division of Pulmonary Diseases, Critical Care and Environmental Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sisnega', 'Affiliation': 'Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fernandez-Bussy', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Majid', 'Affiliation': 'Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202001-076OC']
980,23628450,Linking abuse and recovery through advocacy: an observational study.,"Aims. High numbers of psychiatric service users experience domestic violence, yet limited interventions exist for these victims. We piloted a domestic violence intervention for community mental health services to explore the feasibility of a future cluster randomized controlled trial. Methods. Quasi-experimental controlled design within five Community Mental Health Teams (three intervention and two control teams). The intervention comprised domestic violence training for clinicians' and referral to domestic violence advocacy for service users. Clinicians' (n = 29) domestic violence knowledge, attitudes and behaviours were assessed before and 6 months post-training. Service users' (n = 34) safety behaviours, unmet needs, quality of life and frequency/severity of abuse were examined at baseline and 3 months follow-up. Process evaluation data were also collected. Results. Clinicians receiving the intervention reported significant improvements in domestic violence knowledge, attitudes and behaviours at follow-up (p < 0.05). Service users receiving the intervention reported significant reductions in violence (p < 0.001) and unmet needs at follow-up (p < 0.05). Conclusions. Interventions comprising domestic violence training for clinicians and referral to domestic violence advocacy may improve responses of psychiatric services. Low rates of identification among teams not receiving training suggest that future trials using service user outcomes are unlikely to be feasible. Therefore, other methods of evaluation are needed.",2014,"Clinicians receiving the intervention reported significant improvements in domestic violence knowledge, attitudes and behaviours at follow-up (p < 0.05).",['High numbers of psychiatric service users experience domestic violence'],"['domestic violence intervention', 'domestic violence training', ""domestic violence training for clinicians' and referral to domestic violence advocacy for service users""]","['violence', 'safety behaviours, unmet needs, quality of life and frequency/severity of abuse', 'domestic violence knowledge, attitudes and behaviours']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0206073', 'cui_str': 'Domestic Violence'}]","[{'cui': 'C0206073', 'cui_str': 'Domestic Violence'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0034380'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0206073', 'cui_str': 'Domestic Violence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0582063,"Clinicians receiving the intervention reported significant improvements in domestic violence knowledge, attitudes and behaviours at follow-up (p < 0.05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Trevillion', 'Affiliation': ""Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, King's College, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Centre for the Economics of Mental and Physical Health, Health Service and Population Research Department, Institute of Psychiatry, King's College, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cary', 'Affiliation': ""Centre for the Economics of Mental and Physical Health, Health Service and Population Research Department, Institute of Psychiatry, King's College, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rose', 'Affiliation': ""Service User Research Enterprise, Health Service and Population Research Department, Institute of Psychiatry, King's College, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Oram', 'Affiliation': ""Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, King's College, London, UK.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Feder', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Agnew-Davies', 'Affiliation': 'Domestic Violence Training Ltd, Surbiton, Surrey, UK.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Howard', 'Affiliation': ""Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, King's College, London, UK.""}]",Epidemiology and psychiatric sciences,['10.1017/S2045796013000206']
981,23425543,Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design.,"AIMS


Primary percutaneous coronary intervention (PPCI) is the preferred strategy for acute ST-segment elevation myocardial infarction (STEMI), with evidence of improved clinical outcomes compared to fibrinolytic therapy. However, there is no consensus on how best to manage multivessel coronary disease detected at the time of PPCI, with little robust data on best management of angiographically significant stenoses detected in non-infarct-related (N-IRA) coronary arteries. CVLPRIT will determine the optimal management of N-IRA lesions detected during PPCI.
METHODS AND RESULTS


CVLPRIT (Complete Versus culprit-Lesion only PRimary PCI Trial) is an open-label, prospective, randomised, multicentre trial. STEMI patients undergo verbal ""assent"" on presentation. Patients are included when angiographic MVD has been detected, and randomised to culprit (IRA)-only PCI (n=150) or in-patient complete multivessel PCI (n=150). Cumulative major adverse cardiac events (MACE) - all-cause mortality, recurrent MI, heart failure, need for revascularisation (PCI or CABG) will be recorded at 12 months. Secondary endpoints include safety endpoints of confirmed ischaemic stroke, intracranial haemorrhage, major non-intracranial bleeding, and repair of vascular complications. A cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage index and microvascular obstruction. A cost efficacy analysis will be undertaken.
CONCLUSIONS


The management of multivessel coronary artery disease in the setting of PPCI for STEMI, including the timing of when to perform non-culprit-artery revascularisation if undertaken, remains unresolved. CVLPRIT will yield mechanistic insights into the myocardial consequence of N-IRA intervention undertaken during the peri-infarct period.",2013,"Secondary endpoints include safety endpoints of confirmed ischaemic stroke, intracranial haemorrhage, major non-intracranial bleeding, and repair of vascular complications.",[],"['CVLPRIT', 'percutaneous coronary intervention (PPCI']","['Cumulative major adverse cardiac events (MACE) - all-cause mortality, recurrent MI, heart failure, need for revascularisation (PCI or CABG', 'safety endpoints of confirmed ischaemic stroke, intracranial haemorrhage, major non-intracranial bleeding, and repair of vascular complications']",[],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.103857,"Secondary endpoints include safety endpoints of confirmed ischaemic stroke, intracranial haemorrhage, major non-intracranial bleeding, and repair of vascular complications.","[{'ForeName': 'Damian J', 'Initials': 'DJ', 'LastName': 'Kelly', 'Affiliation': 'Department of Cardiology, University Hospitals of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Gerald P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Blackman', 'Affiliation': ''}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Curzen', 'Affiliation': ''}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': ''}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Fairbrother', 'Affiliation': ''}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Shipley', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kelion', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heatherington', 'Affiliation': ''}, {'ForeName': 'Jamal N', 'Initials': 'JN', 'LastName': 'Khan', 'Affiliation': ''}, {'ForeName': 'Sheraz', 'Initials': 'S', 'LastName': 'Nazir', 'Affiliation': ''}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Alahmar', 'Affiliation': ''}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Flather', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Swanton', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gunning', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Gershlick', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJV8I10A183']
982,23550096,The safety and efficacy of intracoronary nitrite infusion during acute myocardial infarction (NITRITE-AMI): study protocol of a randomised controlled trial.,"INTRODUCTION


Acute myocardial infarction (AMI) is a major cause of death and disability in the UK and worldwide. Presently, timely and effective reperfusion with primary percutaneous coronary intervention (PPCI) remains the most effective treatment strategy for limiting infarct size, preserving left ventricular ejection fraction (LVEF) and improving clinical outcomes. However, the process of reperfusion can itself induce cardiomyocyte death, known as myocardial reperfusion injury, for which there is currently no effective therapy. Extensive preclinical evidence exists to suggest that sodium nitrite (as a source of endogenous nitric oxide) is an effective therapeutic strategy for preventing myocardial reperfusion injury. The purpose of NITRITE-AMI is to test whether sodium nitrite reduces reperfusion injury and subsequent infarct size in patients undergoing PPCI for MI.
METHODS AND DESIGN


NITRITE-AMI is a double-blind, randomised, single-centre, placebo-controlled trial to determine whether intracoronary nitrite injection reduces infarct size in patients with myocardial infarction undergoing primary angioplasty. The study will enrol 80 patients presenting with ST-elevation myocardial infarction. Patients will be randomised to receive either a bolus of intracoronary sodium nitrite or placebo (sodium chloride) at the time of PPCI. The primary outcome is infarct size assessed by creatine kinase area under the curve (AUC) over 48 h. Secondary endpoints include troponin T AUC and infarct size, LV dimensions and myocardial salvage index assessed by cardiac MR (CMR), markers of platelet reactivity and inflammation, the safety and tolerability of intracoronary nitrite, and 1 year major adverse cardiac events.
ETHICS AND DISSEMINATION


The study is approved by the local ethics committee (NRES Committee London West London: 11/LO/1500) and by the Medicines and Healthcare Products Regulatory Agency (MHRA) (EudraCT nr. 2010-022460-12). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.
TRIAL REGISTRATION


United Kingdom Clinical Research Network (Study ID 12117), http://clinicaltrials.gov (NCT01584453) and Current Controlled Trials (ISRCTN:38736987).",2013,Extensive preclinical evidence exists to suggest that sodium nitrite (as a source of endogenous nitric oxide) is an effective therapeutic strategy for preventing myocardial reperfusion injury.,"['80 patients presenting with ST-elevation myocardial infarction', 'patients undergoing PPCI for MI', 'patients with myocardial infarction undergoing primary angioplasty']","['placebo', 'sodium nitrite', 'intracoronary nitrite injection', 'intracoronary nitrite infusion', 'primary percutaneous coronary intervention (PPCI', 'intracoronary sodium nitrite or placebo (sodium chloride']","['infarct size assessed by creatine kinase area under the curve (AUC', 'safety and efficacy', 'infarct size', 'troponin T AUC and infarct size, LV dimensions and myocardial salvage index assessed by cardiac MR (CMR), markers of platelet reactivity and inflammation, the safety and tolerability of intracoronary nitrite, and 1 year major adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037532', 'cui_str': 'Sodium Nitrite'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",80.0,0.525381,Extensive preclinical evidence exists to suggest that sodium nitrite (as a source of endogenous nitric oxide) is an effective therapeutic strategy for preventing myocardial reperfusion injury.,"[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Jones', 'Affiliation': 'Centre of Clinical Pharmacology, Barts NIHR Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Queen Mary University, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Andiapen', 'Affiliation': ''}, {'ForeName': 'T J A', 'Initials': 'TJ', 'LastName': 'Van-Eijl', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Webb', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Antoniou', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Schilling', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ahluwalia', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2013-002813']
983,23473058,Return to work after traumatic brain injury: cohort comparison and economic evaluation.,"BACKGROUND


Returning to work (RTW) in the UK is problematic following TBI. Vocational rehabilitation (VR) is limited and efficacy or costs seldom reported. This study aimed to determine whether a TBI specialist VR intervention (TBI VR) was more effective at work return and retention 12 months after injury than usual care (UC). Secondary aims were to explore the feasibility of collecting economic data to inform a definitive trial.
METHOD


Work outcomes of TBI-VR were compared to UC. Ninety-four participants (40 TBI-VR) with TBI resulting in hospitalization ≥48 hours, who were working at injury were followed up by postal questionnaire at 3, 6 and 12 months post-hospital discharge. Primary outcome was RTW. Secondary outcomes were functional ability, mood and quality-of-life. Health resource use was measured by self-report.
RESULTS


At 12 months, 15% more TBI-VR participants (27% more with moderate/severe TBI) were working than UC (27/36, 75% vs. 27/45, 60%). Mean TBI-VR health costs per person (consultant, GP, therapy, medication) were only £75 greater at 1 year. Secondary outcomes showed no significant baseline differences between groups.
DISCUSSION


More TBI-VR participants returned to work than UC. People with moderate/severe TBI benefitted most. This positive trend was achieved without greatly increased health costs, suggesting cost-effectiveness. This study justifies the need for and can inform a definitive Randomized Controlled Trial (RCT).",2013,"Mean TBI-VR health costs per person (consultant, GP, therapy, medication) were only £75 greater at 1 year.","['Ninety-four participants (40 TBI-VR) with TBI resulting in hospitalization ≥48 hours, who were working at injury were followed up by postal questionnaire at 3, 6 and 12 months post-hospital discharge', 'People with moderate/severe TBI benefitted most']","['TBI specialist VR intervention (TBI VR', 'Vocational rehabilitation (VR']","['health costs, suggesting cost-effectiveness', 'functional ability, mood and quality-of-life', 'TBI-VR', 'Mean TBI-VR health costs per person (consultant, GP, therapy, medication']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation (regime/therapy)'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",94.0,0.106584,"Mean TBI-VR health costs per person (consultant, GP, therapy, medication) were only £75 greater at 1 year.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Radford', 'Affiliation': 'Rehabilitation Research, University of Nottingham, Nottingham, UK. kate.radford@nottingham.ac.uk'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': ''}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Sach', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Tyerman', 'Affiliation': ''}, {'ForeName': 'Naseer', 'Initials': 'N', 'LastName': 'Haboubi', 'Affiliation': ''}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': ''}]",Brain injury,['10.3109/02699052.2013.766929']
984,23403087,Does adjuvant long-acting gestagen therapy improve the outcome of hysteroscopic endometrial resection in women of low-resource settings with heavy menstrual bleeding?,"OBJECTIVE


To test for the hypothesis of the beneficial effect of long-acting gestagens as an adjuvant postoperative therapy on the outcome of hysteroscopic transcervical endometrial resection (TCRE) in women of low-resource settings and suffering from ovulatory heavy menstrual bleeding (menorrhagia).
DESIGN


Randomized controlled trial (Canadian Task Force classification I).
SETTING


Low-resource tertiary care university hospital.
PATIENTS


Seventy-one premenopausal women with established ovulatory menorrhagia.
INTERVENTION


After randomization, 37 patients were treated with TCRE plus gestagen and 34 patients with TCRE alone.
MEASUREMENTS AND MAIN RESULTS


Variations in menstrual patterns and bleeding scores, as well as amenorrhea and repeat surgery rates with treatment, were determined 1 year after resection. In those who continued to menstruate at 6 months, treatment with TCRE plus gestagen was associated with a significant reduction in the number of days bleeding from 7.2 to 3.4 (p ≤ .0001), increased cycle length from 24 to 30 (p = .02), a 60% reduction in dysmenorrhea score from 62 to 25 (p ≤ .0001), and a 60% reduction in premenstrual syndrome score from 55 to 22 (p = .04). Amenorrhea rates at 12 months in the TCRE plus gestagen and TCRE alone groups were 40% versus 26% (p = .02), with combined amenorrhea and hypomenorrhea rates of 75% versus 64% (p = .02), respectively. At 12 months, repeat surgery rates were higher in the TCRE alone group (21% vs 3%, p < .05).
CONCLUSION


In a low-resource setting, the adjuvant postoperative long-acting gestagen therapy has proven to be superior in inducing amenorrhea after hysteroscopic TCRE.",2013,"At 12 months, repeat surgery rates were higher in the TCRE alone group (21% vs 3%, p < .05).
","['Low-resource tertiary care university hospital', 'women of low-resource settings with heavy menstrual bleeding', '37 patients were treated with TCRE plus gestagen and 34 patients with TCRE alone', 'Seventy-one premenopausal women with established ovulatory menorrhagia', 'women of low-resource settings and suffering from ovulatory heavy menstrual bleeding (menorrhagia']","['TCRE', 'hysteroscopic transcervical endometrial resection (TCRE', 'adjuvant long-acting gestagen therapy']","['cycle length', 'premenstrual syndrome score', 'repeat surgery rates', 'number of days bleeding', 'menstrual patterns and bleeding scores, as well as amenorrhea and repeat surgery rates', 'dysmenorrhea score', 'Amenorrhea rates', 'combined amenorrhea and hypomenorrhea rates', 'hysteroscopic endometrial resection']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}]","[{'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C0404115', 'cui_str': 'Endometrial resection (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0020624', 'cui_str': 'Hypomenorrhea'}, {'cui': 'C0404115', 'cui_str': 'Endometrial resection (procedure)'}]",37.0,0.124851,"At 12 months, repeat surgery rates were higher in the TCRE alone group (21% vs 3%, p < .05).
","[{'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shokeir', 'Affiliation': 'Department of OB/GYN, Mansoura University Hospital, Mansoura Faculty of Medicine, Mansoura, Egypt. tarekshokeir1@hotmail.com'}, {'ForeName': 'Mouhamed', 'Initials': 'M', 'LastName': 'Eid', 'Affiliation': ''}, {'ForeName': 'El-Said', 'Initials': 'el-S', 'LastName': 'Abdel-Hady', 'Affiliation': ''}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2012.11.006']
985,31823309,Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial.,"BACKGROUND


Risk communication is a core aspect of a physician's work and a fundamental prerequisite for successful shared decision-making. However, many physicians are not able to adequately communicate risks to patients due to a lack of understanding of statistics as well as inadequate management of conflicts of interest (COI).
OBJECTIVE


To evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants' risk communication competence, that is, their competence to advise patients on the benefits and harms of diagnostic or therapeutic interventions.
DESIGN


A rater-blind randomized controlled trial with a 30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers.
PARTICIPANTS


Sixty-three medical students in their fourth or fifth year.
INTERVENTIONS


Participants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual.
MAIN MEASURES


Primary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE).
KEY RESULTS


Participants were 25.7 years old on average (SD 3.6); 73% (46/63) were female. Increase in risk communication performance was significantly higher in the intervention group with post-intervention Cohen's d of 2.35 (95% confidence interval (CI) 1.62 to 3.01, p < 0.01) and of 1.83 (CI 1.13 to 2.47, p < 0.01) 30 (± 1) weeks later. Secondary outcomes with the exception of frequency of interactions with the pharmaceutical industry also showed relevant improvements in the intervention as compared with the control group (d between 0.91 and 2.04 (p < 0.001)).
CONCLUSIONS


Our results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance. We interpret the large effect sizes to be a result of the integration of topics that are usually taught separately, leading to a more effective organization of knowledge.
TRIAL REGISTRATION


The trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.",2020,Our results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance.,"['Sixty-three medical students in their fourth or fifth year', '30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers', 'Participants were 25.7 years old on average (SD 3.6); 73% (46/63) were female']","['integrated curriculum encompassing COI and shared decision-making', 'Participants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual']","['frequency of interactions with the pharmaceutical industry', 'risk communication performance in a video-observed structured clinical examination (VOSCE', 'risk communication performance']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0013185', 'cui_str': 'Industry, Pharmaceutic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}]",63.0,0.111252,Our results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance.,"[{'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Dreimüller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Janosch', 'Initials': 'J', 'LastName': 'Weißkircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Deis', 'Affiliation': 'Department of Pneumology, Thoraxklinik Heidelberg, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gaitzsch', 'Affiliation': 'Department of Pneumology, Thoraxklinik Heidelberg, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Stoll', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Bäßler', 'Affiliation': 'Department for General Internal and Psychosomatic Medicine, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Lieb', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Jünger', 'Affiliation': 'IMPP - German Institute for Medical and Pharmaceutical Examinations, Postfach 2528, 55015, Mainz, Germany. JJuenger@impp.de.'}]",Journal of general internal medicine,['10.1007/s11606-019-05420-w']
986,22814578,A randomised study evaluating the use of pyridoxine to avoid capecitabine dose modifications.,"BACKGROUND


Pyridoxine is frequently used to treat capecitabine-induced hand-foot syndrome (HFS), although the evidence of benefit is lacking. We performed a randomised placebo-controlled trial to determine whether pyridoxine could avoid the need for capecitabine dose modifications and improve outcomes.
METHODS


A total of 106 patients planned for palliative single-agent capecitabine (53 in each arm, 65%/35% colorectal/breast cancer) were randomised to receive either concomitant pyridoxine (50 mg po) or matching placebo three times daily.
RESULTS


Compared with placebo, pyridoxine use was associated with an increased rate of avoiding capecitabine dose modifications (37% vs 23%, relative risk 0.59, 95% CI 0.29, 1.20, P=0.15) and fewer grade 3/4 HFS-related adverse events (9% vs 17%, odds ratio 0.51, 95% CI 0.15-1.6, P=0.26). Use of pyridoxine did not improve response rate or progression-free survival.
CONCLUSION


Pyridoxine may reduce the need for capecitabine dose modifications and the incidence of severe HFS, but does not impact on antitumour effect.",2012,"Use of pyridoxine did not improve response rate or progression-free survival.
","['53 in each arm, 65%/35% colorectal/breast cancer', 'A total of 106 patients planned for']","['placebo', 'concomitant pyridoxine (50 mg po) or matching placebo three times daily', 'palliative single-agent capecitabine', 'placebo, pyridoxine', 'Pyridoxine', 'pyridoxine']","['grade 3/4 HFS-related adverse events', 'response rate or progression-free survival', 'rate of avoiding capecitabine dose modifications']","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",106.0,0.700389,"Use of pyridoxine did not improve response rate or progression-free survival.
","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""Oncology Division, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK. pippa.corrie@addenbrookes.nhs.uk""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bulusu', 'Affiliation': ''}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Armstrong', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hardy', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lao-Sirieix', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Parashar', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Daniel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blesing', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Moody', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Osborne', 'Affiliation': ''}]",British journal of cancer,['10.1038/bjc.2012.318']
987,31852441,Impact of a semi-structured briefing on the management of adverse events in anesthesiology: a randomized pilot study.,"BACKGROUND


Human factors research has identified mental models as a key component for the effective sharing and organization of knowledge. The challenge lies in the development and application of tools that help team members to arrive at a shared understanding of a situation. The aim of this study was to assess the influence of a semi-structured briefing on the management of a simulated airway emergency.
METHODS


37 interprofessional teams were asked to perform a simulated rapid-sequence induction in the simulator. Teams were presented with a ""cannot ventilate, cannot oxygenate"" scenario that ultimately required a cricothyroidotomy. Study group (SG) teams were asked to perform a briefing prior to induction, while controls (CG) were asked to perform their usual routine.
RESULTS


We observed no difference in the mean time until cricothyroidotomy (SG 8:31 CG 8:16, p = 0.36). There was a significant difference in groups' choice of alternative means of oxygenation: While SG teams primarily chose supraglottic airway devices, controls initially reverted to mask ventilation (p = 0.005). SG teams spent significantly less time with this alternative airway device and were quicker to advance in the airway algorithm.
CONCLUSIONS


Our study addresses effects on team coordination through a shared mental model as effected by a briefing prior to anesthesia induction. We found measurable improvements in airway management during those stages of the difficult airway algorithm explicitly discussed in the briefing. For those, time spent was shorter and participants were quicker to advance in the airway algorithm.",2019,"There was a significant difference in groups' choice of alternative means of oxygenation: While SG teams primarily chose supraglottic airway devices, controls initially reverted to mask ventilation (p = 0.005).","['37 interprofessional teams', 'anesthesiology']",['semi-structured briefing'],"['mean time until cricothyroidotomy', 'adverse events', ' choice of alternative means of oxygenation']","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.021178,"There was a significant difference in groups' choice of alternative means of oxygenation: While SG teams primarily chose supraglottic airway devices, controls initially reverted to mask ventilation (p = 0.005).","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld, 110 69120, Heidelberg, Germany. c.neuhaus@uni-heidelberg.de.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schäfer', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld, 110 69120, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld, 110 69120, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lichtenstern', 'Affiliation': 'Department of Anesthesiology, Heidelberg University Hospital, Im Neuenheimer Feld, 110 69120, Heidelberg, Germany.'}]",BMC anesthesiology,['10.1186/s12871-019-0913-5']
988,31842771,Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study.,"BACKGROUND


Topical anaesthesia is important to optimize pain control during dental injection. Our aim was to describe a new simple method for topical anaesthesia of oral mucosa and to compare the effectiveness of ice and lidocaine 5% gel for topical anaesthesia of oral mucosa.
METHODS


A total of 40 patients aged 10.7-19.5 years were included. The side and method of application were both randomized. Heart rate was recorded, and discomfort and pain were evaluated with a visual analogue scale (VAS). A paired t-test was used to compare mean values, a chi 2  test was used to compare proportions, and a Pearson correlation test was used to examine correlations between variables.
RESULTS


When ice was used, buccal injection VAS pain was rated lower (p = 0.044), and VAS discomfort was rated higher (p = 0.001), in comparison to when lidocaine 5% gel was used. There was no significant difference in relative heart rate change between ice and lidocaine 5% gel at either needle stick or injection. Lidocaine 5% gel produced a relative heart rate reduction after palatal injection (0.99 ± 0.06) while buccal injection produced an increased relative heart rate (1.02 ± 0.08) (p = 0.010). Unpleasant taste was more frequently reported when lidocaine 5% gel was used (p = 0.025). An application time of 1 min was sufficient for both ice and lidocaine 5% gel to achieve pain reduction from needle stick in buccal mucosa.
CONCLUSION


The cheap and readily available described method using ice for topical anaesthesia of oral mucosa before dental injection is an effective alternative to lidocaine 5% gel.
TRIAL REGISTRATION


The European Union Drug Regulating Authorities Clinical Trials Database EudraCT201300530531. Date of registration: February 10th, 2014.",2019,There was no significant difference in relative heart rate change between ice and lidocaine 5% gel at either needle stick or injection.,['A total of 40 patients aged 10.7-19.5\u2009years were included'],"['lidocaine', 'Lidocaine']","['pain reduction', 'relative heart rate change', 'relative heart rate reduction', 'relative heart rate', 'VAS discomfort', 'Heart rate', 'buccal injection VAS pain', 'visual analogue scale (VAS', 'discomfort and pain', 'Unpleasant taste']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}]",,0.0578561,There was no significant difference in relative heart rate change between ice and lidocaine 5% gel at either needle stick or injection.,"[{'ForeName': 'Nishma', 'Initials': 'N', 'LastName': 'Hindocha', 'Affiliation': 'Department of Ear, Nose, Throat and Maxillofacial Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Manhem', 'Affiliation': 'Public Dental Service Östergötland, Linköping, Region Östergötland, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bäckryd', 'Affiliation': 'Pain and Rehabilitation Center, and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Bågesund', 'Affiliation': 'Centre for Orthodontics and Paediatric Dentistry, Norrköping, Public Dental Service Östergötland, Region Östergötland, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. mats.bagesund@regionostergotland.se.'}]",BMC anesthesiology,['10.1186/s12871-019-0902-8']
989,31852438,Modified technique for thermal radiofrequency ablation of Thoracic dorsal root ganglia under combined fluoroscopy and CT guidance: a randomized clinical trial.,"BACKGROUND


This study is comparing thermal radiofrequency ablation (TRFA) of the thoracic dorsal root ganglia (TDRG) guided by Xper CT and fluoroscopy with the standard fluoroscopy.
METHODS


This randomized clinical trial included 78 patients suffering from chronic refractory pain due to chest malignancies randomly allocated into one of two groups according to guidance of TRFA of TDRG. In CT guided group (n = 40) TRFA was done under integrated Xper CT-scan and fluoroscopy guidance, while it was done under fluoroscopy guidance only in standard group (n = 38). The primary outcome was pain intensity measured by visual analog scale (VAS) score, functional improvement and consumption of analgesics. The secondary outcome measures were patient global impression of changes (PGIC) and adverse effects.
RESULTS


VAS scores decreased in the two groups compared to baseline values (p < 0.001) and were lower in CT guided group up to 12 weeks. Pregabalin and oxycodone consumption was higher in the standard group at 1, 4 and 12 weeks (p < 0.001). Functional improvement showed near significant difference between the two groups (P = 0.06 at week 1, 0.07 at week 4 respectively) while the difference was statistically significant at week 12 (P = 0.04). PGIC showed near significant difference only at week 1 (P = 0.07) while the per-patient adverse events were lower in CT guided group (p = 0.027).
CONCLUSIONS


Integrated modality guidance with Xper CT-scan and fluoroscopy together with suprapedicular inferior transforaminal approach may improve efficacy and safety of TRFA of TDRG for the treatment of intractable chest pain in cancer patients.
TRIAL REGISTRATION


The study was retrospectively registered at clinicaltrials.gov on 04/22/2018 (Registration No.: NCT03533413).",2019,"Functional improvement showed near significant difference between the two groups (P = 0.06 at week 1, 0.07 at week 4 respectively) while the difference was statistically significant at week 12 (P = 0.04).","['78 patients suffering from chronic refractory pain due to chest malignancies', 'cancer patients']","['Modified technique for thermal radiofrequency ablation of Thoracic dorsal root ganglia under combined fluoroscopy and CT guidance', 'thermal radiofrequency ablation (TRFA) of the thoracic dorsal root ganglia (TDRG) guided by Xper CT and fluoroscopy with the standard fluoroscopy', 'TRFA of TDRG', 'TDRG']","['per-patient adverse events', 'Pregabalin and oxycodone consumption', 'patient global impression of changes (PGIC) and adverse effects', 'pain intensity measured by visual analog scale (VAS) score, functional improvement and consumption of analgesics', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0017070', 'cui_str': 'Dorsal Root Ganglia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",78.0,0.118966,"Functional improvement showed near significant difference between the two groups (P = 0.06 at week 1, 0.07 at week 4 respectively) while the difference was statistically significant at week 12 (P = 0.04).","[{'ForeName': 'Raafat M', 'Initials': 'RM', 'LastName': 'Reyad', 'Affiliation': 'Department of Anesthesia & Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hossam Z', 'Initials': 'HZ', 'LastName': 'Ghobrial', 'Affiliation': 'Department of Anesthesia & Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ehab H', 'Initials': 'EH', 'LastName': 'Shaker', 'Affiliation': 'Department of Anesthesia & Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt. ehabhanafy2006@yahoo.com.'}, {'ForeName': 'Ehab M', 'Initials': 'EM', 'LastName': 'Reyad', 'Affiliation': 'Department of Clinical Pathology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.'}, {'ForeName': 'Mohammed H', 'Initials': 'MH', 'LastName': 'Shaaban', 'Affiliation': 'Department of Diagnostic & Interventional Radiology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Rania H', 'Initials': 'RH', 'LastName': 'Hashem', 'Affiliation': 'Department of Diagnostic & Interventional Radiology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Wael M', 'Initials': 'WM', 'LastName': 'Darwish', 'Affiliation': 'Department of Diagnostic & Interventional Radiology, National Cancer Institute, Cairo University, Cairo, Egypt.'}]",BMC anesthesiology,['10.1186/s12871-019-0906-4']
990,31862004,"Effects of different doses of magnesium sulfate on pneumoperitoneum-related hemodynamic changes in patients undergoing gastrointestinal laparoscopy: a randomized, double-blind, controlled trial.","BACKGROUND


The infusion of magnesium sulfate is well known to reduce arterial pressure and attenuate hemodynamic response to pneumoperitoneum. This study aimed to investigate whether different doses of magnesium sulfate can effectively attenuate the pneumoperitoneum-related hemodynamic changes and the release of vasopressin in patients undergoing laparoscopic gastrointestinal surgery.
METHODS


Sixty-nine patients undergoing laparoscopic partial gastrectomy were randomized into three groups: group L received magnesium sulfate 30 mg/kg loading dose and 15 mg/kg/h continuous maintenance infusion for 1 h; group H received magnesium sulfate 50 mg/kg followed by 30 mg/kg/h for 1 h; and group S (control group) received same volume 0.9% saline infusion, immediately before the induction of pneumoperitoneum. Systemic vascular resistance (SVR), cardiac output (CO), mean arterial pressure (MAP), heart rate (HR), central venous pressure (CVP), serum vasopressin and magnesium concentrations were measured. The extubation time, visual analogue scale were also assessed. The primary outcome is the difference in SVR between different groups. The secondary outcome is the differences of other indicators between groups, such as CO, MAP, HR, CVP, vasopressin and postoperative pain score.
RESULTS


Pneumoperitoneum instantly resulted in a significant reduction of cardiac output and an increase in mean arterial pressure, systemic vascular resistance, central venous pressure and heart rate in the control group (P <  0.01). The mean arterial pressure (T2 - T4) ,  systemic vascular resistance (T2 - T3), central venous pressure(T3-T5) and the level of serum vasopressin were significantly lower (P <  0.05) and the cardiac output (T2 - T3) was significantly higher (P <  0.05) in group H than those in the control group. The mean arterial pressure (T4), systemic vascular resistance (T2), and central venous pressure(T3-T4) were significantly lower in group H than those in group L (P <  0.05). Furthermore, the visual analog scales at 5 min and 20 min, the level of vasopressin, and the dose of remifentanil were significantly decreased in group H compared to the control group and group L (P <  0.01).
CONCLUSION


Magnesium sulfate could safely and effectively attenuate the pneumoperitoneum-related hemodynamic instability during gastrointestinal laparoscopy and improve postoperative pain at serum magnesium concentrations above 2 mmol/L.
TRIAL REGISTRATION


The study was retrospectively registered at Chinese Clinical Trial Registry; the registration number is ChiCTR-IPD-17011145, principal investigator: D.Y. Q., date of registration: April 13, 2017.",2019,"RESULTS


Pneumoperitoneum instantly resulted in a significant reduction of cardiac output and an increase in mean arterial pressure, systemic vascular resistance, central venous pressure and heart rate in the control group (P <  0.01).","['patients undergoing gastrointestinal laparoscopy', 'patients undergoing laparoscopic gastrointestinal surgery', 'Sixty-nine patients undergoing laparoscopic partial gastrectomy']","['Magnesium sulfate', 'magnesium sulfate 30\u2009mg/kg loading dose and 15\u2009mg/kg/h continuous maintenance infusion for 1\u2009h; group H received magnesium sulfate 50\u2009mg/kg followed by 30\u2009mg/kg/h for 1\u2009h; and group S (control group) received same volume 0.9% saline infusion', 'magnesium sulfate']","['mean arterial pressure (T2 - T4) ,  systemic vascular resistance (T2 - T3), central venous pressure(T3-T5) and the level of serum vasopressin', 'extubation time, visual analogue scale', 'CO, MAP, HR, CVP, vasopressin and postoperative pain score', 'mean arterial pressure (T4), systemic vascular resistance (T2), and central venous pressure(T3-T4', 'visual analog scales', 'postoperative pain at serum magnesium concentrations', 'SVR', 'cardiac output', 'mean arterial pressure, systemic vascular resistance, central venous pressure and heart rate', 'Systemic vascular resistance (SVR), cardiac output (CO), mean arterial pressure (MAP), heart rate (HR), central venous pressure (CVP), serum vasopressin and magnesium concentrations', 'level of vasopressin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0030600', 'cui_str': 'Subtotal gastrectomy (procedure)'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0441842', 'cui_str': 'Group H (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0441853', 'cui_str': 'Group S (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0444466', 'cui_str': 'Central venous (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]",69.0,0.46192,"RESULTS


Pneumoperitoneum instantly resulted in a significant reduction of cardiac output and an increase in mean arterial pressure, systemic vascular resistance, central venous pressure and heart rate in the control group (P <  0.01).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, Yancheng Third people's Hospital, Yancheng, China.""}, {'ForeName': 'Dong-Chen', 'Initials': 'DC', 'LastName': 'Qian', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Meng-Meng', 'Initials': 'MM', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Dun-Yi', 'Initials': 'DY', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. qdy6808@163.com.'}]",BMC anesthesiology,['10.1186/s12871-019-0886-4']
991,31728894,PreView: a Randomized Trial of a Multi-site Intervention in Diverse Primary Care to Increase Rates of Age-Appropriate Cancer Screening.,"BACKGROUND


Women aged 50-70 should receive breast, cervical (until age 65), and colorectal cancer (CRC) screening; men aged 50-70 should receive CRC screening and should discuss prostate cancer screening (PSA). PreView, an interactive, individually tailored Video Doctor Plus Provider Alert Intervention, adresses all cancers for which average risk 50-70-year-old individuals are due for screening or screening discussion.
METHODS


We conducted a randomized controlled trial in 6 clinical sites. Participants were randomized to PreView or a video about healthy lifestyle. Intervention group participants completed PreView before their appointment and their clinicians received a ""Provider Alert."" Primary outcomes were receipt of mammography, Pap tests (with or without HPV testing), CRC screening (FIT in last year or colonoscopy in last 10 years), and PSA screening discussion. Additional outcomes included breast, cervical, and CRC screening discussion.
RESULTS


A total of 508 individuals participated, 257 in the control group and 251 in the intervention group. Screening rates were relatively high at baseline. Compared with baseline screening rates, there was no significant increase in mammography or Pap smear screening, and a nonsignificant increase (18% vs 12%) in CRC screening. Intervention participants reported a higher rate of PSA discussion than did control participants (58% vs 36%: P < 0.01). Similar increases were seen in discussions about mammography, cervical cancer, and CRC screening.
CONCLUSION


In clinics with relatively high overall screening rates at baseline, PreView did not result in significant increases in breast, cervical, or CRC screening. PreView led to an increase in PSA screening discussion. Clinician-patient discussion of all cancer screenings significantly increased, suggesting that interventions like PreView may be most useful when discussion of the pros and cons of screening is recommended and/or with patients reluctant to undergo screening. Future research should investigate PreView's impact on those who are hesitant or reluctant to undergo screening.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02264782.",2020,Intervention participants reported a higher rate of PSA discussion than did control participants (58% vs 36%: P < 0.01).,"['Women aged 50-70 should receive breast, cervical (until age 65), and colorectal cancer (CRC) screening; men aged 50-70 should receive', '508 individuals participated, 257 in the control group and 251 in the intervention group']","['Multi-site Intervention', 'PreView or a video about healthy lifestyle', 'Provider Alert', 'CRC screening and should discuss prostate cancer screening (PSA']","['receipt of mammography, Pap tests (with or without HPV testing), CRC screening (FIT in last year or colonoscopy in last 10 years), and PSA screening discussion', 'breast, cervical, and CRC screening discussion', 'higher rate of PSA discussion', 'discussions about mammography, cervical cancer, and CRC screening', 'PSA screening discussion', 'breast, cervical, or CRC screening', 'mammography or Pap smear screening', 'Screening rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C3541459', 'cui_str': 'Papanicolaou Smear'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0079104', 'cui_str': 'Cervical Smears'}]",508.0,0.148299,Intervention participants reported a higher rate of PSA discussion than did control participants (58% vs 36%: P < 0.01).,"[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA. judith.walsh@ucsf.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Potter', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Salazar', 'Affiliation': 'Department of Medical Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Gildengorin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Dass', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Helen Diller Comprehensive Cancer Center and Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05438-0']
992,22545990,A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study.,"BACKGROUND


Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff) are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability.Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise) in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance.
METHODS/DESIGN


A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist's.An economic analysis will be conducted from an NHS and Personal Social Services perspective to evaluate cost-effectiveness and a qualitative investigation will be undertaken to develop greater understanding of the experience of undertaking or prescribing exercise as a self-managed therapy.
TRIAL REGISTRATION NUMBER


ISRCTN84709751.",2012,A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy.,"['210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a', 'Disorders of the shoulder muscles and tendons (rotator cuff', 'chronic rotator cuff disorders']","['programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes', 'usual physiotherapy', 'exercise against gravity or resistance (loaded exercise', 'self-managed exercise programme', 'self-managed loaded exercise programme versus usual clinic based physiotherapy']","['Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36', 'shoulder pain, function and quality of life']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0687023', 'cui_str': 'Structure of skeletal muscle of shoulder'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C1261286', 'cui_str': 'Opaque (qualifier value)'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}]",210.0,0.115907,A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy.,"[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Littlewood', 'Affiliation': 'School of Health & Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. c.littlewood@sheffield.ac.uk'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ashton', 'Affiliation': ''}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Mawson', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'May', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Walters', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/1471-2474-13-62']
993,22459731,Development and preliminary evaluation of a psychosocial intervention for modifying psychosocial risk factors associated with foot re-ulceration in diabetes.,"Diabetic foot ulcers are a common, chronic and costly complication of Diabetes, with the greatest risk for ulceration being previous ulceration. Previous approaches to reducing re-ulceration risk have not, however, considered the psychosocial factors which may influence this risk. We reviewed the existing evidence in this area and developed a therapeutic model which informed the content, structure and format of a psychosocial intervention designed to modify the psychosocial risk factors associated with re-ulceration. The intervention was subjected to a qualitative evaluation in a feasibility study which involved a randomised controlled trial in which 10 individuals were randomised to receive the intervention and 5 individuals to usual care. Individuals in both arms participated in in-depth qualitative interviews after the first 10 weeks of the intervention and again after the final maintenance session. The intervention was perceived as acceptable and patients' reported evidence of sustained change in several of the psychosocial risks identified in the therapeutic model. These observations were supported in the descriptive findings obtained from questionnaires measuring mood, cognitions, behaviour and social support. The intervention appears to offer an acceptable and effective way of modifying the psychosocial risk factors associated with re-ulceration.",2012,The intervention was perceived as acceptable and patients' reported evidence of sustained change in several of the psychosocial risks identified in the therapeutic model.,"['psychosocial risk factors associated with foot re-ulceration in diabetes', '10 individuals']",['psychosocial intervention'],['Diabetic foot ulcers'],"[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]",10.0,0.0228124,The intervention was perceived as acceptable and patients' reported evidence of sustained change in several of the psychosocial risks identified in the therapeutic model.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'IWHO, School of Community Health Sciences, University of Nottingham, Jubilee Campus, Nottingham, UK. Kavita.vedhara@nottingham.ac.uk'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Beattie', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Roche', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weinman', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Cullum', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dayan', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ''}]",Behaviour research and therapy,['10.1016/j.brat.2012.02.013']
994,21196441,"Phase III trial of CHOP-21 versus CHOP-14 for aggressive non-Hodgkin's lymphoma: final results of the Japan Clinical Oncology Group Study, JCOG 9809.","BACKGROUND


CHOP-21 has remained the standard chemotherapy for aggressive non-Hodgkin's lymphoma (NHL), and dose intensification is a potential strategy for improving therapeutic results. We conducted a phase III trial to determine whether dose-dense strategy involving interval shortening of CHOP (CHOP-14) is superior to CHOP-21.
PATIENTS AND METHODS


A total of 323 previously untreated patients (aged 15-69 years) with stages II-IV aggressive NHL were randomized. The primary end point was progression-free survival (PFS).
RESULTS


Treatment compliance was comparable in both study arms. At 7-year follow-up, no substantial differences were observed in PFS and overall survival (OS) between CHOP-21 (n = 161) and CHOP-14 (n = 162) arms. Median PFS was 2.8 and 2.6 years with CHOP-21 and CHOP-14, respectively (one-sided log-rank P = 0.79). Eight-year OS and PFS rates were 56% and 42% [95% confidence interval (CI) 47% to 64% and 34% to 49%], respectively, with CHOP-21 and 55% and 38% (95% CI 47% to 63% and 31% to 46%), respectively, with CHOP-14. Subgroup analyses showed no remarkable differences in PFS or OS for patients stratified as per the International Prognostic Index or by age.
CONCLUSION


Dose-intensification strategy involving interval shortening of CHOP did not prolong PFS in advanced, aggressive NHL.",2011,"At 7-year follow-up, no substantial differences were observed in PFS and overall survival (OS) between CHOP-21 (n = 161) and CHOP-14 (n = 162) arms.","['323 previously untreated patients (aged 15-69 years) with stages II-IV aggressive NHL', ""aggressive non-Hodgkin's lymphoma""]","['CHOP-21 versus CHOP-14', 'CHOP (CHOP-14']","['Median PFS', 'PFS rates', 'PFS and overall survival (OS', 'PFS or OS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",323.0,0.15988,"At 7-year follow-up, no substantial differences were observed in PFS and overall survival (OS) between CHOP-21 (n = 161) and CHOP-14 (n = 162) arms.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ohmachi', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Tokai University, Isehara. Electronic address: 8jmmd004@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Hematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Itoh', 'Affiliation': 'Division of Hematology and Oncology, National Cancer Center Hospital East, Kashiwa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nakata', 'Affiliation': 'Division of Hematology and Oncology, National Cancer Center Hospital East, Kashiwa.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'JCOG Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Department of Hematology and Chemotherapy, Aichi Cancer Center, Nagoya.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'Department of Hematology and Chemotherapy, Aichi Cancer Center, Nagoya.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Division of Hematology, Shiga Medical Center for Adults, Moriyama.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ueda', 'Affiliation': 'Second Department of Internal Medicine, Nagoya City University, Nagoya.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Aikawa', 'Affiliation': 'Division of Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pathology, Aichi Cancer Center, Nagoya.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shimoyama', 'Affiliation': 'Division of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hotta', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Tokai University, Isehara; Division of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq619']
995,31916906,Fathers' participation in the HPV vaccination decision-making process doesn't increase parents' intention to make daughters get the vaccine.,"INTRODUCTION


The HPV vaccination rate in Japan has been dismally low. Our previous survey work found that mothers in Japan, who have a strong influence over their daughters, often are receptive to the fathers' participation in the family's decision-making process about getting their daughter HPV vaccinated.
METHODS


We conducted a survey to investigate the nature of the influence of fathers' participation on the mother's decision-making process. From an internet survey panel, we selected a pool of 1,499 eligible mothers who had 12-18 years old daughters. The mothers were randomized into three Groups. To the mothers in Group A, we gave an educational leaflet regarding HPV vaccination and a second leaflet which recommended that they talk with their husbands about the vaccination. To Group B, we gave only the educational leaflet. No leaflets were sent to Group C. A structured survey questionnaire was then distributed through the internet to the mothers.
RESULTS


In Groups A, B, and C, their intention to have their daughter receive the HPV vaccine was 21.6%, 20.7% and 8.2%, respectively. The percent of Group A mothers who thought their husband's opinion was important for when they made the decision was significantly higher (70%) than in Group B (56.6%) or Group C (47.1%).
CONCLUSIONS


The fathers' participation in the mothers' decision-making does not increase the likelihood of HPV vaccination for their daughters. On the other hand, the educational leaflet proved to be effective for this cause.",2020,The fathers' participation in the mothers' decision-making does not increase the likelihood of HPV vaccination for their daughters.,"['1,499 eligible mothers who had 12-18 years old daughters']",[],"['likelihood of HPV vaccination', 'HPV vaccination rate']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337559', 'cui_str': 'Oldest daughter (person)'}]",[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",1499.0,0.0249593,The fathers' participation in the mothers' decision-making does not increase the likelihood of HPV vaccination for their daughters.,"[{'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Egawa-Takata', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka Police Hospital , Osaka, Japan.'}, {'ForeName': 'Ruriko', 'Initials': 'R', 'LastName': 'Nakae', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine , Suita, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Shindo', 'Affiliation': 'Department of Obstetrics and Gynecology, Hannan Central Hospital , Matsubara, Japan.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaizuka City Hospital , Kaizuka, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takiuchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine , Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyatake', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka Police Hospital , Osaka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine , Suita, Japan.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1697107']
996,31400077,Causal explanations of depression and treatment credibility in adults with untreated depression: Examining attribution theory.,"OBJECTIVES


Understanding depression as biologically caused has been shown to impact both treatment preferences and prognostic pessimism. Attribution theory has been posited as an explanation for this relationship. Given that evidence-based psychotherapy is effective yet often not delivered to individuals with depression, the present study sought to determine factors that impact treatment credibility.
DESIGN


Non-treatment-seeking, depressed individuals (n = 229) were randomly assigned to read a psychoeducation article about depression that consisted of a biological causal explanation, psychosocial causal explanation, or a non-causal control.
METHODS


Attributional dimensions of locus, stability, and control were examined as mediating the relationship between causal explanation and treatment credibility and prognostic pessimism.
RESULTS


Individuals in the biological condition were more likely to find antidepressant medication a credible treatment for depression. The manipulation had no direct effect on preference for psychotherapy or prognostic pessimism. Attributional dimensions of locus, stability, and control did not mediate the relationship between causal explanation and treatment credibility. To the extent that the psychosocial article increased perceived instability of the depression cause, however, prognostic pessimism was reduced.
CONCLUSIONS


The present study has implications for framing education about depression in mental health literacy programs and public awareness campaigns.
PRACTITIONER POINTS


This study found that conceptualizing depression as biologically caused increased the credibility of medication but not psychotherapy Participants reading a biological explanation of depression demonstrated an increase on some aspects of stigma and prognostic pessimism Emphasizing the person-environment interaction rather than biological causes decreased the perceived stability of depression which was associated with a decrease in prognostic pessimism.",2020,This study found that conceptualizing depression as biologically caused increased the credibility of medication but not psychotherapy Participants reading a biological explanation of depression demonstrated an increase on some aspects of stigma and prognostic pessimism Emphasizing the person-environment interaction rather than biological causes decreased the perceived stability of depression which was associated with a decrease in prognostic pessimism.,"['adults with untreated depression', 'Non-treatment-seeking, depressed individuals (n\xa0=\xa0229']","['psychoeducation article about depression that consisted of a biological causal explanation, psychosocial causal explanation, or a non-causal control']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0239839,This study found that conceptualizing depression as biologically caused increased the credibility of medication but not psychotherapy Participants reading a biological explanation of depression demonstrated an increase on some aspects of stigma and prognostic pessimism Emphasizing the person-environment interaction rather than biological causes decreased the perceived stability of depression which was associated with a decrease in prognostic pessimism.,"[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Psychology, University of Nevada, Reno, Nevada, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Papa', 'Affiliation': 'Department of Psychology, University of Nevada, Reno, Nevada, USA.'}]",Psychology and psychotherapy,['10.1111/papt.12247']
997,22035502,"Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings: patient's home, GP surgery and hospital day unit.","BACKGROUND


The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP) surgeries.
METHODS/DESIGN


Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm), or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire), as well as secondary end points: patient satisfaction, safety and health economics.
DISCUSSION


The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key stakeholders regarding potential costs and benefits of transferring clinical services from hospital to the community.
TRIAL REGISTRATION NUMBER


ISRCTN: ISRCTN66219681.",2011,The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment.,"['Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network', ""three different settings: patient's home, GP surgery and hospital day unit"", 'out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment', ""hospital with delivery in two different community settings: the patient's home and general practice (GP) surgeries""]",['cancer systemic therapy'],"['satisfaction, safety and health economics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0442593', 'cui_str': 'General practice premises (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}]",,0.147328,The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment.,"[{'ForeName': 'Pippa G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK. pippa.corrie@addenbrookes.nhs.uk""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moody', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bavister', 'Affiliation': ''}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Prevost', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Sabes-Figuera', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Balsdon', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKinnon', 'Affiliation': ''}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': ""O'Sullivan"", 'Affiliation': ''}, {'ForeName': 'Ray S', 'Initials': 'RS', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Stephen Ig', 'Initials': 'SI', 'LastName': 'Barclay', 'Affiliation': ''}]",BMC cancer,['10.1186/1471-2407-11-467']
998,31537908,"Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer.","BACKGROUND


Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.
METHODS


In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6  ≥ 30% as unacceptable.
RESULTS


BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
CONCLUSIONS


BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity.
CLINICAL TRIAL REGISTRATION


NCT01735071 (Clinicaltrials.gov).",2019,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","['women with partially platinum-sensitive recurrent ovarian cancer', 'women progressing between 6 and 12 months since their last platinum-based therapy']","['BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin', 'bevacizumab', 'trabectedin and bevacizumab', 'bevacizumab and trabectedin with or without carboplatin']","['efficacy and safety', 'progression-free survival rate (PFS-6) and severe toxicity rate (ST-6']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.202843,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Zaccarelli', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Baldoni', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Frezzini', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Palluzzi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Tognon', 'Affiliation': 'UO Ostetricia e Ginecologia - ASST degli Spedali Civili di Brescia, Università degli Studi, Brescia, Italy.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Lissoni', 'Affiliation': 'Università di Milano-Bicocca, Clinica Ostetrica e Ginecologica, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'AO Ordine Mauriziano, SCDU Ginecologia ed Ostetricia, Torino, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': 'ASST Fatebenefratelli Sacco, UOC di Oncologia, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Negri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pesenti Gritti', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Biagioli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gerardi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Roldano', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. roldano.fossati@marionegri.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': ""D'Incalci"", 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}]",British journal of cancer,['10.1038/s41416-019-0584-5']
999,21571595,An RCT: use of oxytocin drip during hysteroscopic endometrial resection and its effect on operative blood loss and glycine deficit.,"OBJECTIVE


To estimate the influence of oxytocin infusion on operative blood loss and glycine deficit during hysteroscopic transcervical endometrial resection (TCRE) for abnormal uterine bleeding (AUB).
DESIGN


Prospective, randomized, placebo-controlled study (Canadian Task Force classification I).
SETTING


Tertiary Care University Hospital.
PATIENTS


Forty-eight women with abnormal uterine bleeding that was unresponsive to conservative medical management were randomly assigned to undergo hysteroscopic TCRE with either oxytocin infusion (group A) or saline (group B). Intravenous Ringer's lactate solution was used during surgery.
INTERVENTIONS


TCRE was carried out with glycine 1.5% mixed with 2% ethanol as a distension medium. For group A: one ampoule of oxytocin (10 U/mL/amp) was added to 500 mL Ringer's lactate solution running at a rate of 400 mU/min during surgery. In group B, one ampoule of saline solution was added to the Ringer's solution and run at a similar rate. The amount of distension medium used, fluid deficit, blood levels of albumin and ethanol, hematocrit, hemoglobin, changes in serum sodium levels (Na+), and central venous pressure were compared between the groups.
MEASUREMENTS AND MAIN RESULTS


The mean volume of distension fluid used and operating time were not significantly different in both groups (4.18 ± 0.2 vs 4.5 ± 0.5 L, and 28.3 ± 4.2 vs 27.5 ± 5.4 min, respectively). Although operating time, volume of distension fluid used, decrease in albumin level and hematocrit were less in the oxytocin than in the saline group, the differences were not statistically significant. The ethanol levels in blood, decrease in serum Na+, and glycine deficit were significantly lower in the oxytocin than in the saline group (17.4 ± 3.8 vs 25.3 ± 4.2 mg/ml, 6.7 ± 1.2 vs 9.1 ± 0.9 mEq/L, and 0.49 ± 0.08 vs 0.66 ± 0.05 L, respectively; p <.05). There was no significant difference in mean total uterine size, endometrial thickness, weight of resected tissue, and other demographic data between the study groups.
CONCLUSIONS


Oxytocin infusion combined with skillful surgical techniques may prevent fluid overload and glycine deficit during hysteroscopic TCRE for abnormal uterine bleeding. Although there is a trend toward a decrease in operative blood loss, further randomized trials are required to confirm this finding.",2011,"There was no significant difference in mean total uterine size, endometrial thickness, weight of resected tissue, and other demographic data between the study groups.
","['Forty-eight women with abnormal uterine bleeding that was unresponsive to conservative medical management', 'Tertiary Care University Hospital']","['glycine 1.5% mixed with 2% ethanol', 'oxytocin', 'placebo', 'hysteroscopic TCRE with either oxytocin infusion (group A) or saline', ""Intravenous Ringer's lactate solution"", 'saline solution', 'oxytocin infusion', 'hysteroscopic transcervical endometrial resection (TCRE', 'Oxytocin']","['mean volume of distension fluid used and operating time', 'mean total uterine size, endometrial thickness, weight of resected tissue, and other demographic data', 'operative blood loss', 'fluid overload and glycine deficit', 'amount of distension medium used, fluid deficit, blood levels of albumin and ethanol, hematocrit, hemoglobin, changes in serum sodium levels (Na+), and central venous pressure', 'albumin level and hematocrit', 'operative blood loss and glycine deficit', 'ethanol levels in blood, decrease in serum Na+, and glycine deficit']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding (disorder)'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C0404115', 'cui_str': 'Endometrial resection (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0449896', 'cui_str': 'Fluid used (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0449818', 'cui_str': 'Weight of resected tissue (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0449892', 'cui_str': 'Medium used (attribute)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement (procedure)'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",48.0,0.251626,"There was no significant difference in mean total uterine size, endometrial thickness, weight of resected tissue, and other demographic data between the study groups.
","[{'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shokeir', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University Hospital, Mansoura Faculty of Medicine, Mansoura, Egypt. tarekshokeir1@hotmail.com'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'El-Lakkany', 'Affiliation': ''}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Sadek', 'Affiliation': ''}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'El-Shamy', 'Affiliation': ''}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Abu Hashim', 'Affiliation': ''}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2011.03.015']
1000,31455824,"Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.",,2019,,['preterm infants'],"['placebo', 'Morphine']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.11121,,"[{'ForeName': 'Omri David', 'Initials': 'OD', 'LastName': 'Soffer', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA. Omri.soffer@childrens.harvard.edu.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelissen', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Berde', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0476-9']
1001,31530444,Mechanical zona pellucida removal of vitrified-warmed human blastocysts does not affect the clinical outcome.,"RESEARCH QUESTION


Does complete mechanical removal of the zona pellucida modify the outcome of transfer of vitrified-warmed human blastocysts?
DESIGN


In a prospective randomized controlled study, 419 couples were allocated to either zona pellucida-free (n = 209) or zona intact (n = 210) vitrified-warmed embryo transfer. Main outcome measures included clinical pregnancy, implantation and ongoing pregnancy rates.
RESULTS


Transfer of zona pellucida-free blastocysts resulted in clinical pregnancy, implantation and ongoing pregnancy rates (35,9%, 33,9% and 32,1%, respectively), similar to those achieved with zona intact control embryos (39%, 36,4% and 33,1%, respectively).
CONCLUSION


Total mechanical removal of the zona pellucida did not affect the tested parameters of clinical outcomes.",2019,"RESULTS


Transfer of zona pellucida-free blastocysts resulted in clinical pregnancy, implantation and ongoing pregnancy rates (35,9%, 33,9% and 32,1%, respectively), similar to those achieved with zona intact control embryos (39%, 36,4% and 33,1%, respectively).
",['419 couples'],['zona pellucida-free (n\u202f=\u202f209) or zona intact (n\u202f=\u202f210) vitrified-warmed embryo transfer'],"['clinical pregnancy, implantation and ongoing pregnancy rates']","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0043519', 'cui_str': 'Zona Pellucida'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",419.0,0.0962001,"RESULTS


Transfer of zona pellucida-free blastocysts resulted in clinical pregnancy, implantation and ongoing pregnancy rates (35,9%, 33,9% and 32,1%, respectively), similar to those achieved with zona intact control embryos (39%, 36,4% and 33,1%, respectively).
","[{'ForeName': 'Konstantine V', 'Initials': 'KV', 'LastName': 'Kirienko', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Valentina P', 'Initials': 'VP', 'LastName': 'Apryshko', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia; Lomonosov Moscow State University, Faculty of Biology, 1/12 Leninskie gori, Moscow 119234, Russia.'}, {'ForeName': 'Anna A', 'Initials': 'AA', 'LastName': 'Naumova', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Margarita A', 'Initials': 'MA', 'LastName': 'Kharitonova', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Aleksey A', 'Initials': 'AA', 'LastName': 'Klepukov', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Anton I', 'Initials': 'AI', 'LastName': 'Bolt', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Irina Y', 'Initials': 'IY', 'LastName': 'Ermilova', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Anna G', 'Initials': 'AG', 'LastName': 'Mironova', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia; Emanuel Institute of Biochemical Physics, Russian Academy of Sciences, Kosygina st., 4., Moscow 119334, Russia.'}, {'ForeName': 'Yana V', 'Initials': 'YV', 'LastName': 'Bozina', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Elena B', 'Initials': 'EB', 'LastName': 'Lebedeva', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia.'}, {'ForeName': 'Ekaterina Y', 'Initials': 'EY', 'LastName': 'Simonenko', 'Affiliation': 'Lomonosov Moscow State University, Faculty of Physics, Biophysics Department, 1/2 Leninskie gori, Moscow 119991, Russia.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Vajta', 'Affiliation': 'RVT Australia, 20 Slate Close, Brinsmead QLD 4870, Australia. Electronic address: gabor.vajta@hotmail.com.'}, {'ForeName': 'Sergey A', 'Initials': 'SA', 'LastName': 'Yakovenko', 'Affiliation': 'Altravita IVF Clinic, 4A Nagornaya 117186, Moscow, Russia; Lomonosov Moscow State University, Faculty of Physics, Biophysics Department, 1/2 Leninskie gori, Moscow 119991, Russia.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.06.003']
1002,31317805,Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect.,"The stepped-wedge design for pragmatic clinical trials has received increased attention in health service-related research seeking to evaluate the effect of interventions. Compared with the parallel design, the stepped-wedge design is preferred when there is prior knowledge supporting the effectiveness and harmlessness of the intervention, and/or when practical or financial constraints exist such that the intervention can only be implemented sequentially on a fraction of clusters. In some health service studies, the study period may consist of two parts: an active implementation followed by a sustainability phase, where the intervention effect is possibly reduced. There is a gap in current literature of the stepped-wedge design for cluster randomization trials for dealing with this specific scenario. We aim to provide an analytical formula for power analysis under this situation to aid the stepped-wedge design of an ongoing PREVENT trial.",2019,We aim to provide an analytical formula for power analysis under this situation to aid the stepped-wedge design of an ongoing PREVENT trial.,[],[],[],[],[],[],,0.139839,We aim to provide an analytical formula for power analysis under this situation to aid the stepped-wedge design of an ongoing PREVENT trial.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'a Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University , Indianapolis , IN , USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'b Department of Biostatistics, College of Public Health, University of Nebraska Medical Center , Omaha , NE , USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Myers', 'Affiliation': 'c Health Services Research Service, Richard L. Roudebush VA Medical Center , Indianapolis , IN , USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'c Health Services Research Service, Richard L. Roudebush VA Medical Center , Indianapolis , IN , USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1633658']
1003,31409130,Noninferiority trials with nonadherence to the assigned randomized treatment.,"BACKGROUND


Nonadherence to treatment assignment in a noninferiority randomized trial is especially problematic because it attenuates observed differences between the treatment arms, possibly leading one to conclude erroneously that a truly inferior experimental therapy is noninferior to a standard therapy (inflated type 1 error probability). The Lachin-Foulkes adjustment is an increase in the sample size to account for random nonadherence for the design of a superiority trial with a time-to-event outcome; it has not been explored in the noninferiority trial setting nor with nonrandom nonadherence. Noninferiority trials where patients have knowledge of a personal prognostic risk score may lead to nonrandom nonadherence, as patients with a relatively high risk may be more likely to not adhere to the random assignment to the (reduced) experimental therapy, and patients with a relatively low risk score may be more likely to not adhere to the random assignment to the (more aggressive) standard therapy.
METHODS


We investigated via simulations the properties of the Lachin-Foulkes adjustment in the noninferiority setting. We considered nonrandom in addition to random nonadherence to the treatment assignment. For nonrandom nonadherence, we used the scenario where a risk score, potentially associated with the between-arm treatment difference, influences patients' nonadherence. A sensitivity analysis is proposed for addressing the nonrandom nonadherence for this scenario. The noninferiority TAILORx adjuvant breast cancer trial, where eligibility was based on a genomic risk score, is used as an example throughout.
RESULTS


The Lachin-Foulkes adjustment to the sample size improves the operating characteristics of noninferiority trials with random nonadherence. However, to maintain type 1 error probability, it is critical to adjust the noninferiorty margin as well as the sample size. With nonrandom nonadherence that is associated with a prognostic risk score, the type 1 error probability of the Lachin-Foulkes adjustment can be inflated (e.g. doubled) when the nonadherence is larger in the experimental arm than the standard arm. The proposed sensitivity analysis lessens the inflation in this situation.
CONCLUSION


The Lachin-Foulkes adjustment to the sample size and noninferiority margin is a useful simple technique for attenuating the effects of random nonadherence in the noninferiority setting. With nonrandom nonadherence associated with a risk score known to the patients, the type 1 error probability can be inflated in certain situations. A proposed sensitivity analysis for these situations can attenuate the inflation.",2019,The Lachin-Foulkes adjustment to the sample size improves the operating characteristics of noninferiority trials with random nonadherence.,[],[],[],[],[],[],,0.0819543,The Lachin-Foulkes adjustment to the sample size improves the operating characteristics of noninferiority trials with random nonadherence.,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Korn', 'Affiliation': 'Biometric Research Program, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Freidlin', 'Affiliation': 'Biometric Research Program, National Cancer Institute, Bethesda, MD, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519868479']
1004,20047672,"A randomised controlled trial and cost-effectiveness evaluation of ""booster"" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods.","BACKGROUND


Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. There is an absence of evidence about whether follow up beyond three months can maintain long term physical activity. This study assesses whether it is worth providing motivational interviews, three months after giving initial advice, to those who have become more active.
METHODS/DESIGN


Study candidates (n = 1500) will initially be given an interactive DVD and receive two telephone follow ups at monthly intervals checking on receipt and use of the DVD. Only those that have increased their physical activity after three months (n = 600) will be randomised into the study. These participants will receive either a ""mini booster"" (n = 200), ""full booster"" (n = 200) or no booster (n = 200). The ""mini booster"" consists of two telephone calls one month apart to discuss physical activity and maintenance strategies. The ""full booster"" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual maintain their increase in physical activity. Differences in physical activity, quality of life and costs associated with the booster interventions, will be measured three and nine months from randomisation. The research will be conducted in 20 of the most deprived neighbourhoods in Sheffield, which have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation, to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities. A one-year integrated feasibility study will confirm that recruitment targets are achievable based on a 10% sample.
DISCUSSION


The choice of study population, study interventions, brief intervention preceding the study, and outcome measure are discussed.
TRIAL REGISTRATION


Current Controlled Trials: ISRCTN56495859; ClinicalTrials.gov: NCT00836459.",2010,"Differences in physical activity, quality of life and costs associated with the booster interventions, will be measured three and nine months from randomisation.","['Study candidates (n = 1500', 'Participants will be recruited through general practices and community groups, as well as by postal invitation, to ensure the participation of minority ethnic groups and those with lower levels of literacy', 'previously sedentary people', 'middle-aged adults in deprived urban neighbourhoods']","['mini booster', 'full booster"" (n = 200) or no booster', 'interactive DVD and receive two telephone follow ups at monthly intervals checking on receipt and use of the DVD', 'booster"" interventions']","['physical activity', 'physical activity, quality of life and costs']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1500.0,0.0743693,"Differences in physical activity, quality of life and costs associated with the booster interventions, will be measured three and nine months from randomisation.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hind', 'Affiliation': 'Clinical Trials Research Unit, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Copeland', 'Affiliation': ''}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Breckon', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Crank', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Walters', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Brazier', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Nicholl', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goyder', 'Affiliation': ''}]",BMC public health,['10.1186/1471-2458-10-3']
1005,20017932,Adolescent type 1 Diabetes Cardio-renal Intervention Trial (AdDIT).,"BACKGROUND


The prognosis for young people diagnosed with diabetes during childhood remains poor and this is mainly related to the long-term risk of developing vascular complications.Microalbuminuria identifies subjects at risk for diabetic nephropathy (DN) and cardiovascular disease (CVD). It is often detected in adolescence but is rarely treated before the age of 18 years, as at the end of puberty albumin excretion may decline and in some subjects will return into the normal range. However, evidence indicates that subjects with both transient and persistent microalbuminuria have experienced renal damage during puberty and thus reno-protection to prevent long-term complications is warranted. In adults with diabetes and microalbuminuria, the use of angiotensin converting enzyme inhibitors (ACEI) and Statins is increasing, and in order to determine whether these agents are of value in the adolescent population a large randomized controlled clinical trial is needed.
METHODS/DESIGN


The Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT) is a multi-center, randomized, double-blind, placebo-controlled trial of ACEI and Statin therapy in adolescents with type 1 diabetes. 500 high-risk adolescents, defined on the basis of their albumin excretion, are randomized to receive either ACEI (Quinapril) or Statins (Atorvastatin) or combination therapy or placebo for 3-4 years. There will also be a parallel open observational study, based on the follow-up of 400 low-risk non-randomized adolescents. The major endpoint of the study is the change in albumin excretion; secondary endpoints include markers of CVD, renal function, retinopathy, quality of life combined with assessment of compliance and potential health economic benefits.
DISCUSSION


AdDIT will provide important data on the potential renal and cardiovascular protective effects of ACEI and Statins in high-risk adolescents. Long-term follow-up of the randomized subjects will provide direct evidence of disease outcomes, in addition to the data on early surrogate measures of DN and CVD. Follow-up of non-randomized low-risk subjects will determine the potential impact of intervention on DN and CVD. AdDIT will help to determine whether, in addition to encouraging young people to achieve good glycaemic control, pharmacological cardio-renal protection should also be implemented. EUDRACT NUMBER: 2007-001039-72
TRIAL REGISTRATION NUMBER


ISRCTN91419926.",2009,Microalbuminuria identifies subjects at risk for diabetic nephropathy (DN) and cardiovascular disease (CVD).,"['Microalbuminuria identifies subjects at risk for diabetic nephropathy (DN) and cardiovascular disease (CVD', 'adults with diabetes and microalbuminuria', 'Adolescent type 1 Diabetes Cardio-renal Intervention Trial (AdDIT', '400 low-risk non-randomized adolescents', 'adolescents with type 1 diabetes', 'young people diagnosed with diabetes during childhood', '500 high-risk adolescents', 'high-risk adolescents']","['angiotensin converting enzyme inhibitors (ACEI', 'ACEI (Quinapril) or Statins (Atorvastatin) or combination therapy or placebo', 'placebo', 'ACEI and Statin therapy']","['markers of CVD, renal function, retinopathy, quality of life combined with assessment of compliance and potential health economic benefits']","[{'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0034380'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}]",,0.149607,Microalbuminuria identifies subjects at risk for diabetic nephropathy (DN) and cardiovascular disease (CVD).,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Department of Paediatrics, University of Cambridge, Level 8 Box 116, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK. dbd25@cam.ac.uk""}]",BMC pediatrics,['10.1186/1471-2431-9-79']
1006,31427344,"RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.","INTRODUCTION


Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.
METHODS AND ANALYSIS


Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .
ETHICS AND DISSEMINATION


Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).",2019,"For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .
","['Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities', 'patients with chronic, disabling LBP']","['individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT', 'Cognitive functional therapy with or without movement sensor biofeedback versus usual care', 'CFT', 'CFT-plus-movement-sensor-biofeedback', 'individualised CFT delivered with or without movement sensor biofeedback']","['physical activity limitation', 'pain-related physical activity limitation (Roland Morris Disability Questionnaire']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0222045'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.178024,"For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kent', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia peter.kent@curtin.edu.au.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': 'Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Amity', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Alison H', 'Initials': 'AH', 'LastName': 'McGregor', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartvigsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'Sports Spine Centre, Aspetar Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Vickery', 'Affiliation': 'General Practice, The University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Caneiro', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schütze', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Laird', 'Affiliation': 'Superspine, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Attwell', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hancock', 'Affiliation': 'Department of Health Professions, Macquarie University, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-031133']
1007,23868905,"Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer.","BACKGROUND


The phase III CLEOPATRA study demonstrated that combining pertuzumab with trastuzumab plus docetaxel significantly improves progression-free and overall survival in previously untreated HER2-positive metastatic breast cancer. Here, we report health-related quality-of-life (HRQoL) results from CLEOPATRA.
PATIENTS AND METHODS


Participants were randomly assigned to pertuzumab or placebo, each given with trastuzumab plus docetaxel every 3 weeks. Pertuzumab and trastuzumab were administered until progression and six or more docetaxel cycles were recommended. Time from randomization to a ≥ 5-point decrease in Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire was analyzed as a prespecified secondary end point. A post hoc exploratory analysis investigated time to ≥ 2-point deterioration in Breast Cancer Subscale (BCS) score.
RESULTS


Time to ≥ 5-point decline in TOI-PFB did not differ significantly between the pertuzumab and placebo arms [hazard ratio (HR), 0.97; P = 0.7161]. The median times to TOI-PFB deterioration were 18.4 and 18.3 weeks, respectively (approximately six cycles). The mean TOI-PFB declined slightly until week 18 and recovered thereafter. Pertuzumab increased time until BCS deterioration versus placebo (median 26.7 versus 18.3 weeks; HR, 0.77; P = 0.0061).
CONCLUSIONS


Combining pertuzumab with trastuzumab and docetaxel had no adverse impact on HRQoL and may prolong time to worsening of breast cancer-specific symptoms.",2013,"Pertuzumab increased time until BCS deterioration versus placebo (median 26.7 versus 18.3 weeks; HR, 0.77; P = 0.0061).
","['metastatic breast cancer', 'Participants']","['placebo', 'Pertuzumab and trastuzumab', 'trastuzumab and docetaxel', 'pertuzumab with trastuzumab plus docetaxel', 'trastuzumab plus docetaxel', 'pertuzumab or placebo']","['Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) of the Functional Assessment of Cancer Therapy-Breast', 'mean TOI-PFB', 'time to ≥ 2-point deterioration in Breast Cancer Subscale (BCS) score', 'progression-free and overall survival', 'median times to TOI-PFB deterioration', 'Time to ≥ 5-point decline in TOI-PFB', 'time until BCS deterioration']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0681933,"Pertuzumab increased time until BCS deterioration versus placebo (median 26.7 versus 18.3 weeks; HR, 0.77; P = 0.0061).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""Department of Oncology, Vall D'Hebron University Hospital, Barcelona, Spain. Electronic address: jacortes@vhebron.net.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, USA.'}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Division of Hematology/Medical Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.'}, {'ForeName': 'S-A', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Division of Hematology/Medical Oncology, Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Medical Oncology, CHU Jean Minjoz, Besançon, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ross', 'Affiliation': 'Medical Affairs, Roche Products Limited, Welwyn, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Medical Affairs, Roche Products Limited, Welwyn, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Knott', 'Affiliation': 'Medical Affairs, Roche Products Limited, Welwyn, UK.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Washington Cancer Institute, MedStar Washington Hospital Center, Washington, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt274']
1008,31856900,"Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol.","BACKGROUND


Current international guidelines recommend the use of a daily topical exit-site antimicrobial to prevent peritoneal dialysis (PD)-related infections. Although nonantibiotic-based therapies are appealing because they may limit antimicrobial resistance, no controlled trials have been conducted to compare topical antimicrobial agents with usual exit-site care for the prevention of PD-related infections among the Thai PD population. We propose a controlled three-arm trial to examine the efficacy and safety of a daily chlorhexidine gluconate-impregnated patch versus mupirocin ointment versus usual exit-site care with normal saline for the prevention of PD-related infections.
METHODS/DESIGNS


This study is a randomized, double-blind, multicenter, active-controlled, clinical trial. Adult patients aged 18 years or older who have end-stage kidney disease and are undergoing PD will be enrolled at three PD Centers in Thailand. A total of 354 PD patients will be randomly assigned to either the 2% chlorhexidine gluconate-impregnated patch, mupirocin ointment, or usual exit-site care with normal saline dressing according to a computer-generated random allocation sequence. Participants will be followed until discontinuation of PD or completion of 24 months. The primary study outcomes are time to first PD-related infection (exit-site/tunnel infection or peritonitis) event and the overall difference in PD-related infection rates between study arms. Secondary study outcomes will include (i) the rate of infection-related catheter removal and PD technique failure, (ii) rate of nasal and exit-site Staphylococcus aureus colonization, (iii) healthcare costs, and (iv) skin reactions and adverse events. We plan to conduct a cost-utility analysis alongside the trial from the perspectives of patients and society. A Markov simulation model will be used to estimate the total cost and health outcome in terms of quality-adjusted life years (QALYs) over a 20-year time horizon. An incremental cost-effectiveness ratio in Thai Baht and U.S. dollars per QALYs gained will be illustrated. A series of probabilistic sensitivity analyses will be conducted to assess the robustness of the cost-utility analysis findings.
DISCUSSION


The results from this study will provide new clinical and cost-effectiveness evidence to support the best strategy for the prevention of PD-related infections among the Thai PD population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02547103. Registered on September 11, 2015.",2019,The primary study outcomes are time to first PD-related infection (exit-site/tunnel infection or peritonitis) event and the overall difference in PD-related infection rates between study arms.,"['patients and society', '354 PD patients', 'Adult patients aged 18 years or older who have end-stage kidney disease and are undergoing PD will be enrolled at three PD Centers in Thailand']","['Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline', 'chlorhexidine gluconate-impregnated patch, mupirocin ointment, or usual exit-site care with normal saline dressing according to a computer-generated random allocation sequence', 'chlorhexidine gluconate-impregnated patch versus mupirocin ointment']","['rate of infection-related catheter removal and PD technique failure, (ii) rate of nasal and exit-site Staphylococcus aureus colonization, (iii) healthcare costs, and (iv) skin reactions and adverse events', 'total cost and health outcome', 'efficacy and safety', 'time to first PD-related infection (exit-site/tunnel infection or peritonitis) event and the overall difference in PD-related infection rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}]","[{'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.492886,The primary study outcomes are time to first PD-related infection (exit-site/tunnel infection or peritonitis) event and the overall difference in PD-related infection rates between study arms.,"[{'ForeName': 'Surapon', 'Initials': 'S', 'LastName': 'Nochaiwong', 'Affiliation': 'Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, 50200, Thailand. surapon.nochaiwong@gmail.com.'}, {'ForeName': 'Chidchanok', 'Initials': 'C', 'LastName': 'Ruengorn', 'Affiliation': 'Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Kajohnsak', 'Initials': 'K', 'LastName': 'Noppakun', 'Affiliation': 'Pharmacoepidemiology and Statistics Research Center (PESRC), Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Setthapon', 'Initials': 'S', 'LastName': 'Panyathong', 'Affiliation': 'Pharmacoepidemiology and Statistics Research Center (PESRC), Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Phongsak', 'Initials': 'P', 'LastName': 'Dandecha', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Manish M', 'Initials': 'MM', 'LastName': 'Sood', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada.'}, {'ForeName': 'Chalermpong', 'Initials': 'C', 'LastName': 'Saenjum', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Ratanaporn', 'Initials': 'R', 'LastName': 'Awiphan', 'Affiliation': 'Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Sasithorn', 'Initials': 'S', 'LastName': 'Sirilun', 'Affiliation': 'Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Pajaree', 'Initials': 'P', 'LastName': 'Mongkhon', 'Affiliation': 'Pharmacoepidemiology and Statistics Research Center (PESRC), Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Wilaiwan', 'Initials': 'W', 'LastName': 'Chongruksut', 'Affiliation': 'Pharmacoepidemiology and Statistics Research Center (PESRC), Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Pharmacoepidemiology and Statistics Research Center (PESRC), Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3953-8']
1009,21042188,Prospective clinical trial comparing outcome measures between Furlow and von Langenbeck Palatoplasties for UCLP.,"The goal of this prospective randomized clinical trial was to compare 2 cohorts of standardized cleft patients with regard to functional speech outcome and the presence or absence of palatal fistulae. The 2 cohorts are randomized to undergo either a conventional von Langenbeck repair with intravelar velarplasty or the double-opposing Z-plasty Furlow procedure. A prospective 2 × 2 × 2 factorial clinical trial was used in which each subject was randomly assigned to 1 of 8 different groups: 1 of 2 different lip repairs (Spina vs. Millard), 1 of 2 different palatal repair (von Langenbeck vs. Furlow), and 1 of 2 different ages at time of palatal surgery (9-12 months vs. 15-18 months). All surgeries were performed by the same 4 surgeons. A cul-de-sac test of hypernasality and a mirror test of nasal air emission were selected as primary outcome measures for velopharyngeal function. Both a surgeon and speech pathologist examined patients for the presence of palatal fistulae. In this study, the Furlow double-opposing Z-palatoplasty resulted in significantly better velopharyngeal function for speech than the von Langenbeck procedure as determined by the perceptual cul-de-sac test of hypernasality. Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck. Fistulas were more likely to occur in patients with wider clefts and when relaxing incisions were not used.",2011,Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck.,['2 cohorts of standardized cleft patients with regard to functional speech outcome and the presence or absence of palatal fistulae'],"['2 different lip repairs (Spina vs. Millard), 1 of 2 different palatal repair (von Langenbeck vs. Furlow', 'conventional von Langenbeck repair with intravelar velarplasty or the double-opposing Z-plasty Furlow procedure']","['Fistula occurrence', 'velopharyngeal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0192038', 'cui_str': 'Repair of lip (procedure)'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0184998', 'cui_str': 'Plastic repair by z plasty (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0475716,Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck.,"[{'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Williams', 'Affiliation': 'Craniofacial Center, College of Dentistry, University of Florida, Gainesville, FL, USA. williams @dental.ufl.edu'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'Seagle', 'Affiliation': ''}, {'ForeName': 'Maria Ines', 'Initials': 'MI', 'LastName': 'Pegoraro-Krook', 'Affiliation': ''}, {'ForeName': 'Telma V', 'Initials': 'TV', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garla', 'Affiliation': ''}, {'ForeName': 'Marcos L', 'Initials': 'ML', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'José S', 'Initials': 'JS', 'LastName': 'Machado Neto', 'Affiliation': ''}, {'ForeName': 'Jeniffer C R', 'Initials': 'JC', 'LastName': 'Dutka', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nackashi', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Boggs', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': ''}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Moorhead', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wharton', 'Affiliation': ''}, {'ForeName': 'Maria I G', 'Initials': 'MI', 'LastName': 'Graciano', 'Affiliation': ''}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Pimentel', 'Affiliation': ''}, {'ForeName': 'Mariza', 'Initials': 'M', 'LastName': 'Feniman', 'Affiliation': ''}, {'ForeName': 'Silvia H A', 'Initials': 'SH', 'LastName': 'Piazentin-Penna', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kemker', 'Affiliation': ''}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Zimmermann', 'Affiliation': ''}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bento-Gonçalvez', 'Affiliation': ''}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Borgo', 'Affiliation': ''}, {'ForeName': 'Ilza L', 'Initials': 'IL', 'LastName': 'Marques', 'Affiliation': ''}, {'ForeName': 'Angela P M C', 'Initials': 'AP', 'LastName': 'Martinelli', 'Affiliation': ''}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Jorge', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Antonelli', 'Affiliation': ''}, {'ForeName': 'Josiane F A', 'Initials': 'JF', 'LastName': 'Neves', 'Affiliation': ''}, {'ForeName': 'Melina E', 'Initials': 'ME', 'LastName': 'Whitaker', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0b013e3181d60763']
1010,31478436,"High-intensity interval neuromuscular training promotes exercise behavioral regulation, adherence and weight loss in inactive obese women.","It is unclear how high-intensity, interval-type nontraditional exercise training programmes can be feasible and effective options for inactive obese individuals. This randomized controlled trial investigated the hypothesis that a 10-month high-intensity, interval-type neuromuscular training programme (DoIT) with adjunct portable modalities, performed in a small-group setting, induces improvements in psychological well-being, subjective vitality and exercise behavioural regulations in obese women. Associations between adherence, psychological and physiological indicators were also investigated. Forty-nine previously inactive obese females (36.4 ± 4.4 yrs) were randomly assigned to three groups (control;  N  = 21, 10-month training;  N  = 14, or 5-month training plus 5 month-detraining;  N  = 14). DoIT was a supervised, progressive, and time-efficient (<30 min) programme that used 10-12 functional/neuromotor exercises and prescribed work and rest time intervals (20-40 sec) in a circuit fashion (1-3 rounds) for 10 months. Questionnaires were used to measure psychological distress, subjective vitality, and behavioural regulations in exercise at pre-, mid-, and post-intervention. The 10-month training reduced psychological distress (72%,  p  = 0.001), external regulation (75%,  p  = 0.011) and increased vitality (53%,  p  = 0.001), introjected regulation (63%,  p  = 0.001), intrinsic regulation (33%,  p  = 0.004), and identified regulation (88%,  p  = 0.001). A moderate to strong positive relationship was found between adherence rate and identified regulation scores ( r  = 0.59,  p  = 0.001) and between VO 2 peak and identified regulation scores ( r  = 0.59,  p  = 0.001). A mild dissociation between exercise intensity and perceived exertion was also observed. Our novel findings suggest that a 10-month implementation of a high-intensity interval neuromuscular training programme promotes positive psychological adaptations provoking exercise behavioural regulation and adherence while inducing weight loss in inactive obese women.",2020,"The 10-month training reduced psychological distress (72%, p = 0.001), external regulation (75%, p = 0.011) and increased vitality (53%, p = 0.001), introjected regulation (63%, p = 0.001), intrinsic regulation (33%, p = 0.004), and identified regulation (88%, p = 0.001).","['inactive obese individuals', 'previously inactive obese women', 'obese women', 'Inactive Obese Women', 'Forty-nine previously inactive obese females (36.4\u2009±\u20094.4 yrs']","['High-Intensity Interval Neuromuscular Training', 'interval-type neuromuscular training program (DoIT) with adjunct portable modalities']","['introjected regulation', 'adherence rate and identified regulation scores', 'weight loss', 'VO 2 peak and identified regulation scores', 'increased vitality', 'psychological distress', 'psychological distress, subjective vitality, and behavioral regulations in exercise at pre-, mid-, and post-intervention', 'psychological well-being, subjective vitality and exercise behavioral regulations', 'external regulation', 'intrinsic regulation']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517761', 'cui_str': '4.4'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}]",49.0,0.080607,"The 10-month training reduced psychological distress (72%, p = 0.001), external regulation (75%, p = 0.011) and increased vitality (53%, p = 0.001), introjected regulation (63%, p = 0.001), intrinsic regulation (33%, p = 0.004), and identified regulation (88%, p = 0.001).","[{'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Loules', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Georgakouli', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Tsimeas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, Komotini, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papanikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Chariklia K', 'Initials': 'CK', 'LastName': 'Deli', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Syrou', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Comoutos', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Theodorakis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Athanasios Z', 'Initials': 'AZ', 'LastName': 'Jamurtas', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Trikala, Greece.'}]",European journal of sport science,['10.1080/17461391.2019.1663270']
1011,31581815,Bias in retrospective analyses of biomarker effect using data from an outcome-adaptive randomized trial.,"BACKGROUND/AIMS


Biomarker-stratified outcome-adaptive randomization trials, in which randomization probabilities depend on both biomarker value and outcomes of previously treated patients, are receiving increased attention in oncology research. Data from these trials can also form the basis of investigation of additional biomarkers that may not have been incorporated into the original trial design. In this article, we investigate the validity of a standard analytical method that utilizes data from a biomarker-stratified outcome-adaptive randomization trial to assess the effect of a newly identified biomarker on patient outcomes.
METHODS


In the context of an ancillary biomarker study for a two-arm phase II trial with a response endpoint, we conduct analytic and simulation studies to investigate bias in estimated biomarker effects under outcome-adaptive randomization. Conditions under which bias arises and magnitude of the bias are examined in several settings. We then propose unbiased estimators of biomarker effects with appropriate variance estimators.
RESULTS


We demonstrate that use of biomarker-stratified outcome-adaptive randomization perturbs the patient population and treatment assignments. Consequently, application of standard analysis methods to data from an outcome-adaptive randomization trial either to estimate prognostic effect of a new biomarker in uniformly treated patients or to estimate effect of treatment in relation to the new biomarker can lead to substantially biased estimates. The proposed adjusted estimators are asymptotically unbiased, and the proposed variance estimators correctly reflect the sample variability in the estimators.
CONCLUSION


This article demonstrates existence of bias when standard, naïve statistical methods are utilized to assess biomarker effects using data from a biomarker-stratified outcome-adaptive randomization trial, and hence that results from naïve analyses must be interpreted with great caution. These findings highlight that, in an era where data and specimens are increasingly being shared for biomarker studies, care must be taken to document and understand implications of the study design under which specimens or data have been obtained.",2019,"The proposed adjusted estimators are asymptotically unbiased, and the proposed variance estimators correctly reflect the sample variability in the estimators.
",[],[],[],[],[],[],,0.201167,"The proposed adjusted estimators are asymptotically unbiased, and the proposed variance estimators correctly reflect the sample variability in the estimators.
","[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McShane', 'Affiliation': 'Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Krailo', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sposto', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519875969']
1012,30857431,"Costs and Cost-Effectiveness of Targeted, Personalized Risk Information to Increase Appropriate Screening by First-Degree Relatives of People With Colorectal Cancer.","Background . Economic evaluations are less commonly applied to implementation interventions compared to clinical interventions. The efficacy of an implementation strategy to improve adherence to screening guidelines among first-degree relatives of people with colorectal cancer was recently evaluated in a randomized-controlled trial. Using these trial data, we examined the costs and cost-effectiveness of the intervention from societal and health care funder perspectives.  Method.  In this prospective, trial-based evaluation, mean costs, and outcomes were calculated. The primary outcome of the trial was the proportion of participants who had screening tests in the year following the intervention commensurate with their risk category. Quality-adjusted life years were included as secondary outcomes. Intervention costs were determined from trial records. Standard Australian unit costs for 2016/2017 were applied. Cost-effectiveness was assessed using the net benefit framework. Nonparametric bootstrapping was used to calculate uncertainty intervals (UIs) around the costs and the incremental net monetary benefit statistic.  Results . Compared with usual care, mean health sector costs were $17 (95% UI [$14, $24]) higher for those receiving the intervention. The incremental cost-effectiveness ratio for the primary trial outcome was calculated to be $258 (95% UI [$184, $441]) per additional person appropriately screened. The significant difference in adherence to screening guidelines between the usual care and intervention groups did not translate into a mean quality-adjusted life year difference.  Discussion . Providing information on both the costs and outcomes of implementation interventions is important to inform public health care investment decisions. Challenges in the application of cost-utility analysis hampered the interpretation of results and potentially underestimated the value of the intervention. Further research in the form of a modeled extrapolation of the intermediate increased adherence effect and distributional cost-effectiveness to include equity requirements is warranted.",2019,"Compared with usual care, mean health sector costs were $17 (95% UI [$14, $24]) higher for those receiving the intervention.","['first-degree relatives of people with colorectal cancer', 'People With Colorectal Cancer']",['UI'],"['costs and cost-effectiveness', 'incremental cost-effectiveness ratio', 'mean quality-adjusted life year difference', 'mean health sector costs', 'Cost-effectiveness', 'Costs and Cost-Effectiveness']","[{'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0648374,"Compared with usual care, mean health sector costs were $17 (95% UI [$14, $24]) higher for those receiving the intervention.","[{'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Doran', 'Affiliation': 'Central Queensland University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Cameron', 'Affiliation': 'Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sanson-Fisher', 'Affiliation': 'Hunter Medical Research Institute, New Lambton, New South Wales, Australia.'}, {'ForeName': 'Finlay', 'Initials': 'F', 'LastName': 'Macrae', 'Affiliation': 'University of Melbourne, Carlton, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hill', 'Affiliation': 'University of Melbourne, Carlton, Victoria, Australia.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119835294']
1013,32430896,Correction to: Endoscopic Argon Plasma Coagulation Vs. Multidisciplinary Evaluation in the Management of Weight Regain after Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,In the original article the captions for Figs. 1-3 are incorrect.,2020,1-3 are incorrect.,['after Gastric Bypass Surgery'],"['SHAM', 'Endoscopic Argon Plasma Coagulation Vs']",['Weight Regain'],"[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.102734,1-3 are incorrect.,"[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04478-4']
1014,31538887,Comparison of the Efficacy of Repaglinide Versus the Combination of Mitiglinide and Voglibose on Glycemic Variability in Japanese Patients with Type 2 Diabetes.,"BACKGROUND


Glycemic variability is a risk factor for total death and cardiovascular events. There are no obvious guidelines for the direct treatment of glycemic variability, but it can be improved with the treatment of postprandial hyperglycemia.
OBJECTIVE


We compared the effect of repaglinide versus the combination of mitiglinide and voglibose, used to improve postprandial hyperglycemia, on glycemic variability in Japanese patients with type 2 diabetes.
METHODS


We performed an open-label randomized cross-over trial between April 2016 and April 2018. Patients with type 2 diabetes who were admitted to our hospital were enrolled in our study (n = 12). Glycemic variability. was assessed using a continuous glucose monitoring system.
RESULTS


The average glucose level of the repaglinide phase (146.1 ± 20.7 mg/dl) and the combination of mitiglinide and voglibose phase (132.3 ± 19.8 mg/dl) were similar (P = 0.10). The standard division (P = 0.0005), coefficient of variation (P = 0.006), and mean amplitude of glycemic excursion (P = 0.002) of glucose were lower in the combination of mitiglinide and voglibose phase than in the repaglinide phase.
CONCLUSION


Treatment with the combination of mitiglinide and voglibose might be more effective than repaglinide for the improvement of glycemic variability.",2020,"The standard division (P = 0.0005), coefficient of variation (P = 0.006), and mean amplitude of glycemic excursion (P = 0.002) of glucose were lower in the combination of mitiglinide and voglibose phase than in the repaglinide phase.
","['Japanese patients with type 2 diabetes', 'Patients with type 2 diabetes who were admitted to our hospital were enrolled in our study (n = 12']","['repaglinide', 'mitiglinide and voglibose']","['glycemic variability', 'postprandial hyperglycemia', 'Glycemic variability', 'mean amplitude of glycemic excursion', 'average glucose level']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0906166', 'cui_str': 'mitiglinide'}, {'cui': 'C0532578', 'cui_str': '3,4-dideoxy-4-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-2-C-(hydroxymethyl)-D-epi-inositol'}]","[{'cui': 'C1855520', 'cui_str': 'Hyperglycemia, Postprandial'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",,0.0208247,"The standard division (P = 0.0005), coefficient of variation (P = 0.006), and mean amplitude of glycemic excursion (P = 0.002) of glucose were lower in the combination of mitiglinide and voglibose phase than in the repaglinide phase.
","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Diabetes and Endocrinology, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Muhei', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, Kyotamba Hospital, Kyoto, Japan.'}, {'ForeName': 'Goji', 'Initials': 'G', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Diabetes, Endocrinology, Nephrology and Rheumatology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Nakajima', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Kadono', 'Affiliation': 'Department of Diabetes, Endocrinology, Nephrology and Rheumatology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Diabetes and Endocrinology, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Hirata', 'Affiliation': 'Department of Pharmacy, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Oyamada', 'Affiliation': 'Department of Gastroenterology, Matsushita Memorial Hospital,Osaka, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Yamane', 'Affiliation': 'Department of Surgery, Matsushita Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.'}]",Current pharmaceutical design,['10.2174/1381612825666190920124853']
1015,31471444,Comparison of Taiji and aerobic exercise for functional constipation: study protocol for a randomised controlled neuroimaging trial.,"INTRODUCTION


Taiji has been proven to be effective for regulating both the physical and mental state compared with simple aerobic exercise. However, whether the improvement of Taiji for constipation is related to regulate imbalanced brain-gut axis and emotional disorder for functional constipation (FC) remains uncertain. The results of the study will demonstrate the differences in regulation brain-gut balance between Taiji and simply aerobic exercise for patients with FC and provide a potential therapy for clinical treatment of FC, and a new approach for the research of mind-body exercise.
METHODS AND ANALYSIS


In this randomised controlled neuroimaging trial, 80 patients with FC will be allocated into two groups: Taiji group and aerobic exercise group. The two groups will receive 10 weeks of Taiji exercise or aerobic exercise, respectively. The stool diary, Cleveland Constipation Score and Patient Assessment of Constipation Symptom, Patient Assessment of Constipation Quality of Life Questionnaire will be used to evaluate the clinical efficacy, the Self-rating Depression Scale, Self-rating Anxiety Scale, Eysenck Personality Questionnaires and Mini-Mental State Examinations will be used to assess the mental state at the baseline, the 5-week intervention and the end of intervention. The 24-hour heart rate variability will be used for assessing the autonomic nervous function, functional MRI and positron emission tomography-CT will be performed for detecting the cerebral functional changes at the baseline and the end of the intervention. The clinical data and multimodal imaging data will be analysed, respectively. Correlation analysis will be conducted to investigate the relationship between cerebral functional changes and symptom improvement.
ETHICS AND DISSEMINATION


The procedures have been approved by the Sichuan Regional Ethics Review Committee on Traditional Chinese Medicine (No. 2018KL-047) and conformed to the Declaration of Helsinki. Results will be disseminated through policy briefs, workshops, peer-reviewed publications and conferences.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1800019781).",2019,"The stool diary, Cleveland Constipation Score and Patient Assessment of Constipation Symptom, Patient Assessment of Constipation Quality of Life Questionnaire will be used to evaluate the clinical efficacy, the Self-rating Depression Scale, Self-rating Anxiety Scale, Eysenck Personality Questionnaires and Mini-Mental State Examinations will be used to assess the mental state at the baseline, the 5-week intervention and the end of intervention.","['80 patients with FC', 'functional constipation']","['Taiji exercise or aerobic exercise', 'Taiji group and aerobic exercise group', 'Taiji and aerobic exercise']","['clinical efficacy, the Self-rating Depression Scale, Self-rating Anxiety Scale, Eysenck Personality Questionnaires and Mini-Mental State Examinations', 'cerebral functional changes and symptom improvement', 'stool diary, Cleveland Constipation Score and Patient Assessment of Constipation Symptom, Patient Assessment of Constipation Quality of Life Questionnaire', '24-hour heart rate variability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582625', 'cui_str': 'Eysenck personality questionnaire (assessment scale)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0454845', 'cui_str': 'Cleveland (geographic location)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",80.0,0.0789078,"The stool diary, Cleveland Constipation Score and Patient Assessment of Constipation Symptom, Patient Assessment of Constipation Quality of Life Questionnaire will be used to evaluate the clinical efficacy, the Self-rating Depression Scale, Self-rating Anxiety Scale, Eysenck Personality Questionnaires and Mini-Mental State Examinations will be used to assess the mental state at the baseline, the 5-week intervention and the end of intervention.","[{'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Yuyi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Yuke', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'School of Gymnasium, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Rongtao', 'Initials': 'R', 'LastName': 'Ying', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Zhaoxuan', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'School of Chinese Classics, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China ysg@cdutcm.edu.cn wujianwei@cdutcm.edu.cn.'}, {'ForeName': 'Shu-Guang', 'Initials': 'SG', 'LastName': 'Yu', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China ysg@cdutcm.edu.cn wujianwei@cdutcm.edu.cn.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.'}]",BMJ open,['10.1136/bmjopen-2019-031089']
1016,31713060,Massage therapy reduces arterial puncture-induced pain: the randomized cross-over bi-center TORREA study.,,2020,,[],['Massage therapy'],['arterial puncture-induced pain'],[],"[{'cui': 'C3536731', 'cui_str': 'Massage Therapy'}]","[{'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0252838,,"[{'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France. sigismond@lasocki.com.""}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Moncho', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bontemps', 'Affiliation': 'Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Verger', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Anne-Charlotte', 'Initials': 'AC', 'LastName': 'Tellier', 'Affiliation': 'Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.'}, {'ForeName': 'Soizic', 'Initials': 'S', 'LastName': 'Gergaud', 'Affiliation': ""Département Anesthésie Réanimation, UBL Université d'Angers, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Ferrandière', 'Affiliation': 'Département Anesthésie Réanimation, Université de Tours, CHU de Tours, Tours, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-019-05838-0']
1017,32430879,Case presentation methods: a randomized controlled trial of the one-minute preceptor versus SNAPPS in a controlled setting.,"INTRODUCTION


One-minute preceptor (OMP) and SNAPPS (a mnemonic for Summarize history and findings; Narrow the differential; Analyze the differential; Probe the preceptor about uncertainties; Plan management; and Select case-related issues for self-study) are educational techniques developed to promote learners' expression of clinical reasoning during the case presentation in the workplace. The aim of this present study was to compare the content of the case presentation between the SNAPPS and the OMP methods.
METHODS


This was a randomized controlled trial comparing SNAPPS and OMP in 60 medical students at the beginning of their fifth year of medical school. After an introduction session, students presented and discussed two cases based on real patients and provided in written format. All case presentations were recorded and evaluated by two researchers. The assessed elements of the case presentations were divided into three subgroups related to expression of clinical reasoning, time and initiative to guide the presentation.
RESULTS


There were 30 participants in each group. There was no difference in the expression of clinical reasoning between OMP and SNAPPS groups (number of differential diagnoses, justification of most likely diagnosis and differential diagnosis, expression of comparing and contrasting hypotheses). However, students in the SNAPPS group expressed significantly more questions and uncertainties (p < 0.001), and more often took the initiative to present and justify the most likely diagnosis, differential diagnosis and management plan than students in the OMP group, both in simple and complex cases (all p values <0.001) without extending the length of the teaching session.
CONCLUSION


OMP and SNAPPS equally promote medical students' expression of clinical reasoning. The SNAPPS technique was more effective than the OMP technique in helping students to take on an active role during case presentation. We propose SNAPPS as an effective learning tool, engaging students and promoting the expression of their clinical reasoning as part of a case presentation.",2020,The SNAPPS technique was more effective than the OMP technique in helping students to take on an active role during case presentation.,['60 medical students at the beginning of their fifth year of medical school'],"['OMP technique', 'SNAPPS and OMP', 'OMP and SNAPPS', 'SNAPPS']","['expression of clinical reasoning', 'questions and uncertainties']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}]",60.0,0.0199239,The SNAPPS technique was more effective than the OMP technique in helping students to take on an active role during case presentation.,"[{'ForeName': 'Eleonora D T', 'Initials': 'EDT', 'LastName': 'Fagundes', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil. eleonoradruve@uol.com.br.'}, {'ForeName': 'Cássio C', 'Initials': 'CC', 'LastName': 'Ibiapina', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Cristina G', 'Initials': 'CG', 'LastName': 'Alvim', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Rachel A F', 'Initials': 'RAF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Marco Antônio', 'Initials': 'MA', 'LastName': 'Carvalho-Filho', 'Affiliation': 'Department of Clinical Medicine, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Paul L P', 'Initials': 'PLP', 'LastName': 'Brand', 'Affiliation': 'Center for Education Development and Research in Health Professions, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.'}]",Perspectives on medical education,['10.1007/s40037-020-00588-y']
1018,31987106,Impact of Rutin and Vitamin C combination on oxidative stress and glycemic control in patients with type 2 diabetes.,"AIM


This study aimed to investigate the effect of Vitamin C alone and in combination with Rutin on the glycemic control, insulin resistance, lipid profile and oxidative stress markers in patients with type 2 diabetes.
METHODS


A prospective, randomized, controlled study conducted on 53 type 2 diabetes patients randomized into 3 groups; (group A) 20 received Rutin with vitamin C, (group B) 20receivedvitamin C and (group C)13 received antidiabetic treatment only. Fasting Blood Glucose (FBG), Hemoglobin A1c (HbA1c), fasting insulin, Malondialdehyde, Superoxide dismutase, Lipid profile and patients' quality of life (QOL) using SF-36 questionnaire were assessed in all patients at baseline and after 8 weeks.
RESULTS


At baseline, the 3 groups were comparable while FBG was lower in group C versus group A and B (p = 0.0021). After 8 weeks, a significant reduction was observed in % change of FBG in groups A and B versus group C (p = 0.0165, 0.0388 respectively). Low Density Lipoprotien-cholesterol (LDL-c) and Total cholesterol (TC) levels significantly improved in group B versus baseline (p = 0.0239,0.0166 respectively). QOL, physical functioning and energy domains improved significantly in group A versus group C (p = 0.0049, 0.0253 respectively), while role limitation to physical health and to emotional problem improved significantly in group B versus group C (p = 0.0267,0.0280 respectively).
CONCLUSION


Vitamin C supplementation alone or with Rutin significantly reduced the % change of FBG compared to controls but had no effect on HbA1c, FBG,TC, fasting insulin and HOMA-IR or oxidative stress in T2DMpatients.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03437902.",2020,"After 8 weeks, a significant reduction was observed in % change of FBG in groups A and B versus group C (p = 0.0165, 0.0388 respectively).","['53 type 2 diabetes patients randomized into 3 groups; (group A) 20 received', 'patients with type 2 diabetes']","['Rutin and Vitamin C combination', 'Vitamin C supplementation', 'Rutin with vitamin C, (group B', 'Vitamin C alone and in combination with Rutin']","[""Fasting Blood Glucose (FBG), Hemoglobin A1c (HbA1c), fasting insulin, Malondialdehyde, Superoxide dismutase, Lipid profile and patients' quality of life (QOL) using SF-36 questionnaire"", 'FBG', 'Low Density Lipoprotien-cholesterol (LDL-c) and Total cholesterol (TC) levels', 'QOL, physical functioning and energy domains', 'oxidative stress and glycemic control', 'glycemic control, insulin resistance, lipid profile and oxidative stress markers', 'HbA1c, FBG,TC, fasting insulin and HOMA-IR or oxidative stress', 'physical health and to emotional problem']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0035976', 'cui_str': 'rutoside'}, {'cui': 'C3654014', 'cui_str': 'vitamin C combinations'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}]",53.0,0.0381264,"After 8 weeks, a significant reduction was observed in % change of FBG in groups A and B versus group C (p = 0.0165, 0.0388 respectively).","[{'ForeName': 'Sara Ramzy', 'Initials': 'SR', 'LastName': 'Ragheb', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. Electronic address: dr.sararamzy@yahoo.com.'}, {'ForeName': 'Lamia Mohamed', 'Initials': 'LM', 'LastName': 'El Wakeel', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. Electronic address: lamywak@yahoo.com.'}, {'ForeName': 'Merhan Samy', 'Initials': 'MS', 'LastName': 'Nasr', 'Affiliation': 'Internal Medicine Department, Division of Endocrinology, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: merhan_nasr@hotmail.com.'}, {'ForeName': 'Nagwa Ali', 'Initials': 'NA', 'LastName': 'Sabri', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. Electronic address: nagwa.sabri@yahoo.com.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.10.015']
1019,31678013,"Regarding the article entitled ""A smartphone application for reporting symptoms in adults with cystic fibrosis improves the detection of exacerbations: Results of a randomised controlled trial"".",,2020,,['adults with cystic fibrosis'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]",[],[],,0.180237,,"[{'ForeName': 'Zhe Hui', 'Initials': 'ZH', 'LastName': 'Hoo', 'Affiliation': 'School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK; Sheffield Adult CF Centre, Northern General Hospital, Sheffield, UK. Electronic address: z.hoo@sheffield.ac.uk.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Wildman', 'Affiliation': 'Sheffield Adult CF Centre, Northern General Hospital, Sheffield, UK; School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK. Electronic address: martin.wildman3@nhs.net.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.09.017']
1020,31831143,"Corrigendum to ""Effect of lurasidone vs olanzapine on neurotrophic biomarkers in unmedicated schizophrenia: A randomized controlled trial"" [J. Psychiatr. Res. 112 (2019) 1-6].",,2020,,"['unmedicated schizophrenia', '112']",['lurasidone vs olanzapine'],['neurotrophic biomarkers'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C4704801', 'cui_str': 'Neurotrophic'}]",,0.075146,,"[{'ForeName': 'Monalisa', 'Initials': 'M', 'LastName': 'Jena', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India. Electronic address: pharm_monalisa@aiimsbhubaneswar.edu.in.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Ranjan', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Patna, India.'}, {'ForeName': 'Biswa Ranjan', 'Initials': 'BR', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Santanu', 'Initials': 'S', 'LastName': 'Nath', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Pallabi', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Psychiatry, KIMS, Bhubaneswar, India.'}, {'ForeName': 'Bikash Ranjan', 'Initials': 'BR', 'LastName': 'Meher', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Maiti', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.11.019']
1021,29757433,The Effects of Useful Field of View Training on Brain Activity and Connectivity.,"OBJECTIVES


Useful Field of View training (UFOVt) is an adaptive computerized cognitive intervention that improves visual attention and transfers to maintained health and everyday functioning in older adults. Although its efficacy is well established, the neural mechanisms underlying this intervention are unknown. This pilot study used functional MRI (fMRI) to explore neural changes following UFOVt.
METHOD


Task-driven and resting-state fMRI were used to examine changes in brain activity and connectivity in healthy older adults randomized to 10 hr of UFOVt (n = 13), 10 hr of cognitively stimulating activities (CSA; n = 11), or a no-contact control (NC; n = 10).
RESULTS


UFOVt resulted in reduced task-driven activity in the majority of regions of interest (ROIs) associated with task performance, CSA resulted in reduced activity in one ROI, and there were no changes within the NC group. Relative to NC, UFOVt reduced activity in ROIs involved in effortful information processing. There were no other significant between-group task-based differences. Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC.
DISCUSSION


UFOVt enhances connections needed for visual attention. Together with prior work, this study provides evidence that improvement of the brain's visual attention efficiency is one mechanism underlying UFOVt.",2019,"Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC.
","['healthy older adults randomized to 10 hr of UFOVt (n = 13), 10 hr of cognitively stimulating activities (CSA; n = 11), or a no-contact control (NC; n = 10', 'older adults']","['functional MRI (fMRI', 'View Training', 'View training (UFOVt', 'Method\n\n\nTask-driven and resting-state fMRI']","['executive function and visual attention', 'Brain Activity and Connectivity', 'brain activity and connectivity', 'reduced task-driven activity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0589102', 'cui_str': 'Visual attention, function (observable entity)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",13.0,0.0373196,"Resting-state functional connectivity between ROIs involved in executive function and visual attention was strengthened following UFOVt compared with CSA and NC.
","[{'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Ross', 'Affiliation': 'Department of Human Development and Family Studies, University Park.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Whitaker', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}, {'ForeName': 'Jarrod M', 'Initials': 'JM', 'LastName': 'Hicks', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, The University of Alabama at Birmingham.'}, {'ForeName': 'Shaadee', 'Initials': 'S', 'LastName': 'Samimy', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dennis', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Visscher', 'Affiliation': 'Department of Neurobiology, The University of Alabama at Birmingham.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gby041']
1022,31800558,"Letter to the Editor Following ""Prospective Clinical Trial Comparing Outcome Measures Between Furlow and von Langenbeck Palatoplasties for UCLP"" by William N. Williams, M. Brent Seagle, Maria Ines Pegoraro-Krook, et al. Annals of Plastic Surgery, 2011.",,2020,,[],[],"['Furlow and von Langenbeck Palatoplasties for UCLP"" by William N. Williams, M. Brent Seagle, Maria Ines Pegoraro-Krook, et al']",[],[],[],,0.0242814,,"[{'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Singapore Clinical Research Institute, Singapore qingshu.lu@scri.edu.sg Department of Plastic, Reconstructive, and Aesthetic Surgery, Singapore General Hospital, Singapore. Cleft and Craniofacial Centre, KK Women's and Children Hospital, Singapore. SingHealth Duke-NUS Academic Medical Centre, Singapore. Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.""}, {'ForeName': 'Seng Teik', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Selena Ee-Li', 'Initials': 'SE', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Say Beng', 'Initials': 'SB', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Machin', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000002078']
1023,18653444,"Patients' engagement with ""Sweet Talk"" - a text messaging support system for young people with diabetes.","BACKGROUND


Guidelines for optimizing type 1 diabetes in young people advocate intensive insulin therapy coupled with personal support from the health care team. ""Sweet Talk"" is a novel intervention designed to support patients between clinic visits using text messages sent to a mobile phone. Scheduled messages are tailored to patient profiles and diabetes self-management goals, and generic messages include topical ""newsletters"" and anonymized tips from other participants. The system also allows patients to submit data and questions to the diabetes care team.
OBJECTIVES


The aim was to explore how patients with type 1 diabetes interact with the Sweet Talk system in order to understand its utility to this user group.
METHODS


Subjects were 64 young people with diabetes who were participating in the intervention arms of a randomized controlled trial. All text messages submitted to Sweet Talk during a 12-month period were recorded. Messaging patterns and content were analyzed using mixed quantitative and qualitative methods.
RESULTS


Patients submitted 1180 messages during the observation period (mean 18.4, median 6). Messaging frequency ranged widely between participants (0-240) with a subset of 5 high users contributing 52% of the total. Patients' clinical and sociodemographic characteristics were not associated with total messaging frequency, although girls sent significantly more messages unrelated to diabetes than did boys (P = .002). The content of patients' messages fell into 8 main categories: blood glucose readings, diabetes questions, diabetes information, personal health administration, social messages, technical messages, message errors, and message responses. Unprompted submission of blood glucose values was the most frequent incoming message type (35% of total). Responses to requests for personal experiences and tips generated 40% of all the incoming messages, while topical news items also generated good responses. Patients also used the service to ask questions, submit information about their self-management, and order supplies. No patients nominated supporters to receive text messages about their self-management goals. Another option that was not used was the birthday reminder service.
CONCLUSIONS


Automated, scheduled text messaging successfully engaged young people with diabetes. While the system was primarily designed to provide ""push"" support to patients, submission of clinical data and queries illustrates that it was seen as a trusted medium for communicating with care providers. Responses to the newsletters and submission of personal experiences and tips for circulation to other participants also illustrate the potential value of such interventions for establishing a sense of community. Although participants submitted relatively few messages, positive responses to the system suggest that most derived passive support from reading the messages. The Sweet Talk system could be readily adapted to suit other chronic disease models and age groups, and the results of this study may help to inform the design of future text message support interventions.",2008,"""Sweet Talk"" is a novel intervention designed to support patients between clinic visits using text messages sent to a mobile phone.","['Subjects were 64 young people with diabetes who were participating in the intervention arms of a randomized controlled trial', 'patients with type 1 diabetes interact with the', 'young people with diabetes']","['Sweet Talk system', 'Sweet Talk"" - a text messaging support system']","['blood glucose readings, diabetes questions, diabetes information, personal health administration, social messages, technical messages, message errors, and message responses', 'total messaging frequency', 'blood glucose values']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",64.0,0.0346511,"""Sweet Talk"" is a novel intervention designed to support patients between clinic visits using text messages sent to a mobile phone.","[{'ForeName': 'Victoria Louise', 'Initials': 'VL', 'LastName': 'Franklin', 'Affiliation': 'Maternal and Child Health Sciences, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Annalu', 'Initials': 'A', 'LastName': 'Waller', 'Affiliation': ''}, {'ForeName': 'Stephen Alan', 'Initials': 'SA', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pagliari', 'Affiliation': ''}]",Journal of medical Internet research,['10.2196/jmir.962']
1024,31522924,A smartphone application for reporting symptoms in adults with cystic fibrosis improves the detection of exacerbations: Results of a randomised controlled trial.,"BACKGROUND


Respiratory exacerbations impair lung function and health-related quality of life in people with CF, with delayed identification of exacerbations often resulting in worse outcomes. We developed a smartphone application (app) for adults with CF to report symptoms to the CF team, and investigated its impact on antibiotic use and other outcomes.
METHODS


Participants were randomised to intervention (use of the app weekly or sooner if symptoms had worsened) or control (usual care). The app comprised questions relating to symptoms suggestive of an exacerbation. If worsening symptoms were reported, the participant was contacted by the nurse practitioner. The primary outcome measure was the number of courses and days of intravenous (IV) antibiotics.
RESULTS


Sixty participants (29 female, aged [mean ± SD] 31 ± 9 years, FEV 1  60 ± 18% predicted) were recruited, with 29 (48%) allocated to the intervention group. Over the 12-month follow-up, there was no clear effect of the app on the number of courses of IV antibiotics (incidence rate ratio [IRR] 1; 95% confidence interval [CI] 0.6 to 1.7), however number of courses of oral antibiotics increased (IRR 1.5; 95% CI 1.0 to 2.2). The median [IQR] time to detection of exacerbation requiring oral or IV antibiotics was shorter in the intervention group compared with the control group (70 [123] vs. 141 [140] days; p = .02). No between-group differences were observed in other outcomes.
CONCLUSION


The use of an app reduced time to detect respiratory exacerbations that required antibiotics, however did not demonstrate a clear effect on the number of courses of IV antibiotics.",2020,"The use of an app reduced time to detect respiratory exacerbations that required antibiotics, however did not demonstrate a clear effect on the number of courses of IV antibiotics.","['Participants', 'adults with cystic fibrosis', 'Sixty participants (29 female, aged [mean\u202f±\u202fSD] 31\u202f±\u202f9\u202fyears, FEV 1  60\u202f±\u202f18% predicted) were recruited, with 29 (48%) allocated to the intervention group', 'people with CF', 'adults with CF to report symptoms to the CF team']","['smartphone application', 'app weekly or sooner if symptoms had worsened) or control (usual care']","['median [IQR] time to detection of exacerbation requiring oral or IV antibiotics', 'number of courses of IV antibiotics', 'detection of exacerbations', 'number of courses and days of intravenous (IV) antibiotics', 'number of courses of oral antibiotics']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]",60.0,0.412785,"The use of an app reduced time to detect respiratory exacerbations that required antibiotics, however did not demonstrate a clear effect on the number of courses of IV antibiotics.","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia; Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia; Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Putrino', 'Affiliation': 'Abilities Research Center, Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America; Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Siobhain', 'Initials': 'S', 'LastName': 'Mulrennan', 'Affiliation': 'Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Morey', 'Affiliation': 'Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Bear', 'Affiliation': 'Department of Clinical Research and Education, Child and Adolescent Health Services, Perth, Western Australia, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia. Electronic address: k.hill@curtin.edu.au.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.09.002']
1025,31897848,Correction to: Does helping mothers in multigenerational ADHD also help children in the long run? 2‑year follow‑up from baseline of the AIMAC randomized controlled multicentre trial.,The original article was missing a statement regarding a shared first authorship. The authors Julia M. Geissler and Timo D. Vloet contributed equally to the manuscript.,2020,Geissler and Timo D. Vloet contributed equally to the manuscript.,[],[],[],[],[],[],,0.0713014,Geissler and Timo D. Vloet contributed equally to the manuscript.,"[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Geissler', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany. Geissler_J@ukw.de.'}, {'ForeName': 'Timo D', 'Initials': 'TD', 'LastName': 'Vloet', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Strom', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jaite', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Graf', 'Affiliation': 'Institute of Medical Biometry and Statistics, Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Kappel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Warnke', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hennighausen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Haack-Dees', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Schneider-Momm', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rösler', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Retz', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Hänig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'von Gontard', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hohmann', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Poustka', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colla', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gentschow', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Freitag', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holtmann', 'Affiliation': 'Hospital for Child and Adolescent Psychiatry, LWL University Hospital Hamm of the Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jans', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01465-8']
1026,32432695,Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.,"Importance


Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.
Objective


To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
Design, Setting, and Participants


Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.
Interventions


The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.
Main Outcomes and Measures


Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.
Results


One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.
Conclusions and Relevance


In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.
Trial Registration


ClinicalTrials.gov Identifier: NCT03500536.",2020,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","['Adult primary care patients (N\u2009=\u2009146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score \u2009≥\u200910) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score\u2009≥\u20098) were recruited between July 17, 2018, and December 14, 2018', 'Primary Care Patients', '146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety', 'One hundred forty-six patients were included (119 of 146 were women [81.5', 'Participants\n\n\nTwo-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences', 'primary care patients']","['mobile intervention platform, IntelliCare', 'Coached Mobile App Platform']","['proportion of patients who achieved recovery (PHQ-9/GAD-7', 'anxiety', 'changes in depression (PHQ-9) and anxiety (GAD-7', 'anxiety scores', 'depression and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.149203,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Greene', 'Affiliation': 'Psychiatric Research Institute, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lieponis', 'Affiliation': 'Actualize Therapy, Inc, Chicago, Illinois.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powell', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1011']
1027,31811893,Recruitment through media and general practitioners resulted in comparable samples in an RCT on incontinence.,"OBJECTIVES


The objective of the study was to assess the impact of recruitment strategy on the baseline characteristics of patients recruited in a randomized controlled trial for treating women with urinary incontinence.
STUDY DESIGN AND SETTING


We conducted a cross-sectional analysis of baseline data from an earlier trial. Women were recruited through the media (including social media) or from participating general practices. Baseline characteristics were compared by univariate testing. Logistic regression analysis was performed to study the association between recruitment type and multiple baseline characteristics.
RESULTS


The only differences between recruitment methods were in patient age, with those recruited through the media being significantly older than those recruited through general practice. The mean age difference was 5.0 years (95% confidence interval: 2.2-7.9).
CONCLUSION


Samples recruited through the media and through case identification were largely comparable. Therefore, recruitment through the media may be a viable alternative to recruitment through primary care. This may be especially relevant for research on eHealth treatment for conditions with which patients experience barriers when seeking health care.",2020,"The only differences between recruitment methods were in patient age, with those recruited through the media being significantly older than those recruited through general practice.","['women with urinary incontinence', 'Women were recruited through the media (including social media) or from participating general practices']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]",[],[],,0.370265,"The only differences between recruitment methods were in patient age, with those recruited through the media being significantly older than those recruited through general practice.","[{'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van der Worp', 'Affiliation': 'Department General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, P.O.-Box 196, 9700 AD Groningen, The Netherlands. Electronic address: h.van.der.worp@umcg.nl.'}, {'ForeName': 'Anne M M', 'Initials': 'AMM', 'LastName': 'Loohuis', 'Affiliation': 'Department General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, P.O.-Box 196, 9700 AD Groningen, The Netherlands.'}, {'ForeName': 'Ilse L', 'Initials': 'IL', 'LastName': 'Flohil', 'Affiliation': 'Department General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, P.O.-Box 196, 9700 AD Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn J', 'Initials': 'BJ', 'LastName': 'Kollen', 'Affiliation': 'Department General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, P.O.-Box 196, 9700 AD Groningen, The Netherlands.'}, {'ForeName': 'Nienke J', 'Initials': 'NJ', 'LastName': 'Wessels', 'Affiliation': 'Department General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, P.O.-Box 196, 9700 AD Groningen, The Netherlands.'}, {'ForeName': 'Marco H', 'Initials': 'MH', 'LastName': 'Blanker', 'Affiliation': 'Department General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, P.O.-Box 196, 9700 AD Groningen, The Netherlands.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2019.12.001']
1028,31515680,Transition effects from laparocscopic to robotic surgery skills in small cavities.,"Conventional laparoscopic surgery (LS) is being challenged by the ever-increasing use of robotic surgery (RS) to perform reconstructive procedures. The purpose of this study was to assess the acquisition of skills in both techniques and the potential transfer of skills from one technique to the other when restricted spaces are involved. A preclinical randomized crossover study design was implemented. Twelve subjects performed two different reproducible drill procedures: ""Thread the Ring"" (TR) and ""Transfer the Plot"" (TP). To assess surgical proficiency in confined workspaces, these exercises were performed with LS and RS technology in a pediatric laparoscopic surgery (PLS) simulator. Each performance was recorded and evaluated by two reviewers using objective structured assessment of technical skills (OSATS). The times to complete the TP and the TR procedure were significantly shorter with RS compared to LS (64 s vs. 319 s; p < 0.0001 for both TP and TR). A significant transfer effect of skills between LS and RS was noted for the TP exercise (p = 0.006). The percentage improvement was greater overall with LS, meaning a higher number of trials were required to adequately master the procedure. This study demonstrated that RS performed significantly better compared to LS on pediatric simulation devices. A transfer effect was identified from LS to RS exclusively. The learning curves showed that progression was definitely longer with LS. These results, indicate that novice surgeons should be encouraged to persist with learning LS, and they support the use of a pediatric robotic simulation device.",2020,A significant transfer effect of skills between LS and RS was noted for the TP exercise (p = 0.006).,"['Twelve subjects performed two different reproducible drill procedures', 'small cavities']","['Conventional laparoscopic surgery (LS', 'robotic surgery (RS', 'pediatric laparoscopic surgery (PLS) simulator', 'Thread the Ring"" (TR) and ""Transfer the Plot"" (TP']","['times to complete the TP and the TR procedure', 'TP exercise']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0324815', 'cui_str': 'Drill'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",12.0,0.0200835,A significant transfer effect of skills between LS and RS was noted for the TP exercise (p = 0.006).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Moncayo', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Compagnon', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Caire', 'Affiliation': 'Service de Neurochirurgie, Hôpital Dupuytren, 2 Avenue Martin Luther King, 87042, Limoges Cedex, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grosos', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bahans', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ilhero', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fourcade', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Ballouhey', 'Affiliation': 'Service de Chirurgie Viscérale Pédiatrique, Hôpital des Enfants, 8 Avenue Dominique Larrey, 87042, Limoges Cedex, France. q.ballouhey@gmail.com.'}]",Journal of robotic surgery,['10.1007/s11701-019-01024-y']
1029,31524645,"Effects of Massage and Acupressure on Relieving Labor Pain, Reducing Labor Time, and Increasing Delivery Satisfaction.","BACKGROUND


Several recent studies have documented the effects of massage and acupressure in reducing labor pain and labor time and in satisfaction with the delivery. However, few studies have investigated the comparative effects of these two therapies.
PURPOSE


The aim of this study was to compare the effects of massage and acupressure on labor-related pain management, duration, and satisfaction with delivery.
METHODS


This randomized controlled trial (n = 120) included three intervention groups (massage only, acupressure only, and massage + acupressure) and one control group, in which patients received no massage or acupressure treatment. A personal information form, Pregnant Watch Form, and Visual Analog Scale (VAS) were used to collect data. Frequency and percentage calculations, chi-square test, Student's t test, Tukey's honestly significant difference test, and one-way variance analysis were used for data analysis.
RESULTS


In the latent phase of labor, the mean VAS scores of the massage-only group and massage + acupressure group were lower (4.56 ± 1.36 and 4.63 ± 1.52, respectively) than that of the control group (6.16 ± 1.46; p < .01). In the active and transition phases, the mean VAS scores of the massage-only group, acupressure-only group, and massage + acupressure group were significantly lower than that of the control group (p < .01 and p < .001, respectively). During postpartum, the mean VAS score of the massage + acupressure group was lower (2.30 ± 0.70) than that of the control group (2.96 ± 0.72; p = .003). Cervical dilatation completion time and 1- and 5-minute Apgar scores were similar among all of the groups (p > .05). The three intervention groups reported relatively more positive feelings than the control group, and all three of the interventions were found to be effective in improving satisfaction.
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


The results of this study indicate that the dual application of massage and acupressure is relatively more effective than either therapy applied alone and that massage is more effective than acupressure.",2020,Cervical dilatation completion time and 1- and 5-minute Apgar scores were similar among all of the groups (p > .05).,[],"['Massage and Acupressure', 'no massage or acupressure treatment', 'massage and acupressure', 'intervention groups (massage only, acupressure only, and massage + acupressure', 'massage + acupressure']","['Cervical dilatation completion time and 1- and 5-minute Apgar scores', 'labor-related pain management, duration, and satisfaction with delivery', 'Visual Analog Scale (VAS', 'mean VAS scores', 'Relieving Labor Pain, Reducing Labor Time, and Increasing Delivery Satisfaction', 'positive feelings', 'mean VAS score', 'labor pain and labor time', 'satisfaction']",[],"[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0079103', 'cui_str': 'Cervical Dilatation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0244177,Cervical dilatation completion time and 1- and 5-minute Apgar scores were similar among all of the groups (p > .05).,"[{'ForeName': 'Ilknur Munevver', 'Initials': 'IM', 'LastName': 'Gönenç', 'Affiliation': ''}, {'ForeName': 'Füsun', 'Initials': 'F', 'LastName': 'Terzioğlu', 'Affiliation': 'PhD, RN, Professor, Faculty of Health Sciences, Department of Nursing, Atilim University, Ankara, Turkey.'}]",The journal of nursing research : JNR,['10.1097/jnr.0000000000000344']
1030,31834099,"No Influence of Low-, Medium-, or High-Dose Tyrosine on Exercise in a Warm Environment.","PURPOSE


Tyrosine administration may counter exercise fatigue in a warm environment, but the typical dose is inconclusive, with little known about higher doses. We explored how three tyrosine doses influenced the circulating ratio of tyrosine/amino acids competing for brain uptake and hypothesized that a medium and high dose would enhance exercise performance in a warm environment.
METHODS


Eight recreationally trained, non-heat-acclimated male individuals (mean ± SD age, 23 ± 4 yr; stature, 181 ± 7 cm; body mass, 76.1 ± 5.9 kg; peak oxygen uptake, 4.1 ± 0.5 L·min) performed a peak oxygen uptake test, two familiarization trials, then four experimental trials in a randomized order separated by 7 d. Before exercise, subjects drank 2 × 300 mL sugar-free drinks delivering 0 (PLA), 150 (LOW), 300 (MED), or 400 (HIGH) mg·kg body mass tyrosine in a double-blind fashion. Subjects performed a 60-min constant intensity cycling then a simulated time trial in 30°C and 60% relative humidity.
RESULTS


Time trial performance (P = 0.579) was not influenced by tyrosine ingestion. The plasma ratio of tyrosine/∑(free-tryptophan, leucine, isoleucine, valine, phenylalanine, methionine), a key determinant of brain tyrosine influx, increased relative to PLA (P < 0.001). The increase was similar (P > 0.05) in MED (7.7-fold) and HIGH (8.2-fold), and greater than that in LOW (5.3-fold; P < 0.05). No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
CONCLUSION


Exercise performance in a warm environment was not influenced by tyrosine availability in recreationally trained male individuals. The results provide novel data informing future studies, on the tyrosine dose maximizing the circulating ratio of tyrosine/amino acids competing for brain uptake.",2020,"No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
","['recreationally trained male individuals', 'Eight recreationally trained, non-heat-acclimated male individuals (mean ± SD age, 23 ± 4 yr; stature, 181 ± 7 cm; body mass, 76.1 ± 5.9 kg; peak oxygen uptake, 4.1 ± 0.5 L·min) performed a peak oxygen uptake test, two familiarization trials']","['Low-, Medium-, or High-Dose Tyrosine', 'subjects drank 2 × 300 mL sugar-free drinks delivering 0 (PLA), 150 (LOW), 300 (MED), or 400 (HIGH) mg·kg body mass tyrosine in a double-blind fashion']","['core and skin temperature, heart rate, RPE, or thermal sensation', 'plasma ratio of tyrosine/∑(free-tryptophan, leucine, isoleucine, valine, phenylalanine, methionine), a key determinant of brain tyrosine influx']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0022192', 'cui_str': 'Isoleucine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}]",8.0,0.149914,"No differences existed between trials in core and skin temperature, heart rate, RPE, or thermal sensation (P > 0.05).
","[{'ForeName': 'Les', 'Initials': 'L', 'LastName': 'Tumilty', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Wales, UNITED KINGDOM.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gregory', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': ''}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Thatcher', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002245']
1031,32088134,"Accuracy, inter-observer and intra-observer reliability in topography assessment of multifocal contact lens centration.","PURPOSE


To evaluate the accuracy and reliability (inter and intra-observer) of a method to assess multifocal contact lenses (MCLs) centration using a corneal topography unit.
METHOD


Daily-disposable MCLs (Fusion 1 day Presbyo) were fitted on both eyes of the subjects. For each lens fit a slit lamp digital picture and videokeratograph image were taken in a rapid but randomised sequence. Photo-editing software was used to assess the position of the MCL centre with respect to pupil centre as taken from the slit lamp photograph. The position of the MCL centre was automatically detected as the point of maximum curvature from the videokeratography. Three further manual and qualitative procedures to detect MCL centre, comparing a template of CLs optic zones to the videokeratographic image were performed by 4 practitioners using 3 different algorithms to represent the topographic map. Each manual reading was repeated 3 times.
RESULTS


Twenty-two subjects (11 males) aged 22.8 ± 1.9 years (range 20.8-27.0 years) were recruited. The accuracy of the 4 topographic assessments in determining the centre coordinates of the MCL with respect to SL assessment was good: no differences were found in the left eyes and although in the right eyes a more temporal and superior position of MCLs was determined (paired t-test, p < 0.05) the difference was clinically negligible (0.16 ± 0.36 mm horizontally, 0.23 ± 0.48 vertically). Amongst the 4 practitioners one-way Anova for repeated measures showed no differences for any of the 3 manual assessments. Intra-class correlation coefficient was calculated among the 3 readings for each manual procedure and was very good (between 0.75 and 0.98) in 3 practitioners and moderate (between 0.49 and 0.92) in the fourth.
CONCLUSIONS


The assessment of MCL centration by performing corneal topography over the MCL is an accurate method. Furthermore, inter and intra-practitioner reliability showed by manual procedures appeared very good.",2020,Amongst the 4 practitioners one-way Anova for repeated measures showed no differences for any of the 3 manual assessments.,['Twenty-two subjects (11 males) aged 22.8 ± 1.9 years (range 20.8-27.0 years) were recruited'],"['multifocal contact lenses (MCLs) centration', 'Daily-disposable MCLs']","['temporal and superior position of MCLs', 'Intra-class correlation coefficient', 'Accuracy, inter-observer and intra-observer reliability']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026691', 'cui_str': 'Kawasaki Syndrome'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0026691', 'cui_str': 'Kawasaki Syndrome'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",22.0,0.0130263,Amongst the 4 practitioners one-way Anova for repeated measures showed no differences for any of the 3 manual assessments.,"[{'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Zeri', 'Affiliation': 'University of Milano Bicocca, Department of Materials Science, via R. Cozzi 55, I-20125 Milan, Italy; University of Milano Bicocca, COMiB Research Centre in Optics and Optometry, via R. Cozzi 55, I-20125 Milan, Italy; School of Life and Health Sciences, Aston University, Birmingham, UK. Electronic address: fabrizio.zeri@unimib.it.'}, {'ForeName': 'Assunta', 'Initials': 'A', 'LastName': 'Di Vizio', 'Affiliation': 'Degree Course in Optics and Optometry, Department of Sciences, Roma TRE University, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guida', 'Affiliation': 'Degree Course in Optics and Optometry, Department of Sciences, Roma TRE University, Rome, Italy.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Rotondi', 'Affiliation': 'Degree Course in Optics and Optometry, Department of Sciences, Roma TRE University, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Tavazzi', 'Affiliation': 'University of Milano Bicocca, Department of Materials Science, via R. Cozzi 55, I-20125 Milan, Italy; University of Milano Bicocca, COMiB Research Centre in Optics and Optometry, via R. Cozzi 55, I-20125 Milan, Italy.'}, {'ForeName': 'Shehzad A', 'Initials': 'SA', 'LastName': 'Naroo', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.02.008']
1032,17378819,A randomised trial of two methods of issuing prenatal test results: the ARIA (Amniocentesis Results: Investigation of Anxiety) trial.,"BACKGROUND


Many pregnant women experience anxiety while waiting for the results of diagnostic tests. Policies and practices intended to reduce this anxiety require evaluation.
OBJECTIVES


To test the following two hypotheses: * That giving amniocentesis results out on a fixed date alters maternal anxiety during the waiting period, compared with a policy of telling parents that the result will be issued ""when available"" (i.e. variable date). * That issuing early results from a rapid molecular test alters maternal anxiety during the waiting period, compared with not receiving any results prior to the karyotype. The effects of the two interventions on anxiety 1 month after receiving karyotype results were also examined.
DESIGN


A multicentre, randomised, controlled, open fixed sample, 2 x 2 factorial design trial, with equal randomisation.
SETTING


The prenatal diagnosis clinics in 12 hospitals in England offering amniocentesis as a diagnostic test for Down's syndrome.
SAMPLE


Two hundred and twenty-six women who had had an amniocentesis were randomised between June 2002 and July 2004. Eight women with abnormal results or test failure were excluded post-randomisation.
INTERVENTIONS


Issuing karyotype results on a prespecified fixed date, rather than issuing them as soon as they became available. Issuing karyotype results alone, or subsequent to issuing results from a rapid molecular test for the most common chromosomal abnormalities.
MAIN OUTCOME MEASURES


Average anxiety during the waiting period, calculated using daily scores from the short version of the Spielberger State-Trait Anxiety Inventory (STAI). Anxiety 1 month after receiving karyotype results, measured using the short form STAI.
RESULTS


Issuing early results from a partial but rapid test reduced maternal anxiety by a clinically significant amount during the waiting period (mean daily score 12.5 versus 14.8; scale score difference -2.36, 95% CI -1.2, -3.6), compared with receiving only the full karyotype results. There was no evidence that giving out karyotype results on a fixed or on a variable date altered maternal anxiety during the waiting period (mean daily score 13.2 versus 14.2; scale score difference -1.02, 95% CI -2.2, 0.2). One month after receiving normal karyotype results, anxiety was low in all groups, but women who had been given rapid test results tended to be more anxious than those who had not (mean single day score 9.2 versus 8.3; mean scale score difference 0.95, 95% CI -0.03, 1.9). This small to moderate effect did not reach conventional levels of statistical significance.
CONCLUSIONS


Rapid testing was a beneficial addition to karyotyping, at least in the short term. This does not necessarily imply that early results would be preferred to comprehensive ones if women had to choose between them. Because there are no clear advantages in anxiety terms of issuing karyotype results as soon as they become available, or on a fixed date, women could be given a choice between them.",2007,"RESULTS


Issuing early results from a partial but rapid test reduced maternal anxiety by a clinically significant amount during the waiting period (mean daily score 12.5 versus 14.8; scale score difference -2.36, 95% CI -1.2, -3.6), compared with receiving only the full karyotype results.","[""The prenatal diagnosis clinics in 12 hospitals in England offering amniocentesis as a diagnostic test for Down's syndrome"", 'Two hundred and twenty-six women who had had an amniocentesis were randomised between June 2002 and July 2004', 'Eight women with abnormal results or test failure were excluded post-randomisation']",['ARIA '],"['Spielberger State-Trait Anxiety Inventory (STAI', 'maternal anxiety', 'anxiety', 'Average anxiety']","[{'cui': 'C0033053', 'cui_str': 'Intrauterine Diagnosis'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}, {'cui': 'C0086143'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0459424', 'cui_str': 'Abnormal result (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C3495884', 'cui_str': 'Amyloid related imaging abnormalities'}]","[{'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",8.0,0.121427,"RESULTS


Issuing early results from a partial but rapid test reduced maternal anxiety by a clinically significant amount during the waiting period (mean daily score 12.5 versus 14.8; scale score difference -2.36, 95% CI -1.2, -3.6), compared with receiving only the full karyotype results.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hewison', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Leeds, Leeds, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fountain', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hawkins', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mason', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morley', 'Affiliation': ''}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Thornton', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,[]
1033,32081289,Muscle Complaints or Events in Patients Randomized to Simvastatin or Ezetimibe/Simvastatin.,,2020,,[],['Simvastatin or Ezetimibe/Simvastatin'],[],[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1532737', 'cui_str': 'ezetimibe / Simvastatin'}]",[],,0.0163499,,"[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Nanna', 'Affiliation': ''}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': ''}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ''}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': ''}, {'ForeName': 'Yale B', 'Initials': 'YB', 'LastName': 'Mitchel', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Musliner', 'Affiliation': ''}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Blazing', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.12.022']
1034,32428840,Acute effects of time-restricted feeding in low-income women with obesity placed on hypoenergetic diets: Randomized trial.,"OBJECTIVE


The aim of this study was to evaluate the acute effects of time-restricted feeding in obese women living in social vulnerability who were placed on diets with the same energy deficit.
METHODS


Fifty-eight obese women (19-44 y of age) were randomized to a group with a hypoenergetic diet and 12 h of fasting daily or to a group with only a hypoenergetic diet for 21 d, with body weight and waist circumference monitoring up to 81 d of intervention. The determination of the individual's energy content of the diets was based on their resting metabolic rate (by indirect calorimetry) and physical activity level (by triaxial accelerometers). Body composition, temperature, blood pressure, appetite, adhesion difficulty, thyroid axis hormones, leptin, glucose concentration, and insulin were measured before and after 21 d of intervention. A mixed analysis of variance test was performed.
RESULTS


The women had a mean age of 31 y and mean body mass index of 33 kg/m². Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group. Also, there was a significant decrease in waist circumference in the time-restricted feeding group after 81 d. There were no differences in hormonal profile, resting metabolic rate, reported appetite, or adherence difficulty.
CONCLUSION


Time-restricted feeding may be considered an alternative strategy for treating obesity in socially vulnerable women.",2020,"Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group.","['obese women living in social vulnerability who were placed on diets with the same energy deficit', 'low-income women with obesity placed on hypoenergetic diets', 'women had a mean age of 31 y and mean body mass index of 33 kg/m²', 'socially vulnerable women', 'Fifty-eight obese women (19-44 y of age']","['time-restricted feeding', 'hypoenergetic diet and 12 h of fasting daily or to a group with only a hypoenergetic diet']","['resting metabolic rate (by indirect calorimetry) and physical activity level', 'Body composition, temperature, blood pressure, appetite, adhesion difficulty, thyroid axis hormones, leptin, glucose concentration, and insulin', 'waist circumference', 'axillary temperature', 'hormonal profile, resting metabolic rate, reported appetite, or adherence difficulty', 'body fat']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1531924', 'cui_str': 'Axillary temperature'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",58.0,0.0653357,"Significant interaction between group × time was observed only in axillary temperature (0.44°C; 95% confidence interval [CI], 0.17-0.74°C; P < 0.01), which increased in the experimental group and in body fat (-0.75%; 95% CI, -1.43% to -0.07%; P = 0.02) decreased in the experimental group.","[{'ForeName': 'Isabele R O M', 'Initials': 'IROM', 'LastName': 'Pureza', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: isabelemaranhaonut@hotmail.com.'}, {'ForeName': 'Ingrid S V', 'Initials': 'ISV', 'LastName': 'Melo', 'Affiliation': 'Instituto Federal de Alagoas, Alagoas, Brazil. Electronic address: ingrid.melo@ifal.edu.br.'}, {'ForeName': 'Mateus L', 'Initials': 'ML', 'LastName': 'Macena', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: m.l.macena@hotmail.com.'}, {'ForeName': 'Dafiny R S', 'Initials': 'DRS', 'LastName': 'Praxedes', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: dafiny_rodrigues96@hotmail.com.'}, {'ForeName': 'Laís G L', 'Initials': 'LGL', 'LastName': 'Vasconcelos', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: laisglv@gmail.com.'}, {'ForeName': 'André E', 'Initials': 'AE', 'LastName': 'Silva-Júnior', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: andreeduardojr@hotmail.com.'}, {'ForeName': 'Telma M M T', 'Initials': 'TMMT', 'LastName': 'Florêncio', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: telmatf_al@hotmail.com.'}, {'ForeName': 'Nassib B', 'Initials': 'NB', 'LastName': 'Bueno', 'Affiliation': 'Faculdade de Nutrição (FANUT) - Universidade Federal de Alagoas (UFAL), Campus AC Simões, Cidade Universitária, Maceió, Alagoas, Brazil. Electronic address: nassib.bueno@fanut.ufal.br.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110796']
1035,30327302,"PTEN Expression, Not Mutation Status in  TSC1, TSC2 , or  mTOR , Correlates with the Outcome on Everolimus in Patients with Renal Cell Carcinoma Treated on the Randomized RECORD-3 Trial.","PURPOSE


Genomic alterations in key components of PI3K/mTOR pathway have been proposed as candidate predictive markers for rapalog therapy in renal cell carcinoma (RCC). We tested this hypothesis in patients from a randomized phase II trial of everolimus versus sunitinib.
PATIENTS AND METHODS


Archival specimens collected at baseline were analyzed with targeted next-generation sequencing (NGS). Focus of interest were alterations in key PI3K pathway components. PTEN expression was assessed by IHC. Association between molecular findings and treatment outcomes was investigated; same associations were tested for 2 everolimus-treated trial cohorts in gastric and hepatocellular carcinoma (HCC).
RESULTS


Among 184 everolimus-treated patients with RCC with NGS data, mutation rates in genes of interest were 6% ( TSC1 ), 4.4% ( TSC2 ), and 8.2% ( mTOR ); 44% harbored alterations in ≥1 PI3K pathway component. For subjects with presence versus absence of mutations in  TSC1, TSC2 , or  mTOR  progression-free survival (PFS) neither differed on univariate analysis (HR, 1.0;  P  = 0.895) nor on multivariate testing stratified by MSKCC risk group and other established prognostic factors (HR, 1.1;  P  = 0.806). Everolimus-treated patients with retained ( n  = 50) versus lost ( n  = 50) PTEN IHC expression had median PFS of 5.3 months versus 10.5 months (HR, 2.5;  P  < 0.001). Such differences were not seen with sunitinib (10.9 months vs. 10.3 months; HR, 0.8;  P  = 0.475). Molecular findings did not correlate with outcomes in gastric and HCC cohorts.
CONCLUSIONS


Association between mutation status for  TSC1 / TSC2 / mTOR  and therapeutic outcome on everolimus was not confirmed. Clinically meaningful differences in PFS were seen based on PTEN expression by IHC, lost in >50% of patients.",2019,"Such differences were not seen with sunitinib (10.9 months vs. 10.3 months; HR, 0.8;  P  = 0.475).","['Archival specimens collected at baseline were analyzed with targeted next-generation sequencing (NGS', 'Patients with Renal Cell Carcinoma', 'renal cell carcinoma (RCC']","['everolimus versus sunitinib', 'Everolimus']","['TSC1 / TSC2 / mTOR  and therapeutic outcome on everolimus', 'median PFS', 'PTEN expression']","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.0535662,"Such differences were not seen with sunitinib (10.9 months vs. 10.3 months; HR, 0.8;  P  = 0.475).","[{'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Voss', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York. vossm@mskcc.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Novartis Oncology, East Hanover, New Jersey.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Reising', 'Affiliation': 'Novartis Oncology, East Hanover, New Jersey.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Novartis Oncology, East Hanover, New Jersey.'}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Bristol-Myers Squibb Company, Hopewell township, New Jersey.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Ostrovnaya', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Venkatraman E', 'Initials': 'VE', 'LastName': 'Seshan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Almedina', 'Initials': 'A', 'LastName': 'Redzematovic', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Ying-Bei', 'Initials': 'YB', 'LastName': 'Chen', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Novartis Oncology, East Hanover, New Jersey.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Novartis Oncology, East Hanover, New Jersey.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Hsieh', 'Affiliation': 'Washington University, St. Louis, Missouri.'}, {'ForeName': 'A Ari', 'Initials': 'AA', 'LastName': 'Hakimi', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-1833']
1036,32127657,Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC).,"This study (NCT01288573) investigated plerixafor's safety and efficacy in children with cancer. Stage 1 investigated the dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor + standard mobilization (G-CSF ± chemotherapy). The stage 2 primary endpoint was successful mobilization (doubling of peripheral blood CD34+ cell count in the 24 h prior to first apheresis) in patients treated with plerixafor + standard mobilization vs. standard mobilization alone. In stage 1, three patients per age group (2-<6, 6-<12, and 12-<18 years) were treated at each dose level (160, 240, and 320 µg/kg). Based on PK and PD data, the dose proposed for stage 2 was 240 µg/kg (patients 1-<18 years), in which 45 patients were enrolled (30 plerixafor arm, 15 standard arm). Patient demographics and characteristics were well balanced across treatment arms. More patients in the plerixafor arm (24/30, 80%) met the primary endpoint of successful mobilization than in the standard arm (4/14, 28.6%, p = 0.0019). Adverse events reported as related to study treatment were mild, and no new safety concerns were identified. Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.",2020,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"['children with cancer', 'pediatric patients with solid tumors eligible for autologous transplants', 'pediatric cancer patients']","['Plerixafor combined with standard regimens', 'Plerixafor', 'plerixafor']","['successful mobilization', 'successful mobilization (doubling of peripheral blood CD34+ cell count', 'Adverse events', 'dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor\u2009+\u2009standard mobilization', 'tolerated and efficacious']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}]","[{'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",45.0,0.045626,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women's and Children's Hospital, Birmingham, UK. bruce.morland@nhs.net.""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kepak', 'Affiliation': 'University Hospital Brno and ICRC/St. Anna University Hospital, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Dallorso', 'Affiliation': 'IRCCS Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sevilla', 'Affiliation': 'Hospital Infantil Universitario Niño Jesus, FIB HIUNJ, CIBERER, Madrid, Spain.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': 'Royal Hospital for Children, Glasgow, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Luksch', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Yaniv', 'Affiliation': ""Schneider Children's Medical Center of Israel, Tel Aviv University, Petah Tikva, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': 'Universitätsklinikum Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Rößler', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Department for Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Maecker-Kolhoff', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': ""University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'C Michel', 'Initials': 'CM', 'LastName': 'Zwaan', 'Affiliation': ""Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sumerauer', 'Affiliation': 'Faculty Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'Kriván', 'Affiliation': 'United St Istvan and St Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bernard', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Doyle', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': ""IRCCS Bambino Gesù Children's Hospital, Rome, Italy.""}]",Bone marrow transplantation,['10.1038/s41409-020-0836-2']
1037,32077305,Join the Commune: A Controlled Study of Social Branding Influencers to Decrease Smoking Among Young Adult Hipsters.,"PURPOSE


To evaluate the impact of a Social Branding intervention in bars and nightclubs on smoking behavior.
DESIGN


Quasi-experimental controlled study.
SETTING


Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control).
PARTICIPANTS


""Hipster"" young adults (age 18-26) attending bars and nightclubs.
INTERVENTION


Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media.
MEASURES


A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018. The primary outcome was current smoking.
ANALYSIS


Multivariable logistic regression assessed correlates of smoking, adjusting for covariates including electronic cigarette use; differences between cities were evaluated using location-by-time interactions.
RESULTS


Smoking in San Francisco decreased at a significantly faster rate (51.1%-44.1%) than Los Angeles (45.2%-44.5%) ( P  = .034). Smoking in San Diego (mean: 39.6%) was significantly lower than Los Angeles (44.8%,  P  < .001) at both time points with no difference in rate of change. Brand recall was not associated with smoking behavior, but recall was associated with anti-tobacco attitudes that were associated with smoking.
CONCLUSION


This is the first controlled study of Social Branding interventions. Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.",2020,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"['Young Adult Hipsters', 'Hipster"" young adults (age 18-26) attending bars and nightclubs', 'A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018', 'Join the Commune', 'Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control']","['Social Branding intervention', 'Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media']","['smoking (San Francisco) and sustained lower smoking (San Diego', 'faster rate', 'current smoking', 'Smoking in San Francisco']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0442567', 'cui_str': 'Nightclub (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",7240.0,0.0214507,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"[{'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Ling', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, 8785University of California, San Francisco, CA, USA.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, 8785University of California, San Francisco, CA, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, 8785University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Jordan', 'Affiliation': 'Rescue Agency, San Diego, CA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120904917']
1038,31833849,Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients.,"BACKGROUND


Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247).
METHODS


Treatment-naive, HIV-1-positive adults [screening plasma viral load ≥1000 copies/ml; CD4 cell count >50 cells/μl) were randomized (1 : 1) to D/C/F/TAF (N = 362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) (N = 363) over at least 48 weeks. After week 48, patients could continue on or switch to D/C/F/TAF in an open-label extension phase until week 96.
RESULTS


At week 96, D/C/F/TAF exposure was 626 patient-years (D/C/F/TAF arm) and 109 patient-years (control arm post switch), week 96 virologic suppression (viral load <50 copies/ml; FDA-Snapshot, from baseline) was 85.1% (308/362) (D/C/F/TAF) and 83.7% (304/363) (control). Week 96 virologic failure (viral load ≥50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively. No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs) were observed post baseline. In one patient in each arm, an M184I and/or V RAM was detected. Few adverse event-related discontinuations (3% D/C/F/TAF; <1% control post switch) and no deaths occurred on D/C/F/TAF. Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the control arm post switch. Increases in total-cholesterol/high-density-lipoprotein--cholesterol rtio at week 96 were +0.25 versus baseline (D/C/F/TAF) and +0.24 versus switch (control).
CONCLUSION


At week 96, D/C/F/TAF resulted in high virologic response and low virologic failure rates, with no resistance development to darunavir or TAF/TDF. Bone, renal and lipid safety were consistent with known D/C/F/TAF component profiles. Control arm safety post switch was consistent with the D/C/F/TAF arm. AMBER week 96 results confirm the efficacy, high barrier to resistance and bone/renal safety benefits of D/C/F/TAF for treatment-naive patients.",2020,"Week 96 virologic failure (viral load ≥50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively.","['Treatment-naive, HIV-1-positive adults [screening plasma viral load ≥1000\u200acopies/ml; CD4 cell count >50\u200acells/μl) were randomized ', 'treatment-naive HIV-1 patients']","['darunavir/cobicistat/emtricitabine/tenofovir alafenamide', 'D/C/F/TAF (N\u200a=\u200a362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF', 'Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF']","['efficacy, high barrier to resistance and bone/renal safety benefits', 'Improved renal and bone parameters', 'No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs', 'Bone, renal and lipid safety', 'total-cholesterol/high-density-lipoprotein--cholesterol rtio', 'deaths', 'virologic response and low virologic failure rates']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine / tenofovir alafenamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2929052', 'cui_str': 'emtricitabine / tenofovir disoproxil'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}]",,0.0799498,"Week 96 virologic failure (viral load ≥50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Department of Infection and Immunity, Queen Mary University, London, UK.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'Department of Medicine, The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rockstroh', 'Affiliation': 'Department of Medicine I, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': ""Infectious Diseases Department, IDIBELL-Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Esser', 'Affiliation': 'Department of Dermatology and Venerology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vandekerckhove', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Ghent University and Ghent University Hospital, Ghent.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Van Landuyt', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Lathouwers', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Hufkens', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jezorwski', 'Affiliation': 'Janssen Research & Development, Pennington, New Jersey, USA.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Opsomer', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002463']
1039,32088018,Predictors of oral rotavirus vaccine immunogenicity in rural Zimbabwean infants.,"BACKGROUND


Oral rotavirus vaccines (RVV) have poor immunogenicity in low-income countries, for reasons that remain unclear. This study identified the determinants of RVV immunogenicity among infants in rural Zimbabwe.
METHODS


Anti-rotavirus IgA titres were measured among a sub-group of infants enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial (NCT01824940). SHINE was a cluster-randomized trial of improved infant and young child feeding, and improved water, sanitation and hygiene (WASH) in two rural Zimbabwean districts. Infants received RVV as part of the national immunisation programme. Among HIV-unexposed infants in the non-WASH trial arms, we evaluated associations between potential risk factors (vaccine schedule and dose, maternal and infant nutritional status, infant diarrhoea, and household environment) and RVV immunogenicity (seroconversion, seropositivity and geometric mean titres) using multivariable regression.
RESULTS


Among 219 infants with seroconversion data, 43 (20%) successfully seroconverted and 176 (80%) failed to seroconvert to RVV. Seroconversion was positively associated with a higher length-for-age Z-score (LAZ) around the time of vaccination (adjusted RR 1.27 (95% CI 1.04, 1.55), P = 0.021), and negatively associated with concurrent OPV and RVV administration (adjusted RR 0.36 (0.19, 0.71), P = 0.003). Among 472 infants with post-vaccination titres, a higher LAZ score was associated with increased seropositivity (aRR 1.21 (95% CI 1.06, 1.38), P = 0.004), and higher birthweight was associated with increased IgA titres (0.45 (95%CI 0.18, 1.09) U/mL greater per 100 g gain in birthweight; P = 0.001).
CONCLUSIONS


Infant ponderal and linear growth were positively associated with RVV immunogenicity, while concurrent administration of OPV was negatively associated with RVV immunogenicity. Together, these findings suggest that improving foetal growth and separating RVV and OPV administration are plausible approaches to increasing RVV immunogenicity.",2020,"Among 472 infants with post-vaccination titres, a higher LAZ score was associated with increased seropositivity (aRR 1.21 (95% CI 1.06, 1.38), P = 0.004), and higher birthweight was associated with increased IgA titres (0.45 (95%CI 0.18, 1.09)","['rural Zimbabwean infants', '472 infants with post-vaccination titres', 'Anti-rotavirus IgA titres were measured among a sub-group of infants enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial (NCT01824940', 'two rural Zimbabwean districts', '219 infants with seroconversion data, 43 (20%) successfully seroconverted and 176 (80%) failed to seroconvert to RVV', 'infants in rural Zimbabwe']",['rotavirus vaccines (RVV'],"['oral rotavirus vaccine immunogenicity', 'LAZ score', 'seropositivity', 'water, sanitation and hygiene (WASH', 'IgA titres', 'Seroconversion', 'potential risk factors (vaccine schedule and dose, maternal and infant nutritional status, infant diarrhoea, and household environment) and RVV immunogenicity (seroconversion, seropositivity and geometric mean titres', 'RVV immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0021279', 'cui_str': 'Infant Nutrition Physiology'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C0035870', 'cui_str': 'Rotavirus'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",472.0,0.173359,"Among 472 infants with post-vaccination titres, a higher LAZ score was associated with increased seropositivity (aRR 1.21 (95% CI 1.06, 1.38), P = 0.004), and higher birthweight was associated with increased IgA titres (0.45 (95%CI 0.18, 1.09)","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Church', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe; Centre for Genomics & Child Health, Blizard Institute, Queen Mary University of London, UK. Electronic address: j.church@qmul.ac.uk.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rukobo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Govha', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Vaccine Testing Center, Department of Pediatrics, Larner College of Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'Vaccine Testing Center, Department of Microbiology & Molecular Genetics, Larner College of Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Florence D', 'Initials': 'FD', 'LastName': 'Majo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Naume V', 'Initials': 'NV', 'LastName': 'Tavengwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, Department of Microbiology & Molecular Genetics, Larner College of Medicine, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe; Centre for Genomics & Child Health, Blizard Institute, Queen Mary University of London, UK; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: a.prendergast@qmul.ac.uk.'}]",Vaccine,['10.1016/j.vaccine.2020.01.097']
1040,31892500,Advertising Placement in Digital Game Design Influences Children's Choices of Advertised Snacks: A Randomized Trial.,"BACKGROUND


Children are inhabitants of a media-rich environment rife in extensive, sophisticated, and persistent techniques that are used to market unhealthy food. Exposure is known to influence children's attitudes, choices, and consumption, yet further research is required to explore the influence of contemporary techniques within online games.
OBJECTIVE


To explore the influence of modern advertising on children's attitudes, choices, and consumption, techniques (ie, banner advertising, advergame, and rewarded video advertising) were used to promote an unfamiliar confectionery brand within an online game.
DESIGN


A between-subjects randomized experimental study.
PARTICIPANTS/SETTING


Children (aged 7 to 12 years [n=156]) were recruited in New South Wales, Australia, between September and November 2017.
INTERVENTION


Children were required to play a 4-minute online game, complete some questionnaires, and choose one snack to consume afterward. Children were randomly assigned to one of four conditions: a control group with no advertising, and three experimental conditions that promoted an unfamiliar confectionery brand via a banner advertisement, advergame, or rewarded video advertisement.
MAIN OUTCOME MEASURES


Questionnaires included the assessment of attitudes to the test brand before and after the game, enjoyment of the game, and children's awareness of advertising. Food choice was recorded and food consumption was measured by weighing the snack in grams, which was translated into kilocalories.
STATISTICAL ANALYSES PERFORMED


Statistical tests included analyses of variance, Kruskal-Wallis test, and χ 2  test.
RESULTS


Attitudes toward the perception of fun (P=0.06) and taste (P=0.21) of the test brand were not influenced by condition. Children who were exposed to the rewarded video advertising chose the test brand significantly more than children in the other three conditions (P<0.002). Condition did not influence overall energy intake measured in grams (P=0.78) or kilocalories (P=0.46).
CONCLUSIONS


Children's choice of the test brand was significantly influenced by the rewarded video advertising condition (compared with control, banner advertising, and advergame conditions). This technique is prevalent across online and application games that children play yet the effects of using rewarded video advertising to promote food brands have not been explored from a public health perspective. This study contributes to the understanding of modern strategies used to market unhealthy foods to children.",2020,Children who were exposed to the rewarded video advertising chose the test brand significantly more than children in the other three conditions (P<0.002).,"[""Children's Choices of Advertised Snacks"", 'Children (aged 7 to 12 years [n=156]) were recruited in New South Wales, Australia, between September and November\xa02017']","['control group with no advertising, and three experimental conditions that promoted an unfamiliar confectionery brand via a banner advertisement, advergame, or rewarded video advertisement']","['food consumption', 'overall energy intake', ""enjoyment of the game, and children's awareness of advertising""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0006855', 'cui_str': 'Confection'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",,0.0574607,Children who were exposed to the rewarded video advertising chose the test brand significantly more than children in the other three conditions (P<0.002).,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Yeatman', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Baur', 'Affiliation': ''}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Boyland', 'Affiliation': ''}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.07.017']
1041,31845733,Comparison Between Multicomponent Exercise and Walking Interventions in Long-Term Nursing Homes: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


There is evidence that exercise interventions counteract the functional and cognitive decline experienced by long-term nursing home (LTNH) residents. To determine the most effective exercise intervention, we compared the effects of a multicomponent exercise intervention and a walking intervention on physical and cognitive performance, habitual physical activity, affective function, and quality of life among older adults living in LTNHs.
RESEARCH DESIGN AND METHODS


This 3-month single-blind randomized controlled trial (NCT03996083) involved 81 participants at 9 LTNHs randomly assigned to a multicomponent (MG) or a walking (WG) group. The MG participated in a twice-a-week individualized and progressive program composed of strength and balance exercises for 3 months. The WG was also individualized and participants walked up to 20 min per day. The primary outcome was the score on the short physical performance battery (SPPB). Secondary outcomes included other physical performance tests, habitual physical activity, cognitive performance, affective function, and quality of life.
RESULTS


Compared with the WG, the MG group showed greater improvements in physical performance, including the SPPB (p < .05). No significant differences were observed in cognitive performance or habitual physical activity. Both groups showed improvements in anxiety and quality of life (p < .05).
DISCUSSION AND IMPLICATIONS


Although both interventions were effective in maintaining or improving affective function, the MG conferred greater improvements in physical function. Therefore, multicomponent interventions would be preferable over walking-only interventions. Otherwise, individualized and progressive walking interventions should be implemented to face the rapid decline in functionality encountered in LTNHs.",2020,"Both groups showed improvements in anxiety and quality of life (p < .05).
","['older adults living in LTNHs', 'Long-Term Nursing Homes', '81 participants at 9 LTNHs randomly assigned to a']","['multicomponent (MG) or a walking (WG', 'exercise interventions', 'Multicomponent Exercise and Walking Interventions', 'multicomponent exercise intervention and a walking intervention']","['physical function', 'score on the short physical performance battery (SPPB', 'physical and cognitive performance, habitual physical activity, affective function, and quality of life', 'cognitive performance or habitual physical activity', 'effective in maintaining or improving affective function', 'physical performance tests, habitual physical activity, cognitive performance, affective function, and quality of life', 'anxiety and quality of life', 'physical performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",81.0,0.0432579,"Both groups showed improvements in anxiety and quality of life (p < .05).
","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}, {'ForeName': 'Julen', 'Initials': 'J', 'LastName': 'Gomez-Diaz', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}, {'ForeName': 'Garbiñe', 'Initials': 'G', 'LastName': 'Lozano-Real', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}, {'ForeName': 'Itxaso', 'Initials': 'I', 'LastName': 'Mugica-Errazquin', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}, {'ForeName': 'Maria Jesus', 'Initials': 'MJ', 'LastName': 'Patiño', 'Affiliation': 'DomusVi Villa Sacramento, Atarizar Kalea, 18, 20013 Donostia (Gipuzkoa), Spain.'}, {'ForeName': 'Iraia', 'Initials': 'I', 'LastName': 'Bidaurrazaga-Letona', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}, {'ForeName': 'Susana María', 'Initials': 'SM', 'LastName': 'Gil', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Leioa (Bizkaia), Spain.'}]",The Gerontologist,['10.1093/geront/gnz177']
1042,32105310,Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn's Disease: A Post Hoc Analysis From the CALM Study.,"BACKGROUND


CALM was a randomized phase 3 trial in patients with Crohn's disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points.
METHODS


The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS) <4 and no deep ulcers 48 weeks after randomization was evaluated according to CRP <5 mg/L or ≥5 mg/L and FC <250 μg/g or ≥250 μg/g. Subgroup analyses were performed according to disease location, and sensitivity analyses were conducted in patients with elevated CRP and/or FC at baseline. The association between endoscopic end points and biomarker cutoffs was performed using χ 2 test.
RESULTS


The proportion of patients who achieved the primary end point CDEIS <4 and no deep ulcers was significantly greater for those with FC <250 µg/g (74%; P < 0.001), with an additive effect for CRP <5 mg/L. The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease. Fecal calprotectin <250 µg/g, CRP <5 mg/L, and CDAI <150 gave a sensitivity/specificity of 72%/63% and positive/negative predictive values of 86%/42% for CDEIS <4 and no deep ulcers 48 weeks after randomization.
CONCLUSION


This post hoc analysis of CALM demonstrated that a cutoff of FC <250 µg/g is a useful surrogate marker for mucosal healing in CD.",2020,"The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease.","['250 μg/g or ≥250 μg', ""Crohn's Disease"", ""patients with Crohn's disease (CD""]","['CDAI', 'FC']","['Fecal calprotectin', 'inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone', 'deep ulcers', 'proportion of patients achieving CD Endoscopic Index of Severity (CDEIS']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0359961,"The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease.","[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Inflammatory Bowel Disease Unit, Department of Medicine, University of Calgary, AB, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bossuyt', 'Affiliation': 'Imelda General Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Baert', 'Affiliation': 'AZ Delta, Roeselare-Menen, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Armuzzi', 'Affiliation': 'Presidio Columbus, Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hébuterne', 'Affiliation': 'Inflammatory Bowel Disease Center, University of Nice-Sophia Antipolis, CHU of Nice, Nice, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Travis', 'Affiliation': 'Translational Gastroenterology Unit, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Department of Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': 'Global Medical Affairs, AbbVie AB, Solna, Sweden.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Kligys', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Neimark', 'Affiliation': 'Research and Development, Gastroenterology/Immunology, AbbVie Inc., Worcester, MA, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Suleiman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': 'Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa025']
1043,31746766,An Interactive Mobile Phone App (SMART 5-A-DAY) for Increasing Knowledge of and Adherence to Fruit and Vegetable Recommendations: Development and Pilot Randomized Controlled Trial.,"BACKGROUND


Fruit and vegetable consumption is important for health, but many individuals fail to consume adequate amounts for health benefits. Although many individuals are aware of current fruit and vegetable consumption recommendations, research suggests that adherence to these is hampered by low knowledge of the details of these recommendations.
OBJECTIVE


This paper reports the development and details of a pilot randomized controlled test of a novel interactive mobile phone app for addressing low knowledge of the UK 5-a-day fruit and vegetable recommendations.
METHODS


Requirements for the app were first defined by researchers and potential end users and prioritized using the MoSCoW (Must have, Should have, Could have, Won't have) method. Second, a prototype mobile phone app was developed using an agile approach. Third, the prototype app was tested in a randomized controlled pilot trial for impacts on knowledge and intake of fruit and vegetables. Volunteers were randomized to either receive (n=50) or not receive the app (n=44) for 2 or 4 weeks, and fruit and vegetable knowledge, intake, and behavior were assessed at the beginning of the study and after 1 and 2 weeks or after 2 and 4 weeks, respectively. App usage and qualitative feedback were also investigated. All findings then informed the development of a final app.
RESULTS


Low knowledge of consumption recommendations centered around portion sizes and the need for variety, and an interactive mobile phone app was considered a suitable tool for improving this knowledge in a practical manner that would be available both at time of consumption and outside of these times. The pilot test revealed improved behavior after 2 weeks compared with baseline in volunteers who received the app, but improvements in knowledge on fruit and vegetable recommendations were found in both groups, and no improvements in fruit and vegetable intakes were found in formal measures. Patterns of app usage and qualitative feedback also suggested a number of modifications. The resultant final app incorporates several behavior change techniques (goal-setting, self-monitoring, and personalized feedback) as well as aiming to improve knowledge.
CONCLUSIONS


A novel interactive mobile phone app was successfully developed based on requirements, and when tested in a pilot randomized controlled trial, this app was found to have some impacts on fruit and vegetable outcomes. Although benefits from the app were small, impacts will likely increase as a result of recent modifications. The final SMART 5-A-DAY app is available in the Google Play Store and now needs testing in the target population.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02779491; https://www.clinicaltrials.gov/ct2/show/NCT02779491.",2019,"The pilot test revealed improved behavior after 2 weeks compared with baseline in volunteers who received the app, but improvements in knowledge on fruit and vegetable recommendations were found in both groups, and no improvements in fruit and vegetable intakes were found in formal measures.",[],"['MoSCoW', 'Interactive Mobile Phone App (SMART 5-A-DAY', 'fruit and vegetables']","['fruit and vegetable intakes', 'knowledge on fruit and vegetable recommendations']",[],"[{'cui': 'C0026580', 'cui_str': 'Moscow'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",,0.0717954,"The pilot test revealed improved behavior after 2 weeks compared with baseline in volunteers who received the app, but improvements in knowledge on fruit and vegetable recommendations were found in both groups, and no improvements in fruit and vegetable intakes were found in formal measures.","[{'ForeName': 'Katherine Marie', 'Initials': 'KM', 'LastName': 'Appleton', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Passmore', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Burn', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Pidgeon', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Nation', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Boobyer', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Bournemouth University, Poole, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/14380']
1044,31842133,Effects of Whole-Body Vibration Training and Blood Flow Restriction on Muscle Adaptations in Women: A Randomized Controlled Trial.,"Centner, C, Ritzmann, R, Gollhofer, A, and König, D. Effects of whole-body vibration training and blood flow restriction on muscle adaptations in women: a randomized controlled trial. J Strength Cond Res 34(3): 603-608, 2020-The purpose of the present randomized controlled trial was to investigate potential synergistic effects of whole-body vibration (WBV) training combined with blood flow restriction (BFR) on muscle mass and strength, and jump performance. Fifty healthy women (26.1 ± 4.6 years) were randomly allocated to one of the following experimental groups: WBV training combined with BFR (WBV + BFR) or WBV only. Before and after the 10-week training intervention, muscle cross-sectional area (CSA) of the vastus lateralis (VL) and gastrocnemius medialis (GM) was evaluated. Additionally, changes in muscle strength and jump performance were assessed before and after the intervention. The level of significance was set to p < 0.05. Vastus lateralis muscle CSA increased in both groups (p < 0.05). The increase in CSA was less pronounced after WBV than WBV + BFR, although the difference was not significant (p = 0.30). Likewise, GM CSA demonstrated comparable increases in both groups with a significant main effect of time (p < 0.05) but no interaction effect (p = 0.89). Assessment of muscular strength (p = 0.70) and jump performance (p = 0.40) did not reveal significant differences between the groups. The results of the present study indicate that the combination of WBV training with BFR shows a noticeable trend toward higher increases in muscle CSA compared with WBV alone. Despite the lack of significance, the results imply clinical relevance particularly in populations showing contraindications toward high training loads. This, however, needs to be confirmed in future research.",2020,Assessment of muscular strength (p = 0.70) and jump performance (p = 0.40) did not reveal significant differences between the groups.,"['Women', 'women', 'Fifty healthy women (26.1 ± 4.6 years']","['WBV training combined with BFR (WBV + BFR) or WBV only', 'J Strength Cond Res XX(X', 'Whole-Body Vibration Training and Blood Flow Restriction', 'whole-body vibration (WBV) training combined with blood flow restriction (BFR']","['muscular strength', 'Vastus lateralis muscle CSA', 'muscle strength and jump performance', 'jump performance', 'muscle mass and strength, and jump performance', 'muscle CSA', 'CSA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0224444', 'cui_str': 'Vastus Lateralis'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",50.0,0.0260128,Assessment of muscular strength (p = 0.70) and jump performance (p = 0.40) did not reveal significant differences between the groups.,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Centner', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Ritzmann', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Freiburg im Breisgau, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003401']
1045,32435878,Remote Peer Learning Between US and Cambodian Lay Health Workers to Improve Outcomes for Cambodians with Type 2 Diabetes: a Pilot Study.,"BACKGROUND


This paper reports a single-group, pre-post pilot of a peer-learning intervention between community health workers (CHWs) in the USA and Village Health Support Guides (Guides) in Cambodia to improve outcomes for Cambodians with type 2 diabetes (T2D).
METHOD


Two US-based CHWs were trained in a culturally derived cardiometabolic education curriculum called Eat, Walk, Sleep (EWS) and they were also trained in principles of peer learning. They in turn trained five Cambodia-based Guides remotely through videoconference with a phablet in EWS. Finally, Cambodia-based Guides met with 58 patients with diabetes, face-to-face in their villages, monthly for 6 months to deliver EWS. US-based CHWs and Cambodia-based Guides responded to surveys at baseline and post-treatment. Patients responded to surveys and provided blood pressure and blood samples at baseline and post-treatment.
RESULTS


For US-based CHWs, scores on all surveys of diabetes knowledge, self-evaluation, job satisfaction, and information technology improved, though no statistical tests were run due to sample size. For Cambodia-based Guides, all scores on these same measures improved except for job satisfaction. For patients, n = 60 consented, 2 withdrew, and 7 were lost to follow-up leaving n = 51 for analysis. In paired t tests, patients showed significantly decreased A1c, decreased systolic and diastolic blood pressures, improved attitudes toward medicines, and a trend for switching from all-white to part-brown rice. No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
CONCLUSION


If proven effective in a controlled trial, cross-country peer learning could eventually help other diaspora communities.",2020,"No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
","['Cambodian Lay Health Workers', 'Cambodians with Type 2 Diabetes', '58 patients with diabetes', 'Cambodians with type 2 diabetes (T2D']","['peer-learning intervention', 'culturally derived cardiometabolic education curriculum called Eat, Walk, Sleep (EWS) and they were also trained in principles of peer learning']","['systolic and diastolic blood pressures, improved attitudes toward medicines', 'self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed', 'diabetes knowledge, self-evaluation, job satisfaction, and information technology', 'blood pressure and blood samples']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0021423', 'cui_str': 'Information Sciences'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0231657,"No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'University of Connecticut Schools of Dental Medicine and Medicine, 263 Farmington Ave., MC3910, Farmington, CT, 06030, USA. juwagner@uchc.edu.'}, {'ForeName': 'S Megan', 'Initials': 'SM', 'LastName': 'Berthold', 'Affiliation': 'University of Connecticut School of Social Work, Hartford, CT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Buckley', 'Affiliation': 'University of Connecticut School of Pharmacy, Storrs, CT, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bermudez-Millan', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Ha', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Theanvy', 'Initials': 'T', 'LastName': 'Kuoch', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Sengly', 'Initials': 'S', 'LastName': 'Kong', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Fraser-King', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}, {'ForeName': 'Ien Srey', 'Initials': 'IS', 'LastName': 'Horn', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}, {'ForeName': 'Lim', 'Initials': 'L', 'LastName': 'Keuky', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09896-3']
1046,31509451,Secondary Outcomes from a Randomized Controlled Trial of Yoga for Veterans with Chronic Low-Back Pain.,"Chronic low-back pain (cLBP) is a prevalent condition, and rates are higher among military veterans. cLBP is a persistent condition, and treatment options have either modest effects or a significant risk of side-effects, which has led to recent efforts to explore mind-body intervention options and reduce opioid medication use. Prior studies of yoga for cLBP in community samples, and the main results of a recent trial with military veterans, indicate that yoga can reduce back-related disability and pain intensity. Secondary outcomes from the trial of yoga with military veterans are presented here. In the study, 150 military veterans (Veterans Administration patients) with cLBP were randomized to either yoga or a delayed-treatment group receiving usual care between 2013 and 2015. Assessments occurred at baseline, 6 weeks, 12 weeks, and 6 months. Intent-to-treat analyses were conducted. Yoga classes lasting 60 minutes each were offered twice weekly for 12 weeks. Yoga sessions consisted of physical postures, movement, focused attention, and breathing techniques. Home practice guided by a manual was strongly recommended. The primary outcome measure was Roland-Morris Disability Questionnaire scores after 12 weeks. Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage. Yoga participants improved more than delayed-treatment participants on pain interference, fatigue, quality of life, and self-efficacy at 12 weeks and/or 6 months. Yoga participants had greater improvements across a number of important secondary health outcomes compared to controls. Benefits emerged despite some veterans facing challenges with attending yoga sessions in person. The findings support wider implementation of yoga programs for veterans, with attention to increasing accessibility of yoga programs in this population.",2019,"Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage.","['military veterans', 'Veterans with Chronic Low-Back Pain', '150 military veterans (Veterans Administration patients) with cLBP']","['cLBP', 'yoga or a delayed-treatment group receiving usual care', 'physical postures, movement, focused attention, and breathing techniques']","['Chronic low-back pain (cLBP', 'pain interference, fatigue, quality of life, and self-efficacy', 'Roland-Morris Disability Questionnaire scores', 'number of important secondary health outcomes', 'pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0589098', 'cui_str': 'Focused attention, function (observable entity)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",150.0,0.075649,"Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage.","[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': '1. VA San Diego Healthcare System; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': '1. VA San Diego Healthcare System; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmalzl', 'Affiliation': '2. College of Science and Integrative Health, Southern California University of Health Sciences, Whittier; and Department of Family Medicine and Public Health, University of California San Diego.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'Chang', 'Affiliation': '3. VA San Diego Healthcare System; and Department of Orthopedic Surgery, University of California San Diego.'}, {'ForeName': 'Adhana', 'Initials': 'A', 'LastName': 'McCarthy', 'Affiliation': '4. SDSU/UC San Diego Joint Doctoral Program in Public Health, La Jolla, Calif.; and Army Medical Department Center and Schools, San Antonio.'}, {'ForeName': 'Won I', 'Initials': 'WI', 'LastName': 'Chun', 'Affiliation': '5. VA San Diego Healthcare System; and Department of Orthopedic Surgery, University of California San Diego.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Sinclair', 'Affiliation': '6. VA San Diego Healthcare System.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Bormann', 'Affiliation': '7. Hahn School of Nursing & Health Sciences, University of San Diego; and VA Center of Excellence in Stress and Mental Health, San Diego.'}]",International journal of yoga therapy,['10.17761/2020-D-19-00036']
1047,31501084,Regression Discontinuity Analysis of Salvage Radiotherapy in Prostate Cancer.,"There is a lack of randomized evidence comparing early (eSRT) to late (lSRT) salvage radiotherapy (SRT) after radical prostatectomy (RP) for prostate cancer (PCa). Moreover, the existing evidence is often affected by lead-time bias. We sought to address this gap in a cohort of 1458 PCa patients undergoing SRT for biochemical recurrence (BCR) after RP in two tertiary care centers between 1992 and 2013. Using a quasi-randomized study design known as regression discontinuity (RD) and adjusting for lead-time bias, we compared metastasis-free survival (MFS) at 5 and 10 years after surgery between eSRT (prostate-specific antigen [PSA] <0.5 ng/ml) and lSRT (PSA ≥ 0.5 ng/ml). Overall, 1049 patients (71.9%) underwent eSRT and 409 (28.1%) lSRT at a mean follow-up of 84 mo (interquartile range (IQR) 52-120.4). The MFS rate decreased nonsignificantly at the proposed cutoff by 0.04 (95% confidence interval [CI]: -0.06 to 0.19) at 5 years and by 0.07 (95% CI: - 0.12 to 0.32) at 10 years. Cox regression analysis revealed a hazard ratio for the cutoff examined of 1.3 (95% CI: 0.8-2.4; p = 0.2). In conclusion, in a quasirandomized study design accounting for lead-time bias, eSRT (PSA < 0.5 ng/ml) did not improve MFS. Our results underline the need for level-one evidence to compare eSRT and lSRT. PATIENT SUMMARY: We compared early versus late salvage radiotherapy (SRT) for biochemical recurrence after radical prostatectomy by simulating a randomized trial. We found that early SRT (initiated at prostate-specific antigen <0.5 ng/ml) compared to late SRT did not improve metastasis-free survival.",2019,The MFS rate decreased nonsignificantly at the proposed cutoff by 0.04,"['1458 PCa patients undergoing SRT for biochemical recurrence (BCR) after RP in two tertiary care centers between 1992 and 2013', 'Prostate Cancer']","['eSRT', 'late salvage radiotherapy (SRT', 'early (eSRT) to late (lSRT) salvage radiotherapy (SRT) after radical prostatectomy (RP']","['MFS', 'MFS rate', 'metastasis-free survival']","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1049.0,0.228079,The MFS rate decreased nonsignificantly at the proposed cutoff by 0.04,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Gild', 'Affiliation': 'Center for Outcomes Research, Analytics and Evaluation, Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA; Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Raisa S', 'Initials': 'RS', 'LastName': 'Pompe', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Martini-Klinik Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seisen', 'Affiliation': 'Department of Urology, Hôpital Pitié-Salpetrière, Sorbonne Université, Paris, France.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Keeley', 'Affiliation': 'Center for Outcomes Research, Analytics and Evaluation, Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Hoang J', 'Initials': 'HJ', 'LastName': 'Tang', 'Affiliation': 'Center for Outcomes Research, Analytics and Evaluation, Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bossi', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Institute, Villejuif, France.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Tilki', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Martini-Klinik Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Mani', 'Initials': 'M', 'LastName': 'Menon', 'Affiliation': 'Center for Outcomes Research, Analytics and Evaluation, Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Abdollah', 'Affiliation': 'Center for Outcomes Research, Analytics and Evaluation, Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA. Electronic address: fabdoll1@hfhs.org.'}]",European urology oncology,['10.1016/j.euo.2019.08.005']
1048,15733070,High-dose glucose-insulin-potassium treatment reduces myocardial apoptosis in patients with acute myocardial infarction.,"BACKGROUND


Several clinical trials have suggested that a metabolic cocktail of glucose-insulin-potassium (GIK) decreases mortality rates in patients with acute myocardial infarction (AMI). It has also been reported that Fas-mediated apoptosis plays an important role in ischaemic/reperfusion injury in the rat model. This study was designed to evaluate the interaction of ischaemic/reperfusion and reperfusion therapy coadministered with high-dose GIK treatment on soluble Fas/APO-1 (sFas) and Fas ligand (sFasL) plasma concentration in patients with AMI.
MATERIALS AND METHODS


Seventy-four patients presenting with AMI who underwent reperfusion therapy were randomized into a GIK group (n = 35) receiving high-dose GIK for 24 h or a vehicle group (n = 39). Thirty-four control subjects were also enrolled in the present study. Strepavidin-biotin ELISA was used to determine the soluble sFas and sFasL plasma concentration at baseline, 24 h (h), 3 day (d), 7 d and 14 d.
RESULTS


Soluble Fas and sFas-L serum concentrations ([sFas] and [sFas-L]) of patients with AMI were significantly elevated at baseline as compared with normal controls (NCs; P < 0.01 vs. NC). The sFas in the GIK and vehicle groups markedly decreased 24 h after the GIK infusion (10.7-->5.9 ng mL(-1) and 9.7-->6.5 ng mL(-1); P < 0.01 vs. baseline) and then increased during the 3-7-d period (5.9-->12.1 ng mL(-1) and 6.5-->11.1 ng mL(-1); P < 0.01 vs. 24 h). The GIK group demonstrated reduced sFas (12.1-->5.9 ng mL(-1)) at 14 d (P < 0.01 vs. 7 d), with no concomitant changes in the vehicle group. The sFas-L in the GIK and vehicle groups was not significant different during the 14-d period.
CONCLUSIONS


These results indicate that the sFas and sFasL in patients with AMI increased significantly compared with NC. Owing to the cardioprotective effects reported here and by others, a high-dose GIK infusion co-administered with the timely re-establishment of nutritive perfusion should be strongly considered as a treatment of choice for AMI. Additionally, sFas may be a valuable marker of the physiological response to ischaemic/reperfusion injury and reperfusion associated with high-dose GIK treatment.",2005,"The GIK group demonstrated reduced sFas (12.1-->5.9 ng mL(-1)) at 14 d (P < 0.01 vs. 7 d), with no concomitant changes in the vehicle group.","['patients with acute myocardial infarction (AMI', 'Seventy-four patients presenting with AMI who underwent', 'Thirty-four control subjects', 'patients with acute myocardial infarction', 'patients with AMI']","['Strepavidin-biotin ELISA', 'GIK group (n = 35) receiving high-dose GIK', 'High-dose glucose-insulin-potassium treatment', 'glucose-insulin-potassium (GIK', 'reperfusion therapy']","['soluble Fas/APO-1 (sFas) and Fas ligand (sFasL) plasma concentration', 'sFas-L', 'mortality rates', 'Soluble Fas and sFas-L serum concentrations ([sFas] and [sFas-L]) of patients with AMI', 'reduced sFas', 'myocardial apoptosis', 'soluble sFas and sFasL plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0075278', 'cui_str': 'Strepavidin'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0253023', 'cui_str': 'Fas Ligand'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}]",74.0,0.0432611,"The GIK group demonstrated reduced sFas (12.1-->5.9 ng mL(-1)) at 14 d (P < 0.01 vs. 7 d), with no concomitant changes in the vehicle group.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Heart Center, Institute of Cardiovascular Disease, Capital Medical University Chaoyang Hospital, 8 Baijiazhuang Road, 100-020 Beijing, China. linzhangpeking@hotmail.com'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'M-M', 'Initials': 'MM', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Yang', 'Affiliation': ''}]",European journal of clinical investigation,[]
1049,31506369,Sources of Error in Office Blood Pressure Measurement.,"PURPOSES


To evaluate 2 commonly overlooked sources of error in measuring blood pressure (BP) in the office, improper patient positioning and frequency of terminal digit bias (TDB) using manual and automated (BP) devices.
METHODS


BPs recorded by 3 nurses using manual and automated devices were analyzed for TDB. In the next part of the study, 294 patients were recruited and tested with each patient's BP measured twice in the table position and compared with BP measured in the chair position. To eliminate concern for position sequence, a randomized controlled trial was initially conducted.
RESULTS


Significant TDB for the digit zero was identified in BPs measured by all nurses using a manual device. No such bias was identified for any nurse when measuring BP with an automated device. For the positional study, the randomized controlled study showed no significant sequencing effect therefore the sequence of table then chair BP measurements was adopted. Significant BP lowering was observed in 128 patients (42.7%) in the chair compared with the table position. Misclassification of prehypertension and hypertension would have occurred in 15.3% and 16% of patients, respectively, when BP was recorded in the table instead of the chair position.
CONCLUSIONS


Significant TDB was identified for all nurses when using a manual but not an automated device. Patient positioning on the examination table resulted in elevations of systolic and diastolic BPs.",2019,Significant BP lowering was observed in 128 patients (42.7%) in the chair compared with the table position.,['294 patients'],[],"['Misclassification of prehypertension and hypertension', 'Significant BP lowering', 'blood pressure (BP', 'elevations of systolic and diastolic BPs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",294.0,0.0684168,Significant BP lowering was observed in 128 patients (42.7%) in the chair compared with the table position.,"[{'ForeName': 'Roy N', 'Initials': 'RN', 'LastName': 'Morcos', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC). Roy_Morcos@mercy.com.'}, {'ForeName': 'Kimbroe J', 'Initials': 'KJ', 'LastName': 'Carter', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Castro', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Sumira', 'Initials': 'S', 'LastName': 'Koirala', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}, {'ForeName': 'Haroon', 'Initials': 'H', 'LastName': 'Syed', 'Affiliation': 'From the Department of Family and Community Medicine, Northeast Ohio Medical University, Rootstown, OH (RNM, SK); Department of Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (RNM); Medical Decision Making Society of Youngstown Ohio, c/o Jeghers Medical Index, St. Elizabeth Youngstown Hospital, Youngstown, OH (FC, KJC); Family Medicine Residency Program, St. Elizabeth Boardman, Mercy Health (SK, DS); Department of Pathology, Northeast Ohio Medical University, Rootstown, OH (KJC).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.05.190085']
1050,31506877,Effects of lung protective ventilation on postoperative respiratory parameters in patients undergoing robot-assisted radical prostatectomy.,"To investigate the effects of lung protective ventilation (LPV) compared to conventional ventilation (CV) on postoperative respiratory parameters in patients undergoing robot-assisted radical prostatectomy (RARP). In total, 24 patients undergoing RARP were randomized to two groups receiving either LPV with a tidal volume of 6 ml/IBW with a positive end-expiratory pressure (PEEP) of 10 cm H 2 O (intervention) or CV with a tidal volume of 10 ml/IBW with a PEEP of 4 cmH 2 O (control). Primary endpoint was PaO 2  2 h postoperatively after 10 min of spontaneous respiration of atmospheric air. Forced expiratory volume during the first second (FEV 1 ), forced vital capacity (FVC), diffusion capacity (DLCO), and plasma interleukin-6 (IL-6) was measured before and after the surgery. Pulmonary complications were registered within the first year after surgery. All patients completed the study. No difference was found in PaO 2  between LPV and CV. However, 4 patients in the LPV group had a decrease in saturation below 90% during the 10 min of spontaneous respiration of atmospheric air compared to none in the CV group. FEV 1 , FVC, and DLCO were similar when comparing the two groups at all timepoints and no patients in either of the groups had pulmonary complications during the first postoperative year. IL-6 levels increased during surgery in both groups, but were not significantly different between the two groups. We found no evidence of lung protective effects of LPV compared to CV estimated by pulmonary function tests, IL-6 levels and postoperative complications in patients undergoing RARP. Surprisingly, only patients in the LPV group and none in the CV group had a decline in saturation below 90% during the 10 min of breathing atmospheric air.",2020,"We found no evidence of lung protective effects of LPV compared to CV estimated by pulmonary function tests, IL-6 levels and postoperative complications in patients undergoing RARP.","['patients undergoing robot-assisted radical prostatectomy', 'patients undergoing RARP', '24 patients undergoing RARP', 'patients undergoing robot-assisted radical prostatectomy (RARP']","['conventional ventilation (CV', 'LPV with a tidal volume of 6\xa0ml/IBW with a positive end-expiratory pressure (PEEP) of 10\xa0cm H 2 O (intervention) or CV with a tidal volume of 10\xa0ml/IBW with a PEEP of 4 cmH 2 O (control', 'LPV', 'lung protective ventilation', 'lung protective ventilation (LPV']","['pulmonary complications', 'FEV 1 , FVC, and DLCO', 'PaO 2  2\xa0h postoperatively after 10\xa0min of spontaneous respiration of atmospheric air', 'Forced expiratory volume during the first second (FEV 1 ), forced vital capacity (FVC), diffusion capacity (DLCO), and plasma interleukin-6 (IL-6', 'pulmonary function tests, IL-6 levels and postoperative complications', 'saturation', 'IL-6 levels', 'postoperative respiratory parameters', 'Pulmonary complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0554066,"We found no evidence of lung protective effects of LPV compared to CV estimated by pulmonary function tests, IL-6 levels and postoperative complications in patients undergoing RARP.","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Mølsted', 'Affiliation': 'Department of Urology, Regional Hospital of West Jutland, Holstebro, Denmark. mette_molsted@hotmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ekeløf', 'Affiliation': 'Department of Anaestesiology, Regional Hospital of West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Jesper Nørgaard', 'Initials': 'JN', 'LastName': 'Bech', 'Affiliation': 'University Clinic in Nephrology and Hypertension, Regional Hospital of West Jutland, Aarhus University, Holstebro, Denmark.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Wessels', 'Affiliation': 'Department of Pulmonary Medicine, Regional Hospital of West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Jørgen Bjerggaard', 'Initials': 'JB', 'LastName': 'Jensen', 'Affiliation': 'Department of Urology, Regional Hospital of West Jutland, Holstebro, Denmark.'}]",Journal of robotic surgery,['10.1007/s11701-019-01016-y']
1051,32437025,Pharmacokinetics and Safety of Ranirestat in Patients With Hepatic Impairment.,"Ranirestat is an aldose reductase inhibitor hypothesized to improve diabetic neuropathy. An open-label, single-dose, parallel-group study was conducted to compare pharmacokinetic (PK) characteristics of an oral dose of ranirestat across subjects with normal hepatic function and patients with mild and moderate hepatic impairment because ranirestat is expected to be used by patients with diabetes mellitus, possibly including those with hepatic impairment. To evaluate the necessity for dose adjustment, PK profiles and tolerability were studied at the dose of 40 mg, the expected optimal clinical dose in patients with diabetic neuropathy and normal hepatic function. In total, 20 subjects, including 5, 10, and 5 subjects with normal hepatic function, mild hepatic impairment, and moderate hepatic impairment, respectively, completed the study. Serial PK sampling was conducted up to 504 hours, and PK parameters were calculated and compared between healthy subjects and patients with mild or moderate hepatic impairment. The geometric mean ratios of peak concentration and area under the concentration-time curve in patients with mild hepatic impairment (90%CI) were 86.7% (55.3% to 135.9%) and 84.7% (68.5% to 104.8%), respectively. The values in patients with moderate hepatic impairment were 81.3% (48.8% to 135.5%) and 91.7% (72.1% to 116.7%), respectively. These results demonstrated that plasma ranirestat exposure and the plasma protein binding of the drug were not substantially altered by normal, mild, or moderate hepatic impairment (protein binding 99.22%, 99.29%, and 99.00%, respectively). All adverse events were mild in severity. Based on these findings, no dose adjustment will be required for ranirestat in patients with mild or moderate hepatic impairment.",2020,All adverse events were mild in severity.,"['In total, 20 subjects, including 5, 10, and 5 subjects with normal hepatic function, mild hepatic impairment, and moderate hepatic impairment, respectively, completed the study', 'healthy subjects and patients with mild or moderate hepatic impairment', 'patients with mild or moderate hepatic impairment', 'patients with diabetes mellitus, possibly including those with hepatic impairment', 'across subjects with normal hepatic function and patients with mild and moderate hepatic impairment because ranirestat', 'patients with diabetic neuropathy and normal hepatic function', 'Patients With Hepatic Impairment']",['ranirestat'],"['moderate hepatic impairment', 'plasma ranirestat exposure and the plasma protein binding', 'geometric mean ratios of peak concentration and area under the concentration-time curve']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}, {'cui': 'C3266874', 'cui_str': 'ranirestat'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}]","[{'cui': 'C3266874', 'cui_str': 'ranirestat'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3266874', 'cui_str': 'ranirestat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",20.0,0.0316012,All adverse events were mild in severity.,"[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Itou', 'Affiliation': 'JSDF Hanshin Hospital, Hyogo, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Pharmacology and Toxicology, Dokkyo Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Division of Gastroenterology, Showa University Fujigaoka Hospital, Kanagawa, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Takagaki', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ishii', 'Affiliation': 'Group I, Oncology Clinical Development Unit, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kakuyama', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}]",Journal of clinical pharmacology,['10.1002/jcph.1636']
1052,32433273,β-Galactooligosaccharide in Conjunction With Low FODMAP Diet Improves Irritable Bowel Syndrome Symptoms but Reduces Fecal Bifidobacteria.,"INTRODUCTION


The low FODMAP diet (LFD) reduces symptoms and bifidobacteria in irritable bowel syndrome (IBS). β-galactooligosaccharides (B-GOS) may reduce the symptoms and increase bifidobacteria in IBS. We investigated whether B-GOS supplementation alongside the LFD improves IBS symptoms while preventing the decline in bifidobacteria.
METHODS


We performed a randomized, placebo-controlled, 3-arm trial of 69 Rome III adult patients with IBS from secondary care in the United Kingdom. Patients were randomized to a sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD) or 1.4 g/d B-GOS (LFD/B-GOS) for 4 weeks. Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR) were analyzed.
RESULTS


At 4 weeks, adequate symptom relief was higher in the LFD/B-GOS group (16/24, 67%) than in the control group (7/23, 30%) (odds ratio 4.6, 95% confidence interval: 1.3-15.6; P = 0.015); Bifidobacterium concentrations (log10 cells/g dry weight) were not different between LFD and LFD/B-GOS but were lower in the LFD/B-GOS (9.49 [0.73]) than in the control (9.77 [0.41], P = 0.018). A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%). Fecal butyrate was lower in the LFD (387.3, P = 0.028) and LFD/B-GOS (346.0, P = 0.007) groups than in the control group (609.2).
DISCUSSION


The LFD combined with B-GOS prebiotic produced a greater symptom response than the sham diet plus placebo, but addition of 1.4 g/d B-GOS did not prevent the reduction of bifidobacteria. The LFD reduces fecal Actinobacteria and butyrate thus strict long-term use should not be advised.",2020,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","['69 Rome III adult patients with IBS from secondary care in the United Kingdom', 'irritable bowel syndrome (IBS']","['β-Galactooligosaccharide', 'β-galactooligosaccharides (B-GOS', 'sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD', 'Low FODMAP Diet', 'low FODMAP diet (LFD', 'LFD combined with B-GOS prebiotic', 'placebo']","['Bifidobacterium concentrations', 'Fecal butyrate', 'LFD/B-GOS', 'IBS symptoms', 'adequate symptom relief', 'Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR', 'reduction of bifidobacteria', 'symptom response']","[{'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0162789', 'cui_str': 'Fluorescence in situ hybridization'}, {'cui': 'C0035702', 'cui_str': '16S Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0008556', 'cui_str': 'Gas liquid chromatography measurement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0915586,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","[{'ForeName': 'Bridgette', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tokuwa', 'Initials': 'T', 'LastName': 'Kanno', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Gareth C', 'Initials': 'GC', 'LastName': 'Parkes', 'Affiliation': 'Department of Gastroenterology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Lomer', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000641']
1053,31994703,"Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes.","AIMS


To study the pharmacodynamics and pharmacokinetics of selatogrel, a novel P2Y12 receptor antagonist for subcutaneous administration, in patients with chronic coronary syndromes (CCS).
METHODS AND RESULTS


In this double-blind, randomized study of 345 patients with CCS on background oral antiplatelet therapy, subcutaneous selatogrel (8 mg, n = 114; or 16 mg, n = 115) was compared with placebo (n = 116) (ClinicalTrials.gov: NCT03384966). Platelet aggregation was assessed over 24 h (VerifyNow assay) and 8 h (light transmittance aggregometry; LTA). Pharmacodynamic responders were defined as patients having P2Y12 reaction units (PRU) <100 at 30 min post-dose and lasting ≥3 h. At 30 min post-dose, 89% of patients were responders to selatogrel 8 mg, 90% to selatogrel 16 mg, and 16% to placebo (P < 0.0001). PRU values (mean ± standard deviation) were 10 ± 25 (8 mg), 4 ± 10 (16 mg), and 163 ± 73 (placebo) at 15 min and remained <100 up to 8 h for both doses, returning to pre-dose or near pre-dose levels by 24 h post-dose. LTA data showed similarly rapid and potent inhibition of platelet aggregation. Selatogrel plasma concentrations peaked ∼30 min post-dose. Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%).
CONCLUSIONS


Selatogrel was rapidly absorbed following subcutaneous administration in CCS patients, providing prompt, potent, and consistent platelet P2Y12 inhibition sustained for ≥8 h and reversible within 24 h. Further studies of subcutaneous selatogrel are warranted in clinical scenarios where rapid platelet inhibition is desirable.",2020,"Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%).
","['patients with chronic coronary syndromes', '345 patients with', 'patients with chronic coronary syndromes (CCS']","['placebo', 'CCS on background oral antiplatelet therapy, subcutaneous selatogrel']","['safe and well-tolerated with transient dyspnoea occurring overall', 'PRU values', 'Selatogrel plasma concentrations', 'Platelet aggregation', 'Pharmacodynamics, pharmacokinetics, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",345.0,0.368598,"Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%).
","[{'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Jurrien', 'Initials': 'J', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiologie, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Bernaud', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'Division of Cardiology, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Frenoux', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'University of Hertfordshire, Hertfordshire, UK.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Hmissi', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kunadian', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Department of Medicine, Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Tran', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Van der Harst', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Arnoud W J', 'Initials': 'AWJ', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre (MUMC), Maastricht, Netherlands.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.'}]",European heart journal,['10.1093/eurheartj/ehz807']
1054,32433277,Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery.,"BACKGROUND


Prospective trials of enhanced recovery after spine surgery are lacking. We tested the hypothesis that an enhanced recovery pathway improves quality of recovery after one- to two-level lumbar fusion.
METHODS


A patient- and assessor-blinded trial of 56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed. The primary outcome was Quality of Recovery-40 score (40 to 200 points) at postoperative day 3. Twelve points defined the clinically important difference. Secondary outcomes included Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein).
RESULTS


The analysis included 25 enhanced recovery patients and 26 usual care patients. Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference. There were no significant differences in recovery scores at days 0 (175 ± 16 vs. 162 ± 22; P = 0.059), 1 (174 ± 18 vs. 164 ± 15; P = 0.050), 2 (174 ± 18 vs. 167 ± 17; P = 0.289), 14 (184 ± 13 vs. 180 ± 12; P = 0.500), and 56 (187 ± 14 vs. 190 ± 8; P = 0.801). In the enhanced recovery group, subscores on the Quality of Recovery-40 comfort dimension were higher (longitudinal mean score difference, 4; 95% CI, 1, 7; P = 0.008); time to oral intake (-3 h; 95% CI, -6, -0.5; P = 0.010); and duration of intravenous patient-controlled analgesia (-11 h; 95% CI, -19, -6; P < 0.001) were shorter; opioid consumption was lower at day 1 (-57 mg; 95% CI, -130, -5; P = 0.030) without adversely affecting pain scores (-2; 95% CI, -3, 0; P = 0.005); and C-reactive protein was lower at day 3 (6.1; 95% CI, 3.8, 15.7 vs. 15.9; 95% CI, 6.6, 19.7; P = 0.037).
CONCLUSIONS


Statistically significant gains in early recovery were achieved by an enhanced recovery pathway. However, significant clinical impact was not demonstrated.",2020,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"['56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed', '25 enhanced recovery patients and 26 usual care patients', 'patients undergoing one- or two-level lumbar spinal fusion', 'Lumbar Spine Fusion']",[],"['pain scores', 'time to oral intake', 'shorter; opioid consumption', 'Quality of Recovery-40 comfort dimension', 'Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein', 'quality of recovery', 'duration of intravenous patient-controlled analgesia', 'time to oral intake, duration of patient-controlled analgesia use, and day 1 opioid consumption', 'Quality of Recovery-40 score', 'Quality of Patient Recovery', 'recovery scores', 'C-reactive protein', 'Quality of Recovery-40 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}]",[],"[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",56.0,0.363217,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Soffin', 'Affiliation': 'From the Departments of Anesthesiology, Critical Care and Pain Management, (E.M.S., J.D.B., A.T., M.U., C.R.G., J.A.N., I.F.A., S.G.M.) Orthopedic Surgery (R.C.H., H.-J.K., F.P.C., F.J.S.) the Biostatistics Core (H.Z.), Hospital for Special Surgery, New York, New York; and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Beckman', 'Affiliation': ''}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tseng', 'Affiliation': ''}, {'ForeName': 'Haoyan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Russel C', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Urban', 'Affiliation': ''}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Guheen', 'Affiliation': ''}, {'ForeName': 'Han-Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Cammisa', 'Affiliation': ''}, {'ForeName': 'Jemiel A', 'Initials': 'JA', 'LastName': 'Nejim', 'Affiliation': ''}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Schwab', 'Affiliation': ''}, {'ForeName': 'Isabel F', 'Initials': 'IF', 'LastName': 'Armendi', 'Affiliation': ''}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Memtsoudis', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003346']
1055,31800067,Association of β-Blocker Use With Heart Failure Hospitalizations and Cardiovascular Disease Mortality Among Patients With Heart Failure With a Preserved Ejection Fraction: A Secondary Analysis of the TOPCAT Trial.,"Importance


β-Blockers are prescribed to most patients with heart failure (HF) with a preserved ejection fraction (HFpEF), but their effect on HFpEF remains unclear.
Objective


To determine the association of β-blocker use with HF hospitalizations and cardiovascular disease (CVD) mortality, overall and in strata of patients with an ejection fraction (EF) of 50% or greater or less than 50%.
Design, Setting, and Participants


For 1761 participants from North and South America enrolled in the multicenter, double-blinded Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist randomized clinical trial of spironolactone for patients with HFpEF between August 10, 2006, and January 31, 2012, the association of baseline β-blocker use with HF hospitalization and CVD mortality was analyzed using unadjusted and adjusted Cox proportional hazards regression models, overall and in strata of patients with an EF of 50% or greater or less than 50%. Participants had symptomatic HF with a left ventricular EF of 45% or greater, with enrollment based on either hospitalization attributed to decompensated HF in the prior year or elevated natriuretic peptide levels. Statistical analysis was performed from January 31 to May 2, 2019.
Exposure


Use of β-blockers.
Main Outcomes and Measures


Incident HF hospitalization and CVD mortality.
Results


Among 1761 participants included in the analysis (879 women and 882 men; mean [SD] age, 71.5 [9.6] years), 1394 (79.2%) reported β-blocker use and 1567 (89.0%) had an EF of 50% or greater. Hospitalizations for HF occurred for 399 participants (22.7%), and CVD mortality occurred for 229 participants (13.0%). Use of β-blockers was associated with a higher risk of HF hospitalization among patients with HFpEF with an EF of 50% or greater (hazard ratio, 1.74 [95% CI, 1.28-2.37]; P < .001) but not among patients with an EF between 45% and 49% (hazard ratio, 0.68 [95% CI, 0.28-1.63]; P = .39). There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03). Use of β-blockers was not associated with a change in CVD mortality.
Conclusions and Relevance


For patients with an EF of 50% or greater, β-blocker use was associated with an increased risk of HF hospitalizations but not CVD mortality. For patients with an EF between 45% and 49%, there was no such association.",2019,There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03).,"['patients with an ejection fraction (EF) of 50% or greater or less than 50', 'Patients With Heart Failure', '1761 participants included in the analysis (879 women and 882 men; mean [SD] age, 71.5 [9.6] years), 1394 (79.2%) reported β-blocker use and 1567 (89.0%) had an EF of 50% or greater', 'Participants had symptomatic HF with a left ventricular EF of 45% or greater, with enrollment based on either hospitalization attributed to decompensated HF in the prior year or elevated natriuretic peptide levels', 'patients with an EF of 50% or greater or less than 50', '1761 participants from North and South America enrolled in the multicenter, double-blinded Treatment of Preserved Cardiac Function Heart Failure with an', 'patients with heart failure (HF) with a preserved ejection fraction (HFpEF']","['Aldosterone Antagonist', 'Preserved Ejection Fraction', 'spironolactone']","['Cardiovascular Disease Mortality', 'HF hospitalizations and cardiovascular disease (CVD) mortality', 'Measures\n\n\nIncident HF hospitalization and CVD mortality', 'risk of HF hospitalizations', 'HF hospitalization and CVD mortality', 'higher risk of HF hospitalization', 'Hospitalizations for HF', 'CVD mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]",1761.0,0.150451,There was a significant interaction between β-blocker use and EF threshold for incident HF hospitalizations (P = .03).,"[{'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Silverman', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Infeld', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Callas', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Geoff B', 'Initials': 'GB', 'LastName': 'Dougherty', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Department of Medicine and Biostatistics Unit, Larner College of Medicine, University of Vermont, Burlington.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.16598']
1056,31613046,Upstream anticoagulation for patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: Insights from the TOTAL trial.,"OBJECTIVES


To assess the relationship between preprocedural anticoagulation use and clinical and angiographic outcomes.
BACKGROUND


For patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the optimal timing of anticoagulant administration remains uncertain.
METHODS


Patients enrolled in the TOTAL trial were stratified based on whether or not they had received any parenteral anticoagulant prior to randomization and PCI. Baseline and procedural characteristics were compared. For one-year clinical outcomes, Cox proportional modeling adjusted on a propensity score was used to analyze differences between groups. Angiographic endpoints were analyzed by logistic regression models adjusted for propensity scores.
RESULTS


In the trial, 10,064 patients were enrolled and underwent PCI. Preprocedural anticoagulation was used in 6,381 patients (63%).The most common anticoagulant was intravenous unfractionated heparin (5,188, 81%). Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI. Pretreatment with anticoagulation was associated with lower use of bailout thrombectomy, GP IIb/IIIa inhibitors, and intra-aortic balloon pump. After adjustment, preprocedural anticoagulation was associated with lower rates of CABG and minor bleeding at 1 year but there were no significant differences in death, stroke, recurrent MI, cardiogenic shock, or congestive heart failure.
CONCLUSIONS


Preprocedural anticoagulation is associated with improved flow and reduced thrombus in the IRA prior to PCI, less bailout thrombectomy during PCI but no difference in death, recurrent infarction, or heart failure at 1 year.",2020,Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI.,"['patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention', '6,381 patients (63%).The most common anticoagulant was intravenous', 'Patients enrolled in the TOTAL trial were stratified based on whether or not they had received any', '10,064 patients were enrolled and underwent PCI', 'patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI']","['unfractionated heparin', 'parenteral anticoagulant prior to randomization and PCI', 'Upstream anticoagulation']","['death, stroke, recurrent MI, cardiogenic shock, or congestive heart failure', 'rates of CABG and minor bleeding', 'rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI', 'death, recurrent infarction, or heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0522505', 'cui_str': 'Upstream (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",,0.198825,Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI.,"[{'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Cantor', 'Affiliation': 'Division of Cardiology, Southlake Regional Health Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Lavi', 'Affiliation': 'University of Western Ontario, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Džavík', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Asim N', 'Initials': 'AN', 'LastName': 'Cheema', 'Affiliation': ""St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Della Siega', 'Affiliation': 'Victoria Heart Institute Foundation, Victoria, British Columbia, Canada.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Stankovic', 'Affiliation': 'Clinical Center of Serbia and Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Sasko', 'Initials': 'S', 'LastName': 'Kedev', 'Affiliation': 'University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia.'}, {'ForeName': 'Madhu K', 'Initials': 'MK', 'LastName': 'Natarajan', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Levi', 'Affiliation': 'University of Western Ontario, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sanjit S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28540']
1057,31399302,Cost-effectiveness of abiraterone versus docetaxel in the treatment of metastatic hormone naïve prostate cancer.,"PURPOSE


Prostate cancer is the second leading cause of cancer death in men in the US. Since 2015, landmark studies have demonstrated improved survival outcomes with the use of docetaxel (DCT) or abiraterone (AA) in addition to androgen deprivation therapy (ADT) in the metastatic hormone-naïve setting. These treatment strategies have not been prospectively compared but have similar overall survival benefits despite differing mechanisms of action, toxicity, and cost. We performed a cost-effectiveness analysis to provide insight into the value of AA vs. DCT in the first-line treatment of metastatic prostate cancer.
MATERIALS AND METHODS


We developed Markov models by using a US-payer perspective and a 3-year time horizon to estimate costs (2018 US$) and progression-free quality-adjusted life years (PF-QALYs) for ADT alone, DCT, and AA. Health states were defined as initial state, treatment states according to experience of an adverse event, and progressed disease/death. State transition probabilities were derived from rates for drug discontinuation, frequency of adverse events, disease progression, and death from the randomized phase III trials ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) and LATITUDE. Univariate and probabilistic sensitivity analyses were conducted to evaluate model uncertainty.
RESULTS


DCT resulted in an increase of 0.32 PF-QALYs and $16,100 in cost and AA resulted in an increase of 0.52 PF-QALYs and $215,800 in cost compared to ADT alone. The incremental cost-effectiveness ratio for DCT vs. ADT was $50,500/PF-QALY and for AA vs. DCT was $1,010,000/PF-QALY. Probabilistic sensitivity analysis demonstrated that at a willingness-to-pay threshold of $150,000/PF-QALY AA was highly unlikely to be cost-effective.
CONCLUSION


DCT is substantially more cost-effective than AA in the treatment of metastatic hormone naïve prostate cancer.",2019,"The incremental cost-effectiveness ratio for DCT vs. ADT was $50,500/PF-QALY and for AA vs. DCT was $1,010,000/PF-QALY.",['metastatic hormone naïve prostate cancer'],"['DCT', 'docetaxel (DCT) or abiraterone (AA', 'abiraterone versus docetaxel']","['frequency of adverse events, disease progression, and death', 'survival outcomes', '3-year time horizon to estimate costs (2018 US$) and progression-free quality-adjusted life years (PF-QALYs) for ADT alone, DCT, and AA', 'incremental cost-effectiveness ratio']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0308113,"The incremental cost-effectiveness ratio for DCT vs. ADT was $50,500/PF-QALY and for AA vs. DCT was $1,010,000/PF-QALY.","[{'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Ramamurthy', 'Affiliation': 'Mays Cancer Center UT Health San Antonio, San Antonio, TX. Electronic address: ramamurthyc@uthscsa.edu.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Handorf', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Andres F', 'Initials': 'AF', 'LastName': 'Correa', 'Affiliation': 'MD Anderson Cancer Center at Cooper, Camden, NJ.'}, {'ForeName': 'J Robert', 'Initials': 'JR', 'LastName': 'Beck', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Geynisman', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}]",Urologic oncology,['10.1016/j.urolonc.2019.05.017']
1058,31497883,Feedback in Couple and Family Therapy: A Randomized Clinical Trial.,"Routine Outcome Monitoring (ROM) is recommended as a psychotherapy procedure to serve as clinical feedback in order to improve client treatment outcomes. ROM can work as a warning signal to the therapist if the client shows signs of no change or deterioration. This study has investigated whether any difference in outcome could be detected between those clients in couple and family therapy who used the Systemic Therapy Inventory of Change (STIC) feedback system (ROM condition) versus those who were offered treatment without the use of STIC (""treatment as usual"" or TAU condition). A sample of 328 adults seeking couple and family therapy in Norway was randomly assigned to ROM versus TAU conditions. Outcome measures were The Outcome Questionnaire-45 and The Revised Dyadic Adjustment Scale. The results demonstrated no significant differences in outcomes between the ROM and TAU. Possible explanations of this result related to design and implementation issues are discussed.",2020,"This study has investigated whether any difference in outcome could be detected between those clients in couple and family therapy who used the Systemic Therapy Inventory of Change (STIC) feedback system (ROM condition) versus those who were offered treatment without the use of STIC (""treatment as usual"" or TAU condition).",['328 adults seeking couple and family therapy in Norway'],['Routine Outcome Monitoring (ROM'],['Outcome Questionnaire-45 and The Revised Dyadic Adjustment Scale'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0222045'}]",328.0,0.042688,"This study has investigated whether any difference in outcome could be detected between those clients in couple and family therapy who used the Systemic Therapy Inventory of Change (STIC) feedback system (ROM condition) versus those who were offered treatment without the use of STIC (""treatment as usual"" or TAU condition).","[{'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Tilden', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Vikersund, Norway.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Wampold', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Vikersund, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Ulvenes', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Vikersund, Norway.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Zahl-Olsen', 'Affiliation': 'Department for Child and Adolescent Mental Health, Sorlandet Hospital, Kristiansand, Norway.'}, {'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Vikersund, Norway.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Barstad', 'Affiliation': 'Family Unit, Modum Bad Psychiatric Center, Vikersund, Norway.'}, {'ForeName': 'Iris A', 'Initials': 'IA', 'LastName': 'Olsen', 'Affiliation': 'Municipality of Arendal, Arendal, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Gude', 'Affiliation': 'Department of Behavioral Sciences in Medicine, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Pinsof', 'Affiliation': 'Pinsof Family Systems, Chicago, IL.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Zinbarg', 'Affiliation': 'Psychology Department, The Family Institute at Northwestern University, Evanston, IL.'}, {'ForeName': 'Harald H', 'Initials': 'HH', 'LastName': 'Nilssen', 'Affiliation': 'The Family Agency of Drammen and Kongsberg, Drammen, Norway.'}, {'ForeName': 'Åshild T', 'Initials': 'ÅT', 'LastName': 'Håland', 'Affiliation': 'Department for Child and Adolescent Mental Health, Sorlandet Hospital, Kristiansand, Norway.'}]",Family process,['10.1111/famp.12485']
1059,31951771,"Long-term immunogenicity and immune memory response to the hepatitis B antigen in the RTS,S/AS01 E  malaria vaccine in African children: a randomized trial.","RTS,S/AS01 E  malaria vaccine contains the hepatitis B virus surface antigen and may thus serve as a potential hepatitis B vaccine. To evaluate the impact of RTS,S/AS01 E  when implemented in the Expanded Program of Immunization, infants 8-12 weeks old were randomized to receive either RTS,S/AS01 E  or a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines: diphtheria-tetanus-acellular pertussis- Haemophilus influenzae  type b, trivalent oral poliovirus, pneumococcal non-typeable  Haemophilus influenzae  protein D conjugate and human rotavirus vaccine. Long-term persistence of antibodies against the circumsporozoite (CS) protein and hepatitis B surface antigen (HBsAg) were assessed, together with the immune memory response to the HB antigen following a booster dose of HepB vaccine. Subgroups receiving RTS,S or the HepB control vaccine were pooled into RTS,S groups and HepB groups, respectively. One month post-HepB booster vaccination, 100% of participants in the RTS,S groups and 98.3% in the control groups had anti-HBs antibody concentrations ≥10 mIU/mL with the geometric mean concentrations (GMCs) at 46634.7 mIU/mL (95% CI: 40561.3; 53617.6) and 9258.2 mIU/mL (95% CI: 6925.3; 12377.0), respectively. Forty-eight months post-primary vaccination anti-CS antibody GMCs ranged from 2.3 EU/mL to 2.7 EU/mL in the RTS,S groups compared to 1.1 EU/mL in the control groups. Hepatitis B priming with the RTS,S/AS01 E  vaccine was effective and resulted in a memory response to HBsAg as shown by the robust booster response following an additional dose of HepB vaccine. RTS,S/AS01E when co-administered with PHiD-CV, HRV and other childhood vaccines, had an acceptable safety profile.",2020,"Hepatitis B priming with the RTS,S/AS01 E  vaccine was effective and resulted in a memory response to HBsAg as shown by the robust booster response following an additional dose of HepB vaccine.","['African children', 'infants 8-12\xa0weeks old']","['diphtheria-tetanus-acellular pertussis- Haemophilus influenzae', 'RTS,S/AS01 E  or a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines']",['anti-HBs antibody concentrations ≥10'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3540029', 'cui_str': 'various other anti-acne preparation combinations for topical use in ATC'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0948254', 'cui_str': 'Anti-HBs antibody'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0415345,"Hepatitis B priming with the RTS,S/AS01 E  vaccine was effective and resulted in a memory response to HBsAg as shown by the robust booster response following an additional dose of HepB vaccine.","[{'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Valéa', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Adjei', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Effua', 'Initials': 'E', 'LastName': 'Usuf', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Traore', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ansong', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Owusu Boateng', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Athanase Mwinessobaonfou', 'Initials': 'AM', 'LastName': 'Some', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Buabeng', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vekemans', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Kotey', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Vandoolaeghe', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cullinane', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ouedraogo', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sambian', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lievens', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Marc Christian', 'Initials': 'MC', 'LastName': 'Tahita', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Palpouguini', 'Initials': 'P', 'LastName': 'Lompo', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Idriss', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Sayouba', 'Initials': 'S', 'LastName': 'Ouedraogo', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Prempeh', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Lode', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Tsiri', 'Initials': 'T', 'LastName': 'Agbenyega', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1695457']
1060,32433779,Predictors of Systemic Exposure to Topical Crisaborole: A Nonlinear Regression Analysis.,"Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis. Results from 2 randomized, double-blind, vehicle-controlled phase 3 studies showed that twice-daily crisaborole in children and adults with mild to moderate atopic dermatitis was efficacious and well tolerated. Initial pharmacokinetics (PK) studies of crisaborole indicated absorption with measurable systemic levels of crisaborole. The current analysis was conducted to correlate steady-state systemic exposure parameters with ointment dose and identify covariates impacting PK parameters in healthy participants and patients with atopic dermatitis or psoriasis. A nonlinear regression analysis was conducted using ointment dose and noncompartmental PK parameters at steady state (area under the curve [AUC ss  ] and maximum concentration [C max,ss  ]). PK data were available from 244 participants across 6 clinical studies (AUC ss  , N = 239; C max,ss  , N = 241). Disease condition had the greatest impact on slope in both models, corresponding to 2.5-fold higher AUC ss  and C max,ss  values at a given ointment dose in patients with atopic dermatitis or psoriasis relative to healthy participants. Disease severity, race/ethnicity, and sex had marginal effects on AUC ss  and C max,ss  . Systemic exposures were similar across age groups ≥2 years of age when the same percentage of body surface area (%BSA) was treated. Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data. Model predictions indicated that systemic exposure to crisaborole in pediatric patients (2-17 years) is unlikely to exceed systemic exposure in adults (≥18 years), even at the highest possible ointment dose corresponding to a %BSA of 90.",2020,"Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data.","['children and adults with mild to moderate atopic dermatitis', 'healthy participants and patients with atopic dermatitis or psoriasis', 'pediatric patients (2-17\xa0years', '244 participants across 6 clinical studies (AUC ss  , N = 239; C max,ss  , N = 241', 'mild to moderate atopic dermatitis', 'patients with atopic dermatitis or psoriasis relative to healthy participants']","['Crisaborole ointment', 'Topical Crisaborole']","['efficacious and well tolerated', 'Systemic exposures']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C4301784', 'cui_str': 'crisaborole Topical Ointment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4301781', 'cui_str': 'crisaborole'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0366952,"Predictive performance plots for AUC ss  and C max,ss  for different age groups demonstrated that the models adequately describe the observed data.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Purohit', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1624']
1061,32433835,"Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study.","OBJECTIVE


Evaluate efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) with 1-day initiation during hospitalization for acute exacerbation of schizophrenia followed by transition to outpatient care.
METHODS


The phase 3b double-blind Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness (ALPINE) study was conducted from November 2017 to March 2019. Adults with acute schizophrenia according to DSM-5 criteria were randomized (1:1) to AL (AL NanoCrystal Dispersion + oral aripiprazole 30 mg, day 1; AL 1,064 mg, day 8 and every 8 weeks [q8wk]) or paliperidone palmitate (PP 234 mg, day 1; PP 156 mg, day 8 and then q4wk) for 25 weeks. Patients remained hospitalized ≥ 2 weeks after randomization per protocol. Primary endpoint was within-group change in Positive and Negative Syndrome Scale total score (PANSST) from baseline to week 4. Secondary analyses included within- and between-group changes from baseline at various time points. Adverse events (AEs) and laboratory data were monitored.
RESULTS


A total of 200 patients were randomized (AL, n = 99; PP, n = 101); 56.6% and 42.6%, respectively, completed the study. For AL, the mean baseline PANSST was 94.1; scores were significantly reduced from baseline at week 4 (-17.4; P < .001) and were also reduced at weeks 9 (-19.8) and 25 (-23.3). With PP, PANSST also improved significantly from baseline (94.6) at week 4 (-20.1; P < .001) and also improved at weeks 9 (-22.5) and 25 (-21.7). The 3 most common AEs over 25 weeks in the AL group were injection site pain (17.2%), increased weight (9.1%), and akathisia (9.1%). The same AEs were the most common in the PP group (injection site pain [24.8%], increased weight [16.8%], and akathisia [10.9%]).
CONCLUSIONS


AL and PP were efficacious and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing outpatient treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03345979.",2020,"For AL, the mean baseline PANSST was 94.1; scores were significantly reduced from baseline at week 4 (-17.4; P < .001) and were also reduced at weeks 9 (-19.8) and 25 (-23.3).","['Adults with acute schizophrenia according to DSM-5 criteria', 'Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care', 'November 2017 to March 2019', '200 patients were randomized (AL, n = 99; PP, n = 101); 56.6% and 42.6%, respectively, completed the study']","['Aripiprazole Lauroxil With 1-Day Initiation', 'paliperidone palmitate', 'Aripiprazole Lauroxil and Paliperidone palmitate', 'lauroxil (AL) with 1-day initiation', 'aripiprazole', 'AL (AL NanoCrystal Dispersion + oral aripiprazole']","['Efficacy and Safety', 'increased weight', 'Positive and Negative Syndrome Scale total score (PANSST', 'Adverse events (AEs) and laboratory data', 'akathisia', 'injection site pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C2719626', 'cui_str': 'Paliperidone palmitate'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1721058', 'cui_str': 'Nanocrystals'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}]",200.0,0.518152,"For AL, the mean baseline PANSST was 94.1; scores were significantly reduced from baseline at week 4 (-17.4; P < .001) and were also reduced at weeks 9 (-19.8) and 25 (-23.3).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Karuna Therapeutics, 33 Arch Street, Suite 3110, Boston, MA 02110. pjweiden@gmail.com.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Claxton', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Kunovac', 'Affiliation': 'Altea Research, Las Vegas, Nevada, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Walling', 'Affiliation': 'CNS Network, LLC, Garden Grove, California, USA.'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Baiyun', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Yagoda', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Ilda', 'Initials': 'I', 'LastName': 'Bidollari', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Keane', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Cash', 'Affiliation': 'Alkermes, Inc, Waltham, Massachusetts, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13207']
1062,32434104,Effect of the mobile phone-related background on inhibitory control of problematic mobile phone use: An event-related potentials study.,"The present study aims to provide electrophysiological evidence for deficient inhibitory control in problematic mobile phone use and to investigate whether reduced inhibition is more pronounced during exposure to a mobile phone related background cue. A screen scale of smartphone addiction was completed by 227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study. Event-related potentials were recorded during a backgrounded Go/NoGo task performed by those two groups, in which either a frequent Go signal (letter ""M"") or a rare NoGo signal (letter ""W"") was superimposed on three different background cues: neutral, mobile phone application-related and mobile phone using-related pictures. Results showed that problematic mobile phone users performed more commission errors than controls following mobile phone application background. Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background. The result might suggest that there is no general impairment of inhibitory control in problematic mobile phone use. The deficient inhibitory control on behavioral and psychophysiological level appeared merely in the mobile phone-related background. Such deficient stimuli-specific inhibitory control appears at the late stage of inhibitory control. Prevention programs should be designed to curtail exposure to the mobile phone-related stimulus and enhance cognitive control of potential problematic mobile phone users.",2020,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","['227 college students, and finally an experimental group and a control group consisting of 20 problematic mobile phone users and 19 controls were included in the study']",['mobile phone-related background'],"['behavioral and psychophysiological level', 'commission errors', 'NoGo P3 amplitude']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0394788,"Furthermore, problematic mobile phone users displayed a weaker NoGo P3 amplitude than controls on the mobile phone application background.","[{'ForeName': 'Lingfeng', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Jingfu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Qingbai', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China.'}, {'ForeName': 'Zongkui', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior (CCNU), Ministry of Education, Wuhan 430079, China; School of Psychology, Central China Normal University, Wuhan 430079, China. Electronic address: zhouzk@mail.ccnu.edu.cn.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106363']
1063,31835994,Comparison of sciatic nerve block quality achieved using the anterior and posterior approaches: a randomised trial.,"BACKGROUND


The co-administration of sciatic and femoral nerve blocks can provide anaesthesia and analgesia in patients undergoing lower extremity surgeries. Several approaches to achieve sciatic nerve block have been described, including anterior and posterior approaches.
METHODS


In total, 58 study patients were randomly assigned to receive either anterior (group A, n = 29) or posterior (group P, n = 29) sciatic nerve block. Thereafter, the following parameters were determined: sensory and motor block start and end times, time to first fentanyl requirement after blockade but before the start of the operation, time to first fentanyl requirement after the start of the operation, mean fentanyl dose administered after blockade but before the start of the operation, mean fentanyl dose after the start of the operation, time to first diclofenac sodium dose, and total dose of diclofenac sodium required. The trial was retrospectively registered on 11 July 2018.
RESULTS


The time to initiation of sensory block was significantly shorter in group P than in group A (7.70 ± 2.05 min and 12.88 ± 4.87 min, respectively; p = 0.01). Group P also had a significantly shorter time to first fentanyl requirement after block but before the start of the operation (00.00 ± 00.00 min for group P and 4.05 ± 7.47 min for group A; p < 0.01), significantly higher mean fentanyl dose per patient after block but before the start of the operation (44.03 ± 23.78 μg for group P and 31.20 ± 27.79 μg for group A), significantly longer time to first fentanyl requirement after the start of the operation (16.24 ± 7.13 min for group P and 00.00 ± 00.00 min for group A; p = 0.01), and significantly lower mean fentanyl dose per patient after the start of the operation (11.51 ± 2.87 μg for group P and 147.75 ± 22.30 μg for group A). Patient satisfaction (p < 0.01), anaesthesia quality (p = 0.006), and surgical quality (p = 0.047) were significantly higher in group P.
CONCLUSIONS


Anterior and posterior approaches can be used to achieve sciatic nerve block in patients undergoing surgery for malleolar fractures. However, better anaesthesia and pain control results can be obtained if analgesia is administered preoperatively in patients with a posterior approach block and after the start of the operation in patients with an anterior approach block.",2019,"Patient satisfaction (p < 0.01), anaesthesia quality (p = 0.006), and surgical quality (p = 0.047) were significantly higher in group P.
CONCLUSIONS


Anterior and posterior approaches can be used to achieve sciatic nerve block in patients undergoing surgery for malleolar fractures.","['11 July 2018', 'patients undergoing lower extremity surgeries', 'patients undergoing surgery for malleolar fractures', '58 study patients']","['diclofenac sodium', 'sciatic and femoral nerve blocks']","['anaesthesia quality', 'time to initiation of sensory block', 'surgical quality', 'sensory and motor block start and end times, time to first fentanyl requirement after blockade', 'Patient satisfaction', 'shorter time to first fentanyl requirement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",58.0,0.0427194,"Patient satisfaction (p < 0.01), anaesthesia quality (p = 0.006), and surgical quality (p = 0.047) were significantly higher in group P.
CONCLUSIONS


Anterior and posterior approaches can be used to achieve sciatic nerve block in patients undergoing surgery for malleolar fractures.","[{'ForeName': 'Abdulkadir', 'Initials': 'A', 'LastName': 'Yektaş', 'Affiliation': 'Department of Anesthesiology and Reanimation, Republic of Turkey Health Sciences Univercity Diyarbakır Gazi Yaşargil Training and Research Hospital, Kayapınar Mahallesi Diayarbakır, Turkey. akyektas@hotmail.com.'}, {'ForeName': 'Bedih', 'Initials': 'B', 'LastName': 'Balkan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Republic of Turkey Health Sciences Univercity Istanbul Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey.'}]",BMC anesthesiology,['10.1186/s12871-019-0898-0']
1064,31444180,PCASTt/SPCG-17-a randomised trial of active surveillance in prostate cancer: rationale and design.,"INTRODUCTION


Overtreatment of localised prostate cancer is substantial despite increased use of active surveillance. No randomised trials help define how to monitor patients or when to initiate treatment with curative intent.
METHODS AND ANALYSIS


A randomised, multicentre, intervention trial designed to evaluate the safety of an MRI-based active surveillance protocol, with standardised triggers for repeated biopsies and radical treatment. The aim is to reduce overtreatment of prostate cancer. 2000 men will be randomly allocated to either surveillance according to current practice or to standardised triggers at centres in Sweden, Norway, Finland and the UK. Men diagnosed in the past 12 months with prostate cancer, ≤T2a, prostate-specific antigen (PSA) <15 ng/mL, PSA density ≤0.2 ng/mL/cc, any International Society of Urological Pathology (ISUP) grade 1 are eligible. Men with ISUP grade 2 in <30% of cores on systematic biopsy and <10 mm cancer in one core on systematic or targeted biopsy are also eligible. Men diagnosed on systematic biopsy should have an MRI and targeted biopsies against Prostate Imaging and Reporting Data System V.2 3-5 lesions before inclusion. Identical follow-up in the two study arms: biannual PSA testing, yearly clinical examination and MRI every second year. In the experimental arm, standardised triggers based on MRI and PSA density elicit repeated biopsies. MRI and histopathological progression trigger radical treatment. Primary outcome measure is progression-free survival. Secondary outcome measures are cumulative incidence of metastatic disease, treatments with curative intent, pT3-4 at radical prostatectomy, switch to watchful waiting, prostate cancer mortality and quality of life. Inclusion started in October 2016 and in October 2018; 275 patients have been enrolled.
ETHICS AND DISSEMINATION


Ethical approval was obtained in each participating country. Results for the primary and secondary outcome measures will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT02914873.",2019,Men with ISUP grade 2 in <30% of cores on systematic biopsy and <10 mm cancer in one core on systematic or targeted biopsy are also eligible.,"['prostate cancer', '2000 men', 'Inclusion started in October 2016 and in October 2018; 275 patients have been enrolled', 'Men diagnosed in the past 12 months with prostate cancer, ≤T2a, prostate-specific antigen (PSA) <15\u2009ng/mL, PSA density ≤0.2\u2009ng/mL/cc, any International Society of Urological Pathology (ISUP) grade 1 are eligible', 'Men with ISUP grade 2 in <30% of cores on systematic biopsy and <10\u2009mm cancer']","['MRI-based active surveillance protocol', 'surveillance according to current practice or to standardised triggers at centres in Sweden, Norway, Finland and the UK']","['cumulative incidence of metastatic disease, treatments with curative intent, pT3-4 at radical prostatectomy, switch to watchful waiting, prostate cancer mortality and quality of life', 'progression-free survival', 'submitted for publication in peer-reviewed journals']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0034036', 'cui_str': 'Publications'}, {'cui': 'C0030768', 'cui_str': 'Peer Review'}]",2000.0,0.281725,Men with ISUP grade 2 in <30% of cores on systematic biopsy and <10 mm cancer in one core on systematic or targeted biopsy are also eligible.,"[{'ForeName': 'Mats Steinholtz', 'Initials': 'MS', 'LastName': 'Ahlberg', 'Affiliation': 'Uppsala Universitet Institutionen for Kirurgiska Vetenskaper, Uppsala, Sweden mats.ahlberg@surgsci.uu.se.'}, {'ForeName': 'Hans-Olov', 'Initials': 'HO', 'LastName': 'Adami', 'Affiliation': 'Karolinska Institutet Department of Medical Epidemiology and Biostatistics, Stockholm, Sweden.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Beckmann', 'Affiliation': ""King's College London Translational Oncology and Urology Research, London, UK.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Bertilsson', 'Affiliation': 'Department of Urology, Sankt Olavs Hospital Universitetssykehuset i Trondheim, Trondheim, Norway.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Bratt', 'Affiliation': 'Department of Urology, Goteborgs universitet Sahlgrenska Akademin, Goteborg, Sweden.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Cahill', 'Affiliation': 'The Royal Mardsen Hospital, London, London, UK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Egevad', 'Affiliation': 'Department of Pathology, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Garmo', 'Affiliation': ""School of Cancer & Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': 'Regional Cancer Centre Uppsala/Örebro, Uppsala, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johansson', 'Affiliation': 'Uppsala Universitet Institutionen for Kirurgiska Vetenskaper, Uppsala, Sweden.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Rannikko', 'Affiliation': 'Helsinki University and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': 'Translational Oncology & Urology Offices, Kings College London, London, UK.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Jäderling', 'Affiliation': 'Radiology Department, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Wassberg', 'Affiliation': 'Radiology Department, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Ulrika W N', 'Initials': 'UWN', 'LastName': 'Åberg', 'Affiliation': 'Uppsala Universitet Institutionen for Kirurgiska Vetenskaper, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bill-Axelson', 'Affiliation': 'Uppsala Universitet Institutionen for Kirurgiska Vetenskaper, Uppsala, Sweden.'}]",BMJ open,['10.1136/bmjopen-2018-027860']
1065,31427345,Subcutaneous sumatriptan for the treatment of postcraniotomy pain (SUPS trial): protocol for a randomised double-blinded placebo controlled trial.,"INTRODUCTION


Postcraniotomy pain protocols use opioids, which are considered suboptimal analgesia following this procedure. Multimodal analgesia components are sparse. Our null hypothesis states that sumatriptan is not different to placebo in addition to usual intravenous opioids, for the treatment of acute postcraniotomy pain.
METHODS AND ANALYSIS


This is a prospective single-centre randomised double-blinded placebo-controlled phase III clinical trial comparing subcutaneous sumatriptan injection in the recovery area with placebo for the treatment of postcraniotomy pain. Eligible adult patients (18 years and older) undergoing craniotomy will be identified preoperatively. Both patient groups will receive a subcutaneous injection at a point where recovery-nursing staff would initiate the usual intravenous opioid analgesia as per standardised pain management protocol. In both groups, further pain management will be followed by the usual intravenous opioid administration. Primary outcome will consist of the difference in pain experienced by the two groups of patients in recovery area 60 min after the study drug administration. Postcraniotomy pain will be measured at regular intervals using the Visual Analogue Scale (VAS) in recovery area. The minimal clinically important difference of 10 mm on the VAS between the two groups will be considered as statistically significant. We will include selected clinical and patient-reported outcomes as secondary endpoints. Univariate regression will be conducted on each one of the clinically plausible potential confounders. We will enrol a total 136 patients, with the study duration of 2 years. This trial will commence recruitment on the 1 July 2019.
ETHICS AND DISSEMINATION


This trial protocol has achieved approval by the Austin Health Research Committee, HREC/17/Austin/596. This trial was prospectively registered with Australian New Zealand Clinical Trials Registry on the 10/05/2018 with a unique trial identifier U1111-1209-9072 and registration Number ACTRN12618000793213P. Findings of this study will be disseminated in peer-reviewed academic journals.
TRIAL REGISTRATION NUMBER


U1111-1209-9072, ACTRN12618000793213P.",2019,Primary outcome will consist of the difference in pain experienced by the two groups of patients in recovery area 60 min after the study drug administration.,"['postcraniotomy pain', 'Eligible adult patients (18 years and older) undergoing craniotomy will be identified preoperatively', 'total 136 patients, with the study duration of 2 years']","['sumatriptan', 'Subcutaneous sumatriptan', 'placebo', 'subcutaneous sumatriptan injection']","['Postcraniotomy pain', 'pain', 'Visual Analogue Scale (VAS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4033853', 'cui_str': 'Sumatriptan Injection [Imitrex]'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",136.0,0.620492,Primary outcome will consist of the difference in pain experienced by the two groups of patients in recovery area 60 min after the study drug administration.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Licina', 'Affiliation': 'Anaesthesia, Austin Health, Heidelberg, Victoria, Australia analicina@hotmail.com.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'Neurosurgery, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Silvers', 'Affiliation': 'Anesthesia, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Neurosurgery, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Denny', 'Affiliation': 'Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032388']
1066,31462735,MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.,"We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.",2020,patients receiving Benda alone (p = 0.0029).,"['rituximab-refractory follicular lymphoma (FL', 'Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement']","['obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone', 'bendamustine']","['MRD response', 'progression-free survival', 'overall survival']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0473059,patients receiving Benda alone (p = 0.0029).,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Hospital of the Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Kehden', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harbron', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mundt', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wassner-Fritsch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}]",Leukemia,['10.1038/s41375-019-0559-9']
1067,32048890,"Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan.","BACKGROUND


The study was aimed at comparative evaluation of seasonal influenza vaccine RIBSP versus commercial vaccine VAXIGRIP® for immunogenicity and safety in the course of clinical trial phase II on healthy subjects up to 60 years.
METHODS


The trial involved 150 subjects in randomized 2:1 groups that received either RIBSP vaccine or comparator vaccine VAXIGRIP®. One dose (0.5 ml) of either vaccine contained 15 µg of hemagglutinin of each influenza virus strain recommended by WHO for the Northern hemisphere in 2016-2017 flu season. The observation period lasted 21 days. The trial was registered at ClinicalTrials.gov identifier NCT03016143.
RESULTS


Assessment of immunogenic activity of the vaccine under study showed that in 21 days the portion of participants with 4-fold seroconversions was 80.0% to А/H1N1; 65.0% to А/H3N2 and 64.0% to B virus. Antibody titer increase factor in the group of subjects that received RIBSP vaccine was 13.4 for А/H1N1; 5.2 for А/H3N2 and 5.2 for B virus. The subjects that received RIBSP vaccine demonstrated 88% seroprotection rate against А/H1N1; 75% against А/H3N2 and 61% against B virus. In the course of evaluating the vaccine safety, no serious adverse events were recorded. All changes of laboratory data were slight and single in most cases. All recorded local reactions have been light in character and these have been predicted reactions observed at vaccination against influenza.
CONCLUSION


Comparison vaccines RIBSP and VAXIGRIP®, showed similar immunogenic activity. The RIBSP vaccine is safe and immunogenic for the elderly and conforms to international criteria in CPMP/BWP/214/96.",2020,The subjects that received RIBSP vaccine demonstrated 88% seroprotection rate against А/H1N1; 75% against А/H3N2 and 61% against B virus.,"['150 subjects', 'healthy subjects up to 60 years', 'adults 60 years of age and older']","['RIBSP vaccine or comparator vaccine VAXIGRIP®', 'seasonal influenza vaccine RIBSP versus commercial vaccine VAXIGRIP®', 'vaccine', 'trivalent inactivated influenza vaccine', 'RIBSP vaccine']","['seroprotection rate against А/H1N1', 'Antibody titer increase factor', 'immunogenic activity', 'Safety and immunogenicity', 'immunogenicity and safety']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1312593', 'cui_str': 'vaxigrip'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",150.0,0.0389856,The subjects that received RIBSP vaccine demonstrated 88% seroprotection rate against А/H1N1; 75% against А/H3N2 and 61% against B virus.,"[{'ForeName': 'Gulbanu', 'Initials': 'G', 'LastName': 'Sarsenbayeva', 'Affiliation': 'Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Issagulov', 'Affiliation': 'Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.'}, {'ForeName': 'Markhabat', 'Initials': 'M', 'LastName': 'Kassenov', 'Affiliation': 'Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Abitay', 'Affiliation': 'Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.'}, {'ForeName': 'Mukhit', 'Initials': 'M', 'LastName': 'Orynbayev', 'Affiliation': 'Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Stukova', 'Affiliation': 'Influenza Research Institute , St. Petersburg, Russian Federation.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pisareva', 'Affiliation': 'Influenza Research Institute , St. Petersburg, Russian Federation.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Davlyatshin', 'Affiliation': 'Clinical Laboratory «T-Helper» , Almaty, Kazakhstan.'}, {'ForeName': 'Kutumbetov', 'Initials': 'K', 'LastName': 'Lespek', 'Affiliation': 'Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.'}, {'ForeName': 'Berik', 'Initials': 'B', 'LastName': 'Khairullin', 'Affiliation': 'Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1705691']
1068,32016387,Radiomics Response Signature for Identification of Metastatic Colorectal Cancer Sensitive to Therapies Targeting EGFR Pathway.,"BACKGROUND


The authors sought to forecast survival and enhance treatment decisions for patients with liver metastatic colorectal cancer by using on-treatment radiomics signature to predict tumor sensitiveness to irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) alone (F) or in combination with cetuximab (FC).
METHODS


We retrospectively analyzed 667 metastatic colorectal cancer patients treated with F or FC. Computed tomography quality was classified as high (HQ) or standard (SD). Four datasets were created using the nomenclature (treatment) - (quality). Patients were randomly assigned (2:1) to training or validation sets: FCHQ: 78:38, FCSD: 124:62, FHQ: 78:51, FSD: 158:78. Four tumor-imaging biomarkers measured quantitative radiomics changes between standard of care computed tomography scans at baseline and 8 weeks. Using machine learning, the performance of the signature to classify tumors as treatment sensitive or treatment insensitive was trained and validated using receiver operating characteristic (ROC) curves. Hazard ratio and Cox regression models evaluated association with overall survival (OS).
RESULTS


The signature (area under the ROC curve [95% confidence interval (CI)]) used temporal decrease in tumor spatial heterogeneity plus boundary infiltration to successfully predict sensitivity to antiepidermal growth factor receptor therapy (FCHQ: 0.80 [95% CI = 0.69 to 0.94], FCSD: 0.72 [95% CI = 0.59 to 0.83]) but failed with chemotherapy (FHQ: 0.59 [95% CI = 0.44 to 0.72], FSD: 0.55 [95% CI = 0.43 to 0.66]). In cetuximab-containing sets, radiomics signature outperformed existing biomarkers (KRAS-mutational status, and tumor shrinkage by RECIST 1.1) for detection of treatment sensitivity and was strongly associated with OS (two-sided P < .005).
CONCLUSIONS


Radiomics response signature can serve as an intermediate surrogate marker of OS. The signature outperformed known biomarkers in providing an early prediction of treatment sensitivity and could be used to guide cetuximab treatment continuation decisions.",2020,The signature outperformed known biomarkers in providing an early prediction of treatment-sensitivity and could be used to guide cetuximab treatment continuation decisions.,"['patients with colorectal cancer liver metastases (mCRC', '667 mCRC patients treated with']","['training or validation sets: FCHQ: 78:38, FCSD: 124:62, FHQ', 'FOLFIRI alone [F] or in combination with cetuximab [FC']","['Hazard Ratio (HR) and Cox Regression models evaluated association with overall survival (OS', 'CT quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",667.0,0.0338173,The signature outperformed known biomarkers in providing an early prediction of treatment-sensitivity and could be used to guide cetuximab treatment continuation decisions.,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Dercle', 'Affiliation': 'Department of Radiology, New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Department of Radiology, New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Department of Biostatistics, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Molecular Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eggleton', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Binsheng', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Piessevaux', 'Affiliation': 'Department of Hepato-Gastroenterology, Cliniques Universitaires Saint-Luc, UCLouvain Brussels, Brussels, Belgium.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa017']
1069,12585100,[Clinical and experimental study on retardation of immunosenescence by kidney tonifying principle].,"OBJECTIVE


To observe the clinical curative effect of Kidney tonifying method on retardation of immunosenescence and corresponding experimental study.
METHODS


A randomized double blind placebo-controlled trial was used (RCT) on 22 pairs of aged subjects to elucidate the effect of Kidney tonifying recipe on the peripheral T-lymphocyte apoptosis and the Fas/FasL gene expression in them. In rats experimental study, the effects of two kinds of Chinese recipes (Kidney tonifying recipe and blood circulation promoting recipe) on the same parameters as in clinical study as well as on cell apoptosis and gene expression regulation in old rats were also observed.
RESULTS


Clinical study showed that after treatment, the percentage of T-lymphocyte apoptosis and the FasL gene expression in the Kidney tonifying group of aged subjects were lower than those in the placebo group (P < 0.01). Animal experiment showed the same result as shown in clinical study in Kidney tonifying recipe treated rats, but not shown in those treated with blood circulation promoting recipe statistically.
CONCLUSION


Kidney tonifying principle has down-regulating effect on the transcription of apoptotic gene in both aged persons and old rats, this is one of the molecular mechanisms of Kidney tonifying method in decreasing over-apoptosis in aged subjects and old rats.",2002,"RESULTS


Clinical study showed that after treatment, the percentage of T-lymphocyte apoptosis and the FasL gene expression in the Kidney tonifying group of aged subjects were lower than those in the placebo group (P < 0.01).","['22 pairs of aged subjects', 'old rats', 'aged persons and old rats', 'aged subjects and old rats']","['Chinese recipes (Kidney tonifying recipe and blood circulation promoting recipe', 'placebo', 'Kidney tonifying recipe']","['percentage of T-lymphocyte apoptosis and the FasL gene expression', 'peripheral T-lymphocyte apoptosis and the Fas/FasL gene expression', 'cell apoptosis and gene expression regulation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0005775', 'cui_str': 'Blood Circulation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0017263', 'cui_str': 'Gene Action Regulation'}]",22.0,0.0417798,"RESULTS


Clinical study showed that after treatment, the percentage of T-lymphocyte apoptosis and the FasL gene expression in the Kidney tonifying group of aged subjects were lower than those in the placebo group (P < 0.01).","[{'ForeName': 'Zi-yin', 'Initials': 'ZY', 'LastName': 'Shen', 'Affiliation': 'Institute of Integrated Traditional Chinese and Western Medicine, Medical Center of Fudan University, Shanghai 200040.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Wei-min', 'Initials': 'WM', 'LastName': 'Guo', 'Affiliation': ''}]",Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine,[]
1070,30859515,High Prevalence of Undiagnosed Hyperglycemia in Low-Income Overweight and Obese Hispanic Women in Oregon.,"BACKGROUND


Overweight Hispanic women are at high risk for type 2 diabetes. A clinical diagnosis of hyperglycemia is often necessary to access interventions. We examined the prevalence of undiagnosed hyperglycemia among a group of low-income overweight or obese Hispanic women, who were receiving care at a Federally Qualified Health Center (FQHC).
METHODS


Among 196 overweight or obese Hispanic women (mean age 44 ± 10 years, mean weight 86.8 ± 16.5 kg, mean body mass index [BMI] 36.5 ± 6.4 kg/m 2 ) enrolled in a randomized clinical weight-loss trial, we compared A1C and fasting blood glucose (FBG) obtained at baseline with women's existing diabetes and prediabetes diagnoses in the medical record.
RESULTS


According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis. Among participants without a diagnosis of diabetes or prediabetes during the baseline screening for our study, 63% (55/87) had at least one test in the prediabetes range (baseline A1C and FBG were in prediabetes range for 39 and 55 participants, respectively), and 13% (11/87) had at least one test in the diabetic range (baseline A1C and FBG values in diabetes range for 3 and 11 participants, respectively).
DISCUSSION


We found substantial prevalence of undiagnosed hyperglycemia among a sample of overweight and obese Hispanic women. It is possible that limited awareness of diabetes risk may be a barrier to patient compliance with screening recommendations.",2019,"According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis.","['undiagnosed hyperglycemia among a group of low-income overweight or obese Hispanic women, who were receiving care at a Federally Qualified Health Center (FQHC', 'participants without a diagnosis of diabetes or prediabetes during the baseline screening for our study, 63% (55/87) had at least one test in the', 'Overweight Hispanic women', 'Low-Income Overweight and Obese Hispanic Women in Oregon', 'overweight and obese Hispanic women', '196 overweight or obese Hispanic women (mean age 44\u2009±\u200910\xa0years, mean weight 86.8\u2009±\u200916.5\xa0kg, mean body mass index', ""participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis""]",[],"['prediabetes range (baseline A1C and FBG', 'diabetic range (baseline A1C and FBG values', 'undiagnosed hyperglycemia', 'Undiagnosed Hyperglycemia', 'A1C and fasting blood glucose (FBG']","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],"[{'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",196.0,0.0531146,"According to the information in participants' medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis.","[{'ForeName': 'Nangel M', 'Initials': 'NM', 'LastName': 'Lindberg', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA. Nangel.M.Lindberg@kpchr.org.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Stevens', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gille', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Arias-Gastélum', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shuster', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Vaughn', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Meagan C', 'Initials': 'MC', 'LastName': 'Shaw', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Ave., Portland, OR, 97227, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Virginia Garcia Memorial Health Center, Cornelius, OR, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00578-9']
1071,32439224,Effect of Vehicle and Agitation Methods on the Penetration of Calcium Hydroxide Paste in the Dentinal Tubules.,"INTRODUCTION


The aim of this ex vivo study was to analyze the effect of different vehicles combined with agitation methods on the penetration of calcium hydroxide (CH) paste in the dentinal tubules.
METHODS


Sixty freshly extracted, single-rooted human premolars were prepared using WaveOne Gold (Dentsply Sirona, York, PA) and randomized into 6 experimental groups (n = 10) according to the vehicle and method of paste agitation as follows: propylene glycol (PG) + Lentulo, PG + Lentulo + ultrasound, PG + Lentulo + sonic, distilled water (DW) + Lentulo, DW + Lentulo + ultrasonic, and DW + Lentulo + sonic. The CH paste was manipulated with sodium fluorescein dye and was inserted to completely fill the root canal. Two 1-mm thick sections at 2 mm and 5 mm from the apex of each root were obtained. The sections were scanned using confocal laser scanning microscopy, and the images were analyzed using ImageJ software (Bethesda, MD) to calculate the percentage penetration and maximum penetration depth of CH paste. Statistical analysis was performed using 1-way analysis of variance and Tukey honestly significant difference post hoc tests.
RESULTS


No statistically significant differences between study factors at a distance of 2 mm from the apex were observed (P > .05). However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG.
CONCLUSIONS


Vehicles interfered with the penetration of CH in the dentinal tubules at 5 mm from the apex with better results for PG.",2020,"However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG.
","['Sixty freshly extracted, single-rooted human premolars']","['Vehicle and Agitation Methods', 'sodium fluorescein dye', 'WaveOne Gold (Dentsply Sirona, York, PA', 'calcium hydroxide', 'paste agitation as follows: propylene glycol (PG) + Lentulo, PG + Lentulo + ultrasound, PG + Lentulo + sonic, distilled water (DW) + Lentulo, DW + Lentulo + ultrasonic, and DW + Lentulo + sonic']",['Penetration of Calcium Hydroxide Paste'],"[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0147866', 'cui_str': 'Fluorescein sodium stain'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}]",60.0,0.0523159,"However, at 5 mm, a significant difference between the vehicles (P < .05) in percentage penetration was demonstrated with higher means for PG.
","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'de Almeida Barbosa', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Kauhanna Vianna', 'Initials': 'KV', 'LastName': 'de Oliveira', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Vinícius Rodrigues', 'Initials': 'VR', 'LastName': 'Dos Santos', 'Affiliation': 'Piracicaba Dental School, Universidade Estadual de Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Wander José', 'Initials': 'WJ', 'LastName': 'da Silva', 'Affiliation': 'Piracicaba Dental School, Universidade Estadual de Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Flávia Sens Fagundes', 'Initials': 'FSF', 'LastName': 'Tomazinho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Flares', 'Initials': 'F', 'LastName': 'Baratto-Filho', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Marilisa Carneiro Leão', 'Initials': 'MCL', 'LastName': 'Gabardo', 'Affiliation': 'School of Health Sciences, Universidade Positivo, Curitiba, Paraná, Brazil. Electronic address: marilisagabardo@gmail.com.'}]",Journal of endodontics,['10.1016/j.joen.2020.03.026']
1072,32434204,"A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study.","BACKGROUND/AIMS


Both high-dose atorvastatin and rosuvastatin have been shown to reduce contrast-induced acute kidney injury (AKI) occurrence and improve clinical outcomes in high-risk coronary patients undergoing angiographic procedures. However, there is a lack of head-to-head comparative studies on the effects of atorvastatin or rosuvastatin administered upon hospital admission in statin-naive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS).
METHODS


In this open-label, noninferiority study, we compared changes in renal function in 709 NSTE-ACS patients randomized to atorvastatin (80 mg upon admission followed by 40 mg/day) or rosuvastatin (40 mg upon admission followed by 20 mg/day). The primary end point was AKI (increase in serum creatinine ≥0.5 mg/dL or ≥25% above baseline within 72 h). Worsening renal function (WRF) (decrease of ≥25% in the glomerular filtration rate from baseline to 30 days), 30-day major adverse cardiovascular events, and 12-month myocardial infarction (MI) or death were also evaluated.
RESULTS


The AKI incidence was similar in the 2 groups (i.e., 8.2% with rosuvastatin and 7.6% with atorvastatin; absolute risk difference = 0.54; 90% CI -3.9 to 2.8), satisfying the noninferiority criteria. WRF occurred in 53 (7.5%) patients, 19 (34%) of whom had developed AKI. The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups. Both AKI and WRF were found to be closely associated with the 12-month cardiovascular outcome irrespectively of statin choice.
CONCLUSIONS


High-dose rosuvastatin or atorvastatin started upon hospital admission led to similar rates of AKI, 30-day renal function changes, and 12-month death or MI in NSTE-ACS patients who underwent an early invasive strategy (clinical trial registration: https://www.clinicaltrials.gov; unique identifier: NCT01870804).",2020,The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups.,"['709 NSTE-ACS patients randomized to', 'statin-naive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS', 'high-risk coronary patients undergoing angiographic procedures']","['Atorvastatin versus Rosuvastatin', 'atorvastatin', 'rosuvastatin', 'rosuvastatin or atorvastatin', 'atorvastatin and rosuvastatin', 'atorvastatin or rosuvastatin']","['Worsening renal function (WRF', 'rates of AKI, 30-day renal function changes, and 12-month death or MI', '30-day major adverse cardiovascular events, and 12-month myocardial infarction (MI) or death', 'rates of WRF and adverse events', 'AKI (increase in serum creatinine ≥0.5', 'WRF', 'AKI incidence']","[{'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.044536,The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Toso', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy, anna.toso@libero.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Leoncini', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Maioli', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tropeano', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Villani', 'Affiliation': 'Section of Biostatistics and Clinical Epidemiology, Department of Public Health, Neurosciences, Experimental and Forensic Medicine, Pavia University, Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bellandi', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}]",Cardiorenal medicine,['10.1159/000506857']
1073,31521646,The Smoker's Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials.,"OBJECTIVES


This study examined the smoker's paradox using patient-level data from 18 prospective, randomized trials of patients undergoing percutaneous coronary intervention (PCI) with stent implantation.
BACKGROUND


Studies on the effects of smoking and outcomes among patients undergoing PCI have reported conflicting results.
METHODS


Data from the RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS IV and V, ENDEAVOR II to IV, SPIRIT II to IV, HORIZONS-AMI, COMPARE I and II, PLATINUM, and TWENTE I and II randomized trials were pooled. Patients were stratified by smoking status at time of enrollment. The 1- and 5-year ischemic outcomes were compared.
RESULTS


Among 24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers. Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions, more complex lesions, and more occlusions, but were less likely to have moderate or severe calcification or tortuosity. At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization). After multivariable adjustment for potential confounders, smoking was a strong independent predictor of death (hazard ratio [HR]: 1.86; 95% confidence interval [CI]: 1.63 to 2.12; p < 0.0001), cardiac death (HR: 1.68; 95% CI: 1.38 to 2.05; p < 0.0001), MI (HR: 1.38; 95% CI: 1.20 to 1.58; p < 0.0001), stent thrombosis (HR: 1.60; 95% CI: 1.28 to 1.99; p < 0.0001), and target lesion failure (HR: 1.17; 95% CI: 1.05 to 1.30; p = 0.005).
CONCLUSIONS


The present large, patient-level, pooled analysis with 5-year follow-up clearly demonstrates smoking to be an important predictor of adverse outcomes after PCI.",2019,"At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization).","[""Smoker's Paradox Revisited"", 'patients undergoing PCI', '24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers', 'Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting', 'patients undergoing']",['percutaneous coronary intervention (PCI'],"['target lesion failure', 'cardiac death', 'One- and 5-year ischemic outcomes', 'rates of MI', 'stent thrombosis', 'definite or probable stent thrombosis', 'rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3241966'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}]",,0.27658,"At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization).","[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Yadav', 'Affiliation': 'Department of Medicine, Division of Cardiology, Bronx Lebanon Hospital Center, New York, New York.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Canada.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McAndrew', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: gs2184@columbia.edu.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.034']
1074,32440730,Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial.,"PURPOSE


Compared to a healthy population, the gut microbiota in type 2 diabetes presents with several unfavourable features that may impair glucose regulation. The aim of this study was to evaluate the prebiotic effect of inulin-type fructans on the faecal microbiota and short-chain fatty acids (SCFA) in patients with type 2 diabetes.
METHODS


The study was a placebo controlled crossover study, where 25 patients (15 men) aged 41-71 years consumed 16 g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g placebo (maltodextrin) for 6 weeks in randomised order. A 4-week washout separated the 6 weeks treatments. The faecal microbiota was analysed by high-throughput 16S rRNA amplicon sequencing and SCFA in faeces were analysed using vacuum distillation followed by gas chromatography.
RESULTS


Treatment with inulin-type fructans induced moderate changes in the faecal microbiota composition (1.5%, p = 0.045). A bifidogenic effect was most prominent, with highest positive effect on operational taxonomic units (OTUs) of Bifidobacterium adolescentis, followed by OTUs of Bacteroides. Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo. The prebiotic fibre had no effects on the concentration of butyric acid or on the overall microbial diversity.
CONCLUSION


Six weeks supplementation with inulin-type fructans had a significant bifidogenic effect and induced increased concentrations of faecal SCFA, without changing faecal microbial diversity. Our findings suggest a moderate potential of inulin-type fructans to improve gut microbiota composition and to increase microbial fermentation in type 2 diabetes.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov (NCT02569684).",2020,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","['type 2 diabetes', '25 patients (15 men) aged 41-71\xa0years consumed 16\xa0g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g', 'patients with type 2 diabetes']","['placebo (maltodextrin', 'inulin-type fructans', 'placebo']","['faecal concentrations of total SCFA, acetic acid and propionic acid', 'faecal microbiota and short-chain fatty acids (SCFA', 'faecal microbiota and short-chain fatty acids', 'microbial fermentation', 'faecal microbiota', 'faecal microbiota composition', 'concentrations of faecal SCFA']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456636', 'cui_str': '16G'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0995287,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway. eline.birkeland@ous-hf.no.'}, {'ForeName': 'Sedegheh', 'Initials': 'S', 'LastName': 'Gharagozlian', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Måge', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02282-5']
1075,31993783,Measuring the placebo effect in carpal tunnel syndrome.,"BACKGROUND


The placebo effect can account for part of the improvement seen in patients undergoing any type of treatment, be it surgical or pharmacological. The objective of this study is to quantify the placebo effect in carpal tunnel syndrome treatment.
MATERIALS AND METHODS


A double-blinded randomized trial was performed with 68 patients suffering from mild to moderate carpal tunnel syndrome, divided into two groups with no statistically significant differences regarding age, weight, or degree of nerve compression. The patients were evaluated clinically and electromyographically before and after 2 months of treatment with either palmitoylethanolamide (PEA) or placebo.
RESULTS


The results, comparing the two groups, showed an improvement in both groups on a visual analogue scale (VAS) and Levine's questionnaire, which have been reported to show statistical differences in only a few items. In the placebo group, the mean age was 53.32 years (±13.43) and the BMI was 28.85 kg/m 2  (±4.84). Before treatment, the average symptom severity score (SSS) on the Levine questionnaire was 2.57 (±0.74) and the functional status score (FSS) was 2.24 (±0.66). After treatment, these decreased to 2.11 (±0.81) and 1.96 (±0.77), being statistically nonsignificant for SSS (p = 0.0865) but significant for FSS (p = 0.0028). VAS showed a statistically nonsignificant decrease from 4.06 to 3.25 (p = 0.3407). After placebo treatment, SSS, FSS, and VAS improved by 0.46, 0.28, and 0.81 points or 17.89%, 12.5%, and 19.95%, respectively.
CONCLUSIONS


These results show an improvement in the studied parameters by up to 20%, but when compared with those published in literature, these show great variability due to the wide variety of factors involved in the placebo effect. Several factors that affect the placebo effect are discussed, and the present work tries to quantify it in carpal tunnel syndrome.
LEVEL OF EVIDENCE


Level 2 of evidence according to ""The Oxford 2011 Level of Evidence.""",2020,"The results, comparing the two groups, showed an improvement in both groups on a visual analogue scale (VAS) and Levine's questionnaire, which have been reported to show statistical differences in only a few items.","['patients undergoing any type of treatment, be it surgical or pharmacological', '68 patients suffering from mild to moderate carpal tunnel syndrome', 'carpal tunnel syndrome treatment', 'carpal tunnel syndrome']","['placebo', 'VAS', 'palmitoylethanolamide (PEA) or placebo']","['average symptom severity score (SSS) on the Levine questionnaire', 'SSS', 'BMI', 'SSS, FSS, and VAS', 'functional status score (FSS', ""visual analogue scale (VAS) and Levine's questionnaire""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",68.0,0.16147,"The results, comparing the two groups, showed an improvement in both groups on a visual analogue scale (VAS) and Levine's questionnaire, which have been reported to show statistical differences in only a few items.","[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Faig-Martí', 'Affiliation': ""Hospital Sant Rafael, Pg. Vall d'Hebron 107-117, 08035, Barcelona, Catalonia, Spain. 29070jfm@comb.cat.""}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Martínez-Catassús', 'Affiliation': ""Hospital Sant Rafael, Pg. Vall d'Hebron 107-117, 08035, Barcelona, Catalonia, Spain.""}]",Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology,['10.1186/s10195-019-0540-4']
1076,31464558,"Immunogenicity and safety of a dengue vaccine given as a booster in Singapore: a randomized Phase II, placebo-controlled trial evaluating its effects 5-6 years after completion of the primary series.","The tetravalent dengue vaccine (CYD-TDV; Dengvaxia®) is administered on a three-dose schedule, 6 months apart in those aged ≥9 years in a number of dengue-endemic countries in Asia and Latin America. In this study, CYD63 (NCT02824198), participants aged 9-45 years at first vaccination, and who had received three doses of CYD-TDV in the CYD28 study more than 5 years previously, were randomized 3:1 to receive a booster CYD-TDV dose (Group 1) or placebo (Group 2). Dengue neutralizing antibody geometric mean titres (PRNT 50  GMTs) for each of the four dengue serotypes were assessed in sera collected before and 28 days after booster injections. Non-inferiority of the booster immune response versus that induced after the third dose was demonstrated for each serotype if the lower limit of the two-sided 95% confidence interval (CI) was >0.5 for the GMT ratios (GMTRs) between post-booster CYD-TDV dose and post-dose 3 in Group 1. Overall, 118 participants received CYD-TDV booster or placebo and 116 (98.3%) completed the study; two participants were withdrawn because of noncompliance. GMTs in the booster CYD-TDV group increased across all serotypes post-booster injection by 1.74- (serotype 1) to 3.58-fold (serotype 4). No discernible increases were observed in the placebo group. Non-inferiority was demonstrated for serotypes 1, 3, and 4, but not for serotype 2 (GMTR; 0.603 [95% CI, 0.439- 0.829]). No safety issues were observed. These data show that the CYD-TDV booster given 5 or more years later tended to restore GMTs back to levels observed post-dose 3.",2020,"Non-inferiority was demonstrated for serotypes 1, 3 and 4, but not for serotype 2","['118 participants received', 'aged ≥9 years in a number of dengue-endemic countries in Asia and Latin America', 'Singapore', 'participants aged 9-45 years at first vaccination, and who had received three doses of CYD-TDV in the CYD28']","['booster CYD-TDV', 'dengue vaccine', 'CYD-TDV booster or placebo', 'placebo', 'vaccine (CYD-TDV; Dengvaxia®', 'GMTR']",['Immunogenicity and safety'],"[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",118.0,0.498568,"Non-inferiority was demonstrated for serotypes 1, 3 and 4, but not for serotype 2","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Clinical Research and Development, Sanofi Pasteur, Singapore.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'May-Lin Helen', 'Initials': 'MH', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Changi General Hospital, Singapore, Singapore.'}, {'ForeName': 'Lynette Pei-Chi', 'Initials': 'LP', 'LastName': 'Shek', 'Affiliation': 'Department of Pediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Biostatistics, Sanofi, Beijing, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bonaparte', 'Affiliation': 'Global Clinical Immunology department, Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Fargo', 'Affiliation': 'Clinical Research and Development, Sanofi Pasteur, Singapore.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bouckenooghe', 'Affiliation': 'Clinical Research and Development, Sanofi Pasteur, Singapore.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1661204']
1077,31451351,Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis.,"BACKGROUND


Shortcomings of inhaled antibiotic treatments for Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) include poor drug penetration, inactivation by sputum, poor efficiency due to protective biofilm, and short residence in the lung.
METHODS


Eligible patients with forced expiratory volume in 1 s (FEV 1 ) ≥25% of predicted value at screening and CF with chronic P. aeruginosa infection were randomly assigned to receive 3 treatment cycles (28 days on, 28 days off) of amikacin liposome inhalation suspension (ALIS, 590 mg QD) or tobramycin inhalation solution (TIS, 300 mg BID). The primary endpoint was noninferiority of ALIS vs TIS in change from baseline to day 168 in FEV 1  (per-protocol population). Secondary endpoints included change in respiratory symptoms by Cystic Fibrosis Questionnaire-Revised (CFQ-R).
RESULTS


The study was conducted February 2012 to September 2013. ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV 1  (L) from baseline. The mean increases in CFQ-R score from baseline on the Respiratory Symptoms scale suggested clinically meaningful improvement in both arms at the end of treatment in cycle 1 and in the ALIS arm at the end of treatment in cycles 2 and 3; however, the changes were not statistically significant between the 2 treatment arms. Treatment-emergent adverse events (TEAEs) were reported in most patients (ALIS, 84.5%; TIS, 78.8%). Serious TEAEs occurred in 17.6% and 19.9% of patients, respectively; most were hospitalisations for infective pulmonary exacerbation of CF.
CONCLUSIONS


Cyclical dosing of once-daily ALIS was noninferior to cyclical twice-daily TIS in improving lung function. ClinicalTrials.gov Identifier: NCT01315678.",2020,"ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV 1  (L) from baseline.","['February 2012 to September 2013', 'chronic Pseudomonas aeruginosa infection in cystic fibrosis', 'Eligible patients with forced expiratory volume in 1\u202fs (FEV 1 ) ≥25% of predicted value at screening and CF with chronic P. aeruginosa infection', 'patients with cystic fibrosis (CF']","['Amikacin liposome inhalation suspension', 'inhaled antibiotic treatments', 'amikacin liposome inhalation suspension (ALIS, 590\u202fmg QD) or tobramycin inhalation solution (TIS, 300\u202fmg BID']","['change in respiratory symptoms by Cystic Fibrosis Questionnaire-Revised (CFQ-R', 'noninferiority of ALIS vs TIS', 'Serious TEAEs', 'lung function', 'CFQ-R score']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1154181', 'cui_str': 'Inhalation Solution'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.117115,"ALIS was noninferior to TIS (95% CI, -4.95 to 2.34) for relative change in FEV 1  (L) from baseline.","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bilton', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Tacjana', 'Initials': 'T', 'LastName': 'Pressler', 'Affiliation': 'Rigshospitalet (Hospital), Copenhagen, Denmark.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fajac', 'Affiliation': 'AP-HP, Université Paris Descartes, Paris, France.'}, {'ForeName': 'John Paul', 'Initials': 'JP', 'LastName': 'Clancy', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Sands', 'Affiliation': 'Cystic Fibrosis Department, Institute of Mother and Child, Warsaw, Poland.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Minic', 'Affiliation': 'Institute for Mother and Child Health Care, Department of Pulmonology, Medical School University of Belgrade, Serbia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cipolli', 'Affiliation': 'Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Galeva', 'Affiliation': 'Pediatric Clinic, Infants Department, Alexandrovska University Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Solé', 'Affiliation': 'Lung Transplant and Cystic Fibrosis Unit, Hospital Universitari i Politecnic La Fe, Valencia, Spain.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Quittner', 'Affiliation': 'University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McGinnis', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Eagle', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Insmed Incorporated, Bridgewater, NJ, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Konstan', 'Affiliation': ""Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, OH, USA. Electronic address: Michael.Konstan@case.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.08.001']
1078,31460693,"Incidence, predictors, and outcomes of distal vessel expansion on follow-up intravascular ultrasound after recanalization of chronic total occlusions using new-generation drug-eluting stents: Data from the CTO-IVUS randomized trial.","OBJECTIVES


To evaluate the incidence, predictors, and outcomes of distal vessel expansion on intravascular ultrasound (IVUS) after recanalization of chronic total occlusion (CTO) particularly using new-generation drug-eluting stent (DES).
BACKGROUND


The luminal changes of narrowed vessels distal to CTO segments after recanalization using new-generation DES have rarely been studied.
METHODS


This substudy of the CTO-IVUS (Chronic Total Occlusion InterVention with drUg-eluting Stents) trial included a total of 69 new-generation DES-treated CTOs with serial matched IVUS analyses at index percutaneous coronary intervention (PCI) and at 1-year follow-up. The predictors of distal vessel expansion, any increase of lumen area at the distal reference (LA distal  ) on 1-year follow-up IVUS, were evaluated by multivariable binary logistic analyses.
RESULTS


Distal vessel expansion was identified in 46 (67%). Independent determinants of distal vessel expansion were proximal CTO, a smaller LA distal  at the index PCI, a greater minimal stent area-to-LA distal  (MSA-to-LA distal  ) ratio, and a greater lumen area at the distal stent edge-to-LA distal  (LA edge  -to-LA distal  ) ratio. The cut-off values of a MSA-to-LA distal  ratio and a LA edge  -to-LA distal  ratio predicting the distal vessel expansion by receiver operating characteristic curve analysis were 1.0 and 1.1, respectively. During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups.
CONCLUSION


After opening CTO with new-generation DES, two-thirds of patients exhibited distal vessel expansion on 1-year follow-up IVUS. Expansion determinants were a proximal CTO, lower LA distal  , and larger stent areas relative to the LA distal  (modifiable procedural predictors).",2020,"During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups.
",['trial included a total of 69 new-generation DES-treated CTOs with serial matched IVUS analyses at index percutaneous coronary intervention (PCI) and at 1-year follow-up'],"['intravascular ultrasound (IVUS', 'CTO-IVUS (Chronic Total Occlusion InterVention with drUg-eluting Stents']","['exhibited distal vessel expansion', 'distal vessel expansion', 'Distal vessel expansion', 'rates of target vessel revascularization, cardiac death, and stent thrombosis']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}]","[{'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.0320893,"During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups.
","[{'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Joo', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Seung-Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, South Korea.'}, {'ForeName': 'Hee-Yeol', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': ""Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, South Korea.""}, {'ForeName': 'Jin-Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Doonghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28461']
1079,32441302,Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial.,"Ultrasound-guided costoclavicular block (CC-approach) is a recently described brachial plexus block (BPB) and an alternative approach to the supraclavicular approach (SC-approach). The relevant sonoanatomy is analogous in terms of the brachial plexus and its adjacent artery for both approaches. In the present study, we hypothesized that the two approaches will result in similar block dynamics when used the modified double-injection (MDI) technique. One hundred and twelve patients were randomly allocated to receive either a SC- or CC-approach with MDI technique. In the CC group, half the volume was injected adjacent to the medial cord of the brachial plexus, the procedure was guided by ultrasound and verified by nerve stimulator, subsequently the second half was injected close to the lateral cord. In the SC group, the MDI technique was carried out as described in our previous study. Sensory and motor blockade of all four terminal nerves were assessed with a 3-point scale. The primary outcome was the proportion of complete sensory blockade at 15 min with a predefined non-inferiority margin of -13%. The proportion of subjects at 15 min was comparable between the SC group and the CC group (91 vs 87%, absolute difference: -3%). No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05). We conclude that the MDI technique applied to a costoclavicular and supraclavicular block resulted in similar block dynamics. In addition, it may provide a promising alternative technique when considering the use of multipoint injection.",2020,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).",['112 patients'],"['SC- or CC-approach with MDI technique', 'ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique', 'Ultrasound-guided costoclavicular block (CC-approach']","['proportion of complete sensory blockade', 'complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",112.0,0.0308918,"No significant differences were found for complete motor blockade and onset times of the individual nerves within 30 min, and block-related serious adverse events (all P>0.05).","[{'ForeName': 'Quehua', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': ""Department of Anesthesiology, Cardiovascular Institute of Guangdong Province, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'HaiHua', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': 'The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.'}]",Bioscience reports,['10.1042/BSR20200084']
1080,32441473,Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.,"OBJECTIVE


The obesity epidemic is a public health concern, warranting further research into pharmacological treatments for weight management (WM) as an adjunct to lifestyle interventions. The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
METHODS


Across five phase 3 trials (NCT03548935, WM; NCT03552757, WM in type 2 diabetes; NCT03611582, WM with intensive behavioral therapy; NCT03548987, sustained WM; and NCT03693430, long-term WM), ~5,000 participants are being randomly assigned to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results will be available in 2020/2021. For all trials, the primary end point is change from baseline to end of treatment in body weight.
RESULTS


Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2  and a mean waist circumference of 113.0 to 115.7 cm.
CONCLUSIONS


The STEP program evaluates the efficacy and safety of semaglutide 2.4 mg subcutaneously once weekly in a broad population. The trials will provide insights on WM in people with obesity with and without type 2 diabetes and on long-term follow-up.",2020,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
","['Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2  and a mean waist circumference of 113.0 to 115.7 cm', '5,000 participants', 'people with obesity with and without type 2 diabetes and on long-term follow-up', 'adults with obesity or overweight', 'People with obesity (STEP) program']","['semaglutide 2.4 mg once weekly subcutaneously versus placebo', 'semaglutide versus placebo']","['body weight', 'efficacy and safety', 'weight loss, safety, and tolerability']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0600766,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight.
","[{'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Division of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Calanna', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Department of Internal Medicine, Hasharon Hospital Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology, UT Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Wharton', 'Affiliation': 'York University and Wharton Weight Management Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22794']
1081,31394155,Stratifying comatose postanoxic patients for somatosensory evoked potentials using routine EEG.,"INTRODUCTION


Multimodal neurological prognostication is recommended for comatose patients after cardiac arrest. The absence of cortical N20-potentials in a somatosensory evoked potential (SSEP) examination reliably predicts poor outcome, but presence of N20-potentials have limited prognostic value. A benign routine electroencephalogram (EEG) may identify patients with a favourable prognosis who are likely to have present N20-potentials.
OBJECTIVE


To investigate whether a routine EEG can identify patients where SSEP is unnecessary to perform.
METHODS


In a multi-centre trial, comatose patients after cardiac arrest were randomised to a controlled temperature of 33 °C or 36 °C. A routine EEG was protocolised and SSEP performed at the clinicians' discretion, both during normothermic conditions. EEGs were categorised into benign, malignant or highly malignant based on standardised terminology. A benign EEG was defined as a continuous normal-voltage background without abundant discharges. The N20-potentials were reported as absent (bilaterally) or present (bilaterally or unilaterally).
RESULTS


Both EEG and SSEP were performed in 161 patients. EEG was performed before SSEP in 60%. A benign EEG was seen in 29 patients and 100% (CI 88-100%) had present N20-potentials. For the 69 patients with a malignant EEG and the 63 patients with a highly malignant EEG, 67% (CI 55-77%) and 44% (CI 33-57%) had present N20-potentials, respectively.
CONCLUSIONS


All patients with a benign EEG had present N20-potentials, suggesting that SSEP may be omitted in these patients to save resources. SSEP is useful in patients with a malignant or highly malignant EEG since these patterns are associated with both present and absent N20-potentials.",2019,"All patients with a benign EEG had present N20-potentials, suggesting that SSEP may be omitted in these patients to save resources.","['patients with a malignant or highly malignant EEG', '69 patients with a malignant EEG and the 63 patients with a highly malignant EEG', 'patients with a favourable prognosis who are likely to have present N20-potentials', 'comatose patients after cardiac arrest', '161 patients']","['routine EEG', 'SSEP']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]",[],161.0,0.0279929,"All patients with a benign EEG had present N20-potentials, suggesting that SSEP may be omitted in these patients to save resources.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fredland', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Clinical Neurophysiology, Lund, Sweden. Electronic address: anna.fredland.607@student.lu.se.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Backman', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Clinical Neurophysiology, Lund, Sweden. Electronic address: sofia.backman@med.lu.se.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Westhall', 'Affiliation': 'Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Clinical Neurophysiology, Lund, Sweden. Electronic address: erik.westhall@med.lu.se.'}]",Resuscitation,['10.1016/j.resuscitation.2019.07.027']
1082,31453915,Transcranial Magnetic Stimulation in Adults With Amblyopia.,"BACKGROUND


Through transcranial magnetic stimulation (TMS) it is possible to change cortical excitability of the visual cortex, and to influence binocular balance. The main goal of our study is to assess the effect of transcranial magnetic stimulation, specifically theta burst stimulation (TBS), in a group of amblyopic volunteers measuring several visual parameters: visual acuity, suppressive imbalance, and stereoacuity.
METHODS


Thirteen volunteers aged 19 to 24 years, randomly split in 2 groups, underwent 1 session of continuous TBS, stimulating the right occipital lobe. The first group with 8 volunteers was exposed to active stimulation with cTBS, and the other group with 5 volunteers was exposed to placebo stimulation.
RESULTS


Significant improvements in visual acuity, suppressive imbalance, and stereoacuity were found in the amblyopic eye after cTBS. The average value of amblyopia in visual acuity before stimulation was 0.32 ± 0.20 logMar and after cTBS was 0.19 ± 0.17 logMar. The mean value for the control group before placebo stimulation was 0.28 ± 0.17 and after placebo stimulation was 0.28 ± 0.16. The suppressive imbalance in the group of amblyope subjects stimulated before cTBS was 0.26 ± 0.18 and after was 0.12 ± 0.12; the suppressive imbalance of the control group before the placebo stimulation was 0.34 ± 0.37 and after was 0.32 ± 0.40.
CONCLUSIONS


Visual acuity, suppressive imbalance, and stereoacuity had significant enhancements compared with baseline after cTBS over the right occipital lobe in an ambliopic population.",2020,The mean value for the control group before placebo stimulation was 0.28 ± 0.17 and after placebo stimulation was 0.28 ± 0.16.,"['Adults With Amblyopia', 'Thirteen volunteers aged 19 to 24 years']","['placebo stimulation', 'Transcranial Magnetic Stimulation', 'transcranial magnetic stimulation, specifically theta burst stimulation (TBS', 'transcranial magnetic stimulation (TMS']","['average value of amblyopia in visual acuity', 'mean value', 'several visual parameters: visual acuity, suppressive imbalance, and stereoacuity', 'visual acuity, suppressive imbalance, and stereoacuity', 'suppressive imbalance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}]",13.0,0.100827,The mean value for the control group before placebo stimulation was 0.28 ± 0.17 and after placebo stimulation was 0.28 ± 0.16.,"[{'ForeName': 'Ana Rita', 'Initials': 'AR', 'LastName': 'Tuna', 'Affiliation': 'CICS-Health Sciences Research Centre (ART, NP, FMB, AF, AFN, MVP), Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal; Dr. Lopes Dias School of Health (NP), Polytechnic Institute of Castelo Branco, Castelo Branco, Portugal; Department of Physics (FMB, AFN), University of Beira Interior, Covilhã, Portugal; and CICS-Health Sciences Research Centre (MVP), Faculty of Health Sciences, University of Beira Interior; ULS Guarda, Guarda, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Pinto', 'Affiliation': ''}, {'ForeName': 'Francisco Miguel', 'Initials': 'FM', 'LastName': 'Brardo', 'Affiliation': ''}, {'ForeName': 'Andresa', 'Initials': 'A', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Amélia Fernandes', 'Initials': 'AF', 'LastName': 'Nunes', 'Affiliation': ''}, {'ForeName': 'Maria Vaz', 'Initials': 'MV', 'LastName': 'Pato', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000828']
1083,31434028,"Effects of non-tobacco flavors and nicotine on e-cigarette product appeal among young adult never, former, and current smokers.","BACKGROUND


E-cigarette regulations targeting products that disproportionately appeal to never-smokers may optimize population health. This laboratory study of young adults tested whether differences in appeal between e-cigarettes with non-tobacco-flavored (vs. tobacco-flavored) and nicotine-containing (vs. nicotine-free) solutions varied by smoking history.
METHODS


Current (N = 53), former (N = 25), and never (N = 22) cigarette smokers who vape (Mean[SD] age = 25.4[4.4] years) administered standardized e-cigarette doses varied by a Flavor (fruit, menthol, tobacco) × Nicotine (nicotine-containing [6 mg/mL], nicotine-free) within-subject double-blind design. Participants rated each dose's appeal (0-100 scale). Covariate-adjusted interactions tested whether smoking history moderated flavor and nicotine effects.
RESULTS


Appeal was higher for fruit and menthol than tobacco flavors in each group. The fruit vs. tobacco appeal difference was greater in never smokers (fruit-tobacco estimate = 19.6) than current smokers (estimate = 12.1) but not former smokers (estimate = 12.6). The menthol vs. tobacco difference was greater in never smokers (menthol-tobacco estimate = 17.3) than former (estimate = 6.0) and current (estimate = 7.2) smokers. Appeal was lower for nicotine-containing than nicotine-free solutions in each group; this difference was greater in never smokers (nicotine-nicotine-free estimate = -17.3) than former (estimate = -7.0) and current (estimate = -10.6) smokers. Compared to tobacco flavors, nicotine's appeal-reducing effects were suppressed by fruit and menthol flavors in never smokers.
CONCLUSIONS


Higher appeal of non-tobacco-flavored (vs. tobacco-flavored) and lower appeal of nicotine-containing (vs. nicotine-free) e-cigarettes may be widespread in young adults but disproportionately amplified in never smokers. Non-tobacco flavors may suppress nicotine's appeal-lowering qualities in never smokers. The impact of regulating non-tobacco flavors in e-cigarettes may vary by smoking history.",2019,Appeal was lower for nicotine-containing than nicotine-free solutions in each group; this difference was greater in never smokers (nicotine-nicotine-free estimate = -17.3) than former (estimate = -7.0) and current (estimate = -10.6) smokers.,"['young adults tested whether differences in appeal between e-cigarettes with non-tobacco-flavored (vs. tobacco-flavored) and', 'young adults', 'young adult never, former, and current smokers', 'Current (N\u202f=\u202f53), former (N\u202f=\u202f25), and never (N\u202f=\u202f22) cigarette smokers who vape (Mean[SD] age\u202f=\u202f25.4[4.4] years) administered']","['standardized e-cigarette doses varied by a Flavor (fruit, menthol, tobacco) × Nicotine (nicotine-containing [6\u202fmg/mL], nicotine-free', 'non-tobacco flavors and nicotine', 'nicotine-containing (vs. nicotine-free) e-cigarettes', 'nicotine-containing (vs. nicotine-free) solutions']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C3241966'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]",[],,0.0349391,Appeal was lower for nicotine-containing than nicotine-free solutions in each group; this difference was greater in never smokers (nicotine-nicotine-free estimate = -17.3) than former (estimate = -7.0) and current (estimate = -10.6) smokers.,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA; Department of Psychology, University of Southern California, Los Angeles, CA, USA. Electronic address: adam.leventhal@usc.edu.'}, {'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barrington-Trimis', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.05.020']
1084,31453920,A Reliability and Comparative Analysis of the New Randomized King-Devick Test.,"OBJECTIVE


The King-Devick (K-D) test is a rapid visual screening tool that can assess underlying brain trauma such as concussion via impairments in saccadic rhythm. A new tablet version of the K-D test using randomized numbers is now available, but reliability for this new version and comparison to the traditional K-D test has not yet been reported. Known for learning effects in the test, the aim of this study was to determine test-retest reliability and to compare performance of the new ""randomized"" version to the ""traditional"" K-D test version. We hypothesized that the ""traditional"" K-D test would show a greater rate of improvement with repeat application, compared with the ""randomized"" K-D test.
METHODS


Using a cross-sectional, repeated measures design in a healthy university student cohort (n = 96; age 21.6 ± 2.8 years; 49 women, 47 men), participants were required to complete the K-D test twice with a one-week break between testing sessions. Participants were randomly assigned into a ""traditional"" group, where they completed a test-retest of the established K-D protocol, using the same numbers; or the ""randomized"" group, where they completed test-retest protocol using 2 different sets of numbers.
RESULTS


Reliability testing showed a strong intraclass correlation coefficient for both the ""traditional"" test group (control group; 0.95 [CI: 0.91-0.97]) and the ""randomized test group"" (0.97 [CI: 0.95-0.98]). However, contrary to our hypothesis, no differences were found between ""traditional"" and ""randomized"" groups for baseline (control: 42.5 seconds [CI: 40.2-44.9 s] vs randomized: 41.5 [38.7-44.4], P = 0.23) and repeated testing between groups (control: 40.0 seconds [37.9-42.1 s] vs randomized: 39.5 [36.9-42.0], P = 0.55), with both groups showing improved times with repeated testing (control: 2.1 seconds [CI: 1.1-3.2 seconds] and randomized: 1.9 seconds CI: [0.9-2.9 seconds], P < 0.001).
CONCLUSIONS


The ""randomized"" version of the K-D test, using different sets of numbers, demonstrates good reliability that is comparable to the traditional K-D testing protocol that uses the same number sets. However, similar to the ""traditional"" K-D test, learning effects were also observed in the ""randomized"" test, suggesting that learning effects are not because of content memorization, but rather familiarity of the test. As a result, although either test format is suitable for sideline concussion screening or return to play decisions, comparison of data should be made to the individual's baseline rather than to normative data sets.",2020,"RESULTS


Reliability testing showed a strong intraclass correlation coefficient for both the ""traditional"" test group (control group; 0.95 [CI: 0.91-0.97]) and the ""randomized test group"" (0.97 [CI: 0.95-0.98]).","['healthy university student cohort (n = 96; age 21.6 ± 2.8 years; 49 women, 47 men']",[],[],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],[],49.0,0.0905727,"RESULTS


Reliability testing showed a strong intraclass correlation coefficient for both the ""traditional"" test group (control group; 0.95 [CI: 0.91-0.97]) and the ""randomized test group"" (0.97 [CI: 0.95-0.98]).","[{'ForeName': 'Minh Q', 'Initials': 'MQ', 'LastName': 'Nguyen', 'Affiliation': 'School of Allied Health (MQN, AJP), Human Services and Sport, La Trobe University, Melbourne, Australia; and Sports Performance Research Institute New Zealand (SPRINZ) (DK), Faculty of Health and Environmental Science, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Pearce', 'Affiliation': ''}]",Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000000829']
1085,32438071,Baseline urinary metabolites predict albuminuria response to spironolactone in type 2 diabetes.,"The mineralocorticoid receptor antagonist spironolactone significantly reduces albuminuria in subjects with diabetic kidney disease, albeit with a large variability between individuals. Identifying novel biomarkers that predict response to therapy may help to tailor spironolactone therapy. We aimed to identify a set of metabolites for prediction of albuminuria response to spironolactone in subjects with type 2 diabetes. Systems biology molecular process analysis was performed a priori to identify metabolites linked to molecular disease processes and drug mechanism of action. Individual subject data and urine samples were used from 2 randomized placebo controlled double blind clinical trials (NCT01062763, NCT00381134). A urinary metabolite score was developed to predict albuminuria response to spironolactone therapy using penalized ridge regression with leave-one-out cross validation. Bioinformatic analysis identified a set of 18 metabolites linked to a diabetic kidney disease molecular model and potentially affected by spironolactone mechanism of action. Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively. In the test cohort, UACR reduction was higher in the lowest tertile of the baseline urinary metabolite score compared with middle and upper tertiles -58% (25th to 75% percentile -78 to 33), -28% (25th to 75% percentile -46 to 8), -40% (25th to 75% percentile -52% to 31), respectively, P = 0.001 for trend). In the replication cohort, UACR reduction was -54% (25th to 75% percentile -65 to -50), -41 (25th to 75% percentile -46% to 30), and -17% (25th to 75% percentile -36 to 5), respectively, P = 0.010 for trend). We identified a set of 18 urinary metabolites through systems biology to predict albuminuria response to spironolactone in type 2 diabetes. These data suggest that urinary metabolites may be used as a tool to tailor optimal therapy and move in the direction of personalized medicine.",2020,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","['subjects with diabetic kidney disease', 'type 2 diabetes', 'subjects with type 2 diabetes']","['spironolactone', 'mineralocorticoid receptor antagonist spironolactone', 'Spironolactone', 'spironolactone therapy', 'placebo']","['baseline urinary metabolite score', 'UACR reduction', 'albuminuria response', 'UACR relative']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0356557,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perco', 'Affiliation': 'Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Oxlund', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Uzma F', 'Initials': 'UF', 'LastName': 'Mehdi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hankemeier', 'Affiliation': 'Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Ib A', 'Initials': 'IA', 'LastName': 'Jacobsen', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: m.pena@umcg.nl.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.04.010']
1086,31444050,"Endocrine characteristics, body mass index and metabolic syndrome in women with polycystic ovary syndrome.","RESEARCH QUESTION


The study aimed to evaluate the associations of endocrine and ultrasound characteristics with metabolic syndrome in women with polycystic ovary syndrome (PCOS), and whether these associations were modified by body mass index (BMI).
DESIGN


The study was a secondary analysis of baseline data from a randomized controlled trial of induction of ovulation in women with PCOS.
RESULTS


Among 947 Chinese women with PCOS, 153 (16.2%) were diagnosed with metabolic syndrome. The prevalence of metabolic syndrome in women with normal (<24 kg/m 2 ) and high (≥24 kg/m 2 ) BMI was 3.6% and 30.5%, respectively. In all women, a high free androgen index (FAI ≥5%) was positively associated with metabolic syndrome (adjusted odds ratio [OR] 2.06, 95% confidence interval [CI] 1.11-3.82). High FAI was positively associated with metabolic syndrome among women with high BMI (adjusted OR 3.37, 95% CI 1.78-6.37), but the association was not significant in women with normal BMI (adjusted OR 1.27, 95% CI 0.34-4.70). The presence of polycystic ovary morphology was negatively associated with metabolic syndrome (adjusted OR 0.52, 95% CI 0.26-1.03) in all women (normal BMI adjusted OR 0.42, 95% CI 0.11-1.67; high BMI adjusted OR 0.54, 95% CI 0.23-1.28). LH, sex hormone-binding globulin (SHBG) and anti-Müllerian hormone (AMH) were negatively associated with metabolic syndrome. The associations of FAI, SHBG and AMH in relation to metabolic syndrome were significantly modified by BMI.
CONCLUSION(S)


The associations of endocrine characteristic with metabolic syndrome were modified by BMI in women with PCOS. Women with PCOS and normal BMI did not have an increased risk of metabolic syndrome.",2019,"The presence of polycystic ovary morphology was negatively associated with metabolic syndrome (adjusted OR 0.52, 95% CI 0.26-1.03) in all women (normal BMI adjusted OR 0.42, 95% CI 0.11-1.67; high BMI adjusted OR 0.54, 95% CI 0.23-1.28).","['women with polycystic ovary syndrome (PCOS', 'women with polycystic ovary syndrome', 'women with normal (<24\xa0kg/m 2 ) and high (≥24\xa0kg/m 2 ', 'women with PCOS', '947 Chinese women with PCOS, 153 (16.2%) were diagnosed with metabolic syndrome']",[],"['metabolic syndrome', 'risk of metabolic syndrome', 'Endocrine characteristics, body mass index and metabolic syndrome', 'BMI', 'high free androgen index', 'FAI, SHBG and AMH in relation to metabolic syndrome', 'presence of polycystic ovary morphology', 'normal BMI', 'LH, sex hormone-binding globulin (SHBG) and anti-Müllerian hormone (AMH']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]",[],"[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]",947.0,0.194201,"The presence of polycystic ovary morphology was negatively associated with metabolic syndrome (adjusted OR 0.52, 95% CI 0.26-1.03) in all women (normal BMI adjusted OR 0.42, 95% CI 0.11-1.67; high BMI adjusted OR 0.54, 95% CI 0.23-1.28).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong; Reproduction and Development Laboratory, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong; School of Biomedical Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Robinson Research Institute and Adelaide Medical School, University of Adelaide, North Adelaide, Australia.'}, {'ForeName': 'Ernest H Y', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Liu', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton Victoria, Australia.'}, {'ForeName': 'Xiao-Ke', 'Initials': 'XK', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.06.014']
1087,31434537,Effectiveness of Lower-Extremity Functional Training (LIFT) in Young Children With Unilateral Spastic Cerebral Palsy: A Randomized Controlled Trial.,"Background . Children with unilateral spastic cerebral palsy (USCP) have strength, coordination, and balance deficits affecting gross motor skills, such as walking, running, and jumping. However, there is a paucity of evidence for effective treatments for lower-extremity (LE) function in children with USCP.  Objective . To determine the effectiveness of LE intensive functional training (LIFT) compared with an attention control group receiving upper-extremity bimanual training (Hand-Arm Bimanual Intensive Therapy [H-HABIT]).  Methods . A total of 24 children with USCP were randomized to receive 90 hours of LIFT (5.8 [2.3] years) or an equivalent dosage of H-HABIT (5.1 [2.6] years) delivered 2 h/d, 5 d/wk for 9 weeks. Caregivers were trained to administer the intervention in the home setting. Progress and skill progression were monitored, and supervision was provided via weekly telerehabilitation. The primary outcome was the 1-minute walk test (1MWT). Secondary outcomes included self-selected and fast walking speeds, ABILOCO-kids, 30-s chair rise test, and single-leg stance.  Results . LIFT showed greater improvement for the 1MWT ( P  = .017) and ABILOCO-kids ( P  = .008) compared with controls. The other secondary outcomes were not different between groups.  Conclusions . The administration of LE intensive interventions in the home setting by caregivers was shown to be an effective and novel mode of delivery for improving gait capacity and performance. LIFT delivered in the home setting using telerehabilitation for monitoring resulted in improvements in ambulation distance and overall walking ability as compared to an intervention of equal intensity and duration that also controlled for the increased social interaction and attention between caregiver and child.",2019,LIFT showed greater improvement for the 1MWT ( P  = .017) and ABILOCO-kids ( P  = .008) compared with controls.,"['Young Children With Unilateral Spastic Cerebral Palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', '24 children with USCP']","['attention control group receiving upper-extremity bimanual training (Hand-Arm Bimanual Intensive Therapy [H-HABIT', 'LE intensive functional training (LIFT', 'Lower-Extremity Functional Training (LIFT', 'LE intensive interventions']","['ambulation distance and overall walking ability', '1-minute walk test (1MWT', 'self-selected and fast walking speeds, ABILOCO-kids, 30-s chair rise test, and single-leg stance', '1MWT']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.11282,LIFT showed greater improvement for the 1MWT ( P  = .017) and ABILOCO-kids ( P  = .008) compared with controls.,"[{'ForeName': 'Bhavini K', 'Initials': 'BK', 'LastName': 'Surana', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Claudio L', 'Initials': 'CL', 'LastName': 'Ferre', 'Affiliation': 'Burke Neurological Institute, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Dew', 'Affiliation': 'Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Brandao', 'Affiliation': 'Department of Occupational Therapy and Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Noelle G', 'Initials': 'NG', 'LastName': 'Moreau', 'Affiliation': 'LSU Health Sciences Center, New Orleans, LA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968319868719']
1088,32441691,Wellness Coaching: An Intervention to Increase Healthy Behavior in Breast Cancer Survivors.,"BACKGROUND


Regular physical activity after breast cancer diagnosis improves survival rates and quality of life (QOL). However, breast cancer survivors rarely meet guidelines for recommended levels of physical activity. Wellness coaching interventions (WCIs) have improved exercise and health behaviors in other patient populations.
OBJECTIVES


This study assessed the feasibility and effectiveness of WCIs for increasing physical activity in breast cancer survivors; secondary measures included changes in dietary habits, weight, and QOL.
METHODS


20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment were recruited into a single-arm, 12-week WCI pilot feasibility study. The intervention was comprised of one in-person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations.
FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL. Forty percent of participants achieved the 3% postintervention weight-loss goal, but this was not sustained at 30 weeks.",2020,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","['Breast Cancer Survivors', 'breast cancer survivors', '20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment']","['WCIs', 'Wellness coaching interventions (WCIs', 'person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations', 'Wellness Coaching']","['dietary habits, weight, and QOL', 'physical activity level, dietary habits', 'survival rates and quality of life (QOL']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0242179,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","[{'ForeName': 'Daniela L', 'Initials': 'DL', 'LastName': 'Stan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Cutshall', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Tammy F', 'Initials': 'TF', 'LastName': 'Adams', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ghosh', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kaisa C', 'Initials': 'KC', 'LastName': 'Wieneke', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Esayas B', 'Initials': 'EB', 'LastName': 'Kebede', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Donelan Dunlap', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Hazelton', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Alissa M', 'Initials': 'AM', 'LastName': 'Butts', 'Affiliation': 'Medical College of Wisconsin.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jenkins', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Bauer', 'Affiliation': 'Mayo Clinic.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.305-315']
1089,31420627,[Breastfeeding promotion strategies study on preterm infants in the neonatal intensive care unit].,"OBJECTIVE


To explore the effect of breastfeeding promotion strategies on neonatal clinical outcomes of preterm infants during hospitalization in the neonatal intensive care unit (NICU).
METHODS


We developed breastfeeding promotion strategies, including the establishment of a multidisciplinary breastfeeding steering team, breastfeeding support of families and society, family-integrated care, kangaroo mother care, donor human milk bank, and so on. Preterm infants meeting the inclusion standard, less than 32 weeks gestational age, who were admitted to NICU from November 2015 to February 2017 were enrolled, and the eligible infants were divided into two groups (control group and intervention group) before and after policy implementation. The data of preterm infants including breastfeeding related outcomes (time to initiation of enteral feeding, time to initiation of breastfeeding, time to achieve full breastfeeding, time to achieve full enteral feeding and rate of breastfeeding), growth (extrauterine growth restriction) and complications were compared between the two groups.
RESULTS


One hundred and twenty-three preterm infants were enrolled, including 61 in the control group and 62 in the intervention group. There were no significant differences in gender, gestational age, birth weight, intrauterine growth retardation (IUGR) and admission disease status between the two groups (P>0.05). Compared with the control group, there were significantly earlier time to initiation of enteral feeding [15.37 (10.00, 22.13) h vs. 20.25 (12.88, 26.33) h, P<0.01], time to achieve full breastfeeding [91.00 (69.75, 103.00) h vs. 94.00 (80.37, 118.75) h, P=0.04], and time to achieve full enteral feeding [12 (11, 15) d vs. 14 (12, 18) d, P<0.01] in the intervention group. Otherwise, there were no significant differences in time to initiation of breastfeeding, hospital stay, extrauterine growth restriction (EUGR) occurance rate of weight, the rate of breastfeeding, motality, and the incidence of complications including feeding intolerance, neonatal necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP) (P>0.05).
CONCLUSION


The breastfeeding promotion strategie was a quality improvement of ordinary breastfeeding protocol. It had significantly reduced time to initiation of enteral feeding, time to achieve full breastfeeding and time to achieve full enteral feeding for preterm infants in NICU. Further research is needed to confirm whether the strategies can improve the breastfeeding rate and reduce the occurrence of the complications, such as NEC, BPD, and ROP.",2019,"There were no significant differences in gender, gestational age, birth weight, intrauterine growth retardation (IUGR) and admission disease status between the two groups (P>0.05).","['preterm infants in the neonatal intensive care unit', 'preterm infants during hospitalization in the neonatal intensive care unit (NICU', 'Preterm infants meeting the inclusion standard, less than 32 weeks gestational age, who were admitted to NICU from November 2015 to February 2017 were enrolled, and the eligible infants', 'One hundred and twenty-three preterm infants were enrolled, including 61 in the control group and 62 in the intervention group']",['breastfeeding promotion strategies'],"['time to achieve full breastfeeding', 'time to achieve full enteral feeding', 'breastfeeding related outcomes (time to initiation of enteral feeding, time to initiation of breastfeeding, time to achieve full breastfeeding, time to achieve full enteral feeding and rate of breastfeeding), growth (extrauterine growth restriction) and complications', 'gender, gestational age, birth weight, intrauterine growth retardation (IUGR) and admission disease status', 'time to initiation of enteral feeding, time to achieve full breastfeeding and time to achieve full enteral feeding', 'earlier time to initiation of enteral feeding', 'time to initiation of breastfeeding, hospital stay, extrauterine growth restriction (EUGR) occurance rate of weight, the rate of breastfeeding, motality, and the incidence of complications including feeding intolerance, neonatal necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP) (P>0.05']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C2317036', 'cui_str': 'Initiation of breastfeeding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}]",2017.0,0.0256955,"There were no significant differences in gender, gestational age, birth weight, intrauterine growth retardation (IUGR) and admission disease status between the two groups (P>0.05).","[{'ForeName': 'X L', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'Department of Neonatology, Chongqing Health Center for Women and Children, Chongqing 401147, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Neonatology, Chongqing Health Center for Women and Children, Chongqing 401147, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Zhong', 'Affiliation': 'Department of Neonatology, Chongqing Health Center for Women and Children, Chongqing 401147, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Neonatology, Chongqing Health Center for Women and Children, Chongqing 401147, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Neonatology, Chongqing Health Center for Women and Children, Chongqing 401147, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,['10.19723/j.issn.1671-167X.2019.04.020']
1090,31420633,[Effects of thoracic epidural administration of lidocaine on hemodynamic and arousal responses of double lumen tracheal intubation during induction of anesthesia].,"OBJECTIVE


To compare the effects of thoracic epidural administration of lidocaine on hemodynamic and arousal responses of double lumen tracheal intubation during induction of anesthesia.
METHODS


In the study, 40 patients with American Society of Anesthesiologists (ASA) physical statuses I-II, aged 19-66 years, scheduled for elective thoracic surgeries under general anesthesia requiring orotracheal intubation were allocated to either the double-lumen endobronchial intubation (T group) or double-lumen endobronchial intubation after epidural administration of lidocaine (E group). After an intravenous anesthetic induction, the orotracheal double-lumen intubation was performed using a Macintosh direct laryngoscopy (MDLS), respectively. Invasive blood pressure (BP), heart rate (HR) and bispectral index (BIS) were recorded before and after anesthetic induction, immediately after intubation and 5 minutes after intubation with 1-minute interval and the intubation time also noted. The rate pressure product (RPP) was calculated.
RESULTS


After anesthetic induction, BP and RPP in the two groups decreased significantly compared with their preinduction values. In comparison with their postinduction values, the orotracheal intubation in the two groups caused significant increases in BPs, HRs and RPP. In comparison with their preinduction values, BPs decreased significantly in E group, systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) increased significantly and lasted for 1 min in T group. The HRs of both groups after intubation were significantly higher than their baseline values , and increased in HR and lasted for 1 min and 4 min in E group and T group, respectively. SBP, DBP, MAP, HR and RPP after intubation in T group were significantly higher than those of E group during the observation period. The values of BIS were similar between both the groups. In T group, the incidences of SBP percent increased>30% of the baseline value and RPP more than 22 000 were significantly higher than in E group. None of the patients in group E had SBP more than 130% of the baseline value and RPP more than 22 000.
CONCLUSION


During double-lumen endobronchial intubation, epidural administration of lidocaine can provide less hemodynamic response and similar arousal response.",2019,"SBP, DBP, MAP, HR and RPP after intubation in T group were significantly higher than those of E group during the observation period.","['double lumen tracheal intubation during induction of anesthesia', '40 patients with American Society of Anesthesiologists (ASA) physical statuses I-II, aged 19-66 years, scheduled for elective thoracic surgeries under general anesthesia requiring orotracheal intubation']","['double-lumen endobronchial intubation (T group) or double-lumen endobronchial intubation', 'lidocaine', 'During double-lumen endobronchial intubation']","['BP and RPP', 'rate pressure product (RPP', 'BPs, HRs and RPP', 'Invasive blood pressure (BP), heart rate (HR) and bispectral index (BIS', 'systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP', 'hemodynamic and arousal responses', 'hemodynamic response and similar arousal response', 'SBP, DBP, MAP, HR and RPP after intubation', 'SBP', 'values of BIS', 'BPs']","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation (procedure)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0396632', 'cui_str': 'Endobronchial intubation (procedure)'}, {'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1270999', 'cui_str': 'Invasive blood pressure (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.0674837,"SBP, DBP, MAP, HR and RPP after intubation in T group were significantly higher than those of E group during the observation period.","[{'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, Peking University International Hospital, Beijing 102206, China.'}, {'ForeName': 'W X', 'Initials': 'WX', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Peking University International Hospital, Beijing 102206, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,['10.19723/j.issn.1671-167X.2019.04.026']
1091,30686609,A Triple-Blind Randomized Trial of Preemptive Use of Gabapentin Before Laparoscopic Hysterectomy for Benign Gynaecologic Conditions.,"OBJECTIVE


This study sought to examine the efficacy of preemptive use of gabapentin in laparoscopic hysterectomy for benign gynaecologic conditions.
METHODS


In a triple-blind trial, the study investigators randomly assigned women undergoing laparoscopic hysterectomy to receive 600 mg gabapentin (n = 43) or placebo (n = 45) orally 1 hour before the procedure. Patient-controlled opioid analgesia was provided postoperatively. The primary outcome of the trial was cumulative opioid consumption in the first postoperative 24 hours. The study also assessed pain at rest and on movement, the presence of side effects, and patient satisfaction at 2, 8, and 24 hours after surgery.
RESULTS


Between March 10, 2016 and May 1, 2018, 215 women were assessed for eligibility, 110 were randomized, and 88 completed the study. Enrolment was started after trial registration. The investigators found no difference in 24-hour cumulative morphine equivalent opioid consumption between the gabapentin group (26.9 ± 14.7 mg) and the placebo group (27.1 ± 15.1 mg). This provided a mean difference of 0.2 mg (95% CI -6.1 to 6.5, P = 0.943). Pain scores at 2, 8, and 24 hours were also not found to differ between groups. Gabapentin was associated with increased dizziness, but it significantly reduced the use of antiemetic at any time in the first 24 postoperative hours. Patient satisfaction in the two groups was good and not found to differ.
CONCLUSION


Preemptive administration of gabapentin before laparoscopic hysterectomy does not decrease postoperative pain scores and narcotic consumption.",2019,"Patient satisfaction in the two groups was good and not found to differ.
","['Between March 10, 2016 and May 1, 2018, 215 women were assessed for eligibility, 110 were randomized, and 88 completed the study', 'Benign Gynaecologic Conditions']","['placebo', 'Gabapentin', 'Laparoscopic Hysterectomy', 'gabapentin', 'laparoscopic hysterectomy', 'laparoscopic hysterectomy to receive 600 mg gabapentin']","['postoperative pain scores and narcotic consumption', 'Patient satisfaction', '24-hour cumulative morphine equivalent opioid consumption', 'Pain scores', 'cumulative opioid consumption', 'dizziness']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",215.0,0.511221,"Patient satisfaction in the two groups was good and not found to differ.
","[{'ForeName': 'Togas', 'Initials': 'T', 'LastName': 'Tulandi', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC. Electronic address: togas.tulandi@mcgill.ca.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Fady', 'Initials': 'F', 'LastName': 'Mansour', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Suarthana', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Al-Malki', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Luz Esther Ramos', 'Initials': 'LER', 'LastName': 'Ballesteros', 'Affiliation': 'Department of Obstetrics and Gynecology, McGill University, Montréal QC.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'Department of Anesthesia, McGill University, Montréal QC.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.11.019']
1092,32441870,"Ripple Effects of a Community-Based Randomized Trial for Rural Women: Strong Hearts, Healthy Communities.","OBJECTIVE


This study aimed to examine (1) whether the Strong Hearts, Healthy Communities intervention (SHHC) improved social network members' (SNMs') weight, exercise, and diet and (2) whether SNMs' weight and behavioral changes were modified by their relationship closeness and/or spatial closeness with trial participants.
METHODS


Eight towns received the SHHC intervention, which focused on building individual healthy behaviors and creating supportive social and built environments for exercise and healthy eating. Eight towns received an education-only control intervention. SNMs (n = 487) were recruited to complete a questionnaire at baseline and at 6 months that asked about demographics, weight, height, exercise, and eating habits.
RESULTS


SHHC's effect on SNMs differed depending on their relationship closeness with trial participants. Among SNMs who had a very close relationship with trial participants, those associated with the intervention group lost more weight and decreased BMI more than those associated with the control group (weight [kilograms] between-group difference: Δ = -1.68; 95% CI: -3.10 to -0.25; P = 0.021; BMI between-group difference: Δ = -0.60; 95% CI: -1.16 to -0.04; P = 0.034). Spatial closeness did not modify any of SHHC's ripple effects.
CONCLUSIONS


Relationship closeness, rather than spatial closeness, played an important role in influencing a rural community-based intervention's ripple effects.",2020,"Spatial closeness did not modify any of SHHC's ripple effects.
","['Rural Women: Strong Hearts, Healthy Communities', 'SNMs (n\xa0=\xa0487', 'Eight towns received the']","['SHHC intervention, which focused on building individual healthy behaviors and creating supportive social and built environments for exercise and healthy eating', ""Strong Hearts, Healthy Communities intervention (SHHC) improved social network members' (SNMs') weight, exercise, and diet and (2) whether SNMs' weight"", 'education-only control intervention']",['weight and decreased BMI'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4505382', 'cui_str': 'Built Environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}]",487.0,0.0803002,"Spatial closeness did not modify any of SHHC's ripple effects.
","[{'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Lo', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University, College Station, Texas, USA.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Donoso', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': 'Bassett Research Institute, Bassett Healthcare Network, Cooperstown, New York, USA.'}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts, USA.'}, {'ForeName': 'Lynn C', 'Initials': 'LC', 'LastName': 'Paul', 'Affiliation': 'College of Education, Health and Human Development, Montana State University, Bozeman, Montana, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Cornell Statistical Consulting Unit, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Texas A&M AgriLife Research, Texas A&M University, College Station, Texas, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22817']
1093,30481269,"The Effect of Preexisting Immunity on Virus Detection and Immune Responses in a Phase II, Randomized Trial of a Russian-Backbone, Live, Attenuated Influenza Vaccine in Bangladeshi Children.","BACKGROUND


In a 2012 Phase II clinical trial, 300 Bangladeshi children aged 24 to 59 months with no prior influenza vaccine exposure were randomized to receive a single intranasally-administered dose of either trivalent, Russian-backbone, live, attenuated influenza vaccine (LAIV) or placebo. Protocol-defined analyses, presented in the companion manuscript, demonstrate decreased viral detection and immunogenicity for A/H1N1pdm09, relative to the A/H3N2 and B strains. This post hoc analysis of the trial data aims to investigate the LAIV strain differences by testing the hypothesis that preexisting humoral and mucosal immunity may influence viral recovery and immune responses after LAIV receipt.
METHODS


We used logistic regressions to evaluate the relations between markers of preexisting immunity (ie, hemagglutination inhibition [HAI], microneutralization, and immunoglobulin G and immunoglobulin A (both serum and mucosal antibodies) and LAIV viral recovery in the week post-vaccination. We then tested for potential effect modification by baseline HAI titers (ie, <10 versus ≥10) and week 1 viral recovery on the LAIV-induced serum and mucosal immune responses, measured between days 0 and 21 post-vaccination.
RESULTS


Higher levels of preexisting immunity to influenza A/H3N2 and B were strongly associated with strain-specific prevention of viral shedding upon LAIV receipt. While evidence of LAIV immunogenicity was observed for all 3 strains, the magnitudes of immune responses were most pronounced in children with no evidence of preexisting HAI and in those with detectable virus.
CONCLUSIONS


The results provide evidence for a bidirectional association between viral replication and immunity, and underscore the importance of accounting for preexisting immunity when evaluating virologic and immunologic responses to LAIVs.
CLINICAL TRIALS REGISTRATION


NCT01625689.",2019,Higher levels of pre-existing immunity to influenza A/H3N2 and B were strongly associated with strain-specific prevention of viral shedding upon LAIV receipt.,"['300 Bangladeshi children aged 24 to 59 months with no prior influenza vaccine exposure', 'Bangladeshi children']","['Russian-backbone live attenuated influenza vaccine', 'pre-existing immunity', 'intra-nasally administered trivalent Russian-backbone live attenuated influenza vaccine (LAIV) or placebo']","['LAIV immunogenicity', 'pre-existing immunity (i.e., hemagglutination inhibition (HAI), microneutralization, and IgA and IgG antibodies) and LAIV viral recovery', 'LAIV-induced serum and mucosal immune responses', 'baseline HAI titers', 'viral detection and immunogenicity']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0282557', 'cui_str': 'Immune Response, Mucosal'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",300.0,0.153512,Higher levels of pre-existing immunity to influenza A/H3N2 and B were strongly associated with strain-specific prevention of viral shedding upon LAIV receipt.,"[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Brickley', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, United Kingdom.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Wright', 'Affiliation': 'Department of Pediatrics, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Khalenkov', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, United Kingdom.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Rudenko', 'Affiliation': 'Department of Virology, Institute of Experimental Medicine, Saint Petersburg, Russia.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Katz', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'W Abdullah', 'Initials': 'WA', 'LastName': 'Brooks', 'Affiliation': 'Department of International Health, Johns Hopkins University, Baltimore, Maryland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1004']
1094,32441474,Impact of Combined Hormonal Contraceptive Use on Weight Loss: A Secondary Analysis of a Behavioral Weight-Loss Trial.,"OBJECTIVE


This study aimed to perform a preliminary investigation of the impact of combined hormonal contraceptive (CHC) use on weight loss during an 18-month behavioral weight-loss trial.
METHODS


Adults (n = 170; 18-55 years; BMI 27-42 kg/m 2  ) received a weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support. Premenopausal women (n = 110) were classified as CHC users (CHC, n = 17) or non-CHC users (non-CHC, n = 93). Changes in weight were examined within groups using a linear mixed model, adjusted for age and randomized group assignment.
RESULTS


At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg). Between 6 and 18 M, CHC regained weight (4.9 kg; 0.9 to 8.9 kg), while weight remained relatively unchanged in non-CHC (-0.1 kg; -1.8 to 1.6 kg). At 18 M, weight was relatively unchanged from baseline in CHC (-1.8 kg; -7.3 to 3.6 kg) and was reduced from baseline in non-CHC (-7.9 kg; -10.2 to -5.5 kg).
CONCLUSIONS


In this secondary data analysis, CHC use was associated with weight regain after initial weight loss. Prospective studies are needed to further understand the extent to which CHC use influences weight loss and maintenance.",2020,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","['Adults (n\u2009=\u2009170; 18-55 years; BMI 27-42 kg/m 2  ', 'Premenopausal women (n\u2009=\u2009110) were classified as CHC users (CHC, n\u2009=\u200917) or non-CHC users (non-CHC, n\u2009=\u200993']","['combined hormonal contraceptive (CHC', 'Combined Hormonal Contraceptive', 'weight-loss intervention that included a reduced-calorie diet, a progressive exercise prescription, and group-based behavioral support']","['weight regain', 'weight loss', 'CHC regained weight', 'Weight Loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",,0.0745885,"At 6 M, weight was reduced from baseline in both CHC (mean, -6.7 kg; 95% CI: -9.8 to -3.7 kg) and non-CHC (-9.1 kg; -9.1 to -6.4 kg).","[{'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Adnin', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Ostendorf', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Bryan B', 'Initials': 'BB', 'LastName': 'Swanson', 'Affiliation': 'Department of Chemistry and Biochemistry, Colorado College, Colorado Springs, Colorado, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Kinesiology and Public Health Department, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Catenacci', 'Affiliation': 'Anschutz Health and Wellness Center, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22787']
1095,32133503,Identification of Milk and Cheese Intake Biomarkers in Healthy Adults Reveals High Interindividual Variability of Lewis System-Related Oligosaccharides.,"BACKGROUND


The use of biomarkers of food intake (BFIs) in blood and urine has shown great promise for assessing dietary intake and complementing traditional dietary assessment tools whose use is prone to misreporting.
OBJECTIVE


Untargeted LC-MS metabolomics was applied to identify candidate BFIs for assessing the intake of milk and cheese and to explore the metabolic response to the ingestion of these foods.
METHODS


A randomized controlled crossover study was conducted in healthy adults [5 women, 6 men; age: 23.6 ± 5.0 y; BMI (kg/m2): 22.1 ± 1.7].  After a single isocaloric intake of milk (600 mL), cheese (100 g), or soy-based drink (600 mL), serum and urine samples were collected postprandially up to 6 h and after fasting after 24 h. Untargeted metabolomics was conducted using LC-MS. Discriminant metabolites were selected in serum by multivariate statistical analysis, and their mass distribution and postprandial kinetics were compared.
RESULTS


Serum metabolites discriminant for cheese intake had a significantly lower mass distribution than metabolites characterizing milk intake (P = 4.1 × 10-4). Candidate BFIs for milk or cheese included saccharides, a hydroxy acid, amino acids, amino acid derivatives, and dipeptides. Two serum oligosaccharides, blood group H disaccharide (BGH) and Lewis A trisaccharide (LeA), specifically reflected milk intake but with high interindividual variability. The 2 oligosaccharides showed related but opposing trends: subjects showing an increase in either oligosaccharide did not show any increase in the other oligosaccharide. This result was confirmed in urine.
CONCLUSIONS


New candidate BFIs for milk or cheese could be identified in healthy adults, most of which were related to protein metabolism. The increase in serum of LeA and BGH after cow-milk intake in adults calls for further investigations considering the beneficial health effects on newborns of such oligosaccharides in maternal milk. The trial is registered at clinicaltrials.gov as NCT02705560.",2020,The 2 oligosaccharides showed related but opposing trends: subjects showing an increase in either oligosaccharide did not show any increase in the other oligosaccharide.,"['healthy adults [5 women, 6 men; age: 23.6\xa0±\xa05.0 y; BMI (kg/m2): 22.1\xa0±\xa01.7', 'Healthy Adults', 'healthy adults']",[],"['Two serum oligosaccharides, blood group H disaccharide (BGH) and Lewis A trisaccharide (LeA', 'serum of LeA and BGH']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0005810', 'cui_str': 'Blood Groups'}, {'cui': 'C0012611', 'cui_str': 'Disaccharides'}, {'cui': 'C0646149', 'cui_str': 'A-trisaccharide'}]",,0.0219727,The 2 oligosaccharides showed related but opposing trends: subjects showing an increase in either oligosaccharide did not show any increase in the other oligosaccharide.,"[{'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pimentel', 'Affiliation': 'Federal Department of Economic Affairs, Education, and Research, Agroscope, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burnand', 'Affiliation': 'Federal Department of Economic Affairs, Education, and Research, Agroscope, Bern, Switzerland.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Münger', 'Affiliation': 'Federal Department of Economic Affairs, Education, and Research, Agroscope, Bern, Switzerland.'}, {'ForeName': 'François P', 'Initials': 'FP', 'LastName': 'Pralong', 'Affiliation': 'Service of Endocrinology, Diabetes, and Metabolism, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Vionnet', 'Affiliation': 'Service of Endocrinology, Diabetes, and Metabolism, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Reto', 'Initials': 'R', 'LastName': 'Portmann', 'Affiliation': 'Federal Department of Economic Affairs, Education, and Research, Agroscope, Bern, Switzerland.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vergères', 'Affiliation': 'Federal Department of Economic Affairs, Education, and Research, Agroscope, Bern, Switzerland.'}]",The Journal of nutrition,['10.1093/jn/nxaa029']
1096,28727578,Physical Activity and Survival in Women With Advanced Breast Cancer.,"BACKGROUND


Several empirical investigations have attempted to characterize the effect of physical activity on cancer mortality, but these investigations have rarely focused on patients with advanced breast cancer.
OBJECTIVE


The current study examined the hypothesis that greater physical activity is associated with longer survival among women with advanced breast cancer.
METHODS


We conducted a secondary data analysis of a prospective study of 103 patients with stage IV (n = 100) or locally recurrent (n = 3) breast cancer involved in a group psychotherapy trial. Physical activity was assessed at baseline using the Seven-Day Physical Activity Recall questionnaire, and patients were followed until April 1, 2016, at which time 93 of 103 had died.
RESULTS


Greater physical activity level at baseline was significantly associated with longer subsequent survival time in a Cox proportional hazards model (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.84-0.97; P < .01). Engaging in 1 additional hour per day of moderate activity reduced the hazard of subsequent mortality by 23% (HR, 0.77; 95% CI, 0.65-0.92; P < .01). These results remained significant even after controlling for demographic, medical, cancer, depression, and cortisol variables (HR, 0.91; 95% CI, 0.84-0.99; P < .05).
CONCLUSIONS


Women with advanced breast cancer who engaged in physical activity for 1 or more hours per day at baseline had an increased likelihood of survival compared with those who exercised less than 1 hour per day.
IMPLICATIONS FOR PRACTICE


Nurses should consider recommending moderate physical activity for women with advanced breast cancer. Randomized trials of physical activity interventions for this population are needed.",2018,"Engaging in 1 additional hour per day of moderate activity reduced the hazard of subsequent mortality by 23% (HR, 0.77; 95% CI, 0.65-0.92; P < .01).","['103 patients with stage IV (n = 100) or locally recurrent (n = 3) breast cancer involved in a group psychotherapy trial', 'patients with advanced breast cancer', 'Women With Advanced Breast Cancer', 'Women with advanced breast cancer', 'women with advanced breast cancer']",['physical activity interventions'],"['demographic, medical, cancer, depression, and cortisol variables', 'hazard of subsequent mortality', 'subsequent survival time', 'likelihood of survival', 'Physical activity', 'physical activity level', 'Physical Activity and Survival']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",103.0,0.108177,"Engaging in 1 additional hour per day of moderate activity reduced the hazard of subsequent mortality by 23% (HR, 0.77; 95% CI, 0.65-0.92; P < .01).","[{'ForeName': 'Oxana', 'Initials': 'O', 'LastName': 'Palesh', 'Affiliation': 'Author Affiliations: Department of Psychiatry and Behavioral Sciences, Stanford University, California (Drs Palesh, Neri, Spiegel, and Koopman); Wilmot Cancer Center, University of Rochester, New York (Dr Kamen); and PGSP-Stanford Psy.D. Consortium, Palo Alto University, California (Drs Sharp and Golden).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kamen', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sharp', 'Affiliation': ''}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Neri', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spiegel', 'Affiliation': ''}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Koopman', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000525']
1097,31362081,"Cardiac output, heart rate and stroke volume during targeted temperature management after out-of-hospital cardiac arrest: Association with mortality and cause of death.","AIM


Myocardial dysfunction and low cardiac index are common after out-of-hospital cardiac arrest (OHCA) as part of the post-cardiac arrest syndrome. This study investigates the association of cardiac index during targeted temperature management (TTM) with mortality.
METHODS


In the TTM-trial, which randomly allocated patients to TTM of 33 °C or 36 °C for 24 h, we prospectively and consecutively monitored 151 patients with protocolized measurements from pulmonary artery catheters (PAC) as a single site substudy. Cardiac index, heart rate and stroke volume were measured at 3 time-points during the 24 h TTM period and averaged. Uni- and multivariate Cox regression was used to assess association with mortality.
RESULTS


Of 151 patients, 50 (33%) were deceased after 180 days. Cardiac index during TTM was not significantly associated with mortality in univariate (HR: 0.84 [0.54-1.31], p = 0.59) or multivariate analyses (HR adjusted : 1.03 [0.57-1.83], p = 0.93). Cardiac index during TTM was also not significantly associated with non-neurological death (HR adjusted : 1.25 [0.43-3.59], p = 0.68). Higher heart rate (p = 0.03) and lower stroke volume (p = 0.04) were associated with increased mortality in univariate, but not multivariate analyses. No hemodynamic variables were associated with cerebral death, however, increasing lactate during TTM (HR adjusted : 2.15 [1.19-3.85], p = 0.01) and lower mean arterial pressure during TTM (HR adjusted : 0.89 [0.81-0.97], p = 0.008) were independently associated with non-neurological death.
CONCLUSION


Cardiac index during TTM after resuscitation from OHCA is not associated with mortality. Future studies should investigate whether certain subgroups of patients could benefit from targeting higher goals for cardiac index.",2019,"Higher heart rate (p = 0.03) and lower stroke volume (p = 0.04) were associated with increased mortality in univariate, but not multivariate analyses.","['Of 151 patients, 50 (33%) were deceased after 180 days', '151 patients with protocolized measurements from pulmonary artery catheters (PAC) as a single site substudy']",[],"['lower stroke volume', 'Cardiac index, heart rate and stroke volume', 'non-neurological death', 'Cardiac output, heart rate and stroke volume', 'cerebral death', 'Higher heart rate', 'Cardiac index', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0179790', 'cui_str': 'Swan-Ganz catheter, device'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",151.0,0.0836935,"Higher heart rate (p = 0.03) and lower stroke volume (p = 0.04) were associated with increased mortality in univariate, but not multivariate analyses.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Grand', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Electronic address: johannes.grand@regionh.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bro-Jeppesen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wanscher', 'Affiliation': 'Department of Cardiothoracic Anaesthesia 4142, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Matias Greve', 'Initials': 'MG', 'LastName': 'Lindholm', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jakob Hartvig', 'Initials': 'JH', 'LastName': 'Thomsen', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Boesgaard', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Resuscitation,['10.1016/j.resuscitation.2019.07.024']
1098,31427204,"Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial.","BACKGROUND


In the ongoing phase 3 CheckMate 214 trial, nivolumab plus ipilimumab showed superior efficacy over sunitinib in patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma, with a manageable safety profile. In this study, we aimed to assess efficacy and safety after extended follow-up to inform the long-term clinical benefit of nivolumab plus ipilimumab versus sunitinib in this setting.
METHODS


In the phase 3, randomised, controlled CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to open-label nivolumab (3 mg/kg intravenously) plus ipilimumab (1 mg/kg intravenously) every 3 weeks for four doses, followed by nivolumab (3 mg/kg intravenously) every 2 weeks; or sunitinib (50 mg orally) once daily for 4 weeks (6-week cycle). Randomisation was done through an interactive voice response system, with a block size of four and stratified by risk status and geographical region. The co-primary endpoints for the trial were overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients. Secondary endpoints were overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events in all treated patients. In this Article, we report overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety after extended follow-up. Efficacy outcomes were assessed in all randomly assigned patients; safety was assessed in all treated patients. This study is registered with ClinicalTrials.gov, number NCT02231749, and is ongoing but now closed to recruitment.
FINDINGS


Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients were randomly assigned to nivolumab plus ipilimumab or sunitinib (550 vs 546 in the intention-to-treat population; 425 vs 422 intermediate-risk or poor-risk patients, and 125 vs 124 favourable-risk patients). With extended follow-up (median follow-up 32·4 months [IQR 13·4-36·3]), in intermediate-risk or poor-risk patients, results for the three co-primary efficacy endpoints showed that nivolumab plus ipilimumab continued to be superior to sunitinib in terms of overall survival (median not reached [95% CI 35·6-not estimable] vs 26·6 months [22·1-33·4]; hazard ratio [HR] 0·66 [95% CI 0·54-0·80], p<0·0001), progression-free survival (median 8·2 months [95% CI 6·9-10·0] vs 8·3 months [7·0-8·8]; HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001). Similarly, in intention-to-treat patients, nivolumab and ipilimumab showed improved efficacy compared with sunitinib in terms of overall survival (median not reached [95% CI not estimable] vs 37·9 months [32·2-not estimable]; HR 0·71 [95% CI 0·59-0·86], p=0·0003), progression-free survival (median 9·7 months [95% CI 8·1-11·1] vs 9·7 months [8·3-11·1]; HR 0·85 [95% CI 0·73-0·98], p=0·027), and the proportion of patients achieving an objective response (227 [41%] of 550 vs 186 [34%] of 546 p=0·015). In all treated patients, the most common grade 3-4 treatment-related adverse events in the nivolumab and ipilimumab group were increased lipase (57 [10%] of 547), increased amylase (31 [6%]), and increased alanine aminotransferase (28 [5%]), whereas in the sunitinib group they were hypertension (90 [17%] of 535), fatigue (51 [10%]), and palmar-plantar erythrodysaesthesia (49 [9%]). Eight deaths in the nivolumab plus ipilimumab group and four deaths in the sunitinib group were reported as treatment-related.
INTERPRETATION


The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate-risk or poor-risk and intention-to-treat patients with extended follow-up, and show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories.
FUNDING


Bristol-Myers Squibb and ONO Pharmaceutical.",2019,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","['patients aged 18 years and older with previously untreated, advanced, or metastatic histologically confirmed renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries', 'Patients were categorised by International Metastatic Renal Cell Carcinoma Database Consortium risk status into favourable-risk, intermediate-risk, and poor-risk subgroups and randomly assigned (1:1) to', 'advanced renal cell carcinoma', 'patients with previously untreated advanced renal cell carcinoma across all risk categories', 'Between Oct 16, 2014, and Feb 23, 2016, of 1390 patients screened, 1096 (79%) eligible patients', 'patients with previously untreated intermediate-risk or poor-risk advanced renal cell carcinoma']","['nivolumab plus ipilimumab or sunitinib', 'Nivolumab plus ipilimumab versus sunitinib', 'open-label nivolumab (3 mg/kg intravenously) plus ipilimumab', 'sunitinib', 'nivolumab plus ipilimumab']","['Efficacy outcomes', 'fatigue', 'alanine aminotransferase', 'overall survival, progression-free survival per independent radiology review committee (IRRC), and objective responses per IRRC in intermediate-risk or poor-risk patients', 'overall survival', 'adverse events', 'increased amylase', 'progression-free survival', 'overall survival, progression-free survival per IRRC, and objective responses per IRRC in the intention-to-treat population, and adverse events', 'progression-free survival ', 'efficacy', 'efficacy and safety', 'hypertension', 'palmar-plantar erythrodysaesthesia', 'proportion of patients achieving an objective response', 'overall survival, investigator-assessed progression-free survival, investigator-assessed objective response, characterisation of response, and safety', 'lipase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517571', 'cui_str': '1390 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",1390.0,0.285576,"HR 0·77 [95% CI 0·65-0·90], p=0·0014), and the proportion of patients achieving an objective response (178 [42%] of 425 vs 124 [29%] of 422; p=0·0001).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology and Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Arén Frontera', 'Affiliation': 'Department of Medical Oncology, Centro de Invetigación Clínica Bradford Hill, Santiago, Chile.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Hammers', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Oncology and Urology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Salman', 'Affiliation': 'Department of Medical Oncology, Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Beuselinck', 'Affiliation': 'Department of Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Levine Cancer Institute, Atrium Healthcare, Charlotte, NC, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Neiman', 'Affiliation': 'Department of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel; Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Department of Oncology, Ospedale San Donato, Azienda USL Toscana Sud-Est, IstitutoToscanoTumori, Arezzo, Italy.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Department of Medical Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Raya', 'Initials': 'R', 'LastName': 'Leibowitz-Amit', 'Affiliation': 'Oncology Department, Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Sjoukje F', 'Initials': 'SF', 'LastName': 'Oosting', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redman', 'Affiliation': 'Department of Internal Medicine, Division of Hematology and Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Department of Cancer Services: Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Service de Cancérologie Médicale Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pook', 'Affiliation': 'Department of Oncology, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Division of Medical Oncology, Duke Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Urology, Niigata University, Niigata, Japan.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Interdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Sabeen', 'Initials': 'S', 'LastName': 'Mekan', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30413-9']
1099,31681981,Improved Quality of Death and Dying in Care Homes: A Palliative Care Stepped Wedge Randomized Control Trial in Australia.,"OBJECTIVES


Mortality in care homes is high, but care of dying residents is often suboptimal, and many services do not have easy access to specialist palliative care. This study examined the impact of providing specialist palliative care on residents' quality of death and dying.
DESIGN


Using a stepped wedge randomized control trial, care homes were randomly assigned to crossover from control to intervention using a random number generator. Analysis used a generalized linear and latent mixed model. The trial was registered with ANZCTR: ACTRN12617000080325.
SETTING


Twelve Australian care homes in Canberra, Australia.
PARTICIPANTS


A total of 1700 non-respite residents were reviewed from the 12 participating care homes. Of these residents, 537 died and 471 had complete data for analysis. The trial ran between February 2017 and June 2018.
INTERVENTION


Palliative Care Needs Rounds (hereafter Needs Rounds) are monthly hour-long staff-only triage meetings to discuss residents at risk of dying without a plan in place. They are chaired by a specialist palliative care clinician and attended by care home staff. A checklist is followed to guide discussions and outcomes, focused on anticipatory planning.
MEASUREMENTS


This article reports secondary outcomes of staff perceptions of residents' quality of death and dying, care home staff confidence, and completion of advance care planning documentation. We assessed (1) quality of death and dying, and (2) staff capability of adopting a palliative approach, completion of advance care plans, and medical power of attorney.
RESULTS


Needs Rounds are associated with staff perceptions that residents had a better quality of death and dying (P < .01; 95% confidence interval [CI] = 1.83-12.21), particularly in the 10 facilities that complied with the intervention protocol (P < .01; 95% CI = 6.37-13.32). Staff self-reported perceptions of capability increased (P < .01; 95% CI = 2.73-6.72).
CONCLUSION


The data offer evidence for monthly triage meetings to transform the lives, deaths, and care of older people residing in care homes. J Am Geriatr Soc 68:305-312, 2020.",2020,"Staff self-reported perceptions of capability increased (P < .01; 95% CI = 2.73-6.72).
","['Twelve Australian care homes in Canberra, Australia', 'A total of 1700 non-respite residents were reviewed from the 12 participating care homes', 'The trial ran between February 2017 and June 2018', 'Care Homes']",[],"['quality of death and dying', 'quality of death and dying, and (2) staff capability of adopting a palliative approach, completion of advance care plans, and medical power of attorney', 'Improved Quality of Death and Dying']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]",[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4544311', 'cui_str': 'Advance care plan (record artifact)'}, {'cui': 'C0524772', 'cui_str': 'Medical Power of Attorney'}]",12.0,0.204914,"Staff self-reported perceptions of capability increased (P < .01; 95% CI = 2.73-6.72).
","[{'ForeName': 'Wai-Man', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'University of Canberra, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'University Technology Sydney, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Johnston', 'Affiliation': 'Calvary Public Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Samara', 'Affiliation': 'Calvary Public Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chapman', 'Affiliation': 'Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Forbat', 'Affiliation': 'Australian Catholic University, Canberra, Australian Capital Territory, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16192']
1100,31421394,"Suppression of sweet sensing with glucose, but not aspartame, delays gastric emptying and glycemic response.","Previously, we reported that oral stimulation with Gymnema sylvestre (GS), a plant that selectively suppresses sweet taste sensation in humans, delayed gastric emptying and glycemic response during and after oral glucose ingestion. It is unclear whether these responses are triggered by sweet taste sensing per se. We tested the hypothesis that the effects of sweet taste sensing involving a low-energy sweetener, aspartame, alters gastric emptying, blood glucose, and plasma insulin responses during and after the prandial phase. Nine participants rinsed their mouths with either 25 mL of water (control) or a 2.5% GS solution, and then ingested 200 g (50 g × four times) of either 0.09% aspartame or 15% glucose solution containing 100 mg of  13 C-sodium acetate. Gastric emptying was measured with a  13 C breath test. Blood glucose and plasma insulin were measured at baseline as well as during and after ingestion of the sweet solutions. Decreased subjective sweet taste intensity was observed in the GS group for both the aspartame and glucose trials. In the aspartame trial, no measurements showed significant differences between either group. In the glucose trial, gastric emptying was delayed in the GS group compared to controls. In the initial phase, both during and after glucose ingestion in the glucose trial, blood glucose and plasma insulin responses were lower in the GS group than the controls. The presence or absence of sweet taste-sensing involving glucose had a significant effect on gastric emptying and glycemic metabolism, both during and after the prandial phase, as opposed to the effects involving aspartame.",2019,"The presence or absence of sweet taste-sensing involving glucose had a significant effect on gastric emptying and glycemic metabolism, both during and after the prandial phase, as opposed to the effects involving aspartame.",[],"['25\u202fmL of water (control) or a 2.5% GS solution', '0.09% aspartame or 15% glucose solution containing 100 mg of  13 C-sodium acetate', 'Gymnema sylvestre (GS']","['subjective sweet taste intensity', 'Blood glucose and plasma insulin', 'blood glucose and plasma insulin responses', 'gastric emptying and glycemic response', 'aspartame, delays gastric emptying and glycemic response', 'gastric emptying', 'gastric emptying and glycemic metabolism', 'gastric emptying, blood glucose, and plasma insulin responses', 'Gastric emptying']",[],"[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4517419', 'cui_str': 'Zero point zero nine'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0729631', 'cui_str': 'C-13 isotope'}, {'cui': 'C0142785', 'cui_str': 'Sodium Acetate'}, {'cui': 'C0996922', 'cui_str': 'Gurmar'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",9.0,0.0339235,"The presence or absence of sweet taste-sensing involving glucose had a significant effect on gastric emptying and glycemic metabolism, both during and after the prandial phase, as opposed to the effects involving aspartame.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kashima', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima, 734-8558, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Taniyama', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima, 734-8558, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima, 734-8558, Japan.'}, {'ForeName': 'Masako Yamaoka', 'Initials': 'MY', 'LastName': 'Endo', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima, 734-8558, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Health Promotion and Development, Graduate School of Health Sciences, Hiroshima University, 1-2-3 Kasumi Minami-ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Fukuba', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima, 734-8558, Japan. Electronic address: fukuba@pu-hiroshima.ac.jp.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.06.005']
1101,31433108,Randomized Trial of 3 Techniques of Perineal Skin Closure During Second-Degree Perineal Laceration Repair.,"INTRODUCTION


Perineal lacerations during childbirth are common, and suturing the perineal skin during repair has been associated with increased postpartum pain. This study sought to test the hypothesis that no difference in postpartum perineal pain exists between 3 methods of skin closure for second-degree repair: suture, no suture, and surgical glue.
METHODS


A single-blind randomized controlled trial of women after vaginal birth who had a second-degree perineal laceration was conducted at a tertiary care teaching hospital from August 2014 to April 2017. Women were randomized to perineal skin closure with suture, no suture, or surgical glue using a 1:1:1 allocation. Pain was assessed using the short-form McGill Pain Questionnaire, a 100-mm visual analog scale (VAS), and Present Pain Index (PPI) at one day, 2 weeks, 6 weeks, and 3 months postpartum. Wound healing was assessed at 6 weeks using the Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA) scale. Pain scores were compared across groups using a chi-square test, Mann-Whitney U test, or analysis of variance where appropriate.
RESULTS


A total of 35 women were randomized: 14 received suture, 11 had no suture, and 10 received surgical glue for perineal skin repair. Demographic characteristics were similar between groups. At 2 weeks postpartum, women with suture had higher median pain scores on the short-form McGill Pain Questionnaire (15.0 suture vs 2.0 glue vs 2.0 no suture, P = .03) and VAS (50.0 suture vs 3.0 glue vs 7.0 no suture, P = .02). Significant differences in pain were not seen on the PPI. At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04). Wound healing was similar across groups (REEDA score: 0 suture vs 1.0 no suture, vs 0 surgical glue, P = .24).
DISCUSSION


Compared with no suture and surgical glue, suturing the perineal skin was associated with the highest postpartum pain scores.",2019,"At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04).","['women after vaginal birth who had a second-degree perineal laceration was conducted at a tertiary care teaching hospital from August 2014 to April 2017', '35 women were randomized: 14 received']","['perineal skin closure with suture, no suture, or surgical glue using a 1:1:1 allocation', 'suture, 11 had no suture, and 10 received surgical glue for perineal skin repair', 'Perineal Skin Closure', 'skin closure for second-degree repair: suture, no suture, and surgical glue']","['McGill Pain Questionnaire', 'Demographic characteristics', 'short-form McGill Pain Questionnaire, a 100-mm visual analog scale (VAS), and Present Pain Index (PPI', 'pain', 'Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA) scale', 'highest postpartum pain scores', 'median pain scores', 'Wound healing', 'Pain scores', 'VAS', 'Pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0269870', 'cui_str': 'Second degree perineal laceration (disorder)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0017780', 'cui_str': 'Glues'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}]","[{'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",35.0,0.144383,"At 3 months, women in the suture group had higher median pain scores on the short-form McGill Pain Questionnaire compared with surgical glue (1.0 vs 0, P = .04).","[{'ForeName': 'Carolyn W', 'Initials': 'CW', 'LastName': 'Swenson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa Kane', 'Initials': 'LK', 'LastName': 'Low', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Kowalk', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Dee E', 'Initials': 'DE', 'LastName': 'Fenner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.'}]",Journal of midwifery & women's health,['10.1111/jmwh.13020']
1102,32495016,Postoperative comparison of laparoscopic radical resection and open abdominal radical hysterectomy for cervical cancer patient.,"PURPOSE


There are limited data regarding postoperative complications and autoimmune reactions caused by surgery in early-stage cervical cancer patients who underwent laparoscopic radical resection (LRR). This study aimed to investigate the therapeutic effect of LRR of cervical cancer patients and its effect on cytokines.
METHODS


168 patients with cervical cancer were enrolled. The patients were divided into open group and laparoscopic group according to the random number table method, with 84 cases in each group. The surgical-related indexes and the incidence of complications of the two groups were observed, and the IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood were compared before and after surgery in both groups.
RESULTS


The operation time of the patients in the laparoscopic group was significantly shorter than that in the open group (119.56 ± 45.26 vs. 206.36 ± 54.39, P < 0.01). The intraoperative blood loss in the laparoscopic group was significantly less than that in the open group (155.29 ± 57.58 vs. 529.58 ± 162.4, P < 0.01). The postoperative visual analog scale (VAS) score was also significantly lower than that in the open group (3.65 ± 0.88 vs. 6.32 ± 1.12, P < 0.01). There was no significant difference in the incidence of complications between the two groups. The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
CONCLUSIONS


LRR surgery has less stress on patients with early cervical cancer than open surgery within 5 days after surgery, which has certain reference value for early cervical cancer treatment.",2020,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
","['168 patients with cervical cancer were enrolled', 'early-stage cervical cancer patients who underwent', 'cervical cancer patient', 'cervical cancer patients', 'patients with early cervical cancer']","['laparoscopic radical resection and open abdominal radical hysterectomy', 'laparoscopic', 'laparoscopic radical resection (LRR', 'LRR surgery']","['IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood', 'degree of inflammatory cytokines changes', 'postoperative visual analog scale (VAS) score', 'intraoperative blood loss', 'incidence of complications', 'operation time']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",168.0,0.0199014,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001).
","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. yinianwuji212@163.com.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. hcfy98@126.com.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05606-2']
1103,32437690,Effect of Anodal Transcranial Direct Current Stimulation at the Right Dorsolateral Prefrontal Cortex on the Cognitive Function in Patients With Mild Cognitive Impairment: A Randomized Double-Blind Controlled Trial.,"OBJECTIVES


To study the effect of anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC) on cognitive function and side effects in patients with mild cognitive impairment.
DESIGN


Experimental double-blind randomized, sham-controlled trial.
SETTING


Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital PARTICIPANTS: Volunteers (N=45) with mild cognitive impairment.
INTERVENTIONS


Not applicable.
MAIN OUTCOME MEASURES


The atDCS group (n=23) were stimulated at 2 mA for 20 minutes with the anode on the right DLPFC and the cathode on the left supraorbital area. The control group (n=22) received placebo stimulation. Baseline cognitive function was assessed using the Cambridge Neuropsychological Test Automated Battery test. Participants were treated 3 times per week for 4 weeks (12 sessions). Cognitive function and side effects were assessed immediately after the first stimulation, the last session, and 4 weeks after treatment.
RESULTS


Cambridge Neuropsychological Test Automated Battery results revealed a significant improvement in the accuracy of the visual sustained attention (VSA) in the atDCS group at all 3 time points, the spatial working memory and visual memory (VM) immediately after the first stimulation, and a decreased VM reaction time after 12 sessions. A long-lasting effect on VSA and VM were found 4 weeks after treatment.
CONCLUSIONS


Anodal tDCS over the right DLPFC enhanced the VSA, spatial working memory, and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions. A long-lasting effect on VSA and VM was found 4 weeks after treatment. This study corroborated atDCS as a safe technique to improve cognitive function.",2020,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[' Participants (45) who met the inclusion criteria', 'patients with mild cognitive impairment', 'Department of Rehabilitation Medicine, Tertiary Hospital SUBJECTS', 'patients with mild cognitive impairment (MCI']","['anodal transcranial direct current stimulation', 'anodal transcranial direct stimulation (atDCS) of the right dorsolateral prefrontal cortex (DLPFC', 'placebo stimulation']","['Baseline cognitive function', 'reaction time of VM', 'VSA, SWM and VM accuracy', 'spatial working memory (SWM) and visual memory (VM', 'Cognitive function and side effects', 'VM reaction time', 'cognitive function', 'accuracy of the visual sustained attention (VSA', 'VSA and VM', 'Cambridge Neuropsychological Test Automated Battery (CANTAB) test', 'cognitive function and side effects']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",45.0,0.0855784,"Anodal tDCS over the right DLPFC enhanced the VSA, SWM and VM accuracy after the first stimulation and reduced the reaction time of VM after 12 sessions.","[{'ForeName': 'Chernkhuan', 'Initials': 'C', 'LastName': 'Stonsaovapak', 'Affiliation': 'Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Solaphat', 'Initials': 'S', 'LastName': 'Hemrungroj', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of Neuroscience Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Terachinda', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Krisna', 'Initials': 'K', 'LastName': 'Piravej', 'Affiliation': 'Department of Neuroscience Center, King Chulalongkorn Memorial Hospital, Bangkok, Thailand; Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: Krisna.P@chula.ac.th.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.023']
1104,31425577,"Testosterone for Androgen Deficiency-Like Symptoms in Men Without Pathologic Hypogonadism: A Randomized, Placebo-Controlled Cross-over With Masked Choice Extension Clinical Trial.","BACKGROUND


Off-label testosterone prescribing for androgen deficiency (AD)-like sexual and energy symptoms of older men without pathologic hypogonadism has increased dramatically without convincing evidence of efficacy.
METHODS


In a randomized, double-blind, placebo-controlled study with three phases, we entered 45 men aged at least 40 years without pathologic hypogonadism but with AD-like energy and/or sexual symptoms to either daily testosterone or placebo gel treatment for 6 weeks in a cross-over study design with a third, mandatory extension phase in which participants chose which previous treatment they preferred to repeat while remaining masked to their original treatment. Primary endpoints were energy and sexual symptoms as assessed by a visual analog scale (Lead Symptom Score [LSS]).
RESULTS


Increasing serum testosterone to the healthy young male range produced no significant benefit more than placebo for energy or sexual LSS. Covariate effects of age, body mass index, and pretreatment baseline serum testosterone on quality-of-life scales were detected. Only 1 out of 22 indices from seven quality-of-life scales was significantly improved by testosterone treatment over placebo. Participants did not choose testosterone significantly more than placebo as their preferred treatment in the third phase.
CONCLUSIONS


Six-week testosterone treatment does not improve energy or sexual symptoms more than placebo in symptomatic men without pathologic hypogonadism.",2020,"RESULTS


Increasing serum testosterone to the healthy young male range produced no significant benefit more than placebo for energy or sexual LSS.","['older men without pathologic hypogonadism', 'symptomatic men without pathologic hypogonadism', 'Men Without Pathologic Hypogonadism', '45 men aged at least 40 years without pathologic hypogonadism but with AD-like energy and/or sexual symptoms to either daily', 'treatment for 6 weeks in a cross-over study design with a third, mandatory extension phase in which participants chose which previous treatment they preferred to repeat while remaining masked to their original treatment']","['testosterone or placebo gel', 'Placebo', 'Testosterone', 'placebo']","['energy and sexual symptoms as assessed by a visual analog scale (Lead Symptom Score (LSS', 'energy or sexual symptoms', 'quality of life scales']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0425722', 'cui_str': 'Sexual symptom (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}]",45.0,0.671427,"RESULTS


Increasing serum testosterone to the healthy young male range produced no significant benefit more than placebo for energy or sexual LSS.","[{'ForeName': 'Shao Feng', 'Initials': 'SF', 'LastName': 'Mok', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fennell', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Savkovic', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Turner', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Jayadev', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Conway', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Handelsman', 'Affiliation': 'Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz195']
1105,31369676,Three-dimensional evaluation of forced unilateral posterior crossbite correction in the mixed dentition: a randomized controlled trial.,"OBJECTIVES


The objectives of this study were to assess the three-dimensional (3D) treatment changes (palatal surface area and volume) of forced unilateral posterior crossbite correction using either quad-helix or removable expansion plate appliances in the mixed dentition, and to compare the treatment changes with the three-dimensional changes occurring in age-matched untreated unilateral posterior crossbite patients as well as in subjects with normal occlusion and with no or mild orthodontic treatment need.
TRIAL DESIGN


Six-arm parallel group multicentre randomized controlled trial.
MATERIALS AND METHODS


One-hundred and thirty-five patients with unilateral posterior crossbite with functional shift were recruited. The patients were randomized by an independent person not involved in the trial. The randomization used blocks of 25, and the patients were randomized into the following five groups: quad-helix treatments in specialist orthodontic clinics (QHS), quad-helix treatments in general dentistry (QHG), removable expansion plate treatments in specialist orthodontic clinics (EPS), removable expansion plate treatments in general dentistry (EPG), and untreated crossbite (UC). Twenty-five patients with normal occlusion who served as normal controls were also included in the trial. Blinding of the outcome assessor and data analyst was accomplished. Data on all children were evaluated on an intention-to-treat basis, regarding 3D palatal surface area, palatal projection area, and palatal shell volume; two-dimensional linear measurements were registered at the same time.
RESULTS


After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG). QHS increased significantly more than EPG for the surface and projection area. The QHS and EPS had significantly higher mean difference for shell volume.
LIMITATIONS


The trial considers a short-term evaluation.
CONCLUSION


After treatment, there were no significant differences between the four treatment groups and the normal group, which implies that the surface and projection area together with the shell volume for the four treatment groups and the normal group were equivalent.
TRIAL REGISTRATION


The trial was registered with https://www.researchweb.org/is/sverige, registration number: 220751.",2020,"After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG).","['age-matched untreated unilateral posterior crossbite patients as well as in subjects with normal occlusion and with no or mild orthodontic treatment need', 'Twenty-five patients with normal occlusion who served as normal controls were also included in the trial', 'One-hundred and thirty-five patients with unilateral posterior crossbite with functional shift were recruited']","['quad-helix treatments in specialist orthodontic clinics (QHS), quad-helix treatments in general dentistry (QHG), removable expansion plate treatments in specialist orthodontic clinics (EPS), removable expansion plate treatments in general dentistry (EPG), and untreated crossbite (UC', 'three-dimensional (3D) treatment changes (palatal surface area and volume) of forced unilateral posterior crossbite correction using either quad-helix or removable expansion plate appliances', 'unilateral posterior crossbite correction']","['surface and projection area and shell volume', 'QHS']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0266059', 'cui_str': 'Posterior crossbite (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]","[{'cui': 'C4042790', 'cui_str': 'Quad'}, {'cui': 'C0018882', 'cui_str': 'Helix (Snails)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0242385', 'cui_str': 'Crossbite'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0266059', 'cui_str': 'Posterior crossbite (disorder)'}, {'cui': 'C0243112'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0033363', 'cui_str': 'Projection'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1275563', 'cui_str': 'qHS'}]",135.0,0.218393,"After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG).","[{'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Sollenius', 'Affiliation': 'Department of Orthodontics, County Council, Halland, Halmstad, Sweden.'}, {'ForeName': 'Aljaž', 'Initials': 'A', 'LastName': 'Golež', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Primožič', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Ovsenik', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bondemark', 'Affiliation': 'Department of Orthodontics, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Petrén', 'Affiliation': 'Department of Orthodontics, Malmö University, Malmö, Sweden.'}]",European journal of orthodontics,['10.1093/ejo/cjz054']
1106,32057371,Ticagrelor With or Without Aspirin After PCI: The TWILIGHT Platelet Substudy.,"BACKGROUND


An evolving strategy in the setting of percutaneous coronary intervention (PCI) involves withdrawal of acetylsalicylic acid (ASA), or aspirin, while maintaining P2Y 12  inhibition. However, the pharmacodynamic effects of this approach on blood thrombogenicity and platelet reactivity remain unknown.
OBJECTIVES


This study sought to compare the antithrombotic potency of ticagrelor alone versus ticagrelor plus ASA among high-risk patients undergoing PCI with drug-eluting stents.
METHODS


This was a mechanistic substudy within the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial, which randomized patients undergoing PCI to ticagrelor plus placebo versus ticagrelor plus ASA following 3 months of dual antiplatelet therapy. Substudy participants were enrolled after randomization, at which time ex vivo assays to quantify thrombus size under dynamic flow conditions and platelet reactivity were performed. Pharmacodynamic assessments were repeated 1 to 6 months thereafter. The primary endpoint was thrombus size at the post-randomization visit with platelet reactivity following stimuli to arachidonic acid, collagen, adenosine diphosphate, and thrombin as secondary endpoints. Results were analyzed using analysis of covariance.
RESULTS


A total of 51 patients were enrolled, among whom 42 underwent perfusion assays at baseline and follow-up with a median time between studies of 1.5 months. The adjusted mean difference in post-randomization thrombus area was similar between groups: -218.2 μm 2  (95% confidence interval [CI]: -575.9 to 139.9 μm 2 ; p = 0.22). Markers sensitive to cyclo-oxygenase-1 blockade, including platelet reactivity in response to arachidonic acid (mean difference: 10.9 U; 95% CI: 1.9 to 19.9 U) and collagen (mean difference: 9.8 U; 95% CI: 0.8 to 18.8 U) stimuli were higher among patients receiving placebo, whereas levels of platelet reactivity were similar with adenosine diphosphate and thrombin.
CONCLUSIONS


Among high-risk patients receiving drug-eluting stents, the antithrombotic potency of ticagrelor monotherapy is similar to that of ticagrelor plus ASA with respect to ex vivo blood thrombogenicity, whereas markers sensitive to cyclo-oxygenase-1 blockade are increased in the absence of ASA. (Platelet Substudy of the TWILIGHT Trial; NCT04001374).",2020,"Markers sensitive to cyclo-oxygenase-1 blockade, including platelet reactivity in response to arachidonic acid (mean difference: 10.9 U; 95% CI: 1.9 to 19.9 U) and collagen (mean difference: 9.8 U; 95% CI: 0.8 to 18.8 U) stimuli were higher among patients receiving placebo, whereas levels of platelet reactivity were similar with adenosine diphosphate and thrombin.
","['High-Risk Patients', 'A total of 51 patients were enrolled, among whom 42 underwent perfusion assays at baseline and follow-up with a median time between studies of 1.5\xa0months', 'high-risk patients receiving drug-eluting stents', 'high-risk patients undergoing PCI with drug-eluting stents']","['Ticagrelor With or Without Aspirin', 'ticagrelor', 'placebo', 'Ticagrelor With Aspirin', 'acetylsalicylic acid (ASA), or aspirin', 'TWILIGHT', 'ticagrelor plus ASA', 'PCI to ticagrelor plus placebo', 'percutaneous coronary intervention (PCI']","['levels of platelet reactivity', 'antithrombotic potency', 'blood thrombogenicity and platelet reactivity', 'thrombus size at the post-randomization visit with platelet reactivity following stimuli to arachidonic acid, collagen, adenosine diphosphate, and thrombin as secondary endpoints']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0005768'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",51.0,0.327655,"Markers sensitive to cyclo-oxygenase-1 blockade, including platelet reactivity in response to arachidonic acid (mean difference: 10.9 U; 95% CI: 1.9 to 19.9 U) and collagen (mean difference: 9.8 U; 95% CI: 0.8 to 18.8 U) stimuli were higher among patients receiving placebo, whereas levels of platelet reactivity were similar with adenosine diphosphate and thrombin.
","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'M Urooj', 'Initials': 'MU', 'LastName': 'Zafar', 'Affiliation': 'Atherothrombosis Research Unit, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ginés', 'Initials': 'G', 'LastName': 'Escolar', 'Affiliation': 'Atherothrombosis Research Unit, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.'}, {'ForeName': 'Samin K', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Annapoorna S', 'Initials': 'AS', 'LastName': 'Kini', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Joyce', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Vogel', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Farhan', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gurbel', 'Affiliation': 'Inova Center for Thrombosis Research and Translational Medicine, Falls Church, Virginia.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Badimon', 'Affiliation': 'Atherothrombosis Research Unit, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.11.056']
1107,31426869,Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men in China: a study protocol for a three-arm cluster randomized controlled trial.,"BACKGROUND


Gonorrhea and chlamydia testing rates are poor among Chinese men who have sex with men (MSM). A quasi-experimental study suggested that a pay-it-forward strategy increased dual gonorrhea/chlamydia testing among MSM. Pay-it-forward offers an individual a gift (e.g., a free test) and then asks the same person if they would like to give a gift to another person. This article reports the protocol of a randomized controlled trial to evaluate dual gonorrhea/chlamydia test uptake and other outcomes among MSM in three arms - a pay-it-forward arm, a pay-what-you-want arm, and a standard of care arm.
METHODS


Three hundred MSM will be recruited at three HIV testing sites in Guangzhou and Beijing. Testing sites include two hospital-based MSM sexually transmitted diseases clinics and one MSM community-based organization. Eligible participants will be born biologically male, aged 16 years or older, reporting previous anal sex with another man, having never participated in the pay-it-forward program, without previous gonorrhea and chlamydia testing in the past 12 months, and residing in China. Following a cluster randomized design, every cluster of ten participants will be randomly allocated into one of three arms: (1) a pay-it-forward arm in which men are offered free gonorrhea and chlamydia testing and then asked whether they would like to donate (""pay it forward"") toward testing for future testers; (2) a pay-what-you-want arm in which men are offered free testing and told to decide how much to pay after receiving the test; (3) a standard of care arm in which men can pay the full price for dual gonorrhoea and chlamydia testing. The primary outcome is dual gonorrhoea/chlamydia testing as verified by administrative records. Secondary outcomes include incremental cost per test, incremental cost per diagnosis, community connectedness, and social cohesion. Primary outcome will be calculated for each arm using intention-to-treat and compared using one-sided 95% confidence intervals with a margin of 20% increase defined as superiority.
DISCUSSION


This study will examine the pay-it-forward strategy in comparison to the standard of care in improving test uptake for gonorrhea and chlamydia. We will leverage the cluster randomized controlled trial to provide scientific evidence on the potential effect of pay-it-forward. Findings from this study will shed light on novel intervention methods for increasing preventive health service utilization and innovate ways to finance it among communities.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03741725 . Registered on 12 November 2018.",2019,A quasi-experimental study suggested that a pay-it-forward strategy increased dual gonorrhea/chlamydia testing among MSM.,"['Chinese men who have sex with men (MSM', 'men who have sex with men in China', 'Three hundred MSM will be recruited at three HIV testing sites in Guangzhou and Beijing', 'Eligible participants will be born biologically male, aged 16\u2009years or older, reporting previous anal sex with another man, having never participated in the pay-it-forward program, without previous gonorrhea and chlamydia testing in the past 12\u2009months, and residing in China']","['Pay-it-forward gonorrhea and chlamydia testing', 'pay-it-forward arm in which men are offered free gonorrhea and chlamydia testing and then asked whether they would like to donate (""pay it forward"") toward testing for future testers']","['dual gonorrhea/chlamydia testing', 'incremental cost per test, incremental cost per diagnosis, community connectedness, and social cohesion', 'dual gonorrhoea/chlamydia testing as verified by administrative records', 'calculated for each arm using intention-to-treat and compared using one-sided 95% confidence intervals with a margin of 20% increase defined as superiority']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]","[{'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",300.0,0.12104,A quasi-experimental study suggested that a pay-it-forward strategy increased dual gonorrhea/chlamydia testing among MSM.,"[{'ForeName': 'Tiange P', 'Initials': 'TP', 'LastName': 'Zhang', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Human Nature Lab, Department of Sociology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forastiere', 'Affiliation': 'Human Nature Lab, Department of Sociology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Human Nature Lab, Department of Sociology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Southern Medical University Dermatology Hospital, Guangzhou, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Mi', 'Affiliation': 'Blued, Beijing, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Weizan', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vickerman', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Southern Medical University Dermatology Hospital, Guangzhou, China.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Human Nature Lab, Department of Sociology, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China. jdtucker@med.unc.edu.'}]",Infectious diseases of poverty,['10.1186/s40249-019-0581-1']
1108,30996366,[Early functional recovery of direct anterior approach versus anterolateral approach for total hip arthroplasty].,"OBJECTIVE


To evaluate the early clinical effects of direct anterior approach (DAA) versus anterolateral approach (ALA) on safety and functional recovery following total hip arthroplasty (THA).
METHODS


Between January 2015 and May 2016, a randomized clinical trial was performed at Guizhou Provincial People's Hospital. A total of 50 patients who underwent THA were allocated for either the DAA (n=25) or ALA (n=25). DDA group had 25 patients (25 hips), including 16 males and 9 females, with the mean age of (62±2) years, BMI of (23.26 ±4.95) kg/m 2 (range: 19.6 to 29.5), and preoperative Harris score of (33.4 ±15.5) (range: 17.9 to 48.9). Eleven cases were diagnosed as primarily hip osteoarthritis, 4 were developmental dysplasia of the hip (DDH, Crowe 2) and 10 were hip avascular necrosis (AVN, Stages 3 to 4). ALA group had 25 patients (25 hips), including 18 males and 7 females, with the mean age of (59±3) years, BMI of (25.35 ±5.8) kg/m 2 (range: 18.2 to 29.8), and preoperative Harris score of (38.6 ± 16.7) (range: 23.1 to 56.5). Ten cases were diagnosed as primarily hip osteoarthritis, 3 were developmental dysplasia of the hip (DDH, Crowe 2) and 12 were hip avascular necrosis (AVN, Stages 3 to 4). Operation time, incision length, intra-operative blood loss and functional recovery of hip postoperatively were compared between the two groups.
RESULTS


The surgical incision of both groups were stage I healing. The mean follow-up was 6 months. There was no significant difference regarding operation time, incision length, and intra-operative blood loss between the two groups. However, we also found that there was no significant difference in the Harris score 3 months and 6 months postoperatively. In addition, two patients in ALA group suffered claudication (physical examination: abduction dysfunction of hip). We also found that DAA group resulted in better recovery of abductor strength and gait than ALA group during early follow-up.
CONCLUSION


Both DAA and ALA could obtain good results of early curative effect following THA. Moreover, DAA resulted in better gait than ALA during early follow-up.",2019,"Operation time, incision length, intra-operative blood loss and functional recovery of hip postoperatively were compared between the two groups.
","['total hip arthroplasty (THA', '50 patients who underwent THA', ""Between January 2015 and May 2016, a randomized clinical trial was performed at Guizhou Provincial People's Hospital"", 'Eleven cases were diagnosed as primarily hip osteoarthritis, 4 were developmental dysplasia of the hip (DDH, Crowe 2) and 10 were hip avascular necrosis (AVN, Stages 3 to 4', 'Ten cases were diagnosed as primarily hip osteoarthritis, 3 were developmental dysplasia of the hip (DDH, Crowe 2) and 12 were hip avascular necrosis (AVN, Stages 3 to 4', 'group had 25 patients (25 hips), including 18 males and 7 females, with the mean age of (59±3) years, BMI of (25.35 ±5.8) kg/m 2 (range: 18.2 to 29.8), and preoperative Harris score of (38.6 ± 16.7) (range: 23.1 to 56.5', 'group had 25 patients (25 hips), including 16 males and 9 females, with the mean age of (62±2) years, BMI of (23.26 ±4.95) kg/m 2 (range: 19.6 to 29.5), and preoperative Harris score of (33.4 ±15.5) (range: 17.9 to 48.9', 'total hip arthroplasty']","['ALA', 'direct anterior approach (DAA) versus anterolateral approach (ALA', 'direct anterior approach versus anterolateral approach', 'DDA', 'DAA']","['suffered claudication (physical examination: abduction dysfunction of hip', 'operation time, incision length, and intra-operative blood loss', 'safety and functional recovery', 'Operation time, incision length, intra-operative blood loss and functional recovery of hip postoperatively', 'recovery of abductor strength and gait']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0029410', 'cui_str': 'Coxarthrosis'}, {'cui': 'C4551649', 'cui_str': 'Congenital Dysplasia Of The Hip'}, {'cui': 'C0303135', 'cui_str': '10Be radioisotope'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C3887513', 'cui_str': 'Avascular necrosis (morphologic abnormality)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0106487', 'cui_str': 'DDA'}]","[{'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",11.0,0.030365,"Operation time, incision length, intra-operative blood loss and functional recovery of hip postoperatively were compared between the two groups.
","[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics, Guizhou Provincial people's Hospital, Guiyang 550002, China.""}, {'ForeName': 'X T', 'Initials': 'XT', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics, Guizhou Provincial people's Hospital, Guiyang 550002, China.""}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Tian', 'Affiliation': ""Department of Orthopaedics, Guizhou Provincial people's Hospital, Guiyang 550002, China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedics, Guizhou Provincial people's Hospital, Guiyang 550002, China.""}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
1109,31421395,"Daidzein and genistein have differential effects in decreasing whole body bone mineral density but had no effect on hip and spine density in premenopausal women: A 2-year randomized, double-blind, placebo-controlled study.","Soy isoflavones are potentially beneficial phytoestrogens, but their tissue-selective effects in women are poorly understood. We tested the hypothesis that soy isoflavones affect bone mineral density (BMD), which may be influenced by individual differences in isoflavone metabolism and serum calcium levels. Ninety-nine healthy premenopausal women were randomized to isoflavones (136.6 mg aglycone equivalence) and 98 to placebo for 5 days per week for up to 2 years. BMD, serum calcium, and urinary excretion of daidzein and genistein were measured before and during treatment. In 129 adherent subjects, we found that isoflavone exposure, determined by urinary excretion levels, but not by dose assignment, interacted with serum calcium in affecting whole body BMD, but not hip and spine BMD. The regression coefficient was -0.042 for genistein excretion (GE) and 0.091 for the interaction between GE and serum calcium (all P < .05). Daidzein excretion had similar but marginal effect. Genistein significantly decreased whole body BMD only at low normal serum calcium levels but increased whole body BMD at higher serum calcium levels. Comparing maximum to minimum GE, mean changes in whole body BMD were +0.033 and -0.113 g/cm 2  at serum calcium levels of 10 and 8.15 mg/dL, respectively. These associations were not evident by intention-to-treat analysis, which could not model for inter-individual differences in isoflavone metabolism. In summary, soy isoflavones decrease whole body BMD only when serum calcium is low. Isoflavones are dietary substances that may influence calcium homeostasis by releasing calcium from bone while sparing the common fracture risk sites hip and spine.",2019,Genistein significantly decreased whole body BMD only at low normal serum calcium levels but increased whole body BMD at higher serum calcium levels.,"['Ninety-nine healthy premenopausal women', 'premenopausal women', '129 adherent subjects']","['Daidzein and genistein', 'placebo', 'soy isoflavones', 'isoflavones', 'Isoflavones', 'Genistein', 'Soy isoflavones']","['whole body BMD', 'body BMD', 'whole body bone mineral density', 'bone mineral density (BMD', 'urinary excretion levels', 'BMD, serum calcium, and urinary excretion of daidzein and genistein', 'Daidzein excretion']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0057090', 'cui_str': 'diadzein'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone (substance)'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0057090', 'cui_str': 'diadzein'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}]",99.0,0.0742129,Genistein significantly decreased whole body BMD only at low normal serum calcium levels but increased whole body BMD at higher serum calcium levels.,"[{'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Nayeem', 'Affiliation': 'Department of Preventive Medicine and Community Health The University of Texas Medical Branch, Galveston, TX 77555. Electronic address: fanayeem@utmb.edu.'}, {'ForeName': 'Nai-Wei', 'Initials': 'NW', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine and Community Health The University of Texas Medical Branch, Galveston, TX 77555. Electronic address: Nai-Wei.Chen@beaumont.org.'}, {'ForeName': 'Manubai', 'Initials': 'M', 'LastName': 'Nagamani', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, TX 77555. Electronic address: mnagaman@gmail.com.'}, {'ForeName': 'Karl E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': 'Department of Preventive Medicine and Community Health The University of Texas Medical Branch, Galveston, TX 77555. Electronic address: kanderso@utmb.edu.'}, {'ForeName': 'Lee-Jane W', 'Initials': 'LW', 'LastName': 'Lu', 'Affiliation': 'Department of Preventive Medicine and Community Health The University of Texas Medical Branch, Galveston, TX 77555. Electronic address: llu@utmb.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.06.007']
1110,32040591,Endotoxin May Not Be the Major Cause of Postprandial Inflammation in Adults Who Consume a Single High-Fat or Moderately High-Fat Meal.,"BACKGROUND


Metabolic endotoxemia is considered a cause for high-fat diet (HFD)-induced inflammation. However, convincing experimental evidence in humans is scant.
OBJECTIVE


We determined whether a HFD or moderately HFD increases LPS and LPS-mediated cytokine production in the postprandial blood (PPB).
METHODS


Ninety-eight volunteers (age: 37.3 ± 1.5 y) from the cross-sectional phenotyping study (PS) and 62 volunteers (age: 26.8 ± 1.2 y) from the intervention study (IS) consumed a breakfast containing 60% kcal fat (HF) and 36% kcal fat (moderately HF), respectively. For the IS, only the results from the placebo group are presented. Blood samples were probed for LPS-mediated cytokine production by incubating them with LPS inhibitor polymyxin B (PMB) for 24 h at 37°C besides the Limulus amebocyte lysate (LAL) assay. Repeated-measures ANOVA was used to compare the temporal changes of metabolic profiles and treatment outcomes.
RESULTS


At least 87.5% of the plasma LPS measurements in 32 PS volunteers from each time point were below the LAL assay sensitivity (0.002 EU/mL). PMB suppressed IL-1β (P = 0.035) and IL-6 (P = 0.0487) production in the 3 h PPB of the PS after 24 h incubation at 37°C compared to the vehicle control, suggesting the presence of LPS. However, the amount of LPS did not increase the cytokine concentrations in the 3 h PPB above the fasting concentrations. Such suppression was not detected in the PPB of the IS. Treating whole blood with lipoprotein lipase (LPL) significantly (P < 0.05) increased FFA and cytokine (IL-1β, IL-6, TNF-α) concentrations in both studies.
CONCLUSION


LPS may not be the major cause of postprandial inflammation in healthy adults consuming a moderately HF meal (36% kcal fat, similar to the typical American diet) or a HF meal (60% kcal fat). Plasma FFAs may modulate postprandial inflammation. The prevailing concept of HFD-induced metabolic endotoxemia requires careful re-evaluation. The PS was registered at clinicaltrials.gov as NCT02367287 and the IS as NCT02472171.",2020,PMB suppressed IL-1β,"['Adults Who Consume a Single High-Fat or Moderately High-Fat Meal', 'healthy adults', 'Ninety-eight volunteers (age: 37.3\xa0±\xa01.5 y) from the cross-sectional phenotyping study (PS) and 62 volunteers (age: 26.8\xa0±\xa01.2 y) from the intervention study (IS) consumed a']","['breakfast containing 60% kcal fat (HF) and 36% kcal fat (moderately HF', 'LPS', 'placebo', 'Endotoxin', 'LPS inhibitor polymyxin B (PMB']","['PMB suppressed IL-1β', 'FFA and cytokine (IL-1β, IL-6, TNF-α) concentrations', 'blood with lipoprotein lipase (LPL', 'LAL assay sensitivity', 'cytokine concentrations', 'IL-6', 'plasma LPS measurements']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032535', 'cui_str': 'Polymyxin B'}]","[{'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005768'}, {'cui': 'C0023816', 'cui_str': 'Diglyceride Lipase'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",32.0,0.0412286,PMB suppressed IL-1β,"[{'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Mo', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616, USA.'}, {'ForeName': 'Shurong', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616, USA.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Burnett', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rutledge', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University of California-Davis, One Shields Avenue, Davis, CA 95616, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Hwang', 'Affiliation': 'USDA-ARS Western Human Nutrition Research Center, 430 West Health Sciences Dr., Davis, CA 95616, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa003']
1111,31424375,The Impact of Working Memory Training on Cognitive Abilities in Older Adults: The Role of Cognitive Reserve.,"OBJECTIVES


The aims of this study were to determine whether Working Memory (WM) training improves the cognitive functioning of older adults and to determine the role of cognitive reserve in WM training.
METHODS


Twenty-one older adults, aged between 65 and 91 years were included in the study. Ten of them were in the experimental group and 11 in the passive control group. The experimental group underwent 15 training sessions of n-back training over a period of five weeks, whereas the control group remained passive. All participants (from the experimental and control group) were tested before the training, one week after the training, and three months after the training with Rey- Osterrieth/Taylor Complex Figure test (ROCF), Digit span, and TMT (part A and part B).
RESULTS AND CONCLUSION


Results of our study suggest that although the experimental group slightly improved their performance on the trained task, the progress was not statistically significant. There was also no statistically significant transfer of training effects onto tasks of visual-spatial and verbal memory, as well as those related to executive functioning. However, the study did identify a statistically significant correlation between cognitive reserve and certain tests performed at the final testing: tasks measuring executive functioning and spatial ability. Results also revealed that the group that showed improvement in the training task was significantly better in the ROCF test in comparison with the group that had not improved their performance on the N-back task. Thus, visual-spatial abilities (visual perception, construction, and memory) were more connected with success in WM training, than other measured cognitive abilities (e.g. verbal and numerical memory).",2020,"There was also no statistically significant transfer of training effects onto tasks of visual-spatial and verbal memory, as well as those related to executive functioning.","['older adults', 'Older Adults', 'Twenty-one older adults, aged between 65 and 91 years were included in the study']","['15 training sessions of n-back training', 'Working Memory Training', 'working memory (WM) training', 'training with Rey-Osterrieth/Taylor Complex Figure test (ROCF), Digit span and TMT (part A and part B']","['training task', 'cognitive abilities (e.g. verbal and numerical memory', 'cognitive functioning', 'Cognitive Abilities', 'visual-spatial abilities (visual perception, construction and memory', 'training effects onto tasks of visual-spatial and verbal memory', 'executive functioning and spatial ability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}, {'cui': 'C0042830', 'cui_str': 'Visual Perception'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",21.0,0.0175156,"There was also no statistically significant transfer of training effects onto tasks of visual-spatial and verbal memory, as well as those related to executive functioning.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mičič', 'Affiliation': 'Department of Psychology, Faculty of Arts, University of Maribor, Koroška cesta 160, 2000 Maribor, Slovenia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Horvat', 'Affiliation': 'Department of Psychology, Faculty of Arts, University of Maribor, Koroška cesta 160, 2000 Maribor, Slovenia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bakracevic', 'Affiliation': 'Department of Psychology, Faculty of Arts, University of Maribor, Koroška cesta 160, 2000 Maribor, Slovenia.'}]",Current aging science,['10.2174/1874609812666190819125542']
1112,32135005,Physiological Characteristics of Musical Theatre Performers and the Effect on Cardiorespiratory Demand Whilst Singing and Dancing.,"AIMS


Musical theatre (MT) combines acting, singing, and dancing within a performance. The purpose of the current study was two-fold: 1) to report on the cardiorespiratory fitness of pre-professional MT dancers, and 2) to examine the cardiorespiratory demand of singing whilst dancing.
METHODS


Twenty-one participants (16 females, 5 males; age 20±1.23 yrs; height 169.1±9.24 cm; weight 62.7±10.56) in their final year of pre-professional training volunteered for the study. All participants performed a maximal aerobic capacity test on a treadmill using a portable breath-by-breath gas analyser. Nine participants completed a 4-minute section from Chorus Line twice, singing and dancing and just dancing, in a randomised order whilst wearing the same portable gas analyser. Blood lactate was measured at the end of each trial.
RESULTS


Male participants had significantly greater peak oxygen consumption (M vs F, 67.6±2.30 vs 55.6±4.42 mL/kg/min, p<0.001) and anaerobic threshold (% of peak VO2) (54.6±4.04% vs 43.1±3.68%, p<0.001), whilst maximum heart rate and heart rate at anaerobic threshold were similar. The physiological demands of dancing vs singing + dancing were similar, with the exception of the singing + dancing trial having significantly reduced mean breathing frequency and increased lactate (p<0.01).
CONCLUSIONS


MT dancers' aerobic capacity is greater than that observed in other theatre-based dance genres. The observed breathing frequency and lactate differences in the Chorus Line trails could be due to singing reducing breathing frequency, thereby influencing cardiorespiratory recovery mechanics and subsequently blood lactate levels.",2020,"RESULTS


Male participants had significantly greater peak oxygen consumption (M vs F,","['Male participants', 'Twenty-one participants (16 females, 5 males; age 20±1.23 yrs; height 169.1±9.24 cm; weight 62.7±10.56) in their final year of pre-professional training volunteered for the study']",['maximal aerobic capacity test on a treadmill using a portable breath-by-breath gas analyser'],"['peak oxygen consumption', 'blood lactate levels', 'mean breathing frequency and increased lactate (p<0.01', 'maximum heart rate and heart rate', 'Blood lactate']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0475251', 'cui_str': 'Gas analyzer (physical object)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",21.0,0.070649,"RESULTS


Male participants had significantly greater peak oxygen consumption (M vs F,","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Stephens', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wyon', 'Affiliation': 'Institute of Human Sciences, University of Wolverhampton, Gorway Rd, Walsall, WS1 3BD, UK. Tel +44-1902-323144. m.wyon@wlv.ac.uk.'}]",Medical problems of performing artists,['10.21091/mppa.2020.1007']
1113,32438300,Efficacy of 4 wk of home enteral feeding supplementation after esophagectomy on immune function: A randomized controlled trial.,"OBJECTIVES


In recent years, home enteral nutrition (HEN) has been adopted as a feasible and safe form of nutrition for patients undergoing esophagectomy. The aim of this study was to compare the effects of 4 wk of HEN with standard enteral nutrition (SEN) on immune function, nutritional status, and survival in patients undergoing esophagectomy.
METHODS


A parallel-group, randomized, single-blind, clinical trial was conducted between April 1 and August 1, 2017. Eighty patients were enrolled in the study and 62 were eligible for analysis. An enteral feeding pump was used to infuse enteral nutrition via jejunostomy tube postoperatively. Patients in HEN group were instructed to independently administer jejunostomy feeds at home. Immune parameters and nutritional indicators were measured at preoperative day 7 and at postoperative day 30.
RESULTS


There were no significant differences in baseline characteristics between the two groups. The levels of immunoglobulin (Ig)A and IgG, which can reflect a patient's immune function, significantly increased in the HEN group compared with those in the SEN group (P = 0.042 and P = 0.003, respectively). Comparing the two groups, 2-y progression-free survival and overall survival had no significant differences in survival curves (P = 0.36 and P = 0.29, respectively).
CONCLUSION


Four weeks of HEN is a safe and feasible nutritional strategy to improve immune function and nutritional status after esophagectomy. Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.",2020,"Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.","['Eighty patients were enrolled in the study and 62 were eligible for analysis', 'patients undergoing esophagectomy']","['home enteral nutrition (HEN', 'SEN', 'HEN', 'home enteral feeding supplementation', 'HEN with standard enteral nutrition (SEN']","['2-y progression-free survival and overall survival', 'levels of immunoglobulin (Ig)A and IgG', 'survival curves', 'immune function and nutritional status', 'survival', 'immune function, nutritional status, and survival', 'Immune parameters and nutritional indicators', 'immune function']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",80.0,0.113342,"Although there was no significant difference in survival between the two groups, HEN could still be more effective and beneficial than SEN to patients with defective nutritional and immune status.","[{'ForeName': 'Xiao-Kun', 'Initials': 'XK', 'LastName': 'Li', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhuang-Zhuang', 'Initials': 'ZZ', 'LastName': 'Cong', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Sai-Guang', 'Initials': 'SG', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Jingling School of Clinical Medicine, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Kai-Chao', 'Initials': 'KC', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Jingling School of Clinical Medicine, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, School of Medicine, Southeast University, Nanjing, China; Department of Clinical Medicine, School of Medicine, Southeast University, Nanjing, China. Electronic address: dryishen@nju.edu.cn.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110787']
1114,32438401,Mycoprotein ingestion stimulates protein synthesis rates to a greater extent than milk protein in rested and exercised skeletal muscle of healthy young men: a randomized controlled trial.,"BACKGROUND


Mycoprotein is a fungal-derived sustainable protein-rich food source, and its ingestion results in systemic amino acid and leucine concentrations similar to that following milk protein ingestion.
OBJECTIVE


We assessed the mixed skeletal muscle protein synthetic response to the ingestion of a single bolus of mycoprotein compared with a leucine-matched bolus of milk protein, in rested and exercised muscle of resistance-trained young men.
METHODS


Twenty resistance-trained healthy young males (age: 22 ± 1 y, body mass: 82 ± 2 kg, BMI: 25 ± 1 kg·m-2) took part in a randomized, double-blind, parallel-group study. Participants received primed, continuous infusions of L-[ring-2H5]phenylalanine and ingested either 31 g (26.2 g protein: 2.5 g leucine) milk protein (MILK) or 70 g (31.5 g protein: 2.5 g leucine) mycoprotein (MYCO) following a bout of unilateral resistance-type exercise (contralateral leg acting as resting control). Blood and m. vastus lateralis muscle samples were collected before exercise and protein ingestion, and following a 4-h postprandial period to assess mixed muscle fractional protein synthetic rates (FSRs) and myocellular signaling in response to the protein beverages in resting and exercised muscle.
RESULTS


Mixed muscle FSRs increased following MILK ingestion (from 0.036 ± 0.008 to 0.052 ± 0.006%·h-1 in rested, and 0.035 ± 0.008 to 0.056 ± 0.005%·h-1 in exercised muscle; P <0.01) but to a greater extent following MYCO ingestion (from 0.025 ± 0.006 to 0.057 ± 0.004%·h-1 in rested, and 0.024 ± 0.007 to 0.072 ± 0.005%·h-1 in exercised muscle; P <0.0001) (treatment × time interaction effect; P <0.05). Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
CONCLUSIONS


The ingestion of a single bolus of mycoprotein stimulates resting and postexercise muscle protein synthesis rates, and to a greater extent than a leucine-matched bolus of milk protein, in resistance-trained young men. This trial was registered at clinicaltrials.gov as 660065600.",2020,"Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
","['resistance-trained young men', 'healthy young men', 'Twenty resistance-trained healthy young males (age: 22\xa0±\xa01 y, body mass: 82\xa0±\xa02 kg, BMI: 25\xa0±\xa01 kg·m-2']","['Mycoprotein ingestion', 'leucine) mycoprotein (MYCO) following a bout of unilateral resistance-type exercise (contralateral leg acting as resting control', 'L-[ring-2H5]phenylalanine and ingested either 31 g (26.2 g protein: 2.5 g leucine) milk protein (MILK) or 70 g', 'leucine-matched bolus of milk protein']","['MILK ingestion', 'postprandial rise in FSRs', 'Postprandial FSRs']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.118269,"Postprandial FSRs trended to be greater in MYCO compared with MILK (0.065 ± 0.004 compared with 0.054 ± 0.004%·h-1, respectively; P = 0.093) and the postprandial rise in FSRs was greater in MYCO compared with MILK (Delta 0.040 ± 0.006 compared with Delta 0.018 ± 0.005%·h-1, respectively; P <0.01).
","[{'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Mariana O C', 'Initials': 'MOC', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch & Shriners Hospital for Children, Galveston, TX, USA.'}, {'ForeName': 'Doaa R', 'Initials': 'DR', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch & Shriners Hospital for Children, Galveston, TX, USA.'}, {'ForeName': 'Thomas S O', 'Initials': 'TSO', 'LastName': 'Jameson', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Jackman', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Blackwell', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Tim J A', 'Initials': 'TJA', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd, Stokesly, North Yorkshire, UK.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, Heavitree Road, University of Exeter, Exeter, UK.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa092']
1115,32688225,Gender and racial/ethnic differences in physiologic responses in the Stimulant Reduction Intervention using Dosed Exercise Study.,"Exercise may be beneficial for individuals in substance use disorder (SUD) treatment given the higher rates of both medical and psychiatric comorbidity, namely mood and anxiety disorders, compared to the general population. Gender and/or racial/ethnic differences in health benefits and response to prescribed exercise have been reported and may have implications for designing exercise interventions in SUD programs.
METHOD


Data are from the National Drug Abuse Treatment Clinical Trials Network (NIDA/CTN) Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial. Gender differences across racial/ethnic groups in physiological responses and stimulant withdrawal severity across time were analyzed using linear mixed effects models.
RESULTS


Males completed significantly more exercise sessions than females and were more adherent to the prescribed exercise dose of 12 Kcal/Kg/Week. Controlling for age, race/ethnicity, treatment group and stimulant withdrawal severity, there was a significant gender by time interaction for body mass index (BMI) (p < 0.001), waist circumference (p < 0.001) and heart rate measured prior to exercise sessions (p < 0.01). For females, body mass index (BMI) and waist circumference increased over time while for males BMI and waist circumference stayed unchanged or slightly decreased with time. Heart rate over time significantly increased for females at a higher rate than in males. Stimulant withdrawal severity was similar in males and females at baseline but males exhibited a significant decrease over time while females did not. Although baseline differences were observed, there were no time by race/ethnicity differences in physiologic responses.
DISCUSSION


Gender differences in response to exercise may have implications for developing gender specific exercise interventions in SUD programs.",2020,Stimulant withdrawal severity was similar in males and females at baseline but males exhibited a significant decrease over time while females did not.,['Data are from the National Drug Abuse Treatment Clinical Trials Network (NIDA/CTN'],['Stimulant Reduction Intervention'],"['waist circumference', 'heart rate', 'time interaction for body mass index (BMI', 'Heart rate over time', 'Stimulant withdrawal severity', 'body mass index (BMI) and waist circumference', 'exercise sessions']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1997739', 'cui_str': 'Psychostimulant withdrawal'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0431347,Stimulant withdrawal severity was similar in males and females at baseline but males exhibited a significant decrease over time while females did not.,"[{'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Killeen', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wolf', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Greer', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Rethorst', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106546']
1116,31416765,Cost Analysis of Pneumatic Retinopexy versus Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment.,"PURPOSE


To perform a cost-utility analysis and comparison between pneumatic retinopexy (PR) and pars plana vitrectomy (PPV) for primary rhegmatogenous retinal detachment (RRD) repair.
DESIGN


A cost-utility analysis using decision analysis.
PARTICIPANTS


There were no participants.
METHODS


A decision analysis model was constructed based on results from the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial to calculate the costs, lifetime usefulness, and lifetime cost per quality-adjusted life year (QALY) for the treatment of RRD with PR or PPV. Data from the Centers for Medicare and Medicaid Services were used to calculate the associated adjusted costs in facility and nonfacility practice settings.
MAIN OUTCOME MEASURES


Cost of intervention, utility gain over natural history, QALY gained, and cost per QALY.
RESULTS


The total imputed costs (all in 2019 United States dollars) for primary repair of RRD in facility and nonfacility settings were $4451 and $2456, respectively, in the PR group and $7108 and $4514, respectively, in the PPV group. The estimated lifetime QALYs gained were 5.9 and 5.4 in the PR and PPV groups, respectively. The cost per QALY for facility and nonfacility settings was $751 and $414, respectively, in the PR group and $1312 and $833, respectively, in the PPV group.
CONCLUSIONS


Cost-utility analysis of both PR and PPV demonstrated excellent results for both methods for RRD repair, with the metrics for PR somewhat more favorable independent of the practice settings (facility or nonfacility based).",2019,"The cost per QALY for facility and nonfacility settings was $751 and $414, respectively, in the PR group and $1312 and $833, respectively, in the PPV group.
","['primary rhegmatogenous retinal detachment (RRD) repair', 'Rhegmatogenous Retinal Detachment']","['pneumatic retinopexy (PR) and pars plana vitrectomy (PPV', 'Pneumatic Retinopexy versus Vitrectomy', 'Pneumatic Retinopexy versus Pars Plana Vitrectomy']","['total imputed costs', 'costs, lifetime usefulness, and lifetime cost per quality-adjusted life year (QALY', 'Cost of intervention, utility gain over natural history, QALY gained, and cost per QALY', 'cost per QALY for facility and nonfacility settings', 'estimated lifetime QALYs gained']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy (procedure)'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach (procedure)'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0362475,"The cost per QALY for facility and nonfacility settings was $751 and $414, respectively, in the PR group and $1312 and $833, respectively, in the PPV group.
","[{'ForeName': 'Abdelrahman M', 'Initials': 'AM', 'LastName': 'Elhusseiny', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; Department of Ophthalmology, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Yannuzzi', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Smiddy', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: wsmiddy@med.miami.edu.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.06.003']
1117,31983031,Rapid changes in neuroendocrine regulation may contribute to reversal of type 2 diabetes after gastric bypass surgery.,"OBJECTIVE


To explore the role of hormones and the autonomic nervous system in the rapid remission of diabetes after Roux-en-Y Gastric Bypass (RYGB).
RESEARCH DESIGN AND METHODS


Nineteen obese patients with type 2 diabetes, 7 M/12 F, were randomized (2:1) to RYGB or standard-of-care medical treatment (control). At baseline and 4 and 24 weeks post surgery, fasting blood sampling, OGTT, intravenous arginine challenge, and heart-rate variability (HRV) assessments were performed.
RESULTS


At both 4 and 24 weeks post-RYGB the following effects were found: arginine-stimulated insulin secretion was reduced. GLP-1, GIP, and glucagon rise during OGTT was enhanced. IGF-1 and GH levels increased. In addition, total HRV and spectral components P LF  (power of low frequency) and P HF  (power of high frequency) increased. At 4 weeks, morning cortisol was lower than baseline and 24 weeks. At 24 weeks, NEFA levels during OGTT, and the P LF /P HF  ratio decreased. None of these changes were seen in the control group.
CONCLUSIONS


There were rapid changes within 4 weeks after RYGB: signs of enhanced parasympathetic nerve activity, reduced morning cortisol, and enhanced incretin and glucagon responses to glucose. The findings suggest that neurohormonal mechanisms can contribute to the rapid improvement of insulin resistance and glycemia following RYGB in type 2 diabetes.",2020,At both 4 and 24 weeks post-RYGB the following effects were found: arginine-stimulated insulin secretion was reduced.,"['Nineteen obese patients with type 2 diabetes, 7 M/12 F', 'diabetes after Roux-en-Y Gastric Bypass (RYGB']",['RYGB or standard-of-care medical treatment (control'],"['insulin resistance and glycemia', 'GLP-1, GIP, and glucagon rise', 'enhanced parasympathetic nerve activity, reduced morning cortisol, and enhanced incretin and glucagon responses to glucose', 'total HRV and spectral components P LF  (power of low frequency) and P HF', 'IGF-1 and GH levels', 'morning cortisol', 'NEFA levels', 'fasting blood sampling, OGTT, intravenous arginine challenge, and heart-rate variability (HRV) assessments', 'arginine-stimulated insulin secretion']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0459522', 'cui_str': 'Parasympathetic nerve'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",19.0,0.029435,At both 4 and 24 weeks post-RYGB the following effects were found: arginine-stimulated insulin secretion was reduced.,"[{'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Katsogiannos', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Prasad G', 'Initials': 'PG', 'LastName': 'Kamble', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Wiklund', 'Affiliation': 'Radiation Sciences, Biomedical Engineering & Informatics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sundbom', 'Affiliation': 'Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Espes', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Hammar', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'F Anders', 'Initials': 'FA', 'LastName': 'Karlsson', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Department of Medical Science, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden. jan.eriksson@medsci.uu.se.'}]",Endocrine,['10.1007/s12020-020-02203-w']
1118,32438267,Effect of exercise on knee joint contact forces in people following medial partial meniscectomy: A secondary analysis of a randomised controlled trial.,"BACKGROUND


Arthroscopic partial meniscectomy may cause knee osteoarthritis, which may be related to altered joint loading. Previous research has failed to demonstrate that exercise can reduce medial compartment knee loads following meniscectomy but has not considered muscular loading in their estimates.
RESEARCH QUESTION


What is the effect of exercise compared to no intervention on peak medial tibiofemoral joint contact force during walking using an electromyogram-driven neuromusculoskeletal model, following medial arthroscopic partial meniscectomy?
METHODS


This is a secondary analysis of a randomized controlled trial (RCT). 41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months, were randomly allocated to either a 12-week, home-based, physiotherapist-guided exercise program or to no exercise (control group). Three-dimensional lower-body motion, ground reaction forces, and surface electromyograms from eight lower-limb muscles were acquired during self-selected normal- and fast-paced walking at baseline and follow-up. An electromyogram-driven neuromusculoskeletal model estimated medial compartment contact forces (body weight). Linear regression models evaluated between-group differences (mean difference (95% CI)).
RESULTS


There were no significant between-group differences in the change (follow-up minus baseline) in first peak medial contact force during self-selected normal- or fast-paced walking (0.07 (-0.08 to 0.23), P = 0.34 and 0.01 (-0.19 to 0.22), P = 0.89 respectively). No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02 (-0.17 to 0.22), P = 0.81 respectively). At the individual level, variability was observed for changes in first (range -26.2% to +31.7%) and second (range -46.5% to +59.9%) peak tibiofemoral contact force.
SIGNIFICANCE


This is the first study to apply electromyogram-driven neuromusculoskeletal modelling to an exercise intervention in a RCT. While our results suggest that a 12-week exercise program does not alter peak medial knee loads after meniscectomy, within-participant variability suggests individual-specific muscle activation patterns that warrant further investigation.",2020,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","['41 participants aged between 30-50 years with medial arthroscopic partial meniscectomy within the past 3-12 months', 'people following medial partial meniscectomy']","['exercise intervention', 'physiotherapist-guided exercise program or to no exercise (control group', 'exercise']","['knee joint contact forces', 'peak medial knee loads', 'change in second peak medial contact force during normal- or fast-paced walking', 'peak tibiofemoral contact force', 'peak medial contact force during self-selected normal- or fast-paced walking']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",41.0,0.0930649,"No significant between-group difference was found for change in second peak medial contact force during normal- or fast-paced walking (0.09 (-0.09 to 0.28), P = 0.31 and 0.02","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Starkey', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Gavin K', 'Initials': 'GK', 'LastName': 'Lenton', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Saxby', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wrigley', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lloyd', 'Affiliation': 'Gold Coast Orthopaedics Research, Engineering and Education Alliance, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, University of Melbourne, Victoria, Australia. Electronic address: halm@unimelb.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.04.025']
1119,32140889,"Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy in patients with newly diagnosed malignant glioma.","Purpose Galunisertib, a TGF-β inhibitor, has demonstrated antitumor effects in preclinical and radiographic responses in some patients with malignant glioma. This Phase 1b/2a trial investigated the clinical benefit of combining galunisertib with temozolomide-based radiochemotherapy (TMZ/RTX) in patients with newly diagnosed malignant glioma (NCT01220271). Methods This is an open-label, 2-arm Phase 1b/2a study (N = 56) of galunisertib (intermittent dosing: 14 days on/14 days off per cycle of 28 days) in combination with TMZ/RTX (n = 40), versus a control arm (TMZ/RTX, n = 16). The primary objective of Phase 1b was to determine the safe and tolerable Phase 2 dose of galunisertib. The primary objective of Phase 2a was to confirm the tolerability and pharmacodynamic profile of galunisertib with TMZ/RTX, and the secondary objectives included determining the efficacy and pharmacokinetic (PK) profile of galunisertib with TMZ/RTX in patients with glioblastoma. This study also characterized the changes in the major T-cell subsets during TMZ/RTX plus galunisertib treatment. Results In the Phase 2a study, efficacy results for patients treated with galunisertib plus TMZ/RTX or TMZ/RTX were: median overall survival (18.2 vs 17.9 months), median progression-free survival (7.6 vs 11.5 months), and disease control rate (80% [32/40] vs 56% [9/16] patients) respectively. PK profile of galunisertib plus TMZ/RTX regimen was consistent with previously published PK data of galunisertib. The overall safety profile across treatment arms was comparable. Conclusion No differences in efficacy, safety or pharmacokinetic variables were observed between the two treatment arms.",2020,"No differences in efficacy, safety or pharmacokinetic variables were observed between the two treatment arms.","['patients with malignant glioma', 'patients with glioblastoma', 'patients with newly diagnosed malignant glioma', 'patients with newly diagnosed malignant glioma (NCT01220271']","['galunisertib plus TMZ/RTX or TMZ/RTX', 'temozolomide-based radiochemotherapy (TMZ/RTX', 'TMZ/RTX', 'standard temozolomide-based radiochemotherapy', 'galunisertib plus TMZ/RTX']","['efficacy and pharmacokinetic (PK) profile', 'median overall survival', 'median progression-free survival', 'overall safety profile', 'efficacy, safety or pharmacokinetic variables', 'disease control rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555198', 'cui_str': 'Malignant Glioma'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}]","[{'cui': 'C3896943'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0976929,"No differences in efficacy, safety or pharmacokinetic variables were observed between the two treatment arms.","[{'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'Clinical Cooperation Unit Neuro-oncology, German Cancer Research Center, Heidelberg University Medical Center, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. antje.wick@med.uni-heidelberg.de.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Desjardins', 'Affiliation': 'The Preston Robert Tisch Brain Tumor Center at Duke, Duke University, Durham, NC, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suarez', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Forsyth', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Ivelina', 'Initials': 'I', 'LastName': 'Gueorguieva', 'Affiliation': 'Eli Lilly and Company, Erl Wood, UK.'}, {'ForeName': 'Tiana', 'Initials': 'T', 'LastName': 'Burkholder', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Ann Louise', 'Initials': 'AL', 'LastName': 'Cleverly', 'Affiliation': 'Eli Lilly and Company, Erl Wood, UK.'}, {'ForeName': 'Shawn T', 'Initials': 'ST', 'LastName': 'Estrem', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Shuaicheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'BioStat Solutions, Inc, Frederick, MD, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Lahn', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Guba', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Capper', 'Affiliation': 'Department of Neuropathology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rodon', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain.""}]",Investigational new drugs,['10.1007/s10637-020-00910-9']
1120,32134290,Online programs improve relationship functioning for distressed low-income couples: Results from a nationwide randomized controlled trial.,"OBJECTIVE


Although low-income couples experience greater relationship challenges, they have limited access to effective relationship interventions. Furthermore, most previous efforts to improve low-income couples' relationships have yielded very small effects (Hawkins & Erickson, 2015). In an effort to overcome these limitations, this study investigated the effectiveness of 2 web-based interventions for low-income couples.
METHOD


In total, 742 low-income couples ( N  = 1,484 individuals; mean [ M ] age = 33; 55% White, non-Hispanic; 52% married; median [ Mdn ] annual household income = $27,000) were recruited nationally and randomized to the OurRelationship program, the ePREP program, or a waitlist control group. Couples were repeatedly assessed for 6 months using self-report measures of relationship satisfaction, communication conflict, intimate partner violence, emotional support, and breakup potential. Relationship status was assessed at 6-month follow-up.
RESULTS


Compared to the control group, intervention couples experienced significantly greater improvements in all 5 domains of relationship functioning ( Mdn  | d | = 0.46) by the end of the program; these effects were maintained in the 4 months after treatment. However, neither program significantly reduced the frequency of breakups by the 6-month follow-up. Differences between couples in the two interventions were minimal ( Mdn  Cohen's | d | = 0.11); however, couples in the OurRelationship program experienced significantly greater decreases in conflict ( d  = 0.24).
CONCLUSIONS


The results indicate that brief, web-based interventions can serve a central role in delivering effective services to low-income couples. Additionally, the general equivalence of the two interventions indicates that both communication-focused and problem-focused interventions can be successful in improving the relationship functioning of low-income couples. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to the control group, intervention couples experienced significantly greater improvements in all 5 domains of relationship functioning ( Mdn  | d | = 0.46) by the end of the program; these effects were maintained in the 4 months after treatment.","['742 low-income couples ( N  ', '1,484 individuals; mean [ M ] age = 33; 55% White, non-Hispanic; 52% married; median [ Mdn ] annual household income = $27,000', 'low-income couples', 'distressed low-income couples']","['OurRelationship program, the ePREP program, or a waitlist control group', 'Online programs']","['frequency of breakups', 'relationship functioning', 'conflict', 'relationship satisfaction, communication conflict, intimate partner violence, emotional support, and breakup potential']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0557163', 'cui_str': 'Household income (observable entity)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}]",27000.0,0.039385,"Compared to the control group, intervention couples experienced significantly greater improvements in all 5 domains of relationship functioning ( Mdn  | d | = 0.46) by the end of the program; these effects were maintained in the 4 months after treatment.","[{'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Doss', 'Affiliation': 'Department of Psychology, University of Miami.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Knopp', 'Affiliation': 'Department of Psychology, University of Denver.'}, {'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Department of Psychology, University of Miami.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rothman', 'Affiliation': 'Department of Psychology, University of Miami.'}, {'ForeName': 'S Gabe', 'Initials': 'SG', 'LastName': 'Hatch', 'Affiliation': 'Department of Psychology, University of Miami.'}, {'ForeName': 'Galena K', 'Initials': 'GK', 'LastName': 'Rhoades', 'Affiliation': 'Department of Psychology, University of Denver.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000479']
1121,32134291,A randomized clinical trial of mindfulness-based cognitive therapy for women with irritable bowel syndrome-Effects and mechanisms.,"OBJECTIVE


Irritable bowel syndrome (IBS) is a chronic disorder of brain-gut interaction. Previous studies suggest that mindfulness could be therapeutic for IBS patients, however no study has evaluated the effects of mindfulness-based cognitive therapy adapted for patients with IBS (MBCT-IBS). A 6-week MBCT-IBS course was designed to reduce symptoms and increase quality of life. This study aimed to evaluate the effects of MBCT-IBS and to investigate its therapeutic mechanisms in a randomized controlled trial.
METHOD


Sixty-seven female patients with IBS were randomized to MBCT-IBS (MG;  n  = 36) or a waitlist (WL;  n  = 31) control condition. Patients completed standardized self-report measures of IBS symptom severity, IBS quality of life, maladaptive illness cognitions (catastrophizing, visceral anxiety sensitivity) and mindfulness at baseline, after 2 treatment sessions, at posttreatment, and at 6-week follow-up. Self-referential processing of illness and health was measured with an implicit association test (IAT).
RESULTS


The MG reported significantly greater reductions in IBS symptoms ( p  = .003) and improvements in quality of life ( p  < .001) at follow-up compared with the WL. Changes in visceral anxiety sensitivity and pain catastrophizing at posttreatment and reductions in the IAT-score after 2 sessions combined with increases in nonjudgmental awareness at posttreatment mediated reductions in IBS symptoms.
CONCLUSIONS


MBCT-IBS has the potential to reduce IBS symptoms and increase quality of life. MBCT-IBS may exert its effect on IBS symptoms via reducing maladaptive illness cognitions and activating changes in self-processing (reducing biases in self-referent processing of illness and health and increasing nonjudgmental awareness). (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,The MG reported significantly greater reductions in IBS symptoms ( p  = .003) and improvements in quality of life ( p  < .001) at follow-up compared with the WL.,"['women with irritable bowel syndrome-Effects and mechanisms', 'patients with IBS (MBCT-IBS', 'Sixty-seven female patients with IBS']","['mindfulness-based cognitive therapy', 'MBCT-IBS', 'MBCT-IBS (MG;  n  = 36) or a waitlist (WL;  n  = 31) control condition']","['symptoms and increase quality of life', 'nonjudgmental awareness', 'implicit association test (IAT', 'quality of life', 'IBS symptoms', 'IBS symptoms and increase quality of life', 'visceral anxiety sensitivity and pain catastrophizing', 'IBS symptom severity, IBS quality of life, maladaptive illness cognitions (catastrophizing, visceral anxiety sensitivity) and mindfulness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",67.0,0.0639571,The MG reported significantly greater reductions in IBS symptoms ( p  = .003) and improvements in quality of life ( p  < .001) at follow-up compared with the WL.,"[{'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Henrich', 'Affiliation': 'Unit of Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Social and Behavioural Sciences, Leiden University.'}, {'ForeName': 'Bergljot', 'Initials': 'B', 'LastName': 'Gjelsvik', 'Affiliation': 'Department of Psychiatry, University of Oxford.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Surawy', 'Affiliation': 'Department of Psychiatry, University of Oxford.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'Oxford Psychological Medicine Centre, Oxford University Hospitals NHS Foundation Trust.'}, {'ForeName': 'Maryanne', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Department of Experimental Psychology, University of Oxford.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000483']
1122,32438301,Preoperative fasting abbreviation (Enhanced Recovery After Surgery protocol) and effects on the metabolism of patients undergoing gynecological surgeries under spinal anesthesia: A randomized clinical trial.,"OBJECTIVES


Recommended perioperative nutritional interventions may contribute to satisfactory surgical outcomes. Each moment in the course of a surgical pathologic condition may be a window of opportunity for an intervention with a positive impact on postoperative recovery. Based on the idea of accelerating postoperative recovery, the objective of this study was to evaluate the effectiveness of a nutritional intervention with preoperative fasting abbreviation (Enhanced Recovery After Surgery recommendations) on the metabolism of patients undergoing gynecologic surgeries under spinal anesthesia.
METHODS


This randomized clinical trial was performed at a hospital of medium complexity. After Human Research Ethics Committee approval on August 24, 2015, 80 women who had gynecologic surgery in the period from January to June 2016 and signed the consent form were randomly allocated into two groups: a control group (n = 42) and a juice group (n = 38). They received 200 mL of inert solution (control group) or liquid enriched with carbohydrate and protein (juice group) 4 h before surgery. The variables studied were serum glucose, insulin, insulin resistance evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR), C-reactive protein, and albumin in the pre- and postoperative periods. The statistical analysis was performed with SPSS 20.0.
RESULTS


There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
CONCLUSIONS


Preoperative fasting abbreviation with liquid containing carbohydrate and protein before gynecologic surgeries may provide metabolic stability with lower variation in insulin resistance than inert solution.",2020,"There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
","['80 women who had gynecologic surgery in the period from January to June 2016 and signed the consent', 'patients undergoing gynecologic surgeries under spinal anesthesia']",['200 mL of inert solution (control group) or liquid enriched with carbohydrate and protein (juice group) 4 h before surgery'],"['serum glucose, insulin, insulin resistance evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR), C-reactive protein, and albumin in the pre- and postoperative periods', 'Preoperative fasting abbreviation', 'HOMA-IR index']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0703072,"There was a statistically significant difference in the coefficient of variation for the HOMA-IR index in the control group (17.27%; P < 0.01) compared with the juice group (8.46%; P < 0.05), which remained stable from the pre- to the postoperative period.
","[{'ForeName': 'Gisele Vissoci', 'Initials': 'GV', 'LastName': 'Marquini', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil. Electronic address: giselemarquini@gmail.com.'}, {'ForeName': 'Francisco Edes', 'Initials': 'FE', 'LastName': 'da Silva Pinheiro', 'Affiliation': 'Hospital and Municipal Maternity Dr. Odelmo Leão Carneiro, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Alfredo Urbano', 'Initials': 'AU', 'LastName': 'da Costa Vieira', 'Affiliation': 'Hospital and Municipal Maternity Dr. Odelmo Leão Carneiro, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Rogério Melo', 'Initials': 'RM', 'LastName': 'da Costa Pinto', 'Affiliation': 'Faculty of Maths, Nucleus of Statistical and Biometrical Studies, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Maria Gabriela Baumgarten', 'Initials': 'MGB', 'LastName': 'Kuster Uyeda', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel João Batista Castello', 'Initials': 'MJBC', 'LastName': 'Girão', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marair Gracio Ferreira', 'Initials': 'MGF', 'LastName': 'Sartori', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, São Paulo, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110790']
1123,32103514,"Dexamethasone on postoperative gastrointestinal motility: A placebo-controlled, double-blinded, randomized controlled trial.","BACKGROUND AND AIM


Following abdominal surgery, patients usually experience a transient episode of impaired gastrointestinal motility. This study aimed to determine whether a single preoperative dose of dexamethasone can promote the recovery of gastrointestinal function in patients following elective gastrointestinal surgery.
METHODS


In this single-center, two-arm, parallel, randomized controlled trial, we studied 126 patients (aged 18-80 years) who underwent elective open or laparoscopic bowel surgery for malignant or benign pathology. At the induction of anesthesia, a treatment group (n = 64) received a single dose of 8-mg intravenous dexamethasone, and a control group (n = 62) received normal saline.
RESULTS


Intravenous administration of 8-mg dexamethasone significantly decreased the time to return of flatus by an average of approximately 8 h (P < 0.05). Abdominal distension was significantly reduced on the third day after surgery in the dexamethasone group (P < 0.05), and the time to tolerance of a liquid diet was shorter in the dexamethasone group (P < 0.01). There were no significant differences in other secondary outcomes, including postoperative pain, complication rates, length of hospital stay, or time to first defecation, between the two groups.
CONCLUSIONS


A single intravenous dose of 8-mg dexamethasone at induction of anesthesia significantly decreases the time to return of flatus, improves abdominal distension at 72 h, and promotes tolerance of a liquid diet. Although further studies are required to confirm our results, we recommend that dexamethasone should be used more widely in gastrointestinal surgery.",2020,Abdominal distension was significantly reduced on the third day after surgery in the dexamethasone group (p<0.05) and the time to tolerance of a liquid diet was shorter in the dexamethasone group (p<0.01).,"['for malignant or benign pathology', '126 patients (aged 18-80 years) who underwent', 'patients following elective gastrointestinal surgery']","['Dexamethasone', 'placebo', 'dexamethasone', 'elective open or laparoscopic bowel surgery', 'normal saline']","['time to return of flatus', 'postoperative pain, complication rates, length of hospital stay, or time to first defecation', 'Abdominal distension', 'time to return of flatus, improves abdominal distension', 'time to tolerance of a liquid diet', 'postoperative gastrointestinal motility']","[{'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}]",126.0,0.420909,Abdominal distension was significantly reduced on the third day after surgery in the dexamethasone group (p<0.05) and the time to tolerance of a liquid diet was shorter in the dexamethasone group (p<0.01).,"[{'ForeName': 'Yuezhi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Chenyang', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Lian', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Yuehan', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Wenhai', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Changkun', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Leping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Jing', 'Affiliation': 'Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15020']
1124,31944804,"Use of common and unique techniques in the early treatment phase for cognitive-behavioral, interpersonal/emotional, and supportive listening interventions for generalized anxiety disorder.","Psychotherapy research often compares specific treatments to control conditions to establish efficacy of the specified treatment. Research has typically evaluated common factor elements (e.g., credibility, expectancy) in treatments only after the first or second session, largely as a manipulation check and under the assumption that such factors are static. This study observed therapist common factor and model-specific interventions in three treatment approaches from a randomized control trial for generalized anxiety disorder across the entire early phase of treatment (i.e., first five sessions). The parent randomized control trial compared two treatment conditions, using an additive design where patients were randomized to receive either interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy. The first five video-recorded sessions of  N  = 40 randomly sampled participants were observationally coded with a multidimensional intervention measure, with subscales reflecting diverse theoretical orientations and common factors. Multilevel modeling was used to examine intervention use and investigate differences between treatment conditions and segments. Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening. The pattern of intervention use of other subscales was generally consistent with the orientation of the respective protocols. In the early phase of treatment, supportive listening conditions do not appear to function as common factor controls in the manner that many might assume. Common factors are potentially enhanced in bona fide treatments that include a more detailed, specific rationale and clear and cohesive techniques and goals. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.",['generalized anxiety disorder'],"['therapist common factor and model-specific interventions', 'interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy']",[],"[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],2020.0,0.0256031,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.","[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Schwartzman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kyler', 'Initials': 'K', 'LastName': 'Lehrbach', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Louis G', 'Initials': 'LG', 'LastName': 'Castonguay', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000277']
1125,31359782,A Randomized Crossover Study to Evaluate Recipe Acceptability in Breastfeeding Mothers and Young Children in India Targeted for a Multiple Biofortified Food Crop Intervention.,"BACKGROUND


A multiple biofortified food crop trial targeting iron, zinc, and vitamin A deficiencies among young children and their breastfeeding mothers is planned in India.
OBJECTIVE


To determine the acceptability of recipes prepared with control and biofortified pearl millet, wheat, lentils, and sweet potato.
METHODS


Children (6-24 months) and their mothers were enrolled as pairs (n = 52). Weight and height/length were determined. Mothers and children were separately, individually randomized in a crossover design to control or biofortified recipes. Children's 3-day intake was measured per recipe and crop variety. For mothers, a 9-point hedonic scale evaluated color, odor, taste, and overall acceptability.
RESULTS


Children's mean (SD) length-/height-for-age  Z -score was -1.2 (1.7), with 27% < -2 (stunted). Mean weight-for-length  Z -score was -0.6 (1.2) with 9.6% < -2 (wasted). Mother's body mass index showed 17% <18.5 and 38% >25. There was no difference in the children's intake of biofortified versus control varieties of any recipe ( P  ≥ .22); overall median daily intake was 75 g (Q1: 61, Q3: 100). Mother's hedonic scores for color, odor, taste, or overall acceptability did not demonstrate any notable differences ( P  ≥ .23 for overall acceptability); combined median overall acceptability score was 8.5 (Q1: 8.0, Q3: 9.0).
CONCLUSIONS


Recipes were consumed readily, were rated as highly acceptable, and did not show any differences between biofortified and control varieties.",2019,"There was no difference in the children's intake of biofortified versus control varieties of any recipe ( P  ≥ .22); overall median daily intake was 75 g (Q1: 61, Q3: 100).","['Breastfeeding Mothers and Young Children in India', 'Mothers and children', 'Children (6-24 months) and their mothers were enrolled as pairs (n = 52', 'young children and their breastfeeding mothers']","['control or biofortified recipes', 'recipes prepared with control and biofortified pearl millet, wheat, lentils, and sweet potato']","['Weight and height/length', 'Mean weight-for-length  Z -score', '9-point hedonic scale evaluated color, odor, taste, and overall acceptability', 'overall acceptability); combined median overall acceptability score', ""Children's mean (SD) length-/height-for-age  Z -score"", ""Mother's hedonic scores for color, odor, taste, or overall acceptability"", ""Children's 3-day intake""]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0331550', 'cui_str': 'Millet, Pearl'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0331252', 'cui_str': 'Ipomoea batatas'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0222045'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.131924,"There was no difference in the children's intake of biofortified versus control varieties of any recipe ( P  ≥ .22); overall median daily intake was 75 g (Q1: 61, Q3: 100).","[{'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Gannon', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Thakker', 'Affiliation': ""SNDT Women's University, Mumbai, Maharashtra, India.""}, {'ForeName': 'Vincent S', 'Initials': 'VS', 'LastName': 'Bonam', 'Affiliation': 'Arogyavaram Medical Centre, Madanapalle, Andhra Pradesh, India.'}, {'ForeName': 'Jere D', 'Initials': 'JD', 'LastName': 'Haas', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Bonam', 'Affiliation': 'Arogyavaram Medical Centre, Madanapalle, Andhra Pradesh, India.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Finkelstein', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Shobha A', 'Initials': 'SA', 'LastName': 'Udipi', 'Affiliation': ""SNDT Women's University, Mumbai, Maharashtra, India.""}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Cornell University, Ithaca, NY, USA.'}]",Food and nutrition bulletin,['10.1177/0379572119855588']
1126,31945149,Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study.,"The phase 3 ECHELON-1 study demonstrated that brentuximab vedotin (A) with doxorubicin, vinblastine, and dacarbazine (AVD; A+AVD) exhibited superior modified progression-free survival (PFS) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for frontline treatment of patients with stage III/IV classical Hodgkin lymphoma (cHL). Maturing positron emission tomography (PET)-adapted trial data highlight potential limitations of PET-adapted approaches, including toxicities with dose intensification and higher-than-expected relapse rates in PET scan after cycle 2 (PET2)-negative (PET2-) patients. We present an update of the ECHELON-1 study, including an exploratory analysis of 3-year PFS per investigator. A total of 1334 patients with stage III or IV cHL were randomized 1:1 to receive 6 cycles of A+AVD (n = 664) or ABVD (n = 670). Interim PET2 was required. At median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2- patients aged <60 years were 87.2% vs 81.0%, respectively. A beneficial trend in PET2+ patients aged <60 years on A+AVD was also observed, with a 3-year PFS rate of 69.2% vs 54.7% with ABVD. The benefit of A+AVD in the intent-to-treat population appeared independent of disease stage and prognostic risk factors. Upon continued follow-up, 78% of patients with peripheral neuropathy on A+AVD had either complete resolution or improvement compared with 83% on ABVD. These data highlight that A+AVD provides a durable efficacy benefit compared with ABVD for frontline stage III/IV cHL, consistent across key subgroups regardless of patient status at PET2, without need for treatment intensification or bleomycin exposure. This trial was registered at www.clinicaltrials.gov as #NCT01712490 (EudraCT no. 2011-005450-60).",2020,"At a median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2(-) patients aged <60 years were 87.2% versus 81.0%, respectively.","['1334 patients with stage III or IV cHL', 'Stage III/IV classical Hodgkin lymphoma', 'patients with stage III/IV classical Hodgkin lymphoma (cHL) (NCT01712490; 2011-005450-60']","['A+AVD', 'bleomycin', 'ABVD', 'brentuximab vedotin (A) with AVD (A+AVD) exhibited superior modified PFS versus ABVD', 'Brentuximab vedotin with chemotherapy']","['PFS rates', '3-year PFS rate', '3-year PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1334.0,0.136096,"At a median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2(-) patients aged <60 years were 87.2% versus 81.0%, respectively.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Straus', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Długosz-Danecka', 'Affiliation': 'Department of Hematology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Alekseev', 'Affiliation': 'N. N. Petrov Scientific Research Institute of Oncology, St. Petersburg, Russian Federation.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Picardi', 'Affiliation': 'Department of Advanced Biomedical Science, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Lech-Maranda', 'Affiliation': 'Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Smolewski', 'Affiliation': 'Department of Experimental Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Department of Lymphoid Malignancy, The Maria Sklodowska-Curie Memorial Institute and Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': 'Department of Medicine, Graduate School of Medicine, The University of Tennessee, Knoxville, TN.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology Seragnoli, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': 'Department of Hematology, Finsen Centre, National Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': 'Department of Medical Oncology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Munoz', 'Affiliation': 'Department of Lymphoma/Myeloma, Banner MD Anderson Cancer Center, Gilbert, AZ.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine/Oncology, Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited.'}, {'ForeName': 'Keenan', 'Initials': 'K', 'LastName': 'Fenton', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA; and.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA; and.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallamini', 'Affiliation': 'Research and Clinical Innovation, Antoine-Lacassagne Cancer Centre, Nice, France.'}]",Blood,['10.1182/blood.2019003127']
1127,31537812,Ki-67 assessment in early breast cancer: SAKK28/12 validation study on the IBCSG VIII and IBCSG IX cohort.,"The assessment of Ki-67 in early-stage breast cancer has become an important diagnostic tool in planning adjuvant therapy, particularly for the administration of additional chemotherapy to hormone-responsive patients. An accurate determination of the Ki-67 index is of the utmost importance; however, the reproducibility is currently unsatisfactory. In this study, we addressed the predictive/prognostic value of Ki-67 index assessed by using the most reproducible methods, which were identified in the pilot phase. Paraffin blocks obtained from patients with moderately differentiated, estrogen receptor (ER)-positive early-stage breast cancer in Switzerland, who were originally randomized to the treatment arms with and without chemotherapy in the IBCSG VIII-IX trials, were retrieved. Of these 344 randomized patients, we identified 158 patients (82 treated with and 76 treated without chemotherapy) for whom sufficient tumour tissue was available. The presence of Ki-67 was assessed visually by counting 2000 cells at the periphery (A) and estimating the number of positive cells in five different peripheral regions (C), which was determined to be the most reproducible method identified the pilot phase. The prognostic and predictive value was assessed by calculating the breast cancer-free interval (BCFI) and overall survival (OS) rate. Ki-67 was considered a numerical and categorical variable when different cut-off values were used (10%, 14%, 20% and 30%). An mRNA-based subtyping by using the MammaTyper kit with the application of a 20% Ki-67 immunohistochemistry (IHC) cut-off equivalent was also performed. 158 of 344 randomized patients could be included in the Ki-67 analysis. The mean Ki-67 values obtained by using the two methods differed (A: 21.32% and C: 16.07%). Ki-67 assessed by using method A with a cut-off of 10% was a predictive marker for OS, as the hazard ratio (>10% vs. <=10%) in patients with chemotherapy was 0.48 with a 95% confidence interval of [0.19-1.19]. Further, the HR of patients treated without chemotherapy was 3.72 with a 95% confidence interval of [1.16-11.96] (p interaction =0.007). Higher Ki-67 index was not associated with outcome and using the 10% Ki-67 cut-off there was an opposite association for patients with and without chemotherapy. Ki-67 assessments with IHC significantly correlated with MammaTyper results (p=0.002). The exact counting method (A) performed via a light-microscope revealed the predictive value of Ki-67 assessment with a 10% cut-off value. Further analyses employing image analyses and/or mRNA-based-assessments in larger populations are warranted.",2019,"Ki-67 assessed by using method A with a cut-off of 10% was a predictive marker for OS, as the hazard ratio (>10% vs. <=10%) in patients with chemotherapy was 0.48 with a 95% confidence interval of [0.19-1.19].","['patients with moderately differentiated, estrogen receptor (ER)-positive early-stage breast cancer in Switzerland', '158 of 344 randomized patients could be included in the Ki-67 analysis', '344 randomized patients, we identified 158 patients (82 treated with and 76 treated without chemotherapy) for whom sufficient tumour tissue was available', 'early breast cancer']",[],"['mean Ki-67 values', 'breast cancer-free interval (BCFI) and overall survival (OS) rate', 'Higher Ki-67 index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205616', 'cui_str': 'Moderately differentiated (qualifier value)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",344.0,0.0599032,"Ki-67 assessed by using method A with a cut-off of 10% was a predictive marker for OS, as the hazard ratio (>10% vs. <=10%) in patients with chemotherapy was 0.48 with a 95% confidence interval of [0.19-1.19].","[{'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Varga', 'Affiliation': 'Department of Pathology and Molecular Pathology, University Hospital Zurich, Zurich, Switzerland. zsuzsanna.varga@usz.ch.'}, {'ForeName': 'Qiyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Jochum', 'Affiliation': 'Institute of Pathology, Cantonal Hospital, Gt. Gallen, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Perriard', 'Affiliation': 'The Cantonal Institute of Pathology, Locarno, Switzerland.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Rau', 'Affiliation': 'Institute of Pathology, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Christoph', 'Initials': 'JC', 'LastName': 'Tille', 'Affiliation': 'Division of Clinical Pathology, University Hospital Geneva, Geneva, Switzerland.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Hawle', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Klingbiel', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Thuerlimann', 'Affiliation': 'Breast Center, St. Gallen, Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Breast Center, St. Gallen, Cantonal Hospital, St. Gallen, Switzerland.'}]",Scientific reports,['10.1038/s41598-019-49638-4']
1128,31537880,Addition of Epigallocatechin Gallate 400 mg to Sofosbuvir 400 mg + Daclatisvir 60 mg With or Without Ribavirin in Treatment of Patients with Chronic Hepatitis C Improves the Safety Profile: A Pilot Study.,"Emergence of new molecules acting directly on the hepatitic C virus (HCV) has improved treatment outcomes. However, there is a risk of selecting viral escape mutants, so a new combination is needed using different inhibitors that target different steps of the HCV infectious cycle. Novel single tablet formulations were developed: Dactavira, composed of sofosbuvir (SOF) 400 mg/daclatisvir (DCV) 60 mg/epigallocatechin gallate (EGCG) 400 mg without ribavirin (RBV); and Dactavira plus, which includes RBV 800 mg. A randomized, open-label study was carried out on treatment-naïve non-cirrhotic (Group A, n = 50) and treatment-naïve cirrhotic (Group B, n = 22) patients with genotype 4 HCV infection. Group A was randomly assigned to receive a single daily fixed-dose (Dactavira, n = 25) or the standard of care [SOF 400 mg/DCV 60 mg] (n = 25) daily for 12 weeks. Group B was randomly assigned to receive a single daily fixed-dose (Dactavira plus, n = 11) or the standard of care + RBV 800 mg (n = 11) daily for 12 weeks. Patients receiving Dactavira or Dactavira plus had a significantly more rapid rate of viral load decline as compared to patients receiving the standard of care therapy. Sustained virological response for 12 weeks for Dactavira or Dactavira plus showed no statistically significant difference when compared to the standard of care. Also, they did not affect normal hemoglobin levels (p < 0.001) versus the standard of care. The incorporated EGCG interferes with the viral entry mechanisms, as reported by several investigators, and in turn enhances efficacy and prevents relapse as compared to the standard of care. Also, its antihemeolytic and antifibrotic activities may improve the safety and tolerability of the therapy.",2019,Sustained virological response for 12 weeks for Dactavira or Dactavira plus showed no statistically significant difference when compared to the standard of care.,"['Patients with Chronic Hepatitis C', 'treatment-naïve non-cirrhotic (Group A, n\u2009=\u200950) and treatment-naïve cirrhotic (Group B, n\u2009=\u200922) patients with genotype 4 HCV infection']","['single daily fixed-dose (Dactavira, n\u2009=\u200925) or the standard of care [SOF 400\u2009mg/DCV', 'single daily fixed-dose (Dactavira plus, n\u2009=\u200911) or the standard of care\u2009+\u2009RBV 800\u2009mg', 'Dactavira or Dactavira plus', '400\u2009mg without ribavirin (RBV); and Dactavira plus', 'epigallocatechin gallate (EGCG', 'Epigallocatechin Gallate 400\u2009mg to Sofosbuvir 400\u2009mg\u2009+\u2009Daclatisvir 60\u2009mg With or Without Ribavirin']","['Safety Profile', 'normal hemoglobin levels', 'Sustained virological response', 'safety and tolerability', 'rapid rate of viral load decline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C3696663', 'cui_str': 'sofosbuvir 400 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0668209,Sustained virological response for 12 weeks for Dactavira or Dactavira plus showed no statistically significant difference when compared to the standard of care.,"[{'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Shiha', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Reham', 'Initials': 'R', 'LastName': 'Soliman', 'Affiliation': 'Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elbasiony', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Noureldien H E', 'Initials': 'NHE', 'LastName': 'Darwish', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Shaker A', 'Initials': 'SA', 'LastName': 'Mousa', 'Affiliation': 'The Pharmaceutical Research Institute, Albany College of Pharmacy and Health Sciences, Rensselaer, NY, USA. shaker.mousa@acphs.edu.'}]",Scientific reports,['10.1038/s41598-019-49973-6']
1129,31553998,Resistance Training Modulates the Humoral Inflammatory (but Not the DNA Methylation) Profile of Diabetic Older Adults Using Metformin.,"BACKGROUND AND AIM


Inflammatory and methylation imbalances occur in patients with type 2 diabetes mellitus (T2DM). The aim of the present study was to analyze the effect of acute resistance exercise on the inflammatory profile and on DNA methylation of elderly patients with T2DM using metformin.
METHODS


For this purpose, we enrolled 22 male and female older adults (68.2 ± 5.3 years), of whom 13 had controlled T2DM (D) under metformin use and 9 were nondiabetics (ND). All subjects underwent a neuromuscular circuit (8 exercises in 40 min, with each exercise performed in 3 sets of 40 s each and a 20-s interval between repetitions).
RESULTS


The main results indicated a significant difference between groups for baseline interleukin (IL)-10, with a higher concentration in the D group compared to the ND group (p = 0.019). An increase in IL-6 concentration after intervention was observed in group D (p = 0.035). No effect was observed in total DNA methylation within or between groups.
CONCLUSIONS


The resistance training protocol applied in this study modulates the IL-10 and IL-6 concentrations in elderly people with T2DM and under metformin use, possibly as a result of physiological adaptations, with no effect on nondiabetic elderly. No effects on absolute levels of DNA methylation were observed.",2019,"The resistance training protocol applied in this study modulates the IL-10 and IL-6 concentrations in elderly people with T2DM and under metformin use, possibly as a result of physiological adaptations, with no effect on nondiabetic elderly.","['22 male and female older adults (68.2 ± 5.3 years), of whom 13 had controlled T2DM (D) under metformin use and 9 were nondiabetics (ND', 'Diabetic Older Adults', 'elderly people with T2DM and under', 'patients with type 2 diabetes mellitus (T2DM', 'elderly patients with T2DM using metformin']","['Metformin', 'metformin', 'Resistance Training', 'neuromuscular circuit (8 exercises in 40 min, with each exercise', 'acute resistance exercise']","['Humoral Inflammatory', 'baseline interleukin (IL)-10', 'absolute levels of DNA methylation', 'IL-10 and IL-6 concentrations', 'total DNA methylation', 'IL-6 concentration']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",22.0,0.0437132,"The resistance training protocol applied in this study modulates the IL-10 and IL-6 concentrations in elderly people with T2DM and under metformin use, possibly as a result of physiological adaptations, with no effect on nondiabetic elderly.","[{'ForeName': 'Gilberto Santos', 'Initials': 'GS', 'LastName': 'Morais Junior', 'Affiliation': 'Medical Faculty, Universidade de Brasília, Campus Universitário Darcy Ribeiro, Brasília, Brazil.'}, {'ForeName': 'Vinicius Carolino', 'Initials': 'VC', 'LastName': 'Souza', 'Affiliation': 'Medical Faculty, Universidade de Brasília, Campus Universitário Darcy Ribeiro, Brasília, Brazil.'}, {'ForeName': 'Wilcelly', 'Initials': 'W', 'LastName': 'Machado-Silva', 'Affiliation': 'Medical Faculty, Universidade de Brasília, Campus Universitário Darcy Ribeiro, Brasília, Brazil.'}, {'ForeName': 'Adriane Dallanora', 'Initials': 'AD', 'LastName': 'Henriques', 'Affiliation': 'Medical Faculty, Universidade de Brasília, Campus Universitário Darcy Ribeiro, Brasília, Brazil.'}, {'ForeName': 'Gleiciane Gontijo', 'Initials': 'GG', 'LastName': 'Avelar', 'Affiliation': 'Medical Faculty, Universidade de Brasília, Campus Universitário Darcy Ribeiro, Brasília, Brazil.'}, {'ForeName': 'Diego Ignacio Valenzuela', 'Initials': 'DIV', 'LastName': 'Perez', 'Affiliation': 'Kinesiology School and Physical Activity and Sports Science Master Program, Universidad Santo Tomás, Puerto Mont, Chile.'}, {'ForeName': 'Ricardo Moreno', 'Initials': 'RM', 'LastName': 'Lima', 'Affiliation': 'Medical Faculty, Universidade de Brasília, Campus Universitário Darcy Ribeiro, Brasília, Brazil.'}, {'ForeName': 'Roberto Jerônimo Santos', 'Initials': 'RJS', 'LastName': 'Silva', 'Affiliation': 'Physical Education Department, Universidade Federal de Sergipe (UFS), São Cristóvão, Brazil.'}, {'ForeName': 'Ciro José', 'Initials': 'CJ', 'LastName': 'Brito', 'Affiliation': 'Physical Education Department, Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Otávio Toledo', 'Initials': 'OT', 'LastName': 'Nóbrega', 'Affiliation': 'Medical Faculty, Universidade de Brasília, Campus Universitário Darcy Ribeiro, Brasília, Brazil, otavionobrega@unb.br.'}]",Neuroimmunomodulation,['10.1159/000502746']
1130,31527670,Open-label placebos reduce test anxiety and improve self-management skills: A randomized-controlled trial.,"Test anxiety is a condition in which people experience extreme distress and anxiety before and in test situations. It affects up to 40 percent of all students. Conventional treatment includes both medication and psychotherapy, but studies also demonstrated that placebos affect anxiety symptoms. Although in the traditional understanding placebos need to be administered in a concealed way, intriguing new studies report that open-label placebos can be effective. Since prescription of fake pills involves ethical problems, open-label placebos may provide important new treatment possibilities. Here we report results of a pilot study examining whether open-label placebos may reduce test anxiety and improve self-management skills. 58 students participated in a two-group randomized controlled trial. Two weeks before an exam at the university participants received open-label placebos or no pills (control group). Participant - provider relationship and amount of contact time was held similar for all groups. After two weeks we found that test anxiety and self-management abilities (skills and resources) of the open-label placebo group were more improved than in the control group. Thus, our results seems to indicate that open-label placebos may reduce test anxiety and enhance self-management skills in students.",2019,After two weeks we found that test anxiety and self-management abilities (skills and resources) of the open-label placebo group were more improved than in the control group.,"['students', '58 students']","['open-label placebo', 'open-label placebos or no pills (control group', 'open-label placebos', 'Open-label placebos', 'placebos']","['test anxiety and self-management abilities (skills and resources', 'test anxiety and improve self-management skills', 'anxiety symptoms', 'test anxiety and enhance self-management skills']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0496191,After two weeks we found that test anxiety and self-management abilities (skills and resources) of the open-label placebo group were more improved than in the control group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany. michael.schaefer@medicalschool-berlin.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Denke', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Harke', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Olk', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Erkovan', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Enge', 'Affiliation': 'Medical School Berlin, Calandrellistr. 1-9, 12447, Berlin, Germany.'}]",Scientific reports,['10.1038/s41598-019-49466-6']
1131,31527700,Effectiveness of hypnosis for pain management and promotion of health-related quality-of-life among people with haemophilia: a randomised controlled pilot trial.,"Joint deterioration and associated chronic pain are common among people with haemophilia (PWH), having an impact on quality-of-life. Though non-pharmacological strategies are recommended, psychological interventions to promote pain control and quality-of-life have scarcely been tested in haemophilia. This randomised controlled pilot trial aimed to assess feasibility, acceptability and effectiveness of hypnosis for pain management and promotion of health-related quality-of-life (HRQoL) among PWH. Twenty adults were randomised either to four weekly hypnosis sessions plus treatment-as-usual (experimental group; EG) or treatment-as-usual only (control group; CG). Participants completed sociodemographic and clinical assessment, measures of pain, HRQoL and emotional distress before (T1) and after (T2) intervention. Changes were analysed by calculating the differences between T1 and T2, and the groups were compared through independent-sample t tests (or chi-squared). Retention rates (90%) and analysis of patient satisfaction showed good acceptability and feasibility of the intervention. The EG (n = 8) had a higher reduction on pain interference than the CG (n = 10) (d = -0.267). A higher improvement on HRQoL (EQ-5D index: d = 0.334; EQ-5D VAS: d = 1.437) and a tendency towards better haemophilia-related quality-of-life (A36-Hemofilia QoL) were also evident in the EG. This is the first study showing the effectiveness of hypnosis to reduce pain interference and promote HRQoL among PWH.",2019,The EG (n = 8) had a higher reduction on pain interference than the CG (n = 10) (d = -0.267).,"['people with haemophilia', 'people with haemophilia (PWH', 'Twenty adults']","['hypnosis', 'hypnosis sessions plus treatment-as-usual (experimental group; EG) or treatment-as-usual only (control group; CG']","['sociodemographic and clinical assessment, measures of pain, HRQoL and emotional distress', 'pain management and promotion of health-related quality-of-life (HRQoL', 'HRQoL (EQ-5D index', 'Retention rates', 'haemophilia-related quality-of-life (A36-Hemofilia QoL', 'pain interference']","[{'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}]",20.0,0.0895966,The EG (n = 8) had a higher reduction on pain interference than the CG (n = 10) (d = -0.267).,"[{'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Paredes', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.'}, {'ForeName': 'Patrício', 'Initials': 'P', 'LastName': 'Costa', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Fernandes', 'Affiliation': 'Centre of Hemophilia, Department of Transfusion Medicine and Blood Bank, São João University Hospital Centre, Porto, Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Lopes', 'Affiliation': 'Centre of Hemophilia, Department of Transfusion Medicine and Blood Bank, São João University Hospital Centre, Porto, Portugal.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Carvalho', 'Affiliation': 'Centre of Hemophilia, Department of Transfusion Medicine and Blood Bank, São João University Hospital Centre, Porto, Portugal.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Almeida', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.'}, {'ForeName': 'Patrícia Ribeiro', 'Initials': 'PR', 'LastName': 'Pinto', 'Affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal. patipinto@med.uminho.pt.'}]",Scientific reports,['10.1038/s41598-019-49827-1']
1132,32500299,"Changes in spinal bone density, back muscle size, and visceral adipose tissue and their interaction following a multi-component exercise program in older men: secondary analysis of an 18-month randomized controlled trial.","In middle-aged and older men, an 18-month multi-component exercise program improved spinal trabecular BMD, paraspinal, and psoas muscle cross-sectional area (CSA) but not visceral adipose tissue (VAT). However, changes in both muscle and VAT CSA were associated with changes in spinal BMD, independent of the exercise intervention.
INTRODUCTION


In older men, we previously reported that a multi-component exercise program improved lumbar spine (LS) trabecular volumetric BMD (Tb.vBMD) compared with no exercise. This study aimed to investigate the following: (1) the effect of the exercise program on paraspinal and psoas (back) muscle CSA and VAT, and 2) if any exercise-related changes in muscle CSA and/or VAT were associated with changes in spinal BMD.
METHODS


Men (n = 180) aged 50-79 years were randomized to an exercise or no-exercise group. Exercise involved high-intensity progressive resistance training (60-85% max) with weight-bearing impact exercise (3 days/week) for 18 months. Quantitative computed tomography was used to assess L1-L3 Tb.vBMD, paraspinal, and psoas muscle CSA and VAT.
RESULTS


Exercise resulted in a 2.6% ((95% CI, 1.1, 4.1), P < 0.01) net gain in back muscle CSA, but no effect on VAT (-1.6% (95% CI, -7.3, 4.2)) relative to no exercise. Robust regression indicated that percentage changes in Tb.vBMD were positively associated with changes (expressed as z-scores) in back muscle CSA in both the exercise (beta (β)-coefficient = 1.9, 95% CI 0.5, 3.2, P = 0.007) and no-exercise (β = 2.6, 95% CI, 1.1, 4.1, P = 0.001) group, and negatively with the changes in VAT (β = -2.0, 95% CI -3.3, -0.7, P = 0.003) in the exercise only group. There were no group differences in the slopes for the muscle-bone or VAT-bone relationships. Regression analysis (pooled data) revealed that back muscle CSA and VAT were independent predictors of the change in Tb.vBMD, explaining 14% of the variance.
CONCLUSION


A multi-component exercise program in middle-aged and older men improved spinal BMD and back muscle size but not visceral fat. However, changes in back muscle size and VAT were associated with the changes in spinal BMD, independent of exercise.
TRIAL REGISTRATION


ACTRN 12617001224314, 22/08/2017 retrospectively registered.",2020,A multi-component exercise program in middle-aged and older men improved spinal BMD and back muscle size but not visceral fat.,"['Men (n = 180) aged 50-79 years', 'middle-aged and older men', 'older men']","['exercise program', 'Exercise involved high-intensity progressive resistance training (60-85% max) with weight-bearing impact exercise', 'exercise or no-exercise group', 'multi-component exercise program']","['VAT', 'spinal BMD and back muscle size', 'spinal trabecular BMD, paraspinal, and psoas muscle cross-sectional area (CSA', 'lumbar spine (LS) trabecular volumetric BMD (Tb.vBMD', 'Tb.vBMD', 'muscle-bone or VAT-bone relationships', 'spinal bone density, back muscle size, and visceral adipose tissue and their interaction', 'spinal BMD', 'paraspinal and psoas (back) muscle CSA and VAT, and 2', 'net gain in back muscle CSA']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0442145', 'cui_str': 'Paraspinal'}, {'cui': 'C0085221', 'cui_str': 'Structure of psoas muscle'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]",180.0,0.0941906,A multi-component exercise program in middle-aged and older men improved spinal BMD and back muscle size but not visceral fat.,"[{'ForeName': 'A-F', 'Initials': 'AF', 'LastName': 'Turcotte', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Centre, Québec City, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kukuljan', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dalla Via', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gagnon', 'Affiliation': 'Endocrinology and Nephrology Unit, CHU de Québec-Université Laval Research Centre, Québec City, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Abbott', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3128, VIC, Australia. rmdaly@deakin.edu.au.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05484-z']
1133,32229469,Assessing Real-Time Moderation for Developing Adaptive Mobile Health Interventions for Medical Interns: Micro-Randomized Trial.,"BACKGROUND


Individuals in stressful work environments often experience mental health issues, such as depression. Reducing depression rates is difficult because of persistently stressful work environments and inadequate time or resources to access traditional mental health care services. Mobile health (mHealth) interventions provide an opportunity to deliver real-time interventions in the real world. In addition, the delivery times of interventions can be based on real-time data collected with a mobile device. To date, data and analyses informing the timing of delivery of mHealth interventions are generally lacking.
OBJECTIVE


This study aimed to investigate when to provide mHealth interventions to individuals in stressful work environments to improve their behavior and mental health. The mHealth interventions targeted 3 categories of behavior: mood, activity, and sleep. The interventions aimed to improve 3 different outcomes: weekly mood (assessed through a daily survey), weekly step count, and weekly sleep time. We explored when these interventions were most effective, based on previous mood, step, and sleep scores.
METHODS


We conducted a 6-month micro-randomized trial on 1565 medical interns. Medical internship, during the first year of physician residency training, is highly stressful, resulting in depression rates several folds higher than those of the general population. Every week, interns were randomly assigned to receive push notifications related to a particular category (mood, activity, sleep, or no notifications). Every day, we collected interns' daily mood valence, sleep, and step data. We assessed the causal effect moderation by the previous week's mood, steps, and sleep. Specifically, we examined changes in the effect of notifications containing mood, activity, and sleep messages based on the previous week's mood, step, and sleep scores. Moderation was assessed with a weighted and centered least-squares estimator.
RESULTS


We found that the previous week's mood negatively moderated the effect of notifications on the current week's mood with an estimated moderation of -0.052 (P=.001). That is, notifications had a better impact on mood when the studied interns had a low mood in the previous week. Similarly, we found that the previous week's step count negatively moderated the effect of activity notifications on the current week's step count, with an estimated moderation of -0.039 (P=.01) and that the previous week's sleep negatively moderated the effect of sleep notifications on the current week's sleep with an estimated moderation of -0.075 (P<.001). For all three of these moderators, we estimated that the treatment effect was positive (beneficial) when the moderator was low, and negative (harmful) when the moderator was high.
CONCLUSIONS


These findings suggest that an individual's current state meaningfully influences their receptivity to mHealth interventions for mental health. Timing interventions to match an individual's state may be critical to maximizing the efficacy of interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03972293; http://clinicaltrials.gov/ct2/show/NCT03972293.",2020,We found that the previous week's mood negatively moderated the effect of notifications on the current week's mood with an estimated moderation of -0.052 (P=.001).,"['Medical Interns', '1565 medical interns']",['Mobile health (mHealth) interventions'],['activity notifications'],"[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}]",1565.0,0.0508285,We found that the previous week's mood negatively moderated the effect of notifications on the current week's mood with an estimated moderation of -0.052 (P=.001).,"[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'NeCamp', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Molecular and Behavioral Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': 'Molecular and Behavioral Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Addiction Center, Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Ionides', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Molecular and Behavioral Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Tewari', 'Affiliation': 'Department of Statistics, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Zhenke', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, United States.'}]",Journal of medical Internet research,['10.2196/15033']
1134,32054241,Factors Predicting the Need for Early Surgical Intervention for Small Bowel Obstruction.,"PURPOSE


Small bowel obstruction (SBO) is a common disease that requires hospitalization. The most common cause of SBO is postoperative adhesion. Delayed timing of operations in patients who need surgical intervention results in mortality or morbidity. A number of studies on SBO have established criteria for emergency surgery. However, few objective clinical parameters are available for screening patients who need a delayed operation. Therefore, we analyzed factors that affect the clinical course of SBO to select appropriate therapeutic plans for reducing the risk of complications in these patients.
METHODS


We investigated the clinical characteristics of patients admitted to the surgery department of our hospital between January 1, 2015, and December 31, 2016, who were diagnosed with SBO. Patients were divided into an operative treatment group (n = 12) and a conservative treatment group (n = 96). We compared clinical characteristics between the 2 groups.
RESULTS


The operative treatment group underwent more operations before SBO than the conservative treatment group (P = 0.007). Initial leukocyte counts (P = 0.004) and C-reactive protein (CRP) levels (P = 0.028) were elevated in the operative group. Body mass index (BMI) was lower in the operative group (P = 0.013).
CONCLUSION


The number of operations before SBO, leukocyte counts, CRP levels, and BMI were useful parameters for selecting patients who needed an urgent operation for SBO.",2020,The operative treatment group underwent more operations before SBO than the conservative treatment group (p = 0.007).,"['small bowel obstruction', 'patients admitted to the department of surgery of our hospital between January 1, 2015, and December 31, 2016, who were diagnosed as having SBO']",[],"['Body mass index (BMI', 'number of operations before SBO, leukocyte count, CRP level, and BMI', 'initial leukocyte count and C-reactive protein (CRP) level', 'severe mortality and morbidity']","[{'cui': 'C0235329', 'cui_str': 'Small bowel obstruction (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0211731,The operative treatment group underwent more operations before SBO than the conservative treatment group (p = 0.007).,"[{'ForeName': 'Young Jae', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}, {'ForeName': 'In Seok', 'Initials': 'IS', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}, {'ForeName': 'Jungbin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Jin', 'Initials': 'HJ', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}, {'ForeName': 'Geum Hee', 'Initials': 'GH', 'LastName': 'Gwak', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}, {'ForeName': 'Keun Ho', 'Initials': 'KH', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}, {'ForeName': 'Byung Noe', 'Initials': 'BN', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}, {'ForeName': 'Ki Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Inje University Sanggye Paik Hospital, Seoul, Korea.'}]",Annals of coloproctology,['10.3393/ac.2019.09.30']
1135,32494177,"Erratum: Daily Intake of  Kaempferia parviflora  Extract Decreases Abdominal Fat in Overweight and Preobese Subjects: A Randomized, Double-Blind, Placebo-Controlled Clinical Study [Corrigendum].",[This corrects the article DOI: 10.2147/DMSO.S169925.].,2020,[This corrects the article DOI: 10.2147/DMSO.S169925.].,['Overweight and Preobese Subjects'],['Placebo'],['Abdominal Fat'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}]",,0.249468,[This corrects the article DOI: 10.2147/DMSO.S169925.].,[],"Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S260832']
1136,32500154,The poor long-term outcomes of owl's eye pulmonary reconstruction technique after arterial switch operation.,"OBJECTIVES


This study aims to compare the early- and long-term outcomes of patients who undergo owl's eye pulmonary artery (PA) reconstruction to those of patients who undergo conventional PA reconstruction.
METHODS


From January 2016 to January 2017, 64 consecutive patients underwent an arterial switch operation. The patients were divided into 2 groups in terms of neo-PA reconstruction method: 30 patients who underwent neo-PA reconstruction by owl's eye technique were defined as group 1 and 34 patients who underwent neo-PA reconstruction by the conventional approach were defined as group 2. In the final model, after propensity matching, 23 patients from each group with similar propensity scores were included in the study.
RESULTS


There was no significant difference between the groups regarding patient characteristics and operative findings. In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03). In the late period, the rate of severe neo-PS and reintervention was significantly higher in the owl's eye group (P = 0.02 and 0.04). Furthermore, the rates of 3-year freedom from pulmonary reintervention and freedom from moderate-severe neo-PS were significantly lower in group 1 (P = 0.04). In addition, the owl's eye reconstruction was the only factor independently related to moderate-severe neo-PS in the long term (hazard ratios = 11.2, P = 0.02).
CONCLUSIONS


We have abandoned the owl's eye method for neo-PA reconstruction of the neo-PA because of serious complications. According to our series and the literature, reconstruction of the neo-PA with an oversized, pantaloon-shaped fresh autologous pericardial patch is still superior to the other techniques.",2020,"In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03).","['From January 2016 to January 2017, 64 consecutive patients underwent an arterial switch operation', ""patients who undergo owl's eye pulmonary artery (PA) reconstruction to those of patients who undergo conventional PA reconstruction"", '23 patients from each group with similar propensity scores were included in the study']","[""neo-PA reconstruction method: 30 patients who underwent neo-PA reconstruction by owl's eye technique were defined as group 1 and 34 patients who underwent neo-PA reconstruction by the conventional approach"", ""owl's eye pulmonary reconstruction technique after arterial switch operation""]","['duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS', 'rates of 3-year freedom from pulmonary reintervention and freedom from moderate-severe neo-PS', 'rate of severe neo-PS and reintervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0397344', 'cui_str': 'Arterial switch operation'}, {'cui': 'C0326066', 'cui_str': 'Family Strigidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0326066', 'cui_str': 'Family Strigidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0397344', 'cui_str': 'Arterial switch operation'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0034089', 'cui_str': 'Pulmonic valve stenosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",64.0,0.0188175,"In the early period, the duration of intensive care unit and hospital stays and the rate of mild neo-pulmonary stenosis (neo-PS) were significantly higher in the owl's eye group (P = 0.04, 0.04 and 0.03).","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Dedemoğlu', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Mersin City Training and Research Hospital, Mersin, Turkey.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Korun', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gültekin', 'Initials': 'G', 'LastName': 'Coşkun', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Özdemir', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Gazi Yaşargil Education and Research Hospital, Diyarbakır, Turkey.'}, {'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Yurdakök', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Çiçek', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Biçer', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Health Sciences University Erzurum Region Education and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Nurgül', 'Initials': 'N', 'LastName': 'Yurtseven', 'Affiliation': 'Department of Anesthesia and Reanimation, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Şaşmazel', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Numan Ali', 'Initials': 'NA', 'LastName': 'Aydemir', 'Affiliation': 'Department of Pediatric Cardiovascular Surgery, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa067']
1137,32200284,"Corrigendum to ""The efficacy of labetalol versus nitroglycerin for induction of controlled hypotension during sinus endoscopic surgery. A prospective, double-blind and randomized study"" [J. Clin. Anesth. 39 (2017) 154-158].",,2020,,"['39', 'controlled hypotension during sinus endoscopic surgery']",['labetalol versus nitroglycerin'],[],"[{'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]",[],,0.177486,,"[{'ForeName': 'Nagat S', 'Initials': 'NS', 'LastName': 'Elshmaa', 'Affiliation': 'Department of Anesthesia & Surgical ICU, Faculty of Medicine, Tanta University, Egypt. Electronic address: nagat.elshamaa@med.tanta.edu.eg.'}, {'ForeName': 'Hoda Alsaid Ahmed', 'Initials': 'HAA', 'LastName': 'Ezz', 'Affiliation': 'Department of Anesthesia & Surgical ICU, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Department of ENT, Faculty of Medicine, Tanta University, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109788']
1138,32268000,A Single and Multiple Ascending Dose Study of Toll-Like Receptor 7 Agonist (RO7020531) in Chinese Healthy Volunteers.,"Toll-like receptor 7 (TLR7) agonists modulate broad spectrum immune activity and are evaluated in the treatment of human diseases, including cancer and chronic viral infection. RO7020531, an oral prodrug of a TLR7 agonist, is in clinical development as part of a curative regimen against chronic hepatitis B. We report the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of RO7020531 in healthy Chinese volunteers following single and multiple ascending doses (SAD and MAD). PK and PD samples were evaluated from four SAD cohorts and 3 MAD cohorts with 10 subjects each (8 active and 2 placebo). Safety and tolerability were monitored throughout the study. A total of 155 adverse events (AEs) were reported in 49 subjects. Fifty-one AEs in 18 subjects were assessed as treatment-related. Most of the AEs were mild; nine subjects experienced moderate AEs; there were no severe AEs. In two 150 mg MAD cohorts given every other day (q.o.d.), 7 of 20 subjects experienced pyrexia and were discontinued due to transient asymptomatic lymphopenia, which resolved 24-48 hours postdose. The PK of the active metabolite, RO7011785, increased linearly with dose from 40 mg to 170 mg. There was no PK accumulation following q.o.d. dosing. The PK profile is consistent with observations in white subjects in the global first-in-human study. SADs and MADs of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100 mg or above. Flu-like symptoms were associated with higher interferon-α levels. RO7020531 was safe and acceptably tolerated in healthy Chinese volunteers with a multiple 150 mg q.o.d. dose regimen.",2020,Single and multiple doses of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100mg or above.,"['Chinese healthy volunteers', 'Chinese healthy volunteers following single and multiple ascending doses (SAD & MAD', 'Chinese Healthy Volunteers']","['Toll', 'Like Receptor 7 (TLR 7) Agonist (RO7020531', 'RO7020531', 'TLR7 agonist', 'TLR7']","['TLR7 response markers', 'Safety and tolerability', 'safe and acceptably tolerated', 'PK accumulation', 'safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}]","[{'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",18.0,0.0606734,Single and multiple doses of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100mg or above.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Luk', 'Affiliation': 'Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Qiudi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Glavini', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Triyatni', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Roche Pharma Development Shanghai, Shanghai, China.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Racek', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Grippo', 'Affiliation': 'Roche Innovation Center New York, New York, New York, USA.'}]",Clinical and translational science,['10.1111/cts.12791']
1139,26654223,"""It's not just about walking.....it's the practice nurse that makes it work"": a qualitative exploration of the views of practice nurses delivering complex physical activity interventions in primary care.","BACKGROUND


Physical activity (PA) is important for physical and mental health in adults and older adults. Interventions incorporating theory-based behaviour change techniques (BCTs) can be useful in helping people to increase their PA levels and can be delivered by practice nurses in primary care. We undertook two primary care based complex walking interventions among adults and older adults. Both interventions were underpinned by BCTs and delivered by practice nurses and we sought their views and experiences of delivering over 1400 complex PA consultations.
METHODS


Semi structured interviews with two practice nurse groups (n = 4 and n = 5) and two individual interviews (total n = 11) were conducted by independent facilitators; audio-recorded, transcribed verbatim and analysed using thematic analysis.
RESULTS


Five key themes emerged as enablers and/or barriers to delivering the intervention: preparation and training; initial and ongoing support; adherence to the protocol; the use of materials and equipment; and engagement of participants. The themes were organised into a framework of 'pre-trial' and 'delivery of the intervention'. Two additional 'post-trial' themes were identified; changed practice and the future feasibility of the intervention. Nurses believed that taking part in the trial, especially the BCT training, enhanced the quality and delivery of advice and support they provided within routine consultations, although the lack of time available routinely makes this challenging.
CONCLUSION


Delivering an effective behaviour change intervention in primary care requires adequate training and support for practice nurses both initially and throughout the trial as well as adequate consultation time. Enhanced skills from participating in such trials can lead to long-term changes, including more patient-centred consulting.
TRIAL REGISTRATION


PACE-Lift ISRCTN 42122561 , PACE-UP ISRCTN 98538934 .",2015,Delivering an effective behaviour change intervention in primary care requires adequate training and support for practice nurses both initially and throughout the trial as well as adequate consultation time.,"['Semi structured interviews with two practice nurse groups (n\u2009=\u20094 and n\u2009=\u20095) and two individual interviews (total n\u2009=\u200911', 'adults and older adults']","['Physical activity (PA', 'primary care based complex walking interventions', 'Interventions incorporating theory-based behaviour change techniques (BCTs']",[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",[],,0.0239894,Delivering an effective behaviour change intervention in primary care requires adequate training and support for practice nurses both initially and throughout the trial as well as adequate consultation time.,"[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Beighton', 'Affiliation': ""Faculty of Health, Social Care & Education, Kingston & St George's University of London, London, SW17 ORE, UK. c.beighton@sgul.kingston.ac.uk.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Victor', 'Affiliation': 'College of Health and Life Sciences, Brunel University London, Middlesex, UB8 3PH, UK. christina.victor@brunel.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Normansell', 'Affiliation': 'Population Health Research Institute, St Georges University of London, London, SW17 ORE, UK. rnormans@sgul.ac.uk.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': 'Population Health Research Institute, St Georges University of London, London, SW17 ORE, UK. sgjd250@sgul.ac.uk.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kerry', 'Affiliation': ""Pragmatic Clinical Trials Unit, Queen Mary's University of London, London, E1 2AT, UK. s.m.kerry@qmul.ac.uk.""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Iliffe', 'Affiliation': 'Research Department of Primary Care & Population Health, University College, London, NW3 2PF, UK. s.iliffe@ucl.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': 'Population Health Research Institute, St Georges University of London, London, SW17 ORE, UK. mussher@sgul.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whincup', 'Affiliation': 'Population Health Research Institute, St Georges University of London, London, SW17 ORE, UK. pwhincup@sgul.ac.uk.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fox-Rushby', 'Affiliation': 'Health Economics Research Group, Brunel University, Uxbridge, UB8 3PH, UK. Julia.fox-Rushby@brunel.ac.uk.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Woodcock', 'Affiliation': 'Independent Psychology Research Consultant, Southampton, UK. alison.woodcock@chalto.co.uk.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Population Health Research Institute, St Georges University of London, London, SW17 ORE, UK. tharris@sgul.ac.uk.'}]",BMC public health,['10.1186/s12889-015-2568-6']
1140,32508602,"Corrigendum: The Immediate Effect of Therapeutic Touch and Deep Touch Pressure on Range of Motion, Interoceptive Accuracy and Heart Rate Variability: A Randomized Controlled Trial With Moderation Analysis.",[This corrects the article DOI: 10.3389/fnint.2018.00041.].,2020,[This corrects the article DOI: 10.3389/fnint.2018.00041.].,[],['Therapeutic Touch and Deep Touch Pressure'],"['Range of Motion, Interoceptive Accuracy and Heart Rate Variability']",[],"[{'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0665528,[This corrects the article DOI: 10.3389/fnint.2018.00041.].,"[{'ForeName': 'Darren J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Curtis', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Johnston', 'Affiliation': 'Department of Interprofessional Health Studies, Swansea University, Swansea, United Kingdom.'}]",Frontiers in integrative neuroscience,['10.3389/fnint.2020.00028']
1141,32241575,"Letter to the Editor re 'Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial'.",,2020,,[],['cryotherapy'],[],[],"[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",[],,0.0267955,,"[{'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Kwiecien', 'Affiliation': 'Nicholas Institute of Sports Medicine and Athletic Trauma, Lenox Hill Hospital, New York, NY, USA; Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK. Electronic address: susan@nismat.org.'}]",Physiotherapy,['10.1016/j.physio.2020.02.007']
1142,31126208,Temperature-sensitive anti-adhesive poloxamer hydrogel decreases fascial adhesion in total knee arthroplasty: A prospective randomized controlled study.,,2019,"There were no significant differences in postoperative fascial thickness, pain visual analogue scale, analgesics consumption, clinical scores, or degree of satisfaction.","['Sixty patients who underwent unilateral primary total knee arthroplasty for knee osteoarthritis', 'after total knee arthroplasty', 'total knee arthroplasty']","['TAP hydrogel', 'Temperature-sensitive anti-adhesive poloxamer hydrogel', 'TAP group or control group', 'TAP hydrogel group, while normal saline']","['fascial adhesion and clinical outcomes including range of motion, pain, and patient satisfaction', 'surgical site complication', 'degree of skin fold, fascial thickness measured with ultra-sonography, postoperative pain visual analogue scale, total cumulative analgesics consumption, clinical scores, and degree of satisfaction', 'degree of suprapatellar skin folding', 'efficacy and safety', 'postoperative fascial adhesion', 'range of motion', 'postoperative fascial thickness, pain visual analogue scale, analgesics consumption, clinical scores, or degree of satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0086827', 'cui_str': 'Poloxamers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",60.0,0.0178106,"There were no significant differences in postoperative fascial thickness, pain visual analogue scale, analgesics consumption, clinical scores, or degree of satisfaction.","[{'ForeName': 'Jong-Keun', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': '1 Hanil General Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Do Weon', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Du Hyun', 'Initials': 'DH', 'LastName': 'Ro', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Chul', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': '2 Seoul National University Hospital, Seoul, Republic of Korea.'}]",Journal of biomaterials applications,['10.1177/0885328219852890']
1143,32501212,The effects of mandibular advancement appliance therapy on jaw-closing muscle activity during sleep in patients with obstructive sleep apnea: a 3-6 months follow-up.,"STUDY OBJECTIVES


The main aim of this study was to investigate the effects of mandibular advancement appliance (MAA) therapy on jaw-closing muscle activity (JCMA) time-related to respiratory arousals, and on JCMA time-related to nonrespiratory arousals in patients with obstructive sleep apnea.
METHODS


Eighteen patients with OSA (mean ± standard deviation = 49.4 ± 9.8 years) with a mean ± standard deviation apnea-hypopnea index of 22.0 ± 16.0 events/h of sleep participated in a randomized controlled crossover trial in which two ambulatory polysomnographic recordings, 1 with an MAA in situ and another without the MAA in situ, were performed. JCMA was quantified as the sum of rhythmic masticatory muscle activities and other orofacial activities.
RESULTS


Significant reductions in the apnea-hypopnea index (Z = -2.984; P = .003), in the respiratory arousal index (Z = -2.896; P = .004), and in the JCMA time-related to respiratory arousal index (Z = -3.434; P = .001) were found with MAA in situ. On the nonrespiratory arousal index, and on the JCMA time-related to nonrespiratory arousal index, MAA had no significant effect (T = 2.23; P = .82; and Z = -0.66; P = .51, respectively).
CONCLUSIONS


This study shows that effective mandibular advancement appliance therapy significantly reduces jaw-closing muscle activities time-related to respiratory arousals in OSA patients. Future studies are needed to confirm these findings in obstructive sleep apnea patients with comorbid sleep bruxism.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: The Effects of Oral Appliance Therapy on Masseter Muscle Activity in Obstructive Sleep Apnea; Identifier: NCT02011425.",2020,"RESULTS


Significant reductions in the AHI (Z = -2.984; P = 0.003), in the respiratory arousal index (Z = - 2.896; P = 0.004), and in the JCMA time-related to respiratory arousal index (Z = -3.434; P = 0.001) were found with MAA in situ.","['patients with obstructive sleep apnea', 'OSA patients with comorbid sleep bruxism', 'OSA patients', 'patients with obstructive sleep apnea (OSA', 'Eighteen patients with OSA (mean ± SD = 49.4 ± 9.8 years) with a mean ± SD apnea-hypopnea index (AHI) of 22.0 ± 16.0 events/hour of sleep participated']","['mandibular advancement appliance therapy', 'JCMA', 'mandibular advancement appliance (MAA) therapy', 'ambulatory polysomnographic recordings, one with an MAA in situ and another without the MAA']","['jaw-closing muscle activities time-related to respiratory arousals', 'jaw-closing muscle activity (JCMA) time-related to respiratory arousals, and on JCMA time-related to non-respiratory arousals', 'respiratory arousal index', 'JCMA time-related to respiratory arousal index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444498', 'cui_str': 'In situ'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",18.0,0.0219551,"RESULTS


Significant reductions in the AHI (Z = -2.984; P = 0.003), in the respiratory arousal index (Z = - 2.896; P = 0.004), and in the JCMA time-related to respiratory arousal index (Z = -3.434; P = 0.001) were found with MAA in situ.","[{'ForeName': 'Ghizlane', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Arcache', 'Affiliation': 'Faculté de Médecine Dentaire, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Gilles J', 'Initials': 'GJ', 'LastName': 'Lavigne', 'Affiliation': 'Faculté de Médecine Dentaire, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Huynh', 'Affiliation': 'Faculté de Médecine Dentaire, Université de Montréal, Montréal, Canada.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8612']
1144,32501814,Ethanol-Based Disinfectants Containing Urea May Reduce Soap Sensitivity.,"BACKGROUND


The use of disinfectants is crucial to preventing the spread of nosocomial infections in health care workers. As many as 25 applications of hand disinfectants is a realistic default value during a working day. However, alcohol-based hand disinfectants may weaken skin barrier function and induce dryness and eczema, which decrease their acceptance.
OBJECTIVE


To evaluate the effect of ethanol-containing disinfectants with 5% urea on skin barrier function and on sensitivity to an irritant soap (sodium lauryl sulfate [SLS]).
METHODS


Twenty healthy volunteers treated one of their forearms twice daily for 17 days with an ethanol-containing gel with 5% urea. Two types of gels with urea were tested. Treatment was randomized to left or right forearm, and the contralateral forearm served as untreated control. Transepidermal water loss, skin capacitance (dryness), and sensitivity to SLS were evaluated.
RESULTS


Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
CONCLUSIONS


Improved barrier function using this ethanol gel with urea may have relevance in daily disinfectant procedures.",2020,"RESULTS


Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
","['Twenty healthy volunteers treated one of their forearms twice daily for 17 days with an', 'health care workers']","['Ethanol-Based Disinfectants Containing Urea', 'ethanol-containing disinfectants', 'contralateral forearm served as untreated control', 'irritant soap (sodium lauryl sulfate [SLS', 'ethanol-containing gel with 5% urea']","['skin barrier function and induce dryness and eczema', 'Transepidermal water loss, skin capacitance (dryness), and sensitivity to SLS', 'skin barrier function', 'Soap Sensitivity', 'transepidermal water loss, prevented dryness, and reduced sensitivity to SLS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",20.0,0.0301597,"RESULTS


Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lodén', 'Affiliation': 'From the Eviderm Institute AB, Solna, Sweden.'}]","Dermatitis : contact, atopic, occupational, drug",['10.1097/DER.0000000000000612']
1145,32501815,Who is Reached by HIV Self-Testing? Individual Factors Associated With Self-Testing Within a Community-Based Program in Rural Malawi.,"INTRODUCTION


HIV self-testing (HIVST) is an alternative strategy for reaching population subgroups underserved by available HIV testing services. We assessed individual factors associated with ever HIVST within a community-based program.
SETTING


Malawi.
METHODS


We conducted secondary analysis of an end line survey administered under a cluster-randomized trial of community-based distribution of HIVST kits. We estimated prevalence differences and prevalence ratios (PRs) stratified by sex for the outcome: self-reported ever HIVST.
RESULTS


Prevalence of ever HIVST was 45.0% (475/1055) among men and 40.1% (584/1456) among women. Age was associated with ever HIVST in both men and women, with evidence of a strong declining trend across categories of age. Compared with adults aged 25-39 years, HIVST was lowest among adults aged 40 years and older for both men [34.4%, 121/352; PR 0.74, 95% confidence interval (CI): 0.62 to 0.88] and women (30.0%, 136/454; PR 0.71, 95% CI: 0.6 to 0.84). Women who were married, had children, had higher levels of education, or were wealthier were more likely to self-test. Men who had condomless sex in the past 3 months (47.9%, 279/582) reported a higher HIVST prevalence compared with men who did not have recent condomless sex (43.1%, 94/218; adjusted PR 1.37, 95% CI: 1.06 to 1.76). Among men and women, the level of previous exposure to HIV testing and household HIVST uptake was associated with HIVST.
CONCLUSIONS


Community-based HIVST reached men, younger age groups, and some at-risk individuals. HIVST was lowest among older adults and individuals with less previous exposure to HIV testing, suggesting the presence of ongoing barriers to HIV testing.",2020,"Compared with adults aged 25-39 years, HIVST was lowest among adults aged 40 years and older for both men (34.4%, 121/352; PR 0.74, 95% CI 0.62-0.88) and women (30.0%, 136/454; PR 0.71, 95% CI 0.6-0.84).","['Women who were married, had children']","['HIV self-testing (HIVST', 'HIVST kits', 'HIVST']","['HIVST prevalence', 'Prevalence of ever HIVST', 'level of previous exposure to HIV testing and household HIVST uptake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0020052', 'cui_str': 'Households'}]",,0.111305,"Compared with adults aged 25-39 years, HIVST was lowest among adults aged 40 years and older for both men (34.4%, 121/352; PR 0.74, 95% CI 0.62-0.88) and women (30.0%, 136/454; PR 0.71, 95% CI 0.6-0.84).","[{'ForeName': 'Pitchaya P', 'Initials': 'PP', 'LastName': 'Indravudh', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Nzawa', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chilongosi', 'Affiliation': 'Population Services International, Lilongwe, Malawi.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Nyirenda', 'Affiliation': 'Department of HIV and AIDS, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Cheryl C', 'Initials': 'CC', 'LastName': 'Johnson', 'Affiliation': 'Global HIV, hepatitis and sexually transmitted infections programs, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hatzold', 'Affiliation': 'Population Services International, Washington D.C.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'Department of Infectious Disease Epidemiology and MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Neuman', 'Affiliation': 'Department of Infectious Disease Epidemiology and MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002412']
1146,32506100,"Home Based Pulmonary Rehabilitation on Oxygenation Status, Dyspnea and Fatigue in Stable Patients with COPD.","Pulmonary rehabilitation (PR) program of a sufficient duration has impact on consequence of COPD. To evaluate the effects of combination of pursed lip breathing (PLB), diaphragmatic breathing (DB) and lower extremity endurance training (LEET) as part of PR program in stable patients with COPD on oxygenation status, dyspnea and fatigue. This prospective interventional study was performed in the Department of Physiology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from July 2010 to June 2011 and was performed on 116 male stable moderate COPD patients aged 50 to 65 years. Among them, 56 patients were without PR (control group) and 60 patients were intervened with PR (experimental group). The experimental patients were advised to perform the home based PR program (PLB, DB and LEET) for 30 minutes duration per session at home twice per day, along with standard drug treatment of COPD for uninterrupted 60 days. The control patients continued their treatment of COPD with standard drug for successive 60 days were advised. To evaluate the effects of PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale from baseline to end of six minute walk test (6MWT) of all subjects were recorded on day 0 and day 60 for both the groups. Independent sample 't' test and paired Student's 't' test were done with SPSS software. In the interpretation of results, p value of <0.05 was considered as statistically significant. In the present study, we found less decrement of SpO₂ and less increment of level of dyspnea as well as level of fatigue after 6MWT in the COPD patients with PR on 60th day of follow up. The study reveals that oxygenation status, dyspnea and fatigue improve after execution of regular home based PR program in patients with moderate stable COPD.",2020,"To evaluate the effects of PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale from baseline to end of six minute walk test (6MWT) of all subjects were recorded on day 0 and day 60 for both the groups.","['patients with moderate stable COPD', '56 patients were without PR (control group) and 60 patients were intervened with PR (experimental group', 'stable patients with COPD on oxygenation status, dyspnea and fatigue', 'Stable Patients with COPD', 'Department of Physiology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from July 2010 to June 2011 and was performed on 116 male stable moderate COPD patients aged 50 to 65 years']","['pursed lip breathing (PLB), diaphragmatic breathing (DB) and lower extremity endurance training (LEET', 'Pulmonary rehabilitation (PR) program', 'Home Based Pulmonary Rehabilitation', 'home based PR program (PLB, DB and LEET']","['Oxygenation Status, Dyspnea and Fatigue', 'PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale', 'oxygenation status, dyspnea and fatigue', 'level of dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}]",116.0,0.015404,"To evaluate the effects of PR, Peripheral capillary oxygen saturation (SpO₂, by pulse Oximeter), level of dyspnea and level of fatigue by Modified Borg Scale from baseline to end of six minute walk test (6MWT) of all subjects were recorded on day 0 and day 60 for both the groups.","[{'ForeName': 'N U', 'Initials': 'NU', 'LastName': 'Ahmed', 'Affiliation': 'Major (Dr) Mohammad Nesar Uddin Ahmed, Medical Officer, 21 Field Ambulance, Bogura Cantonment, Bogura, Bangladesh. E-mail ID: nesarj9@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Begum', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ali', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Suhana', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1147,32506135,Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study.,"CONTEXT


Although dietary potassium and sodium intake may influence calcium-phosphate metabolism and bone health, the effects on bone mineral parameters, including fibroblast growth factor 23 (FGF23), are unclear.
OBJECTIVE


Here, we investigated the effects of potassium or sodium supplementation on bone mineral parameters.
DESIGN, SETTING, PARTICIPANTS


We performed a post hoc analysis of a dietary controlled randomized, blinded, placebo-controlled crossover trial. Prehypertensive individuals not using antihypertensive medication (n = 36) received capsules containing potassium chloride (3 g/d), sodium chloride (3 g/d), or placebo. Linear mixed-effect models were used to estimate treatment effects.
RESULTS


Potassium supplementation increased plasma phosphate (from 1.10 ± 0.19 to 1.15 ± 0.19 mmol/L, P = 0.004), in line with an increase in tubular maximum of phosphate reabsorption (from 0.93 ± 0.21 to 1.01 ± 0.20 mmol/L, P < 0.001). FGF23 decreased (114.3 [96.8-135.0] to 108.5 [93.5-125.9] RU/mL, P = 0.01), without change in parathyroid hormone and 25-hydroxy vitamin D3. Fractional calcium excretion decreased (from 1.25 ± 0.50 to 1.11 ± 0.46 %, P = 0.03) without change in plasma calcium. Sodium supplementation decreased both plasma phosphate (from 1.10 ± 0.19 to 1.06 ± 0.21 mmol/L, P = 0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P = 0.02). Urinary and fractional calcium excretion increased (from 4.28 ± 1.91 to 5.45 ± 2.51 mmol/24 hours, P < 0.001, and from 1.25 ± 0.50 to 1.44 ± 0.54 %, P = 0.004, respectively).
CONCLUSIONS


Potassium supplementation led to a decrease in FGF23, which was accompanied by increase in plasma phosphate and decreased calcium excretion. Sodium supplementation reduced FGF23, but this was accompanied by decrease in phosphate and increase in fractional calcium excretion. Our results indicate distinct effects of potassium and sodium intake on bone mineral parameters, including FGF23.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01575041.",2020,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).",['hypertensive individuals not using antihypertensive medication (n=36) received'],"['Potassium or Sodium Supplementation', 'sodium chloride', 'capsules containing potassium chloride', 'Potassium supplementation', 'dietary potassium and sodium intake', 'potassium and sodium intake', 'potassium or sodium supplementation', 'Sodium supplementation', 'placebo']","['parathyroid hormone and 25(OH)-vitamin D3', 'Fractional calcium excretion', 'bone mineral parameters, including FGF23', 'Mineral Homeostasis', 'Urinary and fractional calcium excretion', 'plasma calcium', 'bone mineral parameters', 'plasma phosphate', 'FGF23', 'plasma phosphate and decreased calcium excretion', 'tubular maximum of phosphate reabsorption', 'fractional calcium excretion']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}, {'cui': 'C0162800', 'cui_str': 'Dietary Potassium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1272114', 'cui_str': 'Plasma calcium level'}, {'cui': 'C0858147', 'cui_str': 'Plasma phosphate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}]",,0.11207,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).","[{'ForeName': 'Jelmer K', 'Initials': 'JK', 'LastName': 'Humalda', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Stanley M H', 'Initials': 'SMH', 'LastName': 'Yeung', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Geleijnse', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, HB Wageningen, the Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Gijsbers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, HB Wageningen, the Netherlands.'}, {'ForeName': 'Ineke J', 'Initials': 'IJ', 'LastName': 'Riphagen', 'Affiliation': 'Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, CA Rotterdam, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, RC Leiden, the Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, DD Amsterdam Zuidoost, the Netherlands.'}, {'ForeName': 'Gerjan', 'Initials': 'G', 'LastName': 'Navis', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa359']
1148,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1149,32513836,"Multicenter Phase I Trial of a DNA Vaccine Encoding the Androgen Receptor Ligand-binding Domain (pTVG-AR, MVI-118) in Patients with Metastatic Prostate Cancer.","PURPOSE


Preclinical studies demonstrated that a DNA vaccine (pTVG-AR, MVI-118) encoding the androgen receptor ligand-binding domain (AR LBD) augmented antigen-specific CD8 +  T cells, delayed prostate cancer progression and emergence of castration-resistant disease, and prolonged survival of tumor-bearing mice. This vaccine was evaluated in a multicenter phase I trial.
PATIENTS AND METHODS


Patients with metastatic castration-sensitive prostate cancer (mCSPC) who had recently begun androgen deprivation therapy were randomly assigned to receive pTVG-AR on one of two treatment schedules over one year, and with or without GM-CSF as a vaccine adjuvant. Patients were followed for 18 months. Primary objectives were safety and immune response. Secondary objectives included median time to PSA progression, and 18-month PSA-PFS (PPFS).
RESULTS


Forty patients were enrolled at three centers. Twenty-seven patients completed treatment and 18 months of follow-up. Eleven patients (28%) had a PSA progression event before the 18-month time point. No grade 3 or 4 adverse events were observed. Of 30 patients with samples available for immune analysis, 14 (47%) developed Th1-type immunity to the AR LBD, as determined by IFNγ and/or granzyme B ELISPOT. Persistent IFNγ immune responses were observed irrespective of GM-CSF adjuvant. Patients who developed T-cell immunity had a significantly prolonged PPFS compared with patients without immunity (HR = 0.01; 95% CI, 0.0-0.21;  P  = 0.003).
CONCLUSIONS


pTVG-AR was safe and immunologically active in patients with mCSPC. Association between immunity and PPFS suggests that treatment may delay the time to castration resistance, consistent with preclinical findings, and will be prospectively evaluated in future trials. See related commentary by Shenderov and Antonarakis, p. 5056 .",2020,"Patients who developed T-cell immunity had a significantly prolonged PPFS compared to patients without immunity (HR=0.01, 95% CI: 0.0-0.21, p=0.003).
","['Patients with Metastatic Prostate Cancer', 'Patients with metastatic castration sensitive prostate cancer (mCSPC) who had recently begun androgen deprivation therapy', 'Forty patients were enrolled at three centers', 'patients with mCSPC']","['pTVG-AR', 'DNA', 'Vaccine Encoding the Androgen Receptor Ligand Binding Domain (pTVG-AR, MVI-118', 'DNA vaccine (pTVG-AR, MVI-118']","['safety and immune response', 'grade 3 or 4 adverse events', 'PSA progression event', 'median time to PSA progression, and 18-month PSA-progression-free survival (PPFS', 'PPFS', 'Persistent IFNγ immune responses', 'Th1-type immunity to the AR LBD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",40.0,0.0764183,"Patients who developed T-cell immunity had a significantly prolonged PPFS compared to patients without immunity (HR=0.01, 95% CI: 0.0-0.21, p=0.003).
","[{'ForeName': 'Christos E', 'Initials': 'CE', 'LastName': 'Kyriakopoulos', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Eickhoff', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferrari', 'Affiliation': 'Department of Oncology, Albert Einstein College of Medicine, Montefiore Medical Center for Cancer Care, New York, New York.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Schweizer', 'Affiliation': 'University of Washington/Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wargowski', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Olson', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Douglas G', 'Initials': 'DG', 'LastName': 'McNeel', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin. dm3@medicine.wisc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0945']
1150,32520346,Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study.,"BACKGROUND


Dietary Guidelines for Americans recommend the consumption of 3 servings/d of low-fat/nonfat dairy. The effects of higher dairy consumption and its fat content are unknown in patients with type 2 diabetes.
OBJECTIVE


Evaluate the impact of higher consumption of high- compared with low-fat dairy on glycated hemoglobin (HbA1c), body weight, and cardiovascular disease risk factors in patients with type 2 diabetes.
METHODS


We enrolled 111 subjects with type 2 diabetes (aged 58.5 ± 8.9 y, 47% females, diabetes duration 13.2 ± 8.3 y, HbA1c 8.09 ± 0.96%) who consumed <3 servings of dairy/d. We randomly assigned them into 3 groups: control group maintained baseline dairy intake, low-fat (LF) group incorporated ≥3 servings/d of LF dairy, and the high-fat (HF) group incorporated ≥3 servings/d of HF dairy. We evaluated HbA1c, body weight, BMI, body composition parameters, blood pressure (BP), lipid parameters, homeostatic model assessment of insulin resistance (HOMA-IR), and total energy and macronutrient intake at baseline, and after 12 and 24 wk.
RESULTS


At 24 wk, percent energy from saturated fat increased from baseline in the HF group by 3.6%, (95% CI: 2.2, 5.1) and decreased in the LF group by -1.9% (95% CI: -3.3, -0.4). The LF group increased their percent energy from protein by 4.5% (95% CI: 2.6, 6.4), whereas the HF group decreased their percent energy from carbohydrates by -3.4% (95% CI: -0.2, -6.7). There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk.
CONCLUSION


In patients with type 2 diabetes, increased dairy consumption to ≥3 servings/d compared with <3 servings/d, irrespective of its fat content, while maintaining energy intake has no effect on HbA1c, body weight, body composition, lipid profile, or BP. This trial was registered at clinicaltrials.gov as NCT02895867.",2020,"There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk.
CONCLUSION


","['111 subjects with type 2 diabetes (aged 58.5\xa0±\xa08.9 y, 47% females, diabetes duration 13.2\xa0±\xa08.3 y, HbA1c 8.09\xa0±\xa00.96%) who consumed\xa0<3 servings of dairy/d', 'patients with type 2 diabetes']","['dairy consumption and its fat content', 'control group maintained baseline dairy intake, low-fat (LF) group incorporated\xa0≥3 servings/d of LF dairy, and the high-fat (HF) group incorporated\xa0≥3 servings/d of HF dairy', 'high- compared with low-fat dairy']","['glycated hemoglobin (HbA1c), body weight, and cardiovascular disease risk factors', 'HbA1c, body weight, body composition, lipid profile, or BP', 'glycemic control and cardiovascular disease risk factors', 'percent energy from protein', 'mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP', 'dairy consumption', 'percent energy from saturated fat', 'HbA1c, body weight, BMI, body composition parameters, blood pressure (BP), lipid parameters, homeostatic model assessment of insulin resistance (HOMA-IR), and total energy and macronutrient intake']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",111.0,0.0619029,"There were no differences in the mean changes in HbA1c, body weight, BMI, body composition or lipid parameters, or BP between the 3 groups at 24 wk.
CONCLUSION


","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitri', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Tomah', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Adham', 'Initials': 'A', 'LastName': 'Mottalib', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Salsberg', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Ashrafzadeh', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pober', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Eldib', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Mhd Wael', 'Initials': 'MW', 'LastName': 'Tasabehji', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hamdy', 'Affiliation': 'Research Division, Joslin Diabetes Center, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa138']
1151,32520354,Autologous bone marrow cell transplantation in the treatment of HIV patients with compensated cirrhosis.,"Liver stem cell therapy is a promising tool to improve decompensated liver cirrhosis (DLC). Especially in patients infected with human immunodeficiency virus (HIV), the condition of the liver may be aggravated by antiretroviral therapy. A total of 21 patients diagnosed with DLC and HIV infection were divided into two groups as follows: those who received (combination therapy group, 14 patients) and those who did not receive (routine therapy group, 7 patients) bone marrow cell transplantation through the portal vein. Two patients died of surgery-related complications in the combination therapy group. The results showed that the survival rate was 85.7% in the combination therapy group after 2 years of follow-up, which was significantly higher than the 14.3% in the conventional therapy group (P<0.01). After treatment, the liver function score decreased significantly in the combination therapy group at 1 (t = 4.276, P = 0.000), 3 (t = 9.153, P = 0.000), and 12 (t = 13.536, P = 0.000) months, the levels of albumin were significantly increased, and the total bilirubin level and prothrombin time were significantly reduced or shortened as compared with the routine therapy group (P<0.05 or <0.01). The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared with the routine therapy group (P<0.05 or <0.01). In summary, the combination therapy is effective in HIV-infected patients with DLC and useful for the recovery of liver function and cellular immune function but may increase the risk of severe complications after surgery.",2020,"The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared to the routine therapy group (P<0.05 or <0.01).","['patients infected with human immunodeficiency virus (HIV', 'HIV patients with compensated cirrhosis', '21 patients diagnosed with DLC and HIV infection']","['Liver stem cell therapy', 'Autologous bone marrow cell transplantation', 'bone marrow cell transplantation through the portal vein']","['total bilirubin level and prothrombin time', 'liver function score', 'levels of albumin', 'white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels', 'survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1258861', 'cui_str': 'Transplantation, Bone Marrow Cell'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}]","[{'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",21.0,0.0173503,"The white blood cell count, hemoglobin, platelet count, and CD4+ and CD8+ levels were significantly higher in the combination therapy group at different time points as compared to the routine therapy group (P<0.05 or <0.01).","[{'ForeName': 'Baochi', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Mingrong', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': ""Department of General Surgery, Jiangqiao Hospital of Jiading District, Jiading Branch of Shanghai First People's Hospital, Shanghai 201803, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': 'Department of Surgery, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Shijia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Key Laboratory of Stem Cell Biology, Institute of Health Sciences, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai 200031, China.'}]",Bioscience reports,['10.1042/BSR20191316']
1152,32521324,"Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.","OBJECTIVE


To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities.
METHODS


Prospective, randomized, controlled, open, 12-month trial (NCT02374749).
PARTICIPANTS


consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group).
MAIN OUTCOME


change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management).
RESULTS


502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
CONCLUSIONS AND RELEVANCE


This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.",2020,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
","['consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM', 'patients with axial spondyloarthritis', '502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y', 'young population of patients with axSpA']","['nurse-led program of systematic screening', 'nurse-led program', 'single-visit nurse-led program']",['weighted comorbidity management score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",502.0,0.0692749,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France. Electronic address: anna.molto@aphp.fr.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM, Paris France; Pitié Salpêtrière hospital, APHP, Rheumatology department, Paris, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, F-94010, Créteil, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, Toulouse, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale, Paris, France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU Brest, LabEx IGO, Brest, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.012']
1153,32521394,Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.,"OBJECTIVE


Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty.
PATIENTS AND METHODS


Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device.
RESULTS


VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups.
CONCLUSIONS


Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.",2020,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","['patients undergoing posterior spinal fusion surgery', 'Eighty patients who underwent posterior spinal fusion', 'patients undergoing posterior lumbar spinal fusion surgery']","['Perioperative magnesium sulfate infusion', 'magnesium and saline', 'magnesium', 'perioperative magnesium sulfate infusion']","['postoperative analgesia', 'intraoperative bleeding', 'Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen', 'morphine consumption', 'cell count, magnesium concentration and coagulation status', 'Morphine consumption', 'intraoperative blood loss', 'pain score', 'activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT', 'Cumulative PCA morphine consumption', 'intraoperative blood loss and postoperative analgesia', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",80.0,0.140799,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","[{'ForeName': 'Masih Ebrahimy', 'Initials': 'ME', 'LastName': 'Dehkordy', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Tavanaei', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Younesi', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khorasanizade', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza Azizi', 'Initials': 'HA', 'LastName': 'Farsani', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraee-Yazdani', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Saeed_o_yazdani@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105983']
1154,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1155,32340471,Assessment of immunogenicity from galcanezumab phase 3 trials in patients with episodic or chronic migraine.,"BACKGROUND


This analysis characterizes the immunogenicity profile of galcanezumab, a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and inhibits its activity, in phase 3 migraine trials.
METHODS


Immunogenicity data were analyzed from baseline and double-blind, placebo-controlled phases of the 3-month chronic migraine study REGAIN, the 6-month episodic migraine studies EVOLVE-1 and EVOLVE-2, and from baseline and open-label phases of the 12-month chronic and episodic migraine Study CGAJ. The incidence of baseline antidrug antibodies, treatment-emergent antidrug antibodies, neutralizing antidrug antibodies, and the effect of antidrug antibody titer on pharmacokinetics and pharmacodynamics were assessed. The relationship between antidrug antibody status and efficacy was explored using average change in monthly migraine headache days. Safety analyses assessed the potential relationship between treatment-emergent antidrug antibodies and hypersensitivity events or adverse events related to injection sites.
FINDINGS


Across studies, 5.9-11.2% of patients had baseline antidrug antibodies. The incidence of treatment-emergent antidrug antibodies was 2.6-12.4% in the galcanezumab group and 0.5-1.7% in the placebo group. The majority of treatment-emergent antidrug antibodies were detected approximately 3-6 months after first study drug dose. Overall, the observed antidrug antibody titer did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or galcanezumab efficacy. There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies.
INTERPRETATION


These data showed that immunogenicity did not impact galcanezumab concentrations, calcitonin gene-related peptide concentrations, or the efficacy and hypersensitivity profile of galcanezumab in patients with migraine.",2020,"There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies.
","['patients with episodic or chronic migraine', 'patients with migraine']","['galcanezumab', 'placebo']","['hypersensitivity events or adverse events', 'efficacy and hypersensitivity profile of galcanezumab', 'galcanezumab concentrations, calcitonin gene-related peptide concentrations, or galcanezumab efficacy', 'incidence of treatment-emergent antidrug antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0430344', 'cui_str': 'Allergy profile'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.0992328,"There was no evidence that hypersensitivity events or adverse events related to injection sites were mediated by treatment-emergent antidrug antibodies.
","[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Martinez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Hindiyeh', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Anglin', 'Affiliation': 'Eli Lilly Canada Inc, Toronto, ON, Canada.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Kalidas', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Hodsdon', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kielbasa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Moser', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garces', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420920642']
1156,32245747,Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615.,,2020,,[],['Mobile Closed-Loop Control'],[],[],"[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.138398,,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Kovatchev', 'Affiliation': ''}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': ''}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': ''}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': ''}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': ''}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Buckingham', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle', 'Affiliation': ''}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Mei Mei', 'Initials': 'MM', 'LastName': 'Church', 'Affiliation': ''}, {'ForeName': 'Vikash', 'Initials': 'V', 'LastName': 'Dadlani', 'Affiliation': ''}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': ''}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ''}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': ''}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': ''}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-er06']
1157,32501612,"Circulating adhesion molecules and associations with HbA1c, hypertension, nephropathy, and retinopathy in the Treatment Options for type 2 Diabetes in Adolescent and Youth study.","BACKGROUND


The Treatment Options for type 2 Diabetes in Adolescent and Youth study, a randomized clinical trial of three treatments for type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3 months after acute metabolic decomposition) in over half of the participants. Given that binding of mononuclear cells to vascular endothelium, initiated by cellular adhesion molecules and chemokines, is an early step in vascular injury, we sought to evaluate (a) changes in cellular adhesion molecule levels during the trial; (b) effect of diabetes treatment; and (c) association of markers with HbA1c, hypertension, hypercholesterolemia, nephropathy, and retinopathy.
METHODS


Participants (n = 515 of 699) that had baseline assessment of adhesion molecules (monocyte chemoattractant protein-1 [MCP-1], vascular cell adhesion marker [VCAM], intercellular adhesion marker [ICAM], and E-Selectin) and at least one other assessment, measured at month 12, 24, or 36, were included.
RESULTS


Over 1 to 3 years, significant increases in MCP-1 and decreases in VCAM (both P < .0001) concentrations were found; however, no significant interactions were identified with treatment group for any molecule. For every 1% increase in HbA1c, ICAM increased by 1.8%, VCAM by 1.5%, and E-selectin by 6.8% (all P < .0001). E-selectin increased by 3.7% and 4.2% for every 10 mm Hg increase in systolic and diastolic blood pressure, respectively (both P < .0001). ICAM was 10.2% higher and E-selectin was 15.5% higher in participants with microalbuminuria (both P < .01). There was no significant association of adhesion molecule levels with retinopathy.
CONCLUSION


Concentrations of cellular adhesion molecules rise with increasing HbA1c in youth with T2DM, and are associated with blood pressure and microalbuminuria, markers of vascular injury.",2020,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"['type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3\u2009months after acute metabolic decomposition) in over half of the participants', 'Participants (n\xa0']",[],"['E-selectin', 'adhesion molecules (MCP-1, VCAM, ICAM, and E-Selectin', 'systolic and diastolic blood pressure', 'HbA1c, ICAM', 'ICAM', 'MCP-1 and decreases in VCAM ']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",[],"[{'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",2.0,0.0525065,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"[{'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'Department of Diabetes and Endocrinology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Rachana D', 'Initials': 'RD', 'LastName': 'Shah', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': 'The Biostatistics Center, George Washington University, Rockville, Maryland, USA.'}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': 'Department of Diabetes and Endocrinology, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, California, USA.'}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Gubitosi-Klug', 'Affiliation': 'Department of Pediatric Endocrinology, Diabetes and Metabolism, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13062']
1158,32497599,"Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial.","OBJECTIVE


To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DESIGN: Prospective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial.
SETTING


Seven university hospitals in the Republic of Korea.
PARTICIPANTS


Patients (N=220) with poststroke upper limb spasticity.
INTERVENTIONS


All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group).
MAIN OUTCOME MEASURES


The primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention.
RESULTS


The primary outcome was found to be -1.32±0.69 and -1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures.
CONCLUSIONS


MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.",2020,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","['post-stroke upper limb spasticity treatment', '220 patients with post-stroke upper limb spasticity', 'Seven university hospitals in the Republic of Korea PARTICIPANTS', 'patients with post-stroke upper limb spasticity DESIGN']","['onabotulinum toxin A (Botox®', 'MT10107 (Coretox group) or onabotulinum toxin A (Botox group', 'MT10107 (Coretox®']","['modified Ashworth scale (MAS', 'adverse events, vital signs, physical examination findings, and laboratory test results', 'Efficacy and safety', 'MAS scores for all muscles and DAS scores', 'response rate, global assessment of treatment, and safety measures', 'change in wrist flexor spasticity', 'efficacy and safety', 'MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C4743433', 'cui_str': 'onabotulinum toxin A'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",220.0,0.288437,"Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference.","[{'ForeName': 'Junekyung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul.'}, {'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul. Electronic address: mhchun@amc.seoul.kr.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Ko', 'Affiliation': ""Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.""}, {'ForeName': 'Shi-Uk', 'Initials': 'SU', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul.'}, {'ForeName': 'Deog Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam.'}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': 'Department of Rehabilitation Medicine, Dongguk University Ilsan Hospital, Goyang.'}, {'ForeName': 'Yoon Ghil', 'Initials': 'YG', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Gangnam Severance Hospital Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.025']
1159,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995']
1160,32505866,"Compared to Facebook, Instagram use causes more appearance comparison and lower body satisfaction in college women.","The current experiment tested the effect of social media use on college women's appearance comparisons, mood, and body satisfaction. We randomly assigned 308 undergraduate women (aged 18-26) to use Facebook, use Instagram, or play a matching game (the control condition) on an iPad for seven minutes. Compared to the Facebook condition, Instagram users retrospectively reported spending more time viewing images or videos containing people. Participants in both the Facebook and Instagram conditions also retrospectively reported engaging in more appearance comparisons relative to those in the control condition, but Instagram users reported significantly more appearance comparisons than those in the Facebook condition. Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect. Results are consistent with previous research suggesting social media use influences body satisfaction and social comparison, and that Instagram may be a particularly harmful platform when it comes to body image because of its focus on photos over text.",2020,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[""college women's"", '308 undergraduate women (aged 18-26) to use', 'college women']","['Facebook, use Instagram, or play a matching game (the control condition']","['body satisfaction', 'appearance comparisons, mood, and body satisfaction']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",308.0,0.0383295,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Engeln', 'Affiliation': 'Department of Psychology, Northwestern University, United States. Electronic address: rengeln@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Loach', 'Affiliation': 'Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Imundo', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zola', 'Affiliation': 'Oxford Internet Institute, University of Oxford, United Kingdom.'}]",Body image,['10.1016/j.bodyim.2020.04.007']
1161,32514802,A Multicenter Phase 2 Trial to Evaluate the Efficacy of mFOLFOX6 + Cetuximab as Induction Chemotherapy to Achieve R0 Surgical Resection for Advanced Colorectal Liver Metastases (NEXTO Trial).,"BACKGROUND


The effect of cetuximab plus mFOLFOX on downsizing of the tumors for curative resection has yet to be assessed for patients with advanced colorectal liver metastases (CRLMs). This study aimed to assess the oncologic benefit of cetuximab plus mFOLFOX for wild-type KRAS patients with advanced CRLMs.
METHODS


In this multicenter phase 2 trial, patients with technically unresectable tumor and/or five or more CRLMs harboring wild-type KRAS were treated with mFOLFOX plus cetuximab. The patients were assessed for resectability after 4 treatments, and then every 2 months up to 12 treatments. Patients with resectable disease were offered surgery after a waiting period of 1 month. The primary end point of the study was the R0 resection rate. The secondary end points were safety, progression-free survival (PFS), and overall survival (OS). The study is registered with the University Hospital Medical Information Network-Clinical Trials Registry Clinical Trials Registry (no. C000007923).
RESULTS


Between 2012 and 2015, 50 patients from 13 centers were enrolled in this trial. Two patients were excluded because they had not received induction therapy. The 48 patients had a complete response rate of 0% and a partial response rate of 64.6%. For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred. During a median follow-up period of 31 months, the median OS for all the patients was calculated to be 41 months (95% confidence interval, 28-not reached). The 3-year OS rate was 59%.
CONCLUSION


For patients with advanced CRLMs harboring wild-type KRAS, cetuximab administered in combination with mFOLFOX yields high response rates, leading to significantly high R0 resection rates and favorable prognoses.",2020,"For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred.","['Two patients were excluded because they had not received induction therapy', 'patients with advanced colorectal liver metastases (CRLMs', 'Between 2012 and 2015', '50 patients from 13 centers were enrolled in this trial', 'wild-type KRAS patients with advanced CRLMs', 'patients with technically unresectable tumor and/or five or more CRLMs harboring wild-type KRAS', 'Patients with resectable disease']","['mFOLFOX plus cetuximab', 'cetuximab plus mFOLFOX', 'mFOLFOX6\u2009+\u2009Cetuximab']","['median OS', 'partial response rate', 'R0 resection rate', 'complete response rate', '3-year OS rate', 'safety, progression-free survival (PFS), and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",2.0,0.0996801,"For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred.","[{'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Mise', 'Affiliation': 'Department of Hepatobiliary Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto City, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan. kihase-tky@umin.ac.jp.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Saiura', 'Affiliation': 'Department of Hepatobiliary Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto City, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Oba', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yamamoto', 'Affiliation': 'National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Asahi General Hospital, Asahi, Japan.'}, {'ForeName': 'Tadatoshi', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Nihon University School of Medicine, Itabashi City, Japan.'}, {'ForeName': 'Yojiro', 'Initials': 'Y', 'LastName': 'Hashiguchi', 'Affiliation': 'Teikyo University School of Medicine, Itabashi City, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shibasaki', 'Affiliation': 'JCHO Tokyo Yamate Medical Center, Shinjuku City, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Sakamoto', 'Affiliation': 'Saitama Cancer Center Hospital, Ina, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Yamagata', 'Affiliation': 'JCHO Tokyo Shinjuku Medical Center, Shinjuku City, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Aoyanagi', 'Affiliation': 'Kohnodai Hospital, National Center for Global-Health and Medicine, Shinjuku City, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Kaneko', 'Affiliation': 'Toho University Faculty of Medicine, Ota City, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Koyama', 'Affiliation': 'JCHO Tokyo Takanawa Hospital, Minato City, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Miyagawa', 'Affiliation': 'Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Hepatobiliary Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto City, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nozawa', 'Affiliation': 'Colon and Rectal Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kokudo', 'Affiliation': 'Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}]",Annals of surgical oncology,['10.1245/s10434-020-08627-y']
1162,32516149,Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial: Erratum.,,2020,,['after Ambulatory Surgery'],['Olanzapine'],['Postdischarge Nausea and Vomiting'],"[{'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",,0.139129,,[],Anesthesiology,['10.1097/ALN.0000000000003438']
1163,32520644,Comparison of 10 vs. 20 min neuromuscular training for the prevention of lower extremity injuries in male youth football: A cluster randomised controlled trial.,"The aim of this study was to compare the effects of 20 min neuromuscular training with a programme of 10 min in youth football players. 342 (15.4 ± 1.7 years) male football players from 18 teams were included, and cluster-randomized by team into two intervention groups. Both groups performed an injury prevention programme twice a week over five months using the same exercises but a different duration. The first intervention group (INT10, n = 175) performed the programme for 10 min, the second intervention group (INT20, n = 167) for 20 min. Primary outcomes were lower extremity (LE) injuries. Secondary outcomes were injury type, severity, mechanism and compliance to the intervention. 13 teams with 185 players were included for final analysis. No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism. The results show that performing preventive exercises for 10 min is no less effective than 20 min in youth football players. Shorter training sessions can, therefore, be effectively used for injury prevention.
TRIAL REGISTRATION


DRKS00015282.",2020,"No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism.","['1.7\xa0years', 'male football players from 18 teams', 'youth football players', '13 teams with 185 players were included for final analysis', '342 (15.4\xa0±', 'male youth football']","['20\xa0min neuromuscular training', 'neuromuscular training']","['lower extremity (LE) injuries', 'incidence rate ratio of the lower extremities', 'injury type, severity, mechanism and compliance to the intervention', 'INT10']","[{'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C4517579', 'cui_str': '15.4'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0885356,"No significant group difference was found between INT10 (6.37 per 1000 h) and INT20 (7.20 per 1000 h) for the incidence rate ratio of the lower extremities (IRR = 1.03, 95% confidence interval 0.59, 1.79), nor for the distribution of injury location, type, severity or mechanism.","[{'ForeName': 'Anna Lina', 'Initials': 'AL', 'LastName': 'Rahlf', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sport Science, Friedrich Schiller University of Jena , Jena, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Department of Human Movement Science and Exercise Physiology, Institute of Sport Science, Friedrich Schiller University of Jena , Jena, Germany.'}]",Journal of sports sciences,['10.1080/02640414.2020.1776459']
1164,32530426,Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial.,"BACKGROUND


WHO recommends that men who have sex with men (MSM) receive gonorrhoea and chlamydia testing, but many evidence-based preventive services are unaffordable. The pay-it-forward strategy offers an individual a gift (eg, a test for sexually transmitted diseases) and then asks whether they would like to give a gift (eg, a future test) to another person. This study examined the effectiveness of a pay-it-forward programme to increase gonorrhoea and chlamydia testing among MSM in China.
METHODS


We did a randomised controlled superiority trial at three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China. We included MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing. Restricted randomisation was done using computer-generated permuted blocks. 30 groups were randomised into three arms (1:1:1): a pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing and then asked whether they would like to donate for testing of prospective participants, a pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing was offered at ¥150 (US$22). There was no masking to arm assignment. The primary outcome was gonorrhoea and chlamydia test uptake ascertained by administrative records. We used generalised estimating equations to estimate intervention effects with one-sided 95% CIs and a prespecified superiority margin of 20%. The trial is registered with ClinicalTrials.gov, NCT03741725.
FINDINGS


Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis. 101 were randomly assigned to the pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group. Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm. The estimated difference in test uptake between the pay-it-forward and standard-of-care group was 38·4% (95% CI lower bound 28·4%). Among men in the pay-it-forward arm, 54 of 57 (95%) chose to donate to support testing for others.
INTERPRETATION


The pay-it-forward strategy can increase gonorrhoea and chlamydia testing uptake among Chinese MSM and could be a useful tool for scaling up preventive services that carry a mandatory fee.
FUNDING


US National Institute of Health; Special Programme for Research and Training in Tropical Diseases, sponsored by UNICEF, UNDP, World Bank, and WHO; the National Key Research and Development Program of China; Doris Duke Charitable Foundation; and Social Entrepreneurship to Spur Health.",2020,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","['MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing', 'men who have sex with men in China', 'MSM in China', 'three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China', 'Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis', 'men who have sex with men (MSM']","['pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing', 'pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group', 'Pay-it-forward gonorrhoea and chlamydia testing', 'pay-it-forward programme', 'pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing']",['gonorrhoea and chlamydia test uptake'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",301.0,0.098425,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Tiange P', 'Initials': 'TP', 'LastName': 'Zhang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Loyola University Chicago Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, VIC, Australia; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forastiere', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA; Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Li', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Mi', 'Affiliation': 'Blued, Beijing, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Weizan', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vickerman', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK. Electronic address: jdtucker@med.unc.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30172-9']
1165,32533172,The Effects of a Vocabulary Intervention on Teaching Multiple-Meaning Words to Students Who Are d/Deaf and Hard of Hearing.,"Building vocabulary knowledge, especially breadth and depth of word meanings, is a crucial step in assisting students to read and comprehend print independently. A large body of research has documented the low reading achievement levels of a number of Deaf and hard-of-hearing (DHH) students. The goal of the present study was to examine the effects of a vocabulary intervention to teach 24 multiple-meaning words to fourth-grade DHH students in Saudi Arabia by utilizing a single-case experimental design (multiple probe design across participants). A total of 5 students with a profound hearing loss participated in the study. About 3 of 5 received the intervention, whereas two other students served as an additional control component and were administered the pretest and posttest only. The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention. In contrast, students who did not receive the intervention showed no significant improvement on the posttest.",2020,The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention.,"['Students', '24 multiple-meaning words to fourth-grade DHH students in Saudi Arabia by utilizing a single-case experimental design (multiple probe design across participants', '5 students with a profound hearing loss participated in the study']","['vocabulary intervention', 'Vocabulary Intervention']",['recognition and comprehension scores'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0018772', 'cui_str': 'Partial deafness'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5.0,0.0168948,The data showed that there was a significant improvement in the recognition and comprehension scores of students who received the intervention.,"[{'ForeName': 'Faisl M', 'Initials': 'FM', 'LastName': 'Alqraini', 'Affiliation': 'Prince Sattam bin Abdulaziz University.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Paul', 'Affiliation': 'The Ohio State University.'}]",Journal of deaf studies and deaf education,['10.1093/deafed/enaa015']
1166,32539224,Efficacy and safety of sodium-glucose co-transporter 2 inhibition according to left ventricular ejection fraction in DAPA-HF.,"AIMS


The aim of this study was to examine whether left ventricular ejection fraction (LVEF) modified efficacy and safety of dapagliflozin 10 mg compared with placebo in the 4744 patients with LVEF ≤40% randomized in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF).
METHODS AND RESULTS


We examined whether LVEF, analysed categorically or continuously, modified the effect of dapagliflozin. The primary efficacy outcome was the composite of a worsening heart failure (HF) event (unplanned HF hospitalization/an urgent HF visit requiring intravenous therapy) or cardiovascular death. Mean LVEF was 31.1% and LVEF categories analysed were: <26% (n = 1143), 26-30% (n = 1018), 31-35% (n = 1187), and >35% (n = 1396). Each 5% decrease in LVEF was associated with a higher risk of the primary outcome [hazard ratio (HR) 1.18; 95% confidence interval (CI) 1.13-1.24]. The benefit of dapagliflozin was consistent across the spectrum of LVEF: the dapagliflozin vs. placebo HR was 0.75 (95% CI 0.59-0.95) for LVEF <26%, 0.75 (0.57-0.98) for LVEF 26-30%, 0.67 (0.51-0.89) for LVEF 31-35%, and 0.83 (0.63-1.09) for LVEF >35% (P for interaction = 0.762). Similarly, the effect of dapagliflozin on the components of the primary endpoint was not modified by baseline LVEF (P for interaction for cardiovascular death = 0.974, and for worsening HF = 0.161). Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
CONCLUSION


Left ventricular ejection fraction was a significant predictor of hospitalization and mortality in patients with HF with reduced ejection fraction but did not modify the beneficial effect of dapagliflozin, overall or separately, in patients with and without diabetes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT03036124.",2020,"Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
",['4744 patients with LVEF\u2009≤40% randomized in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF'],"['sodium-glucose co-transporter 2 inhibition', 'dapagliflozin', 'LVEF', 'left ventricular ejection fraction (LVEF', 'placebo']","['hospitalization and mortality', 'LVEF', 'Mean LVEF', 'composite of a worsening heart failure (HF) event (unplanned HF hospitalization/an urgent HF visit requiring intravenous therapy) or cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4744.0,0.309689,"Safety of dapagliflozin was also consistent across the range of LVEF and neither efficacy nor safety were modified by diabetes status.
","[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'VA Medical Center, University of Minnesota, MN, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Charles University in Prague, Czech Republic.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Max Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute and Université de Montreal, Montreal, Canada.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Clinical Medicine, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc city, Vietnam.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1867']
1167,26805720,Behavioural recovery after treatment for varicose veins.,"BACKGROUND


The aim of this study was to assess behavioural recovery from the patient's perspective as a prespecified secondary outcome in a multicentre parallel-group randomized clinical trial comparing ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA) and surgery for the treatment of primary varicose veins.
METHODS


Participants were recruited from 11 UK sites as part of the CLASS trial, a randomized trial of UGFS, EVLA or surgery for varicose veins. Patients were followed up 6 weeks after treatment and asked to complete the Behavioural Recovery After treatment for Varicose Veins (BRAVVO) questionnaire. This is a 15-item instrument that covers eight activity behaviours (tasks or actions an individual is capable of doing in an idealized situation) and seven participation behaviours (what the individual does in an everyday, real-world situation) that were identified to be important from the patient's perspective.
RESULTS


A total of 798 participants were recruited. Both UGFS and EVLA resulted in a significantly quicker recovery compared with surgery for 13 of the 15 behaviours assessed. UGFS was superior to EVLA in terms of return to full-time work (hazard ratio 1·43, 95 per cent c.i. 1·11 to 1·85), looking after children (1·45, 1·04 to 2·02) and walks of short (1·48, 1·19 to 1·84) and longer (1·32, 1·05 to 1·66) duration.
CONCLUSION


Both UGFS and EVLA resulted in more rapid recovery than surgery, and UGFS was superior to EVLA for one-quarter of the behaviours assessed. The BRAVVO questionnaire has the potential to provide important meaningful information to patients about their early recovery and what they may expect to be able to achieve after treatment.",2016,Both UGFS and EVLA resulted in a significantly quicker recovery compared with surgery for 13 of the 15 behaviours assessed.,"['varicose veins', 'Participants were recruited from 11 UK sites as part of the CLASS trial', 'primary varicose veins', 'A total of 798 participants were recruited']","['UGFS and EVLA', 'UGFS', 'EVLA', 'ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA) and surgery', 'UGFS, EVLA or surgery for varicose veins']","['Behavioural recovery', 'behavioural recovery', 'Behavioural Recovery']","[{'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042345', 'cui_str': 'Varices'}]",[],798.0,0.128218,Both UGFS and EVLA resulted in a significantly quicker recovery compared with surgery for 13 of the 15 behaviours assessed.,"[{'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Cotton', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brittenden', 'Affiliation': 'Division of Applied Medicine, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Prior', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'School of Health Sciences, City University London, London, UK.'}]",The British journal of surgery,['10.1002/bjs.10081']
1168,32497956,Metacognitions about problematic Smartphone use: Development of a self-report measure.,"BACKGROUND AND AIMS


Recent research has suggested that metacognitions may play a role across the spectrum of addictive behaviours, including problematic use of technological devices. Metacognitions associated with problematic Smartphone use (PSU) have been scarcely investigated and measures to assess these beliefs are not yet available. The goal of the present study was: (i) to develop the first self-report scale of metacognitions about Smartphone use; and (ii) to investigate its predictive validity with respect to PSU.
METHODS


Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F = 66.2%; mean age: 28.08 ± 9.81; age range: 15-70). An exploratory factor analysis was first performed in a randomly allocated subsample of 350 participants. A confirmative factor analysis was then computed on a second subsample of 351 participants to test the fit of the factor structure identified.
RESULTS


Findings revealed a 3-factor solution consisting of positive metacognitions concerning emotional and cognitive regulation, positive metacognitions concerning social advantages, and negative metacognitions about uncontrollability and cognitive harm of Smartphone use. Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire (MSUQ) factors were significantly associated to PSU independently of anxiety and depressive symptoms.
CONCLUSIONS


The MSUQ might be a promising self-report measure and further support research into the role of metacognition in technological addictions.",2020,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"['350 participants', 'Twenty-four items concerning positive and negative metacognitions about PSU were framed and administered to a community sample of 701 Smartphone users (F\xa0=\xa066.2%; mean age: 28.08\xa0±\xa09.81; age range: 15-70']",[],"['anxiety and depressive symptoms', 'Metacognitions about Smartphone Use Questionnaire']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",701.0,0.0366231,Regression analysis showed that all the Metacognitions about Smartphone Use Questionnaire,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Casale', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy. Electronic address: silvia.casale@unifi.it.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Caponi', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Fioravanti', 'Affiliation': 'Department of Health Sciences, Psychology and Psychiatry Unit, University of Florence, via di San Salvi 12, Florence, Italy.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106484']
1169,32500733,Ambient Scent as a Positive Distraction in Long-Term Care Units: Theory of Supportive Design.,"AIM


This study was designed to explore the associations between an ambient scent environment and residents' wellness in long-term care facilities.
BACKGROUND


The number of older adults living in an institutional setting has been steadily but slowly increasing. Because of a higher chance of having psychological disorders among people living in institutional settings than people living in noninstitutional settings, providing a supportive institutional setting is critical to enhance their wellness. The theory of supportive design suggests healthcare facilities can lower people's stress levels via three conditions (i.e., perceived control, social support, and positive distractions).
METHOD


A single-blind and placebo-randomized controlled study investigated the impacts of ambient scent environment, as a positive distraction, on residents' depression levels. The recruited residents ( N  = 58) were randomly assigned into either the intervention group, which received a 1% dilution of lavender scent for 2 weeks nearby their bedside or the placebo group, which received a nonscent for 2 weeks.
RESULTS


Their depression levels were measured by the Geriatric Depression Scale. Based on the  t  tests, both intervention and placebo groups had improvement in depression, indicating a placebo effect of lavender scent. Further regression analyses explored the interaction effects of built environments (e.g., building, distance to a ventilation system, and square footage). However, no statistically significant impact of the built environment was found.
CONCLUSION


Despite a placebo effect of ambient scent environment and nonsignificant built environment on depression, this study has valuable implications of being a positive distraction during the healing process as developed by the Theory of Supportive design.",2020,"Based on the  t  tests, both intervention and placebo groups had improvement in depression, indicating a placebo effect of lavender scent.",['recruited residents ( N  = 58'],"['1% dilution of lavender scent for 2 weeks nearby their bedside or the placebo', 'placebo']","['depression levels', 'depression', 'Geriatric Depression Scale']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0031516', 'cui_str': 'Recognition odor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}]",58.0,0.119674,"Based on the  t  tests, both intervention and placebo groups had improvement in depression, indicating a placebo effect of lavender scent.","[{'ForeName': 'Suyeon', 'Initials': 'S', 'LastName': 'Bae', 'Affiliation': 'Department of Architectural Studies, 14716University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Abimbola O', 'Initials': 'AO', 'LastName': 'Asojo', 'Affiliation': 'Interior Design, Department of Design, Housing, and Apparel, 5635University of Minnesota, St. Paul, MN, USA.'}]",HERD,['10.1177/1937586720929021']
1170,32502311,Isolating adverse effects of glucocorticoids on the embryonic cardiovascular system.,"Antenatal glucocorticoid therapy reduces mortality in the preterm infant, but evidence suggests off-target adverse effects on the developing cardiovascular system. Whether deleterious effects are direct on the offspring or secondary to alterations in uteroplacental physiology is unclear. Here, we isolated direct effects of glucocorticoids using the chicken embryo, a model system in which the effects on the developing heart and circulation of therapy can be investigated, independent of effects on the mother and/or the placenta. Fertilized chicken eggs were incubated and divided randomly into control (C) or dexamethasone (Dex) treatment at day 14 out of the 21-day incubation period. Combining functional experiments at the isolated organ, cellular and molecular levels, embryos were then studied close to term. Chicken embryos exposed to dexamethasone were growth restricted and showed systolic and diastolic dysfunction, with an increase in cardiomyocyte volume but decreased cardiomyocyte nuclear density in the left ventricle. Underlying mechanisms included a premature switch from tissue accretion to differentiation, increased oxidative stress, and activated signaling of cellular senescence. These findings, therefore, demonstrate that dexamethasone treatment can have direct detrimental off-target effects on the cardiovascular system in the developing embryo, which are independent of effects on the mother and/or placenta.",2020,"Antenatal glucocorticoid therapy reduces mortality in the preterm infant, but evidence suggests off-target adverse effects on the developing cardiovascular system.",['Fertilized chicken eggs'],"['dexamethasone', 'Antenatal glucocorticoid therapy', 'dexamethasone (Dex', 'glucocorticoids']","['mortality', 'systolic and diastolic dysfunction']","[{'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}]",,0.0233044,"Antenatal glucocorticoid therapy reduces mortality in the preterm infant, but evidence suggests off-target adverse effects on the developing cardiovascular system.","[{'ForeName': 'Noor E W D', 'Initials': 'NEWD', 'LastName': 'Teulings', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Tessa A C', 'Initials': 'TAC', 'LastName': 'Garrud', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Youguo', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Skeffington', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beck', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Itani', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Fiona G', 'Initials': 'FG', 'LastName': 'Conlon', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Kimberley J', 'Initials': 'KJ', 'LastName': 'Botting', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Nicholas', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ashmore', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Blackmore', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Tong', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Camm', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jan B', 'Initials': 'JB', 'LastName': 'Derks', 'Affiliation': 'Department of Perinatal Medicine, University Medical Centre, Utrecht, Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': 'Medical Research Council Mitochondrial Biology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Murphy', 'Affiliation': 'Medical Research Council Mitochondrial Biology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ozanne', 'Affiliation': ""Institute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Dino A', 'Initials': 'DA', 'LastName': 'Giussani', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, UK.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.202000697R']
1171,32502443,"Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study.","BACKGROUND


Dual blockade of PD-L1 and VEGF has enhanced anticancer immunity through multiple mechanisms and augmented antitumour activity in multiple malignancies. We aimed to assess the efficacy and safety of atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF) in patients with unresectable hepatocellular carcinoma.
METHODS


GO30140 is an open-label, multicentre, multiarm, phase 1b study that enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide. The study included five cohorts, and the two hepatocellular carcinoma cohorts, groups A and F, are described here. Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1. In group A, all patients received atezolizumab (1200 mg) and bevacizumab (15 mg/kg) intravenously every 3 weeks. In group F, patients were randomly assigned (1:1) to receive intravenous atezolizumab (1200 mg) plus intravenous bevacizumab (15 mg/kg) every 3 weeks or atezolizumab alone by interactive voice-web response system using permuted block randomisation (block size of two) and stratification factors of geographical region; macrovascular invasion, extrahepatic spread, or both; and baseline α-fetoprotein concentration. Primary endpoints were confirmed objective response rate in all patients who received the combination treatment for group A and progression-free survival in the intention-to-treat population in group F, both assessed by an independent review facility according to Response Evaluation Criteria in Solid Tumors version 1.1. In both groups, safety was assessed in all patients who received at least one dose of any study treatment. This study is registered with ClinicalTrials.gov, NCT02715531, and is closed to enrolment.
FINDINGS


In group A, 104 patients were enrolled between July 20, 2016, and July 31, 2018, and received atezolizumab plus bevacizumab. With a median follow-up of 12·4 months (IQR 8·0-16·2), 37 (36%; 95% CI 26-46) of 104 patients had a confirmed objective response. The most common grade 3-4 treatment-related adverse events were hypertension (13 [13%]) and proteinuria (seven [7%]). Treatment-related serious adverse events occurred in 25 (24%) patients and treatment-related deaths in three (3%) patients (abnormal hepatic function, hepatic cirrhosis, and pneumonitis). In group F, 119 patients were enrolled and randomly assigned (60 to atezolizumab plus bevacizumab; 59 to atezolizumab monotherapy) between May 18, 2018, and March 7, 2019. With a median follow-up of 6·6 months (IQR 5·5-8·5) for the atezolizumab plus bevacizumab group and 6·7 months (4·2-8·2) for the atezolizumab monotherapy group, median progression-free survival was 5·6 months (95% CI 3·6-7·4) versus 3·4 months (1·9-5·2; hazard ratio 0·55; 80% CI 0·40-0·74; p=0·011). The most common grade 3-4 treatment-related adverse events in group F were hypertension (in three [5%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group) and proteinuria (in two [3%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group). Treatment-related serious adverse events occurred in seven (12%) patients in the atezolizumab plus bevacizumab group and two (3%) patients in the atezolizumab monotherapy group. There were no treatment-related deaths.
INTERPRETATION


Our study shows longer progression-free survival with a combination of atezolizumab plus bevacizumab than with atezolizumab alone in patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy. Therefore, atezolizumab plus bevacizumab might become a promising treatment option for these patients. This combination is being compared with standard-of-care sorafenib in a phase 3 trial.
FUNDING


F Hoffmann-La Roche/Genentech.",2020,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"['119 patients', 'patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy', 'unresectable hepatocellular carcinoma (GO30140', 'Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1', 'enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide', '104 patients were enrolled between July 20, 2016, and July 31, 2018, and received', 'patients with unresectable hepatocellular carcinoma']","['atezolizumab alone', 'intravenous atezolizumab (1200 mg) plus intravenous bevacizumab', 'atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF', 'atezolizumab', 'atezolizumab alone by interactive voice-web response system', 'Atezolizumab with or without bevacizumab', 'standard-of-care sorafenib', 'atezolizumab monotherapy', 'bevacizumab', 'atezolizumab plus bevacizumab']","['median progression-free survival', 'progression-free survival', 'efficacy and safety', 'serious adverse events', 'proteinuria', 'objective response rate', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",104.0,0.146586,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Stein', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Aiwu Ruth', 'Initials': 'AR', 'LastName': 'He', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Electronic address: kyunghunlee@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30156-X']
1172,32507672,"Corrigendum to 'Randomized, double-blind, placebo-controlled phase II study of istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer (CARRIE)': Annals of Oncology, Volume 31, Issue 1, 2020, Pages 79-87.",,2020,,"['2020, Pages 79-87']","['istiratumab (MM-141) plus nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine', 'placebo']",[],"[{'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}]","[{'cui': 'C3641662', 'cui_str': 'MM-141'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0987186,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundranda', 'Affiliation': 'Medical Oncology, Banner MD Anderson Cancer Center, Gilbert, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Gracian', 'Affiliation': 'Medical Oncology, Centro Integral Oncologico Clara Campal, Universidad CEU San Pablo, Madrid, Spain; Departamento de Ciencias Médicas Clínicas, Universidad CEU San Pablo, Madrid, Spain.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Zafar', 'Affiliation': 'Hematology and Oncology, Florida Cancer Specialists, Fort Myers, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meiri', 'Affiliation': 'Medical Oncology, Comprehensive Care and Research Center, Atlanta, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'GI Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Algül', 'Affiliation': 'TUM School of Medicine, Klinikum rechts der Isar, Medizinische Klinik II, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology, Hospital Universitario Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Ahn', 'Affiliation': 'Medical Oncology, Cancer Treatment Centers of America Chicago, Zion, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Watkins', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, Sutton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Charu', 'Affiliation': 'Hematology/Oncology, Pacific Cancer Medical Center, Anaheim, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zalutskaya', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kuesters', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Pipas', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Santillana', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Askoxylakis', 'Affiliation': 'Clinical Development, Merrimack Pharmaceuticals, Inc., Cambridge, USA.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'Hematology/Oncology, University of California San Francisco Cancer Center, San Francisco, USA. Electronic address: andrew.ko@ucsf.edu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.011']
1173,32505785,Effect of a 10-month residential multidisciplinary weight loss intervention on food reward in adolescents with obesity.,"BACKGROUND


While multidisciplinary weight loss (WL) programs have been suggested to improve the sensitivity of appetite control system, this study examined for the first time the effect of a specific multidisciplinary intervention on the hedonic aspects of food intake in adolescents with obesity.
STUDY DESIGN


Twenty-four adolescents (11-15 years) with obesity (mean BMI: 35.7 ± 4.5 kg/m 2 ; BMI percentile: 98.7 ± 0.5) took part in a 10-month inpatient WL program, which included physical activity, nutritional education and psychological support. Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits were assessed at baseline, 5 months and at the end of the 10-month intervention. Analyses were conducted with linear mixed models and paired t-tests.
RESULTS


The mean WL was 8.9 ± 6.9 kg. Appetite sensations and pre-meal hedonic ratings of liking for all food categories (HF: high-fat; LF: low-fat; SA: savory; SW: sweet) increased after 5 months (fasting hunger, p = 0.02; fasting desire to eat, p = 0.01; daily hunger, p = 0.001; pre-meal liking for HFSA, p = 0.03; LFSA, p = 0.04; HFSW, p = 0.009; LFSW, p = 0.005). In contrast, appetite sensations (fasting and daily), emotional eating (p < 0.001), uncontrolled eating (p = 0.009), and pre-meal explicit liking (for all food categories) decreased between months 5 and 10. Post-meal liking for HFSA (p < 0.001), LFSA (p = 0.002), HFSW (p = 0.02) and LFSW (p < 0.001) decreased between baseline and month 5 and remained unchanged between months 5 and 10.
CONCLUSION


These findings suggest that adaptive mechanisms to WL occurring in the short-to-medium term are attenuated in the longer term with the persistence of WL. These results indicate improvements in the reward response to food in adolescents with obesity and may contribute to the beneficial effect of multicomponent WL interventions in this population. Future studies are required to confirm these findings and elucidate underlying mechanisms.",2020,Post-meal liking for HFSA (p<0.001),"['adolescents with obesity', 'Twenty-four adolescents (11-15 years) with obesity']",['residential multidisciplinary weight loss intervention'],"['Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits', 'appetite sensations (fasting and daily), emotional eating (p<0.001), uncontrolled eating (p=0.009), and pre-meal explicit liking', 'HFSW', 'Appetite sensations and pre-meal hedonic ratings of liking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",24.0,0.0263658,Post-meal liking for HFSA (p<0.001),"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France. Electronic address: maud.miguet@neuro.uu.se.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Department of Human Nutrition, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112996']
1174,32511981,"Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Resistance to approved inhibitors of KIT proto-oncogene, receptor tyrosine kinase (KIT), and platelet-derived growth factor receptor α (PDGFRA) is a clinical challenge for patients with advanced gastrointestinal stromal tumours. We compared the efficacy and safety of ripretinib, a switch-control tyrosine kinase inhibitor active against a broad spectrum of KIT and PDGFRA mutations, with placebo in patients with previously treated, advanced gastrointestinal stromal tumours.
METHODS


In this double-blind, randomised, placebo-controlled, phase 3 study, we enrolled adult patients in 29 specialised hospitals in 12 countries. We included patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Eligible patients were randomly assigned (2:1) to receive either oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo group). Randomisation was done via an interactive response system using randomly permuted block sizes of six and stratified according to number of previous therapies and ECOG performance status. Patients, investigators, research staff, and the sponsor study team were masked to a patient's treatment allocation until the blinded independent central review (BICR) showed progressive disease for the patient. The primary endpoint was progression-free survival, assessed by BICR. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of study drug. Patients randomly assigned to placebo were permitted to cross over to ripretinib 150 mg at the time of disease progression. The INVICTUS study is registered with ClinicalTrials.gov, number NCT03353753, and with WHO International Clinical Trials Registry Platform, number EUCTR2017-002446-76-ES; follow-up is ongoing.
FINDINGS


Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients were randomly assigned to receive either ripretinib (n=85) or placebo (n=44). At data cutoff (May 31, 2019), at a median follow-up of 6·3 months (IQR 3·2-8·2) in the ripretinib group and 1·6 months (1·1-2·7) in the placebo group, 51 patients in the ripretinib group and 37 in the placebo group had had progression-free survival events. In the double-blind period, median progression-free survival was 6·3 months (95% CI 4·6-6·9) with ripretinib compared with 1·0 months (0·9-1·7) with placebo (hazard ratio 0·15, 95% CI 0·09-0·25; p<0·0001). The most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events in the ripretinib group (n=85) included lipase increase (four [5%]), hypertension (three [4%]), fatigue (two [2%]), and hypophosphataemia (two (2%]); in the placebo group (n=43), the most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events were anaemia (three [7%]), fatigue (one [2%]), diarrhoea (one [2%]), decreased appetite (one [2%]), dehydration (one [2%]), hyperkalaemia (one [2%]), acute kidney injury (one [2%]), and pulmonary oedema (one [2%]). Treatment-related serious adverse events were reported in eight (9%) of 85 patients who received ripretinib and three (7%) of 43 patients who received placebo. Treatment-related deaths occurred in one patient in the placebo group (septic shock and pulmonary oedema) and one patient in the ripretinib group (cause of death unknown; the patient died during sleep).
INTERPRETATION


Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
FUNDING


Deciphera Pharmaceuticals.",2020,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
","['enrolled adult patients in 29 specialised hospitals in 12 countries', 'patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2', 'patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments', 'Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients', 'patients with previously treated, advanced gastrointestinal stromal tumours', 'patients with advanced gastrointestinal stromal tumours (INVICTUS', 'patients with advanced gastrointestinal stromal tumours', 'Eligible patients']","['ripretinib', 'oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo', 'placebo']","['lipase increase', 'median progression-free survival', 'progression-free survival events', 'intention-to-treat population and safety', 'fatigue', 'hyperkalaemia', 'acute kidney injury', 'septic shock and pulmonary oedema', 'diarrhoea', 'dehydration', 'serious adverse events', 'pulmonary oedema', 'hypertension', 'deaths', 'decreased appetite', 'progression-free survival, assessed by BICR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549475', 'cui_str': 'Lipase increased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.788248,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments.
","[{'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France; Headquarters, Unicancer, Paris, France; LYRICAN, Lyon, France; Faculte Lyon Est, Université Claude Bernard, Lyon, France. Electronic address: jean-yves.blay@lyon.unicancer.fr.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Serrano', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine, Portland VA Health Care System, Portland, OR, USA; OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology and Preventative Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen, Essen, Germany; German Consortium for Translational Cancer Research (DKTK), Partner Site Essen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Leuven Cancer Institute and Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, The Royal Marsden NHS Foundation Trust, London, UK; Division of Clinical Studies, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Department of Oncology, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Meade', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ruiz-Soto', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Department of Hematology and Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30168-6']
1175,32512067,Comparison of the Biocidal Efficacy of Sodium Dichloroisocyanurate and Calcium Hydroxide as Intracanal Medicaments over a 7-Day Contact Time: An Ex Vivo Study.,"INTRODUCTION


The use of medicaments has been recommended for the treatment of root canal infection. This study evaluated the antimicrobial effect of a well-known biocidal agent, sodium dichloroisocyanurate (NaDCC), by comparing it with calcium hydroxide [Ca(OH) 2 ] using an engineered 3-species biofilm root canal model.
METHODS


Thirty-eight human single-rooted teeth were decoronated and chemomechanically prepared before inoculation using Enterococcus faecalis, Actinomyces viscosus, and Streptococcus mutans using a flow cell model for 4 weeks for biofilm formation. The samples were randomly divided into 3 groups: NaDCC (n = 12), Ca(OH) 2  (n = 12), and positive control (no medicament, n = 14). The medicaments were placed using a Lentulo spiral. After a contact time of 7 days, the roots were crushed and plated on selective media. Bacterial identities were confirmed with the use of selective media. Colony-forming units were calculated (CFU/ml). Descriptive statistics (mean and standard deviations) were calculated.
RESULTS


Seven-day dressing with NaDCC or Ca(OH) 2  presented with no growth. For the positive control, the mean colony-forming units were 2.97E4 ± 3.42E4 (CFU/ml). All previously inoculated strains were recovered in the control group.
CONCLUSIONS


NaDCC and Ca(OH) 2  when used as intracanal medicaments were able to eradicate an engineered 3-species biofilm in single-rooted teeth in an ex vivo model. NaDCC deserves further investigation as an intracanal medicament.",2020,"CONCLUSIONS


NaDCC and Ca(OH) 2  when used as an intracanal medicaments were able to eradicate an engineered three-species biofilm in single-rooted teeth, ex-vivo model.",['ology: 38 human single-rooted teeth'],"['NaDCC or Ca(OH', 'calcium hydroxide (Ca(OH', 'sodium dichloroisocyanurate and calcium hydroxide', 'well-known biocidal agent, sodium dichloroisocyanurate (NaDCC', 'Ca(OH) 2  (n=12) and positive control (no medicament', 'NaDCC']",['Descriptive statistics [mean and standard deviations (SD'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0142834', 'cui_str': 'Sodium dichloroisocyanurate'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456386', 'cui_str': 'Medicament'}]","[{'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",,0.0118599,"CONCLUSIONS


NaDCC and Ca(OH) 2  when used as an intracanal medicaments were able to eradicate an engineered three-species biofilm in single-rooted teeth, ex-vivo model.","[{'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Chan', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Neelika Roy', 'Initials': 'NR', 'LastName': 'Chowdhury', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia; Private Practice, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zilm', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Rossi-Fedele', 'Affiliation': 'Adelaide Dental School, University of Adelaide, South Australia, Australia. Electronic address: giampiero.rossi-fedele@adelaide.edu.au.'}]",Journal of endodontics,['10.1016/j.joen.2020.05.011']
1176,32521287,Evaluating the actual and perceived effectiveness of E-cigarette prevention advertisements among adolescents.,"BACKGROUND


The efficacy of e-cigarette prevention ads among adolescents has seldom been studied. We examined the impact of ads from the The Real Cost vaping prevention media campaign on what adolescents think and believe about vaping. We also sought to test whether perceived message effectiveness (PME) served as a proxy for ad impact.
METHODS


Participants were 543 U.S. adolescents ages 13-17. In an online experiment, we randomized participants to either: 1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition). Participants in each condition viewed 2 videos in a random order. After ad exposure, the survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape.
RESULTS


The FDA's The Real Cost ads led to higher beliefs about the harms of vaping (p < .001), more negative attitudes toward vaping (p < .001), and lower intentions to vape (p < .05) compared to the control videos. The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos. Effects perceptions were associated with all three outcomes (all ps < 0.001, adjusting for both types of PME and covariates), but message perceptions did not offer additional predictive value.
CONCLUSIONS


Exposure to The Real Cost vaping prevention ads gave adolescents a more negative view of vaping and lowered their intentions to vape compared to control videos. Effects perceptions may be superior to message perceptions as a proxy for e-cigarette prevention ad impact.",2020,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"['Participants were 543 U.S. adolescents ages 13-17', 'adolescents']","[""1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition"", 'E-cigarette prevention advertisements']","['survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]",543.0,0.0210644,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"[{'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: noar@email.unc.edu.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Rohde', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Prentice-Dunn', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kresovich', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106473']
1177,32523873,A blended cognitive behavioral intervention for patients with adjustment disorder with anxiety: A randomized controlled trial.,"Adjustment disorder with anxiety (ADA) is a common psychiatric pathology worldwide, but it is often undertreated. Cognitive behavioral therapy (CBT) is the first-line treatment, but very few studies have been carried out for the treatment of ADA. Internet-delivered CBT (iCBT) appears to be an effective treatment option, with the potential to reach a larger proportion of individuals suffering from ADA. Guidance is a beneficial feature of iCBT, provided in most studies by email or telephone (traditional guided iCBT). Blended CBT, which combines an online intervention and therapeutic guidance provided in person (face-to-face), could be a way to benefit from both the advantages of face-to-face CBT regarding human interactional quality and the advantages of internet-based CBT in terms of improved access to treatment. In this randomized controlled trial, the effectiveness of two forms of administration of  Seren@ctif , a 5-week CBT program for patients with ADA according the DSM-5, was examined: one delivered through face-to-face sessions (face-to-face CBT) and the other delivered online and guided with face-to-face contact with a nurse (blended CBT); these formats were compared with a wait-list control group (WLC). A total of 120 patients were included and randomized to one of these three conditions. Measures were administered before treatment, after treatment and 6 months after inclusion in the study. Both treatment conditions displayed significant decreases in anxiety, depression, worry and perceived stress at posttreatment when compared to the WLC group. The decrease in symptoms was mostly maintained 6 months after inclusion for the two experimental groups. Blended CBT showed significantly greater reductions in anxiety and depression than did face-to-face CBT on some secondary outcome measures. We conclude that both face-to-face CBT and blended CBT are effective treatments for patients with ADA, and we suggest that blended CBT may be slightly more effective than classical face-to-face CBT. Trial Registration: Clinicaltrials.gov NCT02621775;https://clinicaltrials.gov/ct2/show/NCT02621775(Archived by WebCite at http://www.webcitation.org/6tQrkPs1u).",2020,Blended CBT showed significantly greater reductions in anxiety and depression than did face-to-face CBT on some secondary outcome measures.,"['patients with ADA according the DSM-5', 'A total of 120 patients', 'patients with adjustment disorder with anxiety', 'patients with ADA', 'Adjustment disorder with anxiety (ADA']","['Internet-delivered CBT (iCBT', 'Seren@ctif , a 5-week CBT program', 'blended cognitive behavioral intervention', 'online and guided with face-to-face contact with a nurse (blended CBT); these formats were compared with a wait-list control group (WLC', 'Cognitive behavioral therapy (CBT', 'Blended CBT']","['anxiety, depression, worry and perceived stress', 'anxiety and depression', 'symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154587', 'cui_str': 'Adjustment disorder with anxious mood'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",120.0,0.0349629,Blended CBT showed significantly greater reductions in anxiety and depression than did face-to-face CBT on some secondary outcome measures.,"[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Leterme', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1172 - LilNCog - Lille Neuroscience & Cognition, F-59000 Lille, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Behal', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Demarty', 'Affiliation': ""Univ. Lille, Inserm, CHU Lille, CIC1403 - Centre d'Investigation Clinique, F-59000 Lille, France.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Barasino', 'Affiliation': 'Stress and Anxiety Unit, Department of Psychiatry, Lille University Hospital, Lille, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rougegrez', 'Affiliation': 'Stress and Anxiety Unit, Department of Psychiatry, Lille University Hospital, Lille, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS: évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vaiva', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1172 - LilNCog - Lille Neuroscience & Cognition, F-59000 Lille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Servant', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, U1172 - LilNCog - Lille Neuroscience & Cognition, F-59000 Lille, France.'}]",Internet interventions,['10.1016/j.invent.2020.100329']
1178,32524895,Adding video-debriefing to Helping-Babies-Breathe training enhanced retention of neonatal resuscitation knowledge and skills among health workers in Uganda: a cluster randomized trial.,"BACKGROUND


Skilled birth attendants must be competent to provide prompt resuscitation to save newborn lives at birth. Both knowledge and skills (competence) decline with time after training but the optimal duration for refresher training among frontline-skilled birth attendants in low-resource settings is unknown.
OBJECTIVES


We assessed the effect of an innovative Helping-Babies-Breathe simulation-based teaching method using video-debriefing compared to standard Helping-Babies-Breathe training on 1) neonatal resuscitation knowledge and skills attainment and 2) competence retention among skilled birth attendants in Northern Uganda.
METHODS


A total of 26 health facilities with 86 birth attendants were equally randomised to intervention and control arms. The 2nd edition of the American Association of Pediatrics Helping-Babies-Breathe curriculum was used for training and assessment. Knowledge and skills were assessed pre- and post-training, and during follow-up at 6 months. A mixed effects linear regression model for repeated measures was used to assess the short and long-term effects of the intervention on neonatal resuscitation practices while accounting for clustering.
RESULTS


Eighty-two (95.3%) skilled birth attendants completed follow-up at 6 months. Approximately 80% of these had no prior Helping-Babies-Breathe training and 75% reported practicing neonatal resuscitation routinely. Standard Helping-Babies-Breathe training with video-debriefing improved knowledge and skills attainment post-training [adjusted mean difference: 5.34; 95% CI: 0.82-10.78] and retention [adjusted mean difference: 2.97; 95% CI: 1.52-4.41] over 6 months post-training compared to standard training after adjusting for confounding and clustering. Factors that reduced knowledge and skills retention among birth attendants were monthly resuscitation of one neonate or more and being in service for more than 5 years.
CONCLUSION


Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda. However, more research is needed to justify the proposed intervention in this context.",2020,Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda.,"['A total of 26 health facilities with 86 birth attendants', 'skilled birth attendants in Northern Uganda', 'health workers in Uganda']","['innovative Helping-Babies-Breathe simulation-based teaching method using video-debriefing compared to standard Helping-Babies-Breathe training on 1) neonatal resuscitation knowledge and skills attainment and 2) competence retention', 'video-debriefing to standard Helping-Babies-Breathe training']",['knowledge and skills retention'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0374356,Adding video-debriefing to standard Helping-Babies-Breathe training had an effect on birth attendants' competence attainment and retention over 6 months in Uganda.,"[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Odongkara', 'Affiliation': 'Department of Paediatrics and Child Health, Gulu University Faculty of Medicine , Gulu, Uganda.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pejovic', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Vincentina', 'Initials': 'V', 'LastName': 'Achora', 'Affiliation': 'Department of Paediatrics and Child Health, Gulu University Faculty of Medicine , Gulu, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mukunya', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ndeezi', 'Affiliation': 'College of Health Sciences, School of Medicine, Department of Paediatrics and Child Health, Makerere University , Kampala, Uganda.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'College of Health Sciences, School of Medicine, Department of Paediatrics and Child Health, Makerere University , Kampala, Uganda.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Nankabirwa', 'Affiliation': 'Center for International Health, University of Bergen , Bergen, Norway.'}]",Global health action,['10.1080/16549716.2020.1743496']
1179,32524912,Improving the Wellbeing of Female Prisoners via Psychological Skills Training: A Feasibility Study.,"Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population. The integration of positive psychological interventions in offender supervision has received recent advocacy. The aim of the current pre-post pilot study was to determine the short-term effects of group-based resilience training on mental health outcomes for female offenders and explore intervention acceptability. Offenders ( n  = 24) self-selected to partake in a multi-component psychological skill program based on positive psychology, cognitive-behavioural therapy, and mindfulness-based activities. The training was taught in nine sessions of 1.5 hr each. Baseline and follow-up measurements of mental wellbeing and psychological distress were collected and focus groups conducted to investigate participants' experiences, acceptability, and appropriateness of the training. Moderate to large effect sizes indicating significant improvements were observed for wellbeing,  g  = 0.75 and distress,  g  = 0.56. Training was well received by participants and staff and was delivered feasibly within the prison context. The results are encouraging, and a future well-powered study using a rigorous controlled design is warranted.",2020,Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population.,"['female offenders', 'Female Prisoners via Psychological Skills Training', 'Offenders ( n \u2009=\u200924) self-selected to partake in a multi-component psychological skill program based on positive psychology, cognitive-behavioural therapy, and mindfulness-based activities']",['group-based resilience training'],"['rates of mental disorders and lower mental wellbeing', 'mental health outcomes', 'mental wellbeing and psychological distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0242408,Prisoners display significantly higher rates of mental disorders and lower mental wellbeing than the general population.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lo', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Iasiello', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'van Agteren', 'Affiliation': 'Wellbeing and Resilience Centre, Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, Australia.'}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X20928029']
1180,32527941,Comparing Circulating Tumor Cell Counts with Dynamic Tumor Size Changes as Predictor of Overall Survival: A Quantitative Modeling Framework.,"PURPOSE


Quantitative relationships between treatment-induced changes in tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS), are lacking. We present a population modeling framework identifying and quantifying such relationships, based on longitudinal data collected in patients with metastatic colorectal cancer (mCRC) to evaluate the value of tumor size and CTC counts as predictors of OS.
EXPERIMENTAL DESIGN


A pharmacometric approach (i.e., population pharmacodynamic modeling) was used to characterize the changes in tumor size and CTC count and evaluate them as predictors of OS in 451 patients with mCRC treated with chemotherapy and targeted therapy in a prospectively randomized phase III study (CAIRO2).
RESULTS


A tumor size model of tumor quiescence and drug resistance was used to characterize the tumor size time-course, and was, in addition to the total normalized dose (i.e., of all administered drugs) in a given cycle, related to the CTC counts through a negative binomial model (CTC model). Tumor size changes did not contribute additional predictive value when the mean CTC count was a predictor of OS. Treatment reduced the typical mean count from 1.43 to 0.477 (HR = 3.94). The modeling framework was applied to explore whether dose modifications (increased and reduced) would result in a CTC count below 1/7.5 mL after 1 to 2 weeks of treatment.
CONCLUSIONS


Time-varying CTC counts can be useful for early predicting OS in patients with mCRC, and may therefore have potential for model-based treatment individualization. Although tumor size was connected to CTC, its link to OS was weaker.",2020,Treatment reduced the typical mean count from 1.43 to 0.477 (HR= 3.94).,"['patients with mCRC', 'patients with metastatic colorectal cancer (mCRC', '451 patients with mCRC treated with']",['chemotherapy and targeted therapy'],"['tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS', 'typical mean count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",451.0,0.0171847,Treatment reduced the typical mean count from 1.43 to 0.477 (HR= 3.94).,"[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Netterberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Leon W M M', 'Initials': 'LWMM', 'LastName': 'Terstappen', 'Affiliation': 'Department of Medical Cell BioPhysics, Faculty of Science and Technology, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Lena E', 'Initials': 'LE', 'LastName': 'Friberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. lena.friberg@farmbio.uu.se.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2570']
1181,32527972,Endovascular treatment in older adults with acute ischemic stroke in the MR CLEAN Registry.,"OBJECTIVE


To explore clinical outcomes in older adults with acute ischemic stroke treated with endovascular thrombectomy (EVT).
METHODS


We included consecutive patients (2014-2016) with an anterior circulation occlusion undergoing EVT from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry. We assessed the effect of age (dichotomized at ≥80 years and as continuous variable) on the modified Rankin Scale (mRS) score at 90 days, symptomatic intracranial hemorrhage (sICH), and reperfusion rate. The association between age and mRS was assessed with multivariable ordinal logistic regression, and a multiplicative interaction term was added to the model to assess modification of reperfusion by age on outcome.
RESULTS


Of the 1,526 patients, 380 (25%) were ≥80 years of age (referred to here as older adults). Older adults had a worse functional outcome than younger patients (adjusted common odds ratio [acOR] for an mRS score shift toward better outcome 0.31, 95% confidence interval [CI] 0.24-0.39). Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19). There were no differences in proportion of patients with mRS scores of 4 to 5, sICH, or reperfusion rates. Successful reperfusion was more strongly associated with a shift toward good functional outcome in older adults than in younger patients (acOR 3.22, 95% CI 2.04-5.10 vs 2.00, 95% CI 1.56-2.57,  p   interaction  = 0.026).
CONCLUSION


Older age is associated with an increased absolute risk of poor clinical outcome, while the relative benefit of successful reperfusion seems to be higher in these patients. These results should be taken into consideration in the selection of older adults for EVT.",2020,"Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19).","['older adults with acute ischemic stroke treated with endovascular thrombectomy (EVT', 'Older adults', 'consecutive patients (2014-2016) with an anterior circulation occlusion undergoing EVT from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry', 'older adults with acute ischemic stroke in the MR CLEAN Registry', '1,526 patients, 380 (25%) were ≥80 years of age (referred to here as older adults']",['Endovascular treatment'],"['proportion of patients with mRS scores of 4 to 5, sICH, or reperfusion rates', 'Mortality', 'modified Rankin Scale (mRS) score at 90 days, symptomatic intracranial hemorrhage (sICH), and reperfusion rate', 'functional outcome']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.144124,"Mortality was also higher in older adults (51% vs 22%, adjusted odds ratio 3.12, 95% CI 2.33-4.19).","[{'ForeName': 'Adrien E', 'Initials': 'AE', 'LastName': 'Groot', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Ivo G H', 'Initials': 'IGH', 'LastName': 'Jansen', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Hinsenveld', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'van de Graaf', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Hanna C', 'Initials': 'HC', 'LastName': 'Willems', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Schonewille', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Marquering', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van den Berg', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Department of Neurology (A.E.G., Y.B.W.E.M.R., J.M.C.), Department of Radiology and Nuclear Medicine (K.M.T., I.G.H.J., H.A.M., R.v.d.B., C.B.L.M.M.), Department of Internal Medicine (H.C.W.), Geriatrics Section, and Department of Biomedical Engineering and Physics (H.A.M.), Amsterdam UMC, University of Amsterdam; Department of Public Health (H.F.L.), Department of Neurology (R.A.v.d.G., B.R., D.W.J.D.), and Department of Radiology and Nuclear Medicine (R.A.v.d.G., B.R.), Erasmus MC University Medical Center, Rotterdam; Department of Neurology (W.H.), Maastricht University Medical Center; and Department of Neurology (W.J.S.), Sint Antonius Hospital Nieuwegein, the Netherlands. j.coutinho@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009764']
1182,32528046,Author Correction: Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat'],"['Placebo', 'Author Correction: Vitamin D Supplementation']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],,0.30447,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-020-67064-9']
1183,32536538,Palatal needle-free anesthesia for upper molars extraction. A randomized clinical trial.,"BACKGROUND


The aim of this study was to compare the ability of liposomal and non-liposomal lidocaine and prilocaine in hydrogel formulations to promote topical anesthesia in palatal mucosa during upper molar extractions.
METHODS


In this randomized, cross over, triple-blinded clinical trial, a liposomal and a non-liposomal formulation of the eutectic mixture of local anesthetics, 2.5% lidocaine and 2.5% prilocaine, were used to promote palatal anesthesia without the local anesthetic infiltration during bilateral upper molars extractions.
RESULTS


From the total of 40 patients included in this study, the non-liposomal eutectic lidocaine-prilocaine formulation failed in 40% of cases, unlike the liposomal formulation, which was effective for all patients (Fisher's exact test, p < 0.0001). Furthermore, the liposomal formulation (26.75 ± 7,47 min) induced longer anesthesia duration (t-test, p < 0.0001) than the non-liposomal formulation (16.78 ± 4.75 min). No mucosal ulceration or discomfort was reported for both formulations.
CONCLUSION


The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration. For the first time, a topical formulation allowed upper molars surgical removal without injection of any local anesthetic agent into palatal mucosa in adults.",2020,"The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration.","['palatal mucosa during upper molar extractions', 'adults']","['liposomal and a non-liposomal formulation of the eutectic mixture of local anesthetics, 2.5% lidocaine and 2.5% prilocaine', 'Palatal needle-free anesthesia', 'liposomal and non-liposomal lidocaine and prilocaine', 'lidocaine-prilocaine']","['longer anesthesia duration', 'mucosal ulceration or discomfort']","[{'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0236053', 'cui_str': 'Mucosal ulcer'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",40.0,0.116154,"The liposomal formulation was able to induce adequate anesthesia in palatal mucosa during dental extraction, avoiding the local anesthetic infiltration.","[{'ForeName': 'Klinger de Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil. Electronic address: klinger.amorim@outlook.com.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Franz-Montan', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Bruno Vilela', 'Initials': 'BV', 'LastName': 'Muniz', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'Jaiza Samara Macena de', 'Initials': 'JSM', 'LastName': 'Araújo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, 13414-903, Piracibaba, São Paulo, Brazil.'}, {'ForeName': 'José Vânison Ferreira', 'Initials': 'JVF', 'LastName': 'Santana', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}, {'ForeName': 'Anne Caroline Gercina Carvalho', 'Initials': 'ACGC', 'LastName': 'Dantas', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}, {'ForeName': 'Eneida', 'Initials': 'E', 'LastName': 'de Paula', 'Affiliation': 'Biochemistry and Tissue Biology Department, Biology Institute, University of Campinas, St Monteiro Lobato 255, 13083-862, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Liane Maciel de Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Federal University of Sergipe, Oral Surgery and Anesthesiology Area of Dentistry Department, St Cláudio Batista, 49060-108, Aracaju, Cidade Nova, Sergipe, Brazil.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.05.001']
1184,32547649,"Corrigendum to ""Khorana score and thromboembolic risk in stage II-III colorectal cancer patients: a post hoc analysis from the adjuvant TOSCA trial"".",[This corrects the article DOI: 10.1177/1758835919899850.].,2020,[This corrects the article DOI: 10.1177/1758835919899850.].,['stage II-III colorectal cancer patients'],[],[],"[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.030732,[This corrects the article DOI: 10.1177/1758835919899850.].,[],Therapeutic advances in medical oncology,['10.1177/1758835920932317']
1185,32544297,Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2.,"BACKGROUND


N8-GP (turoctocog alfa pegol; Esperoct ®  , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard FVIII products. pathfinder2 (NCT01480180) was a multi-national, open-label trial of N8-GP in previously treated adolescent and adult patients with severe hemophilia A.
OBJECTIVE


We report end-of-trial efficacy and safety of N8-GP from pathfinder2.
METHODS


pathfinder2 main phase and extension phase part 1 results have been previously reported. During extension phase part 2, patients could switch from N8-GP prophylaxis 50 IU/kg every fourth day (Q4D) or 75 IU/kg once weekly (Q7D), depending on bleeding status. Extension phase part 2 collected long-term safety and efficacy data for all regimens until trial end (first patient in main phase, 30 January 2012; trial end, 10 December 2018).
RESULTS


Overall, 186 patients were exposed to N8-GP for up to 6.6 years (median 5.4 years). The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm. Nearly 30% of patients experienced zero bleeds throughout the entire duration of the trial, the hemostatic response was 83.2% across all treatment arms, and patient-reported outcomes were maintained or slightly improved. No safety concerns were detected.
CONCLUSION


Data from the completed pathfinder2 trial, one of the largest and longest-running clinical trials to investigate treatment of severe hemophilia A, demonstrate the efficacy and safety of N8-GP in previously treated adolescent and adult patients.",2020,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"['previously treated adults and adolescents with hemophilia A', 'previously treated adolescent and adult patients', '186 patients were exposed to N8-GP for up to 6.6\xa0years (median 5.4\xa0years', 'previously treated adolescent and adult patients with severe hemophilia A']",['N8-GP'],"['hemostatic response', 'annualized bleeding rate (ABR']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",186.0,0.0938106,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Giangrande', 'Affiliation': 'Department of Clinical and Laboratory Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Faraizah', 'Initials': 'F', 'LastName': 'Abdul Karim', 'Affiliation': 'National Blood Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Nemes', 'Affiliation': 'National Hemophilia Center and Hemostasis Department, Medical Center of the Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'Chur Woo', 'Initials': 'CW', 'LastName': 'You', 'Affiliation': 'Pediatric Department, Eulji University Hospital, Daejeon, Korea.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Landorph', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Milan S', 'Initials': 'MS', 'LastName': 'Geybels', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Curry', 'Affiliation': 'Oxford Haemophilia and Thrombosis Centre and Oxford National Institute for Health Research Biomedical Research Centre, Churchill Hospital, Oxford, UK.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14959']
1186,32544361,Immunogenicity of an  Escherichia coli -produced bivalent human papillomavirus vaccine under different vaccination intervals.,"A new  Escherichia coli -produced human papillomavirus (HPV)-16/18 vaccine has been shown to be safe and highly efficacious and was recently licensed in China. As a post hoc analysis of the phase III trial, this study aimed to assess the impact of vaccination time deviations on the specific antibody response and guide the better usage of this vaccine in the real world. A total of 3689 healthy women aged 18-45 years old were randomly assigned to receive the bivalent HPV-16/18 vaccine according to a 0-, 1- and 6-month schedule with a wide vaccination interval. The first vaccination interval between the 1 st  and 2 nd  doses (the 1 st  interval) was divided into three groups: 28-40 d, 41-50 d and 51-60 d. The second vaccination interval between the 2 nd  and 3 rd  doses (the 2 nd  interval) was divided into three groups: 103-139 d, 140-160 d and 161-198 d. The reverse cumulative curves for the IgG of the three groups with different 1 st  vaccination intervals or with different 2 nd  vaccination intervals at month 7 almost overlapped for both HPV-16 and HPV-18. Compared with the standard vaccination schedule (a 1 st  interval of 28-40 d and a 2 nd  interval of 140-160 d) subgroup, all the subgroups had GMC ratios greater than 0.83, with the lower limit of 95% CIs higher than 0.64. In conclusion, a slight deviation in the vaccination time of the 2 nd  and 3 rd  doses has only a minor, insignificant impact on the immune response induced by the  Escherichia coli -produced HPV-16/18 vaccine.",2020,The reverse cumulative curves for the IgG of the three groups with different 1 st  vaccination intervals or with different 2 nd  vaccination intervals at month 7 almost overlapped for both HPV-16 and HPV-18.,"['Escherichia coli -produced bivalent human papillomavirus vaccine under different vaccination intervals', '3689 healthy women aged 18-45\xa0years old']",['bivalent HPV-16/18 vaccine'],"['Immunogenicity', 'GMC ratios']","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C1721788', 'cui_str': 'human papillomavirus vaccine, L1 type 16, 18'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}]",3689.0,0.0525128,The reverse cumulative curves for the IgG of the three groups with different 1 st  vaccination intervals or with different 2 nd  vaccination intervals at month 7 almost overlapped for both HPV-16 and HPV-18.,"[{'ForeName': 'Xiao-Juan', 'Initials': 'XJ', 'LastName': 'Yu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Bi-Zhen', 'Initials': 'BZ', 'LastName': 'Lin', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'You-Lin', 'Initials': 'YL', 'LastName': 'Qiao', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention , Nanjing, Jiangsu, China.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Rong-Cheng', 'Initials': 'RC', 'LastName': 'Li', 'Affiliation': 'Center for Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention , Nanning, Guangxi, China.'}, {'ForeName': 'Wei-Dan', 'Initials': 'WD', 'LastName': 'Huang', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Vaccine R&D Department, Xiamen Innovax Biotech Company , Xiamen, Fujian, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics(SCIBP), School of Public Health, Xiamen University , Xiamen, Fujian, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1761202']
1187,32153031,Attempting Randomized Housing First Research in a Community Context: Reflections on Failure.,"The Housing First (HF) model of permanent supportive housing for individuals experiencing chronic homelessness has a strong evidence base that has largely been driven by researchers in the field of community psychology in partnership with community-based organizations. However, important gaps in the HF literature remain. Implementing rigorous research designs to further the evidence for HF requires immense resources to fund both the housing intervention and the research activities. In the absence of such resources, university-community partnerships may be established to integrate research within business-as-usual services and utilize existing housing units. This first person account presents a ""post-mortem"" exploration of an attempt to conduct a randomized trial of scattered-site and single-site approaches to HF within a community context from the perspectives of multiple stakeholders involved in the endeavor. Despite strengths of the research collaborative, the project did not come to completion due to a series of both insurmountable and avoidable barriers. Yet, the experience illuminated several potential challenges researchers and housing providers conducting work in this area may encounter, such as ever-changing homeless service system policies that may impact research and organizational procedures. Lessons learned and recommendations for preventing or overcoming systems-level barriers and potential challenges within the university-community partnership are described.",2020,The Housing First (HF) model of permanent supportive housing for individuals experiencing chronic homelessness has a strong evidence base that has largely been driven by researchers in the field of community psychology in partnership with community-based organizations.,['individuals experiencing chronic homelessness'],[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}]",[],[],,0.030349,The Housing First (HF) model of permanent supportive housing for individuals experiencing chronic homelessness has a strong evidence base that has largely been driven by researchers in the field of community psychology in partnership with community-based organizations.,"[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'DePaul University, Chicago, IL, USA.'}, {'ForeName': 'Anh-Dao', 'Initials': 'AD', 'LastName': 'Tran', 'Affiliation': 'DePaul University, Chicago, IL, USA.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': 'DePaul University, Chicago, IL, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fay', 'Affiliation': 'Downtown Emergency Service Center, Seattle, WA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Malone', 'Affiliation': 'Downtown Emergency Service Center, Seattle, WA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fyall', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Tsemberis', 'Affiliation': 'Pathways Housing First Institute, Los Angeles, CA, USA.'}]",American journal of community psychology,['10.1002/ajcp.12421']
1188,32202231,Effects of nicotine on microvascular responsiveness after nicotine satiety versus overnight nicotine abstinence.,,2020,,[],['nicotine'],['microvascular responsiveness'],[],"[{'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",,0.0330574,,"[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruseghini', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Capelli', 'Affiliation': 'Department of Physical Performances, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Baraldo', 'Affiliation': 'Department of Medicine, University of Udine, Udine, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Chiamulera', 'Affiliation': 'Neuropsychopharmacology Lab, Department of Diagnostic and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zandonai', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behaviour Research Centre, Faculty of Psychology, University of Granada, Granada, Spain.'}]","Vascular medicine (London, England)",['10.1177/1358863X20906029']
1189,32502564,What Is the Impact of Engaging With Natural Environments Delivered Via Virtual Reality on the Psycho-emotional Health of People With Spinal Cord Injury Receiving Rehabilitation in Hospital? Findings From a Pilot Randomized Controlled Trial.,"OBJECTIVES


This study investigated (1) the effect of engaging with 20-minute simulated natural environments delivered via virtual reality (VR) on current mood state and (2) the effect of engaging with multiple VR sessions over a period of a week on the depressive symptoms of people with a spinal cord injury (SCI).
DESIGN


Randomized controlled trial design.
SETTING


Spinal Cord Injury Rehabilitation Unit in Australia.
PARTICIPANTS


Participants (N=24) were assigned to a group engaging in VR sessions during week 1 (group 1, n=10) or week 2 (group 2, n=14).
INTERVENTIONS


The intervention week involved participation in up to three 20-minute VR sessions over 3 consecutive days. The control condition involved regular rehabilitation practice over a week.
MAIN OUTCOME MEASURES


The Patient Health Questionnaire-8 (PHQ-8) was completed prior to the first week (T1), after the first week and prior to the second week (T2), and after the second week (T3). Current feeling states, including depressed/happy, anxious/relaxed, and not feeling good/feeling good, were rated immediately prior and after each VR session.
RESULTS


Levels of happiness, relaxation, and feeling good were significantly higher subsequent to engaging with each VR session. Between-group differences in PHQ-8 scores were significantly greater for participants who experienced the intervention during the first week compared to participants within the control group: intervention participants had significant improvements in psycho-emotional health. Within-group PHQ-8 scores were reduced for each group subsequent to experiencing the intervention; however, differences were not significant.
CONCLUSIONS


Engaging with simulated natural environments delivered via VR can favorably affect the psycho-emotional health of people with SCI receiving rehabilitation in hospital. Future research including larger samples and investigating the effect over a longer time period is required to confirm the findings presented.",2020,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","['people with SCI receiving rehabilitation in hospital', 'Spinal Cord Injury Rehabilitation Unit in Australia', 'Participants (n=24', 'people with spinal cord injury receiving rehabilitation in hospital']","['engaging with 20 minute simulated natural environments delivered via virtual reality (VR', 'group engaging in VR sessions', 'natural environments delivered via virtual reality', 'engaging with multiple VR sessions']","['Levels of happiness, relaxation, and feeling good', 'psycho-emotional health', 'Patient Health Questionnaire-8 (PHQ-8', 'PHQ-8 scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0204101', 'cui_str': 'Spinal cord injury rehabilitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0557745', 'cui_str': 'Natural environment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0262716,"Within-group PHQ-8 scores reduced for each group subsequent to experiencing the intervention, however differences were not significant.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Lakhani', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria; Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland. Electronic address: a.lakhani@latrobe.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland; Occupational Therapy Department, PA Hospital, Metro South Health Division of Rehabilitation, Woolloongabba, Queensland.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Occupational Therapy Department, PA Hospital, Metro South Health Division of Rehabilitation, Woolloongabba, Queensland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mallison', 'Affiliation': 'Western Sydney University, Penrith, New South Wales.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grimbeek', 'Affiliation': 'Upper Brookfield, Brisbane, Queensland.'}, {'ForeName': 'Izak', 'Initials': 'I', 'LastName': 'Hollins', 'Affiliation': 'Hopkins Centre, Menzies Health Institute Queensland, Griffith University, Meadowbrook, Queensland.'}, {'ForeName': 'Col', 'Initials': 'C', 'LastName': 'Mackareth', 'Affiliation': 'Spinal Life Australia, Woolloongabba, Queensland, Australia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.013']
1190,32504314,Analysis of C. difficile infection-related outcomes in European participants in the bezlotoxumab MODIFY I and II trials.,"The MODIFY I/II trials demonstrated that bezlotoxumab, a human monoclonal antibody against Clostridioides difficile toxin B, given during antibiotic treatment for Clostridioides difficile infection (CDI) significantly reduced C. difficile recurrence (rCDI) in adults at high risk for rCDI. Efficacy of CDI-directed intervention may depend on ribotype regional epidemiology, and patient characteristics. This post hoc analysis assessed the efficacy of bezlotoxumab in the subgroup of MODIFY I/II trial participants enrolled in Europe. Data from the bezlotoxumab (10 mg/kg single intravenous infusion) and placebo (0.9% saline) groups from MODIFY I/II were compared to assess initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality through 12 weeks post-infusion. Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48%). Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%). Fifty-five percent of participants were female, and 86% were hospitalized at randomization. The rate of ICC was similar between treatment groups. The rate of rCDI in the bezlotoxumab group was lower compared with placebo among European participants overall, and among those with ≥ 1 risk factor for rCDI. Bezlotoxumab reduced 30-day CDI-associated rehospitalizations compared with placebo. These results are consistent with overall results from the MODIFY trials and demonstrate that bezlotoxumab reduces rCDI and CDI-associated rehospitalizations in European patients with CDI. MODIFY I/II (NCT01241552 and NCT01513239).",2020,"Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%).","['Fifty-five percent of participants were female, and 86% were hospitalized at randomization', 'adults at high risk for rCDI', 'Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48', 'European participants in the bezlotoxumab MODIFY I and II trials', 'European patients with CDI', 'subgroup of MODIFY I/II trial participants enrolled in Europe']","['bezlotoxumab', 'CDI-directed intervention', 'Bezlotoxumab', 'placebo']","['initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality', 'rate of rCDI', 'rate of ICC', '30-day CDI-associated rehospitalizations']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}]","[{'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}]",1554.0,0.572207,"Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%).","[{'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Bouza', 'Affiliation': 'University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Cornely', 'Affiliation': 'Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM); Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD); Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ramos-Martinez', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plesniak', 'Affiliation': 'University of Rzeszów Medical Center, Łańcut, Poland.'}, {'ForeName': 'Misoo C', 'Initials': 'MC', 'LastName': 'Ellison', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Hanson', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. mary.beth.dorr@merck.com.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-020-03935-3']
1191,32518012,A multimodality triage algorithm to improve cytoreductive outcomes in patients undergoing primary debulking surgery for advanced ovarian cancer: A Memorial Sloan Kettering Cancer Center team ovary initiative.,"OBJECTIVE


To describe outcomes using a multimodal algorithm to triage patients with advanced epithelial ovarian cancer (EOC) to primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT).
METHODS


All patients with EOC treated at our institution from 04/2015-08/2018 were identified. We included patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score. A low risk score for suboptimal cytoreduction was defined as ≤6, and a high risk score ≥7. Patients were triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score.
RESULTS


Among 299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score. For patients with a low risk score, management included laparotomy/PDS, 181 (80%); LSC, 43 (19%) (with subsequent triage: PDS, 31; NACT, 12); and NACT, 2 (1%). For patients with a high risk score, management included laparotomy/PDS, 9 (12%); LSC, 51 (70%) (with subsequent triage: PDS, 28; NACT, 23); and NACT, 13 (18%). Overall, 83% underwent PDS, with a 75% CGR rate and 94% optimal cytoreduction rate. Use of the algorithm resulted in a 31% LSC rate and a 6% rate of suboptimal PDS.
CONCLUSIONS


The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.",2020,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","['triage patients with advanced epithelial ovarian cancer (EOC', 'patients undergoing primary debulking surgery for advanced ovarian cancer', '299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score', 'All patients with EOC treated at our institution from 04/2015-08/2018 were identified', 'patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score']",['primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT'],"['cytoreductive outcomes', 'triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score']","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",299.0,0.0508146,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","[{'ForeName': 'Alli M', 'Initials': 'AM', 'LastName': 'Straubhar', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Olga T', 'Initials': 'OT', 'LastName': 'Filippova', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Renee A', 'Initials': 'RA', 'LastName': 'Cowan', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lakhman', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Nikolovski', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Torrisi', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Weining', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Ginger J', 'Initials': 'GJ', 'LastName': 'Gardner', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sonoda', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Long Roche', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA. Electronic address: longrock@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.041']
1192,32527382,"Treatment of Alcohol Dependence in Primary Care Compared With Outpatient Specialist Treatment: Twelve-Month Follow-Up of a Randomized Controlled Trial, With Trajectories of Change.","OBJECTIVE


The purpose of this study was to investigate if brief treatment for alcohol dependence in primary care with the 15-method was as effective as specialist addiction care. In addition, we sought to investigate trajectories for change of alcohol consumption.
METHOD


This study was a randomized controlled noninferiority trial, between-groups parallel design, with a noninferiority limit of 50 g of alcohol per week. A total of 288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic. The primary outcome was change in weekly alcohol consumption at the 12-month follow-up. Secondary outcomes were heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers. Trajectories were investigated using change in World Health Organization drinking risk levels.
RESULTS


The intention-to-treat analysis (n = 231) showed that the estimated weekly alcohol consumption in primary care was 18.2 g (95% CI [14.9, 51.3]) higher compared with specialist care (p = .28). Noninferiority was not demonstrated as the confidence interval exceeded the noninferiority limit. The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment. The analyses of trajectories showed the main part of change in consumption occurred from baseline to the 6-month follow-up and was maintained to the 12-month follow-up.
CONCLUSIONS


Although noninferiority could not be demonstrated, based on similar trajectories and sustained reduction of alcohol use, this study indicates brief treatment of alcohol dependence in primary care with the 15-method is a feasible and promising approach.",2020,The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment.,['288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic'],['Outpatient Specialist Treatment'],"['change in weekly alcohol consumption', 'change in consumption', 'heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",288.0,0.0610297,The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallhed Finn', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andréasson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hammarberg', 'Affiliation': 'Department of Clinical Neurosciences, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}]",Journal of studies on alcohol and drugs,[]
1193,32527389,Effects of Age and Acute Moderate Alcohol Consumption on Electrophysiological Indices of Attention.,"OBJECTIVE


Despite increased attention to risks and benefits associated with moderate drinking lifestyles among aging adults, relatively few empirical studies focus on acute alcohol effects in older drinkers. Using electroencephalographic indices of early attention modulation (P1 and N1) and later stimulus processing (P3), we investigated whether acute alcohol consumption at socially relevant doses differentially influences neurocognitive performance in older, relative to younger, moderate drinkers.
METHOD


Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers were randomly assigned to receive one of three alcohol doses (placebo, .04 g/dl, or .065 g/dl target breath alcohol concentrations). Repeated-measures analysis of variance examined the effects of age, alcohol dose concentration, and their potential interaction on P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task.
RESULTS


Age-specific effects on P1 amplitudes varied by instruction set, with alcohol-associated decreases in amplitude among older drinkers in response to task-relevant stimuli and increases to irrelevant stimuli, F(2, 141) = 2.70, p = .07, η p 2  = .04. In contrast, N1 analyses demonstrated alcohol-related latency reductions among older, relative to younger, adults, F(2, 83) = 3.42, p = .04. Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) = 5.73, p < .01, η p 2  = .08.
CONCLUSIONS


Our results underscore the impact of acute moderate alcohol consumption on attentional functioning, highlighting age-dependent sensitivity in electrophysiological indices of early attentional processing. Given the import of attentional functioning to quality of life and increases in drinking among a rapidly expanding aging population, these findings have broad public health relevance.",2020,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","['older drinkers', 'older, relative to younger, moderate drinkers', 'Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers']","['early attention modulation (P1 and N1) and later stimulus processing (P3', 'alcohol doses (placebo, .04']",['P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337677', 'cui_str': 'Moderate drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",87.0,0.0715192,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","[{'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'University of Florida Center for Addiction Research & Education, Gainesville, Florida.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}]",Journal of studies on alcohol and drugs,[]
1194,32533948,Corneal Topography Raw Data Classification Using a Convolutional Neural Network.,"PURPOSE


We investigated the efficiency of a convolutional neural network applied to corneal topography raw data to classify examinations of 3 categories: normal, keratoconus (KC), and history of refractive surgery (RS).
DESIGN


Retrospective machine-learning experimental study.
METHODS


A total of 3,000 Orbscan examinations (1,000 of each class) of different patients of our institution were selected for model training and validation. One hundred examinations of each class were randomly assigned to the test set. For each examination, the raw numerical data from ""elevation against the anterior best fit sphere (BFS),"" ""elevation against the posterior BFS"" ""axial anterior curvature,"" and ""pachymetry"" maps were used. Each map was a square matrix of 2,500 values. The 4 maps were stacked and used as if they were 4 channels of a single image.A convolutional neural network was built and trained on the training set. Classification accuracy and class wise sensitivity and specificity were calculated for the validation set.
RESULTS


Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%). Sensitivity and specificity were, respectively, 100% and 100% for KC, 100% and 99% (94.9%-100%) for normal examinations, and 98% (97.4%-100%) and 100% for RS examinations.
CONCLUSION


Using combined corneal topography raw data with a convolutional neural network is an effective way to classify examinations and probably the most thorough way to automatically analyze corneal topography. It should be considered for other routine tasks performed on corneal topography, such as refractive surgery screening.",2020,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"['3,000 Orbscan examinations (1000 of each class) of different patients of our institution were selected for model training and validation', '100 examinations of each class']",[],"['Classification accuracy and class wise sensitivity and specificity', 'Sensitivity and specificity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],"[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0443956,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Zéboulon', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France. Electronic address: pierrezeboulon@gmail.com.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Debellemanière', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Bouvet', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gatinel', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France; CEROC (Center of Expertise and Research in Optics for Clinicians), Paris, France.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.005']
1195,32543415,"Load bearing capacity and Weibull characteristics of inlay-retained resin-bonded fixed dental prosthesis made of all-ceramic, fiber-reinforced composite and metal-ceramic after cyclic loading.","PURPOSE


The objectives of this study were to evaluate the load bearing capacity of RBFDPs made of different materials after cyclic loading, and classify the failure types after loading.
MATERIALS AND METHODS


Sound human mandibular first premolars and first molar pairs (N = 60 per tooth type, n = 10 per group) were randomly divided into six experimental groups to receive one of the following inlay-retained RBFDP types: RC: Resin composite only, DFRC: Direct E-glass fiber-reinforced composite (FRC), IFRC: Indirect E-glass FRC, LS: Lithium disilicate glass-ceramic, ZR: Yttria-stabilized tetragonal zirconia, MC: Metal-ceramic. Box preparations were made in abutment teeth using diamond burs followed by standardized ultrasonic burs. The teeth were conditioned employing an etch-and-rinse adhesive system and the indirect RBFDPs were cemented adhesively. The specimens were subjected to cyclic loading for x1.200.000 in distilled water alternating between 5 and 55 °C (Zurich Chewing Simulator). They were then loaded to failure from the occlusal surface in the Universal Testing Machine (cross-head speed: 1 mm/min). Failure types were classified as repairable or irreparable depending on the location and size. Data were analyzed using Welch and Tamhane's T2 post-hoc tests (α = 0.05). Weibull modulus for each group was calculated based on parametric distribution analysis of censored data for maximum fracture load.
RESULTS


Mean load bearing capacity (N) of Groups LS (1274 ± 270), ZR (1567 ± 363) and MC (1544 ± 787) were significantly higher than those of other groups (p < 0.05). RC, DFRC, IFRC (601 ± 130 - 819 ± 270) and MC did not show significant difference (p > 0.05). Weibull modulus (m) was the highest in Group LS (m = 5.3) followed by Group RC (m = 5.1). Other groups presented Weibull moduli ranging between 1.4 and 3.3. Only in Group ZR, 2 early debonding occurred during cyclic loading. While in this group predominantly irreparable failures (debonding with without tooth fracture) were observed (8 out of 10), all other groups presented mainly single or a combination of repairable failures (chipping in the veneering material). DFRC, IDRC and MC did not show any debonding from the abutment teeth.
CONCLUSION


Considering load bearing capacity, repairable failure types and Weibull moduli, lithium disilicate seem to be more durable than those of other material options for posterior inlay-retained RBFDPs. Due to early debondings and catastrophic irreparable failure types, zirconia RBFDPs should be indicated with caution in the posterior region.",2020,"Considering load bearing capacity, repairable failure types and Weibull moduli, lithium disilicate seem to be more durable than those of other material options for posterior inlay-retained RBFDPs.","['Sound human mandibular first premolars and first molar pairs ', 'N\xa0=\xa060 per tooth type, n\xa0']","['Yttria-stabilized tetragonal zirconia, MC: Metal-ceramic', 'RBFDP types: RC: Resin composite only, DFRC: Direct E-glass fiber-reinforced composite (FRC), IFRC: Indirect E-glass FRC, LS: Lithium disilicate glass-ceramic, ZR']","['RC, DFRC, IFRC', 'DFRC, IDRC and MC', 'Mean load bearing capacity (N']","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1567733', 'cui_str': 'yttria stabilized tetragonal zirconia'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1568204', 'cui_str': 'IFNAR1 protein, human'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C1568204', 'cui_str': 'IFNAR1 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1318107', 'cui_str': 'Load-Bearing'}]",,0.059044,"Considering load bearing capacity, repairable failure types and Weibull moduli, lithium disilicate seem to be more durable than those of other material options for posterior inlay-retained RBFDPs.","[{'ForeName': 'Kim-Chi', 'Initials': 'KC', 'LastName': 'Brunner', 'Affiliation': 'University of Zürich, Center for Dental and Oral Medicine, Division of Dental Biomaterials, Clinic for Reconstructive Dentistry, Zurich, Switzerland.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'University of Zürich, Center for Dental and Oral Medicine, Division of Dental Biomaterials, Clinic for Reconstructive Dentistry, Zurich, Switzerland. Electronic address: mutluozcan@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103855']
1196,32546645,Neutrophil-to-Lymphocyte Ratio as a Prognostic Factor of Disease-free Survival in Postnephrectomy High-risk Locoregional Renal Cell Carcinoma: Analysis of the S-TRAC Trial.,"PURPOSE


In the S-TRAC trial, adjuvant sunitinib improved disease-free survival (DFS) compared with placebo in patients with locoregional renal cell carcinoma (RCC) at high risk of recurrence. This  post hoc  exploratory analysis investigated the neutrophil-to-lymphocyte ratio (NLR) for predictive and prognostic significance in the RCC adjuvant setting.
EXPERIMENTAL DESIGN


Kaplan-Meier estimates and Cox proportional analyses were performed on baseline NLR and change from baseline at week 4 to assess their association with DFS. Univariate  P  values were two-sided and based on an unstratified log-rank test.
RESULTS


609 of 615 patients had baseline NLR values; 574 patients had baseline and week 4 values. Sunitinib-treated patients with baseline NLR <3 had longer DFS versus placebo (7.1 vs. 4.7; HR, 0.71;  P  = 0.02). For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03;  P  = 0.91). A ≥25% NLR decrease at week 4 was associated with longer DFS versus no change (6.8 vs. 5.3 years; HR, 0.71;  P  = 0.01). A greater proportion of sunitinib-treated patients had ≥25% NLR decrease at week 4 (71.2%) versus placebo (17.4%). Patients with ≥25% NLR decrease at week 4 received a higher median cumulative sunitinib dose (10,137.5 mg) versus no change (8,168.8 mg) or ≥25% increase (6,712.5 mg).
CONCLUSIONS


In the postnephrectomy high-risk RCC patient cohort, low baseline NLR may help identify those most suitable for adjuvant sunitinib. A ≥25% NLR decrease at week 4 may be an early indicator of those most likely to tolerate treatment and derive DFS benefit.",2020,"For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91).",['patients with loco-regional renal cell carcinoma (RCC) at high risk of recurrence'],['placebo'],"['neutrophil-to-lymphocyte ratio (NLR', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.276738,"For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91).","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'London, United Kingdom. anuppatel666@gmail.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Pantuck', 'Affiliation': 'Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'University Hospital of Munich, Munich, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Pfizer Inc, La Jolla, California.'}, {'ForeName': 'Mariajose', 'Initials': 'M', 'LastName': 'Lechuga', 'Affiliation': 'Pfizer S.r.L, Milan, Italy.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Pfizer Inc, La Jolla, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0704']
1197,32543979,Participant experiences of change in mindfulness-based stress reduction for anxiety disorders.,"AIM


To explore experiences of change among participants in a randomized clinical trial of mindfulness-based stress reduction (MBSR) for anxiety disorders.
METHOD


Semi-structured interviews were conducted to explore the subjective experiences of change for individuals with anxiety disorders after a course in MBSR. Interviews were analysed employing hermeneutic-phenomenological thematic analysis.
RESULTS


Five main themes were identified: 1) Something useful to do when anxiety appears, 2) Feeling more at ease, 3) Doing things my anxiety wouldn't let me, 4) Meeting what is there, and 5) Better-but not there yet. Most participants used what they had learned for instrumental purposes, and described relief from anxiety and an increased sense of personal agency. A few reported more radical acceptance of anxiety, as well as increased self-compassion.
CONCLUSION


Participants of MBSR both describe mindfulness as a tool to ""fix"" anxiety and as bringing about more fundamental change towards acceptance of their anxiety. The complexity of reported change corresponds with better handling of areas representing known transdiagnostic features of anxiety disorder, such as dysfunctional cognitive processes (including attentional biases), emotional dysregulation, avoidance behaviours, and maladaptive self-relatedness. This supports MBSR as a transdiagnostic approach to the treatment of anxiety disorders.",2020,"Participants of MBSR both describe mindfulness as a tool to ""fix"" anxiety and as bringing about more fundamental change towards acceptance of their anxiety.","['Five main themes were identified', 'Semi-structured interviews', 'individuals with anxiety disorders after a course in MBSR']",['mindfulness-based stress reduction (MBSR'],['radical acceptance of anxiety'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0275636,"Participants of MBSR both describe mindfulness as a tool to ""fix"" anxiety and as bringing about more fundamental change towards acceptance of their anxiety.","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schanche', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Vøllestad', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Per-Einar', 'Initials': 'PE', 'LastName': 'Binder', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Aslak', 'Initials': 'A', 'LastName': 'Hjeltnes', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Dundas', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}, {'ForeName': 'Geir Høstmark', 'Initials': 'GH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Psychology, University of Bergen , Bergen, Norway.'}]",International journal of qualitative studies on health and well-being,['10.1080/17482631.2020.1776094']
1198,32557180,"The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England.","INTRODUCTION


Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect-free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current practice to see which reduces side-effect expectations whilst maintaining informed consent and credibility.
METHODS


We commissioned Ipsos MORI to conduct an online survey of 16- to 75-year-olds in England. 1067 people completed the study and were randomised to receive a PIL for a hypothetical new antibiotic that either communicated side-effects following current practice (n = 356), used positive framing with natural frequencies (n = 356), or positive framing with percentages (n = 355). After reading the leaflet, participants completed measures of their side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet.
RESULTS


Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure. Pairwise comparisons showed no difference in side-effect expectations between the two positively framed PILs (ps > 0.626). The positively framed PIL using natural frequencies produced more accurate risk perceptions than the same leaflet using percentages; but performed equally to the current PIL. There was no difference between the leaflets in terms of satisfaction with or credibility of the PILs.
CONCLUSION


Positively framed PILs using natural frequencies significantly reduced side-effect expectations and provided the most accurate risk perceptions without impacting satisfaction or credibility. Replication is needed with patients prescribed new medication and those with lower educational status.",2020,"Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure.","['16- to 75-Year-Olds in England', '1067 people completed the study']",[],"['side-effect expectations', 'satisfaction with or credibility of the PILs', 'side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet', 'accurate risk perceptions']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",1067.0,0.0810552,"Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure.","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Webster', 'Affiliation': 'Department of Psychology, University of Sheffield, Cathedral Court, 1 Vicar Lane, Sheffield, UK. r.k.webster@sheffield.ac.uk.'}, {'ForeName': 'G James', 'Initials': 'GJ', 'LastName': 'Rubin', 'Affiliation': ""Department of Psychological Medicine, King's College London, Institute of Psychiatry, Psychology and Neuroscience, Weston Education Centre, Denmark Hill, London, UK.""}]",Drug safety,['10.1007/s40264-020-00959-8']
1199,32554380,"Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial.","BACKGROUND


A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (eg, mindfulness meditation and cognitive behavioral therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by CBT constructs and featuring online videos, discussion forums, and videoconferencing, was developed to target depression, anxiety, and experiences of excess stress among university students.
OBJECTIVE


The aim of this study was to assess the effectiveness of an 8-week web-based mindfulness and CBT program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university.
METHODS


An RCT was designed to assess undergraduate students (n=160) who were randomly allocated to a web-based guided mindfulness-CBT condition (n=80) or to a waitlist control (WLC) condition (n=80). The 8-week intervention consisted of a web-based platform comprising (1) 12 video-based modules with psychoeducation on students' preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via an online survey at baseline and at 8 weeks postintervention using the Patient Health Questionnaire-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counseling).
RESULTS


Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n=79) and WLC (n=80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At postintervention follow-up, according to the adjusted comparisons, there were statistically significant between-group reductions in depression scores (β=-2.21, P=.01) and anxiety scores (β=-4.82, P=.006), and a significant increase in mindfulness scores (β=4.84, P=.02) compared with the WLC group. There were no statistically significant differences in perceived stress for MVC (β=.64, P=.48) compared with WLC.
CONCLUSIONS


With the MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among postsecondary populations on a large scale, simultaneously reducing the current burden on traditional counseling services.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN12249616; http://www.isrctn.com/ISRCTN12249616.",2020,"There were no statistically significant differences in perceived stress for MVC (β = .64, P = .48) compared to WLC.
","['32 were males and 125 were females with a mean age of 22.55 years', 'undergraduate students at a large Canadian university', 'undergraduate students (n = 160', '159 students who provided T1 data', 'Participants in the MVC (n = 79) and WLC (n = 80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work', 'University Students on Symptoms of Stress, Anxiety, and Depression', 'university students']","['web-based guided mindfulness-CBT condition (n = 80) or to a waitlist control condition (WLC', 'Eight-Week Web-Based Mindfulness Virtual Community Intervention', 'mindfulness meditation and cognitive behavioural therapy [CBT', 'Mindfulness Virtual Community (MVC), a web-based program informed by cognitive behavioral therapy (CBT) constructs and featuring online videos, discussion forums, and videoconferencing', 'eight-week web-based mindfulness and cognitive behavioural therapy (CBT) program', 'Online mindfulness interventions', ""web-based platform consisting of (1) 12 video-based modules with psycho-education on students' preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences""]","['mindfulness scores', 'outcomes (depression, anxiety, stress, and mindfulness', 'depression scores', 'Patient Health Questionniare-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF', 'depression and anxiety symptoms', 'anxiety scores', 'symptoms of depression, anxiety, and stress (primary outcomes', 'perceived stress for MVC']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",160.0,0.0566538,"There were no statistically significant differences in perceived stress for MVC (β = .64, P = .48) compared to WLC.
","[{'ForeName': 'Christo', 'Initials': 'C', 'LastName': 'El Morr', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Moineddin', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, ON, Canada.'}]",JMIR mental health,['10.2196/18595']
1200,32555927,Short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure.,"The objective was to investigate and evaluate the short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure. Forty-nine patients with chronic systolic heart failure during acute decompensation were randomly divided into a levosimendan group (26 cases) and a control group (23 cases). The control group received only routine treatment, while the levosimendan group received a levosimendan bolus with a load of 12 µg/kg, in addition to the same routine treatment as the control group. After 48 hours of treatment, N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in the levosimendan group were significantly lower than those in the control group. In addition, the left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores of the levosimendan group were significantly higher and more improved than those of the control group seven days after treatment, but there was no significant difference in the left ventricular end-diastolic diameter between the two groups. Furthermore, 48 hours after treatment, there were no significant differences in potassium, haemoglobin, haematocrit and creatinine levels between the levosimendan and control groups. During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group. Levosimendan significantly improved NT-proBNP and LVEF in patients with chronic systolic heart failure, and improved NYHA cardiac function classification without significant cardiovascular events. Levosimendan is therefore effective and safe in the short-term treatment of chronic systolic heart failure.",2020,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","['Forty-nine patients with chronic systolic heart failure during acute decompensation', 'patients with chronic systolic heart failure']","['Levosimendan', 'levosimendan', 'levosimendan bolus']","['sudden death', 'hypotension or severe hypokalaemia', 'left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores', 'potassium, haemoglobin, haematocrit and creatinine levels', 'NT-proBNP and LVEF', 'left ventricular end-diastolic diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",49.0,0.0197414,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","[{'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Rui-Bin', 'Initials': 'RB', 'LastName': 'Li', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jia', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. Email: zhangjidong78@163.com.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2020-008']
1201,32562682,"Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial.","BACKGROUND


In A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up.
METHODS


ARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion. Patients were randomly assigned (1:1) by a web-based data collection system, stratified by clinical centre in a random permuted block design with block sizes of two, four, and six, to medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number). Although patients and investigators at a given centre were not masked to treatment assignment, investigators at other centres and those in the clinical coordinating centre were not informed of assignment or outcomes at any of the centres. The primary outcome was time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care, and monitored by an independent committee using an adaptive approach with interim analyses. Enrolment began on April 4, 2007, and was halted on April 15, 2013, after which follow-up continued until July 15, 2015. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00389181.
FINDINGS


Of 1740 patients screened, 226 were randomly assigned to medical management alone (n=110) or medical management plus interventional therapy (n=116). During a mean follow-up of 50·4 months (SD 22·9), the incidence of death or symptomatic stroke was lower with medical management alone (15 of 110, 3·39 per 100 patient-years) than with medical management with interventional therapy (41 of 116, 12·32 per 100 patient-years; hazard ratio 0·31, 95% CI 0·17 to 0·56). Two patients in the medical management group and four in the interventional therapy group (two attributed to intervention) died during follow-up. Adverse events were observed less often in patients allocated to medical management compared with interventional therapy (283 vs 369; 58·97 vs 78·73 per 100 patient-years; risk difference -19·76, 95% CI -30·33 to -9·19).
INTERPRETATION


After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation. The data concerning the disparity in outcomes should affect standard specialist practice and the information presented to patients. The even longer-term risks and differences between the two therapeutic approaches remains uncertain.
FUNDING


National Institute of Neurological Disorders and Stroke for the randomisation phase and Vital Projects Fund for the follow-up phase.",2020,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","['patients with an unruptured brain arteriovenous malformation', '1740 patients screened, 226 were randomly assigned to', '39 clinical centres in nine countries', 'Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion', 'unruptured brain arteriovenous malformations (ARUBA']","['interventional therapy versus medical management alone', 'medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number', 'medical management alone (n=110) or medical management plus interventional therapy']","['death or symptomatic stroke', 'Adverse events', ""time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care"", 'symptomatic stroke or death', 'incidence of death or symptomatic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0003857', 'cui_str': 'Congenital arteriovenous malformation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C3846112', 'cui_str': 'Stereotactic radiosurgery'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",226.0,0.149025,"After extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation.","[{'ForeName': 'Jay P', 'Initials': 'JP', 'LastName': 'Mohr', 'Affiliation': 'Doris and Stanley Tananbaum Stroke Center, The Neurological Institute, Columbia University Irving Medical Center, New York, NY, USA. Electronic address: jpm10@cumc.columbia.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Department of Neurology, Klinikum Frankfurt/Oder, Frankfurt/Oder, Germany.'}, {'ForeName': 'Rüdiger von', 'Initials': 'RV', 'LastName': 'Kummer', 'Affiliation': 'Department of Neuroradiology, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesia and Perioperative Care, Center for Cerebrovascular Research, University of California, San Francisco, CA, USA.'}, {'ForeName': 'H Bart', 'Initials': 'HB', 'LastName': 'van der Worp', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Albert Einstein Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology and Neurosurgery, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Neuroradiology, APHP-Hôpital Lariboisière, Université Paris Diderot-Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Libman', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pile-Spellman', 'Affiliation': 'Department of Neuroradiology, NYU-Winthrop Medical Center, Mineola, NY, USA.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Harkness', 'Affiliation': 'Department of Neurology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cordonnier', 'Affiliation': 'Université Lille, Inserm, CHU Lille, U1172, LilNCog, Lille Neuroscience and Cognition, Lille, France.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Moquete', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Department of Interventional Neuroradiology, Jean Minjoz Hospital, University of Franche Comté, Besançon, France.'}, {'ForeName': 'Catharina J M', 'Initials': 'CJM', 'LastName': 'Klijn', 'Affiliation': 'Department of Neurology and Neurosurgery, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stapf', 'Affiliation': ""Neuroscience Axis, Neurovascular Group, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Division of Neurology, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada; Department of Neurosciences, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30181-2']
1202,32562683,Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.,"BACKGROUND


Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial.
METHODS


REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 . Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.
FINDINGS


Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1-5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85-1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
INTERPRETATION


Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated.
FUNDING


Eli Lilly and Company.",2020,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
","['371 sites in 24 countries', '8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned', 'men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m 2 ', 'Between Aug 18, 2011, and Aug 14, 2013, 9901 participants', 'type 2 diabetes', 'people with type 2 diabetes']","['placebo', 'dulaglutide (1·5 mg) or an equal volume of matching placebo', 'dulaglutide', 'glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide']","['hazard of substantive cognitive impairment', 'stroke, myocardial infarction, or death from cardiovascular or unknown causes', 'cognitive outcome', 'Cognitive function', 'cognitive impairment', 'Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",9901.0,0.689964,"After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).
","[{'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cukierman-Yaffe', 'Affiliation': 'Endocrinology Institute, Gertner Institute, Sheba Medical Center, Ramat-Gan, Israel; Epidemiology Department, Sackler School of Medicine, Herceg Institute of Aging, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Luis-Emilio', 'Initials': 'LE', 'LastName': 'García-Pérez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Angelyn', 'Initials': 'A', 'LastName': 'Bethel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, India.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health and Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital, Warsaw, Poland.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Center, Sofia, Bulgaria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30173-3']
1203,32562684,"Safety and immunogenicity of the α-synuclein active immunotherapeutic PD01A in patients with Parkinson's disease: a randomised, single-blinded, phase 1 trial.","BACKGROUND


Robust evidence supports the role of α-synuclein pathology as a driver of neuronal dysfunction in Parkinson's disease. PD01A is a specific active immunotherapy with a short peptide formulation targeted against oligomeric α-synuclein. This phase 1 study assessed the safety and tolerability of the PD01A immunotherapeutic in patients with Parkinson's disease.
METHODS


We did a first-in-human, randomised, phase 1 study of immunisations with PD01A, followed by three consecutive study extensions. Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria. Patients were randomly assigned (1:1), using a computer-generated sequence with varying block size, to receive four subcutaneous immunisations with either 15 μg or 75 μg PD01A injected into the upper arms and followed up initially for 52 weeks, followed by a further 39 weeks' follow-up. Patients were then randomly assigned (1:1) again to receive the first booster immunisation at 15 μg or 75 μg and were followed up for 24 weeks. All patients received a second booster immunisation of 75 μg and were followed up for an additional 52 weeks. Patients were masked to dose allocation. Primary (safety) analyses included all treated patients. These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16.
FINDINGS


32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible and randomly assigned to receive four PD01A priming immunisations. One patient had a diagnosis change to multiple system atrophy and was withdrawn and two patients withdrew consent during the studies. 21 (87%) of 24 patients received all six immunisations and completed 221-259 weeks in-study (two patients in the 15 μg dose group and one patient in the 75 μg dose group discontinued). All patients experienced at least one adverse event, but most of them were considered unrelated to study treatment (except for transient local injection site reactions, which affected all but one patient). Serial MRI assessments also ruled out inflammatory processes. Systemic treatment-related adverse events were fatigue (n=4), headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2). The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group. Antibody titres returned to baseline over 2 years, but could be rapidly reactivated after booster immunisation from week 116 onwards, reaching geometric group mean titres up to 1:20218.
INTERPRETATION


Repeated administrations of PD01A were safe and well tolerated over an extended period. Specific active immunotherapy resulted in a substantial humoral immune response with target engagement. Phase 2 studies are needed to further assess the safety and efficacy of PD01A for the treatment of Parkinson's disease.
FUNDING


AFFiRiS, Michael J Fox Foundation.",2020,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[""patients with Parkinson's disease"", ""Patients aged 45-65 years with a clinical diagnosis of Parkinson's disease (≤4 years since diagnosis and Hoehn and Yahr Stage 1 to 2), imaging results (dopamine transporter single photon emission CT and MRI) consistent with their Parkinson's disease diagnosis, and on stable doses of Parkinson's disease medications for at least 3 months were recruited at a single private clinic in Vienna, Austria"", 'These four studies were registered with EU Clinical Trials Register, EudraCT numbers 2011-002650-31, 2013-001774-20, 2014-002489-54, and 2015-004854-16', '32 patients were recruited between Feb 14, 2012, and Feb 6, 2013, and 24 were deemed eligible']","['PD01A', 'PD01A immunotherapeutic', 'α-synuclein active immunotherapeutic PD01A']","['Safety and immunogenicity', 'geometric group mean titre of antibodies against the immunising peptide PD01', 'safety and tolerability', 'headache (n=3), myalgia (n=3), muscle rigidity (n=2), and tremor (n=2', 'Antibody titres', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Transporter'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0165073', 'cui_str': 'Synuclein'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]",32.0,0.129353,"The geometric group mean titre of antibodies against the immunising peptide PD01 increased from 1:46 at baseline to 1:3580 at week 12 in the 15 μg dose group, and from 1:76 to 1:2462 at week 12 in the 75 μg dose group.","[{'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Volc', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kutzelnigg', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lührs', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Thun-Hohenstein', 'Affiliation': 'Confraternitaet-Privatklinik Josefstadt, Vienna, Austria.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Schneeberger', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Galabova', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Majbour', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Vaikath', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El-Agnaf', 'Affiliation': 'Neurological Disorders Research Center, Qatar Biomedical Research Institute, Hamad Bin Khalifa University, Qatar Foundation, Doha, Qatar.'}, {'ForeName': 'Dorian', 'Initials': 'D', 'LastName': 'Winter', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mihailovska', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mairhofer', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwenke', 'Affiliation': 'Schwenke Consulting: Strategies and Solutions in Statistics, Berlin, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Staffler', 'Affiliation': 'AFFiRiS, Vienna, Austria. Electronic address: guenther.staffler@affiris.com.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Medori', 'Affiliation': 'AFFiRiS, Vienna, Austria.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30136-8']
1204,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder. This article is part of the special issue on Stress, Addiction and Plasticity.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177']
1205,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND


Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes.
OBJECTIVES


We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL).
METHODS


46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS.
RESULTS


There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion.
CONCLUSIONS


Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015']
1206,32512262,Intensive therapy alleviates subclinical synovitis on ultrasound and disease activity and reduces flare in rheumatoid arthritis patients who have achieved clinical target - a randomized controlled trial.,"OBJECTIVE


Whether intensive therapy can alleviate subclinical synovitis and reduce flare in rheumatoid arthritis (RA) patients in clinical remission remains unclear. We designed a 1-year open-labelled, randomized controlled clinical trial to elucidate this question.
METHODS


RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2] were randomized to receive maintenance or intensive treatment at a ratio of 1:1. The primary outcome was the rate of RA relapse (defined by DAS28-CRP>3.2 and an increase≥0.6). The secondary outcomes were changes of PD and GS scores, and clinical disease activity at each visit from baseline.
RESULTS


108 patients with 54 in each group were enrolled. During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively]. Although GS and PD scores were decreased at 12 months in both groups, the decline was more remarkable in intensive group than in maintenance group. The improvement of clinical disease activity score was only observed in intensive group, not maintenance group. Adverse events were comparable between two groups. Abnormal liver function tests were observed in 24 (22%) patients with 16 from intensive group.
CONCLUSION


Intensive therapy can alleviate subclinical synovitis on ultrasound and clinical disease activity, and prevent relapse in RA patients who have achieved clinical remission or low disease activity, with comparable safety profiles to maintenance therapy.
REGISTRATION NUMBER


ChiCTR2000029279.",2020,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","['rheumatoid arthritis patients who have achieved clinical target ', '24 (22%) patients with 16 from intensive group', 'RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2', '108 patients with 54 in each group were enrolled', 'rheumatoid arthritis']","['Intensive therapy', 'intensive therapy']","['rate of RA relapse', 'Adverse events', 'changes of PD and GS scores, and clinical disease activity', 'GS and PD scores', 'relapse rate', 'clinical disease activity score', 'Abnormal liver function tests']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}]",108.0,0.101084,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China. Electronic address: zhuoli.zhang@126.com.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.014']
1207,32516227,Methadone for postoperative analgesia: contribution of N-methyl-D-aspartate receptor antagonism: A randomised controlled trial.,"BACKGROUND


Over the past number of years, N-methyl-D-aspartate (NMDA) inhibitory drugs, like ketamine, have been introduced as adjuvant treatments for postoperative acute pain, within a multimodal approach. A further extension of this strategy could be the use of opioids with NMDA receptor (NMDAr) antagonism activity for control of postoperative pain. Methadone has a unique pharmacodynamic profile: it is both a μ-agonist and an NMDAr-blocker.
OBJECTIVE


We designed this study to investigate the precise contribution of NMDAr antagonism in methadone-induced analgesia.
DESIGN


Single-centre, prospective, randomised, double-blind study.
SETTING


National Cancer Center - Fondazione IRCCS Istituto Nazionale Tumori Milano; patients were recruited between March 2010 and June 2012.
PATIENTS


Ninety-six patients scheduled for an open laparotomy for anterior resection of the rectum.
INTERVENTIONS


We randomly assigned patients to four groups: 0-Mo (placebo and morphine), K-Mo [S(+)-ketamine and morphine], 0-Me (placebo and methadone), K-Me [S(+)-ketamine and methadone].
MAIN OUTCOME MEASURES


The primary end-point was the extent of mechanical static (punctuate) hyperalgesia to von Frey hair stimulation lateral to the surgical incision.
RESULTS


Peri-incisional hyperalgesia was 8.4 cm (95% confidence interval, 1.5 to 15.41) lower in the treatment group (K-Me) compared with the control group (0-Mo) at 24 h after surgery (P = 0.02). No significant differences were observed between the groups at 48 h after surgery (P = 0.88). Both groups treated with methadone had significantly lower pain during rest and movement, as measured with a Numerical Rating Scale at 24 h. At 48 h, only the movement Numerical Rating Scale was significantly lower. No difference occurred in opioid consumption.
CONCLUSION


Methadone provides effective control of acute postoperative pain, independently, by modulation of the hyperalgesia mechanism.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, no.: NCT01594047.",2020,"Both groups treated with methadone had significantly lower pain during rest and movement, as measured with a Numerical Rating Scale at 24 h.","['Ninety-six patients scheduled for an open laparotomy for anterior resection of the rectum', 'National Cancer Center - Fondazione IRCCS Istituto Nazionale Tumori Milano; patients were recruited between March 2010 and June 2012']","['placebo and morphine), K-Mo', 'N-methyl-D-aspartate receptor antagonism', '0-Mo', 'placebo and methadone), K-Me', 'S(+)-ketamine and morphine', 'methadone', 'Methadone', 'S(+)-ketamine and methadone']","['movement Numerical Rating Scale', 'mechanical static (punctuate) hyperalgesia to von Frey hair stimulation lateral to the surgical incision', 'Numerical Rating Scale', 'opioid consumption', 'pain', 'Peri-incisional hyperalgesia']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",96.0,0.486354,"Both groups treated with methadone had significantly lower pain during rest and movement, as measured with a Numerical Rating Scale at 24 h.","[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tognoli', 'Affiliation': 'From the Department of Anesthesiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy (ET, PLP, FV), the Department of Anesthesiology ASST Vimercate Monza-Brianza, Italy (GM), the Department of Clinical Science and Comunity, University of Milan, Milano, Italy (CG), the Unit of Clinical epidemiology and Trial organization, Fondazione IRCCS Istituto nazionale dei Tumori, Milano, Italy (LM), and the Department of Oncology and Onco-Hematology, University Of Milan, Milano, Italy (FV).'}, {'ForeName': 'Paolo L', 'Initials': 'PL', 'LastName': 'Proto', 'Affiliation': ''}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Motta', 'Affiliation': ''}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Galeone', 'Affiliation': ''}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': ''}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Valenza', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001217']
1208,32516270,"Crossover associations of alcohol and smoking, craving and biochemically verified alcohol and nicotine use in heavy drinking smokers.","This study examined associations between drinking and smoking prior to treatment (biochemically measured at baseline), alcohol and tobacco craving, and biochemical alcohol and tobacco use during the analog trial period. We conducted a secondary data analysis of a randomized clinical analog trial where participants with a Diagnostic and Statistical Manual, Fourth Edition Text Revision (DSM-IV-TR) diagnosis of alcohol dependence, abuse or reported heavy drinking, with a co-occurring DSM-IV-TR diagnosis of nicotine dependence, abuse or reported heavy use, who were not seeking treatment were recruited. A generalized estimation equation model for longitudinal binary outcomes was created (N = 34) to determine the predictive effects of baseline tobacco use, alcohol craving, and tobacco craving on alcohol use over the 4 weeks of the trial. Baseline smoking was significantly (*p < 0.05) associated with drinking over time [odds ratio (OR) = 3.09*], while baseline drinking was associated with smoking (OR = 4.17*). Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92*, respectively) but were negatively associated with alcohol use over time (OR = 0.79* and OR = 0.57*, respectively). Heavier use of either tobacco or alcohol preceding treatment may require more intensive interventions in order to reduce tobacco and alcohol use. Future trials designed to address mechanisms of behavior change in the context of novel treatments could promote a better understanding of the cross-rewarding effects related to the co-use of these substances and lead to the development of more integrated and appropriately intense treatments for individuals with concomitant tobacco and alcohol use disorders.",2020,Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92,"['individuals with concomitant tobacco and alcohol use disorders', 'heavy drinking smokers', 'participants with a Diagnostic and Statistical Manual, Fourth Edition Text Revision (DSM-IV-TR) diagnosis of alcohol dependence, abuse or reported heavy drinking, with a co-occurring DSM-IV-TR diagnosis of nicotine dependence, abuse or reported heavy use, who were not seeking treatment were recruited']",['tobacco or alcohol'],"['Baseline alcohol and tobacco craving', 'alcohol and tobacco craving, and biochemical alcohol and tobacco use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]",,0.0128751,Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92,"[{'ForeName': 'Crystal Lederhos', 'Initials': 'CL', 'LastName': 'Smith', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Jenkins', 'Affiliation': 'Prevention Science.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Burduli', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Tham', 'Affiliation': 'Elson S. Floyd College of Medicine.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Miguel', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': 'Program of Excellence in Addictions Research.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'Mcpherson', 'Affiliation': 'Program of Excellence in Addictions Research.'}]",Behavioural pharmacology,['10.1097/FBP.0000000000000568']
1209,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION


PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers.
METHODS


A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study.
RESULTS


Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups.
CONCLUSIONS


Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02629289; NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x']
1210,32524500,"Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis.","INTRODUCTION


The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
METHODS


Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
RESULTS


Of 1718 total enrolled patients, 196 Asian patients (denosumab, n = 103; zoledronic acid, n = 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
CONCLUSION


Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01345019.",2020,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","['Newly Diagnosed Multiple Myeloma', 'adults with newly diagnosed multiple myeloma (MM', 'Asian patients', 'Patients', 'Asian patients with newly diagnosed MM with lytic bone lesions', '1718 total enrolled patients, 196 Asian patients (denosumab, n\u2009=\u2009103; zoledronic acid, n\u2009=\u200993', 'All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE']","['standard-of-care first-line antimyeloma treatment', 'zoledronic acid', 'Denosumab Versus Zoledronic Acid', 'denosumab versus zoledronic acid', 'denosumab 120\xa0mg subcutaneously or zoledronic acid']","['diarrhea', 'skeletal-related events (SREs', 'treatment-emergent hypocalcemia', 'renal toxicity', 'pyrexia', 'efficacy and safety', 'Efficacy and safety outcomes', 'crude incidence of SREs', 'nausea']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",196.0,0.620923,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","[{'ForeName': 'Shang-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Wee Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore, National University Health System, Singapore, Republic of Singapore.'}, {'ForeName': 'Cheng-Shyong', 'Initials': 'CS', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Raymond Siu-Ming', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Sir Y.K. Pao Centre for Cancer and Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Seasea', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Gordon', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Glennane', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Department of Hematology, Seoul St. Mary's Hospital, Seoul, Republic of Korea. ckmin@catholic.ac.kr.""}]",Advances in therapy,['10.1007/s12325-020-01395-x']
1211,32526210,"Clinical effectiveness of pharmacist-led versus conventionally delivered antiviral treatment for hepatitis C virus in patients receiving opioid substitution therapy: a pragmatic, cluster-randomised trial.","BACKGROUND


Highly effective direct-acting antiviral drugs provide the opportunity to eliminate hepatitis C virus (HCV) infection, but established pathways can be ineffective. We aimed to examine whether a community pharmacy care pathway increased treatment uptake, treatment completion, and cure rates for people receiving opioid substitution therapy, compared with conventional care.
METHODS


This cluster-randomised trial was done in Scottish community pharmacies. Before participants were recruited, pharmacies were randomly assigned (1:1) to refer patients with evidence of HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care). Pharmacies were stratified by location. All pharmacies were trained to offer dried blood spot testing. All eligible participants had received opioid substitution therapy for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration. Neither pharmacists nor patients were masked to treatment allocation. In both groups, assessment blood samples were taken, infection with HCV was confirmed, and daily oral ledipasvir-sofosbuvir (90 mg ledipasivir plus 400 mg sofosbuvir) for 8 weeks for genotype 1 or daily oral sofosbuvir (400 mg) plus oral daclatasvir (60 mg) for 12 weeks for genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group). In the conventional care group, the patient received care at a treatment centre. Once prescribed, medication in both groups was delivered as daily modified directly observed therapy alongside opioid substitution therapy in the participants' pharmacy where treatment was observed on 6 days per week. The primary outcome was the number of patients with sustained virological response 12 weeks after completion of treatment (SVR12) as a proportion of the number of people receiving opioid substitution therapy at participating pharmacies. Participants were monitored at each visit for nausea and fatigue; other adverse events were recorded as free text. Secondary outcomes compared key points on treatment pathway between the two groups. These key points were the proportion of patients having dry blood spot testing, the proportion of patients initiating HCV treatment, the proportion of patients completing the 8 or 12 week HCV course of treatment, and the proportion of patients with sustained virological response at 12 months. This study is registered with ClinicalTrials.gov, NCT02706223.
FINDINGS


56 pharmacies were randomly assigned (28 to each group; one pharmacy withdrew from the conventional care group). The 55 participating pharmacies included 2718 patients receiving opioid substitution therapy (1365 in the pharmacist-led care group and 1353 in the conventional care group). More patients met the primary endpoint of SVR12 in the pharmacist-led care group (98 [7%] of 1365) than in the conventional care group (43 [3%] of 1353; odds ratio 2·375, 95% CI 1·555-3·628, p<0·0001). More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007). The data for sustained virological response at 12 months are not reported in this study: patients remain in follow-up for this outcome. No serious adverse events were recorded.
INTERPRETATION


Using pharmacists to deliver an HCV care pathway made testing and treatment more accessible for patients, improved engagement, and maintained high treatment success rates. The use of this pathway could be a key part of an integrated and effective approach to HCV elimination at a community level.
FUNDING


Partnership between the Scottish Government, Gilead Sciences, and Bristol-Myers Squib.",2020,"More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007).","['1365 in the pharmacist-led care group and 1353 in the conventional care group', '56 pharmacies', 'patients receiving opioid substitution therapy', 'Scottish community pharmacies', '55 participating pharmacies included 2718 patients receiving', 'people receiving opioid substitution therapy, compared with conventional care', 'for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration']","['opioid substitution therapy', 'oral daclatasvir', 'genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group', 'HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care', 'daily modified directly observed therapy alongside opioid substitution therapy', 'pharmacist-led versus conventionally delivered antiviral treatment']","['sustained virological response', 'nausea and fatigue; other adverse events', 'serious adverse events', 'SVR12', 'number of patients with sustained virological response']","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C3888499', 'cui_str': 'Polymerase chain reaction positive'}, {'cui': 'C3532919', 'cui_str': 'Hepatitis C virus genotype 1'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",2718.0,0.107076,"More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'NHS Tayside, Directorate of Public Health, Kings Cross Hospital, Dundee, UK; University of Dundee, Ninewells Hospital and Medical School, Dundee, UK. Electronic address: andrew.radley@nhs.net.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'de Bruin', 'Affiliation': 'Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands; University of Aberdeen, Institute of Applied Health Sciences, Aberdeen, UK.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Inglis', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hapca', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Barclay', 'Affiliation': 'NHS Greater Glasgow and Clyde, Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK; Glasgow Caledonian University, Department of Life Sciences, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fraser', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Foresterhill Health Campus, Aberdeen, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dillon', 'Affiliation': 'University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30120-5']
1212,32531393,"Erratum to: Britton B, Baker AL, Wolfenden L, Wratten C, Bauer J, Beck AK, McCarter K, Harrowfield J, Isenring E, Tang C, Oldmeadow C, and Carter G. Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). Int J Radiat Oncol Biol Phys 2019.",,2020,,['Patients With Head and Neck Cancer Undergoing Radiation Therapy'],['Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",[],,0.0400018,,[],"International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.010']
1213,32540842,One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial.,"BACKGROUND


In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop's digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A 1c  level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A 1c  level of 22.2 mg/dL (-0.80%). However, the added value of integrated activity trackers is unknown.
OBJECTIVE


We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A 1c  level of adults with type 1 diabetes.
METHODS


Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop's full solution and the activity tracker, with a laboratory hemoglobin A 1c  level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A 1c , were used to evaluate 3-month hemoglobin A 1c  differences in intent-to-treat (ITT) and per protocol (PP) analyses.
RESULTS


The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A 1c  level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A 1c  level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A 1c  level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4).
CONCLUSIONS


Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A 1c  level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.",2020,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","['Participants (N = 99', ""adults with T1D.\nMETHODS\n\n\nSocial media advertisements and online newsletters recruited adults (≥ 18 years old) diagnosed (≥ 1 year) with T1D, naïve to OD's full solution and the activity tracker with lab A1c ≥ 7"", 'The enrolled sample (n = 95) was 41 ± 11 years old, 73% female, 88% White, diagnosed for 20 ± 11 years with a mean A1c of 8.4% ± 1.2', 'Adults with Type 1 Diabetes']","['OD plus activity tracker', 'new-to-market activity tracker', 'Activity Tracker']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}]",[],99.0,0.0789327,"In ITT, participants with OD + tracker had a significantly lower three-month A1c (7.9% [95% CI 7.8 - 8.2]  .60%) than did participants with OD only (8.4% [95% CI 8.2 - 8.5]  .62%).","[{'ForeName': 'Chandra Y', 'Initials': 'CY', 'LastName': 'Osborn', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Sears', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heyman', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'Division of Endocrinology, Department of Pediatrics, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Huddleston', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Dachis', 'Affiliation': 'Informed Data Systems Inc, New York, NY, United States.'}]",JMIR mHealth and uHealth,['10.2196/16745']
1214,32542474,A Resilience Intervention for Adults with Type 2 Diabetes: Proof-of-Concept in Community Health Centers.,"BACKGROUND


Given the psychological stress associated with managing type 2 diabetes (T2D), resilience-promoting interventions may particularly benefit populations experiencing high levels of stress (e.g., racial/ethnic minority and lower-income individuals). Federally qualified Community Health Centers (CHCs) primarily serve these patients and are therefore ideal settings for resilience-promoting T2D programs. This proof-of-concept study tested the Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention within a CHC.
METHOD


Thirty-five patients with T2D (M age = 51 years, 71% female, 60% Hispanic, 69% annual household income < $20,000) at two clinics within the CHC completed the RB-DSME, consisting of eight bi-weekly classes and two monthly support groups. In this treatment-only design, resilience resources, self-management behaviors, and physical and mental health outcomes were measured at baseline and 6 months.
RESULTS


Attendance (M = 7.66/10) and program satisfaction (M = 6.79/7) were high. Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85). Large increases in self-management behaviors (d = 1.38) and number of steps (d = 1.11) were also observed. Participants lowered A1C from baseline (M = 8.79%) to 6 months (M = 8.11%; d = .50), along with diabetes distress (d = 1.31), depressive symptoms (d = .80), and general perceived stress (d = .55).
CONCLUSION


This study demonstrated the ability of the RB-DSME to improve resilience resources, self-management behaviors, and health outcomes among racial/ethnic minority and lower-income patients with T2D at clinics within a CHC. A larger, randomized trial should more rigorously test the RB-DSME in this clinical setting.",2020,"Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85).","['Adults with Type 2 Diabetes', 'racial/ethnic minority and lower-income patients with T2D at clinics within a CHC', 'Thirty-five patients with T2D (M age\u2009=\u200951\xa0years, 71% female, 60% Hispanic, 69% annual household income <\u2009$20,000) at two clinics within the CHC completed the RB-DSME, consisting of eight bi-weekly classes and two monthly support groups']","['RB-DSME', 'Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention']","['adaption to stress', 'adaptive coping', 'resilience resources, self-management behaviors, and physical and mental health outcomes', 'diabetes distress', 'diabetes empowerment', 'self-management behaviors', 'depressive symptoms', 'program satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",35.0,0.0303655,"Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85).","[{'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Dubois', 'Affiliation': 'Department of Internal Medicine, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'H Matthew', 'Initials': 'HM', 'LastName': 'Lehrer', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Erum Z', 'Initials': 'EZ', 'LastName': 'Whyne', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Steinhardt', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA. msteinhardt@austin.utexas.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09894-5']
1215,32537643,Effects of a modestly lower carbohydrate diet in gestational diabetes: a randomized controlled trial.,"BACKGROUND


Lower carbohydrate diets have the potential to improve glycemia but may increase ketonemia in women with gestational diabetes (GDM). We hypothesized that modestly lower carbohydrate intake would not increase ketonemia.
OBJECTIVE


To compare blood ketone concentration, risk of ketonemia, and pregnancy outcomes in women with GDM randomly assigned to a lower carbohydrate diet or routine care.
METHODS


Forty-six women aged (mean ± SEM) 33.3 ± 0.6 y and prepregnancy BMI 26.8 ± 0.9 kg/m2 were randomly assigned at 28.5 ± 0.4 wk to a modestly lower carbohydrate diet (MLC, ∼135 g/d carbohydrate) or routine care (RC, ∼200 g/d) for 6 wk. Blood ketones were ascertained by finger prick test strips and 3-d food diaries were collected at baseline and end of the intervention.
RESULTS


There were no detectable differences in blood ketones between completers in the MLC group compared with the RC group (0.1 ± 0.0 compared with 0.1 ± 0.0 mmol/L, n = 33, P = 0.31, respectively), even though carbohydrate and total energy intake were significantly lower in the intervention group (carbohydrate 165 ± 7 compared with 190 ± 9 g, P = 0.04; energy 7040 ± 240 compared with 8230 ± 320 kJ, P <0.01, respectively). Only 20% of participants in the MLC group met the target intake compared with 65% in the RC group (P <0.01). There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
CONCLUSIONS


An intervention to reduce carbohydrate intake in GDM did not raise ketones to clinical significance, possibly because the target of 135 g/d was difficult to achieve in pregnancy. Feeding studies with food provision may be needed to assess the benefits and risks of low-carbohydrate diets. This trial was registered at www.anzctr.org.au as ACTRN12616000018415.",2020,"There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
","['Forty-six women aged (mean\xa0±\xa0SEM) 33.3\xa0±\xa00.6 y and prepregnancy', 'gestational diabetes', 'women with gestational diabetes (GDM', 'women with GDM randomly assigned to a']","['MLC', 'lower carbohydrate diet or routine care', 'modestly lower carbohydrate diet']","['Blood ketones', 'blood ketones', 'blood ketone concentration, risk of ketonemia, and pregnancy outcomes', 'carbohydrate and total energy intake', 'target intake', 'birth weight, rate of large']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0427750', 'cui_str': 'Ketone concentration, test strip measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0235430', 'cui_str': 'Ketonemia'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",46.0,0.19441,"There were no differences in birth weight, rate of large-for-gestational-age infants, percent fat mass, or fat-free mass between groups.
","[{'ForeName': 'Jovana', 'Initials': 'J', 'LastName': 'Mijatovic', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jimmy Chun Yu', 'Initials': 'JCY', 'LastName': 'Louie', 'Affiliation': 'School of Biological Sciences, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Marion E C', 'Initials': 'MEC', 'LastName': 'Buso', 'Affiliation': 'Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.'}, {'ForeName': 'Fiona S', 'Initials': 'FS', 'LastName': 'Atkinson', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Glynis P', 'Initials': 'GP', 'LastName': 'Ross', 'Affiliation': 'Boden Collaboration Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'Boden Collaboration Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jennie C', 'Initials': 'JC', 'LastName': 'Brand-Miller', 'Affiliation': 'School of Life and Environmental Sciences, The University of Sydney, Sydney, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa137']
1216,32536496,External Cardiac Massage Training of Medical Students: A Randomized Comparison of Two Feedback Methods to Standard Training.,"BACKGROUND


The most recent recommendations support learning of external cardiac massage (ECM) through feedback devices.
OBJECTIVES


The objective was to compare the effects on immediate and 3-month retention of ECM technical skills when using feedback devices compared with training without feedback as part of a half-day training session in medical students.
METHODS


This randomized study was performed using the Resusci Anne QCPR manikin in 64 medical students. We compared the quality of ECM with nonfeedback training in the control group (group 1) vs. 2 feedback learning methods (group 2, PocketCPR and group 3, Skill Reporter each used with visual display available to the trainee). At the end of the training session and 3 months later, students performed chest compressions blindly during a 2-min assessment session. The median compression score was the primary outcome for assessing immediate and long-term retention.
RESULTS


Regarding immediate retention, the median compression score was significantly lower in group 1 (23%) than in groups 2 (81%) and 3 (72%) (p < 0.05) with no difference between the 2 feedback methods. At 3 months, mean compression scores remained high but not significantly different between the 2 feedback groups.
CONCLUSION


The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students. At 3 months, the 2 groups with feedback retained a high level of performance. No significant difference could be demonstrated between the 2 feedback methods.",2020,The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students.,"['Medical Students', 'medical students', '64 medical students']","['external cardiac massage (ECM', 'External Cardiac Massage Training', 'ECM with nonfeedback training', 'feedback learning methods (group 2, PocketCPR and group 3, Skill Reporter each used with visual display available to the trainee', 'ECM training']","['mean compression scores', 'median compression score', 'quality of immediate retention of technical ECM skills']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0009039', 'cui_str': 'Manual external cardiac massage with closed chest'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0335038', 'cui_str': 'Reporter'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0009039', 'cui_str': 'Manual external cardiac massage with closed chest'}]",,0.0523229,The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Suet', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Blanie', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'de Montblanc', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Roulleau', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benhamou', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.058']
1217,32546648,Predictive Value of Molecular Subtypes in Premenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the ABCSG Trial 5.,"PURPOSE


To assess the predictive value of molecular breast cancer subtypes in premenopausal patients with hormone receptor-positive early breast cancer who received adjuvant endocrine treatment or chemotherapy.
EXPERIMENTAL DESIGN


Molecular breast cancer subtypes were centrally assessed on whole tumor sections by IHC in patients of the Austrian Breast and Colorectal Cancer Study Group Trial 5 who had received either 5 years of tamoxifen/3 years of goserelin or six cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Luminal A disease was defined as Ki67 <20% and luminal B as Ki67 ≥20%. The luminal B/HER2-positive subtype displayed 3+ HER2-IHC or amplification by ISH. Recurrence-free survival (RFS) and overall survival (OS) were analyzed using Cox models adjusted for clinical and pathologic factors.
RESULTS


185 (38%), 244 (50%), and 59 (12%) of 488 tumors were classified as luminal A, luminal B/HER2-negative and luminal B/HER2-positive, respectively. Luminal B subtypes were associated with poor outcome. Patients with luminal B tumors had a significantly shorter RFS [adjusted HR for recurrence: 2.22; 95% confidence interval (CI), 1.41-3.49;  P  = 0.001] and OS (adjusted HR for death: 3.51; 95% CI, 1.80-6.87;  P  < 0.001). No interaction between molecular subtypes and treatment was observed (test for interaction:  P  = 0.84 for RFS;  P  = 0.69 for OS).
CONCLUSIONS


Determination of molecular subtypes by IHC is an independent prognostic factor for recurrence and death in premenopausal women with early-stage, hormone receptor-positive breast cancer but is not predictive for outcome of adjuvant treatment with tamoxifen/goserelin or CMF.",2020,"Patients with Luminal B tumors had a significantly shorter RFS (adjusted hazard ratio [HR] for recurrence: 2.22, 95% confidence interval [CI] 1.41-3.49, P = 0.001) and OS (adjusted HR for death: 3.51, 95% CI 1.80-6.87, P < 0.001).","['premenopausal hormone receptor-positive early breast cancer patients who received', 'premenopausal women with hormone receptor-positive early breast cancer', 'Trial 5 who had received either 5 years of tamoxifen/3 years of goserelin or six cycles of', 'premenopausal women with early-stage, hormone receptor-positive breast cancer', 'Molecular breast cancer subtypes were centrally assessed on whole tumor sections by immunohistochemistry (IHC) in patients of the Austrian Breast and Colorectal Cancer Study Group (ABCSG']","['tamoxifen/goserelin or CMF', 'adjuvant endocrine treatment or chemotherapy', 'cyclophosphamide, methotrexate, and fluorouracil (CMF']","['Luminal A disease', 'Recurrence-free survival (RFS) and overall survival (OS', 'shorter RFS']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",488.0,0.183225,"Patients with Luminal B tumors had a significantly shorter RFS (adjusted hazard ratio [HR] for recurrence: 2.22, 95% confidence interval [CI] 1.41-3.49, P = 0.001) and OS (adjusted HR for death: 3.51, 95% CI 1.80-6.87, P < 0.001).","[{'ForeName': 'Zsuzsanna', 'Initials': 'Z', 'LastName': 'Bago-Horvath', 'Affiliation': 'Department of Pathology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Margaretha', 'Initials': 'M', 'LastName': 'Rudas', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Singer', 'Affiliation': 'Department of Gynecology, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'III Medical Department, Salzburg Cancer Research Institute, Cancer Cluster Salzburg, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Balic', 'Affiliation': 'Department of Internal Medicine, Division of Oncology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Sigurd F', 'Initials': 'SF', 'LastName': 'Lax', 'Affiliation': 'Department of Pathology, Hospital Graz II, Graz, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Kwasny', 'Affiliation': 'Department of Surgery, Hospital Wiener Neustadt, Wiener Neustadt, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hulla', 'Affiliation': 'Department of Pathology, Hospital Wiener Neustadt, Wiener Neustadt, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Comprehensive Cancer Center, Medical University Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Filipits', 'Affiliation': 'Institute of Cancer Research, Department of Medicine I, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. martin.filipits@meduniwien.ac.at.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0673']
1218,32682996,THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design.,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.",2020,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","['Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress', 'teens with type 1 diabetes', 'adolescents with T1D']","['Diabetes Education + text-message-based Positive Affect intervention', 'Positive psychology intervention']","[""adolescents' diabetes distress, self-management, and glycemic control"", 'diabetes distress']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0417244,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Vanderbilt University Medical Center, USA. Electronic address: sarah.jaser@vumc.org.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Datye', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Morrow', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Sinisterra', 'Affiliation': ""Children's National Hospital, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'LeStourgeon', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Fayo', 'Initials': 'F', 'LastName': 'Abadula', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Streisand', 'Affiliation': ""Children's National Hospital, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106086']
1219,32569700,The effects of combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy on intermediate markers of cardiovascular risk in the CANVAS program.,"BACKGROUND


Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA) reduce cardiovascular events, and improve intermediate markers of cardiometabolic health, in those with type 2 diabetes. We investigated these effects in the CANVAS Program.
METHODS AND RESULTS


The CANVAS Program comprised 2 double-blind, randomized, placebo-controlled trials (CANVAS and CANVAS-R) done in patients with type 2 diabetes and elevated cardiovascular risk. Effects were estimated using mixed-effects models for continuous measures and Cox regression models for other outcomes. Randomized treatment by subgroup interaction terms were used to compare effects of canagliflozin versus placebo across subgroups defined by baseline use of GLP1-RA. There were 10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline. Those using GLP1-RA at baseline were less likely to have a history of cardiovascular disease (60.4% vs 65.8%), had a longer duration of diabetes (15.2 vs 13.5 years) and a higher body mass index (BMI; 35.6 vs 31.8 kg/m 2 ) but were otherwise similar. There were greater reductions with canagliflozin versus placebo for HbA1c (-0.75% versus -0.58%; P = .0091), SBP (-6.26 versus -3.83 mmHg; P = .0018), and body weight (-3.79 versus -2.18 kg; P < .0001) in those on baseline GLP1-RA therapy. Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74).
CONCLUSIONS


There may be a synergistic effect of SGLT2 inhibition when used on a background of GLP1-RA for intermediate cardiometabolic markers.",2020,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74).
","['10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline', 'patients with type 2 diabetes and elevated cardiovascular risk']","['canagliflozin versus placebo', 'placebo-controlled trials (CANVAS and CANVAS-R', 'combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy', 'Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA']","['body weight', 'history of cardiovascular disease', 'total serious adverse events', 'major adverse cardiac events', 'longer duration of diabetes', 'SBP', 'eGFR slope']","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",10142.0,0.359796,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74).
","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia. Electronic address: carnott@georgeinstitute.org.au.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of New South Wales, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia; Kolling Institute, Royal North Shore Hospital and University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.""}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Lam', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; National Heart Centre Singapore and Duke-National University, Singapore.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Baim Institute for Clinical Research, Boston, MA, USA.""}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.011']
1220,32574223,A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults.,"PURPOSE


Nitrate (NO3-), through its conversion to nitrite (NO2-) and nitric oxide, has been shown to increase exercise tolerance in healthy younger adults and older diseased patients. Nitrate's effect in well-trained middle to older-aged adults has not been studied. Therefore, the purpose of this investigation was to examine the effects of a NO3- rich beverage on submaximal constant work rate exercise time in well-trained middle to older-aged adults.
METHODS


This was a randomized controlled cross-over trial with 15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments (NO3- rich beverage then placebo or placebo then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed.
RESULTS


The NO3- rich beverage increased plasma NO3- and NO2- levels by 260 μM and 0.47 μM, respectively (p<0.001). Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (1130±151 vs 1060±132 sec, respectively). Changes in exercise time between the two conditions ranged from a 55% improvement to a 40% decrease with the NO3- rich beverage. Oxygen consumption and rating of perceived exertion were not significantly different between the two conditions.
CONCLUSION


In middle to older-aged well-trained adults, NO3- supplementation has non-significant, albeit highly variable, effects on exercise tolerance. ClinicalTrials.gov Identifier: NCT03371966.",2020,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"['healthy younger adults and older diseased patients', 'well-trained middle to older-aged adults', 'well-trained middle and older-aged adults', ""then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed"", '15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments']","['NO3- rich beverage then placebo or placebo', 'nitrate supplementation', 'NO3- rich beverage']","['exercise time', 'Exercise time', 'exercise tolerance', 'submaximal constant work rate exercise time', 'plasma NO3- and NO2- levels', 'Oxygen consumption and rating of perceived exertion']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.426141,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Macie S', 'Initials': 'MS', 'LastName': 'Fletcher', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Caleb G', 'Initials': 'CG', 'LastName': 'Jones', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Gauthier', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Summer L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Heinrich', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0235047']
1221,32506083,Efficacy of Intra-peritoneal Tramadol Instillation for Postoperative Pain Management after Laparoscopic Cholecystectomy.,"Gall stone disease is one of the most common conditions encountered in general surgical practices in adult population. The gold standard treatment for symptomatic gall stone disease is laparoscopic cholecystectomy. It results in less post-operative pain as compared to open cholecystectomy but post-operative pain may be mild, moderate or even severe in some patients. This Randomized control trail was conducted to In-patient department of Surgery, Mymensingh Medical College & Hospital (MMCH), Mymensingh, Bangladesh from April 2018 to September 2018. It was undertaken to evaluate the analgesic effect of intra-peritoneal tramadol instillation in patients undergoing laparoscopic cholecystectomy. Total 70 patients with symptomatic gallstone disease undergoing laparoscopic cholecystectomy were randomized equally in two groups. Then patients were selected in according to the inclusion and exclusion criteria. In first group (Group A), patients were received intra-peritoneal tramadol 100mg (diluted in 20.0ml distilled water). Sprayed 10.0ml diluted tramadol into the sub diaphragmatic area, 5.0ml into the area of gall bladder bed and 5.0ml into the space between the liver and kidney under direct vision just before removal of trocars. In second group (Group B) the conventional operative procedure was followed. Postoperatively, patient was extubated and shifted to recovery room. Data recorded and analyzed, such as post-operative pain score at 1, 4, 8, and 24 hour; cumulative 1, 8 and 24 hour analgesic consumption. In addition that postoperative hospital period monitoring of heart rate, blood pressure, respiratory rate, temperature at 0, 4, 8, 24 hours was also analyzed. Intensity of pain was assessed by Visual Analogue Scale (VAS) scoring system. Patients showed a VAS ≥3 or patients who requested for analgesia was administrated a supplemental dose of analgesic. In the present study the mean pain scores in Group A were found to be low at1hourpost-operative was 0.60±0.56 and there was a gradual increase in score in respect of time interval with peak of 2.07±0.91 at 24 hours. Whereas, in Group B the mean pain scores immediate post-operative period were at its peak was, 2.50±0.82 which decreased to 1.30±0.84 at 1 hour and further there was rise at 4 hours (2.10±0.71) and 24 hours (2.33±0.0.71). But at any point of time the mean VAS remained significantly low (p<0.050) in patients with Group A compared to Group B except at 1st 24 hours (p=0.210). Intra-peritoneal instillation of tramadol for postoperative pain control in laparoscopic cholecystectomy has beneficial effect in terms of postoperative pain relief following laparoscopic cholecystectomy.",2020,Intra-peritoneal instillation of tramadol for postoperative pain control in laparoscopic cholecystectomy has beneficial effect in terms of postoperative pain relief following laparoscopic cholecystectomy.,"['patient department of Surgery, Mymensingh Medical College & Hospital (MMCH), Mymensingh, Bangladesh from April 2018 to September 2018', 'Postoperative Pain Management after Laparoscopic Cholecystectomy', 'patients undergoing laparoscopic cholecystectomy', 'Total 70 patients with symptomatic gallstone disease undergoing', 'laparoscopic cholecystectomy']","['Sprayed 10.0ml diluted tramadol', 'intra-peritoneal tramadol 100mg (diluted in 20.0ml distilled water', 'laparoscopic cholecystectomy', 'tramadol', 'Intra-peritoneal Tramadol Instillation', 'intra-peritoneal tramadol instillation']","['mean VAS', 'Intensity of pain', 'mean pain scores', 'mean pain scores immediate post-operative period', 'Visual Analogue Scale (VAS) scoring system', 'postoperative pain relief', 'heart rate, blood pressure, respiratory rate, temperature']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",70.0,0.025355,Intra-peritoneal instillation of tramadol for postoperative pain control in laparoscopic cholecystectomy has beneficial effect in terms of postoperative pain relief following laparoscopic cholecystectomy.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Reza', 'Affiliation': 'Dr Ehsanur Reza, Associate Professor, Department of Surgery, Mymensingh Medical College (MMC), Mymensingh, Bangladesh.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bhuiyan', 'Affiliation': ''}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Emon', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Biplob', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kader', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Habib', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hasan', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Chaudary', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rahman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hasan', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Nisa', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1222,32506088,Effect of Intravenous Paracetamol with Bupivacaine Scalp Nerve Block on Haemodynamics Response as Well as Anaesthetic Requirements during Supratentorial Craniotomies.,"Noxious stimuli during craniotomy may encourage hypertension and tachycardia, which may rise to morbidity in patients with intracranial hypertension. After craniotomy a moderate level of postoperative pain observed. The objective of this study was to observe the effect of intravenous paracetamol with bupivacaine scalp nerve block (SNB) on haemodynamics response as well as anaesthetic & analgesic requirements during supratentorial craniotomies. This is a single-blind, placebo-controlled, randomized clinical trial carried out in the Neurosurgery operation theatre from August 2015 to July 2017 under supervision of Department of Anaesthesia, Analgesia and Intensive Care Medicine of Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. A total of 40 patients aged 18-60 years with supratentorial space occupying lesion undergoing craniotomy under general anaesthesia who were attended in the department of Neurosurgery, BSMMU were enrolled in this study and they were divided randomly into two groups, 20 patients in each. The Group A received 100ml normal saline infusion and 0.25% bupivacaine (20ml) in scalp block, while the Group B received intravenous injection paracetamol (1gm) and 0.25% bupivacaine (total 20ml) in scalp block. Statistical analyses were obtained Statistical Packages for Social Sciences (SPSS-22). The mean systolic blood pressure varied within the normal range in both groups. The mean DBP of Group B remained significantly lower than that of Group A in different follow up except at 30 minutes and 60 minutes after dura incision. However, mean MAP of Group B remained significantly lower than that of Group A in different time interval. The mean heart rate of Group B remained significantly lower than that of Group A. The mean intraoperative propofol as well as fentanyl requirements were significantly decreased in Group B in comparison to Group A. The combination of intravenous paracetamol with bupivacaine scalp nerve block provides better intra-operative haemodynamic stability and neurosurgical compliances for the patients undergoing supratentorial craniotomies under general anaesthesia.",2020,The mean DBP of Group B remained significantly lower than that of Group A in different follow up except at 30 minutes and 60 minutes after dura incision.,"['patients undergoing supratentorial craniotomies under general anaesthesia', '40 patients aged 18-60 years with supratentorial space occupying lesion undergoing craniotomy under general anaesthesia who were attended in the department of Neurosurgery, BSMMU were enrolled in this study and they were divided randomly into two groups, 20 patients in each', 'Neurosurgery operation theatre from August 2015 to July 2017 under supervision of Department of Anaesthesia, Analgesia and Intensive Care Medicine of Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'supratentorial craniotomies', 'Supratentorial Craniotomies', 'patients with intracranial hypertension']","['Intravenous Paracetamol', 'bupivacaine scalp nerve block', 'bupivacaine scalp nerve block (SNB', 'paracetamol', 'intravenous injection paracetamol (1gm) and 0.25% bupivacaine (total 20ml) in scalp block', '100ml normal saline infusion and 0.25% bupivacaine (20ml) in scalp block', 'Bupivacaine Scalp Nerve Block', 'placebo']","['mean systolic blood pressure', 'fentanyl requirements', 'mean DBP', 'Haemodynamics Response', 'mean intraoperative propofol', 'mean heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",40.0,0.0442747,The mean DBP of Group B remained significantly lower than that of Group A in different follow up except at 30 minutes and 60 minutes after dura incision.,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Kamal', 'Affiliation': 'Dr Md Mustafa Kamal, Associate Professor, Department of Anaesthesia, Analgesia and Intensive Care Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh; E-mail: kamalanaes64@gmail.com.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'Chowdhury', 'Affiliation': ''}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Islam', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hossain', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Akhtaruzzaman', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1223,32506089,Efficacy of Itraconazole in the Prevention of Recurrence of Tinea Versicolor: A Three Year Follow Up.,"Pityriasis versicolor (PV) also known as tinea versicolor, which is chronic and superficial fungal skin disease caused by Malassezia yeasts. A permanent cure may difficult to achieve and this may explain the long-term nature of the disease. Consequently, a preventive treatment regimen may help to prevent the recurrence of pityriasis versicolor. Whether, the recurrence of tinea versicolor could be prevented by monthly itraconazole treatment regimen after a short course of itraconazole therapy. Open treatment followed by a randomized, single blind placebo control trial. Multi-center trial was characterized by an open, active treatment phase with itraconazole followed by a randomized placebo controlled treatment for prevention of recurrence. A total 200 patients (150 male and 50 female) were included in this study and was given 200mg itraconazole daily for 7 days (treatment phase). Patients in whom tinea versicolor was mycologically cured divided into Group A and Group B. Active open treatment was followed by preventive itraconazole treatment 200mg twice daily in Group A and placebo in Group B monthly for 6 consecutive months. The patients were diagnosed clinically and confirmed by Wood's lamp examination and KOH microscopy. Clinical improvement in 90%, negative Wood's lamp examination in 86.5% and Mycological cure in 85.5% were found at the end of open treatment. The mycological cure, 171 subjects were taken into this study for preventive treatment phase and divided into two groups- Group A & Group B. Preventive treatment was given in Group A and placebo in Group B. After the preventive treatment, the end point (After 6 months), clinical improvement, negative Wood's lamp examination and mycological cure were found in 81(90%), 76(84.4%) and 75(83.3%) in Group A and 44(55%), 41(51.3%) and 42(52.5%) in Group B respectively. In preventive treatment phase, 1 patient in Group A did not complete the study. No patient experienced any serious adverse effects. Prevention of recurrence of Pityriasis versicolor with itraconazole is as effective as treatment.",2020,No patient experienced any serious adverse effects.,"['A total 200 patients (150 male and 50 female', ""patients were diagnosed clinically and confirmed by Wood's lamp examination and KOH microscopy"", 'Patients in whom tinea versicolor', '171 subjects', 'Tinea Versicolor']","['itraconazole', 'Itraconazole', 'itraconazole treatment 200mg twice daily in Group A and placebo', 'itraconazole therapy', 'groups- Group A & Group B. Preventive treatment was given in Group A and placebo', 'placebo']","[""clinical improvement, negative Wood's lamp examination and mycological cure"", ""negative Wood's lamp examination"", 'recurrence of pityriasis versicolor', 'Mycological cure', 'serious adverse effects']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0040262', 'cui_str': 'Pityriasis versicolor'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040262', 'cui_str': 'Pityriasis versicolor'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",200.0,0.0235956,No patient experienced any serious adverse effects.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Wahab', 'Affiliation': 'Professor Lt Col Md Abdul Wahab, Professor, Department of Dermatology and Venereology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh; E-mail: wahab_skinvd@yahoo.com.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kamal', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Shahin', 'Affiliation': ''}, {'ForeName': 'R U', 'Initials': 'RU', 'LastName': 'Siddique', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Hassan', 'Affiliation': ''}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Hassan', 'Affiliation': ''}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Haque', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Nandi', 'Affiliation': ''}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Das', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1224,32514756,"Effect of zinc supplementation on quality of life and sleep quality in young women with premenstrual syndrome: a randomized, double-blind, placebo-controlled trial.","INTRODUCTION


Premenstrual syndrome is a prevalent disorder affecting a large number of women in their reproductive ages. Nutritional importance of zinc has been known for a long time and studies have shown that zinc can positively affect psychological disorders.
PURPOSE


The aim of this study was to evaluate the effects of zinc supplementation on quality of life and sleep quality of young women diagnosed with premenstrual syndrome.
METHODS


This randomized, double-blind, placebo-controlled trial was carried out on 60 young university women that were allocated into two groups of intervention who took 30 mg/day of elemental zinc or placebo for three months. Pre- and post-intervention, participants completed the questionnaires of quality of life and Pittsburgh sleep quality.
RESULTS


After supplementation, quality of life score in the intervention group was increased (+ 9.185 ± 7.29, P < 0.001), however, in comparison with the control group, results were not significant; Physical aspects of quality of life score were significantly enhanced (+ 5.55 ± 3.71 vs. + 0.13 ± 2.87, P < 0.001). Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
CONCLUSION


Zinc supplementation for 12 weeks had beneficial effects on physical aspects of quality of life in young women with premenstrual syndrome.",2020,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
","['60 young university women', 'young women with premenstrual syndrome', 'young women diagnosed with premenstrual syndrome']","['Zinc supplementation', 'elemental zinc or placebo', 'zinc supplementation', 'Pre- and post-intervention', 'placebo']","['quality of life', 'questionnaires of quality of life and Pittsburgh sleep quality', 'quality of life score', 'quality of life and sleep quality', 'Physical aspects of quality of life score', 'Sleep quality']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",60.0,0.426181,"Sleep quality was marginally improved just in the zinc group (- 1.48 ± 4.12, P = 0.07).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Farhang', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. r_amani@nutr.mui.ac.ir.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05628-w']
1225,32515255,"Correction to: Oxygen Exposure During Cardiopulmonary Resuscitation Is Associated With Cerebral Oxidative Injury in a Randomized, Blinded, Controlled, Preclinical Trial.",,2020,,[],['Oxygen Exposure During Cardiopulmonary Resuscitation'],[],[],"[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",[],,0.130556,,[],Journal of the American Heart Association,['10.1161/JAHA.119.014549']
1226,32522198,Left ventricular functional recovery of infarcted and remote myocardium after ST-segment elevation myocardial infarction (METOCARD-CNIC randomized clinical trial substudy).,"BACKGROUND


We aimed to evaluate the effect of early intravenous metoprolol treatment, microvascular obstruction (MVO), intramyocardial hemorrhage (IMH) and adverse left ventricular (LV) remodeling on the evolution of infarct and remote zone circumferential strain after acute anterior ST-segment elevation myocardial infarction (STEMI) with feature-tracking cardiovascular magnetic resonance (CMR).
METHODS


A total of 191 patients with acute anterior STEMI enrolled in the METOCARD-CNIC randomized clinical trial were evaluated. LV infarct zone and remote zone circumferential strain were measured with feature-tracking CMR at 1 week and 6 months after STEMI.
RESULTS


In the overall population, the infarct zone circumferential strain significantly improved from 1 week to 6 months after STEMI (- 8.6 ± 9.0% to - 14.5 ± 8.0%; P < 0.001), while no changes in the remote zone strain were observed (- 19.5 ± 5.9% to - 19.2 ± 3.9%; P = 0.466). Patients who received early intravenous metoprolol had significantly more preserved infarct zone circumferential strain compared to the controls at 1 week (P = 0.038) and at 6 months (P = 0.033) after STEMI, while no differences in remote zone strain were observed. The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001). In patients who developed adverse LV remodeling (defined as ≥ 20% increase in LV end-diastolic volume) remote zone circumferential strain worsened between 1 week and 6 months after STEMI (P = 0.036), while in the absence of adverse LV remodeling no significant changes in remote zone strain were observed.
CONCLUSIONS


Regional LV circumferential strain with feature-tracking CMR allowed comprehensive evaluation of the sequelae of an acute STEMI treated with primary percutaneous coronary intervention and demonstrated long-lasting cardioprotective effects of early intravenous metoprolol.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01311700. Registered 8 March 2011 - Retrospectively registered.",2020,"The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001).","['191 patients with acute anterior STEMI enrolled', 'Left ventricular functional recovery of infarcted and remote myocardium after ST-segment elevation myocardial infarction']",['metoprolol'],"['preserved infarct zone circumferential strain', 'LV infarct zone and remote zone circumferential strain', 'adverse LV remodeling', 'remote zone strain', 'LV end-diastolic volume) remote zone circumferential strain', 'infarct zone circumferential strain', 'MVO or IMH', 'microvascular obstruction (MVO), intramyocardial hemorrhage (IMH) and adverse left ventricular (LV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",191.0,0.133452,"The infarct zone circumferential strain was significantly impaired in patients with MVO and IMH compared to those without (P < 0.001 at 1 week and 6 months), however it improved between both time points regardless of the presence of MVO or IMH (P < 0.001).","[{'ForeName': 'Tomaž', 'Initials': 'T', 'LastName': 'Podlesnikar', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pizarro', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernández-Jiménez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Montero-Cabezas', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Greif', 'Affiliation': 'Faculty of Medicine University of Maribor, Maribor, Slovenia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-González', 'Affiliation': 'Philips Healthcare, Madrid, Spain.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bucciarelli-Ducci', 'Affiliation': 'Bristol Heart Institute, Bristol NIHR Cardiovascular Research Centre, University of Bristol and University Hospitals Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Nina Ajmone', 'Initials': 'NA', 'LastName': 'Marsan', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Delgado', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands. v.delgado@lumc.nl.'}]",Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance,['10.1186/s12968-020-00638-8']
1227,32534080,Photographic assessment of postsurgical facial scars epidermally sutured with rapidly absorbable polyglactin 910 or nylon: A randomized clinical trial.,"BACKGROUND


Surgeons use absorbable and nonabsorbable sutures for epidermal wound closure. No large, randomized studies have compared the effect of these suture types on facial scar appearance.
OBJECTIVE


To assess postsurgical facial scar appearance using either rapidly absorbable polyglactin 910 or nylon for epidermal closure.
METHODS


Randomized, blinded, split-scar clinical trial. A total of 105 patients with facial wounds resulting from Mohs micrographic surgery excisions were randomly assigned for epidermal closure with rapidly absorbable 5-0 polyglactin 910 (Vicryl Rapide) on one half of the repair and 5-0 nylon (Ethilon) on the other half. Two physicians (1 dermatologist and 1 plastic surgeon), unaware of the original suture location, examined photographs of each healed wound at 6 months after surgery and graded the appearance of each half of the scar using the visual analog scale, wound evaluation scale, and Stony Brook Scar Evaluation Scale.
RESULTS


At 6 months, there was no significant difference in the combined mean (standard deviation) visual analog scale scores (83.1 [14.2] and 83.0 [13.7]), Stony Brook Scar Evaluation Scale scores (4.3 [0.9] and 4.4 [0.9]), or wound evaluation scale scores (5.3 [1.1] and 5.2 [1.1]) for rapidly absorbable polyglactin 910 versus nylon (P = .72, .57, and .21, respectively).
LIMITATIONS


Single institution.
CONCLUSIONS


Both rapidly absorbable polyglactin 910 and nylon sutures placed through the epidermis resulted in an equivalent photographic appearance of facial scars at 6 months after surgery.",2020,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,['105 patients with facial wounds resulting from MMS excisions'],"['rapidly-absorbable polyglactin 910 or nylon', 'absorbable and non-absorbable sutures', 'epidermal closure using rapidly-absorbable 5-0 polyglactin 910 (Vicryl Rapide™) on one half of the repair, and 5-0 nylon (Ethilon™) on the other half', 'Photographic assessment of post-surgical facial scars epidermally sutured with rapidly-absorbable polyglactin 910 or nylon']","['equivalent photographic appearance of facial scars', 'visual analog scale (VAS), wound evaluation scale (WES), and Stony Brook scar evaluation scale (SBSES', 'WES scores', 'combined mean (SD) VAS scores', 'facial scar appearance']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025706', 'cui_str': 'Methylmesilate'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0032495', 'cui_str': 'Polygalactin 910'}, {'cui': 'C0028736', 'cui_str': 'Nylon'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205863', 'cui_str': 'Ethilon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C2229249', 'cui_str': 'Scar of face'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",105.0,0.110754,Both rapidly-absorbable polyglactin 910 and nylon sutures placed through epidermis resulted in an equivalent photographic appearance of facial scars at six-months postoperatively.,"[{'ForeName': 'Benvon', 'Initials': 'B', 'LastName': 'Moran', 'Affiliation': ""Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada; Division of Dermatology, Queen's University, Kingston, Ontario, Canada. Electronic address: benvon.moran@queensu.ca.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Humphrey', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Seal', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berkowitz', 'Affiliation': 'Sauder School of Business, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zloty', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, Canada.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.016']
1228,32535138,The effects of foam roll on perceptual and performance recovery during a futsal tournament.,"The present study investigated the efficacy of recovery by foam rolling (FR) on performance, psychological, and physiological parameters of futsal players in a simulated futsal tournament. In this randomized controlled trial design, four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches). Sixteen youth futsal players from two teams (age: 19.1 ± 1.3 years old) were randomly distributed into two groups: (i) passive recovery (PR); and (ii) FR recovery. The FR recovery protocol consisted of five repetitions of 40 s separated by 20 s of rest on calf, quadriceps, hamstrings, and gluteus muscles 5 min after each match. The other group rested passively during the same period. The Yo-Yo intermittent recovery level 2, repeated sprint ability, vertical jump, and PRO agility tests were assessed pre- and post-tournament. Also, Hooper index (HI) and blood lactate concentrations were measured throughout matchdays. Data were analyzed by a repeated measure ANOVA and ANCOVA. Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05). Although FR recovery was slightly beneficial when compared to PR attenuated decrements in aerobic (-1.6%vs-9.7%) and anaerobic performance (-4.5%vs-1.3%), vertical jump (-1.6%vs-3.0%), and change of direction (-2.1%vs-4.3%), these effects were not statistically significant (p>0.05). The finding showed using FR during compact competitions expedites physical performance recovery, increases blood lactate clearance and leads to regenerate psychological characteristics. Therefore, along with other desirable recovery strategies, the use of FR could be recommended in short-term compacted futsal tournaments.",2020,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"['Sixteen youth futsal players from two teams (age: 19.1±1.3 years old', ""four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches"", 'futsal players in a simulated futsal tournament']","['passive recovery (PR); and (ii) FR recovery', 'foam rolling (FR', 'foam roll']","['Hooper index (HI) and blood lactate concentrations', 'perceptual and performance recovery', 'repeated sprint ability, vertical jump, and PRO agility tests', 'lactate removal', 'blood lactate clearance', 'anaerobic performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0276004,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347, Viana do Castelo, Portugal; Instituto de Telecomunicações, Delegação da Covilhã, Lisboa 1049-001, Portugal. Electronic address: filipeclemente@esdl.ipvc.pt.""}]",Physiology & behavior,['10.1016/j.physbeh.2020.112981']
1229,32542307,Effect of daily 2000 IU versus 800 IU vitamin D on blood pressure among adults age 60 years and older: a randomized clinical trial.,"BACKGROUND


Observational studies report higher blood pressure (BP) among individuals with lower 25-hydroxyvitamin D concentration. Whether dosage of vitamin D supplementation has a differential effect on BP control remains unclear.
OBJECTIVE


The study aimed to determine if daily vitamin D supplementation with 2000 IU is more effective than 800 IU for BP control among older adults.
METHODS


This randomized, double-blind, ancillary trial of the Zurich Multiple Endpoint Vitamin D Trial in Knee Osteoarthritis enrolled adults aged ≥60 y who underwent elective surgery due to severe knee osteoarthritis. Participants were randomly assigned to receive high dose (2000 IU) or standard dose (800 IU) daily vitamin D3 for 24 mo. Outcomes included daytime and 24-h mean systolic BP. BP variability and serum 25-hydroxyvitamin D concentration were examined in a post hoc and observational analysis.
RESULTS


Of the 273 participants randomly assigned, 250 participants completed a follow-up 24-h ambulatory BP monitoring (mean age: 70.4 ± 6.4 y; 47.2% men). The difference in daytime mean systolic BP reduction between the 2000 IU (n = 123) and 800 IU (n = 127) groups was not statistically significant (-2.75 mm Hg vs. -3.94 mm Hg; difference: 1.18 mm Hg; 95% CI: -0.68, 3.05; P = 0.21), consistent with 24-h mean systolic BP. However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI: -0.94, -0.01; P = 0.045). Independent of group allocation, maximal reductions in mean BP were observed at 28.7 ng/mL of achieved serum 25-hydroxyvitamin D concentrations.
CONCLUSIONS


While daily 2000 IU and 800 IU vitamin D3 reduced mean systolic BP over 2 y to a small and similar extent, 2000 IU reduced mean systolic BP variability significantly more compared with 800 IU. However, without a placebo control group we cannot ascertain whether vitamin D supplementation effectively reduces BP.This trial was registered at www.clinicaltrials.gov as NCT00599807.",2020,"However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI:","['older adults', 'individuals with lower 25-hydroxyvitamin D concentration', 'Knee Osteoarthritis enrolled adults aged ≥60 y who underwent elective surgery due to severe knee osteoarthritis', 'adults age 60 years and older', '273 participants randomly assigned', '250 participants completed a follow-up 24-h ambulatory BP monitoring (mean age: 70.4\xa0±\xa06.4 y; 47.2% men']","['daily vitamin D supplementation', '800 IU vitamin D', 'Zurich Multiple Endpoint Vitamin D Trial', 'vitamin D supplementation', 'vitamin D3']","['blood pressure', 'mean BP', '24-h mean systolic BP', 'daytime and 24-h mean systolic BP', 'systolic BP variability', 'BP variability and serum 25-hydroxyvitamin D concentration', 'blood pressure (BP', 'mean systolic BP', 'mean systolic BP variability', 'serum 25-hydroxyvitamin D concentrations', 'daytime mean systolic BP reduction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",273.0,0.705876,"However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI:","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Abderhalden', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ursina', 'Initials': 'U', 'LastName': 'Meyer', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Godoi Rezende Costa Molino', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hannes B', 'Initials': 'HB', 'LastName': 'Stähelin', 'Affiliation': 'Department of Geriatrics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Forman', 'Affiliation': ""Department of Nephrology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa145']
1230,32542334,"A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study.","BACKGROUND


With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms.
OBJECTIVES


The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial.
METHODS


We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study.
RESULTS


Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
CONCLUSIONS


Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects.Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).",2020,"The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
",['adults with eye fatigue'],"['novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry', 'placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein', 'placebo']","['visuognosis persistence time', 'individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing', 'tear break-up time, average tear break-up time, and tear meniscus height', 'eye fatigue, dry eye, and macular function', 'total score of eye fatigue symptoms', 'tear secretion', 'eye fatigue and dry eye', 'retinal thickness and retinal volume', 'macular pigment optical density']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0873128', 'cui_str': 'LUTEIN ESTERS'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0008720', 'cui_str': 'Chrysanthemum'}, {'cui': 'C1088997', 'cui_str': 'Goji Berry Plant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0304290', 'cui_str': 'Chewable tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0863081', 'cui_str': 'Soreness in eyes'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}]",360.0,0.320918,"The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits.
","[{'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Aier Eye Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Vanderbilt Epidemiology Center, Division of Epidemiology, Department of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}, {'ForeName': 'Chengrong', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'School of Pharmacy, Fudan University, Shanghai, China.'}, {'ForeName': 'Bryan Y', 'Initials': 'BY', 'LastName': 'Liu', 'Affiliation': 'College of Biotechnology, East China University of Science and Technology, Shanghai, China.'}, {'ForeName': 'Zhensheng', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': 'Department of Ophthalmology, Xinhua Hospital, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Nutrilite Health Institute, Shanghai, China.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa139']
1231,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND


Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate.
OBJECTIVE


This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game.
PARTICIPANTS AND SETTING


The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia.
METHOD


All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34).
RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not.
CONCLUSIONS


This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS


Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569']
1232,32682995,The impact of narratives and active video games on long-term moderate-to-vigorous physical activity: A randomized controlled trial protocol.,"BACKGROUND


Although physical activity (PA) has been shown in helping prevent and treat obesity, current PA interventions are still not effective in ameliorating the obesity epidemic. Additional forms of PA need to be investigated to improve PA engagement and outcomes. We hypothesize that pairing a narrative (i.e., story) with an active video game (AVG), a less traditional form of PA, will increase participant engagement in PA. This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes.
OBJECTIVE


This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes.
METHODS/DESIGN


The Active Video Game Study is a six-month randomized controlled single-blind trial projected to include 210 participants. The intervention strategy will pair a narrative to an active video game (AVG). Participants will be randomized into 3 groups: condition A [Narrative + AVG], condition B [AVG Only], and condition C [Control]. Participants will undergo three in-person data collection visits over the course of six months. Inclusion criteria are that children are between the ages of 8-12 and have a BMI ≥ 85%. The primary outcome is change in moderate to vigorous physical activity (MVPA). Secondary outcome measures include change in BMI percentile, fasting insulin and glucose, lipid panel, C-reactive protein, and cognitive function. A pilot trial of n = 6 was conducted to help develop procedures and address problems that could arise in the main trial.
DISCUSSION


Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.",2020,Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.,"['210 participants', 'long-term moderate-to-vigorous physical activity']","['physical activity (PA', 'narratives and active video games', 'condition A [Narrative + AVG], condition B [AVG Only], and condition C [Control']","['change in moderate to vigorous physical activity (MVPA', 'change in BMI percentile, fasting insulin and glucose, lipid panel, C-reactive protein, and cognitive function']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",210.0,0.130661,Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.,"[{'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Alon', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': 'Distinguished Emeritus Professor, Baylor College of Medicine, 1100 Bates St, Houston, TX 77030, United States.'}, {'ForeName': 'Tiago V', 'Initials': 'TV', 'LastName': 'Barreira', 'Affiliation': 'Exercise Science Department, Syracuse University, 820 Comstock Ave, Syracuse, NY 13244, United States.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Cabrera-Perez', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Chiu', 'Affiliation': 'Harvard Medical School, Primary Care Martha Eliot, 75 Bickford St, Jamaica Plain, MA 02478, United States.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fleischman', 'Affiliation': ""Harvard Medical School, Optimal Wellness for Life Clinic, Boston Children's Hospital, Boston, MA 02115, United States.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Floating Hospital for Children at Tufts Medical Center, Boston, MA 02111, United States.'}, {'ForeName': 'Jungyun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, Stanford University Medical Center, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Melanie C', 'Initials': 'MC', 'LastName': 'Green', 'Affiliation': 'Department of Communication, University at Buffalo, 359 Baldy Hall, Buffalo, NY 14260, United States.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02215, United States.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lessard', 'Affiliation': ""Research Division, Joslin Diabetes Center, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02215, United States.""}, {'ForeName': 'Lynne L', 'Initials': 'LL', 'LastName': 'Levitsky', 'Affiliation': 'Pediatric Endocrinology, Massachusetts General Hospital, Pediatrics, Harvard Medical School, 175 Cambridge St 5(th) Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Aika', 'Initials': 'A', 'LastName': 'Misawa', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Noubary', 'Affiliation': 'Department of Health Sciences, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Samuels', 'Affiliation': ""Children's Hospital Primary Care Center, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, United States.""}, {'ForeName': 'Kyung Jin', 'Initials': 'KJ', 'LastName': 'Sun', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, 1100 Bates Avenue, Houston, TX 77030, United States.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Lu', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States. Electronic address: a.lu@northeastern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106087']
1233,32544161,Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe.,"BACKGROUND


Voluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up.
METHODS


The RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively.
RESULTS


Clients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts.
CONCLUSION


Results strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.",2020,"Wage and age did not influence text response rates or potential AE texts.
","['100 texting clients filled a self-administered usability survey on day 14', 'post-operative follow-up for voluntary medical male circumcision in Zimbabwe', '362 adult MC clients with cell phones into 2wT; these men', 'Men with concerns solicited provider guidance and reassurance offered via text']",[],"['Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality', '2wT acceptability and usability', 'Response rates', 'Usability and acceptability', 'Clients felt 2wT saved them time and money']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1136359', 'cui_str': 'Cellular Phone'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0204558', 'cui_str': 'Group reassurance'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]",[],"[{'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",362.0,0.0385762,"Wage and age did not influence text response rates or potential AE texts.
","[{'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korir', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Wambua', 'Affiliation': 'Medic Mobile, Nairobi, Kenya.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.'}, {'ForeName': 'Marrianne', 'Initials': 'M', 'LastName': 'Holec', 'Affiliation': 'International Training and Education Center for Health (I-TECH), Seattle, WA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe.'}]",PloS one,['10.1371/journal.pone.0233234']
1234,32556585,Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study.,"PURPOSE


To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. Decompression of the nerve roots is the main surgical treatment for lumbar spinal stenosis. The aim of this study was to radiologically investigate three commonly used posterior decompression techniques.
METHODS


The present study reports data from one of two multicenter randomized trials included in the NORDSTEN study. In the present trial, involving 437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n = 146), bilateral laminotomy (BL) (n = 142) and spinous process osteotomy (SPO) (n = 149). MRI was performed before and three months after surgery. The increase in dural sac area and Schizas grade at the most stenotic level was evaluated. Three different predefined surgical indicators of substantial decompression were used: (1) postoperative dural sac area of > 100 mm 2 , (2) increase in the dural sac area of at least 50% and (3) postoperative Schizas grade A or B.
RESULTS


No differences between the three surgical groups were found in the mean increase in dural sac area. Mean values were 66.0 (SD 41.5) mm 2  in the UL-group, 71.9 (SD 37.1) mm 2  in the BL-group and 68.1 (SD 41.0) mm 2  in the SPO-group (p = 0.49). No differences in the three predefined surgical outcomes between the three groups were found.
CONCLUSION


For patients with lumbar spinal stenosis, the three different surgical techniques provided the same increase in dural sac area.
CLINICAL TRIAL REGISTRATION


The study is registered at ClinicalTrials.gov reference on November 22th 2013 under the identifier NCT02007083.",2020,No differences between the three surgical groups were found in the mean increase in dural sac area.,"['437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n\u2009=\u2009146', 'patients with lumbar spinal stenosis', 'patients undergoing surgery for lumbar spinal stenosis', 'lumbar spinal stenosis']","['posterior decompression techniques', 'bilateral laminotomy (BL) (n\u2009=\u2009142) and spinous process osteotomy (SPO']","['Mean values', 'dural sac area', 'dural sac area and\xa0Schizas grade', 'dural sac area of at least 50% and (3) postoperative Schizas grade A or B']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}]",437.0,0.0565306,No differences between the three surgical groups were found in the mean increase in dural sac area.,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Hermansen', 'Affiliation': 'Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway. Erland.hermansen@helse-bergen.no.'}, {'ForeName': 'Ivar Magne', 'Initials': 'IM', 'LastName': 'Austevoll', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hellum', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Communication and Research Unit for Musculoskeletal Health (FORMI), Oslo University Hospital,, Oslo, Norway.'}, {'ForeName': 'Tor Åge', 'Initials': 'TÅ', 'LastName': 'Myklebust', 'Affiliation': 'Department of Research and Innovation, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Aaen', 'Affiliation': 'Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Diagnostic Imaging, Akershus University Hospital,, Oslo, Norway.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Anvar', 'Affiliation': 'Unilabs Radiology, Oslo, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Rekeland', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Franssen', 'Affiliation': 'Department of Orthopaedics, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Weber', 'Affiliation': 'Department of Neurosurgery, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Solberg', 'Affiliation': 'Department of Neurosurgery and the Norwegian Registry for Spine Surgery (NORspine), University Hospital of Northern Norway, Tromsö, Norway.'}, {'ForeName': 'Knut Jørgen', 'Initials': 'KJ', 'LastName': 'Haug', 'Affiliation': 'Departement of Orthopedic Surgery, Telemark Regional Hospital, Skien, Norway.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grundnes', 'Affiliation': 'Department of Orthopedics, Akershus University Hospital, Oslo, Norway.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brisby', 'Affiliation': 'Department of Orthopaedics, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Indrekvam', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06499-0']
1235,32445184,Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program.,"INTRODUCTION


Etrolizumab is a next-generation anti-integrin with dual action that targets two pathways of inflammation in the gut. A robust phase 3 clinical program in ulcerative colitis (UC) and Crohn's disease is ongoing and will evaluate the efficacy and safety of etrolizumab in well-defined patient populations in rigorous trials that include direct head-to-head comparisons against approved anti-tumor necrosis factor alpha agents (anti-TNF). The etrolizumab phase 3 clinical program consists of six randomized controlled trials (RCTs; UC: HIBISCUS I and II, GARDENIA, LAUREL, HICKORY; Crohn's disease: BERGAMOT) and two open-label extension trials (OLEs; UC: COTTONWOOD; Crohn's disease: JUNIPER) evaluating patients with moderately to severely active UC or Crohn's disease.
METHODS


In the UC RCTs, patients are randomly assigned according to each protocol to receive etrolizumab, adalimumab, infliximab, or placebo. In BERGAMOT, patients are randomly assigned to receive etrolizumab 105 mg, etrolizumab 210 mg, or placebo. The primary outcomes for the UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease). The OLEs will primarily assess long-term efficacy and safety. Secondary and exploratory endpoints include endoscopy, histology, quality of life, and biomarkers at various timepoints.
DISCUSSION


The etrolizumab phase 3 clinical program is the largest and most comprehensive in inflammatory bowel disease, enrolling more than 3000 patients. The program explores both induction and maintenance regimens. HIBISCUS I and II and GARDENIA are among the first head-to-head trials in UC against an anti-TNF and are the first registrational trials making that comparison. This program will also help address unanswered clinical questions on evaluation of treatment effects and treatment selection across a range of patients with varying treatment histories using an extensive repository of patient samples and data.
TRIAL REGISTRATION


ClinicalTrials.gov: HIBISCUS I (NCT02163759), HIBISCUS II (NCT02171429), GARDENIA (NCT02136069), LAUREL (NCT02165215), HICKORY (NCT02100696), COTTONWOOD (NCT02118584), BERGAMOT (NCT02394028), JUNIPER (NCT02403323).",2020,HIBISCUS ,"['3000 patients', ""Ulcerative Colitis and Crohn's Disease"", ""patients with moderately to severely active UC or Crohn's disease""]","['Etrolizumab', 'etrolizumab, adalimumab, infliximab, or placebo', 'etrolizumab 105\xa0mg, etrolizumab 210\xa0mg, or placebo', 'etrolizumab']","[""UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease"", 'endoscopy, histology, quality of life, and biomarkers at various timepoints']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.181287,HIBISCUS ,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrrell', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lacey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Tole', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Tatro', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland. amanda.tatro@roche.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01366-2']
1236,32320482,Using Healthcare Databases to Replicate Trial Findings for Supplemental Indications: Adalimumab in Patients with Ulcerative Colitis.,"Regulators wish to understand whether real world evidence can be used for secondary indications of biologics. Using the secondary indication of adalimumab for ulcerative colitis (UC) as an example, we aimed to replicate the ULTRA-2 randomized controlled trial finding on the effectiveness of adalimumab in patients with UC using realworld data analyses. Adalimumab, a TNF-alpha receptor inhibitor initially approved for Crohn's disease, was approved for moderate to severe UC in 2012. The ULTRA-2 trial had shown improved remission against placebo in patients with UC. Using claims data (2006-2012), we conducted a cohort study of patients with UC who initiated adalimumab and compared them with (i) nonusers and (ii) new users of infliximab using propensity score matching. The coprimary end points were corticosteroid (CS) discontinuation within 8 weeks and 1 year of treatment. We computed hazard ratios (HRs) and 95% confidence intervals (CIs). We identified 398 matched pairs of adalimumab users vs. nonusers and 326 pairs of adalimumab vs. infliximab users. Adalimumab users were 28% more likely to achieve CS-discontinuation compared with nonusers over 1 year (HR = 1.28; 95% CI 0.94-1.73). However, unlike in ULTRA-2, this effect was not observed in the first 8 weeks (HR = 0.79; 95% CI 0.65-0.97). Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment. In summary, our results highlight opportunities and some limitations of database analysis to identify treatment effects for secondary indications.",2020,"Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment.","['398 matched pairs of adalimumab users vs. nonusers and 326 pairs of adalimumab vs. infliximab users', 'patients with UC who initiated adalimumab and compared them with (i) nonusers and (ii) new users of', 'ulcerative colitis (UC', 'patients with UC using realworld data analyses', 'Patients with Ulcerative Colitis', 'patients with UC']","['adalimumab', 'Adalimumab', 'infliximab', 'infliximab, adalimumab', 'placebo']","['CS-discontinuation', 'corticosteroid (CS) discontinuation']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.17633,"Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Spoendlin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Desai', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Franklin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Payne', 'Affiliation': 'Aetion Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schneeweiss', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1861']
1237,32449213,"Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.","OBJECTIVE


To evaluate the impact of lasmiditan, an oral, centrally-penetrant, selective serotonin 1F (5-HT 1F  ) receptor agonist developed for the acute treatment of migraine, on simulated driving.
METHODS


Healthy adult volunteers enrolled in two randomized, placebo and active comparator-controlled, crossover studies. Study 1 (N = 90) tested lasmiditan (50-, 100-, 200-mg), alprazolam (1-mg), and placebo at 1.5 hr post-dose. Study 2 (N = 68) tested lasmiditan (100-, 200-mg), diphenhydramine (50-mg, administered 2 hr pre-assessments), and placebo at 8, 12 and 24 hr post-dose. Driving performance was assessed using a validated driving simulator employing a 100 km driving scenario. Standard deviation of lateral position (SDLP), a measure of lane position control, was the primary endpoint.
RESULTS


Assay sensitivity was confirmed by increased SDLP for active comparators at 1.5- and 8-hr time points. Lasmiditan doses showed significant driving impairment versus placebo at 1.5 hr post-dose. Lasmiditan doses were non-inferior to placebo at 8 hr. Driving impairment was concentration-dependent at 1.5 hr but not at 8 hr. Common adverse events were central nervous system-related and mild-to-moderate in severity.
CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.",2020,"CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.",['Healthy adult volunteers enrolled in two randomized'],"['lasmiditan', 'lasmiditan ', 'alprazolam (1-mg), and placebo', 'lasmiditan (100-, 200-mg), diphenhydramine', 'placebo']","['Driving performance', 'simulated driving performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]",,0.377978,"CONCLUSIONS


Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Wilbraham', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ellen B', 'Initials': 'EB', 'LastName': 'Dennehy', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Berg', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly & Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corporation, St. Petersburg, Florida, USA.'}]",Human psychopharmacology,['10.1002/hup.2732']
1238,32452846,Cardiogenic shock: role of invasive cardiology.,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI). Nevertheless, the mortality remains substantial, ranging between 40 and 50% after 30 days. The present review summarizes the current evidence regarding revascularization strategies, vascular access site and concomitant antiplatelet and antithrombotic treatment in infarct-related cardiogenic shock.
RECENT FINDINGS


On the basis of the SHOCK trial, early revascularization is the most relevant procedure to improve the outcome of patients with infarct-related cardiogenic shock. The majority of these patients present with multivessel coronary disease. The randomized CULPRIT-SHOCK trial showed that in the emergency setting, percutaneous coronary intervention (PCI) should be confined to the culprit lesion. Regarding vascular access site, no data derived from randomized controlled trials in cardiogenic shock are available. Emergency coronary artery bypass grafting (CABG) is nowadays rarely performed in cardiogenic shock with rates less than 5% but is still a treatment option if coronary anatomy is not amenable to PCI. Regarding antiplatelet treatment, a randomized trial testing the intravenous P2Y12 inhibitor cangrelor versus an oral P2Y12 inhibitor in infarct-related cardiogenic shock is currently being performed.
SUMMARY


Early revascularization is the cornerstone of treatment of infarct-related cardiogenic shock and should be confined to the culprit lesion in the emergency setting.",2020,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","['patients with cardiogenic shock following acute myocardial infarction (AMI', 'patients with infarct-related cardiogenic shock']","['percutaneous coronary intervention (PCI', 'Emergency coronary artery bypass grafting (CABG', 'intravenous P2Y12 inhibitor cangrelor']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1532296', 'cui_str': 'Emergency CABG'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121991', 'cui_str': 'cangrelor'}]",[],,0.1286,"PURPOSE OF REVIEW


Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","[{'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at the University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': ''}]",Current opinion in critical care,['10.1097/MCC.0000000000000738']
1239,32453306,Chronopharmacokinetics and Food Effects of Single-Dose LCP-Tacrolimus in Healthy Volunteers.,"BACKGROUND


A modified-release version of tacrolimus, LCP-tacrolimus (LCPT; Envarsus XR, Veloxis Pharmaceuticals, Cary, NC), has been licensed in the United States for prophylaxis of organ rejection in de novo kidney transplant patients. As tacrolimus has a narrow therapeutic window, the impact of circadian patterns on LCPT drug exposure, including food and chronopharmacokinetic effects, needs to be elucidated to optimize dosing.
METHODS


Two randomized, crossover, phase 1 studies were conducted in healthy volunteers. The first assessed the effect of morning versus evening dosing on the pharmacokinetic profile of LCPT 2 mg; the second assessed the effect of food on the pharmacokinetic profile of LCPT 5 mg. In both, blood samples were drawn from participants for up to 144 hours after administration of a single LCPT dose.
RESULTS


No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 versus 4.0 ng/mL; P = 0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 versus 102.6 ng/mL; P = 0.20), AUC from time 0 to infinity (99.7 versus 114.3 ng·h/mL; P = 0.18), AUC from 0 to 24 hours post-dose (AUC0-24; 49.4 versus 51.6 ng·h/mL; P = 0.56), time to reach maximum blood concentration (median, 6.0 versus 6.0 hours; P = 0.91), total clearance (arithmetic mean = 21.5 versus 19.5 L/h; P = 0.50), or terminal half-life (arithmetic mean = 26.8 versus 28.1 hours; P = 0.26). After a high-calorie meal in the morning, the AUC0-24 reduced by 54% (ratio of geometric means = 45.6%; P < 0.0001) and peak blood concentration reduced by 22% (ratio of geometric means = 78.4%; P = 0.0006). However, the terminal half-life did not differ between fasted and fed states (33.3 versus 34.8 hours; P = 0.16), implying that these differences occurred because of altered bioavailability rather than modified clearance.
CONCLUSIONS


For LCPT, no chronopharmacokinetic effects were observed, whereas food significantly reduced the 24-h exposure and the peak blood concentration.",2020,"No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 vs. 4.0 ng/mL; p=0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 vs. 102.6 ng/mL; p=0.20), AUC from time 0 to infinity (99.7 vs. 114.3 ng·h/mL; p=0.18), AUC from 0 to 24 h post-dose (AUC0-24; 49.4 vs. 51.6 ng·h/mL; p=0.56), time to reach maximum blood concentration (median, 6.0 vs. 6.0 h; p=0.91), total clearance (arithmetic mean = 21.5 vs. 19.5 L/h; p=0.50), or terminal half-life (arithmetic mean = 26.8 vs. 28.1 h; p=0.26).","['Healthy Volunteers', 'novo kidney transplant patients', 'healthy volunteers']","['Single-Dose LCP-tacrolimus', 'tacrolimus', 'tacrolimus, LCP-tacrolimus (LCPT']","['total clearance', '24-h exposure and the peak blood concentration', 'time to reach maximum blood concentration', 'area under the time-concentration curve (AUC', 'peak blood concentration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.169971,"No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 vs. 4.0 ng/mL; p=0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 vs. 102.6 ng/mL; p=0.20), AUC from time 0 to infinity (99.7 vs. 114.3 ng·h/mL; p=0.18), AUC from 0 to 24 h post-dose (AUC0-24; 49.4 vs. 51.6 ng·h/mL; p=0.56), time to reach maximum blood concentration (median, 6.0 vs. 6.0 h; p=0.91), total clearance (arithmetic mean = 21.5 vs. 19.5 L/h; p=0.50), or terminal half-life (arithmetic mean = 26.8 vs. 28.1 h; p=0.26).","[{'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Alloway', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Trofe-Clark', 'Affiliation': 'Department of Pharmacy, Hospital of the University of Pennsylvania and Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Brennan', 'Affiliation': 'Comprehensive Transplant Center, The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'UC San Diego Health, San Diego, California.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Cohen', 'Affiliation': 'Department of Transplantation, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Meier-Kriesche', 'Affiliation': 'Medical Affairs Department, Veloxis Pharmaceuticals, Cary, North Carolina.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Stevens', 'Affiliation': 'Medical Affairs Department, Veloxis Pharmaceuticals, Cary, North Carolina.'}, {'ForeName': 'Misbah A', 'Initials': 'MA', 'LastName': 'Moten', 'Affiliation': 'Medical Affairs Department, Veloxis Pharmaceuticals, Cary, North Carolina.'}, {'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'Division of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego, La Jolla, California.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000773']
1240,32451179,"Re: Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma (the POUT Trial): A Phase 3, Open-label, Randomised Controlled Trial.",,2020,,['Upper Tract Urothelial Carcinoma (the POUT Trial'],['Re: Adjuvant Chemotherapy'],[],"[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",[],,0.179276,,"[{'ForeName': 'Teele', 'Initials': 'T', 'LastName': 'Kuusk', 'Affiliation': 'Specialist Centre for Kidney Cancer, UCL Division of Surgery and Interventional Science, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Bex', 'Affiliation': 'Specialist Centre for Kidney Cancer, UCL Division of Surgery and Interventional Science, Royal Free London NHS Foundation Trust, London, UK. Electronic address: a.bex@ucl.ac.uk.'}]",European urology,['10.1016/j.eururo.2020.04.021']
1241,32451827,Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial.,"OBJECTIVE


To compare the efficacy of oral paracetamol and oral ibuprofen for the management of acute headache in children with migraine without aura.
METHODS


This randomized-controlled trial was done at the Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6-12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria. The 50 patients (21 females, mean age 9.9 y) consecutively enrolled were randomized by block randomization to two study groups, with one group (n = 25) receiving oral paracetamol (15 mg/kg/dose) and the other group (n = 25) oral ibuprofen (10 mg/kg/dose), at home, during a single episode of acute migraine headache. The study drugs were dispensed in a blinded fashion. Pain-freedom (score of zero in a 0-10 Visual analogue pain scale) and Pain-relief (≥2-point reduction from the baseline) two-hours after the study drug intake were the primary outcomes. Side-effects to the study drugs were actively solicited. Non-parametric tests for paired data were used.
RESULTS


The two groups were similar at baseline. Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study. Both pain-freedom (32% vs. 28%, P = 0.77) and pain-relief (80% vs. 80%, P = 0.86) were not significantly different between the Paracetamol and Ibuprofen groups, respectively. Ten (23.2%) children had a side-effect due to the study drug, with no significant difference between the groups (13.6% vs. 33.3%; P = 0.11).
CONCLUSIONS


Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.",2020,Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.,"['acute migraine attacks in children', '50 patients (21 females, mean age 9.9 y) consecutively enrolled', 'Migraine Headache in Children', 'children with migraine without aura', 'Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6-12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria', 'Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study']","['ibuprofen', 'paracetamol and ibuprofen', 'Ibuprofen', 'Paracetamol versus Ibuprofen', 'oral paracetamol and oral ibuprofen', 'oral paracetamol']","['pain-relief', 'Pain-freedom (score of zero in a 0-10 Visual analogue pain scale) and Pain-relief', 'pain-freedom', 'acute headache']","[{'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}]",43.0,0.160754,Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pavithra', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India. drdmishra@gmail.com.'}, {'ForeName': 'Shatrishna', 'Initials': 'S', 'LastName': 'Behera', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Juneja', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03315-x']
1242,32452344,Baricitinib in patients with rheumatoid arthritis with inadequate response to methotrexate: results from a phase 3 study.,"OBJECTIVES


This study evaluated the efficacy and safety of baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, in patients with moderately to severely active rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX) therapy.
METHODS


In this phase 3, double-blind, 52-week, placebo-controlled study, 290 patients with moderately to severely active RA and inadequate response to MTX were randomly assigned 1:1 to placebo or baricitinib 4-mg once daily, stratified by country (China, Brazil, Argentina) and presence of joint erosions. Primary endpoint measures included American College of Rheumatology 20% response (ACR20) at week 12. Secondary endpoints included changes in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Disease Activity Score for 28-joint counts (DAS28)-high-sensitivity C-reactive protein (hsCRP), Simplified Disease Activity Index (SDAI) score ≤3.3, mean duration of morning joint stiffness, severity of morning joint stiffness numeric rating scale (NRS 0-10), worst tiredness NRS, and worst joint pain NRS at week 12.
RESULTS


Most patients (approximately 80%) were from China. More patients achieved ACR20 response at week 12 with baricitinib than with placebo (58.6% vs. 28.3%; p<0.001). Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12. Through week 24, rates of treatment-emergent adverse events, including infections, were higher for baricitinib compared to placebo, while serious adverse event rates were similar between baricitinib and placebo.
CONCLUSIONS


In patients with RA who had an inadequate response to MTX, baricitinib was associated with significant clinical improvements as compared with placebo.",2020,"Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12.","['290 patients with moderately to severely active RA and inadequate response to MTX', 'patients with rheumatoid arthritis with inadequate response to', 'patients with moderately to severely active rheumatoid arthritis (RA']","['methotrexate (MTX) therapy', 'baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor', 'placebo or baricitinib', 'methotrexate', 'placebo']","['changes in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Disease Activity Score for 28-joint counts (DAS28)-high-sensitivity C-reactive protein (hsCRP), Simplified Disease Activity Index (SDAI) score ≤3.3, mean duration of morning joint stiffness, severity of morning joint stiffness numeric rating scale (NRS 0-10), worst tiredness NRS, and worst joint pain NRS', 'HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain', 'serious adverse event rates', 'American College of Rheumatology 20% response (ACR20', 'rates of treatment-emergent adverse events, including infections', 'ACR20 response']","[{'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0266700', 'cui_str': 'Janiceps'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",290.0,0.435619,"Statistically significant improvements were also seen in HAQ-DI, DAS28-hsCRP, morning joint stiffness, worst tiredness, and worst joint pain in the baricitinib group compared to placebo at week 12.","[{'ForeName': 'Zhanguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Peking University People's Hospital, Beijing, China. li99@bjmu.edu.cn.""}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Jiangxi Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Chunde', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xingfu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Xiangpei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Spindler', 'Affiliation': 'Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Argentina.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Dongyi', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'GuangHua Hospital, Shanghai, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Guochun', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Haoxun', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Lujing', 'Initials': 'L', 'LastName': 'Zhan', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Bai', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Terence P', 'Initials': 'TP', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'CEPIC - Centro Paulista de Investigação Clinica e Serviços Médicos, Ipiranga São Paulo, Brazil.'}]",Clinical and experimental rheumatology,[]
1243,32526017,Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial.,"OBJECTIVE


Although some studies have shown the clinical benefits of therapeutic exercise in chronic nonspecific low back pain, the effect sizes are generally small to moderate and recurrence rates are high. Transcranial direct current stimulation (tDCS) has been used to modulate pain-processing systems and motor outputs and has the potential to optimize the clinical benefits of therapeutic exercise. However, evidence for this combination is still lacking. The purpose of this protocol for a randomized clinical trial is to investigate whether the combination of tDCS and therapeutic exercise is more effective in relieving pain than therapeutic exercise alone.
METHODS


This 2-arm, randomized controlled clinical trial will take place at the Federal University of Piauí, Brazil. Sixty patients will be randomized into 2 groups to receive tDCS (real/sham) + exercise therapies for 12 sessions over a period of 4 weeks. Pain intensity, sensory and affective aspects of pain, physical functioning, kinesiophobia, and global perceived effect will be recorded before treatment and at 4 weeks, 3 months, and 6 months after randomization. Data will be collected by an examiner unaware of (blind to) the treatment allocation.
IMPACT


This trial can potentially provide important information and assist in clinical decision-making on the combined use of tDCS to optimize the clinical benefits of therapeutic exercise in patients with chronic nonspecific low back pain.",2020,,['Chronic Low Back Pain'],"['Transcranial Direct Current Stimulation (tDCS', 'Therapeutic Exercise']",[],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",[],,0.160382,,"[{'ForeName': 'Polyanna Gomes Lacerda', 'Initials': 'PGL', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, PI - Brazil.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Center for Mathematics, Computation and Cognition, Universidade Federal do ABC, São Bernardo do Campo, SP - Brazil.'}, {'ForeName': 'Vinícius Saura', 'Initials': 'VS', 'LastName': 'Cardoso', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui.'}, {'ForeName': 'Marcelo de Carvalho', 'Initials': 'MC', 'LastName': 'Filgueiras', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui.'}, {'ForeName': 'Renata Hydee', 'Initials': 'RH', 'LastName': 'Hasue', 'Affiliation': 'Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Doctoral Programs in Rehabilitation Sciences, Faculdade de Medicina da Universidade de São Paulo - USP, São Paulo, SP - Brazil.'}, {'ForeName': 'Silvia Maria Amado', 'Initials': 'SMA', 'LastName': 'João', 'Affiliation': 'Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Doctoral Programs in Rehabilitation Sciences, Faculdade de Medicina da Universidade de São Paulo.'}, {'ForeName': 'Fuad Ahmad', 'Initials': 'FA', 'LastName': 'Hazime', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, Avenida São Sebastião, 2819, CEP: 64202-020 Parnaíba, PI - Brazil.'}]",Physical therapy,['10.1093/ptj/pzaa105']
1244,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND


External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
OBJECTIVE


To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
METHODS


Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
RESULTS


Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
CONCLUSIONS


ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005']
1245,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND


Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates.
OBJECTIVE


We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation.
METHODS


We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms.
RESULTS


Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013).
CONCLUSIONS


Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007']
1246,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1247,32535558,SURGICAL STABILIZATION OF MULTIPLE RIB FRACTURES AND MULTIPLE LONG BONE FRACTURES OF LOWER EXTREMITIES IN POLYTRAUMA PATIENTS.,"Objectives - determine the impact of rib osteosynthesis on the incidence of complications development and mortality in patients with multiple rib fractures and multiple long bone fractures of lower extremities. A prospective controlled trial was conducted from June 2015 to December 2019, and included adult patients with polytrauma, Injury Severity Score (ISS) ≥18p, multiple long bone fractures of lower extremities, one of which is the femur, and multiple rib fractures. All included patients were divided into two groups: in Group I - 17 patients who underwent surgical stabilization of rib fractures, Group II - 24 included patients treated without rib osteosynthesis. There were no significant statistic differences between patients of Group I and Group II in demographics, mechanism of injury, severity of trauma, and overall patient status. All patients had high rates of injury severity for ISS (37.8±7.9 vs. 36.9±8.6, p=0.863), New Injury Severity Score (NISS) (39.5±9.2 vs. 38.5±7.6, p=0.759) and Glasgow Coma Scale (GCS) (8.2±3.5 vs. 8.7±3.8, p=0.896).The time between trauma and rib osteosynthesis in Group I was 3.4±1.7 days. The period from trauma to definitive long bone osteosynthesis was 6.9±3.2 days in Group I and 9.4±3.8 days in Group II (p=0.039). Patients of Group I compared with Group II had a lower incidence of Acute Respiratory Distress Syndrome (ARDS) (23.5% vs. 54.2%, p=0.049) and pneumonia (29.4% vs. 62,5%, p= 0.038), shorter terms of Mechanical Ventilation (MV) (11.6±9.4 vs. 18.9±9.9, p=0.001), Length Of Stay in Intensive Care Unit (LOS ICU) (15.3±10.2 vs. 22.1±10.8, p=0.003) and Hospital Length Of Stay (HLOS) (36.9±15.8 vs. 44.3±17.4, p=0.001). Use of the rib osteosynthesis in patients with severe polytrauma, multiple rib and long bone of lower extremity fractures is more effective tactic comparing to non-surgical rib fracture treatment, it allows to reduce the incidence of ARDS and pneumonia, decreases the duration of MV, LOS ICU and HLOS.",2020,"There were no significant statistic differences between patients of Group I and Group II in demographics, mechanism of injury, severity of trauma, and overall patient status.","['patients with severe polytrauma, multiple rib and long bone of lower extremity fractures', 'June 2015 to December 2019, and included adult patients with polytrauma, Injury Severity Score (ISS) ≥18p, multiple long bone fractures of lower extremities, one of which is the femur, and multiple rib fractures', 'patients with multiple rib fractures and multiple long bone fractures of lower extremities']","['surgical stabilization of rib fractures, Group II - 24 included patients treated without rib osteosynthesis', 'rib osteosynthesis']","['Acute Respiratory Distress Syndrome (ARDS', 'Glasgow Coma Scale (GCS', 'Mechanical Ventilation (MV', 'New Injury Severity Score (NISS', 'Hospital Length', 'Length Of Stay in Intensive Care Unit (LOS ICU', 'injury severity for ISS', 'pneumonia', 'Of Stay (HLOS', 'duration of MV, LOS ICU and HLOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0272567', 'cui_str': 'Fracture of multiple ribs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0175008,"There were no significant statistic differences between patients of Group I and Group II in demographics, mechanism of injury, severity of trauma, and overall patient status.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dubrov', 'Affiliation': '1Bogomolets National Medical University, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Burianov', 'Affiliation': '1Bogomolets National Medical University, Kyiv, Ukraine.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lianskorunskyi', 'Affiliation': '1Bogomolets National Medical University, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miasnikov', 'Affiliation': '1Bogomolets National Medical University, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Tkalich', 'Affiliation': '2Shupyk National Medical Academy of Postgraduate Education, Kyiv; 3Kyiv City Clinical Hospital №17, Ukraine.'}]",Georgian medical news,[]
1248,32535564,COMPARISON OF POSTERIOR CAPSULE OPACIFICATION AFTER IMPLANTATION OF SAME DESIGN SINGLE-PIECE HYDROPHILIC AND HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES.,"The aim of the study was to determine the correlation between implanted IOL material type and posterior capsule opacification. At 12 month, there was no statistically and visually significant changes in all controlled groups. At 18 month, 3 eyes (5.2%) from Group 2 and 1 eye (5.8%) from hydrophobic arm of Group 3 had visually significant PCO and underwent Nd:YAG laser posterior capsulotomy. 8 eyes (10.8%) in group 1 and 3 eyes (17.6%) in hydrophilic arm of Group 3 required Nd:YAG laser posterior capsulotomy. At 3, 6, and 12 month compared to baseline (1 month postoperatively), there was no statistically and clinically significant difference in visual acuity and subjective refraction between the groups. At 12 month, 3 patients (4%) from group 1 and 1 patient (6%) from hydrophilic arm of group 3 complained of glare sensitivity, especially in mesopic conditions. At that point, interestingly, no patient from Group 2 and hydrophobic arm of Group 3 complained about glare sensitivity. In terms of UCDVA, 68 eyes of group 1 (91%) achieved 20/20 or better distance vision, 71 eyes (96%) achieved 20/25 distance vision. In Group 2, 50 eyes (87%) achieved 20/20 or better distance vision, 52 eyes (92%) achieved 20/25 distance vision. In Group 3, 14 eyes (82%) of hydrophilic arm achieved 20/20 or better distance vision and 15 eyes (88%) achieved 20/25 distance vision. In hydrophobic arm of group 3, 16 eyes (94%) achieved 20/20 or better distance vision. UCDVA was examined with ClearChart 2 Digital Acuity System (Reichert Technologies), using Landolt C optotypes. Biometry data was acquired by IOLMaster-500 (Carl Zeiss, Meditec). Contrast sensitivity was evaluated with ClearChart 2 Digital Acuity System (Reichert Technologies), using Pelli-Robson Contrast Sensitivity Chart. At 1, 3, 6, month there was no statistically significant difference between controlled groups in terms of contrast sensitivity. At 12 month, 5 patients (6%) from Group 1 and 3 patients (17%) from Group 3 hydrophilic arm had slightly decreased contrast sensitivity. There was no changes in contrast sensitivity in eyes of Group 2 at 12 month period. The study is still ongoing. The patients will be evaluated at 24 month and 36 month postoperatively.",2020,"At 1, 3, 6, month there was no statistically significant difference between controlled groups in terms of contrast sensitivity.",[],['UCDVA'],"['20/25 distance vision', 'visual acuity and subjective refraction', 'Contrast sensitivity', 'contrast sensitivity', 'distance vision', 'glare sensitivity']",[],[],"[{'cui': 'C1690939', 'cui_str': '20/25'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0278215', 'cui_str': 'Glare'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0489247,"At 1, 3, 6, month there was no statistically significant difference between controlled groups in terms of contrast sensitivity.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dvali', 'Affiliation': 'Tbilisi State Medical University, Department of Eye Disease; Eye clinic ""Akhali Mzera"", Tbilisi, Georgia.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tsertsvadze', 'Affiliation': 'Tbilisi State Medical University, Department of Eye Disease; Eye clinic ""Akhali Mzera"", Tbilisi, Georgia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mekvabishvili', 'Affiliation': 'Tbilisi State Medical University, Department of Eye Disease; Eye clinic ""Akhali Mzera"", Tbilisi, Georgia.'}]",Georgian medical news,[]
1249,32557872,"L-Carnitine metabolism, protein turnover and energy expenditure in supplemented and exercised Labrador Retrievers.","L-Carnitine is critical for protection against bioaccumulation, long-chain fatty acid transportation and energy production. Energy production becomes important as the body maintains lean mass, repairs muscles and recovers from oxidative stress. The aim was to investigate the effects of supplemented L-carnitine on protein turnover (PT), energy expenditure (EE) and carnitine metabolism in muscle/serum of Labrador Retrievers. In a series of experiments, all dogs were fed a low-carnitine diet and sorted into one of two groups: L-carnitine (LC) supplemented daily with 125 mg L-carnitine and 3.75 g sucrose or placebo (P) supplemented with 4 g sucrose daily. The experiments consisted of analyses of muscle/serum for L-carnitine content (EXP1), a protein turnover experiment (EXP2) and analysis of substrate utilization via indirect calorimetry (EXP3). EXP1: 20 Labradors (10 M/10 F) performed a 13 week running regimen. L-Carnitine content was analysed in the serum and biceps femoris muscle before/after a 24.1 km run. LC serum had higher total (p < .001; p = .001), free (p < .001; p = .001) and esterified (p = .001; p = .003) L-carnitine pre- and post-run respectively. LC muscle had significantly higher free L-carnitine post-run (p = .034). EXP2: 26 Labs (13 M/13 F) performed a 60-day running regimen. For the final run, half of the Labradors from each treatment rested and half ran 24.1 km. Twenty-four Labradors received isotope infusion, and then, a biopsy of the biceps femoris of all 26 Labradors was taken to determine PT. Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042). LC females had a lower FBR v. P females (p = .046). EXP3: Respiration of 16 Labradors (8 M/8 F) was measured via indirect calorimetry over 15 week. All dogs ran on a treadmill for 30 min at 30% VO 2  max (6.5 kph), resulting in higher maximum and mean EE in LC females v. P females (p = .021; p = .035). Implications for theory, practice and future research are discussed.",2020,Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042).,"['muscle/serum of Labrador Retrievers', '16 Labradors (8 M/8 F']","['supplemented L-carnitine', 'EXP3', 'muscle/serum for L-carnitine content (EXP1), a protein turnover experiment (EXP2) and analysis of substrate utilization via indirect calorimetry (EXP3', 'L-carnitine (LC) supplemented daily with 125\xa0mg L-carnitine and 3.75\xa0g sucrose or placebo (P) supplemented with 4\xa0g sucrose daily']","['protein turnover (PT), energy expenditure (EE) and carnitine metabolism', 'L-Carnitine metabolism, protein turnover and energy expenditure', 'fractional breakdown rate (FBR', 'L-Carnitine content']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0324431', 'cui_str': 'Labrador retriever'}, {'cui': 'C0022888', 'cui_str': 'Labrador'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",,0.0170811,Resting/exercised LC had a lower fractional breakdown rate (FBR) versus P group (p = .042).,"[{'ForeName': 'Jessica Lyn', 'Initials': 'JL', 'LastName': 'Varney', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}, {'ForeName': 'Jason William', 'Initials': 'JW', 'LastName': 'Fowler', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}, {'ForeName': 'Trenda Clarice', 'Initials': 'TC', 'LastName': 'McClaughry', 'Affiliation': 'ELIAS Animal Health LLC, Olathe, KS, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Vignale', 'Affiliation': 'Kemin Industries Inc., Des Moines, IA, USA.'}, {'ForeName': 'Justina', 'Initials': 'J', 'LastName': 'Caldas', 'Affiliation': 'Cobb-Vantress Inc., Siloam Springs, AR, USA.'}, {'ForeName': 'Jordan Taylor', 'Initials': 'JT', 'LastName': 'Weil', 'Affiliation': 'University of Arkansas, Fayetteville, AR, USA.'}, {'ForeName': 'Craig Nelson', 'Initials': 'CN', 'LastName': 'Coon', 'Affiliation': 'Four Rivers Kennel LLC, Walker, MO, USA.'}]",Journal of animal physiology and animal nutrition,['10.1111/jpn.13391']
1250,32552430,Differential changes in muscle architecture and neuromuscular fatigability induced by isometric resistance training at short and long muscle-tendon unit lengths.,"We evaluated the effects of differential muscle architectural adaptations on neuromuscular fatigue resistance. Seven young males and six females participated in this study. Using a longitudinal within-subject design, legs were randomly assigned to perform isometric training of the tibialis anterior (TA) three times per week for 8 wk at a short (S-group) or long muscle-tendon unit length (L-group). Before and following training, fascicle length (FL) and pennation angle (PA) of the TA were assessed. As well, fatigue-related time course changes in isometric maximal voluntary contraction (MVC) torque and isotonic peak power (20% MVC resistance) were determined before, immediately after, and 1, 2, 5, and 10 min following task failure. The fatiguing task consisted of repeated maximal effort isotonic (20% MVC resistance) contractions over a 40° range of motion until the participant reached a 40% reduction in peak power. Although there was no clear improvement in neuromuscular fatigue resistance following training in either group ( P  = 0.081; S-group: ∼20%; L-group: ∼51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (∼6%,  P  < 0.001) in the S-group ( r  = 0.739,  P  = 0.004) and negatively to the training-induced increase in FL (∼4%,  P  = 0.001) in the L-group ( r  = -0.568,  P  = 0.043). Both groups recovered similarly for MVC torque and peak power after the fatiguing task as compared with before training. We suggest that the relationships between the changes in muscle architecture and neuromuscular fatigue resistance depend on the muscle-tendon unit lengths at which the training is performed. NEW & NOTEWORTHY  Eight weeks of isometric training at a long or short muscle-tendon unit length increased and did not change fascicle length, respectively. The ""width"" of the torque-angle relationship plateau became broader following isometric training at the long length. Despite marked differences in muscle architecture and functional adaptations between the groups, there was only a small-magnitude improvement in neuromuscular fatigue resistance, which was surprisingly negatively related to increased fascicle length in the long length-training group.",2020,"Although there was no clear improvement of neuromuscular fatigue resistance following training in both groups (P = 0.081; S-Group: ~20%, L-Group: ~51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (~6%, P < 0.001) in the S-Group (r = 0.739, P = 0.004) and negatively to the training-induced increase in FL (~4%, P = 0.001) in the L-Group (r = -0.568, P = 0.043).",['Seven young males and 6 females participated in this study'],"['differential muscle architectural adaptations', 'isometric resistance training', 'isometric training of the tibialis anterior (TA', 'fatiguing task consisted of repeated maximal effort isotonic (20%MVC resistance) contractions']","['FL', 'PA', 'fascicle length (FL) and pennation angle (PA) of the TA', 'neuromuscular fatigue resistance', 'fatigue-related time-course changes in isometric maximal voluntary contraction (MVC) torque and isotonic peak power (20%MVC resistance', 'MVC torque and peak power']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",7.0,0.0211373,"Although there was no clear improvement of neuromuscular fatigue resistance following training in both groups (P = 0.081; S-Group: ~20%, L-Group: ~51%), the change in neuromuscular fatigue resistance was related positively to the training-induced increase in PA (~6%, P < 0.001) in the S-Group (r = 0.739, P = 0.004) and negatively to the training-induced increase in FL (~4%, P = 0.001) in the L-Group (r = -0.568, P = 0.043).","[{'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Akagi', 'Affiliation': 'College of Systems Engineering and Science, Shibaura Institute of Technology, Saitama, Japan.'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Hinks', 'Affiliation': 'Department of Human Health and Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Power', 'Affiliation': 'Department of Human Health and Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00280.2020']
1251,32553878,Impact of Platelet-rich Plasma in the Healing of Through-and-through Periapical Lesions Using 2-dimensional and 3-dimensional Evaluation: A Randomized Controlled Trial.,"INTRODUCTION


The purpose of this randomized controlled trial was to evaluate the role of platelet-rich plasma (PRP) in the healing of through-and-through periapical lesions using both 2-dimensional periapical radiographs and 3-dimensional (3D) cone-beam computed tomographic imaging.
METHODS


Thirty-four patients after confirmation of a through-and-through periapical lesion were enrolled and randomly assigned to either the control or PRP group. Periapical surgery was performed, and grafting of the bone defect with PRP was done in the PRP group before suturing. Follow-up was scheduled at 12 months for clinical and radiographic analysis based on Molven's criteria; modified Penn 3D criteria; and resected plane, apical area, and cortical plate indexes. The absolute area and volume of the lesions were measured preoperatively and at follow-up using CorelDRAW X7 (64-bit) (Corel Corporation, Ottawa, Canada) and ITK Snap software (free software under the GNU General Public License developed by the National Institutes of Health, the US National Institute of Biomedical Imaging and BioEngineering, the US National Library of Medicine, the Universities of Pennsylvania and North Carolina, and an independent developer group), respectively.
RESULTS


Thirty-two patients were available at follow-up. A success rate of 93.7% was observed for both the control and PRP groups on 2-dimensional evaluation, whereas the PRP group exhibited a significantly higher success rate (87.5%) than the control (50%) on 3D assessment. A significantly higher percentage reduction in the lesion volume was documented in the PRP group (92.30 ± 4.72) than the control group (83.04 ± 12.82). Resected plane, apical area, and cortical plate indexes revealed a significantly higher scoring at the resected plane and cortical plate parameter in the PRP group. Overall analysis documented the faster re-establishment of the palatal cortical plate than the buccal cortical plate in through-and-through lesions.
CONCLUSIONS


These results suggest that PRP improves the healing outcome in through-and-through lesions. CBCT imaging provides better healing assessment after periapical surgery over periapical radiographs in such lesions.",2020,A significantly higher percentage reduction in the lesion volume was documented in the PRP (92.30±4.72) group than the control (83.04±12.82).,"['34 patients after confirmation of through-and-through periapical lesion', '32 patients were available at follow up']","['platelet rich plasma (PRP', 'PRP', '2-dimensional (2D) periapical radiograph and 3-dimensional (3D) cone beam computed tomography (CBCT', 'CBCT', 'Platelet rich plasma', 'control or PRP']","['absolute area and volume of the lesions', 'lesion volume', 'success rate', 'healing outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",32.0,0.0684005,A significantly higher percentage reduction in the lesion volume was documented in the PRP (92.30±4.72) group than the control (83.04±12.82).,"[{'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Dhamija', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Tewari', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India. Electronic address: tewarisanjayrohtak@yahoo.co.in.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sangwan', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Jigyasa', 'Initials': 'J', 'LastName': 'Duhan', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana, India.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.004']
1252,32559272,Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial.,"BACKGROUND


Inverse associations have been reported between serum 25-hydroxyvitamin D [25(OH)D] and circulating cholesterol concentrations in observational studies. Postulated mechanisms include reduced bioavailability of intestinal cholesterol and alterations in endogenous cholesterol synthesis.
OBJECTIVE


To explore the effect of daily supplementation with 4000 IU/d vitamin D3 for 24 wk on surrogate biomarkers of cholesterol absorption (campesterol and β-sitosterol) and endogenous synthesis (lathosterol and desmosterol).
METHODS


Ancillary study of The Vitamin D for Established Type 2 Diabetes (DDM2) trial. Patients with established type 2 diabetes (N = 127, 25-75 y, BMI 23-42 kg/m2) were randomly assigned to receive either 4000 IU vitamin D3 or placebo daily for 24 wk. Of participants without changes in cholesterol-lowering medications (n = 114), plasma surrogate cholesterol absorption and endogenous synthesis biomarker concentrations were measured and merged with available measures of serum LDL cholesterol and HDL cholesterol concentrations.
RESULTS


At week 24, vitamin D3 supplementation significantly increased 25(OH)D concentrations (+21.5 ± 13.4 ng/mL) but not insulin secretion rates (primary outcome of the parent study) as reported previously. In this ancillary study there was no significant effect of vitamin D3 supplementation on serum cholesterol profile or surrogate biomarkers of cholesterol absorption and endogenous synthesis. Compared with participants not treated with cholesterol-lowering medications, those who were treated exhibited a greater reduction in plasma campesterol concentrations in the vitamin D3 but not placebo group (P-interaction = 0.011). Analyzing the data on the basis of cholesterol absorption status (hypo- versus hyperabsorbers) or cholesterol synthesis status (hypo- versus hypersynthesizers) did not alter these results.
CONCLUSIONS


Vitamin D3 supplementation for 24 wk had no significant effect on surrogate biomarkers of cholesterol absorption or endogenous synthesis, consistent with the lack of effect on serum cholesterol profile. Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications. Further studies are required.This trial was registered at clinicaltrials.gov as NCT01736865.",2020,Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications.,"['Patients with established type 2 diabetes (N\xa0=\xa0127, 25-75 y, BMI 23-42 kg/m2', 'Established Type 2 Diabetes (DDM2) trial', 'patients with type 2 diabetes']","['Vitamin D', '4000 IU vitamin D3 or placebo', 'daily supplementation with 4000 IU/d vitamin D3', 'vitamin D3 supplementation', 'Vitamin D3 supplementation', 'placebo']","['25(OH)D concentrations', 'serum cholesterol profile or surrogate biomarkers of cholesterol absorption and endogenous synthesis', 'insulin secretion rates', 'serum LDL cholesterol and HDL cholesterol concentrations', 'serum 25-hydroxyvitamin D [25(OH)D] and circulating cholesterol concentrations', 'cholesterol-lowering medications', 'plasma campesterol concentrations', 'plasma surrogate cholesterol absorption and endogenous synthesis biomarker concentrations', 'campesterol concentrations', 'serum cholesterol profile', 'cholesterol absorption (campesterol and β-sitosterol) and endogenous synthesis (lathosterol and desmosterol', 'cholesterol absorption and endogenous synthesis', 'surrogate biomarkers of cholesterol absorption or endogenous synthesis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054560', 'cui_str': 'campesterol'}, {'cui': 'C0037215', 'cui_str': 'Sitosterols'}, {'cui': 'C0064673', 'cui_str': 'Lathosterol'}, {'cui': 'C0011704', 'cui_str': '24-Dehydrocholesterol'}]",,0.270391,Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications.,"[{'ForeName': 'Huicui', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Angellotti', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa149']
1253,32560576,"Erratum: Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial;  Nutrients  2020,  12 , 1165.",The authors would like to correct an error in a recent published paper [...].,2020,The authors would like to correct an error in a recent published paper [...].,['Pregnant Women with Gestational Diabetes'],['Erratum: Dietary Intervention'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]",[],,0.178666,The authors would like to correct an error in a recent published paper [...].,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Kusinski', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': 'Cambridge Universities NHS Foundation Trust, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Emanuella De Lucia', 'Initials': 'EL', 'LastName': 'Rolfe', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Rennie', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Linda M Oude', 'Initials': 'LMO', 'LastName': 'Griep', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre - Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Cellular Medicine, University of Newcastle, NE4 5PL, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': 'Institute of Metabolic Science, University of Cambridge, CB2 0QQ, UK.'}]",Nutrients,['10.3390/nu12061793']
1254,32562376,"Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal-bolus insulin therapy: An open label, prospective, multicenter trial in Japan.","AIMS/INTRODUCTION


We investigated the effect of FreeStyle Libre TM  on glycemic control in Japanese type 2 diabetes patients treated with basal-bolus insulin therapy.
MATERIALS AND METHODS


This prospective, 90-day single-arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14-day masked baseline phase was followed by an 11-week treatment phase during which participants used the device to monitor glucose levels. The primary end-point was time spent in hypoglycemia (<70 mg/dL) for baseline versus study end (days 76-90). Secondary end-points included other measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire.
RESULTS


Time spent in hypoglycemia was low at baseline (0.51 ± 0.93 h/day) and did not significantly decrease at study end (0.47 ± 0.63 h/day, P = 0.6354). Time in range, time in hyperglycemia and estimated A1c all improved versus baseline (by +1.7 ± 3.0 h/day, -1.6 ± .4 h/day and -0.4 ± 0.8%, respectively, P < 0.0001 in each). Finger stick tests fell from 2.9 ± 1.3 to 1.9 ± 1.4/day, and mean scanning frequency during the intervention phase was 11.3/day. The mean treatment satisfaction score increased by 11.8 ± 5.3 (P < 0.0001). Two severe hypoglycemia-related adverse events were reported; one of which was possibly related to the device. Three participants reported mild device-related skin trauma, site discomfort or subcutaneous bleeding.
CONCLUSIONS


Use of FreeStyle Libre by Japanese type 2 patients diabetes treated with basal-bolus insulin therapy showed a low baseline of hypoglycemia, and enabled improved glycemic control and treatment satisfaction.",2020,Mean treatment satisfaction score increased by 11.8 ± 5.3 (p<0.0001).,"['Japanese type 2 diabetes subjects treated with basal-bolus insulin therapy', '94 adults with type 2 diabetes treated with insulin', 'Subjects with Type 2 Diabetes Treated with Basal-Bolus Insulin Therapy']","['FreeStyle Libre TM', 'FreeStyle Libre TM  Flash Glucose Monitoring System', 'FreeStyle Libre']","['severe hypoglycemia-related adverse events', 'measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire (DTSQ', 'mean scanning frequency', 'glycemic control and treatment satisfaction', 'mild device-related skin trauma, site discomfort or subcutaneous bleeding', 'Time spent in hypoglycemia', 'Mean treatment satisfaction score', 'Time in range, time in hyperglycemia', 'glycemic control', 'time spent in hypoglycemia']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2750515', 'cui_str': 'Subcutaneous bleeding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",94.0,0.0575329,Mean treatment satisfaction score increased by 11.8 ± 5.3 (p<0.0001).,"[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ogawa', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Nakakinen Clinic, Ibaraki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tosaki', 'Affiliation': 'TDE Healthcare Corporation, TOSAKI Clinic for Diabetes and Endocrinology, Aichi, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Utsunomiya', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Rimei', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13327']
1255,32566597,"Erratum to efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial.",[This corrects the article DOI: 10.21037/atm.2019.07.95.].,2020,[This corrects the article DOI: 10.21037/atm.2019.07.95.].,['patients with breast cancer'],"['mecapegfilgrastim', 'chemotherapy-induced neutropenia']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3179328', 'cui_str': 'pegylated granulocyte colony-stimulating factor'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}]",[],,0.0210156,[This corrects the article DOI: 10.21037/atm.2019.07.95.].,"[{'ForeName': 'Fengrui', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Breast Surgery, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Zhanhui', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Xinxiang University, Xinxiang 453100, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Breast Surgery, Hongqing Cancer Hospital, Chongqing 400030, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, Sichuan Province People's Hospital, Chengdu 610072, China.""}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Zhongshan University Cancer Center, Guangzhou 510060, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Breast Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.'}, {'ForeName': 'Zhiyue', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Research and Development, Jiangsu Hengrui Medicine Co., Ltd., Shanghai 200120, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Research and Development, Jiangsu Hengrui Medicine Co., Ltd., Shanghai 200120, China.'}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China.'}]",Annals of translational medicine,['10.21037/atm-2020-23']
1256,32563378,"Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.","BACKGROUND


Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding.
METHODS


We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.
FINDINGS


Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).
INTERPRETATION


We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"['patients with gastrointestinal bleeding', 'Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding', 'patients with trauma', '164 hospitals in 15 countries', 'patients with acute gastrointestinal bleeding (HALT-IT', 'Between July 4, 2013, and June 21, 2019, we randomly allocated 12\u2008009 patients to receive']","['Tranexamic acid', 'placebo', 'matching placebo', 'tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9', 'tranexamic acid', '0·9% sodium chloride']","['death due to bleeding', 'death and thromboembolic events', 'Venous thromboembolic events (deep vein thrombosis or pulmonary embolism', 'Arterial thromboembolic events (myocardial infarction or stroke', 'Death due to bleeding', 'death from gastrointestinal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0024050', 'cui_str': 'Lower gastrointestinal hemorrhage'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0266807', 'cui_str': 'Acute gastrointestinal hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0104485', 'cui_str': 'AT 125'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",12009.0,0.734066,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30848-5']
1257,32564804,An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care.,"INTRODUCTION


The use of screening can prevent death from colorectal cancer, yet people without regular healthcare visits may not realize the benefits of this preventive intervention. The objective of this study was to determine the effectiveness of a mailed screening invitation or mailed fecal immunochemical test in increasing colorectal cancer screening uptake in veterans without recent primary care encounters.
STUDY DESIGN


Three-arm pragmatic randomized trial.
SETTING/PARTICIPANTS


Participants were screening-eligible veterans aged 50-75 years, without a recent primary care visit who accessed medical services at the Corporal Michael J. Crescenz Veteran Affairs Medical Center between January 1, 2017, and July 31, 2017. All data were analyzed from March 1, 2018, to July 31, 2018.
INTERVENTION


Participants were randomized to (1) usual opportunistic screening during a healthcare visit (n=260), (2) mailed invitation to screen and reminder phone calls (n=261), or (3) mailed fecal immunochemical test outreach plus reminder calls (n=61).
MAIN OUTCOME MEASURES


The main outcome under investigation was the completion of colorectal cancer screening within 6 months after randomization.
RESULTS


Of 782 participants in the trial, 53.9% were aged 60-75 years and 59.7% were African American. The screening rate was higher in the mailed fecal immunochemical test group (26.1%) compared with usual care (5.8%) (rate difference=20.3%, 95% CI=14.3%, 26.3%; RR=4.52, 95% CI=2.7, 7.7) or screening invitation (7.7%) (rate difference=18.4%, 95% CI=12.2%, 24.6%; RR=3.4, 95% CI=2.1, 5.4). Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5).
CONCLUSIONS


Mailed fecal immunochemical test screening promotes colorectal cancer screening participation among veterans without a recent primary care encounter. Despite the addition of reminder calls, an invitation letter was no more effective in screening participation than screening during outpatient appointments.
TRIAL REGISTRATION


This study is registered at clinicaltrials.gov NCT02584998.",2020,"Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5).
","['782 participants in the trial, 53.9% were aged 60-75 years and 59.7% were African American', 'Veterans Without Recent Primary Care', 'Participants were screening-eligible veterans aged 50-75 years, without a recent primary care visit who accessed medical services at the Corporal Michael J. Crescenz Veteran Affairs Medical Center between January 1, 2017, and July 31, 2017', 'veterans without a recent primary care encounter', 'veterans without recent primary care encounters']","['usual opportunistic screening during a healthcare visit (n=260), (2) mailed invitation to screen and reminder phone calls (n=261), or (3) mailed fecal immunochemical test outreach plus reminder calls (n=61', 'mailed screening invitation or mailed fecal immunochemical test']","['screening invitation', 'Screening completion rates', 'completion of colorectal cancer screening', 'screening rate']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0422389', 'cui_str': 'Opportunistic screening'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",,0.289727,"Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5).
","[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Goldshore', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: matthew.goldshore@pennmedicine.upenn.edu.'}, {'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Woodrow', 'Initials': 'W', 'LastName': 'Fletcher', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Center for Health Equity and Community Engagement Research, Mayo Clinic, Rochester, Minnesota; Department of Family Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'E Carter', 'Initials': 'EC', 'LastName': 'Paulson', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.014']
1258,32564889,"Erratum to ""Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer - Results of the international randomized RAPIDO-trial"" [Radiother. Oncol. 147 (2020) 75-83].",,2020,,"['147', 'high-risk rectal cancer ']","['preoperative chemotherapy and surgery', 'short-course radiotherapy']",[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.036791,,"[{'ForeName': 'Maxime J M', 'Initials': 'MJM', 'LastName': 'van der Valk', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: mvandervalk@lumc.nl.'}, {'ForeName': 'Corrie A M', 'Initials': 'CAM', 'LastName': 'Marijnen', 'Affiliation': 'Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands; Department of Radiotherapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Esmée A', 'Initials': 'EA', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Medical Oncology, University of Groningen, The Netherlands.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Hilling', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Elma', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Annet G H', 'Initials': 'AGH', 'LastName': 'Roodvoets', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Renu R', 'Initials': 'RR', 'LastName': 'Bahadoer', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Fokstuen', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Jan Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': 'Department of Medical Oncology, Vall Hebron University Hospital, Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain.'}, {'ForeName': 'Mathijs P', 'Initials': 'MP', 'LastName': 'Hendriks', 'Affiliation': 'Department of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Edhemovic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology Ljubljana, Slovenia.'}, {'ForeName': 'Andrès M R', 'Initials': 'AMR', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Spain.'}, {'ForeName': 'Derk Jan A', 'Initials': 'DJA', 'LastName': 'de Groot', 'Affiliation': 'Department of Medical Oncology, University of Groningen, The Netherlands.'}, {'ForeName': 'Per J', 'Initials': 'PJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Geke A P', 'Initials': 'GAP', 'LastName': 'Hospers', 'Affiliation': 'Department of Medical Oncology, University of Groningen, The Netherlands. Electronic address: g.a.p.hospers@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.006']
1259,32466836,Use of the Win Ratio in Cardiovascular Trials.,"OBJECTIVES


The purpose of this study was to compare the win ratio (WR) with the corresponding hazard ratios (HRs) and 1/HR.
BACKGROUND


The primary outcome in many cardiovascular trials is a composite that includes nonfatal and fatal events. The time-to-first event analysis gives equal statistical weighting to each component event. The WR, which takes into account the clinical importance and timing of the outcomes, has been suggested as an alternative approach.
METHODS


Cox proportional hazards models and WR.
RESULTS


In the these trials (n = 16) the WR and HR differed only slightly. For example, in the PARADIGM-HF (sacubitril/valsartan vs. enalapril), the primary outcome of time to first heart failure hospitalization (HFH) or cardiovascular death (CVD) and use of the Cox model gave a 1/HR of 1.25 (95% confidence interval [CI]: 1.12 to 1. 41; z-score = 4.8). Using WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.27 (95% CI: 1.15 to 1.39; z-score = 4.7), reflecting an effect similar to that of sacubitril/valsartan therapy on CVD and HFH. In the DIG (digoxin vs. placebo) trial, the outcome of time-to-first HFH or CVD using Cox gave a 1/HR of 1.18 (95% CI: 1.10 to 1.27; z-score = 4.5). Using the WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.14 (95% CI: 1.05 to 1.20; z-score = 3.1), reflecting a larger effect of digoxin on HFH than on CVD. Several other trials and endpoints including patient-reported measurements were studied.
CONCLUSIONS


In 16 large cardiovascular outcome trials, HR and WR provided similar estimates of treatment effects. The WR allows prioritization of fatal outcomes and the hierarchical testing of broader composite endpoints including patient-reported outcomes. In this way, the WR allows for the incorporation of patient-centered and other outcomes, while prioritizing the competing risk of death and hospital admission.",2020,"Using the WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.14 (95% CI: 1.05 to 1.20; z-score = 3.1), reflecting a larger effect of digoxin on HFH than on CVD.",[],"['valsartan vs. enalapril', 'DIG (digoxin vs. placebo', 'digoxin']","['win ratio (WR) with the corresponding hazard ratios (HRs) and 1/HR', 'time to first heart failure hospitalization (HFH) or cardiovascular death (CVD', 'nonfatal and fatal events']",[],"[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C1321878', 'cui_str': 'Desmoplastic infantile ganglioglioma'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.173785,"Using the WR for testing this composite in the hierarchical order of CVD and HFH gave a WR of 1.14 (95% CI: 1.05 to 1.20; z-score = 3.1), reflecting a larger effect of digoxin on HFH than on CVD.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Duarte', 'Affiliation': 'National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""National Institute of Health and Medical Research, Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France; Cardiovascular Division, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.02.010']
1260,31811487,Correction to: Efficacy of a medication management service in improving adherence to tyrosine kinase inhibitors and clinical outcomes of patients with chronic myeloid leukaemia: a randomised controlled trial.,Revised Funding Information.,2020,Revised Funding Information.,['patients with chronic myeloid leukaemia'],['medication management service'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}]","[{'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],,0.0806075,Revised Funding Information.,"[{'ForeName': 'Bee Kim', 'Initials': 'BK', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siew Siang', 'Initials': 'SS', 'LastName': 'Chua', 'Affiliation': ""School of Pharmacy, Faculty of Health and Medical Sciences, Taylor's University, 47500, Subang Jaya, Selangor, Malaysia.""}, {'ForeName': 'Li-Chia', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}, {'ForeName': 'Kian Meng', 'Initials': 'KM', 'LastName': 'Chang', 'Affiliation': 'Department of Hematology, Ampang Hospital, 68000, Ampang, Selangor, Malaysia.'}, {'ForeName': 'Sharmini', 'Initials': 'S', 'LastName': 'Balashanker', 'Affiliation': 'School of Pharmacy, University of Nottingham Malaysia Campus, 43500, Semenyih, Selangor, Malaysia.'}, {'ForeName': 'Ping Chong', 'Initials': 'PC', 'LastName': 'Bee', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603, Kuala Lumpur, Malaysia. pcbee@um.edu.my.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05212-2']
1261,32472804,Goal-directed versus Standard Fluid Therapy to Decrease Ileus after Open Radical Cystectomy: A Prospective Randomized Controlled Trial.,"BACKGROUND


Postoperative ileus is a common complication of intraabdominal surgeries, including radical cystectomy with reported rates as high as 32%. Perioperative fluid administration has been associated with improvement in postoperative ileus rates, but it is difficult to generalize because earlier studies lacked standardized definitions of postoperative ileus and other relevant outcomes. The hypothesis was that targeted individualized perioperative fluid management would improve postoperative ileus in patients receiving radical cystectomy.
METHODS


This is a parallel-arm, double-blinded, single-center randomized trial of goal-directed fluid therapy versus standard fluid therapy for patients undergoing open radical cystectomy. The primary outcome was postoperative ileus, and the secondary outcome was complications within 30 days post-surgery. Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation. The intervention in the goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring.
RESULTS


Between August 2014 and April 2018, 283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy) were included in the analysis. Postoperative ileus occurred in 25% (36 of 142) of patients in the goal-directed fluid therapy arm and 21% (30 of 141) of patients in the standard arm (difference in proportions, 4.1%; 95% CI, -5.8 to 13.9; P = 0.418). There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
CONCLUSIONS


Goal-directed fluid therapy may not be an effective strategy for lowering the risk of postoperative ileus in patients undergoing open radical cystectomy.",2020,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","['patients undergoing open radical cystectomy', '283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy', 'patients having radical cystectomy', 'patients receiving radical cystectomy', 'Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation', 'Between August 2014 and April 2018']","['fluid therapy versus standard fluid therapy', 'intraoperative fluid therapy over standard fluid therapy', 'Standard Fluid Therapy', 'Open Radical Cystectomy', 'goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring']","['incidence of high-grade complications', 'postoperative ileus', 'Postoperative ileus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}]",,0.569234,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","[{'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Anesthesiology Service (V.A.-C., A.C.P., M.F.) the Department of Epidemiology and Biostatistics (K.S.T.) the Department of Surgery, Urology Service (G.D., H.W.H., B.H.B., E.K.C., T.F.D., S.M.D.), Memorial Sloan Kettering Cancer Center, New York, New York the Departments of Urology (G.D., H.W.H., B.H.B., E.K.C., S.M.D.) Anesthesiology (A.C.P., M.F.), Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Kay See', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': ''}, {'ForeName': 'Alessia C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': ''}, {'ForeName': 'Harry W', 'Initials': 'HW', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Bernard H', 'Initials': 'BH', 'LastName': 'Bochner', 'Affiliation': ''}, {'ForeName': 'Eugene K', 'Initials': 'EK', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Donahue', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'S Machele', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003367']
1262,32470486,"Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.","BACKGROUND


Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation.
OBJECTIVE


This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019.
METHODS


We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019.
RESULTS


Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus standard-of-care treatment (22 patients) or placebo based on standard-of-care treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study. Treatment with ruxolitinib plus standard-of-care was not associated with significantly accelerated clinical improvement in severe patients with coronavirus disease 2019, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed computed tomography improvement at day 14 compared with 13 (61.9%) patients from the control group (P = .0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at day 28; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group.
CONCLUSIONS


Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest computed tomography improvement, a faster recovery from lymphopenia, and favorable side-effect profile in the ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.",2020,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","['severe coronavirus disease 2019 (COVID-19', 'patients with severe COVID-19', 'Forty-three patients']","['ruxolitinib plus SoC', 'placebo based on SoC treatment', 'ruxolitinib plus SoC treatment']","['tolerated with low toxicities and no new safety signals', 'overall mortality', 'died of respiratory failure', 'CT improvement', 'Levels of 7 cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",43.0,0.116984,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Tiebin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Gaoxiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fankai', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jungang', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Divisions of Pathology and Experimental Hematology and Cancer Biology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: Gang.Huang@cchmc.org.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: wwang@vip.126.com.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: jfzhou@tjh.tjmu.edu.cn.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.019']
1263,32542356,SWEAT2 Study: Effectiveness of Trunk Training on Gait and Trunk Kinematics After Stroke: A Randomized Controlled Trial.,"OBJECTIVE


Trunk training after stroke is an effective method for improving mobility, yet underlying associations leading to the observed mobility carryover effects are unknown. The purposes of this study were to investigate the effectiveness of trunk training for gait and trunk kinematics and to find explanatory variables for the mobility carryover effects.
METHODS


This study was an assessor-masked, randomized controlled trial. Participants received either additional trunk training (n = 19) or cognitive training (n = 20) after subacute stroke. Outcome measures were the Tinetti Performance-Oriented Mobility Assessment (POMA), the Trunk Impairment Scale, spatiotemporal gait parameters, center-of-mass excursions, and trunk and lower limb kinematics during walking. Multivariate analysis with post hoc analysis was performed to observe treatment effects. Correlation and an exploratory regression analysis were used to examine associations with the mobility carryover effects.
RESULTS


Significant improvements after trunk training, compared with the findings for the control group, were found for the Trunk Impairment Scale, Tinetti POMA, walking speed, step length, step width, horizontal/vertical center-of-mass excursions, and trunk kinematics. No significant differences were observed in lower limb kinematics. Anteroposterior excursions of the trunk were associated with 30% of the variability in the mobility carryover effects.
CONCLUSIONS


Carryover effects of trunk control were present during ambulation. Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale. However, the implementation and generalizability of this treatment approach in a clinical setting are laborious and limited, necessitating further research.
IMPACT


Trunk training is an effective strategy for improving mobility after stroke. Regaining trunk control should be considered an important treatment goal early after stroke to adequately prepare patients for walking.",2020,Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale.,[],"['Trunk Training', 'trunk training', 'SWEAT2', 'IMPACT\n\n\nTrunk training', 'additional trunk training (n\xa0=\xa019) or cognitive training']","['Trunk Impairment Scale, Tinetti POMA, walking speed, step length, step width, horizontal/vertical center-of-mass excursions, and trunk kinematics', 'lower limb kinematics', 'Tinetti POMA Gait subscale', 'Gait and Trunk Kinematics', 'Tinetti Performance-Oriented Mobility Assessment (POMA), the Trunk Impairment Scale, spatiotemporal gait parameters, center-of-mass excursions, and trunk and lower limb kinematics during walking']",[],"[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0333277,Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale.,"[{'ForeName': 'Tamaya', 'Initials': 'T', 'LastName': 'Van Criekinge', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI, Universiteitsplein 1, Wilrijk, 2610 Belgium; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hallemans', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Herssens', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lafosse', 'Affiliation': 'RevArte Rehabilitation Hospital, Edegem, Antwerp, Belgium; and Department of Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Claes', 'Affiliation': 'RevArte Rehabilitation Hospital.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Truijen', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Saeys', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; RevArte Rehabilitation Hospital; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}]",Physical therapy,['10.1093/ptj/pzaa110']
1264,32536366,A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders.,"STUDY OBJECTIVES


This study aimed to evaluate the effect of weighted chain blankets on insomnia and sleep-related daytime symptoms for patients with major depressive disorder, bipolar disorder, generalized anxiety disorder, and attention deficit hyperactivity disorder.
METHODS


One hundred twenty patients were randomized (1:1) to either a weighted metal chain blanket or a light plastic chain blanket for 4 weeks. The outcome was evaluated using the Insomnia Severity Index as primary outcome measure and day and night diaries, Fatigue Symptom Inventory, and Hospital Anxiety and Depression Scale as secondary outcome measures. Sleep and daytime activity levels were evaluated by wrist actigraphy.
RESULTS


At 4 weeks, there was a significant advantage in Insomnia Severity Index ratings of the weighted blanket intervention over the light blanket (P < .001) with a large effect size (Cohen's d 1.90). The intervention by the weighted blanket resulted in a significantly better sleep-maintenance, a higher daytime activity level, and reduced daytime symptoms of fatigue, depression, and anxiety. No serious adverse events occurred. During a 12-month open follow-up phase of the study, participants continuing to use weighted blankets maintained the effect on sleep, while patients switching from a light to a weighted blanket experienced an effect on Insomnia Severity Index ratings similar to that of participants using the weighted blanket from the beginning.
CONCLUSIONS


Weighted chain blankets are an effective and safe intervention for insomnia in patients with major depressive disorder, bipolar disorder, generalized anxiety disorder, or attention deficit hyperactivity disorder, also improving daytime symptoms and levels of activity.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Controlled Study of Chain Blanket for Insomnia; URL: https://clinicaltrials.gov/ct2/show/NCT03546036; Identifier: NCT03546036.",2020,"At four weeks, there was a significant advantage in ISI-ratings of the weighted blanket intervention over the light blanket (p<0.001) with a large effect size (Cohen´s d 1.90).","['insomnia in psychiatric disorders', 'patients with major depressive disorder, bipolar disorder, generalized anxiety disorder (GAD) and attention deficit hyperactivity disorder (ADHD', 'One hundred twenty patients']","['weighted chain blankets', 'weighted metal chain blanket or a light plastic chain blanket']","['sleep-maintenance', 'daytime activity level and reduced daytime symptoms of fatigue, depression and anxiety', 'Sleep and daytime activity levels', 'Insomnia Severity Index (ISI) as primary outcome measure and the Day and Night Diaries (DND), Fatigue Symptom Inventory (FSI), and Hospital Anxiety and Depression Scale (HADS', 'insomnia and sleep-related daytime symptoms', 'ISI-ratings']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",120.0,0.0823028,"At four weeks, there was a significant advantage in ISI-ratings of the weighted blanket intervention over the light blanket (p<0.001) with a large effect size (Cohen´s d 1.90).","[{'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Ekholm', 'Affiliation': 'The Affective Disorder Outpatient Clinic at Psychiatry Southwest, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Spulber', 'Affiliation': 'Department of Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Adler', 'Affiliation': 'The Affective Disorder Outpatient Clinic at Psychiatry Southwest, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8636']
1265,32548907,Examining associative conditioning with a positive peer context as a strategy to increase children's vegetable acceptance.,"BACKGROUND


Children's vegetable acceptance increases following repeated exposure and associative conditioning pairing a target vegetable with a well-liked food. Yet traditional pairings may increase energy intake when well-liked foods are calorie-rich.
OBJECTIVES


To examine whether pairing a non-food stimulus with target vegetables increases children's vegetable acceptance and whether effects exceed those of repeated exposure.
METHODS


Twenty-three 6-to-8-year-old children participated in twice-weekly sessions across 6 weeks of a summer camp serving children from low-income families. First- and second-grade camp classrooms were randomly assigned to associative conditioning and repeated exposure groups, respectively. Liking and preference were assessed for seven vegetables at pre/post-test. For each child, two non-preferred vegetables were randomly assigned as the target or control. During exposures, associative conditioning group children experienced a positive peer context (involving group games) paired with tasting their target vegetable. The repeated exposure group received only taste exposures; target vegetable liking was assessed.
RESULTS


Preferences for target vegetables increased from pre- (Median = 6.00) to post-test (Median = 3.00) overall (P = .007), but did not differ by group (P = .59). Group, time and interaction effects on vegetable liking were non-significant overall (P ≥ .29), with some evidence of group differences when examining select time points.
CONCLUSIONS


Findings can inform future research aiming to increase vegetable preferences in community settings.",2020,"Group, time and interaction effects on vegetable liking were non-significant overall (P ≥ .29), with some evidence of group differences when examining select time points.
","['First- and second-grade camp classrooms', '6-to-8-year-old children', 'Twenty-three', 'For each child, two non-preferred vegetables']","['associative conditioning group children experienced a positive peer context (involving group games) paired with tasting their target vegetable', 'repeated exposure group received only taste exposures; target vegetable liking was assessed']","['time and interaction effects on vegetable liking', 'Liking and preference']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",,0.0967871,"Group, time and interaction effects on vegetable liking were non-significant overall (P ≥ .29), with some evidence of group differences when examining select time points.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tauriello', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bowker', 'Affiliation': 'Department of Psychology, College of Arts and Sciences, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, School of Public Health and Health Professions, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Anzman-Frasca', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.'}]",Pediatric obesity,['10.1111/ijpo.12660']
1266,32550640,Correction to: Adjusted tight control blood glucose management in diabetic patients undergoing on pump coronary artery bypass graft. A randomized clinical trial.,[This corrects the article DOI: 10.1007/s40200-020-00494-4.].,2020,[This corrects the article DOI: 10.1007/s40200-020-00494-4.].,['diabetic patients undergoing on pump coronary artery bypass graft'],['Correction to: Adjusted tight control blood glucose management'],[],"[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1638311', 'cui_str': 'Blood glucose management'}]",[],,0.0418528,[This corrects the article DOI: 10.1007/s40200-020-00494-4.].,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforoosh Zadeh', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Azemati', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00500-9']
1267,32557384,The Influence of Laparoscopic Sleeve Gastrectomy on Body Composition and Fat Distribution in Obese Caucasian Men and Women.,"BACKGROUND


The aim of the study was to assess changes in body composition in patients subjected to laparoscopic sleeve gastrectomy (LSG).
METHODS


Changes in body composition following LSG were determined in a group of 155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA). Whole body fat mass (FM) and lean body mass (LBM) were determined, and abdominal fat mass (AbdF) was assessed within the region extending from the top of the pubic bone up to the line between 12th thoracic and 1st lumbar vertebras.
RESULTS


Over the period of 12 months following LSG, body mass index decreased by 28.2 ± 9.0% (p < 0.001). The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001). AbdF decreased from 13.2 ± 3.1 to 8.2 ± 2.7 kg (p < 0.001), but abdominal fat to total fat mass ratio increased from 24.9 ± 4.7 to 28.0 ± 5.8% (p < 0.001). The loss of AbdF was more pronounced in men than in women. The rate of FM loss was attenuated with patients' age.
CONCLUSIONS


Over the period of 12 months following LSG, the reduction of FM was more than twice as much as decrease of LBM. The loss of AbdF was slower than a loss of peripheral subcutaneous fat.",2020,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"['patients subjected to', '155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA', 'Obese Caucasian Men and Women']","['Laparoscopic Sleeve Gastrectomy', 'laparoscopic sleeve gastrectomy (LSG']","['rate of FM loss', 'FM', 'body mass index', 'reduction of body weight', 'body composition', 'abdominal fat to total fat mass ratio', 'LBM', 'loss of AbdF', 'Body Composition and Fat Distribution', 'Whole body fat mass (FM) and lean body mass (LBM', 'reduction of FM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",155.0,0.0416692,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Tałałaj', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland. marektalalaj@op.pl.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Bogołowska-Stieblich', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wąsowski', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Binda', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Jaworski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wrzosek', 'Affiliation': 'Department of Biochemistry and Pharmacogenomics, Faculty of Pharmacy, Medical University of Warsaw, Banacha 1, 02-097, Warsaw, Poland.'}, {'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Tarnowski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}]",Obesity surgery,['10.1007/s11695-020-04766-z']
1268,32553151,"Novel antisense inhibition of diacylglycerol O-acyltransferase 2 for treatment of non-alcoholic fatty liver disease: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial.","BACKGROUND


Diacylglycerol-O-acyltransferase 2 (DGAT2) is one of two enzyme isoforms that catalyse the final step in the synthesis of triglycerides. IONIS-DGAT2 Rx  is an antisense oligonucleotide inhibitor of DGAT2 that is under clinical investigation for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The aim of this trial was to examine the safety, tolerability, and efficacy of IONIS-DGAT2 Rx  versus placebo in reducing liver fat in patients with type 2 diabetes and NAFLD.
METHODS


This double-blind, randomised, placebo-controlled, phase 2 study consisted of a 2-week screening period, a run-in period of up to 4 weeks, a 13-week treatment period of once-weekly dosing, and a 13-week post-treatment follow-up period. The study was done at 16 clinical research sites in Canada, Poland, and Hungary. Eligible participants were aged 18-75 years, had a body-mass index at screening between 27 kg/m 2  and 39 kg/m 2 , haemoglobin A 1c  (HbA 1c ) levels from 7·3% to 9·5%, and liver fat content 10% or greater before randomisation, and agreed to maintain a stable diet and exercise routine throughout the study. Enrolled participants were stratified on the basis of liver fat content during the run-in period (<20% or ≥20%) and then centrally randomised (2:1) to receive once weekly subcutaneous injection of 250 mg IONIS-DGAT2 Rx  or placebo for 13 weeks. Participants, investigators, funder personnel, and the clinical research organisation staff, including central readers of MRI scans, were all masked to treatment identity. The primary endpoints were the safety, tolerability, and pharmacodynamic effect of IONIS-DGAT2 Rx  on hepatic steatosis, according to absolute reduction from baseline in liver fat percentage as quantified by MRI-estimated proton density fat fraction and assessed in the per-protocol population. Pharmacodynamic performance was determined in the per-protocol population by the change in liver fat content from baseline to 2 weeks after the last dose. The per-protocol population included all randomised participants who received at least ten doses of study drug, with the first four doses administered in the first 5 weeks, did not miss more than three consecutive weekly doses, and who had no protocol deviations that might affect efficacy. All randomised participants who received at least one dose of study drug were included in the safety analysis. This study is registered with ClinicalTrials.gov, NCT03334214.
FINDINGS


Between Nov 3, 2017, and Nov 28, 2018, we screened 173 people for eligibility. 44 were enrolled and randomly assigned to receive either IONIS-DGAT2 Rx  (29 participants) or placebo (15 participants). After 13 weeks of treatment, the mean absolute reduction from baseline was -5·2% (SD 5·4) in the IONIS-DGAT2 Rx  group compared with -0·6% (6·1) in the placebo group (treatment difference -4·2%, 95% CI -7·8 to -0·5, p=0·026). Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo. Six serious adverse events occurred in four patients treated with IONIS-DGAT2 Rx . No serious adverse events were reported in the placebo group. One of four patients reported three serious adverse events: acute exacerbation of chronic obstructive pulmonary disease, cardiac arrest, and ischaemic cerebral infarction, each considered severe and not related to study drug. Three of four patients reported one serious adverse event of increased blood triglycerides (severe, unrelated to study drug), deep-vein thrombosis (severe, unlikely to be related to study drug), and acute pancreatitis (mild, unrelated to study drug).
INTERPRETATION


Our results suggest that DGAT2 antisense inhibition could be a safe and efficacious strategy for treatment of NAFLD and support further investigation in patients with biopsy-proven NASH. Based on the pharmacological target, the response to treatment observed in this study population could extend to the broader population of patients with NAFLD.
FUNDING


Ionis Pharmaceuticals.",2020,"Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo.","['Between Nov 3, 2017, and Nov 28, 2018', '16 clinical research sites in Canada, Poland, and Hungary', 'non-alcoholic fatty liver disease', 'patients with biopsy-proven NASH', 'Eligible participants were aged 18-75 years, had a body-mass index at screening between 27 kg/m 2  and 39 kg/m 2 , haemoglobin A 1c  (HbA 1c ) levels from 7·3% to 9·5%, and liver fat content 10% or greater before randomisation, and agreed to maintain a stable diet and exercise routine throughout the study', '173 people for eligibility', 'patients with type 2 diabetes and NAFLD']","['IONIS-DGAT2', 'subcutaneous injection of 250 mg IONIS-DGAT2', 'diacylglycerol O-acyltransferase', 'Rx  versus placebo', 'placebo']","['liver fat', 'Six serious adverse events', 'Pharmacodynamic performance', 'safety, tolerability, and pharmacodynamic effect of IONIS-DGAT2', 'serious adverse events', 'safety, tolerability, and efficacy', 'blood triglycerides (severe, unrelated to study drug), deep-vein thrombosis (severe', 'serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects', 'serious adverse events: acute exacerbation of chronic obstructive pulmonary disease, cardiac arrest, and ischaemic cerebral infarction']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0163260', 'cui_str': 'Diacylglycerol acyltransferase'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0163260', 'cui_str': 'Diacylglycerol acyltransferase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1262005', 'cui_str': 'Ischaemic cerebral infarction'}]",44.0,0.583485,"Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo.","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA. Electronic address: roloomba@ucsd.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Morgan', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Lynnetta', 'Initials': 'L', 'LastName': 'Watts', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Hannan', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Bhanot', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30186-2']
1269,32554173,Neuroendocrine biomarkers of prolonged exposure treatment response in military-related PTSD.,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone. Preliminary evidence from animal models suggests that baseline levels of these biomarkers may predict response to PTSD treatment. We report the change in biomarkers over the course of PTSD treatment. Biomarkers were sampled from individuals participating in (1) a randomized controlled trial comparing a web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT) and (2) from individuals participating in a nonrandomized effectiveness study testing PE delivered in-person as part of an intensive outpatient PTSD program. We found that higher cortisol reactivity during script-driven imagery was associated with higher baseline PTSD severity and that baseline allopregnanolone, pregnanolone, and cortisol reactivity were associated with degree of symptom change over the course of intensive outpatient treatment. These findings demonstrate that peripherally assessed biomarkers are associated with PTSD severity and likelihood of successful treatment outcome of PE delivered daily over two weeks. These assessments could be used to determine which patients are likely to respond to treatment and which patients require augmentation to increase the likelihood of optimal response to PTSD treatment.",2020,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","['military-related PTSD', 'Posttraumatic stress disorder (PTSD']","['web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT', 'pregnanolone']",['higher cortisol reactivity'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033008', 'cui_str': '3 alpha, 5 beta-Tetrahydroprogesterone'}]","[{'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0279829,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sripada', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA. Electronic address: rekaufma@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: mark.steven.burton@emory.edu.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: vmichop@emory.edu.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kerley', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: kimberly.kerley@emory.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Marx', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: christine.marx@duke.edu.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Kilts', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jason.kilts@duke.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Naylor', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jennifer.naylor@duke.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: brothba@emory.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Rd, Menlo Park, CA, 94025, USA; Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 291 Campus Dr., Stanford, CA, 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Emory University School of Medicine, Department of Obstetrics and Gynecology, 101 Woodruff Circle NE, Ste 4217, Atlanta, 30322, USA. Electronic address: alicia.smith@emory.edu.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: SNorrholm@wayne.edu.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: tjovanovic@med.wayne.edu.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Texas A&M University, 8447 Riverside Parkway, Bryan, TX, 77808-3260, USA. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Col Jeffrey S', 'Initials': 'CJS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Department of Behavioral Health, 36065 Santa Fe Ave., Fort Hood, TX, 76544, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'VA Boston Healthcare System, National Center for PTSD (116B-2), 150 South Huntington Avenue, Boston, MA, 02130, USA; Boston University School of Medicine, Department of Psychiatry, 720 Harrison Avenue, Room 906, Boston, MA, 02118, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA; South Texas Veterans Health Care System, Research and Development Service, 7400 Merton Minter, San Antonio, TX, 78229, USA; University of Texas at San Antonio, Department of Psychology, One UTSA Circle, San Antonio, TX, 78249, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104749']
1270,32559734,"Effects of low fructose diet on glycemic control, lipid profile and systemic inflammation in patients with type 2 diabetes: A single-blind randomized controlled trial.","BACKGROUND AND AIM


Type 2 diabetes is one of the global epidemic disorders, which causes many side effects on the body. Fructose is a lipogenic monosaccharide. Recent studies have reported the adverse effects of this carbohydrate on diabetes. This study aimed to evaluate the clinical efficacy of a low-fructose diet on the metabolic alterations in patients with type 2 diabetes.
METHODS


This study was a randomized, single-blind clinical trial on 50 patients with type 2 diabetes. Participants randomly allocated to two groups, to receive either diabetic-diet or diabetic-diet with low-fructose for 8-weeks. Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors were assessed at baseline and the end of the trial.
RESULTS


At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013). Statistical analysis showed that low-fructose diet compared to control group significantly declined fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP) (P = 0.015, P = 0.001, P=<0.0001, P= <0.0001 and P= <0.0001 respectively).
CONCLUSION


Our results showed that eight weeks of low-fructose diet results in a significant improvement in FBG, HbA1c, TG, HDL-C and hs-CRP in patients with type 2 diabetes.",2020,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","['50 patients with type 2 diabetes', 'patients with type 2 diabetes']","['diabetic-diet or diabetic-diet with low-fructose for 8-weeks', 'low-fructose diet', 'Fructose', 'low fructose diet']","['fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP', 'Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors', 'glycemic control, lipid profile and systemic inflammation', 'body weight, waist circumference, and blood pressure', 'metabolic alterations', 'FBG, HbA1c, TG, HDL-C and hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452314', 'cui_str': 'Low fructose diet'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",50.0,0.074236,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Jalilvand', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran. Electronic address: golbonsohrab@yahoo.com.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.003']
1271,32559735,Improving clinical outcomes of diabetic foot ulcers by the 3-month self- and family management support programs in Indonesia: A randomized controlled trial study.,"BACKGROUND AND AIMS


Diabetic foot ulcers are the leading cause of lower extremity amputations, which require more effective prevention. Even though previous nursing studies on diabetic foot ulcers have been well performed, programs implementing self- and family management are limited and even underexplored. Therefore, the purpose of the study was to investigate the effect of 3-month self- and family management support programs on clinical outcomes among Indonesians with diabetic foot ulcers.
METHOD


The randomized controlled trial design was used to answer the research question of the study. A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group. The experimental group received self- and family management support programs for three months. Meanwhile, the control group received usual care. Descriptive statistics, multivariate analysis of variance, and Generalized Estimating Equations were used to analyze the data. The significance level was considered at .05 for hypothesis testing.
RESULTS


The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
CONCLUSIONS


With regard to the result of the study, implementing the 3-month self- and family management support programs improves the patients' and families' abilities to perform diabetic foot ulcer care at home.",2020,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","['A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group', 'Indonesia', 'Indonesians with diabetic foot ulcers']","['usual care', 'self- and family management support programs']","['self-management, family supports, hemoglobin A1c, and wound size']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",56.0,0.0239313,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05).
","[{'ForeName': 'Sumarno Adi', 'Initials': 'SA', 'LastName': 'Subrata', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand; Department of Nursing and Wound Research Center, Faculty of Health Sciences, Universitas Muhammadiyah Magelang, Indonesia.'}, {'ForeName': 'Rutja', 'Initials': 'R', 'LastName': 'Phuphaibul', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: ruja.phu@mahidol.ac.th.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grey', 'Affiliation': 'Yale University School of Nursing, United States.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Siripitayakunkit', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Noppawan', 'Initials': 'N', 'LastName': 'Piaseu', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.028']
1272,32561603,Combination of human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ treatment synergistically improves the clinical outcomes of patients with rheumatoid arthritis.,"OBJECTIVES


To clarify the key role of circulating interferon-γ (IFN-γ) and to improve the clinical efficacy of mesenchymal stem cell (MSC) transplantation (MSCT) in patients with rheumatoid arthritis (RA).
METHODS


Study of wild-type or IFN-γR -/-  MSCT was first evaluated in a murine model of collagen-induced arthritis (CIA) following which a phase 1/2 randomised controlled study was conducted in 63 patients with RA who responded poorly to regular clinical treatments. Subjects were randomly assigned to an MSCT monotherapy group (n=32) or an MSCT plus recombinant human IFN-γ treatment group (n=31), with 1 year of follow-up. The primary end points consisted of efficacy as assessed as good or moderate EULAR response rates and the proportion of patients at 3 months attaining American College of Rheumatology 20 (ACR20) response rates.
RESULTS


In the murine studies, wild-type MSCT significantly improved the clinical severity of CIA, while IFN-γR -/-  MSCT aggravated synovitis, and joint and cartilage damage. Transitioning from the murine to the clinical study, the 3-month follow-up results showed that the efficacy and ACR20 response rates were attained in 53.3% patients with MSCT monotherapy and in 93.3% patients with MSCT combined with IFN-γ treatment (p<0.05). No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
CONCLUSIONS


The results of this study show that IFN-γ is a key factor in determining the efficacy of MSCT in the treatment of RA, and that an MSC plus IFN-γ combination therapeutic strategy can greatly improve the clinical efficacy of MSC-based therapy in RA patients.",2020,"No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
","['RA patients', '63 patients with RA who responded poorly to regular clinical treatments', 'patients with rheumatoid arthritis (RA', 'patients with rheumatoid arthritis', 'Study of wild-type or']","['circulating interferon-γ (IFN-γ', 'IFN-γ', 'IFN-γR -/-  MSCT', 'MSCT monotherapy', 'mesenchymal stem cell (MSC) transplantation (MSCT', 'human umbilical cord mesenchymal stem (stromal) cell transplantation with IFN-γ', 'MSCT plus recombinant human IFN-γ treatment']","['efficacy and ACR20 response rates', 'clinical severity of CIA, while IFN-γR -/-  MSCT aggravated synovitis, and joint and cartilage damage', 'good or moderate EULAR response rates and the proportion of patients at 3 months attaining American College of Rheumatology 20 (ACR20) response rates']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257990', 'cui_str': 'Stem Cell Transplantation, Mesenchymal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0170509', 'cui_str': 'CyADIC protocol'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0549421', 'cui_str': 'Cartilage damage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",63.0,0.0328702,"No new or unexpected safety issues were encountered in 1-year follow-up for either treatment group.
","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Mengwei', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Force Health Team of 61365 Troops of the Chinese People's Liberation Army, Tianjin, China.""}, {'ForeName': 'Luoquan', 'Initials': 'L', 'LastName': 'Ao', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bellanti', 'Affiliation': 'Departments of Pediatrics and Microbiology-Immunology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Song Guo', 'Initials': 'SG', 'LastName': 'Zheng', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Ohio State University College of Medicine and Wexner Medical Center, Columbus, Ohio, USA xiangxu@tmmu.edu.cn SongGuo.Zheng@osumc.edu.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Stem Cell & Regenerative Medicine, Daping Hospital, Army Military Medical University,Chongqing, Chongqing, China xiangxu@tmmu.edu.cn SongGuo.Zheng@osumc.edu.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217798']
1273,32567356,Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study.,"OBJECTIVE


To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors.
DESIGN


Feasibility randomised controlled study with nested qualitative interview study.
SETTING


The intervention was delivered in the community in either a group or one-to-one format.
SUBJECTS


Carers and stroke survivors within one year of stroke onset.
INTERVENTIONS


A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention.
MAIN OUTCOME


Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation).
RESULTS


Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups.
CONCLUSIONS


Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs.",2020,Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats.,"['Eighteen participants', '257 carers approached, 41 consented', 'stroke carers (BISC', 'carers of stroke survivors', 'Carers and stroke survivors within one year of stroke onset']","['biopsychosocial intervention', 'Biopsychosocial intervention']","['Stroke survivors', 'Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",30.0,0.0489389,Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats.,"[{'ForeName': 'Marion F', 'Initials': 'MF', 'LastName': 'Walker', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Birchall', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cobley', 'Affiliation': 'Department of Clinical Psychology, Derbyshire Healthcare NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Condon', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Fletcher-Smith', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Miriam R', 'Initials': 'MR', 'LastName': 'Golding-Day', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Greensmith', 'Affiliation': 'IAPT Service, Nottinghamshire Healthcare NHS Foundation Trust, UK.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Kontou', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Matias', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Shirley A', 'Initials': 'SA', 'LastName': 'Thomas', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Whitehead', 'Affiliation': 'Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle-Upon-Tyne, UK.'}]",Clinical rehabilitation,['10.1177/0269215520937039']
1274,32563858,Capitalizing on cross-language similarities in intervention with bilingual children.,"PURPOSE


This study examined the effects of a vocabulary intervention for bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates. We measured effects in terms of change from pre- to post-intervention in Spanish as well as associations with the non-target language, English.
METHOD


Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder. Children completed the intervention in pairs (one child with DLD and a typically developing peer) for 70-minute sessions, 3 days a week, for four weeks. Intervention targeted 32 words (16 cognates, 16 non-cognates) using four storybooks (8 words/book) and interactive activities that highlighted similarities across languages. Pre- and post-intervention measures in Spanish and English included tasks of word definition and cognate facilitation.
RESULTS


As a group, children showed improvement in definition quality and cognate naming in Spanish. There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD. All children showed positive cross-language correlations on post-intervention measures.
CONCLUSIONS


Bilingual children, with and without DLD, have the capacity to improve in their awareness and use of cognates. Explicit teaching of cognates can be an effective tool for building vocabulary skills. Children with DLD may need additional time and support to apply their knowledge of cognates to vocabulary learning.",2020,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[""bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates"", 'Children with DLD', 'Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder', 'Spanish and English']",['vocabulary intervention'],"['included tasks of word definition and cognate facilitation', 'definition quality and cognate naming', 'positive cross-language correlations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0437372,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[{'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Dam', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States; University of California San Diego, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: qdam@sdsu.edu.'}, {'ForeName': 'Giang T', 'Initials': 'GT', 'LastName': 'Pham', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: gpham@sdsu.edu.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Pruitt-Lord', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: spruitt@sdsu.edu.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Limon-Hernandez', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: jlimon-hernandez@sdsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Goodwiler', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: cgoodwiler@sdsu.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106004']
1275,32565333,In Vivo Evaluation of Effect of Preoperative Ibuprofen on Proinflammatory Mediators in Irreversible Pulpitis Cases.,"INTRODUCTION


Preoperative administration of nonsteroidal anti-inflammatory drugs has been suggested as a method for increasing the efficacy of local anesthetics and decreasing postoperative pain in symptomatic irreversible pulpitis cases. However, the effects of ibuprofen at the molecular level are still unknown. Hence, the purpose of this study was to compare the levels of proinflammatory mediators in the dental pulp of teeth with irreversible pulpitis in patients who medicated with preoperative ibuprofen versus those who did not.
METHODS


Thirty-four patients undergoing conventional endodontic therapy for teeth with irreversible pulpitis were selected and randomly assigned into either the ibuprofen or nonibuprofen group. Four patients undergoing endodontic therapy for prosthodontic reasons served as controls. Patients in the ibuprofen group were instructed to take 600 mg ibuprofen 1 hour before treatment, whereas patients in the nonibuprofen and control groups were asked to avoid analgesics before treatment. Blood samples obtained from the pulp upon access were tested for levels of prostaglandin E2, tumor necrosis efactor alpha, interleukin (IL)-6, IL-1β, and interferon gamma using high-sensitivity enzyme-linked immunosorbent assay. Postoperative pain levels were recorded for the groups. Data for the cytokine levels and postoperative pain were analyzed using statistical analysis.
RESULTS


There was a significant decrease in the levels of prostaglandin E2, tumor necrosis factor alpha, IL-6, and interferon gamma in the ibuprofen group compared with the nonibuprofen group. No significant differences were noted in the postoperative pain levels between these groups.
CONCLUSIONS


The data showed that preoperative ibuprofen significantly decreased the levels of most proinflammatory cytokines in the dental pulp, which could possibly help with anesthesia in irreversible cases.",2020,"There was a significant decrease in the levels of PGE2, TNF-α, IL-6, and IFN-γ in the ibuprofen group as compared to the non-ibuprofen group.","['irreversible pulpitis cases', 'Four patients undergoing', 'Thirty-four patients undergoing', 'for teeth with irreversible pulpitis', 'dental pulp of teeth with irreversible pulpitis in patients who medicated with pre-operative ibuprofen versus those who did not']","['pre-operative ibuprofen', 'ibuprofen or non-ibuprofen', 'conventional endodontic therapy', 'endodontic therapy', 'ibuprofen']","['post-operative pain levels', 'levels of PGE2, TNF-α, IL-6, and IFN-γ', 'levels of PGE2, TNF-α, IL-6, IL-1β and IFN-γ using high sensitivity ELISAs', 'Post-operative pain levels', 'cytokine levels and post-operative pain', 'levels of most pro-inflammatory cytokines']","[{'cui': 'C0399406', 'cui_str': 'Irreversible pulpitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",4.0,0.0251917,"There was a significant decrease in the levels of PGE2, TNF-α, IL-6, and IFN-γ in the ibuprofen group as compared to the non-ibuprofen group.","[{'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Yen-Wei', 'Initials': 'YW', 'LastName': 'Chen', 'Affiliation': 'Department of Restorative Dentistry, University of Washington, Seattle, Washington.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Johnson', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Avina', 'Initials': 'A', 'LastName': 'Paranjpe', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington. Electronic address: avina@uw.edu.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.009']
1276,32572439,Biomarkers of orthodontic tooth movement with fixed appliances and vibration appliance therapy: a pilot study.,"INTRODUCTION


The aim of this study was to investigate the effect of supplemental vibratory force on biomarkers of bone remodelling during orthodontic tooth movement, the rate of mandibular anterior alignment (RMAA), and compliance with a vibration device.
DESIGN, SETTINGS, AND PARTICIPANTS


Forty patients between the ages 15-35 undergoing fixed appliance treatment that presented to a university orthodontic clinic were randomly allocated to supplemental use of an intraoral vibrational device (n = 20, AcceleDent®) or fixed appliance only (n = 20). Salivary multiplex assay was completed to analyse the concentration of selected biomarkers of bone remodelling before treatment (T0) and at three following time points (T1, T2, T3), 4-6 weeks apart. Irregularity of the mandibular anterior teeth and compliance was assessed at the same trial time points. Data were analysed blindly on an intention-to-treat basis with descriptive statistics, Mann-Whitney U-test, Wilcoxon signed-rank test, and linear mixed effects regression modelling.
RESULTS


No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed. No correlation was found between changes in irregularity and biomarker level from baseline to another time point. Lastly, there was no association between RMAA and compliance with the AcceleDent® device.
CONCLUSIONS


Supplemental vibratory force during orthodontic treatment with fixed appliances does not affect biomarkers of bone remodelling or the RMAA.
LIMITATIONS


The main limitation of the study was the small sample size and the large variability in the salivary biomarkers.
HARMS


No harms were observed during the duration of the trial.
PROTOCOL


The protocol was not published prior to trial commencement.
REGISTRATION


The study was registered in Clinical Trials.gov (NCT02119455) first posted on April 2014.",2020,No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed.,['Forty patients between the ages 15-35 undergoing fixed appliance treatment that presented to a university orthodontic clinic'],"['fixed appliances and vibration appliance therapy', 'intraoral vibrational device (n = 20, AcceleDent®) or fixed appliance', 'supplemental vibratory force']","['salivary biomarkers of bone remodelling and RMAA', 'rate of mandibular anterior alignment (RMAA), and compliance with a vibration device', 'irregularity and biomarker level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.100189,No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed.,"[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Reiss', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Marie Claude', 'Initials': 'MC', 'LastName': 'Chouinard', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Dasha', 'Initials': 'D', 'LastName': 'Frias Landa', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Taranpreet', 'Initials': 'T', 'LastName': 'Chandhoke', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Sobue', 'Affiliation': 'Division of Periodontics, Department of Oral Health and Diagnostic Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Veerasathpurush', 'Initials': 'V', 'LastName': 'Allareddy', 'Affiliation': 'Department of Orthodontics, College of Dentistry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chia-Ling', 'Initials': 'CL', 'LastName': 'Kuo', 'Affiliation': 'CICATS/Department of Community Medicine/Institute for System Genomics, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Jinjian', 'Initials': 'J', 'LastName': 'Mu', 'Affiliation': 'CICATS/Department of Community Medicine/Institute for System Genomics, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Uribe', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}]",European journal of orthodontics,['10.1093/ejo/cjaa026']
1277,32475771,"Corrigendum to ""Effect of patient education on palliative care knowledge and acceptability of outpatient palliative care services among gynecologic oncology patients: A randomized controlled trial"" [Gynecol. Oncol. 156 (2020) 482-487].",,2020,,"['156 (2020', 'gynecologic oncology patients']",[],[],"[{'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0849144,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Graul', 'Affiliation': ""Department of Gynecologic Oncology, St. Luke's University Health System, Bethlehem, PA, United States of America. Electronic address: Ashley.graul@sluhn.org.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haggerty', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stickley', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Palliative Care, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bogner', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ko', 'Affiliation': 'Department of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.015']
1278,32477416,"Correction to: Protocol for a double-blind, randomized controlled trial on the dose-related efficacy of omalizumab in multi-food oral immunotherapy.",[This corrects the article DOI: 10.1186/s13223-020-00419-z.].,2020,[This corrects the article DOI: 10.1186/s13223-020-00419-z.].,[],['omalizumab'],[],[],"[{'cui': 'C0966225', 'cui_str': 'omalizumab'}]",[],,0.546869,[This corrects the article DOI: 10.1186/s13223-020-00419-z.].,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlois', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Lavergne', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Leroux', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Killer', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Azzano', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Paradis', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Samaan', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lacombe-Barrios', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eiwegger', 'Affiliation': '4Division of Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, The University of Toronto, Toronto, ON Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Upton', 'Affiliation': '4Division of Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, The University of Toronto, Toronto, ON Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Gordon Sussman Clinical Research, Toronto, ON Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Poder', 'Affiliation': '6Department of Management, Evaluation and Health Policy, School of Public Health, Université de Montréal, Montreal, QC Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Mâsse', 'Affiliation': 'Centre Hospitalier Sainte-Justine Research Center, Montreal, QC Canada.'}, {'ForeName': 'Anne Des', 'Initials': 'AD', 'LastName': 'Roches', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bégin', 'Affiliation': '1Department of Allergy and Immunology, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC Canada.'}]","Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology",['10.1186/s13223-020-00435-z']
1279,32554766,Goals-of-care decision aid for critically ill patients with TBI: Development and feasibility testing.,"OBJECTIVE


To develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.
METHODS


We developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.
RESULTS


The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent""). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician-family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.
CONCLUSIONS


Our systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.",2020,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","['18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label', '16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date', 'critically ill patients with TBI', 'patients who are critically ill with traumatic brain injury (ciTBI']","['36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing']",['acceptability'],"[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",12.0,0.089653,"The resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0-100]) and acceptability (97% graded the tool's content as ""good"" or ""excellent"").","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Muehlschlegel', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA. susanne.muehlschlegel@umassmemorial.org.'}, {'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Hwang', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Flahive', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Moskowitz', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Goostrey', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Jolanta J', 'Initials': 'JJ', 'LastName': 'Pach', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Knies', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Shutter', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldberg', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'From the Departments of Neurology (S.M., C.L., K.G., K.J.), Anesthesiology/Critical Care (S.M.), Surgery (S.M.), Population and Quantitative Health Sciences (J.F., R.G.), Meyers Primary Care Institute (K.M.M.), and Internal Medicine (K.M.M.), University of Massachusetts Medical School, Worcester; Center for Neuroepidemiology and Clinical Neurological Research (D.Y.H.) and Department of Neurology (D.Y.H., J.J.P., A.K.K.), Yale School of Medicine, New Haven, CT; Department of Medicine (T.Q.), Beth Israel Deaconess Hospital, Harvard Medical School, Boston, MA; Department of Psychiatry (J.M.), Brown Medical School, Providence, RI; and Departments of Critical Care Medicine and Neurology (L.S.), University of Pittsburgh School of Medicine, PA.'}]",Neurology,['10.1212/WNL.0000000000009770']
1280,32567012,Phase II multi-institutional prospective trial of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer refractory to fluoropyrimidine with modified dose reduction criteria (CCOG1303).,"BACKGROUND


The aim of this study was to explore the efficacy and safety of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer with modified dose reduction criteria by which the doses were manipulated earlier.
METHODS


Gastric cancer patients who developed progression during the fluoropyrimidine-containing first-line chemotherapy were assigned to receive nab-paclitaxel (260 mg/m 2 ) by triweekly administration. Dose reduction was regulated according to predefined toxicity criteria which included neutropenia less than 1000/mm 3  and/or peripheral sensory neuropathy of grade 2 or more. The primary endpoint was progression-free survival.
RESULTS


A total of 50 patients were enrolled, 47 of whom were eligible for efficacy analyses. The median number of treatment cycles and relative dose intensity given per patient was four (range 1-25), and 90% (range 60-100). Of total administration throughout the trial of 280 cycles, dose reduction was required in 50 cycles. The median progression-free survival was 3.5 months (95% confidence interval 2.5-4.4) that met the primary endpoint. The median overall survival was 9.0 months (95% confidence interval 6.8-11.8), overall response rate was 16% (95% confidence interval 2-30), and disease control rate was 72% (95% confidence interval 54-90). The median time to treatment failure was 3.5 months (95% confidence interval 2.5-4.4). Adverse events of grade 3 or worse included neutropenia in 49%, and peripheral sensory neuropathy in 11%. Febrile neutropenia occurred only in one patient (2%).
CONCLUSION


The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.",2020,The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.,"['A total of 50 patients were enrolled, 47 of whom were eligible for efficacy analyses', 'advanced gastric cancer', 'advanced gastric cancer refractory to', 'Gastric cancer patients who developed progression during the fluoropyrimidine-containing first-line chemotherapy']","['fluoropyrimidine', 'nab-paclitaxel']","['disease control rate', 'median number of treatment cycles', 'median progression-free survival', 'progression-free survival', 'median time to treatment failure', 'severe peripheral sensory neuropathy', 'efficacy and safety', 'overall response rate', 'Adverse events of grade 3 or worse included neutropenia', 'median overall survival', 'peripheral sensory neuropathy', 'Febrile neutropenia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}]",50.0,0.32366,The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.,"[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. kobadai@med.nagoya-u.ac.jp.'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Surgery, Komaki City Hospital, Komaki, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Torii', 'Affiliation': 'Department of Surgery, Meitetsu Hospital, Nagoya, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takeda', 'Affiliation': 'Department of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Kawase', 'Affiliation': 'Department of Surgery, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ishigure', 'Affiliation': 'Department of Surgery, Konan Kosei Hospital, Konan, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Teramoto', 'Affiliation': 'Department of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kodera', 'Affiliation': 'Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01724-8']
1281,32563939,Association of Meteorin-Like Hormone with insulin resistance and body composition in healthy Iranian adults.,"BACKGROUND AND AIMS


Sedentary behavior and/or physical inactivity are modifiable risk factors for noncommunicable diseases. Myokines are one of the mediators of physical activity health benefits. Relationship between regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl) has not been explored in human. Hence, we compared baseline plasma Metrnl between sedentary individuals and ones with recreational physical activities, and role of Metrnl as a biological messenger between physical activity and insulin resistance and body composition was also explored.
METHODS


Forty healthy young men (aged: 21 ± 2.1 yrs; BMI: 23 ± 3.44 kg/m 2 ) completed the study. Participants were equally assigned into two groups of control (sedentary) and case (recreational athletes). Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
RESULTS


Except for baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage were similar between two groups (P > 0.05). However, after Metrnl correction for the degree of insulin resistance index (Metrnl/HOMA-IR), recreational athletes showed a significantly greater baseline compared to sedentary subjects (P < 0.05). Baseline blood glucose showed a negative and significant correlation with baseline plasma Metrnl (P < 0.05).
CONCLUSIONS


Baseline plasma Metrnl is correlated with regular physical activity and insulin sensitivity, but not with body composition parameters. Metrnl may be one possible mediator of the beneficial effects of PA on insulin sensitivity in healthy humans. Hence, increasing awareness of the benefits of physical activity and incorporating physical activity into lifestyle are of great importance for people with non-communicable diseases.",2020,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","['healthy humans', 'Forty healthy young men (aged: 21\xa0±\xa02.1\xa0yrs', 'people with non-communicable diseases', 'healthy Iranian adults']","['Meteorin-Like Hormone with insulin resistance and body composition', 'regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl']","['Baseline blood glucose', 'degree of insulin resistance index (Metrnl/HOMA-IR', 'baseline plasma Metrnl', 'baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage', 'Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0269477,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sport Sciences, University of Mazandaran, Babolsar, Mazandaran, Iran. Electronic address: h.alizadeh.aw@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Sport Physiology, Faculty of Sport Sciences, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: aliakbar.alizadeh1984@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.031']
1282,31836178,"Perioperative tight glycemic control using artificial pancreas decreases infectious complications via suppression of inflammatory cytokines in patients who underwent pancreaticoduodenectomy: A prospective, non-randomized clinical trial.","BACKGROUND


We sought to investigate the efficacy of perioperative tight glycemic control (TGC) in reducing of postoperative infectious complications (POICs) and study its impact on early inflammatory mediators in patients who underwent pancreaticoduodenectomy.
METHODS


In this non-randomized trial, the artificial pancreas (AP) group received TGC (target glucose range of 80-110 mg/dL; n = 14), while the control group received conventional glycemic control (range of 80-180 mg/dL; n = 15). The primary endpoint was POICs.
RESULTS


The AP group had a markedly decreased POIC rate (28.6% vs. 73.3%; P = 0.027), mean glycemic variability (13.5 ± 3.5% vs. 16.4 ± 5.9%; P = 0.038), and plasma interleukin-6 level (26.3 ± 33.8 vs 98.3 ± 89.1 pg/ml; P = 0.036) compared to the control group, but insulin dosage (27.0 ± 13.4 vs. 10.2 ± 16.2 U; P = 0.002) and the adiponectin ratio (i.e., postoperative/preoperative adiponectin; 0.8 ± 0.2 vs. 0.6 ± 0.3; P = 0.021) were markedly higher in the AP group.
CONCLUSIONS


Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs.
SUMMARY


Perioperative hyperglycemia increases postoperative infectious complications; however, tight glycemic control using artificial pancreas can reduce them via a dual effect. Artificial pancreas facilitates strict and safe glycemic control while reducing anti-inflammatory mediators, including adiponectin, following pancreaticoduodenectomy.",2020,"Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs.
","['patients who underwent', 'patients who underwent pancreaticoduodenectomy', 'patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control']","['pancreaticoduodenectomy', 'artificial pancreas', 'artificial pancreas (AP) group received TGC', 'perioperative tight glycemic control (TGC', 'conventional glycemic control']","['mean glycemic variability', 'adiponectin ratio', 'POIC rate', 'plasma interleukin-6 level', 'POICs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0612314,"Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs.
","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Akabori', 'Affiliation': 'Department of Surgery, Shiga, Japan. Electronic address: hakabori@belle.shiga-med.ac.jp.'}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kitamura', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Maehira', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Imashuku', 'Affiliation': 'Department of Anesthesiology, Shiga, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tsujita', 'Affiliation': 'Department of Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Anesthesiology, Shiga, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.12.008']
1283,32572652,Ticagrelor Versus Clopidogrel in Patients with Late or Very Late Stent Thrombosis.,"PURPOSE


To compare the effect of ticagrelor with clopidogrel in reducing the risk of ischemic cardiovascular events in patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI).
METHODS


A total of 4538 patients with acute coronary syndrome were screened for angiographically determined LST/VLST. Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n = 81) or clopidogrel (n = 160) at discharge. The clinical outcome was major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period.
RESULTS


After propensity score matching, 65 pairs were generated. The incidence of MACE was significantly lower in the ticagrelor group compared with the clopidogrel group (9.3% vs. 21.5%, log-rank p = 0.048). However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
CONCLUSION


Following successful primary PCI, patients with LST/VLST who received ticagrelor had fewer ischemic cardiovascular events at 1-yr follow-up, compared with those who received clopidogrel.",2020,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
","['patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI', 'n\u2009=\u2009160) at discharge', 'Patients with Late or Very Late Stent Thrombosis', 'Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n\u2009=\u200981) or', '4538 patients with acute coronary syndrome']","['ticagrelor with clopidogrel', 'Ticagrelor Versus Clopidogrel', 'clopidogrel', 'ticagrelor']","['incidence of MACE', 'event rates of death, MI, ischemic stroke, and revascularization', 'ischemic cardiovascular events', 'major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",4538.0,0.0802211,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
","[{'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Sheng', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Runzhen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. hbyanfuwai2018@163.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07021-w']
1284,32568845,Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial.,"BACKGROUND


The effect of anesthetic drugs on cancer outcomes remains unclear. This trial aimed to assess postoperative circulating tumor cell counts-an independent prognostic factor for breast cancer-to determine how anesthesia may indirectly affect prognosis. It was hypothesized that patients receiving sevoflurane would have higher postoperative tumor cell counts.
METHODS


The parallel, randomized controlled trial was conducted in two centers in Switzerland. Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible. The patients were randomly assigned to either sevoflurane or propofol anesthesia. The patients and outcome assessors were blinded. The primary outcome was circulating tumor cell counts over time, assessed at three time points postoperatively (0, 48, and 72 h) by the CellSearch assay. Secondary outcomes included maximal circulating tumor cells value, positivity (cutoff: at least 1 and at least 5 tumor cells/7.5 ml blood), and the association between natural killer cell activity and tumor cell counts. This trial was registered with ClinicalTrials.gov (NCT02005770).
RESULTS


Between March 2014 and April 2018, 210 participants were enrolled, assigned to sevoflurane (n = 107) or propofol (n = 103) anesthesia, and eventually included in the analysis. Anesthesia type did not affect circulating tumor cell counts over time (median circulating tumor cell count [interquartile range]; for propofol: 1 [0 to 4] at 0 h, 1 [0 to 2] at 48 h, and 0 [0 to 1] at 72 h; and for sevoflurane: 1 [0 to 4] at 0 h, 0 [0 to 2] at 48 h, and 1 [0 to 2] at 72 h; rate ratio, 1.27 [95% CI, 0.95 to 1.71]; P = 0.103) or positivity. In one secondary analysis, administrating sevoflurane led to a significant increase in maximal tumor cell counts postoperatively. There was no association between natural killer cell activity and circulating tumor cell counts.
CONCLUSIONS


In this randomized controlled trial investigating the effect of anesthesia on an independent prognostic factor for breast cancer, there was no difference between sevoflurane and propofol with respect to circulating tumor cell counts over time.",2020,"There was no association between natural killer cell activity and circulating tumor cell counts.
","['nonmetastatic and metastatic breast cancer', 'n = 103) anesthesia, and eventually included in the analysis', 'Between March 2014 and April 2018, 210 participants were enrolled, assigned to', 'n = 107) or', 'Patients aged 18 to 85 yr without metastases and scheduled for primary breast cancer surgery were eligible', 'two centers in Switzerland', 'primary breast cancer patients receiving', 'Primary Breast Cancer Patients']","['sevoflurane anesthesia', 'sevoflurane and propofol', 'sevoflurane or propofol anesthesia', 'sevoflurane', 'propofol']","['natural killer cell activity and tumor cell counts', 'maximal tumor cell counts postoperatively', 'maximal circulating tumor cells value, positivity (cutoff', 'circulating tumor cell counts', 'natural killer cell activity and circulating tumor cell counts', 'postoperative tumor cell counts']","[{'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",210.0,0.167967,"There was no association between natural killer cell activity and circulating tumor cell counts.
","[{'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Hovaguimian', 'Affiliation': 'From the Institute of Anesthesiology, University Hospital of Zurich and University of Zurich, Zurich, Switzerland (F.H., M.S., B.B.-S.) the Epidemiology, Biostatistics and Prevention Institute, Department of Public and Global Health (F.H.) the Epidemiology, Biostatistics and Prevention Institute, Department of Epidemiology (J.B., M.A.P.) the Institute of Physiology and Zurich Center for Integrative Human Physiology (B.R.Z., M.S., B.B.-S.) the Cytometry Facility (C.D., C.E.), University of Zurich, Zurich, Switzerland the Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland (K.J.D., D.F.) the Institute of Anesthesiology, Hirslanden Clinic Zurich, Zurich, Switzerland (U.R., M.S.) the Faculty of Medicine, University of Basel, Basel, Switzerland (M.S.) the Department of Surgery (C.T.) the Clinical Trial Unit (B.P.), Breast Center Zurich, Zurich, Switzerland the Department of Anesthesiology, University of Illinois College of Medicine at Chicago, Chicago, Illinois (B.B.-S.).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': ''}, {'ForeName': 'Birgit Roth', 'Initials': 'BR', 'LastName': ""Z'graggen"", 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schläpfer', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dumrese', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ewald', 'Affiliation': ''}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': ''}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Rölli', 'Affiliation': ''}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Seeberger', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Tausch', 'Affiliation': ''}, {'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Papassotiropoulos', 'Affiliation': ''}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Beck-Schimmer', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003409']
1285,32569643,Effect of the SafeCare© intervention on parenting outcomes among parents in child welfare systems: A cluster randomized trial.,"Child maltreatment has long-lasting negative impacts, and interventions are needed to improve caregiver's parenting skills to prevent maltreatment. This paper reports on a randomized trial comparing the SafeCare© model to services as usual (SAU) for child-welfare referred caregivers. SafeCare is an 18-session behavioral parenting program that teaches skills in positive parent-child interactions, home safety, and child health. SAU is generally unstructured and includes support, crisis management, referrals for need, and parenting education. Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers). Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment. Assessments measured positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales. Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29. Latent change score models (LCSM) using a sandwich estimator consistent with the trial design were used to examine changes in 13 outcomes. Results indicated that SafeCare had small to medium effects for improving several parenting outcomes including supporting positive child behaviors (d = 0.46), proactive parenting (d = 0.25), and two aspects of parenting stress (d = 0.28 and .30). No differential change between groups was found for other indicators, including all indicators of neglect. Parenting programs such as SafeCare offer a promising mode of intervention for child welfare systems. Scale-up of parenting programs can improve parenting, improve child outcomes, and potentially reduce maltreatment. CLINICALTRIAL.GOV REGISTRATION NUMBER: NCT02549287.",2020,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"['Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29', 'child-welfare referred caregivers', 'Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or', 'parents in child welfare systems', 'Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment']","['continue SAU', 'SafeCare']","['several parenting outcomes including supporting positive child behaviors', 'proactive parenting', 'positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales', 'parenting outcomes']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",288.0,0.0742896,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': 'Georgia State University, United States of America. Electronic address: Dwhitaker@gsu.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Self-Brown', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Osborne', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Weeks', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Reidy', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'Georgia State University, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106167']
1286,32576882,Author Correction: Kinesiologist-guided functional exercise in addition to intradialytic cycling program in end-stage kidney disease patients: a randomised controlled trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['end-stage kidney disease patients'],"['intradialytic cycling program', 'Author Correction: Kinesiologist-guided functional exercise']",[],"[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}]",[],,0.0729056,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Pajek', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jadranka Buturović', 'Initials': 'JB', 'LastName': 'Ponikvar', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Vedran', 'Initials': 'V', 'LastName': 'Hadžić', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia. maja.pajek@fsp.uni-lj.si.'}]",Scientific reports,['10.1038/s41598-020-67057-8']
1287,32577745,Effect of Thyroid Hormone Therapy on Fatigability in Older Adults With Subclinical Hypothyroidism: A Nested Study Within a Randomized Placebo-Controlled Trial.,"BACKGROUND


Fatigue often triggers screening for and treatment of subclinical hypothyroidism. However, data on the impact of levothyroxine on fatigue is limited and previous studies might not have captured all aspects of fatigue.
METHOD


This study is nested within the randomized, placebo-controlled, multicenter TRUST trial, including community-dwelling participants aged ≥65 and older, with persistent subclinical hypothyroidism (TSH 4.60-19.99 mIU/L, normal free thyroxine levels) from Switzerland and Ireland. Interventions consisted of daily levothyroxine starting with 50 μg (25 μg if weight <50 kg or known coronary heart diseases) together with dose adjustments to achieve a normal TSH and mock titration in the placebo group. Main outcome was the change in physical and mental fatigability using the Pittsburgh Fatigability Scale over 1 year, assessed through multivariable linear regression with adjustment for country, sex, and levothyroxine starting dose.
RESULTS


Among 230 participants, the mean ± standard deviation (SD) TSH was 6.2 ± 1.9 mIU/L at baseline and decreased to 3.1 ± 1.3 with LT4 (n = 119) versus 5.3 ± 2.3 with placebo (n = 111, p < .001) after 1 year. After adjustment we found no between-group difference at 1 year on perceived physical (0.2; 95% CI -1.8 to 2.1; p = .88), or mental fatigability (-1.0; 95% CI -2.8 to 0.8; p = .26). In participants with higher fatigability at baseline (≥15 points for the physical score [n = 88] or ≥13 points for the mental score [n = 41]), the adjusted between-group differences at 1 year were 0.4 (95% CI -3.6 to 2.8, p = .79) and -2.2 (95% CI -8.8 to 4.5, p = .51).
CONCLUSIONS


Levothyroxine in older adults with mild subclinical hypothyroidism provides no change in physical or mental fatigability.",2020,"After adjustment we found no between-group difference at 1 year on perceived physical (0.2; 95% CI -1.8 to 2.1; p = .88), or mental fatigability (-1.0; 95% CI -2.8 to 0.8; p = .26).","['community-dwelling participants aged ≥65 and older, with persistent subclinical hypothyroidism (TSH 4.60-19.99 mIU/L, normal free thyroxine levels) from Switzerland and Ireland', 'Older Adults With Subclinical Hypothyroidism', 'older adults with mild subclinical hypothyroidism']","['levothyroxine', 'Placebo', 'Levothyroxine', 'Thyroid Hormone Therapy', 'placebo']","['mental fatigability', 'change in physical and mental fatigability using the Pittsburgh Fatigability Scale', 'mean ± standard deviation (SD) TSH']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0439462', 'cui_str': 'mIU/L'}, {'cui': 'C0861033', 'cui_str': 'Thyroxine free normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]",230.0,0.736424,"After adjustment we found no between-group difference at 1 year on perceived physical (0.2; 95% CI -1.8 to 2.1; p = .88), or mental fatigability (-1.0; 95% CI -2.8 to 0.8; p = .26).","[{'ForeName': 'Mirah J', 'Initials': 'MJ', 'LastName': 'Stuber', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Del Giovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'Departments of Medicine and Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes, Nutrition and Therapeutic Education, Geneva University Hospitals, Switzerland.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Internal Medicine, Section Gerontology and Geriatrics, Leiden University Center, the Netherlands.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Mooijaart', 'Affiliation': 'Department of Internal Medicine, Section Gerontology and Geriatrics, Leiden University Center, the Netherlands.'}, {'ForeName': 'Vera J C', 'Initials': 'VJC', 'LastName': 'McCarthy', 'Affiliation': 'School of Nursing and Midwifery, University College Cork, Ireland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, Switzerland.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular Medicine, University of Glasgow, Scotland.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of Epidemiology, Center for Aging and Population Health, Graduate School of Public Health, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Ireland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa123']
1288,32574773,Macular and Peripapillary Optical Coherence Tomography Angiography Metrics Predict Progression in Diabetic Retinopathy: A Sub-analysis of TIME-2b Study Data.,"PURPOSE


To identify optical coherence tomography angiography (OCTA)-derived vessel metrics of the macula and optic nerve head (ONH) that predict diabetic retinopathy (DR) disease progression.
DESIGN


Secondary analysis of clinical trial data.
METHODS


This was a sub-analysis of prospectively collected data from 73 subjects that participated in the TIME-2b study (Aerpio Pharmaceuticals), a multicenter clinical trial for patients with moderate-to-severe DR treated with AKB-9778 and followed over a 12-month period. Eligible subjects were tested every 3 months with color fundus photography, spectral-domain OCT, and slit-lamp biomicroscopy. OCTA of the macula and ONH was obtained for a subset of patients enrolled at participating sites. En face, full-depth retinal projections centered at the macula were analyzed for multiple metrics including foveal avascular zone (FAZ) area and perimeter, nonperfusion area, vessel density (VD), and presence of intraretinal microvascular abnormalities (IRMA). VD of the radial peripapillary capillaries was evaluated in 4 quadrants surrounding the optic disc for ONH images. Progression was defined as a ≥2-step increase in DR severity scale score or development of diabetic macular edema.
RESULTS


Over a follow-up period of 12 months, 15 of 73 (20.5%) subjects progressed. At pretreatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
CONCLUSIONS


FAZ area and temporal peripapillary VD are predictors of DR progression. OCTA metrics may improve progression risk assessment in DR when compared to established risk factors alone.",2020,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","['Diabetic Retinopathy', '73 subjects that participated in the TIME-2b Study (Aerpio Pharmaceuticals), a multi-center clinical trial for patients with moderate to severe DR treated with AKB-9778 and followed over a 12-month period']","['color fundus photography, spectral domain OCT and slit-lamp biomicroscopy', 'optical coherence tomography angiography (OCTA']","['larger FAZ area, presence of IRMA, and reduced peripapillary VD', 'DR severity scale score or development of diabetic macular edema', 'foveal avascular zone (FAZ) area and perimeter, non-perfusion area, vessel density (VD) and presence of intraretinal microvascular abnormalities (IRMA']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4043862', 'cui_str': 'AKB-9778'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",73.0,0.0248145,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Custo Greig', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Brigell', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Levine', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Moult', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Fujimoto', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA. Electronic address: nadiakwaheed@gmail.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.009']
1289,32441987,A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.,"Rationale:  Low and slow patient enrollment remains a barrier to critical care randomized controlled trials (RCTs). Behavioral economic insights suggest that nudges may address some enrollment challenges. Objectives:  To evaluate the efficacy of a novel preconsent survey consisting of nudges on critical care RCT enrollment. Methods:  We conducted an RCT in 10 intensive care units (ICUs) among surrogate decision-makers (SDMs). The novel multicomponent behavioral nudge survey was administered immediately before soliciting SDMs' informed consent for their patients' participation in a sham trial of two mechanical ventilation weaning approaches in acute respiratory failure. The primary outcome was the enrollment rate for the sham trial. Secondary outcomes included undue and unjust inducements. We also explored SDM and patient predictors of enrollment using multivariate regression. Results:  Among 182 SDMs, 93 were randomized to receive the intervention survey and 89 to receive standard informed consent. There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference, 5%; 95% confidence interval [CI], -9% to 18%;  P  = 0.50). There was no evidence of undue or unjust inducement. White SDMs were more likely to enroll the patient compared with non-white SDMs (odds ratio, 3.7; 95% CI, 1.1 to 12.2;  P  = 0.03). SDMs who perceived a higher risk of participation were less likely to enroll the patient (odds ratio, 0.57; 95% CI, 0.46 to 0.71;  P  < 0.001). Conclusions:  A preconsent behavioral nudge survey among SDMs of patients with acute respiratory failure in the ICU did not increase enrollment rates for a sham RCT compared with standard informed consent procedures.Clinical trial registered with ClinicalTrials.gov (NCT03284359).",2020,"There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference 5%; 95% CI, -9% to 18%, p=0.50).",['10 intensive care units (ICUs) among surrogate decision-makers (SDMs'],['mechanical ventilation weaning approaches'],"['enrollment rate', 'enrollment rates', 'Caucasian SDMs', 'undue and unjust inducements']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0554244', 'cui_str': 'Maker'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]",2.0,0.317179,"There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference 5%; 95% CI, -9% to 18%, p=0.50).","[{'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Krutsinger', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': ""O'Leary"", 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics.'}, {'ForeName': 'Cody E', 'Initials': 'CE', 'LastName': 'Cotner', 'Affiliation': 'Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Courtright', 'Affiliation': 'Palliative and Advanced Illness Research Center.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202003-194OC']
1290,32442523,"Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial.","BACKGROUND


The globally synchronised introduction of inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV) were successfully implemented in China's routine immunisation programme in May, 2016. In response to the global shortage of Salk-strain IPV, Sabin-strain IPV production was encouraged to develop and use in low-income and middle-income countries. We assessed the immunogenicity of the current routine poliovirus vaccination schedule in China and compared it with alternative schedules that use Sabin-strain IPV (sIPV) and bOPV.
METHODS


This open-label, randomised, controlled trial recruited healthy infants aged 60-75 days from two centres in Zhejiang, China. Eligible infants were full-term, due for their first polio vaccination, weighed more than 2·5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination. Infants were randomly assigned (1:1:1) using permuted block randomisation (block size of 12) to one of three polio vaccination schedules, with the first, second, and third doses given at ages 2 months, 3 months, and 4 months, respectively: sIPV-bOPV-bOPV (1sIPV+2bOPV group; current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group). The primary endpoint was the proportion of infants with seroconversion to each of the three poliovirus serotypes 1 month after the third dose. Serious and medically important adverse events were monitored for up to 30 days after each vaccination. We assessed immunity in the per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine. This trial is registered with Clinicaltrials.gov, NCT03147560.
RESULTS


Between May 1, 2016, and Dec 1, 2017, we enrolled and randomly assigned 528 eligible infants to one of the three treatment groups (176 in each group); 473 infants (158 in the 1sIPV+2bOPV group, 152 in the 2sIPV+1bOPV group, and 163 in the 3sIPV group) were included in the per-protocol population. 100% seroconversion against poliovirus types 1 and 3 was observed in all three groups. Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001). Seroconversion against type 2 poliovirus was observed in 98 (62%) infants in the 1sIPV+2bOPV group, 145 (95%) infants in the 2sIPV+1bOPV group, and 161 (99%) infants in the 3sIPV group. No serious adverse events occurred during the study; 14 minor, transient adverse events were observed, with no significant differences across study groups.
INTERPRETATION


All three study schedules were well tolerated and highly immunogenic against poliovirus types 1 and 3. Schedules containing two or three sIPV doses had higher seroconversion rates against poliovirus type 2 than did the schedule with a single dose of sIPV. Our findings support inclusion of two sIPV doses in the routine poliovirus vaccination schedule in China to provide better protection against poliovirus type 2 than provided by the current regimen.
FUNDING


Chinese Center for Disease Control and Prevention and China National Biotec Group Company.",2020,Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001).,"['healthy infants aged 60-75 days from two centres in Zhejiang, China', 'per-protocol population (all children who completed all three vaccinations and had pre-vaccination and post-vaccination laboratory data) and safety in all children who received at least one dose of study vaccine', 'Eligible infants were full-term, due for their first polio vaccination, weighed more than 2·5 kg at birth, were healthy on physical examination with no obvious medical conditions, and had no contraindications to vaccination', '528 eligible infants to one of the three treatment groups (176 in each group); 473 infants (158 in the 1sIPV+2bOPV group, 152 in the 2sIPV+1bOPV group, and 163 in the 3sIPV group) were included in the per-protocol population', 'Zhejiang, China']","['inactivated poliovirus vaccine (IPV) and replacement of trivalent oral poliovirus vaccine (OPV) with bivalent OPV (bOPV', 'sIPV-bOPV-bOPV (1sIPV+2bOPV group; current regimen), sIPV-sIPV-bOPV (2sIPV+1bOPV group), or sIPV-sIPV-sIPV (3sIPV group', 'Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine']","['Seroconversion against type 2 poliovirus', 'seroconversion rates', 'serious adverse events', 'transient adverse events', 'antibody titres against poliovirus types', 'proportion of infants with seroconversion', 'Immunogenicity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0419714', 'cui_str': 'First polio vaccination'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0852650', 'cui_str': 'Contraindication to vaccination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",528.0,0.155858,Infants who received an immunisation schedule containing bOPV had significantly higher antibody titres against poliovirus types 1 and 3 than did the sIPV-only group (2048 in all three treatment groups; p<0·0001).,"[{'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Chenyan', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Immunisation Programme Department, Hangzhou Municipal Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Immunisation Programme Department, Quzhou Municipal Center for Disease Control and Prevention, Quzhou, Zhejiang, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Immunisation Programme Department, Chun'an County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Zhongbing', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Immunisation Programme Department, Longyou County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Shuyun', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wen', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'An', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Immunisation Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China. Electronic address: zhpchen@cdc.zj.cn.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: wanghq@chinacdc.cn.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30738-8']
1291,32581088,Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.,"OBJECTIVES


Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial.
METHODS


Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m 2 ) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse.
RESULTS


188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections.
CONCLUSIONS


This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.",2020,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","['Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis', 'patients with relapsing AAV treated with', 'patients enrolled into the induction phase of the RITAZAREM trial', '188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years', 'patients with AAV who have relapsed, with a similar safety profile to previous studies']","['cyclophosphamide', 'rituximab and glucocorticoids', 'Rituximab', 'remission-induction therapy with rituximab (4×375\u2009mg/m 2 ) and a higher or lower dose glucocorticoid regimen', 'rituximab in conjunction with glucocorticoids', 'rituximab']",['41 severe adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",188.0,0.0880274,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","[{'ForeName': 'Rona M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'University of Cambridge, Cambridge, UK ronasmith@doctors.net.uk.'}, {'ForeName': 'Rachel Bronwen', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Nodale', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Aljayyousi', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Camilleri', 'Affiliation': 'Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chee Kay', 'Initials': 'CK', 'LastName': 'Cheung', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Vimal', 'Initials': 'V', 'LastName': 'Derebail', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Doulton', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.'}, {'ForeName': 'Lindsy', 'Initials': 'L', 'LastName': 'Forbess', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Furuta', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Gewurz-Singer', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Klocke', 'Affiliation': 'Dudley Group NHS Foundation Trust, Dudley, West Midlands, UK.'}, {'ForeName': 'Curry', 'Initials': 'C', 'LastName': 'Koening', 'Affiliation': 'University of Utah Vasculitis Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Komagata', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Rheumatology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Raashid Ahmed', 'Initials': 'RA', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science (NDORMs), University of Oxford, Oxford, UK.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama Universty Hospital, Okayama, Japan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'McAlear', 'Affiliation': 'Division of Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monach', 'Affiliation': 'Division of Rheumatology, VA Boston Healthcare System, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Moreland', 'Affiliation': 'University of Pittsburg, Pittsburg, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mynard', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nachman', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Rennie L', 'Initials': 'RL', 'LastName': 'Rhee', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'HSS, New York, New York, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Weisman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wroe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, Middlesbrough, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216863']
1292,32569934,Metabolic tracking of isoflavones in soybean products and biosamples from healthy adults after fermented soybean consumption.,"Fermentation may enhance the nutritional properties of foods by increasing metabolite bioactivity or bioavailability. This study explored the effect of fermentation on isoflavone bioavailability and metabolism. Isoflavone metabolites were tracked in foods and biospecimens of healthy adults after fermented soybean (FS) or non-fermented soybean (NFS) consumption in a randomized, controlled, crossover intervention study. The change in soybean isoflavones caused by fermentation resulted in faster absorption and higher bioavailability after consumption of FS. Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis. This study suggests that an isoflavone conjugate profile might be a more appropriate marker than total isoflavone levels for discriminating between the consumption of FS and NFS diets.",2020,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","['healthy adults after', 'healthy adults after fermented soybean consumption']","['fermented soybean (FS) or non-fermented soybean (NFS) consumption', 'isoflavones', 'Isoflavone metabolites']","['faster absorption and higher bioavailability', 'urinary level of total isoflavone metabolites', 'metabolite bioactivity or bioavailability', 'isoflavone bioavailability and metabolism']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0552057,"Although the urinary level of total isoflavone metabolites was similar after the consumption of the two diets, urinary genistein 7-O-sulfate was derived as a discriminant metabolite for the FS diet by partial least squares discriminant analysis.","[{'ForeName': 'Hwan-Hee', 'Initials': 'HH', 'LastName': 'Jang', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea; Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hwayoung', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heon-Woong', 'Initials': 'HW', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Su-Yeon', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Hyeon-Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Seon-Hye', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Sung-Hyen', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Gunter', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ferrari', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Scalbert', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Freisling', 'Affiliation': 'Section of Nutrition and Metabolism, International Agency for Research on Cancer (IARC-WHO), Lyon, France.'}, {'ForeName': 'Jung-Bong', 'Initials': 'JB', 'LastName': 'Kim', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea.'}, {'ForeName': 'Jeong-Sook', 'Initials': 'JS', 'LastName': 'Choe', 'Affiliation': 'National Institute of Agricultural Sciences, Rural Development Administration, Wanju, South Korea. Electronic address: swany@korea.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, South Korea. Electronic address: orank@ewha.ac.kr.'}]",Food chemistry,['10.1016/j.foodchem.2020.127317']
1293,32570015,Lactobacillus rhamnosus GG and HbA1c in middle age and older adults without type 2 diabetes mellitus: A preliminary randomized study.,"BACKGROUND AND AIMS


Probiotic supplementation improves glycemic control in persons with diabetes and the current study examined whether these benefits extend to healthy individuals.
METHODS


The current study was a 90-day placebo-controlled, double-blind, randomized clinical trial of Lactobacillus rhamnosus GG in healthy middle-aged and older adults. Fasting blood glucose and HbA1c were quantified at baseline and follow up.
RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
CONCLUSIONS


If replicated, Lactobacillus rhamnosus GG may protect against changes in glycemic control.",2020,"RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
","['middle age and older adults without type 2 diabetes mellitus', 'healthy middle-aged and older adults', 'persons with diabetes']","['placebo', 'Lactobacillus rhamnosus GG', 'Lactobacillus rhamnosus GG and HbA1c', 'Probiotic supplementation']","['glycemic control', 'HbA1c values', 'Fasting blood glucose and HbA1c']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.163147,"RESULTS


ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group.
","[{'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Sanborn', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA. Electronic address: vsanborn@kent.edu.'}, {'ForeName': 'M Andrea', 'Initials': 'MA', 'LastName': 'Azcarate-Peril', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, and UNC Microbiome Core, Center for Gastrointestinal Biology and Disease, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gunstad', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA; Brain Health Research Institute, Kent State University, USA.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.034']
1294,32571870,Long-term efficacy and safety of canakinumab in patients with colchicine-resistant familial Mediterranean fever: results from the randomised phase III CLUSTER trial.,"OBJECTIVES


To evaluate the long-term efficacy and safety of canakinumab to treat patients with colchicine-resistant familial Mediterranean fever (crFMF) during Epoch 4 (weeks 41 to 113) of the CLUSTER study.
METHODS


Patients received open-label canakinumab 150 or 300 mg, every 4 or 8 weeks during a 72-week period. We evaluated disease activity every 8 weeks using the physician global assessment (PGA) of disease activity, counting the number of flares, and measuring concentrations of C reactive protein (CRP) and serum amyloid A (SAA). Safety was studied by determination and classification of observed adverse events (AEs). We analysed safety and efficacy separately in two subgroups of patients receiving a cumulative dose of less than 2700 mg, or equal or more than 2700 mg.
RESULTS


Of the 61 patients that started the CLUSTER study, 60 entered Epoch 4 and 57 completed it. During the 72-week period, 35/60 (58.3%) patients experienced no flares, and 23/60 (38.3%) had one flare, as compared with a median of 17.5 flares per year reported at baseline. PGA scores indicated no disease activity for the majority of patients throughout the study. Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold. No new or unexpected AEs were reported.
CONCLUSION


crFMF patients treated with canakinumab during 72 weeks experienced a minimal incidence of flares and good control of clinical disease activity, with no new safety concerns reported.",2020,"Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold.","['two subgroups of patients receiving a cumulative dose of less than 2700\u2009mg, or equal or more than 2700\u2009mg', 'patients with colchicine-resistant familial Mediterranean fever (crFMF) during Epoch 4 (weeks 41 to 113) of the CLUSTER study', '61 patients that started the CLUSTER study', 'patients with colchicine-resistant familial Mediterranean fever', 'Patients received']","['canakinumab', 'open-label canakinumab']","['physician global assessment (PGA) of disease activity, counting the number of flares, and measuring concentrations of C reactive protein (CRP) and serum amyloid A (SAA', 'disease activity', 'minimal incidence of flares and good control of clinical disease activity', 'Median CRP concentrations', 'median SAA concentrations', 'safety and efficacy', 'PGA scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0459372,"Median CRP concentrations were always lower than 10 mg/L, while median SAA concentrations remained over the limit of normal (10 mg/L) but under the 30 mg/L threshold.","[{'ForeName': 'Seza', 'Initials': 'S', 'LastName': 'Ozen', 'Affiliation': 'Department of Pediatric Rheumatology, Hacettepe University, Ankara, Turkey sezaozen@gmail.com.'}, {'ForeName': 'Eldad', 'Initials': 'E', 'LastName': 'Ben-Cherit', 'Affiliation': 'Rheumatology Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Foeldvari', 'Affiliation': 'Pediatric Rheumatology, Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Amarilyo', 'Affiliation': ""Pediatric Rheumatology Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Huri', 'Initials': 'H', 'LastName': 'Ozdogan', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, University of Istanbul-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Vanderschueren', 'Affiliation': 'Clinical Department of General Internal Medicine, Research Department of Immunology, Microbiology and Transplantation, Laboratory for Clinical Infectious and Inflammatory Disorders, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marzan', 'Affiliation': ""Pediatrics Keck School of Medicine of USC, Children's Hospital Los Angeles, Los Angeles, California, USA.""}, {'ForeName': 'J Michelle', 'Initials': 'JM', 'LastName': 'Kahlenberg', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Immunology, Hepatology & Dermatology Franchise, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'De Benedetti', 'Affiliation': 'Division of Rheumatology, Ospedale Pediatrico Bambino Gesù, Roma, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Koné-Paut', 'Affiliation': 'Université de Paris Sud-Saclay, Le Kremlin Bicêtre, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217419']
1295,32574716,Stevens-Johnson Syndrome Secondary to Doxycycline Treatment in a Teenage Boy.,,2020,,[],['Doxycycline'],[],[],"[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}]",[],,0.0152077,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Morgado-Carrasco', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'González Enseñat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Prat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vicente-Villa', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España. Electronic address: avicente@sjdhospitalbarcelona.org.'}]",Actas dermo-sifiliograficas,['10.1016/j.ad.2019.02.021']
1296,32444407,Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial.,"The development of contractile muscle fatigue (CMF) affects training responses in patients with chronic obstructive pulmonary disease (COPD). Downhill walking induces CMF with lower dyspnoea and fatigue than level walking. This study compared the effect of pulmonary rehabilitation (PR) comprising downhill walking training (DT) to PR comprising level walking (conventional training (CT)) in patients with COPD.In this randomised controlled trial, 35 patients (62±8 years; forced expiratory volume in 1 s (FEV 1 ) 50±17% predicted) were randomised to DT or CT. Exercise tolerance (6-minute walk test distance (6MWD); primary outcome), muscle function, symptoms, quality-of-life and physical activity levels were assessed before and after PR. Absolute training changes and the proportion of patients exceeding the 30 m 6MWD minimally important difference (MID) were compared between groups. Quadriceps muscle biopsies were collected after PR in a subset of patients to examine physiological responses to long-term eccentric training.No between-group differences were observed in absolute 6MWD improvement (mean 6MWD change 77±46 m DT  versus  56±47 m CT; p=0.45), however 94% of patients in DT exceeded the 6MWD MID compared to 65% in CT (p=0.03). Patients in DT tended to have larger improvements than CT in other outcomes. Muscle biopsy analyses did not differ between groups.PR incorporating downhill walking confers similar magnitudes of effects to PR with conventional walking across clinical outcomes in patients with COPD, however, offers a more reliable stimulus to maximise the achievement of clinically relevant gains in functional exercise tolerance in people with COPD.",2020,"PR incorporating downhill walking confers similar magnitudes of effects to PR with conventional walking across clinical outcomes in patients with COPD, however offers a more reliable stimulus to maximise the achievement of clinically relevant gains in functional exercise tolerance in people with COPD.","['people with COPD', 'thirty five patients (62±8\u2005years; FEV 1  50±17%pred', 'patients with COPD']","['pulmonary rehabilitation (PR) comprising downhill walking training (DT) to PR comprising level walking (conventional training, CT', '6MWD Δ77±46\u2005m DT  versus  56±47', 'Downhill walking induces CMF', 'CT', 'DT or CT', 'downhill walking']","['absolute 6MWD improvement', 'Exercise tolerance (6-minute walk test distance, 6MWD [primary outcome]), muscle function, symptoms, quality-of-life and physical activity levels', 'Quadriceps muscle biopsies', '6MWD MID']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0444598', 'cui_str': 'Mid'}]",35.0,0.099033,"PR incorporating downhill walking confers similar magnitudes of effects to PR with conventional walking across clinical outcomes in patients with COPD, however offers a more reliable stimulus to maximise the achievement of clinically relevant gains in functional exercise tolerance in people with COPD.","[{'ForeName': 'Carlos Augusto', 'Initials': 'CA', 'LastName': 'Camillo', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Christian Robert', 'Initials': 'CR', 'LastName': 'Osadnik', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Burtin', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Everaerts', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Miek', 'Initials': 'M', 'LastName': 'Hornikx', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Demeyer', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Loeckx', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Fernanda Machado', 'Initials': 'FM', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Maes', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Gayan-Ramirez', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Troosters', 'Affiliation': 'Laboratory of Respiratory Diseases and Thoracic Surgery (BREATHE), Department of Chronic Diseases, Metabolism and Ageing (CHROMETA), KU Leuven, Leuven, Belgium thierry.troosters@kuleuven.be.'}]",The European respiratory journal,['10.1183/13993003.00639-2020']
1297,32448782,Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis.,"OBJECTIVES


To report the 10-year outcome of lupus nephritis (LN) treated with mycophenolate mofetil (MMF) or tacrolimus (TAC) induction in a randomised controlled trial.
METHODS


Patients with active LN were treated with MMF or TAC combined with high-dose prednisolone. Responders were switched to azathioprine (AZA) at month 6. Clinical outcomes at 10 years (renal flares, renal function decline and mortality) were assessed. Factors affecting prognosis were studied by Cox regression. Urine protein-to-creatinine ratio (uPCr) and estimated glomerular filtration rate (eGFR) at different time points were evaluated for their prediction of a poor prognosis by receiver operating characteristic (ROC) analysis.
RESULTS


150 patients were studied (age 35.5±12.8 years). Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71). AZA maintenance was given to 79% patients. After 118.2±42 months, proteinuric and nephritic renal flares occurred in 34% and 37% of the MMF, and 53% and 30% of the TAC groups of patients, respectively (p=0.49). The cumulative incidence of a composite outcome of ↓eGFR ≥30%, chronic kidney disease stage 4/5 or death at 10 years was 33% in both groups (p=0.90). Factors independently associated with a poor renal prognosis were first-time LN (HR 0.12 (0.031 to 0.39); p=0.01), eGFR (HR 0.98 (0.96 to 0.99); p=0.008) and no response at month 6 (HR 5.18 (1.40 to 19.1); p=0.01). ROC analysis revealed an uPCr >0.75 and eGFR of <80 mL/min at month 18 best predicted a poor renal prognosis.
CONCLUSIONS


Long-term data confirmed non-inferiority of TAC to MMF as induction therapy of LN. An uPCr≤0.75 and eGFR of ≥80 mL/min at month 18 best predicted a favourable 10-year outcome and may be suitable targets for induction/consolidation therapy.
TRIAL REGISTRATION NUMBER


NCT00371319.",2020,Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71).,"['150 patients were studied (age 35.5±12.8\u2009years', 'Patients with active LN', 'active lupus nephritis']","['azathioprine (AZA', 'AZA maintenance', 'MMF or TAC combined with high-dose prednisolone', 'tacrolimus with mycophenolate mofetil', 'mycophenolate mofetil (MMF) or tacrolimus (TAC']","['chronic kidney disease stage 4/5 or death', 'Clinical outcomes at 10 years (renal flares, renal function decline and mortality', 'Urine protein-to-creatinine ratio (uPCr) and estimated glomerular filtration rate (eGFR', 'eGFR', 'Complete renal response rate', 'proteinuric and nephritic renal flares', 'poor renal prognosis']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",150.0,0.119119,Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71).,"[{'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong ccmok2005@yahoo.com.'}, {'ForeName': 'Ling Yin', 'Initials': 'LY', 'LastName': 'Ho', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Shirley King Yee', 'Initials': 'SKY', 'LastName': 'Ying', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong, China.'}, {'ForeName': 'Man Chi', 'Initials': 'MC', 'LastName': 'Leung', 'Affiliation': 'Medicine, United Christian Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Chi Hung', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': 'Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Woon Leung', 'Initials': 'WL', 'LastName': 'Ng', 'Affiliation': 'Medicine, United Christian Hospital, Hong Kong, Hong Kong.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217178']
1298,32453453,Ultra-Early Blood Pressure Reduction Attenuates Hematoma Growth and Improves Outcome in Intracerebral Hemorrhage.,"OBJECTIVE


The aim was to investigate whether intensive blood pressure treatment is associated with less hematoma growth and better outcome in intracerebral hemorrhage (ICH) patients who received intravenous nicardipine treatment ≤2 hours after onset of symptoms.
METHODS


A post-hoc exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) trial was performed. This was a multicenter, international, open-label, randomized clinical trial, in which patients with primary ICH were allocated to intensive versus standard blood pressure treatment with nicardipine ≤4.5 hours after onset of symptoms. We have included 913 patients with complete imaging and follow-up data in the present analysis.
RESULTS


Among the 913 included patients, 354 (38.7%) had intravenous nicardipine treatment initiated within 2 hours. In this subgroup of patients treated within 2 hours, the frequency of ICH expansion was significantly lower in the intensive blood pressure reduction group compared with the standard treatment group (p = 0.02). Multivariable analysis showed that ultra-early intensive blood pressure treatment was associated with a decreased risk of hematoma growth (odds ratio, 0.56; 95% confidence interval [CI], 0.34-0.92; p = 0.02), higher rate of functional independence (odds ratio, 2.17; 95% CI, 1.28-3.68; p = 0.004), and good outcome (odds ratio, 1.68; 95% CI, 1.01-2.83; p = 0.048) at 90 days. Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
INTERPRETATION


In a subgroup of ICH patients with elevated blood pressure given intravenous nicardipine ≤2 hours after onset of symptoms, intensive blood pressure reduction was associated with reduced hematoma growth and improved functional outcome. ANN NEUROL 2020.",2020,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","['Intracerebral Hemorrhage', '913 patients with complete imaging and follow-up data in the present analysis', 'ICH patients who received intravenous', 'patients with primary ICH']","['intensive blood pressure treatment', 'intensive versus standard blood pressure treatment with nicardipine', 'Ultra-early Blood Pressure Reduction', 'nicardipine']","['hematoma growth and improved functional outcome', 'modified Rankin Scale score distribution', 'rate of functional independence', 'Ultra-early intensive blood pressure reduction', 'elevated blood pressure', 'risk of hematoma growth', 'frequency of ICH expansion', 'intensive blood pressure reduction']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}]",913.0,0.129574,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Warren', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St. Cloud, MN, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morotti', 'Affiliation': 'Department of Neurology and Neurorehabilitation, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Department of Medicine (Neurology), Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",Annals of neurology,['10.1002/ana.25793']
1299,32451659,Early sonographic evaluation of the placenta in cases with IUGR: a pilot study.,"PURPOSE


The objective of this study was to evaluate the feasibility and value of measuring early placental echogenicity to predict fetal intrauterine growth restriction (IUGR).
METHODS


This is a single center, retrospective cohort study. Early ultrasound examination (6 + o to 8 + 6 weeks of gestation in singleton pregnancies) was used to measure placental dimensions and placental echogenicity. A ratio between placental echogenicity and myometrial echogenicity (PE/ME-ratio) was calculated for each patient. Study population was assigned to either the IUGR group or the control group based on clinical data.
RESULTS


184 eligible pregnancies were analysed. 49 patients were included in our study. Of those, 9 (18.37%) cases were affected by IUGR and 40 (81.63%) were controls. Measuring the placental echogenicity was feasible in all cases. IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed.
CONCLUSION


Our results showed that measuring placental echogenicity is feasible in the early first trimester and demonstrated a significantly lower placental echogenicity in fetuses with subsequent IUGR. Further prospective studies are needed to validate those results.",2020,"IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed.
","['184 eligible pregnancies', 'cases with IUGR', '49 patients were included in our study']","['fetal intrauterine growth restriction (IUGR', 'IUGR']","['placental echogenicity', 'placental echogenicity and myometrial echogenicity (PE/ME-ratio', 'feasibility and value of measuring early placental echogenicity', 'placental outcomes']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",49.0,0.0319917,"IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed.
","[{'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Walter', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Böckenhoff', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Geipel', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Gembruch', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Engels', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. alexander.engels@outlook.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05601-7']
1300,32451660,Ovarian stimulation after dehydroepiandrosterone supplementation in poor ovarian reserve: a randomized clinical trial.,"OBJECTIVE


This study aimed at improving fertility rates among infertile women with poor ovarian reserve.
METHODS


This was a randomized clinical trial conducted in the outpatient clinic of a tertiary hospital. We recruited infertile women with poor ovarian reserve. The study population was divided into 2 groups, each of 25 participants. Both had induction of ovulation for three consecutive cycles. Study group took DHEA supplementation 25 mg/8 h for two consecutive cycles before induction of ovulation. Both groups were compared for outcomes of induction. Baseline ovarian reserve tests and antral follicle count (AFC) were done for both groups before induction of ovulation. The study group repeated these baseline tests after DHEA treatment to compare ovarian reserve before and after DHEA supplementation. Outcome measures were the number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection.
RESULTS


The study group baseline investigations after DHEA treatment showed a statistically significant improvement compared to the control group. The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
CONCLUSION


DHEA may help many poor responders so better considered for poor responder patients.
TRIAL REGISTRATION NUMBER


PACTR201911829230395.",2020,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
","['poor ovarian reserve', 'outpatient clinic of a tertiary hospital', 'infertile women with poor ovarian reserve']","['DHEA supplementation', 'dehydroepiandrosterone supplementation']","['Ovarian stimulation', 'Baseline ovarian reserve tests and antral follicle count (AFC', 'induction of ovulation', 'fertility rates', 'number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600225', 'cui_str': 'Vesicular ovarian follicle structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0179031', 'cui_str': 'Ampule'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.167646,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elprince', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt. prince.ma939@yahoo.com.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Kishk', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Ola M', 'Initials': 'OM', 'LastName': 'Metawie', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'Albiely', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05603-5']
1301,32462791,"Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed Spinal Cord Stimulation Programming in Subjects With Chronic Intractable Back Pain With or Without Leg Pain.","OBJECTIVE


This prospective, open-label, multicenter study evaluated the feasibility of spinal cord stimulation (SCS) therapy programming for chronic low back pain that uses multiple electrical pulsed signals (Differential Target Multiplexed).
METHODS


Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States. The subjects evaluated standard and Differential Target Multiplexed programs, each for 4 ± 1 days. A commercially available SCS trial system was used for standard SCS therapy programming. During the trialing of the multiplexed programs, implanted temporary leads were connected to an investigational external trial stimulator system.
RESULTS


Twenty subjects concluded the study. The mean baseline numeric pain rating scale (NPRS) score for low back pain was 7.4, with a mean age of 62.4 years and mean pain duration of 18.0 years. Significant relief in back pain was observed for both treatments, with significantly better response with multiplexed programming. At the end of the trial period, subjects reported a reduction in their mean NPRS score from baseline to 4.2 after standard programming and to 2.4 after Differential Target Multiplexed programming. The difference between standard and multiplexed programming was significant. The responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming. Eighty-five percent of subjects who evaluated both programming approaches preferred Differential Target Multiplexed SCS.
CONCLUSION


In this difficult-to-treat patient population, subjects reported significant reduction in chronic back pain when using multiplexed programming. A randomized clinical trial is needed to confirm the results from this feasibility study.",2020,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"['Subjects with Chronic Intractable Back Pain with or Without Leg Pain', 'Twenty subjects concluded the study', 'Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States']","['spinal cord stimulation (SCS) therapy programming', 'Differential Target Multiplexed SCS Programming']","['Responder rate for low back pain relief', 'NPRS', 'chronic back pain', 'Mean baseline numerical pain rating score (NPRS', 'back pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443199', 'cui_str': 'Differential'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",20.0,0.0338046,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Fishman', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, U.S.A.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Calodney', 'Affiliation': 'Precision Spine Care, Tyler, Texas, U.S.A.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, U.S.A.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Slezak', 'Affiliation': 'Interventional Spine Medicine, Barrington, New Hampshire, U.S.A.'}, {'ForeName': 'Ramsin', 'Initials': 'R', 'LastName': 'Benyamin', 'Affiliation': 'Millennium Pain Center, Bloomington, Illinois, U.S.A.'}, {'ForeName': 'Atiq', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Decatur Memorial Hospital, Decatur, Illinois, U.S.A.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Millennium Pain Center-Libertyville, Libertyville, Illinois, U.S.A.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Swedish Medical Center, Seattle, Washington, U.S.A.'}, {'ForeName': 'Asteghik', 'Initials': 'A', 'LastName': 'Hacobian', 'Affiliation': 'Interventional Spine Medicine, Barrington, New Hampshire, U.S.A.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Griffith', 'Affiliation': 'Precision Spine Care, Tyler, Texas, U.S.A.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Swedish Medical Center, Seattle, Washington, U.S.A.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vallejo', 'Affiliation': 'Millennium Pain Center, Bloomington, Illinois, U.S.A.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12908']
1302,32468174,Hysterectomy with uterosacral suspension or Uphold™ hysteropexy in women with apical prolapse: a parallel cohort study.,"INTRODUCTION AND HYPOTHESIS


The aim was to compare objective and subjective cure rates between Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension.
METHODS


A sample size of 49 in each arm would be required to detect a clinical difference of 20% between the groups. Owing to delayed recruitment, this originally planned randomised controlled trial was changed to a patient preference study after randomising initial 6 participants. Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included. Routine follow-up was scheduled at 6 weeks, 6 months, 12 months, and annually thereafter. Primary outcome was absence of stage ≥2 apical prolapse. Secondary outcomes included a composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes were based on quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score).
RESULTS


We recruited 50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016. Participants were followed up for a median of 25 months (23-96). Five women from the VH (10%) and 7 from the HP (14%) group were lost to follow-up. Combined anatomical and symptomatic outcomes were available for 41 (82%) VH and 39 (76%) in the HP group. There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50). We found no difference in the composite cure rate (78% VH vs 85% HP, 0.45) between the groups. There was no significant difference in surgical complications (p = 0.33), assessed using Clavien-Dindo classification. There was a 2% surgery rate for mesh exposure in the HP group.
CONCLUSIONS


Uphold™ uterine suspension and VH appear to have similar objective and subjective cure at 25 months, with no significant difference in surgical complications.",2020,There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50).,"['patient preference study after randomising initial 6 participants', 'Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included', '50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016', 'women with apical prolapse']","['Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension', 'Hysterectomy with uterosacral suspension or Uphold™ hysteropexy']","['composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes', 'objective apical outcomes; the incidence of stage 2 prolapse', 'quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score', 'absence of stage ≥2 apical prolapse', 'objective and subjective cure', 'objective and subjective cure rates', 'composite cure rate', 'surgical complications']","[{'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]","[{'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.187724,There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50).,"[{'ForeName': 'Mugdha', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia. doc.mugdha@gmail.com.'}, {'ForeName': 'Natharnia', 'Initials': 'N', 'LastName': 'Young', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'St. Vincents Clinic, UNSW Sydney Australia, Sydney, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosamilia', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia.'}]",International urogynecology journal,['10.1007/s00192-020-04328-y']
1303,32469393,"Effects of a multinutrient-fortified milk drink combined with exercise on functional performance, muscle strength, body composition, inflammation, and oxidative stress in middle-aged women: a 4-month, double-blind, placebo-controlled, randomized trial.","BACKGROUND


Multinutrient protein-enriched supplements are promoted to augment the effects of exercise on muscle mass and strength, but their effectiveness in middle-aged women, or whether there are any additional benefits to physical function, remains uncertain.
OBJECTIVES


We aimed to evaluate whether a multinutrient-fortified milk drink (MFMD) could enhance the effects of exercise on functional muscle power (stair climbing) in middle-aged women. Secondary aims were to evaluate the intervention effects on physical function, muscle strength, lean mass (LM), fat mass (FM), bone mineral content (BMC), muscle cross-sectional area (CSA), muscle density, balance, flexibility, aerobic fitness, inflammation, oxidative stress, bone and cartilage turnover, blood pressure, and blood lipids.
METHODS


In this 4-mo, double-blind, placebo-controlled, randomized trial, 244 women (45-65 y) participated in a multimodal resistance-type exercise program 3 d/wk, with random allocation to a twice-daily MFMD containing added protein, vitamin D, calcium, milk fat globule membrane (phospholipids and other bioactives), and other micronutrients (Ex + MFMD, n = 123) or an energy-matched placebo (Ex + placebo, n = 121).
RESULTS


A total of 216 women (89%) completed the study. After 4 mo, both groups experienced similar 3.6%-4.3% improvements in the primary outcomes of fast-pace 5- and 10-step stair ascent power. In contrast, Ex + MFMD experienced greater improvements in 5-step regular-pace stair descent time [net difference (95% CI): -0.09 s (-0.18, 0.00 s), P = 0.045], countermovement jump height [0.5 cm (0.04, 1.0 cm), P = 0.038], total body LM [0.3 kg (0.04, 0.60 kg), P = 0.020], FM [-0.6 kg (-1.0, -0.2 kg), P = 0.004], BMC [0.4% (0.1%, 0.6%), P = 0.020], muscle CSA [thigh: 1.8% (0.6%, 2.9%), P = 0.003; lower leg: 0.9% (0.3%, 1.6%), P = 0.005], balance eyes closed [3.3 s (1.1, 5.4 s), P = 0.005], 2-min step performance [8 steps (3, 12 steps), P = 0.003], and sit-and-reach flexibility [1.4 cm (0.6, 2.2 cm), P = 0.026]. MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover. Ex + placebo had a greater improvement in the oxidative stress marker protein carbonyls (P < 0.01).
CONCLUSIONS


In middle-aged women, daily consumption of an MFMD did not enhance the effects of a multimodal exercise program on the primary outcome of stair climbing ascent power, but did elicit greater improvements in multiple secondary outcomes including various other measures of functional performance, LM, muscle size, FM, balance, aerobic capacity, flexibility, and bone metabolism.This trial was registered at www.anzctr.org.au as ACTRN12617000383369.",2020,"MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover.","['middle-aged women', '216 women (89%) completed the study', '244 women (45-65 y) participated in a']","['multinutrient-fortified milk drink combined with exercise', 'MFMD', 'multimodal exercise program', 'multimodal resistance-type exercise program 3 d/wk, with random allocation to a twice-daily MFMD containing added protein, vitamin D, calcium, milk fat globule membrane (phospholipids and other bioactives), and other micronutrients (Ex\xa0+\xa0MFMD, n\xa0=\xa0123) or an energy-matched placebo (Ex\xa0+\xa0placebo, n\xa0=\xa0121', 'multinutrient-fortified milk drink (MFMD', 'Ex\xa0+\xa0placebo', 'placebo']","['physical function, muscle strength, lean mass (LM), fat mass (FM), bone mineral content (BMC), muscle cross-sectional area (CSA), muscle density, balance, flexibility, aerobic fitness, inflammation, oxidative stress, bone and cartilage turnover, blood pressure, and blood lipids', 'functional performance, muscle strength, body composition, inflammation, and oxidative stress', 'countermovement jump height', 'sit-and-reach flexibility', 'BMC', 'oxidative stress marker protein carbonyls', 'blood pressure, markers of inflammation, or cartilage turnover', 'functional performance, LM, muscle size, FM, balance, aerobic capacity, flexibility, and bone metabolism', 'fast-pace 5- and 10-step stair ascent power', 'total body LM', 'muscle strength, gait speed, dynamic balance, reaction time, or blood lipids', 'functional muscle power (stair climbing', '5-step regular-pace stair descent time']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517660', 'cui_str': '244'}]","[{'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",244.0,0.577968,"MFMD did not enhance the effects of exercise on any measures of muscle strength, gait speed, dynamic balance, reaction time, or blood lipids, and there was no effect of either intervention on blood pressure, markers of inflammation, or cartilage turnover.","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'De Ross', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': ""O'Connell"", 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Kruger', 'Affiliation': 'School of Health Sciences, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schollum', 'Affiliation': 'Fonterra Co-operative Group Ltd, Palmerston, North New Zealand.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gunn', 'Affiliation': 'Fonterra Co-operative Group Ltd, Palmerston, North New Zealand.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa126']
1304,32471770,The effect of diabetes education and short message service reminders on metabolic control and disease management in patients with type 2 diabetes mellitus.,"AIM


The aim of this study was to evaluate the effect of diabetes education and short message service reminders on metabolic control and disease management in patients with type 2 diabetes mellitus who were registered in a family health center and who were using oral antidiabetics.
METHODS


This pre-test and post-test control group interventional study was conducted between 2017 and 2019. For one-way analysis of variance, effect size=0.40, α=0.05 and 80% power for each group was considered to be appropriate for 48 participants. Considering probability of losses during the study, 101 patients with type-2 DM were selected to include in the study. At the beginning of the study of all the patients, metabolic (HbA1c, FBS, triglycerides, cholesterol, HDL, LDL), anthropometric (BMI), blood pressure (BP) and scales assessments were performed. The Follow-Up Form for Patients with Diabetes, Diabetes Self-Care Scale (DSCS) and World Health Organization (WHO) (5) Goodness Scale were used as data collection tools. In the study, the structured group-based education program consisting of five modules was given to the intervention group in two sessions. Immediately after the education program, short message reminders about diabetes management were sent twice a week for a six-month period to intervention group. During the study, each group was invited to the family health center to perform the third- and sixth-month evaluations. Data were analyzed by SPSS version 19. In the study, categorical variables were evaluated with Chi-squared test. The differences of the groups over time were evaluated using the Friedman test and binary comparisons of differences by Wilcoxon test. The changes among groups over time were evaluated by Mann-Whitney test.
RESULTS


In the evaluations for the third and sixth months, it was found that there was a statistically significant difference between the intervention and control groups in terms of HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001).
CONCLUSION


Diabetes education and SMS reminders sent for six months were effective in improving metabolic control and disease management in patients with type 2 diabetes mellitus.",2020,"In the evaluations for the third and sixth months, it was found that there was a statistically significant difference between the intervention and control groups in terms of HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001).
","['2017 and 2019', 'patients with type 2 diabetes mellitus who were registered in a family health center and who were using oral antidiabetics', 'patients with type 2 diabetes mellitus', '101 patients with type-2 DM']",['diabetes education and short message service reminders'],"['metabolic (HbA1c, FBS, triglycerides, cholesterol, HDL, LDL), anthropometric (BMI), blood pressure (BP) and scales assessments', 'Diabetes Self-Care Scale (DSCS) and World Health Organization (WHO', 'HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001', 'metabolic control and disease management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",101.0,0.0199426,"In the evaluations for the third and sixth months, it was found that there was a statistically significant difference between the intervention and control groups in terms of HbA1c, fasting blood sugar, lipid values (except triglycerides), blood pressure, body mass index and the scales results (p<0.001).
","[{'ForeName': 'Türkan Akyol', 'Initials': 'TA', 'LastName': 'Güner', 'Affiliation': 'Faculty of Health Sciences, Department of Social Work, Zonguldak Bulent Ecevit University, Zonguldak, Turkey. Electronic address: turkanaguner@beun.edu.tr.'}, {'ForeName': 'Gülhan', 'Initials': 'G', 'LastName': 'Coşansu', 'Affiliation': 'Istanbul University Florance Nightingale Faculty of Nursing, Public Health Nursing Department, Istanbul, Turkey. Electronic address: gulhanc@istanbul.edu.tr.'}]",Primary care diabetes,['10.1016/j.pcd.2020.04.007']
1305,32474650,Efficacy of teriparatide compared with risedronate on FRAX ® -defined major osteoporotic fractures: results of the VERO clinical trial.,"FRAX ®  calculates the 10-year probability of major osteoporotic fractures (MOF), which are considered to have a greater clinical impact than other fractures. Our results suggest that, in postmenopausal women with severe osteoporosis, those treated with teriparatide had a 60% lower risk of FRAX ® -defined MOF compared with those treated with risedronate.
INTRODUCTION


The VERO trial was an active-controlled fracture endpoint clinical trial that enrolled postmenopausal women with severe osteoporosis. After 24 months, a 52% reduction in the hazard ratio (HR) of clinical fractures was reported in patients randomized to teriparatide compared with risedronate. We examined fracture results restricted to FRAX ® -defined major osteoporotic fractures (MOF), which include clinical vertebral, hip, humerus, and forearm fractures.
METHODS


In total, 1360 postmenopausal women (mean age 72.1 years) were randomized to receive subcutaneous daily teriparatide (20 μg) or oral weekly risedronate (35 mg). Patient cumulative incidence of ≥ 1 FRAX ® -defined MOF and of all clinical fractures were estimated by Kaplan-Meier analyses, and the comparison between treatments was based on the stratified log-rank test. Additionally, an extended Cox model was used to estimate HRs at different time points. Incidence fracture rates were estimated at each 6-month interval.
RESULTS


After 24 months, 16 (2.6%) patients in the teriparatide group had ≥ 1 low trauma FRAX ® -defined MOF compared with 40 patients (6.4%) in the risedronate group (HR 0.40; 95% CI 0.23-0.68; p = 0.001). Clinical vertebral and radius fractures were the most frequent FRAX ® -defined MOF sites. The largest difference in incidence rates of both FRAX ® -defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period. There was a statistically significant reduction in fractures between groups as early as 7 months for both categories of clinical fractures analyzed.
CONCLUSION


In postmenopausal women with severe osteoporosis, treatment with teriparatide was more efficacious than risedronate, with a 60% lower risk of FRAX ® -defined MOF during the 24-month treatment period. Fracture risk was statistically significantly reduced at 7 months of treatment.
CLINICAL TRIAL INFORMATION


ClinicalTrials.gov Identifier: NCT01709110 EudraCT Number: 2012-000123-41.",2020,The largest difference in incidence rates of both FRAX ® -defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period.,"['FRAX ® -defined major osteoporotic fractures', '1360 postmenopausal women (mean age 72.1 years', 'enrolled postmenopausal women with severe osteoporosis', 'postmenopausal women with severe osteoporosis', 'major osteoporotic fractures (MOF']","['teriparatide', 'risedronate', 'subcutaneous daily teriparatide (20 μg) or oral weekly risedronate']","['low trauma FRAX ® -defined MOF', 'fractures', 'Incidence fracture rates', 'hazard ratio (HR) of clinical fractures', 'Fracture risk']","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1360.0,0.063252,The largest difference in incidence rates of both FRAX ® -defined MOF and all clinical fractures between treatments occurred during the 6- to 12-month period.,"[{'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Body', 'Affiliation': 'CHU Brugmann, Université Libre de Bruxelles (ULB), Brussels, Belgium. jean-jacques.body@chu-brugmann.be.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marin', 'Affiliation': 'Lilly Research Center Europe, Madrid, Spain.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'C A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigaçao Clínica, Sao Paulo, Brazil.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'López-Romero', 'Affiliation': 'Lilly Research Center Europe, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Möricke', 'Affiliation': 'Institut Präventive Medizin & Klinische Forschung, Magdeburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Casado', 'Affiliation': 'University Hospital Parc Taulí Sabadell, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fahrleitner-Pammer', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Stepan', 'Affiliation': 'Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'Regional Hospital, University of Orleans, Orleans, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Minisola', 'Affiliation': 'Sapienza Rome University, Rome, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Geusens', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05463-4']
1306,32479786,"Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial.","BACKGROUND


The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium.
METHODS


In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1 mg and chlorpromazine at 12·5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov, NCT03021486.
FINDINGS


Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3 [-4·4 to -2·2]), and combination group (n=10, -3·0 [-4·6 to -1·4]), with no difference among groups (p=0·71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths.
INTERPRETATION


Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group.
FUNDING


National Institute of Nursing Research.",2020,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","['patients with terminal agitation', 'patients with cancer and delirium at an acute palliative care unit', 'Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14', 'patients with cancer with terminal delirium', 'patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose']","['neuroleptic strategies', 'Neuroleptic strategies', 'haloperidol', 'intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1\u2008mg and chlorpromazine']","['mean RASS score change', 'RASS score', 'Agitation Sedation Scale (RASS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087165', 'cui_str': 'Terminal agitation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",998.0,0.653147,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'De La Rosa', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Delgado-Guay', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Arthur', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Epner', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'De La Cruz', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heung', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimberson', 'Initials': 'K', 'LastName': 'Tanco', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of Investigational Pharmacy, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, Centre for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30307-7']
1307,32479807,Short-Term Changes in Prediction Error after Cataract Surgery in Eyes Receiving 1 of 3 Types of Single-Piece Acrylic Intraocular Lenses.,"PURPOSE


To compare short-term changes in refractive prediction error (PE) after phacoemulsification among eyes receiving different types of single-piece acrylic intraocular lenses (IOLs).
DESIGN


Randomized clinical trial.
METHODS


A total of 195 eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL were randomly assigned to receive 1 of 3 IOLs: 1) an Alcon model SN60WF, 2) a Hoya model XY-1, or 3) an AMO model ZCB00V. Manifest spherical equivalent (MRSE) value, PE, and changes in PE were examined at 1 day and at 1 and 2 months postoperatively and were compared among groups.
RESULTS


The mean MRSE and PE significantly changed toward myopia between 1 day and 2 months postoperatively in all groups (P < .0001). The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P ≤ .0006). The PE change between 1 day and 2 months postoperatively was significantly smaller in the SN60WF group than in the other groups (P = .0062). IOL type and changes in anterior chamber depth and corneal curvature independently correlated with PE changes.
CONCLUSIONS


The MRSE and PE showed a significant myopic change for 2 months postoperatively in eyes implanted with 1 of 3 types of single-piece acrylic IOLs and were significantly smaller in the SN60WF than in the XY-1 and ZCB00V groups. Changes in PE during the 2 postoperative months were smaller in the SN60WF IOLs than in the other IOLs, suggesting that postoperative refractive stability differs among single-piece acrylic IOLs.",2020,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","['One-hundred ninety-five eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL', 'eyes receiving different types of single-piece acrylic intraocular lenses (IOLs']",['SN60WF'],"['PE change', 'IOL type, and changes in anterior chamber depth and corneal curvature', 'mean MRSE and PE', 'MRSE and PE', 'AMO ZCB00V. Manifest spherical equivalent value (MRSE), PE, and changes in PE', 'refractive prediction error (PE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",195.0,0.0496226,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan. Electronic address: hayashi-ken@hayashi.or.jp.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Hayashi', 'Affiliation': 'Department of Ophthalmology, National Hospital Organization Saitama Hospital, Saitama, Japan; Department of Ophthalmology, Keio University Faculty of Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.05.031']
1308,32584714,Comparing open reduction and internal fixation versus closed reduction using dual-point distraction and percutaneous fixation for treating calcaneal fractures.,"OBJECTIVES


This study aims to compare the early clinical, functional and radiographic outcomes of a small cohort of patients with calcaneal fractures treated with closed reduction using a dual- point distraction system and the traditional lateral approach.
PATIENTS AND METHODS


We prospectively treated 40 patients with calcaneus fractures who presented to our emergency department between January 2017 and February 2018. In total, 35 patients (22 males, 13 females; median age 39.8 years; range, 19 to 57 years) were included in this study since five patients were not followed up. Fractures were classified according to the Sanders classification system using computer tomography images. Clinical outcomes including postoperative two-week visual analog scale (VAS) score, sickness absence period, operating time and complication rate were recorded.
RESULTS


The mean follow-up period was 24 months. Closed reduction using dual-point distraction and percutaneous fixation (group 1) was performed in 17 patients, whereas the extended lateral approach (group 2) was used in 18 patients. There were no significant differences between both groups in age, follow- up outcomes and Sanders classification. Operating time was significantly shorter in group 1 than in group 2. At postoperative two weeks, VAS scores were significantly lower in group 1 than in group 2. The complication rate and sickness absence period were significantly lower in group 1 than in group 2.
CONCLUSION


Closed reduction using dual-point distraction can be preferred owing to many advantages including considerably decreased risk of wound complications, sickness absence period and length of hospital stay as well as superior postoperative rehabilitation with a low pain score.",2020,Operating time was significantly shorter in group 1 than in group 2.,"['35 patients (22 males, 13 females; median age 39.8 years; range, 19 to 57 years', 'We prospectively treated 40 patients with calcaneus fractures who presented to our emergency department between January 2017 and February 2018', 'patients with calcaneal fractures treated with']","['internal fixation versus closed reduction using dual-point distraction and percutaneous fixation', 'Closed reduction using dual-point distraction and percutaneous fixation', 'closed reduction using a dual- point distraction system and the traditional lateral approach']","['complication rate and sickness absence period', 'postoperative two-week visual analog scale (VAS) score, sickness absence period, operating time and complication rate', 'risk of wound complications, sickness absence period and length of hospital stay', 'Operating time', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0281926', 'cui_str': 'Fracture of calcaneus'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441551', 'cui_str': 'Percutaneous fixation of bone'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",5.0,0.0164485,Operating time was significantly shorter in group 1 than in group 2.,"[{'ForeName': 'Sefa Giray', 'Initials': 'SG', 'LastName': 'Batıbay', 'Affiliation': ''}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bayram', 'Affiliation': 'İstanbul Üniversitesi İstanbul Tıp Fakültesi Ortopedi ve Travmatoloji Anabilim Dalı, 34093 Çapa, Fatih, İstanbul, Türkiye. dr.serkanbayram89@gmail.com.'}]",Joint diseases and related surgery,['10.5606/ehc.2020.72236']
1309,32590251,The treatment of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation.,"OBJECTIVES


To compare the advantages and disadvantages of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO) with those of semilunar ganglion RF thermocoagulation (GRF) under local anesthesia, for exploring a new and available surgical method for patients with V2 + V3 idiopathic trigeminal neuralgia.
PATIENTS AND METHODS


102 patients with V2 + V3 idiopathic trigeminal neuralgia were enrolled in this prospective randomized controlled clinical trial, and they were divided into the PRF and GRF group randomly (n = 51 in both groups). The outcome of pain relief was assessed using the Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed). Recurrence was defined as a relapse to a previous lower level after attainment of any higher level of pain relief. The immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications were observed and recorded.
RESULTS


Their basic conditions (age, gender ratio, side of pain, and disease duration) were similar. Furthermore, we found that the 2-year postoperative effective rate between them had no significant difference. By comparing the two groups, PRF group had the better immediate effective rate of the V2 branch and no severe complications such as corneal ulcer, however, GRF group had lower 2-year postoperative recurrence rate of the V3 branch and fewer facial swelling.
CONCLUSION


The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.",2020,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","['patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia', '102 patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia']","['PRF and GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation', 'semilunar ganglion RF thermocoagulation (GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO']","['facial swelling', 'pain relief', 'Recurrence', 'immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications', '2-year postoperative effective rate', 'immediate effective rate of the V2 branch and no severe complications such as corneal ulcer', 'Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed', '2-year postoperative recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}]","[{'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0017067', 'cui_str': 'Structure of nervous system ganglion'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}, {'cui': 'C0016521', 'cui_str': 'Structure of foramen ovale of heart'}, {'cui': 'C0040995', 'cui_str': 'Structure of trigeminal ganglion'}]","[{'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010043', 'cui_str': 'Corneal ulcer'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",102.0,0.0255936,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': ""Department of Pain Clinic, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Changxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Pain Clinic, Subei People's Hospital, Yangzhou, Jiangsu, 225002, People's Republic of China. Electronic address: 1714452550@qq.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China. Electronic address: zy830226@163.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106025']
1310,32593791,Differential effects of modafinil on performance of low-performing and high-performing individuals during total sleep deprivation.,"BACKGROUND


Individual responses to the effects of inadequate sleep have been well documented; some people are more vulnerable to the effects of sleep loss than others. Fatigue-vulnerable individuals generally require access to effective fatigue countermeasures; however, the question arises as to whether these fatigue-vulnerable individuals receive the same benefits shown in group efficacy data. The present study administered modafinil to individuals to determine its differential effects on performance of best and worst performers during sleep deprivation.
METHODS


A sample of 22 men, age 21-40 yrs., was tested on 2 separate occasions during which they were kept awake for 36 h. During one period they received 200 mg modafinil; during the other they received placebo. Participants were tested on a variety of tasks while rested and at 5-hr intervals across the continuous wakefulness period. Performance for each cognitive task and subjective measure of fatigue from the placebo period was used to group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task.
RESULTS


Results indicated that on the MTS task, the HP group performed the same throughout the testing period, regardless of whether they received modafinil or not. However, the LP group significantly improved after receiving modafinil compared to placebo. Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo. Performance on the RDM showed no difference between groups, regardless of drug condition. Groups did not differ after receiving modafinil on subjective fatigue measured by the POMS.
CONCLUSIONS


Depending on the task, HP individuals did not benefit substantially when administered modafinil compared to placebo. However, the LP individuals improved after receiving modafinil compared to placebo.",2020,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","['low-performing and high-performing individuals during total sleep deprivation', 'group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task', 'A sample of 22 men, age 21-40\u202fyrs., was tested on 2 separate occasions during which they were kept awake for 36\u202fh']","['modafinil', '200\u202fmg modafinil', 'placebo']","['subjective fatigue', 'lapses', 'number of lapses']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.090569,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","[{'ForeName': 'J Lynn', 'Initials': 'JL', 'LastName': 'Caldwell', 'Affiliation': 'Naval Medical Research Unit Dayton, United States of America. Electronic address: jo.caldwell@us.af.mil.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Schroeder', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Kunkle', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Henry G', 'Initials': 'HG', 'LastName': 'Stephenson', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172968']
1311,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
1312,32600393,Stress ulcer prophylaxis versus placebo-a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD).,"BACKGROUND


Critically ill infants with congenital heart disease (CHD) are often prescribed stress ulcer prophylaxis (SUP) to prevent upper gastrointestinal bleeding, despite the low incidence of stress ulcers and limited data on the safety and efficacy of SUP in infants. Recently, SUP has been associated with an increased incidence of hospital-acquired infections, community-acquired pneumonia, and necrotizing enterocolitis. The objective of this pilot study is to investigate the feasibility of performing a randomized controlled trial to assess the safety and efficacy of withholding SUP in infants with congenital heart disease admitted to the cardiac intensive care unit.
METHODS


A single center, prospective, double-blinded, randomized placebo-controlled pilot feasibility trial will be performed in infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for > 24 h. Patients will be randomized to receive a histamine-2 receptor antagonist (H2RA) or placebo until they are discontinued from respiratory support. Randomization will be performed within 2 strata defined by admission type (medical or surgical) and age (neonate, age < 30 days, or infant, 1 month to 1 year). Allocation will be a 1:1 ratio using permuted blocks to ensure balanced allocations across the two treatment groups within each stratum. The primary outcomes include feasibility of screening, consent, timely allocation of study drug, and protocol adherence. The primary safety outcome is the rate of clinically significant upper gastrointestinal bleeding. The secondary outcomes are the difference in the relative and absolute abundance of the gut microbiota and functional microbial profiles between the two study groups. We plan to enroll 100 patients in this pilot study.
DISCUSSION


Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects. The role of SUP in infants with CHD has not been examined, and there is equipoise on the risks and benefits of withholding this therapy. In addition, this therapy has been discontinued in other neonatal populations due to the concern for hospital-acquired infections and necrotizing enterocolitis. Furthermore, exploring changes to the microbiome after exposure to SUP may highlight the mechanisms by which SUP impacts potential microbial dysbiosis of the gut and its association with hospital-acquired infections. Assessment of the feasibility of a trial of withholding SUP in critically ill infants with CHD will facilitate planning of a larger multicenter trial of safety and efficacy of SUP in this vulnerable population.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03667703. Registered 12 September 2018, https://clinicaltrials.gov/ct2/show/NCT03667703?term=SUPPRESS+CHD&draw=2&rank=1 . All WHO Trial Registration Data Set Criteria are met in this manuscript.",2020,"DISCUSSION


Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects.","['ill infants with congenital heart disease (CHD', 'critically ill infants with CHD', '100 patients in this pilot study', 'infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for ', 'infants with congenital heart disease admitted to the cardiac intensive care unit', 'infants with CHD', 'critically ill infants with congenital heart disease (SUPPRESS-CHD']","['histamine-2 receptor antagonist (H2RA) or placebo', 'SUP', 'withholding SUP', 'placebo']","['feasibility of screening, consent, timely allocation of study drug, and protocol adherence', 'safety and efficacy', 'rate of clinically significant upper gastrointestinal bleeding', 'relative and absolute abundance of the gut microbiota and functional microbial profiles']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C0019593', 'cui_str': 'Histamine H2 receptor antagonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0400807', 'cui_str': 'Stress ulcer of stomach'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.374185,"DISCUSSION


Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects.","[{'ForeName': 'Kimberly I', 'Initials': 'KI', 'LastName': 'Mills', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Ben D', 'Initials': 'BD', 'LastName': 'Albert', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Bechard', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Kaza', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Rakoff-Nahoum', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hera', 'Initials': 'H', 'LastName': 'Vlamakis', 'Affiliation': 'Broad Institute of MIT and Harvard, Boston, MA, USA.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Priebe', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nilesh M', 'Initials': 'NM', 'LastName': 'Mehta', 'Affiliation': 'Harvard Medical School, Boston, MA, USA. nilesh.mehta@childrens.harvard.edu.'}]",Trials,['10.1186/s13063-020-04513-w']
1313,32598447,"Effects of Prophylactic Lipofilling After Radiotherapy Compared to Non-Fat Injected Breasts: A Randomized, Objective Study.","BACKGROUND


Patients who are suffering from invasive breast cancer may require post-mastectomy radiation therapy (PMRT). PMRT improves outcomes in breast cancer patients in terms of locoregional recurrence. Preliminary studies indicate that fat injections reduce post-radiation damage of soft tissue and implants.
OBJECTIVES


The aim of this study was to demonstrate the safety and effectiveness of prophylactic fat injections on radiated implanted breasts.
METHODS


The authors randomly assigned 60 female patients to either Group A or B. Group A patients received 3 breast fat injections, according to Coleman's technique, after radiotherapy and before expander removal with definitive implant insertion. Group B patients underwent surgery without lipofilling. At each surgical operation, skin biopsies were performed in a specific breast area to evaluate adipose tissue thickness, and a statistical analysis of the thickness variations was performed with the Wilcoxon's sum test. Disability was assessed according to the Late Effects of Normal Tissues-Subjective Objective Management Analytic scale.
RESULTS


The study demonstrates a qualitative and quantitative improvement about tissues after fat injection. This is highlighted by the significant increase in thickness after lipofilling.
CONCLUSIONS


The study, which is based on both clinical and histological findings and is supported by the comparison of a control group with a 1-year follow-up, demonstrates that fat injections reduce tissue radio damage, improving reconstructive surgery outcomes and quality of life.
LEVEL OF EVIDENCE: 2


",2020,PMRT improves outcomes in breast cancer patients in terms of locoregional recurrence.,"['breast cancer patients', 'Patients who suffering by invasive breast cancer', 'Sixty female patients']","[""three breast fat injections, according to Coleman's technique, after radiotherapy and before expander removal with definitive implant insertion"", 'Prophylactic Lipofilling', 'prophylactic fat injections', 'mastectomy radiation therapy (PMRT', 'surgery without lipofilling', 'PMRT', 'Radiotherapy']","['safety and effectiveness', 'Disability', 'locoregional recurrence', 'reconstructive surgery outcomes and quality of life']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0221428,PMRT improves outcomes in breast cancer patients in terms of locoregional recurrence.,"[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Gentilucci', 'Affiliation': 'Department of Plastic Surgery, University of Perugia, San Sisto Perugia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mazzocchi', 'Affiliation': 'Department of Plastic Surgery, University of Perugia, San Sisto Perugia, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Alfano', 'Affiliation': 'Department of Plastic Surgery, University of Perugia, San Sisto Perugia, Italy.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa182']
1314,32598629,[Glycemia normalization in patients with obesity and type 2 diabetes mellitus: bariatric surgery vs pharmacological therapy].,"AIMS


To compare glucose - lowering and weight reduction capacity of bypass operations (gastric bypass (GB), biliopancreatic diversion (BPD) vs GLP-1 agonist liraglutide 3.0 mg (models of maximum incretin effect) for 6 months.
MATERIALS AND METHODS


46 patients with type 2 diabetes and long history (≥10 years) of obesity were divided into 2 groups: surgery - group (n=23) and liraglutide - group (n=23), where liraglutide 3.0 mg in dose - escalation manner was added to baseline glucose - lowering therapy. Anthropometric parameters, HbA1c and insulin resistance (IR) by hyperinsulinemic euglycemic clamp (M-value) were measured before and 16 weeks after the intervention. With the stabilization of glycemia (≤6.5 mmol/l at fasting state, ≤8 mmol/l postprandial) the initial glucose - lowering therapy was canceled.
RESULTS AND DISCUSSION


Both surgery and liraglutide 3.0 mg provided target HbA1c in 16 weeks. Bypass operations led to elimination of glucose - lowering therapy in 82.6% patients due to a more significant weight reduction and decrease in IR. In liraglutide - group previous glucose - lowering therapy was cancelled in 78.3% patients, mainly receiving baseline mono - and two - component therapy. The most significant difference between interventions was achieved in BMI (-8.9 kg in surgery group vs -3.8 kg in liraglutide group, p.",2019,Bypass operations led to elimination of glucose - lowering therapy in 82.6% patients due to a more significant weight reduction and decrease in IR.,"['patients with obesity and type 2 diabetes mellitus', '46 patients with type 2 diabetes and long history (≥10 years) of obesity']","['liraglutide - group', 'liraglutide - group previous glucose - lowering therapy', 'liraglutide 3.0 mg in dose - escalation manner was added to baseline glucose - lowering therapy', 'liraglutide', 'GLP-1 agonist liraglutide', 'bypass operations (gastric bypass (GB), biliopancreatic diversion (BPD']","['Anthropometric parameters, HbA1c and insulin resistance (IR) by hyperinsulinemic euglycemic clamp (M-value', 'BMI', 'IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",46.0,0.0154823,Bypass operations led to elimination of glucose - lowering therapy in 82.6% patients due to a more significant weight reduction and decrease in IR.,"[{'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Sklyanik', 'Affiliation': 'Endocrinology Research Centre.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Shestakova', 'Affiliation': 'Endocrinology Research Centre.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Yurasov', 'Affiliation': 'Central Clinical Hospital No. 1 of Russian Railways.'}, {'ForeName': 'Y I', 'Initials': 'YI', 'LastName': 'Yashkov', 'Affiliation': 'Center of Endosurgery and Lithotripsy.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Shestakova', 'Affiliation': 'Endocrinology Research Centre.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.10.000375']
1315,32598793,[Evaluation of the effectiveness of ARVI treatment regimen including etiotropic (enisamium iodide) and symptomatic treatment].,"AIM


To assess the effectiveness of the use of the antiviral drug enisamium iodide in the complex treatment of acute respiratory viral infections (ARVI) caused by various pathogens in routine clinical practice.
MATERIALS AND METHODS


А prospective randomized study included 134 patients who were treated in the epidemic season of influenza and ARVI in 20182019. All patients were examined for the presence of influenza A and B viruses, respiratory syncytial virus, human metapneumovirus, parainfluenza virus, coronaviruses, rhinoviruses, adenoviruses in nasopharyngeal swabs by PCR. Patients of the main group received enisamium iodide along with symptomatic therapy, the control group received only symptomatic therapy. The primary parameter of the effectiveness of therapy was evaluated on the scale of the general severity of the manifestations of ARVI (Total Symptom Score TSS) from the 2nd to the 4th day and by the secondary criteria of effectiveness: assessment of the duration of ARVI, the severity of fever, the proportion of patients with normal body temperature, the duration of the main clinical symptoms of acute respiratory viral infections, the proportion of patients in whom complications requiring antibiotics were noted, the dynamics of interferon status on the 6th day. To conduct a statistical analysis, depending on the efficiency parameter, the ANCOVA method with a fixed group factor and an initial score on the TSS severity scale was used as covariates, a criterion for comparing quantitative indicators in two independent groups.
RESULTS


According to the results of the analysis of the primary efficacy parameter, the median (interquartile range) of the average score on the scale of the general severity of ARVI manifestations in the main group was 4.33 (3.675.83), in the comparison group 6.00 (4.677.25; p0.001). The duration of systemic and local manifestations of acute respiratory viral infections was statistically significantly less in the main group (p=0.002 and p=0.019, respectively). Prescription of additional therapy was required in 2 (2.9%) patients of the main group (patients taking enisamium iodide), compared with 8 (11.9%) patients in the control group. Serum levels of interferon  and interferon  on the last day of treatment were statistically significantly higher in patients of the main group compared with the control group (p0.001). Treatment (excellent) was evaluated by 42 (62.7%) patients, while in the control group only 17 (25.8%) patients gave similar ratings. Both patients (p0.001) and doctors (p0.002) rated therapy tolerance better in the study group.
CONCLUSION


The results confirmed the safety and effectiveness of enisamium iodide as a treatment for ARVI and influenza. The antiviral, interferonogenic and anti-inflammatory properties of the drug are involved in the formation of an antiviral response and reduce the risk of complications, which makes it possible to reduce the number of symptomatic agents used.",2020,"Both patients (p0.001) and doctors (p0.002) rated therapy tolerance better in the study group.
","['134 patients who were treated in the epidemic season of influenza and ARVI in 20182019', 'acute respiratory viral infections (ARVI']","['enisamium iodide along with symptomatic therapy, the control group received only symptomatic therapy', 'ARVI']","['safety and effectiveness', 'duration of ARVI, the severity of fever', 'general severity of the manifestations of ARVI (Total Symptom Score TSS', 'therapy tolerance', 'TSS severity scale', 'duration of systemic and local manifestations of acute respiratory viral infections', 'general severity of ARVI manifestations', 'Serum levels of interferon \uf0e1 and interferon \uf0e3']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}]","[{'cui': 'C2983877', 'cui_str': 'enisamium iodide'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600327', 'cui_str': 'Toxic shock syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]",134.0,0.0236385,"Both patients (p0.001) and doctors (p0.002) rated therapy tolerance better in the study group.
","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Lioznov', 'Affiliation': 'Smorodintcev Research Institute of Influenza.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Karnaukhova', 'Affiliation': 'Pavlov First Saint Petersburg State Medical University.'}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Zubkova', 'Affiliation': 'Smorodintcev Research Institute of Influenza.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Shakhlanskaya', 'Affiliation': 'Smorodintcev Research Institute of Influenza.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.03.000572']
1316,32598808,[Preprocedural high - sensitivity C-reactive protein (hsCRP) decrease during intensive atorvastatin therapy: the presumable impact on atherosclerosis progression after coronary stenting].,"Proinflammatory status is the risk factor for coronary atherosclerosis progression after coronary stenting (CS). Intensive statin treatment is associated with hsCRP concentration decline.
AIM


to evaluate prognostic significance of preprocedural hsCRP level reduction with intensive statin regimen for coronary atherosclerosis progression during one year after CS.
MATERIALS AND METHODS


We enrolled 102 patients with stable angina who were on list for scheduled CS. Group I (n=37) patients received atorvastatin 80 mg for 7 days before and 3 months after CS with further dose adjustment according to LDL; group II (n=65) patients received atorvastatin 20-40 mg/day for LDL goal achievement. HsCRP level was assessed at baseline, before CS and after 1, 3, 6 and 12 months. Coronary atherosclerosis progression was defined as new ≥50% stenosis or ≥30% increase of ≥20% pre - existing stenosis according to coronary angiography (CA) 1 year after CS.
RESULTS


Baseline concentration of hsCRP was comparable: 0.21 (0.13; 0.38) vs. 0.20 (0.1; 0.44) mg/dl in groups I and II, respectively (p>0.05). In group I significant hsCRP level decrease to 0.14 (0.07; 0.32) mg/dl (p.",2019,In group I significant hsCRP level decrease to 0.14 (0.07; 0.32),"['We enrolled 102 patients with stable angina who were on list for scheduled CS', 'coronary atherosclerosis progression after coronary stenting (CS', 'coronary atherosclerosis progression during one year after CS']","['atorvastatin', 'atorvastatin therapy', 'atorvastatin 20-40 mg/day for LDL goal achievement', 'intensive statin regimen']","['Coronary atherosclerosis progression', 'HsCRP level', 'atherosclerosis progression', 'hsCRP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",102.0,0.0230838,In group I significant hsCRP level decrease to 0.14 (0.07; 0.32),"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Shchinova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Shlevkova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Filatova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Potekhina', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Osokina', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Romasov', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Zharova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Noeva', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Samko', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Masenko', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Arefieva', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Provatorov', 'Affiliation': 'National Medical Research Center of Cardiology.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000144']
1317,32598809,[Exercise training and erectile dysfunction in patients after coronary artery bypass grafting].,"AIM


to estimate the effects of exercise training on erectile function after coronary artery bypass grafting.
MATERIALS AND METHODS


114 men with stable coronary artery disease undergoing on - pump coronary artery bypass grafting were examined. Patients with ED were randomized into two groups comparable in the main demographic, clinical and baseline parameters: a group of patients undergoing supervised exercise trainings at the outpatient rehabilitation center (n=53) and a group of patients without any exercise trainings at the outpatient hospital (n=61). Patients were assessed 1, 6 and 12 months after CABG. All patients underwent echocardiography (ECHO-CG), bicycle ergometer test without discontinuation of the drug therapy, measurement of nocturnal penile tumescence (NPT), ultrasound assessment of the cavernous arteries with the further estimation of their endothelial function.
RESULTS


In addition to the expected improvements in exercise tolerance, regular cycling exercises led to a significant recovery of erectile function (number and duration of NTP, increased penile blood flow volume, estimated during NTP measurement), improved endothelial function of the cavernous arteries, compared to patients without exercise trainings. However, the obtained effects in the group with exercise trainings were short - term. One year after CABG, the number of NTP and penile blood flow volume were superior in patients undergoing exercise trainings. Differences in other parameters became less reliable between the groups.
CONCLUSION


Aerobic exercise trainings appeared to be effective for optimizing exercise tolerance, erectile and endothelial function, and allow improving the prognosis of these patients and, therefore, are needed to be included in the rehabilitation programs for patients undergoing CABG.",2019,"One year after CABG, the number of NTP and penile blood flow volume were superior in patients undergoing exercise trainings.","['Patients with ED', '114 men with stable coronary artery disease undergoing on - pump coronary artery bypass grafting were examined', 'patients undergoing CABG', 'patients after coronary artery bypass grafting']","['exercise training', 'Aerobic exercise trainings', 'echocardiography (ECHO-CG), bicycle ergometer test without discontinuation of the drug therapy, measurement of nocturnal penile tumescence (NPT), ultrasound assessment of the cavernous arteries with the further estimation of their endothelial function', 'Exercise training', 'supervised exercise trainings at the outpatient rehabilitation center (n=53) and a group of patients without any exercise trainings']","['exercise tolerance, erectile and endothelial function', 'erectile function (number and duration of NTP, increased penile blood flow volume', 'erectile function', 'number of NTP and penile blood flow volume', 'endothelial function of the cavernous arteries']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0372464', 'cui_str': 'Nocturnal penile tumescence'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205201', 'cui_str': 'Cavernous'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205201', 'cui_str': 'Cavernous'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",114.0,0.0235409,"One year after CABG, the number of NTP and penile blood flow volume were superior in patients undergoing exercise trainings.","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Pomeshkina', 'Affiliation': 'Research Institute for Complex Issues of Cardiovascular Diseases.'}, {'ForeName': 'O L', 'Initials': 'OL', 'LastName': 'Barbarash', 'Affiliation': 'Research Institute for Complex Issues of Cardiovascular Diseases.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Pomeshkin', 'Affiliation': 'Kemerovo State Medical University.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000149']
1318,32442746,The effect of mirror therapy after carpal tunnel syndrome surgery: A randomised controlled study.,"The aim of this randomised controlled study was to investigate the effectiveness of mirror therapy (MT) on carpal tunnel syndrome (CTS) patients' symptoms and hand function after surgery. The patients' hand function was evaluated using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Nine Hole Peg Test. Their pain was evaluated using a visual analog scale, and their sensitivity was evaluated using the Semmes-Weinstein monofilament test before surgery, and at 3 and 6 weeks post-surgery. Thirty-five patients between the ages of 25 and 60 years were included in the study. In the control group (CTG) (n=17), the conventional physiotherapy program was applied for 4 weeks after 2 weeks of immobilisation. In addition to conventional physiotherapy, the MT group (MTG) (n=18) did MT during the immobilisation period. There were no statistically significant differences between the groups' demographic and clinical characteristics before treatment (P˃0.05). After treatment, all parameters improved in both groups. MTG had statistically lower pain at rest (P=0.004) and night-time pain (P=0.037) in the 3rd week, but there were no statistically significant differences between the other parameters and scores between the groups (P˃0.05). The study indicates improvement in the parameters due to the early introduction of MT after CTS surgery, but once conventional methods were started after immobilisation, there were no significant differences between groups. However, the MT had reduced pain and improved sensation and function. Both groups experienced positive effects of the surgical treatment and the physiotherapy in the 6th postoperative week.",2020,MTG had statistically lower pain at rest (p=0.004) and nighttime pain (p=0.037) in the 3 rd  week.,"[""carpal tunnel syndrome (CTS) patients' symptoms and hand function after surgery"", 'Thirty-five patients between the ages of 25 and 60 years were included in the study', 'carpal tunnel syndrome surgery']","['conventional physiotherapy program', 'mirror therapy (MT', 'mirror therapy', 'conventional physiotherapy, the MT group (MTG']","['pain and improved sensation and function', 'nighttime pain', 'Boston Carpal Tunnel Syndrome Questionnaire (BCTQ', 'pain']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",35.0,0.0252547,MTG had statistically lower pain at rest (p=0.004) and nighttime pain (p=0.037) in the 3 rd  week.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Civi Karaaslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece Yerleşkesi Alkent 2000 Mh. Yiğittürk Cd. No:5/9/1 34500 İstanbul, Turkey. Electronic address: tugba.civi@istanbul.edu.tr.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Berkoz', 'Affiliation': 'Hand Surgery Unit, Department of Plastic, Reconstructive and Aesthetic Surgery, Topkapı, Turgut Özal Millet Cd, 34093 Fatih/İstanbul, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece Yerleşkesi Alkent 2000 Mh. Yiğittürk Cd. No:5/9/1 34500 İstanbul, Turkey.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.04.011']
1319,32443981,"Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).","BACKGROUND


Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
METHODS


This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI.
DISCUSSION


The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages.
TRIAL REGISTRATION


The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.",2020,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","['people with progressive MS (PMS', 'people with progressive multiple sclerosis', 'Three hundred and sixty subjects from 11 sites', 'people with PMS who have cognitive impairment', '6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages', 'people with relapsing-remitting MS without cognitive impairment', 'people with progressive forms of the disease who have objectively identified cognitive impairment']","['cognitive rehabilitation and aerobic exercise (COGEx', 'cognitive rehabilitation (CR) and aerobic exercise (EX', 'CR and aerobic exercise', 'CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise']","[' indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI', 'Symbol Digit Modalities Test (SDMT) measuring PS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",,0.510419,"We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques.
","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Amato', 'Affiliation': 'Department NEUROFARBA, Section Neurosciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Brichetto', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Via Operai 40, 16149, Genoa, Italy.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square MS Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Section for Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, DK-8000, Aarhus, Denmark. dalgas@ph.au.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, East Hanover, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health: Medicine, Dentistry and Human Sciences, University of Plymouth, Devon, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Maria Assunta', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, and Neurology unit, IRCCS, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC neurology,['10.1186/s12883-020-01772-7']
1320,32444994,"""BAX602"" in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial.","BACKGROUND


The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure.
METHODS AND DESIGN


This investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2-12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5).
ETHICS AND DISSEMINATION


The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals.
TRIAL REGISTRATION


The trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020.",2020,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"['Refractory Congestive Heart Failure', '30 patients', 'patients undergoing']","['Extracorporeal Ventricular Assist Device Implantation', 'BAX602 spray', 'BAX602', 'extracorporeal ventricular assist device implantation surgery']","['safety and effectiveness', 'severity of adhesions, which will be evaluated during re-sternotomy surgery', 'adhesion severity']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.202345,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"[{'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Fukushima', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan. s.fukushima@ncvc.go.jp.'}, {'ForeName': 'Koko', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'The Biostatistics Center and Department of Biostatistics and Bioinformatics, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Onda', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shiose', 'Affiliation': 'Department of Cardiovascular Surgery, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiac Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Norihide', 'Initials': 'N', 'LastName': 'Fukushima', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-06990-2']
1321,32445670,Long-term safety and efficacy of subcutaneous C1-inhibitor in older patients with hereditary angioedema.,"BACKGROUND


Patients aged 65 years and older with hereditary angioedema (HAE) owing to C1-inhibitor (C1-INH) deficiency may have an altered response to treatment and are at higher risk for treatment-related adverse events (AEs) because of comorbidities and polypharmacy.
OBJECTIVE


To investigate the safety and efficacy of subcutaneous C1 esterase inhibitor (C1-INH) in patients aged 65 years and older treated in an open-label extension of a phase 3 trial.
METHODS


Eligible patients (≥4 attacks for more than 2 consecutive months) were randomized to receive twice-weekly subcutaneous C1-INH with a dosage of 40 IU/kg or 60 IU/kg for 52 to 140 weeks. Safety end points and efficacy outcomes were evaluated for patients aged 65 years and above and younger than 65 years.
RESULTS


Of the 126 patients treated, 10 were 65 years and older (mean age [range], 68 [65-72 years]). A total of 8 of 10 patients had multiple comorbidities, and 6 of these 10 patients were taking more than 5 non-HAE-related drugs concomitantly. AEs occurring in more than 1 patient included injection site bruising (n = 2, related), injection site pain (n = 2, related), urinary tract infection (n = 2, unrelated), and diarrhea (n = 2, unrelated). No thromboembolic events or cases of anaphylaxis were reported. Two patients aged 65 years and older experienced unrelated serious AEs (dehydration and hypokalemia in 1 and pneumonia and an HAE attack leading to hospitalization in another). A total of 6 of 9 evaluable patients were responders, with a greater than or equal to 50% reduction in HAE attacks vs prestudy; 6 of 10 patients had less than 1 attack over 4 weeks and 3 were attack-free (median attack rate, 0.52 attacks per month).
CONCLUSION


Subcutaneous C1-INH was well-tolerated and effective in the management of HAE in patients aged 65 years and older with multiple comorbid conditions and polypharmacy.",2020,No thromboembolic events or cases of anaphylaxis were reported.,"['126 subjects treated', 'Patients ≥65 years old with hereditary angioedema (HAE', 'Eligible patients (≥4 attacks over 2 consecutive months', 'patients ≥65 years old treated in an open-label extension of a phase 3 trial', 'Two subjects ≥65 years old experienced unrelated serious AEs (dehydration and hypokalemia in one and pneumonia and an HAE attack leading to hospitalization in another', 'patients aged ≥65 and <65 years', 'Older Patients With Hereditary Angioedema', 'subjects ≥65 years old with multiple comorbid conditions and polypharmacy', 'Eight of 10 subjects had multiple comorbidities; 6/10 were taking >5 non-HAE-related drugs concomitantly', ' 10 were ≥65 years old (mean age [range], 68 [65-72 years']","['Subcutaneous C1-Inhibitor', 'C1-INH (SC', 'subcutaneous (SC) C1-INH']","['Safety endpoints and efficacy outcomes', 'tolerated and effective', 'urinary tract infection', 'safety and efficacy', 'thromboembolic events', 'HAE attacks']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}]",,0.0321857,No thromboembolic events or cases of anaphylaxis were reported.,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Allergy Section, Division of Immunology, Department of Internal Medicine, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio. Electronic address: jonathan.bernstein@uc.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation and University of Ottawa Medical School, Ottawa, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Baker Allergy, Asthma, and Dermatology Research Center, Portland, Oregon.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Bygum', 'Affiliation': 'Hereditary Angioedema Centre Denmark, Department of Dermatology, and Allergy Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring, King of Prussia, Pennsylvania.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.015']
1322,32446752,Adding Financial Incentives to Online Group-Based Behavioral Weight Control: An RCT.,"INTRODUCTION


Internet-delivered behavioral weight control is promising for expanding the reach and availability of weight management, but online programs produce lower weight losses than typically achieved in person. Financial incentives have been shown to increase weight losses. This study examined whether adding financial incentives for self-monitoring and achieving target weight losses increases weight losses attained in a fully online, group-based behavioral weight management program compared with the same program alone.
STUDY DESIGN


This study was an RCT.
SETTING/PARTICIPANTS


Adults with overweight and obesity (n=418; 91% female; 28% minority) were recruited from 2 clinical centers.
INTERVENTION


The intervention was a 24-session online group-based behavioral weight control program with weekly synchronous chat sessions (Internet-only) or the same program with weekly financial incentives for self-monitoring body weight and dietary intake daily and for achieving target weight losses at 2 and 6 months (Internet + incentives).
MAIN OUTCOME MEASURES


This study measured weight loss at 6 months and treatment engagement (attendance, self-monitoring of body weight, dietary intake, and physical activity). Data were collected between February 2016 and August 2018, and analyses were completed in 2019.
RESULTS


Participants randomized to the Internet + incentives group lost more weight (-6.4 [SD=5.5] kg) than those in the Internet-only group (-4.7 [SD=6.6] kg; p<0.01). Further, a higher proportion of the Internet + incentives group achieved ≥5% weight loss (55%) than those in the Internet-only group (40%; p<0.05). Treatment engagement was higher in the Internet + incentives condition, with greater self-monitoring of behaviors targeted by incentives, as well as higher rates of behaviors not targeted and higher self-reported physical activity. Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
CONCLUSIONS


Adding financial incentives to a program delivered fully online increases weight losses compared with the program alone and can achieve weight losses comparable to in-person programs, offering potential for substantial geographic reach.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02688621.",2020,"Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
","['Adults with overweight and obesity (n=418; 91% female; 28% minority) were recruited from 2 clinical centers', 'Data were collected between February 2016 and August 2018, and analyses were completed in 2019']",['24-session online group-based behavioral weight control program with weekly synchronous chat sessions (Internet-only) or the same program with weekly financial incentives for self-monitoring body weight and dietary intake daily and for achieving target weight losses at 2 and 6 months (Internet\u202f+\u202fincentives'],"['weight', 'Study retention', 'weight loss at 6 months and treatment engagement (attendance, self-monitoring of body weight, dietary intake, and physical activity', 'weight losses', 'weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0376283,"Study retention was higher among those in the Internet + incentives condition (91%) than those in the Internet-only condition (81%; p=0.003).
","[{'ForeName': 'Delia S', 'Initials': 'DS', 'LastName': 'West', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. Electronic address: westds@mailbox.sc.edu.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Sciences Center, Memphis, Tennessee.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke-NUS Medical School and Duke University Global Health Institute, Singapore and Durham, North Carolina.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Stansbury', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Doris E', 'Initials': 'DE', 'LastName': 'Ogden', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Monroe', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Chelsea A', 'Initials': 'CA', 'LastName': 'Carpenter', 'Affiliation': 'Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Naud', 'Affiliation': 'Biomedical Statistics, Larner College of Medicine, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jean R', 'Initials': 'JR', 'LastName': 'Harvey', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, Vermont.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.015']
1323,32447892,[Application of the situational simulation teaching method in occupational protection training for medical staff].,"Objective:  To investigate a new method for occupational protection training for medical staff, and to improve the awareness of occupational protection among medical staff.  Methods:  In August 2018, convenience sampling was performed to select 171 new medical workers in a grade A tertiary teaching hospital as subjects. The subjects were trained according to the requirements for occupational protection knowledge and training objectives. A questionnaire was distributed before training, and the scores were collected as control group; the subjects were trained using the conventional PPT theory, a questionnaire was distributed after training, and the scores were collected as trial group 1; the subjects were trained using the conventional PPT theory combined with the situational simulation teaching method, a questionnaire was distributed after training, and the scores were collected as trial group 2. A total of 171 questionnaires were distributed and collected for each survey, with a questionnaire recovery rate of 100%. Continuous data were expressed as mean±SD and were evaluated by an analysis of variance; categorical data were expressed as rate (%) , and the chi-square test was used for analysis.  Results:  A total of 171 medical workers, aged 22-33 years (mean 23.63±2.33 years) , participated in the study, among whom 127 (74.27%) were nurses, 146 (85.38%) were female workers, and 93 (54.39%) had a college degree. The awareness rate of occupational protection knowledge was 24.56%-70.18% in the control group, 63.16%-96.49% in the trial group 1, and 86.55%-99.42% in the trial group 2. There was a significant difference in the awareness rate of occupational protection knowledge among all the groups ( P <0.01) , and there were also significant differences in theoretical test score, skill assessment score, and total score among all the groups ( F =116.342, 189.424, and 304.904,  P <0.01) . Theoretical test score, skill assessment score, and total score tended to increase after the training based on the conventional PPT theory or the training based on the conventional PPT theory and situational simulation ( F =125.042, 352.025, and 444.073,  P <0.01) .  Conclusion:  The situational simulation teaching method for the training of occupational protection knowledge for medical staff has a marked training effect and can significantly improve the theoretical and skill levels of medical staff.",2020,"There was a significant difference in the awareness rate of occupational protection knowledge among all the groups ( P <0.01) , and there were also significant differences in theoretical test score, skill assessment score, and total score among all the groups ( F =116.342, 189.424, and 304.904,  P <0.01) .","['A total of 171 medical workers, aged 22-33 years (mean 23.63±2.33 years) , participated in the study, among whom 127 (74.27%) were nurses, 146 (85.38%) were female workers, and 93 (54.39%) had a college degree', 'medical staff', '171 new medical workers in a grade A tertiary teaching hospital as subjects']","['situational simulation teaching method in occupational protection training', 'occupational protection training', 'conventional PPT theory combined with the situational simulation teaching method']","['Theoretical test score, skill assessment score, and total score', 'theoretical test score, skill assessment score, and total score', 'awareness rate of occupational protection knowledge']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025106', 'cui_str': 'Medical Staffs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",171.0,0.0201023,"There was a significant difference in the awareness rate of occupational protection knowledge among all the groups ( P <0.01) , and there were also significant differences in theoretical test score, skill assessment score, and total score among all the groups ( F =116.342, 189.424, and 304.904,  P <0.01) .","[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Zhu', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Cui', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Wang', 'Affiliation': 'Department of Nosocomial Infection Management, The First Affiliated Hospital of Bengbu Medical College, Bengbu 233004, China.'}]",Zhonghua lao dong wei sheng zhi ye bing za zhi = Zhonghua laodong weisheng zhiyebing zazhi = Chinese journal of industrial hygiene and occupational diseases,['10.3760/cma.j.cn121094-20190321-00110']
1324,32448552,Randomized Trial of a Physical Activity Intervention for Latino Men: Activo.,"INTRODUCTION


Latino men experience disproportionately high rates of diseases related to low physical activity, yet they are poorly represented in physical activity intervention trials. Efforts to promote physical activity in Latina women show promising results, yet such interventions are yet to be extended to Latino men. This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time. Potential predictors of intervention success were also explored.
STUDY DESIGN


Randomized trial. Participants were randomized to receive a Tailored Physical Activity Intervention (Intervention) or a Wellness Control (Control). Data were collected in 2015-2017 and analyzed in 2018-2019.
SETTING/PARTICIPANTS


Insufficiently active Latino men (n=46).
INTERVENTION


Intervention participants received a baseline counseling session and then, individually tailored print materials and text messages on a tapered schedule for 6 months. Control participants received printed wellness materials and text messages on the same schedule.
MAIN OUTCOME MEASURES


Primary outcome was a change in weekly moderate to vigorous physical activity from baseline to 6 months measured by accelerometers. Self-reported moderate to vigorous physical activity measured by the 7-day Physical Activity Recall Interview was a secondary outcome.
RESULTS


For Intervention participants, median accelerometer-measured moderate to vigorous physical activity increased from 10.0 minutes/week at baseline to 57.5 minutes/week at 6 months, whereas for Control participants, it increased from 21.0 minutes/week at baseline to 23.0 minutes/week at 6 months (p<0.05). Similar results were found for self-reported moderate to vigorous physical activity. At 6 months, 47% of Intervention participants met national guidelines of 150 minutes/week versus 25% of Control participants (p=0.15, not significant).
CONCLUSIONS


Findings suggest that an individually tailored intervention can successfully increase moderate to vigorous physical activity in underactive Latino men. Such technology-supported interventions have the potential for broad dissemination.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02512419.",2020,"This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time.","['Insufficiently active Latino men (n=46', 'underactive Spanish-speaking Latino men', 'Latina women', 'Latino Men', 'underactive Latino men', 'Data were collected in 2015-2017 and analyzed in 2018-2019']","['Intervention participants received a baseline counseling session', 'Physical Activity Intervention', 'computer expert system‒tailored, text messaging-supported physical activity intervention', 'Tailored Physical Activity Intervention (Intervention) or a Wellness Control (Control', 'printed wellness materials and text messages']","['vigorous physical activity', 'median accelerometer-measured moderate to vigorous physical activity', '7-day Physical Activity Recall Interview', 'change in weekly moderate to vigorous physical activity']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0391853', 'cui_str': 'Underactive'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.0298802,"This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time.","[{'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California. Electronic address: blarsen@ucsd.edu.'}, {'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Mendoza-Vasconez', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Dori J', 'Initials': 'DJ', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health at University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, Department of Psychiatry and Human Behavior, Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'Jesse N', 'Initials': 'JN', 'LastName': 'Nodora', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island; Department of Human Development and Family Studies, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.007']
1325,32453396,"Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial.","BACKGROUND


It is unknown which compounds in spermatozoa or seminal plasma may be involved in the regulation of sperm motility.
OBJECTIVES


The aim of this study was to investigate the effects of DHA (22:6n-3), vitamin E, and their probable interactions in men with asthenozoospermia.
METHODS


A factorial, randomized, double-blind, placebo-controlled trial was conducted in infertility clinics in Tehran, Iran. The participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function. Their concentration of spermatozoa and percentage of morphologically normal spermatozoa were equal to or above the lower reference limits, according to the fifth edition of the WHO guideline. Out of 717 men referred to the infertility clinics, 180 asthenozoospermic men were randomly assigned to 1 of 4 groups according to stratified blocked randomization by age and sperm concentration. Participants took daily 465 mg DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP) for 12 wk. Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity were measured at baseline and after 12 wk.
RESULTS


After the intervention, mean ± SD sperm progressive motility was greater in the DE group (27.9 ± 2.8) than in the DP (25.7 ± 3.4), EP (26.1 ± 2.8), and PP (25.8 ± 2.6) groups (P < 0.05). Sperm count (P = 0.001) and concentration (P = 0.044) increased significantly in the DE group compared with the other 3 groups, whereas other semen parameters were not significantly different between the groups after the intervention. Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
CONCLUSIONS


Combined DHA and vitamin E supplements led to increased sperm motility; however, no significant changes occurred in sperm morphology and vitality in asthenozoospermic men.This trial was registered at clinicaltrials.gov as NCT01846325.",2020,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","['participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function', '717 men referred to the infertility clinics, 180 asthenozoospermic men', 'infertility clinics in Tehran, Iran', 'men with asthenozoospermia', 'asthenozoospermic men']","['DHA and vitamin E', 'DHA (22:6n-3), vitamin E', 'DHA and vitamin E supplements', 'DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP', 'placebo']","['Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity', 'sperm motility', 'Sperm count', 'Serum concentrations of n-3 PUFAs', 'spermatogram, seminal oxidative stress, and sperm phospholipids', 'mean\xa0±\xa0SD sperm progressive motility', 'sperm morphology and vitality']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0678896', 'cui_str': 'Endocrine function'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3715200', 'cui_str': 'Infertility clinic'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3661607', 'cui_str': 'Vitamin E supplement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0037842', 'cui_str': 'Sperm count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology'}]",717.0,0.607753,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Eslamian', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Amirjannati', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Noori', 'Affiliation': ""Division of Nephrology, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa124']
1326,32451615,Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study.,"OBJECTIVE


SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED.
METHODS


Eligible participants who completed 1-2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION.
RESULTS


Ninety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0-24 was 0.21 (0.16-0.29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17.4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
CONCLUSIONS


The effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01051349; first registered on January 15, 2010.",2020,"Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
","['up to 6\xa0years in participants with relapsing multiple sclerosis', 'Ninety percent (410/455) of participants who completed treatment', 'relapsing-remitting multiple sclerosis', 'Eligible participants who completed 1-2\xa0years of daclizumab beta treatment in SELECT/SELECTION received']","['daclizumab beta for ', 'daclizumab beta 150\xa0mg subcutaneously every 4\xa0weeks', 'daclizumab', 'daclizumab beta treatment', 'daclizumab beta']","['annualized relapse rate', 'serious adverse event (excluding multiple sclerosis relapse', 'serious hepatic events', 'clinical and radiologic outcomes', 'Overall incidence of 24-week confirmed disability progression', 'brain volume', 'Overall, hepatic events', 'immune-mediated encephalitis']","[{'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}]",,0.0418529,"Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'St. Josef-Hospital/Ruhr-University Bochum, 44791, Bochum, Germany. ralf.gold@rub.de.'}, {'ForeName': 'Ernst-Wilhelm', 'Initials': 'EW', 'LastName': 'Radue', 'Affiliation': 'Medical Image Analysis Center, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Selmaj', 'Affiliation': 'Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Eva Kubala', 'Initials': 'EK', 'LastName': 'Havrdova', 'Affiliation': 'Department of Neurology, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Hospital Vall d'Hebron University, Barcelona, Spain.""}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Stefoski', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Randy R', 'Initials': 'RR', 'LastName': 'Robinson', 'Affiliation': 'AbbVie Inc., Redwood City, CA, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Fam', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Chalkias', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giannattasio', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lima', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Castro-Borrero', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}]",Journal of neurology,['10.1007/s00415-020-09835-y']
1327,31424575,Health Literacy Matters More Than Experience for Advance Care Planning Knowledge Among Older Adults.,"BACKGROUND


Advance care planning (ACP) engagement is low among vulnerable populations, including those with limited health literacy (LHL). Limited knowledge about ACP may be a modifiable mediator of the relationship between LHL and ACP. Our goal was to determine whether health literacy is associated with ACP knowledge.
DESIGN


Cross-sectional design.
SETTING


A public health delivery system and Veterans Affairs Medical Center in San Francisco, CA.
PARTICIPANTS


English- and Spanish-speaking patients (N = 1400).
MEASUREMENTS


ACP knowledge was assessed with seven validated multiple-choice questions. Health literacy was measured using a validated scale. Sociodemographic measures included age, sex, language, education, race, health status, and social support. Prior ACP experience was defined as having documented legal forms and/or goals-of-care discussions in the medical record. We used Kruskal-Wallis tests and linear regression to examine associations of ACP knowledge with LHL, prior ACP experience, and sociodemographic factors.
RESULTS


Mean age of participants was 65 (±10) years, 48% were women, 34% had LHL, 32% were Spanish speaking, 47% had high school education or less, and 70% were nonwhite. Mean 7-point knowledge scores were lower for those with limited vs adequate health literacy (3.8 [SD = 1.9 vs 5.5 (SD = 1.7); P < .001). In multivariable analysis, ACP knowledge scores were 1.0 point lower among those with LHL; 0.6 points lower among Spanish speakers and those with high school education or less; and 0.5 points lower among individuals of nonwhite race (P < .001 for all). Knowledge scores were 0.02 points lower per year of older age (P = .007) and 0.01 points higher per point of greater social support (P = .005). Prior ACP experience was not associated with knowledge after adjustment (P = .7).
CONCLUSIONS


Health literacy and sociodemographics are stronger predictors than prior ACP experience of ACP knowledge. This study suggests that providing easy-to-understand ACP materials is paramount and should be offered even if patients have previous experience with the ACP process. J Am Geriatr Soc 67:2151-2156, 2019.",2019,Knowledge scores were 0.02 points lower per year of older age (P = .007) and 0.01 points higher per point of greater social support (P = .005).,"['English- and Spanish-speaking patients (N = 1400', 'Older Adults', 'Health Literacy Matters', 'patients have previous experience with the ACP process', 'A public health delivery system and Veterans Affairs Medical Center in San Francisco, CA', 'Mean age of participants was 65 (±10) years, 48% were women, 34% had LHL, 32% were Spanish speaking, 47% had high school education or less, and 70% were nonwhite']",[],"['ACP knowledge', 'ACP knowledge scores', 'Mean 7-point knowledge scores', 'Knowledge scores', 'Health literacy', 'age, sex, language, education, race, health status, and social support']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}]",[],"[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.0224261,Knowledge scores were 0.02 points lower per year of older age (P = .007) and 0.01 points higher per point of greater social support (P = .005).,"[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Nouri', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Aiesha M', 'Initials': 'AM', 'LastName': 'Volow', 'Affiliation': 'Division of Geriatrics, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'McMahan', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Kushel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Chengshi', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boscardin', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16129']
1328,32456617,"DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis: a single-center, randomized, double-blind, placebo-controlled study.","BACKGROUND


DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis.
METHODS


In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200 mg or 20 mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively.
RESULTS


48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5% ± 11.4% vs. 85.8% ± 12.5%, p = 0.000), whereas no change was found in placebo group (86.9% ± 11.6% vs. 87.8% ± 11.7%, p = 0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2 = 5.247, OR = 3.31, p = 0.022).
CONCLUSIONS


NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered (http://www.chictr.org.cn/index.aspx).",2020,"Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000).","['patients with carotid artery atherosclerotic stenosis', '2019', 'patients with large cerebral atherosclerotic stenosis', '48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis', '120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA']","['NBP or placebo', 'placebo', 'DL-3-n-butylphthalide', 'Single photon emission computed tomography (SPECT', 'DL-3-n-butylphthalide (NBP', 'NBP']","['CBF amelioration in ipsilateral MCA', 'ROIs with rCBF amelioration and stabilization', 'rCBF in ROIs', 'regional CBF (rCBF', 'cerebral blood flow (CBF', 'cerebral hypoperfusion', 'rCBF change for every ROI and the whole CBF change in MCA territory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1695782', 'cui_str': 'Cerebral hypoperfusion'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1695782', 'cui_str': 'Cerebral hypoperfusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301808', 'cui_str': 'State'}]",120.0,0.605911,"Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p = 0.000).","[{'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China. shijin_dr9@126.com.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Faguo', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""PET Center, Air Force Medical Center, PLA (People's Liberation Army), 30# Fucheng Road, Haidian District, Beijing, 100142, China.""}]",BMC neurology,['10.1186/s12883-020-01801-5']
1329,32460997,An international randomized phase III trial of pulse actinomycin-D versus multi-day methotrexate for the treatment of low risk gestational trophoblastic neoplasia; NRG/GOG 275.,"OBJECTIVES


Methotrexate and actinomycin-D are both effective first-line drugs for low-risk (WHO score 0-6) Gestational Trophoblastic Neoplasia (GTN) with considerable debate about which is more effective, less toxic, and better tolerated. The primary trial objective was to test if treatment with multi-day methotrexate (MTX) was inferior to pulse actinomycin-D (ACT-D). Secondary objectives included evaluation of severity and frequency of adverse events, and impact on quality of life (QOL).
METHODS


This was a prospective international cooperative group randomized phase III two arm non-inferiority study (Clinical Trials Identifier: (NCT01535053). The control arm was ACT-D; the experimental arm was multi-day MTX regimen (institutional preference of 5 or 8 day). Outcome measures included complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items.
RESULTS


The complete response rates for multi-day methotrexate and pulse actinomycin-D were 88% (23/26 patients) and 79% (22/28 patients) (p = NS) respectively, there were two recurrences in each arm, and 100% of patients survived. Significant toxicity was minimal, but mouth sores (mucositis), and eye pain were significantly more common in the MTX arm (p = 0.001 and 0.01 respectively). Quality of life showed no significant difference in overall quality of life, body image, sexual function, or treatment related side effects. The study was closed for low accrual rate (target 384, actual accrual 57), precluding statistical analysis of the primary objective.
CONCLUSIONS


The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance. The multi-day MTX regimens were associated with significantly more mucositis and were significantly less convenient.",2020,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.",['low risk gestational trophoblastic neoplasia; NRG/GOG 275'],"['pulse actinomycin-D (ACT-D', 'pulse actinomycin-D versus multi-day methotrexate', 'MTX', 'multi-day methotrexate (MTX', 'Methotrexate and actinomycin-D']","['complete response rates', 'mouth sores (mucositis), and eye pain', 'mucositis', 'evaluation of severity and frequency of adverse events, and impact on quality of life (QOL', 'Significant toxicity', 'overall quality of life, body image, sexual function, or treatment related side effects', 'complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items', 'complete response rate']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1135868', 'cui_str': 'Gestational trophoblastic neoplasia'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.121683,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.","[{'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Schink', 'Affiliation': 'Cancer Treatment Centers of America, Comprehensive Care and Research Center, Chicago, IL, USA. Electronic address: Julian.schink@CTCA-hope.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: FiliaciV@NRGOncology.org.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: HuangH@NRGOncology.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tidy', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: John.Tidy@sth.nhs.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Winter', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: matthew.winter@sth.nhs.uk.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, USA. Electronic address: carterj@mskcc.org.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Northwestern University, Chicago, IL, USA. Electronic address: naanders@nm.org.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Moxley', 'Affiliation': 'Oklahoma University Health Science Center, Oklahoma City, OK, USA. Electronic address: Katherine-Moxley@ouhsc.edu.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yabuno', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan. Electronic address: yabunoakira@yahoo.co.jp.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Taylor', 'Affiliation': 'Gynecologic Oncology, Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA. Electronic address: taylorse@upmc.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kushnir', 'Affiliation': ""Gynecologic Oncology, Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: ckushnir@wccenter.com.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Horowitz', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. Electronic address: nhorowitz@partners.org.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: david.miller@utsouthwestern.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.013']
1330,32468579,Talazoparib Exposure-Efficacy Analysis in Patients With Advanced Breast Cancer and Germline BRCA1/2 Mutations in the EMBRACA Trial.,"In the phase 3 EMBRACA trial, treatment with the poly(ADP-ribose) polymerase inhibitor, talazoparib, led to significantly improved progression-free survival (PFS) compared with chemotherapy (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P < .0001). We conducted an exposure-efficacy analysis using EMBRACA data from 285 patients who were treated with talazoparib and had available pharmacokinetic parameters to evaluate the effect of talazoparib exposure (time-varying average talazoparib concentration [C avg,t  ]) and other baseline variables on PFS. Graphical examination of the relationship between C avg,t  and PFS and a Cox proportional model were used. Exposure-response analyses showed that higher talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval >12 months were independent covariates associated with longer PFS. The association of talazoparib exposure with PFS (higher exposure, longer PFS) suggests the recommended starting dose of 1 mg once daily (the maximum tolerated dose) is appropriate.",2020,"Exposure-response analyses showed that higher talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval >12 months were independent covariates associated with longer PFS.","['285 patients who were treated with talazoparib and had available pharmacokinetic parameters to evaluate the effect of talazoparib exposure (time-varying average talazoparib concentration [C avg,t  ]) and other baseline variables on PFS', 'Patients With Advanced Breast Cancer and Germline BRCA1/2 Mutations in the EMBRACA Trial']",['Talazoparib'],"['progression-free survival (PFS', 'talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4042960', 'cui_str': 'talazoparib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",285.0,0.192879,"Exposure-response analyses showed that higher talazoparib exposure, absence of visceral disease, lower baseline lactate dehydrogenase levels, and disease-free interval >12 months were independent covariates associated with longer PFS.","[{'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Pfizer Inc., La Jolla, California, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmeliegy', 'Affiliation': 'Pfizer Inc., La Jolla, California, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Iulia Cristina', 'Initials': 'IC', 'LastName': 'Tudor', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Czibere', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., La Jolla, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1623']
1331,32603956,Leptin mediates improvements in cognitive function following treatment with infliximab in adults with bipolar depression.,"A potential role for leptin in the pathophysiology of bipolar disorder (BD) has been proposed. We recently investigated the effects of the tumor necrosis factor-alpha (TNF-α) antagonist infliximab in individuals with bipolar depression. Leptin is known to interact with the TNF-α system. Herein, we aimed to explore infliximab's effects on leptin and its relationship with brain structure and function. Sixty adults with bipolar depression were enrolled in this randomized, double-blind, 12-week clinical trial of adjunctive infliximab (n = 29) and saline control (n = 31), which were administered intravenously at weeks 0, 2, and 6. Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR) 1 and 2 were assessed at weeks 0, 2, 6, and 12. We observed a significant decrease in leptin levels in infliximab-treated patients, relative to placebo. Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels. Changes in sTNR2 levels at week 6 significantly determined changes in leptin at week 12 in infliximab-, but not placebo-treated participants. Improvements in verbal memory and increases in global cortical volume were associated with reduction in leptin levels in the treatment group. Mediation analysis indicated that cognitive improvement in infliximab-treated patients was mediated by reductions in leptin levels, which in its turn were determined by decreases in sTNR2 levels. In conclusion, infliximab treatment reduced plasma leptin levels in individuals with BD, through modulation of sTNFR2. Decreases in leptin signaling were associated with an increase in global cortical volume and better performance in a verbal memory task.",2020,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","['Sixty adults with bipolar depression', 'individuals with BD', 'adults with bipolar depression', 'individuals with bipolar depression']","['Leptin', 'saline control', 'adjunctive infliximab', 'infliximab', 'Infliximab', 'tumor necrosis factor-alpha (TNF-α) antagonist infliximab', 'placebo']","['leptin', 'cognitive improvement', 'global cortical volume and better performance in a verbal memory task', 'cognitive function', 'Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR', 'verbal memory', 'plasma leptin levels', 'global cortical volume', 'leptin signaling', 'leptin levels', 'TNF-α and sTNFR2', 'sTNR2 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.149116,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: rodrigo.mansur@uhn.ca.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; University of Ottawa, Department of Psychiatry, Ottawa, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Nasri', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Rashidian', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Kingston General Hospital, Providence Care Hospital, Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104779']
1332,32604430,"Music Therapy for Early Postoperative Pain, Anxiety, and Sleep in Patients after Mitral Valve Replacement.","BACKGROUND


To investigate the effect of music therapy on early postoperative pain, anxiety, and sleep quality in patients after mechanical mitral valve replacement (MVR).
METHODS


A total of 222 patients undergoing mechanical MVR were divided into two groups: the music group and the control group. The patients in the music group received 30 minutes of music therapy every day, whereas the patients in the control group had 30 minutes of quiet time. The visual analogue scale (VAS) was used to evaluate the degree of pain, and the Self-Rating Anxiety Scale (SAS) was used to evaluate the degree of early postoperative anxiety. We also recorded the sleep duration of the patients and used the Verran and Snyder-Halpern (VSH) Sleep Scale to evaluate the sleep quality of the patients.
RESULTS


The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group. The sleep duration in the music group was significantly greater than that in the control group. In the evaluation of sleep quality using the VSH Sleep Scale, the scores for sleep interruption, sleep length, sleep depth, degree of rest, and subjective sleep quality in the music group were significantly lower than those in the control group.
CONCLUSIONS


Music therapy can be an effective intervention to reduce early postoperative pain, relieve early postoperative anxiety, prolong sleep time, and improve the sleep quality of patients after mechanical MVR.",2020,"The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group.","['222 patients undergoing mechanical MVR', 'Patients after Mitral Valve Replacement', 'patients after mechanical mitral valve replacement (MVR']","['30\u2009minutes of music therapy', 'control group had 30\u2009minutes of quiet time', 'Music Therapy', 'music therapy', 'Music therapy']","['degree of pain, and the Self-Rating Anxiety Scale (SAS', 'VSH Sleep Scale, the scores for sleep interruption, sleep length, sleep depth, degree of rest, and subjective sleep quality', 'early postoperative anxiety', 'sleep duration', 'visual analogue scale (VAS', 'Verran and Snyder-Halpern (VSH) Sleep Scale', 'early postoperative pain, relieve early postoperative anxiety, prolong sleep time', 'early postoperative pain, anxiety, and sleep quality', 'sleep quality', 'Early Postoperative Pain, Anxiety, and Sleep', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0234452', 'cui_str': 'Prolonged sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",222.0,0.0232151,"The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group.","[{'ForeName': 'Qi-Liang', 'Initials': 'QL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0040-1713352']
1333,32605106,Hemodynamic Adaptations Induced by Short-Term Run Interval Training in College Students.,"Perceived lack of time is one of the most often cited barriers to exercise participation. High intensity interval training has become a popular training modality that incorporates intervals of maximal and low-intensity exercise with a time commitment usually shorter than 30 min. The purpose of this study was to examine the effects of short-term run interval training (RIT) on body composition (BC) and cardiorespiratory responses in undergraduate college students. Nineteen males (21.5 ± 1.6 years) were randomly assigned to a non-exercise control (CON,  n  = 10) or RIT ( n  = 9). Baseline measurements of systolic and diastolic blood pressure, resting heart rate (HRrest), double product (DP) and BC were obtained from both groups. VO 2max  and running speed associated with VO 2peak  (sVO 2peak ) were then measured. RIT consisted of three running treadmill sessions per week over 4 weeks (intervals at 100% sVO 2peak , recovery periods at 40% sVO 2peak ). There were no differences in post-training BC or VO 2 max between groups ( p  > 0.05). HRrest ( p  = 0.006) and DP ( p  ≤ 0.001) were lower in the RIT group compared to CON at completion of the study. RIT lowered HRrest and DP in the absence of appreciable BC and VO 2max  changes. Thereby, RIT could be an alternative model of training to diminish health-related risk factors in undergraduate college students.",2020,HRrest ( p  = 0.006) and DP ( p  ≤ 0.001) were lower in the RIT group compared to CON at completion of the study.,"['undergraduate college students', 'College Students', 'Nineteen males (21.5 ± 1.6 years']","['non-exercise control (CON,  n  = 10) or RIT', 'Short-Term Run Interval Training', 'High intensity interval training', 'short-term run interval training (RIT']","['body composition (BC) and cardiorespiratory responses', 'VO 2max  and running speed associated with VO 2peak  (sVO 2peak ', 'systolic and diastolic blood pressure, resting heart rate (HRrest), double product (DP) and BC']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",3.0,0.0570308,HRrest ( p  = 0.006) and DP ( p  ≤ 0.001) were lower in the RIT group compared to CON at completion of the study.,"[{'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'García-Suárez', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Rentería', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'García Wong-Avilés', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Franco-Redona', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Gómez-Miranda', 'Affiliation': 'Facultad de Deportes Tijuana, Universidad Autónoma de Baja California, Avenida Maclovio Herrera #4080, Colonia Francisco Villa, Tijuana 22615, Baja California, Mexico.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Aburto-Corona', 'Affiliation': 'Facultad de Deportes Tijuana, Universidad Autónoma de Baja California, Avenida Maclovio Herrera #4080, Colonia Francisco Villa, Tijuana 22615, Baja California, Mexico.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Plaisance', 'Affiliation': 'Department of Human Studies, University of Alabama at Birmingham, Education Building 901, 13th Street South, Birmingham, AL 35294, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Moncada-Jiménez', 'Affiliation': 'Human Movement Sciences Research Center (CIMOHU), University of Costa Rica, Ave. 31 Pavas, San José 1200, Costa Rica.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Jiménez-Maldonado', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17134636']
1334,32611648,"A Biomarker-enriched, Randomized Phase II Trial of Adavosertib (AZD1775) Plus Paclitaxel and Carboplatin for Women with Platinum-sensitive  TP53 -mutant Ovarian Cancer.","PURPOSE


Preclinical studies show that adavosertib, a WEE1 kinase inhibitor, sensitizes  TP53 -mutant cells to chemotherapy. We hypothesized that adavosertib, plus chemotherapy, would enhance efficacy versus placebo in  TP53 -mutated ovarian cancer.
PATIENTS AND METHODS


Following safety run-in, this double-blind phase II trial (NCT01357161) randomized women with  TP53 -mutated, platinum-sensitive ovarian cancer to oral adavosertib (225 mg twice daily for 2.5 days/21-day cycle) or placebo, plus carboplatin (AUC5) and paclitaxel (175 mg/m 2 ), until disease progression or for six cycles. The primary endpoints were progression-free survival (PFS) by enhanced RECIST v1.1 [ePFS (volumetric)] and safety. Secondary/exploratory objectives included PFS by RECIST v1.1 (single dimension), objective response rate, overall survival, and analysis of tumor gene profile versus sensitivity to adavosertib.
RESULTS


A total of 121 patients were randomized to adavosertib (A+C;  n  = 59) and placebo (P+C;  n  = 62) plus chemotherapy. Adding adavosertib to chemotherapy improved ePFS [median, 7.9 (95% confidence interval (CI), 6.9-9.9) vs. 7.3 months (5.6-8.2); HR 0.63 (95% CI, 0.38-1.06); two-sided  P  = 0.080], meeting the predefined significance threshold ( P  < 0.2). Clinical benefit was observed following A+C for patients with different  TP53  mutation subtypes, identifying possible response biomarkers. An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea (adavosertib 75%; placebo 37%), vomiting (63%; 27%), anemia (53%; 32%), and all grade ≥3 adverse events (78%; 65%).
CONCLUSIONS


Establishing an optimal strategy for managing tolerability and identifying specific patient populations most likely to benefit from treatment may increase clinical benefit. Future studies should consider additional adavosertib doses within the chemotherapy treatment cycle and the potential for maintenance therapy.",2020,An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea,"['women with platinum-sensitive  TP53 -mutant ovarian cancer', '121 patients', 'women with  TP53 -mutated, platinum-sensitive ovarian cancer to oral adavosertib (225 mg twice daily for 2.5 days/21-day cycle) or']","['adavosertib, plus chemotherapy', 'adavosertib (AZD1775) plus paclitaxel and carboplatin', 'placebo (P+C; n=62) plus chemotherapy', 'adavosertib (A+C', 'placebo, plus carboplatin (AUC5) and paclitaxel', 'placebo']","['diarrhea', 'progression-free survival (PFS) by enhanced RECIST v1.1 (ePFS [volumetric]) and safety', 'PFS by RECIST v1.1 (single dimension), objective response rate, overall survival, and analysis of tumor gene profile versus sensitivity to adavosertib', 'grade ≥3 adverse events', 'vomiting', 'anemia', 'adverse events', 'ePFS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",121.0,0.652253,An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea,"[{'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Canada. amit.oza@uhn.ca.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Estevez-Diz', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Universitäts-Frauenklinik Tübingen, Tübingen, Germany.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Nationales Centrum für Tumorerkrankungen, Heidelberg, Germany.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Uyar', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Laing', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'MT Statistics Ltd, East Kilbride, United Kingdom.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Freshwater', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lee', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Jingjun', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Merck Sharp & Dohme R&D, Beijing, China.'}, {'ForeName': 'Shelonitda', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Eric H', 'Initials': 'EH', 'LastName': 'Rubin', 'Affiliation': 'MRL, Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Stephenson Oklahoma Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0219']
1335,32611737,Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn's disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course.,"INTRODUCTION


Immunomodulators such as thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA) are well established for maintenance of remission within paediatric Crohn's disease (CD). It remains unclear, however, which maintenance medication should be used first line in specific patient groups.
AIMS


To compare the efficacy of maintenance therapies in newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution; MTX versus AZA/6MP in low-risk and MTX versus ADA in high-risk patients. Primary end point: sustained remission at 12 months (weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.
METHODS AND ANALYSIS


REDUCE-RISK in CD is an international multicentre open-label prospective randomised controlled trial funded by EU within the Horizon2020 framework (grant number 668023). Eligible patients (aged 6-17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal CD are stratified into low and high-risk groups based on phenotype and response to induction therapy. Participants are randomised to one of two treatment arms within their risk group: low-risk patients to weekly subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA. Patients are followed up for 12 months at prespecified intervals. Electronic case report forms are completed prospectively. The study aims to recruit 312 participants (176 low risk; 136 high risk).
ETHICS AND DISSEMINATION


ClinicalTrials.gov Identifier: (NCT02852694), authorisation and approval from local ethics committees have been obtained prior to recruitment. Individual informed consent will be obtained prior to participation in the study. Results will be published in a peer-reviewed journal with open access.
TRIAL REGISTRATION NUMBER


NCT02852694; Pre-results.",2020,"weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.
","['high-risk patients', ""paediatric Crohn's disease"", 'patients at low or high risk for aggressive disease course', '312 participants (176 low risk; 136 high risk', 'newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution', 'Eligible patients (aged 6-17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal\u2009CD']","['subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA', 'methotrexate versus azathioprine or adalimumab', 'thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA', 'MTX versus AZA/6MP', 'MTX versus ADA']",['sustained remission'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0341395', 'cui_str': ""Perianal Crohn's disease""}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.125767,"weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation.
","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Harris', 'Affiliation': 'Department of Paediatric Gastroenterology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Aloi', 'Affiliation': 'Paediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Roma, Lazio, Italy.'}, {'ForeName': 'Lissy', 'Initials': 'L', 'LastName': 'de Ridder', 'Affiliation': 'Paediatrics, Erasmus MC/Sophia Childrens Hospital, Rotterdam, The Netherlands l.deridder@erasmusmc.nl.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Croft', 'Affiliation': 'Department of Paediatric Gastroenterology, Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Koletzko', 'Affiliation': ""Pediatric Gastroenterology and Hepatology, Dr. V. Hauner Children's Hospital, Munich, Germany.""}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Edith Wolfson Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Department of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Gigi', 'Initials': 'G', 'LastName': 'Veereman', 'Affiliation': 'Pediatric GI, UZBrussels-VUB, Brussels, Belgium.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Neyt', 'Affiliation': 'ME-TA Medical Evaluation and Technology Assessment, Merendree, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Bigot', 'Affiliation': 'PIBD-Net, Hôpital universitaire Necker-Enfants malades, Paris, Île-de-France, France.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Ruemmele', 'Affiliation': 'Service de Gastroentérologie Pédiatrique, Hôpital Universitaire Necker-Enfants Malades, Paris, Île-de-France, France.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Russell', 'Affiliation': 'Department of Paediatric Gastroenterology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034892']
1336,32609756,Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.,"BACKGROUND


Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design.
METHODS AND FINDINGS


Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan-Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15-0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period.
CONCLUSIONS


ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02776254.",2020,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"['At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC', 'Zambian urban adherence club (AC', '489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female', 'HIV-infected adults in Zambia', '10 clinics were randomized to intervention (5 clinics) or control (5 clinics']",['differentiated service delivery (DSD'],"['rate of late drug pickup', 'median time since ART initiation', 'Median MPR', 'unadjusted Kaplan-Meier survival curves', 'time to first late drug pickup', 'median CD4 count', 'Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",10.0,0.184599,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bolton-Moore', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Izukanji', 'Initials': 'I', 'LastName': 'Sikazwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mpande', 'Initials': 'M', 'LastName': 'Mukumbwa-Mwenechanya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Efronson', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chanda', 'Initials': 'C', 'LastName': 'Mwamba', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Somwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kalunkumya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwansa', 'Initials': 'M', 'LastName': 'Lumpa', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Pry', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Wilbroad', 'Initials': 'W', 'LastName': 'Mutale', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': 'University of California, Berkeley, Berkeley, California, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Topp', 'Affiliation': 'James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Geng', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Holmes', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003116']
1337,32610370,Improving pulp revascularization outcomes with buccal fat autotransplantation.,"Several techniques have been introduced to improve the pulp revascularization outcomes. The use of the tissue graft can create more practical tissue regeneration, provide vascular supply, and enhance tissue healing. The aim of the present study was to investigate the histologic and molecular outcomes of pulp revascularization with buccal fat autotransplantation. Fifty-six open apex roots from four dogs aged 4-6 months were randomly allocated to five groups of endodontic regeneration models: Group 1 (negative control, n = 4); Group 2 (control and without intervention, n = 4); Group 3 (blood clot, n = 16); Group 4 (buccal fat autotransplantation, n = 16); and Group 5 (blood clot plus buccal fat autotransplantation, n = 16). After 3 months, the extracted dog teeth were analyzed by histological and immunohistochemical techniques. Furthermore, real-time quantitative polymerase chain reactions were implemented to assess the gene expression profiles of dentin sialophosphoprotein (DSPP), dentin matrix protein (DMP), collagen I (COL1), and alkaline phosphatase (ALP) on regenerated tissue in the root canals. There were no significant differences in the severity of inflammation and necrosis between intervention groups. Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin, and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes. The expression of DSPP gene increased significantly in Group 4. The expression of ALP gene increased significantly in Group 3. Using this procedure may open new fields of research for regenerative endodontic procedure in which tissue autotransplant, particularly adipose tissue, may improve the outcomes of pulp revascularization.",2020,"Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes.",['Fifty six open apex roots from 4 dogs aged 4-6 months'],"['endodontic regeneration models', 'pulp revascularization with buccal fat autotransplantation', ' Group 2 (control and without intervention, n=4); Group 3 (blood clot, n=16); Group 4 (buccal fat autotransplantation, n=16); Group 5 (blood clot plus buccal fat autotransplantation', 'buccal fat autotransplantation']","['expression of DSPP gene', 'severity of inflammation and necrosis', 'expression of DMP1 and COL1 genes', 'expression of ALP gene', 'gene expression profiles of dentin sialophosphoprotein (DSPP), dentin matrix protein (DMP), collagen I (COL1) and alkaline phosphatase (ALP']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0914005', 'cui_str': 'dentin sialophosphoprotein'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}]",,0.0184629,"Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes.","[{'ForeName': 'Saber', 'Initials': 'S', 'LastName': 'Khazaei', 'Affiliation': 'Department of Endodontics and Dental Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abbasali', 'Initials': 'A', 'LastName': 'Khademi', 'Affiliation': 'Department of Endodontics and Dental Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Torabinejad', 'Affiliation': 'School of Dentistry, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Nasr Esfahani', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Mozafar', 'Initials': 'M', 'LastName': 'Khazaei', 'Affiliation': 'Fertility and Infertility Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Sayed Mohammad', 'Initials': 'SM', 'LastName': 'Razavi', 'Affiliation': 'Department of Oral and Maxillofacial Pathology and Dental Implant Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.3094']
1338,32610511,Acute Effects of Open Kinetic Chain Exercise Versus Those of Closed Kinetic Chain Exercise on Quadriceps Muscle Thickness in Healthy Adults.,"This study aimed to compare immediate changes in the thickness of the rectus femoris (RF), vastus intermedius (VI), vastus lateralis (VL), vastus medialis (VM), and vastus medialis oblique (VMO) muscles after open kinetic chain exercise (OKCE) and closed kinetic chain exercise (CKCE) and identify the effect of both exercise types on each quadricep muscle for early rehabilitation to prevent knee joint injury. Twenty-six healthy participants (13 males and 13 females) were randomly divided into the OKCE ( n  = 13) and CKCE ( n  = 13) groups. The thickness of their quadriceps muscles was measured using a portable ultrasonic imaging device before and after exercise in the sequence RF, VI, VL, VM, and VMO. A two-way repeated measures analysis of variance was used to compare the thickness of each component of the quadriceps muscles between the two groups. The thickness of the RF, VL, VM, and VMO muscles increased after OKCE, and the thickness of the VI muscle showed the greatest increase with a medium-large effect size (F = 8.52,  p  = 0.01, and d = 0.53). The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71,  p  = 0.00, and d = 1.02). These results indicate that the thickness of the quadriceps muscles can be selectively improved depending on the type of exercise.",2020,"The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71,  p  = 0.00, and d = 1.02).","['Twenty-six healthy participants (13 males and 13 females', 'Healthy Adults']","['Open Kinetic Chain Exercise Versus', 'Closed Kinetic Chain Exercise', 'OKCE', 'CKCE', 'open kinetic chain exercise (OKCE) and closed kinetic chain exercise (CKCE']","['thickness of the RF, VL, VM, and VMO muscles', 'thickness of their quadriceps muscles', 'rectus femoris (RF), vastus intermedius (VI), vastus lateralis (VL), vastus medialis (VM), and vastus medialis oblique (VMO) muscles', 'thickness of the VI, VL, VM, and VMO muscles', 'Quadriceps Muscle Thickness']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0454289', 'cui_str': 'Open kinetic chain exercises'}, {'cui': 'C0454288', 'cui_str': 'Closed kinetic chain exercises'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224448', 'cui_str': 'Structure of vastus intermedius muscle'}]",26.0,0.0226761,"The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71,  p  = 0.00, and d = 1.02).","[{'ForeName': 'Soul', 'Initials': 'S', 'LastName': 'Cheon', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}, {'ForeName': 'Joo-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}, {'ForeName': 'Hyung-Pil', 'Initials': 'HP', 'LastName': 'Jun', 'Affiliation': 'Department of Physical Education, Dong-A University, Busan 49236, Korea.'}, {'ForeName': 'Yong Woo', 'Initials': 'YW', 'LastName': 'An', 'Affiliation': 'Department of Health and Human Sciences, Loyola Marymount University, Los Angeles, CA 90045, USA.'}, {'ForeName': 'Eunwook', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17134669']
1339,32610568,The Acute Impact of External Compression on Back Squat Performance in Competitive Athletes.,"The aim of the present study was to evaluate the effects of external compression with blood flow restriction on power output and bar velocity changes during the back-squat exercise (SQ). The study included 10 judo athletes (age = 28.4 ± 5.8 years; body mass = 81.3 ± 13.1 kg; SQ one-repetition maximum (1-RM) 152 ± 34 kg; training experience 10.7 ± 2.3 years).
METHODS


The experiment was performed following a randomized crossover design, where each participant performed three different exercise protocols: (1) control, without external compression (CONT); (2) intermittent external compression with pressure of 100% arterial occlusion pressure (AOP) (EC-100); and (3) intermittent external compression with pressure of 150% AOP (EC-150). To assess the differences between conditions, the participants performed 3 sets of 3 repetitions of the SQ at 70% 1-RM. The differences in peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the three conditions were examined using repeated measures two-way ANOVA.
RESULTS


The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p  = 0.03), PV ( p  = 0.02), MP ( p  = 0.04), and MV ( p  = 0.03), for the EC-150, compared to the CONT. Furthermore, a statistically significant increase in PP ( p  = 0.04), PV ( p  = 0.03), MP ( p  = 0.02), and MV ( p  = 0.01) were observed for the EC-150 compared to EC-100. There were no significant changes in PP, PV, MP, and MV, between EC-100 and CONT conditions.
CONCLUSION


The results indicate that the use of extremely high-pressure external compression (150% AOP) during high-loaded (70% 1-RM) lower limb resistance exercise elicits an acute increase in power output and bar velocity.",2020,"The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p  = 0.03),","['10 judo athletes (age = 28.4 ± 5.8 years; body mass = 81.3 ± 13.1 kg', 'Competitive Athletes']","['exercise protocols: (1) control, without external compression (CONT); (2) intermittent external compression with pressure of 100% arterial occlusion pressure (AOP) (EC-100); and (3) intermittent external compression with pressure of 150% AOP (EC-150', 'external compression with blood flow restriction', 'back-squat exercise (SQ', 'External Compression']","['PP', 'PV', 'PP, PV, MP, and MV, between EC-100 and CONT conditions', 'power output and bar velocity changes', 'power output and bar velocity', 'peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV', 'Back Squat Performance']","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0425273', 'cui_str': 'Competitive athlete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0158996', 'cui_str': 'Anemia of prematurity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",10.0,0.0501652,"The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p  = 0.03),","[{'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kostrzewa', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Jarosz', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Trybulski', 'Affiliation': 'Department of Medical Sciences, The Wojciech Korfanty School of Economics, 40-065 Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17134674']
1340,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
1341,32617006,Erratum: The Differences in Perceptions of Interprofessional Education Among Health Profession Students: The Indonesian Experience [Erratum].,[This corrects the article DOI: 10.2147/JMDH.S240195.].,2020,[This corrects the article DOI: 10.2147/JMDH.S240195.].,"['Health Profession Students', 'Erratum']",[],[],"[{'cui': 'C0018722', 'cui_str': 'Health Professions'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],,0.015601,[This corrects the article DOI: 10.2147/JMDH.S240195.].,[],Journal of multidisciplinary healthcare,['10.2147/JMDH.S262940']
1342,32617701,"A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue in patients treated for head and neck cancer.","PURPOSE


Fatigue is a distressing symptom in head & neck cancer patients before during and at the end of curative therapy. Pharmacologic and not pharmacologic treatments have been proposed with scarce or no evidence of efficacy. The aim of the study is to evaluate the efficacy of American ginseng in respect to placebo in reducing fatigue in patients treated for head and neck cancer with curative intent.
METHODS


Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1 year and had a global fatigue score > 4 by means of Brief Fatigue Inventory (BFI) were randomized to receive 1000 mg of American ginseng or placebo per day for 8 weeks with the aim to assess their efficacy. Changes in fatigue scores in the 2 subgroups of patients before and after the treatment with American ginseng or placebo, were assessed by the BFI at baseline and at the end of week 8.
RESULTS


The mean of the mean values of the BFI measured at 8 weeks (end of treatment) was 4.6 in the Ginseng arm and 3.4 in the Placebo arm (p = ns). Mean comparison showed a tendency to statistical significance only for the single item on interference with general activity (p = 0.06), with better performance for placebo. The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire.
CONCLUSION


The present data shows that American ginseng has insufficient evidence to be recommended for Cancer Related Fatigue (CRF) in post treatment HNC survivors.",2020,"The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire.
","['patients treated for head and neck cancer', 'patients treated for head and neck cancer with curative intent', 'head & neck cancer patients before during and at the end of curative therapy', 'Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1\xa0year and had a global fatigue score\u2009>\u20094 by means of Brief Fatigue Inventory (BFI']","['American ginseng', 'American ginseng or placebo', 'Placebo', 'ginseng', 'placebo']","['fatigue scores', 'mean of the mean values of the BFI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027533', 'cui_str': 'Neoplasm of neck'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",32.0,0.258747,"The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire.
","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Guglielmo', 'Affiliation': 'Oncology Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. mauro.guglielmo@istitutotumori.mi.it.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Di Pede', 'Affiliation': 'Oncology Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Alfieri', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Bergamini', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Platini', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Carla Ida', 'Initials': 'CI', 'LastName': 'Ripamonti', 'Affiliation': 'Oncology Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Orlandi', 'Affiliation': 'Radiation Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Nicola Alessandro', 'Initials': 'NA', 'LastName': 'Iacovelli', 'Affiliation': 'Radiation Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Maddalo', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - University of Brescia, Brescia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bossi', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03300-z']
1343,32457492,Melatonin for Treatment-Seeking Alcohol Use Disorder patients with sleeping problems: A randomized clinical pilot trial.,"A high percentage of subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties. Lack of sleep could lead AUD patients to relapse or, sometimes, to suicide. Most of the currently prescribed medications to treat this complex problem retain a high risk of side effects and/or dependence. Therefore, the aim of the current clinical trial is to investigate the possibility of the use of a safer treatment, such as the natural health product melatonin, to treat alcohol-related sleeping problems. Sixty treatment-seeking AUD subjects were assigned to melatonin (5 mg) or placebo for 4 weeks of treatment. Change in sleeping quality which is the primary outcome of the study was assessed using the Pittsburgh sleep quality index (PSQI) scale. Linear mixed models were used to statistically analyze the difference in scores before and after 4 weeks of treatment. There was a reduction in the global PSQI score in both groups with no significant drug effect between groups. In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment. However, higher doses are worth exploring in future research.",2020,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","['subjects diagnosed with alcohol use disorder (AUD) suffer from sleeping difficulties', 'Treatment-Seeking Alcohol Use Disorder patients with sleeping problems', 'Sixty treatment-seeking AUD subjects']","['Melatonin', 'melatonin', 'placebo']","['sleeping problems', 'global PSQI score', 'sleeping quality', 'Pittsburgh sleep quality index (PSQI) scale']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0808956,"In conclusion, the use of melatonin (5 mg)/day didn't differ from placebo in decreasing sleeping problems in a sample of AUD subjects after 4 weeks of treatment.","[{'ForeName': 'Marie N S', 'Initials': 'MNS', 'LastName': 'Gendy', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Lagzdins', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Schaman', 'Affiliation': 'Alcohol Research and Treatment Clinic, Acute Care Program, CAMH, Toronto, M6J 1H4, Ontario, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': 'Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, M5S 2S1, Ontario, Canada. bernard.lefoll@camh.ca.'}]",Scientific reports,['10.1038/s41598-020-65166-y']
1344,32462427,Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial.,"While preclinical stroke studies have shown that mesenchymal stem cells (MSCs) promote recovery, few randomized controlled trials (RCT) have assessed cell therapy in humans. In this RCT, we assessed the safety, feasibility, and efficacy of intravenous autologous bone marrow-derived MSCs in subacute stroke. ISIS-HERMES was a single-center, open-label RCT, with a 2-year follow-up. We enrolled patients aged 18-70 years less than 2 weeks following moderate-severe ischemic carotid stroke. Patients were randomized 2:1 to receive intravenous MSCs or not. Primary outcomes assessed feasibility and safety. Secondary outcomes assessed global and motor recovery. Passive wrist movement functional MRI (fMRI) activity in primary motor cortex (MI) was employed as a motor recovery biomarker. We compared ""treated"" and ""control"" groups using as-treated analyses. Of 31 enrolled patients, 16 patients received MSCs. Treatment feasibility was 80%, and there were 10 and 16 adverse events in treated patients, and 12 and 24 in controls at 6-month and 2-year follow-up, respectively. Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002). Intravenous autologous MSC treatment following stroke was safe and feasible. Motor performance and task-related MI activity results suggest that MSCs improve motor recovery through sensorimotor neuroplasticity. ClinicalTrials.gov Identifier NCT00875654.",2020,"Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002).","['Subacute Ischemic Stroke', 'primary motor cortex (MI', '31 enrolled patients, 16 patients received', 'subacute stroke', 'enrolled patients aged 18-70\xa0years less than 2\xa0weeks following moderate-severe ischemic carotid stroke']","['intravenous MSCs', 'intravenous autologous bone marrow-derived MSCs', 'Intravenous autologous MSC', 'MSCs', 'Autologous Mesenchymal Stem Cells']","['task-related fMRI activity in MI-4a', 'global and motor recovery', 'safety, feasibility, and efficacy', 'motor-NIHSS', 'feasibility and safety', 'motor-Fugl-Meyer scores', 'Passive wrist movement functional MRI (fMRI) activity', 'Barthel Index, NIHSS, and modified-Rankin scores']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}]",31.0,0.338725,"Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002).","[{'ForeName': 'Assia', 'Initials': 'A', 'LastName': 'Jaillard', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France. Jaillard@univ-grenoble-alpes.fr.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hommel', 'Affiliation': 'AGEIS EA 7407, Université Grenoble Alpes (UGA), Grenoble, France.'}, {'ForeName': 'Anaick', 'Initials': 'A', 'LastName': 'Moisan', 'Affiliation': 'Cell Therapy and Engineering Unit, EFS Rhône Alpes Auvergne, Saint Ismier, France.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zeffiro', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Isabelle M', 'Initials': 'IM', 'LastName': 'Favre-Wiki', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Barbieux-Guillot', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Vadot', 'Affiliation': 'Stroke Unit, CH Annecy-Genevois, Epagny Metz-Tessy, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Marcel', 'Affiliation': 'Stroke Unit, CH Métropole Savoie, Chambéry, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Lamalle', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Grand', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Detante', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Translational stroke research,['10.1007/s12975-020-00787-z']
1345,32460315,Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial.,"Purpose


To compare changes in relative peripheral refraction (RPR) associated with myopia progression in myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses over 2 years.
Methods


A 2-year double-blind, randomized controlled trial was conducted on 183 myopic children. Subjects were allocated to either wearing DIMS (n = 93) or SV spectacle lenses (n = 90). Peripheral refraction at 10°, 20°, and 30° of the nasal (10N, 20N, 30N) and temporal (10T, 20T, 30T) retinal eccentricities, central refraction, and axial length after cycloplegia were monitored every 6 months.
Results


DIMS group showed symmetrical peripheral myopic shifts between the nasal and temporal retina (comparing myopic shifts between the nasal and temporal retina, the difference between the corresponding eccentricities were nonclinically significance). SV group showed asymmetrical peripheral myopic shifts between the nasal and temporal retina, with more myopic shifts (all P ≤ 0.001) at 10T (-0.32 ± 0.62 diopters [D]), at 20T (-0.69 ± 0.95 D), and 30T (-0.85 ± 1.52 D). No significant changes in RPR spherical equivalent (M) were noted in the DIMS group, whereas significant increases (all P < 0.0001) in hyperopic RPR M were observed at 10N (0.27 ± 0.45 D), 20N (0.75 ± 0.72 D), and 30N (0.98 ± 0.76 D) in the SV group.
Conclusions


Wearing DIMS lenses resulted in a significantly different peripheral refraction profile and RPR changes, as well as significant myopia control effects when compared with SV lenses. Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.",2020,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","['183 myopic children', 'myopic children wearing Defocus Incorporated']","['Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses', 'wearing DIMS', 'SV spectacle lenses']","['symmetrical peripheral myopic shifts', '30T) retinal eccentricities, central refraction, and axial length after cycloplegia', 'RPR spherical equivalent (M', 'peripheral refraction and slowed central myopia progression', 'hyperopic RPR M', 'relative peripheral refraction (RPR', 'Peripheral refraction', 'peripheral refraction profile and RPR changes', 'asymmetrical peripheral myopic shifts', 'Relative Peripheral Refraction', 'myopia control effects']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0181607', 'cui_str': 'Spectacle lens'}, {'cui': 'C1275648', 'cui_str': 'Single vision glasses'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0235238', 'cui_str': 'Cycloplegia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",183.0,0.154496,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","[{'ForeName': 'Han Yu', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ',.'}, {'ForeName': 'Carly Siu Yin', 'Initials': 'CSY', 'LastName': 'Lam', 'Affiliation': ',.'}, {'ForeName': 'Wing Chun', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': ',.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Leung', 'Affiliation': ',.'}, {'ForeName': 'Chi Ho', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': ',.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.5.53']
1346,32469106,Addressing social stressors in a brief motivational interview improve mental health symptoms for Latinx heavy drinkers.,"OBJECTIVE


Depressive and anxiety symptoms co-occur with hazardous drinking among Latinxs. This secondary analysis of a clinical trial to reduce hazardous drinking (motivational interviewing adapted to address social stressors [CAMI] vs. motivational interviewing [MI]) examined effects on anxiety/depressive symptoms. Discrimination and acculturation were examined as moderators.
METHODS


Latinx (n = 296) hazardous drinkers (2+ occasions/month of heavy drinking; 4/5 drinks/occasion, females/males) were randomized to CAMI/MI. Generalized estimating equations analyzed how treatment conditions and interactions were related to depressive and anxiety symptoms after controlling for covariates.
RESULTS


Baseline symptoms (anxiety, depression) exceeded clinical thresholds (Anxiety ≥8, M = 14.62, SD = 13.52; Depression ≥ 12, M = 18.78, SD = 12.57). Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI. CAMI with high baseline discrimination reported significantly less depression than MI (12 months).
CONCLUSIONS


Explicitly addressing social stressors may be a beneficial adjunct to treatment for Latinx drinkers.",2020,"Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI.","['Latinx heavy drinkers', 'Latinx drinkers', 'Latinx (n\u2009', '296) hazardous drinkers (2+ occasions/month of heavy drinking; 4/5 drinks/occasion, females/males', 'Depressive and anxiety symptoms co-occur with hazardous drinking among Latinxs']","['Cultural adaptation of motivational interviewing (CAMI', 'hazardous drinking (motivational interviewing adapted to address social stressors [CAMI] vs. motivational interviewing [MI', 'CAMI/MI']","['anxiety and depressive symptoms', 'depressive and anxiety symptoms', 'anxiety/depressive symptoms', 'mental health symptoms', 'Baseline symptoms (anxiety, depression) exceeded clinical thresholds ']","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.0149421,"Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI.","[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Practice, Boston University School of Social Work, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosales', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Koriann', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Department of Applied Psychology, Northeastern University, Boston, Massachusetts.'}, {'ForeName': 'Damaris J', 'Initials': 'DJ', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}]",Journal of clinical psychology,['10.1002/jclp.22976']
1347,31814531,Comparative effectiveness of a standard behavioral and physical activity enhanced behavioral weight loss intervention in Black women.,"Black women typically lose small amounts of weight in behavioral weight loss interventions, partially due to low engagement in physical activity. Culturally relevant enhancement of the physical activity component may improve weight loss. This study compared the effectiveness of a culturally-relevant, physical activity-enhanced behavioral weight loss intervention to a standard behavioral weight loss intervention in Black women (n = 85) over 6 months. The study was conducted in two cohorts from March 2016 to February 2017 at the University of North Carolina at Chapel Hill. Participants had an average age of 48.30 ± 11.02 years with an average body mass index of 36.46 ± 4.50 kg/m 2 . Standard and enhanced groups' weight change (-2.83 kg and -2.08 kg, respectively) and change in physical activity (43.93 min/ week and 15.29 min/week, respectively) did not differ between groups. Significantly more standard group participants lost 5% of baseline weight compared to enhanced group participants. This study produced typical weight loss results in Black women. Behavioral weight loss treatment remains moderately effective for Black women. Strategies to increase attendance and self-monitoring, and the inclusion of cultural contexts to weight-related behaviors are needed to improve outcomes.",2020,"Standard and enhanced groups' weight change (-2.83 kg and -2.08 kg, respectively) and change in physical activity (43.93 min/ week and 15.29 min/week, respectively) did not differ between groups.","['Participants had an average age of 48.30 ± 11.02 years with an average body mass index of 36.46 ± 4.50 kg/m 2 ', 'two cohorts from March 2016 to February 2017 at the University of North Carolina at Chapel Hill', 'Black women', 'Black women (n = 85) over 6 months']","['Behavioral weight loss treatment', 'standard behavioral and physical activity enhanced behavioral weight loss intervention', 'culturally-relevant, physical activity-enhanced behavioral weight loss intervention', 'standard behavioral weight loss intervention']","['weight loss', 'physical activity', 'weight change']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0558275', 'cui_str': 'Chapel'}, {'cui': 'C0442532', 'cui_str': 'Hill'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",,0.0321959,"Standard and enhanced groups' weight change (-2.83 kg and -2.08 kg, respectively) and change in physical activity (43.93 min/ week and 15.29 min/week, respectively) did not differ between groups.","[{'ForeName': 'Loneke T', 'Initials': 'LT', 'LastName': 'Blackman Carr', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut , Storrs, Connecticut, USA.'}, {'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Samuel-Hodge', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Evenson', 'Affiliation': 'Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University , Hamilton, Ontario, Canada.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Health Behavior, Department of Nutrition, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}]",Women & health,['10.1080/03630242.2019.1700585']
1348,32474564,Oral S-1 with 24-h Infusion of Irinotecan plus Bevacizumab versus FOLFIRI plus Bevacizumab as First-Line Chemotherapy for Metastatic Colorectal Cancer: An Open-Label Randomized Phase II Trial.,"BACKGROUND


FOLFIRI plus bevacizumab have been widely used as first-line treatment for metastatic colorectal cancer (mCRC). Pharmacokinetics and pharmacodynamics suggested a low dose of irinotecan given as a long-term infusion is expected to enhance antitumor activity. We conducted a randomized phase II study to compare oral S-1 with a 24-h infusion of irinotecan plus bevacizumab versus FOLFIRI plus bevacizumab.
METHODS


The subjects comprised 120 chemotherapy-naïve patients with mCRC. The study group received a 24-h infusion of irinotecan at a dose of 125 mg/m2 on days 1 and 15, combined with oral S-1 80 mg/m2 on days 1-14 (24h-SIRI/B). The FOLFIRI/B group received irinotecan at a dose of 150 mg/m2, 5-fluorouracil given at a dose of 400 mg/m2 as a bolus injection and at a dose of 2,400 mg/m2 as a 46-h infusion, and 200 mg/m2 leucovorin on days 1 and 15. Bevacizumab was given at a dose of 5.0 mg/kg on days 1 and 15 in both groups. Treatment was repeated every 4 weeks. The primary endpoint was 1-year progression-free survival (PFS). Secondary endpoints were PFS, response rates (RR), overall survival (OS), and adverse events (AEs).
RESULTS


From December 2013 through January 2018, 120 patients were randomly assigned, 61 patients to the 24h-SIRI/B and 59 patients to the FOLFIRI/B. The median follow-up period was 22.8 months. The 1-year PFS rate was 43.14% in the 24h-SIRI/B arm and 19.15% in the FOLFIRI/B arm (HR = 0.312 [95%CI 0.13-0.78], p = 0.01). The median PFS was 10.2 months (95%CI 8.8-14.3) and 10.0 months (95%CI 7.4-11.0), and the median OS was 29.7 months (95%CI 22.9-43.9) and 28.8 months (95%CI 18.4-ND), respectively (p = 0.3758, p = 0.8234). The overall RR was 86.3 and 61.7%, respectively (p = 0.0053). AEs were similar.
CONCLUSIONS


Our results show that the 24h-SIRI/B regimen is an effective and reasonably well-tolerated regimen for the first-line treatment of mCRC.",2020,"The overall RR was 86.3 and 61.7%, respectively (p = 0.0053).","['metastatic colorectal cancer (mCRC', 'Metastatic Colorectal Cancer', 'From December 2013 through January 2018', 'subjects comprised 120 chemotherapy-naïve patients with mCRC', '120 patients were randomly assigned, 61 patients to the 24h-SIRI/B and 59 patients to the FOLFIRI/B']","['leucovorin', 'Bevacizumab', 'Irinotecan plus Bevacizumab versus FOLFIRI plus Bevacizumab', 'irinotecan plus bevacizumab versus FOLFIRI plus bevacizumab', '5-fluorouracil', 'irinotecan', 'bevacizumab']","['median OS', '1-year PFS rate', 'PFS, response rates (RR), overall survival (OS), and adverse events (AEs', '1-year progression-free survival (PFS', 'overall RR', 'median PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.214759,"The overall RR was 86.3 and 61.7%, respectively (p = 0.0053).","[{'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Sadahiro', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan, sadahiro@is.icc.u-tokai.ac.jp.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Kazutake', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Gota', 'Initials': 'G', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyakita', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogimi', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Lin Fung', 'Initials': 'LF', 'LastName': 'Chan', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kamei', 'Affiliation': 'Department of Surgery, Tokai University, School of Medicine, Isehara, Japan.'}]",Oncology,['10.1159/000507293']
1349,32476971,"Corrigendum to The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.",[This corrects the article DOI: 10.1177/1179573519899471.].,2020,[This corrects the article DOI: 10.1177/1179573519899471.].,['Patients With Ischemic Stroke in the Early Subacute Recovery Phase'],['Rehabilitation-oriented Virtual Reality Device'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],,0.125302,[This corrects the article DOI: 10.1177/1179573519899471.].,[],Journal of central nervous system disease,['10.1177/1179573520923280']
1350,32482999,Ephedrine versus Phenylephrine Effect on Cerebral Blood Flow and Oxygen Consumption in Anesthetized Brain Tumor Patients: A Randomized Clinical Trial.,"BACKGROUND


Studies in anesthetized patients suggest that phenylephrine reduces regional cerebral oxygen saturation compared with ephedrine. The present study aimed to quantify the effects of phenylephrine and ephedrine on cerebral blood flow and cerebral metabolic rate of oxygen in brain tumor patients. The authors hypothesized that phenylephrine reduces cerebral metabolic rate of oxygen in selected brain regions compared with ephedrine.
METHODS


In this double-blinded, randomized clinical trial, 24 anesthetized patients with brain tumors were randomly assigned to ephedrine or phenylephrine treatment. Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen in peritumoral and normal contralateral regions were performed before and during vasopressor infusion. The primary endpoint was between-group difference in cerebral metabolic rate of oxygen. Secondary endpoints included changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation.
RESULTS


Peritumoral mean ± SD cerebral metabolic rate of oxygen values before and after vasopressor (ephedrine, 67.0 ± 11.3 and 67.8 ± 25.7 μmol · 100 g · min; phenylephrine, 68.2 ± 15.2 and 67.6 ± 18.0 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 1.5 [-13.3 to 16.3] μmol · 100 g · min [P = 0.839]). Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values (ephedrine, 90.8 ± 15.9 and 94.6 ± 16.9 μmol · 100 g · min; phenylephrine, 100.8 ± 20.7 and 96.4 ± 17.7 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 8.2 [-2.0 to 18.5] μmol · 100 g · min [P = 0.118]). Ephedrine significantly increased cerebral blood flow (difference [95% CI], 3.9 [0.7 to 7.0] ml · 100 g · min [P = 0.019]) and regional cerebral oxygen saturation (difference [95% CI], 4 [1 to 8]% [P = 0.024]) in the contralateral hemisphere compared to phenylephrine. The change in oxygen extraction fraction in both regions (peritumoral difference [95% CI], -0.6 [-14.7 to 13.6]% [P = 0.934]; contralateral hemisphere difference [95% CI], -0.1 [- 12.1 to 12.0]% [P = 0.989]) were comparable between groups.
CONCLUSIONS


The cerebral metabolic rate of oxygen changes in peritumoral and normal contralateral regions were similar between ephedrine- and phenylephrine-treated patients. In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.",2020,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","['Anesthetized Brain Tumor Patients', 'brain tumor patients', '24 anesthetized patients with brain tumors', 'anesthetized patients without cerebral pathology', 'adult patients with brain tumors', 'anesthetized patients']","['ephedrine- and phenylephrine', 'ephedrine or phenylepherine', 'phenylephrine and ephedrine', 'phenylephrine', 'ephedrine or phenylephrine', 'Phenylephrine', 'ephedrine', 'Ephedrine']","['cerebral metabolic rate of oxygen', 'Peritumoral mean ± SD cerebral metabolic rate of oxygen values', 'Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values', 'cerebral blood flow and cerebral metabolic rate of oxygen', 'cerebral blood flow and regional cerebral oxygen saturation', 'change in oxygen extraction fraction', 'Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen', 'contralateral hemisphere difference', 'Cerebral Blood Flow and Oxygen Consumption', 'cerebral blood flow', 'regional cerebral oxygen saturation', 'cerebral metabolic rate of oxygen changes', 'changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation']","[{'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.583823,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","[{'ForeName': 'Klaus U', 'Initials': 'KU', 'LastName': 'Koch', 'Affiliation': 'From the Department of Anesthesiology, Section of Neuroanesthesia (K.U.K., N.J., L.N., M.R.) Department of Nuclear Medicine and PET Center (J.A.) Department of Neurosurgery (G.v.O.) Department of Neuroradiology (L.Ø.), Aarhus University Hospital, Aarhus, Denmark Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark (I.K.M., L.Ø.) Department of Anesthesiology, Horsens Regional Hospital, Horsens, Denmark (U.S.E.) Institute of Neuroradiology, Charité, Universitätsmedizin, Berlin, Germany (A.T.).'}, {'ForeName': 'Irene K', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Aanerud', 'Affiliation': ''}, {'ForeName': 'Ulrick S', 'Initials': 'US', 'LastName': 'Espelund', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tietze', 'Affiliation': ''}, {'ForeName': 'Gorm V', 'Initials': 'GV', 'LastName': 'Oettingen', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': ''}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003377']
1351,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1352,31806872,Randomized post-induction and delayed intensification therapy in high-risk pediatric acute lymphoblastic leukemia: long-term results of the international AIEOP-BFM ALL 2000 trial.,,2020,,['high-risk pediatric acute lymphoblastic leukemia'],['Randomized post-induction and delayed intensification therapy'],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0023452', 'cui_str': 'Lymphoblastic Leukemia, Acute, Childhood'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0277782,,"[{'ForeName': 'Andishe', 'Initials': 'A', 'LastName': 'Attarbaschi', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria. andishe.attarbaschi@stanna.at.""}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Mann', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Medical School Hannover, Hannover, Germany.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': ""Department of Children and Adolescent Medicine, Children's Hospital, Goethe University, Frankfurt, Germany.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barisone', 'Affiliation': ""Pediatric Onco-Hematology, Regina Margherita Children's Hospital, AOU Città della Salute e della Scienza, Turin, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Basso', 'Affiliation': 'Italian Institute for Genomic Medicine, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Biondi', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Cario', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Cazzaniga', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Colombini', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Flotho', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Albert Ludwigs University, Freiburg, Germany.""}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kuhlen', 'Affiliation': ""University Children's Hospital Augsburg, Swabian Children's Cancer Center, Augsburg, Germany.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Eberhard Karls University, Tübingen, Germany.""}, {'ForeName': 'Melchior', 'Initials': 'M', 'LastName': 'Lauten', 'Affiliation': ""Department of Pediatric and Adolescent Medicine, Children's Hospital, University of Lübeck, Lübeck, Germany.""}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Linderkamp', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital, Medical School Hannover, Hannover, Germany.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Department of Pediatric Hematology-Oncology, IRCCS ""Bambino Gesù"" Children\'s Hospital, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lo Nigro', 'Affiliation': 'Center of Pediatric Hematology Oncology, Azienda Policlinico-OVE, Catania, Italy.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Möricke', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Niggli', 'Affiliation': ""Department of Pediatric Oncology, University Children's Hospital, Zürich, Switzerland.""}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Panzer-Grümayer', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Parasole', 'Affiliation': 'Department of Pediatric Hemato-Oncology, A.O.R.N. Santobono-Pausilipon, Naples, Italy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': ""Department of Pediatric Hematology and Oncology, St. Anna Children's Hospital, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Caterina Putti', 'Affiliation': 'Department of Woman and Child Health, Clinic of Pediatric Haematology-Oncology, University of Padova, Padova, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Rizzari', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Meinolf', 'Initials': 'M', 'LastName': 'Suttorp', 'Affiliation': 'Department of Pediatrics, Pediatric Hemato-Oncology Unit, Children\'s Hospital, University Hospital ""Carl Gustav Carus"", Dresden, Germany.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Valsecchi', 'Affiliation': 'Center of Biostatistics for Clinical Epidemiology, Department of Health Science, University of Milano-Bicocca, Milano, Italy.'}, {'ForeName': 'Valentino', 'Initials': 'V', 'LastName': 'Conter', 'Affiliation': 'Pediatric Hematology-Oncology Unit, Department of Pediatrics, University of Milano-Bicocca, MBBM Foundation/ASST Monza, Monza, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': 'Department of Pediatrics, Christian-Albrechts-University Kiel and University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-019-0670-y']
1353,32583727,Effects of an aerobic fitness test on short- and long-term memory in elementary-aged children.,"Meta-analytic evidence supports that exercise has benefits for short-term memory (STM) and long-term memory (LTM). However, only three studies with children have tested the differential effects of exercise on STM and LTM. The purpose of this study was to examine the effects of an aerobic fitness test on STM and LTM and to consider the moderating effects of grade level. Children (7-13 years of age) were randomly assigned to either perform an aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT) to assess memory. Memory was tested again after approximately 24 hours. There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders. For learning, Day 1 Retention, 24-hr recall, and Day 2 Retention, the exercise prior group performed better than the exercise post group. It is concluded that an aerobic fitness test performed prior to a declarative memory test benefits LTM as compared to when the aerobic fitness test is performed after the memory test.",2020,There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders.,"['Children (7-13\xa0years of age', 'elementary-aged children']","['aerobic fitness test before (exercise prior) or after (exercise post) performing the Rey Auditory Verbal Learning Test (RAVLT', 'aerobic fitness test']","['short- and long-term memory', 'memory performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0423909', 'cui_str': 'Long-term memory performance'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",,0.031325,There were significant differences in memory performance as a function of grade with 4 th  and 6 th  graders consistently outperforming 2 nd  graders.,"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sprick', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Chia-Hao', 'Initials': 'CH', 'LastName': 'Shih', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Glass', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}, {'ForeName': 'Jarod C', 'Initials': 'JC', 'LastName': 'Vance', 'Affiliation': 'Department of Kinesiology, University of North Carolina Greensboro , Greensboro, NC, USA.'}]",Journal of sports sciences,['10.1080/02640414.2020.1778251']
1354,32585354,The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.,"BACKGROUND


Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies.
OBJECTIVE


To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received.
METHODS


Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT.
RESULTS


Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT.
CONCLUSIONS


In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016']
1355,32590084,Blood transfusion and ischaemic outcomes according to anemia and bleeding in patients with non-ST-segment elevation acute coronary syndromes: Insights from the TAO randomized clinical trial.,"BACKGROUND


The benefits and risks of blood transfusion in patients with acute myocardial infarction who are anemic or who experience bleeding are debated. We sought to study the association between blood transfusion and ischemic outcomes according to haemoglobin nadir and bleeding status in patients with NST-elevation myocardial infarction (NSTEMI).
METHODS


The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to heparin plus eptifibatide versus otamixaban. After exclusion of patients who underwent coronary artery bypass surgery, patients were categorized according to transfusion status considering transfusion as a time-varying covariate. The primary ischemic outcome was the composite of all-cause death or MI within 180 days of randomization. Subgroup analyses were performed according to pre-transfusion hemoglobin nadir and bleeding status.
RESULTS


12,547 patients were enrolled. Among these, blood transfusion was used in 489 (3.9%) patients. Patients who received transfusion had a higher rate of death or MI (29.9% vs. 8.1%, p<0.01). This excess risk persisted after adjustment on GRACE score and nadir of hemoglobin (HR 3.36 95%CI 2.63-4.29 p<0.01). Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir > 9.0 g/dl (HR 4.01; p-interaction<0.0001).
CONCLUSION


In patients with NSTEMI, blood transfusion was associated with an overall increased risk of ischaemic events. However, this was mainly driven by patients without overt bleeding and those hemoglobin nadir > 9.0g/dl. This suggests possible harm of transfusion in those groups.",2020,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"['patients with NST-elevation myocardial infarction (NSTEMI', 'The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to', 'patients with acute myocardial infarction who are anemic or who experience bleeding are debated', 'patients with non-ST-segment elevation acute coronary syndromes', '12,547 patients were enrolled']","['blood transfusion', 'coronary artery bypass surgery', 'heparin plus eptifibatide versus otamixaban']","['anemia and bleeding', 'GRACE score and nadir of hemoglobin', 'risk of ischaemic events', 'composite of all-cause death or MI', 'Blood transfusion and ischaemic outcomes', 'rate of death or MI', 'blood transfusion', 'haemoglobin nadir and bleeding status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C1097497', 'cui_str': 'otamixaban'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",12547.0,0.115362,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Deharo', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France; Aix Marseille Univ, Inserm, Inra, C2VN, Marseille, France; Aix-Marseille Université, Faculté de Médecine, F-13385 Marseille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Heart Center Freiburg University, Cardiology and Angiology I, Faculty of Medicine, Freiburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Rutgers-New Jersey medical school, Newark, New Jersey, USA; Newark Beth Israel medical centre, Newark, New Jersey, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Pollack', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Department of Cardiology, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands; The Netherlands Heart Institute, Utrecht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'University of Latvia, Pauls Stradins Clinical University Hospita, Riga, Latvia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Fondazione Cardiocentro Ticino, via Tesserete 48, 6900 Lugano, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale, Paris, France.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, UK. Electronic address: gabriel.steg@aphp.fr.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.020']
1356,32591267,The Effect of Motivational Interviewing on Women with Overweight and Obesity Before Conception.,"OBJECTIVE


To investigate the efficacy of motivational interviewing (MI) to elicit change in eating and physical activity behaviors in women with overweight and obesity before conception.
DESIGN


A randomized controlled trial was conducted. The participants were randomly divided into intervention and comparison groups. Data were gathered using the Three-Factor Eating Questionnaire Revised 18-item version (TFEQ-R18), International Physical Activity Questionnaire (IPAQ), and Stages of Change checklist.
SETTING


Primary health centers of Tabriz, Iran.
PARTICIPANTS


The participants were 70 women with overweight or obesity, aged 18-35 years, who were referred for preconception care.
INTERVENTION(S)


The intervention group received 6 MI sessions, and the comparison group received routine preconception care.
MAIN OUTCOME MEASURE(S)


Variables of primary outcomes were eating behavior measures and physical activity levels 8 weeks after intervention.
ANALYSIS


Independent t test, ANCOVA, Fisher exact test, Mann-Whitney U test, and Wilcoxon test were used.
RESULTS


The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively). After the intervention, the mean score of cognitive restraint in the intervention group was higher than in the comparison group (adjusted mean difference, 16.9; 95% CI, 10.8 to 23.0; P < .001), whereas there were no significant differences between the 2 groups in terms of emotional and uncontrolled eating (P = .33 and P = .25, respectively).
CONCLUSIONS AND IMPLICATIONS


The MI had a positive effect on physical activity and eating behavior change, except for uncontrolled and emotional eating. Future studies to examine differences between overweight and women with obesity and within other populations is warranted.",2020,"The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively).","['women with overweight and obesity before conception', 'Primary health centers of Tabriz, Iran', 'participants were 70 women with overweight or obesity, aged 18-35 years, who were referred for preconception care', 'Women with Overweight and Obesity Before Conception']","['6 MI sessions, and the comparison group received routine preconception care', 'motivational interviewing (MI', 'Motivational Interviewing']","['mean score of cognitive restraint', 'Factor Eating Questionnaire Revised 18-item version (TFEQ-R18), International Physical Activity Questionnaire (IPAQ), and Stages of Change checklist', 'emotional and uncontrolled eating', 'physical activity', 'eating and physical activity behaviors', 'eating behavior measures and physical activity levels', 'physical activity and eating behavior change']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085284', 'cui_str': 'Preconception care'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0085284', 'cui_str': 'Preconception care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",70.0,0.0661103,"The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively).","[{'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Nourizadeh', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Azami', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Azizeh', 'Initials': 'A', 'LastName': 'Farshbaf-Khalili', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: b.mehrabi62@gmail.com.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.04.219']
1357,32596882,Cognitive behavioural therapy for insomnia does not appear to have a substantial impact on early markers of cardiovascular disease: A preliminary randomized controlled trial.,"According to the World Health Organization, cardiovascular diseases are the leading cause of death in the world. Therefore, early prevention of these diseases is a public health priority. Epidemiological data suggest that insomnia may be a modifiable risk factor for cardiovascular diseases. A randomized controlled trial in a sample of insomnia patients without cardiovascular disease was conducted to investigate the effects of insomnia treatment on early markers of cardiovascular diseases assessed by 24-hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples. Forty-six patients with insomnia disorder were randomized to cognitive behavioural therapy for insomnia (CBT-I; n = 23) or a waitlist control condition (n = 23). Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3). Potential methodological and conceptual reasons for these negative findings are discussed. Future studies might include larger sample sizes that are at risk of cardiovascular diseases and focus on other cardiovascular markers.",2020,"Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3).","['Forty-six patients with insomnia disorder', 'insomnia patients without cardiovascular disease']","['Cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia (CBT-I; n\xa0=\xa023) or a waitlist control condition']","['early markers of cardiovascular disease', '24-hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",46.0,0.0606613,"Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3).","[{'ForeName': 'Anna Friederike', 'Initials': 'AF', 'LastName': 'Johann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Hertenstein', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, Bern, Switzerland.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Feige', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Umair', 'Initials': 'U', 'LastName': 'Akram', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Holub', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Baglioni', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nissen', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, Bern, Switzerland.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Sleep and Circadian Neuroscience Institute (SCNi), University of Oxford, Oxford, UK.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Riemann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Biermann', 'Affiliation': 'Department of Cardiology and Angiology, Cardiac Electrophysiology, St. Franziskus-Hospital Münster, Münster, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Spiegelhalder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}]",Journal of sleep research,['10.1111/jsr.13102']
1358,32619413,Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: retrospective long-term follow-up of the LIR!C trial.,"BACKGROUND


The LIR!C trial showed that laparoscopic ileocaecal resection is a cost-effective treatment that has similar quality-of-life outcomes to treatment with infliximab, an anti-tumour necrosis factor (TNF) drug. We aimed to compare long-term outcomes of both interventions and identify baseline factors associated with the duration of treatment effect in each group.
METHODS


In this retrospective follow-up study, we collected data from patients who participated in the LIR!C trial, a multicentre randomised controlled trial that compared quality of life after surgical resection versus infliximab in adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease. From Jan 1 to May 1, 2018, we collected follow-up data from the time from enrolment in the LIR!C trial until the last visit at either the gastrointestinal surgeon or gastroenterologist. In this study, outcomes of interest were need for surgery or repeat surgery or anti-TNF therapy, duration of treatment effect, and identification of factors associated with the duration of treatment effect. Duration of treatment effect was defined as the time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery).
FINDINGS


We collected long-term follow-up data for 134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group. Median follow-up was 63·5 months (IQR 39·0-94·5). In the resection group, 18 (26%) of 69 patients started anti-TNF therapy and none required a second resection. 29 (42%) patients in the resection group did not require additional Crohn's disease-related medication, although 14 (48%) of these patients were given prophylactic immunomodulator therapy. In the infliximab group, 31 (48%) of 65 patients had a Crohn's disease-related resection, and the remaining 34 patients maintained, switched, or escalated their anti-TNF therapy. Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52). In both groups, therapy with an immunomodulator, in addition to the allocated treatment, was associated with duration of treatment effect (hazard ratio for resection group 0·34 [95% CI 0·16-0·69] and for infliximab group 0·49 [0·26-0·93]).
INTERPRETATION


These findings further support laparoscopic ileocaecal resection as a treatment option in patients with Crohn's disease with limited (affected segment ≤40 cm) and predominantly inflammatory terminal ileitis for whom conventional treatment is not successful.
FUNDING


None.",2020,"Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52).","[""patients with Crohn's disease with limited (affected segment ≤40 cm"", '134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group', 'patients who participated in the LIR!C trial', ""Crohn's disease"", ""adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease""]","['infliximab', 'laparoscopic ileocaecal resection', 'surgical resection versus infliximab', 'Laparoscopic ileocaecal resection versus infliximab']","[""time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery"", 'Duration of treatment effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0700426', 'cui_str': 'Ileocecal'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0400056', 'cui_str': 'Right hemicolectomy and end to end anastomosis of ileum to colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.135364,"Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52).","[{'ForeName': 'Toer W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Haasnoot', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'Buskens', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'E Joline', 'Initials': 'EJ', 'LastName': 'de Groof', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Eshuis', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Tjibbe J', 'Initials': 'TJ', 'LastName': 'Gardenbroek', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Mol', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pieter C F', 'Initials': 'PCF', 'LastName': 'Stokkers', 'Affiliation': 'Department of Gastroenterology and Hepatology, OLVG West, Amsterdam, Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: w.a.bemelman@amsterdamumc.nl.'}, {'ForeName': 'Cyriel Y', 'Initials': 'CY', 'LastName': 'Ponsioen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30117-5']
1359,32619524,Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.,"BACKGROUND


Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
OBJECTIVES


The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes.
METHODS


In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076']
1360,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
1361,32620262,High-dose versus low-dose tranexamic acid for paediatric craniosynostosis surgery: a double-blind randomised controlled non-inferiority trial.,"BACKGROUND


Tranexamic acid (TXA) reduces blood loss and transfusion in paediatric craniosynostosis surgery. The hypothesis is that low-dose TXA, determined by pharmacokinetic modelling, is non-inferior to high-dose TXA in decreasing blood loss and transfusion in children.
METHODS


Children undergoing craniosynostosis surgery were enrolled in a two-centre, prospective, double-blind, randomised, non-inferiority controlled trial to receive high TXA (50 mg kg -1  followed by 5 mg kg -1  h -1 ) or low TXA (10 mg kg -1  followed by 5 mg kg -1  h -1 ). Primary outcome was blood loss. Low dose was determined to be non-inferior to high dose if the 95% confidence interval (CI) for the mean difference in blood loss was above the non-inferiority margin of -20 ml kg -1 . Secondary outcomes were transfusion, TXA plasma concentrations, and biological markers of fibrinolysis and inflammation.
RESULTS


Sixty-eight children were included. Values were non-inferior regarding blood loss (39.4 [4.4] vs 40.3 [6.2] ml kg -1  [difference=0.9; 95% CI: -14.2, 15.9]) and blood transfusion (21.3 [1.6] vs 23.6 [1.5] ml kg -1  [difference=2.3; 95% CI: -2.1, 6.7]) between high-dose (n=32) and low-dose (n=34) groups, respectively. The TXA plasma concentrations during surgery averaged 50.2 (8.0) and 29.6 (7.6) μg ml -1 . There was no difference in fibrinolytic and inflammatory biological marker concentrations. No adverse events were observed.
CONCLUSIONS


Tranexamic acid 10 mg kg -1  followed by 5 mg kg -1  h -1  is not less effective than a higher dose of 50 mg kg -1  and 5 mg kg -1  h -1  in reducing blood loss and transfusion in paediatric craniosynostosis surgery.
CLINICAL TRIAL REGISTRATION


NCT02188576.",2020,"No adverse events were observed.
","['paediatric craniosynostosis surgery', 'Sixty-eight children were included', 'Children undergoing craniosynostosis surgery']","['TXA', 'High-dose versus low-dose tranexamic acid', 'Tranexamic acid (TXA', 'low TXA', 'Tranexamic acid']","['TXA plasma concentrations', 'fibrinolytic and inflammatory biological marker concentrations', 'adverse events', 'transfusion, TXA plasma concentrations, and biological markers of fibrinolysis and inflammation', 'blood transfusion', 'blood loss']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",68.0,0.800882,"No adverse events were observed.
","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Goobie', 'Affiliation': ""Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: susan.goobie@childrens.harvard.edu.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Staffa', 'Affiliation': ""Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Meara', 'Affiliation': ""Department of Plastic and Oral Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Proctor', 'Affiliation': ""Department of Neurosurgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Tumolo', 'Affiliation': 'Department of Anaesthesia, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Cangemi', 'Affiliation': 'Central Laboratory of Analyses, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Disma', 'Affiliation': 'Department of Anaesthesia, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.054']
1362,32620370,Evaluation of effectiveness of three-dimensional printed ear splint therapy following ear elevation surgery in microtia patients: A randomized controlled trial.,"AIM


This study aimed to compare the effectiveness of a 3D-printed ear splint with that of a conventional thermoplastic ear splint after microtia reconstruction.
METHODS


Patients who underwent ear elevation surgery with postauricular fascia coverage between October 2017 and October 2018 were included. They were randomly divided into the experimental group (3D-printed ear splint) and the control group (thermoplastic ear splint) and underwent routine postoperative rehabilitation and antiscar therapy. Splint therapy was initiated 4 weeks postoperatively and continued until 24 weeks postoperatively. The evaluated indices were the Vancouver scar scale score (VSS score), cranioauricular distance, patient compliance, complications (dermatitis, skin ulcers, skin necrosis), and patient satisfaction. A two-group t-test was carried out to compare all variables except patient satisfaction, which was compared using the Mann-Whitney U-test; p < 0.05 was considered significant.
RESULTS


Twenty patients were included in each group. At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups. At 24 weeks postoperatively, the mean VSS scores were 4.85 ± 1.46 and 6.25 ± 1.74 (p = 0.009), the mean cranioauricular distances were 15.80 ± 1.82 mm and 13.95 ± 1.93 mm (p = 0.004), and the patient satisfaction scores were 4.5 ± 0.51 and 3.7 ± 0.47 (p < 0.001) in the experimental group and the control group, respectively, all showing significant differences. Two patients in each group exhibited skin irritation or skin ulcers, which resolved after 6 months of follow-up.
CONCLUSION


The application of 3D-printed ear splints provides better inhibition of scar contracture, better maintenance of ear projection and higher patient satisfaction than conventional ear splints following ear elevation surgery in microtia patients. Therefore, 3D-printed ear splints should be preferred over conventional ear splints whenever possible.",2020,"At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups.","['microtia patients', 'Twenty patients were included in each group', 'Patients who underwent ear elevation surgery with postauricular fascia coverage between October 2017 and October 2018 were included']","['Splint therapy', '3D-printed ear splint', 'three-dimensional printed ear splint therapy', 'conventional thermoplastic ear splint', 'conventional ear splints', 'control group (thermoplastic ear splint) and underwent routine postoperative rehabilitation and antiscar therapy']","['mean cranioauricular distances', 'mean VSS scores', 'skin irritation or skin ulcers', 'Vancouver scar scale score (VSS score), cranioauricular distance, patient compliance, complications (dermatitis, skin ulcers, skin necrosis), and patient satisfaction', 'VSS score', 'cranioauricular distance', 'patient satisfaction scores']","[{'cui': 'C0152423', 'cui_str': 'Microtia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442168', 'cui_str': 'Postauricular'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0037299', 'cui_str': 'Skin ulcer'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0151799', 'cui_str': 'Skin necrosis'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",20.0,0.0512882,"At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Zin Mar', 'Initials': 'ZM', 'LastName': 'Aung', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Sousan', 'Initials': 'S', 'LastName': 'Cheong', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Taeho', 'Initials': 'T', 'LastName': 'Won', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Ruhong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China. Electronic address: fanjj3177@sh9hospital.org.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China. Electronic address: handong12000@163.com.""}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.06.003']
1363,32621073,"Conscious perception and the modulatory role of dopamine: no effect of the dopamine D2 agonist cabergoline on visual masking, the attentional blink, and probabilistic discrimination.","RATIONALE


Conscious perception is thought to depend on global amplification of sensory input. In recent years, striatal dopamine has been proposed to be involved in gating information and conscious access, due to its modulatory influence on thalamocortical connectivity.
OBJECTIVES


Since much of the evidence that implicates striatal dopamine is correlational, we conducted a double-blind crossover pharmacological study in which we administered cabergoline-a dopamine D2 agonist-and placebo to 30 healthy participants. Under both conditions, we subjected participants to several well-established experimental conscious-perception paradigms, such as backward masking and the attentional blink task.
RESULTS


We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
CONCLUSIONS


Our results cast doubt on a causal role for dopamine in visual perception. It remains an open possibility that dopamine has causal effects in other tasks, perhaps where perceptual uncertainty is more prominent.",2020,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
",['30 healthy participants'],"['cabergoline-a dopamine D2 agonist-and placebo', 'dopamine D2 agonist cabergoline', 'backward masking and the attentional blink task', 'cabergoline', 'dopamine']","['visual masking, the attentional blink, and probabilistic discrimination']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",30.0,0.0541971,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Boonstra', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands. evertboonstra@gmail.com.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'van Schouwenburg', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Seth', 'Affiliation': 'Department of Informatics Sackler Centre for Consciousness Science, University of Sussex, Brighton, BN1 9QJ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Zantvoord', 'Affiliation': 'Department of Child and Adolescent Psychiatry, The Bascule, Academic Centre for Child and Adolescent Psychiatry Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Pharmacy, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Lansink', 'Affiliation': 'Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Slagter', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05579-9']
1364,32621898,The Aravind Pseudoexfoliation Study: 5-Year Postoperative Results. The Effect of Intraocular Lens Choice and Capsular Tension Rings.,"PURPOSE


We compared rates of intraocular lens (IOL) decentration, neodymium-doped yttrium aluminum garnet capsulotomy for posterior capsule opacification (PCO), and visual acuity (VA) in eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery.
DESIGN


Prospective comparative interventional study.
METHODS


This multicenter study population included 1 eye of both 930 cataract patients with and 470 cataract patients without uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons. Eyes were randomized to either 1- or 3-piece intraocular lenses (IOLs). PEX eyes were also randomized to either receive or not receive a capsule tension ring. The main outcome measures included IOL decentration and PCO. Secondary outcomes included postoperative best-corrected VA.
RESULTS


Follow-up was 86.2% in the PEX group and 86.7% in the control group at 5 years. The PEX group was older (P < .001) and had more men (P = .01). IOL decentration at 5 years was equally prevalent in PEX and control eyes (1.0% vs 1.1%, respectively, P = .8). Neodymium-doped yttrium aluminum garnet posterior capsulotomy rates for PCO were similar in the PEX group when compared with control subejcts (5.3% compared with 3.2%, respectively, P = .07). Best corrected VA was better at baseline and years 2 and 3 in the control group (P = .0001, P = .0005, and P = .02); however, there was no difference in BCVA at years 1, 4, and 5 between the PEX and control groups (P = .09, P = .29, and P = .5).
CONCLUSION


In a large-scale, long-term, prospective comparative study of cataract surgery in eyes with uncomplicated PEX, the risks of IOL decentration and PCO were low and comparable to that in control subjects. When approaching cataract surgery in eyes with relatively uncomplicated PEX, neither IOL choice (1- vs 3-piece acrylic IOL) nor the presence/absence of a capsule tension ring affects outcomes at 5 years.",2020,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","['eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery', '930 cataract patients with, and 470 cataract patients without, uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons', 'PEX eyes']","['one-piece or three-piece intraocular lenses (IOL', 'PEX', 'IOL decentration, Nd:YAG capsulotomy', 'capsule tension ring (CTR', 'cataract surgery']","['PCO', 'post-operative best corrected VA', 'IOL decentration', 'IOL decentration and posterior capsular opacification (PCO', 'Best corrected visual acuity (BCVA', 'BCVA', 'posterior capsule opacification (PCO), and visual acuity (VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C2939415', 'cui_str': 'Phacodonesis'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.0815359,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Haripriya', 'Affiliation': 'Aravind Eye Hospital, Chennai, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Schehlein', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Shekhar', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Chandrashekharan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Narendran', 'Affiliation': 'Aravind Eye Hospital, Coimbatore, India.'}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sithiq', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Rengappa', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Ravilla D', 'Initials': 'RD', 'LastName': 'Ravindran', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Robin', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA; Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA. Electronic address: arobin@glaucomaexpert.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.031']
1365,32627803,Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial.,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.",2020,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.","['Nigeria', '60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring']",['community health worker support and home monitoring'],"['blood pressure control', 'systolic blood pressure']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",60.0,0.0620388,"In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.","[{'ForeName': 'Dike B', 'Initials': 'DB', 'LastName': 'Ojji', 'Affiliation': 'Cardiology Unit, Department of Medicine, College of Health Sciences, University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria. Email: dike.ojji@uniabuja,edu,ng.'}, {'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Baldridge', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Orji', 'Affiliation': 'Disease Control Unit, Department of Health, Abuja Municipal Area Council, Federal Capital Territory, Nigeria.'}, {'ForeName': 'Lamkur G', 'Initials': 'LG', 'LastName': 'Shedul', 'Affiliation': 'Department of Family Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Olubunmi I', 'Initials': 'OI', 'LastName': 'Ojji', 'Affiliation': 'Department of Community Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Nonye B', 'Initials': 'NB', 'LastName': 'Egenti', 'Affiliation': 'Department of Community Medicine, University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Ada M', 'Initials': 'AM', 'LastName': 'Nwankwo', 'Affiliation': 'Department of Community Medicine, College of Health Sciences University of Abuja and University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2019-066']
1366,32624277,"Re: Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multi-centre Study.",,2020,,['Patients with High-risk Prostate Cancer'],"['Curative-intent Surgery or Radiotherapy (proPSMA', 'Prostate-specific Membrane Antigen PET-CT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0420324,,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Ploussard', 'Affiliation': 'Department of Urology, La Croix du Sud Hospital, Quint Fonsegrives, France. Electronic address: g.ploussard@gmail.com.'}]",European urology,['10.1016/j.eururo.2020.06.017']
1367,32624282,"Erratum to 'Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received' [European Urology 77 (2020) 320-330].",,2020,,['Men with Localised Prostate Cancer'],[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0635376,,"[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK. Electronic address: David.Neal@nds.ox.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology & Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, Department of Surgery & Cambridge Urology Translational Research and Clinical Trials, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Doug G', 'Initials': 'DG', 'LastName': 'Altman', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.05.030']
1368,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978']
1369,32473959,A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers.,"Few trial data are available concerning the impact of personalised cancer risk information on behaviour. This study assessed the short-term effects of providing personalised cancer risk information on cancer risk beliefs and self-reported behaviour. We randomised 1018 participants, recruited through the online platform Prolific, to either a control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice. The primary outcome was change from baseline in computed risk relative to an individual with a recommended lifestyle (RRI) 1  at three months. Secondary outcomes included: health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction. After three months there were no between-group differences in change in RRI (p = 0.71). At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group. The increases in accuracy and conviction were only seen in individuals with high numeracy and low baseline conviction, respectively. These findings suggest that personalised cancer risk information alongside lifestyle advice can increase short-term risk accuracy and conviction without increasing worry or anxiety but has little impact on health-related behaviour. Trial registration: ISRCTN17450583. Registered 30 January 2018.",2020,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","['1018 participants, recruited through the online platform Prolific, to either a']","['control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice', 'personalised cancer risk information', 'online risk information and lifestyle advice']","['computed risk relative to an individual with a recommended lifestyle (RRI', 'accuracy and conviction', 'health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction', 'accuracy of absolute risk perception', 'absolute and comparative risk conviction', 'change in RRI', 'intention to increase fruit and vegetables', 'cancer risk beliefs and self-reported behaviour']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1547273', 'cui_str': 'Preventable'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",1018.0,0.105156,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","[{'ForeName': 'Golnessa', 'Initials': 'G', 'LastName': 'Masson', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: gh453@medschl.cam.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: kmills@medschl.cam.ac.uk.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge CB2 0QQ, UK. Electronic address: stephen.sharp@mrc-epid.cam.ac.uk.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'National Cancer Institute, Rockville, MD, USA. Electronic address: kleinwm@mail.nih.gov.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: srs34@medschl.cam.ac.uk.'}, {'ForeName': 'Juliet A', 'Initials': 'JA', 'LastName': 'Usher-Smith', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: jau20@medschl.cam.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106154']
1370,32475171,Pressurized-Bag Irrigation Versus Hand-Operated Irrigation Pumps During Ureteroscopic Laser Lithotripsy: Comparison of Infectious Complications.,"Introduction and Objectives:  A variety of irrigation systems are available during ureteroscopy. We sought to compare gravity-driven pressure bags with hand-operated irrigation pumps in terms of postoperative complications after ureteroscopy with lithotripsy.  Methods:  A retrospective analysis of 234 patients undergoing flexible ureteropyeloscopy with laser lithotripsy by 24 supervised trainees over 4 years at a single teaching institution. Patients were divided into those who had procedures performed by using gravity-driven pressure bags fixed at 60 to 204 cm H 2 O,  vs  those who had procedures performed by using a hand-operated irrigation pump capable of delivering 1 to 10 mL per flush. Variables including surgical duration, hypotension, fever, sepsis, and hematuria were extracted from the charts, along with the surgical techniques utilized. Statistical analyses included chi-squared tests and Student's  t -tests.  Results:  There were no differences in gender, age, indication, or stone size in the two groups. Postoperative systemic inflammatory response syndrome was significantly greater in the hand-assisted  n  = 11/144 (7.6%) compared with the fixed irrigation group  n  = 1/90 (1.1%);  p  = 0.032. Emergency room presentations were greater in the hand irrigation group,  n  = 46/144 (32%)  vs n  = 12/90 (13%) in the pressure-bag irrigation,  p  = 0.002. Postoperative fever was also greater in the hand pump irrigation cohort compared with the continuous pressure cohort (13/144 [9%]  vs  1/90 [1%],  p  = 0.011). No statistical difference was found between the two groups with respect to stone clearance and subsequent procedures required ( p  = 0.123).  Conclusions:  This analysis suggests that using continuous flow irrigation at a fixed maximum pressure of 150 mmHg (204 cm H 2 O) or less may result in decreased pain, infection, and sepsis compared with handheld pressure irrigation.",2020,"Emergency room presentations were greater in the hand irrigation group n=46/144 (32%) versus n=12/90 (13%) in the pressure-bag irrigation, p= 0.002.","['by 24 supervised trainees over 6 years at a single teaching institution', '234 patients undergoing']","['flexible ureteropyeloscopy with laser lithotripsy', 'gravity driven pressure bags fixed at 60-150 cmH20, versus those who had procedures using a hand operated irrigation pump capable of delivering 1-10mL per flush', 'ureteroscopic laser lithotripsy', 'Pressurized-bag irrigation versus hand-operated irrigation pumps', 'gravity-driven pressure bags to hand-operated irrigation pumps']","['Post-operative SIRS', 'pain, infection, and sepsis', 'unplanned re-admissions and emergency presentations', 'surgical duration, hypotension, fever, sepsis, and haematuria', 'Emergency room presentations', 'Post-operative fever']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",234.0,0.0437799,"Emergency room presentations were greater in the hand irrigation group n=46/144 (32%) versus n=12/90 (13%) in the pressure-bag irrigation, p= 0.002.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Farag', 'Affiliation': 'Department of Urology, Austin Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Timm', 'Affiliation': 'Department of Urology, Austin Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Davis', 'Affiliation': 'Department of Urology, Tallaght Hospital, Dublin, Ireland.'}, {'ForeName': 'Lih-Ming', 'Initials': 'LM', 'LastName': 'Wong', 'Affiliation': 'Department of Urology, St Vincents Hospital, Melbourne, Australia.'}, {'ForeName': 'Damien M', 'Initials': 'DM', 'LastName': 'Bolton', 'Affiliation': 'Department of Urology, Austin Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Jack', 'Affiliation': 'Department of Urology, Austin Health, University of Melbourne, Melbourne, Australia.'}]",Journal of endourology,['10.1089/end.2020.0148']
1371,32476455,A multicomponent intervention to decrease sedentary time during hospitalization: a quasi-experimental pilot study.,"OBJECTIVE


The aim of this study was to evaluate the feasibility and preliminary effects of a multicomponent intervention to decrease sedentary time during and shortly after hospitalization.
DESIGN


This is a quasi-experimental pilot study comparing outcomes in patients admitted before and after the implementation of the intervention.
SETTING


The study was conducted in a university hospital.
SUBJECTS


Participants were adult patients undergoing elective organ transplantation or vascular surgery.
INTERVENTIONS


In the control phase, patients received usual care, whereas in the intervention phase, patients also received a multicomponent intervention to decrease sedentary time. The intervention comprised eight elements: paper and digital information, an exercise movie, an activity planner, a pedometer and Fitbit Flex™, a personal activity coach and an individualized digital training program.
MEASURES


Measures of feasiblity were the self-reported use of the intervention components (yes/no) and satisfaction (low-high = 0-10). Main outcome measure was the median % of sedentary time measured by an accelerometer worn during hospitalization and 7-14 days thereafter.
RESULTS


A total of 42 controls (mean age = 59 years, 62% male) and 52 intervention patients (58 years, 52%) were included. The exercise movie, paper information and Fitbit Flex were the three most frequently used components, with highest satisfaction scores for the fitbit, paper information, exercise movie and digital training. Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively. The difference at Day 6 reached statistical significance (difference = 41 min/day,  P  = 0.01). No differences were seen after discharge.
CONCLUSION


Implementing a multicomponent intervention to reduce sedentary time appeared feasible and may be effective during but not directly after hospitalization.",2020,"Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively.","['The study was conducted in a university hospital', 'patients admitted before and after the implementation of the intervention', 'A total of 42 controls (mean age = 59\u2009years, 62% male) and 52 intervention patients (58\u2009years, 52%) were included', 'Participants were adult patients undergoing elective organ transplantation or vascular surgery']","['digital information, an exercise movie, an activity planner, a pedometer and Fitbit Flex™, a personal activity coach and an individualized digital training program', 'multicomponent intervention']","['Median sedentary time', 'sedentary time', 'median % of sedentary time measured by an accelerometer worn during hospitalization']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0189748,"Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Conijn', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van Bodegom-Vos', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Volker', 'Affiliation': 'Department for Innovation, Quality + Research, Basalt Rehabilitation Center, The Hague/Leiden, The Netherlands.'}, {'ForeName': 'Bja', 'Initials': 'B', 'LastName': 'Mertens', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Huurman', 'Affiliation': 'Department of Transplantation Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Schaik', 'Affiliation': 'Department of Vascular Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Tpm', 'Initials': 'T', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jjl', 'Initials': 'J', 'LastName': 'Meesters', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}]",Clinical rehabilitation,['10.1177/0269215520920662']
1372,32482645,Tapering towards DMARD-free remission in established rheumatoid arthritis: 2-year results of the TARA trial.,"OBJECTIVES


To evaluate the 2-year clinical effectiveness of two gradual tapering strategies. The first strategy consisted of tapering the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate in ~90%), followed by the tumour necrosis factor inhibitor (TNF-inhibitor), the second strategy consisted of tapering the TNF-inhibitor first, followed by the csDMARD.
METHODS


This multicentre single-blinded randomised controlled trial included patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4 and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor. Eligible patients were randomised into gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa. The primary outcome was the number of disease flares. Secondary outcomes were DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression.
RESULTS


189 patients were randomly assigned to tapering their csDMARD (n=94) or TNF-inhibitor (n=95) first. The cumulative flare rate after 24 months was, respectively, 61% (95% CI 50% to 71%) and 62% (95% CI 52% to 72%). The patients who tapered their csDMARD first were more often able to go through the entire tapering protocol and reached DFR more often than the group that tapered the TNF-inhibitor first (32% vs 20% (p=0.12) and 21% vs 10% (p=0.07), respectively). Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
CONCLUSION


The order of tapering did not affect flare rates, DAS or HAQ-DI. DFR was achievable in 15% of patients with established RA, slightly more frequent in patients that first tapered csDMARDs. Because of similar effects from a clinical viewpoint, financial arguments may influence the decision to taper TNF-inhibitors first.",2020,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","['189 patients were randomly assigned to tapering their csDMARD (n=94) or', 'patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4\u2009and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor', 'Eligible patients']","['gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa', 'conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate', 'TNF-inhibitor']","['DFR', 'flare rates, DAS or HAQ-DI', 'DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression', 'cumulative flare rate', 'Mean DAS and HAQ-DI over time, and radiographic progression', 'number of disease flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",189.0,0.0797802,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217485']
1373,32490976,Baerveldt implant versus trabeculectomy as the first filtering surgery for uncontrolled primary congenital glaucoma: a randomized clinical trial.,"PURPOSE


Our initial goal was to compare the efficacy and safety of a glaucoma drainage device and trabeculectomy for children with primary congenital glaucoma after angular surgery failure. However, we discontinued the study due to the rate of complications and wrote this report to describe the results obtained with the two techniques in this particular group.
METHODS


This was a parallel, non-masked, controlled trial that included patients aged 0-13 years who had undergone previous trabeculotomy or goniotomy and presented inadequately controlled glaucoma with an intraocular pressure ≥21 mmHg on maximum tolerated medical therapy. We randomized the patients to undergo either placement of a 250-mm2 Baerveldt glaucoma implant or mitomycin-augmented trabeculectomy. The main outcome measure was intraocular pressure control. We calculated complete success (without hypotensive ocular medication) and qualified success (with medication) rates. We defined failure as uncontrolled intraocular pressure, presence of serious complications, abnormal increase in ocular dimensions, or confirmed visual acuity decrease.
RESULTS


We studied 13 eyes of 13 children (five in the glaucoma drainage device group; eight in the trabeculectomy group). Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297). None of the patients in the tube group and 37.5% of those in the trabeculectomy group achieved complete success in intraocular pressure control after 12 months of follow-up (p=0.928, Chi-square test). Two patients (40%) had serious complications at the time of tube aperture (implant extrusion, retinal detachment).
CONCLUSIONS


Both the tube and trabeculectomy groups presented similar intraocular pressure controls, but complete success was more frequent in the trabeculectomy group. Non-valved glaucoma drainage devices caused potentially blinding complications during tube opening. Because of the small sample size, we could not draw conclusions as to the safety data of the studied technique.",2020,"Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297).","['children with primary congenital glaucoma after angular surgery failure', '13 eyes of 13 children (five in the glaucoma drainage device group; eight in the trabeculectomy group', 'uncontrolled primary congenital glaucoma', 'patients aged 0-13 years who had undergone previous trabeculotomy or goniotomy and presented inadequately controlled glaucoma with an intraocular pressure ≥21 mmHg on maximum tolerated medical therapy']","['Baerveldt implant versus trabeculectomy', 'trabeculectomy', '250-mm2 Baerveldt glaucoma implant or mitomycin-augmented trabeculectomy', 'glaucoma drainage device and trabeculectomy']","['serious complications', 'intraocular pressure controls', 'complete success in intraocular pressure control', 'intraocular pressure reduction', 'efficacy and safety', 'complete success', 'ocular dimensions, or confirmed visual acuity decrease', 'intraocular pressure control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1533041', 'cui_str': 'Primary congenital glaucoma'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0040576', 'cui_str': 'Trabeculotomy'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0600545', 'cui_str': 'Baerveldt Implants'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0456786', 'cui_str': 'sq. mm'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0234632', 'cui_str': 'Reduced visual acuity'}]",13.0,0.099004,"Both surgical procedures produced a significant intraocular pressure reduction 12 months after intervention from the baseline (tube group, 22.8 ± 5.9 mmHg to 12.20 ± 4.14 mmHg, p=0.0113; trabeculectomy group, 23.7 ± 7.3 mmHg to 15.6 ± 5.9 mmHg, p=0.0297).","[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Rolim-de-Moura', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Bruno L B', 'Initials': 'BLB', 'LastName': 'Esporcatte', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'F Netto', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Paranhos', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200060']
1374,32490621,[Antiresorptive-cytokine effects of the chondroprotective therapy in patients with lower back pain].,"OBJECTIVE


To evaluate the antiresorptive-cytokine effects of chondroitin sulfate on non-specific lower back pain in patients with knee osteoarthritis (OA).
MATERIALS AND METHODS


Using the envelope method, 231 patients were randomized into two groups: group 1 ( n =116, main) received nonsteroidal anti-inflammatory drugs (NSAIDs) and chondrogard, group 2 ( n =115, comparison) received only NSAIDs. The 2-month study included 3 visits (V): V 1  - at the beginning of the study, V 2  - after 10 days, V 3  - after 60 days with the assessment of blood parameters: transforming growth factor β1 (TFR β1), interleukin (IL)-1β and IL-6, beta-Crosslaps, bone matrix formation indicator P1NP (n-terminal propeptide procollagen type 1), and determination of the level of deoxypyridinoline (DPID) in the urine.
RESULTS AND CONCLUSION


At the end of the study, there is a significant decrease in all studied cytokines in patients of group 1 compared to group 2, as well as indicators of beta-Crosslaps ( p <0,001) and DPID ( p <0,001), which may indicate the presence of its own antiresorptive-cytokine effect in chondroitin sulfate.",2020,"At the end of the study, there is a significant decrease in all studied cytokines in patients of group 1 compared to group 2, as well as indicators of beta-Crosslaps ( p <0,001) and DPID ( p <0,001), which may indicate the presence of its own antiresorptive-cytokine effect in chondroitin sulfate.","['patients with knee osteoarthritis (OA', 'patients with lower back pain', '231 patients']","['chondroprotective therapy', 'chondroitin sulfate', 'nonsteroidal anti-inflammatory drugs (NSAIDs) and chondrogard, group 2 ( n =115, comparison) received only NSAIDs']","['blood parameters: transforming growth factor β1 (TFR β1), interleukin (IL)-1β and IL-6, beta-Crosslaps, bone matrix formation indicator P1NP (n-terminal propeptide procollagen type 1), and determination of the level of deoxypyridinoline (DPID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0108801', 'cui_str': 'TFRC protein, human'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4522215', 'cui_str': 'Beta-crosslaps'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0057455', 'cui_str': 'Deoxypyridinoline'}]",231.0,0.0452325,"At the end of the study, there is a significant decrease in all studied cytokines in patients of group 1 compared to group 2, as well as indicators of beta-Crosslaps ( p <0,001) and DPID ( p <0,001), which may indicate the presence of its own antiresorptive-cytokine effect in chondroitin sulfate.","[{'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Zolotovskaya', 'Affiliation': 'Samara State Medical University, Samara, Russia.'}, {'ForeName': 'I L', 'Initials': 'IL', 'LastName': 'Davydkin', 'Affiliation': 'Samara State Medical University, Samara, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012004165']
1375,32490642,Baseline characteristics predicting clinical outcomes and serious adverse events in middle-aged hypertensive women: a subanalysis of the SPRINT in women aged <65 years,"Background/aim


The predictability of clinical outcomes in hypertension in specific patient groups, especially underrepresented populations is the key to rational treatment. This study aimed to investigate the impact of baseline characteristics of <65-year-old hypertensive women with an increased risk of cardiovascular events, managed with standard- or intensive-approach, on their clinical outcomes and serious adverse events (SAEs).
Materials and methods


Baseline characteristics of <65-year-old hypertensive women (n = 1247) in SPRINT, a multicenter randomized trial to compare standard and intensive antihypertensive treatment, were analyzed with Cox-regression method to determine potential predictors of the clinical outcomes and SAEs. The primary outcome was the composite of myocardial infarction (MI), non-MI acute coronary syndrome, stroke, heart failure, or cardiovascular death.
Results


The primary outcome occurred in 3.1% and SAEs in 27.6% of the population. The treatment groups were similar in terms of the primary outcome, SAEs, or their individual components. The primary outcome occurred significantly more in current smokers vs. nonsmokers (HR: 2.85, 95% CI: 1.34–6.09). The subjects who were on aspirin in the intensive-group were significantly more likely to develop the primary outcome (HR: 3.17, 95% CI: 1.23-8.19) and MI (HR: 10.15, 95% CI: 1.19-86.88) compared with those not using aspirin. The risk of overall SAEs was significantly higher in blacks vs. nonblacks (HR: 1.27, 95% CI: 1.01-1.58), in current-smokers vs. nonsmokers (HR: 1.59, 95% CI: 1.23-2.05), and those with vs. without chronic kidney disease (CKD), (HR: 1.38, 95% CI: 1.08-1.77). The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
Conclusion


Smoking, aspirin, CKD, black race, and age seemed as important baseline characteristics in follow-up of <65-year-old hypertensive women, also depending on therapeutic strategy. Clinicians are expected to consider these critical parameters for effective antihypertensive management that promotes better outcomes in this middle-aged female population.",2020,"The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
","['65-year-old hypertensive women with an increased risk of cardiovascular events, managed with standard- or intensive-approach', 'middle-aged hypertensive women', 'women aged <65 years', '65-year-old hypertensive women', 'Baseline characteristics of <65-year-old hypertensive women ', 'middle-aged female population']",['aspirin'],"['SAEs, or their individual components', 'risk of overall SAEs', 'composite of myocardial infarction (MI), non-MI acute coronary syndrome, stroke, heart failure, or cardiovascular death', 'current-smokers vs. non-smokers', 'likelihood of SAEs']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.264691,"The likelihood of SAEs significantly increased with age (HR: 1.04, 95% CI: 1.01-1.07).
","[{'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Aydin', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Akici', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Sakarya', 'Affiliation': 'Department of Public Health, School of Medicine, Koç University, İstanbul, Turkey'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Akman', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}, {'ForeName': 'Ali Serdar', 'Initials': 'AS', 'LastName': 'Fak', 'Affiliation': 'Hypertension and Atherosclerosis Research Center (HIPAM), Marmara University, İstanbul, Turkey'}]",Turkish journal of medical sciences,['10.3906/sag-1907-144']
1376,32485734,Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial.,"CONTEXT


Control of multiple cardiovascular (CV) risk factors reduces CV events in individuals with type 2 diabetes.
OBJECTIVE


To investigate this association in a contemporary clinical trial population, including how CV risk factor control affects the CV benefits of empagliflozin, a sodium-glucose cotransporter-2 inhibitor.
DESIGN


Post hoc analysis.
SETTING


Randomized CV outcome trial (EMPA-REG OUTCOME).
PARTICIPANTS


Type 2 diabetes patients with established CV disease.
INTERVENTION


Empagliflozin or placebo.
MAIN OUTCOME MEASURES


Risk of CV outcomes-including the treatment effect of empagliflozin-by achieving 7 goals for CV risk factor control at baseline: (1) glycated hemoglobin <7.5%, (2) low-density lipoprotein cholesterol <100 mg/dL or statin use, (3) systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, (4) pharmacological renin-angiotensin-aldosterone system blockade, (5) normoalbuminuria, (6) aspirin use, (7) nonsmoking.
RESULTS


In the placebo group, the hazard ratio (HR) for CV death was 4.00 (95% CI, 2.26-7.11) and 2.48 (95% CI, 1.52-4.06) for patients achieving only 0-3 or 4-5 risk factor goals at baseline, respectively, compared with those achieving 6-7 goals. Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]). Empagliflozin significantly reduced these outcomes across all risk factor control categories (P > 0.05 for treatment-by-subgroup interactions).
CONCLUSIONS


Cardiovascular risk in EMPA-REG OUTCOME was inversely associated with baseline CV risk factor control. Empagliflozin's cardioprotective effect was consistent regardless of multiple baseline risk factor control.",2020,"Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]).",['individuals with type 2 diabetes (T2D'],"['empagliflozin', 'Empagliflozin or placebo', 'Empagliflozin', 'EMPA', 'placebo']","['hazard ratio (HR) for CV death', 'risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke', 'risk factor control categories', 'baseline CV risk factor control', '3-point major adverse CV events', 'Risk of CV outcomes - including treatment effect of empagliflozin - by achievement of seven goals for CV risk factor control at baseline: glycated hemoglobin <7.5%, low-density lipoprotein cholesterol <100 mg/dL or statin use, systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, pharmacological renin-angiotensin-aldosterone system blockade, normoalbuminuria, aspirin use, non-smoking.\nRESULTS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.196854,"Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]).","[{'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa321']
1377,32597580,"[Efficiency and safety of phenazopyridine for treatment of uncomplicated urinary tract infection: results of multi-center, randomized, placebo-controlled, clinical study].","AIM


to evaluate the efficiency and safety of phenazopyridine for the treatment of patients with uncomplicated lower urinary tract infection, accompanied by pain.
MATERIALS AND METHODS


A multicenter double-blind, randomized, placebo-controlled study with parallel groups to evaluate the efficacy and safety of phenazopyridine in patients with acute uncomplicated cystitis was performed. A total of 60 women were divided into two groups of 30 patients. In the main group (average age 32.6+/-7.4 years) phenazopyridine was prescribed (2 tablets of 100 mg p.o., with a total dose of 200 mg, once). In the control group, patients (mean age 35.53+/-8.79 years) received a placebo according to the same scheme. To evaluate the efficiency of treatment, the severity of the main symptoms 6 hours after taking the drug was analyzed. After that, patients started antibiotic therapy. They were followed-up for the next three days. The tolerance of therapy was evaluated by the presence of adverse events.
RESULTS


All 30 patients taking phenazopyridine had an improvement after 6 hours, and the most frequent response was ""significant improvement"" (43.3%). The responses of patients in the main group significantly (p<0.05) differed from responses of patients in the control group. Six hours after taking phenazopyridine/placebo, the severity of all values according to VAS score, including the degree of general discomfort, pain during urination and increased frequency of urination improved significantly in the main group compared to the control group. The average assessment of general discomfort in the main group decreased by 53.4% in comparison with 28.8% in the control group, while the severity of pain during urination and urination frequency decreased by 57.4 vs. 35.9% and 39.6 vs. 27.6%, respectively. An analysis of the time before the complete absence of the general discomfort was performed. In the main group this period of time was significantly less than in the control group (p<0.05). There were no serious adverse events while taking phenazopyridine. Rate of adverse events was comparable between two groups.
CONCLUSION


The results of the study showed that phenazopyridine is an effective and well-tolerated drug for symptomatic therapy in patients with acute uncomplicated cystitis and can be recommended in addition to etiological therapy.",2020,In the main group this period of time was significantly less than in the control group (p<0.05).,"['patients with acute uncomplicated cystitis', 'patients with uncomplicated lower urinary tract infection, accompanied by pain', 'A total of 60 women were divided into two groups of 30 patients', 'uncomplicated urinary tract infection']","['phenazopyridine/placebo', 'phenazopyridine', 'placebo']","['VAS score', 'degree of general discomfort, pain during urination and increased frequency of urination', 'efficiency and safety', 'efficacy and safety', 'Rate of adverse events', 'average assessment of general discomfort', 'severity of pain during urination and urination frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0268821', 'cui_str': 'Lower urinary tract infectious disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0031379', 'cui_str': 'Phenazopyridine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0858924', 'cui_str': 'General discomfort'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",60.0,0.0541587,In the main group this period of time was significantly less than in the control group (p<0.05).,"[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Petrov', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Slesarevskaya', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Chibirov', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Topuzov', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'O F', 'Initials': 'OF', 'LastName': 'Kagan', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Voronova', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1378,32597582,[Prevention of infectious and inflammatory complications after percutaneous nephrolithotomy].,"INTRODUCTION


Given the increase in antibiotic resistance of uropathogens, one of the urgent problems is a development of optimal antimicrobial prophylaxis for surgical interventions, as well as an adequate regimen of antibiotic therapy after percutaneous nephrolithotomy (PCNL).
AIM


to determine an effective perioperative antimicrobial prophylaxis for PCNL in patients with kidney stones.
MATERIAL AND METHODS


A total of 90 patients with staghorn or multiple large kidney stones who underwent PCNL were included in the study. Before PCNL, urine culture was performed in all patients in order to determine the sensitivity not only to antibiotics, but also to bacteriophages. In addition, urine was taken for additional microbiological studies after the puncture of the collecting system, as well as on the 3rd and 7th day after PCNL. All patients were divided into three groups of 30 patients depending on the regimen of perioperative prophylaxis. In group 1, patients were prescribed ciprofloxacin 1000 mg i.v. intraoperatively, then 1000 mg i.v. q.d. for 3-5 days. In the group 2, patients received one dose of cefotaxime + sulbactam (1.0 g + 0.5 g) 2 hours before PCNL i.m. In the group 3, a polyvalent pyobacteriophage purified was given orally 1 hour before PCNL in a dose of 40 ml and the same dose was used t.i.d. for 3-5 days postoperatively.
RESULTS


In all three groups of patients, the following infectious complications were evaluated: acute pyelonephritis, systemic inflammatory response syndrome (SIRS) and urosepsis. There were no serious infectious and inflammatory complications in the early postoperative period among all patients. SIRS developed on days 1-3 after PCNL in 26.6%, 20% and 20% of patients in group 1, 2 and 3, respectively. However, by days 4-7 after PCNL, there was normalization of blood cells count (leukocytes, neutrophil band cells), temperature and general condition.
CONCLUSION


Different regimens of antimicrobial prophylaxis for PCNL have the same efficiency. The development of SIRS on days 1-3 after PCNL is correlated not only with the antimicrobial agents used and the route of their administration (intravenously, intramuscularly and orally). Most likely, the development of SIRS is more associated with surgical trauma.",2020,There were no serious infectious and inflammatory complications in the early postoperative period among all patients.,"['90 patients with staghorn or multiple large kidney stones who underwent PCNL were included in the study', 'patients with kidney stones']","['cefotaxime + sulbactam', 'percutaneous nephrolithotomy', 'ciprofloxacin', 'perioperative prophylaxis']","['normalization of blood cells count (leukocytes, neutrophil band cells), temperature and general condition', 'acute pyelonephritis, systemic inflammatory response syndrome (SIRS) and urosepsis', 'SIRS', 'serious infectious and inflammatory complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332249', 'cui_str': 'Staghorn'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0542518', 'cui_str': 'Large kidney'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C3661517', 'cui_str': 'Band neutrophil'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0149801', 'cui_str': 'Sepsis due to urinary tract infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",90.0,0.0553742,There were no serious infectious and inflammatory complications in the early postoperative period among all patients.,"[{'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Perepanova', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Merinov', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Kazachenko', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Khazan', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'Yu A', 'Initials': 'YA', 'LastName': 'Malova', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1379,32597584,[Method of complex therapy of chronic cystitis].,"AIM


To assess the effectiveness of hydroxyethyldimethyldihydropyrimidine (trade name Xymedone) in the treatment of chronic recurrent cystitis in women.
MATERIALS AND METHODS


The study included 30 patients (the main group) with a confirmed diagnosis of chronic cystitis (HC) with a recurrence rate of at least 3 times a year, the average age of the patients was 46.0+/-2.7 years. The control group consisted of 30 age-comparable patients with a similar diagnosis, who underwent standard treatment for this disease. The article presents the results on the effectiveness of the use of hydroxyethyldimethyldihydropyrimidine (Xymedone) in the treatment of HC after anti-inflammatory and local treatment with collargol instillations, and the terms for the regeneration of the bladder mucosa are determined. To patients of the main group Xymedone was prescribed in a dose of 500 mg 3 times a day for 30 days after the completion of local treatment. Control cystoscopy was performed 15 and 30 days after the start of the drug, 3 days after its withdrawal.
RESULTS


The planned treatment was completed by all 30 patients of the main group. After 15 days from the date of administration of Xymedone most of patients had no low urinary tract symptoms (LUTS), in comparison with the control group. Cystoscopy performed at this time allowed to establish a positive trend while taking Xymedone in the process of restoring the bladder mucosa after influence of collargol. Hyperemia in the neck and triangle area persisted in most patients, and only in 8 (26.6%) it decreased. Treatment with Xymedone was continued. After 30 days of drug intake laboratory parameters were according to normal values, a significant increase in functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination (147,9+/-26,7 ml.) was detected, the thickness of the bladder wall in a state of filling in the averages was 3.5+/- 0.3 mm, which corresponded to the norm. Cystoscopy, performed 3 days after canceling of the drug, showed a slight hyperemia in the bladder neck area only in one patient. Recurrence of HC in the control group occurred within 6 months after completion of treatment in 15 (51%) women. In the main group there were no relapses during two years of dynamic follow-up.
CONCLUSIONS


Hydroxyethyldimethyldihydropyrimidine, included in the therapy of HC, accelerates the regeneration of the bladder mucosa after local treatment of recurrent cystitis and shortens the period of its recovery, significantly lengthens the period of persistent remission.",2020,"After 30 days of drug intake laboratory parameters were according to normal values, a significant increase in functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination (147,9+/-26,7 ml.) was detected, the thickness of the bladder wall in a state of filling in the averages was 3.5+/- 0.3 mm, which corresponded to the norm.","['chronic cystitis', 'chronic recurrent cystitis in women', '30 patients (the main group) with a confirmed diagnosis of chronic cystitis (HC) with a recurrence rate of at least 3 times a year, the average age of the patients was 46.0+/-2.7 years']","['complex therapy', 'Control cystoscopy', 'hydroxyethyldimethyldihydropyrimidine (trade name Xymedone', 'Xymedone', 'hydroxyethyldimethyldihydropyrimidine (Xymedone']","['functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination', 'Hyperemia', 'Recurrence of HC']","[{'cui': 'C0221763', 'cui_str': 'Chronic cystitis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0581366', 'cui_str': 'Recurrent cystitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",30.0,0.035784,"After 30 days of drug intake laboratory parameters were according to normal values, a significant increase in functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination (147,9+/-26,7 ml.) was detected, the thickness of the bladder wall in a state of filling in the averages was 3.5+/- 0.3 mm, which corresponded to the norm.","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Sitdykova', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}, {'ForeName': 'E E', 'Initials': 'EE', 'LastName': 'Nikolsky', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Birchuk', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Sayapova', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1380,32597588,[Transurethral endopyelotomy using thulium fiber laser].,"INTRODUCTION


Transurethral endopyelotomy is an alternative treatment method for short stricture of ureteropelvic junction (UPJ).
AIM


to evaluate the efficiency of transurethral thulium laser endopyelotomy.
MATERIALS AND METHODS


A total of 94 patients with UPJ obstruction during the period from December 2016 to December 2018 were prospectively enrolled in the study. Pelvic size did not exceed 3 cm in 31 patients, and it was in the range from 3 to 4 cm and more than 4 cm in 35 and 28 cases, respectively. Depending on the treatment, all patients were divided into 2 groups. The main group included 48 patients who underwent retrograde thulium fiber laser endopyelotomy. In the control group (n = 46), patients underwent Anderson-Hynes laparoscopic pyeloplasty. In the main group, there were significantly more patients with more preserved ipsilateral kidney function, with short (less than 1 cm) and recurrent UPJ strictures and less severe hydronephrosis compared to the control group. In addition, there were no patients with crossing vessel in the main group. Postoperatively, an internal stent of 6-8 Fr was put in all patients for a period of 6-8 weeks. After stent removal, all patients underwent a follow-up examination, including an ultrasound examination and, if pelvic size was more than 3 cm, contrast-enhanced CT-urography was performed.
RESULTS


In all patients, after stent removal, a decrease in the pelvic size was noted. The operation time in the main and control group was 24+/-14 minutes and 82+/-26 minutes, respectively. In all cases, ureteropyeloscopy was performed prior to laparoscopy to determine the exact length of stricture and to exclude narrowing of other parts of the ureter. After follow-up of 24 months, an examination in 36 patients of the main group and 29 patients of the control group was performed. There was 1 recurrence after laparoscopic pyeloplasty and 1 recurrence after endopyelotomy. In other patients of both groups, there were neither stricture, nor impaired renal function.
CONCLUSION


The first experience of using a thulium fiber laser for transurethral endoscopic treatment of UPJ obstruction is presented in the article. Indications for the transurethral thulium endopyelotomy are the presence of primary or secondary UPJ obstruction (with a decrease in kidney function by no more than 40%), length of up to 1 cm, absence of an additional vessel and pelvic dilatation of no more than 4 cm.",2020,"The operation time in the main and control group was 24+/-14 minutes and 82+/-26 minutes, respectively.","['94 patients with UPJ obstruction during the period from December 2016 to December 2018 were prospectively enrolled in the study', '48 patients who underwent']","['thulium fiber laser', 'Transurethral endopyelotomy', 'retrograde thulium fiber laser endopyelotomy', 'Anderson-Hynes laparoscopic pyeloplasty', 'laparoscopic pyeloplasty', 'transurethral thulium laser endopyelotomy', 'Transurethral endopyelotomy using thulium fiber laser']","['renal function', 'recurrent UPJ strictures', 'pelvic size', 'severe hydronephrosis', 'kidney function', 'ipsilateral kidney function', 'operation time', 'Pelvic size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521619', 'cui_str': 'Obstruction of pelviureteric junction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0227680', 'cui_str': 'Structure of ureteropelvic junction'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",94.0,0.0247955,"The operation time in the main and control group was 24+/-14 minutes and 82+/-26 minutes, respectively.","[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Martov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Golubev', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Ergakov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Golubev', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Baykov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Andronov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Abdullaev', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1381,32595083,Family Mealtime Communication in Single- and Dual-Headed Households Among Hispanic Adolescents With Overweight and Obesity.,"OBJECTIVE


To investigate the association of adolescent self-report of family mealtime communication on obesity-related behaviors in single- and dual-parent households and by sex in a sample of overweight and obese Hispanic adolescents.
DESIGN


Cross-sectional analysis of a randomized control trial SETTING: Eighteen middle schools in Miami-Dade County, Florida.
PARTICIPANTS


Two-hundred and eighty Hispanic seventh- and eighth-grade students MAIN OUTCOME MEASURES: Physical activity, fruit and vegetable intake, and added sugar intake.
ANALYSIS


Structural equation modeling.
RESULTS


The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30). Moreover, a single-parent household was associated with dietary consumption in boys (fruit and vegetable intake [β= .18; P = .039; 95% CI, 0.02-2.60] but had a moderating effect on fruit and vegetable consumption in girls (β = .21; P = .015; 95% CI, 0.14-2.19).
CONCLUSIONS AND IMPLICATIONS


Family mealtime communication may impact dietary and physical activity outcomes in Hispanic adolescents with overweight and obesity, but differentially across gender and household parent makeup. These findings, together with the prevalence of single parents, point to the importance of targeting Hispanic single parents as agents of change to promote healthy lifestyle behaviors in their children via positive mealtime interactions.",2020,"The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30).","['single- and dual-parent households and by sex in a sample of overweight and obese Hispanic adolescents', 'Hispanic Adolescents With Overweight and Obesity', 'Two-hundred and eighty Hispanic seventh- and eighth-grade students', 'Eighteen middle schools in Miami-Dade County, Florida', 'Hispanic adolescents with overweight and obesity']",['family mealtime communication'],"['fruit and vegetable consumption', 'physical activity', 'Physical activity, fruit and vegetable intake, and added sugar intake', 'healthy lifestyle behaviors']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0046889', 'cui_str': ""3,3'-diallyldiethylstilbestrol""}, {'cui': 'C0016253', 'cui_str': 'Florida'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",280.0,0.0816013,"The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30).","[{'ForeName': 'Cynthia N', 'Initials': 'CN', 'LastName': 'Lebron', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL. Electronic address: Clebron@med.miami.edu.'}, {'ForeName': 'Yaray', 'Initials': 'Y', 'LastName': 'Agosto', 'Affiliation': 'Department of Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL.'}, {'ForeName': 'Tae K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Prado', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Sara M St', 'Initials': 'SMS', 'LastName': 'George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Pantin', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': ""University of Texas Health Science Center, School of Public Health, Dallas, TX; Center for Pediatric Population Health, Children's Health System of Texas and UTHealth School of Public Health, Dallas, TX.""}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.03.003']
1382,32631081,Glucose Variability and Time in Range in Type 2 Diabetes Treated with U-500R by Pump or Injection: CGM Findings from the VIVID Study .,"Background:  The E V aluating U-500R  I nfusion  V ersus  I njection in Type 2  D iabetes Mellitus (VIVID) study compared two methods of U-500R insulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI), for 26 weeks in people with type 2 diabetes (T2D) requiring high doses of insulin. To assess glycemic variability (GV) and time in range (TIR), a subset of participants performed masked continuous glucose monitoring (CGM).  Methods:  VIVID participants were adults who had insulin requirements of >200 but ≤600 U/day and A1C 7.5% to 12%. Participants performed masked CGM for seven consecutive days on each of three occasions: before weeks 0 (baseline), 14, and 26. The primary objective was to compare GV between CSII and MDI groups, based on change from baseline of within-day standard deviation (SD w ) of CGM glucose.  Results:  Of 54 participants enrolled, 41 with evaluable data were analyzed (17 and 24 in CSII and MDI groups, respectively). The CSII group had a significantly greater reduction from baseline in mean SD w  of glucose (45.0 to 38.2 mg/dL [-8.1 mg/dL]) compared with the MDI group (47.0 to 45.8 [-0.4 mg/dL];  P  = 0.047). TIR 70-180 mg/dL glucose increased significantly from baseline in the CSII group only, from 59.8% to 73.1% (change +12.9%,  P  < 0.05), but was not significantly different between groups. There were no significant between-group differences in the endpoint mean glucose or A1C.  Conclusions:  In the VIVID CGM substudy of U-500R in people with T2D requiring high doses of insulin, participants using CSII significantly reduced GV compared with MDI. CSII also significantly increased TIR with no difference between groups.",2020,The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [ 8.1 mg/dL]) compared to the MDI group (47.0 to 45.8 [-0.4 mg/dL]; p=0.047).,"['VIVID participants were adults who had insulin requirements of >200 but ≤600 U/day and A1C 7.5% to 12', 'people with type 2 diabetes (T2D) requiring high doses of insulin']","['U-500R insulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI', 'U-500R by Pump or Injection: CGM']","['dL glucose', 'Glucose Variability and Time in Range in Type', 'glycemic variability (GV) and time in range (TIR', 'mean SDw of glucose']","[{'cui': 'C1268943', 'cui_str': 'Vivid color saturation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0456683', 'cui_str': 'U/day'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",54.0,0.0718828,The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [ 8.1 mg/dL]) compared to the MDI group (47.0 to 45.8 [-0.4 mg/dL]; p=0.047).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blevins', 'Affiliation': 'Texas Diabetes and Endocrinology, Austin, Texas, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lane', 'Affiliation': 'Mountain Diabetes and Endocrine Center, Asheville, North Carolina, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodbard', 'Affiliation': 'Biomedical Informatics Consultants LLC, Potomac, Maryland, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Sindelar', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ludi', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Ellinor', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Ilag', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Ly', 'Affiliation': 'Insulet Corp., Acton, Massachusetts, USA.'}, {'ForeName': 'Jennal', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0030']
1383,32631651,A semiautomatic segmentation method for interstitial needles in intraoperative 3D transvaginal ultrasound images for high-dose-rate gynecologic brachytherapy of vaginal tumors.,"PURPOSE


The purpose of this study was to evaluate the use of a semiautomatic algorithm to simultaneously segment multiple high-dose-rate (HDR) gynecologic interstitial brachytherapy (ISBT) needles in three-dimensional (3D) transvaginal ultrasound (TVUS) images, with the aim of providing a clinically useful tool for intraoperative implant assessment.
METHODS AND MATERIALS


A needle segmentation algorithm previously developed for HDR prostate brachytherapy was adapted and extended to 3D TVUS images from gynecologic ISBT patients with vaginal tumors. Two patients were used for refining/validating the modified algorithm and five patients (8-12 needles/patient) were reserved as an unseen test data set. The images were filtered to enhance needle edges, using intensity peaks to generate feature points, and leveraged the randomized 3D Hough transform to identify candidate needle trajectories. Algorithmic segmentations were compared against manual segmentations and calculated dwell positions were evaluated.
RESULTS


All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm. The median distance between corresponding dwell positions was 0.77 mm with 86% of needles having maximum differences <3 mm. The mean segmentation time using the algorithm was <30 s/patient.
CONCLUSIONS


We successfully segmented multiple needles simultaneously in intraoperative 3D TVUS images from gynecologic HDR-ISBT patients with vaginal tumors and demonstrated the robustness of the algorithmic approach to image artifacts. This method provided accurate segmentations within a clinically efficient timeframe, providing the potential to be translated into intraoperative clinical use for implant assessment.",2020,All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm.,"['gynecologic HDR-ISBT patients with vaginal tumors', 'vaginal tumors', 'gynecologic ISBT patients with vaginal tumors']",['semiautomatic algorithm to simultaneously segment multiple high-dose-rate (HDR) gynecologic interstitial brachytherapy (ISBT) needles'],"['median distance', 'mean segmentation time']","[{'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042258', 'cui_str': 'Neoplasm of vagina'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C1881237', 'cui_str': 'Interstitial brachytherapy'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.027857,All 50 test data set needles were successfully segmented with 96% of algorithmically segmented needles having angular differences <3° compared with manually segmented needles and the maximum Euclidean distance was <2.1 mm.,"[{'ForeName': 'Jessica Robin', 'Initials': 'JR', 'LastName': 'Rodgers', 'Affiliation': 'School of Biomedical Engineering, The University of Western Ontario, London, Ontario, Canada; Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada. Electronic address: jrodge23@uwo.ca.'}, {'ForeName': 'William Thomas', 'Initials': 'WT', 'LastName': 'Hrinivich', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Surry', 'Affiliation': 'Department of Medical Physics, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Velker', 'Affiliation': 'Department of Radiation Oncology, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Radiation Oncology, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Fenster', 'Affiliation': 'School of Biomedical Engineering, The University of Western Ontario, London, Ontario, Canada; Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada.'}]",Brachytherapy,['10.1016/j.brachy.2020.05.006']
1384,32639468,"A Randomized, Controlled Pharmacokinetic and Pharmacodynamics Trial of Ambrisentan After Fontan Surgery.","OBJECTIVES


To determine the pharmacokinetics, pharmacodynamics, and safety of the hepatically metabolized endothelin receptor antagonist, ambrisentan in children after Fontan surgery.
DESIGN


Prospective, randomized, double-blind, placebo-controlled pharmacokinetic/pharmacodynamics and safety trial.
SETTING


Single-center, postoperative cardiac ICU.
PATIENTS


Children undergoing elective Fontan surgery.
INTERVENTIONS


Subjects randomized on postoperative day number 1 to short-term (3 d) treatment with oral ambrisentan (2.5 mg in suspension, daily) versus placebo (4:1 randomization).
MEASUREMENTS AND MAIN RESULTS


Plasma drug concentrations were measured at 0.5, 1, 2, 4, and 18-36 hours after the first dose. We developed a population pharmacokinetic model in NONMEM 7.2 (Icon Solutions, Ellicott City, MD) and applied the model to dose-exposure simulations. Pharmacodynamics endpoints were assessed at baseline and 3 hours after study drug administration, using postoperative hemodynamic monitoring lines. The analysis included 16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males. There were no differences in baseline characteristics between ambrisentan and controls. A one-compartment model with first-order absorption and lag-time characterized the data well. Allometrically scaled weight was the only covariate retained in the final model. Typical values for clearance and volume of distribution were lower than previously reported in adults, 1 L/hr/70 kg and 13.7 L/70 kg, respectively. Simulated exposures with doses of 0.1-0.2 mg/kg approximated therapeutic exposures in adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses. Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
CONCLUSIONS


Ambrisentan clearance is reduced following Fontan surgery, perhaps reflecting abnormal hepatic metabolism in this population. The observed safety profile appears favorable and hemodynamic effects of ambrisentan may be beneficial for Fontan patients.",2020,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","['Fontan patients', 'adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses', 'children after Fontan surgery', 'Children undergoing elective Fontan surgery', 'Single-center, postoperative cardiac ICU', '16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males']","['Ambrisentan', 'oral ambrisentan (2.5 mg in suspension, daily) versus placebo', 'placebo']","['Fontan pressures', 'Plasma drug concentrations', 'Typical values for clearance and volume of distribution', 'indexed pulmonary vascular resistance', 'plasma brain natriuretic peptide concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0918012', 'cui_str': 'Indexes as Topic'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",,0.416991,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Anil R', 'Initials': 'AR', 'LastName': 'Maharaj', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Piers C A', 'Initials': 'PCA', 'LastName': 'Barker', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002410']
1385,32639470,A Randomized Comparative Trial to Evaluate a PICU Navigator-Based Parent Support Intervention.,"OBJECTIVES


Communication breakdowns in PICUs contribute to inadequate parent support and poor post-PICU parent outcomes. No interventions supporting communication have demonstrated improvements in parental satisfaction or psychologic morbidity. We compared parent-reported outcomes from parents receiving a navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure.
DESIGN


Patient-level, randomized trial.
SETTING


Two university-based, tertiary-care children's hospital PICUs.
PARTICIPANTS


Parents of patients requiring more than 24 hours in the PICU.
INTERVENTIONS


PICU Supports included adding a trained navigator to the patient's healthcare team. Trained navigators met with parents and team members to assess and address communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and did a post-PICU discharge parent check-in. The comparator arm received an informational brochure providing information about PICU procedures, terms, and healthcare providers.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was percentage of ""excellent"" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge. Secondary outcomes included parental psychologic and physical morbidity and perceptions of team communication. We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure. Fifty-seven percent (216/382) completed the 3-5 weeks post-PICU discharge survey. The mean percentage of excellent responses to the Pediatric Family Satisfaction in the ICU 24 decision-making items was 60.4% for PICU Supports versus 56.1% for the brochure (estimate, 3.57; SE, 4.53; 95% CI, -5.77 to 12.90; p = 0.44). Differences in secondary outcomes were not statistically significant. Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively. Differences in decision-making satisfaction scores between those receiving PICU Supports and a brochure were not statistically significant. Interventions like PICU Supports should be evaluated in larger studies employing enhanced recruitment and retention of subjects.",2020,"Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively.","['We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure', ""Two university-based, tertiary-care children's hospital PICUs"", 'Parents of patients requiring more than 24 hours in the PICU']","['navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure', 'informational brochure providing information about PICU procedures, terms, and healthcare providers', 'PICU Navigator-Based Parent Support Intervention']","['percentage of ""excellent"" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge', 'Pediatric Family Satisfaction', 'decision-making satisfaction scores', 'parental psychologic and physical morbidity and perceptions of team communication', 'parental satisfaction or psychologic morbidity']","[{'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",382.0,0.172012,"Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively.","[{'ForeName': 'Kelly N', 'Initials': 'KN', 'LastName': 'Michelson', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Frader', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Charleston', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rychlik', 'Affiliation': ""Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Danica Y', 'Initials': 'DY', 'LastName': 'Aniciete', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'Division of Biostatistics, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Sorce', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Marla L', 'Initials': 'ML', 'LastName': 'Clayman', 'Affiliation': 'Health and Social Development, American Institutes for Research, Chicago, IL.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': ""Department of Pediatrics, Section of Critical Care, The University of Chicago Comer Children's Hospital, Chicago, IL.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fragen', 'Affiliation': 'Normal Moments, Chicago, IL.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Malakooti', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Derrington', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Program in Ethics and Decision Making in Critical Illness, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002378']
1386,32635281,"Influence of an Aquatic Therapy Program on Perceived Pain, Stress, and Quality of Life in Chronic Stroke Patients: A Randomized Trial.","Pain and depressive states may have a negative impact on the quality of life of individuals with stroke. The aim of this study was to evaluate the effects of a program of Ai Chi aquatic therapy on pain, depression, and quality of life in a sample of people with stroke. Forty-five participants received physiotherapy treatment on dry land (control group), an experimental group received aquatic Ai Chi therapy, and a combined therapy group received alternating sessions of physiotherapy on dry land and aquatic Ai Chi therapy. The Visual Analog Scale (VAS) scale for pain, the resilience scale, and the SF-36 quality of life scale were used as outcome measures. Statistically significant differences were found in the experimental group and the combined intervention group for post treatment pain and resilience ( p  < 0.001). Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001). In conclusion, physical exercise performed in water has positive effects on several factors that contribute towards improving the mood and quality of life of people with acquired brain injury.",2020,"Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001).","['Chronic Stroke Patients', 'people with stroke']","['Aquatic Therapy Program', 'physiotherapy treatment on dry land (control group), an experimental group received aquatic Ai Chi therapy, and a combined therapy group received alternating sessions of physiotherapy on dry land and aquatic Ai Chi therapy', 'Ai Chi aquatic therapy', 'physical exercise']","['general health, vitality, and social function', 'Perceived Pain, Stress, and Quality of Life', 'Pain and depressive states', 'mood and quality of life', 'Visual Analog Scale (VAS) scale for pain, the resilience scale, and the SF-36 quality of life scale', 'pain, depression, and quality of life']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",45.0,0.0453378,"Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001).","[{'ForeName': 'Sagrario', 'Initials': 'S', 'LastName': 'Pérez-de la Cruz', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, La Cañada de San Urbano, 04120 Almería, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134796']
1387,32635352,Everyday Pedelec Use and Its Effect on Meeting Physical Activity Guidelines.,"Pedelecs (e-bikes with electrical support up to 25 km·h -1 ) are important in active transportation. Yet, little is known about physiological responses during their everyday use. We compared daily pedelec (P) and bicycle (B) use to determine if pedelecs are a suitable tool to enhance physical activity. In 101 employees, cycling duration and intensity, heart rate (HR) during P and B were recorded via a smartphone app. Each recording period was a randomized crossover design and lasted two weeks. The ride quantity was higher in P compared to B (5.3 ± 4.3 vs. 3.2 ± 4.0 rides·wk -1 ;  p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ± 109 min·wk -1 ;  p  < 0.001). The mean HR during P was lower than B (109 ± 14 vs. 118 ± 17 bpm;  p  < 0.001). The perceived exertion was lower in P (11.7 ± 1.8 vs. 12.8 ± 2.1 in B;  p  < 0.001). The weekly energy expenditure was higher during P than B (717 ± 652 vs. 486 ± 557 metabolic equivalents of the task [MET]·min·wk -1 ;  p  < 0.01). Due to a sufficient HR increase in P, pedelecs offer a more active form of transportation to enhance physical activity.",2020,p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ±,[],[],"['total cycling time', 'weekly energy expenditure', 'ride quantity', 'perceived exertion', 'cycling duration and intensity, heart rate (HR', 'mean HR during P']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0676234,p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ±,"[{'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Boyen', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Protte', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kück', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Finkel', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17134807']
1388,32636099,Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial).,"BACKGROUND


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


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


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


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


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


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


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


There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.",2020,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"['adult men with recurrent bulbar urethral stricture', 'UK National Health Service hospitals were recruited and 222 men', 'Recurrent Bulbar Urethral Stricture', 'men with recurrent bulbar urethral stricture']","['urethrotomy and urethroplasty', 'urethrotomy with open urethroplasty', 'Urethrotomy', 'urethroplasty or urethrotomy', 'Open Urethroplasty Versus Endoscopic Urethrotomy']","['voiding symptom score', 'reinterventions', 'time until reintervention', 'voiding symptoms', 'effectiveness and cost-effectiveness', 'symptom scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0194550', 'cui_str': 'Incision of urethra'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",222.0,0.165454,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Carnell', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Breckons', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: luke.vale@ncl.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Whybrow', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rapley', 'Affiliation': 'Social Work, Education and Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Forbes', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Currer', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Andrich', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mundy', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""N'Dow"", 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'Central Manchester Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Watkin', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}]",European urology,['10.1016/j.eururo.2020.06.003']
1389,32637656,Erratum: Author Correction: A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety.,[This corrects the article DOI: 10.1038/s41746-020-0293-8.].,2020,[This corrects the article DOI: 10.1038/s41746-020-0293-8.].,['Erratum'],['digital interventions'],[],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0624127,[This corrects the article DOI: 10.1038/s41746-020-0293-8.].,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Enrique', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Eilert', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'HEDS, ScHARR, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Palacios', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Duffy', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Earley', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire England.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Jell', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire England.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sollesse', 'Affiliation': 'Berkshire Healthcare NHS Foundation Trust, London, Berkshire England.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Timulak', 'Affiliation': 'University of Dublin, Trinity College, School of Psychology, E-mental Health Research Group, Dublin, Ireland.'}]",NPJ digital medicine,['10.1038/s41746-020-0298-3']
1390,32489807,Very Early Versus Early Percutaneous Coronary Intervention in Patients with Decreased e-GFR after Successful Fibrinolytic Therapy.,"Background


Pharmacoinvasive strategy (PIS) is the alternative approach to primary percutaneous coronary intervention (PCI) if PCI capable center isn't available especially in the developing countries. Our objective of the current study was to investigate the incidence of contrast induced nephropathy (CIN), the occurrence of no reflow phenomenon and major adverse cardiac events (MACE) in patients with decreased estimated glomerular filtration rate (e-GFR) after successful fibrinolytic therapy in order to assess the benefit from very early PCI strategy (within 3-12 hours) or early PCI strategy (within 12-24 hours).
Methods


This randomized clinical trial included 420 patients with STEMI. All participants were classified randomly into two groups according to the time of intervention; Group I patients were subjected to very early PCI (within 3-12 hours) and Group II patients were subjected to early PCI (within 12-24 hours) after receiving successful fibrinolytic therapy.
Results


The incidence of CIN in Group I was slightly higher than Group II (23 patients [10.7%] versus 19 patients [9.3%]) respectively, with no statistically significant difference between the two groups (P value = 0.625). The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044. There was no statistically significant difference between the two groups regarding mortality and MACE.
Conclusion


The incidence of CIN was nearly equal in very early PCI (within 3-12 hours) versus early PCI (within 12-24 hours); however, the incidence of no-reflow phenomenon was significantly higher in patients subjected to early PCI (within 12-24 hours).",2020,"The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044.","['patients with decreased estimated glomerular filtration rate (e-GFR) after successful', 'Patients with Decreased e-GFR after Successful Fibrinolytic Therapy', '420 patients with STEMI']","['fibrinolytic therapy', 'successful fibrinolytic therapy', '\n\n\nPharmacoinvasive strategy (PIS']","['mortality and MACE', 'incidence of CIN', 'incidence of no-reflow phenomenon (TIMI 0-2 flow', 'incidence of no-reflow phenomenon']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0232347', 'cui_str': 'No reflow vascular flow'}]",420.0,0.0315396,"The incidence of no-reflow phenomenon (TIMI 0-2 flow) after the procedure was higher in Group II, while TIMI 3 flow (normal flow) was significantly higher in Group I than Group II (184 [85.6%] vs. 153 [74.6%], respectively) with P value = 0.044.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khalfallah', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}, {'ForeName': 'Randa', 'Initials': 'R', 'LastName': 'Abdelmageed', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Allaithy', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medicine, Tanta University, EG.'}]",Global heart,['10.5334/gh.794']
1391,32485550,Effects of couple conflict on alcohol craving: Does intimate partner violence play a role?,"OBJECTIVE


Social stress in the form of maladaptive relationship conflict is a common precipitant to alcohol misuse and problems. Research has also established a clear causal association between alcohol misuse and relationship conflict in the form of intimate partner violence (IPV). Despite the robust literature linking relationship conflict and problematic drinking using survey methodology, no laboratory studies have examined the proximal association between relationship conflict and alcohol craving among couples, or the influence of IPV perpetration and victimization on this association.
METHOD


As part of a larger randomized controlled trial, 30 different-sex community couples with substance misuse completed a laboratory conflict resolution task. Participants reported subjective alcohol craving on a Likert-type scale immediately, before, and after the task. Conflict behaviors were coded by trained observers. Analyses were conducted using a multilevel modeling framework to account for the dyadic nature of the data.
RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only. Contrary to our hypotheses, no main or moderating effects of conflict behaviors, IPV perpetration, or IPV victimization were found for women.
CONCLUSIONS


Findings from this exploratory study suggest that in this sample, relationship conflict and IPV in one's current relationship played a more impactful role on acute alcohol craving among men compared to women. Future studies should examine the role of specific conflict behaviors on alcohol craving and relapse risk, and patterns of communication that might increase or reduce risk for exacerbated alcohol craving.",2020,"RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.",['30 different-sex community couples with substance misuse completed a laboratory conflict resolution task'],['couple conflict'],"['subjective alcohol craving', 'negative and positive conflict behaviors and alcohol craving', 'conflict behaviors, IPV perpetration, or IPV victimization', 'acute alcohol craving', 'alcohol craving', 'Conflict behaviors']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.0159769,"RESULTS


Findings indicate that psychological and physical IPV perpetration and victimization strengthened the associations between negative and positive conflict behaviors and alcohol craving among men only.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, United States. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President St, Charleston, SC 29425, United States.'}, {'ForeName': 'Ruschelle M', 'Initials': 'RM', 'LastName': 'Leone', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Oesterle', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States; Department of Health Policy & Behavioral Sciences, School of Public Health, Georgia State University, P.O. Box 3995, Atlanta, GA 30302, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106474']
1392,32581275,Publisher Correction: Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['individuals with prehypertension or hypertension'],"['Publisher Correction', 'exercise training modalities']",['endothelial function improvements'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0456419,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-67586-2']
1393,32589455,Virtual Reality Aids Game Navigation: Evidence from the Hypertext Lostness Measure.,"Instead of traditional free movement, node-based movement can be used in virtual reality (VR) games. In node-based movement systems, players navigate by jumping to set locations. Node-based movement is similar to hypertext navigation. We show that the hypertext lostness measure can be used as a game analytic to evaluate navigational efficiency. In a randomized controlled trial with 25 adolescent participants, an immersive desktop game environment and a VR game environment were compared on the transmission of in-game educational content and navigational efficiency. Results show that the hypertext lostness measure is also valuable outside its original hypertext domain: in VR. VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency. We conclude (a) the hypertext lostness measure is also valuable for node-based VR games and (b) VR games add to spatial learning, even when compared with already immersive desktop games.",2020,"VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency.",['25 adolescent participants'],['immersive desktop game environment and a VR game environment'],"[""players' spatial knowledge and navigational efficiency"", ""players' retention of factual knowledge""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",25.0,0.0146821,"VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ferguson', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Egon L', 'Initials': 'EL', 'LastName': 'van den Broek', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Herre', 'Initials': 'H', 'LastName': 'van Oostendorp', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'de Redelijkheid', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Giezeman', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2019.0435']
1394,32591439,"Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment: The Systolic Blood Pressure Intervention Trial.","BACKGROUND


Intensively treating hypertension may benefit cardiovascular disease and cognitive function, but at the short-term expense of reduced kidney function.
METHODS


We investigated markers of kidney function and the effect of intensive hypertension treatment on incidence of dementia and mild cognitive impairment (MCI) in 9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively). We categorized participants according to baseline and longitudinal changes in eGFR and urinary albumin-to-creatinine ratio. Primary outcomes were occurrence of adjudicated probable dementia and MCI.
RESULTS


Among 8563 participants who completed at least one cognitive assessment during follow-up (median 5.1 years), probable dementia occurred in 325 (3.8%) and MCI in 640 (7.6%) participants. In multivariable adjusted analyses, there was no significant association between baseline eGFR <60 ml/min per 1.73 m 2  and risk for dementia or MCI. In time-varying analyses, eGFR decline ≥30% was associated with a higher risk for probable dementia. Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI. Although these kidney events occurred more frequently in the intensive treatment group, there was no evidence that they modified or attenuated the effect of intensive treatment on dementia and MCI incidence. Baseline and incident urinary ACR ≥30 mg/g were not associated with probable dementia or MCI, nor did the urinary ACR modify the effect of intensive treatment on cognitive outcomes.
CONCLUSIONS


Among hypertensive adults, declining kidney function measured by eGFR is associated with increased risk for probable dementia and MCI, independent of the intensity of hypertension treatment.",2020,Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI.,"['hypertensive adults', '8563 participants who completed at least one', 'Kidney Disease, Intensive Hypertension Treatment, and Risk for Dementia and Mild Cognitive Impairment', '9361 participants in the randomized Systolic Blood Pressure Intervention Trial, which compared intensive versus standard systolic BP lowering (targeting <120 mm Hg versus <140 mm Hg, respectively']",['intensive hypertension treatment'],"['incidence of dementia and mild cognitive impairment (MCI', 'eGFR and urinary albumin-to-creatinine ratio', 'dementia and MCI incidence', 'cognitive assessment', 'kidney events', 'probable dementia', 'occurrence of adjudicated probable dementia and MCI']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",9361.0,0.140303,Incident eGFR <60 ml/min per 1.73 m 2  was associated with a higher risk for MCI and a composite of dementia or MCI.,"[{'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Kurella Tamura', 'Affiliation': 'Geriatric Research and Education Clinical Center, Palo Alto VA Health Care System, Palo Alto, California mktamura@stanford.edu.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Gordon J', 'Initials': 'GJ', 'LastName': 'Chelune', 'Affiliation': ""Center for Alzheimer's Care, Imaging and Research, University of Utah School of Medicine, Salt Lake City, Utah.""}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Section of Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Departments of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Vascular Biology and Hypertension Program, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dena E', 'Initials': 'DE', 'LastName': 'Rifkin', 'Affiliation': 'Division of Nephrology, University of California San Diego, San Diego, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Supiano', 'Affiliation': 'Division of Geriatrics, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Sticht Center for Healthy Aging and Alzheimer's Prevention and Division of Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.""}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020010038']
1395,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE


To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM).
METHODS


A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated.
RESULTS


Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
CONCLUSIONS


The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024']
1396,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE


To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK).
METHOD


The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting.
RESULTS


The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed.
CONCLUSION


Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005']
1397,32594273,Protective effect of the oral administration of cystine and theanine on oxaliplatin-induced peripheral neuropathy: a pilot randomized trial.,"BACKGROUND


Oxaliplatin, one of the key cytotoxic drugs for colorectal cancer, frequently causes peripheral neuropathy which leads to dose modification and decreased patients' quality of life. However, prophylactic or therapeutic measures have not yet been established. Orally administered amino acids, cystine and theanine, promoted the synthesis of glutathione which was one of the potential candidates for preventing the neuropathy. The aim of this study was to determine whether daily oral administration of cystine and theanine attenuated oxaliplatin-induced peripheral neuropathy (OXLIPN).
METHODS


Twenty-eight colorectal cancer patients who received infusional 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) therapy were randomly and evenly assigned to the cystine and theanine group and the control group. OXLIPN was assessed up to the sixth course using original 7-item questionnaire as well as Common Terminology Criteria for Adverse Events (CTCAE) grading scale.
RESULTS


Neuropathy scores according to our original questionnaire were significantly smaller in the cystine and theanine group at the fourth (p = 0.026), fifth (p = 0.029), and sixth course (p = 0.038). Furthermore, significant differences were also observed in CTCAE neuropathy grades at the fourth (p = 0.037) and the sixth course (p = 0.017). There was one patient in each group who required dose reduction due to OXLIPN. Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin.
CONCLUSION


The results demonstrated the daily oral administration of cystine and theanine attenuated OXLIPN.",2020,"Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin.
","['Twenty-eight colorectal cancer patients who received', 'induced peripheral neuropathy']","['oxaliplatin', 'cystine and theanine attenuated oxaliplatin', 'infusional 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) therapy', 'amino acids, cystine and theanine', 'cystine and theanine', 'Oxaliplatin', 'cystine and theanine group and the control group']","['Neuropathy scores', 'total amount of administered oxaliplatin', 'neurotoxicity', 'OXLIPN', 'CTCAE neuropathy grades', 'incidence of adverse events']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.0213027,"Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin.
","[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Ryuichiro', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Komura', 'Affiliation': 'Department of Surgery, Omagari Kousei Medical Center, Akita, Akita, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Hirashima', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otake', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Akazawa', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yazawa', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Takaho', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kakita', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Oikawa', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan. tsuchiya@openhp.or.jp.'}]",International journal of clinical oncology,['10.1007/s10147-020-01728-4']
1398,32600452,Development of a multivariable improvement measure for gout.,"BACKGROUND


Gout is a heterogeneous inflammatory disease with numerous clinical manifestations. A composite means to assess the impact of therapy on numerous aspects of gout could be useful.
METHODS


Results from patients treated with pegloticase or placebo in two randomized clinical trials and their open-label extension were assessed using a novel evidence-based Gout Multivariable Improvement Measure (GMIM) derived from previously reported criteria for remission and complete response. Improvement was defined as serum urate (sU) < 6 mg/dL and absence of flares during the preceding 3 months plus 20, 50, and 70% improvement in tophus size, patient global assessment, pain, and swollen and tender joints.
RESULTS


Patients treated with pegloticase manifested a significantly greater GMIM20, 50, and 70 response vs those treated with placebo (GMIM20 at 6 months 37.1% vs 0%, respectively). Higher response rates were significantly more frequent in subjects with persistent urate lowering (GMIM 58.1% at 6 months) in response to pegloticase versus those with only transient urate lowering (GMIM 7.1% at 6 months). However, when the requirement for a decrease in sU to < 6 mg/dL was omitted, a substantial percentage of subjects with transient urate lowering met the GMIM clinical criteria. A sensitivity analysis indicated that gout flares contributed minimally to the model. The response measured by GMIM persisted into the open-level extension for as long as 2 years. Finally, subjects who received placebo in the randomized control trials, but pegloticase in the open-label extension, manifested GMIM responses comparable to that noted with pegloticase-treated subjects in the randomized controlled trials.
CONCLUSIONS


GMIM captures changes in disease activity in response to treatment with pegloticase and may serve as an evidence-based tool for assessment of responses to other urate-lowering therapies in gout patients.",2020,Higher response rates were significantly more frequent in subjects with persistent urate lowering (GMIM 58.1% at 6 months) in response to pegloticase versus those with only transient urate lowering (GMIM 7.1% at 6 months).,['gout patients'],"['pegloticase or placebo', 'placebo']","['tophus size, patient global assessment, pain, and swollen and tender joints', 'GMIM responses', 'Higher response rates', 'serum urate (sU', 'GMIM20']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2350656', 'cui_str': 'Pegloticase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0221248', 'cui_str': 'Tophus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}]",,0.181673,Higher response rates were significantly more frequent in subjects with persistent urate lowering (GMIM 58.1% at 6 months) in response to pegloticase versus those with only transient urate lowering (GMIM 7.1% at 6 months).,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Schlesinger', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'N Lawrence', 'Initials': 'NL', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Yeo', 'Affiliation': 'Yeo Analytics, LLC, Jersey City, NJ, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Lipsky', 'Affiliation': 'AMPEL BioSolutions, LLC, Charlottesville, VA, USA. peterlipsky@comcast.net.'}]",Arthritis research & therapy,['10.1186/s13075-020-02254-4']
1399,32601816,Correction to: The Protective Effects of Butorphanol on Pulmonary Function of Patients with Obesity Undergoing Laparoscopic Bariatric Surgery: A Double-Blind Randomized Controlled Trial.,In the original article some of the references were ordered incorrectly.,2020,In the original article some of the references were ordered incorrectly.,['Patients with Obesity Undergoing Laparoscopic Bariatric Surgery'],['Butorphanol'],['Pulmonary Function'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",,0.375577,In the original article some of the references were ordered incorrectly.,"[{'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiao-Xiao', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xing-He', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China. w15996933165@163.com.'}]",Obesity surgery,['10.1007/s11695-020-04821-9']
1400,32598234,Acute Effects of Weighted Baseball Throwing Programs on Shoulder Range of Motion.,"BACKGROUND


Baseball pitching injuries are increasing at an alarming rate. While weighted ball throwing programs may be effective at increasing pitching velocity, previous research has identified a 24% injury rate and a 3.3° increase in shoulder external rotation (ER) range of motion (ROM) after performing a 6-week program. However, previous research has not investigated, separately, the immediate effects of throwing underloaded and overloaded balls on ROM. The purpose of this study was to examine the acute effects of throwing differently weighted baseballs on shoulder ROM. By analyzing these differences, it may be possible to determine the specific weight range that may lead to the greatest increase in ROM and potential injury risk.
HYPOTHESIS


Throwing with weighted balls will result in an increase in shoulder ER ROM.
STUDY DESIGN


Randomized controlled trial.
LEVEL OF EVIDENCE


Level 2.
METHODS


A total of 16 male high school baseball pitchers agreed to participate in this study. The participants were (mean ± SD) 17.1 ± 1.0 years of age, 1.81 ± 0.09 m tall, and had a mass of 79.2 ± 11.1 kg. Each participant was tested on 3 different days, 1 week apart, with 3 different conditions in random order: (1) underload throwing, using regulation 5-oz baseballs and 4- and 2-oz balls; (2) overload throwing, using 5-, 6-, and 9-oz balls; and (3) extreme overload throwing, using 5-, 16-, and 32-oz balls. Each testing session began by measuring passive shoulder ROM (external rotation and internal rotation) using standard goniometric measurements. Participants then performed 3 throws with each weighted ball from 3 different positions (kneeling, rocker, and run-and-gun) for a total of 27 throws each test session. ROM measurements were repeated at the end of each test session. The effect of each throwing condition on ROM was compared from pre- to posttraining using a paired  t  test ( P  ≤ 0.05).
RESULTS


There was no significant difference in ER after throwing at underloaded weights. The overload condition showed a statistically significant increase of 3.3° in external rotation ( P  = 0.05). The extreme overload condition showed a statistically significant increase in ER of 8.4° ( P  < 0.001). There were no differences in internal rotation for any group.
CONCLUSION


A significant increase in shoulder ER was observed immediately after throwing overload weighted balls. This effect increased as the weights of the balls increased.
CLINICAL RELEVANCE


Throwing with overload weighted baseballs causes an immediate increase in shoulder ER ROM. It is unknown why these changes occur; however, the results may explain both the increase in velocity and injury rates previously observed from throwing weighted balls. The current study results may be used to develop more scientifically validated weighted ball programs. Heavier balls should be used with caution, and ROM should be monitored during implementation of these programs.",2020,The overload condition showed a statistically significant increase of 3.3° in external rotation ( P  = 0.05).,"['16 male high school baseball pitchers', 'The participants were (mean ± SD) 17.1 ± 1.0 years of age, 1.81 ± 0.09 m tall, and had a mass of 79.2 ± 11.1 kg']","['Weighted Baseball Throwing Programs', 'underload throwing, using regulation 5-oz baseballs and 4- and 2-oz balls; (2) overload throwing, using 5-, 6-, and 9-oz balls; and (3) extreme overload throwing, using 5-, 16-, and 32-oz balls']","['ROM', 'shoulder external rotation (ER) range of motion (ROM', 'weights of the balls increased', 'internal rotation', 'external rotation', 'Shoulder Range of Motion', 'ER', 'velocity and injury rates', 'shoulder ER ROM', 'shoulder ER', 'ROM measurements']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",16.0,0.0570077,The overload condition showed a statistically significant increase of 3.3° in external rotation ( P  = 0.05).,"[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Reinold', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Leonard C', 'Initials': 'LC', 'LastName': 'Macrina', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Fleisig', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Drogosz', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Andrews Sports Medicine and Orthopaedic Center, Birmingham, Alabama.'}]",Sports health,['10.1177/1941738120925728']
1401,32598699,[Clinical efficacy of mechanical bacterial lysate in the prevention of infectious exacerbations of chronic obstructive pulmonary disease].,"AIM


To evaluate the efficacy of mechanical bacterial lysate on the prevention of infectious exacerbations of chronic obstructive pulmonary disease in patients with frequent exacerbations.
MATERIALS AND METHODS


The study included patients (n=60) with frequent exacerbations of COPD (groups C and D according to the GOLD classification). All COPD patients were divided into two groups by blind method. The first group (n=30) received conventional therapy for COPD plus MBL (the course included 3 cycles of 10 days therapy with 20-day intervals between them). The second group of patients (control, n=30) received conventional therapy for COPD without MBL.We evaluated the severity of symptoms, frequency of recurrence of COPD exacerbations, readmissions, need for emergency care and changes in basic therapy of COPD. Evaluations were done on 10 days, 1, 3 and 6 months from the start of the study.
RESULTS


Adding of MBL to the therapy list of COPD resulted in a significant decrease of biomarkers of systemic inflammation and sputum purulence during compared to the control group. After 6 months of observation MBL group demonstrated statistically significant improvement of respiratory function, decrease in frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD. Therapy with MBL showed a high degree of safety and low incidence of adverse events.
CONCLUSION


The results of the study indicate that MBL may be used for the prevention of severe infectious exacerbations of COPD.",2020,"After 6 months of observation MBL group demonstrated statistically significant improvement of respiratory function, decrease in frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD.","['chronic obstructive pulmonary disease', 'All COPD patients', 'patients (n=60) with frequent exacerbations of COPD (groups C and D according to the GOLD classification', 'patients with frequent exacerbations']","['MBL', 'conventional therapy for COPD plus MBL', 'conventional therapy for COPD without MBL.We', 'mechanical bacterial lysate']","['chronic obstructive pulmonary disease', 'respiratory function', 'frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD', 'severity of symptoms, frequency of recurrence of COPD exacerbations, readmissions, need for emergency care and changes in basic therapy of COPD', 'biomarkers of systemic inflammation and sputum purulence']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0854358', 'cui_str': 'Purulence'}]",60.0,0.0349951,"After 6 months of observation MBL group demonstrated statistically significant improvement of respiratory function, decrease in frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD.","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Avdeev', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Nuralieva', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Gainitdinova', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Baimakanova', 'Affiliation': 'Loginov Moscow Clinical Scientific Center.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'So', 'Affiliation': 'Military Medical Academy.'}, {'ForeName': 'Z M', 'Initials': 'ZM', 'LastName': 'Merzhoeva', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.04.000590']
1402,32598700,[Comparison of clinical-metabolic efficacy of pre- and probiotics in the conducted optimized protocols of eradication therapy of Helicobacter pylori infection].,"Low patient compliance due to the development of adverse events in the form of antibiotic-associated diarrhea (AAD) is considered as the main reason for the failure of the eradication of optimized anti-Helicobacter therapy regimens. A key mechanism for the development of AAD is to reduce the number and species diversity of bacteria that form butyric acid.
AIM


The purpose of this study was to study the comparative effect on the clinical effectiveness of eradication therapy (ET) of Helicobacter pylori infection and metabolic changes in the colon microbiota of additional inclusion in the optimized treatment regimen of the combined prebiotic Zakofalk (inulin + butyrate) with probiotics (lacto- and bifidobacteria in an amount of at least 1017 СFU).
MATERIALS AND METHODS


120 patients with chronic gastroduodenal diseases and infected H. pylori were еxamined. A comparative analysis of the effect of a combined prebiotic and lacto-bifid-containing probiotics on improving the effectiveness of the optimized ET scheme and improving its tolerability, as well as on the quantitative and qualitative content of short-chain fatty acids (SFA) in feces. The success of eradication was controlled by a 13C urease breath test.
RESULTS


According to the results of the study in randomized groups of patients, an excellent percentage of eradication (95%) was achieved in patients who performed ET with the addition of the prebiotic Zakofalk. In the same group of patients, there was an increase in the absolute content of SFA and a significant increase in the concentration of butyric acid. In the group of patients who received ET with the addition of probiotics, an acceptable level of eradication was achieved (85.7%), but no changes in SFA were found indicating an increase in the number or activity of the butyrate-producing flora. Patients who performed ET without the addition of pre-probiotics did not achieve the target percentage of successful eradication (83.3%), and a significant quantitative decrease in SFA was found with a significant decrease in the proportion of butyric acid.
CONCLUSION


The inclusion of Zakofalk in the ET scheme, in comparison with probiotics, significantly increases the probability of successful eradication, more effectively restores the metabolic potential of the microbiota, and prevents the development of AAD.",2020,"In the same group of patients, there was an increase in the absolute content of SFA and a significant increase in the concentration of butyric acid.","['120 patients with chronic gastroduodenal diseases and infected H. pylori were еxamined', 'Helicobacter pylori infection']","['combined prebiotic and lacto-bifid-containing probiotics', 'pre- and probiotics', 'eradication therapy (ET', 'combined prebiotic Zakofalk (inulin + butyrate) with probiotics (lacto- and bifidobacteria']","['acceptable level of eradication', 'number or activity of the butyrate-producing flora', 'probability of successful eradication', 'successful eradication', 'concentration of butyric acid', 'absolute content of SFA', 'proportion of butyric acid', 'success of eradication']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0443152', 'cui_str': 'Bifid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}]",120.0,0.0258875,"In the same group of patients, there was an increase in the absolute content of SFA and a significant increase in the concentration of butyric acid.","[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Butorova', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Ardatskaya', 'Affiliation': 'Central State Medical Academy of the President of the Russian Federation.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Osadchuk', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Kadnikova', 'Affiliation': 'Central Clinical Hospital for Rehabilitation Treatment.'}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Lukianova', 'Affiliation': 'City Polyclinic №201.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Plavnik', 'Affiliation': 'ISOCARB LLC.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Sayutina', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Topchiy', 'Affiliation': 'Central State Medical Academy of the President of the Russian Federation.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Tuayeva', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.04.000647']
1403,32598811,[Possibilities of cardioselective beta - blocker bisoprolol therapy in patients having coronary artery disease and bronchial asthma].,"AIM


to compare the antianginal and pulse slowing effects, the impact on the ectopic myocardial activity as well as the safety of the treatment with beta - adrenoblocker bisoprolol, calcium antagonist verapamil and the combination of bisoprolol with amlodipine in patients with stable angina (SA) and bronchial asthma (BA).
MATERIALS AND METHODS


The study included 90 patients with SA II-III functional class (FC) having concomitant persistent asthma of moderate severity, controlled, without exacerbation. The patients were divided into three groups with 30 individuals in each one depending on the main antianginal drug prescribed. Group 1 patients received a cardio - selective beta - adrenergic blocker bisoprolol (Concor) at the dose of 5 mg/day, patients of group 2 were treated by a calcium antagonist verapamil at the dose of 240 mg/day, patients of group 3 received combined therapy with bisoprolol at the dose of 5 mg/day and amlodipine at the dose of 5 mg/day given as a fixed combination (Concor AM 5/5). All the patients were investigated by the methods of daily ECG monitoring and respiratory function study (RFS) in addition to physical examination at baseline and after 4 weeks of treatment.
RESULTS


After 4 weeks of treatment, patients of group 1 and group 3 did not complain of angina attacks and did not use nitroglycerin unlike patients of group 2. The achieved heart rate (HR) in group 1 patients was 68.6±8.5 beats/min, in group 2 - 74.3±5.6 beats/min, in group 3 - 67.3±4.8 beats/min. A significant decrease in the number of supraventricular and ventricular extrasystoles occurred in patients of group 1 and group 3 only. Thus, the pulse slowing, antianginal, antiischemic and antiarrhythmic effect of the calcium antagonist verapamil, even at the dose of 240 mg/day, is not always sufficient for the patients with SA II-III FC and concomitant BA, unlike therapy with the inclusion of beta - blocker bisoprolol. During the study there was no registered deterioration in the indices of bronchial patency according to the RFS data in the patients of all three groups.
CONCLUSION


In patients with coronary artery disease and concomitant asthma, all three types of pulse slowing therapy do not have any negative effects on bronchial patency. Therapy with the inclusion of beta - blockers (bisoprolol or its combination with amlodipine), in contrast to verapamil, reliably reduces heart rate and the number of supraventricular and ventricular extrasystoles in addition to a good antianginal effect.",2019,A significant decrease in the number of supraventricular and ventricular extrasystoles occurred in patients of group 1 and group 3 only.,"['patients with coronary artery disease and concomitant asthma', 'patients having coronary artery disease and bronchial asthma', 'patients with stable angina (SA) and bronchial asthma (BA', '90 patients with SA II-III functional class (FC) having concomitant persistent asthma of moderate severity, controlled, without exacerbation']","['calcium antagonist verapamil', 'verapamil', 'beta - adrenoblocker bisoprolol, calcium antagonist verapamil', 'cardioselective beta - blocker bisoprolol therapy', 'beta - blockers (bisoprolol or its combination with amlodipine', 'bisoprolol with amlodipine', 'combined therapy with bisoprolol at the dose of 5 mg/day and amlodipine', 'nitroglycerin', 'cardio - selective beta - adrenergic blocker bisoprolol (Concor']","['complain of angina attacks', 'heart rate and the number of supraventricular and ventricular extrasystoles', 'heart rate (HR', 'bronchial patency', 'number of supraventricular and ventricular extrasystoles', 'pulse slowing, antianginal, antiischemic and antiarrhythmic effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0304516', 'cui_str': 'Beta-1 adrenergic receptor antagonist'}, {'cui': 'C3698199', 'cui_str': 'Bisoprolol therapy'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0110591', 'cui_str': 'Concor'}]","[{'cui': 'C0235462', 'cui_str': 'Anginal attack'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",90.0,0.0164006,A significant decrease in the number of supraventricular and ventricular extrasystoles occurred in patients of group 1 and group 3 only.,"[{'ForeName': 'N Y', 'Initials': 'NY', 'LastName': 'Grigorieva', 'Affiliation': 'Privolzhsky Research Medical University.'}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Ilyushina', 'Affiliation': 'Privolzhsky Research Medical University.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Yashina', 'Affiliation': 'Privolzhsky Research Medical University.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000268']
1404,32598812,[Comparative efficacy and safety of enoxaparin followed by warfarin and rivaroxaban monotherapy in the treatment of venous thrombosis in patients after intracardiac catheter interventions].,"AIM


to compare two anticoagulant therapy (ACT) regimens in the treatment of venous thrombosis (VT) in patients after catheter interventions - electrophysiological studies (EFIs) and ablations: enoxaparin followed by warfarin, and rivaroxaban monotherapy.
MATERIALS AND METHODS


The study included patients from 18 years and older with heart rhythm disorders and planned catheter ablation. When parietal venous thrombosis (VT) were detected at the femoral vein puncture site, all patients were randomly assigned to two treatment groups. In group I enoxaparin 1 mg/kg was prescribed every 12 hours with switching to warfarin after 7 days with maintenance of the target INR values (2.0-3.0). In group II rivaroxaban therapy was started at a dose of 15 mg twise/day for 21 days with a further transition to a dose of 20 mg/day. The total period of observation and treatment of patients was at least 3 months.
RESULTS


408 patients were observed, 42 (10.3%) patients with parietal VT were divided into two treatment groups. In group I (n=16) complete lysis of VT was noted by the 7th day of treatment in 7 (58.3%) patients, however this scheme was associated with a greater risk of complications (р=0.003) at the puncture site in the form of arteriovenous fistulae (n=1; 8.3%) and intermuscular hematomas (n=4; 25%). In group II (n=26), no complications were noted, the lysis time of VT was on average 21 days (n=18; 69.2%). Complete lysis of VT was noted in both groups at the time of the control observation point (3rd month).
CONCLUSION


The efficiency of the two VT treatment regimens was comparable. Enoxaparin therapy is associated with a high risk of local complications, namely intermuscular hematomas (n=4; 25%) and arteriovenous fistulas (n=1; 8.3%). Rivaroxaban monotherapy is safer (p=0.003); in Group II none of the patients had any complications.",2019,Rivaroxaban monotherapy is safer (p=0.003); in Group II none of the patients had any complications.,"['patients after intracardiac catheter interventions', 'patients after catheter interventions - electrophysiological studies (EFIs) and ablations', '408 patients were observed, 42 (10.3%) patients with parietal VT', 'patients from 18 years and older with heart rhythm disorders and planned catheter ablation']","['Rivaroxaban monotherapy', 'enoxaparin followed by warfarin, and rivaroxaban monotherapy', 'warfarin and rivaroxaban monotherapy', 'anticoagulant therapy (ACT', 'Enoxaparin', 'rivaroxaban', 'enoxaparin']","['lysis time of VT', 'complete lysis of VT', 'Complete lysis of VT', 'venous thrombosis', 'intermuscular hematomas', 'risk of complications', 'venous thrombosis (VT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0179724', 'cui_str': 'Cardiac catheter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}]","[{'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0554597', 'cui_str': 'Intermuscular hematoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",408.0,0.0304219,Rivaroxaban monotherapy is safer (p=0.003); in Group II none of the patients had any complications.,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Loginova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Kropacheva', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Maykov', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Balakhonova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Golitsyn', 'Affiliation': 'National Medical Research Center of Cardiology.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000282']
1405,32608120,Effect of recorded maternal voice on emergence agitation in children undergoing bilateral ophthalmic surgery: A randomised controlled trial.,"AIM


This study was designed to investigate whether the playing-back of the recorded maternal voice through the headphones to children undergoing bilateral ophthalmic surgery has clinical effects on the incidence of emergence agitation, and the anaesthesia recovery course.
METHODS


In this prospective, blinded and randomised study, 127 children, aged 2-8 years and undergoing bilateral ophthalmic surgery were randomly allocated to one of the two groups: group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli). The primary outcome was the incidence of emergence agitation, and the secondary outcomes were the awakening time, and the post-anaesthesia care unit (PACU) stay time.
RESULTS


Children in the group of listening recorded mother's voice exhibited significantly low incidence of emergence agitation compared with those in the control group (32.8 vs. 55.6%; odds ratio (95% confidence interval): 0.39(0.19-0.80); P = 0.010). The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048). As results, the group T had significantly less PACU stay time with early discharge than the group C did (29.7 (12.1) vs. 34.8 (14.1); P = 0.031).
CONCLUSIONS


Recorded mother's voice is an efficient method to reduce emergence agitation in children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia. Also, patients woke faster and PACU stay time was shorter in the mother's voice group as compared with the control group.",2020,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"['children undergoing bilateral ophthalmic surgery', '127 children, aged 2-8\u2009years and undergoing bilateral ophthalmic surgery', 'children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia']","[""group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli"", 'recorded maternal voice']","['awakening time, and the post-anaesthesia care unit (PACU) stay time', 'emergence agitation', 'awakening time', 'PACU stay time with early discharge', 'PACU stay time', 'incidence of emergence agitation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",127.0,0.285404,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ma-Zhong', 'Initials': 'MZ', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zhe-Zhe', 'Initials': 'ZZ', 'LastName': 'Peng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Pei-Pei', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ji-Jian', 'Initials': 'JJ', 'LastName': 'Zheng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jun-Zheng', 'Initials': 'JZ', 'LastName': 'Wu', 'Affiliation': ""Department of Anaesthesia and Paediatrics, Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio, United States.""}]",Journal of paediatrics and child health,['10.1111/jpc.14948']
1406,32640554,Psychological and Physiological Responses in Patients with Generalized Anxiety Disorder: The Use of Acute Exercise and Virtual Reality Environment.,"Virtual exercise therapy is considered a useful method by which to encourage patients with generalized anxiety disorder (GAD) to engage in aerobic exercise in order to reduce stress. This study was intended to explore the psychological and physiological responses of patients with GAD after cycling in a virtual environment containing natural images. Seventy-seven participants with GAD were recruited in the present study and randomly assigned to a virtual nature (VN) or a virtual abstract painting (VAP) group. Their electroencephalogram alpha activity, perceived stress, and levels of restorative quality and satisfaction were assessed at baseline and after an acute bout of 20 min of moderate-intensity aerobic exercise. The results showed that both the VN and VAP groups showed significantly higher alpha activity post-exercise as compared to pre-exercise. The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction. These findings imply that a virtual exercise environment is an effective way to induce a relaxing effect in patients with GAD. However, they exhibited more positive psychological responses when exercising in such an environment with natural landscapes.",2020,"The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction.","['Seventy-seven participants with GAD', 'Patients with Generalized Anxiety Disorder', 'patients with GAD', 'patients with GAD after cycling in a virtual environment containing natural images', 'patients with generalized anxiety disorder (GAD']","['VAP', 'virtual nature (VN) or a virtual abstract painting (VAP', 'Acute Exercise and Virtual Reality Environment', 'Virtual exercise therapy', 'virtual exercise environment']","['alpha activity post-exercise', 'Psychological and Physiological Responses', 'positive psychological responses', 'stress-relief, restorative quality, and personal satisfaction', 'electroencephalogram alpha activity, perceived stress, and levels of restorative quality and satisfaction']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031206', 'cui_str': 'Personal wellbeing status'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",77.0,0.0381468,"The VN group relative to the VAP group exhibited higher levels of stress-relief, restorative quality, and personal satisfaction.","[{'ForeName': 'Tsai-Chiao', 'Initials': 'TC', 'LastName': 'Wang', 'Affiliation': 'Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University, Tainan 701, Taiwan.'}, {'ForeName': 'Cindy Hui-Ping', 'Initials': 'CH', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ta-Wei', 'Initials': 'TW', 'LastName': 'Tang', 'Affiliation': 'Department of Leisure and Recreation Management, Asia University, Taichung 413, Taiwan.'}, {'ForeName': 'Chia-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University, Tainan 701, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17134855']
1407,32640602,"Efficacy of a Six-Week Dispersed Wingate-Cycle Training Protocol on Peak Aerobic Power, Leg Strength, Insulin Sensitivity, Blood Lipids and Quality of Life in Healthy Adults.","BACKGROUND


The aim of this study was to evaluate the efficacy of a six-week dispersed Wingate Anaerobic test (WAnT) cycle exercise training protocol on peak aerobic power (VO 2peak ), isokinetic leg strength, insulin sensitivity, lipid profile and quality of life, in healthy adults.  Methods : We conducted a match-controlled cohort trial and participants were assigned to either the training (intervention, INT,  N  = 16) or non-training (control, CON,  N  = 17) group. INT performed 30-s WAnT bouts three times a day in the morning, afternoon and evening with each bout separated by ~4 h of rest, performed for 3 days a week for 6 weeks. Criterion measures of peak oxygen uptake (VO 2peak ), leg strength, insulin markers such as homeostatic model assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI), blood lipids profile and health-related quality of life (HRQL) survey were assessed before and after 6 weeks in both groups.  Results : Absolute VO 2peak  increased by 8.3 ± 7.0% ( p  < 0.001) after INT  vs . 0.9 ± 6.1% in CON ( p  = 0.41) group. Maximal voluntary contraction at 30°·s -1  of the dominant lower-limb flexors in INT increased significantly post-training ( p  = 0.03). There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  Conclusion s : The results indicate that 6 weeks of dispersed sprint cycle training increased cardiorespiratory fitness and dynamic leg strength but had minimal impact on insulin sensitivity, blood lipids and quality of life in the exercising individuals.",2020,"There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  ","['Healthy Adults', 'healthy adults']","['Six-Week Dispersed Wingate-Cycle Training Protocol', 'training (intervention, INT,  N  = 16) or non-training (control, CON,  N  = 17) group', 'dispersed sprint cycle training', 'CON', 'six-week dispersed Wingate Anaerobic test (WAnT) cycle exercise training protocol']","['Peak Aerobic Power, Leg Strength, Insulin Sensitivity, Blood Lipids and Quality of Life', 'peak oxygen uptake (VO 2peak ), leg strength, insulin markers such as homeostatic model assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI), blood lipids profile and health-related quality of life (HRQL) survey', 'cardiorespiratory fitness and dynamic leg strength', 'peak aerobic power (VO 2peak ), isokinetic leg strength, insulin sensitivity, lipid profile and quality of life', 'cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures', 'insulin sensitivity, blood lipids and quality of life', 'Absolute VO 2peak', 'Maximal voluntary contraction']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",,0.019415,"There were no changes in the INT individuals' other cardiorespiratory markers, HOMA, QUICKI, blood lipids, and HRQL measures (all  p  > 0.05) between pre- and post-training; but importantly, no differences were observed between INT and CON groups (all  p  > 0.05).  ","[{'ForeName': 'Chun Hou', 'Initials': 'CH', 'LastName': 'Wun', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore.'}, {'ForeName': 'Mandy Jiajia', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': 'Changi Sports Medicine Centre, Changi General Hospital, Singapore 529889, Singapore.'}, {'ForeName': 'Boon Hor', 'Initials': 'BH', 'LastName': 'Ho', 'Affiliation': 'Changi Sports Medicine Centre, Changi General Hospital, Singapore 529889, Singapore.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'McGeough', 'Affiliation': 'ActiveSG, Active Health Division, Sport Singapore, Singapore 397630, Singapore.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Tan', 'Affiliation': 'Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore.'}, {'ForeName': 'Abdul Rashid', 'Initials': 'AR', 'LastName': 'Aziz', 'Affiliation': 'Sport Science and Sport Medicine, Singapore Sport Institute, Sport Singapore, Singapore 397630, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17134860']
1408,32642278,Erratum to laparoscopic needle catheter jejunostomy by using a double semipurse string suture method in minimally invasive Ivor Lewis esophagectomy.,[This corrects the article DOI: 10.21037/jtd.2020.01.53.].,2020,[This corrects the article DOI: 10.21037/jtd.2020.01.53.].,['minimally invasive Ivor Lewis esophagectomy'],['laparoscopic needle catheter jejunostomy'],[],"[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0491233', 'cui_str': 'Needle catheter'}, {'cui': 'C0022377', 'cui_str': 'Creation of jejunostomy'}]",[],,0.0288503,[This corrects the article DOI: 10.21037/jtd.2020.01.53.].,"[{'ForeName': 'Xuyang', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Thyroid and Breast Surgery, Lishui Hospital of Zhejiang University, Lishui Municipal Central Hospital, Lishui 323000, China.'}, {'ForeName': 'Zixiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Tianwei', 'Initials': 'T', 'LastName': 'Zhan', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China.'}]",Journal of thoracic disease,['10.21037/jtd-2020-53']
1409,32585700,Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2.,"STUDY OBJECTIVES


To assess long-term efficacy and safety of lemborexant (LEM), a novel dual orexin receptor antagonist, versus placebo in adults with insomnia disorder.
METHODS


This was a 12-month, global, multicenter, randomized, double-blind, parallel-group phase 3 study comprising a 6-month placebo-controlled period (reported here) followed by a 6-month active-treatment-only period (reported separately). A total of 949 participants with insomnia (age ≥18 years) were randomized, received treatment with an oral dose of placebo or LEM (5 mg [LEM5] or 10 mg [LEM10]) and were analyzed. Sleep onset and sleep maintenance endpoints were analyzed from daily electronic sleep diary data. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.
RESULTS


Decreases from baseline in patient-reported (subjective) sleep onset latency and subjective wake after sleep onset, and increases from baseline in subjective sleep efficiency, were significantly greater with LEM5 and LEM10 versus placebo. Significant benefits over placebo were observed at the end of month 6, and at most time points assessed over the 6-month period, indicating long-term sustained efficacy of LEM. A significantly greater percentage of sleep onset responders and sleep maintenance responders were observed with LEM treatment versus placebo. Participants treated with LEM reported a significant improvement in quality of sleep after 6 months versus placebo. The majority of TEAEs were mild or moderate. There was a low rate of serious TEAEs and no deaths.
CONCLUSIONS


LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.",2020,"CONCLUSIONS


LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.","['949 participants with insomnia (age ≥18 years', 'adults with insomnia disorder', 'individuals with insomnia disorder versus']","['placebo or LEM (5 mg [LEM5] or 10 mg [LEM10', 'LEM', 'LEM5 and LEM10', 'lemborexant (LEM', 'lemborexant', 'placebo']","['quality of sleep', 'percentage of sleep onset responders and sleep maintenance responders', 'subjective sleep efficiency', 'sleep onset and sleep maintenance', 'tolerated', 'Sleep onset and sleep maintenance endpoints', 'low rate of serious TEAEs and no deaths']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",949.0,0.47688,"CONCLUSIONS


LEM5 and LEM10 provided significant benefit on sleep onset and sleep maintenance in individuals with insomnia disorder versus placebo, and was well tolerated.","[{'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kärppä', 'Affiliation': 'Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Yardley', 'Affiliation': 'Eisai Co., Ltd., Hatfield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pinner', 'Affiliation': 'Eisai Co., Ltd., Hatfield, UK.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, NY.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kubota', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}]",Sleep,['10.1093/sleep/zsaa123']
1410,32586939,Clinical Significance of Circulating Tumor Cells in Hormone Receptor-positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab.,"PURPOSE


We evaluated the prognostic and predictive value of circulating tumor cells (CTCs) hormone receptor-positive (HR + ) metastatic breast cancer (MBC) patients randomized to letrozole alone or letrozole plus bevacizumab in the first-line setting (CALGB 40503).
EXPERIMENTAL DESIGN


Blood samples were collected at pretreatment and three additional time points during therapy. The presence of ≥5 CTCs per 7.5 mL of blood was considered CTC positive. Association of CTCs with progression-free survival (PFS) and overall survival (OS) was assessed using Cox regression models.
RESULTS


Of 343 patients treated, 294 had CTC data and were included in this analysis. Median follow-up was 39 months. In multivariable analysis, CTC-positive patients at baseline (31%) had significantly reduced PFS [HR, 1.49; 95% confidence interval (CI), 1.12-1.97] and OS (HR, 2.08; 95% CI, 1.49-2.93) compared with CTC negative. Failure to clear CTCs during treatment was associated with significantly increased risk of progression (HR, 2.2; 95% CI, 1.58-3.07) and death (HR, 3.4; 95% CI, 2.36-4.88). CTC-positive patients who received only letrozole had the worse PFS (HR, 2.3; 95% CI, 1.54-3.47) and OS (HR, 2.6; 95% CI, 1.59-4.40). Median PFS in CTC-positive patients was significantly longer (18.0 vs. 7.0 months) in letrozole plus bevacizumab versus letrozole arm ( P  = 0.0009). Restricted mean survival time analysis further revealed that addition of bevacizumab was associated with PFS benefit in both CTC-positive and CTC-negative patients, but OS benefit was only observed in CTC-positive patients.
CONCLUSIONS


CTCs were highly prognostic for the addition of bevacizumab to first-line letrozole in patients with HR+ MBC in CALGB 40503. Further research to determine the potential predictive value of CTCs in this setting is warranted.",2020,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"['hormone receptor-positive metastatic breast cancer patients who received', 'CTC-positive patients who received', '343 patients treated, 294 had CTC data and were included in this analysis', 'patients with HR+ MBC']","['letrozole with or without bevacizumab', 'letrozole (Let) alone or letrozole plus bevacizumab (Let+Bev']","['OS benefit', 'Median PFS', 'PFS', 'death', 'Association of CTCs with progression-free survival (PFS) and overall survival (OS', 'risk of progression', 'worse PFS']","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.146634,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"[{'ForeName': 'Mark Jesus M', 'Initials': 'MJM', 'LastName': 'Magbanua', 'Affiliation': 'University of California at San Francisco, San Francisco, California. mark.magbanua@ucsf.edu.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Savenkov', 'Affiliation': 'Weill Medical College of Cornell University, New York, New York.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Asmus', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Alliance Statistics and Data Center, Weill Medical College of Cornell University, New York, New York.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Scott', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Dickler', 'Affiliation': 'Lilly Oncology, Indianapolis, Indiana.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1329']
1411,32587333,Author Correction: Low-molecular-weight-heparin increases Th1- and Th17-associated chemokine levels during pregnancy in women with unexplained recurrent pregnancy loss: a randomised controlled trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['women with unexplained recurrent pregnancy loss'],[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}]",[],[],,0.173116,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'E Rasmark', 'Initials': 'ER', 'LastName': 'Roepke', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö and Lund University, Lund, Sweden. emma_36@hotmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bruno', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nedstrand', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boij', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C Petersson', 'Initials': 'CP', 'LastName': 'Strid', 'Affiliation': 'Departmen of Obstetrics and Gynecology, Kalmar Hospital, Kalmar, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piccione', 'Affiliation': 'Section of Gynecology and Obstetrics, Academic Department of Biomedicine and Prevention, and Clinical Department of Surgery, Tor Vergata University Hospital, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Svensson-Arvelund', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-020-67807-8']
1412,32587371,Author Correction: A Randomised Controlled Trial on the Effectiveness and Adherence of Modified Alternate-day Calorie Restriction in Improving Activity of Non-Alcoholic Fatty Liver Disease.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"['Author Correction', 'Non-Alcoholic Fatty Liver Disease']",['Modified Alternate-day Calorie Restriction'],[],"[{'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",[],,0.0995565,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Muhammad Izzad', 'Initials': 'MI', 'LastName': 'Johari', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairiah', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Juhara', 'Initials': 'J', 'LastName': 'Haron', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Chandran', 'Initials': 'C', 'LastName': 'Nadarajan', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairun Nisah', 'Initials': 'KN', 'LastName': 'Ibrahim', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Muhammad Ilham Abdul', 'Initials': 'MIA', 'LastName': 'Hafidz', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Bee Eng', 'Initials': 'BE', 'LastName': 'Chua', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Nurhazwani', 'Initials': 'N', 'LastName': 'Hamid', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Wan Nor', 'Initials': 'WN', 'LastName': 'Arifin', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia. yylee@usm.my.'}]",Scientific reports,['10.1038/s41598-020-67806-9']
1413,32589129,"Prospective partially randomized comparison of clopidogrel loading versus maintenance dosing to prevent periprocedural myocardial infarction after stenting for stable angina pectoris: Results from the ""Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients (MECCA)"" study.","WHAT IS KNOWN AND OBJECTIVE


Pre-treatment of clopidogrel 600 mg is better than 300 mg loading for reducing periprocedural myocardial infarction (PMI). We aimed to evaluate pre-treatment methods for preventing PMI among patients undergoing conventional coronary angiography (CAG) for stable angina pectoris.
MATERIALS AND METHODS


The study analyzed 402 patients who underwent percutaneous coronary intervention (PCI) during 2010 - 2011 at three Korean hospitals. Clopidogrel-naïve patients received routine maintenance therapy (75 mg/day for ≥ 5 days) and were randomly assigned to a 300-mg reload (RL) or only the maintenance dose (MD). Patients who received a loading dose (LD; 600 mg at 2 - 24 hours before the procedure) were entered into a non-randomized group.
RESULTS


After excluding patients who showed an abnormal creatinine kinase myocardial band (CK-MB) level, the study included 233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group. The LD group had a significantly higher rate of PMI (LD: 21, RL: 3, MD: 0 cases; p = 0.007) and a significant increase in the mean CK-MB levels after 8 hours (p = 0.016) and 24 h (p = 0.01). However, there was no difference in PMI between the RL and MD groups. Furthermore, no significant differences between the three groups were observed in the P2Y12 reaction unit (PRU) values (p = 0.57). Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days.
WHAT IS NEW AND CONCLUSION


Clopidogrel maintenance is better than 600-mg loading for preventing PMI, and the RL protocol did not further prevent PMI.",2020,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days.
","['233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group', 'patients undergoing', '402 patients who underwent percutaneous coronary intervention (PCI) during 2010\xa0-\xa02011 at three Korean hospitals', 'stable angina pectoris']","['clopidogrel loading', 'conventional coronary angiography (CAG', '300-mg reload (RL) or only the maintenance dose (MD', 'clopidogrel', 'Clopidogrel-naïve patients received routine maintenance therapy', 'Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram']","['rate of PMI', 'rate of moderate-to-severe GUSTO bleeding', 'periprocedural myocardial infarction', 'P2Y12 reaction unit (PRU) values', 'periprocedural myocardial infarction (PMI', 'mean CK-MB levels', 'PMI', 'abnormal creatinine kinase myocardial band (CK-MB) level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0740471', 'cui_str': 'Creatinine abnormal NOS'}]",233.0,0.0456417,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days.
","[{'ForeName': 'Jae Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Je Sang', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Kyung Joo', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Joo', 'Affiliation': ''}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Do-Sun', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203644']
1414,32593779,Aspirin for the prevention of placenta-mediated complications in pregnant women with chronic hypertension.,"Chronic hypertension affects 1-5% of women of childbearing age. During pregnancy, chronic hypertension is associated with an increased risk of vascular disease such as superimposed preeclampsia (PE), intrauterine growth retardation (IUGR), placental abruption, and preterm delivery. These serious and frequent pathologies, specific to pregnancy, carry a particularly high risk of maternal complications (HELLP syndrome, eclampsia, maternal death) and perinatal complications (perinatal death, neurological disorders). To date, there is no curative treatment of vascular complications of chronic hypertension during pregnancy. The only effective treatment, once the complications are established, is usually stopping the pregnancy and delivering the placenta. Some recommendations suggest the use of low dose aspirin in the prevention of these complications. Although the efficacy of low-dose aspirin is assumed in patients with previous preeclampsia, few studies have evaluated its efficacy in patients with chronic hypertension. Controlled prospective studies using very low doses of aspirin (less than 100 mg) and started after 15 weeks of gestation do not seem conclusive. The objective of this work is first to detail the complications of chronic hypertension during pregnancy, then to analyze the studies which evaluated the interest of low dose aspirin in prevention of the placental vascular complications of the pregnancy in patients with chronic hypertension. We also propose an update on the European and North American national recommendations for the prevention of preeclampsia by low dose aspirin in the high-risk population of patients with chronic hypertension. Finally we present the CHASAP (Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy) trial (NCT04356326), a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).",2020,"a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).","['pregnant women with chronic hypertension', 'patients with previous preeclampsia', '150\u2009mg/day) with a', 'patients with chronic hypertension']","['aspirin', 'placebo']","['Chronic hypertension', 'maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",,0.0912185,"a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lecarpentier', 'Affiliation': 'University Paris Est Créteil and CHI Créteil, Créteil, France; Department of Obstetrics Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haddad', 'Affiliation': 'University Paris Est Créteil and CHI Créteil, Créteil, France; Department of Obstetrics Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, France. Electronic address: Bassam.Haddad@chicreteil.fr.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101845']
1415,32602000,Contrast-enhanced ultrasonography and blue dye methods in detection of sentinel lymph nodes following neoadjuvant chemotherapy in initially node positive breast cancer.,"BACKGROUND


Recent studies show that contrast-enhanced ultrasonography (CEUS) using SonoVue has the potential to improve the performance of sentinel lymph node biopsy (SLNB) in patients with early breast cancer. However, the evidence of SLNB using CEUS in patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC) is lacking. The aim of this prospective study is to evaluate the feasibility of CEUS using SonoVue for the identification of sentinel lymph node (SLN) and the value of the combination of CEUS and blue dye (BD) for SLNB in patients converting from cN1 to cN0 following NAC.
METHODS


Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC. Patients converting from cN1 to cN0 following NAC were enrolled and randomized into two groups for SLNB: the combination method group using CEUS and BD together, and the single BD method group. Then all patients underwent complete axillary lymph node dissection (ALND) and primary breast surgery. Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
RESULTS


A total of 400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5%) patients had clinically negative node confirmed by imaging after NAC and randomized into two groups. Each group included 67 cases. In the combination method group, contrast-enhanced lymphatic vessels in 66 cases of 67 were clearly visualized by US soon after the periareolar injection of SonoVue and the SLNs were accurately localized. The identification rate of the combination method was 98.5%%, which was significantly higher than 83.6% (56/67) using the single BD method. The mean numbers of SLNs identified by the combination method was higher than that by the single BD method. Compared with pathological diagnosis, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method were 84.4%, 100%, 89.4%, 100%, 75%, and 15.6%, respectively. In contrast, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR using single blue dye were 73.9%, 100%, 89.3%, 100%, 84.6%, and 26.1%, respectively. The FNR using the combination method was significantly lower than that using single BD.
CONCLUSION


Identification of SLNs in patients converting from cN1 to cN0 following NAC by CEUS is a technically feasible. The combination of CEUS and BD is more effective than BD alone for SLNB in patients converting from cN1 to cN0 following NAC.",2020,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
","['initially node positive breast cancer', '400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5', 'Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC', 'patients converting from cN1 to cN0 following NAC', 'Patients converting from cN1 to cN0 following NAC', 'patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC', 'patients with early breast cancer']","['SLNB: the combination method group using CEUS', 'CEUS', 'CEUS and BD', 'CEUS and blue dye (BD', 'complete axillary lymph node dissection (ALND) and primary breast surgery', 'Contrast-enhanced ultrasonography and blue dye methods', 'neoadjuvant chemotherapy', 'contrast-enhanced ultrasonography (CEUS']","['identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value', 'mean numbers of SLNs', 'sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method', 'sensitivity, specificity, accuracy, the positive predictive value']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",400.0,0.0388999,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods.
","[{'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Breast Surgical Oncology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, No. 420 Fuma Road, Fuzhou, 350014, Fujian, People's Republic of China. wxf200104@hotmail.com.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Shixin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': ""Department of Clinical Laboratory, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': ""Department of Pathology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05646-8']
1416,32598630,[Treatment of influenza and other acute respiratory viral infections in patients with diabetes mellitus].,"PURPOSE OF THE STUDY


The study of the influenza and ARVI clinical performance, the development of patients with diabetes mellitus, evaluation of the effectiveness and safety application of antiviral therapy, carried out in the framework of routine clinical practice.
MATERIALS AND METHODS


126 patients aged from 22 to 83 years (27.8% of men) with ARVI or influenza that occurred with medical care during the first 5 days of the disease (60.3% in the first 48 hours) are included. All patients suffer from diabetes, for the treatment of which oral hypoglycemic agents or insulins were constantly taken. The patients were divided into two groups: the first group received standard symptomatic treatment of ARVI; antiviral drug Kagocel.
RESULTS AND CONCLUSION


Diabetes and other acute respiratory viral infections. There is an increase in the incidence of bacterial complications - 2.2 times, an increase in the frequency of systemic antibiotics - 2.3 times. The purpose of the drug prescription led to a more rapid regression of all the symptoms of influenza and ARVI, but the most striking positive dynamics was observed in the symptoms of general weakness and headache. The prescription of Kagocel was accompanied by a 58% reduction in the number of bacterial complications and a 53% reduction in the use of antibiotics, which led to a reduction in the number of cases of the disease and an improvement in initial diseases, with an frequency increase in 1.8 times. The most significant effect achieved with early treatment and early initiation of antiviral therapy (in the first 48 hours of the disease).",2019,"There is an increase in the incidence of bacterial complications - 2.2 times, an increase in the frequency of systemic antibiotics - 2.3 times.","['126 patients aged from 22 to 83 years (27.8% of men) with ARVI or influenza that occurred with medical care during the first 5 days of the disease (60.3% in the first 48 hours) are included', 'patients with diabetes mellitus', 'All patients suffer from diabetes, for the treatment of which oral hypoglycemic agents or insulins were constantly taken']",['standard symptomatic treatment of ARVI; antiviral drug Kagocel'],"['early initiation of antiviral therapy', 'number of bacterial complications']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",126.0,0.0171877,"There is an increase in the incidence of bacterial complications - 2.2 times, an increase in the frequency of systemic antibiotics - 2.3 times.","[{'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Sitnikov', 'Affiliation': 'Yaroslavl State Medical University.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Fazylov', 'Affiliation': 'Kazan State Medical University.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Silina', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.10.000333']
1417,32598657,[Impact of endothelial dysfunction on the course of acute ST-elevation myocardial infarction and its correction by remote ischemic preconditioning].,"Aim of the study - to assess the effect of remote ischemic preconditioning (RIPC) on the incidence of endothelial dysfunction (ED) and its impact on hospital prognosis in patients with ST segment elevation acute myocardial infarction (STEMI).
MATERIALS AND METHODS


We conducted a single - centre, open - label prospective study that included 173 patients with STEMI who underwent primary percutaneous coronary intervention within the first 24 hours of the symptoms onset. Before the PCI, patients were randomized into two groups. In the first group (n=86) during the preparation for PCI, we performed RIPC procedure by inflation of the cuff of the tonometer to 200 mm Hg and its further deflation on patient's shoulder, thus creating short cycles of controlled ischemia/reperfusion in hand (4 cycles of ischemia/reperfusion for 5/5 minutes respectively). In the second, control group (n=87), the standard primary PCI was performed without the previous RIPC. Evaluation of the endothelial function was performed on the 2-7th day after admission using the endothelium - dependent flow - mediated dilatation test (FMD) of the brachial artery. Primary endpoints in this study included the presence of ED, in - hospital mortality, life - threatening arrhythmias (ventricular fibrillation/ventricular tachycardia after first 24 hours upon admission), stent thrombosis, clinical signs of heart failure, and a combined endpoint consisting of all the listed above.
RESULTS


The median values for FMD-test did not differ significantly between the study groups upon admission. Assessment of the FMD of the brachial artery on the 2-7th day after PCI showed that among the patients who underwent RIPC there was a significantly lower percentage of patients with ED than in the patients with STEMI who did not undergo RIPC before PCI (43.1% vs. 75.8% respectively, p=0.0001). We found a significant reduction in the incidence of heart failure and of combined endpoint in the group of patients without ED compared with patients with ED: 0% vs. 9.3% (n=7; p=0.023) and 3.8% (n=2) vs. 16% (n=12; p=0.032) respectively. When assessing the effect of RIPC on hospital prognosis, we also found a significant decrease in the incidence of heart failure and a trend towards a decrease in the combined endpoint in the group of patients who underwent RIPC compared to the control group: 1.5% (n=1) vs. 9.7% (n=6; p=0.045) and 6.2% (n=4) vs. 16.1% (n=10; p=0.073) respectively.
CONCLUSION


Performance of RIPC before the primary PCI significantly reduces the incidence of ED in patients with STEMI on the 2-7th day of the disease onset. The presence of ED in patients with STEMI is associated with a significant increase in the incidence of heart failure and of the combined endpoint during in - hospital period. RIPC significantly reduces the incidence of heart failure in patients with STEMI during in - hospital period.",2020,We found a significant reduction in the incidence of heart failure and of combined endpoint in the group of patients without ED compared with patients with ED: 0% vs. 9.3% (n=7; p=0.023) and 3.8% (n=2) vs. 16% (n=12; p=0.032) respectively.,"['patients with ST segment elevation acute myocardial infarction (STEMI', '173 patients with STEMI who underwent primary percutaneous coronary intervention within the first 24 hours of the symptoms onset']","['RIPC', 'remote ischemic preconditioning (RIPC']","['endothelial function', 'median values for FMD-test', 'incidence of ED', 'presence of ED, in - hospital mortality, life - threatening arrhythmias (ventricular fibrillation/ventricular tachycardia after first 24 hours upon admission), stent thrombosis, clinical signs of heart failure, and a combined endpoint consisting of all the listed above', 'endothelial dysfunction (ED', 'incidence of heart failure', 'FMD of the brachial artery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}]",173.0,0.04097,We found a significant reduction in the incidence of heart failure and of combined endpoint in the group of patients without ED compared with patients with ED: 0% vs. 9.3% (n=7; p=0.023) and 3.8% (n=2) vs. 16% (n=12; p=0.032) respectively.,"[{'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Manchurov', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Lebedeva', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Ryazankina', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'E Y', 'Initials': 'EY', 'LastName': 'Vasilieva', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Shpektor', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.01.000140']
1418,32598663,[Assessment of the clinical efficacy of telemonitoring and distant counseling in patients with uncontrolled hypertension].,"The aim of the study was to investigate the mathematical correlation of the clinical efficacy of blood pressure telemonitoring and distant counseling (BPTM) in patients in uncontrolled hypertension (HTN). Telehealth tools are widely used in HTN management. However clinical efficacy of such interventions assessed mainly in groups investigated without its populational and attributable impact. Materials and methods. The total of 240 patients were included, then randomized in 2:1 manner to BPTM group (n=160, median age 47 y.o.) and control group (n=80, median age 49 y.o). The user - friendly and secure telehealth software was provided with mobile application (patients) and desktop (doctors) platforms which allowed storage and analysis of self-BP monitoring data and remote consultations. A three - month surveillance was designed with mandatory baseline and final face - to - face visits with the assessment of office systolic BP (oSBP). Mathematical evaluation was based on target SBP rates achieved in comparator groups and included the absolute efficacies (AE), the attributable efficacy (AtE), the relative efficacy (RE) and the population attributable efficacy (PAtE). Results. BPTM group characterized by larger decrease in SBP level compared with controls (-16.8±2.9 mm Hg versus -7.9±3.9 mm Hg; p.",2020,BPTM group characterized by larger decrease in SBP level compared with controls (-16.8±2.9 mm Hg versus -7.9±3.9 mm Hg;,"['240 patients were included, then randomized in 2:1 manner to BPTM group (n=160, median age 47 y.o.) and control group (n=80, median age 49 y.o', 'patients in uncontrolled hypertension (HTN', 'patients with uncontrolled hypertension']","['telemonitoring and distant counseling', 'blood pressure telemonitoring and distant counseling (BPTM']","['SBP level', 'relative efficacy (RE', 'SBP rates']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",240.0,0.0331739,BPTM group characterized by larger decrease in SBP level compared with controls (-16.8±2.9 mm Hg versus -7.9±3.9 mm Hg;,"[{'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Ionov', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Zhukova', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education ""Privolzhsky Research Medical University"".'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Zvartau', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Kurapeev', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Yudina', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Konradi', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.01.000481']
1419,32599496,Randomized controlled three-arm study of NADA acupuncture for alcohol addiction.,"INTRODUCTION


Alcohol addiction compromises cardiovascular health, possibly due to impaired control of the heart and vasculature by the autonomic nervous system. We aimed to assess the effects of National Acupuncture Detoxification Association (NADA) acupuncture on cardiovascular autonomic functions, psychiatric comorbidities and abstinence in patients addicted to alcohol.
MATERIAL AND METHODS


A randomized sham controlled three-arm study was undertaken in 72 patients (nine females, aged 43.7 ± 9.2 years, mean ± SD) undergoing in-patient rehabilitation for alcohol addiction. Patients were randomly allocated (1:1:1) to receive twenty 30-minute NADA or sham acupuncture sessions within six weeks or no intervention. They were evaluated for craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response). Testing was performed at baseline, immediately post intervention (sham intervention or control period, respectively) and another four weeks later. Abstinence was assessed one year after study completion.
RESULTS


Patients in the NADA arm displayed increased HRV immediately post-intervention compared to baseline (SDNN: 72.8 ms ± 34.2 ms vs. 57.9 ms ± 31.2 ms, p = 0.001). This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015). HRV remained unaltered following sham or no acupuncture (p = n.s.). Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence did not differ between study arms.
CONCLUSIONS


NADA acupuncture may improve autonomic cardiac function. However, this improvement appears not to translate into alleviation of psychiatric comorbidities or sustained abstinence.",2020,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","['patients addicted to alcohol', '72 patients (nine females, aged 43.7\xa0±\xa09.2\xa0years, mean\xa0±\xa0SD) undergoing in-patient rehabilitation for alcohol addiction', '34.2']","['NADA or sham acupuncture sessions within six weeks or no intervention', 'National Acupuncture Detoxification Association (NADA) acupuncture', 'sham or no acupuncture', 'NADA acupuncture']","['HRV', 'Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence', 'craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response', 'autonomic cardiac function', 'cardiovascular autonomic functions, psychiatric comorbidities and abstinence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C5191359', 'cui_str': '34.2'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0038989', 'cui_str': 'Sweat gland structure'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",72.0,0.09429,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krause', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Penzlin', 'Affiliation': 'Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ritschel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Barlinn', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Reichmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Weidner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siepmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Siepmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. Electronic address: timo.siepmann@ukdd.de.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106488']
1420,32605881,Reducing metabolic syndrome through a community-based lifestyle intervention in African American women.,"BACKGROUND AND AIMS


Metabolic syndrome (MetS) increases the risk of cardiovascular disease and type 2 diabetes. Despite a higher prevalence of MetS in African American (AA) women, little is known about the effectiveness of lifestyle interventions in improving metabolic markers in this high-risk group. This study investigated the effectiveness of a community-based lifestyle intervention delivered by lay health coaches in reducing MetS among AA women.
METHODS AND RESULTS


A cluster-randomized diabetes prevention program (DPP) was implemented in 11 churches utilizing a community-based participatory research (CBPR) approach to develop and deliver the interventions. A total of 221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study. The prevalence of MetS was 42.08% before receiving the DPP intervention and 31.22% after the intervention that represented a 10.86% absolute reduction and a 25.81% relative reduction from baseline. The adjusted odds ratio (OR) of being free from MetS at post-intervention in contrast to baseline was 2.14 (p = 0.02). Factors that increased the odds of being free from MetS were younger age, reduction in intake of total calories, total fat, saturated and trans-fat, and dietary sodium.
CONCLUSION


A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese. Findings from this study can be used to translate evidence into public health programs at the community level for the prevention of type 2 diabetes and cardiovascular disease.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04082702 (www.clinicaltrials.gov).",2020,A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese.,"['African American (AA) women', 'AA women', 'African American women', '11 churches utilizing a community-based participatory research (CBPR', '221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study', 'AA women who were overweight or obese']","['diabetes prevention program (DPP', 'community-based lifestyle intervention']","['adjusted odds ratio (OR) of being free from MetS', 'prevalence of MetS']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",221.0,0.0456853,A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA. Electronic address: abdullah.mamun@bswhealth.org.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA; University of North Texas Health Science Center, Fort Worth, TX, USA; Baylor University, Waco, TX, USA.'}, {'ForeName': 'Leilani', 'Initials': 'L', 'LastName': 'Dodgen', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, TX, USA; University of North Texas Health Science Center, Fort Worth, TX, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.005']
1421,32605885,Functional pasta consumption in healthy volunteers modulates ABCG1-mediated cholesterol efflux capacity of HDL.,"BACKGROUNDS AND AIMS


Prevention of cardiovascular (CV) disease is considered a central issue in public health and great attention is payed to nutritional approaches, including consumption of functional foods to reduce CV risk in individuals without indications for anti-atherosclerotic drugs. Cholesterol efflux capacity (CEC) is an important anti-atherogenic property of HDL and a marker of CV risk. We evaluated the effect of a daily consumption of an innovative whole-wheat synbiotic pasta, compared to a control whole-wheat pasta, on serum ATP binding cassette G1 (ABCG1)-mediated CEC in healthy overweight or obese individuals.
METHODS AND RESULTS


Study participants (n = 41) were randomly allocated to either innovative or control pasta, consumed daily for twelve weeks. Serum CEC was measured before and after the dietary intervention, by a well-established radioisotopic technique on Chinese Hamster Ovary Cells transfected with human ABCG1. The innovative synbiotic pasta consumption was associated to a significantly higher post treatment/baseline ratio of ABCG1-mediated CEC values with respect to control pasta (mean ratio 1.05 ± 0.037 and 0.95 ± 0.042 respectively, p < 0.05). Analysis of the relationship between ABCG1-mediated CEC and glycemia, homocysteine, total folates and interleukin-6 showed specific changes in the correlations between HDL function and glycemia, oxidative and inflammatory markers only after synbiotic pasta consumption.
CONCLUSION


This is the first report on serum CEC improvement obtained by a new synbiotic functional pasta consumption, in absence of lipid profile modifications, in overweight/obese participants. This pilot study suggests that a simple dietary intervention can be a promising approach to CV preservation through improving of athero-protective HDL function.",2020,"The innovative synbiotic pasta consumption was associated to a significantly higher post treatment/baseline ratio of ABCG1-mediated CEC values with respect to control pasta (mean ratio 1.05 ± 0.037 and 0.95 ± 0.042 respectively, p < 0.05).","['healthy overweight or obese individuals', 'Study participants (n\xa0=\xa041', 'healthy volunteers', 'overweight/obese participants']",['innovative or control pasta'],"['Serum CEC', 'Cholesterol efflux capacity (CEC', 'ABCG1-mediated CEC and glycemia, homocysteine, total folates and interleukin-6', 'HDL function and glycemia, oxidative and inflammatory markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}]","[{'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0450240', 'cui_str': 'Cassette'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",41.0,0.0354418,"The innovative synbiotic pasta consumption was associated to a significantly higher post treatment/baseline ratio of ABCG1-mediated CEC values with respect to control pasta (mean ratio 1.05 ± 0.037 and 0.95 ± 0.042 respectively, p < 0.05).","[{'ForeName': 'Elda', 'Initials': 'E', 'LastName': 'Favari', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Angelino', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cipollari', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Adorni', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zimetti', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Bernini', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ronda', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy. Electronic address: nicoletta.ronda@unipr.it.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Pellegrini', 'Affiliation': 'Department of Food and Drug, University of Parma, Parma, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.05.002']
1422,32605239,Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial.,"BACKGROUND


The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N).
METHODS


Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS.
RESULTS


Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant ( p  < 0.0001). The differences were statistically significant between the U and P groups (difference -48; 95% CI from -54 to -41) favoring the P group, and between the U and H groups (difference -45; 95% CI from -52 to -39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from -2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant ( p  < 0.0001) favoring the P and H groups.
CONCLUSIONS


The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.",2020,"The differences between treatments in clean mouth VAS was statistically significant ( p  < 0.0001) favoring the P and H groups.
","['Eligible participants were volunteer students', 'Dental Plaque Removal', 'Twenty-two participants']","['conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N', 'U-Shaped Automatic Electric Toothbrush']","['visual analogic scale (VAS) on subjective clean mouth sensation', 'clean mouth VAS', 'reduction in full-mouth plaque score (FMPS', 'FMPS reduction']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.133698,"The differences between treatments in clean mouth VAS was statistically significant ( p  < 0.0001) favoring the P and H groups.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, Orthodontics, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Giuntini', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Pagliaro', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Giani', 'Affiliation': 'Private Practice, Campi Bisenzio, 50013 Firenze, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Franchi', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Franceschi', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17134649']
1423,32610059,Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials.,"The objective of the reported research was to assess the impact of text message (SMS) reminders and their content on cervical screening rates. Women invited for cervical screening in Northwest London from February-October 2015 were eligible. 3133 women aged 24-29 (Study 1) were randomized (1, 1) to 'no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP). 11,405 women aged 30-64 (Study 2), were randomized (1, 1:1:1:1:1:1) to either: no SMS, an SMS without manipulation (SMS), the SMS-PCP, an SMS with a total or proportionate social norm (SMS-SNT or SMS-SNP), or an SMS with a gain-framed or loss-framed message (SMS-GF and SMS-LF). The primary outcome was participation at 18 weeks. In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002). In Study 2 participation was highest in the SMS-PCP (38.4%) and SMS (38.1%) arms compared to control (34.4%), (aOR: 1.19, 95%CI: 1.03-1.38; p = 0.02 and aOR: 1.18, 95%CI: 1.02-1.37; p = 0.03, respectively). The results demonstrate that behavioral SMSs improve cervical screening participation. The message content plays an important role in the impact of SMS. The results from this trial have already been used to designing effective policy for cervical cancer screening. The NHS Cervical Screening Programme started running a London-wide screening SMS campaign which was based on the cervical screening trial described here. According to figures published by Public Health England, after six months attendance increased by 4.8%, which is the equivalent of 13,400 more women being screened at 18 weeks.",2020,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","['3133 women aged 24-29 (Study 1', 'Women invited for cervical screening in Northwest London from February-October 2015 were eligible', '11,405 women aged 30-64 (Study 2']","['behavioral SMSs', ""no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP""]","['cervical screening participation', 'SMS-PCP', 'cervical screening rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]",11405.0,0.199584,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huf', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'King', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, UK.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Richmond', 'Affiliation': 'Breast Cancer Now, 5th Floor Ibex House, 42-47 Minories, London EC3N 1DY, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'West of London Breast Screening Service, Imperial College Healthcare NHS Trust, First Floor, Charing Cross Hospital, Fulham Palace Road, London W6 8RF, UK.'}, {'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Friedman', 'Affiliation': 'Faculty of Public Health, 4 St Andrews Place, London NW1 4LB, UK.'}, {'ForeName': 'Heema', 'Initials': 'H', 'LastName': 'Shukla', 'Affiliation': 'Global Health Capacity, Unit 4, Vista Place, Coy Pond Business Park Ingworth Road, Poole, BH12 1JY, UK.'}, {'ForeName': 'Fu-Min', 'Initials': 'FM', 'LastName': 'Tseng', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Judah', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Scarman Rd, Coventry CV4 7AL, UK. Electronic address: ivo.vlaev@wbs.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106170']
1424,32648100,Oral versus Injectable Antibiotics in Asymptomatic Neonates Born to Mothers with Risk Factors for Sepsis: A Pilot Randomized Controlled Trial.,"OBJECTIVE


To compare oral co-amoxiclav with injectable ampicillin and amikacin for the management of asymptomatic neonates born to mothers with risk factors for infection.
METHODS


This open label, randomized controlled trial was conducted in a tertiary care teaching hospital on neonates of gestational age ≥ 34 wk with maternal risk factors for infection, who were asymptomatic at birth and accepting breastfeeds. Newborns were randomized to receive either oral co-amoxiclav or injectable ampicillin and amikacin within 1-3 h after birth. Primary outcome variable was the development of clinical signs of sepsis with or without a positive blood culture by 72 h of life. Secondary outcome variables were development of sepsis with or without a positive blood culture by 7 d of life and adverse effects of drug therapy.
RESULTS


One hundred twenty-six newborns were randomized to receive either oral co-amoxyclav (n = 63) or injectable ampicillin and amikacin (n = 63). Data were analyzed on intention to treat basis. Both groups were comparable with respect to maternal and neonatal characteristics. Incidence of clinical sepsis within three days of age was similar between the groups [2 (3.2%) vs. 1 (1.6%) in injectable and oral groups, respectively; RR (95% CI) 0.500 (0.047-5.373); p = 0.567]. No significant difference was noted for the development of sepsis by 1 wk [1 (1.6%) vs. 0 in injectable and oral groups, respectively; RR (95% CI) 0.333 (0.014-8.03100); p = 0.499]. Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
CONCLUSIONS


Oral co-amoxyclav is as effective as injectable ampicillin and amikacin for management of asymptomatic neonates born to mothers with risk factors for infection.",2020,"Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
","['Newborns', 'asymptomatic neonates born to mothers with risk factors for infection', 'Asymptomatic Neonates Born to Mothers with Risk Factors for Sepsis', 'One hundred twenty-six newborns', 'tertiary care teaching hospital on neonates of gestational age\u2009≥']","['oral co-amoxiclav or injectable ampicillin and amikacin', 'oral co-amoxiclav with injectable ampicillin and amikacin', 'oral co-amoxyclav (n\u2009=\u200963) or injectable ampicillin and amikacin', 'ampicillin and amikacin', 'Oral versus Injectable Antibiotics']","['development of clinical signs of sepsis with or without a positive blood culture by 72\xa0h of life', 'development of sepsis', 'Adverse drug reactions such as vomiting, diarrhea and skin rash', 'development of sepsis with or without a positive blood culture by 7 d of life and adverse effects of drug therapy', 'Incidence of clinical sepsis']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3164780', 'cui_str': 'Clinical sepsis'}]",126.0,0.188147,"Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
","[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. ashokkumar_bhu@hotmail.com.'}, {'ForeName': 'Abhishek Kumar', 'Initials': 'AK', 'LastName': 'Dubey', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India.'}, {'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03412-x']
1425,32645890,The Effect of Different Cadence on Paddling Gross Efficiency and Economy in Stand-Up Paddle Boarding.,"Background:  Due to the importance of energy efficiency and economy in endurance performance, it is important to know the influence of different paddling cadences on these variables in the stand-up paddleboarding (SUP). The purpose of this study was to determine the effect of paddling at different cadences on the energy efficiency, economy, and physiological variables of international SUP race competitors.  Methods:  Ten male paddlers (age 28.8 ± 11.0 years; height 175.4 ± 5.1 m; body mass 74.2 ± 9.4 kg) participating in international tests carried out two test sessions. In the first one, an incremental exercise test was conducted to assess maximal oxygen uptake and peak power output (PPO). On the second day, they underwent 3 trials of 8 min each at 75% of PPO reached in the first test session. Three cadences were carried out in different trials randomly assigned between 45-55 and 65 strokes-min -1  (spm). Heart rate (HR), blood lactate, perceived sense of exertion (RPE), gross efficiency, economy, and oxygen uptake (VO 2 ) were measured in the middle (4-min) and the end (8-min) of each trial.  Results:  Economy (45.3 ± 5.7 KJ·l -1  at 45 spm vs. 38.1 ± 5.3 KJ·l -1  at 65 spm;  p  = 0.010) and gross efficiency (13.4 ± 2.3% at 45 spm vs. 11.0 ± 1.6% at 65 spm;  p  = 0.012) was higher during de 45 spm condition than 65 spm in the 8-min. Respiratory exchange ratio (RER) presented a lower value at 4-min than at 8-min in 55 spm (4-min, 0.950 ± 0.065 vs. 8-min, 0.964 ± 0.053) and 65 spm cadences (4-min, 0.951 ± 0.030 vs. 8-min, 0.992 ± 0.047;  p  < 0.05). VO 2 , HR, lactate, and RPE were lower ( p  < 0.05) at 45 spm (VO 2 , 34.4 ± 6.0 mL·kg -1 ·min -1 ; HR, 161.2 ± 16.4 beats·min -1 ; lactate, 3.5 ± 1.0 mmol·l -1 ; RPE, 6.0 ± 2.1) than at 55 spm (VO 2 , 38.6 ± 5.2 mL·kg -1 ·min -1 ; HR, 168.1 ± 15.1 beats·min -1 ; lactate, 4.2 ± 1.2 mmol·l -1 ; RPE, 6.9 ± 1.4) and 65 spm (VO 2 , 38.7 ± 5.9 mL·kg -1 ·min -1 ; HR, 170.7 ± 13.0 beats·min -1 ; 5.3 ± 1.8 mmol·l -1 ; RPE, 7.6 ± 1.4) at 8-min. Moreover, lactate and RPE at 65 spm was greater than 55 spm ( p  < 0.05) at 8-min.  Conclusion:  International male SUP paddlers were most efficient and economical when paddling at 45 spm vs. 55 or 65 spm, confirmed by lower RPE values, which may likely translate to faster paddling speed and greater endurance.",2020,"VO 2 , HR, lactate, and RPE were lower ( p  < 0.05) at 45 spm (VO 2 , 34.4 ± 6.0 mL·kg -1 ·min -1 ; HR, 161.2 ± 16.4 beats·min -1 ; lactate, 3.5 ± 1.0 mmol·l -1 ; RPE, 6.0 ± 2.1) than at 55 spm (VO 2 , 38.6 ± 5.2 mL·kg -1 ·min -1 ; HR, 168.1 ± 15.1 beats·min -1 ; lactate, 4.2 ± 1.2 mmol·l -1 ; RPE, 6.9 ± 1.4) and 65 spm (VO 2 , 38.7 ± 5.9 mL·kg -1 ·min -1 ; HR, 170.7 ± 13.0 beats·min -1 ; 5.3 ± 1.8 mmol·l -1 ; RPE, 7.6 ± 1.4) at 8-min.",['Methods:  Ten male paddlers (age 28.8 ± 11.0 years; height 175.4 ± 5.1 m; body mass 74.2 ± 9.4 kg) participating in international tests carried out two test sessions'],[],"['Respiratory exchange ratio (RER', 'lactate and RPE', 'maximal oxygen uptake and peak power output (PPO', 'Heart rate (HR), blood lactate, perceived sense of exertion (RPE), gross efficiency, economy, and oxygen uptake (VO 2 ', 'gross efficiency', 'VO 2 , HR, lactate, and RPE']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]",[],"[{'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0032956', 'cui_str': 'Preferred Provider Organization'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",2.0,0.0798461,"VO 2 , HR, lactate, and RPE were lower ( p  < 0.05) at 45 spm (VO 2 , 34.4 ± 6.0 mL·kg -1 ·min -1 ; HR, 161.2 ± 16.4 beats·min -1 ; lactate, 3.5 ± 1.0 mmol·l -1 ; RPE, 6.0 ± 2.1) than at 55 spm (VO 2 , 38.6 ± 5.2 mL·kg -1 ·min -1 ; HR, 168.1 ± 15.1 beats·min -1 ; lactate, 4.2 ± 1.2 mmol·l -1 ; RPE, 6.9 ± 1.4) and 65 spm (VO 2 , 38.7 ± 5.9 mL·kg -1 ·min -1 ; HR, 170.7 ± 13.0 beats·min -1 ; 5.3 ± 1.8 mmol·l -1 ; RPE, 7.6 ± 1.4) at 8-min.","[{'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Castañeda-Babarro', 'Affiliation': 'Health, Physical Activity and Sports Science Laboratory, Department of Physical Activity and Sports, Faculty of Psychology and Education, University of Deusto, 48007 Bizkaia, Spain.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Santos-Concejero', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport, University of the Basque Country UPV/EHU, 01007 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Viribay', 'Affiliation': 'Glut4Science, Physiology, Nutrition and Sport, 01004 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Gutiérrez-Santamaría', 'Affiliation': 'Health, Physical Activity and Sports Science Laboratory, Department of Physical Activity and Sports, Faculty of Psychology and Education, University of Deusto, 48007 Bizkaia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, University of Valladolid, 42004 Soria, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134893']
1426,32645892,Analysis of Motor Intervention Program on the Development of Gross Motor Skills in Preschoolers.,"This study aimed to investigate the influence of a structured movement activity program on the motor development of children aged three to five years attending preschool. Participants were 136 preschool students with normative development at three to four years old who lived in the Region of Murcia (Spain). The McCarthy Children's Psychomotricity and Aptitude Scales (MSCA) battery of psychomotor tests was used to evaluate the motor development profiles of preschoolers before and after the intervention. The sample was divided into two groups: an intervention group (28 students) and a comparison group (108 students). A structured 24 week physical education program was used in the intervention group. An experiential program based on free play was used in the comparison group during the same period. Preschoolers in both groups got a significant improvement in the contrast of pre-intervention with post-intervention in limb coordination. Statistically significant differences in the post-intervention measurements between the comparison group and the intervention group on arm and leg coordination were observed, whereby the intervention group presented higher arm coordination values ( F 1,134  = 14,389,  p  = 0.000,  η 2  = 0.097) and higher leg coordination values ( F 1,134  = 19,281,  p  = 0.000,  η 2  = 0.126) than the comparison group. It was pointed out that structured physical activity education is better educational methodology than free play to achieve adequate motor development in preschool children.",2020,Preschoolers in both groups got a significant improvement in the contrast of pre-intervention with post-intervention in limb coordination.,"['Participants were 136 preschool students with normative development at three to four years old who lived in the Region of Murcia (Spain', 'children aged three to five years attending preschool', 'Preschoolers', 'preschool children']","['structured movement activity program', 'Motor Intervention Program']","[""McCarthy Children's Psychomotricity and Aptitude Scales (MSCA) battery of psychomotor tests"", 'higher arm coordination values', 'higher leg coordination values', 'leg coordination']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003646', 'cui_str': 'Aptitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",136.0,0.015633,Preschoolers in both groups got a significant improvement in the contrast of pre-intervention with post-intervention in limb coordination.,"[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ruiz-Esteban', 'Affiliation': 'Department of Evolutionary and Educational Psychology, Campus Regional Excellence Mare Nostrum, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Terry Andrés', 'Affiliation': 'Department of Evolutionary and Educational Psychology, Campus Regional Excellence Mare Nostrum, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Méndez', 'Affiliation': 'Department of Evolutionary and Educational Psychology, Campus Regional Excellence Mare Nostrum, University of Murcia, 30100 Murcia, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Morales', 'Affiliation': 'Department of Music, Autonomous University of Madrid, 28049 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134891']
1427,32604381,Omitting Routine Radiography of Traumatic Ankle Fractures After Initial 2-Week Follow-up Does Not Affect Outcomes: The WARRIOR Trial: A Multicenter Randomized Controlled Trial.,"BACKGROUND


The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to determine if routine radiographs made at weeks 6 and 12 can be omitted without compromising clinical outcomes.
METHODS


This multicenter randomized controlled trial with a noninferiority design included 246 patients with an ankle fracture, 153 (62%) of whom received operative treatment. At 6 and 12 weeks of follow-up, patients in the routine-care group (n = 128) received routine radiographs whereas patients in the reduced-imaging group (n = 118) did not. The primary outcome was the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were the American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made. The outcomes were assessed at baseline and at 6, 12, 26, and 52 weeks of follow-up. Data were analyzed with use of mixed models.
RESULTS


Reduced imaging was noninferior compared with routine care in terms of OMAS scores (difference [β], -0.9; 95% confidence interval [CI], -6.2 to 4.4). AAOS scores, HRQoL, pain, health perception, and self-perceived recovery did not differ between groups. Patients in the reduced-imaging group received a median of 4 radiographs, whereas those in the routine-care group received a median of 5 radiographs (p < 0.05). The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42). The types of complications were also similar.
CONCLUSIONS


Implementation of a reduced-imaging protocol following an ankle fracture has no measurable negative effects on functional outcome, pain, and complication rates during the first year of follow-up. The number of follow-up radiographs can be reduced by implementing this protocol.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42).","['patients with ankle fracture', '246 patients with an ankle fracture, 153 (62%) of whom received operative treatment', 'Traumatic Ankle Fractures']",['routine radiographs'],"['American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made', 'AAOS scores, HRQoL, pain, health perception, and self-perceived recovery', 'Olerud-Molander Ankle Score (OMAS', 'OMAS scores', 'functional outcome, pain, and complication rates', 'rates of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",246.0,0.207996,"The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'van Gerven', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Zuidema', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El Moumni', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Amsterdam Movement Science Research Institute, Department of Health Sciences, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Amsterdam Movement Science Research Institute, Department of Health Sciences, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Schipper', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Termaat', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01381']
1428,32609576,"Evaluation of Patient's Perceptions, Healing, and Reattachment After Conventional and Diode Laser Frenectomy: A Three-Arm Randomized Clinical Trial.","Objective:  The aim of this study is to compare the conventional and diode laser techniques in terms of patient's perceptions, epithelization, reattachment, and periodontal clinical parameters in the treatment of abnormal papillary frenum.  Materials and methods:  Forty-eight patients with abnormal papillary frenum were enrolled in the study. Patients were randomly assigned into three groups; conventional frenectomy operation (C group), diode laser-assisted frenectomy (L group), and diode laser-assisted frenectomy with conventional horizontal incision on the periosteum (L + P group). Postoperative pain, discomfort in speaking, and chewing scores were assessed with visual analogue scale (VAS) at postoperative 3rd hour and on days 1, 7, 14, 21, and 45. Epithelialization process of the wound surface was evaluated by hydrogen peroxide solution applied to the wound on days 7, 14, 21, and 45 following operations. The distance between the frenum attachment point and mucogingival junction (FMGJ) was recorded at baseline, postoperative 45th day, and 6th month to assess the reattachment of the frenum. Plaque index, gingival index, bleeding on probing, and probing depth were recorded at baseline and postoperative 7th, 14th, 21 st , and 45th days.  Results:  On the 1st and 7th day after operation, VAS pain score in the C group was significantly higher than in the L and L + P groups ( p  < 0.017). Difficulty in speaking and chewing scores were significantly lower in the L and L + P groups compared to the C group at postoperative 3rd hour and 7th day ( p  < 0.017). The FMGJ and epithelization period demonstrated no difference among the groups at any time point ( p  > 0.05).  Conclusions:  Our results suggest that diode laser provides better postoperative patient's perceptions than the conventional technique in frenectomy operation. In addition, both conventional and laser-assisted frenectomy surgeries prevent the frenum reattachment regardless of periosteal horizontal incision.",2020,Difficulty in speaking and chewing scores were significantly lower in the L and L + P groups compared to the C group at post-operative 3rd hour and 7th day ( p  < 0.017).,"['Forty-eight patients with abnormal papillary frenum were enrolled in the study', 'abnormal papillary frenum']","['conventional frenectomy operation (C group), diode laser-assisted frenectomy (L group), and diode laser-assisted frenectomy with conventional horizontal incision on the periosteum (L\u2009+\u2009P group', 'conventional and laser-assisted frenectomy surgeries', 'Conventional and Diode Laser Frenectomy', 'diode laser', 'conventional and diode laser techniques', 'hydrogen peroxide solution']","['VAS pain score', 'visual analogue scale (VAS', 'Plaque index, gingival index, bleeding on probing, and probing depth', 'mucogingival junction (FMGJ', 'Post-operative pain, discomfort in speaking, and chewing scores', 'Difficulty in speaking and chewing scores', ""Patient's Perceptions, Healing, and Reattachment""]","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0031110', 'cui_str': 'Periosteum'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0447454', 'cui_str': 'Mucogingival junction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}]",48.0,0.0357075,Difficulty in speaking and chewing scores were significantly lower in the L and L + P groups compared to the C group at post-operative 3rd hour and 7th day ( p  < 0.017).,"[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Sezgin', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Hafize', 'Initials': 'H', 'LastName': 'Öztürk Özener', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Suleyman Emre', 'Initials': 'SE', 'LastName': 'Meseli', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Istanbul Aydin University, Istanbul, Turkey.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Kuru', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4783']
1429,32610487,A Three-Arm Randomised Controlled Trial of High- and Low-Intensity Implementation Strategies to Support Centre-Based Childcare Service Implementation of Nutrition Guidelines: 12-Month Follow-Up.,"The study aimed to compare the effectiveness of a suite of implementation strategies of varying intensities on centre-based childcare service implementation of nutrition guideline recommendations at 12-month follow-up. A six-month three-arm parallel group randomised controlled trial was undertaken with 69 services, randomised to one of three arms: high-intensity strategies (executive support; group face-to-face training; provision of resources; multiple rounds of audit and feedback; ongoing face-to-face and phone support); low-intensity strategies (group face-to-face training; provision of resources; single round of audit and feedback); or usual care control. Across all study arms, only three high-intensity services were compliant with overall nutrition guidelines. A significant group interaction was found between the three arms for compliance with individual food groups. Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods. No significant differences between the high- and low-intensity for individual food group compliance were found. High-intensity implementation strategies may be effective in supporting childcare service implementation of individual food group recommendations. Further research is warranted to identify strategies effective in increasing overall nutrition compliance.",2020,"Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods.",['to Support Centre-Based Childcare Service Implementation of Nutrition Guidelines'],"['high-intensity strategies (executive support; group face-to-face training; provision of resources; multiple rounds of audit and feedback; ongoing face-to-face and phone support); low-intensity strategies (group face-to-face training; provision of resources; single round of audit and feedback); or usual care control', 'High- and Low-Intensity Implementation Strategies']",[],"[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],,0.0519355,"Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Seward', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Local Health District, Population Health, Wallsend 2287, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17134664']
1430,32610640,Be a Mom 's Efficacy in Enhancing Positive Mental Health among Postpartum Women Presenting Low Risk for Postpartum Depression: Results from a Pilot Randomized Trial.,"In this study, we conducted a preliminary investigation of the efficacy of  Be a Mom , a web-based self-guided intervention, in enhancing positive mental health among postpartum women at low risk for postpartum depression. Additionally, we examined  Be a Mom 's efficacy regarding secondary outcomes as well as its acceptability and adherence. A total of 367 participants were randomly assigned to the  Be a Mom  group ( n  = 191) or to the waiting-list control group ( n  = 176) and completed baseline (T1) and postintervention (T2) assessments. The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group. Additionally, group effects were found for depressive and anxiety symptoms. A significantly higher proportion of participants in the  Be a Mom  group had an improvement trajectory (from not flourishing at T1 to flourishing at T2). A total of 62 (32.5%) women completed  Be a Mom , and most would use it again if needed ( n  = 82/113; 72.6%). This study provides preliminary evidence of  Be a Mom 's efficacy in increasing positive mental health among low-risk postpartum women. Our findings support mental health promotion strategies in the postpartum period and highlight the important role of web-based CBT interventions.",2020,The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group.,"['Postpartum Women Presenting Low Risk for Postpartum Depression', 'postpartum women at low risk for postpartum depression', 'low-risk postpartum women', 'A total of 367 participants', 'A total of 62 (32.5%) women completed  Be a Mom']",['waiting-list control group'],"['depressive and anxiety symptoms', 'acceptability and adherence', 'positive mental health']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C1442163', 'cui_str': 'MoM'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",367.0,0.0973773,The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group.,"[{'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Monteiro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Canavarro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17134679']
1431,32610864,"A Prospective, Randomized, Interventional Study of Oral Iron Supplementation Comparing Daily Dose with Alternate Day Regimen Using Hepcidin as a Biomarker in Iron Deficiency Anemia.","Aim


To assess effect of daily vis-a-vis alternate day oral iron therapy in terms of hemoglobin, reticulocyte hemoglobin equivalent (RET-He) and GI side effects using hepcidin as a biomarker.
Methods


A hospital based randomized interventional two-arm analytical study was done among patients of IDA (20 in each group). The study population was divided into two groups by randomisation. Group 1 received oral iron supplements on alternate day and Group 2 received iron supplements daily. Hemoglobin, RET-He, Serum ferritin and Hepcidin level were assessed.
Results


On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group. On day 3, the rise in hepcidin was significant from base line in both the groups but the mean change in hepcidin was more in daily therapy group. RET-He began increasing on day 2nd in both the groups. In alternate day therapy group, the rise in RET-He was significant from base line from the day 2nd onwards while the rise in RET-He in daily therapy group was not significant even on day 3. In alternate day iron therapy group, the mean increase in hemoglobin on day 21th (1.58 ±0.53 gm/dl) was significantly more than mean increase among daily therapy (0.41 ± 0.25 gm/dl, P <0.05).
Conclusion


Alternate day single tablet dosing schedule of oral iron therapy (60mg of elemental iron, ferrous sulfate) was more effective and better tolerated (gastrointestinal side effects) compared to daily supplementation in IDA.",2020,"On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group.",['patients of IDA (20 in each group'],"['daily vis-a-vis alternate day oral iron therapy', 'Oral Iron Supplementation', 'oral iron therapy (60mg of elemental iron, ferrous sulfate', 'oral iron supplements']","['Hemoglobin, RET-He, Serum ferritin and Hepcidin level', 'mean increase in hemoglobin', 'effective and better tolerated (gastrointestinal side effects', 'hemoglobin, reticulocyte hemoglobin equivalent (RET-He) and GI side effects', 'rise in Hepcidin', 'rise in RET-He', 'rise in hepcidin', 'mean change in hepcidin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1571809', 'cui_str': 'Visceral manipulation'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4049225', 'cui_str': 'Reticulocyte haemoglobin equivalent'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0337129,"On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group.","[{'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Senior Professor, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Bhawani Shankar', 'Initials': 'BS', 'LastName': 'Sharma', 'Affiliation': 'Resident, Department of Medicine, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Senior Professor, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Assistant Professor, Department of Pathology, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Laxmi Kant', 'Initials': 'LK', 'LastName': 'Goyal', 'Affiliation': 'Assistant Professor, Geriatric Medicine, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Shaurya', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Senior Resident, Department of Medicine, SMS Medical College, Jaipur, Rajasthan.'}]",The Journal of the Association of Physicians of India,[]
1432,32616489,"Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial).","INTRODUCTION


Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples, a male factor is involved. Most of the male infertile cases are characterised as 'idiopathic', except for a small percentage of cases which are causative by a genetic aetiology. In the past decade, the role of oxidative stress related to sperm quality has been researched thoroughly and estimated to be the problem in 25%-87% of male infertility cases. Impryl is a nutritional supplement which works on the metabolic system and the regulation of oxidative stress by activating the 1-carbon cycle and therefore recycling of homocysteine. We hypothesise that the nutritional supplement Impryl in men of infertile couples might improve the ongoing pregnancy rate.
METHODS AND ANALYSIS


We designed a multicentre, randomised, double-blind, placebo-controlled clinical trial. We aimed to include 1200 male adults aged 18-50 years, part of a couple that is diagnosed with infertility. The couple will either start or has already been started with fertility treatment, that is, expectative management (duration of 6 months), intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment. Male participants will be randomised in either the Impryl or the placebo group, with identical appearance of the tablets to be distributed (doses: one tablet each day), for a total duration of maximal 6 months. Patients can start directly with fertility treatment and/or natural conception. The primary outcome is the number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window between randomisation up to and including month 6 of intervention use. Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count. Furthermore the number of pregnancies conceived in the optimal intervention time window (after full spermatogenesis of 72 days), overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events are documented within the study period of 15 months.
ETHICS AND DISSEMINATION


The protocol is approved by the local medical ethical review committee at the Radboud University Medical Centre and by the national Central Committee on Research Involving Human Subjects. Findings will be shared with the academic and medical community, funding and patient organisations in order to contribute to optimisation of medical care and quality of life for patients with infertility.
TRIAL REGISTRATION NUMBERS


NCT03337360 and NTR6551.",2020,"Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count.","['men of infertile couples', 'male infertile cases', 'patients with infertility', 'Male participants', 'male fertility', '1200 male adults aged 18-50 years, part of a couple that is diagnosed with infertility']","['intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment', 'nutritional supplement (Impryl', 'placebo']","['change in semen parameters', 'overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events', 'number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window', 'IUI/IVF/ICSI group, based on (prewash) total motile sperm count']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0429916', 'cui_str': 'Number of miscarriages'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033010', 'cui_str': 'Pregnancy confirmed'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",1200.0,0.404305,"Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count.","[{'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'Smits', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands roos.smits@radboudumc.nl.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': ""D'Hauwers"", 'Affiliation': 'Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Didi', 'Initials': 'D', 'LastName': 'Braat', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Fleischer', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035069']
1433,32684359,Improving Colorectal Cancer Screening in a Rural Setting: A Randomized Study.,"INTRODUCTION


Colorectal cancer screening has been shown to prevent or detect early colorectal cancer and reduce mortality; yet, adherence to screening recommendations remains low, particularly in rural settings.
STUDY DESIGN


RCT.
SETTING/PARTICIPANTS


Adults (n=7,812) aged 50-75 years and due for colorectal cancer screening in a largely rural health system were randomly assigned to either the intervention (n=3,906) or the control (n=3,906) group in September 2016, with analysis following through 2018.
INTERVENTION


A mailed motivational messaging screening reminder letter with an option to call and request a free at-home fecal immunochemical screening test (intervention) or the standard invitation letter detailing that the individual was due for screening (control). Multifaceted motivational messaging emphasized colorectal cancer preventability and the ease and affordability of screening, and communicated a limited supply of test kits.
MAIN OUTCOME MEASURES


Colorectal cancer screening participation within 6 months after mailed invitation was ascertained from the electronic medical record.
RESULTS


Colorectal cancer screening participation was significantly improved in the intervention (30.1%) vs the usual care control group (22.5%; p<0.001). Individuals randomized to the intervention group had 49% higher odds of being screened over follow-up than those randomized to the control group (OR=1.49, 95% CI=1.34, 1.65). A total of 13.2 screening invitations were needed to accomplish 1 additional screening over the usual care. Of the 233 fecal immunochemical test kits mailed to participants, 154 (66.1%) were returned, and 18 (11.7%) tested positive.
CONCLUSIONS


A mailed motivational messaging letter with a low-cost screening alternative increased colorectal cancer screening in this largely rural community with generally poor adherence to screening recommendations. Mailed colorectal cancer screening reminders using motivational messaging may be an effective method for increasing screening and reducing rural colorectal cancer disparities.",2020,"RESULTS


Colorectal cancer screening participation was significantly improved in the intervention (30.1%) vs the usual care control group (22.5%; p<0.001).","['Adults (n=7,812', 'aged 50-75 years and due for colorectal cancer screening in a largely rural health system']",['motivational messaging screening reminder letter with an option to call and request a free at-home fecal immunochemical screening test (intervention) or the standard invitation letter detailing that the individual was due for screening (control'],['Colorectal cancer screening participation'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",7812.0,0.0487801,"RESULTS


Colorectal cancer screening participation was significantly improved in the intervention (30.1%) vs the usual care control group (22.5%; p<0.001).","[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hirko', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, Michigan. Electronic address: khirko@epi.msu.edu.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Lennon', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, Michigan; Division of Public Health, College of Human Medicine, Michigan State University, Flint, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Miller', 'Affiliation': 'Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Jimbo', 'Affiliation': 'Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan; Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Leibfritz', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}, {'ForeName': 'Suzanne J', 'Initials': 'SJ', 'LastName': 'Knoff', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Janney', 'Affiliation': 'Department of Psychiatry, College of Human Medicine West Michigan, Michigan State University, Grand Rapids, Michigan; Pine Rest Christian Mental Health Services, Grand Rapids, Michigan.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Berg', 'Affiliation': 'MidMichigan Health, Midland, Michigan.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.019']
1434,32619868,Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults.,"Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial (""X:BOT"") comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.",2020,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","['black adults', '73 Black participants with OUD (81% male, mean age 39.05, SD\xa0=\xa011.80) participating']","['extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX', 'naltrexone', 'buprenorphine-naloxone']",['relapse rates'],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",73.0,0.101327,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Haeny', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 34 Park St., New Haven, CT 06511, United States. Electronic address: angela.haeny@yale.edu.'}, {'ForeName': 'LaTrice', 'Initials': 'L', 'LastName': 'Montgomery', 'Affiliation': 'University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience, 3131 Harvey Avenue., Cincinnati, OH 45229, United States.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, Department of Psychology, 2600 Clifton Ave., Cincinnati, OH 45221, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, One Park Ave., New York, NY 10016, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106514']
1435,32622294,The effects of yoga on functionality appreciation and additional facets of positive body image.,"This study investigated the effects of yoga on functionality appreciation, and the potential mechanisms that could explain the impact of yoga on additional facets of positive body image. Young adult women (N = 114; M age  = 22.19) were randomised to a 10-week Hatha yoga programme or waitlist control group. Participants completed measures of functionality appreciation, body appreciation, body compassion, appearance evaluation, self-objectification, and embodiment at Pretest, Midtest, Posttest, and 1-month Follow-Up. Follow-up data could not be analysed due to high levels of attrition. The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time. Further, all participants experienced improvements in body appreciation, body compassion, and appearance evaluation over time, regardless of their assigned group. Lower self-objectification contributed to improvements in body appreciation and body compassion. In addition, greater embodiment contributed to improvements in body appreciation, body compassion, and appearance evaluation. Contrary to our expectations, yoga did not lead to increased functionality appreciation, nor was functionality appreciation a mediator of the impact of yoga on positive body image. Instead, lower self-objectification, and greater embodiment, drove improvements in positive body image.",2020,"The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time.",['Young adult women (N\u202f=\u202f114; M age \u202f=\u202f22.19'],['Hatha yoga programme or waitlist control group'],"['body appreciation and body compassion', 'functionality appreciation, body appreciation, body compassion, appearance evaluation, self-objectification, and embodiment at Pretest, Midtest, Posttest, and 1-month Follow-Up', 'body appreciation, body compassion, and appearance evaluation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0268438,"The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Alleva', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands. Electronic address: Jessica.Alleva@maastrichtuniversity.nl.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Tylka', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Oorsouw', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Montanaro', 'Affiliation': 'Department of Psychology, The University of North Carolina at Charlotte, Charlotte, NC, United States.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Perey', 'Affiliation': 'Chair of Sport and Health Management, Technical University of Munich, Germany.'}, {'ForeName': 'Cheyenne', 'Initials': 'C', 'LastName': 'Bolle', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jantine', 'Initials': 'J', 'LastName': 'Boselie', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, The University of North Carolina at Charlotte, Charlotte, NC, United States.'}]",Body image,['10.1016/j.bodyim.2020.06.003']
1436,32622585,"Corrigendum to ""A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors"" [Clin. Neurophysiol. 131 (2020) 1533-1547].",,2020,,"['pediatric brain tumor survivors"" [Clin', '131']",['exercise training'],['cognition and neural communication'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0160611,,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: arasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.06.002']
1437,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1438,32624468,Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors.,"INTRODUCTION


The eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.
METHODS AND ANALYSIS


This is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app ('Be-with-You'), while the control group will use a general health app ('Sham' app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.
ETHICS AND DISSEMINATION


The Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.
TRIAL REGISTRATION NUMBER


ChiCTR1900026244.",2020,"The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills.","['breast cancer survivors', 'Eligible participants']","[""self-management app ('Be-with-You'), while the control group will use a general health app ('Sham' app"", 'self-management application (app']","['self-efficacy, readiness for change and health-related quality of life', 'health literacy, problem-solving skills and self-management skills']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",,0.111542,"The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills.","[{'ForeName': 'Andy S K', 'Initials': 'ASK', 'LastName': 'Cheng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong andy.cheng@polyu.edu.hk.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Peter H F', 'Initials': 'PHF', 'LastName': 'Ng', 'Affiliation': 'Department of Computing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Cindy T T', 'Initials': 'CTT', 'LastName': 'Kwok', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Feuerstein', 'Affiliation': 'Consultant in Cancer Survivorship, Gaithersburg, Maryland, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034655']
1439,32632657,Correction to: Prebiotic effect of inulin‑type fructans on faecal microbiota and short‑chain fatty acids in type 2 diabetes: a randomised controlled trial.,The original version of this article unfortunately contained a mistake. The presentation of Fig. 4 was incorrect.,2020,The original version of this article unfortunately contained a mistake.,['type 2 diabetes'],['inulin‑type fructans'],['faecal microbiota and short‑chain fatty acids'],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0016743', 'cui_str': 'Levans'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]",,0.0311723,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway. eline.birkeland@ous-hf.no.'}, {'ForeName': 'Sedegheh', 'Initials': 'S', 'LastName': 'Gharagozlian', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Måge', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02314-0']
1440,32628547,Correction to: Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Ticagrelor-Induced Platelet Inhibition in Acute Myocardial Infarction: The Randomized MonAMI Trial.,,2020,,['Acute Myocardial Infarction'],"['Morphine', 'Metoclopramide Coadministration']",[],"[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]",[],,0.053671,,[],Circulation,['10.1161/CIR.0000000000000881']
1441,32630164,The Application of Intra-Articulr Injections for Management of the Consequences of Disc Displacement without Reduction.,"The aim of the study was to make a comparative studies on the effectiveness of platelet rich plasma (PRP) and hyaluronic acid (HA) in intra-articular injections to the temporomandibular joints-in double blind studies application-based on the analysis of selected clinical parameters of functional efficiency and the mean value of joint's pain intensity before and after management. The study enrolled a group of 100 patients, aged 21 to 43 years, of both sexes, who came for the prosthodontic treatment. All patients had II b group of disorder according to the Research Diagnostic Criteria/Temporomandibular Disorder, and were consecutively, alternately assigned to the groups, 50 patients in each. Study group PRP was treated with intra-articular injection of platelet rich plasma and study group HA had injection with hyaluronic acid. The examination was double-blind, so that the injecting physician and the patient were not informed what kind of medicinal substance they received in the joint injection. The final selected clinical parameters did not differ statistically significantly between the groups, what means that both administered substances were effective in the repair of intra-articular structures. The results of research showed that the use of PRP and HA in intraarticular joint's injections positively affects in selected clinical parameters and decrease of the pain in temporomandibular joints in the case of disc displacement without reduction.",2020,"The final selected clinical parameters did not differ statistically significantly between the groups, what means that both administered substances were effective in the repair of intra-articular structures.","['All patients had II b group of disorder according to the Research Diagnostic Criteria/Temporomandibular Disorder', '100 patients, aged 21 to 43 years, of both sexes, who came for the prosthodontic treatment']","['platelet rich plasma (PRP) and hyaluronic acid (HA', 'hyaluronic acid']","['pain in temporomandibular joints', 'repair of intra-articular structures']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}]","[{'cui': 'C0155943', 'cui_str': 'Arthralgia of temporomandibular joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]",100.0,0.0469652,"The final selected clinical parameters did not differ statistically significantly between the groups, what means that both administered substances were effective in the repair of intra-articular structures.","[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Pihut', 'Affiliation': 'Prosthodontics Department, Consulting Room of Temporomandibular Disorders, Jagiellonian University, Medical College, 4 Montelupich Str., 31-155 Krakow, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Gala', 'Affiliation': 'Prosthodontics Department, Consulting Room of Temporomandibular Disorders, Jagiellonian University, Medical College, 4 Montelupich Str., 31-155 Krakow, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17134726']
1442,32630188,Comparison of Aquatic Therapy vs. Dry Land Therapy to Improve Mobility of Chronic Stroke Patients.,"One of the most serious and disabling problems of stroke is pain and a decrease in balance, with the consequent increased risk of falls. The aim of the randomized controlled trial study was to compare the efficacy of three different treatment proposals to improve pain, gait, and balance in chronic stroke patients. Forty patients diagnosed with stroke were divided into three groups: the dry-land therapy group (control group) received sessions that included walking exercises and trunk mobility. The experimental group received Ai Chi aquatic therapy, and the combined group received alternating dry-land therapy sessions and Ai Chi aquatic therapy. The measurement instruments used were: the Tinetti balance and gait scale, the visual analog scale (VAS), 360° turn, single leg stance, and the 30-s stand test (CS-30). After twelve weeks of treatment, the results were significantly better for the combined therapy group and the experimental group compared to the dry-land therapy group ( p  < 0.01) in the VAS scale, CS-30, and 360° turn, although improvements were also found in the evaluations carried out in the aquatic therapy group. In total, for the Tinetti scale and single-leg stance, the differences between the groups were evident, although not statistically significant ( p  = 0.001). Aquatic therapy with Ai Chi and the combination of aquatic therapy with dry-land therapy was effective in improving pain, balance, and gait in patients with chronic stroke, thus improving their functional capacity and quality of life.",2020,"After twelve weeks of treatment, the results were significantly better for the combined therapy group and the experimental group compared to the dry-land therapy group ( p  < 0.01) in the VAS scale, CS-30, and 360° turn, although improvements were also found in the evaluations carried out in the aquatic therapy group.","['Chronic Stroke Patients', 'patients with chronic stroke', 'Forty patients diagnosed with stroke', 'chronic stroke patients']","['Aquatic Therapy vs. Dry Land Therapy', 'dry-land therapy group (control group) received sessions that included walking exercises and trunk mobility', 'Aquatic therapy with Ai Chi and the combination of aquatic therapy with dry-land therapy', 'Ai Chi aquatic therapy, and the combined group received alternating dry-land therapy sessions and Ai Chi aquatic therapy']","['pain, balance, and gait', 'Tinetti balance and gait scale, the visual analog scale (VAS), 360° turn, single leg stance, and the 30-s stand test (CS-30', 'Tinetti scale and single-leg stance', 'functional capacity and quality of life', 'pain, gait, and balance']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2732846', 'cui_str': 'Tinetti balance and gait scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0139959,"After twelve weeks of treatment, the results were significantly better for the combined therapy group and the experimental group compared to the dry-land therapy group ( p  < 0.01) in the VAS scale, CS-30, and 360° turn, although improvements were also found in the evaluations carried out in the aquatic therapy group.","[{'ForeName': 'Sagrario', 'Initials': 'S', 'LastName': 'Pérez-de la Cruz', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, 04120 Almería, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134728']
1443,32630214,Effects of Exercise Training during Christmas on Body Weight and Cardiometabolic Health in Overweight Individuals.,":  Individuals with abdominal obesity and metabolic syndrome (MetS) have augmented risk of all-cause mortality. Lifestyle interventions are effective to treat MetS, however, there are periods during the year in which exercise programs are discontinued and improper dietary habits reappear (e.g., Christmas holidays). We aimed to analyze if exercise-training during Christmas holidays would avoid body-weight gains and cardiometabolic deterioration in MetS individuals, using a randomized control trial. Thirty-eight men with MetS undergoing exercise training were randomly allocated to either continue (TRAIN group, n = 16) or discontinue (HOLID group, n = 22) training, during the three weeks of Christmas. Anthropometrics (body weight, fat, and waist circumference), fasting blood metabolites (glucose, insulin, triglycerides, and cholesterol concentrations) and exercise maximal fat oxidation (FO MAX ) and oxygen uptake (VO 2PEAK ) were determined before and after Christmas. Both groups were similar at baseline in all parameters ( p  > 0.05). HOLID group increased body weight (91.3 ± 13.0 to 92.0 ± 13.4 kg,  p  = 0.004), mean arterial pressure (94.0 ± 10.6 to 97.1 ± 8.9 mmHg,  p  = 0.026), blood insulin (10.2 ± 3.8 to 12.5 ± 5.4 µIU·mL -1 ,  p  = 0.003) and HOMA (3.2 ± 1.3 to 4.1 ± 2.3,  p  = 0.003). In contrast, TRAIN prevented those disarrangements and reduced total (170.6 ± 30.6 to 161.3 ± 31.3 mg·dL -1 ,  p  = 0.026) and low-density lipoprotein cholesterol (i.e., LDL- C , 104.8 ± 26.1 to 95.6 ± 21.7 mg·dL -1 ,  p  = 0.013). TRAIN also prevented the reductions in exercise FO MAX  and VO 2PEAK  that was observed in the HOLID group ( p  = 0.002). In conclusion, exercise training during Christmas, prevents body weight gains and the associated cardiovascular (increase in blood pressure and LDL -C ) and metabolic (reduced insulin sensitivity) health risks are an optimal non-pharmacological therapy for that period of the year.",2020,Both groups were similar at baseline in all parameters ( p  > 0.05).,"['  Individuals with abdominal obesity and metabolic syndrome (MetS', 'Overweight Individuals', 'Thirty-eight men with MetS undergoing exercise training']","['exercise training', 'Exercise Training', 'discontinue (HOLID group, n = 22) training', 'exercise-training']","['body weight gains', 'blood insulin', 'body weight', 'low-density lipoprotein cholesterol', 'Body Weight and Cardiometabolic Health', 'blood pressure and LDL -C ) and metabolic (reduced insulin sensitivity) health risks', 'exercise FO MAX  and VO 2PEAK', 'mean arterial pressure', 'Anthropometrics (body weight, fat, and waist circumference), fasting blood metabolites (glucose, insulin, triglycerides, and cholesterol concentrations) and exercise maximal fat oxidation (FO MAX ) and oxygen uptake (VO 2PEAK ']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",38.0,0.0169114,Both groups were similar at baseline in all parameters ( p  > 0.05).,"[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Valle', 'Initials': 'V', 'LastName': 'Guio de Prada', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134732']
1444,32649733,An exploratory Study of EEG Alpha Oscillation and Pupil Dilation in Hearing-Aid Users During Effortful listening to Continuous Speech.,"Individuals with hearing loss allocate cognitive resources to comprehend noisy speech in everyday life scenarios. Such a scenario could be when they are exposed to ongoing speech and need to sustain their attention for a rather long period of time, which requires listening effort. Two well-established physiological methods that have been found to be sensitive to identify changes in listening effort are pupillometry and electroencephalography (EEG). However, these measurements have been used mainly for momentary, evoked or episodic effort. The aim of this study was to investigate how sustained effort manifests in pupillometry and EEG, using continuous speech with varying signal-to-noise ratio (SNR). Eight hearing-aid users participated in this exploratory study and performed a continuous speech-in-noise task. The speech material consisted of 30-second continuous streams that were presented from loudspeakers to the right and left side of the listener (±30° azimuth) in the presence of 4-talker background noise (+180° azimuth). The participants were instructed to attend either to the right or left speaker and ignore the other in a randomized order with two different SNR conditions: 0 dB and -5 dB (the difference between the target and the competing talker). The effects of SNR on listening effort were explored objectively using pupillometry and EEG. The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition. This study demonstrates that both measures are sensitive to changes in SNR during continuous speech.",2020,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"['Eight hearing-aid users participated', 'Hearing-Aid Users', 'Individuals with hearing loss allocate cognitive resources']","['EEG Alpha Oscillation and Pupil Dilation', 'continuous speech-in-noise task', 'SNR', 'continuous speech with varying signal-to-noise ratio (SNR']",['mean pupil dilation and decreased EEG alpha power'],"[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0156161,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"[{'ForeName': 'Tirdad', 'Initials': 'T', 'LastName': 'Seifi Ala', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Graversen', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Wendt', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Alickovic', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Whitmer', 'Affiliation': 'Hearing Sciences-Scottish Section, Division of Clinical Neuroscience, University of Nottingham, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lunner', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}]",PloS one,['10.1371/journal.pone.0235782']
1445,32653532,Quantitative Assessment of the Efficacy of Two Different Single-file Systems in Reducing the Bacterial load in Oval-Shaped Canals: A Clinical Study.,"INTRODUCTION


This randomized clinical study compared the in vivo antibacterial efficacy of Reciproc Blue (RB), XP-endo Shaper (XP-S), and XP-endo Shaper associated with XP-endo Finisher (XP-F) systems in infected oval-shaped root canals with primary apical periodontitis.
METHODS


In this study, 28 human teeth with a single root and a single canal were randomly assigned to 2 groups according to the instrumentation technique: group 1, RB (n = 14) and group 2, XP-endo (XP-S and XP-F, n = 14). The single-rooted teeth were prepared by reciprocating and rotary nickel-titanium instruments with 5.25% sodium hypochlorite irrigation. Samples were collected from the canal at the baseline (S1), after chemomechanical preparation (S2), and after XP-F instrumentation (S3). The DNA extracts were subjected to quantitative analysis for total bacterial counts by quantitative real-time polymerase chain reaction. The data were analyzed using the analysis of variance test, and the level of significance was set at 5%.
RESULTS


All samples tested positive for the presence of bacteria at baseline, and the bacterial counts substantially reduced after treatment procedures (P < .01). The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P > .05). A marked bacterial reduction was observed after the use of the XP-F instrument (P < .01).
CONCLUSIONS


The XP-S and RB systems sharply reduced the bacterial load in oval-shaped root canals with primary apical periodontitis. XP-F used as a supplementary instrument to chemomechanical preparation promoted a significantly higher bacterial reduction.",2020,The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P ˃ 0.05).,"['Oval- Shaped Canals', '28 human teeth with a single root and a single canal', 'infected oval-shaped root canals with primary apical periodontitis']","['reciprocating and rotary nickel-titanium (NiTi) instruments with 5.25% sodium hypochlorite irrigation', 'Reciproc Blue (RB), XP-endo Shaper (XP-S),XP-endo Shaper associated with XP-endo Finisher (XP-F) systems']","['bacterial counts', 'bacterial reduction']","[{'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",28.0,0.0301852,The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P ˃ 0.05).,"[{'ForeName': 'Rodrigo Rodrigues', 'Initials': 'RR', 'LastName': 'Amaral', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia; Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. Electronic address: dr.rodrigoamaral@gmail.com.'}, {'ForeName': 'Anna Gabriella', 'Initials': 'AG', 'LastName': 'Guimarães Oliveira', 'Affiliation': 'Laboratory of Oral Microbiology and Anaerobes, Department of Microbiology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Braga', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reher', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'de Macêdo Farias', 'Affiliation': 'Laboratory of Oral Microbiology and Anaerobes, Department of Microbiology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Paula Prazeres', 'Initials': 'PP', 'LastName': 'Magalhães', 'Affiliation': 'Laboratory of Oral Microbiology and Anaerobes, Department of Microbiology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Pedro Gonçalves', 'Initials': 'PG', 'LastName': 'Ferreira', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ilma de Souza Côrtes', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.007']
1446,32618279,"Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.","BACKGROUND


The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules.
METHODS


We did a single-centre, double-blind, randomised controlled, phase 1 trial in healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA. Participants were sequentially enrolled into one of three groups: ZPIV given at weeks 0 and 4 (standard regimen), weeks 0 and 2 (accelerated regimen), or week 0 alone (single-dose regimen). Within each group, participants were randomly assigned using a computer-generated randomisation schedule to receive an intramuscular injection of 5 μg ZPIV or saline placebo, in a ratio of 5:1. The sponsor, clinical staff, investigators, participants, and laboratory personnel were masked to treatment assignment. The primary endpoint was safety up to day 364 after final dose administration, and secondary endpoints were proportion of participants with positive humoral immune responses (50% microneutralisation titre [MN 50 ] ≥100) and geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level observed for an individual participant across all timepoints) and week 28. All participants who received at least one dose of ZPIV or placebo were included in the safety population; the analysis of immunogenicity at observed peak included all participants who received at least one dose of ZPIV or placebo and had any adverse events or immunogenicity data after dosing. The week 28 immunogenicity analysis population consisted of all participants who received ZPIV or placebo and had immunogenicity data available at week 28. This trial is registered with ClinicalTrials.gov, NCT02937233.
FINDINGS


Between Dec 8, 2016, and May 17, 2017, 12 participants were enrolled into each group and then randomly assigned to vaccine (n=10) or placebo (n=2). There were no serious or grade 3 treatment-related adverse events. The most common reactions among the 30 participants who received the vaccine were injection-site pain (24 [80%]), fatigue (16 [53%]), and headache (14 [46%]). A positive response at observed peak titre was detected in all participants who received ZPIV via the standard regimen, in eight (80%) of ten participants who received ZPIV via the accelerated regimen, and in none of the ten participants who received ZPIV via the single-dose regimen. The geometric mean of all individual participants' observed peak values was 1153·9 (95% CI 455·2-2925·2) in the standard regimen group, 517·7 (142·9-1875·6) in the accelerated regimen group, and 6·3 (3·7-10·8) in the single-dose regimen group. At week 28, a positive response was observed in one (13%) of eight participants who received ZPIV via the standard regimen and in no participant who received ZPIV via the accelerated (n=7) or single-dose (n=10) regimens. The geomteric mean titre (GMT) at this timepoint was 13·9 (95% CI 3·5-55·1) in the standard regimen group and 6·9 (4·0-11·9) in the accelerated regimen group; antibody titres were undetectable at 28 weeks in participants who received ZPIV via the single-dose regimen. For all vaccine schedules, GMTs peaked 2 weeks after the final vaccination and declined to less than 100 by study week 16. There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
INTERPRETATION


ZPIV was safe and well tolerated in humans up to 52 weeks of follow-up. ZPIV immunogenicity required two doses and was not durable. Additional studies of ZPIV to optimise dosing schedules are ongoing.
FUNDING


The Henry M Jackson Foundation for the Advancement of Military Medicine.",2020,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","['healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA']","['intramuscular injection of 5 μg ZPIV or saline placebo', 'ZPIV or placebo', 'Zika purified inactivated virus vaccine', 'vaccine', 'ZPIV', 'placebo']","['headache', 'Safety and immunogenicity', 'fatigue', 'ZPIV immunogenicity', 'geomteric mean titre (GMT', 'injection-site pain', 'adverse events or immunogenicity data', 'safety and immunogenicity', 'proportion of participants with positive humoral immune responses', 'serious or grade 3 treatment-related adverse events', ' antibody titres', 'geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level', 'positive response', 'peak titre', 'observed peak GMTs']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.542669,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA; Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Moseley', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30085-2']
1447,32619212,"Contrasting effects of viscous and particulate fibers on colonic fermentation in vitro and in vivo, and their impact on intestinal water studied by MRI in a randomized trial.","BACKGROUND


Wheat bran, nopal, and psyllium are examples of particulate, viscous and particulate, and viscous fibers, respectively, with laxative properties yet contrasting fermentability.
OBJECTIVES


We assessed the fermentability of these fibers in vitro and their effects on intestinal function relevant to laxation in vivo using MRI.
METHODS


Each fiber was predigested prior to measuring gas production in vitro during 48-h anaerobic incubation with healthy fecal samples. We performed a randomized, 3-way crossover trial in 14 healthy volunteers who ingested 7.5 g fiber twice on the day prior to study initiation and once with the study test meal. Serial MRI scans obtained after fasting and hourly for 4 h following meal ingestion were used to assess small bowel water content (SBWC), colonic volumes, and T1 of the ascending colon (T1AC) as measures of colonic water. Breath samples for hydrogen analysis were obtained while patients were in the fasted state and every 30 min for 4 h following meal ingestion.
RESULTS


In vitro, the onset of gas production was significantly delayed with psyllium (mean ± SD: 14 ± 5 h) compared with wheat bran (6 ± 2 h, P = 0.003) and was associated with a smaller total gas volume (P = 0.01). Prefeeding all 3 fibers for 24 h was associated with an increased fasting T1AC (>75% of values >90th centile of the normal range). There was a further rise during the 4 h after psyllium (0.3 ± 0.3 s P = 0.009), a fall with wheat bran (-0.2 ± 0.2 s; P = 0.02), but no change with nopal (0.0 ± 0.1 s, P = 0.2). SBWC increased for all fibers; nopal stimulated more water than wheat bran [AUC mean (95% CI) difference: 7.1 (0.6, 13.8) L/min, P = 0.03].Breath hydrogen rose significantly after wheat bran and nopal but not after psyllium (P < 0.0001).
CONCLUSION


Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber. This trial was registered at clinicaltrials.gov as NCT03263065.",2020,Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber.,['14 healthy volunteers who ingested 7.5 g fiber twice on the day prior to study initiation and once with the study test meal'],['viscous and particulate fibers'],"['increased fasting T1AC', 'onset of gas production', 'SBWC', 'smaller total gas volume', 'small bowel water content (SBWC), colonic volumes, and T1 of the ascending colon (T1AC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0227375', 'cui_str': 'Ascending colon structure'}]",14.0,0.0430021,Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gunn', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Murthy', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Major', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wilkinson-Smith', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hoad', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Remes-Troche', 'Affiliation': 'Digestive Physiology and Motility Lab, Medical Biological Research Institute, University of Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Harris', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ahn-Jarvis', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Warren', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Spiller', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa173']
1448,32684362,"Conjugated linoleic acid supplements preserve muscle in high-body-fat adults: A double-blind, randomized, placebo trial.","BACKGROUND AND AIMS


Conjugated linoleic acid (CLA) has been used to improve body composition in weight management. However, clinical trial results are inconsistent and limited among Asians. We aimed to investigate the effect of CLA on body composition of Chinese adults with elevated body fat percentage.
METHODS AND RESULTS


In this double-blind, randomized, placebo-controlled trial, 66 Chinese adults (aged 18-45 years old, 37.9% male) with elevated body fat percentage were provided with 3.2 g/day CLA (n = 33) or 3.2 g/day placebo (sunflower oil; n = 33) for 12 weeks. Both groups received lifestyle counseling, featured with low fat and low sugar diet, and moderate physical activity. Body composition was measured using dual-energy X-ray absorptiometry at the baseline and end of the trial. Sixty-four participants finished this study. Compared with the placebo group, the CLA group showed increased trunk muscle mass (MM) (0.6 ± 1.7 vs. -0.3 ± 1.2 kg, P = 0.019). Among those with an adherence score higher than 0.80 (n = 56, 87.5%), a greater increase in both total and trunk MM was observed in the CLA group (both P < 0.05). Moreover, the effect on MM appeared to be more evident in men, those with a body mass index <25 kg/m 2 , or those with higher self-rated physical activity.
CONCLUSIONS


In Chinese adults with elevated body fat percentage, 3.2 g/day CLA supplementation may be effective in preserving MM, especially in the trunk region.
REGISTRATION


This study was registered at ClinicalTrials.gov as NCT03915808 on April 9, 2019.",2020,"Compared with the placebo group, the CLA group showed increased trunk muscle mass (MM) (0.6 ± 1.7 vs. -0.3 ± 1.2 kg, P = 0.019).","['high-body-fat adults', 'Chinese adults with elevated body fat percentage', '66 Chinese adults (aged 18-45 years old, 37.9% male) with elevated body fat percentage were provided with 3.2\xa0g/day']","['CLA', 'CLA supplementation', 'placebo', 'lifestyle counseling, featured with low fat and low sugar diet', 'Conjugated linoleic acid supplements', 'Conjugated linoleic acid (CLA']","['total and trunk MM', 'trunk muscle mass (MM', 'Body composition']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}]","[{'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0452316', 'cui_str': 'Low sugar diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",66.0,0.699676,"Compared with the placebo group, the CLA group showed increased trunk muscle mass (MM) (0.6 ± 1.7 vs. -0.3 ± 1.2 kg, P = 0.019).","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gan', 'Affiliation': 'Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, OX3 7LF, UK; Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': ""Department of Nutrition, The First Affiliated Hospital, Xi'an Jiaotong University Health Science Center, 277 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Junxiang', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Mengnan', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Huangtao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shenglong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""School of Sports and Health Sciences, Xi'an Physical Education University, 65 North Hanguang Road, 710068, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China. Electronic address: yuyan@xjtu.edu.cn.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, 76 West Yanta Road, 710061, Xi'an, Shaanxi, China. Electronic address: xinliu@xjtu.edu.cn.""}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.05.029']
1449,32621900,Comparison of Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs in Terms of Visual Outcome: a Paired Contralateral Eye Study.,"PURPOSE


This study sought to compare the postoperative visual outcomes of toric implantable collamer lens (T-ICL) with toric Artiflex (T-Artiflex) lenses.
DESIGN


Alternating treatment, contralateral eye matched clinical study.
METHODS


This study compared 82 eyes of 41 patients with T-ICL lenses in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism. Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events were assessed at least 12 months postoperatively.
RESULTS


After a mean follow-up of 12 months, the safety index was mean 1.40 ± 0.70 in the T-ICL group and 1.20 ± 0.21 in the T-Artiflex group. Furthermore, their mean efficacy indexes were 1.24 ± 0.42 and 1.08 ± 0.23, respectively (P = .029). A total of 39 eyes (95%) in the T-ICL group and 41 eyes (100%) in the T-Artiflex group were within ±1.00 diopter (D) of emmetropia and 33 eyes (80%) and 34 eyes (83%) were within ±0.5 D of emmetropia, respectively. Vector analysis revealed mean index of success as large as 0.25 ± 0.22 in the T-ICL group and 0.24 ± 0.15 in the T-Artiflex group. Postoperative contrast sensitivities were equal in both groups under mesopic conditions for any given spatial frequency. There was an endothelial loss of 2.18% and 1.95% in the T-ICL and T-Artiflex groups, respectively. There were no significant complications in any of the groups.
CONCLUSIONS


Both lenses showed promising results in terms of safety, efficacy, and predictability for correction of myopic astigmatism. As shown in this paired-eye study, most outcomes were almost identical, and neither of these lenses were clinically superior to the other.",2020,"There was no significant complication in any of the groups.
",['82 eyes of 41 patients with toric ICL implantation in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism'],"['Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs', 'toric implantable collamer lens (T-ICL) and toric Artiflex (T-Artiflex) implantation']","['mean efficacy index', 'safety index', 'endothelial cell loss', 'Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events', 'mean index of success', 'safety, efficacy, and predictability']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",41.0,0.0443315,"There was no significant complication in any of the groups.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghoreishi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran; Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Kashfi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran. Electronic address: drkashfi@gmail.com.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Peyman', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Mohammadinia', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.021']
1450,32627952,Exercise Training Alters Red Blood Cell Fatty Acid Desaturase Indices and Adipose Tissue Fatty Acid Profile in African Women with Obesity.,"OBJECTIVE


This study assessed the changes in red blood cell total phospholipid (RBC-TPL) and subcutaneous adipose tissue (SAT) fatty acid (FA) composition in response to 12 weeks of exercise training in South African women with obesity and the associations with changes in cardiometabolic risk factors.
METHODS


Previously sedentary women were randomized into control (n = 15) or exercise (n = 20) groups. RBC-TPL and SAT FA profiles, SAT gene expression, systemic inflammatory markers, liver fat, and insulin sensitivity (S I  ) were measured before and after the intervention.
RESULTS


Compared with control, exercise training induced decreases in RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity (P < 0.05). In the combined group, these changes correlated with changes in circulating leptin and TNFα (P < 0.05), as well as lower liver fat (P < 0.01). Exercise training decreased saturated FA (lauric and myristic acids) and increased polyunsaturated FA (eicosadienoic and adrenic acids) (P < 0.05) in abdominal SAT, whereas γ-linolenic acid decreased (P < 0.01) in gluteal SAT. These changes in RBC-TPL and SAT FA compositions were not associated with changes in SAT gene expression and S I  .
CONCLUSIONS


Exercise training alters RBC-TPL desaturase activities, which correlate with lower liver fat and systemic inflammation but not with the improvement of S I  .",2020,"Compared with control, exercise training induced decreases in RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity (P < 0.05).","['South African women with obesity and the associations with changes in cardiometabolic risk factors', 'Previously sedentary women', 'African Women with Obesity']","['exercise training', 'Exercise Training', 'Exercise training', 'control, exercise training']","['saturated FA (lauric and myristic acids) and increased polyunsaturated FA (eicosadienoic and adrenic acids', 'RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity', 'RBC-TPL and SAT FA profiles, SAT gene expression, systemic inflammatory markers, liver fat, and insulin sensitivity (S I  ', 'RBC-TPL desaturase activities', 'lower liver fat and systemic inflammation', 'lower liver fat', 'circulating leptin and TNFα', 'γ-linolenic acid', 'red blood cell total phospholipid (RBC-TPL) and subcutaneous adipose tissue (SAT) fatty acid (FA) composition', 'RBC-TPL and SAT FA compositions']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0027138', 'cui_str': 'Myristic acid'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1168488', 'cui_str': 'Total phospholipids'}, {'cui': 'C0000658', 'cui_str': '8,11,14-eicosatrienoic acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038233', 'cui_str': 'Acyl-CoA desaturase'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0190263,"Compared with control, exercise training induced decreases in RBC-TPL dihomo-γ-linolenic acid content and stearoyl-CoA desaturase-1 and increased delta-5 desaturase-estimated activity (P < 0.05).","[{'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Nono Nankam', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'van Jaarsveld', 'Affiliation': 'Non-communicable Diseases Research Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Adams', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melony C', 'Initials': 'MC', 'LastName': 'Fortuin-de Smidt', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Clamp', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Endocrinology, Faculty of Medicine, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22862']
1451,32623059,Applying an immersive tutorial in virtual reality to learning a new technique.,"OBJECTIVE


The medical world is continuously evolving, with techniques being created or improved almost daily. Immersive virtual reality (VR) is a technology that could be harnessed to develop tools that meet the educational challenges of this changing environment. We previously described the immersive tutorial, a 3D video (filmed from the first-person point of view), displayed on a VR application. This tool offers access to supplementary educational data in addition to the video. Here we attempt to assess improvement in learning a technique using this new educational format.
MATERIAL AND METHODS


We selected a single neurosurgical technique for the study: external ventricular drainage. We wrote a technical note describing this procedure and produced the corresponding immersive tutorial. We conducted a prospective randomized comparative study with students. All participants read the technical note, and one group used the immersive tutorial as a teaching supplement. The students completed a multiple-choice questionnaire immediately after the training and again at six months.
RESULTS


One hundred seventy-six fourth-year medical students participated in the study; 173 were included in assessing the immediate learning outcomes and 72 were included at the six-month follow-up. The VR group demonstrated significantly better short-term results than the control group (P=0.01). The same trend was seen at six months.
CONCLUSION


To our knowledge, this study presents one of the largest cohorts for VR. The use of the immersive tutorial could enable a large number of healthcare professionals to be trained without the need for expensive equipment.",2020,The VR group demonstrated significantly better short-term results than the control group (p = 0.01).,"['students', 'One hundred seventy-six fourth-year medical students participated in the study; 173 were included in assessing the immediate learning outcomes and 72 were included at the six-month follow-up']",['Immersive virtual reality (VR'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]",[],,0.021312,The VR group demonstrated significantly better short-term results than the control group (p = 0.01).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ros', 'Affiliation': 'Education sciences school - LIRDEF, Montpellier university 3, 2, place Marcel-Godechot, 34000 Montpellier, France. Electronic address: maximeros@gmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Debien', 'Affiliation': ""Medical simulation training center, 641, avenue du Doyen Gaston-Giraud, 34090 Montpellier, France; Montpellier medical school, 2, rue de l'École de Médecine, 34090 Montpellier, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cyteval', 'Affiliation': ""Radiology department, Lapeyronie hospital, 371, avenue du Doyen Gaston-Giraud, 34090 Montpellier, France; Montpellier medical school, 2, rue de l'École de Médecine, 34090 Montpellier, France.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Molinari', 'Affiliation': ""IT medical department, Lapeyronie hospital, 371, avenue du Doyen Gaston-Giraud, 34090 Montpellier, France; Montpellier medical school, 2, rue de l'École de Médecine, 34090 Montpellier, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gatto', 'Affiliation': 'Education sciences school - LIRDEF, Montpellier university 3, 2, place Marcel-Godechot, 34000 Montpellier, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lonjon', 'Affiliation': ""Neurosurgery department, Gui de Chauliac hospital, 80, avenue Augustin-Fliche, 34295 Montpellier, France; Montpellier medical school, 2, rue de l'École de Médecine, 34090 Montpellier, France.""}]",Neuro-Chirurgie,['10.1016/j.neuchi.2020.05.006']
1452,32623608,"The MelFo Study UK: Effects of a Reduced-Frequency, Stage-Adjusted Follow-Up Schedule for Cutaneous Melanoma 1B to 2C Patients After 3-Years.","BACKGROUND


Evidence-based guidelines for follow-up treatment of American Joint Committee on Cancer (AJCC) stages 1B to 2C melanoma patients are lacking. The MELanoma FOllow-up study is an international phase 3 randomized trial, and the 3-year interim data were recently reported from the Netherlands. The study was undertaken concurrently with a British cohort for comparison and validation of the Dutch study.
METHODS


The study enrolled and stratified 207 patients by AJCC stage. The conventional schedule group (CSG; n = 103) cohort was reviewed as per UK guidelines. The experimental schedule group (ESG; n = 104) cohort was reviewed in a reduced-frequency nurse-led, consultant-supervised clinic. Quality of life (QoL) was measured at baseline (T1), a 1 year (T2), and at 3 years (T3) using the State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS) of the RAND-36.
RESULTS


Of the 207 QoL questionnaires, 170 (82.1%) were completed at T3. Both cohorts expressed high satisfaction (> 93%) with their regimens. At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols. Recurrence had developed in 33 patients Conventional follow-up (CFU), 16 [15.5%]; Experimental follow-up (EFU), 17 [16.3%]. Self-examination was the method of detection for 12 ESG patients (70.6%) and 11 CSG patients (68.8%). The melanoma-specific survival was identical.
CONCLUSION


The UK 3-year data were consistent with the previous Dutch report. The reduced follow-up strategy was shown to be safe, with significant resource usage benefits for national cancer services. Patient anxiety levels were not increased by a less-intensive follow-up regimen, and acceptance was high. The study data indicate that patient self-examination is very effective for recurrence detection.",2020,"At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols.","['British cohort for comparison and validation of the Dutch study', '207 patients by AJCC stage', 'Cutaneous Melanoma 1B to 2C Patients After 3-Years']","['Reduced-Frequency, Stage-Adjusted Follow-Up Schedule']","['Patient anxiety levels', 'Recurrence', 'State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS', 'Quality of life (QoL', 'melanoma-specific survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",207.0,0.0716703,"At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols.","[{'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Moncrieff', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK. marc.moncrieff@nnuh.nhs.uk.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Underwood', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Garioch', 'Affiliation': 'Department of Dermatology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heaton', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Nakul', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Bastiaannet', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Josette E H M', 'Initials': 'JEHM', 'LastName': 'Hoekstra-Weebers', 'Affiliation': 'University Medical Center Groningen, Wenckebach Institute, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Harald J', 'Initials': 'HJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Annals of surgical oncology,['10.1245/s10434-020-08758-2']
1453,32624472,"Is reduction of routine radiograph use in patients with distal radius fractures cost effective? Analysis of data from the multicentre, randomised controlled WARRIOR trial.","OBJECTIVE


To assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care.
DESIGN


An economical evaluation conducted alongside a multicentre randomised controlled trial (RCT).
SETTING


Four level-one trauma centres in the Netherlands.
PARTICIPANTS


341 patients participated (usual care (n=172), reduced imaging (n=169)).
INTERVENTIONS


Patients were randomised to usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication).
OUTCOME MEASURES


Functional outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L). Costs were measured using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation, seemingly unrelated regression analysis and bootstrapping were used to analyse the data.
RESULTS


Clinical overall outcomes of both groups were comparable. The difference in DASH was -2.03 (95% CI -4.83 to 0.77) and the difference in QALYs was 0.025 (95% CI -0.01 to 0.06). Patients in the reduced imaging group received on average 3.3 radiographs (SD: 1.9) compared with 4.2 (SD: 1.9) in the usual care group. Costs for radiographic imaging were significantly lower in the reduced imaging group than in the usual care group (€-48 per patient, 95% CI -68 to -27). There was no difference in total costs between groups (€-401 per patient, 95% CI -2453 to 1251). The incremental cost-effectiveness ratio (ICER) for QALYs was -15 872; the ICER for the DASH was 198. The probability of reduced imaging being cost effective compared with usual care ranged from 0.8 to 0.9 at a willingness to pay of €20 000/QALY to €80 000/QALY.
CONCLUSIONS


Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome. We, therefore, recommend imaging only when clinically indicated.
TRIAL REGISTRATION NUMBER


The Netherlands trial register (NL4477).",2020,"Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome.","['341 patients participated (usual care (n=172), reduced imaging (n=169', 'patients with distal radius fractures', 'Four level-one trauma centres in the Netherlands']","['usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication']","['total costs', 'Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L', 'DASH', 'cost effectiveness', 'Costs for radiographic imaging', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0457276', 'cui_str': 'Radiographic imaging - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",341.0,0.158822,"Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'van Gerven', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands p.van_gerven@lumc.nl.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Sidney M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marco F', 'Initials': 'MF', 'LastName': 'Termaat', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'El Moumni', 'Affiliation': 'Trauma Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wietse P', 'Initials': 'WP', 'LastName': 'Zuidema', 'Affiliation': 'Trauma Surgery, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Pieta', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Inger B', 'Initials': 'IB', 'LastName': 'Schipper', 'Affiliation': 'Trauma Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035370']
1454,32624473,Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial.,"INTRODUCTION


Preliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.
METHODS AND ANALYSIS


We propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.
ETHICS AND DISSEMINATION


This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People's Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.
TRIAL REGISTRATION NUMBER


NCT03936504.",2020,"The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination.","['chronic coronary syndrom patients', '150 participants with CCS', 'patients with chronic coronary syndrom (CCS']","['innovative Tai Chi Cardiac Rehabilitation Program (TCCRP', 'supervised conventional exercise rehabilitation', 'Tai Chi-based cardiac rehabilitation programme', 'Tai Chi exercise']","['body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination', 'Safety and effectiveness', 'Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale', 'efficacy, safety and acceptability', 'score of 36-Item Short Form Survey and Chinese Perceived Stress Scale']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C1997846', 'cui_str': 'Heart rate recovery time'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",150.0,0.127198,"The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Cardiology, First Medical Center of Chinese People's Libration Army General Hospital, Beijing, China.""}, {'ForeName': 'Jian Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Medicine, Anzhen Community Health Service Center, Chaoyang District, Beijing, China.'}, {'ForeName': 'Lian Shan', 'Initials': 'LS', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Medicine, Beijing Shuili Hospital, Beijing, China.'}, {'ForeName': 'Ai Ying', 'Initials': 'AY', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiovascular Medicine, Anzhen Community Health Service Center, Chaoyang District, Beijing, China.'}, {'ForeName': 'Zai Hao', 'Initials': 'ZH', 'LastName': 'Chen', 'Affiliation': 'College of Wushu, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'College of Wushu, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Tian Ming', 'Initials': 'TM', 'LastName': 'Gao', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Ya Meng', 'Initials': 'YM', 'LastName': 'Li', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Cui Han', 'Initials': 'CH', 'LastName': 'Li', 'Affiliation': 'College of Wushu, Beijing Sport University, Beijing, China.'}, {'ForeName': 'Hong Wei', 'Initials': 'HW', 'LastName': 'Wang', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Yu Long', 'Initials': 'YL', 'LastName': 'Lu', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Mei Ze', 'Initials': 'MZ', 'LastName': 'Cui', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Qiu Yang', 'Initials': 'QY', 'LastName': 'Wei', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shao Jun', 'Initials': 'SJ', 'LastName': 'Lyu', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China l13121860699@163.com shaojunl@hotmail.com yinhengchan@bnu.edu.cn.'}, {'ForeName': 'Heng Chan', 'Initials': 'HC', 'LastName': 'Yin', 'Affiliation': 'College of Physical Education and Sports, Beijing Normal University, Beijing, China l13121860699@163.com shaojunl@hotmail.com yinhengchan@bnu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-036061']
1455,32629997,The UK Pregnancies Better Eating and Activity Trial (UPBEAT); Pregnancy Outcomes and Health Behaviours by Obesity Class.,"The effectiveness of antenatal intervention in women with increasing obesity is unknown. This study investigated whether there was a differential effect of antenatal intervention on diet, physical activity and pregnancy outcomes in women stratified by obesity class using data from the UK Pregnancies Better Eating and Activity Trial (UPBEAT) ( n  = 1555). The stratification was by World Health Organization classifications: Class I, II and III (30-34.9 kg/m 2 , 35-39.9 kg/m 2  and ≥40 kg/m 2 ). Using linear and logistic regression, adjusted for confounders, outcomes were assessed post-intervention (27 +0 -28 +6  weeks' gestation) and in late pregnancy (34 +0 -36 +0  weeks' gestation). Interactions between obesity class and the intervention were explored. Compared to the standard care arm, class III intervention women had lower gestational weight gain (GWG) (-1.87 kg; 95% CI -3.29 to -0.47,  p  = 0.009), and the effect of the intervention was greater in class III compared to class I, by -2.01 kg (95% CI -3.45 to -0.57,  p  = 0.006). Class I and II intervention women reported significantly lower dietary glycaemic load and saturated fat intake across their pregnancy. This differential effect of the intervention suggests antenatal interventions for women with obesity should stratify outcomes by obesity severity. This would inform evidence-based antenatal strategies for high-risk groups, including women with a BMI ≥ 40 kg/m 2 .",2020,"Compared to the standard care arm, class III intervention women had lower gestational weight gain (GWG) (-1.87 kg; 95% CI -3.29 to -0.47,  p  = 0.009), and the effect of the intervention was greater in class III compared to class","['women with obesity', 'women stratified by obesity class using data from the UK Pregnancies Better Eating and Activity Trial (UPBEAT) ( n  = 1555', 'women with increasing obesity is unknown']",['antenatal intervention'],"['gestational weight gain (GWG', 'diet, physical activity and pregnancy outcomes', 'dietary glycaemic load and saturated fat intake']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake'}]",,0.0574858,"Compared to the standard care arm, class III intervention women had lower gestational weight gain (GWG) (-1.87 kg; 95% CI -3.29 to -0.47,  p  = 0.009), and the effect of the intervention was greater in class III compared to class","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Peacock', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}]",International journal of environmental research and public health,['10.3390/ijerph17134712']
1456,32632265,Author Correction: Metacognitive Therapy versus Cognitive Behaviour Therapy in Adults with Major Depression: A Parallel Single-Blind Randomised Trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"['Adults with Major Depression', 'Author Correction']",['Metacognitive Therapy versus Cognitive Behaviour Therapy'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3812881', 'cui_str': 'Author'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0692484,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Callesen', 'Affiliation': 'Cektos - Center for Kognitiv - Og Metakognitiv Terapi, Riddergade 7, 1 sal, 4700, Næstved, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'University of Manchester, NIHR School for Primary Care Research, Manchester Academic Health Sciences Centre, Williamson Building, Manchester, M13 9PL, UK.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'University of Manchester, Centre for Biostatistics, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, Manchester, M13 9PL, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'University of Manchester, School of Psychological Sciences, Faculty of Biology, Medicine and Health, Rawnsley Building, MRI, Manchester, M13 9WL, UK. adrian.wells@manchester.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-68559-1']
1457,32634745,"Examining sex, adverse childhood experiences, and oxytocin on neuroendocrine reactivity in smokers.","Adverse childhood experiences (ACE) are associated with greater neuroendocrine responses to social stress in substance users. The neuropeptide oxytocin might attenuate this relationship. Given sex differences in ACE exposure and neuroendocrine stress reactivity, it is unknown whether this association is similar for males and females. Therefore, this secondary analysis evaluated the interactive effect of sex, ACE, and acute oxytocin administration on neuroendocrine stress responses in adult cigarette smokers (N = 144). Participants completed the Adverse Childhood Experiences Questionnaire at screening and were randomized to receive intranasal oxytocin or placebo before undergoing the Trier Social Stress Task (TSST). Cortisol levels were assessed at pre- and post-medication administration and at 20 and 40 min following the TSST. Generalized linear mixed models were developed to predict post-TSST cortisol levels. Predictors included treatment assignment (placebo vs. oxytocin), sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration. The hypothesized three-way interaction between sex, oxytocin, and ACE scores was significant. Linear associations between ACE scores and cortisol reactivity indicated higher ACE scores were associated with attenuated cortisol response in females, regardless of treatment condition. For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin. Results indicate that the association between ACE and neuroendocrine reactivity to social stress, as well as the attenuating effect of oxytocin, is differentially impacted by sex. Males with greater childhood adversity may be more likely to benefit from oxytocin's anxiolytic properties.",2020,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","['adult cigarette smokers (N\u2009=\u2009144', 'smokers', 'Participants completed the Adverse Childhood Experiences Questionnaire at screening']","['oxytocin', 'treatment assignment (placebo vs. oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin or placebo', 'oxytocin administration']","['sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration', 'cortisol response', 'ACE scores', 'Cortisol levels', 'ACE scores and cortisol reactivity indicated higher ACE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4284014', 'cui_str': 'Adverse Childhood Experience questionnaire'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0291417,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, United States. Electronic address: caitlyn.hood@uky.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Breanna M', 'Initials': 'BM', 'LastName': 'Tuck', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, United States.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States; Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104752']
1458,32636281,"Protocol for a phase IV, open-label feasibility study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving optimised background therapy (OBT) plus maraviroc or OBT alone.","INTRODUCTION


At least 30% of people living with HIV (PLWH) infection have non-alcoholic fatty liver disease (NAFLD), which has now become a leading cause of hepatic fibrosis and cirrhosis. Management is based largely on lifestyle modifications, which are difficult to achieve, and therapeutic options are urgently needed. Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD. However, dosing is usually two times per day, unlike most currently recommended antiretroviral therapies. This study will investigate the feasibility and acceptability of addition of MVC to combination antiretroviral therapy in PLWH and NAFLD as a treatment for NAFLD.
METHODS AND ANALYSIS


This is a phase IV, randomised, open-label, non-invasive feasibility study. Sixty individuals with well-controlled HIV-1 and NAFLD will be recruited from UK HIV clinics and randomised 1:1 to receive either optimised background therapy (OBT) plus MVC or OBT alone. Follow-up will be every 24 weeks for 96 weeks. The primary outcome measures will include recruitment and retention rates, adverse events and adherence. Secondary outcomes will include changes in markers of hepatic fibrosis, including the Enhanced Liver Fibrosis score, median liver stiffness measurement and controlled attenuation parameter scores on Fibroscan, and quality of life assessments. Analyses will be performed according to intention-to-treat principles. For secondary outcomes, estimated differences and 95% CIs between the groups using a t-method will be presented for continuous variables and as exact 95% binomial CIs for categorical variables.
ETHICS AND DISSEMINATION


Ethical approval was obtained through the London Dulwich UK Research Ethics Committee (reference 17/LO/2093). Results will be disseminated both through community groups and peer-reviewed scientific literature. Trial registration number  SRCTN31461655. EudraCT number 2017-004141-24; Pre-results.",2020,"Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD.","['people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving', 'Sixty individuals with well-controlled HIV-1 and NAFLD will be recruited from UK HIV clinics', 'people living with HIV (PLWH) infection have non-alcoholic fatty liver disease (NAFLD']","['MVC', 'optimised background therapy (OBT) plus MVC or OBT alone', 'optimised background therapy (OBT) plus maraviroc or OBT alone']","['changes in markers of hepatic fibrosis, including the Enhanced Liver Fibrosis score, median liver stiffness measurement and controlled attenuation parameter scores on Fibroscan, and quality of life assessments', 'recruitment and retention rates, adverse events and adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",60.0,0.212247,"Maraviroc (MVC), through antagonism of CCR5 receptors, may reduce hepatic fibrosis progression and could be an effective treatment for NAFLD.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bradshaw', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton daniel.bradshaw2@nhs.net.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Gilleece', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Iga', 'Initials': 'I', 'LastName': 'Abramowicz', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Perry', 'Affiliation': 'Brighton and Sussex Medical School, Brighton, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035596']
1459,32636283,Development of an occupational advice intervention for patients undergoing elective hip and knee replacement: a Delphi study.,"OBJECTIVE


To obtain consensus on the content and delivery of an occupational advice intervention for patients undergoing primary hip and knee replacement surgery. The primary targets for the intervention were (1) patients, carers and employers through the provision of individualised support and information about returning to work and (2) hospital orthopaedic teams through the development of a framework and materials to enable this support and information to be delivered.
DESIGN


Modified Delphi study as part of a wider intervention development study (The Occupational advice for Patients undergoing Arthroplasty of the Lower limb (OPAL) study: Health Technology Assessment Reference 15/28/02) (ISRCTN27426982).
SETTING


Five stakeholder groups (patients, employers, orthopaedic surgeons, general practitioners, allied health professionals and nurses) recruited from across the UK.
PARTICIPANTS


Sixty-six participants.
METHODS


Statements for the Delphi process were developed relating to the content, format, delivery, timing and measurement of an occupational advice intervention. The statements were based on evidence gathered through the OPAL study that was processed using an intervention mapping framework. Intervention content was examined in round 1 and intervention format, delivery, timing and measurement were examined in round 2. In round 3, the developed intervention was presented to the stakeholder groups for comment.
CONSENSUS


For rounds 1 and 2, consensus was defined as 70% agreement or disagreement on a 4-point scale. Statements reaching consensus were ranked according to the distribution of responses to create a hierarchy of agreement. Round 3 comments were used to revise the final version of the developed occupational advice intervention.
RESULTS


Consensus was reached for 36 of 64 round 1 content statements (all agreement). In round 2, 13 questions were carried forward and an additional 81 statements were presented. Of these, 49 reached consensus (44 agreement/5 disagreement). Eleven respondents provided an appraisal of the intervention in round 3.
CONCLUSIONS


The Delphi process informed the development of an occupational advice intervention as part of a wider intervention development study. Stakeholder agreement was achieved for a large number of intervention elements encompassing the content, format, delivery and timing of the intervention. The effectiveness and cost-effectiveness of the developed intervention will require evaluation in a randomised controlled trial.
TRIAL REGISTRATION NUMBER


International Standard Randomised Controlled Trials Number Trial ID: ISRCTN27426982.",2020,"The primary targets for the intervention were (1) patients, carers and employers through the provision of individualised support and information about returning to work and (2) hospital orthopaedic teams through the development of a framework and materials to enable this support and information to be delivered.
","['patients undergoing primary hip and knee replacement surgery', 'Patients undergoing Arthroplasty of the Lower limb (OPAL) study: Health Technology Assessment Reference 15/28/02', 'Five stakeholder groups (patients, employers, orthopaedic surgeons, general practitioners, allied health professionals and nurses) recruited from across the UK', 'patients undergoing elective hip and knee replacement', 'Sixty-six participants']",['occupational advice intervention'],['effectiveness and cost-effectiveness'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039423', 'cui_str': 'Assessment, Biomedical Technology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",81.0,0.0562813,"The primary targets for the intervention were (1) patients, carers and employers through the provision of individualised support and information about returning to work and (2) hospital orthopaedic teams through the development of a framework and materials to enable this support and information to be delivered.
","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baker', 'Affiliation': 'Department of Orthopaedics, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK paul.baker1@nhs.net.'}, {'ForeName': 'Lucksy', 'Initials': 'L', 'LastName': 'Kottam', 'Affiliation': 'Department of Orthopaedics, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Coole', 'Affiliation': 'School of Health Sciences, Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McDaid', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'Department of Orthopaedics, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036191']
1460,32666905,Development and application of an electronic treatment register: a system for enumerating populations and monitoring treatment during mass drug administration.,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration. The electronic treatment register was designed in xlsform, deployed via the SurveyCTO mobile data collection platform, and implemented on smartphones running the Android operating system. The versatile system enables collection of census and treatment status information, facilitates data aggregation and visualisation, and permits real-time feedback loops during implementation of mass drug administration. Here we describe the system's design and use within the DeWorm3 Project and key features, and by sharing the register here, we hope our readers will further explore its use within their research and disease-control activities.",2020,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration.",[],[],[],[],[],[],,0.0575259,"We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration.","[{'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Oswald', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Kennedy', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Farzana', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Saravanakumar Puthupalayam', 'Initials': 'SP', 'LastName': 'Kaliappan', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Eloic', 'Initials': 'E', 'LastName': 'Atindegla', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Parfait', 'Initials': 'P', 'LastName': 'Houngbégnon', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chisambi', 'Affiliation': 'Blantyre Institute for Community Outreach, Lions Sight First Eye Hospital , Blantyre, Malawi.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Witek-McManus', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine , London, UK.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Galagan', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Emmanuel-Fabula', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Gwayi-Chore', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Legge', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Yard', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Lions Sight First Eye Hospital , Blantyre, Malawi.'}, {'ForeName': 'Moudachirou', 'Initials': 'M', 'LastName': 'Ibikounlé', 'Affiliation': 'Institut de Recherche Clinique du Bénin (IRCB) , Calavi, Benin.'}, {'ForeName': 'Sitara Swarna Rao', 'Initials': 'SSR', 'LastName': 'Ajjampur', 'Affiliation': 'The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College , Vellore, India.'}, {'ForeName': 'Arianna Rubin', 'Initials': 'AR', 'LastName': 'Means', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Kristjana H', 'Initials': 'KH', 'LastName': 'Ásbjörnsdóttir', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Halliday', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}, {'ForeName': 'Judd L', 'Initials': 'JL', 'LastName': 'Walson', 'Affiliation': 'DeWorm3, Division of Life Sciences, Natural History Museum , London, UK.'}]",Global health action,['10.1080/16549716.2020.1785146']
1461,32664047,"Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.",,2014,,['patients receiving high-dose'],"['cisplatin', 'single-dose fosaprepitant', 'placebo']","['nausea and vomiting', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2349941', 'cui_str': 'fosaprepitant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.638118,,[],Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt534']
1462,32687741,Age- and Weight-Adapted Dose of Prasugrel Versus Standard Dose of Ticagrelor in Patients With Acute Coronary Syndromes : Results From a Randomized Trial.,"BACKGROUND


The efficacy and safety of a reduced dose of prasugrel versus a standard dose of ticagrelor in elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS) are unknown.
OBJECTIVE


To investigate the effect of an age- and weight-adapted dose of prasugrel versus a standard dose of ticagrelor in patients with ACS. (ClinicalTrials.gov: NCT01944800).
DESIGN


Prespecified analysis of the multicenter, randomized ISAR-REACT 5 trial.
SETTING


23 centers in Germany and Italy.
PATIENTS


3997 patients with ACS planned for invasive management.
INTERVENTION


Participants were randomly assigned to receive a standard dose of ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group).
MEASUREMENTS


The efficacy end point was a composite of death, myocardial infarction, or stroke, and the safety end point was bleeding, both at 12 months.
RESULTS


In the elderly or low-weight group, the efficacy end point occurred in 12.7% of patients assigned to receive prasugrel and 14.6% of those assigned to receive ticagrelor (hazard ratio [HR], 0.82 [95% CI, 0.60 to 1.14]); in the neither elderly nor low-weight group, the efficacy end point occurred in 4.8% of patients assigned to receive prasugrel and 7.3% of those assigned to receive ticagrelor (HR, 0.65 [CI, 0.48 to 0.88];  P  for interaction > 0.2). In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47];  P  for interaction > 0.2).
LIMITATION


The study is a subgroup analysis.
CONCLUSION


In elderly or low-weight patients with ACS, a reduced dose of prasugrel compared with the standard dose of ticagrelor is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk for bleeding.
PRIMARY FUNDING SOURCE


German Center for Cardiovascular Research and Deutsches Herzzentrum München.",2020,"In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47];  P  for interaction > 0.2).
","['23 centers in Germany and Italy', 'Patients With Acute Coronary Syndromes', 'elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS', 'patients with ACS', '3997 patients with ACS planned for invasive management', 'In elderly or low-weight patients with ACS']","['Prasugrel Versus Standard Dose of Ticagrelor', 'prasugrel', 'ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group', 'ticagrelor']","['efficacy end point', 'composite of death, myocardial infarction, or stroke, and the safety end point was bleeding']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",3997.0,0.113308,"In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47];  P  for interaction > 0.2).
","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'Ospedale Fabrizio Spaziani, Cardiology, Frosinone, Italy (M.M.).'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany (F.N., D.T.).'}, {'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Medical Campus Lake Constance, Friedrichshafen, Germany (J.W.).'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (I.B.).'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center Bad Segeberg, Bad Segeberg, Germany (G.R.).'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Helios Amper-Klinikum Dachau, Dachau, Germany (B.W.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'Klinik der Universität München, Ludwig-Maximilians-Universität, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (D.S.).'}, {'ForeName': 'Senta', 'Initials': 'S', 'LastName': 'Gewalt', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, Florida (D.J.A.).'}, {'ForeName': 'Shqipdona', 'Initials': 'S', 'LastName': 'Lahu', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, Germany (C.W.H.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, School of Medicine, Institute of Medical Informatics, Statistics and Epidemiology, Munich, Germany (A.H.).'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany (F.N., D.T.).'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I, Klinikum rechts der Isar, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (K.L.).'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (H.S., S.S., A.K.).'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (H.S., S.S., A.K.).'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (H.S., S.S., A.K.).'}]",Annals of internal medicine,['10.7326/M20-1806']
1463,32669916,Erratum: Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study [Corrigendum].,[This corrects the article DOI: 10.2147/DNND.S76523.].,2015,[This corrects the article DOI: 10.2147/DNND.S76523.].,"['subjects with progressive multiple sclerosis', 'Erratum']",['Multimodal intervention'],['fatigue and quality of life'],"[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0159325,[This corrects the article DOI: 10.2147/DNND.S76523.].,[],Degenerative neurological and neuromuscular disease,['10.2147/DNND.S94278']
1464,32628922,"Incidence and Outcome of Uveitic Glaucoma in Eyes With Intermediate, Posterior, or Panuveitis Followed up to 10 Years After Randomization to Fluocinolone Acetonide Implant or Systemic Therapy.","PURPOSE


To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, ""implant"") therapy.
DESIGN


Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort.
METHODS


Patients with intermediate, posterior, or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome.
RESULTS


Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P < .001). Adjustment for intraocular pressure (IOP) elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR = 3.1 (95% CI 1.6, 6.0); P = .001. Among 112 eyes of 83 patients developing glaucoma, the 5-year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI 12%, 33%); 5-year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI 17%, 39%).
CONCLUSIONS


The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.",2020,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","['eyes with intermediate, posterior, and panuveitis managed with systemic or', '112 eyes of 83 patients developing glaucoma', 'Multicenter Uveitis Steroid Treatment (MUST', ' Patients with intermediate, posterior or panuveitis randomized to', 'eyes with intermediate, posterior or panuveitis followed up to 10 years after randomization to']","['systemic therapy', 'implant or systemic therapy (corticosteroid plus immunosuppression', 'fluocinolone acetonide', 'fluocinolone acetonide implant or systemic therapy']","['IOP elevation', 'sustained worsening of cup-to-disc ratio', 'uveitic glaucoma']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C1281939', 'cui_str': 'Uveitic glaucoma'}]",83.0,0.167216,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA; The MyungSung Christian Medical Center (MCM) Eye Unit, MCM General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia. Electronic address: john_kempen@meei.harvard.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Friedman', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'Ophthalmology Consultants of Boston, Boston, Massachusetts, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dunn', 'Affiliation': 'Mid-Atlantic Retina, Philadelphia, Pennsylvania, USA; The Wills Eye Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Elner', 'Affiliation': 'The Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'The Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; The Johns Hopkins University School of Medicine Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.038']
1465,32631152,Intradetrusor OnabotulinumtoxinA Injections Ameliorate Autonomic Dysreflexia while Improving Lower Urinary Tract Function and Urinary Incontinence-Related Quality of Life in Individuals with Cervical and Upper Thoracic Spinal Cord Injury.,"Pilot data of our phase IV clinical trial (pre/post study design) highlighted a beneficial effect of intradetrusor onabotulinumtoxinA (200 IU) injections to reduce autonomic dysreflexia (AD) in individuals with chronic spinal cord injury (SCI) at T6 or above. After trial completion, we assessed whether our primary expectation (i.e., decrease of AD severity in 50% of participants during urodynamics [UDS]) was met. Secondary outcome measures were reduction of spontaneous AD in daily life as well as amelioration of AD-related and urinary incontinence-related quality of life (QoL). In addition, we conducted injury-level-dependent analysis-i.e., cervical and upper thoracic-to explore group-specific treatment efficacy. Post-treatment, AD severity decreased in 82% (28/34) of all participants during UDS and in 74% (25/34) in daily life assessed with 24-h ambulatory blood pressure monitoring. In addition, urinary incontinence-related QoL was improved, cystometric capacity was increased, and maximum detrusor pressure during storage was reduced (all  p  < 0.001). Further, the treatment was well tolerated, with only minor complications (grade I [ n  = 7] and II [ n  = 7]) in accordance with the Clavien-Dindo classification recorded in 11 individuals (cervical  n  = 9, upper thoracic  n  = 2). Injury-level-dependent analysis revealed lower incidence (cervical  n  = 15/23, upper thoracic  n  = 6/11) and lesser severity (cervical  p  = 0.009; upper thoracic  p  = 0.06 [Pearson  r  = -0.6, i.e., large effect size]) of AD during UDS. Further, reduced AD severity in daily life, improved urinary incontinence-related QoL, greater cystometric capacity, and lower maximum detrusor pressure during storage (all  p  < 0.05) were found in both groups post-treatment. Intradetrusor onabotulinumtoxinA injections are an effective and safe second-line treatment option that ameliorates AD while improving lower urinary tract function and urinary incontinence-related QoL in individuals with cervical and upper thoracic SCI.",2020,"Additionally, urinary incontinence-related QoL was improved (all p<0.001), cystometric capacity was increased and maximum storage detrusor pressure (both p<0.001) was reduced.","['individuals with cervical and upper thoracic SCI', 'individuals with cervical and upper thoracic spinal cord injury', 'individuals with chronic spinal cord injury (SCI) at T6 or above']",['intradetrusor onabotulinumtoxinA (200 IU) injections'],"['AD severity', 'daily life assessed with 24-hour ambulatory blood pressure monitoring', 'autonomic dysreflexia (AD', 'cystometric capacity', 'reduced AD severity in daily life, improved urinary incontinence-related QoL, greater cystometric capacity, and lower maximum storage detrusor pressure', 'urinary tract function and urinary incontinence-related quality of life', 'urinary incontinence-related QoL', 'maximum storage detrusor pressure', 'spontaneous AD in daily life, amelioration of AD and urinary incontinence-related quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0228625', 'cui_str': 'Structure of upper thoracic spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0238015', 'cui_str': 'Autonomic dysreflexia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure'}, {'cui': 'C0042031', 'cui_str': 'Urinary tract function'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",,0.20053,"Additionally, urinary incontinence-related QoL was improved (all p<0.001), cystometric capacity was increased and maximum storage detrusor pressure (both p<0.001) was reduced.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Kran', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Ramirez', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rapoport', 'Affiliation': 'Department of Urologic Sciences, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Nigro', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Stothers', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Urologic Sciences, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andrei V', 'Initials': 'AV', 'LastName': 'Krassioukov', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of neurotrauma,['10.1089/neu.2020.7115']
1466,32634820,Serial assessment of fat and fat-free mass accretion in very preterm infants: a randomized trial.,"BACKGROUND


Clinicians could modify dietary interventions during early infancy by monitoring fat and fat-free mass accretion in very preterm infants.
METHODS


Preterm infants were randomly assigned to either having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group). All infants underwent serial assessments of body composition by air-displacement plethysmography before 32 weeks of postmenstrual age (PMA) and at 36 weeks PMA. The primary outcome was percent body fat (%BF) at 3 months of corrected age (CA).
RESULTS


Fifty infants were randomized (median gestational age: 30 weeks; mean ± SD birth weight: 1387 ± 283 g). The mean %BF increased from 7 ± 4 before 32 weeks PMA to 20 ± 5 at 3 months CA. The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4). Feeding practices and anthropometric measurements during hospitalization did not differ between groups.
CONCLUSIONS


Serial assessments of body composition in both intervention and control groups showed consistent increments in %BF. However, providing this information to clinicians did not influence nutritional practices or growth.
IMPACT


Serial assessments of body composition in preterm infants at 32 and 36 weeks postmenstrual age show consistent increments in % body fat up to 3 months of corrected age. However, providing this information to the clinician did not influence nutritional practices or growth.",2020,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"['very preterm infants', 'Fifty infants were randomized (median gestational age: 30 weeks; mean\u2009±\u2009SD birth weight: 1387\u2009±\u2009283\u2009g', 'Preterm infants', 'preterm infants at 32 and 36 weeks postmenstrual age']","['Serial assessment of fat and fat-free mass accretion', 'having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group']","['body composition', 'mean %BF', 'percent body fat (%BF']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",50.0,0.0677656,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"[{'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA. asalas@peds.uab.edu.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Jerome', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Chandler-Laney', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}]",Pediatric research,['10.1038/s41390-020-1052-x']
1467,32635650,Mind over Matter: Testing the Efficacy of an Online Randomized Controlled Trial to Reduce Distraction from Smartphone Use.,"Evidence suggests a growing call for the prevention of excessive smartphone and social media use and the ensuing distraction that arises affecting academic achievement and productivity. A ten-day online randomized controlled trial with the use of smartphone apps, engaging participants in mindfulness exercises, self-monitoring and mood tracking, was implemented amongst UK university students ( n  = 143). Participants were asked to complete online pre- and post-intervention assessments. Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes. The intervention was not effective in reducing habitual behaviours, nomophobia, or time spent on social media. Mediation analyses demonstrated that: (i) emotional self-awareness but not mindful attention mediated the relationship between intervention effects and smartphone distraction, and (ii) online vigilance mediated the relationship between smartphone distraction and problematic social media use. The present study provides preliminary evidence of the efficacy of an intervention for decreased smartphone distraction and highlights psychological processes involved in this emergent phenomenon in the smartphone literature. Online interventions may serve as complementary strategies to reduce distraction levels and promote insight into online engagement. More research is required to elucidate the mechanisms of digital distraction and assess its implications in problematic use.",2020,Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes.,['UK university students ( n  = 143'],"['smartphone apps, engaging participants in mindfulness exercises, self-monitoring and mood tracking', 'Mind over Matter']","['smartphone distraction and improvement scores', 'habitual behaviours, nomophobia, or time spent on social media']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]",,0.0449527,Results indicated high effect sizes in reduction of smartphone distraction and improvement scores on a number of self-reported secondary psychological outcomes.,"[{'ForeName': 'Melina A', 'Initials': 'MA', 'LastName': 'Throuvala', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Griffiths', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Rennoldson', 'Affiliation': 'Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}, {'ForeName': 'Daria J', 'Initials': 'DJ', 'LastName': 'Kuss', 'Affiliation': 'International Gaming Research Unit, Psychology Department, Nottingham Trent University, Nottingham NG1 4FQ, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17134842']
1468,32636290,"High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study.","INTRODUCTION


The first-line recommended treatment for patients with intermittent claudication (IC) is a supervised exercise programme (SEP), which includes a minimum of 2-hours of exercise per week over a 12-week period. However, provision, uptake and adherence rates for these SEP programmes are poor, with time constraints cited as a common participant barrier. High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier. However, evidence is lacking for the role of HIIT in those with IC. This proof-of-concept study aims to consider the safety, feasibility, tolerability and acceptability of a HIIT programme for patients with IC.
METHODS AND ANALYSIS


This multicentre, single-group, prospective, interventional feasibility study will recruit 40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week. HIIT will involve a supervised programme of 10×1 min high-intensity cycling intervals at 85%-90% peak power output (PPO), interspaced with 10×1 min low intensity intervals at 20%-25% PPO. PPO will be determined from a baseline cardiopulmonary exercise test (CPET) and it is intended that patients will achieve ≥85% of maximum heart rate from CPET, by the end of the second HIIT interval. Primary outcome measures are safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity). Secondary outcomes include patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes.
ETHICS AND DISSEMINATION


Ethical approval was obtained via a local National Health Service research ethics committee (Bradford Leeds - 18/YH/0112) and recruitment began in August 2019 and will be completed in October 2020. Results will be published in peer-reviewed journals and presented at international conferences and are expected to inform a future pilot randomised controlled trial of HIIT versus usual-care SEPs.
TRIAL REGISTRATION NUMBER


NCT04042311; Pre-results.",2020,High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier.,"['patients with intermittent claudication (IC', '40 patients with IC, who will complete 6 weeks of HIIT, 3 times a week', 'patients with IC']","['High INtensity Interval Training', 'supervised exercise programme (SEP', 'HIIT programme', 'High-intensity interval training (HIIT']","['safety (occurrence of adverse events directly related to the study), programme feasibility (including participant eligibility, recruitment and completion rates) and HIIT tolerability (ability to achieve and maintain the required intensity', 'patient acceptability, walking distance, CPET cardiorespiratory fitness measures and quality of life outcomes', 'provision, uptake and adherence rates', 'safety, feasibility, tolerability and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",40.0,0.212284,High-intensity interval training (HIIT) is more time-efficient and therefore has the potential to overcome this barrier.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pymer', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK sean.pymer@hey.nhs.uk.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harwood', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, New South Wales, UK.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Ibeggazene', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'McGregor', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, New South Wales, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Institute of Clinical and Applied Health Research, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Twiddy', 'Affiliation': 'Institute of Clinical and Applied Health Research, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Nicholls', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ingle', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Rooms', 'Affiliation': 'Hull, UK.'}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Chetter', 'Affiliation': 'Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038825']
1469,32636292,"Immediate parent-infant skin-to-skin study (IPISTOSS): study protocol of a randomised controlled trial on very preterm infants cared for in skin-to-skin contact immediately after birth and potential physiological, epigenetic, psychological and neurodevelopmental consequences.","INTRODUCTION


In Scandinavia, 6% of infants are born preterm, before 37 gestational weeks. Instead of continuing in the in-utero environment, maturation needs to occur in a neonatal unit with support of vital functions, separated from the mother's warmth, nutrition and other benefits. Preterm infants face health and neurodevelopment challenges that may also affect the family and society at large. There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth.
METHODS AND ANALYSIS


In this ongoing randomised controlled trial from Stavanger, Norway and Stockholm, Sweden, we are studying 150 infants born at 28+0 to 32+6 gestational weeks, randomised to receive care immediately after birth in SSC with a parent or conventionally in an incubator. The primary outcome is cardiorespiratory stability according to the stability of the cardiorespiratory system in the preterm score. Secondary outcomes are autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health.
ETHICS AND DISSEMINATION


The study has ethical approval from the Swedish Ethical Review Authority (2017/1135-31/3, 2019-03361) and the Norwegian Regional Ethical Committee (2015/889). The study is conducted according to good clinical practice and the Helsinki declaration. The results of the study will increase the knowledge about the mechanisms behind the effects of SSC for very preterm infants by dissemination to the scientific community through articles and at conferences, and to the society through parenting classes and magazines.
STUDY STATUS


Recruiting since April 2018. Expected trial termination June 2021.
TRIAL REGISTRATION NUMBER


NCT03521310 (ClinicalTrials.gov).",2020,"There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth.
","['very preterm infants cared for in skin-to-skin contact immediately after birth and potential physiological, epigenetic, psychological and neurodevelopmental consequences', '150 infants born at 28+0 to 32+6 gestational weeks']",['care immediately after birth in SSC with a parent or conventionally in an incubator'],"['autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health', 'cardiorespiratory stability according to the stability of the cardiorespiratory system in the preterm score']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.13168,"There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth.
","[{'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Linnér', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden agnes.linner@ki.se.""}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Westrup', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Lode-Kolz', 'Affiliation': 'Department of Paediatrics, Stavanger Universitetssjukehus, Stavanger, Norway.'}, {'ForeName': 'Stina', 'Initials': 'S', 'LastName': 'Klemming', 'Affiliation': 'Neonatal Unit, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Lillieskold', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Markhus Pike', 'Affiliation': 'Department of Paediatrics, Stavanger Universitetssjukehus, Stavanger, Norway.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Morgan', 'Affiliation': 'Global Risk Governance Programme, Law Faculty, University of Cape Town, Rondebosch, Western Cape, South Africa.'}, {'ForeName': 'Nils Johannes', 'Initials': 'NJ', 'LastName': 'Bergman', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}, {'ForeName': 'Siren', 'Initials': 'S', 'LastName': 'Rettedal', 'Affiliation': 'Department of Paediatrics, Stavanger Universitetssjukehus, Stavanger, Norway.'}, {'ForeName': 'Wibke', 'Initials': 'W', 'LastName': 'Jonas', 'Affiliation': ""Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.""}]",BMJ open,['10.1136/bmjopen-2020-038938']
1470,32636319,Serum Alpha-fetoprotein Levels and Clinical Outcomes in the Phase III CELESTIAL Study of Cabozantinib versus Placebo in Patients with Advanced Hepatocellular Carcinoma.,"PURPOSE


The phase III CELESTIAL study demonstrated improved overall survival (OS) and progression-free survival (PFS) with cabozantinib versus placebo in patients with previously treated, advanced hepatocellular carcinoma (HCC). We analyzed outcomes by baseline alpha-fetoprotein (AFP) and on-treatment AFP changes.
PATIENTS AND METHODS


Serum AFP was measured every 8 weeks by blinded, centralized testing. Outcomes were analyzed by baseline AFP bifurcated at 400 ng/mL and by on-treatment AFP response (≥20% decrease from baseline at Week 8). The optimal cutoff for change in AFP at Week 8 was evaluated using maximally selected rank statistics.
RESULTS


Median OS for cabozantinib versus placebo was 13.9 versus 10.3 months [HR, 0.81; 95% confidence interval (CI), 0.62-1.04] for patients with baseline AFP <400 ng/mL, and 8.5 versus 5.2 months (HR, 0.71; 95% CI, 0.54-0.94) for patients with baseline AFP ≥400 ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo. In the cabozantinib arm, median OS for patients with and without AFP response was 16.1 versus 9.1 months (HR, 0.61; 95% CI, 0.45-0.84). AFP response was independently associated with longer OS. The optimal cutoff for association with OS in the cabozantinib arm was ≤0% change in AFP at Week 8 [AFP control; HR 0.50 (95% CI, 0.35-0.71)]. HRs for PFS were consistent with those for OS.
CONCLUSIONS


Cabozantinib improved outcomes versus placebo across a range of baseline AFP levels. On-treatment AFP response and control rates were higher with cabozantinib than placebo, and were associated with longer OS and PFS with cabozantinib.",2020,ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo.,"['patients with previously treated, advanced hepatocellular carcinoma (HCC', '≥400', 'patients with advanced hepatocellular carcinoma']","['cabozantinib versus placebo', 'placebo']","['Median OS', 'median OS', 'AFP response rate', 'AFP response and control rates', 'AFP response', 'overall survival (OS) and progression-free survival (PFS', 'Serum alpha-fetoprotein levels and clinical outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1287375', 'cui_str': 'Serum alpha-fetoprotein level - finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.249652,ng/mL. Week 8 AFP response rate was 50% for cabozantinib versus 13% for placebo.,"[{'ForeName': 'Robin Kate', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California. katie.kelley@ucsf.edu.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital and UCL Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Groupement Hospitalier Lyon Nord, Lyon, France.'}, {'ForeName': 'Joong-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': 'Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': 'The Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Tam', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': ""Groupe Hospitalier L'Archet, Nice, France.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Dadduzio', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Markby', 'Affiliation': 'Exelixis, Inc., Alameda, California.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kaldate', 'Affiliation': 'Exelixis, Inc., Alameda, California.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3884']
1471,32638144,Impacts of a Home Visiting Program Enhanced with Content on Healthy Birth Spacing.,"OBJECTIVES


This study sought to determine the impact of Healthy Families Healthy Futures (HFHF) enhanced with Steps to Success (STS). HFHF is a structured home visiting program for teen parents in Houston that focuses on improving parenting skills and preventing child abuse. HFHF enhanced with STS includes content and activities aimed to reduce repeat pregnancies within 24 months after the first child's birth.
METHODS


The study team recruited 248 young mothers for the study, primarily through local health clinics and schools, and then randomly assigned them to either a treatment group that was eligible to participate in HFHF enhanced with STS or to a control group. The control group was not offered any other program through the study. Outcomes were measured by a survey administered 12 months after program intake, in five domains aligned with the program's logic model: (1) exposure to information related to program content, (2) contraception knowledge, (3) contraception use, (4) enhanced family functioning, and (5) child health and development. To estimate program impacts, we used ordinary least squares regression, controlling for demographics and baseline measures of the outcome variables, if available. We use both frequentist approaches (calculations of statistical significance) and Bayesian posterior probabilities to interpret the findings.
RESULTS


HFHF enhanced with STS significantly (p < .05) impacted exposure to information on parenting and birth control, with effects of 20.8 and 15.4 percentage points, respectively. Using Bayesian posterior probabilities, there is an 85% chance that the program had a favorable effect on these outcomes. We also calculate a probability of 77% that the program had a favorable impact on long-acting reversible contraceptive (LARC) use, but a probability of 89% that the program reduced knowledge of birth control pills; these two results were not statistically significant (p = .17 and .10, respectively).
CONCLUSIONS FOR PRACTICE


These findings are primarily favorable and consistent with the program content and goals. Smaller than anticipated sample sizes due to recruitment challenges increased the chances for random error to affect the ability to detect statistically significant differences on many of our other outcomes; Bayesian posterior probabilities can therefore aid in interpreting the impact estimates. More research of this promising model is warranted.",2020,"RESULTS


HFHF enhanced with STS significantly (p < .05) impacted exposure to information on parenting and birth control, with effects of 20.8 and 15.4 percentage points, respectively.","['248 young mothers for the study, primarily through local health clinics and schools', 'Healthy Families Healthy Futures (HFHF) enhanced with Steps to Success (STS']","['Home Visiting Program', 'HFHF', 'HFHF enhanced with STS or to a control group']","['parenting skills', 'knowledge of birth control pills', 'program content, (2) contraception knowledge, (3) contraception use, (4) enhanced family functioning, and (5) child health and development', 'Healthy Birth Spacing', 'long-acting reversible contraceptive (LARC']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",248.0,0.0298537,"RESULTS


HFHF enhanced with STS significantly (p < .05) impacted exposure to information on parenting and birth control, with effects of 20.8 and 15.4 percentage points, respectively.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zief', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA. szief@mathematica-mpr.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Deke', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burkander', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Langan', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}, {'ForeName': 'Subuhi', 'Initials': 'S', 'LastName': 'Asheer', 'Affiliation': 'Mathematica, P.O. Box 2393, Princeton, NJ, 08543, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02968-6']
1472,32640196,Impact of a Multimodal Telemonitoring Intervention on CPAP Adherence in Symptomatic OSA and Low Cardiovascular Risk: A Randomized Controlled Trial.,"BACKGROUND


One of the major challenges in treating OSA is to achieve adequate CPAP adherence. Telemonitoring has the potential to provide individualized management and early recognition of problems during treatment.
RESEARCH QUESTION


What is the effect of a multimodal telemonitoring intervention on treatment adherence, quality of life, and functional status in symptomatic patients with OSA and low cardiovascular risk?
STUDY DESIGN AND METHODS


In a multicenter, randomized controlled trial, patients newly diagnosed with OSA were randomly assigned to multimodal telemonitoring for 6 months vs usual care (UC). Telemonitoring consisted of built-in electronic alert algorithms for early adjustment of CPAP treatment in case of side effects, leaks, or persistent residual events. The primary outcome was CPAP adherence (in hours per night). Secondary outcomes included daily symptoms such as fatigue and sleepiness, and quality of life measured by using self-reported questionnaires.
RESULTS


A total of 206 patients with OSA and a median age of 50.6 years (interquartile range [IQR], 42.1; 58.1 years) were included in the study; they were predominantly male (63%) with a median BMI of 30.6 kg/m 2  (IQR, 26.8; 35.1 kg/m 2 ) and a median apnea-hypopnea index of 45.2 events/hour (IQR, 34.0; 60.0 events/hour). Of these, 102 received UC and 104 received telemonitoring. After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 ± 2.48 h per night in the telemonitoring group and 5.08 ± 2.44 h per night in the UC group; P = .30) or in percentage of patients adherent to treatment (> 4 h usage per night, > 70% nights; 64% in the telemonitoring group vs 72% in the UC group; P = .24). There was no significant difference between the groups in effect size of improvement in fatigue and sleepiness.
INTERPRETATION


In patients with severe OSA and low cardiovascular risk, multimodal telemonitoring did not increase CPAP adherence. For both the telemonitoring and UC groups, similar improvements in daytime symptoms were achieved.
TRIAL REGISTRY


ClinicalTrials.gov; No.: 01796769; URL: www.clinicaltrials.gov.",2020,"After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 ± 2.48 hours/night in the TM group and 5.08 ± 2.44 hours/night in the UC group, p = 0.30) or in % of patients adherent to treatment (over 4 hours usage/night, > 70% nights; 64% in TM versus 72% in UC, p = 0.24).","['obstructive sleep apnea (OSA', 'and Methods', '206 OSA patients aged 50.6 [42.1 ; 58.1] (median [IQR]) years; predominantly male (63%) with body mass index of 30.6 [26.8 ; 35.1] kg/m 2  and an apnea-hypopnea index of 45.2 [34.0 ; 60.0] events/hour) 102 received UC and 104 telemonitoring', 'newly diagnosed OSA patients', 'symptomatic OSA patients with low cardiovascular risk', 'symptomatic low-cardiovascular risk sleep apnea', 'severe OSA patients with low cardiovascular risk']","['NCT', 'multimodal telemonitoring for 6 months versus usual care (UC', 'multimodal telemonitoring intervention']","['treatment adherence, quality of life and functional status', 'daily symptoms such as fatigue and sleepiness, and quality of life measured by self-reported questionnaires', 'fatigue and sleepiness', 'daytime symptoms', 'mean duration of usage', 'CPAP adherence', 'CPAP adherence (in hours/night']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",,0.136478,"After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 ± 2.48 hours/night in the TM group and 5.08 ± 2.44 hours/night in the UC group, p = 0.30) or in % of patients adherent to treatment (over 4 hours usage/night, > 70% nights; 64% in TM versus 72% in UC, p = 0.24).","[{'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, Grenoble, France. Electronic address: rtamisier@chu-grenoble.fr.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Treptow', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, Grenoble, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Joyeux-Faure', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, Grenoble, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Levy', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, Grenoble, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sapene', 'Affiliation': 'Private practice sleep and respiratory disease center, Nouvelle Clinique Bel Air, Bordeaux, France.'}, {'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'Benmerad', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, Grenoble, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bailly', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, Grenoble, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Grillet', 'Affiliation': 'Private practice sleep and respiratory disease center, Valence, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Stach', 'Affiliation': 'Private practice sleep and respiratory disease center, Valenciennes, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Muir', 'Affiliation': 'Rouen University Hospital, Bois Guillaume, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Pegliasco', 'Affiliation': 'Private practice sleep and respiratory disease center, Marseille, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.05.613']
1473,32641330,Interventions with Music in PECTus excavatum treatment (IMPECT trial): a study protocol for a randomised controlled trial investigating the clinical effects of perioperative music interventions.,"INTRODUCTION


Pectus excavatum repair is associated with substantial postoperative pain, despite the use of epidural analgesia and other analgesic regimens. Perioperative recorded music interventions have been shown to alleviate pain and anxiety in adults, but evidence for children and adolescents is still lacking. This study protocol describes a randomised controlled trial that evaluates the effects of recorded music interventions on postoperative pain relief in children and adolescents after pectus excavatum repair.
METHODS


A multicentre randomised controlled trial was set up comparing the effects of perioperative recorded music interventions in addition to standard care with those of standard care only in patients undergoing a Nuss procedure for pectus excavatum repair. One hundred and seventy subjects (12-18 years of age) will be included in three centres in the Netherlands. Patient inclusion has started in November 2018, and is ongoing. The primary outcome is self-reported perceived pain measured on the visual analogue scale. Secondary outcomes are anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness.
ETHICS AND DISSEMINATION


This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.
TRIAL REGISTRATION NUMBER


NL6863.",2020,"The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol.","['children and adolescents after pectus excavatum repair', 'patients undergoing a Nuss procedure for pectus excavatum repair', 'One hundred and seventy subjects (12-18 years of age']","['perioperative recorded music interventions', 'recorded music interventions', 'Perioperative recorded music interventions', 'perioperative music interventions']","['postoperative pain relief', 'anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness', 'self-reported perceived pain measured on the visual analogue scale', 'pain and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016842', 'cui_str': 'Congenital pectus excavatum'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.200294,"The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol.","[{'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Billar', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands r.billar@erasmusmc.nl.""}, {'ForeName': 'A Y Rosalie', 'Initials': 'AYR', 'LastName': 'Kühlmann', 'Affiliation': 'Anaesthesiology, Saint Antonius Hospital, Nieuwegein, Utrecht, The Netherlands.'}, {'ForeName': 'J Marco', 'Initials': 'JM', 'LastName': 'Schnater', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vlot', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Jeremy J P', 'Initials': 'JJP', 'LastName': 'Tomas', 'Affiliation': ""Anaesthesiology, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Gerda W', 'Initials': 'GW', 'LastName': 'Zijp', 'Affiliation': ""Paediatric Surgery, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Rad', 'Affiliation': ""Anaesthesiology, Haga Hospital Juliana Children's Hospital, Den Haag, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Sjoerd A', 'Initials': 'SA', 'LastName': 'de Beer', 'Affiliation': ""Paediatric Surgery, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.""}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Stevens', 'Affiliation': ""Anaesthesiology, Emma Children's Hospital AMC, Amsterdam, North Holland, The Netherlands.""}, {'ForeName': 'Marten J', 'Initials': 'MJ', 'LastName': 'Poley', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'van Rosmalen', 'Affiliation': 'Biostatistics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Jeekel', 'Affiliation': 'Neuroscience, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Rene M H', 'Initials': 'RMH', 'LastName': 'Wijnen', 'Affiliation': ""Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Zuid-Holland, The Netherlands.""}]",BMJ open,['10.1136/bmjopen-2019-036380']
1474,32641332,"HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation.","INTRODUCTION


Tracheal intubation remains an everyday challenge for anaesthesiologists, even in patients without suspected difficult airways. The ideal positioning of the patient's head (flat, raised a few centimetres on a cushion in the sniffing position (SP), or raised to achieve horizontal alignment between the external acoustic meatus and the sternal angle) and the use of videolaryngoscopy remain controversial. This trial aims to compare the efficacy for orotracheal intubation of the SP or the head-elevated laryngoscopy position (HELP), which has been shown to improve laryngeal visualization and the intubation condition particularly in obese patients, in combination with a McGrath Mac videolaryngoscope whose video screen is either on or off (Video or NoVideo).
METHODS AND ANALYSIS


The HELP-VDL factorial trial is a prospective, randomised, parallel, multicentre, open study of 240 adult patients undergoing tracheal intubation under general anaesthesia. Patients will be allocated into four groups: SP-NoVideo, HELP-NoVideo, SP-Video and HELP-Video. The primary outcome is the proportion of orotracheal intubations that requires the assistance of a nurse anaesthetist. The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications. Data will be analysed on the intention-to-treat principle and a per-protocol basis.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethical Committee Ile de France V (Paris, France). Participant recruitment began on 3 July 2019. The results will be submitted for publication in peer-reviewed journals. Trial registration number NCT03987009; Pre-results.",2020,"The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications.","['240 adult patients undergoing tracheal intubation under general anaesthesia', 'obese patients', 'patient population without predictable difficulty of intubation', 'patients without suspected difficult airways']","['videolaryngoscope to facilitate orotracheal intubation', 'head-elevated laryngoscopy position', 'SP-NoVideo, HELP-NoVideo, SP-Video and HELP-Video', 'head-elevated laryngoscopy position (HELP', 'HELP-VDL']","['intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications', 'proportion of orotracheal intubations that requires the assistance of a nurse anaesthetist']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C2939167', 'cui_str': 'Intubation of esophagus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1504364', 'cui_str': 'Intubation complication'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]",240.0,0.101818,"The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications.","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anesthesiology, Hopital Foch, Suresnes, Île-de-France, France.'}, {'ForeName': 'Zoé', 'Initials': 'Z', 'LastName': 'Coppere', 'Affiliation': 'Department of Anaesthesiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, Île-de-France, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Dufour', 'Affiliation': 'Department of Anaesthesiology, Institut Mutualiste Montsouris, Paris, Île-de-France, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ouattara', 'Affiliation': 'Department of Anaesthesiology, Groupe hospitalier Paris Saint-Joseph, Paris, Île-de-France, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Trichereau', 'Affiliation': 'Research Unit, Hopital Foch, Suresnes, Île-de-France, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anesthesiology, Hopital Foch, Suresnes, Île-de-France, France m.fischler@orange.fr.'}]",BMJ open,['10.1136/bmjopen-2019-036570']
1475,32641334,Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation.,"INTRODUCTION


Primary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.
METHODS AND ANALYSIS


Mixed methods will be used: (1) design: intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.
ETHICS AND DISSEMINATION


Favourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.
TRIAL REGISTRATION NUMBER


NCT03353519; Pre-results.",2020,"After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT).",[],"[""intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life""]",[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",[],,0.13761,"After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT).","[{'ForeName': 'Maria Raisa Jessica Ryc', 'Initials': 'MRJR', 'LastName': 'Aquino', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK ra532@medschl.cam.ac.uk.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Mullis', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kreit', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Johnson', 'Affiliation': 'Leicester Diabetes Centre, University Hospital Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grant', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lim', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}]",BMJ open,['10.1136/bmjopen-2020-036879']
1476,32641335,"Integrated strategies to prevent intradialytic hypotension: research protocol of the DialHypot study, a prospective randomised clinical trial in hypotension-prone haemodialysis patients.","INTRODUCTION


In patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH) is a clinical problem that nephrologists and dialysis nurses face daily in their clinical routine. Despite the technological advances in the field of HD, the incidence of hypotensive events occurring during a standard dialytic treatment is still very high. Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term. Various strategies aimed at preventing IDH are currently available, but there is lack of conclusive data on more integrated approaches combining different interventions.
METHODS AND ANALYSIS


This is a prospective, randomised, open-label, crossover trial (each subject will be used as his/her own control) that will be performed in two distinct phases, each of which is divided into several subphases. In the first phase, 27 HD sessions for each patient will be used, and will be aimed at the validation of a new ultrafiltration (UF) profile, designed with an ascending/descending shape, and a standard dialysate sodium concentration. In the second phase, 33 HD sessions for each patient will be used and will be aimed at evaluating the combination of different UF and sodium profiling strategies through individualised dialysate sodium concentration.
ETHICS AND DISSEMINATION


The trial protocol has been reviewed and approved by the local Institutional Ethics Committee (Comitato Etico AVEN, prot. 43391 22.10.19). The results of the trial will be presented at local and international conferences and submitted for publication to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03949088).",2020,Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term.,"['patients on maintenance haemodialysis (HD), intradialytic hypotension (IDH', 'hypotension-prone haemodialysis patients']",[],"['severe immediate complications', 'mortality risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0388866,Frequently recurring hypotensive episodes during HD sessions expose patients not only to severe immediate complications but also to a higher mortality risk in the medium term.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Peyronel', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy francesco.peyronel@gmail.com.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Parenti', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Paride', 'Initials': 'P', 'LastName': 'Fenaroli', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Giuseppe Daniele', 'Initials': 'GD', 'LastName': 'Benigno', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Giovanni Maria', 'Initials': 'GM', 'LastName': 'Rossi', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Maggiore', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fiaccadori', 'Affiliation': 'Unità Operativa di Nefrologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-036893']
1477,32675553,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2020,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', 'FRS) Skills Curriculum', '12 international American College of Surgeons (ACS']","['Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'dV-Trainer', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.173584,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
1478,32673497,Dapagliflozin and Diuretic Use in Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF.,"BACKGROUND


In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), the sodium-glucose cotransporter 2 inhibitor dapagliflozin reduced the risk of worsening heart failure and death in patients with heart failure and reduced ejection fraction. We examined the efficacy and tolerability of dapagliflozin in relation to background diuretic treatment and change in diuretic therapy after randomization to dapagliflozin or placebo.
METHODS


We examined the effects of study treatment in the following subgroups: no diuretic and diuretic dose equivalent to furosemide <40, 40, and >40 mg daily at baseline. We examined the primary composite end point of cardiovascular death or a worsening heart failure event and its components, all-cause death and symptoms.
RESULTS


Of 4616 analyzable patients, 736 (15.9%) were on no diuretic, 1311 (28.4%) were on <40 mg, 1365 (29.6%) were on 40 mg, and 1204 (26.1%) were taking >40 mg. Compared with placebo, dapagliflozin reduced the risk of the primary end point across each of these subgroups: hazard ratios were 0.57 (95% CI, 0.36-0.92), 0.83 (95% CI, 0.63-1.10), 0.77 (95% CI, 0.60-0.99), and 0.78 (95% CI, 0.63-0.97), respectively ( P  for interaction=0.61). The hazard ratio in patients taking any diuretic was 0.78 (95% CI, 0.68-0.90). Improvements in symptoms and treatment toleration were consistent across the diuretic subgroups. Diuretic dose did not change in most patients during follow-up, and mean diuretic dose did not differ between the dapagliflozin and placebo groups after randomization.
CONCLUSIONS


The efficacy and safety of dapagliflozin were consistent across the diuretic subgroups examined in DAPA-HF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03036124.",2020,Diuretic dose did not change in most patients during follow-up and mean diuretic dose did not differ between the dapagliflozin and placebo group after randomization.  ,"['Patients with Heart Failure and Reduced Ejection Fraction in DAPA-HF', '4616 analyzable patients, 736 (15.9%) were on no diuretic, 1311 (28.4%) were on <40mg, 1365 (29.6%) on 40 mg and 1204 (26.1%) of patients were taking >40 mg', 'patients with heart failure and reduced ejection fraction']","['dapagliflozin or placebo', 'dapagliflozin', 'DAPA-HF', 'SGLT2 inhibitor dapagliflozin', 'Dapagliflozin and Diuretic', 'diuretic, diuretic dose equivalent to furosemide <40mg daily, 40mg daily and >40mg daily at baseline', 'placebo, dapagliflozin', 'dapagliflozin and placebo']","['cardiovascular (CV) death or a worsening HF event, its components, all-cause death and symptoms', 'Improvement in symptoms and treatment toleration', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",4616.0,0.120661,Diuretic dose did not change in most patients during follow-up and mean diuretic dose did not differ between the dapagliflozin and placebo group after randomization.  ,"[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Jackson', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis (I.S.A.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital and 1st Faculty of Medicine, Charles University, Prague, Czech Republic (J.B.).'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, The Netherlands (R.A.d.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg-Saar, Germany (M.B.).'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Quantitative Clinical Pharmacology, IMED Biotech Unit, Astra-Zeneca, Gaithersburg, MD (D.W.B.).'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Medanta, Gurgaon, India (V.K.C.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': '5th Department of Internal Medicine, Comenius University in Bratislava, Slovakia (A.D.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Cardiovascular, Renal and Metabolism Translational Medicines Unit, Early Clinical Development, IMED Biotech Unit (P.J.G.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Cumming School of Medicine and Libin Cardiovascular Institute, University of Calgary, AB, Canada (J.G.W.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (T.K.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City (M.N.K.).""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg, Sweden (C.E.A.L.).'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Argentina (F.A.M.).'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, QC, Canada (E.O.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia (S.T.).'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, ON, Canada (S.V.).""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047077']
1479,32681091,Exhausted T cell signature predicts immunotherapy response in ER-positive breast cancer.,"Responses to immunotherapy are uncommon in estrogen receptor (ER)-positive breast cancer and to date, lack predictive markers. This randomized phase II study defines safety and response rate of epigenetic priming in ER-positive breast cancer patients treated with checkpoint inhibitors as primary endpoints. Secondary and exploratory endpoints included PD-L1 modulation and T-cell immune-signatures. 34 patients received vorinostat, tamoxifen and pembrolizumab with no excessive toxicity after progression on a median of five prior metastatic regimens. Objective response was 4% and clinical benefit rate (CR + PR + SD > 6 m) was 19%. T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder. Tumor lymphocyte infiltration was 0.17%. Only two non-responders had PD-L1 expression >1%. This data defines a novel immune signature in PD-L1-negative ER-positive breast cancer patients who are more likely to benefit from immune-checkpoint and histone deacetylase inhibition (NCT02395627).",2020,"T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder.","['34 patients received', 'ER-positive breast cancer patients treated with', 'PD-L1-negative ER-positive breast cancer patients', 'ER-positive breast cancer']","['checkpoint inhibitors', 'vorinostat, tamoxifen and pembrolizumab']","['PD-L1 modulation and T-cell immune-signatures', 'clinical benefit rate', 'PD-L1 expression', 'Objective response', 'T-cell exhaustion (CD8 +\xa0 PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ', 'Tumor lymphocyte infiltration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]",34.0,0.0718826,"T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Terranova-Barberio', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Nela', 'Initials': 'N', 'LastName': 'Pawlowska', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Dhawan', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Moasser', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Melisko', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Rugo', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Roshun', 'Initials': 'R', 'LastName': 'Rahimi', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Deal', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Daud', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Rosenblum', 'Affiliation': 'Department of Dermatology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Munster', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA. pamela.munster@ucsf.edu.'}]",Nature communications,['10.1038/s41467-020-17414-y']
1480,32640755,A New Nasal Restriction Device Called FeelBreathe ®  Improves Breathing Patterns in Chronic Obstructive Pulmonary Disease Patients during Exercise.,"A device called FeelBreathe (FB) ®  was designed, developed, and patented for inspiratory muscle training. The main aim was to determine the acute responses on lung ventilation, gas exchange, and heart rate during exercise in patients with chronic obstructive pulmonary disease (COPD) with and without the use of FB. In this study, a randomized cross-over trial was performed with 18 men diagnosed with COPD (FEV 1  between 30% and 70% of its predicted value). Each participant randomly conducted two trials with 30 min of rest between them with the same protocol on a treadmill for 10 min at a constant rate of 50% of VO 2peak . Each test was performed randomly and in a crossover randomized design in two different conditions: (1) oronasal breathing; and (2) nasal breathing with FB (nasal ventilatory flow restriction device). It was observed that FB had positive effects on dynamic hyperinflation, breathing pattern, and breathing efficiency, with higher expiratory and inspiratory time. Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise. The results suggest that exercise performed with FB improved ventilatory responses compared to the oronasal mode in COPD patients. This new tool could be used during most daily tasks and exercise programs.",2020,"Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise.","['patients with chronic obstructive pulmonary disease (COPD) with and without the use of FB', '18 men diagnosed with COPD (FEV 1  between 30% and 70% of its predicted value', 'Chronic Obstructive Pulmonary Disease Patients during Exercise']","['Nasal Restriction Device Called FeelBreathe ®', 'oronasal breathing; and (2) nasal breathing with FB (nasal ventilatory flow restriction device']","['ventilatory responses', 'blood oxygen saturation percentage, oxygen uptake, and heart rate', 'acute responses on lung ventilation, gas exchange, and heart rate', 'dynamic hyperinflation, breathing pattern, and breathing efficiency, with higher expiratory and inspiratory time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0428686', 'cui_str': 'Inspiratory time'}]",,0.10336,"Despite these differences, blood oxygen saturation percentage, oxygen uptake, and heart rate showed a similar response for both conditions during exercise.","[{'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Gonzalez-Montesinos', 'Affiliation': 'Department of Physical Education, Faculty of Education Sciences, University of Cádiz, 11519 Cádiz, Spain.'}, {'ForeName': 'Aurelio', 'Initials': 'A', 'LastName': 'Arnedillo', 'Affiliation': 'University Hospital Puerta del Mar. Pneumology, Allergy and Thoracic Surgery Department, 11009 Cádiz, Spain.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Fernandez-Santos', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vaz-Pardal', 'Affiliation': 'Bahía Sur Andalusian Center for Sports Medicine, 11100 Cádiz, Spain.'}, {'ForeName': 'Pelayo A', 'Initials': 'PA', 'LastName': 'García', 'Affiliation': 'Center Sport Iberia, 29007 Málaga, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Castro-Piñero', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}, {'ForeName': 'Jesús G', 'Initials': 'JG', 'LastName': 'Ponce-González', 'Affiliation': 'Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, 11009 Cádiz, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134876']
1481,32641338,"'Only twice a year': a qualitative exploration of 6-month antiretroviral treatment refills in adherence clubs for people living with HIV in Khayelitsha, South Africa.","OBJECTIVE


Longer intervals between routine clinic visits and medication refills are part of patient-centred, differentiated service delivery (DSD). They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART). This qualitative study explored patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6 months in adherence clubs in Khayelitsha, South Africa.
DESIGN AND SETTING


In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants. All transcripts were audio-recorded, transcribed and translated to English, manually coded and thematically analysed. The participants had been involved in a randomised controlled trial evaluating multi-month ART dispensing in adherence clubs, comparing 6-month and 2-month refills.
PARTICIPANTS


Twenty-three patients, seven healthcare workers and six key informants.
RESULTS


Patients found that 6-month refills increased convenience and reduced unintended disclosure. Contrary to key informant concerns about patients' responsibility to manage larger quantities of ART, patients receiving 6-month refills were highly motivated and did not face challenges transporting, storing or adhering to treatment. All participant groups suggested that strict eligibility criteria were necessary for patients to realise the benefits of extended dispensing intervals. Six-month refills were felt to increase health system efficiency, but there were concerns about whether the existing drug supply system could adapt to 6-month refills on a larger scale.
CONCLUSIONS


Patients, healthcare workers and key informants found 6-month refills within adherence clubs acceptable and beneficial, but concerns were raised about the reliability of the supply chain to manage extended multi-month dispensing. Stepwise, slow expansion could avoid overstressing supply and allow time for the health system to adapt, permitting 6-month ART refills to enhance current DSD options to be more efficient and patient-centred within current health system constraints.",2020,They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART).,"['Twenty-three patients, seven healthcare workers and six key informants', 'people living with HIV in Khayelitsha, South Africa', 'patient, healthcare worker and key informant experiences and perceptions of extending ART refills to 6\u2009months in adherence clubs in Khayelitsha, South Africa', 'In-depth interviews were conducted in isiXhosa with purposively selected patients and in English with healthcare workers and key informants']",[],"['unintended disclosure', 'health system efficiency']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376245', 'cui_str': 'English language'}]",[],"[{'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",23.0,0.048509,They have been shown to improve patient outcomes as well as optimise health services-vital as 'universal test-and-treat' targets increase numbers of HIV patients on antiretroviral treatment (ART).,"[{'ForeName': 'Claire Marriott', 'Initials': 'CM', 'LastName': 'Keene', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa clairekeene@gmail.com.'}, {'ForeName': 'Nompumelelo', 'Initials': 'N', 'LastName': 'Zokufa', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Emilie C', 'Initials': 'EC', 'LastName': 'Venables', 'Affiliation': 'Southern Africa Medical Unit, Medecins Sans Frontieres South Africa, Cape Town, South Africa.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Wilkinson', 'Affiliation': 'International AIDS Society, Cape Town, South Africa.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Disease, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cassidy', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Snyman', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Grimsrud', 'Affiliation': 'International AIDS Society, Cape Town, South Africa.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Voget', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'von der Heyden', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Siphokazi', 'Initials': 'S', 'LastName': 'Zide-Ndzungu', 'Affiliation': 'Western Cape Department of Health, Cape Town, South Africa.'}, {'ForeName': 'Vinayak', 'Initials': 'V', 'LastName': 'Bhardwaj', 'Affiliation': 'Médecins Sans Frontières South Africa, Cape Town, South Africa.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Isaakidis', 'Affiliation': 'Southern Africa Medical Unit, Medecins Sans Frontieres South Africa, Cape Town, South Africa.'}]",BMJ open,['10.1136/bmjopen-2020-037545']
1482,32641337,FitSkills: protocol for a stepped wedge cluster randomised trial of a community-based exercise programme to increase participation among young people with disability.,"INTRODUCTION


There is a need to develop relevant, acceptable initiatives that facilitate physical activity participation in young people with disability.  FitSkills  was developed to support young people with disability to exercise. The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability. The secondary aims are to evaluate cost-effectiveness, changes in attitudes towards disability and other health-related outcomes for young people with disability.
METHODS AND ANALYSIS


A stepped wedge cluster randomised trial using a cohort design and embedded health economic evaluation will compare the effect of  FitSkills  with a control phase.  FitSkills  matches a young person with disability with a student mentor and the pair exercise together at their local gymnasium for 1 hour, two times per week for 12 weeks (24 sessions in total). One hundred and sixty young people with disability aged 13 to 30 years will be recruited. Eight community gymnasia will be recruited and randomised into four cluster units to have  FitSkills  introduced at 3-month intervals. Primary (feasibility, participation and health-related quality of life) and secondary outcomes will be collected longitudinally every 3 months from trial commencement, with eight data collection time points in total. The Practical Robust Implementation and Sustainability Model will be used to support knowledge translation and implementation of project findings into policy and practice.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the La Trobe University Human Ethics Committee (HEC17-012), Australian Catholic University (2017-63R), Deakin University (2017-206) and the Victorian Department of Education and Training (2018_003616). Results will be disseminated through published manuscripts, conference presentations, public seminars and practical resources for stakeholder groups.
TRIAL REGISTRATION NUMBER


ACTRN12617000766314.
TRIAL SPONSOR


La Trobe University.",2020,"The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability.","['Eight community gymnasia', 'One hundred and sixty young people with disability aged 13 to 30 years', 'young people with disability']",['community-based exercise programme'],"['Primary (feasibility, participation and health-related quality of life']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",160.0,0.131616,"The primary aims are to investigate if  FitSkills  can be scaled up from a small, university-led programme to run as a larger community-university partnership programme, and to determine its effectiveness in improving physical activity participation and health-related quality of life for young people with disability.","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia n.shields@latrobe.edu.au.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Willis', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Imms', 'Affiliation': 'Centre for Disability and Development Research, Australian Catholic University, Melbourne, VIC, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Prendergast', 'Affiliation': 'Department of Mathematics and Statistics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Watts', 'Affiliation': 'School of Health and Social Development, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'van Dorsselaer', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'McKenzie', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Bruder', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037153']
1483,32641340,Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial.,"INTRODUCTION


Sepsis is defined as detrimental immune response to an infection. This overwhelming reaction often abolishes a normal reconstitution of the immune cell homeostasis that in turn increases the risk for further complications. Recent studies revealed a favourable impact of ketone bodies on resolution of inflammation. Thus, a ketogenic diet may provide an easy-to-apply and cost-effective treatment option potentially alleviating sepsis-evoked harm. This study is designed to assess the feasibility, efficiency and safety of a ketogenic diet in septic patients.
METHODS AND ANALYSIS


This monocentric study is a randomised, controlled and open-label trial, which is conducted on an intensive care unit of a German university hospital. As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied. The primary endpoint is the detection of ketone bodies in patients' blood and urine samples. As secondary endpoints, the impact on important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality) and the effect on the immune system are analysed.
ETHICS AND DISSEMINATION


The study has received the following approvals: Ethics Committee of the Medical Faculty of Ruhr-University Bochum (No. 18-6557-BR). Results will be made available to critical care survivors, their caregivers, the funders, the critical care societies and other researchers by publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS


German Clinical Trial Register (DRKS00017710); Universal Trial Number (U1111-1237-2493).",2020,As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied.,"['septic patients', 'intensive care unit of a German university hospital', 'septic patients on ICU']","['intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control', 'carbohydrate-reduced nutrition', 'ketogenic diet']","['important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality', 'feasibility, efficiency and safety', ""detection of ketone bodies in patients' blood and urine samples""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",,0.164771,As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rahmel', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany tim.rahmel@ruhr-uni-bochum.de.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Hübner', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Koos', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Katrin-Maria', 'Initials': 'KM', 'LastName': 'Willemsen', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Strauß', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Effinger', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Adamzik', 'Affiliation': 'Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kreth', 'Affiliation': 'Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-038532']
1484,32641367,Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND).,"INTRODUCTION


The BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.
METHODS AND ANALYSIS


The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring  > 16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.
ETHICS AND DISSEMINATION


Ethical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.
TRIAL REGISTRATION NUMBER


ISRCTN19674644.",2020,The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance.,"['treatment-resistant moderate to severe depression', '368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring  > 16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK', 'adults with moderate to severe treatment resistant depression']","['connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS', '20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance', 'Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation']","['HDRS-17 score', 'depression response', 'assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life', 'Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",368.0,0.369587,The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance.,"[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morriss', 'Affiliation': 'Psychiatry, University of Nottingham, Nottingham, UK richard.morriss@nottingham.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelghani', 'Affiliation': 'Camden and Islington NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Dorothee P', 'Initials': 'DP', 'LastName': 'Auer', 'Affiliation': 'Arthritis Research UK Pain Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'University of Leicester, Leicester, Leicestershire, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bates', 'Affiliation': 'Nottingham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blamire', 'Affiliation': 'University of Newcastle upon Tyne, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Briley', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Brookes', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Sarina', 'Initials': 'S', 'LastName': 'Iwabuchi', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'School of Medicine, University of Nottingham, nottingham, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kaylor-Hughes', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Lankappa', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Liddle', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McAllister-Williams', 'Affiliation': 'University of Newcastle upon Tyne, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': ""O'Neill-Kerr"", 'Affiliation': 'Northamptonshire Healthcare NHS Foundation Trust, Kettering, Northamptonshire, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pszczolkowski Parraguez', 'Affiliation': 'Precision Imaging Beacon, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Suazo Di Paola', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Psychiatry, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Walters', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038430']
1485,32645095,The effects of static stretching programs on muscle strength and muscle architecture of the medial gastrocnemius.,"INTRODUCTION


Static stretching (SS) program are widely used in clinical and athletic settings. Many previous studies investigate the effect of SS program on muscle strength and muscle architecture (muscle thickness, and pennation angleh). However, no consensus has been reached about the effect of SS programs on muscle strength and muscle architecture. The aim of this study was to investigate the effects of 6-week SS programs performed at different weekly frequencies on muscle strength, muscle thickness and pennation angle at different ankle joint positions.
METHODS


A total of 24 healthy male volunteers were performed 6-week SS programs (2,160 s of SS: 360 s/week*6 weeks) and were randomized to a group that performed SS once a week, or a group that performed SS three times per week. Total time under stretching was equated between groups. The muscle strength (maximum voluntary isometric contraction) at three different ankle joints were assessed before and after the 6-week SS program. In addition, muscle thickness and pennation angle were assessed by ultrasonography before and after 6-week SS program.
RESULTS


There were no significant changes in all variables before and after the 6-week SS program, regardless of weekly frequency (p > 0.05).
CONCLUSIONS


Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.",2020,"Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.",['24 healthy male volunteers'],"['Static stretching (SS) program', 'static stretching programs', 'SS program', 'SS programs']","['muscle strength (maximum voluntary isometric contraction', 'Total time under stretching', 'muscle strength and muscle architecture of the medial gastrocnemius', 'muscle strength, muscle thickness and pennation angle', 'muscle strength or muscle architecture', 'muscle strength and muscle architecture (muscle thickness, and pennation angleh']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",24.0,0.0105047,"Our results suggest that 6-week SS programs do not increase muscle strength or muscle architecture at different ankle joint positions, regardless of stretching frequency; however, no negative effect on these outcomes was observed, contrary to evidence on the immediate, detrimental effects of SS.","[{'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Kakeru', 'Initials': 'K', 'LastName': 'Hiraizumi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kiyono', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Taizan', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Nishishita', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata City, Japan.'}]",PloS one,['10.1371/journal.pone.0235679']
1486,32645109,"A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan.","BACKGROUND


Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
METHODS AND FINDINGS


A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints.
CONCLUSIONS


Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230).
TRIAL REGISTRATION


The trial is registered at ISRCTN, trial number ISRCTN30393230.",2020,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","['children aged 6-59 months', 'in Kenya and South Sudan', 'acute malnutrition in children 6-59 months (ComPAS trial', 'From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male', 'Kenya and South Sudan']","['combined protocol against standard care', 'SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF']","['cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains', 'nutritional recovery']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C3273373', 'cui_str': 'South Sudan'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517590', 'cui_str': '16.7'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}]",2071.0,0.180003,"Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.
","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Opondo', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lelijveld', 'Affiliation': 'No Wasted Lives, Action Against Hunger UK, London, United Kingdom.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Marron', 'Affiliation': 'International Rescue Committee, New York, New York, United States of America.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Onyo', 'Affiliation': 'Action Against Hunger, Juba, South Sudan.'}, {'ForeName': 'Eunice N', 'Initials': 'EN', 'LastName': 'Musyoki', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Adongo', 'Affiliation': 'International Rescue Committee, Nairobi, Kenya.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University School of Medicine, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Briend', 'Affiliation': 'Department of International Health, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Kerac', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003192']
1487,32646037,Crying Therapy Intervention for Breast Cancer Survivors: Development and Effects.,"BACKGROUND


crying therapy is currently being applied in some countries to treat cancer patients, manage pain, and promote mental health. However, little nursing and medical research on the effects of crying therapy has been conducted in other parts of the world. This study aimed to develop a crying therapy program for breast cancer survivors and assess its effects. Interventions/method: data from 27 breast cancer survivors in South Korea were analyzed. The intervention, employing a single group, pre-post-test quasi-experimental design, was divided into three phases, and effects were verified for emotional (distress, fatigue, and mood conditions) and physiological (cortisol, immunoglobulin G, and blood pressure) variables.
RESULTS


there were significant changes in distress, mood changes, and immunoglobulin G and smaller changes in blood pressure postintervention. Fatigue and cortisol showed no significant changes.
CONCLUSIONS


this study demonstrated the effectiveness of a short-term crying therapy program that can induce positive emotional changes and physiological effects in breast cancer survivors. This intervention can improve quality of life, indicating its value as a self-care program for cancer survivors.",2020,"Fatigue and cortisol showed no significant changes.
","['Breast Cancer Survivors', 'breast cancer survivors', 'cancer survivors', '27 breast cancer survivors in South Korea']","['short-term crying therapy program', 'Crying Therapy Intervention', 'crying therapy program']","['quality of life', 'Fatigue and cortisol', 'distress, mood changes, and immunoglobulin G and smaller changes in blood pressure postintervention', 'positive emotional changes and physiological effects', 'emotional (distress, fatigue, and mood conditions) and physiological (cortisol, immunoglobulin G, and blood pressure) variables']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",27.0,0.0200838,"Fatigue and cortisol showed no significant changes.
","[{'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Byun', 'Affiliation': 'School of Nursing, Yeungnam University College, Daegu 42415, Korea.'}, {'ForeName': 'Hyenam', 'Initials': 'H', 'LastName': 'Hwang', 'Affiliation': 'Department of Nursing, Daegu University, Daegu 42400, Korea.'}, {'ForeName': 'Gyung-Duck', 'Initials': 'GD', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Dongyang University, Kyungpook 36040, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17134911']
1488,32651046,Corrigendum to 'Dynamic risk assessment based on positron emission tomography scanning in diffuse large B-cell lymphoma: Post-hoc analysis from the PETAL trial' [Eur J Canc 124 (January 2020) 25-36].,,2020,,['diffuse large B-cell lymphoma'],"[""Corrigendum to 'Dynamic risk assessment based on positron emission tomography scanning""]",[],"[{'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",[],,0.0252584,,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Electronic address: christine.schmitz@uk-essen.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Müller', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Hanoun', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Boellaard', 'Affiliation': 'Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Brinkmann', 'Affiliation': 'Center for Clinical Trials, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Jöckel', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Department of Hematology, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rekowski', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.019']
1489,32653082,Brainwave entrainment to minimise sedative drug doses in paediatric surgery: a randomised controlled trial.,"BACKGROUND


Anaesthetic drugs may cause neuroapoptosis in children and are routinely used off-label in specific age groups. Techniques that reduce anaesthetic drug dose requirements in children may thus enhance the safety of paediatric sedation or anaesthesia. Brainwave entrainment, notably in the form of auditory binaural beats, has been shown to have sedative effects in adults. We evaluated the influence of brainwave entrainment on propofol dose requirements for sedation in children.
METHODS


We randomised 49 boys scheduled for sub-umbilical surgery under caudal blockade to an entrainment or a control group. Small differences in pitch were applied to each ear to create binaural beats, supplemented by synchronous visual stimuli, within the electroencephalographic frequency bands seen during relaxation and (rapid eye movement/non-rapid eye movement) sleep. After establishment of caudal block, propofol infusion was started at 5 mg kg -1  h -1 . Intraoperatively, the infusion rate was adjusted every 5 min depending on the sedation state judged by the bispectral index (BIS). The infusion rate was decreased by 1 mg kg -1  h -1  if BIS was <70, and was increased if BIS was >70, heart rate increased by 20%, or if there were other signs of inadequate sedation.
RESULTS


Mean propofol infusion rates were 3.0 (95% confidence interval [CI]: 2.4-3.6) mg kg -1  h -1 vs 4.2 (95% CI: 3.6-4.8) mg kg -1  h -1  in the entrainment and control groups, respectively (P<0.01). BIS values were similar in the two groups.
CONCLUSIONS


Brainwave entrainment effectively reduced the propofol infusion rates required for sedation in children undergoing surgery with regional anaesthesia. Further studies are needed to investigate the possibility of phasing out propofol infusions completely during longer surgical procedures and optimising the settings of brainwave stimulation.
CLINICAL TRIAL REGISTRATION


DRKS00005064.",2020,"BIS values were similar in the two groups.
","['paediatric surgery', 'children undergoing surgery with regional anaesthesia', '49 boys scheduled for sub-umbilical surgery under caudal blockade to an entrainment or a control group', 'children']","['propofol infusion', 'propofol']","['Mean propofol infusion rates', 'propofol infusion rates', 'heart rate', 'BIS values', 'infusion rate']","[{'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",49.0,0.19391,"BIS values were similar in the two groups.
","[{'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmid', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: peter.marhofer@meduniwien.ac.at.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Opfermann', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zadrazil', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kimberger', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Triffterer', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Klug', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.050']
1490,32654156,Neuropathy symptom and change: Inotersen treatment of hereditary transthyretin amyloidosis.,"INTRODUCTION


Hereditary transthyretin-mediated amyloidosis (hATTR) manifests as multisystem dysfunction, including progressive polyneuropathy. Inotersen, an antisense oligonucleotide, improved the course of neuropathic impairment in patients with hATTR in the pivotal NEURO-TTR study (NCT01737398). To determine inotersen's impact on symptoms and patients' neuropathy experience, we performed a post hoc analysis of the Neuropathy Symptoms and Change (NSC) score.
METHODS


Stage 1 or 2 hATTR patients were randomized to receive weekly subcutaneous inotersen or placebo for 65 weeks. NSC score was assessed at baseline and 35 and 66 weeks.
RESULTS


At 66 weeks, inotersen-treated patients had symptom stabilization as compared with worsening in patients receiving placebo, based on total NSC score. There were also improvements in the subdomains of muscle weakness, sensory, pain, and autonomic symptoms, and for various individual items.
DISCUSSION


Inotersen treatment stabilized neuropathy symptoms, including autonomic symptoms, in patients with hATTR according to NSC score. Thus, the NSC may be an effective measure to assess neuropathy progression and patients' neuropathy experience in clinical practice.",2020,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","['patients with hATTR based on the NSC score', 'Stage 1/2 hATTR patients', 'Hereditary Transthyretin Amyloidosis']","['subcutaneous inotersen or placebo', 'placebo']","['NSC score', 'Neuropathy Symptoms and Change (NSC) score', 'muscle weakness, sensory, pain, and autonomic symptoms', 'neuropathic impairment', 'Neuropathy Symptom and Change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0554384,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Department of Neurosciences, Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'Department of Neurology, Federal University of Rio de Janeiro, University Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Department of Peripheral Neuropathy, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Khella', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Department of Medicine, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc, San Diego, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27023']
1491,32654212,mNIS+7 and lower limb function in inotersen treatment of hereditary transthyretin-mediated amyloidosis.,"INTRODUCTION


Inotersen, an antisense oligonucleotide inhibitor of transthyretin (TTR) protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score (NIS) +7 neurophysiologic tests (mNIS+7) in patients with hereditary TTR-mediated amyloidosis (hATTR) with polyneuropathy. This analysis assessed the mNIS+7 components by anatomic location and the lower limb function (LLF) test.
METHODS


Adults with hATTR in the NEURO-TTR trial (NCT01737398) were randomly assigned to receive weekly doses of subcutaneous inotersen 300 mg or placebo for 65 weeks. The mNIS+7 and LLF were assessed at 35 and 66 weeks.
RESULTS


All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation) and the LLF showed significant efficacy in patients receiving inotersen versus placebo; however, NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate during deep breathing did not show significant effects.
DISCUSSION


The results of this analysis reinforce the beneficial effect of inotersen on slowing neuropathy progression in patients with hATTR polyneuropathy.",2020,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","['Adults with hATTR', 'patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy', 'patients with hATTR polyneuropathy']","['subcutaneous inotersen 300 mg or placebo', 'placebo']","['All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation', 'mNIS+7 and LLF', 'Mnis+7 And Lower Limb Function', 'NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate deep breathing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0206247', 'cui_str': 'Polyneuropathy in amyloidosis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1504824', 'cui_str': 'SLC5A5 protein, human'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}]",,0.124471,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc., San Diego, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27022']
1492,32665344,Study protocol of the Health4Life initiative: a cluster randomised controlled trial of an eHealth school-based program targeting multiple lifestyle risk behaviours among young Australians.,"INTRODUCTION


Lifestyle risk behaviours, including alcohol use, smoking, poor diet, physical inactivity, poor sleep (duration and/or quality) and sedentary recreational screen time ('the Big 6'), are strong determinants of chronic disease. These behaviours often emerge during adolescence and co-occur. School-based interventions have the potential to address risk factors prior to the onset of disease, yet few eHealth school-based interventions target multiple behaviours concurrently. This paper describes the protocol of the  Health4Life Initiative , an eHealth school-based intervention that concurrently addresses the Big 6 risk behaviours among secondary school students.
METHODS AND ANALYSIS


A multisite cluster randomised controlled trial will be conducted among year 7 students (11-13 years old) from 72 Australian schools. Stratified block randomisation will be used to assign schools to either the  Health4Life  intervention or an active control (health education as usual).  Health4Life  consists of (1) six web-based cartoon modules and accompanying activities delivered during health education (once per week for 6 weeks), and a smartphone application (universal prevention), and (2) additional app content, for students engaging in two or more risk behaviours when they are in years 8 and 9 (selective prevention). Students will complete online self-report questionnaires at baseline, post intervention, and 12, 24 and 36 months after baseline. Primary outcomes are consumption of sugar-sweetened beverages, moderate-to-vigorous physical activity, sleep duration, sedentary recreational screen time and uptake of alcohol and tobacco use.
ETHICS AND DISSEMINATION


This study has been approved by the University of Sydney (2018/882), NSW Department of Education (SERAP no. 2019006), University of Queensland (2019000037), Curtin University (HRE2019-0083) and relevant Catholic school committees. Results will be presented to schools and findings disseminated via peer-reviewed journals and scientific conferences. This will be the first evaluation of an eHealth intervention, spanning both universal and selective prevention, to simultaneously target six key lifestyle risk factors among adolescents.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12619000431123), 18 March 2019.",2020,"Students will complete online self-report questionnaires at baseline, post intervention, and 12, 24 and 36 months after baseline.","['2019006), University of Queensland (2019000037), Curtin University (HRE2019-0083) and relevant Catholic school committees', 'year 7 students (11-13\u2009years old) from 72 Australian schools', 'University of Sydney (2018/882), NSW Department of Education (SERAP no', 'secondary school students', 'young Australians']","['eHealth school-based program targeting multiple lifestyle risk behaviours', 'Health4Life  consists of (1) six web-based cartoon modules and accompanying activities delivered during health education', 'Health4Life  intervention or an active control (health education as usual']","['consumption of sugar-sweetened beverages, moderate-to-vigorous physical activity, sleep duration, sedentary recreational screen time and uptake of alcohol and tobacco use']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholic, follower of religion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}]",,0.051763,"Students will complete online self-report questionnaires at baseline, post intervention, and 12, 24 and 36 months after baseline.","[{'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia katrina.champion@sydney.edu.au.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Newton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Kay-Lambkin', 'Affiliation': 'Priority Research Centre for Brain and Mental Health, The University of Newcastle Faculty of Health and Medicine, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Thornton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Slade', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sunderland', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Gardner', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Parmenter', 'Affiliation': 'Department of Exercise Physiology, University of NSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'School of Education, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Nyanda', 'Initials': 'N', 'LastName': 'McBride', 'Affiliation': 'National Drug Research Institute, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Allsop', 'Affiliation': 'National Drug Research Institute, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Spring', 'Affiliation': 'Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Scarlett', 'Initials': 'S', 'LastName': 'Smout', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bridie', 'Initials': 'B', 'LastName': 'Osman', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035662']
1493,32665372,Transmitted Home Oximetry and Duration of Home Oxygen in Premature Infants.,"OBJECTIVES


To determine if a home oxygen therapy (HOT) management strategy that includes analysis of recorded home oximetry (RHO) data, compared with standard monthly clinic visit assessments, reduces duration of HOT without harm in premature infants.
METHODS


The RHO trial was an unmasked randomized clinical trial conducted in 9 US medical centers from November 2013 to December 2017, with follow-up to February 2019. Preterm infants with birth gestation ≤37 + 0/7 weeks, discharged on HOT, and attending their first pulmonary visit were enrolled. The intervention was an analysis of transmitted RHO between clinic visits ( n  = 97); the standard-care group received monthly clinic visits with in-clinic weaning attempts ( n  = 99). The primary outcomes were the duration of HOT and parent-reported quality of life. There were 2 prespecified secondary safety outcomes: change in weight and adverse events within 6 months of HOT discontinuation.
RESULTS


Among 196 randomly assigned infants (mean birth gestational age: 26.9 weeks; SD: 2.6 weeks; 37.8% female), 166 (84.7%) completed the trial. In the RHO group, the mean time to discontinue HOT was 78.1 days (SE: 6.4), compared with 100.1 days (SE: 8.0) in the standard-care group ( P  = .03). The quality-of-life scores improved from baseline to 3 months after discontinuation of HOT in both groups ( P  = .002), but the degree of improvement did not differ significantly between groups ( P  = .75).
CONCLUSIONS


RHO was effective in reducing the duration of HOT in premature infants. Parent quality of life improved after discontinuation. RHO allows physicians to determine which infants can be weaned and which need prolonged oxygen therapy between monthly visits.",2020,"The quality-of-life scores improved from baseline to 3 months after discontinuation of HOT in both groups ( P  = .002), but the degree of improvement did not differ significantly between groups ( P  = .75).
","['Preterm infants with birth gestation ≤37 + 0/7 weeks, discharged on HOT, and attending their first pulmonary visit were enrolled', '9 US medical centers from November 2013 to December 2017, with follow-up to February 2019', 'premature infants', 'Premature Infants', '196 randomly assigned infants (mean birth gestational age: 26.9 weeks; SD: 2.6 weeks; 37.8% female), 166 (84.7%) completed the trial']","['home oxygen therapy (HOT', 'standard-care group received monthly clinic visits with in-clinic weaning attempts']","['weight and adverse events', 'duration of HOT and parent-reported quality of life', 'quality-of-life scores', 'mean time to discontinue HOT', 'duration of HOT', 'Parent quality of life']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.10675,"The quality-of-life scores improved from baseline to 3 months after discontinuation of HOT in both groups ( P  = .002), but the degree of improvement did not differ significantly between groups ( P  = .75).
","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Rhein', 'Affiliation': 'Divisions of Neonatology and lawrence.rhein@umassmemorial.org.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'White', 'Affiliation': 'Divisions of Neonatology and.'}, {'ForeName': 'Tregony', 'Initials': 'T', 'LastName': 'Simoneau', 'Affiliation': ""Division of Pediatric Pulmonology, School of Medicine, University of Connecticut and Connecticut Children's Medical Center, Hartford, Connecticut.""}, {'ForeName': 'Nadav', 'Initials': 'N', 'LastName': 'Traeger', 'Affiliation': ""Division of Pediatric Pulmonology, Maria Fareri Children's Hospital, Valhalla, New York.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lahiri', 'Affiliation': 'Division of Pediatric Pulmonology, Larner College of Medicine, The University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Kremer', 'Affiliation': 'Pediatric Pulmonology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sheils', 'Affiliation': ""Department of Medicine, Harvard Medical School, Harvard University and Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Meyer', 'Affiliation': 'Division of Neonatology, Baystate Health Center, Springfield, Massachusetts.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Rosenkrantz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Connecticut Health, Farmington, Connecticut.'}, {'ForeName': 'Sankaran', 'Initials': 'S', 'LastName': 'Krishnan', 'Affiliation': ""Division of Pediatric Pulmonology, Maria Fareri Children's Hospital, Valhalla, New York.""}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Hartman', 'Affiliation': 'Division of Neonatology, Geisel School of Medicine, Dartmouth College, Manchester, New Hampshire.'}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts; and.""}, {'ForeName': 'Elie G', 'Initials': 'EG', 'LastName': 'Abu Jawdeh', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, College of Medicine, University of Kentucky, Lexington, Kentucky.'}]",Pediatrics,['10.1542/peds.2020-0079']
1494,32665381,"Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials.","INTRODUCTION


Left-sided infective endocarditis (IE) is a serious infection with a heavy burden for patients and healthcare system. Oral switch after initial intravenous antibiotic therapy may reduce costs and improve patients' discomfort without increasing unfavourable outcomes. We describe the methodology of two simultaneously conducted open-label randomised trials aiming to assess non-inferiority of oral switch as compared with entirely intravenous antibiotic therapy for the treatment of left-sided IE.
METHODS AND ANALYSIS


Two simultaneous multicentre open-label prospective randomised trials assessing non-inferiority of oral switch during antibiotic treatment as compared with entirely intravenous therapy in patients with left-sided IE are ongoing. One trial is dedicated to left-sided IE caused by multisusceptible staphylococci (Relais Oral Dans le traitement des Endocardites à staphylocoques ou streptOcoques (RODEO)-1) and the other is dedicated to left-sided IE caused by susceptible streptococci or enterococci (RODEO-2). It is planned to randomise 324 patients in each trial after an initial course of at least 10 days of intravenous antibiotic therapy either to continue intravenous antibiotic therapy or to switch to oral antibiotic therapy. The primary outcome is treatment failure within 3 months after the end of antibiotic treatment, a composite outcome defined by all-cause death and/or symptomatic embolic events and/or unplanned valvular surgery and/or microbiological relapse (with the primary pathogen). Secondary outcomes include patient quality of life, echocardiographic outcome, costs and efficiency associated with IE care. Statistical analysis will be performed with a non-inferiority margin of 10% and a one-sided 2.5% type I error.
ETHICS AND DISSEMINATION


Written informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS-Region Centre-Ouest 1, 2015-R26, 23 February 2016). Study findings will be published in peer-reviewed journals and disseminated through presentation at relevant national and international conferences.
TRIAL REGISTRATION NUMBER


EudraCT Number: 2015-002371-16 and NCT02701608; NCT02701595.",2020,"METHODS AND ANALYSIS


Two simultaneous multicentre open-label prospective randomised trials assessing non-inferiority of oral switch during antibiotic treatment as compared with entirely intravenous therapy in patients with left-sided IE are ongoing.",['patients with left-sided IE are ongoing'],"['intravenous antibiotic therapy', 'Oral switch versus standard intravenous antibiotic therapy', 'entirely intravenous antibiotic therapy', 'oral switch during antibiotic treatment']","['treatment failure within 3 months after the end of antibiotic treatment, a composite outcome defined by all-cause death and/or symptomatic embolic events and/or unplanned valvular surgery and/or microbiological relapse (with the primary pathogen', 'patient quality of life, echocardiographic outcome, costs and efficiency associated with IE care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1827151', 'cui_str': 'Left sided infective endocarditis'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0559680', 'cui_str': 'Intravenous antibiotic therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}]",,0.161677,"METHODS AND ANALYSIS


Two simultaneous multicentre open-label prospective randomised trials assessing non-inferiority of oral switch during antibiotic treatment as compared with entirely intravenous therapy in patients with left-sided IE are ongoing.","[{'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lemaignen', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, Centre Hospitalier Régional Universitaire de Tours, Tours, France louis.bernard@univ-tours.fr.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Tattevin', 'Affiliation': 'Service de Maladies Infectieuses et de Réanimation Médicale, Centre Hospitalier Universitaire de Rennes, Rennes, Bretagne, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bru', 'Affiliation': ""Service d'infectiologie et de médecine interne, Centre Hospitalier Annecy-Genevois, Epagny Metz-Tessy, Rhône-Alpes, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Duval', 'Affiliation': 'INSERM Clinical Investigation Center 1425, IAME 1138, Universite Paris Diderot, Sorbonne Paris-Cité, Paris, Île-de-France, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Hoen', 'Affiliation': 'Service de Maladies Infectieuses et Tropicales, CHRU de Nancy, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Brunet-Houdard', 'Affiliation': ""Unité d'Evaluation Médico-Economique, EA7505, Education Ethique, Santé, Centre Hospitalier Régional Universitaire de Tours, Université de Tours, Tours, Centre, France.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Mainardi', 'Affiliation': 'Service de Microbiologie, APHP, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': ""Unité d'Evaluation Médico-Economique, EA7505, Education Ethique, Santé, Centre Hospitalier Régional Universitaire de Tours, Université de Tours, Tours, Centre, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033540']
1495,32645813,"Corrections to ""Phase III trial of concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy for limited-disease small-cell lung cancer"".",,2014,,['limited-disease small-cell lung cancer'],['concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy'],[],"[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}]",[],,0.0173946,,[],Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu233']
1496,32645830,Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation.,"Background:  There is little scientific evidence regarding the effectiveness of strengthening exercises on the foot's intrinsic musculature in improving the lower limb on the statics and dynamics in healthy individuals.  Method:  To evaluate the effect on foot posture with regard to the reinforcement of the short foot exercise (SFE) compared to another without a recognized biomechanical action, which we called the ""non-biomechanical function"" (NBF) exercise. A randomized clinical trial was carried out with 85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points. An experimental group ( n  = 42) did SFE training and a control group ( n  = 43) carried out NBF exercises. The foot posture was evaluated twice via the navicular drop (ND) test, and the FPI was assessed on the day of inclusion in the study (pre-intervention) and after four weeks of training (post-intervention).  Results:  Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training. However, the foot posture was modified in both groups with respect to its initial state, and the ND value decreased.  Conclusions:  SFE could be considered a useful tool to deal with pathologies whose etiology includes excessive pronation of the foot.",2020,Results:  Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training.,"['85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points', 'healthy individuals']","['strengthening exercises', 'SFE training and a control group ( n  = 43) carried out NBF exercises', 'short foot exercise (SFE', 'SFE']",['foot posture'],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0230473', 'cui_str': 'Both feet'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C1870204', 'cui_str': '(18F)1-(2-fluoroethyl)-4-((4-cyanophenoxy)methyl)piperidine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0576226', 'cui_str': 'Short foot'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",85.0,0.0321686,Results:  Statistically significant values were not found in foot posture between the experimental and the control groups when comparing before and after the training.,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pabón-Carrasco', 'Affiliation': 'Cruz Roja, Nursing Department, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Castro-Méndez', 'Affiliation': 'Podiatry Department, University of Seville, 41009 Seville, Spain.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Vilar-Palomo', 'Affiliation': 'Virgen del Rocío Hospital, 41013 Seville, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Jiménez-Cebrián', 'Affiliation': 'Nursing and Podiatry Department, University of Malaga, 29071 Malaga, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García-Paya', 'Affiliation': 'Nursing and Podiatry Department, University of Malaga, 29071 Malaga, Spain.'}, {'ForeName': 'Inmaculada C', 'Initials': 'IC', 'LastName': 'Palomo-Toucedo', 'Affiliation': 'Podiatry Department, University of Seville, 41009 Seville, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134882']
1497,32645840,Effect of a Game-Based Physical Education Program on Physical Fitness and Mental Health in Elementary School Children.,"Promotion of healthy active behaviors should start from early ages, as behaviors learned in youth are more likely to endure. A fundamental body of research in this field focuses on the implementation of programs within physical education (PE), thanks to its favorable characteristics. However, traditional PE based on exercise training and controlling styles seems to have weaker association with students' health benefits. For this reason, the aim of this study was to assess the effects of a game-based PE program on physical fitness and psychological health in schoolchildren aged 10 to 12 years old. A total of 252 students were distributed in experimental (EG, games-centered activities) and control (CG, traditional exercise training activities) groups. The program lasted 6 months. Health-related physical fitness components, psychological wellbeing, self-esteem, stress, and anxiety were assessed before and after the treatment. Both groups increased physical fitness at post-test; however, cardiorespiratory fitness did not improve. No differences were found between the groups at post-test. Our results show that games may be as effective as traditional training methods; yet, they suggest that PE alone may be insufficient for obtaining substantive benefits in cardiorespiratory fitness, regardless of the type of task presented.",2020,No differences were found between the groups at post-test.,"['Elementary School Children', 'A total of 252 students', 'schoolchildren aged 10 to 12 years old']","['exercise training', 'control (CG, traditional exercise training activities', 'Game-Based Physical Education Program', 'game-based PE program']","['Physical Fitness and Mental Health', 'physical fitness', 'Health-related physical fitness components, psychological wellbeing, self-esteem, stress, and anxiety', 'physical fitness and psychological health', 'cardiorespiratory fitness']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",252.0,0.0137873,No differences were found between the groups at post-test.,"[{'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Cocca', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Tirol, Austria.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Espino Verdugo', 'Affiliation': 'School of Sports Organization, Autonomous University of Nuevo Leon, San Nicolás de los Garza 66455, Mexico.'}, {'ForeName': 'Luis Tomás', 'Initials': 'LT', 'LastName': 'Ródenas Cuenca', 'Affiliation': 'School of Sports Organization, Autonomous University of Nuevo Leon, San Nicolás de los Garza 66455, Mexico.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Cocca', 'Affiliation': 'School of Sports Organization, Autonomous University of Nuevo Leon, San Nicolás de los Garza 66455, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17134883']
1498,32646041,Effects of Neuromuscular Electrical Stimulation Synchronized with Chewing Exercises on Bite Force and Masseter Muscle Thickness in Community-Dwelling Older Adults in South Korea: A Randomized Controlled Trial.,"This study is aimed at investigating the effects of synchronized neuromuscular electrical stimulation (NMES) and chewing exercises on bite force and the masseter muscle thickness in community-dwelling older adults.  Material and methods:  Forty older adults were enrolled in South Korea and randomly assigned to either an experimental or control group. The experimental group performed chewing exercises using the No-Sick Exerciser equipment synchronized with NMES applied to the bilateral masseter muscles, while the control group performed only chewing exercises. Both groups received interventions for 20 min/day, 5 days/week, for 6 weeks. Bite force was measured using the OCCLUZER device, and masseter muscle thickness was measured using a portable ultrasound.  Results:  Both groups showed a significant increase in bite force and masseter muscle thickness compared to baseline measurements ( p  < 0.05). The experimental group showed a significantly higher increase in bite force and masseter muscle thickness than the control group after combined intervention ( p  < 0.05).  Conclusion:  This study demonstrates that NMES synchronized with chewing exercises is more efficient in increasing bite force and masseter muscle thickness than chewing exercises alone in community-dwelling older adults.",2020,The experimental group showed a significantly higher increase in bite force and masseter muscle thickness than the control group after combined intervention ( p  < 0.05).  ,"['community-dwelling older adults', 'Community-Dwelling Older Adults in South Korea', 'Forty older adults were enrolled in South Korea']","['Neuromuscular Electrical Stimulation Synchronized with Chewing Exercises', 'NMES synchronized with chewing exercises', 'chewing exercises using the No-Sick Exerciser equipment synchronized with NMES applied to the bilateral masseter muscles, while the control group performed only chewing exercises', 'synchronized neuromuscular electrical stimulation (NMES) and chewing exercises']","['Bite force', 'Bite Force and Masseter Muscle Thickness', 'bite force and masseter muscle thickness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0589278', 'cui_str': 'Chewing exercises'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",40.0,0.0185005,The experimental group showed a significantly higher increase in bite force and masseter muscle thickness than the control group after combined intervention ( p  < 0.05).  ,"[{'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly Industry, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Min-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Hygiene, DongSeo University, Busan 47011, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17134902']
1499,32647023,Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol.,"INTRODUCTION


Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has  never  been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has automated data collection for surgical patients. Similarly, the 'REthinking Clinical Trials' (REaCT) platform increases RCT enrolment by simplifying pragmatic trial design. In this novel RCT protocol, we combine REaCT and NSQIP to compare OA alone versus no preparation for SSI rate reduction in elective colon surgery. To our knowledge, this is the first published RCT protocol that leverages NSQIP for data collection. In our feasibility study, 67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol. The 'REaCT-NSQIP' trial design has great potential to efficiently generate level I evidence for other perioperative interventions.
METHODS AND ANALYSIS


SSI rates following elective colorectal surgery after preoperative OA or no preparation will be compared. We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications. Consent, using the 'integrated consent model', and randomisation on a mobile device are completed by the surgeon in a single clinical encounter. Data collection for the primary end point is automatic through NSQIP. Analysis of cost per weighted case, cost utility and quality-adjusted life years will be done.
ETHICS AND DISSEMINATION


This study is approved by The Ontario Cancer Research Ethics Board. Results will be disseminated in surgical conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03663504; Pre-results, recruitment phase.",2020,"We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications.","['67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol', 'surgical patients', 'elective colon surgery']","['elective colorectal surgery after preoperative OA or no preparation', 'preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP', 'REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone', 'National Surgical Quality Improvement Program (NSQIP']","['length of stay, reduced costs and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.153862,"We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications.","[{'ForeName': 'Sameer S', 'Initials': 'SS', 'LastName': 'Apte', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Husein', 'Initials': 'H', 'LastName': 'Moloo', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ahwon', 'Initials': 'A', 'LastName': 'Jeong', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Vandemeer', 'Affiliation': 'Cancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Suh', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Faculty of Medicine, The University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Auer', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada rauer@ohri.ca.'}]",BMJ open,['10.1136/bmjopen-2020-036866']
1500,32525432,Leucine-enriched amino acids maintain peripheral mTOR-Rheb localization independent of myofibrillar protein synthesis and mTORC1 signaling postexercise.,"Postexercise protein ingestion can elevate rates of myofibrillar protein synthesis (MyoPS), mTORC1 activity, and mTOR translocation/protein-protein interactions. However, it is unclear if leucine-enriched essential amino acids (LEAA) can similarly facilitate intracellular mTOR trafficking in humans after exercise. The purpose of this study was to determine the effect of postexercise LEAA (4 g total EAAs, 1.6 g leucine) on acute MyoPS and mTORC1 translocation and signaling. Recreationally active men performed lower-body resistance exercise (5 × 8-10 leg press and leg extension) to volitional failure. Following exercise participants consumed LEAA ( n  = 8) or an isocaloric carbohydrate drink (PLA;  n  = 10). MyoPS was measured over 1.5-4 h of recovery by oral pulse of l-[ ring - 2 H 5 ]-phenylalanine. Phosphorylation of proteins in the mTORC1 pathway were analyzed via immunoblotting and mTORC1-LAMP2/WGA/Rheb colocalization via immunofluorescence microscopy. There was no difference in MyoPS between groups (LEAA = 0.098 ± 0.01%/h; PL = 0.090 ± 0.01%/h;  P  > 0.05). Exercise increased ( P  < 0.05) rpS6 Ser240/244 (LEAA = 35.3-fold; PLA = 20.6-fold), mTOR Ser2448 (LEAA = 1.8-fold; PLA = 1.2-fold) and 4EBP1 Thr37/46 (LEAA = 1.5-fold; PLA = 1.4-fold) phosphorylation irrespective of nutrition ( P  > 0.05). LAT1 and SNAT2 protein expression were not affected by exercise or nutrient ingestion. mTOR-LAMP2 colocalization was greater in LEAA preexercise and decreased following exercise and supplement ingestion ( P  < 0.05), yet was unchanged in PLA. mTOR-WGA (cell periphery marker) and mTOR-Rheb colocalization was greater in LEAA compared with PLA irrespective of time-point ( P  < 0.05). In conclusion, the postexercise consumption of 4 g of LEAA maintains mTOR in peripheral regions of muscle fibers, in closer proximity to its direct activator Rheb, during prolonged recovery independent of differences in MyoPS or mTORC1 signaling compared with PLA ingestion. This intracellular localization of mTOR may serve to ""prime"" the kinase for future anabolic stimuli. NEW & NOTEWORTHY  This is the first study to investigate whether postexercise leucine-enriched amino acid (LEAA) ingestion elevates mTORC1 translocation and protein-protein interactions in human skeletal muscle. Here, we observed that although LEAA ingestion did not further elevate postexercise MyoPS or mTORC1 signaling compared with placebo, mTORC1 peripheral location and interaction with Rheb were maintained. This may serve to ""prime"" mTORC1 for subsequent anabolic stimuli.",2020,"Exercise increased ( P  < 0.05) rpS6 Ser240/244 (LEAA = 35.3-fold; PLA = 20.6-fold), mTOR Ser2448 (LEAA = 1.8-fold; PLA = 1.2-fold) and 4EBP1 Thr37/46 (LEAA = 1.5-fold; PLA = 1.4-fold) phosphorylation irrespective of nutrition ( P  > 0.05).",['human skeletal muscle'],"['body resistance exercise', 'isocaloric carbohydrate drink', 'Leucine-enriched amino acids', 'l', 'postexercise LEAA (4 g total EAAs, 1.6 g leucine', 'postexercise leucine-enriched amino acid (LEAA) ingestion', 'exercise participants consumed LEAA', 'phenylalanine', 'Postexercise protein ingestion']","['mTOR-Rheb colocalization', 'LEAA preexercise', 'Exercise', 'myofibrillar protein synthesis (MyoPS), mTORC1 activity, and mTOR translocation/protein-protein interactions', 'mTOR', 'acute MyoPS and mTORC1 translocation and signaling', 'LAT1 and SNAT2 protein expression', 'MyoPS']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C3888046', 'cui_str': 'Target of Rapamycin Complex 1'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0596271,"Exercise increased ( P  < 0.05) rpS6 Ser240/244 (LEAA = 35.3-fold; PLA = 20.6-fold), mTOR Ser2448 (LEAA = 1.8-fold; PLA = 1.2-fold) and 4EBP1 Thr37/46 (LEAA = 1.5-fold; PLA = 1.4-fold) phosphorylation irrespective of nutrition ( P  > 0.05).","[{'ForeName': 'Sarkis J', 'Initials': 'SJ', 'LastName': 'Hannaian', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Hodson', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Abou Sawan', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mazzulla', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Technology Development Center, Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Matsunaga', 'Affiliation': 'Technology Development Center, Institute of Food Sciences and Technologies, Ajinomoto Co., Inc., Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Waskiw-Ford', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Duncan', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Dinesh A', 'Initials': 'DA', 'LastName': 'Kumbhare', 'Affiliation': 'Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Moore', 'Affiliation': 'Faculty of Kinesiology and Physical Education, Department of Exercise Science, University of Toronto, Toronto, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00241.2020']
1501,32649896,Flapless Piezotome Crest Split Achieves Comparable Outcomes to Autologous Onlay Grafts With Significant Less Patient Morbidity and Complications-A Randomized Clinical Study.,"PURPOSE


In the management of the narrow alveolar ridge, the flapless piezotome crest split (FPCS) technique with horizontal distraction was introduced as an alternative to lateral alveolar ridge augmentation using autologous bone block grafting (ABBG). The study purpose was to measure and compare the alveolar crest width and complications between FPCS and ABBG.
MATERIALS AND METHODS


We implemented a nonblinded, randomized clinical trial. The sample included patients requiring lateral alveolar ridge augmentation before implant insertion. The predictor variable was lateral alveolar ridge augmentation performed using ABBG (control group) or FPCS using an ultrasonic surgical device (Piezotome II or Piezotome CUBE; Acteon, Norwich, UK) and specific crest split working tips (test group). The primary outcome variable was the overall coronal crest width achieved after completed healing measured at 6 months using 3-dimensional imaging studies. Other study variables included the postoperative morbidity, staged using the Universal Pain Assessment Scale, complications, and surgery duration. Descriptive and bivariate statistics were computed using SPSS, version 22.0 (IBM Corp, Armonk, NY), and P ≤ .05 was considered to indicate statistical significance.
RESULTS


The sample included 567 patients treated with ABBG (56.1% female; age, 64.1 ± 20.2 years) and 562 treated with FPCS (57.2% female; age, 62.3 ± 18.2 years). The baseline crest width in the control and test groups was 2.1 ± 0.5 mm and 1.9 ± 0.4 mm, respectively. The final crest width achieved with ABBG and FPCS was 5.8 ± 0.8 mm and 6.5 ± 0.7 mm, respectively (P > .05). Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
CONCLUSIONS


FPCS seems to be a significantly less traumatic alternative to buccal onlay grafting with autologous bone blocks, providing a comparable or better net gain in the alveolar crest width with a significantly shorter operative time and less postoperative morbidity.",2020,"Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
","['567 patients treated with ABBG (56.1% female; age, 64.1\xa0±\xa020.2\xa0years) and 562 treated with FPCS (57.2% female; age, 62.3\xa0±\xa018.2\xa0years', 'patients requiring lateral alveolar ridge augmentation before implant insertion']","['Flapless Piezotome Crest Split', 'ABBG (control group) or FPCS', 'ultrasonic surgical device (Piezotome II or Piezotome CUBE', 'Autologous Onlay Grafts']","['postoperative morbidity, staged using the Universal Pain Assessment Scale, complications, and surgery duration', 'final crest width achieved with ABBG and FPCS', 'postoperative complication rate, morbidity, and operative time', 'alveolar crest width and complications', 'postoperative morbidity', 'baseline crest width', 'overall coronal crest width achieved after completed healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0002387', 'cui_str': 'Augmentation of alveolar ridge'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",567.0,0.067806,"Statistically significant differences (P < .05) were found between the ABBG and FPCS groups in the postoperative complication rate, morbidity, and operative time, all in favor of FPCS.
","[{'ForeName': 'Ziad Tarek', 'Initials': 'ZT', 'LastName': 'Mahmoud', 'Affiliation': 'Lecturer, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Electronic address: drziadtmahmoud@gmail.com.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Wainwright', 'Affiliation': 'Visiting Professor, Faculty of Dentistry, University of Seville, Seville, Spain.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Troedhan', 'Affiliation': 'Visiting Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Alexandria, Egypt; and Visiting Professor, Institute for Oral and Maxillofacial Surgery and Dentistry, General Hospital ""Krankenhaus Hietzing"" of the City of Vienna, Vienna, Austria.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.06.008']
1502,32650033,Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications.,"AIM


Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required.
METHODS


We compared improvement in glycaemic control in a pooled set of people assigned to the ""placebo"" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated.
RESULTS


The overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between -0.23% (-2.50 mmol/mol) and -0.32% (-3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months.
CONCLUSIONS


Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.",2020,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"['people with diabetes and their healthcare team', 'people with diabetes', 'younger and older adults with diabetes having comorbidities and progressive complications', 'people living with diabetes']","['sham or non-pharmacological intervention', 'placebo']","['metabolic parameters', 'fasting plasma glucose', 'Mean change in HbA1c (ANCOVA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.202893,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"[{'ForeName': 'William David', 'Initials': 'WD', 'LastName': 'Strain', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom; Academic Department of Healthcare for the Elderly, Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom. Electronic address: d.strain@exeter.ac.uk.'}, {'ForeName': 'Päivi Maria', 'Initials': 'PM', 'LastName': 'Paldánius', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108310']
1503,32652388,"Buying despite negative consequences: Interaction of craving, implicit cognitive processes, and inhibitory control in the context of buying-shopping disorder.","BACKGROUND


Buying-shopping disorder (BSD) is a severe mental disorder in which individuals lose control over their buying/shopping behavior. It is debated whether BSD shares characteristics with other behavioral addictions. The current study aimed at investigating addiction-related concepts, i.e. cue-reactivity/craving, implicit cognitions, and inhibitory control mechanisms, in the context of BSD.
METHODS


An analog sample of 277 participants completed a cue-reactivity paradigm with shopping-related pictures. To assess implicit cognitions (attentional bias and implicit associations) and inhibitory control, a visual dot probe paradigm, an implicit association test, and an affective shifting task, all with shopping-related and control pictures, were administered. The sequence of the three tasks was randomized across participants. Craving was measured prior and after the cue-reactivity paradigm and after completion of the experimental procedure. BSD severity was assessed using the Pathological Buying Screener (PBS).
RESULTS


Increases in craving during the cue-reactivity paradigm, but decreases after the experimental procedure were observed. Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control. However, we found moderating effects of attentional bias and inhibitory control as well as implicit associations and inhibitory control on the relationship between craving and BSD severity.
DISCUSSION/CONCLUSION


Results emphasize the role of cue-reactivity/craving, implicit cognitions and inhibitory control in the context of BSD. In line with models for behavioral addictions (I-PACE; Brand et al., 2019), the interaction of affective and cognitive biases towards shopping cues and dysfunctional inhibitory control mechanisms seems to explain the pathological engagement in buying/shopping despite negative consequences.",2020,"Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control.",['An analog sample of 277 participants completed a cue-reactivity paradigm with shopping-related pictures'],[],"['Craving', 'BSD severity', 'Craving, attentional bias and implicit cognitions', 'Pathological Buying Screener (PBS', 'implicit cognitions (attentional bias and implicit associations']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",[],"[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",277.0,0.020093,"Craving, attentional bias and implicit cognitions were related to BSD severity-but not to inhibitory control.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Trotzke', 'Affiliation': 'Department of General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany; Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen, Germany. Electronic address: patrick.trotzke@uni-due.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of General Psychology: Cognition and Center for Behavioral Addiction Research (CeBAR), University of Duisburg-Essen, Duisburg, Germany; Erwin L. Hahn Institute for Magnetic Resonance Imaging, Essen, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Starcke', 'Affiliation': 'SRH Berlin School of Popular Arts, Berlin, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Steins-Loeber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106523']
1504,32658264,Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.,"CONTEXT


Abaloparatide is a US Food and Drug Administration-approved parathyroid hormone-related peptide analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
OBJECTIVES


We assessed the cardiovascular safety profile of abaloparatide.
DESIGN


Review of heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACEs) and heart failure (HF) from: (a) ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months; (b) ACTIVExtend (NCT01657162), where participants from the abaloparatide and placebo arms received alendronate for 2 years; and (c) a pharmacology study in 55 healthy adults.
RESULTS


Abaloparatide and teriparatide transiently increased HR relative to placebo. Following first dose, mean (standard deviation [SD]) HR change from pretreatment to 1 hour posttreatment was 7.9 (8.5) beats per minute (bpm) for abaloparatide, 5.3 (7.5) for teriparatide, and 1.2 (7.1) for placebo. A similar pattern was observed over subsequent visits. In healthy volunteers, HR increase resolved within 4 hours. The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo). The percentage of participants with serious cardiac AEs was similar among groups (0.9%-1.0%). In a post hoc analysis, time to first incidence of MACE + HF was longer with abaloparatide (P = 0.02 vs placebo) and teriparatide (P = 0.04 vs placebo).
CONCLUSIONS


Abaloparatide was associated with transient increases in HR and small decreases in BP in postmenopausal women with osteoporosis, with no increase in risk of serious cardiac AEs, MACE, or HF.",2020,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","['postmenopausal women at high risk of fracture', 'Postmenopausal Women with Osteoporosis', 'postmenopausal women with osteoporosis', 'healthy volunteers', 'for 18 months', '2463 postmenopausal women with osteoporosis to abaloparatide', '55 healthy adults']","['teriparatide', 'teriparatide, or placebo', 'Abaloparatide', 'alendronate', 'abaloparatide and placebo', 'placebo']","['heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACE) and heart failure (HF', 'mean (SD) HR change', 'risk of serious cardiac AEs, MACE, or HF', 'mean supine systolic and diastolic BP', 'percentage of participants with serious cardiac AEs', 'Cardiovascular Safety', 'HR relative']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",2463.0,0.501999,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","[{'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Diabetic Cardiovascular Disease Center and Department of Medicine, Washington University, St Louis, Missouri.'}, {'ForeName': 'Dwight A', 'Initials': 'DA', 'LastName': 'Towler', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Clinical Development, Radius Health, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Radius Health, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Cummings', 'Affiliation': 'San Francisco Coordinating Center, Sutter Health, California; University of California, San Francisco, California.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa450']
1505,32653539,The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.,"Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.",2020,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","['African American adults with uncontrolled diabetes and multiple chronic health conditions', ' African American patients with uncontrolled diabetes living in medically underserved areas', 'Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability', '646 patients (n\u202f=\u202f581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC', 'African Americans individuals with uncontrolled diabetes']","['Text messaging (TM) and health coaching (HC', 'text messaging versus health coaching', 'TM and HC with enhanced usual care (EC']","['diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c', 'general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",646.0,0.105121,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Bailey', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America. Electronic address: jeb@uthsc.edu.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Surbhi', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gatwood', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Butterworth', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Q-consult, LLC, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Sohul A', 'Initials': 'SA', 'LastName': 'Shuvo', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ankur A', 'Initials': 'AA', 'LastName': 'Dashputre', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Brooks', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Surgery, Anne Arundel Medical Center, Annapolis, MD, United States of America.'}, {'ForeName': 'Bonnie L', 'Initials': 'BL', 'LastName': 'Binkley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Carrie Jo', 'Initials': 'CJ', 'LastName': 'Riordan', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Helmut O', 'Initials': 'HO', 'LastName': 'Steinberg', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of Endocrinology, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Gutierrez', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Haley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Cardella L', 'Initials': 'CL', 'LastName': 'Leak', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tolley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106080']
1506,32654884,Decreased neural inhibitory state in fibromyalgia pain: A cross-sectional study.,"OBJECTIVES


Chronic pain is one of the most common and challenging symptoms in fibromyalgia (FM). Currently, self-reported pain is the main criterion used by clinicians assessing patients with pain. However, it is subjective, and multiple factors can affect pain levels. In this study, we investigated the neural correlates of FM pain using conditioned pain modulation (CPM), electroencephalography (EEG), and transcranial magnetic stimulation (TMS).
METHODS


In this cross-sectional neurophysiological analysis of a randomized, double-blind controlled trial, 36 patients with fibromyalgia were included. We analyzed CPM, EEG variables and TMS measures and their correlation with pain levels as measured by a visual analog scale. Univariate and multivariate linear regression analyses were performed to identify the predictors of pain severity.
RESULTS


We found: (1) no association between pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels; (3) an association between smaller event-related desynchronization (ERD) responses in theta and delta bands over the central region and higher pain levels; (4) an association between smaller ERD responses in theta and delta bands and smaller intracortical inhibition and higher intracortical facilitation ratios; (5) an association between smaller ERD responses in delta band and reduced CPM.
CONCLUSIONS


Our results do not support CPM as a biomarker for pain intensity in FM. However, our specific EEG findings showing the relationship between pain, CPM and TMS measures suggest that FM leads to a disruption of inhibitory neural modulators and thus support CPM as a likely predictive marker of disrupted pain modulation system. These neurophysiological markers need to be further explored in potential future trials as to find novel targets for the treatment of FM.",2020,"We found: (1) no association between pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels; (3) an association between smaller event-related desynchronization (ERD) responses in theta and delta bands over the central region and higher pain levels; (4) an association between smaller ERD responses in theta and delta bands and smaller intracortical inhibition and higher intracortical facilitation ratios; (5) an association between smaller ERD responses in delta band and reduced CPM.
","['36 patients with fibromyalgia were included', 'patients with pain', 'fibromyalgia pain']","['conditioned pain modulation (CPM), electroencephalography (EEG), and transcranial magnetic stimulation (TMS']","['neural inhibitory state', 'pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels', 'pain intensity', 'CPM, EEG variables and TMS measures and their correlation with pain levels', 'pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0454907', 'cui_str': 'Central region'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332287', 'cui_str': 'With'}]",36.0,0.123009,"We found: (1) no association between pain levels and CPM; (2) an association between reduced alpha and beta power over the central region in resting-EEG and higher pain levels; (3) an association between smaller event-related desynchronization (ERD) responses in theta and delta bands over the central region and higher pain levels; (4) an association between smaller ERD responses in theta and delta bands and smaller intracortical inhibition and higher intracortical facilitation ratios; (5) an association between smaller ERD responses in delta band and reduced CPM.
","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur-Kucukseymen', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Castelo-Branco', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Lima, Peru.'}, {'ForeName': 'Maria Alejandra', 'Initials': 'MA', 'LastName': 'Luna-Cuadros', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Cardenas-Rojas', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Giannoni-Luza', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA; Department of Endocrinology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Anna Carolyna', 'Initials': 'AC', 'LastName': 'Gianlorenco', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA; Department of Physical Therapy, Federal University of Sao Carlos, Brazil.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Gnoatto-Medeiros', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Emad Salman', 'Initials': 'ES', 'LastName': 'Shaikh', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 96-13th Street, Charlestown, Boston, MA, USA. Electronic address: Fregni.Felipe@mgh.harvard.edu.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2020.06.002']
1507,32659480,Effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia: A randomized controlled trial.,"PURPOSE


The present study aimed to assess the effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia.
METHODS


Thirty-four participants with behavioral dysphonia were randomly assigned to one of two treatment groups: 1) voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program only (n=14). Laryngoscopic assessment was performed in all subjects. Before and after voice therapy, participants underwent aerodynamic, electroglottographic, and acoustic assessment. The Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE). Comparison for all variables were performed between experimental group and control group.
RESULTS


Wilcoxon test showed significant improvements for experimental group for VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase). Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
CONCLUSION


Physiologic voice therapy based on semioccluded vocal tract exercises seems to be an effective tool to improve voice in subjects diagnosed with behavioral dysphonia. Apparently, most changes should be expected in variables related to physical and functional aspects compared to objective variables. Subglottic pressure and phonation threshold pressure seem to be the most change-sensitive parameters and they may reflect a reduction in phonatory effort reported by patients after voice therapy.",2020,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","['subjects diagnosed with behavioral dysphonia', 'Thirty-four participants with behavioral dysphonia', 'subjects with behavioral dysphonia']","['physiologic voice therapy program', 'phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE', 'voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program', 'Physiologic voice therapy']","['VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase', 'Subglottic pressure and phonation threshold pressure', 'Laryngoscopic assessment', 'Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality', 'subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",34.0,0.0112718,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile; Department of Otolaryngology, Las Condes Clinic, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bertucci', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: terebertucci@gmail.com.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Pacheco', 'Affiliation': 'Department of Otolaryngology, Las Condes Clinic, Av. Estoril 850, Santiago, Chile. Electronic address: cpachecob@clinicalascondes.cl.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leiva', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad Pedro de Valdivia, Vicuña Mackena 44, Santiago, Chile. Electronic address: fernando.leiva.solari@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Quintana', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: quintana.b.felipe@gmail.com.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Ansaldi', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad de las Américas, Santiago, Chile. Electronic address: romina.ansaldi@gmail.com.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: cequezad@uc.cl.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Department of Otolaryngology, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: daniel.uchile@gmail.com.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106023']
1508,32660953,Novel education-based intervention to reduce inappropriate antibiotic prescribing for treatment of gonorrhoea in China: protocol for a cluster randomised controlled trial.,"INTRODUCTION


Inappropriate use of antibiotics to treat gonorrhoea can lead to antibiotic resistance. Education programmes may be helpful for improving physician prescribing behaviours in accordance with treatment guidelines. As traditional education based on printed materials may have limited effect on guideline-based treatment, innovative education strategies are needed. The current trial aims to assess the effectiveness of a novel education intervention to increase guideline-based treatment of gonorrhoea in China.
METHODS AND ANALYSIS


We will conduct a two-arm cluster randomised control trial at 144 hospitals (clusters) in eight Chinese provinces. The intervention will include an online training video developed on the WenJuanXing platform that covers workflows and requirements for managing a patient with uncomplicated gonorrhoea. Outpatient physicians in dermatology (dermatovenerology), urology, andrology and gynaecology will be given access to the video via a quick response code. In hospitals allocated to the control arm, physicians will continue to participate in their standard of care training programme. The primary outcome is the proportion of gonorrhoea antibiotic prescriptions adherent to Chinese national guidelines at the cluster level. In addition, to understand the reasons of physician's non-adherence to the intervention by conducting a questionnaire survey will be considered as the secondary outcome of the study.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Medical Ethics Committee of the Chinese Academy of Medical Sciences Institute of Dermatology (2020-LS-004). All physicians will provide an informed consent prior to participating in the study. Findings of the trial will be disseminated through conferences and peer-reviewed journals, and will be used to develop training programmes for physicians.
TRIAL REGISTRATION NUMBER


ChiCTR2000029591.",2020,"The current trial aims to assess the effectiveness of a novel education intervention to increase guideline-based treatment of gonorrhoea in China.
","['144 hospitals (clusters) in eight Chinese provinces', 'Outpatient physicians in dermatology (dermatovenerology), urology, andrology and gynaecology', 'gonorrhoea in China']","['novel education intervention', 'Novel education-based intervention']",['proportion of gonorrhoea antibiotic prescriptions adherent to Chinese national guidelines at the cluster level'],"[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0085806', 'cui_str': 'Andrology'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",144.0,0.107048,"The current trial aims to assess the effectiveness of a novel education intervention to increase guideline-based treatment of gonorrhoea in China.
","[{'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Jiang', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Yun-Qing', 'Initials': 'YQ', 'LastName': 'Yang', 'Affiliation': 'Department of prevention and health care, Guangzhou Institute of Dermatology, Guangzhou, China.'}, {'ForeName': 'Ning-Xiao', 'Initials': 'NX', 'LastName': 'Cao', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Yin', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Xiang-Sheng', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China chenxs@ncstdlc.org.'}]",BMJ open,['10.1136/bmjopen-2020-037549']
1509,32665432,Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate.,"OBJECTIVES


Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment.
METHODS


Children aged 4-17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1).
RESULTS


Of 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
CONCLUSIONS


Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.",2020,"Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
","['Children aged 4-17\xa0years with polyarticular JIA', 'patients with polyarticular juvenile idiopathic arthritis receiving', 'patients with juvenile idiopathic arthritis (JIA', '171 patients enrolled, 62 (36%) completed the long-term extension']","['adalimumab with or without methotrexate', 'adalimumab', 'placebo']","['Mean JADAS27', 'clinical remission (JADAS27', 'efficacy assessments included JIA American College of Rheumatology (JIA ACR', '27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1', 'JIA ACR 30/50/70/90 responses and JADAS27 LDA', 'Adverse events (AEs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4521004', 'cui_str': 'Polyarticular juvenile idiopathic arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",11.0,0.208291,"Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lovell', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA Daniel.lovell@cchmc.org.""}, {'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Andreas O', 'Initials': 'AO', 'LastName': 'Reiff', 'Affiliation': 'Department of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Jung', 'Affiliation': ""Department of Rheumatology, Children's National Medical Center for Cancer and Immunology Research, Washington, District of Columbia, USA.""}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Jarosova', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Němcová', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mouy', 'Affiliation': 'Pediatric Rheumatology, Univeristé Paris-Descartes and Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Sandborg', 'Affiliation': ""Pediatric Rheumatology, Lucile Packard Children's Hospital at Stanford, Palo Alto, California, USA.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Bohnsack', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology and Pediatric Rheumatology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elewaut', 'Affiliation': 'Rheumatology, University Hospital Gent, Gent, Belgium.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Gabriel', 'Affiliation': ""Pediatric Rheumatology, Children's Hospital of the King's Daughters, Norfolk, Virginia, USA.""}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Higgins', 'Affiliation': 'Department of Pediatrics, The Ohio State University College of Medicine, Columbus, Ohio, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Kone-Paut', 'Affiliation': 'Department of Paediatric Rheumatology and CEREMAI, Hôpital De Bicêtre, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, Paris, France.'}, {'ForeName': 'Olcay Y', 'Initials': 'OY', 'LastName': 'Jones', 'Affiliation': 'Pediatric Rheumatology, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Vargová', 'Affiliation': 'Pediatric Rheumatology Unit, Faculty Hospital, Kosice, Slovakia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chalom', 'Affiliation': 'Pediatric-Rheumatology, Saint Barnabas Medical Center, Livingston, New Jersey, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Wouters', 'Affiliation': 'Pediatric Immunology, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lagunes', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI),, Università degli Studi di Genova, Genoa, Italy.'}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Clinica Pediatrica e Reumatologia-PRINTO, IRCCS Istituto Giannina Gaslini, Genova, Italy.'}]",RMD open,['10.1136/rmdopen-2020-001208']
1510,32665433,"Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study.","OBJECTIVE


To evaluate the effect of guselkumab on enthesitis and dactylitis in a phase II trial of patients with active psoriatic arthritis (PsA).
METHODS


This was a phase II, randomised, placebo-controlled, double-blind trial of adults with active PsA (≥3 swollen and ≥3 tender joints and C reactive protein ≥0.3 mg/dL) despite conventional synthetic disease-modifying anti-rheumatic drug, non-steroidal anti-inflammatory drug, and/or oral corticosteroid therapy. Patients were randomised to subcutaneous injections of guselkumab 100 mg or placebo at weeks 0, 4 and every 8 weeks, with placebo crossover to guselkumab at week 24. Dactylitis was scored on a scale of 0-3 on each digit; enthesitis was assessed using the Leeds Enthesitis Index (0-6). Other assessments included American College of Rheumatology (ACR) and Psoriasis Area and Severity Index responses.
RESULTS


Of 149 randomised patients, 107 patients had enthesitis (mean score=2.7) and 81 patients had dactylitis (mean dactylitis score=5.7) at baseline. Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56. Similar results were observed for the proportions of patients with resolution of enthesitis and dactylitis. At week 56, mean improvements in enthesitis and dactylitis among patients who switched from placebo to guselkumab treatment were similar to those in the guselkumab group. In the guselkumab group, ACR20 responders had greater improvements in enthesitis and dactylitis versus non-responders (week 24).
CONCLUSIONS


At week 24, the guselkumab group had greater mean improvements in enthesitis and dactylitis and greater proportions of patients with resolution of enthesitis and dactylitis versus placebo. ACR20 response was associated with improvements in enthesitis and dactylitis.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov: NCT02319759.URL: https://clinicaltrials.gov/ct2/show/NCT02319759; Registered 18 December 2014.",2020,Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56.,"['patients with moderate to severe psoriatic arthritis', 'Of 149 randomised patients, 107 patients had enthesitis (mean score=2.7) and 81 patients had dactylitis (mean dactylitis score=5.7) at baseline', 'adults with active PsA (≥3 swollen and ≥3 tender joints and C reactive protein ≥0.3 mg/dL) despite conventional synthetic disease-modifying anti-rheumatic drug, non-steroidal anti-inflammatory drug, and/or oral corticosteroid therapy', 'patients with active psoriatic arthritis (PsA']","['guselkumab', 'https://clinicaltrials.gov/ct2/show/NCT02319759', 'guselkumab 100 mg or placebo', 'NCT02319759.URL', 'placebo']","['American College of Rheumatology (ACR) and Psoriasis Area and Severity Index responses', 'enthesitis and dactylitis', 'resolution of enthesitis and dactylitis', 'ACR20 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}]",,0.345895,Mean improvements in enthesitis and dactylitis at week 24 were greater in the guselkumab group versus placebo and sustained through week 56.,"[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington, USA pmease@philipmease.com.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Dennis G', 'Initials': 'DG', 'LastName': 'McGonagle', 'Affiliation': 'Chapel Allerton Hospital, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Brisbane, Australia.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mt Sinai, NewYork, NewYork, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development LLC, La Jolla, California, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.'}, {'ForeName': 'Chetan S', 'Initials': 'CS', 'LastName': 'Karyekar', 'Affiliation': 'Janssen Global Services LLC, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'Section of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.'}]",RMD open,['10.1136/rmdopen-2020-001217']
1511,32649760,"Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial.","BACKGROUND


Maternal supplementation during lactation could increase milk B-vitamin concentrations, but little is known about the kinetics of milk vitamin responses.
OBJECTIVES


We compared acute effects of maternal lipid-based nutrient supplement (LNS) consumption (n = 22 nutrients, 175%-212% of the RDA intake for the nutrients examined), as a single dose or at spaced intervals during 8 h, on milk concentrations and infant intake from milk of B-vitamins.
METHODS


This randomized crossover trial in Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum who were randomly assigned to receive 3 treatments in a random order: bolus 30-g dose of LNS (Bolus); 3 × 10-g doses of LNS (Divided); and no LNS (Control), with control meals. Mothers attended three 8-h visits during which infant milk consumption was measured and milk samples were collected at every feed. Infant intake was assessed as $\mathop \sum \nolimits_{i\ = \ 1}^n ( {{\rm{milk\ volum}}{{\rm{e}}_{{\rm{feed\ }}n}} \times \ {\rm{nutrient\ concentratio}}{{\rm{n}}_{{\rm{feed}}\ n}}} )$ over 8 h.
RESULTS


Maternal supplementation with the Bolus or Divided dose increased least-squares mean (95% CI) milk and infant intakes of riboflavin [milk: Bolus: 154.4 (138.2, 172.5) μg · min-1 · mL-1; Control: 84.5 (75.8, 94.3) μg · min-1 · mL-1; infant: Bolus: 64.5 (56.1, 74.3) μg; Control: 34.5 (30.0, 39.6) μg], thiamin [milk: Bolus: 10.9 (10.1, 11.7) μg · min-1 · mL-1; Control: 7.7 (7.2, 8.3) μg · min-1 · mL-1; infant: Bolus: 5.1 (4.4, 6.0) μg; Control: 3.4 (2.9, 4.0) μg], and pyridoxal [milk: Bolus: 90.5 (82.8, 98.9) μg · min-1 · mL-1; Control: 60.8 (55.8, 66.3) μg · min-1 · mL-1; infant: Bolus: 39.4 (33.5, 46.4) μg; Control: 25.0 (21.4, 29.2) μg] (all P < 0.001). Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018) μg, P = 0.001] compared with Control. Niacin was unaffected.
CONCLUSIONS


Maternal supplementation with LNS as a Bolus or Divided dose was similarly effective at increasing milk riboflavin, thiamin, and pyridoxal and infant intakes, whereas only the Bolus dose increased cobalamin. Niacin was unaffected in 8 h. This trial was registered at clinicaltrials.gov as NCT02464111.",2020,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","['lactating Guatemalan women acutely increases infants', 'Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum']","['Niacin', 'LNS (Divided); and no LNS (Control), with control meals', 'maternal lipid-based nutrient supplement (LNS) consumption', 'LNS (Bolus); 3\xa0×', 'Micronutrient supplementation']","[' intake of riboflavin, thiamin, pyridoxal, and cobalamin', 'Infant intake', 'milk B-vitamin concentrations', ' 1}^n ( {{\\rm{milk\\ volum}}{{\\rm{e}}_{{\\rm{feed\\ }}n}} \\times \\ {\\rm{nutrient\\ concentratio}}{{\\rm{n}}_{{\\rm{feed}}\\ n}}} ', 'milk riboflavin, thiamin, and pyridoxal and infant intakes', 'least-squares mean']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0034263', 'cui_str': 'Pyridoxal'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.372535,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","[{'ForeName': 'Juliana A', 'Initials': 'JA', 'LastName': 'Donohue', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Solomons', 'Affiliation': 'Center for Studies of Sensory Impairment, Aging and Metabolism, Guatemala City, Guatemala.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hampel', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Mónica N', 'Initials': 'MN', 'LastName': 'Orozco', 'Affiliation': 'Center for Atitlán Studies, Universidad del Valle de Guatemala, Sololá, Guatemala.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa147']
1512,32649395,Effects of an Active Music Therapy Program on Functional Fitness in Community Older Adults.,"BACKGROUND


Health problems common among older adults living in community settings include a lack of functional fitness. Many studies have confirmed that exercises and static music therapy improve physical and psychological health problems. Exercise programs involving music have a higher frequency of attendance and motivation than other exercise programs. Active participation in active group music therapy results in better therapeutic effects.
PURPOSE


This study was designed to test the effectiveness of a 3-month active group music therapy program on the functional fitness of community older adults in Taiwan.
METHODS


A quasi-experimental design with repeated measures was applied. A convenience cluster sample of older adults was drawn from seven senior-citizen activity centers in southern Taiwan. All participants were assigned to either an experimental group (n = 77) or a comparison group (n = 69) based on the requests of each senior center. The experimental group participated in the active group music therapy program for 3 months (twice per week and 60 minutes per session). The comparison group maintained their daily activities. Each participant's level of functional fitness was measured at baseline and at 1 and 3 months after the start of the intervention.
RESULTS


Seventy-one participants in the experimental group and 62 participants in the comparison group completed the 3-month study. At the 1-month measurement, the experimental group had greater improvements in cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance than the comparison group (all ps < .05). These significant improvements persisted through the 3-month intervention (all ps < .05).
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


Active group music therapy is an effective complementary and alternative therapy for improving six items of functional fitness in community-dwelling older adults. Healthcare professionals may incorporate this active group music therapy program as a health promotion activity for older adults living in community settings.",2020,"At the 1-month measurement, the experimental group had greater improvements in cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance than the comparison group (all ps < .05).","['older adults was drawn from seven senior-citizen activity centers in southern Taiwan', 'Seventy-one participants in the experimental group and 62 participants in the comparison group completed the 3-month study', 'community-dwelling older adults', 'Community Older Adults', 'older adults living in community settings', 'community older adults in Taiwan']","['Active Music Therapy Program', 'active group music therapy program', 'static music therapy']","['cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance', 'level of functional fitness', 'Functional Fitness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441463', 'cui_str': 'Static'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0190018,"At the 1-month measurement, the experimental group had greater improvements in cardiopulmonary fitness, upper body flexibility, lower body flexibility, upper limb muscle power, lower limb muscle endurance, and balance than the comparison group (all ps < .05).","[{'ForeName': 'Shu-Ya', 'Initials': 'SY', 'LastName': 'Chan', 'Affiliation': 'PhD, RN, Assistant Professor, Department of Nursing, Chung Hwa University of Medical Technology, Taiwan, ROC.'}, {'ForeName': 'Chun-Fei', 'Initials': 'CF', 'LastName': 'Chen', 'Affiliation': 'BSN, RN, Research Assistant, Department of Nursing, Chung Hwa University of Medical Technology, Taiwan, ROC.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000391']
1513,32653726,High rate of antimicrobial resistance and multiple mutations in the dihydrofolate reductase gene among Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania.,"OBJECTIVES


The aim of this study was to characterize molecular mechanisms of resistance to trimethoprim and other antibiotics in Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania.
METHODS


A total of 1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a 1-year follow-up from 2017-2018 as part of the randomized clinical trial CoTrimResist (ClinicalTrials.gov ID: NCT03087890).
RESULTS


A total of 76 pneumococcal isolates were obtained. Of the 70 isolates that could be serotyped, 42 (60.0%) were vaccine serotypes included in pneumococcal conjugate vaccine 23 (PCV23). The majority of isolates (73.7%; 56/76) were non-susceptible to penicillin (MICs of 0.06-2μg/mL). Isolates were frequently resistant to co-trimoxazole (trimethoprim/sulfamethoxazole) (71.1%) but less so to azithromycin (22.4%), erythromycin (21.1%), chloramphenicol (18.4%), tetracycline (14.5%), clindamycin (10.5%) and levofloxacin (0%). Moreover, 26.3% were multidrug-resistant (resistant to ≥3 antibiotic classes). Vaccine-type pneumococci were resistant to more classes of antibiotics, were more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MICs to penicillin (median, 0.19μg/mL; range, 0.002-1.5μg/mL) compared with non-vaccine serotypes (median, 0.125μg/mL; range, 0.012-0.25μg/mL) (P=0.003). Co-trimoxazole-resistant isolates carried from 1 to 11 different mutations in the dihydrofolate reductase (DHFR) gene, most commonly Ile100Leu (100%), Glu20Asp (91.8%), Glu94Asp (61.2%), Leu135Phe (57.1%), His26Tyr (53.1%), Asp92Ala (53.1%) and His120Gln (53.1%).
CONCLUSION


Streptococcus pneumoniae isolated from HIV-diagnosed patients were frequently non-susceptible to penicillin and co-trimoxazole. Most isolates carried multiple mutations in DHFR.",2020,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","['1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a one-year follow-up from 2017 -2018', 'Twenty-six percent were multi-drug resistant (resistant to ≥3 antibiotic classes', 'Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania', 'Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania']","['clindamycin', 'tetracycline', 'erythromycin, azithromycin, clindamycin and tetracycline', 'levofloxacin', 'chloramphenicol', 'erythromycin', 'azithromycin']",['penicillin non-susceptible minimum inhibitory concentration (MIC'],"[{'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0008168', 'cui_str': 'Chloramphenicol'}]","[{'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0427978', 'cui_str': 'MIC'}]",1877.0,0.4074,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Manyahi', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania. Electronic address: manyahijoel@yahoo.com.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Langeland', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Blomberg', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2020.06.026']
1514,32654447,[Analysis of the safety and efficacy of bronchial thermoplasty for severe asthma with the first second forced expiratory volume (FEV(1)) as a percentage of the predicted value (FEV(1)%pred)<60].,"Objective:  To investigate the efficacy and safety of bronchial thermoplasty (BT) in severe asthma patients with the first second forced expiratory volume (FEV(1)) as a percentage of the predicted value (FEV(1)%pred) <60%.  Methods:  A retrospective analysis was performed on 75 patients with asthma who were treated with BT at Shenzhen University Hospital of the Chinese Academy of Sciences from January 2016 to January 2018. The patients were divided into two groups based on the FEV(1)%pred before treatment: FEV(1)%pred <60% group (39 cases) and FEV(1)%pred ≥60% group (36 cases). Comparative analysis of glucocorticoid consumption, times of acute attack, asthma control test (ACT) score, changes in lung function, and adverse reactions at 3 weeks after treatment were performed between the two groups of patients.  Results:  Before BT treatment, the consumption of oral prednisone, the amount of budesonide inhaled, and the times of acute attack [ M  ( Q (1),  Q (3))] in the FEV(1)%pred <60% group were significantly greater than those in the FEV(1)%pred ≥60% group, and the ACT score was significantly lower than the FEV(1)%pred ≥60% group [10.00 (0, 20.00) vs 0(0, 3.75) mg/d, 960 (320, 960) vs 320 (320, 640) μg/d, 5(4, 8) vs 4 (4, 5) times/year, 13 (9, 15) vs 17 (13, 19) scores] (all  P< 0.05). Except that the oral prednisone dosage in the FEV(1)%pred<60% group was still higher 1 year after treatment [0 (0, 5.00) vs 0 (0, 0) mg/d] ( P= 0.009), there was no significant difference in the remaining indicators between the two groups 1 year after treatment and 2 years after treatment (all  P> 0.05). After 1 year and 2 years of treatment, all indicators in the two groups were better than before treatment (all  P< 0.05). The inhaled budesonide amount and the times of acute exacerbation in the FEV(1)%pred <60% group 2 years after treatment were less than those 1 year after treatment [320 (320, 320) vs 320 (320, 640) μg/d, 0 (0, 0) vs 0(0, 1) times/year] (all  P< 0.05), and there was no significant difference in the remaining indicators. In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05). In the FEV(1)%pred <60% group, FEV(1) and the FEV(1)%pred were significantly lower than the FEV(1)%pred ≥60% group before treatment, 1 year after treatment and 2 years after treatment [FEV(1):(1.21±0.41) vs (2.26±0.80)L, (1.84±0.73) vs (2.30±0.78)L, (1.70±0.66) vs (2.38±0.76)L; FEV(1)%pred:46.2 (38.5, 53.7)% vs 80.8(66.5, 93.6)%, 60.1 (48.2, 71.6)% vs 87.4 (68.5, 96.5)%, 58.5 (48.6, 74.8)% vs 86.6 (73.0, 97.3)%] (all  P< 0.05). In the FEV(1)%pred <60% group, FEV(1) and FEV(1)%pred 1 year after treatment and 2 years after treatment were all increased compared with before treatment (all  P< 0.05). In the FEV(1)%pred ≥60% group, there was no statistical difference in FEV(1) at each time point before and after treatment (all  P> 0.05), but the FEV(1)%pred at 2 years after treatment was higher than before treatment ( P< 0.05). There were no significant differences in adverse events between the two groups (all  P> 0.05).  Conclusion:  BT can significantly improve the lung function, reduce the times of acute attack and the dosage of glucocorticoids in severe asthma patients with FEV(1)% pred<60%, which is safe and effective.",2020,"In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05).","['75 patients with asthma who were treated with BT at Shenzhen University Hospital of the Chinese Academy of Sciences from January 2016 to January 2018', 'severe asthma patients with the first second forced expiratory volume (FEV(1']","['bronchial thermoplasty (BT', 'BT', 'FEV(1)%pred']","['acute exacerbation', 'FEV(1', 'FEV(1)%pred', 'consumption of oral prednisone, the amount of budesonide inhaled, and the times of acute attack [ M  ( Q (1),  Q (3', 'lung function', 'adverse events', 'ACT score', 'glucocorticoid consumption, times of acute attack, asthma control test (ACT) score, changes in lung function, and adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]","[{'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",75.0,0.0274246,"In the FEV(1)%pred ≥60% group, there was no significant difference between 2 years after treatment and 1 year after treatment in the above indicators except the amount of inhaled budesonide (all  P> 0.05).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'W T', 'Initials': 'WT', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Shenzhen Hospital of Chinese Academy of Sciences, Shenzhen 518106, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200119-00127']
1515,32658610,Correction to: Results of the FUEL Trial.,,2020,,[],[],[],[],[],[],,0.0268756,,[],Circulation,['10.1161/CIR.0000000000000882']
1516,32659482,Transcranial random noise stimulation is more effective than transcranial direct current stimulation for enhancing working memory in healthy individuals: Behavioural and electrophysiological evidence.,"BACKGROUND


Transcranial direct current stimulation (tDCS) has been shown to improve working memory (WM) performance in healthy individuals, however effects tend to be modest and variable. Transcranial random noise stimulation (tRNS) can be delivered with a direct-current offset (DC-offset) to induce equal or even greater effects on cortical excitability than tDCS. To-date, no research has directly compared the effects of these techniques on WM performance or underlying neurophysiological activity.
OBJECTIVE


To compare the effects of anodal tDCS, tRNS + DC-offset, or sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) on WM performance and task-related EEG oscillatory activity in healthy adults.
METHODS


Using a between-subjects design, 49 participants were allocated to receive either anodal tDCS (N = 16), high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC. Changes in WM performance were assessed using the Sternberg WM task completed before and 5- and 25-min post-stimulation. Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity was analysed from EEG recorded during WM encoding and maintenance.
RESULTS


tRNS induced more pronounced and consistent enhancements in WM accuracy when compared to both tDCS and sham stimulation. Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
CONCLUSIONS


These findings demonstrate the potential of tRNS + DC-offset to modulate cognitive and electrophysiological measures of WM and raise the possibility that tRNS + DC-offset may be more effective and reliable than tDCS for enhancing WM performance in healthy individuals.",2020,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","['49 participants', 'healthy individuals', 'healthy adults', 'Healthy Individuals']","['Transcranial direct current stimulation (tDCS', 'high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC', 'anodal tDCS', 'tDCS', 'Transcranial random noise stimulation (tRNS', 'Transcranial Direct Current Stimulation', 'Transcranial Random Noise Stimulation', 'anodal tDCS, tRNS + DC-offset, or sham stimulation']","['WM performance and task-related EEG oscillatory activity', 'Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity', 'Changes in WM performance', 'working memory (WM) performance', 'WM accuracy', 'theta ERS and diminished gamma ERD', 'WM performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",49.0,0.0357647,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","[{'ForeName': 'O W', 'Initials': 'OW', 'LastName': 'Murphy', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Central Clinical School, The Alfred and Monash University, Melbourne, Australia; Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: oscar.murphy@monash.edu.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: kate.hoy@monash.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia. Electronic address: d.wong@latrobe.edu.au.'}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Bailey', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: neil.bailey@monash.edu.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: paul.fitzgerald@monash.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Segrave', 'Affiliation': 'Brain and Mental Health Research Hub, School of Psychological Sciences and Monash Biomedical Imaging, Monash Institute of Cognitive and Clinical Neuroscience, Monash University, Clayton, Australia. Electronic address: rebecca.segrave@monash.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.07.001']
1517,32659483,Non-invasive vagal nerve stimulation decreases brain activity during trauma scripts.,"BACKGROUND


Traumatic stress can have lasting effects on neurobiology and result in psychiatric conditions such as posttraumatic stress disorder (PTSD). We hypothesize that non-invasive cervical vagal nerve stimulation (nVNS) may alleviate trauma symptoms by reducing stress sympathetic reactivity. This study examined how nVNS alters neural responses to personalized traumatic scripts.
METHODS


Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study. In three sequential time blocks, personalized traumatic scripts were presented to participants immediately followed by either sham stimulation (n = 8; 0-14 V, 0.2 Hz, pulse width = 5s) or active nVNS (n = 11; 0-30 V, 25 Hz, pulse width = 40 ms). Brain activity during traumatic scripts was assessed using High Resolution Positron Emission Tomography (HR-PET) with radiolabeled water to measure brain blood flow.
RESULTS


Traumatic scripts resulted in significant activations within the bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen. Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate. During the first exposure to the trauma scripts, greater activations were found in the motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations were more predominant with later script presentations for those subjects receiving sham stimulation.
CONCLUSION


nVNS decreases neural reactivity to an emotional stressor in limbic and other brain areas involved in stress, with changes over repeated exposures suggesting a shift from scene appraisal to cognitively processing the emotional event.",2020,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.",['Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study'],"['invasive cervical vagal nerve stimulation (nVNS', 'active nVNS', 'nVNS']","['bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen', 'motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations', 'Greater activation', 'Brain activity']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",19.0,0.0708328,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: mattwittbrodt@emory.edu.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Minxuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Pearce', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Zuhayr S', 'Initials': 'ZS', 'LastName': 'Alam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Rapaport', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Murrah', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ammer A', 'Initials': 'AA', 'LastName': 'Haffer', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Shallenberger', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA; Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.002']
1518,32660977,"Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52.","OBJECTIVES


SPIRIT head-to-head (H2H) is a 52-week (Wk) trial comparing ixekizumab (IXE) with adalimumab (ADA) for simultaneous American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 responses in 566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA). IXE was superior to ADA for this primary end point at Wk24. We aimed to determine the final efficacy and safety results through Wk52 including a prespecified subgroup analysis of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use.
METHODS


SPIRIT-H2H is a Wk52 multicentre, open-label, blinded-assessor study comparing IXE and ADA in bionaïve patients with PsA. Patients were randomised 1:1 to IXE or ADA with stratification by concomitant csDMARD use and presence of moderate-to-severe plaque psoriasis. Prespecified end points at Wk24 and Wk52 included musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety.
RESULTS


A significantly higher proportion of patients treated with IXE versus ADA simultaneously achieved ACR50 and PASI100 (39% vs 26%, p<0.001), PASI100 (64% vs 41%, p<0.001) at Wk52. Efficacy of IXE and ADA was similar at Wk52 for ACR50 (49.8% vs 49.8%, p=0.924), treat-to-target outcomes, enthesitis and dactylitis resolution. Responses to IXE were consistent irrespective of concomitant csDMARD use. Significantly more patients on IXE monotherapy versus ADA monotherapy had simultaneous ACR50 and PASI100 (38% vs 19%, p=0.007), and PASI100 responses (66% vs 35%, p<0.001) at Wk52. There were no new safety findings for IXE or ADA.
CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations. IXE efficacy was consistent irrespective of concomitant csDMARD use.
TRIAL REGISTRATION NUMBER


NCT03151551.",2020,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","['566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA', 'bionaïve patients with PsA. Patients', 'patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug']","['IXE or ADA', 'conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD', 'IXE', 'ixekizumab (IXE) with adalimumab (ADA', 'ixekizumab versus adalimumab', 'IXE and ADA']","['simultaneous ACR50 and PASI100', 'musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety', 'simultaneous joint and skin improvement', 'IXE efficacy', 'PASI100 responses', 'efficacy and safety', 'ACR50 and PASI100']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0954263,"CONCLUSIONS


IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria josef.smolen@meduniwien.ac.at.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Providence St Joseph Health, Rentton, Washington, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'de la Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lingnan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Hojnik', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sapin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': ""Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Caporali', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan, G. Pini Hospital, Milan, Lombardia, Italy.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Rheumatology Department, Hospital Universitario Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goupille', 'Affiliation': 'Department of Rheumatology, Regional University Hospital Centre Tours, Tours, Centre, France.'}, {'ForeName': 'Soyi', 'Initials': 'S', 'LastName': 'Liu Leage', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sreekumar', 'Initials': 'S', 'LastName': 'Pillai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Griffith University School of Medicine, Gold Coast, Queensland, Australia.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217372']
1519,32665059,"Individualised positive end-expiratory pressure guided by electrical impedance tomography for robot-assisted laparoscopic radical prostatectomy: a prospective, randomised controlled clinical trial.","BACKGROUND


Robot-assisted laparoscopic radical prostatectomy requires general anaesthesia, extreme Trendelenburg positioning and capnoperitoneum. Together these promote impaired pulmonary gas exchange caused by atelectasis and may contribute to postoperative pulmonary complications. In morbidly obese patients, a recruitment manoeuvre (RM) followed by individualised PEEP improves intraoperative oxygenation and end-expiratory lung volume (EELV). We hypothesised that individualised PEEP with initial RM similarly improves intraoperative oxygenation and EELV in non-obese individuals undergoing robot-assisted prostatectomy.
METHODS


Forty males (age, 49-76 yr; BMI <30 kg m -2 ) undergoing prostatectomy received volume-controlled ventilation (tidal volume 8 ml kg -1  predicted body weight). Participants were randomised to either (1) RM followed by individualised PEEP (RM/PEEP IND ) optimised using electrical impedance tomography or (2) no RM with 5 cm H 2 O PEEP. The primary outcome was the ratio of arterial oxygen partial pressure to fractional inspired oxygen (Pao 2 /F i o 2 ) before the last RM before extubation. Secondary outcomes included regional ventilation distribution and EELV which were measured before, during, and after anaesthesia. The cardiovascular effects of RM/PEEP IND  were also assessed.
RESULTS


In 20 males randomised to RM/PEEP IND , the median PEEP IND  was 14 cm H 2 O [inter-quartile range, 8-20]. The Pao 2 /F i o 2  was 10.0 kPa higher with RM/PEEP IND  before extubation (95% confidence interval [CI], 2.6-17.3 kPa; P=0.001). RM/PEEP IND  increased end-expiratory lung volume by 1.49 L (95% CI, 1.09-1.89 L; P<0.001). RM/PEEP IND  also improved the regional ventilation of dependent lung regions. Vasopressor and fluid therapy was similar between groups, although 13 patients randomised to RM/PEEP IND  required pharmacological therapy for bradycardia.
CONCLUSION


In non-obese males, an individualised ventilation strategy improved intraoperative oxygenation, which was associated with higher end-expiratory lung volumes during robot-assisted laparoscopic prostatectomy.
CLINICAL TRIAL REGISTRATION


DRKS00004199 (German clinical trials registry).",2020,"i o 2  was 10.0 kPa higher with RM/PEEP IND  before extubation (95% confidence interval [CI], 2.6-17.3 kPa; P=0.001).","['morbidly obese patients', 'Forty males (age, 49-76 yr', '20 males randomised to', 'non-obese individuals undergoing robot-assisted prostatectomy']","['RM followed by individualised PEEP (RM/PEEP IND ) optimised using electrical impedance tomography or (2) no RM with 5 cm H', 'Individualised positive end-expiratory pressure guided by electrical impedance tomography for robot-assisted laparoscopic radical prostatectomy', 'F', 'Robot-assisted laparoscopic radical prostatectomy', 'RM/PEEP IND', 'Vasopressor and fluid therapy']","['ratio of arterial oxygen partial pressure to fractional inspired oxygen (Pao 2', 'intraoperative oxygenation', 'intraoperative oxygenation and end-expiratory lung volume (EELV', 'regional ventilation distribution and EELV', 'regional ventilation of dependent lung regions', 'intraoperative oxygenation and EELV', 'RM/PEEP IND  increased end-expiratory lung volume']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.551583,"i o 2  was 10.0 kPa higher with RM/PEEP IND  before extubation (95% confidence interval [CI], 2.6-17.3 kPa; P=0.001).","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Girrbach', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany; Innovation Centre Computer Assisted Surgery, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': 'Clinical Trial Centre, University of Leipzig, Leipzig, Germany; Integrated Research and Treatment Centre (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Lange', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Klotz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Scherz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Giannella-Neto', 'Affiliation': 'Laboratory of Pulmonary Engineering, Biomedical Engineering Program, Alberto Luis Coimbra Institute of Post-Graduation and Research in Engineering, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Beda', 'Affiliation': 'Department of Electronic Engineering, BioSiX-Biomedical Signal Processing, Analysis and Simulation Group, Postgraduate Program of Electrical Engineering (PPGEE), Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Alcendino', 'Initials': 'A', 'LastName': 'Jardim-Neto', 'Affiliation': 'Laboratory of Pulmonary Engineering, Biomedical Engineering Program, Alberto Luis Coimbra Institute of Post-Graduation and Research in Engineering, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; Department of Electronic Engineering, BioSiX-Biomedical Signal Processing, Analysis and Simulation Group, Postgraduate Program of Electrical Engineering (PPGEE), Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Jens-Uwe', 'Initials': 'JU', 'LastName': 'Stolzenburg', 'Affiliation': 'Department of Urology, University of Leipzig Medical Centre, Leipzig, Germany.'}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Reske', 'Affiliation': 'Innovation Centre Computer Assisted Surgery, University of Leipzig, Leipzig, Germany; Department of Anaesthesiology, Intensive Care and Emergency Medicine, Pain Therapy, Heinrich-Braun-Hospital, Zwickau, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Wrigge', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Emergency Medicine, Pain Therapy, Bergmannstrost Hospital Halle, Halle, Germany; Integrated Research and Treatment Centre (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Leipzig Medical Centre, Leipzig, Germany; Integrated Research and Treatment Centre (IFB) Adiposity Diseases, University of Leipzig, Leipzig, Germany. Electronic address: arbeit.simon@gmail.com.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.041']
1520,32666402,Associations between commonly used patient-reported outcome tools in postpartum depression clinical practice and the Hamilton Rating Scale for Depression.,"The objective of this study is to explore the associations between the patient-reported Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17) in order to facilitate clinical decision-making. An integrated efficacy dataset of three randomized placebo-controlled trials (NCT02614547, NCT02942004, and NCT02942017) evaluating brexanolone injection, a neuroactive steroid chemically identical to allopregnanolone, in women with postpartum depression was used for this post hoc analysis. Data were pooled across treatment arms. Associations were assessed at day 30 (end-of-trial follow-up). Pearson correlation assessed the relationship between EPDS and PHQ-9 item and total scores and HAMD-17 total score. Cohen's kappa assessed agreement of EPDS remission (score < 10) and PHQ-9 remission (score < 5) with HAMD-17 remission (score ≤ 7). Ordinary least squares (OLS) regression models were used to develop equations estimating HAMD-17 total scores from EPDS and PHQ-9 scores, respectively. The total scores showed large correlations (HAMD-17/EPDS: r = 0.71, p < 0.001; HAMD-17/PHQ-9: r = 0.75, p < 0.001). Individual EPDS and PHQ-9 items significantly correlated (r= 0.35 to 0.67, all p < 0.001) with HAMD-17 total score. EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%. OLS models yielded the following equations: HAMD-17 total = 2.66 + (EPDS total × 0.87) and HAMD-17 total = 3.99 + (PHQ-9 total × 0.97). There were large and statistically significant associations between patient-reported outcomes (EPDS, PHQ-9) and clinician-reported outcomes (HAMD-17) as clinical improvements were associated with patient-reported symptom improvement. These results provide tools to help translate clinical trial data to clinical practice, thus aiding shared decision-making for this critical population.",2020,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,['women with postpartum depression'],"['brexanolone injection', 'placebo']","['PHQ-9 remission', 'Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17', 'EPDS and PHQ-9 item and total scores and HAMD-17 total score', 'EPDS remission', 'Hamilton Rating Scale for Depression', 'Individual EPDS and PHQ-9 items']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]","[{'cui': 'C4765158', 'cui_str': 'brexanolone Injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0698929,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,"[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Gerbasi', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Eldar-Lissai', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Acaster', 'Affiliation': 'Acaster Lloyd Consulting Ltd., London, UK.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Fridman', 'Affiliation': 'AMF Consulting, Los Angeles, CA, USA.'}, {'ForeName': 'Vijayveer', 'Initials': 'V', 'LastName': 'Bonthapally', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodgkins', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kanes', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina School of Medicine, 101 Manning Drive, Chapel Hill, NC, 27514, USA. samantha_meltzer-brody@med.unc.edu.'}]",Archives of women's mental health,['10.1007/s00737-020-01042-y']
1521,32664046,Final results from a randomized phase 3 study of FOLFIRI ± panitumumab for second-line treatment of metastatic colorectal cancer.,,2014,,['metastatic colorectal cancer'],['FOLFIRI ± panitumumab'],[],"[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}]",[],,0.0213531,,[],Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu002']
1522,32671664,"An Investigation of the Skin Barrier Restoring Effects of a Cream and Lotion Containing Ceramides in a Multi-vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The RESTORE Study Phase 1.","INTRODUCTION


The replenishment of skin lipids depleted in the dry skin state is a desirable therapeutic target to restore skin moisturization; however, there is limited evidence demonstrating the success of this approach through the use of topical emollients. The purpose of this study was to provide evidence of the benefits of a cream and equivalent lotion containing skin lipids in a multi-vesicular emulsion for the management of dry skin. The hypothesis was that the test cream and test lotion could sustain skin moisturization for longer than traditional emollients by sustainably delivering skin lipids.
METHODS


A double-blind intra-subject vehicle-controlled single open-application test on the lower legs in people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted. There were six treatment sites, three per lower leg in each participant, which were treated with the test cream, the test lotion, three reference creams commonly prescribed in the UK and no treatment as a control. After baseline measurements of skin hydration, 100 μl of the test/reference creams was applied to each of the relevant treatment sites (random site allocation). Following treatment, measurements of skin hydration and scoring of visual dryness was conducted at timed intervals (3, 6, 12 and 24 h post-product application).
RESULTS


The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site. Compared to three reference emollient creams the test cream and test lotion were the only products capable of sustaining clinically meaningful improvements in skin moisturization for 24 h.
CONCLUSION


The sustained moisturization imparted by the test products reduces the need for frequent emollient application, often requiring 3-4 applications per day for traditional emollients, and should reduce the high burden of managing dry skin conditions like atopic dermatitis.",2020,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"['People with Dry, Eczema-Prone, Skin', 'people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted', 'dry skin']","['cream and equivalent lotion containing skin lipids', 'Cream and Lotion Containing Ceramides', 'double-blind intra-subject vehicle-controlled single open-application test']","['skin hydration and scoring of visual dryness', 'skin hydration and reduced skin dryness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]",,0.0643835,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"[{'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Danby', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK. s.danby@sheffield.ac.uk.'}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'Andrew', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chittock', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Kay', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}]",Dermatology and therapy,['10.1007/s13555-020-00426-3']
1523,32671684,"Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials.","INTRODUCTION


The efficacy of tiotropium/olodaterol compared with tiotropium in patients with chronic obstructive pulmonary disease (COPD) has been demonstrated in a large clinical programme. Currently, randomised controlled trial (RCT) data on dual bronchodilation as first-line maintenance therapy are limited. In this post hoc analysis of pooled data from four RCTs, we compared the efficacy of tiotropium/olodaterol versus tiotropium as maintenance therapy in patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry.
METHODS


TONADO ®  1/2 (52 weeks) and OTEMTO ®  1/2 (12 weeks) were phase III RCTs in patients with COPD. TONADO 1/2 and OTEMTO 1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) < 80% predicted (lower limit FEV 1  ≥ 30% in OTEMTO 1/2 only). We examined the effect of tiotropium/olodaterol 5/5 µg versus tiotropium 5 µg on trough FEV 1  response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score at 12 weeks in four pooled studies.
RESULTS


The pooled analysis included 1078 maintenance-naïve patients. There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12. For patients receiving tiotropium/olodaterol, the odds of achieving a minimal clinically important difference from baseline in any of the analysed outcomes (FEV 1  ≥ 0.1 L, SGRQ ≥ 4.0 points or TDI ≥ 1.0 point) were higher versus tiotropium.
CONCLUSIONS


In patients who were maintenance naïve at baseline, treatment initiation with tiotropium/olodaterol resulted in greater improvements in lung function, health status and dyspnoea severity compared with tiotropium alone, without compromising patient safety. These results support the use of dual bronchodilation with tiotropium/olodaterol as first-line maintenance treatment in patients with COPD.
TRIAL REGISTRATION


ClinicalTrials.gov: TONADO ®  1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011) and OTEMTO ®  1 and 2 (NCT01964352 and NCT02006732, registered 14 October 2013).",2020,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","['1078 maintenance-naïve patients', 'patients with COPD', '1/2 enrolled patients with post-bronchodilator forced expiratory volume in 1\xa0s (FEV 1 )\u2009<\u200980% predicted (lower limit FEV 1 \u2009≥\u200930% in OTEMTO\xa01/2 only', 'patients with COPD who were not receiving maintenance treatment with long-acting muscarinic antagonists (LAMAs), long-acting β 2 -agonists (LABAs) or inhaled corticosteroids (ICS) (""maintenance naïve"") at study entry', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD']","['tiotropium/olodaterol\xa05/5\xa0µg versus tiotropium', 'ICS', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['lung function, health status and dyspnoea severity', 'SGRQ score', 'TDI score', ""trough FEV 1  response, St. George's Respiratory Questionnaire (SGRQ) total score and Transition Dyspnoea Index (TDI) focal score""]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",,0.220967,"There were significant improvements with tiotropium/olodaterol versus tiotropium in trough FEV 1  [0.056 L; 95% confidence interval (CI) 0.033, 0.079; P < 0.0001], SGRQ score (- 1.780; 95% CI - 3.126 to - 0.434; P = 0.0096) and TDI score (0.409; 95% CI 0.077, 0.741; P = 0.0158) at week 12.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg Universitat Mainz, Mainz, Germany. Roland.Buhl@unimedizin-mainz.de.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}]",Advances in therapy,['10.1007/s12325-020-01411-0']
1524,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1525,32673215,Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial.,"BACKGROUND


Harnessing supportive influences in close relationships is an innovative and potentially effective strategy to improve sun protection behaviors.
OBJECTIVE


This pilot randomized controlled clinical trial evaluates the feasibility and impact of Sun Safe Partners Online, a web-based, couples-focused intervention to improve sun protection behavior.
METHODS


A total of 75 couples reporting suboptimal levels of sun protection recruited from Facebook advertisements were randomized to receive a web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention. Sun Safe Partners Online had 4 individual-focused modules and 4 couples-focused modules. Feasibility was assessed by study enrollment, engagement, follow-up survey completion, and intervention evaluation. Participants completed baseline and a 1-month postintervention survey assessing sun protection and exposure, along with individual and relationship attitudes about the importance of sun protection.
RESULTS


Using Facebook as a recruitment strategy resulted in rapid enrollment and higher acceptance than for the prior telephone and print trial. The follow-up survey completion was higher in the Generic Online condition (100%) than in the Sun Safe Partners Online condition (87.2%). Engagement in Sun Safe Partners Online was high, with more than two-thirds of participants completing all modules. Evaluations of Sun Safe Partners Online content and features as well as ease of navigation were excellent. Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
CONCLUSIONS


This study uses a novel approach to facilitate engagement in sun protection by harnessing the influence of relationships among spouses and cohabiting partners. A couples-focused intervention may hold promise as a means to improve sun protection behaviors beyond interventions focused solely on individuals by leveraging the concern, collaboration, and support among intimate partners and addressing relationship-based barriers to sun protection.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04549675; https://clinicaltrials.gov/ct2/show/NCT04549675.",2020,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","['Sun Safe Partners Online', 'spouses and co-habiting partners', 'Seventy five couples reporting suboptimal levels of sun protection recruited from Facebook advertisements']","['web-based intervention called Sun Safe Partners Online or a Generic Online Sun Safety Information intervention', 'Sun Safe Partners Online, an online, couple-focused intervention']",[],"[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]",[],75.0,0.170333,"Sun Safe Partners Online showed small effects on sun protection behaviors and sun exposure on weekends compared with the Generic Online intervention and moderate effect size increases in the Sun Safe Partners Online condition.
","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Manne', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Devine', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Heckman', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Frederick', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mitarotondo', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, United States.'}]",Journal of medical Internet research,['10.2196/18037']
1526,32660748,Concomitant Antibiotic Use and Survival in Urothelial Carcinoma Treated with Atezolizumab.,"Antibiotic effects on the gut microbiota may negatively impact survival with immune checkpoint inhibitors (ICIs). However, there is minimal evidence regarding whether antibiotic impacts are specific to ICIs or impacts in urothelial carcinoma (UC). In a post hoc analysis of IMvigor210 (single-arm atezolizumab) and IMvigor211 (phase III randomised trial of atezolizumab vs chemotherapy), the association between antibiotic use and overall survival (OS) and progression-free survival (PFS) was assessed via Cox proportional hazard analysis. Antibiotic use was defined as any antibiotic administration between 30 d prior to and 30 d after treatment initiation. Antibiotic use was associated with worse OS (n = 847, hazard ratio or HR [95% confidence interval {CI}] = 1.44 [1.19-1.73]) and PFS (1.24 [1.05-1.46]) with atezolizumab, but not chemotherapy (n = 415, 1.15 [0.91-1.46] and 1.09 [0.88-1.36], respectively). In the randomised cohort of IMvigor211, the OS treatment effect (HR [95% CI]) of atezolizumab versus chemotherapy was 0.95 (95% CI 0.71-1.25) for antibiotic users, compared with 0.73 (0.60-0.88) for nonusers (p[interaction] = 0.1). Similar associations were noted in the PD-L1 IC2/3 population. In conclusion, antibiotic use was associated with worse survival outcomes in UC patients treated with atezolizumab. The study does not justify a change in antibiotic selection for infections; however antibiotic overuse occurs in cancer care and this needs to be evaluated for ICIs. PATIENT SUMMARY: In this report from clinical trials IMvigor210 and IMvigor211, it was demonstrated that antibiotic use is consistently associated with worse survival in patients with urothelial carcinoma treated with atezolizumab. No antibiotic association was observed in patients treated with chemotherapy, suggesting that antibiotics may specifically reduce the effectiveness of cancer immunotherapies. Future research will continue to explore the effect of antibiotics on other immune checkpoint inhibitors and confirm whether immune checkpoint inhibitors remain the treatment of choice in cancer patients requiring antibiotics.",2020,"Antibiotic use was associated with worse OS (n = 847, hazard ratio or HR","['patients with urothelial carcinoma treated with', 'cancer patients requiring antibiotics']","['atezolizumab', 'atezolizumab vs chemotherapy', 'IMvigor210 (single-arm atezolizumab) and IMvigor211', 'Atezolizumab']","['PFS', 'hazard ratio or HR', 'antibiotic use and overall survival (OS) and progression-free survival (PFS', 'effectiveness of cancer immunotherapies', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0278348', 'cui_str': 'Immunotherapy for cancer'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.398125,"Antibiotic use was associated with worse OS (n = 847, hazard ratio or HR","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia. Electronic address: ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia; Department of Medical Oncology, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia; Department of Medical Oncology, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",European urology,['10.1016/j.eururo.2020.06.061']
1527,32667155,Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting: The iMODIPONV Randomized Controlled Trial.,"BACKGROUND


Suboptimal tissue perfusion and oxygenation during surgery may be responsible for postoperative nausea and vomiting in some patients. This trial tested the hypothesis that muscular tissue oxygen saturation-guided intraoperative care reduces postoperative nausea and vomiting.
METHODS


This multicenter, pragmatic, patient- and assessor-blinded randomized controlled (1:1 ratio) trial was conducted from September 2018 to June 2019 at six teaching hospitals in four different cities in China. Nonsmoking women, 18 to 65 yr old, and having elective laparoscopic surgery involving hysterectomy (n = 800) were randomly assigned to receive either intraoperative muscular tissue oxygen saturation-guided care or usual care. The goal was to maintain muscular tissue oxygen saturation, measured at flank and on forearm, greater than baseline or 70%, whichever was higher. The primary outcome was 24-h postoperative nausea and vomiting. Secondary outcomes included nausea severity, quality of recovery, and 30-day morbidity and mortality.
RESULTS


Of the 800 randomized patients (median age, 50 yr [range, 27 to 65]), 799 were assessed for the primary outcome. The below-goal muscular tissue oxygen saturation area under the curve was significantly smaller in patients receiving muscular tissue oxygen saturation-guided care (n = 400) than in those receiving usual care (n = 399; flank, 50 vs. 140% · min, P < 0.001; forearm, 53 vs. 245% · min, P < 0.001). The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251). There were no significant between-group differences for secondary outcomes. No harm was observed throughout the study.
CONCLUSIONS


In a relatively young and healthy female patient population, personalized, goal-directed, muscular tissue oxygen saturation-guided intraoperative care is effective in treating decreased muscular tissue oxygen saturation but does not reduce the incidence of 24-h posthysterectomy nausea and vomiting.",2020,"The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251).","['September 2018 to June 2019 at six teaching hospitals in four different cities in China', 'Nonsmoking women, 18 to 65 yr old, and having elective laparoscopic surgery involving hysterectomy (n = 800', '800 randomized patients (median age, 50 yr [range, 27 to 65']","['muscular tissue oxygen saturation-guided intraoperative care', 'intraoperative muscular tissue oxygen saturation-guided care or usual care']","['postoperative nausea and vomiting', '24-h postoperative nausea and vomiting', 'nausea severity, quality of recovery, and 30-day morbidity and mortality', 'Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting', 'incidences of 24-h postoperative nausea and vomiting', 'muscular tissue oxygen saturation']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021889', 'cui_str': 'Intraoperative care'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",800.0,0.311572,"The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, Peking University Third Hospital, Beijing, China (G.L., X.G.) the Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China (D.-D.T., Y.-Q.A., J.-J.Y.) the Department of Anesthesiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong Province, China (X.W., M.Z.) the Department of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China (X.F., Y.L.) the Department of Anesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China (W.Z., M.X., X.C.) the Department of Anesthesiology, Peking University First Hospital, Beijing, China (J.B., D.-X.W., D.-L.M.) the Department of Biostatistics, Yale University School of Public Health, Yale Center for Analytical Sciences, New Haven, Connecticut (F.D.) the Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut (X.Z., D.Y., L.M.).'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Ai', 'Affiliation': ''}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Dai', 'Affiliation': ''}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Che', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yanez', 'Affiliation': ''}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Lingzhong', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003305']
1528,32663638,"Better off at home? Effects of nursing home eligibility on costs, hospitalizations and survival.","Encouraging and helping elderly to postpone a nursing home admission appears to be a win-win that keeps long-term care spending in check and is in line with the target population's preferences, but there is little evidence about its effects. We study the causal impact of nursing home admission eligibility using Dutch administrative data and exploiting variation between randomly assigned assessors in their tendency to grant eligibility for a nursing home admission. We find a drop in medical care use when eligibility is granted, especially in hospital admissions, while total healthcare spending is unaffected. This suggests that postponing an admission may not always be a win-win after all.",2020,"We find a drop in medical care use when eligibility is granted, especially in hospital admissions, while total healthcare spending is unaffected.",[],[],"['costs, hospitalizations and survival']",[],[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0493303,"We find a drop in medical care use when eligibility is granted, especially in hospital admissions, while total healthcare spending is unaffected.","[{'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Bakx', 'Affiliation': 'Erasmus School of Health Policy and Management, the Netherlands; Network for Studies on Pensions, Ageing and Retirement, the Netherlands. Electronic address: bakx@eshpm.eur.nl.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Wouterse', 'Affiliation': 'Erasmus School of Health Policy and Management, the Netherlands; Network for Studies on Pensions, Ageing and Retirement, the Netherlands.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'van Doorslaer', 'Affiliation': 'Erasmus School of Health Policy and Management, the Netherlands; Network for Studies on Pensions, Ageing and Retirement, the Netherlands; Erasmus School of Economics, Erasmus University Rotterdam, the Netherlands; Tinbergen Institute, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Network for Studies on Pensions, Ageing and Retirement, the Netherlands; RIVM National Institute for Public Health and the Environment, the Netherlands.'}]",Journal of health economics,['10.1016/j.jhealeco.2020.102354']
1529,32669717,Investigation of the safety and feasibility of AAV1/SERCA2a gene transfer in patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL.,"The SERCA-LVAD trial was a phase 2a trial assessing the safety and feasibility of delivering an adeno-associated vector 1 carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a) to adult chronic heart failure patients implanted with a left ventricular assist device. The SERCA-LVAD trial was one of a program of AAV1/SERCA2a cardiac gene therapy trials including CUPID1, CUPID 2 and AGENT trials. Enroled subjects were randomised to receive a single intracoronary infusion of 1 × 10 13  DNase-resistant AAV1/SERCA2a particles or a placebo solution in a double-blinded design, stratified by presence of neutralising antibodies to AAV. Elective endomyocardial biopsy was performed at 6 months unless the subject had undergone cardiac transplantation, with myocardial samples assessed for the presence of exogenous viral DNA from the treatment vector. Safety assessments including ELISPOT were serially performed. Although designed as a 24 subject trial, recruitment was stopped after five subjects had been randomised and received infusion due to the neutral result from the CUPID 2 trial. Here we describe the results from the 5 patients at 3 years follow up, which confirmed that viral DNA was delivered to the failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation. Absolute levels of detectable transgene DNA were low, and no functional benefit was observed. There were no safety concerns in this small cohort. This trial identified some of the challenges of performing gene therapy trials in this LVAD patient cohort which may help guide future trial design.",2020,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","['adult chronic heart failure patients implanted with a left ventricular assist device', 'patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL']","['Elective endomyocardial biopsy', 'sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a', 'single intracoronary infusion of 1\u2009×\u200910 13  DNase-resistant AAV1/SERCA2a particles or a placebo solution', 'AAV1/SERCA2a gene transfer', 'failing human heart in 2 patients receiving gene therapy with vector detectable at follow up endomyocardial biopsy or cardiac transplantation']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0189785', 'cui_str': 'Endomyocardial biopsy'}, {'cui': 'C0916181', 'cui_str': 'Calcium-Transporting ATPases, Sarcoplasmic Reticulum'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0011519', 'cui_str': 'Deoxyribonuclease I'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}]",[],,0.220029,"Absolute levels of detectable transgene DNA were low, and no functional benefit was observed.","[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK. a.lyon@imperial.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Babalis', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Morley-Smith', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedger', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Suarez Barrientos', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Foldes', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Couch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Chowdhury', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Tzortzis', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Peters', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rog-Zielinska', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'H-Y', 'Initials': 'HY', 'LastName': 'Yang', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Welch', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Bowles', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rahman Haley', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Bell', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rice', 'Affiliation': 'Department of Histopathology, Royal Brompton and Harefield Hospitals NHS Trust, Freiburg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sasikaran', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Falaschetti', 'Affiliation': 'Imperial Clinical Trials Unit (ICTU), School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parameshwar', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tsui', 'Affiliation': 'Royal Papworth Hospital NHS Trust, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pepper', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Rudy', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Zsebo', 'Affiliation': 'Celladon Corporation, San Diego, CA, USA.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Macleod', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Terracciano', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Hajjar', 'Affiliation': 'Phospholamban Foundation, Amsterdam, Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Banner', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield Hospitals NHS Trust, London, UK.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Harding', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",Gene therapy,['10.1038/s41434-020-0171-7']
1530,32671719,Cabozantinib for the Treatment of Advanced Hepatocellular Carcinoma: Current Data and Future Perspectives.,"Cabozantinib (Cabometyx ® ) is a potent multikinase inhibitor targeting the vascular endothelial growth factor (VEGF) receptor 2, the mesenchymal-epithelial transition factor (MET) receptor, and the ""anexelekto"" (AXL) receptor tyrosine kinase. It is approved for the treatment of advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since November 2018) and in the USA (since January 2019). The approval of cabozantinib was based on results of the randomized, placebo-controlled, phase 3 CELESTIAL trial in patients with unresectable HCC, who received one or two prior lines of treatment including sorafenib. At the second planned interim analysis, the trial was stopped, because the primary end point overall survival was clearly in favor for cabozantinib. Additionally, median progression-free survival was superior to placebo. The most common ≥ grade 3 relevant adverse events in patients with HCC treated with cabozantinib were palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea. In this review, current data on cabozantinib for the treatment of patients with advanced HCC, with a focus on the management of common adverse events and ongoing clinical trials, are discussed.",2020,"Additionally, median progression-free survival was superior to placebo.","['patients with advanced HCC', 'Advanced Hepatocellular Carcinoma', 'patients with unresectable HCC, who received one or two prior lines of treatment including', 'advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since\xa0November 2018) and in the USA (since January 2019']","['Cabozantinib (Cabometyx ® ', 'sorafenib', 'Cabozantinib', 'placebo']","['palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea', 'overall survival', 'median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C4237933', 'cui_str': 'Cabometyx'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.065429,"Additionally, median progression-free survival was superior to placebo.","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Trojan', 'Affiliation': 'Universitätsklinikum Frankfurt, Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. trojan@em.uni-frankfurt.de.'}]",Drugs,['10.1007/s40265-020-01361-5']
1531,32675483,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","['79 ileocolic CD patients', ""Crohn's Disease""]",['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis'],"['SR rate', 'severe postoperative ER', 'postoperative outcomes', 'clinical recurrence (CR', 'endoscopic recurrence (ER) ', 'reduced risk of ER', 'endoscopic recurrence score and surgical recurrence rate', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'surgical recurrence (SR', 'longer time until CR']","[{'cui': 'C0450203', 'cui_str': 'Ileocolic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic'}, {'cui': 'C0332856', 'cui_str': 'Anastomosis, side to side'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",79.0,0.161354,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
1532,32675536,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2020,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'absorbable or nonabsorbable mesh repair']","['chest pain, diarrhea, and bloat symptoms', 'clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}]","[{'cui': 'C0014857', 'cui_str': 'Repair of paraesophageal diaphragmatic hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0450093', 'cui_str': 'Very large'}, {'cui': 'C0376710', 'cui_str': 'Sliding hiatus hernia'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdominal bloating'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
1533,32675537,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 7.9 (95% confidence interval: 1.0-62.4)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2020,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'One hundred twenty-two patients received', '304 patients were randomized', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution', 'simple appendicitis (SA) in children']","['placebo', 'placebo or antibiotics (Abx', 'Laparoscopic Appendicectomy', 'laparoscopic appendicectomy']","['incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation', 'WI rates', 'postoperative length of stay in a hospital', 'intra-abdominal abscess']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",304.0,0.815373,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
1534,32675541,Evidence-based Reviews in Surgery Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: Five-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial).,"QUESTION


Does surgery or conservative management of recurring diverticulitis/ongoing symptoms results in a higher quality of life (QoL) at 5-year follow-up.
DESIGN


Randomized controlled trial.
SETTING


Multicenter trial in the Netherlands.
PATIENTS


Patients aged 18 to 75 years, who presented with either ongoing abdominal complaints (for >3 months) and/or frequently recurring left-sided diverticulitis (>2 episodes in 2 years) after an objectified (via Computed Tomography, Ultrasound or Endoscopy) episode of diverticulitis were included in this study.
INTERVENTION


Elective Sigmoid Resection within 6 weeks vs. Conservative Management MAIN OUTCOME:: QoL at 5-year follow-up, as measured by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes included additional QoL assessments (including the EuroQoL-5D-3L, Visual Analogue Score for pain, and the short form 36 health survey) RESULTS:: The intention to treat analysis showed the surgical group had a higher quality of life (GIQLI) score than the conservative group (mean difference 9.7, 95% confidence interval 1.7-17.7, P = 0.018), which approached but did not meet the minimum important difference of 10. This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
CONCLUSIONS


The study results demonstrate that HRQOL at 5-year follow-up may be improved in patients undergoing surgical resection, although this difference did not meet the MID for the GIQLI.",2020,"This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
","['patients undergoing surgical resection', 'Patients aged 18 to 75 years, who presented with either ongoing abdominal complaints (for >3 months) and/or frequently recurring left-sided diverticulitis (>2 episodes in 2 years) after an objectified (via Computed Tomography, Ultrasound or Endoscopy) episode of diverticulitis were included in this study', 'Multicenter trial in the Netherlands']","['Surgery Versus Conservative Management', 'Elective Sigmoid Resection']","['Gastrointestinal Quality of Life Index (GIQLI', 'additional QoL assessments (including the EuroQoL-5D-3L, Visual Analogue Score for pain, and the short form 36 health survey', 'higher quality of life (GIQLI) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid colon structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.183572,"This difference was achieved in 67% of those in the operative group versus 57% in the conservative group (many of who eventually underwent surgery).
","[{'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': ""Department of Surgery Queen's University, Kingston, Canada.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hendren', 'Affiliation': 'Department of Surgery University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zaborowski', 'Affiliation': ""Centre for Colorectal Disease St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Des', 'Initials': 'D', 'LastName': 'Winter', 'Affiliation': ""Centre for Colorectal Disease St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000003920']
1535,32678716,Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial.,"PURPOSE


NALA (ClinicalTrials.gov identifier: NCT01808573) is a randomized, active-controlled, phase III trial comparing neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) with ≥ 2 previous HER2-directed MBC regimens.
METHODS


Patients, including those with stable, asymptomatic CNS disease, were randomly assigned 1:1 to neratinib (240 mg once every day) plus capecitabine (750 mg/m 2  twice a day 14 d/21 d) with loperamide prophylaxis, or to lapatinib (1,250 mg once every day) plus capecitabine (1,000 mg/m 2  twice a day 14 d/21 d). Coprimary end points were centrally confirmed progression-free survival (PFS) and overall survival (OS). NALA was considered positive if either primary end point was met (α split between end points). Secondary end points were time to CNS disease intervention, investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate, safety, and health-related quality of life (HRQoL).
RESULTS


A total of 621 patients from 28 countries were randomly assigned (N+C, n = 307; L+C, n = 314). Centrally reviewed PFS was improved with N+C (hazard ratio [HR], 0.76; 95% CI, 0.63 to 0.93; stratified log-rank  P = . 0059). The OS HR was 0.88 (95% CI, 0.72 to 1.07;  P = . 2098). Fewer interventions for CNS disease occurred with N+C versus L+C (cumulative incidence, 22.8%  v  29.2%;  P = . 043). ORRs were N+C 32.8% (95% CI, 27.1 to 38.9) and L+C 26.7% (95% CI, 21.5 to 32.4;  P = . 1201); median DoR was 8.5 versus 5.6 months, respectively (HR, 0.50; 95% CI, 0.33 to 0.74;  P =  .0004). The most common all-grade adverse events were diarrhea (N+C 83%  v  L+C 66%) and nausea (53%  v  42%). Discontinuation rates and HRQoL were similar between groups.
CONCLUSION


N+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.",2020,N+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.,"['Patients, including those with stable, asymptomatic CNS disease', 'HER2-Positive Metastatic Breast Cancer', 'patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) with ≥ 2 previous HER2-directed MBC regimens', '621 patients from 28 countries were randomly assigned (N+C, n = 307; L+C, n = 314']","['NALA', 'Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine', 'loperamide prophylaxis, or to lapatinib', 'capecitabine', 'N+C', 'capecitabine (L+C', 'capecitabine (N+C) against lapatinib']","['time to CNS disease intervention, investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate, safety, and health-related quality of life (HRQoL', 'progression-free survival (PFS) and overall survival (OS', 'median DoR', 'ORRs', 'Discontinuation rates and HRQoL', 'nausea', 'diarrhea ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C2713008', 'cui_str': 'neratinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",621.0,0.378684,N+C significantly improved PFS and time to intervention for CNS disease versus L+C. No new N+C safety signals were observed.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), SOLTI Breast Cancer Cooperative Group, Barcelona, Spain.""}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), SOLTI Breast Cancer Cooperative Group, Barcelona, Spain.""}, {'ForeName': 'Yin-Hsun', 'Initials': 'YH', 'LastName': 'Feng', 'Affiliation': 'Chi Mei Medical Centre, Liouying, Tainan, Taiwan and Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Shen', 'Initials': 'MS', 'LastName': 'Dai', 'Affiliation': 'Chi Mei Medical Centre, Liouying, Tainan, Taiwan and Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shang-Wen', 'Initials': 'SW', 'LastName': 'Chen', 'Affiliation': 'Chi Mei Medical Centre, Liouying, Tainan, Taiwan and Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Moy', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gradishar', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization, Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Palacova', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Trudeau', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Mattson', 'Affiliation': 'Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.'}, {'ForeName': 'Yoon Sim', 'Initials': 'YS', 'LastName': 'Yap', 'Affiliation': 'National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Ming-Feng', 'Initials': 'MF', 'LastName': 'Hou', 'Affiliation': 'Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'National Cancer Institute Fondazione Pascale, Napoli, Italy.'}, {'ForeName': 'Yu-Min', 'Initials': 'YM', 'LastName': 'Yeh', 'Affiliation': 'National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hong-Tai', 'Initials': 'HT', 'LastName': 'Chang', 'Affiliation': 'Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': 'Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wildiers', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Haley', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Fagnani', 'Affiliation': 'ASST di Vimercate, Vimercate, Italy.'}, {'ForeName': 'Yen-Shen', 'Initials': 'YS', 'LastName': 'Lu', 'Affiliation': 'National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Crown', 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Graduate School of Medicine, Gunma University, Gunma, Japan.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bebchuk', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Keyvanjah', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryce', 'Affiliation': 'Puma Biotechnology, Los Angeles, CA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': 'Magee-Womens Hospital of UPMC, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00147']
1536,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1537,32682559,Individualized PEEP to optimise respiratory mechanics during abdominal surgery: a pilot randomised controlled trial.,"BACKGROUND


Higher intraoperative driving pressures (ΔP) are associated with increased postoperative pulmonary complications (PPC). We hypothesised that dynamic adjustment of PEEP throughout abdominal surgery reduces ΔP, maintains positive end-expiratory transpulmonary pressures (P tp_ee ) and increases respiratory system static compliance (C rs ) with PEEP levels that are variable between and within patients.
METHODS


In a prospective multicentre pilot study, adults at moderate/high risk for PPC undergoing elective abdominal surgery were randomised to one of three ventilation protocols: (1) PEEP≤2 cm H 2 O, compared with periodic recruitment manoeuvres followed by individualised PEEP to either optimise respiratory system compliance (PEEP maxCrs ) or maintain positive end-expiratory transpulmonary pressure (PEEP Ptp_ee ). The composite primary outcome included intraoperative ΔP, P tp_ee , C rs , and PEEP values (median (interquartile range) and coefficients of variation [CV PEEP ]).
RESULTS


Thirty-seven patients (48.6% female; age range: 47-73 yr) were assigned to control (PEEP≤2 cm H 2 O; n=13), PEEP maxCrs  (n=16), or PEEP Ptp_ee  (n=8) groups. The PEEP Ptp_ee  intervention could not be delivered in two patients. Subjects assigned to PEEP maxCrs  had lower ΔP (median8 cm H 2 O [7-10]), compared with the control group (12 cm H 2 O [10-15]; P=0.006). PEEP maxCrs  was also associated with higher P tp_ee  (2.0 cm H 2 O [-0.7 to 4.5] vs controls: -8.3 cm H 2 O [-13.0 to -4.0]; P≤0.001) and higher C rs  (47.7 ml cm H 2 O [43.2-68.8] vs controls: 39.0 ml cm H 2 O [32.9-43.4]; P=0.009). Individualised PEEP (PEEP maxCrs  and PEEP Ptp_ee  combined) varied widely (median: 10 cm H 2 O [8-15]; CV PEEP =0.24 [0.14-0.35]), both between, and within, subjects throughout surgery.
CONCLUSIONS


This pilot study suggests that individualised PEEP management strategies applied during abdominal surgery reduce driving pressure, maintain positive P tp_ee  and increase static compliance. The wide range of PEEP observed suggests that an individualised approach is required to optimise respiratory mechanics during abdominal surgery.
CLINICAL TRIAL REGISTRATION


NCT02671721.",2020,Subjects assigned to PEEP maxCrs  had lower ΔP (median8 cm H,"['Thirty-seven patients (48.6% female; age range: 47-73 yr', 'adults at moderate/high risk for PPC undergoing elective abdominal surgery', 'abdominal surgery']","['Individualised PEEP', 'PEEP maxCrs  (n=16), or PEEP Ptp_ee', 'Individualized PEEP']","['respiratory system static compliance (C rs ) with PEEP levels', 'driving pressure, maintain positive P tp_ee  and increase static compliance', 'postoperative pulmonary complications (PPC', 'intraoperative ΔP, P tp_ee , C rs , and PEEP values (median (interquartile range) and coefficients of variation [CV PEEP ']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.272444,Subjects assigned to PEEP maxCrs  had lower ΔP (median8 cm H,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernandez-Bustamante', 'Affiliation': 'Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO, USA; Webb-Waring Center, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: Ana.Fernandez-Bustamante@cuanschutz.edu.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Sprung', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Department of Medicine, Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Bartels', 'Affiliation': 'Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Toby N', 'Initials': 'TN', 'LastName': 'Weingarten', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Kosour', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Vidal Melo', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.030']
1538,32682616,"Re: Marc-Oliver Grimm, Antione G. van der Heijden, Marc Colombel, et al. Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial ""NIMBUS"". Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.04.066.",,2020,,[],"['BCG', 'BCG Instillations']",[],[],"[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]",[],,0.0627577,,"[{'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Karabay', 'Affiliation': 'Department of Urology, University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey. Electronic address: emrekarabay@gmail.com.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Tınay', 'Affiliation': 'Department of Urology, Marmara University School of Medicine, Istanbul, Turkey.'}]",European urology,['10.1016/j.eururo.2020.06.060']
1539,32690492,ALADDIN study: does assisted hatching of vitrified/warmed blastocysts improve live birth rate? Protocol for a multicentric randomised controlled trial.,"INTRODUCTION


Recent data suggest a higher clinical pregnancy rate performing assisted hatching (AH) on previously cryopreserved embryos but fail to demonstrate significant effects on live birth rate. However, current evidence is based on studies with a small sample size and may hide a type II error. Moreover, poor attention has been given to the specific effect of AH on frozen/thawed blastocysts. To shed light on this topic, we developed the present protocol for a randomised trial to investigate the benefits of the laser-mediated partial removal of the zona pellucida in vitrified/warmed blastocysts.
METHODS AND ANALYSIS


The pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN) study is a multicentric prospective comparative study with a parallel randomised controlled design aiming to investigate whether AH performed on warmed blastocysts before embryo transfer can improve live birth rate. Women allocated to the control group will undergo embryo transfer of blastocysts not previously subjected to AH. Two infertility units will be involved in the study. Enrolment of patients will last 18 months with quarterly monitoring and the entire study is foreseen to be closed in 36 months. Secondary outcomes include: proportion of transferred blastocysts/thawed blastocyst, morphological features of blastocysts before embryo transfer, implantation, biochemical pregnancy, clinical pregnancy (ultrasound visible gestational sac), miscarriage, multiple pregnancy, preterm birth (<37 weeks of gestation), obstetrical and neonatal complications and congenital anomaly rates.
ETHICS AND DISSEMINATION


This protocol received a favourable ethical opinion from the Ethical Committee of IRCCS San Raffaele Scientific Institute and the Ethical Committee Area 2 Milan. Each participant will provide written consent to participate and remain encoded during the study. The trial results will be published in peer-reviewed journals and presented at conferences.
TRIAL REGISTRATION NUMBER


NCT03623659; Pre-results.",2020,The pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN) study is a multicentric prospective comparative study with a parallel randomised controlled design aiming to investigate whether AH performed on warmed blastocysts before embryo transfer can improve live birth rate.,[],['control group will undergo embryo transfer of blastocysts not previously subjected to AH'],"[' proportion of transferred blastocysts/thawed blastocyst, morphological features of blastocysts before embryo transfer, implantation, biochemical pregnancy, clinical pregnancy (ultrasound visible gestational sac), miscarriage, multiple pregnancy, preterm birth (<37 weeks of gestation), obstetrical and neonatal complications and congenital anomaly rates', 'live birth rate']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.229643,The pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN) study is a multicentric prospective comparative study with a parallel randomised controlled design aiming to investigate whether AH performed on warmed blastocysts before embryo transfer can improve live birth rate.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Alteri', 'Affiliation': 'Obstetrics and Gynaecology Department, IRCCS San Raffaele Scientific Institute, Milan, Italy alteri.alessandra@hsr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Guarneri', 'Affiliation': ""Infertility Unit, Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Corti', 'Affiliation': 'Obstetrics and Gynaecology Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Restelli', 'Affiliation': ""Infertility Unit, Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Reschini', 'Affiliation': ""Infertility Unit, Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giardina', 'Affiliation': 'Obstetrics and Gynaecology Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Papaleo', 'Affiliation': 'Obstetrics and Gynaecology Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Somigliana', 'Affiliation': ""Infertility Unit, Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Viganò', 'Affiliation': 'Reproductive Sciences Laboratory, Obstetrics and Gynaecology Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Paffoni', 'Affiliation': 'Infertility Unit, ASST Lariana, Cantù, Como, Italy.'}]",BMJ open,['10.1136/bmjopen-2019-031544']
1540,32690499,Randomised phase II trial of CAPTEM or FOLFIRI as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET/CT imaging and biological markers (SENECA trial): a study protocol.,"INTRODUCTION


Patients with metastatic or locally advanced, non-resectable, grade 3 poorly differentiated gastroenteropancreatic (GEP) and lung neuroendocrine carcinomas (NECs) are usually treated with in first-line platinum compounds. There is no standard second-line treatment on progression. Accurate biomarkers are needed to facilitate diagnosis and prognostic assessment of patients with NEC.
METHODS AND ANALYSIS


The SEcond-line therapy in NEuroendocrine CArcinomas (SENECA) study is a randomised, non-comparative, multicentre phase II trial designed to evaluate the efficacy and safety of folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) or capecitabine plus temozolomide (CAPTEM) regimens after failure of first-line chemotherapy in patients with lung NEC and GEP-NEC. Secondary aims are to correlate the serum miRNA profile and primary mutational status of MEN1, DAXX, ATRX and RB-1 with prognosis and outcome and to investigate the prognostic and predictive role of the Ki-67 score and 18-fluorodeoxyglucose positron emission tomography/computed tomography ( 18 F-FDG PET/CT) or  68 Ga-PET/CT. The main eligibility criteria are age ≥18 years; metastatic or locally advanced, non-resectable, grade 3 lung or GEP-NECs; progression to first-line platinum-based chemotherapy. A Bryant and Day design taking into account treatment activity and toxicity was used to estimate the sample size. All analyses will be performed separately for each treatment group in the intention-to-treat population. A total of 112 patients (56/arm) will be randomly assigned (1:1) to receive FOLFIRI every 14 days or CAPTEM every 28 days until disease progression or unacceptable toxicity or for a maximum of 6 months. Patients undergo testing for specific biomarkers in primary tumour tissue and for miRNA in blood samples. MiRNA profiling will be performed in the first 20 patients who agree to participate in the biological substudy.
ETHICS AND DISSEMINATION


The SENECA trial, supported by Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), was authorised by the locals Ethics Committee and the Italian Medicines Agency (AIFA). Results will be widely disseminated via peer-reviewed manuscripts, conference presentations and reports to relevant authorities.The study is currently open in Italy.
TRAIL REGISTRATION NUMBER


NCT03387592; Pre-results. EudraCT-2016-000767-17.
PROTOCOL VERSION


Clinical Study Protocol Version 1, 7 November 2016.",2020,"Secondary aims are to correlate the serum miRNA profile and primary mutational status of MEN1, DAXX, ATRX and RB-1 with prognosis and outcome and to investigate the prognostic and predictive role of the Ki-67 score and 18-fluorodeoxyglucose positron emission tomography/computed tomography ( 18 F-FDG PET/CT) or  68 Ga-PET/CT.","['112 patients (56/arm', 'Patients with metastatic or locally advanced, non-resectable, grade 3 poorly differentiated gastroenteropancreatic (GEP) and lung neuroendocrine carcinomas (NECs', '20 patients who agree to participate in the biological substudy', 'patients with NEC', 'The main eligibility criteria are age ≥18 years; metastatic or locally advanced, non-resectable, grade 3 lung or GEP-NECs; progression to first-line platinum-based chemotherapy', 'patients with lung NEC and GEP-NEC']","['18-fluorodeoxyglucose positron emission tomography/computed tomography ( 18 F-FDG PET/CT', 'folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) or capecitabine plus temozolomide (CAPTEM', 'Cura dei Tumori (IRST', 'Istituto Scientifico Romagnolo per lo Studio e la']","['serum miRNA profile and primary mutational status of MEN1, DAXX, ATRX and RB-1 with prognosis and outcome']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0025267', 'cui_str': 'Multiple endocrine neoplasia, type 1'}, {'cui': 'C0541030', 'cui_str': 'DAXX protein, human'}, {'cui': 'C1845055', 'cui_str': 'Alpha thalassemia X-linked intellectual disability syndrome'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",112.0,0.050486,"Secondary aims are to correlate the serum miRNA profile and primary mutational status of MEN1, DAXX, ATRX and RB-1 with prognosis and outcome and to investigate the prognostic and predictive role of the Ki-67 score and 18-fluorodeoxyglucose positron emission tomography/computed tomography ( 18 F-FDG PET/CT) or  68 Ga-PET/CT.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bongiovanni', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy alberto.bongiovanni@irst.emr.it.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Liverani', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pusceddu', 'Affiliation': 'Department of Medical Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Leo', 'Affiliation': 'Oncology Unit, Ospedale Vito Fazzi, Lecce, Puglia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Di Meglio', 'Affiliation': 'Oncology Unit, Ospedale di Bolzano, Bolzano, Trentino-Alto Adige, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamberi', 'Affiliation': 'Oncology Unit, Ospedale degli Infermi di Faenza, Faenza, Emilia-Romagna, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, Campus Bio-Medico University, Roma, Lazio, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gelsomino', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Emilia-Romagna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pucci', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Berardi', 'Affiliation': 'Oncology Clinic, University Hospital of Ancona Umberto I G M Lancisi G Salesi, Ancona, Marche, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Lolli', 'Affiliation': 'Department of Oncology, Istituto Nazionale di Ricovero e Cura a Carattere Scientifico Saverio de Bellis, Castellana Grotte, Puglia, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bergamo', 'Affiliation': 'Department of Clinical and Experimental Oncology, Istituto Oncologico Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Veneto, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'Internal Medicine and Medical Oncology, Santa Chiara Hospital, Pisa, Toscana, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Foca', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Severi', 'Affiliation': 'Nuclear Medicine Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034393']
1541,32690503,Behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement (PEP-TALK): study protocol for a pragmatic randomised controlled trial.,"INTRODUCTION


While total hip replacement (THR) and total knee replacement (TKR) successfully reduce pain associated with chronic joint pathology, this infrequently translates into increased physical activity. This is a challenge given that over 50% of individuals who undergo these operations are physically inactive and have medical comorbidities such as hypertension, heart disease, diabetes and depression. The impact of these diseases can be reduced with physical activity. This trial aims to investigate the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after THR or TKR.
METHODS AND ANALYSIS


The PEP-TALK trial is a multicentre, open-labelled, pragmatic randomised controlled trial. 260 adults who are scheduled to undergo a primary unilateral THR or TKR and are moderately inactive or inactive, with comorbidities, will be recruited across eight sites in England. They will be randomised post-surgery, prior to hospital discharge, to either six, 30 min weekly group-based exercise sessions (control), or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour approach discussion group. Participants will be followed-up to 12 months by postal questionnaire. The primary outcome is the University of California, Los Angeles (UCLA) Physical Activity Score at 12 months. Secondary outcomes include: physical function, disability, health-related quality of life, kinesiophobia, perceived pain, self-efficacy and health resource utilisation.
ETHICS AND DISSEMINATION


Research ethics committee approval was granted by the NRES Committee South Central (Oxford B - 18/SC/0423). Dissemination of results will be through peer-reviewed, scientific journals and conference presentations.
TRIAL REGISTRATION NUMBER


ISRCTN29770908.",2020,"This trial aims to investigate the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after THR or TKR.
","['260 adults who are scheduled to undergo a primary unilateral THR or TKR and are moderately inactive or inactive, with comorbidities, will be recruited across eight sites in England']","['behaviour change physiotherapy intervention', 'While total hip replacement (THR) and total knee replacement (TKR', 'Behaviour change physiotherapy intervention']","['Physical Activity Score', 'University of California, Los Angeles (UCLA', 'physical activity', 'physical function, disability, health-related quality of life, kinesiophobia, perceived pain, self-efficacy and health resource utilisation']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}]",260.0,0.138093,"This trial aims to investigate the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after THR or TKR.
","[{'ForeName': 'Toby O', 'Initials': 'TO', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK toby.smith@ndorms.ox.ac.uk.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Parsons', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Fordham', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ooms', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dutton', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hing', 'Affiliation': ""University of London St George's Molecular and Clinical Sciences Research Institute, London, UK.""}, {'ForeName': 'Vicki S', 'Initials': 'VS', 'LastName': 'Barber', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lamb', 'Affiliation': 'College of Medicine and Health Sciences, University of Exeter, Exeter, Devon, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035014']
1542,32690508,"Effect of an innovative behavioural change strategy and small-quantity lipid-based nutrient supplements on stunting and obesity in children in Baja Verapaz, Guatemala: protocol for a randomised control trial.","INTRODUCTION


In Latin America, a rapid increase in obesity alongside persistent malnutrition has resulted in a double burden of disease that affects the most vulnerable segments of the population. Infant and young child feeding practices are important factors that affect both sides of the growth curve. Interventions such as behavioural change strategies and home fortification using products like small-quantity lipid-based nutrient supplements (SQ-LNS) have the potential to reduce the presence of both these conditions, especially if they are implemented during the first 1000 days of life. This paper details the protocol for Sustained Programme for Improving Nutrition (SPOON), an innovative strategy to prevent stunting and reduce risk for obesity in children under 24 months old in high-poverty areas in Baja Verapaz, Guatemala.
METHODS AND ANALYSIS


SPOON Guatemala is a three-arm randomised control trial: treatment group 1 will receive the SPOON behavioural change strategy and SQ-LNS, treatment group 2 will receive the SPOON behavioural change strategy and micronutrient powders; the control group will receive the standard of care provided by the Ministry of Health, which includes micronutrient powders. A modified formula of SQ-LNS has been especially developed for this trial. A total of 76 communities are included in the study and 1628 households with a pregnant woman in the third trimester or a child under 4.5 months were recruited at baseline. Baseline data were collected between September and November 2018. Follow-up data will be collected 2 years after the start of the intervention. The primary outcomes of interest are related to mothers' infant feeding knowledge and practice, and indicators of children's nutritional status and growth including height, weight, weight gain rate and prevalence of stunting, overweight, obesity and anaemia. After follow-up data have been collected, differences of simple means and regression models including covariates such as child's age and sex, characteristics of the primary caregiver and household socioeconomic indicators will be estimated. Heterogeneous effects will also be estimated within subgroups of age at exposure, sex, caregiver characteristics and household socioeconomic status.
ETHICS AND DISSEMINATION


This study was approved by the National Health Ethics Committee of the Ministry of Health of Guatemala (resolution 10-2018). Informed consent was obtained from all mothers and caregivers prior to enrolment in the programme. Results will be submitted to a peer-reviewed medical or public health journal, and disseminated internally at the Inter-American Development Bank, with the Government and Stakeholders in Guatemala and through international conferences and seminars.
TRIAL REGISTRATION NUMBER


NCT03399617.",2020,"Guatemala is a three-arm randomised control trial: treatment group 1 will receive the SPOON behavioural change strategy and SQ-LNS, treatment group 2 will receive the SPOON behavioural change strategy and micronutrient powders; the control group will receive the standard of care provided by the Ministry of Health, which includes micronutrient powders.","['children under 24 months old in high-poverty areas in Baja Verapaz, Guatemala', 'A total of 76 communities are included in the study and 1628 households with a pregnant woman in the third trimester or a child under 4.5 months were recruited at baseline', 'stunting and obesity in children in Baja Verapaz, Guatemala']","['innovative behavioural change strategy and small-quantity lipid-based nutrient supplements', 'home fortification using products like small-quantity lipid-based nutrient supplements (SQ-LNS', 'SPOON behavioural change strategy and SQ-LNS, treatment group 2 will receive the SPOON behavioural change strategy and micronutrient powders; the control group will receive the standard of care provided by the Ministry of Health, which includes micronutrient powders']","[""mothers' infant feeding knowledge and practice, and indicators of children's nutritional status and growth including height, weight, weight gain rate and prevalence of stunting, overweight, obesity and anaemia""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032855', 'cui_str': 'Poverty Areas'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",1628.0,0.129446,"Guatemala is a three-arm randomised control trial: treatment group 1 will receive the SPOON behavioural change strategy and SQ-LNS, treatment group 2 will receive the SPOON behavioural change strategy and micronutrient powders; the control group will receive the standard of care provided by the Ministry of Health, which includes micronutrient powders.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'González Acero', 'Affiliation': 'Social Protection and Health Division, Inter- American Development Bank, Washington, District of Columbia, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Office of Strategic Planning and Development Effectiveness, Inter- American Development Bank, Washington, District of Columbia, USA SMARTINEZ@iadb.org.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pérez-Expósito', 'Affiliation': 'Social Protection and Health Division, Inter- American Development Bank, Washington, District of Columbia, USA.'}, {'ForeName': 'Solis', 'Initials': 'S', 'LastName': 'Winters', 'Affiliation': 'Office of Strategic Planning and Development Effectiveness, Inter- American Development Bank, Washington, District of Columbia, USA.'}]",BMJ open,['10.1136/bmjopen-2019-035528']
1543,32692705,Which technique is better to place a manoeuvrable vacuum extractor cup on the flexion point? Vacca vs. Bird technique.,"Objectives The purpose of this study is to compare the vacuum extractor cup application technique described by Bird vs. the technique described by Vacca on a simulation model. Methods Six obstetricians participated in the study. Each obstetrician performed eight vacuum assisted deliveries using the Bird technique and eight vacuum assisted deliveries using the Vacca 5-Steps technique. Results A total of 96 vacuum assisted deliveries were performed. The mean distance from the centre of the cup to the flexion point was 1.78±0.96 cm for the Bird technique and 1.05±0.60 cm for the Vacca technique (p<0.001). The lateral distance (over the parietal bone) was 1.16±0.69 cm for the Bird technique and 0.66±0.52 cm for the Vacca technique (p<0.001). The vertical distance (towards the frontal or occipital bone) was 1.12±1.02 cm for the Bird technique and 0.67±0.55 cm for the Vacca technique (p=0.009). In occipito anterior positions, there were no significant differences between both techniques. Conclusions The Vacca technique was better in transverse and posterior positions.",2020,cm for the Bird technique and 1.05 ± 0.60 cm for the Vacca technique (p<0.001).,[],"['Vacca versus Bird technique', 'vacuum extractor cup application technique']","['mean distance', 'lateral distance', 'vertical distance']",[],"[{'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1272612', 'cui_str': 'Vacuum extractor'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",6.0,0.0171587,cm for the Bird technique and 1.05 ± 0.60 cm for the Vacca technique (p<0.001).,"[{'ForeName': 'Marcos Javier', 'Initials': 'MJ', 'LastName': 'Cuerva', 'Affiliation': 'Department of Obstetrics, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Jose Ángel', 'Initials': 'JÁ', 'LastName': 'Espinosa', 'Affiliation': 'Department of Affective Childbirth (UPA), Hospital San Francisco de Asís, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Barras', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Universitario Infanta Cristina, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Gonzalez-Cerron', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Faride', 'Initials': 'F', 'LastName': 'Ojeda', 'Affiliation': 'Department of Affective Childbirth (UPA), Hospital San Francisco de Asís, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cortés', 'Affiliation': 'Department of Obstetrics, Hospital Universitario La Paz, Madrid, Spain.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0077']
1544,32692747,"Polygenic risk score for obesity and the quality, quantity, and timing of workplace food purchases: A secondary analysis from the ChooseWell 365 randomized trial.","BACKGROUND


The influence of genetic risk for obesity on food choice behaviors is unknown and may be in the causal pathway between genetic risk and weight gain. The aim of this study was to examine associations between genetic risk for obesity and food choice behaviors using objectively assessed workplace food purchases.
METHODS AND FINDINGS


This study is a secondary analysis of baseline data collected prior to the start of the ""ChooseWell 365"" health-promotion intervention randomized control trial. Participants were employees of a large hospital in Boston, MA, who enrolled in the study between September 2016 and February 2018. Cafeteria sales data, collected retrospectively for 3 months prior to enrollment, were used to track the quantity (number of items per 3 months) and timing (median time of day) of purchases, and participant surveys provided self-reported behaviors, including skipping meals and preparing meals at home. A previously validated Healthy Purchasing Score was calculated using the cafeteria traffic-light labeling system (i.e., green = healthy, yellow = less healthy, red = unhealthy) to estimate the healthfulness (quality) of employees' purchases (range, 0%-100% healthy). DNA was extracted and genotyped from blood samples. A body mass index (BMI) genome-wide polygenic score (BMIGPS) was generated by summing BMI-increasing risk alleles across the genome. Additionally, 3 polygenic risk scores (PRSs) were generated with 97 BMI variants previously identified at the genome-wide significance level (P < 5 × 10-8): (1) BMI97 (97 loci), (2) BMICNS (54 loci near genes related to central nervous system [CNS]), and (3) BMInon-CNS (43 loci not related to CNS). Multivariable linear and logistic regression tested associations of genetic risk score quartiles with workplace purchases, adjusted for age, sex, seasonality, and population structure. Associations were considered significant at P < 0.05. In 397 participants, mean age was 44.9 years, and 80.9% were female. Higher genetic risk scores were associated with higher BMI. The highest quartile of BMIGPS was associated with lower Healthy Purchasing Score (-4.8 percentage points [95% CI -8.6 to -1.0]; P = 0.02), higher quantity of food purchases (14.4 more items [95% CI -0.1 to 29.0]; P = 0.03), later time of breakfast purchases (15.0 minutes later [95% CI 1.5-28.5]; P = 0.03), and lower likelihood of preparing dinner at home (Q4 odds ratio [OR] = 0.3 [95% CI 0.1-0.9]; P = 0.03) relative to the lowest BMIGPS quartile. Compared with the lowest quartile, the highest BMICNS quartile was associated with fewer items purchased (P = 0.04), and the highest BMInon-CNS quartile was associated with purchasing breakfast at a later time (P = 0.01), skipping breakfast (P = 0.03), and not preparing breakfast (P = 0.04) or lunch (P = 0.01) at home. A limitation of this study is our data come from a relatively small sample of healthy working adults of European ancestry who volunteered to enroll in a health-promotion study, which may limit generalizability.
CONCLUSIONS


In this study, genetic risk for obesity was associated with the quality, quantity, and timing of objectively measured workplace food purchases. These findings suggest that genetic risk for obesity may influence eating behaviors that contribute to weight and could be targeted in personalized workplace wellness programs in the future.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02660086.",2020,"Compared with the lowest quartile, the highest BMICNS quartile was associated with fewer items purchased (P = 0.04), and the highest BMInon-CNS quartile was associated with purchasing breakfast at a later time (P = 0.01), skipping breakfast (P = 0.03), and not preparing breakfast (P = 0.04) or lunch (P = 0.01) at home.","['healthy working adults of European ancestry who volunteered to enroll in a health-promotion study', 'Participants were employees of a large hospital in Boston, MA, who enrolled in the study between September 2016 and February 2018', '397 participants, mean age was 44.9 years, and 80.9% were female']",[],"['higher quantity of food purchases', 'skipping breakfast', 'A body mass index (BMI) genome-wide polygenic score (BMIGPS', 'highest BMInon-CNS quartile', 'Polygenic risk score for obesity and the quality, quantity, and timing of workplace food purchases', '3 polygenic risk scores (PRSs', 'Higher genetic risk scores', 'later time of breakfast purchases', 'Healthy Purchasing Score']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.112173,"Compared with the lowest quartile, the highest BMICNS quartile was associated with fewer items purchased (P = 0.04), and the highest BMInon-CNS quartile was associated with purchasing breakfast at a later time (P = 0.01), skipping breakfast (P = 0.03), and not preparing breakfast (P = 0.04) or lunch (P = 0.01) at home.","[{'ForeName': 'Hassan S', 'Initials': 'HS', 'LastName': 'Dashti', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Mongan Institute Health Policy Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'McCurley', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Saxena', 'Affiliation': 'Center for Genomic Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003219']
1545,32687819,"Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial.","BACKGROUND


Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on health outcomes.
OBJECTIVE


This study aimed to determine whether prepregnancy weight loss reduces gestational weight gain and improves pregnancy outcomes.
STUDY DESIGN


Pragmatic randomized clinical trial was conducted between May 2015 and October 2019 at Kaiser Permanente Northwest, an integrated health system. Data collection was blind to condition assignment. Eligible participants were women aged 18 to 40 years with a body mass index of ≥27 kg/m 2  who were planning pregnancy within 2 years. Recruitment contacts were sent to 27,665 health system members who met age and body mass index criteria; 329 women attended screening visits, and 326 were randomized. They were randomized to either a behavioral weight loss intervention or usual care control. The intervention consisted of health coaching phone sessions weekly for 6 months and then monthly for 18 months or until end of pregnancy. We used logistic regression to examine the a priori primary hypothesis that participants in the intervention would be less likely to exceed National Academy of Medicine guidelines for gestational weight gain during each trimester and overall. Secondary and exploratory outcomes included absolute weight gain before and during pregnancy and perinatal and newborn outcomes.
RESULTS


Of the 326 participants, 169 had singleton pregnancies lasting ≥14 weeks (analytical cohort: intervention, 89; control, 80). At baseline, mean age was 31.3±3.5 years, and body mass index was 34.8±5.8 kg/m 2 . Participants in the intervention group lost more weight before pregnancy than those in the control group (-0.25±0.51 vs -0.03±0.21 kg/wk; P<.001). However, participants in the intervention group gained more weight than those in the control group in the second trimester (0.42±0.26 vs 0.33±0.28 kg/wk; P=.04) and third trimester (0.56±0.37 vs 0.43±0.33 kg/wk; P=.02) and overall (13.2±8.20 vs 10.3±7.41 kg; P=.03). Nevertheless, arms did not differ in rates of exceeding gestational weight gain guidelines at any time point. Spontaneous pregnancy loss was less common in the intervention arm than in the control arm (8 [4.9%] vs 19 [11.8%]; odds ratio, 0.39 [0.16-0.92]), but we found no other differences in the secondary or exploratory outcomes.
CONCLUSION


Participation in the prepregnancy weight loss intervention had no effect on women's likelihood of exceeding gestational weight gain guidelines. Although the intervention group successfully lost weight before conception, the intervention group was associated with greater weight gain in late pregnancy. To effectively reduce weight throughout pregnancy and improve maternal and child outcomes, prepregnancy weight loss interventions may need to be combined with intensive weight management that continues throughout delivery.",2020,"Intervention participants lost more weight before pregnancy than controls (-0.25±0.51 vs -0.03±0.21 kg/week, P<0.001).","['326 participants', '27,665 health system members who met age and BMI criteria; 329 women attended screening visits and 326 were randomized', '169 had singleton pregnancies lasting ≥14 weeks', 'Women with elevated body mass index', 'Eligible participants were women aged 18-40 years with BMI ≥27 kg/m 2  who were planning pregnancy within 2 years', 'May 2015 and October 2019 at Kaiser Permanente Northwest, an integrated health system']","['behavioral weight loss intervention or usual care control', 'health-coaching phone sessions']","['rates of exceeding gestational weight gain guidelines', 'weight', 'Weight Loss', 'absolute weight gain before and during pregnancy and perinatal and newborn outcomes', 'weight gain', 'weight before pregnancy', 'gestational weight gain and improves pregnancy outcomes', 'Spontaneous pregnancy loss', 'gestational weight gain']","[{'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032992', 'cui_str': 'Pregnant - planned'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}]",,0.162714,"Intervention participants lost more weight before pregnancy than controls (-0.25±0.51 vs -0.03±0.21 kg/week, P<0.001).","[{'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente, Center for Health Research, Portland, OR. Electronic address: erin.s.leblanc@kpchr.org.'}, {'ForeName': 'Ning X', 'Initials': 'NX', 'LastName': 'Smith', 'Affiliation': 'Kaiser Permanente, Center for Health Research, Portland, OR.'}, {'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Vesco', 'Affiliation': 'Kaiser Permanente, Center for Health Research, Portland, OR.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Stevens', 'Affiliation': 'Kaiser Permanente, Center for Health Research, Portland, OR.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.027']
1546,32675334,Parental Perspectives on Continuous Pulse Oximetry Use in Bronchiolitis Hospitalizations.,"BACKGROUND


Because of the impact of continuous pulse oximetry (CPOX) on the overdiagnosis of hypoxemia in bronchiolitis, the American Academy of Pediatrics and the Choosing Wisely campaign have issued recommendations for intermittent monitoring. Parental preferences for monitoring may impact adoption of these recommendations, but these perspectives are poorly understood.
METHODS


Using this cross-sectional survey, we explored parental perspectives on CPOX monitoring before discharge and 1 week after bronchiolitis hospitalizations. During the 1-week call, half of the participants were randomly assigned to receive a verbal statement on the potential harms of CPOX to determine if conveying the concept of overdiagnosis can change parental preferences on monitoring frequency. An aggregate variable measuring favorable perceptions of CPOX was created to determine CPOX affinity predictors.
RESULTS


In-hospital interviews were completed on 357 patients, of which 306 (86%) completed the 1-week follow-up. Although 25% of parents agreed or strongly agreed that hospital monitors made them feel anxious, 98% agreed that the monitors were helpful. Compared to other vital signs, respiratory rate (87%) and oxygen saturation (84%) were commonly rated as ""extremely important."" Providing an educational statement on CPOX comparatively decreased parental desire for continuous monitoring (40% vs 20%;  P  < .001). Although there were no significant predictors of CPOX affinity, the effect size of the educational intervention was higher in college-educated parents.
CONCLUSIONS


Parents find security in CPOX. A brief statement on the potential harms of CPOX use had an impact on stated monitoring preferences. Parental perspectives are important to consider because they may influence the adoption of intermittent monitoring.",2020,Providing an educational statement on CPOX comparatively decreased parental desire for continuous monitoring (40% vs 20%;  P  < .001).,['Bronchiolitis Hospitalizations'],"['continuous pulse oximetry (CPOX', 'verbal statement']","['respiratory rate', 'oxygen saturation']","[{'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1960498', 'cui_str': 'Continuous pulse oximetry'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.0345223,Providing an educational statement on CPOX comparatively decreased parental desire for continuous monitoring (40% vs 20%;  P  < .001).,"[{'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Chi', 'Affiliation': ""Division of Pediatric Hospital Medicine, Department of Pediatrics, Lucile Packard Children's Hospital Stanford and School of Medicine, Stanford University, Stanford, California; and kevinchi@stanford.edu.""}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Coon', 'Affiliation': ""Department of Pediatrics, School of Medicine, University of Utah and Primary Children's Hospital, Salt Lake City, Utah.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Destino', 'Affiliation': ""Division of Pediatric Hospital Medicine, Department of Pediatrics, Lucile Packard Children's Hospital Stanford and School of Medicine, Stanford University, Stanford, California; and.""}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Schroeder', 'Affiliation': ""Division of Pediatric Hospital Medicine, Department of Pediatrics, Lucile Packard Children's Hospital Stanford and School of Medicine, Stanford University, Stanford, California; and.""}]",Pediatrics,['10.1542/peds.2020-0130']
1547,32676833,Correction to: Does Organizing Mentor-Mentee Matches into Small Groups Enhance Treatment Effects in a Site-Based Mentoring Program for Adolescents? Results of a Randomized Controlled Trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],[],[],[],[],[],,0.0383541,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Haddock', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA. shelley.haddock@colostate.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota, St. Paul, MN, 55108, USA.'}, {'ForeName': 'Hyanghee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Toni S', 'Initials': 'TS', 'LastName': 'Zimmerman', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Krafchick', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gereon F', 'Initials': 'GF', 'LastName': 'Fredrickson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Yetz', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Youngblade', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01283-1']
1548,32673939,Individualized PEEP ventilation between tumor resection and dural suture in craniotomy.,"OBJECTIVE


Atelectasis, which affects oxygenation, is always occurred after craniotomy under general anesthesia. The commonly used protective ventilation strategy, which includes recruitment maneuver and higher level of positive end-expiratory pressure (PEEP), can effectively reduce atelectasis after heart and abdominal surgery, but increase intracranial pressure and reduce cerebral perfusion in patients undergoing craniotomy. We hypothesized individualized PEEP ventilation between tumor resection and dural suture in craniotomy could effectively reduce postoperative atelectasis, improve PaO 2 /FiO 2  ratio, and without reducing the regional cerebral oxygen saturation (rScO 2 ).
PATIENTS AND METHODS


96 patients underwent tumor craniotomy in supine position were randomized into the control group (C group) and individualized PEEP group (P group). In the C group, the tidal volume (VT) was set at 8 mL/kg of predicted body weight, but PEEP were not used. In the P group, VT was set at 6 mL/kg of predicted body weight combined with individualized PEEP between tumor resection and dural suture, while in other periods of general anesthesia, VT was set at 8 mL/kg of predicted body weight. PaO 2 /FiO 2  ratio, lung ultrasound score (LUS) and rScO 2  were measured before induction, 1 h and 24 h after extubation.
RESULTS


Individual PEEP in the P group was 7.0 (4.0-9.0). The PaO 2 /FiO 2  ratio and rScO 2  in the P group were significantly higher than that of the C group (395 ± 62 vs. 344 ± 40, 67 ± 5 vs. 61 ± 4, respectively, p < 0.05) and the LUS of the experimental group was significantly lower than that of the C group [7.5 (5.3-8.3) vs. 10.0 (9.0-12.0), p < 0.05] 1 h after extubation.
CONCLUSION


Mechanical ventilation with individualized PEEP between tumor resection and dural suture in craniotomy can reduce atelectasis, improve PaO 2 /FiO 2  ratio and rScO 2  1 h after extubation.",2020,"The PaO 2 /FiO 2  ratio and rScO 2  in the P group were significantly higher than that of the C group (395 ± 62 vs. 344 ± 40, 67 ± 5 vs. 61 ± 4, respectively, p < 0.05) and the LUS of the experimental group was significantly lower than that of the C group [7.5 (5.3-8.3) vs. 10.0 (9.0-12.0), p < 0.05] 1 h after extubation.
","['patients undergoing craniotomy', '96 patients underwent tumor craniotomy in supine position']","['control group (C group) and individualized PEEP', 'Individualized PEEP ventilation']","['PaO 2 /FiO 2  ratio, lung ultrasound score (LUS) and rScO 2', 'tidal volume (VT', 'LUS', 'regional cerebral oxygen saturation (rScO 2 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}]",96.0,0.0496743,"The PaO 2 /FiO 2  ratio and rScO 2  in the P group were significantly higher than that of the C group (395 ± 62 vs. 344 ± 40, 67 ± 5 vs. 61 ± 4, respectively, p < 0.05) and the LUS of the experimental group was significantly lower than that of the C group [7.5 (5.3-8.3) vs. 10.0 (9.0-12.0), p < 0.05] 1 h after extubation.
","[{'ForeName': 'Hairui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Jinlu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Yueqin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Mingxia', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection Control, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Peimin', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China. Electronic address: xiehong_sz@hotmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Neurosurgery, The Second Affiliated Hospital of Soochow University, 1055 Sanxiang Road, Suzhou 215004, China. Electronic address: dongjun@suda.edu.cn.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106027']
1549,32673969,A systematic review and indirect treatment comparison of perampanel versus brivaracetam as adjunctive therapy in patients with focal-onset seizures with or without secondary generalization.,"PURPOSE


To date, there has not been a single randomized controlled trial (RCT) conducted to directly compare the efficacy and safety of perampanel to brivaracetam in the adjunctive treatment of focal-onset seizures. This study makes these comparisons through the use of indirect treatment comparison (ITC) methods.
METHODS


A systematic review was conducted to identify RCTs that evaluated either one of perampanel or brivaracetam in the treatment of patients with focal-onset seizures. The Bucher ITC method was then used to compare efficacy and safety outcomes between perampanel and brivaracetam. Additional subgroup analyses, by levetiracetam usage (prior or concomitant), were conducted.
RESULTS


Eight RCTs (four comparing perampanel to placebo, four comparing brivaracetam to placebo) were included in the ITC. For patients taking concomitant levetiracetam, perampanel showed a significantly better responder rate compared to brivaracetam [relative risk (RR) and 95 % confidence interval (CI): 2.62 (1.15, 5.99)]. For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate. In the overall population, both perampanel and brivaracetam were more effective than placebo in terms of responder rate, seizure freedom, and secondarily generalized tonic-clonic seizure responder rate; however, for these outcomes, no evidence of a difference between perampanel and brivaracetam was found. Patients taking brivaracetam showed significantly less dizziness compared to patients taking perampanel. No differences for any other safety outcome were found.
CONCLUSION


Perampanel and brivaracetam are effective for the adjunctive treatment of focal-onset seizures and display similar adverse event profiles. Perampanel demonstrated an improved focal-onset seizure responder rate compared to brivaracetam in patients taking concomitant levetiracetam. This may be due to the similarity in the mechanism of action between brivaracetam and levetiracetam.",2020,"For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate.","['focal-onset seizures', 'patients with focal-onset seizures with or without secondary generalization', 'patients with focal-onset seizures']","['perampanel', 'perampanel versus brivaracetam', 'perampanel or brivaracetam', 'levetiracetam, perampanel', 'Perampanel', 'placebo']","['efficacy and safety outcomes', 'dizziness', 'responder rate', 'responder rate, seizure freedom, and secondarily generalized tonic-clonic seizure responder rate', 'efficacy and safety', 'focal-onset seizure responder rate']","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}]",,0.188512,"For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate.","[{'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Trinka', 'Affiliation': 'FRCP Department of Neurology, Christian Doppler University Hospital, Paracelsus Medical University, Harrerstrasse 79, A-5020, Salzburg, Austria. Electronic address: eugen@trinka.at.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Tsong', 'Affiliation': 'Formerly Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ, 07677, United States. Electronic address: wtsong.esi@gmail.com.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Toupin', 'Affiliation': 'Quantics Biostatistics, Exchange Tower, 19 Canning Street Fourth Floor, Edinburgh, EH3 8EG, United Kingdom. Electronic address: sydney.toupin@outlook.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd. European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'York Health Economics Consortium, Enterprise House, Innovation Way, University of York, York, YO10 5NQ, United Kingdom. Electronic address: katy.wilson@york.ac.uk.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Isojarvi', 'Affiliation': 'York Health Economics Consortium, Enterprise House, Innovation Way, University of York, York, YO10 5NQ, United Kingdom. Electronic address: jaana.isojarvi@york.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Quantics Biostatistics, Exchange Tower, 19 Canning Street Fourth Floor, Edinburgh, EH3 8EG, United Kingdom. Electronic address: Daniel.James@quantics.co.uk.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106403']
1550,32673160,Adaptations to exercise in compensators and noncompensators in the E-MECHANIC Trial.,"Rating of perceived exertion (RPE) and respiratory exchange ratio (RER) have previously been associated with acute exercise compensation. This study examined adaptations in the RPE and RER with long-term exercise training in individuals who did (noncompensators) and did not (compensators) lose the expected amount of weight. Participants ( n  = 110, 71.8% women, means ± SD; age 49 ± 12 yr) completed 24 wk of supervised exercise training at 65-85% V̇o 2peak  to achieve a prescribed dose of 8 kcal·kg body wt -1 ·wk -1  (8 KKW) or 20 KKW. Participants were categorized as noncompensators ( n  = 55) or compensators ( n  = 55) based on the percent of expected weight loss (%EWL) achieved. Changes in RPE and RER during exercise over time (baseline,  week 12 ,  week 24 ) were compared by weight compensation category. Individual %EWL in relation to RPE, RER, and training intensity (%V̇o 2peak ) was evaluated over the same time period. RPE and RER for a given workload decreased from baseline to  week 12  and stabilized through  week 24 , regardless of weight compensation (time  P  < 0.0001). Noncompensators had a higher RPE relative to heart rate, which was partly explained by higher %V̇o 2peak . RPE and %V̇o 2peak  both positively predicted %EWL, independent of age, sex, and exercise dose. Training intensity and RPE were positively associated with weight loss on the individual level, warranting further investigation into self-selection in exercise-based programs. Understanding individual heterogeneity in training intensity and behavioral responses may improve future weight management efforts that involve exercise. NEW & NOTEWORTHY  In sedentary individuals with overweight and obesity, achievement of expected weight loss from long-term exercise training was associated with individual adaptations in perceived exertion. Contrary to our hypothesis, those with higher relative perceived exertion achieved a larger proportion of their expected weight loss, which was partly explained by a higher self-selected exercise training intensity.",2020,"Non-compensators had a higher RPE relative to heart rate, which was partly explained by higher %VO 2peak .","['Participants (n = 110, 71.8% F, mean ± SD age 49 ± 12 years) completed 24 weeks of', 'Participants were categorized as non-compensators (n=55) or compensators (n=55) based on the percent of expected weight loss (%EWL) achieved', 'individuals who did (non-compensators) and did not (compensators']","['supervised exercise training at 65-85% VO 2peak  to achieve a prescribed dose of 8 kcal/kg body weight/week (8 KKW) or 20 KKW', 'RER with long-term exercise training', 'Perceived Exertion (RPE) and respiratory exchange ratio (RER']","['weight loss', 'RPE relative to heart rate']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0560602', 'cui_str': 'kcal/kg body weight'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0200206,"Non-compensators had a higher RPE relative to heart rate, which was partly explained by higher %VO 2peak .","[{'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Fearnbach', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Texas A&M University, College Station, Texas.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': 'University of North Carolina Charlotte, Charlotte, North Carolina.'}, {'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Harris', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00826.2019']
1551,32673213,Barriers and Facilitators for Referrals of Primary Care Patients to Blended Internet-Based Psychotherapy for Depression: Mixed Methods Study of General Practitioners' Views.,"BACKGROUND


Major depressive disorder (MDD) is highly prevalent and often managed by general practitioners (GPs). GPs mostly prescribe medication and show low referral rates to psychotherapy. Many patients remain untreated. Blended psychotherapy (bPT) combines internet-based interventions with face-to-face psychotherapy and could increase treatment access and availability. Effectively implementing bPT in routine care requires an understanding of professional users' perspectives and behavior.
OBJECTIVE


This study aims to identify barriers and facilitators perceived by GPs in referring patients to bPT. Explanations for variations in referral rates were examined.
METHODS


Semistructured interviews were conducted with 12 of 110 GPs participating in a German randomized controlled trial (RCT) to investigate barriers to and facilitators for referrals to bPT for MDD (10 web-based modules, app-based assessments, and 6 face-to-face sessions). The interview guide was based on the theoretical domains framework. The interviews were audio recorded and transcribed verbatim, and the qualitative content was analyzed by 2 independent coders (intercoder agreement, k=0.71). A follow-up survey with 12 interviewed GPs enabled the validation of emergent themes. The differences in the barriers and facilitators identified between groups with different characteristics (eg, GPs with high or low referral rates) were described. Correlations between referrals and characteristics, self-rated competences, and experiences managing depression of the RCT-GPs (n=76) were conducted.
RESULTS


GPs referred few patients to bPT, although varied in their referral rates, and interviewees referred more than twice as many patients as RCT-GPs (interview-GPs: mean 6.34, SD 9.42; RCT-GPs: mean 2.65, SD 3.92). A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-0.31, P<.001. The qualitative findings revealed a total of 19 barriers (B) and 29 facilitators (F), at the levels of GP (B=4 and F=11), patient (B=11 and F=9), GP practice (B=1 and F=3), and sociopolitical circumstances (B=3 and F=6). Key barriers stated by all interviewed GPs included ""little knowledge about internet-based interventions"" and ""patients' lack of familiarity with technology/internet/media"" (number of statements, each k=22). Key facilitators were ""perceived patient suitability, e.g. well-educated, young"" (k=22) and ""no conflict with GP's role"" (k=16). The follow-up survey showed a very high agreement rate of at least 75% for 71% (34/48) of the identified themes. Descriptive findings indicated differences between GPs with low and high referral rates in terms of which and how many barriers (low: mean 9.75, SD 1.83; high: mean 10.50, SD 2.38) and facilitators (low: mean 18.25, SD 4.13; high: mean 21.00; SD 3.92) they mentioned.
CONCLUSIONS


This study provides insights into factors influencing GPs' referrals to bPT as gatekeepers to depression care. Barriers and facilitators should be considered when designing implementation strategies to enhance referral rates. The findings should be interpreted with care because of the small and self-selected sample and low response rates.",2020,"A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-.31, P<.01.",['Qualitative approach: Semi-structured interviews with 12 of 110 GPs participating in a German randomized-controlled trial (E-COMPARED'],"['blended internet-based psychotherapy', 'Blended Psychotherapy (bPT', 'Quantitative approach']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],76.0,0.0501087,"A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-.31, P<.01.","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlicker', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Faculty of Behavioral and Movement Sciences, Section of Clinical Psychology, VU University Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}]",JMIR mental health,['10.2196/18642']
1552,32679040,"Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial.","BACKGROUND


Functional gastrointestinal disorders are common and costly to the health-care system. Most specialist care is provided by a gastroenterologist, but only a minority of patients have improvement in symptoms. Although they have proven to be effective, psychological, behavioural, and dietary therapies are not provided routinely. We aimed to compare the outcome of gastroenterologist-only standard care with multidisciplinary care.
METHODS


In an open-label, single-centre, pragmatic trial, consecutive new referrals of eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders were randomly assigned (1:2) to receive gastroenterologist-only standard care or multidisciplinary clinic care. The multidisciplinary clinic included gastroenterologists, dietitians, gut-focused hypnotherapists, psychiatrists, and behavioural (biofeedback) physiotherapists. Randomisation was stratified by Rome IV disorder and whether referred from gastroenterology or colorectal clinic. Outcomes were assessed at clinic discharge or 9 months after the initial visit. The primary outcome was a score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement. Modified intention-to-treat analysis included all patients who attended at least one clinic visit and who had answered the primary outcome question. This study is registered with ClinicalTrials.gov, NCT03078634.
FINDINGS


Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188 were randomly assigned to receive either standard care (n=65) or multidisciplinary care (n=123). 144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women. 61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians. 26 (57%) patients in the standard-care group and 82 (84%) patients in the multidisciplinary-care group had global symptom improvement (risk ratio 1·50 [95% CI 1·13-1·93]; p=0·00045). 29 (63%) patients in the standard-care group and 81 (83%) patients in the multidisciplinary-care group had adequate relief of symptoms in the past 7 days (p=0·010). Patients in the multidisciplinary-care group were more likely to experience a 50% or higher reduction in all Gastrointestinal Symptom Severity Index symptom clusters than were patients in the standard-care group. Of the patients with irritable bowel syndrome, a 50-point or higher reduction in IBS-SSS occurred in 10 (38%) of 26 patients in the standard care group compared with 39 (66%) of 59 patients in the multidisciplinary-care group (p=0·017). Of the patients with functional dyspepsia, a 50% reduction in the Nepean Dyspepsia Index was noted in three (11%) of 11 patients in the standard-care group and in 13 (46%) of 28 in the multidisciplinary-care group (p=0·47). After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087). The eight SF-36 scales did not differ between the groups at discharge. After treatment, median Somatic Symptom Scale-8 score was higher in the standard-care group than in the multidisciplinary-care group (10 [IQR 7-7] vs 9 [5-13]; p=0·082). Cost per successful outcome was higher in the standard-care group than the multidisciplinary-care group.
INTERPRETATION


Integrated multidisciplinary clinical care appears to be superior to gastroenterologist-only care in relation to symptoms, specific functional disorders, psychological state, quality of life, and cost of care for the treatment of functional gastrointestinal disorders. Consideration should be given to providing multidisciplinary care for patients with a functional gastrointestinal disorder.
FUNDING


None.",2020,"After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087).","['patients with irritable bowel syndrome', 'patients who attended at least one clinic visit and who had answered the primary outcome question', '144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women', 'patients with a functional gastrointestinal disorder', '61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians', 'Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188', 'eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders', 'functional gastrointestinal disorders (MANTRA']","['gastroenterologist-only standard care or multidisciplinary clinic care', 'standard care (n=65) or multidisciplinary care', 'gastroenterologist-only standard care with multidisciplinary care', 'Standard gastroenterologist versus multidisciplinary treatment']","['global symptom improvement (risk ratio 1·50', 'IBS-SSS', 'median EQ-5D-5L quality of life visual analogue scale', 'Gastrointestinal Symptom Severity Index symptom clusters', 'Cost per successful outcome', 'eight SF-36 scales', 'median Somatic Symptom Scale-8 score', 'Nepean Dyspepsia Index', 'adequate relief of symptoms', 'score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement', 'median HADS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0559031', 'cui_str': 'Functional disorder of gastrointestinal tract'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",1632.0,0.109724,"After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087).","[{'ForeName': 'Chamara', 'Initials': 'C', 'LastName': 'Basnayake', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kamm', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia. Electronic address: mkamm@unimelb.edu.au.""}, {'ForeName': 'Annalise', 'Initials': 'A', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': ""Wilson-O'Brien"", 'Affiliation': ""Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Burrell', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Lees-Trinca', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Khera', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kantidakis', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wong', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Salzberg', 'Affiliation': ""Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Thompson', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30215-6']
1553,32680630,"Corrigendum to 'Unmet Needs of US Acute Stroke Survivors Enrolled in a Transitional Care Intervention Trial' [Journal of Stroke and Cerebrovascular Diseases, Vol. 29, No. 2 (February), 2020: 104462].",,2020,,[],[],[],[],[],[],,0.0411084,,"[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Hughes', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI. Electronic address: hughesa@msu.edu.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Woodward', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI.'}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Fritz', 'Affiliation': 'Michigan State University, Department of Epidemiology and Biostatistics, East Lansing, MI.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Swierenga', 'Affiliation': 'Michigan State University, Outreach and Engagement, East Lansing, MI.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Freddolino', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Reeves', 'Affiliation': 'Michigan State University, Department of Epidemiology and Biostatistics, East Lansing, MI.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105044']
1554,32687974,Design and rationale for a randomized trial of a theory- and technology- enhanced physical activity intervention for Latinas: The Seamos Activas II study.,"INTRODUCTION


Latina women report disproportionately high rates of physical inactivity and related chronic health conditions. Physical activity (PA) efforts to date have shown modest success in this at-risk population; thus, more effective interventions are necessary to help Latinas reach national PA guidelines and reduce related health disparities. This paper describes the design, rationale, and baseline findings from the Seamos Activas II intervention.
METHODS/DESIGN


The ongoing RCT will test the efficacy of the Seamos Saludables PA print intervention vs. a theory-and technology-enhanced version (Seamos Activas II). The purpose of the study is to increase the percentage of Latinas meeting the national PA guidelines compared to the prior trial, improve biomarkers related to disease, and extend generalizability to a broader and more representative population of Latinas (i.e. Mexican/Mexican-Americans). Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies. The primary outcome is change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers at 6- and 12-months. Secondary PA outcomes assessed by the 7-Day PA Recall will be used to corroborate findings.
RESULTS


Participants (N = 199) are Latinas 18-65 years (mean = 43.8) of predominantly Mexican origin (89%). At baseline, objectively measured MVPA was 39.51 min/week (SD = 71.20, median = 10) and self-reported MVPA was 12.47 min/week (SD = 22.54, median = 0).Participants reported generally low self-efficacy and higher cognitive vs. behavioral processes of change.
CONCLUSION


Addressing interactivity and accountability through text messaging, and more rigorously targeting theoretical constructs may be key to helping Latinas achieve nationally recommended PA levels and thereby reducing health disparities.",2020,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","['representative population of Latinas (i.e. Mexican/Mexican-Americans', 'Latina women report disproportionately high rates of physical inactivity and related chronic health conditions', 'Participants (N\u202f=\u202f199) are Latinas 18-65\u202fyears (mean\u202f=\u202f43.8) of predominantly Mexican origin (89', 'Latinas']","['Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies', 'theory- and technology- enhanced physical activity intervention']","['low self-efficacy and higher cognitive vs. behavioral processes of change', 'change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2712043', 'cui_str': 'Lacking belief in own ability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0266557,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","[{'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Dori J', 'Initials': 'DJ', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health at University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Mendoza-Vasconez', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Beth C', 'Initials': 'BC', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America; Department of Human Development and Family Studies, University of Connecticut, Storrs, CT, United States of America.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America. Electronic address: bess_marcus@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106081']
1555,32686972,Text message-based lifestyle intervention in primary care patients with hypertension: a randomized controlled pilot trial.,"OBJECTIVE


To evaluate the feasibility of a randomized controlled pilot study with lifestyle-promoting text messages as a treatment for hypertension in primary care.
DESIGN


Randomized controlled pilot trial.
SETTING


Three primary health care centers in southern Sweden.
SUBJECTS


Sixty patients aged 40-80 years with hypertension were included.
MAIN OUTCOME MEASURES


Feasibility of the pilot study, i.e. recruitment rate, dropout rate and eligibility criteria. Secondary outcomes were change in blood pressure and other cardiovascular risk factors.
METHODS


Thirty participants were randomized to the intervention group with four lifestyle-promoting text messages sent every week for six months. The control group received usual care. The baseline and follow-up visits for all 60 patients included measurements of blood pressure, anthropometrics, blood tests and a self-reported questionnaire.
RESULTS


All feasibility criteria (recruitment rate (≥55%), dropout rate (≤15%) and eligibility (60 eligible patients during the four-month inclusion period) for the pilot study were fulfilled. This means that a larger study with a similar design may be conducted. After six months, there were no significant improvements in cardiovascular risk factors. However, we found favorable trends for all secondary outcomes in the intervention group as compared to the control group.
CONCLUSION


Lifestyle modification in patients with hypertension is important to reduce cardiovascular risk. However, primary healthcare has limited resources to work with modifying lifestyle habits. This is the first pilot study to test the feasibility of text message-based lifestyle intervention in patients with hypertension in Swedish primary healthcare. Whether significant improvement in cardiovascular risk factors may be achieved in a larger study population remains to be evaluated. Key points This pilot randomized controlled trial (RCT) is the first study to evaluate the feasibility of text message-based lifestyle advice to patients with hypertension in Swedish primary healthcare. •All feasibility criteria for the pilot study were fulfilled. This outcome means that a larger study with a similar design may be conducted. •The study was not powered to find significant changes in cardiovascular risk factors. Nevertheless, after six months we found favorable trends for all secondary outcomes in the intervention group compared to control. •If a future larger study can show significant results, this intervention could serve as a useful tool in everyday primary healthcare.",2020,"After six months, there were no significant improvements in cardiovascular risk factors.","['primary care patients with hypertension', 'hypertension in primary care', 'Sixty patients aged 40-80\u2009years with hypertension were included', 'patients with hypertension', 'patients with hypertension in Swedish primary healthcare', 'Three primary health care centers in southern Sweden', 'Thirty participants']","['text message-based lifestyle advice', 'text message-based lifestyle intervention', 'usual care', 'lifestyle-promoting text messages', 'Text message-based lifestyle intervention']","['dropout rate', 'blood pressure, anthropometrics, blood tests and a self-reported questionnaire', 'blood pressure and other cardiovascular risk factors', 'cardiovascular risk factors']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",30.0,0.0772197,"After six months, there were no significant improvements in cardiovascular risk factors.","[{'ForeName': 'Beata Borgström', 'Initials': 'BB', 'LastName': 'Bolmsjö', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Veronica Milos', 'Initials': 'VM', 'LastName': 'Nymberg', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Sandberg', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Midlöv', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Calling', 'Affiliation': 'Department of Clinical Sciences Malmö, Lund University, Sweden.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1794392']
1556,32682494,"Glecaprevir-pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies- a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2).","BACKGROUND


Glecaprevir-pibrentasvir results in high rates of sustained virological response in patients with chronic hepatitis C virus (HCV) genotype 1-6 infection. Data for glecaprevir-pibrentasvir in non-Japanese Asian patients have been minimal. The aim of these studies was to assess the efficacy and safety of glecaprevir-pibrentasvir in treatment-naive and treatment-experienced Asian patients with chronic HCV genotype 1-6 infection without cirrhosis (VOYAGE-1) and with compensated cirrhosis (VOYAGE-2).
METHODS


We did two phase 3 studies in treatment-naive and treatment-experienced patients with chronic HCV genotype 1-6 infection. VOYAGE-1 was a randomised, double-blind, placebo-controlled study that recruited patients without cirrhosis at 47 sites across China, South Korea, and Singapore. Randomisation was 2:1 with a fixed block size of three and stratified by geographical region and HCV genotype. Investigators, study site personnel, the study sponsor, and patients were masked to treatment allocation. VOYAGE-2 was a single-arm, open-label study that recruited patients with compensated cirrhosis at 34 sites across China and South Korea. Glecaprevir (300 mg) and pibrentasvir (120 mg) or placebo (VOYAGE-1, 2:1 ratio), administered as three tablets daily, was given for 8 weeks in patients without cirrhosis and for 12 weeks in those with cirrhosis (and for 16 weeks in treatment-experienced patients with genotype 3). The primary efficacy endpoint was the proportion of patients with a sustained virological response, defined as HCV RNA below the lower limit of quantification 12 weeks after the last dose of glecaprevir-pibrentasvir. We analysed efficacy and safety in all patients who received at least one dose of the study drug. These trials are registered with ClinicalTrials.gov, NCT03222583 (VOYAGE-1) and NCT03235349 (VOYAGE-2); both trials have been completed. This Article reports the results of the primary analysis for each study, undertaken when all patients who received glecaprevir-pibrentasvir (during the double-blind period in VOYAGE-1) had been followed up for 12 weeks following their last dose of study drug. Data from the double-blind period for placebo patients in VOYAGE-1 are also summarised.
FINDINGS


Between Oct 4, 2017, and April 20, 2018, 546 patients with chronic HCV without cirrhosis were randomly assigned to treatment (363 to glecaprevir-pibrentasvir, 183 to placebo) in VOYAGE-1. One patient withdrew consent and did not receive treatment with glecaprevir-pibrentasvir. 352 of 362 patients who received glecaprevir-pibrentasvir achieved SVR12 (97·2% [95% CI 95·5-98·9]). Of 160 patients with compensated cirrhosis who were enrolled in VOYAGE-2 between Sept 29, 2017, and June 14, 2018, 159 of 160 achieved SVR12 (99·4%, 95% CI 98·2-100·0). 20 patients with HCV genotype 3b across both trials received glecaprevir-pibrentasvir; six of these patients were among the 11 patients who did not achieve SVR12. Upper respiratory tract infection was the most common adverse event (35 [10%] of 362 receiving glecaprevir-pibrentasvir and 18 [10%] of 183 receiving placebo in VOYAGE-1; 19 [12%] of 160 in VOYAGE-2). For patients receiving glecaprevir-pibrentasvir, serious adverse events occurred in three (<1%) of 362 patients in VOYAGE-1 and five (3%) of 160 patients in VOYAGE-2. Grade 3-4 adverse events in patients receiving glecaprevir-pibrentasvir occurred in five (1%) of 362 patients in VOYAGE-1 and six (4%) of 160 patients in VOYAGE-2; each type of event was experienced by at most one patient within a study. One patient with cirrhosis discontinued study drug because of an adverse event.
INTERPRETATION


Glecaprevir-pibrentasvir showed high efficacy and an acceptable safety profile in these studies although responses were less common in the few patients with HCV genotype 3b. The results support the use of glecaprevir-pibrentasvir in these Asian populations.
FUNDING


AbbVie.",2020,Upper respiratory tract infection was the most common adverse event (35 [10%] of 362 receiving glecaprevir-pibrentasvir and 18 [10%] of 183 receiving placebo in VOYAGE-1; 19 [12%] of 160 in VOYAGE-2).,"['all patients who received at least one dose of the study drug', 'patients with chronic hepatitis C virus (HCV) genotype 1-6 infection', 'Asian patients with chronic HCV genotype 1-6 infection without cirrhosis (VOYAGE-1) and with compensated cirrhosis (VOYAGE-2', 'recruited patients without cirrhosis at 47 sites across China, South Korea, and Singapore', 'patients with compensated cirrhosis at 34 sites across China and South Korea', '546 patients with chronic HCV without cirrhosis', '352 of 362 patients who received', '160 patients with compensated cirrhosis who were enrolled in VOYAGE-2 between Sept 29, 2017, and June 14, 2018, 159 of 160 achieved SVR12 (99·4%, 95% CI 98·2-100·0', '20 patients with HCV genotype 3b across both trials received glecaprevir-pibrentasvir; six of these patients were among the 11 patients who did not achieve SVR12', 'non-Japanese Asian patients']","['glecaprevir-pibrentasvir', 'Glecaprevir', 'Glecaprevir-pibrentasvir', 'glecaprevir-pibrentasvir achieved SVR12', 'pibrentasvir (120 mg) or placebo', 'placebo']","['efficacy and safety', 'Upper respiratory tract infection', 'proportion of patients with a sustained virological response, defined as HCV RNA', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C1533728', 'cui_str': 'Hepatitis C virus genotype determination'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}, {'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C4519537', 'cui_str': 'pibrentasvir'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.347295,Upper respiratory tract infection was the most common adverse event (35 [10%] of 362 receiving glecaprevir-pibrentasvir and 18 [10%] of 183 receiving placebo in VOYAGE-1; 19 [12%] of 160 in VOYAGE-2).,"[{'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Peking University Hepatology Institute, Peking University People's Hospital, Beijing, China; Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.""}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Negar N', 'Initials': 'NN', 'LastName': 'Alami', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Center of Liver Diseases, Beijing Di Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Busan, South Korea.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, Rui Jin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Mingxiang', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Shenyang Sixth People's Hospital, Shenyang, China.""}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seng Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'National University Healthcare System, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Fredrick', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Hari V', 'Initials': 'HV', 'LastName': 'Kalluri', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Tripathi', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Mobashery', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Burroughs', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Armen', 'Initials': 'A', 'LastName': 'Asatryan', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Infectious Diseases and Hepatology Unit, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. Electronic address: jlhousmu@163.com.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30086-8']
1557,32690203,An RCT to Increase Breast and Colorectal Cancer Screening.,"INTRODUCTION


Adherence to breast and colorectal cancer screenings reduce mortality from these cancers, yet screening rates remain suboptimal. This 2 × 2 RCT compared 3 theory-based interventions to usual care to simultaneously increase breast and colon cancer screening in women who were nonadherent to both screenings at study entry.
DESIGN


RCT.
SETTING/PARTICIPANTS


Women (n=692) who were nonadherent to both breast and colon cancer screenings and aged 51-75 years were recruited. Enrollment, intervention delivery, and data collection were completed between 2013 and 2017, and data analyzed in 2018.
INTERVENTION


The randomized intervention included the following 4 groups: 3 intervention arms (personally tailored messages using a web-based intervention, phone delivery by a trained navigator, or both) compared with usual care. Women at an average risk for colon cancer were allowed to select either colonoscopy or stool test as their preferred colon cancer screening. Mammography was promoted for breast cancer screening.
MAIN OUTCOME MEASURES


Outcome data at 6 months included self-report and medical records for screening activity.
RESULTS


All intervention arms significantly increased receipt of either a mammogram or stool test compared with control (web: p<0.0249, phone: p<0.0001, web + phone: p<0.0001). When considering receipt of both mammogram and stool test, all intervention arms were significantly different from usual care (web: p<0.0249, phone: p<0.0003, web + phone: p<0.0001). In addition, women who were adherent to mammography had a 4.5 times greater odds of becoming adherent to colonoscopy.
CONCLUSIONS


The tailored intervention simultaneously supporting both breast and colon cancer screenings significantly improved rates of obtaining one of the screenings and increased receipt of both tests.
TRIAL REGISTRATION


This study is registered with the clinical trials identifier NCT03279198 at www.clinicaltrials.gov.",2020,"All intervention arms significantly increased receipt of either a mammogram or stool test compared with control (web: p<0.0249, phone:","['Women (n=692) who were nonadherent to both breast and colon cancer screenings and aged 51-75 years were recruited', 'women who were nonadherent to both screenings at study entry', 'Women at an average risk for colon cancer']","['RCT', '3 intervention arms (personally tailored messages using a web-based intervention, phone delivery by a trained navigator, or both) compared with usual care', 'Mammography', 'RCT compared 3 theory-based interventions to usual care to simultaneously increase breast and colon cancer screening']","['self-report and medical records for screening activity', 'rates of obtaining one of the screenings and increased receipt of both tests', 'receipt of either a mammogram or stool test']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0222605', 'cui_str': 'Both breasts'}, {'cui': 'C0554837', 'cui_str': 'Screening for malignant neoplasm of colon'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0554837', 'cui_str': 'Screening for malignant neoplasm of colon'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}]",,0.0798623,"All intervention arms significantly increased receipt of either a mammogram or stool test compared with control (web: p<0.0249, phone:","[{'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Department of Community and Health Systems, Indiana University School of Nursing, Indianapolis, Indiana; Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana. Electronic address: vchampio@iu.edu.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Christy', 'Affiliation': 'Department of Health Outcomes and Behavior, Division of Population Science, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, Florida.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Rakowski', 'Affiliation': 'Professor Emeritus, Brown University, Providence, Rhode Island.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lairson', 'Affiliation': 'School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Richard M. Fairbanks School of Public Health, Indianapolis, Indiana.'}, {'ForeName': 'Wambui G', 'Initials': 'WG', 'LastName': 'Gathirua-Mwangi', 'Affiliation': 'Department of Community and Health Systems, Indiana University School of Nursing, Indianapolis, Indiana.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Stump', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Richard M. Fairbanks School of Public Health, Indianapolis, Indiana; Department of Psychology, Purdue School of Science, Indianapolis, Indiana.'}, {'ForeName': 'Erika B', 'Initials': 'EB', 'LastName': 'Biederman', 'Affiliation': 'Department of Community and Health Systems, Indiana University School of Nursing, Indianapolis, Indiana.'}, {'ForeName': 'Carla D', 'Initials': 'CD', 'LastName': 'Kettler', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Richard M. Fairbanks School of Public Health, Indianapolis, Indiana.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'Department of Science of Nursing Care, Indiana University School of Nursing, Indianapolis, Indiana.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.03.008']
1558,32690738,Risk assessment and antibiotic prescribing decisions in children presenting to UK primary care with cough: a vignette study.,"OBJECTIVES


The validated 'STARWAVe' (Short illness duration, Temperature, Age, Recession, Wheeze, Asthma, Vomiting) clinical prediction rule (CPR) uses seven variables to guide risk assessment and antimicrobial stewardship in children presenting with cough. We aimed to compare general practitioners' (GPs) risk assessments and prescribing decisions to those of STARWAVe and assess the influence of the CPR's clinical variables.
SETTING


Primary care.
PARTICIPANTS


252 GPs, currently practising in the UK.
DESIGN


GPs were randomly assigned to view four (of a possible eight) clinical vignettes online. Each vignette depicted a child presenting with cough, who was described in terms of the seven STARWAVe variables. Systematically, we manipulated patient age (20 months vs 5 years), illness duration (3 vs 6 days), vomiting (present vs absent) and wheeze (present vs absent), holding the remaining STARWAVe variables constant.
OUTCOME MEASURES


Per vignette, GPs assessed risk of hospitalisation and indicated whether they would prescribe antibiotics or not.
RESULTS


GPs overestimated risk of hospitalisation in 9% of vignette presentations (88/1008) and underestimated it in 46% (459/1008). Despite underestimating risk, they overprescribed: 78% of prescriptions were unnecessary relative to GPs' own risk assessments (121/156), while 83% were unnecessary relative to STARWAVe risk assessments (130/156). All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95% CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (OR vomit  2.17, 95% CI 1.32 to 3.57, p=0.002; OR wheeze  8.98, 95% CI 4.99 to 16.15, p<0.001).
CONCLUSIONS


Relative to STARWAVe, GPs underestimated risk of hospitalisation, overprescribed and appeared to misinterpret illness duration (prescribing for longer rather than shorter illnesses). It is important to ascertain discrepancies between CPRs and current clinical practice. This has implications for the integration of CPRs into the electronic health record and the provision of intelligible explanations to decision-makers.",2020,"All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95% CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (OR vomit  2.17, 95% CI 1.32 to 3.57, p=0.002; OR wheeze  8.98, 95% CI 4.99 to 16.15, p<0.001).
","['children presenting with cough', '252 GPs, currently practising in the UK', 'children presenting to UK primary care with cough']",[],"['illness duration', 'vomiting', 'risk of hospitalisation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",252.0,0.0689741,"All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95% CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (OR vomit  2.17, 95% CI 1.32 to 3.57, p=0.002; OR wheeze  8.98, 95% CI 4.99 to 16.15, p<0.001).
","[{'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Nurek', 'Affiliation': 'Surgery and Cancer, Imperial College London, London, UK m.nurek@imperial.ac.uk.'}, {'ForeName': 'Brendan C', 'Initials': 'BC', 'LastName': 'Delaney', 'Affiliation': 'Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kostopoulou', 'Affiliation': 'Surgery and Cancer, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035761']
1559,32690739,Study protocol for the POPART study-Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial.,"INTRODUCTION


Many preterm infants develop respiratory distress syndrome (RDS), a condition characterised by a relative lack of surfactant. Endotracheal surfactant therapy revolutionised the care of preterm infants in the 1990s. However, supporting newborns with RDS with continuous positive airway pressure (CPAP) and reserving endotracheal surfactant for those who develop respiratory failure despite CPAP yield better results than intubating all infants for surfactant. Half of preterm infants born before 29 weeks gestation initially managed with CPAP are intubated for surfactant. Intubation is difficult to learn and associated with adverse effects. Surfactant administration into the oropharynx has been reported in preterm animals and humans and may be effective. We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.
METHODS AND ANALYSIS


Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial (POPART, Eudract No. 2016-004198-41) is an investigator-led, unblinded, multicentre, randomised, parallel group, controlled trial. Infants are eligible if born at a participating centre before 29 weeks gestational age (GA) and there is a plan to offer intensive care. Infants are excluded if they have major congenital anomalies. Infants are randomised at birth to treatment with oropharyngeal surfactant (120 mg vial <26 weeks GA stratum; 240 mg vial 26-28 +6  weeks GA stratum) in addition to CPAP or CPAP alone. The primary outcome is intubation within 120 hours of birth, for bradycardia and/or apnoea despite respiratory support in the delivery room or respiratory failure in the intensive care unit. Secondary outcomes include incidence of mechanical ventilation, endotracheal surfactant use, chronic lung disease and death before hospital discharge.
ETHICS AND DISSEMINATION


Approval for the study has been granted by the Research Ethics Committees at the National Maternity Hospital, Dublin, Ireland (EC31.2016) and at each participating site. The trial is being conducted at nine centres in six European countries. The study results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


2016-004198-41; Pre-results.",2020,"We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.
","['Many preterm infants develop respiratory distress syndrome (RDS', 'newborns with RDS with continuous positive airway pressure (CPAP', 'Infants are eligible if born at a participating centre before 29 weeks gestational age (GA) and there is a plan to offer intensive care', 'nine centres in six European countries', 'preterm infants in the 1990s', 'Preterm infants', 'preterm infants born before 29 weeks gestation initially managed with', 'preterm infants within 120\u2009hours of birth']","['Endotracheal surfactant therapy', 'oropharyngeal surfactant', 'CPAP', 'Prophylactic Oropharyngeal surfactant', 'CPAP or CPAP alone']","['intubation within 120\u2009hours of birth, for bradycardia and/or apnoea despite respiratory support in the delivery room or respiratory failure in the intensive care unit', 'incidence of mechanical ventilation, endotracheal surfactant use, chronic lung disease and death before hospital discharge']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",,0.44978,"We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.
","[{'ForeName': 'Madeleine Claire', 'Initials': 'MC', 'LastName': 'Murphy', 'Affiliation': 'Department of Neonatology, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Galligan', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Molloy', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Hussain', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Colm', 'Initials': 'C', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Neonatology, National Maternity Hospital, Dublin, Ireland codonnell@nmh.ie.'}]",BMJ open,['10.1136/bmjopen-2019-035994']
1560,32690743,Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU).,"OBJECTIVE


To determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing.
DESIGN


Pragmatic parallel group randomised controlled trial.
SETTING


Community-dwelling participants.
PARTICIPANTS


People aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm 2  or both).
INTERVENTION


Wool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression.
PRIMARY AND SECONDARY OUTCOME MEASURES


Healing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events.
RESULTS


We screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference -6.4%, 95% CI -22.5% to 9.7%), change in ulcer area (-1.9 cm 2 , 95% CI -16.5 to 12.8 cm 2 ), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI -12.4% to 24.9%).
CONCLUSION


The effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear.
TRIAL REGISTRATION NUMBER


NCT02896725.",2020,"There were no significant differences between the groups on the primary outcome (risk difference -6.4%, 95% CI -22.5% to 9.7%), change in ulcer area (-1.9 cm 2 , 95% CI -16.5 to 12.8 cm 2 ), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses.","['slow healing venous leg ulceration', 'People aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm 2  or both', 'The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women', 'Community-dwelling participants', '1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group']","['Wool-derived keratin dressings versus usual care dressings', 'Wool-derived keratin dressing', 'keratin dressing']","['change in ulcer area', 'time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events', 'incidence of adverse events', 'time to complete healing']","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3876144', 'cui_str': 'Keratin dressing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0043220', 'cui_str': 'Wool'}, {'cui': 'C3876144', 'cui_str': 'Keratin dressing'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1068.0,0.218728,"There were no significant differences between the groups on the primary outcome (risk difference -6.4%, 95% CI -22.5% to 9.7%), change in ulcer area (-1.9 cm 2 , 95% CI -16.5 to 12.8 cm 2 ), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jull', 'Affiliation': 'School of Nursing, University of Auckland, Auckland, Auckland, New Zealand a.jull@auckland.ac.nz.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wadham', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parag', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Weller', 'Affiliation': 'School of Nursing and Midwifery, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Waters', 'Affiliation': 'Hope Foundation for Research on Ageing, Auckland, New Zealand.'}]",BMJ open,['10.1136/bmjopen-2019-036476']
1561,32690749,Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol.,"INTRODUCTION


The radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding complications. Patients with complex coronary lesions are under-represented in randomised trials comparing radial with femoral access with regard to safety and efficacy. The femoral artery is currently the most applied access site in patients with complex coronary lesions, especially when large bore guiding catheters are required. With slender technology, transradial PCI may be increasingly applied in patients with complex coronary lesions when large bore guiding catheters are mandatory and might be a safer alternative as compared with the transfemoral approach.
METHODS AND ANALYSIS


A total of 388 patients undergoing complex PCI will be randomised to radial 7 French access with Terumo Glidesheath Slender (Terumo, Japan) or femoral 7 French access as comparator. The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Procedural success and major adverse cardiovascular events up to 1 month will also be compared between both groups.
ETHICS AND DISSEMINATION


Ethical approval for the study was granted by the local Ethics Committee at each recruiting center ('Medisch Ethische Toetsing Commissie Isala Zwolle', 'Commissie voor medische ethiek ZNA', 'Comité Medische Ethiek Ziekenhuis Oost-Limburg', 'Comité d'éthique CHU-Charleroi-ISPPC', 'Commission cantonale d'éthique de la recherche CCER-Republique et Canton de Geneve', 'Ethik Kommission de Ärztekammer Nordrhein' and 'Riverside Research Ethics Committee'). The trial outcomes will be published in peer-reviewed journals of the concerned literature.
TRIAL REGISTRATION NUMBER


NCT03846752.",2020,The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention.,"['388 patients undergoing', 'Patients with complex coronary lesions', 'patients with complex coronary lesions']","['radial 7 French access with Terumo Glidesheath Slender (Terumo, Japan) or femoral 7 French access as comparator', 'percutaneous coronary intervention (PCI', 'Complex Large-Bore Radial percutaneous coronary intervention', 'complex PCI']","['safety and efficacy', 'incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention', 'Procedural success and major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C2945608', 'cui_str': 'Bore'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",388.0,0.369498,The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention.,"[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Meijers', 'Affiliation': 'Cardiology, Isala Hospitals, Zwolle, The Netherlands.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Wallonie, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Teeuwen', 'Affiliation': 'Cardiology, Catharina Hospital, Eindhoven, Noord Brabant, The Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmitz', 'Affiliation': 'Cardiology, Elisabeth-Krankenhaus-Essen GmbH, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Maurits T', 'Initials': 'MT', 'LastName': 'Dirksen', 'Affiliation': 'Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, Noord-Holland, The Netherlands.'}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Cardiology, OLVG, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Iglesias', 'Affiliation': 'Cardiology, Geneva University Hospitals, Geneve, Genève, Switzerland.'}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Cardiology, ZNA, Antwerpen, Belgium.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Dens', 'Affiliation': 'Cardiology, Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Cardiology, Amsterdam UMC - Locatie VUMC, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Rathore', 'Affiliation': 'Cardiology, Frimley Health NHS Foundation Trust, Frimley, Surrey, UK.'}, {'ForeName': 'Jan Paul', 'Initials': 'JP', 'LastName': 'Ottervanger', 'Affiliation': 'Cardiology, Isala Hospitals, Zwolle, The Netherlands.'}, {'ForeName': 'Jan-Henk E', 'Initials': 'JE', 'LastName': 'Dambrink', 'Affiliation': 'Cardiology, Isala Hospitals, Zwolle, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Roolvink', 'Affiliation': 'Cardiology, Isala Hospitals, Zwolle, The Netherlands.'}, {'ForeName': 'A T Marcel', 'Initials': 'ATM', 'LastName': 'Gosselink', 'Affiliation': 'Cardiology, Isala Hospitals, Zwolle, The Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Cardiology, Isala Hospitals, Zwolle, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Cardiology, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Cardiology, Isala Hospitals, Zwolle, The Netherlands m.a.h.van.leeuwen@isala.nl.'}]",BMJ open,['10.1136/bmjopen-2020-038042']
1562,32705834,[Clinical observation on electroacupuncture combined with moxibustion for treatment of urinary incontinence after stroke due to deficiency of kidney- yang ].,"OBJECTIVE


To observe the clinical effect of electroacupuncture combined with moxibustion in the treatment of urinary incontinence after stroke due to deficiency of kidney- yang .
METHODS


Sixty patients with urinary incontinence after stroke due to kidney- yang  deficiency were randomly divided into a control group and an observation group，with 30 cases in each group. The patients in the control group were given oral administration of Jingui Shenqi pills and Suoquan capsules. On the basis of the treatment in the control group, the patients in the observation group were given electroacupuncture treatment at the Foot Motor sensory Area on the head, Shenshu(BL23) and Huiyang(BL35), together with moxibustion at Guanyuan(CV4) and Qihai(CV6) once daily. The treatment was conducted 6 times per week and for 2 successive weeks. The average number of daily urinary incontinence and night urinary incontinence, maximum bladder volume, residual bladder urine volume, degree of urinary incontinence and clinical symptoms score of the two groups before and after treatment were observed. And the clinical efficacy of the two groups were compared.
RESULTS


After the treatment, compared with those before the treatment, the average numbers of daily and night urinary incontinence of the two groups were significantly reduced ( P <0.01), the maximum bladder volume was significantly increased ( P <0.05), and the residual urine volume of the bladder was significantly reduced ( P <0.05). The number of cases with urinary incontinence degree Ⅰ and Ⅱ increased ( P <0.05), and the score of clinical symptoms of urinary incontinence was significantly reduced ( P <0.05). After the treatment, compared with the control group, the number of daily and night urinary incontinence in the observation group decreased ( P <0.05), the maximum bladder volume increased ( P <0.05), the residual bladder urine volume decreased ( P <0.05), and the number of cases with urinary incontinence degree Ⅰ and Ⅱ increased ( P <0.05), the clinical symptom score of urinary incontinence was significantly reduced ( P <0.05). The total effective rates of the control group and the observation group were 73.3% (22/30) and 93.3% (28/30) respectively, and the effective rate of the observation group was higher than that of the control group ( P <0.05).
CONCLUSION


The combination of electroacupuncture, moxibustion and traditional Chinese medicine is effective in treating urinary incontinence after stroke due to deficiency of kidney- yang .",2020,"After the treatment, compared with the control group, the number of daily and night urinary incontinence in the observation group decreased ( P <0.05), the maximum bladder volume increased ( P <0.05), the residual bladder urine volume decreased ( P <0.05), and the number of cases with urinary incontinence degree Ⅰ and Ⅱ increased ( P <0.05), the clinical symptom score of urinary incontinence was significantly reduced ( P <0.05).","['Sixty patients with urinary incontinence after stroke due to kidney- yang  deficiency', 'urinary incontinence after stroke due to deficiency of kidney- yang ']","['electroacupuncture combined with moxibustion', 'electroacupuncture treatment at the Foot Motor sensory Area on the head, Shenshu(BL23) and Huiyang(BL35), together with moxibustion at Guanyuan(CV4) and Qihai(CV6', 'oral administration of Jingui Shenqi pills and Suoquan capsules', 'electroacupuncture, moxibustion and traditional Chinese medicine']","['total effective rates', 'score of clinical symptoms of urinary incontinence', 'number of daily and night urinary incontinence', 'residual bladder urine volume', 'clinical symptom score of urinary incontinence', 'residual urine volume of the bladder', 'maximum bladder volume', 'number of cases with urinary incontinence degree Ⅰ and Ⅱ', 'average numbers of daily and night urinary incontinence', 'effective rate', 'average number of daily urinary incontinence and night urinary incontinence, maximum bladder volume, residual bladder urine volume, degree of urinary incontinence and clinical symptoms score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085258', 'cui_str': 'Yang deficiency'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C1721493', 'cui_str': 'jingui shenqi'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429770', 'cui_str': 'Bladder volume'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4759318', 'cui_str': 'Daily urinary incontinence'}]",60.0,0.0179437,"After the treatment, compared with the control group, the number of daily and night urinary incontinence in the observation group decreased ( P <0.05), the maximum bladder volume increased ( P <0.05), the residual bladder urine volume decreased ( P <0.05), and the number of cases with urinary incontinence degree Ⅰ and Ⅱ increased ( P <0.05), the clinical symptom score of urinary incontinence was significantly reduced ( P <0.05).","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Taikang Yanyuan Rehibilitation Hospital of Beijing, Beijing 102200, China.'}, {'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Lu', 'Affiliation': 'Taikang Yanyuan Rehibilitation Hospital of Beijing, Beijing 102200, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.200300']
1563,32705835,[Effect of elongated-needle by Hui-puncture method on piriformis syndrome].,"OBJECTIVE


To observe the clinical effect of elongated needle by Hui-puncture method in the treatment of piriformis syndrome.
METHODS


A total of 100 piriformis syndrome patients were randomly divided into routine acupuncture group ( n ＝50) and elongated needle by Hui-puncture method (Hui-puncture) group ( n ＝50). For patients of the routine acupuncture group, Huantiao (GB30), Juliao (GB29), Zhibian (BL54), Weizhong (BL40), Yanglingquan (GB34), Juegu (GB39) and Ashi-point on the affected side of the body were punctured with filiform needles for 30 min. And for those of the Hui-puncture group, elongated needles were respectively inserted into GB30 and Ashi-point. The treatment was conducted once every other day for 10 times. The visual analog scale (VAS) pain score and the severity scores of symptoms (hip pain, lower limb pain, walking ability, straight leg elevation test, piriformis muscle tension test, piriformis muscle tenderness, 0-15 points) were measured before and after the treatment. The therapeutic effect was assessed by Criteria for Diagnosis and Assessment of Therapeutic Effect of Syndromes or Illnesses of Traditional Chinese Medicine (1994).
RESULTS


After the treatment, the scores of symptoms and VAS scores of both routine acupuncture and Hui-puncture groups were significantly decreased in comparison with their own pre-treatment ( P <0.05), and the scores of the two indexes of the Hui-puncture group were evidently lower than those of the routine acupuncture group ( P <0.05). Of the two 50 cases in the routine acupuncture and Hui-puncture groups, 39 and 47 were effective, with the effective rate being 78.00% and 94.00%, respectively. The comprehensive therapeutic effect of the Hui-puncture group was significantly superior to that of the routine acupuncture group ( P <0.05).
CONCLUSION


Elongated-needle by Hui-puncture method has significant effect in treating piriformis syndrome patients and is worthy of promotion.",2020,"The comprehensive therapeutic effect of the Hui-puncture group was significantly superior to that of the routine acupuncture group ( P <0.05).
","['100 piriformis syndrome patients', 'piriformis syndrome', 'piriformis syndrome patients']","['routine acupuncture group ( n ＝50) and elongated needle by Hui-puncture method (Hui-puncture', 'elongated-needle by Hui-puncture method', 'elongated needle by Hui-puncture method', 'Hui-puncture', 'Elongated-needle by Hui-puncture method', 'routine acupuncture']","['visual analog scale (VAS) pain score and the severity scores of symptoms (hip pain, lower limb pain, walking ability, straight leg elevation test, piriformis muscle tension test, piriformis muscle tenderness, 0-15 points', 'scores of symptoms and VAS scores', 'comprehensive therapeutic effect', 'effective rate', 'Huantiao (GB30), Juliao (GB29), Zhibian (BL54), Weizhong (BL40), Yanglingquan (GB34), Juegu (GB39) and Ashi-point on the affected side of the body']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0458224', 'cui_str': 'Piriformis syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0450634', 'cui_str': 'BL40 - popliteal crease'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",100.0,0.0179744,"The comprehensive therapeutic effect of the Hui-puncture group was significantly superior to that of the routine acupuncture group ( P <0.05).
","[{'ForeName': 'Shi-Sheng', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': ""Department of Acupuntrue, Massage and Traditional Medical Traumatology and Orthopedic, The Sixth People's Hospital, Shanghai 200233, China.""}, {'ForeName': 'Yao-Chi', 'Initials': 'YC', 'LastName': 'Wu', 'Affiliation': ""Department of Acupuntrue, Massage and Traditional Medical Traumatology and Orthopedic, The Sixth People's Hospital, Shanghai 200233, China.""}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190672']
1564,32705941,Use of chest X-ray in the assessment of community acquired pneumonia in primary care - an intervention study.,"OBJECTIVES


The aim of this study was to explore if consequent use of chest X-ray (CXR), when the physician is not sure of the diagnosis of pneumonia after clinical examination and CRP-testing, favors a more restrictive prescribing of antibiotics.
DESIGN


This was an intervention study conducted between September 2015 and December 2017.
SETTING


Two intervention primary health care centers (PHCCs) and three control PHCCs in the southeast of Sweden.
INTERVENTION


All patients were referred for CXR when the physician´s suspicion of pneumonia was 'unsure', or 'quite sure' after CRP-testing. Control units managed patients according to their usual routine after clinical examination and CRP-testing.
SUBJECTS


A total of 104 patients were included in the intervention group and 81 patients in the control group. The inclusion criteria of the study were clinically suspected pneumonia in patients ≥18 years, with respiratory symptoms for more than 24 h.  Main outcome measure:  Antibiotic prescribing rate.
RESULTS


In the intervention group, 85% were referred for CXR and 69% were prescribed antibiotics, as compared to 26% and 77% in the control group. The difference in antibiotic prescribing rate was not statistically significant, unadjusted OR 0.68 [0.35-1.3] and adjusted OR 1.1 [CI 0.43-3.0]. A total of 24% of patients with negative CXR were prescribed antibiotics.
CONCLUSION


This study could not prove that use of CXR when the physician was not sure of the diagnosis of pneumonia results in lowered antibiotic prescribing rate in primary care. In cases of negative findings on CXR the physicians do not seem to rely on the outcome when it comes to antibiotic prescribing. Key Points Routine use of chest X-ray when the clinical diagnosis of pneumonia is uncertain has not been proven to result in lowered antibiotic prescribing rate. Physicians do not fully rely on chest X-ray outcome and to some extent prescribe antibiotics even if negative, when community-acquired pneumonia is suspected. Chest X-ray is already used in one out of four cases in routine primary care of pneumonia patients in Sweden.",2020,"The difference in antibiotic prescribing rate was not statistically significant, unadjusted OR 0.68 [0.35-1.3] and adjusted OR 1.1 [CI 0.43-3.0].","['pneumonia patients in Sweden', 'Two intervention primary health care centers (PHCCs) and three control PHCCs in the southeast of Sweden', 'patients ≥18 years, with respiratory symptoms for more than 24\u2009h.  Main outcome measure:  Antibiotic prescribing rate', 'September 2015 and December 2017', 'Control units managed patients according to their usual routine after clinical examination and CRP-testing', '104 patients were included in the intervention group and 81 patients in the control group']","['chest X-ray', 'chest X-ray (CXR']",['antibiotic prescribing rate'],"[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3873701', 'cui_str': 'Control unit'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",104.0,0.026647,"The difference in antibiotic prescribing rate was not statistically significant, unadjusted OR 0.68 [0.35-1.3] and adjusted OR 1.1 [CI 0.43-3.0].","[{'ForeName': 'Anna B', 'Initials': 'AB', 'LastName': 'Moberg', 'Affiliation': 'Kärna Primary Healthcare Centre, Linköping, Sweden.'}, {'ForeName': 'Moa', 'Initials': 'M', 'LastName': 'Kling', 'Affiliation': 'Kungsgatan Primary Healthcare Centre, Linköping, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Paues', 'Affiliation': 'Department of Health, Medicine and Caring Sciences and Department of Radiological Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sven Göran', 'Initials': 'SG', 'LastName': 'Fransson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, General Practice, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Falk', 'Affiliation': 'Kärna Primary Healthcare Centre, Linköping, Sweden.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2020.1794404']
1565,32709645,Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records.,"INTRODUCTION


The effect of infant nutrition on long-term cognition is important for parents and policy makers. However, most clinical trials typically have short follow-up periods, when measures of cognition are poorly predictive of later function. The few trials with longer-term follow-up have high levels of attrition, which can lead to selection bias, and in turn to erroneous interpretation of long-term harms and benefits of infant nutrition. We address the need for unbiased, long-term follow-up, by linking measures of educational performance from administrative education records. Educational performance is a meaningful marker of cognitive function in children and it is strongly correlated with IQ. We aim to evaluate educational performance for children who, as infants, were part of a series of trials that randomised participants to either nutritionally modified infant formula or standard formula. Most trialists anticipated positive effects of these interventions on later cognitive function.
METHODS AND ANALYSIS


Using data from 1923 participants of seven randomised infant formula trials linked to the English National Pupil Database (NPD), this study will provide new insights into the effect of nutrient intake in infancy on school achievement. Our primary outcome will be the mean differences in z-scores between intervention and control groups for a compulsory Mathematics exam sat at age 16. Secondary outcomes will be z-scores for a compulsory English exam at age 16 and z-scores for compulsory Mathematics and English exams at age 11. We will also evaluate intervention effects on the likelihood of receiving special educational needs (SEN) support. All analyses will be performed separately by trial.
ETHICS AND DISSEMINATION


Research ethics approval, and approval from the Health Research Authority Confidentiality Advisory Group, has been obtained for this study. The results of this study will be disseminated to scientific, practitioner, and lay audiences, submitted for publication in peer-reviewed journals, and will contribute towards a PhD dissertation.",2020,Our primary outcome will be the mean differences in z-scores between intervention and control groups for a compulsory Mathematics exam sat at age 16.,"['1923 participants of seven randomised infant formula trials linked to the English National Pupil Database (NPD', 'children who, as infants']",['nutritionally modified infant formula or standard formula'],"['z-scores for a compulsory English exam at age 16 and z-scores for compulsory Mathematics and English exams at age 11', 'z-scores', 'educational performance']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",1923.0,0.167281,Our primary outcome will be the mean differences in z-scores between intervention and control groups for a compulsory Mathematics exam sat at age 16.,"[{'ForeName': 'Maximiliane', 'Initials': 'M', 'LastName': 'Verfürden', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK m.verfuerden@ucl.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Harron', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jerrim', 'Affiliation': 'Institute of Education, University College London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Gilbert', 'Affiliation': 'Great Ormond Street Institute of Child Health, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035968']
1566,32709656,"Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression: study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study).","INTRODUCTION


The IMPACT study focuses on chronic low back pain (CLBP) and depression symptoms, a prevalent and complex problem that represents a challenge for health professionals. Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively. The objectives of this 12 month, multicentre, randomised, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding a group-based form of ACT or BATD to treatment-as-usual (TAU) for patients with CLBP and moderate to severe levels of depressive symptoms; (ii) identify pre-post differences in levels of some physiological variables and (iii) analyse the role of polymorphisms in the  FKBP5  gene, psychological process measures and physiological variables as mediators or moderators of long-term clinical changes.
METHODS AND ANALYSIS


Participants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain) and Hospital del Mar (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+ACT versus TAU+BATD. A comprehensive assessment to collect clinical variables and costs will be conducted pretreatment, post-treatment and at 12 months follow-up, being pain interference the primary outcome measure. The following physiological variables will be considered at pretreatment and post-treatment assessments in 50% of the sample: immune-inflammatory markers, hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin and vitamin D. Polymorphisms in the  FKBP5  gene (rs3800373, rs9296158, rs1360780, rs9470080 and rs4713916) will be analysed at baseline assessment. Moreover, we will include mobile-technology-based ecological momentary assessment, through the Pain Monitor app, to track ongoing clinical status during ACT and BATD treatments. Linear mixed-effects models using restricted maximum likelihood, and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.
ETHICS AND DISSEMINATION


This study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu and Hospital del Mar. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities.
TRIAL REGISTRATION NUMBER


NCT04140838.",2020,"Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively.","['patients with chronic low back pain and depression', 'patients with CLBP and moderate to severe levels of depressive symptoms', 'patients with persistent pain and depression, respectively', 'Participants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain) and Hospital del Mar (Barcelona, Spain']","['Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment', 'Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment', 'ACT or BATD to treatment-as-usual (TAU', 'TAU vs TAU+ACT\u2009versus TAU+BATD']","['chronic low back pain (CLBP) and depression symptoms', 'immune-inflammatory markers, hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin and vitamin D. Polymorphisms', 'efficacy and cost-utility', 'Efficacy, cost-utility and physiological effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0040643', 'cui_str': 'Corticotropin binding globulin'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",225.0,0.185291,"Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively.","[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Sanabria-Mazo', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos G', 'Initials': 'CG', 'LastName': 'Forero', 'Affiliation': 'Department of Medicine, International University of Catalunya, Barcelona, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cristobal-Narváez', 'Affiliation': 'Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Catalunya, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castelló de la Plana, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castelló de la Plana, Spain.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Colomer-Carbonell', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Pérez-Aranda', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrés-Rodríguez', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'McCracken', 'Affiliation': 'Psychology Department, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Amico"", 'Affiliation': 'Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Estivill-Rodríguez', 'Affiliation': 'Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Catalunya, Spain.'}, {'ForeName': 'Bernat', 'Initials': 'B', 'LastName': 'Carreras-Marcos', 'Affiliation': 'Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Catalunya, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Montes-Pérez', 'Affiliation': 'Consorci Parc de Salut MAR de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Comps-Vicente', 'Affiliation': 'Consorci Parc de Salut MAR de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Esteve', 'Affiliation': 'Biomedical Research Centre in Physiopathology of Obesity and Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Grasa', 'Affiliation': 'Biomedical Research Centre in Physiopathology of Obesity and Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Rosa', 'Affiliation': 'Network Centre for Biomedical Research in Mental Health (CIBERSAM), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Antonio I', 'Initials': 'AI', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maes', 'Affiliation': 'Department of Psychiatry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Borràs', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Edo', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sanz', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Department of Basic, Developmental and Educational Psychology, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan R', 'Initials': 'JR', 'LastName': 'Castaño-Asins', 'Affiliation': 'Consorci Parc de Salut MAR de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Catalunya, Spain jvluciano@pssjd.org.'}]",BMJ open,['10.1136/bmjopen-2020-038107']
1567,32709657,Bridging the gap between physical and mental illness in community pharmacy ( PharMIbridge ): protocol for an Australian cluster randomised controlled trial.,"INTRODUCTION


There is a significant life expectancy gap attributable to physical comorbidities for people living with severe and persistent mental illness (SPMI) compared with the general population. Medications are a major treatment for SPMI management and physical illnesses, hence pharmacists are well positioned to support mental healthcare and comorbidities. The randomised controlled trial (RCT) aim is to evaluate effectiveness of an individualised, pharmacist led, support service for people experiencing SPMI focusing on medication adherence and physical comorbidity management, compared with standard care (a medication-management service; MedsCheck). METHODS AND ANALYSIS:  PharMIbridge  is a cluster RCT, whereby community pharmacies in four Australian regions will be randomised (1:1 ratio), to either Intervention Group (IG) or Comparator Group (CG). All IG and CG pharmacy staff will receive Blended-Mental Health First Aid training. Additionally, IG pharmacists will receive further training on medication adherence, goal setting, motivational interviewing, managing physical health concerns and complex issues relating to psychotropic medication. CG pharmacists will not receive additional training, and will provide standard care (MedsCheck). The primary outcome will be change in participants medication adherence for psychotropic medication over 6-months. Using mixed-effects logistic regression model and a cluster size of 48 pharmacies, a total of 190 participants will need to be recruited to each arm to find a statistically significant difference in medication adherence. Secondary outcomes will be changes in factors associated with cardiometabolic risk and quality of life, emphasising physical and psychological well-being; medication-related problems; adherence to other prescribed medication; pharmacists knowledge, confidence and ability to support people experiencing SPMI; and effects on healthcare utilisation. A within RCT-based economic evaluation comparing the intervention with standard care will be undertaken.
ETHICS AND DISSEMINATION


The protocol and pharmacist training programme received Griffith University Human Research Ethics Committee approval (HREC/2019/473 and HREC/2019/493 respectively). Results will be published in peer-reviewed journals and available at the Sixth Community Pharmacy Agreement website (http://6cpa.com.au/about-6cpa/).
TRIAL REGISTRATION NUMBER


ANZCTR12620000577910.",2020,"The randomised controlled trial (RCT) aim is to evaluate effectiveness of an individualised, pharmacist led, support service for people experiencing SPMI focusing on medication adherence and physical comorbidity management, compared with standard care (a medication-management service; MedsCheck).","['people living with severe and persistent mental illness (SPMI', '48 pharmacies, a total of 190 participants']",['Blended-Mental Health First Aid training'],"['cardiometabolic risk and quality of life, emphasising physical and psychological well-being; medication-related problems; adherence to other prescribed medication; pharmacists knowledge, confidence and ability to support people experiencing SPMI; and effects on healthcare utilisation', 'participants medication adherence for psychotropic medication', 'medication adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}]",190.0,0.139524,"The randomised controlled trial (RCT) aim is to evaluate effectiveness of an individualised, pharmacist led, support service for people experiencing SPMI focusing on medication adherence and physical comorbidity management, compared with standard care (a medication-management service; MedsCheck).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Wheeler', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia a.wheeler@griffith.edu.au.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': ""O'Reilly"", 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sarira', 'Initials': 'S', 'LastName': 'El-Den', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Byrnes', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sara S', 'Initials': 'SS', 'LastName': 'McMillan', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-039983']
1568,32709710,Long-Term Functional Patency and Cost-Effectiveness of Arteriovenous Fistula Creation under Regional Anesthesia: a Randomized Controlled Trial.,"BACKGROUND


Regional anesthesia improves short-term blood flow through arteriovenous fistulas (AVFs). We previously demonstrated that, compared with local anesthesia, regional anesthesia improves primary AVF patency at 3 months.
METHODS


To study the effects of regional versus local anesthesia on longer-term AVF patency, we performed an observer-blinded randomized controlled trial at three university hospitals in Glasgow, United Kingdom. We randomly assigned 126 patients undergoing primary radiocephalic or brachiocephalic AVF creation to receive regional anesthesia (brachial plexus block; 0.5% L-bupivacaine and 1.5% lidocaine with epinephrine) or local anesthesia (0.5% L-bupivacaine and 1% lidocaine). This report includes findings on primary, functional, and secondary patency at 12 months; reinterventions; and additional access procedures (primary outcome measures were previously reported). We analyzed data by intention to treat, and also performed cost-effectiveness analyses.
RESULTS


At 12 months, we found higher primary patency among patients receiving regional versus local anesthesia (50 of 63 [79%] versus 37 of 63 [59%] patients; odds ratio [OR], 2.7; 95% confidence interval [95% CI], 1.6 to 3.8;  P =0.02) as well as higher functional patency (43 of 63 [68%] versus 31 of 63 [49%] patients; OR, 2.1; 95% CI, 1.5 to 2.7;  P =0.008). In 12 months, 21 revisional procedures, 53 new AVFs, and 50 temporary dialysis catheters were required. Regional anesthesia resulted in net savings of £195.10 (US$237.36) per patient at 1 year, and an incremental cost-effectiveness ratio of approximately £12,900 (US$15,694.20) per quality-adjusted life years over a 5-year time horizon. Results were robust after extensive sensitivity and scenario analyses.
CONCLUSIONS


Compared with local anesthesia, regional anesthesia significantly improved both primary and functional AVF patency at 1 year and is cost-effective.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Local Anaesthesia versus Regional Block for Arteriovenous Fistulae, NCT01706354.",2020,"Regional anesthesia resulted in net savings of £195.10 (US$237.36) per patient at 1 year, and an incremental cost-effectiveness ratio of approximately £12,900 (US$15,694.20) per quality-adjusted life years over a 5-year time horizon.","['126 patients undergoing', 'three university hospitals in Glasgow, United Kingdom']","['primary radiocephalic or brachiocephalic', 'regional versus local anesthesia', 'regional anesthesia (brachial plexus block; 0.5% L-bupivacaine and 1.5% lidocaine with epinephrine', 'Arteriovenous Fistula Creation under Regional Anesthesia', 'local anesthesia, regional anesthesia', 'local anesthesia (0.5% L-bupivacaine and 1% lidocaine']","['functional patency', 'primary patency', 'primary AVF patency', 'incremental cost-effectiveness ratio', 'net savings', 'cost-effective', 'functional AVF patency']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0398221', 'cui_str': 'Arteriovenous fistulization'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0449215', 'cui_str': 'aVF'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",126.0,0.356984,"Regional anesthesia resulted in net savings of £195.10 (US$237.36) per patient at 1 year, and an incremental cost-effectiveness ratio of approximately £12,900 (US$15,694.20) per quality-adjusted life years over a 5-year time horizon.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Aitken', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, United Kingdom emmaaitken@nhs.net.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kearns', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Lucian', 'Initials': 'L', 'LastName': 'Gaianu', 'Affiliation': 'Scottish Health Technologies Group, Healthcare Improvement Scotland, Edinburgh, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Steven', 'Affiliation': 'Department of Anaesthesia, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinsella', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clancy', 'Affiliation': 'Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Macfarlane', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain Medicine, University of Glasgow, Glasgow, United Kingdom.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019111209']
1569,32716291,A novel rizatriptan oral gel formulation: Bioavailability and bioequivalence.,"OBJECTIVES


To establish the relative bioavailability between a newly developed oral gel and a marketed oral lyophilisate-containing rizatriptan benzoate.
MATERIALS AND METHODS


A total of 47 out of 48 healthy subjects, aged 34 ± 10 (SD) years and body mass index 24.7 ± 3.3 (SD) kg/m 2  completed this single-center, open-label, randomized, 2-period cross-over trial with single-dose fasted administrations. Intake of both investigational products was separated by a washout period of at least 6 days. For pharmacokinetic evaluation, blood samples were withdrawn until 24 hours post dose. A validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS) was applied for the determination of rizatriptan in plasma. The lower limit of quantitation (LLOQ) was 0.100 ng/mL. Adverse events (AEs) were descriptively analyzed in the study population. Palatability of the new product was investigated based on a questionnaire.
RESULTS


The geometric means of the parameters related with the extent of total exposure, i.e., AUC 0-tlast  and AUC 0-∞ , were 60.285 ng × h/mL and 60.865 ng × h/mL for test and 62.729 ng × h/mL and 63.312 ng × h/mL for reference, respectively. The geometric means of the peak exposure, i.e., C max , were 21.262 ng/mL for test and 21.447 ng/mL for reference. The point estimates (PEs) of the test/reference (T/R) adjusted geometric mean ratios of AUC 0-tlast , C max , and AUC 0-∞  (secondary parameter) were 96.11%, 99.12%, and 96.15%, respectively, and all of them showed 90% confidence intervals (CIs) within the range of 80.00 - 125.00% as suggested by regulatory requirements for bioequivalence assessment. In total, 13 subjects experienced 20 AEs during the trial; the most frequently reported AEs were headache (5 cases) and dizziness (3 cases). No AEs of severe intensity were reported. Palatability assessment of the new product provided sufficient data to discuss its acceptability.
CONCLUSION


Bioequivalence was demonstrated in terms of rate and extent of absorption after administration of test and reference products. Concerning the safety evaluation, no negative implications on the possible use of the test formulation could be determined. Based on ratings by the subjects no relevant problem concerning acceptability of the new formulation in particular regarding taste and smell is to be expected.",2020,Based on ratings by the subjects no relevant problem concerning acceptability of the new formulation in particular regarding taste and smell is to be expected.,"['A total of 47 out of 48 healthy subjects, aged 34 ± 10 (SD) years and body mass index 24.7 ± 3.3 (SD) kg/m2 completed this single-center, open-label, randomized, 2-period cross-over trial with single-dose fasted administrations']",['rizatriptan'],"['headache', 'dizziness', 'lower limit of quantitation (LLOQ', 'severe intensity', 'relative bioavailability', 'geometric mean ratios of AUC 0-tlast , C max , and AUC 0-∞']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0297635', 'cui_str': 'rizatriptan'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",48.0,0.078419,Based on ratings by the subjects no relevant problem concerning acceptability of the new formulation in particular regarding taste and smell is to be expected.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tellone', 'Affiliation': ''}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Dragone', 'Affiliation': ''}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': ''}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Garofolo', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Vecchio', 'Affiliation': ''}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Donath', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schug', 'Affiliation': ''}, {'ForeName': 'Ralph-Steven', 'Initials': 'RS', 'LastName': 'Wedemeyer', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203652']
1570,32713846,Preferences for different diagnostic modalities to follow up abnormal colorectal cancer screening results: a hypothetical vignette study.,"OBJECTIVES


In England, a significant proportion of people who take part in the national bowel cancer screening programme (BCSP) and have a positive faecal occult blood test (FOBt) result, do not attend follow-up colonoscopy (CC). The aim of this study was to investigate differences in intended participation in a follow-up investigation by diagnostic modality offered including CC, CT colonography (CTC) or capsule endoscopy (CE).
SETTING


We performed a randomised online experiment with individuals who had previously completed an FOBt as part of the English BCSP.
METHODS


Participants (n=953) were randomly allocated to receive one of three online vignettes asking participants to imagine they had received an abnormal FOBt result, and that they had been invited for a follow-up test. The follow-up test offered was either: CC (n=346), CTC (n=302) or CE (n=305). Participants were then asked how likely they were to have their allocated test or if they refused, either of the other tests. Respondents were also asked to cite possible emotional and practical barriers to follow up testing. Multivariable logistic regression models were used to investigate intentions.
RESULTS


Intention to have the test was higher in the CTC group (96.7%) compared with the CC group (91.8%; OR 2.64; 95% CI 1.22 to 5.73). CTC was considered less 'off-putting' (OR 0.66, 95% CI 0.47 to 0.94) and less uncomfortable compared with CC (OR 0.51, 95% CI 0.34 to 0.77). For those who did not intend to have the test they were offered, CE (39.7%) or no investigation (34.5%) was preferable to CC (8.6%) or CTC (17.2%).
CONCLUSIONS


Alternative tests have the potential to increase attendance at diagnostic follow-up appointments.",2020,"RESULTS


Intention to have the test was higher in the CTC group (96.7%) compared with the CC group (91.8%; OR 2.64; 95% CI 1.22 to 5.73).","['Participants (n=953', 'individuals who had previously completed an FOBt as part of the English BCSP']","['online vignettes asking participants to imagine they had received an abnormal FOBt result, and that they had been invited for a follow-up test', 'CC, CT colonography (CTC) or capsule endoscopy (CE']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}]",[],953.0,0.0915537,"RESULTS


Intention to have the test was higher in the CTC group (96.7%) compared with the CC group (91.8%; OR 2.64; 95% CI 1.22 to 5.73).","[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Kaushal', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sandro Tiziano', 'Initials': 'ST', 'LastName': 'Stoffel', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK c.wagner@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-035264']
1571,32713847,Evaluation of the teaching recovery techniques community-based intervention for accompanied refugee children experiencing post-traumatic stress symptoms (Accompanied refugeeS In Sweden Trial; ASsIST): study protocol for a cluster randomised controlled trial.,"BACKGROUND


Refugee children have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue for years after resettlement. The Accompanied refugeeS In Sweden Trial (ASsIST) aims to evaluate a community-based intervention, called 'Teaching Recovery Techniques' (TRT), for accompanied refugee minors experiencing PTSD symptoms.
METHODS/DESIGN


A cluster randomised controlled trial will be conducted in which participants will be randomly allocated to one of the two possible arms: the intervention arm (n=113) will be offered the TRT programme and the waitlist-control arm (n=113) will receive services as usual, followed by the TRT programme around 20 weeks later. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; c.8 weeks after randomisation) and follow-up (T3; c.20 weeks after randomisation).
ETHICS AND DISSEMINATION


Ethical approval was granted by the Regional Ethical Review Board in Uppsala (Ref. 2018/382) (24 th  February 2019). Results will be published in scientific journals.
TRIAL REGISTRATION DETAILS


ISRCTN17754931. Prospectively registered on 4 th  June 2019.",2020,"The Accompanied refugeeS In Sweden Trial (ASsIST) aims to evaluate a community-based intervention, called 'Teaching Recovery Techniques' (TRT), for accompanied refugee minors experiencing PTSD symptoms.
","['accompanied refugee children experiencing post-traumatic stress symptoms (Accompanied refugeeS', '2018/382']","['TRT programme and the waitlist-control arm (n=113) will receive services as usual, followed by the TRT programme', 'teaching recovery techniques community-based intervention']",[],"[{'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.230725,"The Accompanied refugeeS In Sweden Trial (ASsIST) aims to evaluate a community-based intervention, called 'Teaching Recovery Techniques' (TRT), for accompanied refugee minors experiencing PTSD symptoms.
","[{'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Warner', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden georgina.warner@pubcare.uu.se.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Durbeej', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Raziye', 'Initials': 'R', 'LastName': 'Salari', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Fängström', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Lampa', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Zaruhi', 'Initials': 'Z', 'LastName': 'Baghdasaryan', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Fatumo', 'Initials': 'F', 'LastName': 'Osman', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gupta Löfving', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Perez Aronsson', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Sampaio', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ssegonja', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjärtå', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Rondung', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Leiler', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Wasteson', 'Affiliation': 'Department of Psychology, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Calam', 'Affiliation': 'Division of Clinical Psychology, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Oppedal', 'Affiliation': 'Division of Mental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Brooks', 'Initials': 'B', 'LastName': 'Keeshin', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sarkadi', 'Affiliation': 'Child Health and Parenting, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-035459']
1572,32719055,What matters most to patients when choosing treatment for mild-moderate asthma? Results from a discrete choice experiment.,"BACKGROUND


An as-needed combination preventer and reliever regimen was recently introduced as an alternative to conventional daily preventer treatment for mild asthma. In a subgroup analysis of the PRACTICAL study, a pragmatic randomised controlled trial of budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild asthma, we recently reported that about two-thirds preferred as-needed combination preventer and reliever therapy. The aim of this study was to determine the relative importance of attributes associated with these two asthma therapies in this subgroup of participants who indicated their preferred treatment in the PRACTICAL study.
METHODS


At their final study visit, a subgroup of participants indicated their preferred treatment and completed a discrete choice experiment using the Potentially All Pairwise RanKings of all possible Alternatives method and 1000minds software. Treatment attributes and their levels were selected from measurable study outcomes, and included: treatment regimen, shortness of breath, steroid dose and likelihood of asthma flare-up.
RESULTS


The final analysis dataset included 288 participants, 64% of whom preferred as-needed combination preventer and reliever. Of the attributes, no shortness of breath and lowest risk of asthma flare-up were ranked highest and second highest, respectively. However, the relative importance of the other two attributes varied by preferred therapy: treatment regimen was ranked higher by participants who preferred as-needed treatment than by participants who preferred maintenance treatment.
CONCLUSIONS


Knowledge of patient preferences for treatment attributes together with regimen characteristics can be used in shared decision-making regarding choice of treatment for patients with mild-moderate asthma.
TRIAL REGISTRATION NUMBER


ACTRN12616000377437.",2020,"However, the relative importance of the other two attributes varied by preferred therapy: treatment regimen was ranked higher by participants who preferred as-needed treatment than by participants who preferred maintenance treatment.
","['288 participants, 64% of whom preferred as-needed combination preventer and reliever', 'adults with mild asthma', 'mild asthma', 'patients with mild-moderate asthma']","['budesonide-formoterol reliever therapy', 'budesonide plus terbutaline reliever therapy']","['shortness of breath, steroid dose and likelihood of asthma flare-up']","[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",288.0,0.0755572,"However, the relative importance of the other two attributes varied by preferred therapy: treatment regimen was ranked higher by participants who preferred as-needed treatment than by participants who preferred maintenance treatment.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baggott', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand christina.baggott@mrinz.ac.nz.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hansen', 'Affiliation': 'Economics, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jo Katherine', 'Initials': 'JK', 'LastName': 'Hardy', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Sparks', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'Medicine, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Glebe, New South Wales, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-214343']
1573,32682174,The renin secretion profile under the influence of sleep deprivation and the neuropeptides CRH and GHRH.,"It is already known that during normal sleep plasma renin activity (PRA) shows oscillations with decreases during rapid-eye-movement (REM) sleep and increases during non-REM (NREM) sleep. We also know that renin correlates positively with slow-wave sleep (SWS). Sleep deprivation is known to enhance significantly SWS and slow wave activity (SWA, known as δ power). Based on these findings we addressed the question whether and to which extent sleep deprivation may affect the synchronization found between PRA and REM sleep during normal sleep and whether this synchronization is affected by other sleep regulating factors. To investigate these questions we compared sleep EEG and sleep-related free renin levels in 48 normal women and men 19-69 years old between nights before and after 40 h of sleep deprivation. During the recovery night, four bolus injections of either GHRH, CRH or placebo were injected via long catheter around sleep onset. When compared to baseline after each of the treatments SWS, SWA and renin levels increased. The characteristical oscillation profiles of renin during normal sleep were also preserved after sleep deprivation. Similar to normal sleep our data support also a distinct link between nocturnal renin secretion and SWS after sleep deprivation and that independent of the applied treatments.",2020,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.",['48 normal women and men 19-69 years old between nights before and after 40\u2009h of sleep deprivation'],"['GHRH, CRH or placebo']","['renin correlates positively with slow-wave sleep (SWS', 'SWA and renin levels', 'sleep EEG and sleep-related free renin levels']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",48.0,0.0236425,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Künzel', 'Affiliation': 'Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Germany; Max-Planck-Institut für Psychiatrie München, Germany. Electronic address: Heike.Kuenzel@med.uni-muenchen.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schüssler', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Regensburg, Klinik und Poliklinik für Psychiatrie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yassouridis', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uhr', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kluge', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Steiger', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104799']
1574,32682347,A PERIOD3 variable number tandem repeat polymorphism modulates melatonin treatment response in delayed sleep-wake phase disorder.,"We examined whether a polymorphism of the PERIOD3 gene (PER3; rs57875989) modulated the sleep-promoting effects of melatonin in Delayed Sleep-Wake Phase Disorder (DSWPD). One hundred and four individuals (53 males; 29.4 ±10.0 years) with DSWPD and a delayed dim light melatonin onset (DLMO) collected buccal swabs for genotyping (PER3 4/4  n = 43; PER3 5 allele [heterozygous and homozygous] n = 60). Participants were randomised to placebo or 0.5 mg melatonin taken 1 hour before desired bedtime (or ~1.45 hours before DLMO), with sleep attempted at desired bedtime (4 weeks; 5-7 nights/week). We assessed sleep (diary and actigraphy), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient-Reported Outcomes Measurement Information System (PROMIS: Sleep Disturbance, Sleep-Related Impairment), Sheehan Disability Scale (SDS) and Patient- and Clinician-Global Improvement (PGI-C, CGI-C). Melatonin treatment response on actigraphic sleep onset time did not differ between genotypes. For PER3 4/4  carriers, self-reported sleep onset time was advanced by a larger amount and sleep onset latency (SOL) was shorter in melatonin-treated patients compared to those receiving placebo (P = .008), while actigraphic sleep efficiency in the first third of the sleep episode (SE T1) did not differ. For PER3 5 carriers, actigraphic SOL and SE T1 showed a larger improvement with melatonin (P < .001). Melatonin improved ISI (P = .005), PROMIS sleep disturbance (P < .001) and sleep-related impairment (P = .017), SDS (P = .019), PGI-C (P = .028) and CGI-C (P = .016) in PER3 4/4  individuals only. Melatonin did not advance circadian phase. Overall, PER3 4/4  DSWPD patients have a greater response to melatonin treatment. PER3 genotyping may therefore improve DSWPD patient outcomes.",2020,"Melatonin improved ISI (P=0.005), PROMIS Sleep Disturbance (P<0.001) and Sleep-Related Impairment (P=0.017), SDS (P=0.019), PGI-C (P=0.028), and CGI-C (P=0.016) in PER3 4/4  individuals only.","['Delayed Sleep-Wake Phase Disorder', 'Delayed Sleep-Wake Phase Disorder (DSWPD', 'One hundred and four individuals (53 males; 29.4±10.0 years) with DSWPD and a delayed dim light melatonin onset (DLMO) collected buccal swabs for genotyping (PER3 4/4  n=43']","['placebo or 0.5mg melatonin', 'melatonin', 'Melatonin', 'placebo']","['sleep (diary and actigraphy), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient-Reported Outcomes Measurement Information System (PROMIS: Sleep Disturbance, Sleep-Related Impairment), Sheehan Disability Scale (SDS), and Patient- and Clinician-Global Improvement (PGI-C, CGI-C', 'sleep onset latency (SOL', 'ISI', 'actigraphic sleep efficiency', 'Sleep-Related Impairment', 'PGI-C', 'actigraphic sleep onset time', 'PROMIS Sleep Disturbance']","[{'cui': 'C0393770', 'cui_str': 'Sleep-wake schedule disorder, delayed phase type'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0581714', 'cui_str': 'Buccal smear procedure'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}]",104.0,0.188696,"Melatonin improved ISI (P=0.005), PROMIS Sleep Disturbance (P<0.001) and Sleep-Related Impairment (P=0.017), SDS (P=0.019), PGI-C (P=0.028), and CGI-C (P=0.016) in PER3 4/4  individuals only.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Magee', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Sletten', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Murray', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gordon', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lovato', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Delwyn J', 'Initials': 'DJ', 'LastName': 'Bartlett', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kennaway', 'Affiliation': 'Robinson Research Institute, Adelaide School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leon C', 'Initials': 'LC', 'LastName': 'Lack', 'Affiliation': 'Adelaide Institute for Sleep Health: A Flinders Centre of Research Excellence, School of Medicine, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Cooperative Research Centre for Alertness, Safety and Productivity, Clayton, Victoria, Australia.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Archer', 'Affiliation': 'Surrey Sleep Research Centre, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pineal research,['10.1111/jpi.12684']
1575,32690516,HIV and other STIs self-testing to reduce risk compensation among men who have sex with men who use oral pre-exposure prophylaxis in China: protocol for a randomised waitlist-controlled trial.,"INTRODUCTION


Pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection among men who have sex with men by up to 99%. However, in real-world settings, PrEP users may exhibit risk compensation after uptake of PrEP, including more condomless anal intercourse (CAI) and increased sexually transmitted infection (STI) acquisition. HIV self-testing (HIVST) decreases CAI among men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one's sexual partners. Here, we describe the rationale and design of a randomised waitlist-controlled trial to examine the impact of HIVST on risk compensation among PrEP users.
METHODS AND ANALYSIS


The study is a two-arm randomised waitlist-controlled trial with 1000 HIV-negative MSM in four major cities in China who will be taking oral PrEP (involving tenofovir disoproxil fumarate/emtricitabine) either daily (n=500) or in an event-driven regimen (n=500). The participants will be randomised (1:1) to either the immediate HIVST intervention arm (HIVST plus standard facility-based counselling and testing from 0 to 12 months) or the waitlist arm (standard facility-based counselling and testing from 0 to 6 months, then crossover to receive the HIVST intervention in months 7-12). Participants will provide blood samples to assess the incidence of syphilis and herpes simplex virus type 2 (HSV-2) during a follow-up. The primary outcomes will be the occurrence of CAI, number of sexual partners and incidence of syphilis and HSV-2 during a follow-up. The secondary outcomes will be the HIV and STI testing frequency and STI treatment adherence during a follow-up. The planned start and end dates for the study is 26 December 2018 and 31 December 2020.
ETHICS AND DISSEMINATION


The Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273).
TRIAL REGISTRATION NUMBER


ChiCTR1800020374.",2020,HIV self-testing (HIVST) decreases CAI among men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one's sexual partners.,"['1000 HIV-negative MSM in four major cities in China who will be taking oral PrEP (involving', 'either daily (n=500) or in an event-driven regimen (n=500', '26 December 2018 and 31 December 2020', ""men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one's sexual partners"", 'men who have sex with men by up to 99', 'men who have sex with men who use oral pre-exposure prophylaxis in China']","['HIVST', 'HIV and other STIs self-testing', 'immediate HIVST intervention arm (HIVST plus standard facility-based counselling and testing from 0 to 12 months) or the waitlist arm (standard facility-based counselling and testing from 0 to 6 months, then crossover to receive the HIVST intervention', 'HIV self-testing (HIVST', 'Pre-exposure prophylaxis (PrEP', 'tenofovir disoproxil fumarate/emtricitabine']","['risk of HIV infection', 'condomless anal intercourse (CAI) and increased sexually transmitted infection (STI) acquisition', 'HIV and STI testing frequency and STI treatment adherence', 'risk compensation', 'occurrence of CAI, number of sexual partners and incidence of syphilis and HSV-2 during a follow-up']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0556463', 'cui_str': 'Number of sexual partners'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0449572', 'cui_str': 'Virus type'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1000.0,0.118556,HIV self-testing (HIVST) decreases CAI among men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one's sexual partners.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yaokai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, China.""}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Mei', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yueru', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'ZhenXing', 'Initials': 'Z', 'LastName': 'Chu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Qing-Hai', 'Initials': 'QH', 'LastName': 'Hu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Chongqing Public Health Medical Center, Chongqing, China.'}, {'ForeName': 'Lukun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, China.""}, {'ForeName': 'Zhili', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Rantong', 'Initials': 'R', 'LastName': 'Bao', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Shangcao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Geng', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina at Chapel Hill Project-China, Guangzhou, China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China xjjcmu@163.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036231']
1576,32690519,Person-centred care by a combined digital platform and structured telephone support for people with chronic obstructive pulmonary disease and/or chronic heart failure: study protocol for the PROTECT randomised controlled trial.,"BACKGROUND


A core feature of chronic obstructive pulmonary disorder (COPD) and chronic heart failure (CHF) is that symptoms may change rapidly because of illness progression. Thus, these chronic conditions are associated with high rehospitalisation rates. Person-centred care (PCC) has been shown to have several benefits for patients with COPD or CHF (or both disorders) but it has not yet been investigated through e-health services.
AIM


The project aims to evaluate the effects of PCC by a combined digital platform and structured telephone support for people with COPD and/or CHF.
METHODS AND ANALYSIS


A randomised controlled trial with open, parallel groups which employs a participatory design process will be used. This project will also include process and health economic evaluation of the intervention.
ETHICS AND DISSEMINATION


Ethical approval has been secured from the Regional Ethical Review Board in Gothenburg, Sweden (Dnr 063-17 and T063-18). Results will be presented at conferences and to healthcare professionals, participants and patient organisations. Findings will also be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03183817.",2020,"Person-centred care (PCC) has been shown to have several benefits for patients with COPD or CHF (or both disorders) but it has not yet been investigated through e-health services.
","['patients with COPD or CHF (or both disorders', 'people with COPD and/or CHF', 'people with chronic obstructive pulmonary disease and/or chronic heart failure']","['Person-centred care (PCC', 'PCC', 'Person-centred care by a combined digital platform and structured telephone support']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.307293,"Person-centred care (PCC) has been shown to have several benefits for patients with COPD or CHF (or both disorders) but it has not yet been investigated through e-health services.
","[{'ForeName': 'Lilas', 'Initials': 'L', 'LastName': 'Ali', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden lilas.ali@gu.se.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallström', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Emmelie', 'Initials': 'E', 'LastName': 'Barenfeld', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fredholm', 'Affiliation': 'Patient representative, The Swedish Heart & Lung Foundation, Stockholm, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gyllensten', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Ekman', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-036356']
1577,32690521,"Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial.","INTRODUCTION


Rheumatoid arthritis (RA) involves changes to foot structure and function, and there is an association between RA and foot pain. This pain affects those patient's physical activity and experience of daily living. While there is clinical evidence for the value of foot orthoses (FO) on foot pain, there is a wide range of FO available and there is little evidence on the relative benefits of one orthoses type over another, especially in terms of their impact on physical activity and associated well-being. The aim of this study is to compare physical activity, general and foot health and foot health experiences in people with RA when wearing three different types of FO.
METHODS AND ANALYSIS


A randomised controlled trial with three arms will compare the effects of (1) custom FO made using a direct adaptation technique, (2) custom FO made through a digital design and production process and (3) prefabricated orthoses. The primary outcome is physical activity measured using a GENEActiv bracelet. Secondary outcomes will be pain, function and disability and associated foot and general health evaluated using existing questionnaires. Semistructured interviews will identify patients' experiences of the orthoses and living with RA.
ETHICS AND DISSEMINATION


The study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee (SPAR-001). The results will be disseminated regardless of the magnitude or direction of effect.
TRIAL REGISTRATION NUMBER


NCT03170947; Pre-results.",2020,"A randomised controlled trial with three arms will compare the effects of (1) custom FO made using a direct adaptation technique, (2) custom FO made through a digital design and production process and (3) prefabricated orthoses.","['people with RA', 'people with rheumatoid arthritis']","['custom FO made using a direct adaptation technique, (2) custom FO made through a digital design and production process and (3) prefabricated orthoses', 'Foot orthoses']","['pain, function and disability and associated foot and general health evaluated using existing questionnaires', 'physical activity', 'physical activity, general and foot health and foot health experiences']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1522240', 'cui_str': 'Process'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",3.0,0.232378,"A randomised controlled trial with three arms will compare the effects of (1) custom FO made using a direct adaptation technique, (2) custom FO made through a digital design and production process and (3) prefabricated orthoses.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ramos-Petersen', 'Affiliation': 'Podiatry, Universidad Catolica San Antonio de Murcia - Campus de los Jeronimos, Murcia, Spain.'}, {'ForeName': 'Christoper J', 'Initials': 'CJ', 'LastName': 'Nester', 'Affiliation': 'University of Salford Faculty of Health and Society, Salford, UK.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gijon-Nogueron', 'Affiliation': 'Nursing and Podiatry, Universidad de Malaga Facultad de Ciencias de la Salud, Malaga, Andalucía, Spain gagijon@uma.es.'}, {'ForeName': 'Ana Belen', 'Initials': 'AB', 'LastName': 'Ortega-Avila', 'Affiliation': 'Nursing and Podiatry, Universidad de Malaga Facultad de Ciencias de la Salud, Malaga, Andalucía, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-036433']
1578,32690523,Study protocol for a 9-month randomised controlled trial assessing the effects of almonds versus carbohydrate-rich snack foods on weight loss and weight maintenance.,"INTRODUCTION


Epidemiological studies indicate an inverse association between nut consumption and body mass index (BMI). However, clinical trials evaluating the effects of nut consumption compared with a nut-free diet on adiposity have reported mixed findings with some studies reporting greater weight loss and others reporting no weight change. This paper describes the rationale and detailed protocol for a randomised controlled trial assessing whether the inclusion of almonds or carbohydrate-rich snacks in an otherwise nut-free energy-restricted diet will promote weight loss during 3 months of energy restriction and limit weight regain during 6 months of weight maintenance.
METHODS AND ANALYSIS


One hundred and thirty-four adults aged 25-65 years with a BMI of 27.5-34.9 kg/m 2  will be recruited and randomly allocated to either the almond-enriched diet (AED) (15% energy from almonds) or a nut-free control diet (NFD) (15% energy from carbohydrate-rich snack foods). Study snack foods will be provided. Weight loss will be achieved through a 30% energy restriction over 3 months, and weight maintenance will be encouraged for 6 months by increasing overall energy intake by ~120-180 kcal/day (~500-750kJ/day) as required. Food will be self-selected, based on recommendations from the study dietitian. Body composition, resting energy expenditure, total daily energy expenditure (via doubly labelled water), physical activity, appetite regulation, cardiometabolic health, gut microbiome, liver health, inflammatory factors, eating behaviours, mood and personality, functional mobility and pain, quality of life and sleep patterns will be measured throughout the 9-month trial. The effects of intervention on the outcome measures over time will be analysed using random effects mixed models, with treatment (AED or NFD) and time (baseline, 3 months and 9 months) being the between and within factors, respectively in the analysis.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the University of South Australia Human Research Ethics Committee (201436). Results from this trial will be disseminated through publication in peer-reviewed journals, national and international presentations.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618001861246).",2020,"Body composition, resting energy expenditure, total daily energy expenditure (via doubly labelled water), physical activity, appetite regulation, cardiometabolic health, gut microbiome, liver health, inflammatory factors, eating behaviours, mood and personality, functional mobility and pain, quality of life and sleep patterns will be measured throughout the 9-month trial.",['One hundred and thirty-four adults aged 25-65 years with a BMI of 27.5-34.9\u2009kg/m 2'],"['almond-enriched diet (AED) (15% energy from almonds) or a nut-free control diet (NFD) (15% energy from carbohydrate-rich snack foods', 'carbohydrate-rich snacks', 'carbohydrate-rich snack foods']","['weight loss', 'weight loss and weight maintenance', 'Body composition, resting energy expenditure, total daily energy expenditure (via doubly labelled water), physical activity, appetite regulation, cardiometabolic health, gut microbiome, liver health, inflammatory factors, eating behaviours, mood and personality, functional mobility and pain, quality of life and sleep patterns', 'Weight loss']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517674', 'cui_str': '27.5'}]","[{'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}]",134.0,0.152979,"Body composition, resting energy expenditure, total daily energy expenditure (via doubly labelled water), physical activity, appetite regulation, cardiometabolic health, gut microbiome, liver health, inflammatory factors, eating behaviours, mood and personality, functional mobility and pain, quality of life and sleep patterns will be measured throughout the 9-month trial.","[{'ForeName': 'Sharayah', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Yandell', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sze-Yen', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Geraint B', 'Initials': 'GB', 'LastName': 'Rogers', 'Affiliation': 'Microbiome Research, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Childs', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Matheson', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lamb', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ward', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tasha R', 'Initials': 'TR', 'LastName': 'Stanton', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Fraysse', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Hills', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Coates', 'Affiliation': 'Allied Health and Human Performance, University of South Australia, Adelaide, South Australia, Australia alison.coates@unisa.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-036542']
1579,32690536,Study protocol for a randomised controlled trial evaluating the effects of the orexin receptor antagonist suvorexant on sleep architecture and delirium in the intensive care unit.,"INTRODUCTION


Insomnia frequently occurs in patients admitted to an intensive care unit (ICU). Sleep-promoting agents may reduce rapid eye movement sleep and have deliriogenic effects. Suvorexant (Belsomra) is an orexin receptor antagonist with Food and Drug Administration (FDA) approval for the treatment of adult insomnia, which improves sleep onset and maintenance as well as subjective measures of quality of sleep. This trial will evaluate the efficacy of postoperative oral suvorexant treatment on night-time wakefulness after persistent sleep onset as well as the incidence and duration of delirium among adult cardiac surgical patients.
METHODS AND ANALYSIS


In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 120 patients, aged 60 years or older, undergoing elective cardiac surgery with planned postoperative admission to the ICU. Participants will be randomised to receive oral suvorexant (20 mg) or placebo one time a day starting the night after extubation. The primary outcome will be wakefulness after persistent sleep onset. The secondary outcome will be total sleep time. Exploratory outcomes will include time to sleep onset, incidence of postoperative in-hospital delirium, number of delirium-free days and subjective sleep quality.
ETHICS AND DISSEMINATION


Ethics approval was obtained through the 'Committee on Clinical Investigations' at Beth Israel Deaconess Medical Center (protocol number 2019P000759). The findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


This trial has been registered at clinicaltrials.gov on 17 September 2019 (NCT04092894).",2020,"This trial will evaluate the efficacy of postoperative oral suvorexant treatment on night-time wakefulness after persistent sleep onset as well as the incidence and duration of delirium among adult cardiac surgical patients.
","['adult cardiac surgical patients', '120 patients, aged 60 years or older, undergoing elective cardiac surgery with planned postoperative admission to the ICU', 'patients admitted to an intensive care unit (ICU']","['oral suvorexant', 'orexin receptor antagonist suvorexant', 'postoperative oral suvorexant treatment', 'placebo']","['total sleep time', 'wakefulness after persistent sleep onset', 'night-time wakefulness', 'sleep architecture and delirium', 'time to sleep onset, incidence of postoperative in-hospital delirium, number of delirium-free days and subjective sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C4019081', 'cui_str': 'Orexin Receptor Blockers'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.584136,"This trial will evaluate the efficacy of postoperative oral suvorexant treatment on night-time wakefulness after persistent sleep onset as well as the incidence and duration of delirium among adult cardiac surgical patients.
","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Azimaraghi', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Hammer', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Santer', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Platzbecker', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Friederike C', 'Initials': 'FC', 'LastName': 'Althoff', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Patrocinio', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Stephanie D', 'Initials': 'SD', 'LastName': 'Grabitz', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Karuna', 'Initials': 'K', 'LastName': 'Wongtangman', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Rumyantsev', 'Affiliation': 'Pharmacy, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Maximilian S', 'Initials': 'MS', 'LastName': 'Schaefer', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Fuller', 'Affiliation': 'Department of Neurology, Program in Neuroscience and Division of Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Eikermann', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA meikerma@bidmc.harvard.edu.'}]",BMJ open,['10.1136/bmjopen-2020-038474']
1580,32696905,Shortening of etching time of the dentin in primary teeth restorations: a randomized clinical trial.,"The aim of this study was to investigate the influence of shortening of etching time for dentin on the restoration survival after selective carious tissue removal in primary molars. This two-arm randomized clinical trial included sixty-two subjects (5-8 year-old) and 100 primary molars presenting moderate dentin carious lesions on occlusal surface. The sample was randomly assigned into groups previously to adhesive application (Adper Single Bond 2; 3M ESPE): etching time recommended by manufacturer (15 s) or reduced (7 s). Resin composite (Filtek Bulk Fill Posterior Restorative; 3M ESPE) was inserted in a single increment for all restorations. Restorations were evaluated at 1, 6, 12, and 18 months using FDI criteria. Survival estimates for restorations' longevity were evaluated with Kaplan-Meier method. Multivariate Cox regression analysis with shared frailty was used to assess the factors associated with failures (p < 0.05). The etching time did not influence the restorations' survival (HR 0.35 95%CI 0.11-1.12; p = 0.06). Mean estimated time of survival was 17.6 months (95%CI, 17.2-17.9). The survival rates at the 18-month follow-up were 75.7% and 91.4% (AFR: 16.9% and 5.7%) when primary dentin was acid etched for 15 and 7 s, respectively (log-rank p = 0.06). In conclusion, the etching time for dentin did not influence the clinical behavior of adhesives restorations. However, there was a tendency for better clinical outcome when using etching time of 7 s.",2020,The etching time did not influence the restorations' survival (HR 0.35 95%CI 0.11-1.12; p = 0.06).,"['sixty-two subjects (5-8 year-old) and 100 primary molars presenting moderate dentin carious lesions on occlusal surface', 'primary molars', 'primary teeth restorations']","['adhesive application (Adper Single Bond 2; 3M ESPE): etching time recommended by manufacturer', 'Resin composite (Filtek Bulk Fill Posterior Restorative; 3M ESPE']","['survival rates', 'Mean estimated time of survival', 'Shortening of etching time', ""restorations' survival"", 'Survival estimates']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0759863', 'cui_str': 'single bond'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C4505780', 'cui_str': 'Filtek Bulk Fill'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",62.0,0.127887,The etching time did not influence the restorations' survival (HR 0.35 95%CI 0.11-1.12; p = 0.06).,"[{'ForeName': 'Cleber Paradzinski', 'Initials': 'CP', 'LastName': 'Cavalheiro', 'Affiliation': 'Dental Science Graduate Program, School of Dentistry, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Pablo Soares de', 'Initials': 'PS', 'LastName': 'Souza', 'Affiliation': 'Departament of Stomatology, School of Dentistry, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Djessica', 'Initials': 'D', 'LastName': 'Pedrotti', 'Affiliation': 'Dental Science Graduate Program, School of Dentistry, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Casagrande', 'Affiliation': 'Post-Graduate Program in Pediatric Dentistry, School of Dentistry, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Thiago Machado', 'Initials': 'TM', 'LastName': 'Ardenghi', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry, School of Dentistry, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Rachel de Oliveira', 'Initials': 'RO', 'LastName': 'Rocha', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry, School of Dentistry, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry, School of Dentistry, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Tathiane Larissa', 'Initials': 'TL', 'LastName': 'Lenzi', 'Affiliation': 'Post-Graduate Program in Pediatric Dentistry, School of Dentistry, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0081']
1581,32696911,Postoperative pain after root canal filling with different endodontic sealers: a randomized clinical trial.,"The aim of this randomized clinical trial was to compare the occurrence and intensity of postoperative pain and analgesic intake after root canal treatment, using different root canal sealers. Sixty single-rooted teeth diagnosed with asymptomatic necrosis and apical periodontitis were randomly assigned to 3 experimental groups (n=20), according to the root canal sealer: AH Plus, Endofill or MTA Fillapex. Endodontic treatment was performed in two sessions, and calcium hydroxide was used as the intracanal dressing. Patients were instructed to record pain intensity as none, slight, moderate and severe. Scores from 1 to 4 were attributed to each level of pain after 24 h, 48 h and 7 days. The need for analgesic intake was also recorded. Differences in the incidence of postoperative pain and the need for an analgesic were analyzed using the chi-square test. Differences in pain intensity after treatment were analyzed using the ordinal (linear) chi-square test. No significant differences were detected among the groups in terms of either incidence or intensity of postoperative pain, or need for analgesic intake, at any timepoint (p>0.05). No pain was reported after 7 days. AH Plus, Endofill and MTA Fillapex used for filling root canals resulted in the same rate of postoperative pain and need for analgesic medication.",2020,"No significant differences were detected among the groups in terms of either incidence or intensity of postoperative pain, or need for analgesic intake, at any timepoint (p>0.05).",['Sixty single-rooted teeth diagnosed with asymptomatic necrosis and apical periodontitis'],"['root canal sealer: AH Plus, Endofill or MTA Fillapex', 'Endofill and MTA Fillapex', 'calcium hydroxide', 'AH']","['postoperative pain and need for analgesic medication', 'pain intensity', 'postoperative pain', 'analgesic intake', 'incidence or intensity of postoperative pain, or need for analgesic intake', 'occurrence and intensity of postoperative pain and analgesic intake', 'pain', 'Postoperative pain']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0167863', 'cui_str': 'Endo-Fill'}, {'cui': 'C3852787', 'cui_str': 'MTA-Fillapex'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.139671,"No significant differences were detected among the groups in terms of either incidence or intensity of postoperative pain, or need for analgesic intake, at any timepoint (p>0.05).","[{'ForeName': 'Nadia de Souza', 'Initials': 'NS', 'LastName': 'Ferreira', 'Affiliation': 'Department of Semiology and Clinics, School of Dentistry, Universidade Federal de Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Elisa Korte Fortes', 'Initials': 'EKF', 'LastName': 'Gollo', 'Affiliation': 'School of Dentistry, Universidade Federal de Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Noeli', 'Initials': 'N', 'LastName': 'Boscato', 'Affiliation': 'Department of Restorative Dentsitry, School of Dentistry, Universidade Federal de Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arias', 'Affiliation': 'Conservative Dentistry Department, School of Dentistry, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Emmanuel João Nogueira Leal da', 'Initials': 'EJNLD', 'LastName': 'Silva', 'Affiliation': 'Endodontics Department, School of Dentistry, Universidade do Grande Rio, Rio de Janeiro, RJ, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0069']
1582,32696964,The Evidence-Based Sexual Abuse Prevention Program: Strong With Sam.,"The present study was initiated to design and evaluate a sexual abuse prevention program for deaf and hard of hearing (DHH) children. This evidence-based prevention program is the first of its kind for DHH children. A total of 92 DHH children aged 8-12 years participated in the program ""STARK mit SAM"" (Strong with Sam, SmS), a program conducted in primary schools for DHH children in Germany. The program evaluation consisted of a pretest-posttest design. As per class, the subjects were assigned to either the experimental or the wait list control group. Participants from both groups were pretested for their knowledge about content related to the prevention of sexual abuse. The experimental group received the prevention program and both groups were posttested to examine the effects of the program. Additionally, the experimental group was tested again 6 months after the program. DHH children who participated in the SmS program showed a significant knowledge gain and a nonsignificant change in their anxiety. No significant factor affecting the children's significant knowledge gain was found. SmS is an effective sexual abuse prevention program for DHH children, which can be offered without incurring anxiety in the children.",2020,"SmS is an effective sexual abuse prevention program for DHH children, which can be offered without incurring anxiety in the children.","['DHH children who participated in the SmS program', 'DHH children', '92 DHH children aged 8-12\xa0years participated in the', 'DHH children in Germany', 'sexual abuse prevention program for deaf and hard of hearing (DHH) children']","['prevention program', 'program ""STARK mit SAM"" (Strong with Sam, SmS', 'SmS']","['knowledge gain', 'anxiety']","[{'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0018772', 'cui_str': 'Partial deafness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",92.0,0.0164724,"SmS is an effective sexual abuse prevention program for DHH children, which can be offered without incurring anxiety in the children.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Urbann', 'Affiliation': 'Faculty of Human Sciences, Education and Rehabilitation of the Deaf and the Hard of Hearing, University of Cologne.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Bienstein', 'Affiliation': 'TU Dortmund University, Faculty of Rehabilitation Sciences, Rehabilitation and Education: Intellectual Disabilities.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kaul', 'Affiliation': 'Faculty of Human Sciences, Education and Rehabilitation of the Deaf and the Hard of Hearing, University of Cologne.'}]",Journal of deaf studies and deaf education,['10.1093/deafed/enaa019']
1583,32699126,Barriers and facilitators to uptake and retention of inner-city ethnically diverse women in a postnatal weight management intervention: a mixed-methods process evaluation within a feasibility trial in England.,"OBJECTIVES


To understand the barriers and facilitators to uptake and retention of postnatal women randomised to a commercial group weight management intervention using the COM-B (capability, opportunity, motivation and behaviour) behaviour change model.
DESIGN


Concurrent mixed-methods (qualitative dominant) process evaluation nested within a feasibility randomised controlled trial, comprising questionnaires and interviews at 6 and 12 months postbirth.
SETTING


One National Health Service maternity unit in an inner city area in the south of England.
PARTICIPANTS


98 postnatal women with body mass indices>25 kg/m 2  (overweight/obese) at pregnancy commencement.
INTERVENTION


Twelve-week Slimming World (SW) commercial group weight management programme, commencing anytime from 8 to 16 weeks postnatally.
PRIMARY AND SECONDARY OUTCOME MEASURES


Data regarding uptake and retention from questionnaires and interviews conducted 6 and 12 months postbirth analysed thematically and mapped to the COM-B model.
RESULTS


Barriers to SW uptake mostly concerned opportunity issues (eg, lack of time or childcare support) though some women also lacked motivation, not feeling that weight reduction was a priority, and a few cited capability issues such as lacking confidence. Weight loss aspirations were also a key factor explaining retention, as were social opportunity issues, particularly in relation to factors such as the extent of group identity and relationship with the group consultant; and physical opportunity such as perceived support from and fit with family lifestyle. In addition, barriers relating to beliefs and expectations about the SW programme were identified, including concerns regarding compatibility with breastfeeding and importance of exercise. Women's understanding of the SW approach, and capability to implement into their lifestyles, appeared related to level of attendance (dose-response effect).
CONCLUSIONS


Uptake and retention in commercial weight management programmes may be enhanced by applying behaviour change techniques to address the barriers impacting on women's perceived capability, motivation and opportunity to participate.
TRIAL REGISTRATION NUMBER


ISRCTN39186148.",2020,"Weight loss aspirations were also a key factor explaining retention, as were social opportunity issues, particularly in relation to factors such as the extent of group identity and relationship with the group consultant; and physical opportunity such as perceived support from and fit with family lifestyle.","['One National Health Service maternity unit in an inner city area in the south of England', '98 postnatal women with body mass indices>25 kg/m 2  (overweight/obese) at pregnancy commencement']","['postnatal weight management intervention', 'commercial group weight management intervention']","['COM-B (capability, opportunity, motivation and behaviour) behaviour change model']","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009490', 'cui_str': 'Comoros islands'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",98.0,0.0765417,"Weight loss aspirations were also a key factor explaining retention, as were social opportunity issues, particularly in relation to factors such as the extent of group identity and relationship with the group consultant; and physical opportunity such as perceived support from and fit with family lifestyle.","[{'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'School of Health Sciences, University of Surrey, Guildford, UK cath.taylor@surrey.ac.uk.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Bhavnani', 'Affiliation': 'National Childbirth Trust, London, UK.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Zasada', 'Affiliation': 'School of Health Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, West Midlands, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034747']
1584,32699128,Early Parenting Intervention - Biobehavioral Outcomes in infants with Neurodevelopmental Disabilities (EPI-BOND): study protocol for an Italian multicentre randomised controlled trial.,"INTRODUCTION


Neurodevelopmental disability (ND) represents an adverse condition for infants' socio-emotional and behavioural development as well as for caregiving (eg, parental sensitivity) and mother-infant interaction. Adverse exposures are associated with altered neuroendocrine hormones concentrations (eg, oxytocin and cortisol) and epigenetic regulation (eg, methylation of stress-related genes), which in turn may contribute to less-than-optimal mother-infant interaction. Parental sensitivity is a protective factor for childrens' development and early parental interventions (eg, video-feedback intervention) can promote parental caregiving and better developmental outcomes in children. The present multi-centric and longitudinal randomised controlled trial aims to assess if and to which extent early VFI could benefit both infants and mothers in terms of behavioural outcomes as well as neuroendocrine and epigenetic regulation.
METHODS AND ANALYSIS


Dyads will be randomly assigned to the video-feedback Intervention Group or Control Group ('dummy' intervention: telephone calls). Infants with ND aged 3 to 18 months will be recruited from three major child neuropsychiatric units in northern Italy. A multi-layer approach to intervention effects will include videotapes of mother-infant interaction, maternal reports as well as saliva samples for hormones concentrations and target-gene methylation analysis (eg,  BDNF ,  NR3C1 ,  OXTR and SCL6A4 ) that will be obtained at each of the four assessment sessions: T 0 , baseline; T 1 , post-intervention; T 2 , short-term follow-up (3 month); T 3 , long-term follow-up (6 month). Primary effectiveness measures will be infant socio-emotional behaviour and maternal sensitivity. Neuroendocrine hormones concentrations and DNA methylation status of target genes will be secondary outcomes. Feasibility, moderation and confounding variables will be measured and controlled between the two groups.
ETHICS AND DISSEMINATION


Ethics approval has been obtained in all three participating units. Results of the main trial and each of the secondary endpoints will be submitted for publication in peer-reviewed journals and international conferences.
TRIAL REGISTRATION NUMBER


NCT03853564; Pre-results.",2020,"Parental sensitivity is a protective factor for childrens' development and early parental interventions (eg, video-feedback intervention) can promote parental caregiving and better developmental outcomes in children.","['children', 'Infants with ND aged 3 to 18 months will be recruited from three major child neuropsychiatric units in northern Italy', 'infants with Neurodevelopmental Disabilities (EPI-BOND']","[""video-feedback Intervention Group or Control Group ('dummy' intervention: telephone calls""]",['infant socio-emotional behaviour and maternal sensitivity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.22658,"Parental sensitivity is a protective factor for childrens' development and early parental interventions (eg, video-feedback intervention) can promote parental caregiving and better developmental outcomes in children.","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Montirosso', 'Affiliation': '0-3 Center for the at-Risk Infant, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy rosario.montirosso@lanostrafamiglia.it.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rosa', 'Affiliation': '0-3 Center for the at-Risk Infant, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giorda', 'Affiliation': 'Biology Lab, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Fazzi', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Orcesi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cavallini', 'Affiliation': 'Neuropsychiatry and Neurorehabilitation Unit, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Provenzi', 'Affiliation': 'Child Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035249']
1585,32699168,"Randomised, cOntrolled Multicentre trial of 26 weeks subcutaneous liraglutide (a glucagon-like peptide-1 receptor Agonist), with or without contiNuous positive airway pressure (CPAP), in patients with type 2 diabetes mellitus (T2DM) and obstructive sleep apnoEa (OSA) (ROMANCE): study protocol assessing the effects of weight loss on the apnea-hypnoea index (AHI).","INTRODUCTION


Obstructive sleep apnoea (OSA) and type 2 diabetes mellitus (T2DM) often occur concurrently, and untreated OSA may potentially amplify the high risk of cardiovascular disease in T2DM. Compliance with continuous positive airway pressure (CPAP), the conventional treatment for OSA, can be poor and considering weight loss is the most effective treatment for OSA. This trial examines whether the glucagon-like peptide-1 receptor agonist liraglutide, a glucose-lowering therapy associated with significant weight loss used in T2DM, can improve the severity and symptoms of OSA.
METHODS AND ANALYSIS


This is an outpatient, single-centred, open-labelled, prospective, phase IV randomised controlled trial in a two-by-two factorial design. One hundred and thirty-two patients with newly diagnosed OSA (apnoea-hypopnoea index (AHI) ≥15 events/hour), and existing obesity and T2DM (glycated haemoglobin (HbA 1c ) ≥47 mmol/mol), will be recruited from diabetes and sleep medicine outpatient clinics in primary and secondary care settings across Liverpool. Patients will be allocated equally, using computer-generated random, permuted blocks of unequal sizes, to each of the four treatment arms for 26 weeks: (i) liraglutide (1.8 mg once per day) alone, (ii) liraglutide 1.8 mg once per day with CPAP, (iii) CPAP alone (conventional care) or (iv) no treatment (control). The primary outcome measure is change in OSA severity, determined by AHI. Secondary outcome measures include effects on glycaemic control (glycated haemoglobin (HbA1c)), body weight and quality of life measures. Exploratory measures include measures of physical activity, MRI-derived measures of regional body composition including fat mass (abdominal subcutaneous, visceral, neck and liver fat) and skeletal muscle mass (cross-sectional analysis of thigh), indices of cardiac function (using transthoracic echocardiography) and endothelial function.
ETHICAL APPROVAL


The study has been approved by the North West Liverpool Central Research Ethics Committee (14/NW/1019) and it is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
TRIAL REGISTRATION NUMBERS


ISRCTN16250774. EUDRACT No. 2014-000988-41. UTN U1111-1139-0677.",2020,"Secondary outcome measures include effects on glycaemic control (glycated haemoglobin (HbA1c)), body weight and quality of life measures.","['One hundred and thirty-two patients with newly diagnosed OSA (apnoea-hypopnoea index (AHI) ≥15 events/hour), and existing obesity and T2DM (glycated haemoglobin (HbA 1c ) ≥47\u2009mmol/mol), will be recruited from diabetes and sleep medicine outpatient clinics in primary and secondary care settings across Liverpool', 'patients with type 2 diabetes mellitus (T2DM) and obstructive sleep apnoEa (OSA) (ROMANCE']","['UTN', 'liraglutide (a glucagon-like peptide-1 receptor Agonist), with or without contiNuous positive airway pressure (CPAP', 'liraglutide 1.8\u2009mg once per day with CPAP, (iii) CPAP alone (conventional care) or (iv) no treatment (control', 'liraglutide', 'glucagon-like peptide-1 receptor agonist liraglutide', 'continuous positive airway pressure (CPAP']","['apnea-hypnoea index (AHI', 'glycaemic control (glycated haemoglobin (HbA1c)), body weight and quality of life measures', 'physical activity, MRI-derived measures of regional body composition including fat mass (abdominal subcutaneous, visceral, neck and liver fat) and skeletal muscle mass (cross-sectional analysis of thigh), indices of cardiac function (using transthoracic echocardiography) and endothelial function', 'change in OSA severity, determined by AHI']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4304028', 'cui_str': 'Sleep medicine specialist'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}]",132.0,0.0452433,"Secondary outcome measures include effects on glycaemic control (glycated haemoglobin (HbA1c)), body weight and quality of life measures.","[{'ForeName': 'Victoria S', 'Initials': 'VS', 'LastName': 'Sprung', 'Affiliation': 'Research Institute for Sport & Exercise Sciences, Liverpool John Moores University, Liverpool, UK v.s.sprung@ljmu.ac.uk.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Kemp', 'Affiliation': 'Department of Musculoskeletal & Ageing Science, University of Liverpool, Liverpool, Merseyside, UK.'}, {'ForeName': 'John Ph', 'Initials': 'JP', 'LastName': 'Wilding', 'Affiliation': 'Department of Cardiovascular & Metabolic Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Adams', 'Affiliation': 'Liverpool Magnetic Resonance Imaging Centre (LiMRIC), University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Liverpool Magnetic Resonance Imaging Centre (LiMRIC), University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Burgess', 'Affiliation': 'Department of Cardiology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Emegbo', 'Affiliation': 'Liverpool Sleep & Ventilation Unit, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Liverpool Sleep & Ventilation Unit, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Needham', 'Affiliation': 'Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weimken', 'Affiliation': 'Center for Sleep & Circadian Neurobiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Schwab', 'Affiliation': 'Center for Sleep & Circadian Neurobiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Manuel', 'Affiliation': 'Liverpool Sleep & Ventilation Unit, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Sonya E', 'Initials': 'SE', 'LastName': 'Craig', 'Affiliation': 'Liverpool Sleep & Ventilation Unit, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cuthbertson', 'Affiliation': 'Department of Cardiovascular & Metabolic Medicine, University of Liverpool, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2020-038856']
1586,32690591,Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE).,"BACKGROUND


Observational studies have supported the practice of offering minimally invasive interval debulking surgery after neoadjuvant chemotherapy for well-selected patients with advanced epithelial ovarian cancer. However, there are no prospective randomized data comparing the oncologic efficacy of minimally invasive and open interval debulking surgery in epithelial ovarian cancer.
PRIMARY OBJECTIVE


The primary objective of this study is to examine whether minimally invasive surgery is non-inferior to laparotomy in terms of disease-free survival in women with advanced stage epithelial ovarian cancer that responded to three or four cycles of neoadjuvant chemotherapy.
STUDY HYPOTHESIS


We hypothesize that in patients who had a complete or partial response to neoadjuvant chemotherapy, minimally invasive interval debulking surgery is not inferior to laparotomy.
TRIAL DESIGN


The Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE) trial is an international, prospective, randomized, multicenter, non-inferiority phase III trial to compare minimally invasive surgery vs laparotomy in women with advanced stage high-grade epithelial ovarian cancer that had a complete or partial response to three or four cycles of neoadjuvant chemotherapy and normalization of CA-125. The first 100 participants will be enrolled into a pilot lead-in to determine feasibility. The study will be considered feasible and will continue to Phase III under the following conditions: the accrual rate reaches at least 80% of the target rate after all pilot sites are open; the crossover rate in the minimally invasive group is less than 25%; and the difference of complete gross resection between the minimally invasive and open group is less than 20%. If the study is determined to be feasible, all remaining participants will be enrolled into the Phase III stage.
MAJOR INCLUSION/EXCLUSION CRITERIA


Patients with stage IIIC or IV high-grade epithelial ovarian, primary peritoneal or fallopian tube carcinoma who had a complete or partial response to three or four cycles of neoadjuvant chemotherapy based on imaging and normalization of CA-125 will be enrolled. Patients with evidence of tumor not amenable to minimally invasive resection on pre-operative imaging will be excluded.
PRIMARY ENDPOINT


The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.
SAMPLE SIZE


To demonstrate non-inferiority with a margin of 33% in the hazard ratio (HR=1.33), 549 patients will be randomized.",2020,"The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.
","['100 participants', 'women with advanced stage high-grade epithelial ovarian cancer that had a complete or partial response to three or four cycles of neoadjuvant chemotherapy and normalization of CA-125', 'patients who had a complete or partial response to neoadjuvant chemotherapy, minimally invasive interval debulking surgery is not inferior to laparotomy', '549 patients will be randomized', 'women with advanced stage epithelial ovarian cancer', 'patients with advanced epithelial ovarian cancer', 'Patients with stage IIIC or IV high-grade epithelial ovarian, primary peritoneal or fallopian tube carcinoma who had a complete or partial response to three or four cycles of neoadjuvant chemotherapy based on imaging and normalization of CA-125 will be enrolled']","['minimally invasive and open interval debulking surgery', 'Laparoscopic cytoreduction', 'Neoadjuvant ChEmotherapy (LANCE', 'minimally invasive surgery', 'minimally invasive interval debulking surgery after neoadjuvant chemotherapy', 'minimally invasive surgery vs laparotomy', 'neoadjuvant chemotherapy']",['non-inferiority of disease-free survival'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",549.0,0.355422,"The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.
","[{'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Nitecki', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jose Alejandro', 'Initials': 'JA', 'LastName': 'Rauh-Hain', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA jarauh@mdanderson.org.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Melamed', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': ""Department of Women's and Children's Health, Policlinico A Gemelli, Rome, Italy.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': 'Instituto Nacional de Cancerología, Bogotá, and Clínica de Oncología Astorga, Medellin, Colombia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The US Oncology Network, The Woodlands, Texas, USA.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': ""Department of Women's and Children's Health, Policlinico A Gemelli, Rome, Italy.""}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001584']
1587,32690725,"Correction:  Effects of programmed intermittent thoracic paravertebral bolus of levobupivacaine on the spread of sensory block: a randomized, controlled, double-blind study .",,2020,,[],['levobupivacaine'],['spread of sensory block'],[],"[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.431649,,[],Regional anesthesia and pain medicine,['10.1136/rapm-2018-100021corr1']
1588,32690730,Identifying significant contributors for smoking cessation among male prisoners in Australia: results from a randomised clinical trial.,"INTRODUCTION


In Australia, an estimated 90% of those entering prison are current tobacco smokers and three-quarters of current prisoners are tobacco smokers.
AIMS


To identify factors and their relative contributions to smoking cessation among male prisoners.
METHODS


A total of 425 male tobacco smokers with a median age of 32 years in Australian prisons. The primary outcome was continuous abstinence at 3, 6 and 12 months. We measured various sociodemographic characteristics, drug use, psychological distress and the mental and physical health status of the participants. Multivariate logistic regression models and population attributable risks (PAR%) were used to identify the significant factors and their contributions to smoking cessation rates.
RESULTS


The median age of participants was 32 years (IQR 25-41 years). High smoking cessation rates were collectively associated with not using drugs, lower psychological distress, good mental health scores and better physical health (PAR%: 93%, 98% and 88% at 3, 6 and 12 months).
CONCLUSION


Our study suggests that not using drugs and being in good mental/physical health are the important contributors to continuous abstinence among prisoners. Thus, effective smoking cessation programmes require a multicomponent approach that includes addressing drug problems and mental health functioning.
TRIAL REGISTRATION NUMBER


12606000229572.",2020,"High smoking cessation rates were collectively associated with not using drugs, lower psychological distress, good mental health scores and better physical health (PAR%: 93%, 98% and 88% at 3, 6 and 12 months).
","['425 male tobacco smokers with a median age of 32 years in Australian prisons', 'male prisoners', 'male prisoners in Australia']",[],"['psychological distress, good mental health scores and better physical health', 'continuous abstinence', 'High smoking cessation rates', 'various sociodemographic characteristics, drug use, psychological distress and the mental and physical health status']","[{'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",425.0,0.0559297,"High smoking cessation rates were collectively associated with not using drugs, lower psychological distress, good mental health scores and better physical health (PAR%: 93%, 98% and 88% at 3, 6 and 12 months).
","[{'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Wand', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Richmond', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Armita', 'Initials': 'A', 'LastName': 'Adily', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Le', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Wilhelm', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australila.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Butler', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia tbutler@kirby.unsw.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034046']
1589,32696178,Effect of weight-loss diet combined with taurine supplementation on body composition and some biochemical markers in obese women: a randomized clinical trial.,"Taurine (Tau), an endogenous non-protein and sulfuric-amino acid, is involved in various biological pathways including anti-inflammatory, anti-oxidation, insulin resistance inhibition, and lipid profile improvement. According to some experimental and clinical studies, insulin resistance and excess body weight are associated with reduced serum level of Tau. Therefore, this study was aimed to evaluate Tau supplementation and a diet-induced weight-loss intervention on body composition and some biochemical indices of obese women. Participants were divided randomly into the intervention (standard weight-loss group + cap Tau 3 g/day for 8 weeks, n = 20) and control (standard weight-loss group + cap placebo for 8 weeks, n = 18) groups. To achieve weight loss, all participants received an individualized diet that included a 30% reduction in their total energy intake. Chi-square test was applied to compare categorical variables between two groups at baseline. Paired t test and independent-sample t test were also used to analyze the parametric continuous data within and between the two groups, respectively. Analysis of covariance was run for controlling the confounding variables. At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group. No significant results were found in the mean changes of high-density lipoprotein cholesterol, anthropometric measurements, glycemic indices, and liver enzymes between the two groups (p > 0.05). The findings showed that Tau supplementation along with a weight-loss diet may be more effective in improving the lipid profile and metabolic risk factors compared with a weight-loss diet alone.",2020,"At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group.",['obese women'],"['Tau supplementation and a diet-induced weight-loss intervention', 'weight-loss diet combined with taurine supplementation', 'Taurine (Tau', 'intervention (standard weight-loss group\u2009+\u2009cap Tau 3 g/day for 8\xa0weeks, n\u2009=\u200920) and control (standard weight-loss group\u2009+\u2009cap placebo']","['high sensitivity C-reactive protein', 'leptin', 'low-density lipoprotein cholesterol', 'body composition', 'total adiponectin', 'weight loss', 'mean changes of high-density lipoprotein cholesterol, anthropometric measurements, glycemic indices, and liver enzymes', 'lipid profile and metabolic risk factors', 'mean changes of total cholesterol']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0281008,"At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Asadi', 'Affiliation': 'Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. maryamasadi136@gmail.com.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Mohammadi-Asl', 'Affiliation': 'Department of Medical Genetics, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Amino acids,['10.1007/s00726-020-02876-7']
1590,32693930,"Reply to Emre Karabay and İlker Tınay's Letter to the Editor re: Treatment of High-grade Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial ""NIMBUS"". Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.04.066.",,2020,,[],['BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations'],[],[],"[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",[],,0.0614359,,"[{'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, University Hospital of Jena, Jena, Germany. Electronic address: marc-oliver.grimm@med.uni-jena.de.'}, {'ForeName': 'Christien', 'Initials': 'C', 'LastName': 'Caris', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': 'Wim P J', 'Initials': 'WPJ', 'LastName': 'Witjes', 'Affiliation': 'EAU Research Foundation, Arnhem, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.07.004']
1591,32700098,"Suspension training vs. traditional resistance training: effects on muscle mass, strength and functional performance in older adults.","PURPOSE


We compared the effects of suspension training (ST) with traditional resistance training (TRT) on muscle mass, strength and functional performance in older adults.
METHODS


Forty-two untrained older adults were randomized in TRT, ST (both performed 3 sets of whole body exercises to muscle failure) or control group (CON). Muscle thickness (MT) of biceps brachii (MT BB ) and vastus lateralis (MT VL ), maximal dynamic strength test (1RM) for biceps curl (1RM BC ) and leg extension exercises (1RM LE ), and functional performance tests (chair stand [CS], timed up and go [TUG] and maximal gait speed [MGS]) were performed before and after 12 weeks of training.
RESULTS


MT BB  increased significantly and similarly for all training groups (TRT 23.35%; ST 21.56%). MT VL  increased significantly and similarly for all training groups (TRT 13.03%; ST 14.07%). 1RM BC  increased significantly and similarly for all training groups (TRT 16.06%; ST 14.33%). 1RM LE  increased significantly and similarly for all training groups (TRT 14.89%; ST 18.06%). MGS increased significantly and similarly for all groups (TRT 6.26%; ST 5.99%; CON 2.87%). CS decreased significantly and similarly for all training groups (TRT - 20.80%; ST - 15.73%). TUG decreased significantly and similarly for all training groups (TRT - 8.66%; ST - 9.16%).
CONCLUSION


Suspension training (ST) promotes similar muscle mass, strength and functional performance improvements compared to TRT in older adults.",2020,1RM BC  increased significantly and similarly for all training groups (TRT 16.06%; ST 14.33%).,"['Forty-two untrained older adults', 'older adults']","['Suspension training vs. traditional resistance training', 'suspension training (ST) with traditional resistance training (TRT', 'TRT, ST (both performed 3 sets of whole body exercises to muscle failure) or control group (CON', 'Suspension training (ST']","['MGS', 'TUG', '1RM BC', 'CS', 'MT BB', 'Muscle thickness (MT) of biceps brachii (MT BB ) and vastus lateralis (MT VL ), maximal dynamic strength test (1RM) for biceps curl (1RM BC ) and leg extension exercises (1RM LE ), and functional performance tests (chair stand [CS], timed up and go [TUG] and maximal gait speed [MGS', '1RM LE', 'muscle mass, strength and functional performance', 'MT VL']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",42.0,0.0105798,1RM BC  increased significantly and similarly for all training groups (TRT 16.06%; ST 14.33%).,"[{'ForeName': 'Samuel Domingos', 'Initials': 'SD', 'LastName': 'Soligon', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Deivid Gomes', 'Initials': 'DG', 'LastName': 'da Silva', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'João Guilherme Almeida', 'Initials': 'JGA', 'LastName': 'Bergamasco', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Angleri', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Ricardo Alessandro Medalha', 'Initials': 'RAM', 'LastName': 'Júnior', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Nathalia Fernanda', 'Initials': 'NF', 'LastName': 'Dias', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Sanmy Rocha', 'Initials': 'SR', 'LastName': 'Nóbrega', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'de Castro Cesar', 'Affiliation': 'Department of Medicine, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Cleiton Augusto', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil. c.libardi@ufscar.br.'}]",European journal of applied physiology,['10.1007/s00421-020-04446-x']
1592,32702699,Brain Imaging Signs and Health-Related Quality of Life after Acute Ischemic Stroke: Analysis of ENCHANTED Alteplase Dose Arm.,"BACKGROUND AND PURPOSE


The influence of specific brain lesions on health-related quality of life (HRQoL) after acute ischemic stroke (AIS) is uncertain. We aimed to identify imaging predictors of poor HRQoL in alteplase-treated participants of the alteplase dose arm of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS


ENCHANTED was an international trial of low- versus standard-dose intravenous alteplase in AIS patients, with functional outcome (modified Rankin scale [mRS]) and HRQoL on the 5-dimension European Quality of Life Scale (EQ-5D) assessed at 90 days post-randomization. Brain images were analyzed centrally by trained assessors. Multivariable logistic regression was undertaken in the study population randomly divided (2:1) into training (development) and validation (performance) groups, with age (per 10-year increase), ethnicity, baseline National Institutes of Health Stroke Scale (NIHSS) score, diabetes mellitus, premorbid function (mRS score 0 or 1), and proxy respondent, forced into all models. Data are presented with odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS


Eight prediction models were developed and validated in 2,526 AIS patients (median age 67.5 years; 38.4% female; 61.7% Asian) with complete brain imaging and 90-day EQ-5D utility score data. The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions. Several background features of brain frailty - atrophy, white matter change, and old infarcts - were significantly associated with adverse physical but not emotional HRQoL domains.
CONCLUSIONS


In thrombolysed AIS patients, right-sided and deep ischemia within the MCA territory predict poor overall HRQoL, whilst features of old cerebral ischemia are associated with reduced physical HRQoL.",2020,"The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions.","['2,526 AIS patients (median age 67.5 years; 38.4% female; 61.7% Asian) with', 'after Acute Ischemic Stroke']",['low- versus standard-dose intravenous alteplase'],"['health-related quality of life (HRQoL', 'right-sided and deep ischemia', 'Health Stroke Scale (NIHSS', 'score, diabetes mellitus', 'functional outcome (modified Rankin scale [mRS]) and HRQoL on the 5-dimension European Quality of Life Scale (EQ-5D', 'physical HRQoL', 'complete brain imaging and 90-day EQ-5D utility score data', 'acute ischemic changes', 'Brain Imaging Signs and Health-Related Quality of Life', 'premorbid function (mRS score 0 or 1), and proxy respondent']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]",2526.0,0.097416,"The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions.","[{'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'The George Institute China at Peking University Health Science Centre, Beijing, China.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Torii-Yoshimura', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia, canderson@george.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000509226']
1593,32703634,A Randomised Controlled Trial Assessing the Effects of Peri-operative Fenofibrate Administration on Abdominal Aortic Aneurysm Pathology: Outcomes From the FAME Trial.,"OBJECTIVE


Experimental studies suggest that fenofibrate prevents abdominal aortic aneurysm (AAA) development by lowering aortic osteopontin (OPN) concentration and reducing the number of macrophages infiltrating the aortic wall. The current study examined the effects of a short course of fenofibrate on AAA pathology in people with large AAAs awaiting aortic repair.
METHODS


This randomised double blind parallel trial included male and female participants aged ≥ 60 years who had an asymptomatic AAA measuring ≥ 50 mm and were scheduled to undergo open AAA repair. Participants were allocated to fenofibrate (145 mg/day) or matching placebo for at least two weeks before elective AAA repair. Blood samples were collected at recruitment and immediately prior to surgery. AAA biopsies were obtained during aortic surgery. The primary outcomes were (1) AAA OPN concentration; (2) serum OPN concentration; and (3) number of AAA macrophages. Exploratory outcomes included circulating and aortic concentrations of other proteins previously associated with AAA. Outcomes assessed at a single time point were compared using logistic regression. Longitudinal outcomes were compared using linear mixed effects models.
RESULTS


Forty-three participants were randomised. After three withdrawals, 40 were followed until the time of surgery (21 allocated fenofibrate and 19 allocated placebo). As expected, serum triglycerides reduced significantly from recruitment to the time of surgery in participants allocated fenofibrate. No differences in any of the primary and exploratory outcomes were observed between groups.
CONCLUSION


A short course of 145 mg of fenofibrate/day did not lower concentrations of OPN or aortic macrophage density in people with large AAAs.",2020,A short course of 145 mg of fenofibrate/day did not lower concentrations of OPN or aortic macrophage density in people with large AAAs.,"['Forty-three participants were randomised', 'people with large AAAs', 'male and female participants aged ≥ 60 years who had an asymptomatic AAA measuring ≥ 50\xa0mm and were scheduled to undergo open AAA repair', 'people with large AAAs awaiting aortic repair', 'Abdominal Aortic Aneurysm Pathology']","['fenofibrate and 19 allocated placebo', 'fenofibrate', 'Peri-operative Fenofibrate Administration', 'matching placebo']","['serum triglycerides', 'Blood samples', 'AAA OPN concentration; (2) serum OPN concentration; and (3) number of AAA macrophages', 'concentrations of OPN or aortic macrophage density', 'circulating and aortic concentrations of other proteins previously associated with AAA']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0271742', 'cui_str': 'Glucocorticoid deficiency with achalasia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450400', 'cui_str': '50mm'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0741152', 'cui_str': 'Repair of aneurysm of abdominal aorta'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",43.0,0.5654,A short course of 145 mg of fenofibrate/day did not lower concentrations of OPN or aortic macrophage density in people with large AAAs.,"[{'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Moxon', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Centre for Molecular Therapeutics, The Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Rowbotham', 'Affiliation': ""The University of Queensland, UQ Centre for Clinical Research, Herston, Queensland, Australia; Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Jenna L', 'Initials': 'JL', 'LastName': 'Pinchbeck', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Lazzaroni', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Morton', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Moran', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Quigley', 'Affiliation': 'Mater Medical Centre, Pimlico, Queensland, Australia.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Jenkins', 'Affiliation': ""Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia; School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Cavaye', 'Affiliation': ""St Vincent's Private Hospital Northside, Chermside, Queensland, Australia.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Jaeggi', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'The Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Centre for Molecular Therapeutics, The Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia; Department of Vascular and Endovascular Surgery, Townsville University Hospital, Townsville, Queensland, Australia. Electronic address: jonathan.golledge@jcu.edu.au.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.06.006']
1594,32706635,Randomized Phase III Trial of Pegvorhyaluronidase Alfa With Nab-Paclitaxel Plus Gemcitabine for Patients With Hyaluronan-High Metastatic Pancreatic Adenocarcinoma.,"PURPOSE


To evaluate the efficacy and safety of pegvorhyaluronidase alfa (PEGPH20) plus nab-paclitaxel/gemcitabine (AG) in patients with hyaluronan-high metastatic pancreatic ductal adenocarcinoma (PDA).
PATIENTS AND METHODS


HALO 109-301 was a phase III, randomized, double-blind, placebo-controlled study. Patients ≥ 18 years of age with untreated, metastatic, hyaluronan-high PDA were randomly assigned 2:1 to PEGPH20 plus AG or placebo plus AG. Treatment was administered intravenously in 4-week cycles (3 weeks on, 1 week off) until progression or intolerable adverse events: PEGPH20 3.0 µg/kg twice per week for cycle 1 and once per week thereafter; nab-paclitaxel 125 mg/m 2  once per week; and gemcitabine 1,000 mg/m 2  once per week. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. Response was independently assessed per RECIST v1.1.
RESULTS


At data cutoff, 494 patients were randomly assigned, with 492 (327 for PEGPH20 and 165 for placebo) included in intention-to-treat analyses. Baseline characteristics were balanced for PEGPH20 plus AG versus placebo plus AG. There were 330 deaths, with a median OS of 11.2 months for PEGPH20 plus AG versus 11.5 months for placebo plus AG (hazard ratio [HR], 1.00; 95% CI, 0.80 to 1.27;  P  = .97); median PFS was 7.1 months versus 7.1 months (HR, 0.97 [95% CI, 0.75 to 1.26]); ORR was 47% versus 36% (ORR ratio, 1.29 [95% CI, 1.03 to 1.63]). Grade ≥ 3 adverse events with a ≥ 2% higher rate with PEGPH20 plus AG than with placebo plus AG included fatigue (16.0%  v  9.6%), muscle spasms (6.5%  v  0.6%), and hyponatremia (8.0%  v  3.8%).
CONCLUSION


The addition of PEGPH20 to AG increased the ORR but did not improve OS or PFS. The safety profile of PEGPH20 plus AG was consistent with that found in previous studies. These results do not support additional development of PEGPH20 in metastatic PDA.",2020,"Grade ≥ 3 adverse events with a ≥ 2% higher rate with PEGPH20 plus AG than with placebo plus AG included fatigue (16.0%  v  9.6%), muscle spasms (6.5%  v  0.6%), and hyponatremia (8.0%  v  3.8%).
","['HALO 109-301 was a phase III', 'Patients', 'Patients ≥ 18 years of age with untreated, metastatic, hyaluronan-high PDA', 'patients with hyaluronan-high metastatic pancreatic ductal adenocarcinoma (PDA', '494 patients were randomly assigned, with 492 (327 for PEGPH20 and 165 for']","['pegvorhyaluronidase alfa (PEGPH20) plus nab-paclitaxel/gemcitabine (AG', 'Pegvorhyaluronidase Alfa', 'PEGPH20 plus AG or placebo plus AG', 'PEGPH20 plus AG', 'gemcitabine', 'Nab-Paclitaxel Plus Gemcitabine', 'placebo']","['overall survival (OS); secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety', 'fatigue', 'ORR', 'efficacy and safety', 'Grade ≥ 3 adverse events', 'hyponatremia', 'muscle spasms', 'median PFS']","[{'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2826358', 'cui_str': 'PEGPH20'}, {'cui': 'C4319555', 'cui_str': '165'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2826358', 'cui_str': 'PEGPH20'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",494.0,0.605717,"Grade ≥ 3 adverse events with a ≥ 2% higher rate with PEGPH20 plus AG than with placebo plus AG included fatigue (16.0%  v  9.6%), muscle spasms (6.5%  v  0.6%), and hyponatremia (8.0%  v  3.8%).
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Tempero', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, UCSF Medical Center, San Francisco, CA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Sigal', 'Affiliation': 'Division of Hematology/Oncology, Scripps Clinic and Scripps MD Anderson Cancer Center, La Jolla, CA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fazio', 'Affiliation': 'Division of Gastrointestinal Medical Oncology & Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hitre', 'Affiliation': 'Department of Medical Oncology and Clinical Pharmacology ""B,"" National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Hôpital Beaujon (AP-HP), Clichy, and Université de Paris, Paris, France.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Hendifar', 'Affiliation': 'Department of Gastrointestinal Malignancies, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Bates', 'Affiliation': 'Division of Hematology/Oncology, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Chung-Pin', 'Initials': 'CP', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sunil R', 'Initials': 'SR', 'LastName': 'Hingorani', 'Affiliation': 'Fred Hutchinson Cancer Research Center and Division of Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardiere', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Kasi', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Maraveyas', 'Affiliation': 'Joint Centre for Cancer Studies, Hull York Medical School, Castle Hill Hospital, Cottingham, United Kingdom.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Bahary', 'Affiliation': 'Department of Internal Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Layos', 'Affiliation': 'Medical Oncology Service, Catalan Institute of Oncology (ICO), Hospital Germans Trias i Pujol, Badalona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Sahai', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'The Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Lacy', 'Affiliation': 'Department of Medicine, Section of Medical Oncology, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Joon Oh', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Institut du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oberstein', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, NY.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, CA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Chondros', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, CA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Bullock', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00590']
1595,32707101,The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).,"BACKGROUND


Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
METHODS


We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
PROJECTED OUTCOMES


This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.",2020,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","['partnership with a primary care clinic in a low-income, majority Latino community', 'Families with 2- to 5-year-old children', 'integrated primary care (the healthy communities 4 healthy students study']",['Family Check-Up 4 Health (FCU4Health) program'],"['RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance', 'cost, acceptability, appropriateness, and feasibility', 'child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",,0.0514529,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","[{'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': ""REACH Institute, Arizona State University, Tempe, AZ, USA; Phoenix Children's Hospital, Phoenix, AZ, USA. Electronic address: Cady.Berkel@asu.edu.""}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology (Ce-PIM), Department of Psychiatry and Behavioral Sciences, Department of Preventive Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Meg M', 'Initials': 'MM', 'LastName': 'Bruening', 'Affiliation': 'Department of Nutrition, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mauricio', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Winslow', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ray', 'Affiliation': 'Bayless Integrated Healthcare, Phoenix, AZ, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bourne', 'Affiliation': 'Southwest Maricopa Regional Council, First Things First, Peoria, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106088']
1596,32712806,"Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.","INTRODUCTION


Patients with relapsed or refractory multiple myeloma (RRMM) represent an unmet clinical need. Belantamab mafodotin (belamaf; GSK2857916) is a first-in-class antibody-drug conjugate (ADC; or immunoconjugate) that delivers a cytotoxic payload, monomethyl auristatin F (MMAF), to myeloma cells. In the phase II DREAMM-2 study (NCT03525678), single-agent belamaf (2.5 mg/kg) demonstrated clinically meaningful anti-myeloma activity (overall response rate 32%) in patients with heavily pretreated disease. Microcyst-like epithelial changes (MECs) were common, consistent with reports from other MMAF-containing ADCs.
METHODS


Corneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected. A literature review on corneal events reported with other ADCs was performed.
RESULTS


In most patients receiving single-agent belamaf (72%; 68/95), MECs were observed by slit lamp microscopy early in treatment (69% had their first event by dose 4). However, IVCM revealed hyperreflective material. Blurred vision (25%) and dry eye (15%) were commonly reported symptoms. Management of MECs included dose delays (47%)/reductions (25%), with few patients discontinuing due to MECs (1%). The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date. A literature review confirmed that similar MECs were reported with other ADCs; however, event management strategies varied. The pathophysiology of MECs is unclear, though the ADC cytotoxic payload may contribute to on- or off-target effects on corneal epithelial cells.
CONCLUSION


Single-agent belamaf represents a new treatment option for patients with RRMM. As with other ADCs, MECs were observed and additional research is warranted to determine their pathophysiology. A multidisciplinary approach, involving close collaboration between eye care professionals and hematologist/oncologists, is needed to determine appropriate diagnosis and management of these patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier, NCT03525678.",2020,"The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date.","['patients with heavily pretreated disease', 'patients with RRMM', 'Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin', 'Corneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected', 'Patients with relapsed or refractory multiple myeloma (RRMM']",[],"['visual acuity', 'Blurred vision', 'clinically meaningful anti-myeloma activity', 'blurred vision', 'Microcyst-like epithelial changes (MECs', 'MECs', 'permanent vision loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}, {'cui': 'C0438105', 'cui_str': 'Examination finding'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",[],"[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",,0.0423515,"The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date.","[{'ForeName': 'Asim V', 'Initials': 'AV', 'LastName': 'Farooq', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA. afarooq@bsd.uchicago.edu.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Degli Esposti', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Praneetha', 'Initials': 'P', 'LastName': 'Thulasi', 'Affiliation': 'Emory Eye Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Zaugg', 'Affiliation': 'Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ashraf Z', 'Initials': 'AZ', 'LastName': 'Badros', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bennie H', 'Initials': 'BH', 'LastName': 'Jeng', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Opalinska', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'January', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Colby', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00280-8']
1597,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1598,32717773,"Effects of high-frequency, high-intensity transcutaneous electrical nerve stimulation versus intravenous opioids for pain relief after hysteroscopy: a randomized controlled study.","OBJECTIVE


To compare the time spent in the Post-Anesthesia Care Unit (PACU) and the pain-relieving effects of treatment with high-frequency, high-intensity transcutaneous electrical nerve stimulation (TENS) or intravenous (IV) opioids after hysteroscopy.
METHODS


All patients who postoperatively reported a visual analogue scale (VAS) pain score of ≥3 were included in the study. TENS treatment was given with a stimulus intensity between 40 and 60 mA for 1 minute and repeated once if there was insufficient pain relief. In the opioid group, a fractionated dose of 5 mg morphine was administered. If the patient reported insufficient pain relief after the assigned treatment, the patient was reassigned to the other treatment group.
RESULTS


Seventy-four women were randomized to TENS (n=38) or IV opioids (n=36) for treatment. Both groups reported significant pain relief after discharge from the PACU, with a decrease of VAS scores from 5.6 to 1.4 in the TENS group (P<0.001) and 5.1 to 1.3 in the opioid group (P<0.001). There were no significant differences between the groups. When only the responders in both groups, i.e., patients with VAS scores of <3 on respectively assigned treatments, were compared, the TENS responders (n=22) were found to have spent a significantly shorter time in the PACU (91 vs. 69 minutes, P=0.013) compared to the opioid responders (n=20).
CONCLUSION


Using TENS as first line of pain relief may reduce the need for postoperative opioids. In addition, TENS appears preferable as the first line of treatment due to its association with a shorter time spent in the PACU if the patient responds to the treatment.
TRIAL REGISTRATION


Västra Götalandsregionen Identifier: 211261.",2020,"Both groups reported significant pain relief after discharge from the PACU, with a decrease of VAS scores from 5.6 to 1.4 in the TENS group (P<0.001) and 5.1 to 1.3 in the opioid group (P<0.001).","['pain relief after hysteroscopy', 'Results\n\n\nSeventy-four women', 'All patients who postoperatively reported a visual analogue scale (VAS) pain score of ≥3 were included in the study']","['TENS', 'high-frequency, high-intensity transcutaneous electrical nerve stimulation (TENS) or intravenous (IV) opioids', 'high-frequency, high-intensity transcutaneous electrical nerve stimulation versus intravenous opioids', 'IV opioids', 'morphine']","['pain relief', 'VAS scores']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",74.0,0.0842403,"Both groups reported significant pain relief after discharge from the PACU, with a decrease of VAS scores from 5.6 to 1.4 in the TENS group (P<0.001) and 5.1 to 1.3 in the opioid group (P<0.001).","[{'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Platon', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital/Östra, Gothenburg, Sweden.'}, {'ForeName': 'Sven-Egron', 'Initials': 'SE', 'LastName': 'Thörn', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Clas', 'Initials': 'C', 'LastName': 'Mannheimer', 'Affiliation': 'Multidisciplinary Pain Center Kungälv Hospital Kungälv and Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Andréll', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Obstetrics & gynecology science,['10.5468/ogs.20063']
1599,32718927,Are prolonged sitting and sleep restriction a dual curse for the modern workforce? a randomised controlled trial protocol.,"INTRODUCTION


Prolonged sitting and inadequate sleep are a growing concern in society and are associated with impairments to cardiometabolic health and cognitive performance. However, the combined effect of prolonged sitting and inadequate sleep on measures of health and cognitive performance are unknown. In addition, the circadian disruption caused by shiftwork may further impact workers' cardiometabolic health and cognitive performance. This protocol paper outlines the methodology for exploring the impact of simultaneous exposure to prolonged sitting, sleep restriction and circadian disruption on cardiometabolic and cognitive performance outcomes.
METHODS AND ANALYSIS


This between-subjects study will recruit 208 males and females to complete a 7-day in-laboratory experimental protocol (1 Adaptation Day, 5 Experimental Days and 1 Recovery Day). Participants will be allocated to one of eight conditions that include all possible combinations of the following: dayshift or nightshift, sitting or breaking up sitting and 5 hour or 9 hour sleep opportunity. On arrival to the laboratory, participants will be provided with a 9 hour baseline sleep opportunity (22:00 to 07:00) and complete five simulated work shifts (09:00 to 17:30 in the dayshift condition and 22:00 to 06:30 in the nightshift condition) followed by a 9 hour recovery sleep opportunity (22:00 to 07:00). During the work shifts participants in the sitting condition will remain seated, while participants in the breaking up sitting condition will complete 3-min bouts of light-intensity walking every 30 mins on a motorised treadmill. Sleep opportunities will be 9 hour or 5 hour. Primary outcome measures include continuously measured interstitial blood glucose, heart rate and blood pressure, and a cognitive performance and self-perceived capacity testing battery completed five times per shift. Analyses will be conducted using linear mixed models.
ETHICS AND DISSEMINATION


The CQUniversity Human Ethics Committee has approved this study (0000021914). All participants who have already completed the protocol have provided informed consent. Study findings will be disseminated via scientific publications and conference presentations.
TRIAL REGISTRATION DETAILS


This study has been registered on Australian New Zealand Clinical Trials Registry (12619001516178) and is currently in the pre-results stage.",2020,"Participants will be allocated to one of eight conditions that include all possible combinations of the following: dayshift or nightshift, sitting or breaking up sitting and 5 hour or 9 hour sleep opportunity.","['208 males and females to complete a 7-day in-laboratory experimental protocol (1 Adaptation Day, 5 Experimental Days and 1 Recovery Day', 'All participants who have already completed the protocol have provided informed consent']","['dayshift or nightshift, sitting or breaking up sitting and 5\u2009hour or 9\u2009hour sleep opportunity']","['continuously measured interstitial blood glucose, heart rate and blood pressure, and a cognitive performance and self-perceived capacity testing battery completed five times per shift']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",208.0,0.0567258,"Participants will be allocated to one of eight conditions that include all possible combinations of the following: dayshift or nightshift, sitting or breaking up sitting and 5 hour or 9 hour sleep opportunity.","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Vincent', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia g.vincent@cqu.edu.au.'}, {'ForeName': 'Charlotte C', 'Initials': 'CC', 'LastName': 'Gupta', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Sprajcer', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': 'School of Health Medical and Applied Sciences, Central Queensland University, Rockhampton, Queensland, Australia.'}, {'ForeName': 'Mitch J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'School of Medicine & Public Health, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Tucker', 'Affiliation': 'Psychology Department, Swansea University, Swansea, United Kingdom.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Lastella', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Tuckwell', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Ferguson', 'Affiliation': 'Appleton Institute, Central Queensland University - Adelaide Campus, Wayville, South Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040613']
1600,32729120,"The effect of cannabidiol on simulated car driving performance: A randomised, double-blind, placebo-controlled, crossover, dose-ranging clinical trial protocol.","OBJECTIVE


Interest in the use of cannabidiol (CBD) is increasing worldwide as its therapeutic effects are established and legal restrictions moderated. Unlike Δ 9  -tetrahydrocannabinol (Δ 9  -THC), CBD does not appear to cause cognitive or psychomotor impairment. However, further assessment of its effects on cognitively demanding day-to-day activities, such as driving, is warranted. Here, we describe a study investigating the effects of CBD on simulated driving and cognitive performance.
METHODS


Thirty healthy individuals will be recruited to participate in this randomised, double-blind, placebo-controlled crossover trial. Participants will complete four research sessions each involving two 30-min simulated driving performance tests completed 45 and 210 min following oral ingestion of placebo or 15, 300, or 1,500 mg CBD. Cognitive function and subjective drug effects will be measured, and blood and oral fluid sampled, at regular intervals. Oral fluid drug testing will be performed using the Securetec DrugWipe® 5S and Dräger DrugTest® 5000 devices to determine whether CBD increases the risk of ""false-positive"" roadside tests to Δ 9  -THC. Noninferiority analyses will test the hypothesis that CBD is no more impairing than placebo.
CONCLUSION


This study will clarify the risks involved in driving following CBD use and assist in ensuring the safe use of CBD by drivers.",2020,"Participants will complete four research sessions each involving two 30-min simulated driving performance tests completed 45 and 210 min following oral ingestion of placebo or 15, 300, or 1,500 mg CBD.",['Thirty healthy individuals'],"['cannabidiol (CBD', 'cannabidiol', 'CBD', 'placebo']","['simulated car driving performance', 'Cognitive function and subjective drug effects']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}]",30.0,0.520948,"Participants will complete four research sessions each involving two 30-min simulated driving performance tests completed 45 and 210 min following oral ingestion of placebo or 15, 300, or 1,500 mg CBD.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Benson', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anastasia S', 'Initials': 'AS', 'LastName': 'Suraev', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Irwin', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Arkell', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Brain and Mind Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}]",Human psychopharmacology,['10.1002/hup.2749']
1601,32729819,Bioequivalence study of two formulations of memantine hydrochloride tablets in healthy male Chinese subjects under fasting and fed conditions.,"PURPOSE


Memantine is currently the only drug that acts on the glutamate energy system to treat Alzheimer's disease. A generic memantine tablet was developed to offer an alternative to the marketed tablet formulation. The purpose of this study was to assess the bioequivalence of two different memantine formulations among healthy male Chinese subjects under fasting and fed conditions.
MATERIALS AND METHODS


We carried out single-center, randomized, single-dose, open-label, two-period, cross-over studies which including 20 healthy male Chinese subjects under fasting and fed conditions, respectively. Plasma samples were collected prior to and up to 240 hours after dosing. Key pharmacokinetic parameters including area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t ), area from time zero to infinite (AUC 0-∞ ), and C max  were used for bioequivalence assessment.
RESULTS


Under fasting condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 106.5 - 114.0% for C max , 99.4 - 107.9% for AUC 0-t , and 100.0 - 109.6% for AUC 0-∞ . Under fed condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 94.8 - 104.3% for C max , 98.2 - 110.5% for AUC 0-t , and 99.2 - 113.0% for AUC 0-∞ .
CONCLUSION


The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).",2020,The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state.,"['20 healthy male Chinese subjects under fasting and fed conditions, respectively', 'healthy male Chinese subjects under fasting and fed conditions', 'healthy male Chinese subjects under fasting and fed conditions\u2029']","['memantine hydrochloride tablets', 'memantine', 'memantine formulations', 'Memantine']","['plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t ), area from time zero to infinite (AUC 0-∞ ), and C max', 'geometric mean ratios of the test/reference drug for memantine']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0771988', 'cui_str': 'Memantine hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]",20.0,0.0343325,The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state.,"[{'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Jiangying', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Mai', 'Affiliation': ''}, {'ForeName': 'Xiyong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Zhong', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203683']
1602,32553875,Precision of Dynamic Navigation to Perform Endodontic Ultraconservative Access Cavities: A Preliminary In Vitro Analysis.,"INTRODUCTION


Ultraconservative access cavities (UCACs) have been proposed to reduce crown weakening, but there is no consensus about their design and size and about their advantages and disadvantages, which are also related to how differently they are performed. The purpose of the present study was to evaluate the possible use of a novel Dynamic Navigation System (DNS) in planning and executing UCACs and its precision in vitro, compared with a manual approach (MA) without any guide.
METHODS


Twenty radiopaque, artificial teeth replicas were randomly divided into 2 identical groups and scanned using cone-beam computed tomography. In the first group (MA) MB1 canal orifice was reached, starting from the central part of the molar occlusal surface, using a micro endodontic bur. In the second group, DNS allowed to plan and execute a more direct, straight-line truss access. After cavity preparation, teeth were scanned again, and cone-beam computed tomography images were compared. Data were statistically analyzed with analysis of variance test.
RESULTS


Significant differences (P < .05) were found in the tested parameters between the 2 groups. The DNS group was significantly more precise, showing smaller mean values in the angulation (4.8°) and in the maximum distance from the ideal position (0.34 mm), when compared with MA group (mean values, 21.2° and 0.88 mm, respectively).
CONCLUSIONS


Hence, we may conclude that the use of DNS increased the benefits of UCACs by minimizing the potential risk of iatrogenic weakening of critical portions of the crown and reducing negative influences to shaping procedures.",2020,"The DNS group was significantly more precise, showing smaller mean values in the angulation (4.8°) and in the maximum distance from the ideal position (0.34 mm), when compared with MA group (mean values, 21.2° and 0.88 mm, respectively).
","['Twenty radiopaque, artificial teeth replicas']","['Dynamic Navigation to Perform Endodontic Ultraconservative Access Cavities', 'scanned using cone-beam computed tomography', 'novel Dynamic Navigation System (DNS']",[],"[{'cui': 'C0040454', 'cui_str': 'Artificial Teeth'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}]",[],20.0,0.0265075,"The DNS group was significantly more precise, showing smaller mean values in the angulation (4.8°) and in the maximum distance from the ideal position (0.34 mm), when compared with MA group (mean values, 21.2° and 0.88 mm, respectively).
","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gambarini', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, University of Rome, Sapienza, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, University of Rome, Sapienza, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Morese', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, University of Rome, Sapienza, Italy.'}, {'ForeName': 'Luigi Vito', 'Initials': 'LV', 'LastName': 'Stefanelli', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, University of Rome, Sapienza, Italy.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Abduljabbar', 'Affiliation': 'Dental Department, King Abdulaziz Medical City, Jeddaah, Saudi Arabia.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Giovarruscio', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Di Nardo', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, University of Rome, Sapienza, Italy. Electronic address: dario.dinardo@uniroma1.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Seracchiani', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, University of Rome, Sapienza, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Testarelli', 'Affiliation': 'Department of Oral and Maxillo-Facial Sciences, University of Rome, Sapienza, Italy.'}]",Journal of endodontics,['10.1016/j.joen.2020.05.022']
1603,32696033,"Subcutaneous administration of benzathine benzylpenicillin G has favourable pharmacokinetic characteristics for the prevention of rheumatic heart disease compared with intramuscular injection: a randomized, crossover, population pharmacokinetic study in healthy adult volunteers.","BACKGROUND


Benzathine penicillin G has been used as monthly deep intramuscular (IM) injections since the 1950s for secondary prevention of acute rheumatic fever and rheumatic heart disease (RHD). Injection frequency and pain are major programmatic barriers for adherence, prompting calls for development of better long-acting penicillin preparations to prevent RHD. We hypothesized that subcutaneous (SC) administration of benzathine penicillin G could delay penicillin absorption when compared with IM injections.
METHODS


To compare the pharmacokinetic profile and tolerability of benzathine penicillin G according to different routes of administration, 15 healthy males participated in a randomized crossover study to receive benzathine penicillin G by either SC or IM routes, with a 10 week washout period before the second dose by the alternative route. Ultrasound guidance confirmed injection location. Penicillin concentrations and pain scores were measured for 6 weeks following injections.
RESULTS


SC administration was well tolerated with no significant differences in pain scores. Following SC injection, the principal absorption half-life (95% CI) was 20.1 (16.3-29.5) days and 89.6% (87.1%-92.0%) of the drug was directed via this pathway compared with 10.2 (8.6-12.5) days and 71.3% (64.9%-77.4%) following IM administration. Lower peak and higher trough penicillin concentrations resulted following SC injection. Simulations demonstrated that SC infusion of higher doses of benzathine penicillin G could provide therapeutic penicillin concentrations for 3 months.
CONCLUSIONS


SC administration of benzathine penicillin G is safe and significantly delays penicillin absorption. High-dose benzathine penicillin G via the SC route would fulfil many product characteristics required for the next generation of longer-acting penicillins for use in RHD.",2020,"RESULTS


SC administration was well tolerated with no significant differences in pain scores.","['15 healthy males', 'healthy adult volunteers']","['benzathine benzylpenicillin G', 'Benzathine penicillin G', 'benzathine penicillin G']","['pain scores', 'Lower peak and higher trough penicillin concentrations', 'pharmacokinetic profile and tolerability', 'delay penicillin absorption', 'Penicillin concentrations and pain scores', 'therapeutic penicillin concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0030829', 'cui_str': 'benzathine benzylpenicillin'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",15.0,0.295838,"RESULTS


SC administration was well tolerated with no significant differences in pain scores.","[{'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Kado', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Salman', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Department of Radiology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hand', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Wyber', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Page-Sharp', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Batty', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa282']
1604,32693615,A Prospective Randomized Trial of N-butyl-cyanoacrylate + Metacryloxysulfolane Adhesive versus Suture Alone for Grafting in Rhinoplasty: 9 year Follow-up.,"OBJECTIVE


Use of cyanoacrylate glue in facial plastic surgery is still controversial due to the absence of long-term follow up showing the results. Aim of our study is comparing the long-term outcomes of N-butyl-cyanoacrylate + Metacryloxysulfolane versus traditional sutures in rhinoplasty.
METHODS


Prospective comparative study. One hundred forty-two patients affected by ptotic nasal tip were included and randomized in two groups. In group A, the surgeon fixed the graft by using the glue and suture and in group B by using the traditional suture only. The following data were collected and compared by statistical analysis: nasolabial angle before and after surgery, dimensions of the graft, duration time (in minutes) for graft application during the surgery, number of sutures applied to fix the graft, presence of post-surgery negative outcomes.
RESULTS


All patients statistically improved their nasolabial angle after surgery (ANOVA:  P  < .0001) without statistically significant differences between the two groups both at short and long follow-up (χ: P  = 1 and  P  = .9 respectively). A statistically significant difference in graft fixation time ( P  < .00001) and number of sutures (t:  P  < .00001) used was observed between the two groups. No statistically significant difference was observed in prevalence of infection after surgery.
CONCLUSION


N-butyl-cyanoacrylate + Metacryloxysulfolane could be a valid tool to reduce the necessary number of sutures and to reduce the time required for graft fixation graft fixation with consistent results in long-term follow-up.",2020,A statistically significant difference in graft fixation time ( P  < .00001) and number of sutures (t:  P  < .00001) used was observed between the two groups.,"['One hundred forty-two patients affected by ptotic nasal tip', 'facial plastic surgery']","['N-butyl-cyanoacrylate + Metacryloxysulfolane', 'cyanoacrylate glue', 'N-butyl-cyanoacrylate + Metacryloxysulfolane Adhesive versus Suture Alone']","['nasolabial angle', 'number of sutures', 'prevalence of infection', 'time required for graft fixation graft fixation', 'graft fixation time']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0225409', 'cui_str': 'Structure of apex of nose'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}]","[{'cui': 'C0014035', 'cui_str': 'Enbucrilate'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0429143', 'cui_str': 'Nasolabial angle'}, {'cui': 'C0457280', 'cui_str': 'Number of sutures'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",142.0,0.0413664,A statistically significant difference in graft fixation time ( P  < .00001) and number of sutures (t:  P  < .00001) used was observed between the two groups.,"[{'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Martino', 'Affiliation': 'University Hospital of Salerno, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Salzano', 'Affiliation': 'University Hospital of Salerno, Italy.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Martino', 'Affiliation': 'The nose clinic, rhinosurgery unit c/o check-up day-surgery Salerno, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Organ of Sense Department, La Sapienza University of Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'De Vincentiis', 'Affiliation': 'Organ of Sense Department, La Sapienza University of Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Maranzano', 'Affiliation': 'Department of Oral Maxillo-Facial and Facial Plastic Surgery, University of Manchester, Manchester, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': 'Organ of Sense Department, La Sapienza University of Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Salzano', 'Affiliation': 'Head and Neck Department, Neurosciences, Reproductive and Odontostomatological Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Di Stadio', 'Affiliation': 'Otolaryngology Department, University of Perugia, Perugia, Italy.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420943910']
1605,32699034,"Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial.","OBJECTIVES


This ongoing Phase-2, randomised, placebo-controlled, double-blind study evaluated the efficacy, safety and pharmacokinetics of intravenous belimumab in childhood-onset systemic lupus erythematosus (cSLE).
METHODS


Patients (5 to 17 years) were randomised to belimumab 10 mg/kg intravenous or placebo every 4 weeks, plus standard SLE therapy. Primary endpoint: SLE Responder Index (SRI4) response rate (Week 52). Key major secondary endpoints: proportion of patients achieving the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) response using 50 and '30 alternative' definitions (Week 52), and sustained response (Weeks 44 to 52) by SRI4 and Parent Global Assessment of well-being (Parent-global). Safety and pharmacokinetics were assessed. Study not powered for statistical testing.
RESULTS


Ninety-three patients were randomised (belimumab, n=53; placebo, n=40). At Week 52, there were numerically more SRI4 responders with belimumab versus placebo (52.8% vs 43.6%; OR 1.49 (95% CI 0.64 to 3.46)). PRINTO/ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were sustained responses for SRI4 (belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI 0.46 to 2.52)) and Parent-global (belimumab, 59.1%; placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)). Serious adverse events were reported in 17.0% of belimumab patients and 35.0% of placebo patients; one death occurred (placebo). Week-52, geometric mean (95% CI) belimumab trough concentration was 56.2 (45.2 to 69.8) µg/mL.
CONCLUSION


The belimumab intravenous pharmacokinetics and benefit-risk profile in cSLE are consistent with adult belimumab studies and the 10 mg/kg every 4 weeks dose is appropriate.
TRIAL REGISTRATION NUMBER


NCT01649765.",2020,"ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were sustained responses for SRI4 (belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI 0.46 to 2.52)) and Parent-global (belimumab, 59.1%; placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)).","['childhood-onset systemic lupus erythematosus (cSLE', 'Ninety-three patients were randomised (belimumab, n=53', 'Patients (5 to 17 years', 'children with systemic lupus erythematosus']","['placebo', 'belimumab 10 mg/kg intravenous or placebo every 4 weeks, plus standard SLE therapy', 'intravenous belimumab']","['efficacy, safety and pharmacokinetics', 'death', 'Safety and pharmacokinetics', 'Safety and efficacy', 'SRI4 responders', ""patients achieving the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) response using 50 and '30 alternative' definitions (Week 52), and sustained response (Weeks 44 to 52) by SRI4 and Parent Global Assessment of well-being (Parent-global"", 'SLE Responder Index (SRI4) response rate (Week 52', 'Serious adverse events']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",93.0,0.776003,"ACR 30 alternative (52.8% vs 27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to 6.54)) responses were more frequent with belimumab than placebo, as were sustained responses for SRI4 (belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI 0.46 to 2.52)) and Parent-global (belimumab, 59.1%; placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)).","[{'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA Hermine.brunner@cchmc.org.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Abud-Mendoza', 'Affiliation': 'Hospital Central ""Dr Ignacio Morones Prieto"", Unidad Regional de Reumatologia y Osteoporosis, Hospital Central and Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico.'}, {'ForeName': 'Diego O', 'Initials': 'DO', 'LastName': 'Viola', 'Affiliation': 'Reumatologia, Instituto CAICI, Rosario, Argentina.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Calvo Penades', 'Affiliation': 'Pediatric Rheumatology Unit, Hospital Universitario y Politecnico la Fe, Valencia, Spain.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': 'Rheumatology, Hospital for Sick Children and Univeristy of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Anton', 'Affiliation': 'Division of Pediatric Rheumatology, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Calderon', 'Affiliation': 'El Derby, Instituto de Ginecologia y Reproduccion, Lima, Peru.'}, {'ForeName': 'Vyacheslav G', 'Initials': 'VG', 'LastName': 'Chasnyk', 'Affiliation': 'Department of Hospital Pediatrics, Saint Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Ferrandiz', 'Affiliation': 'Reumatologia, Instituto Nacional de Salud del Niño, Lima, Peru.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Keltsev', 'Affiliation': 'Pediatric Department, Togliatti City Clinical Hospital №5, Togliatti, Russian Federation.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Paz Gastanaga', 'Affiliation': 'Servicio de Reumatologia, Clinica Anglo Americana, Lima, Peru.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shishov', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, Arizona, USA.""}, {'ForeName': 'Alina Lucica', 'Initials': 'AL', 'LastName': 'Boteanu', 'Affiliation': 'Pediatric Rheumatology Unit, University Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Henrickson', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Bass', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'GSK, Stevenage, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hammer', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Beulah N', 'Initials': 'BN', 'LastName': 'Ji', 'Affiliation': 'GSK, Stevenage, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nino', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Roth', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Struemper', 'Affiliation': 'GSK, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Mei-Lun', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'GSK, Collegevile, Pennsylvania, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Università degli Studi di Genova, Genova, Liguria, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lovell', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Clinica Pediatrica e Reumatologia, PRINTO, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217101']
1606,32700492,[Back arm flexion and extension combined with manipulation for the treatment of patient with adhesive scapulohumeral periarthritis].,"OBJECTIVE


To observe clinical efficacy of back arm flexion and extension combined with manipulation in treating adhesive scapulohumeral periarthritis.
METHODS


From March 2016 to April 2018, 53 patients with adhesive scapulohumeral periarthritis were treated with back arm flexion and extension combined with manipulation, the main symptoms were shoulder pain and limited activity. There were 22 males and 31 females aged from 45 to 71 years old with an average of (51.63±5.79) years;the courses of disease ranged from 3 to 24 months with an average of (8.62±3.73) months. Manipulation treatment was carried out once a week, and back arm flexion and extension were performed for 3 times a day with15 movements each time, totally 4 weeks for a single course. Visual analogue scale (VAS) and Constant-Murley shoulder function score were observed and compared before treatment and one week, one and three months after treatment.
RESULTS


All patients were followed up from 3 to 12 months, with an average of (5.91±3.55) months. VAS score before treatment was 4.02±1.46, and was improved to 3.15±1.54, 1.98±1.37, 1.12±0.86 respectively at one week, one and three months after treatment. Constant-Murley score before treatment was 42.70 ±5.72, and improved to 54.25 ±6.34, 67.45 ±6.84, 82.40 ±6.63 at one week, one and three months after treatment respectively;19 patients got excellent result, 22 good, 9 fair and 3 poor.
CONCLUSION


Back arm flexion combined with manipulation for the treatment of adhesive scapulohumeral periarthritis could effectively relieve pain, improve shoulder function, which is a simple effective treatment strategy.",2020,"CONCLUSION


Back arm flexion combined with manipulation for the treatment of adhesive scapulohumeral periarthritis could effectively relieve pain, improve shoulder function, which is a simple effective treatment strategy.","['22 males and 31 females aged from 45 to 71 years old with an average of (51.63±5.79) years;the courses of disease ranged from 3 to 24 months with an average of (8.62±3.73) months', 'patient with adhesive scapulohumeral periarthritis', 'From March 2016 to April 2018, 53 patients with adhesive scapulohumeral periarthritis']","['back arm flexion and extension combined with manipulation', 'Back arm flexion and extension combined with manipulation']","['Constant-Murley score', 'Visual analogue scale (VAS) and Constant-Murley shoulder function score', 'VAS score']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0031037', 'cui_str': 'Periarthritis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",53.0,0.0277231,"CONCLUSION


Back arm flexion combined with manipulation for the treatment of adhesive scapulohumeral periarthritis could effectively relieve pain, improve shoulder function, which is a simple effective treatment strategy.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Hong-Sheng', 'Initials': 'HS', 'LastName': 'Zhan', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Qing-Lai', 'Initials': 'QL', 'LastName': 'Wang', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Hui-Ming', 'Initials': 'HM', 'LastName': 'Wu', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}, {'ForeName': 'Jiang-Tao', 'Initials': 'JT', 'LastName': 'Zhou', 'Affiliation': 'Wenzhou TCM Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine, Wenzhou 325000, Zhejiang, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.07.014']
1607,32702468,Predicting post one-year durability of glucose-lowering monotherapies in patients with newly-diagnosed type 2 diabetes mellitus - A MASTERMIND precision medicine approach (UKPDS 87).,"AIMS


Predicting likely durability of glucose-lowering therapies for people with type 2 diabetes (T2D) could help inform individualised therapeutic choices.
METHODS


We used data from UKPDS patients with newly-diagnosed T2D randomised to first-line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin. In 2339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥ 7.5% or requiring second-line therapy). Model validation was performed using bootstrap sampling.
RESULTS


Follow-up was median (IQR) 11.0 (8.0-14.0) years. Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years. Time-to-monotherapy-failure was predicted primarily by HbA 1c  and BMI values-with other risk factors varying by type of monotherapy-with predictions to within ±2.5 years for 55%-60%-56% and 57% of the chlorpropamide-glibenclamide-basal insulin and metformin monotherapy cohorts respectively.
CONCLUSIONS


Post one-year glycaemic durability can be predicted robustly in individuals with newly-diagnosed T2D who achieve HbA 1c values  < 7.5% one year after commencing traditional monotherapies. Such information could be used to help guide glycaemic management for individual patients.",2020,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"['2,339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥7.5% or requiring second-line therapy', 'people with type 2 diabetes ', 'Patients with Newly-diagnosed Type 2 Diabetes Mellitus', 'UKPDS patients with newly-diagnosed T2D randomised to first']","['chlorpropamide-glibenclamide-basal insulin or metformin', 'line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin', 'glucose-lowering therapies', 'Glucose-lowering Monotherapies']","['Monotherapy-failure', 'Time-to-monotherapy-failure']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0008287', 'cui_str': 'Chlorpropamide'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2339.0,0.0533422,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"[{'ForeName': 'Olorunsola F', 'Initials': 'OF', 'LastName': 'Agbaje', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK. Electronic address: olorunsola.agbaje@dtu.ox.ac.uk.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Jones', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Medical Research Institute, University of Dundee, Dundee, UK.'}, {'ForeName': 'Beverley M', 'Initials': 'BM', 'LastName': 'Shields', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108333']
1608,32705829,[Effect of Tongdu Tiaoshen needling in treatment of chronic insomnia by regulating the hypothalamic-pituitary-adrenal axis].,"OBJECTIVE


To investigate the clinical effect of Tongdu Tiaoshen needling in the treatment of chronic insomnia and its mechanism based on the hypothalamic-pituitary-adrenal (HPA) axis.
METHODS


A total of 60 patients with chronic insomnia were randomly divided into treatment group and control group, with 30 patients in each group. In addition to the health education on sleep, the patients in the treatment group were given Tongdu Tiaoshen needling, i．e., electroacupuncture at Baihui (GV20), Shenting (GV24), Yintang (EX-HN3), bilateral Shenmen (HT7), and bilateral Sanyinjiao (SP6), and those in the control group were given superficial acupuncture at Shousanli (LI10), Futu (ST32), and Feiyang (BL58) at both sides, once every other day and three times a week for 4 consecutive weeks. Before and after treatment, the Pittsburgh Sleep Quality Index (PSQI) was used to assess the quality and efficiency of sleep, and ELISA was used to measure the serum levels of corticotropin-releasing hormone (CRH), adrenocorticotropic hormone (ACTH), and corticosterone (CORT).
RESULTS


After treatment, the treatment group had significant reductions in the total PSQI score and the score of each component of PSQI ( P <0.01), and the control group had significant reductions in the total PSQI score ( P <0.01) and the scores of all components except sleep duration ( P <0.05); compared with the control group, the treatment group had significantly lower total PSQI score and the score of each component ( P <0.01). After treatment, the treatment group had significant reductions in the serum levels of CRH, ACTH and CORT ( P <0.05，P <0.01), and compared with the control group, the treatment group had significant reductions in the serum levels of CRH, ACTH and CORT ( P <0.01， P <0.05).
CONCLUSION


Tongdu Tiaoshen needling has a good clinical effect in the treatment of chronic insomnia and can significantly improve the sleep condition of patients with chronic insomnia, possibly by reducing the hormones associated with the HPA axis.",2020,"After treatment, the treatment group had significant reductions in the serum levels of CRH, ACTH and CORT ( P <0.05，P","['patients with chronic insomnia', '60 patients with chronic insomnia']","['Tongdu Tiaoshen needling, i．e., electroacupuncture at Baihui (GV20), Shenting (GV24), Yintang (EX-HN3), bilateral Shenmen (HT7), and bilateral Sanyinjiao (SP6), and those in the control group were given superficial acupuncture at Shousanli (LI10), Futu (ST32), and Feiyang (BL58', 'Tongdu Tiaoshen needling']","['sleep duration', 'chronic insomnia', 'Pittsburgh Sleep Quality Index (PSQI', 'serum levels of corticotropin-releasing hormone (CRH), adrenocorticotropic hormone (ACTH), and corticosterone (CORT', 'quality and efficiency of sleep, and ELISA', 'serum levels of CRH, ACTH and CORT', 'total PSQI score and the score of each component of PSQI', 'total PSQI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0450834', 'cui_str': 'Yintang'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0450652', 'cui_str': 'BL58'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0010124', 'cui_str': 'Corticosterone'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",60.0,0.0165864,"After treatment, the treatment group had significant reductions in the serum levels of CRH, ACTH and CORT ( P <0.05，P","[{'ForeName': 'Han-Qing', 'Initials': 'HQ', 'LastName': 'Xi', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Wen-Zhong', 'Initials': 'WZ', 'LastName': 'Wu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Cheng-Yong', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Xiao-Qiu', 'Initials': 'XQ', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Shi-Yu', 'Initials': 'SY', 'LastName': 'Zheng', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}, {'ForeName': 'Jia-Huan', 'Initials': 'JH', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Rehabilitation, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190791']
1609,32705831,[Effect of hysteretic acupuncture on joint function and related cytokines in articular fluid in patients with knee osteoarthritis].,"OBJECTIVE


To observe the difference of therapeutic effect between hysteretic acupuncture and Celecoxib capsules for knee osteoarthritis(KOA), and to investigate their effects on levels of interleukin 6(IL-6) and tumor necrosis factor α(TNF-α) in articular fluid.
METHODS


Seventy-two patients with KOA were randomly divided into hysteretic acupuncture and me-dication groups, with 36 cases in each group. The patients of the hysteretic acupuncture group received hysteretic acupuncture stimulation at Dubi (ST35), Neixiyan (EX-LE4), Zusanli (ST36), Yanglingquan (GB34), Yinlingquan (SP9), Xuehai (SP10), Liangqiu (ST34) and Heding (EX-LE2) as the main acupoints for 30 min once daily. The patients of the medication group received oral administration of Celecoxib capsules(200 mg) once daily. Both of the two groups were treated with 14 days as a course of treatment, with a 2-day rest between each course of treatment, and the treatments were conducted for 2 courses. The visual analogue scale(VAS) score of pain, Lequesne index score, IL-6 and TNF-α level in joint fluid and the change of traditional Chinese medicine(TCM) syndrome score were observed before and after treatment.
RESULTS


Compared with pre-treatment, the VAS score, Lequesne index score, IL-6 and TNF-α level, and total TCM syndrome score decreased significantly after treatment in both of the two groups ( P <0.05). Hysteretic acupuncture was more effective in reducing VAS score, Lequesne index score, IL-6 and TNF-α level than Celecoxib capsules ( P <0.05), and there was no significant difference in total TCM syndrome score and total effective rate between the two groups( P >0.05). No adverse events occurred in both groups during the treatment.
CONCLUSION


Hysteretic acupuncture can effectively relieve pain symptoms and improve joint function in KOA patients. Its effect is comparable to that of oral administration of Celecoxib capsules.",2020,"Compared with pre-treatment, the VAS score, Lequesne index score, IL-6 and TNF-α level, and total TCM syndrome score decreased significantly after treatment in both of the two groups ( P <0.05).","['Seventy-two patients with KOA', 'patients with knee osteoarthritis', 'knee osteoarthritis(KOA', 'KOA patients']","['Celecoxib capsules(200 mg) once daily', 'hysteretic acupuncture stimulation at Dubi (ST35), Neixiyan (EX-LE4), Zusanli (ST36), Yanglingquan (GB34), Yinlingquan (SP9), Xuehai (SP10), Liangqiu (ST34) and Heding (EX-LE2', 'hysteretic acupuncture and Celecoxib', 'hysteretic acupuncture', 'Hysteretic acupuncture', 'Celecoxib', 'hysteretic acupuncture and me-dication']","['VAS score, Lequesne index score, IL-6 and TNF-α level', 'joint function and related cytokines', 'joint function', 'total TCM syndrome score and total effective rate', 'VAS score, Lequesne index score, IL-6 and TNF-α level, and total TCM syndrome score', 'pain symptoms', 'adverse events', 'visual analogue scale(VAS) score of pain, Lequesne index score, IL-6 and TNF-α level in joint fluid and the change of traditional Chinese medicine(TCM) syndrome score']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444497', 'cui_str': 'In joint'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",72.0,0.0576997,"Compared with pre-treatment, the VAS score, Lequesne index score, IL-6 and TNF-α level, and total TCM syndrome score decreased significantly after treatment in both of the two groups ( P <0.05).","[{'ForeName': 'Guo-Xiang', 'Initials': 'GX', 'LastName': 'Wang', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Deng', 'Affiliation': 'Graduate School of Guangxi University of Chinese Medicine, Nanning 530001.'}, {'ForeName': 'Zi-Long', 'Initials': 'ZL', 'LastName': 'Liao', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China.'}, {'ForeName': 'Ri-Lan', 'Initials': 'RL', 'LastName': 'Chen', 'Affiliation': 'Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.200054']
1610,32705832,[Comparision of therapertic effect of different acupuncture methods for knee osteoarthritis].,"OBJECTIVE


To compare the clinical efficacy of acupuncture, electroacupuncture (EA) and moxibustion in the treatment of knee osteoarthritis (KOA).
METHODS


A total of eight-four patients with KOA were randomly and equally divided into acupuncture group, EA group and moxibustion group. Neixiyan (EX-LE40), Dubi (ST35), Heding (EX-LE2), Liangqiu (ST34), Xuehai (SP10), Zusanli (ST36) and Ashi-point on the affected side of the body were punctured with filiform needles or EA (2 Hz/100 Hz) for 30 min. In the moxibustion group, moxibustion was applied to the surrounding area of the affected joint for 60 min. The treatment was conducted once every other day for 4 weeks. The pain degree was assessed by using numerical rating scale (NRS) and the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) scale (0－240 points) was used to evaluate the severity of KOA. The ""Minimal Clinically Important Improvement (MCII)"" was used to assess the therapeutic effect after the treatment.
RESULTS


After the treatment, the scores of NRS, and the pain, stiffness, motor function and total scores of WOMAC were significantly decreased in the three groups compared with their own pre-treatment ( P <0.05), and were obviously lower in the EA and moxibustion groups than in the acupuncture group ( P <0.05), and those of the moxibustion group was notably lower than those of the acupuncture group ( P <0.05). Of the 28 cases in the acupuncture, EA and moxibustion groups, 11, 17 and 22 were effective, with the effective rate being 39.29%, 60.71% and 78.57%, respectively. The comprehensive therapeutic effect of the moxibustion group was significantly superior to that of the acupuncture and EA groups ( P <0.05).
CONCLUSION


All the three different kinds of acupuncture and moxibustion methods have positively regulatory effect on KOA, and moxibustion is the best for reducing the joint pain and stiffness, and improving the motor function.",2020,"The comprehensive therapeutic effect of the moxibustion group was significantly superior to that of the acupuncture and EA groups ( P <0.05).
","['knee osteoarthritis', 'knee osteoarthritis (KOA', 'A total of eight-four patients with KOA']","['acupuncture', 'acupuncture, electroacupuncture (EA) and moxibustion', 'acupuncture and moxibustion', 'acupuncture methods', 'moxibustion', 'acupuncture, EA and moxibustion', 'acupuncture group, EA group and moxibustion group']","['pain degree', 'comprehensive therapeutic effect', 'Neixiyan (EX-LE40), Dubi (ST35), Heding (EX-LE2), Liangqiu (ST34), Xuehai (SP10), Zusanli (ST36) and Ashi-point', 'effective rate', 'scores of NRS, and the pain, stiffness, motor function and total scores of WOMAC', 'numerical rating scale (NRS) and the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) scale']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",12.0,0.0291857,"The comprehensive therapeutic effect of the moxibustion group was significantly superior to that of the acupuncture and EA groups ( P <0.05).
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Basic Medicine, Hebei University of Chinese Medicine, Shijiazhuang 050091, China.'}, {'ForeName': 'Ye-Juan', 'Initials': 'YJ', 'LastName': 'Jia', 'Affiliation': 'School of Acupuncture-moxibustion and Tuina, Hebei University of Chinese Medicine, Shijiazhuang 050091, China.'}, {'ForeName': 'Jiu-Heng', 'Initials': 'JH', 'LastName': 'LÜ', 'Affiliation': 'School of Acupuncture-moxibustion and Tuina, Hebei University of Chinese Medicine, Shijiazhuang 050091, China.'}, {'ForeName': 'Jing-Xuan', 'Initials': 'JX', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-moxibustion and Tuina, Hebei University of Chinese Medicine, Shijiazhuang 050091, China.'}, {'ForeName': 'Zi-di', 'Initials': 'ZD', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture-moxibustion and Tuina, Hebei University of Chinese Medicine, Shijiazhuang 050091, China.'}, {'ForeName': 'Rui-Qing', 'Initials': 'RQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-moxibustion and Tuina, Hebei University of Chinese Medicine, Shijiazhuang 050091, China.'}, {'ForeName': 'Chun-Sheng', 'Initials': 'CS', 'LastName': 'Jia', 'Affiliation': 'School of Acupuncture-moxibustion and Tuina, Hebei University of Chinese Medicine, Shijiazhuang 050091, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.191015']
1611,32705833,[Ginger-partitioned moxibustion in the prevention of nausea and vomiting induced by chemotherapy in lung cancer：a randomized controlled trial].,"OBJECTIVE


To observe the effect of ginger-partitioned moxibustion intervention on gastrointestinal reaction, the quality of life, the counts of blood platelet (PLT) and white blood cells (WBC) after chemotherapy in lung cancer patients.
METHODS


The lung cancer patients treated with chemotherapy were randomized into observation group (30 cases) and control group (30 cases). In the control group, the intravenous injection with Tropisetron(5 mg) was given 1 h before chemotherapy. In the observation group, in addition to the same treatment as the control group, 2 hours after chemotherapy, ginger-partitioned moxibustion was applied to bilateral Zusanli (ST36), bilateral Neiguan (PC6) and bilateral Tianshu (ST25) for 20 min each time. The treatments were conducted once daily for 3 days. Separately, 2 days before chemotherapy, 24 h and 7 days after chemotherapy, the gastrointestinal reaction score and the score of the quality of life, the PLT and WBC counts were observed in the two groups.
RESULTS


The effective rate of the gastrointestinal reaction degree in the observation group were higher than those in the control group 24 h and 7 days after chemotherapy ( P <0.05). Twenty-four hours after chemotherapy, the score of the quality of life, the PLT and WBC counts were lower as compared with those before the treatment in both groups respectively( P <0.05). Seven days after chemotherapy, the score of the quality of life, the PLT and WBC counts in the observation group were higher than those in the control group ( P <0.05).
CONCLUSION


The ginger-partitioned moxibustion achieves the definite clinical effect of the prevention of nausea and vomiting induced by chemotherapy in lung cancer. This therapy is simple in operation, high in safety, absent in obvious adverse reactions and high in patient's compliance.",2020,"Twenty-four hours after chemotherapy, the score of the quality of life, the PLT and WBC counts were lower as compared with those before the treatment in both groups respectively( P <0.05).","['lung cancer patients', 'lung cancer patients treated with', 'lung cancer']","['chemotherapy, ginger-partitioned moxibustion was applied to bilateral Zusanli (ST36), bilateral Neiguan (PC6) and bilateral Tianshu (ST25', 'ginger-partitioned moxibustion intervention', 'ginger-partitioned moxibustion', 'chemotherapy', 'Ginger-partitioned moxibustion']","['gastrointestinal reaction, the quality of life, the counts of blood platelet (PLT) and white blood cells (WBC', 'nausea and vomiting', 'effective rate of the gastrointestinal reaction degree', 'score of the quality of life, the PLT and WBC counts', 'gastrointestinal reaction score and the score of the quality of life, the PLT and WBC counts']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0450522', 'cui_str': 'ST25'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0330694,"Twenty-four hours after chemotherapy, the score of the quality of life, the PLT and WBC counts were lower as compared with those before the treatment in both groups respectively( P <0.05).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Ya-Ling', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Rui-Yang', 'Initials': 'RY', 'LastName': 'Fu', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Jin-Xia', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'Guo', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Shou-Han', 'Initials': 'SH', 'LastName': 'Feng', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}, {'ForeName': 'Xin-Jun', 'Initials': 'XJ', 'LastName': 'Guan', 'Affiliation': 'Huzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University, Huzhou 313000, Zhejiang Province, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190568']
1612,32706812,The impact of a randomized controlled trial of a lifestyle intervention on postpartum physical activity among at-risk hispanic women: Estudio PARTO.,"AIMS


To assess the impact of a culturally modified, motivationally targeted, individually-tailored intervention on postpartum physical activity (PA) and PA self-efficacy among Hispanic women.
METHODS


Estudio PARTO was a randomized controlled trial conducted in Western Massachusetts from 2013-17. Hispanic women who screened positive for gestational diabetes mellitus were randomized to a Lifestyle Intervention (LI, n = 100) or to a comparison Health and Wellness (HW, n = 104) group during late pregnancy. Exercise goals in LI were to meet American College of Obstetrician & Gynecologists guidelines for postpartum PA. The Pregnancy Physical Activity Questionnaire (PPAQ) and the Self-Efficacy for Physical Activity Questionnaire were administered at 6 weeks, 6 months, and 1 year postpartum.
RESULTS


Compared to baseline levels, both groups had significant increases in moderate-to-vigorous PA at 6 months and one year postpartum (i.e., LI: mean change = 30.9 MET-hrs/wk, p = 0.05; HW: 27.6 MET-hrs/wk, p = 0.01), with only LI group experiencing significant increases in vigorous PA (mean change = 1.3 MET-hrs/wk, p = 0.03). Based on an intent-to-treat analysis using mixed effects models, we observed no differences in pattern of change in PA intensity and type over time between intervention groups (all p > 0.10). However, there was the suggestion of a greater decrease in sedentary activity in the LI group compared to the HW group (β = -3.56, p = 0.09).
CONCLUSIONS


In this randomized trial among high-risk Hispanic women, both groups benefitted from participation in a postpartum intervention.",2020,"Compared to baseline levels, both groups had significant increases in moderate-to-vigorous PA at 6 months and one year postpartum (i.e., LI: mean change =","['Hispanic women who screened positive for gestational diabetes mellitus', 'at-risk hispanic women', 'high-risk Hispanic women', 'Western Massachusetts from 2013-17', 'Hispanic women']","['Lifestyle Intervention (LI, n = 100) or to a comparison Health and Wellness (HW, n = 104) group during late pregnancy', 'lifestyle intervention', 'culturally modified, motivationally targeted, individually-tailored intervention']","['moderate-to-vigorous PA', 'Pregnancy Physical Activity Questionnaire (PPAQ) and the Self-Efficacy for Physical Activity Questionnaire', 'vigorous PA', 'PA intensity and type over time', 'sedentary activity', 'postpartum physical activity', 'postpartum physical activity (PA) and PA self-efficacy']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.0849279,"Compared to baseline levels, both groups had significant increases in moderate-to-vigorous PA at 6 months and one year postpartum (i.e., LI: mean change =","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Burkart', 'Affiliation': 'Department of Kinesiology, School of Public Health & Health Sciences, University of Massachusetts, Amherst, Massachusetts, United States of America.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Pekow', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health & Health Sciences, University of Massachusetts Amherst, Amherst, Massachusetts, United States of America.'}, {'ForeName': 'Milagros C', 'Initials': 'MC', 'LastName': 'Rosal', 'Affiliation': 'Division of Preventive and Behavioral Medicine, Department of Population & Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts, United States of America.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Braun', 'Affiliation': 'Department of Health and Exercise Science, College of Health and Human Sciences, Colorado State University, Fort Collins, Colorado, United States of America.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chasan-Taber', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health & Health Sciences, University of Massachusetts Amherst, Amherst, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0236408']
1613,32712307,A 24-month randomized controlled trial on the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with the ART approach.,"OBJECTIVE


To compare the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with atraumatic restorative treatment (ART) approach.
METHOD


Cavitated dentine caries lesions in preschool children were randomly allocated to two groups to be applied with either 38% silver diamine fluoride (SDF) solution or tonic water (control) ten weeks before being restored with the ART approach. Status of the restorations were assessed every six months by a blinded independent examiner. Multilevel logistic regression and multilevel survival analyses were conducted to assess the restoration success rates.
RESULTS


A total of 194 children (SDF group, 101; control group, 93) were included, with 260 and 249 ART restorations placed in the SDF and the control groups, respectively. At 24-month follow-up, 88 (87 %) and 84 (90 %) children remained in the SDF and the control groups, respectively. There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05). The success rate of ART restorations was associated with the class of restorations. Class I restorations had the highest success rate (∼50 %), followed by Class V (∼35 %), Class II (∼15 %) and Class III (<10 %). Besides, the mean time used to place an ART restoration in a SDF-treated caries lesion was shorter than that in untreated lesion (4.8 vs. 5.1 min, p = 0.006).
CONCLUSION


Prior SDF application does not significantly affect the success rate of ART restorations placed in primary teeth. Besides, it is faster to place ART restorations in caries lesions that have been previously treated with SDF.
CLINICAL SIGNIFICANCE


Prior application of silver diamine fluoride solution on cavitated dentine caries lesions in primary teeth can shorten the average time required to place an ART restoration while not jeopardizing the success rate of the restorations.",2020,There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05).,"['Cavitated dentine caries lesions in preschool children', 'primary teeth with atraumatic restorative treatment (ART) approach', '194 children (SDF group, 101; control group, 93) were included, with 260 and 249 ART restorations placed in the SDF and the control groups, respectively', 'cavitated dentine caries lesions in primary teeth', 'primary teeth with the ART approach']","['38% silver diamine fluoride (SDF) solution or tonic water (control) ten weeks before being restored with the ART approach', 'restoring untreated and SDF-treated dentine caries lesions', 'silver diamine fluoride solution']","['ART restoration success rates', 'highest success rate', 'success rates', 'mean time used to place an ART restoration in a SDF-treated caries lesion', 'success rate of ART restorations', 'success rate']","[{'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0452449', 'cui_str': 'Tonic water'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",194.0,0.0638187,There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05).,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Linlu', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China. Electronic address: edward-lo@hku.hk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103435']
1614,32713850,Self-directed multimedia process for delivering participant informed consent.,"OBJECTIVE


Obtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy and may fail to achieve the desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of self-directed multimedia delivery of participant consent.
DESIGN


It is a single-centre, randomised, prospective study to determine the efficacy, usability and acceptability of a self-directed multimedia consent process (intervention) compared with the traditional paper-based approach (control). The intervention was free of research staff, with computer-based finger-signed consent.
SETTING


Pathology blood collection services in Tasmania, Australia.
PARTICIPANTS


298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152).
OUTCOME MEASURES


Efficacy, usability and acceptability of the allocated consent process were assessed by a questionnaire.
RESULTS


All participants successfully completed the allocated interventions. Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all). Intervention participants were more likely to engage with the study information and spend more time on the consent process (p=<0.001 and p=0.006, respectively). Both groups reported similar levels of acceptability, although more control participants reported that the study information was too long (24% vs 14%; p=0.020).
CONCLUSION


A self-directed multimedia consent process is effective for achieving participant understanding and obtaining consent free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs and achieve informed consent in clinical research.",2020,"Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all).","['Pathology blood collection services in Tasmania, Australia', '298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152']","['self-directed multimedia consent process (intervention', 'traditional paper-based approach (control']","['Efficacy, usability and acceptability of the allocated consent process', 'likely to engage with the study information and spend more time on the consent process', 'efficacy, usability and acceptability', 'Efficacy parameters', 'levels of acceptability']","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",298.0,0.0393312,"Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all).","[{'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Chapman', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'McWhirter', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Armstrong', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Campbell', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Schultz', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Sharman', 'Affiliation': 'Menzies Institute for Medical Research, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia James.Sharman@utas.edu.au.'}]",BMJ open,['10.1136/bmjopen-2020-036977']
1615,32714001,Evaluation of a Novel Trocar-Site Closure Device in Laparoscopic Surgery.,"Background and Objectives


We evaluated the effectiveness and safety of EZ-Close TM  compared to those of hand suture for trocar-site closure according to obesity.
Methods


Fifty-four cases of laparoscopic colorectal surgery were enrolled. For the same patient, the right port site was closed using EZ-Close TM  and left port site was closed by hand suture among cases with port-site diameter ≥10 mm. Cases switched to use of a conventional fascial closure device or with closure time 120 s were considered failures. Closure time was analyzed according to body mass index (BMI) and abdominal wall thickness (AWT).
Results


The mean closure time was significantly shorter with EZ-Close TM  than with hand suture (87.9 ± 21.0 vs. 128.0 ± 59.0 s,  p  < 0.001). The number of failure cases was significantly lower with EZ-Close TM  than with hand suture (7 vs. 27,  p  < 0.001). The closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with BMI ≥ 25 and < 27 kg/m 2  (n = 15, 85.9 ± 19.8 vs. 135.6 ± 67.9 s,  p  < 0.014) and ≥ 27 kg/m 2  (n = 13, 85.1 ± 18.4 vs. 150.2 ± 70.6 s,  p  < 0.010). With respect to AWT, the closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with AWT ≥ 20 and < 26 mm (n = 12, 81.1 ± 11.5 vs. 142.3 ± 83.7 s,  p  = 0.023) and ≥ 26 mm (n = 17, 85.6 ± 22.6 vs. 160.2 ± 55.5,  p  < 0.001). No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
Conclusion


EZ-Close TM  could provide time efficiency in trocar-site closure, especially in obese patients.",2020,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","['obese patients', 'Methods\n\n\nFifty-four cases of laparoscopic colorectal surgery were enrolled', 'Laparoscopic Surgery']","['Novel Trocar-Site Closure Device', 'conventional fascial closure device', 'EZ-Close TM']","['number of failure cases', 'mean closure time', 'closure time of EZ-Close TM', 'No infection and herniation', 'Closure time', 'body mass index (BMI) and abdominal wall thickness (AWT']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C2712105', 'cui_str': 'Absence of signs and symptoms of infection'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0446081,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","[{'ForeName': 'Youngbae', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Soohwa', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kyoung-Won', 'Initials': 'KW', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dong-Hyuk', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Jeong-Heum', 'Initials': 'JH', 'LastName': 'Baek', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00033']
1616,32732787,Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial.,"BACKGROUND


Telephone call programs are a common intervention used to improve patients' transition to outpatient care after hospital discharge.
OBJECTIVE


To examine the impact of a follow-up telephone call program as a readmission reduction initiative.
RESEARCH DESIGN


Pragmatic randomized controlled real-world effectiveness trial.
SUBJECTS


We enrolled and randomized all patients discharged home from a hospital general medicine service to a follow-up telephone call program or usual care discharge. Patients discharged against medical advice were excluded. The intervention was a hospital program, delivering a semistructured follow-up telephone call from a nurse within 3-7 days of discharge, designed to assess understanding and provide education, and assistance to support discharge plan implementation.
MEASURES


Our primary endpoint was hospital inpatient readmission within 30 days identified by the electronic health record. Secondary endpoints included observation readmission, emergency department revisit, and mortality within 30 days, and patient experience ratings.
RESULTS


All 3054 patients discharged home were enrolled and randomized to the telephone call program (n=1534) or usual care discharge (n=1520). Using a prespecified intention-to-treat analysis, we found no evidence supporting differences in 30-day inpatient readmissions [14.9% vs. 15.3%; difference -0.4 (95% confidence interval, 95% CI), -2.9 to 2.1; P=0.76], observation readmissions [3.8% vs. 3.6%; difference 0.2 (95% CI, -1.1 to 1.6); P=0.74], emergency department revisits [6.1% vs. 5.4%; difference 0.7 (95% CI, -1.0 to 2.3); P=0.43], or mortality [4.4% vs. 4.9%; difference -0.5 (95% CI, -2.0 to 1.0); P=0.51] between telephone call and usual care groups.
CONCLUSIONS


We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.",2020,We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.,"['Patients discharged against medical advice were excluded', ""patients' transition to outpatient care after hospital discharge"", 'All 3054 patients discharged home were enrolled and randomized to the', 'We enrolled and randomized all patients discharged home from a hospital general medicine service to a follow-up telephone call program or usual care discharge']","['telephone call program (n=1534) or usual care discharge', 'Follow-up Telephone Call Program']","['30-day readmissions or mortality', 'observation readmission, emergency department revisit, and mortality within 30 days, and patient experience ratings', 'emergency department revisits', 'hospital inpatient readmission', 'mortality', '30-day inpatient readmissions', 'observation readmissions', '30-Day Readmissions (FUTR-30']","[{'cui': 'C1304701', 'cui_str': 'Patient self-discharge against medical advice'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",3054.0,0.401488,We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.,"[{'ForeName': 'Maame Yaa A B', 'Initials': 'MYAB', 'LastName': 'Yiadom', 'Affiliation': 'Departments of Emergency Medicine.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Domenico', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hasselblad', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Neesha', 'Initials': 'N', 'LastName': 'Choma', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tucker-Marlow', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Monisha C', 'Initials': 'MC', 'LastName': 'Bhatia', 'Affiliation': 'School of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Johnston', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Tina V', 'Initials': 'TV', 'LastName': 'Hartert', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Departments of Emergency Medicine.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Medicine, Vanderbilt University.'}]",Medical care,['10.1097/MLR.0000000000001353']
1617,32689752,[Application value of non-invasive ventilation combined with high flow nasal cannula oxygen therapy in sequential treatment of patients with chronic obstructive pulmonary disease after mechanical ventilation].,"Objective:  To investigate the value of non-invasive ventilation (NIV) combined with high flow nasal cannula oxygen therapy (HFNCO) in sequential treatment of patients with chronic obstructive pulmonary disease after mechanical ventilation.  Methods:  Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) patients with invasive mechanical ventilation (MV) and successful withdrawal admitted into Huxi Affiliated Hospital of Jining Medical College from January 2018 to December 2019 were enrolled for perspective study. The patients were divided into treatment group ( n= 40) and control group ( n= 33) by random number table method. The treatment group was given NIV and HFNCO, the control group was given NIV treatment alone. Bedside ultrasound was used to measure the patients' diaphragmatic motion, and the differences between the two groups of patients before treatment, 24, 48 and 72 h after treatment were compared in diaphragmatic excursions during quiet breathing (DEq), diaphragmatic excursions during deep breathing(DEd), diaphragmatic shallow fast breathing index (D-RSBI), arterial oxygen partial pressure (PaO(2)), arterial partial pressure of carbon dioxide (PaCO(2)), re-tracheal intubation rate, mortality rate for 28 days and average duration of NPPV treatment within 3 days.  Results:  There were no statistically significant differences in DEq, DEd, D-RSBI, PaO(2) and PaCO(2) between the two groups before treatment (all  P> 0.05). After 24 h treatment, DEd decreased in both groups, D-RSBI increased in both groups, However, D-RSBI [(1.33±0.56) vs (1.62±0.59) times·min(-1)·mm(-1)] in the treatment group was significantly lower than the control group,  P= 0.034. After 72 h treatment, DEd [(41.4±8.1) vs (37.8±6.0) mm] was significantly higher than the control group, D-RSBI [(1.02±0.27) vs (1.22±0.43) times·min(-1)·mm(-1)] was significantly lower than the control group (all  P< 0.05). The average duration of NIV treatment time [(7.5±1.2) vs (9.3±2.6) h] in the treatment group was significantly shorter than that in the control group ( P< 0.01). There were no statistically significant differences in PaO(2), PCO(2), re-tracheal intubation rate and the mortality rate of 28 days.  Conclusion:  NIV combined with HFNCO sequential therapy can effectively relieve diaphragm fatigue and promote recovery of respiratory muscle strength, and it's better than NIV alone.",2020,"There were no statistically significant differences in DEq, DEd, D-RSBI, PaO(2) and PaCO(2) between the two groups before treatment (all  P> 0.05).","['Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) patients with invasive mechanical ventilation (MV) and successful withdrawal admitted into Huxi Affiliated Hospital of Jining Medical College from January 2018 to December 2019 were enrolled for perspective study', 'patients with chronic obstructive pulmonary disease after mechanical ventilation']","['non-invasive ventilation combined with high flow nasal cannula oxygen therapy', 'HFNCO sequential therapy', 'non-invasive ventilation (NIV) combined with high flow nasal cannula oxygen therapy (HFNCO', 'times·min(-1)·mm(-1']","['diaphragm fatigue and promote recovery of respiratory muscle strength', 'diaphragmatic excursions during quiet breathing (DEq), diaphragmatic excursions during deep breathing(DEd), diaphragmatic shallow fast breathing index (D-RSBI), arterial oxygen partial pressure (PaO(2)), arterial partial pressure of carbon dioxide (PaCO(2)), re-tracheal intubation rate, mortality rate for 28 days and average duration of NPPV treatment within 3 days', 'DEq, DEd, D-RSBI, PaO(2) and PaCO(2', 'PaO(2), PCO(2), re-tracheal intubation rate and the mortality rate of 28 days', 'average duration of NIV treatment time', 'DEd', 'D-RSBI']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0241827,"There were no statistically significant differences in DEq, DEd, D-RSBI, PaO(2) and PaCO(2) between the two groups before treatment (all  P> 0.05).","[{'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Yang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary Medicine, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Meng', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'W B', 'Initials': 'WB', 'LastName': 'Yang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'G Z', 'Initials': 'GZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'Q B', 'Initials': 'QB', 'LastName': 'Shi', 'Affiliation': 'Department of Emergency, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Intensive Care Unit, Huxi Hospital Affiliated to Jining Medical College, Heze 274300, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200306-00616']
1618,32689756,[Effect and underling mechanism of 6% hydroxyethyl starch 130/0.4 on serum albumen in trauma orthopedic patients during operation].,"Objective:  To investigate the effect of 6% hydroxyethyl starch 130/0.4(HES) on protein in severe trauma orthopedic patients after acute hemodilution.  Methods:  Fourty-eight severe trauma patients who met the inclusion criteria were selected from June 2018 to December 2018 in Yantaishan Hospital, and were randomly divided into two groups ( n= 24): group A and group B. Group A was ringer's sodium lactate control group, and group B was HES treatment group. After the tracheal intubation, the patients of group A were infused with 10% blood volume of sodium lactate ringer at 0.5 ml·kg(-1)·min(-1), and the patients in group B were infused with 10% blood volume of HES at 0.5 ml·kg(-1)·min(-1). Total protein (TP), human serum albumin (HSA), numbers of circulating endothelium cells (CEC), C-reactive protein (CRP), and serum levels of tumor necrosis factor-alpha (TNF-α), interleukin (IL)-10 and IL-6 were measured immediately after acute hemodilution (T(0)), 24 hours (T(1)) and 48 hours (T(2)) after acute hemodilution. After infusion into human body, HES bond to HSA, and fluorescence spectroscopy was used to analyze the binding relationship between HES and HSA in order to further study the effects of HES on HSA.  Results:  The HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0) of group A were (38±5) g/L, (66±5) g/L, (5.5±0.4)/0.9 μl, (24±5) μg/L, (8.9±0.8) μg/L, (44±6) μg/L, (13.6±1.4) mg/L; While at T(1) were (33±5) g/L, (60±6) g/L, (10.2±0.7)/0.9 μl, (87±9) μg/L, (38.8±2.3) μg/L, (57±7) μg/L, (23.4±2.4) mg/L. The HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0) of group B were(38±4)g/L, (66±5) g/L, (5.4±0.6)/0.9 μl, (24±6) μg/L, (9.1±0.9) μg/L, (45±6) μg/L, (13.4±1.8) mg/L; While at T(1) were (35±5)g/L, (62±5)g/L, (7.4±0.6)/0.9 μl, (70±8) μg/L, (29.5±3.1) μg/L, (72±6) μg/L, (19.7±2.2) mg/L. HSA and TP decreased at T(1) in group A as compared with T(0) ( P< 0.05), contrarily CEC increased significantly at T(1), TNF-ɑ, IL-6, IL-10 and CRP augmented at T(1) and T(2) in two groups ( P< 0.05). In comparison with the patients of group A, CEC decreased significantly at T(1) ( P< 0.05). TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2) ( P< 0.05), but IL-10 increased at T(1) and T(2) in group B ( P< 0.05). The secondary structure of HSA changed after HES was added in the HES solution. The fluorescence intensity of HSA decreased with the increase of HES concentration,which suggested that HES induced HSA fluorescence quenching. HES could bind to Trp-214 residue in HSA at a molecular ration of 1∶1.  Conclusions:  6% HES reduces the occurrence of low protein level in severe trauma patients after operation. HES could bind to Trp-214 amino acid residue in HSA and form the complex at a molecular ratio of 1∶1. The formation of HES-HSA complex increases the volume of HES, avoids the vascular leakage, protects the vascular endothelial cells, and induces anti-inflammatory immunity in the patients with capillary syndrome.",2020,"TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2)","['severe trauma orthopedic patients after acute hemodilution', 'severe trauma patients after operation', 'trauma orthopedic patients during operation', 'patients with capillary syndrome', 'Fourty-eight severe trauma patients who met the inclusion criteria were selected from June 2018 to December 2018 in Yantaishan Hospital']","['hydroxyethyl starch 130/0.4(HES', ""ringer's sodium lactate control group, and group B was HES treatment group"", 'HES', 'T(0', 'sodium lactate ringer at 0.5 ml·kg(-1)·min(-1', 'hydroxyethyl starch']","['serum albumen', 'CEC decreased significantly at T(1', 'Total protein (TP), human serum albumin (HSA), numbers of circulating endothelium cells (CEC), C-reactive protein (CRP), and serum levels of tumor necrosis factor-alpha (TNF-α), interleukin (IL)-10 and IL-6 were measured immediately after acute hemodilution (T(0)), 24 hours (T(1)) and 48 hours (T(2', 'contrarily CEC increased significantly at T(1), TNF-ɑ, IL-6, IL-10 and CRP augmented at T(1) and T(2', 'IL-10 increased at T(1) and T(2', 'TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2', 'HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0) of group B were(38±4)g/L, (66±5', 'fluorescence intensity of HSA', 'occurrence of low protein level', 'HSA, TP, CEC, TNF-α, IL-6, IL-10, CRP at T(0']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0142874', 'cui_str': 'Sodium lactate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018763', 'cui_str': 'Health Systems Agencies'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}]",,0.0377761,"TNF-ɑ, IL-6, CRP reduced significantly at T(1) and T(2)","[{'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Qu', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'X N', 'Initials': 'XN', 'LastName': 'Yi', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Shao', 'Affiliation': 'Department of Anesthesiology, Yantaishan Hospital, Yantai 264008, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Oncology, Yantaishan Hospital, Yantai 264008, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191114-02475']
1619,31308252,"Small-protein Enrichment Assay Enables the Rapid, Unbiased Analysis of Over 100 Low Abundance Factors from Human Plasma.","Unbiased and sensitive quantification of low abundance small proteins in human plasma ( e.g.  hormones, immune factors, metabolic regulators) remains an unmet need. These small protein factors are typically analyzed individually and using antibodies that can lack specificity. Mass spectrometry (MS)-based proteomics has the potential to address these problems, however the analysis of plasma by MS is plagued by the extremely large dynamic range of this body fluid, with protein abundances spanning at least 13 orders of magnitude. Here we describe an enrichment assay (SPEA), that greatly simplifies the plasma dynamic range problem by enriching small-proteins of 2-10 kDa, enabling the rapid, specific and sensitive quantification of >100 small-protein factors in a single untargeted LC-MS/MS acquisition. Applying this method to perform deep-proteome profiling of human plasma we identify C5ORF46 as a previously uncharacterized human plasma protein. We further demonstrate the reproducibility of our workflow for low abundance protein analysis using a stable-isotope labeled protein standard of insulin spiked into human plasma. SPEA provides the ability to study numerous important hormones in a single rapid assay, which we applied to study the intermittent fasting response and observed several unexpected changes including decreased plasma abundance of the iron homeostasis regulator hepcidin.",2019,Applying this method to perform deep-proteome profiling of human plasma we identify C5ORF46 as a previously uncharacterized human plasma protein.,[],[],['Mass spectrometry '],[],[],"[{'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}]",,0.0181029,Applying this method to perform deep-proteome profiling of human plasma we identify C5ORF46 as a previously uncharacterized human plasma protein.,"[{'ForeName': 'Dylan J', 'Initials': 'DJ', 'LastName': 'Harney', 'Affiliation': '‡Charles Perkins Centre, School of Life and Environmental Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': '¶Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Zhiduan', 'Initials': 'Z', 'LastName': 'Su', 'Affiliation': '‡Charles Perkins Centre, School of Life and Environmental Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Hatchwell', 'Affiliation': '‡Charles Perkins Centre, School of Life and Environmental Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': '¶Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hocking', 'Affiliation': '§Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'James', 'Affiliation': '‡Charles Perkins Centre, School of Life and Environmental Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Larance', 'Affiliation': '‡Charles Perkins Centre, School of Life and Environmental Sciences, University of Sydney, Sydney, Australia mark.larance@sydney.edu.au.'}]",Molecular & cellular proteomics : MCP,['10.1074/mcp.TIR119.001562']
1620,31897428,Blocking FcRn in humans reduces circulating IgG levels and inhibits IgG immune complex-mediated immune responses.,"The neonatal crystallizable fragment receptor (FcRn) functions as an intracellular protection receptor for immunoglobulin G (IgG). Recently, several clinical studies have reported the lowering of circulating monomeric IgG levels through FcRn blockade for the potential treatment of autoimmune diseases. Many autoimmune diseases, however, are derived from the effects of IgG immune complexes (ICs). We generated, characterized, and assessed the effects of SYNT001, a FcRn-blocking monoclonal antibody, in mice, nonhuman primates (NHPs), and humans. SYNT001 decreased all IgG subtypes and IgG ICs in the circulation of humans, as we show in a first-in-human phase 1, single ascending dose study. In addition, IgG IC induction of inflammatory pathways was dependent on FcRn and inhibited by SYNT001. These studies expand the role of FcRn in humans by showing that it controls not only IgG protection from catabolism but also inflammatory pathways associated with IgG ICs involved in a variety of autoimmune diseases.",2019,"We generated, characterized, and assessed the effects of SYNT001, a FcRn-blocking monoclonal antibody, in mice, nonhuman primates (NHPs), and humans.",[],[],['IgG subtypes and IgG ICs'],[],[],"[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0003313', 'cui_str': 'Immune complex'}]",,0.0359691,"We generated, characterized, and assessed the effects of SYNT001, a FcRn-blocking monoclonal antibody, in mice, nonhuman primates (NHPs), and humans.","[{'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Blumberg', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Humphries', 'Affiliation': 'Biologics Consulting, Alexandria, VA 22314, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Jones', 'Affiliation': 'BioProcess Technology Consultants, Woburn, MA 01801, USA.'}, {'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Pearce', 'Affiliation': 'Biologics Consulting, Alexandria, VA 22314, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Holgate', 'Affiliation': 'Abzena, Babraham, Cambridge, CB22 3AT, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hearn', 'Affiliation': 'Abzena, Babraham, Cambridge, CB22 3AT, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cheung', 'Affiliation': 'New York Structural Biology Center, New York, NY 10027, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mahmood', 'Affiliation': 'New York Structural Biology Center, New York, NY 10027, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Del Tito', 'Affiliation': 'Biologics Consulting, Alexandria, VA 22314, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Graydon', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Stolz', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bitonti', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Purohit', 'Affiliation': 'BioProcess Technology Consultants, Woburn, MA 01801, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Graaf', 'Affiliation': 'Syntimmune Inc., Boston, MA 02116, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kacena', 'Affiliation': 'BioBridges, Wellesley, MA 02481, USA.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Andersen', 'Affiliation': 'Department of Immunology and Centre for Immune Regulation, Oslo University Hospital Rikshospitalet and University of Oslo, Oslo 0424, Norway.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Christianson', 'Affiliation': 'The Jackson Laboratory, Bar Harbor, ME 04609, USA.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Roopenian', 'Affiliation': 'The Jackson Laboratory, Bar Harbor, ME 04609, USA.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Hubbard', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Gandhi', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lasseter', 'Affiliation': 'Clinical Pharmacology of Miami, Miami, FL 33014, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pyzik', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Blumberg', 'Affiliation': ""Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}]",Science advances,['10.1126/sciadv.aax9586']
1621,32693310,The influence of type of feedback during tablet-based delivery of intensive treatment for childhood apraxia of speech.,"PURPOSE


One of the key principles of motor learning supports using knowledge of results feedback (KR, i.e., whether a response was correct / incorrect only) during high intensity motor practice, rather than knowledge of performance (KP, i.e., whether and how a response was correct/incorrect). In the future, mobile technology equipped with automatic speech recognition (ASR) could provide KR feedback, enabling this practice to move outside the clinic, supplementing speech pathology sessions and reducing burden on already stretched speech-language pathology resources. Here, we employ a randomized controlled trial design to test the impact of KR vs KP feedback on children's response to the Nuffield Dyspraxia Programme 3, delivered through an android tablet. At the time of testing, ASR was not feasible and so correctness of responses was decided by the treating clinician.
METHOD


Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS. Both groups attended a university clinic for 1-hr therapy sessions 4 days a week for 3 weeks. One group received high frequency feedback comprised of both KR and KP, in the style of traditional, face-to-face intensive intervention on all days. The other group received high frequency KR + KP feedback on 1 day per week and high frequency KR feedback on the other 3 days per week, simulating the service delivery model of one clinic session per week supported by tablet-based home practice.
RESULTS


Both groups had significantly improved speech outcomes at 4-months post-treatment. Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment. Heterogeneity in response to intervention within the groups suggests that other factors, not measured here, may be having a substantive influence on response to intervention and feedback type.
CONCLUSION


Mobile technology has the potential to increase motivation and engagement with therapy and to mitigate barriers associated with distance and access to speech pathology services. Further research is needed to explore the influence of type and frequency of feedback on motor learning, optimal timing for transitioning from KP to KR feedback, and how these parameters interact with task, child and context-related factors.",2020,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"['childhood apraxia of speech', 'Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS']","['KR vs KP feedback', 'mobile technology equipped with automatic speech recognition (ASR', 'high frequency KR + KP feedback', 'high frequency feedback comprised of both KR and KP']",['speech outcomes'],"[{'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0201653,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'McKechnie', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia; Faculty of Health, University of Canberra, Bruce, ACT, Australia. Electronic address: Jacqui.McKechnie@canberra.edu.au.'}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Ahmed', 'Affiliation': 'Texas A&M University at Qatar, Doha, Qatar; Faculty of Engineering, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gutierrez-Osuna', 'Affiliation': 'Texas A & M University, College Station, TX, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCabe', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Kirrie J', 'Initials': 'KJ', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106026']
1622,32694457,"Effects of Predischarge Patient Education Combined With Postdischarge Follow-Ups on Self-Care, Readmission, Sleep, and Depression in Patients With Heart Failure.","BACKGROUND


Patients with heart failure rarely engage in adequate self-care. Greater emphasis on self-care discharge readiness is needed.
PURPOSE


This study examined the effects of a predischarge educational program combined with 1 year of postdischarge follow-up on self-care behaviors, readmission, sleep quality, and depression in patients with heart failure.
METHODS


A longitudinal, nonequivalent two-group pretest-posttest design was used. The intervention group received tailored education and follow-ups, whereas the control group received routine predischarge heart-failure education from direct care nurses only. Measurements included the self-care maintenance and self-care management subscales of the Self-Care of Heart Failure Index, Pittsburg Sleep Quality Index, Patient Health Questionnaire-9, and readmission rate. Data obtained at baseline and at 1, 3, 6, and 12 months postdischarge were analyzed using linear mixed models with both intention-to-treat and per-protocol approaches. The propensity score was used to adjust for the confounding effects of the New York Heart Association functional class and left ventricular ejection fraction.
RESULTS


Of the 62 patients with heart failure (28 in the intervention group and 34 in the control group) who were sampled at baseline, 47 (n = 25 vs. n = 22) provided data over the entire course of this 1-year study (76% retention rate). The per-protocol analysis did not find significant differences for any variables. However, the intention-to-treat analysis showed that the intervention group significantly improved in self-care maintenance at 6 months and self-care management at 12 months after hospital discharge, with fewer, albeit not significantly fewer, first and subsequent hospital readmissions than the control group.
CONCLUSIONS/IMPLICATIONS FOR PRACTICE


The effect of this intervention was not found to be substantial, indicating a need to design more efficacious and powerful interventions. Hospitalized patients must receive patient education before discharge to foster their self-care knowledge and skills regarding self-care at home. Strategies are needed to help nurses provide patient education in a time-efficient manner.",2020,The per-protocol analysis did not find significant differences for any variables.,"['Hospitalized patients', 'Patients with heart failure rarely engage in adequate self-care', 'patients with heart failure', '62 patients with heart failure ', 'Patients With Heart Failure']","['tailored education and follow-ups, whereas the control group received routine predischarge heart-failure education from direct care nurses only', 'Predischarge Patient Education Combined With Postdischarge Follow-Ups', 'predischarge educational program']","['self-care maintenance', 'self-care behaviors, readmission, sleep quality, and depression', 'hospital readmissions', 'self-care maintenance and self-care management subscales of the Self-Care of Heart Failure Index, Pittsburg Sleep Quality Index, Patient Health Questionnaire-9, and readmission rate', 'Self-Care, Readmission, Sleep, and Depression']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1828111', 'cui_str': 'Heart failure education'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",62.0,0.0320725,The per-protocol analysis did not find significant differences for any variables.,"[{'ForeName': 'Hsing-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'PhD, RN, Associate Professor, Department of Nursing, College of Medicine, National Cheng Kung University, Taiwan, ROC.'}, {'ForeName': 'Shan-Tair', 'Initials': 'ST', 'LastName': 'Wang', 'Affiliation': 'PhD, Deputy Superintendent, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi City, Taiwan.'}, {'ForeName': 'Shyh-Jong', 'Initials': 'SJ', 'LastName': 'Wu', 'Affiliation': 'PhD, Associate Professor, Department of Medical Laboratory Science and Biotechnology, Kaohsiung Medical University, Taiwan, ROC.'}, {'ForeName': 'Chee-Siong', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'MD, Lecturer, Division of Cardiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan, ROC.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Fetzer', 'Affiliation': 'PhD, RN, CNL, CCRN, Professor, Department of Nursing, University of New Hampshire, USA.'}, {'ForeName': 'Liang-Miin', 'Initials': 'LM', 'LastName': 'Tsai', 'Affiliation': ''}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000395']
1623,32700396,Effect of cilostazol on carotid plaque volume measured by three-dimensional ultrasonography in patients with type 2 diabetes: The FANCY study.,"AIMS


To conduct a prospective randomized study to evaluate cilostazol, a phosphodiesterase 3 inhibitor, and compare it with aspirin for the prevention of the progression of atherosclerosis in patients with type 2 diabetes (T2D).
MATERIALS AND METHODS


Fifty patients with T2D and carotid atherosclerotic plaques were randomly assigned to either a 200 mg/d cilostazol (CTZ) group or a 100 mg/d aspirin (ASA) group for 6 months. The primary endpoint was change in plaque volume measured by carotid three-dimensional ultrasonography. The secondary endpoints were changes in carotid intima-media thickness (IMT) and endothelial function, assessed by laser Doppler.
RESULTS


Twenty-four patients in the CTZ group and 23 in the ASA group were included in the final analysis. The mean ± SD age of male (n = 20) and female (n = 16) patients was 62.2 and 59.1 years, respectively. The total plaque volume was slightly decreased in the CTZ group (from 183.8 ± 52.5 to 181.5 ± 54.0 mm 3  ; P = .567), but significantly increased in the ASA group (from 112.9 ± 21.2 to 128.5 ± 23.3 mm 3  ; P = .043). A significant regression in the maximum IMT was observed only in the CTZ group (right: from 2.19 ± 0.17 to 1.96 ± 0.12 mm; left: from 2.02 ± 0.20 to 1.72 ± 0.19 mm). The CTZ group exhibited an increase in HDL cholesterol and a decrease in triglycerides and liver enzymes.
CONCLUSIONS


Cilostazol treatment for 6 months significantly attenuated the progression of carotid plaque compared with aspirin in patients with T2D (NCT03248401).",2020,"The total plaque volume was slightly decreased in the CTZ group (from 183.8 ± 52.5 to 181.5 ± 54.0 mm 3  , P = 0.567), but significantly increased in the ASA group (from 112.9 ± 21.2 to 128.5 ± 23.3 mm 3  , P = 0.043).","['mean age of male (n\xa0=\xa020) and female (n\xa0=\xa016) patients was 62.2 and 59.1\u2009years, respectively', 'Fifty patients with T2D and carotid atherosclerotic plaques', 'patients with type 2 diabetes', 'patients with type 2 diabetes (T2D']","['cilostazol', 'aspirin', '200 mg/day cilostazol (CTZ) or 100 mg/day aspirin (ASA', 'CTZ', 'cilostazol, a phosphodiesterase III inhibitor']","['total plaque volume', 'plaque volume', 'maximum IMT', 'HDL-cholesterol', 'carotid plaque volume', 'progression of carotid plaque', 'triglycerides and liver enzymes', 'carotid intima-media thickness (IMT) and endothelial functions assessed by laser Doppler']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0292144', 'cui_str': 'Phosphodiesterase III'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler'}]",50.0,0.059515,"The total plaque volume was slightly decreased in the CTZ group (from 183.8 ± 52.5 to 181.5 ± 54.0 mm 3  , P = 0.567), but significantly increased in the ASA group (from 112.9 ± 21.2 to 128.5 ± 23.3 mm 3  , P = 0.043).","[{'ForeName': 'Dong-Hwa', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Chun', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Han Mi', 'Initials': 'HM', 'LastName': 'Yun', 'Affiliation': 'Physiologic Diagnostic Laboratory, Vascular Laboratory, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14147']
1624,32702315,"Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial.","BACKGROUND


Peanut allergy is the leading cause of food-related anaphylaxis. Current management options can negatively affect food allergy-related quality of life. We aimed to investigate the efficacy of an investigational oral biologic drug (AR101).
METHODS


The AR101 Trial in Europe Measuring Oral Immunotherapy Success in peanut-allergic children (ARTEMIS) trial was a multicentre, double-blind, randomised, placebo-controlled phase 3 trial done at 18 hospitals in Ireland, France, Germany, Italy, Spain, Sweden, and the UK. Children and adolescents with peanut allergy, aged 4-17 years, who developed dose-limiting symptoms to 300 mg or less peanut protein (equivalent to approximately one peanut kernel) during a double-blind placebo-controlled food challenge test at study entry were enrolled. Participants were randomly assigned (3:1) to receive daily doses of either AR101 oral immunotherapy (AR101 group) or a taste-masked placebo (placebo group). All participants, investigators, and care providers were masked to treatment allocation until the study was completed. Doses were increased every 2 weeks over 6 months until a dose of 300 mg was reached and maintained for 3 months. The primary endpoint was the proportion of participants in the intention-to-treat or safety population (defined as those participants who had been randomly assigned and had received at least one dose of the assigned drug) who could consume a single dose of 1000 mg (cumulative dose 2043 mg) peanut protein without developing dose-limiting allergic symptoms at an exit double-blind placebo-controlled food challenge after 9 months of treatment. Additional endpoints included safety (ie, the frequency and severity of adverse events) and changes in food allergy-related quality of life, assessed by use of age-appropriate Food Allergy Quality of Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM). The study is registered with ClinicalTrials.gov, NCT03201003, and is completed.
FINDINGS


Between June 12, 2017, and Feb 15, 2018, 227 patients were screened, of whom 175 were randomly assigned to the AR101 group (n=132) and the placebo group (n=43). All primary and secondary endpoints were met. 77 (58%) of 132 participants in the AR101 group tolerated 1000 mg peanut protein at the exit food challenge versus one (2%) of 43 participants in the placebo group (AR101-placebo treatment difference 56·0% [95% CI 44·1-65·2], p<0·0001). Adverse events were reported by almost all participants. The maximum severity of adverse events reported was mild or moderate for most participants who received AR101 (mild, 66 [50%] of 132 participants; moderate, 63 [48%]; and severe, one [1%]) or placebo (mild, 24 [56%] of 43 participants; moderate, 18 [42%]; severe, none). Participants aged 8-12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains. Additionally, participants in the AR101 group and their caregivers reported improvements that exceeded the minimum clinically important difference in FAIM domains related to the perceived likelihood and outcomes of a severe allergic reaction.
INTERPRETATION


AR101 oral immunotherapy treatment led to rapid desensitisation to peanut protein, with a predictable safety profile that improved with treatment, and an associated improvement in self-reported and caregiver-reported food allergy-related quality of life. These patient-oriented outcomes provide invaluable data to help physicians, patients, and caregivers make informed, shared decisions on the management of peanut allergy.
FUNDING


Aimmune Therapeutics.",2020,Participants aged 8-12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains.,"['European children with a peanut allergy (ARTEMIS', 'peanut-allergic children', 'Between June 12, 2017, and Feb 15, 2018, 227 patients were screened, of whom 175 were randomly assigned to the AR101 group (n=132) and the', 'Children and adolescents with peanut allergy, aged 4-17 years, who developed dose-limiting symptoms to 300 mg or less peanut protein (equivalent to approximately one peanut kernel) during a double-blind placebo-controlled food challenge test at study entry were enrolled', '18 hospitals in Ireland, France, Germany, Italy, Spain, Sweden, and the UK']","['AR101 oral immunotherapy (AR101 group) or a taste-masked placebo (placebo', 'investigational oral biologic drug (AR101', 'could consume a single dose of 1000 mg (cumulative dose 2043 mg) peanut protein without developing dose-limiting allergic symptoms at an exit double-blind placebo', 'oral immunotherapy with AR101', 'placebo']","['maximum severity of adverse events', 'proportion of participants in the intention-to-treat or safety population', 'Adverse events', 'safety (ie, the frequency and severity of adverse events) and changes in food allergy-related quality of life, assessed by use of age-appropriate Food Allergy Quality of Life Questionnaires', 'Efficacy and safety', 'severe allergic reaction', 'FAIM domains', 'FAQLQs) and the Food Allergy Independent Measure (FAIM']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4553887', 'cui_str': 'Biologics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",227.0,0.78594,Participants aged 8-12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': ""O'B Hourihane"", 'Affiliation': 'Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland; Paediatrics and Child Health, INFANT Centre and HRB Clinical Research Facility, University College Cork, Cork, Ireland.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Allyah', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'Hospital Clínico San Carlos, UCM, IDISSC, ARADyAL, Madrid, Spain.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'Imperial College, London, London, UK.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Blumchen', 'Affiliation': 'Department of Children and Adolescent Medicine, Division of Allergology, Pneumology and Cystic Fibrosis, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': ""Clinical Science and Education, Karolinska Institutet, Sachs' Children and Youth Hospital, Sodersjukhuset, Stockholm, Sweden.""}, {'ForeName': 'Maria D', 'Initials': 'MD', 'LastName': 'Ibáñez', 'Affiliation': 'H. Infantil Universitario Niño Jesús, ARADyAL-RETICs Instituto de Salud Carlos III, IIS-P, FibHNJ, Madrid, Spain.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Deschildre', 'Affiliation': 'Université de Lille, CHU Lille, Pediatric Pulmonology and Allergy Unit, Hôpital Jeanne de Flandre, Lille, France.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Muraro', 'Affiliation': 'Food Allergy Referral Centre Veneto Region, Department of Woman and Child Health, Padua University Hospital, Padua, Italy.'}, {'ForeName': 'Vibha', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust and Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Erlewyn-Lajeunesse', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Zubeldia', 'Affiliation': 'Hospital GU Gregorio Marañón, and Biomedical Research Network on Rare Diseases, Madrid, Spain.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'De Blay', 'Affiliation': 'University Hospital Strasbourg, Strasbourg, France.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Sauvage', 'Affiliation': 'Hôpital Saint-Vincent, Saint Antoine, Lille, France.'}, {'ForeName': 'Aideen', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': ""National Children's Research Centre, Dublin, Ireland.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'James Paget University Hospitals NHS Foundation Trust, Great Yarmouth, UK.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boralevi', 'Affiliation': 'CIC 1401, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland; Department of Pediatrics and Pediatric Infectious Diseases, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': ""O'Neill"", 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Norval', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vereda', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Skeel', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Adelman', 'Affiliation': 'Aimmune Therapeutics, Brisbane, CA, USA; Department of Medicine, University of California San Francisco, San Francisco, CA, USA. Electronic address: dadelman@aimmune.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'du Toit', 'Affiliation': ""Evelina London, Children's Allergy Service, Guy's and St Thomas' Hospital, London, UK; Department of Women and Children's Health (Paediatric Allergy), School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30234-0']
1625,32703808,"When possible, report a Fisher-exact  P  value and display its underlying null randomization distribution.","In randomized experiments, Fisher-exact  P  values are available and should be used to help evaluate results rather than the more commonly reported asymptotic  P  values. One reason is that using the latter can effectively alter the question being addressed by including irrelevant distributional assumptions. The Fisherian statistical framework, proposed in 1925, calculates a  P  value in a randomized experiment by using the actual randomization procedure that led to the observed data. Here, we illustrate this Fisherian framework in a crossover randomized experiment. First, we consider the first period of the experiment and analyze its data as a completely randomized experiment, ignoring the second period; then, we consider both periods. For each analysis, we focus on 10 outcomes that illustrate important differences between the asymptotic and Fisher tests for the null hypothesis of no ozone effect. For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value. For the other outcomes, the Fisher-exact null randomization distribution substantially differed from the bell-shaped one assumed by the asymptotic  t  test. Our conclusions: When researchers choose to report  P  values in randomized experiments, 1) Fisher-exact  P  values should be used, especially in studies with small sample sizes, and 2) the shape of the actual null randomization distribution should be examined for the recondite scientific insights it may reveal.",2020,"For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value.",[],[],[],[],[],[],,0.0315853,"For some outcomes, the traditional  P  value based on the approximating asymptotic Student's  t  distribution substantially subceeded the minimum attainable Fisher-exact  P  value.","[{'ForeName': 'M-A C', 'Initials': 'MC', 'LastName': 'Bind', 'Affiliation': 'Department of Statistics, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138; ma.bind@mail.harvard.edu.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Rubin', 'Affiliation': 'Yau Center for Mathematical Sciences, Tsinghua University, Beijing 100084, China.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1915454117']
1626,32705393,Inspiratory muscle training improves cerebrovascular and postural control responses during orthostatic stress in older women.,"PURPOSE


We aimed to investigate the effect of inspiratory muscle training (IMT) on, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress, in older women.
METHODS


Fourteen elderly women were assigned to perform IMT at 50% of maximal inspiratory pressure (MIP) (IMT group, n = 8) or placebo training at 5% MIP (Sham group, n = 6), in a counter-balanced order, using an inspiratory threshold device for 4 weeks. During the protocol, MIP was tested weekly once. In a second visit, blood pressure, heart rate, stroke volume, cardiac output, middle cerebral artery blood flow velocity (MCAv), and ventilation parameters were recorded continuously at rest and during orthostatic stress testing, which was conducted on a force plate to measure center-of-pressure (COP) oscillations (postural balance) and the electromyographic activity of the right medial gastrocnemius and tibialis anterior.
RESULTS


IMT increased MIP from second to 4th week. The drops in MCAv, stroke volume, and cardiac output, as well as COP displacements during initial orthostasis decreased post-IMT.
CONCLUSION


IMT improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress in older women.",2020,"IMT improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress in older women.","['older women', 'Fourteen elderly women']","['IMT at 50% of maximal inspiratory pressure (MIP) (IMT group, n\u2009=\u20098) or placebo training at 5% MIP (Sham group, n\u2009=\u20096), in a counter-balanced order, using an inspiratory threshold device for 4\xa0weeks', 'Inspiratory muscle training', 'inspiratory muscle training (IMT', 'IMT']","['MCAv, stroke volume, and cardiac output, as well as COP displacements', 'cerebrovascular and postural control responses', 'hemodynamic, cerebrovascular and postural balance responses', 'force plate to measure center-of-pressure (COP) oscillations (postural balance) and the electromyographic activity of the right medial gastrocnemius and tibialis anterior', 'blood pressure, heart rate, stroke volume, cardiac output, middle cerebral artery blood flow velocity (MCAv), and ventilation parameters']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",14.0,0.052373,"IMT improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress in older women.","[{'ForeName': 'Gabriel Dias', 'Initials': 'GD', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil.'}, {'ForeName': 'Jonas Lírio', 'Initials': 'JL', 'LastName': 'Gurgel', 'Affiliation': 'Department of Physical Education and Sports, Fluminense Federal University, Niteroi, Brazil.'}, {'ForeName': 'Iuri Dos Santos', 'Initials': 'IDS', 'LastName': 'Galdino', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil.'}, {'ForeName': 'Antonio Claudio Lucas', 'Initials': 'ACL', 'LastName': 'da Nóbrega', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil.'}, {'ForeName': 'Pedro Paulo da Silva', 'Initials': 'PPDS', 'LastName': 'Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil. ppssoares@id.uff.br.'}]",European journal of applied physiology,['10.1007/s00421-020-04441-2']
1627,32702079,Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial.,"Importance


Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear.
Objective


To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF.
Design, Setting, and Participants


This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019.
Interventions


Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter.
Main Outcomes and Measures


Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process.
Results


The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, -0.3 to 2.5 minutes).
Conclusion and Relevance


The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF.
Trial Registration


ClinicalTrials.gov Identifier: NCT02905032.",2020,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","['Patients With Atrial Fibrillation', 'mean [SD] age, 71 [11] years) and 244 clinicians', 'patients with atrial fibrillation (AF', '922 patients (559 men [60.6', 'A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication', 'patients with AF', '463 patients were randomized to the intervention arm and 459 patients to the standard care arm', 'patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019']",['standard care arm or care that included the use of an SDM tool (intervention arm'],"['Decision Making 12-item scale) scores', 'encounter duration', 'SDM quality and clinician satisfaction', 'Measures\n\n\nQuality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",922.0,0.0691682,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","[{'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kunneman', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Branda', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Hargraves', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Sivly', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lee', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Haeshik', 'Initials': 'H', 'LastName': 'Gorr', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Burnett', 'Affiliation': 'Thrombosis Clinic and Anticoagulation Services, Park Nicollet Health Services, St Louis Park, Minnesota.'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jackson', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linzer', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Brand-McCarthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2908']
1628,32717180,"Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study.","BACKGROUND


Diagnosis and treatment of colorectal peritoneal metastases at an early stage, before the onset of signs, could improve patient survival. We aimed to compare the survival benefit of systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC), with surveillance, in patients at high risk of developing colorectal peritoneal metastases.
METHODS


We did an open-label, randomised, phase 3 study in 23 hospitals in France. Eligible patients were aged 18-70 years and had a primary colorectal cancer with synchronous and localised colorectal peritoneal metastases removed during tumour resection, resected ovarian metastases, or a perforated tumour. Patients were randomly assigned (1:1) to surveillance or second-look surgery plus oxaliplatin-HIPEC (oxaliplatin 460 mg/m 2 , or oxaliplatin 300 mg/m 2  plus irinotecan 200 mg/m 2 , plus intravenous fluorouracil 400 mg/m 2 ), or mitomycin-HIPEC (mitomycin 35 mg/m 2 ) alone in case of neuropathy, after 6 months of adjuvant systemic chemotherapy with no signs of disease recurrence. Randomisation was done via a web-based system, with stratification by treatment centre, nodal status, and risk factors for colorectal peritoneal metastases. Second-look surgery consisted of a complete exploration of the abdominal cavity via xyphopubic incision, and resection of all peritoneal implants if resectable. Surveillance after resection of colorectal cancer was done according to the French Guidelines. The primary outcome was 3-year disease-free survival, defined as the time from randomisation to peritoneal or distant disease recurrence, or death from any cause, whichever occurred first, analysed by intention to treat. Surgical complications were assessed in the second-look surgery group only. This study was registered at ClinicalTrials.gov, NCT01226394.
FINDINGS


Between June 11, 2010, and March 31, 2015, 150 patients were recruited and randomly assigned to a treatment group (75 per group). After a median follow-up of 50·8 months (IQR 47·0-54·8), 3-year disease-free survival was 53% (95% CI 41-64) in the surveillance group versus 44% (33-56) in the second-look surgery group (hazard ratio 0·97, 95% CI 0·61-1·56). No treatment-related deaths were reported. 29 (41%) of 71 patients in the second-look surgery group had grade 3-4 complications. The most common grade 3-4 complications were intra-abdominal adverse events (haemorrhage, digestive leakage) in 12 (23%) of 71 patients and haematological adverse events in 13 (18%) of 71 patients.
INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance. Currently, essential surveillance of patients at high risk of developing colorectal peritoneal metastases appears to be adequate and effective in terms of survival outcomes.
FUNDING


French National Cancer Institute.",2020,"INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance.","['Between June 11, 2010, and March 31, 2015, 150 patients', 'Eligible patients were aged 18-70 years and had a primary colorectal cancer with synchronous and localised colorectal peritoneal metastases removed during tumour resection, resected ovarian metastases, or a perforated tumour', 'patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15', 'patients at high risk of developing colorectal peritoneal metastases', '23 hospitals in France']","['oxaliplatin-HIPEC', 'surveillance or second-look surgery plus oxaliplatin-HIPEC (oxaliplatin 460 mg/m 2 , or oxaliplatin 300 mg/m 2  plus irinotecan 200 mg/m 2 , plus intravenous fluorouracil 400 mg/m 2 ), or mitomycin-HIPEC (mitomycin 35 mg/m 2 ) alone in case of neuropathy, after 6 months of adjuvant systemic chemotherapy', 'Second-look surgery plus hyperthermic intraperitoneal chemotherapy', 'systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC']","['grade 3-4 complications', '3-year disease-free survival, defined as the time from randomisation to peritoneal or distant disease recurrence, or death from any cause, whichever occurred first, analysed by intention to treat', 'intra-abdominal adverse events (haemorrhage, digestive leakage', '3-year disease-free survival', 'disease-free survival', 'haematological adverse events', 'Surgical complications']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0022790', 'cui_str': 'Krukenberg tumor'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0949626', 'cui_str': 'Incision and reexploration for second look'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",150.0,0.506933,"INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance.","[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Goéré', 'Affiliation': 'Department of Surgical Oncology, University Hospital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France; Department of Surgical Oncology, University Hospital Gustave Roussy, Villejuif, France. Electronic address: diane.goere@aphp.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Glehen', 'Affiliation': 'Department of Surgical Oncology, University Hospital Lyon Sud, Pierre Bénite, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Quenet', 'Affiliation': 'Department of Surgical Oncology, Institut Régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guilloit', 'Affiliation': 'Department of Surgical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Bereder', 'Affiliation': 'Department of Surgical Oncology, University Hospital de Larchet, Nice, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Lorimier', 'Affiliation': 'Department of Surgical Oncology, Centre Paul Papin, Angers, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Thibaudeau', 'Affiliation': ""Department of Surgical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ghouti', 'Affiliation': 'Department of Surgical Oncology, University Hospital Purpan, Toulouse, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Department of Surgical Oncology, University Hospital Purpan, Toulouse, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Surgical Oncology, University Hospital Charles Nicolle, Rouen, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kianmanesh', 'Affiliation': 'Department of Surgical Oncology, University Hospital Robert Debré, Reims, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Carretier', 'Affiliation': 'Department of Surgical Oncology, University Hospital de Poitiers, Poitiers, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'Department of Surgical Oncology, Institut de Cancérologie de Lorraine, Nancy, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arvieux', 'Affiliation': 'Department of Visceral Surgery, University Hospital, Grenoble, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Surgical Oncology, University Hospital Hautepierre, Strasbourg, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meeus', 'Affiliation': 'Department of Surgical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rat', 'Affiliation': 'Department of Surgical Oncology, University Hospital du Bocage, Dijon, France.'}, {'ForeName': 'Sylvaine', 'Initials': 'S', 'LastName': 'Durand-Fontanier', 'Affiliation': 'Department of Surgical Oncology, University Hospital Dupuytren, Limoges, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Mariani', 'Affiliation': 'Department of Surgical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Lakkis', 'Affiliation': 'Department of Surgical Oncology, University Hospital Jean Minjoz, Besançon, France.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Loi', 'Affiliation': 'Department of Surgical Oncology, University Hospital Tenon, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pirro', 'Affiliation': 'Department of Surgical Oncology, University Hospital La Timone, Marseille, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Department of Surgical Oncology, University Hospital Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Texier', 'Affiliation': 'Department of Biostatistics, University Hospital Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Elias', 'Affiliation': 'Department of Surgical Oncology, University Hospital Gustave Roussy, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30322-3']
1629,32718922,"PROMISE (Program Refinements to Optimize Model Impact and Scalability based on Evidence): a cluster-randomised, stepped-wedge trial assessing effectiveness of the revised versus original Ryan White Part A HIV Care Coordination Programme for patients with barriers to treatment in the USA.","INTRODUCTION


Growing evidence supports combining social, behavioural and biomedical strategies to strengthen the HIV care continuum. However, combination interventions can be resource-intensive and challenging to scale up. Research is needed to identify intervention components and delivery models that maximise uptake, engagement and effectiveness. In New York City (NYC), a multicomponent Ryan White Part A-funded medical case management intervention called the Care Coordination Programme (CCP) was launched at 28 agencies in 2009 in order to address barriers to care and treatment. Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement.
METHODS AND ANALYSIS


Integrating evaluation findings and CCP service-provider and community-stakeholder input on modifications, the NYC Health Department packaged a Care Coordination Redesign (CCR) in a 2017 request for proposals. Following competitive re-solicitation, 17 of the original CCP-implementing agencies secured contracts. These agencies were randomised within matched pairs to immediate or delayed CCR implementation. Data from three 9-month periods (pre-implementation, partial implementation and full implementation) will be examined to compare CCR versus CCP effects on timely viral suppression (TVS, within 4 months of enrolment) among individuals with unsuppressed HIV viral load newly enrolling in the CCR/CCP. Based on current enrolment (n=933) and the pre-implementation outcome probability (TVS=0.54), the detectable effect size with 80% power is an OR of 2.75 (relative risk: 1.41).
ETHICS AND DISSEMINATION


This study was approved by the NYC Department of Health and Mental Hygiene Institutional Review Board (IRB, Protocol 18-009) and the City University of New York Integrated IRB (Protocol 018-0057) with a waiver of informed consent. Findings will be disseminated via publications, conferences, stakeholder meetings, and Advisory Board meetings with implementing agency representatives.
TRIAL REGISTRATION NUMBER


Registered with ClinicalTrials.gov under identifier: NCT03628287, V.2, 25 September 2019; pre-results.",2020,"Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement.
","['patients with barriers to treatment in the USA', 'individuals with unsuppressed HIV viral load newly enrolling in the CCR/CCP', 'NYC Department of Health and Mental Hygiene Institutional Review Board (IRB, Protocol 18-009) and the City University of New York Integrated IRB', ""7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement""]",['CCP service-provider and community-stakeholder input on modifications'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",[],7000.0,0.0888393,"Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement.
","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Irvine', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA mirvine@health.nyc.gov.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health (MSPH), Columbia University, New York, New York, USA.'}, {'ForeName': 'McKaylee M', 'Initials': 'MM', 'LastName': 'Robertson', 'Affiliation': 'Institute for Implementation Science in Population Health, Graduate School of Public Health and Health Policy, City University of New York, New York, New York, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Penrose', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Carmona', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Harriman', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Braunstein', 'Affiliation': 'Bureau of HIV, New York City Department of Health and Mental Hygiene, Queens, New York, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nash', 'Affiliation': 'Institute for Implementation Science in Population Health, Graduate School of Public Health and Health Policy, City University of New York, New York, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034624']
1630,32718924,Implementation of blood glucose self-monitoring among insulin-dependent patients with type 2 diabetes in three rural districts in Rwanda: 6 months open randomised controlled trial.,"INTRODUCTION


Most patients diagnosed with diabetes in sub-Saharan Africa (SSA) present with poorly controlled blood glucose, which is associated with increased risks of complications and greater financial burden on both the patients and health systems. Insulin-dependent patients with diabetes in SSA lack appropriate home-based monitoring technology to inform themselves and clinicians of the daily fluctuations in blood glucose. Without sufficient home-based data, insulin adjustments are not data driven and adopting individual behavioural change for glucose control in SSA does not have a systematic path towards improvement.
METHODS AND ANALYSIS


This study explores the feasibility and impact of implementing self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes in rural Rwandan districts. This is an open randomised controlled trial comprising of two arms: (1) Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up. We will conduct qualitative interviews at enrolment and at the end of the study to assess knowledge of diabetes. At the end of the study period, we will interview clinicians and participants to assess the perceived usefulness, facilitators and barriers of SMBG. The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG. Secondary outcomes include reliability and acceptability of SMBG and change in the quality of life of the participants.
ETHICS AND DISSEMINATION


This study has been approved by the Rwanda National Ethics Committee (Kigali, Rwanda No.102/RNEC/2018). We will disseminate the findings of this study through presentations within our study settings, scientific conferences and publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


PACTR201905538846394; pre-results.",2020,"The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG.","['dependent patients with type 2 diabetes in three rural districts in Rwanda', 'patients diagnosed with diabetes in sub-Saharan Africa (SSA', 'patients with type 2 diabetes in rural Rwandan districts']","['Intervention group-participants will receive a glucose metre, blood test strips, logbook, waste management box and training on how to conduct SMBG in additional to usual care and (2) Control group-participants will receive usual care, comprising of clinical consultations and routine monthly follow-up', 'blood glucose self-monitoring among insulin', 'implementing self-monitoring of blood glucose (SMBG']","['change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG', 'reliability and acceptability of SMBG and change in the quality of life of the participants']","[{'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0462899', 'cui_str': 'Blood testing strips'}, {'cui': 'C0242716', 'cui_str': 'Waste Management'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0961424,"The primary outcomes are change in haemoglobin A1c, fidelity to SMBG protocol by patients, appropriateness and adverse effects resulting from SMBG.","[{'ForeName': 'Loise', 'Initials': 'L', 'LastName': ""Ng'ang'a"", 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda loisehaks@gmail.com.'}, {'ForeName': 'Gedeon', 'Initials': 'G', 'LastName': 'Ngoga', 'Affiliation': 'Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Symaque', 'Initials': 'S', 'LastName': 'Dusabeyezu', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Bethany L', 'Initials': 'BL', 'LastName': 'Hedt-Gauthier', 'Affiliation': 'Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Patient', 'Initials': 'P', 'LastName': 'Ngamije', 'Affiliation': 'Kirehe District Hospital, Ministry of Health, Kigali, Rwanda.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Habiyaremye', 'Affiliation': 'Rwinkwavu District Hospital, Ministry of Health, Kigali, Rwanda.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Harerimana', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Ndayisaba', 'Affiliation': 'Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rusangwa', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Simon Pierre', 'Initials': 'SP', 'LastName': 'Niyonsenga', 'Affiliation': 'Non-Communicable Diseases Division, Rwanda Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Bavuma', 'Affiliation': 'Internal Medicine, University of Rwanda College of Medicine and Health Sciences, Kigali, Rwanda.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Bukhman', 'Affiliation': 'NCD Synergies, Partners in Health, Boston, Massachusetts, United States.'}, {'ForeName': 'Alma J', 'Initials': 'AJ', 'LastName': 'Adler', 'Affiliation': 'Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Kateera', 'Affiliation': 'Research, Inshuti Mu Buzima, Partners In Health-Rwanda, Rwinkwavu, Rwanda.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Park', 'Affiliation': 'NCD Synergies, Partners in Health, Boston, Massachusetts, United States.'}]",BMJ open,['10.1136/bmjopen-2019-036202']
1631,32732353,Identifying the preferable rheumatoid arthritis subgroups for intervention with the anti-RANKL antibody denosumab to reduce progression of joint destruction.,"OBJECTIVES


To clarify which rheumatoid arthritis (RA) patients benefit most from the anti-receptor activator of nuclear factor-κB ligand antibody denosumab to reduce the progression of joint destruction.
METHODS


We pooled patient data from the 12-month, double-blind, placebo-controlled DRIVE (phase II) and DESIRABLE (phase III) studies. In DRIVE, concomitant treatment was limited to methotrexate, salazosulfapyridine and bucillamine. In DESIRABLE, patients could receive any disease-modifying antirheumatic drug. RA patients were randomised to denosumab 60 mg every 6 months (Q6M), every 3 months (Q3M) or placebo. Efficacy was assessed by van der Heijde-modified total Sharp score (mTSS), bone erosion score (ES) and joint space narrowing score (JSNS). Change in mTSS was assessed in subgroups stratified by risk factors for radiographic damage if the interaction factor was significant.
RESULTS


The pooled analysis included 909 patients. Denosumab reduced worsening of mTSS (mean (SD)) at 12 months in the Q6M (0.88 (3.30), p=0.0024) and Q3M (0.66 (2.16), p=0.0002) groups versus placebo (1.50 (3.73)). This reduction in mTSS progression was due to the change in ES (Q6M, 0.44 (1.89), p=0.0006; Q3M, 0.20 (0.86), p<0.0001) versus placebo (0.98 (2.54)); no effect was observed on JSNS. Anti-cyclic citrullinated peptide (CCP) antibodies, glucocorticoid use and baseline ES showed a significant interaction. Denosumab was particularly effective in patients who were anti-CCP antibody positive (p<0.05). Changes in mTSS versus placebo were observed in all denosumab dose groups, regardless of glucocorticoid use and baseline ES.
CONCLUSIONS


Denosumab broadly reduced the progression of joint destruction in RA patients with risk factors for radiographic damage such as especially anti-CCP antibody positivity.",2020,Denosumab was particularly effective in patients who were anti-CCP antibody positive (p<0.05).,"['RA patients', 'patients could receive any disease-modifying antirheumatic drug', '909 patients']","['denosumab', 'methotrexate, salazosulfapyridine and bucillamine', 'Denosumab', 'placebo']","['worsening of mTSS (mean (SD', 'Change in mTSS', 'van der Heijde-modified total Sharp score (mTSS), bone erosion score (ES) and joint space narrowing score (JSNS', 'Efficacy', 'mTSS progression', 'Q3M', 'progression of joint destruction']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0073917', 'cui_str': 'bucillamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557775', 'cui_str': 'Van'}, {'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0541875', 'cui_str': 'Joint destruction'}]",909.0,0.178567,Denosumab was particularly effective in patients who were anti-CCP antibody positive (p<0.05).,"[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan tanaka@med.uoeh-u.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Department of Orthopaedic Surgery and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': 'Department of Orthopaedics, Nagoya University Graduate School of Medicine, Aichi, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Yamanaka', 'Affiliation': 'Director of Rheumatology, Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Clinical Development Department, Daiichi Sankyo Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Nitta', 'Affiliation': 'Clinical Development Department, Daiichi Sankyo Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Okubo', 'Affiliation': 'Data Intelligence Department, Daiichi Sankyo Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Genant', 'Affiliation': 'Departments of Radiology, University of California San Francisco, California, USA.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}]",RMD open,['10.1136/rmdopen-2020-001249']
1632,32735782,"Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial.","Background A substantial and unmet clinical need exists for pharmacological treatment of cannabis use disorders. Cannabidiol could offer a novel treatment, but it is unclear which doses might be efficacious or safe. Therefore, we aimed to identify efficacious doses and eliminate inefficacious doses in a phase 2a trial using an adaptive Bayesian design.
METHODS


We did a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial at the Clinical Psychopharmacology Unit (University College London, London, UK). We used an adaptive Bayesian dose-finding design to identify efficacious or inefficacious doses at a-priori interim and final analysis stages. Participants meeting cannabis use disorder criteria from DSM-5 were randomly assigned (1:1:1:1) in the first stage of the trial to 4-week treatment with three different doses of oral cannabidiol (200 mg, 400 mg, or 800 mg) or with matched placebo during a cessation attempt by use of a double-blinded block randomisation sequence. All participants received a brief psychological intervention of motivational interviewing. For the second stage of the trial, new participants were randomly assigned to placebo or doses deemed efficacious in the interim analysis. The primary objective was to identify the most efficacious dose of cannabidiol for reducing cannabis use. The primary endpoints were lower urinary 11-nor-9-carboxy-δ-9-tetrahydrocannabinol (THC-COOH):creatinine ratio, increased days per week with abstinence from cannabis during treatment, or both, evidenced by posterior probabilities that cannabidiol is better than placebo exceeding 0·9. All analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov (NCT02044809) and the EU Clinical Trials Register (2013-000361-36).
FINDINGS


Between May 28, 2014, and Aug 12, 2015 (first stage), 48 participants were randomly assigned to placebo (n=12) and to cannabidiol 200 mg (n=12), 400 mg (n=12), and 800 mg (n=12). At interim analysis, cannabidiol 200 mg was eliminated from the trial as an inefficacious dose. Between May 24, 2016, and Jan 12, 2017 (second stage), randomisation continued and an additional 34 participants were allocated (1:1:1) to cannabidiol 400 mg (n=12), cannabidiol 800 mg (n=11), and placebo (n=11). At final analysis, cannabidiol 400 mg and 800 mg exceeded primary endpoint criteria (0·9) for both primary outcomes. For urinary THC-COOH:creatinine ratio, the probability of being the most efficacious dose compared with placebo given the observed data was 0·9995 for cannabidiol 400 mg and 0·9965 for cannabidiol 800 mg. For days with abstinence from cannabis, the probability of being the most efficacious dose compared with placebo given the observed data was 0·9966 for cannabidiol 400 mg and 0·9247 for cannabidiol 800 mg. Compared with placebo, cannabidiol 400 mg decreased THC-COOH:creatinine ratio by -94·21 ng/mL (95% interval estimate -161·83 to -35·56) and increased abstinence from cannabis by 0·48 days per week (0·15 to 0·82). Compared with placebo, cannabidiol 800 mg decreased THC-COOH:creatinine ratio by -72·02 ng/mL (-135·47 to -19·52) and increased abstinence from cannabis by 0·27 days per week (-0·09 to 0·64). Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
INTERPRETATION


In the first randomised clinical trial of cannabidiol for cannabis use disorder, cannabidiol 400 mg and 800 mg were safe and more efficacious than placebo at reducing cannabis use.
FUNDING


Medical Research Council.",2020,"Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
","['48 participants', 'Participants meeting cannabis use disorder criteria from DSM-5', 'Between May 28, 2014, and Aug 12, 2015 (first stage']","['placebo', 'oral cannabidiol', 'placebo, cannabidiol', 'brief psychological intervention of motivational interviewing', 'cannabidiol 400 mg (n=12), cannabidiol 800 mg (n=11), and placebo']","['THC-COOH:creatinine ratio', 'lower urinary 11-nor-9-carboxy-δ-9-tetrahydrocannabinol (THC-COOH):creatinine ratio']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",48.0,0.767603,"Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
","[{'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Freeman', 'Affiliation': ""Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK; Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Electronic address: t.p.freeman@bath.ac.uk.""}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Hindocha', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Baio', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Natacha D C', 'Initials': 'NDC', 'LastName': 'Shaban', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Thomas', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Astbury', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Freeman', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lees', 'Affiliation': 'Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': ""Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK; National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Morrison', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael A P', 'Initials': 'MAP', 'LastName': 'Bloomfield', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK; The Traumatic Stress Clinic, St Pancras Hospital, Camden and Islington National Health Service Foundation Trust, London, UK; Pain Management Centre, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': ""O'Ryan"", 'Affiliation': 'Substance Misuse Services, Camden and Islington National Health Service Foundation Trust, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kinghorn', 'Affiliation': 'Translational Research Office, School of Life and Medical Sciences, University College London, London, UK.'}, {'ForeName': 'Celia J A', 'Initials': 'CJA', 'LastName': 'Morgan', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mofeez', 'Affiliation': 'Pain Management Centre, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30290-X']
1633,32704386,"Erratum: Author Correction: Antibody responses to the RTS,S/AS01 E  vaccine and  Plasmodium falciparum  antigens after a booster dose within the phase 3 trial in Mozambique.",[This corrects the article DOI: 10.1038/s41541-020-0192-7.].,2020,[This corrects the article DOI: 10.1038/s41541-020-0192-7.].,['Erratum'],[],[],[],[],[],,0.0161305,[This corrects the article DOI: 10.1038/s41541-020-0192-7.].,"[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Sánchez', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Chenjerai', 'Initials': 'C', 'LastName': 'Jairoce', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Aguilar', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Ubillos', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Inocencia', 'Initials': 'I', 'LastName': 'Cuamba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Augusto J', 'Initials': 'AJ', 'LastName': 'Nhabomba', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Nana Aba', 'Initials': 'NA', 'LastName': 'Williams', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Díez-Padrisa', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cavanagh', 'Affiliation': ""Institute of Immunology & Infection Research and Centre for Immunity, Infection & Evolution, Ashworth Laboratories, School of Biological Sciences, University of Edinburgh, King's Buildings, Edinburgh, UK.""}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Angov', 'Affiliation': 'U.S. Military Malaria Vaccine Program, Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD USA.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Coppel', 'Affiliation': 'Infection and Immunity Program, Monash Biomedicine Discovery Institute and Department of Microbiology, Monash University, Melbourne, VIC Australia.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Gaur', 'Affiliation': 'Malaria Group, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, India.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Melbourne, VIC Australia.'}, {'ForeName': 'Sheetij', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'U.S. Military Malaria Vaccine Program, Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Aide', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Campo', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Catalonia Spain.'}]",NPJ vaccines,['10.1038/s41541-020-00213-3']
1634,32701954,Effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among UK adolescents: A cluster randomised controlled trial.,"BACKGROUND


Less than 20% of adolescents globally meet recommended levels of physical activity, and not meeting these recommended levels is associated with social disadvantage and rising disease risk. The determinants of physical activity in adolescents are multilevel and poorly understood, but the school's social environment likely plays an important role. We conducted a cluster randomised controlled trial to assess the effectiveness of a school-based programme (GoActive) to increase moderate-to-vigorous physical activity (MVPA) among adolescents.
METHODS AND FINDINGS


Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion. Within participating schools (n = 16), all Year 9 students were eligible and invited to participate. Participants were 2,862 13- to 14-year-olds (84% of eligible students). After baseline assessment, schools were computer-randomised, stratified by school-level pupil premium funding (below/above county-specific median) and county (control: 8 schools, 1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43]). Measurement staff were blinded to allocation. The iteratively developed, feasibility-tested 12-week intervention, aligned with self-determination theory, trained older adolescent mentors and in-class peer-leaders to encourage classes to conduct 2 new weekly activities. Students and classes gained points and rewards for engaging in any activity in or out of school. The primary outcome was average daily minutes of accelerometer-assessed MVPA at 10-month follow-up; a mixed-methods process evaluation evaluated implementation. Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5%). At 10 months, there was a mean (SD) decrease in MVPA of 8.3 (19.3) minutes in the control group and 10.4 (22.7) minutes in the intervention group (baseline-adjusted difference [95% confidence interval] -1.91 minutes [-5.53 to 1.70], p = 0.316). The programme cost £13 per student compared with control; it was not cost-effective. Overall, 62.9% of students and 87.3% of mentors reported that GoActive was fun. Teachers and mentors commented that their roles in programme delivery were unclear. Implementation fidelity was low. The main methodological limitation of this study was the relatively affluent and ethnically homogeneous sample.
CONCLUSIONS


In this study, we observed that a rigorously developed school-based intervention was no more effective than standard school practice at preventing declines in adolescent physical activity. Interdisciplinary research is required to understand educational-setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN31583496.",2020,The programme cost £13 per student compared with control; it was not cost-effective.,"['1,319 participants, mean [SD] participants per school n = 165 [62]; intervention: 8 schools, 1,543 participants, n = 193 [43', 'Non-fee-paying, co-educational schools including Year 9 students in the UK counties of Cambridgeshire and Essex were eligible for inclusion', 'Of 2,862 recruited participants (52.1% male), 2,167 (76%) attended 10-month follow-up measurements; we analysed the primary outcome for 1,874 participants (65.5', 'Within participating schools (n = 16), all Year 9 students were eligible and invited to participate', 'UK adolescents', 'Participants were 2,862 13- to 14-year-olds (84% of eligible students', 'adolescents']","['school-based programme (GoActive', 'GoActive intervention']","['average daily minutes of accelerometer-assessed MVPA', 'physical activity', 'Effectiveness and cost-effectiveness', 'moderate-to-vigorous physical activity (MVPA', 'mean (SD) decrease in MVPA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0454843', 'cui_str': 'Cambridgeshire'}, {'cui': 'C0454853', 'cui_str': 'Essex'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",2862.0,0.114617,The programme cost £13 per student compared with control; it was not cost-effective.,"[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Corder', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Jong', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Foubister', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Helen Elizabeth', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Wells', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Sofie M', 'Initials': 'SM', 'LastName': 'Armitage', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Caroline H D', 'Initials': 'CHD', 'LastName': 'Croxson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vignoles', 'Affiliation': 'Faculty of Education, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': 'UKCRC Centre for Diet and Activity Research, University of Cambridge, Cambridge, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003210']
1635,32709643,Is a definitive trial of prehospital continuous positive airway pressure versus standard oxygen therapy for acute respiratory failure indicated? The ACUTE pilot randomised controlled trial.,"OBJECTIVES


To determine the feasibility of a large-scale definitive multicentre trial of prehospital continuous positive airway pressure (CPAP) in acute respiratory failure.
DESIGN


A single-centre, open-label, individual patient randomised, controlled, external pilot trial.
SETTING


A single UK Ambulance Service, between August 2017 and July 2018.
PARTICIPANTS


Adults with respiratory distress and peripheral oxygen saturations below British Thoracic Society target levels despite controlled oxygen treatment.
INTERVENTIONS


Patients were randomised to prehospital CPAP (O-Two system) versus standard oxygen therapy in a 1:1 ratio using simple randomisation.
PRIMARY AND SECONDARY OUTCOME MEASURES


Feasibility outcomes comprised recruitment rate, adherence to allocated treatment, retention and data completeness. The primary clinical outcome was 30-day mortality.
RESULTS


77 patients were enrolled (target 120), including 7 cases with a diagnosis where CPAP could be ineffective or harmful. CPAP was fully delivered in 74% (target 75%). There were no major protocol violations. Full data were available for all key outcomes (targets ≥90%). Overall 30-day mortality was 27.3%. Of these deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions implemented excluding hospital non-invasive ventilation and critical care.
CONCLUSIONS


Recruitment rate was below target and feasibility was not demonstrated. Limited compliance with CPAP, and difficulty in identifying patients who could benefit from CPAP, indicate that prehospital CPAP is unlikely to materially reduce mortality. A definitive effectiveness trial of CPAP is therefore not recommended.
TRIAL REGISTRATION NUMBER


ISRCTN12048261; Post-results.",2020,There were no major protocol violations.,"['77 patients were enrolled (target 120), including 7 cases with a diagnosis where CPAP could be ineffective or harmful', 'Adults with respiratory distress and peripheral oxygen saturations below British Thoracic Society target levels despite controlled oxygen treatment', 'A single UK Ambulance Service, between August 2017 and July 2018', 'Of these deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions implemented excluding hospital non-invasive ventilation and critical care']","['prehospital CPAP (O-Two system) versus standard oxygen therapy', 'CPAP', 'prehospital continuous positive airway pressure versus standard oxygen therapy', 'prehospital continuous positive airway pressure (CPAP']","['30-day mortality', 'recruitment rate, adherence to allocated treatment, retention and data completeness', 'CPAP', 'Overall 30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",77.0,0.313875,There were no major protocol violations.,"[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fuller', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK g.fuller@sheffield.ac.uk.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Keating', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Goodacre', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Herbert', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Perkins', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Rosser', 'Affiliation': 'West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill, West Midlands, UK.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Gunson', 'Affiliation': 'West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill, West Midlands, UK.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill, West Midlands, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'West Midlands Ambulance Service NHS Foundation Trust, Brierley Hill, West Midlands, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Bradburn', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Thokala', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'School of Medicine and Dentistry, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Marsh', 'Affiliation': 'Sheffield Emergency Care Forum, Sheffield, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035915']
1636,32707289,Effect of an abdominal hypopressive technique programme on pelvic floor muscle tone and urinary incontinence in women: a randomised crossover trial.,"OBJECTIVES


To test the effect of a structured abdominal hypopressive technique (AHT) programme on pelvic floor muscle (PFM) tone and urinary incontinence (UI) in women.
DESIGN


Crossover trial with random assignment of women to one of two groups: Group 1 (AHT followed by rest) and Group 2 (rest followed by AHT).
SETTING


Two cultural centres in Madrid, Spain.
PARTICIPANTS


Women aged 20-65 years.
INTERVENTIONS


Two months of supervised AHT exercises compared with 2 months of rest.
MAIN OUTCOME MEASURES


Variation in PFM tone and score on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)].
RESULTS


Forty-two women were randomised to two groups (both n=21). No sequence or period effect was noted. The mean difference in PFM tone after the 2-month AHT programme was 59g/cm² [95% confidence interval (CI) 37 to 82]; the between-group difference was 83g/cm² (95% CI 50 to 116; P<0.001). After 2 months, the between-group difference in the ICIQ-SF score was 3.3 points (P<0.001). The majority of participants reported improved body image and sense of well-being.
CONCLUSIONS


A structured 2-month AHT programme for women showed short-term benefits in PFM tone and UI. In addition, study participants reported improved body image and sense of well-being, and programme satisfaction, as demonstrated by questionnaire at the end of the intervention period. Further research is needed to test the long-term effects and effectiveness of AHT compared with other PFM exercises. ClinicalTrials.gov Identifier NCT0221241.",2020,"After 2 months, the between-group difference in the ICIQ-SF score was 3.3 points (P<0.001).","['women', 'women to one of two groups', 'Forty-two women', 'Two cultural centres in Madrid, Spain', 'Women aged 20-65 years']","['Group 1 (AHT followed by rest) and Group 2 (rest followed by AHT', 'structured abdominal hypopressive technique (AHT) programme', 'supervised AHT exercises', 'AHT', 'abdominal hypopressive technique programme']","['pelvic floor muscle tone and urinary incontinence', 'ICIQ-SF score', 'PFM tone', 'pelvic floor muscle (PFM) tone and urinary incontinence (UI', 'body image and sense of well-being, and programme satisfaction', 'Variation in PFM tone and score on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF', 'body image and sense of well-being']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}]",42.0,0.187985,"After 2 months, the between-group difference in the ICIQ-SF score was 3.3 points (P<0.001).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Soriano', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'González-Millán', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Álvarez Sáez', 'Affiliation': 'Maio Medical Centre, Vigo, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Curbelo', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain; Instituto de Salud Musculoesquelética, Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Carmona', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain; Instituto de Salud Musculoesquelética, Madrid, Spain. Electronic address: loreto.carmona@inmusc.eu.'}]",Physiotherapy,['10.1016/j.physio.2020.02.004']
1637,32707332,An invited commentary: The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,,2020,,['renal transplantation'],['transversus abdominis plane block with or without dexmedetomidine'],[],"[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.168804,,"[{'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: yulang5301@sina.com.'}, {'ForeName': 'Taowu', 'Initials': 'T', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: chenmingaini1232@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.008']
1638,32715442,"Variation in the UGT2B17 genotype, exemestane metabolism and menopause-related toxicities in the CCTG MAP.3 trial.","PURPOSE


To examine associations between the UGT2B17 gene deletion and exemestane metabolites, and commonly reported side effects (fatigue, hot flashes, and joint pain) among postmenopausal women participating in the MAP.3 chemoprevention trial.
METHODS


The analytical samples for the UGT2B17 analysis comprised 1752 women on exemestane and 1721 women on placebo; the exemestane metabolite analysis included 1360 women on exemestane with one-year serum samples. Both the UGT2B17 gene deletion and metabolites were measured in blood. The metabolites were conceptualized as a ratio (17-DHE-Gluc:17-DHE). Symptoms were assessed using the CTCAE v4.0 at approximately 1-year intervals. Log-binomial regression was used to examine the associations between UGT2B17 deletion, exemestane metabolites and each side effect at 1 and up to 5-year follow-up, adjusting for potential confounders.
RESULTS


Among individuals on exemestane with the UGT2B17 gene deletion (i.e., lower detoxification), a higher risk of severe fatigue (RR = 2.59 95% CI: 1.14-5.89) was observed at up to 5-year follow-up. Among individuals on placebo, those with the UGT2B17 gene deletion had a higher risk of any fatigue (RR = 1.39, 95% CI: 1.02-1.89) at year 1. A lower metabolite ratio (poor detoxification) was associated with a higher risk of any fatigue, hot flashes and joint pain at year 1 (fatigue: RR = 1.89, 95% CI: 1.16-3.09; hot flashes: RR = 1.77, 95% CI: 1.40-2.24; joint pain: RR = 2.05, 95% CI: 1.35-3.12); similar associations were observed at 5-year follow-up.
CONCLUSION


Variation in the metabolism of exemestane through the UGT2B17-mediated pathway is associated with subsequent risk of commonly reported symptoms in MAP.3.",2020,"A lower metabolite ratio (poor detoxification) was associated with a higher risk of any fatigue, hot flashes and joint pain at year 1 (fatigue: RR = 1.89, 95% CI: 1.16-3.09; hot flashes: RR = 1.77, 95% CI: 1.40-2.24; joint pain: RR = 2.05, 95% CI: 1.35-3.12); similar associations were observed at 5-year follow-up.
","['analysis included 1360 women on exemestane with one-year serum samples', '1752 women on exemestane and 1721 women on', 'postmenopausal women participating in the MAP.3 chemoprevention trial']","['exemestane', 'exemestane metabolite', 'placebo']","['higher risk of any fatigue, hot flashes and joint pain', 'severe fatigue', 'higher risk of any fatigue', 'side effects (fatigue, hot flashes, and joint pain', 'metabolite ratio (poor detoxification']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}]",1752.0,0.292134,"A lower metabolite ratio (poor detoxification) was associated with a higher risk of any fatigue, hot flashes and joint pain at year 1 (fatigue: RR = 1.89, 95% CI: 1.16-3.09; hot flashes: RR = 1.77, 95% CI: 1.40-2.24; joint pain: RR = 2.05, 95% CI: 1.35-3.12); similar associations were observed at 5-year follow-up.
","[{'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Ho', 'Affiliation': 'Department of Social and Preventive Medicine, University of Montreal, 850 rue Saint-Denis, Tour Saint-Antoine, 3rd Floor, S03.412, Montréal, QC, H2X0A9, Canada.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pasquet', 'Affiliation': 'Department of Social and Preventive Medicine, University of Montreal, 850 rue Saint-Denis, Tour Saint-Antoine, 3rd Floor, S03.412, Montréal, QC, H2X0A9, Canada.'}, {'ForeName': 'Shaman', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, 412 E. Spokane Falls Blvd., PBS 431, Spokane, WA, 99202-2131, USA.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, 412 E. Spokane Falls Blvd., PBS 431, Spokane, WA, 99202-2131, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goss', 'Affiliation': 'Harvard Medical School, MGH Cancer Center, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Division Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L 3N6, Canada.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lazarus', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, 412 E. Spokane Falls Blvd., PBS 431, Spokane, WA, 99202-2131, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Richardson', 'Affiliation': ""Divisions of Canadian Cancer Trials Group and Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, 10 Stuart Street, Room 220, Kingston, ON, K7L 3N6, Canada. hrichardson@ctg.queensu.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-020-05812-1']
1639,32717350,A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction.,"College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive intervention (API) to reduce high-risk drinking among first-year college students. The API is designed to educate students and to motivate heavy-drinking college students to engage in existing resources to support reducing high-risk alcohol use, by leveraging technology-based intervention modalities. The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization. Adaptive preventive interventions have the potential to reduce the acute and long-term negative health consequences of young adult alcohol use.",2020,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","['college student drinking reduction', 'first-year college students']",['adaptive preventive intervention (API'],"['reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization']","[{'cui': 'C4042862', 'cui_str': 'Alcohol Drinking, College Students'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",,0.0187936,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Boatman', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Morrell', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Wagner', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Grace R', 'Initials': 'GR', 'LastName': 'Lyden', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, 2800 Plymouth Road, NCRC Building 10, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Vock', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106089']
1640,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
1641,32717627,Does a Facebook-enhanced Mindful Self-Compassion intervention improve body image? An evaluation study.,"This study evaluates a brief intervention aimed at improving body image. The intervention comprised a Mindful Self-Compassion workshop complemented by a group discussion on Facebook. Young women (M age  = 18.31), screened for body concerns, were allocated by university campus to a 50-minute workshop intervention (n = 42) or a waitlist control (n = 34). Following the workshop, participants in the intervention group utilized self-compassion techniques when experiencing appearance distress and posted about their experiences on a private Facebook group three times per week for two weeks. Findings showed that, relative to control, the intervention group experienced lower upward appearance comparison, social appearance anxiety, body dissatisfaction, and drive for thinness, and higher body appreciation and self-compassion, at posttest and 1-month follow-up. All effects, except those for body dissatisfaction, were held at 3-month follow-up. Additionally, common humanity predicted gains in body appreciation from pretest to posttest. The Mindful Self-Compassion intervention involving a Facebook group may have resonated with young women as it allowed them to share moments of self-compassionate body image experiences in a private and supportive environment.",2020,"Findings showed that, relative to control, the intervention group experienced lower upward appearance comparison, social appearance anxiety, body dissatisfaction, and drive for thinness, and higher body appreciation and self-compassion, at posttest and 1-month follow-up.","['Young women (M age  = 18.31), screened for body concerns, were allocated by university campus to a']","['Facebook-enhanced Mindful Self-Compassion intervention', 'Mindful Self-Compassion workshop complemented by a group discussion on Facebook', '50-minute workshop intervention', 'waitlist control']","['lower upward appearance comparison, social appearance anxiety, body dissatisfaction, and drive for thinness, and higher body appreciation and self-compassion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1282911', 'cui_str': 'Upward'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0039870', 'cui_str': 'Thin build'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",,0.0146737,"Findings showed that, relative to control, the intervention group experienced lower upward appearance comparison, social appearance anxiety, body dissatisfaction, and drive for thinness, and higher body appreciation and self-compassion, at posttest and 1-month follow-up.","[{'ForeName': 'Veya', 'Initials': 'V', 'LastName': 'Seekis', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia. Electronic address: v.seekis@griffith.edu.au.'}, {'ForeName': 'Graham L', 'Initials': 'GL', 'LastName': 'Bradley', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia. Electronic address: g.bradley@griffith.edu.au.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Duffy', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia. Electronic address: a.duffy@griffith.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.006']
1642,32719129,Randomized trial shows healthcare payment reform has equal-sized spillover effects on patients not targeted by reform.,"Changes in the way health insurers pay healthcare providers may not only directly affect the insurer's patients but may also affect patients covered by other insurers. We provide evidence of such spillovers in the context of a nationwide Medicare bundled payment reform that was implemented in some areas of the country but not in others, via random assignment. We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients. We discuss the implications of these findings for estimates of the impact of healthcare payment reforms and more generally for the design of healthcare policy.",2020,"We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients.",[],[],[],[],[],[],,0.0338305,"We estimate that the payment reform-which targeted traditional Medicare patients-had effects of similar magnitude on the healthcare experience of nontargeted, privately insured Medicare Advantage patients.","[{'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Einav', 'Affiliation': 'Department of Economics, Stanford University, Stanford, CA 94305.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Finkelstein', 'Affiliation': 'National Bureau of Economic Research, Cambridge, MA 02138; afink@mit.edu.'}, {'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Graduate School of Arts and Sciences, Harvard University, Cambridge, MA 02138.'}, {'ForeName': 'Neale', 'Initials': 'N', 'LastName': 'Mahoney', 'Affiliation': 'Department of Economics, Stanford University, Stanford, CA 94305.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2004759117']
1643,32719133,Objecting to experiments even while approving of the policies or treatments they compare.,"We resolve a controversy over two competing hypotheses about why people object to randomized experiments: 1) People unsurprisingly object to experiments only when they object to a policy or treatment the experiment contains, or 2) people can paradoxically object to experiments even when they approve of implementing either condition for everyone. Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.",2020,"Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.","['five preregistered within-subjects studies with 1,955 participants']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],,0.0207082,"Using multiple measures of preference and test criteria in five preregistered within-subjects studies with 1,955 participants, we find that people often disapprove of experiments involving randomization despite approving of the policies or treatments to be tested.","[{'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Heck', 'Affiliation': 'Center for Translational Bioethics and Health Care Policy, Geisinger Health System, Danville, PA 17822; pheck1000@gmail.com.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Chabris', 'Affiliation': 'Autism and Developmental Medicine Institute, Geisinger Health System, Lewisburg, PA 17837.'}, {'ForeName': 'Duncan J', 'Initials': 'DJ', 'LastName': 'Watts', 'Affiliation': 'Annenberg School for Communication, University of Pennsylvania, Philadelphia, PA 19104.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Meyer', 'Affiliation': 'Center for Translational Bioethics and Health Care Policy, Geisinger Health System, Danville, PA 17822.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2009030117']
1644,32719151,'Should we stop or continue conventional synthetic (including glucocorticoids) and targeted DMARDs before surgery in patients with inflammatory rheumatic diseases?',"Total hip and total knee arthroplasty) remain important interventions to treat symptomatic knee and hip damage in patients with rheumatoid arthritis, with little change in utilisation rates despite the increasingly widespread use of potent conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and targeted DMARDs including Janus kinase inhibitors and biologics. The majority of patients are receiving these immunosuppressing medications and glucocorticoids at the time they present for arthroplasty. There is minimal randomised controlled trial data addressing the use of DMARDs in the perioperative period, yet patients and their physicians face these decisions daily. This paper reviews what is known regarding perioperative management of targeted and csDMARDs and glucocorticoids.",2020,"Total hip and total knee arthroplasty) remain important interventions to treat symptomatic knee and hip damage in patients with rheumatoid arthritis, with little change in utilisation rates despite the increasingly widespread use of potent conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and targeted DMARDs including Janus kinase inhibitors and biologics.","['patients with rheumatoid arthritis', 'patients with inflammatory rheumatic diseases', 'Total hip and total knee arthroplasty']",['conventional synthetic (including glucocorticoids) and targeted DMARDs before surgery'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",[],,0.0359957,"Total hip and total knee arthroplasty) remain important interventions to treat symptomatic knee and hip damage in patients with rheumatoid arthritis, with little change in utilisation rates despite the increasingly widespread use of potent conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and targeted DMARDs including Janus kinase inhibitors and biologics.","[{'ForeName': 'Susan M', 'Initials': 'S M', 'LastName': 'Goodman', 'Affiliation': 'Department of Medicine, Hospital for Special Surgery, Weill Cornell Medicine, New York, USA Goodmans@hss.edu.'}, {'ForeName': 'Michael D', 'Initials': 'M D', 'LastName': 'George', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",RMD open,['10.1136/rmdopen-2020-001214']
1645,32726041,[Randomized double-blind parallel controlled multicenter trial of Reyanning Mixture in treatment of acute tonsillitis].,"This study is a randomized controlled trial of Reyanning Mixture in the treatment of acute tonsillitis. According to the ratio of 1∶1∶1, a total of 144 patients were randomly divided into Reyanning Mixture group(RYN), Reyanning Mixture+Amoxicillin Capsules group(RYN+Amoxil) and Amoxicillin Capsules group(Amoxil), with 48 cases in each group, in order to evaluate the efficacy and safety of RYN alone or combined with Amoxil in the treatment of acute tonsillitis, and provided high-quality evidences for treatment of infectious diseases with traditional Chinese medicine and reduced use of antibiotics. The dosage of RYN was 20 mL, 3 times a day, 100 mL/bottle, oral for 7 days, and Amoxil dosage was 0.5 g, 3 times a day, 0.5 g×12 tablets/plate, oral for 7 days. A total of 144 cases were included, 3 cases were excluded(1 case was mistakenly included, 2 cases did not take drugs after inclu-ded), and a total of 141 cases were included in the full analysis set(FAS). The results showed statistical differences in the recovery time of the disease, the disappearance rate of fever on the 3 rd day and the disappearance rate of tonsillar redness and swelling between RYN and Amoxil. There were statistical differences in the cure rate of disease, recovery time of disease, body temperature recovery time, fever disappearance rate on the 3 rd day, pharynx swelling and pain disappearance rate and tonsil swelling disappearance rate between the RYN+Amoxil and Amoxil, but with no significant difference in the above aspects compared with RYN. The DDD of antibiotic use in RYN+Amoxil was significantly lower than that in Amoxil(P&lt;0.01). According to the findings, when RYN was used alone in the treatment of acute tonsillitis, it was superior to Amoxil in time of recovery, short-term improvement of fever and redness and swelling of tonsil. Compared with RYN+Amoxil, there was no difference in cure rate of disease, recovery time of disease, body temperature recovery time, short-term improvement of fever, swelling of pharynx and swelling of tonsil, with a better efficacy than Amoxil. The clinical effect of RYN was similar to that of combined Amoxil in the treatment of acute tonsillitis, and RYN was superior to Amoxil in the time of recovery, short-term improvement of fever and redness and swelling of tonsil, with no adverse event or adverse reaction. RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.",2020,"RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.","['A total of 144 cases were included, 3 cases were excluded(1 case was mistakenly included, 2 cases did not take drugs after inclu-ded), and a total of 141 cases were included in the full analysis set(FAS', 'acute tonsillitis', '144 patients']","['RYN alone or combined with Amoxil', 'RYN+Amoxil', 'Reyanning Mixture', 'Reyanning Mixture+Amoxicillin Capsules group(RYN+Amoxil) and Amoxicillin Capsules group(Amoxil']","['disappearance rate of tonsillar redness and swelling between RYN and Amoxil', 'fever and redness and swelling of tonsil', 'DDD value of antibiotics', 'efficacy and safety', 'recovery time of the disease, the disappearance rate of fever', 'cure rate of disease, recovery time of disease, body temperature recovery time, fever disappearance rate on the 3 rd day, pharynx swelling and pain disappearance rate and tonsil swelling disappearance rate', 'fever and redness and swelling of tonsil, with no adverse event or adverse reaction', 'DDD of antibiotic use in RYN+Amoxil', 'cure rate of disease, recovery time of disease, body temperature recovery time, short-term improvement of fever, swelling of pharynx and swelling of tonsil']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0001361', 'cui_str': 'Acute tonsillitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0040421', 'cui_str': 'Tonsillar structure (palatine)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0011037', 'cui_str': 'DDD'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549123', 'cui_str': 'Large tonsils'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",144.0,0.0560318,"RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Beijing First Integrated Traditional Chinese and Western Medicine Hospital Beijing 100021, China.'}, {'ForeName': 'Lian-Xin', 'Initials': 'LX', 'LastName': 'Wang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Xie', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Xue-Qing', 'Initials': 'XQ', 'LastName': 'Yu', 'Affiliation': 'the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450004, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Beijing Chaoyang Hospital, Capital Medical University Beijing 100043, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Wangjing Hospital, China Academy of Chinese Medical Sciences Beijing 100102, China.'}, {'ForeName': 'Jing-Xiao', 'Initials': 'JX', 'LastName': 'Zhang', 'Affiliation': 'School of Statistics, Renmin University of China Beijing 100872, China.'}, {'ForeName': 'Xiao-Kang', 'Initials': 'XK', 'LastName': 'Yu', 'Affiliation': 'School of Statistics, Renmin University of China Beijing 100872, China.'}]",Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,['10.19540/j.cnki.cjcmm.20200420.501']
1646,32721578,The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods.,"BACKGROUND


Data addressing air quality effects on children with asthma in rural U.S. communities are rare. Our community engaged research partnership previously demonstrated associations between neighborhood NH 3  and ambient PM 2.5  and asthma in the agricultural lower Yakima Valley of Washington. As a next step, the partnership desired an intervention approach to address concerns about pediatric asthma in this largely Latino immigrant, farm worker community.
OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  We investigated the effect of this enriched approach on these exposures and asthma health measures.
DESIGN


We randomized children with poorly controlled asthma to a control arm (current asthma education program) or an intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home). Outcomes included (1) 14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics at baseline, midpoint (4-6 months) and one-year follow-up. These included the Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration.
DISCUSSION


To our knowledge, this is the first randomized HEPA cleaner intervention designed to assess NH 3  as well as PM 2.5  and to evaluate health outcomes of children with asthma in an agricultural region.",2020,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","['children with asthma in rural U.S. communities', 'children with asthma in an agricultural region', 'children with poorly controlled asthma to a control arm (current asthma education program) or an']","[""intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home""]","['14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics', 'Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337099', 'cui_str': 'Air contaminant'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4704932', 'cui_str': 'Health Metrics'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0221442,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Masterson', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America. Electronic address: emaster@uw.edu.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Younglove', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': ""Yakima Valley Farm Worker's Clinic, Toppenish, WA, United States of America.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Torres', 'Affiliation': 'Northwest Communities Education Center, Radio KDNA, Granger, WA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Krenz', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tchong French', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Riederer', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sampson', 'Affiliation': 'Department of Statistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Nervana', 'Initials': 'N', 'LastName': 'Metwali', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Min', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Aisenberg', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Babadi', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Farquhar', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Health Services, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Karr', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Pediatrics, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106085']
1647,32721815,Effect of intranasal oxytocin administration on self-other distinction: Modulations by psychological distance and gender.,"Preliminary evidence indicates that intranasal oxytocin (OT) administration modulates one's ability to distinguish oneself from others (i.e., self-other distinction). However, previous findings on this topic are contradictory. The current study addressed this issue by (i) using a novel perceptual matching task examining self-other distinction compared to both close and distant others, and (ii) tentatively exploring potential modulations by gender. In a double-blind, placebo-controlled, randomized OT administration study, 100 participants (50 males and 50 females) were randomized to receive intranasal spray of 24 IU OT or placebo (PL). Afterwards, participants completed a geometry perceptual matching task in which different shapes were paired to the self, a friend, or a stranger. Participants were then asked to judge whether each pair of shapes and labels was correctly matched. The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females. These findings provide insights for debates on the role of OT in self-other distinction by revealing modulations by psychological distance and gender, which have implications for the potential clinical applications of OT.",2020,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.",['100 participants (50 males and 50 females'],"['intranasal spray of 24 IU OT or placebo (PL', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],100.0,0.104773,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, China; School of Psychology, Center for Studies of Psychological Application, and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Xinmei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Xiangru', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cognition, Brain and Health, Institute of Psychology and Behavior, Henan University, Kaifeng, China.'}, {'ForeName': 'Ruida', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shangfeng', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yue-Jia', 'Initials': 'YJ', 'LastName': 'Luo', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China. Electronic address: luoyj@szu.edu.cn.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104804']
1648,32721845,Implementation of magnesium sulphate as an adjunct to multimodal analgesic approach for perioperative pain control in lumbar laminectomy surgery: A randomized placebo-controlled clinical trial.,"OBJECTIVE


To investigate the effect of systemic intraoperative administration of magnesium sulphate when used in the context of a multimodal pain management plan on analgesics consumption and pain scores, and perioperative outcomes after lumbar laminectomy surgery.
METHODS


Seventy-four patients undergoing lumbar laminectomy were enrolled in this randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to receive magnesium (20 mg/kg iv given as bolus before anesthesia induction followed by 20 mg/kg/h civ until surgery completion) or saline. Hemodynamic variables and desflurane consumption were noted at predefined time-intervals intraoperatively. Primary outcome was postoperative cumulative analgesic consumption over 24 h, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24 h), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points.
RESULTS


Demographics, surgery duration, desflurane requirements, and recovery profile were comparable between groups. Magnesium attenuated hemodynamic response during incision and emergence from anesthesia. Postoperative analgesics consumption in morphine iv equivalents (mean difference -9.24 [95 %CI -13.31, -5.17] mg; p = 0.001) and VAS scores at all-time points of assessment were lower in magnesium group; this effect peaked at 4 h (mean difference -2.15 [95 %CI -3.21,-1.09; p = 0.001]. Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01). No notable adverse effects were recorded.
CONCLUSION


It occurs that magnesium infusion during lumbar laminectomy surgery potentiates perioperative analgesia and reduces analgesic requirements up to 24 h postoperatively. No profound adverse effect on either intraoperative hemodynamics or any other clinically relevant endpoints becomes evident.",2020,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"['lumbar laminectomy surgery', 'Seventy-four patients undergoing lumbar laminectomy']","['Magnesium', 'placebo', 'magnesium (20\u202fmg/kg iv given as bolus before anesthesia induction followed by 20\u202fmg/kg/h civ until surgery completion) or saline', 'magnesium sulphate', 'magnesium', 'morphine']","['adverse effects', 'time-interval to first rescue analgesia', 'intraoperative remifentanil consumption', 'analgesics consumption and pain scores, and perioperative outcomes', 'postoperative cumulative analgesic consumption over 24\u202fh, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24\u202fh), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points', 'analgesic requirements', 'hemodynamic response', 'Postoperative analgesics consumption', 'Hemodynamic variables and desflurane consumption', 'Demographics, surgery duration, desflurane requirements, and recovery profile', 'VAS scores']","[{'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.791883,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tsaousi', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: tsaousig@otenet.gr.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Nikopoulou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: anastasian1991@windowslive.com.'}, {'ForeName': 'Ioakeim', 'Initials': 'I', 'LastName': 'Pezikoglou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: makispez@gmail.com.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Birba', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: bsbvasso@yahoo.gr.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Grosomanidis', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: grosoman@otenet.gr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106091']
1649,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1650,32740306,Integration of Person-Centered Narratives into the Electronic Health Record: Study Protocol.,"BACKGROUND


Incorporating a patient's personal narrative into the electronic health record (EHR) is an opportunity to more fully integrate the patient's values and beliefs into care, thus creating opportunities to deliver high-quality/high-value, person-centered care.
OBJECTIVES


To present a study protocol of a narrative intervention that aims to: (a) compare the effects of the narrative intervention to usual care on primary outcome of person's (patient) perceptions of quality of communication; (b) compare the effects of the narrative intervention on secondary outcomes of biopsychosocial well-being; and (c) examine the feasibility and acceptability of the narrative intervention from the perspective of both persons: the patient and the acute care bedside nurse.
METHODS


A randomized control trial is being conducted with a targeted enrollment of 80 patient participants and 80 nurse participants. The patient participants include individuals who are admitted to the acute care hospital for either heart failure or end-stage renal disease. An acute care beside nurse who has cared for the patient participant is also enrolled. Through a 1:1 random allocation scheme, stratified by illness, we will enroll 40 in the narrative intervention group and 40 in the usual care group. Patient participants will be assessed for patient-reported outcomes of patient's perception of quality of communication and biopsychosocial well-being.
RESULTS


The study began in October 2019; 53 potential patient participants have been approached, 21 have enrolled, and 20 have completed the data collection process.
DISCUSSION


The testing and integration of a person-centered narrative into the EHR is a novel approach to provide opportunities for improvement in communication between patients and nurses. The results from this study will provide important preliminary knowledge to inform future randomized clinical trials of narrative interventions leading to advances in how to best provide high-value, high-quality, person-centered care for persons living with serious illness.",2020,The testing and integration of a person-centered narrative into the EHR is a novel approach to provide opportunities for improvement in communication between patients and nurses.,"['80 patient participants and 80 nurse participants', 'October 2019; 53 potential patient participants have been approached, 21 have enrolled, and 20 have completed the data collection process', 'patient participants include individuals who are admitted to the acute care hospital for either heart failure or end-stage renal disease', 'persons living with serious illness']","['narrative intervention', 'narrative intervention to usual care']","['feasibility and acceptability', ""patient's perception of quality of communication and biopsychosocial well-being""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0644748,The testing and integration of a person-centered narrative into the EHR is a novel approach to provide opportunities for improvement in communication between patients and nurses.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Coats', 'Affiliation': 'University of Colorado College of Nursing, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Shive', 'Affiliation': 'University of Colorado College of Nursing, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ardith', 'Initials': 'A', 'LastName': 'Doorenbos', 'Affiliation': 'University of Illinois-Chicago College of Nursing.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Colorado School of Public Health, Aurora, Colorado.'}]",Nursing research,['10.1097/NNR.0000000000000463']
1651,32720113,The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer.,"PURPOSE


Chemotherapy-induced diarrhoea (CID) is a common, but often underreported problem in patients with breast cancer that has a profound effect on quality of life. It is best measured from a patient's perspective, but tools are limited. The aim of this study was to develop and evaluate the Diarrhoea Management Diary (DMD), a self-report measure to assess CID, use of self-management strategies and treatment adherence.
METHODS


The DMD was constructed using an iterative process of instrument development: concept elicitation (literature review), item generation and reduction (cognitive debriefing), and pilot testing in the target population. After translation into eight languages, the DMD was used in an international randomised trial for women receiving lapatinib and capecitabine for metastatic breast cancer with or without prophylactic octreotide. Patterns of missing data and sensitivity to change were examined.
RESULTS


The understandability and completeness of the 8-item DMD was confirmed in cognitive interviews and pilot testing. Practicability of the DMD was evaluated in 62 women with metastatic breast cancer (median age 57). Up to 68% reported CID at any given time-point, and 19% had diarrhoea at each time-point. Patients also described efficacy of different strategies for diarrhoea management. Missing data were associated with study discontinuation. DMD missing item response was 0.9%. Sensitivity to change was good at most assessment points.
CONCLUSIONS


Although further psychometric testing is recommended, initial evaluation of the DMD showed good content validity and practicability in international research with cancer patients.",2020,"Up to 68% reported CID at any given time-point, and 19% had diarrhoea at each time-point.","['patients with metastatic breast cancer', 'patients with breast cancer', '62 women with metastatic breast cancer (median age 57', 'for metastatic breast cancer with or without']","['lapatinib and capecitabine', 'prophylactic octreotide', 'Diarrhoea Management Diary (DMD']","['DMD missing item response', 'diarrhoea', 'understandability and completeness of the 8-item DMD', 'Diarrhoea Management Diary (DMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C1171188', 'cui_str': 'Diarrhea care'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C1171188', 'cui_str': 'Diarrhea care'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}]",62.0,0.0344362,"Up to 68% reported CID at any given time-point, and 19% had diarrhoea at each time-point.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Harder', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK. h.harder@sussex.ac.uk.'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Shilling', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Shirley F', 'Initials': 'SF', 'LastName': 'May', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK.'}, {'ForeName': 'Lesley J', 'Initials': 'LJ', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05798-w']
1652,32725584,"Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients ≥ 65 years with Overactive Bladder-Wet.","BACKGROUND


In older patients with overactive bladder (OAB), mirabegron, a β 3 -adrenoreceptor agonist, represents an alternative treatment that may have a favorable risk-benefit profile.
OBJECTIVES


Our objective was to further examine the safety and tolerability of mirabegron versus placebo treatment in patients aged ≥ 65 years with OAB-wet.
METHODS


We conducted a 12-week, double-blind, randomized, placebo-controlled phase IV study to compare mirabegron with placebo. Community-dwelling patients aged ≥ 65 years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24 h over a 3-day diary) were randomized to receive placebo or mirabegron 25 mg/day (optional dose escalation to 50 mg/day at week 4 or 8). Safety analyses were performed for adverse events (AEs) and vital signs on all randomized patients who received one or more dose of study drug.
RESULTS


Treatment-emergent AEs (TEAEs), the majority mild or moderate in severity, were reported in 39.4% of placebo patients and 44.2 and 49.8% of those who received mirabegron 25 mg or 50 mg, respectively. The most common TEAEs in mirabegron-treated patients were urinary tract infection, headache, and diarrhea. The incidence of TEAEs was slightly higher in mirabegron patients aged ≥ 75 years than in those aged < 75 years. There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups. TEAEs tended to occur early post exposure and were not dose related.
CONCLUSIONS


Mirabegron treatment was well-tolerated in older adults with OAB-wet. Safety and tolerability were consistent with the known mirabegron safety profile.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov: NCT02216214.",2020,"There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups.","['patients aged\u2009≥', '65\xa0years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24\xa0h over a 3-day diary', 'older adults with OAB-wet', '65\xa0years with OAB-wet', 'Patients\u2009≥', '65\xa0years with Overactive Bladder-Wet', 'Community-dwelling patients aged\u2009≥', 'older patients with overactive bladder (OAB']","['Placebo', 'placebo']","['vital signs', 'Safety and tolerability', 'safety and tolerability', 'incidence of TEAEs', 'Safety and Tolerability', 'urinary tract infection, headache, and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.543871,"There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups.","[{'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Surgery/Urology, Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, MG408, Toronto, Ontario, M4N 3M5, Canada. s.herschorn@utoronto.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': ""Division of Urology, St Elizabeth's Medical Center, 736 Cambridge Street, Brighton, MA, USA.""}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Schermer', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Department of Medicine, University of Alberta, 1-198 Clinical Sciences Building, 11350 83 Avenue, Edmonton, AB, Canada.'}]",Drugs & aging,['10.1007/s40266-020-00783-w']
1653,32722084,Effects of Supplementary Strength-Power Training on Neuromuscular Performance in Young Female Athletes.,"This study examined the effects of a short-duration supplementary strength-power training program on neuromuscular performance and sport-specific skills in adolescent athletes. Twenty-three female ""Gymnastics for All"" athletes, aged 13 ± 2 years, were divided into a training group (TG,  n  = 12) and a control group (CG,  n  = 11). Both groups underwent a test battery before and after 10 weeks of intervention. TG completed, in addition to gymnastics training, a supplementary 7-9 min program that included two rounds of strength and power exercises for arms, torso, and legs, executed in a circuit fashion with 1 min rest between rounds, three times per week. Initially, six exercises were performed (15 s work-15 s rest), while the number of exercises was decreased to four and the duration of each exercise was increased to 30 s (30 s rest) after the fifth week. TG improved countermovement jump performance with one leg (11.5% ± 10.4%,  p  = 0.002) and two legs (8.2% ± 8.8%,  p  = 0.004), drop jump performance (14.4% ± 12.6%,  p  = 0.038), single-leg jumping agility (13.6% ± 5.2%,  p  = 0.001), and sport-specific performance (8.8% ± 7.4%,  p  = 0.004), but not 10 m sprint performance (2.4% ± 6.6%,  p  = 0.709). No change was observed in the CG ( p  = 0.41 to 0.97). The results of this study indicated that this supplementary strength-power program performed for 7-9 min improves neuromuscular and sport-specific performance after 10 weeks of training.",2020,"TG improved countermovement jump performance with one leg (11.5% ± 10.4%,  p  = 0.002) and two legs (8.2% ± 8.8%,  p  = 0.004), drop jump performance (14.4% ± 12.6%,  p  = 0.038), single-leg jumping agility (13.6% ± 5.2%,  p  = 0.001), and sport-specific performance (8.8% ± 7.4%,  p  = 0.004), but not 10 m sprint performance (2.4% ± 6.6%,  p  = 0.709).","['Twenty-three female ""Gymnastics for All"" athletes, aged 13 ± 2 years', 'adolescent athletes', 'Young Female Athletes']","['short-duration supplementary strength-power training program', 'Supplementary Strength-Power Training']","['single-leg jumping agility', 'neuromuscular performance and sport-specific skills', 'Neuromuscular Performance', 'neuromuscular and sport-specific performance', 'drop jump performance', 'number of exercises', 'sport-specific performance', 'countermovement jump performance']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",6.0,0.012243,"TG improved countermovement jump performance with one leg (11.5% ± 10.4%,  p  = 0.002) and two legs (8.2% ± 8.8%,  p  = 0.004), drop jump performance (14.4% ± 12.6%,  p  = 0.038), single-leg jumping agility (13.6% ± 5.2%,  p  = 0.001), and sport-specific performance (8.8% ± 7.4%,  p  = 0.004), but not 10 m sprint performance (2.4% ± 6.6%,  p  = 0.709).","[{'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Karagianni', 'Affiliation': 'School of Physical Education and Sports Science, National and Kapodistrian University of Athens, 17237 Athens, Greece.'}, {'ForeName': 'Olyvia', 'Initials': 'O', 'LastName': 'Donti', 'Affiliation': 'School of Physical Education and Sports Science, National and Kapodistrian University of Athens, 17237 Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Katsikas', 'Affiliation': 'School of Physical Education and Sports Science, National and Kapodistrian University of Athens, 17237 Athens, Greece.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Bogdanis', 'Affiliation': 'School of Physical Education and Sports Science, National and Kapodistrian University of Athens, 17237 Athens, Greece.'}]","Sports (Basel, Switzerland)",['10.3390/sports8080104']
1654,32722985,UK primary care survey of venous leg ulceration management and referral - Post-EVRA trial.,"OBJECTIVE


Determine standards of referral and management of patients with venous leg ulceration in primary care after the release of the EVRA (A Randomized Trial of Early Endovenous Ablation in Venous Ulceration) study results.
METHODS


An online questionnaire was disseminated over four months to professionals working within primary care.
RESULTS


The survey received 643 responses. Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results. Of those who answered the following questions, 410 (69.1%) stated that referral to a vascular specialist must be made by the General Practitioner and 13 (2.2%) reported that they would always refer patients for secondary care assessment before the publication of EVRA. Considering the EVRA results, 128 (29%) reported that they would change practice regarding referral and would experience no barriers and 198 (45%) reported that they would like to refer earlier but is not their decision. Barriers to changing practice included local referral policies, training and time restrictions, 266 (59%) had heard of the NICE guideline (CG168) and 194 (43%) were aware of the recommendations for referral to a vascular service within two weeks for patients with an open or healed ulcer.
CONCLUSION


There is a considerable variation in local referral pathways for venous leg ulceration, and despite clinicians wanting to refer promptly, many primary care professionals are unable to. Unfortunately, the EVRA study alone may not change the overall practice, and work is needed to overcome barriers faced by primary care professionals.",2020,"Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results.","['An online questionnaire was disseminated over four months to professionals working within primary care', '266 (59%) had heard of the NICE guideline (CG168) and 194 (43%) were aware of the recommendations for referral to a vascular service within two weeks for patients with an open or healed ulcer', 'patients with venous leg ulceration in primary care after the release of the', 'Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results']",['EVRA'],[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C5200009', 'cui_str': 'Evra'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C5200009', 'cui_str': 'Evra'}]",[],,0.0331104,"Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results.","[{'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Heatley', 'Affiliation': 'Imperial Health Care NHS Trust, Imperial College London, London, UK.'}, {'ForeName': 'Layla B', 'Initials': 'LB', 'LastName': 'Saghdaoui', 'Affiliation': 'Imperial Health Care NHS Trust, Imperial College London, London, UK.'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Salim', 'Affiliation': 'Imperial Health Care NHS Trust, Imperial College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Onida', 'Affiliation': 'Imperial Health Care NHS Trust, Imperial College London, London, UK.'}, {'ForeName': 'Manj S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Addenbrookes Hospital, Imperial College, Cambridge, London, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Imperial Health Care NHS Trust, Imperial College London, London, UK.'}]",Phlebology,['10.1177/0268355520944102']
1655,32723680,Same-day discharge after elective percutaneous coronary intervention: A single center experience.,"INTRODUCTION AND OBJECTIVES


Elective percutaneous coronary intervention (PCI) has become an increasingly safe procedure. However, same day discharge (SDD) has yet to become standard practice. Our aim is to characterize the patients who underwent elective PCI and compare outcomes between the overnight stay (ONS) patient group and the group that was discharged on the same day at 24 hours and at 30 days.
METHODS


One-year registry of patients who underwent an elective PCI. The possibility of SDD was established by the operator. Appropriate candidates were discharged at least four hours after the end of the intervention. The primary endpoints were defined as: Major adverse cardiac and cerebrovascular events (MACCE) - death, myocardial infarction (MI) stroke or transient ischemic attack (TIA), non-planned re-intervention - and vascular complications. Secondary endpoints were any unplanned hospital visit, readmission and re-catheterization.
RESULTS


We performed 155 elective PCIs. One patient was admitted to the coronary care unit; 111 patients stayed overnight (ONS Group); 43 patients were discharged the same day (SDD Group). Three patients had early (<4 hours) post procedure complications: two TIAs and one vascular access site complication. There were no MACCE between four and 24 hours, nor at 30 days. At 24 hours, two patients from the SDD group had unplanned visits. Between one and 30 days, more patients from the SDD group had unplanned visits (9.3% vs. 0.9%. p=0.02). One patient from the ONS group had a recatherization. There were no readmissions or reinterventions.
CONCLUSION


Same day discharge of selected patients who undergo elective PCIs is feasible and safe.",2020,"There were no readmissions or reinterventions.
","['One-year registry of patients who underwent an elective PCI', 'One patient was admitted to the coronary care unit; 111 patients stayed overnight (ONS Group); 43 patients were discharged the same day (SDD Group']",['Elective percutaneous coronary intervention (PCI'],"['unplanned hospital visit, readmission and', 'Major adverse cardiac and cerebrovascular events (MACCE) - death, myocardial infarction (MI) stroke or transient ischemic attack (TIA), non-planned re-intervention - and vascular complications', 'unplanned visits', 'readmissions or reinterventions']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",155.0,0.0488091,"There were no readmissions or reinterventions.
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal. Electronic address: rodrigues.jal@gmail.com.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Almeida', 'Affiliation': 'Hospital do Divino Espírito Santo de Ponta Delgada, Ponta Delgada, Açores, Portugal.'}, {'ForeName': 'Francisco Castro', 'Initials': 'FC', 'LastName': 'Ferreira', 'Affiliation': 'Hospital da Senhora da Oliveira, Guimarães, Portugal.'}, {'ForeName': 'Gustavo Pires de', 'Initials': 'GP', 'LastName': 'Morais', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Santos', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Melica', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Braga', 'Affiliation': 'Centro Hospitalar de Gaia/Espinho, Vila Nova de Gaia, Portugal.'}]",Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de Cardiologia = Portuguese journal of cardiology : an official journal of the Portuguese Society of Cardiology,['10.1016/j.repc.2019.10.008']
1656,32728820,Exercise training improves vascular function in patients with Alzheimer's disease.,"PURPOSE


Vascular dysfunction has been demonstrated in patients with Alzheimer's disease (AD). Exercise is known to positively affect vascular function. Thus, the aim of our study was to investigate exercise-induced effects on vascular function in AD.
METHODS


Thirty-nine patients with AD (79 ± 8 years) were recruited and randomly assigned to exercise training (EX, n = 20) or control group (CTRL, n = 19). All subjects performed 72 treatment sessions (90 min, 3 t/w). EX included moderate-high-intensity aerobic and strength training. CTRL included cognitive stimuli (visual, verbal, auditive). Before and after the 6-month treatment, the vascular function was measured by passive-leg movement test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, %). A blood sample was analyzed for vascular endothelial growth factor (VEGF). Arterial blood flow (BF) and shear rate (SR) were measured during EX and CTRL during a typical treatment session.
RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ 99.056 ml/min, p = 0.004), AUC (+ 37.359AU, p = 0.037) and VEGF (+ 8.825 pg/ml, p = 0.004). In the CTRL group, no difference between pre- and post-treatment was found for any variable. Increase in BF and SR was demonstrated during EX (BF + 123%, p < 0.05; SR + 134%, p < 0.05), but not during CTRL treatment.
CONCLUSION


Exercise training improves peripheral vascular function in AD. These ameliorations may be due to the repetitive increase in SR during exercise which triggers NO and VEGF upregulation. This approach might be included in standard AD clinical practice as an effective strategy to treat vascular dysfunction in this population.",2020,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[""patients with Alzheimer's disease"", ""patients with Alzheimer's disease (AD"", 'Thirty-nine patients with AD (79\u2009±\u20098\xa0years']","['exercise training (EX, n\u2009=\u200920) or control group (CTRL', 'Exercise training']","['Arterial blood flow (BF) and shear rate (SR', 'CTRL included cognitive stimuli (visual, verbal, auditive', 'vascular endothelial growth factor (VEGF', 'passive-leg movement\xa0test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, ', 'FMD', 'PLM ∆peak ', 'moderate-high-intensity aerobic and strength training', 'peripheral vascular function', 'vascular function', 'BF and SR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",39.0,0.064598,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy. massimo.venturelli@univr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Di Baldassarre', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic Medicine and Orthopedic Science, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Giuriato', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ghinassi', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Mons. A. Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04447-w']
1657,32729888,Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial.,"Importance


Faricimab, the first bispecific antibody designed for intraocular use, simultaneously and independently binds and neutralizes angiopoietin 2 (Ang-2) and vascular endothelial growth factor A (VEGF-A).
Objective


To assess the efficacy and safety of different doses and regimens of faricimab vs ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
Design, Setting, and Participants


AVENUE was a 36-week, multiple-dose-regimen, active comparator-controlled, double-masked, phase 2 randomized clinical study performed at 58 sites in the United States. Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320). Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017. Data were analyzed from August 11, 2015, to October 4, 2019.
Interventions


Patients were randomized 3:2:2:2:3 to receive ranibizumab, 0.5 mg every 4 weeks (arm A [n = 68]); faricimab, 1.5 mg every 4 weeks (arm B [n = 47]); faricimab, 6.0 mg every 4 weeks (arm C [n = 42]); faricimab, 6.0 mg every 4 weeks until week 12, then faricimab, 6.0 mg every 8 weeks (arm D [n = 47]); and ranibizumab, 0.5 mg every 4 weeks until week 8, then faricimab, 6.0 mg every 4 weeks (arm E [n = 69]).
Main Outcomes and Measures


Mean change in BCVA from baseline to week 36, proportion of participants gaining at least 15 letters, BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes in anti-VEGF treatment-naive participants (arms A, B, C, D) and from weeks 12 to 36 in those with incomplete response (participants in arms A and E with week 12 BCVA ETDRS letter score of ≤68 [Snellen equivalent, 20/50 or worse]).
Results


A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years). At week 36, adjusted mean change in BCVA vs ranibizumab was 1.6 (80% CI, -1.6 to 4.7) letters for arm B (P = .52), -1.6 (80% CI, -4.9 to 1.7) letters for arm C (P = .53), and -1.5 (80% CI, -4.6 to 1.6) letters for arm D (P = .53). For arm E, adjusted mean change from week 12 was -1.7 (80% CI, -3.8 to 0.4) letters (P = .30).
Conclusions and Relevance


AVENUE did not meet its primary end point of superiority of faricimab over ranibizumab in BCVA at week 36. Although not superior to monthly ranibizumab as given in this trial, overall visual and anatomical gains noted with faricimab support pursuing phase 3 trials for a potential alternative to monthly anti-VEGF therapy. Faricimab showed no new or unexpected safety signals.
Trial Registration


ClinicalTrials.gov Identifier: NCT02484690.",2020,"For arm E, adjusted mean change from week 12 was -1.7","['Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017', 'A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years', 'Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320', 'Neovascular Age-Related Macular Degeneration', 'patients with neovascular age-related macular degeneration (nAMD', 'Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA']","['faricimab vs ranibizumab', 'Faricimab vs Ranibizumab', 'BCVA', 'ranibizumab']","['efficacy and safety', 'BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes', 'Safety and Efficacy']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",263.0,0.321469,"For arm E, adjusted mean change from week 12 was -1.7","[{'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sahni', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina Consultants, Abilene.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Chittum', 'Affiliation': 'Retina Consultants of Southern Colorado, Colorado Springs.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Retina Research Center, Austin, Texas.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Valle Rubido', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shamil', 'Initials': 'S', 'LastName': 'Sadikhov', 'Affiliation': 'Roche Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Szczesny', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Everson', 'Initials': 'E', 'LastName': 'Nogoceke', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weikert', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Fauser', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2685']
1658,32726364,Four weeks of augmented eccentric loading using a novel leg press device improved leg strength in well-trained athletes and professional sprint track cyclists.,"This study assessed the efficacy of strength training using augmented eccentric loading to provoke increases in leg strength in well-trained athletes, and sprint track cyclists, using a novel leg press device. Twelve well-trained athletes were randomly allocated traditional resistance training (TRAD, n = 6), or resistance training using augmented eccentric loading (AEL, n = 6). A further 5 full-time, professional sprint track cyclists from a senior national squad programme also trained with augmented eccentric loading (AEL-ATH) alongside their usual sport-specific training. Participants completed four weeks of twice-weekly resistance training using the leg press exercise. In TRAD the lowering phase of the lift was set relative to concentric strength. In AEL and AEL-ATH the lowering phase was individualised to eccentric strength. Concentric, eccentric, isometric and coupled eccentric-concentric leg press strength, and back squat 1 repetition maximum (1RM), were assessed pre- and post-training. The AEL and AEL-ATH groups performed the eccentric phase with an average 26 ± 4% greater load across the programme. All groups experienced increases in concentric (5%, 7% and 3% for TRAD, AEL & AEL-ATH respectively), eccentric (7%, 11% and 6% for TRAD, AEL & AEL-ATH respectively), and squat 1RM (all p < 0.05), where the AEL-ATH group experienced relatively greater increases (13% vs. 5% in TRAD and AEL, p < 0.01). The TRAD and AEL groups also increased isometric strength (p < 0.05). A four-week period of augmented eccentric loading increased leg strength in well-trained athletes and track cyclists. The eccentric leg press stimulus was well-tolerated, supporting the inclusion of such training in the preparation programmes of athletes.",2020,"All groups experienced increases in concentric (5%, 7% and 3% for TRAD, AEL & AEL-ATH respectively), eccentric (7%, 11% and 6% for TRAD, AEL & AEL-ATH respectively), and squat 1RM (all p < 0.05), where the AEL-ATH group experienced relatively greater increases (13% vs. 5% in TRAD and AEL, p < 0.01).","['Twelve well-trained athletes', 'well-trained athletes and track cyclists', 'well-trained athletes and professional sprint track cyclists']","['strength training', 'augmented eccentric loading', 'resistance training using the leg press exercise', 'traditional resistance training (TRAD, n = 6), or resistance training using augmented eccentric loading (AEL, n = 6']","['concentric', 'Concentric, eccentric, isometric and coupled eccentric-concentric leg press strength, and back squat 1 repetition maximum (1RM', 'leg strength', 'squat 1RM', 'isometric strength']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0023440', 'cui_str': 'Acute myeloid leukemia, M6 type'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0141622,"All groups experienced increases in concentric (5%, 7% and 3% for TRAD, AEL & AEL-ATH respectively), eccentric (7%, 11% and 6% for TRAD, AEL & AEL-ATH respectively), and squat 1RM (all p < 0.05), where the AEL-ATH group experienced relatively greater increases (13% vs. 5% in TRAD and AEL, p < 0.01).","[{'ForeName': 'Mellissa', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'English Institute of Sport, Manchester, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The Football Association, Burton on Trent, United Kingdom.'}, {'ForeName': 'Kirsty Marie', 'Initials': 'KM', 'LastName': 'Hicks', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0236663']
1659,32732587,Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients.,"OBJECTIVE


To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients.
DESIGN


A pilot factorial randomized controlled trial.
SETTING


Fifteen North American clinical sites.
PARTICIPANTS


Ninety-one adults 18-60 years of age with a femoral neck fracture requiring surgical fixation.
INTERVENTION


Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months).
MAIN OUTCOME MEASUREMENTS


The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing.
RESULTS


Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40-2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42-2.18, P = 0.92).
CONCLUSIONS


These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"We found no statistically significant difference in the risk of patient important outcomes between the surgical treatment arms (hazard ratio (HR) 0.90, 95% CI 0.40-2.02, p=0.80) and vitamin D supplementation treatment arms (HR 0.96, 95% CI 0.42- 2.18, p=0.92).
","['15 North American clinical sites', '91 adults aged 18-60 years with a femoral neck fracture requiring surgical fixation', 'Young Femoral Neck Fracture Patients', '86 participants with a mean age of 41 years were included', 'young fracture populations', '12 months of injury in non-geriatric femoral neck fracture patients', 'Hip Fractures (FAITH-2']","['surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4,000 IU daily versus placebo', 'fixation method and vitamin D supplementation', 'Fixation using Alternative Implants']","['composite of patient important complications (re-operation, femoral head osteonecrosis, severe femoral neck malunion, nonunion', 'healing outcomes', 'risk of patient important outcomes', 'fracture healing complications and radiographic fracture healing']","[{'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",91.0,0.184045,"We found no statistically significant difference in the risk of patient important outcomes between the surgical treatment arms (hazard ratio (HR) 0.90, 95% CI 0.40-2.02, p=0.80) and vitamin D supplementation treatment arms (HR 0.96, 95% CI 0.42- 2.18, p=0.92).
","[{'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'OʼToole', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Gaski', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Hill', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Krista M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Viskontas', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, New Westminster, BC, Canada.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Zomar', 'Affiliation': 'Division of Orthopaedics, Fraser Health Authority, New Westminster, BC, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Della Rocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia, MO.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': 'OʼHara', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001773']
1660,32734366,"A Multicentre, Randomised Clinical Trial to Compare a Topical Nitrizinc ®  Complex Solution Versus Cryotherapy for the Treatment of Anogenital Warts.","INTRODUCTION


Anogenital warts (AGW) are a relevant clinical issue in the field of sexually transmitted disease, and to date no treatment provides a satisfactory clearance rate. Treatment can be both medical and surgical, and be provided by a healthcare provider or by the patient. Cryotherapy (CRYO) is among the most common treatments for AGW. Nitrizinc® Complex solution (NZCS) is a solution containing organic acids, nitric acid and zinc and copper salts that is applied topically to warts, producing mummification of the damaged tissue. It is considered to be an effective and well-tolerated treatment for genital and common warts. The aim of our study was to compare NZCS to CRYO in the treatment of AGW.
METHODS


We performed a prospective, multicentre, single-blind, randomised, superiority clinical study involving 120 patients, aged 18-55 years, diagnosed with a first episode of AGW, with each patient having from three to ten AGW. The patients were treated either with NZCS or CRYO for a maximum of four treatments. Primary endpoints were: (1) comparison of the clinical efficacy of CRYO and NZCS, based on response to treatment (clearance of AGW) within four treatment sessions; and (2) tolerability, assessed via a short questionnaire at the end of each treatment session. Secondary endpoints were: (1) number of treatments needed for clearance; and (2) recurrence at 1 and 3e months after confirmed clearance. The results were analysed on an intention-to-treat basis.
RESULTS


A complete response was achieved in 89.7% of the NZCS group and in 75.4% of the CRYO group (p = 0.0443). NZCS was found to be better tolerated. There was no difference between the NZCS and CRYO treatment arms in the number of sessions needed to clear the lesions. Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
CONCLUSIONS


Nitrizinc® Complex solution can be considered to be as effective as CRYO for the treatment of small (< 5 mm) external AGW, with a better tolerability profile and lower rate of recurrence.
TRIAL REGISTRATION


ISRCTN identifier, ISRCTN36102369.",2020,"Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
","['120 patients, aged 18-55\xa0years, diagnosed with a first episode of AGW, with each patient having from three to ten AGW', 'Anogenital Warts']","['Nitrizinc® Complex solution (NZCS', 'Topical Nitrizinc ®  Complex Solution Versus Cryotherapy', 'Cryotherapy (CRYO', 'NZCS or CRYO', 'NZCS']","['number of sessions needed to clear the lesions', 'tolerated', 'Recurrence', 'clinical efficacy of CRYO and NZCS, based on response to treatment (clearance of AGW) within four treatment sessions; and (2) tolerability, assessed via a short questionnaire', '1) number of treatments needed for clearance; and (2) recurrence']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",120.0,0.0861442,"Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pontini', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy. pontini.p@gmail.com.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mastorino', 'Affiliation': 'Dermatology Clinic, Department of Medical Sciences, Azienda Ospedaliera Universitaria Città della Salute e della Scienza-University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gaspari', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Granger', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ramoni', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Delmonte', 'Affiliation': 'Dermatology Clinic, Department of Medical Sciences, Azienda Ospedaliera Universitaria Città della Salute e della Scienza-University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Evangelista', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cusini', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy.""}]",Dermatology and therapy,['10.1007/s13555-020-00430-7']
1661,32734932,Effectiveness of a Theory- and Web-Based Adaptive Implementation Intervention on Nurses' and Nursing Students' Intentions to Provide Brief Counseling: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by nurses is difficult due to contextual and practitioner-level factors impeding nurses' motivation and intentions to provide brief counseling (eg, unfavorable attitude toward brief counseling, lack of perceived control linked to barriers). Theory-based implementation interventions could address these practitioner-level factors and support evidence-based practice in the context of brief counseling. Web-based, adaptive e-learning (electronic learning) programs are a novel type of implementation intervention that could address the limitations of current brief counseling training programs, such as accessibility and personalization.
OBJECTIVE


This paper presents a study protocol for evaluating the effectiveness of the E_MOTIV A  implementation intervention-a theory- and web-based adaptive e-learning program-to increase nurses' and nursing students' intentions to provide brief counseling for smoking, an unbalanced diet, and medication nonadherence.
METHODS


A two-group, single-blind, randomized controlled trial will be conducted with nurses and nursing students enrolled in a Bachelor of Science in Nursing program in Quebec, Canada. Participants in the experimental group will be allocated to the E_MOTIV A  intervention-a theory- and web-based adaptive e-learning program-while participants in the active control group will be allocated to the E_MOTIV B  intervention, a knowledge- and web-based standardized e-learning program. The E_MOTIV A  intervention was designed to influence the constructs of the Theory of Planned Behavior (eg, attitude, subjective norms, and perceived behavioral control) in the context of brief counseling. The Cognitive Load Index and User Engagement Scale will be used to assess participants' cognitive load and engagement related to e-learning. Participants will complete the Brief Counseling Nursing Practices Questionnaire-Abridged Version at baseline and follow-up. All study measures will be completed online.
RESULTS


The study is ongoing. The results of the study will provide answers to the primary hypothesis (H1) that experimental group participants will demonstrate a greater change in the score of intentions to provide brief counseling between baseline (-T1) and follow-up (T4). Secondary hypotheses include greater improvements in scores of attitude (H2), subjective norms (H3), perceived control (H4), behavioral beliefs (H5), normative beliefs (H6), and control beliefs (H7) regarding brief counseling in the experimental group between baseline and follow-up. We also anticipate lower intrinsic and extrinsic cognitive loads (H8, H9), higher germane cognitive load (H10), and higher engagement (H11, H12) in the experimental group.
CONCLUSIONS


This study will be among the first in evaluating a novel type of implementation intervention, a theory- and web-based adaptive e-learning program, in nurses and nursing students. This type of intervention has the potential to support evidence-based practice through accessible, personalized training in wide-ranging domains in nursing.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN32603572; http://www.isrctn.com/ISRCTN32603572.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18894.",2020,"Secondary hypotheses include greater improvements in scores of attitude (H2), subjective norms (H3), perceived control (H4), behavioral beliefs (H5), normative beliefs (H6), and control beliefs (H7) regarding brief counseling in the experimental group between baseline and follow-up.","['nurses and nursing students enrolled in a Bachelor of Science in Nursing program in Quebec, Canada', 'nurses and nursing students', ""Nurses' and Nursing Students' Intentions to Provide Brief Counseling""]","['intervention-a theory- and web-based adaptive e-learning program-while participants in the active control group will be allocated to the E_MOTIV B  intervention, a knowledge- and web-based standardized e-learning program', 'Theory- and Web-Based Adaptive Implementation Intervention', 'implementation intervention-a theory- and web-based adaptive e-learning program']","['scores of attitude (H2), subjective norms (H3), perceived control (H4), behavioral beliefs (H5), normative beliefs (H6), and control beliefs (H7) regarding brief counseling', 'intrinsic and extrinsic cognitive loads (H8, H9), higher germane cognitive load (H10), and higher engagement (H11, H12']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0643681', 'cui_str': 'RHOA protein, human'}]",,0.0339233,"Secondary hypotheses include greater improvements in scores of attitude (H2), subjective norms (H3), perceived control (H4), behavioral beliefs (H5), normative beliefs (H6), and control beliefs (H7) regarding brief counseling in the experimental group between baseline and follow-up.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Fontaine', 'Affiliation': 'Research Center, Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Cossette', 'Affiliation': 'Research Center, Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Gagnon', 'Affiliation': 'Faculty of Nursing, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dubé', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, QC, Canada.'}]",JMIR research protocols,['10.2196/18894']
1662,32730310,Monetary incentives for improving smartphone-measured oral hygiene behaviors in young children: A randomized pilot trial.,"AIMS


To assess feasibility, acceptability, and early efficacy of monetary incentive-based interventions on fostering oral hygiene in young children measured with a Bluetooth-enabled toothbrush and smartphone application.
DESIGN


A stratified, parallel-group, three-arm individually randomized controlled pilot trial.
SETTING


Two Los Angeles area Early Head Start (EHS) sites.
PARTICIPANTS


36 parent-child dyads enrolled in an EHS home visit program for 0-3 year olds.
INTERVENTIONS


Eligible dyads, within strata and permuted blocks, were randomized in equal allocation to one of three groups: waitlist (delayed monetary incentive) control group, fixed monetary incentive package, or lottery monetary incentive package. The intervention lasted 8 weeks.
OUTCOMES


Primary outcomes were a) toothbrushing performance: mean number of Bluetooth-recorded half-day episodes per week when the child's teeth were brushed, and b) dental visit by the 2-month follow-up among children with no prior dental visit. The a priori milestone of 20% more frequent toothbrushing identified the intervention for a subsequent trial. Feasibility and acceptability measures were also assessed, including frequency of parents syncing the Bluetooth-enabled toothbrush to the smartphone application and plaque measurement from digital photographs.
FINDINGS


Digital monitoring of toothbrushing was feasible. Mean number of weekly toothbrushing episodes over 8 weeks was 3.9 in the control group, 4.1 in the fixed incentive group, and 6.0 in the lottery incentive group. The lottery group had 53% more frequent toothbrushing than the control group and 47% more frequent toothbrushing than the fixed group. Exploratory analyses showed effects concentrated among children ≤24 months. Follow-up dental visit attendance was similar across groups. iPhone 7 more reliably captured evaluable images than Photomed Cannon G16.
CONCLUSIONS


Trial protocol and outcome measures were deemed feasible and acceptable. Results informed the study protocol for a fully powered trial of lottery incentives versus a delayed control using the smart toothbrush and remote digital incentive program administration.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03862443.",2020,The lottery group had 53% more frequent toothbrushing than the control group and 47% more frequent toothbrushing than the fixed group.,"['young children', 'young children measured with a Bluetooth-enabled toothbrush and smartphone application', 'Two Los Angeles area', '36 parent-child dyads enrolled in an EHS home visit program for 0-3 year olds']","['monetary incentive-based interventions', 'waitlist (delayed monetary incentive) control group, fixed monetary incentive package, or lottery monetary incentive package']","['Mean number of weekly toothbrushing episodes', ""toothbrushing performance: mean number of Bluetooth-recorded half-day episodes per week when the child's teeth were brushed, and b) dental visit"", 'Feasibility and acceptability measures', 'frequent toothbrushing', 'feasibility, acceptability, and early efficacy', 'smartphone-measured oral hygiene behaviors']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0928108,The lottery group had 53% more frequent toothbrushing than the control group and 47% more frequent toothbrushing than the fixed group.,"[{'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramos-Gomez', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'Jenny X', 'Initials': 'JX', 'LastName': 'Liu', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Jue', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Finlayson', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'Jeremiah R', 'Initials': 'JR', 'LastName': 'Garza', 'Affiliation': 'Section of Pediatric Dentistry, School of Dentistry, University of California Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Crawford', 'Affiliation': 'California Protons Cancer Therapy Center, University of California San Diego Health, San Diego, California, United States of America.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Helman', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Santo', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ""Center to Address Disparities in Children's Oral Health, University of California San Francisco, San Francisco, California, United States of America.""}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Gansky', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0236692']
1663,32730325,The safety and feasibility of a Halliwick style of aquatic physiotherapy for falls and balance dysfunction in people with Parkinson's Disease: A single blind pilot trial.,"BACKGROUND


There is growing evidence that aquatic physiotherapy may be effective for people with Parkinson's Disease (PD) but most studies have investigated land based type exercises in the aquatic environment. Few studies have examined customised aquatic therapies such as the Halliwick concept which focuses on trunk rotation and core stabilisation.
OBJECTIVE


The primary aim was to determine the feasibility of a Halliwick style aquatic physiotherapy intervention for people with PD. The secondary aim was to compare the Halliwick intervention with traditional aquatic and land based physiotherapy in terms of disease severity, balance and fear of falling.
METHODS


Halliwick style aquatic, traditional aquatic and land based physiotherapy were trialled in a single blind pilot study. All interventions ran for 60 minutes per week over 12 weeks. Feasibility outcomes were safety, adherence and attrition. Secondary outcomes included the Unified Parkinson's Disease Rating Scale motor subsection (UPDRS-III), Berg Balance Scale (BBS), Mini BESTest and modified Falls Efficacy Scale (mFES).
RESULTS


30 participants with moderate PD were recruited. Participant mean age was 72 years (SD 8.4; range 51-86) with moderate disease severity (median Hoehn & Yahr score 3; IQR 1).No falls occurred during intervention sessions, however ten participants reported falls during the study period. No other adverse consequences were reported. All groups had adherence over 85%. No within group significant differences were found in UPDRS-III, BBS or mFES scores post-intervention for all groups, but the Halliwick aquatic group improved significantly in the Mini BESTest post-intervention (p = 0.011, 95% CI -7.36,-1.31, t (10) = -2.98).
CONCLUSIONS


Despite people with PD being a vulnerable population, aquatic physiotherapy, including the Halliwick style is a safe treatment option. Promising results for balance in the Halliwick aquatic group were observed, but further studies with larger sample sizes is required to increase confidence in the results.",2020,"No within group significant differences were found in UPDRS-III, BBS or mFES scores post-intervention for all groups, but the Halliwick aquatic group improved significantly in the Mini BESTest post-intervention (p = 0.011, 95% CI -7.36,-1.31, t (10) = -2.98).
","['Participant mean age was 72 years (SD 8.4; range 51-86) with moderate disease severity (median Hoehn & Yahr score 3; IQR 1).No falls occurred during intervention sessions, however ten participants reported falls during the study period', ""people with Parkinson's Disease"", '30 participants with moderate PD', ""people with Parkinson's Disease (PD"", 'people with PD']","['Halliwick style aquatic, traditional aquatic and land based physiotherapy', 'aquatic physiotherapy', 'Halliwick style aquatic physiotherapy intervention', 'Halliwick intervention with traditional aquatic and land based physiotherapy', 'Halliwick style of aquatic physiotherapy']","['safety, adherence and attrition', 'UPDRS-III, BBS or mFES scores', 'adverse consequences', 'disease severity, balance and fear of falling', ""Unified Parkinson's Disease Rating Scale motor subsection (UPDRS-III), Berg Balance Scale (BBS"", 'Mini BESTest and modified Falls Efficacy Scale (mFES']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]",30.0,0.0617848,"No within group significant differences were found in UPDRS-III, BBS or mFES scores post-intervention for all groups, but the Halliwick aquatic group improved significantly in the Mini BESTest post-intervention (p = 0.011, 95% CI -7.36,-1.31, t (10) = -2.98).
","[{'ForeName': 'Aan Fleur', 'Initials': 'AF', 'LastName': 'Terrens', 'Affiliation': 'Movement Disorder Program, Peninsula Health, VIC, Australia.'}, {'ForeName': 'Sze-Ee', 'Initials': 'SE', 'LastName': 'Soh', 'Affiliation': 'Department of Physiotherapy, Monash University, VIC, Australia.'}, {'ForeName': 'Prue', 'Initials': 'P', 'LastName': 'Morgan', 'Affiliation': 'Department of Physiotherapy, Monash University, VIC, Australia.'}]",PloS one,['10.1371/journal.pone.0236391']
1664,32730437,[Effect of the presence of student-assistants on the quality of care perception by ambulatory patients].,"BACKGROUND


The time dedicated to patients and how they are treated are crucial in the evaluation of health care quality. Medical students acting as medical assistants could improve the perception of a good quality of care among ambulatory patients.
AIM


To evaluate if the presence of Student-Assistants improves the patients' perception of health care quality in ambulatory primary care.
PATIENTS AND METHODS


Quasi-experimental exploratory study. In two health care centers, patients answered a questionnaire about their perception of how they were treated at baseline and after an intervention period. In one center, prior to the appointment of the patient with the doctor, the student interviewed patients focusing on chief complaints and registered their vital signs, orally presenting this information to the clinician. In the other center, there was no student intervention. Patients answered the questionnaire at the end of appointments.
RESULTS


At baseline 103 patients answered the questionnaire (58 in the experimental and 45 in the control center). After the intervention, 121 patients answered it (56 in the experimental and 65 in the control center). Basal scores were 6,25 and 6,06 in experimental and control center, respectively (p = NS). After the intervention, the scores were 6,49 and 6,15, respectively (p = 0,01).
CONCLUSIONS


These data support the hypothesis that the presence of a Student-Assistant could improve the perception of patients about how they are treated at primary health care centers.",2020,"After the intervention, the scores were 6,49 and 6,15, respectively (p = 0,01).
","['At baseline 103 patients answered the questionnaire (58 in the experimental and 45 in the control center', 'ambulatory patients', '121 patients answered it (56 in the experimental and 65 in the control center']",['student-assistants'],"['quality of care perception', 'Basal scores']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}]","[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",121.0,0.0179607,"After the intervention, the scores were 6,49 and 6,15, respectively (p = 0,01).
","[{'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Concha I', 'Affiliation': 'Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hirschberg G', 'Affiliation': 'Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Arraño R', 'Affiliation': 'Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Cárcamo I', 'Affiliation': 'Departamento de Salud Pública y Epidemiología, Facultad de Medicina, Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Mañalich M', 'Affiliation': 'Departamento de Salud Pública y Epidemiología, Facultad de Medicina, Universidad de los Andes, Santiago, Chile.'}]",Revista medica de Chile,['10.4067/S0034-98872020000100060']
1665,32738955,"Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial.","BACKGROUND


Treatment of dysplastic Barrett's oesophagus prevents progression to adenocarcinoma; however, the optimal diagnostic strategy for Barrett's oesophagus is unclear. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus. The aim of this study was to investigate whether offering this test to patients on medication for gastro-oesophageal reflux would increase the detection of Barrett's oesophagus compared with standard management.
METHODS


This multicentre, pragmatic, randomised controlled trial was done in 109 socio-demographically diverse general practice clinics in England. Randomisation was done both at the general practice clinic level (cluster randomisation) and at the individual patient level, and the results for each type of randomisation were analysed separately before being combined. Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years. General practice clinics were selected by the local clinical research network and invited to participate in the trial. For cluster randomisation, clinics were randomly assigned (1:1) by the trial statistician using a computer-generated randomisation sequence; for individual patient-level randomisation, patients were randomly assigned (1:1) by the general practice clinics using a centrally prepared computer-generated randomisation sequence. After randomisation, participants received either standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group). The primary outcome was the diagnosis of Barrett's oesophagus at 12 months after enrolment, expressed as a rate per 1000 person-years, in all participants in the intervention group (regardless of whether they had accepted the offer of the Cytosponge-TFF3 procedure) compared with all participants in the usual care group. Analyses were intention-to-treat. The trial is registered with the ISRCTN registry, ISRCTN68382401, and is completed.
FINDINGS


Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation. Using an automated search of the electronic prescribing records of the remaining 109 clinics, we identified 13 657 eligible patients who were sent an introductory letter with 14 days to opt out. 13 514 of these patients were randomly assigned (per practice or at the individual patient level) to the usual care group (n=6531) or the intervention group (n=6983). Following randomisation, 149 (2%) of 6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study. Of the remaining 6834 participants in the intervention group, 2679 (39%) expressed an interest in undergoing the Cytosponge-TFF3 procedure. Of these, 1750 (65%) met all of the eligibility criteria on telephone screening and underwent the procedure. Most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample. 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy. Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner. During an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (<1%) of 6388 participants in the usual care group were diagnosed with Barrett's oesophagus (absolute difference 18·3 per 1000 person-years [95% CI 14·8-21·8]; rate ratio adjusted for cluster randomisation 10·6 [95% CI 6·0-18·8], p<0·0001). Nine (<1%) of 6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage I oesophago-gastric cancer (n=5) in the intervention group, whereas no participants were diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer in the usual care group. Among 1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer. One patient had a detachment of the Cytosponge from the thread requiring endoscopic removal, and the most common side-effect was a sore throat in 63 (4%) of 1654 participants.
INTERPRETATION


In patients with gastro-oesophageal reflux, the offer of Cytosponge-TFF3 testing results in improved detection of Barrett's oesophagus. Cytosponge-TFF3 testing could also lead to the diagnosis of treatable dysplasia and early cancer. This strategy will lead to additional endoscopies with some false positive results.
FUNDING


Cancer Research UK, National Institute for Health Research, the UK National Health Service, Medtronic, and the Medical Research Council.",2020,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"['Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years', 'Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner', 'remaining 109 clinics, we identified 13\u2008657 eligible patients who were sent an introductory letter with 14 days to opt out', '6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study', 'Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation', ""1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer"", ""6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage"", '231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy', '109 socio-demographically diverse general practice clinics in England', 'patients with gastro-oesophageal reflux']","[""Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus"", 'standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group']","[""diagnosis of Barrett's oesophagus"", ""diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer"", ""diagnosed with Barrett's oesophagus""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",6834.0,0.132661,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Fitzgerald', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK. Electronic address: rcf29@mrc-cu.cam.ac.uk.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'di Pietro', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""O'Donovan"", 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maroni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Muldrew', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Debiram-Beecham', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Gehrung', 'Affiliation': 'Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Offman', 'Affiliation': ""Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Samuel G', 'Initials': 'SG', 'LastName': 'Smith', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Aigret', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Walter', 'Affiliation': 'The Primary Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rubin', 'Affiliation': 'Institute of Population Health Sciences, Newcastle University, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)31099-0']
1666,32745227,Osseous Integration of the Central Peg of an All-Polyethylene Glenoid With 3 Different Surgical Techniques.,"All-polyethylene glenoid components designed for osseous integration of the central peg can be placed with no graft (NG), autogenous bone graft (ABG), or demineralized bone matrix (DBM). The purpose of this study was to compare osseous integration with these 3 techniques. A randomized controlled trial was performed of 153 total shoulder arthroplasties using a pegged allpolyethylene glenoid component designed for osseous integration. Central peg treatment included NG, ABG, or DBM. The primary outcome was central peg osseous integration defined as bone presence between the central fins 1 year postoperatively. Central osseous integration was observed in 90% of cases treated with ABG, 68% of cases treated with DBM, and 68% of cases treated with NG (P=.022). Postoperative Wirth grading revealed radiolucency around the central peg (grade 1) in 2.4% of cases with ABG, 5.4% of cases with DBM, and 9.8% of cases with NG (P=.134). At short-term follow-up, osseous integration of the central peg of an all-polyethylene glenoid designed for bony growth between the central fins appears to be highest when treating the central peg with ABG compared with leaving the central peg untreated or using DBM. [Orthopedics. 2020;43(5):278-283.].",2020,"Postoperative Wirth grading revealed radiolucency around the central peg (grade 1) in 2.4% of cases with ABG, 5.4% of cases with DBM, and 9.8% of cases with NG (P=.134).",['153 total shoulder arthroplasties using a pegged allpolyethylene glenoid component designed for osseous integration'],['DBM'],"['NG, ABG, or DBM', 'Central osseous integration', 'central peg osseous integration defined as bone presence between the central fins 1 year postoperatively']","[{'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]","[{'cui': 'C0005962', 'cui_str': 'Bone matrix'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0439234', 'cui_str': 'year'}]",153.0,0.0247273,"Postoperative Wirth grading revealed radiolucency around the central peg (grade 1) in 2.4% of cases with ABG, 5.4% of cases with DBM, and 9.8% of cases with NG (P=.134).","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Denard', 'Affiliation': ''}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Gobezie', 'Affiliation': ''}, {'ForeName': 'Justin W', 'Initials': 'JW', 'LastName': 'Griffin', 'Affiliation': ''}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Romeo', 'Affiliation': ''}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Lederman', 'Affiliation': ''}]",Orthopedics,['10.3928/01477447-20200721-04']
1667,32745229,Gravity-Assisted Passive Flexion in Total Knee Arthroplasty Recovery.,"This study examined the use of gravity-assisted passive flexion (GAP-FLEX) for perioperative total knee arthroplasty (TKA) recovery. The main questions associated with this technique were: (1) Can GAP-FLEX improve patient recovery of range of motion after TKA? (2) Does GAP-FLEX reduce patient time and effort associated with therapy compared with continuous passive motion (CPM)? (3) Does GAP-FLEX reduce overall episodic care cost? A prospective, randomized multicenter study was conducted. Two senior surgeons used identical surgical approach, prosthesis, and postoperative management protocols. Patients consenting to the study were randomly assigned to either standard of care (CPM) or GAP-FLEX groups. Active flexion range of motion (ROM) was measured via goniometer with a primary endpoint established at 4 weeks after surgery. Secondary endpoints included pain and functional mobility. A total of 27 patients completed the study. Average ROM in the GAP-FLEX sample was 8.4° greater than the CPM sample (P=.009) at study endpoint. The GAP-FLEX patients achieved greater postoperative ROM within 2 days and maintained an improvement over CPM to study endpoint. Eighty-five percent (11 of 13) of GAP-FLEX patients achieved or surpassed their baseline ROM by study endpoint, compared with 50% (7 of 14) of CPM patients. These improvements occurred while requiring 90% less therapy time on device compared with the CPM patients. Patients did not report any statistically different pain levels but did exhibit higher functional mobility at endpoint (P=.026). [Orthopedics. 2020;43(5):e431-e437.].",2020,Average ROM in the GAP-FLEX sample was 8.4° greater than the CPM sample (P=.009) at study endpoint.,"['27 patients completed the study', 'Total Knee Arthroplasty Recovery', 'Patients consenting to the study']","['GAP-FLEX', 'gravity-assisted passive flexion (GAP-FLEX', 'Gravity-Assisted Passive Flexion', 'standard of care (CPM) or GAP-FLEX groups']","['Average ROM', 'pain and functional mobility', 'pain levels', 'Active flexion range of motion (ROM', 'functional mobility', 'postoperative ROM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",2.0,0.0415538,Average ROM in the GAP-FLEX sample was 8.4° greater than the CPM sample (P=.009) at study endpoint.,"[{'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Buttacavoli', 'Affiliation': ''}]",Orthopedics,['10.3928/01477447-20200721-09']
1668,32745734,Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial.,"BACKGROUND


Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system.
TRIAL DESIGN


OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
CONCLUSIONS


OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.",2020,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","['480 event-free patients will undergo repeat AMCE', 'patients receiving different antiplatelet therapy regimens after stent implantation', 'patients treated with antiplatelet agents after percutaneous coronary intervention (PCI']","['aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo', 'open-label aspirin', 'clopidogrel', 'placebo']","['incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding', 'gastrointestinal erosions, ulceration or bleeding']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1261962', 'cui_str': 'Gastrointestinal erosion'}]",,0.524049,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Endoscopy, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Heyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.06.004']
1669,32745768,Oxylipin regulation by phenolic compounds from coffee beverage: Positive outcomes from a randomized controlled trial in healthy adults and macrophage derived foam cells.,"Oxylipins are considered biomarkers related to cardiovascular diseases (CVDs). They are generated in vivo via the oxygenation of polyunsaturated fatty acids as a result of oxidative stress and inflammation. Oxylipins are involved in vascular functions and are produced during foam cell formation in atherogenesis. Additionally, the consumption coffee is associated with the regulation on a particular oxylipin group, the F 2t -isoprostanes (F 2t -IsoPs). This function has been attributed to the chlorogenic acids (CGAs) from the coffee beverage. Considering the anti-inflammatory and antioxidant properties of CGAs, we evaluated the effects of two types of coffee that provided 787 mg CGAs/day (Coffee A) and 407 mg CGAs/day (Coffee B) by reducing 35 selected oxylipins in healthy subjects. Furthermore, we assessed the effect of CGAs on the cellular proatherogenic response in foam cells by using an oxidized LDL (oxLDL)-macrophage interaction model. After eight weeks of coffee consumption, the contents of 12 urine oxylipins were reduced. However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs. Neither of the two coffees reduced the levels of oxLDL. Moreover, the in vitro oxylipin induction by oxLDL on foam cells was ameliorated by phenolic acids and CGAs, including the inhibition of IsoPs and PGs by caffeoylquinic and dicaffeoylquinic acids, respectively, while the phenolic acids maintained both antioxidant and anti-inflammatory activities. These findings suggest that coffee antioxidants are strong regulators of oxylipins related to CVDs. The clinical trial was registered on the International Clinical Trials Registry Platform, WHO primary registry (RPCEC00000168).",2020,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","['healthy adults and macrophage derived foam cells', 'healthy subjects']",['CGAs'],"['levels of oxLDL', 'IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0016390', 'cui_str': 'Foam cell'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0055633', 'cui_str': 'Chromogranin A'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0997851', 'cui_str': 'Geodia'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0588372,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","[{'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Lara-Guzmán', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Medina', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Álvarez', 'Affiliation': 'Grupo de Investigación en Sustancias Bioactivas, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Oger', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Durand', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Galano', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Zuluaga', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil-Izquierdo', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain. Electronic address: angelgil@cebas.csic.es.'}, {'ForeName': 'Katalina', 'Initials': 'K', 'LastName': 'Muñoz-Durango', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia. Electronic address: kmunoz@serviciosnutresa.com.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.07.020']
1670,32723736,Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network.,"INTRODUCTION


Primary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.
METHODS AND ANALYSIS


This cluster randomised effectiveness trial includes 24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings (PROS) practice-based research network. To date, practices have been randomised (nine to intervention and nine to usual care). Intervention Ped/NPs have been trained in MI, behavioural therapy, billing/coding for weight management and study procedures. Usual care Ped/NPs received training in billing/coding and study procedures only. Children 3- 11 years old with BMI  > the 85th percentile were identified via electronic health records (EHRs). Parents from intervention practices have been recruited and enrolled. Over about 2 years, these parents are offered approximately 10 MI-based counselling sessions (about four in person sessions with their child's Ped/NP and up to six telephonic sessions with a trained RD). The primary outcome is change in child BMI (defined as per cent from median BMI for age and sex) over the study period. The primary comparison is between eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices. Data sources will include EHRs, billing records, surveys and counselling call notes.
ETHICS AND DISSEMINATION


Institutional Review Board approval was obtained from the AAP. All Ped/NPs provided written informed consent, and intervention group parents provided consent and Health Insurance Portability and Accountability Act (HIPAA) authorisation. Findings will be disseminated through peer-reviewed publications, conference presentations and appropriate AAP channels.
TRIAL REGISTRATION NUMBER


NCT03177148; Pre-results.",2020,"The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.
","['3- 11 years old with BMI  > the 85th percentile were identified via electronic health records (EHRs', 'eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices', 'Children', '24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings']","['paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI', 'primary care-based MI counselling intervention']","['child body mass index (BMI', 'change in child BMI']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027341', 'cui_str': 'Nail-patella syndrome'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0786239,"The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.
","[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Wright', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA mewright@uic.edu.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Delacroix', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kendrin R', 'Initials': 'KR', 'LastName': 'Sonneville', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Considine', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Proctor', 'Affiliation': ""Physician's Computer Company, Winooski, Vermont, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Steffes', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Shone', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Woo', 'Affiliation': 'Department of Paediatrics, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Vaughan', 'Affiliation': 'Department of Hospital Biostatistics, The Rockefeller University, New york City, New york, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Grundmeier', 'Affiliation': ""Department of Paediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': 'Pediatric Research in Office Settings, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Melissa S', 'Initials': 'MS', 'LastName': 'Stockwell', 'Affiliation': 'Pediatric Research in Office Settings, American Academy of Pediatrics, Itasca, Illinois, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2019-035720']
1671,32723752,Correction: Effects of home-based cardiac exercise rehabilitation with remote electrocardiogram monitoring in patients with chronic heart failure: a study protocol for a randomised controlled trial.,,2020,,['patients with chronic heart failure'],['home-based cardiac exercise rehabilitation with remote electrocardiogram monitoring'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",[],,0.0542666,,[],BMJ open,['10.1136/bmjopen-2018-023923corr1']
1672,32723753,Correction: Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction).,,2020,,['people with schizophrenia and related disorders'],"['gradual antipsychotic reduction and discontinuation', 'Correction']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",[],,0.0733776,,[],BMJ open,['10.1136/bmjopen-2019-030912corr1']
1673,32729696,[Impact of psychoeducation on compliance of inpatients with first episode psychosis].,"OBJECTIVE


To assess the impact of brief group inpatient psychoeducation interventions on compliance of patients with first episode psychosis (FEP) and emergency hospitalization.
MATERIAL AND METHODS


One hundred and fifty-eight patients of treatment group and 79 patients of the control group were enrolled into the study. All patients were hospitalized emergently due to psychotic condition. Patients in treatment group had group psychoeducation sessions (5 sessions), patients in the control group received basic treatment only. Before discharge from the hospital, patients were accessed with PANSS, CGI-S, CGI-I and «Medication compliance scale».
RESULTS


Patient in treatment group showed significantly better results than the control group in medication compliance scale assessment ( p <0.001). The rate of readmissions was significantly higher in the control group than in the psychoeducation group ( p =0.02).
CONCLUSION


Brief psychoeducation for inpatients with FEP and emergency hospitalizations has beneficial effect on patients' compliance.",2020,"The rate of readmissions was significantly higher in the control group than in the psychoeducation group ( p =0.02).
","['All patients were hospitalized emergently due to psychotic condition', 'patients with first episode psychosis (FEP) and emergency hospitalization', 'One hundred and fifty-eight patients of treatment group and 79 patients of the control group were enrolled into the study', 'inpatients with first episode psychosis', 'inpatients with FEP and emergency hospitalizations']","['brief group inpatient psychoeducation interventions', 'psychoeducation']","['medication compliance scale assessment', 'I and «Medication compliance scale', 'rate of readmissions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",158.0,0.0147329,"The rate of readmissions was significantly higher in the control group than in the psychoeducation group ( p =0.02).
","[{'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Karpenko', 'Affiliation': 'Alekseev Psychiatric Clinical Hospital No. 1, Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012006292']
1674,32734606,A Time-to-Event Model Relating Integrated Craving to Risk of Smoking Relapse Across Different Nicotine Replacement Therapy Formulations.,"Smoking increases the risk of cancer and other diseases, causing an estimated 7 million deaths per year. Nicotine replacement therapy (NRT) reduces craving for smoking, therefore, increasing an individual's probability to remain abstinent. In this work, we for the first time quantitatively described the relationship between craving and smoking abstinence, using retrospectively collected data from 19 studies, including 3 NRT formulations (inhaler, mouth spray, and patch) and a combination of inhaler and patch. Smokers motivated to quit were included in the NRT or placebo arms. Integrated craving (i.e., craving over a period of time) was assessed with 4-category, 5-category, or 100-mm visual analogue scale. The bounded integer model was used to assess latent craving from all scales. A time-to-event model linked predicted integrated craving to the hazard of smoking relapse. Available data included 9,323 adult subjects, observed for 3 weeks up to 2 years. At the study end, 9% (11% for NRT and 5% for placebo), on average, remained abstinent according to the protocol definition. A Gompertz-Makeham hazard best described the data, with a hazard of smoking relapse decreasing over time. Latent integrated craving was positively related to the hazard of smoking relapse, through a sigmoidal maximum effect function. For the same craving, being on NRT was found to reduce the hazard of relapse by an additional 30% compared with placebo. This work confirmed that low craving is associated with a high probability of remaining smoking abstinent and that NRT, in addition to reducing craving, increases the probability of remaining smoking abstinent.",2020,"For the same craving, being on NRT was found to reduce the hazard of relapse by an additional 30% compared to placebo.","['9,323 adult subjects, observed for 3 weeks up to 2 years']","['nicotine replacement therapy formulations', 'placebo', 'Nicotine replacement therapy (NRT']","['Integrated craving (i.e. craving', '4-category, 5-category or 100-mm visual analogue scales (VAS', 'Latent integrated craving', 'hazard of relapse', 'risk of cancer and other diseases']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",9323.0,0.0388632,"For the same craving, being on NRT was found to reduce the hazard of relapse by an additional 30% compared to placebo.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Germovsek', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hansson', 'Affiliation': 'McNeil AB, Helsingborg, Sweden.'}, {'ForeName': 'Mats O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Westin', 'Affiliation': 'McNeil AB, Helsingborg, Sweden.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Soons', 'Affiliation': 'Janssen R&D - A Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen R&D - A Division of Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Kjellsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2000']
1675,32734638,Surgiflo ®  may have a potential impact on the healing process in cricotracheal resection anastomosis.,"OBJECTIVES


To evaluate the role of thrombin-based haemostatic agent Surgiflo ®  (Ethicon) in improving the outcome of cricotracheal resection anastomosis.
DESIGN


Randomised controlled clinical trial.
SETTING


Otorhinolaryngology Department, Mansoura University Hospitals, Egypt.
PARTICIPANTS


This study included 55 patients with grade III and IV subglottic and/or cervical tracheal stenosis, who underwent cricotracheal resection anastomosis. Patients were randomly assigned into two groups: Surgiflo group (n = 20) and control group (n = 35). In Surgiflo patients, Surgiflo ®  was applied at the end of surgery over the whole operative field including the line of airway anastomosis with the purpose of adequate haemostasis and enhancing healing of the anastomosis.
MAIN OUTCOME MEASURES


The success rate and the incidence of complications in both groups were compared.
RESULTS


At the end of treatment, decannulation rate was 95% (19/20) in the Surgiflo groups and 82.8% (29/35) in the control group. The overall incidence of complications was significantly lower in the Surgiflo group (P = .021). Need for further surgical airway interventions in the form of repeated dilatation, granulation tissue removal or performing a tracheotomy was reported in 22.9% (8/35) of control group patients, in comparison with 5% (1/20) in Surgiflo group.
CONCLUSION


Direct Surgiflo ®  application in the operative field enhances the anastomotic healing, decreases the incidence of anastomotic complications and subsequently improves the outcome. It can be recommended as an adjuvant to surgery in patients undergoing cricotracheal resection anastomosis.",2020,The overall incidence of complications was significantly lower in the Surgiflo group (p=0.021).,"['patients undergoing cricotracheal resection anastomosis', '55 patients with grade III and IV subglottic and/or cervical tracheal stenosis, who underwent', 'Otorhinolaryngology Department, Mansoura University Hospitals, Egypt', 'cricotracheal resection anastomosis']","['thrombin based hemostatic agent Surgiflo® (Ethicon, Somerville, USA', 'cricotracheal resection anastomosis']","['success rate and the incidence of complications', 'incidence of anastomotic complications', 'overall incidence of complications', 'anastomotic healing', 'decannulation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0040583', 'cui_str': 'Stenosis of trachea'}, {'cui': 'C0587514', 'cui_str': 'Ear, nose and throat department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019120', 'cui_str': 'Hemostatic agent'}, {'cui': 'C4058557', 'cui_str': 'Surgiflo'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1141928', 'cui_str': 'Anastomotic complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0178148', 'cui_str': 'Removal of tracheostomy tube'}]",55.0,0.0231968,The overall incidence of complications was significantly lower in the Surgiflo group (p=0.021).,"[{'ForeName': 'Ahmed Musaad Abd', 'Initials': 'AMA', 'LastName': 'El-Fattah', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hisham Atef', 'Initials': 'HA', 'LastName': 'Ebada', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tawfik', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13614']
1676,32731118,"Long-term safety and efficacy of brivaracetam in adults with focal seizures: Results from an open-label, multinational, follow-up trial.","BACKGROUND


This long-term follow-up (LTFU) trial was conducted to evaluate the long-term safety and tolerability of brivaracetam (BRV) at individualized doses (maximum of 200 mg/day) in patients with focal seizures. The secondary objective was to evaluate the efficacy of BRV over time.
METHODS


Two Phase III, randomized, double-blind, historical-controlled conversion-to-monotherapy trials (N01276: NCT00698581; N01306: NCT00699283) were conducted in patients aged ≥16 years with uncontrolled focal seizures. Patients who completed either of these core trials or who met a protocol-defined exit criterion could enter this LTFU trial (N01315; NCT00761774). Patients entered LTFU at a recommended BRV dose of 100 mg/day, with flexible dosing of 50-200 mg/day, as monotherapy or adjunctive therapy; additional AEDs could be prescribed and adapted in dose if clinically indicated. Safety variables included treatment-emergent adverse events (TEAEs). Efficacy variables included duration of continuous monotherapy, reduction in focal seizure frequency and seizure freedom. Safety and efficacy variables were assessed for all patients in the safety set or efficacy set, respectively, regardless of BRV treatment regimen. In addition, a post hoc subgroup analysis was conducted for patients who completed the BRV monotherapy period in either core trial, and entered the LTFU on BRV monotherapy. For this subgroup, TEAEs were summarized by 3-month time intervals over the first 12 months of LTFU.
RESULTS


108 patients were enrolled in the LTFU trial between November 2008 and February 2010. 79 (73.1 %) patients discontinued the LTFU trial, most commonly due to lack of efficacy [37 (34.3 %)] and adverse events [16 (14.8 %)]. At core trial baseline, patients had a median of 6.3 focal seizures/28 days and 53 (49.1 %) had failed ≥5 previous lifetime AEDs. During LTFU, 70 (64.8 %) patients had ≥12 months and 56 (51.9 %) patients had ≥24 months of BRV treatment. TEAEs were reported by 98 (90.7 %) patients; most commonly (≥15 % of patients) convulsion (17.6 %), nasopharyngitis (17.6 %), depression (16.7 %) and fatigue (15.7 %). Median percent reduction from baseline in focal seizure frequency/28 days was 56.8 %. Among 86 patients who completed at least 6 months of treatment, 29 (33.7 %) patients were seizure-free for ≥6 months and 22 (25.6 %) were seizure-free for ≥12 months. 50/108 patients were included in the BRV monotherapy subgroup; 33/50 (66.0 %) patients reported a TEAE in the core trials, while 26/50 (52.0 %), 15/37 (40.5 %), 14/33 (42.4 %) and 9/27 (33.3 %) patients reported any TEAE during LTFU months 1-3, 4-6, 7-9 and 10-12, respectively. In the BRV monotherapy subgroup, the most common TEAEs (≥5% of patients) during LTFU months 1-3 were fatigue [3/50 (6.0 %)] and dizziness [3/50 (6.0 %)].
INTERPRETATION


Results from the LTFU trial support the long-term safety of BRV at individualized doses of up to 200 mg/day as a well-tolerated, and effective treatment for patients with focal seizures. Efficacy analyses indicate that seizure reductions with brivaracetam were generally maintained over time.",2020,"TEAEs were reported by 98 (90.7 %) patients; most commonly (≥15 % of patients) convulsion (17.6 %), nasopharyngitis (17.6 %), depression (16.7 %) and fatigue (15.7 %).","['patients with focal seizures', '86 patients who completed at least 6 months of treatment, 29 (33.7 %) patients were seizure-free for ≥6 months and 22 (25.6 %) were seizure-free for ≥12 months', 'patients aged ≥16 years with uncontrolled focal seizures', 'adults with focal seizures', '108 patients were enrolled in the LTFU trial between November 2008 and February 2010']","['brivaracetam', 'brivaracetam (BRV', 'LTFU']","['dizziness', 'treatment-emergent adverse events (TEAEs', 'fatigue', 'Safety and efficacy variables', 'focal seizure frequency and seizure freedom', 'adverse events', 'nasopharyngitis', 'depression', 'seizure reductions with brivaracetam']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}]",108.0,0.524516,"TEAEs were reported by 98 (90.7 %) patients; most commonly (≥15 % of patients) convulsion (17.6 %), nasopharyngitis (17.6 %), depression (16.7 %) and fatigue (15.7 %).","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Arnold', 'Affiliation': 'Department of Neurology, Schön Klinik Vogtareuth, Krankenhausstraße 20, 83569, Vogtareuth, Germany. Electronic address: SArnold@Schoen-Kliniken.de.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Allée de la Recherche, 60, B - 1070 Brussels, Belgium. Electronic address: Cedric.Laloyaux@ucb.com.'}, {'ForeName': 'Anne-Liv', 'Initials': 'AL', 'LastName': 'Schulz', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Strasse 10, 40789 Monheim am Rhein, Germany. Electronic address: Anne-Liv.Schulz@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Sami.Elmoufti@ucb.com.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Yates', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Stephen.Yates@ucb.com.'}, {'ForeName': 'Toufic', 'Initials': 'T', 'LastName': 'Fakhoury', 'Affiliation': 'St. Joseph Health System, 1401 Harrodsburg Road, Suite B-280, Lexington, KY 40504, USA. Electronic address: TouficFakhoury@catholichealth.net.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106404']
1677,32731249,Early Anticoagulation or Antiplatelet Therapy Is Critical in Craniocervical Artery Dissection: Results from the COMPASS Registry.,"INTRODUCTION


Craniocervical artery dissection (CeAD) is a leading cause of stroke in the young patient population. Recent studies reported a low rate of major adverse cardiac events (MACEs) in patients with CeAD, with no significant difference between patients randomized to anticoagulation or antiplatelet therapy.
OBJECTIVE


To compare the effectiveness of anticoagulation and antiplatelet therapy in patients with CeAD.
METHODS


All CeAD patients from 2015 to 2017 were consecutively identified by an electronic medical record-based application and enrolled in this prospective longitudinal registry. CeAD was confirmed by imaging and graded using the Denver scale for blunt cerebrovascular injury. Patients were followed for 12 months for MACE defined as stroke, transient ischemic attack (TIA), or death.
RESULTS


The cohort included 111 CeAD patients (age 53 ± 15.9 years, 56% Caucasian, 50% female). CeAD was detected by magnetic resonance (5%), computed tomography (88%), or catheter angiography (7%). CeAD was noted in the carotid (59%), vertebral (39%), and basilar (2%) arteries, 82% of which were extracranial dissections. CeAD was classified as grade I, II, III, and IV in 16, 33, 19, and 32%, respectively. A total of 40% of dissections were due to known trauma. A predisposing factor was noted in the majority (78%) of patients, including violent sneezing (21%), carrying a heavy load (19%), sports/recreational activity (11%), chiropractic manipulation (9%), abrupt/prolonged rotation of head (9%), and prolonged phone use (9%). At presentation, 41% had a stroke, 5% had TIA, 39% had headache, and 36% were asymptomatic. Favorable outcome defined as a modified Rankin Scale score of 0-2 was noted in 68% at 3 months and 71% at 12 months. The rate of MACEs at 3 and 12 months was 11 and 14%, respectively, with more events observed in patients who were not receiving anticoagulation/antiplatelet therapy due to contraindications (p = 0.008).
CONCLUSIONS


We report diagnostic characteristics, as well as short- and long-term outcomes of CeAD. A high MACE rate was observed within the first 2 weeks of CeAD diagnosis, notably in patients not initiated on anticoagulation or antiplatelet therapy.",2020,Favorable outcome defined as a modified Rankin Scale score of 0-2 was noted in 68% at 3 months and 71% at 12 months.,"['young patient population', 'Craniocervical Artery Dissection', 'patients with CeAD', 'patients with CeAD.\nMETHODS\n\n\nAll CeAD patients from 2015 to 2017 were consecutively identified by an electronic medical record-based application and enrolled in this prospective longitudinal registry', '111 CeAD patients (age 53 ± 15.9 years, 56% Caucasian, 50% female']",['Craniocervical artery dissection (CeAD'],"['headache', 'sports/recreational activity', 'stroke, transient ischemic attack (TIA), or death', 'modified Rankin Scale score of 0-2', 'chiropractic manipulation', 'MACE rate', 'CeAD', 'violent sneezing', 'rate of MACEs']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002949', 'cui_str': 'Dissection of artery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002949', 'cui_str': 'Dissection of artery'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600577', 'cui_str': 'Chiropractic manipulation'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0002949', 'cui_str': 'Dissection of artery'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",111.0,0.0650806,Favorable outcome defined as a modified Rankin Scale score of 0-2 was noted in 68% at 3 months and 71% at 12 months.,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Rosati', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vezzetti', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Kolby T', 'Initials': 'KT', 'LastName': 'Redd', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Brittiny', 'Initials': 'B', 'LastName': 'McMillian', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Giamberardino', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Nishanth', 'Initials': 'N', 'LastName': 'Kodumuri', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Ravish', 'Initials': 'R', 'LastName': 'Kothari', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Anil V', 'Initials': 'AV', 'LastName': 'Yallapragada', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA, souvik.sen@uscmed.sc.edu.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000509415']
1678,32737091,Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study.,"INTRODUCTION


Observational and interventional studies indicate that the type of anaesthesia may be associated with the postprocedural neurological function in patients with anterior circulation acute ischaemic stroke undergoing endovascular treatment. Patients with acute posterior circulation ischaemic stroke may experience different physiological changes and result in severe neurological outcome. However, the effect of the type of anaesthesia on postprocedure neurological function remained unclear in this population.
METHODS AND ANALYSIS


This is an exploratory randomised controlled trial that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Patients with acute posterior circulation ischaemic stroke and deemed suitable for emergency endovascular recanalisation will be recruited in this trial. Eighty-four patients will be randomised to receive either general anaesthesia or conscious sedation with 1:1 allocation ratio. The primary endpoint is the 90-day modified Rankin Scale.
ETHICS AND DISSEMINATION


The study has been reviewed by and approved by Ethics Committee of Beijing Tiantan Hospital of Capital Medical University (KY2017-074-02). If the results are positive, the study will indicate whether the type of anaesthesia affects neurological outcome after endovascular treatment of posterior stroke. The findings of the study will be published in peer-reviewed journals and presented at national or international conferences.
TRIAL REGISTRATION NUMBER


NCT03317535.",2020,"If the results are positive, the study will indicate whether the type of anaesthesia affects neurological outcome after endovascular treatment of posterior stroke.","['Patients with acute posterior circulation ischaemic stroke', 'Beijing Tiantan Hospital of Capital Medical University (KY2017-074-02', 'patients with anterior circulation acute ischaemic stroke undergoing endovascular treatment', 'acute ischaemic stroke at posterior circulation (CANVAS II', 'Beijing Tiantan Hospital, Capital Medical University']","['ANaesthesia', 'general anaesthesia or conscious sedation with 1:1 allocation ratio', 'emergency endovascular recanalisation']","['90-day modified Rankin Scale', 'postprocedure neurological function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",84.0,0.174259,"If the results are positive, the study will indicate whether the type of anaesthesia affects neurological outcome after endovascular treatment of posterior stroke.","[{'ForeName': 'Fa', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Youxuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiuheng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Minyu', 'Initials': 'M', 'LastName': 'Jian', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongrong', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Interventional Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China florapym766@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-036358']
1679,32737097,Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial.,"INTRODUCTION


Informal caregivers play a major role in the support and maintenance of community patients with severe psychiatric disorders. A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.
METHODS AND ANALYSIS


This randomised controlled trial aims to compare the efficacy of using Ensemble in improving informal caregivers' psychological health states and the ability to play an active role in their situations with that of support as usual. Improvements on the psychological health global index will be measured three times (T0-pre, T1-post and T3 2 months follow) with standardised questionnaires (the Global Severity Index of Brief Inventory Symptoms, the Life Orientation Test-Revised, the 36-item Medical Outcome Study Short-Form Health Survey and the French Zarit Burden Interview). Differences between groups in post-test and pretest values will be examined using an analysis of covariance for each outcome variable. The severity of illness measured by the Social and Occupational Functioning Assessment Scale will also be collected at T0 and T2 to compare eventual patient improvements. At the end of the programme, the experiences of the 20 patients participating in the Ensemble programme will be evaluated qualitatively.
ETHICS AND DISSEMINATION


The research protocol received full authorisation from the Human Research Ethics Committee of the Vaud state, Switzerland. The principal paper will concern the results of the experimental design used to test the Ensemble programme. The research team will prioritise open access publications.
TRIAL REGISTRATION NUMBER


NCT04020497.",2020,"A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.
","['informal caregivers of psychiatric adult patients', 'community patients with severe psychiatric disorders', '20 patients participating in the Ensemble programme will be evaluated qualitatively']",[],"['severity of illness measured by the Social and Occupational Functioning Assessment Scale', 'Global Severity Index of Brief Inventory Symptoms, the Life Orientation Test-Revised, the 36-item Medical Outcome Study Short-Form Health Survey and the French Zarit Burden Interview', 'psychological health state and optimism', 'psychological health global index']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582640', 'cui_str': 'Life orientation test'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",20.0,0.0922263,"A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.
","[{'ForeName': 'Shyhrete', 'Initials': 'S', 'LastName': 'Rexhaj', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland s.rexhaj@ecolelasource.ch.'}, {'ForeName': 'Shadya', 'Initials': 'S', 'LastName': 'Monteiro', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Golay', 'Affiliation': 'Community Psychiatry Service, Department of Psychiatry, Lausanne, CHUV, Lausanne, VD, Switzerland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Coloni-Terrapon', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wenger', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Favrod', 'Affiliation': 'La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2020-038781']
1680,32737249,Correction: Cost-utility analysis of learning and coping versus standard education in cardiac rehabilitation: a randomised controlled trial with 3 years of follow-up.,,2020,,['cardiac rehabilitation'],['learning and coping versus standard education'],[],"[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.11373,,[],Open heart,['10.1136/openhrt-2019-001184corr1']
1681,32739319,Effect of baseline sarcopenia on adjuvant treatment for D2 dissected gastric cancer: Analysis of the ARTIST phase III trial.,"BACKGROUND AND PURPOSE


This study evaluated the clinical significance of preoperative sarcopenia according to adjuvant concurrent chemo-radiotherapy (XP-RT) or chemotherapy alone (XP) in the D2 dissected gastric cancer patient cohort of the ARTIST trial.
MATERIALS AND METHODS


Skeletal muscles at the L3 vertebra level from preoperative computed tomography images among the ARTIST trial participants were measured using validated in-house software. Skeletal muscle index (SMI) was defined as the measured skeletal muscle area divided by the square of the height, and sarcopenia was defined according to the Korean-specific cutoff, i.e. L3 SMI ≤ 49 cm 2 /m 2  for men and ≤31 cm 2 /m 2  for women.
RESULTS


Among the 440 patients in whom we were able to evaluate L3 SMI, 75 (17.0%) met the definition for preoperative sarcopenia. No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm. In the subgroup of patients without preoperative sarcopenia, recurrence was significantly lower in the XP-RT arm than that in the XP arm (p = 0.02). Recurrence-free survival (RFS) was also significantly higher in the XP-RT arm (p = 0.02, hazard ratio 0.633, 95% confidence interval 0.433-0.926) in this subgroup. In the multivariate analysis, and after adjusting for significant prognostic factors, the superior outcome of XP-RT arm regarding RFS was maintained in the subgroup of the patients without preoperative sarcopenia.
CONCLUSIONS


Superior clinical outcomes of adjuvant XP-RT over XP were only observed in patients without preoperative sarcopenia.",2020,No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm.,"['Skeletal muscles at the L3 vertebra level from preoperative computed tomography images among the ARTIST trial participants were measured using validated in-house software', '440 patients in whom we were able to evaluate L3 SMI, 75 (17.0%) met the definition for preoperative sarcopenia', 'D2 dissected gastric cancer', 'D2 dissected gastric cancer patient cohort of the ARTIST trial']","['adjuvant concurrent chemo-radiotherapy (XP-RT) or chemotherapy alone (XP', 'baseline sarcopenia']","['Skeletal muscle index (SMI', 'preoperative sarcopenia, recurrence', 'Recurrence-free survival (RFS']","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0223522', 'cui_str': 'Bone structure of L3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0402043', 'cui_str': 'Artist'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",440.0,0.0407846,No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm.,"[{'ForeName': 'Jeong Il', 'Initials': 'JI', 'LastName': 'Yu', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: jeongil.yu@samsung.com.'}, {'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Tae', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Yong', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Sung', 'Initials': 'TS', 'LastName': 'Sohn', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Gew', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Moon', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung-Mee', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heewon', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Heerim', 'Initials': 'H', 'LastName': 'Nam', 'Affiliation': 'Department of Radiation Oncology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: dh8.lim@samsung.com.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.07.043']
1682,32739652,"Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.","BACKGROUND


Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear.
STUDY DESIGN


The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks (""bi-risk""). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization.
CONCLUSIONS


OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.",2020,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","['7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS', 'patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention', 'acute coronary syndrome patients with both high bleeding and ischemic risk', 'patients at special risk', 'ACS patients with both high bleeding and high ischemic risks (""bi-risk']","['clopidogrel alone versus clopidogrel plus aspirin', 'aspirin and a P2Y12 inhibitor', 'aspirin monotherapy', 'aspirin and clopidogrel', 'clopidogrel monotherapy or aspirin plus clopidogrel', 'placebo']","['major adverse cardiac and cerebral events', 'composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization', 'bleeding events', 'Bleeding Academic Research Consortium type 2, 3, or 5 bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",7700.0,0.0625651,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shubing', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital of Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Nanjing First Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.07.005']
1683,32740179,Skin-to-Skin Care Is a Safe and Effective Comfort Measure for Infants Before and After Neonatal Cardiac Surgery.,"OBJECTIVES


To determine the effect of skin-to-skin care on stress, pain, behavioral organization, and physiologic stability of infants with critical congenital heart disease before and after neonatal cardiac surgery.
DESIGN


A baseline response-paired design was used, with infants acting as their own controls before, during, and after skin-to-skin care at two distinct time points: once in the preoperative period (T1) and once in the postoperative period (T2).
SETTING


Cardiac ICU and step-down unit in a large metropolitan freestanding children's hospital.
SUBJECTS


Convenience sample of 30 infants admitted preoperatively for critical congenital heart disease.
INTERVENTIONS


Eligible infants were placed into skin-to-skin care for 1 hour with their biological mothers once each at T1 and T2.
MEASUREMENTS AND MAIN RESULTS


Measurements of stress (salivary cortisol), pain and behavior state (COMFORT scale), and physiologic stability (vital signs) were assessed immediately before skin-to-skin care, 30 minutes into skin-to-skin care, and 30 minutes after skin-to-skin care ended.At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline. At T1, infants also had significantly reduced heart rate (p = 0.002) and respiratory rate (p < 0.0001) and increased systolic blood pressure (p = 0.033) during skin-to-skin care. At both T1 and T2, infant cortisol remained stable and unchanged from pre-skin-to-skin care to during skin-to-skin care (p = 0.096 and p = 0.356, respectively), and significantly increased from during skin-to-skin care to post-skin-to-skin care (p = 0.001 and p = 0.023, respectively). Exploratory analysis revealed differences in cortisol reactivity for infants with higher baseline cortisol (> 0.3 μg/dL) versus lower (≤ 0.3 μg/dL) prior to skin-to-skin care. Infants with higher baseline cortisol at T2 experienced significantly reduced cortisol during skin-to-skin care (p = 0.025). No significant differences in demographics or baseline variables were found between infants in either group.
CONCLUSIONS


Skin-to-skin care is a low-cost, low-risk intervention that promotes comfort and supports physiologic stability in infants before and after neonatal cardiac surgery.",2020,"At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline.","['infants before and after neonatal cardiac surgery', 'infants with critical congenital heart disease before and after neonatal cardiac surgery', 'Infants Before and After Neonatal Cardiac Surgery', 'Convenience sample of 30 infants admitted preoperatively for critical congenital heart disease', ""large metropolitan freestanding children's hospital""]","['skin-to-skin care', 'Skin-to-Skin Care']","['stress, pain, behavioral organization, and physiologic stability', 'Measurements of stress (salivary cortisol), pain and behavior state (COMFORT scale), and physiologic stability (vital signs', 'heart rate', 'systolic blood pressure', 'respiratory rate', 'cortisol reactivity', 'infant pain scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",30.0,0.0256545,"At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Lisanti', 'Affiliation': ""Nursing and Clinical Care Services, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Demianczyk', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Costarino', 'Affiliation': ""Cardiac Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Vogiatzi', 'Affiliation': ""Adrenal and Puberty Center, Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Laboratory of Innovative & Translational Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Quinn', 'Affiliation': 'Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Chittams', 'Affiliation': 'Biostatistics Analysis Core, Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Medoff-Cooper', 'Affiliation': ""Nursing and Clinical Care Services, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002493']
1684,32740180,Investigating the Efficacy of Hydrocolloid Dressing for Preventing Nasotracheal Tube-Related Pressure Injury in the PICU.,"OBJECTIVES


To investigate the efficacy of hydrocolloid dressing in reducing the occurrence rate and severity of nasotracheal tube-related pressure injury.
DESIGN


Randomized controlled trial.
SETTING


A PICU in a tertiary medical center in southern China.
PATIENTS


Pediatric patients received invasive mechanical ventilation via nasotracheal tubes.
INTERVENTIONS


The hydrocolloid dressing was cut into an optimal square size, which should cover the area from the nasal columella to the ala.
MEASUREMENTS AND MAIN RESULTS


Eligible participants were randomly allocated to the control group and the experimental group. The participants in the experimental group received hydrocolloid dressing to protect nasal skin from the beginning of nasotracheal intubation, while the participants in the control group received the current care procedure (without hydrocolloid dressing) unless pressure injuries occurred. The hydrocolloid dressing was changed daily to assess the nasal skin. The pressure injury staging system that was redefined and updated by the National Pressure Ulcer Advisory Panel in 2016 was used. The mean duration of nasotracheal intubation was 150.10 ± 117.09 hours in the experimental group and 161.75 ± 120.72 hours in the control group. Forty-five participants had nasotracheal tube-related pressure injuries in control group, whereas 26 patients had in experimental group (72.6% vs 43.3%; absolute difference, 29.3%, 95% CI, 12.5-46%; p = 0.001). The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
CONCLUSIONS


Hydrocolloid dressing can not only reduce the occurrence rate of nasotracheal tube-related pressure injury in the child with long-term nasotracheal intubation but also improve the endurance of the nasal skin significantly.",2020,"The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
","['A PICU in a tertiary medical center in southern China', 'Pediatric patients received']","['invasive mechanical ventilation via nasotracheal tubes', 'hydrocolloid dressing', 'current care procedure (without hydrocolloid dressing', 'Hydrocolloid dressing', 'Hydrocolloid Dressing']","['occurrence rate', 'mean duration of nasotracheal intubation', 'nasal skin', 'nasotracheal tube-related pressure injuries', 'median survival times of the nasal skin integrity']","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0122734', 'cui_str': 'Hydrocolloid dressing'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C1286235', 'cui_str': 'Integrity of skin'}]",,0.0311669,"The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jinlu', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jine', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yanxuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Nursing, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002494']
1685,32741642,"The effect of a single 75 mg preoperative dose of pregabalin on postoperative pain in rhinoplasty: A double-blinded, placebo-controlled randomized clinical trial.","The goal of this study was to evaluate the effect of a single preoperative dose of 75 mg of pregabalin on postoperative pain in rhinoplasty. Volunteers with a physical status of ASA I were included in our study after informed written consent. This was a randomized, double-blinded, placebo-controlled clinical trial. All pregabalin and placebo capsules were given to patients orally 1 h prior to surgery. A standard open rhinoplasty procedure was performed on all patients. All patients underwent the same general anesthesia and postoperative analgesic protocol, with the only difference between the two studied groups being the use of a single dose of pregabalin prior to surgery. Finally, pain intensity was measured at 2, 4, 6, 12, and 24 h after surgery, using a horizontal visual analogue scale (VAS), and was analyzed statistically. 128 volunteers - 33 men (25.8%) and 95 women (74.2%) - with a mean age of 26.23 ± 7.16 were included in this study. Pain intensity scores were consistently lower in patients who received pregabalin preoperatively (p = 0.002); however, the incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation showed no differences between the two study groups (p > 0.05). In conclusion, the administration of pregabalin should be added to the perioperative protocol whenever appropriate.",2020,"p = 0.002); however, the incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation showed no differences between the two study groups (p > 0.05).","['rhinoplasty', '128 volunteers - 33 men (25.8%) and 95 women (74.2%) - with a mean age of 26.23\xa0±\xa07.16 were included in this study', 'Volunteers with a physical status of ASA I']","['pregabalin', 'pregabalin and placebo', 'placebo']","['pain intensity', 'postoperative pain', 'horizontal visual analogue scale (VAS', 'incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation', 'Pain intensity scores']","[{'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",128.0,0.422842,"p = 0.002); however, the incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation showed no differences between the two study groups (p > 0.05).","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'School of Dentistry, Kermanshah University of Medical Sciences (KUMS), Iran.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Yazdani', 'Affiliation': 'Clinical Trials Center, KUMS, Iran.'}, {'ForeName': 'Hesamedin', 'Initials': 'H', 'LastName': 'Nazari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, KUMS, Iran. Electronic address: H.nazari@kums.ac.ir.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Choubsaz', 'Affiliation': 'Anesthesiology and Intensive Care, School of Medicine, KUMS, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Azizi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, KUMS, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Nazari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, KUMS, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Safari-Faramani', 'Affiliation': 'Epidemiology, Research Center for Environmental Determinants of Health, KUMS, Iran.'}, {'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Amiri', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, KUMS, Iran.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.03.006']
1686,32741773,Ubiquinol supplementation in elderly patients undergoing aortic valve replacement: biochemical and clinical aspects.,"Epidemiological data show a rise in the mean age of patients affected by heart disease undergoing cardiac surgery. Senescent myocardium reduces the tolerance to ischemic stress and there are indications about age-associated deficit in post-operative cardiac performance. Coenzyme Q10 (CoQ10), and more specifically its reduced form ubiquinol (QH), improve several conditions related to bioenergetic deficit or increased exposure to oxidative stress. This trial (Eudra-CT 2009-015826-13) evaluated the clinical and biochemical effects of ubiquinol in 50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either placebo or 400 mg/day ubiquinol from 7 days before to 5 days after surgery. Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin I, CK-MB (primary endpoints), IL-6 and S100B were assessed. Moreover, main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints) were evaluated during a 6-month follow-up visit. Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin I (QH, 1.90 [1.47-2.48] ng/dL; placebo, 4.03 [2.45-6.63] ng/dL; p=0.007) related to cardiac surgery. Moreover, ubiquinol prevented the adverse outcomes that might have been associated with defective left ventricular ejection fraction recovery in elderly patients.",2020,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"['50 elderly patients affected by severe aortic stenosis undergoing aortic valve replacement and randomized to either', 'elderly patients undergoing aortic valve replacement', 'mean age of patients affected by heart disease undergoing cardiac surgery', 'elderly patients']","['Coenzyme Q10 (CoQ10', 'Ubiquinol supplementation', 'placebo or 400 mg/day ubiquinol', 'dL; placebo']","['Plasma and cardiac tissue CoQ10 levels and oxidative status, circulating troponin', 'troponin', 'main cardiac adverse effects, NYHA class, contractility and myocardial hypertrophy (secondary endpoints', 'post-operative plasma CoQ10 decline (p<0.0001) and oxidation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1272575', 'cui_str': 'Heart tissue'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3495916', 'cui_str': 'Myocardial hypertrophy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",50.0,0.241265,Ubiquinol treatment counteracted the post-operative plasma CoQ10 decline (p<0.0001) and oxidation (p=0.038) and curbed the post-operative increase in troponin,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Orlando', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Sabbatinelli', 'Affiliation': 'Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, Ancona 60100, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Silvestri', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Marcheggiani', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Cirilli', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Phiwayinkosi Vusi', 'Initials': 'PV', 'LastName': 'Dludla', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Molardi', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nicolini', 'Affiliation': 'Cardiac Surgery Department, Parma University Hospital, Parma 43126, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tiano', 'Affiliation': 'Department of Life and Environmental Sciences, Università Politecnica delle Marche, Via Brecce Bianche, Ancona 60100, Italy.'}]",Aging,['10.18632/aging.103742']
1687,32751161,"Neurologic Safety of Etomidate-Based Sedation during Upper Endoscopy in Patients with Liver Cirrhosis Compared with Propofol: A Double-Blind, Randomized Controlled Trial.","(1) Background: Although etomidate-based sedation is an effective and safe protocol in endoscopic procedures, there is a lack of evidence regarding the safety of etomidate in patients with liver cirrhosis (LC). This study aimed to compare the neurologic safety and efficacy of etomidate and propofol for endoscopic sedation in patients with LC. (2) Methods: From December 2017 to December 2019, consecutive cirrhotic patients who underwent sedative endoscopy using either etomidate or propofol were randomly recruited. The primary endpoint was the number connection test (NCT), and the secondary endpoints included factors for the safety of sedatives during endoscopy. (3) Results: 63 patients were enrolled in each of the etomidate and propofol groups. The NCT times were significantly lower in the etomidate group than in the propofol group. Furthermore, severe or very severe degree of encephalopathy was higher in the propofol group but was not significantly different. Pharmacological properties and the overall incidence of respiratory and cardiovascular events did not differ significantly between the groups. (4) Conclusion: Etomidate-based sedation exacerbates neither subclinical nor overt hepatic encephalopathy. It guarantees efficacies similar to those of propofol regarding rapid sedation, fast recovery, and early discharge, with no increased risk of adverse respiratory or cardiovascular events in patients with LC.",2020,Pharmacological properties and the overall incidence of respiratory and cardiovascular events did not differ significantly between the groups.,"['patients with LC', '63 patients were enrolled in each of the etomidate and propofol groups', 'Patients with Liver Cirrhosis', 'patients with liver cirrhosis (LC', 'From December 2017 to December 2019, consecutive cirrhotic patients who underwent sedative endoscopy using either']","['etomidate', 'etomidate-based sedation', 'Etomidate-Based Sedation', 'Propofol', 'Etomidate-based sedation', 'etomidate or propofol', 'propofol', 'etomidate and propofol']","['safety of sedatives during endoscopy', 'neurologic safety and efficacy', 'Neurologic Safety', 'overall incidence of respiratory and cardiovascular events', 'risk of adverse respiratory or cardiovascular events', 'severe or very severe degree of encephalopathy', 'NCT times', 'rapid sedation, fast recovery, and early discharge', 'number connection test (NCT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",63.0,0.16516,Pharmacological properties and the overall incidence of respiratory and cardiovascular events did not differ significantly between the groups.,"[{'ForeName': 'Jang Han', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong-si 18450, Gyeonggi-do, Korea.'}, {'ForeName': 'Bomi', 'Initials': 'B', 'LastName': 'Hyun', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong-si 18450, Gyeonggi-do, Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong-si 18450, Gyeonggi-do, Korea.'}, {'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Koh', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong-si 18450, Gyeonggi-do, Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong-si 18450, Gyeonggi-do, Korea.'}, {'ForeName': 'Se Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong-si 18450, Gyeonggi-do, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9082424']
1688,32728226,"A randomised, prospective study of 'off-the-shelf' use of toric intraocular lenses for cataract patients with pre-existing corneal astigmatism in the NHS.","BACKGROUND/OBJECTIVES


To compare visual and refractive outcomes of monofocal intraocular lenses (IOLs) with limbal relaxing incisions (LRI) with 'off-the-shelf' use of toric IOLs (TIOLs), with a fixed 2-dioptre cylinder (DC) correction, for cataract patients with pre-existing corneal astigmatism in a public-sector setting.
SUBJECTS/METHODS


Seventy-seven patients (77 eyes, first treated eye) with visually significant cataract and pre-operative corneal astigmatism ≥2.00 DC were randomised to receive either 'off-the-shelf' TIOLs, with a fixed 2.00 DC cylinder correction (39 eyes), or monofocal IOLs (38 eyes) with LRIs. The concept of fixing the cylindrical correction was to minimise costs, allow a full TIOL bank to be available and eliminate the need for individual TIOL ordering. Outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and refraction. Astigmatic changes were evaluated using the Alpins vector method.
RESULTS


Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18 (SD 0.19)[~20/30] post-operatively in TIOL group, versus 0.82 (SD 0.55)[~20/130] to 0.27 (SD 0.15)[~20/40] in monofocal/LRI group (P = 0.02; 95% CI: -0.17, -0.01). Mean CDVA improved from logMAR 0.40 (SD 0.26)[~20/50] to 0.01 (SD 0.12)[~20/20] in TIOL group, and 0.41 (SD 0.38)[~20/40] to 0.06 (SD 0.12)[~20/25] in LRI group (P = 0.07; 95% CI: -0.11, 0.01). Average post-operative refractive cylinder in TIOL group was 1.35 DC (SD 0.84 DC) and in LRI group 1.91 DC (SD 1.07 DC) (P = 0.01; 95% CI: -1, -0.12). Mean difference vector magnitude was 1.92 DC (SD 1.08 DC) in LRI group and 1.37 DC (SD 0.84 DC) in TIOL group (P = 0.02; 95% CI: 0.11, 0.99).
CONCLUSIONS


TIOLs with a fixed 2.00 DC correction during cataract surgery may improve UDVA, reduce post-operative cylinder and result in a more reliable astigmatic correction compared with monofocal IOLs with LRIs.",2020,"RESULTS


Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18","['Seventy-seven patients (77 eyes, first treated eye) with visually significant cataract and pre-operative corneal astigmatism', 'cataract patients with pre-existing corneal astigmatism in the NHS', 'cataract patients with pre-existing corneal astigmatism in a public-sector setting']","['fixed 2.00 DC cylinder correction (39 eyes), or monofocal IOLs (38 eyes) with LRIs', 'monofocal intraocular lenses (IOLs) with limbal relaxing incisions (LRI', 'toric IOLs (TIOLs), with a fixed 2-dioptre cylinder (DC) correction', 'toric intraocular lenses']","['Mean difference vector magnitude', 'uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and refraction', 'Mean CDVA', 'Mean UDVA']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]",,0.196616,"RESULTS


Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Stanojcic', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK. nstanojcic@doctors.org.uk.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Wagh', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Zuberbuhler', 'Affiliation': 'Zubimed Augenzentrum, Niederhasli, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Brart"", 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}]","Eye (London, England)",['10.1038/s41433-020-0919-8']
1689,32734423,Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE.,"INTRODUCTION


Nintedanib, a tyrosine kinase receptor inhibitor, may be associated with increased bleeding risk. Thus, patients with an inherited predisposition to bleeding, or those receiving therapeutic doses of anticoagulants or high-dose antiplatelet therapy, have been excluded from clinical trials of nintedanib in idiopathic pulmonary fibrosis (IPF).
OBJECTIVE


Our objective was to examine real-world bleeding events in patients with IPF treated with antifibrotics, including those receiving anticoagulants and/or antiplatelet therapy.
METHODS


The European MultiPartner IPF Registry (EMPIRE) enrolled 2794 patients with IPF: group A (1828: no anticoagulant or antiplatelet treatment), group B (227: anticoagulant treatment), group C (659: antiplatelet treatment), and group D (80: anticoagulant and antiplatelet treatment). Overall, 673 (24.1%) received nintedanib and 933 (33.4%) received pirfenidone. Bleeding events and their relationship to antifibrotic and anticoagulation treatment were characterized.
RESULTS


Group A patients, versus those in groups B, C, and D, were typically younger and generally had the lowest comorbidity rates. A higher proportion of patients in groups A and C, versus group B, received nintedanib. Pirfenidone, most common in group D, was more evenly balanced across groups. In patients with reported bleeding events, seven of eight received nintedanib (groups A, C, and D). Bleeding incidence was 3.0, 0, 1.3, and 18.1 per 10,000 patient-years (groups A, B, C, and D, respectively).
CONCLUSION


Real-world data from EMPIRE showed that patients on anticoagulant medications received nintedanib less frequently, perhaps based on its mechanism of action. Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).",2020,"Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).","['2794 patients with IPF: group A', 'patients with an inherited predisposition to bleeding, or those receiving therapeutic doses of anticoagulants or high-dose antiplatelet therapy, have been excluded from clinical trials of nintedanib in idiopathic pulmonary fibrosis (IPF', 'Central European Patients with Idiopathic Pulmonary Fibrosis (IPF', 'patients with IPF treated with antifibrotics, including those receiving anticoagulants and/or antiplatelet therapy']","['Pirfenidone', 'pirfenidone']","['Bleeding incidence', 'Bleeding events', 'Anticoagulant Use and Bleeding Risk', 'Overall, bleeding incidence', 'bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0314657', 'cui_str': 'Genetic predisposition'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2794.0,0.0171192,"Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).","[{'ForeName': 'Abigél M', 'Initials': 'AM', 'LastName': 'Kolonics-Farkas', 'Affiliation': 'Department of Pulmonology, Semmelweis University, Tömő utca 25-29, Budapest, 1083, Hungary. kolonics-farkas.abigel@med.semmelweis-univ.hu.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Šterclová', 'Affiliation': 'Department of Respiratory Diseases of the First Faculty of Medicine, Charles University, Thomayer Hospital, Prague, Czech Republic.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Mogulkoc', 'Affiliation': 'Department of Pulmonary Medicine, Ege University Medical School, Izmir, Turkey.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kus', 'Affiliation': 'Department of Pulmonary Diseases, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Hájková', 'Affiliation': 'Clinic of Pneumology and Phthisiology, University Hospital Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Pulmonology, Semmelweis University, Tömő utca 25-29, Budapest, 1083, Hungary.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Jovanovic', 'Affiliation': 'University Hospital of Pulmonology, Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Jasna', 'Initials': 'J', 'LastName': 'Tekavec-Trkanjec', 'Affiliation': 'Pulmonary Department, University Hospital Dubrava, Zagreb, Croatia.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Littnerová', 'Affiliation': 'Institute of Biostatistics and Analyses, Masaryk University, Faculty of Medicine, Brno, Czech Republic.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Hejduk', 'Affiliation': 'Institute of Biostatistics and Analyses, Masaryk University, Faculty of Medicine, Brno, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vašáková', 'Affiliation': 'Department of Respiratory Diseases of the First Faculty of Medicine, Charles University, Thomayer Hospital, Prague, Czech Republic.'}]",Drug safety,['10.1007/s40264-020-00978-5']
1690,32734480,"Correction to: Health economic evaluation of an internet intervention for depression (deprexis), a randomized controlled trial.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],['internet intervention'],[],[],"[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]",[],,0.08344,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Gräfe', 'Affiliation': 'Department of Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany. viola.graefe@uni-bielefeld.de.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Greiner', 'Affiliation': 'Department of Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany.'}]",Health economics review,['10.1186/s13561-020-00280-1']
1691,32730283,"Comparison of Glidescope® Go™, King Vision™, Dahlhausen VL, I‑View™ and Macintosh laryngoscope use during difficult airway management simulation by experienced and inexperienced emergency medical staff: A randomized crossover manikin study.","BACKGROUND


In pre-hospital emergency care, video laryngoscopes (VLs) with disposable blades are preferably used due to hygienic reasons. However, there is limited existing data on the use of VLs with disposable blades by emergency medical staff. Therefore, the aim of this study was to compare the efficacy of four different VLs with disposable blades and the conventional standard Macintosh laryngoscope, when used by anesthetists with extensive previous experience and paramedics with little previous experience in endotracheal intubation (ETI) in a simulated difficult airway.
METHODS


Fifty-eight anesthetists and fifty-four paramedics participated in our randomized crossover manikin trial. Each performed ETI with the new Glidescope® Go™, the Dahlhausen VL, the King Vision™, the I-View™ and the Macintosh laryngoscope. ""Time to intubate"" was the primary endpoint. Secondary endpoints were ""time to vocal cords"", ""time to ventilate"", overall success rate, number of intubation attempts and optimization maneuvers, Cormack-Lehane score, severity of dental compression and subjective impressions.
RESULTS


The Glidescope® Go™, the Dahlhausen VL and the King Vision™ provided superior intubation conditions in both groups without affecting the number of intubation attempts or the time required for successful intubation. When used by anesthetists with extensive experience in ETI, the use of VLs did not affect the overall success rate. In the hands of paramedics with little previous experience in ETI, the failure rate with the Macintosh laryngoscope (14.8%) decreased to 3.7% using the Glidescope® Go™ and the Dahlhausen VL. Despite the advantages of hyperangulated video laryngoscopes, the I-View™ performed worst.
CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI. Our results therefore suggest that hyperangulated VLs could be beneficial and might be the method of choice in comparable settings, especially for emergency medical staff with less experience in ETI.",2020,"CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI.",['Fifty-eight anesthetists and fifty-four paramedics participated'],"['conventional standard Macintosh laryngoscope', 'endotracheal intubation (ETI']","['number of intubation attempts or the time required for successful intubation', 'overall success rate', 'failure rate', 'Dahlhausen VL and the King Vision™', 'time to vocal cords"", ""time to ventilate"", overall success rate, number of intubation attempts and optimization maneuvers, Cormack-Lehane score, severity of dental compression and subjective impressions']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",58.0,0.028898,"CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Moritz', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Leonhardt', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Prottengeier', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Birkholz', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Irouschek', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}]",PloS one,['10.1371/journal.pone.0236474']
1692,32730289,Acute effects of kinesiology tape tension on soleus muscle h-reflex modulations during lying and standing postures.,"Kinesiology tape (KT) has been widely used in the areas of sports and rehabilitation. However, there is no gold standard for the tape tension used during a KT application. The purpose of this study was to examine the effects of KT application with different tension intensities on soleus muscle Hoffmann-reflex (H-reflex) modulation during lying and standing postures. Fifteen healthy university students were tested with 3 tape tension intensities during separate visits with a randomized sequence: tape-on no tension (0KT), moderate (about 50% of the maximal tape tension: (ModKT), and maximal tape tension (MaxKT). During each experimental visit, the H-reflex measurements on the soleus muscle were taken before, during, and after the KT application for both lying and standing postures. The H-wave and M-wave recruitment curves were generated using surface electromyography (EMG). There was a main effect for posture (p = 0.001) for the maximal peak-to-peak amplitude of the H-wave and M-wave (Hmax/Mmax) ratio, showing the depressed Hmax/Mmax ratio during standing, when compared to the lying posture. Even though the tension factor had a large effect (ηp2 = 0.165), different tape tensions showed no significant differential effects for the Hmax/Mmax ratio. The spinal motoneuron excitability was not altered, even during the maximal tension KT application on the soleus muscle. Thus, the tension used during a KT application should not be a concern in terms of modulating the sensorimotor activity ascribed to elastic taping during lying and standing postures.",2020,"There was a main effect for posture (p = 0.001) for the maximal peak-to-peak amplitude of the H-wave and M-wave (Hmax/Mmax) ratio, showing the depressed Hmax/Mmax ratio during standing, when compared to the lying posture.",['Fifteen healthy university students'],"['kinesiology tape tension', '3 tape tension intensities during separate visits with a randomized sequence: tape-on no tension (0KT), moderate (about 50% of the maximal tape tension: (ModKT), and maximal tape tension (MaxKT', 'KT', 'Kinesiology tape (KT']","['spinal motoneuron excitability', 'soleus muscle Hoffmann-reflex (H-reflex) modulation', 'soleus muscle h-reflex modulations', 'maximal peak-to-peak amplitude of the H-wave and M-wave (Hmax/Mmax) ratio']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C0026609', 'cui_str': 'Motor neuron'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0133263,"There was a main effect for posture (p = 0.001) for the maximal peak-to-peak amplitude of the H-wave and M-wave (Hmax/Mmax) ratio, showing the depressed Hmax/Mmax ratio during standing, when compared to the lying posture.","[{'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chin', 'Initials': 'WC', 'LastName': 'Tseng', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Che-Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Sport Performance, National Taiwan University of Sports, Taichung, Taiwan.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': 'Escola Superior de Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Melgaço, Portugal.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, The University of Mississippi, Oxford, Mississippi, United States of America.'}]",PloS one,['10.1371/journal.pone.0236587']
1693,32730920,The role of endogenous GIP and GLP-1 in postprandial bone homeostasis.,"The incretin hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are well known for their insulinotropic effects and they are thought to affect bone homeostasis as mediators in the so-called entero-osseous axis. We examined the contributions of endogenous GIP and GLP-1, respectively, to postprandial bone homeostasis, in healthy subjects in two randomized and double-blind crossover studies. We included healthy men who received either four oral glucose tolerance tests (OGTTs) (n = 18, median age 27 (range 20-70), BMI 27.2 (22.4-37.0) kg/m 2 ) or liquid mixed meal tests (MMTs) (n = 12, age 23 (19-65), BMI 23.7 (20.3-25.5) kg/m 2 ) with infusions of 1) the GIP receptor antagonist GIP(3-30)NH 2 , 2) the GLP-1 receptor antagonist exendin(9-39)NH 2 , 3) both GIP(3-30)NH 2  and exendin(9-39)NH 2 , or 4) placebo infusions (saline) on four separate visits. Bone resorption was evaluated from levels of circulating carboxy-terminal collagen crosslinks (CTX) and bone formation from levels of procollagen type 1 amino-terminal propeptide (P1NP). During placebo infusions, baseline-subtracted area under the curve values for CTX were -39 ± 5.0 (OGTT) and -57 ± 4.3 ng/ml × min (MMT). When GIP(3-30)NH 2  was administered, CTX suppression was significantly diminished compared to placebo (-30 ± 4.8 (OGTT) and -45 ± 4.6 ng/ml × min (MMT), P = 0.0104 and P = 0.0288, respectively, compared to placebo. During exendin(9-39)NH 2  infusion, CTX suppression after OGTT/MMT was similar to placebo (P = 0.28 (OGTT) and P = 0.93 (MMT)). The relative contribution of endogenous GIP to postprandial suppression of bone resorption during both OGTT and MMT was similar and reached 22-25%. There were no differences in P1NP concentrations between interventions. In conclusion, endogenous GIP contributes by up to 25% to postprandial suppression of bone resorption in humans whereas an effect of endogenous GLP-1 could not be demonstrated.",2020,There were no differences in P1NP concentrations between interventions.,"['healthy subjects', 'healthy men who received either four oral glucose tolerance tests (OGTTs) (n = 18, median age 27 (range 20-70), BMI 27.2 (22.4-37.0) kg/m 2 ) or']","['liquid mixed meal tests (MMTs', 'placebo infusions (saline', 'placebo']","['bone resorption', 'CTX suppression', 'P1NP concentrations', 'Bone resorption']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191357', 'cui_str': '27.2'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.20213,There were no differences in P1NP concentrations between interventions.,"[{'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Stensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark. Electronic address: filipknop@dadlnet.dk.'}]",Bone,['10.1016/j.bone.2020.115553']
1694,32730930,A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures.,"Bone morphogenetic proteins (BMPs) are known to induce new bone formation in vivo but treating trabecular bone defects with a BMP based therapeutic remains controversial. Here, we evaluated the safety and efficacy of a novel Autologous Bone Graft Substitute (ABGS) comprised of recombinant human BMP6 (rhBMP6) dispersed within an autologous blood coagulum (ABC) as a physiological natural carrier in patients with a closed distal radial fracture (DRF). We enrolled 32 patients in a randomized, standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase I First in Human (FiH) clinical trial. ABGS was prepared from peripheral blood as 250 μg rhBMP6/mL ABC or PBO (1 mL ABC containing excipients only) and was administered dorsally via a syringe injection into the fracture site following closed fracture fixation with 3 Kirschner wires. Patients carried an immobilization for 5 weeks and were followed-up for 0 to 26 weeks by clinical examination, safety, serial radiographic analyses and CT. During the 13 weeks follow-up and at 26 weeks post study there were no serious adverse reactions recorded. The results showed that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 32 patients at 13- and 26-weeks following treatment. Pharmacokinetic analyses of plasma from patients treated with ABGS showed no detectable rhBMP6 at any time point within the first 24 h following administration. The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P = 0.027), while at week 13 all patients had similar healing outcomes. In conclusion, we show that intraosseous administration of ABGS (250 μg rhBMP6/mL ABC) into the distal radial fracture site demonstrated a good tolerability with no serious adverse reactions as well as early accelerated trabecular bone healing as compared to control PBO and SoC patients.",2020,"The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes.","['patients with distal radial fractures', 'patients with a closed distal radial fracture (DRF']","['ABGS', 'novel Autologous Bone Graft Substitute (ABGS', 'standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase', 'novel autologous bone graft substitute', 'Bone morphogenetic proteins (BMPs', 'recombinant human BMP6 (rhBMP6']","['accelerated bone healing', 'safety and efficacy', 'CT image and radiographic analyses score', 'detectable anti-rhBMP6 antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0053932', 'cui_str': 'Bone morphogenetic proteins'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",32.0,0.0547507,"The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes.","[{'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Durdevic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Vlahovic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Pehar', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Miklic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Oppermann', 'Affiliation': 'Genera Research, Svetonedeljska 2, Kalinovica, 10436, Rakov Potok, Croatia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Bordukalo-Niksic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Ismet', 'Initials': 'I', 'LastName': 'Gavrankapetanovic', 'Affiliation': 'University Clinical Center Sarajevo, Clinic of Orthopedics and Traumatology, Bolnicka 25, 71000 Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Mehmed', 'Initials': 'M', 'LastName': 'Jamakosmanovic', 'Affiliation': 'University Clinical Center Sarajevo, Clinic of Orthopedics and Traumatology, Bolnicka 25, 71000 Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'School of Public Health ""Andrija Stampar"", University of Zagreb School of Medicine, Rockefellerova 4, 10000 Zagreb, Croatia.'}, {'ForeName': 'Snjezana', 'Initials': 'S', 'LastName': 'Martinovic', 'Affiliation': 'SmartMedico, Zupanova 5, 10000 Zagreb, Croatia.'}, {'ForeName': 'T Kuber', 'Initials': 'TK', 'LastName': 'Sampath', 'Affiliation': 'perFormBiologics Inc., Holliston, MA 01746, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department for Intracellular Communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 2, 10000 Zagreb, Croatia.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Grgurevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Vukicevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia. Electronic address: slobodan.vukicevic@mef.hr.'}]",Bone,['10.1016/j.bone.2020.115551']
1695,32737087,"Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study.","INTRODUCTION


Opioid agonist treatment is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
METHODS AND ANALYSIS


The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR injections in people with opioid dependence. Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32 mg of sublingual buprenorphine (±naloxone), participants will receive monthly subcutaneous BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14 days). The primary endpoint is participant retention in treatment at 48 weeks after treatment initiation. Secondary endpoints will evaluate dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience. Qualitative and costing substudies will examine implementation barriers and facilitators at the client and provider level.
ETHICS AND DISSEMINATION


The study has received ethics approval from the St Vincent's Hospital Sydney Human Research Ethics Committee (Ref. HREC/18/SVH/221). The findings will be disseminated via publication in peer-reviewed journals, presentations at national and international scientific conferences, and in relevant community organisation publications and forums.
TRIAL REGISTRATION NUMBER


NCT03809143 PROTOCOL IDENTIFIER: CoLAB1801, V.4.0 dated 01 August 2019.",2020,"The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
","['people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia', 'Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia', 'people with opioid dependence']","['depot buprenorphine', 'Buprenorphine (CoLAB', 'subcutaneous BUP-XR injections', 'BUP-XR injections', 'sublingual buprenorphine (±naloxone']","['participant retention', 'dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.105725,"The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
","[{'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Larance', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Discipline of Addiction Medicine, University of Sydney, Surry Hills, New South Wales, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Grebely', 'Affiliation': 'The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Degenhardt', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeyran', 'Initials': 'J', 'LastName': 'Shahbazi', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Shanahan', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lancaster', 'Affiliation': 'Centre for Social Research in Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Dore', 'Affiliation': 'The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ali', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia michael.farrell@unsw.edu.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034389']
1696,32735987,"A two-site, open-label, non-randomized trial comparing Focal Electrically-Administered Seizure Therapy (FEAST) and right unilateral ultrabrief pulse electroconvulsive therapy (RUL-UBP ECT).","BACKGROUND


Focal Electrically-Administered Seizure Therapy (FEAST) is a form of electroconvulsive therapy (ECT) that spatially focuses the electrical stimulus to initiate seizure activity in right prefrontal cortex. Two open-label non-comparative studies suggested that FEAST has reduced cognitive side effects when compared to historical data from other forms of ECT. In two different ECT clinics, we compared the efficacy and cognitive side effects of FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT.
METHODS


Using a non-randomized, open-label design, 39 depressed adults were recruited after referral for ECT. Twenty patients received FEAST (14 women; age 45.2 ± 12.7), and 19 received RUL-UBP ECT (16 women; age 43.2 ± 16.4). Key cognitive outcome measures were the postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF). Antidepressant effects were assessed using the Hamilton Rating Scale for Depression (HRSD 24 ).
RESULTS


In the Intent-to-treat sample, a repeated measures mixed model suggested no between group difference in HRSD 24  score over time (F 1,35  = 0.82, p = 0.37), while the response rate favored FEAST (FEAST: 65%; RUL-UBP ECT: 57.9%), and the remission rate favored RUL-UBP ECT (FEAST: 35%; RUL-UBP ECT: 47.4%). The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6 ± 5.0 min; RUL-UBP ECT: 8.8 ± 5.8 min; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2 ± 14.2%; RUL-UBP ECT: 63.9 ± 9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
CONCLUSIONS


FEAST exerts similar efficacy relative to an optimal form of conventional ECT and may have milder cognitive side effects. A blinded, randomized, non-inferiority trial is needed.",2020,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","['Twenty patients received FEAST (14 women; age 45.2±12.7), and 19 received', '39 depressed adults were recruited after referral for ECT']","['electroconvulsive therapy (ECT', 'FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT', 'Focal Electrically-Administered Seizure Therapy (FEAST) and Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy (RUL-UBP ECT', 'RUL-UBP ECT', 'FEAST', 'Focal Electrically-Administered Seizure Therapy (FEAST']","['cognitive side effects', 'CUAMI-SF consistency score', 'efficacy and cognitive side effects', 'postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF', 'Hamilton Rating Scale for Depression (HRSD 24 ', 'numeric superiority', 'Antidepressant effects', 'HRSD 24  score over time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0451013', 'cui_str': 'Autobiographical memory interview'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",39.0,0.0739028,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Sahlem', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA. Electronic address: sahlem@musc.edu.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'E Baron', 'Initials': 'EB', 'LastName': 'Short', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fox', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Manett', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Kerns', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Dancy', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA; Ralph H. Johnson VA Medical Center, SC, USA.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.015']
1697,32738408,Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.,"For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.",2020,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"['diverse patients attending HIV primary care clinics', 'Eligible and consenting patients from four HIV primary care clinical sites', 'people with HIV in health care', 'patients seen in HIV primary care']",['Positive Health Check intervention in addition to the standard of care or the standard of care only'],['HIV viral loads'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",4.0,0.0882936,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America. Electronic address: melewis@rti.org.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Harshbarger', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burrus', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Peinado', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Khavjou', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Karns', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Zulkiewicz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Galindo', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DallaPiazza', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Holm', 'Affiliation': 'NO AIDS Task Force dba CrescentCare, New Orleans, LA, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, Emory Vaccine Center, and Rollins School of Public Health, Atlanta, GA, United States of America; Atlanta VA Medical Center, Decatur, GA, United States of America.'}, {'ForeName': 'Charurut', 'Initials': 'C', 'LastName': 'Somboonwit', 'Affiliation': 'University of South Florida, Morsani College of Medicine, Tampa, FL, United States of America.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106097']
1698,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND


Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS


To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS


Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION


Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
1699,32743789,"Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical Investigation.","INTRODUCTION


Over the last few years, it has been demonstrated that a moist environment enhances the healing process and reduces scar formation of wounds. Such moist conditions can be created and maintained using hydrogels. The aim of this study was to evaluate wound healing, cooling efficacy, local tolerability, and cosmetic appearance of abrasive wounds treated with BepanGel wound care hydrogel.
METHODS


This study was designed as a within-person, single-center, randomized, investigator-blind clinical investigation comparing a hydrogel-treated test field with an untreated test field in an abrasive wound model. In 33 subjects, two small superficial wounds were induced on the non-dominant forearms. Wounds were treated with BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone for 11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of the treatment were assessed over 12 investigational days. During follow-up at day 31, the cosmetic appearance of the wounds was evaluated.
RESULTS


On day 12, the test field treated with BepanGel was completely healed in nearly all subjects (97.0%) in contrast with the test field treated with a plaster alone (18.2%, AUC days 2-12  p < 0.0001) as assessed by a blinded investigator. Two-thirds of the unblinded subjects indicated an immediate cooling effect of the hydrogel (p = 0.0555). At the end of the investigation, the cosmetic appearance of the BepanGel-treated test fields scored superior to the fields treated with a plaster alone as evaluated by a blinded investigator (p = 0.0005) and the unblinded subjects (p = 0.0078). The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
CONCLUSION


This evaluation shows that treatment of superficial cutaneous wounds with BepanGel results in improved wound healing as demonstrated by faster wound closure and a considerably better cosmetic appearance, while providing immediate cooling.
TRIAL REGISTRATION NUMBER


EUDAMED-No.: CIV-19-09-029744.",2020,"The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
","['33 subjects, two small superficial wounds were induced on the non-dominant forearms']","['BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone', 'BepanGel wound care hydrogel']","['cosmetic appearance', 'Wound healing efficacy, cooling effect, and tolerability', 'wound healing, cooling efficacy, local tolerability, and cosmetic appearance', 'tolerated and no signs of infection or adverse events (AEs', 'wound healing', 'immediate cooling effect']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}]","[{'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",,0.0224654,"The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'de Salvo', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Trapp', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Wigger-Alberti', 'Affiliation': 'Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.'}, {'ForeName': 'Ragna', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Delcour', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Rossel', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.'}, {'ForeName': 'Maarten T', 'Initials': 'MT', 'LastName': 'Huisman', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium. mh@oystershell.be.'}]",Dermatology and therapy,['10.1007/s13555-020-00432-5']
1700,32739331,Which brand should be more nervous about nutritional information disclosure: McDonald's or Subway?,"This study examines the health halo and horn effects in the context of two fast food brands commonly associated with healthy and unhealthy food (i.e., Subway and McDonald's). Health halo is consumers' tendency to overestimate the healthiness of certain food categories or items based on a single claim, whereas health horn is the tendency to underestimate it. Specifically, we investigated the moderating effects of nutritional information disclosure and dietary restraint on consumers' behavioral intentions. Two items from the McDonald's and Subway menus each served as stimuli. They represented health halo confirmation (Roast Chicken sandwich) or disconfirmation (Italian Spicy sandwich) and health horn confirmation (Big Mac burger) or disconfirmation (McSpicy Cajun Burger). This study employed a 2 (nutritional information: present vs. absent) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) mixed factorial design. Participants were randomly assigned to one of two experimental conditions (nutritional information: present vs. absent) and presented with all four menu items. There was a decrease in behavioral intentions toward all menu items except the one representing health horn disconfirmation. In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich). The findings not only delineate the different practices companies adopt but also underscore the importance of nutritional information disclosure in helping consumers make healthier food choices.",2020,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[""consumers' behavioral intentions""]","[""absent)\u202f×\u202f4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters"", 'nutritional information disclosure and dietary restraint', ""health halo or horn associated with Subway or McDonald's menu items""]",['behavioral intentions'],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0019939', 'cui_str': 'Horns'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0524709', 'cui_str': 'Subways'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0167676,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[{'ForeName': 'Meeyoung', 'Initials': 'M', 'LastName': 'Joe', 'Affiliation': 'Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 505, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: cookie22@yonsei.ac.kr.'}, {'ForeName': 'Seoki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Hospitality Management, The Pennsylvania State University, 217 Mateer Building University Park, PA, 16802, USA. Electronic address: leeseoki@psu.edu.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Ham', 'Affiliation': 'Dept. of Food & Nutrition, Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 510, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: sham2@yonsei.ac.kr.'}]",Appetite,['10.1016/j.appet.2020.104805']
1701,32739411,Apple polyphenol-rich drinks dose-dependently decrease early-phase postprandial glucose concentrations following a high-carbohydrate meal: a randomized controlled trial in healthy adults and in vitro studies.,"BACKGROUND


Previous research demonstrated that a high dose of phlorizin-rich apple extract (AE) can markedly inhibit early-phase postprandial glycemia, but efficacy of lower doses of the AE is unclear.
OBJECTIVE


To determine whether lower AE doses reduce early-phase postprandial glycemia in healthy adults and investigate mechanisms.
DESIGN


In a randomized, controlled, double-blinded, cross-over acute trial, drinks containing 1.8 g (HIGH), 1.35 g (MED), 0.9 g (LOW), or 0 g (CON) of a phlorizin-rich AE were consumed before 75 g starch/sucrose meal. Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations were measured 0-240 min, acetaminophen concentrations to assess gastric emptying rate, and 24 h urinary glucose excretion. Effects of AE on intestinal glucose transport were investigated in Caco-2/TC7 cells.
RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were -15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0) and -8.99 (-17.3, -0.7) mmol/L per minute for HIGH, MEDIUM and LOW respectively, delayed T max  (HIGH, MEDIUM and LOW 45 min vs. CON 30 min), but did not lower C max . Similar dose-dependent treatment effects were observed for insulin, C-peptide, and GIP. Gastric emptying rates and urinary glucose excretion did not differ. Serum phloretin, quercetin and epicatechin metabolites were detected postprandially. A HIGH physiological AE dose equivalent decreased total glucose uptake by 48% in Caco-2/TC7 cells.
CONCLUSIONS


Phlorizin-rich AE, even at a low dose, can slightly delay early-phase glycemia without affecting peak and total glycemic response.",2020,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)",['healthy adults'],"['Apple polyphenol-rich drinks', 'phlorizin-rich apple extract (AE', 'AE', 'phlorizin-rich AE were consumed before 75 g starch/sucrose meal']","['Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations', 'gastric emptying rate, and 24 h urinary glucose excretion', 'total glucose uptake', 'Serum phloretin, quercetin and epicatechin metabolites', 'Gastric emptying rates and urinary glucose excretion', 'total glycaemic response', 'insulin, C-peptide, and GIP', 'early-phase postprandial glucose concentrations', 'plasma glucose iAUC', 'delayed T max  ', 'intestinal glucose transport']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0031562', 'cui_str': 'Phlorhizin'}, {'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031560', 'cui_str': 'Phloretin'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]",,0.233603,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Prpa', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Corpe', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Atkinson', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Blackstone', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Leftley', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Parekh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Philo', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK. Electronic address: wendy.hall@kcl.ac.uk.""}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108466']
1702,32755396,"Electrical Posterior Box Isolation in Persistent Atrial Fibrillation Changed to Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Study.","BACKGROUND


Persistent atrial fibrillation (AF) can change to paroxysmal AF after antiarrhythmic drug medication and cardioversion. We investigated whether electrical posterior box isolation (POBI) may improve rhythm outcome of catheter ablation in those patient groups.
METHODS


We prospectively randomized 114 patients with persistent AF to paroxysmal AF (men, 75%; 59.8±9.9 years old) to circumferential pulmonary vein isolation (CPVI) alone group (n=57) and additional POBI group (n=57). Primary end point was AF recurrence after a single procedure, and secondary end points were recurrence pattern, cardioversion rate, and response to antiarrhythmic drugs.
RESULTS


After a mean follow-up of 23.8±10.2 months, the clinical recurrence rate did not significantly differ between the CPVI alone and additional POBI group (31.6% versus 28.1%;  P =0.682; log-rank  P =0.729). The recurrences as atrial tachycardias (5.3% versus 12.3%;  P =0.134) and cardioversion rates (5.3% versus 10.5%;  P =0.250) were not significantly different between the CPVI and POBI groups. At the final follow-up, sinus rhythm was maintained without antiarrhythmic drug in 52.6% of CPVI group and 59.6% of POBI group ( P =0.450). No significant difference was found in major complication rates between the two groups (5.3% versus 1.8%;  P =0.618), but the total ablation time was significantly longer in the POBI group (4187±952 versus 5337±1517 s;  P <0.001).
CONCLUSIONS


In patients with persistent AF converted to paroxysmal AF by antiarrhythmic drug, the addition of POBI to CPVI did not improve the rhythm outcome of catheter ablation or influence overall safety, while leading to longer ablation time. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02176616.",2020,"The recurrences as atrial tachycardias (5.3% vs. 12.3%, p=0.134) and cardioversion rates (5.3% vs. 10.5%, p=0.250) were not significantly different between the CPVI and POBI group.","['Paroxysmal Atrial Fibrillation', '114 patients with PeAF to PAF (male 75%, 59.8 ± 9.9 years old) to circumferential pulmonary vein isolation (CPVI) alone group (n=57) and additional POBI group (n=57']","['Electrical Posterior Box Isolation', 'electrical posterior box isolation (POBI', '  - Persistent atrial fibrillation (PeAF']","['clinical recurrence rate', 'rhythm outcome of catheter ablation', 'recurrences as atrial tachycardias', 'recurrence pattern, cardioversion rate, and response to AADs', 'cardioversion rates', 'major complication rates', 'AF recurrence', 'total ablation time']","[{'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032172', 'cui_str': 'Platelet activating factor'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",114.0,0.0438541,"The recurrences as atrial tachycardias (5.3% vs. 12.3%, p=0.134) and cardioversion rates (5.3% vs. 10.5%, p=0.250) were not significantly different between the CPVI and POBI group.","[{'ForeName': 'Hui-Nam', 'Initials': 'HN', 'LastName': 'Pak', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Junbeom', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Ewha Womans University Medical Center, Seoul, Republic of Korea (J.P.).'}, {'ForeName': 'Je-Wook', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Song-Yi', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Hee Tae', 'Initials': 'HT', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Jae-Sun', 'Initials': 'JS', 'LastName': 'Uhm', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Jong-Il', 'Initials': 'JI', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Korea University Medical Center, Seoul, Republic of Korea (J.I.C., Y.-H.K., J.S.).'}, {'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Joung', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Moon-Hyoung', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Yonsei University Health System, Seoul, Republic of Korea (H.-N.P., J.-W.P., S.-Y.Y., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L.).'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Korea University Medical Center, Seoul, Republic of Korea (J.I.C., Y.-H.K., J.S.).'}, {'ForeName': 'Jaemin', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Department of Cardiology, Korea University Medical Center, Seoul, Republic of Korea (J.I.C., Y.-H.K., J.S.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008531']
1703,32760144,A gender-sensitised weight-loss and healthy living program for men with overweight and obesity in Australian Football League settings (Aussie-FIT): A pilot randomised controlled trial.,"BACKGROUND


Recent evidence shows that sport settings can act as a powerful draw to engage men in weight loss. The primary objective of this pilot study was to test the feasibility of delivering and to evaluate preliminary efficacy of Aussie-FIT, a weight-loss program for men with overweight/obesity delivered in Australian Football League (AFL) settings, in preparation for a future definitive trial.
METHODS AND FINDINGS


This 6-month pilot trial took place in Perth, Australia. Participants were overweight/obese (Body Mass Index [BMI] ≥ 28 kg/m2), middle-aged (35-65 years old) men. Participants were recruited in May 2018, and the intervention took place between June and December 2018. The intervention involved 12 weekly 90-min face-to-face sessions, incorporating physical activity, nutrition, and behaviour change information and practical activities delivered by coaches at 2 clubs. Data were collected at baseline and immediately postintervention. For trial feasibility purposes, 6-month follow-ups were completed. Outcomes were differences in weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure at 3 months. Within 3 days of advertising at each club, 426 men registered interest; 306 (72%) were eligible. Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87) and randomised by a blinded researcher. Trial retention was 86% and 63% at 3- and 6-month follow-ups (respectively). No adverse events were reported. At 3 months, mean difference in weight between groups, adjusted for baseline weight and group, was 3.3 kg (95% CI 1.9, 4.8) in favour of the intervention group (p < 0.001). The intervention group's moderate-to-vigorous physical activity (MVPA) was higher than the control group by 8.54 min/day (95% CI 1.37, 15.71, p = 0.02). MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
CONCLUSIONS


Aussie-FIT was feasible to deliver; participants increased physical activity, decreased weight, and reported improvements in other outcomes. Issues with retention were a limitation of this trial. In a future, fully powered randomised controlled trial (RCT), retention could be improved by conducting assessments outside of holiday seasons.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.",2020,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","['men with overweight/obesity delivered in Australian Football League (AFL) settings', '426 men registered interest; 306 (72%) were eligible', '28 kg/m2), middle-aged (35-65 years old) men', 'men with overweight and obesity in Australian Football League settings (Aussie-FIT', 'Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87', 'Participants were overweight/obese', 'Participants were recruited in May 2018, and the intervention took place between June and December 2018']","['MVPA', 'Aussie-FIT, a weight-loss program']","['weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure', 'moderate-to-vigorous physical activity (MVPA', 'physical activity, decreased weight', 'adverse events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.212539,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kwasnicka', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Olson', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Makate', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003136']
1704,32763640,Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness.,"BACKGROUND


Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, including ICU-related post-traumatic stress disorder (PTSD), depression and anxiety. As we encounter a growing number of ICU survivors, in particular in the wake of the coronavirus pandemic, clinicians must be equipped to understand the severity and prevalence of significant psychiatric complications of critical illness.
METHODS


We compared the efficacy of the ICU diary, written by family and healthcare workers during the patient's intensive care course, versus education alone in reducing acute PTSD symptoms after discharge. Patients with an ICU stay >72 h, who were intubated and mechanically ventilated over 24 h, were recruited and randomized to either receive a diary at bedside with psychoeducation or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7 was conducted at baseline within 1 week of ICU discharge and at weeks 4, 12, and 24 after ICU discharge. Change from baseline in these scores was assessed using Wilcoxon rank sum tests.
RESULTS


From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital. 60 patients were enrolled and randomized, of which 35 patients completed post-discharge follow-up, (n = 18) in the diary intervention group and (n = 17) in the education-only control group. The control group had a significantly greater decrease in PTSD, hyperarousal, and depression symptoms at week 4 compared to the intervention group. There were no significant differences in other measures, or at other follow-up intervals. Both study groups exhibited clinically significant PTSD symptoms at all timepoints after ICU discharge. Follow-up phone interviews with patients revealed that while many were interested in getting follow-up for their symptoms, there were many barriers to accessing appropriate therapy and clinical attention.
CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay. However, our study finds an important gap in clinical practice - patients at high risk for PICS are infrequently connected to appropriate follow-up care. Perhaps ICU diaries would prove beneficial if utilized to support the work within a program providing wrap-around services and close psychiatric follow up for PICS patients. This study demonstrates the high prevalence of ICU-related PTSD in our cohort of survivors, the high barrier to accessing care for appropriate treatment of PICS, and the consequence of that barrier-prolonged psychological morbidity.
TRIAL REGISTRATION


NCT04305353.
GRANT IDENTIFICATION


GH-17-022 (Arnold P. Gold Foundation).",2020,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","['From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital', '60 patients', 'Patients with an ICU stay >72\u202fh, who were intubated and mechanically ventilated over 24\u202fh']","['intensive care unit (ICU) diary program', 'diary intervention group and (n\u202f=\u202f17) in the education-only control group', 'diary at bedside with psychoeducation or psychoeducation alone']","['acute PTSD symptoms', 'PTSD symptoms', 'PTSD, hyperarousal, and depression symptoms', 'Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0747767', 'cui_str': 'Acute Post-Traumatic Stress Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}]",60.0,0.0503067,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","[{'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Sayde', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: gsayde@tulane.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Stefanescu', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, 1440 Canal Street, New Orleans, LA 70122, USA. Electronic address: astefanescu@tulane.edu.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Conrad', 'Affiliation': 'Department of Psychiatry, Louisiana State University, 2025 Gravier Street, New Orleans, LA 70112, USA. Electronic address: econra@lsuhsc.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of New Mexico School of Medicine, 1 University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hammer', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: rhammer@tulane.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.017']
1705,32763649,"Parenting, mental health and economic pathways to prevention of violence against children in South Africa.","BACKGROUND


Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.
METHODS


The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.
RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.
CONCLUSIONS


Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.",2020,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","['rural South Africa with 40 sites, n\xa0=\xa0552 family dyads (including adolescents aged 10-18 and primary caregivers', 'reduced violence against children', 'Emotional and physical violence against children/adolescents', 'violence against children in South Africa', 'violence against children']","['brief informational workshop', '14-session parenting program delivered by local community members, including modules on family budgeting and savings']","['violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare', 'parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening', 'child behaviour']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",552.0,0.117351,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Institute of Criminology, University of Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meinck', 'Affiliation': 'School of Social and Political Science, University of Edinburgh, United Kingdom; Optentia, Faculty of Health Sciences, North-West University, South Africa. Electronic address: Franziska.Meinck@ed.ac.uk.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Berezin', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Applied Psychology, New York University, New York, USA. Electronic address: mnb387@nyu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Doubt', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: jennydoubt@gmail.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa. Electronic address: Catherine.Ward@uct.ac.za.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parra-Cardona', 'Affiliation': 'Steve Hicks School of Social Work, The University of Texas at Austin, Texas, USA. Electronic address: rparra@austin.utexas.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, South Africa. Electronic address: carl.lombard@mrc.ac.za.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; MRC/CSO Social and Public Health Sciences Unit, University of Glasglow, United Kingdom. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wittesaele', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: camille.wittesaele@spi.ox.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychology, University of Cape Town, South Africa. Electronic address: inge.wessels@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: frances.gardner@wolfson.ox.ac.uk.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; TUM School of Governance, Technical University of Munich, Germany. Electronic address: janina.steinert@tum.de.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113194']
1706,32763776,Effect of brief encouragement to use twitter on knowledge of the critical-care literature by ICU residents: The randomized controlled IMKREASE trial.,,2020,,['ICU residents'],[],[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],[],,0.0232695,,"[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jeanbaptiste.lascarrou@chu-nantes.fr.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Tours, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Potier', 'Affiliation': 'Department of internal medicine, University Hospital Center, Nantes, France. Electronic address: pierre.potier@chu-nantes.fr.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reignier', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jean.reignier@chu-nantes.fr.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Canet', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: emmanuel.canet@chu-nantes.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.07.022']
1707,32730613,Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.
Objective


To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.
Design, Setting, and Participants


A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.
Interventions


The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.
Main Outcomes and Measures


Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).
Results


Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]).
Conclusions and Relevance


This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","['patients with advanced heart failure, which disproportionately affects rural and minority populations', '415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals', 'Patients and Caregivers', '415 participants (221 men', ' baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n\u2009=\u2009208) or usual care (n\u2009=\u2009207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0', 'patients with advanced heart failure', 'Patients With Heart Failure']","['early palliative care telehealth intervention', 'Early Palliative Care Telehealth Intervention vs Usual Care', 'person palliative care consultation and 6 weekly nurse-coach telephonic sessions']","['mean (SE) KCCQ score', 'pain intensity and interference', 'quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS', 'global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits', 'quality of life, mood, global health, pain, and resource use', 'mood (HADS-anxiety, d\u2009', 'quality of life or mood', 'mean (SE) FACIT-Pal-14 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0441785', 'cui_str': 'Stage C'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.155537,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2861']
1708,32731812,Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-Risk Children.,"OBJECTIVE


Early adversity is correlated with increased risk for negative outcomes, including psychopathology and atypical neurodevelopment. The authors aimed to test the causal impact of an early parenting intervention (Attachment and Biobehavioral Catch-Up; ABC) on children's neural processing of parent cues and on psychosocial functioning in a longitudinal randomized clinical trial.
METHODS


Participants (N=68, mean age, 10.0 years [SD=0.8 years]) were 46 high-risk children whose parents were randomly assigned to receive either the ABC intervention (N=22) or a control intervention (N=24) while the children were infants, in addition to a comparison sample of low-risk children (N=22). During functional MRI scanning, children viewed pictures of their own mothers and of a stranger.
RESULTS


Children in the ABC condition showed greater maternal cue-related activation than children in the control condition in clusters of brain regions, including the precuneus, the cingulate gyrus, and the hippocampus, regions commonly associated with social cognition. Additionally, greater activity in these regions was associated with fewer total behavior problems. There was an indirect effect of early intervention on middle childhood psychosocial functioning mediated through increased activity in brain regions in response to maternal cues.
CONCLUSIONS


These results suggest that early parenting intervention (in this case the ABC intervention) can enhance brain regions supporting children's social cognitive development. In addition, the findings highlight these brain effects as a possible neural pathway through which ABC may prevent future behavior problems among high-risk children, yielding psychosocial benefits that endure through at least middle childhood without the need to intervene with the child directly.",2020,"RESULTS


Children in the ABC condition showed greater maternal cue-related activation than children in the control condition in clusters of brain regions, including the precuneus, the cingulate gyrus, and the hippocampus, regions commonly associated with social cognition.","['Participants (N=68, mean age, 10.0 years [SD=0.8 years]) were 46 high-risk children whose parents', 'High-Risk Children']","['early parenting intervention', 'ABC intervention', 'control intervention', 'early parenting intervention (the Attachment and Biobehavioral Catch-Up; ABC']","[""children's neural processing of parent cues"", 'maternal cue-related activation', 'Brain Responses to Maternal Cues', 'total behavior problems']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.0293274,"RESULTS


Children in the ABC condition showed greater maternal cue-related activation than children in the control condition in clusters of brain regions, including the precuneus, the cingulate gyrus, and the hippocampus, regions commonly associated with social cognition.","[{'ForeName': 'Emilio A', 'Initials': 'EA', 'LastName': 'Valadez', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}, {'ForeName': 'Nim', 'Initials': 'N', 'LastName': 'Tottenham', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Tabachnick', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park (Valadez); Department of Psychology, Columbia University, New York (Tottenham); Department of Psychological and Brain Sciences, University of Delaware, Newark (Tabachnick, Dozier).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2020.20010011']
1709,32739493,Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial.,"BACKGROUND


Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system.
METHODS


A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania. Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians.
DISCUSSION


This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.",2020,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","['Patients with advanced cancer and their caregivers are invited to enroll', 'patients with advanced cancer']","['person advance care planning (ACP) discussions versus web-based ACP', 'person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool']","['patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs', 'ACP effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.133077,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","[{'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Resick', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: jmr58@pitt.edu.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: rabob@pitt.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, USA; San Francisco Veterans Affairs Health Care System, SFVAMC 4150 Clement Street, #151R, San Francisco, CA 94121, USA. Electronic address: Rebecca.Sudore@ucsf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., 1304 Broad Street, Durham, NC 27705, USA. Electronic address: dfarrell@peopledesigns.com.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Belin', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: belin@pitt.edu.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh School of Medicine, 200 Meyran Avenue, Suite 300, Pittsburgh, PA 15213, USA. Electronic address: ada62@pitt.edu.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Division of Nursing Research and Education, Department of Population Sciences, City of Hope Medical Center, 1500 Duarte Road, Duarte, CA 91010, USA. Electronic address: BFerrell@coh.org.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Hammes', 'Affiliation': 'Respecting Choices, A Division of C-TAC Innovations, PO Box 258, Oregon, WI 53575-0258, USA. Electronic address: bhammes@respectingchoices.org.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology and Cancer Therapeutics Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: chue2@upmc.edu.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 600 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15213, USA. Electronic address: douglas.white@pitt.edu.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Rak', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 3520 Fifth Ave, Suite100, Pittsburgh, PA 15213, USA. Electronic address: kjr8@pitt.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: yas28@pitt.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106071']
1710,32739494,Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial.,"BACKGROUND


Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population.
METHODS


At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years.
RESULTS


Nearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use.
CONCLUSIONS


Personal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).",2020,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"['healthy older individuals to 100\u202fmg', 'Eligible participants were healthy, free of major diseases and expected to survive 5\u202fyears', 'healthy older ASPREE participants', 'healthy older people enrolling', 'At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n\u202f=\u202f16,703; U.S., n\u202f=\u202f2411', 'uniquely healthy older population']","['ASPirin', 'aspirin or placebo']","['Cancer history and risk factors', 'Prevalence of prostate and breast cancer history', 'Cancer prevalence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",19114.0,0.463069,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"[{'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Suzanne.orchard@monash.edu.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Jessica.lockery@monash.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, University of Melbourne,1G Royal Parade, Parkville, Victoria 3052, Australia. Electronic address: Peter.gibbs@petermac.org.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Galhina.polekhina@monash.edu.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Rory.wolfe@monash.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.zalcberg@monash.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Andrew.haydon@monash.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.mcneil@monash.edu.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St (Private Bag 23), Hobart 7000, Tasmania, Australia. Electronic address: Mark.nelson@utas.edu.au.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Kent Street, Bentley, Perth 6102, Western Australia, Australia. Electronic address: Christpher.reid@curtin.edu.au.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA. Electronic address: bkirpach@bermancenter.org.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA; Division of Geriatrics, Department of Medicine, Hennepin Healthcare and University of Minnesota, East River Parkway, Minneapolis 55455, Minnesota, USA. Electronic address: AMurray@bermancenter.org.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Robyn.woods@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106095']
1711,32739072,The effectiveness of an oral hygiene program combined with health-promoting counseling for rural adults with cardiometabolic risks: A quasi-experimental design.,"AIM


The aim of this study was to explore the effectiveness of an oral hygiene program combined with home-phone health promoting counseling for rural adults with metabolic syndrome.
BACKGROUND


Metabolic syndrome is an important risk factor for cardiometabolic diseases. Evidence indicates that the poor oral hygiene and unhealthy lifestyles are closely related to metabolic syndrome.
METHODS


A prospective quasi-experimental design involved a total of 136 community adults, with metabolic syndrome living in two rural townships, were clustered and conveniently assigned to intervention and control group between June 2017 and December 2018. The primary outcome was the change in cardiometabolic biomarkers. The secondary outcome comprised changes in the health-promoting behaviors. The intervention effect was assessed using a generalized estimating equation model.
RESULTS


There were 80 and 56 participants in the intervention and control group, respectively. The mean age was 56 years and ranged from 33 to 70 years. The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
CONCLUSION


This study supports the use of an oral hygiene program combined with home-phone counseling, which offers more advantages than its counterpart. Considering the global epidemic of cardiometabolic diseases, this is a community health nursing model worth to replicate and evaluate. Further study should consider innovative strategies to improve the awareness and adoption of a healthy lifestyle in residents with cardiometabolic risks.",2020,"The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
","['rural adults with metabolic syndrome', '136 community adults, with metabolic syndrome living in two rural townships, were clustered and conveniently assigned to intervention and control group between June 2017 and December 2018', 'The mean age was 56\u202fyears and ranged from 33 to 70\u202fyears', 'residents with cardiometabolic risks', 'rural adults with cardiometabolic risks']","['oral hygiene program combined with health-promoting counseling', 'oral hygiene program combined with home-phone counseling', 'oral hygiene program combined with home-phone health promoting counseling']","['waist circumference', 'use of dental floss', 'body fat percentage', 'body mass index', 'triglyceride level', 'regular tooth scaling', 'physical activity', 'total score of health-promoting behaviors', 'change in cardiometabolic biomarkers', 'health-promoting behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162350', 'cui_str': 'Dental floss'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0204173', 'cui_str': 'Scaling of tooth'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",136.0,0.0293092,"The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
","[{'ForeName': 'Jui-Chu', 'Initials': 'JC', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Ming-Shyan', 'Initials': 'MS', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Wen-Nan', 'Initials': 'WN', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Yunlin, Taiwan.'}, {'ForeName': 'Tung-Jung', 'Initials': 'TJ', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Mei-Yen', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Chiayi, Taiwan; School of Nursing, Chang Gung University, Taoyuan, Taiwan; Department of Cardiology, Chang Gung Memorial Hospital, Chiayi, Taiwan. Electronic address: meiyen@mail.cgust.edu.tw.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151333']
1712,32739073,A quasi-experimental study of the effect of an intervention on older stroke survivors' functionality.,,2020,,"[""older stroke survivors' functionality""]",[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],[],,0.0196864,,"[{'ForeName': 'Odete', 'Initials': 'O', 'LastName': 'Araújo', 'Affiliation': 'School of Nursing, University of Minho, Braga, Portugal; Health Sciences Research Unit, Nursing (UICISA E: UMinho), Portugal; Research Group ""Ageing C: Ageing Cluster"" - CINTESIS - Center for Health Technology and Services Research, Porto, Edifício da Biblioteca Geral (BGUM), Campus de Gualtar, 4710-057 Braga, Portugal. Electronic address: odete.araujo@ese.uminho.pt.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Lage', 'Affiliation': 'School of Nursing, University of Minho, Edifício da Biblioteca Geral (BGUM), Campus de Gualtar, 4710-057 Braga, Portugal. Electronic address: ilage@ese.uminho.pt.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cabrita', 'Affiliation': 'Faculty of Pharmacy, University of Lisbon, Avenida Professor Gama Pinto, 1649-003 Lisboa, Portugal. Electronic address: jcabrita@ff.ul.pt.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua Jorge de Viterbo Ferreira 228, 4050-343 Porto, Portugal.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151280']
1713,32747412,Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial.,"OBJECTIVE


There is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.
DESIGN


Data were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.
RESULTS


Over a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.
CONCLUSION


Aspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.
TRIAL REGISTRATION NUMBER


ASPREE. NCT01038583.",2020,"The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.
","[""primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19\u2009114) in community-dwelling persons aged ≥70 years"", 'older persons', 'older people using']","['Aspirin', 'aspirin', 'aspirin versus placebo']","['major GI bleeding that resulted in transfusion, hospitalisation, surgery or death', 'overall GI bleeding risk', 'GI bleeds', 'absolute 5-year risk of bleeding', 'smoking, hypertension, chronic kidney disease and obesity increased bleeding risk', 'bleeding overall', 'fatal bleeds', '5-year absolute risk of serious bleeding', 'Major GI bleeding', 'gastrointestinal bleeding']","[{'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",,0.488227,"The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.
","[{'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mahady', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia suzanne.mahady@monash.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Reid', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Division of Geriatrics, Department of Medicine, Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ltp', 'Initials': 'L', 'LastName': 'Thao', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.'}]",Gut,['10.1136/gutjnl-2020-321585']
1714,32748345,Advanced Notification Calls Prior to Mailed Fecal Immunochemical Test in Previously Screened Patients: a Randomized Controlled Trial.,"BACKGROUND


Phone calls as part of multimodal fecal immunochemical test (FIT) outreach are effective but resource-intensive. Previous studies of advanced notification calls before FIT mailing have not differentiated patients' prior screening status.
OBJECTIVE


To determine the effectiveness of a phone call preceding mailing of a FIT kit on test completion rate for patients who have completed a prior FIT.
DESIGN


Randomized controlled trial nested within a larger study. All patients were assigned to receive organized mailed FIT outreach in the larger study.
PARTICIPANTS


Patients in a safety-net health setting ages 50-75 years old with a previously negative FIT.
INTERVENTIONS


Patients were assigned to either receive an advanced notification phone call or no phone call preceding a mailed FIT kit. Both groups received an informational postcard prior to the mailed FIT.
MAIN MEASURES


The primary outcome was FIT completion rate at 1 year. The secondary outcomes were FIT completion rates at 60, 90, and 180 days, rates stratified by demographic subgroups, and rates according to outcome of the phone call.
KEY RESULTS


A total of 1645 patients were assigned to advanced notification calls and 1595 were assigned to no call preceding the FIT mailing. Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52). Of the patients assigned to receive an advanced notification call, 90.5% were spoken with or left a voicemail; patients who were spoken with were more likely to complete a FIT at 1 year compared with patients who were only left a voicemail or could not be left a voicemail (79.9% vs. 69.2% vs. 49.6%, p < 0.01).
CONCLUSIONS


Advanced notification phone calls prior to FIT mailing did not improve rates at 1 year for patients with a previously negative FIT.",2020,"Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52).","['patients who have completed a prior FIT', 'Previously Screened Patients', '1645 patients were assigned to advanced notification calls and 1595 were assigned to no call preceding the FIT mailing', 'Patients in a safety-net health setting ages 50-75 years old with a previously negative FIT']","['advanced notification phone call or no phone call preceding a mailed FIT kit', 'informational postcard prior to the mailed FIT', 'phone call preceding mailing of a FIT kit', 'organized mailed FIT outreach']","['FIT completion rate at 1 year', 'FIT completion rates', 'FIT completion', 'FIT completion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C2717852', 'cui_str': 'Postcards'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1300196', 'cui_str': 'Organized'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1645.0,0.113703,"Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52).","[{'ForeName': 'Briton', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Rachocki', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Issaka', 'Affiliation': 'Clinical Research & Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Shapiro', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Ladabaum', 'Affiliation': 'Division of Gastroenterology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Somsouk', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA, USA. Ma.somsouk@ucsf.edu.'}]",Journal of general internal medicine,['10.1007/s11606-020-06009-4']
1715,32749733,Cost-effectiveness of dapagliflozin as a treatment for heart failure with reduced ejection fraction: a multinational health-economic analysis of DAPA-HF.,"AIM


To estimate the cost-effectiveness of dapagliflozin added to standard therapy, vs. standard therapy only, in patients with heart failure (HF) with reduced ejection fraction (HFrEF), from the perspective of UK, German, and Spanish payers.
METHODS AND RESULTS


A lifetime Markov model was built to estimate outcomes in patients with HFrEF. Health states were defined by Kansas City Cardiomyopathy Questionnaire total symptom score, type 2 diabetes and worsening HF events. The incidence of worsening HF and all-cause mortality was estimated using negative binomial regression models and parametric survival analysis, respectively. Direct healthcare costs (2019 British pounds/Euro) and patient-reported outcomes (EQ-5D) were sourced from the existing literature and the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF), respectively; the median duration of follow-up in DAPA-HF was 18.2 months (range: 0-27.8). Future costs and effects were discounted at 3.0% for the Spanish and German analyses and 3.5% for the UK analysis. In the UK setting, treatment with dapagliflozin was estimated to increase life-years and quality-adjusted life-years (QALYs) from 5.62 to 6.20 (+0.58) and 4.13 to 4.61 (+0.48), respectively, and reduce lifetime hospitalizations for HF (925 and 820 events per 1000 patients for placebo and dapagliflozin, respectively). Similar results were obtained for Germany and Spain. The incremental cost-effectiveness ratios were £5822, €5379 and €9406/QALY in the UK, Germany and Spain, respectively. In probabilistic sensitivity analyses, more than 90% of simulations were cost-effective at a willingness-to-pay threshold of £20 000/QALY in UK and €20 000/QALY in Germany and Spain.
CONCLUSION


Dapagliflozin is likely to be a cost-effective treatment for HFrEF in the UK, German and Spanish healthcare systems.",2020,"The incremental cost-effectiveness ratios were £5,822, €5,379 and €9,406/QALY in the UK, Germany and Spain, respectively.","['heart failure with reduced ejection fraction', 'patients with HFrEF', 'patients with heart failure (HF) with reduced ejection fraction, from the perspective of UK, German, and Spanish payers', '925 and 820 events per 1,000 patients for']","['Dapagliflozin', 'dapagliflozin', 'placebo and dapagliflozin']","['incremental cost-effectiveness ratios', 'Direct healthcare costs', 'Kansas City Cardiomyopathy Total Symptom Score, type 2 diabetes and worsening HF events', 'cost-effective', 'increase life-years and quality-adjusted life-years (QALYs', 'cost-effectiveness', 'lifetime hospitalisations for HF ', 'incidence of worsening HF and all-cause mortality']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C4517904', 'cui_str': '925'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0421322,"The incremental cost-effectiveness ratios were £5,822, €5,379 and €9,406/QALY in the UK, Germany and Spain, respectively.","[{'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Darlington', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg/Saar, Germany.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Klas', 'Initials': 'K', 'LastName': 'Bergenheim', 'Affiliation': 'AstraZeneca, CVRM Biopharmaceutical, Gothenburg, Sweden.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'AstraZeneca, CVRM Biopharmaceutical, Gaithersburg, MD, USA.'}]",European journal of heart failure,['10.1002/ejhf.1978']
1716,32745667,Relationships between rectal and perirectal doses and rectal bleeding or tenesmus in pooled voxel-based analysis of 3 randomised phase III trials.,"BACKGROUND AND PURPOSE


This study aimed to identify anatomically-localised regions where planned radiotherapy dose is associated with gastrointestinal toxicities in healthy tissues throughout the pelvic anatomy.
MATERIALS AND METHODS


Planned dose distributions for up to 657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset. Voxel-based multiple comparison permutation dose difference testing, Cox regression modelling and LASSO feature selection were used to identify regions where dose-increase was associated with grade ≥2 rectal bleeding (RB) or tenesmus, according to the LENT/SOMA scale. This was externally validated by registering dose distributions from the RT01 (n = 388) and CHHiP (n = 241) trials onto the same exemplar and repeating the tests on each of these data sets, and on all three datasets combined.
RESULTS


Voxel-based Cox regression and permutation dose difference testing revealed regions where increased dose was correlated with gastrointestinal toxicity. Grade ≥2 RB was associated with posteriorly extended lateral beams that manifested high doses (>55 Gy) in a small rectal volume adjacent to the clinical target volume. A correlation was found between grade ≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
CONCLUSIONS


The serial response of the rectum with respect to RB has been demonstrated in patients with posteriorly extended lateral beams. Similarly, the parallel response of the PRFS with respect to tenesmus has been demonstrated in patients treated with the posterior beam.",2020,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
","['patients with posteriorly extended lateral beams', '657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset']",[],"['grade≥2 rectal bleeding (RB) or tenesmus', 'gastrointestinal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",[],"[{'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0232726', 'cui_str': 'Rectal tenesmus'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}]",,0.0350618,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia. Electronic address: 20739859@student.uwa.edu.au.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; CSIRO, Herston, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Crawley, Australia; 5D Clinics, Claremont, Australia; GenesisCare WA, Wembley, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, United Kingdom; Department of Medical Physics and Biomedical Engineering, University College London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, Australia.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia; 5D Clinics, Claremont, Australia.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.07.048']
1717,32746598,[Effects of desflurane and sevoflurane anesthesia on postoperative recovery after long-term tumor surgery].,"Objective:  To analyze the effects of desflurane and sevoflurane anesthesia on postoperative recovery after long lasting tumor surgery.  Methods:  One hundred and sixty patients undergoing endoscopic radical esophagectomy and gastrectomy (80 cases of each surgical type) from November 2019 to March 2020 at Henan Cancer Hospital, were randomized into 4 groups( n= 40): group CS (esophageal cancer+sevoflurane anesthesia), group DS (esophageal cancer+desflurane anesthesia),group CW (stomach cancer+sevoflurane anesthesia) and group DW (gastric cancer+desflurane anesthesia). General anesthesia was induced by intravenous agents in all four groups, which were maintained by inhaled anesthetic during the operation. The mean arterial pressure (MAP), heart rate (HR), and surplus pulse O(2) (SpO(2)) immediately before induction (T(1)), the moment of operation begin (T(2)), operation end (T(3)) and extubation (T(4)) were recorded. Also, the duration required for inhalation anesthetic alveolar concentration reaching 0.5 minimum alveolar concentration (MAC) during induction, the alveolar anesthetic concentration at the beginning of the operation, the duration required for XMAC (patients specific alveolar concentration) declining to 0.5 MAC on recovery period, and the duration of alveolar concentration of 0.5 MAC declining to 0.2 MAC were determined. Additionally, the durations of spontaneous breathing recovery, eyes opening, extubation and recovery of consciousness were recorded. Finally, restlessness score (RS) during recovery period was used to evaluate postoperative agitation.  Results:  Compared with group CS and group CW, no significant differences in MAP, HR, SpO(2) in group DS and group DW at T(1) to T(4) were found (all  P> 0.05). The durations required for inhalation anesthetic alveolar concentration reaching 0.5 MAC were (5.6±1.3), (5.8±2.1), (3.5±1.5) and (3.8±1.0) min in group CS, group CW, group DS and group DW, where the durations in group DS and group DW were significantly shorter than those in group CS and group CW ( F= 32.538,  P< 0.05). The durations of alveolar concentration of 0.5 MAC declining to 0.2 MAC were (6.4±2.2), (7.0±1.5), (4.2±2.2) and (4.1±1.5) min in group CS, group CW, group DS and group DW, and the durations in group DS and group DW were significantly shortened as compared with group CS and group CW ( F= 42.113,  P< 0.05). Compared with group CS and group CW, group DS and group DW required significantly shorter time for spontaneous breathing recovery, eye opening,extubation, and directional force recovery after operation (all  P< 0.05).  Conclusions:  Both desflurane and sevoflurane anesthesia can achieve satisfactory anesthesia depth during long lasting tumor surgery. Desflurane can shorten the recovery time and early extubation, and improve the quality of recovery.",2020,"Compared with group CS and group CW, no significant differences in MAP, HR, SpO(2) in group DS and group DW at T(1) to T(4) were found (all  P> 0.05).","['80 cases of each surgical type) from November 2019 to March 2020 at Henan Cancer Hospital', 'after long-term tumor surgery', 'One hundred and sixty patients undergoing']","['CS (esophageal cancer+sevoflurane anesthesia), group DS (esophageal cancer+desflurane anesthesia),group CW (stomach cancer+sevoflurane anesthesia) and group DW (gastric cancer+desflurane anesthesia', 'desflurane and sevoflurane anesthesia', 'endoscopic radical esophagectomy and gastrectomy', 'Desflurane']","['duration of alveolar concentration', 'durations required for inhalation anesthetic alveolar concentration reaching 0.5 MAC', 'restlessness score (RS', 'postoperative recovery', 'duration required for inhalation anesthetic alveolar concentration reaching 0.5 minimum alveolar concentration (MAC) during induction, the alveolar anesthetic concentration', 'MAP, HR, SpO(2', 'shorter time for spontaneous breathing recovery, eye opening,extubation, and directional force recovery', 'recovery time and early extubation', 'durations of alveolar concentration of 0.5 MAC declining to 0.2 MAC', 'satisfactory anesthesia depth', 'mean arterial pressure (MAP), heart rate (HR), and surplus pulse O(2) (SpO(2)) immediately before induction (T(1)), the moment of operation begin (T(2)), operation end (T(3)) and extubation (T(4', 'quality of recovery', 'durations of spontaneous breathing recovery, eyes opening, extubation and recovery of consciousness']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}]",160.0,0.01659,"Compared with group CS and group CW, no significant differences in MAP, HR, SpO(2) in group DS and group DW at T(1) to T(4) were found (all  P> 0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Cancer Hospital, Fudan University, Shanghai 200032, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200422-01273']
1718,32753874,Cardiovascular Protection Variables Based on Exercise Intensity in Stable Coronary Heart Disease Patients After Coronary Stenting: A Comparative Study.,"Purpose


Our study aimed at determining and comparing the mechanism of cardiovascular protection variables in moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) in patients with stable coronary heart disease (CHD) after coronary stenting.
Participants and Methods


This experimental study used the same subject and cross-over design, involving eleven stable CHD patients after coronary stenting. These were randomly divided into two groups; MICT for 29 minutes at 50-60% heart rate reserve and HIIT with 4x4 minute intervals at 60-80% heart rate reserve, each followed by three minutes of active recovery at 40-50% heart rate reserve. These were conducted three times a week for two weeks. The participants' levels of adrenaline, noradrenaline, endothelial nitric oxide synthase (eNOS), extracellular superoxide dismutase (EC-SOD) activity assayed, and flow-mediated dilatation (FMD) were examined before and after treatments were completed.
Results


The HIIT significantly increased the levels of noradrenaline and eNOS compared with MICT (p<0.05). Also, HIIT was better in maintaining EC-SOD activity and FMD compared with MICT (p<0.05). Through the noradrenalin pathway, HIIT had a direct and significant effect on eNOS and FMD (p<0.05) but MICT, through the noradrenaline pathways, had a direct and significant effect on eNOS (p<0.05), and through the EC-SOD activity pathways had a direct and significant effect on FMD (p<0.05). MICT reduced EC-SOD activity and also decreased the FMD value.
Conclusion


HIIT is superior to MICT in increasing cardiovascular protection by increasing the concentrations of noradrenalin and eNOS, maintaining EC-SOD activity, and FMD in stable CHD patients after coronary stenting.",2020,The HIIT significantly increased the levels of noradrenaline and eNOS compared with MICT (p<0.05).,"['eleven stable CHD patients after coronary stenting', 'stable CHD patients after coronary stenting', 'Stable Coronary Heart Disease Patients', 'Participants and Methods', 'patients with stable coronary heart disease (CHD) after coronary stenting', 'moderate']","['MICT', 'intensity continuous training (MICT) and high-intensity interval training (HIIT']","['FMD value', 'eNOS and FMD', 'maintaining EC-SOD activity and FMD', 'adrenaline, noradrenaline, endothelial nitric oxide synthase (eNOS), extracellular superoxide dismutase (EC-SOD) activity assayed, and flow-mediated dilatation (FMD', 'levels of noradrenaline and eNOS', 'concentrations of noradrenalin and eNOS, maintaining EC-SOD activity, and FMD', 'MICT reduced EC-SOD activity']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",11.0,0.0275147,The HIIT significantly increased the levels of noradrenaline and eNOS compared with MICT (p<0.05).,"[{'ForeName': 'Dyana', 'Initials': 'D', 'LastName': 'Sarvasti', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine Widya Mandala Catholic University, Surabaya, Indonesia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Lalenoh', 'Affiliation': 'Department of Cardiology, Siloam Hospital TB Simatupang, Jakarta, Indonesia.'}, {'ForeName': 'Emanoel', 'Initials': 'E', 'LastName': 'Oepangat', 'Affiliation': 'Department of Cardiology, Siloam Hospital TB Simatupang, Jakarta, Indonesia.'}, {'ForeName': 'Budhi Setianto', 'Initials': 'BS', 'LastName': 'Purwowiyoto', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Santoso', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine University of Indonesia National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Rochmad', 'Initials': 'R', 'LastName': 'Romdoni', 'Affiliation': 'Department of Cardiology and Vascular Medicine, Faculty of Medicine Airlangga University - Dr. Soetomo District General Hospital, Surabaya, Indonesia.'}]",Vascular health and risk management,['10.2147/VHRM.S259190']
1719,32757702,The Effect of Metalinguistic Sentence Combining on Eighth-Grade Students' Understanding and Written Expression of Comparison and Contrast in Science.,"Purpose The purpose of this study was to examine whether sentence combining with an explicit metalinguistic approach in comparison to typical science instruction was effective in improving written expression and understanding of comparison/contrast in science for eighth-grade students who struggle with literacy. Method Eighty-four eighth-grade students who struggle with literacy participated in this study. The experimental group ( n  = 36) received the writing intervention of metalinguistic sentence combining (MSC) during their science class for a total of 400 min (20 intervention sessions, 20 min each), while the comparison group ( n  = 48) participated in their typical science instruction. Total science instruction time was held constant for both groups. All students completed pretests and posttests to determine an increase in (a) syntactic factors of academic science text such as longer sentence length and use of syntactic forms of connectives, targeted connectives, left embeddedness, and agentless passive voice when responding to a science compare and contrast writing prompt; and (b) listing similarities and differences between two science concepts on a graphic organizer. Results Treatment was effective in improving the experimental group's score in listing similarities and differences between two science concepts on a graphic organizer. There were no significant differences between the two groups in their use of syntactic factors typical of academic text when responding to a science compare and contrast writing prompt. Conclusions MSC was effective in improving the experimental student's ability to demonstrate understanding of comparison and contrast in science. Modifications to the MSC intervention may yield better results in the experimental group's posttreatment writing in future studies. Supplemental Material https://doi.org/10.23641/asha.12735950.",2020,There were no significant differences between the two groups in their use of syntactic factors typical of academic text when responding to a science compare and contrast writing prompt.,"['Method Eighty-four eighth-grade students who struggle with literacy participated in this study', 'for eighth-grade students who struggle with literacy']","['Metalinguistic Sentence', 'writing intervention of metalinguistic sentence combining (MSC', 'academic science text such as longer sentence length and use of syntactic forms of connectives, targeted connectives, left embeddedness, and agentless passive voice when responding to a science compare and contrast writing prompt', 'MSC intervention', 'typical science instruction']","['Total science instruction time', 'written expression and understanding of comparison/contrast in science']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]",84.0,0.0210589,There were no significant differences between the two groups in their use of syntactic factors typical of academic text when responding to a science compare and contrast writing prompt.,"[{'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Telesca', 'Affiliation': 'Department of Communication Disorders, State University of New York at New Paltz.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Ehren', 'Affiliation': 'Student Success Initiatives, Inc., Anna Maria, Student Success Initiatives, Inc., Anna Maria, FL.'}, {'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Hahs-Vaughn', 'Affiliation': 'Department of Learning Sciences and Educational Research, University of Central Florida, Orlando.'}, {'ForeName': 'Vassiliki Vicky I', 'Initials': 'VVI', 'LastName': 'Zygouris-Coe', 'Affiliation': 'School of Teacher Education, University of Central Florida, Orlando.'}, {'ForeName': 'Anthony Pak-Hin', 'Initials': 'AP', 'LastName': 'Kong', 'Affiliation': 'School of Communication Sciences and Disorders, University of Central Florida, Orlando.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-19-00086']
1720,32768993,The relationship between insomnia and the intensity of drinking in treatment-seeking individuals with alcohol dependence.,"BACKGROUND


Although insomnia is highly prevalent in alcohol use disorders(AUD), its associations with the severity of alcohol use, pre-existing psychiatric comorbidities and psychosocial problems are understudied. The present study evaluates the interplay between these factors using a structural equation model (SEM).
METHODS


We assessed baseline cross-sectional data on patients with AUD (N = 123) recruited to a placebo-controlled medication trial. Severity of alcohol use was measured by the Brief Michigan Alcoholism Screening Test (B-MAST). Insomnia Severity Index was used to assess insomnia symptoms. The Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively. We used logistic regression to evaluate the association between insomnia and severity of alcohol use while controlling for covariates. We constructed a SEM with observed variables to delineate the effect of psychiatric symptoms, psychosocial factors and current alcohol use on the pathway between alcohol use severity and insomnia.
RESULTS


The sample was predominately male(83.9 %), Black(54.6 %) and employed(60.0 %). About 45 % of the participants reported moderate-severe insomnia.The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] = 1.17(0.99-1.47). SEM findings demonstrated that B-MAST and insomnia were linked to psychiatric symptoms (95 % Asymptotic-Confidence Interval (ACI): 0.015-0.159, p < 0.05) but not to psychosocial problems or current alcohol use.
CONCLUSION


Among treatment-seeking patients with AUD, psychiatric burden mediated the relationship between severity of alcohol use and insomnia. Clinicians should screen for underlying psychiatric disorders among treatment-seeking patients with AUD complaining of insomnia.",2020,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","['patients with AUD (N = 123) recruited to a placebo-controlled medication trial', 'treatment-seeking patients with AUD', 'treatment-seeking patients with AUD complaining of insomnia', 'treatment-seeking individuals with alcohol dependence']",[],"['Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively', 'Insomnia Severity Index', 'insomnia symptoms', 'psychiatric symptoms', 'moderate-severe insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439022', 'cui_str': 'Complaining of insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",123.0,0.022062,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","[{'ForeName': 'Ninad S', 'Initials': 'NS', 'LastName': 'Chaudhary', 'Affiliation': 'University of Alabama at Birmingham School of Public Health, 1665 University Blvd, Birmingham, AL, 35211, USA. Electronic address: ninadsc@uab.edu.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wong', 'Affiliation': 'Idaho State University, 921 S 8th Ave, Stop 8112, Pocatello, ID, 83209, USA.'}, {'ForeName': 'Bhanu Prakash', 'Initials': 'BP', 'LastName': 'Kolla', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, 2nd ST SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Subhajit', 'Initials': 'S', 'LastName': 'Chakravorty', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA. Electronic address: Subhajit.Chakravorty@uphs.upenn.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108189']
1721,32769165,Correction:  Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study .,,2020,,['advanced cervical cancer'],"['anti-angiogenesis therapy', 'chemotherapy with bevacizumab']",[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0253617,,[],International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000869corr1']
1722,32771678,Gamma transcranial alternating current stimulation improves mood and cognition in patients with major depression.,"Major depression is one of the most common psychiatric disorders with a high rate of treatment resistance where new treatment options are urgently warranted. One of these new options are non-invasive brain stimulation techniques like transcranial magnetic or electric stimulation. One of the latter is transcranial Alternating Current Stimulation (tACS) in various frequencies. Here, we report a case series of six patients suffering from major depression treated with tACS in gamma (40 Hz) frequency. Patients were randomized to two groups, receiving either two 10-min stimulations (group 1) or a 20-min stimulation or per day (group 2) over ten days. Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2). Results also showed an improvement in cognitive functions assessed by word fluency and n-back test. It is hypothesized that gamma tACS could help to synchronize disturbed frequency bands in frontal and prefrontal cortex areas and thus restore dysbalanced neural connectivity in psychiatric disorders.",2020,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","['six patients suffering from major depression treated with tACS in gamma (40\xa0Hz) frequency', 'patients with major depression']","['Gamma transcranial alternating current stimulation', 'transcranial Alternating Current Stimulation (tACS', 'gamma tACS']","['Hamilton Depression Rating Scale and Beck Depression Inventory', 'cognitive functions assessed by word fluency and n-back test', 'mood and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0221377,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","[{'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Senner', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Institute of Psychiatric Phenomics and Genomics (IPPG), Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of Sao Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Bernau, Felden, Germany. Electronic address: u.palm@medicalpark.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.009']
1723,32771909,Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa.,"BACKGROUND


South Africa has the highest HIV prevalence globally, which disproportionately affects women. Hazardous alcohol use reduces antiretroviral adherence which can lead to adverse health. Few evidence-based interventions addressing hazardous alcohol use and HIV have been implemented in real-world settings. This study aimed to evaluate implementation outcomes from the Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town.
METHODS


We conducted this implementation science trial using a modified stepped-wedge design. Four health clinics were paired with four substance use rehabilitation programs and randomized into four cycles. Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle). We assessed adoption, acceptability, appropriateness, cost, and fidelity using a mixed methods approach.
RESULTS


Adoption: 100 % of staff trained in the WHC and designated as interventionists delivered one or more workshops. Acceptability: Interventionists found the WHC content beneficial to their patients and the WHC improved connections between clinical units in facilities. Appropriateness: The WHC aligned with facility goals to improve antiretroviral adherence and reduce alcohol use; however, there were implementation challenges, including staff shortages, stigma, and few places to refer women for supportive services. Cost: The cost of implementing the WHC was 20.59 ZAR (1.40 USD) per attendee. Fidelity: Interventionists implemented the WHC with high fidelity and quality.
CONCLUSIONS


The findings suggest it is feasible to integrate the WHC into usual-care settings. Future efforts to scale up the intervention will need to address social and structural implementation challenges.
TRIAL REGISTRATION


NCT02733003 approved 1/21/2016.",2020,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[""Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town"", 'usual-care settings in South Africa', 'Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle', 'Four health clinics']",['gender-focused HIV and alcohol risk-reduction intervention'],"['Acceptability', 'Fidelity', 'adoption, acceptability, appropriateness, cost, and fidelity', 'antiretroviral adherence', 'Cost', 'cost of implementing the WHC']","[{'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}]",,0.0625822,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[{'ForeName': 'Margaret W', 'Initials': 'MW', 'LastName': 'Gichane', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA; Department of Psychology, North Carolina State University, 2310 Katharine Stinson Drive Raleigh, Raleigh, NC, 27607, USA; Psychiatry and Behavioral Sciences, Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC, 27710, USA. Electronic address: wmw@rti.org.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ndirangu', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Brittni', 'Initials': 'B', 'LastName': 'Howard', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Zule', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108206']
1724,32744184,Pregnancy outcomes among women born in Somalia and Sweden giving birth in the Stockholm area - a population-based study.,"BACKGROUND


Studies report that women born in some African countries, after migrating to the Nordic countries, have worse pregnancy outcomes than women born in the receiving countries. With the aim of identifying unmet needs among Somali-born women, we here study this subgroup.
OBJECTIVE


We compared pregnancy outcomes among women born in Somalia to women born in Sweden. Further, we investigated whether the proactive maternal observation of fetal movements has effects on birth outcomes among women born in Somalia.
METHODS


In Stockholm, half of the maternity clinics were randomized to intervention, in which midwives were instructed to be proactive towards women by promoting daily self-monitoring of fetal movements. Data for 623 women born in Somalia and 26 485 born in Sweden were collected from a population-based register.
RESULTS


An Apgar score below 7 (with stillbirth counting as 0) at 5 minutes was more frequent in babies of women born in Somalia as compared to babies of women born in Sweden (RR 2.17, 95% CI 1.25-3.77). Babies born small for gestational age were more common among women born in Somalia (RR 2.22, CI 1.88-2.61), as were babies born after 41 + 6 gestational weeks (RR 1.65, CI 1.29-2.12). Somali-born women less often contacted obstetric care for decreased fetal movements than did Swedish-born women (RR 0.19, CI 0.08-0.36). The differences between women born in Somalia and women born in Sweden were somewhat lower (not statistically significant) among women allocated to proactivity as compared to the Routine-care group.
CONCLUSIONS


A higher risk of a negative outcome for mother and baby is seen among women born in Somalia compared to women born in Sweden. We suggest it may be worthwhile to investigate whether a Somali-adapted intervention with proactivity concerning self-monitoring of fetal movements may improve pregnancy outcomes in this migrant population.",2020,"The differences between women born in Somalia and women born in Sweden were somewhat lower (not statistically significant) among women allocated to proactivity as compared to the Routine-care group.
","['women born in Somalia and Sweden giving birth in the Stockholm area - a population-based study', '623 women born in Somalia and 26 485 born in Sweden were collected from a population-based register', 'women born in Somalia', 'women born in Somalia to women born in Sweden', 'women born in Somalia compared to women born in Sweden', 'Somali-born women', 'women born in some African countries']",['proactive towards women by promoting daily self-monitoring of fetal movements'],"['Pregnancy outcomes', 'Apgar score', 'fetal movements']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1277513', 'cui_str': 'Born in Somalia'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1277386', 'cui_str': 'Born in Sweden'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0337847', 'cui_str': 'Somalis'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0454695', 'cui_str': 'African country'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015946', 'cui_str': 'Fetal movement activity'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0015946', 'cui_str': 'Fetal movement activity'}]",,0.0919175,"The differences between women born in Somalia and women born in Sweden were somewhat lower (not statistically significant) among women allocated to proactivity as compared to the Routine-care group.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Akselsson', 'Affiliation': 'Department of Health Promoting Science, Sophiahemmet University , Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindgren', 'Affiliation': ""Department of Women and Children's Health, Karolinska Institutet , Stockholm, Sweden.""}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Georgsson', 'Affiliation': 'The Swedish Red Cross University College , Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Pettersson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet , Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Skokic', 'Affiliation': 'Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg , Gothenburg, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Rådestad', 'Affiliation': 'Department of Health Promoting Science, Sophiahemmet University , Stockholm, Sweden.'}]",Global health action,['10.1080/16549716.2020.1794107']
1725,32739495,Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis.,"BACKGROUND/AIMS


Despite high mortality of alcohol-associated hepatitis, there has been limited advancement in treatment strategies. Defeat Alcoholic Steatohepatitis (DASH) is a multicenter, randomized, double-blind controlled trial whose primary objective was to evaluate the safety and efficacy of a novel combination of 3 drugs targeting different perturbations in AH.
METHODS


Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score ≥ 20 stratified by MELD scores (20-25 and ≥ 26) and randomized to a combination of an interleukin receptor 1 antagonist, Anakinra(100 mg daily for 14 days) to suppress acute inflammation, pentoxifylline (400 mg three times a day for 28 days) to prevent hepatorenal syndrome, and zinc sulfate (220 mg orally once daily for 6 months) or the standard of care therapy including methylprednisolone 32 mg orally once daily for 28 days. The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
RESULTS


Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6 ± 3.2 (20.0-35.0) in the investigational arm and 25.8 ± 4.5 (20.0-40.0) in the standard of care arm. Causes of screen failures included not meeting eligibility criteria (n = 347), declining to participate (n = 39), and other reasons (n = 10).
CONCLUSIONS


Data from the DASH consortium studies will determine if a combination of drugs targeting multiple mechanisms of injury in the severe AH will improve clinical outcomes.",2020,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","['Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6\u202f±\u202f3.2 (20.0-35.0) in the investigational arm and 25.8\u202f±\u202f4.5 (20.0-40.0) in the standard of care arm', 'Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score\u202f≥']","['interleukin receptor 1 antagonist, Anakinra(100\u202fmg daily for 14\u202fdays) to suppress acute inflammation, pentoxifylline', 'zinc sulfate (220\u202fmg orally once daily for 6\u202fmonths) or the standard of care therapy including methylprednisolone']","['safety and efficacy', 'unadjusted log-rank test of the Kaplan-Meier survival estimates']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0206553', 'cui_str': 'Interleukin Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0333361', 'cui_str': 'Acute inflammation'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",104.0,0.725088,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","[{'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Cleveland Clinic, USA. Electronic address: dasaras@ccf.org.'}, {'ForeName': 'Mack C', 'Initials': 'MC', 'LastName': 'Mitchell', 'Affiliation': 'University of Texas at Southwestern University, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'University of Massachusetts, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'University of Louisville, USA.'}, {'ForeName': 'Gyongyi', 'Initials': 'G', 'LastName': 'Szabo', 'Affiliation': 'Harvard Medical School & Beth Israel Deaconess Medical Center, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Nagy', 'Affiliation': 'Cleveland Clinic, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Radaeva', 'Affiliation': 'National Institute of Alcohol Abuse and Alcoholism, USA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Cleveland Clinic, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106094']
1726,32739548,ERAS protocol with respiratory prehabilitation versus conventional perioperative protocol in elective gastrectomy- a randomized controlled trial.,"BACKGROUND


Several studies have investigated the efficacy of enhanced recovery programs in patients undergoing gastrectomy. The role of prehabilitation in these programs has not been evaluated in this subset of patients. This study incorporated incentive spirometry as a type of respiratory prehabilitation in the Enhanced Recovery After Surgery (ERAS) protocol for gastrectomy.
METHODS


In this single-center, prospective, open-labeled randomized controlled trial, 58 patients were randomized into two groups - a conventional perioperative care group and an ERAS group. The patients in the ERAS group received a supervised regimen of preoperative volume-oriented incentive spirometry as respiratory prehabilitation in addition to other ERAS care elements. The length of hospitalization (LOH) was assessed as the primary outcome, while the postoperative peak expiratory flow rate (PEFR) and the incidence of surgical and pulmonary complications were the secondary outcomes.
RESULTS


The patients in the ERAS group had a shorter median LOH compared to the conventional group (11 days vs 13 days, p = 0.003). The patients in the ERAS group also had smaller fall in postoperative PEFR from baseline, which was significant on the second postoperative day (p = 0.011). None of the patients were found to have anastomotic leaks. The incidence of surgical complications was comparable between the groups (p = 0.137).
CONCLUSION


ERAS protocol reduced the duration of hospitalization without increasing the complications compared to conventional perioperative protocol. Respiratory prehabilitation in the form of a supervised schedule of incentive spirometry helped in the preservation of lung functions in the postoperative period.",2020,"The patients in the ERAS group had a shorter median LOH compared to the conventional group (11 days vs 13 days, p = 0.003).","['patients undergoing gastrectomy', '58 patients']","['supervised regimen of preoperative volume-oriented incentive spirometry as respiratory prehabilitation in addition to other ERAS care elements', 'conventional perioperative care group and an ERAS']","['postoperative PEFR', 'length of hospitalization (LOH', 'incidence of surgical complications', 'postoperative peak expiratory flow rate (PEFR) and the incidence of surgical and pulmonary complications', 'anastomotic leaks', 'shorter median LOH', 'duration of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0524869', 'cui_str': 'Heterozygosity, Loss of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",58.0,0.0386538,"The patients in the ERAS group had a shorter median LOH compared to the conventional group (11 days vs 13 days, p = 0.003).","[{'ForeName': 'Nagalakshmi', 'Initials': 'N', 'LastName': 'Swaminathan', 'Affiliation': 'Department of Anaesthesiology & Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kundra', 'Affiliation': 'Department of Anaesthesiology & Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India. Electronic address: p_kundra@hotmail.com.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Ravi', 'Affiliation': 'Department of Anaesthesiology & Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.027']
1727,32740192,Dexmedetomidine Sedation in Mechanically Ventilated Critically Ill Children: A Pilot Randomized Controlled Trial.,"OBJECTIVES


To assess the feasibility, safety, and efficacy of a sedation protocol using dexmedetomidine as the primary sedative in mechanically ventilated critically ill children.
DESIGN


Open-label, pilot, prospective, multicenter, randomized, controlled trial. The primary outcome was the proportion of sedation scores in the target sedation range in the first 48 hours. Safety outcomes included device removal, adverse events, and vasopressor use. Feasibility outcomes included time to randomization and protocol fidelity.
SETTING


Six tertiary PICUs in Australia and New Zealand.
PATIENTS


Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours.
INTERVENTIONS


Children randomized to dexmedetomidine received a dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1). Children randomized to usual care received sedation as determined by the treating clinician (but not dexmedetomidine), also targeted to light sedation.
MEASUREMENTS AND MAIN RESULTS


Sedation with dexmedetomidine as the primary sedative resulted in a greater proportion of sedation measurements in the light sedation range (State Behavioral Scale -1 to +1) over the first 48 hours (229/325 [71%] vs 181/331 [58%]; p = 0.04) and the first 24 hours (66/103 [64%] vs 48/116 [41%]; p < 0.001) compared with usual care. Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements. Median time to randomization after intubation was 6.0 hours (interquartile range, 2.0-9.0 hr) in the dexmedetomidine arm compared with 3.0 hours (interquartile range, 1.0-7.0 hr) in the usual care arm (p = 0.24).
CONCLUSIONS


A sedation protocol using dexmedetomidine as the primary sedative was feasible, appeared safe, achieved early, light sedation, and reduced midazolam requirements. The findings of this pilot study justify further studies of sedative agents in critically ill children.",2020,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"['Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours', 'Mechanically Ventilated Critically Ill Children', 'critically ill children', 'Six tertiary PICUs in Australia and New Zealand', 'mechanically ventilated critically ill children']","['dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1', 'Dexmedetomidine Sedation', 'dexmedetomidine', 'usual care received sedation as determined by the treating clinician (but not dexmedetomidine']","['hypotension and bradycardia', 'proportion of sedation scores', 'feasibility, safety, and efficacy', 'proportion of sedation measurements', 'light sedation range (State Behavioral Scale -1 to +1', 'time to randomization and protocol fidelity', 'device removal, adverse events, and vasopressor use', 'Cumulative midazolam dosage', 'Median time to randomization after intubation']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0752250', 'cui_str': 'Removal of device'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.154635,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Erickson', 'Affiliation': ""Paediatric Critical Care, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': ""Paediatric Intensive Care Unit, Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Paediatric Intensive Care Unit, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Marino S', 'Initials': 'MS', 'LastName': 'Festa', 'Affiliation': ""Kids Critical Care Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Lahn', 'Initials': 'L', 'LastName': 'Straney', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Debbie A', 'Initials': 'DA', 'LastName': 'Long', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002483']
1728,32741502,Oxytocin-enhanced group therapy for methamphetamine use disorder: Randomized controlled trial.,"BACKGROUND


Methamphetamine (METH) use is a public health crisis that disproportionately affects men who have sex with men (MSM). There are currently no FDA-approved pharmacological interventions to treat methamphetamine use disorder (MUD). MUD is associated with social impairments and extremely high treatment attrition rates. Administration of oxytocin, a neuropeptide involved in social attachment, may be a novel approach to addressing these issues. Moreover, oxytocin administration has shown promise for reducing METH-related addictive behavior in animal models, but has not yet been investigated in clinical trials for MUD. Last, oxytocin is known to modulate stress responsivity via regulation of the autonomic nervous system, which is dysregulated in METH users. We hypothesize that oxytocin, in combination with group psychotherapy, will increase treatment engagement, reduce addiction behavior, and mitigate stress hyperreactivity.
METHODS


This is a randomized, double blind trial of oxytocin 40-IU (n = 24) or placebo (n = 24) administered intranasally prior to each of six weekly motivational interviewing group therapy (MIGT) sessions for MUD in MSM.
PRIMARY OUTCOME


(a) session attendance.
SECONDARY OUTCOMES


(b) group cohesion, (c) anxiety, (d) METH craving, (e) METH use, and (f) in-session cardiac physiology.
RESULTS


Participants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014. There was a small effect of oxytocin on group cohension, but not anxiety or craving. METH use did not change over the six-week MIGT course in either treatment arm. Participants receiving oxytocin had lower average heart rates during MIGT sessions and higher heart rate variability. There were positive main effects of MIGT over Time regardless of study drug.
CONCLUSIONS


This evidence, and the lack of any serious adverse events, suggests that oxytocin may safely increase treatment attendance. One possible mechanism by which it may do so is its modulation of the autonomic nervous system. Further investigation is warranted.",2020,"RESULTS


Participants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014.","['methamphetamine use disorder', 'men who have sex with men (MSM']","['motivational interviewing group therapy (MIGT) sessions for MUD in MSM', 'oxytocin', 'oxytocin 40-IU (n\xa0=\xa024) or placebo', 'MIGT', 'Methamphetamine (METH', 'Oxytocin-enhanced group therapy', 'placebo']","['addiction behavior', 'b) group cohesion, (c) anxiety, (d) METH craving', 'therapy attendance', 'average heart rates', 'heart rate variability', 'anxiety or craving', 'a) session attendance']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.674374,"RESULTS


Participants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014.","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America; Portland Veterans Affairs Medical Center & Oregon Health and Science University, United States of America. Electronic address: christopher.stauffer@va.gov.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Moschetto', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McKernan', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Meinzer', 'Affiliation': 'Slalom Consulting, LLC, United States of America.'}, {'ForeName': 'Chavy', 'Initials': 'C', 'LastName': 'Chiang', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rapier', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hsiang', 'Affiliation': 'University of California, San Francisco, United States of America.'}, {'ForeName': 'Jerika', 'Initials': 'J', 'LastName': 'Norona', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borsari', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108059']
1729,32746948,Television advertisements for high-sugar foods and beverages: effect on children's snack food intake.,"Energy-dense food advertising affects children's eating behaviour. However, the impact of high-sugar food advertising specifically on the intake of sweet foods is underexplored. This study sought to determine whether children would increase their intake of sugar and total energy following high-sugar food advertising (relative to toy advertising) and whether dental health, weight status and socio-economic status (SES) would moderate any effect. In a crossover, randomised controlled trial, 101 UK children (forty male) aged 8-10 years were exposed to high-sugar food/beverage and toy advertisements embedded within a cartoon. Their subsequent intake of snack foods and beverages varying in sugar content was measured. A dental examination was performed, and height and weight measurements were taken. Home postcode provided by parents was used to assign participants to SES quintiles. Children consumed a significantly greater amount of energy (203·3 (95 % CI 56·5, 350·2) kJ (48·6 (95 % CI 13·5, 83·7) kcal); P = 0·007) and sugar (6·0 (95 % CI 1·3, 10·7) g; P = 0·012) following food advertisements compared with after toy advertisements. This was driven by increased intake of the items with most sugar (chocolate and jelly sweets). Children of healthy weight and with dental caries had the greatest intake response to food advertising exposure, but there were no differences by SES. Acute experimental food advertising exposure increases food intake in children. Specifically, high-sugar food and beverage advertising promotes the consumption of high-sugar food items. The debate around the negative health effects of food advertising on children should be widened to include dental health as well as overall dietary health and obesity.",2020,"Children consumed a significantly greater amount of energy (48.6kcal, 95% CI 13.5-83.7, p=0.007) and sugar (6.0g, 95% CI 1.3 to 10.7, p=0.012) following food advertisements compared with after toy advertisements.","['children', ""children's snack food intake"", 'Children of healthy weight and with dental caries', '101 UK children (40 male) aged 8-10 years', ""children's eating behaviour""]",['high sugar food/beverage and toy advertisements embedded within a cartoon'],"['intake of sugar, and total energy', 'sugar content', 'amount of energy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]","[{'cui': 'C0453865', 'cui_str': 'Sweet food'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0007306', 'cui_str': 'Cartoons'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",101.0,0.124295,"Children consumed a significantly greater amount of energy (48.6kcal, 95% CI 13.5-83.7, p=0.007) and sugar (6.0g, 95% CI 1.3 to 10.7, p=0.012) following food advertisements compared with after toy advertisements.","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Kearney', 'Affiliation': 'Department of Orthodontics, Liverpool University Dental Hospital, LiverpoolL3 5PS, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Orthodontics, Liverpool University Dental Hospital, LiverpoolL3 5PS, UK.'}, {'ForeName': 'Girvan', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Department of Biostatistics, University Liverpool, LiverpoolL69 3BX, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Higham', 'Affiliation': 'School of Dentistry, University of Liverpool, LiverpoolL69 7ZT, UK.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Flannigan', 'Affiliation': 'Department of Orthodontics, Liverpool University Dental Hospital, LiverpoolL3 5PS, UK.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'Department of Psychology, University of Liverpool, LiverpoolL69 7ZA, UK.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Boyland', 'Affiliation': 'Department of Psychology, University of Liverpool, LiverpoolL69 7ZA, UK.'}]",The British journal of nutrition,['10.1017/S0007114520003116']
1730,32746952,Cocoa-rich chocolate and body composition in postmenopausal women: a randomised clinical trial.,"During menopause, women undergo a series of physiological changes that include a redistribution of fat tissue. This study was designed to investigate the effect of adding 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women daily on body composition. We conducted a 6-month, two-arm randomised, controlled trial. Postmenopausal women (57·2 (sd 3·6) years, n 132) were recruited in primary care clinics. Participants in the control group (CG) did not receive any intervention. Those of the intervention group (IG) received 10 g daily of 99 % cocoa chocolate in addition to their habitual diet for 6 months. This quantity comprises 247 kJ (59 kcal) and 65·4 mg of polyphenols. The primary outcomes were the between-group differences in body composition variables, measured by impendancemetry at the end of the study. The main effect of the intervention showed a favourable reduction in the IG with respect to the CG in body fat mass (-0·63 kg (95 % CI -1·15, -0·11), P = 0·019; Cohen's d = -0·450) and body fat percentage (-0·79 % (95 % CI -1·31, -0·26), P = 0·004; Cohen's d = -0·539). A non-significant decrease was also observed in BMI (-0·20 kg/m2 (95 % CI -0·44, 0·03), P = 0·092; Cohen's d = -0·345). Both the body fat mass and the body fat percentage showed a decrease in the IG for the three body segments analysed (trunk, arms and legs). Daily addition of 10 g of cocoa-rich chocolate to the habitual diet of postmenopausal women reduces their body fat mass and body fat percentage without modifying their weight.",2020,"Both the body fat mass and the body fat percentage showed a decrease in the IG for the 3 body segments analysed (trunk, arms and legs).","['postmenopausal women', 'Postmenopausal women (57.2±3.6 years, n = 132) were recruited in primary care clinics', 'postmenopausal women daily on body composition']","['polyphenols', 'cocoa-rich chocolate', 'Cocoa-rich chocolate', '99%-cocoa chocolate']","['body fat percentage', 'body mass index', 'body composition variables', 'body fat mass and body fat percentage without modifying their weight', 'body fat mass']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",132.0,0.0920202,"Both the body fat mass and the body fat percentage showed a decrease in the IG for the 3 body segments analysed (trunk, arms and legs).","[{'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Garcia-Yu', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACYL), 37005Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACYL), 37005Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACYL), 37005Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACYL), 37005Salamanca, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lugones-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACYL), 37005Salamanca, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernandez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACYL), 37005Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACYL), 37005Salamanca, Spain.'}]",The British journal of nutrition,['10.1017/S0007114520003086']
1731,32749173,"Assessing the analgesic efficacy of oral epigallocatechin-3-gallate on epidural catheter analgesia in patients after surgical stabilisation of multiple rib fractures: a prospective double-blind, placebo-controlled clinical trial.","CONTEXT


Thoracic trauma results in multiple rib fractures (MRF), and surgical stabilisation of rib fractures (SSRF) can relieve fracture pain. Epigallocatechin-3-gallate (EGCG) is reported to exhibit beneficial effects in bone-related metabolic and differentiation processes.
OBJECTIVE


To study the clinical effect of EGCG on regional analgesia for pain relief in MRF patients after SSRF.
MATERIALS AND METHODS


Ninety-seven MRF patients (61 males, 36 females) who were on epidural catheter analgesia after SSRF were recruited. They were randomly divided into: oral EGCG 100 mg (oral grade) twice daily for 10 days and placebo groups. Pain scores, incentive spirometry (IS) volumes, respiratory rate and oxygen saturation (SpO 2 ) were assessed day 10 after SSRF.
RESULTS


Comparing results from the placebo and EGCG group, in the 10-day intervention course, oral EGCG reduced pain score (8 at base line vs. 4 at end of intervention in EGCG group,  p  < 0.05; 4 in EGCG group vs. 6 in placebo group at end of intervention,  p  < 0.05), improved IS volume (713 at base line vs. 1072 at end of intervention in EGCG group,  p  < 0.05; 1072 in EGCG group vs. 953 in placebo group at end of intervention,  p  < 0.05) and respiratory rate (24 at base line vs. 15 at end of intervention in EGCG group,  p  < 0.05; 15 in EGCG group vs. 19 in placebo group at end of intervention,  p  < 0.05). However, no further enhancing effect on SpO 2  was observed in the EGCG group (0.98 in EGCG group vs. 0.98 in placebo group at end of intervention,  p  > 0.05).
DISCUSSION AND CONCLUSIONS


Although the study is limited by a relatively small sample size and lack of serum factor analysis, the key results and the study design, for the first time, nevertheless pave the way for trials with larger number of patients to understand the effect of EGCG in MRF patients that are undergoing SSRF.",2020,"However, no further enhancing effect on SpO 2  was observed in the EGCG group (0.98 in EGCG group vs. 0.98 in placebo group at end of intervention,  p  > 0.05).
","['patients after surgical stabilisation of multiple rib fractures', 'Ninety-seven MRF patients (61 males, 36 females) who were on epidural catheter analgesia after SSRF were recruited', 'MRF patients after SSRF']","['EGCG', 'oral EGCG 100\u2009mg (oral grade) twice daily for 10\u2009days and placebo', 'oral epigallocatechin-3-gallate', 'placebo and EGCG', 'Epigallocatechin-3-gallate (EGCG', 'epidural catheter analgesia', 'placebo']","['pain relief', 'SpO 2', 'oral EGCG reduced pain score', 'analgesic efficacy', 'respiratory rate', 'Pain scores, incentive spirometry (IS) volumes, respiratory rate and oxygen saturation (SpO 2 ', 'IS volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0272567', 'cui_str': 'Fracture of multiple ribs'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}]","[{'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",97.0,0.0849642,"However, no further enhancing effect on SpO 2  was observed in the EGCG group (0.98 in EGCG group vs. 0.98 in placebo group at end of intervention,  p  > 0.05).
","[{'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Hefan', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, Fujian Medical University, Quanzhou, China.'}]",Pharmaceutical biology,['10.1080/13880209.2020.1797123']
1732,32745891,Automatic Imitation in Comorbid PTSD & Alcohol Use Disorder and Controls: an RCT of Intranasal Oxytocin.,"INTRODUCTION


Mimicking movements of others makes both the imitating and imitated partners feel closer. Oxytocin may increase focus on others and has been shown to increase automatic imitation in healthy controls (HC). However, this has not been replicated, and oxytocin's effects on automatic imitation have not been demonstrated in clinical populations. This study attempts to replicate effects on HC and examine effects on people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD).
METHODS


Fifty-four males with PTSD-AUD and 43 male HC received three intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU) in a randomized order, across three separate testing days, as part of a double-blind, crossover parent study. At 135 min post-administration, each performed the imitation-inhibition task, which quantifies automatic imitation as the congruency effect (CE). After exclusions, the final analyzed data set included 49 participants with PTSD-AUD and 38 HC.
RESULTS


In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase. In PTSD-AUD, oxytocin did not significantly increase CE. Post-hoc analysis showed the PTSD-AUD group had higher CE than HC on placebo visits.
DISCUSSION


Our data suggest PTSD-AUD is associated with higher automatic imitation than HC in the absence of oxytocin administration. We successfully replicated findings that oxytocin increases automatic imitation in HC. This demonstrates an unconscious motor effect induced by oxytocin, likely relevant to more complex forms of imitative movements, which have the potential to improve social connection. We did not find a significant effect of oxytocin on automatic imitation in PTSD-AUD. Future research should examine imitation in both sexes, at peak oxytocin levels, and on increasingly complex forms of imitation.",2020,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","['49 participants with PTSD-AUD and 38 HC', 'Fifty-four males with PTSD-AUD and 43 male HC', 'people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD', 'healthy controls (HC']","['intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU', 'oxytocin', 'Intranasal Oxytocin', 'Oxytocin']","['CE', 'automatic imitation']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0439453', 'cui_str': 'IU'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]",49.0,0.0522705,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","[{'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: morrisont@gmail.com.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: lize.decoster@gmail.com.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Christopher.Stauffer@ucsf.edu.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: jin.wen2100@gmail.com.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ahmadi', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: elnaz.ahmadi@gmail.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: Kevin.Delucchi@ucsf.edu.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Aoife.ODonovan@ucsf.edu.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Josh.Woolley@ucsf.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104787']
1733,32749877,"Understanding of Perceived Infectiousness and Its Influence on Sexual Behavior Among Individuals With Acute HIV Infection in Lilongwe, Malawi (HPTN 062).","We implemented HPTN 062, an acceptability and feasibility study of a motivational-interviewing (MI) intervention to reduce HIV transmission among individuals with acute HIV infection (AHI) in Lilongwe, Malawi. Participants were randomly assigned to receive either brief education or the MI intervention over 24 weeks; all participants received the same messages about AHI. We used mixed methods to assess participants' understanding of the association between AHI and viral load, and its connection to sexual behavior at 8 weeks. While most participants understood key aspects of AHI, MI-intervention participants gave substantially more detailed descriptions of their understanding. Nearly all participants, regardless of study arm, understood that they were highly infectious and would be very likely to transmit HIV after unprotected sex during AHI. Our findings suggest that messages about AHI delivered during the period of AHI are likely beneficial for ensuring that those with AHI understand their level of infectiousness and its association with forward transmission.",2020,"Nearly all participants, regardless of study arm, understood that they were highly infectious and would be very likely to transmit HIV after unprotected sex during AHI.","['Individuals With Acute HIV Infection in Lilongwe, Malawi', 'individuals with acute HIV infection (AHI) in Lilongwe, Malawi']","['brief education or the MI intervention', 'motivational-interviewing (MI) intervention']",['Sexual Behavior'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0343752', 'cui_str': 'Acute HIV infection'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0351249,"Nearly all participants, regardless of study arm, understood that they were highly infectious and would be very likely to transmit HIV after unprotected sex during AHI.","[{'ForeName': 'Tiarney D', 'Initials': 'TD', 'LastName': 'Ritchwood', 'Affiliation': 'Department of Family Medicine and Community Health, School of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Massa', 'Affiliation': 'UNC Project Lilongwe, Lilongwe, Malawi.'}, {'ForeName': 'Gift', 'Initials': 'G', 'LastName': 'Kamanga', 'Affiliation': 'FHI 360, Lilongwe, Malawi.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Corneli', 'Affiliation': 'Department of Population Health Sciences, School of Medicine, Duke University, and the Duke Clinical Research Institute, Duke University.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2020.32.3.260']
1734,32751640,Short-Term Compound Training on Physical Performance in Young Soccer Players.,"This study aimed to investigate the effects of a five-week compound training (with strength and plyometric exercises performed on separate days) on sprint, change of direction, and vertical jump in young soccer players. Eighteen novices in strength and plyometric training were assigned to either a compound training (CMPT) or a control condition (CNT). Both groups trained three times per week. One session was dedicated to soccer-specific drills. The other two weekly sessions were dedicated to circuit-based training routines employing on one-day strength exercises and on the other day plyometric exercises in the CMPT group. At the same time, the CNT group performed two weekly soccer-specific training sessions. All players were tested by 15-m sprint, change-of-direction and acceleration test (CODAT), squat jump, and countermovement jump with arms swing tests. CMPT group improved CODAT, squat jump and countermovement jump to a higher extent compared to CNT group (large vs small or trivial effects,  p  < 0.05), while both groups had similar 15-m sprint performance ( p  > 0.05). These results support the use of compound training to improve change of direction and vertical jump performances in young novice soccer players, which are unfamiliar with structured and advanced strength and plyometric training.",2020,"CMPT group improved CODAT, squat jump and countermovement jump to a higher extent compared to CNT group (large vs small or trivial effects,  p  < 0.05), while both groups had similar 15-m sprint performance ( p  > 0.05).","['Eighteen novices in strength and plyometric training', 'young soccer players', 'Young Soccer Players', 'young novice soccer players']","['compound training (CMPT) or a control condition (CNT', 'five-week compound training (with strength and plyometric exercises', 'CMPT', 'CNT', 'Short-Term Compound Training']","['15-m sprint, change-of-direction and acceleration test (CODAT), squat jump, and countermovement jump with arms swing tests', 'change of direction and vertical jump performances', '15-m sprint performance', 'Physical Performance', 'CODAT, squat jump and countermovement jump']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.00854369,"CMPT group improved CODAT, squat jump and countermovement jump to a higher extent compared to CNT group (large vs small or trivial effects,  p  < 0.05), while both groups had similar 15-m sprint performance ( p  > 0.05).","[{'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Trecroci', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20129 Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20129 Milan, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Formenti', 'Affiliation': 'Department of Biotechnology and Life Sciences (DBSV), University of Insubria, 21100 Varese, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20129 Milan, Italy.'}, {'ForeName': 'F Marcello', 'Initials': 'FM', 'LastName': 'Iaia', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20129 Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20129 Milan, Italy.'}]","Sports (Basel, Switzerland)",['10.3390/sports8080108']
1735,32755831,"An android smartphone-based randomized intervention improves the quality of life in patients with type 2 diabetes in Mysore, Karnataka, India.","BACKGROUND AND AIMS


Associated with severe complications and morbidity, Diabetes Mellitus is a significant public health burden. The need for regular monitoring and adherence to treatment and lifestyle changes have a high impact on the quality of life of the patients. This study attempts to assess the effect of smartphone-based lifestyle modification intervention in the quality of life of patients with type 2 Diabetes through a randomized filed trial.
METHODS


A randomized field trial was performed among the patients attending the outpatient department of a tertiary care hospital in Mysuru city. A mobile application named DIAGURU, mainly focusing on the lifestyle modification and medication management was used for a period of 6 months from April 2019 to September 2019 by 150 patients in the intervention group while another 150 participants served as controls. The quality of life was assessed using the WHO QOL BREF questionnaire at the beginning of the study and after six months.
RESULTS


The change in the quality of life in a positive direction was significantly higher in the intervention group compared to the non-intervention group after six months. The differences in the change in scores of quality of life of participants recruited in intervention and non-intervention groups were statistically significant in all the four domains after the intervention with a p value < 0.001.
CONCLUSION


The evidence generated in this study suggest that such technological approaches can be used as a public health measure to improve the quality of life of patients with type 2 Diabetes Mellitus.",2020,The change in the quality of life in a positive direction was significantly higher in the intervention group compared to the non-intervention group after six months.,"['patients with type 2 diabetes in Mysore, Karnataka, India', 'patients with type 2 Diabetes Mellitus', 'patients attending the outpatient department of a tertiary care hospital in Mysuru city', 'patients with type 2 Diabetes']","['smartphone-based lifestyle modification intervention', 'android smartphone-based randomized intervention']","['quality of life', 'quality of life in a positive direction', 'WHO QOL BREF questionnaire', 'scores of quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336541', 'cui_str': 'Android'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0470927,The change in the quality of life in a positive direction was significantly higher in the intervention group compared to the non-intervention group after six months.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sunil Kumar', 'Affiliation': 'Department of Community Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Prakash', 'Affiliation': 'Department of Community Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Subhash Chandra', 'Affiliation': 'Department of General Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India.'}, {'ForeName': 'Padma Shrinivas', 'Initials': 'PS', 'LastName': 'Kadkol', 'Affiliation': 'Department of Information Science & Engineering, JSS S&T University (Formally SJCE), Mysuru, India.'}, {'ForeName': 'Vanishri', 'Initials': 'V', 'LastName': 'Arun', 'Affiliation': 'Department of Information Science & Engineering, JSS S&T University (Formally SJCE), Mysuru, India.'}, {'ForeName': 'Jose Jom', 'Initials': 'JJ', 'LastName': 'Thomas', 'Affiliation': 'Department of Community Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, India. Electronic address: josejom031@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.07.025']
1736,32755838,"Impact of patient education on KAP, medication adherence and therapeutic outcomes of metformin versus insulin therapy in patients with gestational diabetes: A Hospital based pilot study in South India.","BACKGROUND AND AIM


The study assessed the impact of continuous patient education on Knowledge, Attitude, Practice (KAP), medication adherence and extent of glycemic control in pregnant women with gestational diabetes on insulin or metformin therapy.
METHODS


81 women with gestational diabetes (37 on insulin and 44 on metformin) were assessed for KAP using a validated questionnaire and medication adherence using the 8-items Morisky medication adherence scale, fasting, and postprandial blood glucose levels at the baseline and after two education sessions on drug therapy at one and three months intervals. The difference in mean KAP, medication adherence scores, fasting, and postprandial blood glucose levels and the extent of glycemic control with insulin or metformin therapy were assessed statistically.
RESULTS


There was a highly significant difference in the mean KAP, medication adherence scores, fasting and postprandial blood glucose levels from baseline to follow-up after three months, (P < 0.0001) indicating that continuous patient education had a positive impact on their KAP, medication adherence, blood glucose levels.
CONCLUSION


The study identified that continuous patient education improved their knowledge and practice of medication adherence which reflected on lowered fasting and postprandial blood glucose levels. Glycemic control was found to be the same with metformin and insulin in gestational diabetes.",2020,"There was a highly significant difference in the mean KAP, medication adherence scores, fasting and postprandial blood glucose levels from baseline to follow-up after three months, (P < 0.0001) indicating that continuous patient education had a positive impact on their KAP, medication adherence, blood glucose levels.
","['patients with gestational diabetes', '81 women with gestational diabetes (37 on insulin and 44 on', 'pregnant women with gestational diabetes on insulin or metformin therapy', 'South India']","['metformin and insulin', 'metformin', 'metformin versus insulin therapy']","['Morisky medication adherence scale, fasting, and postprandial blood glucose levels', 'Knowledge, Attitude, Practice (KAP), medication adherence and extent of glycemic control', 'KAP, medication adherence, blood glucose levels', 'lowered fasting and postprandial blood glucose levels', 'knowledge and practice of medication adherence', 'mean KAP, medication adherence scores, fasting, and postprandial blood glucose levels and the extent of glycemic control with insulin or metformin therapy', 'mean KAP, medication adherence scores, fasting and postprandial blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",81.0,0.0210953,"There was a highly significant difference in the mean KAP, medication adherence scores, fasting and postprandial blood glucose levels from baseline to follow-up after three months, (P < 0.0001) indicating that continuous patient education had a positive impact on their KAP, medication adherence, blood glucose levels.
","[{'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Krishnakumar', 'Affiliation': 'Sri Ramachandra Institute of Higher Education and Research (Deemed to Be University), India.'}, {'ForeName': 'Yeswanth', 'Initials': 'Y', 'LastName': 'Govindarajulu', 'Affiliation': 'Sri Ramachandra Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to Be University), India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Vishwanath', 'Affiliation': 'Department of Obstetrics and Gynecology, Sri Ramachandra Institute of Higher Education and Research (Deemed to Be University), India.'}, {'ForeName': 'Vanitha Rani', 'Initials': 'VR', 'LastName': 'Nagasubramanian', 'Affiliation': 'Department of Pharmacy Practice, Sri Ramachandra Institute of Higher Education and Research (Deemed to Be University), Porur, Chennai, Tamil Nadu, India. Electronic address: vanitharani.n@sriramachandra.edu.in.'}, {'ForeName': 'Thennarasu', 'Initials': 'T', 'LastName': 'Palani', 'Affiliation': 'Department of Pharmacy Practice, Sri Ramachandra Institute of Higher Education and Research (Deemed to Be University), Porur, Chennai, Tamil Nadu, India.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.07.026']
1737,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1738,32777104,Adverse Effects of High-Dose Vitamin D Supplementation on Volumetric Bone Density Are Greater in Females than Males.,"Three years of high-dose vitamin D supplementation (400 IU, 4000 IU, 10,000 IU) in healthy vitamin D-sufficient individuals aged 55 to 70 years (serum 25(OH)D 30-125 nmol/L at baseline), resulted in a negative dose-response relationship for bone density and strength. This study examined whether response differed between males and females. A total of 311 participants (53% male) were randomized to 400 IU (male = 61, female = 48), 4000 IU (male = 51, female = 49), or 10,000 IU (male = 53, female = 49) daily vitamin D 3  . Participants were scanned with high-resolution peripheral quantitative computed tomography (HR-pQCT) to measure total volumetric BMD (TtBMD) at baseline, 6, 12, 24, and 36 months. Finite element analysis estimated bone strength. Balance, physical function, and clinical biochemistry parameters were also assessed. Constrained linear mixed effects models determined time-by-treatment group-by-sex interactions. Baseline, 3-month, and 3-year levels of 25(OH)D were 76.3, 76.7, and 77.4 nmol/L (400 IU); 81.3, 115.3, and 132.2 (4000 IU); and 78.4, 188.0, and 144.4 (10,000 IU), respectively. There were significant time-by-treatment group-by-sex interactions for TtBMD at the radius (p = .002) and tibia (p = .005). Treatment with 4000 IU or 10,000 IU compared to 400 IU resulted in TtBMD losses in females, but this was not observed with males. After 3 years, females lost 1.8% (400 IU), 3.8% (4000 IU), and 5.5% (10,000 IU), whereas males lost 0.9% (400 IU), 1.3% (4000 IU), and 1.9% (10,000 IU) at the radius. At the tibia, losses in TtBMD were smaller, but followed a similar trend. There were no significant bone strength interactions. Vitamin D supplementation with 4000 IU or 10,000 IU, compared with 400 IU daily, resulted in greater losses of TtBMD over 3 years in healthy vitamin D-sufficient females, but not males. These results are clinically relevant, because vitamin D supplementation is widely administered to postmenopausal females for osteoporosis prevention. Our findings do not support a benefit of high-dose vitamin D supplementation for bone health, and raise the possibility of harm for females. © 2020 American Society for Bone and Mineral Research (ASBMR).",2020,"Vitamin D supplementation with 4000 or 10,000 IU, compared with 400 IU daily, resulted in greater losses of TtBMD over three years in healthy vitamin D-sufficient females, but not males.","['311 participants (53% male', '400, 4000, 10,000 IU) in healthy vitamin D-sufficient individuals aged 55-70\u2009years (serum 25(OH)D 30-125 nmol/L at baseline), resulted in a negative dose-response relationship for bone density and strength', 'females than males', 'postmenopausal females for osteoporosis prevention', 'males and females']","['vitamin D supplementation', 'Vitamin D supplementation']","['TtBMD losses', 'volumetric bone density', 'bone strength interactions', 'losses of TtBMD', 'Balance, physical function, and clinical biochemistry parameters', 'total volumetric BMD (TtBMD']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C3650929', 'cui_str': 'Prevention of osteoporosis'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.222451,"Vitamin D supplementation with 4000 or 10,000 IU, compared with 400 IU daily, resulted in greater losses of TtBMD over three years in healthy vitamin D-sufficient females, but not males.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Burt', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Emma O', 'Initials': 'EO', 'LastName': 'Billington', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Rose', 'Affiliation': 'Research Facilitation, Alberta Health Services, Calgary, AB, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kremer', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolism, McGill University and McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hanley', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Boyd', 'Affiliation': 'McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4152']
1739,32738837,"Efficacy and Safety of a Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin Compared with Linezolid for Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Openlabel, Randomized Study.","Background


Levonadifloxacin is a novel broad-spectrum anti-MRSA agents belonging to the benzoquinolizine subclass of quinolone. It is developed for oral or intravenous administration for the treatment of infections caused by Gram-positive organisms including methicillin-resistant Staphylococcus aureus (MRSA).
Objectives


To establish the non-inferiority of levonadifloxacin compared with linezolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and to compare the safety of the two antimicrobials.
Subjects and methods


This was a Phase 3, multicentre, randomized, open-label, active- comparator study with 500 subjects. Oral levonadifloxacin 1000 mg was compared with oral linezolid 600 mg whereas IV levonadifloxacin 800mg was compared with IV linezolid 600 mg, each treatment was administered twice daily for 7-10 days. Non-inferiority was evaluated by comparing oral levonadifloxacin to oral linezolid and IV levonadifloxacin to IV linezolid for overall clinical response at TOC (Test of Cure) Visit.
Results


The clinical cure rates observed at the TOC in the mITT (modified Intent to treat) populations for levonadifloxacin was numerically higher compared to linezolid in the IV sub-group [(91.0% verses 87.8%); treatment difference of 3.2% (95%CI, -4.5 to 10.9)] and in the oral sub-group (95.2% versus 93.6%); treatment difference of 1.6 % [95%CI, -4.2 to 7.3]). As the lowerbound of the 95% CI around the treatment difference was greater than -15% for both subgroups, the primary objective of the study was met. Therefore, both IV levonadifloxacin and oral levonadifloxacin were non-inferior to IV linezolid and oral linezolid, respectively. The majority of subjects in the micro-ITT population had a baseline infection caused by S. aureus with approximately 30% of subjects having MRSA. Levonadifloxacin (IV and oral) had a higher clinical cure rate at TOC for MRSA patients compared with linezolid (IV and oral), (95.0% vs. 89.3% respectively). Levonadifloxacin showed evidence of favourable clinical and microbiological efficacy in subjects with concurrent bacteraemia as well as in subjects with diabetes including diabetic foot infections caused by Gram-positive pathogens including MRSA. Pharmacokinetic analysis showed that bioavailability of oral levonadifloxacin was 90% and similar pharmacokinetic profile of levonadifloxacin by both routes provide an option for IV to oral switch for the treatment of subjects. Incidences of treatment-emergent adverse events (TEAEs) were similar between treatment groups and between IV (20.8% vs. 22.4%, for levonadifloxacin and linezolid, respectively) and oral therapy (16.0% vs. 13.5%, respectively), There were no SAEs or deaths related to study drug and the majority of the AEs observed were mild in nature. Overall, the administration of both IV and oral levonadifloxacin was well-tolerated in subjects with ABSSSI.
Conclusions


The results demonstrate that IV and oral levonadifloxacin therapy has excellent clinical activity against MRSA and offers advantage compared to other quinolones which generally lack MRSA coverage. Levonadifloxacin is safe and well tolerated in the treatment of ABSSSI caused by Gram -positive pathogens including MRSA as well as non-inferior to IV and oral linezolid, respectively. Similar pharmacokinetic profile of IV and oral levonadifloxacin provides an option for IV to oral switch for the treatment of subjects. Both oral and IV levonadifloxacin have recently been granted approval in India for the treatment of ABSSSI including diabetic foot infections and concurrent bacteraemia in adults (18 years of age or older). ClinicalTrials.gov Registration: NCT03405064. CTRI No.: CTRI/2017/06/008843.",2020,"Levonadifloxacin (IV and oral) had a higher clinical cure rate at TOC for MRSA patients compared with linezolid (IV and oral), (95.0% vs. 89.3% respectively).","['subjects with ABSSSI', 'adults (18 years of age or older', '500 subjects', 'acute bacterial skin and skin structure infections (ABSSSI', 'subjects', 'Subjects and methods']","['linezolid and oral linezolid', 'oral linezolid 600 mg whereas IV levonadifloxacin', 'levonadifloxacin and oral levonadifloxacin', 'linezolid and IV levonadifloxacin to IV linezolid', 'Linezolid', 'levonadifloxacin', 'Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin', 'Levonadifloxacin', 'IV and oral levonadifloxacin', 'linezolid', 'Oral levonadifloxacin']","['Efficacy and Safety', 'favourable clinical and microbiological efficacy', 'Incidences of treatment-emergent adverse events (TEAEs', 'clinical cure rate', 'bioavailability of oral levonadifloxacin', 'clinical cure rates']","[{'cui': 'C4552483', 'cui_str': 'ABSSSI'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0663241', 'cui_str': 'linezolid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1127473', 'cui_str': 'linezolid 600 MG'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0343401', 'cui_str': 'Methicillin resistant Staphylococcus aureus infection'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",,0.0470759,"Levonadifloxacin (IV and oral) had a higher clinical cure rate at TOC for MRSA patients compared with linezolid (IV and oral), (95.0% vs. 89.3% respectively).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mastim', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutte', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joshi', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kumbhar', 'Affiliation': 'Wockhardt Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Periasamy', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Palwe', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chavan', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bhagwat', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Wockhardt R and D Centre, Aurangabad, Maharashtra.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Llorens', 'Affiliation': ""Wockhardt's Morton Grove Pharmaceuticals Inc., Morton Grove, Illinois, USA.""}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Friedland', 'Affiliation': ""Wockhardt's Morton Grove Pharmaceuticals Inc., Morton Grove, Illinois, USA.""}]",The Journal of the Association of Physicians of India,[]
1740,31887537,Outcomes based on age in the phase III METEOR trial of cabozantinib versus everolimus in patients with advanced renal cell carcinoma.,"BACKGROUND


Cabozantinib improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared with everolimus in patients with advanced renal cell carcinoma (RCC) after prior antiangiogenic therapy in the phase III METEOR trial (NCT01865747). Limited data are available on the use of targeted therapies in older patients with advanced RCC.
METHODS


Efficacy and safety in METEOR were retrospectively analysed for three age subgroups: <65 (n = 394), 65-74 (n = 201) and ≥75 years (n = 63).
RESULTS


PFS, OS and ORR were improved with cabozantinib compared with everolimus in all age subgroups. The PFS hazard ratios (HRs) were 0.53 (95% confidence interval [CI]: 0.41-0.68), 0.53 (95% CI: 0.37-0.77) and 0.38 (95% CI: 0.18-0.79) for <65, 65-74 and ≥75 years, respectively, and the OS HRs were 0.72 (95% CI: 0.54-0.95), 0.66 (95% CI: 0.44-0.99) and 0.57 (95% CI: 0.28-1.14). The ORR for cabozantinib versus everolimus was 15% vs 5%, 21% vs 2% and 19% vs 0%, respectively. No significant differences were observed in PFS or OS with age as a categorical or continuous variable. Grade III/IV adverse events (AEs) were generally consistent across subgroups, although fatigue, hypertension and hyponatraemia occurred more frequently in older patients treated with cabozantinib. Dose reductions to manage AEs were more frequent in patients receiving cabozantinib than in those receiving everolimus. Dose reductions and treatment discontinuation due to AEs were more frequent in older patients in both treatment groups.
CONCLUSIONS


Cabozantinib improved PFS, OS and ORR compared with everolimus in previously treated patients with advanced RCC, irrespective of age group, supporting use in all age categories. Proactive dose modification and supportive care may help to mitigate AEs in older patients while maintaining efficacy.",2020,"RESULTS


PFS, OS and ORR were improved with cabozantinib compared with everolimus in all age subgroups.","['patients with advanced renal cell carcinoma', 'three age subgroups: <65 (n\xa0=\xa0394), 65-74 (n\xa0=\xa0201) and ≥75 years (n\xa0=\xa063', 'patients with advanced renal cell carcinoma (RCC) after prior', 'older patients', 'older patients with advanced RCC']","['everolimus', 'antiangiogenic therapy', 'cabozantinib versus everolimus']","['PFS, OS\xa0and ORR', 'fatigue, hypertension and hyponatraemia', 'PFS hazard ratios (HRs', 'progression-free survival (PFS), overall survival (OS) and objective response rate (ORR', 'ORR', 'PFS or OS', 'PFS, OS and ORR', 'Grade III/IV adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.167333,"RESULTS


PFS, OS and ORR were improved with cabozantinib compared with everolimus in all age subgroups.","[{'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark. Electronic address: Frede.Donskov@auh.rm.dk.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Voog', 'Affiliation': 'Centre Jean Bernard Clinique Victor Hugo, Le Mans, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hovey', 'Affiliation': 'Nelune Comprehensive Cancer Centre, Prince of Wales Hospital, Randwick, Australia.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Grüllich', 'Affiliation': 'National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Nott', 'Affiliation': 'Royal Hobart Hospital, Hobart, Australia.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Cuff', 'Affiliation': 'Princess Alexandra Hospital, Woolloongabba, Australia.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gil', 'Affiliation': 'Institute Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Niels Viggo', 'Initials': 'NV', 'LastName': 'Jensen', 'Affiliation': 'Odense Universitetshospital, Odense, Denmark.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Institut Universitaire Du Cancer Toulouse, Toulouse, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Negrier', 'Affiliation': 'Université Claude Bernard Lyon 1, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Depenbusch', 'Affiliation': 'Onkologische Schwerpunktpraxis Gütersloh, Gütersloh, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Bergmann', 'Affiliation': 'Universitätsklinik Frankfurt Hospital, Frankfurt, Germany.'}, {'ForeName': 'Izzy', 'Initials': 'I', 'LastName': 'Cornelio', 'Affiliation': 'Exelixis, Alameda, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Champsaur', 'Affiliation': 'Exelixis, Alameda, CA, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Sumanta', 'Initials': 'S', 'LastName': 'Pal', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.032']
1741,32750626,Association of patient preferences on medication discussion in hypertension: Results from a randomized clinical trial.,"Patient-centered care has received significant attention and is an integral component of high-quality healthcare. While it is often assumed that most prefer a patient-centered role orientation, such preferences exist along a continuum with some patients preferring a more provider-centered role. The present study examines patient preference data from a randomized clinical trial designed to test the efficacy of a patient activation intervention to promote thiazide prescribing for veteran patients with uncontrolled hypertension. Patient preferences for involvement in healthcare were assessed using the 9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS). The primary aim was to examine differences in discussion of thiazide use in the clinical encounter by those scoring high versus low on the PPOS. Five hundred ninety-five veteran patients were randomized to either one of three intervention groups or a usual care control group. The adjusted odds ratios (OR) for the three intervention groups relative to the control group indicated that thiazide discussion increased as a function of intervention intensity across both high and low PPOS groups. ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients. Results suggest that this patient activation intervention is effective for veteran patients representing a range of preferred involvement. Consideration of such preferences may be useful in tailoring future interventions in the healthcare context.",2020,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","['Five hundred ninety-five veteran patients', 'veteran patients with uncontrolled hypertension', 'hypertension']","['patient activation intervention', 'thiazide prescribing', 'thiazide', 'activation intervention', 'usual care control group']","['9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS', 'adjusted odds ratios (OR', 'function of intervention intensity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",595.0,0.0335965,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Department of Behavioral Sciences & Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA. Electronic address: matthew.howren@med.fsu.edu.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA; Department of Psychological & Brain Sciences, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Christensen', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kaboli', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113244']
1742,32761500,"Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study.","BACKGROUND


Botulinum toxin (BTX) is a potent neurotoxin with a long history of therapeutic application in neurological and dermatological conditions, with a strong efficacy and safety profile.
OBJECTIVE


Our aim was to assess whether intradermal injection with BTX-B is an effective treatment for hidradenitis suppurativa (HS).
METHODS


Twenty patients with HS stage I-III disease, according to Hurley's classification, were consecutively included for treatment with either a placebo or BTX-B. At the next intervention after 3 months, all participants received the active substance and another follow-up at 6 months. The primary outcome was quality of life, measured using the Dermatology Life Quality Index (DLQI), while secondary outcomes were the visual analogue scale (VAS) for pain in the worst boil and HS-related impairment of general health (VAS), as well as changes in physician-reported disease activity assessed as the number of total lesions, and reported adverse effects of treatment.
RESULTS


The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05). Improvement of the patients' own ratings of symptoms and a reduction in total lesions supplemented the primary outcome. Fifty-five percent of the study population reported some degree of hyperhidrosis.
CONCLUSION


BTX-B improves the quality of life in patients with HS. Furthermore, comorbidity between HS and hyperhidrosis is suggested.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03103074.",2020,"The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05).","[""Twenty patients with HS stage I-III disease, according to Hurley's classification, were consecutively included for treatment with either a"", 'patients with HS', 'Hidradenitis Suppurativa']","['placebo or BTX-B', 'Placebo', 'Botulinum toxin (BTX', 'Botulinum Toxin Type B', 'BTX-B', 'intradermal injection with BTX-B', 'placebo']","['DLQI', 'quality of life', 'visual analogue scale (VAS) for pain in the worst boil and HS-related impairment of general health (VAS), as well as changes in physician-reported disease activity assessed as the number of total lesions, and reported adverse effects of treatment', 'quality of life, measured using the Dermatology Life Quality Index (DLQI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0006051', 'cui_str': 'Botulinum Toxin Type B'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0242301', 'cui_str': 'Furuncle'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.500004,"The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05).","[{'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Grimstad', 'Affiliation': 'Department of Dermatology, University Hospital of North Norway, Tromsö, Norway. oystein.grimstad@unn.no.'}, {'ForeName': 'Bjørn Øivind', 'Initials': 'BØ', 'LastName': 'Kvammen', 'Affiliation': 'Department of Dermatology, University Hospital of North Norway, Tromsö, Norway.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Swartling', 'Affiliation': 'Hidrosis Clinic, Stockholm, Sweden.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00537-9']
1743,32758684,Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.,"OBJECTIVE


To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars.
METHODS


One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots.
RESULTS


The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups.
CONCLUSIONS


After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).",2020,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","['150 4-8-year-old children', 'primary molars']","['glass ionomer cements (GICs', 'restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM', 'Atraumatic Restorative Treatment (ART', 'Fuji IX']","['overall survival rate of occlusal ART restorations', 'Restoration survival', '2-year survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3529286', 'cui_str': 'Maxxion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0977731,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Olegário', 'Affiliation': 'Department of Public and Child Dental Health, Dublin Dental University Hospital, University of Dublin, Trinity College, Dublin, Ireland; Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nathalia de Miranda', 'Initials': 'NM', 'LastName': 'Ladewig', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Clarissa Calil', 'Initials': 'CC', 'LastName': 'Bonifácio', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Carlos Pettorossi', 'Initials': 'JCP', 'LastName': 'Imparato', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103446']
1744,32758689,"SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.","BACKGROUND


The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial.
METHODS


In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance.
RESULTS


Novaferon inhibited viral replication (EC 50 =1.02ng/ml), and prevented viral infection (EC 50 =0.10ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p=0.0400, and 60.0% vs. 24.1%, p=0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group.
CONCLUSIONS


Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon.
TRIAL REGISTRATION NUMBER


Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).",2020,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","['COVID-19 patients with treatment of Novaferon', 'COVID-19 Patients with Novaferon Treatment']","['Lopinavir/Ritonavir', 'Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir', 'Novaferon', '6than Lopinavir/Ritonavir']","['viral infection', 'SARS-CoV-2 Clearance', 'Median time to viral clearance', 'viral replication', 'SARS-CoV-2 clearance rates', 'time to SARS-CoV-2 clearance', 'viral clearance rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",89.0,0.111733,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yaxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Internal Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Niu', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: jiangyongfang@csu.edu.cn.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China. Electronic address: 1286779459@qq.com.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: gongguozhong@csu.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.053']
1745,32768682,Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.,"Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and implementation of this approach. Thus, we will conduct a two-arm randomized trial in 128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing. The primary aim will compare weight loss between interventions arms across 6 months. Secondarily, we will compare weight loss (0-18 mos.), the proportion of participants who achieve clinically meaningful weight loss (≥5%) from 0 to 6 and 0 to18 months, and changes in quality of life from 0 to 6 and 0 to 18 months between interventions arms. We will also conduct cost, cost-effectiveness and contingent valuation comparisons and explore the influence of behavioral session attendance, compliance with the recommendations for diet and physical activity, self-monitoring of diet and physical activity, barriers to physical activity, sleep quality, and medications on weight change across 6 and 18 months. NCT REGISTRATION: NCT04046471.",2020,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","['adults with mobility related disabilities', 'adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an', '128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between', 'Adults with mobility related disabilities (MRDs']","['Weight management', 'enhanced Stop Light Diet (eSLD', 'interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing']","['quality of life', 'weight loss', 'physical activity, sleep quality, and medications on weight change', 'meaningful weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0419181', 'cui_str': 'Light diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",128.0,0.0374796,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@kumc.edu.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Smith', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: psmith18@kumc.edu.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: mmayo@kumc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rlee2@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106098']
1746,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2020,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
1747,32778913,"Acute mechanical, physiological and perceptual responses in older men to traditional-set or different cluster-set configuration resistance training protocols.","PURPOSE


The aims of this study were to compare mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses in older men to traditional-set or different cluster-set configuration resistance training protocols.
METHODS


In a randomized cross-over design, 20 healthy old men (aged 67.2 ± 2.1 years) completed four resistance training sessions using the back squat exercise loaded with optimal power loads. Training configurations were: traditional (TRA), three sets of six repetitions with 120-s rest between each set; Cluster-set 1 (CLU1), 24 single-repetition clusters with 10 s of rest after every cluster; Cluster-set 2 (CLU2), 12 double-repetition clusters with 20-s rest after every cluster; and Cluster-set 4 (CLU4), 6 quadruple-repetition clusters with 40-s rest after every cluster.
RESULTS


Cluster-set configurations resulted in greater power outputs compared to traditional-set configuration (range 2.6-9.2%, all p [Formula: see text] 0.07 for main effect and protocol [Formula: see text] set interactions). CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU, all p [Formula: see text] 0.006 for pairwise comparisons) and lower ratings of fatigue (range - 0.15 to - 4 AU, all p [Formula: see text] 0.012 for pairwise comparisons) compared to TRA and CLU4. Finally, an absolute preference for CLU2 was reported.
CONCLUSIONS


Findings presented here support the prescription of CLU2 as an optimal resistance training configuration for trained older men using the back squat.",2020,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","['trained older men using the back squat', '20 healthy old men (aged 67.2\u2009±\u20092.1\xa0years', 'older men to traditional-set or different cluster-set configuration resistance training protocols', 'older men']","['CLU1 and CLU2', 'resistance training sessions using the back squat exercise loaded with optimal power loads']","['heart rate', 'lower ratings of fatigue', 'mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses', 'Acute mechanical, physiological and perceptual responses']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.043265,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK. antonio.delloiacono@uws.ac.uk.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Martone', 'Affiliation': ""Universita' Degli Studi di Napoli (Dipartimento di Science Motorie e Benessere), Naples, Italy.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04453-y']
1748,32777692,Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.,"OBJECTIVE


To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.
METHODS


We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.
RESULTS


We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.
CONCLUSION


Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.",2020,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","['persons with opioid use disorder seeking treatment', 'persons with opioid use disorder (OUD', 'participants who reported HRQoL beyond baseline']","['naltrexone or buprenorphine-naloxone', 'opioid use disorder pharmacotherapy']",['health-related quality-of-life (HRQoL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",508.0,0.0789426,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA. Electronic address: alj4004@med.cornell.edu.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Ryan', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108221']
1749,32657505,Sebelipase alfa for lysosomal acid lipase deficiency: 5-year treatment experience from a phase 2 open-label extension study.,"BACKGROUND AND AIMS


Lysosomal acid lipase deficiency is characterized by hepatomegaly and dyslipidaemia, which can lead to cirrhosis and premature atherosclerosis. Sebelipase alfa is an approved recombinant human lysosomal acid lipase. In an open-label extension study of adults with lysosomal acid lipase deficiency (LAL-CL04), sebelipase alfa treatment for 1 year reduced serum transaminase levels and liver fat content and improved serum lipid levels.
METHODS


Final data from LAL-CL04 are reported herein for patients who received sebelipase alfa infusions (1.0 or 3.0 mg/kg every other week) for up to 5 years.
RESULTS


Of 8 patients enrolled, 7 received sebelipase alfa for 224-260 weeks; 1 was lost to follow-up. Median baseline levels of alanine aminotransferase and aspartate aminotransferase (81.5 and 50.0 U/L, respectively) were decreased through the end-of-study visit (54.0 and 34.0 U/L). Median low-density lipoprotein cholesterol decreased from 113 to 78 mg/dL, total cholesterol decreased from 171 to 132 mg/dL, and high-density lipoprotein cholesterol increased from 37 to 42 mg/dL. Most treatment-emergent adverse events were nonserious (99%), mild/moderate (98%) and unrelated to sebelipase alfa (87%); no patient discontinued as a result of treatment-emergent adverse events. One patient had 2 serious treatment-emergent adverse events (cholecystitis and cholelithiasis; assessed as unlikely related to sebelipase alfa). Two patients had 20 nonserious infusion-associated reactions in weeks 6-38; all were manageable. One patient tested positive for antidrug antibodies (single occurrence).
CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov record NCT01488097.",2020,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","['adults with lysosomal acid lipase deficiency (LAL-CL04', 'adults with lysosomal acid lipase deficiency', 'Of 8 patients enrolled']","['Sebelipase alfa', 'sebelipase alfa infusions']","['Median baseline levels of alanine aminotransferase and aspartate aminotransferase', 'tolerated and improved serum transaminase and lipid levels', 'total cholesterol', 'high-density lipoprotein cholesterol', 'serum transaminase levels and liver fat content and improved serum lipid levels', 'Median low-density lipoprotein cholesterol']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043208', 'cui_str': ""Wolman's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4050579', 'cui_str': 'sebelipase alfa'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",8.0,0.0400227,"CONCLUSIONS


Sebelipase alfa was well tolerated and improved serum transaminase and lipid levels for up to 5 years in adults with lysosomal acid lipase deficiency.
","[{'ForeName': 'Vĕra', 'Initials': 'V', 'LastName': 'Malinová', 'Affiliation': ""Department for Metabolic Diseases, Children's Clinic, General Faculty Hospital and First Faculty of Medicine of Charles University in Prague, Prague, Czech Republic.""}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Balwani', 'Affiliation': 'Department of Genetics and Genomic Sciences and Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Endocrinology and Metabolic Medicine, Salford Royal Foundation NHS Trust, Salford, UK.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Arnoux', 'Affiliation': 'Department of Inherited Metabolic Diseases, Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kane', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Chester B', 'Initials': 'CB', 'LastName': 'Whitley', 'Affiliation': 'Advanced Therapies Program, and Gene Therapy Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Marulkar', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Abel', 'Affiliation': 'Alexion Pharmaceuticals, Inc., Boston, MA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14603']
1750,32749938,Bevacizumab Plus mFOLFOX6 Versus mFOLFOX6 Alone as First-Line Treatment for  RAS  Mutant Unresectable Colorectal Liver-Limited Metastases: The BECOME Randomized Controlled Trial.,"PURPOSE


To assess the effects of bevacizumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) as first-line treatment of  RAS  mutant unresectable colorectal liver metastases.
METHODS


From October 2013 to December 2017, patients with  RAS  mutant unresectable liver-limited metastases from colorectal cancer were randomly assigned to receive mFOLFOX6 plus bevacizumab (arm A) or mFOLFOX6 alone (arm B). The resectability of liver metastases was determined by a local multidisciplinary team. The primary end point was the actual rate of patients converted to R0 resection for liver metastases. Secondary end points included tumor response, survival, and toxicity. The block randomization method was used.
RESULTS


The intention-to-treat population comprised 241 patients. A total of 121 patients were randomly assigned to arm A and 120 to arm B. The median follow-up time was 37.0 months for all patients. The R0 resection rates for liver metastases were 22.3% (27 of 121 patients) in arm A and 5.8% (7 of 120 patients) in arm B, with a significant difference ( P  < .01). Patients in arm A had significantly better objective response rates (54.5%  v  36.7%;  P  < .01), median progression-free survival (9.5  v  5.6 months;  P  < .01) and median overall survival (25.7  v  20.5 months;  P  = .03) compared with those in arm B. The addition of bevacizumab was associated with more frequent proteinuria (9.9%  v  3.3%;  P  = .04) and hypertension (8.3%  v  2.5%;  P  < .05).
CONCLUSION


For patients with initially unresectable  RAS  mutant colorectal liver metastases, bevacizumab combined with mFOLFOX6 increased the resectability of liver metastases and improved response rates and survival compared with mFOLFOX6 alone.",2020,"The R0 resection rates for liver metastases were 22.3% (27 of 121 patients) in arm A and 5.8% (7 of 120 patients) in arm B, with a significant difference ( P  < .01).","['From October 2013 to December 2017', 'RAS  Mutant Unresectable Colorectal Liver-Limited Metastases', 'patients with  RAS  mutant unresectable liver-limited metastases from colorectal cancer', 'RAS  mutant unresectable colorectal liver metastases', 'A total of 121 patients were randomly assigned to arm A and 120 to arm B']","['mFOLFOX6 plus bevacizumab (arm A) or mFOLFOX6 alone', 'bevacizumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6', 'Bevacizumab Plus mFOLFOX6 Versus mFOLFOX6 Alone', 'bevacizumab']","['frequent proteinuria', 'median progression-free survival', 'resectability of liver metastases', 'R0 resection rates for liver metastases', 'objective response rates', 'median overall survival', 'actual rate of patients converted to R0 resection for liver metastases', 'response rates and survival', 'hypertension', 'tumor response, survival, and toxicity']","[{'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",121.0,0.164236,"The R0 resection rates for liver metastases were 22.3% (27 of 121 patients) in arm A and 5.8% (7 of 120 patients) in arm B, with a significant difference ( P  < .01).","[{'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Ye', 'Affiliation': ""Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'He', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': ""Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ""Department of Oncology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of General Surgery, Zhongshan Hospital, Fudan University, and Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive, Shanghai, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00174']
1751,32750431,Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.,"BACKGROUND


Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss.
METHODS


Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support.
DISCUSSION


This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.",2020,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.",['Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity'],"['training in principles of cognitive behavioral therapy', 'standard weight management program alone or with their partner']","['Partner weight and caloric intake', 'participant weight loss at 24\u202fmonths, with caloric intake and moderate-intensity physical activity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0164121,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.","[{'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA; William S Middleton Memorial Veterans Hospital, 2500 Overlook Terrace (151), Madison, WI 53705, USA. Electronic address: voils@surgery.wisc.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shaw', 'Affiliation': 'Duke University School of Nursing, 307 Trent Dr., 1055 Clipp, Durham, NC 27710, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Adler', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, One Brigham Circle, 1620 Tremont Street Suite 2-016, Boston, MA 02120, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jeanes', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, 119 S. Main St., Union Trust Bldg., Suite 220, Seattle, WA 98104, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Sharp', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Cronin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Johnson', 'Affiliation': ""Boca Raton Regional Hospital, Christine E. Lynn Women's Health & Wellness Institute, 690 Meadows Road, Boca Raton, FL 33486, USA.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Elwert', 'Affiliation': 'University of Wisconsin-Madison Department of Sociology, 11800 Observatory Dr, Madison, WI 53706, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Pabich', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Medicine, 1685 Highland Ave Madison, WI 53705-2281, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Gavin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University School of Medicine, Department of Medicine, 501 Douglas St., Durham, NC 27705, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Box 90399, Durham, NC 27708, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106092']
1752,32750499,Improving episodic memory: Frontal-midline theta neurofeedback training increases source memory performance.,"Cognitive and neurofeedback training (NFT) studies have demonstrated that training-induced alterations of frontal-midline (FM) theta activity (4-8 Hz) transfer to cognitive control processes. Given that FM theta oscillations are assumed to provide top-down control for episodic memory retrieval, especially for source retrieval, that is, accurate recollection of contextual details of prior episodes, the present study investigated whether FM theta NFT transfers to memory control processes. It was assessed (1) whether FM theta NFT improves source retrieval and modulates its underlying EEG characteristics and (2) whether this transfer extends over two posttests. Over seven NFT sessions, the training group who trained individual FM theta activity showed greater FM theta increase than an active control group who trained randomly chosen frequency bands. The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases. Thus, training-induced enhancement of memory control processes seems to protect newly formed memories from proactive interference of previously learned information. EEG analyses revealed that during pretest both groups showed source memory specific theta activity at frontal and parietal sites. Surprisingly, training-induced improvements in source retrieval tended to be accompanied by less prestimulus FM theta activity, which was predicted by NFT theta change for the training but not the control group, suggesting a more efficient use of memory control processes after training. The present findings provide unique evidence for the enhancement of memory control processes by FM theta NFT.",2020,The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases.,[],"['FM theta NFT', 'Cognitive and neurofeedback training (NFT']","['FM theta increase', 'source retrieval', 'source memory specific theta activity']",[],"[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0178591,The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases.,"[{'ForeName': 'Kathrin C J', 'Initials': 'KCJ', 'LastName': 'Eschmann', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany; Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff, United Kingdom. Electronic address: eschmannk@cardiff.ac.uk.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Bader', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Mecklinger', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117219']
1753,32753113,[Efficacy of different doses and timing of tranexamic acid in major orthopedic surgeries: a randomized trial].,"BACKGROUND


Tranexamic acid was studied in four different dosage regimens and their efficacy was compared for perioperative blood loss reduction, blood transfusion requirements and deep vein thrombosis (DVT) complication.
METHODS


Two hundred patients undergoing major orthopedic procedures were divided into five groups containing 40 each: placebo, low dose (bolus 10mg.kg -1 ), low dose+maintenance (bolus 10mg.kg -1 +maintenance 1mg.kg -1 .hr -1 ), high dose (bolus 30mg.kg -1 ) and high dose+maintenance (bolus 30mg.kg -1 +maintenance 3mg.kg -1 .hr -1 ). Surgical blood loss was measured intraoperatively and drains collection in the first 24 hours postoperative period. Blood transfusion was done when hematocrit falls less than 25%. DVT screening was done in the postoperative period.
RESULTS


The intraoperative blood loss was 440±207.54mL in the placebo group, 412.5±208.21mL in the low dose group, 290±149.6ml in the low dose plus maintenance group, 332.5±162.33mL in the high dose group and 240.7±88.15mL in the high dose maintenance group (p <0.001). The reduction in postoperative blood loss in the drain for the first 24hours was 80±44.44mL in the placebo group, 89.88±44.87mL in the low dose group, 56.7±29.12mL in the low dose plus maintenance group, 77.9±35.74mL in the high dose group and 46.7±19.9mL in the high dose maintenance group (p <0.001). DVT was not encountered in any patient.
CONCLUSION


Tranexamic acid was most effective in reducing surgical blood loss and blood transfusion requirements in a low dose+maintenance group.",2020,"The reduction in postoperative blood loss in the drain for the first 24hours was 80±44.44mL in the placebo group, 89.88±44.87mL in the low dose group, 56.7±29.12mL in the low dose plus maintenance group, 77.9±35.74mL in the high dose group and 46.7±19.9mL in the high dose maintenance group (p <0.001).","['major orthopedic surgeries', 'Two hundred patients undergoing major orthopedic procedures']","['placebo', 'placebo, low dose (bolus 10mg.kg -1 ), low dose+maintenance (bolus 10mg.kg -1 ', 'tranexamic acid', 'Tranexamic acid']","['DVT', 'surgical blood loss and blood transfusion requirements', 'postoperative blood loss', 'perioperative blood loss reduction, blood transfusion requirements and deep vein thrombosis (DVT) complication', 'Surgical blood loss', 'Blood transfusion', 'intraoperative blood loss']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524852', 'cui_str': 'Orthopaedic procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0079027', 'cui_str': 'Intraoperative hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",200.0,0.255206,"The reduction in postoperative blood loss in the drain for the first 24hours was 80±44.44mL in the placebo group, 89.88±44.87mL in the low dose group, 56.7±29.12mL in the low dose plus maintenance group, 77.9±35.74mL in the high dose group and 46.7±19.9mL in the high dose maintenance group (p <0.001).","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Saravanan', 'Affiliation': 'SRM Medical College Hospital and Research Centre, Department of Anaesthesia, Tamilnadu, India.'}, {'ForeName': 'Rajagopalan', 'Initials': 'R', 'LastName': 'Venkatraman', 'Affiliation': 'SRM Medical College Hospital and Research Centre, Department of Anaesthesia, Tamilnadu, India. Electronic address: drvenkat94@gmail.com.'}, {'ForeName': 'Krishnamoorthy', 'Initials': 'K', 'LastName': 'Karthik', 'Affiliation': 'SRM Medical College Hospital and Research Centre, Department of Anaesthesia, Tamilnadu, India.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Pushparani', 'Affiliation': 'SRM Medical College Hospital and Research Centre, Department of Anaesthesia, Tamilnadu, India.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.013']
1754,31611625,The relative importance of factors predicting outcome for myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial.,"Disease factors such as tumor burden and molecular risk affect myeloma patient outcomes as well as patient factors that impact the capacity to deliver treatment. How the relative importance of these factors changes with patient age has not previously been investigated comprehensively. We analyzed data from 3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI. Even with novel therapeutic approaches progression-free survival (PFS) and overall survival (OS) are affected by age with a stepwise reduction in PFS and OS with each decade increase. Renal function deteriorated with increasing age whilst the frequency of t(4;14) and del(17p) decreased and gain(1q) increased. The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group. Molecular events have a larger effect on outcome in younger patients with their relative contribution diminishing in the elderly. Performance status is important for patient outcome at all ages suggesting that physical frailty may be a more important predictor of outcome than age itself. Significant differences in the factors driving patient outcomes at different ages are important to consider as we design disease segmentation strategies to deliver personalized treatment approaches.",2020,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","['myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial', 'younger patients with their relative contribution diminishing in the elderly', '3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI']",[],"['relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0547204,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK. charlotte.pawlyn@icr.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vallari', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Section of Experimental Haematology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}]",Leukemia,['10.1038/s41375-019-0595-5']
1755,32756520,Combination Preemptive Peripheral Nerve Block in Limb Surgery. A Prospective Study.,"Background and objectives : Patients often suffer from moderate to severe pain during the early recovery period in orthopedic surgery. We investigated the impact of a single-shot preoperative peripheral nerve block (PNB) on post-anesthesia recovery parameters and interleukin (IL)-6 level during limb surgery.  Materials and Methods:  A prospective randomized controlled study was conducted, and patients scheduled for limb surgery were recruited. Sixty patients were randomly assigned to either the PNB group or control group, who received morphine as a primary analgesic. The peak verbal numeric rating scale (NRS) score in the post-anesthesia care unit (PACU) was evaluated as a primary outcome. We also recorded rescue analgesics requirement and wake-up time from anesthesia in the PACU. In addition, the change of plasma IL-6 level after incision was measured.  Results : Fifty-two patients completed the study, 27 and 25 cases in the PNB and control group, respectively. Preemptive PNB significantly reduced peak NRS score in the PACU compared to control group. Lower rescue analgesics requirement and rapid wake-up from anesthesia were also noted in PNB group. The IL-6 concentration increased less in the PNB group at 2 h after incision.  Conclusions : Preemptive PNB attenuates IL-6 expression 2 h after incision and improves pain management in the PACU. PNB was considered as an essential part of pain management in limb surgery.",2020,The IL-6 concentration increased less in the PNB group at 2 h after incision.  ,"['Fifty-two patients completed the study, 27 and 25 cases in the PNB and control group, respectively', 'Limb Surgery', 'patients scheduled for limb surgery were recruited', 'Sixty patients', ' and objectives : Patients often suffer from moderate to severe pain during the early recovery period in orthopedic surgery']","['PNB', 'Preemptive PNB', 'single-shot preoperative peripheral nerve block (PNB', 'morphine']","['peak NRS score', 'plasma IL-6 level', 'pain management', 'Lower rescue analgesics requirement and rapid wake-up from anesthesia', 'IL-6 concentration', 'peak verbal numeric rating scale (NRS) score']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",60.0,0.0627649,The IL-6 concentration increased less in the PNB group at 2 h after incision.  ,"[{'ForeName': 'I-Cheng', 'Initials': 'IC', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Shu-Hung', 'Initials': 'SH', 'LastName': 'Huang', 'Affiliation': 'Department of Surgery, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'David Vi', 'Initials': 'DV', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Municipal Siaogang Hospital, Kaohsiung 812, Taiwan.'}, {'ForeName': 'Chun Dan', 'Initials': 'CD', 'LastName': 'Hsu', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Municipal Siaogang Hospital, Kaohsiung 812, Taiwan.'}, {'ForeName': 'Sheng Hua', 'Initials': 'SH', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, College of Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56080388']
1756,32758455,"Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study.","BACKGROUND


Debio 1143 is an orally available antagonist of inhibitor of apoptosis proteins with the potential to enhance the antitumour activity of cisplatin and radiotherapy. The radiosensitising effect of Debio 1143 is mediated through caspase activation and TNF, IFNγ, CD8 T cell-dependent pathways. We aimed to investigate the efficacy and safety of Debio 1143 in combination with standard chemoradiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.
METHODS


This double-blind, multicentre, randomised, phase 2 study by the French Head and Neck Radiotherapy Oncology Group (GORTEC) was run at 19 hospitals in France and Switzerland. Eligible patients were aged 18-75 years with locoregionally advanced, squamous cell carcinoma of the head and neck (characterised as non-metastatic, measurable stage III, IVa, or IVb [limited to T ≥2, N0-3, and M0] disease), Eastern Cooperative Oncology Group performance status of 0 or 1, a history of heavy tobacco smoking (>10 pack-years) with no previous or current treatment for invasive head and neck cancer, and no previous treatment with inhibitor of apoptosis protein antagonists. Patients were randomly assigned (1:1) to receive oral Debio 1143 (200 mg per day on days 1-14 of 21-day cycles, for three cycles) or oral placebo (20 mg/mL, administered at the same dosing schedule) using a stochastic minimisation technique according to node involvement and primary tumour site, and HPV-16 status in patients with an oropharyngeal primary tumour site. All patients received standard high-dose cisplatin chemoradiotherapy. The primary endpoint was the proportion of patients with locoregional control 18 months after chemoradiotherapy, analysed in the intention-to-treat population (primary analysis), and repeated in the per-protocol population. Responses were assessed according to Response Evaluation Criteria in Solid Tumors (version 1.1). This trial is registered with ClinicalTrials.gov, NCT02022098, and is still active but not recruiting.
FINDINGS


Between Jan 25, 2016, and April 24, 2017, 48 patients were randomly assigned to the Debio 1143 group and 48 to the placebo group (one patient in the placebo group did not receive the study drug and was not included in the safety analysis). Median duration of follow-up was 25·0 months (IQR 19·6-29·4) in the Debio 1143 group and 24·2 months (6·6-26·8) in the placebo group. Locoregional control 18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026). Grade 3 or worse adverse events were reported in 41 (85%) of 48 patients in the Debio 1143 group and in 41 (87%) of 47 patients in the placebo group. The most common grade 3-4 adverse events were dysphagia (in 24 [50%] patients in the Debio 1143 group vs ten [21%] in the placebo group), mucositis (in 15 [31%] vs ten [21%]), and anaemia (in 17 [35%] vs 11 [23%]). Serious treatment-emergent adverse events were recorded in 30 (63%) of 48 patients in the Debio 1143 group and 28 (60%) of 47 in the placebo group. In the placebo group, two (4%) deaths were due to adverse events (one multiple organ failure and one asphyxia; neither was considered to be related to treatment). No deaths due to adverse events occurred in the Debio 1143 group.
INTERPRETATION


To our knowledge, this is the first treatment regimen to achieve superior efficacy in this disease setting against a high-dose cisplatin chemoradiotherapy comparator in a randomised trial. These findings suggest that inhibition of inhibitor of apoptosis proteins is a novel and promising approach in this poor prognostic population and warrant confirmation in a phase 3 study with the aim of expanding the therapeutic options for these patients.
FUNDING


Debiopharm.",2020,"18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026).","['patients with an oropharyngeal primary tumour site', 'French Head and Neck Radiotherapy Oncology Group (GORTEC) was run at 19 hospitals in France and Switzerland', 'patients with high-risk locally advanced squamous cell carcinoma of the head and neck', 'high-risk locoregionally advanced squamous cell carcinoma of the head and neck', '48 patients were randomly assigned to the Debio 1143 group and 48 to the', 'Between Jan 25, 2016, and April 24, 2017', 'Eligible patients were aged 18-75 years with locoregionally advanced, squamous cell carcinoma of the head and neck (characterised as non-metastatic, measurable stage III, IVa, or IVb [limited to T ≥2, N0-3, and M0] disease), Eastern Cooperative Oncology Group performance status of 0 or 1, a history of heavy tobacco smoking (>10 pack-years) with no previous or current treatment for invasive head and neck cancer, and no previous treatment with inhibitor of apoptosis protein antagonists']","['standard high-dose cisplatin chemoradiotherapy', 'Debio 1143 in combination with standard chemoradiotherapy', 'cisplatin chemoradiotherapy comparator', 'oral placebo', 'oral Debio', 'Debio 1143 and high-dose cisplatin chemoradiotherapy', 'cisplatin and radiotherapy', 'placebo']","['proportion of patients with locoregional control', 'Median duration', 'dysphagia', 'caspase activation and TNF, IFNγ, CD8 T cell-dependent pathways', 'mucositis', 'efficacy and safety', 'anaemia', 'Serious treatment-emergent adverse events', 'adverse events', 'Locoregional control', 'Grade 3 or worse adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0475447', 'cui_str': 'Primary tumor site'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2983774', 'cui_str': 'AT 406'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0893445', 'cui_str': 'Inhibitor-Of-Apoptosis Protein'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C2983774', 'cui_str': 'AT 406'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",48.0,0.373852,"18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026).","[{'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, Nord Franche-Comté de Montbéliard and CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Le Tourneau', 'Affiliation': 'Department of Drug Development and Innovation, Institut Curie, Paris, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Oncologie-Radiothérapie, Institut Inter-RégionaL de Cancérologie, Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Bretagne Sud, Hôpital du Scorff Radiothérapie, Lorient, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': ""L'Institut de Cancérologie de Lorraine Alexis Vautrin, Oncologie Médicale, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU Amiens Picardie, Oncologie-Radiothérapie, Amiens, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Radiothérapie, Avignon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': ""Institut du Cancer de Montpellier, Val d'Aurelle, Oncologie-Radiothérapie, Montpellier, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Radiothérapie, Le Havre, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Radiothérapie, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Ramee', 'Affiliation': 'CHD Vendée, Radiothérapie, La Roche Sur Yon, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': ""Institut Claudius Regaud, Oncopole, Unité de Recherche Clinique de l'Institut Claudius Regaud, Toulouse, France.""}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Clatot', 'Affiliation': ""Centre Henri Becquerel, Service Oncologie Médicale rue d'Amiens, Rouen, France.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Institut de Cancérologie de l'Ouest René Gauducheau, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Villa', 'Affiliation': 'CHU Grenoble, Radiothérapie, Pôle de Cancérologie, Grenoble, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magne', 'Affiliation': 'Institut de Cancérologie Lucien Neuwirth, Radiothérapie, Saint-Priest en Jarez, France.'}, {'ForeName': 'Olgun', 'Initials': 'O', 'LastName': 'Elicin', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elisabeta', 'Initials': 'E', 'LastName': 'Gherga', 'Affiliation': 'Department of Radiation Oncology, Nord Franche-Comté de Montbéliard and CHRU de Besançon, Besançon, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Cedrick', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Oncologie-Radiothérapie, Institut Inter-RégionaL de Cancérologie, Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bera', 'Affiliation': 'Centre Hospitalier de Bretagne Sud, Hôpital du Scorff Radiothérapie, Lorient, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Calugaru', 'Affiliation': 'Department of Drug Development and Innovation, Institut Curie, Paris, France.'}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': ""L'Institut de Cancérologie de Lorraine Alexis Vautrin, Oncologie Médicale, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': 'CHU Amiens Picardie, Oncologie-Radiothérapie, Amiens, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Zubel', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Zanna', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Brienza', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Crompton', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Rouits', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Gollmer', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Szyldergemajn', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV, Service de Radio-oncologie, Bâtiment Hospitalier, Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30327-2']
1757,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
1758,32758677,Inspiratory neural drive and dyspnea in interstitial lung disease: Effect of inhaled fentanyl.,"BACKGROUND


Exertional dyspnea in interstitial lung disease (ILD) remains difficult to manage despite advances in disease-targeted therapies. Pulmonary opioid receptors present a potential therapeutic target for nebulized fentanyl to provide dyspnea relief.
METHODS


ILD patients were characterized with reference to healthy volunteers. A randomized, double-blind, placebo-controlled crossover comparison of 100 mcg nebulized fentanyl vs placebo on dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise was performed in 21 ILD patients.
RESULTS


Dyspnea intensity in ILD increased in association with an increase in IND (diaphragm activation) from a high resting value of 16.66 ± 6.52 %-60.04 ± 12.52 % of maximum (r = 0.798, p < 0.001). At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
CONCLUSION


IND rose sharply during constant work rate exercise in association with dyspnea intensity in mild to moderate ILD but was not different after nebulized fentanyl compared with placebo.",2020,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","['ILD patients were characterized with reference to healthy volunteers', 'interstitial lung disease', '21 ILD patients']","['inhaled fentanyl', '100 mcg nebulized fentanyl vs placebo', 'nebulized fentanyl', 'fentanyl vs placebo', 'placebo']","['IND responses', 'IND (diaphragm activation', 'dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise', 'dyspnea intensity ratings', 'Inspiratory neural drive and dyspnea']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",21.0,0.334941,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada; Clinician Investigator Program, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Ibrahim-Masthan', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Moran-Mendoza', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Neder', 'Initials': 'N', 'LastName': 'Ja', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada. Electronic address: odonnell@queensu.ca.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103511']
1759,32767679,"A phase I, randomized, double-blind study to assess the safety, tolerability and efficacy of the topical RORC2 inverse agonist PF-06763809 in participants with mild-to-moderate plaque psoriasis.","BACKGROUND


Transcription factor retinoic acid-related orphan receptor 2 (RORC2/RORγT) mediates interleukin (IL)-17A and IL-17F expression. IL-17A plays a central role in the pathogenesis of several inflammatory disorders, including psoriasis. The RORC2 inhibitor PF-06763809 has been hypothesized to inhibit IL-17A production in T-helper 17 (Th17) cells, thereby reducing psoriasis symptoms.
AIM


To assess the safety, tolerability and effect on skin infiltrate thickness of PF-06763809 in participants with mild/moderate chronic plaque psoriasis.
METHODS


This was a randomized, double-blind, first-in-human study (trial registration: ClinicalTrials.gov NCT03469336). Participants received each of the following six treatments once daily for 18 days: three topical doses (2.3%, 0.8%, 0.23%) of PF-06763809, a vehicle and two active comparators (betamethasone and calcipotriol). Primary endpoints included change from baseline in psoriatic skin infiltrate thickness [echo-poor band (EPB) on ultrasonography] at Day 19, and safety. Change in psoriasis-associated gene expression (Day 19), evaluated by real-time reverse transcription PCR of skin biopsies, was an exploratory endpoint.
RESULTS


In total, 17 participants completed the study. Change from baseline in the EPB on Day 19 for all three doses of PF-06763809 was not significantly different from that of vehicle (P > 0.05). A significant reduction in EPB from baseline was observed with betamethasone on Day 19 relative to all other treatments (P < 0.0001). Treatment-related adverse events were mild/moderate. There were no significant differences in gene expression on Day 19 between vehicle and PF-06763809-treated skin lesions.
CONCLUSION


Using a psoriasis plaque test design, PF-06763809 was found to be well tolerated with an acceptable safety profile in participants with psoriasis, but without reduction in skin infiltrate thickness or disease biomarkers.",2020,"There were no significant differences in gene expression on Day 19 between vehicle and PF-06763809-treated skin lesions.
","['participants with mild-to-moderate plaque psoriasis', 'participants with mild/moderate chronic plaque psoriasis', 'participants with psoriasis', 'Seventeen participants completed the study']","['betamethasone', 'IL-17A', 'topical RORC2 inverse agonist PF-06763809', 'RORC2 inhibitor', 'PF-06763809, vehicle, and two active comparators (betamethasone and calcipotriol']","['psoriatic skin infiltrate thickness (echo-poor band [EPB] by ultrasound) at Day 19 and safety', 'skin infiltrate thickness or disease biomarkers', 'gene expression', 'EPB', 'safety, tolerability', 'safety, tolerability, and efficacy']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}]","[{'cui': 'C0241076', 'cui_str': 'Skin infiltration'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",17.0,0.371838,"There were no significant differences in gene expression on Day 19 between vehicle and PF-06763809-treated skin lesions.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berstein', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Berger', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kieras', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Early Clinical Development, Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samuel', 'Affiliation': 'Formulation and Process Design, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yeoh', 'Affiliation': 'Formulation and Process Design, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dowty', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Beaumont', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wigger-Alberti', 'Affiliation': 'Bioskin GmbH, Hamburg, Germany.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'von Mackensen', 'Affiliation': 'Bioskin GmbH, Hamburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Kroencke', 'Affiliation': 'Bioskin GmbH, Hamburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hamscho', 'Affiliation': 'Rothhaar Studien GmbH, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Garcet', 'Affiliation': 'Rockefeller University, New York, NY, USA.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Rockefeller University, New York, NY, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Oemar', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc., Cambridge, MA, USA.'}]",Clinical and experimental dermatology,['10.1111/ced.14412']
1760,32762995,"Mapping From Visual Acuity to EQ-5D, EQ-5D With Vision Bolt-On, and VFQ-UI in Patients With Macular Edema in the LEAVO Trial.","OBJECTIVES


Mappings to convert clinical measures to preference-based measures of health such as the EQ-5D-3L are sometimes required in cost-utility analyses. We developed mappings to convert best-corrected visual acuity (BCVA) to the EQ-5D-3L, the EQ-5D-3L with a vision bolt-on (EQ-5D V), and the Visual Functioning Questionnaire-Utility Index (VFQ-UI) in patients with macular edema caused by central retinal vein occlusion.
METHODS


We used data from Lucentis, Eylea, Avastin in vein occlusion (LEAVO), which is a phase-3 randomized controlled trial comparing ranibizumab, aflibercept, and bevacizumab in 463 patients with observations at 6 time points. We estimated adjusted limited dependent variable mixture models consisting of 1 to 4 distributions (components) using BCVA in each eye, age, and sex to predict utility within the components and BCVA as a determinant of component membership. We compared model fit using mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions.
RESULTS


Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI. The best-fitting models for the EQ-5D and EQ-5D V had 2 components (with means of approximately 0.44 and 0.85), and the best-fitting model for VFQ-UI had 3 components (with means of approximately 0.95, 0.74, and 0.90).
CONCLUSIONS


Models with multiple components better predict utility than those with single components. This article provides a valuable addition to the literature, in which previous mappings in visual acuity have been limited to linear regressions, resulting in unfounded assumptions about the distribution of the dependent variable.",2020,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","['patients with macular edema caused by central retinal vein occlusion', '463 patients with observations at 6 time points', 'Patients With Macular Edema in the LEAVO Trial']","['ranibizumab, aflibercept, and bevacizumab', 'Lucentis, Eylea, Avastin in vein occlusion (LEAVO']","['mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions', 'Mean utility scores', 'Visual Functioning Questionnaire-Utility Index (VFQ-UI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",463.0,0.141225,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","[{'ForeName': 'Becky M', 'Initials': 'BM', 'LastName': 'Pennington', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK. Electronic address: b.pennington@sheffield.ac.uk.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Hernández-Alava', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hykin', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flight', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brazier', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.03.008']
1761,32762997,Mimicking Real-Life Decision Making in Health: Allowing Respondents Time to Think in a Discrete Choice Experiment.,"OBJECTIVE


To empirically test the impact of allowing respondents time to think (TTT) about their choice options on the outcomes of a discrete choice experiments (DCE).
METHODS


In total, 613 participants of the Swedish CArdioPulmonary bioImage Study (SCAPIS) completed a DCE questionnaire that measured their preferences for receiving secondary findings of a genetic test. A Bayesian D-efficient design with 60 choice tasks divided over 4 questionnaires was used. Each choice task contained 2 scenarios with 4 attributes: type of disease, disease penetrance probability, preventive opportunities, and effectiveness of prevention. Respondents were randomly allocated to the TTT or no TTT (NTTT) sample. Latent class models (LCMs) were estimated to determine attribute-level values and their relative importance. In addition, choice certainty, attribute-level interpretation, choice consistency, and potential uptake rates were compared between samples.
RESULTS


In the TTT sample, 92% of the respondents (245 of 267) indicated they used the TTT period to (1) read the information they received (72%) and (2) discuss with their family (24%). In both samples, respondents were very certain about their choices. A 3-class LCM was fitted for both samples. Preference reversals were found for 3 of the 4 attributes in one class in the NTTT sample (34% class-membership probability). Relative importance scores of the attributes differed between the 2 samples, and significant scale effects indicating higher choice consistency in TTT sample were found.
CONCLUSIONS


Offering respondents TTT influences decision making and preferences. Developers of future DCEs regarding complex health-related decisions are advised to consider this approach to enhance the validity of the elicited preferences.",2020,"Relative importance scores of the attributes differed between the 2 samples, and significant scale effects indicating higher choice consistency in TTT sample were found.
","['613 participants of the Swedish CArdioPulmonary bioImage Study (SCAPIS) completed a', 'Health']","['TTT or no TTT', 'DCE questionnaire']",['potential uptake rates'],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],613.0,0.0487338,"Relative importance scores of the attributes differed between the 2 samples, and significant scale effects indicating higher choice consistency in TTT sample were found.
","[{'ForeName': 'Jorien', 'Initials': 'J', 'LastName': 'Veldwijk', 'Affiliation': 'Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands. Electronic address: veldwijk@eshpm.eur.nl.'}, {'ForeName': 'Jennifer Viberg', 'Initials': 'JV', 'LastName': 'Johansson', 'Affiliation': 'Centre for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Donkers', 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Rotterdam, The Netherlands; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther W', 'Initials': 'EW', 'LastName': 'de Bekker-Grob', 'Affiliation': 'Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.02.014']
1762,32770431,ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field?,"PURPOSE OF REVIEW


Critical appraisal of the available evidence on the self-expanding ACURATE neo transcatheter heart valve (THV) for the treatment of aortic valve disease.
RECENT FINDINGS


In an investigator-initiated, multicenter, randomized non-inferiority trial with broad inclusion criteria, ACURATE neo failed to meet non-inferiority compared with SAPIEN 3 with regard to a primary composite safety and efficacy endpoint at 30 days. The difference was driven by higher rates of moderate or severe paravalvular regurgitation and higher rates of acute kidney injury. In turn, registry data suggest that the safety and efficacy profile of the ACURATE neo is comparable to that of other commercially available devices. Randomized evidence indicated favorable hemodynamic results with large effective orifice areas and low residual gradients. The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV. The supra-annular design with low residual gradients may be advantageous in patients with small anatomy and mild degree of calcification.",2020,The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV.,['patients with small anatomy and mild degree of calcification'],[],['residual aortic regurgitation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",[],"[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}]",,0.0784333,The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV.,"[{'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Okuno', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Lanz', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pilgrim', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, CH-3010, Bern, Switzerland. thomas.pilgrim@insel.ch.'}]",Current cardiology reports,['10.1007/s11886-020-01364-4']
1763,32772491,East Asian diet-mimicking diet plan based on the Mediterranean diet and the Dietary Approaches to Stop Hypertension diet in adults with type 2 diabetes: A randomized controlled trial.,"AIMS/INTRODUCTION


Using an investigational diet plan based on the Mediterranean diet and the Dietary Approaches to Stop Hypertension diet comprised of substitute ingredients that mimic the average East Asian diet, this study assessed the glycemic benefits in comparison with a food exchange system-based diet in established type 2 diabetes patients.
MATERIALS AND METHODS


This was a 12-week, open-label randomized clinical trial carried out among 60 Korean adults with type 2 diabetes having a median body mass index of 23.5 kg/m 2  . Glycemic benefits in the investigational diet (group A) were compared with those obtained with a food exchange system-based diet, either in the form of ready meals provided to participants (group B) or not (group C). The primary end-point was changes in glycated hemoglobin from baseline to week 12.
RESULTS


Changes in glycated hemoglobin (%) from baseline to week 12 were -0.97 ± 0.97 in group A (vs group B, P = 0.085 in the full analysis set, and P = 0.028 in the per-protocol set; vs group C, P = 0.030 in the full analysis set and P = 0.020 in the per-protocol set), -0.51 ± 0.65 in group B (vs group C, P > 0.05 in the full analysis set and the per-protocol set), and -0.36 ± 0.74 in group C. Decreases from baseline in body mass index, waist circumference and blood pressure were greater in group A than in group C.
CONCLUSION


With the provision of ready meals, the glycemic benefits of the investigational diet plan were demonstrable over a self-prepared food exchange system-based diet in Korean adults with established type 2 diabetes.",2020,"RESULTS


Changes in HbA1c (%) from baseline to week 12 were -0.97 ± 0.97 in group A (vs. group B, P = 0.085 in the full analysis set [FAS] and P = 0.028 in the per-protocol set [PPS]; vs. group C, P = 0.030 in FAS and P = 0.020 in PPS), -0.51 ± 0.65 in group B (vs. group C, P > 0.05 in FAS and PPS), and -0.36 ± 0.74 in group C. Decreases from baseline in body mass index, waist circumference, and blood pressure were greater in group A than in group C.
CONCLUSION


With provision of ready meals, the glycemic benefits of the investigational diet plan were demonstrable over a self-prepared FES-based diet in Korean adults with established type 2 diabetes.","['Adults with Type 2 Diabetes', 'Korean adults with established type 2 diabetes', '60 Korean adults with type 2 diabetes having a median body mass index of 23.5 kg/m 2  ']","['food exchange system (FES)-based diet', 'Mediterranean Diet and the DASH Diet']","['body mass index, waist circumference, and blood pressure', 'Glycemic benefits', 'changes in HbA1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",60.0,0.0399272,"RESULTS


Changes in HbA1c (%) from baseline to week 12 were -0.97 ± 0.97 in group A (vs. group B, P = 0.085 in the full analysis set [FAS] and P = 0.028 in the per-protocol set [PPS]; vs. group C, P = 0.030 in FAS and P = 0.020 in PPS), -0.51 ± 0.65 in group B (vs. group C, P > 0.05 in FAS and PPS), and -0.36 ± 0.74 in group C. Decreases from baseline in body mass index, waist circumference, and blood pressure were greater in group A than in group C.
CONCLUSION


With provision of ready meals, the glycemic benefits of the investigational diet plan were demonstrable over a self-prepared FES-based diet in Korean adults with established type 2 diabetes.","[{'ForeName': 'Sang-Man', 'Initials': 'SM', 'LastName': 'Jin', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University College of Medicine, Myongji Hospital, Goyang, Korea.'}, {'ForeName': 'Jiyun', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyu Yeon', 'Initials': 'KY', 'LastName': 'Hur', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Moon-Kyu', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Soonchunhyang University School of Medicine, Gumi, Korea.'}]",Journal of diabetes investigation,['10.1111/jdi.13384']
1764,32789505,Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials.,"Importance


A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.
Objective


To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.
Interventions


In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant-only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
Design, Setting, and Participants


Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.
Main Outcomes and Measures


The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Results


Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.
Conclusions and Relevance


In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration


Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.",2020,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","['China', '96 participants', '224 adults', 'Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years', '320 patients who were randomized (mean age, 42.8 years; 200 women [62.5']","['aluminum hydroxide (alum) adjuvant-only group', 'investigational inactivated whole-virus COVID-19 vaccine', 'Inactivated Vaccine Against SARS-CoV-2', 'placebo']","['serious adverse reactions', 'antibody responses', 'geometric mean titers of neutralizing antibodies', 'Safety and Immunogenicity Outcomes', 'safety and immunogenicity', 'plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', '7-day adverse reactions', 'neutralizing antibody response']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",224.0,0.329137,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Dongyang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Yunkai', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Wangyang', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Zhengli', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Lianghao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Shihe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wanshen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}]",JAMA,['10.1001/jama.2020.15543']
1765,32784930,"Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin: A Randomized, Dose Escalation Study in Healthy Adults.","Tetrodotoxin (TTX) is a highly specific voltage-gated sodium channel (VGSC) blocker in clinical evaluation as a peripheral-acting analgesic for chronic pain. This study presents the first published results of the safety including cardiac liability of TTX at therapeutic-relevant concentrations in twenty-five healthy adults. Randomized, double-blind, placebo-, and positive- (moxifloxacin) controlled study evaluated single ascending doses of 15 µg, 30 µg, and 45 µg TTX over 3 periods with a 7-day washout between each period. Subcutaneous injections of TTX were readily absorbed, reaching maximum plasma concentration (C max ) within 1.5 h. Both extent of exposure (AUC) and C max  increased in proportion to dose. No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study. Safety assessments showed no clinically relevant changes with values similar between all groups and no subject withdrawing due to adverse events. Paresthesia, oral-paresthesia, headache, dizziness, nausea, and myalgia were the most common TEAEs (overall occurrence ≥5%) in the TTX treatment groups. TTX doses investigated in this study are safe, well-tolerated, and lack proarrhythmic proclivity.",2020,"No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study.","['Healthy Adults', 'twenty-five healthy adults']","['sodium channel (VGSC) blocker', 'placebo-, and positive- (moxifloxacin', 'Tetrodotoxin (TTX', 'TTX']","['Paresthesia, oral-paresthesia, headache, dizziness, nausea, and myalgia', 'QT prolongation', 'Safety, Tolerability, Pharmacokinetics, and Concentration-QTc Analysis of Tetrodotoxin']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0037492', 'cui_str': 'Sodium Channel'}, {'cui': 'C3494197', 'cui_str': 'Sodium Channels, Voltage-Gated'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0039705', 'cui_str': 'Tetrodotoxin'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0521591', 'cui_str': 'Oral paresthesia'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039705', 'cui_str': 'Tetrodotoxin'}]",25.0,0.197221,"No QT prolongation was identified by concentration-QTc analysis and the upper bounds of the two-sided 90% confidence interval of predicted maximum baseline and placebo corrected QTcF (ΔΔQTcF) value did not exceed 10 ms for all tetrodotoxin doses, thereby meeting the criteria of a negative QT study.","[{'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Kavoosi', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Terry E', 'Initials': 'TE', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion Inc., Tempe, AZ 85283, USA.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Kavoosi', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chai', 'Affiliation': 'Celerion Inc., Lincoln, NE 68502, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': 'Celerion Inc., Montreal, QC H4M-2P1, Canada.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Korz', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Gallen', 'Affiliation': 'WEX Pharmaceuticals Inc., Vancouver, BC V6E-4A6, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Lester', 'Affiliation': 'Celerion Inc., Tempe, AZ 85283, USA.'}]",Toxins,['10.3390/toxins12080511']
1766,32785881,Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA ≥ 3: Post-Hoc Analysis From Three Randomized Controlled Trials.,"INTRODUCTION


Psoriasis is a chronic, inflammatory disease, which ranges in severity from mild to severe. Although topical therapies are frequently used to treat mild disease, they are not routinely used to treat patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥ 5% BSA). Based on well-controlled trials in adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg/g + betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous foam has been approved (Enstilar®, LEO Pharma) in the USA and EU for the treatment of psoriasis vulgaris for up to 4 weeks in adults. In this post-hoc subgroup analysis, we used pooled data from phase II/III trials to investigate the efficacy and safety of Cal/BD cutaneous foam in patients with moderate-to-severe psoriasis.
METHODS


Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA) ≥ 3. Endpoints included: treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety.
RESULTS


A total of 340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam. Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam. Sixty-six adverse events (AEs) occurred in 47 (18.5%) patients receiving Cal/BD foam and 11 AEs occurred in 11 (12.8%) patients receiving vehicle foam. Three severe AEs and 15 non-serious treatment-related AEs occurred in patients receiving Cal/BD foam.
CONCLUSION


The results from three clinical trials analyzed together show that topical Cal/BD foam is well tolerated and efficacious for treating patients with moderate-to-severe disease. Data support Cal/BD foam as a potential topical therapy for moderate-to-severe psoriasis.
TRIAL REGISTRATIONS


ClinicalTrials.gov registration numbers: NCT01866163, NCT02132936, NCT01536886.",2020,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[""Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA)\u2009≥\u20093"", '340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam', 'adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg', 'patients with moderate-to-severe psoriasis', 'Psoriasis in Patients With BSA 5-15% and PGA\u2009≥\u20093', 'patients with moderate-to-severe disease', 'patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥\u20095% BSA']","['g + betamethasone dipropionate 0.5', 'Calcipotriol/Betamethasone Dipropionate Cutaneous Foam']","[""treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety"", 'tolerated and efficacious']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3653162', 'cui_str': 'calcipotriol, combinations'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C1160727', 'cui_str': 'Cutaneous foam'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",340.0,0.163511,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Iversen', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark. lars.iversen@clin.au.dk.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Kurvits', 'Affiliation': 'Biostatistics Department, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Anja Marieke', 'Initials': 'AM', 'LastName': 'Snel-Prentø', 'Affiliation': 'Global Medical Affairs, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White Health, Dallas, TX, USA.'}]",Dermatology and therapy,['10.1007/s13555-020-00419-2']
1767,32785972,Nitric oxide is fundamental to neurovascular coupling in humans.,"KEY POINTS


Preclinical models have demonstrated that nitric oxide is a key component of neurovascular coupling; this has yet to be translated to humans. We conducted two separate protocols utilizing intravenous infusion of a nitric oxide synthase inhibitor and isovolumic haemodilution to assess the influence of nitric oxide on neurovascular coupling in humans. Isovolumic haemodilution did not alter neurovascular coupling. Intravenous infusion of a nitric oxide synthase inhibitor reduced the neurovascular coupling response by ∼30%, indicating that nitric oxide is integral to neurovascular coupling in humans.
ABSTRACT


Nitric oxide is a vital neurovascular signalling molecule in preclinical models, yet the mechanisms underlying neurovascular coupling (NVC) in humans have yet to be elucidated. To investigate the contribution of nitric oxide to NVC in humans, we utilized a visual stimulus paradigm to elicit an NVC response in the posterior cerebral circulation. Two distinct mechanistic interventions were conducted on young healthy males: (1) NVC was assessed during intravenous infusion of saline (placebo) and the non-selective competitive nitric oxide synthase inhibitor N G  -monomethyl-l-arginine (l-NMMA, 5 mg kg -1  bolus & subsequent 50 μg kg -1   min -1  maintenance dose; n = 10). The order of infusion was randomized, counterbalanced and single blinded. A subset of participants in this study (n = 4) underwent a separate intervention with phenylephrine infusion to independently consider the influence of blood pressure changes on NVC (0.1-0.6 μg kg -1   min -1  constant infusion). (2) NVC was assessed prior to and following isovolumic haemodilution, whereby 20% of whole blood was removed and replaced with 5% human serum albumin to reduce haemoglobin concentration (n = 8). For both protocols, arterial and internal jugular venous blood samples were collected at rest and coupled with volumetric measures of cerebral blood flow (duplex ultrasound) to quantify resting cerebral metabolic parameters. l-NMMA elicited a 30% reduction in the peak (P = 0.01), but not average (P = 0.11), NVC response. Neither phenylephrine nor haemodilution influenced NVC. Nitric oxide signalling is integral to NVC in humans, providing a new direction for research into pharmacological treatment of humans with dementia.",2020,"L-NMMA elicited a 30% reduction in the peak (P = 0.01), but not average (P = 0.11), NVC response.","['humans with dementia', 'young healthy males']","['bolus & subsequent 50\xa0μg\xa0kg -1', 'arginine', 'phenylephrine', 'saline (placebo) and the non-selective competitive nitric oxide synthase inhibitor N G  -monomethyl', 'phenylephrine infusion', 'L']","['NVC response', 'cerebral blood flow (duplex ultrasound', 'blood pressure changes on NVC']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}]",,0.0290705,"L-NMMA elicited a 30% reduction in the peak (P = 0.01), but not average (P = 0.11), NVC response.","[{'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Hoiland', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Caldwell', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Connor A', 'Initials': 'CA', 'LastName': 'Howe', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Nowak-Flück', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Stacey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, CF37 4BB, UK.'}, {'ForeName': 'Damian M', 'Initials': 'DM', 'LastName': 'Bailey', 'Affiliation': 'Neurovascular Research Laboratory, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, CF37 4BB, UK.'}, {'ForeName': 'Julian F R', 'Initials': 'JFR', 'LastName': 'Paton', 'Affiliation': 'Department of Physiology, Faculty of Medical & Health Sciences, University of Auckland, Park Road, Grafton, Auckland, 1142, New Zealand.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Sciences), The University of Western Australia, Nedlands, Western Australia, 6009, Australia.'}, {'ForeName': 'Mypinder S', 'Initials': 'MS', 'LastName': 'Sekhon', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, Vancouver General Hospital, West 12th Avenue, University of British Columbia, Vancouver, BC, V5Z 1M9, Canada.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Macleod', 'Affiliation': 'Human Pharmacology & Physiology Lab, Department of Anesthesiology, Duke University Medical Center, Durham, NC, 27708, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, BC, V1V 1V7, Canada.'}]",The Journal of physiology,['10.1113/JP280162']
1768,32794125,Microbiota of Four Tissue Types in American Alligators (Alligator mississippiensis) Following Extended Dietary Selenomethionine Exposure.,"Selenium represents an essential trace nutrient that is necessary for biological functions. Deficiencies can induce disease, but excess can induce toxicity. Selenium deficiency is a major concern in underdeveloped countries, while also posing as a toxic pollutant in waterways surrounding landfills, agricultural areas, and fossil fuel production sites. We examined the microbiome of selenomethionine (SeMet) fed American alligators (Alligator mississippiensis) at the beginning and end of a 7-week exposure experiment. Alligators were randomly divided into three groups: control and 1000 or 2000 ppm SeMet. DNA from before exposure (oral and cloaca swabs) and post-exposure (oral, cloaca, small & large intestines) sampling were extracted and amplified for bacterial 16 s rRNA. While treatment did not seem to have much effect, we observed a predominance of Fusobacteriaceae and Porpyromonodaceae across all tissue types. Cetobacterium and Clostridium are the most abundant genera as potential indicators of the aquatic and carrion feeding lifestyle of alligators.",2020,"While treatment did not seem to have much effect, we observed a predominance of Fusobacteriaceae and Porpyromonodaceae across all tissue types.",['Microbiota of Four Tissue Types in American Alligators (Alligator mississippiensis'],"['Selenium', 'control and 1000 or 2000\xa0ppm SeMet', 'selenomethionine (SeMet) fed American alligators (Alligator mississippiensis']",[],"[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0019633', 'cui_str': 'Tissue Typing'}, {'cui': 'C0327167', 'cui_str': 'Alligator mississippiensis'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0034616', 'cui_str': 'Selenomethionine Se 75'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0327167', 'cui_str': 'Alligator mississippiensis'}]",[],,0.0130584,"While treatment did not seem to have much effect, we observed a predominance of Fusobacteriaceae and Porpyromonodaceae across all tissue types.","[{'ForeName': 'Troy J', 'Initials': 'TJ', 'LastName': 'Kieran', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Goodman', 'Affiliation': 'Department of Poultry Science, University of Georgia, 30602, Athens, GA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Finger', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Thomas', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Hamilton', 'Affiliation': 'Savannah River Ecology Laboratory, University of Georgia, 29802, Aiken, SC, USA.'}, {'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Tuberville', 'Affiliation': 'Savannah River Ecology Laboratory, University of Georgia, 29802, Aiken, SC, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Glenn', 'Affiliation': 'Department of Environmental Health Science, University of Georgia, Athens, GA, 30602, USA. travisg@uga.edu.'}]",Bulletin of environmental contamination and toxicology,['10.1007/s00128-020-02961-3']
1769,32757065,Effect of carbohydrate-protein supplementation on endurance training adaptations.,"PURPOSE


To examine the influence of post-exercise protein feeding upon the adaptive response to endurance exercise training.
METHODS


In a randomised parallel group design, 25 healthy men and women completed 6 weeks of endurance exercise training by running on a treadmill for 30-60 min at 70-75% maximal oxygen uptake (VO 2max ) 4 times/week. Participants ingested 1.6 g per kilogram of body mass (g kg BM -1 ) of carbohydrate (CHO) or an isocaloric carbohydrate-protein solution (CHO-P; 0.8 g carbohydrate kg BM -1  + 0.8 g protein kg BM -1 ) immediately and 1 h post-exercise. Expired gas, blood and muscle biopsy samples were taken at baseline and follow-up.
RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 L min -1  and 3.0 ± 2 mL kg -1  min -1 , respectively). No change occurred in plasma albumin concentration from baseline to follow-up with CHO-P (4.18 ± 0.18 to 4.23 ± 0.17 g dL -1 ) or CHO (4.17 ± 0.17 to 4.12 ± 0.22 g dL -1 ; interaction: p > 0.05). Mechanistic target of rapamycin (mTOR) gene expression was up-regulated in CHO-P (+ 46%; p = 0.025) relative to CHO (+ 4%) following exercise training.
CONCLUSION


Post-exercise protein supplementation up-regulated the expression of mTOR in skeletal muscle over 6 weeks of endurance exercise training. However, the magnitude of improvement in VO 2max  was similar between groups.",2020,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ",['25 healthy men and women completed 6\xa0weeks of'],"['endurance exercise training by running on a treadmill for 30-60\xa0min at 70-75% maximal oxygen uptake', 'endurance exercise training', 'carbohydrate (CHO', 'carbohydrate-protein supplementation', 'isocaloric carbohydrate-protein solution (CHO-P; 0.8\xa0g carbohydrate kg', 'L']","['BM -1', 'plasma albumin concentration', 'VO 2max', 'Mechanistic target of rapamycin (mTOR) gene expression', 'endurance training adaptations', 'Expired gas, blood and muscle biopsy samples']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample'}]",25.0,0.046735,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ","[{'ForeName': 'Abdullah F', 'Initials': 'AF', 'LastName': 'Alghannam', 'Affiliation': 'Lifestyle and Health Research Center, Health Sciences Research Center, Princess Nourah Bint Abdulrahman University, Riyadh, 84428, Saudi Arabia. AFAlghannam@pnu.edu.sa.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Jedrzejewski', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lemon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Byers', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, SW15 4JD, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bilzon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04450-1']
1770,32761130,Corrigendum to: A Randomized Clinical Trial to Compare Plasmodium falciparum Gametocytemia and Infectivity After Blood-Stage or Mosquito Bite-Induced Controlled Malaria Infection.,,2020,,[],[],[],[],[],[],,0.050869,,"[{'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Alkema', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Isaie J', 'Initials': 'IJ', 'LastName': 'Reuling', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Gerdie M', 'Initials': 'GM', 'LastName': 'de Jong', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Kjerstin', 'Initials': 'K', 'LastName': 'Lanke', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Luc E', 'Initials': 'LE', 'LastName': 'Coffeng', 'Affiliation': 'Department of Public Health, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'van Gemert', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marga', 'Initials': 'M', 'LastName': 'van de Vegte-Bolmer', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Quirijn', 'Initials': 'Q', 'LastName': 'de Mast', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ivinson', 'Affiliation': 'PATH Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Ockenhouse', 'Affiliation': 'PATH Malaria Vaccine Initiative, Washington, DC, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McCarthy', 'Affiliation': 'Clinical Tropical Medicine Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sauerwein', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa428']
1771,32757879,"Prospective, Randomized, Comparative, Multicenter Study of the Hybrid Ultrasonic Advanced Bipolar Device and the Ultrasonic Coagulating Shears in Open Thyroidectomy.","Background.  The hybrid ultrasonic advanced bipolar device (HUB) that integrates ultrasonic energy and advanced bipolar energy was recently developed and applied to thyroid surgery. The purpose of this study was to compare the efficacy and safety of HUB and ultrasonic coagulating shears for open thyroidectomy.  Methods.  A total of 200 patients were enrolled from April to September 2017 in this prospective, randomized, multicenter study. Patients were randomly assigned to an ultrasonic group (n = 101) or a hybrid group (n = 99).  Results.  Operation times were similar in the 2 study groups, that is, 54.2 ± 25.2 minutes in the ultrasonic group and 50.2 ± 21.6 minutes in the hybrid group. Postoperative surgical results and morbidities were no different in the 2 groups. However, the total amount of bleeding was significantly less in the hybrid group (13.0 ± 17.7 mg vs 8.6 ± 11.5 mg;  P  = .042).  Conclusions.  Our study showed that there was no significant difference between the 2 groups in postoperative surgical results and morbidity. The total bleeding amount was significantly less in the hybrid group. The study shows that HUB is comparable to the ultrasonic coagulating shears in terms of efficacy and safety during thyroid surgery.",2020,The study shows that HUB is comparable to the ultrasonic coagulating shears in terms of efficacy and safety during thyroid surgery.,['200 patients were enrolled from April to September 2017'],"['ultrasonic coagulating shears', 'HUB and ultrasonic coagulating shears', 'ultrasonic group', 'Hybrid Ultrasonic Advanced Bipolar Device and the Ultrasonic Coagulating Shears', 'hybrid ultrasonic advanced bipolar device (HUB']","['Postoperative surgical results and morbidities', 'efficacy and safety', 'postoperative surgical results and morbidity', 'total bleeding amount', 'Operation times', 'total amount of bleeding']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",200.0,0.0183842,The study shows that HUB is comparable to the ultrasonic coagulating shears in terms of efficacy and safety during thyroid surgery.,"[{'ForeName': 'Wan Wook', 'Initials': 'WW', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, School of Medicine, 65672Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Jihyoung', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, School of Medicine, 37976Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Young San', 'Initials': 'YS', 'LastName': 'Jeon', 'Affiliation': 'Department of Surgery, Goo Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Insoo', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Daegu Fatima Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Young Ju', 'Initials': 'YJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, School of Medicine, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Jungeun', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, School of Medicine, 37976Keimyung University, Daegu, Republic of Korea.'}, {'ForeName': 'Jehyung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Goo Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Jin Gu', 'Initials': 'JG', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}, {'ForeName': 'Ralph P', 'Initials': 'RP', 'LastName': 'Tufano', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Su Hwan', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}]",Surgical innovation,['10.1177/1553350620949000']
1772,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2020,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
1773,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1774,31823135,Long-term analyses of spastic muscle behavior in chronic poststroke patients after near-infrared low-level laser therapy (808 nm): a double-blinded placebo-controlled clinical trial.,"Stroke results in impairment of basic motor functions, such as muscle weakness in limbs affected by spasticity, leading to peripheral fatigue and impaired functionality. The clinical use of photobiomodulation therapy (PBMT) has provided major advances in the treatment of muscular disorders and prevention of muscle fatigue. The aim of this study was to analyze the effects of two distinct therapies in biceps spasticity of chronic hemiparetic patients. We analyzed range of elbow motion, torque, electromyography, and mean spectral frequency after 10 sessions of PBMT (Laser 100 mW, 808 nm, 159.24 J/cm 2 /point, 5 J/point); PBMT active or placebo was associated with exoskeleton-assisted functional treatment. A double-blind placebo-controlled sequential clinical trial was conducted with 12 healthy volunteers and 15 poststroke patients who presented upper-limb spasticity. The healthy volunteers performed only the evaluation protocol, and the poststroke volunteers participated in three consecutive phases (PBMT, PBMT + exoskeleton, placebo + PBMT) with a washout period of 4 weeks between each phase. We could observe significant increases in range of elbow motion after PBMT from 57.7 ± 14 to 84.3 ± 27.6 degrees (p < 0.001). The root mean square (RMS) values also increased after PBMT + exoskeleton from 23.2 ± 15 to 34.9 ± 21 μV (p = 0.0178). Our results suggest that the application of PBMT may contribute to an increased range of elbow motion and muscle fiber recruitment, increases in muscle strength, and, hence, to increase signal conduction on spastic muscle fibers in spastic patients.",2020,The clinical use of photobiomodulation therapy (PBMT) has provided major advances in the treatment of muscular disorders and prevention of muscle fatigue.,"['spastic patients', 'chronic hemiparetic patients', 'healthy volunteers performed only the evaluation protocol, and the poststroke volunteers participated in three', 'chronic poststroke patients after', '12 healthy volunteers and 15 poststroke patients who presented upper-limb spasticity']","['placebo', 'photobiomodulation therapy (PBMT', 'PBMT ', 'near-infrared low-level laser therapy', 'consecutive phases (PBMT, PBMT + exoskeleton, placebo + PBMT', 'PBMT active or placebo']","['range of elbow motion', 'root mean square (RMS) values', 'elbow motion, torque, electromyography, and mean spectral frequency']","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",12.0,0.12055,The clinical use of photobiomodulation therapy (PBMT) has provided major advances in the treatment of muscular disorders and prevention of muscle fatigue.,"[{'ForeName': 'Marcele Florêncio', 'Initials': 'MF', 'LastName': 'das Neves', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Diane Cristina', 'Initials': 'DC', 'LastName': 'Aleixo', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Izabela Santos', 'Initials': 'IS', 'LastName': 'Mendes', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Fernanda Púpio Silva', 'Initials': 'FPS', 'LastName': 'Lima', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Renata Amadei', 'Initials': 'RA', 'LastName': 'Nicolau', 'Affiliation': 'Laboratório de Terapia Fotodinâmica - Instituto de Pesquisa & Desenvolvimento, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Emilia Angela Loschiavo', 'Initials': 'EAL', 'LastName': 'Arisawa', 'Affiliation': 'Laboratório de Imunologia - Instituto de Pesquisa e Desenvolvimento, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}, {'ForeName': 'Rodrigo Alvaro Brandão', 'Initials': 'RAB', 'LastName': 'Lopes-Martins', 'Affiliation': 'Laboratório de Biofotônica e Terapêutica Experimental - Instituto de Pesquisa & Desenvolvimento, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil. ralopesmartins@gmail.com.'}, {'ForeName': 'Mário Oliveira', 'Initials': 'MO', 'LastName': 'Lima', 'Affiliation': 'Laboratório de Engenharia de Reabilitação Sensório Motora, Faculdade de Ciências da Saúde, Universidade do Vale do Paraíba, São José dos Campos, SP, Brasil.'}]",Lasers in medical science,['10.1007/s10103-019-02920-3']
1775,32768874,Intermittent Motivational Interviewing and Transdiagnostic CBT for Anxiety: A Randomized Controlled Trial.,"Recent meta-analytic findings suggest that Motivational Interviewing (MI) used as an adjunct to Cognitive Behavior Therapy (CBT) for anxiety disorders improves overall treatment outcomes (Marker & Norton, 2018). However, when used as a prelude to CBT, MI significantly increases the length of treatment and numerous studies note that the effectiveness of pre-treatment MI subsides over time. The current study adapted an already established 12-session transdiagnostic CBT protocol (tCBT, Norton, 2012) to include one hour of MI spread across four sessions of tCBT (sessions 1, 3, 8, and 10) at 15 minutes each, with the option of including additional MI if resistance arose in therapy. Thirty-six treatment seeking adults with principal anxiety disorder diagnosis were randomly assigned to receive intermittent MI and tCBT (iMI + tCBT) or tCBT and psychoeducation. Results indicated that the iMI + tCBT condition significantly outperformed the tCBT condition on several primary outcome variables. While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning. These effects were not moderated by baseline motivation or baseline ambivalence. The study also found that the iMI + tCBT condition showed significantly greater improvement to comorbid conditions and greater reduction in self-report depressive symptoms. The inclusion of MI did not impact participant drop out. This study provides further support for integrating MI and tCBT and highlights that even small doses of MI can improve treatment outcomes, without increasing length of usual therapy. Limitations and future research options are also discussed.",2020,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","['for Anxiety', 'Thirty-six treatment seeking adults with principal anxiety disorder diagnosis']","['Intermittent Motivational Interviewing and Transdiagnostic CBT', 'Cognitive Behavior Therapy (CBT', 'Motivational Interviewing (MI', 'intermittent MI and tCBT (iMI\u202f+\u202ftCBT) or tCBT and psychoeducation']","['self-report depressive symptoms', ""composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning""]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",36.0,0.0207886,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Marker', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Bronte E', 'Initials': 'BE', 'LastName': 'Corbett', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'Monash University, Australia. Electronic address: Peter.Norton@monash.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102276']
1776,32768992,Cannabis use in patients 3 months after ceasing nabiximols for the treatment of cannabis dependence: Results from a placebo-controlled randomised trial.,"INTRODUCTION AND AIMS


Previous studies suggest cannabinoid agonist treatment is effective in reducing cannabis use in dependent treatment seekers, however few studies have reported on post-treatment outcomes. We examine cannabis use outcomes 12 weeks after cessation of treatment from a randomised placebo-controlled trial of nabiximols for the treatment of cannabis dependence.
METHOD


128 participants received either nabiximols (n = 61) or placebo (n = 67) for 12 weeks, in combination with psychosocial interventions. Self-reported number of days of cannabis use in the previous 28 days was measured at baseline, 4, 8, and 12 weeks (end of treatment) and again at 24 weeks (3 months after treatment ceased). Urinalysis was used to confirm self-report data at Week 24 interview.
RESULTS


A factorial mixed-effects model for repeated measures regression revealed that the nabiximols group used cannabis on 6.8 fewer days in the previous 28 days at week 12 (end of treatment) than the placebo group (p = 0.002, CI: 2.1,11.4), and 6.7 fewer days in the previous 28 days at the week-24 follow-up than the placebo group (p = 0.006, CI: 1.4,12.1). A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
DISCUSSIONS AND CONCLUSIONS


The benefits of treatment incorporating nabiximols with psychosocial interventions in reducing cannabis use appears to persist for up to 3 months after the cessation of treatment. A stepped care model of treatment is proposed.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12616000103460) https://www.anzctr.org.au.",2020,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","['patients 3 months after ceasing nabiximols for the treatment of cannabis dependence', '128 participants received either nabiximols (n = 61) or']","['nabiximols with psychosocial interventions', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}]","[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],128.0,0.260502,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia. Electronic address: Nicholas.lintzeris@health.nsw.gov.au.'}, {'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia; Priority Research Centre for Brain and Mental Health, School of Medicine and Public Health, University of Newcastle, NSW, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'University of New South Wales, NSW, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Mcgregor', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'University of Tasmania, TAS, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; University of New South Wales, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug Health, Western Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kevin', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108220']
1777,32781894,Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS).,"INTRODUCTION


Despite low mortality, cardiac surgery patients may experience serious life-threatening post-operative complications, often due to extracorporeal circulation and reperfusion. Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
METHODS


The COMICS trial is a multi-centre, international, two-group parallel randomised controlled trial testing whether type II, III or IV minimally invasive extracorporeal circulation is effective and cost-effective compared to conventional extracorporeal circulation in patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting + aortic valve replacement. Randomisation (1:1 ratio) is concealed and stratified by centre and surgical procedure. The primary outcome is a composite of 12 serious complications, objectively defined or adjudicated, 30 days after surgery. Secondary outcomes (at 30 days) include other serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90 days).
STATUS OF THE TRIAL


Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020). The recruitment rate from 01 April 2019 to 31 March 2020 was 40-50 patients/month. About 80% have had coronary artery bypass grafting only. Adherence to allocation is good.
CONCLUSIONS


The trial is feasible but criteria for progressing to a full trial were not met on time. The Trial Steering and Data Monitoring Committees have recommended that the trial should currently continue.",2020,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","['patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting\u2009+\u2009aortic valve replacement', 'patients undergoing cardiac surgery', 'Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020']","['Conventional versus minimally invasive extracorporeal circulation', 'Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation', 'conventional extracorporeal circulation']","['composite of 12 serious complications', 'serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90\u2009days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.169333,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Perfusion,['10.1177/0267659120946731']
1778,32781913,Effect of shoe cushioning on landing impact forces and spatiotemporal parameters during running: results from a randomized trial including 800+ recreational runners.,"Abstract  In a recent randomized trial including 800+ recreational runners, injury risk was lower in those who received the Soft shoe version compared to those using the Hard version (Hazard ratio = 1.52; 95% Confidence Interval = 1.07-2.16). Here, we investigated the effect of shoe cushioning on ground reaction forces (GRF) and spatiotemporal parameters in the same cohort, with a special focus on Vertical Impact Peak Force (VIPF) and Vertical Instantaneous Loading Rate (VILR). Healthy runners ( n  = 848) randomly received one of two shoe prototypes that differed only in their cushioning properties (Global stiffness: 61 ± 3 and 95 ± 6 N/mm in the Soft and Hard versions, respectively). Participants were tested on an instrumented treadmill at their preferred running speed. GRF data was recorded over 2 min. VIPF was higher in the Soft shoe group compared to the Hard shoe group (1.53 ± 0.21 vs. 1.44 ± 0.23 BW, respectively;  p  < 0.001). However, the proportion of steps with detectable VIPF was lower in the Soft shoe group (84 vs. 97%, respectively;  p  < 0.001) and Time to VIPF was longer (46.9 ± 8.5 vs. 43.4 ± 7.4 milliseconds, respectively;  p  < 0.001). No significant differences were observed for VILR (60.1 ± 13.8 vs. 58.9 ± 15.6 BW/s for Soft and Hard shoe group, respectively;  p  = 0.070) or any other kinetic variable. These results show that the beneficial effect of greater shoe cushioning on injury risk in the present cohort is not associated with attenuated VIPF and VILR. These GRF metrics may be inappropriate markers of the shoe cushioning-injury risk relationship, while delayed VIPF and the proportion of steps displaying a VIPF could be more relevant.  Trial registration:  ClinicalTrials.gov identifier: NCT03115437..",2020,"No significant differences were observed for VILR (60.1±13.8 vs. 58.9±15.6 BW/s for Soft and Hard shoe group, respectively; p=0.070) or any other kinetic variable.","['800+ recreational runners', 'Healthy runners (n=848']","['instrumented treadmill at their preferred running speed', 'shoe cushioning']","['proportion of steps with detectable VIPF', 'VILR', 'Vertical Impact Peak Force (VIPF) and Vertical Instantaneous Loading Rate (VILR', 'Time to VIPF', 'VIPF', 'GRF data', 'injury risk']","[{'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0582456', 'cui_str': 'At risk for injury'}]",848.0,0.0967385,"No significant differences were observed for VILR (60.1±13.8 vs. 58.9±15.6 BW/s for Soft and Hard shoe group, respectively; p=0.070) or any other kinetic variable.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Malisoux', 'Affiliation': 'Physical Activity, Sport & Health research group, Luxembourg Institute of Health, Luxembourg, Grand-Duchy of Luxembourg.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delattre', 'Affiliation': ""Movement Sciences Department, Decathlon Sports Lab, Villeneuve d'Ascq, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Human motion, Orthopaedic, Sports medicine and Digital methods unit, Luxembourg Institute of Health, Luxembourg, Grand-Duchy of Luxembourg.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gette', 'Affiliation': 'Human motion, Orthopaedic, Sports medicine and Digital methods unit, Luxembourg Institute of Health, Luxembourg, Grand-Duchy of Luxembourg.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Urhausen', 'Affiliation': 'Sports Clinic, Centre Hospitalier de Luxembourg, Luxembourg, Grand-Duchy of Luxembourg.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Theisen', 'Affiliation': 'ALAN - Maladies Rares Luxembourg, Bascharage, Grand-Duchy of Luxembourg.'}]",European journal of sport science,['10.1080/17461391.2020.1809713']
1779,32787978,Study protocol on Enhanced Primary Healthcare (EnPHC) interventions: a quasi-experimental controlled study on diabetes and hypertension management in primary healthcare clinics.,"AIM


This paper describes the study protocol, which aims to evaluate the effectiveness of a multifaceted intervention package called 'Enhanced Primary Healthcare' (EnPHC) on the process of care and intermediate clinical outcomes among patients with Type 2 diabetes mellitus (T2DM) and hypertension. Other outcome measures include patients' experience and healthcare providers' job satisfaction.
BACKGROUND


In 2014, almost two-thirds of Malaysia's adult population aged 18 years or older had T2DM, hypertension or hypercholesterolaemia. An analysis of health system performance from 2016 to 2018 revealed that the control and management of diabetes and hypertension in Malaysia was suboptimal with almost half of the patients not diagnosed and just one-quarter of patients with diabetes appropriately treated. EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
METHODS


This is a quasi-experimental controlled study which involves 20 intervention and 20 control clinics in two different states in Malaysia, namely Johor and Selangor. The clinics in the two states were matched and randomly allocated to 'intervention' and 'control' arms. The EnPHC framework targets different levels from community to primary healthcare clinics and integrated referral networks.Data are collected via a retrospective chart review (RCR), patient exit survey, healthcare provider survey and an intervention checklist. The data collected are entered into tablet computers which have installed in them an offline survey application. Interrupted time series and difference-in-differences (DiD) analyses will be conducted to report outcomes.",2020,"EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
","['diabetes and hypertension management in primary healthcare clinics', '20 control clinics in two different states in Malaysia, namely Johor and Selangor', 'diagnosed patients', ""In 2014, almost two-thirds of Malaysia's adult population aged 18 years or older had T2DM, hypertension or hypercholesterolaemia"", 'patients with Type 2 diabetes mellitus (T2DM) and hypertension']","[""multifaceted intervention package called 'Enhanced Primary Healthcare' (EnPHC""]","[""patients' experience and healthcare providers' job satisfaction""]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",,0.0247709,"EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
","[{'ForeName': 'Sheamini', 'Initials': 'S', 'LastName': 'Sivasampu', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Xin Rou', 'Initials': 'XR', 'LastName': 'Teh', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Yvonne Mei Fong', 'Initials': 'YMF', 'LastName': 'Lim', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Su Miin', 'Initials': 'SM', 'LastName': 'Ong', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Swee Hung', 'Initials': 'SH', 'LastName': 'Ang', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Masliyana', 'Initials': 'M', 'LastName': 'Husin', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Noraziani', 'Initials': 'N', 'LastName': 'Khamis', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Faeiz Syezri Adzmin', 'Initials': 'FSA', 'LastName': 'Jaafar', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Wen Jun', 'Initials': 'WJ', 'LastName': 'Wong', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Shanmugam', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Siti Aminah', 'Initials': 'SA', 'LastName': 'Ismail', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Sarah Hui Li', 'Initials': 'SHL', 'LastName': 'Pang', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Nazrila Hairizan', 'Initials': 'NH', 'LastName': 'Nasir', 'Affiliation': 'Family Health Development Division, Ministry of Health Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Mohd Safiee', 'Initials': 'MS', 'LastName': 'Ismail', 'Affiliation': 'Family Health Development Division, Ministry of Health Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Kusuma', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Ross-Degnan', 'Affiliation': 'Harvard Medical School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Rifat', 'Initials': 'R', 'LastName': 'Atun', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Primary health care research & development,['10.1017/S1463423620000250']
1780,32784231,Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial.,"BACKGROUND


Low-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.
OBJECTIVE


Determine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.
DESIGN


Double-blinded randomized control trial.
METHODS


Patients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in  > 1 myotome and ≥50% pain reduction on the numerical scale.
RESULTS


120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
CONCLUSION


Low-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov (NCT03127137); December 26, 2017.",2020,"Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
","['Patients with cervical radicular pain scheduled for CIESI were enrolled', 'cervical interlaminar epidural injections', '120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60']","['low-dose lidocaine', 'lidocaine', 'lidocaine (CIESI-L) or saline (CIESI-S']","['pain reduction', 'post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in  > 1 myotome and ≥50%\u2009pain reduction on the numerical scale', 'objective upper extremity strength and immediate pain relief', 'postprocedural upper extremity weakness', 'risk of post-CIESI myotomal weakness', 'Myotomal strength', 'likelihood of immediate, meaningful pain relief', 'pain and post-pain scores', 'proportion of participants with postprocedural weakness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0231043', 'cui_str': 'Structure of myotome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444463', 'cui_str': 'Myotomal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.725452,"Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'McCormick', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Orthopedic Surgery, University of Utah Hospital, Salt Lake City, Utah, USA zmccormi@gmail.com.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Burnham', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'Shellie', 'Initials': 'S', 'LastName': 'Cunningham', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Kendall', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bougie', 'Affiliation': 'Department of Anesthesiology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Walega', 'Affiliation': 'Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101598']
1781,32785689,Markers of Iron Flux during Testosterone-Mediated Erythropoiesis in Older Men with Unexplained or Iron-Deficiency Anemia.,"CONTEXT


Testosterone treatment of hypogonadal men improves their hemoglobin, but the mechanism is not understood.
OBJECTIVE


To investigate possible mechanisms by which testosterone stimulates erythropoiesis in hypogonadal older men with unexplained or iron-deficiency anemia.
DESIGN


The Anemia Trial of The Testosterone Trials, a placebo-controlled study in older, hypogonadal men.
SETTING


Twelve academic medical centers.
PARTICIPANTS


A total of 95 hypogonadal men (testosterone < 275 ng/mL) ≥65 years with anemia (hemoglobin < 12.7 g/dL). They were classified as having unexplained (n = 58) or iron deficiency anemia (n = 37).
INTERVENTION


Testosterone or placebo gel for 1 year.
MAIN OUTCOME MEASURES


Markers of iron metabolism during the first 3 months of treatment.
RESULTS


Testosterone replacement significantly (P < 0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% confidence interval, 0.31-0.85). Testosterone replacement tended to increase hemoglobin in the 37 men who had iron deficiency (0.38 g/dL; -0.19, 0.95), but the response was more variable and not statistically significant (P = 0.19). In men with unexplained anemia, testosterone replacement suppressed hepcidin (-8.2 ng/mL; -13.7, -2.7; P = 0.004) and ferritin (-19.6 µg/L; -32.8, -6.3; P = 0.004), but in men with iron deficiency, testosterone replacement did not. The decrease in hepcidin was moderately correlated with the increase in hemoglobin in the men with unexplained anemia (correlation coefficient -0.35, P = 0.01) but not in those with iron deficiency anemia (correlation coefficient -0.07, P = 0.73).
CONCLUSIONS


Testosterone replacement of older hypogonadal men with unexplained anemia stimulates erythropoiesis associated with increased iron mobilization. This effect appears to be attenuated by iron deficiency.",2020,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","['older, hypogonadal men', 'older hypogonadal men with unexplained anemia stimulates erythropoiesis', 'They were classified as having unexplained (58) or iron deficiency anemia (37', 'hypogonadal older men with unexplained or iron-deficiency anemia', 'Older Men with Unexplained or Iron-Deficiency Anemia', 'hypogonadal men', 'Twelve academic medical centers', '95 hypogonadal men (testosterone <275 ng/mL) ≥65 years with anemia (hemoglobin <12.7 g/dL']","['Testosterone-Mediated Erythropoiesis', 'testosterone', 'Testosterone replacement', 'Testosterone or placebo gel', 'placebo']","['hemoglobin', 'Markers of iron metabolism', 'unexplained anemia', 'hepcidin']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",95.0,0.520846,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Artz', 'Affiliation': 'City of Hope, Department of Hematology and Hematopoietic Cell Transplantation, Duarte, California.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke University Medical Center, Center for the Study of Aging, Durham, North Carolina.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa521']
1782,32790537,Four weeks of high-intensity interval training (HIIT) improve the cardiometabolic risk profile of overweight patients with type 1 diabetes mellitus (T1DM).,"This study investigated the effects of a four-week HIIT intervention on the cardiometabolic risk profile, liver fat content, insulin requirement, hypoglycaemia, physical fitness, and health-related quality of life in patients with T1DM. A supervised exercise intervention with baseline to follow-up comparison between overweight (BMI = 28.6 ± 2.1 kg/m 2 ) and normal weight (BMI = 23.2 ± 1.40 kg/m 2 ) T1DM patients was performed. Eleven overweight (age = 40.7 ± 14.3 years) and 11 normal weight (age = 42.2 ± 15.5 years) T1DM patients performed a four-week, low-volume, all-out cycling HIIT (4-6 bouts, work/relief ratio 1:1) twice weekly. HIIT lowered low-density lipoprotein and uric acid levels in overweight patients by up to 10.5% (vs. normal weight,  p ≤0.0312). HbA1c, high-density lipoprotein, and triglyceride levels did not change in any of the groups. Participants' maximal exercise capacity and power output at individual anaerobic lactate threshold increased to an equal extend of up to 10% ( p ≤0.0002) in both groups. During the intervention, participants used fewer daily bolus insulin (-5.22 ± 12.80%) and less total units of insulin (-4.42 ± 10.20%,  p ≤0.023) compared to the pre-intervention period with no between-group difference. Overall, the average daily number of hypoglycaemias increased from 0.90 ± 0.56-1.08 ± 0.63 during the intervention ( p  = 0.033). SF-36 subscales showed higher scores after the intervention, with a significant improvement of ""role limitations due to physical problems"" ( p <0.05) for both groups. We conclude that in T1DM, HIIT may exert beneficial effects on physical fitness, insulin requirement and health-related quality of life. Of note, beneficial HIIT effects on the cardiometabolic risk profile in T1DM may be larger in overweight T1DM patients.  Highlights  Patients with type 1 diabetes mellitus (T1DM) have an elevated risk for cardiovascular disease. Physical exercise is effective to reduce cardiovascular risk factors in T1DM. The beneficial effects of high-intensity interval training (HIIT) on cardiometabolic risk factors in overweight T1DM patients has not been studied. We found that already four weeks of low-volume HIIT improved the cardiometabolic risk profile by lowering low-density lipoprotein (LDL) and uric acid levels predominantly in overweight T1DM patients. Overall, HIIT improved physical fitness in terms of maximal exercise capacity and power output at the individual anaerobic lactate threshold. Compared to the pre-intervention period, patients required fewer total units of insulin during the HIIT intervention. The average number of hypoglycaemias increased during the HIIT intervention. We conclude that in T1DM, HIIT exerts beneficial effects on physical fitness and insulin requirement. Of note, beneficial HIIT effects on the cardiometabolic risk profile may be larger in overweight T1DM patients.",2020,"SF-36 subscales showed higher scores after the intervention, with a significant improvement of 'role limitations due to physical problems' (p<0.05) for both groups.","['patients with T1DM', 'Eleven overweight (age = 40.7±14.3 years) and 11 normal weight (age = 42.2±15.5 years', 'overweight T1DM patients', 'overweight patients with type 1 diabetes mellitus (T1DM']","['HIIT intervention', 'supervised exercise intervention', 'high-intensity interval training (HIIT']","['cardiometabolic risk profile, liver fat content, insulin requirement, hypoglycaemia, physical fitness, and health-related quality of life', 'HIIT lowered low-density lipoprotein and uric acid levels', 'total units of insulin', 'physical fitness, insulin requirement and health-related quality of life', 'average daily number of hypoglycaemias', 'maximal exercise capacity and power output at individual anaerobic lactate threshold', 'cardiometabolic risk profile', 'HbA1c, high-density lipoprotein, and triglyceride levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",11.0,0.0311131,"SF-36 subscales showed higher scores after the intervention, with a significant improvement of 'role limitations due to physical problems' (p<0.05) for both groups.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Minnebeck', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vorona', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zinn', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Gellner', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hinder', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Stefan-Martin', 'Initials': 'SM', 'LastName': 'Brand', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Iyad', 'Initials': 'I', 'LastName': 'Kabar', 'Affiliation': 'Internal Medicine B, Department of Diabetology and Endocrinology, University Hospital Muenster, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Alten', 'Affiliation': 'Department of Ophthalmology, University of Muenster Medical Center, Muenster, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schmitz', 'Affiliation': 'Institute of Sports Medicine, Molecular Genetics of Cardiovascular Disease, University Hospital Muenster, Muenster, Germany.'}]",European journal of sport science,['10.1080/17461391.2020.1810782']
1783,32791610,[Efficacy analysis of use of absorbable sinus drug stents in functional endoscopic sinus surgery].,"Objective: To explore the efficacy of functional endoscopic sinus surgery（FESS） with an absorbable sinus drug stent in the treatment of chronic sinusitis.  Method: 107 patients with chronic sinusitis who underwent FESS were divided into two groups: 58 patients were set as stent group who were treated with sinus drug elution during surgery; 49 patients who did not receive a sinus drug stent were included in the non-stent group. The same postoperative treatment were used in the two groups. The patients were followed up for 1 month and reviewed 3 months after surgery. Efficacy is mainly evaluated by endoscopy. The evaluation indicators include whether the sinus mucosa is congested and edema, whether there is adhesion in the middle turbinate, whether vesicles or polyp-like mucosa are formed, whether the sinus mouth is stenosed or reoccluded, whether the sinus mucosa is epithelialized, and whether the patient had intervention after surgery.  Result: Stents were successfully implanted in 58 patients in the stent group. The difference of the above six indexes between the stent group and the non-stent group was statistically significant at 1 month after operation. The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the control group（ P <0.01）, the incidence of sinus mucosal epithelialization in the stent group was significantly higher than that in the non-stent group（ P <0.01）. The sinus mucosal epithelialization were all completed in both groups after 3 months of surgery. The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the non-stent group（ P <0.05 or  P <0.01）.  Conclusion: FESS combined with the absorption of sinus drug stents for the treatment of chronic sinusitis is safe and effective which can control the complications further after surgery while relieving the clinical symptoms of patients with sinusitis effectively.",2020,The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the non-stent group（ P <0.05 or  P <0.01）.  ,"['107 patients with chronic sinusitis who underwent FESS', 'functional endoscopic sinus surgery', '58 patients in the stent group']","['absorbable sinus drug stents', 'functional endoscopic sinus surgery（FESS） with an absorbable sinus drug stent', 'sinus drug elution during surgery; 49 patients who did not receive a sinus drug stent', 'FESS']","['sinus mucosal epithelialization', 'Efficacy', 'postoperative complication rate and postoperative intervention rate', 'incidence of sinus mucosal epithelialization']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",107.0,0.0199735,The postoperative complication rate and postoperative intervention rate were significantly lower in the stent group than in the non-stent group（ P <0.05 or  P <0.01）.  ,"[{'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}, {'ForeName': 'Longsheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}, {'ForeName': 'Junkang', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，the Affiliated Chaohu Hospital of Anhui Medical University，Heifei，238000，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.05.007']
1784,32791616,[Clinical observation of the anti-reflux treatment for the chronic pharyngitis patients with the reflux finding score from 8 to 10].,"Objective: To evaluate the anti-reflux treatment efficacy for the chronic pharyngitis patients with the reflux finding score（RFS） from 8-10.  Method: One hundred and twelve patients with clinical diagnosis of chronic pharyngitis and RFS score of 8-10 were randomly divided into control and treatment groups. The treantment group was given the proton pump inhibitors, gastrointestinal motility drugs and the traditional Chinese patent drugs（treatment group）. The control group was given only the traditional Chinese patent drugs（control group）.  Result: The visual analogue scale（VAS） of the patients in treatment group declined significantly after treatment. The efficacy of treatment group was significantly higher than that of control group（77.36% vs 30.61%,  P <0.01）.  Conclusion: For the patients with chronic pharyngitis with RFS 8-10, anti-reflux treatment should be used together with traditional Chinese patent drugs.",2020,"The efficacy of treatment group was significantly higher than that of control group（77.36% vs 30.61%,  P <0.01）.  ","['chronic pharyngitis patients with the reflux finding score from 8 to 10', 'chronic pharyngitis patients with the reflux finding score（RFS） from 8-10', 'One hundred and twelve patients with clinical diagnosis of chronic pharyngitis and RFS score of 8-10']","['proton pump inhibitors, gastrointestinal motility drugs and the traditional Chinese patent drugs（treatment group）', 'traditional Chinese patent drugs（control group）', 'anti-reflux treatment']",['visual analogue scale（VAS）'],"[{'cui': 'C0155825', 'cui_str': 'Chronic pharyngitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}]",112.0,0.0147976,"The efficacy of treatment group was significantly higher than that of control group（77.36% vs 30.61%,  P <0.01）.  ","[{'ForeName': 'Suyi', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'De', 'Initials': '', 'LastName': 'Lan', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Affiliated Hospital of Chengdu University，Chengdu，610081，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.05.013']
1785,32791618,[Evaluation of the effectiveness of immersive virtual reality-based exercise system for vestibular rehabilitation].,"Objective: To evaluate the efficacy of virtual reality technology assisted vestibular rehabilitation training（VRT） in treating chronic vestibular dysfunction patients.  Method: Ninety-eight vestibular dysfunction patients were assigned into the experimental group（ n =73） and the control group（ n =25） using mechanical sampling. The experimental group received immersive virtual reality assisted VRT treatment, while the control group received conventional VRT treatment. Chinese vertigo symptom scale（VSS-C） was used to measure vertigo symptoms before treatment and 12 weeks post-treatment. Balance feedback instrument was used to measure the center of pressure（COP）, maximum oscillation length（MOL） and COP envelope area（EA） which smaller numbers indicating better balance functions. Analysis of variance and Fisher's exact test were performed using SPSS 20.0 software to compare mean values and frequencies, respectively.  Result: ①Before treatment as baseline, there were no statistically significant differences in the total score of VSS-C scale, balance correlation and anxiety correlation score between the two groups. Total score and balance related score of experimental group were significantly different between before and after treatment（ P <0.01）, while no statistically significant difference in anxiety related scores. After treatment, there were statistically significant differences in total VSS-C score（ P <0.01） and balance correlation score（ P <0.05） between the two groups, while no statistically significant difference in anxiety correlation score. ②After 12 weeks of treatment, there were statistically significant differences between MOL and EA in open-eye state（ P <0.01）, but no statistically significant difference in close-eye state between two groups.  Conclusion: The introduction of VR technology by VRT can provide interesting interactions for patients in training and encourage patients to actively participate in various repetitive rehabilitation exercises that are boring, achieving good effect. The effect of VR on subjective balance rehabilitation without visual impairment is better than that of conventional.",2020,"Total score and balance related score of experimental group were significantly different between before and after treatment（ P <0.01）, while no statistically significant difference in anxiety related scores.","['vestibular rehabilitation', 'Method: Ninety-eight vestibular dysfunction patients', 'chronic vestibular dysfunction patients']","['virtual reality technology assisted vestibular rehabilitation training（VRT）', 'control group（ n =25） using mechanical sampling', 'VR', 'immersive virtual reality assisted VRT treatment', 'immersive virtual reality-based exercise system', 'conventional VRT treatment']","['MOL and EA', 'vertigo symptoms', 'anxiety related scores', 'total score of VSS-C scale, balance correlation and anxiety correlation score', 'anxiety correlation score', 'close-eye state', 'Total score and balance related score', 'total VSS-C score']","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1301808', 'cui_str': 'State'}]",98.0,0.0230778,"Total score and balance related score of experimental group were significantly different between before and after treatment（ P <0.01）, while no statistically significant difference in anxiety related scores.","[{'ForeName': 'Yuenong', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Yunwen', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}, {'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ""Institute of Otolaryngology Head and Neck Surgery，Guangzhou Medical University；Department of Otolaryngology Head and Neck Surgery，Otolaryngology Head and Neck Surgery Hospital of Guangzhou；Department of Otolaryngology Head and Neck Surgery，Guangzhou 12th People's Hospital，Guangzhou，510620，China.""}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.05.015']
1786,32791641,[Application of impulse-radio ultra-wideband radar as a non-contact portable monitoring device for the diagnosis of obstructive sleep apnea].,"Objective: To compare the effect of impulse-radio ultrawideband（IR-UWB） radar technology and polysomnography（PSG） in sleep assessment.  Method: A total of 79 OSA patients were randomly divided into two groups: 40 patients in group A received PSG and IR-UWB, and 39 patients in group B received micromovement sensitive mattress（MSM） and IR-UWB. Pearson correlation and ROC curve were used for statistics.  Result: AHI PSG and AHI MSM were significantly correlated with AHI IR-UWB（ r =0.91,  P ＝0.00;  r =0.92,  P ＝0.00）. Bland-Altman analysis showed that AHI IR-UWB value was highly consistent with AHI PSG value（95.00%）, and AHI IR-UWB value（97.44%）. The sensitivity and specificity of AHI IR-UWB compared with PSG were 70.40% and 89.90%, respectively. The area under ROC curve was 0.915.  Conclusion: IR-UWB has a high diagnostic value for adult OSA in terms of minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc. It is an economic and practical sleep evaluation tool.",2020,"IR-UWB has a high diagnostic value for adult OSA in terms of minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc.","['obstructive sleep apnea', '79 OSA patients']","['impulse-radio ultra-wideband radar', 'impulse-radio ultrawideband（IR-UWB） radar technology and polysomnography（PSG', 'PSG and IR-UWB, and 39 patients in group B received micromovement sensitive mattress（MSM） and IR-UWB']","['sensitivity and specificity of AHI IR-UWB', 'area under ROC curve', 'minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc', 'AHI IR-UWB value', 'AHI PSG and AHI MSM']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0338495', 'cui_str': 'Mixed sleep apnea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}]",79.0,0.0111517,"IR-UWB has a high diagnostic value for adult OSA in terms of minimum blood oxygen saturation, average blood oxygen saturation, average number of central sleep apnea, average number of complex sleep apnea, average heart rate, sleep efficiency, REM sleep duration, average AHI, etc.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Huidong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Feilun', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}, {'ForeName': 'Yanzhong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology，Qilu Hospital of Shandong University，NHC Key Laboratory of Otorhinolaryngology，Shandong University，Jinan，250014，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.07.014']
1787,32768555,Association Between Pretreatment Sleep Disturbance and Radiation Therapy-Induced Pain in 573 Women With Breast Cancer.,"CONTEXT


Pain can be a debilitating side effect of radiation therapy (RT). Data from the general population have shown that sleep disturbance can influence pain incidence and severity; however, less is known about this relationship in patients with breast cancer receiving RT.
OBJECTIVES


This secondary analysis examined the association of pretreatment moderate/severe levels of sleep disturbance with subsequent RT-induced pain after adjusting for pre-RT pain.
METHODS


We report on 573 female patients with breast cancer undergoing RT from a previously completed Phase II clinical trial for radiation dermatitis. Sleep disturbance, total pain, and pain subdomains-sensory pain, affective pain, and perceived pain intensity were assessed at pre-RT and post-RT. At pre-RT, patients were dichotomized into two groups: those with moderate/severe sleep disturbance (N = 85) vs. those with no/mild sleep disturbance (control; N = 488).
RESULTS


At pre-RT, women with moderate/severe sleep disturbance were younger, less likely to be married, more likely to have had mastectomy and chemotherapy, and more likely to have depression/anxiety disorder and fatigue than the control group (all Ps < 0.05). Generalized estimating equations model, after controlling for pre-RT pain and other covariates (e.g., trial treatment condition and covariates that were significantly correlated with post-RT pain), showed that women with moderate/severe sleep disturbance at pre-RT vs. control group had significantly higher mean post-RT total pain as well as sensory, affective, and perceived pain (effect size = 0.62, 0.60, 0.69, and 0.52, respectively; all Ps < 0.05).
CONCLUSION


These findings suggest that moderate/severe disturbed sleep before RT is associated with increased pain from pre-to-post-RT in patients with breast cancer.",2020,"This secondary analysis examined the association of pre-treatment moderate/severe levels of sleep disturbance with subsequent RT-induced pain after adjusting for pre-RT pain.
","['breast cancer patients receiving RT', 'breast cancer patients', '573 female breast cancer patients undergoing RT from a previously completed phase II clinical trial for radiation dermatitis', '573 women with breast cancer', 'N=85) vs. those with no/mild sleep disturbance (control; N=488']",['radiation therapy-induced pain'],"['severe sleep disturbance', 'sensory, affective, and perceived pain (effect', 'mean post-RT total pain', 'depression/anxiety disorder and fatigue', 'Sleep disturbance, total pain, and pain subdomains - sensory pain, affective pain, and perceived pain intensity', 'pain']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445177', 'cui_str': 'Post-radiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",573.0,0.0252795,"This secondary analysis examined the association of pre-treatment moderate/severe levels of sleep disturbance with subsequent RT-induced pain after adjusting for pre-RT pain.
","[{'ForeName': 'Anita R', 'Initials': 'AR', 'LastName': 'Peoples', 'Affiliation': 'Clinical and Translational Science Institute, University of Rochester Medical Center, Rochester, New York, USA. Electronic address: anita.peoples@hci.utah.edu.'}, {'ForeName': 'Wilfred R', 'Initials': 'WR', 'LastName': 'Pigeon', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, New York, USA; Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Clinical and Translational Science Institute, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Perlis', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Inglis', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vinciguerra', 'Affiliation': 'Northwell Health NCORP, Lake Success, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Columbus NCORP, Columbus, Ohio, USA.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Evans', 'Affiliation': 'Southeast Clinical Oncology Research Consortium NCORP, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Heartland Cancer Research NCORP, Decatur, Illinois, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Ossip', 'Affiliation': 'Clinical and Translational Science Institute, University of Rochester Medical Center, Rochester, New York, USA; Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, Rochester, New York, USA.'}, {'ForeName': 'Julie Ryan', 'Initials': 'JR', 'LastName': 'Wolf', 'Affiliation': 'Departments of Dermatology and Radiation Oncology, University of Rochester Medical Center, Rochester, New York, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.041']
1788,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND


Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS


We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS


A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
1789,32772383,Opioid and Dopamine Genes Interact to Predict Naltrexone Response in a Randomized Alcohol Use Disorder Clinical Trial.,"BACKGROUND


While the opiate antagonist, naltrexone, is approved for treating alcohol use disorder (AUD), not everyone who receives the medication benefits from it. This study evaluated whether the OPRM1 SNP rs1799971 interacts with the dopamine transporter gene DAT1/SLC6A3 VNTR rs28363170 or the catechol-O-methyltransferase (COMT) gene SNP rs4680 in predicting naltrexone response.
METHODS


Individuals who met DSM-IV alcohol dependence were randomly assigned to naltrexone (50 mg/d) or placebo based on their OPRM1 genotype (75 G-allele carriers and 77 A-allele homozygotes) and also genotyped for DAT1 VNTR (9 vs. 10 repeats) or COMT SNP (val/val vs. met carriers). Heavy drinking days (%HDD) were evaluated over 16 weeks and at the end of treatment. Effect sizes (d) for naltrexone response were calculated based on genotypes.
RESULTS


Naltrexone, relative to placebo, significantly reduced %HDD among OPRM1 G carriers who also had DAT1 10/10 (p = 0.021, d = 0.72) or COMT val/val genotypes (p = 0.05, d = 0.80), and to a lesser degree in those OPRM1 A homozygotes who were also DAT1 9-repeat carriers (p = 0.09, d = 0.70) or COMT met carriers (p = 0.03, d = 0.63). All other genotype combinations showed no differential response to naltrexone. Diarrhea/abdominal pain was more prominent in OPRM1 A homozygotes who were also DAT 9 or COMT met carriers.
CONCLUSIONS


These results suggest that individuals with AUD with a more opioid-responsive genotype (OPRM1 G carriers) respond better to naltrexone if they have genotypes indicating normal/less dopamine tone (DAT1 10,10 or COMT val,val), while those with a less responsive opioid-responsive genotype (OPRM1 A homozygotes) respond better to naltrexone if they have genotypes indicating greater dopamine tone (DAT1 9-repeat or COMT met carriers). These results could lead to more personalized AUD treatments.",2020,Diarrhea/abdominal pain was more prominent in OPRM1,"['Individuals with AUD with a more opioid-responsive genotype (OPRM1 G carriers', 'Individuals who met DSM-IV alcohol dependence']","['naltrexone', 'placebo based on their OPRM1 genotype', 'Opioid and Dopamine Genes', 'Naltrexone', 'COMT SNP', 'OPRM1', 'placebo']",['Diarrhea/abdominal pain'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",,0.0717863,Diarrhea/abdominal pain was more prominent in OPRM1,"[{'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Konstantin E', 'Initials': 'KE', 'LastName': 'Voronin', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Book', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Latham', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Patrick K', 'Initials': 'PK', 'LastName': 'Randall', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Willam Bailey', 'Initials': 'WB', 'LastName': 'Glen', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Schacht', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, Charleston, South Carolina, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14431']
1790,32772460,Informing American Muslims about living donation through tailored health education: A randomized controlled crossover trial evaluating increase in biomedical and religious knowledge.,"Biomedical and religious knowledge affects organ donation attitudes among Muslims. We tested the effectiveness of mosque-based, religiously tailored, ethically balanced education on organ donation among Muslim Americans. Our randomized, controlled, crossover trial took place at 4 mosques randomized to an early arm where organ donation education preceded a control educational workshop or a late arm with the order reversed. Primary outcomes were changes in biomedical (Rotterdam Renal Replacement Knowledge Test living donation subscale, R3KT) and religious (Islamic Knowledge of Living Organ Donation, IK-LOD) living kidney donation knowledge. Statistical analysis employed a 2 (Treatment Arm) X 3 (Time of Assessment) mixed-method analysis of variance. Of 158 participants, 59 were in the early arm and 99 in the late arm. A between group t test comparison at Period 1 (Time 1 - Time 2), demonstrated that the early arm had a significantly higher mean IK-LOD (7.11 v 5.19, P < .05) and R3KT scores (7.65 v 4.90, P < .05) when compared to the late arm. Late arm participants also had significant increases in mean IK-LOD (5.19 v 7.16, P < .05) and R3KT scores (4.90 v. 6.81, P < .05) postintervention (Time 2-Time 3). Our novel program thus yielded significant kidney donation-related knowledge gains among Muslim Americans (NCT04443114 Clinicaltrials.gov).",2020,Late arm participants also had significant increases in mean IK-LOD (,"['Muslim Americans', 'Of 158 participants, 59 were in the early arm and 99 in the late arm']","['mosque-based, religiously-tailored, ethically-balanced education', 'control educational workshop']","['mean IK-LOD', 'R3KT scores', 'mean IK-LOD ', 'changes in biomedical (Rotterdam Renal Replacement Knowledge living donation subscale, R3KT) and religious (Islamic Knowledge of Living Organ Donation, IK-LOD) living kidney donation knowledge']","[{'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0562614', 'cui_str': 'Mosque'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",158.0,0.0499988,Late arm participants also had significant increases in mean IK-LOD (,"[{'ForeName': 'Aasim I', 'Initials': 'AI', 'LastName': 'Padela', 'Affiliation': 'Initiative on Islam and Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Duivenbode', 'Affiliation': 'Initiative on Islam and Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quinn', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Milda R', 'Initials': 'MR', 'LastName': 'Saunders', 'Affiliation': 'MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16242']
1791,32771088,"Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study.","BACKGROUND


Poly (ADP-ribose) polymerase inhibitors combined with immunotherapy have shown antitumour activity in preclinical studies. We aimed to assess the safety and activity of olaparib in combination with the PD-L1-inhibitor, durvalumab, in patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer.
METHODS


The MEDIOLA trial is a multicentre, open-label, phase 1/2, basket trial of durvalumab and olaparib in solid tumours. Patients were enrolled into four initial cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer. Here, we report on the cohort of patients with breast cancer. Patients who were aged 18 years or older (or aged 19 years or older in South Korea) with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centres in the UK, the USA, Israel, France, Switzerland, and South Korea. Patients should not have received more than two previous lines of chemotherapy for metastatic breast cancer. Patients received 300 mg olaparib in tablet form orally twice daily for 4 weeks and thereafter a combination of olaparib 300 mg twice daily and durvalumab 1·5 g via intravenous infusion every 4 weeks until disease progression. Primary endpoints were safety and tolerability, and 12-week disease control rate. Safety was analysed in patients who received at least one dose of study treatment, and activity analyses were done in the full-analysis set (patients who received at least one dose of study treatment and were not excluded from the study). Recruitment has completed and the study is ongoing. This trial is registered with ClinicalTrials.gov, NCT02734004.
FINDINGS


Between June 14, 2016, and May 2, 2017, 34 patients were enrolled and received both study drugs and were included in the safety analysis. 11 (32%) patients experienced grade 3 or worse adverse events, of which the most common were anaemia (four [12%]), neutropenia (three [9%]), and pancreatitis (two [6%]). Three (9%) patients discontinued due to adverse events and four (12%) patients experienced a total of six serious adverse events. There were no treatment-related deaths. 24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
INTERPRETATION


Combination of olaparib and durvalumab showed promising antitumour activity and safety similar to that previously observed in olaparib and durvalumab monotherapy studies. Further research in a randomised setting is needed to determine predictors of therapeutic benefit and whether addition of durvalumab improves long-term clinical outcomes compared with olaparib monotherapy.
FUNDING


AstraZeneca.",2020,"24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
","['Patients who were aged 18 years or older (or aged 19 years or older in South Korea) with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centres in the UK, the USA, Israel, France, Switzerland, and South Korea', 'in solid tumours', 'Patients were enrolled into four initial cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer', 'patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer', 'Between June 14, 2016, and May 2, 2017, 34 patients were enrolled and received both study drugs and were included in the safety analysis', 'patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA', 'patients with breast cancer']","['olaparib', 'Olaparib and durvalumab', 'olaparib 300 mg twice daily and durvalumab 1·5 g via intravenous infusion', 'durvalumab and olaparib', 'durvalumab', 'chemotherapy']","['Safety', 'neutropenia', 'total of six serious adverse events', 'anaemia', 'grade 3 or worse adverse events', 'safety and tolerability, and 12-week disease control rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4721779', 'cui_str': 'Ovarian cancer stage IV'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",34.0,0.187663,"24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: susan.domchek@pennmedicine.upenn.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Postel-Vinay', 'Affiliation': 'ATIP -Avenir group, Inserm Unit U981, Villejuif, France; Faculté de Médicine, Le Kremlin Bicêtre, Université Paris Saclay, Université Paris-Sud, Villejuif, France; Department of Drug Development, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of South Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of South Korea.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse, Toulouse, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Hôpital Cochin, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'You', 'Affiliation': ""Medical Oncology, Institut de Cancérologie des Hospices Civils de Lyon, Centre d'Investigation de Therapeutiques en Oncologie et H ematologie de Lyon, Centre Hospitalier Lyon-Sud, Lyon, France; Faculté de Médecine Lyon-Sud, Univ Lyon, Université Claude Bernard Lyon 1, EMR UCBL/HCL 3738, Lyon, France; Groupe des Investigateurs Nationaux pour les Cancers de l Ovaire et du sein-GINEGEPS, Paris, France.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bastian', 'Affiliation': 'Kantonsspital Graubuenden, Chur, Switzerland.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Krebs', 'Affiliation': 'Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK; Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Henry Ford Medical Center, Detroit, MI, USA.'}, {'ForeName': 'Saiama N', 'Initials': 'SN', 'LastName': 'Waqar', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lanasa', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Rhee', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Vidalba', 'Initials': 'V', 'LastName': 'Rocher-Ros', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Jones', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sakshi', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coenen-Stass', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Iwanka', 'Initials': 'I', 'LastName': 'Kozarewa', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Zhongwu', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Angell', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Opincar', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Herbolsheimer', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Kaufman', 'Affiliation': 'Chaim Sheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30324-7']
1792,32779096,"IncobotulinumtoxinA for the Treatment of Blepharospasm in Toxin-Naïve Subjects: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial.","This study aimed to assess the efficacy/safety of incobotulinumtoxinA (Xeomin ® , Merz Pharmaceuticals GmbH) in botulinum neurotoxin-naïve subjects with blepharospasm. Botulinum neurotoxin-naïve subjects (≥ 12 months without botulinum neurotoxin treatment for blepharospasm) received single-dose incobotulinumtoxinA 50 U, 25 U, or placebo. Subjects were followed for 6-20 weeks (main period). Qualified subjects entered an open-label extension period and received another incobotulinumtoxinA injection (≤ 70 U). The primary efficacy variable was change from baseline in the Jankovic Rating Scale (JRS) severity subscore at the main period of week 6. Other efficacy variables included changes in the Blepharospasm Disability Index score and JRS frequency subscore and sumscore. Adverse events were monitored. Sixty-one subjects were randomized (main period: incobotulinumtoxinA 50 U, n = 19; incobotulinumtoxinA 25 U, n = 22; placebo, n = 20); 39 entered the open-label extension period (9, 14, and 16 subjects from the incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo groups [main period], respectively, changed to open-label extension period dosing). A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004). Subjects receiving incobotulinumtoxinA experienced improvements in other efficacy variables versus baseline and/or placebo. Sustained clinical improvements and low adverse event rates (22.2-42.1%) were observed. This is the second placebo-controlled, double-blind study that demonstrates favorable efficacy/safety of incobotulinumtoxinA in subjects with blepharospasm. IncobotulinumtoxinA is the first botulinum neurotoxin that could fulfill the American Academy of Neurology criteria for a Level A recommendation for blepharospasm.Trial registration ClinicalTrials.gov identifier, NCT01896895.",2020,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","['botulinum neurotoxin-naïve subjects with blepharospasm', 'Sixty-one subjects were randomized (main period', 'subjects with blepharospasm']","['IncobotulinumtoxinA', 'Placebo', 'incobotulinumtoxinA 50 U, n\u2009=\u200919; incobotulinumtoxinA 25 U, n\u2009=\u200922; placebo, n\u2009=\u200920', 'Botulinum neurotoxin-naïve subjects (≥\u200912\xa0months without botulinum neurotoxin', 'incobotulinumtoxinA', 'incobotulinumtoxinA injection', 'single-dose incobotulinumtoxinA 50 U, 25\xa0U, or placebo', 'incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo', 'placebo']","['low adverse event rates', 'Adverse events', 'Blepharospasm Disability Index score and JRS frequency subscore and sumscore', 'Jankovic Rating Scale (JRS) severity subscore', 'JRS severity subscore']","[{'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",61.0,0.42825,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","[{'ForeName': 'Dimos D', 'Initials': 'DD', 'LastName': 'Mitsikostas', 'Affiliation': '1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece. dimosmitsikostas@icloud.com.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Sternberg', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Department of Neurology, Georgetown University Hospital Pasquerilla Healthcare Center, Washington, DC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01427-6']
1793,32780476,Effects of interphase interval during neuromuscular electrical stimulation of the wrist extensors with maximally tolerated current intensity.,"Short interphase intervals (IPIs) within biphasic symmetrical pulses enhance maximal electrically induced isometric contractions (EIC). However, IPI effects have not been previously studied in muscles stimulated at the highest tolerated current intensity. Our aim was to examine IPI effects on the strength of EIC, degree of discomfort, and sensory and motor thresholds on the wrist extensor muscles. Eighteen subjects (mean age 25.5, SD ± 3.97 years) participated in a repeated-measures trial. Five parameter settings were used to stimulate the wrist extensors: monophasic pulses with phase durations (PD) 200 µs, and biphasic pulses with PDs either 200 or 500 µs, applied with/without an IPI of 200 µs duration. Order of settings was randomized, and current was set at the maximum intensity tolerated by each subject. IPIs applied at the maximally tolerated current intensity did not increase the strength of the EICs and did not reduce the degree of discomfort or the sensory and motor thresholds. These findings were not dependent on the PDs. Insertion of an IPI within the biphasic current during stimulation of the wrist muscle yielded no advantage in term of contraction strength or degree of discomfort. These results contradict previous studies indicating stronger contractions when an IPI is inserted during stimulation at a predetermined submaximal current intensity. As some of the clinical applications of neuromuscular electrical stimulation utilize the highest intensity tolerated by the individual, these findings are clinically relevant. Additional studies involving other muscle groups, electrode size and locations, and phase parameters are warranted.",2020,"RESULTS


IPIs applied at the maximally tolerated current intensity did not increase the strength of the EICs and did not reduce the degree of discomfort or the sensory and motor thresholds.","['Eighteen subjects (mean age 25.5, SD±3.97 years) participated in a repeated-measures trial']","['wrist extensors: monophasic pulses with phase durations (PD) 200µs, and biphasic pulses with PDs either 200µs or 500 µs, applied with/without an IPI of 200µs duration']","['strength of EIC, degree of discomfort, and sensory and motor thresholds', 'degree of discomfort or the sensory and motor thresholds', 'strength of the EICs', 'isometric contractions (EIC']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",5.0,0.0342559,"RESULTS


IPIs applied at the maximally tolerated current intensity did not increase the strength of the EICs and did not reduce the degree of discomfort or the sensory and motor thresholds.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Elboim-Gabyzon', 'Affiliation': 'Department of Physical Therapy, Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Awad', 'Affiliation': 'Department of Physical Therapy, Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, Israel.'}]",Artificial organs,['10.1111/aor.13794']
1794,32776202,Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO ® /DYNAGITO ®  Trials.,"INTRODUCTION


Previous studies demonstrated that tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population.
METHODS


This post hoc analysis pooled data from TONADO ®  1 + 2 and DYNAGITO ® , three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received tiotropium/olodaterol 5/5 µg or tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use.
RESULTS


In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium. Lower rates of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with tiotropium/olodaterol versus tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium in patients receiving ICS.
CONCLUSIONS


Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice.
TRIAL REGISTRATION


TONADO ®  1 (ClinicalTrials.gov: NCT01431274); TONADO ®  2 (ClinicalTrials.gov: NCT01431287); DYNAGITO ®  (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO ®  1 + 2 and DYNAGITO ® ) that looked at people who were taking tiotropium and olodaterol together and people who were taking tiotropium alone. We showed that, across a wide range of people, treatment with tiotropium/olodaterol was generally better at reducing exacerbations than tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with tiotropium. Overall, our results support the use of combined tiotropium/olodaterol in people at different stages of COPD.",2020,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","['patients with moderate-to-very severe COPD, with and without previous exacerbations, who received', 'patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD', 'People with chronic obstructive pulmonary disease (COPD']","['tiotropium/olodaterol versus tiotropium; GOLD', 'tiotropium/olodaterol 5/5\xa0µg or tiotropium 5\xa0µg', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'Tiotropium/olodaterol', 'inhaled medicine-tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['number of exacerbations', 'severe exacerbation rates', 'rate of moderate/severe exacerbations', 'Lower rates of moderate/severe exacerbations', 'Exacerbation Rates', 'exacerbations requiring hospitalisation', 'rates of moderate/severe exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",9942.0,0.709479,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","[{'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK. j.wedzicha@imperial.ac.uk.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anzueto', 'Affiliation': 'Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",Advances in therapy,['10.1007/s12325-020-01438-3']
1795,32777289,"Fixed-dose combination of three drugs, i.e. LABA/LAMA/ICS for COPD: Results of a real-world study from India.","BACKGROUND


The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD.
PATIENTS AND METHODS


In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in 1 s (FEV 1 ) at week 24. Pre and post-dose (30 min) FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety were also evaluated. A post-hoc analysis was conducted to evaluate the efficacy of the triple drug combination among smoker and non-smoker COPD patients.
RESULTS


Out of the 297 patients enrolled [mean age 61 ± 10 years; 84.8% males; 55.2% smokers and post-dose FEV 1  (% predicted) 39 ± 16%], 253 completed the study. Mean change in pre-dose FEV 1  from baseline to week 24 increased significantly after administering the triple drug combination [580 ± 600 mL, 95% CI (510, 650 mL), p < 0.0001]. The increase in the pre-dose FEV 1  was significant at all time points (p < 0.0001). Similar improvements were seen in pre-dose FVC, post-dose FEV 1  and post-dose FVC across all time points. CAT scores and the proportion of patients with improved mMRC score improved at all visits. The post-hoc analysis showed that TFC significantly increased pre-dose FEV 1  both among smokers [mean change 200 ± 430 mL, 95% CI (130, 270 mL), p < 0.0001] as well as non-smokers [990 ± 470 mL, 95% CI (900, 1070 mL), p < 0.0001] at week 24. This difference was significant from week 12 onwards. Mean change in pre and post-dose FEV 1  and FVC was significant across all visits between the two groups. At week 24, CAT score reduced significantly from baseline (overall: -6.6 ± 6.07; smokers: -5.17 + 6.96; non-smokers: 8.06 ± 4.44; all p < 0.0001). The mean difference between the two groups was 2.88 (p < 0.0001) at week 24. TFC was well tolerated.
CONCLUSION


In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.",2020,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"['COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations', 'patients with COPD', 'smoker and non-smoker COPD patients', 'COPD patients requiring triple therapy as judged by their physician, were enrolled', '297 patients enrolled [mean age 61±10 years; 84.8% males; 55.2% smokers and post-dose']","['LABA/LAMA/ICS', 'TFC', 'Tiotropium/Formoterol/Ciclesonide (TFC']","['CAT score', 'tolerated', 'mMRC score', 'FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety', 'lung function, symptoms and quality of life', 'mean change from baseline in pre-dose Forced Expiratory Volume', 'CAT scores']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}]","[{'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",297.0,0.141329,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"[{'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Salvi', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Deb', 'Affiliation': 'Sudbhavana Hospital, Varanasi, India.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Om Surgical Center & Maternity Home, Varanasi, India.'}, {'ForeName': 'Venkateswara Reddy', 'Initials': 'VR', 'LastName': 'Tummuru', 'Affiliation': 'Eesha Multispeciality Hospital, Hyderabad, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kodgule', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Hemalatha', 'Affiliation': 'Sree Narayana Institute of Medical Sciences, Ernakulam, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Awasthi', 'Affiliation': 'Ajantha Hospitals & IVF Centre Pvt. Ltd., Lucknow, India.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Suraj', 'Affiliation': 'Institute of Chest Diseases, Kozhikode, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Pavitran', 'Affiliation': 'KVM Multispeciality Hospital, Chirtihala, India.'}, {'ForeName': 'Shashi Prakash', 'Initials': 'SP', 'LastName': 'Mourya', 'Affiliation': 'Lal Hospital & Heart Centre, Lucknow, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Madonna Hospital and Research Centre, Ernakulam, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}, {'ForeName': 'Sushmeeta', 'Initials': 'S', 'LastName': 'Chhowala', 'Affiliation': 'Cipla Ltd, Mumbai, India. Electronic address: sushmeeta@cipla.com.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Gogtay', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101932']
1796,32777381,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino emergency department patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building, Rooms 102 and 104, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106104']
1797,32773226,Effect of Ezetimibe + Pitavastatin on Cardiovascular Outcomes in Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study).,"Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate the effect of intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe, on patients with STEMI. We therefore undertook a post hoc subanalysis of the HIJ-PROPER study's data that examined the clinical outcomes of the patients with dyslipidemia and STEMI (n = 880) who received pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group), and we evaluated their cardiovascular events. The primary end point was a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization. During the median 3.4-year follow-up period, the cumulative rates of the primary end point were 31.9% and 39.7% in the intensive lipid-lowering therapy and standard lipid-lowering therapy groups, respectively (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62 to 0.97; p = 0.02). Compared with the standard lipid-lowering therapy group, the intensive lipid-lowering therapy group had significantly lower all-cause death (6.9% vs 3.2%; HR, 0.45; 95% CI, 0.23 to 1.84; p = 0.01) and nonfatal stroke (2.9% vs 1.6%; HR, 0.77; 95% CI, 0.62 to 0.97; p = 0.02) rates. Patients with pitavastatin and ezetimibe therapy, as compared with pitavastatin monotherapy, had a lower cardiovascular event in STEMI patients. In conclusion, adding ezetimibe to statin therapy may be beneficial for patients with dyslipidemia and STEMI.",2020,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"['Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study', 'patients with dyslipidemia and STEMI', 'patients with dyslipidemia and STEMI (n\u202f=\u202f880) who received', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI']","['intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe', 'Lipid-lowering therapy', 'pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group', 'ezetimibe', 'pitavastatin and ezetimibe therapy', 'Ezetimibe\u202f+\u202fPitavastatin', 'pitavastatin monotherapy', 'standard lipid-lowering therapy']","['cumulative rates', 'cause death', 'cardiovascular event rates', 'nonfatal stroke', 'Cardiovascular Outcomes', 'composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",880.0,0.0372168,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"[{'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: j.yamaguchi0110@gmail.com.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}]",The American journal of cardiology,['10.1016/j.amjcard.2020.06.069']
1798,32574418,Role of Terlipressin and Albumin for Hepatorenal Syndrome in Liver Transplantation.,"Hepatorenal syndrome (HRS) is one of the most ominous complications of portal hypertension in patients with decompensated cirrhosis and ascites. It is associated with very high mortality on the wait list. Liver transplantation (LT) is the most successful therapeutic option for patients with HRS. However, not all the LT candidates with HRS are able to receive a deceased donor allograft in a timely manner because it is a scarce resource and patients may need alternative best supportive treatment with systemic splanchnic vasoconstrictors and albumin as a bridge to transplant. The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide. More recently, the multicenter, randomized, placebo-controlled double-blind study to confirm efficacy and safety of terlipressin in subjects with hepatorenal syndrome type 1 (the CONFIRM study) trial demonstrated the efficacy of terlipressin and albumin in the reversal of HRS in a North American cohort. The aim of this article is to review the role of terlipressin and albumin in LT candidates with HRS in the United States.",2020,The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide.,"['Hepatorenal Syndrome in Liver Transplantation', 'subjects with hepatorenal syndrome type 1', 'patients with decompensated cirrhosis and ascites', 'patients with HRS']","['Liver transplantation (LT', 'terlipressin and albumin', 'terlipressin', 'Terlipressin and Albumin', 'placebo']",['Hepatorenal syndrome (HRS'],"[{'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}]",,0.0877855,The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide.,"[{'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'University College London Institute for Liver and Digestive Health, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ganger', 'Affiliation': 'Division of Gastroenterology and Hepatology, Northwestern Medicine, Chicago, IL.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Grewal', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mount Sinai Health System, New York, NY.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Brown', 'Affiliation': 'Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25834']
1799,32782626,"Effectiveness of a resistance training program on physical function, muscle strength, and body composition in community-dwelling older adults receiving home care: a cluster-randomized controlled trial.","Background


Aging is associated with reduced muscle mass and strength leading to impaired physical function. Resistance training programs incorporated into older adults' real-life settings may have the potential to counteract these changes. We evaluated the effectiveness of 8 months resistance training using easily available, low cost equipment compared to physical activity counselling on physical function, muscle strength, and body composition in community-dwelling older adults receiving home care.
Methods


This open label, two-armed, parallel group, cluster randomized trial recruited older adults above 70 years (median age 86.0 (Interquartile range 80-90) years) receiving home care. Participants were randomized at cluster level to the resistance training group (RTG) or the control group (CG). The RTG trained twice a week while the CG were informed about the national recommendations for physical activity and received a motivational talk every 6th week. Outcomes were assessed at participant level at baseline, after four, and 8 months and included tests of physical function (chair rise, 8 ft-up-and-go, preferred- and maximal gait speed, and stair climb), maximal strength, rate of force development, and body composition.
Results


Twelve clusters were allocated to RTG (7 clusters, 60 participants) or CG (5 clusters, 44 participants). The number of participants analyzed was 56-64 (6-7 clusters) in RTG and 20-42 (5 clusters) in CG. After 8 months, multilevel linear mixed models showed that RTG improved in all tests of physical function and maximal leg strength (9-24%,  p  = 0.01-0.03) compared to CG. No effects were seen for rate of force development or body composition.
Conclusion


This study show that resistance training using easily available, low cost equipment is more effective than physical activity counselling for improving physical function and maximal strength in community-dwelling older adults receiving home care.
Trial registration


ISRCTN1067873.",2020,"After 8 months, multilevel linear mixed models showed that RTG improved in all tests of physical function and maximal leg strength (9-24%,  p  = 0.01-0.03) compared to CG.","['community-dwelling older adults receiving home care', 'older adults above 70\u2009years (median age 86.0 (Interquartile range 80-90) years) receiving home care']","['resistance training program', 'Resistance training programs', 'RTG', 'CG', 'physical activity counselling', 'resistance training group (RTG) or the control group (CG']","['rate of force development or body composition', 'physical function, muscle strength, and body composition', 'physical function and maximal leg strength', 'physical function (chair rise, 8\u2009ft-up-and-go, preferred- and maximal gait speed, and stair climb), maximal strength, rate of force development, and body composition']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}]",12.0,0.0389963,"After 8 months, multilevel linear mixed models showed that RTG improved in all tests of physical function and maximal leg strength (9-24%,  p  = 0.01-0.03) compared to CG.","[{'ForeName': 'Hilde Bremseth', 'Initials': 'HB', 'LastName': 'Bårdstu', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}, {'ForeName': 'Marius Steiro', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Aasdahl', 'Affiliation': 'Unicare Helsefort Rehabilitation Centre, Rissa, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Kristoffer T', 'Initials': 'KT', 'LastName': 'Cumming', 'Affiliation': 'Department of Sports, Physical Education and Outdoor Studies, Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Vestfold, Norway.'}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Sæterbakken', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}]",European review of aging and physical activity : official journal of the European Group for Research into Elderly and Physical Activity,['10.1186/s11556-020-00243-9']
1800,31879857,Associations of Changes in Organizational Justice with Job Attitudes and Health-Findings from a Prospective Study Using a Matching-Based Difference-in-Difference Approach.,"BACKGROUND


Ample evidence indicates that unfairness at the workplace (organizational injustice) is associated with both job attitudes and health of employees. Several factors that influence these associations have been identified: e.g., personality traits, such as the Big Five traits, justice sensitivity, type of occupation (e.g., white-collar), and unobserved time-invariant factors. Previous studies only addressed parts of these issues, and the ideal research design to mitigate biases-an experiment with random assignment to a treatment and control group-is not feasible. This study therefore mimics a randomized experiment using two statistical techniques.
METHODS


First, matching was implemented to balance the treatment and control group in confounding factors (demographics and personality) in two prospective waves (2012-2014) of observational data (4522 white-collar, 2984 blue-collar) taken from the Linked Personnel Panel, which is an employee survey representative for German private sector companies with more than 50 employees. Second, a difference-in-difference approach excludes unobserved time-invariant factors by estimating associations of changes in organizational justice (distributive, procedural, interactional) with job attitudes (job satisfaction, turnover intention) and health (general and mental) in these groups, separate for white- and blue-collar employees.
RESULTS


A decrease in perceived justice was associated with lower job attitudes (less job satisfaction and higher turnover intentions), while an increase was associated with higher values. This pattern was found for white- and blue-collar workers and also for health indicators, with the latter, however, being less pronounced.
CONCLUSIONS


Increased fairness at the workplace is related to better job attitudes and health for white- and blue-collar employees, independent of personality traits and unobserved time-invariant factors.",2020,"CONCLUSIONS


Increased fairness at the workplace is related to better job attitudes and health for white- and blue-collar employees, independent of personality traits and unobserved time-invariant factors.","['two prospective waves (2012-2014) of observational data (4522 white-collar, 2984 blue-collar) taken from the Linked Personnel Panel, which is an employee survey representative for German private sector companies with more than 50 employees']",[],"['perceived justice', 'job satisfaction and higher turnover intentions', 'organizational justice (distributive, procedural, interactional) with job attitudes (job satisfaction, turnover intention) and health (general and mental', 'lower job attitudes']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0033176', 'cui_str': 'Private Sector'}, {'cui': 'C0439093', 'cui_str': '>'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0185265,"CONCLUSIONS


Increased fairness at the workplace is related to better job attitudes and health for white- and blue-collar employees, independent of personality traits and unobserved time-invariant factors.","[{'ForeName': 'Raphael M', 'Initials': 'RM', 'LastName': 'Herr', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. raphael.herr@medma.uni-heidelberg.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Almer', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Catherin', 'Initials': 'C', 'LastName': 'Bosle', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Fischer', 'Affiliation': 'Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09841-z']
1801,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
1802,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
1803,32798588,Anti-erosive effect of rinsing before or after toothbrushing with a Fluoride/Stannous Ions solution: an in situ investigation: Application order of Fluoride/Tin products for erosive tooth wear.,"OBJECTIVE


To evaluate the impact of the application of a F - /Sn 2+ -containing mouthrinse before or after toothbrushing with a F - /Sn 2+ /chitosan toothpaste on the progression of erosion/abrasion on enamel and dentin.
METHODS


This crossover in situ study had five arms: Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing + Rinsing, Rinsing + Brushing, and Rinsing (without toothbrushing). Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to erosion-abrasion cycling of 60 min salivary pellicle formation followed by 5 min extra-oral erosion with 1% citric acid (4x/day for 5 days). Treatments were performed in situ after first and last erosive challenges with rinse (10 ml; 30 s) and/or toothbrushing with/without toothpaste (with electric toothbrush; 5 s per specimen; total 2 min contact with slurry). Surface loss (SL) was evaluated with an optical profilometer. Data were analyzed by two-way repeated measures ANOVA and Tukey tests (α = 0.05).
RESULTS


The Control showed the highest SL (mean ± SD for enamel: 24.58 ± 11.32; dentin: 32.32 ± 10.10; all μm). Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing. None of the arms that underwent toothbrushing with the toothpaste differed from each other (p > 0.05). Dentin specimens showed significantly higher SL values than enamel (p < 0.001).
CONCLUSION


The order of treatment applications had no influence on their anti-erosive effect; however, toothbrushing with F - /Sn 2+ /chitosan toothpaste reduced enamel surface loss. Additional rinsing with F - /Sn 2+  mouthrinse did not offer improved protection.
CLINICAL SIGNIFICANCE


The use of fluoride- and stannous- containing toothpastes and mouthrinses is an important approach in the prevention of erosive tooth wear. Further evidence is needed to support the benefit of combining these products against this condition.",2020,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","['Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to']","['Rinsing', 'erosion-abrasion cycling of 60\u2009min salivary pellicle formation followed by 5\u2009min extra-oral erosion with 1% citric acid', 'fluoride- and stannous- containing toothpastes and mouthrinses', 'Fluoride/stannous Ions Solution', 'F-/Sn2+/chitosan toothpaste', 'F-/Sn2+ mouthrinse', 'Fluoride/Tin products', 'Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing\u2009+\u2009Rinsing, Rinsing\u2009+\u2009Brushing, and Rinsing (without toothbrushing', 'toothbrushing with/without toothpaste (with electric toothbrush; 5\u2009s per specimen; total 2\u2009min contact with slurry', 'F-/Sn2+-containing mouthrinse']","['Surface loss (SL', 'progression of erosion/abrasion on enamel and dentin', 'protection', 'enamel surface loss', 'SL values', 'SL value']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0225144,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: alanam@usp.br.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Sakae', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: leticia.sakae@usp.br.'}, {'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: thiago.saads@zmk.univbe.ch.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, University of Texas Health Science Center of San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: tais.sca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103450']
1804,32799709,"Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial.","Background High-density lipoprotein (HDL) cholesterol has inverse association with cardiovascular disease. HDL possesses anti-inflammatory properties in vitro, but it is unknown whether this may be protective in individuals with inflammation. Methods and Results The functional capacity of HDL to inhibit oxidation of oxidized low-density lipoprotein (ie, the HDL inflammatory index; HII) was measured at baseline and 12 months after random allocation to rosuvastatin or placebo in a nested case-control study of the JUPITER (Justification for the Use of Statins in Prevention: An Intervention Evaluating Rosuvastatin) trial. There were 517 incident cases of cardiovascular disease and all-cause mortality compared to 517 age- and sex-matched controls. Multivariable conditional logistic regression was used to examine associations of HII with events. Median baseline HII was 0.54 (interquartile range, 0.50-0.59). Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference). HII had a nonlinear relationship with incident events. Compared with the reference group (HII 0.5-1.0) with the lowest event rates, participants with baseline HII ≤0.5 had significantly increased risk of cardiovascular disease/mortality (adjusted hazard ratio, 1.53; 95% CI, 1.06-2.21;  P =0.02). Furthermore, there was significant ( P =0.002) interaction for HDL particle number with HII, such that having more HDL particles was associated with decreased risk only when HDL was anti-inflammatory. Conclusions In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0. This nonlinear relationship of anti-inflammatory HDL function with risk may account in part for the HDL paradox. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00239681.",2020,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference).","['individuals with inflammation', 'In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0']","['rosuvastatin', 'rosuvastatin or placebo', 'Registration URL', ' High-density lipoprotein (HDL) cholesterol', 'placebo']","['risk of cardiovascular disease/mortality', 'Median baseline HII', 'Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality', 'cardiovascular disease and all-cause mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242754', 'cui_str': 'Jupiter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",517.0,0.234502,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference).","[{'ForeName': 'Oluremi N', 'Initials': 'ON', 'LastName': 'Ajala', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Zareen', 'Initials': 'Z', 'LastName': 'Farukhi', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Adelman', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Collins', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Rader', 'Affiliation': 'Department of Genetics University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.016507']
1805,32800653,Study of the gastrointestinal bioavailability of a pancreatic extract product (Zenpep) in chronic pancreatitis patients with exocrine pancreatic insufficiency.,"INTRODUCTION


The Food and Drug Administration in 2006 required that all pancreatic enzyme products demonstrate bioavailability of lipase, amylase, and protease in the proximal small intestine.
METHODS


In this phase I open-label, randomized, crossover trial, 17 adult chronic pancreatitis (CP) patients with severe exocrine pancreatic insufficiency (EPI) underwent two separate gastroduodenal perfusion procedures (Dreiling tube suctioning and [ 14 C]-PEG instillation by an attached Dobhoff tube in the duodenal bulb). Patients received Ensure Plus® alone and Ensure Plus with Zenpep (75,000 USP lipase units) in random order. The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions.  14 C-PEG was used to correct duodenal aspirates volume. The primary efficacy endpoint was lipase delivery in the duodenum after Zenpep administration under fed conditions. Secondary efficacy endpoints included chymotrypsin and amylase delivery, serum CCK levels, and measuring duodenal and gastric pH.
RESULTS


Zenpep administration with a test meal was associated with significant increase in duodenal aspiration of lipase (p = 0.046), chymotrypsin (p = 0.008), and amylase (p = 0.001), compared to the test meal alone, indicating release of enzymes to the duodenum. Lipase delivery was higher in the pH subpopulation (the efficacy population with acid hypersecretors excluded) (p = 0.01). Recovery of [ 14 C]-PEG was 61%. Zenpep was generally well tolerated. All adverse events were mild and transient.
CONCLUSIONS


In CP patients with severe EPI, lipase, chymotrypsin and amylase were released rapidly into the duodenum after ingestion of Zenpep plus meal compared to meals alone. Results also reflected the known pH threshold for enzyme release from enteric coated products.",2020,"The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions.  ","['chronic pancreatitis patients with exocrine pancreatic insufficiency', '17 adult chronic pancreatitis (CP) patients with severe exocrine pancreatic insufficiency (EPI) underwent two']","['separate gastroduodenal perfusion procedures (Dreiling tube suctioning and [ 14 C]-PEG instillation by an attached Dobhoff tube in the duodenal bulb', 'pancreatic extract product (Zenpep', 'Plus® alone and Ensure Plus with Zenpep (75,000 USP lipase units']","['tolerated', 'bioavailability of lipase, amylase, and protease in the proximal small intestine', 'bioavailability of Zenpep', 'chymotrypsin and amylase delivery, serum CCK levels, and measuring duodenal and gastric pH', 'lipase delivery in the duodenum', 'recovery of lipase, amylase, chymotrypsin activity', 'Lipase delivery', 'duodenal aspiration of lipase']","[{'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0302945', 'cui_str': 'Carbon-14'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C3204189', 'cui_str': 'Nasoduodenal feeding tube'}, {'cui': 'C0227300', 'cui_str': 'Duodenal ampulla structure'}, {'cui': 'C0030289', 'cui_str': 'Pancreatic Extract'}, {'cui': 'C2725181', 'cui_str': 'Zenpep'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0059375', 'cui_str': 'Ensure Plus'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C2725181', 'cui_str': 'Zenpep'}, {'cui': 'C0008742', 'cui_str': 'CHYMOTRYPSIN'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]",17.0,0.0186206,"The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions.  ","[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Lieb', 'Affiliation': 'Section of Gastroenterology, University of Florida, 1549 Gale Lemerand Drive, Gainesville, FL, 32610-3008, USA. Electronic address: John.Lieb@medicine.ufl.edu.'}, {'ForeName': 'Dhruvan', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Section of Gastroenterology, University of Pennsylvania, 3400 Civic Center Blvd, 7th Floor, Philadelphia, PA, 19104, USA. Electronic address: pateldhruvan@gmail.com.'}, {'ForeName': 'Nihaal', 'Initials': 'N', 'LastName': 'Karnik', 'Affiliation': 'Department of Internal Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA. Electronic address: npkarnik@gmail.com.'}, {'ForeName': 'Phillip P', 'Initials': 'PP', 'LastName': 'Toskes', 'Affiliation': 'Section of Gastroenterology, University of Florida, 1549 Gale Lemerand Drive, Gainesville, FL, 32610-3008, USA. Electronic address: Phillip.toskes@medicine.ufl.edu.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.07.007']
1806,32802319,Effect of rehabilitation training on an elderly population with mild to moderate hearing loss: study protocol for a randomised clinical trial.,"Background:  Age-related hearing loss (presbycusis) is a form of hearing loss in over 60-year-olds and has a negative impact on quality of life. The pathophysiology of presbycusis is multifactorial and is predominately characterised with a loss of speech perception in noise. In the cochlea, auditory filters decompose broadband sound into a series of narrowband output signals, which contains two kinds of temporal information: slow changes in overall amplitude envelope (ENV) and faster variations in temporal fine structure (TFS). TFS is important for recognition of target speech in noise. The main aim of the study is to evaluate the effect of TFS rehabilitation training in participants over the age of 60 years with mild to moderate hearing loss.  Methods:  A randomised clinical trial  conduct on 30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old. Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease were excluded. Participants were randomly selected to an intervention and control group with a 1:1 ratio. Rehabilitation for the intervention Group are 30-minute sessions three times a week for a total five weeks of vowel consonant vowel words that are used to eliminate ENV and keep only TFS. Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores are performed at the beginning and end of study to evaluate the effect of rehabilitation training.  Conclusion:   Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis. A literature review highlighted that TFS damage is permanent; however, in this study we will attempt to prove that TFS training may lead to speech in noise perception restored.  Trial registration:  Registry of Clinical Trials, IRCT2019625044006N1 (7  th  August 2019).",2020,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","['participants over the age of 60 years with mild to moderate hearing loss', '30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old', 'elderly population with mild to moderate hearing loss', 'Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease']","['rehabilitation training', 'TFS training', 'TFS rehabilitation training', 'TFS']","['Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores', 'Life expectancy']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1852284', 'cui_str': 'Mild to moderate hearing loss'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",30.0,0.067655,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rasouli Fard', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Jarollahi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Seyyed Jalal', 'Initials': 'SJ', 'LastName': 'Sameni', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}]",F1000Research,['10.12688/f1000research.23332.2']
1807,32806525,Face-to-Face Exercises Performed by Instructors to Improve the Mental Health of Japanese in the Community-A Randomized Control Trial.,"Background and objectives:  The purpose of this study is to clarify the effects on the mental health of face-to-face exercise performed by an instructor (lesson-style Group: Group L) and exercise using machines (program-style Group: Group P) by randomized control trial.  Materials and Methods:  Among 120 subjects, 117 subjects were allocated to two groups with stratified randomization by sex (Group P: 58 subjects; Group L: 59 subjects). A 60-min health exercise class was held once per week for 12 consecutive weeks. The measurement items were mental health as a primary evaluation item and self-efficacy as a secondary evaluation item. Physical fitness was also measured using a new physical fitness test used in Japan. The 12-item general health questionnaire (GHQ-12) was used to measure mental health and the general self-efficacy scale (GSES) was used to measure self-efficacy.  Results:  After the intervention, 102 subjects were analyzed. The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L -0.7 (95% CI, -1.2 to -0.3) than Group P -0.1 (95% CI, -0.4 to 0.2) ( p  = 0.03). The changes in self-efficacy evaluated by GSES scores were significantly higher in Group P 5.3 (95% CI, 3.1 to 7.5) than Group L 1.3 (95% CI, -0.4 to 3.1) ( p  < 0.01).  Conclusions:  Compared with program exercises mainly using machines, face-to-face exercises performed by instructors improved mental health.",2020,"The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L -0.7 (95% CI, -1.2 to -0.3) than Group P -0.1 (95% CI, -0.4 to 0.2) ( p  = 0.03).","['102 subjects were analyzed', '120 subjects', '117 subjects']",['instructor (lesson-style Group: Group L) and exercise using machines (program-style Group: Group P'],"['12-item general health questionnaire (GHQ-12', 'mental health evaluated by GHQ-12 scores', 'mental health', 'mental health and the general self-efficacy scale (GSES', 'Physical fitness', 'self-efficacy evaluated by GSES scores']","[{'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441849', 'cui_str': 'Group P'}]","[{'cui': 'C4274135', 'cui_str': '12 item General Health Questionnaire'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",117.0,0.0284453,"The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L -0.7 (95% CI, -1.2 to -0.3) than Group P -0.1 (95% CI, -0.4 to 0.2) ( p  = 0.03).","[{'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Katayama', 'Affiliation': 'Faculty of Sociology, Shikoku Gakuin University, Zentsuji-shi, Kagawa 765-8505, Japan.'}, {'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Kanda', 'Affiliation': 'Department of Public Health, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Hase', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyatake', 'Affiliation': 'Department of Hygiene, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56080404']
1808,32808936,Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP): Protocol for a Randomized Clinical Trial to Test a Video-Based Telehealth Intervention.,"BACKGROUND


Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
OBJECTIVE


The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention.
METHODS


We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children.
RESULTS


Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date.
CONCLUSIONS


If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/17877.",2020,"Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
","['Caregivers and young children living with T1D learn to fear hypoglycemia', 'Childhood Hypoglycemia in Parents (REDCHiP', 'caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention', '180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States', 'young children with type 1 diabetes mellitus (T1D', 'randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention']","['REDCHiP intervention', 'video-based telehealth intervention', 'Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies', 'REDCHiP']","['Emotional Distress', 'severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0492481,"Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
","[{'ForeName': 'Susana R', 'Initials': 'SR', 'LastName': 'Patton', 'Affiliation': ""Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McConville', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, KS, United States.'}, {'ForeName': 'Arwen M', 'Initials': 'AM', 'LastName': 'Marker', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, KS, United States.'}, {'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Monzon', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, KS, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Driscoll', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Clements', 'Affiliation': ""Children's Mercy Hospital-Kansas City, Kansas City, MO, United States.""}]",JMIR research protocols,['10.2196/17877']
1809,32809950,"Correction: A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial.",[This corrects the article DOI: 10.2196/17561.].,2020,[This corrects the article DOI: 10.2196/17561.].,['Parents of Children With Chronic Life-Threatening Illnesses'],"['Correction', 'Narrative E-Writing Intervention']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.066439,[This corrects the article DOI: 10.2196/17561.].,"[{'ForeName': 'Andy Hau Yan', 'Initials': 'AHY', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Oindrila', 'Initials': 'O', 'LastName': 'Dutta', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Tan-Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Toh Hsiang Benny', 'Initials': 'THB', 'LastName': 'Tan', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Xinyi Casuarine', 'Initials': 'XC', 'LastName': 'Low', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Sashikumar', 'Initials': 'S', 'LastName': 'Ganapathy', 'Affiliation': 'Club Rainbow, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Ringo Moon-Ho', 'Initials': 'RM', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Chun Yan', 'Initials': 'CY', 'LastName': 'Miao', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}]",JMIR research protocols,['10.2196/22286']
1810,32810147,"An intimate partner violence prevention intervention for men, women, and couples in Ethiopia: Additional findings on substance use and depressive symptoms from a cluster-randomized controlled trial.","BACKGROUND


Intimate partner violence (IPV) is linked to substance use by male perpetrators and is associated with an increased risk of depression for women who experience violence. Unite for a Better Life (UBL) is a gender-transformative intervention delivered to men, women, and couples in Ethiopia; previous evidence demonstrated the intervention significantly reduced experience of and perpetration of IPV when delivered to men and led to more equitable household task-sharing when delivered to men and couples. The aim of this analysis is to assess engagement in the UBL intervention and to examine the relationship between random assignment to the intervention and men's past-year substance use and women's reported depressive symptoms as measured at the individual level.
METHODS AND FINDINGS


A sample of 64 villages in Gurague zone, Ethiopia, was randomly allocated to 4 arms (men's UBL, women's UBL, couples' UBL, or control). In each village, 106 households were randomly sampled, and households in the intervention arms were invited to participate in UBL, consisting of 14 sessions delivered by trained facilitators. Households in the control arm were offered a short educational session on IPV. Descriptive data on participant engagement in the intervention are reported, and outcomes assessed in an intention-to-treat (ITT) analysis include male use of substances (alcohol and khat) and women's depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9). Results from both adjusted and unadjusted specifications are reported, the latter adjusting for baseline covariates including age, education level, marriage length, polygamy, socioeconomic status, months between intervention and endline, and the baseline level of the outcome variable. The baseline sample includes 6,770 respondents surveyed in 2014-2015, and follow-up data were available from 88% of baseline respondents surveyed in 2017-2018; the majority of respondents report no education, and 61% are Muslim. Respondents reported high attendance rates and engagement in the intervention. In addition, there was evidence of a significant reduction in frequent past-year alcohol intoxication self-reported by men (adjusted odds ratio [AOR] = 0.56, 95% CI 0.36-0.85, p = 0.007), and a significant increase in the probability of frequent khat use self-reported by men (AOR = 3.09, 95% CI 1.37-6.96, p = 0.007), both observed in the couples' UBL arm at 24 months' follow-up relative to the control arm. There was a significant increase in symptoms of moderate depression among women in the women's UBL arm only (AOR = 1.65, 95% CI 1.13-2.41, p = 0.010), again relative to the control arm. There was no evidence of shifts in symptoms of mild or severe depression. The primary limitation of this study is the reliance on self-reported data around sensitive behaviors.
CONCLUSIONS


The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm. Further research should explore how to optimize IPV prevention interventions to target related risks of mental health and substance use.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02311699; Socialscienceregistry.org AEARCTR-0000211.",2020,"The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm.","['106 households were randomly sampled, and households in the intervention arms were invited to participate in', 'men, women, and couples in Ethiopia', 'A sample of 64 villages in Gurague zone, Ethiopia', '6,770 respondents surveyed in 2014-2015, and follow-up data were available from 88% of baseline respondents surveyed in 2017-2018; the majority of respondents report no education, and 61% are Muslim', 'women who experience violence', 'Intimate partner violence (IPV']","['intimate partner violence prevention intervention', 'short educational session on IPV', 'UBL, consisting of 14 sessions delivered by trained facilitators', 'UBL intervention']","['Patient Health Questionnaire (PHQ-9', 'symptoms of mild or severe depression', 'symptoms of moderate depression', 'symptoms of depression', 'probability of frequent khat use self', 'frequent past-year alcohol intoxication self', 'depressive symptoms']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0066582', 'cui_str': 'Catha edulis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]",106.0,0.141212,"The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leight', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'Ethiopian Public Health Association, Addis Ababa, Ethiopia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Verani', 'Affiliation': 'CARE, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Tewolde', 'Affiliation': 'EngenderHealth, Addis Ababa, Ethiopia.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003131']
1811,32814461,"Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials.","Chronic activation of the type I interferon (IFN) pathway plays a critical role in systemic lupus erythematosus (SLE) pathogenesis. Anifrolumab is a human monoclonal antibody to the type I IFN receptor subunit 1, which blocks the action of type I IFNs. Two phase 3 studies (TULIP-1 and TULIP-2) and a phase 2b study (MUSE) provide substantial evidence for the efficacy and safety of anifrolumab for moderately to severely active SLE. In all three studies, monthly intravenous anifrolumab 300 mg was associated with treatment differences >16% compared with placebo at Week 52 in British Isles Lupus Assessment Group-based Composite Lupus Assessment response rates. The combined data across a range of other clinically significant endpoints (e.g. oral corticosteroid reduction, improved skin disease, flare reduction) further support the efficacy of anifrolumab for SLE treatment. The safety profile of anifrolumab was generally similar across all studies; serious adverse events occurred in 8-16% and 16-19% of patients receiving anifrolumab and placebo, respectively. Herpes zoster incidence was greater with anifrolumab (≤7%) vs placebo (≤2%). Evidence from these clinical trials suggests that in patients with active SLE, anifrolumab is superior to placebo in achieving composite endpoints of disease activity response and oral corticosteroid reduction.",2020,Herpes zoster incidence was greater with anifrolumab (≤7%) vs placebo (≤2%).,['Systemic Lupus Erythematosus'],['placebo'],"['safety profile of anifrolumab', 'serious adverse events', 'Herpes zoster incidence', 'skin disease, flare reduction']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519739', 'cui_str': 'anifrolumab'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.282096,Herpes zoster incidence was greater with anifrolumab (≤7%) vs placebo (≤2%).,"[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Tummala', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}]",Modern rheumatology,['10.1080/14397595.2020.1812201']
1812,32818325,Randomized trial of cognitive behaviour group therapy and a mindfulness-based intervention for social anxiety disorder: Preliminary findings.,"Recent studies have evaluated the possible efficacy of mindfulness-based interventions (MBIs) for social anxiety disorder (SAD). However, few trials have compared MBIs with a first-line treatment. This study evaluated the relative efficacy of an MBI adapted for SAD (MBI-SAD) to cognitive behaviour group therapy (CBGT) for SAD. Participants were randomized to 12 weekly group sessions of the MBI-SAD (n = 52) or CBGT (n = 45). Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity. The difference between the MBI-SAD and CBGT exceeded the prespecified noninferiority margin for our primary outcome the Liebowitz Social Anxiety Scale, but findings are inconclusive as the width of the confidence interval extended in both directions surrounding the noninferiority margin. The MBI-SAD compared favourably with CBGT in improving other indices of well-being (depression, self-esteem, satisfaction with life, social adjustment). Contrary to expectation, the MBI-SAD did not produce greater changes in mindfulness and self-compassion than CBGT. Overall, results confirm that CBGT is robust treatment for SAD and should be considered as first-line treatment.",2020,Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity.,['Social Anxiety Disorder'],"['MBI-SAD (n=52) or CBGT', 'Cognitive Behavior Group Therapy and a Mindfulness-based Intervention', 'CBGT', 'MBI adapted for SAD (MBI-SAD) to cognitive behavior group therapy (CBGT', 'MBI-SAD', 'mindfulness-based interventions (MBIs']","['MBI-SAD and CBGT', 'Liebowtiz Social Anxiety Scale', 'clinician- and self-rated social anxiety severity', 'mindfulness and self-compassion', 'indices of well-being (depression, self-esteem, satisfaction with life, social adjustment']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0215358,Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity.,"[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Koszycki', 'Affiliation': 'Faculty of Education (Counselling Psychology), University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Guérin', 'Affiliation': 'Montfort Hospital, Institut du Savoir Montfort, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'DiMillo', 'Affiliation': 'Montfort Hospital, Institut du Savoir Montfort, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bradwejn', 'Affiliation': 'Faculty of Medicine (Psychiatry), University of Ottawa, Ottawa, Ontario.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2502']
1813,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2020,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Adelaide Business School, The University of Adelaide, SA, 5005, Australia. Electronic address: Armando.Corsi@adelaide.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
1814,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
1815,32818720,A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors.,"OBJECTIVE


Interventions for fear of recurrence (FOR) of cancer have nominal effects, perhaps due to limited integration of empirically supported skills. This pilot trial tested the acceptability and feasibility of a multimodal, mind-body resiliency intervention targeting FOR among survivors of various cancers.
METHODS


Early stage cancer survivors 3-30 months post-treatment were recruited to participate in an eight-session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR. Primary outcomes were feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance). Patient-reported outcomes (FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills) were collected at baseline, post-intervention, +1 month, and +3 months. Exit interviews assessed survivors' reported benefits.
RESULTS


Participants (N = 4 groups, 23 survivors, enrollment response rate = 58%) included survivors of seven common cancer types who were on average 12 months post-treatment. Attendance was high (M = 6.1 sessions), and 96% of survivors completed all surveys. Sustained increases in relaxation skills practice 3+ days/week were reported (baseline = 16%, post-intervention = 76%, +3 months = 71%). Most sessions (87%) were rated as highly or very highly acceptable. Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes. Exit interviews revealed behavioral, cognitive, emotional, and existential benefits.
CONCLUSIONS


The targeted mind-body resiliency intervention shows promising acceptability, feasibility, and favorable changes in FOR and coping skills practice. Further adaptation and testing in a randomized trial are warranted. ClinicalTrials.govRegistration Number: NCT03695406.",2020,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","['survivors of various cancers', 'Cancer Survivors', 'Early stage cancer survivors 330\xa0months post-treatment were recruited to participate in an eight']","['multimodal, mind-body resiliency intervention', 'session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR']","['FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills', 'behavioral, cognitive, emotional, and existential benefits', 'feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance', 'FOR severity', 'relaxation skills practice']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",,0.129392,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America. Electronic address: hall@mgh.harvard.edu.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110215']
1816,32819616,"Erratum to: Pollack A, Chinea FM, Bossart E, Kwon D, Abramowitz MC, Lynne C, Jorda M, Marples B, Patel VN, Wu XD, Reis I, Studenski MT, Casillas J, Stoyanova R. Phase I Trial of MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD) Boost Radiation Therapy. Int J Radiat Oncol Biol Phys 2020;107:305-315.",,2020,,[],"['MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD', 'Int J Radiat Oncol Biol', 'Boost Radiation Therapy']",[],[],"[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}]",[],,0.0165785,,[],"International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.061']
1817,32819728,[Comparison of two doses of intra-articular tranexamic acid on postoperative bleeding in total knee arthroplasty: a randomized clinical trial].,"INTRODUCTION


Tranexamic Acid (TXA), an antifibrinolytic that inhibits the fibrinolytic activity of plasmin is used to decrease perioperative blood loss and transfusion requirements in orthopedic surgery. The aim of our study was to compare postoperative bleeding in two intra-articular doses (1g and 2g) of tranexamic acid in adult patients undergoing unilateral total knee replacement.
METHOD


We conducted a single-operator, randomized, and controlled, double-blind study in two groups. The G1 group received 1g of intra-articular TXA and the G2 group 2g of intra-articular TXA. Both groups received 15mg.kg -1  IV before the surgical incision (TXA induction dose) and then 10mg.kg -1 , orally, 6 and 12hours after the induction dose of TXA. The primary endpoint was bleeding measured by blood loss in postoperative drainage. Secondary outcomes were change in hemoglobin and hematocrit levels on the first and third postoperative days, and the need for transfusion during hospitalization.
RESULTS


In total, 100 patients were randomized, and 100 were included in the analysis. Blood loss in postoperative drainage was similar in both groups (200±50 vs. 250±50mL, G1 and G2 groups respectively). Change in hematocrit and hemoglobin values (% of change) between preoperative and day 3 were not statically significant between groups G1 and G2 (18±5 vs. 21±4; 21±7 vs. 22±5 respectively). No patients received blood transfusion.
CONCLUSIONS


Our study did not show superiority of 2g of intra-articular tranexamic acid compared to 1g. ClinicalTrials.gov Identifier NCT04085575.",2020,"Blood loss in postoperative drainage was similar in both groups (200±50 vs. 250±50mL, G1 and G2 groups respectively).","['total knee arthroplasty', 'adult patients undergoing unilateral total knee replacement', '100 patients were randomized, and 100 were included in the analysis']","['TXA', 'intra-articular TXA and the G2 group 2g of intra-articular TXA', 'intra-articular tranexamic acid', 'Tranexamic Acid (TXA', 'tranexamic acid']","['Blood loss in postoperative drainage', 'change in hemoglobin and hematocrit levels on the first and third postoperative days, and the need for transfusion during hospitalization', 'bleeding measured by blood loss in postoperative drainage', 'hematocrit and hemoglobin values', 'postoperative bleeding']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}]",100.0,0.369044,"Blood loss in postoperative drainage was similar in both groups (200±50 vs. 250±50mL, G1 and G2 groups respectively).","[{'ForeName': 'Edmundo Pereira de', 'Initials': 'EP', 'LastName': 'Souza Neto', 'Affiliation': ""Centre Hospitalier de Montauban, Département d'Anesthésie, Montauban, France. Electronic address: edmundo.pereira-de-souza@hotmail.fr.""}, {'ForeName': 'Gorka', 'Initials': 'G', 'LastName': 'Usandizaga', 'Affiliation': 'Centre Hospitalier de Montauban, Département de Chirurgie Orthopédique et Traumatologie, Montauban, France.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.015']
1818,32820003,"Correction: Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: protocol of a prospective, multicentre, superiority, randomised controlled trial.",,2020,,['patients recovering from acute exacerbation of chronic obstructive pulmonary disease'],['PIFR-based optimised inhalation therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}]",[],,0.116939,,[],BMJ open,['10.1136/bmjopen-2019-034804corr1']
1819,32774580,Erratum: Uncomplicated percutaneous IVC filter removal following implantation time of 6033 days.,[This corrects the article DOI: 10.1016/j.radcr.2020.05.008.].,2020,[This corrects the article DOI: 10.1016/j.radcr.2020.05.008.].,['Erratum'],[],[],[],[],[],,0.0303462,[This corrects the article DOI: 10.1016/j.radcr.2020.05.008.].,"[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Michell', 'Affiliation': 'Department of Radiology, Larner College of Medicine, University of Vermont Medical Center, 111 Colchester Ave., Burlingon, VT, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Johnston', 'Affiliation': 'Department of Radiology, Larner College of Medicine, University of Vermont Medical Center, 111 Colchester Ave., Burlingon, VT, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Morris', 'Affiliation': 'Department of Radiology, Larner College of Medicine, University of Vermont Medical Center, 111 Colchester Ave., Burlingon, VT, USA.'}]",Radiology case reports,['10.1016/j.radcr.2020.06.025']
1820,32777706,Comparison of the efficacy and safety of recombinant human growth hormone in treating idiopathic short stature and growth hormone deficiency in children.,"PURPOSE


The present study aimed to compare the efficacy and safety of recombinant human growth hormone (rhGH) therapy between children with idiopathic short stature (ISS) and growth hormone deficiency (GHD).
METHODS


A total of 150 pediatric patients with ISS and 153 pediatric patients with GHD who received rhGH treatment for more than one year from 2005 to 2016 were enrolled. Growth velocity (GV); height standard deviation (HtSD); insulin-like growth factor-1 standard deviation (IGF-1SD); body mass index (BMI); and the incidence of fasting hyperglycemia, fasting hyperinsulinemia, and hypothyroidism were recorded and compared.
RESULTS


At the beginning of treatment, chronological age, bone age, height, and BMI were not statistically significant between the two groups. rhGH dosage in ISS was significantly higher compared with GHD (P = 0). GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05). HtSD increased in the two groups after rhGH therapy. HtSD at the beginning and after three years of therapy was not different between groups except for after half a year of therapy. HtSD in patients with ISS was significantly higher compared with GHD (P < 0 .05). The incidence of hypothyroidism was significantly higher in the GHD group compared with the ISS group (13.72% vs. 6.0%; P < 0.05). Moreover, the incidence of hyperinsulinemia was significantly higher in the ISS group compared with the GHD group (15.33% vs. 7.84%; P < 0 .05).
CONCLUSIONS


rhGH increases growth in children with ISS and GHD. Fasting insulin and thyroid function were closely monitored for long-term follow up.",2020,"GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05).","['children with ISS and GHD', 'children with idiopathic short stature (ISS) and growth hormone deficiency (GHD', 'children', 'patients with ISS', '150 pediatric patients with ISS and 153 pediatric patients with GHD who received rhGH treatment for more than one year from 2005 to 2016 were enrolled']","['recombinant human growth hormone', 'GHD', 'recombinant human growth hormone (rhGH) therapy']","['incidence of hyperinsulinemia', 'Fasting insulin and thyroid function', 'efficacy and safety', 'Growth velocity (GV); height standard deviation (HtSD); insulin-like growth factor-1 standard deviation (IGF-1SD); body mass index (BMI); and the incidence of fasting hyperglycemia, fasting hyperinsulinemia, and hypothyroidism', 'incidence of hypothyroidism', 'HtSD', 'rhGH dosage in ISS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}]",150.0,0.0207075,"GV from half a year to three years after rhGH therapy was higher in the GHD group compared with the ISS group, but the differences were not statistically significant (P > 0 .05).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Han-Hua', 'Initials': 'HH', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Luo', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.'}, {'ForeName': 'Yan-Qin', 'Initials': 'YQ', 'LastName': 'Ying', 'Affiliation': 'Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. Electronic address: yingyanqin@126.com.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101331']
1821,32773206,"Corrigendum to ""Can personalized treatment prediction improve the outcomes, compared with the group average approach, in a randomized trial? Developing and validating a multivariable prediction model in a pragmatic megatrial of acute treatment for major depression"". [Journal of Affective Disorders 274 (2020) 690-697].",,2020,,['Journal of Affective Disorders 274 (2020) 690-697'],[],[],"[{'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]",[],[],,0.0306846,,"[{'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine / School of Public Health, Kyoto, Japan. Electronic address: furukawa@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Thomas P A', 'Initials': 'TPA', 'LastName': 'Debray', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands. Electronic address: t.debray@umcutrecht.nl.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan. Electronic address: mitsuhiko_yamada@ncnp.go.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic, Nagoya, Japan. Electronic address: aratama8177@yahoo.co.jp.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Seo', 'Affiliation': 'Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland. Electronic address: swj8874@gmail.com.'}, {'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Efthimiou', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Switzerland. Electronic address: oremiou@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.018']
1822,32791048,"Sorafenib maintenance in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised phase 3 trial.","BACKGROUND


Findings of retrospective studies suggest that sorafenib maintenance post-transplantation might reduce relapse in patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. We investigated the efficacy and tolerability of sorafenib maintenance post-transplantation in this population.
METHODS


We did an open-label, randomised phase 3 trial at seven hospitals in China. Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation. Patients were randomly assigned (1:1) to sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control) at 30-60 days post-transplantation. Randomisation was done with permuted blocks (block size four) and implemented through an interactive web-based randomisation system. The primary endpoint was the 1-year cumulative incidence of relapse in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02474290; the trial is complete.
FINDINGS


Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to sorafenib maintenance (n=100) or control (n=102). Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0). The 1-year cumulative incidence of relapse was 7·0% (95% CI 3·1-13·1) in the sorafenib group and 24·5% (16·6-33·2) in the control group (hazard ratio 0·25, 95% CI 0·11-0·57; p=0·0010). Within 210 days post-transplantation, the most common grade 3 and 4 adverse events were infections (25 [25%] of 100 patients in the sorafenib group vs 24 [24%] of 102 in the control group), acute graft-versus-host-disease (GVHD; 23 [23%] of 100 vs 21 [21%] of 102), chronic GVHD (18 [18%] of 99 vs 17 [17%] of 99), and haematological toxicity (15 [15%] of 100 vs seven [7%] of 102). There were no treatment-related deaths.
INTERPRETATION


Sorafenib maintenance post-transplantation can reduce relapse and is well tolerated in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. This strategy could be a suitable therapeutic option for patients with FLT3-ITD acute myeloid leukaemia.
FUNDING


None.",2020,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"['Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to', 'patients with FLT3-ITD acute myeloid leukaemia', 'patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation', 'Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation', 'seven hospitals in China', 'n=100) or control (n=102', 'patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation']","['sorafenib', 'sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control', 'Sorafenib maintenance', 'sorafenib maintenance post-transplantation', 'sorafenib maintenance']","['chronic GVHD', '1-year cumulative incidence of relapse', 'efficacy and tolerability', 'haematological toxicity', 'acute graft-versus-host-disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018957', 'cui_str': 'Hematopoietic system structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}]",202.0,0.369632,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xuan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xinquan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Department of Hematology, First People's Hospital of Chenzhou, Chenzhou, China.""}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chunzi', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Sanfang', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qifa', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. Electronic address: liuqifa628@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30455-1']
1823,32791086,Proteinuria Reduction and Kidney Survival in Focal Segmental Glomerulosclerosis.,"RATIONALE & OBJECTIVE


Remission of proteinuria has been shown to be associated with lower rates of kidney disease progression among people with focal segmental glomerulosclerosis (FSGS). The goal of this study was to evaluate if reductions in proteinuria following treatment are associated with greater kidney survival.
STUDY DESIGN


Cohort analysis of clinical trial participants SETTING & PARTICIPANTS: Patients with steroid resistant FSGS enrolled in a randomized treatment trial that compared cyclosporine to mycophenolate mofetil plus dexamethasone.
PREDICTORS


Reduction in proteinuria measured during 26 weeks after initiating treatment OUTCOMES: Repeated measures of estimated glomerular filtration rate (eGFR) and, time to end-stage kidney disease (ESKD) or death assessed between 26 weeks and 54 months after randomization ANALYTIC APPROACH: Multivariable, linear-mixed effects models with subject-specific slope and intercept to estimate the association of change in proteinuria over 26 weeks while receiving treatment with the subsequent slope of change in eGFR. Multivariable, time-varying Cox-proportional hazards models were used to estimate the association of changes in proteinuria with time to ESKD or death.
RESULTS


138 of 192 trial participants were included. Changes in proteinuria over 26 weeks were significantly related to eGFR slope. A 1 unit reduction in log-transformed urinary protein:creatinine ratio was associated with a 3.90 ml/year rise in eGFR (95% CI=2.01 to 5.79). This difference remained significant after adjusting for complete remission. There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
LIMITATIONS


Limited to individuals with steroid-resistant FSGS followed for a maximum of five-years.
CONCLUSIONS


These findings provide evidence for the benefit of urinary protein reduction in FSGS. Reductions in proteinuria warrant further evaluation as a potential surrogate for preservation of kidney function that may inform the design of future clinical trials.",2020,"There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
","['people with focal segmental glomerulosclerosis (FSGS', 'individuals with steroid-resistant FSGS followed for a maximum of five-years', '138 of 192 trial participants were included', 'Patients with steroid resistant FSGS enrolled']",['cyclosporine to mycophenolate mofetil plus dexamethasone'],"['glomerular filtration rate (eGFR) and, time to end-stage kidney disease (ESKD) or death', 'log-transformed urinary protein:creatinine ratio', 'Proteinuria Reduction and Kidney Survival', 'Changes in proteinuria']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017668', 'cui_str': 'Focal glomerular sclerosis'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.167968,"There was an analogous relationship between time-varying proteinuria and time to end-stage kidney disease: the HR for ESKD or death per 1 unit reduction in log-transformed urinary protein-creatinine ratio was 0.23 (95% CI=0.12 to 0.44).
","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Troost', 'Affiliation': 'Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, MI, USA. Electronic address: troostj@med.umich.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Trachtman', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, New York University Langone Health, New York, NY, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Kaskel', 'Affiliation': ""Division of Pediatric Nephrology, Children's Hospital at Montefiore, Bronx, New York, USA.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Marva M', 'Initials': 'MM', 'LastName': 'Moxey-Mims', 'Affiliation': ""Division of Nephrology, Children's National Hospital, Department of Pediatrics, The George Washington University School of Medicine, Washington DC, USA.""}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Fine', 'Affiliation': 'Stony Brook University Medical Center, School of Medicine, Stony Brook, New York, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences at the Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Kopp', 'Affiliation': 'Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Walsh', 'Affiliation': 'Goldfinch Bio, Cambridge, MA, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Debbie S', 'Initials': 'DS', 'LastName': 'Gipson', 'Affiliation': 'Division of Nephrology, Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.04.014']
1824,32791318,Improving Child Behaviors and Parental Stress: A Randomized Trial of Child Adult Relationship Enhancement in Primary Care.,"BACKGROUND


Prior single-site evaluations of Child Adult Relationship Enhancement in Primary Care (PriCARE), a 6-session group parent training, demonstrated reductions in child behavioral problems and improvements in positive parenting attitudes.
OBJECTIVE


To measure the impact of PriCARE on disruptive child behaviors, parenting stress, and parenting attitudes in a multisite study.
METHODS


Caregivers of children 2- to 6-year-old with behavior concerns recruited from 4 pediatric primary care practices were randomized 2:1 to PriCARE intervention (n = 119) or waitlist control (n = 55). Seventy-nine percent of caregivers identified as Black and 59% had annual household incomes under $22,000. Child behavior, parenting stress, and parenting attitudes were measured at baseline and 2 to 3 months after intervention using the Eyberg Child Behavior Inventory, Parenting Stress Index, and Adult-Adolescent Parenting Inventory-2. Marginal standardization implemented in a linear regression compared mean change scores from baseline to follow-up by treatment arm while accounting for clustering by site.
RESULTS


Mean change scores from baseline to follow-up demonstrated greater improvements (decreases) in Eyberg Child Behavior Inventory problem scores but not intensity scores in the PriCARE arm compared to control, (problem: -4.4 [-7.5, -1.2] vs -1.8 [-4.1, 0.4], P= .004; intensity: -17.6 [-28.3, -6.9] vs -10.4 [-18.1, -2.6], P= .255). Decreases in parenting stress were greater in the PriCARE arm compared to control (-3.3 [-4.3, -2.3] vs 0 [-2.5, 2.5], P= .025). Parenting attitudes showed no significant changes (all P> .10).
CONCLUSIONS


PriCARE showed promise in improving parental perceptions of the severity of child behaviors and decreasing parenting stress but did not have an observed impact on parenting attitudes.",2020,"Mean change scores from baseline to follow-up demonstrated greater improvements (decreases) in ECBI problem scores but not intensity scores in the PriCARE arm compared to control, [problem: -4.4 (-7.5, -1.2) versus -1.8","['Caregivers of children 2- to 6-years-old with behavior concerns recruited from 4 pediatric primary care practices', '79% of caregivers identified as Black and 59% had annual household incomes under $22,000']","['PriCARE', 'waitlist control', 'PriCARE intervention']","['disruptive child behaviors, parenting stress, and parenting attitudes', 'child behaviors and parental stress', 'Eyberg Child Behavior Inventory (ECBI), Parenting Stress Index (PSI), and Adult-Adolescent Parenting Inventory-2 (AAPI-2', 'Child behavior, parenting stress, and parenting attitudes', 'parenting stress', 'ECBI problem scores', 'Mean change scores']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0435019,"Mean change scores from baseline to follow-up demonstrated greater improvements (decreases) in ECBI problem scores but not intensity scores in the PriCARE arm compared to control, [problem: -4.4 (-7.5, -1.2) versus -1.8","[{'ForeName': 'Joanne N', 'Initials': 'JN', 'LastName': 'Wood', 'Affiliation': ""Division of General Pediatrics, The Children's Hospital of Philadelphia (JN Wood and PV Scribano), Philadelphia, Pa; PolicyLab, The Children's Hospital of Philadelphia (JN Wood and D Kratchman), Philadelphia, Pa; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania (JN Wood, PV Scribano, and S Berkowitz), Philadelphia, Pa. Electronic address: woodjo@email.chop.edu.""}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kratchman', 'Affiliation': ""PolicyLab, The Children's Hospital of Philadelphia (JN Wood and D Kratchman), Philadelphia, Pa.""}, {'ForeName': 'Philip V', 'Initials': 'PV', 'LastName': 'Scribano', 'Affiliation': ""Division of General Pediatrics, The Children's Hospital of Philadelphia (JN Wood and PV Scribano), Philadelphia, Pa; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania (JN Wood, PV Scribano, and S Berkowitz), Philadelphia, Pa.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania (JN Wood, PV Scribano, and S Berkowitz), Philadelphia, Pa.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schilling', 'Affiliation': 'Department of Pediatrics, University of North Carolina (S Schilling), Chapel Hill, NC. Dr Berkowitz is now with Department of Psychiatry, University of Colorado, School of Medicine, Aurora, Colo.'}]",Academic pediatrics,['10.1016/j.acap.2020.08.002']
1825,32792131,[PECS I block for postoperative analgesia in patients undergoing breast augmentation surgery: a randomized double-blind placebo-controlled study].,"BACKGROUND AND OBJECTIVES


PECS I block was first described for surgery involving the pectoralis muscles. No randomized clinical trial has been conducted on surgeries that directly involve these muscles, such as subpectoral breast augmentation. We hypothesized that PECS I block would decrease pain in the postoperative period in this population.
METHODS


This was a randomized, double-blind, placebo-controlled trial in women undergoing subpectoral breast augmentation surgery. PECS I block was performed using 0.4 mL.kg -1  of 0.9% saline on one side and bupivacaine (0.25%) on the other side, each patient being her own control. Numeric Rating Scale (NRS) pain scores (0-10) were measured at rest and during movement. The primary outcome was pain score at rest 30 minutes after arrival in the PACU. To detect a clinically significant difference of 50% in pain reduction, 14 volunteers were enrolled (power of 90% and alpha<0.05).
RESULTS


In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side. In the bupivacaine group, pain scores at rest at 5, 30 and 60 minutes and 24 hours were 4.89 (4.23-5.56; mean 95% CI), 3.75 (3.13-4.37), 3.79 (2.93-4.64), and 2.29 (1.56-3.01), respectively, whereas in the placebo group, they were 4.96 (4.32-5.60), 4.00 (3.50-4.49), 3.93 (3.12-4.73), and 2.29 (1.56-3.01), respectively.
CONCLUSIONS


PECS I block in patients undergoing breast augmentation surgery does not provide better pain relief than placebo. Therefore, the indications for PECS I block in breast augmentation surgery should be reconsidered.",2020,"In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side.","['patients undergoing breast augmentation surgery', 'women undergoing subpectoral breast augmentation surgery', '14 volunteers were enrolled (power of 90% and alpha<0.05']","['PECS I block', 'bupivacaine', 'placebo']","['pain scores', 'pain relief', 'reduced pain', 'pain', 'pain score', 'Numeric Rating Scale (NRS) pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",14.0,0.754972,"In the PACU, three patients had no difference in pain between sides, five had reduced pain on the placebo side, and six had reduced pain on the bupivacaine side.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Desroches', 'Affiliation': 'Clinique Chirurgicale de Laval, Department of Anesthesiology, Laval, Canada.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Department of Anesthesiology, Montreal, Canada. Electronic address: maxim.roy20@gmail.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Belliveau', 'Affiliation': 'Hôtel-Dieu de St Jérôme, Department of Anesthesiology, Saint-Jérôme, Canada.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Leblanc', 'Affiliation': 'Clinique Chirurgicale de Laval, Department of Surgery, Laval, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Beaulieu', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Department of Anesthesiology, Montreal, Canada.""}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.013']
1826,32797382,Implementation of Universal HIV Testing and Treatment to Reduce HIV Incidence in Botswana: the Ya Tsie Study.,"PURPOSE OF REVIEW


Antiretroviral treatment (ART) can dramatically reduce the risk of HIV transmission, but the feasibility of scaling up HIV testing, linkage and treatment to very high population levels, and its impact on population HIV incidence, were unknown. We review key findings from a community-randomized trial in which we evaluated the impact of ""universal test and treat"" (UTT) on population HIV incidence in Botswana, a resource-constrained country with both high HIV prevalence and high ART coverage before study inception.
RECENT FINDINGS


We conducted a community-randomized trial (the ""Ya Tsie"" trial or Botswana Combination Prevention Project (BCPP)) in 30 villages in Botswana from 2013 to 2018, with the goal of determining whether a combination of prevention interventions-with a focus on universal HIV testing and treatment-would reduce population-level HIV incidence. The intervention included universal HIV testing (home-based and mobile), active linkage to HIV care and treatment with patient tracing for persons not linking, universal ART coverage, rapid ART start (at the first clinic visit), and enhanced male circumcision services. Botswana had very high HIV diagnosis, treatment, and viral suppression levels (approaching the UNAIDS ""90-90-90"" targets) prior to intervention roll-out. By study end, we were able to exceed the overall 95-95-95 coverage target of 86%: an estimated 88% of all persons living with HIV were on ART and had viral suppression in the Ya Tsie intervention arm. In addition, annual HIV incidence was 30% lower in the intervention arm as compared with the control arm over a 29-month follow-up period. With universal HIV testing and relatively simple linkage activities, it was possible to achieve one of the highest reported population levels of HIV diagnosis, linkage to care, and viral suppression globally and to reduce population HIV incidence by about one-third over a short period of time (< 3 years). We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage. Universal community-based HIV testing and tracing of individuals through the HIV care cascade were key intervention components.",2020,We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage.,"['30 villages in Botswana from 2013 to 2018, with the goal of determining whether a combination of prevention interventions-with a focus on universal HIV testing and treatment-would reduce population-level HIV incidence', 'overall 95-95-95 coverage target of 86%: an estimated 88% of all persons living with HIV were on ART and had viral suppression in the Ya Tsie intervention arm', 'population HIV incidence in Botswana, a resource-constrained country with both high HIV prevalence and high ART coverage before study inception']","['Botswana Combination Prevention Project (BCPP', 'universal test and treat"" (UTT', 'universal HIV testing (home-based and mobile), active linkage to HIV care and treatment with patient tracing for persons not linking, universal ART coverage, rapid ART start']","['viral suppression levels', 'annual HIV incidence', 'population viral suppression']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.0761354,We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage.,"[{'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Brigham and Women's Hospital, PBB-A4, 15 Francis Street, Boston, MA, 02115, USA. slockman@hsph.harvard.edu.""}, {'ForeName': 'Molly Pretorius', 'Initials': 'MP', 'LastName': 'Holme', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Wirth', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Essex', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Current HIV/AIDS reports,['10.1007/s11904-020-00523-0']
1827,32798144,Study protocol for a multi-institutional randomized phase III study comparing combined everolimus plus lanreotide therapy and everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors; Japan Clinical Oncology Group Study JCOG1901 (STARTER-NET study).,"Everolimus is recognized as one of the standard drugs for the treatment of unresectable or recurrent gastroenteropancreatic neuroendocrine tumors (NET). However, recent evidence has suggested that addition of somatostatin analogs to everolimus may yield better survival outcomes as compared to everolimus alone. In April 2020, we have initiated a randomized phase III trial in Japan, to confirm the superiority of combined everolimus plus lanreotide therapy over everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic NETs with poor prognostic factors (Ki-67 labeling index: LI 5%-20% or Ki-67 LI < 5% with diffuse liver metastases). We plan to enroll a total of 250 patients from 76 institutions over an accrual period of 5 years. The primary endpoint is progression-free survival. The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints. This trial is registered with the Japan Registry of Clinical Trials as jRCT1031200023 [https://jrct.niph.go.jp/en-latest-detail/jRCT1031200023].",2020,"The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints.","['250 patients from 76 institutions over an accrual period of 5 years', 'patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors', 'patients with unresectable or recurrent gastroenteropancreatic NETs with poor prognostic factors (Ki-67 labeling index: LI 5%-20% or Ki-67 LI']","['Everolimus', 'combined everolimus plus lanreotide therapy and everolimus monotherapy', 'combined everolimus plus lanreotide therapy over everolimus monotherapy']","['progression-free survival', 'overall survival, with response rate, disease control rate, and proportion of patients with adverse events']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C2930967', 'cui_str': 'Gastro-enteropancreatic neuroendocrine tumor'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",250.0,0.0489079,"The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints.","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shimoyama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Hijioka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: shijioka@ncc.go.jp.'}, {'ForeName': 'Nobumasa', 'Initials': 'N', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Machida', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Honma', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.07.010']
1828,32798834,The role of parental psychological flexibility in childhood asthma management: An analysis of cross-lagged panel models.,"OBJECTIVE


This is a secondary analysis of a previously reported randomized controlled trial, aimed at examining the mediating role of parental psychological flexibility (PF) in an Acceptance and Commitment Therapy (ACT)-based childhood asthma management program for parents.
METHODS


The participants were 168 parents (mean age (SD) = 38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD) = 6.81 (2.50) years; 62% boys). They were randomly allocated to either the program composed of a four-session, group-based ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group). The parents underwent assessments at baseline, and immediately, 3-months, and 6-months after the intervention for the following outcomes: PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21); and the asthma symptoms and use of inhaled bronchodilators of their children.
RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
CONCLUSION


ACT makes a unique contribution to improving the health outcomes of parents and their children diagnosed with asthma through fostering parental PF.",2020,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","['childhood asthma management', 'participants were 168 parents (mean age (SD)\u202f=\u202f38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD)\u202f=\u202f6.81 (2.50) years; 62% boys', 'parents', 'parents and their children diagnosed with asthma through fostering parental PF']","['ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group', 'ACT', 'parental psychological flexibility (PF', 'inhaled bronchodilators of their children']","['nighttime symptoms', 'childhood asthma symptoms', 'parental psychological distress', 'PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21']","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",168.0,0.118973,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","[{'ForeName': 'Yuen Yu', 'Initials': 'YY', 'LastName': 'Chong', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong. Electronic address: conniechong@cuhk.edu.hk.'}, {'ForeName': 'Yim Wah', 'Initials': 'YW', 'LastName': 'Mak', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Alice Yuen', 'Initials': 'AY', 'LastName': 'Loke', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110208']
1829,32798835,"Effects of food-related behavioral activation therapy on eating styles, diet quality and body weight change: Results from the MooDFOOD Randomized Clinical Trial.","OBJECTIVE


Depression and obesity are bi-directionally related, eating styles and diet quality are two important factors associated with both. It remains uncertain if and how these two factors can be modified. Therefore the current study aims to investigate whether food-related behavioral activation therapy (F-BA), targeting mood, dietary habits and food related behavior, can improve eating styles, and diet quality and reduce body weight in adults with overweight or obesity and subsyndromal depressive symptoms.
METHODS


Data were derived from the MooDFOOD prevention trial, a 2x2 factorial RCT investigating the effect of nutritional strategies on prevention of depression. Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight were analyzed among 1025 adults who either received F-BA or no intervention for 12 months. Intervention effect was tested by longitudinal analysis of covariance using mixed model analysis.
RESULTS


The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA. The effect of the F-BA therapy on emotional and uncontrolled eating was stronger in those with higher baseline depressive symptoms (IDS-SR). The F-BA did also lead to small improvements in MDS (β=1.95, p<.001), but not to change in body weight.
CONCLUSION


Our trial showed no reduction in bodyweight, but provides support for the possibility to improve both unhealthy eating styles and diet quality using an intervention targeting these specifically, although effects were small [Trial registration: clinicaltrials.gov NCT02529423].",2020,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","['adults with overweight or obesity and subsyndromal depressive symptoms', '1025 adults who either received']","['food-related behavioral activation therapy', 'F-BA therapy', 'F-BA or no intervention', 'food-related behavioral activation therapy (F-BA']","['Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight', 'uncontrolled eating', 'emotional and uncontrolled eating', 'eating styles, and diet quality and reduce body weight', 'cognitive restrained eating', 'emotional', 'eating styles, diet quality and body weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",1025.0,0.112594,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","[{'ForeName': 'Nadine P G', 'Initials': 'NPG', 'LastName': 'Paans', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands. Electronic address: n.paans@ggzingeest.nl.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatic and Psychotherapy, Senckenberg Distinguished Professorship, Goethe-University Frankfurt, Frankfurt A.M., Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Medical Faculty, Leipzig, Germany.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110206']
1830,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
1831,32801102,"Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results.","The relationships between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life (HRQoL) may be important for determining the overall impact of medication therapy on patients with epilepsy. The objectives of these post hoc analyses of the global Phase III 093-0304 trial (NCT00988429, Study 304) of adjunctive eslicarbazepine acetate (ESL) in patients with refractory focal (partial-onset) seizures (FS) were to evaluate associations between seizure severity change, measured by the Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS). The analyses were conducted on the per-protocol population (PPP) of patients who were randomized to a placebo arm (n = 188) or an ESL-active group that included treatment with adjunctive ESL 800 mg once daily (QD; n = 184) or adjunctive ESL 1200 mg QD (n = 175). General linear models (GLM) were used to measure the association between SSQ change and patient baseline characteristics or percentage change in the SSF from baseline. Associations between changes in the SSQ and changes in the QOLIE-31 and MADRS were examined using GLM with patient baseline characteristics as covariates. Subgroup analyses were performed for patients in the ESL-active group and those treated with ESL 800 mg or ESL 1200 mg. Minimal clinically important difference (MCIDs) thresholds were used to assess improvements in SSQ scores. The analyses included 547 per-protocol patients. Patients using 1 antiepileptic drug (AED) at baseline had greater improvements in the SSQ compared with those receiving 2 AEDs (P = 0.0606). Treatment with ESL 1200 mg was significantly associated with clinically meaningful improvements in the SSQ (P = 0.0005). The SSQ improvements were significantly associated with an SSF reduction of ≥75%, compared with no reduction (P < 0.0001). In the PPP and the ESL-active group, SSQ improvements were significantly associated with improvements in QOLIE-31 Total Score (TS; P < 0.0001) and the Seizure Worry (SW; P < 0.0001) and Social Functioning (SF; P = 0.0030) subscales. In the ESL 1200 mg subgroup, SSQ improvements were significantly associated with improvements in QOLIE-31 TS (P < 0.0001) and the SW (P < 0.0001) and Energy/Fatigue (EF; P = 0.0007) subscales. In the ESL 800 mg subgroup, improvements in the SSQ were significantly associated with improvements in QOLIE-31 TS (P = 0.0362) and the SW (P = 0.0241) subscale. There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL. These findings demonstrated that in this clinical trial population, adding ESL to baseline AED therapy had utility for decreasing seizure severity and improving HRQoL. There were no significant associations between changes in seizure severity and changes in depressive symptoms in patients with FS.",2020,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"['patients with refractory focal (partial-onset) seizures (FS', 'patients with epilepsy', 'patients with focal seizures treated with']","['adjunctive eslicarbazepine acetate', 'adjunctive eslicarbazepine acetate (ESL', 'adjunctive ESL 1200\u202fmg QD', 'ESL-active group that included treatment with adjunctive ESL 800', 'ESL 800\u202fmg or ESL', 'ESL', 'placebo']","['SSF reduction', 'SSQ scores', 'seizure frequency, and health-related quality of life (HRQoL', 'seizure frequency, and health-related quality of life', 'SSQ', 'QOLIE-31 Total Score', 'Seizure Worry', 'QOLIE-31 and MADRS', 'QOLIE-31 TS', 'seizure severity and improving HRQoL', 'Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social Functioning', 'seizure severity and changes in depressive symptoms', 'Energy/Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.147528,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"[{'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Cramer', 'Affiliation': 'Yale University School of Medicine and Consultant, Houston, TX 77027, United States of America. Electronic address: joyce.cramer@gmail.com.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Inc., Suite 3.02, Level 3, Building A, 97 Waterloo Road, Macquarie Corporate Centre, Macquarie Park, New South Wales 2113, Australia. Electronic address: Sam.Colman@covance.com.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Anastassopoulos', 'Affiliation': 'Covance Inc., 9801 Washingtonian Blvd., 9th. Floor, Gaithersburg, MD 20878, United States of America. Electronic address: kathryn.anastassopoulos@covance.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Darshan.Mehta@sunovion.com.'}, {'ForeName': 'G Rhys', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Gwilym.Williams@sunovion.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107312']
1832,32808234,"A mind-body lifestyle intervention enhances emotional control in patients with major depressive disorder: a randomized, controlled study.","To investigate the effects of the Dejian mind-body intervention (DMBI), on depressive symptoms and electroencephalography (EEG) changes in relation to emotional processing in patients with depression. Seventy-five age-, gender-, and education-matched participants with depression were randomly assigned to receive either Cognitive Behavior Therapy (CBT) or DMBI or were placed in a control group. Overall depressive syndrome, specific mood-related symptoms (Hamilton Psychiatric Rating Scale for Depression, Beck Depression Inventory), and EEG data were collected individually during a resting state and during affective image viewing before and after 10 weeks of intervention. After intervention, both the DMBI and CBT groups showed significantly reduced levels of overall depressive syndrome and mood-related symptoms (Ps ≤ 0.002) than the control group. In addition, the DMBI group demonstrated a significantly greater extent of elevation in fronto-posterior EEG theta coherence on the right hemisphere when viewing different mood-induction (neutral, positive, and negative) stimuli than the CBT and control groups (Ps < 0.03). The elevated intra-right fronto-posterior coherence when viewing mood-induction stimuli correlated with improved mood levels after the intervention (Ps < 0.05). Our findings also showed that, only in the DMBI group, there was a significant suppression of theta source activity at the posterior and subcortical brain regions that are known to mediate negative emotional responses and the self-absorbed mode of thinking. The findings of reduced depressive symptoms and elevated frontoposterior coherence suggest that the DMBI can enhance emotional control in depression.",2020,"After intervention, both the DMBI and CBT groups showed significantly reduced levels of overall depressive syndrome and mood-related symptoms (Ps ≤ 0.002) than the control group.","['patients with depression', 'education-matched participants with depression', 'Seventy-five age-, gender-, and', 'patients with major depressive disorder']","['A mind-body lifestyle intervention enhances emotional control', 'Cognitive Behavior Therapy (CBT) or DMBI', 'Dejian mind-body intervention (DMBI', 'DMBI']","['Overall depressive syndrome, specific mood-related symptoms (Hamilton Psychiatric Rating Scale for Depression, Beck Depression Inventory), and EEG data', 'mood levels', 'elevated intra-right fronto-posterior coherence', 'overall depressive syndrome and mood-related symptoms', 'elevation in fronto-posterior EEG theta coherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086133', 'cui_str': 'Depressive Syndrome'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0424113', 'cui_str': 'Level of mood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",,0.0365269,"After intervention, both the DMBI and CBT groups showed significantly reduced levels of overall depressive syndrome and mood-related symptoms (Ps ≤ 0.002) than the control group.","[{'ForeName': 'Yvonne M Y', 'Initials': 'YMY', 'LastName': 'Han', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Sophia L', 'Initials': 'SL', 'LastName': 'Sze', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR.'}, {'ForeName': 'Queenie Y', 'Initials': 'QY', 'LastName': 'Wong', 'Affiliation': 'Division II, Kwai Chung Hospital, Kwai Chung, Hong Kong, SAR, China.'}, {'ForeName': 'Agnes S', 'Initials': 'AS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR. aschan@psy.cuhk.edu.hk.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00819-z']
1833,32817358,"Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomised, placebo-controlled trial.","OBJECTIVE


To evaluate efficacy and safety of lacosamide (up to 12 mg/kg/day or 400 mg/day) as adjunctive treatment for uncontrolled primary generalised tonic-clonic seizures (PGTCS) in patients (≥4 years) with idiopathic generalised epilepsy (IGE).
METHODS


Phase 3, double-blind, randomised, placebo-controlled trial (SP0982; NCT02408523) in patients with IGE and PGTCS taking 1-3 concomitant antiepileptic drugs. Primary outcome was time to second PGTCS during 24-week treatment.
RESULTS


242 patients were randomised and received ≥1 dose of trial medication (lacosamide/placebo: n=121/n=121). Patients (mean age: 27.7 years; 58.7% female) had a history of generalised-onset seizures (tonic-clonic 99.6%; myoclonic 38.8%; absence 37.2%). Median treatment duration with lacosamide/placebo was 143/65 days. Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121). Median time to second PGTCS could not be estimated for lacosamide (>50% of patients did not experience a second PGTCS) and was 77.0 days for placebo. Kaplan-Meier estimated freedom from PGTCS at end of the 24-week treatment period (day 166) for lacosamide/placebo was 31.3%/17.2% (difference 14.1%; p=0.011). More patients on lacosamide than placebo had ≥50% (68.1%/46.3%) or ≥75% (57.1%/36.4%) reduction from baseline in PGTCS frequency/28 days, or observed freedom from PGTCS during treatment (27.5%/13.2%) (n=119/n=121). 96/121 (79.3%) patients on lacosamide had treatment-emergent adverse events (placebo 79/121 (65.3%)), most commonly dizziness (23.1%), somnolence (16.5%), headache (14.0%). No patients died during the trial.
CONCLUSIONS


Lacosamide was efficacious and generally safe as adjunctive treatment for uncontrolled PGTCS in patients with IGE.",2020,"Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121).","['primary generalised tonic-clonic seizures', 'uncontrolled primary generalised tonic-clonic seizures (PGTCS) in patients (≥4 years) with idiopathic generalised epilepsy (IGE', 'patients with IGE', 'patients with IGE and PGTCS taking 1-3 concomitant antiepileptic drugs', '242 patients', 'Patients (mean age: 27.7 years; 58.7% female) had a history of generalised-onset seizures (tonic-clonic 99.6%; myoclonic 38.8%; absence 37.2']","['trial medication (lacosamide/placebo', 'lacosamide', 'lacosamide/placebo', 'adjunctive lacosamide', 'placebo']","['headache', 'dizziness', 'treatment-emergent adverse events', 'time to second PGTCS', 'Efficacy and safety', 'Median time to second PGTCS', 'somnolence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",242.0,0.731704,"Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121).","[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Vossler', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA david_vossler@valleymed.org.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Knake', 'Affiliation': 'Department of Neurology, Epilepsy Centre Hessen, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Shinjuku Neuro Clinic, Tokyo, Japan.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Steiniger-Brach', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Roebling', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-323524']
1834,32817407,"Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Postoperative pain after pediatric cardiac surgery is usually treated with intravenous opioids. Recently, the focus has been on postoperative regional analgesia with the introduction of ultrasound-guided erector spinae plane blocks (ESPBs). We hypothesized that bilateral ESPB with a programmed intermittent bolus (PIB) regimen decreases postoperative morphine consumption at 48 hours and improves analgesia in children who undergo cardiac surgery.
METHODS


This randomized, double-blind, placebo-controlled study comprised 50 children who underwent cardiac surgery through midline sternotomy. The patients were allocated randomly into two groups: ultrasound-guided bilateral ESPB at the level of T3-T4 transverse process then PIB with saline infusion (group 1, n=23) or PIB with 0.2% ropivacaine (group 2, n=27). Intravenous morphine at 30 µg/kg/hour was used as rescue analgesia. Postoperative pain was assessed using the COMFORT-B score for extubation, drain removal, and mobilization, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 2, 4, 6, 8, 12, 16, 20, 24, 36, and 48 hours after surgery. Adverse events were noted.
RESULTS


The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03). Fourteen per cent of patients required rescue analgesia with morphine in group 2 compared with 41% in group 1 (p=0.05). The patients in group 2 demonstrated significantly reduced COMFORT-B scores at extubation, drain removal, and mobilization compared with those in group 1 and had reduced FLACC scale levels at 20 and 24 hours postoperatively (p=0.05 and p=0.001, respectively). No differences were reported for extubation and drain removal times or for length of hospital stay. In addition, vomiting episodes were decreased in group 2 (p=0.01).
CONCLUSIONS


In pediatric cardiac surgery, the results of this study confirm our hypothesis that bilateral ESPB analgesia with ropivacaine decreases the postoperative morphine consumption at 48 hours and demonstrates better postoperative analgesia compared with a control group.  Trial registration number  NCT03593642.",2020,The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03).,"['pediatric patients after open cardiac surgery', '50 children who underwent cardiac surgery through midline sternotomy', 'children who undergo cardiac surgery']","['opioid-sparing postoperative analgesia', 'Intravenous morphine', 'morphine', 'ropivacaine', 'PIB with 0.2% ropivacaine', 'ultrasound-guided bilateral ESPB at the level of T3-T4 transverse process then PIB with saline infusion', 'intravenous opioids', 'Bilateral ultrasound-guided thoracic erector spinae plane blocks', 'placebo']","['vomiting episodes', 'extubation and drain removal times or for length of hospital stay', 'Adverse events', 'rescue analgesia', 'reduced COMFORT-B scores at extubation, drain removal, and mobilization', 'COMFORT-B score for extubation, drain removal, and mobilization, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale', 'postoperative morphine consumption', 'FLACC scale levels', 'postoperative analgesia', 'Postoperative pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",50.0,0.598763,The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03).,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Macaire', 'Affiliation': 'Anesthesia and Pain Department, Vinmec International Hospital, Hanoi, Viet Nam.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Ho', 'Affiliation': 'Department of Cardiac Surgery, Vinmec Central Park International Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Vien', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Cardiac Surgery, Vinmec Central Park International Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Hieu', 'Initials': 'H', 'LastName': 'Phan Van', 'Affiliation': 'Department of Pharmacology, Forensic Medicine Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dinh Nguyen Thien', 'Affiliation': 'Department of Pharmacology, Forensic Medicine Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bringuier', 'Affiliation': 'Department of Biostatistics, Hopital Lapeyronie, Montpellier, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Capdevila', 'Affiliation': 'Anesthesiology and Critical Care Department and Neurosciences Institute, Inserm U1051, Hopital Lapeyronie, Montpellier, France x-capdevila@chu-montpellier.fr.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101496']
1835,32816784,"Correction:  Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase llb, randomised, double blind, placebo-controlled, dose-ranging study .",,2020,,['patients with active ankylosing spondylitis'],"['interleukin-17A and interleukin-17F with bimekizumab', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}]","[{'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.573912,,[],Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-216980corr1']
1836,32826199,"Corrigendum to ""Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial"" [Contemporary Clinical Trials 69 (2018) 83-91].",,2020,,['low back pain'],[],[],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}]",[],[],,0.0855818,,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, USA. Electronic address: France@ohio.edu.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Department of Physical Therapy, Virginia Commonwealth University, Richmond, VA, USA; Department of Physical Medicine & Rehabilitation, Virginia Commonwealth University, Richmond, VA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106120']
1837,32822362,"Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali.","BACKGROUND


Seasonal malaria chemoprevention (SMC) is now widely deployed in the Sahel, including several countries that are major contributors to the global burden of malaria. Consequently, it is important to understand whether SMC continues to provide a high level of protection and how SMC might be improved. SMC was evaluated using data from a large, household-randomised trial in Houndé, Burkina Faso and Bougouni, Mali.
METHODS AND FINDINGS


The parent trial evaluated monthly SMC plus either azithromycin (AZ) or placebo, administered as directly observed therapy 4 times per year between August and November (2014-2016). In July 2014, 19,578 children aged 3-59 months were randomised by household to study group. Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016. These analyses focus on the approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group. Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August. The incidence rate ratio comparing SMC within the past 28 days with SMC more than 35 days ago-adjusted for age, country, and household clustering-was 0.13 (95% CI: 0.08, 0.20), P < 0.001 for malaria hospitalisations and deaths from malaria and 0.21 (95% CI 0.20, 0.23), P < 0.001 for uncomplicated malaria, indicating protective efficacy of 87.4% (95% CI: 79.6%, 92.2%) and 78.3% (95% CI: 76.8%, 79.6%), respectively. The prevalence of malaria parasitaemia at weekly surveys during the rainy season and at the end of the transmission season was several times higher in children who missed the SMC course preceding the survey contact, and the smallest prevalence ratio observed was 2.98 (95% CI: 1.95, 4.54), P < 0.001. The frequency of molecular markers of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance did not increase markedly over the study period either amongst study children or amongst school-age children resident in the study areas. After 3 years of SMC deployment, the day 28 PCR-unadjusted adequate clinical and parasitological response rate of the SP + AQ regimen in children with asymptomatic malaria was 98.3% (95% CI: 88.6%, 99.8%) in Burkina Faso and 96.1% (95% CI: 91.5%, 98.2%) in Mali. Key limitations of this study are the potential overdiagnosis of uncomplicated malaria by rapid diagnostic tests and the potential for residual confounding from factors related to adherence to the monthly SMC schedule.
CONCLUSION


Despite strong evidence that SMC is providing a high level of protection, the burden of malaria remains substantial in the 2 study areas. These results emphasise the need for continuing support of SMC programmes. A fifth monthly SMC course is needed to adequately cover the whole transmission season in the study areas and in settings with similar epidemiology.
TRIAL REGISTRATION


The AZ-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT02211729.",2020,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","['In July 2014, 19,578 children aged 3-59 months', 'Houndé District, Burkina Faso and Bougouni District, Mali', 'approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group', 'Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016', 'study children or amongst school-age children resident in the study areas']","['seasonal malaria chemoprevention', 'azithromycin (AZ) or placebo', 'sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance', 'SP + AQ', 'placebo']","['prevalence of malaria parasitaemia', 'parasitological response rate', 'incidence rate ratio comparing SMC', 'smallest prevalence ratio', 'protective efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",19578.0,0.276926,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Cairns', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Serge R', 'Initials': 'SR', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Milligan', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}]",PLoS medicine,['10.1371/journal.pmed.1003214']
1838,32822417,Correction: Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial.,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,['primary care patients with obesity and depression'],[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",[],[],,0.0271133,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': ''}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': ''}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': ''}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': ''}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': ''}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Lenard I', 'Initials': 'LI', 'LastName': 'Lesser', 'Affiliation': ''}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Kristen M J', 'Initials': 'KMJ', 'LastName': 'Azar', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238276']
1839,32822692,Effect of early and late prenatal vitamin D and maternal asthma status on offspring asthma or recurrent wheeze.,"BACKGROUND


Childhood asthma developmental programming is complex. Maternal asthma is a strong risk factor for childhood asthma, whereas vitamin D (VD) has emerged as a modifiable prenatal exposure.
OBJECTIVE


Our aim was to examine the combined effect of early and late prenatal VD status in during pregnancies in women with and without asthma on childhood asthma or recurrent wheeze development.
METHODS


We conducted a cohort study using prospectively collected data from the Vitamin D Antenatal Asthma Reduction Trial, a randomized, double-blinded, placebo-controlled VD supplementation trial in pregnant women at high risk of offspring asthma (N = 806 mother-offspring pairs). 25-Hydroxyvitamin-D (25(OH)D) level was measured in early and late pregnancy. Our main exposure was an ordered variable representing early and late prenatal VD sufficiency (25(OH)D level ≥ 30 ng/mL) status during pregnancy in women with and without asthma. The primary outcome was offspring with asthma or recurrent wheeze by age 3 years. We also examined the effect of prenatal VD level on early life asthma or recurrent wheeze progression to active asthma at age 6 years.
RESULTS


Among mothers with asthma versus among mothers with early and late prenatal VD insufficiency, those with early or late VD sufficiency (adjusted odds ratio = 0.56; 95% CI = 0.31-1.00) or early and late VD sufficiency (adjusted odds ratio = 0.36; 95% CI = 0.15-0.81) had a lower risk of offspring with asthma or recurrent wheeze by age 3 years (P for trend  = .008). This protective trend was reiterated in asthma or recurrent wheeze progression to active asthma from age 3 to 6 years (P for   trend  = .04).
CONCLUSION


This study implies a protective role for VD sufficiency throughout pregnancy, particularly in attenuating the risk conferred by maternal asthma on childhood asthma or recurrent wheeze development.",2020,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
","['early life asthma/recurrent wheeze progression to active asthma at age 6 years', 'pregnant women at high risk of offspring asthma (N=806 mother-offspring pairs', 'pregnancies with and without asthma on childhood asthma/recurrent wheeze development', 'asthmatic pregnant women', 'offspring asthma or recurrent wheeze', 'pregnancies with and without asthma']","['early and late prenatal vitamin D', 'Vitamin D Antenatal Asthma Reduction Trial (VDAART', 'prenatal VD', 'placebo-controlled vitamin D supplementation']","['25-hydroxyvitamin-D [25(OH)D', 'offspring asthma or recurrent wheeze by age 3 years', 'lower risk of offspring asthma/recurrent wheeze']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",,0.10878,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
","[{'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Mass; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Golisano Children's Hospital at University of Rochester Medical Center, Rochester, NY.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center, Department of Medicine, Boston Medical Center, Boston University, Boston, Mass.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Department of Allergy and Research and Evaluation, Kaiser Permanente Southern California Region, San Diego and Pasadena, Calif.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bacharier', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University, St Louis, Mo.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schatz', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University, St Louis, Mo.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass. Electronic address: hoomi@post.harvard.edu.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.041']
1840,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis (RA). Eighty RA patients were randomized to tocilizumab (n = 40) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and glucocorticoids (GC) (n = 40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: (a)perfused boundary region (PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), (b)pulse wave velocity (PWV), (c)global LV longitudinal strain (GLS), (d)global work index (GWI) using speckle tracking echocardiography and e)C-reactive protein (CRP), malondialdehyde (MDA) and protein carbonyls (PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers (P < 0.05). Compared with baseline, tocilizumab reduced PBR(2.14 ± 0.2 versus 1.97 ± 0.2 μm; P < 0.05) while no significant differences were observed post-csDMARDs + GC(P > 0.05). Compared with csDMARDs + GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P < 0.05). The percent improvement of glycocalyx thickness (PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P < 0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs + GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: url: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
1841,32823200,Opposite effects of smoking and nicotine intake on cognition.,"Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped effect. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the cognitive tasks. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.",2020,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","['heavy smokers and healthy nonsmokers', 'healthy nonsmokers']","['nicotine', 'nicotine gum', 'placebo']",[],"[{'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0106464,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","[{'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: natalialalmeida@hotmail.com.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Letícia M', 'Initials': 'LM', 'LastName': 'Gonçalves', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'University of Rochester Medical Center, Department of Psychiatry, NY, USA.'}, {'ForeName': 'Isadora C', 'Initials': 'IC', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, NY, USA.'}, {'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: paivatm@gmail.com.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.113357']
1842,32823519,On Performance and Perceived Effort in Trail Runners Using Sensor Control to Generate Biosynchronous Music.,"Music has been shown to be capable of improving runners' performance in treadmill and laboratory-based experiments. This paper evaluates a generative music system, namely HEARTBEATS, designed to create biosignal synchronous music in real-time according to an individual athlete's heartrate or cadence (steps per minute). The tempo, melody, and timbral features of the generated music are modulated according to biosensor input from each runner using a combination of PPG (Photoplethysmography) and GPS (Global Positioning System) from a wearable sensor, synchronized via Bluetooth. We compare the relative performance of athletes listening to music with heartrate and cadence synchronous tempos, across a randomized trial (N = 54) on a trail course with 76 ft of elevation. Participants were instructed to continue until their self-reported perceived effort went beyond an 18 using the Borg rating of perceived exertion. We found that cadence-synchronous music improved performance and decreased perceived effort in male runners. For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested. This work has implications for the future design and implementation of novel portable music systems and in music-assisted coaching.",2020,"For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested.","['male runners', 'Trail Runners Using Sensor Control to Generate Biosynchronous Music']",['athletes listening to music with heartrate and cadence synchronous tempos'],[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}]",[],,0.175,"For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested.","[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'School of Computing, Science & Engineering, the University of Salford, the Crescent, Salford M5 4WT, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fazenda', 'Affiliation': 'School of Computing, Science & Engineering, the University of Salford, the Crescent, Salford M5 4WT, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Williamson', 'Affiliation': 'Lucerne University of Applied Sciences and Arts, 6002 Luzern, Switzerland.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Fazekas', 'Affiliation': 'School of Electronic Engineering and Computer Science, Queen Mary University of London, London E1 4FZ, UK.'}]","Sensors (Basel, Switzerland)",['10.3390/s20164528']
1843,32823850,Tunnel/Pouch versus Coronally Advanced Flap Combined with a Connective Tissue Graft for the Treatment of Maxillary Gingival Recessions: Four-Year Follow-Up of a Randomized Controlled Trial.,"BACKGROUND


The long-term stability after soft tissue graft for covering gingival recession remains a pivotal goal for both patient and periodontist. Therefore, the aim of this study was to compare the four-year outcomes of the coronally advanced flap (CAF) versus the pouch/tunnel (POT) technique, both combined with connective tissue graft (CTG), for gingival recession treatment.
METHODS


Forty patients were initially randomly assigned to the control group (CAF + CTG; N = 20) and the test group (POT + CTG; N = 20). Clinical outcomes included mean root coverage (MRC) and complete root coverage (CRC), gingival thickness (GT), and keratinized tissue (KT) gain. Esthetic outcomes were also analyzed using the pink esthetic score (PES) and patient-reported outcome measures (PROMs). All outcomes initially assessed at six months were extended to four years post-surgery.
RESULTS


No significant differences were observed between the two patient groups in terms of MRC and CRC. At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
CONCLUSIONS


The POT + CTG technique allows for long-term clinical coverage of gingival recessions comparable to that of the CAF + CTG technique, but it potentially improves gingival thickness, keratinized tissue and esthetic results.",2020,"At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
","['Maxillary Gingival Recessions', 'Forty patients']","['POT + CTG', 'Tunnel/Pouch versus Coronally Advanced Flap Combined with a Connective Tissue Graft', 'POT + CTG technique', 'coronally advanced flap (CAF) versus the pouch/tunnel (POT) technique, both combined with connective tissue graft (CTG', 'control group (CAF + CTG']","['tissue texture enhancement', 'MRC and CRC', 'pink esthetic score (PES) and patient-reported outcome measures (PROMs', 'GT and KT gain', 'mean root coverage (MRC) and complete root coverage (CRC), gingival thickness (GT), and keratinized tissue (KT) gain', 'gingival thickness, keratinized tissue and esthetic results']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4319584', 'cui_str': 'Pouch'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",40.0,0.052694,"At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
","[{'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Salem', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Salhi', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Seidel', 'Affiliation': 'Biostatistics and Medico-Economic Information, University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rompen', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9082641']
1844,32772826,Neural Correlates of Sleep Recovery following Melatonin Treatment for Pediatric Concussion: A Randomized Controlled Trial.,"Evidence-based treatments for children with persistent post-concussion symptoms (PPCS) are few and limited. Common PPCS complaints such as sleep disturbance and fatigue could be ameliorated via the supplementation of melatonin, which has significant neuroprotective and anti-inflammatory properties. This study aims to identify neural correlates of melatonin treatment with changes in sleep disturbances and clinical recovery in a pediatric cohort with PPCS. We examined structural and functional neuroimaging (fMRI) in 62 children with PPCS in a randomized, double-blind, placebo-controlled trial of 3 mg or 10 mg of melatonin (NCT01874847). The primary outcome was the total youth self-report Post-Concussion Symptom Inventory (PCSI) score after 28 days of treatment. Secondary outcomes included the change in the sleep domain PCSI score and sleep-wake behavior (assessed using wrist-worn actigraphy). Whole-brain analyses of (1) functional connectivity (FC) of resting-state fMRI, and (2) structural gray matter volumes via voxel-based morphometry were assessed immediately before and after melatonin treatment and compared with placebo to identify neural effects of melatonin treatment. Increased FC of posterior default mode network (DMN) regions with visual, somatosensory, and dorsal networks was detected in the melatonin groups over time. The FC increases also corresponded with reduced wake periods ( r =  -0.27,  p =  0.01). Children who did not recover ( n  = 39) demonstrated significant FC increases within anterior DMN and limbic regions compared with those who did recover (i.e., PCSI scores returned to pre-injury level,  n  = 23) over time, ( p =  0.026). Increases in GM volume within the posterior cingulate cortex were found to correlate with reduced wakefulness after sleep onset ( r =  -0.32 , p =  0.001) and sleep symptom improvement ( r =  0.29 , p =  0.02). Although the melatonin treatment trial was negative and did not result in PPCS recovery (with or without sleep problems), the relationship between melatonin and improvement in sleep parameters was linked to changes in function-structure within and between brain regions interacting with the DMN.",2020,"Children who did not recover (n=39) demonstrated significant FC increases within anterior DMN and limbic regions compared to those that did recover (i.e. PCSI scores returned to pre-injury level n=23) over time, (p=0.026).","['pediatric cohort with PPCS', 'pediatric concussion', 'children with persistent post-concussion symptoms (PPCS', '62 children with PPCS']","['melatonin', 'placebo']","['FC increases within anterior DMN and limbic regions', 'subjective and objective sleep parameters', 'reduced wakefulness after sleep onset', 'total youth self-report Post-Concussion Symptom Inventory (PCSI) score', 'change in the sleep domain PCSI score and sleep-wake behavior (assessed using wrist-worn actigraphy', 'Increased FC of posterior default mode network (DMN) regions with visual, somatosensory and dorsal networks', 'Whole-brain analyses of (i) functional connectivity (FC) of resting-state fMRI, and (ii) structural grey matter (GM) volumes via voxel-based morphometry', 'GM volume', 'FC', 'sleep symptom improvement']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",62.0,0.354803,"Children who did not recover (n=39) demonstrated significant FC increases within anterior DMN and limbic regions compared to those that did recover (i.e. PCSI scores returned to pre-injury level n=23) over time, (p=0.026).","[{'ForeName': 'Kartik K', 'Initials': 'KK', 'LastName': 'Iyer', 'Affiliation': 'Faculty of Medicine, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Zalesky', 'Affiliation': 'Melbourne Neuropsychiatry Centre and Department of Biomedical Engineering, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cocchi', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Clinical Brain Networks Group, Brisbane, Queensland, Australia.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Barlow', 'Affiliation': 'Faculty of Medicine, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of neurotrauma,['10.1089/neu.2020.7200']
1845,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1846,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
1847,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
1848,32788396,Infections in baricitinib clinical trials for patients with active rheumatoid arthritis.,"OBJECTIVES


To evaluate the incidence of infection in patients with active rheumatoid arthritis (RA) treated with baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor.
METHODS


Infections are summarised from an integrated database (8 phase 3/2/1b clinical trials and 1 long-term extension (LTE)) with data to 1 April 2017. The 'all-bari-RA' analysis set included patients who received any baricitinib dose. Placebo comparison was based on six studies with 4 mg and placebo to week 24, including four trials with 2 mg (placebo-controlled set). Dose-response assessment was based on four studies with 2 mg and 4 mg, including LTE data (2-4 mg extended set).
RESULTS


There were 3492 patients who received baricitinib for 7860 patient-years (PY) of exposure (median 2.6 years, maximum 6.1 years). Treatment-emergent infections were higher for baricitinib versus placebo (exposure-adjusted incidence rate (IR)/100 PY: placebo 75.9, 2 mg 84.0 (p not significant), 4 mg 88.4 (p≤0.001)). The IR of serious infection was similar for baricitinib versus placebo and stable over time (all-bari-RA IR 3.0/100 PY). There were 11 cases of tuberculosis (all-bari-RA IR 0.1/100 PY); all occurred with 4 mg in endemic regions. Herpes zoster (HZ) IR/100 PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3). Opportunistic infections, including multidermatomal HZ, were infrequent in the baricitinib programme (all-bari-RA IR 0.5/100 PY).
CONCLUSIONS


Increased rates of treatment-emergent infections including HZ were observed in patients with RA treated with baricitinib, consistent with baricitinib's immunomodulatory mode of action.",2020,"PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3).","['3492 patients who received baricitinib for 7860 patient-years (PY) of exposure (median 2.6 years, maximum 6.1 years', 'patients with active rheumatoid arthritis', 'Infections are summarised from an integrated database (8 phase 3/2/1b clinical trials and 1 long-term extension (LTE)) with data to 1 April 2017', 'patients with active rheumatoid arthritis (RA) treated with']","['placebo', 'placebo (placebo', 'Placebo', 'baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor']",['IR of serious infection'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0266700', 'cui_str': 'Janiceps'}, {'cui': 'C0169661', 'cui_str': 'JAK2 Protein Tyrosine Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.135206,"PY was higher for baricitinib versus placebo (placebo 1.0, 2 mg 3.1 (p not significant), 4 mg 4.3 (p≤0.01)); rates remained elevated and stable over time (all-bari-RA 3.3).","[{'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Winthrop', 'Affiliation': 'Division of Infectious Diseases, Oregon Health and Science University, Portland, Oregon, USA winthrop@ohsu.edu.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Harigai', 'Affiliation': ""Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lindsey', 'Affiliation': 'Ochsner Health Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Byers', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hyslop', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Issa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nishikawa', 'Affiliation': 'Lilly Japan KK, Kobe, Japan.'}, {'ForeName': 'Terence P', 'Initials': 'TP', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Witt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Dickson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Cochin Hospital, APHP and INSERM U-1153, CRESS Paris-Sorbonne, Paris, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216852']
1849,32790196,Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: The DATA-HD HR-pQCT Study.,"In postmenopausal women at high risk of fracture, we previously reported that combined denosumab and high-dose (HD; 40 μg) teriparatide increased spine and hip bone mineral density (BMD) more than combination with standard-dose teriparatide (SD; 20 μg). To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women, who were randomized to receive either teriparatide 20 μg (n = 39) or 40 μg (n = 37) during months 0 to 9 overlapped with denosumab 60 mg s.c. given at months 3 and 9, for a 15-month study duration. The 69 women who completed at least one study visit after baseline are included in this analysis. Over 15 months, increases in total BMD were higher in the HD-group than the SD-group at the distal tibia (5.3% versus 3.4%, p = 0.01) with a similar trend at the distal radius (2.6% versus 1.0%, p = 0.06). At 15 months, cortical porosity remained similar to baseline, with absolute differences of -0.1% and -0.7% at the distal tibia and -0.4% and -0.1% at the distal radius in the HD-group and SD-group, respectively; p = NS for all comparisons. Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% [p < 0.0001 versus baseline] and 1.5% [p < 0.0001 versus baseline] in the HD-group and SD-group, respectively; p = 0.75 for overall group difference). Improvements in trabecular microarchitecture at the distal tibia and estimated strength by micro-finite element analysis at both sites were numerically greater in the HD-group compared with SD-group but not significantly so. Together, these findings suggest that short-term treatment combining denosumab with either high- or standard-dose teriparatide improves HR-pQCT measures of bone density, microstructure, and estimated strength, with greater gains in total bone density observed in the HD-group, which may be of benefit in postmenopausal women with severe osteoporosis. © 2020 American Society for Bone and Mineral Research (ASBMR).",2020,"Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% (P<0.0001 vs. baseline) and 1.5% (P<0.0001 vs. baseline) in the HD-group and SD-group, respectively, P=0.75 for overall group difference).","['69 women who completed at least one study visit after baseline are included in this analysis', 'postmenopausal women with severe osteoporosis', 'postmenopausal women at high risk of fracture']","['teriparatide 20-ug (n=39) or 40-μg (n=37) during months 0-9 overlapped with denosumab 60-mg s.c', 'Combination Denosumab and High-Dose Teriparatide']","['Tibial cortical tissue mineral density', 'total BMD', 'total bone density', 'spine and hip bone mineral density (BMD', 'HR-pQCT measures of bone density, microstructure, and estimated strength', 'cortical porosity', 'Bone Microarchitecture and Estimated Strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0412669', 'cui_str': 'Computerized tomography, bone density study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0080037', 'cui_str': 'Porosity'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",69.0,0.0953027,"Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% (P<0.0001 vs. baseline) and 1.5% (P<0.0001 vs. baseline) in the HD-group and SD-group, respectively, P=0.75 for overall group difference).","[{'ForeName': 'Sabashini K', 'Initials': 'SK', 'LastName': 'Ramchand', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'David', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bruce', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Bouxsein', 'Affiliation': 'Department of Orthopedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Joy N', 'Initials': 'JN', 'LastName': 'Tsai', 'Affiliation': 'Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4161']
1850,32787541,Recruitment best practices of a cardiovascular risk reduction randomised control trial in rural Alaska Native communities.,"Though not native to Alaska, tobacco use is common among Alaska Native people in the Norton Sound region, an area consisting of 16 communities with population size 107 to 3,695. We summarise best practices in recruiting Alaska Native adults who smoke for a randomised controlled tobacco treatment trial. Participants were Alaska Native, 19 years and older, smoking daily, with hypertension and/or high cholesterol, residing in the Norton Sound region of Alaska. Study staff travelled to the remote communities to recruit, typically staying 5 days. Screening and enrolment success was examined by day, season, and staffing level. From June 2015 - December 2018, the study team made 122 trips, screening 1089 individuals and enrolling 314 participants. In the field, days 2-3 (51%) were best for screening, while days 3-4 (53%) had the greatest enrolment. Community size correlated with enrolment (r = 0.83, p <.001). Recruitment was optimised in spring and with multiple staff in the field. Despite challenges (e.g., harsh weather, poor internet connectivity), with active outreach (e.g. tabling in busy areas, attending community events, utilising mixed media, collaborating with clinic staff), the project reached its recruitment goal. Study findings can inform community-based tobacco treatment research trials in remote areas.
ABBREVIATIONS


CVD: Cardiovascular disease; VTC: Video teleconferencing; ANMC: Alaska Native Medical Centre; HEALTHH: Healing and Empowering Alaskan Lives Towards Healthy Hearts; NSHC: Norton Sound Health Corporation; RERB: Research Ethics Review Board.",2020,"Community size correlated with enrolment (r = 0.83, p <.001).","['Participants were Alaska Native, 19\xa0years and older, smoking daily, with hypertension and/or high cholesterol, residing in the Norton Sound region of Alaska', 'Towards Healthy Hearts', 'rural Alaska Native communities', 'Alaska Native people in the Norton Sound region, an area consisting of 16 communities with population size 107 to 3,695', 'From June 2015 - December 2018, the study team made 122 trips, screening 1089 individuals and enrolling 314 participants', 'CVD']",[' NSHC'],[],"[{'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001905', 'cui_str': 'Alaska'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0032683', 'cui_str': 'Population Size'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C1312067', 'cui_str': 'SHC3 protein, human'}]",[],314.0,0.0838417,"Community size correlated with enrolment (r = 0.83, p <.001).","[{'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Knox', 'Affiliation': 'Cardiology Department, Alaska Native Tribal Health Consortium , Anchorage, AK, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Skan', 'Affiliation': 'Cardiology Department, Alaska Native Tribal Health Consortium , Anchorage, AK, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, Division of Cardiology, University of California , San Francisco, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Schnellbaecher', 'Affiliation': 'Cardiology Department, Alaska Native Tribal Health Consortium , Anchorage, AK, USA.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University.'}]",International journal of circumpolar health,['10.1080/22423982.2020.1806639']
1851,32791583,"[Myringotomy or tympanostomy tube insertion, comparison of surgical treatment of adenoid hypertrophy and otitis media with effusion in children].","Objective: The study aimed to observe the difference in postoperative complications and recurrence rates of adenoidectomy plus myringotomy or adenoidectomy plus tympanostomy with tube insertion for children with adenoid hypertrophy combined with otitis media with effusion.  Method: Children 4 to 12 years old with otitis media with effusion combined with adenoid hypertrophy were assigned to receive either adenoidectomy plus myringotomy（group A） or adenoidectomy plus tympanostomy tube insertion（group B）. Pre-and post-operative data was recorded.  Result: There is no ear complication in group A. In group B, some children suffered otorrhea, perforation, blocked tympanic membrane vent and calcification. The recurrence rate of the group A was significantly higher than that of the group B at 3 month after operation. There was no significant difference in recurrence rate between the two groups at 6th month and 12th month after operation.  Conclusion: For children aged 4-12 years with adenoid hypertrophy combined with otitis media with effusion, adenoidectomy plus myringotomy can avoid complications after tympanic tube insertion without increasing the risk of long-term recurrence, we recommend this procedure as the first choice.",2020,There is no ear complication in,"['children with adenoid hypertrophy combined with otitis media with effusion', 'Method: Children 4 to 12 years old with otitis media with effusion combined with adenoid hypertrophy', 'children aged 4-12 years with adenoid hypertrophy combined with otitis media with effusion', 'adenoid hypertrophy and otitis media with effusion in children']","['adenoidectomy plus tympanostomy', 'adenoidectomy plus myringotomy（group', 'adenoidectomy plus myringotomy', 'Myringotomy or tympanostomy tube insertion', 'adenoidectomy plus myringotomy or adenoidectomy plus tympanostomy with tube insertion']","['children suffered otorrhea, perforation, blocked tympanic membrane vent and calcification', 'postoperative complications and recurrence rates', 'recurrence rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029883', 'cui_str': 'Middle ear effusion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C0041450', 'cui_str': 'Tympanostomy Tube Insertion'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0155540', 'cui_str': 'Ear discharge'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0506732,There is no ear complication in,"[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Renzhong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hou', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ""Department of Otolaryngology，Guangzhou Women and Children's Medical Center，Guangzhou，510623，China.""}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.03.005']
1852,32791589,[Effect of sublingual immunotherapy on inflammatory factors and autophagy in patients with allergic rhinitis].,"Objective: To observe the effect of sublingual immunotherapy on the expression of serum inflammatory factors IL-4 and TNF-α as well as autophagy-associated protein LC3 in nasal mucosa in patients with allergic rhinitis（AR）.  Method: Forty patients with AR were randomly divided into SLIT group（ n =20） and control group（ n =20）, the SLIT group received a 2-year intervention with a standardized dust mite vaccine SLIT in combination with conventional drugs, the control group received placebo and conventional drug treatment. Blood samples and inferior turbinate mucosa were collected of both groups before and after the treatment; the clinical symptoms, signs and medication scores of the two groups before and after treatment were analyzed; the expressions of serum IL-4 and TNF-α were detected by ELISA before and after treatment; the expression of autophagy-related protein LC3 was detected by Western blot.  Result: There were no significant differences in the pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression between the SLIT group and the control group（ P >0.05）. After a 2-year treatment, the symptom scores the of SLIT group were significantly improved compared with the control group; serum levels of IL-4 and TNF-α were significantly decreased in the SLIT group; the expression of autophagy-related protein LC3 in the SLIT group was significantly lower than that in the control group, and the difference was statistically significant（ P <0.05）.  Conclusion: SLIT combined with conventional drug therapy is more effective in improving the symptoms of AR patients than conventional drug therapy. SLIT can reduce the inflammation level and expression of autophagy-related proteins in AR patients to a certain extent.",2020,"There were no significant differences in the pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression between the SLIT group and the control group（ P >0.05）.","['Forty patients with AR', 'patients with allergic rhinitis（AR）', 'patients with allergic rhinitis']","['sublingual immunotherapy', 'LC3', 'SLIT group（ n =20） and control group（ n =20）, the SLIT group received a 2-year intervention with a standardized dust mite vaccine SLIT in combination with conventional drugs, the control group received placebo and conventional drug treatment', 'SLIT combined with conventional drug therapy', 'SLIT']","['pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression', 'serum levels of IL-4 and TNF-α', 'expressions of serum IL-4 and TNF-α', 'expression of autophagy-related protein LC3', 'Blood samples and inferior turbinate mucosa', 'inflammatory factors and autophagy', 'clinical symptoms, signs and medication scores', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",40.0,0.0120024,"There were no significant differences in the pre-treatment signs, symptoms, medication scores, age, gender, serum IL-4, TNF-α, and LC3 expression between the SLIT group and the control group（ P >0.05）.","[{'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Otolaryngology，the First Hospital of Changsha，Changsha，410005，China.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology，the First Hospital of Changsha，Changsha，410005，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.03.011']
1853,32791592,[Changes of nasal nitric oxide in the treatment of allergic rhinitis with hydrogen-rich saline lavage of nasal cavity].,"Objective: To observe the effect of hydrogen-rich saline on the concentration of nitric oxide in the nose, and to explore the mechanism of its treatment of allergic rhinitis.  Method: Twenty patients with moderate to severe persistent allergic rhinitis were enrolled in a randomized, double-blind, self-controlled study. The nasal cavity was lavaged with hydrogen-rich normal saline and normal saline, and the nasal nitric oxide（nNO） value was tested weekly.  Result: The test value of nNO was correlated with the diagnosis and curative effect of allergic rhinitis. The difference of nNO test values before and after treatment of the two lavage fluids was statistically significant（ P <0.01）.  Conclusion: Hydrogen-rich saline lavage can cause nNO change in nasal cavity which may be used in the treatment of allergic rhinitis.",2020,The difference of nNO test values before and after treatment of the two lavage fluids was statistically significant（ P <0.01）.  ,"['allergic rhinitis with hydrogen-rich saline lavage of nasal cavity', 'Twenty patients with moderate to severe persistent allergic rhinitis']","['hydrogen-rich normal saline and normal saline', 'hydrogen-rich saline', 'Hydrogen-rich saline lavage']",['nNO test values'],"[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",20.0,0.0507014,The difference of nNO test values before and after treatment of the two lavage fluids was statistically significant（ P <0.01）.  ,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Fan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Otorhinolaryngology，Zhangqiu Chinese Medicine Hospital，Ji'nan.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}, {'ForeName': 'Shaoqing', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Tongji Hospital，Tongji Medical University（Shanghai Tongji Hospital），Shanghai，200065，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.03.014']
1854,32803815,Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial.,"OBJECTIVE


We aimed to determine whether the Managing Cancer and Living Meaningfully (CALM) therapy is superior to a non-manualized supportive psycho-oncological counselling intervention (SPI).
METHODS


Adult patients with advanced cancer and ≥9 points on the PHQ-9 and/or ≥5 points on the DT were randomized to CALM or SPI. We hypothesized that CALM patients would report significantly less depression (primary outcome) on the BDI-II and the PHQ-9 6 months after baseline compared to SPI patients.
RESULTS


From 329 eligible patients, 206 participated (61.2% female; age: M = 57.9 [SD = 11.7]; 84.5% UICC IV stage). Of them, 99 were assigned to CALM and 107 to SPI. Intention-to-treat analyses revealed significantly less depressive symptoms at 6 months than at baseline (P < .001 for BDI-II and PHQ-9), but participants in the CALM and SPI group did not differ in depression severity (BDI-II: P = .62, PHQ-9: P = .998). Group differences on secondary outcomes were statistically not significant either.
CONCLUSIONS


CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.",2020,"CONCLUSIONS


CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.","['age', '329 eligible patients, 206 participated (61.2% female', 'Adult patients with advanced cancer and\u2009≥\u20099 points on the', 'patients with advanced cancer']","['CALM', 'Managing Cancer and Living Meaningfully (CALM) therapy', 'Managing Cancer and Living Meaningfully (CALM) individual psychotherapy', 'PHQ-9']","['depression severity', 'depressive symptoms', 'BDI-II and the PHQ-9 six months']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",329.0,0.224475,"CONCLUSIONS


CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mehnert', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Koranyi', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Philipp', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Scheffold', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Lehmann-Laue', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Engelmann', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Vehling', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Eisenecker', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Oechsle', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schulz-Kindermann', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Rodin', 'Affiliation': 'Department of Supportive Care, 16-724, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Psycho-oncology,['10.1002/pon.5521']
1855,32799362,"A randomized, triple-blind, placebo-controlled, parallel study to evaluate the efficacy of a freshwater marine collagen on skin wrinkles and elasticity.","BACKGROUND


Collagen is the primary component in human skin. With age, there is loss of skin elasticity and collagen, resulting in wrinkle formation and reduction in skin appearance.
AIMS


The objective of this randomized, triple-blind, placebo-controlled study was to evaluate the safety and efficacy of a hydrolyzed marine collagen (Vinh Wellness Collagen, VWC) on aspects of skin health and quality in women between 45 and 60 years of age.
PATIENTS/METHODS


Assessments of skin wrinkles, elasticity, and self-reported appearance were conducted using the VISIA skin analysis system, Cutometer ®  , and Skin Quality Visual Analogue Scale. Outcomes were assessed at weeks 0 (baseline), 6, and 12.
RESULTS


After 12 weeks, participants supplemented with VWC had a significant 35% reduction in wrinkle score (P = .035) from baseline. Participants in the VWC group showed a 24% greater reduction in wrinkles on the right side of the face than those on placebo. A planned subgroup analysis based on age showed women 45-54 years had a significant 20% and 10% improvement in cheek skin elasticity from baseline to week 6 (P = .016) and 12 (P = .022), respectively. At week 12, participants in the VWC group reported greater percentage improvements in overall skin score (9%) and wrinkle (15%), elasticity (23%), hydration (14%), radiance (22%), and firmness (25%) scores vs placebo.
CONCLUSION


Supplementation with VWC was found to be safe and well-tolerated. The results of this study support the use of fish-derived hydrolyzed collagen for the improvement of skin health in an aging population.",2020,Participants in the VWC group showed a 24% greater reduction in wrinkles on the right side of the face than those on placebo.,"['human skin', 'women between 45-60 years of age']","['Freshwater Marine Collagen', 'Placebo', 'fish-derived hydrolyzed collagen', 'hydrolyzed marine collagen (Vinh Wellness Collagen, VWC', 'VWC', 'placebo']","['wrinkle score', 'skin health', 'overall skin score', 'Skin Wrinkles and Elasticity', 'VISIA skin analysis system, Cutometer ®  and Skin Quality Visual Analogue Scale', 'safety and efficacy', 'safe and well-tolerated', 'skin health and quality', 'elasticity', 'cheek skin elasticity']","[{'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0016710', 'cui_str': 'Fresh water'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039152', 'cui_str': 'Analysis, Systems'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0222085', 'cui_str': 'Skin structure of cheek'}]",,0.117762,Participants in the VWC group showed a 24% greater reduction in wrinkles on the right side of the face than those on placebo.,"[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc., London, Ontario, Canada.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Lewis', 'Affiliation': 'KGK Science Inc., London, Ontario, Canada.'}, {'ForeName': 'Nisrine', 'Initials': 'N', 'LastName': 'Zakaria', 'Affiliation': 'KGK Science Inc., London, Ontario, Canada.'}, {'ForeName': 'Tetyana', 'Initials': 'T', 'LastName': 'Pelipyagina', 'Affiliation': 'KGK Science Inc., London, Ontario, Canada.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Guthrie', 'Affiliation': 'KGK Science Inc., London, Ontario, Canada.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13676']
1856,32800078,"Searching for Personalized Medicine for Binge Drinking Smokers: Smoking Cessation Using Varenicline, Nicotine Patch, or Combination Nicotine Replacement Therapy.","OBJECTIVE


Heavy drinking is common among smokers and is associated with especially poor health outcomes. Varenicline may affect mechanisms and clinical outcomes that are relevant for both smoking cessation and alcohol use. The current study examines whether varenicline, relative to nicotine replacement therapy, yields better smoking cessation outcomes among binge drinking smokers.
METHOD


Secondary data analyses of a comparative effectiveness randomized controlled trial of three smoking cessation pharmacotherapies (12 weeks of varenicline, nicotine patch, or nicotine patch and lozenge) paired with six counseling sessions were conducted. Adult daily cigarette smokers (N = 1,078, 52% female) reported patterns of alcohol use, cigarette craving, and alcohol-related cigarette craving at baseline and over 4 weeks after quitting. Smoking cessation outcome was 7-day biochemically confirmed point-prevalence abstinence.
RESULTS


Binge drinkers had higher relapse rates than moderate drinkers at 4-week post-target quit day but not at the end of treatment or long-term follow up (12 and 26 weeks). Varenicline did not yield superior smoking cessation outcomes among binge drinkers, nor did it affect alcohol use early in the quit attempt. Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
CONCLUSIONS


Varenicline did not yield higher smoking abstinence rates or reduce alcohol use among binge drinkers. Varenicline did reduce alcohol-related cigarette craving but this did not translate to meaningful differences in smoking abstinence. Varenicline's effects on smoking abstinence do not appear to vary significantly as a function of drinking status.",2020,"Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
","['Binge Drinking Smokers', 'Adult daily cigarette smokers (N = 1,078, 52% female) reported patterns of alcohol use, cigarette craving, and alcohol-related cigarette craving at baseline and over 4 weeks after quitting', 'binge drinking smokers']","['Varenicline, Nicotine Patch, or Combination Nicotine Replacement Therapy', 'smoking cessation pharmacotherapies', 'Varenicline', 'varenicline', 'nicotine replacement therapy', 'varenicline, nicotine patch, or nicotine patch and lozenge) paired with six counseling sessions']","['alcohol-related cigarette craving', 'smoking abstinence', 'relapse rates', 'alcohol-related cigarette craving and overall cigarette craving', 'Smoking cessation outcome', 'smoking abstinence rates']","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.0099727,"Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
","[{'ForeName': 'Jesse T', 'Initials': 'JT', 'LastName': 'Kaye', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}, {'ForeName': 'Adrienne L', 'Initials': 'AL', 'LastName': 'Johnson', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}]",Journal of studies on alcohol and drugs,[]
1857,32800081,"Effects of Alcohol, Condom Request Style, and State Anger on Men's Condom Use Resistance.","OBJECTIVE


The purpose of this study was to examine the distal predictors (alcohol expectancies, adversarial heterosexual beliefs) and proximal predictors (alcohol intoxication, partner's condom use request style, state anger) of young men's condom use resistance (CUR).
METHOD


Young, male, non-problem drinking, inconsistent condom users (N = 297) completed an alcohol administration experiment. After completing background measures, participants were randomly assigned to receive a control or alcoholic beverage (target peak breath alcohol concentration = .08%). They then read a randomly assigned hypothetical sexual scenario in which their female partner requested to use a condom either indirectly, directly, or insistently. Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
RESULTS


Path analyses demonstrated that alcohol intoxication directly predicted noncoercive CUR intentions. In addition, a moderated mediation pathway was found such that, relative to sober participants, intoxicated men's sexual aggression-related alcohol expectancies were positively associated with their state anger in response to the partner's condom use request. This increased anger was related to stronger noncoercive CUR intentions. Adversarial heterosexual beliefs both directly and indirectly predicted coercive and noncoercive CUR intentions.
CONCLUSIONS


Path analysis demonstrated that alcohol intoxication increased intentions to resist condom use through noncoercive tactics. In addition, men's misogynistic attitudes and alcohol intoxication were associated with greater feelings of anger, which predicted stronger coercive and noncoercive CUR intentions.",2020,"Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
","['Young, male, non-problem drinking, inconsistent condom users (N = 297) completed an alcohol administration experiment']","['control or alcoholic beverage', 'Alcohol, Condom Request Style, and State Anger']","[""distal predictors (alcohol expectancies, adversarial heterosexual beliefs) and proximal predictors (alcohol intoxication, partner's condom use request style, state anger) of young men's condom use resistance (CUR"", 'noncoercive CUR intentions', 'sexual aggression-related alcohol expectancies', ""Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0233953', 'cui_str': 'Sexual aggression'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",297.0,0.0222601,"Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cue Davis', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Kirwan', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Rhiana', 'Initials': 'R', 'LastName': 'Wegner', 'Affiliation': 'University of Massachusetts, Boston, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Neilson', 'Affiliation': 'Department of Psychology, Morehead State University, Morehead, Kentucky.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Stappenbeck', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia.'}]",Journal of studies on alcohol and drugs,[]
1858,32800099,"Effect of mammographic screening from age 40 years on breast cancer mortality (UK Age trial): final results of a randomised, controlled trial.","BACKGROUND


The appropriate age range for breast cancer screening remains a matter of debate. We aimed to estimate the effect of mammographic screening at ages 40-48 years on breast cancer mortality.
METHODS


We did a randomised, controlled trial involving 23 breast screening units across Great Britain. We randomly assigned women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen at approximately age 50 years (control group). Women in the intervention group were recruited by postal invitation. Women in the control group were unaware of the study. The primary endpoint was mortality from breast cancers (with breast cancer coded as the underlying cause of death) diagnosed during the intervention period, before the participant's first NHSBSP screen. To study the timing of the mortality effect, we analysed the results in different follow-up periods. Women were included in the primary comparison regardless of compliance with randomisation status (intention-to-treat analysis). This Article reports on long-term follow-up analysis. The trial is registered with the ISRCTN registry, ISRCTN24647151.
FINDINGS


160 921 women were recruited between Oct 14, 1990, and Sept 24, 1997. 53 883 women (33·5%) were randomly assigned to the intervention group and 106 953 (66·5%) to the control group. Between randomisation and Feb 28, 2017, women were followed up for a median of 22·8 years (IQR 21·8-24·0). We observed a significant reduction in breast cancer mortality at 10 years of follow-up, with 83 breast cancer deaths in the intervention group versus 219 in the control group (relative rate [RR] 0·75 [95% CI 0·58-0·97]; p=0·029). No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
INTERPRETATION


Yearly mammography before age 50 years, commencing at age 40 or 41 years, was associated with a relative reduction in breast cancer mortality, which was attenuated after 10 years, although the absolute reduction remained constant. Reducing the lower age limit for screening from 50 to 40 years could potentially reduce breast cancer mortality.
FUNDING


National Institute for Health Research Health Technology Assessment programme.",2020,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","['from age 40 years on breast cancer mortality (UK Age trial', '160\u2008921 women were recruited between Oct 14, 1990, and Sept 24, 1997', '23 breast screening units across Great Britain', 'at ages 40-48 years on breast cancer mortality', 'women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to', '53\u2008883 women (33·5']","['mammographic screening', 'standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen']","['breast cancer mortality', 'mortality from breast cancers (with breast cancer coded as the underlying cause of death', 'mortality effect']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456586', 'cui_str': 'Calendar year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",23.0,0.112667,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","[{'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK. Electronic address: s.w.duffy@qmul.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cuckle', 'Affiliation': 'Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'American Cancer Society, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Division of Cancer Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Blyuss', 'Affiliation': 'School of Physics, Astronomy, and Mathematics, University of Hertfordshire, Hatfield, UK; Department of Paediatrics and Paediatric Infectious Diseases, Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Ian O', 'Initials': 'IO', 'LastName': 'Ellis', 'Affiliation': 'Division of Cancer and Stem Cells, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myles', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30398-3']
1859,32828927,"Virtual training leads to physical, cognitive and neural benefits in healthy adults.","Physical activity, such as high-intensity intermittent aerobic exercise (HIE), can improve executive functions. Although performing strength or aerobic training might be problematic or not feasible for someone. An experimental situation where there is no actual movement, but the body shows physiological reactions, is during the illusion through immersive virtual reality (IVR). We aimed to demonstrate whether a virtual HIE-based intervention (vHIE) performed exclusively by the own virtual body has physical, cognitive, and neural benefits on the real body. 45 healthy young adults (cross-over design) experienced HIE training in IVR (i.e., the virtual body performed eight sets of 30 s of running followed by 30 s of slow walking, while the subject is completely still) in two random-ordered conditions (administered in two sessions one week apart): the virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP). During the vHIE, we recorded the heart rate and subjective questionnaires to confirm the effectiveness of the illusion; before and after vHIE, we measured cortical hemodynamic changes in the participants' left dorsolateral prefrontal cortex (lDLPFC) using the fNIRS device during the Stroop task to test our main hypothesis. Preliminary, we confirmed that the illusion was effective: during the vHIE in 1PP, subjects' heart rate increased coherently with the virtual movements, and they reported subjective feelings of ownership and agency. Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently. Clinically, these results might be exploited to train cognition and body simultaneously. Theoretically, we proved that the sense of body ownership and agency can affect other parameters, even in the absence of actual movements.",2020,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","['healthy adults', '45 healthy young adults']","['strength or aerobic training', 'virtual HIE-based intervention (vHIE', 'Virtual training', 'Physical activity, such as high-intensity intermittent aerobic exercise (HIE', 'virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP', 'HIE training']","['heart rate and subjective questionnaires', 'lDLPFC activity', 'heart rate']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",45.0,0.0142803,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","[{'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Burin', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan. Electronic address: burin.dalila.c3@tohoku.ac.jp.'}, {'ForeName': 'Yingxu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Noriki', 'Initials': 'N', 'LastName': 'Yamaya', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117297']
1860,32789809,Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects.,"INTRODUCTION


Pegfilgrastim-cbqv was developed as a biosimilar of pegfilgrastim, a pegylated form of recombinant human granulocyte colony-stimulating factor approved for decreasing febrile neutropenia-associated infection in patients receiving myelosuppressive drugs. This multicenter, randomized, single-blind, partial-reference-replicated, three-sequence crossover study assessed pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects.
METHODS


One hundred twenty-two subjects were randomized to one of three treatment sequences; each included one dose of pegfilgrastim-cbqv and two doses of pegfilgrastim separated by ≥ 28 days. The primary pharmacokinetic end points were area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ). The primary pharmacodynamic end points were maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ). Pharmacokinetic and pharmacodynamic bioequivalences were demonstrated if the 90% CI for the geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim was within 80-125% for the primary end points.
RESULTS


Pharmacokinetic bioequivalence criteria were met for C max  (GMR 105.0; 90% CI 95.5-115.4) and AUC 0-∞  (GMR 97.5; 90% CI 88.6-107.2). Pharmacodynamic bioequivalence criteria were met for ANC max  (GMR 99.6; 90% CI 96.2-103.2) and ANC AUC 0-last  (GMR 96.7; 90% CI 92.2-101.4). Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively. Investigators found no drug-related serious adverse events.
CONCLUSION


This study established pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv to pegfilgrastim. The treatments displayed similar safety profiles, including immunogenicity, with no unexpected safety findings.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov, NCT02650973, February 2016.",2020,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","['One hundred twenty-two subjects', 'patients receiving myelosuppressive drugs', 'healthy subjects', 'Healthy Subjects']","['pegfilgrastim-cbqv and pegfilgrastim', 'pegfilgrastim-cbqv and two doses of pegfilgrastim separated by\u2009≥', 'recombinant human granulocyte colony-stimulating factor', 'Pegfilgrastim-cbqv and Pegfilgrastim', 'pegfilgrastim-cbqv to pegfilgrastim']","['geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim', 'area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ', 'Adverse events', 'pharmacokinetic and pharmacodynamic bioequivalence', 'Pharmacokinetic and pharmacodynamic bioequivalences', 'Pharmacokinetic and Pharmacodynamic Equivalence', 'maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",122.0,0.0612766,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Finck', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA. bfinck@coherus.com.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Civoli', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hodge', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': ""O'Kelly"", 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vexler', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01459-y']
1861,32784945,Tensile Strength and Failure Types of Direct and Indirect Resin Composite Copings for Perio-Overdentures Luted Using Different Adhesive Cementation Modalities.,"Perio-overdenture design helps to reduce periodontal diseases and secondary caries on abutment teeth. Composite copings can be cemented adhesively to the abutment teeth with different techniques. In this study, direct/indirect resin composite copings for perio-overdentures, luted using different adhesive cementation modalities were compared. Human teeth (N = 40) were prepared to receive spherical attachment copings and randomly divided into four groups: (1) resin-composite copings bonded directly (DC), (2) composite copings made indirectly, luted with dual-polymerized resin cement (ICV), (3) composite copings made indirectly, bonded with resin composite (ICT), (4) composite copings made indirectly, bonded with resin composite after the immediate dentin sealing method (IDS). Specimens were tested for tensile failure and one-way ANOVA (alpha = 0.05) was performed and the two-parameter Weibull modulus, scale ( m ) and shape ( 0 ) were calculated. Mean tensile load (N) was significantly higher for Group IDS (238 ± 81) than for the other groups (144 ± 53-184 ± 46) ( p  < 0.05). Group IDS (0.54 ± 0.25 mm) showed significantly higher deformation (mm) than other groups (0.2 ± 0.1-0.32 ± 0.15) ( p  < 0.05). Weibull distribution presented lower shape ( 0 ) for DC (3.33) compared to other groups (3.57-4.99). Cohesive coping failures were more frequent in Group IDS (60%) and mixed failures in other groups (40-60%). In conclusion, IDS copings could be preferred over other fabrication and adhesion modalities.",2020,Mean tensile load (N) was significantly higher for Group IDS (238 ± 81) than for the other groups (144 ± 53-184 ± 46) ( p  < 0.05).,"['Human teeth (N = 40', 'Perio-Overdentures Luted']","['resin-composite copings bonded directly (DC), (2) composite copings made indirectly, luted with dual-polymerized resin cement (ICV), (3) composite copings made indirectly, bonded with resin composite (ICT), (4) composite copings made indirectly, bonded with resin composite after the immediate dentin sealing method (IDS', 'spherical attachment copings']","['Cohesive coping failures', 'Mean tensile load (N']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0293639,Mean tensile load (N) was significantly higher for Group IDS (238 ± 81) than for the other groups (144 ± 53-184 ± 46) ( p  < 0.05).,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Cesca', 'Affiliation': 'Laboratory of Physiology and Biomechanics of the Masticatory System, Clinic for Masticatory Disorders, Center for Dental and Oral Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Colombo', 'Affiliation': 'Laboratory of Physiology and Biomechanics of the Masticatory System, Clinic for Masticatory Disorders, Center for Dental and Oral Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Ernst', 'Affiliation': 'Clinic for Reconstructive Dentistry, Division of Dental Biomaterials, Center for Dental and Oral Medicine, University of Zürich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Luigi Maria', 'Initials': 'LM', 'LastName': 'Gallo', 'Affiliation': 'Laboratory of Physiology and Biomechanics of the Masticatory System, Clinic for Masticatory Disorders, Center for Dental and Oral Medicine, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'Clinic for Reconstructive Dentistry, Division of Dental Biomaterials, Center for Dental and Oral Medicine, University of Zürich, 8032 Zurich, Switzerland.'}]","Materials (Basel, Switzerland)",['10.3390/ma13163517']
1862,32787819,Correction to: Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],[],[],[],[],[],,0.0793028,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Frank', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Garrood', 'Affiliation': ""Department of Rheumatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""School of Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMC psychiatry,['10.1186/s12888-020-02811-w']
1863,32790904,Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial.,"OBJECTIVES


This randomized open-label trial compared the efficacy and tolerability of vortioxetine (15 mg/daily) with different antidepressants in the treatment of patients with burning mouth syndrome (BMS).
METHODS


One and hundred fifty BMS patients were randomized into five groups and treated with either vortioxetine, paroxetine (20 mg/daily), sertraline (50 mg/daily), escitalopram (10 mg/daily) or duloxetine (60 mg/daily). The Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A), and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E) were performed at baseline and after 2, 4, 6, and 12 months of treatment. Any adverse events (AEs) were tabulated for each group. Descriptive statistics, including the Kruskal-Wallis non-parametric test and the Friedman non-parametric test for median comparisons between different times, were used.
RESULTS


All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI-I, and CGI-E scores in the long-term (p < .001). However, the response rate of the vortioxetine group showed a significant reduction after six months. The medians, after 6 months, were as follows: VAS 0.0; T-PRI 2.0; HAM-A 7.0; HAM-D 7.0; CGI-I 1.0; and CGI-E 1.0 with a lower incidence of AEs (p < .019).
CONCLUSION


Vortioxetine was efficacious with a shorter latency of action and fewer AEs compared with other ADs.",2020,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","['patients with Burning Mouth Syndrome (BMS', '150 BMS patients', 'Burning Mouth Syndrome']","['vortioxetine', 'vortioxetine, paroxetine', 'sertraline', 'Vortioxetine', 'escitalopram (10 mg/ daily) or duloxetine']","['I and CGI-E scores', 'Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E', 'VAS, T-PRI, HAM-A, HAM-D, CGI', 'efficacy and tolerability', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",150.0,0.0555323,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Adamo', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pecoraro', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Coppola', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calabria', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aria', 'Affiliation': 'Department of Economics and Statistics, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Davide Mignogna', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}]",Oral diseases,['10.1111/odi.13602']
1864,32791643,[Efficacy of high dose glucocorticoid in the salvage treatment of sudden deafness].,"Objective: To observe the efficacy and safety of high dose dexamethasone injection in the tympanic cavity in the patients with sudden and severe deafness who failed conventional treatment.  Method: A total of 43 patients with unilateral sudden and severe deafness were recruited in this study. All patients were not cured with conventional comprehensive treatment in the department of otology. They were divided into two groups: 21cases were treated with high dose dexamethasone injection into the tympanic cavity by ventilation tube （dexamethasone group）, while routine treatment was continued in 22 cases （conventional control group）. Each patient underwent a hearing test before treatment, the hearing thresholds of 6 frequencies （0.25, 0.5, 1.0, 2.0, 4.0, 8.0 kHz） were recorded. After one week of treatment, the above-mentioned six frequencies were re-recorded. A decrease of the pure tone threshold average （PTA） more than 15 dB was set for effective.  Result: After 1 week treatment, comparison of the PTA value before and after treatment in dexamethasone group（ t =11.749） and in conventional control group （ t =7.364），comparison of the PTA value of the two groups （ t =-2.628），comparison of the PTA value of hearing improvement between the two groups （ t =2.717）,the differences were statistically significant（ P <0.01 or 0.05）. Sixteen cases in dexamethasone group were effective, the effective rate was 76.2%;10 cases in conventional control group was effective, the effective rate was 45.5%,the difference of the two curative effects was statistically significant（ χ² =3.058, P <0.05）. Eighteen patients in dexamethasone group had vertigo before treatment. The patients were followed up for 6 months after treatment. The vertigo disappeared or decreased in 14 cases, the improve rate is 77.8%.17 patients in the conventional control group had vertigo before treatment, the patients were followed up for 6 months after treatment, the vertigo disappeared or decreased in 6 cases, the improve rate is 35.3%,the difference was statistically significant（ P =0.018）.  Conclusion: High dose dexamethasone injection into the tympanic cavity is more effective than conventional therapy in the salvage treatment of sudden and severe deafness, and it is helpful to improve vertigo.",2020,"Sixteen cases in dexamethasone group were effective, the effective rate was 76.2%;10 cases in conventional control group was effective, the effective rate was 45.5%,the difference of the two curative effects was statistically significant（ χ² =3.058, P <0.05）.","['All patients were not cured with conventional comprehensive treatment in the department of otology', '43 patients with unilateral sudden and severe deafness', 'sudden deafness', 'patients with sudden and severe deafness who failed conventional treatment', 'Eighteen patients in']","['dexamethasone', 'glucocorticoid', 'dexamethasone injection into the tympanic cavity by ventilation tube （dexamethasone', 'dexamethasone injection']","['vertigo', 'vertigo disappeared', 'efficacy and safety', 'hearing improvement', 'effective rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086746', 'cui_str': 'Otology'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C3874334', 'cui_str': 'Severe hearing loss'}, {'cui': 'C1148477', 'cui_str': 'Sudden Deafness'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}, {'cui': 'C0242255', 'cui_str': 'Tympanic cavity structure'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",43.0,0.0218731,"Sixteen cases in dexamethasone group were effective, the effective rate was 76.2%;10 cases in conventional control group was effective, the effective rate was 45.5%,the difference of the two curative effects was statistically significant（ χ² =3.058, P <0.05）.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology，Affiliated Hospital of Hebei University.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Luo', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，the Second Hospital of Baoding，Baoding，071000，China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology，Baoding Xushui District Hospital of Traditional Chinese Medicine.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.07.016']
1865,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
1866,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
1867,32798558,Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages.,"AIMS


We aimed to evaluate the effect of Dexmedetomidine (Dex) on immunology function of macrophages and inflammatory reactions in non-ventilated lung tissues from both humans and rats.
MAIN METHODS


Patients scheduled for lung lobectomy were randomly assigned to traditional anesthesia group or Dex anesthesia group, 15 subjects in each group. CD68, CD86 and CD206 were used to mark activate and polarized macrophages using immunofluorescence staining in human lung tissues. Sprague-Dawley rats were used to set lung injury model and randomly divided into Control group, one-lung ventilation group (CLI group) and CLI + Dex group. Lung tissues and bronchoalveolar lavage fluid (BALF) from non-ventilated lungs were collected. The acquired lung tissues were subjected to hematoxylin-eosin (H&E) staining and the inflammatory cells in BALF were calculated. Levels of cytokines and chemokines were detected by enzyme-linked immunosorbent assays (ELISA).
KEY FINDINGS


Results from humans showed that anesthesia with Dex decreased the number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1) in human lung. Results from rats demonstrated that treatment with Dex reversed the increased inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif) ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
SIGNIFICANCE


This study showed that Dex modulated the activation and immunological function of macrophages in non-ventilated lung and revealed a protective role in collapsed lung injury.",2020,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","['Patients scheduled for lung lobectomy', 'non-ventilated lung tissues from both humans and rats']","['traditional anesthesia group or Dex anesthesia', 'Dexmedetomidine (Dex', 'Control group, one-lung ventilation group (CLI group) and CLI\u202f+\u202fDex group', 'Dexmedetomidine', 'Dex']","['inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif', 'Levels of cytokines and chemokines', 'immunology function of macrophages and inflammatory reactions', 'Lung tissues and bronchoalveolar lavage fluid (BALF', 'number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1', 'anti-inflammatory cytokine interleukin-10 (IL-10']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C1453673', 'cui_str': 'CLU protein, human'}]","[{'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",15.0,0.0272658,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","[{'ForeName': 'Qiying', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: shenqiying-yy@163.com.'}, {'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Department of Anesthesiology, the Fourth Affiliated Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Life sciences,['10.1016/j.lfs.2020.118249']
1868,32799365,Randomized clinical trial comparing PEG-based synthetic to porcine-derived collagen membrane in the preservation of alveolar bone following tooth extraction in anterior maxilla.,"OBJECTIVES


The objective of this randomized controlled trial was to compare alveolar ridge preservation using a bone substitute material and covered with a synthetic or porcine collagen membrane.
MATERIALS AND METHODS


Thirty-two sockets in the aesthetic maxillary region of 30 patients were randomized into two groups. Randomization was stratified according to bone wall defect. Flapless technique was used, and sockets were grafted with bi-phasic calcium phosphate particulate bone substitute and covered by synthetic polyethylene glycol (PEG; test group) or porcine-derived collagen membrane (CM; control group). No primary closure was attempted. A cone beam computed tomography (CBCT) scan was performed immediately after the surgical procedure and repeated 22 weeks later. OnDemand3D was used to superimpose scan images and assess changes. The mean vertical and horizontal percentage bone loss were calculated and implants placed after 6 months with or without additional augmentation.
RESULTS


There were no baseline differences between groups or dropouts. The mean percentage loss at the labial plate and at the coronal part of the sockets was statistically significantly lower in the test group compared with controls (-2.86% [SD = 13.48] versus 7.42% [SD = 11.95]; 13.45% [SD = 11.97] versus 28.59% [SD = 16.97]). Implants were placed after 6 months, and there was no difference in need for further augmentation between PEG (n = 5) or CM (n = 4).
CONCLUSION


Sites treated with PEG membrane showed less percentage loss in horizontal and vertical measurements in this trial.",2020,"Implants were placed after 6 months and there was no difference in need for further augmentation between PEG(n=5) or CM(n=4).
","['anterior maxilla', 'Thirty-two sockets in the esthetic maxillary region of 30 patients']","['cone beam computed tomography (CBCT) scan', 'peg-based synthetic to porcine-derived collagen membrane', 'bone substitute material and covered with a synthetic or porcine collagen membrane', 'Flapless technique was used and sockets were grafted with bi-phasic calcium phosphate particulate bone substitute and covered by synthetic poly-ethylene glycol (PEG; test group) or porcine derived collagen membrane (CM; control group', 'PEG membrane']","['mean percentage loss', 'mean vertical and horizontal percentage bone loss']","[{'cui': 'C0459697', 'cui_str': 'Anterior segment of maxilla'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0015083', 'cui_str': 'ethylene glycol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",30.0,0.0841553,"Implants were placed after 6 months and there was no difference in need for further augmentation between PEG(n=5) or CM(n=4).
","[{'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Shahdad', 'Affiliation': 'Barts Health NHS Trust, The Royal London Dental Hospital, London, UK.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Gamble', 'Affiliation': 'Barts Health NHS Trust, The Royal London Dental Hospital, London, UK.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Matani', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gambôa', 'Affiliation': 'University of Bristol, School of Oral and Dental Sciences, Bristol, UK.'}]",Clinical oral implants research,['10.1111/clr.13648']
1869,32799649,A Collaborative and Cognitive-based Intervention for Young People with Cerebral Palsy.,"BACKGROUND.


Evidence-based approaches to improve function in individuals with cerebral palsy are needed.
PURPOSE.


To investigate the effectiveness of the Cognitive Orientation to daily Occupational Performance approach™ (CO-OP) to improve performance on self-chosen, functional goals as compared to traditional occupational therapy for cerebral palsy.
METHOD.


Crossover design with 12 participants, aged 6-15 years, randomly assigned to CO-OP and traditional intervention groups, followed by crossover and a 3-month follow-up. The participants identified three occupation-based goals for CO-OP and each group received ten 45-minutes intervention twice weekly in clinical context. Occupational performance, manual dexterity and Gross Motor Function Measures were analysed using generalized estimating equations.
FINDINGS.


There were clinical and statistically significant improvements in functional goals following CO-OP and not traditional therapy. There were gains in dexterity but not in gross motor skills.
IMPLICATIONS.


CO-OP was effective to improve functional performance in young people with cerebral palsy and should be more utilized.",2020,"To investigate the effectiveness of the Cognitive Orientation to daily Occupational Performance approach™ (CO-OP) to improve performance on self-chosen, functional goals as compared to traditional occupational therapy for cerebral palsy.
","['12 participants, aged 6-15 years', 'Young People with Cerebral Palsy', 'individuals with cerebral palsy', 'young people with cerebral palsy']","['CO-OP and traditional intervention', 'Collaborative and Cognitive-based Intervention', 'CO-OP', 'Cognitive Orientation to daily Occupational Performance approach™ (CO-OP']","['functional performance', 'Occupational performance, manual dexterity and Gross Motor Function Measures', 'functional goals', 'gains in dexterity']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0186376,"To investigate the effectiveness of the Cognitive Orientation to daily Occupational Performance approach™ (CO-OP) to improve performance on self-chosen, functional goals as compared to traditional occupational therapy for cerebral palsy.
","[{'ForeName': 'Larissa K', 'Initials': 'LK', 'LastName': 'Sousa', 'Affiliation': ''}, {'ForeName': 'Marina Brito', 'Initials': 'MB', 'LastName': 'Brandão', 'Affiliation': ''}, {'ForeName': 'Clare M', 'Initials': 'CM', 'LastName': 'Curtin', 'Affiliation': ''}, {'ForeName': 'Livia C', 'Initials': 'LC', 'LastName': 'Magalhães', 'Affiliation': ''}]",Canadian journal of occupational therapy. Revue canadienne d'ergotherapie,['10.1177/0008417420946608']
1870,32808931,Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial.,"BACKGROUND


To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies.
OBJECTIVE


The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users.
METHODS


We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses.
RESULTS


The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients.
CONCLUSIONS


This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
TRIAL REGISTRATION


Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18632.",2020,"Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses.
","['88 patients', 'Patients With Chronic Pain', '158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers']","['Mobile Health App (AGRIPPA', 'AGRIPPA']","['pain disability', 'time of pain-related disability', 'health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",158.0,0.24399,"Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Elbers', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Pool', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Harriët', 'Initials': 'H', 'LastName': 'Wittink', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Albère', 'Initials': 'A', 'LastName': 'Köke', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Health, Life Sciences and Medicine, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Scheffer', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Smeets', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Health, Life Sciences and Medicine, Maastricht University, Maastricht, Netherlands.'}]",JMIR research protocols,['10.2196/18632']
1871,32810146,"Effectiveness of a culturally appropriate intervention to prevent intimate partner violence and HIV transmission among men, women, and couples in rural Ethiopia: Findings from a cluster-randomized controlled trial.","BACKGROUND


Intimate partner violence (IPV) is associated with increased HIV risk and other adverse health and psychosocial outcomes. We assessed the impact of Unite for a Better Life (UBL), a gender-transformative, participatory intervention delivered to men, women, and couples in Ethiopia in the context of the coffee ceremony, a traditional community-based discussion forum.
METHODS AND FINDINGS


Villages (n = 64) in 4 Ethiopian districts were randomly allocated to control, men's UBL, women's UBL, or couples' UBL, and approximately 106 households per village were randomly selected for inclusion in the trial. The intervention included 14 sessions delivered twice weekly by trained facilitators; control arm households were offered a short IPV educational session. Primary outcomes were women's experience of past-year physical or sexual IPV 24 months postintervention. Secondary outcomes included male perpetration of past-year physical or sexual IPV, comprehensive HIV knowledge, and condom use at last intercourse. Additional prespecified outcomes included experience and perpetration of past-year physical and/or sexual IPV and emotional IPV, HIV/AIDs knowledge and behaviors, decision-making, and gender norms. An intention-to-treat (ITT) analysis was conducted, evaluating 6,770 households surveyed at baseline in 2014-2015 (1,680 households, 16 clusters in control; 1,692 households, 16 clusters in couples' UBL; 1,707 households, 16 clusters in women's UBL; 1,691 households, 16 clusters in men's UBL). Follow-up data were available from 88% of baseline respondents and 87% of baseline spouses surveyed in 2017-2018. Results from both unadjusted and adjusted specifications are reported, the latter adjusting for age, education level, marriage length, polygamy, socioeconomic status, and months between intervention and endline. For primary outcomes, there was no effect of any UBL intervention compared to control on women's past-year experience of physical (couples' UBL arm adjusted odds ratio [AOR] = 1.00, 95% confidence interval [CI]: 0.77-1.30, p = 0.973; women's UBL arm AOR = 1.11, 95% CI 0.87-1.42, p = 0.414; men's UBL arm AOR = 1.02, 95% CI: 0.81-1.28, p = 0.865) or sexual IPV (couples' UBL arm AOR = 0.86, 95% CI: 0.62-1.20, p = 0.378; women's UBL arm AOR = 1.15, 95% CI: 0.89-1.50; p = 0.291; men's UBL arm AOR = 0.80, 95% CI: 0.63-1.01, p = 0.062). For the secondary outcomes, only the men's UBL intervention significantly reduced male perpetration of past-year sexual IPV (AOR: 0.73; 95% CI: 0.56-0.94, p = 0.014), and no intervention reduced perpetration of past-year physical IPV. Among women, the couples' UBL intervention significantly improved comprehensive HIV knowledge, and both couples' and women's UBL significantly increased reported condom use at last intercourse. Among additional outcomes of interest, the men's UBL intervention was associated with a significant reduction in women's experience of past-year physical and/or sexual IPV (AOR = 0.81, 95% CI: 0.66-0.99, p = 0.036) and men's perpetration of physical and/or sexual IPV (AOR = 0.78; 95% CI: 0.62-0.98, p = 0.037). UBL delivered to men and couples was associated with a significant reduction in HIV risk behaviors and more equitable intrahousehold decision-making and household task-sharing. The primary limitation is reliance on self-reported data.
CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women. We found evidence of decreased sexual IPV with men's UBL across men's and women's reports and of increased HIV knowledge and condom use at last intercourse among women. The men's UBL intervention could help accelerate progress towards gender equality and combating HIV/AIDS.
TRIAL REGISTRATION


The trial was prospectively registered at clinicaltrials.gov (NCT02311699) and in the American Economic Association registry (AEARCTR-0000211).",2020,"CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women.","[""6,770 households surveyed at baseline in 2014-2015 (1,680 households, 16 clusters in control; 1,692 households, 16 clusters in couples' UBL; 1,707 households, 16 clusters in women's UBL; 1,691 households, 16 clusters in men's UBL"", 'men, women, and couples in Ethiopia in the context of the coffee ceremony, a traditional community-based discussion forum', 'Intimate partner violence (IPV', 'men, women, and couples in rural Ethiopia', ""Villages (n = 64) in 4 Ethiopian districts were randomly allocated to control, men's UBL, women's UBL, or couples' UBL, and approximately 106 households per village""]","['culturally appropriate intervention', 'UBL', '14 sessions delivered twice weekly by trained facilitators; control arm households were offered a short IPV educational session', 'UBL intervention']","[""women's experience of past-year physical or sexual IPV 24 months postintervention"", 'sexual IPV', 'male perpetration of past-year sexual IPV', ""women's experience of past-year physical and/or sexual IPV"", 'intimate partner violence and HIV transmission', ""comprehensive HIV knowledge, and both couples' and women's UBL"", 'experience and perpetration of past-year physical and/or sexual IPV and emotional IPV, HIV/AIDs knowledge and behaviors, decision-making, and gender norms', 'HIV risk behaviors', ""women's past-year experience of physical"", ""men's perpetration of physical and/or sexual IPV"", 'male perpetration of past-year physical or sexual IPV, comprehensive HIV knowledge, and condom use at last intercourse']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",6770.0,0.220406,"CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women.","[{'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Abdul Latif Jameel Poverty Action Lab, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leight', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Verani', 'Affiliation': 'CARE, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Tewolde', 'Affiliation': 'EngenderHealth, Addis Ababa, Ethiopia.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'Ethiopian Public Health Association, Addis Ababa, Ethiopia.'}]",PLoS medicine,['10.1371/journal.pmed.1003274']
1872,32812886,Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge-Rehabilitation Gap: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Home-based cardiac rehabilitations (CRs) with digital technologies have been researched and implemented to replace, augment, and complement traditional center-based CR in recent years with considerable success. One problem that technology-enhanced home-based CR can potentially address is the gap between cardiac interventions and formal CR programs. In the Netherlands and some other countries (eg, Australia), patients after cardiac interventions stay at home for 3-4 weeks without much support from their physicians, and often engage in very little physical activity (PA). A home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, potentially increasing the uptake rate of those programs.
OBJECTIVE


In a randomized controlled trial (RCT), we will evaluate the effectiveness of a home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition), comparing it with a version of the same program without these technologies (control condition). The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes).
METHODS


Based on a power analysis, we will recruit 100 cardiac patients and assign them evenly to the 2 parallel groups. Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language, have basic literacy of using smartphones, and are without medical conditions that may increase risks associated with PA. In a face-to-face meeting with a nurse practitioner, all patients are prescribed a 3-week exercise program at home (2 walking exercises per day with increasing duration), based on national and international guidelines and tailored to their physical conditions after cardiac intervention. Their physical activities (daily steps) will be measured by the Axivity AX3 accelerometer worn at hip position. Patients in the treatment group will also be supported by a Neo Health One self-tracking device and a mobile platform called Heart Angel, through which they are monitored and coached by their nurses. After the study, all patients will perform a bicycle ergometer test and return the devices within 1 week. In addition, 5 questionnaires will be sent to the patients by emails to assess their self-efficacy toward PA and other psychological states for exploratory analyses (at discharge, at the end of each monitoring week, and 1 week after the study). To minimize bias, the randomization procedure will be performed after introducing the exercise program, so the nurse practitioners are blind to the experimental conditions until that point.
RESULTS


The study protocol has been approved by the Medical Research Ethics Committees United on February 26, 2018 (NL 62142.100.17/R17.51). By the end of 2018, we completed a small pilot study with 8 patients and the results based on interviews and app usage data suggest that a larger clinical trial with the targeted population is feasible. We expect to complete the RCT by the end of 2021, and statistical analyses will follow.
CONCLUSIONS


Results of the RCT will help us to test the hypothesized benefits of self-tracking and mobile-based coaching for cardiac patients in home-based exercise programs during the discharge-rehabilitation gap. If the results are positive, cost-effectiveness analysis will be performed based on the insights of the study to inform the translation of the technology-enhanced program to clinical practice. We also note limitations of the trial in the discussion.
TRIAL REGISTRATION


Registered at Netherlands Trial Register NL8040; https://www.trialregister.nl/trial/8040.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/16737.",2020,"The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes).
","['Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language', 'Cardiac Surgery Patients', '100 cardiac patients and assign them evenly to the 2 parallel groups']","['RCT', 'Self-Tracking and Mobile-Based Coaching', 'exercise program at home (2 walking exercises per day with increasing duration', 'home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0376241', 'cui_str': 'Dutch language'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],100.0,0.045334,"The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes).
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Soliman-Hamad', 'Affiliation': 'Catharina Ziekenhuis Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Robijns', 'Affiliation': 'Scamander, Utrecht, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Verberkmoes', 'Affiliation': 'Catharina Ziekenhuis Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Verstappen', 'Affiliation': 'Catharina Ziekenhuis Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Wijnand A', 'Initials': 'WA', 'LastName': 'IJsselsteijn', 'Affiliation': 'Eindhoven University of Technology, Eindhoven, Netherlands.'}]",JMIR research protocols,['10.2196/16737']
1873,32814120,Development and preliminary testing of a technology-enhanced intervention to improve energy intake regulation in children.,"Interventions designed to improve children's self-regulation of energy intake have yielded mixed results. We tested the efficacy of a technology-enhanced intervention designed to teach children to eat in response to internal hunger and fullness cues. Thirty-two children (mean age 4.9 ± 0.8 y) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions, each scheduled approximately 1 week apart. The intervention was conducted across weeks 4-7 in small groups focused on teaching children how food travels through the body and how to respond to hunger and fullness signals. Children's short-term energy compensation, a measure of intake regulation, was collected at baseline and follow-up using a preloading protocol. Twenty-five minutes prior to receiving a standardized test meal, children consumed a low-energy (3 kcal) or high-energy (150 kcal) preload beverage, presented in random order at baseline and follow-up. Knowledge of intervention concepts was also assessed at baseline and follow-up. Linear mixed models were used to examine changes in short-term energy compensation and knowledge from baseline to follow-up. Knowledge related to the intervention improved from baseline to follow-up (3.5 ± 0.3 to 7.0 ± 0.3 correct responses out of a possible 10; P < 0.001). Children's energy compensation also improved from baseline to follow-up, as evidenced by a time-by-preload condition interaction (P = 0.02). However, this improvement was driven by boys who increased the adjustment for beverage energy content from baseline to follow-up (P = 0.04). Girls showed no change in energy compensation with the intervention (P = 0.58). The overall increase in knowledge, paired with the improvement in energy compensation in boys, suggests that this technology-enhanced intervention may be efficacious for some children. Further research is needed to determine whether boys and girls will benefit from different, personalized intervention strategies for obesity prevention.",2020,Girls showed no change in energy compensation with the intervention (P = 0.58).,"['Thirty-two children (mean age 4.9\u202f±\u202f0.8\u202fy) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions', 'children']","['technology-enhanced intervention', 'standardized test meal, children consumed a low-energy (3\u202fkcal) or high-energy (150\u202fkcal) preload beverage']","['energy compensation', ""Children's energy compensation""]","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",32.0,0.0189846,Girls showed no change in energy compensation with the intervention (P = 0.58).,"[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Reigh', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 110 Chandlee Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 226 Henderson Building, University Park, PA, 16802, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'The Pennsylvania State University, Center for Childhood Obesity Research and Department of Nutritional Sciences. 129 Noll Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Department of Pediatrics. 12631 East 17th Avenue, Mail Stop F-561, Academic Office Building, Room 2609; Aurora, CO, 80045, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'The Pennsylvania State University, Departments of Nutritional Sciences and Food Science. 321 Chandlee Laboratory, University Park, PA, 16802, USA. Electronic address: klk37@psu.edu.'}]",Appetite,['10.1016/j.appet.2020.104830']
1874,32815759,Long-term durability of immunogenicity induced by standard and triple-dose hepatitis B vaccine in patients receiving methadone maintenance treatment.,"Objectives We explored the long-term immunogenicity induced by 60 μg and 20 μg hepatitis B vaccines among patients receiving methadone maintenance treatment (MMT). Methods In initial study, a randomized controlled trial was conducted, in which patients receiving MMT were administered 20 µg (IM20 group) or 60 µg (IM60 group) hepatitis B vaccines at months 0, 1, and 6. In this study, the responders at month 7 were followed-up at months 18, 30, and 42 to estimate long-term immunogenicity. Results The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42. Vaccine-induced responses in 75% of patients were observed for 14.2 months in the IM20 group and for 20.0 months in the IM60 group, and differences between these two groups were non-significant ( P  > 0.05). Conclusion The three-dose 20 µg and 60 µg hepatitis B vaccines showed similar rapid hepatitis B surface antibody decreases. Abbreviations HBV, hepatitis B virus; MMT, methadone maintenance treatment; HCC, hepatocellular carcinoma; HBsAg, hepatitis B surface antigen; anti-HBs, hepatitis B surface antibody; HR, hazard ratio; CI, confidence interval; IQR, interquartile range; GEE, generalized estimated equation.",2020,"The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42.","['patients receiving methadone maintenance treatment (MMT', 'patients receiving methadone maintenance treatment']","['MMT were administered 20 µg (IM20 group) or 60 µg (IM60 group) hepatitis B vaccines', 'standard and triple-dose hepatitis B vaccine']","['Vaccine-induced responses', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.0397442,"The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42.","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Yuanting', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Linying', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Methadone Maintenance Treatment Clinic, Nanning Red Cross Hospital , Nanning, Guangxi, PR China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Yale School of Public Health , New Haven, CT, USA.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Chinese Preventive Medicine Association , Beijing, PR China.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}]",Expert review of vaccines,['10.1080/14760584.2020.1813577']
1875,32838701,Effect of an integrated neonatal care kit on cause-specific neonatal mortality in rural Pakistan.,"BACKGROUND


In 2018, Pakistan had the world's highest neonatal mortality rate. Within Pakistan, most neonatal deaths occur in rural areas where access to health facilities is limited, and robust vital registration systems are lacking. To improve newborn survival, there is a need to better understand the causes of neonatal death in high burden settings and engage caregivers in the promotion of newborn health.
OBJECTIVE


To describe the causes of neonatal death in a rural area in Pakistan and to estimate the effect of an integrated neonatal care kit (iNCK) on cause-specific neonatal mortality.
METHODS


We analyzed data from a community-based, cluster-randomized controlled trial of 5286 neonates in Rahim Yar Khan (RYK), Punjab, Pakistan between April 2014 and August 2015. In intervention clusters, Lady Health Workers (LHW) delivered the iNCK and education on its use to pregnant women while control clusters received the local standard of care. The iNCK included interventions to prevent and identify signs of infection, identify low birthweight (LBW), and identify and manage hypothermia. Verbal autopsies were attempted for all deaths. The primary outcome was cause-specific neonatal mortality.
RESULTS


Verbal autopsies were conducted for 84 (57%) of the 147 reported neonatal deaths. The leading causes of death were infection (44%), intrapartum-related complications (26%) and prematurity/LBW (20%). There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
CONCLUSION


The major causes of neonatal deaths in RYK, Pakistan mirror the global landscape of neonatal deaths. The iNCK did not significantly reduce any cause-specific neonatal mortality.",2020,"There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
","['rural Pakistan', '5286 neonates in Rahim Yar Khan (RYK), Punjab, Pakistan between April 2014 and August 2015']","['integrated neonatal care kit', 'Lady Health Workers (LHW) delivered the iNCK and education', 'integrated neonatal care kit (iNCK']","['infection', 'low birthweight (LBW), and identify and manage hypothermia', 'neonatal deaths in RYK, Pakistan mirror the global landscape of neonatal deaths', 'neonatal deaths', 'neonatal mortality due to prematurity/LBW', 'intrapartum-related complications', 'newborn survival', 'neonatal mortality rate', 'cause-specific neonatal mortality', 'Verbal autopsies']","[{'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0041497', 'cui_str': 'Tyrosine-tRNA ligase'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0004398', 'cui_str': 'Autopsy examination'}]",5286.0,0.166932,"There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Duby', 'Affiliation': 'Department of Pediatrics, McGill University , Montreal, Canada.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Pell', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Afsah', 'Initials': 'A', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Farrar', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Diego G', 'Initials': 'DG', 'LastName': 'Bassani', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Masawar', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}, {'ForeName': 'Sajid', 'Initials': 'S', 'LastName': 'Soofi', 'Affiliation': 'Center of Excellence in Women and Child Health, The Aga Khan University , Karachi, Pakistan.'}, {'ForeName': 'Shaun K', 'Initials': 'SK', 'LastName': 'Morris', 'Affiliation': 'Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.'}]",Global health action,['10.1080/16549716.2020.1802952']
1876,32840767,Better Treatment Values in Local Application of Tranexamic Acid (TXA) than Intravenous Application with the Same Dose in Total Hip Arthroplasty.,"INTRODUCTION


The aim of our study was to investigate the hemostatic effect of local and intravenously administered tranexamic acid (TXA) at the same dose in total hip arthroplasty.
METHODS


The prospective study included 72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019. The patients enrolled in the study were randomly divided into two groups: the observation group (36 patients were injected with 2.0 g TXA in 10 mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule) and the control group (36 patients were given an intravenous infusion of 2 g TXA in 200 mL 0.9% NaCl 30 min before the operation). In each patient, apparent blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion were compared between the two groups after treatment. Hematocrit (Hct) and hemoglobin (Hb) levels were recorded at postoperative day (POD) 1, 2, 3, 7, and 10. We also recorded the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) before the operation and 12 h postoperative and POD 1, 3, 7, and 10. The incidence of deep venous thrombosis and pulmonary embolism was also taken into account.
RESULTS


In the observation group, apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion were lower compared than the control group (P < 0.001). The levels of Hct and Hb were compared between the two groups at POD 1, 2, 3, 7, and 10, and the observation group reported higher levels of Hct and Hb (P < 0.001). The levels of CRP and IL-6 were compared between the two groups at POD 1, 3, 7, and 10, and the observation group reported lower levels of CRP and IL-6 than the control group (P < 0.001). On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
CONCLUSIONS


Local and intravenous applications of TXA at the same dose are effective approaches in terms of reducing bleeding and inflammatory reaction with a good safety profile; however, the effect of local application had superior therapeutic values.",2020,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
","['72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019', 'Total Hip Arthroplasty', 'total hip arthroplasty']","['intravenous infusion of 2\xa0g TXA', 'TXA in 10\xa0mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule', 'tranexamic acid (TXA', 'Tranexamic Acid (TXA', 'TXA']","['Hematocrit (Hct) and hemoglobin (Hb) levels', 'blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion', 'pulmonary embolism', 'hemostatic effect', 'levels of Hct and Hb', 'incidence of deep venous thrombosis', 'apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion', 'incidence of deep venous thrombosis and pulmonary embolism', 'levels of CRP and IL-6', 'levels of C-reactive protein (CRP) and interleukin-6 (IL-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0502723', 'cui_str': 'Structure of joint cavity'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",72.0,0.0284129,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
","[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Desi', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. panjiang@ccmu.edu.cn.'}]",Advances in therapy,['10.1007/s12325-020-01454-3']
1877,32835786,Attachment anxiety moderates the effect of oxytocin on negative emotion recognition: Evidence from eye-movement data.,"Valence-specific effects of oxytocin have been revealed in a selection of preceding studies, while others report that oxytocin could improve facial recognition, regardless of emotion valence. The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition. In this study, we used eye tracking to test whether attachment style moderates the effect of oxytocin on negative emotion recognition, which is crucial for social cognition. We employed a placebo-controlled, double-blind, within-participants design. The participants were 73 healthy individuals (41 men) who received a single dose of intranasal oxytocin (24 IU) on one occasion and a placebo dose on another occasion. Visual attention to the eye region was assessed on both occasions, through the completion of an emotion recognition task. Our results showed that oxytocin increased participants' eye gaze towards facial expressions. Among participants who received oxytocin, as opposed to a placebo, only individuals with high attachment anxiety displayed more eye gaze and less mouth gaze towards facial expression, regardless of emotion valence. Our findings confirmed that oxytocin increases gaze to the eye region, thus improving facial recognition, regardless of emotion valence, this relationship was moderated by attachment anxiety. Further, our results highlighted the importance of considering individual differences when evaluating the effects of oxytocin on emotion recognition.",2020,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.",['participants were 73 healthy individuals (41 men) who received a single dose of'],"['intranasal oxytocin', 'placebo', 'oxytocin']","['social behavior and cognition', 'eye gaze and less mouth gaze towards facial expression, regardless of emotion valence', 'emotion recognition', 'facial recognition, regardless of emotion valence', ""participants' eye gaze towards facial expressions"", 'eye gaze', 'negative emotion recognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0871740', 'cui_str': 'Face Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",73.0,0.296375,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.","[{'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Qingting', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China. Electronic address: chenxu@swu.edu.cn.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173015']
1878,32841525,"Antiobesity effect of Gynostemma pentaphyllum Extract (Actiponin): A Randomized, Double-Blind, Placebo-Controlled Trial.",,2020,,[],"['Gynostemma pentaphyllum Extract (Actiponin', 'Placebo']",[],[],"[{'cui': 'C0950016', 'cui_str': 'Gynostemma pentaphyllum'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3886709', 'cui_str': 'actiponin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.725478,,[],"Obesity (Silver Spring, Md.)",['10.1002/oby.22991']
1879,32791321,Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial.,"The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy. We propose a theoretically-based approach that incorporates expression of the self-conscious emotion of guilt and the written analogue of change talk as proposed mechanisms of intervention efficacy. We will also examine individual differences in guilt-proneness as a moderator of intervention efficacy. Heavy drinking college students (N = 600) will be randomly assigned to one of six expressive writing conditions based on a 2 (alcohol vs. distress) × 2 (guilt vs. no guilt) + 1 (control writing) + 1 (personalized feedback) design. Participation in the study involves completion of a screening assessment, a baseline assessment, three in-lab intervention sessions, post-intervention assessments, and follow-up assessments one-month, three-months, six months, and twelve-months later. If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.",2020,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","['College students', 'Heavy drinking college students (N\u202f=\u202f600', 'college students']","['\u202f1 (control writing', 'Guilt and expressive writing', 'six expressive writing conditions based on a 2 (alcohol vs. distress']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",[],600.0,0.018722,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jordanna Lembo', 'Initials': 'JL', 'LastName': 'Riggs', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, NJ, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Angosta', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America. Electronic address: jangosta@central.uh.edu.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Cunningham-Erdogdu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Psychology, University of Texas at Austin, Austin, TX, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106107']
1880,32791322,The Aging PLUS  trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults.,"BACKGROUND


Negative views of aging (NVOA), low self-efficacy beliefs, and poor goal planning skills represent risk factors that undermine adults' motivation to engage in physical activity (PA). Targeting these three risk factors may motivate adults to become physically active.
OBJECTIVE


To assess the efficacy of Aging PLUS , a 4-week educational program that explicitly targets NVOA, low self-efficacy beliefs, and poor goal planning skills compared to a 4-week health education program. The study also examines the role of NVOA, self-efficacy beliefs, and goal planning as the mechanisms underlying change in PA.
DESIGN


This randomized controlled trial (RCT) utilizes the experimental medicine approach to assess change in PA as a function of modifying three risk factors. The RCT recruitment target includes 288 mostly sedentary adults ranging in age from 45 to 75 years.
METHODS


Eligible middle-aged and older adults are recruited through community sources. Participants are randomized to either the Aging PLUS  or the control group. Participants in both groups are enrolled in the trial for 8 months total, with four assessment points: Baseline (pre-test), Week 4 (immediate post-test), Week 8 (delayed post-test), and Month 6 (long-term follow-up). The intervention takes place over 4 consecutive weeks with 2-h sessions each week. PA engagement is the primary outcome variable. Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
SUMMARY


By utilizing a multi-component approach and targeting a cluster of psychological mechanisms, the Aging PLUS  program implements the experimental medicine approach to health behavior change.",2020,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","['middle-aged and older adults', '288 mostly sedentary adults ranging in age from 45 to 75\u202fyears', 'Eligible middle-aged and older adults']",[],"['physical activity', 'Positive changes in NVOA, self-efficacy beliefs']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",288.0,0.0622321,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Diehl', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States. Electronic address: manfred.diehl@colostate.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Nehrkorn-Bailey', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kaigang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bland', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Skylar', 'Initials': 'S', 'LastName': 'Feltner', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Forsyth', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hulett', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Berkeley', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Mars', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Martinez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mast', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Monasterio', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'Schoenberg', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomson', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Tseng', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106105']
1881,32791810,"[Phase Ⅲ randomized controlled, multicenter, prospective study of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer: the HOPES Study].","Objective:  To evaluate the clinical efficacy and safety of recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine in patients with HER2 positive metastatic breast cancer.  Methods:  Patients were randomized 2∶1 to test group and control group. Patients in test group received Cipterbin (4 mg/kg loading dose and 2 mg/kg maintenance dose each week, IV) combined with vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV). Patients in control group received vinorelbine (25 mg/m(2) on days 1,8 and 15 of each 28 days, IV).The primary end point was progression free survival (PFS).  Results:  A total of 315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group). The median PFS of test group was significantly longer than that of control group, 39.1 weeks vs 14.0 weeks ( HR =0.24; 95 %CI , 0.16-0.36;  P< 0.000 1). The objective response rate (ORR) and disease control rate (DCR) in test group were significantly higher than those in control group, ORR was 46.7% vs 18.45% ( P< 0.000 1) and DCR was 79.72% vs 45.63% ( P< 0.000 1). The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.The most common adverse events associated with Cipterbin were infusion reactions. Left ventricular ejection fraction reduced to less than 50% in 5 patients, which were recovered. No serious cardiotoxicity.  Conclusion:  The recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine has significant efficacy and good safety. It is the optimized therapy regime for patients with taxane-pretreated HER2 positive metastatic breast cancer, which provides more targeted therapy opportunities for HER2 positive breast cancer patients in China.",2020,"The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.","['patients with taxane-pretreated HER2 positive metastatic breast cancer', 'HER2 positive breast cancer patients in China', 'patients with HER2 positive metastatic breast cancer', '315 patients were enrolled from Jan 2009 to Jan 2013 (212 in test group and 103 in control group']","['recombinant anti-HER2 humanized monoclonal antibody (Cipterbin) combined with vinorelbine', 'vinorelbine', 'Cipterbin']","['progression free survival (PFS', 'incidence of neutropenia, leucopenia and erythrocytopenia', 'ORR', 'median PFS', 'Left ventricular ejection fraction', 'objective response rate (ORR) and disease control rate (DCR', 'DCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0221395', 'cui_str': 'Erythropenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]",315.0,0.0281007,"The incidence of neutropenia, leucopenia and erythrocytopenia were higher in both groups, but there was no significant difference between two groups.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Xu', 'Affiliation': 'Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Di', 'Affiliation': 'Peking University Cancer Hospital & Institute, Beijing 100038, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou310000, China.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Jiao', 'Affiliation': 'The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Z S', 'Initials': 'ZS', 'LastName': 'Tong', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Fujian Cancer Hospital, Fuzhou 350011, China.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing 210009, China.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou 510080, China.'}, {'ForeName': 'Q T', 'Initials': 'QT', 'LastName': 'Yu', 'Affiliation': 'Guangxi Medical University Affiliated Cancer Hospital, Nanning 530021, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'The First Hospital of China Medical University, Shenyang110001, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Sunshine Guojian Pharmaceutical(Shanghai)Co., Ltd, Shanghai 200090, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 210002 China.'}, {'ForeName': 'Z F', 'Initials': 'ZF', 'LastName': 'Jiang', 'Affiliation': 'Department of Breast Oncology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100070, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200116-00105']
1882,32792403,Building social cohesion between Christians and Muslims through soccer in post-ISIS Iraq.,"Can intergroup contact build social cohesion after war? I randomly assigned Iraqi Christians displaced by the Islamic State of Iraq and Syria (ISIS) to an all-Christian soccer team or to a team mixed with Muslims. The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention. The intervention did not substantially affect behaviors in other social contexts, such as patronizing a restaurant in Muslim-dominated Mosul or attending a mixed social event, nor did it yield consistent effects on intergroup attitudes. Although contact can build tolerant behaviors toward peers within an intervention, building broader social cohesion outside of it is more challenging.",2020,"The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention.",[],['Iraqi Christians displaced by the Islamic State of Iraq and Syria (ISIS) to an all-Christian soccer team or to a team mixed with Muslims'],[],[],"[{'cui': 'C1556087', 'cui_str': 'Iraqi'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0039138', 'cui_str': 'Syria'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]",[],,0.027518,"The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention.","[{'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Mousa', 'Affiliation': 'Stanford University, Palo Alto, CA 94305, USA.'}]","Science (New York, N.Y.)",['10.1126/science.abb3153']
1883,32795739,"Effects of the Lysulin™ supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial.","BACKGROUND AND AIMS


Diabetes is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes. Present study aims to investigate whether a product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects in pre-diabetes.
METHODS


A randomized, double-blind, placebo-controlled trial was conducted for a period of 6 months. The two parallel groups (1:1) were Lysulin™ (Interventional group-IG) and placebo (control group-CG). Evaluations were done at baseline, 1, 3 and 6 months. Primary outcome was defined as change in glycaemic control measured by HbA1c from baseline. Other outcomes included change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile from baseline. Three multiple regression analyses were performed, where change in FPG, 2-h OGTT, and HbA1c post intervention from baseline respectively were the continuous dependent variable with other independent variables.
RESULTS


One hundred and ten participants were recruited, 50% (n = 55) were males and mean age (±SD) was 46.7 ± 9.9 years. A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018). FPG, 2-h OGTT and HbA1c significantly reduced in the IG only. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the IG. In all three regression models the best predictor of respective dependent variable was Lysulin™ treatment.
CONCLUSIONS


Lysulin™ improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. Treatment also showed a beneficial reduction in total and LDL cholesterol levels.
TRIAL REGISTRATION


Sri Lanka Clinical Trials Registry, identifier: SLCTR/2018/022 (http://slctr.lk/trials/1290). Registered on 13th July 2018; Study protocol version 2.0 (23rd March 2018).",2020,"A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018).","['One hundred and ten participants were recruited, 50% (n\xa0=\xa055) were males and mean age (±SD) was 46.7\xa0±\xa09.9 years']","['Lysulin™', 'Lysulin™ supplementation', 'product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C', 'placebo']","['change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile', 'FPG, 2-h OGTT and HbA1c', 'change in glycaemic control', 'pre-diabetes', 'total cholesterol and LDL cholesterol', 'total and LDL cholesterol levels', 'glycaemic control']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",110.0,0.642793,"A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018).","[{'ForeName': 'Priyanga', 'Initials': 'P', 'LastName': 'Ranasinghe', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. Electronic address: priyanga@pharm.cmb.ac.lk.'}, {'ForeName': 'Ranil', 'Initials': 'R', 'LastName': 'Jayawardena', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka; Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: ranil7@gmail.com.'}, {'ForeName': 'Lal', 'Initials': 'L', 'LastName': 'Chandrasena', 'Affiliation': 'Nawaloka Hospital Research and Education Foundation (NHREF), Nawaloka Hospitals PLC, Colombo, Sri Lanka. Electronic address: dgm@nawaloka.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.07.023']
1884,32795903,Ventilatory support during whole-body row training improves oxygen uptake efficiency in patients with high-level spinal cord injury: A pilot study.,"High-level spinal cord injury (SCI) is characterized by profound respiratory compromise. One consequence is a limitation of whole-body exercise-based rehabilitation, reducing its cardioprotective effect. We investigated the use of ventilatory support during training on cardiorespiratory response to exercise. Nine subjects with high-level SCI (T3-C4) were included in this double-blind sham-controlled study. All had training adaptations plateauing for more than 6 months before enrolling in the study. After performing baseline assessment, participants were randomly assigned to continue training with non-invasive ventilation (NIV: n = 6: IPAP = 20 ± 2, EPAP: 3 cmH 2 O) or sham (n = 3: IPAP = 5, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests. We compared the oxygen uptake efficiency slope (OUES, the rate of increases in VO 2  in relation to increasing VE) before and after training. Training with NIV increased OUES both compared to baseline (4.1 ± 1.1 vs. 3.4 ± 1.0, i.e. +20 ± 12%, p < 0.05) and Sham (p = 0.01), representing an increase in ability to uptake oxygen for a given ventilation. This result was sustained without NIV during the test, suggesting improved cardiopulmonary reserve. Best responders were the youngest whose characteristics were very similar to sham participants. In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham). Our results are very suggestive of a positive effect of ventilatory support during whole-body exercise in high-level SCI. Training adaptations found are of great importance since this sub-population of patients have the greatest need for exercise-based cardio-protection.",2020,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","['Nine subjects with high-level SCI (T3-C4', 'patients with high-level spinal cord injury']","['continue training with non-invasive ventilation (NIV: n\xa0=\xa06: IPAP\xa0=\xa020\xa0±\xa02, EPAP: 3 cmH 2 O) or sham (n\xa0=\xa03: IPAP\xa0=\xa05, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests', 'Ventilatory support during whole-body row training']","['oxygen uptake efficiency', 'weekly rowing distance', 'ability to uptake oxygen', 'oxygen uptake efficiency slope (OUES']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",9.0,0.0857854,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, 75013, Paris, France. Electronic address: isabelle.vivodtzev@sorbonne.universite.fr.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Napolitano', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106104']
1885,32798689,TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker.,"BACKGROUND


Cisplatin and paclitaxel are active in triple-negative breast cancer (TNBC). Despite different mechanisms of action, effective predictive biomarkers to preferentially inform drug selection have not been identified. The homologous recombination deficiency (HRD) assay (Myriad Genetics, Inc.) detects impaired double-strand DNA break repair and may identify patients with BRCA1/2-proficient tumors that are sensitive to DNA-targeting therapy. The primary objective of TBCRC 030 was to detect an association of HRD with pathologic response [residual cancer burden (RCB)-0/1] to single-agent cisplatin or paclitaxel.
PATIENTS AND METHODS


This prospective phase II study enrolled patients with germline BRCA1/2 wild-type/unknown stage I-III TNBC in a 12-week randomized study of preoperative cisplatin or paclitaxel. The HRD assay was carried out on baseline tissue; positive HRD was defined as a score ≥33. Crossover to an alternative chemotherapy was offered if there was inadequate response.
RESULTS


One hundred and thirty-nine patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over to an alternative provider-selected preoperative chemotherapy regimen due to inadequate clinical response. HRD results were available for 104 tumors (74.8%) and 74 (71.1%) were HRD positive. The RCB-0/1 rate was 26.4% with cisplatin and 22.3% with paclitaxel. No significant association was observed between HRD score and RCB response to either cisplatin [odds ratio (OR) for RCB-0/1 if HRD positive 2.22 (95% CI: 0.39-23.68)] or paclitaxel [OR for RCB-0/1 if HRD positive 0.90 (95% CI: 0.19-4.95)]. There was no evidence of an interaction between HRD and pathologic response to chemotherapy.
CONCLUSIONS


In this prospective preoperative trial in TNBC, HRD was not predictive of pathologic response. Tumors were similarly responsive to preoperative paclitaxel or cisplatin chemotherapy.",2020,"RESULTS


139 patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over due to inadequate clinical response.","['patients with germline BRCA1/2 wild-type/unknown stage I-III TNBC to 12 weeks of', 'triple-negative breast cancer', 'patients with BRCA1/2-proficient tumors', '139 patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over due to inadequate clinical response', 'TBCRC 030']","['paclitaxel', 'alternative chemotherapy', 'cisplatin', 'preoperative cisplatin vs. paclitaxel', 'cisplatin or paclitaxel', 'preoperative cisplatin or paclitaxel', 'Cisplatin and paclitaxel', 'paclitaxel or cisplatin chemotherapy']","['HRD score and RCB response', 'HRD results', 'HRD positive', 'RCB-0/1 rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",139.0,0.03069,"RESULTS


139 patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over due to inadequate clinical response.","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA. Electronic address: Erica_Mayer@dfci.harvard.edu.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jankowitz', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Falkson', 'Affiliation': 'University of Rochester Medical Center, Rochester, USA.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Marcom', 'Affiliation': 'Duke University Cancer Institute, Durham, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Traina', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rimawi', 'Affiliation': 'Baylor College of Medicine, Houston, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Specht', 'Affiliation': 'Seattle Cancer Care Alliance, Seattle, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Indiana University Simon Cancer Center, Indianapolis, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Stearns', 'Affiliation': 'Johns Hopkins University Sidney Kimmel Cancer Center, Baltimore, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tung', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Perou', 'Affiliation': 'University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, USA.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Richardson', 'Affiliation': 'Johns Hopkins University Sidney Kimmel Cancer Center, Baltimore, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Componeschi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trippa', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tan-Wasielewski', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Timms', 'Affiliation': 'Myriad Genetics Inc., Salt Lake City, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University Sidney Kimmel Cancer Center, Baltimore, USA.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.08.2064']
1886,32798723,"Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain during the Procedure-A Randomized Double-blind, Placebo-controlled Trial.","STUDY OBJECTIVE


To evaluate the effect of adding a local anesthetic to the distension medium in office diagnostic hysteroscopy using the vaginoscopic approach on pain during the procedure. Secondary aims included documenting side effects, patient satisfaction, and the time needed to complete the procedure.
DESIGN


Randomized double-blind placebo-controlled study.
SETTING


University-affiliated hospital; office hysteroscopy clinic.
PATIENTS


Total of 100 patients who underwent office hysteroscopies divided in half with 50 in the intervention group and 50 in the control group.
INTERVENTIONS


Ten mL of lidocaine 2% added to 1000 mL of saline solution that was used as the distension medium for hysteroscopy in the study group vs 1000 mL of saline alone in the control group.
MEASUREMENTS AND MAIN RESULTS


A significant difference was found in the increment of pain as measured by visual analog scale after the hysteroscopy between the 2 groups. Patients receiving lidocaine had an average rise of 1.9 in the visual analog scale score after the procedure compared with 2.9 in the control group (p = .033). There was also a nonsignificant trend for shorter duration of hysteroscopy in the intervention group compared with the control group (180.1 vs 222.1 seconds, p = .08). Patients' satisfaction was high in both groups (98% for the study group and 92% for the control group). Success rates were also similar between the 2 groups at approximately 95%. No side effects were recorded in either group.
CONCLUSION


The addition of local anesthetic to the distension medium in office hysteroscopy produces significant reduction in pain during the procedure without adding time to the procedure and without side effects.",2020,"There was also a non-significant trend for shorter duration of hysteroscopy in the intervention group compared to the control group (180.1 vs. 222.1 seconds, P= 0.08).",['100 patients that underwent office hysteroscopy divided to 50 in the intervention group and 50 in the control group'],"['Lidocaine', 'lidocaine', 'lidocaine 2% added into 1000 ml of saline solution', 'saline alone in the control group', 'placebo']","['increment of pain', 'side effects, patient satisfaction and the time needed to complete the procedure', 'VAS score', 'Pain', 'success rates', 'shorter duration of hysteroscopy', 'pain', 'Visual Analogue Scale (VAS', 'Patients satisfaction', 'side effects']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.213792,"There was also a non-significant trend for shorter duration of hysteroscopy in the intervention group compared to the control group (180.1 vs. 222.1 seconds, P= 0.08).","[{'ForeName': 'Oshri', 'Initials': 'O', 'LastName': 'Barel', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).. Electronic address: barelod@gmail.com.""}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Preuss', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Stolovitch', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Weinberg', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Barzilay', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}, {'ForeName': 'Moty', 'Initials': 'M', 'LastName': 'Pansky', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod and Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel (all authors).""}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.08.003']
1887,32798761,A randomized controlled trial on irrigation of open appendectomy wound with gentamicin- saline solution versus saline solution for prevention of surgical site infection.,"BACKGROUND


Surgical site infection (SSI) is one of the most common complications after abdominal surgery. The present trial examined the efficacy of saline irrigation of open appendectomy wound with or without topical antibiotics in prevention of SSI.
METHODS


This was a double-blind randomized trial on patients with acute appendicitis who underwent open appendectomy. Patients were randomly allocated to one of three equal groups; group I had layer-by-layer wound irrigation with gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group). The main outcome measures were the incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction.
RESULTS


205 patients (113 female) of a mean age of 27.9 years were included. The average hospital stay and pain scores were similar in the three groups. Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p = 0.005) and SSO (24.6% Vs 13.4% Vs 43.5%; p = 0.0003) as compared to group III. Groups I and II had comparable rates of SSI and SSO. The three groups had similar rates of wound seroma, hematoma, and dehiscence. Groups I and II had significantly higher satisfaction with the procedure than group III.
CONCLUSIONS


Layer-by-layer irrigation of open appendectomy wound decreased the rates of incisional SSI and SSO significantly compared to the no-irrigation group. Adding gentamicin to saline solution was useless to improve the outcome and did not decrease rates of SSI or other complications.",2020,"Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p= 0.005) and SSO (24.6 %","['patients with acute appendicitis who underwent open appendectomy', '205 patients (113 female) of a mean age of 27.9 years were included']","['gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group', 'Gentamicin- Saline Solution versus Saline Solution', 'saline irrigation of open appendectomy wound with or without topical antibiotics', 'gentamicin to saline solution']","['SSO', 'rates of SSI and SSO', 'rates of incisional SSI', 'rates of wound seroma, hematoma, and dehiscence', 'average hospital stay and pain scores', ""incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction"", 'rates of incisional SSI and SSO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0406831', 'cui_str': 'Wound seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",205.0,0.0751698,"Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p= 0.005) and SSO (24.6 %","[{'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: Sameh200@hotmail.com.'}, {'ForeName': 'Ahmed Hossam', 'Initials': 'AH', 'LastName': 'Elfallal', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: ahmedhos2011@gmail.com.'}, {'ForeName': 'Mohamed Anwar', 'Initials': 'MA', 'LastName': 'Abdel-Razik', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: drmohamedanwar1981@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Said', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: mmelsaidshehab@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elshobaky', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: elshobakyayman@yahoo.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.057']
1888,32800962,The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury.,"There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 27,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. Few studies have reported the safety and efficacy for use of these devices in the home and community environments, and none evaluated their impact on patient-centered outcomes through a randomized clinical trial (RCT). Absence of reported RCTs for powered exoskeletons may be due to a range of challenges, including designing, statistically powering, and conducting such a trial within an appropriate experimental framework. An RCT for the study of exoskeletal-assisted walking in the home and community environments also requires the need to address key factors such as: avoiding selection bias, participant recruitment and retention, training, and safety concerns, particularly in the home environment. These points are described here in the context of a national, multisite Department of Veterans Affairs Cooperative Studies Program-sponsored trial. The rationale and methods for the study design were focused on providing a template for future studies that use powered exoskeletons or other strategies for walking and mobility in people with immobilization due to SCI.",2020,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"['persons with chronic spinal cord injury', 'Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care', 'people with immobilization due to SCI']",['exoskeletal-assisted walking'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0719972,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Spungen', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Ann.Spungen@va.gov.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: William.Bauman@va.gov.'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Kousick.Biswas@va.gov.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Jones', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Karen.Jones2@va.gov.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Snodgrass', 'Affiliation': 'VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM 87106, United States of America; University of New Mexico, College of Pharmacy, Albuquerque, NM 87106, United States of America. Electronic address: Amanda.Snodgrass@va.gov.'}, {'ForeName': 'Lance L', 'Initials': 'LL', 'LastName': 'Goetz', 'Affiliation': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA 23249, United States of America; Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA 23298, United States of America. Electronic address: Lance.Goetz@va.gov.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gorman', 'Affiliation': 'Department of Neurology, University of Maryland School of Medicine, Baltimore, MD 21201, United States of America; VA Maryland Healthcare System, Baltimore, MD 21201, United States of America. Electronic address: Pgorman@umm.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Institute for Rehabilitation, West Orange, NJ 07052, United States of America; Rutgers New Jersey Medical School, Newark, NJ 07103, United States of America; Kessler Foundation, West Orange, NJ 07052, United States of America. Electronic address: skirshblum@kessler-rehab.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sabharwal', 'Affiliation': 'VA Boston Health Care System, Boston, MA 02130, United States of America; Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA 02115, United States of America. Electronic address: Sunil.Sabharwal2@va.gov.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'White', 'Affiliation': ""James A Haley Veterans' Hospital, Tampa, FL 33612, United States of America; University of South Florida, Tampa, FL 33612, United States of America. Electronic address: Kevin.White2@va.gov.""}, {'ForeName': 'Pierre K', 'Initials': 'PK', 'LastName': 'Asselin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Pierre.Asselin@va.gov.'}, {'ForeName': 'Kel G', 'Initials': 'KG', 'LastName': 'Morin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America. Electronic address: Kel.Morin@va.gov.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America. Electronic address: Christopher.Cirnigliaro@va.gov.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Huang', 'Affiliation': 'Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC 20420, United States of America. Electronic address: Grant.Huang@va.gov.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106102']
1889,32801847,"Erratum: Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial [Corrigendum].",[This corrects the article DOI: 10.2147/JPR.S247463.].,2020,[This corrects the article DOI: 10.2147/JPR.S247463.].,['Upper Shoulder and Neck Pain'],['Placebo'],[],"[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.604013,[This corrects the article DOI: 10.2147/JPR.S247463.].,[],Journal of pain research,['10.2147/JPR.S272270']
1890,32805434,Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.,"INTRODUCTION


Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
OBJECTIVE


To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs.
METHODS AND ANALYSIS


The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.",2020,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","['152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose', ""cardiorespiratory failure survivors' psychological distress (LIFT2""]","['self-directed mobile mindfulness intervention', 'LIFT intervention', 'telephone-based mindfulness program or education control']","['change in depression symptoms 1\u202fmonth from randomization measured by the PHQ-9 instrument', 'LIFT reduced distress symptoms', 'anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1444565', 'cui_str': 'Cardiorespiratory failure'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",152.0,0.143957,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Medical Center, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Department of Biostatistics & Bioinformatics, Duke Global Health Institute, Duke University, Durham, NC, United States of America. Electronic address: john.gallis@duke.edu.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: laura.porter@duke.edu.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Greeson', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: greeson@rowan.edu.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Gremore', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: tina.gremore@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ungar', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: amu@uw.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'McKeehan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: jeffrey.mckeehan@cuanschutz.edu.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'McDowell', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: brittany.mcdowell@duke.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McDaniel', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: hannah.mcdaniel@cuanschutz.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: marc.moss@cuanschutz.edu.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: houghc@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106119']
1891,32805520,Blunted salivary cortisol response to psychosocial stress in women with posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD) is characterized by alterations in the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system (SNS). There is evidence for a blunted HPA axis reactivity to psychosocial stress. Less is known about how the SNS reacts to psychosocial stress. Here, we compared the HPA axis and SNS responses to psychosocial stress and a non-stressful condition in patients with PTSD and in healthy individuals. Twenty-one women with PTSD and 32 healthy women participated in the Trier social stress test (TSST) and placebo TSST (P-TSST). We measured salivary cortisol, alpha amylase activity and blood pressure before and after the tests. Subjective perceived stress response was also assessed. We found a blunted cortisol response to the TSST in patients with PTSD compared with healthy participants 10 min (t (51) = -2.58, p = .01) and 25 min (t (51) = -2.16, p = .04) after TSST. We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05). Patients with PTSD, but not healthy participants, reported more dissociative symptoms (t (20) = -2.31, p = .03) and being more tired (t (20) = 2.90, p = .01) directly after TSST compared with the placebo condition. Our results suggest a blunted HPA stress reactivity and an increased subjective perceived stress response in female patients with PTSD. Longitudinal studies could test if these altered stress responses constitute a predisposition to or a cause of PTSD. Future studies should investigate whether these results are transferable to men.",2020,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"['Posttraumatic stress disorder (PTSD', 'patients with PTSD and in healthy individuals', 'women with posttraumatic stress disorder', 'patients with PTSD compared with healthy participants 10\xa0min (t (51)\xa0', 'female patients with PTSD', 'Twenty-one women with PTSD and 32 healthy women participated in the']","['TSST', 'Trier social stress test (TSST) and placebo TSST (P-TSST']","['blunted cortisol response', 'blunted HPA stress reactivity', 'Subjective perceived stress response', 'SNS reactivity', 'dissociative symptoms', 'salivary cortisol, alpha amylase activity and blood pressure', 'Blunted salivary cortisol response']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",21.0,0.0110716,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: sophie.metz@charite.de.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.014']
1892,32844586,Intake of Fermented Dairy Products Induces a Less Pro-Inflammatory Postprandial Peripheral Blood Mononuclear Cell Gene Expression Response than Non-Fermented Dairy Products: A Randomized Controlled Cross-Over Trial.,"SCOPE


It is aimed to investigate how intake of high-fat meals composed of different dairy products with a similar fat content affects postprandial peripheral blood mononuclear cell (PBMC) expression of inflammation-related genes, as well as circulating inflammatory markers and metabolites.
METHODS AND RESULTS


Healthy subjects (n = 47) consume four different high-fat meals composed of either butter, cheese, whipped cream, or sour cream in a randomized controlled cross-over study. Fasting and postprandial PBMC gene expression, plasma metabolites, and circulating inflammatory markers are measured. Using a linear mixed model, it is found that expression of genes related to lymphocyte activation, cytokine signaling, chemokine signaling, and cell adhesion is differentially altered between the four meals. In general, intake of the fermented products cheese and sour cream reduces, while intake of the non-fermented products butter and whipped cream increases, expression of these genes. Plasma amino acid concentrations increase after intake of cheese compared to the other meals, and the amino acid changes correlate with several of the differentially altered genes.
CONCLUSION


Intake of fermented dairy products, especially cheese, induces a less inflammatory postprandial PBMC gene expression response than non-fermented dairy products. These findings may partly explain inconsistent findings in studies on health effects of dairy products.",2020,"In general, intake of the fermented products cheese and sour cream reduced, while intake of the non-fermented products butter and whipped cream increased, expression of these genes.",['Healthy subjects (n = 47'],"['consumed four different high-fat meals composed of either butter, cheese, whipped cream or sour cream', 'Fermented Dairy Products']","['inflammatory postprandial PBMC gene expression response', 'Plasma amino acid concentrations', 'Fasting and postprandial PBMC gene expression, plasma metabolites and circulating inflammatory markers', 'lymphocyte activation, cytokine signaling, chemokine signaling, and cell adhesion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0452750', 'cui_str': 'Whipping cream'}, {'cui': 'C0452749', 'cui_str': 'Soured cream'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024262', 'cui_str': 'Blast Transformation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}]",47.0,0.0281853,"In general, intake of the fermented products cheese and sour cream reduced, while intake of the non-fermented products butter and whipped cream increased, expression of these genes.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rundblad', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Linn K L', 'Initials': 'LKL', 'LastName': 'Øyri', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Hansson', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Postboks 6050 Langnes, Tromsø, 9037, Norway.'}, {'ForeName': 'Ingvild H', 'Initials': 'IH', 'LastName': 'Ivan', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Gyrd O', 'Initials': 'GO', 'LastName': 'Gjevestad', 'Affiliation': 'Marketing Department, TINE SA, Postboks 7, Oslo, 0901, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Thoresen', 'Affiliation': 'Oslo Center for Biostatistics and Epidemiology, Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}, {'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Boks 1072 Blindern, Oslo, 0316, Norway.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000319']
1893,32795428,Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding.,"BACKGROUND


Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding.
OBJECTIVE


This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding.
STUDY DESIGN


This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function.
RESULTS


We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups.
CONCLUSION


Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.",2020,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","['women with heavy menstrual bleeding', 'heavy menstrual bleeding', 'Women with heavy menstrual bleeding, aged 34 and older, without a pregnancy wish or intracavitary pathology', '132 women were allocated to the levonorgestrel intrauterine system (baseline PBAC-score 616) and 138 women to endometrial ablation (baseline PBAC-score 630', '645 women as eligible of whom 270 women provided informed consent', '26 hospitals and in a network of general practices in the Netherlands', 'Women who start with the levonorgestrel intrauterine system, a reversible and less invasive treatment']","['levonorgestrel intrauterine system', 'levonorgestrel intrauterine system (Mirena) or to endometrial ablation, performed with the bipolar radiofrequency device (NovaSure', 'levonorgestrel intrauterine system and endometrial ablation', 'Levonorgestrel releasing intrauterine system versus endometrial ablation']","['risk of needing additional treatment', 'mean PBAC-scores', 'menstrual blood loss', 'blood loss at 24 months, measured with a Pictorial Blood Assessment Chart (PBAC)-score', 're-intervention rates, patient satisfaction, quality of life, and sexual function', 'patient satisfaction and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",645.0,0.184613,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","[{'ForeName': 'Pleun', 'Initials': 'P', 'LastName': 'Beelen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands; Department of General Practice, University of Maastricht, Maastricht, Netherlands. Electronic address: pleun.beelen@gmail.com.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'van den Brink', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Malou C', 'Initials': 'MC', 'LastName': 'Herman', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Peggy M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands.'}, {'ForeName': 'Janny H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Mak', 'Affiliation': 'Department of General Practice, University of Maastricht, Maastricht, Netherlands.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'van Meurs', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Sjors F', 'Initials': 'SF', 'LastName': 'Coppus', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'van der Steeg', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Heleen P', 'Initials': 'HP', 'LastName': 'Eising', 'Affiliation': 'Department of Obstetrics and Gynecology, Gelre Hospital, Apeldoorn, Netherlands.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Massop-Helmink', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Twente, Netherlands.'}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Klinkert', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Theodoor E', 'Initials': 'TE', 'LastName': 'Nieboer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Lucet F', 'Initials': 'LF', 'LastName': 'van der Voet', 'Affiliation': 'Department of Obstetrics and Gynecology, Deventer Hospital, Deventer, Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Veersema', 'Affiliation': 'Department of Reproductive Medicine and Gynecology, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Nicol A C', 'Initials': 'NAC', 'LastName': 'Smeets', 'Affiliation': 'Department of Obstetrics and Gynecology, Zuyderland Medical Centre, Heerlen, Netherlands.'}, {'ForeName': 'Joke M', 'Initials': 'JM', 'LastName': 'Schutte', 'Affiliation': 'Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Marchien', 'Initials': 'M', 'LastName': 'van Baal', 'Affiliation': 'Department of Obstetrics and Gynecology, Flevo Hospital, Almere, Netherlands.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marjolein Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Marlies Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands; Research School Grow, University of Maastricht, Maastricht, Netherlands.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.016']
1894,32795562,"Effects of Dual-Task Group Training on Gait, Cognitive Executive Function, and Quality of Life in People With Parkinson Disease: Results of Randomized Controlled DUALGAIT Trial.","OBJECTIVES


The aims of this study were to analyze the effects of a dual-task group program, to compare it with the effects of a single-task group program, and to analyze the effects of functional secondary tasks.
DESIGN


Single-blind randomized controlled trial.
SETTING


University laboratory and a rehabilitation gym at a health center.
PARTICIPANTS


Patients (N=40) with a diagnosis of Parkinson disease (mean age, 66.72y; age range, 44-79y) with Hoehn and Yahr stage I to III who were on medication were randomized to either a group with dual-task training or a group with single-task training (only gait).
INTERVENTION


Both interventions involved 20 sessions lasting 1 hour each and conducted twice a week. Dual-task training included walking exercises and cognitive or motor tasks carried out separately, then later performed together as a dual-task according to a progressive protocol in the same training session.
MAIN OUTCOME MEASURES


Velocity and spatiotemporal parameters of gait were measured without a secondary task and during dual-task gait combined with a visual, verbal, auditory, and motor task. In addition, executive cognitive function and quality of life were measured. Assessments were conducted at baseline, postrehabilitation, and at the 8-week follow-up.
RESULTS


The dual-task group demonstrated improved velocity and stride length time in all assessment conditions after training (P<.05), as well as perceived quality of life (P<.05). The single-task group experienced improvements in the same outcomes for only the motor condition (P<.05) after training, but failed to improve perceived quality of life (P>.05). Likewise, the dual-task group showed higher velocity and stride length after treatment than the single-task group across conditions. No significant changes were observed in cognitive performance (P>.05), although the dual-task group tended to improve performance during the executive function test.
CONCLUSIONS


Dual-task training in functional contexts is associated with greater improvements in velocity and stride length in patients with PD compared with regular physiotherapy without secondary tasks. Dual-task training also improves perceived quality of life.",2020,"Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05).","[""People (N = 40) with a diagnosis of Parkinson's disease (aged 66.72"", 'University laboratory, rehabilitation gym at health center', 'patients with PD', '44-79] years, Hoehn and Yahr stage I-II-III and on-medication', ""people with Parkinson's disease""]","['Dual-task training included walking exercises and cognitive or motor tasks carried out separately, later performed together as a dual-task according to a progressive protocol', 'dual-task group training', 'Dual tasks training', 'dual-task training or (2) a group with single-task training (only gait']","['cognitive performance', 'gait, cognitive executive function and quality of life', 'like their perceived Quality of life', 'Velocity, and Stride length time', 'Executive cognitive function and Quality of life', 'motor condition', 'velocity and stride length', 'Velocity and Stride length', 'Velocity and spatiotemporal parameters of gait were measured without a secondary task and during dual-task gait combined with a visual, verbal, auditory and motor task', 'perceived Quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589089', 'cui_str': 'Executive cognitive functions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",40.0,0.0321115,"Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05).","[{'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'San Martín Valenzuela', 'Affiliation': 'Unit of Personal Autonomy, Dependency and Mental Disorder Assessment, Faculty of Medicine, Universitat de València, València, Spain; Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, València, Spain; UBIC Research Group, Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, València, Spain; Centro Investigación Biomédica en Red de Salud Mental, CIBERSAM, Madrid, Spain.'}, {'ForeName': 'Lirios Dueñas', 'Initials': 'LD', 'LastName': 'Moscardó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, València, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'López-Pascual', 'Affiliation': 'Instituto de Biomecánica de Valencia, Universitat Politècnica de València, València, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, València, Spain; UBIC Research Group, Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, València, Spain. Electronic address: pilar.serra@uv.es.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Tomás', 'Affiliation': 'Department of Behavioral Sciences Methodology, Faculty of Psychology, Universitat de València, València, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.008']
1895,32803900,Effect of once-weekly exenatide on estimated glomerular filtration rate slope depends on baseline renal risk: A post hoc analysis of the EXSCEL trial.,"The effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on renal outcomes in patients with type 2 diabetes at high cardiovascular risk are modest or neutral. However, GLP-1RAs may confer clinical benefits in those at high risk of progressive renal function loss. We examined the effects of once-weekly exenatide (EQW) on estimated glomerular filtration rate (eGFR) slope and urinary albumin:creatinine ratio (UACR) as a function of baseline UACR in 3503 EXSCEL participants (23.7%) with eGFR data available and 2828 participants (19.2%) with UACR change data available. EQW improved eGFR slope assessed via mixed model repeated measures, compared with placebo, in participants with baseline UACR >100 mg/g (0.79 mL/min/1.73 m 2  /year [95% confidence interval {CI} 0.24-1.34]) and UACR >200 mg/g (1.32 mL/min/1.73 m 2  /year [95% CI 0.57-2.06]), but not at lower UACR thresholds. EQW reduced UACR, compared with placebo, assessed via analysis of covariance, consistently across subgroups with baseline UACR >30 mg/g (28.2% reduction), baseline UACR >100 mg (22.5% reduction) and baseline UACR >200 mg (34.5% reduction). This post hoc EXSCEL analysis suggests that EQW reduces UACR, with improvement in eGFR slope specifically in participants with elevated baseline UACR.",2020,"EQW reduced UACR, compared with placebo, assessed via ANCOVA consistently across subgroups with baseline UACR>30 mg/g (28.2% reduction), baseline UACR>100 ","['patients with type 2 diabetes at high cardiovascular (CV) risk', '3503 (23.7%) EXSCEL participants with eGFR data available and 2828 (19.2%) participants with UACR change data available', 'participants with baseline UACR>100', 'participants with elevated baseline UACR']","['exenatide', 'GLP-1 RA', 'exenatide (EQW', 'glucagon-like peptide-1 receptor agonists (GLP-1 RA', 'placebo']","['baseline UACR>200', 'baseline renal risk', 'eGFR slope and urinary albumin:creatinine ratio (UACR', 'baseline UACR>100', 'EQW reduced UACR', 'EQW improved eGFR slope', 'eGFR slope']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.427864,"EQW reduced UACR, compared with placebo, assessed via ANCOVA consistently across subgroups with baseline UACR>30 mg/g (28.2% reduction), baseline UACR>100 ","[{'ForeName': 'Annemarie B', 'Initials': 'AB', 'LastName': 'van der Aart-van der Beek', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Clegg', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Penland', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Boston, Massachusetts, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-Stage Development CVRM, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14175']
1896,32799029,Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women.,"STUDY OBJECTIVES


To determine whether insomnia patients with objective sleep disturbance are less responsive to cognitive and behavioral treatments than those without objective sleep disturbance, characterize effects of insomnia therapy on objective sleep, and determine whether reductions in nocturnal cognitive arousal correspond to changes in objective sleep.
METHODS


Secondary analysis of a single-site, randomized controlled trial. 113 postmenopausal women (56.40 ± 5.34 years) with menopause-related insomnia disorder were randomized to three treatment conditions: cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control. Primary outcomes were the Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters and were collected at pretreatment, posttreatment, and six-month follow-up.
RESULTS


Patients with lower pretreatment PSG sleep efficiency had lower rates of insomnia remission after active treatment relative to those with higher sleep efficiency (37.8% vs 61.8%). Neither CBTI and SRT produced clinically meaningful effects on PSG sleep. Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
CONCLUSIONS


Our findings support an emerging literature suggesting that insomnia patients with objective sleep disturbance may have blunted response to insomnia therapy. Research is needed to enhance treatments to better improve insomnia in patients with objective sleep disturbance. A lack of observed CBTI and SRT effects on PSG sleep suggests that these therapies may be presently ill-designed to improve objective sleep. Nocturnal cognitive arousal may represent an entry point to improve objective sleep latency in insomnia. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.",2020,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","['insomnia patients with objective sleep disturbance', 'postmenopausal women', 'patients with objective sleep disturbance', '113 postmenopausal women (56.40\xa0±\xa05.34 years) with menopause-related insomnia disorder']","['NAME', 'CBTI and SRT', 'cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control']","['Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters', 'PSG sleep', 'nocturnal cognitive arousal', 'Nocturnal cognitive arousal', 'PSG sleep latency', 'sleep efficiency', 'insomnia remission']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",113.0,0.0431924,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Chaewon', 'Initials': 'C', 'LastName': 'Sagong', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA. Electronic address: cdrake1@hfhs.org.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.024']
1897,32799056,Comparing the impact of educational messages based on an extended parallel process model on solid waste separation behaviors in female students: A four-group randomized trial.,"BACKGROUND


The increase in non-separated solid waste is a threat to environmental health. People may be motivated to reduce the destructive effects of waste accumulation in the environment by receiving educational messages and learning the proper methods of waste separation. This study aimed to determine the effect of educational messages on waste separation in dormitory students based on Extended Parallel Process Model (EPPM).
METHODS


This randomized controlled trial was performed on 320 students categorized into four groups from October to December 2019. After installing waste separation tags on separate containers, three types of messages were presented to encourage and educate waste separation in the following four groups: threat messages; efficacy messages; threat/efficacy messages; and control group. Data were collected prior to and one week after training by a self-reported valid and reliable questionnaire. They were analyzed in SPSS21.
RESULTS


In the efficacy group and threat/efficacy group, not only the mean scores of ""perceived threat associated with non-segregation and waste accumulation"", ""attitude"" and ""intention"" but also the mean score of ""efficacy"" and ""waste separation behavior"" were improved (P < 0.05). In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
DISCUSSION


Use of efficacy-based massages alone or in combination with the threat component was proposed to promote waste separation. No specific study has documented the effectiveness of messages based on EPPM on solid waste separation behaviors. The current study highlighted the effectiveness of using EPPM to promote waste-separation behavior in practice, not in theory.",2020,"In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
","['female students', '320 students categorized into four groups from October to December 2019', 'dormitory students based on Extended Parallel Process Model (EPPM']","['educational messages', 'EPPM']","['mean score of ""perceived barriers"" for waste separation', 'mean score of ""efficacy"" and ""waste separation behavior', 'mean scores of ""perceived threat associated with non-segregation and waste accumulation"", ""attitude"" and ""intention']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0080141', 'cui_str': 'Racial Segregation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",320.0,0.0326594,"In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
","[{'ForeName': 'Aazam', 'Initials': 'A', 'LastName': 'Abbasi', 'Affiliation': 'Student Research Committee, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Araban', 'Affiliation': 'Health Education and Promotion Department, Public Health School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Alidosti', 'Affiliation': 'Department of Public Health, Behbahan Faculty of Medical Sciences, Behbahan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Zamani-Alavijeh', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: fe.zamani@hlth.mui.ac.ir.'}]","Waste management (New York, N.Y.)",['10.1016/j.wasman.2020.07.041']
1898,32799180,The effect of small versus large clog size on emergency response time: A randomized controlled trial.,"OBJECTIVES


To assess the effect on healthcare professional emergency response time and safety of small compared to large clog size.
DESIGN


Randomized controlled trial.
SETTING


The intensive care unit of a single university medical centre in The Netherlands.
PARTICIPANTS


Intensive care medicine professionals.
INTERVENTIONS


Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125 m course from the coffee break room to the elevator providing access to the emergency department.
MAIN OUTCOME MEASURES


The primary outcome was the time to complete the running course. Height, shoe size, self-described fitness, age and staff category were investigated as possible effect modifiers. Secondary endpoints were reported clog comfort and suspected unexpected clog-related adverse events (SUCRAEs).
RESULTS


50 participants were randomized (25 to European size 38 clogs and 25 to size 47 clogs). Mean age was 37 years (SD 12) and 29 participants (58%) were female. The primary outcome was 4.4 s (95% CI -7.1; -1.6) faster in the size 5 clogs group compared to the size 12 clogs group. This effect was not modified by any of the predefined participant characteristics. No differences were found in reported clog comfort or SUCRAEs.
CONCLUSIONS


European size 38 clogs lead to faster emergency response times than size 47 clogs.
TRIAL REGISTRATION


NCT04406220.",2020,"No differences were found in reported clog comfort or SUCRAEs.
","['Intensive care medicine professionals', 'The intensive care unit of a single university medical centre in The Netherlands', 'Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125\xa0m course from the coffee break room to the elevator providing access to the emergency department', 'Mean age was 37\xa0years (SD 12) and 29 participants (58%) were female', '50 participants']",[],"['clog comfort and suspected unexpected clog-related adverse events (SUCRAEs', 'time to complete the running course', 'emergency response time', 'Height, shoe size, self-described fitness, age and staff category']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0013890', 'cui_str': 'Elevator'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0426931', 'cui_str': 'Shoe size'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",50.0,0.195819,"No differences were found in reported clog comfort or SUCRAEs.
","[{'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands. Electronic address: p.elbers@amsterdamumc.nl.'}, {'ForeName': 'Harm-Jan', 'Initials': 'HJ', 'LastName': 'de Grooth', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}]",Journal of critical care,['10.1016/j.jcrc.2020.07.028']
1899,32807013,Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial.,"BACKGROUND


Low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1) has demonstrated beneficial effects on motor recovery, but evidence among patients with subacute stroke is lacking. We aimed to investigate whether 1-Hz rTMS over the contralesional M1 versus sham rTMS could improve arm function in patients with subacute ischemic stroke when combined with rehabilitative motor training.
METHODS


In total, 77 patients who were within 90 days after their first-ever ischemic stroke were enrolled and randomly allocated to either real (n = 40) or sham rTMS (n = 37). We delivered 1-Hz 30-minute active or sham rTMS before each daily 30-minute occupational therapy sessions over a 2-week period. The primary endpoint was changes in the Box and Block Test (BBT) score immediately after the end of treatment (EOT). Secondary analyses assessed changes in Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength.
CLINICAL TRIAL REGISTRATION


ClinialTrials.gov (NCT02082015).
RESULTS


Changes in BBT immediately after the end of treatment did not differ significantly between the 2 groups ( P  = .267). Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham;  P  = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham;  P  = .023), only in the group without cortical involvement.
CONCLUSION


The effects of real and sham rTMS did not differ significantly among patients within 3 months poststroke. The location of stroke lesions should be considered for future clinical trials.",2020,"Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham;  P  = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham;  P  = .023), only in the group without cortical involvement.
","['Subacute Ischemic Stroke', '77 patients who were within 90 days after their first-ever ischemic stroke', 'patients within 3 months poststroke', 'patients with subacute stroke', 'patients with subacute ischemic stroke']","['contralesional M1 versus sham rTMS', '1-Hz rTMS', 'sham rTMS', 'Low-frequency repetitive transcranial magnetic stimulation (rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex', '1-Hz 30-minute active or sham rTMS']","['Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength', 'BBT', 'Box and Block Test (BBT) score']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",77.0,0.483945,"Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham;  P  = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham;  P  = .023), only in the group without cortical involvement.
","[{'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': 'Department of Rehabilitation Medicine, Dongguk University College of Medicine, Dongguk University Ilsan Hospital, Ilsandong-gu, Goyang, South Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948610']
1900,32810344,A pilot study using a small-sided games program to modify cardiovascular health in sedentary Indigenous men.,"ISSUES ADDRESSED


To determine cardiovascular health benefits in Indigenous men following short-duration small-sided games.
METHODS


Fourteen sedentary Indigenous males (35.6 SD 7.2 years), randomly assigned to a small-sided games (SSG) or a non-exercising control. Small-sided 20-minute (4 × 5 minute bouts) games of touch football were played 2 x/week for 9 weeks. Waist and hip circumferences, height, total body mass (kg), fat (%), fat free mass (kg), muscle mass (kg), resting heart rate (bpm), systolic blood pressure (mmHg), total cholesterol and high-density lipid concentrations were measured and waist-hip ratios, body mass index (BMI), heart rate variability (HRV), metabolic age and Framingham risk calculated before and after the exercise intervention. Between group differences were examined using unpaired t tests (welch corrected) and described using Cohen's effect size (ES) differences (corrected to determine hedges g).
RESULTS


Significant between group differences favouring the SSG group were observed in body mass (P = .039, ES = 0.18), BMI (P = .031, ES = 0.22) and metabolic age (P = .033, ES = 0.29) and in HRV parameters of approximate entropy (ApEN; P = .01, ES = 1.65) and sample entropy (SampEN; P = .0193, ES = 1.40).
CONCLUSION


Middle-aged Indigenous men can gain cardiovascular health benefits following short bouts of small-sided game play accumulating in 40-minutes of exercise each week. SO WHAT?: Short-duration SSG may address many exercise barriers, and offer a sustainable form of exercise to improve cardiovascular health amongst Indigenous men.",2020,"RESULTS


Significant between group differences favouring the SSG group were observed in body mass (p = 0.039, ES = 0.2), BMI (p = 0.031, ES = 0.24) and metabolic age (p = 0.033, ES = 0.32) and in HRV parametes of approximate entropy (ApEN; p = 0.01, ES = 1.82) and sample entropy (SampEN; p = 0.0193, ES = 1.55).
CONCLUSION


Middle aged Indigenous men can gain cardiovascular health benefits following short-bouts of small-sided game play accumulating in 40-minutes of exercise each week.","['Indigenous men', 'Fourteen sedentary Indigenous males (35.6 SD 7.2 years', 'Indigenous men following short-duration small-sided games', 'sedentary Indigenous men']","['small-sided games program', 'small-sided games (SSG) or a non-exercising control']","['Waist and hip circumferences, height, total body mass (kg), fat (%), fat free mass (kg), muscle mass (kg), resting heart rate (bpm), systolic blood pressure (mmHg), total cholesterol and high-density lipid concentrations were measured and waist-hip ratios, body mass index (BMI), heart rate variability (HRV), metabolic age and Framingham risk calculated', 'body mass', 'BMI']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",14.0,0.0775729,"RESULTS


Significant between group differences favouring the SSG group were observed in body mass (p = 0.039, ES = 0.2), BMI (p = 0.031, ES = 0.24) and metabolic age (p = 0.033, ES = 0.32) and in HRV parametes of approximate entropy (ApEN; p = 0.01, ES = 1.82) and sample entropy (SampEN; p = 0.0193, ES = 1.55).
CONCLUSION


Middle aged Indigenous men can gain cardiovascular health benefits following short-bouts of small-sided game play accumulating in 40-minutes of exercise each week.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Sampson', 'Affiliation': 'Centre of Medical and Exercise Physiology, School of Medicine, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Venables', 'Affiliation': 'Illawarra Aboriginal Medical Service, Wollongong, NSW, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Debeneditics', 'Affiliation': 'Talent Department, South Australian National Football League, Adelaide, SA, Australia.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Centre of Medical and Exercise Physiology, School of Medicine, University of Wollongong, Wollongong, NSW, Australia.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.409']
1901,32810504,Acute exposure to traffic-related air pollution alters antioxidant status in healthy adults.,"BACKGROUND


Exposure to traffic-related air pollution is associated with an increased risk of cardiovascular and respiratory disease. Evidence suggests that inhaled pollutants precipitate these effects via multiple pathways involving oxidative stress.
OBJECTIVE


Postulating that a decrease in circulating antioxidant levels reflect an oxidative response, we investigated the effect of inhaled diesel exhaust (DE) on the ratio of reduced to oxidized glutathione (GSH/GSSG) in healthy adults, and whether pre-exposure antioxidant supplementation blunted this response. We also examined exposure-related changes in antioxidant/stress response leukocyte gene expression (GCLc, HMOX-1, IL-6, TGFβ) and plasma IL-6 levels.
METHODS


Nineteen nonsmoking adults participated in a double-blind, randomized, four-way crossover study. Each subject completed 120-min exposures to filtered air and DE (200 μg/m 3 ), with and without antioxidant pretreatment. Antioxidant comprised 1000 mg ascorbate for 7 days and 1200 mg N-acetylcysteine 1 day prior to exposure, with 1000 mg and 600 mg, respectively, administered 2 h prior to exposure. Whole blood glutathione was measured pre- and post-exposure; plasma IL-6 and mRNA expression were quantified pre, during and post exposure.
RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p = 0.001) and a 4-fold increase in IL-6 mRNA (p = 0.01) post exposure. Antioxidant pretreatment did not significantly mediate the effect of DE exposure on GSH/GSSG, though appeared to decrease the effect of exposure on IL-6 mRNA expression.
CONCLUSIONS


Acute DE inhalation induced detectable oxidative effects in healthy adults, which were not significantly attenuated by the selected antioxidant pre-treatment. This finding supports the premise that oxidative stress is one mechanism underlying the adverse effects of traffic-related air pollution.",2020,"RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p=0.001) and a 4-fold increase in IL-6 mRNA (p=0.01) post exposure.","['Nineteen nonsmoking adults', 'healthy adults']","['traffic-related air pollution', 'Antioxidant', 'oxidized glutathione (GSH/GSSG', 'inhaled diesel exhaust (DE']","['GSH/GSSG', 'Whole blood glutathione was measured pre- and post-exposure; plasma IL-6 and mRNA expression', 'oxidative effects', 'antioxidant/stress response leukocyte gene expression (GCLc, HMOX-1, IL-6, TGFβ) and plasma IL-6 levels', 'IL-6 mRNA']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",19.0,0.25279,"RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p=0.001) and a 4-fold increase in IL-6 mRNA (p=0.01) post exposure.","[{'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Cosselman', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA. Electronic address: kecs@uw.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Stapleton', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Trenga', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Timothy V', 'Initials': 'TV', 'LastName': 'Larson', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA; Department of Civil and Environmental Engineering, USA.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Kaufman', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA; Department of Medicine, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}]",Environmental research,['10.1016/j.envres.2020.110027']
1902,32811629,Factors associated with withdrawal symptoms and anger among people resuscitated from an opioid overdose by take-home naloxone: Exploratory mixed methods analysis.,"INTRODUCTION


Take-home naloxone (THN) is a clinically effective and cost-effective means of reducing opioid overdose fatality. Nonetheless, naloxone administration that successfully saves a person's life can still produce undesirable and harmful effects.
AIM


To better understand factors associated with two widely reported adverse outcomes following naloxone administration; namely the person resuscitated displays: i. withdrawal symptoms and ii. anger.
METHODS


A mixed methods study combining a randomized controlled trial of overdose education and naloxone prescribing to people with opioid use disorder and semi-structured qualitative interviews with trial participants who had responded to an overdose whilst in the trial. All data were collected in New York City (2014-2019). A dataset (comprising demographic, pharmacological, situational, interpersonal, and overdose training related variables) was generated by transforming qualitative interview data from 47 overdose events into dichotomous variables and then combining these with quantitative demographic and overdose training related data from the main trial. Associations between variables within the dataset and reports of: i. withdrawal symptoms and ii. anger were explored using chi-squared tests, t-tests, and logistic regressions.
RESULTS


A multivariate logistic regression found that people who had overdosed were significantly more likely to display anger if the person resuscitating them criticized, berated or chastised them during resuscitation (adjusted OR = 27 [95% CI = 4.0-295]). In contrast, they were significantly less likely to display anger if the person resuscitating them communicated positively with them (OR = 0.10 [95% CI = 0.01-0.78]). Both positive and negative communication styles were independently associated with anger, and communication was associated with 59% of the variance in anger. There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
CONCLUSIONS


Contrary to common assumptions, withdrawal symptoms and anger following naloxone administration may be unrelated phenomena. Findings are consistent with previous research that has suggested that a lay responder's positive or reassuring communication style may lessen anger post overdose. Implications for improving THN programmes and naloxone administration are discussed.",2020,"There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
","['people with opioid use disorder and semi-structured qualitative interviews with trial participants who had responded to an overdose whilst in the trial', 'person resuscitated displays']","['overdose education and naloxone', 'naloxone (THN', 'naloxone']",['withdrawal symptoms'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}]",,0.126341,"There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: joanne.neale@kcl.ac.uk.""}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Kalk', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: nicola.kalk@kcl.ac.uk.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom. Electronic address: caral.brown@kcl.ac.uk.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: lb3227@cumc.columbia.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: felipe.castillo@nyspi.columbia.edu.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: jermaine.jones@nyspi.columbia.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: john.strang@kcl.ac.uk.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: sdc10@cumc.columbia.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108099']
1903,32812888,A Mobile Health Intervention for Adolescents Exposed to Secondhand Smoke: Pilot Feasibility and Efficacy Study.,"BACKGROUND


Secondhand smoke (SHS) exposure in children and adolescents has adverse health effects. For adolescents of lower socioeconomic status (SES), exposure is widespread, evidenced in the measurement of urinary cotinine, a major metabolite of nicotine. Direct intervention with exposed children has been proposed as a novel method, yet there is minimal evidence of its efficacy. Combining this approach with a mobile health (mHealth) intervention may be more time and cost-effective and feasible for adolescent populations.
OBJECTIVE


In this pilot study, we assessed the feasibility and preliminary evidence of efficacy of a 30-day text message-based mHealth intervention targeted at reducing SHS exposure in adolescent populations of low SES.
METHODS


For the study, 14 nonsmoking and nonvaping participants between the ages of 12-21 years exposed to SHS were enrolled. The intervention consisted of a daily text message sent to the participants over the course of a month. Text message types included facts and information about SHS, behavioral methods for SHS avoidance, or true-or-false questions. Participants were asked to respond to each message within 24 hours as confirmation of receipt. Feasibility outcomes included completion of the 30-day intervention, receiving and responding to text messages, and feedback on the messages. Efficacy outcomes included a reduction in urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness.
RESULTS


Of the 14 participants that were enrolled, 13 completed the intervention. Though not required, all participants had their own cell phones with unlimited text messaging plans. Of the total number of text messages sent to the 13 completers, 91% (372/407) of them received on-time responses. Participant feedback was generally positive, with most requesting more informational and true-or-false questions. In terms of efficacy, 54% (6/11) of participants reduced their cotinine levels (however, change for the group overall was not statistically significant (P=.33) and 45% (5/11) of participants increased their cotinine levels. Of the total number of true-or-false questions sent across all completers, 77% (56/73) were answered correctly. Participants' ratings of message effectiveness averaged 85 on a scale of 100.
CONCLUSIONS


In this pilot study, the intervention was feasible as the majority of participants had access to a cell phone, completed the study, and engaged by responding to the messages. The efficacy of the study requires further replication, as only half of the participants reduced their cotinine levels. However, participants answered the majority of true-or-false questions accurately and reported that the messages were helpful.",2020,"Efficacy outcomes included a reduction in urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness.
","['adolescent populations of low SES', '14 participants that were enrolled', '14 nonsmoking and nonvaping participants between the ages of 12-21 years exposed to SHS were enrolled', 'Adolescents Exposed to Secondhand Smoke', 'children and adolescents']","['Mobile Health Intervention', 'mobile health (mHealth) intervention', '30-day text message-based mHealth intervention']","['cotinine levels', 'completion of the 30-day intervention, receiving and responding to text messages, and feedback on the messages', ""urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0559554,"Efficacy outcomes included a reduction in urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness.
","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Giberson', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Shonul', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Pediatrics, Zuckerberg San Francisco General Hospital, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, United States.'}]",JMIR formative research,['10.2196/18583']
1904,32814493,Effectiveness of acupoint pressure on older people with constipation in nursing homes: a double-blind quasi-experimental study.,"Aims:  To compare the differences between acupoint pressure, abdominal massage and laxatives in treatment of constipation for residents in two nursing homes.  Background:  There is lack of evidence on the utility of complementary therapies in the management of constipation among older adults.  Design:  Quasi-experimental.  Methods:  A total of 90 participants from two nursing homes in Taiwan were assigned to three groups: the control group (with laxatives only), group I (with laxatives and abdominal massage) and group II (with laxatives, acupoint pressure therapy [APT] and abdominal massage). The intervention was performed over 10 days. A double-blind technique was applied in both participants and the outcome assessors. Constipation as main outcome was evaluated and recorded for 10 days. Observation of the frequency of defecation and the consistency, particularly firmness of faeces over each 24 h' period was recorded. The Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist was utilised in reporting methods and findings.  Results:  Three variations were revealed as interface factors and showed significant differences in each group. The results showed a statistically significant decrease in constipation in the experimental groups I and II. The scores of defecation frequency, difficulty degree and time of defecation, stool quality and awareness of defecation were obviously improved after treatment.  Conclusions:  We concluded APT could be used in conjunction with laxatives and must be considered as a long-term intervention. The combination of APT, abdominal massage and laxatives is superior to both abdominal massage with laxatives and laxatives alone.  Relevance to clinical practice:  Acupoint pressure as an effective complementary therapy of constipation among older adults living in nursing home provides a non-pharmacological, independent nursing intervention that nurses could use. This is relevant to nursing home settings where nurses make autonomous decision on important clinical assessments and interventions.",2020,"To compare the differences between acupoint pressure, abdominal massage and laxatives in treatment of constipation for residents in two nursing homes.  ","['older adults', 'older adults living in nursing home', '90 participants from two nursing homes in Taiwan', 'constipation for residents in two nursing homes', 'older people with constipation in nursing homes']","['Acupoint pressure', 'acupoint pressure', 'control group (with laxatives only), group I (with laxatives and abdominal massage) and group II (with laxatives, acupoint pressure therapy [APT] and abdominal massage', 'acupoint pressure, abdominal massage and laxatives']","['scores of defecation frequency, difficulty degree and time of defecation, stool quality and awareness of defecation', 'constipation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",90.0,0.0311967,"To compare the differences between acupoint pressure, abdominal massage and laxatives in treatment of constipation for residents in two nursing homes.  ","[{'ForeName': 'Mu-Hsing', 'Initials': 'MH', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, B41, R116, Northfields Avenue, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Hui Chen Rita', 'Initials': 'HCR', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, B41, R116, Northfields Avenue, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Megan F', 'Initials': 'MF', 'LastName': 'Liu', 'Affiliation': 'School of Gerontology Health Management, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, B41, R116, Northfields Avenue, Wollongong, NSW 2522, Australia.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Montayre', 'Affiliation': 'School of Nursing and Midwifery, Western Sydney University, Campbelltown Campus, Buidling 7.G. 11 Locked Bag 1797, Penrith, NSW 2751 Australia.'}]",Contemporary nurse,['10.1080/10376178.2020.1813042']
1905,32814500,"A quasi-experimental study examining QR code-based video education program on anxiety, adherence, and satisfaction in coronary angiography patients.","Background:  QR (quick response) codes are a promising tool for health education, however effects of QR code application in providing peri-procedure education to patients with coronary angiography is unclear.  Aim/Objective:  This study investigated the effect of a QR code-based video education program on anxiety, adherence, and satisfaction in Chinese coronary angiography patients.  Material and Methods:  This prospective controlled clinical trial included 335 patients undergoing coronary angiography, including 166 patients in the experimental group and 169 patients in the control group. On the day before coronary angiography, patients in the experimental group had access to and could watch an educational video on their smartphones by scanning a QR code for multiple times, while patients in the control group watched the same video on a tablet once only. The primary outcome was anxiety assessed using the Chinese State Anxiety Inventory (C-SAI). Adherence to instructions and patient satisfaction with the information delivery method were also evaluated.  Results:  The C-SAI scores improved in the experimental group compared to the control group ( F  = 9.8,  P  < 0.001) over time. There is a significant difference in the changes of anxiety scores from baseline to pre-procedure ( P  < 0.001) and post-procedure ( P  < 0.01) between the two groups. Individuals in the experimental group showed better adherence to instructions on removing dentures and jewelry, and taking medicines before the procedure ( P  < 0.05), and limb activity, water consumption, and diet after the procedure ( P  < 0.001).  Conclusion:  Patient education programs on smartphone that can be accessed multiple times by scanning a QR code can be an effective and convenient approach to reducing anxiety and enhancing adherence to instructions among Chinese coronary angiography patients. Hospitals and clinicians should consider more investments in developing such patient education programs and also help improve ehealth literacy.",2020,"Individuals in the experimental group showed better adherence to instructions on removing dentures and jewelry, and taking medicines before the procedure ( P <0.05), and limb activity, water consumption, and diet after the procedure ( P <0.001).  ","['335 patients undergoing coronary angiography, including 166 patients in the experimental group and 169 patients in the control group', 'coronary angiography patients', 'Chinese coronary angiography patients']","['QR code-based video education program', 'QR code-based Video education program']","['C-SAI scores', 'anxiety, adherence, and satisfaction', 'limb activity, water consumption, and diet', 'adherence to instructions on removing dentures and jewelry, and taking medicines', 'anxiety assessed using the Chinese State Anxiety Inventory (C-SAI', 'anxiety and adherence and satisfaction', 'anxiety scores', 'QR (quick response']","[{'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0455015', 'cui_str': 'Removing dentures'}, {'cui': 'C0336902', 'cui_str': 'Jewelry'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]",335.0,0.0541309,"Individuals in the experimental group showed better adherence to instructions on removing dentures and jewelry, and taking medicines before the procedure ( P <0.05), and limb activity, water consumption, and diet after the procedure ( P <0.001).  ","[{'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ""Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""Clinical Research Center, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Eye Institute, Xi'an City First Hospital, Xi'an, People's Republic of China.""}]",Contemporary nurse,['10.1080/10376178.2020.1813043']
1906,32814506,The effect of calcium co-ingestion on exogenous glucose oxidation during endurance exercise in healthy men: A pilot study.,"The benefits of high exogenous glucose availability for endurance exercise performance are well-established. Exogenous glucose oxidation rates are thought to be limited by intestinal glucose transport. Extracellular calcium in rodent intestine increases the translocation of the intestinal glucose transporter GLUT2 which, if translated to humans, could increase the capacity for exogenous glucose availability during exercise. Therefore, this pilot study aimed to explore the effect of calcium co-ingestion during endurance exercise on exogenous glucose oxidation in healthy men. Eight healthy men cycled for 2 h at 50% peak power output, ingesting either 1.2 g min -1  dextrose alone (GLU) or with the addition of 2000 mg calcium (GLU + CAL), in a randomised crossover design. Expired breath samples were collected to determine whole-body and exogenous glucose oxidation. Peak exogenous glucose oxidation during GLU was 0.83 ± 0.15 g min -1 , and was not enhanced during GLU + CAL (0.88 ± 0.11 g min -1 ,  p  = 0.541). The relative contributions of exogenous carbohydrate (19 ± 3% vs. 20 ± 2%,  p  = 0.434), endogenous carbohydrate (65 ± 3% vs. 65 ± 3%,  p  = 0.822) and fat (16 ± 3% vs. 15 ± 3%,  p  = 0.677) to total substrate utilisation did not differ between trials. These results suggest the addition of calcium to glucose ingestion, at saturating glucose ingestion rates, does not appear to alter exogenous glucose oxidation during endurance exercise in healthy men.  Highlights  Exogenous glucose oxidation rates during exercise are thought to be limited by intestinal glucose absorption. Previous work has suggested that calcium may facilitate GLUT2 translocation in rodent intestine, revealing the possibility that calcium could enhance intestinal glucose absorption. Data from the present study suggest that, in humans, ingesting calcium alongside glucose at saturating glucose absorption rates, does not enhance exogenous glucose oxidation rates during exercise.",2020,"The relative contributions of exogenous carbohydrate (19±3% vs. 20±2%,  p  = 0.434), endogenous carbohydrate (65±3% vs. 65±3%,  p  = 0.822) and fat (16±3% vs. 15±3%,  p  = 0.677) to total substrate utilisation did not differ between trials.","['Eight healthy men cycled for 2 h at 50% peak power output, ingesting either 1.2', 'healthy men']","['g·min -1  dextrose alone (GLU) or with the addition of 2000 mg calcium (GLU+CAL', 'calcium co-ingestion during endurance exercise', 'calcium co-ingestion']","['endogenous carbohydrate', 'Exogenous glucose oxidation rates', 'total substrate utilisation', 'exogenous glucose oxidation', 'relative contributions of exogenous carbohydrate', 'Peak exogenous glucose oxidation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",,0.0542746,"The relative contributions of exogenous carbohydrate (19±3% vs. 20±2%,  p  = 0.434), endogenous carbohydrate (65±3% vs. 65±3%,  p  = 0.822) and fat (16±3% vs. 15±3%,  p  = 0.677) to total substrate utilisation did not differ between trials.","[{'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Narang', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1813336']
1907,32847040,"Development and Implementation of a ""Music Beeps"" Program to Promote Physical Fitness in Adolescents.","This study aimed to develop a physical education fitness program for adolescents to counteract the declining physical activity levels caused by the COVID-19 pandemic, as well as to investigate the program's effect. This mixed-methods study developed and implemented a five-component ""Music Beeps"" (MB) program to promote adolescents' physical fitness. A total of 240 students from two high schools in South Korea-divided into experimental and control groups-participated in 32 sessions over 16 weeks. The changes in students' fitness were analyzed, and the educational effects were examined via inductive analysis of the observation logs and group and in-depth interviews. The results demonstrated that, whereas the comparison group demonstrated no statistically significant changes in power, muscular strength and endurance, or cardiopulmonary endurance, the experimental group showed changes in all these variables, along with changes in flexibility. Further, the MB program had significant educational effects. First, students reported that musical cues enhanced their fitness motivation and sense of responsibility. Second, record-keeping and active participation contributed to self-led fitness management. Third, activity in a small space with few pieces of equipment led to the positive perception that the program was efficient and enabled regular exercise regardless of climate conditions.",2020,"The results demonstrated that, whereas the comparison group demonstrated no statistically significant changes in power, muscular strength and endurance, or cardiopulmonary endurance, the experimental group showed changes in all these variables, along with changes in flexibility.","['Adolescents', '240 students from two high schools in South Korea-divided into experimental and control groups-participated in 32 sessions over 16 weeks']","['Music Beeps"" Program', 'physical education fitness program', 'five-component ""Music Beeps"" (MB) program']","['fitness motivation and sense of responsibility', 'power, muscular strength and endurance, or cardiopulmonary endurance', 'physical activity levels', 'flexibility']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",240.0,0.0155391,"The results demonstrated that, whereas the comparison group demonstrated no statistically significant changes in power, muscular strength and endurance, or cardiopulmonary endurance, the experimental group showed changes in all these variables, along with changes in flexibility.","[{'ForeName': 'Hyun-Chul', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Physical Education, Jeonbuk National University High School, Jeollabuk-do 54869, Korea.'}, {'ForeName': 'Eui-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, Baek Seok High School, Goyang-si 10416, Korea.'}, {'ForeName': 'Hyun-Su', 'Initials': 'HS', 'LastName': 'Youn', 'Affiliation': 'Department of Physical Education, College of Education, Won Kwang University, Iksan-si 54538, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17176148']
1908,32852904,Mepivacaine versus Bupivacaine Spinal Anesthesia for Early Postoperative Ambulation.,"BACKGROUND


Early ambulation after total hip arthroplasty predicts early discharge. Spinal anesthesia is preferred by many practices but can delay ambulation, especially with bupivacaine. Mepivacaine, an intermediate-acting local anesthetic, could enable earlier ambulation than bupivacaine. This study was designed to test the hypothesis that patients who received mepivacaine would ambulate earlier than those who received hyperbaric or isobaric bupivacaine for primary total hip arthroplasty.
METHODS


This randomized controlled trial included American Society of Anesthesiologists Physical Status I to III patients undergoing primary total hip arthroplasty. The patients were randomized 1:1:1 to 52.5 mg of mepivacaine, 11.25 mg of hyperbaric bupivacaine, or 12.5 mg of isobaric bupivacaine for spinal anesthesia. The primary outcome was ambulation between 3 and 3.5 h. Secondary outcomes included return of motor and sensory function, postoperative pain, opioid consumption, transient neurologic symptoms, urinary retention, intraoperative hypotension, intraoperative muscle tension, same-day discharge, length of stay, and 30-day readmissions.
RESULTS


Of 154 patients, 50 received mepivacaine, 53 received hyperbaric bupivacaine, and 51 received isobaric bupivacaine. Patient characteristics were similar among groups. For ambulation at 3 to 3.5 h, 35 of 50 (70.0%) of patients met this endpoint in the mepivacaine group, followed by 20 of 53 (37.7%) in the hyperbaric bupivacaine group, and 9 of 51 (17.6%) in the isobaric bupivacaine group (P < 0.001). Return of motor function occurred earlier with mepivacaine. Pain and opioid consumption were higher for mepivacaine patients in the early postoperative period only. For ambulatory status, 23 of 50 (46.0%) of mepivacaine, 13 of 53 (24.5%) of hyperbaric bupivacaine, and 11 of 51 (21.5%) of isobaric bupivacaine patients had same-day discharge (P = 0.014). Length of stay was shortest in mepivacaine patients. There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
CONCLUSIONS


Mepivacaine patients ambulated earlier and were more likely to be discharged the same day than both hyperbaric bupivacaine and isobaric bupivacaine patients. Mepivacaine could be beneficial for outpatient total hip arthroplasty candidates if spinal is the preferred anesthesia type.
EDITOR’S PERSPECTIVE


",2020,"There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
","['154 patients, 50 received', 'American Society of Anesthesiologists Physical Status I to III patients undergoing primary total hip arthroplasty', 'Early Postoperative Ambulation', 'for primary total hip arthroplasty', '154 patients, more individuals in the mepivacaine spinal group ambulated 3 to 3.5 h after injection than did individuals in either the']","['bupivacaine', 'mepivacaine, 11.25 mg of hyperbaric bupivacaine', 'isobaric bupivacaine', 'hyperbaric bupivacaine', 'Bupivacaine Spinal Anesthesia', 'isobaric or hyperbaric bupivacaine groupLikewise', 'mepivacaine', 'Mepivacaine', 'hyperbaric or isobaric bupivacaine']","['ambulation', 'return of motor and sensory function, postoperative pain, opioid consumption, transient neurologic symptoms, urinary retention, intraoperative hypotension, intraoperative muscle tension, same-day discharge, length of stay, and 30-day readmissions', 'transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness', 'same-day discharge', 'Length of stay', 'Pain and opioid consumption']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C4517532', 'cui_str': '11.25'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",154.0,0.121315,"There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Schwenk', 'Affiliation': ''}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Kasper', 'Affiliation': ''}, {'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Smoker', 'Affiliation': ''}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Mendelson', 'Affiliation': ''}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Austin', 'Affiliation': ''}, {'ForeName': 'Scot A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hozack', 'Affiliation': ''}, {'ForeName': 'Alexa J', 'Initials': 'AJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Wahal', 'Affiliation': ''}, {'ForeName': 'Jaime L', 'Initials': 'JL', 'LastName': 'Baratta', 'Affiliation': ''}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Torjman', 'Affiliation': ''}, {'ForeName': 'Alyson C', 'Initials': 'AC', 'LastName': 'Nemeth', 'Affiliation': ''}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Czerwinski', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003480']
1909,32853559,"Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.
METHODS


MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024.
FINDINGS


Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups.
INTERPRETATION


Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.
FUNDING


UK National Institute for Health Research Health Technology Assessment Programme.",2020,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","['2595 women were identified as being eligible for the MifeMiso trial', '59 (17%) of 348 women in the', '696 (98%) of 711 women had available data for the primary outcome', 'Women with missed miscarriage', '354 women', 'Between Oct 3, 2017, and July 22, 2019', '28 UK hospitals', '62 (17%) of 355 women in the', 'maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre', 'missed miscarriage (MifeMiso', '711 women', 'Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent']","['mifepristone and misoprostol', 'mifepristone plus misoprostol', 'Mifepristone and misoprostol', 'prostaglandin misoprostol', 'misoprostol', 'mifepristone', 'placebo', 'placebo and misoprostol', 'placebo plus misoprostol', 'oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol']","['chance of successful miscarriage management', 'failure to spontaneously pass the gestational sac', 'surgical intervention', 'incidence of adverse events', 'gestational sac spontaneously', 'rate of completion of missed miscarriage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}, {'cui': 'C0069304', 'cui_str': 'POU5F1 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0948766', 'cui_str': 'Ultrasound pelvis'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1126026', 'cui_str': 'Mifepristone 200 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0000814', 'cui_str': 'Missed miscarriage'}]",2595.0,0.70251,"62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021).","[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Chu', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Devall', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. Electronic address: a.j.devall@bham.ac.uk.'}, {'ForeName': 'Leanne E', 'Initials': 'LE', 'LastName': 'Beeson', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'C Okeke', 'Initials': 'CO', 'LastName': 'Ogwulu', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Jones', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jenny H', 'Initials': 'JH', 'LastName': 'La Fontaine Papadopoulos', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bender-Atik', 'Affiliation': 'The Miscarriage Association, Wakefield, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's Charity, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Choudhary', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Sunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Naftalin', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nunes', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster NHS Foundation Trust, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': ""St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.""}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Izzat', 'Affiliation': 'University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Kalsang', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Hassan', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Yadava', 'Initials': 'Y', 'LastName': 'Jeve', 'Affiliation': ""Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': ""Guy's and St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ""Kings College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Watkins', 'Affiliation': ""Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Princess Royal Hospital, Shrewsbury and Telford NHS Trust, Telford, UK.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Department of Reproductive Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Chitra S', 'Initials': 'CS', 'LastName': 'Kumar', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Small', 'Affiliation': 'Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Pringle', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hodge', 'Affiliation': 'Singleton Hospital, Swansea Bay University Health Board, Swansea, UK.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Ioannis D', 'Initials': 'ID', 'LastName': 'Gallos', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick, UK.'}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31788-8']
1910,32853783,Coffee consumption for recovery of intestinal function after laparoscopic gynecological surgery: A randomized controlled trial.,"BACKROUND


To investigate the effect of postoperative coffee consumption on bowel motility after laparoscopic gynecological surgery.
MATERIALS AND METHODS


In this randomized controlled trial, patients were allocated postoperatively to 3 cups of either coffee or warm water at 6, 12, or 18 h after the operation. Total hysterectomy and bilateral salpingectomy were performed on all patients. In addition, a salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy were performed according to clinical indications. The primary endpoint was time to the first passage of flatus after surgery.
RESULTS


A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water). The median time to flatus (19 [13-35] vs. 25 [15-42] h; hazard ratio [HR] 1.9, 95% confidence interval [CI], 1.2-2.9; P = 0.0009), median time to defecation (30 [22-54] vs. 38 [26-65] h, HR 2.4, 95% CI, 1.5-3.8; P < 0.0001), and mean time to tolerate food (2 [2-5] vs. 3 [2-8] days, HR 1.5, 95% CI, 1.02-2.3; P = 0.002) were decreased significantly in patients who consumed coffee compared with the control subjects. Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02). No adverse events were attributed to coffee consumption.
CONCLUSION


Postoperative coffee intake after laparoscopic gynecological surgery hastened the recovery of gastrointestinal function by reducing the time to the first passage of flatus, time to the first defecation, and time to tolerate a solid diet. This simple, cheap, and well-tolerated treatment merits routine use alongside other existing enhanced recovery pathways in the postoperative setting.",2020,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"['A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water', 'after laparoscopic gynecological surgery']","['salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy', 'Coffee consumption', 'postoperative coffee consumption']","['mean time to tolerate food', 'intestinal function', 'Total hysterectomy and bilateral salpingectomy', 'adverse events', 'bowel motility', 'time to the first passage of flatus after surgery', 'Postoperative ileus', 'recovery of gastrointestinal function', 'median time to flatus', 'median time to defecation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0036132', 'cui_str': 'Salpingo-oophorectomy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C0195509', 'cui_str': 'Bilateral complete salpingectomy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",96.0,0.115899,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Gungorduk', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey. Electronic address: drkemalgungorduk@gmail.com.'}, {'ForeName': 'Ezgi Karakas', 'Initials': 'EK', 'LastName': 'Paskal', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Demirayak', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sezen Bozkurt', 'Initials': 'SB', 'LastName': 'Köseoğlu', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Akbaba', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Isa Aykut', 'Initials': 'IA', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.016']
1911,32853919,Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®).,"OBJECTIVE


To validate automatic sleep stage classification using deep neural networks on sleep assessed by radar technology in the commercially available sleep assistant Somnofy® against polysomnography (PSG).
METHODS


Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions. The Somnofy unit was placed in two different locations per room (nightstand and wall). The sleep algorithm was validated against PSG using a 25-fold cross validation technique, and performance was compared to the inter-rater reliability between the PSG sleep scored by two independent sleep specialists.
RESULTS


Epoch-by-epoch analyses showed a sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake) for Somnofy of 0.97 and 0.72 respectively, compared to 0.99 and 0.85 for the PSG scorers. The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96. The intraclass correlation coefficient revealed excellent and good reliability for total sleep time and sleep efficiency, while sleep onset and R latency had poor agreement. Somnofy underestimated total wake time by 5 min and N1/N2 by 3 min. N3 was overestimated by 4 min and R by 3 min. Results were independent of institution and sensor location.
CONCLUSION


Somnofy showed a high accuracy staging sleep in healthy individuals and has potential to assess sleep quality and quantity in a sample of healthy, mostly young adults. More research is needed to examine performance in children, older individuals and those with sleep disorders.",2020,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","['children, older individuals and those with sleep disorders', 'Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions', 'healthy individuals']",['non-contact radar technology and machine learning (Somnofy®'],"['sleep stage differentiation', 'total wake time', 'accuracy staging sleep', 'total sleep time and sleep efficiency', 'sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0201471,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","[{'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Toften', 'Affiliation': 'Department of Data Science, VitalThings AS, Tønsberg, Norway. Electronic address: st@vitalthings.com.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway; Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hrozanova', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Moen', 'Affiliation': 'Department of Education and Lifelong Learning, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.022']
1912,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
1913,32854052,Does symptom severity matter in stepped and collaborative care for depression?,"BACKGROUND


We investigated the differential effectiveness of a stepped and collaborative care model (SCM) vs. treatment as usual (TAU) for primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments.
METHODS


Subgroup analyses of a RCT were calculated applying a multiple linear mixed model with the factors 1. group (SCM; TAU), 2. severity ((mild-moderate (MMD); severe depression (SD)) and their interaction, with PHQ-9 as primary outcome. Utilization of treatments was analyzed descriptively.
RESULTS


For the 737 participating patients (SCM: n = 569; TAU: n = 168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70%. ITT-analysis (Last-observation-carried-forward) revealed a significant interaction for group x severity [p = 0.036] and a significant difference between groups in symptom reduction for MMD (-3.9; [95% CI: -5.1 to -2.6, p < 0.001; d = 0.64] but not for SD (-1.6; [95% CI: -3.4 to 0.2, p = 0.093; d = 0.27]. Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD. Differences between SCM and TAU in the percentage of patients utilizing depression-specific treatments are larger for MMD.
LIMITATIONS


There was a high proportion of missing values among severely depressed patients, especially in SCM.
CONCLUSION


SCM is effective for both MMD and SD. Utilization patterns might help explain the higher effects for MMD. Various strategies of replacement of missing values lead to slightly divergent results due to selective drop out between severity groups.",2020,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","['primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments', '737 participating patients (SCM: n\xa0=\xa0569; TAU: n\xa0=\xa0168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70']","['SCM', 'SCM and TAU', 'stepped and collaborative care model (SCM) vs. treatment as usual (TAU']",['severity ((mild-moderate (MMD); severe depression (SD'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}]",737.0,0.0676647,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Watzke', 'Affiliation': 'Clinical Psychology and Psychotherapy Research, Institute of Psychology, University of Zurich, Binzmühlestrasse 14/16, CH-8050 Zurich, Switzerland. Electronic address: birgit.watzke@uzh.ch.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: d.heddaeus@uke.de.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Steinmann', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.steinmann@uke.de.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: a.daubmann@uke.de.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: k.wegscheider@uke.uni-hamburg.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.haerter@uke.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.079']
1914,32854984,Effect of information format on intentions and beliefs regarding diagnostic imaging for non-specific low back pain: A randomised controlled trial in members of the public.,"OBJECTIVE


To evaluate the effects of information format on intentions to request diagnostic imaging for non-specific low back pain in members of the public.
METHODS


We performed a three arm, 1:1:1, superiority randomised trial on members of the public. Participants were randomised to one of the three groups: a Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging). Our primary outcome was intention to request imaging for low back pain.
RESULTS


418 participants were randomised. After reading the leaflet, intention to request imaging (measured on an 11-point scale (0 = definitely would not request to 10 = definitely would request) was lower in the Nudge Leaflet group (mean = 4.6, SD = 3.4) compared with the Standard Care Leaflet group (mean = 5.3, SD = 3.3) and the Neutral Leaflet group (mean = 5.3, SD = 3.0) (adjusted mean difference between Nudge and Neutral, -1.0 points, 95%CI -1.6 to -0.4).
CONCLUSION


Framing information to emphasise potential harms from overdiagnosis reduced intention to request diagnostic imaging for low back pain.
PRACTICE IMPLICATIONS


Nudge leaflets could help clinicians manage patient pressure for unnecessary tests.",2020,"Participants were randomised to one of the three groups: a Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging).","['members of the public', 'non-specific low back pain', 'non-specific low back pain in members of the public', '418 participants were randomised']","['Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging', 'information format']",['intention to request imaging for low back pain'],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",418.0,0.226026,"Participants were randomised to one of the three groups: a Standard Care Leaflet group (standard information on low back pain), a Neutral Leaflet group (balanced information on the benefits and harms of imaging) and a Nudge Leaflet group (with behavioural cues to emphasise the harms of unnecessary imaging).","[{'ForeName': 'Sweekriti', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia. Electronic address: sweekriti.sharma@sydney.edu.au.'}, {'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Traeger', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Copp', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Winton Centre for Risk and Communication, Centre for Mathematical Sciences, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Faculty of Health Sciences and Medicine, Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.021']
1915,32821939,Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.,"Importance


Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown.
Objective


To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment.
Design, Setting, and Participants


Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020.
Interventions


Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d.
Main Outcomes and Measures


The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group.
Results


Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.
Conclusions and Relevance


Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.
Trial Registration


ClinicalTrials.gov Identifier: NCT04292730.",2020,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"['patients with moderate COVID-19', '94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia', '596 patients who were randomized', 'Patients With Moderate COVID-19', 'hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation', 'patients with severe coronavirus disease 2019 (COVID-19', ' 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial']","['Remdesivir vs Standard Care', 'remdesivir treatment', 'placebo']","['headache', 'Nausea', 'clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7', 'hypokalemia', 'clinical status distribution', 'Median length of treatment', 'clinical status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.105766,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"[{'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Arribas López', 'Affiliation': 'Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cattelan', 'Affiliation': 'Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Soriano Viladomiu', 'Affiliation': 'Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Onyema', 'Initials': 'O', 'LastName': 'Ogbuagu', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': 'North Shore University Hospital, Manhasset, New York.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Louis Yi Ann', 'Initials': 'LYA', 'LastName': 'Chai', 'Affiliation': 'National University Health System, Singapore.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Owen Tak Yin', 'Initials': 'OTY', 'LastName': 'Tsang', 'Affiliation': 'Princess Margaret Hospital, Hong Kong, China.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Le Turnier', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'Shan-Chwen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anu O', 'Initials': 'AO', 'LastName': 'Osinusi', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'McPhail', 'Affiliation': ""King's College, London, England.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Bhagani', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Ahn', 'Affiliation': 'Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.16349']
1916,32817632,Evaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial.,"BACKGROUND


The World Health Organization has yet to endorse deployment of topical repellents for malaria prevention as part of public health campaigns. We aimed to quantify the effectiveness of repellent distributed by the village health volunteer (VHV) network in the Greater Mekong Subregion (GMS) in reducing malaria in order to advance regional malaria elimination.
METHODS AND FINDINGS


Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks) to test the effectiveness of 12% N,N-diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp. infection. The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40%). No adverse events were reported during the study. Generalised linear mixed modelling estimated the effect of repellent on infection detected by rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR) (secondary outcome). Overall Plasmodium infection detected by RDT was low (0.16%; 50/32,194), but infection detected by PCR was higher (3%; 419/13,157). There was no significant protection against RDT-detectable infection (adjusted odds ratio [AOR] = 0.25, 95% CI 0.004-15.2, p = 0.512). In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233). Repellent effects were similar when delayed effects were modelled, across risk groups, and regardless of village-level and temporal heterogeneity in malaria prevalence. The incremental cost-effectiveness ratio was US$256 per PCR-detectable infection averted. Study limitations were a lower than expected Plasmodium spp. infection rate and potential geographic dilution of the intervention.
CONCLUSIONS


In this study, we observed apparent protection against new infections associated with the large-scale distribution of repellent by VHVs. Incorporation of repellent into national strategies, particularly in areas where bed nets are less effective, may contribute to the interruption of malaria transmission. Further studies are warranted across different transmission settings and populations, from the GMS and beyond, to inform WHO public health policy on the deployment of topical repellents for malaria prevention.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry (ACTRN12616001434482).",2020,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","['infection in Myanmar', 'Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks', 'village health volunteer networks against\xa0Plasmodium spp', 'The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40']","['diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp', 'village health volunteer (VHV) network in the Greater Mekong Subregion (GMS']","['infection rate and potential geographic dilution', 'protection against RDT-detectable infection', 'rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR', 'incremental cost-effectiveness ratio', 'adverse events', 'Overall Plasmodium infection']","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086312', 'cui_str': 'Forest'}]","[{'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",,0.250486,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Agius', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Cutts', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Han Oo', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Thi', 'Affiliation': 'Department of Public Health, Myanmar Ministry of Health and Sports, Nay Pyi Taw, Myanmar.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': ""O'Flaherty"", 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Kyaw', 'Initials': 'K', 'LastName': 'Zayar Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Htin', 'Initials': 'H', 'LastName': 'Kyaw Thu', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Poe', 'Initials': 'P', 'LastName': 'Poe Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Myat', 'Initials': 'M', 'LastName': 'Mon Thein', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Nyi', 'Initials': 'N', 'LastName': 'Nyi Zaw', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Yan Min Htay', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Paing Soe', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Razook', 'Affiliation': 'Population Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alyssa E', 'Initials': 'AE', 'LastName': 'Barry', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Htike', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendan S', 'Initials': 'BS', 'LastName': 'Crabb', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Naanki', 'Initials': 'N', 'LastName': 'Pasricha', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Freya J I', 'Initials': 'FJI', 'LastName': 'Fowkes', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}]",PLoS medicine,['10.1371/journal.pmed.1003177']
1917,32817638,Correction: A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults.,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,['well-trained middle and older-aged adults'],['nitrate supplementation'],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],,0.0815607,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': ''}, {'ForeName': 'Macie S', 'Initials': 'MS', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'Caleb G', 'Initials': 'CG', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Gauthier', 'Affiliation': ''}, {'ForeName': 'Summer L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': ''}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Heinrich', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238271']
1918,32826784,Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.,"BACKGROUND


Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP).
OBJECTIVE


Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care.
METHODS


Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon.
RESULTS


Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was ""dominant"" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost.
DISCUSSION/CONCLUSIONS


Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.",2020,Negligible differences in health care costs were found between groups.,"['Veterans', 'military veterans with cLBP', 'Participants (n=150', 'persons with chronic low back pain (cLBP']",[],"['Roland-Morris Disability Questionnaire', 'Health care costs', 'pain and disability', 'EQ-5D scale', 'health care costs', 'Quality-adjusted life years (QALYs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",150.0,0.0429254,Negligible differences in health care costs were found between groups.,"[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Richard', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Tally', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}]",Medical care,['10.1097/MLR.0000000000001356']
1919,32822347,Safety and parasite clearance of artemisinin-resistant Plasmodium falciparum infection: A pilot and a randomised volunteer infection study in Australia.,"BACKGROUND


Artemisinin resistance is threatening malaria control. We aimed to develop and test a human model of artemisinin-resistant (ART-R) Plasmodium falciparum to evaluate the efficacy of drugs against ART-R malaria.
METHODS AND FINDINGS


We conducted 2 sequential phase 1, single-centre, open-label clinical trials at Q-Pharm, Brisbane, Australia, using the induced blood-stage malaria (IBSM) model, whereby healthy participants are intravenously inoculated with blood-stage parasites. In a pilot study, participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites. In a comparative study, participants were randomised to receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1). In both studies, participants were administered a single approximately 2 mg/kg oral dose of artesunate (AS; Day 9). Primary outcomes were safety, ART-R parasite infectivity, and parasite clearance. In the pilot study, 2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years]). In the comparative study, 25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years]). In both studies, all participants inoculated with ART-R parasites became parasitaemic. A total of 36 adverse events were reported in the pilot study and 277 in the comparative study. Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious. Seven participants experienced transient severe falls in white cell counts and/or elevations in liver transaminase levels which were considered related to malaria. Additionally, 2 participants developed ventricular extrasystoles that were attributed to unmasking of a predisposition to benign fever-induced tachyarrhythmia. In the comparative study, parasite clearance half-life after AS was significantly longer for ART-R infected participants (n = 13, 6.5 hours; 95% confidence interval [CI] 6.3-6.7 hours) compared with ART-S infected participants (n = 9, 3.2 hours; 95% CI 3.0-3.3 hours; p < 0.001). The main limitation of this study was that the ART-R and ART-S parasite strains did not share the same genetic background.
CONCLUSIONS


We developed the first (to our knowledge) human model of ART-R malaria. The delayed clearance profile of ART-R parasites after AS aligns with field study observations. Although based on a relatively small sample size, results indicate that this model can be safely used to assess new drugs against ART-R P. falciparum.
TRIAL REGISTRATION


The studies were registered with the Australian New Zealand Clinical Trials Registry: ACTRN12617000244303 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372357) and ACTRN12617001394336 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373637).",2020,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","['healthy participants are intravenously inoculated with blood-stage parasites', '25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years', 'participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites', 'volunteer infection study in Australia', '2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years']","['receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1', 'artemisinin-resistant Plasmodium falciparum infection']","['ventricular extrasystoles', 'delayed clearance profile of ART-R parasites', 'headache, pyrexia, myalgia, nausea, and chills', 'safety, ART-R parasite infectivity, and parasite clearance', 'liver transaminase levels', 'transient severe falls']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}]","[{'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030657', 'cui_str': 'pathogenicity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",2.0,0.271382,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Watts', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Odedra', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marquart', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Azrin N', 'Initials': 'AN', 'LastName': 'Abd-Rahman', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cascales', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Zuleima', 'Initials': 'Z', 'LastName': 'Pava', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cielo', 'Initials': 'C', 'LastName': 'Pasay', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Peatey', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Jörg J', 'Initials': 'JJ', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McCarthy', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003203']
1920,32822650,Multisite Randomized Controlled Trial of Bladder Management in Labor With Epidural Analgesia/Anesthesia.,"OBJECTIVE


To compare the effects of continuous indwelling catheterization with those of intermittent catheterization during labor with epidural analgesia/anesthesia on mode of birth and incidence of urinary tract infection (UTI) symptoms in the postpartum period.
DESIGN


Randomized clinical trial.
SETTING


Labor and delivery units at three metropolitan hospitals in the Western United States.
PARTICIPANTS


Women (N = 252) who were nulliparous with term, singleton pregnancies in labor with epidural analgesia/anesthesia.
METHODS


Participants were randomized to indwelling or intermittent (every 2 hours) catheterization groups after the administration of epidural analgesia/anesthesia during labor. One to 2 weeks after discharge, participants were contacted and questioned about symptoms of UTI.
RESULTS


A total of 252 participants were enrolled in the study: 81% (n = 202) gave birth vaginally, and 19% (n = 50) gave birth via cesarean. Between the indwelling and intermittent catheterization groups, demographic characteristics were similar. We found no significant difference in the incidence of cesarean birth between groups (15.6% vs. 22.5%, p = .172). Overall, 3% of participants reported and sought treatment for symptoms of UTI within 2 weeks with no significant difference between groups (p = .929).
CONCLUSION


We found no differences in mode of birth or symptoms of UTI in women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia. We recommend additional research with objective data for UTI diagnosis and larger samples to study the multiple potential confounding variables associated with cesarean birth after catheterization during epidural analgesia/anesthesia.",2020,We found no differences in mode of birth or symptoms of UTI in women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia.,"['Labor', 'Labor and delivery units at three metropolitan hospitals in the Western United States', 'Women (N\xa0= 252) who were nulliparous with term, singleton pregnancies in labor with epidural analgesia/anesthesia', 'Participants', 'women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia', 'A total of 252 participants were enrolled in the study: 81%\xa0(n\xa0= 202) gave birth vaginally, and 19%\xa0(n\xa0= 50) gave birth via cesarean']","['Epidural Analgesia/Anesthesia', 'epidural analgesia/anesthesia during labor', 'epidural analgesia/anesthesia', 'Bladder Management', 'continuous indwelling catheterization']","['cesarean birth', 'mode of birth or symptoms of UTI', 'mode of birth and incidence of urinary tract infection (UTI) symptoms', 'incidence of cesarean birth']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1321138', 'cui_str': 'Labor and delivery unit'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1161197', 'cui_str': 'Bladder care assessment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.142303,We found no differences in mode of birth or symptoms of UTI in women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dempsey', 'Affiliation': ''}, {'ForeName': 'Cyndy', 'Initials': 'C', 'LastName': 'Krening', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vorgic', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2020.07.005']
1921,32822656,Physiology-guided revascularization versus optimal medical therapy of nonculprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial.,"BACKGROUND


Myocardial infarction (MI) in elderly patients is associated with unfavorable prognosis, and it is becoming an increasingly prevalent condition. The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD). Given the limited evidence available for elderly patients, it has not yet been established whether, as for younger patients, a complete revascularization strategy in MI patients with MVD should be advocated. We present the design of a dedicated study that will address this research gap.
METHODS AND DESIGN


The FIRE trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients aged 75 years and older, with MI (either STE or NSTE), MVD at coronary artery angiography, and a clear culprit lesion will be randomized to culprit-only treatment or to physiology-guided complete revascularization. The primary end point will be the patient-oriented composite end point of all-cause death, any MI, any stroke, and any revascularization at 1 year. The key secondary end point will be the composite of cardiovascular death and MI. Quality of life and physical performance will be evaluated as well. All components of the primary and key secondary outcome will be tested also at 3 and 5 years. The sample size for the study is 1,400 patients.
IMPLICATIONS


The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD to improve their clinical outcomes.",2020,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","['1400 patients', 'elderly patients with myocardial infarction', 'Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion', 'elderly patients']",['Physiology-guided revascularization versus optimal medical therapy'],"['patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year', 'composite of cardiovascular death and MI', 'Quality of life and physical performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0629355,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Biscaglia', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy. Electronic address: bscsmn@unife.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Amat Santos', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernandez-Aviles', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Lanzilotti', 'Affiliation': 'U.O.C. Cardiologia, Ospedale Maggiore, Largo Nigrisoli 2, Bologna, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Department of Cardiology, Infermi Hospital, Rivoli, Italy; Department of Cardiology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Fileti', 'Affiliation': 'Cardiology Department, S. Maria delle Croci Hospital, Viale Randi 5, Ravenna, Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Instituto de Investigación Hospital La Paz (IDIPAZ), University Hospital La Paz, Madrid, Spain, Madrid; Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giannini', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Iginio', 'Initials': 'I', 'LastName': 'Colaiori', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Menozzi', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ruozzi', 'Affiliation': 'Cardiology Unit, Ospedale Civile di Baggiovara, Modena, Italy.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gutiérrez Ibañes', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Díez Gil', 'Affiliation': 'Servicio de Cardiología, H. Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Calle del Prof Martin Lagos s/n, Madrid, Spain.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Via Pansini, Naples, Italy.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy; Institute of Cardiology, Jagiellonian University Medical College, ul. Sw Anny 12, Krakow, Poland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy; Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}]",American heart journal,['10.1016/j.ahj.2020.08.007']
1922,32822827,A community-based asthma program: Study design and methods of RVA Breathes.,"Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, asthma symptoms, and quality of life. We will enroll 300 elementary school children from the Richmond City Public School system. Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years. Participants will be randomized to one of three groups: asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition. Data will be collected across one baseline research visit, four intervention sessions, and four follow-up research visits over the course of 18 months. A General Linear Mixed Model (GLMM) will be used to test primary aims. We expect the findings will provide support for coordination of asthma care across sectors. Further, we hope RVA Breathes will serve as a model of community-based pediatric asthma care.",2020,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","['Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years', '300 elementary school children from the Richmond City Public School system']","['asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition', 'RVA']","['asthma control, asthma symptoms, and quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",300.0,0.0360733,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","[{'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Everhart', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America. Electronic address: reverhart@vcu.edu.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Holder', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Schechter', 'Affiliation': ""Children's Hospital of Richmond at VCU, Richmond, VA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106121']
1923,32822887,"Efficacy and Safety of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Operation for Gastrointestinal Malignancy in Japanese Patients: A Multicenter, Open-Label, Prospective, Randomized Controlled Trial.","BACKGROUND


The risk of venous thromboembolism (VTE) after surgery for malignancy in Japanese patients is unclear; therefore, standard prevention protocols have not been established, especially for minimally invasive procedures. We aimed to investigate the additional effect of low molecular weight heparin (LMWH) on prevention of VTE after laparoscopic surgery for gastrointestinal malignancy.
STUDY DESIGN


From February 2013 to January 2017, 400 patients scheduled for laparoscopic surgery were included. Cases were randomly allocated to the physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients), in which enoxaparin sodium (20 mg [= 2000 IU] twice a day) was administered for 1 week postoperatively in addition to the physical therapy. A diagnosis of VTE was made by contrast-enhanced CT or ultrasonography when symptomatic or D-dimer was ≥10 μg/mL.
RESULTS


VTE was observed in 1.2% and 4.0% of patients in the LMWH and Control groups, respectively (odds ratio [OR] 0.3, 95% confidence interval [CI] 0.03-1.53). Pulmonary embolism was confirmed only in the Control group (1.7%). No major bleeding occurred in either group. Logistic multiple regression analysis revealed that surgical time extension (OR 1.02, 95% CI 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR 0.21, 95% CI 0.03-0.99), male sex (OR 0.12, 95% CI 0.01-0.60), and early cancer (OR 0.17, 95% CI 0.02-0.82) reduced the risk of VTE.
CONCLUSIONS


Postoperative LMWH administration is safe. The additional effect of LMWH administration on the physical therapy was not statistically proven in this study. However, it could be useful for the patients with risk factors such as female sex, long operation time, and higher cancer stage.",2020,"Logistic multiple regression analysis revealed that surgical time extension (OR=1.02, 95%CI: 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR=0.21, 95%CI: 0.03-0.99), male sex (OR=0.12, 95%CI: 0.01-0.60), and early cancer (OR=0.17, 95%CI: 0.02-0.82) reduced the risk of VTE.
","['Japanese Patients', 'From February 2013 to January 2017, Four hundred patients scheduled for laparoscopic surgery were included', 'Japanese patients']","['LMWH', 'Low-Molecular-Weight Heparin', 'low-molecular-weight heparin (LMWH', 'physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients) in which enoxaparin sodium', 'Laparoscopic Operation']","['Pulmonary embolism', 'VTE', 'surgical time extension', 'major bleeding', 'risk of VTE', 'Venous Thromboembolism']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0724579', 'cui_str': 'Enoxaparin sodium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",400.0,0.0725743,"Logistic multiple regression analysis revealed that surgical time extension (OR=1.02, 95%CI: 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR=0.21, 95%CI: 0.03-0.99), male sex (OR=0.12, 95%CI: 0.01-0.60), and early cancer (OR=0.17, 95%CI: 0.02-0.82) reduced the risk of VTE.
","[{'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Obitsu', 'Affiliation': 'Departments of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Oyama', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, Sendai, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Surgery, South Miyagi Medical Center, Shibata-gun, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Departments of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics Tohoku University Graduate School of Medicine, Sendai, Japan; Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Takagi', 'Affiliation': 'Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Rikiyama', 'Affiliation': 'Departments of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Naitoh', 'Affiliation': 'Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: naitot@med.kitasato-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.08.734']
1924,32823733,No Effects of New Zealand Blackcurrant Extract on Physiological and Performance Responses in Trained Male Cyclists Undertaking Repeated Testing across a Week Period.,"Anthocyanin supplements are receiving attention due to purported benefits to physiological, metabolic, and exercise responses in trained individuals. However, the efficacy of anthocyanin intake over multiple testing days is not known. We compared a placebo and two doses of anthocyanin-rich New Zealand blackcurrant (NZBC) extract (300 and 600 mg·day -1 ) on plasma lactate, substrate oxidation, and 16.1 km time trial (TT) performance on three occasions over 7-days in a fed state (day 1 (D1), D4, and D7). Thirteen male cyclists participated in a randomized, crossover, placebo-controlled double-blind design. There was no difference in plasma lactate and substrate oxidation between conditions and between days. A time difference was observed between D1 (1701 ± 163 s) and D4 (1682 ± 162 s) for 600 mg ( p  = 0.05), with an increment in average speed (D1 = 34.3 ± 3.4 vs. D4 = 34.8 ± 3.4 km·h -1 ,  p  = 0.04). However, there was no difference between the other days and between conditions. Overall, one week of intake of NZBC extract did not affect physiological and metabolic responses. Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.",2020,Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.,"['Trained Male Cyclists', 'Thirteen male cyclists']","['New Zealand Blackcurrant Extract', 'Anthocyanin supplements', 'NZBC extract', 'anthocyanin-rich New Zealand blackcurrant (NZBC) extract', 'placebo']","['Physiological and Performance Responses', 'physiological and metabolic responses', 'plasma lactate, substrate oxidation, and 16.1 km time trial (TT) performance', 'plasma lactate and substrate oxidation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",13.0,0.300606,Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Montanari', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Mehmet A', 'Initials': 'MA', 'LastName': 'Şahin', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Sam D', 'Initials': 'SD', 'LastName': 'Blacker', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8080114']
1925,32827501,Intranasal vasopressin expedites dishonesty in women.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in men and women. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, women receiving intranasal AVP lied more than women receiving intranasal placebo and men receiving intranasal AVP. The dishonest behavior of women treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in women, contingent on the motivation of dishonesty. Our findings provide insight into gender-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
1926,32827517,"Ropinirole, a dopamine agonist with high D 3  affinity, reduces proactive inhibition: A double-blind, placebo-controlled study in healthy adults.","Response inhibition describes the cognitive processes mediating the suppression of unwanted actions. A network involving the basal ganglia mediates two forms of response inhibition: reactive and proactive inhibition. Reactive inhibition serves to abruptly stop motor activity, whereas proactive inhibition is goal-orientated and results in slowing of motor activity in anticipation of stopping. Due to its impairment in several psychiatric disorders, the neurochemistry of response inhibition has become of recent interest. Dopamine has been posed as a candidate mediator of response inhibition due to its role in functioning of the basal ganglia and the observation that patients with Parkinson's disease on dopamine agonists develop impulse control disorders. Although the effects of dopamine on reactive inhibition have been studied, substantial literature on the role of dopamine on proactive inhibition is lacking. To fill this gap, we devised a double-blind, placebo-controlled study of 1 mg ropinirole (a dopamine agonist) on response inhibition in healthy volunteers. We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo. To investigate how ropinirole mediated this effect on proactive inhibition, we used hierarchical drift-diffusion modelling. We found that ropinirole impaired the ability to raise the decision threshold when proactive inhibition was called upon. Our results provide novel evidence that an acute dose of ropinirole selectively reduces proactive inhibition in healthy participants. These results may help explain how ropinirole induces impulse control disorders in susceptible patients with Parkinson's disease.",2020,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[""susceptible patients with Parkinson's disease"", 'healthy volunteers', ""patients with Parkinson's disease on dopamine agonists develop impulse control disorders"", 'healthy adults', 'healthy participants']","['Dopamine', 'Ropinirole', 'ropinirole', 'ropinirole (a dopamine agonist', 'dopamine', 'placebo']","['reactive inhibition', 'proactive inhibition']","[{'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0021122', 'cui_str': 'Impulse control disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034750', 'cui_str': 'Inhibition, Reactive'}, {'cui': 'C0033199', 'cui_str': 'Inhibition, Proactive'}]",,0.116831,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Rawji', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK. Electronic address: vishal.rawji.11@ucl.ac.uk.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108278']
1927,32827709,Acute effect of inspiratory resistive loading on sprint interval exercise performance in team-sport athletes.,"This study examined acute effects of inspiratory resistive loading (IRL) during rest intervals on sprint interval exercise (SIE) performance. In a randomized crossover design, nine collegiate basketball players performed IRL (15 cmH 2 O) or passive recovery (CON) at 5-min rest intervals during and immediately after 6 sets of a 30-s SIE test. Performance, muscular oxygenation of vastus lateralis, blood lactate and pH were measured at each condition. Blood lactate at 5-min (-20.5 %) and 20-min (-21.3 %) after SIE were significantly lower in IRL than in CON. The pH at 5-min after SIE was significantly higher in IRL than in CON (+0.8 %, p <  0.05). However, the total work in IRL was significantly lower than in CON (-2.7 %, p <  0.05). Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5 %, p <  0.05). The IRL could attenuate exercise-induced metabolic acidosis; however, the decreased blood flow at rest intervals might increase the physical challenge in SIE.",2020,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).",['team-sport athletes'],"['inspiratory resistive loading (IRL', 'CON', 'inspiratory resistive loading', 'IRL (15\u2009cmH 2 O) or passive recovery (CON']","['sprint interval exercise performance', 'Blood lactate', 'IRL', 'sprint interval exercise (SIE) performance', 'total hemoglobin at rest intervals in IRL', 'blood flow', 'Performance, muscular oxygenation of vastus lateralis, blood lactate and pH', 'total work in IRL']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",,0.0174742,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).","[{'ForeName': 'Ching-Feng', 'Initials': 'CF', 'LastName': 'Cheng', 'Affiliation': 'Department of Athletic Performance, National Taiwan Normal University, Taipei, Taiwan; Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan. Electronic address: andescheng@ntnu.edu.tw.'}, {'ForeName': 'Wei-Chieh', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Graduate Institute of Sports Training, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Wei', 'Initials': 'TW', 'LastName': 'Chen', 'Affiliation': 'Physical Education Office, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103531']
1928,32831540,Laparoscopic Posterior Versus Lateral Transversus Abdominis Plane Block in Gynecology.,"Background and Objectives


Transversus abdominis plane (TAP) block is a safe and effective type of regional anesthesia technique used in laparoscopic gynecologic surgery to minimize postoperative pain. Our study aimed to compare the analgesic effects of the posterior versus lateral approaches to laparoscopic-assisted TAP block in minimally invasive gynecologic surgery.
Methods


We performed a randomized controlled trial with 82 patients allocated to either posterior (n = 38) or lateral (n = 44) TAP block groups. Laparoscopic-assisted posterior or lateral TAP block was administered using liposomal bupivacaine mixture. All subjects were asked to fill out a questionnaire, which included postoperative pain scores at 6 h, 12 h, 24 h, 48 h, and 72 h, as well as narcotic utilization postoperatively. Both groups were compared for postoperative pain scores, opioid consumption, perioperative, and demographic characteristics.
Results


A total of 67 patients were analyzed in our study (n = 33 in posterior arm, n = 34 in lateral arm). Demographic characteristics including race, body mass index, comorbidities, American Society of Anesthesiologists classification, pre-operative diagnosis, complication rates, length of stay, and estimated blood loss were comparable between the two groups. The distribution of different operative procedures was similar between the two groups. There was no statistically significant difference in pain scores at 6 h, 12 h, 24 h, 48 h, and 72 h postoperatively between the two groups. However, patients receiving posterior TAP had a significant reduction in narcotic intake ( p  = 0.0009).
Conclusion


Laparoscopic-assisted TAP block is a safe and effective option for regional analgesia in laparoscopic gynecologic surgery. Posterior TAP block may help to reduce narcotic usage postoperatively.",2020,"However, patients receiving posterior TAP had a significant reduction in narcotic intake ( p  = 0.0009).
","['Gynecology', '67 patients were analyzed in our study (n = 33 in posterior arm, n = 34 in lateral arm', 'laparoscopic gynecologic surgery', '82 patients allocated to either posterior (n = 38) or lateral (n = 44) TAP block groups']","['Laparoscopic Posterior Versus Lateral Transversus Abdominis Plane Block', 'Laparoscopic-assisted TAP block', 'Laparoscopic-assisted posterior or lateral TAP block', 'Transversus abdominis plane (TAP) block', 'liposomal bupivacaine mixture', 'posterior versus lateral approaches to laparoscopic-assisted TAP block']","['analgesic effects', 'narcotic intake', 'postoperative pain scores, opioid consumption, perioperative, and demographic characteristics', 'postoperative pain scores', 'Demographic characteristics including race, body mass index, comorbidities, American Society of Anesthesiologists classification, pre-operative diagnosis, complication rates, length of stay, and estimated blood loss', 'pain scores']","[{'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",67.0,0.404246,"However, patients receiving posterior TAP had a significant reduction in narcotic intake ( p  = 0.0009).
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Benabou', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Soorin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Christina H', 'Initials': 'CH', 'LastName': 'Tierney', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Messom', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Tassos C', 'Initials': 'TC', 'LastName': 'Kyriakides', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health.'}, {'ForeName': 'Shabnam M', 'Initials': 'SM', 'LastName': 'Kashani', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Dan-Arin', 'Initials': 'DA', 'LastName': 'Silasi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Azodi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}, {'ForeName': 'Farinaz', 'Initials': 'F', 'LastName': 'Seifi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yale University School of Medicine.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00032']
1929,32829105,Determination of the UGT1A1 polymorphism as guidance for irinotecan dose escalation in metastatic colorectal cancer treated with first-line bevacizumab and FOLFIRI (PURE FIST).,"AIM


Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism plays a crucial role in the increased susceptibility of patients to irinotecan and its toxicity. This study is a multicenter, randomised clinical trial comparing the clinical outcomes and adverse events (AEs) in metastatic colorectal cancer (mCRC) patients treated with bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan dose escalation as the first-line therapy.
METHODS


The control group received conventional biweekly FOLFIRI plus bevacizumab without UGT1A1 genotyping, whereas the study group received the same regimen with irinotecan dose escalation based on UGT1A1 genotyping. The primary end-point was progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate.
RESULTS


Over a median follow-up of 26.0 months (IQR, 17.0-35.0 months), study group (n = 107) was superior to the control group (n = 106) in PFS, OS, ORR, DCR, and metastasectomy rate (all P < 0.05). Furthermore, there were no significant differences in AEs ≥ grade III between the two groups, even with the 1.36-fold increase in the relative dose intensity of irinotecan in the study group. Dose escalation of irinotecan, an independent factor of ORR (P < 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
CONCLUSION


The current study revealed that mCRC patients, regardless of KRAS gene status, with UGT1A1 genotyping can tolerate escalated doses of irinotecan and potentially achieve a more favourable clinical outcome without significantly increased toxicities.
CLINICAL TRIAL REGISTRATION


NCT02256800.",2020,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","['metastatic colorectal cancer (mCRC) patients treated with', 'metastatic colorectal cancer treated with first-line']","['bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan', 'bevacizumab and FOLFIRI (PURE FIST', 'conventional biweekly FOLFIRI plus bevacizumab', 'irinotecan dose escalation based on UGT1A1 genotyping', 'irinotecan']","['DCR', 'progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate', 'PFS', 'PFS, OS, ORR, DCR, and metastasectomy rate', 'toxicities']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041986', 'cui_str': 'Uridine diphosphate'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0336667', 'cui_str': 'Fist'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0452964,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","[{'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: chunpin870132@yahoo.com.tw.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: baseball5824@yahoo.com.tw.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lin', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: linyiewen@yahoo.com.tw.'}, {'ForeName': 'Jui-Ho', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. Electronic address: rayhowang@gmail.com.'}, {'ForeName': 'Chang-Chieh', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Keelung Branch, Tri-Service General Hospital, Keelung, Taiwan. Electronic address: doc20276@gmail.com.'}, {'ForeName': 'Yung-Chuan', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Taipei Cathay General Hospital, Taipei, Taiwan. Electronic address: yungchuans@cgh.org.tw.'}, {'ForeName': 'Tzu-Liang', 'Initials': 'TL', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: golfma22@gmail.com.'}, {'ForeName': 'Hwei-Ming', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: phillipwhm@gmail.com.'}, {'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Tang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Sin-Lan Hospital, Tainan, Taiwan. Electronic address: schoetz.tang@gmail.com.'}, {'ForeName': 'Joe-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan. Electronic address: jbchen@vghtc.gov.tw.'}, {'ForeName': 'Tao-Wei', 'Initials': 'TW', 'LastName': 'Ke', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: ketaowei@gmail.com.'}, {'ForeName': 'Chang-Sung', 'Initials': 'CS', 'LastName': 'Tsai', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: chonsonechai@gmail.com.'}, {'ForeName': 'Hsuan-Yuan', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan. Electronic address: 107431@cch.org.tw.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: cy614112@ms14.hinet.net.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.031']
1930,32829109,High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production in obese men in response to an acute exercise bout.,"The aim of this study was to evaluate the inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin) profile of inactive obese men in response to two isoenergetic models of aerobic exercise training (~300  kcal each exercise session). Twenty-two participants (28.7 ± 1.6 years; BMI = 34.4 ± 0.1 kg/m 2 ) were randomized into two groups: I) HIIT: high-intensity interval training (10× 1 bout: 1 min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT). Both groups trained three times per week for 6-weeks. Fasting blood samples were collected before and 0, 30, and 60 min after exercise during the first and last training sessions for evaluation of: I) MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10 were analyzed before, 0, and 60 min after sessions. IL-6 concentration remained elevated up to 60-min after the acute exercise session (p < 0.001), and IL-10 concentration was higher after 30 and 60-min (p = 0.001) compared to rest, independent of training period and protocol. AUC of IL-10 presented effect of type of training (p = 0.023) with MICT group showed significantly higher values than the HIIT. The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period. Fifteen subjects presented decreased HOMA-IR after 6-weeks and seven presented an increase in this index. When we excluded the two least responsive subjects, it was possible to observe a decrease in HOMA-IR (p = 0.020) after training. Taken together, our results suggest that both HIIT and MICT (with same energy expenditure) promote similar effects on HOMA-IR and led to elevations in IL-10 production in LPS-stimulated whole blood, suggesting that leukocytes had an enhanced ability to secrete anti-inflammatory cytokines after the exercise bout.",2020,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","['Twenty-two participants (28.7\xa0±\xa01.6\xa0years; BMI\xa0=\xa034.4\xa0±\xa00.1\xa0kg/m 2 ', 'obese men in response to an acute exercise bout', 'inactive obese men']","['MICT', 'HIIT and MICT', 'IL-6', 'inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin', 'HIIT: high-intensity interval training (10× 1 bout: 1\xa0min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT', 'aerobic exercise training', 'High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production']","['MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10', 'HOMA-IR', 'Fasting blood samples', 'IL-10 secretion', 'concentration', 'IL-10 concentration']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0237388,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil; Physical Education, Physiotherapy, University Center of Maringa (UniCesumar), Parana, Brazil.'}, {'ForeName': 'Paula Alves', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Daniela Sayuri', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Batatinha', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Gilson Pires', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'José Cesar', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil. Electronic address: fabio.lira@unesp.br.'}]",Cytokine,['10.1016/j.cyto.2020.155249']
1931,32858301,The effects of an intimate partner violence educational intervention on nurses: A quasi-experimental study.,"Nurses play a unique role in responding to the needs of intimate partner violence survivors. However, nurses are not adequately prepared to manage intimate partner violence. This study assessed the effects of intimate partner violence educational interventions on nurses' knowledge, attitudes, and practice. A non-randomized controlled trial was conducted with a convenience sample of nurses (n = 104). Nurses in both the intervention and control groups completed pre- and post-test surveys using the self-reported Physician Readiness to Manage Intimate Partner Violence Survey. An intimate partner violence educational program based on World Health Organization guidelines was administered. The multilevel analysis controlling for pre-test results revealed a significant effect of the intervention on perceived intimate partner violence preparation (p = .000) and knowledge (p = .000), actual knowledge (p = .000), intimate partner violence opinions (attitudes and beliefs) related to preparation (p = .000), legal requirements (p = .00), workplace issues (p = .000), self-efficacy (p = .000), victim understanding (p = .000), victim autonomy (p = .000), and constraints (p = .000). However, the intervention did not affect self-reported practices (p = .583). Intimate partner violence educational programs must be integrated into nursing curricula and in-service training through a system approach.",2020,Nurses in both the intervention and control groups completed pre- and post-test surveys using the self-reported Physician Readiness to Manage Intimate Partner Violence Survey.,"['Intimate partner violence educational programs', 'convenience sample of nurses (n\xa0=\xa0104', 'nurses']","['intimate partner violence educational intervention', 'intimate partner violence educational interventions']","['legal requirements', 'intimate partner violence opinions (attitudes and beliefs', 'victim autonomy', 'perceived intimate partner violence preparation', 'actual knowledge', 'victim understanding', 'self-efficacy']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0137909,Nurses in both the intervention and control groups completed pre- and post-test surveys using the self-reported Physician Readiness to Manage Intimate Partner Violence Survey.,"[{'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Alhalal', 'Affiliation': 'Nursing College, King Saud University, Riyadh, Saudi Arabia. Electronic address: ealhalal@ksu.edu.sa.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102854']
1932,32858346,"Effects of treatment of sleep disorders on sleep, psychological and cognitive functioning and biomarkers in individuals with HIV/AIDS and under methadone maintenance therapy.","BACKGROUND


Poor sleep is a major complaint of people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing methadone maintenance therapy (MMT). We tested the impact of three different sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training + trazodone) on sleep, psychological functioning and biomarkers in males with HIV and undergoing MMT.
METHODS


A total of 75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention. Participants were randomly assigned to one of the following conditions: trazodone 50 mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT + TRAZ). At baseline, and six and 12 weeks later, participants completed questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety. In parallel, their cognitive performance (working memory; sustained attention) was assessed. Biomarkers (cortisol, BNDF, CD4 + ) were assessed at baseline and at the end of the study.
RESULTS


Over time, sleep disturbances decreased and daytime functioning and overall sleep quality improved. More specifically, both sleep disturbances and daytime functioning improved in the two SHT conditions from baseline to week 6. Daytime functioning remained stable from week 6 to week 12. Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12. Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing remained unchanged. Sustained attention performance improved over time from baseline to week 6 and remained high through to week 12. Biomarkers remained unchanged.
CONCLUSIONS


In males with HIV and undergoing MMT, treating sleep disturbances over a period of six to 12 weeks had a positive impact on aspects of sleep disturbance, symptoms of depression and anxiety, and cognitive performance. The results indicate that sleep hygiene training, either as stand-alone or in combination with trazodone, can produce positive results.",2020,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","['75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention', 'males with HIV and undergoing', 'males with HIV and undergoing MMT', 'people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing', 'individuals with HIV/AIDS and under methadone maintenance therapy']","['MMT', 'methadone maintenance therapy (MMT', 'sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training\xa0+\xa0trazodone', 'trazodone 50\xa0mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT\xa0+\xa0TRAZ', 'trazodone']","['sleep, psychological and cognitive functioning and biomarkers', 'sleep, psychological functioning and biomarkers', 'Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing', 'questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety', 'depression and anxiety', 'Sustained attention performance', 'sleep disturbances and daytime functioning', 'Daytime functioning', 'sleep disturbances', 'Biomarkers (cortisol, BNDF, CD4 + ', 'daytime functioning and overall sleep quality', 'sleep disturbance, symptoms of depression and anxiety, and cognitive performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",75.0,0.0231424,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Radmehr', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Mohamadi', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Omran', 'Initials': 'O', 'LastName': 'Davarinejad', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Dürsteler', 'Affiliation': 'University of Basel, Psychiatric Clinics, Division of Substance Use Disorders Basel, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: serge.brand@upk.ch.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.043']
1933,32865096,Effects of cranial electrotherapy stimulation on preoperative anxiety and blood pressure during anesthetic induction in patients with essential hypertension.,"OBJECTIVE


Cranial electrotherapy stimulation (CES) is a non-invasive treatment that improves symptoms such as anxiety and pain. The purpose of this study was to analyze the effect of CES pretreatment on levels of preoperative anxiety, pain, and hemodynamic responses-especially changes in blood pressure-during anesthetic induction in patients with essential hypertension.
METHODS


Eighty patients undergoing general anesthesia were randomly assigned to receive either no pretreatment (control group, n = 40) or CES pretreatment (CES group, n = 40). Anxiety scores, systolic and diastolic blood pressures, mean arterial pressure, and heart rate were measured in the general ward the evening before surgery, as well as in the preoperative holding area, operating room, and after intubation. Withdrawal responses to rocuronium injection were also measured.
RESULTS


Anxiety scores in the operating room were significantly lower in the CES group. Withdrawal responses to rocuronium injection were also significantly lower in the CES group. There were no significant differences in hemodynamic values between the two groups.
CONCLUSIONS


CES pretreatment reduces both preoperative anxiety levels and withdrawal responses to rocuronium injection. However, it does not have a significant effect on hemodynamic responses.",2020,"RESULTS


Anxiety scores in the operating room were significantly lower in the CES group.","['patients with essential hypertension', 'Eighty patients undergoing general anesthesia']","['CES', 'no pretreatment (control group, n\u2009=\u200940) or CES pretreatment (CES', 'cranial electrotherapy stimulation', 'Cranial electrotherapy stimulation (CES']","['Anxiety scores', 'hemodynamic responses', 'preoperative anxiety levels and withdrawal responses', 'Withdrawal responses', 'preoperative anxiety and blood pressure', 'hemodynamic values', 'levels of preoperative anxiety, pain, and hemodynamic responses', 'Anxiety scores, systolic and diastolic blood pressures, mean arterial pressure, and heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",80.0,0.0424184,"RESULTS


Anxiety scores in the operating room were significantly lower in the CES group.","[{'ForeName': 'Hee Won', 'Initials': 'HW', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Hyun Joong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Woon Young', 'Initials': 'WY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Won Kee', 'Initials': 'WK', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Too Jae', 'Initials': 'TJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Yoon Sook', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jae Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Gyeonggi-do, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060520939370']
1934,32865258,Effects of a mindfulness-based programme on the health- and work-related quality of life of healthcare professionals.,"BACKGROUND AND OBJECTIVES


The objective of mindfulness-based stress reduction (MBSR) programmes is to promote awareness of the present moment without judging, evaluating or reacting to the different thoughts or emotions that may arise. Development of these abilities appears especially important for healthcare professionals. The objective of this study was to evaluate the effectiveness and medium- and long-term effects of a MBSR programme for primary care (PC) health professionals on their health-related quality of life and quality of work life.
DESIGN


Randomised clinical trial using an intervention and control group with follow-up of the experimental group.
SETTING


Primary Care centres in the Alicante Public Health Service (Spain).
PARTICIPANTS


Participants were PC health professionals (N = 58) divided between an intervention group receiving the 8-week MBSR programme and a control group receiving a theoretical training session alone.
METHOD


Both groups were evaluated at baseline and at 8 weeks, and the intervention group was additionally evaluated at 3-, 6-, 9- and 12-month postprogramme.
RESULTS


In comparison to the control group, the intervention group obtained higher scores postintervention for mindfulness, health-related quality of life, mood and compassion satisfaction and a lower score for burnout. Improvements in mindfulness, mood and burnout syndrome persisted at 12 months after the programme.
CONCLUSIONS


In conclusion, MBSR is an effective intervention to enhance the health-related quality of life and quality of work life of Primary Care Health professionals.",2020,"In comparison to the control group, the intervention group obtained higher scores postintervention for mindfulness, health-related quality of life, mood and compassion satisfaction and a lower score for burnout.","['Participants were PC health professionals (N\xa0=\xa058) divided between an', 'Primary Care centres in the Alicante Public Health Service (Spain']","['MBSR', 'mindfulness-based programme', 'MBSR programme', 'intervention group receiving the 8-week MBSR programme and a control group receiving a theoretical training session alone', 'mindfulness-based stress reduction (MBSR) programmes']","['quality of life and quality of work life', 'mindfulness, mood and burnout syndrome', 'health- and work-related quality of life of healthcare professionals', 'scores postintervention for mindfulness, health-related quality of life, mood and compassion satisfaction']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0557391', 'cui_str': 'Quality of work'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1696945', 'cui_str': 'Burnout syndrome'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",58.0,0.045357,"In comparison to the control group, the intervention group obtained higher scores postintervention for mindfulness, health-related quality of life, mood and compassion satisfaction and a lower score for burnout.","[{'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Cascales-Pérez', 'Affiliation': 'Doctoral Programme in Health Sciences, Faculty of Health Sciences, University of Alicante, Alicante, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Ferrer-Cascales', 'Affiliation': 'Department of Health Psychology, University of Alicante, Alicante, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández-Alcántara', 'Affiliation': 'Department of Health Psychology, University of Alicante, Alicante, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Cabañero-Martínez', 'Affiliation': 'Department of Nursing, University of Alicante, Alicante, Spain.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12905']
1935,32861271,"A machine-learning algorithm for neonatal seizure recognition: a multicentre, randomised, controlled trial.","BACKGROUND


Despite the availability of continuous conventional electroencephalography (cEEG), accurate diagnosis of neonatal seizures is challenging in clinical practice. Algorithms for decision support in the recognition of neonatal seizures could improve detection. We aimed to assess the diagnostic accuracy of an automated seizure detection algorithm called Algorithm for Neonatal Seizure Recognition (ANSeR).
METHODS


This multicentre, randomised, two-arm, parallel, controlled trial was done in eight neonatal centres across Ireland, the Netherlands, Sweden, and the UK. Neonates with a corrected gestational age between 36 and 44 weeks with, or at significant risk of, seizures requiring EEG monitoring, received cEEG plus ANSeR linked to the EEG monitor displaying a seizure probability trend in real time (algorithm group) or cEEG monitoring alone (non-algorithm group). The primary outcome was diagnostic accuracy (sensitivity, specificity, and false detection rate) of health-care professionals to identify neonates with electrographic seizures and seizure hours with and without the support of the ANSeR algorithm. Neonates with data on the outcome of interest were included in the analysis. This study is registered with ClinicalTrials.gov, NCT02431780.
FINDINGS


Between Feb 13, 2015, and Feb 7, 2017, 132 neonates were randomly assigned to the algorithm group and 132 to the non-algorithm group. Six neonates were excluded (four from the algorithm group and two from the non-algorithm group). Electrographic seizures were present in 32 (25·0%) of 128 neonates in the algorithm group and 38 (29·2%) of 130 neonates in the non-algorithm group. For recognition of neonates with electrographic seizures, sensitivity was 81·3% (95% CI 66·7-93·3) in the algorithm group and 89·5% (78·4-97·5) in the non-algorithm group; specificity was 84·4% (95% CI 76·9-91·0) in the algorithm group and 89·1% (82·5-94·7) in the non-algorithm group; and the false detection rate was 36·6% (95% CI 22·7-52·1) in the algorithm group and 22·7% (11·6-35·9) in the non-algorithm group. We identified 659 h in which seizures occurred (seizure hours): 268 h in the algorithm versus 391 h in the non-algorithm group. The percentage of seizure hours correctly identified was higher in the algorithm group than in the non-algorithm group (177 [66·0%; 95% CI 53·8-77·3] of 268 h vs 177 [45·3%; 34·5-58·3] of 391 h; difference 20·8% [3·6-37·1]). No significant differences were seen in the percentage of neonates with seizures given at least one inappropriate antiseizure medication (37·5% [95% CI 25·0 to 56·3] vs 31·6% [21·1 to 47·4]; difference 5·9% [-14·0 to 26·3]).
INTERPRETATION


ANSeR, a machine-learning algorithm, is safe and able to accurately detect neonatal seizures. Although the algorithm did not enhance identification of individual neonates with seizures beyond conventional EEG, recognition of seizure hours was improved with use of ANSeR. The benefit might be greater in less experienced centres, but further study is required.
FUNDING


Wellcome Trust, Science Foundation Ireland, and Nihon Kohden.",2020,"Although the algorithm did not enhance identification of individual neonates with seizures beyond conventional EEG, recognition of seizure hours was improved with use of ANSeR. The benefit might be greater in less experienced centres, but further study is required.
","['Neonates with a corrected gestational age between 36 and 44 weeks with, or at significant risk of, seizures requiring EEG monitoring, received cEEG plus ANSeR linked to the EEG monitor displaying a seizure probability trend in real time (algorithm group) or', '132 neonates', 'neonatal seizure recognition', 'eight neonatal centres across Ireland, the Netherlands, Sweden, and the UK']","['machine-learning algorithm', 'continuous conventional electroencephalography (cEEG', 'cEEG monitoring alone', 'automated seizure detection algorithm called Algorithm']","['percentage of seizure hours correctly identified', 'false detection rate', 'diagnostic accuracy (sensitivity, specificity, and false detection rate) of health-care professionals to identify neonates with electrographic seizures and seizure hours with and without the support of the ANSeR algorithm', 'Electrographic seizures', 'percentage of neonates with seizures given at least one inappropriate antiseizure medication']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1304879', 'cui_str': 'Electroencephalographic monitoring regime'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",132.0,0.175097,"Although the algorithm did not enhance identification of individual neonates with seizures beyond conventional EEG, recognition of seizure hours was improved with use of ANSeR. The benefit might be greater in less experienced centres, but further study is required.
","[{'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Pavel', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Rennie', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'de Vries', 'Affiliation': 'Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Blennow', 'Affiliation': 'Department of Neonatal Medicine, Karolinska University Hospital, Stockholm, Sweden; Division of Paediatrics, Department CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Foran', 'Affiliation': 'Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Divyen K', 'Initials': 'DK', 'LastName': 'Shah', 'Affiliation': 'Royal London Hospital, London, UK; London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ronit M', 'Initials': 'RM', 'LastName': 'Pressler', 'Affiliation': 'Department of Clinical Neurophysiology, Great Ormond Street Hospital for Children NHS Trust, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kapellou', 'Affiliation': 'Homerton University Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Eugene M', 'Initials': 'EM', 'LastName': 'Dempsey', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Mathieson', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pavlidis', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'van Huffelen', 'Affiliation': 'Clinical Neurophysiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Livingstone', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Mona C', 'Initials': 'MC', 'LastName': 'Toet', 'Affiliation': 'Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Weeke', 'Affiliation': 'Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Finder', 'Affiliation': 'Department of Neonatal Medicine, Karolinska University Hospital, Stockholm, Sweden; Division of Paediatrics, Department CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Subhabrata', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Deirdre M', 'Initials': 'DM', 'LastName': 'Murray', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Marnane', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland.'}, {'ForeName': 'Geraldine B', 'Initials': 'GB', 'LastName': 'Boylan', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland. Electronic address: g.boylan@ucc.ie.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30239-X']
1936,32861897,Testing an app-based intervention to improve insomnia in patients with epilepsy: A randomized controlled trial.,"PURPOSE


Insomnia has adverse effects on people with epilepsy. We aimed to test a novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention on insomnia symptoms and social psychological factors in people with epilepsy and to examine the possible mechanisms among the factors.
METHODS


Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia. A two-arm randomized controlled trial design was used, consisting of a treatment group (CBT-I; n = 160) and control group (patient education; n = 160). Primary outcomes were self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy. Secondary outcomes were attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL). All outcomes were measured at baseline, and at one, three, and six months postintervention, except objective sleep, which was assessed at baseline, and one and six months postintervention. Data were analyzed using linear mixed models.
RESULTS


Current findings showed that sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency were significantly improved in the CBT-I group compared with the patient education group at all measurement points. Also, the CBT-I group had significantly improved anxiety, depression, and QoL compared with the patient education group. Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
CONCLUSION


Results support the use of the CBT-I app to improve sleep outcomes among people with epilepsy.",2020,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
","['patients with epilepsy', 'people with epilepsy', 'Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia']","['Testing an app-based intervention', 'novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention']","['insomnia symptoms and social psychological factors', 'sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency', 'attitude, intention, coping planning, self-monitoring, and behavioral automaticity', 'anxiety, depression, and QoL', 'self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy', 'attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL', 'sleep outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0878237,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
","[{'ForeName': 'Daniel Kwasi', 'Initials': 'DK', 'LastName': 'Ahorsu', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Imani', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Nygårdh', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Broström', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Department of Clinical Neurophysiology, University Hospital, Linköping, Sweden.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: Pakpour_Amir@yahoo.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107371']
1937,32862425,Effect of supervised group exercise on psychological well-being among pregnant women with or at high risk of depression (the EWE Study): A randomized controlled trial.,"INTRODUCTION


Depression is expected to be the leading cause of disability worldwide by 2030. The prevalence is increasing and is two-fold higher in women than in men, women being at particularly high risk during hormonal transition phases such as pregnancy and the postpartum period. The objective for this trial was to assess the effect of supervised group exercise on psychological well-being and symptoms of depression among pregnant women with or at high risk of depression.
MATERIAL AND METHODS


This study was undertaken at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark, from August 2016 to September 2018. Pregnant women with a current or previous history of depression and/or anxiety requiring treatment within the last 10 years, or use of antidepressants 3 months before or during pregnancy, were randomly assigned to 12 weeks of supervised group exercise from 17 to 22 weeks of gestation twice weekly, or to a control group. The primary outcome was self-reported psychological well-being at 29-34 weeks of gestation, measured by the five-item World Health Organization Well-being Index (WHO-5). Secondary outcomes included delivery outcomes and psychological well-being (WHO-5) 8 weeks postpartum.
RESULTS


The intention-to-treat analysis showed no significant effect on psychological well-being on the primary outcome. Mean WHO-5 score in the intervention group was 2.0 (95% CI -1.3 to 5.2, P = .2) higher than in the control group. Per protocol analysis of women who attended ≥75% of the exercise sessions showed a statistically significant higher mean WHO-5 score relative to the control group at gestational weeks 29-34. Eight weeks postpartum the intervention group reported higher psychological well-being than the control group, mean difference in WHO-5 score of 5.5 (95% CI 1.0-10.1, P = .04).
CONCLUSIONS


Supervised group exercise did not improve psychological well-being for women with or at high risk of depression at 29-34 weeks of gestation. Eight weeks postpartum the intervention group reported significantly higher psychological well-being than the control group. Based on our results, supervised exercise in groups is a safe complementary course of treatment alongside the existing antenatal care.",2020,"the intervention group reported higher psychological well-being than the control group, mean difference in WHO-5 of 5.5 (95% CI: 1.0 to 10.1, P=0.04).
","['pregnant women with or at high risk of depression (the EWE Study', 'pregnant women with or at high risk of depression', 'Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark, from August 2016-September 2018', 'Pregnant women with a current or previous history of depression or/and anxiety requiring treatment within the last ten years, or use of antidepressants three months prior to or during pregnancy']","['supervised group exercise', 'supervised exercise']","['psychological well-being and symptoms of depression', 'WHO-5 score', 'Mean', 'delivery outcomes and psychological well-being (WHO-5) eight weeks postpartum', 'self-reported psychological well-being at 29-34 weeks of gestation, measured by the five-item World Health Organization Well-being Index (WHO-5']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0337831', 'cui_str': 'Ewe'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.119922,"the intervention group reported higher psychological well-being than the control group, mean difference in WHO-5 of 5.5 (95% CI: 1.0 to 10.1, P=0.04).
","[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Broberg', 'Affiliation': 'Department of Obstetrics, Copenhagen University Hospital Rigshospitalet, Copenhangen, Denmark.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tabor', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rosthøj', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Backhausen', 'Affiliation': 'Department of Gynecology and Obstetrics, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Vibe G', 'Initials': 'VG', 'LastName': 'Frokjaer', 'Affiliation': 'Neurobiology Research Unit, Department of Neurology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Damm', 'Affiliation': 'Department of Obstetrics, Copenhagen University Hospital Rigshospitalet, Copenhangen, Denmark.'}, {'ForeName': 'Hanne K', 'Initials': 'HK', 'LastName': 'Hegaard', 'Affiliation': 'Department of Obstetrics, Copenhagen University Hospital Rigshospitalet, Copenhangen, Denmark.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13982']
1938,32862694,Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization.,"BACKGROUND


Longitudinal bleeding risk scores have been validated in patients treated with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention. How these scores apply to the population of patients with acute coronary syndrome (ACS) treated without revascularization remains unknown. The objective was to evaluate and compare the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) bleeding risk scores in the medically managed patients with ACS treated with DAPT.
METHODS AND RESULTS


TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a double-blind, placebo-controlled randomized trial conducted from 2008 to 2012 over a median follow-up of 17.0 months in 966 sites (52 countries). High-risk patients with unstable angina or non-ST-segment-elevation myocardial infarction who did not undergo revascularization were randomized to prasugrel or clopidogrel. The PRECISE-DAPT, PARIS, and DAPT (bleeding component) risk scores were applied in the TRILOGY ACS population to evaluate their performance to predict adjudicated non-coronary artery bypass grafting-related GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe/life-threatening/moderate and TIMI (Thrombolysis in Myocardial Infarction) major/minor bleeding with time-dependent c-indices. Among the 9326 participants, median age was 66 years (interquartile range, 59-74 years), and 3650 were females (39.1%). A total of 158 (1.69%) GUSTO severe/life-threatening/moderate and 174 (1.87%) TIMI major/minor non-coronary artery bypass grafting bleeding events occurred. The c-indices (95% CI) of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores through 12 months were 0.716 (0.677-0.758), 0.693 (0.658-0.733), and 0.674 (0.637-0.713), respectively, for GUSTO bleeding and 0.624 (0.582-0.666), 0.612 (0.578-0.651), and 0.608 (0.571-0.649), respectively, for TIMI bleeding. There was no significant difference in the c-indices of each score based upon pairwise comparisons.
CONCLUSIONS


Among medically managed patients with ACS treated with DAPT, the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores were reasonable and similar to their performances in the derivation percutaneous coronary intervention populations. Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00699998.",2020,Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making.,"['9326 participants, median age was 66 years (interquartile range, 59-74 years), and 3650 were females (39.1', 'patients treated with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention', 'Thrombolysis in Myocardial Infarction', '2008 to 2012 over a median follow-up of 17.0 months in 966 sites (52 countries', 'medically managed patients with ACS treated with DAPT', 'High-risk patients with unstable angina or non-ST-segment-elevation myocardial infarction who did not undergo revascularization', 'patients with acute coronary syndrome (ACS', 'patients with ACS treated with', 'medically managed patients with ACS treated with']","['Open Occluded Coronary Arteries', 'prasugrel or clopidogrel', 'coronary artery bypass grafting-related GUSTO', 'DAPT', 'placebo', 'Dual Antiplatelet Therapy']","['TIMI bleeding', 'TIMI major/minor non-coronary artery bypass grafting bleeding events', 'Bleeding risk scores', 'severe/life-threatening/moderate and TIMI']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",9326.0,0.0299741,Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Marquis-Gravel', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Neely', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital, Switzerland (M.V., F.C.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital, Switzerland (M.V., F.C.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Van Klaveren', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, the Netherlands (D.V.K.).'}, {'ForeName': 'Rituparna', 'Initials': 'R', 'LastName': 'Altner', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre and Division of Cardiology, University of Alberta, Edmonton, Canada (P.W.A.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (K.A.A.F.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand (H.D.W.).'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006582']
1939,32827598,Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: a randomized controlled trial: Effectiveness of a parental-oriented mobile text messages to early childhood caries control.,"OBJECTIVES


To evaluate the effectiveness of educational messages as an aid in the control of early childhood caries (ECC) in low socioeconomic children.
METHODS


A single-blinded, randomized, and parallel-group study was conducted with 104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded). The participants were randomly allocated into control and intervention groups (1:1), stratified by eHealth literacy scores (eHEALS) of parents and caries experience of children. Each 2 weeks, text messages were sent to parents of intervention group via WhatsApp. Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS) were assessed at baseline, 3- and 6-month follow-up, while eHEALS and dietary habits were determined at baseline and 6-month follow-up. Statistical analysis was performed to intra and intergroup comparisons through Fischer´s exact and McNemar tests, and Mann-Whitney U and Friedman tests, respectively (P < 0.05).
RESULTS


Despite similarities between groups, intervention increased parental eHEALS scores, influenced the reports about the children's consumption of sugar-free sweets and controlled the severity of ECC.
CONCLUSION


Therefore, mobile text messages were effective to control the severity of ECC in low socioeconomic preschoolers, improving parental eHealth literacy and changing children's dietary patterns.
CLINICAL SIGNIFICANCE


These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.",2020,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"['low socioeconomic children', '104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded']","['educational messages', 'parental-oriented mobile text messages', 'Parental-oriented educational mobile messages']","['Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS', 'parental eHEALS scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0747732,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lotto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Strieder', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Patricia Estefania', 'Initials': 'PE', 'LastName': 'Ayala Aguirre', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thais Marchini', 'Initials': 'TM', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'de Andrade Moreira Machado', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil. Electronic address: thiagocruvinel@fob.usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103456']
1940,32831109,"Effects of Bang® Keto Coffee Energy Drink on Metabolism and Exercise Performance in Resistance-Trained Adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.","BACKGROUND


Energy drinks are often consumed by the general population, as well as by active individuals seeking to enhance exercise performance and augment training adaptations. However, limited information is available regarding the efficacy of these products. Thus, the purpose of this study was to determine the effects of a commercially available caffeine- and protein-containing energy drink on metabolism and muscular performance.
METHODS


Sixteen resistance-trained males (n = 8; mean ± SD; age: 22.4 ± 4.9 years; body mass: 78.8 ± 14.0 kg; body fat: 15.3 ± 6.4%) and females (n = 8; age: 24.5 ± 4.8 years; body mass: 67.5 ± 11.9 kg; body fat: 26.6 ± 7.1%) participated in this randomized, double-blind, placebo-controlled, crossover study. Following a familiarization visit, participants completed two identical visits to the laboratory separated by 5-10 days, each of which consisted of indirect calorimetry energy expenditure (EE) assessments before and after consumption of the beverage (Bang® Keto Coffee; 130 kcal, 300 mg caffeine, 20 g protein) or placebo (30 kcal, 11 mg caffeine, 1 g protein) as well as after exercise testing. In addition, participants' subjective feelings of energy, fatigue, and focus as well as muscular performance (leg press one-repetition maximum and repetitions to fatigue, maximal isometric and isokinetic squat testing) were assessed. Multiple repeated measures ANOVAs with Tukey post-hoc tests were used to analyze data. Estimates of effect size were quantified via partial eta squared (η P 2 ) and Hedge's g.
RESULTS


A significant interaction effect was identified for EE (p < 0.001, η P 2  = 0.52) but not respiratory exchange ratio (p = 0.17, η P 2  = 0.11). Following consumption of the beverage, EE was 0.77 kcal·min - 1  greater than placebo at the post-beverage time point (p < 0.001) and 0.37 kcal·min - 1  greater than placebo at the post-exercise time point (p = 0.011). However, no between-condition differences were detected for any subjective or muscular performance outcomes.
CONCLUSIONS


The results of this study suggest that consumption of the energy drink had minimal effects on lower-body muscular performance and subjective factors in the context of a laboratory setting. However, the beverage was found to significantly increase energy expenditure compared to placebo immediately following ingestion as well as during the recovery period after an exercise bout, suggesting that active individuals may improve acute metabolic outcomes via consumption of a caffeine- and protein-containing energy drink.
TRIAL REGISTRATION


This trial was prospectively registered at ClinicalTrials.gov (Identifier: NCT04180787 ; Registered 29 November 2019).",2020,"A significant interaction effect was identified for EE (p < 0.001, η P 2  = 0.52) but not respiratory exchange ratio (p = 0.17, η P 2  = 0.11).","['Resistance-Trained Adults', 'mean\u2009±\u2009SD; age: 22.4\u2009±\u20094.9\u2009years; body mass: 78.8\u2009±\u200914.0\u2009kg; body fat: 15.3\u2009±\u20096.4%) and females (n\xa0=\u20098; age: 24.5\u2009±\u20094.8\u2009years; body mass: 67.5\u2009±\u200911.9\u2009kg; body fat: 26.6\u2009±\u20097.1', 'Sixteen resistance-trained males (n\xa0']","['caffeine- and protein-containing energy drink', 'caffeine, 20\u2009g protein) or placebo', 'placebo', 'Placebo', 'Bang® Keto Coffee Energy Drink']","['subjective or muscular performance outcomes', 'lower-body muscular performance and subjective factors', 'Metabolism and Exercise Performance', 'subjective feelings of energy, fatigue, and focus as well as muscular performance (leg press one-repetition maximum and repetitions to fatigue, maximal isometric and isokinetic squat testing', 'energy expenditure']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",,0.48176,"A significant interaction effect was identified for EE (p < 0.001, η P 2  = 0.52) but not respiratory exchange ratio (p = 0.17, η P 2  = 0.11).","[{'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Harty', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Stratton', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Escalante', 'Affiliation': 'California State University, San Bernardino, California, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Dellinger', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Abegale D', 'Initials': 'AD', 'LastName': 'Williams', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'White', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Smith', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Baylor A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Sanders', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA. grant.tinsley@ttu.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00374-5']
1941,32839957,Examining the Role of Lateral Parietal Cortex in Emotional Distancing Using TMS.,"We recently proposed a neurocognitive model of distancing-an emotion regulation tactic-with a focus on the lateral parietal cortex. Although this brain area has been implicated in both cognitive control and self-projection processes during distancing, fMRI work suggests that these processes may be dissociable here. This preregistered (NCT03698591) study tested the contribution of left temporoparietal junction (TPJ) to distancing using repetitive transcranial magnetic stimulation. We hypothesized that inhibiting left TPJ would decrease the efficiency of distancing but not distraction, another regulation tactic with similar cognitive control requirements, thus implicating this region in the self-projection processes unique to distancing. Active and sham continuous theta burst stimulation (cTBS) were applied to 30 healthy adults in a single-session crossover design. Tactic efficiency was measured using online reports of valence and effort. The stimulation target was established from the group TPJ fMRI activation peak in an independent sample using the same distancing task, and anatomical MRI scans were used for individual targeting. Analyses employed both repeated-measures ANOVA and analytic procedures tailored to crossover designs. Irrespective of cTBS, distancing led to greater decreases in negative valence over time relative to distraction, and distancing effort decreased over time while distraction effort remained stable. Exploratory analyses also revealed that active cTBS made distancing more effortful, but not distraction. Thus, left TPJ seems to support self-projection processes in distancing, and these processes may be facilitated by repeated use. These findings help to clarify the role of lateral parietal cortex in distancing and inform applications of distancing and distraction.",2020,"Irrespective of cTBS, distancing led to greater decreases in negative valence over time relative to distraction, and distancing effort decreased over time while distraction effort remained stable.",['30 healthy adults'],"['left temporoparietal junction (TPJ) to distancing using repetitive transcranial magnetic stimulation', 'Active and sham continuous theta burst stimulation (cTBS']","['Tactic efficiency', 'negative valence']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",30.0,0.0111624,"Irrespective of cTBS, distancing led to greater decreases in negative valence over time relative to distraction, and distancing effort decreased over time while distraction effort remained stable.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Powers', 'Affiliation': 'Department of Psychology & Neuroscience, Duke University, Center for Cognitive Neuroscience, Box 90999, Durham, NC, 27708-0999, USA.'}, {'ForeName': 'Simon W', 'Initials': 'SW', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrada D', 'Initials': 'AD', 'LastName': 'Neacsiu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'LaBar', 'Affiliation': 'Department of Psychology & Neuroscience, Duke University, Center for Cognitive Neuroscience, Box 90999, Durham, NC, 27708-0999, USA. klabar@duke.edu.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00821-5']
1942,32833578,Efficacy of Scaling and Root Planing with Photobiomodulation for Treating Periodontitis in Gutka Chewers: A Randomized Controlled Trial.,"Objective:  To explore the influence of photobiomodulation (PBMT) as an adjuvant to scaling and root planing (SRP) for treating periodontitis among  gutka  chewers.  Materials and methods:  Self-reported smokeless-tobacco ( gutka ) users were enrolled; and underwent SRP with (test group) and without (control group) PBMT. Full-mouth plaque index (P-I), bleeding upon probing (BUP), probing depth (P-D) clinical attachment loss (CAL), marginal bone loss (MBL) (on mesial and distal surfaces of the teeth), and number of missing teeth were recorded before treatment and at 3 and 6 months. Group comparisons were performed and  p  < 0.05 was referred significant.  Results:  In the control group, P-I ( p  < 0.013), BUP ( p  < 0.001), and P-D ( p  < 0.012) were high at baseline compared with 3 months follow-up. P-I, BUP, and P-D were higher in the test group, at baseline in comparison with the 3-month ( p  < 0.001) and 6-month ( p  < 0.01) follow-up. At 3 and 6 months, scores of P-I, BUP, and P-D were high in the control compared with the test group. No difference in CAL, and mesial and distal MBL was found among patients of both groups at 3 and 6 months.  Conclusions:  Among  gutka  chewers, SRP with PBMT is more efficient than SRP alone in the management of periodontitis.",2020,"No difference in CAL, and mesial and distal MBL was found among patients of both groups at 3 and 6 months.  ","['Treating Periodontitis in Gutka Chewers', 'Self-reported smokeless-tobacco ( gutka ) users were enrolled; and underwent']","['Scaling and Root Planing with Photobiomodulation', 'photobiomodulation (PBMT', 'scaling and root planing (SRP', 'SRP', 'SRP with (test group) and without (control group) PBMT']","['BUP', 'Full-mouth plaque index (P-I), bleeding upon probing (BUP), probing depth (P-D) clinical attachment loss (CAL), marginal bone loss (MBL) (on mesial and distal surfaces of the teeth), and number of missing teeth', 'P-I, BUP, and P-D', 'CAL, and mesial and distal MBL', 'scores of P-I, BUP, and P-D']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4289021', 'cui_str': 'Gutka Tobacco'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040338', 'cui_str': 'Smokeless Tobacco'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.054574,"No difference in CAL, and mesial and distal MBL was found among patients of both groups at 3 and 6 months.  ","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Rabiah', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nawwaf', 'Initials': 'N', 'LastName': 'Al-Hamoudi', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Khulud Abdulrahman', 'Initials': 'KA', 'LastName': 'Al-Aali', 'Affiliation': 'Department of Clinical Dental Sciences, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Lonnie', 'Initials': 'L', 'LastName': 'Slapar', 'Affiliation': 'Department of General Dentistry, Eastman Institute for Oral Health, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'AlHelal', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Modhi', 'Initials': 'M', 'LastName': 'Al Deeb', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Mokeem', 'Affiliation': 'Department of Periodontics and Community Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Abduljabbar', 'Affiliation': 'Department of Prosthetic Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4819']
1943,32833606,Correction to: Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial.,,2020,,['After Aneurysmal Subarachnoid Hemorrhage'],['Goal-Directed Therapy'],['Delayed Ischemia'],"[{'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}]","[{'cui': 'C0022116', 'cui_str': 'Ischemia'}]",,0.271616,,[],Stroke,['10.1161/STR.0000000000000348']
1944,32835607,Effect of dispersed form on the bioavailability of β-carotene from daily intake in humans.,"In a randomized double-blind crossover study, a canned beverage was prepared using an emulsion dispersion formulation (EM) of β-carotene and a crystal dispersion formulation (CR) of β-carotene; the beverages were ingested by human subjects daily for 2 weeks to compare the β-carotene bioavailability. EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement. Bioaccessibility is the ratio of the solubilized fraction to the whole amount ingested. Bioaccessibility of β-carotene from EM-β-carotene was higher than that from CR-β-carotene in an  in vitro  digestion test. Contrarily, β-carotene from CR-β-carotene, consists of all- trans -β-carotene, was higher than that from EM-β-carotene, consists of a mixture of  cis  and all- trans -β-carotene, on the uptake by intestinal Caco-2 cells, suggesting that bioaccessibility was a critical factor in β-carotene bioavailability in this study. EM-β-carotene thus has potential as a food coloring agent with value added because it enhances β-carotene bioavailability.",2020,"EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement.",['humans'],"['EM-β-carotene', 'emulsion dispersion formulation (EM) of β-carotene and a crystal dispersion formulation (CR) of β-carotene']",['β-carotene bioavailability'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0342202,"EM-β-carotene enhanced the β-carotene concentrations in human plasma approximately 4-fold, but CR-β-carotene showed no statistically significant enhancement.","[{'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Kotake-Nara', 'Affiliation': 'Food Research Institute, National Agriculture and Food Research Organization , Tsukuba, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Hase', 'Affiliation': 'Food Research Institute, National Agriculture and Food Research Organization , Tsukuba, Japan.'}]","Bioscience, biotechnology, and biochemistry",['10.1080/09168451.2020.1803728']
1945,32836103,Self-reported health status and the associated risk of mortality in heart failure: The DANISH trial.,"OBJECTIVE


To examine the gradual association between self-reported health status and mortality in patients with heart failure (HF) as current research has focused on poor health status and increased risk of mortality.
METHOD


This is a substudy of the DANISH (Defibrillator Implantation in Patients with Nonischemic Systolic HF) trial in which 1116 patients were randomized to receive or not receive an implantable cardioverter-defibrillator. Health status was assessed by a single question of the Short-Form 36. Patients were classified as having excellent/very good, good, fair (reference) or poor health status. We assessed the association between health status and mortality using multivariable Cox proportional hazard models.
RESULTS


Self-reported health status was completed by 943 (84%) patients at randomization with a median follow-up of 67 months and a health status distribution of; excellent/very good (n = 79, 8%), good (n = 369, 39%), fair (n = 409, 43%), and poor (n = 86, 9%). All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57). The gradual difference yielded a crude hazard ratio (HR) of 0.40, 95% CI 0.20-0.80 (adjusted HR 0.47 (95% CI 0.23-0.95) for excellent/ very good health status, HR 0.71, 95% CI 0.52-0.97 (adjusted HR 0.78 (95% CI 0.56-1.08) for good health status. Poor being worse than fair health status yielded a crude HR of 1.07, 95% CI 0.67-1.69.
CONCLUSION


Excellent/very good self-reported health status as assessed by a single question was associated with lower long-term mortality in patients with HF.",2020,"All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57).","['patients with heart failure (HF', 'patients with HF', 'heart failure', 'Patients with Nonischemic Systolic HF) trial in which 1116 patients', 'Patients were classified as having excellent/very good, good, fair (reference) or poor health status']","['implantable cardioverter-defibrillator', 'DANISH (Defibrillator Implantation']","['Self-reported health status', 'Health status', 'crude hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1116.0,0.0161855,"All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57).","[{'ForeName': 'Johan S', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: johan.skov.bundgaard.01@regionh.dk.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology and Clinical Research, Nordsjaellands Hospital, Hillerød, Denmark; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Rørth', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Melchior', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.; Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik M', 'Initials': 'UM', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110220']
1946,32836109,Sleep problems associated with long-term mortality in acute coronary syndrome: Effects of depression comorbidity and treatment.,"OBJECTIVES


The effects of sleep disturbance and its treatment on the prognosis of patients with acute coronary syndrome (ACS) are not well understood. This study investigated the impact of sleep disturbance on long-term all-cause mortality, according to depression comorbidity and treatment, in patients with ACS.
METHODS


A cross-sectional baseline study and a nested 24-week double-blind escitalopram-placebo controlled trial were carried out from May 2007 to March 2013; 5-12-year follow-up for all-cause mortality was conducted. A total of 1152 patients with ACS were stratified by baseline depression comorbidity and treatment allocation into four groups: no depression (N = 706), depression on escitalopram (N = 149), depression on placebo (N = 151), and depression on medical care as usual (CAU; N = 146). Sleep disturbance was evaluated by the Leeds Sleep Evaluation Questionnaire. During the 5-12-year follow-up, Kaplan-Meyer event rates for all-cause mortality were calculated; hazard ratios (HRs) using Cox regression models were estimated after adjustment for a range of covariates.
RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59). The associations between worse sleep states and long-term all-cause mortality were significant in patients without depression and in patients with depression who received CAU, but not in patients with depression who participated in the 24-week trial.
CONCLUSIONS


Routine evaluations of sleep disturbance in ACS and further treatment allocation may contribute to reducing long-term mortality associated with the disease.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier for the 24 week drug trial, NCT00419471.",2020,"RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59).","['May 2007 to March 2013; 5-12-year follow-up for all-cause mortality was conducted', 'acute coronary syndrome', '1152 patients with ACS were stratified by baseline depression comorbidity and treatment allocation into four groups: no depression (N\xa0=\xa0706), depression on escitalopram (N\xa0=\xa0149), depression on placebo (N\xa0=\xa0151), and depression on medical care as usual (CAU; N\xa0=\xa0146', 'patients with acute coronary syndrome (ACS', 'patients with ACS']","['CAU', 'escitalopram-placebo']","['Sleep disturbance', 'Leeds Sleep Evaluation Questionnaire']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1152.0,0.0763454,"RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59).","[{'ForeName': 'Ju-Wan', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK; South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'Hee-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Hee-Ju', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Sung-Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Il-Seon', 'Initials': 'IS', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Min-Chul', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Keun', 'Initials': 'YK', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Myung-Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jin-Sang', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea. Electronic address: jmkim@chonnam.ac.kr.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.08.004']
1947,32836188,Comparison of low and high inspiratory oxygen fraction added to lung-protective ventilation on postoperative pulmonary complications after abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative lung-protective ventilation strategy has been recommended to reduce postoperative pulmonary complications (PPCs). However, the role of inspiratory oxygen fraction (FiO 2 ) in this protection remains highly uncertain. We aimed to evaluate the effect of intraoperative low (30%) versus high (80%) FiO 2  in the context of lung-protective ventilation strategy on PPCs in patients undergoing abdominal surgery.
DESIGN


Prospective, two-arm, randomized controlled trial.
SETTING


Tertiary university hospital in China.
PATIENTS


A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study.
INTERVENTION


Patients were randomly assigned to receive either 30% or 80% FiO 2  during the intraoperative period. All patients received volume-controlled mechanical ventilation with lung-protective ventilation approach, which included a tidal volume of 8 ml kg -1  of predicted body weight, a positive end-expiratory pressure level of 6-8 cmH 2 O, and repeated recruitment maneuvers.
MEASUREMENTS


The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis. The severity grade of PPCs was measured as a key secondary outcome.
MAIN RESULTS


Two hundred and fifty-one patients completed the trial. PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025). The severity of PPCs within the first 7 days following surgery was attenuated significantly in the low (30%) FiO 2  group (p = 0.001).
CONCLUSIONS


Among patients undergoing abdominal surgery under general anesthesia, an intraoperative lung-protective ventilation strategy with 30% FiO 2  compared with 80% FiO 2  did not reduce the incidence of PPCs. And the use of 30% FiO 2  resulted in less severe pulmonary complications.",2020,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","['patients undergoing abdominal surgery', 'patients undergoing abdominal surgery under general anesthesia', 'Tertiary university hospital in China', 'Two hundred and fifty-one patients completed the trial', 'A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study', 'postoperative pulmonary complications after abdominal surgery']","['volume-controlled mechanical ventilation with lung-protective ventilation approach', 'low and high inspiratory oxygen fraction added to lung-protective ventilation']","['severe pulmonary complications', 'composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis', 'PPCs', 'severity of PPCs', 'severity grade of PPCs', 'incidence of PPCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.482006,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Yu-Lian', 'Initials': 'YL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Meng-Qiu', 'Initials': 'MQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China. Electronic address: yuhaishan117@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110009']
1948,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
1949,32842178,[The efficacy of OM85-BV in the treatment of recurrent upper respiratory tract infection with adenoid hypertrophy and the preliminary exploration of potential therapeutic mechanism].,"Objective: To observe the efficacy of OM85-BV in the treatment of recurrent upper respiratory tract infection with adenoid hypertrophy and to explore its possible mechanism.  Method: Four hundred and forty-eight children with recurrent upper respiratory tract infection and adenoid hypertrophy were collected. Three hundred and twenty-six patients in the control group were treated with conventional drugs, and one hundred and twenty-two patients in the observation group were treated with OM85-BV+conventional drugs, and the treatment lasted 12 weeks. The sleep obstructive symptoms of adenoid hypertrophy were scored according to OSA-18 before and after the treatment respectively（0, 6, 12 weeks）. The symptoms scores and effective rate of treatment between the study and the control group were compared. The patients in the control group and the observation group who were unresponsive to drug treatment received surgery after 12 weeks of drug treatment. The levels of serum IL-2, IL-4, IL-6, IL-10, TNF, IFN-γ and IgE, the ratio of serum CD3, CD4, CD8 in lymphocytes and the ratio of CD4/CD8 were compared between the study and the control group before operation. The levels of HBD-2, IFN-γ, IL-4, IL-6 cytokines in the adenoid were compared between the control group and the observation group. The expression and distribution of adenoid HBD-2, IFN-γ, IL-4, IL-6 were compared between the control group and the observation group.  Result: After 12 weeks of treatment, the total effective rate of the observation group was significantly higher than that of the control group, and the improvement of sleep respiratory obstruction symptoms of children with recurrent upper respiratory tract infection and adenoid hypertrophy was also much better than that of the control group. The serum IFN-γ of the observation group was significantly higher than that of the control group, and there was no significant difference in serum IL-2, IL-4, IL-6, IL-10, TNF, IgE between the observation group and the control group. There was no significant difference in serum CD3, CD4, CD8 and CD4/CD8 between the observation group and the control group. In the observation group, the adenoid HBD-2 was significantly higher but IL-4, IFN-γ were significantly lower than that in the control group, and IL-6 had no significant difference compared with the control group.  Conclusion: OM85-BV can significantly improve the sleep apnea symptoms but can not rise the level of immune lymphocytes in children with adenoid hypertrophy and recurrent upper respiratory tract infection.OM85-BV can improve the Th1 immune response, enhancing the ability of human body to fight against pathogens and induce the release of HBD-2, increasing the resistance to microorganisms, reducing the bacteria aggregation, weakening the local inflammatory response in adenoids.",2020,"In the observation group, the adenoid HBD-2 was significantly higher but IL-4, IFN-γ were significantly lower than that in the control group, and IL-6 had no significant difference compared with the control group.  ","['children with adenoid hypertrophy and recurrent upper respiratory tract infection', 'Four hundred and forty-eight children with recurrent upper respiratory tract infection and adenoid hypertrophy were collected']","['OM85-BV+conventional drugs', 'conventional drugs', 'OM85-BV']","['adenoid HBD-2', 'sleep obstructive symptoms of adenoid hypertrophy', 'serum IFN-γ', 'levels of serum IL-2, IL-4, IL-6, IL-10, TNF, IFN-γ and IgE, the ratio of serum CD3, CD4, CD8 in lymphocytes and the ratio of CD4/CD8', 'total effective rate', 'expression and distribution of adenoid HBD-2, IFN-γ, IL-4, IL-6', 'serum IL-2, IL-4, IL-6, IL-10, TNF, IgE', 'sleep apnea symptoms', 'levels of HBD-2, IFN-γ, IL-4, IL-6 cytokines', 'sleep respiratory obstruction symptoms', 'serum CD3, CD4, CD8 and CD4/CD8', 'symptoms scores and effective rate', 'IL-4, IFN-γ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0581381', 'cui_str': 'Recurrent upper respiratory tract infection'}, {'cui': 'C4517777', 'cui_str': '440'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",448.0,0.0196118,"In the observation group, the adenoid HBD-2 was significantly higher but IL-4, IFN-γ were significantly lower than that in the control group, and IL-6 had no significant difference compared with the control group.  ","[{'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Karamay Central Hospital，Xinjiang Autonomous Region.'}, {'ForeName': 'Jiahua', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Cao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery，Children's Hospital Affiliated to Zhejiang University Medical College，Hangzhou，310052，China.""}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.06.005']
1950,32842183,[The efficacy of hyperbaric oxygen in the treatment of sudden sensorineural hearing loss].,"Objective: To investigate the therapeutic effect of hyperbaric oxygen on sudden sensorineural hearing loss（SSNHL）.  Method: One hundred and seven patients with SSNHL were selected, and were randomly divided into 3 groups according to admission order. Therapeutic schedule in group A （38 cases） consisted of hyperbaric oxygen treatment once a day for 10 consecutive days, then 1 day off treatment, and on treatment for another 10 consecutive days （20 treatments in total）. Twenty-seven patients in group B were treated with hyperbaric oxygen twice per day for a total of 10 days. Forty-two patients in group C didn't receive hyperbaric oxygen therapy. Meanwhile, all patients were given conventional treatment for 14 days in accordance with the recommendations of the otolaryngology, head and neck branch of the Chinese medical association for the diagnosis and treatment of sudden sensorineural hearing loss. Patients in group A underwent pure tone audiometry after the end of treatment, and patients in group B and C were reexamined 20 days after the start of treatment, and the treatment efficacy of the three groups was compared.  Result: The overall effective rate of group A was 78.9%, and the improvement of hearing threshold was（27.2±17.5） dB HL. In group B, the overall effective rate was 81.5%, and the improvement of threshold value was（26.9±16.7） dB HL. The overall effective rate of group C was 61.9%, and the improvement of threshold value o was（17.6±18.5） dB HL. The effective rate of group C was significantly higher than that of group A or B, while there was no significant difference in efficacy between group A and group B.  Conclusion: The efficacy of hyperbaric oxygen combined with drug therapy for SSNHL is better than that of drug therapy alone. Programs of different hyperbaric oxygen combined with drug therapy can be selected on an individual basis.",2020,"The effective rate of group C was significantly higher than that of group A or B, while there was no significant difference in efficacy between group A and group B.  Conclusion:","['sudden sensorineural hearing loss', 'One hundred and seven patients with SSNHL', 'sudden sensorineural hearing loss（SSNHL）']","['hyperbaric oxygen treatment', 'hyperbaric oxygen combined with drug therapy', 'hyperbaric oxygen therapy', 'hyperbaric oxygen']","['overall effective rate', 'efficacy', 'hearing threshold was（27.2±17.5', 'effective rate']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",107.0,0.016149,"The effective rate of group C was significantly higher than that of group A or B, while there was no significant difference in efficacy between group A and group B.  Conclusion:","[{'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}, {'ForeName': 'Hongjiang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}, {'ForeName': 'Wenfang', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery，Chongqing General Hospital，Chongqing，400013，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.06.010']
1951,32842188,"[Efficacy and safety of pulmicort repulas-impregnated nasal dressing following endoscopic sinus surgery: a randomized, single-blind, placebo-controlled study].","Objective: To investigate the efficacy and safety of pulmicort respulas immerse with nasopore as nasal packing after nasal endoscopic surgery on patients with chronic rhinosinusitis with nasal polyps.  Method: This single-blind, randomized study recruit 33 patients diagnosed as chronic rhinosinusitis with polyposis. All of them underwent bilateral endoscopic sinus surgery and randomized to receive pulmicort respulas immersed nasopore in one nasal cavity and saline immersed nasopore contralaterally. Both groups were followed up at 2, 4, 8, 12, 24 weeks after operation. Subjective （VAS score） and objective （Lund-Kennedy score） scores are collected at each time point from both sides of nasal cavity.  Result: There are 30 enrolled patients in the study completed the 24-week trial. Both the subjective and objective scores of two groups shows a significant reduction after the ESS operation. The VAS score of the two groups remains roughly unchanged during week 2 to week 24. A statistically significant difference of the Lund-Kennedy score can be detected between the groups from week 2 to week 24. Though the serum cortisol reduced （5.97±4.10） mmol/L vs （12.48±4.33） mmol/L after the surgery, neither group shows any clinical symptoms related with the hypothalamic-pituitary-adrenal axis suppression.  Conclusion: This study demonstrated a significant improvement in postoperative healing in nasal cavities receiving pulmicort respulas immersed nasopore as nasal packing following ESS. This method of using budesonide is generally safe for patients with chronic rhinosinusitis with polyposis.",2020,A statistically significant difference of the Lund-Kennedy score can be detected between the groups from week 2 to week 24.,"['patients with chronic rhinosinusitis with polyposis', '33 patients diagnosed as chronic rhinosinusitis with polyposis', '30 enrolled patients in the study completed the 24-week trial', 'endoscopic sinus surgery', 'patients with chronic rhinosinusitis with nasal polyps']","['pulmicort repulas-impregnated nasal dressing', 'pulmicort respulas immersed nasopore in one nasal cavity and saline immersed nasopore contralaterally', 'bilateral endoscopic sinus surgery', 'budesonide', 'placebo', 'pulmicort respulas immerse with nasopore as nasal packing after nasal endoscopic surgery']","['Lund-Kennedy score', 'efficacy and safety', 'VAS score', 'serum cortisol', 'postoperative healing', 'Subjective （VAS score） and objective （Lund-Kennedy score） scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0678162', 'cui_str': 'Pulmicort'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0027423', 'cui_str': 'Nasal cavity structure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",33.0,0.0277363,A statistically significant difference of the Lund-Kennedy score can be detected between the groups from week 2 to week 24.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Zhenxiao', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Mingjie', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Nianci', 'Initials': 'N', 'LastName': 'Xiao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Beijing Tongren Hospital，Capital Medical University，Beijing，100730，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.06.015']
1952,32843205,Improving Door-to-Balloon Time for Patients With Acute ST-Elevation Myocardial Infarction: A Controlled Clinical Trial.,"According to the latest guidelines, the best intervention to restore blood flow through occluded coronary arteries is angioplasty at a time less than 90 minutes. Thereby, the present study was conducted to determine the impact of implementing ST-elevation myocardial infarction (STEMI) code on door-to-balloon time in patients with ST-segment elevation myocardial infarction. This clinical trial was conducted in 2019 at Booali Sina heart center hospital in Qazvin, Iran, in 2019. Fifty-eight patients with STEMI were purposively and consecutively enrolled in the study. Patients were then divided into control and intervention groups, based on their referral period. In both groups, patients were observed since their Arrived by emergency medical services to emergency department until inflating the balloon in the occluded coronary artery, and the intended times were recorded by the researchers. For Participants in the intervention group the ""STEMI code"" was designed and activated by an emergency physician once there is a patient experiencing a chest pain and early confirmed as a myocardial infarction. The SPSS program (v. 16) was used for data analysis at a significance level of less than 0.05. The difference in the door-to-balloon mean time in both control (113.5 ± 43.6 minutes) and intervention (79.3 ± 27.4 minutes) groups, was statistically significant (P = 0.001). Regarding other parameters, the reduction in the mean between Cath lab time (26.2 ± 18.2 minutes) and balloon time (15.5 ± 7.8 minutes) was also statistically significant (P = 0.008). In this study, implementation of the ""STEMI code"" could greatly prevent parallel work and squandering time while treating patients with acute myocardial infarction. As the door-to-balloon time gets shorter, the bed occupancy rate in the emergency department had reduced which in turn allowed more patients to be admitted.",2020,"The difference in the door-to-balloon mean time in both control (113.5 ± 43.6 minutes) and intervention (79.3 ± 27.4 minutes) groups, was statistically significant (P = 0.001).","['patients with ST-segment elevation myocardial infarction', 'patients with acute myocardial infarction', 'Patients With Acute ST-Elevation Myocardial Infarction', 'Fifty-eight patients with STEMI were purposively and consecutively enrolled in the study', '2019 at Booali Sina heart center hospital in Qazvin, Iran, in 2019']",[],"['door-to-balloon mean time', 'bed occupancy rate', 'balloon time', 'mean between Cath lab time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004909', 'cui_str': 'Bed Occupancy'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",58.0,0.0152122,"The difference in the door-to-balloon mean time in both control (113.5 ± 43.6 minutes) and intervention (79.3 ± 27.4 minutes) groups, was statistically significant (P = 0.001).","[{'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Namdar', 'Affiliation': ''}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'YekeFallah', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jalalian', 'Affiliation': ''}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Barikani', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Razaghpoor', 'Affiliation': ''}]",Current problems in cardiology,['10.1016/j.cpcardiol.2020.100674']
1953,32844795,Effectiveness of Pressurized Normal Saline Irrigation of Subcutaneous Tissue Following Appendicectomy in Decreasing Wound Infection: A Quasi Experimental Study.,"Acute appendicitis is the commonest cause of acute abdomen necessitating surgical intervention and wound infection is the most frequently encountered complication following appendicectomy. To assess the effectiveness of pressurized normal saline irrigation of subcutaneous tissue following appendicectomy in decreasing wound infection this quasi experimental study was done in Surgery Unit III, Mymensingh Medical College Hospital from January 2018 to December 2018. In this study total 200 patients of acute appendicitis were enrolled according to inclusion and exclusion criteria and assigned equally into two groups by non-equivalent control group design. In control group all the standard protocol of wound closure following appendicectomy was followed and in experimental group along with the standard protocol the subcutaneous tissue was irrigated by pressure with normal saline and all the data were recorded in individual case record form. Among the sample most of the patients were between 10-19 years of ages and the male female ratio was 1.38:1. In control group 30% patients developed wound infection while 12% patients developed wound infection in experimental group with a P value of 0.027. Mean hospital stay of experimental group was less than the control group (P value less than 0.05). Overall postoperative outcome in context of wound infection and hospital stay is better following pressurized normal saline irrigation of subcutaneous tissue during closure.",2020,Overall postoperative outcome in context of wound infection and hospital stay is better following pressurized normal saline irrigation of subcutaneous tissue during closure.,"['Surgery Unit III, Mymensingh Medical College Hospital from January 2018 to December 2018', '200 patients of acute appendicitis', 'sample most of the patients were between 10-19 years of ages and the male female ratio was 1.38:1']","['pressurized normal saline irrigation', 'Pressurized Normal Saline Irrigation of Subcutaneous Tissue Following Appendicectomy']","['Wound Infection', 'Mean hospital stay', 'wound infection and hospital stay', 'wound infection']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]","[{'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",200.0,0.0381785,Overall postoperative outcome in context of wound infection and hospital stay is better following pressurized normal saline irrigation of subcutaneous tissue during closure.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Reza', 'Affiliation': 'Dr Ehsanur Reza, Associate Professor, Department of Surgery, Mymensingh Medical College, Mymensingh, Bangladesh.'}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Emon', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bhuiyan', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Habib', 'Affiliation': ''}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Khan', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1954,32844806,Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial.,"Optimal enteral nutrition is essential for growth restricted preterm infants because if nutrition remains suboptimal during early days of life, physical and neuro-developmental outcome might be in danger. However, chronic hypoxia during antenatal period makes them susceptible for feeding intolerance and necrotising enterocolitis during post natal period. So this randomized clinical trial was conducted in the department of Neonatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from January 2018 to June 2019; to evaluate the effect of early versus delayed enteral feeding on preterm growth-restricted infants. During the study period, out of 127 infants with small for gestational age, 50 babies were enrolled and randomly assigned to either early feeding group (n=25) or late feeding group (n=25). Clinical characteristics at trial entry were well balanced between groups. Newborn enrolled in early feeding group reached full feed significantly faster than late feeding group (p=0.001; Hazard ratio 1.24). Early feeding group regained birth weight faster; experienced lesser incidence of neonatal sepsis, experienced less number of feed intolerance, had shorter mean duration of hospital stay and achieved higher weight on post natal age 16th days. All values were statistically significant. Early enteral feeding found to be safe and beneficial in reducing the time to reach full enteral feeding and better weight gain in growth restricted preterm infants.",2020,"Early feeding group regained birth weight faster; experienced lesser incidence of neonatal sepsis, experienced less number of feed intolerance, had shorter mean duration of hospital stay and achieved higher weight on post natal age 16th days.","['127 infants with small for gestational age, 50 babies', 'preterm growth-restricted infants', 'department of Neonatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from January 2018 to June 2019', 'Preterm Growth-Restricted Infants', 'growth restricted preterm infants']","['delayed enteral feeding', 'early feeding group (n=25) or late feeding group', 'Delayed Enteral Feeding']","['mean duration of hospital stay', 'neonatal sepsis, experienced less number of feed intolerance', 'weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0027621', 'cui_str': 'Neonatology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",127.0,0.0470463,"Early feeding group regained birth weight faster; experienced lesser incidence of neonatal sepsis, experienced less number of feed intolerance, had shorter mean duration of hospital stay and achieved higher weight on post natal age 16th days.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ahmed', 'Affiliation': 'Dr Farzana Ahmed, Associate Professor & Head, Department of Paediatrics, Marks Medical College Hospital, Dhaka, Bangladesh; E-mail: farzanaahmedpaed@gmail.com.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Dey', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shahidullah', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Mannan', 'Affiliation': ''}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Raj', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sharmin', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1955,32844807,A Comparative Study Between 20% Mannitol and 3% Hypertonic Saline for Brain Oedema Reduction during Elective Brain Tumour Surgery.,"Cerebral oedema is an important manifestation of brain tumour. The significant reduction of cerebral oedema can show rapid improvement of the patients. Hypertonic saline solution and mannitol both are commonly used for this action. It is now time to choose the better one. This was a prospective randomized comparative study designed to evaluate the efficacy of 3% hypertonic saline (NaCl) in reduction of brain oedema during brain tumour surgery and compare it with that of 20% Mannitol. The study was conducted in the department of Anaesthesiology, Combined Military Hospital, Dhaka, Bangladesh from July 2016 to December 2016. A total number of 47 patients for brain tumour surgery were selected. After screening 40 patients were finalized. Then the patients were divided into 2 equal groups 20 patients in each. Patients of Group A received 3% hypertonic saline and Group B 20% mannitol. Uniform anaesthetic technique applied for all patients, fixed surgeon/group of surgeons carried out the surgery. Heart rate and noninvasive blood pressure were monitored and kept with in ±20% baseline values different means. ETCO2 were kept in between 28-32mm of Hg by adjusting ventilator setting. Reduction of brain oedema was monitored by subjective assessment of surgeons using a 3 point scale of brain relaxation. The data were recorded in preformed data sheet. The results were tested by chi-square test to see their level of significance i.e. p value <0.05 was considered as significant. At the opening of dura, the number of brain conditions classified as soft, adequate and tight were statistically non-significant between groups. After 0.5 hour and 1.0 hour 10% patient's brain was tight in Group A whereas it was 35% and 40% in Group B respectively. Reduction of brain oedema or brain relaxation was significantly better in Group A compared to Group B (p<0.05). Urine output was higher with mannitol than hypertonic saline (p<0.05). Duration of ICU and hospital stay in both Group A and Group B were statistically similar (p>0.05). Compared to mannitol, hypertonic saline caused an increase in serum sodium concentration over time (p<0.05). From the available data, use of 20% mannitol and 3% hypertonic saline for brain oedema reduction, it is suggested that hypertonic saline significantly reduces the risk of tight brain and produce the brain more soft than mannitol during brain tumour surgery.",2020,Reduction of brain oedema or brain relaxation was significantly better in Group A compared to Group B (p<0.05).,"['47 patients for brain tumour surgery', 'department of Anaesthesiology, Combined Military Hospital, Dhaka, Bangladesh from July 2016 to December 2016']","['hypertonic saline and Group B 20% mannitol', '20% Mannitol', 'hypertonic saline (NaCl', 'Mannitol and 3% Hypertonic Saline', 'Hypertonic saline solution and mannitol', 'hypertonic saline', 'mannitol, hypertonic saline']","['Cerebral oedema', 'Heart rate and noninvasive blood pressure', 'risk of tight brain', 'serum sodium concentration', 'Urine output', 'brain oedema or brain relaxation', 'cerebral oedema', 'Duration of ICU and hospital stay', 'brain oedema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",40.0,0.0234874,Reduction of brain oedema or brain relaxation was significantly better in Group A compared to Group B (p<0.05).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haque', 'Affiliation': 'Major Dr Ariful Haque, Major, Classified Anaesthesiologist, Department of Anaesthesiology, CMH Savar, Savar Cantonment, Dhaka, Bangladesh; E-mail: haque_arif@yahoo.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Khalilullah', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Haque', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nancy', 'Affiliation': ''}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Ullah', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tusher', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jahan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abedin', 'Affiliation': ''}]",Mymensingh medical journal : MMJ,[]
1956,31534016,Immune correlates of the Thai RV144 HIV vaccine regimen in South Africa.,"One of the most successful HIV vaccines to date, the RV144 vaccine tested in Thailand, demonstrated correlates of protection including cross-clade V1V2 immunoglobulin G (IgG) breadth, Env-specific CD4 +  T cell polyfunctionality, and antibody-dependent cellular cytotoxicity (ADCC) in vaccinees with low IgA binding. The HIV Vaccine Trials Network (HVTN) 097 trial evaluated this vaccine regimen in South Africa, where clade C HIV-1 predominates. We compared cellular and humoral responses at peak and durability immunogenicity time points in HVTN 097 and RV144 vaccinee samples, and evaluated vaccine-matched and cross-clade immune responses. At peak immunogenicity, HVTN 097 vaccinees exhibited significantly higher cellular and humoral immune responses than RV144 vaccinees. CD4 +  T cell responses were more frequent in HVTN 097 irrespective of age and sex, and CD4 +  T cell Env-specific functionality scores were higher in HVTN 097. Env-specific CD40L +  CD4 +  T cells were more common in HVTN 097, with individuals having this pattern of expression demonstrating higher median antibody responses to HIV-1 Env. IgG and IgG3 binding antibody rates and response magnitude to gp120 vaccine- and V1V2 vaccine-matched antigens were higher or comparable in HVTN 097 than in RV144 ADCC, and ADCP functional antibody responses were elicited in HVTN 097. Env-specific IgG and CD4 +  Env responses declined significantly over time in both trials. Overall, cross-clade immune responses associated with protection were better than expected in South Africa, suggesting wider applicability of this regimen.",2019,"At peak immunogenicity, HVTN 097 vaccinees exhibited significantly higher cellular and humoral immune responses than RV144 vaccinees.","['South Africa, where clade C HIV-1 predominates', 'Immune correlates of the Thai RV144 HIV vaccine regimen in South Africa']","['Env-specific CD40L +  CD4 ', 'vaccine- and V1V2']","['CD4 +  T cell responses', 'CD4 +  T cell Env-specific functionality scores', 'protection including cross-clade V1V2 immunoglobulin G (IgG) breadth, Env-specific CD4 +  T cell polyfunctionality, and antibody-dependent cellular cytotoxicity (ADCC', 'cellular and humoral immune responses', 'ADCP functional antibody responses']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0167627', 'cui_str': 'Lymphocyte antigen CD154'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003272', 'cui_str': 'Antibody-dependent cellular cytotoxicity'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",,0.0672284,"At peak immunogenicity, HVTN 097 vaccinees exhibited significantly higher cellular and humoral immune responses than RV144 vaccinees.","[{'ForeName': 'Glenda E', 'Initials': 'GE', 'LastName': 'Gray', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa. glenda.gray@mrc.ac.za.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Laher', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa.'}, {'ForeName': 'Surita', 'Initials': 'S', 'LastName': 'Roux', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town 8001, South Africa.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Andersen-Nissen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'De Rosa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Flach', 'Affiliation': 'Cape Town HVTN Immunology Laboratory, Hutchinson Centre Research Institute of South Africa, Cape Town 8001, South Africa.'}, {'ForeName': 'April K', 'Initials': 'AK', 'LastName': 'Randhawa', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Jensen', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Edith M', 'Initials': 'EM', 'LastName': 'Swann', 'Affiliation': 'Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20852, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town 8001, South Africa.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Innes', 'Affiliation': 'The Aurum Institute, Klerksdorp 2570, South Africa.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Lazarus', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morris', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Sandringham, Johannesburg 2192, South Africa.'}, {'ForeName': 'Nonhlanhla N', 'Initials': 'NN', 'LastName': 'Mkhize', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Sandringham, Johannesburg 2192, South Africa.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC 27710, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC 27710, USA.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC 27710, USA.'}, {'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Sawant', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC 27710, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Yates', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC 27710, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Isaacs', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA 18370, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA 18370, USA.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Sinangil', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC 27710, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}]",Science translational medicine,['10.1126/scitranslmed.aax1880']
1957,32869931,Efficacy and safety of a topical moisturizer containing linoleic acid and ceramide for mild-to-moderate psoriasis vulgaris: A multicenter randomized controlled trial.,"Psoriasis is a chronic, recurrent skin disease requiring long-term management. Agents that repair the skin's barrier function are invaluable additives in topical treatments of psoriasis. This multicenter, randomized, controlled trial evaluated the efficacy and safety of a linoleic acid-ceramide-containing moisturizer (LA-Cer) for mild-to-moderate psoriasis vulgaris. We randomized 178 patients from both northern and southern regions of China into two groups: 81 patients in the control group received mometasone furoate (MF, 0.1%) cream, while MF in combination with LA-Cer was administered to 86 patients in the treatment group for 4 weeks. The LA-Cer-MF group maintained the use of moisturizer after topical glucocorticoid administration. The primary endpoint, Psoriasis Area and Severity Index 50 (PASI 50) response, revealed the superiority of LA-Cer-MF with lower relapse rates at week 8. The use of the LA-Cer-containing moisturizer as maintenance therapy resulted in a continuous improvement in the clinical state in terms of body surface area, PASI, investigators' assessment of skin dryness and desquamation, and Physician Global Assessment of Psoriasis score, and in the patients' quality of life. Thus, the LA-Cer-containing moisturizer is a promising agent to prevent and treat psoriasis as it enhances the therapeutic effect induced by topical glucocorticoids and delays relapse.",2020,"The primary endpoint, Psoriasis Area and Severity Index 50 (PASI 50) response, revealed the superiority of LA-Cer-MF with lower relapse rates at week 8.","['Mild-To-Moderate Psoriasis Vulgaris', 'psoriasis', 'mild-to-moderate psoriasis vulgaris', '178 patients from both northern and southern regions of China into two groups: 81 patients in the control group received']","['Topical moisturizer containing Linoleic Acid and Ceramide', 'mometasone furoate (MF, 0.1%) cream, while MF in combination with LA-Cer', 'linoleic acid-ceramide-containing moisturizer (LA-Cer']","['skin dryness and desquamation, and Physician Global Assessment of Psoriasis score', 'Efficacy and Safety', 'Psoriasis Area and Severity Index 50 (PASI 50) response, revealed the superiority of LA-Cer-MF with lower relapse rates']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",178.0,0.052867,"The primary endpoint, Psoriasis Area and Severity Index 50 (PASI 50) response, revealed the superiority of LA-Cer-MF with lower relapse rates at week 8.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Laboratory of Dermatoimmunology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Dermatology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Hongzhong', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ai-E', 'Initials': 'AE', 'LastName': 'Xu', 'Affiliation': ""Department of Dermatology, Third People's Hospital of Hangzhou, Hangzhou, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Dermatology, Third People's Hospital of Hangzhou, Hangzhou, China.""}, {'ForeName': 'Junling', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjing, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjing, China.'}, {'ForeName': 'Zaipei', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, Institute of Medical Sciences, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Institute of Medical Sciences, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Dermatologic therapy,['10.1111/dth.14263']
1958,32870298,Effect of Intraoperative Low Tidal Volume vs Conventional Tidal Volume on Postoperative Pulmonary Complications in Patients Undergoing Major Surgery: A Randomized Clinical Trial.,"Importance


In patients who undergo mechanical ventilation during surgery, the ideal tidal volume is unclear.
Objective


To determine whether low-tidal-volume ventilation compared with conventional ventilation during major surgery decreases postoperative pulmonary complications.
Design, Setting, and Participants


Single-center, assessor-blinded, randomized clinical trial of 1236 patients older than 40 years undergoing major noncardiothoracic, nonintracranial surgery under general anesthesia lasting more than 2 hours in a tertiary hospital in Melbourne, Australia, from February 2015 to February 2019. The last date of follow-up was February 17, 2019.
Interventions


Patients were randomized to receive a tidal volume of 6 mL/kg predicted body weight (n = 614; low tidal volume group) or a tidal volume of 10 mL/kg predicted body weight (n = 592; conventional tidal volume group). All patients received positive end-expiratory pressure (PEEP) at 5 cm H2O.
Main Outcomes and Measures


The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, including pneumonia, bronchospasm, atelectasis, pulmonary congestion, respiratory failure, pleural effusion, pneumothorax, or unplanned requirement for postoperative invasive or noninvasive ventilation. Secondary outcomes were postoperative pulmonary complications including development of pulmonary embolism, acute respiratory distress syndrome, systemic inflammatory response syndrome, sepsis, acute kidney injury, wound infection (superficial and deep), rate of intraoperative need for vasopressor, incidence of unplanned intensive care unit admission, rate of need for rapid response team call, intensive care unit length of stay, hospital length of stay, and in-hospital mortality.
Results


Among 1236 patients who were randomized, 1206 (98.9%) completed the trial (mean age, 63.5 years; 494 [40.9%] women; 681 [56.4%] undergoing abdominal surgery). The primary outcome occurred in 231 of 608 patients (38%) in the low tidal volume group compared with 232 of 590 patients (39%) in the conventional tidal volume group (difference, -1.3% [95% CI, -6.8% to 4.2%]; risk ratio, 0.97 [95% CI, 0.84-1.11]; P = .64). There were no significant differences in any of the secondary outcomes.
Conclusions and Relevance


Among adult patients undergoing major surgery, intraoperative ventilation with low tidal volume compared with conventional tidal volume, with PEEP applied equally between groups, did not significantly reduce pulmonary complications within the first 7 postoperative days.
Trial Registration


ANZCTR Identifier: ACTRN12614000790640.",2020,"Secondary outcomes were postoperative pulmonary complications including development of pulmonary embolism, acute respiratory distress syndrome, systemic inflammatory response syndrome, sepsis, acute kidney injury, wound infection (superficial and deep), rate of intraoperative need for vasopressor, incidence of unplanned intensive care unit admission, rate of need for rapid response team call, intensive care unit length of stay, hospital length of stay, and in-hospital mortality.
","['adult patients undergoing major surgery', '1236 patients older than 40 years undergoing major noncardiothoracic, nonintracranial surgery under general anesthesia lasting more than 2 hours in a tertiary hospital in Melbourne, Australia, from February 2015 to February 2019', '1236 patients who were randomized, 1206 (98.9%) completed the trial (mean age, 63.5 years; 494 [40.9%] women; 681 [56.4%] undergoing abdominal surgery', 'Patients Undergoing Major Surgery']","['Intraoperative Low Tidal Volume vs Conventional Tidal Volume', 'low-tidal-volume ventilation', 'intraoperative ventilation with low tidal volume', 'positive end-expiratory pressure (PEEP) at 5 cm H2O', 'tidal volume of 6 mL/kg predicted body weight (n\u2009=\u2009614; low tidal volume group) or a tidal volume of 10 mL/kg predicted body weight (n\u2009=\u2009592; conventional tidal volume group', 'conventional ventilation']","['pulmonary complications', 'Postoperative Pulmonary Complications', 'composite of postoperative pulmonary complications within the first 7 postoperative days, including pneumonia, bronchospasm, atelectasis, pulmonary congestion, respiratory failure, pleural effusion, pneumothorax, or unplanned requirement for postoperative invasive or noninvasive ventilation', 'postoperative pulmonary complications including development of pulmonary embolism, acute respiratory distress syndrome, systemic inflammatory response syndrome, sepsis, acute kidney injury, wound infection (superficial and deep), rate of intraoperative need for vasopressor, incidence of unplanned intensive care unit admission, rate of need for rapid response team call, intensive care unit length of stay, hospital length of stay, and in-hospital mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0242073', 'cui_str': 'Pulmonary congestion'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2718033', 'cui_str': 'Hospital Medical Emergency Team'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",1236.0,0.446089,"Secondary outcomes were postoperative pulmonary complications including development of pulmonary embolism, acute respiratory distress syndrome, systemic inflammatory response syndrome, sepsis, acute kidney injury, wound infection (superficial and deep), rate of intraoperative need for vasopressor, incidence of unplanned intensive care unit admission, rate of need for rapid response team call, intensive care unit length of stay, hospital length of stay, and in-hospital mortality.
","[{'ForeName': 'Dharshi', 'Initials': 'D', 'LastName': 'Karalapillai', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Peyton', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ellard', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Pearce', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chong O', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Story', 'Affiliation': 'Department of Anesthesia, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hamilton', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Oughton', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Galtieri', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daryl A', 'Initials': 'DA', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesia, Austin Hospital, Melbourne, Victoria, Australia.'}]",JAMA,['10.1001/jama.2020.12866']
1959,32839158,Correction: Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.,,2020,,['heterosexual couples'],"['HPV vaccination ', 'HPV vaccination']",[],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.0545783,,[],BMJ open,['10.1136/bmjopen-2020-039383corr1']
1960,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
1961,32836063,"Efficacy of scalp nerve blocks using ropivacaïne 0,75% associated with intravenous dexamethasone for postoperative pain relief in craniotomies.","Pain after supratentorial craniotomy is common, 55 % to 80 % of patients experience moderate to severe pain in the first 48 h(1-7). The importance of intravenous dexamethasone as an adjuvant to local anaesthetics is increasingly applied(1-7), however its role in scalp nerve blocks with ropivacaine 0.75 % remains unexplored in post-operative analgesia. We analyzed 134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with ropivacaine 0.75 %. The general anaesthesia was standardized and included 8 mg of intravenous dexamethasone at the induction. The postoperative pain was assessed using the numerical rating scale with patients in the post anaesthesia care unit and subsequently every 8 h in the neurosurgery unit until the 48th hour. A NRS value above 3 led to the administration of a rescue analgesic according to the defined protocol until an efficient analgesia was obtained. Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group. More than 60 % of the patients from the scalp nerve blocks group had an efficient analgesia without any rescue analgesic. Peroperatively the scalp nerve blocks group showed a decrease in opioid consumption and a better hemodynamic stability. No anesthetic or chirurgical complications related to the use of scalp blocks were observed. Scalp nerve blocks associated with intravenous dexamethasone are found to be a straightforward and efficient analgesic approach during supratentorial craniotomies.",2020,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","['134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with', 'craniotomies']","['dexamethasone', 'ropivacaïne', 'ropivacaine']","['efficient analgesia without any rescue analgesic', 'postoperative pain relief', 'severe pain', 'hemodynamic stability', 'Postoperative pain', 'Pain', 'opioid consumption', 'postoperative pain']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",134.0,0.065171,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gaudray', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: eliott.gaudray@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""N' Guyen"", 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: cedric1.nguyen@intradef.gouv.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: edouard1.martin@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lyochon', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: arthur.lyochon@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dagain', 'Affiliation': 'Department of Neurosurgery, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: arnaud.dagain@intradef.gouv.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bordes', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: julien.bordes@intradef.gouv.fr.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Cordier', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: pierre-yves.cordier@intradef.gouv.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: guillaume.lacroix@intradef.gouv.fr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106125']
1962,32841219,Fc receptor-like 5 and anti-CD20 treatment response in granulomatosis with polyangiitis and microscopic polyangiitis.,"BACKGROUNDBaseline expression of FCRL5, a marker of naive and memory B cells, was shown to predict response to rituximab (RTX) in rheumatoid arthritis. This study investigated baseline expression of FCRL5 as a potential biomarker of clinical response to RTX in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).METHODSA previously validated quantitative PCR-based (qPCR-based) platform was used to assess FCRL5 expression in patients with GPA/MPA (RAVE trial, NCT00104299).RESULTSBaseline FCRL5 expression was significantly higher in patients achieving complete remission (CR) at 6, 12, and 18 months, independent of other clinical and serological variables, among those randomized to RTX but not cyclophosphamide-azathioprine (CYC/AZA). Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared with FCRL5lo subjects (84% versus 57% [P = 0.016], 68% versus 40% [P = 0.02], and 68% versus 29% [P = 0.0009], respectively).CONCLUSIONOur data taken together suggest that FCRL5 is a biomarker of B cell lineage associated with increased achievement and maintenance of complete remission among patients treated with RTX and warrant further investigation in a prospective manner.FUNDINGThe analysis for this study was funded by Genentech Inc.",2020,"Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared to FCRL5low subjects (84% vs 57% p=0.016, 68% vs 40% p=0.02 and 68% vs 29% p=0.0009, respectively).
","['granulomatosis with polyangiitis and microscopic polyangiitis', 'granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA', 'patients with GPA/MPA (RAVE trial, NCT00104299']","['RTX', 'FCRL5', 'rituximab (RTX']","['FCRL5 expression', 'Baseline FCRL5 expression', 'CR rates']","[{'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0968435', 'cui_str': 'FCRL5 protein, human'}]","[{'cui': 'C0968435', 'cui_str': 'FCRL5 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.0755829,"Patients with baseline FCRL5 expression ≥ 0.01 expression units (termed FCRL5hi) exhibited significantly higher CR rates at 6, 12, and 18 months as compared to FCRL5low subjects (84% vs 57% p=0.016, 68% vs 40% p=0.02 and 68% vs 29% p=0.0009, respectively).
","[{'ForeName': 'Kasia', 'Initials': 'K', 'LastName': 'Owczarczyk', 'Affiliation': ""Department of Cancer Imaging, King's College London, London, United Kingdom.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Cascino', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Holweg', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Gaik W', 'Initials': 'GW', 'LastName': 'Tew', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Ortmann', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Behrens', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'Hoffmann - La Roche, Basel, Switzerland.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Seo', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Cees Gm', 'Initials': 'CG', 'LastName': 'Kallenberg', 'Affiliation': 'University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Lim', 'Affiliation': 'Immune Tolerance Network (ITN), Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brunetta', 'Affiliation': 'Genentech, South San Francisco, California, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Prunotto', 'Affiliation': 'Hoffmann - La Roche, Basel, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.136180']
1963,32841904,Hyperarousal symptoms and perceived burdensomeness interact to predict suicidal ideation among trauma-exposed individuals.,"The association between posttraumatic stress disorder (PTSD) and suicidal ideation is well-established and recent prospective studies have demonstrated the unique role of hyperarousal symptoms. In particular, over-arousal may elevate suicide risk in the presence of interpersonal vulnerability factors including thwarted belongingness, perceived burdensomeness, and acquired capability. Therefore, the current study sought to examine the differential associations between PTSD symptom clusters and suicidality and the impact of interpersonal risk factors. Trauma-exposed adults (N = 247) completed a questionnaire battery at baseline and three-month follow-up, as part of a larger randomized controlled trial of computerized interventions for suicide risk. Given the focus of the current study, treatment condition was controlled for in all analyses. Results indicated that hyperarousal symptoms significantly predict suicidality, while reexperiencing and avoidance symptoms do not. Specifically, greater hyperarousal symptoms predicted increased suicidal ideation among individuals with high perceived burdensomeness. Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability. Taken together, findings suggest that assessment of hyperarousal symptoms and perceived burdensomeness may serve to identify trauma-exposed individuals at greater risk for suicide. Additionally, these factors may serve as effective intervention targets.",2020,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.",['Trauma-exposed adults (N\xa0=\xa0247) completed a'],['questionnaire battery at baseline and three-month follow-up'],"['hyperarousal symptoms', 'suicidal ideation', 'Hyperarousal symptoms']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",247.0,0.0289762,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Morabito', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA. Electronic address: Morabito@psy.fsu.edu.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Boffa', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Carter E', 'Initials': 'CE', 'LastName': 'Bedford', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Jimmy P', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'Furman University, 3300 Poinsett Hwy, Greenville, SC, USA, 29613.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.029']
1964,32842931,Help or flight? Increased threat imminence promotes defensive helping in humans.,"In humans and other mammals, defensive responses to danger vary with threat imminence, but it is unknown how those responses affect decisions to help conspecifics. Here, we manipulated threat imminence to investigate the impact of different defensive states on human helping behaviour. Ninety-eight healthy adult participants made trial-by-trial decisions about whether to help a co-participant avoid an aversive shock, at the risk of receiving a shock themselves. Helping decisions were prompted under imminent or distal threat, based on temporal distance to the moment of shock administration to the co-participant. Results showed that, regardless of how likely participants were to also receive a shock, they helped the co-participant more under imminent than distal threat. Reaction times and cardiac changes during the task supported the efficacy of the threat imminence manipulation in eliciting dissociable defensive states, with faster responses and increased heart rate during imminent compared to distal threats. Individual differences in empathic concern were specifically correlated with helping during imminent threats. These results suggest that defensive states driving active escape from immediate danger may also facilitate decisions to help others, potentially by engaging neurocognitive systems implicated in caregiving across mammals.",2020,"Reaction times and cardiac changes during the task supported the efficacy of the threat imminence manipulation in eliciting dissociable defensive states, with faster responses and increased heart rate during imminent compared to distal threats.",['Ninety-eight healthy adult participants'],[],"['Reaction times and cardiac changes', 'heart rate']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",98.0,0.0544391,"Reaction times and cardiac changes during the task supported the efficacy of the threat imminence manipulation in eliciting dissociable defensive states, with faster responses and increased heart rate during imminent compared to distal threats.","[{'ForeName': 'Joana B', 'Initials': 'JB', 'LastName': 'Vieira', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schellhaas', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim/Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Enström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Olsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.'}]",Proceedings. Biological sciences,['10.1098/rspb.2020.1473']
1965,32845223,Safety and Efficacy of Using Staplers and Vessel Sealing Devices for Laparoscopic Splenectomy: A Randomized Controlled Trial.,"Background.  Laparoscopic splenectomy (LS) is considered the operation of choice on elective basis for managing patients with certain hematological disorders. Hemostatic control of the splenic pedicle is one of the crucial steps in LS. This study compares the safety and efficacy of using endoscopic staplers and vessel sealing devices to control the splenic pedicle in patients with nonsevere splenomegaly.  Methods.  Fifty-one consecutive patients with different blood disorders including idiopathic thrombocytopenic purpura (ITP), hypersplenism, and lymphoma were randomized for elective LS. Traditional steps of LS, via lateral approach, were followed, and pedicle control was done with either endovascular gastrointestinal anastomosis stapler (n = 26) or vessel sealing device (Ligasure) (n = 25).  Results.  No difference was noted with different splenic spans when using either methods of pedicle control ( P  = .145). The volume of blood loss was higher in the Ligasure group compared to the staplers group (182 mL vs 131 mL, respectively), but was not statistically significant ( P  = .249). Conversion to open was notably higher in the Ligasure group ( P  = .034), but the intraoperative complications were comparable in both groups ( P  = .357).  Conclusion.  The use of vessel sealing devices for splenic pedicle control has comparable surgical outcomes compared with the use of endoscopic staplers for LS, but with higher rate of conversion to open surgery.",2020,"Conversion to open was notably higher in the Ligasure group ( P  = .034), but the intraoperative complications were comparable in both groups ( P  = .357).  ","['Laparoscopic Splenectomy', 'patients with nonsevere splenomegaly', 'Fifty-one consecutive patients with different blood disorders including idiopathic thrombocytopenic purpura (ITP), hypersplenism, and lymphoma', 'patients with certain hematological disorders']","['endovascular gastrointestinal anastomosis stapler (n = 26) or vessel sealing device (Ligasure', 'Staplers and Vessel Sealing Devices', 'Laparoscopic splenectomy (LS', 'endoscopic staplers and vessel sealing devices']","['intraoperative complications', 'Safety and Efficacy', 'safety and efficacy', 'volume of blood loss']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038002', 'cui_str': 'Splenomegaly'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0020532', 'cui_str': 'Hypersplenism'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0205423', 'cui_str': 'Certain'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C3874013', 'cui_str': 'Endoscopic stapler'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",51.0,0.0783226,"Conversion to open was notably higher in the Ligasure group ( P  = .034), but the intraoperative complications were comparable in both groups ( P  = .357).  ","[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Elmoatasembellah', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Senbel', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Fayez', 'Initials': 'F', 'LastName': 'Shahatto', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Eldamshety', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Mosab', 'Initials': 'M', 'LastName': 'Shetiwy', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdel Wahab', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Abouzid', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Setit', 'Affiliation': 'Surgical Oncology Unit, Oncology Center, Department of Surgery, 243489Mansoura University, Egypt.'}]",Surgical innovation,['10.1177/1553350620953023']
1966,32847382,Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial.,"BACKGROUND


Echo-guided percutaneous procedures have been reported reliable and advantageous. However, the learning curve is difficult for junior doctors. We aimed to evaluate the safety and efficacy of a novel guidewire (Panna wire) in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only.
METHODS


The Panna wire is designed for echo-guide procedure with a retractable spindle-shaped tip. A multicenter, randomized, controlled trial was conducted to evaluate the safety and efficacy of the Panna wire versus the conventional guidewire for junior doctors with <100 cases experience. The primary outcome was operative success rate. The secondary outcomes were incidence of major adverse events, operation time, time needed to enter the left atrium, number of arrhythmia episodes, number of misguidance to tricuspid valve, and incidence of peripheral vascular complications.
RESULTS


Between July 2018 and September 2019, 100 patients with atrial septal defect were randomized to either the Panna wire group (n=52) or the conventional wire group (n=48) at 3 centers. The baseline clinical characteristics were similarly distributed. The operative success rate (primary outcome) was 100% in the Panna wire group versus 68.75% in the conventional wire group ( P <0.001). No major adverse events occurred in either group. Significant differences in favor of the Panna wire group were found in operation time ( P =0.004), time needed to enter the left atrium ( P <0.001), number of arrhythmia episodes ( P <0.001), and number of misguidance to tricuspid valve ( P =0.005).
CONCLUSIONS


The Panna wire is safe and effective and reduces the learning curve in percutaneous atrial septal defect closure under transthoracic echocardiography guidance only. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04096924.",2020,"Significant differences in favor of the Panna wire group were found in operation time ( P =0.004), time needed to enter the left atrium ( P <0.001), number of arrhythmia episodes ( P <0.001), and number of misguidance to tricuspid valve ( P =0.005).
","['junior doctors with <100 cases experience', 'Between July 2018 and September 2019', 'Atrial Septal Defect Closure', '100 patients with atrial septal defect']","['conventional wire group', 'Panna wire group', 'novel guidewire (Panna wire', 'Panna wire versus the conventional guidewire', 'Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure']","['number of misguidance to tricuspid valve', 'safety and efficacy', 'operative success rate', 'adverse events', 'time needed to enter the left atrium', 'operation time', 'number of arrhythmia episodes', 'incidence of major adverse events, operation time, time needed to enter the left atrium, number of arrhythmia episodes, number of misguidance to tricuspid valve, and incidence of peripheral vascular complications']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040960', 'cui_str': 'Tricuspid valve structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0225860', 'cui_str': 'Left atrial structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0161817', 'cui_str': 'Peripheral vascular complication'}]",100.0,0.135079,"Significant differences in favor of the Panna wire group were found in operation time ( P =0.004), time needed to enter the left atrium ( P <0.001), number of arrhythmia episodes ( P <0.001), and number of misguidance to tricuspid valve ( P =0.005).
","[{'ForeName': 'Pengxu', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.), Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China.'}, {'ForeName': 'Guangzhi', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.), Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China.'}, {'ForeName': 'Zonggang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiac Surgery, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (Z.Z., W.Z.).""}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiac Surgery, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (Z.Z., W.Z.).""}, {'ForeName': 'Taibing', 'Initials': 'T', 'LastName': 'Fan', 'Affiliation': ""Department of Cardiovascular Surgery, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, China (T.F., Y.H.).""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Cardiovascular Surgery, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, China (T.F., Y.H.).""}, {'ForeName': 'Kunjing', 'Initials': 'K', 'LastName': 'Pang', 'Affiliation': 'Department of Echocardiography, Fuwai Hospital, National Center for Cardiovascular Diseases (K.P.), Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China.'}, {'ForeName': 'Shouzheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.), Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China.'}, {'ForeName': 'Fengwen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.), Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Biomaterial Research, Institute of Biomedical Engineering, Chinese Academy of Medical Sciences and Peking Union Medical College, China (W.W.).'}, {'ForeName': 'Shengshou', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.), Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Cardiovascular Surgery, National Center for Cardiovascular Disease, China and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (P.K., G.Z., S.W., F.Z., S.H., X.P.), Chinese Academy of Medical Sciences and Peking Union Medical College, Beilishilu, Xicheng District, Beijing, China.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009281']
1967,32852352,"Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naïve Children 2-9 Years of Age: A Phase III, Randomized Study.","BACKGROUND


Invasive meningococcal disease is a major cause of meningitis in children. An investigational meningococcal (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW-TT) could offer protection against invasive meningococcal disease in this population. This phase III study assessed the immunogenicity and safety of MenACYW-TT in children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria protein CRM197 (MenACWY-CRM).
METHODS


Healthy children 2-9 years of age in the United States, including Puerto Rico, were randomized (1:1) to receive MenACYW-TT (n = 499) or MenACWY-CRM (n = 501) (NCT03077438). Meningococcal antibody titers to the 4 vaccine serogroups were measured using a serum bactericidal antibody assay with human complement (hSBA) before and at day 30 after vaccination. Noninferiority between the vaccine groups was assessed by comparing seroresponse rates (postvaccination titers ≥1:16 when prevaccination titers were <1:8, or ≥4-fold increase if prevaccination titers were ≥1:8) to the 4 serogroups at day 30. Safety was monitored.
RESULTS


The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively). Geometric mean titers for serogroups C, W, and Y were higher with MenACYW-TT than for MenACWY-CRM. Both vaccines were well-tolerated and had similar safety profiles.
CONCLUSIONS


MenACYW-TT was well-tolerated in children and achieved noninferior immune responses to MenACWY-CRM against each of the 4 vaccine serogroups.",2020,"The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively).","['children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria protein CRM197 (MenACWY-CRM', '2-9 years of age in the United States, including Puerto Rico', 'Healthy children', 'Healthy Meningococcal-Naïve Children 2-9 Years of Age', 'children']","['toxoid conjugate vaccine (MenACYW-TT', 'MenACWY-CRM', 'Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT']","['immunogenicity and safety', 'Safety and Immunogenicity', 'proportion of participants achieving seroresponse', 'tolerated', 'Meningococcal antibody titers', 'seroresponse rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0056499', 'cui_str': 'CRM197 (non-toxic variant of diphtheria toxin)'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}]","[{'cui': 'C0040555', 'cui_str': 'Toxoid'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443678', 'cui_str': 'Meningococcal antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",501.0,0.106904,"The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively).","[{'ForeName': 'Carmen I', 'Initials': 'CI', 'LastName': 'Baccarini', 'Affiliation': 'From the Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Simon', 'Affiliation': 'Baptist Health, Nicholasville, KT.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Brandon', 'Affiliation': 'California Research Foundation, San Diego, CA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'J. Lewis Research, Inc., Salt Lake City, UT.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'From the Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'From the Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002832']
1968,32846062,A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.,"BACKGROUND


A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.
METHODS


In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.
RESULTS


A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
CONCLUSIONS


In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).",2020,"No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
","['children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump', 'children with type 1 diabetes', 'children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a', 'Children with Type 1 Diabetes', '101 children']","['Closed-Loop Control', 'closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group']","['median percentage of time that the system', 'diabetic ketoacidosis or severe hypoglycemia', 'median percentage of time that the glucose level', 'glycated hemoglobin levels', 'glycemic outcomes', 'mean (±SD) percentage of time that the glucose level', 'percentage of time that the glucose level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",101.0,0.0869124,"No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
","[{'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Schoelwer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Ruedy', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Jost', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Carria', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Emory', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Liana J', 'Initials': 'LJ', 'LastName': 'Hsu', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Oliveri', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Kollman', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Betsy B', 'Initials': 'BB', 'LastName': 'Dokken', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cherñavvsky', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004736']
1969,32853691,Development and validation of screening scores of non-alcoholic fatty liver disease in middle-aged and elderly Chinese.,"AIM


Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease and also closely related to cardiometabolic disease. Its prevalence was estimated at over one-fourth in the general population in China. We aimed to develop effective score tools for detecting NAFLD.
METHODS


A total of 17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis. All participants were randomly classified into the exploratory group or the validation group. Candidate categorical variables were selected using a logistic regression model. The score points were generated according to the β-coefficients.
RESULTS


We developed the Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I), which included body mass index and waist circumference with an area under the receiver-operating characteristic curve (AUC) of 0.802 (95% CI 0.792-0.811) in the exploratory group and 0.802 (95% CI 0.793-0.812) in the validation group. We further developed the SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC of 0.852 (95% CI 0.843-0.861) in the exploratory group and 0.843 (95% CI 0.834-0.852) in the validation group. The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
CONCLUSIONS


Based on anthropometric and clinical categorical variables, our two scores are effective tools for detecting NAFLD in both this southern Chinese population and their subpopulation with normal ALT levels.",2020,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","['subjects with normal alanine aminotransferase (ALT) levels', 'middle-aged and elderly Chinese', '17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis']",[],"['Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I', 'SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",17212.0,0.0822862,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","[{'ForeName': 'Yebei', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ""Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: houxuhong@sjtu.edu.cn.""}, {'ForeName': 'Peizhu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Fusong', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Lichang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Prevention and Health Care, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: wpjia@sjtu.edu.cn.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108385']
1970,32854150,Soybean-Oil Lipid Minimization for Prevention of Intestinal Failure-Associated Liver Disease in Late-Preterm and Term Infants With Gastrointestinal Surgical Disorders.,"BACKGROUND


Intestinal failure-associated liver disease (IFALD), a multifactorial disease, is common among infants with gastrointestinal surgical disorders (GISDs). Prolonged soy-based intravenous lipid emulsion (S-ILE) intake is associated with IFALD, but preventive studies of limiting S-ILE have been inconclusive. Furthermore, a double-blind, randomized preventive trial (DBRPT) of S-ILE intake has not been performed in infants with GISDs. Our objective was to compare the effect of 1 g/kg/d vs 2 g/kg/d S-ILE intake for 6 weeks on the incidence of IFALD and the rate of rise of direct bilirubin (DB) in infants with GISDs.
METHODS


A DBRPT was conducted in infants with GISDs at ≥34 weeks' gestational age (GA) admitted to the NICU within 72 hours after birth. Infants were randomized in a 1:1 ratio to receive either 1 or 2 g/kg/d S-ILE for 6 weeks. IFALD was defined as DB ≥2 mg/dL.
RESULTS


Forty infants were studied. The 2 groups had similar clinical characteristics except for GA and blood group incompatibility. Thirty percent of infants in each group developed IFALD (P = .94). However, infants in the group receiving 1 g/kg/d S-ILE (n = 20) had a lower rate of rise of DB compared with infants in the group receiving 2 g/kg/d S-ILE (n = 20).
CONCLUSIONS


Reducing S-ILE intake for 6 weeks in infants with GISD at ≥34 weeks' GA may not prevent IFALD. The extrapolated data on the rate of rise of DB suggest a possible risk of earlier development of IFALD with S-ILE intake of 2 g/kg/d, as compared with 1 g/kg/d, beyond the 6-week study period.",2020,30% of infants in each group developed IFALD (P = 0.94).,"['infants with GISDs', '≥ 34 weeks gestational age (GA) infants with GISDs', 'Late Preterm and Term Infants with Gastro-Intestinal Surgical Disorders', 'infants with gastrointestinal surgical disorders (GISDs', '34 weeks GA infants with GISDs admitted to the NICU within 72 hours after birth']","['Soybean Oil Lipid Minimization', 'Prolonged soy-based intravenous lipid emulsion (S-ILE']","['IFALD', 'rate of rise of DB', 'incidence of IFALD and the rate of rise of direct bilirubin (DB']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015667', 'cui_str': 'Lipid Emulsions, Intravenous'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",40.0,0.184114,30% of infants in each group developed IFALD (P = 0.94).,"[{'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, Division of Neonatal-Perinatal Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Hongyue', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Biostastics, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Sanjiv B', 'Initials': 'SB', 'LastName': 'Amin', 'Affiliation': 'Department of Pediatrics, Division of Neonatal-Perinatal Medicine, University of New Mexico, Albuquerque, New Mexico, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2004']
1971,32874044,Clinical Outcomes of Silk versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery.,"PURPOSE


The purpose is to compare the clinical results of using silk versus nylon sutures for conjunctival autograft suturing in pterygium surgery.
METHODS


In this prospective, randomized, controlled, clinical trial 50 eyes from 50 patients with primary nasal pterygium were randomized to undergo pterygium surgery with the use of either nylon sutures or silk sutures for conjunctival autograft suturing. Patients were followed up for 6 months. Main outcome measures included recurrence, postoperative discomfort according to a visual analog scale (VAS), graft hyperemia, and graft edema.
RESULTS


According to the results, there was no significant difference between groups regarding recurrence rate of pterygium ( P  = 0.72). A significant decrease in the mean VAS discomfort score from day 1 to day 14 was observed in both groups ( P  = 0.001); postoperative discomfort during the first 2 weeks, was not significantly different between the two groups. At 2 weeks' postoperatively, significantly greater number of nylon sutures remained on the autograft ( P  = 0.021), some of which were buried and could not be removed.
CONCLUSION


Both silk and nylon are effective suture materials for autograft suturing in pterygium surgery with similar postoperative discomfort and recurrence rate. Significantly greater number of nylon sutures remains buried on the autograft and could not be removed easily.",2020,Both silk and nylon are effective suture materials for autograft suturing in pterygium surgery with similar postoperative discomfort and recurrence rate.,"['50 eyes from 50 patients with primary nasal pterygium', 'Pterygium Surgery']","['conjunctival autograft suturing', 'Silk versus Nylon Sutures', 'pterygium surgery', 'nylon sutures or silk sutures for conjunctival autograft suturing', 'silk versus nylon sutures']","['mean VAS discomfort score', 'number of nylon sutures', 'recurrence, postoperative discomfort according to a visual analog scale (VAS), graft hyperemia, and graft edema', 'recurrence rate of pterygium', 'postoperative discomfort']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0074529', 'cui_str': 'Silk'}, {'cui': 'C0183734', 'cui_str': 'Nylon suture'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0183745', 'cui_str': 'Silk suture'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183734', 'cui_str': 'Nylon suture'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}]",50.0,0.0538521,Both silk and nylon are effective suture materials for autograft suturing in pterygium surgery with similar postoperative discomfort and recurrence rate.,"[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Jamali', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Abuali', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad R', 'Initials': 'MR', 'LastName': 'Khalili', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Middle East African journal of ophthalmology,['10.4103/meajo.MEAJO_166_19']
1972,32841725,"A commentary on ""effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" (Int. J. Surg. 2020; 80:13-18).",,2020,,['elderly patients undergoing hip joint replacement surgery'],['edaravone'],['postoperative cognitive function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Zhao-Jing', 'Initials': 'ZJ', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China. Electronic address: xuefushan@aliyun.com.'}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.020']
1973,32842203,[Clinical efficacy of proton pump inhibitor combined with ranitidine in the treatment of throat reflux].,"Objective: To investigate the clinical effect of proton pump inhibitor combined with ranitidine on patients with laryngopharyngeal reflux.  Method: Seventy patients with laryngopharyngeal reflux diagnosed in our hospital were randomly divided into group A and group B according to admission time. The difference of B symptom index, reflux symptom scale, sleep breathing test, quality of life and well-being score between the two groups were detected.  Result: Before treatment, the RSI index, RFS similarity and QOLS and MUNSH scores were similar （ P >0.05）. After four weeks of treatment, the group B score was 3.3±1.2, the group A score was 8.2±3.5, and the group B score was significantly lower. The RFS score of group A （6.2±2.3） was higher than that of group B （2.1±1.9,  P <0.05）. The scores of QOLS and MUNSH in group B were （67.57±7.26） and （23.99±3.44）, respectively. The scores of QOLS and MUNSH in group A （50.13±10.19） and （12.21±1.47）, respectively. The results of the two groups were significantly different （ P <0.05）. After treatment, the RSI index, RFS score, QOLS and MUNSH scores of the two groups were lower than those before treatment. （ P <0.05）. As for the sleep respiration monitoring （PSG） results, after 4-week treatment, compared with the group A, the total sleep time of the group B was significantly increased （ P <0.05）, and the number of wakefulness and wakefulness was significantly decreased. The duration of Ⅲ+Ⅳ sleep was also significantly increased, and the proportion of REM sleep time and AHI was significantly reduced （ P <0.05）.  Conclusion: Proton pump inhibitor combined with ranitidine is more effective and safer than single drug treatment, and can significantly improve the throat reflux symptoms.",2020,"Before treatment, the RSI index, RFS similarity and QOLS and MUNSH scores were similar （ P >0.05）.","['patients with laryngopharyngeal reflux', 'throat reflux', 'Method: Seventy patients with laryngopharyngeal reflux diagnosed in our hospital']","['ranitidine', 'proton pump inhibitor combined with ranitidine']","['B symptom index, reflux symptom scale, sleep breathing test, quality of life and well-being score', 'proportion of REM sleep time and AHI', 'scores of QOLS and MUNSH', 'throat reflux symptoms', 'RFS score', 'RSI index, RFS score, QOLS and MUNSH scores', 'number of wakefulness and wakefulness', 'RSI index, RFS similarity and QOLS and MUNSH scores', 'duration of Ⅲ+Ⅳ sleep', 'total sleep time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168250', 'cui_str': 'Laryngopharyngeal reflux'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0034665', 'cui_str': 'Ranitidine'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0035127', 'cui_str': 'Repetitive strain injury'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",70.0,0.0210271,"Before treatment, the RSI index, RFS similarity and QOLS and MUNSH scores were similar （ P >0.05）.","[{'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology，Shaoxing Central Hospital，Shaoxing，312030，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.08.008']
1974,32842225,[A comparative study on treatment of severe OSA with UPPP combined with endoscopic low-temperature plasma tongue root resection].,"Objective: The aim of this study is to investigate the effect of modified uvulopalatopharyngoplasty （UPPP） combined with endoscopic hypothermic Plasma glossectomy （Eco-TBR） on the severe Obstructive sleep apnea syndrome.  Method: Sixty patients with severe OSAHS were diagnosed by polysomnography, and their obstructive plane located in the oropharynx and tongue base. Patients were divided into the control group （30 cases of simple H-UPPP） and the experimental group （30 cases of H-UPPP combined with Eco-TBR） according to their random hospital sequence. SPSS 20.0 software package was used to analyze the preoperative and postoperative data of the two groups.  Result: Fifty-seven OSAHS patients had full data and a minimum 6 month follow up to assess the efficacy. The total effective rate in the control group was 41.38% lower than that in the experimental group 67.85%, and the difference was statistically significant （χ²=4.03,  P <0.05）. The postoperative data of the control group, AHI was 28.07±10.283, LSaO2 was 72.660±6.405, ESS was 12.620±2.731, and snoring VAS were 3.93±1.307. After the operation, in the experimental group, AHI was 25.74±14.140, LSaO2 was 75.360±7.299, ESS was 11.320±3.209, and snoring VAS were 3.00±1.305. The differences in AHI, LSaO2, ESS and snoring VAS before and after surgery in the two groups were statistically significant （ P <0.001）. After surgery, compared between the two groups, except for snoring VAS, the differences of AHI, LSaO2 and ESS were not statistically significant（ P >0.05）.  Conclusion: The effect of H-UPPP combined with Eco-TBR on severe OSAHS patients with obstructive plane of oropharynx and tongue root is definite.",2020,"The total effective rate in the control group was 41.38% lower than that in the experimental group 67.85%, and the difference was statistically significant （χ²=4.03,  P <0.05）.","['severe Obstructive sleep apnea syndrome', 'severe OSAHS patients with obstructive plane of oropharynx and tongue root is definite', 'Sixty patients with severe OSAHS were diagnosed by polysomnography, and their obstructive plane located in the oropharynx and tongue base']","['UPPP combined with endoscopic low-temperature plasma tongue root resection', 'H-UPPP combined with Eco-TBR', 'modified uvulopalatopharyngoplasty （UPPP） combined with endoscopic hypothermic Plasma glossectomy （Eco-TBR）', 'control group （30 cases of simple H-UPPP） and the experimental group （30 cases of H-UPPP combined with Eco-TBR']","['AHI, LSaO\ue00c2, ESS and snoring VAS', 'total effective rate', 'snoring VAS', 'LSaO\ue00c2', 'AHI, LSaO\ue00c2 and ESS']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0226956', 'cui_str': 'Structure of pharyngeal portion of dorsum of tongue'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0226958', 'cui_str': 'Structure of root of tongue'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0226956', 'cui_str': 'Structure of pharyngeal portion of dorsum of tongue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2675227', 'cui_str': 'Endocrine-Cerebroosteodysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1535578', 'cui_str': 'Palatopharyngoplasty'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0017673', 'cui_str': 'Glossectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",60.0,0.0217685,"The total effective rate in the control group was 41.38% lower than that in the experimental group 67.85%, and the difference was statistically significant （χ²=4.03,  P <0.05）.","[{'ForeName': 'Yongjin', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Yanting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery，Second Hospital of Shanxi Medical University，Taiyuan，030001，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.04.009']
1975,32842229,[Influence of different methods of silicone tube intubation on clinical effects and safety of patients with chronic dacryocystitis].,"Objective: To investigate the influence of conventional STI and endoscopic STI on clinical effects and safety of patients with chronic dacryocystitis.  Method: One hundred and ten patients with chronic dacryocystitis were chosen in the period in our hospital and randomly divided into two groups including conventional group（55 patients） with conventional STI and endoscopy group（55 patients） with endoscopic STI. The improvement rate of epiphora symptoms, ocular surface symptoms score before and after treatment, operation time, intraoperative VAS score and postoperative complication rate of both groups were compared.  Result: There was no significant difference in the improvement rate of epiphora symptoms between two groups（ P >0.05）. The ocular surface symptoms score after treatment of endoscopy group were significantly less than conventional group（ P <0.05）. There was no significant difference in the ocular surface symptoms score after treatment between two groups（ P >0.05）. The operation time and intraoperative VAS score of endoscopy group were significantly less than conventional group（ P <0.05）. The postoperative complication rate of endoscopy group were significantly lower than conventional group（ P <0.05）.  Conclusion: Conventional STI and endoscopic STI in the treatment of patients with chronic dacryocystitis possess the same clinical effects; but endoscopic STI application can efficiently reduce operation difficulty, relieve intraoperative pain and prevent postoperative complications.",2020,There was no significant difference in the improvement rate of epiphora symptoms between two groups（ P >0.05）.,"['One hundred and ten patients with chronic dacryocystitis', 'patients with chronic dacryocystitis']","['conventional group（55 patients） with conventional STI and endoscopy group（55 patients） with endoscopic STI', 'Conventional STI and endoscopic STI', 'conventional STI and endoscopic STI', 'silicone tube intubation']","['improvement rate of epiphora symptoms', 'postoperative complication rate', 'intraoperative pain', 'operation time, intraoperative VAS score and postoperative complication rate', 'improvement rate of epiphora symptoms, ocular surface symptoms score', 'operation time and intraoperative VAS score', 'ocular surface symptoms score']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149506', 'cui_str': 'Chronic dacryocystitis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}]","[{'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",110.0,0.0185832,There was no significant difference in the improvement rate of epiphora symptoms between two groups（ P >0.05）.,"[{'ForeName': 'Deying', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Otolaryngology，Angang General Hospital，Anyang，455004，China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.04.013']
1976,32844317,Comments on: 'Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'.,,2020,,[],['balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'],[],[],"[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.054021,,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'CORRIB Core Lab and Research Center for Advanced Imaging, National University of Ireland, Galway, Ireland. o.i.soliman@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Leipzig Heart Centre, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Ireland.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01484-0']
1977,32845399,Pain after permanent versus delayed absorbable monofilament suture for vaginal graft attachment during minimally invasive total hysterectomy and sacrocolpopexy.,"OBJECTIVES


The objective was to evaluate pain and dyspareunia in women undergoing minimally invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a light-weight polypropylene mesh 1 year after surgery.
METHODS


This is a planned secondary analysis of a randomized trial comparing permanent (Gore-Tex) versus absorbable suture (PDS) for vaginal attachment of a y-mesh (Upsylon™) during TLH + SCP in women with stage ≥II prolapse. Patient data were collected at baseline and 1 year after surgery. Our primary outcome was patient-reported pain or dyspareunia at 1 year.
RESULTS


Two hundred subjects (Gore-Tex n = 99, PDS n = 101) were randomized and underwent surgery. Overall, the mean age ± SD was 60 ± 10 years, and BMI was 27 ± 5 kg/m 2 . The majority were white (89%), menopausal (77%), and had stage III/IV (63%) prolapse. 93% completed a 1-year follow-up and are included in this analysis (Gor-Tex n = 95, PDS n = 90). The overall rate of participants who reported pain at 1 year was 20%. Of those who did not report any pain at baseline, 23% reported de novo dyspareunia, 4% reported de novo pain, and 3% reported both at 1 year. Of participants who reported pain or dyspareunia at baseline prior to surgery, 66% reported resolution of their symptoms at 1 year. There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year. On multiple logistic regression controlling for age, baseline dyspareunia, and baseline pain, baseline dyspareunia was associated with a nearly 4-fold increased odds of reporting any pain at 1 year (OR 3.8, 95%CI 1.7-8.9).
CONCLUSIONS


The majority of women report resolution of pain 1 year following TLH + SCP with a low rate of de novo pain.",2020,"There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year.","['women with stage ≥II prolapse', 'women undergoing minimally invasive total hysterectomy and', 'Two hundred subjects (Gore-Tex n\u2009=\u200999, PDS n\u2009=\u2009101']","['permanent (Gore-Tex) versus absorbable suture (PDS', 'TLH\u2009+\u2009SCP', 'sacrocolpopexy (TLH\u2009+\u2009SCP) with a light-weight polypropylene mesh', 'delayed absorbable monofilament suture']","['mesh/suture exposure', 'patient-reported pain or dyspareunia', 'de novo dyspareunia', 'baseline dyspareunia, and baseline pain, baseline dyspareunia', 'de novo pain', 'overall rate of participants who reported pain', 'pain and dyspareunia', 'Pain', 'pain or dyspareunia', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0018088', 'cui_str': 'Goretex'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0018088', 'cui_str': 'Goretex'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh'}, {'cui': 'C1961537', 'cui_str': 'Monofilament suture'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",200.0,0.715988,"There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year.","[{'ForeName': 'C Emi', 'Initials': 'CE', 'LastName': 'Bretschneider', 'Affiliation': 'Northwestern Feinstein School of Medicine, 250 E. Superior St. Suite 5-2370, Chicago, IL, 60611, USA. carol.bretschneider@nm.org.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kenton', 'Affiliation': 'Northwestern Feinstein School of Medicine, 250 E. Superior St. Suite 5-2370, Chicago, IL, 60611, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Geller', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wu', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Matthews', 'Affiliation': 'Department of Urology, Wake Forest Baptist Health, Winston Salem, NC, USA.'}]",International urogynecology journal,['10.1007/s00192-020-04471-6']
1978,32846798,The efficacy and safety of intravenous tranexamic acid in anterior cruciate ligament reconstruction: A randomized controlled trial protocol.,"BACKGROUND


The safety and efficacy of intravenous tranexamic acid (TXA) in the anterior cruciate ligament (ACL) reconstruction remains controversial. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the TXA administration, and investigate its clinical applicability. The purpose of this work is to assess the safety and efficacy of the intravenous TXA in decreasing perioperative blood loss in the patients undergoing ACL reconstruction.
METHODS


This randomized, controlled, prospective research was carried out between January 2017 and January 2018. All the patients and their family members signed the informed consent forms, and this current work was authorized via the ethics committee of Nanjing first hospital (registration No.: NJU1003586). A total of 100 patients were divided randomly into 2 group: the control group (n = 50) and study group (n = 50). The study group receives intravenous TXA administration [1 g] before skin incision. The control group receives equivalent normal saline. Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded. The measures of secondary outcomes refer to the clinical data involving the range of motion and postoperative pain score. The pain score was quantified by utilizing the 10-cm scale of visual analog. The pain strength was in the range of 0-10, where 0 is totally no pain and 10 represents the most severe pain.
RESULTS


This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention.
CONCLUSION


Our results can bring a new perspective on the use of TXA after arthroscopically assisted ACL surgery.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5798).",2020,"Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded.","['anterior cruciate ligament (ACL', 'anterior cruciate ligament reconstruction', 'January 2017 and January 2018', 'patients undergoing ACL reconstruction', '100 patients']","['tranexamic acid (TXA', 'tranexamic acid', 'equivalent normal saline', 'TXA', 'intravenous TXA administration [1 g] before skin incision']","['perioperative blood loss', 'efficacy and safety', 'pain strength', 'safety and efficacy', 'clinical data involving the range of motion and postoperative pain score', 'pain score', 'blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0677634', 'cui_str': 'Reptilase time'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",100.0,0.0429763,"Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded.","[{'ForeName': 'Hongyao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of sports and joint, Nanjing Hospital Affiliated to Nanjing Medical University (Nanjing first hospital), Jiangsu, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Xiangjie', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021747']
1979,32846174,Heart rate variability in healthy young adults exposed to global system for mobile communication (GSM) 900-MHz radiofrequency signal from mobile phones.,"Given the large number of mobile phone users and the increasing exposure to radiofrequency electromagnetic field (RF-EMF) worldwide, we aimed to study the effect of RF-EMF related to mobile phones on heart rate variability (HRV). Twenty-six healthy young adults participated in two experimental sessions with a double-blind, randomized and counter-balanced crossover design. During each session, participants were exposed for 26 min to a sham or real 900 MHz RF-EMF, generated by a commercial dual-band Global System for Mobile technology (GSM) mobile phone. We recorded an electrocardiogram at rest during the exposure. We evaluated HRV by time- and frequency-domain analysis. Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure. Other time-domain parameters were not affected. Analysis in the frequency-domain demonstrated that total spectral power and low-frequency band (LF) absolute power were significantly increased during exposure (p = .046 and p = .043, respectively). However, other parameters were not affected. In conclusion, it seems that most HRV parameters were not affected by GSM signal exposure in our study. The weak effect observed on HRV frequency-domain is likely to represent a random occurrence rather than a real effect.",2020,Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure.,"['healthy young adults', 'Twenty-six healthy young adults']","['RF-EMF', 'global system for mobile communication (GSM) 900-MHz radiofrequency signal from mobile phones', 'sham or real 900 MHz RF-EMF, generated by a commercial dual-band Global System for Mobile technology (GSM) mobile phone']","['Heart rate variability', 'heart rate variability (HRV', 'total spectral power and low-frequency band (LF) absolute power', 'standard deviation of interbeat intervals (SDNN']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175723', 'cui_str': 'Band'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",26.0,0.0704992,Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure.,"[{'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Wallace', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.""}, {'ForeName': 'Soafara', 'Initials': 'S', 'LastName': 'Andrianome', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.""}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Ghosn', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.""}, {'ForeName': 'Erwan Stephan', 'Initials': 'ES', 'LastName': 'Blanchard', 'Affiliation': 'PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Telliez', 'Affiliation': 'PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.'}, {'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Selmaoui', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France. Electronic address: brahim.selmaoui@ineris.fr.""}]",Environmental research,['10.1016/j.envres.2020.110097']
1980,32846328,Factors associated with discontinuation in the drug and placebo groups of trials of second generation antipsychotics for acute schizophrenia: A meta-regression analysis: Discontinuation in antipsychotic trials.,"This study investigated factors associated with discontinuation in double-blind, randomized, placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs) for acute schizophrenia, with a view to establishing what factors were associated with all-cause discontinuation. 77 eligible studies (96 comparisons; n = 22,678) were included in this study. Thirty-one factors potentially affecting all-cause discontinuation, related to the participants, study design, and drugs, were included in a meta-regression analysis that examined the factors associated with discontinuation rates in treatment and placebo groups and/or the treatment-placebo group difference in discontinuation. Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group. These factors were also associated with the treatment-placebo group difference in discontinuation. Although the risk of weight gain from SGA use was not associated with discontinuation rates in either the treatment or placebo groups, SGAs with a risk of weight gain were associated with a larger treatment-placebo group difference in discontinuation, although the reason is unknown. Factors associated with discontinuation rates in both treatment and placebo groups did not influence the treatment-placebo group difference in discontinuation. The efficacy and the risk of weight gain of SGAs seemed to influence treatment-placebo group difference in discontinuation in DBRPCTs of SGAs for acute schizophrenia.",2020,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","['acute schizophrenia', '77 eligible studies (96 comparisons; n\xa0=\xa022,678']","['placebo', 'placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs']","['Positive and Negative Syndrome Scale total scores', 'discontinuation rates', 'smaller response rates', 'weight gain']","[{'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",22678.0,0.223392,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan. Electronic address: tarok@fujita-hu.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Okuya', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.08.003']
1981,32846334,Effectiveness of pulmonary rehabilitation at high-altitude compared to sea-level in adults with severe refractory asthma.,"BACKGROUND


Beneficial effects of pulmonary rehabilitation at high-altitude (HAPR) in patients with severe refractory asthma have been reported earlier, but evidence for the effectiveness is limited.
AIM


To investigate the effectiveness of high-altitude pulmonary rehabilitation to comparable treatment at sea-level (LAPR) on patient outcome parameters.
METHODS


Adults with severe refractory asthma living in The Netherlands were included. Treatment consisted of a 12-week personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n = 93) or in a tertiary lung center at sea-level in The Netherlands (n = 45). At baseline, after treatment, and during 12 months follow-up asthma related quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose were assessed. Patients could not be randomized resulting in different asthma populations. Groups were compared using linear regression analysis (ANCOVA) adjusted for baseline values, in addition to age, atopy, smoking history, BMI and gender.
RESULTS


After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear regression analysis-5.29 mg, p = 0.003 and Crude Odds Ratio-1.67, p = 0.003, respectively) were observed in the HAPR-group compared to the LAPR group. Patients receiving HAPR also had less asthma exacerbations (≥1 exacerbation: 20% vs 60%,p < 0.001) and showed improvement in lung function (%predFEV 1  3.4%,p = 0.014) compared to the LAPR group, but at 12 months no differences between groups were observed.
CONCLUSION


HAPR resulted in a larger improvement in patient outcome parameters compared to LAPR, on the long run the improvement in patient reported symptoms and lower maintenance OCS-dose persists. Underlying factors that explain this observed effect need to be investigated.",2020,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","['patients with severe refractory asthma', 'adults with severe refractory asthma', 'Adults with severe refractory asthma living in The Netherlands were included']","['personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n\xa0=\xa093) or in a tertiary lung center at sea-level in The Netherlands', 'pulmonary rehabilitation at high-altitude (HAPR', 'HAPR', 'high-altitude pulmonary rehabilitation', 'pulmonary rehabilitation']","['asthma exacerbations', 'lung function', 'quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.06858,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'de Nijs', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands; Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Krop', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Portengen', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Rijssenbeek-Nouwens', 'Affiliation': 'Dutch Asthma Center Davos, Davos, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Vries', 'Affiliation': 'Merem Asthma Center Heideheuvel, Hilversum, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Weersink', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'H G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands. Electronic address: H.G.M.Heijerman@umcutrecht.nl.'}, {'ForeName': 'D J J', 'Initials': 'DJJ', 'LastName': 'Heederik', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'J W J', 'Initials': 'JWJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106123']
1982,32858145,Dorsolateral Prefrontal Cortex and Task-Switching Performance: Effects of Anodal Transcranial Direct Current Stimulation.,"Task switching refers to the process by which an individual transfers focus from one cognitive task to another. In recent years, transcranial direct current stimulation (tDCS) technology had been used to investigate the causal relationship between the dorsolateral prefrontal cortex (DLPFC) and task-switching performance. However, the effects of anodal-tDCS (a-tDCS) on task switching remain unclear, and the relationship between DLPFC and various task predictabilities have not yet been studied. Therefore, this study mainly investigated the effects of left anode tDCS (LA) and right anode tDCS (RA) in predictable and unpredictable task-switching performance. Thirty-six participants were randomly assigned to three tDCS groups (including LA, RA, and sham) and were asked to complete both the predictable and unpredictable tasks. Compared with LA and sham tDCS, increasing the activity of the right DLPFC improved task-switching performance (switch cost) of unpredictable but not predictable tasks. The results suggested there is a causal association between DLPFC and unpredictable task switching and implied a task-specific effect in task switching. We concluded that the DLPFC is not essential for exogenous adjustment in predictable task switching.",2020,"Compared with LA and sham tDCS, increasing the activity of the right DLPFC improved task-switching performance (switch cost) of unpredictable but not predictable tasks.",['Thirty-six participants'],"['anodal-tDCS (a-tDCS', 'transcranial direct current stimulation (tDCS) technology', 'left anode tDCS (LA) and right anode tDCS (RA', 'LA and sham tDCS', 'Anodal Transcranial Direct Current Stimulation', 'DLPFC']",['activity of the right DLPFC improved task-switching performance (switch cost'],"[{'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",36.0,0.0211483,"Compared with LA and sham tDCS, increasing the activity of the right DLPFC improved task-switching performance (switch cost) of unpredictable but not predictable tasks.","[{'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Rongjuan', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Abaid Ur', 'Initials': 'AU', 'LastName': 'Rehman', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China.""}, {'ForeName': 'Xuqun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': ""Key Laboratory for Behavior and Cognitive Neuroscience of Shaanxi Province, School of Psychology, Shaanxi Normal University, Xi'an 710062, China. Electronic address: youxuqun@snnu.edu.cn.""}]",Neuroscience,['10.1016/j.neuroscience.2020.08.020']
1983,32858210,"A commentary on ""Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" [Int. J. Surg. 80 (2020) 13-18].",,2020,,['Elderly Patients undergoing Hip Joint Replacement Surgery'],['Edaravone'],['Postoperative Cognitive Function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Mingcheng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: ymc19950616@163.com.'}, {'ForeName': 'Zichuan', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zichuanding@163.com.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zongke2017@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.067']
1984,32858227,"The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial.","BACKGROUND AND OBJECTIVES


Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. The objective of this randomized controlled trial (RCT) is to evaluate the efficacy of the Geriatric Emergency Department Innovations (GEDI) program, an ED nurse-led geriatric assessment and care coordination program, in decreasing unnecessary health services use and improving Health-Related Quality-of-Life (HRQoL) for older adults in the ED.
METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420). Outcome variables will be assessed during the ED visit and at 7-11 days and 28-32 days post ED visit.
PROJECTED OUTCOMES


The primary outcome is hospitalization or death within 30 days of the ED visit. Secondary outcomes include health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression].
TRIAL REGISTRATION


Clinicaltrials.Gov identifier NCT04115371.",2020,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","['Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either', 'older adults in the ED', 'Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits']","['Geriatric Emergency Department Innovations (GEDI', 'GEDI (n\u202f=\u202f420) or to usual ED care']","['health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression', 'hospitalization or death within 30\u202fdays of the ED visit', 'infections, delirium, and falls', 'Health-Related Quality-of-Life (HRQoL']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.106207,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Dresden', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: sdresden@nm.org.'}, {'ForeName': 'Alexander X', 'Initials': 'AX', 'LastName': 'Lo', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Lindquist', 'Affiliation': 'Department of Internal Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lori Ann', 'Initials': 'LA', 'LastName': 'Post', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'French', 'Affiliation': 'Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, USA; Department of Veterans Affairs Health Services Research and Development Service, Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University and Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106125']
1985,32859933,Faecal microbiota transplantation for the treatment of diarrhoea induced by tyrosine-kinase inhibitors in patients with metastatic renal cell carcinoma.,"Diarrhoea is one of the most burdensome and common adverse events of chemotherapeutics, and has no standardised therapy to date. Increasing evidence suggests that the gut microbiome can influence the development of chemotherapy-induced diarrhoea. Here we report findings from a randomised clinical trial of faecal microbiota transplantation (FMT) to treat diarrhoea induced by tyrosine kinase inhibitors (TKI) in patients with metastatic renal cell carcinoma (ClinicalTrials.gov number: NCT04040712). The primary outcome is the resolution of diarrhoea four weeks after the end of treatments. Twenty patients are randomised to receive FMT from healthy donors or placebo FMT (vehicle only). Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces. No serious adverse events are observed in both treatment arms. The trial meets pre-specified endpoints. Our findings suggest that the therapeutic manipulation of gut microbiota may become a promising treatment option to manage TKI-dependent diarrhoea.",2020,"Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces.","['patients with metastatic renal cell carcinoma', 'subjects receiving donor faeces', 'Twenty patients']","['FMT', 'tyrosine kinase inhibitors (TKI', 'placebo FMT', 'faecal microbiota transplantation (FMT', 'Faecal microbiota transplantation', 'Donor FMT']","['resolution of diarrhoea', 'Diarrhoea', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.316226,"Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces.","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Ianiro', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Rossi', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Thomas', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Schinzari', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Masucci', 'Affiliation': 'Microbiology Unit, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Quaranta', 'Affiliation': 'Microbiology Unit, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Carlo Romano', 'Initials': 'CR', 'LastName': 'Settanni', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Loris Riccardo', 'Initials': 'LR', 'LastName': 'Lopetuso', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Armanini', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Blanco-Miguez', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Asnicar', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Consolandi', 'Affiliation': 'Institute of Biomedical Technologies (IBT), Italian National Research Council (CNR), Via Fratelli Cervi, 93, 20090, Segrate, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iacovelli', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Sanguinetti', 'Affiliation': 'Microbiology Unit, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Tortora', 'Affiliation': 'Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Segata', 'Affiliation': 'Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Via Sommarive 9, 38123, Povo, Trento, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'Digestive Disease Center, Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy. giovanni.cammarota@unicatt.it.'}]",Nature communications,['10.1038/s41467-020-18127-y']
1986,32860843,Comparison of cardiac function between left bundle branch pacing and right ventricular outflow tract septal pacing in the short-term: A registered controlled clinical trial.,"BACKGROUND


The novel method of left bundle branch pacing (LBBP) has been reported to produce a narrower QRS duration and lower pacing threshold than right ventricular outflow tract septal pacing (RVOP). However, whether LBBP is superior to traditional RVOP in improving cardiac function still lacks sufficient evidence.
OBJECTIVE


The purpose of this study was to compare the changes in cardiac function (especially in brain natriuretic peptide (BNP)levels, left atrial function, and left ventricular diastolic function) within 7 days between LBBP and RVOP.
METHODS AND RESULTS


A single-centre prospective controlled registered clinical study was conducted with 84 patients with bradycardia indications. Forty-two patients underwent RVOP, and 42 patients underwent LBBP. The pacemaker parameters were adjusted so that the ventricular ratio was over 90% and rate was 60-70 bpm. The changes in BNP levels and echocardiogram and speckle-tracking echocardiagraphy findings were compared between the two groups before and within 7 days after implantation: (1) BNP: there was no significant difference in BNP level between the two groups before and 1 day after implantation, while the LBBP group had significantly lower levels than the RVOP group on day 7 [(65.15 ± 56.96)pg/ml vs.(129.82 ± 101.92)pg/ml, P < 0.001]. (2) Cardiac echocardiography: the e' value of the LBBP group was higher than that of the RVOP group 7 days after implantation[(6.39 ± 2.65) cm/s vs. (5.45 ± 1.35)cm/s, P = 0.049]. The E/e' and peak E-wave velocity in the LBBP group decreased significantly after 7 days [16.57 ± 6.55 vs. 12.75 ± 5.16 P = 0.043, (88.6 ± 24.37)cm/s vs. (75.68 ± 28.10)cm/s P = 0.030]; in contrast, there were no significant changes in the RVOP group [14.13 ± 3.85 vs.14.10 ± 4.85 P = 0.50, (77.33 ± 21.14)cm/s vs. (74.45 ± 23.03)cm/s P = 0.56). (3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
CONCLUSION


This study demonstrates that compared to RVOP, LBBP can increase left ventricular early diastolic function, improve BNP levels, and has a tendency to increase left atrial myocardial elasticity and left atrial strain capacity in the short term in pacemaker-dependent patients.",2020,"(3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
",['84 patients with bradycardia indications'],"['left bundle branch pacing (LBBP', 'RVOP', 'RVOP, LBBP', 'LBBP', 'left bundle branch pacing and right ventricular outflow tract septal pacing']","['peak E-wave velocity', 'ventricular ratio', 'BNP level', 'left atrial myocardial elasticity and left atrial strain capacity', 'brain natriuretic peptide (BNP)levels, left atrial function, and left ventricular diastolic function', 'BNP levels and echocardiogram and speckle-tracking echocardiagraphy findings', 'left atrial strain or the strain rate', 'absolute values of left atrial strain and strain rate', 'cardiac function', 'left ventricular early diastolic function, improve BNP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0459156', 'cui_str': 'Left bundle branch structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0225892', 'cui_str': 'Structure of outflow tract of right ventricle'}, {'cui': 'C0442004', 'cui_str': 'Septal'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",84.0,0.0197044,"(3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Bolun', 'Affiliation': ""Xiangya School of Medicine, Central South University, Changsha, People's Republic of China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Pei', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Bofei', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Qiaoli', 'Initials': 'Q', 'LastName': 'Tong', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Hongning', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'You', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ruiqin', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China. Electronic address: 13230178060@163.com.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.08.048']
1987,32860991,Automated MRI assessment confirms cartilage thickness modification in patients with knee osteoarthritis: post-hoc analysis from a phase II sprifermin study.,"BACKGROUND


Sprifermin is under investigation as a potential disease-modifying osteoarthritis drug. Previously, 2-year results from the FORWARD study showed significant dose-dependent modification of cartilage thickness in the total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions, by quantitative magnetic resonance imaging (qMRI) using manual segmentation.
OBJECTIVE


To determine whether qMRI findings from FORWARD could be reproduced by an independent method of automated segmentation using an identical dataset and similar anatomical regions in a post-hoc analysis.
METHOD


Cartilage thickness was assessed at baseline and 6, 12, 18 and 24 months, using automated cartilage segmentation with active appearance models, a supervised machine learning method. Images were blinded for treatment and timepoint. Treatment effect was assessed by observed and adjusted changes using a linear mixed model for repeated measures.
RESULTS


Based on automated segmentation, statistically significant, dose-dependent structural modification of cartilage thickness was observed over 2 years with sprifermin vs placebo for TFTJ (overall treatment effect and dose response, both P < 0.001), MFTC (P = 0.004 and P = 0.044), and LFTC (both P < 0.001) regions. For highest dose, in the central medial tibial (P = 0.008), central lateral tibial (P < 0.001) and central lateral femoral (P < 0.001) regions.
CONCLUSIONS


Cartilage thickness assessed by automated segmentation provided a consistent dose response in structural modification compared with manual segmentation. This is the first time that two independent quantification methods of image analysis have reached the same conclusions in an interventional trial, strengthening the conclusions that sprifermin modifies structural progression in knee osteoarthritis.",2020,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
",['patients with knee osteoarthritis'],"['placebo', 'MRI assessment']","['structural modification of cartilage thickness', 'total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions', 'cartilage thickness', 'central lateral tibial (P<0.001) and central lateral femoral', 'MFTC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0581602', 'cui_str': 'Structural modification'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.166877,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brett', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: Alan.Brett@stryker.com.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: mike.bowes@stryker.com.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK. Electronic address: p.conaghan@leeds.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ladel', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: christoph.ladel@merckgroup.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Guehring', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: hans.guehring@merckgroup.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Moreau', 'Affiliation': 'EMD Serono, Billerica, MA, USA. Electronic address: flavie.moreau@emdserono.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.08.005']
1988,32871881,Effects of adductor canal block on pain management compared with epidural analgesia for patients undergoing total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


Total knee arthroplasty (TKA) is known to be a painful orthopedic procedure and moderate to severe pain is common, especially immediately postoperatively and during active motion. The aim of the present study was to compare epidural analgesia (EA) and adductor canal block (ACB) techniques with regard to early period pain levels, need for additional opioids, and ambulation and functional scores in patients who had undergone primary TKA.
METHODS


Approval for the study was granted by the Changji Branch of the First Affiliated Hospital of Xinjiang Medical University. Written informed consent will be obtained from all of the participants. Inclusion criteria included the following: planned unilateral TKA; spinal anesthesia; American Society of Anesthesiologists physical status classification score of I to III. Prospective assessment will be done for 100 patients who are scheduled for unilateral primary TKA surgery in our academic hospital by a single senior surgeon between August 2020 and December 2021. Patients were randomized to ACB treatment or EA treatment by a computer random number generator. The primary outcome was visual analog scale pain scores in the immediate postoperative period. Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion. Results were evaluated in a confidence interval of 95% and at a significance level of P < .05.
CONCLUSIONS


We hypothesized that standard ACB would be as effective as EA for postoperative pain management following TKA.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5775).",2020,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion.","['Approval for the study was granted by the Changji Branch of the First Affiliated Hospital of Xinjiang Medical University', 'patients who had undergone primary TKA', '100 patients who are scheduled for unilateral primary TKA surgery in our academic hospital by a single senior surgeon between August 2020 and December 2021', 'patients undergoing total knee arthroplasty']","['adductor canal block', 'Total knee arthroplasty (TKA', 'ACB treatment or EA', 'standard ACB', 'epidural analgesia', 'epidural analgesia (EA) and adductor canal block (ACB) techniques']","['visual analog scale pain scores', 'postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion', 'pain management']","[{'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.170627,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion.","[{'ForeName': 'Lianzhou', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Changji Branch of the First Affiliated Hospital of Xinjiang Medical University.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Gynaecology and Obstetrics, Changji First People's Hospital.""}, {'ForeName': 'Zhengkai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Medicine, Changji Branch of the First Affiliated Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Hanjuan', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Changji Branch of the First Affiliated Hospital of Xinjiang Medical University.'}]",Medicine,['10.1097/MD.0000000000021672']
1989,32871992,Effect of comprehensive psychosomatic promotion in hypertension patients with anxiety and depression based on community: A randomized parallel controlled trial.,"BACKGROUND


Mental health is closely related to the occurrence of hypertension, particularly the prognosis of hypertension patients. The role of psychotherapy in the occurrence, development, prevention, and prognosis of hypertension, remains to be clarified.
METHODS/DESIGN


We will conduct a prospective, double-blind, randomized, multiple-centers study. Eighty patients enrolled in this trial will be randomized at 1:1 ratio. The primary endpoint is will be the reduction of the patient psychological scale (PHQ-9) score. Secondary endpoints will be the drop in blood pressure, awareness of physical and mental health and self-efficacy scale. Measurements will be performed at baseline, 5-week (questionnaires only), 10-week (primary endpoint), using the Anxiety Screening Questionnaire (GAD-7) and Depression Scale (PHQ-9). Data analysis will be carried out using the SPSS v.25 software assuming a level of significance of 5%. Results will be analyzed using multilevel, regression analysis and hierarchical linear models.
DISCUSSION


We hope to provide some insight in the understanding the underlying mechanism of the novel mindfulness in the management of hypertension related psychological stress/disturbance, and will enable us to develop novel approach to manage essential hypertension and its related psychological disorders. CLINICAL TRIAL REGISTRY:: http://www.chictr.org.cn (ChiCTR1900028258).",2020,The primary endpoint is will be the reduction of the patient psychological scale (PHQ-9) score.,"['Eighty patients enrolled', 'hypertension patients with anxiety and depression based on community']",['comprehensive psychosomatic promotion'],"['blood pressure, awareness of physical and mental health and self-efficacy scale', 'Anxiety Screening Questionnaire (GAD-7) and Depression Scale (PHQ-9', 'reduction of the patient psychological scale (PHQ-9) score']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.0835284,The primary endpoint is will be the reduction of the patient psychological scale (PHQ-9) score.,"[{'ForeName': 'Hailiang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'aSchool of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine bPsychosomatic and Sleep Medicine, Gansu Gem Flower Hospital cDepartment of Mental Health, Gansu Provincial Centre for Disease Control and Prevention, Lanzhou City, Gansu Province, P.R. China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Da', 'Affiliation': ''}, {'ForeName': 'Runjing', 'Initials': 'R', 'LastName': 'Dai', 'Affiliation': ''}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Jingchun', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021451']
1990,32872000,Examination of pain relief effect of Goreisan for glossodynia.,"BACKGROUND


Pain in glossodynia may be severe; it may prevent patients from working, interfere with daily life activities, and necessitate a patient's visit to a medical institution for consultation and treatment. The pain may be described as persistent and burning (tingling, tingling) or stinging. Patients may complain of dry mouth (dryness), which is thought to cause inflammation of the tongue and gingival mucous membranes and increased pain. Medications are prescribed based on the symptoms of glossodynia, and the therapeutic effect is confirmed. However, each drug has side effects, for example, pain may reduce, but drowsiness and dizziness may occur; further, there is always a tendency of drowsiness.On the other hand, Goreisan, a Chinese herbal medicine, has already been used by physicians to treat pain in the oral and maxillofacial regions resulting from rapid changes in air pressure. However, the lack of high-quality clinical research has been of concern, and a randomized clinical trial to investigate the efficacy and safety of Goreisan for treatment of pain in glossodynia is warranted.
METHODS/DESIGN


This multicenter, randomized, controlled study will involve patients treated for glossodynia-related pain. In the experimental group, Goreisan will be taken for 12 weeks in combination with conventional treatment. Participants in the control group will not take any Kampo medicine; only the standard treatment will be taken. Subsequently, the degree of pain will be assessed, and saliva tests of all the patients on their first visit will be performed. Goreisan will be taken at a dose of 7.5 g/d (minute 3) for 12 consecutive weeks. Twelve weeks later, the degree of pain of each patient will be assessed.
DISCUSSION


The purpose of this study is to investigate the efficacy of Goreisan for pain reduction in patients undergoing treatment for glossodynia-related pain. If pain in glossodynia patients can be reduced by the administration of Goreisan, its candidacy as an alternative treatment for pain in glossodynia can be further supported by more reliable research.
TRIAL REGISTRATION


The study was registered in the jRCTs071200017. URL https://jrct.niph.go.jp/latest-detail/jRCTs071200017.",2020,The purpose of this study is to investigate the efficacy of Goreisan for pain reduction in patients undergoing treatment for glossodynia-related pain.,"['glossodynia patients', 'patients treated for glossodynia-related pain', 'patients undergoing treatment for glossodynia-related pain']",[],"['pain reduction', 'complain of dry mouth (dryness']","[{'cui': 'C0017672', 'cui_str': 'Glossodynia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",,0.0932808,The purpose of this study is to investigate the efficacy of Goreisan for pain reduction in patients undergoing treatment for glossodynia-related pain.,"[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'aDivision of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences bDepartment of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki cAichi Medical University, Nagoya dOrofacial Pain Clinic, Tokyo Medical and Dental University Dental Hospital, Tokyo eNagasaki University Hospital, Clinical Research Center, Nagasaki, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Okayasu', 'Affiliation': ''}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Tachi-Yoshida', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Saisu', 'Affiliation': ''}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Shimada', 'Affiliation': ''}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yamazaki', 'Affiliation': ''}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Imura', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hosogaya', 'Affiliation': ''}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Nakashima', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021536']
1991,32872001,Cytoreductive surgery and HIPEC for malignant ascites from colorectal cancer - a randomized study.,"INTRODUCTION


The efficacy of different timings of cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) in controlling malignant ascites caused by peritoneal carcinomatosis of colorectal cancer (CRC) is not well defined. The study aims to investigate the clinical efficacy and safety of different timings of CRS with HIPEC for malignant ascites caused by peritoneal carcinomatosis from CRC.
MATERIALS AND METHODS


This was a preliminary randomized controlled study performed at the Intracelom Hyperthermic Perfusion Therapy Center of the Cancer Hospital of Guangzhou Medical University (China) from December 2008 to December 2016. The patients were randomized to: CRS, followed by HIPEC (CRS+HIPEC; n = 14), and ultrasound-guided HIPEC, followed by CRS 1 to 2 weeks later (HIPEC+ delayed cytoreductive surgery (dCRS) group, n = 14). The endpoints were complete remission rate of ascites, successful complete CRS rate, and overall survival.
RESULTS


Malignant ascites in all patients showed complete remission; the total effective rate was 100%. Complete CRS was not feasible in any patient. The median follow-up of the 2 groups was 41.9 and 42.3 months in the CRS+HIPEC and HIPEC+dCRS groups, respectively. Overall survival was 14.5 (95%CI: 7-19 months) and 14.3 months (95%CI: 4-21 months) (P > .05). The adverse effects of HIPEC were manageable.
CONCLUSIONS


CRS+HIPEC and HIPEC+dCRS have the same efficacy in controlling malignant ascites caused by CRC and peritoneal carcinomatosis. The timing of CRS and HIPEC does not prolong the survival of patients with peritoneal carcinomatosis from CRC, even when a complete CRS is not feasible.",2020,Overall survival was 14.5 (95%CI: 7-19 months) and 14.3 months (95%CI: 4-21 months) (P > .05).,"['Intracelom Hyperthermic Perfusion Therapy Center of the Cancer Hospital of Guangzhou Medical University (China) from December 2008 to December 2016', 'peritoneal carcinomatosis of colorectal cancer (CRC', 'patients with peritoneal carcinomatosis from CRC']","['CRS+HIPEC and HIPEC+dCRS', 'Cytoreductive surgery and HIPEC', 'CRS, followed by HIPEC (CRS+HIPEC; n\u200a=\u200a14), and ultrasound-guided HIPEC, followed by CRS 1 to 2 weeks later (HIPEC+ delayed cytoreductive surgery (dCRS', 'cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC', 'CRS with HIPEC']","['complete remission; the total effective rate', 'Overall survival', 'Malignant ascites', 'clinical efficacy and safety', 'complete remission rate of ascites, successful complete CRS rate, and overall survival']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0346990', 'cui_str': 'Carcinomatosis of peritoneal cavity'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]",,0.0704196,Overall survival was 14.5 (95%CI: 7-19 months) and 14.3 months (95%CI: 4-21 months) (P > .05).,"[{'ForeName': 'Mingchen', 'Initials': 'M', 'LastName': 'Ba', 'Affiliation': 'aIntracelom Hyperthermic Perfusion Therapy Center, Affiliated Cancer Hospital & Institute of Guangzhou Medical University bDepartment of Pharmacy, Guangzhou Dermatology Institute, Guangzhou, P.R. China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'Yuanfeng', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Yinbin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Kunpeng', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Yinuo', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': ''}, {'ForeName': 'Bohuo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Wanbo', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021546']
1992,32872011,Observation on the clinical effect of thunder-fire moxibustion combined with acupressure on ocular muscle spasm: A clinical randomized controlled trial.,"INTRODUCTION


With the rapid development of social economy, peoples dependence on computers and mobile phones is increasing day by day. This causes people to often overuse. Therefore, the incidence of Ocular muscle spasm has been increasing year by year in recent years. The disease usually starts and hides, which seriously affects the patients social image, daily life, and work.
METHODS/DESIGN


We will compare the clinical efficacy of thunder-fire moxibustion combined with acupressure with pure thunder-fire moxibustion on Ocular muscle spasm using random control method.
DISCUSSION


We aim to find a simple, safe, simple and effective Chinese medicine nursing technology that relieves Ocular muscle spasm.
TRIAL REGISTRATION


ClinicalTrials.gov,ChiCTR2000034187, Registered on 27 June 2020.",2020,"We aim to find a simple, safe, simple and effective Chinese medicine nursing technology that relieves Ocular muscle spasm.
",[],"['thunder-fire moxibustion combined with acupressure', 'thunder-fire moxibustion combined with acupressure with pure thunder-fire moxibustion']","['ocular muscle spasm', 'Ocular muscle spasm']",[],"[{'cui': 'C0450043', 'cui_str': 'Thunder'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}]",,0.0790489,"We aim to find a simple, safe, simple and effective Chinese medicine nursing technology that relieves Ocular muscle spasm.
","[{'ForeName': 'Yi-Fei', 'Initials': 'YF', 'LastName': 'Cao', 'Affiliation': 'aBeijing Hospital of Traditional Chinese Medicine, Capital Medical University bShunyi Hospital of Beijing Hospital of Traditional Chinese Medicine, Beijng, China.'}, {'ForeName': 'Tie-Jun', 'Initials': 'TJ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yong-Mei', 'Initials': 'YM', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Nian', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Peng-Li', 'Initials': 'PL', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Yu-Yan', 'Initials': 'YY', 'LastName': 'Lü', 'Affiliation': ''}, {'ForeName': 'Ying-Xin', 'Initials': 'YX', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Zheng', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021586']
1993,32872012,A randomized controlled trial for gualou danshen granules in the treatment of unstable angina pectoris patients with phlegm-blood stasis syndrome.,"INTRODUCTION


Unstable angina pectoris is an acute exacerbation secondary to coronary artery occlusion. In routine clinical treatment, patients with unstable angina pectoris are prone to recurrence or aggravation of symptoms. Based on the traditional Chinese medicine (TCM) theory, phlegm, and blood stasis are one of the main pathological factors of unstable angina pectoris. The treatment of unstable angina pectoris with phlegm-blood stasis syndrome by Gualou Danshen granules (GLDS) has been the focus of many clinical trials. However, there is no evidence to prove the safety or clinical efficacy of GLDS.
METHODS AND ANALYSIS


In this study, we will conduct a 4-week randomized, controlled feasibility study, with participants recruited from Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine. Sixty subjects are to be diagnosed as having phlegm-blood stasis syndrome and randomly divided into a treatment group (GLDS) and placebo group in a 1:1 ratio. Result measurements will include therapeutic indicators (Clinical Symptom Rating Scale, Phlegm-Blood Stasis Syndrome Scale, and Seattle Angina Questionnaire) and safety indicators (blood routine, urine routine, electrocardiogram, liver function, and kidney function). The clinical data management system (http://www.tcmcec.net/) will be used to collect and manage data. Quality control will be implemented according to good clinical practice.
DISCUSSION


Previous TCM clinical trials have investigated if adding GLDS to standard routine treatment can improve the therapeutic effect in patients with unstable angina pectoris. This study focuses on the safety and efficacy of GLDS on unstable angina pectoris of phlegm-blood stasis type, in order to obtain relevant clinical evidence.
TRIAL REGISTRATION


This study is approved by the Ethics Committee of Guang'anmen Hospital of the China Academy of Chinese Medical Sciences (no. 2019-187-KY-02) and is registered with chictr.org (registration number ChiCTR2000031780).",2020,The treatment of unstable angina pectoris with phlegm-blood stasis syndrome by Gualou Danshen granules (GLDS) has been the focus of many clinical trials.,"['unstable angina pectoris patients with phlegm-blood stasis syndrome', ""participants recruited from Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine"", 'patients with unstable angina pectoris', 'Sixty subjects are to be diagnosed as having phlegm-blood stasis syndrome']","['traditional Chinese medicine (TCM', 'GLDS', 'Gualou Danshen granules (GLDS', 'placebo', 'gualou danshen granules']","['therapeutic effect', 'safety and efficacy', 'therapeutic indicators (Clinical Symptom Rating Scale, Phlegm-Blood Stasis Syndrome Scale, and Seattle Angina Questionnaire) and safety indicators (blood routine, urine routine, electrocardiogram, liver function, and kidney function']","[{'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0023521', 'cui_str': 'Galactosylceramide beta-galactosidase deficiency'}, {'cui': 'C0377336', 'cui_str': 'dan-shen root extract'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005750', 'cui_str': 'Blind loop syndrome'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.037645,The treatment of unstable angina pectoris with phlegm-blood stasis syndrome by Gualou Danshen granules (GLDS) has been the focus of many clinical trials.,"[{'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""aDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China bBeijing University of Chinese Medicine, Beijing 100029, China cHenan University of Chinese Medicine, Henan 450000, China.""}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': ''}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Haoqiang', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Dan', 'Affiliation': ''}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': 'Shangjin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qingyong', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021593']
1994,32871336,Single dose testosterone administration modulates the temporal dynamics of distractor processing.,"Some evidence suggests that testosterone can increase attentional orientation toward biologically relevant stimuli and increase sustained attention during goal-oriented behaviors. While rare irregular distractors often capture attention involuntarily and distract us away from the task at hand, we hypothesized that testosterone might (1) facilitate attentional orientation to novel distractors that are of potential behavioral relevance and (2) inhibit information processing of distractors that are irrelevant to the task. To test this hypothesis, we investigated the effects of testosterone on distractor processing in a novelty oddball task, during which infrequent target and distractor sounds were interspersed within a series of frequent non-target sounds. Using a double-blind, placebo-controlled within-participant design, we administered a single dose of either testosterone or placebo to 34 healthy male volunteers and compared their electroencephalographic responses to distractors. Increased amplitude of the early (260-310 ms) P3 component-which has been associated with phasic arousal and alertness triggered by novel stimuli-was observed in the testosterone session than in the placebo session. This early-P3 response mediated the effect of testosterone administration on target hit rate during the task. In addition, less α-oscillation suppression-which has been associated with the inhibition of task-irrelevant information processing-was observed in response to distractors later (538-757 ms) in the testosterone session than in the placebo session. These results suggest that testosterone facilitated phasic arousal to novel distractors during the early-latency stage, which might have influenced behavioral performance during the task. Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task. Our findings highlight the role of testosterone in distractor processing, and provide a theoretical basis for treating attention-related behavioral disorders with hormone therapies.",2020,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.",['34 healthy male volunteers'],"['placebo', 'testosterone', 'testosterone or placebo']",['temporal dynamics of distractor processing'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",34.0,0.311301,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.","[{'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China; Department of Psychology, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China. Electronic address: ww.peng0923@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104838']
1995,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
1996,32877581,Weight Loss in Underserved Patients - A Cluster-Randomized Trial.,"BACKGROUND


Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking.
METHODS


We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months.
RESULTS


All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events.
CONCLUSIONS


A high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).",2020,"The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001).","['All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic', '803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000', 'primary care clinics in which a high percentage of the patients were from low-income populations']","['high-intensity, lifestyle-based program', 'high-intensity program delivered by health coaches embedded in the clinics', 'standard care from their primary care team', 'intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care']","['weight loss', 'percent change from baseline in body weight', 'Weight Loss', 'percent weight loss', 'serious adverse events']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",803.0,0.0935421,"The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001).","[{'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Katzmarzyk', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Newton', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Eboni G', 'Initials': 'EG', 'LastName': 'Price-Haywood', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Kara D', 'Initials': 'KD', 'LastName': 'Denstel', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Mire', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Tina K', 'Initials': 'TK', 'LastName': 'Thethi', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Brantley', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fonseca', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gugel', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Kathleen B', 'Initials': 'KB', 'LastName': 'Kennedy', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Lavie', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Sarpong', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Springgate', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}]",The New England journal of medicine,['10.1056/NEJMoa2007448']
1997,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES


To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS


Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS


The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1  were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1  were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS


Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
1998,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND


Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES


The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING


Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS


Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION


Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
1999,32877795,Recurrence patterns after neoadjuvant chemoradiotherapy compared with surgery alone in oesophageal squamous cell carcinoma: results from the multicenter phase III trial NEOCRTEC5010.,"BACKGROUND


The aim of this study was to compare recurrence patterns and prognostic factors for developing recurrences in patients with oesophageal squamous cell carcinoma (ESCC) who received neoadjuvant chemoradiotherapy (CRT) followed by surgery or surgery alone from a multicenter phase III trial NEOCRTEC5010.
PATIENTS AND METHODS


Patients with locally advanced ESCC were randomly assigned in a 1:1 ratio to receive neoadjuvant CRT plus surgery (CRT + S group) or surgery alone (S group). CRT consisted of two cycles of vinorelbine and cisplatin with concurrent radiotherapy of 40.0 Gy in 20 fractions. Recurrence patterns, sites, frequency, and timing and potential prognostic factors were compared.
RESULTS


Of the 451 patients enrolled from 2007 to 2014, 411 patients who underwent resection were analysed. After a median follow-up of 51.9 months, 62 patients (33.7%) in the CRT + S group versus 104 patients (45.8%) in the S group experienced recurrences (P = 0.013). The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group. Recurrences occurred earlier in the S group (P = 0.053), and late relapses were much more frequent in the CRT + S group (P = 0.029). On multivariate analysis, R1 resection and surgery alone were adverse factors for developing locoregional recurrences, whereas R1 resection was the only independent factor associated with distant metastases.
CONCLUSIONS


The neoadjuvant CRT regimen was associated with significantly reduced locoregional and distant recurrences compared with surgery alone. Recurrence patterns, sites and frequency were different between groups. TRIAL REGISTRATION CLINICALTRIALS.
GOV IDENTIFIER


NCT01216527.",2020,The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group.,"['patients with oesophageal squamous cell carcinoma (ESCC', '451 patients enrolled from 2007 to 2014, 411 patients who underwent resection were analysed', 'oesophageal squamous cell carcinoma', 'Patients with locally advanced ESCC']","['neoadjuvant chemoradiotherapy', 'vinorelbine and cisplatin with concurrent radiotherapy', 'neoadjuvant chemoradiotherapy (CRT) followed by surgery or surgery alone', 'surgery alone', 'neoadjuvant CRT plus surgery (CRT\xa0+\xa0S group) or surgery alone']","['favourable distant metastasis-free survival', 'locoregional failure-free survival', 'recurrences', 'Recurrences', 'Recurrence patterns, sites, frequency, and timing and potential prognostic factors', 'Recurrence patterns, sites\xa0and frequency', 'Recurrence patterns', 'late relapses', 'locoregional and distant recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0443203', 'cui_str': 'Distant'}]",451.0,0.126553,The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group.,"[{'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Thoracic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiaoqiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Cancer Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Chengchu', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital, Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Thoracic Surgery, Tianjin Medical University Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jiaqing', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mengzhong', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Thoracic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: fujh@sysucc.org.cn.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Xi', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: ximian@sysucc.org.cn.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.002']
2000,32877825,Psychomotor Retardation and the prognosis of antidepressant treatment in patients with unipolar Psychotic Depression.,"BACKGROUND


Psychomotor Retardation is a key symptom of Major Depressive Disorder. According to the literature its presence may affect the prognosis of treatment. Aim of the present study is to investigate the prognostic role of Psychomotor Retardation in patients with unipolar Psychotic Depression who are under antidepressant treatment.
METHODS


The Salpetriere Retardation Rating Scale was administered at baseline and after 6 weeks to 122 patients with unipolar Psychotic Depression who were randomly allocated to treatment with imipramine, venlafaxine or venlafaxine plus quetiapine. We studied the effects of Psychomotor Retardation on both depression and psychosis related outcome measures.
RESULTS


73% of the patients had Psychomotor Retardation at baseline against 35% after six weeks of treatment. The presence of Psychomotor Retardation predicted lower depression remission rates in addition to a higher persistence of delusions. After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
CONCLUSIONS


Our data confirm that Psychomotor Retardation is a severity marker of unipolar Psychotic Depression. It is highly prevalent and predicts lower effectivity of antidepressant psychopharmacological treatment.",2020,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","['patients with unipolar Psychotic Depression', 'patients with unipolar Psychotic Depression who are under antidepressant treatment', '122 patients with unipolar Psychotic Depression']","['imipramine', 'imipramine, venlafaxine or venlafaxine plus quetiapine', 'venlafaxine']","['depression remission rates', 'Salpetriere Retardation Rating Scale', 'Psychomotor Retardation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020934', 'cui_str': 'Imipramine'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}]",122.0,0.0264904,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","[{'ForeName': 'Joost G E', 'Initials': 'JGE', 'LastName': 'Janzing', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands. Electronic address: Joost.Janzing@radboudumc.nl.'}, {'ForeName': 'Tom K', 'Initials': 'TK', 'LastName': 'Birkenhäger', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'van den Broek', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Leonie M T', 'Initials': 'LMT', 'LastName': 'Breteler', 'Affiliation': 'Department of Psychiatry, St. Antonius-Mesos Hospital, Utrecht, the Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Nolen', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.020']
2001,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
2002,32877886,Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial.,"Background OBJECTIVE: To investigate the effects of peripheral muscle training (PMT) and different inspiratory muscle training (IMT) methods on respiratory functions, exercise capacity, and biochemistry parameters in coronary artery disease patients with metabolic syndrome.
METHODS


This prospective, single-blind, randomized-controlled study included 60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA] Class I-II, left ventricular ejection fraction >40%). Patients were randomly divided into three groups: neuromuscular electrical stimulation (NMES) plus PMT group (NMES + PMT group, n = 20), IMT plus PMT group (IMT + PMT group, n = 20) and PMT group (PMT group, n = 20). Treatment continued for six weeks for all groups. The NMES was applied to rectus abdominis, IMT was applied with 30% of maximal inspiratory pressures, and PMT was applied at home. Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters were measured before and after training.
RESULTS


There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05). Significant improvements in C-reactive protein and erythrocyte sedimentation rate were observed in NMES + PMT and IMT + PMT groups (p < 0.05). Among the groups, there was a significant difference in maximal inspiratory pressure (p = 0.02) and erythrocyte sedimentation rate (p = 0.037) in favor of NMES + PMT group (p < 0.05).
CONCLUSION


Our study results showed significant improvements in respiratory functions, exercise capacity, and biochemistry markers in all groups. Different IMT methods can be used in cardiopulmonary rehabilitation to improve exercise intolerance in coronary artery disease patients with metabolic syndrome.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03523026.",2020,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","['coronary artery disease patients with metabolic syndrome', '60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA']","['peripheral muscle training (PMT) and different inspiratory muscle training (IMT', 'peripheral and different inspiratory muscle training methods', 'neuromuscular electrical stimulation (NMES) plus PMT group (NMES\xa0+\xa0PMT group, n\xa0=\xa020), IMT plus PMT group (IMT\xa0+\xa0PMT group, n\xa0=\xa020) and PMT group (PMT', 'NMES']","['Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters', 'exercise intolerance', 'maximal inspiratory pressure', 'respiratory functions, exercise capacity, and biochemistry markers', 'erythrocyte sedimentation rate', 'C-reactive protein and erythrocyte sedimentation rate', 'spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O', 'respiratory functions, exercise capacity, and biochemistry parameters']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}]",60.0,0.028139,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","[{'ForeName': 'Kıymet', 'Initials': 'K', 'LastName': 'Muammer', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Mutluay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Medipol University, Istanbul, Turkey. Electronic address: fmutluay@medipol.edu.tr.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Demir', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Alev Arat', 'Initials': 'AA', 'LastName': 'Özkan', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106119']
2003,32878538,A walking dance to improve gait speed for people with Parkinson disease: a pilot study.,"Aim:  To determine the effectiveness of a targeted dance intervention to improve walking speed for people with Parkinson disease (PD) by increasing motor motivation.  Materials & methods:  11 participants with PD participated in a 6-week pilot study in which they learned a contemporary dance composed of walking steps and designed to mimic everyday walking. 1 h classes occurred twice-weekly.  Results:  Pre- and post-intervention assessments revealed a significant increase in gait speed (t 9  = 3.30; p = 0.009), cadence (t 9  = 2.345; p = 0.044), and stride length (t 9  = 3.757; p = 0.005), and a significant decrease (improvement) in single support time variability (t 9  = -2.744; p = 0.022). There were no significant changes in other measures of gait variability nor in motor symptoms, mood and anxiety, extent of life-space mobility, or quality of life. No adverse events were reported.  Conclusion:  Joywalk provides preliminary evidence that a targeted physical intervention for people with PD may specifically counter bradykinesia.",2020,"There were no significant changes in other measures of gait variability nor in motor symptoms, mood and anxiety, extent of life-space mobility, or quality of life.","[' \xa011\xa0participants with PD participated', 'people with Parkinson disease (PD', 'people with Parkinson disease']","['walking steps and designed to mimic everyday walking', 'targeted dance intervention']","['adverse events', 'gait variability nor in motor symptoms, mood and anxiety, extent of life-space mobility, or quality of life', 'gait speed', 'stride length', 'walking speed']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.034131,"There were no significant changes in other measures of gait variability nor in motor symptoms, mood and anxiety, extent of life-space mobility, or quality of life.","[{'ForeName': 'Elinor C', 'Initials': 'EC', 'LastName': 'Harrison', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO\xa063110, USA.'}, {'ForeName': 'Gammon M', 'Initials': 'GM', 'LastName': 'Earhart', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO\xa063110, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leventhal', 'Affiliation': 'Dance For PD®, Mark Morris Dance Group, Brooklyn, NY\xa011217, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Quinn', 'Affiliation': 'Department of Movement Science & Kinesiology, Teachers College, Columbia University, New York City, NY\xa010027, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Pietro Mazzoni', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO\xa063110, USA.'}]",Neurodegenerative disease management,['10.2217/nmt-2020-0028']
2004,32878708,Efficacy of an intramuscular bivalent norovirus GI.1/GII.4 virus-like particle vaccine candidate in healthy US adults.,"BACKGROUND


We performed this first-in-human efficacy trial of Takeda's bivalent norovirus vaccine candidate (TAK-214) against moderate or severe acute gastroenteritis (AGE) in healthy adults.
METHODS


This double-blind, randomized, placebo-controlled phase 2b trial was conducted over two winter seasons in 18-49 year-old US Navy recruits. Participants were randomized (1:1) to receive intramuscular injections of saline placebo (N = 2,357) or TAK-214 [15 μg GI.1 and 50 μg GII.4c VLPs, 0.5 mg Al(OH) 3 ] (N = 2,355), and monitored for 45 days post-vaccination for AGE. Norovirus genotypes were identified by RT-PCR and sequencing of stool/vomitus samples. Sera from AGE cases were used to assess immune responses as genotype-specific histo-blood group antigen (HBGA)-blocking antibodies.
FINDINGS


With low rates of homotypic norovirus AGE detected the statistical analysis was proactively modified to account for AGE due to any norovirus genotype. Of the 48 norovirus AGE cases of ""any severity"", 29 in placebo and 19 in vaccinees, causative genotypes were GI.1 (n = 1), G1.7a (n = 1), GII.2 (n = 39) and GII.4 (n = 7). Applying predefined definitions of moderate or severe AGE gave 26 vs. 10 cases due to any norovirus genotype in placebo vs. vaccine groups, a vaccine efficacy (VE) of 61.8% (95.01% CI, 20.8 to 81.6; p = 0.0097). Five vs. one moderate or severe cases due to vaccine GI.1/GII.4 homotypic genotypes in placebo vs. vaccine arms gave a primary endpoint vaccine efficacy of 80.0% (99.99% CI, -1318.1 to 99.7; p = 0.142). Levels of GI.1 and GII.4 HBGA-blocking antibodies were increased in vaccinees and in some placebo AGE cases infected with GII.2, indicating cross-reactivity in the immune responses to different genotypes.
INTERPRETATION


Despite limited cases of homotypic norovirus AGE meaning the primary endpoint was not fully evaluable, we showed TAK-214 provided statistically significant efficacy against ""any moderate/severe norovirus AGE"" principally caused by the heterotypic GII.2 genotype, demonstrating induction of cross-genotype protection.",2020,"Levels of GI.1 and GII.4 HBGA-blocking antibodies were increased in vaccinees and in some placebo AGE cases infected with GII.2, indicating cross-reactivity in the immune responses to different genotypes.
","['healthy adults', 'two winter seasons in 18-49\xa0year-old US Navy recruits', 'healthy US adults']","['placebo vs. vaccine', ""Takeda's bivalent norovirus vaccine candidate (TAK-214"", 'intramuscular injections of saline placebo', 'placebo', 'intramuscular bivalent norovirus GI.1/GII.4 virus-like particle vaccine candidate', 'TAK-214']",['Levels of GI.1 and GII.4 HBGA-blocking antibodies'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C2936379', 'cui_str': 'Virus-Like Particle Vaccines'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005804', 'cui_str': 'Blood group antigen'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.387961,"Levels of GI.1 and GII.4 HBGA-blocking antibodies were increased in vaccinees and in some placebo AGE cases infected with GII.2, indicating cross-reactivity in the immune responses to different genotypes.
","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sherwood', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland. Electronic address: Jim.Sherwood@takeda.com.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Mendelman', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lloyd', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'Mengya', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boslego', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Jackson', 'Affiliation': 'Naval Health Research Center, San Diego, CA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Faix', 'Affiliation': 'Naval Health Research Center, San Diego, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.07.069']
2005,32878758,Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy: the PREBOT Pilot  trial.,"INTRODUCTION


Postoperative pancreatic fistula (POPF) is still the most frequently occurring and clinically relevant complication after distal pancreatectomy (DP). Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF. The aim of this project (PREBOT Pilot ) is to generate the first randomised controlled trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX injection into the sphincter of Oddi to prevent clinically relevant POPF following DP.
METHODS AND ANALYSIS


PREBOT Pilot  is an investigator-initiated, single-centre, randomised, controlled, open-label, phase II clinical trial with two parallel study groups and an exploratory study design. 60 patients scheduled for DP will be randomised to intervention and control group. In the intervention group, patients will undergo preoperative endoscopic injection of BTX into the sphincter of Oddi, whereas in the control group no preoperative endoscopy will be performed. The combined primary endpoint is the occurrence of clinically relevant POPF and/or death within 30 days after DP. The secondary endpoints comprise further postoperative outcome parameters and quality of life up to 3 months after DP as well as safety and feasibility of the procedure. Statistical analysis is based on the modified intention-to-treat population, excluding patients without status post DP. For safety analysis, rates of adverse events (AEs) and serious AEs will be calculated with 95% CIs for group comparisons.
ETHICS, FUNDING AND DISSEMINATION


PREBOT Pilot  has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4043654) and the Ethics Committee of Heidelberg University (reference number AFmo-523/2019). This trial is supported by the German Federal Ministry of Education and Research (BMBF). The results of the trial will be presented at national and international conferences and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


DRKS00020401.",2020,Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF.,"['postoperative pancreatic fistula after distal pancreatectomy', '60 patients scheduled for DP']","['preoperative endoscopic BTX injection', 'BOTulinum toxin', 'botulinum toxin (BTX']","['postoperative outcome parameters and quality of life up to 3 months after DP as well as safety and feasibility of the procedure', 'rates of adverse events (AEs) and serious AEs', 'occurrence of clinically relevant POPF and/or death']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",60.0,0.192462,Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Klaiber', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sauer', 'Affiliation': 'Interdisciplinary Centre of Endoscopy, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Eike', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Patient Advocacy, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Luntz', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Probst', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Buchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, Germany thilo_hackert@med.uni-heidelberg.de.'}]",BMJ open,['10.1136/bmjopen-2020-036815']
2006,32878759,Understanding the mechanisms of a combined physical and psychological intervention for people with neurogenic claudication: protocol for a causal mediation analysis of the BOOST trial.,"INTRODUCTION


Conservative treatments such as exercise are recommended for the management of people with neurogenic claudication from spinal stenosis. However, the effectiveness and mechanisms of effect are unknown. This protocol outlines an a priori plan for a secondary analysis of a multicentre randomised controlled trial of a physiotherapist-delivered, combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme).
METHODS AND ANALYSES


We will use causal mediation analysis to estimate the mechanistic effects of the BOOST programme on the primary outcome of disability (measured by the Oswestry Disability Index). The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity. All mediators will be measured at 6 months and the outcome will be measured at 12 months from randomisation. Patient characteristics and possible confounders of the mediator-outcome effect will be measured at baseline. Sensitivity analyses will be conducted to evaluate the robustness of the estimated effects to varying levels of residual confounding.
ETHICS AND DISSEMINATION


Ethical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). The results of this analysis will be disseminated in peer-reviewed journals and at relevant scientific conferences.
TRIAL REGISTRATION NUMBER


ISRCTN12698674.",2020,"The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity.","['people with neurogenic claudication from spinal stenosis', 'people with neurogenic claudication', 'Older people with Spinal Trouble (BOOST) programme']","['combined physical and psychological intervention', 'physiotherapist-delivered, combined physical and psychological intervention']","['fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580173', 'cui_str': 'Neurogenic claudication'}, {'cui': 'C0037944', 'cui_str': 'Spinal stenosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.197664,"The primary mechanism of interest is walking capacity, and secondary mediators include fear-avoidance behaviour, walking self-efficacy, physical function, physical activity and/or symptom severity.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Comer', 'Affiliation': 'Musculoskeletal and Rehabilitation Services, Leeds Community Healthcare NHS Trust, Leeds, UK c.comer@leeds.ac.uk.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, New South Wales, Australia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'The Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lamb', 'Affiliation': 'The Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, Oxfordshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037121']
2007,32878764,"Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit.","INTRODUCTION


Automated systems for ventilator management to date have been either fully heuristic rule-based systems or based on a combination of simple physiological models and rules. These have been shown to reduce the duration of mechanical ventilation in simple to wean patients. At present, there are no published studies that evaluate the effect of systems that use detailed physiological descriptions of the individual patient.The BEACON Caresystem is a model-based decision support system that uses mathematical models of patients' physiology in combination with models of clinical preferences to provide advice on appropriate ventilator settings. An individual physiological description may be particularly advantageous in selecting the appropriate therapy for a complex, heterogeneous, intensive care unit (ICU) patient population.
METHODS AND ANALYSIS


Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting. The trial will enrol 274 participants across multiple London National Health Service ICUs. The trial will use a primary outcome of duration of mechanical ventilation until successful extubation.
ETHICS AND DISSEMINATION


Safety oversight will be under the direction of an independent committee of the study sponsor. Study approval was obtained from the regional ethics committee of the Health Research Authority (HRA), (Research Ethic Committee (REC) reference: 17/LO/0887. Integrated Research Application System (IRAS) reference: 226610. Results will be disseminated through international critical care conference/symposium and publication in peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov under NCT03249623. This research is registered with the National Institute for Health Research under CPMS ID: 34831.",2020,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.",['274 participants across multiple London National Health Service ICUs'],"['Intensive Care Weaning (iCareWean) protocol', 'Intenive Care weaning (iCareWean']",[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.189947,"Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting.","[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Vizcaychipi', 'Affiliation': 'APMIC, Imperial College London, London, UK m.vizcaychipi@imperial.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martins', 'Affiliation': 'Research Trial Unit, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'White', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Dan Stleper', 'Initials': 'DS', 'LastName': 'Karbing', 'Affiliation': 'Center for Model-based Medical Decision Support, Aalborg Universitet, Aalborg, Denmark.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Anaesthetic Department, West Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Suveer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Magill Department of Anaesthesia and Intensive Care Medicine, Chelsea and Westminster Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Osman', 'Affiliation': 'Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS Foundation Trust, London, London, UK.'}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Moreno-Cuesta', 'Affiliation': 'Anaesthetic Department, North Middlesex University Hospital NHS Trust, London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rees', 'Affiliation': 'Department of Health Science and Technology, Aalborg Universitet Institut for Medicin og Sundhedsteknologi, Aalborg, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-042145']
2008,32878820,Randomized Study of Postoperative Single Intravesical Instillation With Pirarubicin and Mitomycin C for Low-risk Bladder Cancer.,"BACKGROUND


To assess the prophylactic efficacy of postoperative single intravesical instillation with pirarubicin (THP) and mitomycin C (MMC) for low-risk non-muscle-invasive bladder cancer (NMBC).
PATIENTS AND METHODS


A total of 103 clinically low-risk NMBC patients were preoperatively randomized into either THP (n=49) or MMC (n=54) groups. The primary endpoint was recurrence-free survival.
RESULTS


The median follow-up periods of the THP and MMC groups were 955 and 1008 days, respectively (p=0.76). Twelve patients (24.5%) in the THP group and 7 (13%) in the MMC group had bladder cancer recurrences. The two-year recurrence-free survival of the THP group and the MMC group was 77.8% and 86.4%, respectively (p=0.20). Neither groups had severe toxicity.
CONCLUSION


In low-risk NMBC, the prophylactic effect against postoperative single intravesical instillation with THP was not superior to that with MMC.",2020,"The two-year recurrence-free survival of the THP group and the MMC group was 77.8% and 86.4%, respectively (p=0.20).","['low-risk non-muscle-invasive bladder cancer (NMBC', '103 clinically low-risk NMBC patients', 'Low-risk Bladder Cancer']","['Postoperative Single Intravesical Instillation With Pirarubicin and Mitomycin C', 'THP', 'MMC', 'pirarubicin (THP) and mitomycin C (MMC']","['recurrence-free survival', 'severe toxicity', 'bladder cancer recurrences']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0071126', 'cui_str': 'Pirarubicin'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",103.0,0.103841,"The two-year recurrence-free survival of the THP group and the MMC group was 77.8% and 86.4%, respectively (p=0.20).","[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan shinya.yamamoto@jfcr.or.jp.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Kageyama', 'Affiliation': 'Department of Urology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Aizawa', 'Affiliation': 'Department of Urology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Urakami', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Iwao', 'Initials': 'I', 'LastName': 'Fukui', 'Affiliation': 'Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}]",Anticancer research,['10.21873/anticanres.14535']
2009,32878899,"Cost-effectiveness analysis of tranexamic acid for the treatment of traumatic brain injury, based on the results of the CRASH-3 randomised trial: a decision modelling approach.","INTRODUCTION


An estimated 69 million traumatic brain injuries (TBI) occur each year worldwide, with most in low-income and middle-income countries. The CRASH-3 randomised trial found that intravenous administration of tranexamic acid within 3 hours of injury reduces head injury deaths in patients sustaining a mild or moderate TBI. We examined the cost-effectiveness of tranexamic acid treatment for TBI.
METHODS


A Markov decision model was developed to assess the cost-effectiveness of treatment with and without tranexamic acid, in addition to current practice. We modelled the decision in the UK and Pakistan from a health service perspective, over a lifetime time horizon. We used data from the CRASH-3 trial for the risk of death during the trial period (28 days) and patient quality of life, and data from the literature to estimate costs and long-term outcomes post-TBI. We present outcomes as quality-adjusted life years (QALYs) and 2018 costs in pounds for the UK, and US dollars for Pakistan. Incremental cost-effectiveness ratios (ICER) per QALY gained were estimated, and compared with country specific cost-effective thresholds. Deterministic and probabilistic sensitivity analyses were also performed.
RESULTS


Tranexamic acid was highly cost-effective for patients with mild TBI and intracranial bleeding or patients with moderate TBI, at £4288 per QALY in the UK, and US$24 per QALY in Pakistan. Tranexamic acid was 99% and 98% cost-effective at the cost-effectiveness thresholds for the UK and Pakistan, respectively, and remained cost-effective across all deterministic sensitivity analyses. Tranexamic acid was even more cost-effective with earlier treatment administration. The cost-effectiveness for those with severe TBI was uncertain.
CONCLUSION


Early administration of tranexamic acid is highly cost-effective for patients with mild or moderate TBI in the UK and Pakistan, relative to the cost-effectiveness thresholds used. The estimated ICERs suggest treatment is likely to be cost-effective across all income settings globally.",2020,"RESULTS


Tranexamic acid was highly cost-effective for patients with mild TBI and intracranial bleeding or patients with moderate TBI, at £4288 per QALY in the UK, and US$24 per QALY in Pakistan.","['patients sustaining a mild or moderate TBI', 'patients with mild or moderate TBI in the UK and Pakistan', 'traumatic brain injury']","['tranexamic acid', 'Tranexamic acid']","['cost-effectiveness', 'quality-adjusted life years (QALYs) and 2018 costs in pounds for the UK, and US dollars for Pakistan', 'cost-effective', 'head injury deaths', 'Incremental cost-effectiveness ratios (ICER) per QALY']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0979185,"RESULTS


Tranexamic acid was highly cost-effective for patients with mild TBI and intracranial bleeding or patients with moderate TBI, at £4288 per QALY in the UK, and US$24 per QALY in Pakistan.","[{'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK Jack.Williams@lshtm.ac.uk.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Lecky', 'Affiliation': 'Centre for Urgent and Emergency Care Research, School of Health and Related Research, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rizwana', 'Initials': 'R', 'LastName': 'Chaudhri', 'Affiliation': 'Holy Family Hospital, Rawalpindi Medical University, Rawalpindi, Pakistan.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Miners', 'Affiliation': 'Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}]",BMJ global health,['10.1136/bmjgh-2020-002716']
2010,32846806,"Efficacy of nasal high flow therapy on the coordination between breathing and swallowing of saliva during daytime nap in chronic obstructive pulmonary disease patients: A single center, randomized crossover controlled study.","BACKGROUND


There are some clinical reports on dysphagia in patients with chronic obstructive pulmonary disease (COPD); however, its pathophysiology remains largely unknown.Changes in respiratory function occur in patients with COPD causing a decrease in tidal volume and an increase in respiratory rate (tachypnea). In addition, it leads to lack of coordination between respiration and swallowing.A new treatment called nasal high flow (NHF) has been introduced for patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure. The NHF therapy involves inhalation of high flow of humidified air, which reduces respiratory effort in patients with COPD. Furthermore, NHF therapy facilitates swallowing of saliva even during respiratory management. A recent clinical study reported that high-flow nasal cannula oxygen therapy for 6 weeks improved the health-related quality of life and reduced hypercapnia in patients with stable COPD. Taken together, NHF therapy is gaining attention in the clinical management of patients with COPD.Therefore, in this study, we aim to examine the efficacy of NHF therapy on the coordination between breathing and swallowing of saliva during daytime nap in patients with COPD.
METHODS/DESIGN


This open-label, investigator-initiated, single center study will evaluate the efficacy of NHF therapy on the coordination between breathing and swallowing of saliva during the daytime nap in COPD patients with forced expiratory volume in 1 second (FEV1%) of <70% during treatment at the Nagasaki University Hospital Respiratory Rehabilitation Center. Evaluations will be performed during the 90 to 180 minute ""daytime nap"" in the measurement room of the hospital. The primary endpoint will be the rate of appearance of the expiratory phase after swallowing of saliva and the frequency of swallowing during the measurement period.
DISCUSSION


The purpose of this study is to obtain evidence regarding the utility of NHF as a potential therapeutic device for COPD patients to prevent aspiration of saliva during the sleep stage of daytime nap. The utility will be assessed by comparing the decrease in incidence rates of the expiratory phase after swallowing of saliva in the NHF device group and the control group, wherein this device was not used.",2020,"A new treatment called nasal high flow (NHF) has been introduced for patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure.","['patients with chronic obstructive pulmonary disease (COPD', 'COPD patients with forced expiratory volume in 1\u200asecond (FEV1%) of <70% during treatment at the Nagasaki University Hospital Respiratory Rehabilitation Center', 'patients with COPD', 'patients with stable COPD', 'COPD patients to prevent aspiration of saliva during the sleep stage of daytime nap', 'chronic obstructive pulmonary disease patients', 'patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure']","['nasal high flow therapy', 'NHF therapy', 'NHF']","['coordination between breathing and swallowing of saliva', 'respiratory rate (tachypnea', 'rate of appearance of the expiratory phase after swallowing of saliva and the frequency of swallowing during the measurement period', 'tidal volume', 'health-related quality of life and reduced hypercapnia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0429933', 'cui_str': 'Measurement period'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]",,0.0371154,"A new treatment called nasal high flow (NHF) has been introduced for patients with COPD, replacing the traditional non-invasive ventilation (NIV) procedure.","[{'ForeName': 'Terumi', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Hisamatsu', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tamada', 'Affiliation': 'Department of Special Care Dentistry.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher & Paykel Healthcare Ltd., Auckland, New Zealand.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher & Paykel Healthcare Ltd., Auckland, New Zealand.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Takahata', 'Affiliation': 'Department of Rehabilitation Medicine, Nagasaki University Hospital.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Special Care Dentistry.'}]",Medicine,['10.1097/MD.0000000000021778']
2011,32847776,Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial.,"OBJECTIVE


Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined.
DESIGN


A parallel, randomized, placebo-controlled trial.
SETTING


Tertiary level oncology center.
PATIENTS


88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited.
INTERVENTION


Participants were randomly allocated into 4 equal groups received 2 h preoperatively, placebo (D0, N = 22), Duloxetine 30 mg (D30, N = 22), Duloxetine 60 mg (D60, N = 22) and Duloxetine 90 mg (D90, N = 22) tablet.
MEASUREMENTS


The primary outcome; 24 h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting) were measured.
RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
CONCLUSION


Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects.
TRIAL REGISTRATION


The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348.",2020,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","['88 female patients with breast cancer', 'patients undergoing modified radical mastectomy', 'Tertiary level oncology center']","['Duloxetine', 'modified radical mastectomy (MRM) with ASA class', '2\xa0h preoperatively, placebo', 'Duloxetine 30\xa0mg (D30, N\xa0=\xa022), Duloxetine 60\xa0mg (D60, N\xa0=\xa022) and Duloxetine 90\xa0mg (D90, N\xa0=\xa022) tablet', 'placebo', 'morphine', 'Preoperative Duloxetine']","['level of sedation', 'analgesic efficacy and side effects', '24\xa0h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting', 'vomiting', 'median (IQR) consumption', 'acute pain and quality of recovery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1616501', 'cui_str': 'duloxetine 30 MG [Cymbalta]'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",88.0,0.273346,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Nourhan Alaa', 'Initials': 'NA', 'LastName': 'Elgalaly', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Helal F', 'Initials': 'HF', 'LastName': 'Hetta', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Department of Medical Microbiology and Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: Helal.hetta@uc.edu.'}, {'ForeName': 'Montaser A', 'Initials': 'MA', 'LastName': 'Fattah Mohammad', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110007']
2012,32845740,Safety and efficacy of galcanezumab in Taiwanese patients: a post-hoc analysis of phase 3 studies in episodic and chronic migraine.,"OBJECTIVE


Migraine is a chronic, disabling neurological disease affecting >1 billion people worldwide. Migraine remains undertreated in Asia, including Taiwan. Galcanezumab is a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide, a peptide firmly established in the pathophysiology of migraine, with demonstrated efficacy and safety in patients with episodic or chronic migraine. Our objective was to evaluate the efficacy and safety of galcanezumab in Taiwanese patients with episodic or chronic migraine.
METHODS


We conducted a sub-group analysis of the Taiwanese cohort from two double-blind, placebo-controlled, Phase 3 clinical trials of galcanezumab in the prevention of episodic and chronic migraine, EVOLVE-2 (NCT02614196) and REGAIN (NCT02614261), respectively. During the EVOLVE-2 and REGAIN double-blind periods, 2092 patients were randomly assigned to receive monthly injections of either placebo, 120 mg galcanezumab (240 mg loading dose), or 240 mg galcanezumab. In REGAIN, a 9-month open-label period followed. Post-hoc analysis on the Taiwanese population across both trials included 106 patients, 45 of whom continued into the open-label period in REGAIN.
RESULTS


Our findings show that galcanezumab has similar efficacy and safety in the Taiwanese population, as compared to the ""All Patients"" population included in the study. Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with  a  ≥ 50% response, and positively impacted quality of life.
CONCLUSION


Galcanezumab is a promising therapeutic for the preventive treatment of migraine in the Taiwanese population.",2020,"Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with a ≥50% response, and positively impacted quality of life.","['Taiwanese Patients', '2092 patients', '106 patients, 45 of whom continued into the open-label period in REGAIN', 'Taiwanese patients with episodic or chronic migraine', 'patients with episodic or chronic migraine', 'Migraine remains undertreated in Asia, including Taiwan']","['galcanezumab', 'placebo', 'Galcanezumab']","['Safety and efficacy', 'efficacy and safety', 'quality of life', 'number of monthly migraine headache days']","[{'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",2092.0,0.145128,"Galcanezumab treatment reduced the number of monthly migraine headache days, determined a higher percentage of patients with a ≥50% response, and positively impacted quality of life.","[{'ForeName': 'Chun-Pai', 'Initials': 'CP', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Kuang Tien General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chia-Fang', 'Initials': 'CF', 'LastName': 'Lee', 'Affiliation': 'Eli Lilly and Company, Taipei, Taiwan.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': ""Dell'Agnello"", 'Affiliation': 'Eli Lilly and Company, Sesto Fiorentino, Italy.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hundemer', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Neurological Institute, Taipei-Veterans General Hospital, Taipei, Taiwan.'}]",Current medical research and opinion,['10.1080/03007995.2020.1815181']
2013,32853271,A clinical algorithm for same-day HIV treatment initiation in settings with high TB symptom prevalence in South Africa: The SLATE II individually randomized clinical trial.,"BACKGROUND


Many countries encourage same-day initiation of antiretroviral therapy (ART), but evidence on eligibility for same-day initiation, how best to implement it, and its impact on outcomes remains scarce. Building on the Simplified Algorithm for Treatment Eligibility (SLATE) I trial, in which nearly half of participants were ineligible for same-day initiation mainly because of TB symptoms, the study evaluated the revised SLATE II algorithm, which allowed same-day initiation for patients with mild TB symptoms and other less serious reasons for delay.
METHODS AND FINDINGS


SLATE II was a nonblinded, 1:1 individually randomized pragmatic trial at three primary healthcare clinics in Johannesburg, South Africa. It randomized adult patients presenting for an HIV test or any HIV care but not yet on ART. Intervention arm patients were assessed with a symptom screen, medical history, brief physical examination, and readiness questionnaire to distinguish between patients eligible for immediate ART dispensing and those requiring further care before initiation. Standard arm patients received usual care. Follow-up was by review of routine clinic records. Primary outcomes were (1) ART initiation in ≤7 days and (2) ART initiation in ≤28 days and retention in care at 8 months (composite outcome). From 14 March to 18 September 2018, 593 adult HIV+, nonpregnant patients were enrolled (median interquartile range [IQR] age 35 [29-43]; 63% (n = 373) female; median CD4 count 293 [133-487]). Half of study patients (n = 295) presented with TB symptoms, whereas only 13 (4%) standard arm and 7 (2%) intervention arm patients tested positive for TB disease. Among 140 intervention arm patients with TB symptoms, 72% were eligible for same-day initiation. Initiation was higher in the intervention (n = 296) versus standard arm (n = 297) by 7 days (91% versus 68%; risk difference [RD] 23% [95% confidence interval (CI) 17%-29%]) and 28 days (94% versus 82%; RD 12% [7%-17%]) after enrollment. In total, 87% of intervention and 38% of standard arm patients initiated on the same day. By 8 months after study enrollment, 74% (220/296) of intervention and 59% (175/297) of standard arm patients had both initiated ART in ≤28 days and been retained in care (RD 15% [7%-23%]). Among the 41% of participants with viral load results available, suppression was 90% in the standard arm and 92% in the intervention arm among patients initiated in ≤28 days. No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up. Limitations of the study included limited geographic generalizability, exclusion of patients too sick to consent, fluctuations in procedures in the standard arm over the course of the study, high fidelity to the trial protocol by study staff, and the possibility of overestimating loss to follow-up due to data constraints.
CONCLUSIONS


More than 85% of patients presenting for HIV testing or care, including those newly diagnosed, were eligible and ready for same-day initiation under the SLATE II algorithm. The algorithm increased initiation within 7 days without appearing to compromise retention and viral suppression at 8 months, offering a practical and acceptable approach that can be widely and immediately utilized by existing providers.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018.",2020,No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up.,"['140 intervention arm patients with TB symptoms, 72% were eligible for same-day initiation', 'adult patients presenting for an HIV test or any HIV care but not yet on ART', 'From 14 March to 18 September 2018, 593 adult HIV+, nonpregnant patients were enrolled (median interquartile range [IQR] age 35 [29-43]; 63% (n = 373) female; median CD4 count 293 [133-487', 'Intervention arm patients were assessed with a symptom screen, medical history, brief physical examination, and readiness questionnaire to distinguish between patients eligible for immediate ART dispensing and those requiring further care before initiation', 'settings with high TB symptom prevalence in South Africa', 'SLATE II was a nonblinded, 1:1 individually randomized pragmatic trial at three primary healthcare clinics in Johannesburg, South Africa']",['usual care'],"['ART initiation in ≤7 days and (2) ART initiation in ≤28 days and retention in care', 'adverse events', 'Initiation', 'TB symptoms']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",3.0,0.352693,No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up.,"[{'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Maskew', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alana T', 'Initials': 'AT', 'LastName': 'Brennan', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lungisile', 'Initials': 'L', 'LastName': 'Vezi', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003226']
2014,32853647,Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone.,"BACKGROUND


Long-term testosterone replacement therapy (TRT) increases muscle mass in elderly men with subnormal testosterone levels. However, the molecular mechanisms underlying this effect of TRT on protein balance in human skeletal muscle in vivo remain to be established.
METHODS


Here, we examined skeletal muscle biopsies obtained before and 24-h after the last dose of treatment with either testosterone gel (n = 12) or placebo (n = 13) for 6 months in aging men with subnormal bioavailable testosterone levels. The placebo-controlled, testosterone-induced changes (β-coefficients) in mRNA levels, protein expression and phosphorylation were examined by quantitative real-time PCR and western blotting.
RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors. However, TRT caused a sustained decrease in protein expression of SMAD2 (β = -36%, p = 0.004) and SMAD3 (β = -32%, p = 0.001), which was accompanied by reduced protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1 (β = -26%, p = 0.004) and Atrogin-1/MAFbx (β = -20%, p = 0.04), but with no changes in FOXO3 signalling. Importantly, TRT did not affect muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres.
CONCLUSIONS


Our results indicate that long-term TRT of elderly men with subnormal testosterone levels increases muscle mass, at least in part, by decreasing protein breakdown through the ubiquitin proteasome pathway mediated by a sustained suppression of SMAD-signalling and muscle-specific E3-ubiquitin ligases.",2020,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","['aging men with subnormal testosterone', 'elderly men with subnormal testosterone levels']","['testosterone replacement therapy (TRT', 'long-term testosterone therapy', 'placebo', 'testosterone gel', 'TRT']","['muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres', 'protein expression of SMAD2', 'Atrogin-1/MAFbx', 'muscle mass', 'skeletal muscle mass and fibre-type distribution', 'protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1', 'mRNA levels, protein expression and phosphorylation', 'mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1566790', 'cui_str': 'SMAD2 protein, human'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041538', 'cui_str': 'Ubiquitin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0076925', 'cui_str': 'USF Transcription Factors'}]",,0.0809258,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","[{'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Kruse', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Stine J', 'Initials': 'SJ', 'LastName': 'Petersson', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark; Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'Rugivan', 'Initials': 'R', 'LastName': 'Sabaratnam', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, DK-5230 Odense, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Højlund', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark. Electronic address: kurt.hoejlund@rsyd.dk.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154347']
2015,32853672,Safety and effectiveness of azithromycin in patients with COVID-19: An open-label randomised trial.,"As no specific pharmacological treatment has been validated for use in coronavirus disease 2019 (COVID-19), we aimed to assess the effectiveness of azithromycin (AZM) in these patients at a referral centre in Iran. An open-label, randomised controlled trial was conducted on patients with laboratory-confirmed COVID-19. A total of 55 patients in the control group receiving hydroxychloroquine (HCQ) and lopinavir/ritonavir (LPV/r) were compared with 56 patients in the case group who in addition to the same regimen also received AZM. Patients with prior cardiac disease were excluded from the study. Furthermore, patients from the case group were assessed for cardiac arrythmia risk based on the American College of Cardiology (ACC) risk assessment for use of AZM and HCQ. The main outcome measures were vital signs, SpO 2  levels, duration of hospitalisation, need for and length of intensive care unit admission, mortality rate and results of 30-day follow-up after discharge. Initially, there was no significant difference between the general conditions and vital signs of the two groups. The SpO 2  levels at discharge were significantly higher, the respiratory rate was lower and the duration of admission was shorter in the case group. There was no significant difference in the mortality rate between the two groups. Patients who received AZM in addition to HCQ and LPV/r had a better general condition. HCQ+AZM combination may be beneficial for individuals who are known to have a very low underlying risk for cardiac arrhythmia based on the ACC criteria.",2020,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","['patients at a referral center in Iran', 'Patients with COVID-19', 'Patients with prior cardiac disease', 'patients with laboratory confirmed COVID-19']","['hydroxychloroquine', 'azithromycin and hydroxychloroquine', 'azithromycin', 'hydroxychloroquine-azithromycin', 'hydroxychloroquine and lopinavir / ritonavir', 'Azithromycin']","['respiratory rate', 'duration of admission', 'mortality rate', 'SpO2 levels at discharge', 'cardiac arrythmia risk', 'vital signs, SpO2 levels, duration of hospitalization, need for and length of intensive care unit (ICU) admission, mortality rates, and results of 30-day follow-up after discharge', 'general conditions and vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0611014,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Sekhavati', 'Affiliation': 'Department of Cardiology, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran; Iran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: fatemejafari72@gmail.com.'}, {'ForeName': 'SeyedAhmad', 'Initials': 'S', 'LastName': 'SeyedAlinaghi', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeidreza', 'Initials': 'S', 'LastName': 'Jamalimoghadamsiahkali', 'Affiliation': 'Department of Infectious Diseases, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sadr', 'Affiliation': 'Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabarestani', 'Affiliation': 'Medical Students Research Committee, Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pirhayati', 'Affiliation': 'Iran University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Zendehdel', 'Affiliation': 'Geriatric Department, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Manafi', 'Affiliation': 'Iran University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ahmadinejad', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran University of Medical Sciences, Tehran 14197-33141, Iran.'}, {'ForeName': 'Hamid Emadi', 'Initials': 'HE', 'LastName': 'Kouchak', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Jafari', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Seifi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh Shahmari', 'Initials': 'FS', 'LastName': 'Golestan', 'Affiliation': 'Department of Infectious Diseases, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghiasvand', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran University of Medical Sciences, Tehran 14197-33141, Iran. Electronic address: ghiasvand_62@yahoo.com.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106143']
2016,32854485,Effectiveness of Exercise on the Sequence Effect in Parkinson's Disease.,"OBJECTIVE


To determine the benefits of motor training on the sequence effect (SE), an essential component of bradykinesia in Parkinson's disease (PD).
METHODS


Seven patients with de novo PD participated in this study. The patients performed regular pentagon drawing tests and exercises during four visits. The first two visits occurred before the start of medication, and the last two visits occurred at least six months after the start of medication. We assessed the severity of bradykinesia and SE at each visit and compared the results before and after exercise in both the de novo and treatment conditions.
RESULTS


In the de novo condition, the severity of bradykinesia significantly improved after motor training (p = 0.018), but it did not resolve and only showed a trend of improvement after treatment (p = 0.068). The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
CONCLUSION


Our study suggests that regular motor training may be beneficial for the SE in PD.",2020,"The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
","[""Parkinson's disease (PD"", ""Parkinson's Disease"", 'Seven patients with de novo PD participated in this study']","['motor training', 'Exercise', 'regular motor training']","['severity of bradykinesia and SE', 'severity of the SE', 'severity of bradykinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",7.0,0.017575,"The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
","[{'ForeName': 'Suk Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of movement disorders,['10.14802/jmd.20045']
2017,32855385,Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trial.,"No effective drug treatments are available for coronavirus disease 2019 (COVID-19). Host-directed therapies targeting the underlying aberrant immune responses leading to pulmonary tissue damage, death, or long-term functional disability in survivors require clinical evaluation. We performed a parallel assigned controlled, non-randomized, phase 1 clinical trial to evaluate the safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusions in the treatment of patients with moderate and severe COVID-19 pulmonary disease. The study enrolled 18 hospitalized patients with COVID-19 (n = 9 for each group). The treatment group received three cycles of intravenous infusion of UC-MSCs (3 × 10 7  cells per infusion) on days 0, 3, and 6. Both groups received standard COVID-treatment regimens. Adverse events, duration of clinical symptoms, laboratory parameters, length of hospitalization, serial chest computed tomography (CT) images, the PaO 2 /FiO 2  ratio, dynamics of cytokines, and IgG and IgM anti-SARS-CoV-2 antibodies were analyzed. No serious UC-MSCs infusion-associated adverse events were observed. Two patients receiving UC-MSCs developed transient facial flushing and fever, and one patient developed transient hypoxia at 12 h post UC-MSCs transfusion. Mechanical ventilation was required in one patient in the treatment group compared with four in the control group. All patients recovered and were discharged. Our data show that intravenous UC-MSCs infusion in patients with moderate and severe COVID-19 is safe and well tolerated. Phase 2/3 randomized, controlled, double-blinded trials with long-term follow-up are needed to evaluate the therapeutic use of UC-MSCs to reduce deaths and improve long-term treatment outcomes in patients with serious COVID-19.",2020,Mechanical ventilation was required in one patient in the treatment group compared with four in the control group.,"['patients with moderate and severe COVID-19 pulmonary disease', 'patients with COVID-19', '18 hospitalized patients with COVID-19 (n\u2009=\u20099 for each group', 'patients with serious COVID-19']","['Human umbilical cord-derived mesenchymal stem cell therapy', 'human umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusions', 'standard COVID-treatment regimens', 'intravenous infusion of UC-MSCs']","['serious UC-MSCs infusion-associated adverse events', 'transient hypoxia', 'transient facial flushing and fever', 'safe and well tolerated', 'Mechanical ventilation', 'Adverse events, duration of clinical symptoms, laboratory parameters, length of hospitalization, serial chest computed tomography (CT) images, the PaO 2 /FiO 2  ratio, dynamics of cytokines, and IgG and IgM anti-SARS-CoV-2 antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",18.0,0.132743,Mechanical ventilation was required in one patient in the treatment group compared with four in the control group.,"[{'ForeName': 'Fanping', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Ruonan', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Junliang', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Tianjun', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Ji-Yuan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Jinwen', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Chunbao', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Maeurer', 'Affiliation': 'Immunotherapy Programme, Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Alimuddin', 'Initials': 'A', 'LastName': 'Zumla', 'Affiliation': 'Department of Infection, Division of Infection and Immunity, University College London, London, UK.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China. shiming302@sina.com.'}, {'ForeName': 'Fu-Sheng', 'Initials': 'FS', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China. fswang302@163.com.'}]",Signal transduction and targeted therapy,['10.1038/s41392-020-00286-5']
2018,32856619,"Effects of a Preoperative Carbohydrate-Rich Drink Before Ambulatory Surgery: A Randomized Controlled, Double-Blinded Study.","BACKGROUND The guidelines recommend oral carbohydrates up to 2 hr before elective surgery. The objective of this study was to explore the safety and feasibility of preoperative carbohydrate drink in patients undergoing ambulatory surgery. MATERIAL AND METHODS Patients undergoing ambulatory surgery under general anesthesia were enrolled. They were fasted from midnight and randomly assigned to a study group (200 mL of a carbohydrate beverage) or the control group (pure water) and received the assigned drink 2 hr before surgery. Bedside ultrasonography was performed to monitor gastric emptying at T₀ (before liquid intake), T₁ (5 min after intake), T₂ (1 hr after intake), and T₃ (2 hr after intake). Subjective feelings of thirst, hunger, anxiety, and fatigue were assessed 1 hr after liquid intake using the visual analogue scale (VAS). RESULTS In both groups, gastric antrum cross-sectional area, gastric content volume, and weight-corrected gastric content volume increased at T₁ and returned to baseline at T₃. These parameters were significantly higher in the study group at T₂ (6.28±1.38 vs. 4.98±0.78, 67.22±29.49 vs. 49.04±15.4, 1.10±0.51 vs. 0.85±0.37, P<0.05). Thirst and hunger VAS scores were reduced in both groups. The study group suffered significantly less hunger (28.44±10.41 vs. 36.03±14.42, P<0.05). Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels were similar in both groups at T₂. No gastric regurgitation or pulmonary aspiration was recorded. CONCLUSIONS Administration of 200 mL of oral carbohydrate beverage 2 hr before ambulatory surgery is safe, effective, and can be used for preoperative management of fasting patients.",2020,"Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels were similar in both groups at T₂. No gastric regurgitation or pulmonary aspiration was recorded.","['Patients undergoing ambulatory surgery under general anesthesia were enrolled', 'patients undergoing ambulatory surgery']","['Preoperative Carbohydrate-Rich Drink Before Ambulatory Surgery', 'preoperative carbohydrate drink', 'control group (pure water) and received the assigned drink 2 hr before surgery', 'Bedside ultrasonography']","['visual analogue scale (VAS', 'Thirst and hunger VAS scores', 'hunger ', 'Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels', 'Subjective feelings of thirst, hunger, anxiety, and fatigue', 'gastric antrum cross-sectional area, gastric content volume, and weight-corrected gastric content volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034193', 'cui_str': 'Pyloric antrum structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038352', 'cui_str': 'Gastric contents'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.061709,"Blood electrolytes (sodium, potassium, calcium) and glucose concentration levels were similar in both groups at T₂. No gastric regurgitation or pulmonary aspiration was recorded.","[{'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Rui-Ke', 'Initials': 'RK', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Qu-Lian', 'Initials': 'QL', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital Central South University, Changsha, Hunan, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.922837']
2019,32857315,"Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study.","INTRODUCTION


The aims of this study were to characterize the single-dose pharmacokinetics (PK) of the major active metabolites of ozanimod, CC112273 and CC1084037, and to evaluate the effect of gemfibrozil (a strong inhibitor of cytochrome P450 [CYP] 2C8), itraconazole (a strong inhibitor of CYP3A and P-glycoprotein [P-gp]), and rifampin (a strong inducer of CYP3A/P-gp and moderate inducer of CYP2C8) on the single-dose PK of ozanimod and its major active metabolites in healthy subjects.
METHODS


This was a phase 1, randomized, parallel-group, open-label study with two parts. In part 1, 40 subjects were randomized to receive a single oral dose of ozanimod 0.46 mg (group A, n = 20) or oral doses of gemfibrozil 600 mg twice daily for 17 days with a single oral dose of ozanimod 0.46 mg on day 4 (group B, n = 20). In part 2, 60 subjects were randomized to receive a single oral dose of ozanimod 0.92 mg (group C, n = 20), oral doses of itraconazole 200 mg once daily for 17 days with a single oral dose of ozanimod 0.92 mg on day 4 (group D, n = 20), or oral doses of rifampin 600 mg once daily for 21 days with a single oral dose of ozanimod 0.92 mg on day 8 (group E, n = 20). Plasma PK parameters for ozanimod, CC112273, and CC1084037 were estimated using noncompartmental methods.
RESULTS


Dose-proportional increases in maximum observed concentration (C max ) and area under the concentration-time curve (AUC) were observed for ozanimod, CC112273, and CC1084037. The mean terminal elimination half-life (t 1/2 ) for ozanimod was approximately 20-22 h while the mean t 1/2  for CC112273 and CC1084037 were approximately 10 days. CC112273 and CC1084037 exposures were highly correlated with or without interacting drugs. Itraconazole increased ozanimod AUC by approximately 13% while rifampin reduced ozanimod AUC by approximately 24%, suggesting a minor role of CYP3A and P-gp in the overall disposition of ozanimod. Gemfibrozil increased the AUC for CC112273 and CC1084037 by approximately 47% and 69%, respectively. Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
CONCLUSIONS


Ozanimod's major active metabolites, CC112273 and CC1084037, exhibited similar single-dose PK properties and their exposures were highly correlated. CYP2C8 is one of the important enzymes in the overall disposition of CC112273 and subsequently its direct metabolite CC1084037.
TRIAL REGISTRATION


Clinical trial: NCT03624959.",2020,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
","['In part\xa02, 60 subjects', '40 subjects', 'healthy subjects', 'Healthy Subjects']","['itraconazole', 'ozanimod 0.46\xa0mg (group\xa0A, n\u2009=\u200920) or oral doses of gemfibrozil 600\xa0mg twice daily for 17\xa0days with a single oral dose of ozanimod 0.46\xa0mg on day\xa04', 'Ozanimod', 'Itraconazole', 'ozanimod', 'gemfibrozil', 'rifampin 600\xa0mg once daily for 21\xa0days with a single oral dose of ozanimod 0.92', 'Gemfibrozil', 'Gemfibrozil, Itraconazole, or Rifampin', 'ozanimod 0.92']","['Plasma PK parameters', 'ozanimod AUC', 'maximum observed concentration (C max ) and area under the concentration-time curve (AUC', 'mean terminal elimination half-life', 'AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C4517460', 'cui_str': '0.46'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0993358', 'cui_str': 'Gemfibrozil 600 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017245', 'cui_str': 'Gemfibrozil'}, {'cui': 'C1104996', 'cui_str': 'Rifampin 600 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517485', 'cui_str': '0.92'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",40.0,0.103499,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
","[{'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA. dr.jtran@gmail.com.'}, {'ForeName': 'Peijin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Liangang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Syto', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Nonclinical Research and Development, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01473-0']
2020,32857949,Mastering the Complex Targeted Therapy for Non-small Cell Lung Cancer.,"In a recent Nature article, Middleton et al. report the National Lung Matrix trial results where patients with previously treated non-small cell lung cancer (NSCLC) are assigned to personalized therapy based on the results of a 28-gene next-generation sequencing panel test.",2020,report the National Lung Matrix trial results where patients with previously treated non-small cell lung cancer (NSCLC) are assigned to personalized therapy based on the results of a 28-gene next-generation sequencing panel test.,['patients with previously treated non-small cell lung cancer (NSCLC'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]",[],[],,0.0288593,report the National Lung Matrix trial results where patients with previously treated non-small cell lung cancer (NSCLC) are assigned to personalized therapy based on the results of a 28-gene next-generation sequencing panel test.,"[{'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Devarakonda', 'Affiliation': 'Alvin Siteman Cancer Center at Washington University, Washington University School of Medicine, 660 S Euclid Box 8056, St. Louis, MO, USA.'}, {'ForeName': 'Ramaswamy', 'Initials': 'R', 'LastName': 'Govindan', 'Affiliation': 'Alvin Siteman Cancer Center at Washington University, Washington University School of Medicine, 660 S Euclid Box 8056, St. Louis, MO, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Morgensztern', 'Affiliation': 'Alvin Siteman Cancer Center at Washington University, Washington University School of Medicine, 660 S Euclid Box 8056, St. Louis, MO, USA. Electronic address: Danielmorgensztern@wustl.edu.'}]",Cancer cell,['10.1016/j.ccell.2020.07.011']
2021,32857992,"Immunogenicity of a single-dose compared with a two-dose primary series followed by a booster dose of ten-valent or 13-valent pneumococcal conjugate vaccine in South African children: an open-label, randomised, non-inferiority trial.","BACKGROUND


Routine childhood immunisation with pneumococcal conjugate vaccine (PCV) has changed the epidemiology of pneumococcal disease across age groups, providing an opportunity to reconsider PCV dosing schedules. We aimed to evaluate the post-booster dose immunogenicity of ten-valent (PCV10) and 13-valent (PCV13) PCVs between infants randomly assigned to receive a single-dose compared with a two-dose primary series.
METHODS


We did an open-label, non-inferiority, randomised study in HIV-unexposed infants at a single centre in Soweto, South Africa. Infants were randomly assigned to receive one priming dose of PCV10 or PCV13 at ages 6 weeks (6w + 1 PCV10 and 6w + 1 PCV13 groups) or 14 weeks (14w + 1 PCV10 and 14w + 1 PCV13 groups) or two priming doses of PCV10 or PCV13, one each at ages 6 weeks and 14 weeks (2 + 1 PCV10 and 2 + 1 PCV13 groups); all participants then received a booster dose of PCV10 or PCV13 at 40 weeks of age. The primary endpoint was geometric mean concentrations (GMCs) of serotype-specific IgG 1 month after the booster dose, which was assessed in all participants who received PCV10 or PCV13 as per the assigned randomisation group and for whom laboratory results were available at that timepoint. The 1 + 1 vaccine schedule was considered non-inferior to the 2 + 1 vaccine schedule if the lower bound of the 96% CI for the GMC ratio was greater than 0·5 for at least ten PCV13 serotypes and eight PCV10 serotypes. Safety was a secondary endpoint. This trial is registered with ClinicalTrials.gov (NCT02943902) and is ongoing.
FINDINGS


Of 1695 children assessed, 600 were enrolled and randomly assigned to one of the six groups between Jan 9 and Sept 20, 2017; 542 were included in the final analysis of the primary endpoint (86-93 per group). For both PCV13 and PCV10, a 1+1 dosing schedule (either beginning at 6 or 14 weeks) was non-inferior to a 2 + 1 schedule. For PCV13, the lower limit of the 96% CI for the ratio of GMCs between the 1 + 1 and 2 + 1 groups was higher than 0·5 for ten serotypes in the 6w+1 group (excluding 6B, 14, and 23F) and 11 serotypes in the 14w + 1 group (excluding 6B and 23F). For PCV10, the lower limit of the 96% CI for the ratio of GMCs was higher than 0·5 for all ten serotypes in the 6w+1 and 14w + 1 groups. 84 serious adverse events were reported in 72 (12%) of 600 participants. 15 occurred within 28 days of vaccination, but none were considered to be related to PCV injection. There were no cases of culture-confirmed invasive pneumococcal disease.
INTERPRETATION


The non-inferiority in post-booster immune responses following a single-dose compared with a two-dose primary series of PCV13 or PCV10 indicates the potential for reducing PCV dosing schedules from a 2 + 1 to 1 + 1 series in low-income and middle-income settings with well established PCV immunisation programmes.
FUNDING


The Bill & Melinda Gates Foundation (OPP1 + 152352).",2020,84 serious adverse events were reported in 72 (12%) of 600 participants.,"['HIV-unexposed infants at a single centre in Soweto, South Africa', 'South African children', 'Of 1695 children assessed, 600 were enrolled and randomly assigned to one of the six groups between Jan 9 and Sept 20, 2017; 542 were included in the final analysis of the primary endpoint (86-93 per group']","['valent or 13-valent pneumococcal conjugate vaccine', 'pneumococcal conjugate vaccine (PCV', 'PCV10 or PCV13', 'ten-valent (PCV10) and 13-valent (PCV13) PCVs']","['84 serious adverse events', 'geometric mean concentrations (GMCs) of serotype-specific IgG 1 month', 'GMC ratio', 'Immunogenicity', 'ratio of GMCs']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': '10-valent pneumococcal conjugate vaccine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",600.0,0.279769,84 serious adverse events were reported in 72 (12%) of 600 participants.,"[{'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa. Electronic address: madhis@rmpru.co.za.'}, {'ForeName': 'Eleonora Aml', 'Initials': 'EA', 'LastName': 'Mutsaerts', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Welekazi', 'Initials': 'W', 'LastName': 'Boyce', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Sutika', 'Initials': 'S', 'LastName': 'Bhikha', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Benit T', 'Initials': 'BT', 'LastName': 'Ikulinda', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Nana', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moultrie', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Roalfe', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Dorfman', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30289-9']
2022,32859142,"p -Synephrine, the main protoalkaloid of  Citrus aurantium , raises fat oxidation during exercise in elite cyclists.","The aim of this study was to investigate the acute effects of  p -synephrine ingestion on substrate oxidation during exercise in elite cyclists. Fifteen elite cyclists volunteered to participate in a double blind, crossover, randomized and placebo-controlled experimental trial. During two different trials, participants either ingested a placebo (cellulose) or 3 mg/kg of  p -synephrine. After 60 min for substances absorption, participants performed an incremental maximal cycle ergometer test until volitional fatigue (25 W/min). Breath-by-breath gas exchange data was continuously recorded during the entire test to estimate energy expenditure, carbohydrate oxidation, and fat oxidation rates by stoichiometric equations. Heart rate was continuously measured by using a heart rate monitor. The ingestion of  p -synephrine had no significant effects on energy expenditure (F = 0.71,  P   =  0.40) or heart rate (F = 0.66,  P   =  0.43) during exercise. However, there was a main effect of  p -synephrine to increase the rate of fat oxidation over the placebo (F = 5.1,  P   =  0.04) and the rate of fat oxidation was higher with  p -synephrine in the following loads: 45 ± 2%, 51 ± 3%, 62 ± 3%, 67 ± 4%, 79 ± 5% and 85 ± 5% of the maximum wattage obtained in the test (all  P  < 0.05). The ingestion of  p -synephrine did not modify the maximal rate of fat oxidation during the ramp test (mean value; 95%CI =  0.91; 0.79-1.03 vs 1.01; 0.91-1.11 g/min, respectively,  P  = 0.06) nor the exercise intensity at which maximal fat oxidation was achieved (i.e. Fatmax =  49; 48-53 vs 50; 47-51% Wmax,  P  = 0.52). Acute  p -synephrine ingestion moved the fat oxidation-exercise intensity curve upwards during an incremental cycling test without affecting Fatmax.",2020,"p -synephrine had no significant effects on energy expenditure (F=0.71,  P= 0.40) or heart rate (F=0.66,  P= 0.43) during exercise.","['Fifteen elite cyclists volunteered to participate', 'elite cyclists']","['p -synephrine ingestion', 'placebo', 'placebo (cellulose) or 3 mg/kg of  p -synephrine', 'synephrine ingestion']","['exercise intensity at which maximal fat oxidation', 'substrate oxidation', 'rate of fat oxidation', 'Heart rate', 'heart rate', 'maximal rate of fat oxidation', 'energy expenditure']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0039086', 'cui_str': 'Synephrine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}]",,0.220604,"p -synephrine had no significant effects on energy expenditure (F=0.71,  P= 0.40) or heart rate (F=0.66,  P= 0.43) during exercise.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Francisco de Vitoria University, Faculty of Education, Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Baltazar-Martins', 'Affiliation': 'Camilo José Cela University, Exercise Physiology Laboratory, Madrid, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Rodríguez', 'Affiliation': 'Sports performance Lab, Reebok Sport Club, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Camilo José Cela University, Exercise Physiology Laboratory, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Camilo José Cela University, Exercise Physiology Laboratory, Madrid, Spain.'}, {'ForeName': 'Millán', 'Initials': 'M', 'LastName': 'Aguilar-Navarro', 'Affiliation': 'Francisco de Vitoria University, Faculty of Education, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University.'}]",European journal of sport science,['10.1080/17461391.2020.1817154']
2023,32881865,"Spatial spillover analysis of a cluster-randomized trial against dengue vectors in Trujillo, Venezuela.","BACKGROUND


The ability of cluster-randomized trials to capture mass or indirect effects is one reason for their increasing use to test interventions against vector-borne diseases such as malaria and dengue. For the same reason, however, the independence of clusters may be compromised if the distances between clusters is too small to ensure independence. In other words they may be subject to spillover effects.
METHODS


We distinguish two types of spatial spillover effect: between-cluster dependence in outcomes, or spillover dependence; and modification of the intervention effect according to distance to the intervention arm, or spillover indirect effect. We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index. We use a novel random effects Poisson spatial regression model. Spillover dependence is incorporated via an orthogonalized intrinsic conditional autoregression (ICAR) model. Spillover indirect effects are incorporated via the number of locations within a certain radius, set at 200m, that are in the intervention arm.
RESULTS


From the model with ICAR spatial dependence, and the degree of surroundedness, the intervention effect is estimated as 0.74-favouring the intervention-with a 95% credible interval of 0.34 to 1.69. The point estimates are stronger with increasing surroundedness within intervention locations.
CONCLUSION


In this trial there is some evidence of a spillover indirect effect of the intervention, with the Breteau index tending to be lower in locations which are more surrounded by locations in the intervention arm.",2020,"We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index.",[],[],[],[],[],[],,0.0575248,"We estimate these effects in trial of insecticide-treated materials against the dengue mosquito vector, Aedes aegypti, in Venezuela, the endpoint being the Breteau index.","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lenhart', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Anaya-Izquierdo', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008576']
2024,32882399,Long QT syndrome type 1 and 2 patients respond differently to arrhythmic triggers: The TriQarr in vivo study.,"BACKGROUND


In patients with long QT syndrome (LQTS), swimming and loud noises have been identified as genotype-specific arrhythmic triggers in LQTS type 1 (LQTS1) and LQTS type 2 (LQTS2), respectively.
OBJECTIVE


The purpose of this study was to compare LQTS group responses to arrhythmic triggers.
METHODS


LQTS1 and LQTS2 patients were included. Before and after beta-blocker intake, electrocardiograms were recorded as participants (1) were exposed to a loud noise of ∼100 dB; and (2) had their face immersed into cold water.
RESULTS


Twenty-three patients (9 LQTS1, 14 LQTS2) participated. In response to noise, LQTS groups showed similarly increased heart rate, but LQTS2 patients had corrected QT interval (Fridericia formula) (QTcF) prolonged significantly more than LQTS1 patients (37 ± 8 ms vs 15 ± 6 ms; P = .02). After intake of beta-blocker, QTcF prolongation in LQTS2 patients was significantly blunted and similar to that of LQTS1 patients (P = .90). In response to simulated diving, LQTS groups experienced a heart rate drop of ∼28 bpm, which shortened QTcF similarly in both groups. After intake of beta-blockers, heart rate dropped to 28 ± 2 bpm in LQTS1 patients and 20 ± 3 bpm in LQTS2, resulting in a slower heart rate in LQTS1 compared with LQTS2 (P = .01). In response, QTcF shortened similarly in LQTS1 and LQTS2 patients (57 ± 9 ms vs 36 ± 7 ms; P = .10).
CONCLUSION


When exposed to noise, LQTS2 patients had QTc prolonged significantly more than did LQTS1 patients. Importantly, beta-blockers reduced noise-induced QTc prolongation in LQTS2 patients, thus demonstrating the protective effect of beta-blockers. In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta-blocker intake.",2020,"In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta blockers.",['patients with long QT syndrome (LQTS'],"['LQTS1', 'TriQarr', 'LQTS']","['noise-induced QTc prolongation', 'QTcF prolongation', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023976', 'cui_str': 'Long QT syndrome'}]","[{'cui': 'C0023976', 'cui_str': 'Long QT syndrome'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",23.0,0.018453,"In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta blockers.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marstrand', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark. Electronic address: pmarstrand@hotmail.com.'}, {'ForeName': 'Kasim', 'Initials': 'K', 'LastName': 'Almatlouh', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jørgen K', 'Initials': 'JK', 'LastName': 'Kanters', 'Affiliation': 'Laboratory of Experimental Cardiology, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Graff', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Alex Hørby', 'Initials': 'AH', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Theilade', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}]",Heart rhythm,['10.1016/j.hrthm.2020.08.017']
2025,32883104,Effects of ON-Hours Versus OFF-Hours Admission on Outcome in Patients With Myocardial Infarction and Cardiogenic Shock: Results From the CULPRIT-SHOCK Trial.,"BACKGROUND


The management of patients with acute myocardial infarction complicated by cardiogenic shock is highly complex, and outcomes may depend on the time of hospital admission and subsequent intervention (ie, ON-hours versus OFF-hours). The CULPRIT-SHOCK trial (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) demonstrated superior outcome for culprit-lesion-only versus immediate multivessel percutaneous coronary intervention in patients presenting with acute myocardial infarction, multivessel disease, and cardiogenic shock. However, it is unknown whether the time of hospital admission affects the overall outcome of these high-risk patients.
METHODS


We analyzed patients from the CULPRIT-SHOCK trial with respect to the time of hospital admission. We divided patients in ON-hours and OFF-hours groups and further stratified them according to their individual revascularization strategy. Outcome measures consisted of a composite end point of death or renal-replacement therapy within 30 days and mortality within 1 year.
RESULTS


Out of 686 patients randomized in the CULPRIT-SHOCK trial, 444 patients (64.7%) presented during ON-hours, whereas 242 patients (35.3%) presented during OFF-hours. Death or renal-replacement therapy at 30 days occurred to a similar extent in patients admitted during ON-hours (51.0%) and OFF-hours (50.0%;  P =0.80). Similarly, 1-year mortality was not affected by the time of hospital admission (54.4% ON-hours versus 51.7% OFF-hours,  P =0.49). Regardless of admission time, patients had a benefit from culprit-lesion-only as compared to immediate multivessel percutaneous coronary intervention. The composite end point at 30 days occurred in 45.1% versus 57.6% of patients admitted ON-hours and in 47.7% versus 51.9% of patients admitted OFF-hours ( P interaction =0.29). Death within 1 year occurred in 49.4% versus 60.0% of patients admitted during ON-hours and in 51.4% versus 51.9% of patients admitted OFF-hours ( P interaction =0.20).
CONCLUSIONS


Among patients with myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days, and mortality at 1 year did not differ significantly according to the time of hospital admission. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01927549.",2020,"Death within 1 year occurred in 49.4% versus 60.0% of patients admitted during ON-hours and in 51.4% versus 51.9% of patients admitted OFF-hours ( P interaction =0.20).
","['patients with myocardial infarction and cardiogenic shock', 'patients with acute myocardial infarction', 'patients presenting with acute myocardial infarction, multivessel disease, and cardiogenic shock', '686 patients randomized in the CULPRIT-SHOCK trial, 444 patients (64.7%) presented during ON-hours, whereas 242 patients (35.3%) presented during OFF-hours', 'Patients With Myocardial Infarction and Cardiogenic Shock']","['ON-Hours Versus OFF-Hours Admission', 'multivessel percutaneous coronary intervention']","['risk of death or renal-replacement therapy', 'time of hospital admission', '1-year mortality', 'death or renal-replacement therapy within 30 days and mortality within 1 year', 'Death', 'Death or renal-replacement therapy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",686.0,0.118589,"Death within 1 year occurred in 49.4% versus 60.0% of patients admitted during ON-hours and in 51.4% versus 51.9% of patients admitted OFF-hours ( P interaction =0.20).
","[{'ForeName': 'Can Martin', 'Initials': 'CM', 'LastName': 'Sag', 'Affiliation': 'Department of Internal Medicine II, University Medical Center Regensburg, Germany (C.M.S., L.S.M.).'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut fuer Herzinfarktforschung, Ludwigshafen, Germany (U.Z., T.O., S.S.).'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut fuer Herzinfarktforschung, Ludwigshafen, Germany (U.Z., T.O., S.S.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Institut fuer Herzinfarktforschung, Ludwigshafen, Germany (U.Z., T.O., S.S.).'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.M.).'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Department of Cardiology, Wilhelminenspital and Sigmund Freud University, Medical School, Vienna, Austria (K.H.).'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Department of Internal Medicine/Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck, Germany (G.F.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (A.F., H.-J.F., S.D., H.T., L.S.M.).'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (A.F., H.-J.F., S.D., H.T., L.S.M.).'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (A.F., H.-J.F., S.D., H.T., L.S.M.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology and Leipzig Heart Institute, Germany (A.F., H.-J.F., S.D., H.T., L.S.M.).'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Maier', 'Affiliation': 'Department of Internal Medicine II, University Medical Center Regensburg, Germany (C.M.S., L.S.M.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009562']
2026,32883721,Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.,"INTRODUCTION


Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).
METHODS AND ANALYSIS


A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.
ETHICS AND DISSEMINATION


This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17-FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.
TRIAL REGISTRATION NUMBER


German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.",2020,"Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders.",['Two hundred eighty-six participants'],"['guided internet-based Acceptance and Commitment Therapy', 'Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT', 'ACT-based IMI', 'internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement', 'TAU']","['Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire', 'depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP', 'pain interference (Multidimensional Pain Interference scale; MPI', 'chronic pain', 'chronic pain-related disability']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0032741', 'cui_str': 'Positive reinforcement'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0663932', 'cui_str': 'SLPI protein, human'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",286.0,0.249744,"Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders.","[{'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Research Methods, Ulm University, Ulm, Baden-Württemberg, Germany yannik.terhorst@uni-ulm.de.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Clinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Buntrock', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ebert', 'Affiliation': 'GET.ON Institute, Hamburg, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Clinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-034271']
2027,32883723,Online cognitive-behavioural therapy for traumatically bereaved people: study protocol for a randomised waitlist-controlled trial.,"INTRODUCTION


The traumatic death of a loved one, such as death due to a traffic accident, can precipitate persistent complex bereavement disorder (PCBD) and comorbid post-traumatic stress disorder (PTSD) and depression. Waitlist-controlled trials have shown that grief-specific cognitive-behavioural therapy (CBT) is an effective treatment for such mental health problems. This is the first study that will examine the effectiveness of online CBT (vs waitlist controls) in a sample exclusively comprised of people bereaved by a traumatic death. Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist. We further expect that reductions in symptom levels during treatment are associated with reductions of negative cognitions and avoidance behaviours and the experience of fewer accident-related stressors. Moreover, the effect of the quality of the therapeutic alliance on treatment effects and drop-out rates will be explored.
METHODS AND ANALYSIS


A two-arm (online CBT vs waiting list) open-label parallel randomised controlled trial will be conducted. Participants will complete questionnaires at pretreatment and 12 and 20 weeks after study enrolment. Eligible for participation are Dutch adults who lost a loved one at least 1 year earlier due to a traffic accident and report clinically relevant levels of PCBD, PTSD and/or depression. Multilevel modelling will be used.
ETHICS AND DISSEMINATION


Ethics approval has been received by the Medical Ethics Review Board of the University Medical Center Groningen (METc UMCG: M20.252121). This study will provide new insights in the effectiveness of online CBT for traumatically bereaved people. If the treatment is demonstrated to be effective, it will be made publicly accessible. Findings will be disseminated among lay people (eg, through newsletters and media performances), our collaborators (eg, through presentations at support organisations), and clinicians and researchers (eg, through conference presentations and scientific journal articles).
TRIAL REGISTRATION NUMBER


NL7497.",2020,"Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist.","['traumatically bereaved people', 'Eligible for participation are Dutch adults who lost a loved one at least 1\u2009year earlier due to a traffic accident and report clinically relevant levels of PCBD, PTSD and/or depression']","['grief-specific cognitive-behavioural therapy (CBT', 'Online cognitive-behavioural therapy', 'online CBT']","['negative cognitions and avoidance behaviours', 'symptom levels', 'PCBD, PTSD and depression symptom levels', 'traumatic death']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2242593', 'cui_str': 'Traumatic death'}]",,0.108639,"Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist.","[{'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'Lenferink', 'Affiliation': 'Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands l.i.m.lenferink@rug.nl.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'de Keijser', 'Affiliation': 'Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Eisma', 'Affiliation': 'Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Smid', 'Affiliation': 'ARQ Nationaal Psychotrauma Centre, Diemen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Boelen', 'Affiliation': 'Clinical Psychology, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035050']
2028,32883724,How and why a multifaceted intervention to improve adherence post-MI worked for some (and could work better for others): an outcome-driven qualitative process evaluation.,"OBJECTIVES


To explore (1) the extent to which a multicomponent intervention addressed determinants of the desired behaviours (ie, adherence to cardiac rehabilitation (CR) and cardiovascular medications), (2) the associated mechanism(s) of action and (3) how future interventions might be better designed to meet the needs of this patient population.
DESIGN


A qualitative evaluation embedded within a multicentre randomised trial, involving purposive semistructured interviews.
SETTING


Nine cardiac centres in Ontario, Canada.
PARTICIPANTS


Potential participants were stratified according to the trial's primary outcomes of engagement and adherence, resulting in three groups: (1) engaged, adherence outcome positive, (2) engaged, adherence outcome negative and (3) did not engage, adherence outcome negative. Participants who did not engage but had positive adherence outcomes were excluded. Individual domains of the Theoretical Domains Framework were applied as deductive codes and findings were analysed using a framework approach.
RESULTS


Thirty-one participants were interviewed. Participants who were engaged with positive adherence outcomes attributed their success to the intervention's ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences. The behaviour of those with negative adherence outcomes was driven by beliefs about consequences, emotions and identity. As currently designed, the intervention failed to target these determinants for this subset of participants, resulting in partial engagement and poor adherence outcomes.
CONCLUSION


The intervention facilitated CR adherence through reinforcement, behavioural regulation, the provision of knowledge and social influence. To reach a broader and more diverse population, future iterations of the intervention should target aberrant beliefs about consequences, memory and decision-making and emotion.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry; NCT02382731.",2020,"Participants who were engaged with positive adherence outcomes attributed their success to the intervention's ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences.","['Thirty-one participants were interviewed', 'Participants who did not engage but had positive adherence outcomes were excluded', 'Nine cardiac centres in Ontario, Canada', 'Potential participants', 'Participants who were engaged with positive adherence outcomes']",[],"['adherence outcome positive, (2) engaged, adherence outcome negative and (3) did not engage, adherence outcome negative']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",31.0,0.0982231,"Participants who were engaged with positive adherence outcomes attributed their success to the intervention's ability to activate determinants including behavioural regulation and knowledge, which encouraged an increase in self-monitoring behaviour and awareness of available supports, as well as reinforcement and social influences.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada laura.desveaux@wchospital.ca.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Saragosa', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Kirstie', 'Initials': 'K', 'LastName': 'Russell', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Centre for Implementation Research, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Presseau', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'J-D', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Translation and Health Systems Research Program, Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Noah Michael', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-036750']
2029,32887548,Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study.,"BACKGROUND


The long-term safety and efficacy of fremanezumab were evaluated in a 52-week extension study (NCT02638103). Patient satisfaction with fremanezumab, dosing preferences, and patient-reported outcomes were assessed in a subpopulation who completed the extension study and consented to a follow-up questionnaire.
METHODS


In the extension study (N = 1842), adults with migraine were randomized to quarterly or monthly fremanezumab. After completing active treatment, patients answered a survey evaluating patient satisfaction, treatment and dosing preferences, and changes in patient-reported outcomes.
RESULTS


Of the 557 patients who could have been contacted upon completing the extension study, 302 consented and 253 completed the survey. The mean (standard deviation) satisfaction rating for fremanezumab was 6.1 (1.4; 1 = ""extremely dissatisfied"" to 7 = ""extremely satisfied""). Most patients (175 [69.2%]) preferred quarterly over monthly fremanezumab dosing. Among patients taking antiepileptics (most common class of prior preventive medication; n = 130), 91.5% preferred fremanezumab. Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab.
CONCLUSION


In this study, treatment satisfaction with fremanezumab was high, most patients preferred quarterly fremanezumab dosing, and fremanezumab was generally preferred to prior preventive medications.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02638103 (HALO LTS), registered December 22, 2015.",2020,"Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab.
","['patients taking antiepileptics (most common class of prior preventive medication; n\u2009=\u2009130), 91.5% preferred', 'adults with migraine', '557 patients who could have been contacted upon completing the extension study, 302 consented and 253 completed the survey']",['fremanezumab'],"['mean (standard deviation) satisfaction rating for fremanezumab', 'quality of time spent', 'anxiety', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0519529,"Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab.
","[{'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, 10461, USA. dbuse@montefiore.org.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Gandhi', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ramirez-Campos', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Blaine', 'Initials': 'B', 'LastName': 'Cloud', 'Affiliation': 'Clinical SCORE, Chadds Ford, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Cowan', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}]",The journal of headache and pain,['10.1186/s10194-020-01177-4']
2030,32858229,A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial.,"BACKGROUND


Gait and cognitive impairments are common in individuals with Multiple Sclerosis (MS) and can interfere with everyday function. Those with MS have difficulties executing cognitive tasks and walking simultaneously, a reflection of dual-task interference. Therefore, dual-task training may improve functional ambulation. Additionally, using technology such as virtual reality can provide personalized rehabilitation while mimicking real-world environments. The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms compared to conventional treadmill training.
METHODS


This study will be a single-blinded, two arm RCT with a six-week intervention period. 144 people with MS will be randomized into a treadmill training alone group or treadmill training with virtual reality group. Both groups will receive 18 sessions of training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system. Primary outcome measures include dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training.
DISCUSSION


This study will provide insight into the ability of a multi-modal cognitive-motor intervention to reduce dual-task cost and to enhance information processing speed in those with MS. This is one of the first studies that is powered to understand whether targeted dual-task training can improve MS symptoms and increase functional ambulation. We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.",2020,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"['people with multiple sclerosis', '144 people with MS', 'individuals with Multiple Sclerosis (MS']","['conventional treadmill training', 'combined cognitive-motor virtual reality training', 'modal virtual reality treadmill intervention', 'treadmill training alone group or treadmill training with virtual reality group', 'dual-task training', 'training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system']","['dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training', 'mobility and cognitive function', 'functional ambulation', 'dual-task gait speed and information processing speed', 'MS symptoms and increase functional ambulation', 'MS symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376392', 'cui_str': 'Virtual Systems'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",144.0,0.0521126,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shema-Shiratzky', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galperin', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Regev', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schmitz-Hübsch', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Devos', 'Affiliation': 'Laboratory for Advanced Rehabilitation Research in Simulation, Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sosnoff', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': ""Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Rush Alzheimer's Disease Center and Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA. Electronic address: jhausdor@tlvmc.gov.il.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106122']
2031,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2020,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
2032,32859666,"Protocol for the process evaluation of the Promoting Activity, Independence and Stability in Early Dementia (PrAISED), following changes required by the COVID-19 pandemic.","INTRODUCTION


The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) randomised controlled trial (RCT) is evaluating a home-based, face-to-face, individually tailored, activity and exercise programme for people living with dementia. Social distancing requirements following the COVID-19 pandemic necessitated rapid changes to intervention delivery.
METHODS AND ANALYSIS


A mixed-methods process evaluation will investigate how the changes were implemented and the impact that these have on participants' experience. An  implementation study  will investigate how the intervention was delivered during the pandemic. A  study on the mechanisms of impact and context  will investigate how these changes were experienced by the PrAISED participants, their carers and the therapists delivering the intervention. The study will commence in May 2020.
ETHICS AND DISSEMINATION


The PrAISED RCT and process evaluation have received ethical approval number 18/YH/0059. The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support. This will be valuable both in explaining trial results and also contribute to understanding and designing new ways of delivering home-based services and rehabilitation interventions for people with dementia and their carers.
TRIAL REGISTRATION NUMBER


ISRCTN15320670; Pre-results.",2020,"The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support.","['people living with dementia', 'people with dementia and their carers']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",[],[],,0.0812684,"The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Di Lorito', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK claudio.dilorito@nottingham.ac.uk.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bosco', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Goldberg', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'van der Wardt', 'Affiliation': 'Philipps-Universitat Marburg, Marburg, Hessen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Pollock', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Booth', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Pip', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Dunlop', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Horne', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Rowan H', 'Initials': 'RH', 'LastName': 'Harwood', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039305']
2033,32865169,Intravenous versus oral cyclophosphamide for lung and/or skin fibrosis in systemic sclerosis: an indirect comparison from EUSTAR and randomised controlled trials.,"OBJECTIVES


Both intravenous (IV) and oral (PO) cyclophosphamide (CYC) showed beneficial effects on skin and lung involvement in systemic sclerosis (SSc) in placebo-controlled randomised clinical trials and observational studies. Our goal was to compare the relative efficacy and safety of PO- versus IV-CYC for treating interstitial lung disease and/or skin involvement in SSc.
METHODS


Patients were derived from the EUSTAR centres and the Scleroderma Lung Studies I and II. A minimum of 6 months of CYC treatment and 12 months follow-up were required. Serious (SAEs) and non-serious adverse events and efficacy data (change in FVC%, DLCO%, mRSS) were analysed at the end of CYC treatment (EoT) and at follow-up (FU). Analysis included descriptive statistics and linear regressions.
RESULTS


Differences in ethnicity, previous DMARD exposure, previous and concomitant steroid exposure/dosage were observed in the PO (n=149) and IV (n=153) CYC groups. Adjusted and unadjusted changes in FVC%, DLCO% and mRSS were similar irrespective of mode of administration. PO patients had more leukopenia (p<0.001), haemorrhagic cystitis (p=0.011) and alopecia (p<0.001) at the EoT visit, while the IV group had more SAEs (p=0.025) and need for oxygen supplementation at FU (p=0.049).
CONCLUSIONS


In a comparison of PO- to IV-CYC for SSc, we found no differences in lung function or cutaneous sclerosis after one year. Some differences in side effects were seen. The results need to be considered as preliminary; however, because we needed to use a combination of RCT and registry data, with some differences in demographics and concomitant medications, well-controlled studies are warranted.",2020,"PO patients had more leukopenia (p<0.001), haemorrhagic cystitis (p=0.011) and alopecia (p<0.001) at the EoT visit, while the IV group had more SAEs (p=0.025) and need for oxygen supplementation at FU (p=0.049).
","['lung and/or skin fibrosis in systemic sclerosis', 'Patients were derived from the EUSTAR centres and the Scleroderma Lung Studies I and II']","['intravenous (IV) and oral (PO) cyclophosphamide (CYC', 'placebo', 'oral cyclophosphamide', 'PO- versus IV-CYC']","['haemorrhagic cystitis', 'leukopenia', 'SAEs (p=0.025) and need for oxygen supplementation', 'FVC%, DLCO% and mRSS', 'lung function or cutaneous sclerosis', 'side effects', 'alopecia', 'Serious (SAEs) and non-serious adverse events and efficacy data (change in FVC%, DLCO%, mRSS']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0263008', 'cui_str': 'Fibrosis of the skin'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085692', 'cui_str': 'Hemorrhagic cystitis'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C1845861', 'cui_str': 'X-linked intellectual disability Cabezas type'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0576603,"PO patients had more leukopenia (p<0.001), haemorrhagic cystitis (p=0.011) and alopecia (p<0.001) at the EoT visit, while the IV group had more SAEs (p=0.025) and need for oxygen supplementation at FU (p=0.049).
","[{'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Bruni', 'Affiliation': 'Department of Experimental and Clinical Medicine, Division of Rheumatology, University of Firenze, Italy. cosimobruni85@gmail.com.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'Division of Pulmonary Medicine and Critical Care, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Rheumatology Division, Department of Medicine, Georgetown University, Washington DC, USA.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Université Paris Descartes, Sorbonne Paris Cité, Service de Rhumatologie A, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Grotts', 'Affiliation': 'Department of Medicine Statistics Core, University of California at Los Angeles, CA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Matucci-Cerinic', 'Affiliation': 'Department of Experimental and Clinical Medicine, Division of Rheumatology, University of Firenze, Italy.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Experimental and Clinical Medicine, Division of Rheumatology, University of Firenze, Italy, and Department of Medicine, Division of Rheumatology, University of California Los Angeles, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental rheumatology,[]
2034,32861377,Remote ischemic preconditioning for prevention of contrast-induced nephropathy - A randomized control trial.,"BACKGROUND


There is a lack of sufficient data regarding the protective effects of remote ischemic preconditioning (RIPC) in patients at risk of developing contrast-induced nephropathy (CIN). Thus, this study was conducted to determine whether RIPC as an adjunct to standard therapy prevents CIN in high-risk patients undergoing coronary intervention.
METHODS


In a single-center, double-blinded, randomized controlled trial, 162 patients who were at risk of CIN received standard hydration combined with RIPC or hydration with sham preconditioning. RIPC was accomplished by four cycles of 5 min ischemia and 5 min reperfusion of the forearm. The primary endpoint was a rise in serum creatinine (>0.5 mg/dL or >25%) from baseline to serum creatinine 48-72 h after contrast administration.
RESULTS


Of the 162 patients, 81 were randomly allocated to receive sham preconditioning and 81 to receive RIPC. Significantly reduced serum creatinine levels were observed in patients with a Mehran moderate risk allocated to sham group compared to the RIPC group (0.070 ± 0.16 mg/dL vs. 0.107 ± 0.13 mg/dL, p = 0.001). With regards to the primary endpoint, a significantly higher change in serum creatinine from baseline to 48-72 h was observed in the sham group compared to the RIPC group (0.023 ± 0.2 μmol/L vs -0.064 ± 0.1 μmol/L, p < 0.001).
CONCLUSION


RIPC as an alternative to standard therapy, improved serum creatinine levels after contrast administration in patients at risk of CIN. However, present data indicate that RIPC might have beneficial effects in patients with a moderate or high risk of CIN.",2020,Significantly reduced serum creatinine levels were observed in patients with a Mehran moderate risk allocated to sham group compared to the RIPC group (0.070 ± 0.16 ,"['patients with a moderate or high risk of CIN', 'patients at risk of developing contrast-induced nephropathy (CIN', 'high-risk patients undergoing coronary intervention', '162 patients', '162 patients who were at risk of CIN received']","['RIPC', 'sham preconditioning and 81 to receive RIPC', 'Remote ischemic preconditioning', 'standard hydration combined with RIPC or hydration with sham preconditioning', 'remote ischemic preconditioning (RIPC']","['rise in serum creatinine', 'serum creatinine levels', 'serum creatinine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",162.0,0.467333,Significantly reduced serum creatinine levels were observed in patients with a Mehran moderate risk allocated to sham group compared to the RIPC group (0.070 ± 0.16 ,"[{'ForeName': 'Akshay Ashok', 'Initials': 'AA', 'LastName': 'Bafna', 'Affiliation': 'Department of Cardiology, Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, India. Electronic address: drbafnaakshay@gmail.com.'}, {'ForeName': 'Hetan C', 'Initials': 'HC', 'LastName': 'Shah', 'Affiliation': 'Department of Cardiology, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, India.'}]",Indian heart journal,['10.1016/j.ihj.2020.04.010']
2035,32861841,Longitudinal trajectories of mood symptoms and global functioning in youth at high risk for bipolar disorder.,"BACKGROUND


Little is known about the longitudinal course of mood symptoms and functioning in youth who are at high risk for bipolar disorder (BD). Identifying distinct course trajectories and predictors of those trajectories may help refine treatment approaches.
METHODS


This study examined the longitudinal course of mood symptoms and functioning ratings in 126 youth at high risk for BD based on family history and early mood symptoms. Participants were enrolled in a randomized trial of family-focused therapy and followed longitudinally (mean 2.0 years, SD = 53.6 weeks).
RESULTS


Using latent class growth analyses (LCGA), we observed three mood trajectories. All youth started the study with active mood symptoms. Following the index mood episode, participants were classified as having a ""significantly improving course"" (n = 41, 32.5% of sample), a ""moderately symptomatic course"" (n = 21, 16.7%), or a ""predominantly symptomatic course"" (n = 64, 50.8%) at follow-up. More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness. LCGA also revealed three trajectories of global functioning that closely corresponded to symptom trajectories; however, fewer youth exhibited functional recovery than exhibited symptomatic recovery.
LIMITATIONS


Mood trajectories were assessed within the context of a treatment trial. Ratings of mood and functioning were based on retrospective recall.
CONCLUSIONS


This study suggests considerable heterogeneity in the course trajectories of youth at high risk for BD, with a significant proportion (32.5%) showing long-term remission of symptoms. Treatments that enhance psychosocial functioning may be just as important as those that ameliorate symptoms in youth at risk for BD.",2020,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","['126 youth at high risk for BD based on family history and early mood symptoms', 'youth at high risk for bipolar disorder', 'youth who are at high risk for bipolar disorder (BD']",['LCGA'],"['severe depression, anxiety, and suicidality']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0524716,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.018']
2036,32861983,Can 'floating' predict treatment response to ketamine? Data from three randomized trials of individuals with treatment-resistant depression.,"Ketamine has rapid-acting antidepressant properties but also potentially concerning transient dissociative side effects (SEs). Recent studies noted a positive correlation between treatment response to ketamine and general dissociative SEs, as well as ""floating"", a depersonalization SE (a subtype of the dissociative SEs). This analysis sought to determine whether floating mediates treatment response to ketamine. Data were pooled from three double-blind, crossover, placebo-controlled ketamine clinical trials across which 82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder) received placebo and ketamine (0.5 mg/kg) infusions. SEs were actively solicited in a standardized fashion before and after ketamine infusion. The hypothesis that a post-infusion experience of floating would mediate antidepressant response to ketamine was assessed at 230 min post-infusion and at Day 1. Montgomery-Asberg Depression Rating Scale (MADRS) total score was the dependent variable in a linear mixed effects model. Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion. The hypothesized mediation effect of floating was also not detected at either 230 min or Day 1 post-infusion. Taken together, the findings do not support the hypothesis that ketamine's antidepressant effects are mediated by the dissociative depersonalization subtype SE of floating.",2020,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","['82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder', 'individuals with treatment-resistant depression']","['placebo and ketamine', 'ketamine', 'placebo-controlled ketamine', 'Ketamine']","['MADRS scores', 'floating and MADRS score', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.226109,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","[{'ForeName': 'Elia E', 'Initials': 'EE', 'LastName': 'Acevedo-Diaz', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. Electronic address: elia.acevedo@gmail.com.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Cavanaugh', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Dede', 'Initials': 'D', 'LastName': 'Greenstein', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.012']
2037,32862111,Interferon β-1b in treatment of severe COVID-19: A randomized clinical trial.,"In this study, efficacy and safety of interferon (IFN) β-1b in the treatment of patients with severe COVID-19 were evaluated. Among an open-label, randomized clinical trial, adult patients (≥18 years old) with severe COVID-19 were randomly assigned (1:1) to the IFN group or the control group. Patients in the IFN group received IFN β-1b (250 mcg subcutaneously every other day for two consecutive weeks) along with the national protocol medications while in the control group, patients received only the national protocol medications (lopinavir/ritonavir or atazanavir/ritonavir plus hydroxychloroquine for 7-10 days). The primary outcome of the study was time to clinical improvement. Secondary outcomes were in-hospital complications and 28-daymortality. Between April 20 and May 20, 2020, 80 patients were enrolled and finally 33 patients in each group completed the study. Time to clinical improvment in the IFN group was significantly shorter than the control group ([9(6-10) vs. 11(9-15) days respectively, p = 0.002, HR = 2.30; 95% CI: 1.33-3.39]). At day 14, the percentage of discharged patients was 78.79% and 54.55% in the IFN and control groups respectively (OR = 3.09; 95% CI: 1.05-9.11, p = 0.03). ICU admission rate in the control group was significantly higher than the IFN group (66.66% vs. 42.42%, p = 0.04). The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (p = 0.12). IFN β-1b was effective in shortening the time to clinical improvement without serious adverse events in patients with severe COVID-19. Furthermore, admission in ICU and need for invasive mechanical ventilation decreased following administration of IFN β-1b. Although 28-day mortality was lower in the IFN group, further randomized clinical trials with large sample size are needed for exact estimation of survival benefit of IFN β-1b.",2020,The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (,"['patients with severe COVID-19', 'severe COVID-19', 'patients with severe COVID-19 were evaluated', 'adult patients (≥18\xa0years old) with severe COVID-19', 'Between April 20 and May 20, 2020, 80 patients were enrolled and finally 33 patients in each group completed the study']","['interferon (IFN) β-1b', 'IFN', 'IFN β-1b', 'national protocol medications (lopinavir/ritonavir or atazanavir/ritonavir plus hydroxychloroquine', 'Interferon β-1b']","['ICU admission rate', 'Time to clinical improvment', '28-day mortality', 'invasive mechanical ventilation', 'hospital complications and 28-daymortality', 'duration of hospitalization and ICU stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",80.0,0.104399,The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (,"[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Nourian', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: khalilih@tums.ac.ir.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Hajizadeh', 'Affiliation': 'Department of Infectious Diseases, Shohadaye Gomnam Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narjes Zarei', 'Initials': 'NZ', 'LastName': 'Jalalabadi', 'Affiliation': 'Department of Internal Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Fazeli', 'Affiliation': 'Department of Food and Drug Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Ghazaeian', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran Univesity of Medical Sciences, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106903']
2038,32862662,Initial Invasive versus Conservative Management of Stable Ischemic Heart Disease Patients with a History of Heart Failure or Left Ventricular Dysfunction: Insights from the ISCHEMIA Trial.,"Background:  It is unknown whether an initial invasive strategy in patients with stable ischemic heart disease and at least moderate ischemia improves outcomes in patients with a history of heart failure (HF) or left ventricular dysfunction (LVD) when EF ≥35%, but <45%.  Methods:  Among 5179 participants randomized into the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), all of whom had LVEF ≥35%, we compared cardiovascular outcomes by treatment strategy in those with a history of HF or LV dysfunction (HF/LVD) at baseline versus those without HF/LVD. Median followup was 3.2 years.  Results:  There were 398 (7.7%) participants with HF/LVD at baseline of whom 177 had HF/LVEF>45%, 28 had HF/LVEF 35-45% and 193 had LVEF 35-45% but no prior history of HF. HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension. Compared to those without HF/LVD, those with HF/LVD were more likely to experience a primary outcome composite of cardiovascular death, nonfatal MI, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest; four-year cumulative incidence rate (22.7% vs. 13.8%), cardiovascular death or MI (19.7% vs. 12.3%), and all-cause death or HF (15.0% vs. 6.9%). Those with HF/LVD randomized to the invasive versus conservative strategy had a lower rate of the primary outcome (17.2% vs. 29.3%, difference in 4-year event rate -12.1%; 95% CI: -22.6, -1.6%), whereas those without HF/LVD did not (13.0% vs. 14.6%, difference in 4-year event rate -1.6%; 95% CI: -3.8%, 0.7%; p-interaction = 0.055). A similar differential effect was seen for the primary outcome, all-cause mortality, and CV mortality when invasive versus conservative strategy associated outcomes were analyzed with LVEF as a continuous variable for those with and without prior HF.  Conclusions:  ISCHEMIA trial participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD were at increased risk for the primary outcome. In the small, high-risk subgroup with HF and LVEF 35-45%, an initial invasive approach was associated with a better event-free survival. This result should be considered hypothesis generating.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT01471522.",2020,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","['5179 participants', 'Stable Ischemic Heart Disease Patients with a History of Heart Failure or Left Ventricular Dysfunction', 'participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD', 'patients with stable ischemic heart disease', 'patients with a history of heart failure (HF) or left ventricular dysfunction (LVD']",['Initial Invasive versus Conservative Management'],"['better event-free survival', 'cardiovascular death or MI', 'cause mortality, and CV mortality', 'cardiovascular death, nonfatal MI, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest; four-year cumulative incidence rate', 'myocardial infarction (MI), stroke and hypertension']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",5179.0,0.202193,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Susanna R', 'Initials': 'SR', 'LastName': 'Stevens', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York NY.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Pina', 'Affiliation': 'Wayne State Univ/Central Michigan University, Detroit, MI.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, IdiPaz, CIBER-CV. Madrid, Spain.'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Farsky', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E. Meshalkin National medical research center of the Ministry of Health of the Russian Federation (E.Meshalkin NMRC), Russia.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'CIUSSSMCQ, University of Montreal, Campus Mauricie, Trois-Rivieres, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Phaneuf', 'Affiliation': 'Hôpital Pierre-Le Gardeur, Quebec, Canada.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'DeBelder', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Yi-Tong', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Guzman', 'Affiliation': 'DAMIC Medical Institute, Cordoba, Argentina.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Khouri', 'Affiliation': 'Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Intensive Cardiac Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau, CIBER-CV, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hausenloy', 'Affiliation': 'The Hatter Cardiovascular Institute, Institute of Cardiovascular Sciences, University College London, London, UK; Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, Singapore; National Heart Research Institute Singapore, National Heart Centre, Singapore; Yong Loo Lin School of Medicine, National University Singapore, Singapore; Cardiovascular Research Center, College of Medical and Health Sciences, Asia University, Taiwan.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': 'Praxisklinik Herz und Gefaesse, Dresden, Germany.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': 'Flinders Medical Centre, Adelaide, Australia.'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, CA.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050304']
2039,32863109,Transcranial direct current stimulation improves tinnitus perception and modulates cortical electrical activity in patients with tinnitus: A randomized clinical trial.,"OBJECTIVES


This study aims to determine whether transcranial direct current stimulation (tDCS): a) is effective in the treatment of tinnitus by decreasing its annoyance and severity; b) modulates the cortical electrical activity of such individuals.
METHODS


A double-blind, placebo-controlled clinical trial was conducted with 24 patients with tinnitus, randomized into two groups: Group 1 (n = 12) received anodal tDCS over the left temporoparietal area (LTA) and cathodal tDCS over the right dorsolateral prefrontal cortex (DLPFC) and Group 2 (n = 12) received placebo intervention. Tinnitus perception using a visual analog scale (VAS) and the Tinnitus Handicap Inventory (THI) questionnaire, in addition to electroencephalogram (EEG) was measured with eyes opened and closed at baseline and after the intervention. For the treatment, patients were subjected to five consecutive sessions of tDCS with the anodal electrode over the LTA and cathodal electrode over the right DLPFC (7 × 5 cm, 2 mA for 20 min). tDCS was turned off after 30 s in the sham group.
RESULTS


Active tDCS significantly improved tinnitus annoyance and severity. It was associated with decreased beta and theta EEG frequency bands with eyes opened and decreased alpha frequency with eyes closed. sLORETA identified changes in frequency bands in the frontal, temporoparietal, and limbic regions. Finally, there were negative correlations between baseline EEG frequency bands and tDCS-induced change in tinnitus annoyance and severity.
CONCLUSIONS


These results demonstrate that tDCS modulates the EEG activity and alleviates tinnitus perception. This effect may be related to baseline EEG activity.",2020,"Finally, there were negative correlations between baseline EEG frequency bands and tDCS-induced change in tinnitus annoyance and severity.
","['patients with tinnitus', '24 patients with tinnitus']","['placebo intervention', 'tDCS', 'placebo', 'tDCS with the anodal electrode over the LTA and cathodal electrode over the right DLPFC', 'anodal tDCS over the left temporoparietal area (LTA) and cathodal tDCS over the right dorsolateral prefrontal cortex (DLPFC', 'Transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS']","['tinnitus perception and modulates cortical electrical activity', 'EEG activity and alleviates tinnitus perception', 'tinnitus annoyance and severity', 'Tinnitus perception using a visual analog scale (VAS) and the Tinnitus Handicap Inventory (THI) questionnaire, in addition to electroencephalogram (EEG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332287', 'cui_str': 'With'}]",24.0,0.106551,"Finally, there were negative correlations between baseline EEG frequency bands and tDCS-induced change in tinnitus annoyance and severity.
","[{'ForeName': 'Dayse da Silva', 'Initials': 'DDS', 'LastName': 'Souza', 'Affiliation': 'Graduate Program in Cognitive Neuroscience and Behavior, Federal University of Paraiba, João Pessoa, Brazil. Electronic address: dayse.s.s@hotmail.com.'}, {'ForeName': 'Alexandre Alex', 'Initials': 'AA', 'LastName': 'Almeida', 'Affiliation': 'Graduate Program in Cognitive Neuroscience and Behavior, Federal University of Paraiba, João Pessoa, Brazil.'}, {'ForeName': 'Suellen Marinho Dos Santos', 'Initials': 'SMDS', 'LastName': 'Andrade', 'Affiliation': 'Graduate Program in Cognitive Neuroscience and Behavior, Federal University of Paraiba, João Pessoa, Brazil. Electronic address: suellenandrade@gmail.com.'}, {'ForeName': 'Daniel Gomes da Silva', 'Initials': 'DGDS', 'LastName': 'Machado', 'Affiliation': 'Graduate Program in Collective Health, Federal University of Rio Grande do Norte (UFRN), Natal, Brazil. Electronic address: profdmachado@gmail.com.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Leitão', 'Affiliation': 'Department of Classical and Vernacular Letters, Federal University of Paraíba, Brazil.'}, {'ForeName': 'Tanit Ganz', 'Initials': 'TG', 'LastName': 'Sanchez', 'Affiliation': 'University of São Paulo School of Medicine, São Paulo, Brazil; Ganz Sanches Institute of Integrated Otorhinolaryngology, São Paulo, Brazil.'}, {'ForeName': 'Marine Raquel Diniz da', 'Initials': 'MRDD', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program in Cognitive Neuroscience and Behavior, Federal University of Paraiba, João Pessoa, Brazil. Electronic address: mrdrosa@yahoo.com.br.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2020.07.002']
2040,32864319,"Corrigendum to ""Comparison of Purgative Manna Drop and Phototherapy with Phototherapy Treatment of Neonatal Jaundice: A Randomized Double-Blind Clinical Trial"" [Osong Public Health Res Perspect 2019;10(3):152-7].","[This corrects the article on p. 152 in vol. 10, PMID: 31263664.].",2020,"[This corrects the article on p. 152 in vol. 10, PMID: 31263664.].",['Neonatal Jaundice'],['Purgative Manna Drop and Phototherapy with Phototherapy'],[],"[{'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}]","[{'cui': 'C3885740', 'cui_str': 'purgative manna'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]",[],,0.387744,"[This corrects the article on p. 152 in vol. 10, PMID: 31263664.].","[{'ForeName': 'Amirreza', 'Initials': 'A', 'LastName': 'Monsef', 'Affiliation': 'Pediatric Department, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Eghbalian', 'Affiliation': 'Pediatric Department, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Rahimian', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}]",Osong public health and research perspectives,['10.24171/j.phrp.2020.11.4.17']
2041,32868130,Immunogenicity of influenza vaccines administered to pregnant women in randomized clinical trials in Mali and South Africa.,"BACKGROUND


A key consideration for expanding recommendations for influenza vaccination is a robust assessment of immunogenicity and efficiency of transplacental antibody transfer after maternal vaccination.
METHODS


We pooled data from two trials of maternal influenza vaccination to analyze vaccine immunogenicity with more power than either trial had alone. We compared hemagglutination-inhibition (HAI) titers and titer factor change for women and their infants between trial arms using t-tests; maternal and infant putative seroprotective titers (HAI ≥ 1:40) within each trial arm and maternal seroconversion between trial arms using exact tests; and transplacental antibody transfer between trial arms using t-tests. We used marginal linear models and generalized estimating equations to examine the impact of time between maternal vaccination and delivery on transplacental antibody transfer, infant titers, and infant seroprotection.
RESULTS


For all vaccine components (A/H1N1, A/H3N2, and Type B), >80% of vaccinated women had seroprotective titers, >60% of them seroconverted, and >50% of their infants were born with seroprotective titers. These immunogenicity outcomes occurred more often in vaccine recipients and their infants than in controls. No difference in efficiency of transplacental antibody transfer was observed between vaccine recipients and controls.
CONCLUSIONS


Our results provide robust support for further expansion of maternal influenza vaccination recommendations.
CLINICAL TRIALS REGISTRATION


NCT01430689 and NCT01306669.",2020,"No difference in efficiency of transplacental antibody transfer was observed between vaccine recipients and controls.
",['pregnant women in randomized clinical trials in Mali and South Africa'],['influenza vaccines'],"['hemagglutination-inhibition (HAI) titers and titer factor change', 'immunogenicity outcomes', 'seroprotective titers', 'transplacental antibody transfer', 'transplacental antibody transfer, infant titers, and infant seroprotection', 'Immunogenicity', 'efficiency of transplacental antibody transfer']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.205737,"No difference in efficiency of transplacental antibody transfer was observed between vaccine recipients and controls.
","[{'ForeName': 'Avnika B', 'Initials': 'AB', 'LastName': 'Amin', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, USA. Electronic address: avnika.amin@emory.edu.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology-National Research Foundation, Vaccine-Preventable Diseases, Johannesburg, South Africa.'}, {'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali; University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, USA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology-National Research Foundation, Vaccine-Preventable Diseases, Johannesburg, South Africa.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology-National Research Foundation, Vaccine-Preventable Diseases, Johannesburg, South Africa.'}, {'ForeName': 'Niteen', 'Initials': 'N', 'LastName': 'Wairagkar', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, USA.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, USA; Hubert Department of Global Health, Emory University Rollins School of Public Health, Atlanta, USA; Emory Vaccine Center, Atlanta, USA; Department of Pediatrics, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.07.020']
2042,32866619,Aerobic exercise training partially reverses the impairment of Nrf2 activation in older humans.,"Nuclear factor erythroid-2-related factor 2 (Nrf2), is an inducible transcription factor that improves redox balance through stimulating antioxidant gene expression. In older humans the Nrf2 response to a single bout of acute exercise is blunted compared to young indicating impaired redox signaling. The purpose of this randomized controlled trial was to investigate if the signaling impairment could be reversed with exercise training in older men and women, while also comparing to young. Young (18-28y, n = 21) and older (≥60y, n = 19) men and women were randomized to 8-week aerobic exercise training (ET; 3 d/wk, 45 min/d) or a non-exercise control group (CON). Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein were measured in PBMCs in response to acute exercise trial (AET; 30-min cycling at 70% VO 2  peak pre- and post-intervention at 7 timepoints (Pre, +10 m, +30 m, +1 h, +4 h, +8 h, +24 h). Young had greater Nrf2 signaling response compared to older at pre-intervention (p = 0.05), whereas the older had significantly higher basal Nrf2 levels (p = 0.004). ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05). The degree of restoration in Nrf2 signaling response was related to the degree of change in basal Nrf2 (p = 0.039), which was driven by older adults (p = 0.014). Lower basal nuclear Nrf2 levels were associated with changes seen in AET responses for Nrf2 and GCLC protein, as well as NQO1 and GCLC mRNA. Together these data demonstrate that exercise training improves Nrf2 signaling and downstream gene expression and that lower basal Nrf2 levels are associated with a more dynamic acute response. Our results provide evidence that the impaired Nrf2 signaling in sedentary older adults can be restored to a degree with moderate exercise training, albeit not to the level seen in young. CLINICALTRIALS.GOV ID: NCT03419988.",2020,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"['sedentary older adults', 'older humans', 'older men and women, while also comparing to young', 'Young (18-28y, n\u202f=\u202f21) and older (≥60y, n\u202f=\u202f19) men and women']","['Aerobic exercise training', 'aerobic exercise training (ET; 3\u202fd/wk, 45\u202fmin/d) or a non-exercise control group (CON', 'exercise training', 'CON']","['Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein', 'Nrf2 signaling response', 'basal Nrf2 levels', 'basal Nrf2 expression', 'impairment of Nrf2 activation', 'Nrf2 signaling and downstream gene expression']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1136197', 'cui_str': 'NAD(P)H dehydrogenase (quinone) 1, human'}, {'cui': 'C0018969', 'cui_str': 'Heme oxygenase (decyclizing)'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}]",,0.0441431,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"[{'ForeName': 'Ethan L', 'Initials': 'EL', 'LastName': 'Ostrom', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Tinna', 'Initials': 'T', 'LastName': 'Traustadóttir', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA. Electronic address: tinna.traustadottir@nau.edu.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.08.016']
2043,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE


This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS


Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS


Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS


The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2020,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
2044,32888187,The 90% effective dose of intranasal dexmedetomidine for procedural sedation in children with congenital heart disease before and after surgery: A biased-coin design up-and-down sequential allocation trial.,"BACKGROUND


Intranasal dexmedetomidine can provide adequate sedation during short procedures. However, there are few reports investigating the effective dose of intranasal dexmedetomidine for sedation in children with congenital heart disease (CHD) before and after surgery.
METHODS


Children aged 13-36 months with acyanotic CHD requiring trans-thoracic echocardiography before cardiac surgery were recruited for this study. One month after the cardiac surgery, the same children were studied again. The 90% effective dose was established using a biased-coin design up-and-down sequential method. Onset time, examination time, wake-up time and adverse effects were measured. Safety was evaluated in terms of changes in vital signs.
RESULTS


A total of fifty-eight subjects were recruited for this study. The 90% effective dose of intranasal dexmedetomidine for sedation was 2.13 μg/kg (95% CI, 1.73-2.34 μg/kg) in children with CHD before cardiac surgery and 3.51 μg/kg (95% CI, 2.99-3.63 μg/kg) after cardiac surgery (P < .01). There were no differences between the groups in terms of demographic variables, onset time, examination time, wake-up time or adverse effects.
CONCLUSIONS


The 90% effective dose of intranasal dexmedetomidine for sedation in children with CHD was 2.13 μg/kg before cardiac surgery and 3.51 μg/kg after cardiac surgery.",2020,"There were no differences between the groups in terms of demographic variables, onset time, examination time, wake-up time or adverse effects.
","['children with congenital heart disease before and after surgery', 'A total of fifty-eight subjects', 'Children aged 13-36 months with acyanotic congenital heart disease requiring trans-thoracic echocardiography before cardiac surgery were recruited for this study', 'children with congenital heart disease was 2.13 μg/kg before cardiac surgery and 3.51 μg/kg after cardiac surgery']","['intranasal dexmedetomidine', 'dexmedetomidine']","['Onset time, examination time, wake-up time and adverse effects', 'Safety', 'demographic variables, onset time, examination time, wake-up time or adverse effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0265807', 'cui_str': 'Acyanotic congenital heart disease'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",58.0,0.377805,"There were no differences between the groups in terms of demographic variables, onset time, examination time, wake-up time or adverse effects.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'YuJiao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'ShangYingYing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'ShengFen', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13693']
2045,32888453,"Durvalumab with first-line chemotherapy in previously untreated malignant pleural mesothelioma (DREAM): a multicentre, single-arm, phase 2 trial with a safety run-in.","BACKGROUND


There is a strong unmet need to improve systemic therapy in mesothelioma. Chemotherapy with cisplatin and pemetrexed improves survival in malignant pleural mesothelioma, and immune checkpoint inhibitors are an emerging treatment in this disease. We aimed to evaluate the activity of durvalumab, an anti-PD-L1 antibody, given during and after first-line chemotherapy with cisplatin and pemetrexed in patients with advanced malignant pleural mesothelioma.
METHODS


DREAM was a multicentre, single-arm, open-label, phase 2 trial done in nine hospitals in Australia. Eligible patients were aged 18 years or older and had histologically confirmed malignant pleural mesothelioma considered unsuitable for cancer-directed surgery, an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease as per the modified Response Evaluation Criteria in Solid Tumors version 1.0 (mRECIST) for mesothelioma that was previously untreated with systemic therapy. All histological subtypes were eligible. The first six participants were treated for two cycles in a safety run-in. All participants received cisplatin 75 mg/m 2 , pemetrexed 500 mg/m 2 , and durvalumab 1125 mg intravenously on day 1 of a 3-weekly schedule for a maximum of six cycles. Change from cisplatin to carboplatin with an area under the curve of 5 was permitted. Durvalumab was continued for a maximum of 12 months. The primary endpoint was progression-free survival at 6 months, measured according to mRECIST for malignant pleural mesothelioma and analysed in the intention-to-treat population. Safety analyses included all participants who receive at least one dose of any study drug. This study is registered with the Australia New Zealand Clinical Trials Registry, ACTRN12616001170415.
FINDINGS


Between Dec 28, 2016, and Sept 27, 2017, 55 participants were enrolled. 54 patients were eligible and were followed up for a median of 28·2 months (IQR 26·5-30·2). 31 (57%; 95% CI 44-70) of 54 patients were alive and progression-free at 6 months. The most common grade 3-4 adverse events were neutropenia (seven [13%] patients), nausea (six [11%]), and anaemia (four [7%]). A total of 60 serious adverse events occurred in 29 participants, five of which were considered possibly related to durvalumab. Five patients died during the study treatment; none of these five deaths were attributed to study treatment.
INTERPRETATION


The combination of durvalumab, cisplatin, and pemetrexed has promising activity and an acceptable safety profile that warrants further investigation in a randomised phase 3 trial.
FUNDING


AstraZeneca.",2020,"A total of 60 serious adverse events occurred in 29 participants, five of which were considered possibly related to durvalumab.","['patients with advanced malignant pleural mesothelioma', 'nine hospitals in Australia', 'participants who receive at least one dose of any study drug', 'Eligible patients were aged 18 years or older and had histologically confirmed malignant pleural mesothelioma considered unsuitable for cancer-directed surgery, an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease as per the modified Response Evaluation Criteria in Solid Tumors version 1.0 (mRECIST) for mesothelioma that was previously untreated with systemic therapy', '54 patients were eligible and were followed up for a median of 28·2 months (IQR 26·5-30·2', 'previously untreated malignant pleural mesothelioma (DREAM', 'Between Dec 28, 2016, and Sept 27, 2017, 55 participants were enrolled']","['cisplatin to carboplatin', 'cisplatin and pemetrexed', 'cisplatin 75 mg/m 2 , pemetrexed 500 mg/m 2 , and durvalumab', 'Chemotherapy with cisplatin and pemetrexed', 'durvalumab, cisplatin, and pemetrexed', 'Durvalumab with first-line chemotherapy']","['nausea', 'alive and progression-free', 'neutropenia', 'anaemia', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854889', 'cui_str': 'Pleural mesothelioma malignant advanced'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013117', 'cui_str': 'Dream'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",55.0,0.245365,"A total of 60 serious adverse events occurred in 29 participants, five of which were considered possibly related to durvalumab.","[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'Sir Charles Gairdner Hospital, Nedlands, WA, Australia; National Centre for Asbestos Related Diseases, Perth, WA, Australia; Medical School, University of Western Australia, Perth, WA, Australia. Electronic address: anna.nowak@uwa.edu.au.'}, {'ForeName': 'W Joost', 'Initials': 'WJ', 'LastName': 'Lesterhuis', 'Affiliation': 'National Centre for Asbestos Related Diseases, Perth, WA, Australia; School of Biomedical Sciences, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Peey-Sei', 'Initials': 'PS', 'LastName': 'Kok', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Brett Gm', 'Initials': 'BG', 'LastName': 'Hughes', 'Affiliation': 'The Prince Charles Hospital and University of Queensland, Brisbane, QLD, Australia; University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Deme J', 'Initials': 'DJ', 'LastName': 'Karikios', 'Affiliation': 'Nepean Hospital, Kingswood, NSW, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Austin Hospital, Heidelberg, VIC, Australia.'}, {'ForeName': 'Steven C-H', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Connull', 'Initials': 'C', 'LastName': 'Leslie', 'Affiliation': 'PathWest Laboratory Medicine, Nedlands, WA, Australia.'}, {'ForeName': 'Alistair M', 'Initials': 'AM', 'LastName': 'Cook', 'Affiliation': 'National Centre for Asbestos Related Diseases, Perth, WA, Australia; Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Royal North Shore Hospital and Northern Cancer Institute, Sydney, NSW, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Briscoe', 'Affiliation': 'Mid North Coast Cancer Institute, Coffs Harbour Health Campus, Coffs Harbour, NSW, Australia.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': ""O'Byrne"", 'Affiliation': 'Princess Alexandra Hospital and Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'Flinders Medical Centre and Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Wei-Sen', 'Initials': 'WS', 'LastName': 'Lam', 'Affiliation': 'Department of Medical Oncology, Fiona Stanley Hospital and Western Australia Country Health Service, Perth, WA, Australia.'}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Langford', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Yip', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30462-9']
2046,32888454,"Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial.","BACKGROUND


Topotecan is currently the only drug approved in Europe in a second-line setting for the treatment of small-cell lung cancer. This study investigated whether the doublet of carboplatin plus etoposide was superior to topotecan as a second-line treatment in patients with sensitive relapsed small-cell lung cancer.
METHODS


In this open-label, randomised, phase 3 trial done in 38 hospitals in France, we enrolled patients with histologically or cytologically confirmed advanced stage IV or locally relapsed small-cell lung cancer, who responded to first-line platinum plus etoposide treatment, but who had disease relapse or progression at least 90 days after completion of first-line treatment. Eligible patients were aged 18 years or older and had an Eastern Cooperative Oncology Group performance status 0-2. Enrolled patients were randomly assigned (1:1) to receive combination carboplatin plus etoposide (six cycles of intravenous carboplatin [area under the curve 5 mg/mL per min] on day 1 plus intravenous etoposide [100 mg/m 2  from day 1 to day 3]) or oral topotecan (2·3 mg/m 2  from day 1 to day 5, for six cycles). Randomisation was done using the minimisation method with biased-coin balancing for ECOG performance status, response to the first-line chemotherapy, and treatment centre. The primary endpoint was progression-free survival, which was centrally reviewed and analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02738346.
FINDINGS


Between July 18, 2013, and July 2, 2018, we enrolled and randomly assigned 164 patients (82 in each study group). One patient from each group withdrew consent, therefore 162 patients (81 in each group) were included in the intention-to-treat population. With a median follow-up of 22·7 months (IQR 20·0-37·3), median progression-free survival was significantly longer in the combination chemotherapy group than in the topotecan group (4·7 months, 90% CI 3·9-5·5 vs 2·7 months, 2·3-3·2; stratified hazard ratio 0·57, 90% CI 0·41-0·73; p=0·0041). The most frequent grade 3-4 adverse events were neutropenia (18 [22%] of 81 patients in the topotecan group vs 11 [14%] of 81 patients in the combination chemotherapy group), thrombocytopenia (29 [36%] vs 25 [31%]), anaemia (17 [21%] vs 20 [25%]), febrile neutropenia (nine [11%] vs five [6%]), and asthenia (eight [10%] vs seven [9%]). Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
INTERPRETATION


Our results suggest that carboplatin plus etoposide rechallenge can be considered as a reasonable second-line chemotherapy option for patients with sensitive relapsed small-cell lung cancer.
FUNDING


Amgen and the French Lung Cancer Group (Groupe Français de Pneumo-Cancérologie).",2020,"Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
","['Between July 18, 2013, and July 2, 2018, we enrolled and randomly assigned 164 patients (82 in each study group', 'patients with sensitive relapsed small-cell lung cancer', '162 patients (81 in each group) were included in the intention-to-treat population', '38 hospitals in France, we enrolled patients with histologically or cytologically confirmed advanced stage IV or locally relapsed small-cell lung cancer, who responded to first-line platinum plus etoposide treatment, but who had disease relapse or progression at least 90 days after completion of first-line treatment', 'Eligible patients were aged 18 years or older and had an Eastern Cooperative Oncology Group performance status 0-2']","['carboplatin plus etoposide', 'oral topotecan', 'Carboplatin plus etoposide versus topotecan', 'combination carboplatin plus etoposide (six cycles of intravenous carboplatin [area under the curve 5 mg/mL per min] on day 1 plus intravenous etoposide']","['febrile neutropenia', 'thrombocytopenia', 'asthenia', 'deaths', 'neutropenia', 'median progression-free survival', 'anaemia', 'progression-free survival', 'febrile neutropenia with sepsis']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",164.0,0.170259,"Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Baize', 'Affiliation': ""Service de Cancérologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Aix-Marseille University, Marseille, France; Department of Multidisciplinary Oncology and Therapeutic Innovations, APHM, Hôpital Nord, Marseille, France; Department of Multidisciplinary Oncology and Therapeutic Innovations, Hôpital Nord, Marseille, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Geier', 'Affiliation': 'Service de Pneumologie, CHU Brest, Brest, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lena', 'Affiliation': 'Service de Pneumologie, CHU Rennes, Rennes, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Janicot', 'Affiliation': 'Service de Pneumologie, CHU Clermont-Ferrand, Clermont Ferrand, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vergnenegre', 'Affiliation': 'Service de Pneumologie, CHU Limoges, Limoges, France.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Crequit', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Beauvais, Beauvais, France.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Lamy', 'Affiliation': 'Service de Pneumologie, CH Bretagne Sud, Lorient, France.'}, {'ForeName': 'Jean-Bernard', 'Initials': 'JB', 'LastName': 'Auliac', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Letreut', 'Affiliation': 'Service de Pneumologie, Hôpital Européen, Marseille, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Caer', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Saint Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Radj', 'Initials': 'R', 'LastName': 'Gervais', 'Affiliation': ""Service d'Oncologie, Centre François Baclesse, Caen, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dansin', 'Affiliation': ""Service d'Oncologie, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Madroszyk', 'Affiliation': ""Service d'Oncologie, Institut Paoli-Calmettes, Marseille, France.""}, {'ForeName': 'Patrick-Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Pau, Pau, France.'}, {'ForeName': 'Gwenaëlle', 'Initials': 'G', 'LastName': 'Le Garff', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Saint Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Falchero', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Villefranche de Rouergue, Villefranche, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Berard', 'Affiliation': ""Service de Pneumologie, Hôpital d'instruction des armées Sainte-Anne, Toulon, France.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Schott', 'Affiliation': ""Service d'Oncologie, Centre Paul Strauss, Strasbourg, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Saulnier', 'Affiliation': ""Département de Biostatistiques et Méthodologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Chouaid', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France; Institut Mondor de Recherche Biomédicale, U955 Inserm-Université Paris Est Créteil, Créteil, France. Electronic address: christos.chouaid@chicreteil.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30461-7']
2047,32889373,Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS.,"BACKGROUND


Fingolimod lowers the number of relapses in multiple sclerosis (MS) patients and slows down disease progression, but causes a broad spectrum of side effects. Our aim was to estimate the benefit-harm balance of fingolimod using individual patient data from FREEDOMS, a randomized controlled trial that compared two different dosages of fingolimod to placebo.
METHODS


We modelled the health status of patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health). The model considered Expanded Disability Status Scale measurements, relapses and adverse events. We compared the mean health status between arms, and the proportion of trial participants for whom health declined or improved compared to baseline by a predefined minimal important difference of 4.6 or more.
RESULTS


The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2). Patients on fingolimod 0.5mg were 0.53 (95% CI 0.40-0.72, p<0.001) times less likely to have a relevant decline in health status compared to patients on placebo, corresponding to a number needed to treat of 8 to prevent one relevant decline in health status. All sensitivity analyses favoured fingolimod 0.5mg.
CONCLUSION


Although fingolimod's net benefit did not reach the clinical relevance on average, the decreased risk for a decline in health over two years may be relevant. This approach could be applied to other MS drugs and provide an objective evidence base for guideline recommendations.",2020,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","['patients with MS', 'patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health']","['placebo', 'fingolimod to placebo']","['mean health status', 'Disability Status Scale measurements, relapses and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143984,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Spanu', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Hélène E', 'Initials': 'HE', 'LastName': 'Aschmann', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Kesselring', 'Affiliation': 'RehaKliniken Valens, Zurich, Switzerland.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland. Electronic address: miloalan.puhan@uzh.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102464']
2048,32889413,Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial.,"STUDY OBJECTIVE


To investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity.
DESIGN


This was a prospective, randomized, controlled study.
SETTING


The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018.
PATIENTS


146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled.
INTERVENTION


Patients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO 2 ) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45-60 before and after CPB and 40-45 during CPB.
MEASUREMENTS


The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications.
MAIN RESULTS


128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19-5.31; P < 0.001).
CONCLUSIONS


In high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.",2020,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","['high-risk surgical patients', 'high-risk patients undergoing cardiac surgery', 'The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018', '146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled']","['individualized goal-directed therapy', 'cardiac surgery, individualized GDT therapy', 'individualized goal-directed therapy (GDT', 'individualized GDT group or usual care group']","['mean arterial pressure (MAP', 'Early morbidity', 'morbidity', 'cerebral oxygen balance', 'regional cerebral oxygen saturation (rScO 2 ) level', 'bispectral index (BIS', 'composite endpoint of 30-day mortality and major postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.315518,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","[{'ForeName': 'Xin-Qi', 'Initials': 'XQ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_mz_cheng@126.com.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacology, Anhui Medical University, 230032 Hefei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'You-Mei', 'Initials': 'YM', 'LastName': 'Zuo', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Er-Wei', 'Initials': 'EW', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_guew_mz@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110032']
2049,32886650,Assessing the validity and reliability and determining cut-points of the Actiwatch 2 in measuring physical activity.,"OBJECTIVE


The Actiwatch 2 (AW2) is a wrist-worn accelerometer typically used to measure sleep. Although it can measure physical activity, there is limited evidence supporting its validity. We assessed the validity and reliability of the AW2 to measure sedentary behavior and physical activity (light, moderate, vigorous intensities), and reported their respective count cut-points.
APPROACH


Twenty-eight males and 22 females completed a task battery comprising three sedentary tasks and six randomized physical activity tasks at varying intensities, whilst wearing the AW2, a reference accelerometry device (Actigraph GT3X) and a cardiopulmonary gas analyzer on two separate occasions. Validity was assessed using correlations (AW2 counts versus GT3X counts and metabolic equivalent (MET) values), reliability using Bland-Altman analyses, and cut-points were determined using receiver operating characteristic (ROC) area under the curve (AUC) analyses.
MAIN RESULTS


AW2 counts were positively correlated with GT3X counts (rho = 0.902, p < 0.001) and METs (rho = 0.900, p < 0.001). AW2-derived counts were comparable across independent assessment periods. Sedentary (AUC = 0.99, cut-point: 256 cpm) and vigorous activity (AUC = 0.95, cut-point: 720 cpm) were strongly characterized, and moderate activity (AUC = 0.66, cut-point: 418 cpm) was weakly characterized.
SIGNIFICANCE


The use of the AW2 in physical activity monitoring looks promising for sedentary behavior, moderate and vigorous activity, however, further validation is needed.",2020,"MAIN RESULTS


AW2 counts were positively correlated with GT3X counts (rho = 0.902, p < 0.001) and METs (rho = 0.900, p < 0.001).",['Twenty-eight males and 22 females completed a'],"['task battery comprising three sedentary tasks and six randomized physical activity tasks at varying intensities, whilst wearing the AW2, a reference accelerometry device (Actigraph GT3X']","['validity and reliability of the AW2 to measure sedentary behavior and physical activity (light, moderate, vigorous intensities', 'correlations (AW2 counts versus GT3X counts and metabolic equivalent (MET) values), reliability using Bland-Altman analyses, and cut-points', 'receiver operating characteristic (ROC) area under the curve (AUC) analyses', 'AW2-derived counts', 'GT3X counts']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",3.0,0.0213622,"MAIN RESULTS


AW2 counts were positively correlated with GT3X counts (rho = 0.902, p < 0.001) and METs (rho = 0.900, p < 0.001).","[{'ForeName': 'Chadley', 'Initials': 'C', 'LastName': 'Kemp', 'Affiliation': 'Health through Physical Activity, Lifestyle and Sport Research Centre & Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, South Africa.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Pienaar', 'Affiliation': ''}, {'ForeName': 'Rob H P', 'Initials': 'RHP', 'LastName': 'Henst', 'Affiliation': ''}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Roden', 'Affiliation': ''}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Kolbe-Alexander', 'Affiliation': ''}, {'ForeName': 'Dale E', 'Initials': 'DE', 'LastName': 'Rae', 'Affiliation': ''}]",Physiological measurement,['10.1088/1361-6579/aba80f']
2050,32886710,Study of the efficacy of the Hero program: Cross-national evidence.,"The present study focuses on an analysis of the efficacy of the online intervention program called ""Hero"" for promoting prosociality and other socioemotional variables related to prosocial behavior, such as empathy, positive emotions, and forgiveness, in two Latin American countries: Argentina and Uruguay. The final Argentinean sample consisted of 579 adolescents (experimental group = 319 and control group = 260), and the Uruguayan sample consisted of 330 adolescents (experimental group = 140 and control group = 169), aged 12 to 15 years old. The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness. It impacted each of the dimensions comprising these variables differently depending on the country where it was applied. We discuss the differences found in each country.",2020,"The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness.","['579 adolescents (experimental group = 319 and control group = 260), and the Uruguayan sample consisted of 330 adolescents (experimental group = 140 and control group = 169), aged 12 to 15 years old']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],579.0,0.016216,"The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness.","[{'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Mesurado', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Oñate', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Putrino', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Guerra', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Vanney', 'Affiliation': 'Universidad Austral, Pilar, Argentina.'}]",PloS one,['10.1371/journal.pone.0238442']
2051,32886727,"Assessing the impact of professional lactation support frequency, duration and delivery form on exclusive breastfeeding in Lebanese mothers.","BACKGROUND


The optimal frequency, duration, and form of professional lactation support needed to continue exclusive breastfeeding (EBF) for six months have not yet been specifically identified. This study investigates the association between six-month EBF and the frequency, duration, and form (face-to-face vs. telephone contact) of professional lactation support in a cohort of Lebanese mothers, and explores barriers to EBF during the first six months postpartum.
METHODS


An observational study was nested in a breastfeeding support randomized controlled trial. Secondary analysis of data from 159 trial participants who received professional lactation support was conducted. (1) Six-month EBF with professional lactation support frequency, duration, and form was investigated using bivariate and multivariate regression analyses. (2) Barriers to breastfeeding were explored using content analysis of narrative data collected about breastfeeding mothers by the lactation experts.
RESULTS


Six-month EBF was achieved by 57/159 (35.8%) participants. Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001). In crude analysis, those mothers had a higher number of overall contacts with lactation experts (mean ± SD of 9.5 ± 2.9 vs. 7.0 ± 4.4, p = 0.001), and longer duration of face-to-face contacts (mean ± SD of 261.9 ± 209.1 vs. 201.0 ± 117.4 minutes, p = 0.035). In adjusted analysis, frequencies of overall and of telephone contacts with the lactation experts were positively associated with six-month EBF (OR = 1.15; 95% CI: 1.04 to 1.27, p = 0.007; OR = 1.12; 95% CI: 1.00 to 1.26, p = 0.05; respectively). Participants discontinuing EBF early were described as inexperienced, lacking breastfeeding knowledge, concerned about milk insufficiency, and showing negative attitudes towards night feeds.
CONCLUSION


Need-based telephone contact augmenting face-to-face professional lactation support may positively influence six-month EBF. Early identification of mothers at risk for early discontinuation of EBF can help tailor interventions specific to their concerns.",2020,"Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001).","['159 trial participants who received professional lactation support was conducted', 'Lebanese mothers']",['EBF'],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",[],,0.0567391,"Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001).","[{'ForeName': 'Dayane', 'Initials': 'D', 'LastName': 'Daou', 'Affiliation': 'Department of Anesthesiology, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Tamim', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine, Clinical Research Institute, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nabulsi', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, American University of Beirut, Beirut, Lebanon.'}]",PloS one,['10.1371/journal.pone.0238735']
2052,32890813,CONKO-006: A randomised double-blinded phase IIb-study of additive therapy with gemcitabine + sorafenib/placebo in patients with R1 resection of pancreatic cancer - Final results.,"BACKGROUND


CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles.
PATIENTS AND METHODS


This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment.
RESULTS


122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
CONCLUSION


CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients.
CLINICAL TRIAL INFORMATION


German Tumor Study Registry (Deutsches Krebsstudienregister), DRKS00000242.",2020,"Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
","['patients with R1 resection of pancreatic cancer - Final results', '122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP', 'German Tumor Study Registry', 'patients with pancreatic adenocarcinoma with postsurgical R1 residual status']","['gemcitabine + sorafenib/placebo', 'gemcitabine\xa0+\xa0placebo (GemP', 'gemcitabine and sorafenib (GemSorafenib', 'Sorafenib', 'placebo', 'gemcitabine']","['recurrence-free survival (RFS', 'thrombocytopenia', 'hypertension', 'RFS nor OS', 'survival', 'fatigue', 'RFS (median GemSorafenib', 'neutropenia', 'longer OS', 'nodal positivity', 'overall survival (OS), safety and duration of treatment', 'Grade 3/4 toxicities comprised diarrhoea', 'elevated gamma-glutamyl transferase (GGT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",122.0,0.424538,"Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany; Universitätsklinikum Hamburg-Eppendorf, Department of Medical Oncology, Hamburg, Germany. Electronic address: ma.sinn@uke.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Liersch', 'Affiliation': 'University of Göttingen, Department of General, Visceral and Pediatric Surgery, Göttingen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gellert', 'Affiliation': 'Sana Klinikum Lichtenberg, Department of General and Visceral Surgery, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stübs', 'Affiliation': 'Otto-Guericke-University of Magdeburg, Department of General, Visceral and Vascular Surgery, Magdeburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Waldschmidt', 'Affiliation': 'University of Köln, Department of Gastroenterology and Hepatology, Köln, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lammert', 'Affiliation': 'Universitätskliniken des Saarlandes, Department of Internal Medicine, Gastroenterology and Endocrinology, Homburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Ernst von Bergmann Klinikum, Department of Hematology, Oncology and Palliative Care, Potsdam, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bechstein', 'Affiliation': 'Universitätsklinikum Frankfurt, Department of General and Visceral Surgery, Frankfurt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bitzer', 'Affiliation': 'Eberhard-Karls-Universität Tübingen, Department of Internal Medicine, Tübingen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': 'Marienhospital Stuttgart, Department of Hematology, Oncology and Palliative Care, Stuttgart Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hofheinz', 'Affiliation': 'Universitätsklinikum Mannheim, Department of Medical Oncology, Mannheim, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lindig', 'Affiliation': 'Universitätsklinikum Jena, Department of Hematology and Oncology, Jena, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'University of Göttingen, Department of General, Visceral and Pediatric Surgery, Göttingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hinke', 'Affiliation': 'CCRC, Düsseldorf, Germany.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Striefler', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bischoff', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahra', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Surgery, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oettle', 'Affiliation': 'Outpatient Department of Hematology/Oncology, Friedrichshafen, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.032']
2053,32890969,Effect of high-intensity interval training on cardiac structure and function in rats with acute myocardial infarct.,"BACKGROUND


Exercise training is beneficial for cardiac rehabilitation. Nevertheless, few study focused on the role of high-intensity interval training (HIIT) in cardiac repair. The current study aimed to elucidate the effect of HIIT on cardiac rehabilitation and the involved mechanisms after acute myocardial infarction (MI).
METHODS


A total of 65 male rats underwent coronary ligation or sham operation and were randomly assigned to 4 groups: sham (n = 10), sedentary (MI-Sed, n = 12), moderate-intensity continuous training (MI-MCT, n = 12) and HIIT (MI-HIIT, n = 12). One week after MI induction, adaptive training starts follow by formal training. After the experiment, cardiac functions were determined by echocardiography and hemodynamic measurements. Changes in infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system (RAAS) activities were measured. Data were analyzed by one-way ANOVA.
RESULTS


After MI, cardiac structure and function were significantly deteriorated. However, post-MI HIIT for 8 weeks had significantly ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax). Moreover, it preserved cardiac functions, reduced infarct size, protected the myocardium structure, increased angiogenesis and decreased the myofibroblasts and collagen accumulation. HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis. Additionally, it induced inflammation response and repressed ET-1 and RAAS activities were found in myocardium and peripheral circulation after HIIT.
CONCLUSION


Our results suggested that post-MI HIIT had a positive role in cardiac repair, which might be linked with the induction of inflammation and inhibition of ET-1 and RAAS activities.",2020,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","['65 male rats underwent', 'rats with acute myocardial infarct']","['Exercise training', 'HIIT', 'coronary ligation or sham operation', 'high-intensity interval training', 'moderate-intensity continuous training']","['RAAS) activities', 'cardiac functions', 'inflammation response and repressed ET-1 and RAAS activities', 'cardiac structure and function', 'myofibroblasts and collagen accumulation', 'LVEDP, -dP/dtmax, infarct size and angiogenesis', 'ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax', 'infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0225360', 'cui_str': 'Myofibroblast'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",65.0,0.0338951,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","[{'ForeName': 'Bozhong', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Shou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tong', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Genxiang', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China. Electronic address: aaiwuqing@126.com.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110690']
2054,32891018,Effects of multimodal balance training supported by rhythmical auditory stimuli in people with advanced stages of Parkinson's disease: a pilot randomized clinical trial.,"Non-pharmacological interventions such as physiotherapy are recognized as important elements in the overall clinical management of motor impairments in PD, but evidence of physiotherapy in advanced disease stages is sparse. A recent trial found positive effects of multimodal balance training in people with mild to moderate PD, with greater and more sustained effects when rhythmical auditory stimuli were added. It is unclear whether such multimodal balance training is also effective in people with advanced PD (Hoehn & Yahr stage 4).
METHODS


We performed a pilot prospective single-blind, randomized clinical trial to study the effectiveness of multimodal training with and without rhythmical auditory stimuli. We screened 76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients were assigned randomly into two groups: (1) multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n = 17) and (2) multimodal balance training without rhythmical auditory cues (n = 18). Training was performed for 5 weeks, two times/week. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by the same two blinded assessors at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS


Immediately post-intervention, both intervention groups improved significantly on Mini-Best scores, without differences between both intervention modalities. In both groups, results were retained at one-month follow-up. At 6-months follow-up, the effects were retained only in the RAS-supported intervention group. For both intervention groups, no improvements were found on secondary outcome measures for gait.
CONCLUSION


Both RAS-supported multimodal balance training and regular multimodal balance training improve balance in PD patients in advanced disease stages. Effects appear to sustain longer in the RAS-supported training group.",2020,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","['PD patients in advanced disease stages', ""people with advanced stages of Parkinson's disease"", 'people with advanced PD (Hoehn & Yahr stage 4', 'people with mild to moderate PD', ""76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients""]","['multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n\xa0=\xa017) and (2) multimodal balance training without rhythmical auditory cues', 'multimodal balance training and regular multimodal balance training', 'multimodal balance training', 'multimodal training with and without rhythmical auditory stimuli']","['Mini-BESTest (MBEST) score', 'gait', 'Mini-Best scores', 'rhythmical auditory stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]",76.0,0.0570846,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil. Electronic address: tamine.capato@radboudumc.nl.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour; Department of Rehabilitation, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; Sint Maartenskliniek, Department of Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud University Medical Center, Department for Health Evidence, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117086']
2055,32891170,"(1,3)-β-D-Glucan-based empirical antifungal interruption in suspected invasive candidiasis: a randomized trial.","BACKGROUND


(1,3)-β-D-Glucan has been widely used in clinical practice for the diagnosis of invasive Candida infections. However, such serum biomarker showed potential to guide antimicrobial therapy in order to reduce the duration of empirical antifungal treatment in critically ill septic patients with suspected invasive candidiasis.
METHODS


This was a single-centre, randomized, open-label clinical trial in which critically ill patients were enrolled during the admission to the intensive care unit (ICU). All septic patients who presented invasive Candida infection risk factors and for whom an empirical antifungal therapy was commenced were randomly assigned (1:1) in those stopping antifungal therapy if (1,3)-β-D-glucan was negative ((1,3)-β-D-glucan group) or those continuing the antifungal therapy based on clinical rules (control group). Serum 1,3-β-D-glucan was measured at the enrolment and every 48/72 h over 14 days afterwards. The primary endpoint was the duration of antifungal treatment in the first 30 days after enrolment.
RESULTS


We randomized 108 patients into the (1,3)-β-D-glucan (n = 53) and control (n = 55) groups. Median [IQR] duration of antifungal treatment was 2 days [1-3] in the (1,3)-β-D-glucan group vs. 10 days [6-13] in the control group (between-group absolute difference in means, 6.29 days [95% CI 3.94-8.65], p < 0.001). Thirty-day mortality was similar (28.3% [(1,3)-β-D-glucan group] vs. 27.3% [control group], p = 0.92) as well as the overall rate of documented candidiasis (11.3% [(1,3)-β-D-glucan group] vs. 12.7% [control group], p = 0.94), the length of mechanical ventilation (p = 0.97) and ICU stay (p = 0.23).
CONCLUSIONS


In critically ill septic patients admitted to the ICU at risk of invasive candidiasis, a (1,3)-β-D-glucan-guided strategy could reduce the duration of empirical antifungal therapy. However, the safety of this algorithm needs to be confirmed in future, multicentre clinical trial with a larger population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03117439 , retrospectively registered on 18 April 2017.",2020,"Thirty-day mortality was similar (28.3% [(1,3)-β-D-glucan group] vs. 27.3% [control group], p = 0.92) as well as the overall rate of documented candidiasis (11.3% [(1,3)-β-D-glucan group] vs. 12.7% [control group], p = 0.94), the length of mechanical ventilation (p = 0.97) and ICU stay (p = 0.23).
","['18 April 2017', 'critically ill septic patients admitted to the ICU at risk of invasive candidiasis', '108 patients into the (1,3)-β-D-glucan (n\u2009=\u200953) and control (n\u2009=\u200955) groups', 'critically ill septic patients with suspected invasive candidiasis', 'suspected invasive candidiasis', 'critically ill patients were enrolled during the admission to the intensive care unit (ICU', 'All septic patients who presented invasive Candida infection risk factors and for whom an empirical antifungal therapy was commenced were randomly assigned (1:1) in those']","['1,3)-β-D-Glucan-based empirical antifungal interruption', 'stopping antifungal therapy if (1,3)-β-D-glucan was negative ((1,3)-β-D-glucan group) or those continuing the antifungal therapy based on clinical rules (control group']","['length of mechanical ventilation', 'Serum 1,3-β-D-glucan', 'Thirty-day mortality', 'duration of antifungal treatment', 'overall rate of documented candidiasis', 'Median [IQR] duration of antifungal treatment', 'ICU stay']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0153252', 'cui_str': 'Invasive candidiasis'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2363963', 'cui_str': 'Antifungal treatment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",108.0,0.153783,"Thirty-day mortality was similar (28.3% [(1,3)-β-D-glucan group] vs. 27.3% [control group], p = 0.92) as well as the overall rate of documented candidiasis (11.3% [(1,3)-β-D-glucan group] vs. 12.7% [control group], p = 0.94), the length of mechanical ventilation (p = 0.97) and ICU stay (p = 0.23).
","[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'De Pascale', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy. gennaro.depascalemd@gmail.com.""}, {'ForeName': 'Brunella', 'Initials': 'B', 'LastName': 'Posteraro', 'Affiliation': 'Dipartimento di Scienze Gastroenterologiche, Endocrino-Metaboliche e Nefro-Urologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': ""D'Arrigo"", 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Spinazzola', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Gaspari', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bello', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Luca Maria', 'Initials': 'LM', 'LastName': 'Montini', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Salvatore Lucio', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Domenico Luca', 'Initials': 'DL', 'LastName': 'Grieco', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Gravio', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'De Angelis', 'Affiliation': 'Università Cattolica del Sacro Cuore, Istituto di Microbiologia, Largo F. Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Torelli', 'Affiliation': 'Dipartimento di Scienze di Laboratorio e Infettivologiche, UOC di Microbiologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'De Carolis', 'Affiliation': 'Dipartimento di Scienze di Laboratorio e Infettivologiche, UOC di Microbiologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tumbarello', 'Affiliation': 'Dipartimento di Scienze di Laboratorio e Infettivologiche , UOC di Malattie Infettive, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Sanguinetti', 'Affiliation': 'Università Cattolica del Sacro Cuore, Istituto di Microbiologia, Largo F. Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Antonelli', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}]","Critical care (London, England)",['10.1186/s13054-020-03265-y']
2056,32891501,Inpatient link to peer recovery coaching: Results from a pilot randomized control trial.,"BACKGROUND


Few individuals hospitalized with Substance Use Disorder (SUD) complications participate in recovery support services after discharge. Peer recovery coaching represents one potential new method for promoting recovery.
METHODS


A six-month prospective randomized controlled trial compared outcomes between the standard of care and a physician-initiated recovery coaching intervention. The primary outcome measure was engagement in recovery support services, and the secondary outcome measures were substance use frequency and self-reported physical and mental health using the SF-12 survey. Participants (N = 98) were eligible if they were identified by a healthcare provider as having a SUD and were hospitalized due to SUD complications.
RESULTS


Engagement rate over the six-month post-discharge time period was higher for participants in the recovery coaching intervention (84 %, 95 % CI: 78%-91%) compared to the standard of care control condition (34 %, 95 % CI: 25 %-44 %), log OR = 28.59, p < .001. No overall group differences in substance use frequency (p = .80), self-reported physical (p = .69) or mental (p = .89) health were observed.
CONCLUSION


An inpatient linkage to recovery coaching services improves engagement rates and can feasibly be implemented in a single-center inpatient service. This intervention is promising for promoting both short-term and long-term engagement in recovery support services.",2020,"RESULTS


Engagement rate over the six-month post-discharge time period was higher for participants in the recovery coaching intervention (84 %, 95 % CI: 78%-91%) compared to the standard of care control condition (34 %, 95 % CI: 25 %-44 %), log OR = 28.59, p < .001.","['individuals hospitalized with Substance Use Disorder (SUD) complications participate in recovery support services after discharge', 'Participants (N = 98) were eligible if they were identified by a healthcare provider as having a SUD and were hospitalized due to SUD complications']",['standard of care and a physician-initiated recovery coaching intervention'],"['engagement in recovery support services', 'substance use frequency and self-reported physical and mental health using the SF-12 survey', 'discharge time period', 'substance use frequency']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}]",98.0,0.200801,"RESULTS


Engagement rate over the six-month post-discharge time period was higher for participants in the recovery coaching intervention (84 %, 95 % CI: 78%-91%) compared to the standard of care control condition (34 %, 95 % CI: 25 %-44 %), log OR = 28.59, p < .001.","[{'ForeName': 'Kaileigh A', 'Initials': 'KA', 'LastName': 'Byrne', 'Affiliation': 'Clemson University, United States. Electronic address: kaileib@clemson.edu.'}, {'ForeName': 'Prerana J', 'Initials': 'PJ', 'LastName': 'Roth', 'Affiliation': 'Prisma Health-Upstate, United States; University of South Carolina School of Medicine - Greenville, United States.'}, {'ForeName': 'Krupa', 'Initials': 'K', 'LastName': 'Merchant', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Bryana', 'Initials': 'B', 'LastName': 'Baginski', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Robinson', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Dumas', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Collie', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ramsey', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Cull', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Cooper', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Churitch', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Rennert', 'Affiliation': 'Clemson University, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Clemson University, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'FAVOR-Greenville, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108234']
2057,32893710,"Effects of a Vegetarian Diet on Cardiometabolic Risk Factors, Gut Microbiota, and Plasma Metabolome in Subjects With Ischemic Heart Disease: A Randomized, Crossover Study.","Background A vegetarian diet (VD) may reduce future cardiovascular risk in patients with ischemic heart disease. Methods and Results A randomized crossover study was conducted in subjects with ischemic heart disease, assigned to 4-week intervention periods of isocaloric VD and meat diet (MD) with individually designed diet plans, separated by a 4-week washout period. The primary outcome was difference in oxidized low-density lipoprotein cholesterol (LDL-C) between diets. Secondary outcomes were differences in cardiometabolic risk factors, quality of life, gut microbiota, fecal short-chain and branched-chain fatty acids, and plasma metabolome. Of 150 eligible patients, 31 (21%) agreed to participate, and 27 (87%) participants completed the study. Mean oxidized LDL-C (-2.73 U/L), total cholesterol (-5.03 mg/dL), LDL-C (-3.87 mg/dL), and body weight (-0.67 kg) were significantly lower with the VD than with the MD. Differences between VD and MD were observed in the relative abundance of several microbe genera within the families Ruminococcaceae, Lachnospiraceae, and Akkermansiaceae. Plasma metabolites, including l-carnitine, acylcarnitine metabolites, and phospholipids, differed in subjects consuming VD and MD. The effect on oxidized LDL-C in response to the VD was associated with a baseline gut microbiota composition dominated by several genera of Ruminococcaceae. Conclusions The VD in conjunction with optimal medical therapy reduced levels of oxidized LDL-C, improved cardiometabolic risk factors, and altered the relative abundance of gut microbes and plasma metabolites in patients with ischemic heart disease. Our results suggest that composition of the gut microbiota at baseline may be related to the reduction of oxidized LDL-C observed with the VD. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02942628.",2020,"Differences between VD and MD were observed in the relative abundance of several microbe genera within the families Ruminococcaceae, Lachnospiraceae, and Akkermansiaceae.","['subjects with ischemic heart disease', 'patients with ischemic heart disease', '150 eligible patients, 31 (21%) agreed to participate, and 27 (87%) participants completed the study', 'Subjects With Ischemic Heart Disease']","['isocaloric VD and meat diet (MD) with individually designed diet plans', 'Vegetarian Diet', ' A vegetarian diet (VD', 'Registration URL']","['oxidized LDL-C, improved cardiometabolic risk factors', 'Mean oxidized LDL-C (-2.73\xa0U/L), total cholesterol', 'body weight', 'cardiometabolic risk factors, quality of life, gut microbiota, fecal short-chain and branched-chain fatty acids, and plasma metabolome', 'oxidized low-density lipoprotein cholesterol (LDL-C', 'Plasma metabolites, including l-carnitine, acylcarnitine metabolites, and phospholipids', 'relative abundance of gut microbes and plasma metabolites', 'Cardiometabolic Risk Factors, Gut Microbiota, and Plasma Metabolome']","[{'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C4517637', 'cui_str': '2.73'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0596221', 'cui_str': 'Branched chain fatty acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]",150.0,0.0255706,"Differences between VD and MD were observed in the relative abundance of several microbe genera within the families Ruminococcaceae, Lachnospiraceae, and Akkermansiaceae.","[{'ForeName': 'Demir', 'Initials': 'D', 'LastName': 'Djekic', 'Affiliation': 'Department of Cardiology, Faculty of Health Örebro University Hospital Örebro Sweden.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""Engineering and Nutritional Science Shaanxi Normal University Xi'an China.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Brolin', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine University of Gothenburg Sweden.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Carlsson', 'Affiliation': 'Chalmers University of Technology Gothenburg Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Särnqvist', 'Affiliation': 'Department of Cardiology, Faculty of Health Örebro University Hospital Örebro Sweden.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Savolainen', 'Affiliation': 'Chalmers University of Technology Gothenburg Sweden.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Epidemiology and Biostatistics, School of Medical Sciences Örebro University Örebro Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Bäckhed', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine University of Gothenburg Sweden.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Tremaroli', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine University of Gothenburg Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Chalmers University of Technology Gothenburg Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Frøbert', 'Affiliation': 'Department of Cardiology, Faculty of Health Örebro University Hospital Örebro Sweden.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016518']
2058,32893717,Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial.,"Background Early reduction in albuminuria with an SGLT2 (sodium-glucose cotransporter 2) inhibitor may be a positive indicator of long-term cardiovascular and renal benefits. We assessed changes in albuminuria during the first 12 weeks of treatment and subsequent long-term cardiovascular and renal risks associated with the SGLT2 inhibitor, empagliflozin, in the EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 diabetes Mellitus Patients) trial. Methods and Results We calculated the percentage urinary albumin creatinine ratio (UACR) change from baseline to week 12 in 6820 participants who did not experience a cardiovascular outcome (including 3-point major cardiovascular events and cardiovascular death or hospitalization for heart failure) or renal outcome (defined as 40% decline in estimated glomerular filtration rate from baseline, estimated glomerular filtration rate <15 mL/min per 1.73 m 2 , need for continuous renal-replacement therapy, or renal death) during the first 12 weeks. Multivariable Cox regression models were used to estimate the hazard ratio (HR) for each 30% reduction in UACR with outcomes. Empagliflozin reduced UACR by 18% (95% CI, 14-22) at week 12 compared with placebo, and increased the likelihood of a >30% reduction in UACR (odds ratio, 1.42; 95% CI, 1.27-1.58;  P <0.001). During 3.0 years of follow-up, 704 major cardiovascular events, 440 cardiovascular deaths/hospitalizations for heart failure, and 168 renal outcomes were observed. Each 30% decrease in UACR during the first 12 weeks was statistically significantly associated with a lower hazard for major cardiovascular events (HR, 0.96; 95% CI, 0.93-0.99;  P =0.012), cardiovascular deaths/hospitalizations for heart failure (HR, 0.94; 95% CI, 0.91-0.98;  P =0.003), and renal outcomes (HR, 0.83; 95% CI, 0.78-0.89;  P <0.001). Conclusions Short-term reduction in UACR was more common with empagliflozin and was statistically significantly associated with a decreased risk of long-term cardiovascular and renal outcomes. Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01131676.",2020,"Empagliflozin reduced UACR by 18% (95% CI, 14-22) at week 12 compared with placebo, and increased the likelihood of a >30% reduction in UACR (odds ratio, 1.42; 95% CI, 1.27-1.58;  P <0.001).","['Type 2 Diabetes Mellitus', 'Type 2 diabetes Mellitus Patients) trial', '6820 participants who did not experience a cardiovascular outcome (including 3-point major cardiovascular events and cardiovascular death or hospitalization for heart failure) or renal outcome (defined as 40% decline in estimated glomerular filtration rate from baseline, estimated glomerular filtration rate <15\xa0mL/min per 1.73\xa0m 2 , need for continuous renal-replacement therapy, or renal death) during the first 12\xa0weeks']","['Empagliflozin', 'placebo', 'empagliflozin', 'SGLT2 inhibitor, empagliflozin']","['Albuminuria and Risk of Cardiovascular and Renal Outcomes', 'percentage urinary albumin creatinine ratio (UACR) change', 'major cardiovascular events', 'cardiovascular deaths/hospitalizations for heart failure', 'UACR', 'risk of long-term cardiovascular and renal outcomes', 'renal outcomes', '704 major cardiovascular events, 440 cardiovascular deaths/hospitalizations for heart failure, and 168 renal outcomes']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C4319556', 'cui_str': '168'}]",6820.0,0.255298,"Empagliflozin reduced UACR by 18% (95% CI, 14-22) at week 12 compared with placebo, and increased the likelihood of a >30% reduction in UACR (odds ratio, 1.42; 95% CI, 1.27-1.58;  P <0.001).","[{'ForeName': 'Simke W', 'Initials': 'SW', 'LastName': 'Waijer', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology Yale University School of Medicine New Haven CT.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research InstituteMt Sinai HospitalUniversity of Toronto Ontario Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Boehringer Ingelheim International GmbH Ingelheim Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Germany.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH Ingelheim Germany.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Inker', 'Affiliation': 'Tufts University School of MedicineTufts Medical Center Boston MA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine Division of Nephrology Würzburg University Clinic Würzburg Germany.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Center Groningen Groningen the Netherlands.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016976']
2059,32894044,"Effects of continuous infusion of phenylephrine vs. norepinephrine on parturients and fetuses under LiDCOrapid monitoring: a randomized, double-blind, placebo-controlled study.","BACKGROUND


Hypotension following spinal anesthesia (SA) during cesarean delivery (CD) occurs commonly and is related with maternal and fetal complications. Norepinephrine infusion is increasingly used for prevention of post-SA hypotension; however, its effects as compared to the traditional phenylephrine infusion remain unclear. This study aimed to compare the effects of phenylephrine and norepinephrine administered as continuous infusion during elective CD on maternal hemodynamic parameters and maternal and fetal outcomes.
METHODS


This prospective, single-center, randomized, controlled study included 238 consecutive term parturients who underwent CD from February 2019 to October 2019. They were randomized to receive continuous infusion of 0.25 μg/kg/min phenylephrine, 0.05 μg/kg/min norepinephrine, or placebo. Hemodynamic monitoring was performed at 10 time points using LiDCOrapid. We analyzed umbilical vein (UV), umbilical artery (UA), and peripheral vein (PV) blood gas indexes and recorded intraoperative complications.
RESULTS


In phenylephrine group, the systolic blood pressure (SBP) remain during the whole operation. Compared to the control group, phenylephrine, but not norepinephrine, significantly increased the systemic vascular resistance (SVR) to counteract the SA-induced vasodilatation, 3 min following norepinephrine/phenylephrine/LR administration (T4): 957.4 ± 590.3 vs 590.1 ± 273.7 (P < 0.000001); 5 min following norepinephrine/phenylephrine/LR administration (T5): 1104 ± 468.0 vs 789.4 ± 376.2 (P = 0.000002). at the time of incision (T6): 1084 ± 524.8 vs 825.2 ± 428.6 (P = 0.000188). Parturients in the phenylephrine group had significantly lower UV (1.91 ± 0.43) (P = 0.0003) and UA (2.05 ± 0.61) (P = 0.0038) lactate level compared to controls. Moreover, the UV pH value was higher in the phenylephrine than in the control group7.37 ± 0.03(P = 0.0013). Parturients had lower incidence of nausea, tachycardia, hypotension in phenylephrine group.
CONCLUSIONS


In this dataset, continuous phenylephrine infusion reduced the incidence of SA-induced hypotension, ameliorated SVR, while decreasing overall maternal complications. Phenylephrine infusions are considered the better choice during CD because of the significant benefit to the fetus.
TRIAL REGISTRATION


Clinicaltrial.gov Registry, NCT03833895 , Registered on 1 February 2019.",2020,Parturients in the phenylephrine group had significantly lower UV (1.91 ± 0.43) (P = 0.0003) and UA (2.05 ± 0.61),"['parturients and fetuses under LiDCOrapid monitoring', '238 consecutive term parturients who underwent CD from February 2019 to October 2019']","['phenylephrine and norepinephrine', 'norepinephrine/phenylephrine', 'placebo', 'phenylephrine vs. norepinephrine', 'continuous infusion of 0.25\u2009μg/kg/min phenylephrine, 0.05\u2009μg/kg/min norepinephrine, or placebo', 'phenylephrine', 'Phenylephrine', 'spinal anesthesia (SA', 'Norepinephrine']","['nausea, tachycardia, hypotension', 'overall maternal complications', 'incidence of SA-induced hypotension, ameliorated SVR', 'lactate level', 'umbilical vein (UV), umbilical artery (UA), and peripheral vein (PV) blood gas indexes and recorded intraoperative complications', 'systolic blood pressure (SBP', 'UV pH value', 'maternal hemodynamic parameters and maternal and fetal outcomes', 'lower UV', 'systemic vascular resistance (SVR']","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0041637', 'cui_str': 'Structure of umbilical vein'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",238.0,0.247746,Parturients in the phenylephrine group had significantly lower UV (1.91 ± 0.43) (P = 0.0003) and UA (2.05 ± 0.61),"[{'ForeName': 'Kunpeng', 'Initials': 'K', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Xuexin', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Shanxi provincial People's Hospital, Taiyuan, 030000, Shanxi, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Fengying', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Tianlong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China. w_tl5595@hotmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01145-0']
2060,32894073,First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial.,"BACKGROUND


In recent years it has become clear that fetal anomalies can already be detected at the end of the first trimester of pregnancy by two-dimensional (2D) ultrasound. This is why increasingly in developed countries the first trimester anomaly scan is being offered as part of standard care. We have developed a Virtual Reality (VR) approach to improve the diagnostic abilities of 2D ultrasound. Three-dimensional (3D) ultrasound datasets are used in VR assessment, enabling real depth perception and unique interaction. The aim of this study is to investigate whether first trimester 3D VR ultrasound is of additional value in terms of diagnostic accuracy for the detection of fetal anomalies. Health-related quality of life, cost-effectiveness and also the perspective of both patient and ultrasonographer on the 3D VR modality will be studied.
METHODS


Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion. This is a randomized controlled trial with two intervention arms. The control group receives 'care as usual': a second trimester 2D advanced ultrasound examination. The intervention group will undergo an additional first trimester 2D and 3D VR ultrasound examination. Following each examination participants will fill in validated questionnaires evaluating their quality of life and healthcare related expenses. Participants' and ultrasonographers' perspectives on the 3D VR ultrasound will be surveyed. The primary outcome will be the detection of fetal anomalies. The additional first trimester 3D VR ultrasound examination will be compared to 'care as usual'. Neonatal or histopathological examinations are considered the gold standard for the detection of congenital anomalies. To reach statistical significance and 80% power with a detection rate of 65% for second trimester ultrasound examination and 70% for the combined detection of first trimester 3D VR and second trimester ultrasound examination, a sample size of 2800 participants is needed.
DISCUSSION


First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations. Results of this study will provide policymakers and healthcare professionals with the highest level of evidence for cost-effectiveness of first trimester ultrasound using a 3D VR approach.
TRIAL REGISTRATION


Dutch Trial Registration number NTR6309 , date of registration 26 January 2017.",2020,First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations.,['Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion'],"[""care as usual': a second trimester 2D advanced ultrasound examination""]","['Health-related quality of life, cost-effectiveness', 'detection of fetal anomalies']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0032980', 'cui_str': 'Second trimester pregnancy'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",2800.0,0.142923,First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations.,"[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Pietersma', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'A G M G J', 'Initials': 'AGMGJ', 'LastName': 'Mulders', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Moolenaar', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'M G M', 'Initials': 'MGM', 'LastName': 'Hunink', 'Affiliation': 'Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'A H J', 'Initials': 'AHJ', 'LastName': 'Koning', 'Affiliation': 'Department of Pathology, Clinical Bioinformatics Unit, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'A T J I', 'Initials': 'ATJI', 'LastName': 'Go', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'E A P', 'Initials': 'EAP', 'LastName': 'Steegers', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rousian', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands. m.rousian@erasmusmc.nl.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03180-8']
2061,32894074,Effect of nipple shield use on milk removal: a mechanistic study.,"BACKGROUND


Concerns about reduced milk transfer with nipple shield (NS) use are based on evidence from studies with methodological flaws. Milk removal during breastfeeding can be impacted by infant and maternal factors other than NS use. The aim of this study was to control electric breast pump vacuum strength, pattern and duration across multiple study sessions to determine if NS use reduces milk removal from the breast.
METHODS


A within-subject study with two groups of breastfeeding mothers (infants < 6 months) were recruited; Control Group (CG): no breastfeeding difficulties; Pain Group (PG) used NS for persistent nipple pain. Mothers completed three randomised 15 min pumping sessions using the Symphony vacuum curve (Medela AG); no NS, fitted NS, and a small NS. Sessions were considered valid where the applied vacuum was within 20 mmHg of the set vacuum. Milk removal was considered as pumped milk volume, and also percentage of available milk removed (PAMR), which is calculated as the pumped volume divided by the estimated milk volume stored in the breast immediately prior to pumping.
RESULTS


Of 62 sessions (all: n = 31 paired sessions) a total of 11 paired sessions from both PG (n = 03) and CG (n = 08) were valid (subset) with and without a fitted NS. Only 2 small shield sessions were valid and so all small shield measurements were excluded. Both pumped volumes and PAMR were significantly lower with NS use for all data but not for subset data. (All: Volume and PAMR median: no NS: 76.5 mL, 69%, Fitted NS: 32.1 mL, 41% respectively (volume p = 0.002, PAMR p = 0.002); Subset: Volume and PAMR median: no NS: 83.8 mL, 72%; Fitted NS: 35.2 mL, 40% (volume p = 0.111 and PAMR p = 0.045). The difference in PAMR, but not volume, was statistically significant when analysed by linear mixed modelling. A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
CONCLUSIONS


This experimental data suggests that nipple shield use may reduce milk removal. Close clinical monitoring of breastfeeding mothers using nipple shields is warranted.",2020,"A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
",['breastfeeding mothers (infants\u2009<\u20096 months) were recruited'],"['Control Group (CG): no breastfeeding difficulties; Pain Group (PG) used NS', 'Fitted NS']","['milk removal', 'PAMR']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183252', 'cui_str': 'Nipple shield'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]",,0.052731,"A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
","[{'ForeName': 'Viviane Silva', 'Initials': 'VS', 'LastName': 'Coentro', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}, {'ForeName': 'Sharon Lisa', 'Initials': 'SL', 'LastName': 'Perrella', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia. sharon.perrella@uwa.edu.au.'}, {'ForeName': 'Ching Tat', 'Initials': 'CT', 'LastName': 'Lai', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}, {'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Rea', 'Affiliation': 'Mathematics and Statistics, School of Engineering and Information Technology, Murdoch University, 90 South Street, Western Australia, 6150, Murdoch, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, Faculty of Health and Medical Sciences, Population and Global Health, The University of Western Australia, M431, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}, {'ForeName': 'Donna Tracy', 'Initials': 'DT', 'LastName': 'Geddes', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03191-5']
2062,32894075,"Evaluating a frontostriatal working-memory updating-training paradigm in Parkinson's disease: the iPARK trial, a double-blinded randomized controlled trial.","BACKGROUND


Cognitive decline and dementia are common in Parkinson's disease (PD). Cognitive deficits have been linked to the depletion of dopamine in the nigrostriatal pathway, but pharmacological treatments for PD have little evidence of improving or delaying cognitive decline. Therefore, exploring non-pharmacological treatment options is important. There have been some promising results of cognitive training interventions in PD, especially for improvements in working memory and executive functions. Yet, existing studies are often underpowered, lacking appropriate control condition, long term follow-up, a thorough description of the intervention and characteristics of the participants. Working memory updating training has previously shown to increase striatal activation in healthy young and old participants as well as dopaminergic neurotransmission in healthy young participants. In the light of dopamine dysfunction in PD, with negative effects on both motor and cognitive functions it is of interest to study if an impaired striatal system can be responsive to a non-invasive, non-pharmacological intervention.
METHODS AND DESIGN


The iPARK trial is a double-blinded, randomized controlled trial with a parallel-group design that aims to recruit 80 patients with PD (during the period 02/2017-02/2023). Included patients need to have PD, Hoehn and Yahr staging I-III, be between 45 to 75 years of age and not have a diagnosis of dementia. All patients will undergo 30 sessions (6-8 weeks) of web-based cognitive training performed from home. The target intervention is a process-based training program targeting working memory updating. The placebo program is a low dose short-term memory program. A battery of neuropsychological tests and questionnaires will be performed before training, directly after training, and 16 weeks after training.
DISCUSSION


We expect that the iPARK trial will provide novel and clinically useful information on whether updating training is an effective cognitive training paradigm in PD. Further, it will hopefully contribute to a better understanding of cognitive function in PD and provide answers regarding cognitive plasticity as well as determining critical factors for a responsive striatal system.
TRIAL REGISTRATION


Clinicaltrials.gov registry number: NCT03680170 , registry name: ""Cognitive Training in Parkinson's Disease: the iPARK study"", retrospectively registered on the 21st of September 2018. The inclusion of the first participant was the 1st of February 2017.",2020,Working memory updating training has previously shown to increase striatal activation in healthy young and old participants as well as dopaminergic neurotransmission in healthy young participants.,"[""Parkinson's disease (PD"", ""Parkinson's disease"", 'Included patients need to have PD, Hoehn and Yahr staging I-III, be between 45 to 75\u2009years of age and not have a diagnosis of dementia', 'healthy young participants', 'healthy young and old participants', '80 patients with PD (during the period 02/2017-02/2023']","['placebo', 'frontostriatal working-memory updating-training paradigm', 'Working memory updating training', 'Cognitive Training']",['striatal activation'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]",[],80.0,0.126612,Working memory updating training has previously shown to increase striatal activation in healthy young and old participants as well as dopaminergic neurotransmission in healthy young participants.,"[{'ForeName': 'Magdalena Eriksson', 'Initials': 'ME', 'LastName': 'Domellöf', 'Affiliation': 'Department of Psychology, Umeå University, Umeå, Sweden. magdalena.domellof@umu.se.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Walton', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Umeå Center for Functional Brain Imaging (UFBI), Umeå University, Umeå, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bäckström', 'Affiliation': 'Department of Clinical Science, Neuroscience Umeå University, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Josefsson', 'Affiliation': 'Center for Demographic and Aging Research (CEDAR), Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Forsgren', 'Affiliation': 'Department of Clinical Science, Neuroscience Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter Neely', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden. anna.neely@kau.se.'}]",BMC neurology,['10.1186/s12883-020-01893-z']
2063,32894117,Impacts of contracted endodontic cavities compared to traditional endodontic cavities in premolars.,"BACKGROUND


This study aims to compare the percentage of dentin removed, instrumentation efficacy, root canal filling and load at fracture between contracted endodontic cavities, and traditional endodontic cavities on root canal therapy in premolars.
METHODS


Forty extracted intact human first premolars were imaged with micro-CT and randomly assigned to the contracted endodontic cavity (CEC) or traditional endodontic cavity (TEC) groups. CEC was prepared with the aid of a 3D-printed template, canals were prepared with a 0.04 taper M-Two rotary instrument, and cavities were restored with resin. Specimens were loaded to fracture in an Instron Universal Testing Machine after a fatigue phase. The data were analyzed by the independent samples T test and Mann-Whitney U test, appropriate post hoc tests.
RESULTS


In the premolars tested in vitro, the percentage of dentin removed in the premolars with two dental roots in the CEC group (3.85% ± 0.42%) was significantly smaller (P < 0.05) than in the TEC group (4.94% ± 0.5%). The untouched canal wall (UCW) after instrumentation for TECs (16.43% ± 6.56%) was significantly lower (P < .05) than the UCW (24.42% ± 9.19%) for CECs in single-rooted premolars. No significant differences were observed in the increased canal volume and surface areas in premolars between the TEC and CEC groups (P > 0.05). CECs conserved coronal dentin in premolars with two dental roots but no impact on the instrument efficacy. There were no differences between the CEC groups and the TEC groups in the percentage of filling material and voids (P > 0.05). In addition, the mean load at failure of premolars did not significantly differ between the CEC and TEC groups and there was no significant difference in the type of fracture (P > 0.05).
CONCLUSION


The results of this study suggest that CEC could not improve the fracture resistance of the endodontically treated premolars. The instrumentation efficacy and the percentage of filling material did not significantly differ between CECs and TECs in premolars.",2020,The instrumentation efficacy and the percentage of filling material did not significantly differ between CECs and TECs in premolars.,"['premolars', 'Forty extracted intact human first premolars were imaged with']","['micro-CT', 'CEC', 'TEC', 'contracted endodontic cavities', 'contracted endodontic cavity (CEC) or traditional endodontic cavity (TEC']","['percentage of filling material and voids', 'type of fracture', 'fracture resistance', 'instrumentation efficacy and the percentage of filling material', 'percentage of dentin', 'mean load at failure of premolars', 'canal volume and surface areas']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C2350281', 'cui_str': 'MicroCT'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",40.0,0.0319978,The instrumentation efficacy and the percentage of filling material did not significantly differ between CECs and TECs in premolars.,"[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Zhengmao', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Basic Science of Stomatology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Bingpeng', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Orthodontic, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Oral Function and Prosthetic Dentistry, College of Dental Science, Radboud University Nijmegen Medical Centre, Philips van Leydenlaan 25, 6525EX, Nijmegen, The Netherlands.'}, {'ForeName': 'Qianzhou', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Xuechao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China. xcyang@gzhmu.edu.cn.'}]",BMC oral health,['10.1186/s12903-020-01237-w']
2064,32894140,Supplement with whey protein hydrolysate in contrast to carbohydrate supports mitochondrial adaptations in trained runners.,"BACKGROUND


Protein supplementation has been suggested to augment endurance training adaptations by increasing mixed muscle and myofibrillar protein synthesis and lean body mass. However, a potential beneficial effect on mitochondrial adaptations is yet to be clarified. The aim of the present study was to investigate the effect of consuming whey protein hydrolysate before and whey protein hydrolysate plus carbohydrate (PRO-CHO) after each exercise session during a six-week training period compared to similarly timed intake of isocaloric CHO supplements on biomarkers of mitochondrial biogenesis, VO 2max  and performance in trained runners.
METHODS


Twenty-four trained runners (VO 2max  60.7 ± 3.7 ml O 2  kg - 1  min 1 ) completed a six-week block randomized controlled intervention period, consisting of progressive running training. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO 2max , training and performance status. The PRO-CHO group ingested a protein beverage (0.3 g kg - 1 ) before and protein-carbohydrate beverage (0.3 g protein kg - 1  and 1 g carbohydrate kg - 1 ) after each exercise session. The CHO group ingested an energy matched carbohydrate beverage. Resting muscle biopsies obtained pre and post intervention were analyzed for mitochondrial specific enzyme activity and mitochondrial protein content. Subjects completed a 6 K time trial (6 K TT) and a VO 2max  test pre, midway (only 6 K TT) and post intervention.
RESULTS


Following six weeks of endurance training Cytochrome C (Cyt C) protein content was significantly higher in the PRO-CHO group compared to the CHO group (p < 0.05), with several other mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1)) following a similar, but non-significant pattern (p = 0.07-0.14). β-hydroxyacyl-CoA dehydrogenase (HAD) activity was significantly lower after training in the CHO group (p < 0.01), but not in the PRO-CHO group (p = 0.24). VO 2max  and 6 K TT was significantly improved after training with no significant difference between groups.
CONCLUSION


Intake of whey PRO hydrolysate before and whey PRO hydrolysate plus CHO after each exercise session during a six-week endurance training period may augment training effects on specific mitochondrial proteins compared to intake of iso-caloric CHO but does not alter VO 2max  or 6 K TT performance.
TRIAL REGISTRATION


clinicaltrials.gov , NCT03561337 . Registered 6 June 2018 - Retrospectively registered.",2020,"Following six weeks of endurance training Cytochrome C (Cyt C) protein content was significantly higher in the PRO-CHO group compared to the CHO group (p < 0.05), with several other mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1)) following a similar, but non-significant pattern (p = 0.07-0.14).","['Twenty-four trained runners (VO 2max  60.7\u2009±\u20093.7', 'trained runners']","['PRO-CHO or CHO', 'Supplement with whey protein hydrolysate', 'isocaloric CHO supplements', 'consuming whey protein hydrolysate before and whey protein hydrolysate plus carbohydrate (PRO-CHO', 'whey PRO hydrolysate', 'ml O 2  kg -\u20091 \u2009min 1 ) completed a six-week block randomized controlled intervention period, consisting of progressive running training']","['biomarkers of mitochondrial biogenesis, VO 2max  and performance', 'VO 2max  and 6\u2009K TT', 'mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1', 'β-hydroxyacyl-CoA dehydrogenase (HAD) activity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4517696', 'cui_str': '3.7'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494456', 'cui_str': 'Mitochondrial Biogenesis'}, {'cui': 'C0949610', 'cui_str': 'Mitochondrial Protein'}, {'cui': 'C0038615', 'cui_str': 'Succinate dehydrogenase'}, {'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C1506024', 'cui_str': 'Pore Forming Protein VDAC'}, {'cui': 'C0109272', 'cui_str': 'hsp60 Protein'}, {'cui': 'C0084178', 'cui_str': 'prohibitin'}, {'cui': 'C0009226', 'cui_str': 'Coenzyme A'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.038213,"Following six weeks of endurance training Cytochrome C (Cyt C) protein content was significantly higher in the PRO-CHO group compared to the CHO group (p < 0.05), with several other mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1)) following a similar, but non-significant pattern (p = 0.07-0.14).","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark. mhan@ph.au.dk.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Oxfeldt', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Larsen', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Lise S', 'Initials': 'LS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Rokkedal-Lausch', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'De Paoli', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Klavs', 'Initials': 'K', 'LastName': 'Madsen', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00376-3']
2065,32894145,Evaluation of the birth plan implementation: a parallel convergent mixed study.,"BACKGROUND


Pregnancy, birth, and motherhood are among the most important events of every woman's life. Training and participation of mothers in the decision-making process of delivery play an essential role in physical as well as psychosocial preparation of the mother. The healthcare system can improve and enhance the level of care by involving the patient in their self-care process. The aim of the present study is to assess the implementation of the birth plan for the first time in Iran in Tabriz city.
METHODS/DESIGN


The present study uses a mixed-method with a parallel convergence approach, including both quantitative and qualitative phases. The quantitative phase is a randomized controlled clinical trial performed on 106 pregnant women, 32-36 weeks of pregnancy, referring to Taleghani educational hospital in Tabriz city. The participants will be assigned into intervention and control groups using a randomized block method. A training session will be held about the items of the birth plan checklist at weeks 32-36 of gestation for the participants in the intervention group, whereby a mother-requested birth plan will be developed. It will then be implemented by the researcher after admitting them to the delivery ward. Also, those in the control group will receive routine care. During and after the delivery, the questionnaire of delivery information, neonatal information, and Delivery Fear Scale (DFS) will be completed. Also, a partogram will be completed for all participants by the researcher. The participants in both groups will be followed up until six weeks post-delivery, whereby the instruments of Childbirth Experience Questionnaire (CEQ2.0), Edinburgh's Postpartum Depression Scale and PTSD Symptom Scale 1 (PSS-I) will be completed six weeks 4-6 weeks postpartum by the researcher through an interview with participants in Taleghani educational hospital. The general linear model and multivariate logistic regression model will be used while controlling the possible confounding variables. The qualitative phase will be performed to explore the women's perception of the effect of the birth plan on childbirth experience within 4-6 weeks postpartum. The sampling will be of a purposeful type on the women who would receive the birth plan and will continue until data saturation. In-depth, semi-structured individual interviews would be used for data collection. The data analysis will be done through content analysis with a conventional approach. The results of the quantitative and qualitative phases will be analyzed separately, and then combined in the interpretation stage.
DISCUSSION


By investigating the effect of implementing the birth plan on the childbirth experience of women as well as other maternal and neonatal outcomes, an evidence-based insight can be offered using a culturally sensitive approach. The presentation of the results obtained from this study using the mixed method may be effective in improving the quality of care provided for women during labor.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N58. Date of registration: July 7, 2020. URL: https://en.irct.ir/user/trial/47007/view.",2020,The qualitative phase will be performed to explore the women's perception of the effect of the birth plan on childbirth experience within 4-6 weeks postpartum.,"['106 pregnant women, 32-36\u2009weeks of pregnancy, referring to Taleghani educational hospital in Tabriz city', 'Iran in Tabriz city']",[],"[""Childbirth Experience Questionnaire (CEQ2.0), Edinburgh's Postpartum Depression Scale and PTSD Symptom Scale"", 'questionnaire of delivery information, neonatal information, and Delivery Fear Scale (DFS']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia'}]",106.0,0.0467964,The qualitative phase will be performed to explore the women's perception of the effect of the birth plan on childbirth experience within 4-6 weeks postpartum.,"[{'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Ahmadpour', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mosavi', 'Affiliation': 'Women Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Jahanfar', 'Affiliation': 'Public Health Department, Central Michigan University, Mount Pleasant, MI, USA.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvand@gmail.com.'}]",Reproductive health,['10.1186/s12978-020-00989-6']
2066,32894159,"Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial.","BACKGROUND


The Getting it Right: Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. This article describes the statistical analysis plan for the GRASP randomised controlled trial.
METHODS/DESIGN


GRASP is a multicentre randomised controlled trial using a 2 × 2 factorial design. Adults aged ≥ 18 years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery, are randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection then best practice advice. The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score over 12 months. Secondary outcomes are as follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability. Here, we describe in detail the following: sample size calculation, descriptive statistics of the primary and secondary outcomes, statistical models used for the analysis of the main outcomes, handling of missing data, planned sensitivity and subgroup analyses. This pre-specified statistical analysis plan was written and submitted without prior knowledge of the trial results.
DISCUSSION


Publication of the statistical analysis plan for the GRASP trial aims to reduce the risk of outcome reporting bias and increase transparency of the data analysis. Any deviations or changes to the current SAP will be described and justified in the final study report and any results publications.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number ISRCTN16539266 . Registered on 14 June 2016. EudraCT number 2016-002991-28. Registered on 12 June 2016.",2020,"Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.","['Adults aged ≥\u200918\u2009years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery', 'Right', 'adults with a rotator cuff disorder']","['GRASP', 'Progressive exercise compared with best practice advice, with or without corticosteroid injection', 'progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection', 'progressive exercise compared with best practice advice, with or without corticosteroid injection']","['Addressing Shoulder Pain', 'mean difference in Shoulder Pain and Disability Index (SPADI) total score', 'follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3815933', 'cui_str': 'Uninsured medical expenses'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",,0.256568,"Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.","[{'ForeName': 'Ioana R', 'Initials': 'IR', 'LastName': 'Marian', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK. ioana.marian@csm.ox.ac.uk.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and Oxford NIHR Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Cureton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Centre for Rehabilitation Research, Nuffield Department of Rheumatology, Orthopaedics and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK.'}]",Trials,['10.1186/s13063-020-04704-5']
2067,32894190,"Acupuncture treatment for carotid atherosclerotic plaques: study protocol for a pilot randomized, single blinded, controlled clinical trial.","BACKGROUND


Carotid atherosclerosis disease (CAD) is generally associated with the occurrence of cardiovascular and cerebrovascular accidents. However, CAD has not been taken seriously enough in the clinic, which, coupled with the single treatment and prevention of CAD, has led to a generally low level of patient compliance. Therefore, acupuncture is expected to be a safe and effective therapy that can be maintained in the long term for patients with CAD. The study objective is to evaluate the efficiency and reliability of acupuncture to relieve CAD and provide a new therapeutic idea for the clinical treatment of CAD.
METHODS


This is a three-arm randomized clinical trial in China. Three groups (TA, SA, and MC) will be randomly allocated at a 1:1:1 ratio. The study will enrol 105 cervical atherosclerosis plaque patients in total on a voluntary basis, with 35 patients in each group. The treatment will last for 12 weeks, with two treatments per week for twenty-four treatments in total.
RESULTS


Two 3D ultrasound indicators will be measured as the primary outcomes: the total plaque volume (PV) of the carotid artery on each side and the grey-scale median (GSM). The secondary outcomes will include intima-media thickness (IMT), lipid levels, apolipoprotein A-IV level, platelet count (PLT), fibrinogen (FIB), and platelet aggregation rate (PAR). All the outcomes will be assessed before treatment, after treatment, and after a 12-week follow-up period. This study will utilize per-protocol (PP) and intention-to-treat (ITT) analysis principles.
CONCLUSIONS


This trial is to evaluate the efficacy and reliability of acupuncture in relieving carotid atherosclerotic plaques by establishing acupuncture (TA), sham acupuncture (SA), and medication (MC) groups.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine (no. YF2018-107-01). All data and findings will be provided by the principal investigator via email.
TRIAL REGISTRATION


ChiCTR, ChiCTR1800019259 . Registered on 1 November 2018-retrospectively registered, http://www.chictr.org.cn/index.aspx.",2020,"This trial is to evaluate the efficacy and reliability of acupuncture in relieving carotid atherosclerotic plaques by establishing acupuncture (TA), sham acupuncture (SA), and medication (MC) groups.
","['patients with CAD', '105 cervical atherosclerosis plaque patients in total on a voluntary basis, with 35 patients in each group', 'carotid atherosclerotic plaques']","['acupuncture (TA), sham acupuncture (SA), and medication (MC', 'Acupuncture treatment', 'acupuncture']","['intima-media thickness (IMT), lipid levels, apolipoprotein A-IV level, platelet count (PLT), fibrinogen (FIB), and platelet aggregation rate (PAR', 'total plaque volume (PV) of the carotid artery on each side and the grey-scale median (GSM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0052181', 'cui_str': 'Apolipoprotein A-IV'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C1269776', 'cui_str': 'Gray color'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",105.0,0.133557,"This trial is to evaluate the efficacy and reliability of acupuncture in relieving carotid atherosclerotic plaques by establishing acupuncture (TA), sham acupuncture (SA), and medication (MC) groups.
","[{'ForeName': 'Junhe', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Lingcui', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Ultrasonography Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Huitao', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Ultrasonography Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Siting', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Ultrasonography Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Zhiqi', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Acupuncture Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Xichang', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Acupuncture Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Shenzhen Bao'an Research Centre for Acupuncture and Moxibustion, Shenzhen, China. zpszba@163.com.""}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China. fuwenbin@139.com.'}]",Trials,['10.1186/s13063-020-04709-0']
2068,32891709,Influence of n-acetylcysteine maintenance on the pharmacodynamic effects of oral ethanol.,"RATIONALE


Glutamate systems play an important role in the abuse related effects of alcohol. n-Acetylcysteine, a drug that promotes glutamate homeostasis, attenuates a range of alcohol effects in preclinical models.
OBJECTIVES


This human laboratory study determined the influence of n-acetylcysteine maintenance on alcohol self-administration using a model predictive of treatment effectiveness, along with the subjective, performance and physiological effects of alcohol. We hypothesized that n-acetylcysteine would attenuate alcohol self-administration, as well as positive subjective effects of alcohol.
METHODS


Nine subjects with alcohol use disorder completed this within-subjects study. Subjects were maintained on placebo, 1.2 and 2.4 g n-acetylcysteine in random order on an outpatient basis. After five days of maintenance on the target dose, subjects completed overnight inpatient experimental sessions in which the pharmacodynamic effects of alcohol were determined.
RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink). n-Acetylcysteine did not alter the effects of alcohol.
CONCLUSIONS


These results indicate that although n-acetylcysteine can safely be combined with alcohol, it does not attenuate the abuse related effects of alcohol and is unlikely to be an effective standalone alcohol use disorder treatment. However, considering study limitations, future work is needed to further understand whether and how n-acetylcysteine might be used as a treatment for alcohol use disorder (e.g., in combination with a behavioral treatment or another pharmacological agent).",2020,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).",['Nine subjects with alcohol use disorder completed this within-subjects study'],"['placebo', 'oral ethanol']","['breath alcohol concentration, increased ratings of Feel Drink']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",9.0,0.012153,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA. Electronic address: william.stoops@uky.edu.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Lon R', 'Initials': 'LR', 'LastName': 'Hays', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Abner O', 'Initials': 'AO', 'LastName': 'Rayapati', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173037']
2069,32891871,No tDCS augmented working memory training benefit in undergraduates rewarded with course credit.,"BACKGROUND


The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE


To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS


80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS


No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS


This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA; University of California, Davis, Program in Neuroscience, Davis, CA, 95616, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
2070,32891892,A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction.,"INTRODUCTION


Quantitative Electroencephalogram-(QEEG-)informed neurofeedback is a method in which standard neurofeedback protocols are assigned, based on individual EEG characteristics in order to enhance effectiveness. Thus far clinical effectiveness data have only been published in a small sample of 21 ADHD patients. Therefore, this manuscript aims to replicate this effectiveness in a new sample of 114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset and to investigate potential predictors of neurofeedback response.
METHODS


A sample of 114 patients were included as a replication sample. Patients were treated with standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice. The ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, every 10th session, and at outtake. Holland Sleep Disorder Questionnaire (HSDQ) was assessed at baseline and outtake. Response was defined as ≥25% reduction (R25), ≥50% reduction (R50), and remission. Predictive analyses were focused on predicting remission status.
RESULTS


In the current sample, response rates were 85% (R25), 70% (R50), and remission was 55% and clinical effectiveness was not significantly different from the original 2012 sample. Non-remitters exhibited significantly higher baseline hyperactivity ratings. Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
DISCUSSION


In the current sample, clinical effectiveness was replicated, suggesting it is possible to assign patients to a protocol based on their individual baseline QEEG to enhance signal-to-noise ratio. Furthermore, remitters had lower baseline hyperactivity scores. Likewise, female remitters had shorter P300 latencies, whereas boys who remitted have a lower iAPF. Our data suggests initial specificity in treatment allocation, yet further studies are needed to replicate the predictors of neurofeedback remission.",2020,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","['21 ADHD patients', 'A sample of 114 patients were included as a replication sample', '114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset']","['standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice', 'QEEG']","['Holland Sleep Disorder Questionnaire (HSDQ', 'response rates', 'ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI', 'baseline hyperactivity scores', 'shorter P300 latencies', 'clinical effectiveness', 'baseline hyperactivity ratings']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",114.0,0.0593453,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","[{'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Egtberts', 'Affiliation': 'neuroCare Group Netherlands, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Sack', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; neuroCare Group, Munich, Germany; kbo-Heckscher-Klinikum, Munich, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'neuroCare Group, Sydney, Australia.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; Dept. of Experimental Psychology, Utrecht University, Utrecht, The Netherlands. Electronic address: martijn@brainclinics.com.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102399']
2071,32891918,Working memory moderates the relation between the brain-derived neurotropic factor (BDNF) and psychotherapy outcome for depression.,"BACKGROUND


Insight into patient characteristics that predict response to treatment for major depressive disorder (MDD) may help to personalize treatment and improve outcomes. One mechanism that has been linked to the success of treatment for MDD is brain-derived neurotropic factor (BDNF). BDNF is implicated in learning and memory and may play a role in the effects of psychotherapy that involves changing cognitions and behaviors. In addition, only in individuals with low BDNF, low working memory capacity has been associated with increased symptoms of depression. However, the role of BDNF and working memory capacity in psychotherapy outcome is unclear. The aim of this study was to investigate the role of BDNF and its interaction with working memory capacity in psychotherapy outcomes for MDD.
METHOD


Adult patients with MDD were randomized to weekly or twice weekly sessions of cognitive behavioral therapy or interpersonal psychotherapy. BDNF Val66Met polymorphism (rs6265) (n = 138) was defined and serum BDNF was quantified before (n = 138) and after psychotherapy (n = 82).
RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions. Working memory capacity significantly moderated the relation between baseline serum BDNF and outcome: high serum BDNF at baseline was related to less depressive symptoms following psychotherapy in the presence of high working memory capacity, but not low working memory capacity.
DISCUSSION


These findings, if replicated, might indicate that while BDNF may not be related to psychotherapy outcomes in general, they may play a role in the presence of specific learning processes such as working memory capacity.",2020,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","['Adult patients with MDD', 'major depressive disorder (MDD']","['cognitive behavioral therapy or interpersonal psychotherapy', 'BDNF', 'brain-derived neurotropic factor (BDNF) and psychotherapy']","['serum BDNF', 'depressive symptoms', 'Baseline serum BDNF and the Val66Met polymorphism']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]",138.0,0.0539135,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","[{'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany. Electronic address: sanne.bruijniks@psychologie.uni-freiburg.de.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'de Kluiver', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Christiaan H', 'Initials': 'CH', 'LastName': 'Vinkers', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; Department of Anatomy and Neurosciences, Amsterdam University Medical Center, Amsterdam Neuroscience, Amsterdam, the Netherlands.'}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Neurochemistry Lab, Department of Clinical Chemistry, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam Neuroscience, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, Philadelphia, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.045']
2072,32891977,Social network heavy drinking moderates the effects of a brief motivational intervention for alcohol use among injured patients.,"BACKGROUND


Limited research has focused on identifying the extent to which social networks impact the effectiveness of brief alcohol interventions delivered in trauma care settings.
OBJECTIVES


The research presented here examines the extent to which the percent of heavy drinkers and percent of abstainers in one's social network moderates the effectiveness of a brief motivational intervention with and without a telephone booster on alcohol use among trauma patients.
METHOD


Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers. Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193). For the purpose of the present study, measures of alcohol-specific social network characteristics at baseline and alcohol use at 3- and 6-month follow-up were used.
RESULTS


At low percentages (0% to ~7%) of people in one's social network who are heavy drinkers, there was a negative, statistically significant effect of the BMI conditions versus the BA condition on alcohol use. However, percent of abstainers did not moderate the effects of the BMI conditions.
CONCLUSION


The results suggest that the BMI and BMI + B conditions may be most effective among patients with no heavy drinkers in their social networks. BMIs may benefit from including a component that addresses having one or more heavy drinkers in one's social network.",2020,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","['injured patients', 'trauma patients', 'Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers', 'patients with no heavy drinkers in their social networks']","['motivational intervention', 'motivational intervention with and without a telephone booster', 'brief advice (BA; n\xa0=\xa0200), brief motivational intervention (BMI; n\xa0=\xa0203), and BMI with a telephone booster (BMI\xa0+\xa0B; n\xa0=\xa0193']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],596.0,0.015999,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA. Electronic address: mjalvarez2@miners.utep.edu.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oviedo Ramirez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106594']
2073,32892129,Efficacy of Automatic Retention Pressure of a Double-Lumen Tube Cuff: An Artificial Intubation Model.,"BACKGROUND


The movement of a double-lumen endotracheal tube (DLT) out of its appropriate position during thoracic surgery can result in the loss of one-lung ventilation (OLV), especially during pulmonary resection and node dissection. Our study aimed to validate the efficacy of automatic retention pressure control of the DLT bronchial cuff in maintaining OLV in an artificial intubation model.
MATERIALS AND METHODS


A 35-Fr left-sided DLT was intubated to the left main bronchus in an intubation simulator and connected to an anesthesia machine. The inspiratory volume, respiratory rate, and inspiratory-expiratory ratio were set at 500 mL, 12 times/min, and 1:2, respectively. A 1-kg right main bronchial traction in the lateral right was provided after OLV was established. SmartCuff (Smiths Medical, Minneapolis, Minnesota, USA) was used to maintain cuff pressure. The efficacy of retention pressure with SmartCuff (Group S) and without SmartCuff (Group WS) was compared. The primary outcome was the rate of tidal volume (TV) reduction following bronchial traction in the two groups.
RESULTS


The TVs were 289.8 ± 28.9 mL and 242.8 ± 31.9 mL in Group S and Group WS, respectively (P = 0.003). The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
CONCLUSIONS


Automatic retention pressure control of the DLT bronchial cuff improves the rate of TV reduction during right main bronchial traction in an artificial intubation model. Continuous retention cuff pressure may be useful in maintaining OLV during thoracic surgery.",2020,"The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
",[],"['SmartCuff (Group S) and without SmartCuff (Group WS', 'Automatic Retention Pressure of a Double-Lumen Tube Cuff', 'automatic retention pressure control of the DLT bronchial cuff', 'SmartCuff ']","['rate of TV reduction', 'rate of TV reduction after bronchial traction', 'inspiratory volume, respiratory rate, and inspiratory-expiratory ratio', 'rate of tidal volume (TV) reduction following bronchial traction']",[],"[{'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441110', 'cui_str': 'Tube cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",,0.0364977,"The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan. Electronic address: y_takahashi@sapmed.ac.jp.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tada', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Maki', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}]",The Journal of surgical research,['10.1016/j.jss.2020.08.017']
2074,32892297,Influence of Male Partners on HIV Disclosure Among South African Women in a Cluster Randomized PMTCT Intervention.,"Disclosure of HIV serostatus is beneficial for women, their partners, and their infants as it enables women to actively participate in preventative care (Hodgson et al. in PLoS ONE 9(11):e111421, 2014; Odiachi et al. in Reprod Health 15(1):36, 2018). Therefore, it is important that interventions addressing HIV prevention include elements that foster disclosure of HIV to partners. This study conducted in South Africa utilizes the ""Protect Your Family"" (PYF) behavioral intervention and compares Prevention of Mother to Child Transmission (PMTCT) among women participating in the program versus those in a control program. Within both groups, male partners were either present or not present for the intervention. The purpose of this study was to examine differential disclosure over time for individuals in the different conditions and partner involvement. A firth logistic regression revealed an interaction in the experimental condition with male partners participating (b = - 2.84, SE = 1.56, p = .012), in which female participants were less likely to disclose their HIV status over time. Findings from this study illustrate that additional efforts are needed to empower women to disclose their HIV status.",2020,"A firth logistic regression revealed an interaction in the experimental condition with male partners participating (b = - 2.84, SE = 1.56, p = .012), in which female participants were less likely to disclose their HIV status over time.","['women participating in the program versus those in a control program', 'Male Partners on HIV Disclosure Among South African Women', 'individuals in the different conditions and partner involvement']","['Protect Your Family"" (PYF) behavioral intervention and compares Prevention of Mother to Child Transmission (PMTCT']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],,0.0189652,"A firth logistic regression revealed an interaction in the experimental condition with male partners participating (b = - 2.84, SE = 1.56, p = .012), in which female participants were less likely to disclose their HIV status over time.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Dominion Towers Suite 404, 1400 NW 10th Avenue, Miami, FL, 33136, USA.'}, {'ForeName': 'Manasi S', 'Initials': 'MS', 'LastName': 'Parrish', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, USA.'}, {'ForeName': 'Tae K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, USA.'}, {'ForeName': 'Shandir', 'Initials': 'S', 'LastName': 'Ramlagan', 'Affiliation': 'HIV/AIDS/STIs and TB Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'Sibusiso', 'Initials': 'S', 'LastName': 'Sifunda', 'Affiliation': 'HIV/AIDS/STIs and TB Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Dominion Towers Suite 404, 1400 NW 10th Avenue, Miami, FL, 33136, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Dominion Towers Suite 404, 1400 NW 10th Avenue, Miami, FL, 33136, USA. djones@med.miami.edu.'}]",AIDS and behavior,['10.1007/s10461-020-03021-x']
2075,32525975,Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemophilia.,"OBJECTIVE


Strength training is recommended for people with hemophilia; however, published data are anecdotal and have methodological limitations. The purpose of this study was to evaluate the safety and effectiveness of progressive moderate-to-vigorous intensity elastic resistance training on physical function and pain in this patient population.
METHODS


A randomized controlled trial was conducted in a university laboratory setting where 20 patients (17 with severe, 1 with moderate, and 2 with mild hemophilia) aged 21 to 53 years received evaluations at baseline and 8-week follow-up. Participants were allocated to intervention (progressive strength training) or control (usual daily activities) groups. The intervention group trained 2 days per week during 8 weeks with elastic resistance. Intensity during the first 2 weeks was a 20-repetition maximum and increased progressively toward 15, 12, and finally 10 repetition maximum. The primary outcome was muscle strength. Secondary outcomes were the Timed ""Up and Go"" Test score, sit-to-stand, range of motion, Haemophilia Joint Health Score, kinesiophobia score, global impression of pain change, general self-rated health status, and desire to exercise.
RESULTS


The intervention group showed greater strength improvements than the control group in almost all of the joints, with moderate to high effect sizes. The intervention group also showed better Timed ""Up and Go"" and sit-to-stand scores than the control group (moderate effect size), greater range of motion at the knee flexion with the right leg (trivial effect size), and better Haemophilia Joint Health Score at the left knee (small effect size). The intervention group showed greater overall pain reduction, self-rated overall status, and desire to exercise than the control group.
CONCLUSIONS


Progressive strength training with elastic resistance performed twice a week during 8 weeks is safe and effective in people with hemophilia to improve muscle strength and functional capacity, reduce general pain, and improve self-rated health status and desire to exercise.
IMPACT


This study provides evidence for the use of a specific strength training regimen for people with hemophilia.
LAY SUMMARY


People with hemophilia of differing levels of severity, with adequate coverage with clotting factor, can safely engage in progressive strength training and can improve their functioning.",2020,"The intervention group also showed better Timed ""Up and Go"" and sit-to-stand scores than the control group (moderate effect size), greater range of motion at the knee flexion with the right leg (trivial effect size), and better Haemophilia Joint Health Score at the left knee (small effect size).","['People With Hemophilia', '20 patients (17 with severe, 1 with moderate, and 2 with mild hemophilia) aged 21 to 53\xa0years received evaluations at baseline and 8-week follow-up', 'people with hemophilia']","['specific strength training regimen', 'Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training', 'intervention (progressive strength training) or control (usual daily activities', 'progressive moderate-to-vigorous intensity elastic resistance training']","['muscle strength', 'overall pain reduction, self-rated overall status, and desire to exercise', 'Timed ""Up and Go"" Test score, sit-to-stand, range of motion, Haemophilia Joint Health Score, kinesiophobia score, global impression of pain change, general self-rated health status, and desire to exercise', 'Physical Function and Pain', 'Haemophilia Joint Health Score', 'physical function and pain', 'strength improvements', 'Timed ""Up and Go"" and sit-to-stand scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.076451,"The intervention group also showed better Timed ""Up and Go"" and sit-to-stand scores than the control group (moderate effect size), greater range of motion at the knee flexion with the right leg (trivial effect size), and better Haemophilia Joint Health Score at the left knee (small effect size).","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Department of Physiotherapy, Exercise Intervention for Health Research Group, University of Valencia, Valencia, Spain; and National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Pérez-Alenda', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion, University of Valencia, Gascó Oliag 5, Valencia CP 46100 Spain; and Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Carrasco', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion and Intelligent Data Analysis Laboratory, University of Valencia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cruz-Montecinos', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion, University of Valencia and Department of Physical Therapy, Faculty of Medicine, Laboratory of Clinical Biomechanics, University of Chile, Santiago, Chile.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment and Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bonanad', 'Affiliation': 'Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Querol', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion, University of Valencia and Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Megías-Vericat', 'Affiliation': 'Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe and Pharmacy Department, Drug Clinical Area, University and Polytechnic Hospital La Fe.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Department of Physiotherapy, Exercise Intervention for Health Research Group, University of Valencia.'}]",Physical therapy,['10.1093/ptj/pzaa106']
2076,32868247,"Focused, low tube potential, coronary calcium assessment prior to coronary CT angiography: A prospective, randomized clinical trial.","BACKGROUND


Coronary artery calcium (CAC) scanning is commonly performed before coronary CT angiography (CTA) based partly on its potential to influence CTA scan parameters. Encompassing the whole heart and performed at high tube potential (120 kVp), standard (Agatston) CAC scanning adds to patient radiation exposure. Most CAC exists in the proximal and mid coronary segments and is easily visualized at low kVp.
METHODS


We tested the impact of a modified calcium scan on coronary CTA acquisition decision-making and image quality in a randomized clinical trial. Providers documented planned CTA acquisition parameters prior to CAC scanning in a blinded manner. Standard Agatston CAC scans proceeded in typical fashion whereas modified scans utilized 80 kVp and reduced z-axis length focused on the proximal-to-mid coronary arteries. CTA providers reviewed the CAC burden then documented final acquisition parameters.
RESULTS


The study included 172 patients (48% female; mean age 59 ± 6.7). As planned, the calcium scan effective dose was significantly lower in the modified CAC scan group (0.14 vs. 0.74 mSv using a 0.014 k-factor or 0.26 vs. 1.38 mSv using a 0.026 k-factor; both p < 0.001). Initially selected CTA parameters were changed at an identical rate following visual CAC assessment (59%). There was no significant difference in coronary CTA image quality (median quality score = 4 in both groups, p = 0.26), noise (31.0 vs 31.4 HU; p = 0.81), or signal/noise ratio (17.9 vs 16.8; p = 0.26).
CONCLUSIONS


A low-kVp scan with focused field-of-view provides actionable information regarding the presence and severity of CAC prior to coronary CTA. Coronary CTA parameters based on patient variables are frequently modified after assessing CAC burden in the CTA suite. CLINICALTRIALS.
GOV REGISTRATION NUMBER


NCT02972242.",2020,"There was no significant difference in coronary CTA image quality (median quality score = 4 in both groups, p = 0.26), noise (31.0 vs 31.4 HU; p = 0.81), or signal/noise ratio (17.9 vs 16.8; p = 0.26).
",['172 patients (48% female; mean age 59\xa0±\xa06.7'],"['standard (Agatston) CAC scanning', 'coronary CT angiography (CTA', 'modified CAC scan', 'Coronary artery calcium (CAC) scanning', 'modified calcium scan', 'low tube potential, coronary calcium assessment prior to coronary CT angiography']","['z-axis length', 'coronary CTA image quality', 'calcium scan effective dose']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",172.0,0.051731,"There was no significant difference in coronary CTA image quality (median quality score = 4 in both groups, p = 0.26), noise (31.0 vs 31.4 HU; p = 0.81), or signal/noise ratio (17.9 vs 16.8; p = 0.26).
","[{'ForeName': 'Hampton A', 'Initials': 'HA', 'LastName': 'Crimm', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA. Electronic address: hampton.a.crimm.mil@mail.mil.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Fergestrom', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Cicely', 'Initials': 'C', 'LastName': 'Dye', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Philip', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Binh T', 'Initials': 'BT', 'LastName': 'Nguyen', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'University of Virginia Health System, Charlottesville, VA, USA.'}]",Journal of cardiovascular computed tomography,['10.1016/j.jcct.2020.08.011']
2077,32868370,'Immunity Passports' for SARS-CoV-2: an online experimental study of the impact of antibody test terminology on perceived risk and behaviour.,"OBJECTIVE


To assess the impact of describing an antibody-positive test result using the terms Immunity and Passport or Certificate, alone or in combination, on perceived risk of becoming infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and protective behaviours.
DESIGN


2×3 experimental design.
SETTING


Online.
PARTICIPANTS


1204 adults from a UK research panel.
INTERVENTION


Participants were randomised to receive one of six descriptions of an antibody test and results showing SARS-CoV-2 antibodies, differing in the terms describing the type of test (Immunity vs Antibody) and the test result (Passport vs Certificate vs Test).
MAIN OUTCOME MEASURES


Primary outcome: proportion of participants perceiving no risk of infection with SARS-CoV-2 given an antibody-positive test result. Other outcomes include: intended changes to frequency of hand washing and physical distancing.
RESULTS


When using the term Immunity (vs Antibody), 19.1% of participants (95% CI 16.1% to 22.5%) (vs 9.8% (95% CI 7.5% to 12.4%)) perceived no risk of catching coronavirus given an antibody-positive test result (adjusted OR (AOR): 2.91 (95% CI 1.52 to 5.55)). Using the terms Passport or Certificate-as opposed to Test-had no significant effect (AOR: 1.24 (95% CI 0.62 to 2.48) and AOR: 0.96 (95% CI 0.47 to 1.99) respectively). There was no significant interaction between the effects of the test and result terminology. Across groups, perceiving no risk of infection was associated with an intention to wash hands less frequently (AOR: 2.32 (95% CI 1.25 to 4.28)); there was no significant association with intended avoidance of physical contact (AOR: 1.37 (95% CI 0.93 to 2.03)).
CONCLUSIONS


Using the term Immunity (vs Antibody) to describe antibody tests for SARS-CoV-2 increases the proportion of people believing that an antibody-positive result means they have no risk of catching coronavirus in the future, a perception that may be associated with less frequent hand washing.
TRIAL REGISTRATION NUMBER


Open Science Framework: https://osf.io/tjwz8/files/.",2020,"Using the term Immunity (vs Antibody) to describe antibody tests for SARS-CoV-2 increases the proportion of people believing that an antibody-positive result means they have no risk of catching coronavirus in the future, a perception that may be associated with less frequent hand washing.
",['1204 adults from a UK research panel'],[],"['proportion of participants perceiving no risk of infection with SARS-CoV-2 given an antibody-positive test result', 'frequency of hand washing and physical distancing', 'intended avoidance of physical contact', 'perceiving no risk of infection', 'no risk of catching coronavirus given an antibody-positive test result (adjusted OR (AOR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0221190', 'cui_str': 'Physical contact'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",1204.0,0.116759,"Using the term Immunity (vs Antibody) to describe antibody tests for SARS-CoV-2 increases the proportion of people believing that an antibody-positive result means they have no risk of catching coronavirus in the future, a perception that may be associated with less frequent hand washing.
","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'G James', 'Initials': 'GJ', 'LastName': 'Rubin', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Henry W W', 'Initials': 'HWW', 'LastName': 'Potts', 'Affiliation': 'Centre for Health Informatics and Multiprofessional Education, UCL, London, UK.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Mottershaw', 'Affiliation': 'Behavioural Insights Team, London, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, UK tm388@cam.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-040448']
2078,32868483,Analgesic efficacy of adding the IPACK block to a multimodal analgesia protocol for primary total knee arthroplasty.,"BACKGROUND AND OBJECTIVES


Peripheral nerve blocks have been integrated into most multimodal analgesia protocols for total knee arthroplasty (TKA). The adductor canal block (ACB) has gained popularity because of its quadriceps muscle sparing. Similarly, local anesthetic injection between the popliteal artery and the posterior capsule of the knee, IPACK block, has been described to provide analgesia to the posterior capsule of the knee with motor-sparing qualities. This prospective randomized controlled trial aimed to assess the analgesic efficacy of adding the IPACK block to our current multimodal analgesic regimen, including the ACB, in patients undergoing primary TKA.
METHODS


119 patients were randomized to receive either an IPACK or a sham block in addition to multimodal analgesia and an ACB. We were set to assess pain in the back of the knee 6 hours after surgery. Other end points included quality of recovery after surgery, pain scores, opioid requirements, and functional measures.
RESULTS


Patients who received the IPACK block had less pain in the back of the knee 6 hours after surgery when compared with the sham block: 21.7% vs 45.8%, p<0.01. There was marginal improvement in other pain measures in the first 24 hours after surgery. However, opioid requirements, quality of recovery and functional measures were similar between the two groups.
CONCLUSION


The IPACK block reduced the incidence of posterior knee pain 6 hours postoperatively.",2020,"However, opioid requirements, quality of recovery and functional measures were similar between the two groups.
","['total knee arthroplasty (TKA', '119 patients', 'patients undergoing primary TKA', 'primary total knee arthroplasty']","['IPACK or a sham block in addition to multimodal analgesia and an ACB', 'IPACK block', 'adductor canal block (ACB']","['posterior knee pain', 'quality of recovery after surgery, pain scores, opioid requirements, and functional measures', 'pain measures', 'Analgesic efficacy', 'analgesic efficacy', 'quality of recovery and functional measures', 'pain']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",119.0,0.178948,"However, opioid requirements, quality of recovery and functional measures were similar between the two groups.
","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Ochroch', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Badiola', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Grosh', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Graff', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': 'Department of Orthopedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Israelite', 'Affiliation': 'Department of Orthopedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nabil M', 'Initials': 'NM', 'LastName': 'Elkassabany', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA nabil.elkassabany@uphs.upenn.edu.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101558']
2079,32868991,Guided Internet-delivered cognitive behaviour therapy for perfectionism in a non-clinical sample of adolescents: A study protocol for a randomised controlled trial.,"Background


Perfectionism is elevated across a range of psychopathologies and has been shown to impede treatment outcomes. There is also evidence suggesting elevated perfectionism may contribute to the onset and maintenance of non-suicidal self-injury. There is a growing body of evidence suggesting that Internet-delivered cognitive-behavioural therapy for perfectionism reduces perfectionism and symptoms of psychological disorders and that reductions are maintained at 3-month and 6-month follow-up. There may also be reductions in non-suicidal self-injury, although no study has investigated this potential benefit. Given that associations between perfectionism and psychopathology are observed across both adults and adolescents, the need for the development of interventions targeting adolescents is essential for early intervention and prevention.
Methods


The present study will employ a randomised controlled trial to examine the efficacy of 8-week guided Internet-delivered cognitive-behavioural therapy for perfectionism in adolescents compared to a waitlist control group. The primary outcome is perfectionism, and secondary outcomes include symptoms of psychological disorders, well-being, and non-suicidal self-injury. Outcomes will be assessed at pre-intervention, post-intervention, 1-month follow-up, 3-month follow-up, and 6-month follow-up. A minimum of 240 participants will be recruited online through social media, Australian universities, and schools across Australia. Generalised linear mixed models will be used to test for changes in outcomes between the intervention group and the waitlist control.
Discussion


The outcomes of this trial will contribute to the literature on perfectionism and psychopathology in adolescents, as well as the efficacy of guided Internet-delivered interventions for adolescents.
Trial registration


The trial was registered on the 20th of June 2019 at the Australia New Zealand Clinical Trials Registry (ACTRN12619000881134).
Trial status


This is protocol version 1.0. Participant recruitment began on 31 July 2019 and is still actively running with an anticipated completion date in the fourth quarter of 2020.",2020,There is a growing body of evidence suggesting that Internet-delivered cognitive-behavioural therapy for perfectionism reduces perfectionism and symptoms of psychological disorders and that reductions are maintained at 3-month and 6-month follow-up.,"['20 th  of June 2019 at the Australia New Zealand Clinical Trials Registry (ACTRN12619000881134).Trial StatusThis is protocol version 1.0', 'Adolescents', 'adolescents', '240 participants will be recruited online through social media, Australian universities, and schools across Australia']","['guided Internet-delivered cognitive-behavioural therapy', 'Guided Internet-Delivered Cognitive Behaviour Therapy']","['perfectionism, and secondary outcomes include symptoms of psychological disorders, well-being, and non-suicidal self-injury']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",,0.13653,There is a growing body of evidence suggesting that Internet-delivered cognitive-behavioural therapy for perfectionism reduces perfectionism and symptoms of psychological disorders and that reductions are maintained at 3-month and 6-month follow-up.,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Howell', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Tonta', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Egan', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Hasking', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Boyes', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'McEvoy', 'Affiliation': 'Centre for Clinical Interventions, Western Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Mazzucchelli', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}]",Internet interventions,['10.1016/j.invent.2020.100342']
2080,32869065,Erratum for Iannotti L et al. Eggs early in complementary feeding increased choline pathway biomarkers and DHA: a randomized controlled trial in Ecuador. Am J Clin Nutr 2017;106(6):1482-89. doi: 10.3945/ajcn.117.160515.,,2020,,['doi'],[],[],[],[],[],,0.063532,,[],The American journal of clinical nutrition,['10.1093/ajcn/nqaa222']
2081,32869937,Postactivation performance enhancement: Does conditioning one arm augment performance in the other?,"The purpose was to determine whether postactivation performance enhancement is specific to the muscle being conditioned or if it is also observed within the homologous muscles of the contralateral limb (after accounting for the warm-up and random error). We also investigated whether this differed based on training status or muscle size. One hundred seven participants (75 untrained; 32 trained) participated in four sessions. Visit 1 included baseline measurements and familiarization. Visits 2-4 included the completion of one of the three experimental conditions: (a) control, (b) same side and (c) crossover completed in a randomized order. The control condition completed all testing except for the conditioning contraction. The same side condition completed the conditioning contraction on the same side as the strength test. The crossover condition completed the conditioning on the arm opposite to the strength test. The variable of interest was the change from baseline in isokinetic strength. Our analysis indicated that of the hypotheses compared, the posterior probabilities (posterior probability of 0.506) favoured the hypothesis that the effect was local and greatest in those who were resistance trained [mean (SD) of 1.4 (2.2) Nm over the control in those resistance trained]. We found no relationship between muscle size and postactivation performance enhancement. In conclusion, there is an influence of training status pertaining to the postactivation performance enhancement effect but no influence from baseline muscle size. It appears unlikely that the effect is due to a systemic mechanism.",2020,"Our analysis indicated that of the hypotheses compared, the posterior probabilities (posterior probability of 0.506) favored the hypothesis that the effect was local and greatest in those who were resistance trained [mean (SD) of 1.4 (2.2) Nm over the control in those resistance trained].",['One hundred seven participants (75 untrained; 32 trained) participated in four sessions'],[],[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]",[],[],107.0,0.0336778,"Our analysis indicated that of the hypotheses compared, the posterior probabilities (posterior probability of 0.506) favored the hypothesis that the effect was local and greatest in those who were resistance trained [mean (SD) of 1.4 (2.2) Nm over the control in those resistance trained].","[{'ForeName': 'Vickie', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Bell', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Spitz', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Ricardo B', 'Initials': 'RB', 'LastName': 'Viana', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Raksha N', 'Initials': 'RN', 'LastName': 'Chatakondi', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Loenneke', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, Kevser Ermin Applied Physiology Laboratory, The University of Mississippi, University, MS, USA.'}]",Clinical physiology and functional imaging,['10.1111/cpf.12659']
2082,32869956,"Impact of a weight loss and fitness intervention on exercise-associated plasma oxylipin patterns in obese, insulin-resistant, sedentary women.","Very little is known about how metabolic health status, insulin resistance or metabolic challenges modulate the endocannabinoid (eCB) or polyunsaturated fatty acid (PUFA)-derived oxylipin (OxL) lipid classes. To address these questions, plasma eCB and OxL concentrations were determined at rest, 10 and 20 min during an acute exercise bout (30 min total, ~45% of preintervention V̇O 2peak  , ~63 W), and following 20 min recovery in overnight-fasted sedentary, obese, insulin-resistant women under controlled diet conditions. We hypothesized that increased fitness and insulin sensitivity following a ~14-week training and weight loss intervention would lead to significant changes in lipid signatures using an identical acute exercise protocol to preintervention. In the first 10 min of exercise, concentrations of a suite of OxL diols and hydroxyeicosatetraenoic acid (HETE) metabolites dropped significantly. There was no increase in 12,13-DiHOME, previously reported to increase with exercise and proposed to activate muscle fatty acid uptake and tissue metabolism. Following weight loss intervention, exercise-associated reductions were more pronounced for several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME were reduced. These findings suggest that improved metabolic health modifies soluble epoxide hydrolase, cytochrome P450 epoxygenase (CYP), and lipoxygenase (LOX) systems. Acute exercise led to reductions for most eCB metabolites, with no evidence for concentration increases even at recovery. It is proposed that during submaximal aerobic exercise, nonoxidative fates of long-chain saturated, monounsaturated, and PUFAs are attenuated in tissues that are important contributors to the blood OxL and eCB pools.",2020,"Following weight loss intervention, exercise-associated reductions were more pronounced for several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME were reduced.","['obese, insulin-resistant, sedentary women']",['weight loss and fitness intervention'],"['fitness and insulin sensitivity', 'plasma eCB and OxL concentrations', 'activate muscle fatty acid uptake and tissue metabolism', 'concentrations of a suite of OxL diols and hydroxyeicosatetraenoic acid (HETE) metabolites', 'several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020349', 'cui_str': 'Hydroxyeicosatetraenoic acid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0220871', 'cui_str': 'linoleate'}, {'cui': 'C1370209', 'cui_str': 'Alpha linolenate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0529124,"Following weight loss intervention, exercise-associated reductions were more pronounced for several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME were reduced.","[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Grapov', 'Affiliation': 'CDS-Creative Data Solutions, Davis, CA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Fiehn', 'Affiliation': 'West Coast Metabolomics Center, University of California, Davis, CA, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Chandler', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Burnett', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Souza', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Casazza', 'Affiliation': 'Department of Kinesiology, California State University, Sacramento, CA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Hunter', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Hoppel', 'Affiliation': 'Pharmacology Department, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Harper', 'Affiliation': 'Department of Biochemistry, Microbiology and Immunology, and Ottawa Institute of Systems Biology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Sean H', 'Initials': 'SH', 'LastName': 'Adams', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, AR, USA.""}]",Physiological reports,['10.14814/phy2.14547']
2083,32876791,A comparison of ice wrap and subacromial injection for postoperative pain and edema control following arthroscopic rotator cuff repair.,"BACKGROUND


Postoperative pain and edema are the most common problems associated with arthroscopic rotator cuff repair. The purpose of the present study was to compare ice wrap and subacromial injection (SI) as treatments for early postop pain and edema control and to contrast them with a control group.
MATERIALS AND METHODS


59 patients treated with arthroscopic rotator cuff repair were randomized into three groups: 23 patients who received an ice wrap, 20 patients who received a SI, and a control group of 16 patients.
RESULTS


Patient demographics, comorbidities, tear retraction, degree of fatty muscle degeneration, surgical procedures, and amount of irrigation fluid were similar for the three groups, which also showed similar results regarding postoperative pain and edema control as well as analgesic consumption.
CONCLUSIONS


The present study failed to show any difference in effectiveness between the two most common pain management modalities, or between those modalities and the control group.
LEVEL OF EVIDENCE


IV, prospective observational study.",2020,"The present study failed to show any difference in effectiveness between the two most common pain management modalities, or between those modalities and the control group.
","['arthroscopic rotator cuff repair', '59 patients treated with arthroscopic rotator cuff repair were randomized into three groups: 23 patients who received an ice wrap, 20 patients who received a SI, and a control group of 16 patients']","['ice wrap and subacromial injection', 'ice wrap and subacromial injection (SI']","['comorbidities, tear retraction, degree of fatty muscle degeneration, surgical procedures, and amount of irrigation fluid', 'postoperative pain and edema control']","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234958', 'cui_str': 'Muscle degeneration'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0150561', 'cui_str': 'Edema control'}]",59.0,0.0220246,"The present study failed to show any difference in effectiveness between the two most common pain management modalities, or between those modalities and the control group.
","[{'ForeName': 'Yavuz Selim', 'Initials': 'YS', 'LastName': 'Kara', 'Affiliation': 'Department of Orthopedic Surgery, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Hapa', 'Affiliation': 'Department of Orthopedic Surgery, Dokuz Eylül University, Izmir, Turkey. onurhapa@gmail.com.'}, {'ForeName': 'Yağmur', 'Initials': 'Y', 'LastName': 'Işın', 'Affiliation': 'Department of Orthopedic Surgery, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Ali İhsan', 'Initials': 'Aİ', 'LastName': 'Kılıç', 'Affiliation': 'Department of Orthopedic Surgery, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Havitçioğlu', 'Affiliation': 'Department of Orthopedic Surgery, Dokuz Eylül University, Izmir, Turkey.'}]",Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology,['10.1186/s10195-020-00556-6']
2084,32871473,Sirolimus versus cyclosporine for the treatment of pediatric chronic immune thrombocytopenia: A randomized blinded trial.,"INTRODUCTION


Chronic immune thrombocytopenia (ITP) of childhood is still a problem. For treating ITP, several immunosuppressive medications can be considered with various response rates. Our goal was to compare effects of sirolimus and cyclosporine on children with chronic ITP.
METHODS


This randomized and blinded trial was carried out on 67 children over 5 years old with chronic ITP. Patients were assigned 1:1 to cyclosporine and sirolimus for 6 months. Platelet count was assessed and compared between 2 study groups at different intervals. The clinical trial registry number was IRCT20180501039499N1.
RESULTS


Sixty-one children completed the 6-month treatment. Mean age was 9.3 years with an excess of females. Compared to baseline values, both drugs caused a significant increase in number of platelets over the course of treatment; sirolimus group: 15,800/mcL vs 96,566/mcL, (P < 0.001), cyclosporine group: 14,400/mcL vs 111,266/mcL, P < 0.001,). In addition, differences of platelet number were statistically significant at some treatment intervals (3rd and 6th month, P < 0.05). A quicker response was observed in children receiving cyclosporine. Both drugs had similar rate of response which occurred in 50% of included patients. Finally, sirolimus had a better safety profile.
CONCLUSIONS


Our study showed that cyclosporine and sirolimus had an equal rate of response in treating chronic ITP of children. At the same time, the two medications showed significant differences in their side effects.",2020,"Compared to baseline values, both drugs caused a significant increase in number of platelets over the course of treatment; sirolimus group: 15,800/mcL vs 96,566/mcL, (P < 0.001), cyclosporine group: 14,400/mcL vs 111,266/mcL, P < 0.001,).","['67 children over 5\xa0years old with chronic ITP', 'pediatric chronic immune thrombocytopenia', 'children with chronic ITP', 'Mean age was 9.3\xa0years with an excess of females']","['sirolimus and cyclosporine', 'cyclosporine and sirolimus', 'sirolimus', 'cyclosporine', 'Sirolimus versus cyclosporine']","['platelet number', 'number of platelets', 'safety profile', 'side effects', 'Platelet count']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",67.0,0.0888878,"Compared to baseline values, both drugs caused a significant increase in number of platelets over the course of treatment; sirolimus group: 15,800/mcL vs 96,566/mcL, (P < 0.001), cyclosporine group: 14,400/mcL vs 111,266/mcL, P < 0.001,).","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Mousavi-Hasanzadeh', 'Affiliation': 'Student Research Committee, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Bahador', 'Initials': 'B', 'LastName': 'Bagheri', 'Affiliation': 'Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Pharmacology, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Mehrabi', 'Affiliation': 'Student Research Committee, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Aygin', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': 'Students Research Committee, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': 'Ali Asghar Clinical Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: eghbali.a@iums.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106895']
2085,32872052,Image quality and clinical usefulness of automatic tube current modulation technology in female chest computed tomography screening.,"The study was aimed to evaluate the image quality and radiation dose during female chest computed tomography (CT) screening using organ-based tube current modulation technology X-ray combined applications to reduce exposure (XCARE).Five hundred sixty female individuals undergoing chest CT scan were prospectively enrolled and divided into 4 groups based on body mass index (BMI). Then they were randomly and equally divided into control and experimental subgroup and respectively accepted conventional low-dose and XCARE technology spiral CT scan with same parameters. Signal-to-noise ratio and contrast-to-noise ratio were calculated. The quality of the images was evaluated by 2 radiologists using a 5-point scale.Among experimental subgroups of the 4 BMI groups, Signal-to-noise ratios, CT dose index of volume, dose-length product, effective dose, and contrast-to-noise ratio all displayed significant differences, as well as in control subgroups (P < .001). Both the experimental and control subgroups showed an increasing trend in radiation dose with the increasing of BMI. Parameters of image quality and radiation dose displayed no significant differences between control and experimental subgroups in the 4 groups. In multiple linear regression analysis, age and scanning protocol were not associated with radiation dose (P > .05), while BMI was significantly associated with increased CT dose index of volume (P < .05). The display of the lesions for the patients in the control and experimental subgroups of the 4 groups with different BMIs exhibited no statistically significant difference.The same image quality and radiation dose can be obtained using XCARE technology compared to conventional chest CT scans, which can be used regularly in female patients.Advances in knowledge: Using automatic tube current modulation technology to reduce exposure in breast. In this study, we sought a radiation protection method for sensitive tissue in chest CT screening.",2020,"In multiple linear regression analysis, age and scanning protocol were not associated with radiation dose (P > .05), while BMI was significantly associated with increased CT dose index of volume (P < .05).","['female patients', 'XCARE).Five hundred sixty female individuals undergoing chest CT scan', 'female chest computed tomography screening']","['female chest computed tomography (CT) screening using organ-based tube current modulation technology X-ray combined applications', 'automatic tube current modulation technology', 'conventional low-dose and XCARE technology spiral CT scan']","['Signal-to-noise ratio and contrast-to-noise ratio', 'Signal-to-noise ratios, CT dose index of volume, dose-length product, effective dose, and contrast-to-noise ratio', 'BMI', 'CT dose index of volume']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0860888', 'cui_str': 'Spiral computed tomography scan'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0106629,"In multiple linear regression analysis, age and scanning protocol were not associated with radiation dose (P > .05), while BMI was significantly associated with increased CT dose index of volume (P < .05).","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'aDepartment of Radiology, Huadong Hospital Affiliated to Fudan University bInstitute of Functional and Molecular Medical Imaging, Fudan University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Lukai', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021719']
2086,32872064,Effectiveness of nurse-led program on mental health status and quality of life in patients with chronic heart failure.,"Current study was to evaluate the effectiveness of nurse-led program in improving mental health status (MHS) and quality of life (QOL) in chronic heart failure (CHF) patients after an acute exacerbation. CHF patients were enrolled after informed consent was obtained and were assigned into the control and treatment group. Patients in the control group received standard care. In the treatment group, patients received standard care plus telehealth intervention including inquiring patients medical condition, providing feedbacks, counseling patients, and having positive and emotional talk with patients. At the third and sixth month after discharge, participants were called by registered nurses to assess Mental Health Inventory-5 (MHI-5) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Compared to the treatment group, patients in the control group were less likely to have educational attainment ≥ high school degree and have a married status, but were more likely to have diabetes. No significant differences in MHI-5 (68.5 ± 12.7 vs 66.9 ± 10.4) and KCCQ (70.6 ± 12.2 vs 68.7 ± 10.9) scores at baseline between the control and treatment groups were observed. There were significantly differences in MHI-5 (72.7 ± 15.6 vs 65.2 ± 11.4) and KCCQ score (74.2 ± 14.9 vs 66.4 ± 12.1) at 3 months follow-up between control and treatment groups. Nonetheless, at 6 months follow-up, although MHI-5 and KCCQ scores remained higher in the treatment group, there were no statistically significant differences (MHI-5: 65.4 ± 12.8 vs 61.4 ± 10.0; KCCQ: 65.1 ± 12.3 vs 61.9 ± 10.3). After multivariate regression analysis, not receiving nurse-led program were significantly associated with reduced MHI-5 (odds ratio [OR] 1.25% and 95% confidence interval [CI]: 1.14-1.60) and KCCQ (OR: 1.20% and 95% CI:1.11-1.54) scores. Nurse-led program is helpful to improve MHS and QOL in CHF patients after an acute exacerbation. However, these achievements are attenuated quickly after the nurse-led intervention discontinuation.",2020,"After multivariate regression analysis, not receiving nurse-led program were significantly associated with reduced MHI-5 (odds ratio [OR] 1.25% and 95% confidence interval [CI]: 1.14-1.60) and KCCQ (OR: 1.20% and 95% CI:1.11-1.54) scores.","['CHF patients', 'patients with chronic heart failure', 'chronic heart failure (CHF) patients after an acute exacerbation']","['nurse-led program', 'standard care', 'standard care plus telehealth intervention']","['KCCQ score', 'MHI-5', 'mental health status and quality of life', 'MHI-5 and KCCQ scores', 'mental health status (MHS) and quality of life (QOL', 'Mental Health Inventory-5 (MHI-5) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores']","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0303348,"After multivariate regression analysis, not receiving nurse-led program were significantly associated with reduced MHI-5 (odds ratio [OR] 1.25% and 95% confidence interval [CI]: 1.14-1.60) and KCCQ (OR: 1.20% and 95% CI:1.11-1.54) scores.","[{'ForeName': 'Yuzhu', 'Initials': 'Y', 'LastName': 'Mo', 'Affiliation': ""aDepartment of Nursing, Hainan Western Central Hospital, Hainan bDepartment of Nursing, the Ninth People's Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai cDepartment of Cardiology, Hainan Western Central Hospital, Hainan, China.""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Guoding', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Mingzi', 'Initials': 'M', 'LastName': 'Chu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021746']
2087,32875571,Alternative nivolumab duration and scheduling in advanced nonsmall cell lung cancer: A real-world evidence.,"In advanced nonsmall cell lung cancer (aNSCLC), stopping nivolumab after 12 months negatively affects outcomes. We performed a world data-based analysis assessing the value of nivolumab continuation and optimal dosing beyond 24 months. Out of 697 consecutive patients with aNSCLC in whom nivolumab was initiated between 2015 and 2018, 45 patients receiving nivolumab for ≥24 months were selected. These were divided into Groups A: nivolumab administered at a dose 3 mg/kg q2 weeks/240 mg q2 weeks/480 mg q4 weeks, n = 25; B: nivolumab re-scheduled to a nonstandard dose 3 mg/kg q3 weeks-q8 weeks, n = 13; C: nivolumab stopped after 24 months, n = 7; (in Groups B and C-for reasons other than progressive disease or intolerable toxicity). Progression-free survival (PFS) (Revised Response Evaluation Criteria in Solid Tumors, version 1.1) and safety (Common Terminology Criteria for Adverse Events, version 4.03) were assessed. With median follow-up of 35.6 months (interquartile range 28.4-41.8), 4%, 31%, 29% and 30% of patients progressed in Groups A, B, C and B+C, respectively. PFS at 36 months since nivolumab initiation comprised 100%, 67%, 67% and 67%, in Groups A, B, C and B+C, respectively. PFS at 40 months since nivolumab initiation comprised 83%, 67%, 67% and 67%, in Groups A, B, C and B+C, respectively. Allocation to Group A vs Group B, C and B+C was associated with hazard ratio for PFS-0.20 (95% confidence interval [CI], 0.02-1.77, P-.15), 0.20 (95% CI, 0.02-2.25, P-.19) and 0.20 (95% CI, 0.02-1.66, P-.14), respectively. No differences in newly occurring or worsening adverse events between the groups were observed. A trend for worse PFS was observed with alternative nivolumab scheduling or quitting 24 months after initiation. Continuing nivolumab at a standard dose until disease progression or intolerable toxicity remains the standard treatment option.",2020,No differences in newly-occurring or worsening adverse events between the groups were observed.,"['B', '697 consecutive patients with aNSCLC in whom nivolumab was initiated between 2015-2018, 45 patients receiving nivolumab for ≥24mo were selected', 'advanced non-small cell lung cancer (aNSCLC']",['nivolumab'],"['newly-occurring or worsening adverse events', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",697.0,0.0981711,No differences in newly-occurring or worsening adverse events between the groups were observed.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dudnik', 'Affiliation': 'Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Moskovitz', 'Affiliation': 'Thoracic Cancer Service, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Abed', 'Initials': 'A', 'LastName': 'Agbarya', 'Affiliation': 'Oncology Department, Bney Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Teodor', 'Initials': 'T', 'LastName': 'Gottfried', 'Affiliation': 'Thoracic Oncology Service, Institute of Oncology, Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel.'}, {'ForeName': 'Tzippy', 'Initials': 'T', 'LastName': 'Shochat', 'Affiliation': 'Statistical Consulting Unit, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Urban', 'Affiliation': 'Thoracic Oncology Service, Institute of Oncology, Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Zer', 'Affiliation': 'Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Rotem', 'Affiliation': 'Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Yust', 'Affiliation': 'Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Peled', 'Affiliation': 'The Legacy Heritage Oncology Center, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Wollner', 'Affiliation': 'Thoracic Cancer Service, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Jair', 'Initials': 'J', 'LastName': 'Bar', 'Affiliation': 'Thoracic Oncology Service, Institute of Oncology, Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of cancer,['10.1002/ijc.33281']
2088,32870712,Randomized head-to-head comparison of minodronic acid and raloxifene for fracture incidence in postmenopausal Japanese women: the Japanese Osteoporosis Intervention Trial (JOINT)-04.,"AIMS


We conducted a head-to-head randomized trial of minodronate, a bisphosphonate, and raloxifene, a selective estrogen receptor modulator, to obtain clinical evidence and information about their efficacy and safety.
METHODS


The Japanese Osteoporosis Intervention Trial protocol number 4 (JOINT-04) trial is a multi-center, open-labeled, blinded endpoints, head-to-head randomized trial of minodronate and raloxifene. Ambulatory elderly women with osteoporosis (age, >60 years) were randomly allocated to the raloxifene or minodronate group by central registration. The co-primary endpoints included any one of osteoporotic fractures (vertebral, humeral, femoral, and radial fractures), vertebral fractures, and major osteoporotic fractures (clinical vertebral, humeral, femoral, and radial fractures). The biological effects of each drug, patients' quality of life, and drug safety were assessed based on the secondary outcomes. This study was registered at the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) under trial identification number UMIN000005433.
RESULTS


A total of 3896 patients were randomized to the minodronate and raloxifene groups, and drug efficacy assessments were performed for 3247 patients (1623 and 1624 patients, respectively). Among these patients, 1176 and 1187 patients received allocated treatment for 2 years. The incidence rate ratios for osteoporotic, vertebral, and major osteoporotic fractures in the minodronate group were 0.94 (95% CI: 0.78-1.13,  p  = .494), 0.86 (95% CI: 0.70-1.05,  p  = .147), and 1.22 (95% CI: 0.86-1.74,  p  = .274), respectively. Compared to the raloxifene group, the minodronate group showed significantly increased bone mineral density of the lumbar spine for each visit (6 months:  p  = .007, 12 months:  p  = .0003, 24 months:  p <.0001). Also, serious adverse reactions were observed for four and six patients in the minodronate and raloxifene groups, respectively.
CONCLUSIONS


Overall, there were no statistical differences in the incidence rates of osteoporotic, vertebral, or major osteoporotic fractures between the two groups. Serious adverse reactions were rare in both groups.",2020,"Overall, there were no statistical differences in the incidence rates of osteoporotic, vertebral, or major osteoporotic fractures between the two groups.","['postmenopausal Japanese women', '3896 patients', 'Ambulatory elderly women with osteoporosis (age, >60 years', '3247 patients (1623 and 1624 patients, respectively']","['minodronate and raloxifene', 'raloxifene', 'minodronic acid and raloxifene', 'bisphosphonate, and raloxifene', 'raloxifene or minodronate group by central registration']","['bone mineral density of the lumbar spine', 'osteoporotic fractures (vertebral, humeral, femoral, and radial fractures), vertebral fractures, and major osteoporotic fractures (clinical vertebral, humeral, femoral, and radial fractures', 'incidence rates of osteoporotic, vertebral, or major osteoporotic fractures', 'incidence rate ratios for osteoporotic, vertebral, and major osteoporotic fractures', 'quality of life, and drug safety', 'serious adverse reactions', 'Serious adverse reactions']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0662880', 'cui_str': 'minodronate'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",3896.0,0.0666248,"Overall, there were no statistical differences in the incidence rates of osteoporotic, vertebral, or major osteoporotic fractures between the two groups.","[{'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Department of Data Science, Biostatistics Section, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Teruki', 'Initials': 'T', 'LastName': 'Sone', 'Affiliation': 'Department of Nuclear Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Miyazaki', 'Affiliation': 'Public Health Research Foundation, Tokyo, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Tsukiyama', 'Affiliation': 'Public Health Research Foundation, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Taguchi', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, School of Dentistry, Matsumoto Dental University, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Department of Orthopaedic Surgery and Rheumatology, Nara Hospital, Kindai University, Nara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Bone and Joint Surgery, Seirei Hamamatu General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': 'School of Health Science, Tottori University faculty of Medicine, Tottori, Japan.'}, {'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Eikokai Ono Hospital, Hyogo, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Nuclear Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ohta', 'Affiliation': 'International Medical Center, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Japan Osteoporosis Foundation, Tokyo, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Orimo', 'Affiliation': 'Japan Osteoporosis Foundation, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Current medical research and opinion,['10.1080/03007995.2020.1816537']
2089,32871556,Effect of High-Intensity Interval Training Versus Small-Sided Games Training on Sleep and Salivary Cortisol Level,"PURPOSE


The authors compared sleep quality and salivary cortisol concentration after high-intensity interval training (HIIT) and small-sided games (SSGs) performed at the habitual training time in nonprofessional male soccer players.
METHODS


A total of 32 players (age = 24 [6] y, height = 1.77 [0.06] m, and body mass = 75 [12] kg) were randomized into an HIIT group or an SSG group. Actual sleep time, sleep efficiency (SE), sleep latency, immobility time (IT), moving time (MT), and fragmentation index were monitored using actigraphy before (PRE) and 2 nights after (POST 1 and POST 2) the training session. Salivary cortisol levels were measured before (PRE) and after (POST) training. Cortisol awakening response was evaluated.
RESULTS


Significant intragroup differences in the HIIT group were noted for actual sleep time (P < .0001), SE (P < .0001), sleep latency (P = .047), IT (P < .0001), MT (P < .0001), and fragmentation index (P < .0001) between PRE and POST 1 and for SE (P = .035), IT (P = .004), MT (P = .006), and fragmentation index (P = .048) between PRE and POST 2. Intergroup differences for actual sleep time (P = .014), SE (P = .048), IT (P < .0001), and MT (P = .046) were observed between the HIIT and the SSGs group at POST 1 were detected. Significant intragroup variations were observed in PRE and POST salivary cortisol levels (P < .0001 for HIIT; P = .0003 for SSGs) and cortisol awakening response (P < .0001 for HIIT; P < .0001 for SSGs). Significant intergroup differences between the HIIT and the SSGs group were found at POST (P < .0001) and in cortisol awakening response (P = .017).
CONCLUSIONS


Changes in actigraphy-based sleep parameters and salivary cortisol levels were greater after an acute session of HIIT than SSGs in this sample of nonprofessional male soccer players.",2020,"RESULTS


Significant intragroup differences in the HIIT group were noted for actual sleep time (P < .0001), SE (P < .0001), sleep latency (P = .047), IT (P < .0001), MT (P < .0001), and fragmentation index (P < .0001) between PRE and POST 1 and for SE (P = .035)","['32 players (age = 24 [6', 'nonprofessional male soccer players']","['High-Intensity Interval Training Versus Small-Sided Games Training', 'SSG', 'high-intensity interval training (HIIT) and small-sided games (SSGs']","['Actual sleep time, sleep efficiency (SE), sleep latency, immobility time (IT), moving time (MT), and fragmentation index', 'cortisol awakening response', 'SE', 'sleep quality and salivary cortisol concentration', 'salivary cortisol levels', 'Salivary cortisol levels', 'Cortisol awakening response', 'sleep latency', 'PRE and POST salivary cortisol levels', 'actual sleep time', 'fragmentation index', 'Sleep and Salivary Cortisol Level']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0231441', 'cui_str': 'Immobile'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.034567,"RESULTS


Significant intragroup differences in the HIIT group were noted for actual sleep time (P < .0001), SE (P < .0001), sleep latency (P = .047), IT (P < .0001), MT (P < .0001), and fragmentation index (P < .0001) between PRE and POST 1 and for SE (P = .035)","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonato', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': ''}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Marventano', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Saresella', 'Affiliation': ''}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Merati', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Banfi', 'Affiliation': ''}, {'ForeName': 'Jacopo A', 'Initials': 'JA', 'LastName': 'Vitale', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0498']
2090,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
2091,32890855,Reading proficiency influences the effects of transcranial direct current stimulation: Evidence from selective modulation of dorsal and ventral pathways of reading in bilinguals.,"INTRODUCTION


tDCS can modulate reading which is processed by lexical (ventral) and sub-lexical (dorsal) pathways. Previous research indicates that pathway recruitment in bilinguals depends on a script's orthographic depth and a reader's proficiency with it. The effect of tDCS on each reading pathway has not been investigated in bilinguals. We stimulated the left dorsal and ventral pathways separately in Chinese-English (C-E) bilinguals to understand whether pathway-specific modulation by tDCS is possible and, if so, how it is influenced by orthographic depth and script proficiency.
METHODS


A double-blind, sham-controlled, within-subject experiment was designed wherein 16 balanced bilinguals received anodal tDCS in dorsal, ventral and sham sessions. Two tDCS montages of electrode sizes 5 × 5 cm 2  with 1) anode at CP5 and cathode at CZ, and 2) anode at TP7 and cathode at nape of the neck, were applied for stimulating the dorsal and ventral pathways respectively. Bilinguals were asked to read word lists for each language before and after stimulation. RTs for accurate trials were analysed using linear mixed-effect modelling that included proficiency scores for reading English pseudo-words (PW) and Chinese pinyin.
RESULTS


For both languages, word reading RTs were faster following dorsal pathway stimulation. The dorsal stimulation effect (change in RT) was negatively correlated with pseudoword reading and pinyin proficiency. Stimulation of the ventral pathway decreased RTs only for Chinese reading.
CONCLUSION


Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading. Dorsal pathway tDCS effects are modulated by sub-lexical reading proficiency.",2020,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,[],"['anodal tDCS', 'tDCS']",['dorsal stimulation effect (change in RT'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0476543,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,"[{'ForeName': 'Sagarika', 'Initials': 'S', 'LastName': 'Bhattacharjee', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Kashyap', 'Affiliation': 'Centre for Research and Development in Learning (CRADLE), Singapore.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': ""O'Brien"", 'Affiliation': 'Centre for Research in Child Development (CRCD), National Institute of Education, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCloskey', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Oishi', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Desmond', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Rapp', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States. Electronic address: brapp1@jhu.edu.'}, {'ForeName': 'S H Annabel', 'Initials': 'SHA', 'LastName': 'Chen', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore; Centre for Research and Development in Learning (CRADLE), Singapore; Lee Kong Chian School of Medicine (LKC Medicine), Nanyang Technological University, Singapore. Electronic address: annabelchen@ntu.edu.sg.'}]",Brain and language,['10.1016/j.bandl.2020.104850']
2092,32890862,Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders.,"The implementation of evidence-based psychological treatments (EBPTs) may be particularly challenging to accomplish in community mental health settings for individuals with severe mental illness (SMI). Transdiagnostic treatments, or treatments that target a mechanism that underpins multiple mental health problems, may be particularly well-suited to community mental health settings. This study examines community stakeholder perspectives (N = 22) of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) implemented in a community mental health setting in the context of a randomized controlled trial of TranS-C for SMI. The present study aimed to identify barriers and facilitators to the implementation of TranS-C for SMI in a community mental health setting using (1) a deductive theory-based process based on the Framework for Dissemination in Health Services Intervention Research and (2) an inductive thematic analysis process. All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting. Seven additional themes were identified through the inductive thematic analysis. A discussion of how the findings are related to prior research, other EBPT implementation, and future TranS-C implementation are included.",2020,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,['individuals with severe mental illness (SMI'],"['Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'transdiagnostic sleep and circadian intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0372757,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,"[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States; Department of Psychology, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States. Electronic address: aharvey@berkeley.edu.'}]",Psychiatry research,['10.1016/j.psychres.2020.113443']
2093,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
2094,32876987,Efficacy of oral supplementation of whey protein in patients with contact dermatitis: A pilot randomized double-blind placebo-controlled clinical trial.,"Whey protein is a popular dietary product that has numerous health benefits such as immune modulation. In this study, we assessed efficacy of whey protein in management of patients with contact dermatitis (CD) through a double blind, randomized controlled clinical trial in Emam Reza clinic, Shiraz, Iran. Twenty-five patients in each group were randomly assigned to receive whey protein or placebo powder, 30 g in 200 mL warm water at fasting time for 4 weeks. Outcome measures were Dermatology Life Quality Index (DLQI) questionnaire and the Eczema Area and Severity Index (EASI) score. Furthermore, subjective total improvement (assessed by visual analogue scale) was set as the other primary outcome measure. A significant decrease was observed in the scores of EASI, DLQI, and subjective total improvement in the drug group after the intervention compared with the baseline. However, no changes were seen in the placebo group. Moreover, there was a significant reduction in the scores of EASI (P = .002) and subjective total improvement scores (P = .039) over the study period in the drug group compared with the placebo group. According to the results of this study, it seems that oral supplementation of whey protein could improve the symptoms of CD compared with placebo.",2020,"A significant decrease was observed in the scores of EASI, DLQI and subjective total improvement in the drug group after the intervention compared to the baseline.","['patients with contact dermatitis', 'Twenty-five patients in each group', 'patients with contact dermatitis through a double blind, randomized controlled clinical trial in Emam Reza clinic, Shiraz, Iran']","['whey protein', 'oral supplementation of whey protein', 'placebo', 'whey protein or placebo powder']","['Dermatology Life Quality Index (DLQI) questionnaire and the Eczema Area and Severity Index (EASI) score', 'symptoms of contact dermatitis', 'scores of EASI', 'subjective total improvement scores', 'subjective total improvement (assessed by visual analogue scale', 'scores of EASI, DLQI and subjective total improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011616', 'cui_str': 'Contact dermatitis'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011616', 'cui_str': 'Contact dermatitis'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.33237,"A significant decrease was observed in the scores of EASI, DLQI and subjective total improvement in the drug group after the intervention compared to the baseline.","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Alyasin', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyed Hesamedin', 'Initials': 'SH', 'LastName': 'Nabavizadeh', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyed Taghi', 'Initials': 'ST', 'LastName': 'Heydari', 'Affiliation': 'Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyed Hamdollah', 'Initials': 'SH', 'LastName': 'Mosavat', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Parvizi', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyyed Mohammad', 'Initials': 'SM', 'LastName': 'Hashemi', 'Affiliation': 'Allergy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hashem', 'Initials': 'MH', 'LastName': 'Hashempur', 'Affiliation': 'Noncommunicable Diseases Research Center, Fasa University of Medical Sciences, Fasa, Iran.'}]",Dermatologic therapy,['10.1111/dth.14260']
2095,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
2096,32872077,A clinical study of Yiqi Huayu Jiedu decoction reducing the risk of postoperative gastric cancer recurrence and metastasis: Study protocol for a randomized controlled trail.,"BACKGROUND


Gastric cancer is a common gastrointestinal tumor, seriously threatening human health. Radical surgery is the preferred treatment for gastric cancer. However, due to the late diagnosis and postoperative recurrence and metastasis, the prognosis is dismal. In China, traditional Chinese medicine (TCM) has been used to treat gastric cancer for many years. The purpose of this study is to explore the efficacy and safety of Yiqi Huayu Jiedu decoction in the treatment of postoperative gastric caner.
METHODS/DESIGN


226 eligibility patients altogether will be randomly allocated to the treatment group and the control group at a ratio of 1:1. After enrollment, every patients will obtain 6 months of treatment, as well as 2 years of follow-up. At the end of this study, primary outcomes including 1-year progression-free survival rate, 2-year progression-free survival rate and disease-free survival, secondary outcomes containing tumor markers, TCM syndrome points, quality of life scale, imageological examination and the safety indicators will be assessed.
DISCUSSION


This study will provide the evidence-based evidence for the efficacy of Yiqi Huayu Jiedu decoction reducing the risk of postoperative gastric cancer recurrence and metastasis, which will be beneficial to form the therapeutic regimen in postoperative gastric cancer with integrated TCM and Western medicine.
TRAIL REGISTRATION


ChiCTR2000032802.",2020,"This study will provide the evidence-based evidence for the efficacy of Yiqi Huayu Jiedu decoction reducing the risk of postoperative gastric cancer recurrence and metastasis, which will be beneficial to form the therapeutic regimen in postoperative gastric cancer with integrated TCM and Western medicine.
","['gastric cancer', '226 eligibility patients altogether']","['Yiqi Huayu Jiedu decoction', 'traditional Chinese medicine (TCM', 'Radical surgery']","['efficacy and safety', 'postoperative gastric cancer recurrence and metastasis', '1-year progression-free survival rate, 2-year progression-free survival rate and disease-free survival, secondary outcomes containing tumor markers, TCM syndrome points, quality of life scale, imageological examination and the safety indicators will be assessed']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",226.0,0.0838229,"This study will provide the evidence-based evidence for the efficacy of Yiqi Huayu Jiedu decoction reducing the risk of postoperative gastric cancer recurrence and metastasis, which will be beneficial to form the therapeutic regimen in postoperative gastric cancer with integrated TCM and Western medicine.
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'aThe Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine bNo.1 Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China cNanjing Drum Tower Hospital.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Mengjun', 'Initials': 'M', 'LastName': 'Nie', 'Affiliation': ''}, {'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Shenlin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Ruiping', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021775']
2097,32872078,"A randomized, double-blind, placebo-controlled trial for Yi-Qi Hua-Yu tong-sui granule in the treatment of mild or moderate cervical spondylotic myelopathy.","BACKGROUND


Neck pain, sensory disturbance and motor dysfunction in most patients suffered cervical spondylotic myelopathy (CSM). However, some conservative treatments are limited by their modest effectiveness. In the other hand, surgical treatment is necessary when symptoms are refractory to conservative treatments and neurological function of the patients has deteriorated. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Yiqi-Huayu-Tongsui (YQHYTS) granule, a compound traditional Chinese herbal medicine, on symptoms in patients with mild or moderate CSM.
METHODS/DESIGN


A randomized, double blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of YQHYTS granule is proposed. 72 patients in Longhua Hospital with the diagnosis of mild or moderate CSM will be randomly allocated into 2 groups, and treated with YQHYTS granule or placebo. The prescription of the trial drugs (YQHYTS granule/placebo) is 20 grams twice a day for 3 months. The primary outcome measurements include visual analog scale, Japanese Orthopedic Association, and Neck Disability Index score. The secondary outcome measurements are electromyogram and Pfirrmann classification.
DISCUSSION


YQHYTS granule has been established and applied in Longhua Hospital for many years. As it has a potential benefit in treating mild or moderate CSM, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later. If YQHYTS granule can alleviate neck pain, sensory disturbance, and even motor dysfunction without adverse effects, it may be a unique strategy for the treatment of mild or moderate CSM.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ID: ChiCTR1900028192. Registered 15 December 2019, Available at: http://www.chictr.org.cn/edit.aspx?pid=46913&htm=4.",2020,"If YQHYTS granule can alleviate neck pain, sensory disturbance, and even motor dysfunction without adverse effects, it may be a unique strategy for the treatment of mild or moderate CSM.
","['72 patients in Longhua Hospital with the diagnosis of mild or moderate CSM', 'patients suffered cervical spondylotic myelopathy (CSM', 'patients with mild or moderate CSM', 'mild or moderate cervical spondylotic myelopathy']","['YQHYTS granule or placebo', 'drugs (YQHYTS granule/placebo', 'placebo', 'Yiqi-Huayu-Tongsui (YQHYTS) granule, a compound traditional Chinese herbal medicine']","['visual analog scale, Japanese Orthopedic Association, and Neck Disability Index score', 'electromyogram and Pfirrmann classification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0044729', 'cui_str': 'Dehydrocorticosterone'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",,0.468698,"If YQHYTS granule can alleviate neck pain, sensory disturbance, and even motor dysfunction without adverse effects, it may be a unique strategy for the treatment of mild or moderate CSM.
","[{'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Zhengyi', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Junming', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021776']
2098,32875505,Impact of Clinical Decision Support on Antibiotic Prescribing for Acute Respiratory Infections: a Cluster Randomized Implementation Trial.,"BACKGROUND


Clinical decision support (CDS) is a promising tool for reducing antibiotic prescribing for acute respiratory infections (ARIs).
OBJECTIVE


To assess the impact of previously effective CDS on antibiotic-prescribing rates for ARIs when adapted and implemented in diverse primary care settings.
DESIGN


Cluster randomized clinical trial (RCT) implementing a CDS tool designed to guide evidence-based evaluation and treatment of streptococcal pharyngitis and pneumonia.
SETTING


Two large academic health system primary care networks with a mix of providers.
PARTICIPANTS


All primary care practices within each health system were invited. All providers within participating clinic were considered a participant. Practices were randomized selection to a control or intervention group.
INTERVENTIONS


Intervention practice providers had access to an integrated clinical prediction rule (iCPR) system designed to determine the risk of bacterial infection from reason for visit of sore throat, cough, or upper respiratory infection and guide evidence-based evaluation and treatment.
MAIN OUTCOME(S)


Change in overall antibiotic prescription rates.
MEASURE(S)


Frequency, rates, and type of antibiotics prescribed in intervention and controls groups.
RESULTS


33 primary care practices participated with 541 providers and 100,573 patient visits. Intervention providers completed the tool in 6.9% of eligible visits. Antibiotics were prescribed in 35% and 36% of intervention and control visits, respectively, showing no statistically significant difference. There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
CONCLUSIONS


The iCPR tool was not effective in reducing antibiotic prescription rates for upper respiratory infections in diverse primary care settings. This has implications for the generalizability of CDS tools as they are adapted to heterogeneous clinical contexts.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT02534987). Registered August 26, 2015 at https://clinicaltrials.gov.",2020,"There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
","['All primary care practices within each health system were invited', '33 primary care practices participated with 541 providers and 100,573 patient visits', 'Acute Respiratory Infections', 'Two large academic health system primary care networks with a mix of providers']","['Intervention practice providers had access to an integrated clinical prediction rule (iCPR) system designed to determine the risk of bacterial infection from reason for visit of sore throat, cough, or upper respiratory infection and guide evidence-based evaluation and treatment']","['antibiotic prescription rates', 'overall antibiotic prescription rates', 'Antibiotics', 'rates of orders for rapid streptococcal tests']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179496', 'cui_str': 'Clinical Prediction Rule'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1868901', 'cui_str': 'Rapid streptococcal test'}]",,0.170395,"There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
","[{'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'New York University School of Medicine, New York, NY, USA. Devin.Mann@nyulangone.org.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McGinn', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Safiya', 'Initials': 'S', 'LastName': 'Richardson', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Palmisano', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Sara Kuppin', 'Initials': 'SK', 'LastName': 'Chokshi', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mishuris', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McCullagh', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dinh-Le', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feldstein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06096-3']
2099,32875927,"Past Sodium Intake, Contemporary Sodium Intake, and Cardiometabolic Health in Southwest Coastal Bangladesh.","Background We compared the relationship of past and contemporary sodium (Na) intake with cardiometabolic biomarkers. Methods and Results A total of 1191 participants' data from a randomized controlled trial in coastal Bangladesh were analyzed. Participants provided 24-hour urine Na (24UNa) data for 5 monthly visits. Their fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein, blood pressure, and 24-hour urine protein were measured at the fifth visit. Participants' mean 24UNa over the first 4 visits was the past Na, and 24UNa of the fifth visit was the contemporary Na intake. We estimated the prevalence ratios of elevated cardiometabolic biomarkers and metabolic syndrome across 24UNa tertiles by multilevel logistic regression using participant-, household-, and community-level random intercepts. Models were adjusted for age, sex, body mass index, smoking, physical activity, alcohol consumption, sleep hours, religion, and household wealth. Compared with participants in tertile 1 of past urine Na, those in tertile 3 had 1.46 (95% CI, 1.08-1.99) times higher prevalence of prediabetes or diabetes mellitus, 5.49 (95% CI, 2.73-11.01) times higher prevalence of large waist circumference, and 1.60 (95% CI, 1.04-2.46) times higher prevalence of metabolic syndrome. Compared with participants in tertile 1 of contemporary urine Na, those in tertile 3 had 1.93 (95% CI, 1.24-3.00) times higher prevalence of prediabetes or diabetes mellitus, 3.14 (95% CI, 1.45-6.83) times higher prevalence of proteinuria, and 2.23 (95% CI, 1.34-3.71) times higher prevalence of large waist circumference. Conclusions Both past and contemporary Na intakes were associated with higher cardiometabolic disease risk.",2020,"Their fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein, blood pressure, and 24-hour urine protein were measured at the fifth visit.","[""1191 participants' data from a randomized controlled trial in coastal Bangladesh"", 'Southwest Coastal Bangladesh']",[],"['large waist circumference', 'fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein, blood pressure, and 24-hour urine protein', '24-hour urine Na (24UNa) data', 'prevalence of prediabetes or diabetes mellitus']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]",[],"[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1254855', 'cui_str': 'Protein urine 24 hour'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",1191.0,0.0770337,"Their fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein, blood pressure, and 24-hour urine protein were measured at the fifth visit.","[{'ForeName': 'Abu Mohd', 'Initials': 'AM', 'LastName': 'Naser', 'Affiliation': 'Emory Global Diabetes Research Center Hubert Department of Global Health Rollins School of Public HealthEmory University Atlanta GA.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease ResearchBangladesh (icddr,b) Dhaka Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease ResearchBangladesh (icddr,b) Dhaka Bangladesh.'}, {'ForeName': 'Solaiman', 'Initials': 'S', 'LastName': 'Doza', 'Affiliation': 'International Centre for Diarrhoeal Disease ResearchBangladesh (icddr,b) Dhaka Bangladesh.'}, {'ForeName': 'Shahjada', 'Initials': 'S', 'LastName': 'Selim', 'Affiliation': 'Department of Endocrinology Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh.'}, {'ForeName': 'Monjila', 'Initials': 'M', 'LastName': 'Chaity', 'Affiliation': 'Carle Foundation Hospital Urbana IL.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Division of Infectious Diseases and Geographic MedicineStanford University Stanford CA.'}, {'ForeName': 'Shuchi', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'Division of Nephrology School of Medicine Stanford University Stanford CA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Staimez', 'Affiliation': 'Emory Global Diabetes Research Center Hubert Department of Global Health Rollins School of Public HealthEmory University Atlanta GA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Clasen', 'Affiliation': 'Gangarosa Department of Environmental Health Sciences Rollins School of Public HealthEmory University Atlanta GA.'}, {'ForeName': 'Unjali P', 'Initials': 'UP', 'LastName': 'Gujral', 'Affiliation': 'Emory Global Diabetes Research Center Hubert Department of Global Health Rollins School of Public HealthEmory University Atlanta GA.'}, {'ForeName': 'Matthew O', 'Initials': 'MO', 'LastName': 'Gribble', 'Affiliation': 'Gangarosa Department of Environmental Health Sciences Rollins School of Public HealthEmory University Atlanta GA.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Emory Global Diabetes Research Center Hubert Department of Global Health Rollins School of Public HealthEmory University Atlanta GA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014978']
2100,32871530,Efficacy of light therapy for a college student sample with non-seasonal subthreshold depression: An RCT study.,"BACKGROUND


Light therapy has been successfully used to treat seasonal and non-seasonal depression, but there is limited evidence for its efficacy in subthreshold depression. This study examines the efficacy of light therapy for symptoms of depression and anxiety in non-seasonal subthreshold depression.
METHODS


College students with non-seasonal subthreshold depression were recruited. The participants were randomly allocated to one of the three conditions: high- (LT-5000 lux) and low-intensity (LT-500 lux) light therapy conditions and a waiting-list control condition (WLC). The primary outcome was Hamilton Depression Rating Scale (HAMD), and secondary outcomes were Beck Depression Inventory-II (BDI-II) and state anxiety inventory (SAI), which were assessed at baseline (Week 0), during the trial (Week 4), and after completion of the light therapy (Week 8).
RESULTS


A total of 142 participants completed the trial. The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition. For the LT-5000, LT-500, and WLC conditions by the end of the 8-week trial, a response on the HAMD was achieved by 70.0%, 42.0% and 19.0% of the participants, and remission was achieved by 76.0%, 54.0%, and 19.0%, respectively.
LIMITATIONS


The subjects were not followed up regularly after completion of the trial.
CONCLUSION


Light therapy, both at high- and low-intensity, was efficacious in the treatment of college students with non-seasonal subthreshold depression. High-intensity light therapy was superior to low-intensity light therapy by the end of an 8-week trial.",2020,"The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition.","['142 participants completed the trial', 'college students with non-seasonal subthreshold depression', 'College students with non-seasonal subthreshold depression were recruited', 'college student sample with non-seasonal subthreshold depression']","['High-intensity light therapy', 'high- (LT-5000 lux) and low-intensity (LT-500 lux) light therapy conditions and a waiting-list control condition (WLC', 'light therapy']","['HAMD', 'remission', 'LT-500 conditions', 'Hamilton Depression Rating Scale (HAMD), and secondary outcomes were Beck Depression Inventory-II (BDI-II) and state anxiety inventory (SAI']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0521113', 'cui_str': 'Non-seasonal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",142.0,0.100785,"The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition.","[{'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Imaging Center, First Affiliated Hospital of Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Kwok-Fai', 'Initials': 'KF', 'LastName': 'So', 'Affiliation': 'Guangdong-Hongkong-Macau Institute of CNS Regeneration, Ministry of Education CNS Regeneration Collaborative Joint Laboratory, Jinan University, Guangzhou 510632, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510530, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong 226001, China.'}, {'ForeName': 'Chaoran', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Guangdong-Hongkong-Macau Institute of CNS Regeneration, Ministry of Education CNS Regeneration Collaborative Joint Laboratory, Jinan University, Guangzhou 510632, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510530, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong 226001, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tao', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China. Electronic address: taoqian16@jnu.edu.cn.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.055']
2101,32871534,Neurocognitive performance of repeated versus single intravenous subanesthetic ketamine in treatment resistant depression.,"BACKGROUND


Ketamine demonstrated rapid antidepressant effects in treatment-resistant depression (TRD). However, evaluation of ketamine's neurocognitive effect in TRD is unclear. We aim to (1) characterize baseline neurocognitive performance as a predictor of the change in severity of depressive symptoms over time, and (2) investigate the association of six versus single intravenous (IV) ketamine and neurocognitive changes from baseline to the end of treatment.
METHODS


Subjects with TRD were randomized to receive either five IV midazolam followed by a single IV ketamine or six IV ketamine during a 12-day period. Depression symptom assessments occurred prior and 24 h after infusion days using the Montgomery-Åsberg Depression Rating Scale. Neurocognitive tasks were designed to test attention, memory, speed of processing, and set shifting using the CogState battery at baseline and at the end of treatment.
RESULTS


Better complex working memory at baseline predicted improvement in MADRS scores of ketamine (vs midazolam) after 5 infusions. Most, but not all, neurocognitive functions remained stable or improved after repeated or single ketamine. There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group. These cognitive improvements from baseline to the end of treatment were robust when controlling for age and changes in depression severity.
CONCLUSION


The study suggests that six IV ketamine compared to single IV ketamine has a mood independent procognitive effect among TRD patients. Large scale studies are needed to confirm whether ketamine enhances cognitive function in TRD.",2020,"There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group.","['Subjects with TRD', 'TRD patients']","['Ketamine', 'single intravenous (IV) ketamine', 'ketamine', 'subanesthetic ketamine', 'ketamine or six IV ketamine', 'midazolam']","['speed of processing, set shifting, and spatial working memory', 'neurocognitive functions', 'Montgomery-Åsberg Depression Rating Scale', 'MADRS scores', 'Neurocognitive performance', 'Depression symptom assessments']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.07502,"There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group.","[{'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Shiroma', 'Affiliation': 'Geriatric Psychiatrist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA. Electronic address: paulo.shiroma@va.gov.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': 'Statistician/Research Methodologist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor/Research Associate, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wels', 'Affiliation': 'Staff Anesthesiologist, Minneapolis VA Health Care System, Mental Health Service Line; and Clinical Instructor, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'C Sophia', 'Initials': 'CS', 'LastName': 'Albott', 'Affiliation': 'Assistant Professor, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Erbes', 'Affiliation': 'Staff Psychologist, Minneapolis VA Health Care System, Mental Health Service Line; and Associate Professor of Psychiatry, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Tye', 'Affiliation': 'Senior Research Fellow, Queensland Brain Institute, The University of Queensland, Queensland, Australia; Assistant Professor Psychiatry, Psychology and Pharmacology Translational Neuroscience Laboratory, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Drs. T.J. and Ella M. Arneson Land-Grant Chair in Human Behavior, Professor of Psychiatry, Vice Chair for Research Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.058']
2102,32871535,Effect of adjunctive pimavanserin on suicidal ideation in patients with major depression: Analysis of the CLARITY study.,"BACKGROUND


Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up to 2% complete suicide. This was a post-hoc analysis aimed to evaluate the risk of suicide ideation and behavior associated with adjunctive pimavanserin treatment in adults with MDD.
METHODS


CLARITY was a randomized, double-blind, placebo-controlled study in patients with MDD and an inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). For this post-hoc analysis, the primary endpoint was mean change from baseline for HAMD item 3 (suicide). The incidence of suicidal ideation or behavior was also assessed from the Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events.
RESULTS


During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431). At any post-baseline assessment, suicidal ideation on the C-SSRS was reported in 28 (18.1%) of patients with placebo and 9 (17.3%) with pimavanserin during Stage 1 and in 7 (20.7%) with placebo and 4 (13.8%) with pimavanserin during Stage 2. No events of suicidal behavior were observed with either placebo or pimavanserin.
LIMITATIONS


The post hoc nature, exclusion of patients with any history of suicide from the primary study, and the small number of patients who demonstrated evidence of suicidal ideation.
CONCLUSIONS


Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD. Further study is needed to verify these results.",2020,"During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431).","['patients with major depressive disorder (MDD', 'patients with MDD', 'adults with MDD', 'patients with major depression', 'patients with MDD and an inadequate response to a']","['adjunctive pimavanserin', 'placebo', 'selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI']","['LS mean change for HAMD Item 3', 'incidence of suicidal ideation or behavior', 'suicidal ideation on the C-SSRS', 'Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events', 'suicidal ideation', 'suicidal behavior']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",,0.255115,"During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431).","[{'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: rcshelton@uabmc.edu.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.051']
2103,32871917,Comparison adductor canal block combined with local infiltration analgesia and adductor canal block alone for pain management after total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


Pain control after total knee arthroplasty has shown many advances; however, the optimal method remains controversial. The purpose of this present study is to assess the efficacy and safety of the addition of local infiltration analgesia to adductor canal block for pain control after primary total knee arthroplasty.
METHODS


This prospective randomized controlled research was conducted from January 2018 to June 2019. All the patients and their family members signed the informed consent forms, and this work was authorized via the ethics committee of Jinxiang Hospital Affiliated to Jining Medical College (JXHP0024578). Inclusion criteria were 55 years old or older, who possess the physical status I-III of American Society of Anesthesiologists, and the body mass index in the range of 18 to 30 kg/m. Exclusion criteria were regional and/or neuroaxial anesthesia contraindications, the history of drug allergy involved in the research, neuropathic pain, as well as the chronic pain requiring opioid therapy. Seventy-two patients were divided into 2 groups randomly. Study group (n = 36) received both adductor canal block and local infiltration analgesia. Control group (n = 36) received adductor canal block alone. Primary outcome included postoperative pain score (visual analog scale 0 to 10 cm, in which 0 represents no pain and 10 represents the most severe imaginable pain). The measures of secondary outcome included the knee range of motion, opioid consumption, the hospital stay length as well as the postoperative complications (for instance, pulmonary embolism, deep vein thrombosis, and the wound infection). All the analyses were conducted through utilizing the SPSS for Windows Version 20.0.
RESULTS


The results will be shown in .(Table is included in full-text article.) CONCLUSION:: The study will provide more evidence on the combination use of adductor canal block and local infiltration analgesia in the treatment of pain after the total knee arthroplasty.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5832).",2020,Control group (n = 36) received adductor canal block alone.,"['pain control after primary total knee arthroplasty', 'pain after the total knee arthroplasty', 'January 2018 to June 2019', 'Inclusion criteria were 55 years old or older, who possess the physical status I-III of American Society of Anesthesiologists, and the body mass index in the range of 18 to 30\u200akg/m', 'Seventy-two patients', 'pain management after total knee arthroplasty']","['local infiltration analgesia to adductor canal block', 'adductor canal block alone', 'adductor canal block and local infiltration analgesia', 'Comparison adductor canal block combined with local infiltration analgesia and adductor canal block alone']","['knee range of motion, opioid consumption, the hospital stay length as well as the postoperative complications (for instance, pulmonary embolism, deep vein thrombosis, and the wound infection', 'efficacy and safety', 'postoperative pain score (visual analog scale 0 to 10\u200acm, in which 0 represents no pain and 10 represents the most severe imaginable pain']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",72.0,0.0783024,Control group (n = 36) received adductor canal block alone.,"[{'ForeName': 'Qingchun', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Jinxiang Hospital Affiliated to Jining Medical College, Shandong, China.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021881']
2104,32871950,Evaluation of the efficacy of Conbercept in the treatment of diabetic macular edema based on OCTA.,"BACKGROUND


Diabetic macular edema (DME) can cause severe vision impairments for patients with diabetes. Recently, Conbercept has shown efficacy on DME with 3-monthly loading dose injection and pro re nata (PRN, 3+PRN) thereafter in retrospectivetrials. Furthermore, there are some other approaches have been recommended such as 2mg bimonthly (2q8) after 5 initial doses, or Conbercept 0.5mg treat-and-extend, however, some patients still have recurrence of the disease after treatment. Therefore, in order to identify more efficacy and safety approach on Conbercept inpatients with DME, a randomized controlled trial will be performed with 6-monthly loading dose injection and PRN (6+PRN) compared with 3+PRN treatments.
METHODS


This study is a multicenter, randomized control trial of Conbecept treating DME in China. Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited. All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment.
RESULTS


This study will provide a new powerful evidence of the efficacy and safety of Conbecept treating DME.
DISCUSSION


This RTC study will determine whether multiple treatments of Conbercept provide better effectiveness in patients with DME.
TRIAL REGISTRATION NUMBER


ChiCTR2000032728.",2020,"All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment.
","['patients with DME', 'diabetic macular edema based on OCTA', 'Conbercept inpatients with DME', 'Diabetic macular edema (DME', 'patients with diabetes', 'China', 'Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited']","['Conbecept treating DME', 'Conbercept', 'study agent treatment group (6+PRN) or a control group (3+PRN', 'PRN (6+PRN']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1833296', 'cui_str': 'CHMP2B-related frontotemporal dementia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0926971,"All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment.
","[{'ForeName': 'Teer', 'Initials': 'T', 'LastName': 'Ba', 'Affiliation': 'School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Shixuan', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Qiqige', 'Initials': 'Q', 'LastName': 'Caihan', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Bai', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Lao', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Guisen', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}]",Medicine,['10.1097/MD.0000000000021992']
2105,32871985,Multi-center study for acupuncture combined with Chinese medicine in the treatment of chronic spontaneous urticaria based on the theory of taking shu-stream points when the disease is aggravated.,"Chronic spontaneous urticaria (CSU) is a common dermatologic disease that seriously affects patient quality of life. The choice of therapy to control the disease and prevent its recurrence has always presented a difficult clinical issue. Previous studies have shown that traditional Chinese medicine is a safe and effective treatment for CSU. Recently, the temporal rhythms of CSU, a disease characterized by intermittent flares of active disease and periods of little or no disease, have attracted the attention of traditional Chinese medicine researchers. We designed a multicenter, randomized, controlled study to evaluate the efficacy and safety of combining a Chinese herbal formulation with acupuncture using shu-stream acupoints applied on the corresponding time meridians during disease exacerbations. We plan to recruit 111 outpatients with CSU aged 18 to 65 years. Participants will be randomized to 1 of the 3 groups: group A, which will be given basic acupuncture and the herbal formulation dangui yinzi; group B, which will be given danggui yinzi and shu-stream acupuncture; and a control group, which will be given danggui yinzi alone. Patients will be treated for 4 weeks and followed for 8 additional weeks. Investigators will evaluate the following parameters: the symptoms and side effects of treatment, quality of life (using the chronic urticaria quality of life questionnaire), and overall patient condition. Each week, patients will also complete the measurement of 7-day urticarial activity score. This is the first use of a combination of shu-stream acupoints and Chinese herbal medicine in the treatment of CSU. If successful, it will prove to be a simple, inexpensive, treatment strategy for solving a difficult clinical problem.",2020,This is the first use of a combination of shu-stream acupoints and Chinese herbal medicine in the treatment of CSU.,"['111 outpatients with CSU aged 18 to 65 years', 'Chronic spontaneous urticaria (CSU']","['shu-stream acupoints and Chinese herbal medicine', 'acupuncture combined with Chinese medicine', 'acupuncture', 'acupuncture and the herbal formulation dangui yinzi; group B, which will be given danggui yinzi and shu-stream acupuncture']","['quality of life (using the chronic urticaria quality of life questionnaire', 'efficacy and safety', '7-day urticarial activity score']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",111.0,0.0750674,This is the first use of a combination of shu-stream acupoints and Chinese herbal medicine in the treatment of CSU.,"[{'ForeName': 'Yuesi', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': ""aHospital of Chengdu University of Traditional Chinese Medicine bChengdu Integrated TCM & Western Medicine Hospital cThe First People's Hospital of Longquanyi District Chengdu dXinjin County Hospital of traditional Chinese Medicine, Chengdu, Sichuan, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Mingling', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021266']
2106,32872022,A multicenter randomized controlled trial to assess the efficacy of cancer green therapy in treatment of stage IIIb/IV non-small cell lung cancer.,"BACKGROUND


Chemotherapy is the main therapy for stage IIIB/IV non-small cell lung cancer (NSCLC). However, the 5-year survival rate is 6%. Cancer Green Therapy is a novel therapy in China, which refers to cryoablation combined with traditional Chinese medicine (TCM) formula. Our previous retrospective analysis showed that patients with NSCLC had longer survival time and better quality of life after receiving cryoablation combined with TCM formula, compared with patients who received chemotherapy alone.
METHODS


This study is a multicenter, randomized, controlled clinical study. The experiment will be carried out in 6 hospitals at the same time, and a total of 450 cases of participants will be randomly assigned to the experimental group and the control group (n = 225). The experimental group will be given cryoablation and 28-days TCM formula, and the control group will be given 4 cycles chemotherapy. After 30 months of follow-up, the efficacy and safety of cryoablation combines with TCM formula in patients with stage IIIB/IV NSCLC will be observed. The primary outcome is overall survival. The secondary outcomes include progression-free survival, objective response rate, and quality of life. We will also conduct a safety evaluation of the treatment at the end of the trial.
DISCUSSION


This multicenter, randomized, controlled clinical study not only provides data on the efficacy and safety of cryoablation combined with TCM formula, but also provides a novel treatment strategy for clinicians and advanced NSCLC patients.",2020,"Our previous retrospective analysis showed that patients with NSCLC had longer survival time and better quality of life after receiving cryoablation combined with TCM formula, compared with patients who received chemotherapy alone.
","['patients with stage IIIB/IV NSCLC', '6 hospitals at the same time, and a total of 450 cases of participants', 'clinicians and advanced NSCLC patients', 'stage IIIb/IV non-small cell lung cancer']","['cancer green therapy', 'Cancer Green Therapy', 'cryoablation combines with TCM formula', 'cryoablation combined with TCM formula', 'cryoablation and 28-days TCM formula']","['efficacy and safety', 'longer survival time and better quality of life', 'progression-free survival, objective response rate, and quality of life', '5-year survival rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010408', 'cui_str': 'Cryosurgery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",450.0,0.266615,"Our previous retrospective analysis showed that patients with NSCLC had longer survival time and better quality of life after receiving cryoablation combined with TCM formula, compared with patients who received chemotherapy alone.
","[{'ForeName': 'Manqiang', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Dongfang hospital Beijing University of Chinese Medicine, No.6 Community 1 Fangxingyuan, Fengtai District, Beijing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Xueni', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Haoyue', 'Initials': 'H', 'LastName': 'Pang', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Kaiwen', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021626']
2107,32897487,Reply to the letter of Soliman et al. regarding 'Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'.,,2020,,[],['balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'],[],[],"[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.0416543,,"[{'ForeName': 'N H M', 'Initials': 'NHM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. mvoskuil@umcutrecht.nl.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01488-w']
2108,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
2109,32898792,Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial.,"PURPOSE


Maintenance chemotherapy is a reasonable choice for patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.
PATIENTS AND METHODS


We conducted a randomised trial in patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m 2  d1, 22) in patients with non-squamous cell carcinoma or gemcitabine (1,150 mg/m 2  d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).
RESULTS


632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0-17.0) in the observation arm and 14 months (95% CI: 10.9-16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
CONCLUSION


Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC.",2020,"The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
","['elderly patients with advanced non-small cell lung cancer', 'elderly patients', 'patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45', 'patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500\xa0mg/m 2  d1, 22) in patients with non-squamous cell carcinoma or', 'elderly patients with advanced NSCLC', '632 patients were enrolled from May 2013 to October 2016', 'patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet', 'Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received']","['pemetrexed and 43 gemcitabine', 'Maintenance chemotherapy', 'gemcitabine', 'carboplatin and weekly paclitaxel doublet chemotherapy']","['median progression-free survival (PFS', 'median OS', 'overall survival (OS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",632.0,0.168415,"The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Quoix', 'Affiliation': 'Department of Pneumology, University Hospital of Strasbourg, Strasbourg, France. Electronic address: equoix@gmail.com.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Department of Pneumology, Toulon Sainte-Musse Hospital, Toulon, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Lavolé', 'Affiliation': 'Department of Pneumology, Tenon Hospital, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Department of Pneumology, Hospital of Le Mans, Le Mans, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Westeel', 'Affiliation': 'Department of Pneumology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Le Treut', 'Affiliation': ""Department of Pneumology, Pays D'Aix Hospital, Aix-en-Provence, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pichon', 'Affiliation': 'Department of Pneumology, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'Department of Medical Oncology, Hospital Layné, Mont-de-Marsan, France.'}, {'ForeName': 'Josiane', 'Initials': 'J', 'LastName': 'Otto', 'Affiliation': ""University of Côte D'Azur, Nice, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Moreau', 'Affiliation': 'Department of Pneumology, Louis Pasteur Hospital, Colmar, France.'}, {'ForeName': 'Jeannick', 'Initials': 'J', 'LastName': 'Madelaine', 'Affiliation': 'Department of Pneumology, University Hospital of Caen Normandie, Caen, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dumont', 'Affiliation': 'Department of Pneumology, Hospital of Chauny, Chauny, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': ""Department of Pneumology, Hôpital D'Instruction des Armées Percy, Clamart, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Debieuvre', 'Affiliation': 'Department of Pneumology, GHRMSA, Emile Miller Hospital, Mulhouse, France.'}, {'ForeName': 'Patrick Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Department of Pneumology, Hospital of Pau, Pau, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pujol', 'Affiliation': 'Department of Thoracic Oncology, Montpellier Regional University Hospital, Montpellier, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlais', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Thoracic Oncology Unit, Grenoble-Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Department of Pneumology and Thoracic Oncology, Hospital of Lyon Sud, Lyon, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.034']
2110,32900246,A randomized placebo-controlled study investigating the efficacy of inspiratory muscle training in the treatment of children with bronchial asthma.,"OBJECTIVE


To investigate the efficacy of inspiratory muscle training (IMT) on respiratory functions, respiratory muscle strength, and asthma symptoms in asthmatic children.
METHODS


In a randomized placebo-controlled assessor-blinded study, 34 children with asthma were randomized to receive either the IMT at 40% of the maximal inspiratory pressure (IP max ) for 20 min/session, thrice/week, over 12 consecutive weeks (IMT group;  n  = 17) or placebo IMT at 5% of IP max  (placebo group;  n  = 17). Additionally, both groups received the conventional respiratory rehabilitation (CRR) program. Outcome measurements performed pre- and post-treatment, included respiratory functions [forced expiratory volume at the first second (FEV 1 ), forced vital capacity (FEV), and FEV 1 /FVC], respiratory muscle strength [represented by IP max  and maximal expiratory pressure (EP max ), and asthma control test (ACT).
RESULTS


At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC ( P =.004), IP max  ( P =.002), EP max  ( P =.004), and ACT ( P =.001) adjusted to the pretreatment values, in favor of the IMT group.
CONCLUSION


Incorporation of IMT in the CRR program for children with asthma can improve respiratory function, enhance respiratory muscle strength, and improve children's perception of asthma symptoms.",2020,"At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC","['34 children with asthma', 'children with asthma', 'children with bronchial asthma', 'asthmatic children']","['IMT', 'inspiratory muscle training (IMT', 'conventional respiratory rehabilitation (CRR) program', 'placebo', 'inspiratory muscle training', 'maximal inspiratory pressure (IP max ', 'placebo IMT at 5% of IP max  (placebo']","['FEV 1 /FVC', 'EP max', ""children's perception of asthma symptoms"", 'pre- and post-treatment, included respiratory functions [forced expiratory volume at the first second (FEV 1 ), forced vital capacity (FEV), and FEV 1 /FVC], respiratory muscle strength [represented by IP max  and maximal expiratory pressure (EP max ), and asthma control test (ACT', 'respiratory functions, respiratory muscle strength, and asthma symptoms', 'FVC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",34.0,0.139749,"At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1821058']
2111,32871505,Social support modifies the association between hazardous drinking and depression symptoms among ART clients in Vietnam.,"INTRODUCTION


Hazardous drinking is widespread among people with HIV (PWH). PWH are also vulnerable to depression due to HIV-related social stigma, and social support can play an important role in improving mental health for this population. No studies have explored whether social support modifies the association of hazardous drinking and depressive symptoms among PWH.
METHODS


We used baseline data from a randomized controlled trial of two evidence-based alcohol reduction interventions among antiretroviral therapy clients in Vietnam. Hazardous alcohol use was defined as having a score ≥8 for men and ≥ 7 for women on the Alcohol Use Disorders Identification Test. The presence of depression symptoms was defined as a score ≥ 5 on the Patient Health Questionnaire-9. Social support was measured with a 5-question modified version of the Medical Outcomes Study Social Support Instrument. Crude (CPRs) and adjusted prevalence ratios (aPRs) of the association were presented.
RESULTS


Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52). Hazardous drinking and depression symptoms were not associated among those with high social support (aPR = 1.01;95%CI 0.76-1.35), but were associated among those with medium (aPR = 1.24;95%CI 0.92-1.69) and low social support (aPR = 1.71;95%CI 1.25-2.34).
CONCLUSIONS


Social support significantly modified the association between hazardous drinking and depression symptoms among ART clients in Vietnam. Interventions to decrease hazardous alcohol use are broadly indicated for PWH in Vietnam and other low-resource settings, but special attention or modifications may be needed to support mental health among those with lower levels of social support.",2020,"RESULTS


Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52).","['ART clients in Vietnam', 'people with HIV (PWH', 'antiretroviral therapy clients in Vietnam']",['evidence-based alcohol reduction interventions'],"['Hazardous drinking and depression symptoms', 'depression symptoms', 'hazardous drinking and depression symptoms', 'Crude (CPRs) and adjusted prevalence ratios (aPRs', 'likelihood of having depressive symptoms']","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",,0.0256045,"RESULTS


Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52).","[{'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Epidemiology, Institute of Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam. Electronic address: binhminh@live.unc.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Department of Epidemiology, College of Public Health, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Q X', 'Initials': 'QX', 'LastName': 'Bui', 'Affiliation': 'UNC Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Tran', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; UNC Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108249']
2112,32871529,"Changes in glenohumeral translation, electromyographic activity, and pressure-pain thresholds following sustained or oscillatory mobilizations in stiff and healthy shoulders: Results of a randomized, controlled laboratory trial.","STUDY DESIGN


Randomized Controlled Laboratory Study.
BACKGROUND


Posterior glide glenohumeral (GH) mobilizations are utilized to improve motion and decrease pain in patients with shoulder pathologies, thought to be due to capsular stretch and neurophysiologic effects. However, it remains unclear how different GH mobilizations influence mobility, rotator cuff (RC) activity, and pain processing, or if effects are different in stiff (≥15-degree loss of passive motion in any plane) rather than healthy shoulders.
OBJECTIVES


To compare the effects of oscillatory and sustained posterior GH mobilizations on translation, RC activity, and pressure pain threshold (PPT) in stiff and healthy shoulders.
METHODS


Eighty-eight participants, (44 control, 44 stiff shoulders) were randomly assigned to one of two mobilization conditions. Pre-post intervention measurements of PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography were performed. Sustained or oscillatory grade III posterior GH mobilizations were then provided to all participants. Data were analyzed using tests of difference and regression modeling.
RESULTS


Sustained glides (2.8 ± 3.3 mm) demonstrated significantly greater changes in translation compared to oscillatory glides (1.1 ± 3.9 mm), p = .028. Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01). Small changes in PPT occurred across all conditions, none reaching clinically meaningful levels.
CONCLUSION


Sustained mobilizations resulted in greater changes in GH translation. RC activity was higher in the stiff shoulder group, and remained higher post-intervention despite gains in GH translation, suggesting a mechanical rather than neurophysiologic effect. There was no meaningful difference in PPT between modes of mobilization.
LEVEL OF EVIDENCE


Therapy, Randomized Controlled Laboratory Study, Level 1b.",2020,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","['stiff and healthy shoulders', 'patients with shoulder pathologies', 'Eighty-eight participants, (44 control, 44 stiff shoulders']","['Posterior glide glenohumeral (GH) mobilizations', 'sustained or oscillatory mobilizations', 'oscillatory and sustained posterior GH mobilizations']","['glenohumeral translation, electromyographic activity, and pressure-pain thresholds', 'GH translation', 'RC activity', 'PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography', 'PPT', 'total RC activity', 'mobility, rotator cuff (RC) activity, and pain processing', 'translation, RC activity, and pressure pain threshold (PPT']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",88.0,0.18114,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Swanson', 'Affiliation': 'University of Hartford, West Hartford, CT, USA; University of New England, Portland, ME, USA. Electronic address: bswanson@Hartford.edu.'}, {'ForeName': 'J Adrienne', 'Initials': 'JA', 'LastName': 'McAuley', 'Affiliation': 'University of New England, Portland, ME, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': 'University of New England, Portland, ME, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102243']
2113,32871620,Radiologic comparative analysis between saline and platelet-rich fibrin filling after hydraulic transcrestal sinus lifting without adjunctive bone graft: A randomized controlled trial.,"OBJECTIVES


To evaluate implant survival rate, any complications, and changes in residual alveolar bone height (RABH) using saline or platelet-rich fibrin (PRF) filling after hydraulic transcrestal sinus lifting.
METHODS


Dental implants were placed after hydraulic transcrestal sinus lifting and the filling of saline (20 patients) or PRF (20 patients). Outcome measurements were implant survival, any complications, and RABH changes. Cone-beam computed tomography (CBCT) scans were taken and compared preoperatively (T0), immediately postoperatively (T1), at 3 months (T2), 6 months (T3), and 12 months postoperatively (T4), respectively.
RESULTS


In a total of 40 patients, 45 implants with a mean length of 10.4 ± 0.8 mm were placed in posterior maxilla of a mean RABH of 6.8 ± 1.1 mm. The increase in RABH peaked at T1, and continuous drooping of the sinus membrane was observed but stabilized at T3. Meanwhile, the gradual increase in the radiopacities was found below the lifted sinus membrane. The PRF filling induced the radiographic intrasinus bone gain of 2.6 ± 1.1 mm, which was significantly more than 1.7 ± 1.0 mm of saline filling at T4 (p < .05). All the implants were in function with no significant complications over the one-year follow-up period.
CONCLUSIONS


In this randomized case-control study, the feasibility of hydraulic transcrestal sinus lifting without bone graft was confirmed and PRF might be a better filler to support the elevated sinus membrane. However, adjunctive bone grafting should still be indicated for cases requiring more than 2-3 mm of intrasinus bone gain.",2020,"All the implants were in function with no significant complications over the one-year follow-up period.
","['40 patients, 45 implants with a mean length of 10.4 ± 0.8 mm were placed in posterior maxilla of a mean RABH of 6.8 ± 1.1 mm', 'after hydraulic transcrestal sinus lifting without adjunctive bone graft', 'Dental implants were placed after hydraulic transcrestal sinus lifting and the filling of saline (20 patients) or PRF (20 patients']","['saline or platelet-rich fibrin (PRF', 'saline and platelet-rich fibrin filling', 'hydraulic transcrestal sinus lifting without bone graft', 'Cone-beam computed tomography (CBCT) scans']","['implant survival, any complications, and RABH changes', 'implant survival rate, any complications, and changes of residual alveolar bone height (RABH', 'RABH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",40.0,0.108039,"All the implants were in function with no significant complications over the one-year follow-up period.
","[{'ForeName': 'Yong-Seok', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Private Practice, Oral and Maxillofacial Surgery, Apsun Dental Hospital, Seoul, Korea.'}, {'ForeName': 'Kyung-Gyun', 'Initials': 'KG', 'LastName': 'Hwang', 'Affiliation': 'Division of Oral and Maxillofacial Surgery, Department of Dentistry, College of Medicine, Hanyang University, Seoul, Korea.'}, {'ForeName': 'Sang Ho', 'Initials': 'SH', 'LastName': 'Jun', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tallarico', 'Affiliation': 'Department of Periodontology and Implantology, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Kwon', 'Affiliation': 'Biostatistics Core, Medicine-Engineering-Bio (MEB) Global Development Research Center, Industry-University Cooperation Foundation, Hanyang University, Seoul, Korea.'}, {'ForeName': 'Chang-Joo', 'Initials': 'CJ', 'LastName': 'Park', 'Affiliation': 'Division of Oral and Maxillofacial Surgery, Department of Dentistry, College of Medicine, Hanyang University, Seoul, Korea.'}]",Clinical oral implants research,['10.1111/clr.13655']
2114,32871885,Effect of a critical thinking intervention on stress management among undergraduates of adult education and extramural studies programs.,"OBJECTIVE


The objective of this study was to examine the effect of a critical thinking intervention (CTI) on stress management among undergraduates of adult education and extramural studies programs.
METHOD


A total of 44 undergraduates were randomly sorted into experimental and waitlist control groups. We used the Perceived Stress Scale for data collection at the pre-test, post-test, and follow-up stages. We used unpaired t and paired t-tests to analyze the data collected. SPSS version 22.0 was used for the data analyses (SPSS Inc., Chicago, IL).
RESULTS


It was shown that the CTI was effective in reducing the mean stress of the participants compared to the control group both in the post-test (t[42] = -22.453, P < .001) and follow-up periods (t[42] = -34.292, P < .001). There were statistically significant changes in the mean stress of participants in the experimental group from the pre-test to post-test phases (t[23] = 26.30, P = .000, r = .08], and from pre-test to follow-up(t[23] = 37.10, P = .000, r = .30). The mean stress of the participants in the experimental group from post-test to follow-up signified the sustained positive influence of the CTI on the mean stress (t[23] = 2.41, P = .000, r = .46) of the undergraduates.
CONCLUSION


This study adds to the literature by showing that a CTI is a valuable strategy for stress reduction in a university environment. Given that the CTI demonstrated the ability to reduce stress among undergraduates enrolled in adult education and extramural studies programs, we hope that similar interventions will be adopted to manage and prevent stress among students in other departments and disciplines.",2020,"It was shown that the CTI was effective in reducing the mean stress of the participants compared to the control group both in the post-test (t[42] = -22.453, P < .001) and follow-up periods (t[42] = -34.292, P < .001).","['undergraduates of adult education and extramural studies programs', 'A total of 44 undergraduates']","['critical thinking intervention (CTI', 'critical thinking intervention']",['mean stress'],"[{'cui': 'C0424936', 'cui_str': 'Adult education'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",44.0,0.0230015,"It was shown that the CTI was effective in reducing the mean stress of the participants compared to the control group both in the post-test (t[42] = -22.453, P < .001) and follow-up periods (t[42] = -34.292, P < .001).","[{'ForeName': 'Charity Chinelo', 'Initials': 'CC', 'LastName': 'Okide', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Ifeyinwa O', 'Initials': 'IO', 'LastName': 'Ezenwaji', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Moses O', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Rosemary Ogochukwu', 'Initials': 'RO', 'LastName': 'Igbo', 'Affiliation': 'Faculty of Education, Alex Ekwueme Federal University Ndufu-Alike Ikwo.'}, {'ForeName': 'Uzoamaka Lucynda', 'Initials': 'UL', 'LastName': 'Koledoye', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Nwakaego Ebele', 'Initials': 'NE', 'LastName': 'Ekwealor', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Osilike', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Nkechi Mercy', 'Initials': 'NM', 'LastName': 'Okeke', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Ngozi Justina', 'Initials': 'NJ', 'LastName': 'Igwe', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Ruphina U', 'Initials': 'RU', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Lambert Peter', 'Initials': 'LP', 'LastName': 'Ukanga', 'Affiliation': 'Department of Philosophy, University of Nigeria, Nsukka, P.M.B., Enugu State.'}, {'ForeName': 'Mulii Falaremi', 'Initials': 'MF', 'LastName': 'Olajide', 'Affiliation': 'Department of Adult Education and Community Development, Ibrahim Badamasi Babangida University, Lapai, Niger State.'}, {'ForeName': 'Anthonia Ekanibe', 'Initials': 'AE', 'LastName': 'Onuorah', 'Affiliation': 'Department of Guidance & Counselling, Enugu State University of Science and Technology, Enugu State, Nigeria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ujah', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Lambert K', 'Initials': 'LK', 'LastName': 'Ejionueme', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Godwin C', 'Initials': 'GC', 'LastName': 'Abiogu', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}]",Medicine,['10.1097/MD.0000000000021697']
2115,32871891,Efficacy of oral Vitamin D supplementation in reducing body mass index and lipid profile in adolescents and young adults in Colombia: A pilot clinical trial protocol nested in the SIMBA cohort.,"BACKGROUND


In recent years, the role of vitamin D (VD) as a protective factor in cardiovascular disease has been recognized. Thus, there is a need to study the effect of vitamin D supplementation in the control of different cardiovascular risk factors and metabolic syndrome, especially in young populations where few studies have been conducted.
METHODS


Pilot study of a randomized, parallel two-arm, triple-blind clinical controlled trial in 150 adolescents and young adults in the city of Bucaramanga-Colombia. The intervention group will receive 1000 IU of VD and the control group 200 IU of VD daily for 15 weeks. The main outcomes are: serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio). Other variables will be analyzed such as assessment of dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and compliance with VD supplementation.
DISCUSSION


This study is innovative since there is little evidence from clinical trials in adolescents and young adults; similar studies are not known in our context. The results of this study may facilitate the recommendation of oral vitamin D supplementation in the population of interest. In addition, it is a low-cost and easy-to-apply intervention that could contribute to the formulation and implementation of health policies.
TRIAL REGISTRATION


NCT04377386.",2020,"The main outcomes are: serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio).","['adolescents and young adults', '150 adolescents and young adults in the city of Bucaramanga-Colombia', 'adolescents and young adults in Colombia']","['vitamin D supplementation', 'oral Vitamin D supplementation', 'oral vitamin D supplementation', 'vitamin D (VD']","['dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and compliance with VD supplementation', 'body mass index and lipid profile', 'serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}]",150.0,0.109072,"The main outcomes are: serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio).","[{'ForeName': 'Norma C', 'Initials': 'NC', 'LastName': 'Serrano', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Romero', 'Affiliation': 'Universidad Industrial de Santander, Bucaramanga.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Suárez', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Lyda Z', 'Initials': 'LZ', 'LastName': 'Rojas', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Edna Magaly', 'Initials': 'EM', 'LastName': 'Gamboa-Delgado', 'Affiliation': 'Universidad Industrial de Santander, Bucaramanga.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Forero', 'Affiliation': 'Hospital Internacional de Colombia, Piedecuesta, Colombia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Guio', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Doris Cristina', 'Initials': 'DC', 'LastName': 'Quintero-Lesmes', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}]",Medicine,['10.1097/MD.0000000000021722']
2116,32871910,A randomized controlled trial study protocol of modified Mahuang-Fuzi-Xixin decoction in the treatment of patients with mild bronchial asthma during acute exacerbation.,"INTRODUCTION


These years, due to dissatisfaction with western medicine treatments, traditional Chinese medicine (TCM) becomes a main treatment for bronchial asthma patients. Lung and kidney yang deficiency syndrome is a common type of asthma and the Chinese herbal medicine formula modified Mahuang-Fuzi-Xixin (MFX) decoction is prescribed for mild bronchial asthma patients with acute exacerbation syndrome. However, there is not obvious evidence to support the efficacy and safety of modified MFX decoction the efficacy and safety to treat mild bronchial asthma and the mechanism of this disease is still unclear.
METHODS


A double-blind, placebo-controlled, randomized clinical trial was proposed by us. After a 10-day run-in period, 180 eligible objects will be recruited in this study. These subjects will be allocated to the experimental group or control group in a 1:1 ratio. Patients in the experimental group will take modified MFX decoction. At the same time, patients in the control group will receive a matched placebo. The budesonide inhalation powder will be used as a western medicine treatment for both groups. All subjects will receive 14 days of treatment and another 6 months of follow-up. The primary outcome is the mean change in peak expiratory flow rate from the baseline to 14 days in this research. The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage. This trial will also explore the association between the change of immunoglobulin E and modified MFX decoction treatment. Any side effects of the treatment will be recorded.
DISCUSSION


The results of this trial will provide the evidence for the effect of modified MFX decoction in patients with mild bronchial asthma during acute exacerbation. It also will explore the mechanism of this formula in the treatment of bronchial asthma, which will provide another treatment option for patients with mild bronchial asthma.",2020,"The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage.","['bronchial asthma patients', 'patients with mild bronchial asthma', 'mild bronchial asthma patients with acute exacerbation syndrome', 'patients with mild bronchial asthma during acute exacerbation']","['traditional Chinese medicine (TCM', 'Fuzi-Xixin (MFX) decoction', 'modified Mahuang-Fuzi-Xixin decoction', 'immunoglobulin E and modified MFX decoction treatment', 'placebo', 'modified MFX decoction']","['forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage', 'mean change in peak expiratory flow rate']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C3501467', 'cui_str': 'fuzi'}, {'cui': 'C4309118', 'cui_str': 'mahuang fuzi xixin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}]",180.0,0.114145,"The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage.","[{'ForeName': 'Wenfan', 'Initials': 'W', 'LastName': 'Gan', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Maojuan', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jundong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Hui', 'Affiliation': 'Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Keni', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Niao', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liao', 'Affiliation': 'Department of Endocrinology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",Medicine,['10.1097/MD.0000000000021858']
2117,32871913,"Preoperative evaluation using external lumbar drainage for patients with posthemorrhagic hydrocephalus: A prospective, monocentric, randomized controlled trial.","BACKGROUND


External lumbar drainage (ELD) remains the most common used methods with a higher sensitivity before lumboperitoneal shunt (LPS) implantation to predict the shunt outcomes in the treatment of idiopathic normal pressure hydrocephalus. However, the benefits of such supplemental test have not been tested in the treatment of post-hemorrhagic hydrocephalus (PHH).
METHODS AND DESIGN


In the current trial, 100 eligible patients with PHH will be recruited and randomly assigned to the ELD group (study group) and non-ELD group (control group). Lumbar puncture (LP) will be performed for participants in non-ELD group. LP plus ELD will be performed for participants in ELD group, those who will then be investigated the suitability of potential LPS 4 days after ELD. Two independent and practiced assessors will collect the baseline data and evaluate each participant 4 days after ELD or LP, 1 day after LPS, at the time of discharge and 1 month after LPS. The primary outcome is the shunting outcomes 1 month after surgery. The secondary outcomes include the complications related to ELD, complications related to LPS, and Evens index at each evaluation point. Meanwhile, serious adverse events occurring at any time is recorded to determine the safety of this trial.
DISCUSSION


The results of this trial will demonstrate whether preoperative evaluation using temporary ELD for patients with PHH could attenuate the risk of LPS failure.
TRIAL REGISTRATION NUMBER


ChiCTR2000034094; Pre-results.",2020,"The secondary outcomes include the complications related to ELD, complications related to LPS, and Evens index at each evaluation point.","['idiopathic normal pressure hydrocephalus', 'patients with posthemorrhagic hydrocephalus', 'participants in non-ELD group', '100 eligible patients with PHH']","['External lumbar drainage (ELD', 'LP plus ELD', 'ELD', 'lumboperitoneal shunt (LPS) implantation', 'Lumbar puncture (LP', 'external lumbar drainage']","['complications related to ELD, complications related to LPS, and Evens index at each evaluation point', 'shunting outcomes 1 month after surgery']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0020258', 'cui_str': 'Normal pressure hydrocephalus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299564', 'cui_str': 'Posthemorrhagic hydrocephalus'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephalus'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",100.0,0.220634,"The secondary outcomes include the complications related to ELD, complications related to LPS, and Evens index at each evaluation point.","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Jingguo', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Yikai', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'You', 'Affiliation': 'Department of Neurosurgery.'}]",Medicine,['10.1097/MD.0000000000021872']
2118,32871100,"Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


Cardiac muscle hypercontractility is a key pathophysiological abnormality in hypertrophic cardiomyopathy, and a major determinant of dynamic left ventricular outflow tract (LVOT) obstruction. Available pharmacological options for hypertrophic cardiomyopathy are inadequate or poorly tolerated and are not disease-specific. We aimed to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive hypertrophic cardiomyopathy.
METHODS


In this phase 3, randomised, double-blind, placebo-controlled trial (EXPLORER-HCM) in 68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms were assigned (1:1) to receive mavacamten (starting at 5 mg) or placebo for 30 weeks. Visits for assessment of patient status occurred every 2-4 weeks. Serial evaluations included echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration. The primary endpoint was a 1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2 ) and at least one NYHA class reduction or a 3·0 mL/kg per min or greater pVO 2  increase without NYHA class worsening. Secondary endpoints assessed changes in post-exercise LVOT gradient, pVO 2 , NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB). This study is registered with ClinicalTrials.gov, NCT03470545.
FINDINGS


Between May 30, 2018, and July 12, 2019, 429 adults were assessed for eligibility, of whom 251 (59%) were enrolled and randomly assigned to mavacamten (n=123 [49%]) or placebo (n=128 [51%]). 45 (37%) of 123 patients on mavacamten versus 22 (17%) of 128 on placebo met the primary endpoint (difference +19·4%, 95% CI 8·7 to 30·1; p=0·0005). Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1; p<0·0001), greater increase in pVO 2  (+1·4 mL/kg per min, 0·6 to 2·1; p=0·0006), and improved symptom scores (KCCQ-CSS +9·1, 5·5 to 12·7; HCMSQ-SoB -1·8, -2·4 to -1·2; p<0·0001). 34% more patients in the mavacamten group improved by at least one NYHA class (80 of 123 patients in the mavacamten group vs 40 of 128 patients in the placebo group; 95% CI 22·2 to 45·4; p<0·0001). Safety and tolerability were similar to placebo. Treatment-emergent adverse events were generally mild. One patient died by sudden death in the placebo group.
INTERPRETATION


Treatment with mavacamten improved exercise capacity, LVOT obstruction, NYHA functional class, and health status in patients with obstructive hypertrophic cardiomyopathy. The results of this pivotal trial highlight the benefits of disease-specific treatment for this condition.
FUNDING


MyoKardia.",2020,"Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1;","['68 clinical cardiovascular centres in 13 countries, patients with hypertrophic cardiomyopathy with an LVOT gradient of 50 mm Hg or greater and New York Heart Association (NYHA) class II-III symptoms', 'patients with obstructive hypertrophic cardiomyopathy', 'Between May 30, 2018, and July 12, 2019', '429 adults were assessed for eligibility, of whom 251 (59', 'symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM']","['placebo', 'placebo-controlled trial (EXPLORER-HCM', 'mavacamten', 'Mavacamten']","['Safety and tolerability', 'echocardiogram, electrocardiogram, and blood collection for laboratory tests and mavacamten plasma concentration', 'symptom scores', 'exercise capacity, LVOT obstruction, NYHA functional class, and health status', 'changes in post-exercise LVOT gradient, pVO 2 , NYHA class, Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), and Hypertrophic Cardiomyopathy Symptom Questionnaire Shortness-of-Breath subscore (HCMSQ-SoB', 'sudden death', '1·5 mL/kg per min or greater increase in peak oxygen consumption (pVO 2 ']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0450400', 'cui_str': '50mm'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551472', 'cui_str': 'Hypertrophic obstructive cardiomyopathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0262500', 'cui_str': 'Routine health maintenance'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0344917', 'cui_str': 'Left ventricular outflow tract obstruction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic cardiomyopathy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",429.0,0.654238,"Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (-36 mm Hg, 95% CI -43·2 to -28·1;","[{'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Olivotto', 'Affiliation': 'Cardiomyopathy Unit, Azienda Ospedaliera Universitaria Careggi, Florence, Italy; University of Florence, Florence, Italy. Electronic address: iacopo.olivotto@unifi.it.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Oreziak', 'Affiliation': '1st Department of Arrhythmia, National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barriales-Villa', 'Affiliation': 'Unidad de Cardiopatías Familiares, Instituto de Investigación Biomédica de A Coruña, A Coruña, Spain; Complexo Hospitalario Universitario de A Coruña, A Coruña, Spain; Servizo Galego de Saúde, A Coruña, Spain; Universidade da Coruña, A Coruña, Spain; Centro de Investigación Biomédica en Red, Madrid, Spain.'}, {'ForeName': 'Theodore P', 'Initials': 'TP', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Masri', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Garcia-Pavia', 'Affiliation': 'Centro de Investigación Biomédica en Red, Madrid, Spain; Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain; Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Saberi', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Neal K', 'Initials': 'NK', 'LastName': 'Lakdawala', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wheeler', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Owens', 'Affiliation': 'University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Kubanek', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wojakowski', 'Affiliation': 'Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Morten K', 'Initials': 'MK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gimeno-Blanes', 'Affiliation': 'Inherited Cardiac Disease Unit, University Hospital Virgen de la Arrixaca, Murcia, Spain.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Afshar', 'Affiliation': 'Intermountain Medical Center Heart Institute, Intermountain Medical Center, Murray, UT, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Division of Cardiology, Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, USA; Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Hegde', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Sehnert', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Mondira', 'Initials': 'M', 'LastName': 'Bhattacharya', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'MyoKardia, Brisbane, CA, USA.'}, {'ForeName': 'Cynthia Burstein', 'Initials': 'CB', 'LastName': 'Waldman', 'Affiliation': 'HCMBeat, Los Angeles, CA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Lester', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University, New Haven, CT, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31792-X']
2119,32871238,"""Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study"".","OBJECTIVE


The vitamin D endocrine system may have a variety of actions on cells and tissues involved in COVID-19 progression especially by decreasing the Acute Respiratory Distress Syndrome. Calcifediol can rapidly increase serum 25OHD concentration. We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
DESIGN


Parallel pilot randomized open label, double-masked clinical trial.
SETTING


University hospital setting (Reina Sofia University Hospital, Córdoba Spain.) PARTICIPANTS: 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1).
PROCEDURES


All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400 mg every 12 h on the first day, and 200 mg every 12 h for the following 5 days), azithromycin (500 mg orally for 5 days. Eligible patients were allocated at a 2 calcifediol:1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths.
RESULTS


Of 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50 %) p value X 2  Fischer test p < 0.001. Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95 %CI 0.002-0.17). Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95 %CI: 0.003-0.25). Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged.
CONCLUSION


Our pilot study demonstrated that administration of a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. Calcifediol seems to be able to reduce severity of the disease, but larger trials with groups properly matched will be required to show a definitive answer.",2020,"We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
","['50 patients treated with', 'patients requiring hospitalization due to proven COVID-19', 'Eligible patients', ' 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1', '13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged', 'All hospitalized patients', 'Spanish patients hospitalized for COVID-19', 'university hospital setting (Reina Sofia University Hospital, Córdoba Spain', 'Patients Hospitalized for COVID-19', '13 patients admitted to the ICU, two died and the remaining 11 were discharged']","['hydroxychloroquine', 'Calcifediol or 25-hydroxyvitamin D', 'azithromycin', 'oral calcifediol', 'Calcifediol', 'calcifediol']","['rate of ICU admission and deaths', 'serum 25OHD concentration', 'Intensive Care Unit Admission and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536597', 'cui_str': 'Patient requires hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0032310', 'cui_str': 'Viral pneumonia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0445270', 'cui_str': 'Sofia'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",13.0,0.0691693,"We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Entrenas Castillo', 'Affiliation': 'UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain.'}, {'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Entrenas Costa', 'Affiliation': 'UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain. Electronic address: lmentrenas@uco.es.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vaquero Barrios', 'Affiliation': 'UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Alcalá Díaz', 'Affiliation': 'Departamento de Medicina Interna. IMIBIC, CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López Miranda', 'Affiliation': 'Departamento de Medicina Interna. IMIBIC, CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bouillon', 'Affiliation': 'Department of Chronic Diseases, Metabolism and Ageing, Laboratory of Clinical and Experimental Endocrinology, KU Leuven, Herestraat, ON1/902, 3000, Leuven, Belgium.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Quesada Gomez', 'Affiliation': 'IMIBIC. CIBER de Fragilidad y Envejecimiento Saludable. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 18 14004, Córdoba, Spain.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105751']
2120,32881723,Contribution of Stimulus Variability to Word Recognition in Noise Versus Two-Talker Speech for School-Age Children and Adults.,"BACKGROUND


Speech-in-speech recognition scores tend to be more variable than the speech-in-noise recognition scores, both within and across listeners. This variability could be due to listener factors, such as individual differences in audibility or susceptibility to informational masking. It could also be due to stimulus variability, with some speech-in-speech samples posing more of a challenge than others. The purpose of this experiment was to test two hypotheses: (1) that stimulus variability affects adults' word recognition in a two-talker speech masker and (2) that stimulus variability plays a smaller role in children's performance due to relatively greater contributions of listener factors.
METHODS


Listeners were children (5 to 10 years) and adults (18 to 41 years) with normal hearing. Target speech was a corpus of 30 disyllabic words, each associated with an unambiguous illustration. Maskers were 30 samples of either two-talker speech or speech-shaped noise. The task was a four-alternative forced choice. Speech reception thresholds were measured adaptively, and those results were used to determine the signal-to-noise ratio associated with ≈65% correct for each listener and masker. Two 30-word blocks of fixed-level testing were then completed in each of the two conditions: (1) with the target-masker pairs randomly assigned prior to each block and (2) with frozen target-masker pairs.
RESULTS


Speech reception thresholds were lower for adults than for children, particularly for the two-talker speech masker. Listener responses in fixed-level testing were evaluated for consistency across listeners. Target sample was the best predictor of performance in the speech-shaped noise masker for both the random and frozen conditions. In contrast, both the target and masker samples affected performance in the two-talker masker. Results were qualitatively similar for children and adults, and the pattern of performance across stimulus samples was consistent, with differences in masked target audibility in both age groups.
CONCLUSIONS


Although word recognition in speech-shaped noise differed consistently across target words, recognition in a two-talker speech masker depended on both the target and masker samples. These stimulus effects are broadly consistent with a simple model of masked target audibility. Although variability in speech-in-speech recognition is often thought to reflect differences in informational masking, the present results suggest that variability in energetic masking across stimuli can play an important role in performance.",2020,Target sample was the best predictor of performance in the speech-shaped noise masker for both the random and frozen conditions.,"['Listeners were children (5 to 10 years) and adults (18 to 41 years) with normal hearing', 'School-Age Children and Adults']",[],['Listener responses'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],[],,0.038299,Target sample was the best predictor of performance in the speech-shaped noise masker for both the random and frozen conditions.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Buss', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Calandruccio', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Leibold', 'Affiliation': 'Center for Hearing Research, Boys Town National Research Hospital, Omaha, Nebraska, USA.'}]",Ear and hearing,['10.1097/AUD.0000000000000951']
2121,32881796,Effects of an intervention on internalized HIV-related stigma for individuals newly entering HIV care.,"OBJECTIVE


Considering the association between internalized HIV-related stigma and treatment adherence, an intervention addressing HIV treatment adherence may have the added benefit of reducing internalized stigma. The 'integrating ENGagement and Adherence Goals upon Entry' (iENGAGE) intervention was developed to facilitate adjustment to living with HIV among individuals newly engaged in HIV care. We evaluated the effects of this intervention on internalized stigma and examined whether the effect is moderated by depressive symptoms and coping styles.
DESIGN


The iENGAGE intervention was tailored individually to improve information, motivation, and behavioral skills to promote treatment adherence and viral suppression. Three hundred and seventy-one participants initiating HIV care at four sites in the United States were randomly assigned to either the intervention receiving four face-to-face sessions or standard of care control arm.
METHODS


Baseline and 48-week follow-up assessments were conducted, which included validated measures of internalized HIV-related stigma, depressive symptoms, and coping mechanisms (behavioral disengagement and self-blame) as secondary outcomes. A repeated measures ANOVA evaluated the effect of the intervention on change in internalized HIV stigma. Furthermore, the moderating effects of depressive symptoms and coping mechanisms on the decrease in internalized stigma were examined.
RESULTS


The decrease in internalized stigma from baseline to 48 weeks was significantly larger in the intervention arm compared with the control arm. This effect was significantly moderated by baseline levels of depressive symptoms and self-blame.
CONCLUSION


The multifaceted iENGAGE intervention is effective in reducing internalized stigma for new-to-HIV care individuals, especially with higher depressive symptoms or when using higher levels of self-blame coping.",2020,"The multifaceted iENGAGE intervention is effective in reducing internalized stigma for new-to-HIV care individuals, especially with higher depressive symptoms or when using higher levels of self-blame coping.","['individuals newly entering HIV care', 'Three hundred and seventy-one participants initiating HIV care at four sites in the United States']",['intervention receiving four face-to-face sessions or standard of care control arm'],"['internalized HIV-related stigma', 'internalized stigma', 'internalized HIV stigma', 'depressive symptoms and self-blame', 'internalized HIV-related stigma, depressive symptoms, and coping mechanisms (behavioral disengagement and self-blame']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",371.0,0.0461738,"The multifaceted iENGAGE intervention is effective in reducing internalized stigma for new-to-HIV care individuals, especially with higher depressive symptoms or when using higher levels of self-blame coping.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Yigit', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Riddhi A', 'Initials': 'RA', 'LastName': 'Modi', 'Affiliation': 'Department of Pathology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sheri D', 'Initials': 'SD', 'LastName': 'Weiser', 'Affiliation': 'Division of HIV, ID and Global Medicine, Department of Medicine.'}, {'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Division of Infectious Diseases, School of Medicine.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Turan', 'Affiliation': 'Department of Psychology.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002566']
2122,32881797,A multilevel intervention to reduce stigma among alcohol consuming men living with HIV receiving antiretroviral therapy: findings from a randomized control trial in India.,"OBJECTIVE


To examine the effectiveness of a multilevel intervention to reduce HIV stigma among alcohol consuming men living with HIV in India.
DESIGN


A crossover randomized controlled trial in four sites.
SETTING


Government ART centres (ARTCs) offering core services in the greater Mumbai area.
PARTICIPANTS


Seven hundred and fifty two (188 per site) alcohol-consuming male PLHIV on ART were recruited.
INTERVENTION


Multilevel intervention to reduce alcohol consumption and promote adherence by addressing stigma, implemented at the individual (individual counselling, IC), group (group intervention, GI) and community levels (collective advocacy, CA) in three distinct sequences over three cycles of 9 months each.
MAIN OUTCOME MEASURE


HIV stigma, measured using the 16-item Berger Stigma scale.
METHODS


The article examines the effectiveness of the interventions to reduce stigma using Linear Mixed Model regression.
RESULTS


At baseline, 57% of participants had moderate-high levels of stigma (scores >40). All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy: βcoeff = -9.71; p < 0.001; group intervention: βcoeff = -5.22; p < 0.001; individual counselling: βcoeff = -4.43; p < 0.001). At then end of the second cycle, effects from the first cycle were sustained with no significant change in stigma scores. At the end of the third cycle, the site, which received CA+IC+GI sequence had maximum reduction in stigma scores (βcoeff = -10.29; p < 0.001), followed by GI+CA+IC (βcoeff = -8.23, p < 0.001).
CONCLUSION


Baseline findings suggest that stigma remains a problem even with experienced patients, despite advances in treatment and adherence. Results of multilevel stigma reduction interventions argue for inclusion in HIV prevention and treatment program.",2020,"All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy:","['Government ART centres (ARTCs) offering core services in the greater Mumbai area', 'consuming men living with HIV in India', 'Seven hundred and fifty two (188 per site) alcohol-consuming male PLHIV on ART were recruited', 'consuming men living with HIV receiving antiretroviral therapy']","['alcohol', 'multilevel intervention', 'Multilevel intervention to reduce alcohol consumption and promote adherence by addressing stigma, implemented at the individual (individual counselling, IC), group (group intervention, GI) and community levels (collective advocacy, CA']","['stigma scores', 'HIV stigma, measured using the 16-item Berger Stigma scale', 'moderate-high levels of stigma', 'HIV stigma']","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",752.0,0.0978675,"All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy:","[{'ForeName': 'Roopal J', 'Initials': 'RJ', 'LastName': 'Singh', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Avina', 'Initials': 'A', 'LastName': 'Sarna', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Jean J', 'Initials': 'JJ', 'LastName': 'Schensul', 'Affiliation': 'Institute for Community Research, Hartford.'}, {'ForeName': 'Bidhubhushan', 'Initials': 'B', 'LastName': 'Mahapatra', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Ha', 'Affiliation': 'University of Connecticut, School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Schensul', 'Affiliation': 'University of Connecticut, School of Medicine, Farmington, Connecticut, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002604']
2123,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
2124,32883736,Recipient and instructor perspectives of an adapted exercise-based fall prevention programme for adults aged 50+ years with vision impairment: a qualitative study nested within a randomised controlled trial.,"OBJECTIVE


Older adults with vision impairment currently have no access to tailored fall prevention programmes. Therefore, the purpose of this study, nested within an ongoing randomised controlled trial (RCT), is to document the adaptation of an existing fall prevention programme and investigate the perspectives of instructors involved in delivery and the older adults with vision impairment receiving the programme (recipients).
DESIGN


We documented programme adaptations and training requirements, and conducted semistructured, individual interviews with both the instructors and the recipients of the programme from 2017 to 2019. The content of each interview was analysed using behaviour change theory through deductive qualitative analysis.
SETTING


New South Wales and Australian Capital Territory, Australia.
PARTICIPANTS


The 11 trained instructors interviewed were employees of a vision rehabilitation organisation and had delivered at least one programme session as part of the RCT. The 154 recipients interviewed were community-dwelling adults aged ≥50 years with vision impairment and no diagnosis of dementia, and had completed their participation in the programme as part of the intervention group of the RCT.
RESULTS


Six key themes were identified relating to recipient (delivery aptitude, social norms, habit formation) and instructor (individualised adaptation, complimentary to scope of practice, challenges to delivery) perspectives. With initial training, instructors required minimal ongoing support to deliver the programme and made dynamic adaptations to suit the individual circumstances of each recipient, but cited challenges delivering the number of programme activities required. Recipient perspectives varied; however, most appreciated the delivery of the programme by instructors who understood the impact of vision impairment.
CONCLUSIONS AND IMPLICATIONS


This novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.
TRIAL REGISTRATION NUMBER


ACTRN12616001186448.",2020,"This novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.
","['older adults with vision impairment receiving the programme (recipients', 'New South Wales and Australian Capital Territory, Australia', 'adults aged 50+ years with vision impairment', '154 recipients interviewed were community-dwelling adults aged ≥50 years with vision impairment and no diagnosis of dementia, and had completed their participation in the programme as part of the intervention group of the RCT', 'Older adults with vision impairment', 'older people with vision impairment', 'The 11 trained instructors interviewed were employees of a vision rehabilitation organisation and had delivered at least one programme session as part of the RCT']",['adapted exercise-based fall prevention programme'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0454764', 'cui_str': 'Australian Capital Territory'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}]",[],,0.0590725,"This novel qualitative study demonstrates that the adapted programme, delivered by instructors, who already have expertise delivering individualised programmes to older people with vision impairment, may fill the gap for a fall prevention programme in this population.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dillon', 'Affiliation': 'School of Optometry and Vision Science, Faculty of Science, University of New South Wales, Sydney, New South Wales, Australia lisa.dillon1@unsw.edu.au.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Ageing, Work and Health Research Unit, University of Sydney, Sydney, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Nguyen', 'Affiliation': 'School of Optometry and Vision Science, Faculty of Science, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten Bonrud', 'Initials': 'KB', 'LastName': 'Jakobsen', 'Affiliation': 'Injury Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Client Services, Guide Dogs NSW/ACT, Sydney, New South Wales, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Tinsley', 'Affiliation': 'Client Services, Guide Dogs NSW/ACT, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Keay', 'Affiliation': 'School of Optometry and Vision Science, Faculty of Science, University of New South Wales, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038386']
2125,32883738,Mitigating the mistreatment of childbearing women: evaluation of respectful maternity care intervention in Ethiopian hospitals.,"OBJECTIVES


There is a lack of evidence on approaches to mitigating mistreatment during facility-based childbirth. This study compares the experiences of mistreatment reported by childbearing women before and after implementation of a respectful maternity care intervention.
DESIGN


A pre-post study design was undertaken to quantify changes in women's experiences of mistreatment during facility-based childbirth before and after the respectful maternity care intervention.
INTERVENTION


A respectful maternity care intervention was implemented in three hospitals in southern Ethiopia between December 2017 and September 2018 and it included training of service providers, placement of wall posters in labour rooms and post-training supportive visits for quality improvement.
OUTCOME MEASURES


A 25-item questionnaire asking women about mistreatment experiences was administered to 388 women (198 in the pre-intervention, 190 in the post-intervention). The outcome variable was the number of mistreatment components experienced by women, expressed as a score out of 25. Multilevel mixed-effects Poisson modelling was used to assess the change in mistreatment score from pre-intervention to post-intervention periods.
RESULTS


The number of mistreatment components experienced by women was reduced by 18% when the post-intervention group was compared with the pre-intervention group (adjusted regression coefficient (Aβ)=0.82, 95% CI 0.74 to 0.91). Women who had a complication during pregnancy (Aβ=1.17, 95% CI 1.01 to 1.34) and childbirth (Aβ=1.16, 95% CI 1.03 to 1.32) experienced a greater number of mistreatment components. On the other hand, women who gave birth by caesarean birth after trial of vaginal birth (Aβ=0.76, 95% CI 0.63 to 0.92) and caesarean birth without trial of vaginal birth (Aβ=0.68, 95% CI 0.47 to 0.98) experienced a lesser number of mistreatment components compared with those who had vaginal birth.
CONCLUSIONS


Women reported significantly fewer mistreatment experiences during childbirth following implementation of the intervention. Given the variety of factors that lead to mistreatment in health facilities, interventions designed to mitigate mistreatment need to involve structural changes.",2020,"The number of mistreatment components experienced by women was reduced by 18% when the post-intervention group was compared with the pre-intervention group (adjusted regression coefficient (Aβ)=0.82, 95% CI 0.74 to 0.91).","['388 women (198 in the pre-intervention, 190 in the post-intervention', ""women's experiences of mistreatment during facility-based childbirth before and after the respectful maternity care intervention"", 'three hospitals in southern Ethiopia between December 2017 and September 2018 and it included training of service providers, placement of wall posters in labour rooms and post-training supportive visits for quality improvement', 'childbearing women', 'Ethiopian hospitals']",['respectful maternity care intervention'],"['caesarean birth without trial of vaginal birth', 'number of mistreatment components', 'childbirth', 'complication during pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.125885,"The number of mistreatment components experienced by women was reduced by 18% when the post-intervention group was compared with the pre-intervention group (adjusted regression coefficient (Aβ)=0.82, 95% CI 0.74 to 0.91).","[{'ForeName': 'Anteneh', 'Initials': 'A', 'LastName': 'Asefa', 'Affiliation': 'School of Public Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia antex98@yahoo.com.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samson', 'Initials': 'S', 'LastName': 'Gebremedhin', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Tekle', 'Affiliation': 'Maternal and Child Health Directorate, Ministry of Health, Addis Ababa, Ethiopia.'}, {'ForeName': 'Sintayehu', 'Initials': 'S', 'LastName': 'Abebe', 'Affiliation': 'Amref Health Africa in Ethiopia, Addis Ababa, Ethiopia.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Magge', 'Affiliation': 'Institute for Healthcare Improvement, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kermode', 'Affiliation': 'Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038871']
2126,32887558,A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.,"BACKGROUND


Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH.
METHODS


This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling.
RESULTS


Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: - 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
CONCLUSIONS


YPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.",2020,"Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
","['young people living with HIV in Tanzania', 'Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis', 'Mean age was 18.1\u2009years; 51% were female; and 84% were HIV-infected perinatally', 'young people living with HIV (YPLWH']","['A group-based mental health intervention', 'YPLWH', 'Tanzania-based SYV intervention', 'mental health intervention, Sauti ya Vijana (SYV', 'local standard-of-care (SOC']","['ART adherence and virologic outcomes', 'Feasibility and acceptability', 'Virologic suppression rates', 'mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA', 'ART adherence and virologic suppression', 'ART concentration values']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.18628,"Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
","[{'ForeName': 'Dorothy E', 'Initials': 'DE', 'LastName': 'Dow', 'Affiliation': 'Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA. Dorothy.dow@duke.edu.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, USA.'}, {'ForeName': 'Coleen K', 'Initials': 'CK', 'LastName': 'Cunningham', 'Affiliation': 'Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': ""O'Donnell"", 'Affiliation': 'Duke University, Center for Health Policy and Inequalities Research, Durham, NC, USA.'}]",BMC public health,['10.1186/s12889-020-09380-3']
2127,32887570,A health concept with a social potential: an interview study with nursing home residents.,"BACKGROUND


A qualitative, interview-based study was embedded in a randomized intervention trial, the Older People Exercise and Nutrition (OPEN) study. Participants in the OPEN study were encouraged to conduct sessions of sit-to-stand (STS) exercises combined with Oral Nutritional Supplements (ONS) intake. The aim was to describe the older persons' perceptions and experiences of being given the daily opportunity to perform the STS exercise and drink ONS.
METHODS


In-depth interviews were conducted in six nursing homes with the participants using a semi-structured interview guide. One or two individual interviews were performed with each included participant. Twenty-three NH residents (16 women and 7 men) participated in the qualitative study. Their ages ranged between 76 and 96 years, and their Mini Mental State Examination (MMSE) scored between 8 and 29. The transcribed interviews and field notes written during the visits were analyzed inductively following a constant comparative method described in Grounded Theory.
RESULTS


The exercise and nutritional intervention was described as highly practical by the NH residents, who claimed it also had a social aspect as they felt acknowledged and empowered to engage others in the combined intervention. Experiences of the intervention ranged from neutral to mainly positive and could be sorted into 5 categories: 1. Perceived hopes and expectations, 2. Health-related driving forces, 3. Appreciated daily activities, 4. A concept easy to perform and integrate into daily life, 5. A beneficial health concept for all. The intervention created perceived benefits on various health aspects due to participants feeling energized and stronger. An overall theme was identified as A health concept with a social potential, as participants feel acknowledged and strong enough to help others.
CONCLUSIONS


The intervention was described by participants as a health concept that could potentially be beneficial for a broader spectrum of NH residents. The findings indicate that health concepts, such as STS/ONS, might contribute to a more meaningful day for older people, even vulnerable NH residents approaching the end of life.
TRIAL REGISTRATION


ClinicalTrials.govIdentifier: NCT02702037 . Date of trial registration February 26, 2016.",2020,"The exercise and nutritional intervention was described as highly practical by the NH residents, who claimed it also had a social aspect as they felt acknowledged and empowered to engage others in the combined intervention.","['Twenty-three NH residents (16 women and 7 men) participated in the qualitative study', 'six nursing homes with the participants using a semi-structured interview guide', 'nursing home residents', 'Older People Exercise and Nutrition (OPEN) study', 'Their ages ranged between 76 and 96\u2009years, and their Mini Mental State Examination (MMSE) scored between 8 and 29']","['STS exercise and drink ONS', 'conduct sessions of sit-to-stand (STS) exercises combined with Oral Nutritional Supplements (ONS) intake']",[],"[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",[],,0.0217036,"The exercise and nutritional intervention was described as highly practical by the NH residents, who claimed it also had a social aspect as they felt acknowledged and empowered to engage others in the combined intervention.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Vikström', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Occupational Therapy, Karolinska Institutet, Stockholm, Sweden. sofia.vikstrom@ki.se.'}, {'ForeName': 'Helena K', 'Initials': 'HK', 'LastName': 'Grönstedt', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Franzén', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Seiger', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Faxén-Irving', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boström', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}]",BMC geriatrics,['10.1186/s12877-020-01731-4']
2128,32887637,Evaluation of an intervention aimed at supporting new parents: the Baby Newsletter project.,"BACKGROUND


Anticipatory guidance for parents is commonly used to improve parenting skills. The objective of this pre/post-intervention controlled study was to evaluate the effectiveness of a periodic newsletter with advice on childcare and development in improving parenting self-efficacy.
METHODS


This was a non-randomized pre/post-intervention controlled study. All the parents of children born between September 2014 and December 2015 resident in the S. Ilario d'Enza municipality (Italy) received eight Baby Newsletters. Parents resident in other municipalities of the same Health District were the control. Parents with linguistic barriers or with preterm or hospitalized children were excluded. Improvement in parenting self-efficacy was measured through the TOPSE (Tool to Measure Parenting Self-Efficacy) questionnaire during the first week (t0) after delivery and at 5 (t1) and 12 months (t2) of life at two vaccination appointments. A score ranging from 0 to 60 was computed for each of the eight domains investigated by the TOPSE. Variations of each TOPSE score between delivery and 12 months in the two groups were compared, adjusting for parity, education, age of parents, and child's sex, and stratifying by parity and education.
RESULTS /FINDINGS


One hundred thirty-six families accepted to participate in the study. Scores at 12 months were higher than 1 week after delivery in both groups for all TOPSE domains. The improvement was slightly stronger in the Newsletter group for almost all the skills except learning and knowledge [difference in the mean of variation: -0.48 (95% CI: - 3.17; 2.21)]; the difference was significant only for play and enjoyment [2.18 (95% CI: 0.12; 4.25)]. The increase in scores in almost all domains was more pronounced for parents with high education level at first child.
CONCLUSIONS


The intervention was effective in improving parents' ability to play. However, it risks worsening existing differences between parents with high and with low education levels.
TRIAL REGISTRATION


Clinical trial registration: NCT03268408 .",2020,The improvement was slightly stronger in the Newsletter group for almost all the skills except learning and knowledge [difference in the mean of variation:,"[""parents of children born between September 2014 and December 2015 resident in the S. Ilario d'Enza municipality (Italy) received"", 'One hundred thirty-six families accepted to participate in the study', 'Parents with linguistic barriers or with preterm or hospitalized children']","['eight Baby Newsletters', 'TOPSE']","['Parenting Self-Efficacy) questionnaire', 'parenting self-efficacy', 'TOPSE score', 'mean of variation']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",136.0,0.0461917,The improvement was slightly stronger in the Newsletter group for almost all the skills except learning and knowledge [difference in the mean of variation:,"[{'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Panza', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Volta', 'Affiliation': 'Primary Care Service, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Broccoli', 'Affiliation': 'Epidemiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonvicini', 'Affiliation': 'Epidemiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. laura.bonvicini@ausl.re.it.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kendall', 'Affiliation': 'Centre for Health Services Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Marchesi', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giorgi Rossi', 'Affiliation': 'Epidemiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}]",Italian journal of pediatrics,['10.1186/s13052-020-00886-5']
2129,32887653,"Effect of chemoprevention by low-dose aspirin of new or recurrent colorectal adenomas in patients with Lynch syndrome (AAS-Lynch): study protocol for a multicenter, double-blind, placebo-controlled randomized controlled trial.","Lynch syndrome (LS) is the most common cause of inherited colorectal cancer (CRC) and confers a high lifetime risk of CRC estimated to be up to 60%. Colonoscopy is recommended every 2 years in LS patients above the 20-25-year-old age bracket, and every year when colonic neoplasia has been detected. Efficient chemoprevention has the potential to represent a cost-effective intervention in these high-risk patients and could allow a delay in colonoscopy surveillance. Several epidemiological studies have shown that regular use of low dose aspirin is associated with a 20 to 30% reduction in the risk of sporadic colonic adenomas and colorectal cancer regardless of family risk. However, in recent large randomized trials in specific populations, aspirin use showed no protection for colorectal cancer. A prospective randomized CAPP-2 trial evaluated the effect of aspirin use in LS patients. The primary analysis of this trial showed no significant decrease in CRC in LS patients under daily aspirin. However, a preplanned secondary analysis after an extended follow-up showed a significant reduced risk of CRC in the aspirin group in the per-protocol analysis. The real effect and clinical benefit of aspirin are still to be consolidated in this population. The AAS-Lynch trial-a prospective, multicentric, double-blind, placebo-controlled, randomized clinical trial-was designed to investigate if daily aspirin therapy, at a dose of 100 or 300 mg, would decrease the occurrence or recurrence of colorectal adenomas in patients under 75 years of age, compared with placebo. TRIAL REGISTRATION: ClinicalTrials.gov NCT02813824 . Registered on 27 June 2016. The trial was prospectively registered.",2020,The primary analysis of this trial showed no significant decrease in CRC in LS patients under daily aspirin.,"['LS patients', 'patients under 75\u2009years of age, compared with', 'patients with Lynch syndrome (AAS-Lynch']","['aspirin therapy', 'placebo', 'chemoprevention by low-dose aspirin', 'aspirin']","['CRC', 'occurrence or recurrence of colorectal adenomas', 'risk of CRC']","[{'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.409244,The primary analysis of this trial showed no significant decrease in CRC in LS patients under daily aspirin.,"[{'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Soualy', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Deutsch', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Benallaoua', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Ait-Omar', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Mary', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Helfen', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Boubaya', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Levy', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Benamouzig', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France. robert.benamouzig@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04674-8']
2130,32888192,Continuous intravenous infusion of enoxaparin controls thrombin formation more than standard subcutaneous administration in critically ill patients. A sub-study of the ENOKSI thromboprophylaxis RCT.,"INTRODUCTION


Standard subcutaneous low-molecular-weight heparin (LMWH) thromboprophylaxis yields low anti-factor Xa activity in patients in the intensive care unit (ICU). The aim of the study was to assess coagulation status in ICU patients randomized to receive enoxaparin thromboprophylaxis either as a standard subcutaneous bolus (SCB) or continuous intravenous infusion (CII) for 3 consecutive days after the initiation of LMWH thromboprophylaxis.
MATERIALS AND METHODS


Thirty-eight patients were studied by conventional coagulation variables: prothrombin fragment F 1+2 (F 1+2) representing FXa inhibition and antithrombin (AT). Additionally, 18 patients were analyzed by the thrombin generation assay-calibrated automated thrombogram (TGA-CAT). Blood samples were collected before the initiation of the LMWH thromboprophylaxis (ie, baseline), at 51 h, and at 72 h.
RESULTS


At beginning, no differences in coagulation biomarkers were observed. The levels of F 1+2 were significantly lower at 51 and 72 h in the CII group than in the SCB group. AT levels increased during the follow-up in the CII group, unlike in the SCB group. TGA-CAT was poor in some patients overall. In a subset of patients at 51 h lag time (4.3 vs 7.5 min, respectively, P < 0.05) and time to peak (7.7 vs 14.3 min, respectively, P < 0.05) were prolonged in the SCB group. At 72 h, however, peak thrombin was lower in the CII than in the SCB group: 271 vs 356 nM, respectively (P < 0.05).
CONCLUSIONS


Enoxaparin thromboprophylaxis administered by CII inhibited more prominently FXa and preserved better the AT level, compared with standard subcutaneous care.",2020,The levels of F 1+2 were significantly lower at 51 and 72 h in the CII group compared than in the SCB group.,"['Thirty-eight patients were studied by', 'ICU patients', 'patients in the intensive care unit (ICU', 'critically ill patients']","['enoxaparin controls thrombin formation', 'enoxaparin thromboprophylaxis', 'conventional coagulation variables: prothrombin fragment F 1+2 (F 1+2) representing FXa inhibition and antithrombin (AT', 'heparin (LMWH) thromboprophylaxis yields', 'SCB', 'Enoxaparin thromboprophylaxis']","['coagulation status', 'AT levels', 'time to peak', 'peak thrombin', 'levels of F 1+2', 'Blood samples', 'coagulation biomarkers', 'low anti-factor Xa activity', 'thrombin generation assay-calibrated automated thrombogram (TGA-CAT']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0033706', 'cui_str': 'Prothrombin'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]",38.0,0.0327543,The levels of F 1+2 were significantly lower at 51 and 72 h in the CII group compared than in the SCB group.,"[{'ForeName': 'Annukka', 'Initials': 'A', 'LastName': 'Vahtera', 'Affiliation': 'Department of Intensive Care Medicine, Tampere University Hospital, PO Box 2000, Tampere, 33521, Finland.'}, {'ForeName': 'Timea', 'Initials': 'T', 'LastName': 'Szanto', 'Affiliation': 'Coagulation Disorders Unit, Department of Clinical Chemistry, HUSLAB Laboratory Services, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Lassila', 'Affiliation': 'Coagulation Disorders Unit, Department of Clinical Chemistry, HUSLAB Laboratory Services, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Valkonen', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mirka', 'Initials': 'M', 'LastName': 'Sivula', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, University of Tampere, Tampere, 33014, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kuitunen', 'Affiliation': 'Department of Intensive Care Medicine, Tampere University Hospital, PO Box 2000, Tampere, 33521, Finland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13697']
2131,32888343,The impact of survey mode on US national estimates of adolescent drug prevalence: results from a randomized controlled study.,"BACKGROUND AND AIMS


Increasing numbers of school-based drug surveys are transitioning data collection to electronic tablets from paper-and-pencil, which may produce a survey mode effect and consequent discontinuity in time trends for population estimates of drug prevalence. This study tested whether (a) overall, self-reported drug use prevalence is higher on electronic tablets versus paper-and-pencil surveys, (b) socio-demographics moderate survey mode effects and (c) levels of missing data are lower for electronic tablet versus paper-and-pencil modes.
DESIGN


A randomized controlled experiment.
SETTING


Results are nationally representative of students in the contiguous United States.
PARTICIPANTS


A total of 41 866 8th, 10th and 12th grade students who participated in the 2019 Monitoring the Future school-based survey administration.
INTERVENTION AND COMPARATOR


Surveys were administered to students in a randomly selected half of schools with electronic tablets (intervention) and with paper-and-pencil format (comparator) for the other half.
MEASUREMENTS


Primary outcome was the total number of positive drug use responses. Secondary outcomes were the percentage of respondents completing all drug questions, percentage of drug questions unanswered and mean number of missing drug items.
FINDINGS


The relative risk (RR) for total number of positive drug use responses for electronic tablets versus paper-and-pencil surveys were small and their 95% confidence intervals (CI) included the value of one for reporting intervals of life-time (RR = 1.03; 95% CI, 0.93-1.14), past 12 months (RR = 1.01; 95% CI, 0.91-1.11), past 30 days (RR = 1.05; 95% CI, 0.93-1.20) and for heavy use (RR = 1.10; 95% CI, 0.93-1.29). Multiplicative interaction tests indicated no moderation of these relative risks by race (white versus non-white), population density, census region, public/private school, year of school participation, survey version or non-complete drug responses. Levels of missing data were significantly lower for electronic tablets versus paper-and-pencil surveys.
CONCLUSIONS


Adolescent drug prevalence estimates in the United States differed little across electronic tablet versus paper-and-pencil survey modes, and showed little to no effect modification by socio-demographics. Levels of missing data were lower for electronic tablets.",2020,"Multiplicative interaction tests indicated no moderation of these relative risks by race (white v. nonwhite), population density, census region, public/private school, year of school participation, survey version, or non-complete drug responses.","['41,866 8th, 10th, and 12th grade students who participated in the 2019 Monitoring the Future school-based survey administration', 'Results are nationally-representative of students in the contiguous United States', 'Adolescent Drug Prevalence']",['electronic tablets (intervention) and with paper-and-pencil format (comparator) for the other half'],"['total number of positive drug use responses', 'percent of respondents completing all drug questions, percent of drug questions unanswered, and mean number of missing drug items', 'Levels of missing data']","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205283', 'cui_str': 'Contiguous'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",41866.0,0.149561,"Multiplicative interaction tests indicated no moderation of these relative risks by race (white v. nonwhite), population density, census region, public/private school, year of school participation, survey version, or non-complete drug responses.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Miech', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Mick P', 'Initials': 'MP', 'LastName': 'Couper', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Heeringa', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15249']
2132,32889172,Validation of local p16 testing for determination of human papilloma virus status eligibility on a low risk oropharyngeal cancer trial - A Trans-Tasman Radiation Oncology Group study.,"OBJECTIVE


Accurate determination of human papilloma virus (HPV) status is critical when identifying patients with oropharyngeal squamous cell carcinoma (OPSCC) who may be candidates for de-escalation trials. In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
METHODS AND MATERIALS


Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC were randomised based on local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing. Correlations between the local and central p16 and central HPV RNA ISH were studied. The main outcome was the positive predictive value (PPV) of local pathology laboratory testing of p16.
RESULTS


176/182 patients had samples available for central testing. 172/176 were evaluable for central testing of p16, and all were confirmed to be p16 positive (172/172, 100%, 95% CI = [97.9%, 100%]). Similarly, 100% of those evaluable for HPV RNA ISH (155/155, 100%, 95% CI = [97.6%, 100%]) were confirmed HPV positive, indicating p16 overexpression driven by transcriptionally active HPV and a PPV of 100% for local p16 testing.
CONCLUSIONS


Our results validate the suitability of local pathology laboratory p16 testing alone, in populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials. This obviates the need for upfront more complex and expensive HPV assays and/or central laboratory testing.",2020,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","['populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials', 'patients with oropharyngeal squamous cell carcinoma (OPSCC', 'Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC', '176/182 patients had samples available for central testing']",['local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing'],"['positive predictive value (PPV) of local pathology laboratory testing of p16', 'local and central p16 and central HPV RNA ISH', 'HPV RNA ISH']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0020202', 'cui_str': 'Hybridization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.269323,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Angel', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Radiation Oncology Centres, Gold Coast, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104988']
2133,32889324,Predict overall survival of spinal conventional chordoma: Development and assessment of a new predictive nomogram.,"OBJECTIVE


To predict the 5-year overall survival (OS) rate in patients with conventional chordoma of the spine PATIENTS AND METHODS: The Surveillance, Epidemiology, and End Results (SEER) Registry was used to identify patients with conventional chordoma of the spine from 1994 to 2013. The entire cohort(n = 294) was randomly divided into training (n = 147) and validation (n = 147) cohorts to construct a nomogram. We used the univariate Log-rank test and multivariate Cox model to examine the independent prognostic factors associated with OS. These prognostic factors were integrated to construct a nomogram through R studio. The predictive and validating capacity of the nomogram was calculated by Harrell's concordance index (C-index) and calibration curves.
RESULTS


A total of 294 patients were identified with conventional chordoma of the spine. The patients' age at diagnosis, tumor size, EOD (extent of disease), and treatment were independent prognostic factors and associated with OS. These prognostic factors were incorporated to construct a nomogram. The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively. Internal and external calibration curves for 5-year OS showed excellent matching between nomogram prediction and observed outcomes.
CONCLUSIONS


The findings of this study provide population-based estimates of patients with conventional chordoma of the spine. Using this nomogram, surgeons can classify patients into different risk groups and achieve individualized treatment.",2020,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","['patients with conventional chordoma of the spine', 'patients with conventional chordoma of the spine from 1994 to 2013', '294 patients were identified with conventional chordoma of the spine']",[],"['Surveillance, Epidemiology, and End Results (SEER', '5-year overall survival (OS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008487', 'cui_str': 'Chordoma'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",294.0,0.0249893,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","[{'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedic Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Kehan', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shengxing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Libo', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huiren', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: wang.huiren@zs-hospital.sh.cn.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: dong.jian@zs-hospital.sh.cn.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106174']
2134,32914554,Synthetic media for preservation of corneal tissues deemed for endothelial keratoplasty and endothelial cell culture.,"PURPOSE


To compare the difference between various endothelial graft preparation methods and endothelial cell culture from tissues that are preserved in serum-based and synthetic medium.
METHODS


In a randomized masked study, the tissues (n = 64) were preserved in Cornea Max (serum-based) and Cornea Syn (synthetic) series for 36 days at their respective preservation conditions. Following organ culture, corneal tissues (n = 48) were used to prepareDescemet stripping automated endothelial keratoplasty (DSAEK), preloaded ultra-thin (UT) -DSAEK, prestripped Descemet membrane endothelial keratoplasty (DMEK), free-floating DMEK, and preloaded DMEK with endothelium inward and outward grafts. These tissues were preserved for another 4days at room temperature in dextran supplemented media following which they were subjected to trypan blue, alizarin red, live/dead and Zonula Occludens-1 (ZO-1) staining. A separate set of tissues (n = 16) from both the series was used for human corneal endothelial cell (HCEnC) culture. At confluence, the proliferation and cell doubling rate was calculated and the cultured cells were subjected to live/dead, ZO-1, 2A12 and Ki-67 staining. Mann-Whitney test was performed with p < 0.05 deemed statistically significant.
RESULTS


After preparation and preservation of the tissues for endothelial keratoplasty, alizarin red showed standard endothelial morphology from both the groups. Endothelial cell loss, hexagonality and uncovered areas did not show statistically significant differences (p > 0.05) between both groups. For HCEnC, cell doubling rate was 4.7 days (p > 0.05). All the antibodies were expressed in both the groups. Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity were not statistically significant (p > 0.05).
CONCLUSIONS


Complete synthetic organ culture series is safe and advantageous for carrying out advanced endothelial keratoplasty graft preparation procedures and for HCEnC culture as it is free from animal or animal-derived products.",2020,"Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity were not statistically significant (p > 0.05).
",[],"['prepareDescemet stripping automated endothelial keratoplasty (DSAEK), preloaded ultra-thin (UT) -DSAEK']","['Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity', 'proliferation and cell doubling rate', 'Cornea Max (serum-based) and Cornea Syn (synthetic) series', 'Endothelial cell loss, hexagonality']",[],"[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C0205168', 'cui_str': 'Thin'}]","[{'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}]",64.0,0.0309539,"Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity were not statistically significant (p > 0.05).
","[{'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Parekh', 'Affiliation': 'Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ruzza', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gallon', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ponzin', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}]",Acta ophthalmologica,['10.1111/aos.14583']
2135,32915027,Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation.,"The current opioid crisis was fueled by escalation of opioid dosing among patients with chronic pain. Yet, there are few evidence-based psychological interventions for opioid dose reduction among chronic pain patients treated with long-term opioid analgesics. Mindfulness-Oriented Recovery Enhancement (MORE), which was designed to target mechanisms underpinning chronic pain and opioid misuse, has shown promising results in 2 randomized clinical trials (RCTs) and could facilitate opioid sparing and tapering by bolstering self-regulation. Here we tested this hypothesis with secondary analyses of data from a Stage 2 RCT. Chronic pain patients (N = 95) on long-term opioid therapy were randomized to 8 weeks of MORE or a support group (SG) control delivered in primary care. Opioid dose was assessed with the Timeline Followback through 3-month follow-up. Heart rate variability (HRV) during mindfulness meditation was quantified as an indicator of self-regulatory capacity. Participants in MORE evidenced a greater decrease in opioid dosing (a 32% decrease) by follow-up than did the SG, F(2, 129.77) = 5.35, p = .006, d = 1.07. MORE was associated with a significantly greater increase in HRV during meditation than was the SG. Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034). MORE may boost self-regulatory strength via mindfulness and thereby facilitate self-control over opioid use, leading to opioid dose reduction in people with chronic pain. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"['people with chronic pain', 'chronic pain patients treated with long-term opioid analgesics', 'Chronic pain patients (N = 95) on long-term opioid therapy', 'patients with chronic pain']","['MORE or a support group (SG) control delivered in primary care', 'Mindfulness-Oriented Recovery Enhancement (MORE']","['Heart rate variability (HRV', 'HRV']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0780555,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hudak', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}]",The American psychologist,['10.1037/amp0000638']
2136,32915236,Effect of Peer Mentors in Diabetes Self-management vs Usual Care on Outcomes in US Veterans With Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Diabetes is a substantial public health issue. Peer mentoring is a low-cost intervention for improving glycemic control in patients with diabetes. However, long-term effects of peer mentoring and creation of sustainable models are not well studied.
Objective


Assess the effects of a peer support intervention for improving glycemic control in patients with diabetes and evaluate a model in which former mentees serve as mentors.
Design, Setting, and Participants


A randomized clinical trial was conducted from September 27, 2012, to March 21, 2018, at the Corporal Michael J. Crescenz Medical Center. US veterans with type 2 diabetes aged 30 to 75 years with hemoglobin A1C (HbA1c) greater than 8% received support over 6 months from peers with prior poor glycemic control but who had achieved HbA1c less than or equal to 7.5% (phase 1). Phase 1 mentees were then randomized to become a mentor or not to new randomly assigned participants in phase 2. Outcomes were assessed at 6 and 12 months. Data were analyzed from October 5, 2016, to September 4, 2018.
Interventions


Mentors who received an initial training session and monthly reinforcement training were assigned 1 mentee and given $20 for each month they contacted their mentee at least weekly.
Main Outcomes and Measures


Primary outcome was HbA1c change at 6 months. Secondary outcomes included HbA1c change at 12 months and change in low-density lipoprotein, blood pressure, diabetes quality of life, and depression symptoms at 6 and 12 months.
Results


The study enrolled 365 participants into phase 1 and 122 participants into phase 2. Most participants were Black (341 [66%]) and male (454 [96%]), with a mean (SD) age of 60 (7.5) years. Mean phase 1 HbA1c change at 6 months for usual care was -0.20% (95% CI, -0.46% to 0.06%) vs -0.52% (95% CI, -0.76% to -0.29%) for mentees (P = .06). Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16). There were no differences in secondary outcomes or HbA1c levels at 12 months. There was no benefit to past mentees who became mentors.
Conclusions and Relevance


In this randomized clinical trial, a peer mentor intervention did not improve 6-month HbA1c levels and did not have sustained benefits.
Trial Registration


ClinicalTrials.gov Identifier: NCT01651117.",2020,"Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16).","['US Veterans With Type 2 Diabetes', 'Diabetes', '365 participants into phase 1 and 122 participants into phase 2', 'Most participants were Black (341 [66%]) and male (454 [96%]), with a mean (SD) age of 60 (7.5) years', 'September 27, 2012, to March 21, 2018, at the Corporal Michael J. Crescenz Medical Center', 'patients with diabetes', 'US veterans with type 2 diabetes aged 30 to 75 years with hemoglobin A1C (HbA1c) greater than 8% received support over 6 months from peers with prior poor glycemic control but who had achieved HbA1c less than or equal to 7.5% (phase 1', 'patients with diabetes and evaluate a model in which former mentees serve as mentors']","['Self-management vs Usual Care', 'Peer Mentors', 'Peer mentoring', 'peer support intervention', 'initial training session and monthly reinforcement training']","['secondary outcomes or HbA1c levels', 'HbA1c change at 6 months', '6-month HbA1c levels', 'HbA1c change at 12 months and change in low-density lipoprotein, blood pressure, diabetes quality of life, and depression symptoms']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",365.0,0.150273,"Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16).","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, VA Center for Health Equity Research and Promotion, Philadelphia, Pennsylvania.'}, {'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Ganetsky', 'Affiliation': 'Division of Addiction Medicine and Urban Health Institute, Cooper University Hospital, Camden, New Jersey.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Canamucio', 'Affiliation': 'Veterans Integrated Service Network 4, Center for Evaluation of PACT, Philadelphia, Pennsylvania.'}, {'ForeName': 'Tanisha N', 'Initials': 'TN', 'LastName': 'Dicks', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, VA Center for Health Equity Research and Promotion, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'School of Social Policy and Practice, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16369']
2137,32915325,"Percutaneous trans-ulnar versus trans-radial arterial approach for coronary angiography and angioplasty, a preliminary experience at an Egyptian cardiology center.","BACKGROUND


Trans-ulnar approach was proposed primarily for elective procedures in patients not suitable for trans-radial approach that was introduced two decades ago. The trans-ulnar approach is as safe and effective as the trans-radial approach for coronary angiography and intervention.
AIM


This study's aim was to assess the feasibility and safety of the trans-ulnar approach in coronary procedures as a preliminary experience for operators experienced in trans-radial approach with no/minimal trans-ulnar approach experience at an Egyptian center.
RESULTS


Vascular access in 120 patients was selected randomly for coronary angiography and angioplasty-80 through radial and 40 through ulnar approach. Patients were examined for local complications and Doppler evaluation to both radial and ulnar arteries a day after the procedure was done. Ulnar approach success was 82.5% versus 93.7% in the radial group; failure of ulnar artery puncture was the only cause of crossover in the ulnar group, while occurrence of persistent spasm was the leading cause of crossover in the radial group followed by radial artery tortuosity. The procedure time of coronary angiography and percutaneous coronary intervention of the ulnar group was significantly higher than that of the radial group (P value = 0.011 and 0.034, respectively). The mean caliber of the right ulnar artery was 2.45 ± 0.38, slightly larger than that of the radial artery 2.33 ± 0.38 at the level of the wrist, but this difference was statistically non-significant.
CONCLUSION


Our study demonstrated that ulnar access with experienced radial operators and in our patients is a safe and practical approach for coronary angiography or angioplasty, without any major complications. Bearing in mind its high success rate, it can be used when a radial artery is not useful for the catheterization or as a default approach on the expense of slightly longer procedural time.",2020,"The procedure time of coronary angiography and percutaneous coronary intervention of the ulnar group was significantly higher than that of the radial group (P value = 0.011 and 0.034, respectively).","['120 patients was selected randomly for coronary angiography and angioplasty-80 through radial and 40 through ulnar approach', 'coronary procedures as a preliminary experience for operators experienced in trans-radial approach with no/minimal trans-ulnar approach experience at an Egyptian center']","['Percutaneous trans-ulnar versus trans-radial arterial approach for coronary angiography and angioplasty', 'trans-ulnar approach']","['mean caliber of the right ulnar artery', 'local complications and Doppler evaluation', 'Ulnar approach success', 'feasibility and safety', 'procedure time of coronary angiography and percutaneous coronary intervention', 'failure of ulnar artery puncture']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226428', 'cui_str': 'Structure of right ulnar artery'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}]",120.0,0.118131,"The procedure time of coronary angiography and percutaneous coronary intervention of the ulnar group was significantly higher than that of the radial group (P value = 0.011 and 0.034, respectively).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shafiq', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt. shafiqsssd@gmail.com.'}, {'ForeName': 'Hesham Boushra', 'Initials': 'HB', 'LastName': 'Mahmoud', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Malak Lamie', 'Initials': 'ML', 'LastName': 'Fanous', 'Affiliation': 'Cardiology Department, Sohag Heart and GIT Specialized Center, Sohag, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00089-7']
2138,32907547,The effect of midwifery led counseling based on Gamble's approach on childbirth fear and self-efficacy in nulligravida women.,"BACKGROUND


Studies show that childbirth fear is a common problem among Iranian women. Therefore, most Iranian women prefer caesarean section for giving birth. This study investigated the effectiveness of a psychoeducational intervention by midwives (birth emotions - looking to improve expectant fear (BELIEF)) on decreasing childbirth fear and self-efficacy among first-time pregnant women who were afraid of giving birth.
METHODS


A number of 80 pregnant women participated in the study. They had received a score of ≥66 on the Wijma delivery expectancy/experience questionnaire. They were randomly assigned into two groups: intervention (n = 40) and control groups (n = 40). The intervention group received two face-to-face counseling sessions based on the BELEF protocol in the 24th and 34th weeks of pregnancy. Between these two sessions, it also received eight telephone-counseling sessions once a week. The control group only received the prenatal routine care. The outcome measures were childbirth fear, childbirth self-efficacy, and childbirth preference.
RESULTS


The intervention group showed significantly more reduction in childbirth fear and more increase in childbirth self-efficacy compared to the control group. In addition, more women in the intervention group reported that they preferred to give normal vaginal birth than women in the control group.
CONCLUSION


The BELIEF protocol could be an effective approach in reducing childbirth fear and increasing childbirth self-efficacy among first-time pregnant women who are afraid of giving birth.
TRIAL REGISTRATION NUMBER


IRCT20101219005417N3, Date of Registration: 19-12-2018.",2020,The intervention group showed significantly more reduction in childbirth fear and more increase in childbirth self-efficacy compared to the control group.,"['first-time pregnant women who were afraid of giving birth', 'pregnant women who are afraid of giving birth', '80 pregnant women participated in the study', 'nulligravida women', 'Iranian women']","['psychoeducational intervention by midwives (birth emotions - looking to improve expectant fear (BELIEF', 'two face-to-face counseling sessions based on the BELEF protocol', ""midwifery led counseling based on Gamble's approach"", 'prenatal routine care']","['childbirth fear, childbirth self-efficacy, and childbirth preference', 'reduction in childbirth fear', 'childbirth self-efficacy', 'childbirth fear and self-efficacy', 'normal vaginal birth', 'childbirth fear and increasing childbirth self-efficacy']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0232995', 'cui_str': 'Gravida 0'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",80.0,0.0435359,The intervention group showed significantly more reduction in childbirth fear and more increase in childbirth self-efficacy compared to the control group.,"[{'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Firouzan', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Roghieh', 'Initials': 'R', 'LastName': 'Kharaghani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Zenoozian', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Moloodi', 'Affiliation': 'Substance Abuse and Dependence Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Jafari', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran. elhamdjafari@gmail.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03230-1']
2139,32907619,"A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone to treat recurrent pregnancy loss in women with undifferentiated connective tissue diseases: protocol for the Immunosuppressant regimens for LIving FEtuses (ILIFE) trial.","BACKGROUND


Undifferentiated connective tissue disease (UCTD) is known to induce adverse pregnancy outcomes and even recurrent spontaneous abortion (RSA) by placental vascular damage and inflammation activation. Anticoagulation can prevent pregnancy morbidities. However, it is unknown whether the addition of immune suppressants to anticoagulation can prevent spontaneous pregnancy loss in UCTD patients. The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and low-dose prednisone on recurrent pregnancy loss for women with UCTD.
METHODS


The Immunosuppressant for Living Fetuses (ILIFE) Trial is a three-arm, multicenter, open-label randomized controlled trial with the primary objective of comparing hydroxychloroquine combined with low-dose prednisone and anticoagulation with anticoagulation alone in treating UCTD women with recurrent spontaneous abortion. The third arm of using hydroxychloroquine combined with anticoagulant for secondary comparison. A total of 426 eligible patients will be randomly assigned to each of the three arms with a 1:1:1 allocation ratio. The primary outcome is the rate of live births. Secondary outcomes include adverse pregnancy outcomes and progression of UCTD.
DISCUSSION


This is the first multi-center, open-label, randomized controlled trial which evaluates the efficacy of immunosuppressant regimens on pregnancy outcomes and UCTD progression. It will provide evidence on whether the immunosuppressant ameliorates the pregnancy prognosis in UCTD patients with RSA and the progression into defined connective tissue disease.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03671174 . Registered on 14 September 2018.",2020,The Immunosuppressant for Living Fetuses,"['women with undifferentiated connective tissue diseases', 'women with UCTD', 'Living Fetuses', 'LIving FEtuses (ILIFE) trial', '426 eligible patients', 'UCTD patients', 'treating UCTD women with recurrent spontaneous abortion']","['hydroxychloroquine (HCQ) and low-dose prednisone', 'hydroxychloroquine combined with anticoagulant', 'hydroxychloroquine combined with low-dose prednisone and anticoagulation with anticoagulation alone', 'hydroxychloroquine and low-dose prednisone', 'immunosuppressant regimens', 'ILIFE']","['rate of live births', 'pregnancy outcomes and UCTD progression', 'adverse pregnancy outcomes and progression of UCTD', 'recurrent pregnancy loss', 'pregnancy morbidities']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0409999', 'cui_str': 'Undifferentiated connective tissue disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0409999', 'cui_str': 'Undifferentiated connective tissue disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",426.0,0.200771,The Immunosuppressant for Living Fetuses,"[{'ForeName': 'Shaoying', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Ruoning', 'Initials': 'R', 'LastName': 'Ni', 'Affiliation': 'Department of Internal Medicine, Saint Agnes Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Yikang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Suli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact (formerly Clinical Epidemiology and Biostatistics), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China. zhangchunyan_sp@163.com.'}, {'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China. lu_liangjing@163.com.'}]",Trials,['10.1186/s13063-020-04716-1']
2140,32907635,Enoxaparin for primary thromboprophylaxis in ambulatory patients with coronavirus disease-2019 (the OVID study): a structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


The OVID study will demonstrate whether prophylactic-dose enoxaparin improves survival and reduces hospitalizations in symptomatic ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.
TRIAL DESIGN


The OVID study is conducted as a multicentre open-label superiority randomised controlled trial.
PARTICIPANTS


Inclusion Criteria 1. Signed patient informed consent after being fully informed about the study's background. 2. Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment. 3. Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature >37.5° C. 4. Ability of the patient to travel to the study centre by private transportation, performed either by an accompanying person from the same household or by the patient themselves 5. Ability to comply with standard hygiene requirements at the time of in-hospital visit, including a face mask and hand disinfectant. 6. Ability to walk from car to study centre or reach it by wheelchair transport with the help of an accompanying person from the same household also complying with standard hygiene requirements. 7. Ability to self-administer prefilled enoxaparin injections after instructions received at the study centre or availability of a person living with the patient to administer enoxaparin. Exclusion Criteria 1. Any acute or chronic condition posing an indication for anticoagulant treatment, e.g. atrial fibrillation, prior venous thromboembolism (VTE), acute confirmed symptomatic VTE, acute coronary syndrome. 2. Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history, comorbidity or predisposing strong risk factors for thrombosis:  a. Any of the following events occurring in the prior 30 days: fracture of lower limb, hospitalization for heart failure, hip/knee replacement, major trauma, spinal cord injury, stroke,  b. previous VTE,  c. histologically confirmed malignancy, which was diagnosed or treated (surgery, chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or inoperable. 3. Any clinically relevant bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 30 days prior to randomization or sign of acute bleeding. 4. Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute intracranial haemorrhage. 5. Haemoglobin <8 g/dL and platelet count <50 x 10 9  cells/L confirmed by recent laboratory test (<90 days). 6. Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy. 7. Severe renal insufficiency (baseline creatinine clearance <30 mL/min calculated using the Cockcroft-Gault formula) confirmed by recent laboratory test (<90 days). 8. Contraindications to enoxaparin therapy, including prior heparin-induced thrombocytopenia and known hypersensitivity. 9. Current use of dual antiplatelet therapy. 10. Participation in other interventional studies over the past 30 days. 11. Non-compliance or inability to adhere to treatment or lack of a family environment or support system for home treatment. 12. Cognitive impairment and/or inability to understand information provided in the study information. Patient enrolment will take place at seven Swiss centres, including five university hospitals and two large cantonal hospitals.
INTERVENTION AND COMPARATOR


Patients randomized to the intervention group will receive subcutaneous enoxaparin at the recommended dose of 4,000 IU anti-Xa activity (40 mg/0.4 ml) once daily for 14 days. Patients randomized to the comparator group will receive no anticoagulation.
MAIN OUTCOMES


Primary outcome: a composite of any hospitalization or all-cause death occurring within 30 days of randomization.
SECONDARY OUTCOMES


(i) a composite of cardiovascular events, including deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic stroke within 14 days, 30 days, and 90 days of randomization; (ii) each component of the primary efficacy outcome, within 14 days, 30 days, and 90 days of randomization; (iii) net clinical benefit (accounting for the primary efficacy outcome, composite cardiovascular events, and major bleeding), within 14 days, 30 days, and 90 days of enrolment; (iv) primary efficacy outcome, within 14 days, and 90 days of enrolment; (v) disseminated intravascular coagulation (ISTH criteria, in-hospital diagnosis) within 14 days, 30 days, and 90 days of enrolment.
RANDOMISATION


Patients will undergo block stratified randomization (by age: 50-70 vs. >70 years; and by study centre) with a randomization ratio of 1:1 with block sizes varying between 4 and 8. Randomization will be performed after the signature of the informed consent for participation and the verification of the eligibility criteria using the electronic data capture software (REDCAP, Vanderbilt University, v9.1.24).
BLINDING (MASKING)


In this open-label study, no blinding procedures will be used.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The sample size calculation is based on the parameters α = 0.05 (2-sided), power: 1-β = 0.8, event rate in experimental group, pexp = 0.09 and event rate in control group, pcon = 0.15. The resulting total sample size is 920. To account for potential dropouts, the total sample size was fixed to 1000 with 500 patients in the intervention group and 500 in the control group.
TRIAL STATUS


Protocol version 1.0, 14 April 2020. Protocol version 3.0, 18 May 2020 Recruiting start date: June 2020. Last Patient Last Visit: March 2021.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04400799 First Posted: May 26, 2020 Last Update Posted: July 16, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature","['Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment', 'symptomatic ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation', 'ambulatory patients with coronavirus disease-2019 (the OVID study', 'Patients will undergo block stratified randomization (by age: 50-70 vs. >70 years; and by study centre) with a randomization ratio of 1:1 with block sizes varying between 4 and 8', 'Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy', 'Protocol version 1.0, 14 April 2020', '500 patients in the intervention group and 500 in the control group', 'Patient enrolment will take place at seven Swiss centres, including five university hospitals and two large cantonal hospitals']","['enoxaparin injections', 'subcutaneous enoxaparin', 'Enoxaparin', 'enoxaparin', '4,000 IU anti-Xa activity', 'prophylactic-dose enoxaparin', 'comparator group will receive no anticoagulation']","['composite cardiovascular events, and major bleeding', 'Severe renal insufficiency', 'survival and reduces hospitalizations', 'respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature', 'disseminated intravascular coagulation (ISTH criteria, in-hospital diagnosis', 'Intracerebral bleeding', 'fracture of lower limb, hospitalization for heart failure, hip/knee replacement, major trauma, spinal cord injury, stroke, \u2003b', 'composite of any hospitalization or all-cause death occurring within 30 days of randomization', 'deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0340561', 'cui_str': 'Arterial ischemia'}, {'cui': 'C0025474', 'cui_str': 'Mesenteric'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",,0.207643,"Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Bingisser', 'Affiliation': 'Emergency Department, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Service of Haematology, Clinica Luganese Moncucco, Lugano, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Frenk', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Clinic of Haematology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Cardiology Division, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mazzolai', 'Affiliation': 'Department of Angiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Righini', 'Affiliation': 'Division of Angiology and Haemostasis, Department of Medical Specialties, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sebastian', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Spescha', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stortecky', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kucher', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland. nils.kucher@usz.ch.'}]",Trials,['10.1186/s13063-020-04678-4']
2141,32887594,Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) - a feasibility study in patients with knee osteoarthritis using a mixed method approach.,"BACKGROUND


Osteoarthritis is a leading cause of global disability resulting in significant morbidity and cost to the healthcare system. Current guidelines recommend lifestyle changes such exercises and weight loss as first line treatment prior to surgical consideration. Our current model of care is inefficient with suboptimal allied health intervention for effective behaviour changes. A 12-week community based, individualized, multidisciplinary new model of care for knee osteoarthritis was developed in light of current deficiencies.
METHODS


The primary aim of this study was to determine the feasibility of a full randomized controlled trial evaluating this new model of care using pre-defined progression criteria. The secondary aim was to optimize the intervention and study design through a process evaluation. A pilot exploratory, parallel arm, single blinded randomized trial design using a mixed method approach was utilized. Progression criteria for a full trial including key domains of patient recruitment and retention, outcome measure acceptability and improvement, adverse events were developed. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and 12-weeks. Secondary outcomes included quality of life, functional and psychological assessments. Semi-structured interviews were conducted with the patients at 12-weeks.
RESULTS


20 patients (3 males, 17 females) were randomized (10 intervention, 10 control). Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks. Semi-structured interviews revealed several themes pertaining to feasibility and intervention optimization. 5 out of the 6 progression criteria's domains were met (recruitment criteria not met).
CONCLUSION


This pilot has demonstrated the feasibility of a full randomized control trial investigating the potential effectiveness of the new proposed model of care for knee osteoarthritis using pre-defined progression criteria and process evaluation. Results from the qualitative study were used to modify and improve the intervention content, delivery model and study design for a large effectiveness-implementation hybrid randomized control trial that is currently underway.
TRIAL REGISTRATION


Retrospectively registered on 18 January 2019 at http://clinicaltrial.gov ID: NCT03809975 .",2020,"Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks.","['20 patients (3 males, 17 females', 'patients with knee osteoarthritis using a mixed method approach']",[],"['Knee Injury and Osteoarthritis Outcome Score (KOOS', 'quality of life, functional and psychological assessments', 'knee function, quality of life, psychological outcome, dietary improvement and weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],"[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.104048,"Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks.","[{'ForeName': 'Bryan Yijia', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore. btanyj@hotmail.com.'}, {'ForeName': 'Benjamin Tze Keong', 'Initials': 'BTK', 'LastName': 'Ding', 'Affiliation': 'Ministry of Health Holdings, Singapore, Singapore.'}, {'ForeName': 'Michelle Jessica', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Health Services Outcome Research, National Healthcare Group, Singapore, Singapore.'}, {'ForeName': 'Soren Thorgaard', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thumboo', 'Affiliation': 'Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03611-9']
2142,32887873,"Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study.","Prolonging overall survival (OS) remains an unmet need in relapsed or refractory multiple myeloma (RRMM). In ELOQUENT-2 (NCT01239797), elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1-3 prior lines of therapy (LoTs). We report results from the pre-planned final OS analysis after a minimum follow-up of 70.6 months, the longest reported for an antibody-based triplet in RRMM. Overall, 646 patients with RRMM and 1-3 prior LoTs were randomized 1:1 to ERd or Rd. PFS and overall response rate were co-primary endpoints. OS was a key secondary endpoint, with the final analysis planned after 427 deaths. ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68-1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups. No additional safety signals with ERd at extended follow-up were reported. ERd is the first antibody-based triplet regimen shown to significantly prolong OS in patients with RRMM and 1-3 prior LoTs. The magnitude of OS benefit was greatest among patients with adverse prognostic factors, including older age, ISS stage III, IMWG high-risk disease, and 2-3 prior LoTs.",2020,"ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68-1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups.",['646 patients with RRMM and 1-3 prior LoTs'],"['lenalidomide/dexamethasone', 'Elotuzumab, lenalidomide, and dexamethasone', 'elotuzumab plus lenalidomide/dexamethasone (ERd']","['magnitude of OS benefit', 'Prolonging overall survival (OS', 'progression-free survival (PFS', 'PFS and overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1832049', 'cui_str': 'elotuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",646.0,0.116092,"ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68-1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups.","[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens, Greece. mdimop@med.uoa.gr.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital, Nantes, France.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Shpilberg', 'Affiliation': 'Institute of Haematology, Assuta Medical Centers, Tel Aviv, Israel.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Špička', 'Affiliation': 'Charles University in Prague and General Teaching Hospital, Prague, Czech Republic.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Walter-Croneck', 'Affiliation': 'Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Magen', 'Affiliation': 'Department of Hematology Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca-Instituto de Investigación Biomédica de Salamanca, Centro de Investigación del Cáncer-IBMCC (USAL-CSIC), Salamanca, Spain.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Belch', 'Affiliation': 'Cross Cancer Institute and University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reece', 'Affiliation': 'Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Oakervee', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Röllig', 'Affiliation': 'Universitätsklinikum der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Einsele', 'Affiliation': 'Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ying-Ming', 'Initials': 'YM', 'LastName': 'Jou', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ganetsky', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Singhal', 'Affiliation': 'AbbVie Biotherapeutics, Redwood City, CA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Blood cancer journal,['10.1038/s41408-020-00357-4']
2143,32888370,Methotrexate vs secukinumab safety in psoriasis patients with metabolic syndrome.,"The safety of methotrexate in psoriasis patients with metabolic syndrome could be argued because of increased risk of liver toxicity. The aim of the study was to investigate the safety of methotrexate compared with secukinumab in psoriasis patients with metabolic syndrome. A controlled, open trial in psoriasis patients with metabolic syndrome, candidate to methotrexate, or secukinumab. Primary end point of the study was investigating any variations in waist circumference, body mass index, blood pressure, fasting glucose, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, creatinine levels between baseline and month-6 and 12 of follow-up in the two treatment cohorts. A total of 130 (110 male and 20 female) patients were consecutively assigned in a 1:1 ratio to treatment with methotrexate (n = 64) dosed 15 mg weekly or secukinumab (n = 66) at standard dose. At month-6 and month-12 serum levels of liver enzymes were significantly increased only in patients treated with methotrexate (P < .01). Three times elevation of liver enzymes was reported in 4 of 64 patients receiving methotrexate, causing drug withdrawal. No significant changes in other parameters were observed. Methotrexate could induce a liver enzyme increase whereas secukinumab has a neutral effect.",2020,At month-6 and month-12 serum levels of liver enzymes were significantly increased only in patients treated with methotrexate (P < 0.01).,"['64 patients receiving', 'psoriasis patients with metabolic syndrome, candidate to methotrexate or secukinumab', 'A total of 130 (110 male and 20 female) patients', 'psoriasis patients with metabolic syndrome']","['methotrexate', 'methotrexate (n\xa0=\xa064) dosed 15\u2009mg weekly or secukinumab', 'secukinumab', 'Methotrexate']","['serum levels of liver enzymes', 'liver toxicity', 'elevation of liver enzymes', 'waist circumference, body mass index, blood pressure, fasting glucose, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}]",64.0,0.0314493,At month-6 and month-12 serum levels of liver enzymes were significantly increased only in patients treated with methotrexate (P < 0.01).,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gisondi', 'Affiliation': 'Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bellinato', 'Affiliation': 'Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Manfredo', 'Initials': 'M', 'LastName': 'Bruni', 'Affiliation': 'Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'De Angelis', 'Affiliation': 'Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Girolomoni', 'Affiliation': 'Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.'}]",Dermatologic therapy,['10.1111/dth.14281']
2144,32888374,Differential effects of adult attachment in cognitive-behavioural and psychodynamic therapy in social anxiety disorder: A comparison between a self-rating and an observer rating.,"Different measures of attachment are usually weakly correlated. In a subsample of an RCT comparing short-term cognitive-behavioural therapy (CBT) and psychodynamic therapy (PDT), we examined the association between attachment and outcome using two attachment measures. The sample comprises 148 patients with social anxiety disorder who were treated in the SOPHO-NET trial. Pretreatment attachment was assessed using the Adult Attachment Prototype Rating (AAPR) and the Bielefeld Questionnaire of Client Expectations (BQCE). Regression models were used to predict the therapeutic alliance (HAQ) at session 8, the Liebowitz Social Anxiety Scale (LSAS) at the end of therapy and a 6-month follow-up. Attachment groups (secure, avoidant, and ambivalent) classified with the AAPR and the BQCE were not significantly correlated (Cohen's κ = 0.08). Only the BQCE was associated with the HAQ indicating avoidantly attached patients showing lower HAQ scores than securely attached (Cohen's d = 0.722). Regarding the AAPR, we found an interaction effect of treatment and attachment related to the post-treatment LSAS scores. Post hoc tests revealed that securely attached patients in CBT had lower scores than securely attached in PDT (d = 0.922) and, on a trend level, avoidantly attached in CBT (d = 0.782). We conclude that attachment-outcome associations are affected by the applied measure. The identified differential effects suggest that psychotherapists should adapt the interventions on the attachment of their patients.",2020,Only the BQCE was associated with the HAQ indicating avoidantly attached patients showing lower HAQ scores than securely attached (Cohen's d=0.722).,"['148 patients with social anxiety disorder who were treated in the SOPHO-NET trial', 'social anxiety disorder']","['RCT comparing short-term cognitive-behavioral therapy (CBT) and psychodynamic therapy (PDT', 'cognitive-behavioral and psychodynamic therapy']","['Liebowitz Social Anxiety Scale (LSAS', 'HAQ scores', 'Adult Attachment Prototype Rating (AAPR) and the Bielefeld Questionnaire of Client Expectations (BQCE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",148.0,0.0100143,Only the BQCE was associated with the HAQ indicating avoidantly attached patients showing lower HAQ scores than securely attached (Cohen's d=0.722).,"[{'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Altmann', 'Affiliation': 'Institute of Psychosocial Medicine, Psychotherapy and Psycho-Oncology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Nodop', 'Affiliation': 'Institute of Psychosocial Medicine, Psychotherapy and Psycho-Oncology, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Dinger', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Ehrenthal', 'Affiliation': 'Institute of Medical Psychology, University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Schauenburg', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Wibke', 'Initials': 'W', 'LastName': 'Dymel', 'Affiliation': 'Private Practice, Essen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Willutzki', 'Affiliation': 'Department of Psychology and Psychotherapy, University of Witten-Herdecke, Witten-Herdecke, Germany.'}, {'ForeName': 'Bernhard M', 'Initials': 'BM', 'LastName': 'Strauss', 'Affiliation': 'Institute of Psychosocial Medicine, Psychotherapy and Psycho-Oncology, Jena University Hospital, Jena, Germany.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2513']
2145,32888452,"Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


Venetoclax plus obinutuzumab has been established as a fixed-duration treatment regimen for patients with chronic lymphocytic leukaemia. We compared the long-term efficacy after treatment cessation of the combination of venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab in patients with previously untreated chronic lymphocytic leukaemia.
METHODS


CLL14 is a multicentre, randomised, open-label, phase 3 trial done at 196 sites in 21 countries. Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30-69 mL/min, or both. Patients were randomly assigned (1:1) via a web and voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region. Patients received either venetoclax plus obinutuzumab (oral venetoclax initiated on day 22 of cycle 1 [28-day cycles], with a 5-week dose ramp-up [20 mg, 50 mg, 100 mg, and 200 mg, then 400 mg daily for 1 week], thereafter continuing at 400 mg daily until completion of cycle 12; combined with intravenous obinutuzumab for six cycles starting with 100 mg on day 1 and 900 mg on day 2 [or 1000 mg on day 1], 1000 mg on days 8 and day 15 of cycle 1, and subsequently 1000 mg on day 1 of cycles 2 through 6) or chlorambucil plus obinutuzumab (oral chlorambucil at 0·5 mg/kg bodyweight on days 1 and 15 of each cycle for 12 cycles combined with the same obinutuzumab regimen). The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. Patient enrolment is complete, and the study is registered with ClinicalTrails.gov, NCT02242942.
FINDINGS


Between Aug 7, 2015, and Aug 4, 2016, 432 patients were enrolled and randomly assigned to receive either venetoclax plus obinutuzumab (n=216) or chlorambucil plus obinutuzumab (n=216). All patients had been off treatment for at least 24 months at data collection. At a median follow-up of 39·6 months (IQR 36·8-43·0), patients given venetoclax plus obinutuzumab had a significantly longer progression-free survival than did patients given chlorambucil plus obinutuzumab (HR 0·31, 95% CI 0·22-0·44; p<0·0001). Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group. The most common grade 3 or 4 adverse event in both groups was neutropenia (112 [53%] of 212 patients in the venetoclax plus obinutuzumab group versus 102 [48%] of 214 patients in the chlorambucil plus obinutuzumab group). Serious adverse events occurred in 115 (54%) of 212 patients in the venetoclax plus obinutuzumab group and 95 (44%) of 214 patients in the chlorambucil plus obinutuzumab group. Venetoclax or chlorambucil treatment-related deaths were reported in one (1%) of 212 patients in the venetoclax plus obinutuzumab group (n=1 sepsis) and two (1%) of 214 patients in the chlorambucil plus obinutuzumab group (n=1 septic shock, n=1 metastatic skin squamous carcinoma).
INTERPRETATION


2 years after treatment cessation, venetoclax plus obinutuzumab continues to significantly improve progression-survival compared with chlorambucil plus obinutuzumab, thereby providing a limited duration treatment option for patients with previously untreated chronic lymphocytic leukaemia.
FUNDING


F Hoffmann-La Roche and AbbVie.",2020,Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group.,"['previously untreated chronic lymphocytic leukaemia (CLL14', 'patients with previously untreated chronic lymphocytic leukaemia', 'Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30-69 mL/min, or both', 'patients with chronic lymphocytic leukaemia', '196 sites in 21 countries', 'Between Aug 7, 2015, and Aug 4, 2016, 432 patients', '212 patients in the venetoclax plus obinutuzumab group (n=1 sepsis) and two (1%) of 214 patients in the chlorambucil plus obinutuzumab group (n=1 septic shock, n=1 metastatic skin squamous carcinoma']","['venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab', 'venetoclax plus obinutuzumab (oral venetoclax', 'Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab', 'chlorambucil plus obinutuzumab', 'intravenous obinutuzumab', 'Venetoclax or chlorambucil', 'venetoclax plus obinutuzumab', 'chlorambucil plus obinutuzumab (oral chlorambucil', 'voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region']","['Safety', 'longer progression-free survival', 'Serious adverse events', 'investigator-assessed progression-free survival', 'neutropenia', 'progression-survival', 'Median progression-free survival']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",432.0,0.282151,Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group.,"[{'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Tandon', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoylova', 'Affiliation': 'Regional Clinical Hospital NA Semashko, Nizhny Novgorod, Russia.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Division of Onco-Hematology, Santa Maria Terni Hospital, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pinilla-Ibarz', 'Affiliation': 'Department of Malignant Hematology, H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Opat', 'Affiliation': 'Haematology Department, School of Clinical Sciences at Monash Health, Monash University, VIC, Australia.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Sivcheva', 'Affiliation': 'First Internal Department, MHAT Hristo Botev, AD, Vratsa, Bulgaria.'}, {'ForeName': 'Katell', 'Initials': 'K', 'LastName': 'Le Dû', 'Affiliation': 'Hematology Department, Clinique Le Mans, France.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Fogliatto', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carsten U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weinkove', 'Affiliation': 'Wellington Blood and Cancer Centre, Capital and Coast District Health Board and Malaghan Institute of Medical Research, Wellington, New Zealand.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Queen Elizabeth II Health Science Center, Halifax, NS, Canada.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'Moores Cancer Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department III of Internal Medicine, Ulm University, Ulm, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Schary', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ritgen', 'Affiliation': 'Department II of Internal Medicine, Campus Kiel, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department III of Internal Medicine, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany. Electronic address: michael.hallek@uk-koeln.de.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30443-5']
2146,32889444,Evaluating substance use treatment efficacy for younger and older adults.,"The purpose of this study was to examine the differential efficacy of aftercare substance use treatments for younger (below 40, n = 107) versus older (40+, n = 114) adults (N = 221), using data from a randomized controlled trial in a community-based substance abuse treatment center. The younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1. Primary outcomes were rates of abstinence and percent use days at 1-year follow-up. Outcomes were compared between standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU). Results showed significant differences by treatment in the older, but not in younger, subsample of participants. Specifically, the older participants in MBRP had significantly higher abstinence rates compared with those in TAU. Further, the older individuals in MBRP had a significantly lower percent of days on which they used compared with those in TAU and RP. Overall, findings suggest that age group may impact aftercare treatment substance use outcomes.",2020,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","['younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1', 'younger (below 40, n\xa0=\xa0107) versus older (40+, n\xa0=\xa0114) adults (N\xa0=\xa0221), using data from a randomized controlled trial in a community-based substance abuse treatment center', 'younger and older adults']",['aftercare substance'],"['rates of abstinence and percent use days at 1-year follow-up', 'abstinence rates', 'standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079256', 'cui_str': 'Substance abuse treatment center'}]","[{'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",114.0,0.101879,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","[{'ForeName': 'Tyree', 'Initials': 'T', 'LastName': 'Dingle', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States. Electronic address: ding7624@pacificu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106618']
2147,32889451,Episodic future thinking reduces chronic pain severity: A proof of concept study.,"BACKGROUND


Chronic pain is a major public health challenge in the United States and around the world. Current treatments including opioid analgesics and cognitive behavioral therapy possess harmful side effects or limited efficacy, respectively. Chronic pain is associated with a variety of unhealthy behaviors including opioid misuse. Moreover, individuals who suffer from chronic pain exhibit excessive discounting of delayed rewards, suggesting a constricted temporal window of valuation. Reductions in the excessive discounting of delayed rewards has been achieved with Episodic Future Thinking (EFT; vividly imagining realistic future events). EFT has also been associated with reductions in a variety of unhealthy behaviors. In this study, the effects of EFT on delay discounting and levels of pain were investigated in individuals reporting chronic pain.
METHODS


Individuals reporting chronic pain (N = 250; 42.4 % female) were recruited through the Amazon Mechanical Turk platform. Measures of delay discounting and pain were collected at baseline and again after randomization to EFT (N = 128) or Control Episodic Thinking (CET) (N = 122).
RESULTS


EFT significantly reduced delay discounting relative to baseline (p < 0.001) and EFT reduced pain scores in a baseline dependent manner (p = 0.001) when compared to CET; that is, those with the greatest reports of pain experienced the greatest reduction. Furthermore the reduction in delay discounting fully mediated the reduction in pain.
CONCLUSIONS


These findings suggest that Episodic Future Thinking, by widening the temporal window, may reduce pain in those reporting chronic pain and therefore represents a potential novel therapeutic.",2020,"RESULTS


EFT significantly reduced delay discounting relative to baseline (p < 0.001) and EFT reduced pain scores in a baseline dependent manner (p = 0.001) when compared to CET; that is, those with the greatest reports of pain experienced the greatest reduction.","['individuals reporting chronic pain', 'Individuals reporting chronic pain (N = 250; 42.4 % female']","['EFT', 'Control Episodic Thinking (CET', 'Episodic future thinking', 'opioid analgesics and cognitive behavioral therapy']","['EFT reduced pain scores', 'Chronic pain', 'delay discounting and levels of pain', 'delay discounting and pain', 'chronic pain severity', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.120371,"RESULTS


EFT significantly reduced delay discounting relative to baseline (p < 0.001) and EFT reduced pain scores in a baseline dependent manner (p = 0.001) when compared to CET; that is, those with the greatest reports of pain experienced the greatest reduction.","[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Craft', 'Affiliation': 'Center for Transformative Research on Health Behaviors, 1 Riverside Circle, Roanoke, VA 24016, United States; Graduate Program in Translational Biology, Medicine, and Health, Virginia Tech, 1 Riverside Circle, Roanoke, VA 24016, United States; Fralin Biomedical Research Institute at VTC, 2 Riverside Circle, Roanoke, VA 24016, United States.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Tegge', 'Affiliation': 'Center for Transformative Research on Health Behaviors, 1 Riverside Circle, Roanoke, VA 24016, United States; Department of Statistics, Virginia Tech, Blacksburg, VA 24061, United States.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Center for Transformative Research on Health Behaviors, 1 Riverside Circle, Roanoke, VA 24016, United States; Fralin Biomedical Research Institute at VTC, 2 Riverside Circle, Roanoke, VA 24016, United States. Electronic address: wkbickel@vtc.vt.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108250']
2148,32889494,"The closer you feel, the more you care: Positive associations between closeness, pain intensity rating, empathic concern and personal distress to someone in pain.","Previous research revealed inconsistent findings regarding affective responses when facing someone in pain (i.e., empathic concern and/or personal distress). In this paper, we suggest that the degree of closeness between the observer and the person in pain may account for these contradictory results, such that greater closeness towards this person leads to higher personal distress. To test this hypothesis, we induced either low or high closeness with a confederate in 69 randomly assigned participants. Following the closeness induction, participants evaluated their affective responses (empathic concern and personal distress) and rated the confederate's pain intensity after watching the confederate undergoing a painful cold pressure task. Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress. This study thus suggests that closeness is associated with higher cognitive and affective responses to a person in pain.",2020,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.",['69 randomly assigned participants'],['confederate undergoing a painful cold pressure task'],"[""affective responses (empathic concern and personal distress) and rated the confederate's pain intensity"", 'pain intensity rating, empathic concern and personal distress to someone in pain', 'pain intensity rating, empathic concern and personal distress']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",69.0,0.0551593,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Grynberg', 'Affiliation': 'Univ. Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, F-59000 Lille, France; Institut Universitaire de France, Paris, France. Electronic address: Delphine.Grynberg@univ-lille.fr.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Konrath', 'Affiliation': 'Lilly Family School of Philanthropy, Indiana University, Indianapolis, IN 46202, United States of America.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103175']
2149,32891115,Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial.,"BACKGROUND


The cross-sectional area of the subclavian vein (csSCV) is a crucial factor in the successful catheterization of the subclavian vein. This randomized controlled study investigated the effects of the csSCV on landmark-based subclavian vein catheterization.
METHODS


This study was performed using a two-stage protocol. During stage I, the csSCV was measured in 17 patients placed in the supine, 20° ipsilateral tilt, and 20° contralateral tilt positions in a random order. During stage II, landmark-based subclavian vein catheterization was randomly performed in patients placed in either the supine (group S, n = 107) or the ipsilateral tilt (group I, n = 109) position. The primary outcome measure was the csSCV in stage I and the primary venipuncture success rate in stage II. Secondary outcome measures were the time to successful venipuncture, the total catheterization time, the first-pass success rate, and the incidence of mechanical complications during catheterization.
RESULTS


The csSCV was significantly larger in the ipsilateral tilt than in either the supine or contralateral tilt position (1.01 ± 0.35 vs. 0.84 ± 0.32 and 0.51 ± 0.26 cm 2 , P = .006 and < .001, respectively). The primary venipuncture success rate did not differ significantly between the group S and I (57.0 vs. 64.2%, P = .344). There were also no significant differences in the secondary outcome measures of the two groups.
CONCLUSIONS


The csSCV was significantly larger in patients placed in the ipsilateral tilt than in the supine position, but the difference did not result in better clinical performance of landmark-based subclavian vein catheterization.
TRIAL REGISTRATION


NCT03296735 for stage I ( ClinicalTrials.gov , September 28, 2017) and NCT03303274 for stage II ( ClinicalTrials.gov , October 6, 2017).",2020,"The csSCV was significantly larger in the ipsilateral tilt than in either the supine or contralateral tilt position (1.01 ± 0.35 vs. 0.84 ± 0.32 and 0.51 ± 0.26 cm 2 , P = .006 and < .001, respectively).",[],"['csSCV', 'subclavian vein (csSCV', 'subclavian vein catheterization', 'ipsilateral tilt', 'landmark-based subclavian vein catheterization', 'ipsilateral tilt position']","['clinical performance of landmark-based subclavian vein catheterization', 'time to successful venipuncture, the total catheterization time, the first-pass success rate, and the incidence of mechanical complications during catheterization', 'csSCV in stage', 'primary venipuncture success rate']",[],"[{'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C1319106', 'cui_str': 'Catheterization of subclavian vein'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319106', 'cui_str': 'Catheterization of subclavian vein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.121587,"The csSCV was significantly larger in the ipsilateral tilt than in either the supine or contralateral tilt position (1.01 ± 0.35 vs. 0.84 ± 0.32 and 0.51 ± 0.26 cm 2 , P = .006 and < .001, respectively).","[{'ForeName': 'Hyun-Kyu', 'Initials': 'HK', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Pyoyoon', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jung-Man', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hee-Pyoung', 'Initials': 'HP', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Youn Joung', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea. mingming7@gmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01144-1']
2150,32891126,A virtual clinic for the management of diabetes-type 1: study protocol for a randomised wait-list controlled clinical trial.,"BACKGROUND


Diabetes is a serious chronic disease. Medical treatment and good psychosocial support are needed to cope with acute and long-term effects of diabetes. Self-management is a large part of diabetes management, with healthcare providers playing a supportive role. Young adults with type 1 diabetes are of special interest as they tend to have higher mean glycosylated haemoglobin values than other patients with type 1 diabetes, and they often miss visits in traditional diabetes care. A well-designed virtual solution may improve a range of measures (e.g. glycaemic control and perceived health) and reduce hospitalisations.
METHOD


This randomised controlled trial with a control group using a wait list design will recruit 100 young adults from a hospital in Sweden. All participants will receive usual diabetes care besides the virtual clinic. The primary objective is to evaluate the effect of a virtual diabetes clinic on glycaemic control, treatment satisfaction and quality of life in young adults (aged 18-25 years) with type-1 diabetes. The secondary objective is to determine the effects of virtual care on the patient experience.
DISCUSSION


Virtual tools are becoming increasingly common in healthcare; however, it remains unclear if these tools improve diabetes self-management. The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management.
TRIAL REGISTRATION


Current controlled trials: ISRCTN, number: 73435627, registered 23 October 2019. https://doi.org/10.1186/ISRCTN73435627.",2020,"The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management.
","['100 young adults from a hospital in Sweden', 'Young adults with type 1 diabetes', 'young adults (aged 18-25\u2009years) with type-1 diabetes', 'number: 73435627, registered 23 October 2019']",['virtual diabetes clinic'],"['glycaemic control, treatment satisfaction and quality of life']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",100.0,0.0803413,"The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management.
","[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Nerpin', 'Affiliation': 'Department of Medical Sciences, Respiratory Medicine, Allergy and Sleep, Uppsala University, Uppsala, Sweden. ene@du.se.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Toft', 'Affiliation': 'Department of Medicine, Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fischier', 'Affiliation': 'Diabetes Unit, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lindholm-Olinder', 'Affiliation': 'Department of Medical Sciences, Clinical Diabetology and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Janeth', 'Initials': 'J', 'LastName': 'Leksell', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, SE-791 88, Falun, Sweden.'}]",BMC endocrine disorders,['10.1186/s12902-020-00615-3']
2151,32891136,Efficacy of different dose of dexmedetomidine combined with remifentanil in colonoscopy: a randomized controlled trial.,"BACKGROUND


Dexmedetomidine has advantages during colonoscopy as it allows the patient to cooperate during the procedure. Few studies examined the dexmedetomidine-remifentanil combination. This study was to evaluate the effects of different doses of the dexmedetomidine-remifentanil combination in colonoscopy.
METHODS


This was a prospective trial carried out at the Fourth Hospital of Hebei Medical University between 02/2018 and 10/2018. The patients were randomized: group I (dexmedetomidine 0.2 μg·kg - 1 ), group II (dexmedetomidine 0.3 μg·kg - 1 ), and group III (dexmedetomidine 0.4 μg·kg - 1 ), all combined with remifentanil. The primary outcomes were the patient's body movements during the procedure and adverse events.
RESULTS


Compared with at admission (T 0 ), the SBP, HR, and RR at immediately after giving DEX (T 1 ), at the beginning of the examination (T 2 ), 5 min after the beginning of the examination (T 3 ), 10 min after the beginning of the examination (T 4 ), and at the end of the examination (T 5 ) in the three groups were all reduced (all P < 0.05), but all were within the clinically normal range. SpO 2  remained > 98% in all patients during the examination. Compared with T 0 , the BIS values of the three groups were decreased at T 1  and T 2  (all P < 0.05). There were no significant differences in BIS among the three groups (all P > 0.05). The minimum BIS value in group III was lower than in groups I and II (P < 0.05). The degree of satisfaction with the anesthesia effect was higher in groups II and III that in group I (P < 0.05). No hypotension occurred, seven patients had bradycardia, and four patients had nausea/vomiting.
CONCLUSIONS


Dexmedetomidine 0.3 μg·kg - 1  combined with remifentanil was effective for colonoscopy and had few adverse reactions. Chinese Clinical Trial Registry: ChiCTR2000029105 , Registered 13 January 2020 - Retrospectively registered.",2020,The degree of satisfaction with the anesthesia effect was higher in groups II and III that in group I (P < 0.05).,"['Registered 13 January 2020 - Retrospectively registered', 'colonoscopy', 'Fourth Hospital of Hebei Medical University between 02/2018 and 10/2018']","['dexmedetomidine 0.2\u2009μg·kg -\u20091 ), group II (dexmedetomidine 0.3\u2009μg·kg -\u20091 ), and group III', 'dexmedetomidine 0.4\u2009μg·kg -\u20091 ), all combined with remifentanil', 'Dexmedetomidine', 'remifentanil', 'dexmedetomidine-remifentanil', 'dexmedetomidine combined with remifentanil']","['BIS values', 'hypotension', 'degree of satisfaction with the anesthesia effect', 'BIS', 'minimum BIS value', 'SBP, HR, and RR', 'nausea/vomiting', ""patient's body movements during the procedure and adverse events""]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0661239,The degree of satisfaction with the anesthesia effect was higher in groups II and III that in group I (P < 0.05).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Tong', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China. 281575038@qq.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01141-4']
2152,32891139,Vitamin D supplementation in obese Sri Lankan children: a randomized controlled trial.,"BACKGROUND


Micronutrient deficiencies are identified among obese individuals. Vitamin D deficiency (VDD) is prevalent in obese children, and is hypothesized to cause insulin resistance and metabolic abnormalities. This study aimed to determine the effect of vitamin D supplementation on obesity and related metabolic abnormalities among obese Sri Lankan children with VDD.
METHODS


A triple-blind randomized controlled trial was conducted among vitamin D deficient (< 20 ng/ml), obese children (n = 96), randomly allocated to three intervention arms - treatment arm receiving weekly vitamin D 2  50,000 IU; supplementation arm receiving 2500 IU weekly and control arm, receiving placebo. Anthropometry, percentage fat mass (%FM) and blood pressure were assessed and fasting blood glucose, fasting insulin, lipid profile, aspartate transaminase (ALT), alanine transaminase (AST), vitamin D, parathyroid hormone (PTH) and hs-CRP and OGTT with 2-h random blood glucose and insulin was performed at baseline and after 24 weeks of treatment. Ethics Review Committee of Faculty of Medicine, University of Colombo approved the protocol.
RESULTS


Waist circumference Z-score, %FM and serum calcium significantly improved across all three arms, ALT significantly improved in treatment and supplementation arms while, BMI Z-score, PTH and vitamin D significantly improved in the treatment arm. Biceps (p = 0.035) and subscapular (0.048) skin fold thickness, vitamin D (p = 0.004) and ALT (p = 0.012) significantly improved in the treatment arm.
CONCLUSIONS


A strict dietary and physical activity regimen could improve some of the anthropometric, body composition and metabolic profiles, but high dose vitamin D, enhances those improvements. Therefore high dose vitamin D seems to potentiate management outcomes of obese children with vitamin D deficiency.
TRIAL REGISTRATION


The study was registered at the Sri Lanka Clinical Trials Registry (SLCTR/2015/017) on 12th September 2015 at https://slctr.lk/trials/slctr-2015-017 .",2020,"Biceps (p = 0.035) and subscapular (0.048) skin fold thickness, vitamin D (p = 0.004) and ALT (p = 0.012) significantly improved in the treatment arm.
","['obese individuals', 'obese Sri Lankan children', 'obese children with vitamin D deficiency', '\u200920\u2009ng/ml), obese children (n\u2009=\u200996', 'obese Sri Lankan children with VDD', 'obese children']","['vitamin D supplementation', 'vitamin D', 'Vitamin D deficiency (VDD', 'Vitamin D supplementation', 'vitamin D deficient', 'vitamin D 2  50,000\u2009IU; supplementation arm receiving 2500\u2009IU weekly and control arm, receiving placebo']","['Anthropometry, percentage fat mass (%FM) and blood pressure were assessed and fasting blood glucose, fasting insulin, lipid profile, aspartate transaminase (ALT), alanine transaminase (AST), vitamin D, parathyroid hormone (PTH) and hs-CRP and OGTT with 2-h random blood glucose and insulin', 'BMI Z-score, PTH and vitamin D', 'subscapular (0.048) skin fold thickness, vitamin D', 'Waist circumference Z-score, %FM and serum calcium', 'obesity and related metabolic abnormalities']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0428567', 'cui_str': 'Random blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0424680', 'cui_str': 'Skin-fold thickness'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.582768,"Biceps (p = 0.035) and subscapular (0.048) skin fold thickness, vitamin D (p = 0.004) and ALT (p = 0.012) significantly improved in the treatment arm.
","[{'ForeName': 'D B D L', 'Initials': 'DBDL', 'LastName': 'Samaranayake', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'S G S', 'Initials': 'SGS', 'LastName': 'Adikaram', 'Affiliation': 'Colombo South Teaching Hospital, Kalubowila, Sri Lanka.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Atapattu', 'Affiliation': 'Lady Ridgeway Hospital, Colombo, Sri Lanka.'}, {'ForeName': 'K M D L D', 'Initials': 'KMDLD', 'LastName': 'Kendaragama', 'Affiliation': 'Lady Ridgeway Hospital, Colombo, Sri Lanka.'}, {'ForeName': 'J T N', 'Initials': 'JTN', 'LastName': 'Senevirathne', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Jayasekera', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Wickramasinghe', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. pujithaw@yahoo.com.'}]",BMC pediatrics,['10.1186/s12887-020-02329-w']
2153,32891140,"The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes.","BACKGROUND


Previous studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes' health outcomes is needed. Therefore, the aim of this exploratory study is to examine the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on glycemic control, DSCB, and fatigue.
METHODS


Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center, were randomly assigned to CBT-I (n = 14) or Health Education (HE; n = 14). The CBT-I and HE groups received 6 weekly one-hour sessions. This Randomized Controlled Trial (RCT) used a non-inferiority framework to test the effectiveness of CBT-I. Validated assessments were administered at baseline and post-intervention to assess glycemic control, DSCB, and fatigue. A Wilcoxon signed-rank test was utilized to compare within-group changes from baseline to post-intervention. A Mann-Whitney test was utilized to measure the between-group differences. Linear regression was used to assess the association between the blood glucose level and the number of days in the CBT-I group.
RESULTS


The recruitment duration was from October 2018 to May 2019. A total of 13 participants completed the interventions in each group and are included in the final analysis. No adverse events, because of being a part of this RCT, were reported. CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue. There was a significant association between the number of days in the CBT-I intervention with the blood glucose level before bedtime (B = -0.56, p = .009) and after awakening in the morning (B = -0.57, p = .007).
CONCLUSIONS


This study demonstrated a clinically meaningful effect of CBT-I on glycemic control in people with T2D and insomnia symptoms. Also, CBT-I positively impacted daytime functioning, including DSCB and fatigue. Future research is needed to investigate the long-term effects of CBT-I on laboratory tests of glycemic control and to understand the underlying mechanisms of any improvements.
TRIAL REGISTRATION


Clinical Trials Registry ( NCT03713996 ). Retrospectively registered on 22 October 2018.",2020,"CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue.","[""individuals with T2D and insomnia symptoms on diabetes' health outcomes"", 'Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center', 'people with T2D and insomnia symptoms', '13 participants completed the interventions in each group and are included in the final analysis', 'People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB', 'people with type 2 diabetes (T2D', 'people with type 2 diabetes mellitus']","['CBT-I', 'Cognitive Behavioral Therapy', 'cognitive behavioral therapy']","['glycemic control, DSCB, and fatigue', 'daytime functioning, including DSCB and fatigue', 'blood glucose level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",28.0,0.0734898,"CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue.","[{'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Alshehri', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA. phdalshehri@gmail.com.'}, {'ForeName': 'Shaima A', 'Initials': 'SA', 'LastName': 'Alothman', 'Affiliation': 'Lifestyle and Health Research Center, Princess Nora bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Aqeel M', 'Initials': 'AM', 'LastName': 'Alenazi', 'Affiliation': 'Physical Therapy Department, Prince Sattam Bin Abdulaziz University, Alkharj, Central Region, Saudi Arabia. aqeelalenazi.pt@gmail.com.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Rucker', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA.'}, {'ForeName': 'Milind A', 'Initials': 'MA', 'LastName': 'Phadnis', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miles', 'Affiliation': 'Endocrinology Department, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kluding', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA.'}]",BMC endocrine disorders,['10.1186/s12902-020-00612-6']
2154,32891163,Growth hormone alleviates oxidative stress and improves the IVF outcomes of poor ovarian responders: a randomized controlled trial.,"BACKGROUND


Oxidative stress (OS), defined as an imbalance between excessive reactive oxygen species (ROS) and/or reactive nitrogen species (RNS) production and antioxidant insufficiency, has been suggested to be involved in the pathogenesis of poor ovarian response (POR). Growth hormone (GH) can reduce OS in some cell types. This study investigated whether GH can improve OS and the in vitro fertilization and embryo transfer (IVF-ET) outcomes of poor ovarian responders.
METHODS


This study enrolled 105 patients with POR and 58 patients without POR (controls) who were diagnosed according to the Bologna criteria and underwent conventional IVF-ET. Poor ovarian responders were randomly assigned to two groups: the POR-GH group, which received pretreatment with GH 4 IU/d on day 2 of the previous menstrual cycle before IVF until the trigger day, and the POR-C group, which received no pretreatment. OS markers in follicular fluid (FF), ROS levels in granulosa cells (GCs), and the IVF outcomes of the groups were compared.
RESULTS


Endometrial thickness on trigger day, the number of cleaved embryos, the number of higher-quality embryos, and the rates of embryo formation, higher-quality embryo formation, implantation and clinical pregnancy were significantly increased in the POR-GH group compared with the POR-C group (P < 0.05). Moreover, compared to those in the non-POR group, FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs were significantly higher, whereas superoxide dismutase (SOD) and the total antioxidant capacity (TAC) were significantly lower in the POR-C group (P < 0.05). Furthermore, compared with those in the POR-C group, the FF TAC was significantly increased in the POR-GH group, and TOS, OSI and intracellular ROS levels were significantly reduced (P < 0.05).
CONCLUSIONS


Pretreatment with GH alleviates OS and improves oocyte quality and IVF outcomes of poor ovarian responders.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. ChiCTR1900021269 . Registered 8 February 2019, http://www.chictr.org.cn/edit.aspx?pid=35837&htm=4 .",2020,"Moreover, compared to those in the non-POR group, FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs were significantly higher, whereas superoxide dismutase (SOD) and the total antioxidant capacity (TAC) were significantly lower in the POR-C group (P < 0.05).","['poor ovarian responders', 'Poor ovarian responders', '105 patients with POR and 58 patients without POR (controls) who were diagnosed according to the Bologna criteria and underwent conventional IVF-ET']","['Growth hormone', 'GH alleviates OS', 'Growth hormone (GH', 'GH', 'POR-GH']","['number of cleaved embryos, the number of higher-quality embryos', 'rates of embryo formation, higher-quality embryo formation, implantation and clinical pregnancy', 'OS markers in follicular fluid (FF), ROS levels in granulosa cells (GCs), and the IVF outcomes', 'FF TAC', 'oocyte quality and IVF outcomes', 'FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs', 'IVF outcomes', 'superoxide dismutase (SOD) and the total antioxidant capacity (TAC', 'TOS, OSI and intracellular ROS levels']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",105.0,0.0640384,"Moreover, compared to those in the non-POR group, FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs were significantly higher, whereas superoxide dismutase (SOD) and the total antioxidant capacity (TAC) were significantly lower in the POR-C group (P < 0.05).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""Reproductive Medicine Centre, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, #290 Shayan West Second Street, Wuhou District, Chengdu, Sichuan, People's Republic of China. gongyan0619@163.com.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Genetics, School of Bioscience and Technology, Chengdu Medical College, #783 Xindu Avenue, Xindu District, Chengdu, Sichuan, 610500, People's Republic of China. zhangkunyyo@163.com.""}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Xiong', 'Affiliation': ""Reproductive Medicine Centre, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, #290 Shayan West Second Street, Wuhou District, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Jiajing', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Reproductive Medicine Centre, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, #290 Shayan West Second Street, Wuhou District, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': ""Department of Genetics, School of Bioscience and Technology, Chengdu Medical College, #783 Xindu Avenue, Xindu District, Chengdu, Sichuan, 610500, People's Republic of China.""}, {'ForeName': 'Shengfang', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""Department of Medical Genetics and Prenatal Diagnosis, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, Chengdu, Sichuan, People's Republic of China.""}]",Reproductive biology and endocrinology : RB&E,['10.1186/s12958-020-00648-2']
2155,32909497,Spironolactone in Atrial Fibrillation With Preserved Cardiac Fraction: The IMPRESS-AF Trial.,"Background Patients with permanent atrial fibrillation have poor outcomes, exercise capacity, and quality of life even on optimal anticoagulation. Based on mechanistic and observational data, we tested whether the mineralocorticoid receptor antagonist spironolactone can improve exercise capacity, E/e' ratio, and quality of life in patients with permanent atrial fibrillation and preserved ejection fraction. Methods and Results The double-masked, placebo-controlled IMPRESS-AF (Improved Exercise Tolerance in Heart Failure With Preserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation) trial (NCT02673463) randomized 250 stable patients with permanent atrial fibrillation and preserved left ventricular ejection fraction to spironolactone 25 mg daily or placebo. Patients were followed for 2 years. The primary efficacy outcome was peak oxygen consumption on cardiopulmonary exercise testing at 2 years. Secondary end points included 6-minute walk distance, E/e' ratio, quality of life, and hospital admissions. Spironolactone therapy did not improve peak oxygen consumption at 2 years (14.0 mL/min per kg [SD, 5.4]) compared with placebo (14.5 [5.1], adjusted treatment effect, -0.28; 95% CI, -1.27 to 0.71];  P =0.58). The findings were consistent across all sensitivity analyses. There were no differences in the 6-minute walking distance (adjusted treatment effect, -8.47 m; -31.9 to 14.9;  P =0.48), E/e' ratio (adjusted treatment effect, -0.68; -1.52 to 0.17,  P =0.12), or quality of life ( P =0.74 for EuroQol-5 Dimensions, 5-level version quality of life questionnaire and  P =0.84 for Minnesota Living with Heart Failure). At least 1 hospitalization occurred in 15% of patients in the spironolactone group and 23% in the placebo group ( P =0.15). Estimated glomerular filtration rate was reduced by 6 mL/min in the spironolactone group with <1-unit reduction in controls ( P <0.001). Systolic blood pressure was reduced by 7.2 mm Hg (95% CI, 2.2-12.3) in the spironolactone group versus placebo ( P =0.005). Conclusions Spironolactone therapy does not improve exercise capacity, E/e' ratio, or quality of life in patients with chronic atrial fibrillation and preserved ejection fraction. Registration UTL: https://www.clini​caltr​ial.gov; Unique identifier: NCT02673463. EudraCT number 2014-003702-33.",2020,"Systolic blood pressure was reduced by 7.2 mm Hg (95% CI, 2.2-12.3) in the spironolactone group versus placebo ( P =0.005).","['patients with chronic atrial fibrillation and preserved ejection fraction', 'Heart Failure', ' Patients with permanent atrial fibrillation', 'patients with permanent atrial fibrillation and preserved ejection fraction', 'Atrial Fibrillation With Preserved Cardiac Fraction', '250 stable patients with permanent atrial fibrillation and preserved left ventricular ejection fraction to']","['Spironolactone', 'spironolactone 25\xa0mg daily or placebo', 'mineralocorticoid receptor antagonist spironolactone', 'spironolactone', 'placebo', 'placebo-controlled IMPRESS-AF', 'Spironolactone therapy']","['hospitalization', 'version quality of life questionnaire', 'Estimated glomerular filtration rate', 'exercise capacity, and quality of life', ""exercise capacity, E/e' ratio, or quality of life"", ""6-minute walk distance, E/e' ratio, quality of life, and hospital admissions"", 'peak oxygen consumption', ""exercise capacity, E/e' ratio, and quality of life"", 'peak oxygen consumption on cardiopulmonary exercise testing at 2\xa0years', 'Systolic blood pressure', '6-minute walking distance', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694539', 'cui_str': 'Chronic atrial fibrillation'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0990353', 'cui_str': 'Spironolactone 25 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",250.0,0.36997,"Systolic blood pressure was reduced by 7.2 mm Hg (95% CI, 2.2-12.3) in the spironolactone group versus placebo ( P =0.005).","[{'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Shantsila', 'Affiliation': 'North Worcestershire VTS St Helens and Knowsley Teaching Hospitals NHS Trust Prescot Merseyside United Kingdom.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Shahid', 'Affiliation': 'Institute of Cardiovascular Sciences University of Birmingham United Kingdom.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Deeks', 'Affiliation': 'Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham United Kingdom.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Calvert', 'Affiliation': 'NIHR Birmingham Biomedical Research Centre University of Birmingham United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'Department of Physiology Faculty of Medical and Health Sciences University of Auckland New Zealand.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Institute of Cardiovascular Sciences University of Birmingham United Kingdom.'}, {'ForeName': 'Paramjit S', 'Initials': 'PS', 'LastName': 'Gill', 'Affiliation': 'Academic Unit of Primary Care Warwick Medical School University of Warwick Coventry United Kingdom.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.016239']
2156,32911214,Cognitive behavioral therapy for persons living with HIV in China: A randomized pilot trial.,"BACKGROUND


Chinese persons living with HIV (PLWH) suffer from prevalent mental health issues. We aimed to develop a tailored cognitive behavioral therapy (CBT), test its feasibility, acceptability, and preliminary effects (depression, anxiety, and medication adherence) for Chinese PLWH.
METHODS


Twenty PLWH were assigned randomly. Intervention participants learned skills in CBT and relaxation training in a tailored group-based weekly 10-session project. Each session lasted for two hours and was delivered by nurses and volunteers. Control participants only received laboratory tests and free antiretroviral therapy (ART) medication. Feasibility and acceptability were descriptively summarized. Depression, anxiety, and ART medication adherence data were collected at the baseline (T0), after the intervention (T1) and after 6 months of follow-up (T2).
RESULTS


The average CBT attendance rate for all sessions was 60%. No participants in the intervention group dropped out of the study. All participants in the intervention group agreed that they could benefit from the CBT. Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1. However, no preliminary intervention effect was found at T2.
LIMITATIONS


The small sample size leads to a lack of representativeness in the study sample. We excluded participants with severe comorbidities, which may lead to an underestimate of the intervention effect of CBT among Chinese PLWH.
CONCLUSIONS


CBT is feasible and acceptable, demonstrating promising preliminary effects on anxiety and ART medication adherence among Chinese PLWH. Additional research is needed to test the effectiveness of this approach.",2020,Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1.,"['Twenty PLWH', 'persons living with HIV in China', 'Chinese persons living with HIV (PLWH', 'participants with severe comorbidities, which may lead to an underestimate of the intervention effect of CBT among Chinese PLWH']","['CBT', 'CBT and relaxation training', 'tailored cognitive behavioral therapy (CBT', 'Cognitive behavioral therapy', 'laboratory tests and free antiretroviral therapy (ART) medication']","['average CBT attendance rate', 'Feasibility and acceptability', 'anxiety and self-reported ART medication adherence', 'feasibility, acceptability, and preliminary effects (depression, anxiety, and medication adherence', 'Depression, anxiety, and ART medication adherence data', 'anxiety and ART medication adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",20.0,0.0619608,Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1.,"[{'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China. Electronic address: huyan@fudan.edu.cn.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center Affiliated with Fudan University, Shanghai 201508, China. Electronic address: luhongzhou@shphc.org.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center Affiliated with Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'School of Public Health, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Relf', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'Yaolin', 'Initials': 'Y', 'LastName': 'Pei', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.085']
2157,32911242,The effectiveness of a preoperative multi-component non-pharmacologic preparation on post-tonsillectomy pain: A randomized controlled clinical trial.,"INTRODUCTION


Tonsillectomy is a painful operation and some studies have suggested that preoperative non-pharmacologic preparations may decrease postoperative pain. In this randomized clinical trial study, we decided to determine which is more effective in the post-tonsillectomy pain; an informative booklet or a costly, time consuming, sophisticated, and multi-component preparation program.
MATERIALS AND METHODS


Patients were randomly assigned into two groups. In the booklet group, children and their parents only received an informative booklet as routine information preparation. On the other hand, in the multi-component group; in addition to receiving the same booklet, children and their parents received our multi-component pre-operative preparation program. The following items were included in the package: preoperative tour in the ward, an educational DVD, and therapeutic play intervention. All patients were observed at least for 8 h as a day case or ambulatory tonsillectomy. The pain score was recorded according to the visual analog scale for seven days. Finally, the post-tonsillectomy pain scores were compared in the two groups. The multi-component group included 121 children and booklet group 120.
RESULTS


Minimum and maximum age was 9 and 12 years. Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
CONCLUSION


Our data revealed that a new concept which is more cost-effective and concise booklet is as effective as costly and sophisticated methods in post-tonsillectomy pain among 9-12 years old children.",2020,"Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
","['post-tonsillectomy pain', '121 children and booklet group 120', '9-12 years old children', 'Patients']",['preoperative multi-component non-pharmacologic preparation'],"['pain score', 'tonsillectomy pain scores', 'postoperative pain']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",121.0,0.0305591,"Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: faramarzi@sums.ac.ir.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Roosta', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Roosta.Sareh@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Faramarzi', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: ali_faramarzi@sums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Salehi', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: salehiar@sums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Matani', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: inasmeh@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110359']
2158,32893322,One versus two anterior miniscrews for correcting upper incisor overbite and angulation: a retrospective comparative study.,"BACKGROUND


Miniscrews are effective devices for performing upper incisor intrusion. Different mechanics can be applied depending on the treatment objectives. This study aimed to evaluate the efficacy of one or two anterior miniscrews for upper incisor correction in cases of overbite and angulation in adult patients.
METHODS


Forty-four adults with deep overbite were divided into two groups: group 1 was treated with one miniscrew between upper central incisors and group 2 with two miniscrews between upper lateral incisors and canines. Incisor intrusion and length were measured from lateral cephalograms before treatment, after treatment and at least 12 months into retention (T0, T1 and T2). Forces were applied (90 g) from the miniscrews to the archwire using elastomeric chains. ANOVA analysis was used to determine whether differences between evaluation times were statistically significant.
RESULTS


Mean root resorption was 2.15 ± 0.85 mm, which ceased after active treatment. Overbite mean correction was - 3.23 ± 1.73 mm with no statistically significant relapse. Overbite correction and incisor intrusion were significantly greater in group 2 (- 3.80 ± 1.43 versus - 2.75 ± 1.63 for OB and 8.19 ± 3.66 versus 5.69 ± 2.66 for intrusion). Resorption and overbite correction were positively related. No counterclockwise rotation of the mandibular plane was observed.
CONCLUSIONS


Overbite correction can be performed by means of upper incisor intrusion without rotation of the mandibular plane. Correction of upper incisor intrusion and overbite is greater in patients treated with two miniscrews. The increase in upper incisor buccal angulation is greater with one miniscrew. Root resorption is positively related to the extent of intrusion. Stability is satisfactory regardless of whether one or two miniscrews are used.",2020,Overbite correction and incisor intrusion were significantly greater in group 2 (- 3.80 ± 1.43 versus - 2.75 ± 1.63 for OB and 8.19 ± 3.66 versus 5.69 ± 2.66 for intrusion).,"['Forty-four adults with deep overbite', 'cases of overbite and angulation in adult patients']",['one miniscrew between upper central incisors and group 2 with two miniscrews between upper lateral incisors and canines'],"['Root resorption', 'Resorption and overbite correction', 'Incisor intrusion and length', 'upper incisor buccal angulation', 'Overbite correction and incisor intrusion', 'Mean root resorption']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0266063', 'cui_str': 'Deep overbite'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0227040', 'cui_str': 'Structure of maxillary right lateral incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",44.0,0.0191748,Overbite correction and incisor intrusion were significantly greater in group 2 (- 3.80 ± 1.43 versus - 2.75 ± 1.63 for OB and 8.19 ± 3.66 versus 5.69 ± 2.66 for intrusion).,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Vela-Hernández', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gutiérrez-Zubeldia', 'Affiliation': 'In private practice, Vitoria, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'López-García', 'Affiliation': 'In private practice, Vitoria, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'García-Sanz', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Paredes-Gallardo', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain. Vanessa.paredes@uv.es.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Gandía-Franco', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain.'}, {'ForeName': 'Felicidad', 'Initials': 'F', 'LastName': 'Lasagabaster-Latorre', 'Affiliation': 'In private practice, Vitoria, Spain.'}]",Progress in orthodontics,['10.1186/s40510-020-00336-2']
2159,32893512,Randomized Controlled Trial Protocol for Evaluating the Effect of Group Education on Postmenopausal Sexual Dysfunction.,"OBJECTIVES


This study primarily aimed to determine the effect of group education on sexual dysfunction in postmenopausal women referred to health centers in Hamadan, Iran.
METHODS


This randomized controlled clinical trial conducted on 90 postmenopausal women from October 2018 to March 2019. Postmenopausal women who met the inclusion criteria and received approval of a psychiatrist were randomly divided into intervention and control groups (n = 45 in each group). They completed the demographic questionnaire and the Female Sexual Function Index questionnaire. Thereafter, four sessions of group training were conducted for women in the intervention group; these women were followed up for 1 month after the last training session. Data were analyzed using the SPSS ver. 16 software, and descriptive statistics and ANCOVA/ANOVA test were used for data analysis.
RESULTS


We found that the two groups were homogenous in most of the demographic variables and the data were normal. The total mean score of sexual function and standard deviation after the intervention was 23.70 ± 3.67 in the intervention group and 19.94 ± 3.64 in the control group, indicating that these scores were significantly higher in the intervention group than in the control group ( P  < 0.001).
CONCLUSIONS


Based on the results, group training is recommended to reduce sexual dysfunction in postmenopausal women at health centers.",2020,"The total mean score of sexual function and standard deviation after the intervention was 23.70 ± 3.67 in the intervention group and 19.94 ± 3.64 in the control group, indicating that these scores were significantly higher in the intervention group than in the control group ( P  < 0.001).
","['90 postmenopausal women from October 2018 to March 2019', 'postmenopausal women referred to health centers in Hamadan, Iran', 'Postmenopausal women who met the inclusion criteria and received approval of a psychiatrist', 'postmenopausal women at health centers']",['Group Education'],"['Postmenopausal Sexual Dysfunction', 'demographic questionnaire and the Female Sexual Function Index questionnaire', 'total mean score of sexual function and standard deviation', 'sexual dysfunction']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}]","[{'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",90.0,0.0357161,"The total mean score of sexual function and standard deviation after the intervention was 23.70 ± 3.67 in the intervention group and 19.94 ± 3.64 in the control group, indicating that these scores were significantly higher in the intervention group than in the control group ( P  < 0.001).
","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Alavipour', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Masoumi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Parsa', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of menopausal medicine,['10.6118/jmm.19020']
2160,32893515,Effect of Combined Herbal Capsule Menohelp on Hot Flashes and Night Sweats in Postmenopausal Women: A Single-Blind Randomized Controlled Trial.,"OBJECTIVES


Hot flashes and night sweats are the most common and annoying consequences of menopause. The present study aimed to investigate the effect of a combined herbal capsule (black cohosh, soy, potato, chaste tree, and burdock) on hot flashes and night sweats in postmenopausal women.
METHODS


The present study was a randomized clinical trial conducted on postmenopausal women who were referred to Hamadan health centers in 2018-2019. The patients were distributed randomly in two groups of 85 individuals using the permuted block technique. The intervention group received the Menohelp capsule 550 mg twice daily for eight weeks and those in the control group received placebo. Data was obtained using a demographic questionnaire and a night sweat checklist one week before and eight weeks after the intervention. Data analysis was done using Stata 13.
RESULTS


Data analysis revealed that means of hot flashes duration, frequency and intensity did not significantly decrease in the postintervention phase as compared to the pre-intervention phase in both the groups ( P  > 0.05). Comparative analyses of frequency and intensity of night sweats in the two groups revealed that both variables decreased after intervention with the Menohelp capsule ( P  < 0.05).
CONCLUSIONS


This study revealed that combined herbal medicine (Menohelp) was effective in reducing the frequency and intensity of night sweats. Therefore, it can be used to reduce night sweats in postmenopausal women.",2020,"RESULTS


Data analysis revealed that means of hot flashes duration, frequency and intensity did not significantly decrease in the postintervention phase as compared to the pre-intervention phase in both the groups ( P  > 0.05).","['postmenopausal women who were referred to Hamadan health centers in 2018-2019', 'Postmenopausal Women', 'postmenopausal women']","['Menohelp capsule', 'Combined Herbal Capsule Menohelp', 'combined herbal medicine (Menohelp', 'combined herbal capsule (black cohosh, soy, potato, chaste tree, and burdock', 'placebo']","['frequency and intensity of night sweats', 'hot flashes duration, frequency and intensity', 'Hot Flashes and Night Sweats']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0771967', 'cui_str': 'Black Cohosh Extract'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0752339', 'cui_str': 'Chasteberry Tree'}, {'cui': 'C0996995', 'cui_str': 'Burdock, Greater'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0473243,"RESULTS


Data analysis revealed that means of hot flashes duration, frequency and intensity did not significantly decrease in the postintervention phase as compared to the pre-intervention phase in both the groups ( P  > 0.05).","[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Shayan', 'Affiliation': 'Department of Midwifery, Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Masoumi', 'Affiliation': 'Department of Midwifery, Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Zahramid2001@gmail.com.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Department of Midwifery, Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Khodayar', 'Initials': 'K', 'LastName': 'Oshvandi', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of menopausal medicine,['10.6118/jmm.20002']
2161,32893536,[Post-marketing pharmaco-economics evaluation of Jinye Baidu Granules].,"To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.",2020,"Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.","['Patients from 10 hospitals', 'acute upper respiratory tract infection']",['Jinye Baidu Granules'],"['baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes', 'total recovery rate of symptoms and signs', 'cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0264222', 'cui_str': 'Acute upper respiratory infection'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",,0.0245879,"Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'School of Pharmacy, Peking University Beijing 100191, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Xie', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Yan-Shun', 'Initials': 'YS', 'LastName': 'Yu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Jiang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}]",Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,['10.19540/j.cnki.cjcmm.20200517.501']
2162,32890444,Methylene blue vs methyl aminolevulinate photodynamic therapy in the treatment of mild-to-moderate toenail onychomycosis: Short- and medium-term effects.,"Photodynamic therapy (PDT) has emerged as an interesting alternative option for onychomycosis treatment. The impact of a specific photosensitizer (PS) on the final result is an important factor to consider. We conducted a short- and medium-term controlled trial to compare the effectiveness of PDT in the treatment of mild-to-moderate onychomycosis when it is mediated by two different PSs. Twenty patients were randomized to receive nine sessions of PDT distributed over 16 weeks mediated either by methylene blue (MB/PDT group) or methyl aminolevulinate (MAL/PDT group). Onychomycosis severity index (OSI) and nail involvement were checked along the study. Complete cure, treatment success, and clinical improvement were tabulated at 16 and 40-week follow-ups. OSI scores decreased significantly along the study, from 12.1 ± 5.4 to 3.6 ± 3.2 (MB/PDT group) and from 14.8 ± 6.0 to 5.4 ± 4.4 (MAL/PDT group). At 16-week follow-up, only 20% of the patients in the MB/PDT group reached complete cure and none in the group of MAL/PDT. At 40-week follow-up, complete cure rates were 70% and 40% in the MB/PDT group and MAL/PDT group respectively. Both modalities showed good outcomes in treatment of moderate toenail onychomycosis. MB/PDT showed a faster action but with relapse rates slightly higher than MAL/PDT.",2020,"At 40-week follow-up, complete cure rates were 70% and 40% in the MB/PDT group and MAL/PDT group respectively.","['Twenty patients', 'mild-to-moderate toenail onychomycosis']","['Photodynamic therapy (PDT', 'MB/PDT', 'Methylene blue vs. methyl aminolevulinate photodynamic therapy', 'PDT distributed over 16\u2009weeks mediated either by methylene blue (MB/PDT group) or methyl aminolevulinate (MAL/PDT', 'specific photosensitizer (PS', 'PDT']","['Complete cure, treatment success and clinical improvement', 'complete cure rates', 'complete cure', 'Onychomycosis severity index (OSI) and nail involvement', 'OSI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C1134467', 'cui_str': 'methyl 5-aminolevulinate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024551', 'cui_str': 'Malayalam language'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0220669,"At 40-week follow-up, complete cure rates were 70% and 40% in the MB/PDT group and MAL/PDT group respectively.","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Alberdi', 'Affiliation': 'Private Clinic of Dr. Alberdi, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Institute of Physical Chemistry Rocasolano, CSIC, Madrid, Spain.'}]",Dermatologic therapy,['10.1111/dth.14280']
2163,32895004,"Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions.","BACKGROUND


The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis.
METHODS


From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES.
RESULTS


Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%;  P <0.01) and target vessel myocardial infarction (4.2% versus 7.6%;  P <0.01) were significantly lower in BP-SES than in DP-EES. No difference in the outcome between the stents was shown in patients with non-small vessel lesions. In patients with calcified lesions, target lesion failure (12.2% versus 6.9%;  P =0.056), and cardiac death (1.9% versus 0.3%;  P =0.081) were numerically higher in DP-EES than in BP-SES. In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES. Stent thrombosis was similar between the stents in both lesion groups.
CONCLUSIONS


Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01356888, NCT01939249, NCT02389946.",2020,"In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES.","['patients with non-small vessel lesions', 'total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available', 'patients with more complex disease representing a higher risk of target lesion failure', 'Subjects']","['polymer everolimus-eluting stent (DP-EES', 'Orsiro Sirolimus Eluting Coronary Stent System', 'ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES', 'DP-EES', 'Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents']","['BP-SES', 'De Novo or Restenotic Coronary Artery Lesions ', 'Coronary lesions', 'target lesion failure', 'Stent thrombosis', 'Safety and Effectiveness', 'cardiac death', 'target vessel myocardial infarction', 'vessel myocardial infarction in DP-EES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0205168', 'cui_str': 'Thin'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]",1553.0,0.0742964,"In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES.","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Dan', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kolm', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Switzerland (S.W.).'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiology, Shonan Kamakura General Hospital, Japan (S.S.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA (D.E.K.).'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009189']
2164,32896527,"Early visual cortex response for sound in expert blind echolocators, but not in early blind non-echolocators.","Echolocation is a perceptual and navigational skill that can be acquired by some individuals. Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes. Expert human echolocators benefit from using this technique not only in controlled environments but also in their everyday lives. In the current study, we investigate the effect of echolocation on blind people's auditory spatial abilities at the cortical level. In an auditory spatial bisection task, we tested people who are early blinds and early blind expert echolocators, along with sighted people. Our results showed that there is similar early activation (50-90 ms) in the posterior area of the scalp for both early blind expert echolocators and sighted participants, but not in the early blind group. This activation was related to sound stimulation, and it is contralateral to the position of the sound in space. These findings indicate that echolocation is a good substitute for the visual modality that enables the development of auditory spatial representations when vision is not available.",2020,"Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes.","['people who are early blinds and early blind expert echolocators, along with sighted people']",['echolocation'],['Early visual cortex response'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0013529', 'cui_str': 'Echolocation'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}]",,0.0717283,"Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tonelli', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy; Department of Translational Research of New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. Electronic address: tonelli.alessia@gmail.com.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Campus', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107617']
2165,32897010,[The effectiveness of recombinant interferon alpha-2b in the treatment of chronic recurrent bacterial prostatitis].,"INTRODUCTION


Chronic recurrent bacterial prostatitis (HRBP) affects the reproductive function and negatively affects the quality of life of men. The multifactorial pathogenesis of this disease causes the failure of antibiotic therapy and some cases, requires an in-depth study of the mechanisms of disease development and additional treatment methods.
OBJECTIVES


of the study: to study of the effectiveness of immunoactive therapy (recombinant interferon alpha-2b with an antioxidant complex) in combination with antibacterial therapy in patients with HRBP.
MATERIALS AND METHODS


Prospective trial: examination and treatment of 62 patients. Two groups: I (study) group (n=31) received antibacterial therapy (ABT) and a therapy with recombinant IFN Alpha-2b based medication with antioxidant complex (vitamins E and C), II (control) group (n=31) received only ABT. The examination plan included questionnaires (NIH - CPSI, IPSS, Hamilton), general blood and urine tests, biochemical blood tests, urethral scrapings for PCR diagnostics, plasma testosterone, native, electron microscopy, culture test and immunoferment analysis of the prostate sercet, uroflowmetry, Transrectal ultrasonography (TRUS).
RESULTS


When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.",2020,"When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.","['Chronic recurrent bacterial prostatitis (HRBP', 'patients with HRBP', '62 patients', 'chronic recurrent bacterial prostatitis']","['immunoactive therapy (recombinant interferon alpha-2b with an antioxidant complex', 'antibacterial therapy (ABT) and a therapy with recombinant IFN Alpha-2b based medication with antioxidant complex (vitamins E and C), II (control) group (n=31) received only ABT', 'recombinant interferon alpha-2b']","['questionnaires (NIH - CPSI, IPSS, Hamilton), general blood and urine tests, biochemical blood tests, urethral scrapings for PCR diagnostics, plasma testosterone, native, electron microscopy, culture test and immunoferment analysis of the prostate sercet, uroflowmetry, Transrectal ultrasonography (TRUS']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0748023', 'cui_str': 'Bacterial prostatitis'}, {'cui': 'C0062748', 'cui_str': 'histidine rich basic peptide (Aplysia)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}]",62.0,0.038075,"When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.","[{'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Ibishev', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mantsov', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Krainii', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2166,32681911,Effects of Induced Astigmatism on Spectral Domain-OCT Angiography Quantitative Metrics.,"PURPOSE


To analyze the effect of induced astigmatism on en-face spectral-domain optical coherence tomography angiography quantitative metrics.
DESIGN


Prospective crossover study.
METHODS


Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a 3 × 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA). Quantitative parameters, including foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD) were corrected for magnification secondary to axial length and analyzed. Univariate linear regressions were performed within each eye to correlate quantitative metrics to the level of an induced astigmatic cylinder.
RESULTS


Fifteen eyes from 15 patients were imaged. Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001). For every 1-D increase in induced astigmatism, the resulting decrease in the inner ring superior quadrant was 12% greater for VD and 16% greater for PD versus that in the inferior quadrant. The resulting decrease in the inner ring nasal quadrant was 40% greater for VD and 48% greater for PD versus that in the temporal quadrant.
CONCLUSIONS


Increasing levels of induced WTR astigmatism correlated with globally diminishing VD and PD, was more symmetrical for vertical than horizontal quadrants, and was most pronounced nasally. This may be due to a high prevalence of horizontally oriented vessels nasally and the horizontal optical defocus induced by WTR astigmatism.",2020,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","['Fifteen eyes from 15 patients were imaged', 'Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a']","['Induced Astigmatism', '3\xa0× 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA']","['VD and PD', 'foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD', 'inner ring nasal quadrant', 'Spectral Domain-OCT Angiography Quantitative Metrics', 'induced WTR astigmatism']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1719796', 'cui_str': 'With-the-rule astigmatism'}]",15.0,0.026434,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","[{'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Jung', 'Affiliation': 'East Bay Retina Consultants, Inc., Oakland, California, USA; Department of Ophthalmology, Universtiy of California, San Francisco, San Francisco, California, USA. Electronic address: jung.jesse@gmail.com.'}, {'ForeName': 'Yu Qiang', 'Initials': 'YQ', 'LastName': 'Soh', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sha', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA; Silicon Valley Eyecare Optometry, Santa Clara, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Durbin', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Quan V', 'Initials': 'QV', 'LastName': 'Hoang', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore; Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia College of Physicians and Surgeons, New York, New York, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.005']
2167,32900264,Association of Alcohol Intake With Hypertension in Type 2 Diabetes Mellitus: The ACCORD Trial.,"Background Heavy alcohol consumption has a well-established association with hypertension. However, doubt persists whether moderate alcohol consumption has a similar link. This relationship is not well-studied in patients with diabetes mellitus. We aimed to describe the association of alcohol consumption with prevalent hypertension in participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial. Methods and Results Alcohol consumption was categorized as none, light (1-7 drinks/week), moderate (8-14 drinks/week), and heavy (≥15 drinks/week). Blood pressure was categorized using American College of Cardiology/American Heart Association guidelines as normal, elevated blood pressure, stage 1 hypertension, and stage 2 hypertension. Multivariable logistic regression was used to explore the association between alcohol consumption and prevalent hypertension. A total of 10 200 eligible participants were analyzed. Light alcohol consumption was not associated with elevated blood pressure or any stage hypertension. Moderate alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (odds ratio [OR], 1.79; 95% CI, 1.04-3.11,  P =0.03; OR, 1.66; 95% CI, 1.05-2.60,  P =0.03; and OR, 1.62; 95% CI, 1.03-2.54,  P =0.03, respectively). Heavy alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (OR, 1.91; 95% CI, 1.17-3.12,  P =0.01; OR, 2.49; 95% CI, 1.03-6.17,  P =0.03; and OR, 3.04; 95% CI, 1.28-7.22,  P =0.01, respectively). Conclusions Despite prior research, our findings show moderate alcohol consumption is associated with hypertension in patients with type 2 diabetes mellitus and elevated cardiovascular risk. We also note a dose-risk relationship with the amount of alcohol consumed and the degree of hypertension.",2020,"Heavy alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (OR, 1.91; 95% CI, 1.17-3.12,  P =0.01; OR, 2.49; 95% CI, 1.03-6.17,  P =0.03; and OR, 3.04; 95% CI, 1.28-7.22,  P =0.01, respectively).","['patients with type 2 diabetes mellitus and elevated cardiovascular risk', 'Type 2 Diabetes Mellitus', 'A total of 10\xa0200 eligible participants were analyzed', 'prevalent hypertension in participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial', 'patients with diabetes mellitus']","['Alcohol Intake With Hypertension', ' Heavy alcohol consumption']","['elevated blood pressure or any stage hypertension', 'Moderate alcohol consumption', 'elevated blood pressure, stage 1, and stage 2 hypertension', 'Blood pressure', 'Heavy alcohol consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]",10200.0,0.0573236,"Heavy alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (OR, 1.91; 95% CI, 1.17-3.12,  P =0.01; OR, 2.49; 95% CI, 1.03-6.17,  P =0.03; and OR, 3.04; 95% CI, 1.28-7.22,  P =0.01, respectively).","[{'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Mayl', 'Affiliation': 'Section of Internal Medicine Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'German', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Upadhya', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Prashant D', 'Initials': 'PD', 'LastName': 'Bhave', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Yeboah', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Singleton', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017334']
2168,32900325,The cost-effectiveness of adjunctive corticosteroids for patients with septic shock.,"OBJECTIVE


To determine whether hydrocortisone is a cost-effective treatment for patients with septic shock.
DESIGN


Data linkage-based cost-effectiveness analysis.
SETTING


New South Wales and Queensland intensive care units.
PARTICIPANTS AND INTERVENTION


Patients with septic shock randomly assigned to treatment with hydrocortisone or placebo in the Adjunctive Glucocorticoid Therapy in Patients with Septic Shock (ADRENAL) trial.
MAIN OUTCOME MEASURES


Health-related quality of life at 6 months using the EuroQoL 5-dimension 5-level questionnaire. Data on hospital resource use and costs were obtained by linking the ADRENAL dataset to government administrative health databases. Clinical outcomes included mortality, health-related quality of life, and quality-adjusted life-years gained; economic outcomes included hospital resource use, costs and cost-effectiveness from the health care payer perspective. We also assessed cost-effectiveness by sex. To increase the precision of cost-effectiveness estimates, we conducted unrestricted bootstrapping.
RESULTS


Of 3800 patients in the ADRENAL trial, 1772 (46.6%) were eligible and 1513 (85.4% of those eligible) were included. There was no difference between hydrocortisone or placebo groups in regards to mortality (218/742 [29.4%]  v  227/759 [29.9%]; HR, 0.93; 95% CI, 0.78-1.12;  P  = 0.47), mean number of QALYs gained (0.10 ± 0.09  v  0.10 ± 0.09;  P  = 0.52), or total hospital costs (A$73 515 ± 61 376  v  A$69 748 ± 61 793; mean difference, A$3767; 95% CI, -A$2891 to A$10 425;  P  = 0.27). The incremental cost of hydrocortisone was A$1 254 078 per quality-adjusted life-year gained. In females, hydrocortisone was cost-effective in 46.2% of bootstrapped replications and in males it was cost-effective in 2.7% of bootstrapped replications.
CONCLUSIONS


Adjunctive hydrocortisone did not significantly affect longer term mortality, health-related quality of life, health care resource use or costs, and is unlikely to be cost-effective.",2020,"There was no difference between hydrocortisone or placebo groups in regards to mortality (218/742 [29.4%]  v  227/759 [29.9%]; HR, 0.93; 95% CI, 0.78-1.12;  P  = 0.47), mean number of QALYs gained (0.10 ± 0.09  v  0.10 ± 0.09;  P  = 0.52), or total hospital costs (A$73 515 ± 61 376  v  A$69 748 ±","['patients with septic shock', 'New South Wales and Queensland intensive care units', 'Patients with septic shock randomly assigned to treatment with', 'Of 3800 patients in the ADRENAL trial, 1772 (46.6%) were eligible and 1513 (85.4% of those eligible) were included', 'Patients with Septic Shock (ADRENAL) trial']","['hydrocortisone or placebo', 'placebo', 'adjunctive corticosteroids', 'hydrocortisone', 'Adjunctive Glucocorticoid Therapy']","['cost-effectiveness', 'total hospital costs', 'mortality, health-related quality of life, and quality-adjusted life-years gained; economic outcomes included hospital resource use, costs and cost-effectiveness from the health care payer perspective', 'Health-related quality of life at 6 months using the EuroQoL 5-dimension 5-level questionnaire', 'precision of cost-effectiveness estimates', 'term mortality, health-related quality of life, health care resource use or costs', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.331299,"There was no difference between hydrocortisone or placebo groups in regards to mortality (218/742 [29.4%]  v  227/759 [29.9%]; HR, 0.93; 95% CI, 0.78-1.12;  P  = 0.47), mean number of QALYs gained (0.10 ± 0.09  v  0.10 ± 0.09;  P  = 0.52), or total hospital costs (A$73 515 ± 61 376  v  A$69 748 ±","[{'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Thompson', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia. kthompson@georgeinstitute.org.'}, {'ForeName': 'Colman B', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Myburgh', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Dorrilyn', 'Initials': 'D', 'LastName': 'Rajbhandari', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Ashwani', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Finfer', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
2169,32914038,Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT): A Bayesian Adaptive Platform Trial to Develop Precision Medicines for Patients With Glioblastoma.,"PURPOSE


Adequately prioritizing the numerous therapies and biomarkers available in late-stage testing for patients with glioblastoma (GBM) requires an efficient clinical testing platform. We developed and implemented INSIGhT (Individualized Screening Trial of Innovative Glioblastoma Therapy) as a novel adaptive platform trial (APT) to develop precision medicine approaches in GBM.
METHODS


INSIGhT compares experimental arms with a common control of standard concurrent temozolomide and radiation therapy followed by adjuvant temozolomide. The primary end point is overall survival. Patients with newly diagnosed unmethylated GBM who are  IDH  R132H mutation negative and with genomic data available for biomarker grouping are eligible. At the initiation of INSIGhT, three experimental arms (neratinib, abemaciclib, and CC-115), each with a proposed genomic biomarker, are tested simultaneously. Initial randomization is equal across arms. As the trial progresses, randomization probabilities adapt on the basis of accumulating results using Bayesian estimation of the biomarker-specific probability of treatment impact on progression-free survival. Treatment arms may drop because of low probability of treatment impact on overall survival, and new arms may be added. Detailed information on the statistical model and randomization algorithm is provided to stimulate discussion on trial design choices more generally and provide an example for other investigators developing APTs.
CONCLUSION


INSIGhT (NCT02977780) is an ongoing novel biomarker-based, Bayesian APT for patients with newly diagnosed unmethylated GBM. Our goal is to dramatically shorten trial execution timelines while increasing scientific power of results and biomarker discovery using adaptive randomization. We anticipate that trial execution efficiency will also be improved by using the APT format, which allows for the collaborative addition of new experimental arms while retaining the overall trial structure.",2019,"(Individualized Screening Trial of Innovative Glioblastoma Therapy) as a novel adaptive platform trial (APT) to develop precision medicine approaches in GBM.
","['patients with glioblastoma (GBM', 'patients with newly diagnosed unmethylated GBM', 'Patients with newly diagnosed unmethylated GBM who are  IDH  R132H mutation negative and with genomic data available for biomarker grouping are eligible', 'Patients With Glioblastoma']","['INSIGhT', 'standard concurrent temozolomide and radiation therapy followed by adjuvant temozolomide', 'Innovative Glioblastoma Therapy (INSIGhT']",['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.147939,"(Individualized Screening Trial of Innovative Glioblastoma Therapy) as a novel adaptive platform trial (APT) to develop precision medicine approaches in GBM.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Alexander', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Trippa', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gaffey', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Arrillaga-Romany', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Eudocia Q', 'Initials': 'EQ', 'LastName': 'Lee', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Mikael L', 'Initials': 'ML', 'LastName': 'Rinne', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Manmeet S', 'Initials': 'MS', 'LastName': 'Ahluwalia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fell', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'de Groot', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Drappatz', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Lassman', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Meredith', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'L Burt', 'Initials': 'LB', 'LastName': 'Nabors', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Santagata', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'University of Virginia Health System, Charlottesville, VA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Welch', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Ligon', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",JCO precision oncology,['10.1200/PO.18.00071']
2170,32915158,Motivation Predicts Change in Nurses' Physical Activity Levels During a Web-Based Worksite Intervention: Results From a Randomized Trial.,"BACKGROUND


Low physical activity levels can negatively affect the health of nurses. Given the low physical activity levels reported by nurses, there is a clear need for brief and economical interventions designed to increase physical activity levels in this population. We developed a web-based intervention that used motivational strategies to increase nurses' physical activity levels. The intervention provided the nurses with feedback from an activity monitor coupled with a web-based individual, friend, or team physical activity challenge.
OBJECTIVE


In this parallel-group randomized trial, we examine whether nurses' motivation at baseline predicted changes in objectively measured physical activity levels during the 6-week intervention.
METHODS


The participants were 76 nurses (n=74, 97% female; mean age 46, SD 11 years) randomly assigned to 1 of 3 physical activity challenge conditions: (1) individual, (2) friend, or (3) team. The nurses completed a web-based questionnaire designed to assess motivational regulations for physical activity levels before the intervention and wore a Tractivity activity monitor before and during the 6-week intervention. We analyzed data using multilevel modeling for repeated measures.
RESULTS


The nurses' physical activity levels increased (linear estimate=10.30, SE 3.15; P=.001), but the rate of change decreased over time (quadratic estimate=-2.06, SE 0.52; P<.001). External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
CONCLUSIONS


Our findings provide evidence that an intervention that incorporates self-monitoring and physical activity challenges can be generally effective in increasing nurses' physical activity levels in the short term. They also suggest that drawing solely on organismic integration theory to predict changes in physical activity levels among the nurses participating in web-based worksite interventions may have been insufficient. Future research should examine additional personal (eg, self-efficacy) and occupational factors (eg, shift length and shift type) that influence physical activity levels to identify potential targets for intervention among nurses.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04524572; https://clinicaltrials.gov/ct2/show/NCT04524572.",2020,"External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
","['participants were 76 nurses (n=74, 97% female; mean age 46, SD 11 years) randomly assigned to 1 of 3']","['nurses with feedback from an activity monitor coupled with a web-based individual, friend, or team physical activity challenge', 'physical activity challenge conditions: (1) individual, (2) friend, or (3) team', 'Worksite Intervention']","[""Nurses' Physical Activity Levels"", ""nurses' physical activity levels"", 'physical activity levels']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",76.0,0.0444141,"External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brunet', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tulloch', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wolfe Phillips', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Pipe', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Reed', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/11543']
2171,32915162,"Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.","BACKGROUND


In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2.
OBJECTIVE


This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting.
METHODS


The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy.
RESULTS


Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot.
CONCLUSIONS


This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18051.",2020,"More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness.","['young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection', '41 participants were enrolled in the community-based pilot', 'Young Men', 'Men and Transgender Youth of Color (Phase 3']",['Employment Intervention Program'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],41.0,0.0463592,"More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness.","[{'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Hill', 'Affiliation': 'Planned Parenthood Great Plains, Overland Park, KS, United States.'}, {'ForeName': 'Darnell N', 'Initials': 'DN', 'LastName': 'Motley', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rosentel', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'VandeVusse', 'Affiliation': 'Guttmacher Institute, New York, NY, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Kipke', 'Affiliation': ""Division of Research on Children, Youth, and Families, Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Reisner', 'Affiliation': 'Fenway Health, The Fenway Institute, Boston, MA, United States.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Rupp', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'West Goolsby', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'McCumber', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Renshaw', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, United States.'}]",JMIR research protocols,['10.2196/18051']
2172,32907591,Caffeine supplementation induces higher IL-6 and IL-10 plasma levels in response to a treadmill exercise test.,"BACKGROUND


An acute bout of exercise induces an inflammatory response characterized by increases in several cytokines. Caffeine ingestion could modify this inflammatory response. The aim of this study was to determine the effects of caffeine supplementation on plasma levels of cytokines, mainly IL-10 and IL-6, in response to exercise.
METHODS


In a randomized, crossover, double-blinded study design, thirteen healthy, well-trained recreational male athletes performed, on two different occasions, a treadmill exercise test (60 min at 70% VO 2 max) after ingesting 6 mg/kg body mass of caffeine or placebo. Blood samples were taken before exercising, immediately after finishing and 2 h after finishing the exercise. Plasma concentrations of IL-10, IL-6, IL-1β, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ, adrenaline, cortisol and cyclic adenosine monophosphate (cAMP) were determined. The capacity of whole blood cultures to produce cytokines in response to endotoxin (LPS) was also determined. Changes in blood variables were analyzed using a time (pre-exercise, post-exercise, recovery) x condition (caffeine, placebo) within-between subjects ANOVA with repeated measures.
RESULTS


Caffeine supplementation induced higher adrenaline levels in the supplemented participants after exercise (257.3 ± 53.2 vs. 134.0 ± 25.7 pg·mL - 1 , p = 0.03) and higher cortisol levels after recovery (46.4 ± 8.5 vs. 32.3 ± 5.6 pg·mL - 1 , p = 0.007), but it did not influence plasma cAMP levels (p = 0.327). The exercise test induced significant increases in IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels remaining high after recovery. Caffeine supplementation influenced only IL-6 (3.04 ± 0.40 vs. 3.89 ± 0.62 pg·mL - 1 , p = 0.003) and IL-10 (2.42 ± 0.54 vs. 3.47 ± 0.72 pg·mL - 1 , p = 0.01) levels, with higher concentrations after exercise in the supplemented condition. No effect of caffeine was observed on the in vitro stimulated cytokine production.
CONCLUSIONS


The results of the present study indicate a significant influence of caffeine supplementation increasing the response to exercise of two essential cytokines such as IL-6 and IL-10. However, caffeine did not influence changes in the plasma levels of other cytokines measured and the in vitro-stimulated cytokine production.",2020,"The exercise test induced significant increases in IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels remaining high after recovery.","['thirteen healthy, well-trained recreational male athletes']","['Caffeine supplementation', 'treadmill exercise test', 'caffeine', 'condition (caffeine, placebo', 'caffeine or placebo', 'Caffeine ingestion', 'caffeine supplementation']","['higher IL-6 and IL-10 plasma levels', 'plasma levels of cytokines, mainly IL-10 and IL-6', 'higher cortisol levels', 'adrenaline levels', 'blood variables', 'IL-6', 'IL-10', 'plasma cAMP levels', 'plasma levels', 'Plasma concentrations of IL-10, IL-6, IL-1β, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ, adrenaline, cortisol and cyclic adenosine monophosphate (cAMP', 'IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0201998', 'cui_str': 'Epinephrine measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.259623,"The exercise test induced significant increases in IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels remaining high after recovery.","[{'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Rodas', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Fundamental Biology and Health Sciences, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Nursing and Physiotherapy, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain. sonia.martinez@uib.es.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Aguilo', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Nursing and Physiotherapy, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Tauler', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Fundamental Biology and Health Sciences, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00375-4']
2173,32907614,The multi-biomarker disease activity test for assessing response to treatment strategies using methotrexate with or without prednisone in the CAMERA-II trial.,"OBJECTIVES


The CAMERA-II trial compared two tight-control, treat-to-target strategies, initiating methotrexate with prednisone (MTX+pred) or MTX with placebo (MTX+plac), in early RA-patients. The multi-biomarker disease activity (MBDA) blood test objectively measures RA disease activity with a score of 1-100. In CAMERA-II, response profiles of the MBDA score, its individual biomarkers, and DAS28 were assessed.
METHODS


We evaluated 92 patients from CAMERA-II of whom clinical data and serum for MBDA testing at baseline and ≥ 1 time-point from months 1, 2, 3, 4, 5, 6, 9, or 12 were available. Changes (∆) from baseline for DAS28 and MBDA score and comparisons of ∆DAS28 and ∆MBDA score over time within the MTX+pred versus the MTX+plac strategy were tested for significance with t tests. Changes in biomarker concentration from baseline to months 1-5 were tested with Wilcoxon signed rank test and tested for difference between treatment arms by Mann-Whitney U test.
RESULTS


MBDA and DAS28 showed similar response profiles, with gradual improvement over the first 6 months in the MTX+plac group, and in the MTX+pred group faster improvement during month 1, followed by gradual improvement. The 12 MBDA biomarkers could be grouped into 4 categories of response profiles, with significant responses for 4 biomarkers during the MTX+plac strategy and 9 biomarkers during the MTX+pred strategy.
CONCLUSIONS


MBDA tracked treatment response in CAMERA-II similarly to DAS28. More individual MBDA biomarkers tracked treatment response to MTX+pred than to MTX+plac. Four response profiles could be observed.
TRIAL REGISTRATION


CAMERA-II International Standard Randomised Controlled Trial Number: ISRCTN 70365169 . Registered on 29 March 2006, retrospectively registered.",2020,"MBDA and DAS28 showed similar response profiles, with gradual improvement over the first 6 months in the MTX+plac group, and in the MTX+pred group faster improvement during month 1, followed by gradual improvement.","['92 patients from CAMERA-II of whom clinical data and serum for MBDA testing at baseline and\u2009≥\u20091 time-point from months 1, 2, 3, 4, 5, 6, 9, or 12 were available']","['MTX+plac', 'methotrexate with or without prednisone', 'methotrexate with prednisone (MTX+pred) or MTX with placebo (MTX+plac']","['DAS28 and MBDA score and comparisons of ∆DAS28 and ∆MBDA score', 'biomarker concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",92.0,0.106989,"MBDA and DAS28 showed similar response profiles, with gradual improvement over the first 6 months in the MTX+plac group, and in the MTX+pred group faster improvement during month 1, followed by gradual improvement.","[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Jurgens', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Safy-Khan', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands. marysafy@hotmail.com.'}, {'ForeName': 'M J H', 'Initials': 'MJH', 'LastName': 'de Hair', 'Affiliation': 'Novartis Pharma BV, Amsterdam, the Netherlands.'}, {'ForeName': 'J W J', 'Initials': 'JWJ', 'LastName': 'Bijlsma', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'P M J', 'Initials': 'PMJ', 'LastName': 'Welsing', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tekstra', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'F P J G', 'Initials': 'FPJG', 'LastName': 'Lafeber', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Sasso', 'Affiliation': 'Crescendo Bioscience, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'J W G', 'Initials': 'JWG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis research & therapy,['10.1186/s13075-020-02293-x']
2174,32907617,"Interleukin-6 receptor blockade or TNFα inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials.","BACKGROUND


Diabetes is common in patients with rheumatoid arthritis (RA). Interleukin (IL)-6 is implicated in both the pathogenesis of RA and in glucose homeostasis; this post hoc analysis investigated the effects of IL-6 receptor vs. tumour necrosis factor inhibition on glycosylated haemoglobin (HbA1c) in patients with RA with or without diabetes.
METHODS


Data were from two placebo-controlled phase III studies of subcutaneous sarilumab 150/200 mg q2w + methotrexate or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and a phase III monotherapy study of sarilumab 200 mg q2w vs. adalimumab 40 mg q2w. Patients with diabetes were identified by medical history or use of antidiabetic medication (patients with HbA1c ≥ 9% were excluded from all three studies). HbA1c was measured at baseline and weeks 12/24. Safety and efficacy were assessed in RA patients with or without diabetes.
RESULTS


Patients with diabetes (n = 184) were older, weighed more and exhibited higher RA disease activity than patients without diabetes (n = 1928). Regardless of diabetes status, in patients on background csDMARDs, least squares (LS) mean difference (95% CI) in change from baseline in HbA1c for sarilumab 150 mg/200 mg vs. placebo at week 24 was - 0.28 (- 0.40, - 0.16; nominal p <  0.0001) and - 0.42 (- 0.54, - 0.31; nominal p <  0.0001), respectively. Without csDMARDs, LS mean difference for sarilumab 200 mg vs. adalimumab 40 mg at week 24 was - 0.13 (- 0.22, - 0.04; nominal p = 0.0043). Greater reduction in HbA1c than placebo or adalimumab was observed at week 24 with sarilumab in patients with diabetes and/or baseline HbA1c ≥ 7%. There was no correlation between baseline/change from baseline in HbA1c and baseline/change from baseline in C-reactive protein, 28-joint Disease Activity Score, or haemoglobin, nor between HbA1c change from baseline and baseline glucocorticoid use. Medical history of diabetes or use of diabetes treatments had limited impact on safety and efficacy of sarilumab and was consistent with overall phase III findings in patients with RA.
CONCLUSIONS


In post hoc analyses, sarilumab was associated with a greater reduction in HbA1c than csDMARDs or adalimumab, independent of sarilumab anti-inflammatory effects. Prospective studies are required to further assess these preliminary findings.
TRIAL REGISTRATION


ClinTrials.gov NCT01061736: date of registration February 03, 2010; ClinTrials.gov NCT01709578: date of registration October 18, 2012; ClinTrials.gov NCT02332590: date of registration January 07, 2015.",2020,"In post hoc analyses, sarilumab was associated with a greater reduction in HbA1c than csDMARDs or adalimumab, independent of sarilumab anti-inflammatory effects.","['Patients with diabetes (n\u2009=\u2009184', 'patients with RA and diabetes', 'patients with RA with or without diabetes', 'RA patients with or without diabetes', 'patients with RA', 'patients with rheumatoid arthritis (RA', 'Patients with diabetes were identified by medical history or use of antidiabetic medication (patients with HbA1c ≥\u20099% were excluded from all three studies']","['Interleukin-6 receptor blockade or TNFα inhibition', 'subcutaneous sarilumab 150/200\u2009mg q2w\u2009+\u2009methotrexate or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs', 'sarilumab 200\u2009mg q2w vs. adalimumab 40\u2009mg q2w', 'placebo', 'adalimumab']","['Safety and efficacy', 'RA disease activity', 'C-reactive protein, 28-joint Disease Activity Score, or haemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.261879,"In post hoc analyses, sarilumab was associated with a greater reduction in HbA1c than csDMARDs or adalimumab, independent of sarilumab anti-inflammatory effects.","[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University Medical Center, 1000 Welch Road, Suite 203, Palo Alto, CA, 94304, USA. genovese@stanford.edu.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité University Medicine, Free University and Humboldt University of Berlin, Berlin, Germany.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hagino', 'Affiliation': 'Sanofi Genzyme, Bridgewater, NJ, USA.'}, {'ForeName': 'Karthinathan', 'Initials': 'K', 'LastName': 'Thangavelu', 'Affiliation': 'Sanofi Genzyme, Bridgewater, NJ, USA.'}, {'ForeName': 'Melitza', 'Initials': 'M', 'LastName': 'Iglesias-Rodriguez', 'Affiliation': 'Sanofi Genzyme, Bridgewater, NJ, USA.'}, {'ForeName': 'Gregory St', 'Initials': 'GS', 'LastName': 'John', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'González-Gay', 'Affiliation': 'University of Cantabria Hospital Universitario Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mandrup-Poulsen', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Arthritis research & therapy,['10.1186/s13075-020-02229-5']
2175,32912157,Phosphodiesterase 5 inhibitor sildenafil in patients with heart failure with preserved ejection fraction and combined pre- and postcapillary pulmonary hypertension: a randomized open-label pilot study.,"BACKGROUND


Heart failure with preserved ejection fraction (HFpEF) is frequently complicated by pulmonary hypertension (PH). A pulmonary vascular contribution could be considered as a substantial therapeutic target in HFpEF and PH and combined pre- and postcapillary PH (Cpc-PH).
METHODS


We enrolled 50 patients with HFpEF and Cpc-PH who were determined by echocardiography to have pulmonary artery systolic pressure (PASP) > 40 mmHg, pulmonary vascular resistance > 3 Wood units, and/or transpulmonary gradient > 15 mmHg.
RESULTS


The patients were assigned to the phosphodiesterase 5 (PDE5) inhibitor sildenafil group (25 mg TID for 3 months followed by 50 mg TID for 3 months; n = 30) or the control group (n = 20). In the sildenafil group after 6 months, the 6-min walk distance increased by 50 m (95% CI, 36 to 64 m); substantial improvement in NYHA functional class and exercise capacity during diastolic stress test were revealed; decreases in early mitral inflow to mitral annulus relaxation velocities ratio by 2.4 (95% CI, - 3.3 to - 1.4) and PASP by 17.0 mmHg (95% CI, 20.4 to 13.5) were observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion) increased by 0.42 cm (95% CI, 0.32 to 0.52 cm; P < 0.01 for all). No changes occurred in the control group.
CONCLUSIONS


In a subset of patients with HFpEF and Cpc-PH assessed by echocardiography, PDE5 inhibition was associated with an improvement in exercise capacity, pulmonary haemodynamic parameters, and right ventricular function. The role of sildenafil needs to be considered in randomized trials in selected patients with HFpEF with invasively confirmed Cpc-PH.
TRIAL REGISTRATION


Russian National Information System of Research, Development and Technology Data of Civilian Usage (NIS, https://rosrid.ru), registration number 01201257849 . Registered 20 April 2012. This manuscript adheres to the CONSORT guidelines.",2020,"In the sildenafil group after 6 months, the 6-min walk distance increased by 50 m (95% CI, 36 to 64 m); substantial improvement in NYHA functional class and exercise capacity during diastolic stress test were revealed; decreases in early mitral inflow to mitral annulus relaxation velocities ratio by 2.4 (95% CI, - 3.3 to - 1.4) and PASP by 17.0 mmHg (95% CI, 20.4 to 13.5) were observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion) increased by 0.42 cm (95% CI, 0.32 to 0.52 cm; P < 0.01 for all).","['selected patients with HFpEF with invasively confirmed Cpc-PH', 'patients with heart failure with preserved ejection fraction and combined pre- and postcapillary pulmonary hypertension', '40', '50 patients with HFpEF and Cpc-PH who were determined by echocardiography to have pulmonary artery systolic pressure (PASP) ']","['preserved ejection fraction (HFpEF', 'sildenafil', 'phosphodiesterase 5 (PDE5) inhibitor sildenafil', 'Phosphodiesterase 5 inhibitor sildenafil']","['mmHg, pulmonary vascular resistance', 'exercise capacity, pulmonary haemodynamic parameters, and right ventricular function', 'observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion', 'PASP', 'NYHA functional class and exercise capacity during diastolic stress test', 'early mitral inflow to mitral annulus relaxation velocities ratio', '6-min walk distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1283386', 'cui_str': 'Postcapillary pulmonary hypertension'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0757672', 'cui_str': 'Phosphodiesterase 5'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}]","[{'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080311', 'cui_str': 'Right ventricular function'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0225947', 'cui_str': 'Structure of anulus fibrosus of mitral orifice'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",50.0,0.121354,"In the sildenafil group after 6 months, the 6-min walk distance increased by 50 m (95% CI, 36 to 64 m); substantial improvement in NYHA functional class and exercise capacity during diastolic stress test were revealed; decreases in early mitral inflow to mitral annulus relaxation velocities ratio by 2.4 (95% CI, - 3.3 to - 1.4) and PASP by 17.0 mmHg (95% CI, 20.4 to 13.5) were observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion) increased by 0.42 cm (95% CI, 0.32 to 0.52 cm; P < 0.01 for all).","[{'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Belyavskiy', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany. evgeny.belyavskiy@charite.de.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Ovchinnikov', 'Affiliation': 'Out-Patient Department, Institute of Clinical Cardiology, National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Potekhina', 'Affiliation': 'Out-Patient Department, Institute of Clinical Cardiology, National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Fail', 'Initials': 'F', 'LastName': 'Ageev', 'Affiliation': 'Out-Patient Department, Institute of Clinical Cardiology, National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01671-2']
2176,32912192,Antibiotic prescribing and non-prescribing in nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA): study protocol for a cluster randomized controlled trial.,"BACKGROUND


Antibiotic overprescribing for suspected urinary tract infection (UTI) in nursing homes (NHs) is common. Typical clinical scenarios in which antibiotics are inappropriately prescribed include response to nonspecific signs and symptoms and/or a positive urine test in the absence of symptoms referable to the urinary tract. These and other scenarios for inappropriate antibiotic prescribing were addressed in a recent international Delphi study which resulted in the development of a decision tool for the empiric treatment of UTI in frail older adults. The aim of the current study is to implement this decision tool, by integrating it into the electronic health record (EHR) and providing education on its content and use, and to evaluate its effect on appropriate antibiotic prescribing. An additional aim is to evaluate the quality of the intervention and the implementation process.
METHODS


A cluster Randomized Controlled Trial (cRCT) is conducted in sixteen NHs and aims to include 897 residents diagnosed with suspected UTI. NHs in the intervention group use the EHR-integrated decision tool, and receive education for physicians and nursing staff; in the control group care as usual is provided. Data is collected through case report forms within the EHR at the day of diagnosis and at 3, 7, and 21 days thereafter. The primary outcome is appropriate antibiotic prescribing for suspected UTI at the day of diagnosis. Secondary outcomes include the course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality. Data on total antibiotic prescribing are additionally collected in the participating NHs 12 months before and during the study. Finally, the process evaluation combines cRCT data with questionnaires and qualitative interviews with NH professionals.
DISCUSSION


This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents. Study findings will elucidate the effect of the intervention on appropriate antibiotic prescribing for suspected UTI, and provide insight into the applicability of the decision tool in NHs in general and in specific subgroups of NH residents. With this study we aim to contribute to antibiotic stewardship efforts in long-term care.
TRIAL REGISTRATION


The ANNA study was registered at the Netherlands Trial Register on 26 February 2019, with identification number NTR NL7555 .",2020,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","['897 residents diagnosed with suspected UTI', '26 February 2019, with identification number NTR NL7555 ', 'frail older adults', 'nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA']",['Antibiotic prescribing and non-prescribing'],"['total antibiotic prescribing', 'appropriate antibiotic prescribing for suspected UTI at the day of diagnosis', 'course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0993058,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","[{'ForeName': 'Jeanine J S', 'Initials': 'JJS', 'LastName': 'Rutten', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'van Buul', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands. L.vanbuul@amsterdamumc.nl.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases division, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community care, Radboud Institute for Health Sciences, Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Natsch', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'Department of Family Medicine, School of Medicine, and the Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Veenhuizen', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees M P M', 'Initials': 'CMPM', 'LastName': 'Hertogh', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}]",BMC geriatrics,['10.1186/s12877-020-01662-0']
2177,32912311,Effects of acute hypobaric hypoxia on thermoregulatory and circulatory responses during cold air exposure.,"BACKGROUND


The thermoregulatory responses during simultaneous exposure to hypoxia and cold are not well understood owing to the opposite reactions of vasomotor tone in these two environments. Therefore, the purpose of this study was to investigate the influences of hypobaric hypoxia on various thermoregulatory responses, including skin blood flow (SkBF) during cold exposure.
METHODS


Ten subjects participated in two experimental conditions: normobaric normoxia with cold (NC, barometric pressure (P B ) = 760 mmHg) and hypobaric hypoxia with cold (HC, P B  = 493 mmHg). The air temperature was maintained at 28 °C for 65 min and gradually decreased to 19 °C for both conditions. The total duration of the experiment was 135 min.
RESULTS


The saturation of percutaneous oxygen (SpO 2 ) was maintained at 98-99% in NC condition, but decreased to around 84% in HC condition. The rectal and mean skin temperatures showed no significant differences between the conditions; however, the forehead temperature was higher in HC condition than in NC condition. The pulse rate increased in HC condition, and there was a strong negative relationship between SpO 2  and pulse rate (r = - 0.860, p = 0.013). SkBF and blood pressure showed no significant differences between the two conditions.
CONCLUSION


These results suggest that hypobaric hypoxia during cold exposure did not alter the overall thermoregulatory responses. However, hypobaric hypoxia did affect pulse rate regardless of cold exposure.",2020,"The rectal and mean skin temperatures showed no significant differences between the conditions; however, the forehead temperature was higher in HC condition than in NC condition.","['cold air exposure', 'Ten subjects participated in two experimental conditions']","['normobaric normoxia with cold (NC, barometric pressure (P B ) = 760 mmHg) and hypobaric hypoxia with cold (HC, P B  = 493 mmHg', 'acute hypobaric hypoxia']","['pulse rate increased in HC condition', 'overall thermoregulatory responses', 'forehead temperature', 'air temperature', 'rectal and mean skin temperatures', 'thermoregulatory and circulatory responses', 'saturation of percutaneous oxygen (SpO 2 ', 'SkBF and blood pressure', 'skin blood flow (SkBF']","[{'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0237510', 'cui_str': 'Barometric pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1532121', 'cui_str': 'Forehead temperature'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",10.0,0.0196911,"The rectal and mean skin temperatures showed no significant differences between the conditions; however, the forehead temperature was higher in HC condition than in NC condition.","[{'ForeName': 'Sora', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Graduate School of Design, Kyushu University, 4-9-1 Shiobaru, Minami-ku, Fukuoka, 815-8540, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Yasukochi', 'Affiliation': 'Department of Human Functional Genomics, Advanced Science Research Promotion Center, Mie University, 1577 Kurima-machiya, Tsu, Mie, 514-8507, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': 'Faculty of Engineering, Hokkaido University, N13 W8, Kita-ku, Sapporo, Hokkaido, 060-8628, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University, 4-9-1 Shiobaru, Minami-ku, Fukuoka, 815-8540, Japan. maeda@design.kyushu-u.ac.jp.'}]",Journal of physiological anthropology,['10.1186/s40101-020-00237-7']
2178,32913368,Correction: Phage Display of the Serpin Alpha-1 Proteinase Inhibitor Randomized at Consecutive Residues in the Reactive Centre Loop and Biopanned with or without Thrombin.,[This corrects the article DOI: 10.1371/journal.pone.0084491.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0084491.].,[],[],[],[],[],[],,0.0271319,[This corrects the article DOI: 10.1371/journal.pone.0084491.].,"[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Wadim L', 'Initials': 'WL', 'LastName': 'Matochko', 'Affiliation': ''}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Gierczak', 'Affiliation': ''}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Bhakta', 'Affiliation': ''}, {'ForeName': 'Ratmir', 'Initials': 'R', 'LastName': 'Derda', 'Affiliation': ''}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Sheffield', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238969']
2179,32913399,"A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people.","Background


GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial.
Methods


This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms.
Results


The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively.
Conclusion


The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.",2020,"The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively.","['healthy people', '45 healthy applicants', 'single center from October 2014 to March 2015']","['protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract', 'GS-3K8', 'GINST', 'GS-3K8 and GINST', 'placebo groups', 'placebo']","['incidence of ARI', 'rate of recruitment', 'duration of symptoms', 'overall rate', 'mean compliance rate', 'rates of recruitment, drug compliance, and successful follow-up', 'acute respiratory illness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0072494', 'cui_str': 'protopanaxadiol'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}, {'cui': 'C0032491', 'cui_str': 'Polygalacturonase'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.549673,"The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively.","[{'ForeName': 'Jeong-Hwan', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Pyo', 'Affiliation': 'International Ginseng and Herb Research Institute, Geumsan, Republic of Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}]",Journal of ginseng research,['10.1016/j.jgr.2019.01.002']
2180,32913443,An open-label randomised pilot trial on safety of wheat variety C273 in patients with adult celiac disease.,"Background


The only effective treatment for celiac disease (CeD) is gluten free diet (GFD). However, GFD is restrictive and efforts are being made to explore alternative therapies including safer wheat varieties. Wheat variety C273 has been previously identified to have reduced load of intact T-cell stimulatory epitopes  via in silico  and  in vitro  analysis.
Methods


Adult patients diagnosed with CeD and recovered on GFD were included in the study. Patients were randomised into two groups in a 2:1 ratio. Patients in group I had graded introduction of C273 wheat in diet, maintained for 24 weeks; in Group II, wheat was restricted with continuation of GFD. Clinical symptoms, serology [anti-tissue transglutaminase (anti-tTG), anti-endomysial antibody (anti-EMA)], circulating inflammatory biomarkers [intestinal fatty-acid binding protein (I-FABP), plasma citrulline, interferon-γ (IFN-γ)] and histology were evaluated periodically. Final evaluation was performed at week 28.
Results


A total of 15 patients were enrolled (Group I:  n  = 10, Group II:  n  = 5). All patients except two in Group I remained compliant. None of the remaining eight patients in group I developed symptoms. No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( p  > 0.05). Significant changes in plasma citrulline(29.87 ± 8.98  versus  36.58 ± 3.09,  p  = 0.049) and IFN-γ (44.56 ± 9.74  versus  33.50 ± 3.68;  p  = 0.031) were observed in Group I.
Conclusion


Consumption of C273 wheat did not result in development of symptoms or evident changes in serology and histology at 28 weeks. However, variations in circulating inflammatory markers were noted. Larger randomised trials are needed to corroborate these findings.
Clinical Trials Registry-India


CTRI/2018/06/014521.",2020,"No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( p  > 0.05).","['Adult patients diagnosed with CeD and recovered on GFD were included in the study', '15 patients were enrolled', 'patients with adult celiac disease']",['wheat variety C273'],"['serology (anti-tTG, anti-EMA) and histology', 'circulating inflammatory markers', 'IFN-γ', 'symptoms', 'Clinical symptoms, serology [anti-tissue transglutaminase (anti-tTG), anti-endomysial antibody (anti-EMA)], circulating inflammatory biomarkers [intestinal fatty-acid binding protein (I-FABP), plasma citrulline, interferon-γ (IFN-γ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238049', 'cui_str': 'Adult form of celiac disease'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}]","[{'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0529334', 'cui_str': 'transglutaminase 2'}, {'cui': 'C0443906', 'cui_str': 'Endomysial antibody'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}]",15.0,0.0395008,"No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( p  > 0.05).","[{'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Grover', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Parveen', 'Initials': 'P', 'LastName': 'Chhuneja', 'Affiliation': 'School of Agricultural Biotechnology, Punjab Agricultural University, Ludhiana, Punjab, India.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Midha', 'Affiliation': 'Department of Internal Medicine, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Arshdeep', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Ramit', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Mehta', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Ramneek', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'School of Animal Biotechnology, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India.'}, {'ForeName': 'Ekta', 'Initials': 'E', 'LastName': 'Bansal', 'Affiliation': 'Department of Biochemistry, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Deka', 'Affiliation': 'School of Animal Biotechnology, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Bansal', 'Affiliation': 'Statistician, Research and Development Centre, Dayanand Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Sood', 'Affiliation': 'Department of Pathology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Narang', 'Affiliation': 'Department of Pathology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, 6-E, Tagore Nagar, Civil Lines, Ludhiana, Punjab 141001, India.'}]",Therapeutic advances in gastroenterology,['10.1177/1756284820944089']
2181,32913576,Effects of Neuromuscular Electrical Stimulation (NMES) on salivary flow in healthy adults.,"Background


Neuromuscular electrical stimulation (NMES) is a method used for enhancing suprahyoid muscle activity and is widely applied as a treatment for dysphagia. Patients often complain of saliva pooling in the pharynx during NMES. Therefore, the purpose of this study was to investigate the changes in salivary flow during NMES.
Material and Methods


Twenty healthy adults participated in this study. Electrical stimulation was applied at constant strength for 60 minutes to the suprahyoid muscles using VitalStim®. Participants were examined under three conditions of NMES: sensory threshold plus 75% of the difference between sensory and pain thresholds (75% Stim), SensoryStim, and Sham. Saliva collections, using a 10-min spitting method, were performed seven times: before stimulation (S1), during stimulation (S2-S6), and 5 min after stimulation ended (S7).
Results


Significant differences were observed in saliva flow between S1 and S7, as well as S2 and S7 in 75% Stim.
Conclusions


This study indicates that an increase in saliva flow was promoted after NMES. Therefore, NMES may have effects on patients with xerostomia.  Key words: Neuromuscular electrical stimulation, suprahyoid muscle, sensory threshold, pain threshold, saliva flow.",2020,"Results


Significant differences were observed in saliva flow between S1 and S7, as well as S2 and S7 in 75% Stim.
","['patients with xerostomia', 'Twenty healthy adults participated in this study', 'healthy adults', 'Patients often complain of saliva pooling in the pharynx during NMES']","['\n\n\nNeuromuscular electrical stimulation (NMES', 'NMES', 'Neuromuscular Electrical Stimulation (NMES']","['Neuromuscular electrical stimulation, suprahyoid muscle, sensory threshold, pain threshold, saliva flow', 'sensory and pain thresholds', 'saliva flow', 'salivary flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0036677', 'cui_str': 'Sensory threshold'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",20.0,0.0515408,"Results


Significant differences were observed in saliva flow between S1 and S7, as well as S2 and S7 in 75% Stim.
","[{'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Koike', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nozue', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Ihara', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56572']
2182,32913645,The impact of intuitive eating  v . pinned eating on behavioural markers: a preliminary investigation.,"Two promising strategies to manage eating behaviour are intuitive eating (IE; following hunger) and pinned eating (PE; ignoring hunger/eating at specific times of the day). This study compared IE and PE on behavioural markers. Participants ( n  56) were randomly assigned to IE ( n  28) or PE ( n  28) and given instructions to follow for 1 week. Drive to eat, behaviour, behavioural intentions and self-efficacy were measured at baseline and follow-up. Participants also evaluated their specific intervention. Comparable changes over time were found for both conditions for many measures. Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss: those following IE showed an increase in each of these outcomes compared to those following PE who showed no change. The IE group found their intervention more useful than those following PE. Further research is needed to build on these preliminary findings.",2020,"Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss:",['Participants ( n  56'],"['PE', 'intuitive eating  v . pinned eating']","['behavioural markers', 'healthy snacking, total self-efficacy and self-efficacy for weight loss', 'Drive to eat, behaviour, behavioural intentions and self-efficacy']",[],"[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",56.0,0.0331015,"Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss:","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Ogden', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pavlova', 'Affiliation': 'School of Nutrition, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Fouracre', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Lammyman', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}]",Journal of nutritional science,['10.1017/jns.2020.25']
2183,32913759,The effect of positive psychotherapy in test anxiety among Zahedan students with hemophilia.,"Hemophilia is a chronic disease which due to several reasons, including frequent absences from school and reduced motivation, leads to the incident of test anxiety among patients. This study was conducted with the aim of evaluating the effectiveness of positive psychotherapy in test anxiety among students with hemophilia. The current study followed a pretest, posttest, and two-month followup quasi-experimental design with an experimental group and a control group. This study had a statistical population including all senior elementary and junior high school students with hemophilia who had medical records in Zahedan Hemophilia Society. After screening them, 60 students were selected and randomly assigned to two 30-person groups of experimental and control. Since some patients refused to continue taking part in this study, the sample decreased to 57 people. Measurement tool used in this study was Sarason Test Anxiety Scale. Positive psychotherapy was held in 8 sessions (two 120-minute sessions per week) and a follow-up was conducted two months after completing the psychotherapy. Data were analyzed using a repeated measure analysis of variance. Results showed that positive psychotherapy significantly reduced test anxiety among the students with hemophilia. Moreover, the stability of the effects of this therapy in the follow-up was confirmed. The obtained results indicated that policymakers should pay a lot of attention to this new positive psychological training and its effects on reducing test anxiety.",2018,Results showed that positive psychotherapy significantly reduced test anxiety among the students with hemophilia.,"['Zahedan students with hemophilia', 'students with hemophilia', 'statistical population including all senior elementary and junior high school students with hemophilia who had medical records in Zahedan Hemophilia Society', '60 students']","['Positive psychotherapy', 'positive psychotherapy']","['Sarason Test Anxiety Scale', 'test anxiety']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0039577', 'cui_str': 'Test Anxiety Questionnaire'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",60.0,0.0146193,Results showed that positive psychotherapy significantly reduced test anxiety among the students with hemophilia.,"[{'ForeName': 'Mahbobe Ghavidel', 'Initials': 'MG', 'LastName': 'Heydari', 'Affiliation': 'Department of Psychology, Zahedan Branch, Islamic Azad University, Zahedan.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Shirazi', 'Affiliation': 'Department of Psychology, Faculty of Educational Sciences and Psychology, University of Sistan and Baluchestan, Zahedan, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Sanagouyemoharer', 'Affiliation': 'Department of Psychology, Zahedan Branch, Islamic Azad University, Zahedan.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2018.307']
2184,32913773,Metacognitive interpersonal therapy in group: a feasibility study.,"Patients with personality disorders (PDs) other than borderline, with prominent features of social inhibition and over-regulation of emotions, are in need of specialized treatments. Individuals present with poor metacognition, that is the capacity to understand mental states and use psychological knowledge for the sake of purposeful problem solving; and are guided by maladaptive interpersonal schemas. We developed a short-term group intervention, Metacognitive Interpersonal Therapy in Groups (MIT-G), incorporating psychoeducational and experiential elements, to help these individuals become more aware of their drives when interacting with others; and to help them adopt more flexible behaviors via improvements in metacognition. We present results of an effectiveness study, evaluating whether we could replicate the initial positive results of our first pilot randomized controlled trial. Seventeen young adults outpatients with personality disorders were included in the 16 session program. Effect sizes were calculated for change from baseline to treatment end for the primary outcome, symptoms and functioning (Clinical Outcomes in Routine Evaluation Outcome Measure) and then for one putative mechanism of change - metacognition. Emotional dysregulation and alexithymia were also assessed. Qualitative evaluations of the acceptability and subjective impact of the treatment were also performed. MIT-G was acceptable to participants. There were medium to large magnitude changes from pre- to post- treatment on wellbeing, emotion dysregulation, alexithymia and metacognition. These gains were maintained at follow-up. There was evidence of clinically significant change on key variables. MITG appears acceptable to patients, as evidenced by the absence of drop-out from treatment. In light of the positive outcomes of this study and the expanding evidence base, MIT-G is a candidate for dissemination and investigations in larger trials as a possible effective intervention for PDs characterized by tendencies to overcontrol.",2018,"There were medium to large magnitude changes from pre- to post- treatment on wellbeing, emotion dysregulation, alexithymia and metacognition.","['Seventeen young adults outpatients with personality disorders', 'Patients with personality disorders (PDs']","['Metacognitive interpersonal therapy', 'Metacognitive Interpersonal Therapy']","['wellbeing, emotion dysregulation, alexithymia and metacognition', 'Emotional dysregulation and alexithymia']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}]",17.0,0.0709781,"There were medium to large magnitude changes from pre- to post- treatment on wellbeing, emotion dysregulation, alexithymia and metacognition.","[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Popolo', 'Affiliation': 'Centro di Terapia Metacognitiva Interpersonale, Rome, Italy.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'MacBeth', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Brunello', 'Affiliation': 'Servizio Psicologia Clinica DSM, AUSL Modena, Modena, Italy.'}, {'ForeName': 'Flaviano', 'Initials': 'F', 'LastName': 'Canfora', 'Affiliation': 'Servizio Adolescenti CEIS, Modena, Italy.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Ozdemir', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rebecchi', 'Affiliation': 'Servizio Psicologia Clinica DSM, AUSL Modena, Modena, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Toselli', 'Affiliation': 'Villa Igea, Modena, Italy.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Venturelli', 'Affiliation': 'Servizio Psicologia Clinica DSM, AUSL Modena, Modena, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Salvatore', 'Affiliation': 'Centro di Terapia Metacognitiva Interpersonale, Rome, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Dimaggio', 'Affiliation': 'Centro di Terapia Metacognitiva Interpersonale, Rome, Italy.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2018.338']
2185,32913776,"Compassion-focused imagery reduces shame and is moderated by shame, self-reassurance and multisensory imagery vividness.","Compassion-focused imagery (CFI) is an emotion-regulation technique involving visualization of a person, animal or object offering one compassion, to generate feelings of safeness. It is proven to increase self-compassion and reduce negative affect. This study explores two hypotheses not previously investigated: i) which sensory modalities can stimulate compassionate affect; and ii) whether presentation of pictorial stimuli can enhance CFI. Additionally, we examine iii) whether CFI can reduce shame and iv) whether self-criticism inhibits CFI, since previous studies have involved small samples or methodological limitations. After completing measures of self-criticism, selfreassurance and imagery abilities in five sensory modalities, participants (n=160) were randomly assigned to look at compassionate images during CFI (visual input), compassionate images before CFI (priming), or abstract images (control). Participants trialled CFI then rated compassionate affect and completed open-response questions. Before and after CFI, participants recalled a shame-based memory and rated state shame. Correlational analyses explored whether self-criticism, self-reassurance, and multisensory imagery abilities moderated outcomes. CFI significantly reduced shame regarding a recalled memory, particularly for those high in shame. Compassionate affect was predicted by imagery vividness in visual and bodily-sensation modalities. Self-criticism predicted poorer CFI In multiple regressions, self-reassurance predicted poorer CFI outcomes but self-criticism did not. Between-group effects did not emerge. Qualitative data suggested that pictures helped some participants but hindered others. CFI is a promising technique for shame-prone clients, but may be challenging for those with low imagery abilities or unfamiliar with self-reassurance. Multiple senses should be engaged.",2019,"CFI significantly reduced shame regarding a recalled memory, particularly for those high in shame.","['five sensory modalities, participants (n=160']","['look at compassionate images during CFI (visual input), compassionate images before CFI (priming), or abstract images (control', 'CFI', 'Compassion-focused imagery (CFI']","['shame-based memory and rated state shame', 'imagery vividness in visual and bodily-sensation modalities', 'self-criticism, selfreassurance and imagery abilities']","[{'cui': 'C0445254', 'cui_str': 'Sensory'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0055288', 'cui_str': 'Chemotaxis factor inhibitor'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",160.0,0.0254046,"CFI significantly reduced shame regarding a recalled memory, particularly for those high in shame.","[{'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Naismith', 'Affiliation': 'University of Los Andes, Colombia.'}, {'ForeName': 'Camilo Duran', 'Initials': 'CD', 'LastName': 'Ferro', 'Affiliation': 'University of Los Andes, Colombia.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Ingram', 'Affiliation': 'University of Los Andes, Colombia.'}, {'ForeName': 'William Jimenez', 'Initials': 'WJ', 'LastName': 'Leal', 'Affiliation': 'University of Los Andes, Colombia.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.329']
2186,32897013,"[An influence of herbal plant based on the combination of natural terpenes, vitamin and essential oil on the spontaneous stone passage after extracorporeal shock-wave lithotripsy].","INTRODUCTION


There are more than 20 drugs, that are widely used as medical expulsive therapy after extracorporeal shock wave lithotripsy (ESWL). Herbal plants are actively used along with the drug therapy in order to improve the efficiency of the treatment.
PURPOSE OF THE STUDY


to evaluate the efficiency of the drug ""Renotinex"" in patients with kidney stones, as medical expulsive therapy.
MATERIALS AND METHODS


A total of 41 patients with kidney stones who undergone ESWL were included in the study. Patients were divided into two groups of 21 patients. In the main group, patients received the dietary supplement ""Renotinex"" 2 capsules 2 times a day for 1 month, along with standard medical expulsive therapy (NSAIDs [Diclofenac suppositories 50 mg in case of pain] + alpha blockers [Tamsulosin 0.4 mg in the morning for 1 month). The efficiency of treatment was evaluated after 2 and 4 weeks by means of ultrasound and x-ray. A presence and mean size of the stone and dilatation of the collecting system were assessed. In addition, complete blood count (hemoglobin, level of red blood cells and white blood cells), as well as urinalysis (microhematuria and leukocyturia) were performed. For statistical analysis, Student's criterion and the Fishers method were used.
RESULTS


After 2 weeks of treatment, a decrease in the hemoglobin level, number of leukocytes and erythrocytes in urine, as well as a significant decrease in pelvis size and the average size of the urinary stone were seen in the main group. In the control group, there was also a slight decrease in the hemoglobin and a significant increase in the grade of leukocyturia and microhematuria. After 4 weeks, significant intergroup differences were documented in the level of microhematuria, pelvis size and the presence of stone in the collecting system, as confirmed by ultrasound and X-ray study. Stone-free rate in the main group was 47.6%, compared to 20% in the control group.
CONCLUSION


Medical expulsive therapy in combination with dietary supplements ""Renotinex"" after ESWL is more efficient than standard medical expulsive therapy (NSAIDs and -blockers) as monotherapy.",2020,"After 2 weeks of treatment, a decrease in the hemoglobin level, number of leukocytes and erythrocytes in urine, as well as a significant decrease in pelvis size and the average size of the urinary stone were seen in the main group.","['patients with kidney stones, as medical expulsive therapy', '41 patients with kidney stones who undergone ESWL were included in the study']","['natural terpenes, vitamin and essential oil', 'herbal plant', 'extracorporeal shock-wave lithotripsy', 'standard medical expulsive therapy (NSAIDs [Diclofenac suppositories 50 mg in case of pain] + alpha blockers [Tamsulosin']","['spontaneous stone passage', 'hemoglobin level, number of leukocytes and erythrocytes in urine', 'Stone-free rate', 'complete blood count (hemoglobin, level of red blood cells and white blood cells), as well as urinalysis (microhematuria and leukocyturia', 'level of microhematuria, pelvis size and the presence of stone in the collecting system', 'hemoglobin', 'grade of leukocyturia and microhematuria', 'pelvis size and the average size of the urinary stone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0039561', 'cui_str': 'Terpene'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001641', 'cui_str': 'Alpha adrenergic receptor antagonist'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0239937', 'cui_str': 'Microscopic hematuria'}, {'cui': 'C0555120', 'cui_str': 'Urine micr.:leukocytes present'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}]",41.0,0.0185394,"After 2 weeks of treatment, a decrease in the hemoglobin level, number of leukocytes and erythrocytes in urine, as well as a significant decrease in pelvis size and the average size of the urinary stone were seen in the main group.","[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Prosyannikov', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Zolotuhin', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'Yu Yu', 'Initials': 'YY', 'LastName': 'Madykin', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Konstantinova', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Voytko', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Anokhin', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sivkov', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2187,32897014,[Influence of phenazopyridine on the well-being of patients during and after cystoscopy].,"INTRODUCTION


Cystoscopy is one of the most common procedures in urology. There is no single approach to pain relief. In the literature, there are conflicting data on the efficiency of intra-urethral gels. The use of non-steroidal anti-inflammatory drugs, intravenous sedation, and nitric oxide analgesia has been described. Phenazopyridine has been known for a long time. Acting on the bladder mucosa, it has a local analgesic effect. AN evaluation of phenazopyridine intake prior to cystoscopy in order to decrease pain during procedure and facilitate subsequent urination was performed.
MATERIALS AND METHODS


A total of 97 patients were included in the study. Indications for cystoscopy were as following: hematuria, lower urinary tract symptoms/pain, a need to remove ureteral stent. The patients were randomized into two groups. In the main group (n=50), phenazopyridine 200 mg was administered 20 minutes before cystoscopy and then at a dose of 200 mg every 8 hours (in total three doses) in combination with lidocaine gel. In the control group (n=47), only lidocaine gel was used. Heart rate was measured before and after the procedure. All patients were asked to complete a visual analogue scale (VAS) 3, 8 and 24 hours after cystoscopy with the assessment of the first urination.
RESULTS


After cystoscopy, the difference between groups in VAS score was 27.7% in favor of the main group (p<0.001). After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005. The heart rate after the procedure in the main group was 75.1 beats/min, compared to 77.9 beats/min in the control group (p=0.016).
CONCLUSION


The intake of phenazopyridine allows to reduce pain intensity during and after cystoscopy and alleviate pain during first urination.",2020,"After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005.","['patients during and after cystoscopy', 'A total of 97 patients were included in the study']","['lidocaine gel', 'Phenazopyridine', 'phenazopyridine', 'phenazopyridine intake prior to cystoscopy']","['visual analogue scale (VAS', 'proportion of ""zero"" results', 'VAS score', 'pain relief', 'pain intensity', 'Heart rate', 'heart rate', 'average score', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0031379', 'cui_str': 'Phenazopyridine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",97.0,0.0328551,"After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005.","[{'ForeName': 'A Yu', 'Initials': 'AY', 'LastName': 'Tsukanov', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Makushin', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mirzakadiev', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Zolotov', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2188,32897015,[Possibilities of using dietary supplements with antioxidant properties in urinary stone disease].,"INTRODUCTION


Dietary supplements are successfully used in many fields of medicine, including urology. In particular, urologists often prescribe dietary supplements for patients with urolithiasis.
AIM


to study an influence of dietary supplements Nefradoz on the metabolism of the main stone-forming substances and inhibitors of stone formation in patients with urolithiasis.
INTRODUCTION


Dietary supplements are successfully used in many fields of medicine, including urology. In particular, urologists often prescribe dietary supplements for patients with urolithiasis.
AIM


to study an influence of dietary supplements Nefradoz on the metabolism of the main stone-forming substances and inhibitors of stone formation in patients with urolithiasis.
MATERIALS AND METHODS


A total of 60 patients with urinary stone diseases were included in a single-center prospective randomized study. All patients were divided into 2 groups of 30 people, depending on the treatment. In the main group, patients followed standard diet, received general recommendations and dietary supplements Nefradoz for 28-30 days, 1 capsule (150 mg) 2 times a day with meals. In the control group, patients received only general recommendations and followed standard diet therapy for 28-30 days. The blood biochemical profile and 24-hour urine analysis were evaluated, as well as a urinalysis was performed on daily basis.
RESULTS


In patients receiving Nefradoz, urinary uric acid excretion increased by 0.9 mmol/day. It must be emphasized that an increase in uric acid excretion did not exceed the upper normal limit. A tendency towards an increase in urine excretion of sodium (by 54 mmol / day), magnesium (by 1 mmol / day) and citrates (by 0.6 mmol / day) was also found. The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group. Higher urine pH in the main group compared to the control group was also shown. The severity of hematuria with the use of Nefradoz was almost two times lower than in patients who did not receive dietary supplement.
CONCLUSION


Considering our data on the ability of dietary supplement Nefradoz to increase the concentration of main inhibitors of stone formation (magnesium and citrates), Nefradoz can be recommended for patients with urinary stone diseases, especially with concomitant hypomagnesuria and hypocitraturia.",2020,"The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group.","['patients with urolithiasis', '60 patients with urinary stone diseases', 'patients with urinary stone diseases', 'urinary stone disease']","['dietary supplements', 'dietary supplements Nefradoz', 'general recommendations and dietary supplements Nefradoz', 'only general recommendations and followed standard diet therapy']","['blood biochemical profile and 24-hour urine analysis', 'urine excretion of sodium', 'urinary uric acid excretion', 'urine specific gravity', 'Higher urine pH', 'uric acid excretion', 'severity of hematuria with the use of Nefradoz']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042044', 'cui_str': 'Urine pH test'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",60.0,0.0403146,"The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group.","[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Prosiannikov', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Konstantinova', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Golovanov', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Anokhin', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Voitko', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2189,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND


Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS


Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS


There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION


Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
2190,32898690,A nomogram from the SEER database for predicting the prognosis of patients with non-small cell lung cancer.,"OBJECTIVE


The purpose of this study was to establish and validate a nomogram to predict the prognosis in patients with non-small cell lung cancer (NSCLC) from multiple perspectives.
RESULTS


A total of 98,640 eligible patients were randomly divided into a training set (n = 69,048) and a validation set (n = 29,592). The baseline characteristics of the two sets were similar. We used clinical data from patients in the training set for univariate and multivariate Cox regression analyses. Twelve independent risk factors were incorporated for constructed a prognostic nomogram. And the nomogram with a concordance index of 0.777 (95 % CI, 0.775 to 0.779) for overall survival. The calibration curve results showed that the actual survival rate was consistent with the predicted survival rate. The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
CONCLUSION


We have developed a nomogram with high prediction accuracy and discrimination ability, which can help clinicians making personalized survival predictions for NSCLC patients.",2020,"The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
","['98,640 eligible patients', 'NSCLC patients', 'patients with NSCLC', 'patients with non-small cell lung cancer (NSCLC', 'patients with non-small cell lung cancer']",[],"['overall survival rate', 'survival rate', 'actual survival rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",98640.0,0.0901438,"The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
","[{'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Chenzheng', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Anquan', 'Initials': 'A', 'LastName': 'Shang', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Junlu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Zujun', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China. Electronic address: sunzujun@tongji.edu.cn.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China. Electronic address: lidong@tongji.edu.cn.'}]",The international journal of biochemistry & cell biology,['10.1016/j.biocel.2020.105825']
2191,32898698,The benefit of adding lidocaine to ketamine during rapid sequence endotracheal intubation in patients with septic shock: A randomised controlled trial.,"BACKGROUND


Patients with septic shock commonly require endotracheal intubation under general anaesthesia in the operating theatre, the emergency department, and the intensive care unit. Hypotension is a serious complication after induction of general anaesthesia, especially in patients with circulatory failure. No randomised controlled trials had previously investigated protocols for induction of anaesthesia in septic shock patients. The aim of the current work is to compare two protocols, lidocaine-ketamine combination versus ketamine full-dose for rapid-sequence endotracheal intubation in patients with septic shock.
METHODS


Forty-four adult patients, with septic shock, scheduled for emergency surgical intervention were enrolled in this randomised, double-blinded, controlled study. Patients were randomised to receive either 1 mg/kg ketamine (ketamine group, n = 22) or 0.5 mg/kg ketamine plus 1 mg/kg lidocaine (ketamine-lidocaine group, n = 22) for induction of anaesthesia in addition to 0.05 mg/kg midazolam (in both groups). Our primary outcome was the mean arterial pressure (MAP). Other outcomes included frequency of post-induction hypotension, heart rate, and cardiac output.
RESULTS


Forty-three patients were available for final analysis. The average MAP reading in the first 5 min post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}. Furthermore, the incidence of post-intubation hypotension was lower in the ketamine-lidocaine group than in the ketamine group {1 patient (5%) versus 17 patients (77%), P < 0.001}. The ketamine-lidocaine group showed higher MAP in almost all the readings after induction compared to ketamine group. Other haemodynamic variables including cardiac output and heart rate were comparable between both study groups.
CONCLUSION


Lidocaine-ketamine combination showed less incidence of hypotension compared to ketamine full-dose when used for rapid-sequence endotracheal intubation in patients with septic shock. REGISTRATION URL: https://clinicaltrials.gov/ct2/show/NCT03844984?cond=NCT03844984&rank=1.",2020,"The average MAP reading in the first 5 minutes post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}.","['patients with septic shock', 'Patients with septic shock commonly require', 'patients with circulatory failure', 'septic shock patients', 'Forty-four adult patients, with septic shock, scheduled for emergency surgical intervention', 'Patients with Septic Shock']","['ketamine (ketamine group, n\u2009=\u200922) or 0.5\u2009mg/kg ketamine plus 1\u2009mg/kg lidocaine (ketamine-lidocaine group, n\u2009=\u200922) for induction of anaesthesia in addition to 0.05\u2009mg/kg midazolam', 'Ketamine', 'endotracheal intubation', 'ketamine', 'Lidocaine-ketamine', 'lidocaine-ketamine combination versus ketamine', 'ketamine-lidocaine', 'Lidocaine']","['incidence of hypotension', 'mean arterial pressure (MAP', 'cardiac output and heart rate', 'incidence of post-intubation hypotension', 'average MAP reading', 'frequency of post-induction hypotension, heart rate, and cardiac output', 'MAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",44.0,0.561023,"The average MAP reading in the first 5 minutes post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}.","[{'ForeName': 'Shymaa', 'Initials': 'S', 'LastName': 'Fathy', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt. Electronic address: ahmed.hasanin@kasralainy.edu.eg.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ezzat', 'Initials': 'E', 'LastName': 'Ramzy', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Sarhan', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Almenesey', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Safina', 'Affiliation': 'Department of General Surgery, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hosny', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ghada Adel', 'Initials': 'GA', 'LastName': 'Hamden', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Gado', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtar', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Cairo University, Cairo, Egypt.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.06.017']
2192,32899057,Effect of 3 different anticoagulants on hidden blood loss during total hip arthroplasty after tranexamic acid.,"Comparison of different anticoagulants in blood management and complications with tranexamic acid (TXA) in total hip arthroplasty (THA) is unclear. Our aim was to compare the efficacy and safety among receiving nadroparin calcium, enoxaparin sodium or rivaroxaban after TXA in THA.150 patients undergoing primary unilateral THA were received 15 mg/kg intravenous TXA (IV-TXA) before skin incision, followed by 1 of nadroparin calcium (Group A), enoxaparin sodium (Group B), or rivaroxaban (Group C) randomly during hospitalization. The primary outcome was hidden blood loss (HBL). Other outcomes such as the maximum hemoglobin (Hb) drop, total blood loss (TBL), the volume of drainage, transfusion rate, length of hospital stay (LOS), and complications were also compared.There were no statistically significant differences in HBL, the maximum hemoglobin (Hb) drop, transfusion rate, and complications among 3 groups. LOS was significantly higher for patients in Group B than Group A (P = .026). Neither deep venous thrombosis (DVT) nor pulmonary embolism (PE) occurred in any group.There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.",2020,"There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.","['patients undergoing THA receiving', 'THA.150 patients undergoing primary unilateral THA', 'total hip arthroplasty (THA']","['15\u200amg/kg intravenous TXA (IV-TXA) before skin incision, followed by 1 of nadroparin calcium (Group A), enoxaparin sodium (Group B), or rivaroxaban', 'tranexamic acid (TXA', 'tranexamic acid', 'nadroparin calcium, enoxaparin sodium or rivaroxaban', 'nadroparin calcium, enoxaparin sodium, or rivaroxaban']","['maximum hemoglobin (Hb) drop, total blood loss (TBL), the volume of drainage, transfusion rate, length of hospital stay (LOS), and complications', 'efficacy and safety', 'hidden blood loss (HBL', 'hidden blood loss', 'HBL, the maximum hemoglobin (Hb) drop, transfusion rate, and complications', 'deep venous thrombosis (DVT) nor pulmonary embolism (PE', 'LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0724579', 'cui_str': 'Enoxaparin sodium'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}]",,0.0632438,"There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.","[{'ForeName': 'Zeng-Fa', 'Initials': 'ZF', 'LastName': 'Deng', 'Affiliation': ""Department of Joint Surgery, the First Affiliated Hospital, Sun Yat-sen University, GuangZhou, GuangDong Province, People's Republic of China.""}, {'ForeName': 'Zi-Ji', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Pu-Yi', 'Initials': 'PY', 'LastName': 'Sheng', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Ai-Shan', 'Initials': 'AS', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Liao', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022028']
2193,32899069,Effect of acupuncture method of removing-stasisand resuscitating on the consciousness of patients with severe traumatic brain injury: A randomized clinical trial.,"INTRODUCTION


With the development of social economy, transportation and various infrastructures have also developed, but it has objectively increased the number of patients with head injury. Although the current craniocerebral medicine technology continues to advance, long-term bed rest and other complications have led to an insignificant decrease in the mortality rate of coma patients. It is not uncommon for patients with disturbance of consciousness caused by head injury in major hospitals.
METHODS/DESIGN


This will be a retrospective, single-blind clinical observational study. We will select 50 cases that meet the subject's selection criteria. According to whether they received acupuncture treatment or not, they will be randomly divided into 2 groups, namely treatment group and control group. The control group will be given conventional Western medicine treatment, and the treatment group will be given acupuncture method of removing-stasis and resuscitating treatment on the basis of the control group.
DISCUSSION


Our purpose is to observe the role of acupuncture method of removing-stasis and resuscitating in promoting the recovery of patients with severe head injury. We aim to provide more evidence-based medical evidence for acupuncture treatment of this disease.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000034732, Registered on 19 July 2020.",2020,"INTRODUCTION


With the development of social economy, transportation and various infrastructures have also developed, but it has objectively increased the number of patients with head injury.","['patients with severe head injury', 'patients with severe traumatic brain injury', 'patients with disturbance of consciousness caused by head injury in major hospitals', 'patients with head injury']","['conventional Western medicine treatment', 'acupuncture', 'acupuncture method of removing-stasisand resuscitating']",['mortality rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0234428', 'cui_str': 'Disturbance of consciousness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0976505,"INTRODUCTION


With the development of social economy, transportation and various infrastructures have also developed, but it has objectively increased the number of patients with head injury.","[{'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Pan', 'Affiliation': 'Wang Jing Hospital of China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiao-Zhou', 'Initials': 'XZ', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022056']
2194,32899073,The fMRI study for acupuncture on shift work sleep disorder: Study protocol for a randomized controlled neuroimaging trial.,"INTRODUCTION


Nearly 20% of night shift nurses will cause shift work disorder (SWD) due to the disruption of sleep-wake cycle, which not only affects the daily work efficiency, but also brings a huge burden on physical and mental health. Acupuncture is a safe and effective intervention on SWD. This trial will combine with functional magnetic resonance imaging (fMRI) to study the clinical effects and potential mechanism of acupuncture in the treatment of SWD.
METHODS AND ANALYSIS


This is a randomized controlled neuroimaging trial, with enrolled participants, outcome assessors, and data statisticians blinded. 60 patients with SWD and 30 healthy controls who sleep regularly will be recruited and divided into divided into a control group, a true acupoints treatment group (TATG) and a sham acupoints treatment group (SATG) by the ratio of 1:1:1. The TATG and SATG will receive 8 sessions of acupuncture treatment in 4 weeks. Cognitive function scales and MRI scanning will be performed before and after 4-week acupuncture treatment. The control group will receive no intervention. Functional connectivity of intra-network and inter-network will be the primary outcome and effect indicator. The secondary outcomes included Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale. Neuroimage indicators will be correlated with clinical data and scores of cognitive function assessment to explore the possible mechanisms underlying the changes of brain activity caused by acupuncture treatment.
DISCUSSION


The results of this study will enable us to verify the therapeutic effect of acupuncture on SWD and explore the potential central mechanism of acupuncture on SWD from the change of brain activity.",2020,"The secondary outcomes included Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale.",['60 patients with SWD and 30 healthy controls who sleep regularly'],"['Acupuncture', 'acupuncture', 'functional magnetic resonance imaging (fMRI', 'true acupoints treatment group (TATG) and a sham acupoints treatment group (SATG']","['Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087539', 'cui_str': 'Shift work disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]",60.0,0.055346,"The secondary outcomes included Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale.","[{'ForeName': 'Yanzhe', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongfang Hospital affiliated to Beijing University of Chinese Medicine, Beijing100078, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Hongxiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}]",Medicine,['10.1097/MD.0000000000022068']
2195,32899074,What is the optimal regimen for intravenous dexamethasone administration in primary total hip arthroplasty?: A protocol of randomized controlled trial.,"BACKGROUND


A number of recent studies have investigated the optimal dosage and timing of dexamethasone in total hip arthroplasty (THA) but have inconsistent findings. Therefore, we designed the randomized controlled research to look for the optimal intravenous dexamethasone dose for the treatment of early postoperative pain after the THA.
METHODS


The Declaration of Helsinki principles was followed and the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials was adhered in this study. The First Medical Center in People's Liberation Army General Hospital approved the study (2020-089). After written informed consent was obtained, patients aged between 18 and 80 years with Physical Status I to III of American Society of Anesthesiologists, scheduled for primary unilateral THA, were included in this present work. Randomization is the use of a computer-formed list via a secretary, at a ratio of 1:1:1. The major end points were pain scores at 24 hours, 48 hours, and 72 hours after surgery, with visual analog scale (VAS) utilized at rest, and at 45 degrees passive hip flexion. The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay.
RESULTS


We assumed that the patients who received 3 doses of dexamethasone intravenously possessed the best postoperative results compared to those who received 1 or 2 doses of the dexamethasone.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5864).",2020,"The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay.
","['patients aged between 18 and 80 years with Physical Status I to III of American Society of Anesthesiologists, scheduled for primary unilateral THA', 'early postoperative pain after the THA', 'total hip arthroplasty (THA']",['dexamethasone'],"['visual analog scale (VAS', 'total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.183182,"The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay.
","[{'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Liang', 'Affiliation': 'Department of Orthopedics, The First Medical Center in PLA General Hospital, Beijing, 100853, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022070']
2196,32900329,"Cytokine and lipid metabolome effects of low-dose acetylsalicylic acid in critically ill patients with systemic inflammation: a pilot, feasibility, multicentre, randomised, placebo-controlled trial.","OBJECTIVE


The systemic inflammatory response syndrome (SIRS) is a dysregulated response that contributes to critical illness. Adjunctive acetylsalicylic acid (ASA) treatment may offer beneficial effects by increasing the synthesis of specialised proresolving mediators (a subset of polyunsaturated fatty acid-derived lipid mediators).
DESIGN


Pilot, feasibility, multicentre, double-blind, randomised, placebo-controlled trial.
SETTING


Four interdisciplinary intensive care units (ICUs) in Australia.
PARTICIPANTS


Critically ill patients with SIRS.
INTERVENTIONS


ASA 100 mg 12-hourly or placebo, administered within 24 hours of ICU admission and continued until ICU day 7, discharge or death, whichever came first.
MAIN OUTCOME MEASURES


Interleukin-6 (IL-6) serum concentration at 48 hours after randomisation and, in a prespecified subgroup of patients, serum lipid mediator concentrations measured by mass spectrometry.
RESULTS


The trial was discontinued in December 2017 due to slow recruitment and after the inclusion of 48 patients. Compared with placebo, ASA did not decrease IL-6 serum concentration at 48 hours. In the 32 patients with analysis of lipid mediators, low-dose ASA increased the concentration of 15-hydroxyeicosatetraenoic acid, a proresolving precursor of lipoxin A4, and reduced the concentration of the proinflammatory cytochrome P-dependent mediators 17-HETE (hydroxyeicosatetraenoic acid), 18-HETE and 20-HETE. In the eicosapentaenoic acid pathway, ASA significantly increased the concentration of the anti-inflammatory mediators 17,18-DiHETE (dihydroxyeicosatetraenoic acid) and 14,15-DiHETE.
CONCLUSIONS


In ICU patients with SIRS, low-dose ASA did not significantly alter serum IL-6 concentrations, but it did affect plasma concentrations of certain lipid mediators. The ability to measure lipid mediators in clinical samples and to monitor the effect of ASA on their levels unlocks a potential area of biological investigation in critical care.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN 12614001165673).",2020,"In ICU patients with SIRS, low-dose ASA did not significantly alter serum IL-6 concentrations, but it did affect plasma concentrations of certain lipid mediators.","['Four interdisciplinary intensive care units (ICUs) in Australia', 'December 2017 due to slow recruitment and after the inclusion of 48 patients', 'Critically ill patients with SIRS', 'critically ill patients with systemic inflammation']","['low-dose acetylsalicylic acid', 'Adjunctive acetylsalicylic acid (ASA', 'placebo, ASA', 'placebo', 'ASA 100 mg 12-hourly or placebo']","['serum IL-6 concentrations', 'concentration of the anti-inflammatory mediators 17,18-DiHETE (dihydroxyeicosatetraenoic acid) and 14,15-DiHETE', 'Interleukin-6 (IL-6) serum concentration', 'serum lipid mediator concentrations', 'IL-6 serum concentration', 'concentration of 15-hydroxyeicosatetraenoic acid', 'plasma concentrations of certain lipid mediators']","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0020349', 'cui_str': 'Hydroxyeicosatetraenoic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.742564,"In ICU patients with SIRS, low-dose ASA did not significantly alter serum IL-6 concentrations, but it did affect plasma concentrations of certain lipid mediators.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia. luca.cioccari@insel.ch.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Thy', 'Initials': 'T', 'LastName': 'Duong', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'School of Chemistry, Bio21 Molecular Science and Biotechnology Institute, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Salvatore L', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Patryck', 'Initials': 'P', 'LastName': 'Lloyd-Donald', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Peck', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Intensive Care, Bankstown Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Yugeesh R', 'Initials': 'YR', 'LastName': 'Lankadeva', 'Affiliation': 'Preclinical Critical Care Unit, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Gavin E', 'Initials': 'GE', 'LastName': 'Reid', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
2197,32900336,Sodium bicarbonate therapy for metabolic acidosis in critically ill patients: a survey of Australian and New Zealand intensive care clinicians.,"OBJECTIVE


To help shape the design of a future double blind placebo-controlled randomised clinical trial of bicarbonate therapy for metabolic acidosis, based on opinions of intensive care clinicians in Australia and New Zealand.
DESIGN


An online survey was designed, piloted and distributed electronically to members of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) mailing list. The survey sought to collect information about choice of placebo, method of bicarbonate administration, and acid-base monitoring.
MAIN OUTCOME MEASURES


Responses to six questions in the following domains were sought: 1) solution to be used as placebo; 2) method of administration; 3) target of the intervention; 4) timing of arterial blood gases to monitor the intervention; 5) duration of therapy; and 6) rate of bolus therapy (if selected as the best option).
RESULTS


One in every eight ANZICS CTG members completed the survey (118/880, 13.4%). Compound sodium lactate was the preferred solution for placebo (54/118, 45.8%), and continuous infusion of bicarbonate (80/118, 67.8%) was the most frequently selected method of administration. A pH > 7.30 was the preferred target (50/118, 42.4%), while monitoring with arterial blood gas analysis every 2 hours until the target is reached and then every 4 hours was the most favoured option (40/118, 33.9%). The preferred duration of therapy was until the target is achieved (53/118, 44.9%).
CONCLUSIONS


This survey offers important insights into the preferences of Australian and New Zealand clinicians in regards to any future randomised controlled trial of bicarbonate therapy for metabolic acidosis in the critically ill.",2020,"Compound sodium lactate was the preferred solution for placebo (54/118, 45.8%), and continuous infusion of bicarbonate (80/118, 67.8%) was the most frequently selected method of administration.","['intensive care clinicians in Australia and New Zealand', 'critically ill patients']","['Compound sodium lactate', 'bicarbonate therapy', 'Sodium bicarbonate therapy', 'placebo, method of bicarbonate administration, and acid-base monitoring', 'placebo', 'bicarbonate']",['arterial blood gases to monitor the intervention; 5) duration of therapy; and 6) rate of bolus therapy (if selected as the best option'],"[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0142874', 'cui_str': 'Sodium lactate'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1270997', 'cui_str': 'Acid-base balance monitoring'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.238844,"Compound sodium lactate was the preferred solution for placebo (54/118, 45.8%), and continuous infusion of bicarbonate (80/118, 67.8%) was the most frequently selected method of administration.","[{'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia. ary.serpaneto@monash.edu.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'El-Khawas', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Udy', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
2198,32900361,The relationship between the level of μ-opioid receptor (μORs) and postoperative analgesic use in patients undergoing septoplasty: a prospective randomized controlled trial.,"BACKGROUND


In this study, the μ-Opioid receptor activity was assessed pre-operatively for its association with postoperative pain level and second analgesic requirement in patients undergoing septoplasty.
METHODS


In our prospective study, 120 adult patients underwent septoplasty from June 2015 to January 2019 were randomly divided into 2 pre-operative groups. The first group (n = 60) was patients given tramadol (1-2 mg/kg) for post-operative analgesia, and the second group (control group) (n = 60) was initially prescribed only fentanyl (1 μg/ kg-i.v.) in the induction. Acetaminophen with codeine analgesic 325/30 mg (p.o.) was used as an rescue painkiller in the post-operative period. The μ-Opioid receptor activity was investigated in pre-operative blood samples and compared to post-operative pain level and time required for second round of analgesic administration. The visual analogue score (VAS) was used to evaluate the post-operative pain degree (0 no pain; 10 worst pain). The patients' post-operative VAS scores were evaluated upon arrival to recovery room, and at the 1st, 3rd, 7th, 10th, and 24th hour post-operative period.
RESULTS


Demographic data and peri-operative variables were similar in both study group (p < 0.05).There was no significant difference between the receptor levels in both groups and the mean receptor level was 200.94 ± 15.34 pg/mL (max:489.92 ± 22.36 pg/mL, min: 94.56 ± 11.23 pg/mL).In patients who used tramadol as the levels of μ-Opioid receptors increased, VAS scores of patients and second analgesic use decreased in post-operative period.The VAS scores in patients with higher receptor levels were lower in the recovery room (p < 0.05), 1st (p < 0.05) and 3rd hours (p < 0.05).The VAS scores were lower in the tramadol group compared to the control group (p < 0.05).Number of secondary analgesic requirement was significantly lower in patients of the tramadol group with higher receptor levels compared to the ones with lower receptor (p < 0.05) for arrival at the recovery room and 1st hour. Patients in the tramadol group needed a second pain killer much later than patients in the control group.
CONCLUSIONS


Our study demonstrates that patients with higher μOR levels have a higher efficacy of opioid analgesic agents and an lesser need for additional analgesic agents.
TRIAL REGISTRATION


This trial was registered retrospectively (The ACTRN: ACTRN12619001652167 , registration date: 26/11/2019).",2020,(p < 0.05).The VAS scores were lower in the tramadol group compared to the control group (p < 0.05).Number of secondary analgesic requirement was significantly lower in patients of the tramadol group with higher receptor levels compared to the ones with lower receptor (p < 0.05) for arrival at the recovery room and 1st hour.,"['120 adult patients underwent septoplasty from June 2015 to January 2019', 'patients with higher μOR levels', 'patients undergoing septoplasty']","['tramadol', 'Acetaminophen', 'codeine analgesic 325/30']","['receptor levels', 'operative VAS scores', 'μ-Opioid receptor activity', 'mean receptor level', 'VAS scores', 'visual analogue score (VAS']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034801', 'cui_str': 'Opioid Receptor'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.0335004,(p < 0.05).The VAS scores were lower in the tramadol group compared to the control group (p < 0.05).Number of secondary analgesic requirement was significantly lower in patients of the tramadol group with higher receptor levels compared to the ones with lower receptor (p < 0.05) for arrival at the recovery room and 1st hour.,"[{'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Gencer', 'Affiliation': 'Department of Anesthesia, Istinye University Medical Faculty, Istanbul, Turkey. dr.m.gencer07@gmail.com.'}, {'ForeName': 'Ayşe Yeşim', 'Initials': 'AY', 'LastName': 'Göçmen', 'Affiliation': 'Department of Biochemistry, Bozok University Medical Faculty, Yozgat, Turkey.'}]",BMC anesthesiology,['10.1186/s12871-020-01138-z']
2199,32901950,Shorter RSPV cryoapplications result in less phrenic nerve injury and similar 1-year freedom from atrial fibrillation.,"BACKGROUND


In the 123-study, we prospectively assessed, in a randomized fashion, the minimal cryoballoon application time necessary to achieve pulmonary vein (PV) isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) with the aim to reduce complications by shortening the application duration. The first results of this study demonstrated that shortened cryoballoon applications (<2 minutes) resulted in less phrenic nerve injury (PNI) without compromising acute isolation efficacy for the right PVs. We now report the 1-year follow-up results regarding safety and efficacy of shorter cryoballoon applications.
METHODS


A total of 222 patients with AF were randomized to two applications of 1 min ""short,"" 2 min ""medium,"" or 3 min ""long"" duration, 74 per group. Recurrence of AF and PV reconduction at 1-year follow-up were assessed.
RESULTS


The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium, and long application groups (77%, 74%, and 85% for short, medium, and long application groups, respectively; P = 0.07). In 30 patients, a redo PVI procedure was performed. For all four PVs, there was no significant difference in reconduction between the three groups. Reconduction was most common in the left superior PV (57%). The right superior PV (RSPV) showed significantly less reconduction (17%) compared to the other PVs.
CONCLUSIONS


Shortening cryoballoon applications of the RSPV to <2 minutes results in less PNI, while acute success and 1-year freedom from AF are not compromised. Therefore, shorter cryoballoon applications (especially) in the RSPV could be used to reduce PNI.",2020,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","['222 patients with AF', 'patients with paroxysmal atrial fibrillation (AF']",['pulmonary vein (PV) isolation (PVI'],"['overall 1-year freedom from AF', 'reconduction', 'Recurrence of AF and PV reconduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}]",222.0,0.0304896,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","[{'ForeName': 'Marleen M D', 'Initials': 'MMD', 'LastName': 'Molenaar', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hesselink', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Rachel M A', 'Initials': 'RMA', 'LastName': 'Ter Bekke', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Marcoen F', 'Initials': 'MF', 'LastName': 'Scholten', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Manusama', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pison', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kraaier', 'Affiliation': 'Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ten Haken', 'Affiliation': 'Universiteit Twente, Enschede, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Grandjean', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Carl C', 'Initials': 'CC', 'LastName': 'Timmermans', 'Affiliation': 'Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Jurren M', 'Initials': 'JM', 'LastName': 'van Opstal', 'Affiliation': 'Medisch Spectrum Twente, Enschede, The Netherlands.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14062']
2200,32917784,A Randomized Trial on the Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD).,"BACKGROUND


Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain.
METHODS


To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism.
RESULTS


A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m 2 ; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings.
CONCLUSIONS


In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Australian Clinical Trials Registry, ACTRN12610000650099.",2020,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","['278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg', '138 participants received', 'patients with CKD who have normophosphatemia', 'mean age 63.1 years; 69% male, 64% White']","['phosphate-lowering medication', 'lanthanum carbonate or matched placebo', 'non-calcium-based phosphate binders', 'lanthanum', 'Phosphate Reduction', 'placebo']","['mean pulse wave velocity', 'abdominal aortic calcification', 'vascular calcification and arterial stiffness', 'pulse wave velocity', 'fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality', 'abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate', 'Mean serum phosphate', 'Serious adverse events', 'cardiovascular disease', 'arterial stiffness or aortic calcification', 'cardiovascular risk', 'abdominal aortic calcification and serum and urine markers of mineral metabolism', 'Mean eGFR', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0023031', 'cui_str': 'Lanthanum'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",278.0,0.574529,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","[{'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia Nigel.Toussaint@mh.org.au.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Pedagogos', 'Affiliation': 'Department of Medicine, The Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Lioufas', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Grahame J', 'Initials': 'GJ', 'LastName': 'Elder', 'Affiliation': 'School of Medicine, University of Notre Dame, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': 'St. George Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Valks', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Plano, Texas.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cameron', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sylvia S M', 'Initials': 'SSM', 'LastName': 'Chen', 'Affiliation': 'Epworth Healthcare, Melbourne, Victoria, Australia.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Faull', 'Affiliation': 'Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Holt', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Concord Repatriation and General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kerr', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lai-Seong', 'Initials': 'LS', 'LastName': 'Hooi', 'Affiliation': 'Sultanah Aminah Hospital, Johor Bahru, Malaysia.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Narayan', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Angela Yee Moon', 'Initials': 'AYM', 'LastName': 'Wang', 'Affiliation': 'Queen Mary Hospital, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020040411']
2201,32915775,Decreased Synovial Fluid Biomarkers Levels Are Associated with Rehabilitation of Function and Pain in Rotator Cuff Tear Patients Following Electroacupuncture Therapy.,"BACKGROUND The aim of this study was to assess inflammatory cytokines levels in synovial fluid (SF) before and after electroacupuncture (EA) treatment and to explore whether these biomarkers are associated with function of rotator cuff tear (RCT) patients. MATERIAL AND METHODS We recruited 54 patients with RCT and separated them into an EA group and a control group. The SF biomarker levels were detected at baseline and at 6-week and 6-month follow-up. The symptomatic severity was evaluated by visual analog scale (VAS), Constant-Murley score, and American Shoulder and Elbow Surgeons score (ASES). We also investigated the correlation between symptomatic severity and biomarker levels in SF of the shoulder joint. RESULTS The reductions in VAS and improved functional score (ASES and Constant-Murley score) were significantly different between the 2 groups, and SF biomarker concentrations were significantly lower in the EA group. IL-1ß levels were significantly negatively correlated with Constant-Murley score (r=-0.73, P=0.04) and ASES score (r=-0.59, P<0.001) and positively correlated with VAS scores (r=0.81, P=0.004). IL-6 levels were significantly negatively correlated with Constant-Murley score (r=-0.67, P=0.03) and positively correlated with VAS score (r=0.7, P=0.01). MMP-1 levels were significantly negatively correlated with ASES score (r=-0.57, P<0.001). CONCLUSIONS The biomarkers in SF were directly associated with shoulder pain and shoulder function in rotator cuff tear. EA, as a safe and effective conservative therapy, obviously decreased the level of inflammatory cytokines in RCT patients, accompanied by a reduction in shoulder pain and improved function.",2020,"The reductions in VAS and improved functional score (ASES and Constant-Murley score) were significantly different between the 2 groups, and SF biomarker concentrations were significantly lower in the EA group.","['Rotator Cuff Tear Patients Following Electroacupuncture Therapy', '54 patients with RCT and separated them into an EA group and a control group', 'rotator cuff tear (RCT) patients']",['electroacupuncture (EA'],"['Constant-Murley score', 'SF biomarker levels', 'VAS scores', 'ASES score', 'shoulder pain and improved function', 'VAS score', 'SF biomarker concentrations', 'MMP-1 levels', 'visual analog scale (VAS), Constant-Murley score, and American Shoulder and Elbow Surgeons score (ASES', 'IL-1ß levels', 'symptomatic severity', 'level of inflammatory cytokines', 'reductions in VAS and improved functional score (ASES and Constant-Murley score', 'IL-6 levels']","[{'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039097', 'cui_str': 'Synovial fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2001899', 'cui_str': 'MMP1 protein, human'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",54.0,0.0319419,"The reductions in VAS and improved functional score (ASES and Constant-Murley score) were significantly different between the 2 groups, and SF biomarker concentrations were significantly lower in the EA group.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Wei-Qiang', 'Initials': 'WQ', 'LastName': 'Geng', 'Affiliation': ""Department of Orthopedic Surgery, No. 980 Hospital, Joint Logistics Support Force People's Liberation Army (PLA), Handan Campus of Bethune International Hospital, Handan, Hebei, China (mainland).""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Guang-Yuan', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Luo-Bin', 'Initials': 'LB', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'You-Jie', 'Initials': 'YJ', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine Center, First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Orthopedics, Handan Central Hospital, Handan, Hebei, China (mainland).'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine Center, First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China (mainland).'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine Center, First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923240']
2202,32915800,Public stigma towards prolonged grief disorder: Does diagnostic labeling matter?,"The recent introduction of prolonged grief disorder (PGD) as a diagnostic category may cause negative social reactions (i.e. public stigma). Vignette experiments demonstrate that persons with both PGD symptoms and a PGD diagnosis elicit more public stigma than persons who experience integrated grief. However, the strength of the influence of the diagnosis itself remains unclear: We aimed to clarify if the diagnostic label PGD produces additional public stigma beyond PGD symptoms. We further compared whether public stigma varies between the label PGD and the label major depressive episode (MDE) (when PGD symptoms are present) and if gender of the bereaved person influences public stigma or moderates the aforementioned effects. Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief). Following the vignettes, participants indicated which negative characteristics they ascribed to the person, their emotional reactions, and preferred social distance from the person. People with PGD symptoms and PGD (or MDE) diagnosis were attributed more negative characteristics, and elicited more negative emotions and a stronger desire for social distance than people with integrated grief. However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms. Gender of the bereaved only had an influence on desired social distance, which was larger towards men. Helping severely distressed bereaved people (regardless of diagnostic status) cope with negative social reactions may help them adapt to bereavement. Results demonstrate that the experience of severe grief reactions, yet not a diagnostic label per se, causes public stigma.",2020,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","['Public stigma towards prolonged grief disorder', 'persons with both PGD symptoms', 'People with PGD symptoms and PGD (or MDE) diagnosis', 'Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief']",[],"['public stigma', 'severe grief reactions']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}]",852.0,0.0295721,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gonschor', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Maarten C', 'Initials': 'MC', 'LastName': 'Eisma', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Barke', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Doering', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}]",PloS one,['10.1371/journal.pone.0237021']
2203,32915843,Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions.,"We developed a prediction model of long-term risk after percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) based on pre-procedural clinical information. A total of 4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included. Specifically, 1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups. Major adverse cardiac and cardiovascular event (MACCE) was the primary endpoint, including death, stroke, revascularization, and non-fatal myocardial infarction. We assessed the performance of our model using the area under the receiver operating characteristic curve (AUC) and assigned a simplified point-scoring system. One-hundred-thirty-eight (10.8%) patients experienced MACCE in the derivation cohort with hemodialysis (HD: odds ratio [OR] = 2.55), left ventricular ejection fractions (LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72). The AUC of the derivation model was 0.650. The model's performance was similar in the validation cohort (AUC, 0.610). When assigned a point for each associated factor (HD = 3, LVEF <35%, ISO = 2, and DM = 1 point), the average predicted versus the observed MACCE probability using the Japan-CTO extension score for the low, moderate, high, and very high risk groups was 8.1% vs. 7.3%, 16.9% vs. 15.9%, 22.0% vs. 26.1%, and 56.2% vs. 44.4%, respectively. This novel risk model may allow for the estimation of long-term risk and be useful in disseminating appropriate revascularization procedures.",2020,"The model's performance was similar in the validation cohort (AUC, 0.610).","['1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups', 'LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72', '4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included', 'patients with chronic total occlusions']",['percutaneous coronary intervention (PCI'],"['left ventricular ejection fractions', 'death, stroke, revascularization, and non-fatal myocardial infarction', 'observed MACCE probability using the Japan-CTO extension score', 'Major adverse cardiac and cardiovascular event (MACCE', 'coronary chronic total occlusion (CTO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0919560', 'cui_str': 'Stent occlusion'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4139.0,0.0277774,"The model's performance was similar in the validation cohort (AUC, 0.610).","[{'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Muramatsu', 'Affiliation': 'Cardiovascular Center, Tokyo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Kashima', 'Affiliation': 'Division of Cardiology, Sapporo Cardio Vascular Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Okamura', 'Affiliation': 'Division of Cardiology, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Masahisa', 'Initials': 'M', 'LastName': 'Yamane', 'Affiliation': 'Cardiology Department, Saitama Sekishinkai Hospital, Saitama, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Saitama, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Matsuno', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Kijima', 'Affiliation': 'Cardiology and Vascular Medicine, Hoshi General Hospital, Fukushima, Japan.'}, {'ForeName': 'Maoto', 'Initials': 'M', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.'}]",PloS one,['10.1371/journal.pone.0238640']
2204,32915891,Effect of the trajectory of exertional breathlessness on symptom recall and anticipation: A randomized controlled trial.,"BACKGROUND


Breathlessness is a major cause of physical limitation. Recalled breathlessness intensity may differ from experienced intensity and be influenced by the intensity trajectory including the 'peak-end rule'. The primary aim was to test if adding two minutes of low intensity exercise at the end of an exercise test would change the recalled breathlessness. Secondary aims included to analyse the impact of the peak and end exertional breathlessness intensity on breathlessness recall.
METHODS


Randomized controlled trial of 92 adults referred for exercise testing who were randomized (1:1), at test end, to 2 minutes of additional low intensity exercise (intervention; n = 47) or stopping at peak exertion (control; n = 45). Experienced breathlessness during the test and recalled intensity (30 min after the test) was assessed using the Borg CR10 scale.
RESULTS


Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1. There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009). Recalled exertional breathlessness was most strongly related to peak breathlessness (r2 = 0.43). When analyzed together, end breathlessness did not add any explanatory value above that of peak breathlessness.
CONCLUSION


Adding an episode of two minutes of lower exercise and breathlessness intensity at the end of an exercise test did not affect symptom recall, which was most strongly related to peak breathlessness intensity.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03468205).",2020,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","['92 adults referred for exercise testing', 'Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1']","['low intensity exercise', 'additional low intensity exercise (intervention; n = 47) or stopping at peak exertion']","['symptom recall and anticipation', 'peak breathlessness', 'recalled breathlessness intensity', 'Recalled breathlessness intensity', 'end breathlessness', 'Experienced breathlessness', 'Recalled exertional breathlessness', 'peak and end exertional breathlessness intensity on breathlessness recall']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444930', 'cui_str': 'End'}]",92.0,0.194385,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Elmberg', 'Affiliation': 'Department of Clinical Physiology, Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'Department of Clinical Sciences Lund, Respiratory Medicine and Allergology, Faculty of Medicine, Lund University, Lund, Sweden.'}]",PloS one,['10.1371/journal.pone.0238937']
2205,32900856,Nurse practitioner administered point-of-care ultrasound compared with X-ray for children with clinically non-angulated distal forearm fractures in the ED: a diagnostic study.,"BACKGROUND


Paediatric distal forearm fractures are a common ED presentation. They can be diagnosed with point-of-care ultrasound (POCUS) as an alternative to X-rays. Given that ED nurse practitioners (NPs) are relied on for the diagnosis of paediatric fractures, it is important to describe the diagnostic accuracy of NP-conducted POCUS versus X-ray.
METHODS


This prospective diagnostic study was conducted in a tertiary paediatric hospital in Queensland, Australia, between February 2018 and April 2019. Participants were children aged 4-16 years with a clinically non-angulated, suspected distal forearm fracture. Diagnosis from 6-view NP-administered POCUS of the distal radius and ulna was compared against the reference standard of 2-view X-ray. Each patient received both imaging modalities. Overall forearm diagnosis was classified as 'no', 'buckle' or 'other' fracture for both modalities. The primary outcome was diagnostic accuracy for 'any' fracture ('buckle' and 'other' fractures combined). Secondary outcomes included diagnostic accuracy for 'other' fractures versus 'buckle' and 'no' fractures combined, and pain, imaging duration and preference for modality.
RESULTS


Of 204 recruited patients, 129 had X-ray-diagnosed forearm fractures. The sensitivity and specificity for NP-administered POCUS were 94.6% (95% CI 89.2% to 97.3%) and 85.3% (95% CI 75.6% to 91.6%), respectively. 'Other' fractures (mostly cortical breach fractures), when compared with 'buckle'/ 'no' fractures, had sensitivity 81.0% (95% CI 69.1% to 89.1%) and specificity 95.9% (95% CI 91.3% to 98.1%). Pain and imaging duration were clinically similar between modalities. There was a preference for POCUS by patients, parents and NPs.
CONCLUSIONS


NP-administered POCUS had clinically acceptable diagnostic accuracy for paediatric patients presenting with non-angulated distal forearm injuries. This included good sensitivity for diagnosis of 'any' fracture and good specificity for diagnosis of cortical breach fractures alone. Given the preference for POCUS, and the lack of difference in pain and duration between modalities, future research should consider functional outcomes comparing POCUS with X-ray in this population in a randomised controlled trial.",2020,"CONCLUSIONS


NP-administered POCUS had clinically acceptable diagnostic accuracy for paediatric patients presenting with non-angulated distal forearm injuries.","['children with clinically non-angulated distal forearm fractures in the ED', '204 recruited patients, 129 had X-ray-diagnosed forearm fractures', 'Participants were children aged 4-16 years with a clinically non-angulated, suspected distal forearm fracture', 'paediatric patients presenting with non-angulated distal forearm injuries', 'tertiary paediatric hospital in Queensland, Australia, between February 2018 and April 2019']","['Nurse practitioner administered point-of-care ultrasound compared with X-ray', 'NP-administered POCUS']","['Overall forearm diagnosis', 'Pain and imaging duration', 'diagnostic accuracy', ""diagnostic accuracy for 'other' fractures versus 'buckle' and 'no' fractures combined, and pain, imaging duration and preference for modality"", ""diagnostic accuracy for 'any' fracture ('buckle' and 'other' fractures combined"", 'sensitivity and specificity for NP-administered POCUS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1305215', 'cui_str': 'Fracture of forearm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0016537', 'cui_str': 'Injury of forearm'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",204.0,0.0717416,"CONCLUSIONS


NP-administered POCUS had clinically acceptable diagnostic accuracy for paediatric patients presenting with non-angulated distal forearm injuries.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snelling', 'Affiliation': 'School of Medicine, Griffith University Faculty of Health, Southport, Queensland, Australia peter.snelling@health.qld.gov.au.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': ""Emergency and Trauma Centre, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Keijzers', 'Affiliation': 'School of Medicine, Griffith University Faculty of Health, Southport, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bade', 'Affiliation': ""Department of Orthopaedics, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Herd', 'Affiliation': ""Department of Emergency Medicine, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2020-209689']
2206,32902390,"Age and Attitudes Towards an Internet-Mediated, Pedometer-Based Physical Activity Intervention for Chronic Obstructive Pulmonary Disease: Secondary Analysis.","BACKGROUND


Chronic obstructive pulmonary disease (COPD) is prevalent among older adults. Promoting physical activity and increasing exercise capacity are recommended for all individuals with COPD. Pulmonary rehabilitation is the standard of care to improve exercise capacity, although there are barriers that hinder accessibility. Technology has the potential to overcome some of these barriers, but it is unclear how aging adults with a chronic disease like COPD perceive technology-based platforms to support their disease self-management.
OBJECTIVE


Guided by the unified theory of acceptance and use of technology, the current retrospective secondary analysis explores if age moderates multiple factors that influence an individual with COPD's openness toward an internet-mediated, pedometer-based physical activity intervention.
METHODS


As part of an efficacy study, participants with COPD (N=59) were randomly assigned to use an internet-mediated, pedometer-based physical activity intervention for 12 weeks. At completion, they were asked about their experience with the intervention using a survey, including their performance expectancy and effort expectancy, facilitating conditions (ie, internet use frequency and ability), and use of the intervention technology. Logistic regression and general linear modeling examined the associations between age and these factors.
RESULTS


Participants ranged in age from 49 to 89 years (mean 68.66, SD 8.93). Disease severity was measured by forced expiratory volume in the first second percent predicted (mean 60.01, SD 20.86). Nearly all participants (54/59) believed the intervention was useful. Regarding effort expectancy, increasing age was associated with reporting that it was easy to find the time to engage in the intervention. Regarding facilitating conditions, approximately half of the participants believed the automated step count goals were too high (23/59) and many did not feel comfortable reaching their goals (22/59). The probability of these perceptions increased with age, even after accounting for disease severity. Age was not associated with other facilitating conditions or use of the technology.
CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention. Age is associated with certain expectations of effort and facilitating conditions. Consideration of age of the user is needed when personalizing step count goals and time needed to log in to the website.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01772082; https://clinicaltrials.gov/ct2/show/NCT01772082.",2020,"CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention.","['older adults', 'Chronic Obstructive Pulmonary Disease', 'Chronic obstructive pulmonary disease (COPD', 'Participants ranged in age from 49 to 89 years (mean 68.66, SD 8.93', 'individuals with COPD', 'participants with COPD (N=59']","['internet-mediated, pedometer-based physical activity intervention', 'Pedometer-Based Physical Activity Intervention']","['Age and Attitudes', 'forced expiratory volume', 'Disease severity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0549655,"CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention.","[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Robinson', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, United States.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Wan', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, Veterans Affairs Boston Healthcare System, Boston, MA, United States.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shimada', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, United States.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, Veterans Affairs Boston Healthcare System, Boston, MA, United States.'}]",JMIR aging,['10.2196/19527']
2207,32913797,Psychological and physiological effects of emotion focused training for self-compassion and self-protection.,"Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP) is a novel intervention developed on the basis of the latest findings on self-criticism from Emotion-focused therapy and existing programs designed to cultivate compassion. EFTSCP is designed to encourage participants to cultivate self-compassion and protective anger as a way of reducing selfcriticism. Our goal was to investigate the effect of this group-based intervention on self-criticism, self-protection, and self-compassion. A total of 73 students were assigned to the EFT-SCP intervention ( n =19), no-treatment control ( n =34) or to an active control group ( n =20). The intervention group met weekly for 1.5 hours and were instructed to incorporate EFT-SCP tasks into their daily life for 12 weeks. Whilst the no-treatment group did not undergo an intervention, the active control group completed an adapted expressive writing task once a week. In addition to the assessment of heart rate variability during imagery tasks, participants also completed self-reported measures of self-compassion and self-criticism before and after the intervention. Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017; .34 and Inadequate Self P<.001; .33) and self-uncompassionate responding (P<.001; .39). All three effect sizes were small. Participating in EFT-SCP had a positive effect on psychological and physiological outcomes.",2019,"Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017;",['A total of 73 students'],"['EFT-SCP intervention', 'EFTSCP', 'EFT-SCP tasks', 'Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP']","['selfcriticism', 'self-criticism, self-protection, and self-compassion', 'self-compassion and self-criticism', 'heart rate variability', 'heart rate variability following EFT-SCP']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",73.0,0.0216659,"Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017;","[{'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Halamová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Koróniová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kanovský', 'Affiliation': 'Institute of Social Anthropology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Mária Kénesy', 'Initials': 'MK', 'LastName': 'Túniyová', 'Affiliation': 'Institute of Experimental Psychology, Center of Social and Psychological Sciences, Slovak Academy of Sciences, Bratislava, Slovakia.'}, {'ForeName': 'Nuriye', 'Initials': 'N', 'LastName': 'Kupeli', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, United Kingdom.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.358']
2208,32913807,Reductions in transdiagnostic factors as the potential mechanisms of change in treatment outcomes in the Unified Protocol: a randomized clinical trial.,"Transdiagnostic approaches emphasize on the share underlying features of emotional disorders. In their view, these transdiagnostic factors play an important role in the etiology, maintenance, and treatment of emotional disorders. This study aimed to investigate the transdiagnostic factors as the potential mechanisms of change in the Unified Protocol (UP) for the transdiagnostic treatment of emotional disorders outcomes. The present study is a randomized clinical trial. Twenty-six individuals were selected based on the Beck anxiety inventory and Beck depression inventory and randomly assigned into two groups of control and treatment (n=13). The treatment group received 20 one-hour individual UP sessions. Beck Depression Inventory, Beck Anxiety Inventory, Difficulty in emotion regulation scale, Intolerance of Uncertainty scale and Acceptance and Action questionnaire were carried out in all three phases. UP enhances the difficulty in emotion regulation (large effect size, SEsg=1.81), intolerance of uncertainty (SEsg=1.91), and experiential avoidance (SEsg=1.78). In addition, the results of linear regression show the association between changes in anxiety and depression with changes in transdiagnostic factors. The difficulty in emotion regulation, intolerance of uncertainty and experiential avoidance can be considered as the potential mechanism of change in improving UP outcomes.",2019,"UP enhances the difficulty in emotion regulation (large effect size, SEsg=1.81), intolerance of uncertainty (SEsg=1.91), and experiential avoidance (SEsg=1.78).",['Twenty-six individuals were selected based on the Beck anxiety inventory and Beck depression inventory and randomly assigned into two groups of control and treatment (n=13'],['20 one-hour individual UP sessions'],"['Beck Depression Inventory, Beck Anxiety Inventory, Difficulty in emotion regulation scale, Intolerance of Uncertainty scale and Acceptance and Action questionnaire', 'difficulty in emotion regulation']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",26.0,0.021658,"UP enhances the difficulty in emotion regulation (large effect size, SEsg=1.81), intolerance of uncertainty (SEsg=1.91), and experiential avoidance (SEsg=1.78).","[{'ForeName': 'Sahel', 'Initials': 'S', 'LastName': 'Khakpoor', 'Affiliation': 'Master of Clinical Psychology, Education and Treatment Center of Beheshti Hospital, Zanjan University of Medical Sciences, Zanjan.'}, {'ForeName': 'Jahangir', 'Initials': 'J', 'LastName': 'Mohammadi Bytamar', 'Affiliation': 'Master of Clinical Psychology, Education and Treatment Center of Valiasr Hospital, Zanjan University of Medical Sciences, Zanjan.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Saed', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.379']
2209,32913843,"Effect of a 12-week training program on the anthropometric and physiological profiles of some participants registered in a fitness center in Douala, Cameroon.","Fitness centers are remarkably abundant in Cameroon. The aim of this work was to assess the effects of a 12-week training program on the anthropometric and physiological profiles of some participants in a fitness center. A total of 86 participants (40 from the experimental group and 46 from the control group) with age ranging from 17 to 53 years were subjected to pre- and posttraining assessments of, anthropometric parameters, physiological parameters, and performance. Anthropometric parameters (weight, height, body mass index [BMI], waist circumference [WC]) and blood pressure (diastolic blood pressure, systolic blood pressure [SBP]) were measured according to standard protocols. Heart rate was recorded using a heart rate monitor. Cardiorespiratory fitness (maximal oxygen uptake or VO 2peak ) was estimated by the 20-multistage shuttle run test. All the data was collected twice within 12 weeks. Weight, BMI, and WC did not show any significant variation ( P >0.05) after a 12-week training program. VO 2peak  increase was insignificant ( P >0.05) higher in men (7.5%,  P =0.06), compared to women (5.4%,  P =0.4). We noticed a significant reduction ( P =0.002) in the SBP of men. Significant increase of HR max was found in women. There was an improvement of 13.7% in the VO 2peak  of the participants who did not consume alcohol. These results demonstrate the slight benefits of a 12-week training program on health. The weight characteristics of the participants and lifestyle may play an important role in these interactions.",2020,"VO 2peak  increase was insignificant ( P >0.05) higher in men (7.5%,  P =0.06), compared to women (5.4%,  P =0.4).","['participants registered in a fitness center in Douala, Cameroon', 'some participants in a fitness center', '86 participants (40 from the experimental group and 46 from the control group) with age ranging from 17 to 53 years']",['training program'],"['Anthropometric parameters (weight, height, body mass index [BMI], waist circumference [WC]) and blood pressure (diastolic blood pressure, systolic blood pressure [SBP', 'Heart rate', 'HR max', 'Weight, BMI, and WC', 'Cardiorespiratory fitness (maximal oxygen uptake or VO 2peak ']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C0574438', 'cui_str': 'Duala language'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",86.0,0.0139777,"VO 2peak  increase was insignificant ( P >0.05) higher in men (7.5%,  P =0.06), compared to women (5.4%,  P =0.4).","[{'ForeName': 'Peguy Brice Assomo', 'Initials': 'PBA', 'LastName': 'Ndemba', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Clarisse Noël Ayina', 'Initials': 'CNA', 'LastName': 'Ayina', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Wiliam Richard', 'Initials': 'WR', 'LastName': 'Guessogo', 'Affiliation': 'National Institute of Youth and Sports of Yaounde, Yaounde, Cameroon.'}, {'ForeName': 'Jerson Mekoulou', 'Initials': 'JM', 'LastName': 'Ndongo', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Rita Ornella Ghontchouang', 'Initials': 'ROG', 'LastName': 'Kamnang', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Claude Elysée Bika', 'Initials': 'CEB', 'LastName': 'Lele', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Samuel Honoré', 'Initials': 'SH', 'LastName': 'Mandengue', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Laurent Serge', 'Initials': 'LS', 'LastName': 'Etoundi-Ngoa', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Biomedical Sciences, University of Yaounde I, Yaounde, Cameroon.'}, {'ForeName': 'Abdou', 'Initials': 'A', 'LastName': 'Temfemo', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}]",Journal of exercise rehabilitation,['10.12965/jer.2040340.170']
2210,32913993,Exploratory Analysis of Single-Gene Predictive Biomarkers in HERA DASL Cohort Reveals That C8A mRNA Expression Is Prognostic of Outcome and Predictive of Benefit of Trastuzumab.,"Purpose


The Herceptin Adjuvant study is an international multicenter randomized trial that compared 1 or 2 years of trastuzumab given every 3 weeks with observation in women with human epidermal growth factor 2-positive (HER2+) breast cancer after chemotherapy. Identification of biomarkers predictive of a benefit from trastuzumab will minimize overtreatment and lower health care costs.
Methods


To identify possible single-gene biomarkers, an exploratory analysis of 3,669 gene probes not expected to be expressed in normal breast tissue was conducted. Disease-free survival (DFS) was used as the end point in a Cox regression model, with the interaction term between C8A mRNA and treatment as a categorical variable split on the cohort mean.
Results


A significant interaction between C8A mRNA and treatment was detected ( P  < .001), indicating a predictive response to trastuzumab treatment. For the C8A-low subgroup (mRNA expression lower than the cohort mean), no significant treatment benefit was observed ( P  = .73). In the C8A-high subgroup, patients receiving trastuzumab experienced a lower hazard of a DFS event by approximately 75% compared with those in the observation arm (hazard ratio [HR], 0.25;  P  < .001). A significant prognostic effect of C8A mRNA also was seen ( P  < .001) in the observation arm, where the C8A-high group hazard of a DFS event was three times the respective hazard of the C8A-low group (HR, 3.27;  P  < .001). C8A mRNA is highly prognostic in the Hungarian Academy of Science HER2+ gastric cancer cohort (HR, 1.72;  P  < .001).
Conclusion


C8A as a single-gene biomarker prognostic of DFS and predictive of a benefit from trastuzumab has the potential to improve the standard of care in HER2+ breast cancer if validated by additional studies. Understanding the advantage of overexpression of C8A related to the innate immune response can give insight into the mechanisms that drive cancer.",2018,"A significant prognostic effect of C8A mRNA also was seen ( P  < .001) in the observation arm, where the C8A-high group hazard of a DFS event was three times the respective hazard of the C8A-low group (HR, 3.27;  P  < .001).",['women with human epidermal growth factor 2-positive (HER2+) breast cancer after chemotherapy'],"['trastuzumab', 'C8A mRNA']","['DFS event', 'Disease-free survival (DFS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0398766,"A significant prognostic effect of C8A mRNA also was seen ( P  < .001) in the observation arm, where the C8A-high group hazard of a DFS event was three times the respective hazard of the C8A-low group (HR, 3.27;  P  < .001).","[{'ForeName': 'Scooter', 'Initials': 'S', 'LastName': 'Willis', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Varvara', 'Initials': 'V', 'LastName': 'Polydoropoulou', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Tsourti', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Karlis', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Long', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Theel', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Carlson', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Győrffy', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abramovitz', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leyland-Jones', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}]",JCO precision oncology,['10.1200/PO.18.00016']
2211,32914010,Genomic Instability and  TP53  Genomic Alterations Associate With Poor Antiproliferative Response and Intrinsic Resistance to Aromatase Inhibitor Treatment.,"PURPOSE


Although aromatase inhibitor (AI) treatment is effective in estrogen receptor-positive postmenopausal breast cancer, resistance is common and incompletely explained. Genomic instability, as measured by somatic copy number alterations (SCNAs), is important in breast cancer development and prognosis. SCNAs to specific genes may drive intrinsic resistance, or high genomic instability may drive tumor heterogeneity, which allows differential response across tumors and surviving cells to evolve resistance to treatment rapidly. We therefore evaluated the relationship between SCNAs and intrinsic resistance to treatment as measured by a poor antiproliferative response.
PATIENTS AND METHODS


SCNAs were determined by single nucleotide polymorphism array in baseline and surgery core-cuts from 73 postmenopausal patients randomly assigned to receive 2 weeks of preoperative AI or no AI in the Perioperative Endocrine Therapy-Individualizing Care (POETIC) trial. Fifty-six samples from the AI group included 28 poor responders (PrRs, less than 60% reduction in protein encoded by the  MKI67  gene [Ki-67]) and 28 good responders (GdRs, greater than 75% reduction in Ki-67). Exome sequencing was available for 72 pairs of samples.
RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048). The SCNA with the largest difference between GdRs and PrRs was loss of heterozygosity observed at 17p (false discovery rate, 0.08), which includes  TP53.  Nine of 28 PrRs had loss of wild-type  TP53  as a result of mutations and loss of heterozygosity compared with three of 28 GdRs. In PrRs, somatic alterations of  TP53  were associated with higher genomic instability, higher baseline Ki-67, and greater resistance to AI treatment compared with wild-type  TP53 .
CONCLUSION


We observed that primary tumors with high genomic instability have an intrinsic resistance to AI treatment and do not require additional evolution to develop resistance to estrogen deprivation therapy.",2019,"RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048).",['SCNAs were determined by single nucleotide polymorphism array in baseline and surgery core-cuts from 73 postmenopausal patients'],"['preoperative AI or no AI in the Perioperative Endocrine Therapy-Individualizing Care', 'aromatase inhibitor (AI) treatment']","['Ki-67 expression', 'heterozygosity']","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}]",73.0,0.0322576,"RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048).","[{'ForeName': 'Eugene F', 'Initials': 'EF', 'LastName': 'Schuster', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Gellert', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Corrinne V', 'Initials': 'CV', 'LastName': 'Segal', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'López-Knowles', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Buus', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Maggie Chon U', 'Initials': 'MCU', 'LastName': 'Cheang', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morden', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCO precision oncology,['10.1200/PO.18.00286']
2212,32907566,"Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator.","BACKGROUND


Navafenterol (AZD8871) is a dual-pharmacology muscarinic antagonist β 2- agonist (MABA) molecule in development for the treatment of chronic obstructive pulmonary disease (COPD). The pharmacodynamics, safety and tolerability of single doses of navafenterol were investigated in patients with moderate to severe COPD.
METHODS


This was a randomized, five-way complete cross-over study. Patients received single doses of navafenterol 400 μg, navafenterol 1800 μg and placebo (all double-blind) and indacaterol 150 μg and tiotropium 18 μg (both open-label active comparators). The primary pharmacodynamic endpoint was change from baseline in trough forced expiratory volume in 1 s (FEV 1 ) on day 2. Safety and tolerability were monitored throughout.
RESULTS


Thirty-eight patients were randomized and 28 (73.7%) completed the study. Navafenterol 400 μg and 1800 μg demonstrated statistically significant improvements vs placebo in change from baseline in trough FEV 1  (least squares mean [95% confidence interval]: 0.111 [0.059, 0.163] L and 0.210 [0.156, 0.264] L, respectively, both P < .0001). The changes were significantly greater with navafenterol 1800 μg vs the active comparators (least squares mean treatment difference: 0.065-0.069 L, both P < .05). The frequency of treatment-emergent adverse events was similar for placebo and the active comparators (range 34.4-37.5%), slightly higher for navafenterol 400 μg (52.9%), and lowest for navafenterol 1800 μg (22.6%).
CONCLUSIONS


Both doses of navafenterol demonstrated sustained bronchodilation over 24 h. Navafenterol was well tolerated and no safety concerns were raised.
TRIAL REGISTRY


ClinicalTrials.gov ; No.: NCT02573155 ; URL: www.clinicaltrials.gov . Registered 9th October, 2015.",2020,"Navafenterol 400 μg and 1800 μg demonstrated statistically significant improvements vs placebo in change from baseline in trough FEV 1  (least squares mean [95% confidence interval]: 0.111 [0.059, 0.163] L and 0.210 [0.156, 0.264] L, respectively, both P < .0001).","['Thirty-eight patients were randomized and 28 (73.7%) completed the study', 'chronic obstructive pulmonary disease (COPD', 'patients with moderate to severe COPD', 'patients with COPD']","['navafenterol', 'navafenterol 400\u2009μg, navafenterol 1800\u2009μg and placebo', 'placebo', 'indacaterol 150\u2009μg and tiotropium 18\u2009μg (both open-label active comparators', 'Navafenterol', 'Navafenterol (AZD8871']","['tolerated and no safety concerns', 'Safety and tolerability', 'trough forced expiratory volume in 1\u2009s (FEV 1 ) on day 2', 'pharmacodynamics, safety and tolerability', 'frequency of treatment-emergent adverse events']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",38.0,0.72429,"Navafenterol 400 μg and 1800 μg demonstrated statistically significant improvements vs placebo in change from baseline in trough FEV 1  (least squares mean [95% confidence interval]: 0.111 [0.059, 0.163] L and 0.210 [0.156, 0.264] L, respectively, both P < .0001).","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Medicines Evaluation Unit, Centre for Respiratory and Allergy Medicine, University of Manchester, University Hospital of South Manchester NHS Foundation Trust, M23 9QZ, Manchester, UK. dsingh@meu.org.uk.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Balaguer', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Astbury', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby-Hamrén', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Seoane', 'Affiliation': 'Biometrics and Information Sciences, Late-Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Villarroel', 'Affiliation': 'Late-Stage Development, BioPharmaceuticals R&D; AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Alejhandra', 'Initials': 'A', 'LastName': 'Lei', 'Affiliation': 'Patient Safety RIA, Chief Medical Office, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Respiratory research,['10.1186/s12931-020-01347-7']
2213,32907573,Evaluation of a novel intervention to reduce burnout in doctors-in-training using self-care and digital wellbeing strategies: a mixed-methods pilot.,"BACKGROUND


Burnout for doctors-in-training is increasingly cause for concern. Our objectives were to assess the feasibility, acceptability and impact of a novel intervention to reduce burnout and improve wellbeing. This is the first wellbeing intervention for medical doctors to include strategies for work-life boundary management and digital wellbeing.
METHODS


Twenty-two doctors participated in face-to-face workshops which included group discussion of challenges experienced and strategies to enhance self-care and wellbeing. A pre-post-test mixed-methods evaluation was undertaken. Questionnaire measures were the Oldenburg Burnout Inventory, Warwick-Edinburgh Mental Wellbeing Scale and the boundary control subscale of the Work-Life Indicator (i.e., the degree of perception of control of the boundaries between work and personal life). Paired t-tests examined whether there were statistically significant differences. Eleven doctors also participated in post-intervention semi-structured interviews. Transcripts were analysed using thematic analysis.
RESULTS


The intervention was well-received, with all trainees finding the workshop useful and saying they would recommend it to others. At baseline most participants had scores indicative of burnout on both the disengagement (82%) and exhaustion (82%) subscales of the Oldenburg Burnout Inventory. One month post-intervention, participants had a statistically significant reduction in burnout (both disengagement and exhaustion) and improvement in boundary control. Wellbeing scores also improved, but differences were not statistically significant. Qualitative analysis indicated participants had welcomed a safe space to discuss stressors and many had implemented digital wellbeing strategies to manage their smartphone technology, and increased self-care such as mindfulness practice and walking in green space.
CONCLUSIONS


The intervention reduced burnout and improved boundary control. We suggest that having protected time for doctors to share personal experiences, adopt digital wellbeing and self-care strategies are effective tools to support doctors' wellbeing and should be investigated further.",2020,"One month post-intervention, participants had a statistically significant reduction in burnout (both disengagement and exhaustion) and improvement in boundary control.","['Twenty-two doctors participated in face-to-face workshops which included group discussion of challenges experienced and strategies to enhance self-care and wellbeing', 'Eleven doctors also participated in post-intervention semi-structured interviews']",['novel intervention'],"['Wellbeing scores', 'boundary control', 'degree of perception of control of the boundaries between work and personal life', 'Oldenburg Burnout Inventory, Warwick-Edinburgh Mental Wellbeing Scale and the boundary control subscale of the Work-Life Indicator']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",22.0,0.0285969,"One month post-intervention, participants had a statistically significant reduction in burnout (both disengagement and exhaustion) and improvement in boundary control.","[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Rich', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Marta E', 'Initials': 'ME', 'LastName': 'Cecchinato', 'Affiliation': 'Computer and Information Sciences Department, Northumbria University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lascau', 'Affiliation': 'UCL Interaction Centre, University College London, London, UK.'}, {'ForeName': 'Magdalen', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Viney', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Cox', 'Affiliation': 'UCL Interaction Centre, University College London, London, UK. anna.cox@ucl.ac.uk.'}]",BMC medical education,['10.1186/s12909-020-02160-y']
2214,32907575,"Navafenterol (AZD8871) in healthy volunteers: safety, tolerability and pharmacokinetics of multiple ascending doses of this novel inhaled, long-acting, dual-pharmacology bronchodilator, in two phase I, randomised, single-blind, placebo-controlled studies.","BACKGROUND


Navafenterol (AZD8871) is a novel, long-acting, dual-pharmacology (muscarinic receptor antagonist and β 2- adrenoceptor agonist) molecule in development for chronic obstructive pulmonary disease and asthma.
METHODS


These two phase I, randomised, single-blind, multiple-ascending-dose studies evaluated inhaled navafenterol and placebo (3:1 ratio) in healthy, male, non-Japanese (study A; NCT02814656) and Japanese (study B; NCT03159442) volunteers. In each study, volunteers were dosed in three cohorts, allowing gradual dose escalation from 300 μg to 600 μg to 900 μg. The primary objective was to investigate the safety and tolerability of navafenterol at steady state. Pharmacokinetics were also assessed.
RESULTS


Twenty-four volunteers completed each study (navafenterol, n = 6; placebo, n = 2 in each cohort). There were no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol. The most frequent TEAEs were vessel puncture-site bruise (placebo, n = 2; navafenterol 900 μg; n = 3) in study A and diarrhoea (placebo, n = 1; navafenterol 300 μg, n = 2; navafenterol 900 μg, n = 3) in study B. No dose-response relationship was observed for TEAEs. There was a dose-dependent increase in mean heart rate on day 16 in both studies. The pharmacokinetics of navafenterol were similar between non-Japanese and Japanese volunteers.
CONCLUSIONS


Multiple ascending doses of navafenterol were well-tolerated and the safety and pharmacokinetics of navafenterol were similar in non-Japanese and Japanese volunteers. The findings support navafenterol clinical development.
TRIAL REGISTRATION


ClinicalTrials.gov ; Nos.: NCT02814656 and NCT03159442; URL: www.clinicaltrials.gov .",2020,"There were no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol.","['Twenty-four volunteers completed each study (navafenterol, n\u2009=\u20096; placebo, n\u2009=\u20092 in each cohort', '3:1 ratio) in healthy, male, non-Japanese (study A; NCT02814656) and Japanese (study B; NCT03159442) volunteers', 'healthy volunteers']","['diarrhoea (placebo, n\u2009=\u20091; navafenterol 300\u2009μg, n\u2009=\u20092; navafenterol', 'placebo', 'inhaled navafenterol and placebo', 'Navafenterol (AZD8871']","['no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol', 'safety, tolerability and pharmacokinetics', 'safety and tolerability', 'mean heart rate', 'safety and pharmacokinetics of navafenterol', 'vessel puncture-site bruise']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1535879', 'cui_str': 'Vessel puncture site bruise'}]",24.0,0.187776,"There were no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol.","[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Balaguer', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'the Early Phase Clinical Unit, PAREXEL International GmbH, Harrow, UK.'}, {'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby-Hamrén', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Astbury', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Seoane', 'Affiliation': 'Biometrics and Information Sciences, Late Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Malice', 'Affiliation': 'Early Biostats and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Alejhandra', 'Initials': 'A', 'LastName': 'Lei', 'Affiliation': 'Patient Safety RIA, Chief Medical Office, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK. ioannis.psallidas@astrazeneca.com.'}]",Respiratory research,['10.1186/s12931-020-01474-1']
2215,32907576,"Navafenterol (AZD8871) in patients with mild asthma: a randomised placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this novel inhaled long-acting dual-pharmacology bronchodilator.","BACKGROUND


Navafenterol (AZD8871) is an inhaled long-acting dual-pharmacology muscarinic antagonist/β 2 -adrenoceptor agonist (MABA) in development for the treatment of obstructive airways diseases. The safety, tolerability, pharmacodynamics, and pharmacokinetics of navafenterol were investigated in patients with mild asthma.
METHODS


This was a randomised, single-blind, placebo-controlled, single-ascending-dose study. Patients were randomly assigned to one of two cohorts which evaluated escalating doses of navafenterol (50-2100 μg) in an alternating manner over three treatment periods. The primary pharmacodynamic endpoint was the change from pre-dose baseline in trough forced expiratory volume in 1 s (FEV 1 ) for each treatment period.
RESULTS


Sixteen patients were randomised; 15 completed treatment. Data from all 16 patients were analysed. The maximum tolerated dose was not identified, and all doses of navafenterol were well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were headache (n = 10, 62.5%) and nasopharyngitis (n = 7, 43.8%). No TEAEs were serious, fatal, or led to discontinuation, and no dose dependency was identified. Navafenterol demonstrated a dose-ordered bronchodilatory response with a rapid onset of action (within 5 min post-dose). Doses ≥200 μg resulted in improvements in trough FEV 1  (mean change from baseline range 0.186-0.463 L) with sustained bronchodilation for 24-36 h. Plasma concentrations increased in a dose-proportional manner, peaking ~ 1 h post-dose, with a derived terminal elimination half-life of 15.96-23.10 h.
CONCLUSIONS


In this study navafenterol was generally well tolerated with a rapid onset of action which was sustained over 36 h.
TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02573155.",2020,"In this study navafenterol was generally well tolerated with a rapid onset of action which was sustained over 36 h.
TRIAL REGISTRATION


ClinicalTrials.gov;","['obstructive airways diseases', 'Sixteen patients were randomised; 15 completed treatment', 'patients with mild asthma']","['2 -adrenoceptor agonist (MABA', 'navafenterol', 'placebo', 'Navafenterol', 'Navafenterol (AZD8871']","['safety, tolerability, pharmacodynamics, and pharmacokinetics of navafenterol', 'headache', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'change from pre-dose baseline in trough forced expiratory volume in 1\u2009s (FEV 1 ', 'trough FEV 1', 'tolerated', 'Plasma concentrations', 'nasopharyngitis']","[{'cui': 'C0600260', 'cui_str': 'Obstructive airways disorder'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",16.0,0.284631,"In this study navafenterol was generally well tolerated with a rapid onset of action which was sustained over 36 h.
TRIAL REGISTRATION


ClinicalTrials.gov;","[{'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, 08020, Barcelona, Spain. lali.jimenez@astrazeneca.com.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Astbury', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Early Phase Clinical Unit, PAREXEL International GmbH, Harrow, UK.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby-Hamrén', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Seoane', 'Affiliation': 'Biometrics and Information Sciences, Late-Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Villarroel', 'Affiliation': 'Late-Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pujol', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Maria Jesus', 'Initials': 'MJ', 'LastName': 'Bermejo', 'Affiliation': 'Patient Safety, Chief Medical Office, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Respiratory research,['10.1186/s12931-020-01470-5']
2216,32909643,Pharmacodynamic analysis of apremilast in Japanese patients with moderate to severe psoriasis: Results from a phase 2b randomized trial.,"We evaluated the pharmacodynamic effects of apremilast in 69 patients who were included in biomarker subanalyses of a phase 2b study that demonstrated the long-term safety and efficacy of apremilast in Japanese adults with moderate to severe psoriasis. The association between cytokine levels and Psoriasis Area and Severity Index (PASI) improvement was evaluated using linear regression and Spearman's rank correlation coefficient analysis. At baseline, median plasma levels of interleukin (IL)-17A, IL-17F and IL-22 were elevated versus reference values for healthy individuals, whereas tumor necrosis factor-α levels were close to normal. With apremilast 30 mg b.i.d., there were significant associations between percentage change in PASI score and percentage change in IL-17A, IL-17F and IL-22 levels at week 16. Findings demonstrate that the efficacy of apremilast in psoriasis is associated with inhibition of key cytokines involved in the pathology of psoriasis.",2020,"At baseline, median plasma levels of interleukin (IL)-17A, IL-17F and IL-22 were elevated versus reference values for healthy individuals, whereas tumor necrosis factor-α levels were close to normal.","['Japanese adults with moderate to severe psoriasis', 'Japanese patients with moderate to severe psoriasis', '69 patients who were included in biomarker subanalyses of a phase 2b study']",[],"['median plasma levels of interleukin (IL)-17A, IL-17F and IL-22', 'pharmacodynamic effects', 'cytokine levels and Psoriasis Area and Severity Index (PASI) improvement', 'tumor necrosis factor-α levels', 'PASI score and percentage change in IL-17A, IL-17F and IL-22 levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",69.0,0.0590281,"At baseline, median plasma levels of interleukin (IL)-17A, IL-17F and IL-22 were elevated versus reference values for healthy individuals, whereas tumor necrosis factor-α levels were close to normal.","[{'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Imafuku', 'Affiliation': 'Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nemoto', 'Affiliation': 'Kojinkai Sapporo Skin Clinic, Sapporo, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Komine', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schafer', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Petric', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Mamitaro', 'Initials': 'M', 'LastName': 'Ohtsuki', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.15596']
2217,32911037,Chronotherapeutic efficacy of suvorexant on sleep quality and metabolic parameters in patients with type 2 diabetes and insomnia.,"AIMS


This study aimed to assess the chronotherapeutic efficacy of suvorexant on subjective sleep parameters and metabolic parameters in patients with type 2 diabetes and insomnia.
METHODS


Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14 ± 2 weeks. The following parameters were assessed before and after the treatment: sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake.
RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p < 0.05), but did not change HbA1c, CGM parameters, or body weight. Correlation analysis revealed that changes in sSE were associated with those in HbA1c and body weight (r = -0.61 and r = -0.66, respectively; both p < 0.05).
CONCLUSIONS


Suvorexant significantly improved sleep quality and obesity-associated parameters in patients with type 2 diabetes in 14 weeks. Improvements in sleep quality were associated with improvements in glycemic control. Sleep disorder treatment using suvorexant may provide metabolic benefits for patients with type 2 diabetes.",2020,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","['patients with type 2 diabetes in 14 weeks', 'Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14±2 weeks', 'patients with type 2 diabetes and insomnia', 'patients with type 2 diabetes']",['suvorexant'],"['sleep quality and obesity-associated parameters', 'glycemic control', 'sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake', 'HbA1c and body weight', 'change HbA1c, CGM parameters, or body weight', 'Chronotherapeutic efficacy', 'sleep quality and metabolic parameters', 'subjective sleep parameters and metabolic parameters', 'sleep quality', 'sSE, abdominal circumference, and sucrose intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0556137', 'cui_str': 'Sucrose intake'}]",13.0,0.026373,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","[{'ForeName': 'Fukumi', 'Initials': 'F', 'LastName': 'Yoshikawa', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Fumika', 'Initials': 'F', 'LastName': 'Shigiyama', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyagi', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Uchino', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kumashiro', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan. Electronic address: naoki.kumashiro@med.toho-u.ac.jp.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108412']
2218,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND


Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD


This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS


Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2  = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS


The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
2219,32911138,"Short-term oral corticosteroids for initial treatment of moderate-to-severe persistent asthma: A double-blind, randomized, placebo-controlled trial.","BACKGROUND AND PURPOSE


The purpose of this study was to investigate that on the basis of ICS-LABA treatment, whether or not adding on short course of oral corticosteroid could increase the rate of asthma control.
METHODOLOGY


This was a double blind, randomized controlled study. Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic. All patients included in the study received ICS-LABA as initial treatment. Two weeks oral corticosteroid or placebo were added on at the beginning of treatment. All the subjects were followed-up by daily measurement of PEF and asthma diary for 12 week and spirometry at 4 weeks and 12 weeks.
RESULTS


13 cases were randomized to Corticosteroid group (M/F: 9/4, age: 45.0 ± 5.0 yrs), 11 to Placebo group (M/F: 4/7, age: 35.7 ± 9.6yrs). After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05). However, there were no significant difference between two groups in the improvement of ACT、ACQ、AQLQ、FEV1、FEV1% (all P > 0.05). After 4 weeks of treatment, total control was achieved in 3 (30.8%) in corticosteroid group and 2 (18.2%) in placebo group; Partial control was achieved in 7 (61.5%)in corticosteroid group and in 7 (63.6%) in placebo group. There was no significant difference in control rates between two groups (X 2  = 0.919, P = 0.632). Similar findings were observed after 12 weeks of treatment.
CONCLUSION


In maintenance treatment naïve moderate to severe persistent asthma, ICS-LABA therapy was adequate initial treatment for achieving asthma control in majority of the patients. Add on short course of oral corticosteroid provided no significant clinical benefit.",2020,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","['moderate-to-severe persistent asthma', '13 cases', 'Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic']","['Short-term oral corticosteroids', 'corticosteroid or placebo', 'placebo', 'ICS-LABA', 'Corticosteroid', 'Placebo']","['total control', 'control rates', 'rate of asthma control']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",13.0,0.251154,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","[{'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dongming', 'Initials': 'D', 'LastName': 'Hua', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Guangzhou Overseas Chinese Hospital, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China. Electronic address: chenrc@vip.163.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106126']
2220,32911210,Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach.,"BACKGROUND


The purpose of this study is to evaluate the effectiveness of the Mindfulness-based Stress Reduction program applied to a sample of Turkish nursing students.
METHOD


The study was designed as a randomized controlled trial. Program sessions of 90-95 minutes were given twice a week for 12 weeks. The data were collected using the Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale.
RESULTS


A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions. On the Mindfulness Scale, a statistically significant difference was found between the mean pre-test and post-test scores obtained by the experiment and control groups.
CONCLUSION


The results derived from this study suggest that the mindfulness-based stress reduction program is effective in reducing the stress experienced by students during nursing education, increasing their mindfulness, strengthening their coping mechanisms for stress, increasing their use of self-confident and optimistic approaches, and decreasing their use of the helpless approach.",2020,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"['Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students', 'Turkish nursing students']","['mindfulness-based stress reduction program', 'Mindfulness-based Stress Reduction program']","['Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale', 'Nursing Education Stress Scale']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",95.0,0.0107001,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yıldırım Şişman', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: nuriyeyildirim@duzce.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: ayselkaraca@duzce.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cangür', 'Affiliation': 'DuzceUniversity, Faculty of Medicine, Department of Biostatistics and Medical Informatics, Duzce, Turkey. Electronic address: sengulcangur@duzce.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102880']
2221,32917300,Fit to Study: Reflections on designing and implementing a large-scale randomized controlled trial in secondary schools.,"BACKGROUND


The randomised controlled trial (RCT) design is increasingly common among studies seeking good-quality evidence to advance educational neuroscience, but conducting RCTs in schools is challenging. Fit to Study, one of six such trials funded by the Education Endowment Foundation and Wellcome Trust, tested an intervention to increase vigorous physical activity during PE lessons on maths attainment among pupils aged 12-13. This review of designing and conducting an RCT in 104 schools is intended as a resource on which researchers might draw for future studies.
METHOD


We consider intervention design and delivery; recruitment, retention, trial management, data collection and analysis including ethical considerations and working with evaluators.
RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
CONCLUSION


Simple interventions, with few outcome measures and minimal missing data, are preferable to more complex designs.",2020,"RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
","['pupils aged 12-13', '104 schools']",[],[],"[{'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],[],,0.112651,"RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wheatley', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU. Electronic address: catherine.wheatley@ndcn.ox.ac.uk.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Beale', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wassenaar', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Oxford Uehiro Centre for Practical Ethics, Wellcome Centre for Ethics and Humanities, University of Oxford, 6-17 St Ebbes St, Oxford OX1 1PT.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Eldridge', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Johansen-Berg', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU.'}]",Trends in neuroscience and education,['10.1016/j.tine.2020.100134']
2222,32917317,"Effect of porcine placental extract on menopausal symptoms in postmenopausal women: A prospective, randomized, double-blind, placebo-controlled trial.","OBJECTIVES


To determine the effect of oral administration of porcine placental extract (PPE) on the menopausal symptoms of Korean women.
MATERIALS AND METHODS


This study was a multicenter, randomized double-blind placebo-controlled trial. A hundred menopausal Korean women were randomly allocated either to the PPE 400 mg per day or the control group during 12 weeks of the study period. Menopausal symptoms were evaluated using the Kupperman Index (KMI).
RESULTS


The KMI decreased after 12 weeks in both groups; however, the difference in the changes was not statistically significant. Among overweight or obese women whose body mass index (BMI) was 23 kg/m 2  or higher, the KMI decreased more significantly in the PPE group than placebo group after 12 weeks (-18.52 ± 9.09 vs -11.40 ± 10.68, P < 0.05). Among 49 early menopausal women whose duration of menopause was less than 3 years, the KMI decreased more significantly in the PPE group after 12 weeks (-17.29 ± 9.07 vs -11.29 ± 10.68, P < 0.05). The baseline estradiol level was not statistically different between the two groups before trial, but the estradiol level of the PPE group was significantly increased at 12 weeks (11.13 ± 35.13 pg/m, P < 0.05).
CONCLUSIONS


Oral administration of 400 mg PPE per day decreases menopausal symptoms in women with BMI 23 kg/m 2  or higher or in early menopausal women. PPE may be considered as a short-term complementary treatment to reduce menopausal symptoms, especially in overweight or early menopausal women.",2020,"The baseline estradiol level was not statistically different between the two groups before trial, but the estradiol level of the PPE group was significantly increased at 12 weeks (11.13 ± 35.13 pg/m, P ","['overweight or early menopausal women', 'A hundred menopausal Korean women', 'postmenopausal women', 'women with BMI 23\xa0kg/m 2  or higher or in early menopausal women', 'Korean women', '49 early menopausal women']","['porcine placental extract (PPE', 'placebo', 'PPE', 'porcine placental extract']","['body mass index (BMI', 'menopausal symptoms', 'baseline estradiol level', 'Menopausal symptoms', 'Kupperman Index (KMI', 'estradiol level', 'duration of menopause', 'KMI']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]",,0.493711,"The baseline estradiol level was not statistically different between the two groups before trial, but the estradiol level of the PPE group was significantly increased at 12 weeks (11.13 ± 35.13 pg/m, P ","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Konkuk University Hospital, Konkuk University School of Medicine, Seoul, Republic of Korea. Electronic address: jylee@kuh.ac.kr.'}, {'ForeName': 'Chulmin', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, CHA University Ilsan Medical Center, Goyang, Republic of Korea. Electronic address: morula3@gmail.com.'}, {'ForeName': 'Sang-Hee', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University School of Medicine, Seoul, Republic of Korea. Electronic address: psimy81@gmail.com.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Healthcare Review and Assessment Committee, Health Insurance Review and Assessment Service, Seoul, Republic of Korea. Electronic address: hoonchoi54@gmail.com.'}]",Taiwanese journal of obstetrics & gynecology,['10.1016/j.tjog.2020.07.009']
2223,32917318,Effectiveness and safety of atosiban versus conventional treatment in the management of preterm labor.,"OBJECTIVE


To compare the efficacy of atosiban with conventional treatment of the threatened preterm labor.
MATERIALS AND METHODS


All the data of pregnant women with threatened preterm labor from January 1 to December 31, 2017, who received atosiban were collected. Pregnant women with conventional treatment (including β-agonists, indomethacin, magnesium sulphate and calcium channel blockers, alone or in combination) were used as control.
RESULTS


The proportion of women not requiring an alternative tocolytic treatment within 48 h and remaining undelivered was significantly higher in atosiban treatment group (89.3%; n = 25/28) compared with conventional treatment (24.2%; n = 8/33) (P < 0.0001). For therapy efficacy, there was also no significant difference between atosiban groups and conventional treatment groups in the low gestational ages. However, for the high gestational ages, atosiban treatment group showed higher efficacy (84%; n = 21/25 vs. 37.5%; n = 3/8) (P < 0.05). Moreover, a significantly higher proportion of women in the atosiban treated group (89.3%; n = 25/28) was observed compared with the conventional treatment groups (51.5%; n = 17/33) who did not receive an alternative tocolytic within 48 h (P < 0.01). Maternal and fetal safety was significantly superior with atosiban treatment.
CONCLUSIONS


Our results support that atosiban would represent an advance over current tocolytic therapy especially for the high gestational ages.",2020,The proportion of women not requiring an alternative tocolytic treatment within 48 h and remaining undelivered was significantly higher in atosiban treatment group (89.3%; n = 25/28) compared with conventional treatment (24.2%; n = 8/33),"['pregnant women with threatened preterm labor from January 1 to December 31, 2017, who received atosiban were collected', 'Pregnant women with conventional treatment (including β-agonists', 'preterm labor', 'within 48']","['indomethacin, magnesium sulphate and calcium channel blockers, alone or in combination', 'alternative tocolytic', 'atosiban versus conventional treatment']","['efficacy', 'Maternal and fetal safety', 'proportion of women not requiring an alternative tocolytic treatment']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0040349', 'cui_str': 'Tocolytic agent'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}]",,0.0324973,The proportion of women not requiring an alternative tocolytic treatment within 48 h and remaining undelivered was significantly higher in atosiban treatment group (89.3%; n = 25/28) compared with conventional treatment (24.2%; n = 8/33),"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Joint Surgery, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Clinic for Gynecology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China.'}, {'ForeName': 'Yuanfang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China. Electronic address: zhuyuanfang111@163.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China. Electronic address: guofang2200@163.com.'}]",Taiwanese journal of obstetrics & gynecology,['10.1016/j.tjog.2020.07.010']
2224,32917359,"Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium) versus nebulized short-acting dual bronchodilator (salbutamol/ipratropium) in chronic obstructive pulmonary disease: A double-blind, randomized, placebo-controlled trial.","INTRODUCTION


Most guidelines recommend long-acting bronchodilators over short-acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD). The available evidence for the guidelines was based on dry powder or pressurized metered dose inhalers, but not nebulizations. Nevertheless, there is considerable, poorly evidenced based, use of short acting nebulized bronchodilators.
METHODS


This was an investigator initiated, randomized, active controlled, cross-over, double-blind and double-dummy single centre study in patients with stable COPD. The active comparators were indacaterol/glycopyrronium 110/50 μg as Ultibro® via Breezhaler® (IND/GLY) and salbutamol/ipratropium 2,5/0,5 mg via air driven nebulization (SAL/IPR), both given as a single dose on separate days. The primary end point was the area under the FEV 1  curve from baseline till 6 h. Secondary end points included change in Borg dyspnoea score, adverse events and change in hyperinflation measured by the inspiratory capacity.
RESULTS


A total of 33 COPD patients completed the trial and were evaluable, most of them were ex-smokers. The difference between the tested regimens for the primary endpoint, FEV 1  AUC 0-6 h, 2965 ± 1544 mL (mean ± SD) for IND/GLY versus 3513 ± 1762 mL for SAL/IPR, was not significant (P = 0.08). The peak in FEV1 was higher and was reached faster with SAL/IPR compared to IND/GLY. No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
CONCLUSION


Among patients with stable COPD, dry powder long-acting single inhalation of a LABA and a LAMA (IND/GLY) was not superior compared to nebulized short-acting salbutamol plus ipratropium (SAL/IPR) in its bronchodilating effects over 6 h.The effects of the nebulization kicked in faster and peaked higher. The observed differences may be caused by the difference in dosing between the two regimens. The improvement in Borg dyspnoea score did not favour the nebulization. Long-term outcomes were not assessed in this study.",2020,"No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
","['chronic obstructive pulmonary disease', '33 COPD patients', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with stable COPD']","['IND', 'Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium', 'salbutamol plus ipratropium (SAL/IPR', 'indacaterol/glycopyrronium 110/50\xa0μg as Ultibro® via Breezhaler® (IND/GLY) and salbutamol/ipratropium 2,5/0,5\xa0mg via air driven nebulization (SAL/IPR', 'placebo', 'nebulized short-acting dual bronchodilator (salbutamol/ipratropium']","['area under the FEV 1  curve', 'Borg score, or adverse events', 'peak in FEV1', 'Borg dyspnoea score', 'change in Borg dyspnoea score, adverse events and change in hyperinflation measured by the inspiratory capacity', 'FEV 1  AUC 0-6\xa0h, 2965\xa0±']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0578554', 'cui_str': 'Inhaled bronchodilator therapy'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",33.0,0.528759,"No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
","[{'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Medical Centre Leeuwarden, Department of Respiratory Medicine, Leeuwarden, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands. Electronic address: wouter.van.geffen@znb.nl.'}, {'ForeName': 'Orestes A', 'Initials': 'OA', 'LastName': 'Carpaij', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Lotte F', 'Initials': 'LF', 'LastName': 'Westbroek', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Seigers', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Niemeijer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Vonk', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106064']
2225,32907638,Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The main aim of the study is to evaluate the efficacy of a single dose of sarilumab, in subcutaneous administration, in hospitalised patients with moderate to early severe COVID-19 infection compared to the current standard of care, to prevent progression to systemic hyperinflammatory status. Our hypothesis is that use of subcutaneous sarilumab in early stages (window of opportunity) of COVID-19 moderate-severe pneumonia can prevent higher oxygenation requirements through non-invasive and invasive mechanical ventilation and decrease in-hospital stays, as well as death rate. The secondary objectives of the study are to evaluate the safety of sarilumab through hospitalisation and up to day 14 after discharge, compared to the control arm as assessed by incidence of serious and non serious adverse events (SAEs). In addition, as an exploratory objective, to compare the baseline clinical and biological parameters, including serum IL-6 levels, of the intervention population against controls of the same pandemic outbreak (using a propensity score) to search for markers that identify the best candidates for the treatment with subcutaneous IL-6R inhibitors and to attempt an approximation in the temporal frame of the ""window of opportunity"" TRIAL DESIGN: SARCOVID is an investigator-initiated single center randomised proof of concept study.
PARTICIPANTS


Patients treated at the Hospital Universitario La Princesa, Madrid, Spain requiring hospitalisation will be consecutively recruited, meeting all inclusion criteria and none of the exclusion criteria Inclusion criteria a. Age >18, <80 years old b. COVID-19 infection documented by a positive RT-PCR test or, in absence of a RT-PCR positive test, case definition of COVID 19 infection/pneumonia as per local protocol and the presence of a positive serologic test (IgM/IgA by ELISA) c. Documented interstitial pneumonia requiring admission and at least two of the following parameters: 1) Fever ≥ 37.8°C (tympanic) 2) IL-6 in serum ≥ 25 pg/mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg/dL 3) Lymphocytes <600 cells/mm 3  4) Ferritin> 300 μg/L that doubles in 24 hours 5) Ferritin> 600 μg/L in the first determination and LDH> 250 U/L 6) D-dimer (> 1 mg/L) d. Informed verbal consent or requested under urgent conditions, documented in the electronic medical record. Exclusion criteria a. Patients who require mechanical ventilation at the time of inclusion. b. AST / ALT values > 5 folds the ULN. c. Absolute neutrophil count below 500 cells/mm 3  d. Absolute platelet count below 50,000 cells/mm 3  e. Documented sepsis or high suspicion of superimposed infection by pathogens other than COVID-19. f. Presence of comorbidities that can likely lead to an unfavourable result according to clinical judgment. g. Complicated diverticulitis or intestinal perforation. h. Current skin infection (eg, uncontrolled dermopiodermitis). i. Immunosuppressive anti-rejection therapy. j. Pregnancy or lactation. k. Previous treatment with tocilizumab or sarilumab. l. Patients participating in another clinical trial for SARS-CoV-2 infection. m. Patients with known hypersensitivity or contraindication to sarilumab or excipients.
INTERVENTION AND COMPARATOR


The intervention group, sarilumab plus standard of care, will receive 400 mg single dose treatment with Sarilumab (Kevzara), 2 subcutaneous injections 200mg each in a pre-filled syringe. Treatment with drugs or procedures in routine clinical practice that the clinician responsible for the patient deems necessary is allowed. The control group will receive drugs or procedures in routine clinical practice according to the best standard of care as per local protocol.
MAIN OUTCOMES


Primary Outcome Measures 1. Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7) 1. Death; 2. Hospitalised, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalised, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalised, requiring supplemental oxygen; 5. Hospitalised, not requiring supplemental oxygen - but in need of ongoing medical care (COVID-19 related or otherwise) 6. Hospitalised, not requiring supplemental oxygen - no longer requires ongoing medical care (independent) 7. Not hospitalised 2. Duration of hospitalisation: Days from the date of enrolment to the date of discharge 3. Number of deaths at the end of study RANDOMISATION: Randomisation to treatment arms sarilumab plus standard of care or standard of care in a 2:1 ratio will be performed by the Clinical Research and Clinical Trials Unit (CRCTU) at the Hospital using a table of random numbers, an internet-based randomisation tool. After checking that all inclusion criteria are met and none of the exclusion criteria, CRCTU will communicate the recruiting investigator the assigned treatment.
BLINDING (MASKING)


This study is unblinded.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


30 patients treated by COVID-19 infection who require hospitalisation: 20 will receive sarilumab plus Standard of Care and 10 will receive Standard of Care.
TRIAL STATUS


The Protocol version number is 2, as of 6 th  April 2020, with amendment 1, as of 7 th  May 2020. The recruitment is ongoing. Recruitment started on April 13 th  2020 and is anticipated to be completed by November 2020.
TRIAL REGISTRATION


This trial was first registered in the European Union Clinical Trials Register on 4 April 2020, EudraCT Number 2020-001634-36 . Then, posted on ClinicalTrials.gov on 22 April 2020, Identifier: NCT04357808 .
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the International Council Harmonization guidelines: https://www.ich.org/page/efficacy-guidelines .",2020,Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7) 1.,"['30 patients treated by COVID-19 infection who require hospitalisation: 20 will receive', 'm. Patients with known hypersensitivity or contraindication to sarilumab or excipients', 'l. Patients participating in another clinical trial for SARS-CoV-2 infection', 'Exclusion criteria a. Patients who require mechanical ventilation at the time of inclusion', 'European Union Clinical Trials Register on 4 April 2020, EudraCT Number 2020-001634-36 ', 'Patients treated at the Hospital Universitario La Princesa, Madrid, Spain requiring hospitalisation will be consecutively recruited, meeting all inclusion criteria and none of the exclusion criteria Inclusion criteria a. Age >18, <80 years old b. COVID-19 infection documented by a positive RT-PCR test or, in absence of a RT-PCR positive test, case definition of COVID 19 infection/pneumonia as per local protocol and the presence of a positive serologic test (IgM/IgA by ELISA', 'hospitalised patients with moderate-severe COVID-19 infection', 'hospitalised patients with moderate to early severe COVID-19 infection']","['prednisone', 'tocilizumab or sarilumab', 'sarilumab plus standard of care, will receive 400 mg single dose treatment with Sarilumab (Kevzara), 2 subcutaneous injections 200mg each in a pre-filled syringe', 'sarilumab', 'sarilumab plus Standard of Care and 10 will receive Standard of Care', 'IL-6', 'sarilumab plus standard of care or standard of care', 'LDH', 'invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO', 'subcutaneous IL-6R inhibitors', 'Immunosuppressive anti-rejection therapy', 'Subcutaneous Sarilumab']","['Number of deaths', 'serum IL-6 levels', 'hospital stays', 'Duration of hospitalisation', 'incidence of serious and non serious adverse events (SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0015237', 'cui_str': 'Pharmaceutical excipient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.221557,Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7) 1.,"[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Garcia-Vicuña', 'Affiliation': 'Rheumatology Department, Hospital Universitario de la Princesa, Madrid, Spain. mariadelrosario.garcia@salud.madrid.org.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Abad-Santos', 'Affiliation': 'Faculty of Medicine, Universidad Autónoma de Madrid (UAM), Madrid, Spain.'}, {'ForeName': 'Isidoro', 'Initials': 'I', 'LastName': 'González-Alvaro', 'Affiliation': 'Rheumatology Department, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramos-Lima', 'Affiliation': 'Medical Affairs Department, Immunology Area, Sanofi Spain, Madrid, Spain.'}, {'ForeName': 'Jesús Sanz', 'Initials': 'JS', 'LastName': 'Sanz', 'Affiliation': 'Instituto de Investigación Sanitaria La Princesa (IIS-IP), Madrid, Spain.'}]",Trials,['10.1186/s13063-020-04588-5']
2226,32908702,"Corrigendum to ""Effects of Number of Repetitions and Number of Hours of Shaping Practice during Constraint-Induced Movement Therapy: A Randomized Controlled Trial"".",[This corrects the article DOI: 10.1155/2018/5496408.].,2020,[This corrects the article DOI: 10.1155/2018/5496408.].,[],['Number of Repetitions and Number of Hours of Shaping Practice during Constraint-Induced Movement Therapy'],[],[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}]",[],,0.0977632,[This corrects the article DOI: 10.1155/2018/5496408.].,"[{'ForeName': 'Auwal', 'Initials': 'A', 'LastName': 'Abdullahi', 'Affiliation': 'Department of Physiotherapy, Bayero University Kano, Kano, Kano State, Nigeria.'}]",Neurology research international,['10.1155/2020/1256231']
2227,32909336,Mechanism and prevention of facial pressure injuries: A novel emergent strategy supported by a multicenter controlled study in frontline healthcare professionals fighting COVID-19.,"Numerous healthcare professionals fighting COVID-19 worldwide are suffering from the protective respirators related facial pressure injuries. This study explored the mechanism and prevention of such injuries and devised a novel emergent strategy, which was supported by a multicenter self-controlled study in 1161 frontline healthcare professionals. In this study, according to the anatomy of the face and the characteristics of facial pressure injuries, a respirator liner was designed using a polyurethane foam to redistribute the pressure across the face. A preclinical crossover trial was performed on eight participants to evaluate its efficacy. The strategy was then widely applied among 11  100 healthcare workers in seven frontline hospitals, and 1161 of them were sampled for a questionnaire investigation. The preclinical crossover trial showed that the novel strategy was very effective in preventing facial pressure injuries. The questionnaire investigation showed that pain score, wearing disturbance, and the incidence of pressure injury in the healthcare professionals were significantly correlated with wearing time (all ρ = 0.986). The new strategy significantly reduced the incidence of pressure injury from 84.7% to 11.1%, pain score IQR from 5 (2) to 1 (2), and wearing disturbance rate from 91.6% to 6.3%, and the results analyzed according to individual hospitals or different wearing time showed similar trends (all P < .0005). The protective respirators related facial pressure injuries can be effectively mitigated with this emergent strategy, which has also been applied in some European hospitals and can be popularized to help more healthcare professionals who are combating COVID-19 on the frontlines.",2020,"The new strategy significantly reduced the incidence of pressure injury from 84.7% to 11.1%, pain score IQR from 5 (2) to 1 (2), and wearing disturbance rate from 91.6% to 6.3%, and the results analyzed according to individual hospitals or different wearing time showed similar trends (all P < 0.0005).","['11 100 healthcare workers in seven frontline hospitals, and 1161 of them were sampled for a questionnaire investigation', 'facial pressure injuries', '1161 frontline healthcare professionals']",[],"['wearing disturbance rate', 'incidence of pressure injury', 'facial pressure injuries', 'pain score IQR', 'pain score, wearing disturbance, and the incidence of pressure injury']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",8.0,0.027149,"The new strategy significantly reduced the incidence of pressure injury from 84.7% to 11.1%, pain score IQR from 5 (2) to 1 (2), and wearing disturbance rate from 91.6% to 6.3%, and the results analyzed according to individual hospitals or different wearing time showed similar trends (all P < 0.0005).","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xinzhu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yuezeng', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': ""Chuan'an"", 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital, Beijing, China.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12862']
2228,32910476,Higher serum PD-L1 level predicts increased overall survival with lapatinib versus trastuzumab in the CCTG MA.31 phase 3 trial.,"BACKGROUND


The purpose of this retrospective biomarker study of the Canadian Cancer Trials Group (CCTG) MA.31 randomized phase 3 trial (lapatinib vs trastuzumab) of HER2-positive metastatic breast cancer (MBC) was to evaluate the prognostic and predictive biomarker utility of pretreatment serum programmed death ligand 1 (PD-L1) levels.
METHODS


CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm). The Ella immunoassay platform (ProteinSimple, San Jose, California) was used to quantitate serum PD-L1 levels. Stepwise forward Cox multivariable analyses were performed for progression-free survival and overall survival (OS).
RESULTS


In the whole trial population, continuous pretreatment serum PD-L1 levels were not associated with OS. However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37). In the whole trial, in a multivariable analysis for OS, serum PD-L1 (median cut point) remained a significant independent covariate (HR, 2.38; P = .001). There was a significant interaction between treatment arm and continuous serum PD-L1 (bootstrap method; P = .0025): at or above 214.2 pg/mL (the 89th percentile), serum PD-L1 was associated with significantly shorter OS with trastuzumab treatment versus lapatinib treatment.
CONCLUSIONS


In the CCTG MA.31 trial, serum PD-L1 was a significant predictive factor: a higher pretreatment serum PD-L1 level was associated with shorter OS with trastuzumab treatment but with longer OS with lapatinib treatment. Immune evasion may decrease the effectiveness of trastuzumab therapy. Further evaluation of elevated serum PD-L1 in advanced breast cancer is warranted to identify patients with HER2-positive MBC who may benefit from novel immune-targeted therapies in addition to trastuzumab.",2020,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","['CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm', 'HER2-positive metastatic breast cancer (MBC', 'patients with HER2-positive MBC']","['lapatinib versus trastuzumab', 'lapatinib vs trastuzumab']","['serum PD-L1', 'progression-free survival and overall survival (OS', 'serum PD-L1 levels', 'serum PD-L1 level', 'overall survival']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",652.0,0.0795987,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","[{'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Moku', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Suhail M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Leitzel', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Virk', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Nomikos', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Aparicio', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Drabick', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Cream', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'E Scott', 'Initials': 'ES', 'LastName': 'Halstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Umstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Mckeone', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Hyma', 'Initials': 'H', 'LastName': 'Polimera', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Maddukuri', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Aamnah', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Nagabhairu', 'Affiliation': 'Pinnacle Health, Harrisburg, Pennsylvania.'}, {'ForeName': 'Joyson', 'Initials': 'J', 'LastName': 'Poulose', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pancholy', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'ProteinSimple, San Jose, California.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Lipton', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}]",Cancer,['10.1002/cncr.33149']
2229,32911350,Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.,"INTRODUCTION


PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
METHODS


This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).
RESULTS


Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ 2 [1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ 2 [1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ 2 [1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ 2 [1] = 4.43, p = 0.04).
CONCLUSIONS


Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.",2020,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.",['smokers with HIV'],"['varenicline and placebo', 'varenicline', 'varenicline vs. placebo', 'varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation', 'placebo']","['nicotine metabolism rate', 'varenicline quit rate', 'quit rate for varenicline', 'quit rate', 'Medication adherence and rate of nicotine metabolism', 'faster nicotine metabolism']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",179.0,0.482863,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.","[{'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine/Division of Pulmonary, Allergy, & Critical Care, University of Pennsylvania, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Pennsylvania, United States; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, United States. Electronic address: schnoll@pennmedicine.upenn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106638']
2230,32905725,Methadone and a Clinical Pathway in Adolescent Idiopathic Scoliosis Surgery: A Historically Controlled Study.,"STUDY DESIGN


Historically controlled clinical trial.
OBJECTIVES


Patients presenting for correction of adolescent idiopathic scoliosis (AIS) by posterior spinal fusion may benefit from structured clinical pathways. We studied the effects of implementing a published clinical pathway for the perioperative care of patients with AIS that required intraoperative use of methadone at our institution.
METHODS


We performed a historically controlled clinical trial of patients undergoing posterior spinal fusion for AIS by comparing a retrospectively collected control group of 25 patients with a prospective experimental group of 14 patients receiving methadone, gabapentin, propofol, and remifentanil as part of a new clinical pathway.
RESULTS


Use of the pathway decreased average pain scores evaluated by the Numeric Rating Scale in the 24 hours following surgery (4.8 [4-6] to 3.4 [2-4],  P  = .03 [-2.6 to -0.2;  t  = -2.3]) and postoperative opioid consumption by 76% (41 [29-51] mg to 10 [4-17] mg,  P  < .001 [-45 to -15; Welch's  t  = 4.9]) during the same period. Improved analgesia and reduced reliance on opioids facilitated other postoperative elements of the clinical pathway and shortened the average hospital length of stay by 1 day (4 [3-6] days to 3 [3-5] days,  P  = .001 [-2 to -1;  U  = 67,  Z  = -3.3]).
CONCLUSIONS


Multimodal analgesia and a clinical pathway add value in the perioperative care of patients undergoing posterior spinal fusion for AIS by improving analgesia and shortening hospitalization. The prospective arm of the trial was registered at clinicaltrials.gov under NCT02481570.",2020,"Improved analgesia and reduced reliance on opioids facilitated other postoperative elements of the clinical pathway and shortened the average hospital length of stay by 1 day (4 [3-6] days to 3 [3-5] days,  P  = .001","['Patients presenting for correction of adolescent idiopathic scoliosis (AIS', 'patients with AIS that required intraoperative use of methadone at our institution', 'as part of a new clinical pathway', 'patients undergoing posterior spinal fusion for AIS by comparing a retrospectively collected control group of 25 patients with a prospective experimental group of 14 patients receiving', 'patients undergoing posterior spinal fusion for AIS by improving analgesia and shortening hospitalization', 'Adolescent Idiopathic Scoliosis Surgery']","['methadone, gabapentin, propofol, and remifentanil', 'Methadone']","['average pain scores', 'average hospital length of stay', 'Numeric Rating Scale', 'postoperative opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",25.0,0.0384119,"Improved analgesia and reduced reliance on opioids facilitated other postoperative elements of the clinical pathway and shortened the average hospital length of stay by 1 day (4 [3-6] days to 3 [3-5] days,  P  = .001","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Tams', 'Affiliation': '7060University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'F Cole', 'Initials': 'FC', 'LastName': 'Dooley', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Taranjit S', 'Initials': 'TS', 'LastName': 'Sangari', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Sandra N', 'Initials': 'SN', 'LastName': 'Gonzalez-Rodriguez', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Stoker', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Koenig', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Wishin', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Molinari', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Laurel C', 'Initials': 'LC', 'LastName': 'Blakemore', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Christoph N', 'Initials': 'CN', 'LastName': 'Seubert', 'Affiliation': '7060University of Utah Hospital, Salt Lake City, UT, USA.'}]",Global spine journal,['10.1177/2192568219878135']
2231,32905889,Role of inhaled corticosteroids in reducing exacerbations in bronchiectasis patients with blood eosinophilia pooled post-hoc analysis of 2 randomized clinical trials.,,2020,,['bronchiectasis patients with blood eosinophilia'],['inhaled corticosteroids'],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.174446,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. Electronic address: lsaderi@uniss.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Respiratory medicine,['10.1016/j.rmed.2020.106127']
2232,32905893,12-months follow-up of pulmonary tele-rehabilitation versus standard pulmonary rehabilitation: A multicentre randomised clinical trial in patients with severe COPD.,"Between March 2016 and October 2017, we randomised 134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group). We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme. The current study presents results from the 12-month follow-up with assessment of the 6MWD and analyses of hospitalisation and mortality. There were no significant differences between or within the groups in the 6MWD one year after completion of the programme.",2020,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"['134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient', 'patients with severe COPD']","['pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group', 'pulmonary tele-rehabilitation versus standard pulmonary rehabilitation']",['minutes walking distance (6MWD'],"[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",134.0,0.0811644,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark; Institute for Clinical Medicine, University of Copenhagen, Denmark. Electronic address: Nina.Skavlan.Godtfredsen@regionh.dk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'The Research Unit for General Practice, Department of Public Health, University of Copenhagen, And Innovation and Research Centre for Multimorbidity and Chronic Conditions, Region Zealand, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical & Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Department of Respiratory Medicine, Gentofte and Herlev University Hospital, Gentofte, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle Frost', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106129']
2233,32905977,A preliminary study on the application of DTI in the treatment of brain tumors in motor function areas with gamma knife.,"OBJECTIVES


The treatment safety and efficiency as well as the life quality of patients are still main concerns in gamma knife radiosurgery. In this study, the feasibility of applying diffusion tensor imaging (DTI) in gamma knife radiosurgery for the treatment of brain tumor in motor function areas was investigated, which aims to provide protection on the pyramidal tract and preserve the motor function in patients.
PATIENTS AND METHODS


Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group. The tumor control rate was assessed at 3 months after surgery. The muscle strength of affected limb, KPS scores, ZEW scores and complications were evaluated at 3 and 6 months after gamma knife radiosurgery.
RESULTS


Our results indicated that the tumor control rate, complication rate, the muscle strength of affected limb and KPS scores were not significantly different between the two groups at 3 months after surgery. At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group. Furthermore, the stability of muscle strength in patients with limb dysfunction was significantly improved in DTI group (86.4 % vs 50 %, P = 0.028).
CONCLUSION


In summary, the application of DTI in gamma knife radiosurgery for the treatment of brain tumors in motor function areas can precisely define the tumor edge from pyramidal tract, which will support on designing individual treatment plan, reducing the incidence of complications, and improving long-term life quality in patients.",2020,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","['Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group', 'patients', 'brain tumors in motor function areas with gamma knife']","['DTI', 'diffusion tensor imaging (DTI', 'gamma knife radiosurgery']","['tumor control rate', 'ZEW scores', 'limb dysfunction', 'tumor control rate, complication rate, the muscle strength of affected limb and KPS scores', 'complication rate', 'KPS scores', 'muscle strength of affected limb, KPS scores, ZEW scores and complications', 'stability of muscle strength']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",74.0,0.018093,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","[{'ForeName': 'Yadi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China. Electronic address: hongweiwangimmu@yahoo.com.'}, {'ForeName': 'Zhanbiao', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Magnetic Resonance Imaging, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nuclear Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Guorong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106169']
2234,32906135,Tubular Biomarkers and Chronic Kidney Disease Progression in SPRINT Participants.,"BACKGROUND


Kidney tubular atrophy on biopsy is a strong predictor of chronic kidney disease (CKD) progression, but tubular health is poorly quantified by traditional measures including estimated glomerular filtration rate (eGFR) and albuminuria. We hypothesized that urinary biomarkers of impaired tubule function would be associated with faster eGFR declines in persons with CKD.
METHODS


We measured baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m) among 2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2. We used linear mixed models to evaluate biomarker associations with annualized relative change in eGFR, stratified by randomization arm.
RESULTS


At baseline, the mean age was 73 ± 9 years and eGFR was 46 ± 11 mL/min/1.73 m2. In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10 [95% CI: -0.18, -0.02]) in multivariable-adjusted models including baseline eGFR and albuminuria. Associations were weaker and did not reach statistical significance in the intensive blood pressure treatment arm for either uromodulin (0.11 [-0.13, 0.35], p value for interaction by treatment arm = 0.045) or β2m (-0.01 [-0.08, 0.08], p value for interaction = 0.001). Urinary α1m was not independently associated with eGFR decline in the standard (0.01 [-0.22, 0.23]) or intensive (0.03 [-0.20, 0.25]) arm.
CONCLUSIONS


Among trial participants with hypertension and CKD, baseline measures of tubular function were associated with subsequent declines in kidney function, although these associations were diminished by intensive blood pressure control.",2020,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","['2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2', 'persons with CKD', 'SPRINT Participants']",[],"['baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m', 'Tubular Biomarkers and Chronic Kidney Disease Progression', 'annual eGFR decline', 'eGFR decline', 'intensive blood pressure control', 'kidney function', 'Urinary α1m', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",2428.0,0.0823971,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","[{'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA, vasantha.jotwani@ucsf.edu.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Department of Medicine, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension Research Institute, Carollton, Texas, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Segal', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000509978']
2235,32912199,The effect on work presenteeism of job retention vocational rehabilitation compared to a written self-help work advice pack for employed people with inflammatory arthritis: protocol for a multi-centre randomised controlled trial (the WORKWELL trial).,"BACKGROUND


Work problems are common in people with inflammatory arthritis. Up to 50% stop work within 10 years due to their condition and up to 67% report presenteeism (i.e. reduced work productivity), even amongst those with low disease activity. Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations. This aims to create a better match between the person's abilities and their job demands. The objectives of the Workwell trial are to test the overall effectiveness and cost-effectiveness of JRVR (WORKWELL) provided by additionally trained National Health Service (NHS) occupational therapists compared to a control group who receive self-help information both in addition to usual care.
METHODS


Based on the learning from a feasibility trial (the WORK-IA trial: ISRCTN76777720 ), the WORKWELL trial is a multi-centre, pragmatic, individually-randomised parallel group superiority trial, including economic evaluation, contextual factors analysis and process evaluation. Two hundred forty employed adults with rheumatoid arthritis, undifferentiated inflammatory arthritis or psoriatic arthritis (in secondary care), aged 18 years or older with work instability will be randomised to one of two groups: a self-help written work advice pack plus usual care (control intervention); or WORKWELL JRVR plus a self-help written work advice pack and usual care. WORKWELL will be delivered by occupational therapists provided with additional JRVR training from the research team. The primary outcome is presenteeism as measured using the Work Limitations Questionnaire-25. A comprehensive range of secondary outcomes of work, health, contextual factors and health resource use are included. Outcomes are measured at 6- and 12- months (with 12-months as the primary end-point). A multi-perspective within-trial cost-effectiveness analyses will also be conducted.
DISCUSSION


This trial will contribute to the evidence base for provision of JRVR to people with inflammatory arthritis. If JRVR is found to be effective in enabling people to keep working, the findings will support decision-making about provision of JRVR by rheumatology teams, therapy services and healthcare commissioners, and providing evidence of the effectiveness of JRVR and the economic impact of its implementation.
TRIAL REGISTRATION


Clinical Trials.Gov: NCT03942783 . Registered 08/05/2019 ( https://clinicaltrials.gov/ct2/show/NCT03942783 ); ISRCTN Registry: ISRCTN61762297 . Registered:13/05/2019 ( http://www.isrctn.com/ISRCTN61762297 ). Retrospectively registered.",2020,"Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations.","['Two hundred forty employed adults with rheumatoid arthritis, undifferentiated inflammatory arthritis or psoriatic arthritis (in secondary care), aged 18\u2009years or older with work instability', 'employed people with inflammatory arthritis', 'people with inflammatory arthritis']","['self-help written work advice pack plus usual care (control intervention); or WORKWELL JRVR plus a self-help written work advice pack and usual care', 'Job retention vocational rehabilitation (JRVR', 'written self-help work advice pack', 'JRVR', 'job retention vocational rehabilitation']",['presenteeism as measured using the Work Limitations Questionnaire-25'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1562028', 'cui_str': 'Undifferentiated inflammatory arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation'}]","[{'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",240.0,0.196277,"Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations.","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK. a.hammond@salford.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Sutton', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cotterill', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Woodbridge', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'School of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Radford', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Forshaw', 'Affiliation': 'Lancashire Clinical Trials Unit, University of Central Lancashire, Brook Building, Preston, Lancashire, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Verstappen', 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Marsden', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eden', 'Affiliation': 'Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Prior', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Culley', 'Affiliation': 'Patient research partner, Derbyshire, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Holland', 'Affiliation': 'Division of Health Research, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Walker-Bone', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Health and Work, University of Southampton, Southampton, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Hough', 'Affiliation': 'Rheumatology/ Occupational Therapy, St Helens and Knowsley Teaching Hospitals NHS Foundation Trust, St Helens Hospital, St Helens, Merseyside, UK.'}, {'ForeName': 'Terence W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ching', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03619-1']
2236,32912218,Effectiveness of a health-social partnership program for discharged non-frail older adults: a pilot study.,"BACKGROUND


Previous studies supporting discharged patients are hospital-based which admission criteria tend to include mainly those with complex needs and/or specific disease conditions. This study captured the service gap where these non-frail older patients might have no specific medical problem upon discharge but they might encounter residual health and social issues when returning home.
METHODS


Discharged community-dwelling non-frail older adults from an emergency medical ward were recruited and randomized into either intervention (n = 37) or control (n = 38) group. The intervention group received a 12-week complex interventions that included structured assessment, health education, goal empowerment, and care coordination supported by a health-social team. The control group received usual discharge care and monthly social call. The primary outcome was health-related quality of life (HRQoL). Secondary outcomes included activities of daily living (ADL), the presence of depressive symptoms, and the use of health services. The outcomes were measured at pre-intervention (T1) and at three months post-intervention (T2). The independent t-test or the Mann-Whitney U test was used to analyze the group differences in HRQoL, ADL, and presence of depressive symptoms according to the normality of data.
RESULTS


Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1. No significant differences were found in the control group.
CONCLUSIONS


Supporting self-care is necessary to enable community-dwelling non-frail older adults to be independent to the fullest extent possible in the community. The promising results found in this pilot study suggested that the integration of the health-social partnership into transitional care practice is effective and can be sustained in the community. Future studies can draw on these findings and maximize the integrated care quality during the transition phase.
TRIAL REGISTRATION


NCT04434742 (date: 17 June 2020, retrospectively registered).",2020,"RESULTS


Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1.","['Discharged community-dwelling non-frail older adults from an emergency medical ward', 'community-dwelling non-frail older adults', 'frail older patients', '17 June 2020, retrospectively registered', 'discharged non-frail older adults']","['health-social partnership program', 'usual discharge care and monthly social call', '12-week complex interventions that included structured assessment, health education, goal empowerment, and care coordination supported by a health-social team']","['HRQoL, ADL, and presence of depressive symptoms', 'activities of daily living', 'mental component scale of quality of life', 'health-related quality of life (HRQoL', 'presence of depressive symptoms', 'activities of daily living (ADL), the presence of depressive symptoms, and the use of health services']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0505116,"RESULTS


Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1.","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong. frances.wong@polyu.edu.hk.'}, {'ForeName': 'Jenny Sau Chun', 'Initials': 'JSC', 'LastName': 'Ngai', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}, {'ForeName': 'Shirley Yu Kan', 'Initials': 'SYK', 'LastName': 'Hung', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}, {'ForeName': 'Wah Chun', 'Initials': 'WC', 'LastName': 'Li', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}]",BMC geriatrics,['10.1186/s12877-020-01722-5']
2237,32912260,Leveraging family dynamics to increase the effectiveness of incentives for physical activity: the FIT-FAM randomized controlled trial.,"BACKGROUND


Insufficient physical activity is a global public health concern. Research indicates incentives can increase physical activity levels of children but has not tested whether incentives targeted at children can be leveraged to increase physical activity levels of their parents. This study evaluates whether a novel incentive design linking children's incentives to both their and their parent's physical activity levels can increase parent's physical activity.
METHODS


We conducted a two-arm, parallel, open-labelled randomized controlled trial in Singapore where parent-child dyads were randomly assigned to either (1) rewards to child contingent on child's physical activity (child-based) or (2) rewards to child contingent on both child's and parent's physical activity (family-based). Parents had to be English-speaking, computer-literate, non-pregnant, full-time employees, aged 25-65 years, and with a participating child aged 7-11 years. Parent-child dyads were randomized within strata (self-reported low vs high weekly physical activity) into study arms in a 1:1 ratio. Participants were given activity trackers to assess daily steps. The outcome of interest was the between-arm difference in the change from baseline in parent's mean steps/day measured by accelerometry at months 6 and 12 (primary endpoint).
RESULTS


Overall, 159 and 157 parent-child dyads were randomized to the child-based or family-based arms, respectively. Outcomes were evaluated on an intent-to-treat basis. At month 6, there was a 613 steps/day (95% CI: 54-1171) differential in favour of family-based parents. At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
CONCLUSIONS


Our findings suggest that novel incentive designs that take advantage of group dynamics may be effective. However, in this design, the effectiveness of the family-based incentive to increase parent's physical activity was not sustained through one year.
TRIAL REGISTRATION


NCT02516345 (ClinicalTrials.gov) registered on August 5, 2015.",2020,"At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
","['Parents had to be English-speaking, computer-literate, non-pregnant, full-time employees, aged 25-65\u2009years, and with a participating child aged 7-11\u2009years', 'Singapore where parent-child dyads', '159 and 157 parent-child dyads', 'Parent-child dyads']","[""1) rewards to child contingent on child's physical activity (child-based) or (2) rewards to child contingent on both child's and parent's physical activity (family-based""]","[""parent's physical activity"", 'physical activity levels']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.111529,"At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
","[{'ForeName': 'Eric Andrew', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Robyn Su May', 'Initials': 'RSM', 'LastName': 'Lim', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Dianne Stanton', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina Chapel Hill, 1700 Martin Luther King Jr. Boulevard #7426, Chapel Hill, NC, 27514, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Evenson', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina Chapel Hill, 1700 Martin Luther King Jr. Boulevard #7426, Chapel Hill, NC, 27514, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01018-2']
2238,32912290,Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial.,"BACKGROUND


Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets. Ibudilast, a phosphodiesterase inhibitor, has been advanced as a novel addiction pharmacotherapy that targets neurotrophin signaling and neuroimmune function.
METHODS


This study will conduct a 12-week, double-blind, placebo controlled randomized clinical trial of ibudilast (50 mg BID) for AUD treatment. We will randomize 132 treatment-seeking men and women with current AUD. We will collect a number of alcohol consumption outcomes. Primary among these is percent heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day, percent days abstinent, percent subjects with no heavy drinking days, and percent subjects abstinent, as well as measures of alcohol craving and negative mood. Additionally, participants will have the option to opt-in to a neuroimaging session in which we examine the effects of ibudilast on neural activation to psychosocial stress and alcohol cues. Finally, we will also collect plasma levels of proinflammatory markers, as well as subjective and biological (salivary cortisol) markers of stress response.
DISCUSSION


This study will further develop ibudilast, a safe and promising novel compound with strong preclinical and clinical safety data for AUD, and will probe biological mechanisms underlying the effects of Ibudilast on stress, neuroinflammation, and alcohol cue-reactivity and craving. If ibudilast proves superior to placebo in this study, it will set the stage for a confirmatory multi-site trial leading to FDA approval of a novel AUD treatment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03594435 ""Ibudilast for the Treatment of Alcohol Use Disorder"". Registered on 20 July 2018.",2020,The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets.,['132 treatment-seeking men and women with current AUD'],"['ibudilast (50\u2009mg BID', 'placebo']","['subjective and biological (salivary cortisol) markers of stress response', 'alcohol craving and negative mood', 'heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0123047', 'cui_str': 'ibudilast'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439505', 'cui_str': '/day'}]",,0.0733362,The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets.,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA. eburnette@g.ucla.edu.'}, {'ForeName': 'Wave-Ananda', 'Initials': 'WA', 'LastName': 'Baskerville', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}]",Trials,['10.1186/s13063-020-04670-y']
2239,32912614,RETRACTED: Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial.,,2020,,['clomiphene-resistant women with polycystic ovary syndrome'],"['metformin and clomiphene citrate', 'Letrozole']",[],"[{'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]",[],,0.189616,,"[{'ForeName': 'Hatem Abu', 'Initials': 'HA', 'LastName': 'Hashim', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shokeir', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1406']
2240,32912615,RETRACTED: Anastrozole or letrozole for ovulation induction in clomiphene-resistant women with polycystic ovarian syndrome: a prospective randomized trial.,,2020,,['clomiphene-resistant women with polycystic ovarian syndrome'],['Anastrozole or letrozole'],[],"[{'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]",[],,0.0622316,,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Mosbah', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Shady', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1407']
2241,32912616,RETRACTED: Clomiphene citrate or letrozole for ovulation induction in women with polycystic ovarian syndrome: a prospective randomized trial.,,2020,,['women with polycystic ovarian syndrome'],['Clomiphene citrate or letrozole'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]",[],,0.0407403,,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ibrahim Abdel', 'Initials': 'IA', 'LastName': 'Aal', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abulatta', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1408']
2242,32912617,RETRACTED: Clomiphene citrate or aromatase inhibitors for superovulation in women with unexplained infertility undergoing intrauterine insemination: a prospective randomized trial.,,2020,,['women with unexplained infertility undergoing intrauterine insemination'],['Clomiphene citrate or aromatase inhibitors'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}]",[],,0.0401751,,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Elnashar', 'Affiliation': 'Department of Obstetrics and Gynecology, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Totongy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1409']
2243,32920498,Ocrelizumab Treatment in Patients with Primary Progressive Multiple Sclerosis: Short-term Safety Results from a Compassionate Use Programme in Germany.,"OBJECTIVES


In January 2018, the European Union (EU) approved ocrelizumab in relapsing multiple sclerosis (RMS) and as the first disease-modifying therapy (DMT) for patients with primary progressive multiple sclerosis (PPMS) with efficacy proven in a phase 3 randomised controlled trial. Eleven months prior to the European regulatory approval, a compassionate use programme (CUP) made ocrelizumab available to 489 patients with PPMS in Germany, thereby for the first time providing a therapeutic option to patients with PPMS who could not participate in ocrelizumab studies. Here, we report real-world patient characteristics and short-term safety data of patients with PPMS treated with ocrelizumab in this CUP.
PATIENTS AND METHODS


This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU. Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres. The main exclusion criteria were current/recent treatment with other immune therapies and unresolved/chronic/active infections. Patients received methylprednisolone and an antihistamine before treatment with intravenous ocrelizumab in 6-month cycles. The first ocrelizumab dose was a 300 mg infusion followed by a second 300 mg infusion 2 weeks later; subsequent doses were delivered as a single 600 mg infusion. Adverse events were reported immediately.
RESULTS


Of 580 requests received from 104 centres, 525 patients met the eligibility criteria. Thirty-five patients did not participate due to withdrawal by the treating physician, and one due to death prior to treatment. A total of 489 patients received at least one 600 mg dose of ocrelizumab (administered as two 300 mg infusions) and 51 received a second dose. Due to termination of the CUP upon marketing authorisation, the maximum follow-up period was 12 months. Median patient age was 52 years (range: 24-73), and 49% were female. Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate. Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP. Nine serious adverse events and 70 non-serious adverse events were reported in 40 patients. Adverse event categories were generally consistent with the known safety profile of ocrelizumab; one patient had carry-over progressive multifocal leukoencephalopathy (PML) due to previous natalizumab treatment.
CONCLUSION


This CUP provides first real-world observations of ocrelizumab for the treatment of PPMS in a large patient cohort in Germany, supporting that ocrelizumab is generally well-tolerated in clinical practice. Physicians should be vigilant for early symptoms of PML, as to date, 9 PML cases that were all confounded have been reported in patients treated with ocrelizumab worldwide, with 8 carry-over cases from a prior DMT.",2020,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","['489 patients with PPMS in Germany', '489 patients', 'Patients with Primary Progressive Multiple Sclerosis', '525 patients met the eligibility criteria', 'patients with primary progressive multiple sclerosis (PPMS', 'Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres', 'patients with PPMS treated with ocrelizumab in this CUP', 'patients with PPMS who could not participate in ocrelizumab studies', 'Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP', 'Of 580 requests received from 104 centres', 'Median patient age was 52 years (range: 24-73), and 49% were female', 'This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU']","['ocrelizumab', 'methylprednisolone', 'intravenous ocrelizumab', 'glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate', 'antihistamine', 'Ocrelizumab']",['Adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C2718016', 'cui_str': 'Compassionate Use'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",489.0,0.02963,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Rauer', 'Affiliation': 'Klinik für Neurologie und Neurophysiologie, Universitätsklinikum Freiburg, Freiburg, Germany. Electronic address: sebastian.rauer@uniklinik-freiburg.de.'}, {'ForeName': 'Muna-Miriam', 'Initials': 'MM', 'LastName': 'Hoshi', 'Affiliation': 'Neurologische Klinik, Technische Universität München, Munich, Germany. Electronic address: muna.hoshi@ms-klinik.de.'}, {'ForeName': 'Refik', 'Initials': 'R', 'LastName': 'Pul', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Essen, Essen, Germany. Electronic address: refik.pul@uk-essen.de.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Wahl', 'Affiliation': 'Zentrum der Neurologie und Neurochirugie, Universitätsklinikum Frankfurt, Frankfurt, Germany. Electronic address: wahl@med.uni-frankfurt.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Jena, Jena, Germany. Electronic address: matthias.schwab@med.uni-jena.de.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'Jüdisches Krankenhaus Berlin, Berlin, Germany. Electronic address: judith.haas@jkb-online.de.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Ellrichmann', 'Affiliation': 'Klinik für Neurologie, St. Josef-Hospital, Bochum, Germany. Electronic address: gisa.ellrichmann@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Krumbholz', 'Affiliation': 'Department of Neurology & Stroke and Hertie-Institute for Clinical Brain Research, Eberhard Karl University of Tübingen, Tübingen, Germany. Electronic address: markus.krumbholz@uni-tuebingen.de.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Tackenberg', 'Affiliation': 'Zentrum für Neuroimmunologie, Universitätsklinikum Marburg, Marburg, Germany; F. Hoffmann-La Roche AG, Basel, Switzerland. Electronic address: tackenbb@staff.uni-marburg.de.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Saum', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: kai-uwe.saum@roche.com.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Buck', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: fabian.buck@roche.com.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Leemhuis', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: jost.leemhuis@roche.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kretschmann', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: anita.kretschmann@roche.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'Klinik für Neurologie, Medizinische Fakultät, Universitätsklinikum Düsseldorf, Düsseldorf, Germany. Electronic address: orhan.aktas@med.uni-duesseldorf.de.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106142']
2244,32920607,Effect of bleaching protocols on surface roughness and color change of high- and low-viscosity bulk-fill composite resins.,"The aim of this in vitro study was to evaluate the effect of bleaching protocols on the surface roughness (Ra), color change and surface micromorphology of a low-viscosity bulk-fill composite (Filtek Bulk Fill Flow, 3M ESPE), a highviscosity bulk-fill composite (Filtek Bulk Fill, 3M ESPE) and a conventional nanoparticulate composite resin (control) (Filtek Z350 XT, 3M ESPE). Forty samples of each composite (disks 5 mm in diameter and 2 mm thick) were randomly divided into four groups (n=10), according to bleaching protocol: a) 10% carbamide peroxide gel (Opalescence, Ultradent Products) (2 h/ day, for 14 days); b) 40% hydrogen peroxide gel (Opalescence Boost, Ultradent Products) (three bleaching sessions, once a week, 45 min/session); c) whitening rinse (Listerine Whitening Extreme, Johnson & Johnson) (2 min/day, for 14 days); and d) distilled water (control). The samples were submitted to triplicate readings (Ra and color [CIELAB parameters]) before and after contact with bleaching protocols. Micromorphology was analyzed in a scanning electron microscope (SEM). Ra and color parameters (ΔL, Δa, Δb and ΔE) were analyzed by generalized linear models (α=0.05). The Ra of the high-viscosity bulk-fill was significantly higher than that of the other composites (p<0.05). Ra increased significantly (p<0.05) and surface became more irregular (SEM analysis) in all the composite resins, regardless of the bleaching protocol (p<0.05). The high-viscosity bulk-fill composite resin group had significantly lower ΔE (p<0.05) than the nanoparticulate composite resin group immersed in distilled water. It was concluded that the characteristics of each resin significantly influenced the Ra more than the bleaching protocol. The high-viscosity bulk-fill resin presented minor color change.",2020,"Ra increased significantly (p<0.05) and surface became more irregular (SEM analysis) in all the composite resins, regardless of the bleaching protocol (p<0.05).",['Forty samples of each composite (disks 5 mm in diameter and 2 mm thick'],"['whitening rinse (Listerine Whitening Extreme, Johnson & Johnson', 'conventional nanoparticulate composite resin (control', 'hydrogen peroxide gel (Opalescence Boost, Ultradent Products) (three bleaching sessions', 'bleaching protocols', 'bleaching protocol: a) 10% carbamide peroxide gel (Opalescence, Ultradent Products']","['Ra of the high-viscosity bulk-fill', 'Ra', 'surface roughness (Ra), color change and surface micromorphology of a low-viscosity bulk-fill composite (Filtek Bulk Fill Flow, 3M ESPE), a highviscosity bulk-fill composite (Filtek Bulk Fill, 3M ESPE', 'surface roughness and color change of high- and low-viscosity bulk-fill composite resins']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0065081', 'cui_str': 'Listerine'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4505780', 'cui_str': 'Filtek Bulk Fill'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]",,0.0174133,"Ra increased significantly (p<0.05) and surface became more irregular (SEM analysis) in all the composite resins, regardless of the bleaching protocol (p<0.05).","[{'ForeName': 'Bruna G', 'Initials': 'BG', 'LastName': 'Tavares', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Fabiana Mg', 'Initials': 'FM', 'LastName': 'França', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Roberta T', 'Initials': 'RT', 'LastName': 'Basting', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Cecilia P', 'Initials': 'CP', 'LastName': 'Turssi', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Flavia Lb', 'Initials': 'FL', 'LastName': 'Amaral', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil. flbamaral@gmail.com.'}]",Acta odontologica latinoamericana : AOL,[]
2245,32920628,PTI-125 Reduces Biomarkers of Alzheimer's Disease in Patients.,"BACKGROUND


The most common dementia worldwide, Alzheimer's disease is often diagnosed via biomarkers in cerebrospinal fluid, including reduced levels of Aβ1-42, and increases in total tau and phosphorylated tau-181. Here we describe results of a Phase 2a study of a promising new drug candidate that significantly reversed all measured biomarkers of Alzheimer's disease, neurodegeneration and neuroinflammation. PTI-125 is an oral small molecule drug candidate that binds and reverses an altered conformation of the scaffolding protein filamin A found in Alzheimer's disease brain. Altered filamin A links to the α7-nicotinic acetylcholine receptor to allow Aβ42's toxic signaling through this receptor to hyperphosphorylate tau. Altered filamin A also links to toll-like receptor 4 to enable Aβ-induced persistent activation of this receptor and inflammatory cytokine release. Restoring the native shape of filamin A prevents or reverses filamin A's linkages to the α7-nicotinic acetylcholine receptor and toll-like receptor 4, thereby blocking Aβ42's activation of these receptors. The result is reduced tau hyperphosphorylation and neuroinflammation, with multiple functional improvements demonstrated in transgenic mice and postmortem Alzheimer's disease brain.
OBJECTIVES


Safety, pharmacokinetics, and cerebrospinal fluid and plasma biomarkers were assessed following treatment with PTI-125 for 28 days. Target engagement and mechanism of action were assessed in patient lymphocytes by measuring 1) the reversal of filamin A's altered conformation, 2) linkages of filamin A with α7-nicotinic acetylcholine receptor or toll-like receptor 4, and 3) levels of Aβ42 bound to α7-nicotinic acetylcholine receptor or CD14, the co-receptor for toll-like receptor 4.
DESIGN


This was a first-in-patient, open-label Phase 2a safety, pharmacokinetics and biomarker study.
SETTING


Five clinical trial sites in the U.S. under an Investigational New Drug application.
PARTICIPANTS


This study included 13 mild-to-moderate Alzheimer's disease patients, age 50-85, Mini Mental State Exam ≥16 and ≤24 with a cerebrospinal fluid total tau/Aβ42 ratio ≥0.30.
INTERVENTION


PTI-125 oral tablets (100 mg) were administered twice daily for 28 consecutive days.
MEASUREMENTS


Safety was assessed by electrocardiograms, clinical laboratory analyses and adverse event monitoring. Plasma levels of PTI-125 were measured in blood samples taken over 12 h after the first and last doses; cerebrospinal fluid levels were measured after the last dose. Commercial enzyme linked immunosorbent assays assessed levels of biomarkers of Alzheimer's disease in cerebrospinal fluid and plasma before and after treatment with PTI-125. The study measured biomarkers of pathology (pT181 tau, total tau and Aβ42), neurodegeneration (neurofilament light chain and neurogranin) and neuroinflammation (YKL-40, interleukin-6, interleukin-1β and tumor necrosis factor α). Plasma levels of phosphorylated and nitrated tau were assessed by immunoprecipitation of tau followed by immunoblotting of three different phospho-epitopes elevated in AD (pT181-tau, pS202-tau and pT231-tau) and nY29-tau. Changes in conformation of filamin A in lymphocytes were measured by isoelectric focusing point. Filamin A linkages to α7-nicotinic acetylcholine receptor and toll-like receptor 4 were assessed by immunoblot detection of α7-nicotinic acetylcholine receptor and toll-like receptor 4 in anti-filamin A immunoprecipitates from lymphocytes. Aβ42 complexed with α7-nicotinic acetylcholine receptor or CD14 in lymphocytes was also measured by co-immunoprecipitation. The trial did not measure cognition.
RESULTS


Consistent with the drug's mechanism of action and preclinical data, PTI-125 reduced cerebrospinal fluid biomarkers of Alzheimer's disease pathology, neurodegeneration and neuroinflammation from baseline to Day 28. All patients showed a biomarker response to PTI-125. Total tau, neurogranin, and neurofilament light chain decreased by 20%, 32% and 22%, respectively. Phospho-tau (pT181) decreased 34%, evidence that PTI-125 suppresses tau hyperphosphorylation induced by Aβ42's signaling through α7-nicotinic acetylcholine receptor. Cerebrospinal fluid biomarkers of neuroinflammation (YKL-40 and inflammatory cytokines) decreased by 5-14%. Biomarker effects were similar in plasma. Aβ42 increased slightly - a desirable result because low Aβ42 indicates Alzheimer's disease. This increase is consistent with PTI-125's 1,000-fold reduction of Aβ42's femtomolar binding affinity to α7-nicotinic acetylcholine receptor. Biomarker reductions were at least p ≤ 0.001 by paired t test. Target engagement was shown in lymphocytes by a shift in filamin A's conformation from aberrant to native: 93% was aberrant on Day 1 vs. 40% on Day 28. As a result, filamin A linkages with α7-nicotinic acetylcholine receptor and toll-like receptor 4, and Aβ42 complexes with α7-nicotinic acetylcholine receptor and CD14, were all significantly reduced by PTI-125. PTI-125 was safe and well-tolerated in all patients. Plasma half-life was 4.5 h and approximately 30% drug accumulation was observed on Day 28 vs. Day 1.
CONCLUSIONS


PTI-125 significantly reduced biomarkers of Alzheimer's disease pathology, neurodegeneration, and neuroinflammation in both cerebrospinal fluid and plasma. All patients responded to treatment. The magnitude and consistency of reductions in established, objective biomarkers imply that PTI-125 treatment counteracted disease processes and reduced the rate of neurodegeneration. Based on encouraging biomarker data and safety profile, approximately 60 patients with mild-to-moderate AD are currently being enrolled in a Phase 2b randomized, placebo-controlled confirmatory study to assess the safety, tolerability and efficacy of PTI-125.",2020,"Total tau, neurogranin, and neurofilament light chain decreased by 20%, 32% and 22%, respectively.","[""Alzheimer's Disease in Patients"", '60 patients with mild-to-moderate AD', ""13 mild-to-moderate Alzheimer's disease patients, age 50-85, Mini Mental State Exam ≥16 and ≤24 with a cerebrospinal fluid total tau/Aβ42 ratio ≥0.30"", 'Five clinical trial sites in the U.S. under an Investigational New Drug application', ""Alzheimer's disease brain""]","['placebo', 'PTI-125', 'filamin', 'oral tablets']","['pathology (pT181 tau, total tau and Aβ42), neurodegeneration (neurofilament light chain and neurogranin) and neuroinflammation (YKL-40, interleukin-6, interleukin-1β and tumor necrosis factor α', 'Cerebrospinal fluid biomarkers of neuroinflammation (YKL-40 and inflammatory cytokines', 'Altered filamin', 'Total tau, neurogranin, and neurofilament light chain', 'Biomarker reductions', 'safety, tolerability and efficacy of PTI-125', 'Safety, pharmacokinetics, and cerebrospinal fluid and plasma biomarkers', 'conformation of filamin A in lymphocytes', 'safe and well-tolerated', 'cerebrospinal fluid levels', 'rate of neurodegeneration', 'Plasma half-life', 'electrocardiograms, clinical laboratory analyses and adverse event monitoring', 'Plasma levels of phosphorylated and nitrated tau', 'Plasma levels of PTI-125']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0162778', 'cui_str': 'Investigational New Drug Applications'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0391072', 'cui_str': 'platinum (bis(acetato))(ethylenediamine) diiodide'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0060383', 'cui_str': 'Filamin'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027746', 'cui_str': 'Nerve degeneration'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0083727', 'cui_str': 'P17 Protein Kinase C Substrate'}, {'cui': 'C0528649', 'cui_str': 'CHI3L1 protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0060383', 'cui_str': 'Filamin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0391072', 'cui_str': 'platinum (bis(acetato))(ethylenediamine) diiodide'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}, {'cui': 'C1612831', 'cui_str': '280 kDa Actin-Binding Protein'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}]",13.0,0.192146,"Total tau, neurogranin, and neurofilament light chain decreased by 20%, 32% and 22%, respectively.","[{'ForeName': 'H-Y', 'Initials': 'HY', 'LastName': 'Wang', 'Affiliation': 'Lindsay H. Burns, PhD, Cassava Sciences, Inc., 7801 N. Capital of Texas Hwy, Ste. 260, Austin, TX 78746, Phone: 512-501-2484, Email: lburns@cassavasciences.com.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Pei', 'Affiliation': ''}, {'ForeName': 'K-C', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lopez-Brignoni', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nikolov', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Crowley', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Marsman', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Barbier', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Friedmann', 'Affiliation': ''}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Burns', 'Affiliation': ''}]",The journal of prevention of Alzheimer's disease,['10.14283/jpad.2020.6']
2246,32920641,Multidose Priming and Delayed Boosting Improve PfSPZ Vaccine Efficacy against Heterologous P. falciparum Controlled Human Malaria Infection.,"BACKGROUND


A live-attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) vaccine (PfSPZ Vaccine) has shown up to 100% protection against controlled human malaria infection (CHMI) using homologous parasites (same Pf strain as in the vaccine). Using a more stringent CHMI, with heterologous parasites (different Pf strain), we assessed the impact of higher PfSPZ doses, a novel multi-dose prime regimen, and a delayed vaccine boost upon vaccine efficacy.
METHODS


Four groups of 15 healthy, malaria-naïve adults were immunized. Group (Grp) 1 received five doses of 4.5x10 5 PfSPZ (days 1, 3, 5, 7; week 16). Grps 2, 3 and 4 received three doses (weeks 0, 8, 16) with Gp 2 receiving 9.0×10 5/dose, Grp 3 receiving 18.0×10 5/dose, and Grp 4 receiving 27.0×10 5 for dose 1 and 9.0×10 5 for doses 2 and 3. VE was assessed by heterologous CHMI after 12 or 24 weeks. Volunteers not protected at 12 weeks were boosted prior to repeat CHMI at 24 weeks.
RESULTS


At 12-week CHMI, 6/15 (40%) Group 1 (P=0.04), 3/15 (20%) Group 2 vs. 0/8 controls remained aparasitemic. At 24-week CHMI, 3/13 (23%) Group 3, 3/14 (21%) Group 4 vs. 0/8 controls remained aparasitemic (Groups 2-4, VE not significant). Post-boost, 9/14 (64%) vs. 0/8 controls remained aparasitemic (3/6 Group 1, P=0.025; 6/8 Group 2, P=0.002).
CONCLUSIONS


Four stacked, priming injections (multi-dose priming) showed 40% VE against heterologous CHMI, while dose escalation of PfSPZ using single dose priming was not significantly protective. Boosting unprotected subjects improved VE at 24 weeks to 64%.",2020,"vs. 0/8 controls remained aparasitemic (3/6 Group 1, P=0.025; 6/8 Group 2, P=0.002).
","['Four groups of 15 healthy, malaria-naïve adults were immunized']","['4.5x10 5 PfSPZ', 'PfSPZ', 'live-attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) vaccine (PfSPZ Vaccine']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.0563107,"vs. 0/8 controls remained aparasitemic (3/6 Group 1, P=0.025; 6/8 Group 2, P=0.002).
","[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Singer', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Berry', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Sharina', 'Initials': 'S', 'LastName': 'Reyes', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Sumana', 'Initials': 'S', 'LastName': 'Chakravarty', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Billingsley', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Gunasekera', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Manoj', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Laurens', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'W Preston', 'Initials': 'WP', 'LastName': 'Church', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Lindsey S', 'Initials': 'LS', 'LastName': 'Garver Baldwin', 'Affiliation': 'Pharmaceutical Systems Project Management Office (PSPMO) U.S. Army Medical and Materiel Development Activity (USAMMDA), Fort Detrick, MD.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sedegah', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Glenna', 'Initials': 'G', 'LastName': 'Banania', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Harini', 'Initials': 'H', 'LastName': 'Ganeshan', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Ivelese', 'Initials': 'I', 'LastName': 'Guzman', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Anatalio', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Arnel', 'Initials': 'A', 'LastName': 'Belmonte', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Ozemoya', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Belmonte', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Villasante', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Protein Potential LLC, Rockville, MD.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria Inc., Rockville, MD.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Epstein', 'Affiliation': 'Naval Medical Research Center Malaria Department, Silver Spring, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1294']
2247,32920646,"ERRATUM FOR ""Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial"".",,2020,,['Acromegaly'],['Oral Octreotide'],[],"[{'cui': 'C0001206', 'cui_str': 'Acromegaly'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}]",[],,0.018058,,[],The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa637']
2248,32911306,Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study.,"BACKGROUND


In the phase 3 TOWER core study (NCT00751881), the efficacy and safety of teriflunomide compared with placebo were demonstrated in patients with relapsing forms of multiple sclerosis (RMS). Here, the long-term safety and efficacy outcomes from the TOWER extension study (NCT00751881) are reported.
METHODS


All patients who entered the extension (N = 751) were assigned to teriflunomide 14 mg and assessed for long-term safety and efficacy.
RESULTS


Of 751 patients in the TOWER extension study, 253, 265, and 233 patients received placebo/teriflunomide 14 mg, teriflunomide 7 mg/14 mg, and teriflunomide 14 mg/14 mg, respectively. Median teriflunomide exposure was 4.25 years (maximum 6.3 years). The overall frequency of adverse events (AEs) was comparable across treatment groups, but a higher proportion of patients in the teriflunomide 7 mg/14 mg (12.4%) and 14 mg/14 mg (12.4%) groups had serious AEs compared with the placebo/teriflunomide 14 mg group (6.4%). Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively). The incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy) were low and comparable across treatment arms. Disability worsening and adjusted annualized relapse rates were low and stable over time, and mean Expanded Disability Status Scale scores were unchanged over time, for all treatment groups.
CONCLUSION


In the TOWER extension study, the efficacy of teriflunomide 14 mg was maintained in patients with RMS. No new or unexpected AEs were observed with teriflunomide treatment, supporting a safety profile in the extension that was consistent with the core trial. These findings support the positive benefit:risk profile of teriflunomide as a long-term immunomodulatory therapy.",2020,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","['All patients who entered the extension', '751 patients in the TOWER extension study, 253, 265, and 233 patients received', 'patients with relapsing forms of multiple sclerosis (RMS', 'patients with relapsing multiple sclerosis', 'patients with RMS']","['placebo/teriflunomide 14\xa0mg, teriflunomide', 'placebo', 'placebo/teriflunomide', 'teriflunomide']","['incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy', 'efficacy and safety', 'Disability worsening and adjusted annualized relapse rates', 'Median teriflunomide exposure', 'mean Expanded Disability Status Scale scores', 'Alanine aminotransferase increase and hair thinning', 'overall frequency of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3497716', 'cui_str': 'teriflunomide 14 MG'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0020678', 'cui_str': 'Hypotrichosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",751.0,0.0571361,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","[{'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, 5 East 98th Street-Box 1138, New York, NY, 10029, United States. Electronic address: aaron.miller@mssm.edu.'}, {'ForeName': 'Tomas P', 'Initials': 'TP', 'LastName': 'Olsson', 'Affiliation': 'Neuroimmunology Unit, Department of Clinical Neuroscience, Karolinska Institutet, Center for Molecular Medicine, L8:04, Karolinska Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), 6431 Fannin Street, Houston, TX, 77030, United States.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland.'}, {'ForeName': 'Xueqiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Neurology, Hospital of Sun Yat-Sen University, 107 Yan Jiang West Road, Guangzhou, China.'}, {'ForeName': 'Xianhao', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Beijing Hospital, No. 1 Dahua Road, Beijing, China.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Lublin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chavin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Delhay', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Purvis', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The Ottawa Hospital Ontario, 501 Smyth Road, Box 601, Ottawa, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102438']
2249,32911319,"A randomized pilot study assessing the acceptability of rapid point-of-care hepatitis C virus (HCV) testing among male inmates in Montreal, Canada.","BACKGROUND


The Oraquick Ⓡ  fingerprick point-of-care hepatitis C virus antibody (HCV-Ab) test is favoured to venipuncture among people who inject drugs; however, its acceptability in prison populations is unknown. We aimed to compare the acceptability of the Oraquick Ⓡ  versus standard venipuncture among people in prison.
METHODS


From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation. The remaining 78 were randomized 1:1 to opt-out HCV-Ab screening with OraQuick Ⓡ  or venipuncture (n = 39 each). Acceptability was determined by the proportion accepting to undergo screening.
RESULTS


The majority of participants (median age 33 years) reported a history of drug use (76%; 8% injection drug use); 47% perceived their HCV risk to be moderate/high. All inmates randomized to Oraquick Ⓡ  accepted testing while 87% accepted venipuncture. Among those who accepted Oraquick Ⓡ  vs. venipuncture, 100% vs. 97% were satisfied with the test, 97% vs. 94% would recommend the same test, and 100% vs. 76% would choose the same test again.
CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.",2020,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[""From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation"", 'people in prison', 'male inmates in Montreal, Canada', 'Adult incarcerated men in Canada']","['rapid point-of-care hepatitis C virus (HCV', 'venipuncture', 'Ⓡ  or venipuncture', 'HCV-Ab screening with OraQuick', 'Oraquick Ⓡ  versus standard venipuncture']",['Acceptability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",280.0,0.0431789,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: nadine.kronfli@mcgill.ca.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Dussault', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chalifoux', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hasmig', 'Initials': 'H', 'LastName': 'Kavoukian', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; CIHR Canadian HIV Trials Network, Vancouver, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102921']
2250,32912292,Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty: study protocol for a prospective randomised controlled trial.,"BACKGROUND


Robotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA). Preoperative pelvic computerised tomography (CT) scans will be used to create patient-specific, virtual, three-dimensional reconstructions for surgical planning in both treatment groups.
METHODS AND ANALYSIS


This prospective randomised controlled trial will include 60 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to CO THA (control group) or RO THA (investigation group) at a ratio of 1:1 using an online random number generator. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to the accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. Intention to treat relates to the allocated treatment (CO THA or RO THA), and per-protocol refers to the actual treatment received by the patient. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Bromley Research Ethics Committee, UK. The study is sponsored by University College London, UK.
DISCUSSION


This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CT-planned CO THA versus CT-planned RO THA. The findings of this study will enable an improved understanding of the differences in CO THA versus RO THA with respect to patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04095845 . Registered on 19 September 2019.",2020,Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups.,"['University College London, UK', '60 patients with symptomatic hip osteoarthritis undergoing primary THA', 'total hip arthroplasty']","['CT-planned CO THA versus CT-planned RO THA', 'Preoperative pelvic computerised tomography (CT) scans', 'CO THA (control group) or RO THA', 'Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty', 'Robotic-arm assisted surgery', 'conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA']","['patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications', 'accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications', 'accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",60.0,0.149578,Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups.,"[{'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Kayani', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK. babar.kayani@gmail.com.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Konan', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Tahmassebi', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Ayuob', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Fares S', 'Initials': 'FS', 'LastName': 'Haddad', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}]",Trials,['10.1186/s13063-020-04702-7']
2251,32912298,Effect of acupuncture on women with poor ovarian response: a study protocol for a multicenter randomized controlled trial.,"BACKGROUND


Poor ovarian response (POR), a manifestation of low ovarian reserve and ovarian aging, leads to a significant reduction in the pregnancy rate after in vitro fertilization-embryo transfer. Acupuncture has increasingly been used to improve the ovarian reserve. The purpose of this study will be to evaluate the effect of acupuncture on increasing the number of retrieved oocytes after controlled ovarian hyperstimulation in women with POR.
METHODS


This will be a multicenter randomized controlled trial. A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation. The primary outcome will be the number of retrieved oocytes. The secondary outcomes will be antral follicle counts, serum levels of anti-Müllerian hormone, basal serum levels of follicle stimulating hormone, luteinizing hormone and estradiol levels, scores from the self-rating anxiety scale, fertilization rates, cleavage rates, available embryo rates, and high-quality embryo rates. The safety of acupuncture will also be assessed.
DISCUSSION


The results of this trial will help to determine the effectiveness of acupuncture in the treatment of POR. This may provide a new treatment option for patients with POR and their physicians.
TRIAL REGISTRATION


AMCTR-IPR-18000198 . Registered on 10 August 2018.",2020,A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation.,"['women with POR', 'women with poor ovarian response', '140 women with POR', 'patients with POR and their physicians']","['Acupuncture', 'acupuncture']","['antral follicle counts, serum levels of anti-Müllerian hormone, basal serum levels of follicle stimulating hormone, luteinizing hormone and estradiol levels, scores from the self-rating anxiety scale, fertilization rates, cleavage rates, available embryo rates, and high-quality embryo rates', 'number of retrieved oocytes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]",140.0,0.369149,A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation.,"[{'ForeName': 'Huanfang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Chensi', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Tongsheng', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': 'Shanxi Provincial Hospital of Chinese Medicine, Taiyuan, Shanxi, China.'}, {'ForeName': 'Huidan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Shandong University Reproductive Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen Memorial Hospital of the Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Lanzhou University First Hospital, Lanzhou, Gansu, China.'}, {'ForeName': 'Cuilian', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Huazhong University of Science and Technology Reproductive Medicine Center of Tongji Medical College, Wuhan, Hubei, China.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Tong', 'Affiliation': 'Shanghai Shuguang Hospital, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'East Region Military Command General Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Luoyang Women and Children Health Care Center, Luoyang, Henan, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Mingzhao', 'Initials': 'M', 'LastName': 'Hao', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Yaqian', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Yigong', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China. fangyigong@163.com.'}, {'ForeName': 'Baoyan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. liuby5505@139.com.'}]",Trials,['10.1186/s13063-020-04690-8']
2252,32912305,A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol.,"BACKGROUND


Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA.
METHODS


The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up.
DISCUSSION


This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient's status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04263974 . Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.",2020,Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment).,"['patients with a chronic rheumatic disease', 'patients with hand RA', 'Fifty-eight participants with hand RA', 'patients with hand rheumatoid arthritis']","['therapeutic exercise and education', 'smartphone app (CareHand), using hand exercises and educational advices', 'Control intervention', 'smartphone app, which provides individualized exercise programs, self-management, and educational strategies', 'control group (conventional treatment']","['overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ', 'self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer', 'overall function, pain intensity, stiffness, and grip and pinch strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}]",58.0,0.081956,Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment).,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodríguez-Sánchez-Laulhé', 'Affiliation': 'Andalusian Public Foundation for the Management of Health Research of Seville FISEVI, Seville, Spain.'}, {'ForeName': 'Luis Gabriel', 'Initials': 'LG', 'LastName': 'Luque-Romero', 'Affiliation': 'Research Unit, Distrito Sanitario Aljarafe-Sevilla Norte, Servicio Andaluz de Salud, Seville, Spain. luqueluis2@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Blanquero', 'Affiliation': 'Physiotherapy Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Suero-Pineda', 'Affiliation': 'Physiotherapy Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Biscarri-Carbonero', 'Affiliation': 'Research Unit, Distrito Sanitario Aljarafe-Sevilla Norte, Servicio Andaluz de Salud, Seville, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Barrero-García', 'Affiliation': 'Research Unit, Distrito Sanitario Aljarafe-Sevilla Norte, Servicio Andaluz de Salud, Seville, Spain.'}, {'ForeName': 'Alberto Marcos', 'Initials': 'AM', 'LastName': 'Heredia-Rizo', 'Affiliation': 'Physiotherapy Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}]",Trials,['10.1186/s13063-020-04713-4']
2253,32912308,Using qualitative research to explore intervention mechanisms: findings from the trial of the Learning Together whole-school health intervention.,"BACKGROUND


This study reports on qualitative research conducted within a randomised controlled trial to explore possible intervention mechanisms. It focuses on the 'Learning Together' whole-school intervention delivered in secondary schools in England from 2014 to 2017 aiming to prevent bullying and aggression and improve student health. Intervention schools received staff training in restorative practice, a social and emotional learning curriculum, and an external facilitator and manual to convene and run a student/staff action group tasked with coordinating the intervention, focusing this on local needs.
METHODS


Informed by realist approaches to evaluation, we analysed qualitative data to explore intervention mechanisms and how these might interact with school contexts to generate outcomes. Qualitative analysis drew on 45 interviews and 21 focus groups across three case-study schools and employed thematic content analysis to explore how intervention resources were taken up and used by local actors, how participants described the intervention mechanisms that then ensued, and how these might have generated beneficial outcomes.
RESULTS


The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
CONCLUSIONS


Our analysis provides in-depth exploration of possible mechanisms and the contextual contingencies associated with these, allowing refinement of the initial intervention theory of change.
TRIAL REGISTRATION


ISRCTN registry 10751359 . Registered on 11 March 2014.",2020,"The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
",[],"['staff training in restorative practice, a social and emotional learning curriculum, and an external facilitator and manual to convene and run a student/staff action group tasked with coordinating the intervention, focusing this on local needs']",[],[],"[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",[],,0.0292106,"The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK. emily.warren@lshtm.ac.uk.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Meledez-Torres', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Viner', 'Affiliation': 'UCL Institute of Child Health, London, WC1N 1EH, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}]",Trials,['10.1186/s13063-020-04688-2']
2254,32912514,"Adherence to study drug in a stroke prevention trial""?>.","OBJECTIVE


Standards for reporting and analyzing adherence to medical therapy have recently improved due to international consensus efforts. If applied to clinical trial research in patients with stroke, these improvements have the potential to identify when in the sequence of trial operations participants are at risk for non-adherence and opportunities to safeguard adherence.
METHODS


We analyzed three phases of adherence according to the European Society for Patient Adherence, COMpliance, and Persistence (ESPACOMP) Medication Adherence Reporting Guideline (EMERGE) taxonomy in the Insulin Resistance Intervention after Stroke (IRIS) trial: initiation (did patient start drug), implementation (did patient take a drug holiday, defined as temporary cessation lasting ≥14 days), and persistence (did patient prematurely and permanently discontinue drug). IRIS was a randomized, placebo controlled, double-blind trial testing pioglitazone to prevent stroke or myocardial infarction in patients with a recent ischemic stroke or transient ischemic attack. Adherence was classified by self-report. Researchers used coaching algorithms to seek adherence recovery if participants went off drug.
RESULTS


During 2005-2013, 3876 participants were enrolled from 179 sites in seven countries and followed for a mean of 4.8 years. Less than 1% of participants in each group did not initiate study drug. 20% of patients assigned to pioglitazone and 17% assigned to placebo took at least one drug holiday. 36% and 30%, respectively, discontinued the study drug prematurely with or without a prior holiday. The risk for stopping the study drug (temporarily or permanently) in the first year after randomization was twice the risk in each of the subsequent four years. This was true both for patients assigned to active therapy and placebo. More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one. In years two through five, rates of discontinuation were similar in the two treatment groups. The difference in rates during year one was the result of adverse effects related to the active study drug, pioglitazone. During the remainder of the trial, the attribution of discontinuations to adverse effects potentially related to pioglitazone was reduced but still higher in those assigned to active drug. Other reasons for discontinuation were similar between treatment groups and were largely unrelated to pharmacodynamic effects of the study drug. Rates of discontinuation varied widely among research sites.
CONCLUSION


Patients in a drug trial for stroke prevention are at greatest risk for premature drug discontinuation early after randomization. Reasons for discontinuation change over time. Variable discontinuation rates among sites suggests that adherence can be improved by using best practices from high-performing sites.",2020,"More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one.","['participants went off drug', 'During 2005-2013, 3876 participants were enrolled from 179 sites in seven countries and followed for a mean of 4.8 years', 'patients with a recent ischemic stroke or transient ischemic attack', 'patients with stroke']","['placebo', 'pioglitazone']","['stroke or myocardial infarction', 'rates of discontinuation']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",3876.0,0.437434,"More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one.","[{'ForeName': 'Akshatha', 'Initials': 'A', 'LastName': 'Kiran', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: Akshatha.kiran@yale.edu.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Viscoli', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: catherine.viscoli@yale.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Furie', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, United States. Electronic address: kfurie@lifespan.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gorman', 'Affiliation': 'Maine Medical Center, Portland, ME, United States.'}, {'ForeName': 'Walter N', 'Initials': 'WN', 'LastName': 'Kernan', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: walter.kernan@yale.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105048']
2255,32912959,Correction: Study protocol for the POPART study - Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial.,,2020,,['Preterm infants'],['Prophylactic Oropharyngeal surfactant'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]",[],,0.185543,,[],BMJ open,['10.1136/bmjopen-2019-035994corr1']
2256,32913532,"Effects of aerobic and strength training on aerobic capacity, muscle strength, and gene expression of lymphomonocytes in patients with stable CAD.","This study examined the effectiveness, suitability, and safety of a mixed interval-type aerobic and strength training program (MIAST) on physical fitness in patients with stable coronary artery disease (CAD) without history of myocardial infarction (MI). Twenty-three patients with stable CAD were randomly assigned to a MIAST (n = 12; mean age 58.6 years) or control (n = 11; 63.3 years) group. The MIAST group participated in the progressive training program twice a week for 21 weeks. Peak oxygen uptake (VO 2peak ), workload, and exercise time were measured as were maximal muscle strength, serum lipids, glucose concentration, and the cross-sectional area (CSA) of knee extensors. The safety and suitability of the program were assessed by wireless electrocardiogram (ECG) monitoring and exercise diaries. VO 2peak  (6.9%; P < 0.05) and exercise time (11.2%; P < 0.05) improved significantly after 12 weeks of training in the MIAST group compared to the control group. Muscle strength (19.9%; P < 0.05) and CSA (2.2%; P < 0.05) increased, and serum lipids and blood glucose tended to decrease after the training. The successful training program (increase in maximal oxygen uptake) increased the gene expression of oxygen metabolism and decreased the gene expression of inflammation pathways in lymphomonocytes. The MIAST program, including interval-type aerobic and strength training, was safe, did not cause any adverse effects, and led to significant improvements in physical fitness in patients with stable CAD.",2020,"The MIAST program, including interval-type aerobic and strength training, was safe, did not cause any adverse effects, and led to significant improvements in physical fitness in patients with stable CAD.","['patients with stable CAD', 'patients with stable coronary artery disease (CAD) without history of myocardial infarction (MI', 'Twenty-three patients with stable CAD', 'n = 12; mean age 58.6 years) or control (n = 11; 63.3 years) group']","['mixed interval-type aerobic and strength training program (MIAST', 'aerobic and strength training', 'MIAST']","['CSA', 'gene expression of oxygen metabolism', 'exercise time', 'physical fitness', 'Peak oxygen uptake (VO 2peak ), workload, and exercise time', 'aerobic capacity, muscle strength, and gene expression of lymphomonocytes', 'maximal muscle strength, serum lipids, glucose concentration, and the cross-sectional area (CSA) of knee extensors', 'serum lipids and blood glucose', 'wireless electrocardiogram (ECG) monitoring and exercise diaries', 'Muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",23.0,0.0126728,"The MIAST program, including interval-type aerobic and strength training, was safe, did not cause any adverse effects, and led to significant improvements in physical fitness in patients with stable CAD.","[{'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Lehti', 'Affiliation': 'Faculty of Sport and Health Science, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Valkeinen', 'Affiliation': 'Finnish Institute for Health and Welfare Helsinki, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Perhonen', 'Affiliation': 'Suomen Terveystalo Oyj Jyväskylä, Finland.'}, {'ForeName': 'Mirva', 'Initials': 'M', 'LastName': 'Rottensteiner', 'Affiliation': 'Faculty of Sport and Health Science, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Pullinen', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Rauno', 'Initials': 'R', 'LastName': 'Pietiläinen', 'Affiliation': 'Lapland University of Applied Sciences Kemi, Finland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Nyman', 'Affiliation': 'Central Hospital of Central Finland Jyväskylä, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Vehkaoja', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University Tampere, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kainulainen', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Science, University of Jyväskylä Jyväskylä, Finland.'}]",American journal of translational research,[]
2257,32913533,"The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial.","This study aimed to evaluate the efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy. In this multicentered, blinded, randomized, active-controlled, non-inferior phase III trial, 384 eligible patients who were about to undergo colonoscopy were randomized as a ratio of 1:1 into remimazolam and propofol group. Procedure success was assessed and defined as the completion of colonoscopy without administration of rescue sedative agent or more than 5 top-ups of trial drug in any 15 minute-period after initial administration of trial drug. Sedation quality was evaluated by Modified Observer's Assessment of Alertness/Sedation score. Treatment-emergent adverse events were recorded. Procedure success rate was 96.91% (188/194) in remimazolam group and 100% (190/190) in propofol group, and the difference in rate was -3.09% with 95% confidence interval (CI) of -5.53%~-0.66%. Since the lower limit of 95% CI was greater than the non-inferiority margin of -8.00%, the efficacy of remimazolam tosylate was non-inferior to propofol. Besides, induction time of sedation was increased ( P <0.001), while hypotension and respiratory depression was decreased in remimazolam group compared to propofol group; however, time to fully alert ( P >0.05) or time to discharge ( P >0.05) were unchanged. For safety assessment, total treatment-emergent adverse events were decreased in remimazolam group compared to propofol group ( P <0.001); specifically, administration site pain ( P <0.001), increased bilirubin ( P =0.019), decreased respiratory rate ( P <0.001) and decreased SpO 2  ( P <0.001) were less frequent in remimazolam group compared with propofol group. In conclusion, remimazolam tosylate is non-inferior in sedation efficacy while safer than propofol in patients undergoing colonoscopy.",2020,"Besides, induction time of sedation was increased ( P <0.001), while hypotension and respiratory depression was decreased in remimazolam group compared to propofol group; however, time to fully alert ( P >0.05) or time to discharge ( P >0.05) were unchanged.","['patients undergoing colonoscopy', '384 eligible patients who were about to undergo colonoscopy']","['propofol', 'remimazolam tosylate versus propofol', 'remimazolam and propofol']","['respiratory rate', 'bilirubin', 'efficacy and safety', 'hypotension and respiratory depression', 'time to discharge', 'Procedure success', 'Sedation quality', 'safety assessment, total treatment-emergent adverse events', 'Alertness/Sedation score', 'administration site pain', 'induction time of sedation', 'Procedure success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C3874886', 'cui_str': 'Is about'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521491', 'cui_str': 'Application site pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",384.0,0.144003,"Besides, induction time of sedation was increased ( P <0.001), while hypotension and respiratory depression was decreased in remimazolam group compared to propofol group; however, time to fully alert ( P >0.05) or time to discharge ( P >0.05) were unchanged.","[{'ForeName': 'Shaohui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Shanfu', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University Beijing 100050, China.'}, {'ForeName': 'Anshi', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University Beijing 100020, China.'}, {'ForeName': 'Xiaoju', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Yijishan Hospital of Wannan Medical College Wuhu 241001, Anhui, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Xi'an Jiaotong University Xi'an 710061, Shanxi, China.""}, {'ForeName': 'Jianrui', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': ""Department of Anesthesiology, The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an 710004, Shanxi, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou 510120, Guangdong, China.'}, {'ForeName': 'Yonghao', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, General Hospital of Tianjin Medical University Tianjin 300052, China.'}, {'ForeName': 'Dengbin', 'Initials': 'D', 'LastName': 'Ai', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital Qingdao 266011, Shandong, China.'}, {'ForeName': 'Ailin', 'Initials': 'A', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Tongji Medical College, Huazhong University of Sciences Technology Wuhan 430030, Hubei, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University Chongqing 400042, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, General Hospital of Shenyang Military Region, PLA Shenyang 110000, Liaoning, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University Guiyang 550000, Guizhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, Anhui Provincial Hospital Hefei 230001, Anhui, China.'}, {'ForeName': 'Xude', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University Xi'an 710038, Shanxi, China.""}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Lianyungang Lianyungang 222061, Jiangsu, China.""}, {'ForeName': 'Jiaqiang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Henan Provincial People's Hospital Zhengzhou 450003, Henan, China.""}]",American journal of translational research,[]
2258,32913549,Alignment results of infrared computer-assisted navigation of total knee arthroplasty for end-stage knee osteoarthritis.,"OBJECTIVE


Total knee arthroplasty (TKA) is one of the most conventional surgeries used to solve dyskinesia caused by knee joint degeneration; however, ambiguous prosthesis position and angle after TKA can cause serious complications. This study evaluated the outcomes of infrared computer-assisted navigation (ICAN) of TKA for end-stage knee osteoarthritis.
METHODS


Forty-six end-stage knee osteoarthritis patients who underwent TKA were randomly divided into computer-assisted orthopedic surgery (CAOS) (n = 23) and non-CAOS (n = 23) groups. The intraoperative conditions, postoperative complications, soft tissue balancing, functional scores, and X-ray data were compared between groups.
RESULTS


The CAOS group showed longer surgery time and higher range of motion than the non-CAOS group. No significant differences in American Knee Society Score (AKSS) and Oxford Knee Score were observed between the two groups. Compared to those in the non-CAOS group, the error of the lower limb line, angle of soft tissue balancing, separation of soft tissue, and angular deviation (α, β, γ, δ) of the implants were much lower in the CAOS group.
CONCLUSION


The ICAN system for TKA surgery was associated with less intraoperative blood loss and suitable position and angle in patients with end-stage knee osteoarthritis.",2020,The ICAN system for TKA surgery was associated with less intraoperative blood loss and suitable position and angle in patients with end-stage knee osteoarthritis.,"['patients with end-stage knee osteoarthritis', 'Forty-six end-stage knee osteoarthritis patients who underwent TKA', 'total knee arthroplasty for end-stage knee osteoarthritis']","['infrared computer-assisted navigation', 'Total knee arthroplasty (TKA', 'infrared computer-assisted navigation (ICAN) of TKA', 'computer-assisted orthopedic surgery (CAOS) (n = 23) and non-CAOS']","['longer surgery time and higher range of motion', 'error of the lower limb line, angle of soft tissue balancing, separation of soft tissue, and angular deviation (α, β, γ, δ', 'intraoperative conditions, postoperative complications, soft tissue balancing, functional scores, and X-ray data', 'intraoperative blood loss and suitable position and angle', 'American Knee Society Score (AKSS) and Oxford Knee Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}]",,0.020452,The ICAN system for TKA surgery was associated with less intraoperative blood loss and suitable position and angle in patients with end-stage knee osteoarthritis.,"[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Guangxiang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Yuanshi', 'Initials': 'Y', 'LastName': 'She', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Xiangxin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}]",American journal of translational research,[]
2259,32913569,"Simulated root canals preparation time, comparing ProTaper Next and WaveOne Gold systems, performed by an undergraduate student.","Background


The aim of this study was to compare the WaveOne Gold and ProTaper Next systems regarding the time spent preparing simulated canals performed by an inexperienced student.
Material and Methods


0 simulated L-shaped canals were randomly divided into two groups (n = 40) and numbered in order of instrumentation. Canals were instrumented with WaveOne Gold (group 1) and ProTaper Next (group 2) systems. The effective instrumentation time and the number of instrumentation cycles were recorded. All procedures were performed by the same operator. Statistical analysis was obtained by the Mann - Whitney, Kruskal - Wallis test with significance of  p <0.05.
Results


There were no statistically significant differences regarding the mean instrumentation time between the two instrumentation systems. The instrumentation time decreased over the experimental period, regardless of the technique used.
Conclusions


Through a short learning curve, an inexperienced operator can prepare simulated canals in a very predictable time. Time spent was similar in a multi-file instrument system (ProTaper Next) and a single-file system (WaveOne Gold).  Key words: Dental education, endodontics, preclinical, root canal preparation, undergraduate.",2020,There were no statistically significant differences regarding the mean instrumentation time between the two instrumentation systems.,[],"['WaveOne Gold (group 1) and ProTaper Next', 'Material and Methods\n\n\n0 simulated L-shaped canals']","['mean instrumentation time', 'effective instrumentation time and the number of instrumentation cycles', 'instrumentation time', 'Time spent']",[],"[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",40.0,0.0288529,There were no statistically significant differences regarding the mean instrumentation time between the two instrumentation systems.,"[{'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'DMD, MDent, Faculty of Dental Medicine of University of Porto, Porto, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Ferreira', 'Affiliation': 'DMD, MDent, Faculty of Dental Medicine of University of Porto, Porto, Portugal.'}, {'ForeName': 'Ana-Cristina', 'Initials': 'AC', 'LastName': 'Braga', 'Affiliation': 'PhD, Department of Production and Systems, ALGORITMI Center, University of Minho, Portugal.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pina-Vaz', 'Affiliation': 'DMD, PhD, Faculty of Dental Medicine of University of Porto, Porto, Portugal.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56981']
2260,32913574,Fracture strength of endodontically treated lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite.,"Background


This study aimed to compare the fracture strength, fracture pattern and type of fracture of endodontically treated maxillary lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite.
Material and Methods


Eighty mature permanent maxillary lateral incisors from patients age range of 30-60 years with single canal were selected and randomly divided into: Group 1 - RCT + nanofilled composite (Filtek), Group 2 - RCT + microhybrid composite (Zmack), Group 3 - RCT + new nanohybrid composite (Zr-Hybrid) and Group 4 - Intact teeth (control). Standardized mesio-palatal-distal cavity was prepared, and endodontic treatment was carried out using crown-down technique until size 30, tapered 0.04. Obturation was completed using single cone technique with gutta-percha and AH plus sealer. Cavity access was restored with respective composite resins. Next, teeth were stored in incubator for 24 hours and subdivided into aged and unaged subgroups. Teeth in aged subgroups were subjected to 2500 thermal cycles for 5ºC, 37ºC and 55ºC with 30 seconds dwell time and 5 seconds transfer time. After that, root surfaces of teeth were covered with silicone-based material and placed in boxes filled with acrylic until the cemento-enamel-junction (CEJ) level. They were then tested under Universal Testing Machine until fracture occurred. Samples were then viewed under Leica microscope to determine the fracture pattern and type of fracture. Data analyzed using One-way ANOVA complimented by post hoc Tukey HSD and paired sample T test for fracture strength. Fracture pattern and type of fracture were analyzed using Chi-square test. Level of significance was set at  p <0.05.
Results


Significant differences were observed ( p <0.05) with Group 3 demonstrating the highest fracture strength followed by Group 4, Group 1 and lastly Group 2 in both aged and unaged subgroups respectively. A significant decreased in fracture strength was noted in Group 1 and Group 2 ( p <0.05) as number of thermocycle increased but no significant differences were noted in Group 3 and Group 4 ( p >0.05). Besides, Group 3 and Group 4 showed higher rate of favorable fracture pattern, followed by Group 1 and lastly Group 2. Most favorable fracture pattern was noted to exhibit horizontal fracture type (86.36%), whereas most unfavorable fracture pattern exhibited vertical fracture type (77.78%).
Conclusions


Endodontically treated teeth restored with new zirconia reinforced rice husk nanohybrid composite (Zr-Hybrid) demonstrated higher fracture strength than commercialized composite resins especially after artificial ageing. Zr-Hybrid showed similar fracture pattern to those of intact teeth with higher rate of horizontal fracture type.  Key words: Fracture strength, fracture pattern, composite resin, rice husk, Zirconia.",2020,"Results


Significant differences were observed ( p <0.05) with Group 3 demonstrating the highest fracture strength followed by Group 4, Group 1 and lastly Group 2 in both aged and unaged subgroups respectively.","['endodontically treated lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite', 'Eighty mature permanent maxillary lateral incisors from patients age range of 30-60 years with single canal', 'Teeth in aged subgroups', 'fracture of endodontically treated maxillary lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite']","['RCT + nanofilled composite (Filtek), Group 2 - RCT + microhybrid composite (Zmack), Group 3 - RCT + new nanohybrid composite (Zr-Hybrid) and Group 4 - Intact teeth (control', 'single cone technique with gutta-percha and AH plus sealer']","['Cavity access', 'Fracture pattern and type of fracture', 'rate of favorable fracture pattern', 'number of thermocycle', 'highest fracture strength', 'Fracture strength', 'fracture strength']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",80.0,0.0265567,"Results


Significant differences were observed ( p <0.05) with Group 3 demonstrating the highest fracture strength followed by Group 4, Group 1 and lastly Group 2 in both aged and unaged subgroups respectively.","[{'ForeName': 'Galvin-Sim-Siang', 'Initials': 'GS', 'LastName': 'Lin', 'Affiliation': 'Conservative Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia, Health campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}, {'ForeName': 'Nik-Rozainah-Nik-Abdul', 'Initials': 'NR', 'LastName': 'Ghani', 'Affiliation': 'Conservative Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia, Health campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}, {'ForeName': 'Noor-Huda', 'Initials': 'NH', 'LastName': 'Ismail', 'Affiliation': 'Prosthodontic Unit, School of Dental Sciences, Universiti Sains Malaysia, Health Campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Singbal', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Mahsa University, Bandar Saujana Putra, 42610, Selangor, Malaysia.'}, {'ForeName': 'Devarasa-Giriyapura', 'Initials': 'DG', 'LastName': 'Murugeshappa', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Mahsa University, Bandar Saujana Putra, 42610, Selangor, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Mamat', 'Affiliation': 'Paediatric Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia, Health campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56864']
2261,32913790,Is it possible to improve early childhood development with a video-feedback intervention directed at the mother-father-child triad?,"Relationships with primary caregivers provide the context for early childhood development, and evaluating those relationships during the early years can detect difficulties that may influence future mental health. Video feedback is a valuable intervention tool in early childhood, both for family relationships and child development. An intervention was implemented using this technique, focused on mother-father-child triads that were experiencing difficulties in social-emotional development. Participants were 80 mother-fatherinfant triads (experimental group, EG=40, control group, CG=40), with children between 1 and 3 years old. Socio-emotional difficulties decreased significantly in the children who received the intervention (Wilks λ=0.930, F (1, 78)=5.907; P=.017). There was also an increase in psychomotor development in communication (Wilks λ=0.948, F (1, 78) =4.284; P=.042) and fine motor skills (Wilks λ=0.875, F (1, 78)=11.185; P=.001) in children in the EG compared with children in the CG.",2019,"Socio-emotional difficulties decreased significantly in the children who received the intervention (Wilks λ=0.930, F (1, 78)=5.907; P=.017).","['Participants were 80 mother-fatherinfant triads (experimental group, EG=40, control group, CG=40), with children between 1 and 3 years old']",['Video feedback'],"['psychomotor development in communication', 'Socio-emotional difficulties', 'fine motor skills']","[{'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0076994', 'cui_str': 'Triad resin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",80.0,0.0163579,"Socio-emotional difficulties decreased significantly in the children who received the intervention (Wilks λ=0.930, F (1, 78)=5.907; P=.017).","[{'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Olhaberry', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'León', 'Affiliation': 'Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Sieverson', 'Affiliation': 'Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Escobar', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Iribarren', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Morales-Reyes', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Mena', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Leyton', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.324']
2262,32915892,"Comparison of nebivolol versus diltiazem in improving coronary artery spasm and quality of life in patients with hypertension and vasospastic angina: A prospective, randomized, double-blind pilot study.","BACKGROUND


Beta-blockers are often not the preferred treatment for patients with vasospastic angina. However, nebivolol, beta-blocker with nitric oxide-releasing effect, could theoretically improve coronary vasospasm. We compared nebivolol versus diltiazem in improving coronary vasospasm and quality of life in patients with hypertensive vasospastic angina during a 12-week follow-up.
METHODS


Fifty-one hypertensive patients with documented coronary vasospasm were randomly allocated into 3 treatment groups: (1) Nebivolol Group (5mg for 2 weeks/10mg for 10 weeks); (2) Diltiazem Group (90mg for 2 weeks/180mg for 10 weeks); (3) Low-dose Combination Group (2.5mg + 45mg for 2 weeks/5mg + 90mg for 10 weeks). The primary endpoint was to compare the percent changes in coronary vasospasm at 12 weeks from baseline among the 3 groups. The secondary endpoints included changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure at 12 weeks from baseline.
RESULTS


Significant improvements in coronary vasospasm were found in all groups; however, the improvement in percent changes in coronary artery spasm was greatest in the Diltiazem Group (50.4±8.8% vs. 67.8±12.8% vs. 46.8±12.3%, Nebivolol Group vs. Diltiazem Group p = 0.008; Nebivolol Group vs. Low-dose Combination Group p = 0.999; Diltiazem Group vs. Low-dose Combination Group p = 0.017). The overall Seattle Angina Questionnaire scores were significantly elevated at 12 weeks compared to the baseline in entire study population. There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
CONCLUSIONS


Both nebivolol and diltiazem showed significant coronary vasospasm reduction effect, but the effect was greater for diltiazem.",2020,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","['Fifty-one hypertensive patients with documented coronary vasospasm', 'patients with hypertensive vasospastic angina during a 12-week follow-up', 'patients with hypertension and vasospastic angina', 'patients with vasospastic angina']","['diltiazem', 'Diltiazem', 'nebivolol', 'Nebivolol', 'nebivolol and diltiazem']","['changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure', 'overall Seattle Angina Questionnaire score changes and blood pressure changes', 'coronary vasospasm', 'coronary artery spasm and quality of life', 'coronary vasospasm and quality of life', 'coronary vasospasm reduction effect', 'overall Seattle Angina Questionnaire scores', 'coronary artery spasm']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0002963', 'cui_str': 'Prinzmetal angina'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0068475', 'cui_str': 'nebivolol'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",51.0,0.050534,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","[{'ForeName': 'Hyungdon', 'Initials': 'H', 'LastName': 'Kook', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Sook', 'Initials': 'KS', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sunki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0239039']
2263,32915900,Impact of electrolyte-rich dialysate during continuous renal replacement therapy on serum phosphate and potassium in ICU patients.,"BACKGROUND


Hypophosphatemia and hypokalemia occur frequently during continuous renal replacement therapy (CRRT). We evaluated serum phosphate and potassium levels in patients administered three different types of dialysis solution.
METHODS


The study population consisted of 324 intensive care unit patients who underwent CRRT between January 2015 and December 2018. Patients were divided into three groups: group 1 (n = 105) received Hemosol B0 (no potassium or phosphate); group 2 (n = 78) received Hemosol B0 and potassium-containing solution (MultiBic); and group 3 (n = 141) received phosphate- and potassium-containing solution (Phoxilium), Hemosol B2, Prismasol 2, and Prismasol 4. A different protocol was followed in each group.
RESULTS


The incidence rate of hypophosphatemia was 55% lower in group 3 compared to group 1 (incidence rate ratio (IRR) 0.45, 95% confidence interval (CI): 0.33 to 0.61) and 61% lower compared to group 2 (IRR 0.39, 95% CI: 0.29 to 0.53). Group 3 also had a 50% lower incidence rate of hypokalemia compared to group 1 (IRR 0.50, 95% CI: 0.29 to 0.88). The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008). Additional intravenous calcium was not used in any case, and most cases of acid-base disturbances were well controlled.
CONCLUSIONS


The use of phosphate- and potassium-containing with a proper CRRT protocol prevented decreases in serum phosphate and potassium levels, thus also preventing hypophosphatemia and hypokalemia, and additional replacement during CRRT.",2020,"The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008).","['patients administered three different types of dialysis solution', 'ICU patients', '324 intensive care unit patients who underwent CRRT between January 2015 and December 2018']","['electrolyte-rich dialysate', 'Hemosol B0 and potassium-containing solution (MultiBic', 'Hemosol B0 (no potassium or phosphate', 'continuous renal replacement therapy (CRRT', 'Additional intravenous calcium', 'phosphate- and potassium-containing with a proper CRRT protocol', 'phosphate- and potassium-containing solution (Phoxilium), Hemosol B2, Prismasol 2, and Prismasol 4']","['incidence rate of hypophosphatemia', 'negative slope in the potassium level', 'incidence rate of hypokalemia', 'serum phosphate and potassium levels', 'negative slope in phosphate level', 'hypophosphatemia and hypokalemia', 'serum phosphate and potassium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",,0.0800356,"The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008).","[{'ForeName': 'AJin', 'Initials': 'A', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Ki', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hayne Cho', 'Initials': 'HC', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0238867']
2264,32915904,Automated vessel density detection in fluorescein angiography images correlates with vision in proliferative diabetic retinopathy.,"PURPOSE


To investigate the correlation between quantifiable vessel density, computed in an automated fashion, from ultra-widefield fluorescein angiography (UWFFA) images from patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness.
METHODS


We performed a secondary analysis of a prospective randomized controlled trial. We designed and trained an algorithm to automate retinal vessel detection from input UWFFA images. We then used our algorithm to study the correlation between baseline vessel density and best corrected visual acuity (BCVA) and CRT for patients in the RECOVERY study. Reliability of the algorithm was tested using the intraclass correlation (ICC). 42 patients from the Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study. These patients had PDR without significant center-involving diabetic macular edema (central retinal thickness [CRT] ≤320μm).
RESULTS


Our algorithm analyzed UWFFA images with a reliability measure (ICC) of 0.98. A positive correlation (r = 0.4071, p = 0.0075) was found between vessel density and BCVA. No correlation was found between vessel density and CRT.
CONCLUSIONS


Our algorithm is capable of reliably quantifying vessel density in an automated fashion from baseline UWFFA images. We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
TRANSLATIONAL RELEVANCE


Our work is the first to offer an algorithm capable of quantifying vessel density in an automated fashion from UWFFA images, allowing us to work toward studying the relationship between retinal vascular changes and important clinical endpoints, including visual acuity, in ischemic eye diseases.",2020,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","['proliferative diabetic retinopathy', 'Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study', '42 patients from the', 'patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness']","['ultra-widefield fluorescein angiography (UWFFA) images', 'Intravitreal Aflibercept']","['vessel density and BCVA', 'vessel density and CRT', 'baseline vessel density and best corrected visual acuity (BCVA', 'diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]",42.0,0.0724223,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","[{'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bawany', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Rajeev S', 'Initials': 'RS', 'LastName': 'Ramchandran', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, United States of America.'}, {'ForeName': 'Ajay E', 'Initials': 'AE', 'LastName': 'Kuriyan', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0238958']
2265,32915972,Ibrutinib added to 10-day decitabine for older patients with AML and higher risk MDS.,"The treatment of older, unfit patients with acute myeloid leukemia (AML) is challenging. Based on preclinical data of Bruton tyrosine kinase expression/phosphorylation and ibrutinib cytotoxicity in AML blasts, we conducted a randomized phase 2 multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial). In total, 144 eligible patients were randomly (1:1) assigned to either 10-day decitabine combined with ibrutinib (560 mg; sequentially given, starting the day after the last dose of decitabine) (n = 72) or to 10-day decitabine (n = 72). The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms. In the decitabine plus ibrutinib arm, 41% reached complete remission/complete remission with incomplete hematologic recovery (CR/CRi), the median overall survival (OS) was 11 months, and 2-year OS was 27%; these findings compared with 50% CR/CRi, median OS of 11.5 months, and 2-year OS of 21% for the decitabine group (not significant). Extensive molecular profiling at diagnosis revealed that patients with STAG2, IDH2, and ASXL1 mutations had significantly lower CR/CRi rates, whereas patients with mutations in TP53 had significantly higher CR/CRi rates. Furthermore, multicolor flow cytometry revealed that after 3 cycles of treatment, 28 (49%) of 57 patients with available bone marrow samples had no measurable residual disease. In this limited number of cases, measurable residual disease revealed no apparent impact on event-free survival and OS. In conclusion, the addition of ibrutinib does not improve the therapeutic efficacy of decitabine. This trial was registered at the Netherlands Trial Register (NL5751 [NTR6017]) and has EudraCT number 2015-002855-85.",2020,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","['144 eligible patients', 'older, unfit patients with acute myeloid leukemia (AML', 'unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial', 'older patients with AML and higher risk MDS']","['ibrutinib to 10-day decitabine', '10-day decitabine combined with ibrutinib', 'decitabine', '10-day decitabine', 'Ibrutinib added to 10-day decitabine']","['tolerability and efficacy', 'therapeutic efficacy of decitabine', '2-year OS', 'complete remission/complete remission with incomplete hematologic recovery (CR/CRi', 'number of adverse events', 'median overall survival (OS', 'CR/CRi rates']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",144.0,0.206533,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","[{'ForeName': 'Gerwin', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Chitu', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Saskia K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Department of Hematology, Meander Hospital Amersfoort, Amersfoort, The Netherlands.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stussi', 'Affiliation': 'Department of Hematology, Ospedale Regionale, Bellinzona, Switzerland.'}, {'ForeName': 'Laimonas', 'Initials': 'L', 'LastName': 'Griskevicius', 'Affiliation': 'Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Valk', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjan A', 'Initials': 'AA', 'LastName': 'van de Loosdrecht', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Breems', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg/Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'van Lammeren-Venema', 'Affiliation': 'Department of Hematology, Hagaziekenhuis, Den Haag, The Netherlands.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'van Zeventer', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Hematology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'Department of Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Mels', 'Initials': 'M', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Hematology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Markus G', 'Initials': 'MG', 'LastName': 'Manz', 'Affiliation': 'Department of Medical Oncology and Hematology, Universitätsspital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Söhne', 'Affiliation': 'Department of Hematology, Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Rien', 'Initials': 'R', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Department of Hematology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Dries', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Department of Hematology, AZ Delta Roeselare, Roeselare, Belgium.'}, {'ForeName': 'Marjolein W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Department of Hematology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marie Cecile', 'Initials': 'MC', 'LastName': 'Legdeur', 'Affiliation': 'Department of Hematology, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Lidwine', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'Department of Hematology, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'Division of Hematology, University Hospital Genève and Faculty of Medicine, University of Genève, Genève, Switzerland; and.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Ammatuna', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Blum', 'Affiliation': 'Service and Central Laboratory of Hematology, Department of Oncology and Department of Laboratory Medicine and Pathology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}]",Blood advances,['10.1182/bloodadvances.2020002846']
2266,32921111,"The effect of attention and interpretation therapy on psychological resilience, cancer-related fatigue, and negative emotions of patients after colon cancer surgery.","BACKGROUND


Colon cancer is the most common malignant tumor of the gastrointestinal tract. This cancer and the related treatments bring a raft of lasting physiological and psychological impacts to patients. This study explored the effects of attention and interpretation therapy (AIT) on improving psychological resilience, cancer-related fatigue (CRF), and negative emotions in patients after colon cancer surgery.
METHODS


Patients who had undergone colon cancer surgery in the Affiliated Hospital of Jiangnan University were selected and randomly allocated into an experimental group and a control group, each with 100 cases. Patients in the control group received routine intervention measures, while the experimental group received an extra 10 weeks of AIT. Before and after 10 weeks of intervention, the effects of intervention were evaluated using the Connor-Davidson Resilience Scale (CD-RISC), Self-Rating Anxiety Scale (SAS), Selfrating Depression Scale (SDS) and the Revised Piper Fatigue Scale (PFS-R).
RESULTS


Before the intervention, there was no statistical difference between the scores of psychological resilience, CRF, and negative emotions between the two groups (P>0.05). We compared the scores before and after the 10 weeks of intervention and found that the scores of psychological resilience of the experimental group were higher than before, and the scores of CRF and negative emotion were lower than before. After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
CONCLUSIONS


AIT can effectively strengthen the psychological resilience of patients after colon cancer surgery to a certain extent, reduce anxiety and depression, reduce the degree of CRF, and thus improve the patients' quality of life postoperatively.",2020,"After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
","['patients after colon cancer surgery', 'Patients who had undergone colon cancer surgery in the Affiliated Hospital of Jiangnan University']","['attention and interpretation therapy (AIT', 'attention and interpretation therapy', 'routine intervention measures, while the experimental group received an extra 10 weeks of AIT']","['scores of psychological resilience, CRF, and negative emotions', 'scores of CRF and negative emotion', 'Connor-Davidson Resilience Scale (CD-RISC), Self-Rating Anxiety Scale (SAS), Selfrating Depression Scale (SDS) and the Revised Piper Fatigue Scale (PFS-R', 'psychological resilience, cancer-related fatigue (CRF), and negative emotions', 'CRF and negative emotions scores', 'psychological resilience, cancer-related fatigue, and negative emotions', 'scores of psychological resilience', 'psychological resilience score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.021339,"After the intervention, the psychological resilience score of the experimental group was higher than that of the control group, the CRF and negative emotions scores were lower than those of the control group, and the differences were statistically significant (P<0.05).
","[{'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': ""Yu'e"", 'Initials': 'Y', 'LastName': 'Diao', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Chuanqing', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Jiangnan University, Wuxi, China. mollylcy@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1370']
2267,32903172,"A single-arm study to evaluate the transfer of drospirenone to breast milk after reaching steady state, following oral administration of 4 mg drospirenone in healthy lactating female volunteers.","OBJECTIVE


The primary objective of this trial was to assess the transfer of drospirenone to breast milk after daily administration of an oral test preparation containing 4 mg of drospirenone at the steady state. The secondary objective of the trial was to assess safety based on clinical and laboratory measurements and reporting of adverse events and/or adverse drug reactions.
PATIENTS AND METHODS


This was an open label, non-comparative single-center study. Drospirenone 4 mg per day was the first postpartum contraceptive for the study participants who were no longer breastfeeding yet were still lactating. It was administered for 7 days to achieve steady-state concentration. All participants were volunteers who planned to use oral contraceptives as their family planning method in the future.
RESULTS


Twelve volunteers completed the trial according to the protocol, and the samples of all 12 study completers were analyzed. The average concentration-time curve of drospirenone in plasma 24 h after the administration of the last dose (area under the curve (0-24 h)) was 635.33 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 1180.57 ng h/mL, respectively. The average C max  was 48.64 ng/mL.The average concentration-time curve of drospirenone in milk 24 h after the administration of the last dose (area under the curve (0-24 h)) was 134.35 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 227.17 ng h/mL, respectively. The average C max  was 10.34 ng/mL.
CONCLUSION


On average, 18.13% of plasma drospirenone made it to breast milk and the highest concentration of drospirenone in breast milk was 17.55% of that in plasma. The total quantity of drospirenone passing to breast milk is on average 4478 ng during a 24-h period representing 0.11% of the maternal daily dose. Thus, at the recommended doses, no effects on breastfed newborns/infants are anticipated with drospirenone 4 mg.",2020,"The average concentration-time curve of drospirenone in plasma 24 h after the administration of the last dose (area under the curve (0-24 h)) was 635.33 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 1180.57 ng h/mL, respectively.","['Twelve volunteers completed the trial according to the protocol, and the samples of all 12 study completers were analyzed', 'healthy lactating female volunteers', 'All participants were volunteers who planned to use oral contraceptives as their family planning method in the future']","['plasma drospirenone', 'Drospirenone', 'drospirenone']","['average concentration-time curve', 'total quantity of drospirenone passing to breast milk']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",12.0,0.102754,"The average concentration-time curve of drospirenone in plasma 24 h after the administration of the last dose (area under the curve (0-24 h)) was 635.33 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 1180.57 ng h/mL, respectively.","[{'ForeName': 'Dace', 'Initials': 'D', 'LastName': 'Melka', 'Affiliation': 'Riga Maternity Hospital, Riga, Latvia.'}, {'ForeName': 'Kalev', 'Initials': 'K', 'LastName': 'Kask', 'Affiliation': 'EGeen International Corporation, Mountain View, CA, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Ismaning, Germany.'}]","Women's health (London, England)",['10.1177/1745506520957192']
2268,32918419,Improving cardiopulmonary resuscitation (CPR) performance using an audio-visual feedback device for healthcare providers in an emergency department setting in Malaysia: a quasi-experimental study.,"INTRODUCTION


Cardiopulmonary Resuscitation (CPR) remains the primary mechanism of resuscitation for cardiac arrest victims. However, the quality of delivery of CPR varies widely in different settings, possibly affecting patient outcomes. This study is aimed to determine the efficacy of an audio-visual (AV) CPR feedback device in improving the quality of CPR delivered by healthcare providers.
METHODS


This pre-post, single-arm, quasi-experimental study randomly sampled 140 healthcare providers working in the Emergency Department of Hospital Ampang, Malaysia. Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device. The efficacy of the AV CPR feedback device was assessed using the Chi-square test and Generalised Estimating Equations (GEE) models.
RESULTS


The use of an AV CPR feedback device increased the proportion of healthcare providers achieving recommended depth of chest compressions from 38.6% (95% Confidence Interval, 95%CI: 30.5, 47.2) to 85.0% (95%CI: 78.0, 90.5). A similar significant improvement from 39.3% (95%CI: 31.1, 47.9) to 86.4% (95%CI: 79.6, 91.6) in the recommended rate of chest compressions was also observed. Use of the AV CPR device significantly increased the likelihood of a CPR provider achieving recommended depth of chest compressions (Odds Ratio, OR=13.01; 95%CI: 7.12, 24.01) and rate of chest compressions (OR=13.00; 95%CI: 7.21, 23.44).
CONCLUSION


The use of an AV CPR feedback device significantly improved the delivered rate and depth of chest compressions closer to American Heart Association (AHA) recommendations. Usage of such devices within real-life settings may help in improving the quality of CPR for patients receiving CPR.",2020,"Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device.","['patients receiving CPR', '140 healthcare providers working in the Emergency Department of Hospital Ampang, Malaysia', 'healthcare providers in an emergency department setting in Malaysia']","['AV CPR feedback device', 'cardiopulmonary resuscitation (CPR) performance using an audio-visual feedback device', 'AV CPR device', 'Cardiopulmonary Resuscitation (CPR', 'audio-visual (AV) CPR feedback device']","['rate of chest compressions', 'AV CPR feedback device', 'CPR quality, namely chest compression rate and depth', 'quality of CPR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0183001', 'cui_str': 'Cardiopulmonary resuscitator'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",140.0,0.03837,"Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chelladurai', 'Affiliation': 'Hospital Ampang, Selangor, Malaysia.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Noor Azhar', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mohd Isa', 'Affiliation': 'Hospital Ampang, Selangor, Malaysia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bustam', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Munisamy', 'Affiliation': 'Chulalongkorn University, College of Public Health Sciences, Bangkok, Thailand. murallimd@gmail.com.'}]",The Medical journal of Malaysia,[]
2269,32918434,Resistant hypertension during antituberculosis treatment: how is rifampicin implicated?,"A 67-year-old mental institute resident was treated for smear-positive pulmonary tuberculosis. His background history included chronic essential hypertension which was well-controlled with amlodipine 10mg daily. However, his blood pressure became suboptimal one week into antitubercular treatment, necessitating escalation of antihypertensive therapy up to six medications. Following completion of antitubercular treatment, his blood pressure improved markedly. The number of antihypertensives was able to be reduced to only two after a month. We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.",2020,We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.,['His background history included chronic essential hypertension'],"['amlodipine', 'rifampicin']","['number of antihypertensives', 'blood pressure']","[{'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0273169,We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.,"[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Lee', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Lim', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Chai', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia. chaishuteng@gmail.com.'}]",The Medical journal of Malaysia,[]
2270,32916792,Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial.,"Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants' satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.",2020,"For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05).","['30 people with', 'people with diabetic neuropathy (DPN', 'people at risk of diabetic foot disease', 'People with Diabetic Neuropathy', '45 eligible participants (0.90/week']","['foot-ankle exercise program', 'DPN to usual care (control) or usual care plus a supervised exercise program (intervention', 'Foot-ankle strengthening and mobility exercises', 'Foot-Ankle Exercise Program']","['daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests', 'Program adherence', 'heel peak pressures and force', 'recruitment rate and participant adherence and satisfaction', 'clinical, functional and biomechanical outcomes', 'toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}]",45.0,0.0840922,"For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05).","[{'ForeName': 'Renan L', 'Initials': 'RL', 'LastName': 'Monteiro', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Jane S S P', 'Initials': 'JSSP', 'LastName': 'Ferreira', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Érica Q', 'Initials': 'ÉQ', 'LastName': 'Silva', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Donini', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Ronaldo H', 'Initials': 'RH', 'LastName': 'Cruvinel-Júnior', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Jady L', 'Initials': 'JL', 'LastName': 'Verissímo', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Sicco A', 'Initials': 'SA', 'LastName': 'Bus', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}]","Sensors (Basel, Switzerland)",['10.3390/s20185129']
2271,32916855,The Potential Influence of Group Membership on Outcomes in Indicated Cognitive-Behavioral Adolescent Depression Prevention.,"BACKGROUND


Adolescent depression prevention programs are typically delivered in groups in which adolescents share a common setting and interventionist, but the influence of the group is usually ignored or statistically controlled. We tested whether the primary outcomes of reductions in depressive symptoms and future onset of major depressive disorder (MDD) varied as a function of group membership.
METHODS


Data were available from two randomized trials in which 220 adolescents received the Blues Program indicated prevention intervention in 36 separate groups; participants were assessed at baseline, post intervention, and at 6-, 12-, and 24-month follow-ups.
RESULTS


Ten percent of participants had developed MDD 2 years post intervention. Group-level effects for MDD onset over follow-up were nonsignificant (accounted for <1% of variance; ICC = 0.004, ns). Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05). Group-level clustering of posttest depressive symptoms was not associated with size of group or gender composition.
CONCLUSIONS


Membership in specific adolescent cognitive-behavioral depression prevention groups may have an impact in terms of immediate symptom reduction but does not appear to have significant prevention effects in terms of long-term symptom change or MDD onset.",2020,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).",['Data were available from two randomized trials in which 220 adolescents received the'],"['Blues Program indicated prevention intervention', 'Group Membership']","['depressive symptoms and future onset of major depressive disorder (MDD', 'depressive symptom change']","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",220.0,0.127502,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rohde', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA.'}, {'ForeName': 'Frédéric N', 'Initials': 'FN', 'LastName': 'Brière', 'Affiliation': 'École de Psychoéducation, Université de Montréal, Montreal, QC H3T 1J4, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences), Stanford University Medical Center, Stanford, CA 94305, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186553']
2272,32916983,Telemonitoring in Chronic Pain Management Using Smartphone Apps: A Randomized Controlled Trial Comparing Usual Assessment against App-Based Monitoring with and without Clinical Alarms.,"BACKGROUND


The usefulness of mHealth in helping to target face-to-face interventions for chronic pain more effectively remains unclear. In the present study, we aim to test whether the Pain Monitor mobile phone application (app) is well accepted by clinicians, and can help improve existent medical treatments for patients with chronic musculoskeletal pain. Regarding this last goal, we compared three treatment conditions, namely usual treatment, usual treatment with an app without alarms and usual treatment with an app with alarms. All treatments lasted one month. The three treatments were compared for all outcomes, i.e., pain severity and interference, fatigue, depressed mood, anxiety and anger.
METHODS


In this randomized controlled trial, the usual monitoring method (i.e., onsite;  n  = 44) was compared with daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms ( n  = 45). Alarms were sent to the clinicians in the presence of pre-established undesired clinical events and could be used to make treatment adjustments throughout the one-month study.
RESULTS


With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups). The clinicians were willing to use the app, especially the version with alarms.
CONCLUSIONS


The use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.",2020,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).",['patients with chronic musculoskeletal pain'],"['daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms', 'Pain Monitor mobile phone application (app', 'Telemonitoring', 'usual treatment with an app without alarms and usual treatment with an app with alarms']","['pain severity and interference, fatigue, depressed mood, anxiety and anger']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",,0.0691226,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Department of Personality, Assessment, and Psychological Treatments, Universidad de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zaragozá', 'Affiliation': 'Ciber Fisiopatologia Obesidad y Nutricion (CB06/03 Instituto Salud Carlos III) (Ciber Physiopathology Obesity and Nutrition, CB06/03 Instituto Salud Carlos III Health Institute), 28029 Madrid, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Mesas', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Server', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Medel', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186568']
2273,32917148,"Correction to: Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['older patients under general anesthesia'],"['placebo', 'lidocaine/prilocaine cream']",['cardiovascular reactions from endotracheal intubation and cough events'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0453201,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Operation Room, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Shanghai Shyndec Pharmaceutical Co., Ltd, Shanghai, 600420, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. naturestyle@163.com.'}, {'ForeName': 'Miaoxia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. 1109986151@qq.com.'}]",BMC geriatrics,['10.1186/s12877-020-01651-3']
2274,32917160,Cluster-randomised trial to test the effect of a behaviour change intervention on toilet use in rural India: results and methodological considerations.,"BACKGROUND


Effective and scalable behaviour change interventions to increase use of existing toilets in low income settings are under debate. We tested the effect of a novel intervention, the '5 Star Toilet' campaign, on toilet use among households owning a toilet in a rural setting in the Indian state of Gujarat.
METHODS


The intervention included innovative and digitally enabled campaign components delivered over 2 days, promoting the upgrading of existing toilets to achieve use by all household members. The intervention was tested in a cluster randomised trial in 94 villages (47 intervention and 47 control). The primary outcome was the proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use. We applied a separate questionnaire tool that masked open defecation questions as a physical activity study, and excluded households surveyed at baseline from the post-intervention survey. We calculated prevalence differences using linear regression with generalised estimating equations.
RESULTS


The primary study outcome was assessed in 2483 households (1275 intervention and 1208 control). Exposure to the intervention was low. Post-intervention, toilet use was 83.8% in the control and 90.0% in the intervention arm (unadjusted difference + 6.3%, 95%CI 1.1, 11.4, adjusted difference + 5.0%, 95%CI -0.1, 10.1. The physical activity questionnaire was done in 4736 individuals (2483 intervention and 2253 control), and found no evidence for an effect (toilet use 80.7% vs 82.2%, difference + 1.7%, 95%CI -3.2, 6.7). In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%). Process evaluation suggested that insufficient campaign intensity may have contributed to the low impact of the intervention.
CONCLUSION


The study highlights the challenge in achieving high intervention intensity in settings where the proportion of the total population that are potential beneficiaries is small. Responder bias may be minimised by masking open defecation questions as a physical activity study. Over-reporting of toilet use may be further reduced by avoiding repeated surveys in the same households.
TRIAL REGISTRATION


The trial was registered on the RIDIE registry ( RIDIE-STUDY-ID-5b8568ac80c30 , 27-8-2018) and retrospectively on clinicaltrials.gov ( NCT04526171 , 30-8-2020).",2020,"In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%).","['rural India', '94 villages (47 intervention and 47 control', 'households owning a toilet in a rural setting in the Indian state of Gujarat', '2483 households (1275 intervention and 1208 control', '4736 individuals (2483 intervention and 2253 control']",['behaviour change intervention'],"['toilet use measured with the main questionnaire', 'proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use', 'physical activity questionnaire']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0562819', 'cui_str': 'Does use toilet'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",2483.0,0.105398,"In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%).","[{'ForeName': 'Wolf-Peter', 'Initials': 'WP', 'LastName': 'Schmidt', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Wolf-Peter.Schmidt@lshtm.ac.uk.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Chauhan', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhavsar', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Sandul', 'Initials': 'S', 'LastName': 'Yasobant', 'Affiliation': 'Center for Development Research (ZEF), Bonn, Germany.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Patwardhan', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Aunger', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Dileep', 'Initials': 'D', 'LastName': 'Mavalankar', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Saxena', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Curtis', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",BMC public health,['10.1186/s12889-020-09501-y']
2275,32917187,Improving the informatics competency of critical care nurses: results of an interventional study in the southeast of Iran.,"BACKGROUND


Nursing informatics (NI) along with growth and development of health information technology (HIT) is becoming a fundamental part of all domains of nursing practice especially in critical care settings. Nurses are expected to equip with NI competency for providing patient-centered evidence-based care. Therefore, it is important and necessary to improve nurses' NI competency through educational programs for effective using of HIT. This study aimed to evaluate the impact of a training program on NI competency of critical care nurses.
METHODS


This interventional study was conducted in 2019. Stratified sampling technique was used to select 60 nurses working in critical care units of three hospitals affiliated with a large University of Medical Sciences in the southeast of Iran. These nurses were assigned randomly and equally to the control and intervention groups. NI competency was trained to the intervention group in a three-day workshop. Data were collected using demographic questionnaire and the adapted Nursing Informatics Competency Assessment Tool (NICAT) before and 1 month after the intervention. Rahman in the US (2015) developed and validated the original NICAT to assess self-reported NI competency of nurses with 30 items and three dimensions (Computer literacy, Informatics literacy Information management skills). The NICAT is scored on a five-point Likert scale and the overall score ranges from 30 to150. Two medical informatics specialists and eight nursing faculty members approved the validity of the adapted version of NICAT and its reliability was confirmed by Cronbach's alpha (95%).
RESULTS


All 60 participants completed the educational program and returned the completed questionnaire. Majority of participants in the intervention and control groups were female (83.30%), married nurses (70.90, 73.30%) aged 30-40 years (51.6, 35.5%). In the pretest stage, both intervention and control groups were competent in terms of the NI competency and its dimensions, and no significant difference was observed between them (p = 0.65). However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001). This difference showed that the intervention group was proficient in the posttest stage. The highest mean difference in the intervention group was associated with the informatics literacy dimension and the lowest mean difference was associated with the informatics management skills dimension.
CONCLUSIONS


The improved scores of NI competency and its dimensions after using the training program implied the effectiveness of this method in enhancing the NI competency of nurses working in the critical care units. The application of the training program in diverse domains of nursing practice shows its high efficiency. The project is fundamental for improving nurses' NI competency through continuous educational programs in Iran, other cultures and contexts.",2020,"However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001).","['All 60 participants completed the educational program and returned the completed questionnaire', 'Majority of participants in the intervention and control groups were female (83.30%), married nurses (70.90, 73.30%) aged 30-40\u2009years (51.6, 35.5', '60 nurses working in critical care units of three hospitals affiliated with a large University of Medical Sciences in the southeast of Iran', 'critical care nurses', 'southeast of Iran']",['training program'],['informatics literacy dimension'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0599807', 'cui_str': 'Informatics'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0237001,"However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001).","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Jouparinejad', 'Affiliation': 'Student Research Committee, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, PO Box: 7716913555, Kerman, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Khajouei', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, PO Box: 7716913555, Kerman, Iran. j.farokhzadian@kmu.ac.ir.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01244-5']
2276,32917189,Step-by-step teaching method: improving learning outcomes of undergraduate dental students in layering techniques for direct composite resin restorations.,"BACKGROUND


Layering techniques for direct composite resin restorations might be complicated for inexperienced learners, as a number of materials and instruments are required at each step. The present study aimed to compare and assess the teaching effect of step-by-step and all-in-one teaching methods in layering techniques for direct composite resin restorations among undergraduate dental students.
METHODS


A total of 68 junior dental students participated in this study, which was a prospective and single-blind trial. The students were randomly divided into a step-by-step group (experimental group, n = 34) and all-in-one group (control group, n = 34). The same teacher taught the two groups, ensuring a comparable teaching effect. The final score of each student was an average of scores by two experts who were blinded to the grouping. The scoring system was consisted by five parts. Each part was assigned scores of 3.0, 1.5, or 0. The total maximum score was 15 and minimum was 0. The total time taken by each group was also calculated.
RESULTS


The values of the quality of tooth restorations evaluated by experts for step-by-step and all-in-one groups were 11.29 ± 2.13 from 15 and 9.00 ± 2.71 from 15 (t = 3.88, P < 0.001), respectively. In addition, the time spent by the experimental group was significantly lesser than that spent by the control group, which was 122.47 ± 2.82 and 137.18 ± 6.75 min, respectively (t = 11.72, p < 0.001).
CONCLUSION


With regard to the layering techniques for direct composite resin restorations, the outcomes were better in the step-by-step group than in the all-in-one group.",2020,"In addition, the time spent by the experimental group was significantly lesser than that spent by the control group, which was 122.47 ± 2.82 and 137.18 ± 6.75 min, respectively (t = 11.72, p < 0.001).
","['undergraduate dental students', 'undergraduate dental students in layering techniques for direct composite resin restorations', '68 junior dental students', 'direct composite resin restorations']",[],"['total maximum score', 'learning outcomes', 'values of the quality of tooth restorations', 'total time taken', 'time spent']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",68.0,0.0209915,"In addition, the time spent by the experimental group was significantly lesser than that spent by the control group, which was 122.47 ± 2.82 and 137.18 ± 6.75 min, respectively (t = 11.72, p < 0.001).
","[{'ForeName': 'Jia-Xue', 'Initials': 'JX', 'LastName': 'Yuan', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Ke-Yu', 'Initials': 'KY', 'LastName': 'Yang', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Wang', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Qing-Yu', 'Initials': 'QY', 'LastName': 'Guo', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China. liufei6630@mail.xjtu.edu.cn.""}]",BMC medical education,['10.1186/s12909-020-02230-1']
2277,32917221,"The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition - study protocol for a randomized, double-blind, and placebo-controlled trial.","BACKGROUND


Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on prevention of weight loss of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of nutritional status, enteral nutrition tolerance, and patients' quality of life.
METHODS


Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment.
DISCUSSION


The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients' quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03940768 .",2020,Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects.,"['cancer patients receiving home enteral nutrition', 'cancer patients receiving home enteral nutrition - study protocol', 'Forty patients with cancer receiving home enteral nutrition']","['Lactobacillus plantarum 299v ingestion', 'Lactobacillus plantarum', 'enteral nutrition', 'Lactobacillus plantarum 299v', 'placebo', 'Lactobacillus plantarum 299v (DSM 9843', 'Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo']","['weight loss', 'Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life', 'adverse events', 'nutritional status, enteral nutrition tolerance, and quality of life', 'nausea, vomiting, abdominal pain, and diarrhoea']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",40.0,0.0968996,Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects.,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Kaźmierczak-Siedlecka', 'Affiliation': 'Department of Surgical Oncology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214, Gdansk, Poland. leokadia@gumed.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Folwarski', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Medical University of Gdansk, Dębinki 7, 80-211, Gdansk, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skonieczna-Żydecka', 'Affiliation': 'Department of Human Nutrition and Metabolomics, Pomeranian Medical University in Szczecin, Broniewskiego 24, 71-460, Szczecin, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Ruszkowski', 'Affiliation': 'Department of Physiopathology, Medical University of Gdansk, Dębinki 7, 80-211, Gdansk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Makarewicz', 'Affiliation': 'Department of Surgical Oncology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214, Gdansk, Poland.'}]",Nutrition journal,['10.1186/s12937-020-00598-w']
2278,32919015,The effect of 12-week resistance exercise training on serum levels of cellular aging process parameters in elderly men.,"BACKGROUND


Regular physical activity has a positive effect on the prevention of cellular aging. The present study investigated the effect of 12-week resistance training (RT) on serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme in elderly men.
METHODS


For this purpose, 30 elderly men (age 66.23 ± 0.57 years) were randomly divided into two groups: resistance training group (RET, n = 15) and control group (CTR, n = 15). Participants in RET performed RT protocols with intensity of 60% one-repetition maximum (3×/week, 4 sets of the six exercise circuits). Body composition, physical functioning and, blood samples were assessed before (pre-test) and after (post-test) a 12-week intervention.
RESULTS


The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET. Also, we found a significant difference between the RET and CTR in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.037), PGC1-α (P = 0.007), and telomerase enzyme (P = 0.001).
CONCLUSIONS


12-Week RT increased the levels of proteins associated with the biological aging process in elderly men. It seems that the RT may have beneficial effects on cellular senescence and also improved impaired mitochondrial protein and enzymatic functional induced aging.",2020,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","['elderly men', '30 elderly men (age 66.23\u202f±\u202f0.57\u202fyears']","['12-week resistance training (RT', 'resistance exercise training', 'resistance training group (RET, n\u202f=\u202f15) and control group (CTR']","['PGC1-α', 'RET and CTR in serum levels of SIRT1', 'SIRT6', 'telomerase enzyme', 'serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme', 'SIRT3', 'serum levels of SIRT1', 'Body composition, physical functioning and, blood samples']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C2720169', 'cui_str': 'Sirt3'}, {'cui': 'C1452082', 'cui_str': 'PPARGC1A protein, human'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0157346,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golestani', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezae', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran. Electronic address: aagaeini@ut.ac.ir.'}]",Experimental gerontology,['10.1016/j.exger.2020.111090']
2279,32920186,"An invited commentary on: ""A Randomized Controlled Trial on Irrigation of Open Appendectomy Wound with Gentamicin-Saline Solution versus Saline Solution for Prevention of Surgical Site Infection"" (International Journal of Surgery 2020; Epub ahead of Print).",,2020,,[],['Gentamicin-Saline Solution versus Saline Solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.304305,,"[{'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey. Electronic address: howls_Castle@mynet.com.'}, {'ForeName': 'Huriye', 'Initials': 'H', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.009']
2280,32920219,COVID-19 associated kidney impairment in adult: Qualitative and quantitative analyses with non-enhanced CT on admission.,"PURPOSE


To qualitatively and quantitatively assess kidney imapairment in adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT) and possible correlation between renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission.
METHODS


This study was approved by the local institutional ethics committee. A total of 82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled. RPA and perinephric fat stranding (PFS) were evaluated on NECT imaging. According to the presence of PFS, the patients were divided into two groups: Group A, 38 patients with PFS, and Group B, 44 patients without PFS. Clinical data, including age, gender, clinical classification, SCr levels, and RPA on NECT were analysed. The RPA and SCr of the two groups with COVID-19 were analysed to determine possible difference and correlation. Eighty subjects with no kidney diseases were randomly selected as control group to determine the RPA of normal kidney performed on the same CT scanner.
RESULTS


Mean age, male to female ratio, number of severe and critical cases, and SCr of Group A were higher than those of Group B. Both mean RPA of Group A and Group B were lower than that of control. Mean RPA of Group A was even lower than that of Group B. A significant weak negative linear correlation between RPA on NECT and SCr in COVID-19 was indicated.
CONCLUSIONS


Decrease in RPA on NECT was observed in patients with COVID-19 and a weak linear negative correlation with SCr levels was found. The presence of PFS suggested more severe renal impairment in COVID-19. RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.",2020,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"['82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled', '38 patients with PFS, and Group B, 44 patients without PFS', 'adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT', 'Eighty subjects with no kidney diseases']",[],"['Mean RPA', 'renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission', 'severe renal impairment', 'RPA on NECT', 'SCr levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0227617', 'cui_str': 'Structure of fatty capsule of kidney'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",82.0,0.0205873,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Electrocadiogram, Affiliated Hangzhou First People's Hospital, College of Medicine, Zhejiang University, 261 Huansha Road, 310006, Hangzhou, Zhejiang, People's Republic of China; Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Shuangzhi', 'Initials': 'S', 'LastName': 'Lyu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Senxiang', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': ""Department of Radiation Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Liangrong', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: 1191066@zju.edu.cn.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: chenfenghz@zju.edu.cn.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109240']
2281,32920228,"The effect of pain neurophysiology education on healthcare students' knowledge, attitudes and behaviours towards pain: A mixed-methods randomised controlled trial.","OBJECTIVE


1) To investigate the effects of a brief pain neuroscience education (PNE) lecture on multi-disciplinary healthcare students' knowledge, attitudes and behaviours towards people with pain post intervention and at 6-months follow-up, 2) To explore students' perceptions of PNE.
DESIGN


Mixed-methods randomized controlled trial.
SETTING


UK university.
PARTICIPANTS


Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines.
INTERVENTION


70-min PNE lecture (intervention group) or a 70-min control education.
MAIN OUTCOME MEASURES


1) Knowledge: The Revised Pain Neurophysiology Quiz (RPNQ); 2) Attitudes: Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS); 3) Behaviours: A case vignette to assess clinical recommendations; and 4) Thematic analysis of semi-structured interviews (n = 12).
RESULTS


The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860). Greater improvements in attitudes for the intervention group were seen post-intervention [-10.4 (-16.3, -4.6), P < 0.001] and at 6-months [-5.8 (-11.5, -0.2), P < 0.044]. There was no difference in behaviours between groups. Thematic analysis identified increased patient empathy, partial and patchy reconceptualisation of pain and increased confidence in recommending an active management programme following PNE.
CONCLUSION


This study adds to existing knowledge by demonstrating that a 70-min PNE lecture can have a short-term effect on knowledge and positively shift attitudes towards people with pain in the short and medium-term. It also resulted in some students' reconceptualisation of pain, increased empathy, and confidence to recommend activity. The effect of PNE on clinical behaviours was unclear.",2020,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","['UK university', 'healthcare students', 'Knowledge', 'Attitudes', 'Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines']","['pain neurophysiology education', 'pain neuroscience education (PNE) lecture', '70-min PNE lecture (intervention group) or a 70-min control education', 'PNE']","['knowledge', 'patient empathy, partial and patchy reconceptualisation of pain', ""Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS"", 'knowledge, attitudes and behaviours towards pain', 'pain, increased empathy, and confidence to recommend activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210237,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","[{'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Mankelow', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom. Electronic address: j.mankelow@tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102249']
2282,32920241,"Sustaining the reach of a scalable weight loss intervention through financial incentives - a pragmatic, online randomized trial protocol.","BACKGROUND


High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap.
PURPOSE


To describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business.
METHODS


This study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m 2 , and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program.
DISCUSSION


This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. CLINICALTRIALS.
GOV REGISTRATION


NCT04225234.",2020,This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings.,"['400 individuals aged 19 and older who have a body mass index ≥25\u202fkg/m 2 , and have reliable access to the Internet or a smart phone']",['RCT'],['weight loss and program implementation costs'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",400.0,0.110561,This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings.,"[{'ForeName': 'Tzeyu L', 'Initials': 'TL', 'LastName': 'Michaud', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: tzeyu.michaud@unmc.edu.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'McGuire', 'Affiliation': 'incentaHEALTH, LLC, Denver, CO, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Almeida', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Karls', 'Affiliation': 'Fontenelle Clinic, Nebraska Medicine, Omaha, Nebraska, NE, USA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Love', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Keyonna', 'Initials': 'K', 'LastName': 'King', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Reed', 'Affiliation': 'College of Nursing, Kearney Division, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Gwenndolyn', 'Initials': 'G', 'LastName': 'Porter', 'Affiliation': 'Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Dejun', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106142']
2283,32920242,Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).,"BACKGROUND


The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommended frequencies of interval surveillance imaging. While evidence driven clinical guidelines should promote higher quality care, competing guidelines on the same topic may provide discordant recommendations and potential reduction in the quality and/or value of care.
OBJECTIVES


The primary objective is to compare the clinical effectiveness of the two surveillance guidelines to identify patients most likely to benefit from pancreatic resection. Secondary objectives include comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes.
METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance. All participants will be followed prospectively for 5 years.
CONCLUSION


Differing guidelines confuse providers, patients and policymakers. This large, prospective, randomized trial will compare the clinical effectiveness and resource allocation requirements of two guidelines addressing a common clinical entity. CLINICALTRIALS.
GOV IDENTIFIER


NCT04239573.",2020,"METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","['4606 asymptomatic patients with newly identified pancreatic cysts ≥1\u202fcm in diameter', 'All participants will be followed prospectively for 5\u202fyears']",['high intensity (Fukuoka) or low intensity (AGA) surveillance'],"['comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030283', 'cui_str': 'Cyst of pancreas'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0743997', 'cui_str': 'Incidental Findings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",4606.0,0.104339,"METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Weinberg', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States of America. Electronic address: David.weinberg@fccc.edu.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'UT Southwestern, Simmons Cancer Center, Dallas, TX, United States of America.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania-Abramson Cancer Center, Philadelphia, PA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106144']
2284,32921262,Risk of Paradoxical Embolism (RoPE)-Estimated Attributable Fraction Correlates With the Benefit of Patent Foramen Ovale Closure: An Analysis of 3 Trials.,"BACKGROUND AND PURPOSE


In patients with cryptogenic stroke and patent foramen ovale (PFO), the Risk of Paradoxical Embolism (RoPE) Score has been proposed as a method to estimate a patient-specific ""PFO-attributable fraction""-the probability that a documented PFO is causally-related to the stroke, rather than an incidental finding. The objective of this research is to examine the relationship between this RoPE-estimated PFO-attributable fraction and the effect of closure in 3 randomized trials.
METHODS


We pooled data from the CLOSURE-I (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale), RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment), and PC (Clinical Trial Comparing Percutaneous Closure of Patent Foramen Ovale [PFO] Using the Amplatzer PFO Occluder With Medical Treatment in Patients With Cryptogenic Embolism) trials. We examine the treatment effect of closure in high RoPE score (≥7) versus low RoPE score (<7) patients. We also estimated the relative risk reduction associated with PFO closure across each level of the RoPE score using Cox proportional hazard analysis. We estimated a patient-specific attributable fraction using a PC trial-compatible (9-point) RoPE equation (omitting the neuroradiology variable), as well as a 2-trial analysis using the original (10-point) RoPE equation. We examined the Pearson correlation between the estimated attributable fraction and the relative risk reduction across RoPE strata.
RESULTS


In the low RoPE score group (<7, n=912), the rate of recurrent strokes per 100 person-years was 1.37 in the device arm versus 1.68 in the medical arm (hazard ratio,0.82 [0.42-1.59]  P =0.56) compared with 0.30 versus 1.03 (hazard ratio,0.31 [0.11-0.85]  P =0.02) in the high RoPE score group (≥7, n=1221); treatment-by-RoPE score group interaction,  P =0.12. The RoPE score estimated attributable fraction anticipated the relative risk reduction across all levels of the RoPE score, in both the 3-trial ( r =0.95,  P <0.001) and 2-trial ( r =0.92,  P <0.001) analyses.
CONCLUSIONS


The RoPE score estimated attributable fraction is highly correlated to the relative risk reduction of device versus medical therapy. This observation suggests the RoPE score identifies patients with cryptogenic stroke who are likely to have a PFO that is pathogenic rather than incidental.",2020,"In patients with cryptogenic stroke and patent foramen ovale (PFO), the Risk of Paradoxical Embolism (RoPE) Score has been proposed as a method to estimate a patient-specific ""PFO-attributable fraction""-the probability that a documented PFO is causally-related to the stroke, rather than an incidental finding.","['Patients', 'Patients With Cryptogenic Embolism', 'patients with cryptogenic stroke and patent foramen ovale (PFO', 'patients with cryptogenic stroke', 'Foramen Ovale [PFO', 'Patent Foramen Ovale Closure']","['Amplatzer PFO Occluder With Medical Treatment', 'Percutaneous Closure of Patent']",['rate of recurrent strokes'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0016521', 'cui_str': 'Structure of foramen ovale of heart'}, {'cui': 'C0189967', 'cui_str': 'Closure of patent foramen ovale'}]","[{'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0030650', 'cui_str': 'Patents'}]","[{'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}]",,0.138451,"In patients with cryptogenic stroke and patent foramen ovale (PFO), the Risk of Paradoxical Embolism (RoPE) Score has been proposed as a method to estimate a patient-specific ""PFO-attributable fraction""-the probability that a documented PFO is causally-related to the stroke, rather than an incidental finding.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kent', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., R.R.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Comprehensive Stroke Center and Department of Neurology, David Geffen School of Medicine/University of California Los Angeles (J.L.S.).'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ruthazer', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness (PACE) Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., R.R.).'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Furlan', 'Affiliation': 'Department of Neurology, Case Western Reserve University, Cleveland, OH (A.J.F.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reisman', 'Affiliation': 'Division of Cardiology, University of Washington Medical Center, Seattle (M.R.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Carroll', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Colorado Denver, Aurora (J.D.C.).'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Smalling', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Texas Medical School at Houston (R.W.S.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, ON, Canada (P.J.).""}, {'ForeName': 'Heinrich P', 'Initials': 'HP', 'LastName': 'Mattle', 'Affiliation': 'Department of Neurology, Bern University Hospital, Bern, Switzerland. (H.P.M.).'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Meier', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. (B.M.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Thaler', 'Affiliation': 'Department of Neurology, Tufts Medical Center/Tufts University School of Medicine, Boston, MA. (D.M.K., D.E.T.).'}]",Stroke,['10.1161/STROKEAHA.120.029350']
2285,32921364,Intravenous omega-3 fatty acids are associated with better clinical outcome and less inflammation in patients with predicted severe acute pancreatitis: A randomised double blind controlled trial.,"BACKGROUND AND AIMS


Omega-3 fatty acids (FA) can ameliorate the hyper-inflammatory response that occurs in conditions such as severe acute pancreatitis (SAP) and this may improve clinical outcome. We tested the hypothesis that parenteral omega-3 FA from a lipid emulsion that includes fish oil could be beneficial in patients with predicted SAP by reducing C-reactive protein (CRP) concentration (primary outcome), and modulating the inflammatory response and improving clinical outcome (secondary outcomes).
METHODS


In a phase II randomized double-blind single-centre controlled trial, patients with predicted SAP were randomised to receive a daily infusion of fish oil containing lipid emulsion (Lipidem® 20%, BBraun) for 7 days (n = 23) or a daily infusion of a lipid emulsion without fish oil (Lipofundin® MCT 20%, BBraun) (n = 22).
RESULTS


On admission, both groups had comparable pancreatitis predicted severity and APACHE II scores. Administration of fish oil resulted in lower total blood leukocyte number (P = 0.04), CRP (P = 0.013), interleukin-8 (P = 0.05) and intercellular adhesion molecule 1 (P = 0.01) concentrations, multiple organ dysfunction score, sequential organ failure assessment score (P = 0.004), early warning score (P = 0.01), and systemic inflammatory response syndrome (P = 0.03) compared to the control group. The fish oil group had fewer new organ failures (P = 0.07), lower critical care admission rate (P = 0.06), shorter critical care stay (P = 0.03) and shorter total hospital stay (P = 0.04).
CONCLUSIONS


It is concluded that intravenous administration of a fish oil containing lipid emulsion, a source of omega-3 FA, improves clinical outcomes in patients with predicted SAP, benefits that may be linked to reduced inflammation. CLINICALTRIALS.
GOV NUMBER


NCT01745861.
EU CLINICAL TRIALS REGISTER


EudraCT (2010-018660-16).",2020,"Administration of fish oil resulted in lower total blood leukocyte number (P = 0.04), CRP (P = 0.013), interleukin-8 (P = 0.05) and intercellular adhesion molecule 1 (P = 0.01) concentrations, multiple organ dysfunction score, sequential organ failure assessment score (P = 0.004), early warning score (P = 0.01), and systemic inflammatory response syndrome (P = 0.03) compared to the control group.","['patients with predicted SAP', 'patients with predicted severe acute pancreatitis']","['fish oil containing lipid emulsion ', 'Omega-3 fatty acids (FA', 'parenteral omega-3 FA', 'Intravenous omega-3 fatty acids', 'lipid emulsion without fish oil (Lipofundin® MCT 20%, BBraun', 'fish oil', 'fish oil containing lipid emulsion']","['new organ failures', 'lower critical care admission rate', 'multiple organ dysfunction score, sequential organ failure assessment score', 'total blood leukocyte number', 'CRP', 'intercellular adhesion molecule', 'early warning score', 'shorter critical care stay', 'shorter total hospital stay', 'systemic inflammatory response syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0065043', 'cui_str': 'Lipofundin'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1960439', 'cui_str': 'Multiple organ dysfunction score'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}]",,0.683428,"Administration of fish oil resulted in lower total blood leukocyte number (P = 0.04), CRP (P = 0.013), interleukin-8 (P = 0.05) and intercellular adhesion molecule 1 (P = 0.01) concentrations, multiple organ dysfunction score, sequential organ failure assessment score (P = 0.004), early warning score (P = 0.01), and systemic inflammatory response syndrome (P = 0.03) compared to the control group.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Al-Leswas', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK. Electronic address: dhya@doctros.org.uk.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Eltweri', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK.'}, {'ForeName': 'W-Y', 'Initials': 'WY', 'LastName': 'Chung', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arshad', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephenson', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Al-Taan', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pollard', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton SO16 6YD, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Garcea', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK; Department of Cancer Studies, University of Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK; Department of Cancer Studies, University of Leicester, Leicester, LE1 7RH, UK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Dennison', 'Affiliation': 'Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK; Department of Cancer Studies, University of Leicester, Leicester, LE1 7RH, UK.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.04.003']
2286,32921366,Percutaneous Coronary Intervention or Surgery for Unprotected Left Main Disease: EXCEL Trial at 5 Years.,"Although coronary artery bypass graft (CABG) surgery traditionally has been considered the gold standard for left main revascularization, percutaneous coronary intervention has evolved in the past decades so that it now represents a valid alternative to CABG in a large proportion of cases. The landmark Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest contemporary randomized comparison assessing the impact of revascularization strategies for left main disease. This review discusses the background, rationale, design, results, and implications of the EXCEL trial.",2020,The landmark Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest contemporary randomized comparison assessing the impact of revascularization strategies for left main disease.,[],"['Percutaneous Coronary Intervention or Surgery', 'coronary artery bypass graft (CABG) surgery', 'XIENCE versus Coronary Artery Bypass Surgery']",[],[],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",[],,0.0604503,The landmark Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest contemporary randomized comparison assessing the impact of revascularization strategies for left main disease.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Azzalini', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA. Electronic address: https://twitter.com/SportsDoc2009.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA; The Cardiovascular Research Foundation, New York, NY, USA. Electronic address: gregg.stone@mountsinai.org.'}]",Interventional cardiology clinics,['10.1016/j.iccl.2020.05.002']
2287,32921535,Chlorhexidine bathing to prevent healthcare-associated vancomycin-resistant Enterococcus infections: A cluster quasi-experimental controlled study at intensive care units.,"BACKGROUND/PURPOSE


Vancomycin-resistant Enterococcus (VRE), a multidrug-resistant, difficult-to-treat pathogen of healthcare-associated infections (HAIs), is now endemic at many intensive care units (ICUs). Chlorhexidine (CHG) bathing is a simple and highly effective intervention to decrease VRE acquisition, but its effect on VRE-HAIs has not been assessed in prospective studies at ICUs.
METHODS


This is a cluster quasi-experimental controlled study. Under active VRE surveillance and contact isolation of all identified VRE carriers, four ICUs were assigned to provide 2% CHG bathing for all patients on a daily basis (CHG group) during the intervention period, while another four ICUs were assigned to provide standard care without CHG bathing for all patients (standard care group) during the same period.
RESULTS


The CHG group (n = 1501) had a 62% lower crude incidence of VRE-HAIs during the intervention period, compared with the baseline period (1.0 vs. 2.6 per thousand patient-days, P = 0.009), while VRE-HAIs incidence did not change in standard care group (n = 3299) (1.1 vs. 0.5 per thousand patient-days, P = 0.139). In multivariable analyses, CHG bathing was independently associated with a 70% lower risk of VRE-HAIs (adjusted odds ratio [OR] 0.3, 95% confidence interval [CI], 0.2 to 0.7, P = 0.006). In contrast, standard care during the same period had no effect on the risk of VRE-HAIs (adjusted OR 1.8, 95% CI: 0.7 to 4.7, P = 0.259).
CONCLUSION


CHG bathing is a highly effective approach to prevent VRE-HAIs at ICUs, in the context of active VRE surveillance with contact isolation.",2020,"In multivariable analyses, CHG bathing was independently associated with a 70% lower risk of VRE-HAIs (adjusted odds ratio [OR] 0.3, 95% confidence interval [CI], 0.2 to 0.7, P = 0.006).",['healthcare-associated vancomycin-resistant Enterococcus infections'],"['CHG', 'Chlorhexidine', 'Vancomycin-resistant Enterococcus (VRE', 'Chlorhexidine (CHG']","['VRE acquisition', 'VRE-HAIs incidence', 'risk of VRE-HAIs', 'crude incidence of VRE-HAIs']","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0008586', 'cui_str': 'Chromogranin'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0484604,"In multivariable analyses, CHG bathing was independently associated with a 70% lower risk of VRE-HAIs (adjusted odds ratio [OR] 0.3, 95% confidence interval [CI], 0.2 to 0.7, P = 0.006).","[{'ForeName': 'Kuei-Lien', 'Initials': 'KL', 'LastName': 'Tien', 'Affiliation': 'Center for Infection Control, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jann-Tay', 'Initials': 'JT', 'LastName': 'Wang', 'Affiliation': 'Center for Infection Control, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wang-Huei', 'Initials': 'WH', 'LastName': 'Sheng', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Ji', 'Initials': 'HJ', 'LastName': 'Lin', 'Affiliation': 'Center for Infection Control, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Pao-Yu', 'Initials': 'PY', 'LastName': 'Chung', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chin-Yuan', 'Initials': 'CY', 'LastName': 'Tsan', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chi-Tai', 'Initials': 'CT', 'LastName': 'Fang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan. Electronic address: fangct@ntu.edu.tw.'}, {'ForeName': 'Yee-Chun', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Center for Infection Control, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. Electronic address: yeechunchen@gmail.com.'}, {'ForeName': 'Shan-Chwen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2020.08.048']
2288,32921545,Feasibility of early removal of chest tube in the operating room for spontaneous pneumothorax: A prospective randomized controlled study.,"BACKGROUND/OBJECTIVE


Chest drainage tube after surgery causes pain and prolonged length of hospital stay. Especially, young patients tend to experience greater postoperative pain than elderly patients. Therefore, we needed to discuss the indication of chest tube placement. The purpose of this study was to demonstrate the safety and advantages of post-operative management without drainage tube placement, by comparing cases with and without drainage tube placement.
METHODS


Patients who underwent bullectomy for spontaneous pneumothorax were enrolled in this prospective randomized controlled study and randomized into two groups: group with a post-operative chest tube and group without a chest tube. Surgery and post-operative management were performed according to our protocol.
RESULTS


Among the 42 patients, pneumothorax occurred in 1 patient with a chest tube a day after tube removal. Patients without chest tube had significantly lower post-operative pain (P = 0.107∼P < 0.001), despite their reduced use of rescue drugs. The mean length of post-operative hospital stay was 2.5 days in patients with chest tube, which was significantly longer than that of patients without chest tube (1.2 days; P < 0.001).
CONCLUSIONS


Our patient selection and surgical protocols may be feasible and contribute to post-operative pain control.",2020,Patients without chest tube had significantly lower post-operative pain (P = ,"['spontaneous pneumothorax', 'Patients who underwent bullectomy for spontaneous pneumothorax']","['post-operative management without drainage tube placement', 'post-operative chest tube and group without a chest tube', 'early removal of chest tube']","['pneumothorax', 'mean length of post-operative hospital stay', 'postoperative pain', 'post-operative pain']","[{'cui': 'C0149781', 'cui_str': 'Spontaneous pneumothorax'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",42.0,0.0297381,Patients without chest tube had significantly lower post-operative pain (P = ,"[{'ForeName': 'Yo', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'Division of General Thoracic Surgery, Department of Surgery, Shiga University of Medical Science, Shiga, Japan; Division of General Thoracic Surgery, Kusatsu General Hospital, Shiga, Japan. Electronic address: kawaguchi1228@yahoo.co.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hanaoka', 'Affiliation': 'Division of General Thoracic Surgery, Department of Surgery, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Division of General Thoracic Surgery, Department of Surgery, Shiga University of Medical Science, Shiga, Japan; Division of General Thoracic Surgery, Kusatsu General Hospital, Shiga, Japan.'}]",Asian journal of surgery,['10.1016/j.asjsur.2020.08.009']
2289,32921569,"Pain Incidence, Treatment, and Associated Symptoms in Hospitalized Persons with Dementia.","BACKGROUND


Moderate to severe pain has been frequently reported in hospitalized older adults. Pain in hospitalized persons with dementia within the context of other common symptoms, functional decline, delirium, and behavioral and psychological symptoms of dementia (BPSD), has received little attention.
AIMS


Describe the incidence of pain, the pharmacologic management of pain, and the association of pain with physical function, delirium, and BPSD in hospitalized persons with dementia.
DESIGN


Descriptive, cross-sectional study.
SETTING


Six medical units in three hospitals.
PARTICIPANTS


Baseline data from 299 hospitalized persons with dementia enrolled in the Family-centered Function-focused Care (Fam-FFC) cluster randomized trial.
METHODS


Descriptive analyses of pain used the Pain Assessment in Advanced Dementia (PAINAD) scale and the use of medication for pain management. Linear regression analyses tested relationships between pain and:1) physical function (Barthel Index), 2) delirium severity (Confusion Assessment Method Severity Short Form) and 3) BPSD severity (Neuropsychiatric Inventory- Questionnaire).
RESULTS


The majority of the sample was female (61.9%), non-Hispanic (98%), and Black (53.2%), with a mean age of 81.58 (SD=8.54).Of the 299 patients, 166 (56%) received pain medication. Of the 108 individuals who demonstrated pain, 40% (n=43) did not receive pain medication. When controlling for age, gender, cognition, and comorbidities, pain was significantly associated with function, delirium severity, and BPSD severity.
CONCLUSIONS


Results suggest that pain may be undertreated in hospitalized persons with dementia, and should be considered upon admission to optimize function, decrease delirium, and prevent or decrease BPSD.",2020,"Linear regression analyses tested relationships between pain and:1) physical function (Barthel Index), 2) delirium severity (Confusion Assessment Method Severity Short Form) and 3) BPSD severity (Neuropsychiatric Inventory- Questionnaire).
","['Six medical units in three hospitals', 'hospitalized persons with dementia within the context of other common symptoms, functional decline, delirium, and behavioral and psychological symptoms of dementia (BPSD', 'hospitalized older adults', '108 individuals who demonstrated pain, 40% (n=43) did not receive pain medication', '299 hospitalized persons with dementia enrolled in the Family-centered Function-focused Care (Fam-FFC) cluster randomized trial', 'hospitalized persons with dementia', 'Hospitalized Persons with Dementia', 'sample was female (61.9%), non-Hispanic (98%), and Black (53.2%), with a mean age of 81.58 (SD=8.54).Of the 299 patients, 166 (56%) received pain medication']",[],"['pain and:1) physical function (Barthel Index), 2) delirium severity (Confusion Assessment Method Severity Short Form) and 3) BPSD severity (Neuropsychiatric Inventory- Questionnaire', 'Pain Incidence, Treatment, and Associated Symptoms', 'Pain', 'function, delirium severity, and BPSD severity']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0569826,"Linear regression analyses tested relationships between pain and:1) physical function (Barthel Index), 2) delirium severity (Confusion Assessment Method Severity Short Form) and 3) BPSD severity (Neuropsychiatric Inventory- Questionnaire).
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Boltz', 'Affiliation': 'College of Nursing, Pennsylvania State University, University Park, PA. Electronic address: mpb40@psu.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Resnick', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, MD.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Kuzmik', 'Affiliation': 'College of Nursing, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Mogle', 'Affiliation': 'Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Joanne Roman', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'College of Nursing, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Arendacs', 'Affiliation': 'College of Nursing, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'BeLue', 'Affiliation': 'St. Louis University, St. Louis, MO.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Cacchione', 'Affiliation': 'College of Nursing, Pennsylvania State University, University Park, PA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Galvin', 'Affiliation': 'University of Miami, Miami, FL.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2020.08.002']
2290,32921587,Dorsolateral Prefrontal Cortex and Subcallosal Cingulate Connectivity Show Preferential Antidepressant Response in Major Depressive Disorder.,"BACKGROUND


Major depressive disorder is associated with abnormal connectivity across emotion and reward circuits as well as other established circuits that may negatively impact treatment response. The goal of this study was to perform an exploratory reanalysis of archival data from a clinical trial to identify moderators of treatment outcome of sertraline over placebo.
METHODS


EMBARC (Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care) study participants completed magnetic resonance imaging before randomization to either sertraline or placebo for 8 weeks (n = 279). Seed-based functional connectivity was computed using 4 bilateral seeds (2 spheres defined bilaterally): amygdala, dorsolateral prefrontal cortex (DLPFC), subcallosal cingulate cortex, and ventral striatum. Functional connectivity maps were generated, principal component analysis was performed, linear mixed effects models were used to determine moderators of treatment outcome, and post hoc analyses were used to determine level of connectivity (low and high, -1 and +1 SD from the mean) that was most sensitive to improved depression severity (baseline to week 8) based on treatment.
RESULTS


Greater mean reduction in the 17-item Hamilton Rating Scale for Depression score by 8 weeks occurred with sertraline relative to placebo when connectivity in the DLPFC was low (3-way interaction test, p = .05). Conditional on low connectivity in the DLPFC and subcallosal cingulate cortex and high connectivity in the ventral striatum and amygdala, there was on average a 4.8-point greater reduction in the 17-item Hamilton Rating Scale for Depression score with sertraline relative to placebo (p = .003).
CONCLUSIONS


The level of functional connectivity seeded in both the DLPFC and the subcallosal cingulate cortex networks may play an important role in identifying a favorable response to sertraline over placebo.",2020,Greater mean reduction in the 17-item Hamilton Rating Scale for Depression,['Major Depressive Disorder'],"['sertraline or placebo', 'placebo', 'sertraline over placebo']","['17-item Hamilton Rating Scale for Depression score', '17-item Hamilton Rating Scale for Depression', 'depression severity']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.111815,Greater mean reduction in the 17-item Hamilton Rating Scale for Depression,"[{'ForeName': 'Cherise R', 'Initials': 'CR', 'LastName': 'Chin Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Aslan', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas; Advance MRI, LLC, Frisco, Texas.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Grannemann', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Greer', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute, College of Physicians and Surgeons of Columbia University, New York, New York.'}, {'ForeName': 'Ramin V', 'Initials': 'RV', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California; Stanford Neurosciences Institute, Stanford University, Stanford, California; Sierra-Pacific Mental Illness Research, Education and Clinical Center, VA Palo Alto Healthcare System, Palo Alto, California.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: madhukar.trivedi@utsouthwestern.edu.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.06.019']
2291,32921665,"Randomized, Open-Label, Cross-Over Comparison of the Effects of Benzbromarone and Febuxostat on Endothelial Function in Patients with Hyperuricemia.","Uric acid is generated with reactive oxygen species via xanthine oxidase (XO), and hyperuricemia, which is identified as the excess of uric acid in the blood, has been associated with vascular endothelial dysfunction. However, the effects of urate-lowering medicines on endothelial function have not been fully elucidated. Thus this study determined and compared the effects of benzbromarone (urate transporter 1 inhibitor) and febuxostat (XO inhibitor) on endothelial function.This randomized, cross-over, open-label study initially recruited 30 patients with hyperuricemia. They were divided into two groups, treated initially with benzbromarone or febuxostat for three months and then were switched for the next three months. Endothelial function was defined as reactive hyperemia indexes (RHI) determined using Endo-PAT 2000 before and at three and six months after medication using the two agents. Blood levels of asymmetric dimethylarginine (ADMA) and high-molecular-weight (HMW) adiponectin were also compared. We finally analyzed data from 24 patients whose endothelial function was assessed as described above.Our findings show that levels of uric acid significantly decreased, whereas those of HMW adiponectin and the RHI have significantly increased after treatment with benzbromarone. Meanwhile, in patients administered with febuxostat, uric acid levels tended to decrease and RHI significantly decreased. Neither of the two agents altered ADMA levels. The changes in RHI (P = 0.026) and HMW adiponectin levels (P = 0.001) were found to be significantly greater in patients treated with benzbromarone than febuxostat. Changes in the levels of HMW adiponectin and of uric acid were significantly correlated (r = -0.424, P = 0.039).Benzbromarone has increased adiponectin besides reducing uric acid levels, and thus, this might confer more benefits on endothelial function than febuxostat.",2020,"Changes in the levels of HMW adiponectin and of uric acid were significantly correlated (r = -0.424, P = 0.039).Benzbromarone has increased adiponectin besides reducing uric acid levels, and thus, this might confer more benefits on endothelial function than febuxostat.","['30 patients with hyperuricemia', 'Patients with Hyperuricemia']","['benzbromarone or febuxostat', 'benzbromarone (urate transporter 1 inhibitor) and febuxostat (XO inhibitor', 'benzbromarone', 'urate-lowering medicines', 'febuxostat', 'Benzbromarone and Febuxostat']","['Endothelial Function', 'ADMA levels', 'reactive hyperemia indexes (RHI', 'levels of uric acid', 'levels of HMW adiponectin and of uric acid', 'changes in RHI', 'Endothelial function', 'HMW adiponectin levels', 'Blood levels of asymmetric dimethylarginine (ADMA) and high-molecular-weight (HMW) adiponectin', 'endothelial function', 'HMW adiponectin and the RHI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}]","[{'cui': 'C0005035', 'cui_str': 'Benzbromarone'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0534759', 'cui_str': 'urate transporter'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",30.0,0.0196686,"Changes in the levels of HMW adiponectin and of uric acid were significantly correlated (r = -0.424, P = 0.039).Benzbromarone has increased adiponectin besides reducing uric acid levels, and thus, this might confer more benefits on endothelial function than febuxostat.","[{'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Nakata', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Koga', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Yonekura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuneto', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Satoki', 'Initials': 'S', 'LastName': 'Fukae', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Minami', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kawano', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Maemura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences.'}]",International heart journal,['10.1536/ihj.20-114']
2292,32916985,Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Protocol: A Randomized Clinical Trial.,"Fire Department of New York (FDNY) rescue and recovery workers exposed to World Trade Center (WTC) particulates suffered loss of forced expiratory volume in 1 s (FEV 1 ). Metabolic Syndrome increased the risk of developing WTC-lung injury (WTC-LI) .  We aim to attenuate the deleterious effects of WTC exposure through a dietary intervention targeting these clinically relevant disease modifiers. We hypothesize that a calorie-restricted Mediterranean dietary intervention will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. To assess our hypothesis, we developed the Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE), a randomized controlled clinical trial (RCT). Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included. We will randomize subjects (1:1) to either: (1) Low Calorie Mediterranean (LoCalMed)-an integrative multifactorial, technology-supported approach focused on behavioral modification, nutritional education that will include a self-monitored diet with feedback, physical activity recommendations, and social cognitive theory-based group counseling sessions; or (2) Usual Care. Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary). By implementing a technology-supported LoCalMed diet our FIREHOUSE RCT may help further the treatment of WTC associated pulmonary disease.",2020,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).",['Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included'],"['Protocol', 'calorie-restricted Mediterranean dietary intervention', 'Low Calorie Mediterranean ']","['reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary', 'metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0628545,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Riggs', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Crowley', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Isabel R', 'Initials': 'IR', 'LastName': 'Young', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nayar', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sunseri', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Mena', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Ostrofsky', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Arul', 'Initials': 'A', 'LastName': 'Veerappan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Zeig-Owens', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schwartz', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Colbeth', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mengling', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Population Health, Division of Biostatistics, New York University School of Medicine, New York, NY 10016, USA.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Pompeii', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'St-Jules', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Prezant', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nolan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186569']
2293,32917039,The Retentive Strength of Zirconium Oxide Crowns Cemented by Self-Adhesive Resin Cements before and after 6 Months of Aging.,"The aim of this study was to evaluate the retentive strength of zirconium oxide (yttria-stabilized tetragonal zirconia polycrystals (Y-TZP)) crown-copings treated by combined mechanical and chemical treatments and cemented by four types of self-adhesive resin cements (SARCs) to human prepared teeth, before and after six months of aging in water and thermocycling. A total of 120 molar teeth were mounted, prepared using a standardized protocol and digitally scanned, and Y-TZP copings were produced. Teeth were randomly assigned to four SARC groups. Prior to cementation, the intaglio surfaces of all crowns were sandblasted and then coated with Z-Prime™ Plus (Bisco Dental, Schaumburg, IL, USA). Post cementation, each cement group was subdivided into aged and non-aged groups. After aging, the cemented assemblies were tested for retentive strength using a universal testing machine. Failure analysis was conducted by inspecting all matched debonded surfaces of the teeth and crowns at 3× magnification. Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918). The interaction between cement and aging was statistically significant ( p  = 0.024). No significant differences in the retentive strengths between the different SARCs were observed pre-aging ( p  = 0.776), whereas post-aging, Panavia SA (PAN; Kuraray Dental Co Ltd., Osaka, Japan) showed significantly higher strength than RelyX U-200 (RU200; 3M ESPE, Seefeld, Germany). The predominant failure mode was adhesive between the cement and dentin, followed by mixed mode failure.",2020,Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918).,['A total of 120 molar teeth'],['zirconium oxide (yttria-stabilized tetragonal zirconia polycrystals (Y-TZP'],"['Retentive Strength', 'retentive strength', 'retentive strengths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1567733', 'cui_str': 'yttria stabilized tetragonal zirconia'}]",[],120.0,0.024198,Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918).,"[{'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Levartovsky', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Lilac', 'Initials': 'L', 'LastName': 'Cartier', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Jaron John', 'Initials': 'JJ', 'LastName': 'Blasbalg', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Pilo', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}]","Materials (Basel, Switzerland)",['10.3390/ma13183998']
2294,32917223,Development of competency model for family physicians against the background of 'internet plus healthcare' in China: a mixed methods study.,"BACKGROUND


Identification of the service competences of family physicians is central to ensuring high-quality primary care and improving patient outcomes. However, little is known about how to assess the family physicians' service competences in primary care settings. It is necessary to develop and validate a general model of core competences of the family physician under the stage of construction of family doctor system and implementation of 'Internet Plus Healthcare' service model in China.
METHODS


The literature review, behavioural event interviews, expert consultation and questionnaire survey were performed. The scale's 35 questions were measured by response rate, highest score, lowest score, and average score for each. Delphi method was used to assess content validity, Cronbach's α to estimate reliability, and factor analysis to test structural validity. Respondents were randomly divided into two groups; data for one group were used for exploratory factor analysis (EFA) to explore possible model structure. Confirmatory factor analysis (CFA) was then performed.
RESULTS


Effective response rate was 93.56%. Cronbach's α coefficient of the scale was 0.977. Factor analysis showed KMO of 0.988. Bartlett's test showed χ 2  of 22 917.515 (df = 630), p < .001. Overall authority grade of expert consultation was 0.80, and Kendall's coefficient of concordance W was 0.194. By EFA, the five-factor model was retained after thorough consideration, and four items with factor loading less than 0.4 were proposed to obtain a five-dimension, 32-item scale. CFA was performed on the new structure, showing high goodness-of-fit test (NFI = 0.98, TLI = 0.91, SRMSR = 0.05, RMSEA = 0.04). Overall Cronbach's α coefficients of the scale and each sub-item were greater than 0.9.
CONCLUSIONS


The scale has good reliability, validity, and credibility and can therefore serve as an effective tool for assessment of Chinese family physicians' service competences.",2020,"Bartlett's test showed χ 2  of 22 917.515 (df = 630), p < .001.","[""family physicians against the background of 'internet plus healthcare' in China""]",['CFA'],"['Overall authority grade of expert consultation', 'Effective response rate']","[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0234521,"Bartlett's test showed χ 2  of 22 917.515 (df = 630), p < .001.","[{'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': ""Department of Social Medicine and Health Service Management, School of Medicine and Health Management, Hangzhou Normal University, NO. 2318, Yuhangtang Rd, Yuhang District, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Xiaohe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Social Medicine and Health Service Management, School of Medicine and Health Management, Hangzhou Normal University, NO. 2318, Yuhangtang Rd, Yuhang District, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Social Medicine and Health Service Management, School of Medicine and Health Management, Hangzhou Normal University, NO. 2318, Yuhangtang Rd, Yuhang District, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Health Management, School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, No. 13 Hangkong Road, Wuhan, 430030, Hubei, People's Republic of China. lucky1230405@163.com.""}]",Human resources for health,['10.1186/s12960-020-00507-6']
2295,32917251,VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures.,"BACKGROUND


Vessel-sparing anastomotic repair (vsAR) has been developed as a less traumatic alternative to transecting anastomotic repair (tAR) to treat isolated short bulbar urethral strictures. This vessel-sparing technique could result in improved functional outcomes without jeopardizing the excellent surgical outcome after (transecting) anastomotic repair. The purpose of this study is to directly compare vsAR and tAR for both surgical and functional outcomes.
METHODS


This trial is a prospective, interventional, multi-center, single-blinded, 1:1 randomized, controlled, non-inferiority, phase II trial. Sample size calculation resulted in a required sample size of 100 patients (50 patients per arm). Trial participants will be randomized by an independent third party using a computer-based random sequence generator with permuted blocks of variable size. The primary objective of this trial is to show that vsAR is non-inferior to tAR in terms of failure-free survival after 24 months of follow-up, considering a non-inferiority limit of 10%. Failure is defined as the inability to pass a 16-Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa. Secondary end-points mainly include differences in postoperative complications and changes in functional outcome parameters, which will be assessed with validated questionnaires. All participants are scheduled for follow-up at 3, 12, and 24 months postoperatively.
DISCUSSION


This trial will provide level Ib evidence about the differences in both surgical and functional outcome between vsAR and tAR, which may importantly scape the future of bulbar urethral reconstruction. Depending on the trial results, this phase II trial may generate a larger phase III trial with more statistical power and a lower alpha value.
TRIAL REGISTRATION


This trial is registered at clinicaltrials.gov ( NCT03572348 ) and in the Belgian Clinical Trial Registry (B670201837335). The trial was registered prospectively. Registered on 28 June 2018.",2020,Failure is defined as the inability to pass a 16-Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa.,['isolated short bulbar urethral strictures'],"['vessel-sparing anastomotic repair and transecting anastomotic repair', 'Vessel-sparing anastomotic repair (vsAR']",['postoperative complications and changes in functional outcome parameters'],"[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.258692,Failure is defined as the inability to pass a 16-Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa.,"[{'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Verla', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. wesley.verla@uzgent.be.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Waterloos', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Waterschoot', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Parys', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Spinoit', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Nicolaas', 'Initials': 'N', 'LastName': 'Lumen', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04712-5']
2296,32917259,Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the ""Berlin"" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.
TRIAL DESIGN


This is a prospective, randomized (1:1 ratio), parallel group feasibility study in adult patients with proven COVID-19 associated ARDS.
PARTICIPANTS


All adult patients admitted to the ICU of Hamad Medical Corporation facilities in Qatar because of COVID-19 infection who develop moderate to severe ARDS are eligible. The inclusion criteria are above 18 years of age, proven COVID-19 infection, respiratory failure necessitating intubation and mechanical ventilation, ARDS with a P/F ratio of at least 200mmHg or less and a minimum PEEP 5cmH2O, BMI less 30 kg/ m2. The following exclusion criteria: no written consent, chronic respiratory disease, acute or chronic cardiovascular disease, pregnancy or need for special therapy (prone position and/or Extracorporeal membrane oxygenation).
INTERVENTION AND COMPARATOR


After randomisation, the group A patients will be ventilated with the test-device for 48 hours. The settings will be started with the pre-existing-PEEP. The upper pressure will be determined to achieve a tidal volume of 6 ml/kg lean body mass, while the respiratory rate will be set to maintain an arterial pH above 7.2. In group B, the ventilator settings will be adjusted by the attending ICU team in accordance with lung-protective ventilation strategy. All other treatment will be unchanged and according to our local policies/guidelines.
MAIN OUTCOMES


The primary end point is PaO2. As this is a dynamic parameter, we will record it every 6-8 hours and analyse it sequentially.
RANDOMISATION


The study team screens the ventilated patients who fulfil the inclusion criteria and randomise using a 1:1 allocation ratio after consenting using a closed envelope method. The latter were prepared and sealed in advance by an independent person.
BLINDING (MASKING)


Due to the technical nature of the study (use of a specific ventilator) blinding is only possible for the data-analysts and the patients.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The sample size calculation based on the assumption of an effect size (change in PaO2) of 1.5 SDS in the primary endpoint (PaO2), an intended power of 80%, an alpha error of 5% and an equal sample ratio results in n=7 patients needed to treat. However, to compensate for dropouts we will include 10 patients in each group, which means in total 20 patients.
TRIAL STATUS


The local registration number is MRC-05-018 with the protocol version number 3. The date of approval is 14 th  April 2020. Recruitment began 28th May 2020 and is expected to end in September 2020.
TRIAL REGISTRATION


The protocol was registered before starting subject recruitment under the title: ""Flow controlled ventilation in ARDS associated with COVID-19"" in ClinicalTrials.org with the registration number: NCT04399317 . Registered on 22 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the ""Berlin"" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.
","['ventilated patients who fulfil the inclusion criteria and randomise using a 1:1 allocation ratio after consenting using a closed envelope method', '10 patients in each group, which means in total 20 patients', 'conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS', 'The inclusion criteria are above 18 years of age, proven COVID-19 infection, respiratory failure necessitating intubation and mechanical ventilation, ARDS with a P/F ratio of at least 200mmHg or less and a minimum PEEP 5cmH2O, BMI less 30 kg/ m2', 'chronic respiratory disease, acute or chronic cardiovascular disease, pregnancy or need for special therapy (prone position and/or Extracorporeal membrane oxygenation', 'adult patients with proven COVID-19 associated ARDS', 'Acute Respiratory Distress Syndrome associated with COVID-19', 'All adult patients admitted to the ICU of Hamad Medical Corporation facilities in Qatar because of COVID-19 infection who develop moderate to severe ARDS are eligible']","['Flow controlled ventilation', 'flow-controlled ventilation']",['PaO2'],"[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}]","[{'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}]",10.0,0.236715,"This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the ""Berlin"" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roehrig', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ait Hssain', 'Affiliation': 'Department of Medical Intensive Care, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Nabil Al Hamid', 'Initials': 'NAH', 'LastName': 'Shallik', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ingi Mohamed A', 'Initials': 'IMA', 'LastName': 'Elsaid', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Salma Faisal', 'Initials': 'SF', 'LastName': 'Mustafa', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Osama A M', 'Initials': 'OAM', 'LastName': 'Smain', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ashraf Abdulla', 'Initials': 'AA', 'LastName': 'Molokhia', 'Affiliation': 'Department of Medical Intensive Care, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Lance', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar. Mlance@hamad.qa.'}]",Trials,['10.1186/s13063-020-04708-1']
2297,32917271,"High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I-II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China.","INTRODUCTION


The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant and anti-inflammatory properties such as N-acetylcysteine (NAC) can reduce the rate of exacerbations in patients with COPD. However, the beneficial effects of NAC in early-stage COPD are minimally discussed. We are investigating whether high-dose NAC has therapeutic effects in Chinese patients with early-stage COPD.
METHOD AND ANALYSIS


A randomized, double-blinded, placebo-controlled, parallel-group, multicenter clinical trial is evaluating the efficacy and safety of NAC for the long-term treatment of patients with early-stage COPD at 24 centers in China. Subjects aged 40-80 years and recruited by physicians or researchers with special training will be randomized to either NAC 600 mg twice daily group or matching placebo group for 2 years. Measurements will include forced expiratory volume in 1 s (FEV 1 ), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis.
DISCUSSION


Currently, there are no randomized controlled trials with high-dose N-acetylcysteine (600 mg twice daily) for patients with mild-to-moderate COPD (GOLD I-II). We designed this multicenter randomized controlled trial (RCT) to assess the effectiveness, safety, and cost-effectiveness of long-term treatment with high-dose N-acetylcysteine. The results of this trial may guide clinical practice and change the standard of early COPD management.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IIR-17012604 . Registered on 07 September 2017.",2020,"Measurements will include forced expiratory volume in 1 s (FEV 1 ), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis.
","['early-stage chronic obstructive pulmonary disease (GOLD I-II', 'Subjects aged 40-80\u2009years and recruited by physicians or researchers with special training', 'patients with COPD', 'patients with mild-to-moderate COPD (GOLD I-II', 'subjects with chronic obstructive pulmonary disease (COPD', 'Chinese patients with early-stage COPD', 'patients with early-stage COPD at 24 centers in China']","['high-dose N-acetylcysteine', 'High-dose N-acetylcysteine', 'placebo', 'NAC', 'acetylcysteine', 'NAC 600\u2009mg twice daily group or matching placebo']","['efficacy and safety', 'effectiveness, safety, and cost-effectiveness', 'number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis', 'rate of exacerbations']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0206335', 'cui_str': 'Pharmaceutical Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.717168,"Measurements will include forced expiratory volume in 1 s (FEV 1 ), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis.
","[{'ForeName': 'Heshen', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhishan', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bijia', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shaodan', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dongxing', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Pixin', 'Initials': 'P', 'LastName': 'Ran', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China. pxran@gzhmu.edu.cn.'}]",Trials,['10.1186/s13063-020-04701-8']
2298,32917288,"Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL).","BACKGROUND


Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported. The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life.
METHODS


The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20 mg three times per week for 9 months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status 0 to 2; main exclusion criteria are life expectancy less than 4 weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews.
DISCUSSION


To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer.
TRIAL REGISTRATION


EU Clinical Trial Register, EudraCT Number 2014-004552-64 . Registered on 19 January 2016. ClinicalTrials.gov NCT02948309 . Registered on 28 October 2016.",2020,"To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer.","['patients with advanced pancreatic cancer', 'advanced pancreatic cancer', 'pancreatic cancer patients', '290 participants', 'advanced pancreatic cancer patients with regard to overall survival and health-related quality of life', 'advanced pancreatic cancer patients']","['placebo', 'standard treatment (palliative chemotherapy or best supportive care', 'mistletoe extract', 'placebo or mistletoe extract']","['overall survival and health-related quality of life', 'overall survival and better health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C1166209', 'cui_str': 'Viscum album preparation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",290.0,0.535861,"To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer.","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Wode', 'Affiliation': 'Department Nursing, Umeå University, Umeå, Sweden. kathrin.wode@umu.se.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hök Nordberg', 'Affiliation': 'Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden.'}, {'ForeName': 'Gunver S', 'Initials': 'GS', 'LastName': 'Kienle', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Nils O', 'Initials': 'NO', 'LastName': 'Elander', 'Affiliation': 'Department Oncology and Department Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Britt-Marie', 'Initials': 'BM', 'LastName': 'Bernhardson', 'Affiliation': 'Department Learning, Informatics, Management, and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Sunde', 'Affiliation': 'Department Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sharp', 'Affiliation': 'Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Henriksson', 'Affiliation': 'Department Radiation Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Fransson', 'Affiliation': 'Department Nursing, Umeå University, Umeå, Sweden.'}]",Trials,['10.1186/s13063-020-04581-y']
2299,32919092,"Training effects of attention and EF strategy-based training ""Nexxo"" in school-age students.","Given the importance of attention and executive functions in children's behavior, programs directed to improve these processes are of interest. Nexxo-training combines the use of the Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies. The present paper reports a test of Nexxo's impact on children aged 6-7 and 8-9 years. We conducted a randomized active-controlled trial involving 108 typically-developing children: 1st grade (N = 61, M = 6.46 years, SD = 0.35) and 3rd grade (N = 47, M = 8.5 years, SD = 0.27), randomly assigned to: (1) experimental, (2) active-control, or (3) passive-control groups. A 2-month follow-up was carried out after the intervention. The 3rd grade experimental group displayed a significant reduction in attentional problems at follow-up compared to both control groups. Executive Function problems were also reduced at follow-up in the experimental group. Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls. Although group effect was not significant at t1, it was significant at post measures in experimental group compared to passive-controls. Nexxo-training revealed a trend-level improvement in attention and executive functions for children in the 3rd grade.",2020,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"['school-age students', '108 typically-developing children: 1st grade (N\xa0=\xa061, M\xa0=\xa06.46\xa0years, SD\xa0=\xa00.35) and 3rd grade (N\xa0=\xa047, M\xa0=\xa08.5\xa0years, SD\xa0=\xa00.27', 'children aged 6-7 and 8-9\xa0years']","['attention and EF strategy-based training ""Nexxo', 'active-control, or (3) passive-control groups', 'Nexxo-training', 'Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies']","['attention and executive functions', 'Executive Function problems', 'attentional problems']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",108.0,0.0178247,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rossignoli-Palomeque', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain. Electronic address: teresa.rossignoli@ucm.es.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perez-Hernandez', 'Affiliation': 'Department of Development and Educational Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Marqués', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103174']
2300,32919405,Methylphenidate boosts choices of mental labor over leisure depending on striatal dopamine synthesis capacity.,"The cognitive enhancing effects of methylphenidate are well established, but the mechanisms remain unclear. We recently demonstrated that methylphenidate boosts cognitive motivation by enhancing the weight on the benefits of a cognitive task in a manner that depended on striatal dopamine. Here, we considered the complementary hypothesis that methylphenidate might also act by changing the weight on the opportunity cost of a cognitive task, that is, the cost of foregoing alternative opportunity. To this end, 50 healthy participants (25 women) completed a novel cognitive effort-discounting task that required choices between task and leisure. They were tested on methylphenidate, placebo, as well as the selective D2-receptor agent sulpiride, the latter to strengthen inference about dopamine receptor selectivity of methylphenidate's effects. Furthermore, they also underwent an [ 18 F]DOPA PET scan to quantify striatal dopamine synthesis capacity. Methylphenidate boosted choices of cognitive effort over leisure across the group, and this effect was greatest in participants with more striatal dopamine synthesis capacity. The effects of sulpiride did not reach significance. This study strengthens the motivational account of methylphenidate's effects on cognition, and suggests that methylphenidate reduces the cost of mental labor by increasing striatal dopamine.",2020,The effects of sulpiride did not reach significance.,"['50 healthy participants (25 women', 'participants with more striatal dopamine synthesis capacity']","['redo option (methylphenidate or sulpiride minus placebo', 'novel cognitive effort-discounting task that required choices between task and leisure', 'I\u2009=\u2009""ignore', 'methylphenidate, placebo', 'Methylphenidate', 'MPH methylphenidate, SUL sulpiride, PBO placebo', 'placebo', 'methylphenidate']","['PBO placebo, MPH methylphenidate, SUL sulpiride, K i  [ 18 F]DOPA uptake', 'proportion redo choices', '2a Median absolute deviance, b median response times', 'cost of mental labor']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]","[{'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]",50.0,0.0996967,The effects of sulpiride did not reach significance.,"[{'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Hofmans', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands. l.hofmans@donders.ru.nl.'}, {'ForeName': 'Danae', 'Initials': 'D', 'LastName': 'Papadopetraki', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'van den Bosch', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Jessica I', 'Initials': 'JI', 'LastName': 'Määttä', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Monja I', 'Initials': 'MI', 'LastName': 'Froböse', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Bram B', 'Initials': 'BB', 'LastName': 'Zandbelt', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Westbrook', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': 'Department of Psychiatry, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Cools', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00834-1']
2301,32919416,"Sociodemographic, Lifestyle and Medical Factors Associated with Helicobacter Pylori Infection.","BACKGROUND AND AIMS


The prevalence of Helicobacter pylori (H. pylori) infection is higher in developing countries and is often linked to lower socioeconomic status. Few studies have investigated the association between H. pylori and individual level characteristics in Europe, where several countries have a high prevalence of H. pylori infection. The study aimed to identify risk factors for H. pylori infection among adults in a large clinical trial in Latvia.
METHODS


1,855 participants (40-64 years) of the ""Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality"" (GISTAR study) in Latvia tested for H. pylori IgG antibodies were included in a cross-sectional analysis. Sociodemographic, lifestyle and medical factors were compared for participants seropositive (H. pylori+) and seronegative. Mutually adjusted odds ratios (OR) were calculated for H. pylori+ and factors significant in univariate analysis (education, smoking, binge drinking, several dietary habits, history of H. pylori eradication and disease), adjusting for age, gender and income.
RESULTS


Of the participants 1,044 (55.4%) were H. pylori seropositive. The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (OR: 1.32; 95%CI: 1.03-1.69) and inversely with ≥400g vegetables/fruit daily (OR: 0.76; 95%CI: 0.60-0.96), history of H. pylori eradication (OR: 0.57; 95%CI: 0.39-0.84), peptic ulcer (OR: 0.55; 95%CI: 0.38-0.80) and cardiovascular disease (OR: 0.78; 95%CI: 0.61-0.99).
CONCLUSIONS


After mutual adjustment, H. pylori seropositivity was associated with lifestyle and in particular dietary factors rather than socioeconomic indicators in contrast to the majority of other studies.",2020,"The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (","['1,855 participants (40-64 years) of the ""Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality"" (GISTAR study) in Latvia tested for H. pylori IgG antibodies were included in a cross-sectional analysis', 'adults in a large clinical trial in Latvia']",[],"['Helicobacter pylori (H. pylori) infection', 'history of H. pylori eradication ', 'univariate analysis (education, smoking, binge drinking, several dietary habits, history of H. pylori eradication and disease', 'Mutually adjusted odds ratios (OR', 'peptic ulcer', 'cardiovascular disease']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030913', 'cui_str': 'Pepsinogen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1277797', 'cui_str': 'Helicobacter pylori IgG antibody measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",1044.0,0.111375,"The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (","[{'ForeName': 'Danute', 'Initials': 'D', 'LastName': 'Razuka-Ebela', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. d.razuka.ebela@gmail.com.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Polaka', 'Affiliation': 'Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. inese.polaka@gmail.com.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Parshutin', 'Affiliation': 'Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. sergejs.parsutins@lu.lv.'}, {'ForeName': 'Daiga', 'Initials': 'D', 'LastName': 'Santare', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. daiga.santare@lu.lv.'}, {'ForeName': 'Inguna', 'Initials': 'I', 'LastName': 'Ebela', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia. inguna.ebela@gmail.com.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Murillo', 'Affiliation': 'Hospital Universitario San Ignacio, Bogota, Columbia. raulhmurillo@yahoo.com.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. rherrero@acibcr.com.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Tzivian', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia; Holon Institute of Technology, Holon, Israel. liliana.tz@gmail.com.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Young Park', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. ParkJY@iarc.fr.'}, {'ForeName': 'Marcis', 'Initials': 'M', 'LastName': 'Leja', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. marcis.leja@lu.lv.'}]",Journal of gastrointestinal and liver diseases : JGLD,['10.15403/jgld-870']
2302,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION


Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS


A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS


Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS


Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
2303,32920321,Effects of cerebellar transcranial magnetic stimulation on ataxias: A randomized trial.,"INTRODUCTION


Cerebellar ataxia remains a neurological symptom orphan of treatment interventions, despite being prevalent and incapacitating. We aimed to study, in a double-blind design, whether cerebellar modulation could improve ataxia.
METHODS


We included patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia. Patients received five sessions each of sham and active cerebellar 1 Hz deep repetitive transcranial magnetic stimulation in randomized order. Our primary outcome was the decrease in the Scale for the Assessment and Rating of Ataxia when comparing phases (active x sham). Secondary outcomes measures included the International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales. This study was registered at clinicaltrials.gov (protocol NCT03213106).
RESULTS


Twenty-four patients aged 29-74 years were included in our trial. After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002]. The International Cooperative Ataxia Rating Scale score also improved after active stimulation versus sham [median (interquartile range) of 29.0 (21.0, 43.5) versus 32.8 (22.0, 47.0); p = 0.005]. Other secondary outcomes were not significantly modified by stimulation. No patient presented severe side effects, and nine presented mild and self-limited symptoms.
CONCLUSIONS


Our protocol was safe and well-tolerated. These findings suggest that cerebellar modulation may improve ataxic symptom and provide reassurance about safety for clinical practice.",2020,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","['ataxias', 'Twenty-four patients aged 29-74 years', 'patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia']","['Hz deep repetitive transcranial magnetic stimulation', 'cerebellar transcranial magnetic stimulation']","['International Cooperative Ataxia Rating Scale score', 'ataxia', 'ataxic symptom', 'severe side effects', 'International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales', 'safe and well-tolerated', 'Scale for the Assessment and Rating of Ataxia', 'Scale for the Assessment and Rating of Ataxia score']","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024408', 'cui_str': 'Azorean disease'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C4760996', 'cui_str': 'International cooperative ataxia rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}]",24.0,0.653213,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'França', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'de Andrade', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valquíria', 'Initials': 'V', 'LastName': 'Silva', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Galhardoni', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel J', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil; Functional Neurosurgery Division, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens G', 'Initials': 'RG', 'LastName': 'Cury', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil. Electronic address: rubens_cury@usp.br.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.001']
2304,32920476,A brief cognitive behavioural intervention is cost-effective for primary care patients with medically unexplained physical symptoms compared to usual care.,"OBJECTIVE


To assess the cost-effectiveness of a brief cognitive behavioural intervention for patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care.
METHODS


We performed an economic evaluation from a societal perspective alongside a cluster randomised controlled trial with 12 months follow-up. The primary outcome was quality-adjusted life-years (QALYs). Secondary outcomes were the RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS)). Missing data were imputed using multiple imputation. We used non-parametric bootstrapping to estimate statistical uncertainty. The bootstrapped cost-effect pairs were used to estimate cost-effectiveness planes and cost-effectiveness acceptability curves.
RESULTS


Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134). The mean difference in QALYs was 0.01 (95% CI -0.01 to 0.04), in PCS 2.46 (95% CI 1.44 to 3.47), in PHQ-15 -0.26 (95% CI -0.81 to 0.28), and in HADS -0.07 (-0.81 to 0.67). At a willingness to pay of 0 € per additional unit of effect, the probability of the intervention being cost-effective was 0.93 for QALYs and 0.92 for PCS, PHQ-15 and HADS scores.
CONCLUSION


Our intervention is cost-effective compared to usual care for patients with MUPS. Implementation of the intervention has the potential to result in a significant decline in costs. However, large scale implementation would require increased deployment of MHNPs.",2020,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","['patients with MUPS', 'patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care', 'primary care patients with medically unexplained physical symptoms compared to usual care']",['cognitive behavioural intervention'],"['cost-effectiveness', 'quality-adjusted life-years (QALYs', 'RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS', 'cost-effectiveness planes and cost-effectiveness acceptability curves', 'Mean total costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.101801,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sitnikova', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands. Electronic address: e.sitnikova@amsterdamumc.nl.'}, {'ForeName': 'Aureliano P', 'Initials': 'AP', 'LastName': 'Finch', 'Affiliation': 'EuroQol Research Foundation, Marten Meesweg 107, 3068 AV Rotterdam, the Netherlands.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Leone', 'Affiliation': 'Trimbos Institute, Da Costakade 45, 3521 VS Utrecht, the Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Vrije Universiteit Amsterdam, De Boelelaan 1105, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Harm W J', 'Initials': 'HWJ', 'LastName': 'van Marwijk', 'Affiliation': 'Brighton and Sussex Medical School, 94 N - S Rd, Falmer, Brighton BN1 9PX, United Kingdom.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110217']
2305,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
2306,32923882,Clinical Outcomes in Patients With Colon Cancer With Microsatellite Instability of Sporadic or Familial Origin Treated With Adjuvant FOLFOX With or Without Cetuximab: A Pooled Analysis of the PETACC8 and N0147 Trials.,"PURPOSE


The microsatellite instability (MSI) or deficient mismatch repair (dMMR) phenotype is usually regarded as a single biologic entity, given the absence of comparative analyses regarding prognosis and response to chemotherapy between sporadic and familial dMMR cancers.
PATIENTS AND METHODS


Patients with stage III colon cancers were randomly assigned to FOLFOX (leucovorin, fluorouracil, and oxaliplatin) with or without cetuximab in 2 large adjuvant phase III trials (N = 5,577). Among patients with MSI and  KRAS  exon 2 wild-type (WT) tumors, the prognostic and predictive impacts of sporadic versus familial dMMR cancers and  BRAF  V600E mutational status were determined. Multivariable Cox proportional hazards models were used to assess disease-free survival (DFS) by treatment arm, adjusting for age, sex, tumor grade, Eastern Cooperative Oncology Group performance status, pT/pN stage, and primary tumor location.
RESULTS


Among patients with MSI status with complete data for dMMR mechanism analysis (n = 354), 255 (72%) had sporadic ( BRAF  mutation and/or  MLH1  methylation) and 99 (28%) had familial tumors ( BRAF  WT and unmethylated  MLH1  or loss of MSH2/MSH6/PMS2 protein expression). A large proportion of dMMR sporadic tumors were mutated for  BRAF  (n = 200). In patients treated with FOLFOX, DFS did not differ statistically by dMMR mechanism, whereas in patients treated with FOLFOX plus cetuximab, those with sporadic tumors had worse DFS than those with familial cancers (multivariable hazard ratio, 2.69; 95% CI, 1.02 to 7.08;  P  = .04). Considering the predictive utility, the interaction between treatment and dMMR mechanism was significant ( P  = .03). Furthermore, a nonsignificant trend toward a deleterious effect of adding cetuximab to FOLFOX was observed in patients with  BRAF -mutant but not  BRAF  WT tumors.
CONCLUSION


The addition of cetuximab to adjuvant FOLFOX was associated with shorter DFS in patients with sporadic dMMR colon cancer. Additional studies are needed to validate these results in metastatic disease.",2020,"In patients treated with FOLFOX, DFS did not differ statistically by dMMR mechanism, whereas in patients treated with FOLFOX plus cetuximab, those with sporadic tumors had worse DFS than those with familial cancers (multivariable hazard ratio, 2.69; 95% CI, 1.02 to 7.08;  P  = .04).","['Patients with stage III colon cancers', 'Patients With Colon Cancer', 'patients with MSI status with complete data for dMMR mechanism analysis (n = 354), 255 (72%) had sporadic ( BRAF  mutation and/or  MLH1  methylation) and 99 (28%) had familial tumors ( BRAF  WT and unmethylated  MLH1  or loss of MSH2/MSH6/PMS2 protein expression', 'patients with sporadic dMMR colon cancer']","['Cetuximab', 'mismatch repair ', 'cetuximab to adjuvant FOLFOX', 'FOLFOX (leucovorin, fluorouracil, and oxaliplatin) with or without cetuximab', 'FOLFOX plus cetuximab', 'Adjuvant FOLFOX']","['dMMR mechanism', 'DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C1155661', 'cui_str': 'DNA mismatch repair'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0252642', 'cui_str': 'MLH1 protein, human'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1155661', 'cui_str': 'DNA mismatch repair'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C1155661', 'cui_str': 'DNA mismatch repair'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}]",5577.0,0.0380816,"In patients treated with FOLFOX, DFS did not differ statistically by dMMR mechanism, whereas in patients treated with FOLFOX plus cetuximab, those with sporadic tumors had worse DFS than those with familial cancers (multivariable hazard ratio, 2.69; 95% CI, 1.02 to 7.08;  P  = .04).","[{'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Zaanan', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, Sorbonne Université, Université Paris Descartes, Université Paris Diderot, Université Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Meyers', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Smyrk', 'Affiliation': 'Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Julie', 'Affiliation': 'Department of Pathology, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, France.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Zawadi', 'Affiliation': 'Radiotherapy Unit, Departmental Hospital Center, La Roche-Sur-Yon, France.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Mini', 'Affiliation': 'Section of Clinical Pharmacology and Oncology, Department of Health Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, WV.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'First Medical Department, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'Department of Gastroenterology, Erasme Hospital University, Brussels, Belgium.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Department of Statistics, Fédération Francophone de Cancérologie Digestive, Dijon, France.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sargent', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, Sorbonne Université, Université Paris Descartes, Université Paris Diderot, Université Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}]",JCO precision oncology,['10.1200/PO.19.00237']
2307,32923924,Associations between Child and Parent Knowledge of Added Sugar Recommendations and Added Sugar Intake in Multiethnic Elementary-Aged Children.,"Background


A key goal of the Dietary Guidelines for Americans 2015-2020 is to reduce added sugar intake by increasing public knowledge about added sugars. However, research has not shown if knowledge of added sugar recommendations is associated with intake.
Objectives


To determine the relation between parent and child knowledge of added sugar recommendations with added sugar intake in primarily low-income and Hispanic third- to fifth-grade students.
Methods


Analysis examined baseline, cross-sectional data from TX Sprouts, a 1-y cooking, gardening, and nutrition clustered randomized controlled trial. Participants were 685 parent-child dyads from 16 elementary schools in the greater Austin area. Parents and children completed a survey to assess knowledge of added sugar recommendations. Children completed two 24-h dietary recalls to assess average intake of added sugars. Mixed effects linear regression models were used to estimate associations between child and parent knowledge of added sugar recommendations and average total added sugar intake.
Results


Children who correctly identified the added sugar recommendation consumed lower amounts of added sugar compared with children who did not correctly identify the recommendation (34.8 ± 2.7 compared with 41.0 ± 2.5 g;  P  = 0.003), after adjusting for sociodemographic characteristics. Parent knowledge of added sugar recommendations was not associated with child intake.
Conclusions


Child knowledge of added sugar recommendations was associated with lower intake of added sugars. Findings suggest that child nutrition education should focus on increasing knowledge of national recommendations. Future research should investigate a causal relation between added sugar knowledge and intake in elementary-aged children.",2020,"Results


Children who correctly identified the added sugar recommendation consumed lower amounts of added sugar compared with children who did not correctly identify the recommendation (34.8 ± 2.7 compared with 41.0 ± 2.5 g;  P  = 0.003), after adjusting for sociodemographic characteristics.","['primarily low-income and Hispanic third- to fifth-grade students', 'elementary-aged children', 'Multiethnic Elementary-Aged Children', 'Participants were 685 parent-child dyads from 16 elementary schools in the greater Austin area', 'Americans 2015-2020']",[],[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0605411', 'cui_str': 'austin'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],[],,0.053691,"Results


Children who correctly identified the added sugar recommendation consumed lower amounts of added sugar compared with children who did not correctly identify the recommendation (34.8 ± 2.7 compared with 41.0 ± 2.5 g;  P  = 0.003), after adjusting for sociodemographic characteristics.","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Jústiz', 'Affiliation': 'Department of Nutritional Sciences, Dell Pediatric Research Institute, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landry', 'Affiliation': 'Department of Nutritional Sciences, Dell Pediatric Research Institute, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Asigbee', 'Affiliation': 'Department of Nutritional Sciences, Dell Pediatric Research Institute, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghaddar', 'Affiliation': 'Department of Nutritional Sciences, Dell Pediatric Research Institute, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Jeans', 'Affiliation': 'Department of Nutritional Sciences, Dell Pediatric Research Institute, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutritional Sciences, Dell Pediatric Research Institute, The University of Texas at Austin, Austin, TX, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa140']
2308,32923929,Effectiveness of cognitive-behavioral therapy on sexual function and sexual self-efficacy in pregnant women: An RCT.,"Background


Cognitive-behavioral therapy (CBT) is one of the ways to improve an undesirable sexual function.
Objective


The purpose of this study was to investigate the effect of CBT on the sexual function and sexual self-efficacy of pregnant women.
Materials and Methods


In this randomized clinical trial, 36 pregnant women referred to five healthcare centers in Ahvaz, Iran, from December 2016 to January 2017 were enrolled through stratified random sampling in two groups. The case group received counseling based on cognitive behavioral therapy for eight consecutive weeks and the control group received the routine training provided by healthcare staff. Two and four weeks after the end of sessions, both groups completed the Female Sexual Function Index and self-efficacy questionnaires again.
Results


The mean of sexual function and self-efficacy scores in pregnant women in the case and control groups before the intervention did not show a significant difference (p = 0.56). The mean of sexual function and self-efficacy scores of pregnant women in the case and control groups was statistically significant two and four weeks, respectively, after the intervention (p  ≤  0.0001).
Conclusion


The results of this study showed that counseling based on CBT in comparison with the routine training during pregnancy improves the sexual performance and self-efficacy of pregnant women.",2020,The mean of sexual function and self-efficacy scores in pregnant women in the case and control groups before the intervention did not show a significant difference (p = 0.56).,"['36 pregnant women referred to five healthcare centers in Ahvaz, Iran, from December 2016 to January 2017 were enrolled through stratified random sampling in two groups', 'pregnant women']","['CBT', 'routine training provided by healthcare staff', 'counseling based on cognitive behavioral therapy', 'routine training', '\n\n\nCognitive-behavioral therapy (CBT', 'cognitive-behavioral therapy']","['Female Sexual Function Index and self-efficacy questionnaires again', 'sexual performance and self-efficacy', 'mean of sexual function and self-efficacy scores', 'sexual function and sexual self-efficacy']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",36.0,0.0309122,The mean of sexual function and self-efficacy scores in pregnant women in the case and control groups before the intervention did not show a significant difference (p = 0.56).,"[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Nezamnia', 'Affiliation': 'Student Research Committee, Department of Midwifery, Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Reproductive Health Promotion Research Center, Department of Midwifery, Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mehdi Sayah', 'Initials': 'MS', 'LastName': 'Bargard', 'Affiliation': 'Development of Educational Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Latify', 'Affiliation': 'Diabetes Research Center, Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",International journal of reproductive biomedicine,['10.18502/ijrm.v13i8.7504']
2309,32924312,Composite restorations placed in non-carious cervical lesions-Which cavity preparation is clinically reliable?,"The purpose of this in-vivo study was to evaluate the clinical performance of restorations placed in non-carious cervical lesions (NCCLs), using different cavity preparation designs, after 7.7 years. A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin were randomly assigned to the following treatment protocols: dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite. After enamel beveling and selective enamel etching, the defects were restored with composite. The restorations were assessed by two independent, calibrated and blinded investigators, using modified USPHS criteria. At 7 years (7.7 (± 0.35)), a total of 64 restorations (75.3%) were available for follow-up examination. The total retention rate, irrespective of the test groups, was 82.8%. Restorations placed without any preparation showed the highest loss rate (27.8%). Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups. Composites are long-term stable materials for restoring NCCLs. Restorations placed without any dentin preparation (cavity cleaning only) showed the highest loss rate.",2020,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.",['A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin'],"['dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite']","['total retention rate', 'Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration', 'highest loss rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205250', 'cui_str': 'High'}]",85.0,0.0489112,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.","[{'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Lührs', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Jacker-Guhr', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hüsamettin', 'Initials': 'H', 'LastName': 'Günay', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Herrmann', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.310']
2310,32924315,Respiratory nursing care with Angong Niuhuang pill for patients with chronic obstructive pulmonary disease following cardiac surgery.,"AIM


Angong Niuhuang pill (ANP) is a traditional Chinese medicine (TCM) drug widely used for treating stroke. This study aimed to investigate the effect of ANP on respiratory nursing outcomes in chronic obstructive pulmonary disease (COPD) patients following cardiac surgery.
METHODS


A total of 80 COPD patients following cardiac surgery were enrolled and randomized into the control group receiving routine postoperative nursing and ANP group additionally receiving ANP treatment for 3 days (n = 40 for both group). The frequency of back percussion, time of back percussion, amount of expectoration, arterial blood gas levels were compared between groups.
RESULTS


Compared to the control group, the ANP group had a significantly shorter daily mean time of back percussion at day 3 (p = .036) and day 7 (p = .014). The daily mean amount of expectoration was higher at day3 (p = .018) but lower at day 7 (p = .043) in the ANP group than in the control group. In addition, the ANP group had significantly higher hemoglobin saturation (SpO 2  ) and partial pressure of oxygen (PaO 2  ) but lower partial pressure of carbon dioxide (PaCO 2  ) at both day 3 and day 7 than the control group (all p < .05). Furthermore, the time of postoperative aerosol inhalations (p = .041), pulmonary infection rate (p = .025) and postoperative hospital stay (p = .036) were significantly reduced in the ANP group. The ANP group had significantly lower TCM symptom scores at day 3 and day 7 after surgery.
CONCLUSION


These results suggested that ANP treatment can effectively promote the postoperative recovery and respiratory nursing outcomes in COPD patients following cardiac surgery.",2020,The daily mean amount of expectoration was higher at day3 (p = .018) but lower at day 7 (p = .043) in the ANP group than in the control group.,"['COPD patients following cardiac surgery', '80 COPD patients following cardiac surgery', 'patients with chronic obstructive pulmonary disease following cardiac surgery', 'chronic obstructive pulmonary disease (COPD) patients following cardiac surgery']","['Respiratory nursing care with Angong Niuhuang pill', 'ANP', 'control group receiving routine postoperative nursing and ANP group additionally receiving ANP treatment', 'Niuhuang pill (ANP']","['TCM symptom scores', 'daily mean amount of expectoration', 'pulmonary infection rate', 'hemoglobin saturation (SpO 2  ) and partial pressure of oxygen (PaO 2  ) but lower partial pressure of carbon dioxide (PaCO 2  ', 'postoperative hospital stay', 'frequency of back percussion, time of back percussion, amount of expectoration, arterial blood gas levels', 'postoperative recovery and respiratory nursing outcomes', 'time of postoperative aerosol inhalations', 'shorter daily mean time of back percussion']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C4507707', 'cui_str': 'Angong Niuhuang Pill'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3490173', 'cui_str': 'niuhuang'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",80.0,0.0657858,The daily mean amount of expectoration was higher at day3 (p = .018) but lower at day 7 (p = .043) in the ANP group than in the control group.,"[{'ForeName': 'Linhua', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Gynecology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Bijiao', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fengjiao', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Division of Cardiovascular Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of Cardiac Surgery, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Cuiyu', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiac Surgery, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhongkai', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiac Surgery, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Kangni', 'Initials': 'K', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiac Surgery, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12344']
2311,32919454,Respiratory effects of acute milk consumption among asthmatic and non-asthmatic children: a randomized controlled study.,"BACKGROUND


A commonly held public belief is that cow's milk products increase mucus production and respiratory symptoms. Dietary milk elimination is often attempted despite lack of evidence. Our objective was to investigate whether a single exposure to cow's milk is associated with respiratory symptoms and changes in pulmonary functions in asthmatic and non-asthmatic children.
METHODS


We conducted a prospective double blind, placebo-controlled trial on non-asthmatic and asthmatic children aged 6-18 years evaluated at a pediatric pulmonology unit. The children were randomly challenged with cow's milk or soy milk substitute. Symptoms, spirometry, fractional-exhaled nitric-oxide (FeNO), and pulse oximetry findings were obtained at baseline and at 30, 60, 90, and 120 min following challenge. A two-way ANCOVA (with repeated measures when required) was used to compare the performances of all groups and subgroups over time. The outcome measures of each participant were compared to his/her own variables over time and in relation to his/her baseline values. In case of missing data points, missingness analysis was performed using Little's missing completely at random (MCAR) test.
RESULTS


Fifty non-asthmatic children (26 assigned to the cow's milk group and 24 to the soy substitute group), and 46 asthmatic children (22 in the cow's milk group and 24 in the soy substitute group) were enrolled. Age, gender, and body mass index Z-score were comparable between the two groups. No changes in symptoms, spirometry, FeNO, or oxygen saturation measurements were observed following challenge in any of the participants in both groups, at any time point compared to baseline.
CONCLUSIONS


A single exposure to cow's milk is not associated with symptoms, bronchial inflammation, or bronchial constriction in both non-asthmatic and asthmatic children. Our findings do not support the strict elimination of dairy products from a child's diet for the prevention of respiratory symptoms.
TRIAL REGISTRATION


This study was approved by the Tel Aviv Sourasky Medical Center Institutional Review Board and the Israeli Ministry of Health review board (Helsinki Committee, NIH #NCT02745899). Registered April 2016 https://clinicaltrials.gov/ct2/show/NCT02745899?cond=milk+asthma&rank=1 .",2020,"No changes in symptoms, spirometry, FeNO, or oxygen saturation measurements were observed following challenge in any of the participants in both groups, at any time point compared to baseline.
","['non-asthmatic and asthmatic children aged 6-18\xa0years evaluated at a pediatric pulmonology unit', 'acute milk consumption among asthmatic and non-asthmatic children', ""Fifty non-asthmatic children (26 assigned to the cow's milk group and 24 to the soy substitute group), and 46 asthmatic children (22 in the cow's milk group and 24 in the soy substitute group) were enrolled"", 'asthmatic and non-asthmatic children']","['placebo', ""cow's milk or soy milk substitute""]","['Symptoms, spirometry, fractional-exhaled nitric-oxide (FeNO), and pulse oximetry findings', 'his/her own variables over time and in relation to his/her baseline values', 'symptoms, bronchial inflammation, or bronchial constriction', 'symptoms, spirometry, FeNO, or oxygen saturation measurements']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1635023', 'cui_str': 'Pediatric pulmonology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0452741', 'cui_str': 'Soya milk'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",,0.0862151,"No changes in symptoms, spirometry, FeNO, or oxygen saturation measurements were observed following challenge in any of the participants in both groups, at any time point compared to baseline.
","[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Koren', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv-Yafo, Israel.""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Armoni Domany', 'Affiliation': 'Pediatric Pulmonary Unit, The Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Gut', 'Affiliation': ""Pediatric Pulmonary Institute, Ruth Children's Hospital, Rambam Health, Care Campus, Haifa, Israel.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadanny', 'Affiliation': 'The Mina and Everard Goodman Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Benor', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv-Yafo, Israel.""}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tavor', 'Affiliation': ""Dana-Dwek Children's Hospital, Tel Aviv-Yafo, Israel.""}, {'ForeName': 'Yakov', 'Initials': 'Y', 'LastName': 'Sivan', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. sivan@tauex.tau.ac.il.'}]",BMC pediatrics,['10.1186/s12887-020-02319-y']
2312,32919517,"Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Cytomegalovirus is a common congenital infection, with high morbidity after an early primary maternal infection. No effective means exist to prevent viral transmission to the fetus. We aimed to investigate whether valaciclovir can prevent vertical transmission of cytomegalovirus to the fetus in pregnant women with a primary infection acquired early in pregnancy.
METHODS


This prospective, randomised, double-blind, placebo-controlled trial was done at the Infectious Feto-Maternal Clinic of Rabin Medical Center (Petach Tikvah, Israel). Pregnant women aged 18 years or older, with serological evidence of a primary cytomegalovirus infection acquired either periconceptionally or during the first trimester of pregnancy, were randomly assigned to oral valaciclovir (8 g per day, twice daily) or placebo from enrolment until amniocentesis at 21 or 22 gestational weeks. Randomisation was done separately for participants infected periconceptionally or during the first trimester and was done in blocks of four. Patients and researchers were masked to participant allocation throughout the entire study period. The primary endpoint was the rate of vertical transmission of cytomegalovirus. Statistical analyses were done according to per-protocol principles. The study was registered at ClinicalTrials.gov, NCT02351102.
FINDINGS


Between Nov 15, 2015, and Oct 8, 2018, we enrolled and randomly assigned 100 patients to receive valaciclovir or placebo. Ten patients were excluded, five from each study group; therefore, the final analysis included 45 patients (all singletons) in the valaciclovir group and 45 patients (43 singletons and two sets of twins) in the placebo group. In the valaciclovir group, including both first trimester and periconceptional infections, five (11%) of 45 amniocenteses were positive for cytomegalovirus, compared with 14 (30%) of 47 amniocenteses in the placebo group (p=0·027; odds ratio 0·29, 95% CI 0·09-0·90 for vertical cytomegalovirus transmission). Among participants with a primary cytomegalovirus infection during the first trimester, a positive amniocentesis for cytomegalovirus was significantly less likely in the valaciclovir group (two [11%] of 19 amniocenteses) compared with the placebo group (11 [48%] of 23 amniocenteses; p=0·020. No clinically significant adverse events were reported.
INTERPRETATION


Valaciclovir is effective in reducing the rate of fetal cytomegalovirus infection after maternal primary infection acquired early in pregnancy. Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
FUNDING


None.",2020,"Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
","['pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus', 'pregnant women with a primary infection acquired early in pregnancy', 'Ten patients were excluded, five from each study group; therefore, the final analysis included 45 patients (all singletons) in the valaciclovir group and 45 patients (43 singletons and two sets of twins) in the placebo group', 'Pregnant women aged 18 years or older, with serological evidence of a primary cytomegalovirus infection acquired either periconceptionally or during the first trimester of pregnancy', 'cytomegalovirus after maternal primary infection during pregnancy', 'Infectious Feto-Maternal Clinic of Rabin Medical Center (Petach Tikvah, Israel', 'Between Nov 15, 2015, and Oct 8, 2018, we enrolled and randomly assigned 100 patients to receive']","['valaciclovir or placebo', 'Valaciclovir', 'valaciclovir', 'placebo', 'oral valaciclovir']","['rate of vertical transmission of cytomegalovirus', 'positive amniocentesis for cytomegalovirus', 'rate of fetal cytomegalovirus infection', 'adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0948192', 'cui_str': 'Primary infection NOS'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242648', 'cui_str': 'Vertical infection transmission'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.675587,"Early treatment of pregnant women with primary infection might prevent termination of pregnancies or delivery of infants with congenital cytomegalovirus.
","[{'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Shahar-Nissan', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: kerens411@gmail.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pardo', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Peled', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Irit', 'Initials': 'I', 'LastName': 'Krause', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Efraim', 'Initials': 'E', 'LastName': 'Bilavsky', 'Affiliation': 'Department of Pediatrics ""C"", Schneider Children\'s Medical Center of Israel, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Arnon', 'Initials': 'A', 'LastName': 'Wiznitzer', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Hadar', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Amir', 'Affiliation': 'Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikvah, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31868-7']
2313,32919893,A 3-Day residential yoga-based program improves education professionals' psychological and occupational health in a single arm trial.,"OBJECTIVE


This study examined changes in psychological and occupational health in urban education professionals after attending a brief yoga-based program.
METHODS


Education professionals from the New York City Department of Education (NYC DOE) who were attending a residential 3-day yoga-based program at Kripalu Center for Yoga & Health were recruited to participate in the study. Measures of psychological and occupational health and health-related behaviors were completed before (baseline), after (post), and two months after the program (follow-up). Paired samples t-tests were used to compare scores between time points.
RESULTS


At post, participants (N = 74) showed improvements in stress, resilience, affect, mindfulness, empowerment, self-compassion, satisfaction with life, work engagement, burnout, exercise, and vegetable intake (all p values < 0.05) compared to baseline. At the follow-up (N = 33), showed improvements in resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout (all p values < 0.05) compared to baseline. There were significant correlations between the degree of home practice of the skills and techniques learned in the program and improvements in multiple measures of psychological and occupational health at follow-up (all p values < 0.05).
CONCLUSIONS


These findings suggest that the yoga-based program improves psychological and occupational health and healthy behaviors in education professionals immediately following the program and up to two-months following the program, however, more data with larger sample sizes are needed to confirm sustained benefits over the longer term.",2020,"At the follow-up (N = 33), showed improvements in resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout (all p values < 0.05) compared to baseline.","['urban education professionals after attending a brief yoga-based program', 'Education professionals from the New York City Department of Education (NYC DOE) who were attending a residential 3-day yoga-based program at Kripalu Center for Yoga & Health were recruited to participate in the study']",['3-Day residential yoga-based program'],"['psychological and occupational health and healthy behaviors', 'psychological and occupational health and health-related behaviors', 'multiple measures of psychological and occupational health', 'resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout', 'stress, resilience, affect, mindfulness, empowerment, self-compassion, satisfaction with life, work engagement, burnout, exercise, and vegetable intake', ""education professionals' psychological and occupational health""]","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C4505268', 'cui_str': 'Employee Engagement'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0013647', 'cui_str': 'Professional Education'}]",,0.0171417,"At the follow-up (N = 33), showed improvements in resilience, affect, mindfulness, empowerment, self-compassion, work engagement, and burnout (all p values < 0.05) compared to baseline.","[{'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Dyer', 'Affiliation': 'Kripalu Center for Yoga & Health, Stockbridge MA, USA. Electronic address: natalieleighdyer@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Kripalu Center for Yoga & Health, Stockbridge MA, USA.'}, {'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Dusek', 'Affiliation': 'Kripalu Center for Yoga & Health, Stockbridge MA, USA.'}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston MA, USA.""}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.08.018']
2314,32919894,Benefits of hand massage on anxiety in preoperative outpatient: A quasi-experimental study with pre- and post-tests.,"CONTEXT


Surgical patients experience procedure-related anxiety preoperatively. With delays and long waiting periods, surgical patients can experience increased anxiety and decreased satisfaction with their hospital visit.
MAIN OBJECTIVES


To evaluate whether a 15-minute non-therapeutic hand massage provided by the Caring Hands massage volunteers would reduce anxiety levels, increase satisfaction, and decrease physiological parameters among preoperative surgical patients.
DESIGN


This research study has a quasi-experimental design, with control and intervention groups, and pre and post-tests.
SETTING


This research study was conducted at Same Day Surgical Stations 53 and 63 at the Mayo Clinic Hospital, Methodist Campus, in Rochester Minnesota.
PATIENTS


One hundred and thirty-eight surgical outpatients were recruited preoperatively, with 31 participants in the control group and 107 in the intervention group.
INTERVENTIONS


Patients in the control group were asked to rest for 15 min. Patients in the intervention group received a 15-minute non-therapeutic hand massage administered by the Caring Hands massage volunteers from the Mayo Clinic Volunteer Program.
MAIN OUTCOME MEASURES


Patient anxiety level and physiological parameters were measured and recorded before and after a resting session (control group) or a 15-minute non-therapeutic hand massage session (intervention group). Patients in the intervention group were also surveyed for satisfaction. The feasibility of incorporating a 15-minute non-therapeutic hand massage into the preoperative routine was also analyzed.
RESULTS


After receiving a 15-minute non-therapeutic hand massage, patients experienced reduced anxiety levels and increased satisfaction. It was also found that it is feasible to add a 15-minute non-therapeutic hand massage to the routine of a same-day surgical station.",2020,Patient anxiety level and physiological parameters were measured and recorded before and after a resting session (control group) or a 15-minute non-therapeutic hand massage session (intervention group).,"['preoperative surgical patients', 'This research study was conducted at Same Day Surgical Stations 53 and 63 at the Mayo Clinic Hospital, Methodist Campus, in Rochester Minnesota', 'One hundred and thirty-eight surgical outpatients were recruited preoperatively, with 31 participants in the control group and 107 in the intervention group', 'Surgical patients experience procedure-related anxiety preoperatively']","['15-minute non-therapeutic hand massage administered by the Caring Hands massage volunteers from the Mayo Clinic Volunteer Program', 'hand massage']","['anxiety levels, increase satisfaction', 'anxiety', 'Patient anxiety level and physiological parameters', 'anxiety levels and increased satisfaction']","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0337739', 'cui_str': 'Methodist Church'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",138.0,0.0153519,Patient anxiety level and physiological parameters were measured and recorded before and after a resting session (control group) or a 15-minute non-therapeutic hand massage session (intervention group).,"[{'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Mayo Clinic School of Health Sciences, Doctorate of Nurse Anesthesia Practice Program, Seibens 10, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: li.zhihong@mayo.edu.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Bauer', 'Affiliation': 'Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Aaberg', 'Affiliation': 'Division of Volunteer Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pool', 'Affiliation': 'Same Day Surgical Stations 53 and 63, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Van Rooy', 'Affiliation': 'Division of Volunteer Program, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'Schroeder', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Finney', 'Affiliation': 'Mayo Clinic School of Health Sciences, Doctorate of Nurse Anesthesia Practice Program, Seibens 10, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.08.016']
2315,32919897,"Dextrose prolotherapy versus radial extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: A randomized, controlled clinical trial.","In the recent years, prolotherapy is increasingly being used in the field of musculoskeletal medicine. However, few studies have investigated its effectiveness in plantar fasciitis (PF). The purpose of this study was to compare the effectiveness of ultrasound-guided dextrose prolotherapy with radial extracorporeal shock wave therapy (ESWT) in the treatment of chronic PF. This randomized controlled trial was conducted on 59 patients with chronic PF. Patients were randomly assigned into two groups receiving three sessions of radial ESWT (29 patients) vs. two sessions of ultrasound-guided intrafascial 2 cc dextrose 20% injection (30 patients). The following outcome measures were assessed before and then six weeks and 12 weeks after the treatments: pain intensity by visual analog scale (VAS), daily life and exercise activities by Foot and Ankle Ability Measure (FAAM), and the plantar fascia thickness by ultrasonographic imaging. The VAS and FAAM scales showed significant improvements of pain and function in both study groups 6 weeks and 12 weeks after the treatments. A significant reduction was noted for plantar fascia thickness at these intervals (all p < .05). The inter-group comparison revealed that except for the FAAM-sport subscale which favored ESWT, the interaction effects of group and time were not significant for other outcome measures. Dextrose prolotherapy has comparable efficacy to radial ESWT in reducing pain, daily-life functional limitation, and plantar fascia thickness in patients with PF. No serious adverse effects were observed in either group. LEVEL OF EVIDENCE: Level I, randomized controlled trial.",2020,The VAS and FAAM scales showed significant improvements of pain and function in both study groups 6 weeks and 12 weeks after the treatments.,"['patients with PF', 'chronic PF', '59 patients with chronic PF', 'chronic plantar fasciitis']","['Dextrose prolotherapy', 'radial ESWT', 'radial extracorporeal shock wave therapy', 'ultrasound-guided dextrose prolotherapy with radial extracorporeal shock wave therapy (ESWT', 'ultrasound-guided intrafascial 2 cc dextrose 20% injection']","['plantar fascia thickness', 'serious adverse effects', 'pain and function', 'pain intensity by visual analog scale (VAS), daily life and exercise activities by Foot and Ankle Ability Measure (FAAM), and the plantar fascia thickness by ultrasonographic imaging', 'pain, daily-life functional limitation, and plantar fascia thickness', 'FAAM-sport subscale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C1136148', 'cui_str': 'Fasciitis, Plantar, Chronic'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]",59.0,0.103734,The VAS and FAAM scales showed significant improvements of pain and function in both study groups 6 weeks and 12 weeks after the treatments.,"[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Asheghan', 'Affiliation': 'Exercise Physiology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran. Electronic address: m_asheghan@bmsu.ac.ir.'}, {'ForeName': 'Seyed Ebrahim', 'Initials': 'SE', 'LastName': 'Hashemi', 'Affiliation': 'Exercise Physiology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Hollisaz', 'Affiliation': 'Exercise Physiology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peiman', 'Initials': 'P', 'LastName': 'Roumizade', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Morteza', 'Initials': 'SM', 'LastName': 'Hosseini', 'Affiliation': 'Medicine, Quran and Hadith Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghanjal', 'Affiliation': 'Health Management Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.08.008']
2316,32919912,Associations Between Depressive Symptoms and HFpEF-Related Outcomes.,"OBJECTIVES


This study analyzed changes in depressive symptoms in patients with heart failure and preserved ejection fraction (HFpEF) who were enrolled in the TOPCAT (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function) trial.
BACKGROUND


There are limited longitudinal data for depressive symptoms in patients with HFpEF.
METHODS


In patients enrolled in the United States and Canada (n = 1,431), depressive symptoms were measured using Patient Health Questionnaire-9 (PHQ-9). Clinically meaningful changes in PHQ-9 scores were defined as worse (≥3-point increase) or better (≥3-point decrease). Multivariate models were used to identify predictors of change in depressive symptoms. Cox proportional hazard models were used to determine the impact of symptom changes from baseline on subsequent incident cardiovascular events.
RESULTS


At 12 months, 19% of patients experienced clinically worsening depressive symptoms, 31% better, and 49% unchanged. Independent predictors of clinically meaningful improvement in depressive symptoms included higher baseline PHQ-9 scores, male sex, lack of chronic obstructive pulmonary disease, and randomization to spironolactone. After data were adjusted for cardiovascular comorbidities, higher baseline PHQ-9 was associated with all-cause mortality (hazard ratio [HR]: 1.09; 95% confidence interval [CI]: 1.02 to 1.16; p = 0.011), whereas worsening depressive symptoms at 12 months were associated with cardiovascular death (HR: 2.47; 95% CI: 1.32 to 4.63; p = 0.005) and all-cause mortality (HR: 1.82; 95% CI: 1.13 to 2.93; p = 0.014). Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
CONCLUSIONS


Higher baseline depressive symptoms and worsening depressive symptoms were associated with all-cause mortality. Randomization to spironolactone was associated with modest reduction in depressive symptoms. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302).",2020,"Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
","['patients with HFpEF', 'patients with heart failure and preserved ejection fraction (HFpEF) who were enrolled in the', 'for Adults With Heart\xa0Failure and Preserved Systolic Function) trial']","['Aldosterone Antagonist Therapy', 'TOPCAT (Aldosterone Antagonist Therapy', 'spironolactone']","['baseline PHQ-9 scores, male sex, lack of chronic obstructive pulmonary disease', 'baseline depressive symptoms and worsening depressive symptoms', 'clinically worsening depressive symptoms', 'depressive symptoms', 'PHQ-9 scores', 'cardiovascular death', 'worsening depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.485354,"Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': 'Cardiology Division, University of Texas Southwestern, Dallas, Texas.'}, {'ForeName': 'Michael A D', 'Initials': 'MAD', 'LastName': 'Alcala', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Heitner', 'Affiliation': 'New York Presbyterian-Brooklyn Methodist Hospital, New York, New York.'}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto, California. Electronic address: eflewis@stanford.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.010']
2317,32919914,Similar Yet Different: Examining the Effects of Sacubitril/Valsartan by Race in the PIONEER-HF Trial.,,2020,,[],['Sacubitril/Valsartan'],[],[],"[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]",[],,0.0216378,,"[{'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Advocate Heart Institute and Edward Hospital Center for Advanced Heart Failure, Naperville, Illinois. Electronic address: mariarosa.costanzo@aah.com.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.002']
2318,32919915,Angiotensin-Neprilysin Inhibition in Black Americans: Data From the PIONEER-HF Trial.,"OBJECTIVES


This study compared the efficacy and safety of sacubitril/valsartan to enalapril in Black and non-Black Americans with acute decompensated heart failure (ADHF).
BACKGROUND


Black patients have a different response to treatment with angiotensin-converting enzyme inhibitors compared with other racial and ethnic groups. How Black patients with ADHF respond to sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, is unclear. PIONEER-HF was a double-blind randomized clinical trial of sacubitril/valsartan versus enalapril in hospitalized patients with ADHF following hemodynamic stabilization.
METHODS


In a pre-specified subgroup analysis, we examined changes in N-terminal pro-B-type natriuretic peptide, clinical outcomes, and safety according to race.
RESULTS


The study population, all enrolled in the United States, included 316 (36%) Black participants, 515 (58%) White participants, and 50 (5.7%) participants of other racial groups. The reduction in N-terminal pro-B-type natriuretic peptide concentration at weeks 4 and 8 was significantly greater with sacubitril/valsartan than enalapril in both Black (ratio of change with sacubitril/valsartan vs. enalapril: 0.71; 95% confidence interval [CI]: 0.58 to 0.88) and non-Black patients (ratio of change: 0.71; 95% CI: 0.61 to 0.83; interaction p = 1.00). Compared with enalapril, sacubitril/valsartan also reduced the pre-specified exploratory composite of cardiovascular death or HF rehospitalization in both Black (hazard ratio: 0.47; 95% CI: 0.24 to 0.93) and non-Black patients (hazard ratio: 0.65; 95% CI: 0.40 to 1.06; interaction p = 0.44).
CONCLUSIONS


Among Black patients admitted with ADHF in the United States, the in-hospital initiation of sacubitril/valsartan was more effective than enalapril in reducing natriuretic peptide levels and the composite of cardiovascular death or HF rehospitalization. The effect of sacubitril/valsartan did not differ by race. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,The reduction in N-terminal pro-B-type natriuretic peptide concentration at weeks 4 and 8 was significantly greater with sacubitril/valsartan than enalapril in both Black (ratio of change with sacubitril/valsartan vs. enalapril: 0.71; 95% confidence interval [CI]: 0.58 to 0.88) and non-Black patients (ratio of change: 0.71; 95% CI: 0.61 to 0.83; interaction p = 1.00).,"['The study population, all enrolled in the United States, included 316 (36', 'Patients', 'White participants, and 50 (5.7%) participants of other racial groups', 'Black participants, 515 (58', 'Black Americans', 'Black patients', 'Black patients admitted with ADHF in the United States', 'Black and non-Black Americans with acute decompensated heart failure (ADHF', 'hospitalized patients with ADHF following hemodynamic stabilization', 'How Black patients with ADHF respond to']","['sacubitril/valsartan', 'Angiotensin-Neprilysin Inhibition', 'angiotensin-converting enzyme inhibitors', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril, sacubitril/valsartan', 'enalapril']","['reduction in N-terminal pro-B-type natriuretic peptide concentration', 'efficacy and safety', 'NT-proBNP', 'natriuretic peptide levels and the composite of cardiovascular death or HF rehospitalization', 'pre-specified exploratory composite of cardiovascular death or HF rehospitalization']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.173707,The reduction in N-terminal pro-B-type natriuretic peptide concentration at weeks 4 and 8 was significantly greater with sacubitril/valsartan than enalapril in both Black (ratio of change with sacubitril/valsartan vs. enalapril: 0.71; 95% confidence interval [CI]: 0.58 to 0.88) and non-Black patients (ratio of change: 0.71; 95% CI: 0.61 to 0.83; interaction p = 1.00).,"[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Berardi', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Hillary S', 'Initials': 'HS', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Terrence X', 'Initials': 'TX', 'LastName': ""O'Brien"", 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center, South Carolina, Charleston; Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California; Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, North Carolina. Electronic address: adam.devore@duke.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.019']
2319,32920022,Subgroup analysis of the ASPirin in Reducing Events in the Elderly randomized clinical trial suggest aspirin did not improve outcomes in older adults with chronic kidney disease.,"The role of aspirin for primary prevention in older adults with chronic kidney disease (CKD) is unclear. Therefore, post hoc analysis of the randomized controlled trial ASPirin in Reducing Events in the Elderly (ASPREE) was undertaken comparing 100 mg of enteric-coated aspirin daily against matching placebo. Participants were community dwelling adults aged 70 years and older in Australia, 65 years and older in the United States, all free of a history of dementia or cardiovascular disease and of any disease expected to lead to death within five years. CKD was defined as present at baseline if either eGFR under 60mL/min/1.73m 2  or urine albumin to creatinine ratio 3 mg/mmol or more. In 4758 participants with and 13004 without CKD, the rates of a composite endpoint (dementia, persistent physical disability or death), major adverse cardiovascular events and clinically significant bleeding in the CKD participants were almost double those without CKD. Aspirin's effects as estimated by hazard ratios were generally similar between CKD and non-CKD groups for dementia, persistent physical disability or death; major adverse cardiovascular events and clinically significant bleeding. Thus, in our analysis aspirin did not improve outcomes in older people while increasing the risk of bleeding, with mostly consistent effects in participants with and without CKD.",2020,"Aspirin's effects as estimated by hazard ratios were generally similar between CKD and non-CKD groups for dementia, persistent physical disability or death; major adverse cardiovascular events and clinically significant bleeding.","['Participants were community dwelling adults aged 70 years and older in Australia, 65 years and older in the United States, all free of a history of dementia or cardiovascular disease and of any disease expected to lead to death within five years', 'older adults with chronic kidney disease', 'older adults with chronic kidney disease (CKD', '4758 participants with and 13004 without CKD']","['Aspirin', 'ASPirin', 'enteric-coated aspirin daily against matching placebo', 'aspirin']","['rates of a composite endpoint (dementia, persistent physical disability or death), major adverse cardiovascular events and clinically significant bleeding', 'risk of bleeding', 'physical disability or death; major adverse cardiovascular events', 'hazard ratios']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0455499', 'cui_str': 'H/O: dementia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4758.0,0.0866962,"Aspirin's effects as estimated by hazard ratios were generally similar between CKD and non-CKD groups for dementia, persistent physical disability or death; major adverse cardiovascular events and clinically significant bleeding.","[{'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Wetmore', 'Affiliation': 'Department of Medicine, Hennepin Healthcare Systems, Minneapolis, Minnesota, USA; Hennepin Healthcare Research Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Gallagher', 'Affiliation': 'Epsom and St Helier University Hospitals NHS Trust, London UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Roderick', 'Affiliation': 'University of Southampton and Southampton General Hospital, Hampshire, UK.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, Illinois, U.S.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, U.S.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Abhayaratna', 'Affiliation': 'College of Medicine, Biology and Environment, Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mahady', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""Sticht Center on Healthy Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, U.S.""}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Department of Medicine, Hennepin Healthcare Systems, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Nephrology, Monash Medical Centre, Monash Health, Melbourne, Victoria, Australia. Electronic address: kevan.polkinghorne@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2020.08.011']
2320,32920032,IS MEATAL ANALGESIA NECESSARY FOR PAIN REDUCTION DURING CYSTOSCOPY IN FEMALES? A PROSPECTIVE RANDOMISED STUDY.,"OBJECTIVES


To evaluate whether anesthesia of the meatal orifice reduces pain during cystoscopy in women, known to cause significant pain, discomfort and anxiety in women. Secondary end-point was to compare pain between rigid and flexible cystoscopy.
METHODS


A total of 120 women, median age 66 (IQR 57-69), referred for office cystoscopy were prospectively randomized into two groups according to meatal orifice exposure: (1) 5 minute meatus exposure with 2% lidocaine gel; (2) 5 minute meatal exposure with water soluble gel. In each group a pad soaked by the gel was externally placed on the meatal orifice. Each group was further divided to flexible or rigid cystoscopy. Exclusion criteria included: urethral stricture, urinary tract infection, chronic pain disease (e.g. IC/PBS), neurogenic disorder, allergy to lubricant and concurrent pain medication. In all patients, a water based lubricant applied on the cystoscope, was used for lubrication. A 0-10 visual analogue scale (VAS) was performed at four checkpoints: before examination, immediately following urethral penetration, immediately at end of procedure and 15 minutes after completion.
RESULTS


Study groups did not significantly differ in clinical or demographic parameters. Pain level prior to procedure was 0 in all patients. Mean VAS immediately after urethral penetration was 4.2±2.3 in both groups 1 and 2 (p=1). No significant differences in other checkpoints was reported. Further sub-analysis by cystoscope type did not demonstrate significance.
CONCLUSIONS


Meatal analgesia does not increase tolerance to cystoscopy in females. Pain level is not reduced by the use of flexible cystoscope in the female population.",2020,Mean VAS immediately after urethral penetration was 4.2±2.3 in both groups 1 and 2 (p=1).,"['women', 'Exclusion criteria included: urethral stricture, urinary tract infection, chronic pain disease (e.g. IC/PBS), neurogenic disorder, allergy to lubricant and concurrent pain medication', 'females', '120 women, median age 66 (IQR 57-69), referred for office cystoscopy']","['flexible or rigid cystoscopy', 'meatal orifice exposure: (1) 5 minute meatus exposure with 2% lidocaine gel; (2) 5 minute meatal exposure with water soluble gel', 'flexible cystoscope']","['Mean VAS', 'pain between rigid and flexible cystoscopy', 'Pain level', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180275', 'cui_str': 'Flexible cystoscope'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",120.0,0.0496774,Mean VAS immediately after urethral penetration was 4.2±2.3 in both groups 1 and 2 (p=1).,"[{'ForeName': 'Yishai H', 'Initials': 'YH', 'LastName': 'Rappaport', 'Affiliation': 'Departments of Urology, Shamir Medical Center, Zerifin, Israel. Electronic address: rappaport.urology@gmail.com.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Beberashvili', 'Affiliation': 'Departments of Nephrology, Sackler School of Medicine, Tel Aviv University, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Zisman', 'Affiliation': 'Departments of Urology, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Kobi', 'Initials': 'K', 'LastName': 'Stav', 'Affiliation': 'Departments of Urology, Shamir Medical Center, Zerifin, Israel.'}]",Urology,['10.1016/j.urology.2020.08.052']
2321,32920065,DNA methylation of hypertension-related genes and effect of riboflavin supplementation in adults stratified by genotype for the MTHFR C677T polymorphism.,"BACKGROUND


The interaction between genetic, epigenetic and environmental factors plays an important role in the aetiology of hypertension. GWAS and observational studies link the C677T polymorphism in methylenetetrahydrofolate reductase (MTHFR) with hypertension, while riboflavin, the MTHFR cofactor, has been shown to reduce blood pressure and global DNA methylation in homozygous (TT genotype) individuals. It is currently unclear whether riboflavin modulates DNA methylation of other hypertension-related genes.
OBJECTIVES


To compare DNA methylation of hypertension-related genes in adults stratified by MTHFR genotype and effect of riboflavin intervention in adults with the variant MTHFR 677TT genotype.
METHOD


Pyrosequencing was carried out for hypertension-related genes (ACE, AGTR1, GCK, GNA12, IGF2, MMP9 and NOS3) in blood samples from participants in previous trials (CC, n = 40; TT, n = 40). The effect of intervention with riboflavin (1.6 mg/d for16 weeks) or placebo on DNA methylation was investigated in adults with the variant MTHFR 677TT genotype (n = 80).
RESULTS


Individuals with the MTHFR 677TT v CC genotype had significantly higher average DNA methylation at NOS3 (+1.66%, P = 0.044). In response to riboflavin supplementation in TT individuals, there was an increase in average DNA methylation at IGF2 (+1.09%, P = 0.019) and a decrease at ACE (-0.44%, P = 0.021) in females only. Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
CONCLUSION


This study provides the first RCT evidence that riboflavin alters DNA methylation of hypertension-related genes in adults with the MTHFR 677TT genotype, providing some insight into mechanisms linking hypertension with the genotype-specific response of BP to riboflavin.",2020,"Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
","['homozygous (TT genotype) individuals', 'adults with the variant MTHFR 677TT genotype', 'adults with the MTHFR 677TT genotype', 'adults with the variant MTHFR 677TT genotype (n\u202f=\u202f80']","['riboflavin', 'placebo', 'riboflavin intervention', 'riboflavin supplementation']","['blood pressure and global DNA methylation', 'DNA methylation', 'average DNA methylation at IGF2', 'average DNA methylation at NOS3']","[{'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate reductase (NADPH)'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4524020', 'cui_str': 'Riboflavin supplementation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C1569730', 'cui_str': 'insulin-like growth factor 2, human'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}]",,0.0498317,"Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
","[{'ForeName': 'Sophia D', 'Initials': 'SD', 'LastName': 'Amenyah', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK; Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McMahon', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Deane', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'McNulty', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Strain', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Horigan', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Purvis', 'Affiliation': 'Department of Cardiology, Altnagelvin Area Hospital, BT47 6SB, N. Ireland, UK.'}, {'ForeName': 'Colum P', 'Initials': 'CP', 'LastName': 'Walsh', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Diane J', 'Initials': 'DJ', 'LastName': 'Lees-Murdock', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK. Electronic address: dj.lees@ulster.ac.uk.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.011']
2322,32921911,"Comparative evaluation of clinical outcome of indirect pulp treatment with calcium hydroxide, calcium silicate and Er,Cr:YSGG laser in permanent molars.","Background


The aim of the study was to compare preservation of pulp vitality by indirect pulp treatment with calcium hydroxide, calcium silicate based cement (Biodentine) and Er,Cr:YSGG laser in permanent molars.
Materials and methods


30 patients were selected for this study as per the inclusion and exclusion criteria in the age group of 6-14 years and then randomly allocated to three groups A, B & C. In group A, after caries excavation, calcium hydroxide (Dycal) was placed at the floor. In group B, after caries excavation, calcium silicate based cement (Biodentine) was placed at the floor. In group C, after caries excavation, decontamination of the cavity was done with Er,Cr:YSGG laser. This was followed by placement of permanent restorative material in all the groups. Clinical and radiographic success was monitored at 3, 6 and months. Data analysis was performed using Statistical Package for the Social Science-21 (SPSS-21).
Results


At the end of 9 months, overall success rate of indirect pulp was 86.6%. There was no significant difference between the three groups. (p > 0.05).
Conclusion


The study showed that the success of indirect pulp treatment is independent of the type of liner used for pulp capping. Moreover, the study also shows that Er,Cr;YSGG laser can be effectively used for indirect pulp capping procedures.",2019,The study showed that the success of indirect pulp treatment is independent of the type of liner used for pulp capping.,"['30 patients were selected for this study as per the inclusion and exclusion criteria in the age group of 6-14 years', 'permanent molars']","['calcium silicate based cement (Biodentine', 'Cr;YSGG laser', 'calcium hydroxide (Dycal', 'Er,Cr:YSGG laser', 'calcium hydroxide, calcium silicate based cement (Biodentine', 'indirect pulp treatment with calcium hydroxide, calcium silicate and Er,Cr:YSGG laser']","['overall success rate of indirect pulp', 'Clinical and radiographic success', 'pulp vitality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0058830', 'cui_str': 'Dycal'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",30.0,0.0243347,The study showed that the success of indirect pulp treatment is independent of the type of liner used for pulp capping.,"[{'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'E', 'Affiliation': 'Pedodontics & Preventive Dentistry, Maulana Azad Institute of Dental Sciences New Delhi.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Gyanendra', 'Affiliation': 'Pedodontics & Preventive Dentistry, Maulana Azad Institute of Dental Sciences New Delhi.'}, {'ForeName': 'Jatinder Kaur', 'Initials': 'JK', 'LastName': 'Dhillon', 'Affiliation': 'Pedodontics & Preventive Dentistry, Maulana Azad Institute of Dental Sciences New Delhi.'}]",Laser therapy,['10.5978/islsm.19-OR-09']
2323,32921912,"The effects of Er:YAG, Nd:YAG, and Diode (940nm) Lasers irradiation on Microtensile bond strength of two steps self-etch adhesives.","Background and aims


Nowadays, studies show the effective laser irradiation role on the adhesion of bonding agents to the dentin. Therefore, the present study was set to find an appropriate protocol for the use of Nd:YAG, Er:YAG, and Diode lasers during the application of two steps self-etch adhesives in direct dental restorations in order to achieve higher microtensile strength.
Materials and Methods


A total number of 100 extracted healthy teeth were selected. After removing occlusal enamel and exposing dentin, samples randomly divided into ten groups: Group Control (C), two steps self-etch adhesives was applied in accordance with the manufacturer instructions, without using laser systems; Groups Er-YAG, laser (2940 nm, 10 Hz, 0.4w, 40 mJ) irradiated Before applying Primer (Er-BP subgroup), After applying Primer (Er-AP subgroup), After applying Bonding (Er-AB subgroup); Groups Nd-YAG, laser (1064 nm, 10 Hz, 1.2w, 40 mJ) irradiated Before applying Primer (Nd-BP subgroup), After applying Primer (Nd-AP subgroup), After applying Bonding (Nd-AB subgroup); Groups Diode, laser (940 nm, 10 Hz, 0.7w, 70 mJ) irradiated Before applying Primer (D-BP subgroup), After applying Primer (D-AP subgroup), After applying Bonding (D-AB subgroup). After intervention and composite build up, the samples were stored 24 hours in 37°C distilled water. The microtensile strength was measured using the universal testing machine. The data were analyzed by one-way ANOVA test and post hoc Tukey test. (p < 0.05).
Results


The Means and standard deviations of the groups were as follow: C = 30.09 ± 4.21, Er-BP = 18.83 ± 4.21, Er-AP = 14.43 ± 3.12, Er-AB = 19.67 ± 4.96, Nd-BP = 20.35 ± 5.55, Nd-AP = 39.85 ± 4.13, Nd-AB = 18.16 ± 3.36, D-BP = 26.74 ± 5.05, D-AP = 28.11 ± 5.12, D-AB = 37.28 ± 5.61. The mean microtensile strength achieved in groups: Nd-AP and D-AB were significantly higher than control group (p < 0.05). Groups D-BP and D-AP had no significant difference in comparison with control group while the remaining groups had significantly lower values (P < 0.05).
Conclusions


Nd:YAG laser irradiation after applying the primer, and diode laser irradiation after applying the bonding agent, both can improve the microtensile bond strength in two steps self-etch adhesive systems significantly.",2019,The mean microtensile strength achieved in groups: Nd-AP and D-AB were significantly higher than control group (p < 0.05).,['A total number of 100 extracted healthy teeth'],"['Er:YAG, Nd:YAG, and Diode (940nm) Lasers irradiation']","['mean microtensile strength', 'microtensile strength', 'microtensile bond strength']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",100.0,0.0182289,The mean microtensile strength achieved in groups: Nd-AP and D-AB were significantly higher than control group (p < 0.05).,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Resaei-Soufi', 'Affiliation': 'Dental Research Center, Dental School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ghanadan', 'Affiliation': 'Dental Caries Prevention Research Center, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moghimbeigi', 'Affiliation': 'Dept. of biostatistics, Public health school, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Laser therapy,['10.5978/islsm.19-OR-10']
2324,32921945,Preoperative external rotation deficit does not predict poor outcomes or lack of improvement after reverse total shoulder arthroplasty.,"Introduction


The purpose was to compare postoperative outcomes and functional improvement between patients with preoperative aER deficits vs. preserved aER function.
Results


There were 115 patients in the <0° aER group and 314 in the ≥30° aER group. Preoperative patients in the <0° group were worse for all measures except subjective pain while post-operatively, they had significantly greater improvement for all measures of motion. Postoperatively, both groups achieved comparable scores for forward elevation, pain, SST and ASES.
Conclusion


This study demonstrates that patients with a complete aER deficit can recover substantial and comparable function after RTSA.",2020,"Preoperative patients in the <0° group were worse for all measures except subjective pain while post-operatively, they had significantly greater improvement for all measures of motion.","['patients with preoperative aER deficits vs. preserved aER function', '115 patients in the <0° aER group and 314 in the ≥30° aER group']",[],"['forward elevation, pain, SST and ASES', 'subjective pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1112870', 'cui_str': 'Drug aerosol'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037659', 'cui_str': 'Somatostatin'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.0208529,"Preoperative patients in the <0° group were worse for all measures except subjective pain while post-operatively, they had significantly greater improvement for all measures of motion.","[{'ForeName': 'Moby', 'Initials': 'M', 'LastName': 'Parsons', 'Affiliation': 'The Knee, Hip and Shoulder Center, Portsmouth, NH, USA.'}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Routman', 'Affiliation': 'Atlantis Orthopedics, Palm Beach, FL, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Roche', 'Affiliation': 'Exactech Inc., Gainesville, FL, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Friedman', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of orthopaedics,['10.1016/j.jor.2020.08.018']
2325,32921979,Epithelial Remodeling Following Phacoemulsification in Diabetic Patients Using Anterior-Segment Optical Coherence Tomography: A Comparative Study.,"Purpose


To compare the effect of phacoemulsification on corneal epithelial thickness in diabetic and nondiabetic cataract patients.
Methods


Fifty eyes with cataracts were enrolled in a prospective comparative interventional study. They were divided into two groups: group A (diabetics) and group B (nondiabetics) and underwent uneventful phacoemulsification. Epithelial thickness was assessed in the central, paracentral, and peripheral cornea on the first day and at 1 week, 1 month, and 3 months postoperatively using spectral-domain ocular coherence tomography.
Results


A significant increase in the first-day postoperative central epithelial thickness was noticed in both groups (57.16±3.5 µm and 55.96±2.81 µm in groups A and B, respectively), with increased baseline epithelial thickness of 3.8±2.1 µm and 3.4±2.14 µm in groups A and B, respectively ( P <0.001). A significant decrease in epithelial thickness was noticed in both groups after 1 week (-2.40±3.1 µm and -2.76±2.71 µm in group A and B, respectively). No further significant change was noticed in the nondiabetic group at 1 month; however, significant reductions in for central epithelial thickness were found in the diabetic group up to the first month (-0.80±1.9 µm,  P =0.05). Central corneal thickness followed the same pattern of change as the epithelium. A nonsignificant delay in visual acuity improvement was noticed in diabetic patients.
Conclusion


Phacoemulsification induces a temporary increase in corneal and epithelial thickness that should resolve by the first week postoperatively. However, diabetic patients had slower epithelial recovery that took up to 1 month, which could be reflected in delayed visual recovery with no effect on the final visual outcome.",2020,"A significant decrease in epithelial thickness was noticed in both groups after 1 week (-2.40±3.1 µm and -2.76±2.71 µm in group A and B, respectively).","['Diabetic Patients Using Anterior-Segment Optical Coherence Tomography', 'diabetic patients', 'diabetic and nondiabetic cataract patients', 'Methods\n\n\nFifty eyes with cataracts']","['phacoemulsification', 'Epithelial Remodeling Following Phacoemulsification', 'uneventful phacoemulsification']","['Epithelial thickness', 'corneal epithelial thickness', 'slower epithelial recovery', 'central epithelial thickness', 'Central corneal thickness', 'epithelial thickness', 'corneal and epithelial thickness', 'delayed visual recovery', 'first-day postoperative central epithelial thickness', 'visual acuity improvement', 'baseline epithelial thickness']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",50.0,0.0151676,"A significant decrease in epithelial thickness was noticed in both groups after 1 week (-2.40±3.1 µm and -2.76±2.71 µm in group A and B, respectively).","[{'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Elmekawey', 'Affiliation': 'Ophthalmology, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Abdelaziz', 'Affiliation': 'Ophthalmology, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Baradey', 'Affiliation': 'Ophthalmology, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Kotb', 'Affiliation': 'Ophthalmology, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S266464']
2326,32921980,Reduction of Intraocular Pressure Spikes Due to Intravitreal Bevacizumab Injections by Scleral Indentation with Cotton Swab or Digital Ocular Massage: Innovative Techniques Compared.,"Purpose


This study aims to evaluate the effectiveness of different decompressive injection techniques in reducing intraocular pressure (IOP) spikes, if compared to the injection without pressure applied on the eye, following the intravitreal injection of bevacizumab.
Patients and Methods


Two hundred patients with indication to intravitreal therapy were randomized into five arms: 40 received intravitreal injection without ocular decompression (arm A), 40 with pre-injection scleral indentation with cotton swab (arm B), 40 with pre-injection digital ocular massage (arm C), 40 with post-injection scleral indentation with cotton swab (arm D) and 40 with post-injection digital ocular massage (arm E). All patients underwent measurement of the IOP with Goldamm applanation tonometer 10 minutes before and 10 minutes after the injection. The primary endpoint of the study was variation of the post- injection IOP with the different techniques.
Results


An increase in post-injection IOP was observed in all the arms, if compared to pre-injection values. The greatest increase was observed in arm A with a mean IOP rise of 17.60 mmHg. All other techniques showed lower mean IOP increases: arm B 10.76 mmHg, arm C 9.35 mmHg, arm D 8.8 mmHg, arm E 3.4 mmHg. The post-injection IOP differences of innovative techniques compared to the technique without ocular decompression were all statistically significant ( p -value <0.01). If compared to arm A (35%), a reduction in IOP spike ≥40 mmHg frequency was also observed. The status of phakia/pseudophakia, a previous diagnosis of glaucoma and the underlying pathology for which indication was given to inject bevacizumab did not significantly alter the post-injection IOP in any of the protocols.
Conclusion


The introduction of new injection protocols, such as injections performed before or after decompressive treatments, could be a safe and effective approach to control post-injection IOP increase.",2020,"All other techniques showed lower mean IOP increases: arm B 10.76 mmHg, arm C 9.35 mmHg, arm D 8.8 mmHg, arm E 3.4 mmHg.",['Patients and Methods\n\n\nTwo hundred patients with indication to intravitreal therapy'],"['Intravitreal Bevacizumab', 'intravitreal injection without ocular decompression (arm A), 40 with pre-injection scleral indentation with cotton swab (arm B), 40 with pre-injection digital ocular massage (arm C), 40 with post-injection scleral indentation with cotton swab (arm D) and 40 with post-injection digital ocular massage (arm E', 'bevacizumab', 'Cotton Swab or Digital Ocular Massage', 'decompressive injection techniques']","['post-injection IOP', 'IOP spike ≥40 mmHg frequency', 'intraocular pressure (IOP) spikes', 'mean IOP rise', 'post- injection IOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0423271', 'cui_str': 'Scleral injection'}, {'cui': 'C0332467', 'cui_str': 'Indentation'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",200.0,0.0296152,"All other techniques showed lower mean IOP increases: arm B 10.76 mmHg, arm C 9.35 mmHg, arm D 8.8 mmHg, arm E 3.4 mmHg.","[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Nuzzi', 'Affiliation': 'Eye Clinic, Department of Surgical Sciences, University of Turin, AOU Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Scalabrin', 'Affiliation': 'Eye Clinic, Department of Surgical Sciences, University of Turin, AOU Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Becco', 'Affiliation': 'Eye Clinic, Department of Surgical Sciences, University of Turin, AOU Città della Salute e della Scienza, Turin, Italy.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S263474']
2327,32921984,Video Education Reduces Pain and Anxiety Levels in Cancer Patients Who First Use Fentanyl Transdermal Patch: A Randomized Controlled Trial.,"Objective


We sought to evaluate the efficacy of using a quick response (QR) code within video education to guide proper use of fentanyl transdermal patches and control pain, depression, and anxiety levels in cancer patients.
Methods


Patients using a fentanyl transdermal patch for the first time were enrolled in the study and then given an information leaflet as well as an informed consent form. We asked them to complete the first questionnaire (Q1) prior to first use of the fentanyl transdermal patch, and then used a random number table to randomize those who completed it into two groups. Participants in group A received a QR code (to make it easier for them to obtain additional video information) and a traditional information leaflet, whereas those in group B (control group) only received a traditional information leaflet. Thereafter, we requested all participants to complete standard questionnaires, which comprised a Numeric Rating Scale (NRS), a Spielberger State-Trait Anxiety Inventory (STAI), as well as a Hospital Anxiety and Depression Scale (HADS). The resulting continuous (with a normal distribution) and categorical data were analyzed using Student's  t - and chi-square tests, respectively. We also recorded parameters such as NRS, STAI, and HADS, as well as the frequency of rescue medication in both groups.
Results


A total of 154 cancer patients who first used a fentanyl transdermal patch were recruited during the study period, from April to May 2020. Among these, 138 completed follow-up, with 70 and 68 in group A and B, respectively. Participants in both groups had similar baseline and clinical characteristics, whereas significant differences were observed between the groups with regard to the other parameters. Specifically, participants in group A recorded a lower STAI state (38.2 vs 38.9,  P =0.027) and HADS (3.9 vs 4.2,  P =0.001) anxiety scores, as well as NRS (2.1 vs 2.4,  P =0.025) and frequency of rescue medication (0.4 vs 1.4,  P <0.001) than those in group B, following 14 days of using a fentanyl transdermal patch.
Conclusion


Our results indicated that incorporating a QR code within additional video education leads to proper use of a fentanyl transdermal patch and relieves pain and anxiety levels in patients with cancer. Based on this, we recommend a new style of education during care of cancer patients who first use a fentanyl transdermal patch.",2020,"Specifically, participants in group A recorded a lower STAI state (38.2 vs 38.9,  P =0.027) and HADS (3.9 vs 4.2,  P =0.001) anxiety scores, as well as NRS (2.1 vs 2.4,  P =0.025) and frequency of rescue medication (0.4 vs 1.4,  P <0.001) than those in group B, following 14 days of using a fentanyl transdermal patch.
","['Cancer Patients', 'cancer patients', '154 cancer patients who first used a fentanyl transdermal patch were recruited during the study period, from April to May 2020', 'patients with cancer']","['fentanyl transdermal patch', 'Video Education', 'quick response (QR) code within video education', 'traditional information leaflet', 'Fentanyl Transdermal Patch', 'QR code']","['Numeric Rating Scale (NRS), a Spielberger State-Trait Anxiety Inventory (STAI), as well as a Hospital Anxiety and Depression Scale (HADS', 'pain and anxiety levels', 'Pain and Anxiety Levels', 'control pain, depression, and anxiety levels', 'anxiety scores', 'frequency of rescue medication', 'HADS', 'lower STAI state']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1301808', 'cui_str': 'State'}]",154.0,0.0462972,"Specifically, participants in group A recorded a lower STAI state (38.2 vs 38.9,  P =0.027) and HADS (3.9 vs 4.2,  P =0.001) anxiety scores, as well as NRS (2.1 vs 2.4,  P =0.025) and frequency of rescue medication (0.4 vs 1.4,  P <0.001) than those in group B, following 14 days of using a fentanyl transdermal patch.
","[{'ForeName': 'Ziqi', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Pharmacy, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}, {'ForeName': 'Zixue', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': ""Department of Pharmacy, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, People's Republic of China.""}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': ""Department of Pharmacy, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, People's Republic of China.""}, {'ForeName': 'Yuefeng', 'Initials': 'Y', 'LastName': 'Rao', 'Affiliation': ""Department of Clinical Pharmacy, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S264112']
2328,32921985,Effectiveness of Metoprolol in Improving Cardiac and Motor Functions in Patients with Chronic Heart Failure: A Prospective Study.,"Purpose


To assess gender-, age-, and the dose-related influence of metoprolol on cardiac function, motor function, quality-of-life (QoL), and mental status in Chinese chronic heart failure (CHF) patients.
Patients and Methods


This single-center, prospective study enrolled CHF patients with resting heart rate (HR) >80 bpm and used metoprolol continuous release tablets. Patients were initiated with 12.5-mg metoprolol. All patients were assessed for change in cardiac function, motor function, QoL, and mental status according to gender (men vs women), age (<60 vs ≥60 years), and metoprolol dose administered (47.5 mg [n=37], 71.25 mg [n=7], 118.75 [n=74], and 142.5 mg [n=19]).
Results


Overall, 154 CHF patients (101 men and 53 women), with median age 66.39 years, were enrolled. In total, 116 and 38 patients were aged ≥60 and <60 years, respectively. We observed a slight decrease in systolic blood pressure (SBP) in women compared with men. HR had increased with an increase in ejection fraction (EF) from baseline to 1 month (35.24±6.15 and 34.79±6.25) and increased to 50.00±4.45 and 50.72±4.09 among both the genders. Cardiac index (CI) and motor function had improved along with better QoL after metoprolol treatment in both the genders. In both age groups (<60 and ≥60 years), improvement in cardiac function, motor function, and QoL was observed; however, there was a difference in mental status. The dose effect of metoprolol on cardiac function, motor function, QoL, and mental status showed a gradual decrease in EF with dose increments, with no change in CI. Motor function, QoL, and mental status did not show much difference with uptitration of metoprolol dose.
Conclusion


Psychological responses to metoprolol treatment differ with gender, with no age-related changes in terms of cardiac function, motor function, QoL, or mental status, except increases in depression, burnout, and anxiety.",2020,Cardiac index (CI) and motor function had improved along with better QoL after metoprolol treatment in both the genders.,"['Chinese chronic heart failure (CHF) patients', '154 CHF patients (101 men and 53 women), with median age 66.39 years, were enrolled', 'enrolled CHF patients with resting heart rate (HR) >80 bpm and used metoprolol continuous release tablets', 'women compared with men', 'according to gender (men vs women), age (<60 vs ≥60 years), and metoprolol dose administered (47.5 mg [n=37', 'Patients with Chronic Heart Failure', 'In total, 116 and 38 patients were aged ≥60 and <60 years, respectively']","['Metoprolol', 'metoprolol']","['cardiac function, motor function, QoL, and mental status', 'Cardiac and Motor Functions', 'ejection fraction (EF', 'Cardiac index (CI) and motor function', 'systolic blood pressure (SBP', 'cardiac function, motor function, and QoL', 'Motor function, QoL, and mental status', 'cardiac function, motor function, QoL, or mental status', 'depression, burnout, and anxiety', 'cardiac function, motor function, quality-of-life (QoL), and mental status']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",154.0,0.0384143,Cardiac index (CI) and motor function had improved along with better QoL after metoprolol treatment in both the genders.,"[{'ForeName': 'XiaoLiang', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""Department of Endocrinology, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiology, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""School of Public Health, Kunming Medical University, Kunming, Yunnan, People's Republic of China.""}, {'ForeName': 'Zhenxia', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': ""Department of Cardiology, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': ""Department of Cardiology, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S263026']
2329,32921989,"Ketamine Enhances Intranasal Dexmedetomidine-Induced Sedation in Children: A Randomized, Double-Blind Trial.","Purpose


To compare the efficacy of intranasal dexmedetomidine and dexmedetomidine-ketamine premedication in preschool children undergoing tonsillectomy.
Patients and Methods


We enrolled 66 children with American Society of Anesthesiologists physical status I or II, aged 3-7 years undergoing tonsillectomy. Patients were randomly allocated to receive intranasal premedication with either dexmedetomidine 2 μg kg -1  (Group D) or dexmedetomidine 2 μg kg -1  and ketamine 2 mg kg -1  (Group DK). The primary outcome was the sedation level assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) 30 min after intervention. The minimal clinically relevant difference in the MOAA/S score was 0.5. Secondary outcomes included sedation onset time, parental separation anxiety, acceptance of mask induction, emergence time, emergence delirium, postoperative pain intensity, length of stay in the post-anesthesia care unit (PACU), and adverse effects.
Results


At 30 min after premedication, the MOAA/S score was lower in Group DK than in Group D patients (median: 1.0, interquartile range [IQR]: 1.0-2.0 vs median: 3.0, IQR: 2.0-3.0;  P <0.001), with a median difference of 1.0 (95% confidence interval [CI]: 1.0-2.0,  P <0.001). Patients in Group DK showed considerably faster onset of sedation (15 min, 95% CI: 14.2-15.8 min) than Group D (24 min, 95% CI: 23.2-24.8 min), with a median difference of 8.0 min (95% CI: 7.0-9.0 min,  P <0.001). Both parental separation and facemask acceptance scores were lower in Group DK than in Group D patients ( P =0.012 and  P =0.001, respectively). There was no significant difference in emergence time, incidence of emergence delirium, postoperative pain scores, and length of stay in the PACU between the two groups.
Conclusion


Intranasal premedication with a combination of dexmedetomidine and ketamine produced better sedation for pediatric tonsillectomy than dexmedetomidine alone.",2020,"There was no significant difference in emergence time, incidence of emergence delirium, postoperative pain scores, and length of stay in the PACU between the two groups.
","['preschool children undergoing tonsillectomy', '66 children with American Society of Anesthesiologists physical status I or II, aged 3-7 years undergoing tonsillectomy', 'Children']","['Dexmedetomidine-Induced Sedation', 'Ketamine', 'dexmedetomidine 2 μg kg -1  and ketamine', 'dexmedetomidine and ketamine', 'intranasal dexmedetomidine', 'dexmedetomidine', 'dexmedetomidine-ketamine premedication']","['faster onset of sedation', 'emergence time, incidence of emergence delirium, postoperative pain scores, and length of stay in the PACU', 'parental separation and facemask acceptance scores', ""sedation level assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S"", 'MOAA/S score', 'sedation onset time, parental separation anxiety, acceptance of mask induction, emergence time, emergence delirium, postoperative pain intensity, length of stay in the post-anesthesia care unit (PACU), and adverse effects']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0003477', 'cui_str': 'Separation anxiety'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",66.0,0.572182,"There was no significant difference in emergence time, incidence of emergence delirium, postoperative pain scores, and length of stay in the PACU between the two groups.
","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesiology, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': ""Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Zihan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S269765']
2330,32921992,Effects of an Alveolar Recruitment Maneuver During Lung Protective Ventilation on Postoperative Pulmonary Complications in Elderly Patients Undergoing Laparoscopy.,"Purpose


Controversy remains over whether alveolar recruitment maneuvers (ARMs) can reduce postoperative pulmonary complications. We hypothesized that performing an ARM in addition to lung protective ventilation (LPV) could improve intraoperative arterial oxygenation and postoperative pulmonary complications (PPCs) in elderly patients undergoing laparoscopy in the Trendelenburg position.
Patients and Methods


Sixty-two patients (aged 65-85) scheduled for laparoscopic low anterior resection were randomized to receive LPV only (LPV group, n = 32) or LPV with an ARM (ARM group, n = 30). LPV was set to a tidal volume of 6 mL/kg with a positive end expiratory pressure (PEEP) of 5 cmH 2 O. The ARM was performed by serially increasing the PEEP to 10 cmH 2 O for 3 breaths, 15 cmH 2 O for 3 breaths, then 20 cmH 2 O for 10 breaths, both immediately before and after abdominal insufflation. The primary end-point was the frequency of PPCs such as desaturation (SpO 2  <90%), atelectasis, and pneumonia. Secondary end-points were changes in intraoperative respiratory and gas exchange parameters and hemodynamic variables.
Results


One patient in the LPV group experienced desaturation on the first postoperative day. The frequency of chest X-ray abnormalities such as atelectasis or pleural effusion was comparable between groups (6 (19%) and 5 (17%) patients, respectively, P = 0.676). Changes in other respiratory, gas exchange and hemodynamic parameters over time were not significantly different between the groups. However, vasopressor requirements during surgery were higher in the ARM than the LPV group (9 (30%) and 2 (6%) patients, respectively, P = 0.014).
Conclusion


This study suggests that performing an ARM during LPV may not improve postoperative respiratory outcomes and intraoperative oxygenation compared to LPV alone in geriatric patients undergoing laparoscopy in the Trendelenburg position. In addition, since the ARM could cause a significant deterioration in hemodynamic parameters, applying ARM to elderly patients should be carefully considered.",2020,"Changes in other respiratory, gas exchange and hemodynamic parameters over time were not significantly different between the groups.","['geriatric patients undergoing laparoscopy in the Trendelenburg position', 'Patients and Methods\n\n\nSixty-two patients (aged 65-85) scheduled for laparoscopic low anterior resection', 'Elderly Patients Undergoing Laparoscopy', 'elderly patients undergoing laparoscopy in the Trendelenburg position']","['lung protective ventilation (LPV', 'Alveolar Recruitment Maneuver', 'Lung Protective Ventilation', 'alveolar recruitment maneuvers (ARMs', 'LPV alone', 'LPV only (LPV group, n = 32) or LPV with an ARM (ARM', 'LPV']","['frequency of chest X-ray abnormalities such as atelectasis or pleural effusion', 'frequency of PPCs such as desaturation (SpO 2  <90%), atelectasis, and pneumonia', 'Postoperative Pulmonary Complications', 'vasopressor requirements', 'intraoperative arterial oxygenation and postoperative pulmonary complications (PPCs', 'intraoperative respiratory and gas exchange parameters and hemodynamic variables']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0277812', 'cui_str': 'Trendelenburg position'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0807932,"Changes in other respiratory, gas exchange and hemodynamic parameters over time were not significantly different between the groups.","[{'ForeName': 'Youn Yi', 'Initials': 'YY', 'LastName': 'Jo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Kyung Cheon', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Jongchul', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.'}]",Clinical interventions in aging,['10.2147/CIA.S264987']
2331,32922017,"A Prospective, Randomized and Controlled Study on Tissue Adhesive for Skin Incision in Total Knee Arthroplasty.","Background


The study focusing on the tissue adhesive in total knee arthroplasty (TKA) was rare. This study aimed to evaluate the clinical outcomes and economic costs of tissue adhesive when acting as the adjunct to standard incision closure in TKA.
Patients and Methods


From September 2019 to November 2019, we prospectively enrolled the consecutive patients who underwent simultaneous bilateral TKA in our institute. The allocation using the tissue adhesive was done after the subcuticular suture in right knee first and another method was applied in the left knee automatically. The patients' demographics, length of stay (LOS), times of dressing changes and incision-related cost, range of motion (ROM), incision-related complications and incision evaluation scores were recorded.
Results


Thirty-two patients were enrolled in this study and followed at two months after surgery. In the knees of tissue adhesive, the times of dressing change and patient scar assessment scores (PSAS) were significantly less than those standard skin closure (p=0.000; p=0.003). Although there were no significant differences of the delayed discharge, incision-related cost, ROM, incision-related complications and Vancouver scar score (VSS) between two groups, 65.6% (21/32) patients preferred the tissue adhesive and only 15.6% (5/32) patients preferred the standard incision closure.
Conclusion


Tissue adhesive could effectively reduce postoperative wound drainage and improve patients' satisfaction rate with no difference in medical costs and ROM in TKA. The application of tissue adhesive and subcuticular sutures might be one safe and convenient method of skin closure in TKA.
Chinese Clinical Trial Registry


ChiCTR1900025730; Registered 6 September 2019.",2020,"Although there were no significant differences of the delayed discharge, incision-related cost, ROM, incision-related complications and Vancouver scar score (VSS) between two groups, 65.6% (21/32) patients preferred the tissue adhesive and only 15.6%","['total knee arthroplasty (TKA', 'Thirty-two patients were enrolled in this study and followed at two months after surgery', 'Total Knee Arthroplasty', 'From September 2019 to November 2019, we prospectively enrolled the consecutive patients who underwent simultaneous bilateral TKA in our institute']",['Tissue Adhesive for Skin Incision'],"['times of dressing change and patient scar assessment scores (PSAS', 'delayed discharge, incision-related cost, ROM, incision-related complications and Vancouver scar score (VSS', 'length of stay (LOS), times of dressing changes and incision-related cost, range of motion (ROM), incision-related complications and incision evaluation scores']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",32.0,0.0175502,"Although there were no significant differences of the delayed discharge, incision-related cost, ROM, incision-related complications and Vancouver scar score (VSS) between two groups, 65.6% (21/32) patients preferred the tissue adhesive and only 15.6%","[{'ForeName': 'Xiangpeng', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': ""Department of Orthopaedics, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Renwen', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Orthopaedics, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedics, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': ""Department of Orthopaedics, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Chinese PLA General Hospital, Beijing, People's Republic of China.""}]",Therapeutics and clinical risk management,['10.2147/TCRM.S260007']
2332,32922068,Infection Risk of Lumbar Epidural Injection in the Operating Theatre Prior to Lumbar Fusion Surgery.,"Purpose


To determine the association between preoperative lumbar epidural injections (LEIs) in the operating theater (OR) and the occurrence of surgical site infection (SSI) after posterior lumbar instrumented fusion surgery.
Methods


This study was performed from January 2015 to September 2019. We enrolled 2312 patients who underwent lumbar surgery without LEIs (control group) and 469 patients who underwent lumbar surgery after LEIs in the OR. We further separated the patients by the time interval between the LEIs and surgery: 1) for the 0-1 M group, lumbar surgery was performed within 1 month after the LEIs, and 2) for the >1 M group, it was performed more than 1 month after the LEIs.
Results


The postoperative infection rate in the 0-1 M group was considerably higher than that in the control group ( p  = 0.0101). We further subdivided the 0-1 M and >1 M groups into four subgroups: a) the 0-1 MNS group included patients in the 0-1 M group who did not receive steroids; b) the 0-1 MS group who received steroids; c) the >1 MNS group included patients in the >1 M group who did not receive steroids; d) the >1 MS group who received steroids. The postoperative infection rate in the 0-1 MS subgroup was considerably higher than that in the control group ( p  = 0.0018). However, the infection rate was lower in the >1 MS subgroup ( p  = 0.1650). There were no statistically significant differences in the postoperative infection rate between the control group and the two non-steroid groups (0-1 MNS group,  p  = 0.4961; 1 MNS group,  p  = 0.7381).
Conclusion


The administration of LEIs without steroids in the OR before lumbar instrumented fusion does not significantly increase patients' risk of postoperative infection. We recommend avoiding steroid injections administered within 1 month before lumbar instrumented fusion.",2020,"There were no statistically significant differences in the postoperative infection rate between the control group and the two non-steroid groups (0-1 MNS group,  p  = 0.4961; 1 MNS group,  p  = 0.7381).
","['2312 patients who underwent lumbar surgery without LEIs (control group) and 469 patients who underwent lumbar surgery after LEIs in the OR', 'January 2015 to September 2019']","['LEIs without steroids', 'steroids', 'Lumbar Epidural Injection', 'preoperative lumbar epidural injections (LEIs', 'MNS group included patients in the 0-1 M group who did not receive steroids; b) the 0-1 MS group who received steroids; c) the >1 MNS group included patients in the >1 M group who did not receive steroids']","['infection rate', ""patients' risk of postoperative infection"", 'postoperative infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0581283', 'cui_str': 'Injection into lumbar epidural space'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}]","[{'cui': 'C0581283', 'cui_str': 'Injection into lumbar epidural space'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0025237', 'cui_str': 'Melnick-Needles syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}]",2312.0,0.0164647,"There were no statistically significant differences in the postoperative infection rate between the control group and the two non-steroid groups (0-1 MNS group,  p  = 0.4961; 1 MNS group,  p  = 0.7381).
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, The Second Affiliated Hospital of Luohe Medical College, Luohe, Henan 462300, People's Republic of China.""}, {'ForeName': 'Xiuwei', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ""Department of Orthopedics, The Second Affiliated Hospital of Luohe Medical College, Luohe, Henan 462300, People's Republic of China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': ""Department of Orthopedics, The Second Affiliated Hospital of Luohe Medical College, Luohe, Henan 462300, People's Republic of China.""}, {'ForeName': 'Xiaochen', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, The Second Affiliated Hospital of Luohe Medical College, Luohe, Henan 462300, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S261922']
2333,32922100,Effect of Cardiac Rehabilitation on Hope Among Cardiac Patients After Coronary Artery Bypass Graft Surgery.,"Purpose


Following coronary artery bypass graft (CABG) surgery, some patients experience psycho-mental problems such as hopelessness. The Phase 2 cardiac rehabilitation (CR) program is an important element of the secondary prevention program in treating patients with cardiovascular disease (CVD). The present study aimed to determine the effect of the Phase 2 CR program on the level of hope in cardiac patients after CABG surgery.
Patients and Methods


A clinical trial was conducted from July 2017 to late January 2018 at the Heart Surgery Centre, Al-Zahra Hospital, Shiraz, Iran. The target population was patients who sought CR therapy after CABG surgery. A total of 104 cardiac patients were recruited and equally divided into control and intervention groups. The intervention group received 20 sessions of Phase 2 CR program combined with education and counselling during 8 weeks. The control group only received routine observations and education. The data were collected pre- and post-intervention using a demographic form and the Miller Hope Scale (MHS). Descriptive statistics were expressed as percentages, frequency distribution, mean and standard deviation. Paired  t -test and independent  t -test were used for statistical inference. Data were analyzed using the SPSS statistical software (version 23.0) and P values <0.05 were considered statistically significant.
Results


There was no significant difference in the mean score of hope between the control and intervention groups before the intervention. However, a significant difference between the groups was observed post-intervention (P<0.001). The results showed a significant difference in the mean score of hope between pre-intervention (182.36±23.07) and post-intervention (216.94±23.05) in the intervention group (P<0.001), whereas the difference in the control group was not significant (P=0.095). The measured post-intervention effect size was high (1.05).
Conclusion


The Phase 2 CR program combined with education and counseling increased hope in CVD patients after CABG surgery.",2020,There was no significant difference in the mean score of hope between the control and intervention groups before the intervention.,"['CVD patients after CABG surgery', 'Cardiac Patients', 'Patients and Methods\n\n\nA clinical trial was conducted from July 2017 to late January 2018 at the Heart Surgery Centre, Al-Zahra Hospital, Shiraz, Iran', '104 cardiac patients', 'patients with cardiovascular disease (CVD', 'cardiac patients after CABG surgery']","['routine observations and education', 'cardiac rehabilitation (CR) program', 'coronary artery bypass graft (CABG) surgery', '20 sessions of Phase 2 CR program combined with education and counselling', 'Cardiac Rehabilitation', 'Coronary Artery Bypass Graft Surgery']","['mean score of hope', 'mean score of hope between pre-intervention']","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",104.0,0.02397,There was no significant difference in the mean score of hope between the control and intervention groups before the intervention.,"[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Rakhshan', 'Affiliation': 'Nursing Department, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afsoon', 'Initials': 'A', 'LastName': 'Toufigh', 'Affiliation': 'Student Research Commitee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azimeh', 'Initials': 'A', 'LastName': 'Dehghani-Firouzabadi', 'Affiliation': 'Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Yektatalab', 'Affiliation': 'Nursing Department, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Risk management and healthcare policy,['10.2147/RMHP.S262656']
2334,32922107,Developing a Guided Imagery Telephone-Based Tobacco Cessation Program for a Randomized Controlled Trial.,"Background/Aims


Guided imagery is an evidence-based, multi-sensory, cognitive process that can be used to increase motivation and achieve a desired behavior. Quitlines are effective, standard care approaches for tobacco cessation; however, utilization of quitlines is low. Using guided imagery-based interventions for smoking cessation may appeal to smokers who do not utilize traditional quitline services. This paper reports the development of program materials for a randomized controlled feasibility trial of a guided imagery-based smoking cessation intervention. The objective of the formative work was to ensure that program materials are inclusive of groups that are less likely to use quitlines, including men and racial/ethnic minority tobacco users.
Methods


A three-phase process was used to complete formative assessment: (1) integration of evidence-based cessation practices into program development; (2) iterative small group interviews (N = 46) to modify the program; and (3) pilot-testing the coaching protocol and study process among a small sample of smokers (N = 5).
Results


The Community Advisory Board and project consultants offered input on program content and study recruitment based on their knowledge of minority communities with whom they conduct outreach. Small group interview participants included members of underserved quitline populations (52.37% non-white; 55.56% men). Only 28.26% of participants had prior experience with guided imagery, but others described the use of similar mindfulness and meditation practices. Participant feedback was incorporated into program materials and protocols.
Discussion


Iteratively collected feedback and pilot testing influenced program content and delivery and informed study processes for a randomized controlled feasibility trial of a telephone-delivered, guided imagery-based intervention.",2020,"Only 28.26% of participants had prior experience with guided imagery, but others described the use of similar mindfulness and meditation practices.","['men and racial/ethnic minority tobacco users', 'Small group interview participants included members of underserved quitline populations (52.37% non-white; 55.56% men']","['guided imagery-based interventions', 'Guided Imagery Telephone-Based Tobacco Cessation Program', 'complete formative assessment: (1) integration of evidence-based cessation practices into program development; (2) iterative small group interviews (N\u2009=\u200946) to modify the program; and (3) pilot-testing the coaching protocol', 'telephone-delivered, guided imagery-based intervention', 'guided imagery-based smoking cessation intervention']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033333', 'cui_str': 'Program development'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",[],,0.0420054,"Only 28.26% of participants had prior experience with guided imagery, but others described the use of similar mindfulness and meditation practices.","[{'ForeName': 'Julie S', 'Initials': 'JS', 'LastName': 'Armin', 'Affiliation': 'Department of Family & Community Medicine, The University of Arizona College of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family & Community Medicine, The University of Arizona College of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Giacobbi', 'Affiliation': 'College of Physical Activity and Sport Sciences and School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Povis', 'Affiliation': 'The University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment, Tucson AZ, USA.'}, {'ForeName': 'Yessenya', 'Initials': 'Y', 'LastName': 'Barraza', 'Affiliation': 'The University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment, Tucson AZ, USA.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Gordon', 'Affiliation': 'College of Nursing, The University of Arizona, Tucson, AZ, USA.'}]",Tobacco use insights,['10.1177/1179173X20949267']
2335,32922181,Sedation and Analgesia for Liver Cancer Percutaneous Radiofrequency Ablation: Fentanyl and Oxycodone Comparison.,"Background : Sedation and analgesia use in percutaneous radiofrequency ablation (RFPA) for liver cancer is a necessary part of the procedure; however, the optimal medicine for sedation and analgesia for PRFA remains controversial. The aim of this study was to compare the perioperative pain management, haemodynamic stability and side effects between oxycodone (OXY) and fentanyl (FEN) use in patients under dexmedetomidine sedation.  Methods:  Two hundred and five adults with an American Society of Anaesthesiologists physical status score of I to II were included in this study. Patients were assigned to the OXY (n=101) or FEN (n=104) group. Radiofrequency ablation was performed under spontaneous breathing and with painless anaesthesia administered intravenously. The outcomes included fluctuations in mean arterial pressure, heart rate, side effects and the perioperative numerical rating scale (NRS).  Results:  Radiofrequency ablation was successfully performed in 205 patients. No significant differences were observed in mean blood pressure fluctuations between the two groups despite the longer durations of ablation and total sedation time in the OXY group. The highest NRS score during the surgery and 1 hour and 2 hours after the surgery were significantly lower in the OXY group than in the FEN group. Heart rate fluctuations were significantly lower in the OXY group than in FEN group throughout the surgery. More patients in the FEN group displayed unwanted body movement and respiratory depression.  Conclusions:  Both oxycodone and fentanyl can be applied for liver cancer percutaneous radiofrequency ablation; however, oxycodone provides a better patient experience, lower postoperative pain, less respiratory depression and stable haemodynamic fluctuations.",2020,No significant differences were observed in mean blood pressure fluctuations between the two groups despite the longer durations of ablation and total sedation time in the OXY group.,"['205 patients', 'liver cancer percutaneous radiofrequency ablation', 'patients under dexmedetomidine sedation', 'Two hundred and five adults with an American Society of Anaesthesiologists physical status score of I to II were included in this study']","['percutaneous radiofrequency ablation (RFPA', 'Radiofrequency ablation', 'FEN', 'oxycodone (OXY) and fentanyl (FEN', 'oxycodone and fentanyl']","['mean blood pressure fluctuations', 'perioperative pain management, haemodynamic stability and side effects', 'unwanted body movement and respiratory depression', 'longer durations of ablation and total sedation time', 'Heart rate fluctuations', 'fluctuations in mean arterial pressure, heart rate, side effects and the perioperative numerical rating scale (NRS', 'highest NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",205.0,0.0258347,No significant differences were observed in mean blood pressure fluctuations between the two groups despite the longer durations of ablation and total sedation time in the OXY group.,"[{'ForeName': 'Jiangling', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Qicheng', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Zewu', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Kangjie', 'Initials': 'K', 'LastName': 'Xie', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Huidan', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Anaesthesiology, Cancer Hospital of the University of Chinese Academy and Sciences. Zhejiang, Hangzhou, 310022, China.'}]",International journal of medical sciences,['10.7150/ijms.47067']
2336,32922193,The efficacy of intramuscular ephedrine in preventing hemodynamic perturbations in patients with spinal anesthesia and dexmedetomidine sedation.,"Dexmedetomidine is used for sedation during spinal anesthesia. The sympatholytic effect of dexmedetomidine may exacerbate hypotension and bradycardia with spinal anesthesia. This study investigated the effects of prophylactic intramuscular injection of ephedrine in preventing hypotension and bradycardia occurring through combined use of spinal anesthesia and dexmedetomidine. One hundred sixteen patients scheduled for lower extremity orthopedic surgery were randomized into two groups receiving either ephedrine 20 mg intramuscularly or equivalent amount of 0.9% NaCl, both with dexmedetomidine and spinal anesthesia. The primary endpoint was the incidence of hemodynamic perturbations (hypotension or bradycardia event). The secondary endpoint was a rescue doses of ephedrine and atropine. The incidence of hemodynamic perturbations was significantly lower in the ephedrine group compared with to the saline group (26.3% versus 55.9%, p = 0.001). The rescue doses of atropine (0.09 ± 0.21 versus 0.28 ± 0.41, p = 0.001) and ephedrine (1.04 ± 2.89 versus 2.03 ± 3.25, p = 0.007) were also significantly lower in the ephedrine group. There was no differences in number of patients with hypertensive (7.0% versus 11.9%, p = 0.375) or tachycardia (1.8% versus 3.4% p = 0.581) episodes. The use of ephedrine intramuscular injections may be a safe and efficacious option in preventing hemodynamic perturbations in patients who received spinal anesthesia and sedation using dexmedetomidine.",2020,"The rescue doses of atropine (0.09 ± 0.21 versus 0.28 ± 0.41, p = 0.001) and ephedrine (1.04 ± 2.89 versus 2.03 ± 3.25, p = 0.007) were also significantly lower in the ephedrine group.","['sedation during spinal anesthesia', 'patients who received spinal anesthesia and sedation using', 'One hundred sixteen patients scheduled for lower extremity orthopedic surgery', 'patients with spinal anesthesia and dexmedetomidine sedation']","['ephedrine 20 mg intramuscularly or equivalent amount of 0.9% NaCl', 'ephedrine', 'ephedrine intramuscular injections', 'ephedrine and atropine', 'dexmedetomidine and spinal anesthesia', 'Dexmedetomidine', 'dexmedetomidine', 'intramuscular ephedrine', 'atropine']","['number of patients with hypertensive', 'tachycardia', 'incidence of hemodynamic perturbations', 'hemodynamic perturbations', 'incidence of hemodynamic perturbations (hypotension or bradycardia event', 'hypotension and bradycardia']","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",116.0,0.0402851,"The rescue doses of atropine (0.09 ± 0.21 versus 0.28 ± 0.41, p = 0.001) and ephedrine (1.04 ± 2.89 versus 2.03 ± 3.25, p = 0.007) were also significantly lower in the ephedrine group.","[{'ForeName': 'Ji-Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University Wonju College of Medicine, Wonju, Gangwon-do, Republic of Korea.'}, {'ForeName': 'Jae-Kwang', 'Initials': 'JK', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University Wonju College of Medicine, Wonju, Gangwon-do, Republic of Korea.'}, {'ForeName': 'Hyun Kyo', 'Initials': 'HK', 'LastName': 'Lim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University Wonju College of Medicine, Wonju, Gangwon-do, Republic of Korea.'}]",International journal of medical sciences,['10.7150/ijms.48772']
2337,32922254,Longitudinal Electroencephalography Analysis in Subacute Stroke Patients During Intervention of Brain-Computer Interface With Exoskeleton Feedback.,"Background


Brain-computer interface (BCI) has been regarded as a newly developing intervention in promoting motor recovery in stroke survivors. Several studies have been performed in chronic stroke to explore its clinical and subclinical efficacy. However, evidence in subacute stroke was poor, and the longitudinal sensorimotor rhythm changes in subacute stroke after BCI with exoskeleton feedback were still unclear.
Materials and Methods


Fourteen stroke patients in subacute stage were recruited and randomly allocated to BCI group ( n  = 7) and the control group ( n  = 7). Brain-computer interface training with exoskeleton feedback was applied in the BCI group three times a week for 4 weeks. The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) scale was used to assess motor function improvement. Brain-computer interface performance was calculated across the 12-time interventions. Sensorimotor rhythm changes were explored by event-related desynchronization (ERD) changes and topographies.
Results


After 1 month BCI intervention, both the BCI group ( p  = 0.032) and the control group ( p  = 0.048) improved in FMA-UE scores. The BCI group (12.77%) showed larger percentage of improvement than the control group (7.14%), and more patients obtained good motor recovery in the BCI group (57.1%) than did the control group (28.6%). Patients with good recovery showed relatively higher online BCI performance, which were greater than 70%. And they showed a continuous improvement in offline BCI performance and obtained a highest value in the last six sessions of interventions during BCI training. However, patients with poor recovery reached a platform in the first six sessions of interventions and did not improve any more or even showed a decrease. In sensorimotor rhythm, patients with good recovery showed an enhanced ERD along with time change. Topographies showed that the ipsilesional hemisphere presented stronger activations after BCI intervention.
Conclusion


Brain-computer interface training with exoskeleton feedback was feasible in subacute stroke patients. Brain-computer interface performance can be an index to evaluate the efficacy of BCI intervention. Patients who presented increasingly stronger or continuously strong activations (ERD) may obtain better motor recovery.",2020,"After 1 month BCI intervention, both the BCI group ( p  = 0.032) and the control group ( p  = 0.048) improved in FMA-UE scores.","['subacute stroke patients', 'Patients who presented increasingly stronger or continuously strong activations (ERD', 'Fourteen stroke patients in subacute stage', 'Subacute Stroke Patients']","['Conclusion\n\n\nBrain-computer interface training with exoskeleton feedback', '\n\n\nBrain-computer interface (BCI', 'BCI']","['enhanced ERD', 'Sensorimotor rhythm changes', 'Fugl-Meyer Assessment of Upper Extremity (FMA-UE) scale', 'offline BCI performance', 'good motor recovery', 'FMA-UE scores', 'online BCI performance']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.014603,"After 1 month BCI intervention, both the BCI group ( p  = 0.032) and the control group ( p  = 0.048) improved in FMA-UE scores.","[{'ForeName': 'Shugeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Computer Science and Technology, Shanghai Maritime University, Shanghai, China.'}, {'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': 'School of Mechanical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hewei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shui-Hua', 'Initials': 'SH', 'LastName': 'Wang', 'Affiliation': 'School of Architecture Building and Civil Engineering, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00809']
2338,32922306,"Changes in Perceived Exertion, Well-Being, and Recovery During Specific Judo Training: Impact of Training Period and Exercise Modality.","The present study investigated the effect of intense and tapering training periods using different exercise modalities (i.e., Randori - grip dispute practice without throwing technique, Uchi-komi - technique repetition training, and sprinting) on rating of perceived exertion (RPE), well-being indices, recovery state, and physical enjoyment in judo athletes. Sixty-one adolescent male and female judo athletes (age: 15 ± 1 years) were randomly assigned to one of three experimental or one control groups. Experimental groups (Randori, Uchi-komi, and running) trained four times per week for 4 weeks of intense training (in addition to their usual technical-tactical judo training; control group underwent only such a training) followed by 12 days of tapering. RPE, well-being indices [i.e., sleep, stress, fatigue, and delayed onset muscle soreness (DOMS)], total quality of recovery (TQR), and physical enjoyment were measured every session. RPE, sleep, stress, fatigue, DOMS, Hooper index (HI; sum of wellbeing indices), and TQR were lower in the tapering compared with the intensified training period ( P  < 0.001). Moreover, the running group showed better values for sleep ( P  < 0.001), stress ( P  < 0.001), fatigue ( P  = 0.006), DOMS ( P  < 0.001), and HI ( P  < 0.001) in comparison with the other training groups, indicating a more negative state of wellbeing. The Randori and Uchi-komi groups showed higher values for TQR and physical enjoyment (both  P  < 0.001) than the running group, whereas RPE was lower in the control compared with all training groups ( P  < 0.001). Coaches should use more specific training modalities (i.e., Randori and Uchi-komi) during intensified training and should monitor well-being indices, RPE, and TQR during training periods. Moreover, for all variables, 12 days tapering period are beneficial for improving wellbeing and recovery after 4 weeks of intense training.",2020,"The Randori and Uchi-komi groups showed higher values for TQR and physical enjoyment (both  P  < 0.001) than the running group, whereas RPE was lower in the control compared with all training groups ( P  < 0.001).","['judo athletes', 'Sixty-one adolescent male and female judo athletes (age: 15 ± 1 years']","['intense training (in addition to their usual technical-tactical judo training; control group underwent only such a training', 'intense and tapering training periods using different exercise modalities (i.e., Randori - grip dispute practice without throwing technique, Uchi-komi - technique repetition training, and sprinting']","['values for sleep', 'negative state of wellbeing', 'RPE, sleep, stress, fatigue, DOMS, Hooper index (HI; sum of wellbeing indices), and TQR', 'rating of perceived exertion (RPE), well-being indices, recovery state, and physical enjoyment', 'DOMS', 'RPE, well-being indices [i.e., sleep, stress, fatigue, and delayed onset muscle soreness (DOMS)], total quality of recovery (TQR), and physical enjoyment', 'fatigue', 'Perceived Exertion, Well-Being, and Recovery', 'RPE', 'TQR and physical enjoyment']","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0680226', 'cui_str': 'Argumentative behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0574690', 'cui_str': 'Komi language'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",61.0,0.0197203,"The Randori and Uchi-komi groups showed higher values for TQR and physical enjoyment (both  P  < 0.001) than the running group, whereas RPE was lower in the control compared with all training groups ( P  < 0.001).","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Ouergui', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, El Kef, Tunisia.'}, {'ForeName': 'Luca Paolo', 'Initials': 'LP', 'LastName': 'Ardigò', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, School of Exercise and Sport Science, University of Verona, Verona, Italy.'}, {'ForeName': 'Okba', 'Initials': 'O', 'LastName': 'Selmi', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, El Kef, Tunisia.'}, {'ForeName': 'Danielle Evé', 'Initials': 'DE', 'LastName': 'Levitt', 'Affiliation': 'Applied Physiology Laboratory, University of North Texas, Denton, TX, United States.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': ""Institut Supérieur du Sport et de l'Education Physique de Sfax, Université de Sfax, Sfax, Tunisia.""}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Bouassida', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, El Kef, Tunisia.'}, {'ForeName': 'Ezdine', 'Initials': 'E', 'LastName': 'Bouhlel', 'Affiliation': 'Laboratory of Cardio-Circulatory, Respiratory, Metabolic and Hormonal Adaptations to Muscular Exercise, Faculty of Medicine Ibn El Jazzar, University of Sousse, Sousse, Tunisia.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'Martial Arts and Combat Sports Research Group, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}]",Frontiers in physiology,['10.3389/fphys.2020.00931']
2339,32922328,Emotional and Cognitive Responses to Theatrical Representations of Aggressive Behavior.,"Representation of human conflict is central to theater performance. In our study, we have used self-reported measures of emotional experience and a word recall task, in order to assess the effects of theatrical representations of violence. Forty participants were randomly assigned to the role of performer or spectator, in either a realistic representation of a script or in a version that recollected the same actions of the script in a series of intertwined monologs. The script represented an aggressive interaction between two work colleagues. Our results show both statistically significant differences in the levels of depression and positive emotions reported after enacting the script, as well as differences in the performance on the word recall task containing aggressive related and non-related stimuli. The results point to stronger effects for performing theatrical representations of violent actions, as compared to recollecting or watching such actions. The fact that actors experienced higher positive emotions is in line with the two-pedal model of aggressive behavior. This model suggests that negative emotions toward aggressive behavior might change to positive emotions due to the repetition in performing violent behaviors, as a key for the transition from reactive aggression to appetitive aggression. Other implications for the study of aggression in theatrical representations are discussed.",2020,"Forty participants were randomly assigned to the role of performer or spectator, in either a realistic representation of a script or in a version that recollected the same actions of the script in a series of intertwined monologs.",['Forty participants'],[],"['Emotional and Cognitive Responses', 'positive emotions', 'levels of depression and positive emotions']",[],[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",40.0,0.0251221,"Forty participants were randomly assigned to the role of performer or spectator, in either a realistic representation of a script or in a version that recollected the same actions of the script in a series of intertwined monologs.","[{'ForeName': 'Alexandru I', 'Initials': 'AI', 'LastName': 'Berceanu', 'Affiliation': 'Laboratory for Cognitive Development and Applied Psychology through Immersive Experiences, CINETic Centre, National University of Theatre and Film ""Ion Luca Caragiale"", Bucharest, Romania.'}, {'ForeName': 'Silviu', 'Initials': 'S', 'LastName': 'Matu', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babeş-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Bianca I', 'Initials': 'BI', 'LastName': 'Macavei', 'Affiliation': 'Department of Psychology, Babeş-Bolyai University, Cluj-Napoca, Romania.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01785']
2340,32922345,Causal Mediation Analysis in the Presence of Post-treatment Confounding Variables: A Monte Carlo Simulation Study.,"In many disciplines, mediating processes are usually investigated with randomized experiments and linear regression to determine if the treatment affects the outcome through a mediator. However, randomizing the treatment will not yield accurate causal direct and indirect estimates unless certain assumptions are satisfied since the mediator status is not randomized. This study describes methods to estimate causal direct and indirect effects and reports the results of a large Monte Carlo simulation study on the performance of the ordinary regression and modern causal mediation analysis methods, including a previously untested doubly robust sequential g-estimation method, when there are confounders of the mediator-to-outcome relation. Results show that failing to measure and incorporate potential post-treatment confounders in a mediation model leads to biased estimates, regardless of the analysis method used. Results emphasize the importance of measuring potential confounding variables and conducting sensitivity analysis.",2020,"However, randomizing the treatment will not yield accurate causal direct and indirect estimates unless certain assumptions are satisfied since the mediator status is not randomized.",[],[],[],[],[],[],,0.0349496,"However, randomizing the treatment will not yield accurate causal direct and indirect estimates unless certain assumptions are satisfied since the mediator status is not randomized.","[{'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Kisbu-Sakarya', 'Affiliation': 'Department of Psychology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'MacKinnon', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Valente', 'Affiliation': 'Center for Children and Families, Department of Psychology, Florida International University, Miami, FL, United States.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Çetinkaya', 'Affiliation': 'Department of Psychology, Koç University, Istanbul, Turkey.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02067']
2341,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND


Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD


A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS


PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
2342,32919170,Is Moulage effective in improving clinical skills of nursing students for the assessment of pressure injury?,"BACKGROUND


In wound care simulations, the practice can be performed on 3D-wounds formed by moulage. Moulage helps the student to perceive the etiology, physiology, and healing processes of the wound, and it can also be used to improve the students' wound assessment skills.
OBJECTIVE


The aim of this study is to investigate the effectiveness of moulage in the improvement of pressure injury assessment skills of nursing students.
DESIGN


A quasi-experimental study.
SETTINGS


A nursing faculty at a public university.
PARTICIPANTS


All fourth-year students (n = 73) who take the simulation elective course were invited to participate.
METHODS


Fall semester students (n = 38) constituted the control group and spring semester students (n = 35) formed the intervention group. The coin-flipping method was used to match the education period and student groups. The intervention group simulation was performed using moulage, and the control group simulation was performed using a pressure ulcer visuals. The same simulation scenarios were used for both groups. The data were collected using the Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers.
RESULTS


Students' knowledge scores for pressure injury assessment have improved significantly in both the intervention group (pre-test:61.71 ± 9.77 and post-test 70.57 ± 12.53, t = -4.27, p < 0.001) and the control group (pre-test: 66.81 ± 13.47 and post-test 73.06 ± 15.50, t = -2.34, p = 0.02). Laboratory and clinical pressure injury assessment skill scores of the intervention group students were significantly higher than the control group. Besides, the correct staging percentages of the intervention group students are higher than the control group students during the clinical practice (χ2 = 5.05, p = 0.02).
CONCLUSIONS


It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.",2020,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"['All fourth-year students (n\xa0=\xa073) who take the simulation elective course were invited to participate', 'Fall semester students (n\xa0=\xa038) constituted the control group and spring semester students (n\xa0=\xa035) formed the intervention group', 'nursing students']",[],"['Laboratory and clinical pressure injury assessment skill scores', 'knowledge scores for pressure injury assessment', 'Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]",[],"[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",73.0,0.0183299,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Sezgunsay', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Training and Research Hospital, Stoma and Wound Care Center, Ankara.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Ankara. Electronic address: tulay.basak@sbu.edu.tr.'}]",Nurse education today,['10.1016/j.nedt.2020.104572']
2343,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
2344,32919280,No benefit of HDL mimetic CER-001 on carotid atherosclerosis in patients with genetically determined very low HDL levels.,"BACKGROUND AND AIMS


Infusion of high-density lipoprotein (HDL) mimetics failed to induce regression of atherosclerosis in recent randomized clinical trials. However, patients in these previous trials had normal levels of HDL-cholesterol, which potentially limited efficacy. Patients with very low levels of HDL-cholesterol and impaired cholesterol efflux capacity can be expected to derive the most potential benefit from infusion of HDL mimetics. This randomized clinical trial evaluated the efficacy of infusions of the HDL mimetic CER-001 in patients with genetically determined very low levels of HDL cholesterol.
METHODS


In this multicenter, randomized clinical trial, we recruited patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants). Participants were randomized to intravenous infusions of 8 mg/kg CER-001 or placebo (2:1 ratio), comprising 9 weekly infusions followed by infusions every two weeks. Patients underwent repeated 3T-MRI to assess mean vessel wall area and  18 F-FDG PET/CT to quantify arterial wall inflammation.
RESULTS


A total of 30 patients with a mean age of 52.7 ± 7.4 years and HDL-cholesterol of 0.35 ± 0.25 mmol/L were recruited. After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21). Furthermore, there was no significant difference in carotid arterial wall inflammation (n = 24, treatment difference: 0.10 target-to-background ratio of the most diseased segment, p = 0.33) after 24 weeks.
CONCLUSION


In patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with HDL mimetic CER-001 did not reduce carotid vessel wall dimensions or arterial wall inflammation, compared with placebo.",2020,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","['patients with genetically determined very low HDL levels', 'patients with genetically determined very low levels of HDL cholesterol', '30 patients with a mean age of 52.7\xa0±\xa07.4 years and HDL-cholesterol of 0.35\xa0±\xa00.25\xa0mmol/L were recruited', 'patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with', 'patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants']","['placebo', 'HDL mimetic CER-001', 'intravenous infusions of 8\xa0mg/kg CER-001 or placebo', 'repeated 3T-MRI']","['carotid arterial wall inflammation', 'absolute change in mean vessel wall area', 'normal levels of HDL-cholesterol', 'carotid atherosclerosis', 'carotid vessel wall dimensions or arterial wall inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704429', 'cui_str': 'Familial hypoalphalipoproteinemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C3884609', 'cui_str': 'CER-001'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.409435,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","[{'ForeName': 'Kang H', 'Initials': 'KH', 'LastName': 'Zheng', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Kaiser', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Casper C', 'Initials': 'CC', 'LastName': 'van Olden', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of Sao Paulo Medical School Hospital, Sao Paulo, Brazil; Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Dasseux', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Genest', 'Affiliation': 'Department of Medicine, Division of Cardiology, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Department of Medicine, Université de Montréal, Chicoutimi, Quebec, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, Utrecht University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Keyserling', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Hein J', 'Initials': 'HJ', 'LastName': 'Verberne', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Leitersdorf', 'Affiliation': 'Center for Research, Prevention and Treatment of Atherosclerosis, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olivier S', 'Initials': 'OS', 'LastName': 'Descamps', 'Affiliation': 'Centres Hospitaliers Jolimont, La Louvière, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands. Electronic address: e.s.stroes@amsterdamumc.nl.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.004']
2345,32920647,A Delta-Opioid Receptor Gene Polymorphism Moderates the Therapeutic Response to Extended-Release Buprenorphine in Opioid Use Disorder.,"BACKGROUND


Buprenorphine treatment is not equally effective in all patients with opioid use disorder (OUD). Two retrospective studies showed that, among African Americans (AAs), rs678849, a polymorphism in the delta-opioid receptor gene, moderated the therapeutic effect of sublingual buprenorphine.
METHODS


We examined the rs678849 as a moderator of the response to an extended-release subcutaneous buprenorphine formulation (BUP-XR) in a 24-week OUD treatment study of 127 AAs and 327 European Americans (EAs). Participants were randomly assigned to receive: 1) BUP-XR as 2 monthly injections of 300 mg followed by either 300 mg monthly or 100 mg monthly for four months or 2) monthly volume-matched placebo injections. GEE logistic regression analyses tested, per population group, the main and interaction effects of treatment (BUP-XR vs. placebo) and genotype group (rs678849*CC vs. CT/TT) on weekly urine drug screens (UDS).
RESULTS


Among AAs, the placebo group had higher rates of opioid-positive UDS than the BUP-XR group [log odds ratio (LOR)=1.67, 95% CI = 0.36, 2.98], but no genotype by treatment effect (p=0.80). Among EAs, the placebo group also showed higher rates of opioid-positive UDS than the BUP-XR group (LOR=1.97, 95% CI = 1.14, 2.79), but a significant genotype by treatment interaction [X2(1)=4.33, p=0.04].
CONCLUSION


We found a moderating effect of rs678849 on the response to buprenorphine treatment of OUD in EAs, but not AAs. These findings require replication in well powered, prospective studies of both AA and EA OUD patients treated with BUP-XR and stratified on rs678849 genotype.",2020,"We found a moderating effect of rs678849 on the response to buprenorphine treatment of OUD in EAs, but not AAs.","['patients with opioid use disorder (OUD', '127 AAs and 327 European Americans (EAs']","['Buprenorphine', 'BUP-XR as 2 monthly injections of 300\xa0mg followed by either 300\xa0mg monthly or 100\xa0mg monthly for four months or 2) monthly volume-matched placebo injections', 'buprenorphine', 'placebo', 'buprenorphine formulation (BUP-XR']",['rates of opioid-positive UDS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0239307', 'cui_str': 'European'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0798136,"We found a moderating effect of rs678849 on the response to buprenorphine treatment of OUD in EAs, but not AAs.","[{'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Center for Studies of Addiction, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Center for Studies of Addiction, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Crist', 'Affiliation': 'Mental Illness Research, Education and Clinical Center of the Veterans Integrated Service Network 4, Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hartwell', 'Affiliation': 'Center for Studies of Addiction, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Le Moigne', 'Affiliation': 'Indivior Inc., North Chesterfield, Virginia, USA.'}, {'ForeName': 'Celine M', 'Initials': 'CM', 'LastName': 'Laffont', 'Affiliation': 'Indivior Inc., North Chesterfield, Virginia, USA.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Andorn', 'Affiliation': 'Indivior Inc., North Chesterfield, Virginia, USA.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa069']
2346,32920677,Predictors for quality of life improvement after acute osteoporotic vertebral fracture: results of post hoc analysis of a prospective randomized study.,"PURPOSE


No study has investigated the clinical and radiographic risk factors for the deterioration of quality of life (QOL) beyond 6 months after osteoporotic vertebral fractures (OVF). The purpose of this study was to identify the predictors associated with poor QOL improvement after OVF.
METHODS


This post hoc analysis included 166 women aged 65-85 years with acute 1-level OVFs. For the patient-reported outcome measures, scores on the European Quality of Life-5 Dimensions (EQ-5D) scale, and visual analogue scale (VAS) for low back pain were used. Lateral radiography at 0, 12, and 48 weeks and magnetic resonance imaging (MRI) at enrollment and at 48 weeks were performed. The associations between baseline variables with change scores for EQ-5D were investigated using a multiple linear regression model.
RESULTS


Univariate analysis showed that time since fracture, EQ-5D score, and VAS for low back pain at 0 week showed significant association with increased EQ-5D score from 0 to 48 weeks. According to the multiple regression analysis, the following equation was obtained: increased EQ-5D score from 0 to 48 weeks = 1.305 - 0.978 × EQ-5D at 0 week - 0.021 × VAS for low back pain at 0 week - 0.006 × age + (fluid-intensity T2-weighted MR image patterns: - 0.037, except for fluid-intensity T2-weighted MR image patterns: + 0.037).
CONCLUSION


In conclusion, older patients with severe low back pain and fluid-intensity T2-weighted MR image patterns were more likely to have lower QOL improvements after OVFs and may therefore need extra support to improve QOL.",2020,"According to the multiple regression analysis, the following equation was obtained: increased EQ-5D score from 0 to 48 weeks = 1.305 - 0.978 × EQ-5D at 0 week - 0.021 × VAS for low back pain at 0 week - 0.006 ","['acute osteoporotic vertebral fracture', 'older patients with severe low back pain', '166 women aged 65-85\xa0years with acute 1-level OVFs']",[],"['time since fracture, EQ-5D score, and VAS for low back pain', 'European Quality of Life-5 Dimensions (EQ-5D) scale, and visual analogue scale (VAS) for low back pain', 'quality of life (QOL', 'EQ-5D score', 'quality of life improvement']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",166.0,0.129699,"According to the multiple regression analysis, the following equation was obtained: increased EQ-5D score from 0 to 48 weeks = 1.305 - 0.978 × EQ-5D at 0 week - 0.021 × VAS for low back pain at 0 week - 0.006 ","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Inose', 'Affiliation': 'Department of Orthopaedics, Graduate School, Tokyo Medical and Dental University, Tokyo, 108-0075, Japan. inose.orth@tmd.ac.jp.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Orthopaedics, Graduate School, Tokyo Medical and Dental University, Tokyo, 108-0075, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Department of Orthopedic Surgery, Graduate School of Medicine, Osaka City University, Osaka, 545-8585, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Department of Orthopedic Surgery, Graduate School of Medicine, Osaka City University, Osaka, 545-8585, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Togawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University of Medicine, Shizuoka, 431-3192, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Hirano', 'Affiliation': 'Department of Orthopedic Surgery, Niigata University Medical and Dental Hospital, Niigata, 951-8520, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Tokuhashi', 'Affiliation': 'Department of Orthopaedic Surgery, Nihon University, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi, Yamanashi, 409-3898, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi, Yamanashi, 409-3898, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Department of Orthopaedic Surgery, Kitasato University Kitasato Institute Hospital, Tokyo, 108-8642, Japan.'}, {'ForeName': 'Kimiaki', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Orthopaedic Surgery, Kurume University School of Medicine, Kurume University, Fukuoka, 830-0011, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Sasao', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School, School of Medicine, St. Marianna University, Kanagawa, 216-8511, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Takahata', 'Affiliation': 'Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine, Hokkaido, 060-8638, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Otani', 'Affiliation': 'Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, 960-1295, Japan.'}, {'ForeName': 'Suketaka', 'Initials': 'S', 'LastName': 'Momoshima', 'Affiliation': 'Department of Diagnostic Radiology, Center for Preventive Medicine, Keio University School of Medicine, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Biostatistics, M&D Data Science Center, Tokyo Medical and Dental University, Tokyo, 108-0075, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yuasa', 'Affiliation': 'Department of Orthopaedics, Graduate School, Tokyo Medical and Dental University, Tokyo, 108-0075, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hirai', 'Affiliation': 'Department of Orthopaedics, Graduate School, Tokyo Medical and Dental University, Tokyo, 108-0075, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yoshii', 'Affiliation': 'Department of Orthopaedics, Graduate School, Tokyo Medical and Dental University, Tokyo, 108-0075, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Okawa', 'Affiliation': 'Department of Orthopaedics, Graduate School, Tokyo Medical and Dental University, Tokyo, 108-0075, Japan.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02629-9']
2347,32920700,The effect of compliance with a perioperative goal-directed therapy protocol on outcomes after high-risk surgery: a before-after study.,"Perioperative goal-directed therapy is considered to improve patient outcomes after high-risk surgery. The association of compliance with perioperative goal-directed therapy protocols and postoperative outcomes is unclear. The purpose of this study is to determine the effect of protocol compliance on postoperative outcomes following high-risk surgery, after implementation of a perioperative goal-directed therapy protocol. Through a before-after study design, patients undergoing elective high-risk surgery before (before-group) and after implementation of a perioperative goal-directed therapy protocol (after-group) were included. Perioperative goal-directed therapy in the after-group consisted of optimized stroke volume variation or stroke volume index and optimized cardiac index. Additionally, the association of protocol compliance with postoperative complications when using perioperative goal-directed therapy was assessed. High protocol compliance was defined as ≥ 85% of the procedure time spent within the individual targets. The difference in complications during the first 30 postoperative days before and after implementation of the protocol was assessed. In the before-group, 214 patients were included and 193 patients in the after-group. The number of complications was higher in the before-group compared to the after-group (n = 414 vs. 282; p = 0.031). In the after-group, patients with high protocol compliance for stroke volume variation or stroke volume index had less complications compared to patients with low protocol compliance for stroke volume variation or stroke volume index (n = 187 vs. 90; p = 0.01). Protocol compliance by the attending clinicians is essential and should be monitored to facilitate an improvement in postoperative outcomes desired by the implementation of perioperative goal-directed therapy protocols.",2020,"In the after-group, patients with high protocol compliance for stroke volume variation or stroke volume index had less complications compared to patients with low protocol compliance for stroke volume variation or stroke volume index (n = 187 vs. 90; p = 0.01).","['214 patients were included and 193 patients in the after-group', 'patients undergoing elective high-risk surgery before (before-group) and after implementation of a perioperative goal-directed therapy protocol (after-group) were included']",[],"['complications', 'number of complications', 'stroke volume variation or stroke volume index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],"[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",214.0,0.051181,"In the after-group, patients with high protocol compliance for stroke volume variation or stroke volume index had less complications compared to patients with low protocol compliance for stroke volume variation or stroke volume index (n = 187 vs. 90; p = 0.01).","[{'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Boekel', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, PO Box 30.001, 9700RB, Groningen, The Netherlands.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Venema', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, PO Box 30.001, 9700RB, Groningen, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, PO Box 30.001, 9700RB, Groningen, The Netherlands.'}, {'ForeName': 'I C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'Chair of Department of Intensive Care, Maastricht University Medical Center+, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Vos', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, PO Box 30.001, 9700RB, Groningen, The Netherlands. j.j.vos@umcg.nl.'}, {'ForeName': 'T W L', 'Initials': 'TWL', 'LastName': 'Scheeren', 'Affiliation': 'Department of Anesthesiology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, PO Box 30.001, 9700RB, Groningen, The Netherlands.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00585-w']
2348,32920732,The efficacy and safety of pertuzumab plus trastuzumab and docetaxel as a first-line therapy in Japanese patients with inoperable or recurrent HER2-positive breast cancer: the COMACHI study.,"PURPOSE


In the CLEOPATRA study of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer, the Japanese patient subgroup did not demonstrate the improved progression-free survival (PFS) of pertuzumab plus trastuzumab and docetaxel vs. placebo that was seen in the overall population. Therefore, COMACHI was conducted to confirm the efficacy and safety of this treatment regimen in this patient subgroup.
METHODS


This was a phase IV study of pertuzumab plus trastuzumab and docetaxel in Japanese patients with histologically/cytologically confirmed inoperable or recurrent HER2-positive breast cancer. All patients received pertuzumab, trastuzumab, and docetaxel intravenously every 3 weeks until disease progression/unacceptable toxicity. The primary endpoint was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR). Safety was also assessed.
RESULTS


At final analysis, median investigator-assessed PFS was 22.8 months (95% CI 16.9-37.5). From first dose, OS rate at 1 year was 97.7%; and at 2 and 3 years were 88.5% and 79.1%, respectively. Of the 118 patients with measurable disease at baseline, response rate was 83.9% (95% CI 77.3-90.5) and median investigator-assessed DoR was 26.3 months (95% CI 17.1-not evaluable). Treatment was well tolerated, with no new safety signals detected.
CONCLUSIONS


Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.",2020,"Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.","['Japanese patients with inoperable or recurrent HER2-positive breast cancer', 'Japanese patients', 'Japanese patients with histologically/cytologically confirmed inoperable or recurrent HER2-positive breast cancer', 'patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer, the Japanese patient subgroup']","['pertuzumab, trastuzumab, and docetaxel', 'docetaxel vs. placebo', 'pertuzumab plus trastuzumab and docetaxel']","['Safety', 'median investigator-assessed DoR', 'efficacy and safety', 'investigator-assessed PFS', 'overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR', 'response rate', 'median investigator-assessed PFS', 'OS rate', 'progression-free survival (PFS']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",118.0,0.0535325,"Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.","[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Ohtani', 'Affiliation': 'Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Shigenori E', 'Initials': 'SE', 'LastName': 'Nagai', 'Affiliation': 'Breast Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Seiki', 'Initials': 'S', 'LastName': 'Takashima', 'Affiliation': 'Breast Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Breast Surgery, JCHO Kurume General Hospital, 21 Kushihara-machi Kurume, Fukuoka, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Tsuneizumi', 'Affiliation': 'Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Komoike', 'Affiliation': 'Surgery, Kindai University Hospital, Osakasayama, Japan.'}, {'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Osako', 'Affiliation': 'Breast Center, Kumamoto Shinto General Hospital, Kumamoto, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Breast Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Breast and Thyroid Surgery, Fukuyama City Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Surgery, Iwate Medical University, 2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture, 028-3695, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Breast and Endocrine Surgery, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abeno-ku, Osaka, 5458585, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Asakawa', 'Affiliation': 'Clinical Information and Intelligence Department, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Clinical Study Management Department, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shimizu', 'Affiliation': 'Clinical Science and Strategy Department, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan. nmasuda@alpha.ocn.ne.jp.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05921-x']
2349,32920767,Randomized Clinical Trial on Reduction of Radiotherapy Dose to the Elective Neck in Head and Neck Squamous Cell Carcinoma: Results on the Quality of Life.,"PURPOSE


A randomized trial was initiated to investigate whether a reduction of the dose to the elective nodal sites would result in less toxicity and improvement in Quality of Life (QoL) without compromising tumor control. This paper aimed to compare QoL in both treatment arms.
METHODS


Two-hundred head and neck cancer patients treated with radiotherapy (RT) or chemo-RT were randomized (all stages, mean age: 60 years, M/F: 82%/18%). The elective nodal volumes of patients randomized in the experimental arm were treated up to a 40 Gy equivalent dose. In the standard arm, the elective nodal volumes were treated up to a 50 Gy equivalent dose. The QoL data were collected using The European Organization for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and the EORTC Head and Neck Cancer module (H&N35).
RESULTS


A trend toward less decline in QoL during treatment was observed in the 40 Gy arm compared to the 50 Gy arm. Statistically significant differences for global health status, physical functioning, emotional functioning, speech problems, and trouble with social eating in favor of the 40 Gy arm were observed. A clinically relevant better outcome in the 40 Gy arm was found for physical functioning at the end of therapy.
CONCLUSION


QoL during RT for head and neck cancer tends to be less impaired in the 40 Gy arm. However, reducing the dose only on the elective neck does not result in clinically relevant improvement of QoL. Therefore, additional treatment strategies must be examined to further improve the QoL of HNSCC patients.",2020,"Statistically significant differences for global health status, physical functioning, emotional functioning, speech problems, and trouble with social eating in favor of the 40 Gy arm were observed.","['Two-hundred head and neck cancer patients treated with', 'Head and Neck Squamous Cell Carcinoma']","['radiotherapy (RT) or chemo-RT', 'Radiotherapy']","['global health status, physical functioning, emotional functioning, speech problems, and trouble with social eating', 'toxicity and improvement in Quality of Life (QoL', 'QoL', 'physical functioning', 'elective nodal volumes']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0395016', 'cui_str': 'Speech problem'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",200.0,0.0687993,"Statistically significant differences for global health status, physical functioning, emotional functioning, speech problems, and trouble with social eating in favor of the 40 Gy arm were observed.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Deschuymer', 'Affiliation': 'Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nevens', 'Affiliation': 'Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Duprez', 'Affiliation': 'Department of Radiotherapy-Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Daisne', 'Affiliation': 'Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voordeckers', 'Affiliation': 'Department of Radiation Oncology, UZ Brussel, Vrije Universiteit Brussel, Brussel, Belgium.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'De Neve', 'Affiliation': 'Department of Radiotherapy-Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nuyts', 'Affiliation': 'Department of Radiation Oncology, KU Leuven - University of Leuven, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. sandra.nuyts@uzleuven.be.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02628-w']
2350,32920777,"Correction to: Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.","The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.",2020,"The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.",['Patients with Multiple Myeloma'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]",[],[],,0.0225663,"The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.","[{'ForeName': 'Asim V', 'Initials': 'AV', 'LastName': 'Farooq', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA. afarooq@bsd.uchicago.edu.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Degli Esposti', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Praneetha', 'Initials': 'P', 'LastName': 'Thulasi', 'Affiliation': 'Emory Eye Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Zaugg', 'Affiliation': 'Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ashraf Z', 'Initials': 'AZ', 'LastName': 'Badros', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bennie H', 'Initials': 'BH', 'LastName': 'Jeng', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Opalinska', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'January', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Colby', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00289-z']
2351,32920787,Understanding the mechanisms of placebo and nocebo effects.,"Although placebos have long been considered a nuisance in clinical research, over recent years they have become an active and productive field of research. Indeed, the placebo effect represents an elegant model to understand how the brain works. It is worth knowing that there is not a single but many placebo effects, with different mechanisms across different systems, medical conditions and therapeutic interventions. For example, brain mechanisms of expectation, anxiety and reward are all involved, as well as a variety of learning phenomena. There is also some experimental evidence of different genetic variants in placebo responsiveness. Pain and Parkinson&rsquo;s disease represent the most productive models to better understand the neurobiology of the placebo effect. In these medical conditions the neural networks involved have indeed been identified: that is, opioid, cannabinoid, cholecystokinin, cyclooxygenase, and dopamine modulatory networks in pain; and part of the basal ganglia circuitry in Parkinson&rsquo;s disease. Overall, there is today compelling evidence that placebos and drugs share common biochemical pathways and activate the same receptor pathways, which suggests possible interference between social stimuli and therapeutic rituals on one hand and pharmacological agents on the other. The same holds true for the nocebo effect, the opposite phenomenon of placebo. The assessment of patients&rsquo; expectations should become the rule in clinical trials in order to allow us a better interpretation of therapeutic outcomes when comparing placebo and active treatment groups. Administering drugs covertly is another way to identify the placebo psychobiological component without the administration of any placebo, and this provides important information on the role of patient&rsquo;s expectations in the therapeutic outcome. A further in-depth analysis of placebo and nocebo phenomena will certainly provide important information in the near future for a better understanding of human biology, medicine and society.",2020,"The same holds true for the nocebo effect, the opposite phenomenon of placebo.",[],"['placebo', 'placebos']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.1892,"The same holds true for the nocebo effect, the opposite phenomenon of placebo.","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Frisaldi', 'Affiliation': 'University of Turin Medical School, Neuroscience Department, Turin, Italy.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Shaibani', 'Affiliation': 'Nerve and Muscle Center of Texas, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'University of Turin Medical School, Neuroscience Department, Turin, Italy / Medicine and Physiology of Hypoxia, Plateau Rosà, Switzerland.'}]",Swiss medical weekly,['10.4414/smw.2020.20340']
2352,32920792,Value of the TTM risk score for early prognostication of comatose patients after out-of-hospital cardiac arrest in a Swiss university hospital.,"Comatose patients admitted to the intensive care unit (ICU) after out-of-hospital cardiac arrest frequently die after withdrawal of life support. Guidelines recommend scheduling prognostication no sooner than 96 hours after cardiac arrest, and strict withdrawal criteria leave many patients waiting for improvement for days without ever reaching a favourable outcome. In clinical practice, physicians are frequently confronted with vague living wills expressed by next of kin or an imprecise advance care directive soon after cardiac arrest. Often a decision to admit a patient to an ICU or limiting ICU treatment in terms of time or intensity is made early, based on the patient&rsquo;s preferences. The Target Temperature Management (TTM) risk score is an imperfect measure that predicts outcome early, at the time of ICU admission. It was developed on a data set of 939 patients included in the TTM Trial, a study in which unconscious patients after cardiac arrest were randomised into two temperature management arms. Patient selection in that trial might impede generalisability. We aimed to validate the TTM risk score with 100 consecutive patients treated in our ICU. Although we had different survival rates, reflecting a different patient population, we were able to confirm the score&rsquo;s albeit imperfect ability to predict outcome early after cardiac arrest. The suggested cut-off values of 10 and 16 can be used as a basis for discussion with the family; in particular, a risk score value below 10 predicts a favourable outcome and might guide early discussion. As in the original study, the outcome of an individual patient cannot be predicted. (ClinicalTrials.gov Identifier: NCT02722460).",2020,"The Target Temperature Management (TTM) risk score is an imperfect measure that predicts outcome early, at the time of ICU admission.","['939 patients included in the TTM Trial, a study in which unconscious patients after cardiac arrest', 'Comatose patients admitted to the intensive care unit (ICU) after out-of-hospital cardiac arrest frequently die after withdrawal of life support', '100 consecutive patients treated in our ICU', 'comatose patients after out-of-hospital cardiac arrest in a Swiss university hospital']",[],"['survival rates', 'Target Temperature Management (TTM) risk score', 'TTM risk score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1963783', 'cui_str': 'Withdrawal of life support'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035649', 'cui_str': 'Risk management'}]",,0.0311344,"The Target Temperature Management (TTM) risk score is an imperfect measure that predicts outcome early, at the time of ICU admission.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kägi', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Weck', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland / Department of Intensive Care Medicine, Hospital Region Biel/Bienne, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Iten', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Levis', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland / Department of Anaesthesiology and Pain Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Haenggi', 'Affiliation': 'Department of Intensive Care Medicine, Bern University Hospital, Inselspital, University of Bern, Switzerland.'}]",Swiss medical weekly,['10.4414/smw.2020.20344']
2353,32920802,Cooling During Exercise May Induce Benefits Linked to Improved Brain Perfusion.,"The aim of this study was to evaluate the impact of using a cooling vest during physical exercise (per-cooling) in humid and temperate conditions (≈22°C, ≈80% relative humidity) on perceptual and physiological responses (tissue oxygenation and heart rate). 20 physically active men performed twice a 30-min cycling exercise at 70% of their theoretical maximum heart rate while using an activated (experimental condition) and a deactivated (control condition) cooling system in a randomized crossover study. Heart rate and tissue (cerebral and muscular) oxygenation were continuously measured during exercise and recovery, and skin temperature was measured every 10 min. Perception of temperature, humidity and comfort were assessed at the end of the recovery period. Results showed a decrease in trunk skin temperature (p<0.05), a faster heart rate recovery and an increase in the concentration of total hemoglobin at the brain level (p<0.05) compared with control condition. Moreover, an improved subjective rating of thermal sensations, wetness and comfort compared to control values (p<0.05) was noted. In conclusion, wearing a cooling vest during submaximal exercise improves perceptual and physiological responses in humid temperate conditions, which may be due to a better blood perfusion at the brain level and a better parasympathetic reactivation.",2020,"Moreover, an improved subjective rating of thermal sensations, wetness and comfort compared to control values (p<0.05) was noted.",['20 physically active men'],"['cooling vest during physical exercise (per-cooling', '30-min cycling exercise at 70% of their theoretical maximum heart rate while using an activated (experimental condition) and a deactivated (control condition) cooling system']","['Heart rate and tissue (cerebral and muscular) oxygenation', 'concentration of total hemoglobin', 'trunk skin temperature', 'subjective rating of thermal sensations, wetness and comfort', 'perceptual and physiological responses (tissue oxygenation and heart rate', 'exercise and recovery, and skin temperature', 'Perception of temperature, humidity and comfort', 'heart rate recovery']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0205031', 'cui_str': 'Skin structure of trunk'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}]",20.0,0.0570131,"Moreover, an improved subjective rating of thermal sensations, wetness and comfort compared to control values (p<0.05) was noted.","[{'ForeName': 'Wafa', 'Initials': 'W', 'LastName': 'Douzi', 'Affiliation': 'Laboratoire ""Mobilité, Vieillissement, Exercice (MOVE) - EA 6314"" et Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dugué', 'Affiliation': 'Laboratoire ""Mobilité, Vieillissement, Exercice (MOVE) - EA 6314"" et Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Theurot', 'Affiliation': 'Laboratoire ""Mobilité, Vieillissement, Exercice (MOVE) - EA 6314"" et Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Vinches', 'Affiliation': 'École de santé publique - Département de Santé Environnementale et Santé au Travail, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Hallé', 'Affiliation': 'Department of Mechanical Engineering, Ecole de Technologie Supérieure, Montreal, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dupuy', 'Affiliation': 'Laboratoire ""Mobilité, Vieillissement, Exercice (MOVE) - EA 6314"" et Faculté des Sciences du Sport, Université de Poitiers, Poitiers, France.'}]",International journal of sports medicine,['10.1055/a-1213-5960']
2354,32920808,Edoxaban versus Warfarin in Patients with Atrial Fibrillation at the Extremes of Body Weight: An Analysis from the ENGAGE AF-TIMI 48 Trial.,"BACKGROUND


The effects of anticoagulants at extremes of body weight (BW) are not well described. The aim of this study was to analyze the pharmacokinetics/pharmacodynamics and clinical outcomes in patients randomized to warfarin, higher dose edoxaban (HDER), and lower dose edoxaban (LDER) regimens at extremes of BW in ENGAGE AF-TIMI 48.
METHODS AND RESULTS


We analyzed three BW groups: low BW (LBW: <5th percentile, ≤55 kg,  N  = 1,082), middle BW (MBW: 45th-55th percentile, 79.8-84 kg,  N  = 2,153), and high BW (HBW: >95th percentile, ≥120 kg,  N  = 1,093). In the warfarin arm, LBW patients had higher rates of stroke/systemic embolism (SSE: 6.5 vs. 4.7 in MBW vs. 1.6% in HBW,  P   trend  < 0.001), major bleeding (MB: 9.3 vs. 7.7 vs. 6.5%,  P   trend  = 0.08), and worse net clinical outcome of systemic embolic event, MB, or death (31.5 vs. 19.1 vs. 16.0%,  P   trend  < 0.0001). The time-in-therapeutic range with warfarin was lowest in LBW patients (63.0 vs. 69.3 vs. 70.1% patients,  P   trend  < 0.001). The pharmacokinetic/pharmacodynamic profile of edoxaban was consistent across BW groups. The risk of SSE was similar between HDER and warfarin for each of the three weight groups ( P   int  = 0.52,  P   int-trend  = 0.86). MB was reduced by LDER versus warfarin ( P   int  = 0.061,  P   int-trend  = 0.023), especially in LBW patients. Net clinical outcomes were improved by HDER versus warfarin ( P   int  = 0.087,  P   int-trend  = 0.027), especially in LBW patients.
CONCLUSION


Patients with LBW in ENGAGE AF-TIMI 48 had in general a more fragile clinical status and poorer international normalized ratio control. The pharmacokinetic/pharmacodynamic profile of edoxaban was consistent across extremes of BW, resulting in similar efficacy compared with warfarin, while major or clinically relevant non-MB and net outcomes were most favorable with edoxaban as compared to warfarin in LBW patients.",2020,"Net clinical outcomes were improved by HDER versus warfarin ( P   int  = 0.087,  P   int-trend  = 0.027), especially in LBW patients.
","['patients randomized to', 'Patients with Atrial Fibrillation at the Extremes of Body Weight', 'LBW patients']","['Edoxaban versus Warfarin', 'LDER versus warfarin', 'edoxaban', 'warfarin', 'edoxaban (HDER), and lower dose edoxaban (LDER', 'HDER versus warfarin']","['risk of SSE', 'time-in-therapeutic range with warfarin', 'Net clinical outcomes', 'rates of stroke/systemic embolism', 'major bleeding', 'MB', 'systemic embolic event, MB, or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.142668,"Net clinical outcomes were improved by HDER versus warfarin ( P   int  = 0.087,  P   int-trend  = 0.027), especially in LBW patients.
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena & Reggio Emilia, Modena University Hospital, Modena, Italy.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Department of Medicine, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Department of Medicine, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi Sankyo Inc., Basking Ridge, New Jersey, United States.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Munich, Germany.'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Department of Medicine, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Department of Medicine, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Department of Medicine, Harvard Medical School, Boston, Massachusetts, United States.""}]",Thrombosis and haemostasis,['10.1055/s-0040-1716540']
2355,32922469,Early Graft Function in Deceased Donor Renal Recipients: Role of N-Acetylcysteine.,"Reduced graft function (RGF) in donor renal transplant recipients is caused by oxidative damage due to extensive ischemia-reperfusion (I/R) injury during transplantation. Neutrophil gelatinase-associated lipocalin (NGAL) is a promising biomarker to detect tubular injury early after renal transplantation. N-acetylcysteine (NAC) is a potent antioxidant that can reduce I/R injury by improving oxidative damage. The aim of the present study is to assess the efficacy of NAC in improving graft function and reducing renal tubular injury in deceased donor renal transplant recipients. A double-blind, randomized clinical trial was conducted on 50 deceased donor renal transplant recipients. The patients were randomized into two groups, receiving either 600 mg NAC twice daily, or placebo (days 0 to 5). Results were assessed based on the rate of RGF, levels of plasma NGAL (p-NGAL) and the estimated glomerular filtration rate (eGFR). The rate of RGF was significantly lower in the patients receiving NAC vs. placebo (21.4% vs. 50%). The measurement of p-NGAL levels showed that the patients in the NAC group had significantly greater reduction of p-NGAL by both days 1 and 5 post-transplantation than those in the placebo group. A near steady-state eGFR level was reached by week 1 in the NAC group, however, the improvement of eGFR was significantly slower in the placebo group and a near steady-state was only achieved by week 4. NAC has promising potential in reducing tubular injury and improving graft function, evidenced by significant reduction in the rate of RGF and levels of p-NGAL.",2020,"NAC has promising potential in reducing tubular injury and improving graft function, evidenced by significant reduction in the rate of RGF and levels of p-NGAL.","['donor renal transplant recipients', 'Deceased Donor Renal Recipients', 'deceased donor renal transplant recipients', '50 deceased donor renal transplant recipients']","['NAC twice daily, or placebo', 'Neutrophil gelatinase-associated lipocalin (NGAL', 'placebo', 'NAC', 'N-acetylcysteine (NAC']","['renal tubular injury', 'tubular injury and improving graft function', 'graft function', 'A near steady-state eGFR level', 'reduction of p-NGAL', 'measurement of p-NGAL levels', 'rate of RGF, levels of plasma NGAL', 'Reduced graft function (RGF', 'improvement of eGFR', 'rate of RGF', 'glomerular filtration rate (eGFR']","[{'cui': 'C0730392', 'cui_str': 'Donor renal transplantation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}]","[{'cui': 'C4324374', 'cui_str': 'Renal tubular injury'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.116023,"NAC has promising potential in reducing tubular injury and improving graft function, evidenced by significant reduction in the rate of RGF and levels of p-NGAL.","[{'ForeName': 'Atieh', 'Initials': 'A', 'LastName': 'Modarresi', 'Affiliation': 'Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Nafar', 'Affiliation': 'Chronic Kidney Disease Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sahraei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Salamzadeh', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Ziaie', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.15546.13167']
2356,32922474,"Evaluation of Neuroprtective Effects of L-Carnitine and Fat Emulsion in the CVA Patients: A Prospective, Randomized, Double Blind, Clinical Trial.","Cerebral infarction presents with neurological deficits caused by the death of neurons in a focal area of the brain. S100B is a biomarker that increases in brain damage. Neuroprotectives can reduce the brain sequels after neurological insult. The purpose of this study was to evaluate the neuroprotective effects of L-carnitine and Fat emulsion (Lipofundin ® ) alone and in combination in patients with ischemic stroke. In a prospective, RCT, and double-blind study 100 patients with MCA ischemic cerebrovascular accident who were admitted in the first 24 h of injury entered the study. The patients were randomly assigned into four groups of L-carnitine, fat emulsion, L-carnitine plus fat emulsion and control. Fat emulsion 10%, 500 mL, was infused over 6 to 12 h and 1 gr of L-carnitine (10 mL of solution) was administered orally to patients in addition to common therapies, according to the American Heart Association and American Stroke Association (AHA/ASA) guidelines. The patients in the control group received only the usual treatment according to stroke guidelines. Blood samples before the intervention, then after 24 h, 48 h, and 7 days later were taken and immunoenzymatic colorimetric method was used for quantitative determination of S100B concentration in the patients' serum. In the within group analysis, all of our treatment interventions (except control group) have decreased S100B levels statistically significant ( P  < 0.05). Moreover, changes in observed levels of S100B before and after intervention were different between the groups and the observed differences were statistically significant ( P  = 0.01). In the GEE model, it was found that S100B levels in the L-carnitine plus fat emulsion group decreased more than the control group and this decline has been statistically significant [ P  = 0.02, 20.47 (CI 95%: 6.25-34.41)], but in comparison of L-carnitine and fat emulsion group with control group, did not reached statistical significance ( P  > 0.05). Based on the results obtained from this study, it seems that L-carnitine with fat emulsion could lead to neuroprotective effects with a significant reduction in the S100B biomarker.",2020,"In the within group analysis, all of our treatment interventions (except control group) have decreased S100B levels statistically significant ( P  < 0.05).","['patients with ischemic stroke', 'CVA Patients', '100 patients with MCA ischemic cerebrovascular accident who were admitted in the first 24 h of injury entered the study']","['L-Carnitine and Fat Emulsion', 'Fat emulsion', 'L-carnitine', 'L-carnitine and Fat emulsion (Lipofundin ® ', 'L-carnitine, fat emulsion, L-carnitine plus fat emulsion and control']",['S100B levels'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0000325', 'cui_str': '20-Methylcholanthrene'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0304483', 'cui_str': 'fat emulsions'}, {'cui': 'C0065043', 'cui_str': 'Lipofundin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}]",100.0,0.0389959,"In the within group analysis, all of our treatment interventions (except control group) have decreased S100B levels statistically significant ( P  < 0.05).","[{'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Kazemian', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Mojtahedzadeh', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Department of Neurology, Bu Ali Sina General Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Thalassemia Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Abediankenari', 'Affiliation': 'Immunogenetics Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Rafati', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abaskhanidavanloo', 'Affiliation': 'Department of Anesthesiology, Bu Ali Sina General Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohajerani', 'Affiliation': 'Department of Neurology, Bu Ali Sina General Hospital, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2020.1100952']
2357,32922504,Manual Therapy (Postisometric Relaxation and Joint Mobilization) in Knee Pain and Function Experienced by Patients with Rheumatoid Arthritis: A Randomized Clinical Pilot Study.,"Objectives


The purpose of this study was to evaluate the impact of manual therapy on the management of rheumatoid arthritis (RA) patients with knee pain.
Materials and Methods


This was a small, randomized clinical pilot study. Subjects were 46 patients with diagnosed RA, randomly assigned to the manual therapy group (postisometric relaxation and joint mobilization) or control group (standard exercise). Subjects in each group had 10 sessions of interventions, once a day with one day break after the sixth day. Outcomes included the pain intensity of knee, Knee Society Score, Oxford Knee Score, and Health Assessment Questionnaire.
Results


There were no statistically significant differences between groups, except for the pain intensity of the knee.
Conclusions


This study suggests that manual therapy (postisometric relaxation and joint mobilization) may have clinical benefits for treating knee pain and function in rheumatoid patients. Further extended studies are expected to determine the effectiveness of manual therapy in RA patients with knee pain.",2020,"There were no statistically significant differences between groups, except for the pain intensity of the knee.
","['rheumatoid patients', 'Patients with Rheumatoid Arthritis', 'Subjects were 46 patients with diagnosed RA', 'RA patients with knee pain', 'rheumatoid arthritis (RA) patients with knee pain']","['manual therapy (postisometric relaxation and joint mobilization', 'Manual Therapy (Postisometric Relaxation and Joint Mobilization', 'manual therapy', 'manual therapy group (postisometric relaxation and joint mobilization) or control group (standard exercise']","['pain intensity of the knee', 'pain intensity of knee, Knee Society Score, Oxford Knee Score, and Health Assessment Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}]",46.0,0.0541646,"There were no statistically significant differences between groups, except for the pain intensity of the knee.
","[{'ForeName': 'Mateusz Wojciech', 'Initials': 'MW', 'LastName': 'Romanowski', 'Affiliation': 'Department of Physiotherapy, Poznan University of Medical Sciences, Poznań, Poland.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Špiritović', 'Affiliation': 'Institute of Rheumatology and Clinic of Rheumatology, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Romanowski', 'Affiliation': 'Rheumatological Centre, Śrem, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Straburzyńska-Lupa', 'Affiliation': 'Rheumatological Centre, Śrem, Poland.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/1452579']
2358,32922518,"Microvascular density assessed by CD31 predicts clinical benefit upon bevacizumab treatment in metastatic colorectal cancer: results of the PassionATE study, a translational prospective Phase II study of capecitabine and irinotecan plus bevacizumab followed by capecitabine and oxaliplatin plus bevacizumab or the reverse sequence in patients in mCRC.","Background


Targeted therapies offer novel opportunities to explore biomarkers based on their mode of action. Taking this into consideration, we evaluated six angiogenesis-related proteins as potential predictive biomarkers, which expression might predict the benefit of bevacizumab treatment in patients with metastatic colorectal cancer (mCRC).
Methods


This was a phase II multicenter, two-armed, randomized study, in which patients with mCRC were treated with XELIRI (capecitabine and irinotecan) plus bevacizumab followed by XELOX (capecitabine and oxaliplatin) plus bevacizumab (Arm A) or the reverse sequence (Arm B). Tissue expression level of six prespecified candidates [microvessel density assessed by CD31, PTEN, αV integrin, CD98hc, uPAR and NRP-1] was analyzed  via  immunohistochemistry. The prognostic impact on survival was quantified using the Cox regression model. The predictive potential for benefit from Arm A  versus  Arm B treatment was investigated by fitting an interaction between the biomarkers and treatment assignment within a multivariable Cox model.
Results


In total, 74 out of 126 patients were included in the analysis. The expression of PTEN, αV integrin, uPAR and NRP-1 was not associated with progression-free survival (PFS) or overall survival (OS). For the first time, we identified that patients with tumors expressing CD98hc had a longer PFS than patients without CD98hc-expression ( p  = 0.032). More importantly, and in accordance with previous studies, low microvessel density was found to be associated with a reduced PFS [adjusted HR per doubling of CD31-expression ( p  = 0.53, 95% confidence interval: 0.30-0.95,  p  = 0.034)].
Conclusions


These results can contribute to the development of a personalized strategy for the treatment of mCRC with bevacizumab.",2020,"The expression of PTEN, αV integrin, uPAR and NRP-1 was not associated with progression-free survival (PFS) or overall survival (OS).","['patients with mCRC', 'patients in mCRC', 'patients with metastatic colorectal cancer (mCRC', 'metastatic colorectal cancer', 'In total, 74 out of 126 patients were included in the analysis']","['XELIRI (capecitabine and irinotecan) plus bevacizumab followed by XELOX (capecitabine and oxaliplatin) plus bevacizumab', 'bevacizumab', 'capecitabine and irinotecan plus bevacizumab', 'capecitabine and oxaliplatin plus bevacizumab']","['progression-free survival (PFS) or overall survival (OS', 'expression of PTEN, αV integrin, uPAR and NRP-1', 'Microvascular density', 'survival', 'Tissue expression level of six prespecified candidates [microvessel density assessed by CD31, PTEN, αV integrin, CD98hc, uPAR and NRP-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0071216', 'cui_str': 'Lymphocyte antigen CD87'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0081939', 'cui_str': 'Lymphocyte antigen CD31'}]",126.0,0.0639592,"The expression of PTEN, αV integrin, uPAR and NRP-1 was not associated with progression-free survival (PFS) or overall survival (OS).","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bianconi', 'Affiliation': 'Department of Medicine I, Division of Oncology, Comprehensive Cancer Center, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Merima', 'Initials': 'M', 'LastName': 'Herac', 'Affiliation': 'Department of Pathology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Posch', 'Affiliation': 'Division of Clinical Oncology, Comprehensive Cancer Center Graz, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Schmeidl', 'Affiliation': 'Department of Pathology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Unseld', 'Affiliation': 'Department of Medicine I, Division of Oncology, Comprehensive Cancer Center, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Kieler', 'Affiliation': 'Department of Medicine I, Division of Oncology, Comprehensive Cancer Center, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brettner', 'Affiliation': 'Department of Medicine I, Division of Oncology, Comprehensive Cancer Center, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Müllauer', 'Affiliation': 'Department of Pathology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Riedl', 'Affiliation': 'Division of Clinical Oncology, Comprehensive Cancer Center Graz, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Gerger', 'Affiliation': 'Division of Clinical Oncology, Comprehensive Cancer Center Graz, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Medicine I, Division of Oncology, Comprehensive Cancer Center, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Prager', 'Affiliation': 'Department of Medicine I, Division of Oncology, Comprehensive Cancer Center, Medical University Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}]",Therapeutic advances in medical oncology,['10.1177/1758835920928635']
2359,32922631,Donning a Novel Lower-Limb Restrictive Compression Garment During Training Augments Muscle Power and Strength.,"The popularity of graduated compression garments (GCG) in sport and exercise is largely driven by the abundance of anecdotal claims suggesting their efficacy. A new line of compression apparel, restrictive compression garments (RCG), integrate novel resistance technology into lower-limb compression garments designed to provide variable resistance to movement. This study aimed to investigate the effect of donning an RCG during a 4-week training program on selected performance variables. Twelve college-aged males were recruited for four weeks of lower-body strength-power resistance training. Participants were randomized 1:1 and blinded to (i) an intervention group (RCG;  n  = 6) that donned a lower-body RCG during training or (ii) a control group (SHAM;  n  = 6) that donned a sham during identical training. Both groups demonstrated significant increases in 1-repetition maximum (1-RM) on a seated leg press after 4 weeks (both  p  < 0.001), with RCG showing a significantly greater increase compared SHAM ( p  = 0.005,  g  = 3.35). Similarly, RCG demonstrated significantly greater increases in jump height, peak power, and average power compared to SHAM ( p  = 0.032, g = 3.44;  p  < 0.001,  g  = 4.40;  p  < 0.001,  g  = 4.50, respectively). Donning a RCG while engaging in lower-body strength-power training may augment increases 1-RM on a seated leg press, jump height, peak and average power, compared with same exercise training without an RCG.",2020,"Both groups demonstrated significant increases in 1-repetition maximum (1-RM) on a seated leg press after 4 weeks (both  p  < 0.001), with RCG showing a significantly greater increase compared SHAM ( p  = 0.005,  g  = 3.35).",['Twelve college-aged males'],"['graduated compression garments (GCG', 'intervention group (RCG;  n  = 6) that donned a lower-body RCG during training or (ii) a control group (SHAM;  n  = 6) that donned a sham during identical training', 'compression apparel, restrictive compression garments (RCG']","['1-repetition maximum (1-RM) on a seated leg press', 'jump height, peak power, and average power']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012020', 'cui_str': '6-Diazo-5-oxo-L-norleucine'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",,0.0214549,"Both groups demonstrated significant increases in 1-repetition maximum (1-RM) on a seated leg press after 4 weeks (both  p  < 0.001), with RCG showing a significantly greater increase compared SHAM ( p  = 0.005,  g  = 3.35).","[{'ForeName': 'Jaxon T', 'Initials': 'JT', 'LastName': 'Baum', 'Affiliation': 'Exercise Physiology Research Laboratory, Department of Medicine, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Carter', 'Affiliation': 'Exercise Physiology Research Laboratory, Department of Medicine, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Eric V', 'Initials': 'EV', 'LastName': 'Neufeld', 'Affiliation': 'Exercise Physiology Research Laboratory, Department of Medicine, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Dolezal', 'Affiliation': 'Exercise Physiology Research Laboratory, Department of Medicine, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.'}]",International journal of exercise science,[]
2360,32922637,"Effects of Combined Power Band Resistance Training on Sprint Speed, Agility, Vertical Jump Height, and Strength in Collegiate Soccer Players.","Soccer involves explosive physical actions requiring strength, power, and agility for optimal performance. Such attributes may be trained several ways, of which power-band resistance training has received limited attention regarding the potential for performance improvement in soccer players. This study serves to determine the effect of power-band resistance training on 1-repetition maximal (1RM) strength, speed, standing vertical jump (SVJ) height, and agility of collegiate soccer players. Seventeen male players (age: 20.47 ± 1.85 years, height: 1.77 ± 0.08 m, mass: 70.49 ± 4.15 kg) were matched and randomly allocated into either a conventional resistance group (CON,  n  = 8), or a power-band resistance training group (EXP,  n  = 9). Following a 6-week intervention, participants were re-assessed relative to their baseline values, showing improvements in 1RM squat mass (CON: +31.57%; EXP: +34.61%), 1RM deadlift mass (CON: +15.44%; EXP: +13.72%), and SVJ height (CON: +4.15%; EXP: +6.35%). Power-band resistance training produced greater results compared to conventional training in 1RM squat mass, even when between-group baseline values were controlled for (ANCOVA, F(1,14)=5.32,  p  = 0.037,        η   p   2   =   .28      ). No other between-group differences were evident, showing no clear methodological superiority. Power-band resistance training shows potential as an effective training methodology compared to conventional resistance training to improve performance variables in university soccer players.",2020,Power-band resistance training shows potential as an effective training methodology compared to conventional resistance training to improve performance variables in university soccer players.,"['university soccer players', 'soccer players', 'Collegiate Soccer Players', 'Seventeen male players (age: 20.47 ± 1.85 years, height: 1.77 ± 0.08 m, mass: 70.49 ± 4.15 kg']","['conventional resistance training', 'power-band resistance training', 'Combined Power Band Resistance Training', 'conventional resistance group (CON,  n  = 8), or a power-band resistance training']","['1RM squat mass', '1-repetition maximal (1RM) strength, speed, standing vertical jump (SVJ) height, and agility of collegiate soccer players', '1RM deadlift mass', 'Sprint Speed, Agility, Vertical Jump Height, and Strength']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517417', 'cui_str': '0.08'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]",17.0,0.0176901,Power-band resistance training shows potential as an effective training methodology compared to conventional resistance training to improve performance variables in university soccer players.,"[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Katushabe', 'Affiliation': 'Department of Human Movement Science, Nelson Mandela University, Port Elizabeth, Eastern Cape, SOUTH AFRICA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Department of Human Movement Science, Nelson Mandela University, Port Elizabeth, Eastern Cape, SOUTH AFRICA.'}]",International journal of exercise science,[]
2361,32922646,Effects of Horizontal and Incline Bench Press on Neuromuscular Adaptations in Untrained Young Men.,"The aim of the current study was to investigate the effects of horizontal and incline bench press as well as the combination of both exercises on neuromuscular adaptation in untrained young men. Forty-seven untrained men were randomly assigned to one of the three groups: 1) a horizontal bench press group (n= 15), 2) an incline bench press group (n= 15), and 3) a combination (horizontal + incline) group (n= 17). Training was conducted once a week for eight weeks, with equalized number of sets among groups. Muscle thickness, isometric strength and electromyography (EMG) amplitude of the pectoralis major were measured one week before and after the training period. There was no difference between groups for the change in horizontal bench press isometric strength (~ 10 kg increase, p=0.776) or incline bench press isometric strength (~ 11 kg increase, p=0.333). Changes in muscle thickness differed only in one of the three sites. The changes in the second intercostal space of the pectoralis major was greatest in the incline pressure group compared with the horizontal [mean difference (95% CI) of 0.62 (0.23, 1.0) cm, p=0.003] and combination groups [mean difference (95% CI) of 0.50 (0.14, 0.86) cm, p=0.008]. The change in EMG amplitude following training differed between groups in only one out of the four sites. The present results indicate that strength and conditioning professionals might consider that horizontal and incline bench press exercises, or a combination of both exercises can render similar change in general strength.",2020,"There was no difference between groups for the change in horizontal bench press isometric strength (~ 10 kg increase, p=0.776) or incline bench press isometric strength (~ 11 kg increase, p=0.333).","['untrained young men', 'Forty-seven untrained men', 'Untrained Young Men']","['horizontal bench press group (n= 15), 2) an incline bench press group (n= 15), and 3) a combination (horizontal + incline', 'Horizontal and Incline Bench Press']","['EMG amplitude', 'incline bench press isometric strength', 'Neuromuscular Adaptations', 'horizontal bench press isometric strength', 'Muscle thickness, isometric strength and electromyography (EMG) amplitude of the pectoralis major', 'muscle thickness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0230616,"There was no difference between groups for the change in horizontal bench press isometric strength (~ 10 kg increase, p=0.776) or incline bench press isometric strength (~ 11 kg increase, p=0.333).","[{'ForeName': 'Suene F N', 'Initials': 'SFN', 'LastName': 'Chaves', 'Affiliation': 'Federal Institute of Sudeste of Minas Gerais, Rio Pomba, MG, BRAZIL.'}, {'ForeName': 'Valdinar A', 'Initials': 'VA', 'LastName': 'Rocha-JÚnior', 'Affiliation': 'National Police Academy, Federal Police, Brasília, DF, BRAZIL.'}, {'ForeName': 'Irismar G A', 'Initials': 'IGA', 'LastName': 'EncarnaÇÃo', 'Affiliation': 'Federal Institute of Sudeste of Minas Gerais, Rio Pomba, MG, BRAZIL.'}, {'ForeName': 'Hugo C', 'Initials': 'HC', 'LastName': 'Martins-Costa', 'Affiliation': 'Pontifical Catholic University of Minas Gerais, Campus Coração Eucarístico, Belo Horizonte, MG, BRAZIL.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'University of Oklahoma, Department of Health and Exercise Science, Norman, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Coelho', 'Affiliation': 'Sport Center, Federal University of Ouro Preto, Ouro Preto, MG, BRAZIL.'}, {'ForeName': 'Frederico S C', 'Initials': 'FSC', 'LastName': 'Franco', 'Affiliation': 'Federal Institute of Sudeste of Minas Gerais, Rio Pomba, MG, BRAZIL.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Loenneke', 'Affiliation': 'Kevser Ermin Applied Physiology Laboratory, Department of Health, Exercise Science, and Recreation Management, The University of Mississippi, Oxford, USA.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'University of Brasília, Brasília, DF, BRAZIL.'}, {'ForeName': 'JoÃo B', 'Initials': 'JB', 'LastName': 'Ferreira-JÚnior', 'Affiliation': 'Federal Institute of Sudeste of Minas Gerais, Rio Pomba, MG, BRAZIL.'}]",International journal of exercise science,[]
2362,32922648,Changes in Selected Physiological Parameters Following a Training Block of Specific Circuit Training Among National Top-level Basketball Players.,"The study aims at measuring the effects of six weeks of specific circuit training (SCT) according to the 15-15 modality, on selected physiological parameters in national top-level basketball players. It was an intervention study, undertaken with 44 senior players randomly assigned to two groups depending on the program: intervention (IG: n = 22; SCT) and control (CG: n = 22; usual content of the defending champion team's), submitted to a six-week training block. The heart rate recovery at 1 (HRR1) and then 2 (HRR2) minutes, the double product (DP) and  V̇ O 2 max were assessed prior to and at the end of the training period. As appropriate, the Student t-test on paired or independent samples, was used to compare measures and groups. At the end of the training period, the HRR1 decreased by 14.2% (p = 0.01) and 14.1% (p = 0.03) respectively in IG and CG. The mean HRR2 was higher in IG than in GC (63 ± 8 bpm  versus  57 ± 6 bpm, p = 0.003) at the end of the training period. The variation of DP in IG was not significant (p = 0. 42) while it increased by 7.2% (p = 0.0005) in CG. The  V̇ O 2 max increased by 6.5% (p < 0. 001) in IG but not in CG (p = 0.50). The specific circuit training block in the 15-15 modality improved heart rate recovery at one minute and  V̇ O 2 max, but had no effect on the double product in the basketball players studied.",2020,The  V̇ O 2 max increased by 6.5% (p < 0. 001) in IG but not in CG (p = 0.50).,"['national top-level basketball players', '44 senior players randomly assigned to two groups depending on the', 'National Top-level Basketball Players']","['specific circuit training (SCT', 'Specific Circuit Training', ""program: intervention (IG: n = 22; SCT) and control (CG: n = 22; usual content of the defending champion team's), submitted to a six-week training block""]","['HRR1', 'heart rate recovery', 'V̇ O 2 max', 'mean HRR2', 'variation of DP in IG', 'heart rate recovery at 1 (HRR1) and then 2 (HRR2) minutes, the double product (DP) and  V̇']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0249781,The  V̇ O 2 max increased by 6.5% (p < 0. 001) in IG but not in CG (p = 0.50).,"[{'ForeName': 'Brigitte A', 'Initials': 'BA', 'LastName': 'Tonon', 'Affiliation': 'Sports, Health and Evaluation Research Unit; National Institute of Youth, Physical Education and Sport, University of Abomey-Calavi, Porto-Novo, REPUBLIC OF BENIN.'}, {'ForeName': 'Polycarpe N', 'Initials': 'PN', 'LastName': 'Gouthon', 'Affiliation': 'Sports, Health and Evaluation Research Unit; National Institute of Youth, Physical Education and Sport, University of Abomey-Calavi, Porto-Novo, REPUBLIC OF BENIN.'}, {'ForeName': 'Issiako Bio', 'Initials': 'IB', 'LastName': 'Nigan', 'Affiliation': 'Sports, Health and Evaluation Research Unit; National Institute of Youth, Physical Education and Sport, University of Abomey-Calavi, Porto-Novo, REPUBLIC OF BENIN.'}, {'ForeName': 'Romario V', 'Initials': 'RV', 'LastName': 'Akpatchi', 'Affiliation': 'Sports, Health and Evaluation Research Unit; National Institute of Youth, Physical Education and Sport, University of Abomey-Calavi, Porto-Novo, REPUBLIC OF BENIN.'}, {'ForeName': 'Basile K', 'Initials': 'BK', 'LastName': 'Nouatin', 'Affiliation': 'Sports, Health and Evaluation Research Unit; National Institute of Youth, Physical Education and Sport, University of Abomey-Calavi, Porto-Novo, REPUBLIC OF BENIN.'}]",International journal of exercise science,[]
2363,32922695,Infection risk stratification in total knee joint arthroplasty using a new scoring system.,"Periprosthetic joint infection (PJI) is a catastrophic complication of total knee arthroplasty (TKA) adding significant costs to the health care system with increasing morbidity and mortality. The goal of this study was to develop a prognostic scoring system that could risk-stratify patients undergoing TKA for the risk of PJI. The study included 150 patients who underwent primary TKA from June 2012 to February2016. There were 60 patients in group I who were not risk stratified using the scoring system, while 90 patients were assigned to group II and were prospectively assigned scores based on the scoring system. Points were assigned for each pre-op variable and a scoring chart was developed. Group II patients scoring 4 or more were counseled to optimize their modifiable risk factors before proceeding with surgery. Retrospective chart review was done for patients in group I to find out their risk score for the study purpose. Nine out of 60 patients in group I were found to have score above 4 based on the chart review, of which 4 patients got infected (P<0.05). None of the group II patients got infected after TKA. In conclusion, our scoring system is an objective scoring system for preoperative risk stratification of patients undergoing TKA, thus helping identification and optimization of the risk factors preoperatively to decrease the risk of PJI.",2020,None of the group II patients got infected after TKA.,"['60 patients in group I who were not risk stratified using the scoring system, while 90 patients', 'risk-stratify patients undergoing TKA for the risk of PJI', 'total knee joint arthroplasty', '150 patients who underwent primary TKA from June 2012 to February2016', '60 patients in group']","['total knee arthroplasty (TKA', 'Periprosthetic joint infection (PJI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}]",[],150.0,0.0222812,None of the group II patients got infected after TKA.,"[{'ForeName': 'Prabhudev Prasad', 'Initials': 'PP', 'LastName': 'Purudappa', 'Affiliation': 'Department of Orthopedics, VA Medical center, Boston, MA, USA.'}, {'ForeName': 'Prasanth J', 'Initials': 'PJ', 'LastName': 'Sudevan', 'Affiliation': 'Department of Orthopedics, KG Hospital and Postgraduate Institute, Coimbatore, India.'}, {'ForeName': 'Jayadev', 'Initials': 'J', 'LastName': 'Chandrasekharan', 'Affiliation': 'Department of Orthopedics, KG Hospital and Postgraduate Institute, Coimbatore, India.'}, {'ForeName': 'Senthil N', 'Initials': 'SN', 'LastName': 'Sambandam', 'Affiliation': 'Department of Orthopedics, VA Medical center, Boston, MA, USA.'}, {'ForeName': 'Varatharaj', 'Initials': 'V', 'LastName': 'Mounasamy', 'Affiliation': 'Department of Orthopedics, VA Medical center, Dallas, TX, USA.'}, {'ForeName': 'Sushruthi', 'Initials': 'S', 'LastName': 'Varatharaj', 'Affiliation': 'Medical Student, University of Texas, El Paso, TX, USA.'}, {'ForeName': 'Om P', 'Initials': 'OP', 'LastName': 'Sharma', 'Affiliation': 'Essentia Health, Detroit Lakes, MN, USA.'}]",Orthopedic reviews,['10.4081/or.2020.8394']
2364,32922722,Cost-consequence analysis of self-administration of medication during hospitalization: a pragmatic randomized controlled trial in a Danish hospital setting.,"Objectives


The objective of this study was to evaluate the costs and consequences of introducing ""self-administration of medication"" (SAM) during hospitalization as compared with nurse-led dispensing and administration of medication.
Methods


This pragmatic randomized controlled trial was performed in a Danish Cardiology Unit. Patients ⩾18 years old capable of self-administering medication were eligible. In the intervention group, patients self-administered their medication. In the control group, medication was dispensed and administered by nurses. The implementation of SAM was used to evaluate the cost-consequences. The micro-costing analysis used the hospital perspective and a short-term incremental costing approach. The costs for medication, materials, and nursing time were included. Consequences included the dispensing error proportion, patients' perceptions regarding medication, satisfaction, and deviations in the medication list at follow-up. In addition, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge was included.
Results


The total cost (TC) per patient in the intervention group was 49.9€ (95% CI: 46.6-53.2) compared with 52.6€ (95% CI: 46.6-58.6) in the control group. The difference between the groups was not statistically significant ( p  = 0.09). Sensitivity analysis consistently showed TCs favoring the intervention. The dispensing error proportion was 9.7% (95% CI: 7.9-11.6) in the intervention group compared with 12.8% (95% CI: 10.9-15.6) in the control group. The difference was statistically significant ( p  = 0.02). The analysis also found changes in the perceptions regarding medication (indicating higher medication adherence), increased satisfaction, and fewer patients with deviations in the medication list at follow-up. No statistically significant differences between the groups in relation to readmissions and GP contacts within 30 days were observed.
Conclusions


SAM seems to cost less although the cost difference was small and not statistically significant. As SAM had positive effects on patient outcomes, the results indicate that SAM may be cost-effective.
Plain language summary


Self-administration of medication: a research study of the costs and consequences   Objectives  To evaluate the costs and consequences of introducing ""self-administration of medication"" (SAM) during hospitalization compared to medication dispensed by nurses.  Methods  This research study included patients ≥18 years capable of self-administering medication and was performed in a Danish cardiology unit. Patients self-administered their own medication during hospitalization in the intervention group, whereas nurses dispensed and administered the medication in the control group. Patients were allocated between groups by randomization. The costs of SAM were analyzed from a hospital perspective and included costs for medication, materials, and nursing time. The consequences included the proportion of dispensing errors, patients' perceptions regarding medication, patient satisfaction, deviations in the medication list at follow-up, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge.  Results  The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group ( p  = 0.09). The cost difference between groups was not significant. The proportion of dispensing errors was significantly lower in the intervention group compared to the control group. In addition the research study found changes in the perceptions regarding medication, increased satisfaction, and fewer patients with deviations in the medication list at follow-up. For readmissions and GP contacts within 30 days no significant differences between groups were found.  Conclusion  SAM cost less or equal to medication dispensing and administration by nurse. SAM had positive impacts on patient outcomes. Therefore, SAM may be cost-effective.",2020,The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group ( p  = 0.09).,"['patients\u2009≥18 years capable of self-administering medication and was performed in a Danish cardiology unit', 'Patients ⩾18\u2009years old capable of self-administering medication were eligible', 'Danish Cardiology Unit']","['self-administration of medication"" (SAM', 'Plain language summary\n\n\nSelf-administration of medication']","['relation to readmissions and GP contacts', 'total cost per patient', 'costs for medication, materials, and nursing time', 'total cost (TC', 'costs of SAM', ""dispensing error proportion, patients' perceptions regarding medication, satisfaction, and deviations in the medication list"", 'number of readmissions and general practitioner (GP) contacts', 'dispensing error proportion', ""proportion of dispensing errors, patients' perceptions regarding medication, patient satisfaction, deviations in the medication list at follow-up, the number of readmissions and general practitioner (GP) contacts"", 'proportion of dispensing errors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0389782,The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group ( p  = 0.09).,"[{'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Randers Regional Hospital, Dronningborg Boulevard 16D, Randers NØ, 8930, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'de Thurah', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Health, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Health, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Olesen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Clinical Pharmacy, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Signe Bredsgaard', 'Initials': 'SB', 'LastName': 'Sørensen', 'Affiliation': 'Medical Department, Cardiology unit, Randers Regional Hospital, Denmark.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Enemark', 'Affiliation': 'Department of Public Health, Aarhus University, Denmark.'}]",Therapeutic advances in drug safety,['10.1177/2042098620929921']
2365,32922784,Interactive patient education via an audience response system in cardiac rehabilitation.,"Objectives


Patient education and compliance play an important role in the success of rehabilitation in cardiovascular diseases. The aim of this study is to analyze whether interactive learning methods, in this study, the audience response system with a ""clicker,"" can improve the learning success of patients during and after their rehabilitation process.
Methods


In a randomized, prospective cohort study, a total of 260 patients were randomized to either an interactive training group using Athens audience response system or to a control group without the use of audience response system during the educational sessions. Patients were taught and tested on four different topics concerning their primary disease: heart failure, arterial hypertension, prevention of cardiovascular diseases, and coronary heart disease. After each session, the patients had to answer questions on the previously taught topics via questionnaires. These questions were asked again at the day of discharge, as well as 3 and 12 months after discharge. Additional information on the patients' health, plus their mental status, was gathered with the help of further questionnaires (HADS and SF-12).
Results


A total of 260 patients (201 men and 59 women) were recruited. The patients were on average 61.1 ± 11 years old. A significant short-term effect on the patients' knowledge about their disease was found immediately after the educational sessions in the intervention group. However, there was no long-term effect in either the intervention or control group. Although there was no statistical significance found in any of the observations, a positive short-term effect on learning capacity as well as positive trends in mental and physical health after discharge could be found in patients after the use of audience response system during their rehabilitation.
Conclusion


This study provides interesting and new data on the use of an interactive learning method for patients to gain knowledge about their primary disease and eventually improve their physical and mental health status in a long-term perspective. By implementing different and new ways of teaching and interaction during the hospitalization, not only patients, but also medical staff and caregivers could benefit.",2020,A significant short-term effect on the patients' knowledge about their disease was found immediately after the educational sessions in the intervention group.,"['patients were on average 61.1\u2009±\u200911\u2009years old', 'Patients were taught and tested on four different topics concerning their primary disease: heart failure, arterial hypertension, prevention of cardiovascular diseases, and coronary heart disease', '260 patients', 'patients during and after their rehabilitation process', '260 patients (201 men and 59 women']","['interactive training group using Athens audience response system or to a control group without the use of audience response system during the educational sessions', 'interactive learning method']","['learning capacity', 'learning success', ""patients' knowledge about their disease""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0815244', 'cui_str': 'Interactive Learning'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",260.0,0.0282242,A significant short-term effect on the patients' knowledge about their disease was found immediately after the educational sessions in the intervention group.,"[{'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Stoevesandt', 'Affiliation': 'Department and Outpatient Clinic for Radiology, University Hospital Halle (Saale), Halle (Saale), Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Weber', 'Affiliation': 'Institute for Health and Nursing Science, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wienke', 'Affiliation': 'Institute of Medical Epidemiology, Biometry, and Information Technology, University Hospital Halle (Saale), Halle (Saale), Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Bethge', 'Affiliation': 'Paracelsus-Harz-Klinik Bad Suderode, Quedlinburg, Germany.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Heinze', 'Affiliation': 'Paracelsus-Harz-Klinik Bad Suderode, Quedlinburg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kowoll', 'Affiliation': 'Coordination Center for Clinical Studies, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Schlitt', 'Affiliation': 'Paracelsus-Harz-Klinik Bad Suderode, Quedlinburg, Germany.'}]",SAGE open medicine,['10.1177/2050312120942118']
2366,32928582,Blunted nutrient-response pathways in adipose tissue following high fat meals in men with metabolic syndrome: A randomized postprandial transcriptomic study.,"BACKGROUND


Excessive adipose tissue is central to disease burden posed by the Metabolic Syndrome (MetS). Whilst much is known of the altered transcriptomic regulation of adipose tissue under fasting conditions, little is known of the responses to high-fat meals.
METHODS


Nineteen middle-aged males (mean ± SD 52.0 ± 4.6 years), consumed two isocaloric high-fat, predominately dairy-based or soy-based, breakfast meals. Abdominal subcutaneous adipose biopsies were collected after overnight fast (0 h) and 4 h following each meal. Global gene expression profiling was performed by microarray (Illumina Human WG-6 v3).
RESULTS


In the fasted state, 13 genes were differently expressed between control and MetS adipose tissue (≥1.2 fold-difference, p < 0.05). In response to the meals, the control participants had widespread increases in genes related to cellular nutrient responses (≥1.2 fold-change, p < 0.05; 2444 & 2367 genes; dairy & soy, respectively). There was blunted response in the MetS group (≥1.2 fold-change, p < 0.05; 332 & 336 genes; dairy & soy, respectively).
CONCLUSIONS


In middle-aged males with MetS, a widespread suppression of the subcutaneous adipose tissue nutrient responsive gene expression suggests an inflexibility in the transcriptomic responsiveness to both high-fat meals.",2020,"There was blunted response in the MetS group (≥1.2 fold-change, p < 0.05; 332 & 336 genes; dairy & soy, respectively).
","['men with metabolic syndrome', 'Nineteen middle-aged males (mean\xa0±', 'middle-aged males with MetS']",[],"['Abdominal subcutaneous adipose biopsies', 'blunted response', 'cellular nutrient responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",[],"[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",13.0,0.03354,"There was blunted response in the MetS group (≥1.2 fold-change, p < 0.05; 332 & 336 genes; dairy & soy, respectively).
","[{'ForeName': 'Aimee L', 'Initials': 'AL', 'LastName': 'Dordevic', 'Affiliation': 'Department of Nutrition, Dietetics & Food, Monash University, Melbourne, Australia. Electronic address: aimee.dordevic@monash.edu.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Coort', 'Affiliation': 'Department of Bioinformatics - BiGCaT, NUTRIM School of Nutrition and Metabolism in Translational Research, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Chris T', 'Initials': 'CT', 'LastName': 'Evelo', 'Affiliation': 'Department of Bioinformatics - BiGCaT, NUTRIM School of Nutrition and Metabolism in Translational Research, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Murgia', 'Affiliation': 'School of Agriculture and Food, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Department of Nutrition, Dietetics & Food, Monash University, Melbourne, Australia; Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Maxine P', 'Initials': 'MP', 'LastName': 'Bonham', 'Affiliation': 'Department of Nutrition, Dietetics & Food, Monash University, Melbourne, Australia.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Larsen', 'Affiliation': 'Department of Physiology, Anatomy, and Microbiology, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Gran', 'Affiliation': 'Faculty of Health, Deakin University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand; The Riddet Institute, Massey University, Palmerston North, New Zealand; Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research, Singapore.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.024']
2367,32920824,An economic evaluation of the randomised controlled trial of topical corticosteroid and home-based narrowband UVB for active and limited vitiligo (The HI-Light Trial).,"BACKGROUND


Economic evidence for vitiligo treatments is absent.
OBJECTIVE


To determine the cost-effectiveness of (a) hand-held narrowband-UVB (NB-UVB) and (b) combination of topical corticosteroid (TCS) and NB-UVB compared to TCS for localised vitiligo.
METHODS


Cost-effectiveness analysis alongside a pragmatic, 3-arm, placebo-controlled RCT with 9 months' treatment. 517 Adults and children (aged ≥5 years) with active vitiligo affecting <10% of skin recruited from secondary care and community were randomised 1:1:1 to receive: TCS; NB-UVB; or both. Cost per successful treatment (measured on the Vitiligo Noticeability Scale) was estimated. Secondary cost-utility analyses measured QALYs using the EQ-5D-5L for those aged 11+ and CHU-9D for those aged 5 to <18.
RESULTS


Mean (SD) cost per participant was £774.4 (83.71) for NB-UVB, £813.38 (111.39) for combination treatment and £599.98 (96.18) for TCS. In analyses adjusted for age and target patch location, incremental difference in cost for combination treatment compared to TCS was £211.46 (95% CI 188.10 to 234.81), corresponding to a risk difference of 10.94% (Number-Needed-To-Treat (NNT= 9). Incremental cost was £1,932.35 per successful treatment. The incremental difference in cost for NB-UVB compared to TCS was £173.44 (95% CI 150.55 to 196.32) with a risk difference of 5.20% (NNT=19). Incremental cost was £3,335.74 per successful treatment.
CONCLUSION


Combination treatment, compared to TCS alone, has a lower incremental cost per additional successful treatment than NB-UVB only. Combination treatment would be considered cost effective if decision makers are willing to pay £1,932 per additional treatment success.",2020,"Mean (SD) cost per participant was £774.4 (83.71) for NB-UVB, £813.38 (111.39) for combination treatment and £599.98",['517 Adults and children (aged ≥5 years) with active vitiligo affecting <10% of skin recruited from secondary care and community'],"['TCS', 'TCS; NB-UVB', 'placebo-controlled RCT', ' hand-held narrowband-UVB (NB-UVB) and (b) combination of topical corticosteroid (TCS) and NB-UVB', 'topical corticosteroid and home-based narrowband UVB']","['Incremental cost', 'Vitiligo Noticeability Scale', 'Mean (SD) cost', 'cost for NB-UVB']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}]",517.0,0.296467,"Mean (SD) cost per participant was £774.4 (83.71) for NB-UVB, £813.38 (111.39) for combination treatment and £599.98","[{'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Sach', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Batchelor', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Akram', 'Affiliation': 'Department of Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Chalmers', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, UK.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Haines', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, UK.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Meakin', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Ravenscroft', 'Affiliation': ""Department of Paediatric Dermatology, Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Department of Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santer', 'Affiliation': 'Primary Care, Population Sciences & Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, UK.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Whitton', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, UK.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, UK.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Cheung', 'Affiliation': 'Cannock Chase Hospital and New Cross Hospital, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hamad', 'Affiliation': 'Cannock Chase Hospital and New Cross Hospital, The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': ""St Luke's Hospital, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.""}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Ingram', 'Affiliation': 'Division of Infection and Immunity, Cardiff University, Cardiff, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Levell', 'Affiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.'}, {'ForeName': 'J M R', 'Initials': 'JMR', 'LastName': 'Goulding', 'Affiliation': 'Solihull Hospital, University Hospitals of Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makrygeorgou', 'Affiliation': 'West Glasgow Ambulatory Care Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bewley', 'Affiliation': 'Whipps Cross Hospital and The Royal London Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ogboli', 'Affiliation': ""Birmingham Children's Hospital, Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stainforth', 'Affiliation': 'York Hospital, York Teaching Hospital NHS Foundation Trust, York, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferguson', 'Affiliation': 'Royal Derby Hospital and the London Road Community Hospital, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Laguda', 'Affiliation': 'Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wahie', 'Affiliation': 'University Hospital of North Durham, County Durham and Darlington NHS Foundation Trust, Durham, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Azad', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rajasekaran', 'Affiliation': 'Birmingham City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Eleftheriadou', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.19554']
2368,32920843,Letrozole versus clomiphene citrate for ovulation induction in anovulatory women with PCOS: A randomized controlled trial.,"OBJECTIVE


To compare the efficacy of the letrozole and clomiphene citrate (CC) for ovulation induction in infertile women with polycystic-ovarian-syndrome (PCOS).
METHODS


In this assessor blind randomized controlled trial 90 infertile women with PCOS were randomized to receive either letrozole or CC for ovulation induction in incremental doses for a maximum of three cycles. Main outcome measures studied were endometrial thickness, ovulation rate, pregnancy rate, rate of mono-follicular development and time to conception.
RESULTS


Mean endometrial thickness was 9.86 ±2.32 mm and 9.39 ± 2.06 mm with letrozole and clomiphene respectively (p = 0.751). Cumulative ovulation rate was 86.73 % & 85.21% with letrozole & clomiphene respectively (p =0.751). Pregnancy was achieved in 42.2% women in letrozole group and 20.0% in clomiphene group (p=0.04). Mono-follicular development was seen in 68.47% of ovulatory cycles in letrozole group compared to 44.89 % in clomiphene group (p=0.000). Mean time to achieve pregnancy was significantly shorter (log rank p = .042) with letrozole (9.65 weeks) than with CC (11.07).
CONCLUSION


Letrozole is a better alternative for ovulation induction in anovulatory women with PCOS as pregnancy rates are higher, time to pregnancy is shorter and chances of multiple pregnancy are less due to high mono-follicular growth.",2020,"Mean time to achieve pregnancy was significantly shorter (log rank p = .042) with letrozole (9.65 weeks) than with CC (11.07).
","['anovulatory women with PCOS', '90 infertile women with PCOS', 'infertile women with polycystic-ovarian-syndrome (PCOS']","['letrozole or CC', 'letrozole and clomiphene citrate (CC', 'letrozole', 'Letrozole', 'letrozole & clomiphene', 'clomiphene', 'letrozole and clomiphene', 'clomiphene citrate']","['Pregnancy', 'Mean endometrial thickness', 'Cumulative ovulation rate', 'endometrial thickness, ovulation rate, pregnancy rate, rate of mono-follicular development and time to conception', 'Mean time to achieve pregnancy', 'Mono-follicular development']","[{'cui': 'C0429468', 'cui_str': 'Anovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]",90.0,0.27462,"Mean time to achieve pregnancy was significantly shorter (log rank p = .042) with letrozole (9.65 weeks) than with CC (11.07).
","[{'ForeName': 'Shavina', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Shekhar', 'Affiliation': 'Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13375']
2369,32920941,Pragmatic multicentre factorial randomised controlled trial testing measures to reduce surgical site infection in low- and middle-income countries: study protocol of the FALCON trial.,"BACKGROUND


Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
METHODS


FALCON is a pragmatic, multicentre, 2x2 factorial, stratifiedrandomised controlled trial (RCT), with an internal feasibility study, which will address the need for evidence on measures to reduce SSI rates in patients in LMICs undergoing abdominal surgery. The primary objective of FALCON is to assess whether (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, and (2) triclosan-coated suture versus non-coated suture for fascial closure, reduce SSI at 30-days post-surgery for (i) clean-contaminated and (ii) contaminated/ dirty abdominal wounds. Patients with predicted clean-contaminated or contaminated/ dirty wounds with abdominal skin incision ≥5cm will be randomised 1:1:1:1 between (1) 2% alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, and (4) 10% aqueous povidone-iodine and triclosan-coated suture. The two strata (clean-contaminated versus contaminated/ dirty wounds) are separately powered. Overall, FALCON aims to recruit 5,480 patients. The primary outcome is SSI at 30-days, based on the Centers for Disease Control definition of SSI.
DISCUSSION


FALCON will deliver high quality evidence that is generalisable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings.",2020,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","['5,480 patients', 'Patients with predicted clean-contaminated or contaminated/ dirty wounds with abdominal skin incision ≥5cm', 'patients in LMICs undergoing abdominal surgery', 'low- and middle-income countries']","['alcoholic chlorhexidine', 'alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, and (4) 10% aqueous povidone-iodine and triclosan-coated suture', 'povidone-iodine for skin preparation, and (2) triclosan-coated suture versus non-coated suture for fascial closure']","['SSI rates', 'SSI at 30-days, based on the Centers for Disease Control definition of SSI', 'surgical site infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0574780', 'cui_str': 'Wound dirty'}, {'cui': 'C0222166', 'cui_str': 'Skin structure of abdomen'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]",5480.0,0.323638,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","[{'ForeName': 'Dmitri', 'Initials': 'D', 'LastName': 'Nepogodiev', 'Affiliation': 'NIHR Global Research Health Unit on Global Surgery, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Aneel', 'Initials': 'A', 'LastName': 'Bhangu', 'Affiliation': 'NIHR Global Research Health Unit on Global Surgery, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Aneel', 'Initials': 'A', 'LastName': 'Bhangu', 'Affiliation': 'NIHR Global Research Health Unit on Global Surgery, University of Birmingham, Birmingham, United Kingdom.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15354']
2370,32920973,Dietary Rapeseed Oil Supplementation Reduces Hepatic Steatosis in Obese Men - A Randomized Controlled Trial.,"SCOPE


Obesity is associated with non-alcoholic fatty liver disease (NAFLD) but effective treatment is limited. Dietary supplementation of n-3 polyunsaturated fatty acids, specifically alpha linolenic acid (ALA), can resolve intrahepatic lipid content (IHL). This study investigated the effect of daily supplementation of either refined rapeseed (RA), which contains high amounts of ALA, or refined olive (OL) oil on IHL and glucose metabolism in NAFLD patients.
METHODS AND RESULTS


27 obese men consumed an isocaloric diet including either 50 g of RA or OL daily for eight weeks. Hepatic proton magnetic resonance spectroscopy, hyperinsulinemic-euglycemic clamp studies and blood tests were performed before and at the end of the study. BMI did not change for RA or OL. At eight weeks a significant reduction in IHL was observed for RA (13.1±1.6 before versus 11.1±1.6 % after intervention) versus OL (13.3±2.5 before versus 15.7±2.7 % after intervention). For RA, a 21% reduction (P<0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) was observed after eight weeks.
CONCLUSION


RA has a beneficial effect on hepatic lipid metabolism as shown by reduced IHL and serum FFA. RA induced IL-6 production seems to be liver protective confirming previous results. This article is protected by copyright. All rights reserved.",2020,"For RA, a 21% reduction (P<0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) was observed after eight weeks.
","['27 obese men consumed an', 'Obese Men', 'NAFLD patients']","['isocaloric diet including either 50\xa0g of RA or OL', 'n-3 polyunsaturated fatty acids, specifically alpha linolenic acid (ALA', 'refined rapeseed (RA), which contains high amounts of ALA, or refined olive (OL) oil', 'Dietary Rapeseed Oil Supplementation', 'OL']","['BMI', 'serum interleukin-6 (IL-6', 'Hepatic Steatosis', 'serum free fatty acids (FFA', 'IHL and serum FFA', 'hepatic lipid metabolism', 'IHL']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0072982', 'cui_str': 'Brassica Napus Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",27.0,0.0850338,"For RA, a 21% reduction (P<0.02) in serum free fatty acids (FFA) and a 1.68-fold increase (P = 0.03) of serum interleukin-6 (IL-6) was observed after eight weeks.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kruse', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Margrit', 'Initials': 'M', 'LastName': 'Kemper', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Gancheva', 'Affiliation': 'German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Osterhoff', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Dannenberger', 'Affiliation': 'Leibniz Institute for Farm Animal Biology, Dummerstorf, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Markgraf', 'Affiliation': 'German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hierholzer', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Ernst von Bergmann Hospital, Potsdam, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'German Center for Diabetes Research (DZD), München-Neuherberg, Germany.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000419']
2371,32921065,A clinical study on the treatment of granulomatous lobular mastitis by the external application of the internal pus-expelling decoction and operation.,"BACKGROUND


The objective of this study was to evaluate the clinical efficacy of the external application of internal expulsion pus-expelling decoction (IEPED) combined with surgery in the treatment of granulomatous lobular mastitis (GLM).
METHODS


A total of 110 patients in our hospital with sepsis GLM were randomly divided into two groups: treatment group (n=60, the wound was treated with IEPED) and control group (n=50, the wound was not treated with IEPED). We assessed the recurrence, contra lateral breast form, and aesthetic evaluation of the patients in the two groups.
RESULTS


The total effective rates in the patients in the treatment group and the control group were 90% and 68%, respectively, after the preoperative pretreatment and before radical surgery (P<0.05). After 10 days of receiving the debridement treatment, the two groups were compared in term of physical signs scores and the difference was statistically significant (P<0.05). Within one year of the regular follow-up after treatment, 0 case recurred in the treatment group and 1 case recurred in the control group (P>0.05). In the treatment group, 30 cases showed excellent results in the aesthetic evaluation of breast appearance, 18 cases were good, and the overall excellent and good rate was up to 80%. In the control group, 12 cases showed excellent results and 16 cases showed good results, with the overall excellent and good rate reaching 56% (P<0.05).
CONCLUSIONS


In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.",2020,"In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.","['granulomatous lobular mastitis (GLM', '110 patients in our hospital with sepsis GLM']","['GLM', 'IEPED) and control group (n=50, the wound was not treated with IEPED', 'internal pus-expelling decoction and operation', 'internal expulsion pus-expelling decoction (IEPED) combined with surgery']","['recurrence, contra lateral breast form, and aesthetic evaluation', 'aesthetic evaluation of breast appearance', 'total effective rates', 'overall excellent and good rate']","[{'cui': 'C0439667', 'cui_str': 'Granulomatous'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439667', 'cui_str': 'Granulomatous'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0024894', 'cui_str': 'Mastitis'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0034161', 'cui_str': 'Pus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1286083', 'cui_str': 'Form of breast'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1286082', 'cui_str': 'Appearance of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",18.0,0.0159327,"In patients with abscess debridement of GLM, the external application of IEPED can significantly reduce the primary lesion of patients with abscess GLM, reduce the surgical resection area, and maximize the preservation of the patients' breast appearance.","[{'ForeName': 'Peng-Zhou', 'Initials': 'PZ', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xiao-Guang', 'Initials': 'XG', 'LastName': 'Shi', 'Affiliation': 'Department of Galactophore Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, China. shixgtcm915@163.com.'}, {'ForeName': 'Xi-Meng', 'Initials': 'XM', 'LastName': 'Zuo', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Lai', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ze', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhen-Rui', 'Initials': 'ZR', 'LastName': 'Yang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie-Li', 'Initials': 'JL', 'LastName': 'Liu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}]",Annals of palliative medicine,['10.21037/apm-19-684']
2372,32921090,Efficacy of self-heating calf sleeves for preventing deep vein thrombosis in lung cancer patients who undergo video-assisted thoracoscopic surgery lobectomy.,"BACKGROUND


Deep vein thrombosis (DVT) poses a considerable perioperative risk in patients who undergo surgical procedures. This study set out to determine the efficacy of self-heating calf sleeves (SHCSs) in preventing postoperative DVT in lung cancer patients undergoing VATS lobectomy.
METHODS


This study included 557 participants who underwent video-assisted thoracoscopic surgery (VATS) lobectomy between June, 2018 and June, 2019. The participants were randomly divided into two groups: the SHCS group and the control group. SHCS was applied to the patients intraoperatively. Each patient was subjected to Doppler ultrasound and D-dimer examination preoperatively and postoperatively. Signs and symptoms of DVT were monitored daily. Incidences of DVT were compared between the two groups.
RESULTS


Based on Color Doppler ultrasonography performed on day 2 after surgery, 42 of the 276 patients (15.20%) in the control group developed DVT, compared to 12 out of 281 patients (4.27%) in the SHCS group. There was significant difference in the incidence of DVT between the two groups (P<0.0001). The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001). No significant difference in plasma D-dimer level was observed between the two groups. No SHCS-related complications occurred in the study.
CONCLUSIONS


This study demonstrate that SHCSs are a satisfactory form of DVT prophylaxis method that can improve venous blood flow and thus alleviate venous stasis in the lower extremities. SHCSs offer a simple, inexpensive, and generally complication-free prophylactic method for lung cancer patients undergoing VATS lobectomy.
TRIAL REGISTRATION


ChiCTR1900022043.",2020,The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001).,"['patients who undergo surgical procedures', '557 participants who underwent', 'lung cancer patients undergoing VATS lobectomy', 'lung cancer patients who undergo video-assisted thoracoscopic surgery lobectomy', 'between June, 2018 and June, 2019']","['SHCSs', 'self-heating calf sleeves (SHCSs', 'video-assisted thoracoscopic surgery (VATS) lobectomy', 'SHCS', 'self-heating calf sleeves']","['Signs and symptoms of DVT', 'deep vein thrombosis', 'plasma D-dimer level', 'Incidences of DVT', 'incidence of DVT', 'SHCS-related complications', 'venous blood flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}]",557.0,0.0169138,The use of SHCSs significantly enhanced venous blood flow compared to when no mechanical prophylaxis was used (P<0.001).,"[{'ForeName': 'Shenghua', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Saiqi', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. zhaoyunfeng518@126.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Operating Room, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. woailuyue0701@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1165']
2373,32921096,"Efficacy and safety of HX 110-A and HX 110-B in promoting respiratory health: protocol for an 8-week, randomized, double-blind, parallel group, placebo-controlled trial.","BACKGROUND


HX110-A and HX110-B are compound extracts based on radix adenophorae and rhizoma dioscoreae, respectively, which have anti-inflammatory activity. There are limited data on whether they may help improve respiratory conditions including lung function. Therefore, in this trial, we will evaluate the effectiveness and safety of the use of HX110-A and HX110-B for the treatment of respiratory health in adults with mild respiratory symptoms.
METHODS


This will be an 8-week, randomized, double-blind, parallel group, placebo-controlled trial with three arms. Adults more than 40 years old with persistent respiratory symptoms will be enrolled. Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents will be excluded. Study subjects will be assigned at a 1:1:1 ratio into the following three arms: controls, experimental group 1 (HX110-A), and experimental group 2 (HX110-B). Control or experimental foods will be administered for 8 weeks, and follow-up will be up to 12 weeks. The primary outcome will be total antioxidant capacity. Secondary outcomes will be inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level. Safety outcomes will be assessed by monitoring adverse events and vital signs, and through clinical pathology tests.
RESULTS


This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms. The results should clarify if active intake of specific foods with these functional compounds may promote respiratory health in adults without definite respiratory disease.
TRIAL REGISTRATION


Clinical Research Information Service, KCT0003614. Registered 12 May 2019 (Respectively registered, https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=13364).",2020,This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms.,"['adults with mild respiratory symptoms', 'Adults more than 40 years old with persistent respiratory symptoms', 'adults without definite respiratory disease', 'adults with respiratory symptoms', 'Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents']","['HX 110-A and HX 110-B', 'HX110-A and HX110-B', 'placebo', 'HX110-A and/or HX110-B']","['Efficacy and safety', 'monitoring adverse events and vital signs, and through clinical pathology tests', 'inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level', 'total antioxidant capacity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0030667', 'cui_str': 'Clinical Pathology'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.58787,This trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms.,"[{'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Bumjo', 'Initials': 'B', 'LastName': 'Oh', 'Affiliation': 'Department of Family Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Seo-Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Tae Yun', 'Initials': 'TY', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Heo', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea.'}, {'ForeName': 'Deog Kyeom', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Republic of Korea. kimdkmd@gmail.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1214']
2374,32921155,Comparative Evaluation of Injection Dexamethasone and Oral Glycerol Versus Injection Dexamethasone Alone in the Treatment of Sudden Onset Sensorineural Deafness.,"OBJECTIVES


Our study was aimed at finding a definitive treatment protocol for the management of sudden sensorineural hearing loss (SSNHL) and to study the prognostic factors affecting it.
METHODS


This randomized clinical study was conducted on a total of 150 patients. All patients older than 10 years and presenting within 15 days of experiencing the symptom of SSNHL and with no known etiology were included. Patients were divided into 2 groups. In group I patients, we administered systemic steroids (injection dexamethasone 3 days, followed by oral deflazacort for 6 days) with liquid glycerol; and in group II, we administered systemic steroids alone (injection dexamethasone 3 days, followed by oral deflazacort for 6 days). The total time for which the treatment was instituted was 9 days and patients were assessed on the basis of their pure tone audiogram and speech discrimination score done at days 0, 3, 7, 21, and 42.
RESULTS


There were 77 males and 73 females. Vertigo ( P  value < .00) and diabetes mellitus ( P  value < .001) had a negative prognostic influence on the recovery rate in both the groups. The comparison revealed that group I (DG) in which patients received injection dexamethasone with oral glycerol had a higher recovery rate of 86.7% as compared to group II (D) patients, in which patients received injection dexamethasone alone (recovery rate = 48%;  P  = .000 highly significant).
CONCLUSIONS


Vertigo and diabetes mellitus play a negative role in the recovery of SSNHL. The novel treatment protocol we used in group I patients that is liquid glycerol and systemic steroids was significantly better and effective in treating SSNHL as compared to the group II treatment protocol of systemic steroids alone. Hence, we concluded that SSNHL is treatable that too with a good recovery rate.",2020,Vertigo ( P  value < .00) and diabetes mellitus ( P  value < .001) had a negative prognostic influence on the recovery rate in both the groups.,"['Sudden Onset Sensorineural Deafness', 'All patients older than 10 years and presenting within 15 days of experiencing the symptom of SSNHL and with no known etiology were included', '150 patients', '77 males and 73 females']","['systemic steroids alone (injection dexamethasone', 'injection dexamethasone', 'injection dexamethasone with oral glycerol', 'liquid glycerol and systemic steroids', 'systemic steroids (injection dexamethasone 3 days, followed by oral deflazacort for 6 days) with liquid glycerol', 'Injection Dexamethasone and Oral Glycerol Versus Injection Dexamethasone']","['total time', 'Vertigo', 'diabetes mellitus', 'recovery rate']","[{'cui': 'C1272517', 'cui_str': 'Sudden onset'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0057258', 'cui_str': 'deflazacort'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",150.0,0.0490625,Vertigo ( P  value < .00) and diabetes mellitus ( P  value < .001) had a negative prognostic influence on the recovery rate in both the groups.,"[{'ForeName': 'Nitika', 'Initials': 'N', 'LastName': 'Mehta', 'Affiliation': 'Department of ENT and Head & Neck Surgery, 75119ASCOMS and Hospital, Jammu and Kashmir, India.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of ENT and Head & Neck Surgery, 75119ASCOMS and Hospital, Jammu and Kashmir, India.'}]","Ear, nose, & throat journal",['10.1177/0145561320952204']
2375,32921196,Attainment of Targets of the 20-Year Infancy-Onset Dietary Intervention and Blood Pressure Across Childhood and Young Adulthood: The Special Turku Coronary Risk Factor Intervention Project (STRIP).,"We examined whether success in achieving the key targets of an infancy-onset 20-year dietary intervention was associated with blood pressure (BP) from infancy to young adulthood. In the prospective randomized STRIP (Special Turku Coronary Risk Factor Intervention Project; n=877 children), dietary counseling was provided biannually based on the Nordic Nutrition Recommendations primarily to improve the quality of dietary fat in children's diets and secondarily to promote intake of vegetables, fruits, and whole grains. Dietary data and BP were accrued annually from the age of 13 months to 20 years. The dietary targets for fat quality were defined as the ratio of saturated fatty acids to monounsaturated and polyunsaturated fatty acids <1:2 and intake of saturated fatty acids <10 E%, dietary fiber intake in the top age-specific quintile, and dietary sucrose intake as being in the lowest age-specific quintile. Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively;  P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3] mm Hg;  P =0.02). When the lowest age-specific quintile of dietary cholesterol was added as an additional target, the association with systolic BP remained significant ( P =0.047), but the association with diastolic BP attenuated ( P =0.13). Achieving the key targets of an infancy-onset 20-year dietary intervention, reflecting dietary guidelines, was favorably albeit modestly associated with systolic and diastolic BP from infancy to young adulthood. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00223600.",2020,"Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively;  P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3",['Across Childhood and Young Adulthood'],"['20-Year Infancy-Onset Dietary Intervention and Blood Pressure', ""dietary counseling was provided biannually based on the Nordic Nutrition Recommendations primarily to improve the quality of dietary fat in children's diets and secondarily to promote intake of vegetables, fruits, and whole grains""]","['systolic and diastolic BP', 'systolic BP', 'blood pressure (BP', 'Dietary data and BP', 'diastolic BP']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0585342', 'cui_str': 'Every other year'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",877.0,0.0185772,"Attaining a higher number of the dietary targets was associated with lower systolic BP (mean [SE] systolic BP, 107.3 [0.3], 107.6 [0.3], 106.8 [0.3], and 106.7 [0.5] mm Hg in participants meeting 0, 1, 2, and 3 to 4 targets, respectively;  P =0.03) and diastolic BP (mean [SE] diastolic BP, 60.4 [0.2], 60.5 [0.2], 59.9 [0.2], and 59.9 [0.3","[{'ForeName': 'Tomi T', 'Initials': 'TT', 'LastName': 'Laitinen', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.).'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Nuotio', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.).'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Niinikoski', 'Affiliation': 'Centre for Population Health Research, Turku University Hospital, University of Turku, Finland (T.T.L., J.N., H.N., S.P.R., C.G.M., H.L., O.T.R., K.P.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Juonala', 'Affiliation': 'Department of Medicine, University of Turku, Finland (M.J., J.S.A.V., T.R.).'}, {'ForeName': 'Suvi P', 'Initials': 'SP', 'LastName': 'Rovio', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.).'}, {'ForeName': 'Jorma S A', 'Initials': 'JSA', 'LastName': 'Viikari', 'Affiliation': 'Department of Medicine, University of Turku, Finland (M.J., J.S.A.V., T.R.).'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku, Finland (M.J., J.S.A.V., T.R.).'}, {'ForeName': 'Costan G', 'Initials': 'CG', 'LastName': 'Magnussen', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.).'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sabin', 'Affiliation': ""Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia (T.T.L., J.N., M.S., D.B.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burgner', 'Affiliation': ""Murdoch Children's Research Institute, The Royal Children's Hospital, Parkville, Victoria, Australia (T.T.L., J.N., M.S., D.B.).""}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Jokinen', 'Affiliation': 'Department of Pediatric Cardiology, Hospital for Children and Adolescents, University of Helsinki, Finland (E.J.).'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lagström', 'Affiliation': 'Centre for Population Health Research, Turku University Hospital, University of Turku, Finland (T.T.L., J.N., H.N., S.P.R., C.G.M., H.L., O.T.R., K.P.).'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jula', 'Affiliation': 'Department of Chronic Disease Prevention, Institute for Health and Welfare, Turku, Finland (A.J.).'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Simell', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital, University of Turku, Finland (H.N., O.S.).'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.).'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pahkala', 'Affiliation': 'From the Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Finland (T.T.L., J.N., S.P.R., C.G.M., O.T.R., K.P.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15075']
2376,32921199,"The effect of teach-back training intervention of breathing exercise on the level of dyspnea, six-minutes walking test and FEV1/FVC ratio in patients with chronic obstructive pulmonary disease; a randomized controlled trial.","BACKGROUND


Chronic obstructive pulmonary disease (COPD) is an irreversible pulmonary obstruction. Respiratory exercise training by a feedback-based model besides the routine managements have been considered to perform.
RESEARCH DESIGN AND METHODS


Eighty exacerbated COPD patients with informed consent were divided to the control group(n=40) received the routine approach and the intervention group(n=40) received a teach-back training method (TBTM)of respiratory exercise including diaphragmatic breathing(DB), pursed-lip breathing(PLB), and effective coughing(EC) plus routine approach. The clinical outcomes were evaluated by measurement of the FEV1/FVC ratio, the Borg scale of dyspnea(BSD), and the 6-minute walking test(6MWT) results at the baseline, just after TBTM, and next three months.
RESULTS


FEV1/FVC ratio has been indicated the significant improvement followed by TBTM compare to the baseline (p<0.001). Moreover, the BSD scores in 3-month follow-up after TBTM were significantly lower compared to the baseline (6 ± 1.3 vs. 3.8 ± 0.78, p<0.001). Although a significant difference was reported in 6MWT distance between two groups after 3-months follow-up(p<0.001), there was no significant difference immediately after the TBTM(p=0.992) that suggested a long-term effect of educational intervention on physical activity.
CONCLUSION


Significant enhancement in the clinical variables can demonstrate the efficacy of the TBTM program in reducing COPD patients' symptoms.
TRIAL REGISTRATION


http//www.irct.ir.Unique identifier: IRCT20181024041449N5.",2020,"Although a significant difference was reported in 6MWT distance between two groups after 3-months follow-up(p<0.001), there was no significant difference immediately after the TBTM(p=0.992) that suggested a long-term effect of educational intervention on physical activity.
","['patients with chronic obstructive pulmonary disease', 'Eighty exacerbated COPD patients with informed consent', 'Chronic obstructive pulmonary disease (COPD']","['educational intervention', 'teach-back training intervention of breathing exercise', 'Respiratory exercise training', 'routine approach and the intervention group(n=40) received a teach-back training method (TBTM)of respiratory exercise including diaphragmatic breathing(DB), pursed-lip breathing(PLB), and effective coughing(EC) plus routine approach', 'FEV1/FVC']","['6MWT distance', 'physical activity', 'level of dyspnea, six-minutes walking test and FEV1/FVC ratio', 'BSD scores', 'FEV1/FVC ratio, the Borg scale of dyspnea(BSD), and the 6-minute walking test(6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429925', 'cui_str': 'Test distance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",80.0,0.0461442,"Although a significant difference was reported in 6MWT distance between two groups after 3-months follow-up(p<0.001), there was no significant difference immediately after the TBTM(p=0.992) that suggested a long-term effect of educational intervention on physical activity.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hasanpour Dehkordi', 'Affiliation': 'Social Determinants of Health Research Center, School of allied medical sciences, Shahrekord University of Medical Sciences , Shahrekord, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Ebrahimi-Dehkordi', 'Affiliation': 'Student Research Committee, Shahrekord University of Medical Sciences , Shahrekord, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Banitalebi-Dehkordi', 'Affiliation': 'Nursing Department, School of Nursing & Midwifery, Shahrekord University of Medical Sciences , Shahrekord, Iran.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Salehi Tali', 'Affiliation': 'Nursing Department, School of Nursing & Midwifery, Shahrekord University of Medical Sciences , Shahrekord, Iran.'}, {'ForeName': 'Soleiman', 'Initials': 'S', 'LastName': 'Kheiri', 'Affiliation': 'Modeling in Health Research Center, Shahrekord University of Medical Sciences , Shahrekord, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Soleimani Babadi', 'Affiliation': 'Medical Faculty, Shahrekord University of Medical Sciences , Shahrekord, Iran.'}]",Expert review of respiratory medicine,['10.1080/17476348.2020.1822740']
2377,32921252,The impact of minimal invasive extracorporeal circulation on postoperative kidney function.,"INTRODUCTION


Acute kidney injury following cardiac surgery is a frequent complication associated with increased mortality and morbidity. Minimal invasive extracorporeal circulation is suggested to preserve postoperative renal function. The aim of this study was to assess the impact of minimal invasive versus conventional extracorporeal circulation on early postoperative kidney function.
METHODS


Randomized controlled trail including 60 patients undergoing elective stand-alone coronary artery bypass graft surgery and allocated in a 1:1 ratio to either minimal invasive (n = 30) or conventional extracorporeal circulation (n = 30). Postoperative kidney injury was assessed by elevation of plasma neutrophil gelatinase-associated lipocalin (NGAL), a sensitive tubular injury biomarker. In addition, we assessed changes in estimated glomerular filtration rate (eGFR), and the incidence of acute kidney injury according to the Acute Kidney Injury Network (AKIN) classification.
RESULTS


We observed no differences between groups regarding increase of plasma NGAL (p = 0.31) or decline of eGFR (p = 0.82). In both groups, 6/30 patients developed acute kidney injury according to the AKIN classification, all regaining preoperative renal function within 30 days.
CONCLUSION


Our findings challenge the superiority of minimal invasive compared to conventional extracorporeal circulation in terms of preservation of renal function following low-risk coronary surgery.",2020,We observed no differences between groups regarding increase of plasma NGAL (p = 0.31) or decline of eGFR (p = 0.82).,"['60 patients undergoing', 'low-risk coronary surgery']","['minimal invasive extracorporeal circulation', 'minimal invasive versus conventional extracorporeal circulation', 'conventional extracorporeal circulation', 'elective stand-alone coronary artery bypass graft surgery and allocated in a 1:1 ratio to either minimal invasive (n\u2009=\u200930) or conventional extracorporeal circulation']","['estimated glomerular filtration rate (eGFR), and the incidence of acute kidney injury according to the Acute Kidney Injury Network (AKIN) classification', 'plasma neutrophil gelatinase-associated lipocalin (NGAL), a sensitive tubular injury biomarker', 'renal function', 'postoperative kidney function', 'Postoperative kidney injury', 'plasma NGAL', 'acute kidney injury', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",60.0,0.0478226,We observed no differences between groups regarding increase of plasma NGAL (p = 0.31) or decline of eGFR (p = 0.82).,"[{'ForeName': 'Ara Shwan', 'Initials': 'AS', 'LastName': 'Media', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Juhl-Olsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nils Erik', 'Initials': 'NE', 'LastName': 'Magnusson', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ivy Susanne', 'Initials': 'IS', 'LastName': 'Modrau', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.'}]",Perfusion,['10.1177/0267659120954601']
2378,32921680,Dapagliflozin Influences Ventricular Hemodynamics and Exercise-Induced Pulmonary Hypertension in Type 2 Diabetes Patients　- A Randomized Controlled Trial.,"BACKGROUND


This prospective randomized multicenter open-label trial evaluated whether sodium-glucose cotransporter-2 inhibitor (SGLT2-i) improves left ventricular (LV) pump function and suppresses elevation of LV filling pressure (LVFP) and right ventricular systolic pressure (RVSP) during exercise in type 2 diabetes mellitus (T2DM) patients.Methods and Results:Based on HbA1c and LV ejection fraction, 78 patients with poorly controlled T2DM were randomly assigned to D-group (dapagliflozin 5 mg/day add-on) or C-group (conventional therapy add-on). Physical examination, home and office blood pressure examination, blood tests, and echocardiography at rest and during ergometer exercise were performed at baseline and at 1.5 and 6 months after treatment. The primary endpoint was defined as the change in RVSP (mmHg) between baseline and 6-month follow up. The secondary endpoints were changes in LVFP (ratio), stroke volume index (SVi; mL/m 2 ), and cardiac index (CI; L/min/m 2 ). Both RVSP and LVFP during exercise significantly decreased from baseline to 6 months after starting treatment in the D-group (P<0.001). No changes to either parameter was observed in the C-group. The SVi and CI did not improve in either group. Both home and office blood pressure significantly decreased in the D-group. Decreases in HbA1c were somewhat greater in the C-group.
CONCLUSIONS


Dapagliflozin significantly improved RVSP and LVFP during exercise in patients with T2DM and cardiovascular risk, which may contribute to favorable effects on heart failure.",2020,Both RVSP and LVFP during exercise significantly decreased from baseline to 6 months after starting treatment in the D-group (P<0.001).,"['patients with T2DM and cardiovascular risk', 'Type 2 Diabetes Patients\u3000', '78 patients with poorly controlled T2DM', 'type 2 diabetes mellitus (T2DM) patients']","['Dapagliflozin Influences Ventricular Hemodynamics and Exercise-Induced Pulmonary Hypertension', 'Dapagliflozin', 'D-group (dapagliflozin 5 mg/day add-on) or C-group (conventional therapy', 'sodium-glucose cotransporter-2 inhibitor (SGLT2-i']","['office blood pressure', 'SVi and CI', 'RVSP and LVFP', 'left ventricular (LV) pump function and suppresses elevation of LV filling pressure (LVFP) and right ventricular systolic pressure (RVSP', 'Physical examination, home and office blood pressure examination, blood tests, and echocardiography at rest and during ergometer exercise', 'Decreases in HbA1c', 'changes in LVFP (ratio), stroke volume index (SVi; mL/m 2 ), and cardiac index (CI; L/min/m 2 ', 'change in RVSP (mmHg']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3709923', 'cui_str': 'dapagliflozin 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0456181', 'cui_str': 'Right ventricular systolic pressure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]",78.0,0.0699834,Both RVSP and LVFP during exercise significantly decreased from baseline to 6 months after starting treatment in the D-group (P<0.001).,"[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kayano', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Koba', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Hirano', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Showa University School of Medicine.'}, {'ForeName': 'Taiju', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Fukuoka', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tsuijita', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Showa University School of Medicine.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Toshida', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Hamazaki', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Geshi', 'Affiliation': 'Department of Internal Medicine, Showa University School of Nursing and Rehabilitation Sciences.'}, {'ForeName': 'Mikitaka', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'Murakami Cardiology and Medical Clinic.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Aihara', 'Affiliation': 'Aihara Medical Clinic.'}, {'ForeName': 'Koujin', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Kaneko Clinic.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Soiken Inc.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Department of Medicine, Division of Cardiology, Showa University School of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0341']
2379,32921794,A single dose of cannabidiol modulates medial temporal and striatal function during fear processing in people at clinical high risk for psychosis.,"Emotional dysregulation and anxiety are common in people at clinical high risk for psychosis (CHR) and are associated with altered neural responses to emotional stimuli in the striatum and medial temporal lobe. Using a randomised, double-blind, parallel-group design, 33 CHR patients were randomised to a single oral dose of CBD (600 mg) or placebo. Healthy controls (n = 19) were studied under identical conditions but did not receive any drug. Participants were scanned with functional magnetic resonance imaging (fMRI) during a fearful face-processing paradigm. Activation related to the CHR state and to the effects of CBD was examined using a region-of-interest approach. During fear processing, CHR participants receiving placebo (n = 15) showed greater activation than controls (n = 19) in the parahippocampal gyrus but less activation in the striatum. Within these regions, activation in the CHR group that received CBD (n = 15) was intermediate between that of the CHR placebo and control groups. These findings suggest that in CHR patients, CBD modulates brain function in regions implicated in psychosis risk and emotion processing. These findings are similar to those previously evident using a memory paradigm, suggesting that the effects of CBD on medial temporal and striatal function may be task independent.",2020,"During fear processing, CHR participants receiving placebo (n = 15) showed greater activation than controls (n = 19) in the parahippocampal gyrus but less activation in the striatum.","['33 CHR patients', 'people at clinical high risk for psychosis', 'Healthy controls (n\u2009=\u200919', 'people at clinical high risk for psychosis (CHR']","['CBD', 'CHR placebo', 'cannabidiol', 'placebo', 'functional magnetic resonance imaging (fMRI']",['Emotional dysregulation and anxiety'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.419389,"During fear processing, CHR participants receiving placebo (n = 15) showed greater activation than controls (n = 19) in the parahippocampal gyrus but less activation in the striatum.","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Appiah-Kusi', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Blest-Hopley', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brammer', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'CAMEO Early Intervention Service, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Murray', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthijs G', 'Initials': 'MG', 'LastName': 'Bossong', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sagnik', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. sagnik.2.bhattacharyya@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-020-0862-2']
2380,32922802,Correction to: Low-chloride- versus high-chloride-containing hypertonic solution for the treatment of subarachnoid hemorrhage-related complications: The ACETatE (A low ChloriE hyperTonic solution for brain Edema) randomized trial.,[This corrects the article DOI: 10.1186/s40560-020-00449-0.].,2020,[This corrects the article DOI: 10.1186/s40560-020-00449-0.].,['subarachnoid hemorrhage-related complications'],['Low-chloride- versus high-chloride-containing hypertonic solution'],[],"[{'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0860861', 'cui_str': 'Cl- decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020554', 'cui_str': 'Hypertonic solutions'}]",[],,0.0584523,[This corrects the article DOI: 10.1186/s40560-020-00449-0.].,"[{'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Sadan', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Singbartl', 'Affiliation': 'Department of Critical Care Medicine, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ 85054 USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Kraft', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Joao McONeil', 'Initials': 'JM', 'LastName': 'Plancher', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander C M', 'Initials': 'ACM', 'LastName': 'Greven', 'Affiliation': 'School of Medicine, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Kandiah', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Cederic', 'Initials': 'C', 'LastName': 'Pimentel', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Papangelou', 'Affiliation': 'Department of Anesthesiology, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Asbury', 'Affiliation': 'Department of Pharmacy, Emory University Hospital, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hanfelt', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Samuels', 'Affiliation': 'Department of Neurology and Neurosurgery, Division of Neurocritical Care, Emory University Hospital and Emory University School of Medicine, 1364 Clifton Rd. NE, Atlanta, GA 30322 USA.'}]",Journal of intensive care,['10.1186/s40560-020-00485-w']
2381,32922827,Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome.,"Background


Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. There is no consensus on optimal treatment strategies for LPHS. Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS. To determine whether catheter-based renal denervation is a meaningful addition to the treatment options in these often-difficult-to-treat LPHS patients, a randomized clinical trial is needed. Prior to conducting a definitive trial that focuses on patient outcomes, ensuring the feasibility of undertaking such a trial is required. As such, we will conduct a single-center randomized control feasibility trial designed to determine viability and provide framework and direction for a larger trial.
Objective


The objective of the study is to determine whether conducting a randomized trial of renal denervation versus sham procedure is feasible in terms of recruitment and eligibility, and adequacy of follow-up in LPHS patients.
Design


Single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial of 10 LPHS patients.
Setting


Regina General Hospital in Regina, Saskatchewan, Canada.
Patients


Ten LPHS patients who require opioid therapy.
Measurements


The main feasibility outcome measures include proportion of target patients who undergo the procedure (treatment or sham) within 6 months; proportion of randomized participants (treatment or control) who entirely complete the follow-up measures at 6 weeks, 3 and 6 months; proportion of the participants who were randomized to control group, cross over after 6 months and opt-in renal denervation treatment; proportion of the crossover participants who complete the follow-up measures at 6 weeks, 3 and 6 months. Pain will be assessed using Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary. Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire, respectively.
Methods


Eligible participants will be randomized into either renal denervation (treatment group) or a sham treatment (control group). Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention. After the initial 6-month follow-up is over, the participants who received the sham procedure will cross over into the treatment group and will be followed for an additional 6 months in the same manner as the treatment group. Descriptive statistics will be used to report outcomes for all patients.
Limitations


Single-center study, small sample size.
Conclusions


The lessons learnt from this trial will lay the framework and direction for conducting a multisite randomized controlled trial involving a larger cohort of patients.
Trial registration


ClinicalTrials.gov (NCT04332731).",2020,"Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention.","['Setting\n\n\nRegina General Hospital in Regina, Saskatchewan, Canada', '10 LPHS patients', 'Patients\n\n\nTen LPHS patients who require opioid therapy', 'LPHS patients', 'Patients With Loin Pain Hematuria Syndrome']","['renal denervation', 'catheter-based renal denervation', 'renal denervation versus sham procedure']","['Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary', 'Pain', 'Data (pain, quality of life, mood, disability', 'Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1208162', 'cui_str': 'Regina'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0036234', 'cui_str': 'Saskatchewan'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0268712', 'cui_str': 'Loin pain-hematuria syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C2732532', 'cui_str': 'Brief pain inventory score'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0451366', 'cui_str': 'Pain diary'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",10.0,0.263525,"Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention.","[{'ForeName': 'Bhanu', 'Initials': 'B', 'LastName': 'Prasad', 'Affiliation': 'Section of Nephrology, Department of Medicine, Regina General Hospital, SK, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Jafari', 'Affiliation': 'Dr. T. Bhanu Prasad Medical Professional Corporation, Regina, SK, Canada.'}, {'ForeName': 'Kaval', 'Initials': 'K', 'LastName': 'Kour', 'Affiliation': 'Dr. T. Bhanu Prasad Medical Professional Corporation, Regina, SK, Canada.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Goyal', 'Affiliation': 'Section of Interventional Radiology, Department of Radiology, Regina General Hospital, SK, Canada.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Garcia', 'Affiliation': 'Section of Urology, Department of Surgery, Cypress Regional Hospital, Swift Current, SK, Canada.'}]",Canadian journal of kidney health and disease,['10.1177/2054358120951390']
2382,32922906,Accuracy of pedicle screw placement in the thoracic and lumbosacral spines using O-arm-based navigation versus conventional freehand technique.,"Background


The accuracy and safety of pedicle screw insertion was markedly improved with the introduction of intraoperative three-dimensional navigation system during the last decade. This study aimed to evaluate the accuracy of pedicle screw placement using O-arm-based navigation system versus conventional freehand technique.
Methods


We reviewed the accuracy of 341 thoracic ( n  = 173) and lumbosacral ( n  = 168) pedicle screws placed in 60 consecutive patients using either O-arm-based navigation or freehand technique in the Department of Neurosurgery of Beijing Tsinghua Changgung Hospital between January 2015 and June 2018. Patient-specific characteristics, treatment-related characteristics, and screw-specific accuracy were analyzed. The accuracy of pedicle screw placement was measured by Gertzbein-Robbins scale and screw grades A and B were clinically acceptable.
Results


One hundred ninety-one screws were inserted in the O-arm-based navigation group and 150 in the freehand group. One hundred eighty-three (95.81%) clinically acceptable screws were placed in the navigation group and 135 (90.00%) in the freehand group ( p  = 0.034). Twenty-three (6.74%) screw revisions were performed in the two groups (8 screws in the navigation group and 15 screws in the freehand group) and significant difference was observed in thoracic spine ( p  = 0.018), while no statistical significance was presented in lumbosacral spine ( p  > 0.05). Twenty-four (12.57%) screws in the navigation group and 24 (16.00%) in the freehand group violated the cortex ( p  > 0.05). Medial screw deviation was the most common problem in the two groups.
Conclusion


The O-arm-based navigation exhibits higher accuracy for pedicle screw insertion than the freehand insertion technique.",2019,"Twenty-three (6.74%) screw revisions were performed in the two groups (8 screws in the navigation group and 15 screws in the freehand group) and significant difference was observed in thoracic spine ( p  = 0.018), while no statistical significance was presented in lumbosacral spine ( p  > 0.05).","['341 thoracic ( n \u2009=\u2009173) and lumbosacral ( n \u2009=\u2009168) pedicle screws placed in 60 consecutive patients using either O-arm-based navigation or freehand technique in the Department of Neurosurgery of Beijing Tsinghua Changgung Hospital between January 2015 and June 2018', 'One hundred ninety-one screws were inserted in the O-arm-based navigation group and 150 in the freehand group']","['pedicle screw placement', 'pedicle screw placement using O-arm-based navigation system versus conventional freehand technique', 'O-arm-based navigation versus conventional freehand technique']","['accuracy of pedicle screw placement', 'thoracic spine', 'Medial screw deviation', 'Gertzbein-Robbins scale and screw grades', 'screw revisions', 'lumbosacral spine', 'accuracy and safety of pedicle screw insertion']","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0223603', 'cui_str': 'Structure of lumbosacral vertebrae'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",191.0,0.0313213,"Twenty-three (6.74%) screw revisions were performed in the two groups (8 screws in the navigation group and 15 screws in the freehand group) and significant difference was observed in thoracic spine ( p  = 0.018), while no statistical significance was presented in lumbosacral spine ( p  > 0.05).","[{'ForeName': 'Linkai', 'Initials': 'L', 'LastName': 'Jing', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084 China.'}, {'ForeName': 'Zhenze', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Haicheng Zhenggu Hospital, Anshan City, 114200 Liaoning China.'}, {'ForeName': 'Zhenxing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084 China.'}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084 China.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084 China.'}, {'ForeName': 'Guihuai', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'School of Clinical Medicine, Tsinghua University, Beijing, 100084 China.'}]",Chinese neurosurgical journal,['10.1186/s41016-019-0154-y']
2383,32928792,Efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in patients with insufficiently controlled type 2 diabetes: results of the phase IV COBALTA trial.,"INTRODUCTION


This study assessed the efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in insufficiently controlled people with type 2 diabetes.
RESEARCH DESIGN AND METHODS


COBALTA (for its acronym in Spanish, COntrol Basal durante la hospitalizacion y al ALTA) was a multicenter, open-label, single-arm, phase IV trial including 112 evaluable inpatients with type 2 diabetes insufficiently controlled (glycosylated hemoglobin (HbA1c) 8%-10%) with basal insulin and/or non-insulin antidiabetic drugs. Patients were treated with a basal-bolus-correction insulin regimen with Gla-300 during the hospitalization and with Gla-300 and/or non-insulin antidiabetics for 6 months after discharge. The primary endpoint was the HbA1c change from baseline to month 6 postdischarge.
RESULTS


HbA1c levels decreased from 8.8%±0.6% at baseline to 7.2%±1.1% at month 6 postdischarge (p<0.001, mean change 1.6%±1.1%). All 7-point blood glucose levels decreased from baseline to 24 hours predischarge (p≤0.001, mean changes from 25.1±66.6 to 63.0±85.4 mg/dL). Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively). Satisfaction was high and hyperglycemia/hypoglycemia perception was low according to the Diabetes Treatment Satisfaction Questionnaire at month 6 postdischarge. The incidence of confirmed (glucose<70 mg/dL)/severe hypoglycemia was 25.0% during hospitalization and 59.1% 6 months after discharge. No safety concerns were reported.
CONCLUSIONS


Inpatient and intensification therapy at discharge with Gla-300 improved significantly glycemic control of patients with type 2 diabetes insufficiently controlled with other basal insulin and/or non-insulin antidiabetic medication, with high treatment satisfaction. Gla-300 could therefore be a treatment choice for hospital and postdischarge diabetes management.",2020,"Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively).","['COBALTA (for its acronym in Spanish', '112 evaluable inpatients with type', 'patients with type 2 diabetes', 'patients with insufficiently controlled type 2 diabetes']","['basal insulin and/or non-insulin antidiabetic drugs', 'basal-bolus-correction insulin regimen with Gla-300 during the hospitalization and with Gla-300 and/or non-insulin antidiabetics', 'U/mL (Gla-300', 'insulin glargine 300 U/mL (Gla-300', 'insulin glargine 300', 'Gla-300']","['glycemic control', 'All 7-point blood glucose levels', 'efficacy and safety', 'Satisfaction was high and hyperglycemia/hypoglycemia perception', 'Efficacy and safety', 'HbA1c levels', 'HbA1c change from baseline to month 6 postdischarge', 'Fasting plasma glucose', 'incidence of confirmed (glucose<70\u2009mg/dL)/severe hypoglycemia']","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]",112.0,0.0286274,"Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital de la Santa Creu i Sant Pau, CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Universitat Autònoma de Barcelona, Barcelona, Spain aperez@santpau.cat.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Carrasco-Sánchez', 'Affiliation': 'Department of Internal Medicine, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'González', 'Affiliation': 'Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Seguí-Ripoll', 'Affiliation': ""Department of Internal Medicine, Hospital Universitario San Joan d'Alacant, Sant Joan d'Alacant, Spain.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Trescolí', 'Affiliation': 'Department of Internal Medicine, Hospital Universitario de La Ribera, Alzira, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ena', 'Affiliation': 'Department of Internal Medicine, Hospital Marina Baixa, Villajoyosa, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Borrell', 'Affiliation': 'Medical Department, Sanofi, Barcelona, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gomez Huelgas', 'Affiliation': 'Department of Internal Medicine, Hospital Regional Universitario de Málaga, Málaga, Instituto de Investigación Biomédica de Málaga, Universidad de Málaga; CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001518']
2384,32928796,"Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase 3, Randomized, Open-label, Multi-center FESTnd Study.","PURPOSE


Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib. We evaluated the efficacy and safety of flumatinib versus imatinib, for first-line treatment of chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CML-CP).
EXPERIMENTAL DESIGN


In this study, 394 patients were randomized 1:1 to flumatinib 600 mg once daily (n=196) or imatinib 400 mg once daily (n=198).
RESULTS


The rate of major molecular response (MMR) at 6 months (primary end point) was significantly higher with flumatinib than with imatinib (33.7% vs 18.3%, P=0.0006), as was the rate of MMR at 12 months (52.6% vs 39.6%, P=0.0102). At 3 months, the rate of early molecular response (EMR) was significantly higher in patients receiving flumatinib than in those receiving imatinib (82.1% vs 53.3%, P<0.0001). Compared with patients receiving imatinib, more patients receiving flumatinib achieved MR4 at 6, 9 and 12 months (8.7% vs 3.6%, P=0.0358; 16.8% vs 5.1%, P=0.0002; 23.0% vs 11.7%, P=0.0034, respectively). No patients had progression to accelerated phase or blast crisis in the flumatinib arm versus 4 patients in the imatinib arm by 12 months. Adverse events of edema, pain in extremities, rash, neutropenia, anemia, and hypophosphatemia were more frequent in imatinib arm, whereas diarrhea and alanine transaminase elevation were more frequent in flumatinib arm.
CONCLUSIONS


Patients receiving flumatinib achieved significantly higher rates of responses, faster and deeper responses compared with those receiving imatinib, indicating that flumatinib can be an effective first-line treatment for CML-CP. This trial was registered at www.clinicaltrials.gov as NCT02204644.",2020,"At 3 months, the rate of early molecular response (EMR) was significantly higher in patients receiving flumatinib than in those receiving imatinib (82.1% vs 53.3%, P<0.0001).","['Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia', 'chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CML-CP', '394 patients']","['flumatinib versus imatinib', 'Flumatinib versus Imatinib', 'flumatinib 600 mg once daily (n=196) or imatinib 400 mg once daily (n=198']","['MR4', 'efficacy and safety', 'rates of responses, faster and deeper responses', 'ABL1 tyrosine kinase', 'rate of major molecular response (MMR', 'Adverse events of edema, pain in extremities, rash, neutropenia, anemia, and hypophosphatemia', 'progression to accelerated phase or blast crisis', 'diarrhea and alanine transaminase elevation', 'rate of early molecular response (EMR', 'rate of MMR']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023474', 'cui_str': 'Chronic phase chronic myeloid leukemia'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0279543', 'cui_str': 'Philadelphia chromosome positive chronic myelogenous leukemia'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1331284', 'cui_str': 'imatinib 400 MG'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0033681', 'cui_str': 'Protein-tyrosine kinase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0457345', 'cui_str': 'Accelerated phase'}, {'cui': 'C0005699', 'cui_str': 'Blast crisis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",394.0,0.0563832,"At 3 months, the rate of early molecular response (EMR) was significantly higher in patients receiving flumatinib than in those receiving imatinib (82.1% vs 53.3%, P<0.0001).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Tongji Hospital Tongji Medical College of Huazhong University of Science &Technology, Wuhan.'}, {'ForeName': 'Bingcheng', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Henan Cancer Hospital, Zhengzhou.'}, {'ForeName': 'Huanling', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'The West China College of Medicine, Sichuan University, Chengdu.'}, {'ForeName': 'Jiuwei', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Cancer center, First Hospital of Jilin University.'}, {'ForeName': 'Aining', 'Initials': 'A', 'LastName': 'Sun', 'Affiliation': 'Hematology, First Affiliated Hospital of Soochow University.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Institution of Hematology.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Peking University Institute of Hematology, Peking University People's Hospital.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, Xinqiao Hospital, The Third Military Medical University.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Hospital of China Medical University, Shenyang.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Hematology, Tangdu Hospital, Fourth Military Medical University.'}, {'ForeName': 'Wanggang', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an.""}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Clinical Medical College of Yangzhou University/Yangzhou Institute of Hematology, Yangzhou.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': ""The 307th Hospital of Military Chinese People's Liberation Army, Beijing.""}, {'ForeName': 'Guifang', 'Initials': 'G', 'LastName': 'Ouyang', 'Affiliation': 'Ningbo Universtiy.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'AnHui Provincial Hospital, Hefei.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'The Second Hospital of Hebei Medical University, Key Laboratory of Hematology.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi.'}, {'ForeName': 'Xiaobao', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""The First People's Hospital of Changzhou, Changzhou.""}, {'ForeName': 'Jianyong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Nanjing Medical University.'}, {'ForeName': 'Chunting', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'The Affiliated Hospital of Qingdao University, Qingdao.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, the First Affiliated Hospital of Medical College, Xi'an Jiaotong University.""}, {'ForeName': 'Tonghua', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': ""The First People's Hospital of Yunnan Province, Kunming.""}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Disease, Leukaemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences wangjx@ihcams.ac.cn.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1600']
2385,32928798,"Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India.","BACKGROUND


Evidence-based practices that reduce childbirth-related morbidity and mortality are core processes to quality of care. In the BetterBirth trial, a matched-pair, cluster-randomised controlled trial of a coaching-based implementation of the WHO Safe Childbirth Checklist (SCC) in Uttar Pradesh, India, we observed a significant increase in adherence to practices, but no reduction in perinatal mortality.
METHODS


Within the BetterBirth trial, we observed birth attendants in a subset of study sites providing care to labouring women to assess the adherence to individual and groups of practices. We observed care from admission to the facility until 1 hour post partum. We followed observed women/newborns for 7-day perinatal health outcomes. Using this observational data, we conducted a post-hoc, exploratory analysis to understand the relationship of birth attendants' practice adherence to perinatal mortality.
FINDINGS


Across 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes. Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%). We recorded 166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths. Each additional practice performed was significantly associated with reduced odds of perinatal (OR: 0·82, 95% CI: 0·72, 0·93) and early neonatal mortality (OR: 0·78, 95% CI: 0·71, 0·85). Each additional practice as part of direct provider care was associated strongly with reduced odds of perinatal (OR: 0·73, 95% CI: 0·62, 0·86) and early neonatal mortality (OR: 0·67, 95% CI: 0·56, 0·80). No individual practice or single supply preparation was associated with perinatal mortality.
INTERPRETATION


Adherence to practices on the WHO SCC is associated with reduced mortality, indicating that adherence is a valid indicator of higher quality of care. However, the causal relationships between practices and outcomes are complex.
FUNDING


Bill & Melinda Gates Foundation.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.",2020,"Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%).","['Within the BetterBirth trial', 'Across 30 primary health facilities, we observed 3274 deliveries and obtained 7-day health outcomes', '166 perinatal deaths (50·71 per 1000 births), including 56 (17·1 per 1000) stillbirths', '3,274 births in Uttar Pradesh, India']",['coaching-based implementation of the WHO Safe Childbirth Checklist (SCC'],"['early neonatal mortality', 'perinatal mortality', 'early neonatal mortality ']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]","[{'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}]",,0.256585,"Adherence to individual practices, containing supply preparation and direct provider care, varied widely (0·51 to 99·78%).","[{'ForeName': 'Katherine Ea', 'Initials': 'KE', 'LastName': 'Semrau', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA ksemrau@ariadnelabs.org.""}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fisher-Bowman', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Karlage', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Krasne', 'Affiliation': 'Department of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Gass', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jurczak', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Pratap Singh', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Shambhavi', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Marx Delaney', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Hirschhorn', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Bhalachandra', 'Initials': 'B', 'LastName': 'Kodkany', 'Affiliation': 'Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Community Empowerment Lab, Lucknow, India.'}, {'ForeName': 'Atul A', 'Initials': 'AA', 'LastName': 'Gawande', 'Affiliation': ""Ariadne Labs at Brigham and Women's Hospital and Harvard TH Chan School of Public Health, Boston, Massachusetts, USA.""}]",BMJ global health,['10.1136/bmjgh-2019-002268']
2386,32921117,A clinical study of preoperative carbohydrate administration to improve insulin resistance in patients with multiple injuries.,"BACKGROUND


The purpose of this study was to investigate the tolerance and safety of carbohydrate administration to patients with multiple injuries prior to surgery, and to analyze the effects of carbohydrate intake on their immediate insulin resistance (IR), postoperative complications, and length of hospital stay.
METHODS


A total of 125 patients with mild multiple injuries who were admitted to the Emergency Surgery Department of Affiliated Hospital of Nantong University for elective surgery were randomized to administration of either placebo or carbohydrate. Finally, 82 patients (male: 39, female: 43) successfully completed the experiment and collected data. Preoperative general condition, subjective comfort, blood glucose concentration, serum insulin and insulin resistance index (IR) were studied.
RESULTS


The two groups of patients matched in gender, age, body mass index (BMI) (P>0.05). Patients in CHO group treated with carbohydrates three hours before surgery compared with patients treated with preoperative specification. The thirst, hunger and anxiety of the patients in the CHO group were significantly relieved (P<0.05). Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
CONCLUSIONS


It is a relatively safe approach that patients took carbohydrates 3 hours before surgery, and there was no statistically significant difference in the incidence of postoperative aspiration. Taking carbohydrates before surgery can not only relieve preoperative discomfort, but also reduce postoperative insulin resistance, which is helpful to avoid postoperative metabolic disorder and speed up recovery.",2020,"Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
","['82 patients (male: 39, female: 43) successfully completed the experiment and collected data', '125 patients with mild multiple injuries who were admitted to the Emergency Surgery Department of Affiliated Hospital of Nantong University for elective surgery', 'patients with multiple injuries', 'patients with multiple injuries prior to surgery']","['carbohydrates', 'carbohydrate', 'preoperative carbohydrate administration', 'placebo or carbohydrate']","['Blood glucose concentration, serum insulin, and IR', 'immediate insulin resistance (IR), postoperative complications, and length of hospital stay', 'incidence of postoperative aspiration', 'insulin resistance', 'hunger and anxiety', 'Preoperative general condition, subjective comfort, blood glucose concentration, serum insulin and insulin resistance index (IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",125.0,0.0245766,"Blood glucose concentration, serum insulin, and IR were much lower in the CHO group (P<0.05).
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Guomin', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Guiwen', 'Initials': 'G', 'LastName': 'Liang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China. jhy@ntu.edu.cn.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Emergency Medicine, Affiliated Hospital of Nantong University, Nantong, China. tdfyhuangzw@163.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1424']
2387,32921123,Effects of tai chi on catheter management and quality of life in tumor patients with PICC at the intermission of chemotherapy: a non-inferiority randomized controlled trial.,"BACKGROUND


Peripherally inserted central catheter (PICC) is widely used in chemotherapy due to its minimal complications and simple wound care. This study explored the effects of tai chi on catheterrelated complications, catheter management ability, and quality of life in tumor patients with PICC at the intermission of chemotherapy.
METHODS


This study was an open parallel trial. A total of 98 patients with malignant tumors who underwent long-term chemotherapy with PICC were randomly divided into an observation group (49 cases) and a control group (49 cases). The control group received grip strength exercise for 3 months, while the observation group received 24 simplified tai chi exercises. The coagulation function, thrombosis rate, self-management ability, and quality of life were compared between the two groups before and after the intervention.
RESULTS


After the intervention, the activated partial thromboplastin time (APTT) and prothrombin time (PT) in the observation group were longer than those in the control group, while fibrinogen (FIB) was lower than that in the control group (all P<0.05). After the intervention, the total score of self-management ability of the observation group was higher than that of the control group (t=2.038, P=0.047), and the scores of exercises ability and quality of daily life with catheters were significantly increased (all P<0.05). In terms of quality of life, scores of role-physical (RP), social functioning (SF), mental health (MH) and role-emotional (RE) in the observation group were higher than those in the control group (all P<0.05), while there was no statistical difference between the bodily pain (BP) scores of the observation group and the control group (P>0.05). The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
CONCLUSIONS


Tai chi can prevent PICC thrombosis, reduce PICC-related complications, improve selfmanagement ability, and improve quality of life in at-home patients with long-term PICC.",2020,"The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
","['98 patients with malignant tumors who underwent long-term chemotherapy with PICC', 'tumor patients with PICC at the intermission of chemotherapy']","['grip strength exercise', '24 simplified tai chi exercises', 'tai chi', 'Peripherally inserted central catheter (PICC']","['incidence of venous thrombosis', 'coagulation function, thrombosis rate, self-management ability, and quality of life', 'fibrinogen (FIB', 'scores of exercises ability and quality of daily life with catheters', 'catheter management and quality of life', 'quality of life, scores of role-physical (RP), social functioning (SF), mental health (MH) and role-emotional (RE', 'total score of self-management ability', 'bodily pain (BP) scores', 'activated partial thromboplastin time (APTT) and prothrombin time (PT', 'catheterrelated complications, catheter management ability, and quality of life', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0280440', 'cui_str': 'Catheter management'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",98.0,0.0311705,"The incidence of venous thrombosis in the observation group was lower than that in the control group, the difference was statistically significant ( χ 2 =4.439, P=0.035).
","[{'ForeName': 'Yuehua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Department of PICC clinic, Hai'an People's Hospital, Hai'an, China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Breast and Thyroid Surgery, Jiangyin People's Hospital, Jiangyin, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Oncology, the Second People's Hospital of Wuxi, Wuxi, China. huyue20193@163.com.""}]",Annals of palliative medicine,['10.21037/apm-20-1456']
2388,32921136,The Effect of Nasoseptal Flap Elevation on Post-Operative Olfaction and Sinonasal Quality of Life: A Prospective Double-Blinded Randomized Controlled Trial.,"BACKGROUND


The use of nasoseptal flaps (NSF) for defect reconstruction in endoscopic endonasal approaches (EEA) to cranial base pathology has markedly reduced rates of cerebrospinal fluid leak. However, the effect of NSF use on post-operative olfaction remains unclear.
OBJECTIVE


To evaluate the impact of NSF use during EEA on binarial and uninarial olfaction, and sinonasal quality of life (QOL).
METHODS


This was a prospective double-blinded randomized controlled trial. Patients undergoing EEA for sellar pathology were recruited from the University of Pittsburgh Medical Center from December 2014 to May 2017. Subjects were randomized pre-operatively to a side of NSF harvest. Olfaction and QOL were assessed pre-operatively and 6 to 12 months post-operatively using the University of Pennsylvania Smell Identification Test, ""Sniffin' Sticks,"" and Sinonasal Outcomes Test 22. The side of dominant uninarial olfaction was determined using ""Sniffin' Sticks.""
RESULTS


Thirty-one patients were enrolled. Sixteen underwent EEA without NSF (control group) and 15 with NSF. A dominant side of olfaction was identified in 14 patients with NSF; 8 patients were randomized to NSF harvest on the dominant side and the remaining 6 on the non-dominant side. NSF elevation resulted in a 4% decrease in University of Pennsylvania Smell Identification Test scores, but was not statistically significant compared to controls. Similarly, NSF elevation on the side of dominant olfaction resulted in a 6% decrease, but was not statistically significant when compared to the non-dominant elevation group. Change in rhinologic QOL as determined by the Sinonasal Outcomes Test 22 was not significantly different between any of the groups.
CONCLUSIONS


The use of NSF during EEA for sellar pathology does not have a significant effect on olfaction or rhinologic QOL. The presence of a dominant side of olfaction is not a primary consideration when deciding the side of NSF harvest.",2020,"NSF elevation resulted in a 4% decrease in University of Pennsylvania Smell Identification Test scores, but was not statistically significant compared to controls.","['Patients undergoing EEA for sellar pathology were recruited from the University of Pittsburgh Medical Center from December 2014 to May 2017', '14 patients with NSF; 8 patients', 'Thirty-one patients were enrolled']","['Nasoseptal Flap Elevation', 'nasoseptal flaps (NSF', 'NSF', 'EEA without NSF (control group) and 15 with NSF']","['binarial and uninarial olfaction, and sinonasal quality of life (QOL', 'Post-Operative Olfaction and Sinonasal Quality of Life', 'rhinologic QOL', 'NSF elevation on the side of dominant olfaction', 'olfaction or rhinologic QOL', 'NSF elevation', 'University of Pennsylvania Smell Identification Test scores', 'Olfaction and QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0225425', 'cui_str': 'Internal nose structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0225425', 'cui_str': 'Internal nose structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",31.0,0.107192,"NSF elevation resulted in a 4% decrease in University of Pennsylvania Smell Identification Test scores, but was not statistically significant compared to controls.","[{'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Chou', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Stanford University, Stanford, California.'}, {'ForeName': 'Benita', 'Initials': 'B', 'LastName': 'Valappil', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Mattos', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Carl H', 'Initials': 'CH', 'LastName': 'Snyderman', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gardner', 'Affiliation': 'Department of Neurosurgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Fernandez-Miranda', 'Affiliation': 'Department of Neurosurgery, Stanford University, Stanford, California.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",American journal of rhinology & allergy,['10.1177/1945892420957505']
2389,32921501,"Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia: A Randomized, Open-Labeled, Multicentered, Phase IV Study.","PURPOSE


Although the role of high-intensity lipid-lowering therapy in cardiovascular protection has broadened, concerns still exist about new-onset diabetes mellitus (NODM), especially in vulnerable patients. This study aimed to compare the effect of high-dose (4 mg/d) and usual dose (2 mg/d) pitavastatin on glucose metabolism in patients with hyperlipidemia and impaired fasting glucose (IFG).
METHODS


In this 12-month study, glucose tolerance and lipid-lowering efficacy of high-dose pitavastatin (4 mg [study group]) was compared with that of usual dose pitavastatin (2 mg [control group]) in patients with hyperlipidemia and IFG. The primary end point was the change of glycosylated hemoglobin (HbA 1c ) after 24 weeks of treatment. The secondary end points were as follows: (1) NODM within 1 year after treatment, (2) change of lipid parameters, (3) changes of adiponectin, and (4) change of blood glucose and insulin levels.
FINDINGS


Of the total 417 patients screened, 313 patients with hypercholesterolemia and IFG were randomly assigned into groups. The mean (SD) change in HbA 1c  was 0.06% (0.20%) in the study group and 0.03% (0.22%) in the control group (P = 0.27). Within 1 year, 27 patients (12.3%) developed NODM, including 12 (10.6%) of 113 patients in the study group and 15 (14.2%) of 106 in the control group (P = 0.43). The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01).
IMPLICATIONS


The high-dose pitavastatin therapy did not aggravate glucose metabolism compared with the usual dose therapy. Moreover, it had a better effect on cholesterol-lowering and apolipoprotein distribution in the patients with hyperlipidemia and IFG.",2020,"The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01).
","['Of the total 417 patients screened, 313 patients with hypercholesterolemia and IFG', 'Patients With Impaired Fasting Glucose and Hyperlipidemia', 'patients with hyperlipidemia and impaired fasting glucose (IFG', 'patients with hyperlipidemia and IFG']","['high-intensity lipid-lowering therapy', 'high-dose pitavastatin', 'pitavastatin', 'pitavastatin therapy', 'high-dose (4\xa0mg/d) and usual dose (2\xa0mg/d) pitavastatin', 'Pitavastatin']","['glucose tolerance and lipid-lowering efficacy', 'aggravate glucose metabolism', 'Safety and Efficacy', 'lipid parameters, (3) changes of adiponectin, and (4) change of blood glucose and insulin levels', 'mean (SD) change in HbA 1c', 'glucose metabolism', 'apolipoprotein A1/apolipoprotein B ratio', 'change of glycosylated hemoglobin (HbA 1c ', 'total cholesterol and LDL-C levels', 'cholesterol-lowering and apolipoprotein distribution', 'NODM']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",313.0,0.0185979,"The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01).
","[{'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ki-Hoon', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Woo-Baek', 'Initials': 'WB', 'LastName': 'Chung', 'Affiliation': ""Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Her', 'Affiliation': ""Daejeon St. Mary's Hospital, Daejeon, South Korea.""}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Dong-A University Hospital, Busan, South Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Suwan, South Korea.'}, {'ForeName': 'Kyung-Tae', 'Initials': 'KT', 'LastName': 'Jung', 'Affiliation': 'Eulji University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Jong-Seon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Yeungnam University Hospital, Daegu, South Korea.'}, {'ForeName': 'Pum-Joon', 'Initials': 'PJ', 'LastName': 'Kim', 'Affiliation': ""St. Mary's Hospital Eunpyeong, Seoul, South Korea.""}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""St. Mary's Hospital Uijeongbu, Seoul, South Korea.""}, {'ForeName': 'Myung-Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Ulsan University Hospital, Ulsan, South Korea.'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Kyoo-Rok', 'Initials': 'KR', 'LastName': 'Han', 'Affiliation': 'Kangdong Sacred Heart Hospital, Gangdong-gu, South Korea.'}, {'ForeName': 'Jei-Keon', 'Initials': 'JK', 'LastName': 'Chae', 'Affiliation': 'Chonbuk National University Hospital, Jeollabuk-do, South Korea.'}, {'ForeName': 'Woo-Shik', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Kyung Hee University Hospital, Gangdong, South Korea.'}, {'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul, South Korea.'}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Si-Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Namsik', 'Initials': 'N', 'LastName': 'Chung', 'Affiliation': 'Yonsei University Severance Hospital, Seoul, South Korea. Electronic address: namsikc@yuhs.ac.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.013']
2390,32921503,Reduced mortality risk in malnourished hospitalized older adult patients with COPD treated with a specialized oral nutritional supplement: Sub-group analysis of the NOURISH study.,"BACKGROUND


Hospitalized, malnourished older adults with chronic obstructive pulmonary disease (COPD) have an elevated risk of readmission and mortality.
OBJECTIVE


Post-hoc, sub-group analysis from the NOURISH study cohort examined the effect of a high-protein oral nutritional supplement (ONS) containing HMB (HP-HMB) in malnourished, hospitalized older adults with COPD and to identify predictors of outcomes.
METHODS


The NOURISH study (n = 652) was a multicenter, randomized, placebo-controlled, double-blind trial. The COPD subgroup (n = 214) included hospitalized, malnourished (based on Subjective Global Assessment), older adults (≥65 y), with admission diagnosis of COPD who received either standard-of-care plus HP-HMB (n = 109) or standard-of-care and a placebo supplement (n = 105) prescribed 2 servings/day from within 3 days of hospital admission (baseline) and up to 90 days after discharge. The primary study outcome was a composite endpoint of incidence of death or non-elective readmission up to 90-day post-discharge, while secondary endpoints included changes in hand-grip strength, body weight, and nutritional biomarkers over time. Categorical outcomes were analyzed using Cochran-Mantel-Haenszel tests, longitudinal data by repeated measures analysis of covariance; and changes from baseline by analysis of covariance. p-values ≤ 0.05 were considered statistically significant. Multivariate logistic regression was used to model predictors of the primary outcome and components.
RESULTS


In patients with COPD, 30, 60, and 90-day hospital readmission rate did not differ, but in contrast, 30, 60, and 90-day mortality risk was approximately 71% lower with HP-HMB supplementation relative to placebo (1.83%, 2.75%, 2.75% vs. 6.67%, 9.52% and 10.48%, p = 0.0395, 0.0193, 0.0113, resp.). In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. -0.01 kg, p < 0.05) and, improvements in blood nutritional biomarker concentrations. The multivariate logistic regression predictors of the death, readmission or composite endpoints in these COPD patients showed that participants who were severely malnourished (p = 0.0191) and had a GPS Score of 1 or 2 had statistically significant odds of readmission or death (p = 0.0227).
CONCLUSIONS


Among malnourished, hospitalized patients with COPD, supplementation with HP-HMB was associated with a markedly decreased mortality risk, and improved handgrip strength, body weight, and nutritional biomarkers within a 90-day period after hospital discharge. This post-hoc, subgroup analysis highlights the importance of early identification of nutritional risk and administration of high-protein ONS in older, malnourished patients with COPD after hospital admission and continuing after hospital discharge.",2020,"In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. ","['COPD subgroup (n\xa0=\xa0214) included hospitalized, malnourished (based on Subjective Global Assessment), older adults (≥65\xa0y), with admission diagnosis of COPD who received either', 'malnourished, hospitalized older adults with COPD', 'older, malnourished patients with COPD after hospital admission and continuing after hospital discharge', 'malnourished hospitalized older adult patients with COPD', 'malnourished, hospitalized patients with COPD, supplementation with HP-HMB', 'Hospitalized, malnourished older adults with chronic obstructive pulmonary disease (COPD']","['high-protein oral nutritional supplement (ONS) containing HMB (HP-HMB', 'placebo', 'standard-of-care plus HP-HMB (n\xa0=\xa0109) or standard-of-care and a placebo supplement']","['mortality risk', 'composite endpoint of incidence of death or non-elective readmission up to 90-day post-discharge, while secondary endpoints included changes in hand-grip strength, body weight, and nutritional biomarkers over time', 'hospital discharge', '90-day hospital readmission rate', 'GPS Score', 'handgrip strength', 'readmission or death', '90-day mortality risk', 'body weight', 'death, readmission or composite endpoints', 'mortality risk, and improved handgrip strength, body weight, and nutritional biomarkers', 'blood nutritional biomarker concentrations']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.272438,"In patients with COPD, compared to placebo, intake of HP-HMB resulted in a significant increase in handgrip strength (+1.56 kg vs. -0.34 kg, p = 0.0413) from discharge to day 30; increased body weight from baseline to hospital discharge (0.66 kg vs. ","[{'ForeName': 'Nicolaas E', 'Initials': 'NE', 'LastName': 'Deutz', 'Affiliation': 'Texas A&M University, College Station, TX, USA. Electronic address: nep.deutz@ctral.org.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Ziegler', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Matheson', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Matarese', 'Affiliation': 'Brody School of Medicine at East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Tappenden', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Geraldine E', 'Initials': 'GE', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Nelson', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Refaat', 'Initials': 'R', 'LastName': 'Hegazi', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Satya S', 'Initials': 'SS', 'LastName': 'Jonnalagadda', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.031']
2391,32921505,Using a patient prompt list to raise concerns in oncology clinics does not necessarily lead to longer consultations.,"Head and neck oncology post-treatment consultations form a critical component of care in terms of support and surveillance. They occur frequently in the first few years and can place substantial demands on healthcare resources. However, they provide useful opportunities for patients to raise issues and receive tailored information and support. The aim of this paper was to assess whether completion of a 56-item patient prompt list (PCI - the Patient Concerns Inventory) immediately prior to the consultation significantly increased its duration. This was a pragmatic cluster preference randomised controlled trial of 288 patients with 15 consultant clusters from two sites ""using"" (n=8) or ""not using"" (n=7) the PCI. Consultation times were known for 283 patients (136 PCI, 147 non-PCI) who attended their first post-treatment trial consultation a median (IQR) of 103 (70-160) days after the end of treatment. Consultations lasted a median (IQR) of 10 (7-13) minutes (mean 11) in non-PCI patients and a median (IQR) of 11 (8-15) minutes (mean 12) in PCI patients (p=0.07). After adjustment for patient clustering and significant case mix, the 95% confidence interval for the mean difference was between 1.45minutes shorter with the PCI and 2.98minutes longer (p=0.50). There was significant variation in duration by consultant, tumour stage, treatment mode, overall quality of life (QoL), and distress (all p<0.001). In those who completed the PCI, duration increased with the total number of items selected (p<0.001). In conclusion, the inclusion of a prompt list to help facilitate conversation with patients did not make a substantial difference to consultation times.",2020,"In those who completed the PCI, duration increased with the total number of items selected (p<0.001).","['288 patients with 15 consultant clusters from two sites ""using"" (n=8) or ""not using"" (n=7) the PCI']",[],"['duration by consultant, tumour stage, treatment mode, overall quality of life (QoL), and distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",288.0,0.148831,"In those who completed the PCI, duration increased with the total number of items selected (p<0.001).","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Faculty of Health and Social Care, Edge Hill University, Ormskirk, L39 4QP; Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK. Electronic address: SIMONN.ROGERS@liverpoolft.nhs.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Semple', 'Affiliation': 'Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co. Antrim, BT37 0QB; South Eastern Health & Social Care, Upper Newtownards Road, Belfast, BT16 1RH. Electronic address: cherith.semple@setrust.hscni.net.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': 'School of Medicine, Medical & Biological Sciences, North Haugh, St Andrews, UK. Electronic address: gmh4@st-andrews.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Astraglobe Ltd., Congleton, Cheshire. Electronic address: astraglobeltd@btconnect.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanatas', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK. Electronic address: anastasios.kanatas@nhs.net.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.08.035']
2392,32921508,Effects of auricular acupressure on depression and anxiety in older adult residents of long-term care institutions: A randomized clinical trial.,"The current study was a single-blind clinical trial that evaluated the effect of auricular acupressure on older adults' depression and anxiety. Forty-seven older adults in long-term care institutions were randomly divided into two groups using block randomization. In the experimental group, patches with magnetic beads were pasted onto the auricular Shenmen acupoints for 14 days. In the control group, blank patches were used. Among the older adults in the study institutions, 82.09% scored ≥5 points on the Geriatric Depression Scale (GDS). Significant differences in GDS scores were observed between the two groups after both 7 and 14 days of treatment (p < 0.05). There was no significant difference (p < 0.05) in anxiety scores between the two groups at 7 days, but there was a significant difference after 14 days of the intervention (p < 0.05). Our results suggest that acupressure can reduce depression and anxiety among older adults in long-term care institutions.",2020,"There was no significant difference (p < 0.05) in anxiety scores between the two groups at 7 days, but there was a significant difference after 14 days of the intervention (p < 0.05).","['Forty-seven older adults in long-term care institutions', ""older adults' depression and anxiety"", 'older adult residents of long-term care institutions']","['acupressure', 'auricular acupressure']","['Geriatric Depression Scale (GDS', 'depression and anxiety', 'GDS scores', 'anxiety scores']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}]","[{'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",47.0,0.0298801,"There was no significant difference (p < 0.05) in anxiety scores between the two groups at 7 days, but there was a significant difference after 14 days of the intervention (p < 0.05).","[{'ForeName': 'Yen-Ting', 'Initials': 'YT', 'LastName': 'Tseng', 'Affiliation': 'Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'I-Hui', 'Initials': 'IH', 'LastName': 'Chen', 'Affiliation': 'Associate Professor, School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Pi-Hsia', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Professor, School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Pi-Chu', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': 'Professor, Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan. Electronic address: pclin02@gmail.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.08.003']
2393,32922966,Clinical Observation of Silicon Hydrogel Contact Lens Fitted Immediately after Small Incision Lenticule Extraction (SMILE).,"Purpose


To examine the immediate use of bandage contact lenses (BCLs) for improving patient comfort after small incision lenticule extraction (SMILE) surgery.
Methods


This is a prospective randomized controlled study in which one hundred and seventy-eight patients undergoing SMILE were randomly allocated to three groups: group A wore BCLs for 8 hours postsurgery, group B wore BCLs for 24 hours postsurgery, and group C did not wear any BCLs postsurgery. Eight subjective symptoms including photophobia, tearing, pain, foreign body sensation, burning, blurred vision, sting, and dry eyes were prospectively evaluated at 2 hours, 4 hours, 8 hours, and 24 hours, using a questionnaire with a total score of 24. The scores of symptoms and signs were compared between the three groups.
Results


There was a statistically significant time effect on scoring, which implicated a decline in symptoms over time after surgery ( P  < 0.001). There was also a significant interaction between time and the treatment group ( P  < 0.01). The total symptom score of groups A and B (5.85 ± 3.97 and 5.99 ± 4.67, respectively) was significantly lower than that of group C at 2 hours postsurgery (7.35 ± 4.86,  P  < 0.05), especially in tearing and pain ( P  < 0.05). The level of corneal oedema at 24 hours postsurgery was also statistically significantly different between the three groups ( P  < 0.001), and the post hoc test showed that groups A and B were lower than group C ( P  < 0.01).
Conclusion


Silicon hydrogel BCLs applied immediately after SMILE surgery can relieve postsurgical symptoms of tearing and pain, improving overall patient comfort, and reduce corneal oedema. This trial is registered with ChiCTR-ONRC-13003114.  Precis . The application of silicone hydrogel bandage contact lenses immediately after SMILE surgery has the potential to improve patient comfort, corneal healing, and patient satisfaction following SMILE.",2020,"The level of corneal oedema at 24 hours postsurgery was also statistically significantly different between the three groups ( P  < 0.001), and the post hoc test showed that groups A and B were lower than group C ( P  < 0.01).
","['one hundred and seventy-eight patients undergoing SMILE', 'patient comfort after small incision lenticule extraction (SMILE) surgery']","['Silicon Hydrogel Contact Lens Fitted Immediately after Small Incision Lenticule Extraction (SMILE', 'bandage contact lenses (BCLs', 'silicone hydrogel bandage contact lenses']","['tearing and pain', 'scores of symptoms and signs', 'photophobia, tearing, pain, foreign body sensation, burning, blurred vision, sting, and dry eyes', 'corneal oedema', 'total symptom score', 'level of corneal oedema']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1562032', 'cui_str': 'Bandage contact lens'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C1449669', 'cui_str': 'Hydrogel dressing'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0085636', 'cui_str': 'Photophobia'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",178.0,0.022058,"The level of corneal oedema at 24 hours postsurgery was also statistically significantly different between the three groups ( P  < 0.001), and the post hoc test showed that groups A and B were lower than group C ( P  < 0.01).
","[{'ForeName': 'Jifang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Eye & ENT Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Xi', 'Affiliation': 'Eye & ENT Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Eye & ENT Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Eye & ENT Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Eye & ENT Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xingtao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Eye & ENT Hospital, Fudan University, Shanghai, China.'}]",Journal of ophthalmology,['10.1155/2020/2604917']
2394,32923016,Efficacy and safety of triazavirin therapy for coronavirus disease 2019: A pilot randomized controlled trial.,"No therapeutics have been proven effective yet for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To assess the efficacy and safety of Triazavirin therapy for COVID-19, we conducted a randomized, double-blinded controlled trial involving hospitalized adult patients with COVID-19. Participants were enrolled from ten sites, and were randomized into two arms of the study with a ratio of 1:1. Patients were treated with Triazavirin 250 mg versus a placebo three or four times a day for 7 d. The primary outcome was set as the time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT) until 28 d after randomization. Secondary outcomes included individual components of the primary outcome, the mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling. Concomitant therapeutic treatments, adverse events, and serious adverse events were recorded. Our study was halted after the recruitment of 52 patients, since the number of new infections in the participating hospitals decreased greatly. We randomized 52 patients for treatment with Triazavirin ( n  = 26) or a placebo ( n  = 26). We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2). All components of the primary outcome normalized within 28 d, with the exception of absorption of pulmonary infection (Triazavirin 50.0%, placebo 26.1%). Patients in the Triazavirin group used less frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports. Although no statistically significant evidence was found to indicate that Triazavirin benefits COVID-19 patients, our observations indicated possible benefits from its use to treat COVID-19 due to its antiviral effects. Further study is required for confirmation.",2020,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","['Participants were enrolled from ten sites', 'hospitalized adult patients with COVID-19', 'coronavirus disease 2019']","['placebo', 'Triazavirin', 'Triazavirin therapy', 'triazavirin therapy']","['time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT', 'time to clinical improvement', 'mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling', 'frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports', 'efficacy and safety', 'absorption of pulmonary infection', 'adverse events, and serious adverse events', 'Efficacy and safety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2714695', 'cui_str': 'triazavirin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",52.0,0.423282,"We found no differences in the time to clinical improvement (median, 7 d vs. 12 d; risk ratio (RR), 2.0; 95% confidence interval (CI), 0.7-5.6;  p  = 0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5% vs. 23.1%, RR, 2.1; 95% CI, 0.6-7.0;  p  = 0.2).","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': ', ,.'}, {'ForeName': 'Yongchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Wanhai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ', ,.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ', ,.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ', ,.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Benzhi', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': ', ,.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ', ,.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ', ,.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ', ,.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ', ,.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ', ,.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': ', ,.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ', ,.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ', ,.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ', ,.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': ', ,.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': ', ,.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ', ,.'}]","Engineering (Beijing, China)",['10.1016/j.eng.2020.08.011']
2395,32923087,Improved outcome in early induction deaths in patients with acute promyelocytic leukemia after therapeutic and supportive interventions: a follow up study of seven-years' experience at a tertiary care center.,"INTRODUCTION AND OBJECTIVES


Acute promyelocytic leukemia (APL) is a unique subtype of acute myeloid leukemia with characteristic morphology and clinical features. Early mortality rate of 30% has been reported in developed countries despite prompt initiation of treatment. We have previously reported an early induction mortality of approximately 62% in our cohort. Based on this mortality rate, we made changes in our treatment protocol. The objective of this follow-up study was to report the early induction mortality and overall survival of patients with APL after incorporating changes in chemotherapy and supportive care regimen.
SUBJECTS AND METHODS


This was a prospective descriptive study conducted at Aga Khan University Karachi, Pakistan from October 2012 till October 2019. Data of patients included clinical features, morphological findings, cytogenetic and PCR studies, cytotoxic protocols, overall outcome and causes of early induction mortality. The changes in treatment protocol included prophylactic infusion of fresh frozen plasma, dexamethasone therapy and other changes in supportive care regimen. Results were recorded as frequencies and percentages. Statistical Package for the Social Sciences version 19.0 (SPSS Inc., Chicago, IL, USA) was used to analyze patient's data. Survival curves were calculated using the Kaplan-Meier method.
RESULTS


During the study period, total of 447 patients presented with acute myeloid leukemia at our institution out of which 40 patients were diagnosed with acute promyelocytic leukemia (9%). Out of these 40 patients 24 were males and 16 were females. The median age was 37 years. Twenty-five patients were in low risk group whereas 15 were high-risk. Differentiation syndrome was seen in 14 patients. As a part of induction chemotherapy, 13 patients received only ATRA because they were not eligible for chemotherapy and 17 patients received a combination of ATRA and anthracycline. Among the remaining patients, four received ATRA, arsenic and anthracycline while two received ATRA and arsenic only. Four patients did not receive any treatment because of rapid deterioration of clinical condition and death. The overall survival was 65% and early induction mortality was 30%.
CONCLUSION


The early induction mortality decreased to 30% from 62% in this study and the overall survival was 65%. With the introduction of prophylactic infusion of fresh frozen plasma, dexamethasone and appropriate supportive treatment during the induction chemotherapy, we were able to improve the induction mortality and overall survival of patients.",2020,"The overall survival was 65% and early induction mortality was 30%.
","['40 patients 24 were males and 16 were females', 'patients with acute promyelocytic leukemia after therapeutic and supportive interventions', '13 patients received only ATRA because they were not eligible for chemotherapy and 17 patients received a', 'at Aga Khan University Karachi, Pakistan from October 2012 till October 2019', '447 patients presented with acute myeloid leukemia at our institution out of which 40 patients were diagnosed with acute promyelocytic leukemia (9', 'Twenty-five patients were in low risk group whereas 15 were high-risk', ""seven-years' experience at a tertiary care center"", '14 patients', 'patients with APL after incorporating changes in chemotherapy and supportive care regimen', 'Acute promyelocytic leukemia (APL']","['ATRA, arsenic and anthracycline', 'fresh frozen plasma, dexamethasone', 'combination of ATRA and anthracycline', 'fresh frozen plasma, dexamethasone therapy']","['induction mortality', 'Survival curves', 'rapid deterioration of clinical condition and death', 'mortality rate', 'early induction mortality and overall survival', 'Differentiation syndrome', 'induction mortality and overall survival', 'Early mortality rate', 'early induction deaths', 'early induction mortality', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0860564', 'cui_str': 'Differentiation syndrome'}]",40.0,0.0432204,"The overall survival was 65% and early induction mortality was 30%.
","[{'ForeName': 'Mohammad Usman', 'Initials': 'MU', 'LastName': 'Shaikh', 'Affiliation': 'Department of Pathology and Laboratory Medicine/Oncology, Aga Khan University Karachi, Pakistan.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Pathology and Laboratory Medicine/Oncology, Aga Khan University Karachi, Pakistan.'}, {'ForeName': 'Farheen', 'Initials': 'F', 'LastName': 'Karim', 'Affiliation': 'New Cross Hospital, Royal Wolverhampton NHS Trust UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Raheem', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Aga Khan University Karachi, Pakistan.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Sarwar', 'Affiliation': 'Chughtai Laboratory Lahore Pakistan.'}]",American journal of blood research,[]
2396,32923094,Outcomes at 5 years in patients with severe aortic stenosis: reviewing current information using the restricted mean survival time.,"The information about outcomes at 5 years in patients receiving transcatheter aortic valve replacement (TAVR) has grown. We interpreted the information on this topic using the restricted mean survival time (RMST). The purpose of our study was to summarise the current evidence using an original outcome measure with potential methodological advantages. Four cohorts of patients, previously published in the literature, met our criterion of 5 years of follow-up after the implant; another cohort was identified from a group of controls subjected to surgical replacement of the valve. The estimated values of RMST at 5 years for the 5 patient cohorts were the following (N = number of patients, all time values in years): a) real-world high surgical risk cohort: N = 114, RMST = 3.80; b) real-world cohort treated with Corevalve: N = 309, RMST = 3.79; c) a real-world cohort treated with Sapien: N = 180, RMST = 3.61; d) TAVR arm of a randomized trial in intermediate risk patients: N = 1,011; RMST = 3.73; e) surgical replacement arm of the same trial: N = 1,021, RMST = 3.72. The main result of our analysis based on the RMST is represented by the extreme homogeneity of the outcomes (RMSTs ranging from 3.61 to 3.80 years per patient) that remained virtually constant irrespective of the baseline risk of the patients (intermediate or high risk) and regardless of whether the intervention was transcatheter or by surgical replacement. Last but not least, our analysis showed the good methodological performance of the RMST in this disease condition.",2020,The estimated values of RMST at 5 years for the 5 patient cohorts were the following,"['patients with severe aortic stenosis', 'intermediate risk patients: N = 1,011; RMST = 3.73; e) surgical replacement arm of the same trial: N = 1,021, RMST ']","['transcatheter aortic valve replacement (TAVR', 'real-world cohort treated with Sapien']","['mean survival time (RMST', 'mean survival time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}]",,0.0358133,The estimated values of RMST at 5 years for the 5 patient cohorts were the following,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Messori', 'Affiliation': 'HTA Unit, Toscana Region Health Service Toscana Region, Florence, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bartoli', 'Affiliation': 'HTA Unit, Toscana Region Health Service Toscana Region, Florence, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Trippoli', 'Affiliation': 'HTA Unit, Toscana Region Health Service Toscana Region, Florence, Italy.'}]",American journal of cardiovascular disease,[]
2397,32923547,Eye hemodynamic data and biochemical parameters of the lacrimal fluid of patients with non-proliferative diabetic retinopathy.,"This paper presents a data from examinations of patients treated in clinic of Tashkent medical academy, Uzbekistan. 165 Patients (305 eyes) with NPDR were randomly allocated to receive standard treatment as the control group, in addition to the standard treatment daily tablets of EGb 761 (Tanakan, Beaufour Ipsen Industrie, Paris, France) 120 mg as the 1st main group, or daily endonasal electrophoresis of Tanakan 40 mg as 2nd main group, within 10 days. All of the patients underwent baseline ophthalmologic examinations, definition of biochemical parameters of the lacrimal fluid and Doppler ultrasound imaging of the eye. Moreover, correlation between tear fluid and hemodynamics was calculated. This data is essential for researchers to develop diagnostic criteria for diabetic retinopathy stages. Data are also beneficial to practitioners in determining the diabetic retinopathy severity and choosing appropriate treatment.",2020,"165 Patients (305 eyes) with NPDR were randomly allocated to receive standard treatment as the control group, in addition to the standard treatment daily tablets of EGb 761 (Tanakan, Beaufour Ipsen Industrie, Paris, France) 120 mg as the 1st main group, or daily endonasal electrophoresis of Tanakan 40 mg as 2nd main group, within 10 days.","['165 Patients (305 eyes) with NPDR', 'patients with non-proliferative diabetic retinopathy', 'patients treated in clinic of Tashkent medical academy, Uzbekistan']","['standard treatment daily tablets of EGb 761 (Tanakan, Beaufour Ipsen Industrie, Paris, France) 120 mg as the 1st main group, or daily endonasal electrophoresis of Tanakan 40 mg as 2nd main group']",[],"[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0004606', 'cui_str': 'Nonproliferative diabetic retinopathy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0042177', 'cui_str': 'Uzbekistan'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1095795', 'cui_str': 'EGb 761'}, {'cui': 'C0525094', 'cui_str': 'Tanakan'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0225425', 'cui_str': 'Internal nose structure'}, {'cui': 'C0013855', 'cui_str': 'Electrophoresis'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",[],,0.02847,"165 Patients (305 eyes) with NPDR were randomly allocated to receive standard treatment as the control group, in addition to the standard treatment daily tablets of EGb 761 (Tanakan, Beaufour Ipsen Industrie, Paris, France) 120 mg as the 1st main group, or daily endonasal electrophoresis of Tanakan 40 mg as 2nd main group, within 10 days.","[{'ForeName': 'Guzal', 'Initials': 'G', 'LastName': 'Kangilbaeva', 'Affiliation': 'Department of Ophthalmology, Tashkent Medical Academy, Tashkent, Uzbekistan.'}, {'ForeName': 'Fazilat', 'Initials': 'F', 'LastName': 'Bakhritdinova', 'Affiliation': 'Department of Ophthalmology, Tashkent Medical Academy, Tashkent, Uzbekistan.'}, {'ForeName': 'Iroda', 'Initials': 'I', 'LastName': 'Nabieva', 'Affiliation': 'Clinic of Research Institute of Endocrinology, Tashkent, Uzbekistan.'}, {'ForeName': 'Aziza', 'Initials': 'A', 'LastName': 'Jurabekova', 'Affiliation': 'Nazar Medical Eye Clinic, Tashkent, Uzbekistan.'}]",Data in brief,['10.1016/j.dib.2020.106237']
2398,32923686,Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial.,"Background : Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control).  Methods : We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted.  Results : A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22).  Conclusions : In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met.  Trial registration : ClinicalTrials.gov NCT02373592 (27/02/2015).",2020,DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm.,"['enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment and allocating them to', 'diabetic foot ulcers', '172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group']","['control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care', 'mHeath-based supplementation', ' ']","['history of DFU', 'Hazard Ratio (HR) for DFU', 'DFU cumulative incidence', 'diabetic foot ulcers (DFUs) incidence', 'time to occurrence of DFU']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0302603', 'cui_str': 'Liquid Crystals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",172.0,0.219747,DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lazo-Porras', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bernabe-Ortiz', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Taype-Rondan', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Gilman', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Helard', 'Initials': 'H', 'LastName': 'Manrique', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Neyra', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Calderon', 'Affiliation': 'Endocrinology Service, Hospital Nacional Arzobispo Loayza, Lima, Peru.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pinto', 'Affiliation': 'Endocrinology Service, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Armstrong', 'Affiliation': 'Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'J Jaime', 'Initials': 'JJ', 'LastName': 'Miranda', 'Affiliation': 'CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",Wellcome open research,['10.12688/wellcomeopenres.15531.2']
2399,32923836,Real-World Effectiveness of Obeticholic Acid in Patients with Primary Biliary Cholangitis.,"Patients with primary biliary cholangitis (PBC) with incomplete response to ursodeoxycholic acid are at risk of disease progression and need additional therapy. Obeticholic acid (OCA) was approved in Canada in May 2017, but its effectiveness in a real-world setting has not been described. We sought to describe our experience with OCA in a Canadian cohort. OCA-naive patients treated at two Canadian centers were included. Clinical and biochemical data were collected at OCA initiation and during follow-up. Primary outcomes were changes in serum alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and total bilirubin (TB) over the duration of therapy. Secondary outcomes were changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), immunoglobulin M (IgM), platelets, and albumin; and achievement of the primary endpoint of the original phase 3 study that led to OCA approval (A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis [POISE]), dose reductions, discontinuations, and tolerability. Repeated-measures models were used to assess changes in biochemistry over time. Sixty-four patients were included; 4 carried a diagnosis of overlap with autoimmune hepatitis. Mean age was 54.6 years, median ALP was 250 U/L, TB was 13 µmol/L, platelet count was 225 × 10 9 /L, and 24% had liver stiffness measurements ≥16.9 kPa. There was a significant reduction in mean ALP of 55 U/L ( P  < 0.001), GGT of 138 U/L ( P  < 0.001), ALT of 11.9 U/L ( P  < 0.001), AST of 5.7 U/L ( P  < 0.05), and IgM of 0.70 g/L ( P  < 0.001) over 12 months; TB remained stable ( P  = 0.98). Forty-four patients met POISE-inclusion criteria, 39% (n = 17) of whom had 12-month biochemical measurements. In this subset, 18% (n = 3/17) met the 12-month POISE primary endpoint, but considering follow-up to 19 months, 43% achieved this target (n = 9/21). Pruritus was the most commonly reported complaint.  Conclusion : Use of OCA was associated with improvement in biochemical surrogates of outcome in PBC in a real-world setting.",2020,"There was a significant reduction in mean ALP of 55 U/L ( P  < 0.001), GGT of 138 U/L ( P  < 0.001), ALT of 11.9 U/L ( P  ","['OCA-naive patients treated at two Canadian centers were included', 'Mean age was 54.6\xa0years, median ALP was 250\xa0U/L, TB was 13\xa0µmol/L, platelet count was 225\xa0×', 'Patients with Primary Biliary Cholangitis', 'Patients with primary biliary cholangitis (PBC', 'Forty-four patients met POISE-inclusion criteria, 39% (n\xa0=\xa017) of whom had 12-month biochemical measurements', 'Sixty-four patients were included; 4 carried a diagnosis of overlap with autoimmune hepatitis']","['OCA', 'Obeticholic acid (OCA', 'ursodeoxycholic acid', 'Obeticholic Acid']","['Obeticholic Acid in Primary Biliary Cholangitis [POISE]), dose reductions, discontinuations, and tolerability', 'changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), immunoglobulin M (IgM), platelets, and albumin; and achievement of the primary endpoint', 'Pruritus', 'serum alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and total bilirubin (TB) over the duration of therapy', 'mean ALP of 55\xa0U/L']","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0444864', 'cui_str': 'AM 13'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0439115', 'cui_str': 'P'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}]",64.0,0.301182,"There was a significant reduction in mean ALP of 55 U/L ( P  < 0.001), GGT of 138 U/L ( P  < 0.001), ALT of 11.9 U/L ( P  ","[{'ForeName': 'Surain B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': 'Toronto Centre for Liver Disease Toronto General Hospital University Health Network Toronto ON Canada.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Ismail', 'Affiliation': 'Toronto Centre for Liver Disease Toronto General Hospital University Health Network Toronto ON Canada.'}, {'ForeName': 'Gowthami', 'Initials': 'G', 'LastName': 'Kanagalingam', 'Affiliation': 'Toronto Centre for Liver Disease Toronto General Hospital University Health Network Toronto ON Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Mason', 'Affiliation': 'Department of Medicine University of Alberta Edmonton AB Canada.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Swain', 'Affiliation': 'Department of Medicine University of Calgary Calgary AB Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Vincent', 'Affiliation': 'Département de Médecine Université de Montréal Montréal QC Canada.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medicine University of British Columbia Vancouver BC Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Tsien', 'Affiliation': 'Department of Medicine University of Ottawa Ottawa ON Canada.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Flemming', 'Affiliation': ""Department of Medicine Queen's University Kingston ON Canada.""}, {'ForeName': 'Harry L A', 'Initials': 'HLA', 'LastName': 'Janssen', 'Affiliation': 'Toronto Centre for Liver Disease Toronto General Hospital University Health Network Toronto ON Canada.'}, {'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease Toronto General Hospital University Health Network Toronto ON Canada.'}, {'ForeName': 'Bettina E', 'Initials': 'BE', 'LastName': 'Hansen', 'Affiliation': 'Toronto Centre for Liver Disease Toronto General Hospital University Health Network Toronto ON Canada.'}, {'ForeName': 'Aliya F', 'Initials': 'AF', 'LastName': 'Gulamhusein', 'Affiliation': 'Toronto Centre for Liver Disease Toronto General Hospital University Health Network Toronto ON Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hepatology communications,['10.1002/hep4.1518']
2400,32923850,Plasma Androgen Receptor Copy Number Status at Emergence of Metastatic Castration-Resistant Prostate Cancer: A Pooled Multicohort Analysis.,"PURPOSE


Increases in androgen receptor ( AR ) copy number (CN) can be detected in plasma DNA when patients develop metastatic castration-resistant prostate cancer. We aim to evaluate the association between  AR  CN as a continuous variable and clinical outcome.
PATIENTS AND METHODS


PCR2023 was an international, multi-institution, open-label, phase II study of abiraterone acetate plus prednisolone (AAP) or abiraterone acetate plus dexamethasone that included plasma  AR  assessment as a predefined exploratory secondary end point. Plasma  AR  CN data (ClinicalTrials.gov identifier: NCT01867710) from this study (n = 133) were pooled with data from the following three other cohorts: cohort A, which was treated with either AAP or enzalutamide (n = 73); the PREMIERE trial (ClinicalTrials.gov identifier: NCT02288936) of biomarkers for enzalutamide (n = 94); and a phase II trial from British Columbia (ClinicalTrials.gov identifier: NCT02125357) that randomly assigned men to either AAP or enzalutamide (n = 201). The primary outcome measures for the biomarker analysis were overall survival and progression-free survival.
RESULTS


Using multivariable fractional polynomials analysis using Cox regression models, a nonlinear relationship between plasma  AR  CN and outcome was identified for overall survival, where initially for small incremental gains in CN there was a large added hazard ratio that plateaued at higher CN. The CN cut point associated with the highest local hazard ratio was 1.92. A similar nonlinear association was observed with progression-free survival. In an exploratory analysis of PCR2023, the time from start of long-term androgen-deprivation therapy to start of AAP or abiraterone acetate plus dexamethasone was significantly shorter in patients with plasma  AR  CN of 1.92 or greater than patients with plasma  AR  CN of less than 1.92 (43  v  130 weeks, respectively;  P  = .005). This was confirmed in cohort A ( P  = .003), the PREMIERE cohort ( P  = .03), and the British Colombia cohort ( P  = .003).
CONCLUSION


Patients with metastatic castration-resistant prostate cancer can be dichotomized by a plasma  AR  CN cut point of 1.92. Plasma  AR  CN value of 1.92 or greater identifies aggressive disease that is poorly responsive to AR targeting and is associated with a prior short response to primary androgen-deprivation therapy.",2019,"This was confirmed in cohort A ( P  = .003), the PREMIERE cohort ( P  = .03), and the British Colombia cohort ( P  = .003).
","['patients develop metastatic castration-resistant prostate cancer', 'n = 133) were pooled with data from the following three other cohorts: cohort A, which was treated with either', 'Metastatic Castration-Resistant Prostate Cancer', 'Patients with metastatic castration-resistant prostate cancer']","['AAP or enzalutamide', 'enzalutamide', 'abiraterone acetate plus prednisolone (AAP) or abiraterone acetate plus dexamethasone', 'AAP or abiraterone acetate plus dexamethasone']","['progression-free survival', 'overall survival and progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",133.0,0.16697,"This was confirmed in cohort A ( P  = .003), the PREMIERE cohort ( P  = .03), and the British Colombia cohort ( P  = .003).
","[{'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Jayaram', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wingate', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wetterskog', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Conteduca', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Khalaf', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mansour Taghavi Azar', 'Initials': 'MTA', 'LastName': 'Sharabiani', 'Affiliation': 'The School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Calabrò', 'Affiliation': 'San Camillo and Forlanini Hospitals, Rome, Italy.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Barwell', 'Affiliation': 'University of Glasgow, The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martinez-Carrasco', 'Affiliation': 'Hospital Universitario Morales Meseguer, Biobanco Nodo 3, Instituto Murciano de Investigación Biosanitaria-Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Font', 'Affiliation': ""Institut Catala d'Oncologia-Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berruti', 'Affiliation': 'University of Brescia, Spedali Civili Hospital, Brescia, Italy.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Lefresne', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Lahaye', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Shibu', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Shilpy', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'HireGenics, Duluth, GA.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ricci', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gormley', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Axel S', 'Initials': 'AS', 'LastName': 'Merseburger', 'Affiliation': 'University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Institut de Recherche Clinique, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gonzalez-Billalabeitia', 'Affiliation': 'Hospital Universitario Morales Meseguer, Biobanco Nodo 3, Instituto Murciano de Investigación Biosanitaria-Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}]",JCO precision oncology,['10.1200/PO.19.00123']
2401,32929906,[Effectiveness of percutaneous injection of autologous concentrated bone marrow aspirate combined with platelet-rich plasma in treatment of delayed fracture healing].,"Objective


To analyze the effectiveness of percutaneous injection of autologous concentrated bone marrow aspirate (cBMA) combined with platelet-rich plasma (PRP) in the treatment of delayed fracture healing.
Methods


A prospective, randomized, controlled, single-blind case study was conducted. Between March 2016 and July 2018, 66 patients who met the inclusion and exclusion criteria for delayed fracture healing but had solid internal fixation of the fracture end were randomly divided into control group (31 cases, treated with percutaneous autogenous bone marrow blood injection) and study group (35 cases, treated with percutaneous autogenous cBMA+PRP injection). General data such as gender, age, body mass index, site of delayed fracture healing, length of bone defect at fracture end, and preoperative radiographic union score for tibia (RUST) showed no significant difference between the two groups (  P >0.05). Before injection, Kirschner wire was used in both groups to stimulate the fracture end and cause minor injury. The fracture healing time, treatment cost, and adverse reactions were recorded and compared between the two groups. Visual analogue scale (VAS) score was used to evaluate pain improvement. The tibial RUST score was extended to the tubular bone healing evaluation.
Results


No infection of bone marrow puncture needle eyes occurred in both groups. In the control group, local swelling was obvious in 5 cases and pain was aggravated at 1 day after operation in 11 cases. In the study group, postoperative swelling and pain were not obvious, but 2 cases presented local swelling and pain. All of them relieved after symptomatic treatment. Patients in both groups were followed up, the follow-up time of the control group was 16-36 months (mean, 21.8 months), and the study group lasted 14-33 months (mean, 23.2 months). The amount of bone marrow blood was significantly lower in the study group than in the control group (  t =4.610,  P =0.000). The degree of postoperative pain in the study group was less than that in the control group, and the treatment cost was higher than that in the control group. But the differences between the two groups in VAS score at 1 day after operation and treatment cost were not significant (  P >0.05). Fracture healing was achieved in 19 cases (61.3%) in the control group and 30 cases (85.7%) in the study group. The difference in fracture healing rate between the two groups was significant (  χ   2 =5.128,  P =0.024). Fracture healing time and RUST score at last follow-up were significantly better in the study group than in the control group (  P <0.05). At last follow-up, RUST scores in both groups were significantly improved when compared with those before operation (  P <0.05).
Conclusion


Autogenous cBMA combined with PRP percutaneous injection can provide high concentration of BMSCs and growth factors, and can improve the fracture healing rate and shorten the fracture healing time better than autogenous bone marrow blood injection.",2020,Fracture healing time and RUST score at last follow-up were significantly better in the study group than in the control group (  P <0.05).,"['delayed fracture healing', 'Between March 2016 and July 2018, 66 patients who met the inclusion and exclusion criteria for delayed fracture healing but had solid internal fixation of the fracture end']","['percutaneous autogenous bone marrow blood injection', 'percutaneous autogenous cBMA+PRP injection', 'Kirschner wire', 'percutaneous injection of autologous concentrated bone marrow aspirate combined with platelet-rich plasma', 'PRP percutaneous injection', 'percutaneous injection of autologous concentrated bone marrow aspirate (cBMA) combined with platelet-rich plasma (PRP']","['postoperative swelling and pain', 'fracture healing rate', 'RUST scores', 'Visual analogue scale (VAS) score', 'preoperative radiographic union score for tibia (RUST', 'infection of bone marrow puncture needle eyes', 'pain', 'fracture healing time, treatment cost, and adverse reactions', 'local swelling and pain', 'amount of bone marrow blood', 'VAS score', 'tibial RUST score', 'treatment cost', 'local swelling', 'Fracture healing', 'Fracture healing time and RUST score', 'degree of postoperative pain', 'pain improvement']","[{'cui': 'C0332743', 'cui_str': 'Delayed union of fracture'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0857285', 'cui_str': 'Bone marrow aspirate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C2242472', 'cui_str': 'Infection of bone'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0853619', 'cui_str': 'Localized swelling'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0149596,Fracture healing time and RUST score at last follow-up were significantly better in the study group than in the control group (  P <0.05).,"[{'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}, {'ForeName': 'Wuyin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yue', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}, {'ForeName': 'Youwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hip Injury Center, Luoyang-Orthopedic Traumatological Hospital of Henan Province (Henan Orthopedic Hospital), Luoyang Henan, 471002, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.202002028']
2402,32929910,[Efficacy and safety of tranexamic acid sequential rivaroxaban on blood loss in elderly patients during lumbar interbody fusion].,"Objective


To investigate the effect and safety of tranexamic acid sequential rivaroxaban on perioperative blood loss and preventing thrombosis for elderly patients during lumbar interbody fusion (LIF) with a prospective randomized controlled study.
Methods


Between April and October 2019, the elderly patients with lumbar degenerative diseases requiring LIF were included in the study, among which were 80 patients met the selection criteria. According to the antifibrinolysis and anticoagulation protocols, they were randomly divided into a tranexamic acid sequential rivaroxaban group (trial group) and a simple rivaroxaban group (control group) on average. Finally, 69 patients (35 in the trial group and 34 in the control group) were included for comparison. There was no significant difference in general data (  P >0.05) such as gender, age, body mass index, disease duration, diseased segment, type of disease, and preoperative hemoglobin between the two groups. The operation time, intraoperative blood loss, drainage within 3 days after operation, perioperative total blood loss, and proportion of blood transfusion patients were compared between the two groups, as well as postoperative venous thrombosis of lower extremities, pulmonary embolism, and bleeding-related complications.
Results


The operations of the two groups completed successfully, and there was no significant difference in the operation time (  P >0.05); the intraoperative blood loss, drainage within 3 days after operation, and perioperative total blood loss in the trial group were significantly lower than those in the control group (  P <0.05). The proportion of blood transfusion patients in the trial group was 25.71% (9/35), which was significantly lower than that in the control group [52.94% (18/34)] (  χ   2 =5.368,  P =0.021). Postoperative incision bleeding occurred in 4 cases of the trial group and 3 cases of the control group, and there was no significant difference in bleeding-related complications between the two groups (  P =1.000). There was 1 case of venous thrombosis of the lower extremities in each group after operation, and there was no significant difference in the incidence between the two groups (  P =1.000). Besides, no pulmonary embolism occurred in the two groups.
Conclusion


Perioperative use of tranexamic acid sequential rivaroxaban in elderly LIF patients can effectively reduce the amount of blood loss and the proportion of blood transfusion patients without increasing the risk of postoperative thrombosis.",2020,"There was no significant difference in general data (  P >0.05) such as gender, age, body mass index, disease duration, diseased segment, type of disease, and preoperative hemoglobin between the two groups.","['elderly patients during lumbar interbody fusion (LIF', 'elderly patients during lumbar interbody fusion', '69 patients (35 in the trial group and 34 in the control group) were included for comparison', 'elderly patients with lumbar degenerative diseases requiring LIF were included in the study, among which were 80 patients met the selection criteria', 'elderly LIF patients']","['tranexamic acid sequential rivaroxaban', 'rivaroxaban']","['venous thrombosis of the lower extremities', 'Postoperative incision bleeding', 'pulmonary embolism', 'perioperative blood loss', 'operation time, intraoperative blood loss, drainage within 3 days after operation, perioperative total blood loss, and proportion of blood transfusion patients', 'proportion of blood transfusion', 'bleeding-related complications', 'general data', 'postoperative venous thrombosis of lower extremities, pulmonary embolism, and bleeding-related complications', 'operation time', 'intraoperative blood loss, drainage within 3 days after operation, and perioperative total blood loss', 'blood loss', 'body mass index, disease duration, diseased segment, type of disease, and preoperative hemoglobin']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1285162', 'cui_str': 'Degenerative disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0235753,"There was no significant difference in general data (  P >0.05) such as gender, age, body mass index, disease duration, diseased segment, type of disease, and preoperative hemoglobin between the two groups.","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an Shaanxi, 710054, P.R.China.""}, {'ForeName': 'Dingjun', 'Initials': 'D', 'LastName': 'Hao', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an Shaanxi, 710054, P.R.China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an Shaanxi, 710054, P.R.China.""}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an Shaanxi, 710054, P.R.China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Hui', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an Shaanxi, 710054, P.R.China.""}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.202002041']
2403,32929921,[The use of Akatinol Memantine in the treatment of gait disturbances in Parkinson's disease].,"OBJECTIVE


To assess the efficacy of memantine hydrochloride in the treatment of GD in PD patients.
MATERIALS AND METHODS


Patients of the main group ( n =30) received memantine hydrochloride (akatinol memantine) in a dose of 20 mg/day for 3 months in addition to antiparkinsonian therapy. Patients of the comparison group ( n =25) received only antiparkinsonian drugs. Cognitive rating scales and computerized gait assessment protocol were performed in both groups twice in 3 months interval in order to examine cognitive deficit and gait parameters.
RESULTS


The increase in MMSE scores, improvement in gait cycle phases ratio and increase of cadence according to computerized gait analysis were observed in the main group compared to the comparison group.
CONCLUSION


The improvement in gait achieved during the study confirms that the treatment of cortical gait disturbances in patients with PD using memantine hydrochloride is a promising area of therapy.",2020,"The increase in MMSE scores, improvement in gait cycle phases ratio and increase of cadence according to computerized gait analysis were observed in the main group compared to the comparison group.
","[""gait disturbances in Parkinson's disease"", 'PD patients', 'patients with PD', 'Patients of the main group ( n =30) received']","['Akatinol Memantine', 'antiparkinsonian drugs', 'memantine hydrochloride (akatinol memantine', 'memantine hydrochloride']","['cortical gait disturbances', 'Cognitive rating scales and computerized gait assessment protocol', 'MMSE scores, improvement in gait cycle phases ratio and increase of cadence according to computerized gait analysis']","[{'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0003405', 'cui_str': 'Antiparkinson agent'}, {'cui': 'C0771988', 'cui_str': 'Memantine hydrochloride'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]",,0.0259252,"The increase in MMSE scores, improvement in gait cycle phases ratio and increase of cadence according to computerized gait analysis were observed in the main group compared to the comparison group.
","[{'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Miliukhina', 'Affiliation': 'Institute of Experimental Medicine, St. Petersburg, Russia.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Gracheva', 'Affiliation': 'Institute of Experimental Medicine, St. Petersburg, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012007127']
2404,32930011,Culturally adapted family intervention for schizophrenia in Pakistan: a feasibility study.,"OBJECTIVES


To establish feasibility and acceptability of a Culturally adapted Family Intervention (CulFI) that was developed using an empirically derived conceptual framework in Pakistan.
METHODS


A rater-blind, randomised trial to evaluate the feasibility and acceptability of delivering CulFI compared to treatment as usual in Karachi, Pakistan. Indicators of feasibility included evaluation of recruitment rates, retention and randomisation. We also evaluated the acceptability of the intervention and trial procedures.
RESULTS


Excellent recruitment and retention rates informed the feasibility of the intervention. CulFI had more than a 90% participant attendance of 8-10 sessions and retained more than 90% who commenced in the intervention. Eighty percent of those who initially provided consent were willing to be randomised and the quality of CulFI was rated as good to excellent by 85.7% of participants.
CONCLUSIONS


Importantly, this study determines that pathways into a psychosocial intervention can be established in Pakistan. A combination of factors contribute to low levels of access to psychiatric care including different explanatory models of illness, small numbers of trained staff, limited resources and reliance on traditional healers. These results support the feasibility, acceptability and merit of conducting a full-scale trial of CulFI in comparison with standard care.  ClinicalTrials.gov Identifier:  NCT02167347 KEY POINTS The significant treatment gap in LMICs leaves families providing much of the care for people with schizophrenia. There is limited evidence from LMICs supporting the effectiveness and feasibility of psychosocial interventions more broadly, and family interventions specifically. This study adds to the scarce literature and demonstrates that pathways into delivering psychosocial interventions can be established in Pakistan. The results of this trial support the feasibility and acceptability of a Culturally adapted Family Intervention (CulFI) for schizophrenia patients and their families in Pakistan A full-scale trial of CulFI in comparison with standard care is warranted to determine clinical and cost-effectiveness.",2020,The results of this trial support the feasibility and acceptability of a Culturally adapted Family Intervention (CulFI) for schizophrenia patients and their families in Pakistan A full-scale trial of CulFI in comparison with standard care is warranted to determine clinical and cost-effectiveness.,"['schizophrenia in Pakistan', 'schizophrenia patients and their families in Pakistan A full-scale trial of CulFI in comparison with standard care']","['Culturally adapted Family Intervention (CulFI', 'CulFI']",['quality of CulFI'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0821045,The results of this trial support the feasibility and acceptability of a Culturally adapted Family Intervention (CulFI) for schizophrenia patients and their families in Pakistan A full-scale trial of CulFI in comparison with standard care is warranted to determine clinical and cost-effectiveness.,"[{'ForeName': 'Muhammad Omair', 'Initials': 'MO', 'LastName': 'Husain', 'Affiliation': 'School of Biological Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Ameer B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Living and Learning, Karachi, Pakistan.'}, {'ForeName': 'Laoise', 'Initials': 'L', 'LastName': 'Renwick', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning, Karachi, Pakistan.'}, {'ForeName': 'Sofiya', 'Initials': 'S', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning, Karachi, Pakistan.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'Imran B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'School of Biological Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}]",International journal of psychiatry in clinical practice,['10.1080/13651501.2020.1819332']
2405,32930333,A pilot study to determine the consistency of peak forces during cervical spine manipulation utilizing mannequins.,"OBJECTIVE


Cervical spine manipulation is a complex motor skill used to treat musculoskeletal ailments such as neck pain. There is evidence demonstrating the effectiveness of objective feedback and mannequins for the teaching of spinal manipulation (SM) in the thoracic and lumbar spine. This paper examines the effectiveness of an educational intervention combining both mannequins and force-sensing technology for teaching cervical SM.
METHODS


Fourth-year chiropractic interns were separated into 2 groups: an intervention group and a group trained with the standard curriculum. The intervention included a 60-minute educational session focused on targeting 100 N total peak force cervical manipulations on mannequins, with objective feedback through force-sensing table technology. Pre- and post-CMs were recorded on both a mannequin and a paired student partner, with an attempt to have a target total peak force of 100 N.
RESULTS


Ninety students were recruited. The invention group (n = 46) scored significantly better at the outcome compared to the control group (n = 44) when manipulating the mannequin (p = .003). These improvements did not carry over when manipulating a paired human partner (p = .067).
CONCLUSION


Following a 1-hour cervical SM educational intervention utilizing thrusting on mannequins and force-sensing table technology, students demonstrated improved peak force control for SM delivered on the mannequin. However, this improvement was not carried over to SM delivered on human subjects.",2020,The invention group (n = 46) scored significantly better at the outcome compared to the control group (n = 44) when manipulating the mannequin (p = .003).,"['Fourth-year chiropractic interns', 'Ninety students were recruited']","['educational intervention combining both mannequins and force-sensing technology', 'intervention group and a group trained with the standard curriculum', '60-minute educational session focused on targeting 100 N total peak force cervical manipulations on mannequins, with objective feedback through force-sensing table technology']",[],"[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0600576', 'cui_str': 'Neck manipulation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039224', 'cui_str': 'Table'}]",[],90.0,0.0308367,The invention group (n = 46) scored significantly better at the outcome compared to the control group (n = 44) when manipulating the mannequin (p = .003).,"[{'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Duquette', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Starmer', 'Affiliation': ''}, {'ForeName': 'Josh B', 'Initials': 'JB', 'LastName': 'Plener', 'Affiliation': ''}, {'ForeName': 'Dominic A Giuliano', 'Initials': 'DAG', 'LastName': 'BSc', 'Affiliation': ''}]",The Journal of chiropractic education,['10.7899/JCE-18-33']
2406,32930336,Aging Modulates Prefrontal Plasticity Induced by Executive Control Training.,"While declines in inhibitory control, the capacity to suppress unwanted neurocognitive processes, represent a hallmark of healthy aging, whether this function is susceptible to training-induced plasticity in older populations remains largely unresolved. We addressed this question with a randomized controlled trial investigating the changes in behavior and electrical neuroimaging activity induced by a 3-week adaptive gamified Go/NoGo inhibitory control training (ICT). Performance improvements were accompanied by the development of more impulsive response strategies, but did not generalize to impulsivity traits nor quality of life. As compared with a 2-back working-memory training, the ICT in the older adults resulted in a purely quantitative reduction in the strength of the activity in a medial and ventrolateral prefrontal network over the 400 ms P3 inhibition-related event-related potentials component. However, as compared with young adults, the ICT induced distinct configurational modifications in older adults' 200 ms N2 conflict monitoring medial-frontal functional network. Hence, while older populations show preserved capacities for training-induced plasticity in executive control, aging interacts with the underlying plastic brain mechanisms. Training improves the efficiency of the inhibition process in older adults, but its effects differ from those in young adults at the level of the coping with inhibition demands.",2020,"Performance improvements were accompanied by the development of more impulsive response strategies, but did not generalize to impulsivity traits nor quality of life.",['older adults'],"['2-back working-memory training', 'ICT', 'NoGo inhibitory control training (ICT', 'Executive Control Training']","['impulsivity traits nor quality of life', 'efficiency of the inhibition process']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",,0.027188,"Performance improvements were accompanied by the development of more impulsive response strategies, but did not generalize to impulsivity traits nor quality of life.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Najberg', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wachtl', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Anziano', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mouthon', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Spierer', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhaa259']
2407,32930386,Overdiagnosis in lung cancer screening - estimates from the German Lung Cancer Screening Intervention Trial.,"Overdiagnosis is a major potential harm of lung cancer screening; knowing its potential magnitude helps to optimize screening eligibility criteria. The German Lung Screening Intervention Trial (""LUSI"") is a randomized trial among 4052 long-term smokers (2622 men), 50.3-71.9 years of age from the general population around Heidelberg, Germany, comparing five annual rounds of low-dose computed tomography (n=2029) with a control arm without intervention (n=2023). After a median follow-up of 9.77 years post-randomization and 5.73 years since last screening, 74 participants were diagnosed with lung cancer in the control arm and 90 in the screening arm: 69 during the active screening period; of which 63 screen-detected and 6 interval cancers. The excess cumulative incidence in the screening arm (N=16) represented 25.4% [95%CI -11.3, 64.3] of screen-detected cancer cases (N=63). Analyzed by histologic subtype, excess incidence in the screening arm appeared largely driven by adenocarcinomas. Statistical modeling yielded an estimated mean pre-clinical sojourn time (MPST) of 5.38 [4.76, 5.88] years and a screen-test sensitivity of 81.6 [74.4%, 88.8%] for lung cancer overall, all histologic subtypes combined. Based on modeling, we further estimated that about 48% (47.5% [43.2%, 50.7%]) of screen-detected tumors have a lead time ≥4 years, whereas about 33% (32.8% [28.4%, 36.1%]) have a lead time ≥6 years, 23% (22,6% [18,6%, 25,7%]) ≥8 years, 16% (15.6% [12,2%, 18,3%]) ≥10 years and 11% (10,7% [8,0%, 13,0%]) ≥12 years. The high proportions of tumors with relatively long lead times suggests a major risk of overdiagnosis for individuals with comparatively short remaining life expectancies. This article is protected by copyright. All rights reserved.",2020,"The excess cumulative incidence in the screening arm (N=16) represented 25.4% [95%CI -11.3, 64.3] of screen-detected cancer cases (N=63).","['74 participants were diagnosed with lung cancer in the control arm and 90 in the screening arm: 69 during the active screening period; of which 63 screen-detected and 6 interval cancers', '4052 long-term smokers (2622 men), 50.3-71.9\u2009years of age from the general population around Heidelberg, Germany, comparing five annual rounds of low-dose computed tomography (n=2029) with a control arm without intervention (n=2023']",[],"['excess cumulative incidence', 'mean pre-clinical sojourn time (MPST']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1964473', 'cui_str': 'Sojourn'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",4052.0,0.109361,"The excess cumulative incidence in the screening arm (N=16) represented 25.4% [95%CI -11.3, 64.3] of screen-detected cancer cases (N=63).","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'González Maldonado', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Motsch', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Trotter', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Claus-Peter', 'Initials': 'CP', 'LastName': 'Heussel', 'Affiliation': 'Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Hermann', 'Affiliation': 'Epidemiological Cancer Registry Baden-Württemberg, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Sylke Ruth', 'Initials': 'SR', 'LastName': 'Zeissig', 'Affiliation': 'Cancer Registry of Rhineland-Palatinate, Mainz, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Delorme', 'Affiliation': 'Department of Radiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kaaks', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}]",International journal of cancer,['10.1002/ijc.33295']
2408,32930387,"Nintedanib plus mFOLFOX6 as second-line treatment of metastatic, chemorefractory colorectal cancer: the randomized, placebo-controlled, phase II TRICC-C study (AIO-KRK-0111).","Nintedanib is a triple angiokinase-inhibitor of VEGF-receptor 1-3, FGF-receptor 1-3 and PDGF-receptor-a/-b. Thereby it targets angiogenic escape mechanisms. The TRICC-C trial evaluates the addition of nintedanib to mFOLFOX6 in patients with mCRC. TRICC-C is a randomized controlled, double-blinded, phase II trial in mCRC patients that received a first-line non-oxaliplatin containing chemotherapy. Patients received mFOLFOX6+nintedanib (F+N) (2 x 200 mg p.o./d, d1-d14) or mFOLFOX6+placebo (F+P), in a 1:1 ratio. Primary endpoint was mPFS and secondary overall response rate (ORR), overall survival (OS) and safety. 53 patients (27 F+N; 26 F+P) were randomized between 12/2012 to 5/2016 (scheduled n=180). The trial was terminated prematurely due to slow accrual. The trial did not reach its primary endpoint but mPFS, mOS and disease control rate (DCR) were numerically higher in the F+N arm compared to the F+P arm, however, the difference was not significant (mPFS: F+P: 4.6 mo. vs. F+N: 8.1 mo.; HR 0.65; 95% CI 0.32-1.30; p = 0.2156; mOS: F+P: 9.9 mo. vs. F+N: 17.1 mo.; HR 1.03, 95% CI 0.48-2.23; p = 0.9387; DCR: F+P: 50% vs. F+N: 66,7%; p = 0.2709). Toxicity was moderate and only different for neutropenia (F+P: 11.5%, F+N: 19.2%) and gastrointestinal disorders (F+P: 65.4%, F+N: 84.6%). Final results show safety and a non-significant trend towards improved PFS and DCR for the combination of mFOLFOX6+nintedanib in the 2nd-line therapy of mCRC. This article is protected by copyright. All rights reserved.",2020,Final results show safety and a non-significant trend towards improved PFS and DCR for the combination of mFOLFOX6+nintedanib in the 2nd-line therapy of mCRC.,"['metastatic, chemorefractory colorectal cancer', '53 patients (27 F+N; 26 F+P) were randomized between 12/2012 to 5/2016 (scheduled n=180', 'patients with mCRC']","['mFOLFOX6+nintedanib (F+N) (2 x 200 mg p.o./d, d1-d14) or mFOLFOX6+placebo (F+P', 'mFOLFOX6+nintedanib', 'placebo', 'oxaliplatin containing chemotherapy', 'F+N', 'Nintedanib plus mFOLFOX6']","['mOS', 'Toxicity', 'gastrointestinal disorders', 'PFS and DCR', 'neutropenia', 'mPFS, mOS and disease control rate (DCR', 'mPFS and secondary overall response rate (ORR), overall survival (OS) and safety']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.390038,Final results show safety and a non-significant trend towards improved PFS and DCR for the combination of mFOLFOX6+nintedanib in the 2nd-line therapy of mCRC.,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ettrich', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, DE.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Perkhofer', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, DE.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Private Practice, Onkologie Ravensburg, Ravensburg, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Interdisciplinary Tumor Center, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, Ludwig Maximilians University - Grosshadern, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Internal Medicine II, Klinikum Weimar, Weimar, Germany.'}, {'ForeName': 'Holger F', 'Initials': 'HF', 'LastName': 'Hebart', 'Affiliation': 'Medizinische Klinik, Klinikum Schwäbisch Gmünd, Stauferklinik, Mutlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Herrmann', 'Affiliation': 'Medizinische Klinik, Westküstenklinikum Heide, Heide, Germany.'}, {'ForeName': 'Carla V', 'Initials': 'CV', 'LastName': 'Hannig', 'Affiliation': 'Private Practice, Schwerpunktpraxis Hämatologie/Onkologie, Bottrop, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Büchner-Steudel', 'Affiliation': 'Internal Medicine I, Martin-Luther-University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Güthle', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, DE.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Hermann', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, DE.'}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Berger', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, DE.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Department of Internal Medicine I, Ulm University, Ulm, DE.'}]",International journal of cancer,['10.1002/ijc.33296']
2409,32930513,The impact of communicating personal mental ill-health risk: A randomized controlled non-inferiority trial.,"AIM


Risk algorithms predicting personal mental ill-health will form an important component of digital and personalized preventive interventions, yet it is unknown whether informing people of personal risk may cause unintended harm. This trial evaluated the comparative effect of communicating personal mental ill-health risk profiles on psychological distress.
METHODS


Australian participants using a mood-monitoring app were randomly allocated to receiving their current personal mental ill-health risk profile (n = 119), their achievable personal risk profile (n = 118) or to a control group (n = 118) in which no risk information was communicated, in a non-inferiority trial design. The primary outcome was psychological distress at four-weeks as assessed on the Kessler Psychological Distress Scale.
RESULTS


There was high attrition in the trial with 64% of data missing at follow up. Per-protocol (completer) analysis found that the lower bounds of the confidence intervals of the estimated mean change of the current risk (m = 0.19, 95% CI: -2.59- 2.98) and achievable risk (m = -0.09, 95% CI: -2.84 to 2.66) groups were within the non-inferiority margin of the control group's mean at follow up. Supplementary intention-to-treat analysis using Multivariate Imputation by Chained Equations (MICE) found that 98/100 imputed datasets of the current risk profile group, and all imputed datasets of the achievable risk profile group showed non-inferiority to the control group.
CONCLUSIONS


This study provides preliminary support that providing personal mental health risk profiles does not lead to unacceptable worsening of distress compared to no risk feedback, although this needs to be replicated in a fully powered RCT.",2020,"This study provides preliminary support that providing personal mental health risk profiles does not lead to unacceptable worsening of distress compared to no risk feedback, although this needs to be replicated in a fully powered RCT.","['Australian participants using a mood-monitoring app', 'communicating personal mental ill-health risk']","['receiving their current personal mental ill-health risk profile (n = 119), their achievable personal risk profile', 'communicating personal mental ill-health risk profiles']","['psychological distress', 'Kessler Psychological Distress Scale']","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",119.0,0.114768,"This study provides preliminary support that providing personal mental health risk profiles does not lead to unacceptable worsening of distress compared to no risk feedback, although this needs to be replicated in a fully powered RCT.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Choi', 'Affiliation': 'Central Clinical School, Faculty of Medicine and Health, Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ho', 'Affiliation': 'Central Clinical School, Faculty of Medicine and Health, Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morris', 'Affiliation': 'Central Clinical School, Faculty of Medicine and Health, Centre for Translational Data Science, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Calvo', 'Affiliation': 'Faculty of Engineering, Dyson School of Design Engineering, Imperial College London, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Central Clinical School, Faculty of Medicine and Health, Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.'}]",Early intervention in psychiatry,['10.1111/eip.13038']
2410,32930519,A novel Q-value-based nomogram for single intracorneal ring segment implantation versus standard manufacturer's nomogram combined with accelerated cross-linking for treatment of keratoconus: a randomized controlled trial.,"PURPOSE


To compare the efficacy of implanting a single Keraring segment according to a novel Q-value-based nomogram (QN) to that of segment implantation according to the manufacturer's standard nomogram (SN), for keratoconus treatment.
METHODS


This was a prospective, randomized controlled trial of 104 patients (104 eyes) with Amsler-Krumeich grade 1 or 2 keratoconus, and type 1 or 2 cone asymmetry determined according to manufacturer's classification. They were randomly distributed into two groups: group A patients (n = 52) underwent Keraring implantation according to the SN, and group B patients (n = 52) underwent implantation of a single (210° arc-length) Keraring segment according to the QN. Both treatments were combined with accelerated transepithelial cross-linking, and follow-up was 6 months. Main outcome measures were preoperative and postoperative visual acuity, subjective refraction and corneal topography.
RESULTS


At postoperative month 6, group B exhibited statistically significantly higher values of mean uncorrected distance visual acuity (UDVA), sphere, K2, K-average, K-max and Q-anterior (p = 0.02, 0.01, 0.002, 0.001, 0.0001 and 0.03, respectively) compared to that of group A. However, group A exhibited better refractive cylindrical improvements (p = 0.04). In group A, we documented spontaneous extrusion of one Keraring segment.
CONCLUSION


Single 210° arc-length segment implantation using our objective QN was more efficacious for keratoconus treatment than using the subjective SN. The nomograms were comparable when the Q-anterior value was >-1.00; however, the QN was superior to the SN when the Q-anterior value was ≤-1.00. The QN yielded greater postoperative UDVA and smoother corneal remodelling than did the SN for treatment of grade 1 and 2 keratoconic eyes.",2020,"A. However, group A exhibited better refractive cylindrical improvements (p = 0.04).","[""104 patients (104 eyes) with Amsler-Krumeich grade 1 or 2 keratoconus, and type 1 or 2 cone asymmetry determined according to manufacturer's classification""]",['Keraring implantation according to the SN'],"['refractive cylindrical improvements', 'spontaneous extrusion of one Keraring segment', 'preoperative and postoperative visual acuity, subjective refraction and corneal topography', 'postoperative UDVA and smoother corneal remodelling', 'mean uncorrected distance visual acuity (UDVA), sphere, K2, K-average, K-max and Q-anterior']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}]","[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",104.0,0.0476342,"A. However, group A exhibited better refractive cylindrical improvements (p = 0.04).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Iqbal', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elmassry', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Mounir', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Sohag University, Sohag, Egypt.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Soliman', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Acta ophthalmologica,['10.1111/aos.14611']
2411,32923171,"Adjuvant MUC vaccination with tecemotide after resection of colorectal liver metastases: a randomized, double-blind, placebo-controlled, multicenter AIO phase II trial (LICC).","Resection of colorectal liver metastases (CRLM) is a potential curative treatment for patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD). Although long-term survival improved considerably within the last decades, high recurrence rates of 50-75% after resection remain a major challenge.Tecemotide (L-BLP25) is an antigen-specific cancer vaccine inducing immunity against mucin-1 (MUC1). The LICC trial aimed to improve survival in patients with mCRC after R0/R1 resection of CRLM. LICC was a binational, randomized, double-blind, placebo-controlled, multicenter phase 2 study including patients with R0/R1 resected CRLM without evidence of metastatic disease outside the liver. Co-primary endpoints were recurrence-free survival (RFS) and 3-year overall survival (OS) rate, secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety. In total, 121 patients were 2:1 randomized between Oct 2011 and Dec 2014to receive tecemotide (N=79) or placebo (N=42). Baseline characteristics were well balanced. Median RFS was 6.1 months (95% CI 4.5-8.9) and 11.4 months (95% CI 3.7-21.2) ( P  = .1754), 3-year OS rate 69.1% and 79.1%, median OS 62.8 months and not reached in the tecemotide vs. placebo arm ( P  = .2141), respectively. Cox regression models revealed no dependence of RFS or OS on MUC1 expression. The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each). The LICC trial failed to meet its primary endpoints of significantly improving RFS and OS with tecemotide. However, both arms showed unexpectedly long OS. MUC1 expression was not associated with outcome.EudraCT No: 2011-000218-20Clinical Trial Information: NCT01462513Financial Support: Merck KGaA, Darmstadt, Germany.
Abbreviations


AE: adverse event; CP: cyclophosphamide; CRC: colorectal cancer; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; FU: follow-up; HR: hazard ratio; IHC: immunohistochemical staining; ITT: intention-to-treat; DSMB: Data Safety Monitoring Board; LLD: liver-limited disease; mCRC: metastatic colorectal cancer; MPLA: monophosphoryl lipid; AMRI: magnetic resonance imaging; MUC1: mucin 1; NA: not applicable; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NS: normal saline; NSCLC: non-small-cell lung carcinoma; OS: overall surviva; lPP: per protocol; RAS: Rat sarcoma; RFS: recurrence-free survival; TEAE: treatment-emergent adverse event; UICC: Union for International Cancer Control; US: ultrasound; vs.: versus.",2020,"The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each).","['patients with mCRC after R0/R1 resection of CRLM', 'patients with R0/R1 resected CRLM without evidence of metastatic disease outside the liver', '121 patients were 2:1 randomized between Oct 2011 and Dec 2014to receive', 'patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD', 'colorectal liver metastases', ' 2011-000218-20Clinical Trial Information']","['LICC', 'tecemotide', 'Tecemotide (L-BLP25', 'Adjuvant MUC vaccination with tecemotide', 'saline; NSCLC', 'CP: cyclophosphamide; CRC', 'placebo', 'Resection of colorectal liver metastases (CRLM', 'EudraCT']","['3-year OS rate', 'diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus', 'MUC1 expression', 'recurrence rates', 'recurrence-free survival (RFS) and 3-year overall survival (OS) rate, secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety', 'Median RFS', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C1832016', 'cui_str': 'L-BLP25'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0021845', 'cui_str': 'Perforation of intestine'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",121.0,0.76445,"The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each).","[{'ForeName': 'Carl Christoph', 'Initials': 'CC', 'LastName': 'Schimanski', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Hegewisch-Becker', 'Affiliation': 'Hematological and Oncological Practice Eppendorf (HOPE), Practice for Oncology, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Practice for Hematology and Oncology, Müllheim a.d.R., Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Overkamp', 'Affiliation': 'Oncologianova GmbH Recklinghausen, Recklinghausen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Nordoberpfalz Clinics AG, Weiden i.d.O, Germany.'}, {'ForeName': 'Wolf Otto', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vöhringer', 'Affiliation': 'Department of Hematology and Oncology, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Öllinger', 'Affiliation': 'Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'University Cancer Center Leipzig (UCCL), University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Geißler', 'Affiliation': 'Department of Internal Medicine, Oncology/Hematology, Gastroenterology, Hospital Esslingen GmbH, Esslingen, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schulz-Abelius', 'Affiliation': 'Department of Hematology and Oncology, Hospital Altenburger Land GmbH, Altenburg, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Department of Hematology/Oncology, Klinikum Darmstadt GmbH, Darmstadt, Germany.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schön', 'Affiliation': 'Clinic of Visceral Surgery, Municipal Hospital Karlsruhe gGmbH, Karlsruhe, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster, Salzburg, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Galle', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Hauke', 'Initials': 'H', 'LastName': 'Lang', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital of Mainz, Mainz, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmidtmann', 'Affiliation': 'Institute for Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}]",Oncoimmunology,['10.1080/2162402X.2020.1806680']
2412,32923297,Efficacy of Periarticular Multimodal Drug Injection Without NSAIDs in Elderly Patients With Displaced Femoral Neck Fractures Undergoing Bipolar Hemiarthroplasty: A Prospective Triple-Blinded RCT.,"Introduction Recently, periarticular multimodal drug injection (PMDI) has demonstrated the ability to significantly reduce early postoperative pain with hip fractures in the elderly. Nonetheless, data on PMDI without non-steroidal anti-inflammatory drugs (NSAIDs) in these patients are still doubtful. The current study has evaluated the effect of PMDI with NSAIDs in elderly femoral neck fractures (FNFs) underlying bipolar hip arthroplasty (BHA). Materials and methods A prospective triple-blinded randomized controlled trial (RCT) was conducted in 28 elderly FNFs undergoing BHA. They were randomized into two groups: PMDI group (n=14), which received intraoperative PMDI (50-mL solution of 100-mg bupivacaine, 10-mg morphine, 300-mcg epinephrine, and 750-mg cefuroxime), and a placebo group (n=14), which received only saline solution. The primary outcome was a 10-point visual analog scale (VAS). Secondary outcomes were morphine consumption and cumulative ambulatory score (CAS), postoperative complications, and functional outcomes as a timed up-and-go (TUG) test and Harris hip score (HHS) at two, six, and 12 weeks postoperatively. Results The PMDI group demonstrated a significant reduction in the median VAS at the 48 th  hour postoperatively as compared to the placebo group (P = 0.019), and a non-significant reduction in the median VAS at the 36 th  and 60 th  hours (P = 0.058 and 0.110, respectively) and in a median dosage of morphine consumption on the second postoperative day (P = 0.140). There was no significant difference in postoperative ambulation and functional outcome between both groups (P > 0.05, all). Conclusion The PMDI regimen without NSAIDs is effective for postoperative analgesia on the second postoperative day in elderly FNFs undergoing BHA without any significant difference in functional outcome or postoperative complications.",2020,"The PMDI group demonstrated a significant reduction in the median VAS at the 48 th  hour postoperatively as compared to the placebo group (P = 0.019), and a non-significant reduction in the median VAS at the 36 th  and 60 th  hours (P = 0.058 and 0.110, respectively) and in a median dosage of morphine consumption on the second postoperative day (P = 0.140).","['Elderly Patients With Displaced Femoral Neck Fractures Undergoing Bipolar Hemiarthroplasty', 'elderly femoral neck fractures (FNFs) underlying bipolar hip arthroplasty (BHA', '28 elderly FNFs undergoing BHA']","['saline solution', 'PMDI', 'placebo', 'PMDI with NSAIDs', 'intraoperative PMDI (50-mL solution of 100-mg bupivacaine, 10-mg morphine, 300-mcg epinephrine, and 750-mg cefuroxime', 'periarticular multimodal drug injection (PMDI', 'Periarticular Multimodal Drug Injection Without NSAIDs']","['postoperative ambulation and functional outcome', 'functional outcome or postoperative complications', 'median VAS', 'morphine consumption and cumulative ambulatory score (CAS), postoperative complications, and functional outcomes as a timed up-and-go (TUG) test and Harris hip score (HHS', '10-point visual analog scale (VAS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}]",,0.188186,"The PMDI group demonstrated a significant reduction in the median VAS at the 48 th  hour postoperatively as compared to the placebo group (P = 0.019), and a non-significant reduction in the median VAS at the 36 th  and 60 th  hours (P = 0.058 and 0.110, respectively) and in a median dosage of morphine consumption on the second postoperative day (P = 0.140).","[{'ForeName': 'Jakrapong', 'Initials': 'J', 'LastName': 'Orapin', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Wuttichai', 'Initials': 'W', 'LastName': 'Sutantavibul', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Kulapat', 'Initials': 'K', 'LastName': 'Chulsomlee', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Chavarat', 'Initials': 'C', 'LastName': 'Jarungvittayakon', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Nachapan', 'Initials': 'N', 'LastName': 'Pengrung', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Norachart', 'Initials': 'N', 'LastName': 'Sirisreetreerux', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Noratep', 'Initials': 'N', 'LastName': 'Kulachote', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Tulyapreuk', 'Initials': 'T', 'LastName': 'Tawonsawatruk', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Pongsthorn', 'Initials': 'P', 'LastName': 'Chanplakorn', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}, {'ForeName': 'Paphon', 'Initials': 'P', 'LastName': 'Sa-Ngasoongsong', 'Affiliation': 'Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, THA.'}]",Cureus,['10.7759/cureus.10271']
2413,32923335,Health Education about Rheumatic Heart Disease: A Community-Based Cluster Randomized Trial: Rheumatic Heart Disease Educational Strategies.,"Introduction


The burden of rheumatic heart disease (RHD) is still high in Brazil. Lack of population awareness about the disease limits the efficacy of prevention programs. We aimed to evaluate the effectiveness of education on RHD in schools, comparing the conventional expository teaching method with tablet-based worked examples.
Method


A prospective, cluster randomized trial was conducted over eight months in six randomly selected low-income Brazilian public schools. Each class was considered a cluster (total: 90), being randomized 1:1 to receive one of the educational methods. Pre-test evaluated students' prior knowledge on RHD. Post-tests, 10 days, and three months later, evaluated retention of knowledge.
Results


At total 1,301 students (52% female) completed the study, being 63% from high school. Baseline knowledge about RHD was universally low (average score expository classes [G1] 33.9% vs. worked examples [G2] 32.5%, p = 0.23). A significant but similar improvement was observed in both groups in the immediate post-test (pre- vs. post: p < 0.001): G1 57.5% vs. G2 56.7%, p = 0.69. In the late post-test, a significant 20% worsening was observed in both groups and the final scores were again similar: G1 45.0% vs. G2 45.9%, p = 0.87. Highschool students had higher scores (p < 0.001), and girls had better overall performances than boys (p < 0.001).
Conclusion


The novel technology of tablet-based worked examples had similar results compared with expository classes for RHD education in schools. Both educational processes resulted in modest gains in knowledge, with low retention. More studies are needed to determine if increased knowledge leads to behavioral changes that could reduce RHD burden.
Highlights


In a cluster-randomized trial, two different educational strategies about Rheumatic Heart Disease (RHD) for children - standard expository classes and worked examples based on interactive modules in tablet computers - were compared in public schools of underserved Brazilian neighborhoods.Baseline knowledge was low, and the novel tablet-based technology had similar results compared with traditional teaching for RHD education in schools, with no differences in acquisition and mid-term retention of knowledge.Both educational interventions resulted in similar 71% improvement in the immediate post-test, although with suboptimal retention, with over 20% worsening in three months in both groups.Our data suggests that the optimal strategy for RHD education is yet to be determined, and future studies should be warranted to determine if increased knowledge leads to behavioral changes that could reduce disease burden in endemic areas.",2020,"Baseline knowledge was low, and the novel tablet-based technology had similar results compared with traditional teaching for RHD education in schools, with no differences in acquisition and mid-term retention of knowledge.","['Health Education about Rheumatic Heart Disease', 'eight months in six randomly selected low-income Brazilian public schools', 'At total 1,301 students (52% female) completed the study, being 63% from high school', 'children - standard expository classes and worked examples based on interactive modules in tablet computers - were compared in public schools of underserved Brazilian neighborhoods']",[],"['burden of rheumatic heart disease (RHD', 'retention of knowledge']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}]",[],"[{'cui': 'C0035439', 'cui_str': 'Rheumatic heart disease'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",6.0,0.0397795,"Baseline knowledge was low, and the novel tablet-based technology had similar results compared with traditional teaching for RHD education in schools, with no differences in acquisition and mid-term retention of knowledge.","[{'ForeName': 'Kaciane K B', 'Initials': 'KKB', 'LastName': 'Oliveira', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'Nascimento', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'Beaton', 'Affiliation': ""Cardiology, Children's National Health System, Washington - DC, US.""}, {'ForeName': 'Maria Carmo P', 'Initials': 'MCP', 'LastName': 'Nunes', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': 'José Luiz P', 'Initials': 'JLP', 'LastName': 'Silva', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Rabelo', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Barbosa', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': 'Cássio M', 'Initials': 'CM', 'LastName': 'Oliveira', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': 'Mariana D', 'Initials': 'MD', 'LastName': 'Mata', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte - MG, BR.'}, {'ForeName': 'Waydder Antônio A', 'Initials': 'WAA', 'LastName': 'Costa', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte - MG, BR.'}, {'ForeName': 'Augusto F', 'Initials': 'AF', 'LastName': 'Pereira', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte - MG, BR.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Sable', 'Affiliation': 'The Heart Institute, Cincinnati Childrens Hospital Medical Center, Cincinnati - OH, US.'}, {'ForeName': 'Antonio L P', 'Initials': 'ALP', 'LastName': 'Ribeiro', 'Affiliation': 'Serviço de Cardiologia e Cirurgia Cardiovascular e Centro de Telessaúde do Hospital das Clínicas da UFMG, Belo Horizonte - MG, BR.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Global heart,['10.5334/gh.347']
2414,32923446,Medical Qigong for Mobility and Balance Self-Confidence in Older Adults.,"Background/Objectives:  Physical inactivity, sedentary lifestyle, and impaired neuromuscular function increases fall risk and fractures in our aging population. Mind-body modalities, improve strength, balance and coordination, mitigating these risks. This study examined whether a manualized Medical Qigong protocol measurably improves balance, gait, and health self-confidence among older adults.  Design:  Randomized prospective cohort pre-post study with wait time control.  Setting:  Two martial arts centers in Massachusetts and Arizona.  Participants:  Ninety-five adults age ≥ 50 (mean age 68.6 y.o., range 51-96) were randomly assigned to an immediate start group (N = 53) or 4-week delayed start group ( N  = 43).  Intervention:  A 10 form qigong protocol taught over 12 weekly classes.  Measurments:  Primary outcome measures were the Community Balance and Mobility Scale (CBMS) and Activities-Specific Balance Confidence (ABC) Scale. Data was collected at baseline, 1-month and 4-months.  Results:  Both groups at both sites demonstrated improved balance and gait (CBMS + 11.9 points,  p  < 0.001). This effect was strongest in patients in their 60 s (CBMS +12.9  p  < 0.01) and 70 s (CBMS + 14.3,  p  < 0.001), was equal across genders and socioeconomic status. Balance self-confidence did not significantly change (ABC + 0.9,  p  = 0.48), though several elements within ABC trended toward improvement [e.g., walk up/down ramp ( p  = 0.07), bend over/pick up ( p  = 0.09)]. Falls in the past year was inversely correlated with balance self-confidence ( p  = 0.01).  Conclusion:  A 12-week manualized Medical Qigong protocol significantly improved balance and gait and modestly improved balance self-confidence among older adults. Medical Qigong may be a useful clinical intervention for older adults at heightened risk for falls and related injuries.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT04430751.",2020,"This effect was strongest in patients in their 60 s (CBMS +12.9  p  < 0.01) and 70 s (CBMS + 14.3,  ","['older adults', 'Participants:  Ninety-five adults age ≥ 50 (mean age 68.6 y.o., range 51-96', 'Older Adults', 'older adults at heightened risk for falls and related injuries', 'Setting:  Two martial arts centers in Massachusetts and Arizona']","['Medical Qigong', 'manualized Medical Qigong protocol']","['balance, gait, and health self-confidence', 'Community Balance and Mobility Scale (CBMS) and Activities-Specific Balance Confidence (ABC) Scale', 'balance self-confidence', 'balance and gait', 'strength, balance and coordination', 'Balance self-confidence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0079801', 'cui_str': 'Martial arts'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",95.0,0.0414699,"This effect was strongest in patients in their 60 s (CBMS +12.9  p  < 0.01) and 70 s (CBMS + 14.3,  ","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Stahl', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Section General Internal Medicine, Lebanon, NH, United States.'}, {'ForeName': 'Shoshana S', 'Initials': 'SS', 'LastName': 'Belisle', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Section General Internal Medicine, Lebanon, NH, United States.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Lebanon, NH, United States.'}]",Frontiers in medicine,['10.3389/fmed.2020.00422']
2415,32924086,Adding the Coping Power Programme to parent management training: the cost-effectiveness of stacking interventions for children with disruptive behaviour disorders.,"Parent management training (PMT) programmes and child cognitive behavioural therapy are recommended approaches for treatment of oppositional defiant disorder in children, and combining these may be effective. However, little is known regarding the economic efficiency of this additive effect. A within-trial cost-effectiveness analysis was carried out in Sweden including 120 children aged 8-12 who screened positive for disruptive behaviour disorders, within a psychiatric care setting, and their parents. They were randomly assigned to either the Swedish group-based PMT Comet, or to an enhanced version, where an additional child component was provided, the Coping Power Programme (CPP). Child behaviour problems as well as healthcare and educational resource use were measured at baseline, post-test and at two-year follow-up. A net benefit regression framework was used to estimate differences in costs and health outcomes between the two intervention arms during the two-year period. Comet with CPP cost on average 820 EURO more per family than Comet only. At the 2-year follow-up, there were 37% recovered cases of ODD in Comet with CPP, in comparison to 26% in the Comet only arm. At a willingness-to-pay of approximately 62,300 EURO per recovered case of ODD, Comet with CPP yielded positive net benefits, in comparison to Comet only. Offering children the CPP simultaneously as their parents receive PMT, in comparison to only providing PMT, yields clinically relevant gains. Despite the relatively small cost for CPP, investment in combining PMT and CPP should be guided by resource prioritisation. Trial registration number: ISRCTN10834473, date of registration: 23/12/2015.",2020,"A within-trial cost-effectiveness analysis was carried out in Sweden including 120 children aged 8-12 who screened positive for disruptive behaviour disorders, within a psychiatric care setting, and their parents.","['Sweden including 120 children aged 8-12 who screened positive for disruptive behaviour disorders, within a psychiatric care setting, and their parents', 'oppositional defiant disorder in children', 'children with disruptive behaviour disorders']","['Coping Power Programme to parent management training', 'Parent management training (PMT) programmes and child cognitive behavioural therapy', 'Swedish group-based PMT Comet, or to an enhanced version, where an additional child component was provided, the Coping Power Programme (CPP', 'stacking interventions']",['costs and health outcomes'],"[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012734', 'cui_str': 'Disruptive behavior disorder'}, {'cui': 'C0204523', 'cui_str': 'Psychiatric therapeutic procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",120.0,0.0549503,"A within-trial cost-effectiveness analysis was carried out in Sweden including 120 children aged 8-12 who screened positive for disruptive behaviour disorders, within a psychiatric care setting, and their parents.","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Nystrand', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden. camilla.nystrand@pubcare.uu.se.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Helander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Enebrink', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Sampaio', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01638-w']
2416,32924207,Computer-Delivered Brief Alcohol Intervention for Patients with Liver Disease: A Randomized Controlled Trial.,"BACKGROUND AND AIMS


Reducing alcohol consumption by liver disease patients can reduce morbidity and mortality. This study compared a computer-delivered brief alcohol intervention (cBAI) with standard care in a sample of US military veterans with liver disease.
DESIGN


Multi-site, randomized controlled trial of a cBAI plus standard care (n=67) versus standard care only (n=71). Participants were assessed at baseline and 3- and 6-month follow-up.
SETTING


US Veterans Health Administration liver clinics.
PARTICIPANTS


Participants were mostly male and diagnosed with hepatitis C.
INTERVENTIONS AND COMPARATORS


A cBAI tailored to veterans with liver disease and consisting of assessment and personalized feedback. Standard care was brief education and advice about alcohol and liver disease.
MEASUREMENT


Primary outcomes were self-reported number of drinking days and unhealthy drinking days (defined as >2 drinks for men and >1 for women) in the past 30 days at 6-month follow-up. Secondary outcomes were these two variables at 3-month follow-up, and drinks consumed per drinking day, depression, and overall health at 3- and 6-month follow-ups. Missing data were imputed using multiple imputation.
FINDINGS


Compared with standard care, cBAI participants reported significantly fewer drinking days at 6-month follow-up and fewer unhealthy drinking days at both 3- and 6-months follow-ups. Least Square means (LS-means) for number of drinking days were 3.78 for the cBAI condition and 6.89 for the standard care condition at 6 months (LS-mean ratio=3.78/6.89=0.55, 95% confidence interval [CI] = 0.34, 0.89). LS-means for number of unhealthy drinking days were 1.04 for the cBAI condition and 2.57 for the standard care condition at 3-months follow-up (LS-mean ratio=1.04/2.57=0.41, 95% CI = 0.19, 0.85). At 6-months follow-up, LS-means were 1.18 for the cBAI condition and 2.75 for the standard care condition (LS-mean ratio =1.18/2.75=0.43, 95% CI = 0.20, 0.91).
CONCLUSIONS


A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.",2020,"CONCLUSIONS


A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.","['Participants were mostly male and diagnosed with hepatitis C', 'liver disease patients', 'n=71', 'Patients with Liver Disease', 'military veterans with liver disease', 'US Veterans Health Administration liver clinics']","['Computer-Delivered Brief Alcohol Intervention', 'cBAI plus standard care (n=67) versus standard care only', 'computer-delivered brief alcohol intervention (cBAI) with standard care']","['morbidity and mortality', '3-month follow-up, and drinks consumed per drinking day, depression, and overall health', 'self-reported number of drinking days and unhealthy drinking days (defined as >2 drinks for men and >1 for women']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",,0.062993,"CONCLUSIONS


A computer-delivered brief alcohol intervention reduced drinking days and unhealthy drinking days at 6-month follow up in military veterans with liver disease compared with brief education and advice to reduce consumption.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cucciare', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, AR, 72205, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'Combs', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Joshi', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, 94025, USA.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, AR, 72205, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Humphreys', 'Affiliation': 'Center for Innovation to Implementation, Veterans Affairs Palo Alto Health Care System, Menlo Park, CA, 94025, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15263']
2417,32924240,Clinical Performance of Posterior Inlay-Retained and Wing-Retained Monolithic Zirconia Resin-Bonded Fixed Partial Dentures: Stage One Results of a Randomized Controlled Trial.,"PURPOSE


To prospectively compare the clinical performance of posterior inlay-retained and wing-retained monolithic zirconia fixed partial dentures (FPDs).
MATERIALS AND METHODS


After simple randomization, 30 participants received either one inlay-retained (n = 15; mean age: 56.38 ±12.70 years; 10 men [66.7%]) or one wing-retained (n = 15; mean age: 45.90 ±13.24 years; 7 men [46.7%]) FPD. The restorations, which predominantly replaced first molars, were fabricated from translucent, 3 mol% yttria-stabilized zirconia and attached with self-etching resin cement. Restorations and abutment teeth were clinically followed up for complications one week and 3, 6, and 12 months after cementation. Plaque and gingival scores, probing pocket depths, and attachment levels were recorded for the abutment and contralateral reference teeth both before treatment and during follow-up examinations. The restorations were also assessed in accordance with FDI World Dental Federation criteria. Statistical analyses were conducted with R (α = .05). An adaptive, 2-stage study design based on the incidence of failure-free survival in the groups after 12 months (stage 1) was implemented. Predefined decision rules were used to determine whether further recruitment (stage 2) would enable the detection of a statistically significant difference between the restoration designs with sufficient power.
RESULTS


During 12 months, only one wing retainer debonded which required removal of the FPD. Failure-free survival was thus 93.3% for wing-retained and 100% for inlay-retained FPDs (log-rank test, p = 0.317). Moderate aftercare resulted in intervention-free rates of 78.8% and 86.7% for inlay-retained and wing-retained restorations, respectively (log-rank test, p = 0.605). Based on FDI World Dental Federation criteria, all restorations were acceptable at the 12-month follow-up (Fisher-Boschloo test, p = 0.161). Plaque, gingival, and periodontal scores remained practically unchanged from before treatment to the 12-month follow-up. Recruitment was stopped after stage 1 because, based on the small difference in the incidence of failure-free survival in the groups, it was accepted that it would not be possible to recruit the necessary number of participants to show a statistically significant difference between the retainer designs.
CONCLUSIONS


Both inlay-retained and wing-retained monolithic zirconia resin-bonded FPDs performed well for the 12 month, short term follow up period. This article is protected by copyright. All rights reserved.",2020,"Plaque and gingival scores, probing pocket depths, and attachment levels were recorded for the abutment and contralateral reference teeth both before treatment and during follow-up examinations.",['30 participants received either one inlay-retained (n = 15; mean age: 56.38 ±12.70 years; 10 men [66.7%]) or one wing-retained (n = 15; mean age: 45.90 ±13.24 years; 7 men [46.7%]) FPD'],"['Posterior Inlay-Retained and Wing-Retained Monolithic Zirconia Resin-Bonded Fixed Partial Dentures', 'posterior inlay-retained and wing-retained monolithic zirconia fixed partial dentures (FPDs']","['Plaque and gingival scores, probing pocket depths, and attachment levels', 'Plaque, gingival, and periodontal scores', 'intervention-free rates', 'incidence of failure-free survival', 'Failure-free survival']","[{'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517843', 'cui_str': '66.7'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0085071', 'cui_str': 'Maryland bridge'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.150442,"Plaque and gingival scores, probing pocket depths, and attachment levels were recorded for the abutment and contralateral reference teeth both before treatment and during follow-up examinations.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bömicke', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Rathmann', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Pilz', 'Affiliation': 'Department of Medical Biometry, Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Justo Lorenzo', 'Initials': 'JL', 'LastName': 'Bermejo', 'Affiliation': 'Department of Medical Biometry, Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Waldecker', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Ohlmann', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rammelsberg', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zenthöfer', 'Affiliation': 'Department of Prosthetic Dentistry, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13258']
2418,32924256,Evaluation of intralesional Candida antigen in diabetic patients with multiple warts.,"BACKGROUND


Treatment of warts in diabetic patients with ablative modalities poses a significant risk owing to increased possibility of secondary infection, slow healing and recurrence. Intralesional immunotherapy has gained popularity in the treatment of warts due to its proven efficacy and good tolerability compared to destructive methods.
OBJECTIVES


We aim to evaluate intralesional Candida antigen injection for the treatment of multiple warts in diabetic patients.
METHODS


Fifty diabetic patients with multiple genital / non-genital warts were divided into 2 groups. The first group (30 patients) received intralesional Candida antigen and the second group (20 patients) had intralesional saline as control. The treatments were injected into the largest wart every 2 weeks until complete clearance of warts or for a maximum of 5 sessions.
RESULTS


Complete clearance of warts was observed in 80% of the diabetic patients in the Candida antigen group compared to 15% in the control group (p<0.001). Side effects to Candida antigen included pain during injection in all patients, flu-like symptoms and localized reaction at the injection site in few patients.
CONCLUSION


Intralesional Candida antigen injection can be a promising effective and safe therapeutic option for the treatment of warts in diabetic patients.",2020,"Side effects to Candida antigen included pain during injection in all patients, flu-like symptoms and localized reaction at the injection site in few patients.
","['warts in diabetic patients', 'multiple warts in diabetic patients', 'Fifty diabetic patients with multiple genital / non-genital warts', 'diabetic patients', 'diabetic patients with multiple warts']","['intralesional Candida antigen injection', 'intralesional Candida antigen', 'Intralesional Candida antigen injection', 'Intralesional immunotherapy', 'intralesional saline']","['pain', 'Complete clearance of warts']","[{'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0856325', 'cui_str': 'Non-genital warts NOS'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]",50.0,0.0194649,"Side effects to Candida antigen included pain during injection in all patients, flu-like symptoms and localized reaction at the injection site in few patients.
","[{'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Marei', 'Affiliation': 'Microbiology and Immunology department, Faculty of Medicine, Zagazig University.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Alakad', 'Affiliation': 'Interventional research lab, Interventional Immunology and Allergy Center, Zagazig, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Wahid', 'Affiliation': 'Physiology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13718']
2419,32919703,mTOR - Mediated protein synthesis by inhibiting protein catabolism in Chinese perch (Siniperca chuatsi).,"Activation of the mechanistic target of rapamycin (mTOR) pathway is known to promote protein synthesis by enhancing mRNA translation. However, there have been few literatures on the effect of mTOR on protein metabolism in non-mammals. The main source of ammonia in fish comes from protein catabolism. The key step of protein catabolism involves the deamination and/or transamination of amino acids. This study is aimed to explore the mechanism underlying mTOR pathway influencing protein retention from the perspective of protein catabolism. Chinese perch were fasted for 24 h and divided into 4 groups randomly before intracerebroventricular (ICV) injection: (1) control group for leucine; (2) leucine group; (3) control group for leucine and rapamycin; (4) leucine and rapamycin group. Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection). Ammonia-N excretion rate, blood glucose, S6 phosphorylation level, and expression of relative genes of protein catabolism (GDH, AMPD, AST, ALT) were determined. The results indicated that the pS6 level was increased, and that the ammonia-N excretion rate, blood glucose, and mRNA level of protein catabolism genes (GDH and AMPD) were significantly decreased after injection with leucine, while those changes were reversed after injection with leucine and rapamycin. Our study not only reveals the mechanism by which mTOR mediates protein synthesis by inhibiting protein catabolism in Chinese perch, but also provides reference for improving the utilization of feed protein.",2020,"Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection).",[],"['intracerebroventricular (ICV) injection: (1) control group for leucine; (2) leucine group; (3) control group for leucine and rapamycin; (4) leucine and rapamycin group', 'leucine and rapamycin', 'rapamycin']","['ammonia-N excretion rate, blood glucose, and mRNA level of protein catabolism genes (GDH and AMPD', 'pS6 level', 'Food intake', 'Ammonia-N excretion rate, blood glucose, S6 phosphorylation level, and expression of relative genes of protein catabolism (GDH, AMPD, AST, ALT']",[],"[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0135621,"Food intake was equivalent between each control and treatment groups at each time point (0.5, 4, 12 and 24 h post-injection).","[{'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Yanpeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Xu-Fang', 'Initials': 'XF', 'LastName': 'Liang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China. Electronic address: xufang_liang@hotmail.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Shulin', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'College of Fisheries, Chinese Perch Research Center, Huazhong Agricultural University, Wuhan, 430070, China; Key Lab of Freshwater Animal Breeding, Ministry of Agriculture and Rural Affair/ Hubei Engineering Technology Research Center for Fish Breeding and Healthy Aquaculture, Wuhan, 430070, China.'}]",Biochemical and biophysical research communications,['10.1016/j.bbrc.2020.08.107']
2420,32919776,Commentary: The ISCHEMIA trial: Throwing the baby out with the bathwater?,,2020,,[],[],[],[],[],[],,0.017903,,"[{'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Grimm', 'Affiliation': 'Division of Cardiac Surgery, The University of Pennsylvania School of Medicine, Philadelphia, Pa.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, The University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address: kilica2@upmc.edu.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.08.010']
2421,32919816,Effect of monthly vitamin D on diverticular disease hospitalization: Post-hoc analysis of a randomized controlled trial.,"BACKGROUND & AIMS


Some studies have linked low vitamin D status and high risk of diverticular disease, but the causal relationship between vitamin D and diverticular disease remains unclear; clinical trial data are warranted. The objective was to assess the efficacy of vitamin D 3  supplementation on diverticular disease hospitalization.
METHODS


Post-hoc analysis of a community-based randomized double-blind placebo-controlled trial (RCT) with 5108 participants randomized to receive monthly 100,000 IU vitamin D (n = 2558) or identical placebo (n = 2550). The outcome was time to first diverticular disease hospitalization from randomization to the end of intervention (July 2015), including a prespecified subgroup analysis in participants with baseline deseasonalized 25-hydroxyvitamin D (25(OH)D) levels < 50 nmol/L.
RESULTS


Over a median of 3.3 years follow-up, 74 participants had diverticular disease hospitalization. There was no difference in the risk of diverticular disease hospitalization between vitamin D supplementation (35/2558 = 1.4%) and placebo (39/2550 = 1.5%) groups (adjusted hazard ratio (HR) = 0.90; p = 0.65), although in participants with deseasonalized 25(OH)D < 50 nmol/L (n = 1272), the risk was significantly lower in the vitamin D group than placebo (HR = 0.08, p = 0.02).
DISCUSSION


Monthly 100,000 IU vitamin D 3  does not reduce the risk of diverticular disease hospitalization in the general population. Further RCTs are required to investigate the effect of vitamin D supplementation on the diverticular disease in participants with low 25(OH)D levels.",2020,"There was no difference in the risk of diverticular disease hospitalization between vitamin D supplementation (35/2558 = 1.4%) and placebo (39/2550 = 1.5%) groups (adjusted hazard ratio (HR) = 0.90; p = 0.65), although in participants with deseasonalized 25(OH)D ","['participants with low 25(OH)D levels', '5108 participants randomized to receive monthly 100,000']","['vitamin D supplementation', 'vitamin D 3  supplementation', 'placebo', 'IU vitamin D (n\xa0=\xa02558) or identical placebo', 'monthly vitamin D']","['diverticular disease hospitalization', 'time to first diverticular disease hospitalization', 'risk of diverticular disease hospitalization', 'baseline deseasonalized 25-hydroxyvitamin D (25(OH)D) levels']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1510475', 'cui_str': 'Diverticula of intestine'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5108.0,0.680732,"There was no difference in the risk of diverticular disease hospitalization between vitamin D supplementation (35/2558 = 1.4%) and placebo (39/2550 = 1.5%) groups (adjusted hazard ratio (HR) = 0.90; p = 0.65), although in participants with deseasonalized 25(OH)D ","[{'ForeName': 'Zhenqiang', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand; Department of Geriatric Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'Department of Geriatric Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sluyter', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Waayer', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand. Electronic address: r.scragg@auckland.ac.nz.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.030']
2422,32919819,Six-month outcomes after individualized nutritional support during the hospital stay in medical patients at nutritional risk: Secondary analysis of a prospective randomized trial.,"BACKGROUND


Among medical inpatients at risk of malnutrition, the use of individualized nutritional support during the hospital stay was found to reduce complications and improve mortality at short-term. We evaluated clinical outcomes at 6-months follow-up.
METHODS


We randomly assigned 2028 patients to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or hospital food as usual (control group) during the hospital stay. The intervention was discontinued at hospital discharge and further nutritional support was based on the discretion of the treating team. We had complete follow-up information of 1995 patients (98%), which were included in the final analysis. The primary endpoint was all-cause mortality at 6-months. Prespecified secondary end points included non-elective hospital readmissions, functional outcome and quality of life.
RESULTS


At 6-month, 231 of 994 (23.2%) intervention group patients had died compared to 246 of 999 (24.6%) control group patients, resulting in a hazard ratio for death of 0.90 (95%CI 0.76 to 1.08, p = 0.277). Compared to control patients, intervention group patients had similar rates of hospital readmission (27.3% vs. 27.6%, HR 1.00 (95%CI 0.84 to 1.18), p = 0.974), falls (11.2% vs. 10.9%, HR 0.96 (95%CI 0.72 to 1.27), p = 0.773) and similar quality of life and activities of daily living scores.
INTERPRETATION


While individualized nutritional support during the hospital stay significantly reduced short-term mortality, there was no legacy effect on longer term outcomes. Future trials should investigate whether continuation of nutritional support after hospital discharge reduces the high malnutrition-associated mortality rates in this vulnerable patient population.
TRIAL REGISTRATION


ClinicalTrials.gov number, NCT02517476.",2020,"Compared to control patients, intervention group patients had similar rates of hospital readmission (27.3% vs. 27.6%, HR 1.00 (95%CI 0.84 to 1.18), p = 0.974), falls (11.2% vs. 10.9%, HR 0.96 (95%CI 0.72 to 1.27), p = 0.773) and similar quality of life and activities of daily living scores.
","['2028 patients to receive', 'medical patients at nutritional risk', 'medical inpatients at risk of malnutrition']","['individualized nutritional support', 'protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or hospital food as usual (control group']","['hazard ratio for death', 'cause mortality', 'non-elective hospital readmissions, functional outcome and quality of life', 'quality of life and activities of daily living scores', 'died', 'rates of hospital readmission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2028.0,0.136654,"Compared to control patients, intervention group patients had similar rates of hospital readmission (27.3% vs. 27.6%, HR 1.00 (95%CI 0.84 to 1.18), p = 0.974), falls (11.2% vs. 10.9%, HR 0.96 (95%CI 0.72 to 1.27), p = 0.773) and similar quality of life and activities of daily living scores.
","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kaegi-Braun', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Department of Health Professions, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; The New York Academy of Sciences, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fehr', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Baechli', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Geiser', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Deiss', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bregenzer', 'Affiliation': 'Internal Medicine, Spital Lachen, Switzerland.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hoess', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Switzerland.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Pavlicek', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bilz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sigrist', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brändle', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Benz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henzen', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mattmann', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thomann', 'Affiliation': 'Internal Medicine, Bürgerspital Solothurn, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Internal Medicine, Kantonsspital Baselland, Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': ""Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetology, Endocrinology, Nutritional Medicine & Metabolism, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland. Electronic address: schuetzph@gmail.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.019']
2423,32919855,Stereoscopic Display Is Superior to Conventional Display for Three-Dimensional Echocardiography of Congenital Heart Anatomy.,"BACKGROUND


Three-dimensional echocardiography (3DE) improves visualization of cardiac lesions. Current viewing of 3DE studies on a conventional display diminishes the encoded stereoscopic (stereo) information for depth perception. This study aims to evaluate clinician subjective and objective experience of stereo display compared with nonstereo display of 3DE in congenital heart disease.
METHODS


In this prospective study, 22 cardiologists, advanced cardiology trainees, and cardiothoracic surgeons used a commercially available stereo display system with proprietary software to view 10 3DE data sets, alternating between simple and complex lesions. In part A, participants viewed each data set, randomized to 1 minute of stereo display followed by 1 minute of nonstereo display, or vice versa. In part B, participants could freely toggle between stereo and nonstereo display for an additional 90 seconds per data set. Participants answered a series of questions and rated their subjective experience using stereo versus nonstereo display mode on a Likert scale. Objective data on time spent in each display mode during part B and duration of interaction and degree of movement of the 3DE data set in parts A and B were also collected.
RESULTS


All clinician groups found stereo display preferable to nonstereo display of 3DE (P < .0001). Viewing complex lesions was rated lower than simple lesions when using nonstereo display (P < .01). Simple and complex lesions were equally well rated when using stereo display (P = .14). When given a choice of display modes in part B, participants spent more time in stereo display (P < .0001) and interacted more with the 3DE data sets in stereo display (P < .0001).
CONCLUSIONS


Interactive stereoscopic display of 3DE was preferred over conventional nonstereo display by all clinician groups for viewing both simple and complex lesions. This preference is especially true for viewing complex lesions.",2020,"When given a choice of display modes in part B, participants spent more time in stereo display (P < .0001) and interacted more with the 3DE data sets in stereo display (P < .0001).
","['22 cardiologists, advanced cardiology trainees, and cardiothoracic surgeons']","['dimensional echocardiography (3DE', 'nonstereo display of 3DE']",['visualization of cardiac lesions'],"[{'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0586887', 'cui_str': 'Cardiothoracic surgeon'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.029019,"When given a choice of display modes in part B, participants spent more time in stereo display (P < .0001) and interacted more with the 3DE data sets in stereo display (P < .0001).
","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Harake', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Ganesh Kumar', 'Initials': 'GK', 'LastName': 'Gnanappa', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Silvia G V', 'Initials': 'SGV', 'LastName': 'Alvarez', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whittle', 'Affiliation': 'Radiology and Diagnostic Imaging, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kumaradevan', 'Initials': 'K', 'LastName': 'Punithakumar', 'Affiliation': 'Radiology and Diagnostic Imaging, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Boechler', 'Affiliation': 'Educational Psychology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Noga', 'Affiliation': 'Radiology and Diagnostic Imaging, University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Nee Scze', 'Initials': 'NS', 'LastName': 'Khoo', 'Affiliation': ""Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada. Electronic address: harake@ualberta.ca.""}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2020.06.016']
2424,32920135,"Therapeutic effects of andiroba (Carapa guianensis Aubl) oil, compared to low power laser, on oral mucositis in children underwent chemotherapy: A clinical study.","ETHNO-PHARMACOLOGICAL RELEVANCE


The Carapa guianensis Aubl, popularly known as andiroba, is a large tree of the Meliaceae family, commonly found in the Amazon region. The oil extracted from its seeds is recognized in traditional medicine and has high anti-inflammatory and analgesic potential, which are the basic prerequisites for a therapeutic agent that can be used in the treatment of oral mucositis (OM). Moreover, the aforementioned oil has antimicrobial, antiallergic, and parasiticidal actions and is effective in the management of cutaneous and muscular dysfunctions.
AIM OF THE STUDY


To evaluate the therapeutic effects of andiroba gel (Carapa guianensis Aubl) on the symptomatology and evolution of OM in children with leukemia who underwent chemotherapy and to compare it to the effects of low power laser.
MATERIALS AND METHODS


This randomized, double-blind clinical trial involved 60 patients of both genders with leukemia, with age ranging from six to twelve years. The patients were divided into two study groups: the andiroba group (n = 30) and the laser group (n = 30). The level of pain experienced by the patients was assessed using the Wong-Baker visual analog scale and the degree of severity of OM was assessed using a table, recommended by the World Health Organization, that depicts the degrees of severity of OM. The data obtained were analyzed using the Mann-Whitney test, with statistical significance indicated by a P value less than or equal to 0.05.
RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
CONCLUSIONS


The use of andiroba oil effectively reduced the severity of OM and relieved pain, which resulted in a decrease in the severity of signs and symptoms in the patients in the andiroba group, compared to the laser group.",2020,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","['children underwent', 'children with leukemia who underwent', '60 patients of both genders with leukemia, with age ranging from six to twelve years']","['andiroba gel (Carapa guianensis Aubl', 'chemotherapy', 'andiroba (Carapa guianensis Aubl) oil']","['Baker visual analog scale and the degree of severity of OM', 'degree of OM', 'severity of OM and relieved pain', 'level of pain', 'pain scores', 'severity of signs and symptoms', 'oral mucositis', 'symptomatology and evolution of OM']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1258042', 'cui_str': 'Carapa'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441982', 'cui_str': 'Degrees of severity'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",60.0,0.0241249,"RESULTS


A statistically significant reduction in the degree of OM was observed on the fourth, fifth, and sixth days and in the pain scores on the second, third, and fourth days in the andiroba group after the manifestation of OM, compared to the laser group.
","[{'ForeName': 'Artur Dos Santos', 'Initials': 'ADS', 'LastName': 'Soares', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: artur_soares_@hotmail.com.'}, {'ForeName': 'Ana Marcia', 'Initials': 'AM', 'LastName': 'Viana Wanzeler', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: marciawanzeler@hotmail.com.'}, {'ForeName': 'Gabriel Henrique', 'Initials': 'GH', 'LastName': 'Soares Cavalcante', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil. Electronic address: gabrielhscavalcante@gmail.com.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Maria da Silva Barros', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: elsabarros12345@gmail.com.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'de Cássia Matos Carneiro', 'Affiliation': 'Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: ritacarneiro69@yahoo.com.br.'}, {'ForeName': 'E Fabrício Mesquita', 'Initials': 'EFM', 'LastName': 'Tuji', 'Affiliation': 'Department of Odontology, Federal University of Pará, Street Augusto Corrêa, Number 01, 66075-110, Belém, PA, Brazil; Radiotherapy Service of Hospital Ophir Loyola, Avenue. Gov Magalhães Barata, Number 992, 66060-281, Belém, PA, Brazil. Electronic address: fmtuji@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113365']
2425,32920164,Building resilience to body image triggers using brief cognitive training on a mobile application: A randomized controlled trial.,"OBJECTIVE


Body image disturbance (BID) is common among women, characterized by persistent and distressing appearance dissatisfaction, and linked with eating disorders. Although effective, cognitive behavioral therapy (CBT) delivered by trained professionals is not easily accessible. This randomized trial evaluated the effects of a CBT-based mobile application designed to increase resilience to body image triggers and reduce BID symptoms.
METHOD


A non-clinical sample of women (N = 90; M age  = 23.52) was randomized to use the mobile application for approximately 4 min of daily exercises for two weeks or to a control condition. Body image was measured at baseline, immediately after two weeks of mobile application use, and at 1-month follow-up. To examine whether using the application was associated with increased resilience to common BID triggers, participants completed an Instagram exposure resilience task upon completion and at 1-month follow-up.
RESULTS


Relative to those in the control condition, participants who used the application demonstrated increased resiliency and reduced BID symptoms. Theses effects were medium-to-large and were maintained at 1-month follow-up.
CONCLUSION


These results underscore the potential usefulness of brief, low-intensity, portable interventions in reducing BID symptoms and in increasing resilience to thin-ideal body messages often portrayed on social media.",2020,"Relative to those in the control condition, participants who used the application demonstrated increased resiliency and reduced BID symptoms.",['A non-clinical sample of women (N\xa0=\xa090; M age \xa0=\xa023.52'],"['cognitive training', 'cognitive behavioral therapy (CBT', 'CBT-based mobile application']","['Body image', 'resiliency and reduced BID symptoms']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0449784,"Relative to those in the control condition, participants who used the application demonstrated increased resiliency and reduced BID symptoms.","[{'ForeName': 'Dinur', 'Initials': 'D', 'LastName': 'Aboody', 'Affiliation': ""Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, 8 Ha'universuta St. Herzliya, 46150, Israel. Electronic address: dinur@me.com.""}, {'ForeName': 'Jedidiah', 'Initials': 'J', 'LastName': 'Siev', 'Affiliation': 'Department of Psychology, Swarthmore College, 500 College Ave, Swarthmore, PA, 19081, United States. Electronic address: jsiev1@swarthmore.edu.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': ""Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, 8 Ha'universuta St. Herzliya, 46150, Israel. Electronic address: gdoron@idc.ac.il.""}]",Behaviour research and therapy,['10.1016/j.brat.2020.103723']
2426,32921872,[Prognostic implications of myocardial injury in patients with and without COVID-19 infection treated in a university hospital].,"INTRODUCTION AND OBJECTIVES


Cardiac troponin, a marker of myocardial injury, is frequently observed in patients with COVID-19 infection. Our objective was to analyze myocardial injury and its prognostic implications in patients with and without COVID-19 infection treated in the same period of time.
METHODS


The present study included patients treated in a university hospital with cardiac troponin I measurements and with suspected COVID-19 infection, confirmed or ruled out by polymerase chain reaction analysis. The impact was analyzed of cardiac troponin I positivity on 30-day mortality.
RESULTS


In total, 433 patients were distributed among the following groups: confirmed COVID-19 (n = 186), 22% with myocardial injury (n = 41); and ruled out COVID-19 (n = 247), 21.5% without myocardial injury (n = 52). The confirmed and ruled out COVID-19 groups had a similar age, sex, and cardiovascular history. Mortality was significantly higher in the confirmed COVID-19 group than in the ruled out group (19.9% vs 5.3%, P < .001). In Cox multivariate regression analysis, cardiac troponin I was a predictor of mortality in both groups (confirmed COVID-19 group: HR, 3.54; 95%CI, 1.70-7.34; P = .001; ruled out COVID-19 group: HR, 5.57; 95%CI, 1.70-18.20; P = .004). The predictive model analyzed by ROC curves was similar in the 2 groups (P = .701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
CONCLUSIONS


Myocardial injury is detected in 1 in every 5 patients with confirmed or ruled out COVID-19 and predicts 30-day mortality to a similar extent in both circumstances.",2020,"The predictive model analyzed by ROC curves was similar in the 2 groups (P = .701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
","['patients with COVID-19 infection', 'patients treated in a university hospital with cardiac troponin', '433 patients were distributed among the following groups: confirmed COVID-19 (n\u2009=\u2009186), 22% with myocardial injury (n\u2009=\u200941); and ruled out COVID-19 (n\u2009=\u2009247), 21.5% without myocardial injury (n\u2009=\u200952', 'patients with and without COVID-19 infection treated in the same period of time', 'patients with and without COVID-19 infection treated in a university hospital']",[],"['Mortality', 'cardiac troponin', '30-day mortality', 'ROC curves', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",433.0,0.232322,"The predictive model analyzed by ROC curves was similar in the 2 groups (P = .701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Bardají', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Carrasquer', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Sánchez-Giménez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Lal-Trehan', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Del-Moral-Ronda', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Óscar M', 'Initials': 'ÓM', 'LastName': 'Peiró', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Bonet', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Gislaine', 'Initials': 'G', 'LastName': 'Castilho', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fort-Gallifa', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Benavent', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Recio', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gutiérrez', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Villavicencio', 'Affiliation': 'Servicio de Cuidados Intensivos, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Auguet', 'Affiliation': 'Universidad Rovira Virgili, Tarragona, España.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Boqué', 'Affiliation': 'Universidad Rovira Virgili, Tarragona, España.'}]",Revista espanola de cardiologia,['10.1016/j.recesp.2020.08.009']
2427,32921876,Estimating the fraction of unreported infections in epidemics with a known epicenter: An application to COVID-19.,"We develop an analytically tractable method to estimate the fraction of unreported infections in epidemics with a known epicenter and estimate the number of unreported COVID-19 infections in the U.S. during the first half of March 2020. Our method utilizes the covariation in initial reported infections across U.S. regions and the number of travelers to these regions from the epicenter, along with the results of an early randomized testing study in Iceland. Using our estimates of the number of unreported infections, which are substantially larger than the number of reported infections, we also provide estimates for the infection fatality rate using data on reported COVID-19 fatalities from U.S. counties.",2020,We develop an analytically tractable method to estimate the fraction of unreported infections in epidemics with a known epicenter and estimate the number of unreported COVID-19 infections in the U.S. during the first half of March 2020.,[],[],[],[],[],[],,0.031995,We develop an analytically tractable method to estimate the fraction of unreported infections in epidemics with a known epicenter and estimate the number of unreported COVID-19 infections in the U.S. during the first half of March 2020.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hortaçsu', 'Affiliation': 'Kenneth C. Griffin Department of Economics, University of Chicago, United States of America.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Kenneth C. Griffin Department of Economics, University of Chicago, United States of America.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Schwieg', 'Affiliation': 'Becker Friedman Institute, United States of America.'}]",Journal of econometrics,['10.1016/j.jeconom.2020.07.047']
2428,32921908,Long-Term Safety and Efficacy of Fractional CO 2  Laser Treatment in Post-Menopausal Women with Vaginal Atrophy.,"Background and Aim


We have previously reported improvement of clinical symptoms of genitourinary syndrome of menopause (GSM) at 3 and 6 months following three CO 2  laser treatments. The current paper presents the results of long term follow up at 12, 15- and 18-months post laser treatment.
Methods


Twenty subjects (mean age 60.65 ± 6.34 years) who had completed the core study participated in follow-up. Subjects were evaluated at 12, 15, and 18 months following final laser therapy. An optional maintenance treatment was offered during Month 12 and Month 15 to those women who failed to increase their Vaginal Health Index Score (VHIS) by more than 34% from their individual baseline, or if the subject desired an additional treatment. At each study visit, VHIS and vulvovaginal atrophy (VVA) symptom severity were recorded. Sexual function was assessed using the Female Sexual Function Index (FSFI).
Results


Fifteen subjects were eligible for a single maintenance treatment (N = 2, at 12 months, and N = 13 at 15 Months). The mean VHIS (± standard deviation) remained significantly improved at 12 months following their last laser treatment (16.3 ± 4.5 vs. Baseline 12.4 ± 4.0; p < 0.05) and at the 15- and 18-months follow up visits as well (16.9 ± 4.6 and 17.1 ± 4.6, respectively; p < 0.05 compared to Baseline). Almost all VVA symptoms were significantly improved at 12 months following the third treatment compared to Baseline and this improvement was sustained at 15 and 18 months. At the 12 Months visit, the total FSFI score increased significantly (N = 15, 24.4 ± 6.9; p < 0.05), and at the 15- and 18-month follow-up visits, the total FSFI remained significantly higher than Baseline (22.2 ± 6.7, 25.8 ± 6.6).
Conclusion


Fractional CO 2  laser treatments are effective in alleviating symptoms of VVA and sexual dysfunction in post-menopausal women, and that effects are sustained over the long-term.",2019,Almost all VVA symptoms were significantly improved at 12 months following the third treatment compared to Baseline and this improvement was sustained at 15 and 18 months.,"['Methods\n\n\nTwenty subjects (mean age 60.65 ± 6.34 years) who had completed the core study participated in follow-up', 'Fifteen subjects were eligible for a single maintenance treatment (N = 2, at 12 months, and N = 13 at 15 Months', 'Post-Menopausal Women with Vaginal Atrophy']",['Fractional CO 2  Laser Treatment'],"['total FSFI score', 'total FSFI', 'Vaginal Health Index Score (VHIS', 'VVA symptoms', 'alleviating symptoms of VVA and sexual dysfunction', 'VHIS and vulvovaginal atrophy (VVA) symptom severity', 'Female Sexual Function Index (FSFI', 'mean VHIS (± standard deviation', 'Sexual function']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",15.0,0.0226172,Almost all VVA symptoms were significantly improved at 12 months following the third treatment compared to Baseline and this improvement was sustained at 15 and 18 months.,"[{'ForeName': 'Scott Evan', 'Initials': 'SE', 'LastName': 'Eder', 'Affiliation': ""The Center for Women's Health & Wellness LLC, Lawrenceville, New Jersey, USA.""}]",Laser therapy,['10.5978/islsm.19-OR-06']
2429,32930994,"Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN).","PURPOSE


To evaluate secondary outcomes including changes in functioning and disability associated with galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, in patients with chronic migraine.
METHODS


Patients randomly received galcanezumab (120 mg n = 278, 240 mg n = 277) or placebo (n = 558) during 3 months of double-blind treatment, followed by a 9-month open-label extension. The Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQv2.1) measured the impact of migraine on patient functioning. The Migraine Disability Assessment (MIDAS) quantified headache-related disability. Changes from baseline were analyzed with mixed model repeated measures or analysis of covariance.
RESULTS


Total MSQ score at baseline was 44.88 ± 18.02 (mean ± SD), indicating significant functional impairment. At Month 3, least squares (LS) mean change ± SE in total MSQ for galcanezumab-treated patients were 20.51 ± 1.49 (120 mg) and 20.49 ± 1.49 (240 mg), both statistically significantly greater vs placebo-treated patients (14.55 ± 1.21; both P < 0.001). Total MIDAS score at baseline was 67.24 ± 57.31 (mean ± SD). At Month 3, LS mean change ± SE from baseline in total MIDAS for galcanezumab-treated patients was statistically significantly greater than placebo for 120 mg group (placebo: - 11.53 ± 3.38 vs 120 mg: - 20.27 ± 4.07; P < 0.05) but not for 240 mg group (- 17.02 ± 4.05). At Month 12, within-group mean changes from baseline for total MSQ (28.56 ± 1.19 previous placebo; 29.53 ± 1.51 previous 120 mg; 25.83 ± 1.49 previous 240 mg) and MIDAS scores (- 28.47 ± 2.95 previous placebo; - 31.47 ± 3.69 previous 120 mg; - 31.13 ± 3.62 previous 240 mg) were statistically significant (P < 0.001) for the open-label treatment population regardless of previous double-blind treatment assignment.
CONCLUSIONS


Galcanezumab-treated patients with chronic migraine reported statistically significant improvements in functioning and disability, representing a clinically significant change.
TRIAL REGISTRATION


ClinicalTrials.gov registry: NCT02614261. Registered 25 November 2015.",2020,"At Month 12, within-group mean changes from baseline for total MSQ (28.56 ± 1.19 previous placebo; 29.53 ± 1.51 previous 120 mg; 25.83 ± 1.49 previous 240 mg) and MIDAS scores (- 28.47 ± 2.95 previous placebo; - 31.47 ± 3.69 previous 120 mg; - 31.13 ± 3.62 previous 240 mg) were statistically significant (P < 0.001) for the open-label treatment population regardless of previous double-blind treatment assignment.
","['patients with chronic migraine', 'patient functioning and disability']","['galcanezumab', 'placebo', 'galcanezumab (120\xa0mg n\u2009=\u2009278, 240\xa0mg n\u2009=\u2009277) or placebo']","['total MSQ', 'functioning and disability', 'Total MIDAS score', 'Migraine Disability Assessment (MIDAS) quantified headache-related disability', 'MIDAS scores', 'Total MSQ score', 'LS mean change\u2009±\u2009SE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.556065,"At Month 12, within-group mean changes from baseline for total MSQ (28.56 ± 1.19 previous placebo; 29.53 ± 1.51 previous 120 mg; 25.83 ± 1.49 previous 240 mg) and MIDAS scores (- 28.47 ± 2.95 previous placebo; - 31.47 ± 3.69 previous 120 mg; - 31.13 ± 3.62 previous 240 mg) were statistically significant (P < 0.001) for the open-label treatment population regardless of previous double-blind treatment assignment.
","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA. ford_janet@lilly.com.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tassorelli', 'Affiliation': 'IRCCS C. Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Leroux', 'Affiliation': 'Department of Clinical Neuroscience, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ayer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Nichols', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Holland', 'Initials': 'H', 'LastName': 'Detke', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02623-1']
2430,32931029,Impact of adjuvant trastuzumab on locoregional failure rates in a randomized clinical trial: North Central Cancer Treatment Group N9831 (alliance) study.,"BACKGROUND


The goal of this study was to assess the impact of trastuzumab on locoregional failure.
METHODS


The analysis included 2763 patients with HER2-positive (HER2+) breast cancer who were randomly assigned to adjuvant doxorubicin (A), cyclophosphamide (C), paclitaxel (T) and trastuzumab (H) (arm A, AC→T [n = 922]; arm B, AC→T→H [n = 988]; arm C, AC→T+H→H [n = 853]). Radiotherapy was given after AC→T concurrently with H. Radiotherapy was given after lumpectomy (L) or after mastectomy (M) with ≥4 positive lymph nodes but was optional for 1 to 3 positive lymph nodes. Locoregional failures at 10 years (LFR10) as first events were compared using competing risk analysis.
RESULTS


The median follow-up was 13.0 years. The first site of failure was local-only in 96 cases, locoregional in 16 cases, regional in 32 cases, and not specified in 2 cases; LFR10 was 4.8% (95% CI 4.1%-5.7%). LFR10 was 5.5% (95% CI 4.3%-7.2%), 4.9% (95% CI 3.7%-6.4%), and 2.8% (95% CI 1.9%-4.1%) in arms A, B, and C (B vs A: hazard ratio [HR] 0.91, P = .62; C vs A: HR 0.72, P = .12). For estrogen receptor-positive patients, LFR10 was 3.7% (95% CI 2.8%-4.8%) and for estrogen receptor-negative patients, it was 6.1% (95% CI 5.0%-7.4%; HR 0.61, P = .004). Local treatment included L+RT (n = 1044 [38%]), M+RT (n = 1025 [37%]), and M (n = 694 [25%]). LFR10 was 6.% (95% CI 5.0%-7.8%), 3.0% (95% CI 2.1%-4.3%), and 5.5% (95% CI 4.0%-7.4%) for L+RT, M+RT, and M, respectively (M+RT vs L+RT: HR 0.43, P < .001; M vs L+RT: HR 0.88, P = .57). For 1 to 3 positive lymph nodes, LFR10 was 6.5% (95% CI 4.8%-8.9%), 4.1% (95% CI 2.4%-7.0%), and 4.3% (95% CI 2.9%-6.5%) in L+RT, M+RT, and M, respectively (M vs L+RT: HR 0.68, P = .14; M vs M+RT: HR 1.2, P = .6).
CONCLUSION


Low 10-year LFRs were seen regardless of trastuzumab use. Differences in local therapy in patients with 1 to 3 positive lymph nodes did not appear to improve local control. Local therapy studies for HER2+ and other tumor characteristics are important as the role of local therapies continues to evolve.",2020,"(M vs L+RT: HR 0.68, P = .14;","['2763 patients with HER2-positive (HER2+) breast cancer', 'patients with 1 to 3 positive lymph nodes']","['L+RT', 'adjuvant trastuzumab', 'trastuzumab', 'adjuvant doxorubicin (A), cyclophosphamide (C), paclitaxel (T) and trastuzumab (H) (arm A, AC→T [n\xa0=\xa0922]; arm B, AC→T→H [n\xa0=\xa0988]; arm C, AC→T+H→H', 'M+RT', 'Radiotherapy']","['LFR10', 'Locoregional failures', 'locoregional failure rates', 'local control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",2763.0,0.165357,"(M vs L+RT: HR 0.68, P = .14;","[{'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Vargas', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Thorpe', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Tenner', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Davidson', 'Affiliation': 'Division of Medical Oncology, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'The Angeles Clinic and Research Institute, Santa Monica, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'E Shelley', 'Initials': 'ES', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michele Y', 'Initials': 'MY', 'LastName': 'Halyard', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Pockaj', 'Affiliation': 'Department of Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Department of Hematology & Oncology, Mayo Clinic, Jacksonville, Florida.'}]",Cancer,['10.1002/cncr.33154']
2431,32931045,Kitchen Hygiene in the Spotlight: How Cooking Shows Influence Viewers' Hygiene Practices.,"Poor hygiene when handling food is a major cause of foodborne illness. To investigate whether hygiene practices visible in television cooking shows influence viewers' kitchen hygiene, a study on the adoption of demonstrated hygiene behavior was conducted under controlled, experimental conditions. In a study ostensibly on cooking by following recipes participants (n = 65) were randomly assigned to one of three conditions, in which they watched a cooking video that differed only with regard to the hygiene behavior of the chef. In condition 1, the chef engaged in poor hygiene practices while preparing the dish, in condition 2 the chef's hygiene behavior was exemplary and in condition 3, the chef's hygiene behavior was not visible (control condition). After watching the video, participants were instructed to cook the recipe individually in the fully equipped laboratory kitchen. Cooking sessions were videotaped and experimenters blind to condition coded hygiene lapses committed by participants. The level of kitchen hygiene displayed in the cooking video significantly affected hygiene practices of participants cooking the recipe. Participants who had watched the cooking video with correct hygiene practices committed significantly fewer hygiene lapses than those who had watched the video with poor hygiene practices. From a risk communication perspective, TV cooking shows are well placed to convey knowledge of essential hygiene practices during food preparation to a broad audience. To facilitate behavioral change toward safer food-handling practices among viewers, visibly performing correct hygiene practices in cooking shows is a promising strategy.",2020,Participants who had watched the cooking video with correct hygiene practices committed significantly fewer hygiene lapses than those who had watched the video with poor hygiene practices.,"['Kitchen Hygiene in the Spotlight', 'recipes participants (n = 65', 'Participants who had watched the cooking video with correct hygiene practices']",[],['hygiene lapses'],"[{'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",[],"[{'cui': 'C0020405', 'cui_str': 'Hygiene'}]",65.0,0.0290401,Participants who had watched the cooking video with correct hygiene practices committed significantly fewer hygiene lapses than those who had watched the video with poor hygiene practices.,"[{'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'Department Risk Communication, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lohmann', 'Affiliation': 'Department Risk Communication, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Geppert', 'Affiliation': 'Household and Appliance Technology Section, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Stamminger', 'Affiliation': 'Household and Appliance Technology Section, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Epp', 'Affiliation': 'Department Risk Communication, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}, {'ForeName': 'Gaby-Fleur', 'Initials': 'GF', 'LastName': 'Böl', 'Affiliation': 'Department Risk Communication, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13584']
2432,32931136,COVID-19 clinical trials: ethical and scientific consequences of the RECOVERY trial results.,"The COVID-19 pandemic has spurred tremendous activity in clinical drug investigations worldwide. One large trial that may influence other trials is the RECOVERY trial, an open-label, adaptive, multi-arm, randomized clinical trial (RCT) assessing experimental medicines versus standard of care (SOC) in COVID-19 hospitalized patients, and with mortality as principal endpoint. Preliminary RECOVERY trial results have shown that dexamethasone reduced death rate in certain patients' subgroups (positive results), whereas both hydroxychloroquine and lopinavir/ritonavir produced no benefit (negative results) versus SOC.",2020,"Preliminary RECOVERY trial results have shown that dexamethasone reduced death rate in certain patients' subgroups (positive results), whereas both hydroxychloroquine and lopinavir/ritonavir produced no benefit (negative results) versus SOC.",[],"['dexamethasone', 'hydroxychloroquine and lopinavir/ritonavir']",['death rate'],[],"[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.227247,"Preliminary RECOVERY trial results have shown that dexamethasone reduced death rate in certain patients' subgroups (positive results), whereas both hydroxychloroquine and lopinavir/ritonavir produced no benefit (negative results) versus SOC.","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Dal-Ré', 'Affiliation': 'Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Centre of Research in Epidemiology and Statistics Sorbonne Paris Cité, Institute National de la Santé et de la Recherche Médicale, Joint Research Unit 1153, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Basic & clinical pharmacology & toxicology,['10.1111/bcpt.13489']
2433,32931137,What is the risk of permanent stoma beyond five years after low anterior resection for rectal cancer?,"AIM


Low anterior resection of the rectum for cancer(LAR) entails a risk of symptomatic anastomotic leakage as well as impaired anorectal function, both of which may eventually result in the need for a permanent stoma (PS). The aim was to investigate the incidence of and risk factors for PS beyond 5 years following LAR.
METHODS


Patients undergoing LAR and included in a multicentre trial with randomization to defunctioning stoma or not were followed for a median of 15 years. The reasons for a PS up to 5 years (PS≤5 years) and beyond 5 years (PS>5 years) were identified and compared. Risk factors for PS were analyzed.
RESULTS


Of all patients, 25% (57/232) had a PS. PS≤5years occurred in 19% (44/232) at a median of 12.5 months, and PS>5years in 6% (13/232) at a median of 118 months following LAR. The main reason for PS≤5 years was impaired anorectal function in 55% (24/44) and the main reason for PS>5 years was pelvic sepsis related to the colorectal anastomosis in 46% (6/13). The major risk factor for PS was symptomatic anastomotic leakage, which occurred in 56% (32/57) of patients with PS and 10% (17/175) of patients without PS (P<0.001).
CONCLUSION


One fourth of the patients who ended up with a permanent stoma had it fashioned beyond 5 years at a median of 10 years following low anterior resection. Symptomatic anastomotic leakage was the major risk factor for permanent stoma, and impaired anorectal function was the main overall reason for a permanent stoma.",2020,"PS≤5years occurred in 19% (44/232) at a median of 12.5 months, and PS>5years in 6% (13/232) at a median of 118 months following LAR.",['Patients undergoing LAR and included in a multicentre trial with randomization to defunctioning stoma or not were followed for a median of 15 years'],[],"['anorectal function', 'symptomatic anastomotic leakage', 'Symptomatic anastomotic leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}]",,0.0786998,"PS≤5years occurred in 19% (44/232) at a median of 12.5 months, and PS>5years in 6% (13/232) at a median of 118 months following LAR.","[{'ForeName': 'Soran', 'Initials': 'S', 'LastName': 'Gadan', 'Affiliation': 'Department of Surgery, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Floodeen', 'Affiliation': 'Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lindgren', 'Affiliation': 'Department of Surgery, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rutegård', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Matthiessen', 'Affiliation': 'Department of Surgery, Örebro University Hospital, Örebro, Sweden.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15364']
2434,32924550,Topical  Costus  sp. Preparation as Palliative Care for Chemotherapy-Induced Peripheral Neuropathy of Patients: A Randomized Placebo-Controlled Pilot Trial.,"Objectives:  Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of various anticancer regimens with different sensory-motor abnormalities in patients. The aim of this study was to examine the feasibility of using  Costus  sp. oil as a palliative treatment in such patients.  Design:  This was a pilot randomized placebo-controlled double-blind clinical study.  Settings/Location:  Imam Hossein Hospital, Tehran, Iran.  Subjects:  Patients 18-80 years of age undergoing chemotherapy treatment recently or during the last 6 months were enrolled after meeting the inclusion criteria.  Interventions:  The intervention group used  Costus  sp. as a topical ointment and the placebo group used topical paraffin for 4 weeks.  Outcome measures:  Feasibility of recruitment, including treatment acceptability (evaluated as number of patients leaving the study early), and compliance (defined as consumption of a minimum 80% of the ointment) with the intervention were assessed. Neuropathic pain change was defined as the secondary outcome, too.  Results:  Totally, 50 out of 73 participants were identified eligible and were randomly divided into intervention or placebo groups. There was no significant difference between groups in terms of sociodemographic data. At the end of the study, 24% (confidence interval [95% CI]: 9-45) (intervention group) and 12% (95% CI: 2-31) (placebo group) of patients revealed treatment unacceptability. Meanwhile, 12% (95% CI: 2-31) in the intervention group and 28% (95% CI: 12-49) in the placebo group did not show the compliance. Moreover, according to patients' records, pain reduction was higher in the intervention group compared to the placebo group ( p  = 0.001).  Conclusions:  This preliminary study showed that topical use of  Costus  sp. was feasible and acceptable in patients suffering from CIPN.",2020,"Moreover, according to patients' records, pain reduction was higher in the intervention group compared to the placebo group ( p  = 0.001).  ","['Patients', 'patients suffering from CIPN', 'Totally, 50 out of 73 participants were identified eligible', 'Subjects:  Patients 18-80 years of age undergoing chemotherapy treatment recently or during the last 6 months were enrolled after meeting the inclusion criteria', 'patients']","['topical paraffin', 'Chemotherapy-induced peripheral neuropathy (CIPN', 'placebo', 'intervention group used  Costus  sp', 'Placebo']","['Neuropathic pain change', 'sociodemographic data', 'pain reduction', 'Outcome measures:  Feasibility of recruitment, including treatment acceptability (evaluated as number of patients leaving the study early), and compliance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0110805', 'cui_str': 'Costus'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",73.0,0.357406,"Moreover, according to patients' records, pain reduction was higher in the intervention group compared to the placebo group ( p  = 0.001).  ","[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Heydarirad', 'Affiliation': 'Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Cramer', 'Affiliation': 'Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Choopani', 'Affiliation': 'Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Gharehgozlou', 'Affiliation': 'Cancer Research Center, Shohada Tajrish Hospital, Department of Radiation Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hamdollah', 'Initials': 'SH', 'LastName': 'Mosavat', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ameri', 'Affiliation': 'Department of Radiation Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Pasalar', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0012']
2435,32924652,The effect of time of day and chronotype on the relationships between mood state and performance in a Wingate test.,"The purpose of this study was to investigate the effects of time-of-day and morning vs. evening chronotype on the relationships between mood state and performance of extreme intensity cycling exercise. A quasi-experimental between-groups design was used to test the hypothesis that there would be an effect of time-of-day on mood state and physical performance, that mood state and physical performance would be interrelated, and that the relationships would be influenced by participants' morning  vs . evening chronotype. From 74 university students who volunteered, 7 were identified as morning types (M-types) and 7 as evening types (E-types). They completed the Profile of Mood States (POMS) questionnaire and performed a 30 s Wingate test on three different days, once at 08h00, once at 14h00, and once at 20h00. The main performance measure, work done in the Wingate test, increased across the day (16.4 ± 4.8 kJ < 17.0 ± 5.0 kJ < 17.6 ± 5.2 kJ;  p  < .01). For the M-types, individual changes in performance from the morning to the afternoon were correlated with individual changes in the POMS score for vigor ( r  = 0.81;  p  = .03) and changes in performance from the afternoon to the evening were correlated with individual changes in fatigue ( r  = - 0.85,  p  = .02). For the E-types, the opposite was true, as morning-to-afternoon changes in performance were correlated with individual changes in fatigue ( r  = - 0.70,  p  = .08) and afternoon-to-evening changes in performance were correlated with individual changes in vigor ( r  = 0.78,  p  = .04). Results demonstrate a time-of-day effect on morning  vs . evening chronotype-dependent relationships between mood state and cycling performance.",2020,"The main performance measure, work done in the Wingate test, increased across the day (16.4 ± 4.8 kJ < 17.0 ± 5.0 kJ < 17.6 ± ","['74 university students who volunteered, 7 were identified as morning types (M-types) and 7 as evening types (E-types']",[],"['POMS score for vigor', 'Profile of Mood States (POMS) questionnaire']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0587117', 'cui_str': 'Evening'}]",[],"[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0424637,"The main performance measure, work done in the Wingate test, increased across the day (16.4 ± 4.8 kJ < 17.0 ± 5.0 kJ < 17.6 ± ","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hill', 'Affiliation': 'Department of Kinesiology, Health Promotion, and Recreation, University of North Texas , Denton, Texas, USA.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'Activité Physique, Sport, et Santé, UR18JS01, Observatoire National du Sport , Tunis, Tunisia.'}]",Chronobiology international,['10.1080/07420528.2020.1786394']
2436,32924674,How hearing conservation training format impacts personal attenuation ratings in U.S. Marine Corps Training Recruits.,"OBJECTIVE


The purpose of this fit-testing study in the field was to systematically compare three Hearing Protection Device (HPD) fit-training methods and determine whether they differ in the acquisition of HPD fitting skill and resulting amount of earplug attenuation.
DESIGN


Subjects were randomly assigned to receive HPD fit-training using one of three training methods:  current ,  experiential HPD  (eHPD), and  integrated . Personal Attenuation Ratings (PARs) were acquired via HPD fit-testing and used to verify attenuations pre- and post-training.
STUDY SAMPLE


US Marine training recruits ( n  = 341) identified via HPD fit-testing for remedial HPD fit-training and assigned to three cohorts.
RESULTS


The post-training HPD fit-test passing rate differed by training method, with pass rates ranging from 50% (current) to nearly 92% (eHPD). The difference between group delta PAR values were significantly higher (>9 dB) in both the eHPD and integrated methods compared to the current method.
CONCLUSION


The HPD fit-training methods that teach ""what right feels like"" (eHPD and integrated) provided a greater number of trainees with the skill to achieve noise attenuation values required for impulse noise exposures encountered during basic training. The attenuation achieved by those methods was significantly greater than the current training method.",2020,"The difference between group delta PAR values were significantly higher (>9 dB) in both the eHPD and integrated methods compared to the current method.
","['SAMPLE\n\n\nUS Marine training recruits ( n \u2009=\u2009341) identified via HPD fit-testing for remedial HPD fit-training and assigned to three cohorts', 'Subjects']","['HPD fit-training using one of three training methods:  current ,  experiential HPD  (eHPD), and  integrated ']","['delta PAR values', 'Personal Attenuation Ratings (PARs']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0223195,"The difference between group delta PAR values were significantly higher (>9 dB) in both the eHPD and integrated methods compared to the current method.
","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Federman', 'Affiliation': 'Naval Submarine Medical Research Laboratory, Groton, CT, USA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Karch', 'Affiliation': 'Naval Submarine Medical Research Laboratory, Groton, CT, USA.'}, {'ForeName': 'Christon', 'Initials': 'C', 'LastName': 'Duhon', 'Affiliation': 'Naval Hospital Beaufort, BHC, MCRD, Parris Island, SC, USA.'}]",International journal of audiology,['10.1080/14992027.2020.1811407']
2437,32924685,Does central sensitization affect hyperalgesia after staged bilateral total knee arthroplasty? A randomized controlled trial.,"OBJECTIVE


Osteoarthritis (OA) patients who undergo staged bilateral total knee arthroplasty (TKA) feel postoperative hyperalgesia in the second operated knee compared with the first knee. Ketamine is an important drug for central temporal summation and inhibition of secondary mechanical hyperalgesia. This study investigated whether central sensitization has a significant effect on hyperalgesia after consecutive operations.
METHODS


Seventy-one of 80 OA patients were randomly allocated to the ketamine or saline group. A bolus of ketamine (group K) or saline (group C) (0.5 mg/kg) was injected before induction and at an infusion rate of 3 µg/kg/minute during surgery. A visual analog scale (VAS) was used to assess resting and moving pain and opioid consumption on postoperative days 1, 2, and 3.
RESULTS


The difference in the VAS score between stages 1 and 2 (D V2-V1 ) was higher in the ketamine compared with the saline group. D V2-V1  for movement between the two groups was not inferior for all periods. Ketamine did not show a large analgesic effect on second-operated knee hyperalgesia in staged bilateral TKAs.
CONCLUSIONS


We could not confirm that hyperalgesia was only related to central sensitization with low-dose ketamine. Other factors might be also associated with the hyperexcitability of nociceptive stimuli.Clinical Research Information Service (CRIS) trial registry no: KCT0001481.",2020,"Ketamine did not show a large analgesic effect on second-operated knee hyperalgesia in staged bilateral TKAs.
","['Seventy-one of 80 OA patients', 'Osteoarthritis (OA) patients who undergo']","['ketamine or saline', 'staged bilateral total knee arthroplasty (TKA', 'Ketamine', 'ketamine', 'saline']","['visual analog scale (VAS', 'hyperalgesia', 'VAS score']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.212176,"Ketamine did not show a large analgesic effect on second-operated knee hyperalgesia in staged bilateral TKAs.
","[{'ForeName': 'Hyun Jung', 'Initials': 'HJ', 'LastName': 'Koh', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': ""Department of Orthopedics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Eun Sung', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Hwang', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Lim', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hue Jung', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",The Journal of international medical research,['10.1177/0300060520938934']
2438,32924749,psychological intervention with parents improves treatment results and reduces punishment in enuretic children: a randamized clinical trial.,"PURPOSE


This study aims to evaluate the impact of psychological intervention with parents of enuretic children on treatment outcome.
MATERIAL AND METHODS


Sixty-six enuretic children were randomized into two groups. All children received urotherapy orientation and psychological counseling. Psychological intervention was performed with parents in Experimental Group (EG) and not in Control Group (CG). All parents answered a questionnaire to evaluate violence against their children (Parent-Child Conflict Tactics Scale - CTSPC), and the Tolerance Scale. The Child Behavior Checklist (CBCL) was applied to evaluate behavior problems. Children responded to the Impact Scale and the Children and Youth Self-Concept Scale - CYSCS. Treatment results were accessed with a 14 days wet night diary.
RESULTS


Mean age and gender were similar in both groups. CTSPC showed less violence after the treatment in EG (p=0.007). The Tolerance Scale showed that parents of enuretic children were intolerant and that, after treatment, intolerance had a greater decrease in EG (p<0.001). The Impact scale showed that children suffer some impact from enuresis, and that in those in EG this impact was smaller after treatment (p=0.008). No differences were seen in CBCL and CYSCS after intervention. After treatment, the percentage of dry nights had a greater improvement in EG (52[30-91]) than in CG (10[3-22.5]) p<0.001. Children in EG had 6.75 times greater chance to have a complete response to treatment.
CONCLUSION


Psychological intervention with parents of enuretic children during their treatment improved the percentage of dry nights and the impact of enuresis while their parents started coping better with the problem and became more tolerant, reducing punishment towards their children.
CLINICAL TRIAL REGISTRATION


ISRCTN registry, ISRCTN46655645, (https://doi.org/10.1186/ISRCTN46655645).",2020,"After treatment, the percentage of dry nights had a greater improvement in EG (52[30-91]) than in CG (10[3-22.5])","['enuretic children', 'Sixty-six enuretic children']","['psychological intervention', 'urotherapy orientation and psychological counseling', 'CTSPC', 'Psychological intervention']","['Tolerance Scale', 'violence against their children (Parent-Child Conflict Tactics Scale - CTSPC), and the Tolerance Scale', 'percentage of dry nights', 'violence', 'Child Behavior Checklist (CBCL', 'CBCL and CYSCS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0474178', 'cui_str': 'Psychological counseling'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0030540', 'cui_str': 'Parent-child problem'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",66.0,0.0234887,"After treatment, the percentage of dry nights had a greater improvement in EG (52[30-91]) than in CG (10[3-22.5])","[{'ForeName': 'Cacilda Andrade', 'Initials': 'CA', 'LastName': 'Sá', 'Affiliation': 'Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Stefani A', 'Initials': 'SA', 'LastName': 'Martins de Souza', 'Affiliation': 'Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Maria Cecilia Barbosa Vieira Almeida', 'Initials': 'MCBVA', 'LastName': 'Villela', 'Affiliation': 'Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Vitor de Moraes', 'Initials': 'VM', 'LastName': 'Souzaa', 'Affiliation': 'Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Márcia Helena de Fávero', 'Initials': 'MHF', 'LastName': 'de Souza', 'Affiliation': 'Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'André Avarese', 'Initials': 'AA', 'LastName': 'de Figueiredo', 'Affiliation': 'Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'de Bessa', 'Affiliation': 'State University of Feira de Santana, Feira de Santana, Bahia, Brazil.'}, {'ForeName': 'José Murillo B', 'Initials': 'JMB', 'LastName': 'Netto', 'Affiliation': 'Federal University of Juiz de Fora, Juiz de Fora, Minas Gerais, Brazil.'}]",The Journal of urology,['10.1097/JU.0000000000001351']
2439,32924787,Evaluation of Peroperative and Oncological Results in Laparoscopic Surgery of Gastric Cancer in Elderly Patients: Single-Center Study.,"Introduction:  Laparoscopic treatment of gastric cancer in elderly patients is still controversial. The aim of this retrospective study is to evaluate the safety and feasibility of laparoscopic gastrectomy in elderly gastric cancer patients based on the long- and short-term results of laparoscopic surgery.  Materials and Methods:  The data of 163 patients who underwent laparoscopic gastrectomy for gastric cancer. Patients were categorized into two groups by age based on World Health Organization (WHO) criteria: elderly (≥65 years, 80 cases) and nonelderly (<65 years, 83 cases). Patient characteristics and clinicopathological findings, surgical findings, short- and long-term results were compared between the two groups.  Results:  The patients in the study group were in the age range of 22-87 years and 80 (49%) patients were found out to be 65 years old or older. When all complications were categorized according to Clavien-Dindo (C-D) classification, >3 serious complication rates were similar between groups ( P  = .421). Although the length of hospital stay and the need for intensive care were higher in the elderly group, the difference was not significant ( P  = .066;  P  = .072). There was no significant difference between the two in terms of in-hospital mortality ( P  = .364). No statistically significant differences were found in the rates of overall survival (nonelderly group; 61.17 ± 3.34, 95% confidence interval [CI]: 54.61-67.74 versus elderly group; 56.48 ± 3.80, 95% CI: 49.03-63.93;  P  = .176) and disease-specific survival (nonelderly group; 64.24 ± 3.15, 95% CI: 58.06-70.40 versus elderly group; 61.93 ± 3.57, 95% CI: 54.93-68.93;  P  = .363) between the age groups.  Conclusion:  In conclusion, although laparoscopic gastrectomy is a feasible and safe method in elderly gastric cancer patients, further randomized prospective studies are needed.",2020,"Although the length of hospital stay and the need for intensive care were higher in the elderly group, the difference was not significant ( P  = .066;  P  = .072).","['elderly gastric cancer patients', 'elderly patients', 'Laparoscopic Surgery of Gastric Cancer in Elderly Patients', '163 patients who underwent', 'patients were found out to be 65 years old or older', 'patients in the study group were in the age range of 22-87 years and 80 (49', 'for gastric cancer', 'Patients were categorized into two groups by age based on World Health Organization (WHO) criteria: elderly (≥65 years, 80 cases) and nonelderly (<65 years, 83 cases']","['laparoscopic gastrectomy', 'Laparoscopic treatment', 'laparoscopic surgery']","['serious complication rates', 'length of hospital stay and the need for intensive care', 'hospital mortality', 'safety and feasibility', 'rates of overall survival', 'disease-specific survival']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",163.0,0.0607667,"Although the length of hospital stay and the need for intensive care were higher in the elderly group, the difference was not significant ( P  = .066;  P  = .072).","[{'ForeName': 'Afig', 'Initials': 'A', 'LastName': 'Gojayev', 'Affiliation': 'General Surgery Department, Surgical Oncology Clinic, Ankara University Medicine Faculty, Ankara, Turkey.'}, {'ForeName': 'Ogün', 'Initials': 'O', 'LastName': 'Erşen', 'Affiliation': 'General Surgery Department, Surgical Oncology Clinic, Ankara University Medicine Faculty, Ankara, Turkey.'}, {'ForeName': 'Ümit', 'Initials': 'Ü', 'LastName': 'Mercan', 'Affiliation': 'General Surgery Department, Surgical Oncology Clinic, Ankara University Medicine Faculty, Ankara, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Yüksel', 'Affiliation': 'General Surgery Department, Surgical Oncology Clinic, Ankara University Medicine Faculty, Ankara, Turkey.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Yalkın', 'Affiliation': 'Department of General Surgery, Bursa City Hospital, Bursa, Turkey.'}, {'ForeName': 'Sancar', 'Initials': 'S', 'LastName': 'Bayar', 'Affiliation': 'General Surgery Department, Surgical Oncology Clinic, Ankara University Medicine Faculty, Ankara, Turkey.'}, {'ForeName': 'Ali Ekrem', 'Initials': 'AE', 'LastName': 'Ünal', 'Affiliation': 'General Surgery Department, Surgical Oncology Clinic, Ankara University Medicine Faculty, Ankara, Turkey.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Demirci', 'Affiliation': 'General Surgery Department, Surgical Oncology Clinic, Ankara University Medicine Faculty, Ankara, Turkey.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2020.0472']
2440,32924913,A randomized clinical trial assessing a pragmatic intervention to improve supportive care for family caregivers of patients with lung cancer.,"OBJECTIVE


Family caregivers (FCs) of cancer patients often experience high distress. This randomized clinical trial assessed the feasibility and preliminary effects of an intervention to improve FC supportive care.
METHOD


A pragmatic and minimal intervention to improve FC supportive care was developed and pretested with FCs, oncology team, and family physicians to assess its relevance and acceptability. Then, FCs of lung cancer patients were randomized to the intervention or the control group. The intervention included (1) systematic FC distress screening and problem assessment in the first months after their relative cancer diagnosis, and every 2 months after; (2) privileged contact with an oncology nurse to address FC problems, provide emotional support and skills to play their caregiving role; (3) liaison with the family physician of FCs reporting high distress (distress thermometer score ≥4/10) to involve them in the provision of supportive care. Distress, the primary outcome, was measured every 3 months, for 9 months. Secondary outcomes included quality of life, caregiving preparedness, and perceived burden. At the end of their participation, a purposive sample of FC from the experimental group was individually interviewed to assess the intervention usefulness. Content analysis was performed.
RESULTS


A total of 109 FCs participated in the trial. FC distress decreased over time, but this reduction was observed in both groups. Similar results were found for secondary outcomes. However, FCs who received the intervention felt better prepared in caregiving than controls (p = 0.05). All 10 interviewed FCs valued the intervention, even though they clearly underused it. Knowing they could contact the oncology nurse served as a security net.
SIGNIFICANCE OF RESULTS


Although the intervention was not found effective, some of its aspects were positively perceived by FCs. As many of them experience high distress, an improved intervention should be developed to better support them.",2020,"However, FCs who received the intervention felt better prepared in caregiving than controls (p = 0.05).","['family caregivers of patients with lung cancer', 'Family caregivers (FCs) of cancer patients often experience high distress', 'lung cancer patients', 'A total of 109 FCs participated in the trial']","['systematic FC distress screening and problem assessment in the first months after their relative cancer diagnosis, and every 2 months after; (2) privileged contact with an oncology nurse to address FC problems, provide emotional support and skills to play their caregiving role; (3) liaison with the family physician of FCs reporting high distress (distress thermometer score ≥4/10) to involve them in the provision of supportive care', 'pragmatic intervention']","['FC distress', 'quality of life, caregiving preparedness, and perceived burden']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0557529', 'cui_str': 'Oncology nurse'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",109.0,0.0578252,"However, FCs who received the intervention felt better prepared in caregiving than controls (p = 0.05).","[{'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Aubin', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université Laval.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Vézina', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université Laval.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Verreault', 'Affiliation': 'VITAM-Centre de recherche en Santé Durable, Université Laval.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Simard', 'Affiliation': 'Research Centre of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ).'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Desbiens', 'Affiliation': 'VITAM-Centre de recherche en Santé Durable, Université Laval.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tremblay', 'Affiliation': 'Research Centre of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ).'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Dumont', 'Affiliation': 'VITAM-Centre de recherche en Santé Durable, Université Laval.'}, {'ForeName': 'Maman Joyce', 'Initials': 'MJ', 'LastName': 'Dogba', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université Laval.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gagnon', 'Affiliation': 'VITAM-Centre de recherche en Santé Durable, Université Laval.'}]",Palliative & supportive care,['10.1017/S1478951520000711']
2441,32924954,A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial.,"BACKGROUND


In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP's safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence.
OBJECTIVE


The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior.
METHODS


This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60).
RESULTS


Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing.
CONCLUSIONS


This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings.
TRIAL REGISTRATION


ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18640.",2020,"Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion.","['Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60', 'young minority men who have sex with men (MSM', 'young MSM']","['Mobile Gaming Intervention', 'cutting-edge, engaging, and entertaining app/gaming intervention', 'gaming intervention']","['PrEP adherence and HIV preventative behaviors', 'HIV risk behaviors']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0907411,"Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Whiteley', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Olsen', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Science, University of Mississippi Medical Center, Jackson, MS, United States.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Haubrick', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Craker', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Hershkowitz', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School, Brown University, Providence, RI, United States.'}]",JMIR research protocols,['10.2196/18640']
2442,32924981,"The effect of an eight-week shoulder rehabilitation intervention programme on pain and function, range of motion and muscle strength among teachers: A pilot study.","BACKGROUND


Teachers present with shoulder musculoskeletal disorders, which result in pain and poor shoulder function.
OBJECTIVE


To determine the effect of an eight-week shoulder rehabilitation intervention on pain and function, range of motion and muscle strength among teachers.
METHODS


Thirty teachers presenting with shoulder pain were recruited and divided into equal control and experimental groups. The intervention group participated in an eight-week rehabilitation programme. Pre- and post-intervention measurements included the scapular position test, range of motion, muscle strength measurements as well as a shoulder rating questionnaire.
RESULTS


There was a significant improvement in the experimental group's internal range of motion for the dominant (p= 0.006) and non-dominant arms (p= 0.003) post-intervention. Additionally, significant improvements were found in muscle strength in the experimental group in dominant and non-dominant flexion; abduction; external rotation (p< 0.001); dominant internal rotation (p< 0.001) and non-dominant internal rotation strength (p= 0.007). Post-intervention questionnaire data found a decrease in pain (p= 0.003); improved ability to perform daily activities (p= 0.006); improved overall score (p< 0.001) and satisfaction (p= 0.023) in the intervention group compared to the control group.
CONCLUSION


The implementation of a rehabilitation programme in schools should be considered to manage the prevalence of shoulder musculoskeletal disorders among teachers.",2020,"Post-intervention questionnaire data found a decrease in pain (p= 0.003); improved ability to perform daily activities (p= 0.006); improved overall score (p< 0.001) and satisfaction (p= 0.023) in the intervention group compared to the control group.
","['teachers', 'Teachers present with shoulder musculoskeletal disorders', 'Thirty teachers presenting with shoulder pain']","['eight-week shoulder rehabilitation intervention', 'eight-week shoulder rehabilitation intervention programme']","['internal range of motion', 'overall score', 'muscle strength', 'pain', 'scapular position test, range of motion, muscle strength measurements as well as a shoulder rating questionnaire', 'internal rotation', 'non-dominant internal rotation strength', 'satisfaction', 'ability to perform daily activities', 'pain and function, range of motion and muscle strength']","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",30.0,0.0159564,"Post-intervention questionnaire data found a decrease in pain (p= 0.003); improved ability to perform daily activities (p= 0.006); improved overall score (p< 0.001) and satisfaction (p= 0.023) in the intervention group compared to the control group.
","[{'ForeName': 'Zingisa Z', 'Initials': 'ZZ', 'LastName': 'Nyawose', 'Affiliation': ''}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Naidoo', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-200142']
2443,32925039,Metabolic and Neurocognitive Changes Following Lifestyle Modification: Examination of Biomarkers from the ENLIGHTEN Randomized Clinical Trial.,"BACKGROUND


Previous studies have demonstrated that aerobic exercise (AE) and the Dietary Approaches to Stop Hypertension (DASH) diet can improve neurocognition. However, the mechanisms by which lifestyle improves neurocognition have not been widely studied. We examined the associations between changes in metabolic, neurotrophic, and inflammatory biomarkers with executive functioning among participants from the Exercise and Nutritional Interventions for Neurocognitive Health Enhancement (ENLIGHTEN) trial.
OBJECTIVE


To examine the association between changes in metabolic function and neurocognition among older adults with cognitive impairment, but without dementia (CIND) participating in a comprehensive lifestyle intervention.
METHODS


ENLIGHTEN participants were randomized using a 2×2 factorial design to receive AE, DASH, both AE+DASH, or a health education control condition (HE) for six months. Metabolic biomarkers included insulin resistance (homeostatic model assessment [HOMA-IR]), leptin, and insulin-like growth factor (IGF-1); neurotrophic biomarkers included brain derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF); and inflammatory biomarkers included interleukin-6 (IL-6) and C-Reactive Protein (CRP).
RESULTS


Participants included 132 sedentary older adults (mean age = 65 [SD = 7]) with CIND. Results demonstrated that both AE (d = 0.48, p = 0.015) and DASH improved metabolic function (d = 0.37, p = 0.039), without comparable improvements in neurotrophic or inflammatory biomarkers. Greater improvements in metabolic function, including reduced HOMA-IR (B = -2.3 [-4.3, -0.2], p = 0.033) and increased IGF-1 (B = 3.4 [1.2, 5.7], p = 0.004), associated with increases in Executive Function.
CONCLUSION


Changes in neurocognition after lifestyle modification are associated with improved metabolic function.",2020,"Results demonstrated that both AE (d = 0.48, p = 0.015) and DASH improved metabolic function (d = 0.37, p = 0.039), without comparable improvements in neurotrophic or inflammatory biomarkers.","['Participants included 132 sedentary older adults (mean age\u200a=\u200a65', 'older adults with cognitive impairment, but without dementia (CIND) participating in a comprehensive lifestyle intervention', 'participants from the Exercise and Nutritional Interventions for Neurocognitive Health Enhancement (ENLIGHTEN) trial']","['aerobic exercise (AE', 'AE, DASH, both AE+DASH, or a health education control condition (HE']","['DASH improved metabolic function', 'Metabolic and Neurocognitive Changes', 'neurotrophic or inflammatory biomarkers', 'insulin resistance (homeostatic model assessment [HOMA-IR]), leptin, and insulin-like growth factor (IGF-1); neurotrophic biomarkers included brain derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF); and inflammatory biomarkers included interleukin-6 (IL-6) and C-Reactive Protein (CRP', 'metabolic function', 'Executive Function', 'metabolic function and neurocognition', 'IGF-1', 'reduced HOMA-IR']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",132.0,0.0789141,"Results demonstrated that both AE (d = 0.48, p = 0.015) and DASH improved metabolic function (d = 0.37, p = 0.039), without comparable improvements in neurotrophic or inflammatory biomarkers.","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Mabe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Murali Doraiswamy', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Welsh-Bohmer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Browndyke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Babyak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200374']
2444,32925045,White Matter Changes on Diffusion Tensor Imaging in the FINGER Randomized Controlled Trial.,"BACKGROUND


Early pathological changes in white matter microstructure can be studied using the diffusion tensor imaging (DTI). It is not only important to study these subtle pathological changes leading to cognitive decline, but also to ascertain and how an intervention would impact the white matter microstructure and cognition in persons at-risk of dementia.
OBJECTIVES


To study the impact of a multidomain lifestyle intervention on white matter and cognitive changes during the 2-year Finnish Geriatric Intervention Study to prevent Cognitive Impairment and Disability (FINGER), a randomized controlled trial in at-risk older individuals (age 60-77 years) from the general population.
METHODS


This exploratory study consisted of a subsample of 60 FINGER participants. Participants were randomized to either a multidomain intervention (diet, exercise, cognitive training, and vascular risk management, n = 34) or control group (general health advice, n = 26). All underwent baseline and 2-year brain DTI. Changes in fractional anisotropy (FA), diffusivity along domain (F1) and non-domain (F2) diffusion orientations, mean diffusivity (MD), axial diffusivity (AxD), radial diffusivity (RD), and their correlations with cognitive changes during the 2-year multidomain intervention were analyzed.
RESULTS


FA decreased, and cognition improved more in the intervention group compared to the control group (p <  0.05), with no significant intergroup differences for changes in F1, F2, MD, AxD, or RD. The cognitive changes were significantly positively related to FA change, and negatively related to RD change in the control group, but not in the intervention group.
CONCLUSION


The 2-year multidomain FINGER intervention may modulate white matter microstructural alterations.",2020,"RESULTS


FA decreased, and cognition improved more in the intervention group compared to the control group (p <  0.05), with no significant intergroup differences for changes in F1, F2, MD, AxD, or RD.","['at-risk older individuals (age 60-77 years) from the general population', 'subsample of 60 FINGER participants', 'white matter and cognitive changes during the 2-year Finnish Geriatric Intervention Study to prevent Cognitive Impairment and Disability (FINGER']","['multidomain intervention (diet, exercise, cognitive training, and vascular risk management, n\u200a=\u200a34) or control group (general health advice, n\u200a=\u200a26', 'multidomain FINGER intervention', 'multidomain lifestyle intervention']","['FA decreased, and cognition', 'F1, F2, MD, AxD, or RD', 'cognitive changes', 'fractional anisotropy (FA), diffusivity along domain (F1) and non-domain (F2) diffusion orientations, mean diffusivity (MD), axial diffusivity (AxD), radial diffusivity (RD), and their correlations with cognitive changes', 'RD change']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035649', 'cui_str': 'Risk management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332287', 'cui_str': 'With'}]",60.0,0.0249422,"RESULTS


FA decreased, and cognition improved more in the intervention group compared to the control group (p <  0.05), with no significant intergroup differences for changes in F1, F2, MD, AxD, or RD.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Stephen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Solomon', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tiia', 'Initials': 'T', 'LastName': 'Ngandu', 'Affiliation': 'Division of Clinical Geriatrics, Center for Alzheimer Research, NVS, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Esko', 'Initials': 'E', 'LastName': 'Levälahti', 'Affiliation': 'Public Health Promotion Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Juha O', 'Initials': 'JO', 'LastName': 'Rinne', 'Affiliation': 'Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kemppainen', 'Affiliation': 'Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Parkkola', 'Affiliation': 'Division of Clinical Neurosciences, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Antikainen', 'Affiliation': 'Center for Life Course Health Research/Geriatrics, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Strandberg', 'Affiliation': 'Center for Life Course Health Research/Geriatrics, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Kivipelto', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Hilkka', 'Initials': 'H', 'LastName': 'Soininen', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Yawu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200423']
2445,32925060,"Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study.","BACKGROUND


Apathy, a profound loss of motivation, initiation, and goal directed cognition, is a common comorbidity of Alzheimer's disease (AD). The presence of apathy is associated with rapid progression of AD, long-term impairment, disability, and higher mortality. Pharmacological treatments of apathy are limited.
OBJECTIVE


The primary objective was to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy in AD.
METHODS


A randomized, double-blind, parallel-arm, sham-controlled pilot study was conducted in subjects with AD and apathy (N = 20). Subjects were randomized to rTMS or sham treatment (5 days/week) for four weeks. Primary outcome, apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI), were assessed at baseline and four weeks. Follow-up visits were conducted at 8 and 12 weeks to test the durability of effects of intervention.
RESULTS


Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks. There was also significantly greater improvement in 3MS (6.9 (1.7 to 12.0); t (15)  = 2.85; p = 0.012), IADL (3.4 (1.0 to 5.9); χ21 = 7.72; p = 0.006), CGI-S (1.4 (0.5 to 2.3), t (16)  = 3.29; p = 0.005), and CGI-I (-2.56 (-3.5 to -1.6), t (17)  = -5.72; p < 0.001) for rTMS compared to the sham at 4 weeks. The effects of rTMS were durable at 12 weeks.
CONCLUSION


rTMS may be safely used in subjects with AD and may improve apathy, function, and some aspects of cognition.",2020,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks.","[""Alzheimer's Disease"", 'subjects with AD and apathy (N\u200a=\u200a20', 'Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females', 'subjects with AD']","['rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['3MS', 'IADL', 'apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI', 'CGI-S']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.540663,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks.","[{'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Eugenia M', 'Initials': 'EM', 'LastName': 'Boozer', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parkes', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Cassandra R', 'Initials': 'CR', 'LastName': 'Hunter', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Caceda', 'Affiliation': 'Department of Psychiatry, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Kalpana P', 'Initials': 'KP', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200640']
2446,32925066,Can Alzheimer's Disease Be Prevented? First Evidence from Spinal Stimulation Efficacy on Executive Functions.,"BACKGROUND


Recently, a growing body of evidence has shown that, from the early stage of impairment, Alzheimer's patients (AD) present difficulties on a variety of tasks mostly relying on executive functions. These strongly impact their daily life activities causing a severe loss of independency and autonomy.
OBJECTIVE


To evaluate the efficacy of transpinal direct current stimulation (tsDCS) combined with cognitive trainings for improving attentional and executive function abilities in a group of AD patients.
METHODS


In a randomized-double blind design, sixteen AD patients underwent different cognitive trainings combined with tsDCS. During the treatment, each subject received tsDCS (20 min, 2 mA) over the thoracic vertebrae (IX-X vertebrae) in two different conditions: 1) anodal, and 2) sham while performing three computerized tasks: alertness, selective attention, and executive functions. Each experimental condition was run in ten consecutive daily sessions over two weeks.
RESULTS


After anodal tsDCS, a greater improvement in executive functions compared to sham condition was found. More importantly, the follow-up testing revealed that these effects lasted over 1 month after the intervention and generalized to the different neuropsychological tests administered before, after the treatment and at one month after the end of the intervention. This generalization was present also in the attentional domain.
CONCLUSION


This evidence emphasizes, for the first time, that tsDCS combined with cognitive training results efficacious for AD patients. We hypothesize that enhancing activity into the spinal sensorimotor pathways through stimulation improved cognitive abilities which rely on premotor activity, such as attention and executive functions.",2020,"After anodal tsDCS, a greater improvement in executive functions compared to sham condition was found.","['AD patients', 'a group of AD patients', 'sixteen AD patients']","['transpinal direct current stimulation (tsDCS) combined with cognitive trainings', 'tsDCS combined with cognitive training', 'cognitive trainings combined with tsDCS', 'anodal, and 2) sham while performing three computerized tasks: alertness, selective attention, and executive functions']","['executive functions', 'Executive Functions', 'attentional and executive function abilities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",16.0,0.0954759,"After anodal tsDCS, a greater improvement in executive functions compared to sham condition was found.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pisano', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Satriano', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Perri', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Fadda', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Marangolo', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200695']
2447,32925119,Sensor-based technology for upper limb rehabilitation in subjects with multiple sclerosis: A randomized controlled trial.,"BACKGROUND


Sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper extremities function limitations. The sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows, and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database to quantitatively monitoring measures and therapy progress.
OBJECTIVE


This study aimed to investigate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limb functions of patients with MS.
METHODS


Thirty patients were enrolled in the study and randomly assigned to the experimental group and the control group. The training consisting of twelve sessions of upper limb training was compared with twelve sessions of upper limb sensory-motor training, without robotic support. Both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to conventional therapy. All patients were evaluated at the baseline (T0) and after 4 weeks of training (T1).
RESULTS


The within-subject analysis showed a statistically significant improvement in both groups, in the Modified Barthel Index and in the Rivermead Mobility Index scores and a significant improvement in Multiple Sclerosis Quality of Life-54 in the experimental. The analysis of effectiveness revealed that, compared with baseline (T0), the improvement percentage in all clinical scale scores was greater in the experimental group than the control group.
CONCLUSIONS


Proposed training provides an intensive and functional-oriented rehabilitation that objectively evaluates achieved progress through exercises. Therefore, it can represent a good complementary strategy for hand rehabilitation in MS patients.",2020,"The within-subject analysis showed a statistically significant improvement in both groups, in the Modified Barthel Index and in the Rivermead Mobility Index scores and a significant improvement in Multiple Sclerosis Quality of Life-54 in the experimental.","['MS patients', 'patients with MS.\nMETHODS\n\n\nThirty patients', 'people with Multiple Sclerosis (MS', 'subjects with multiple sclerosis']","['Sensor-based technology', 'upper limb training was compared with twelve sessions of upper limb sensory-motor training, without robotic support', 'sensor-based motor rehabilitation']","['Multiple Sclerosis Quality of Life-54', 'clinical scale scores', 'Rivermead Mobility Index scores']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0556501', 'cui_str': 'Upper limb training'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.0183361,"The within-subject analysis showed a statistically significant improvement in both groups, in the Modified Barthel Index and in the Rivermead Mobility Index scores and a significant improvement in Multiple Sclerosis Quality of Life-54 in the experimental.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Morone', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'De Angelis', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Casagrande Conti', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Galeoto', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Piazzale Aldo Moro 5, Rome 00185, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Grazia Grasso', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201033']
2448,32925123,Comparative study on the efficacy and safety of alteplase and urokinase in the treatment of acute cerebral infarction.,"BACKGROUND


Acute cerebral infarction (ACI) is a common cerebrovascular disease in clinical practice.
OBJECTIVE


The present study aims to investigate the efficacy and safety of alteplase and urokinase in treating ACI.
METHODS


A total of 96 patients with ACI, who were treated with alteplase and urokinase, were selected as the main subjects. Among these patients, 45 patients with ultra-early acute cerebral infarction, who received intravenous thrombolysis with RT-PA (alteplase), were included in the treatment group, while 51 patients with acute cerebral infarction, who were treated with urokinase in the same time period, were included in the control group.
RESULTS


The National Institute of Health Stroke Scale (NIHSS) scores were significantly lower in the treatment group and control group (P< 0.05) at two hours, seven days and 14 days after thrombolysis, when compared to those before thrombolysis. The bleeding rate was significantly lower in the control group, when compared to the treatment group (P< 0.05).
CONCLUSION


The intravenous thrombolysis with urokinase or alteplase in the ultra-early stage of acute cerebral infarction can reduce the neurological injury symptoms and effectively improve the prognosis of patients with stroke. Urokinase is lower in risk of bleeding, but better in safety, when compared to alteplase.",2020,"The bleeding rate was significantly lower in the control group, when compared to the treatment group (P< 0.05).
","['96 patients with ACI, who were treated with alteplase and urokinase, were selected as the main subjects', '45 patients with ultra-early acute cerebral infarction', '51 patients with acute cerebral infarction, who were treated with urokinase in the same time period, were included in the control group', 'acute cerebral infarction', 'patients with stroke']","['intravenous thrombolysis with RT-PA (alteplase', 'alteplase and urokinase', 'urokinase or alteplase']","['National Institute of Health Stroke Scale (NIHSS) scores', 'efficacy and safety', 'bleeding rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0042071', 'cui_str': 'Urokinase'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",96.0,0.0216264,"The bleeding rate was significantly lower in the control group, when compared to the treatment group (P< 0.05).
","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ""Department of Neurology, Hulun Buir People's Hospital, Hulun Buir, Inner Mongolia 021008, China.""}, {'ForeName': 'Hao-Ran', 'Initials': 'HR', 'LastName': 'Gao', 'Affiliation': ""Department of Neurology, Hulun Buir People's Hospital, Hulun Buir, Inner Mongolia 021008, China.""}, {'ForeName': 'Min-Lu', 'Initials': 'ML', 'LastName': 'Pan', 'Affiliation': ""Department of Neurology, Hulun Buir People's Hospital, Hulun Buir, Inner Mongolia 021008, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Rehabilitation Medicine, Hulun Buir People's Hospital, Hulun Buir, Inner Mongolia 021008, China.""}, {'ForeName': 'Hai-Bin', 'Initials': 'HB', 'LastName': 'Sun', 'Affiliation': ""Department of Rehabilitation Medicine, Hulun Buir People's Hospital, Hulun Buir, Inner Mongolia 021008, China.""}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-202382']
2449,32925145,Long-term employment status and quality of life after a cancer: A longitudinal prospective cohort study from diagnosis up to and including 5 years post diagnosis.,"BACKGROUND


Accumulating evidence suggests that cancer survivors are able to return to work. However, little is known about their work situation 5 years after diagnosis.
OBJECTIVE


To explore fluctuations in employment status and its association with quality of life 2, 3, and 5 years after cancer diagnosis of 65 cancer survivors employed at diagnosis.
METHODS


In association with a randomised controlled trial (RCT), questionnaires were administrated to eligible cancer survivors at diagnosis, 2, 3, and 5 years thereafter comprising of validated questionnaires related to work (i.e. Work Ability Index (WAI), cancer, and quality of life (QOL) (i.e. SF-36, VAS QOL). The RCT studied a hospital-based work support intervention in female breast and gynaecological cancer survivors who were treated with curative intent and had paid work at diagnosis. Descriptive statistics and longitudinal multi-level analysis were employed.
RESULTS


Sixty-five of the 102 eligible cancer survivors participated, who were primarily diagnosed with breast cancer (63%). Two and 5 years after cancer diagnosis respectively 63 (97%) and 48 (81%) participants were employed. Reasons for not being employed after 5 years included receiving unemployment benefits (7%), voluntary unemployment (3%), receiving disability benefits (3%), and early retirement (3%). Longitudinal multi-level analysis showed that employed cancer survivors reported in general statistically significant better quality of life outcomes at 5 years follow-up compared to those not being employed.
CONCLUSIONS


We found high employment rates and few fluctuations in employment status. The steepest decline in employment rate occurs within the first two years after diagnosis. Employed participants reported better quality of life outcomes. Survivorship care should therefore focus on the population at risk possibly within the first two years after diagnosis.",2020,"Longitudinal multi-level analysis showed that employed cancer survivors reported in general statistically significant better quality of life outcomes at 5 years follow-up compared to those not being employed.
","['after a cancer', '65 cancer survivors employed at diagnosis', 'Sixty-five of the 102 eligible cancer survivors participated, who were primarily diagnosed with breast cancer (63', 'female breast and gynaecological cancer survivors who were treated with curative intent and had paid work at diagnosis', 'cancer survivors']",[],"['quality of life outcomes', 'voluntary unemployment', 'quality of life', 'Work Ability Index (WAI), cancer, and quality of life (QOL) (i.e. SF-36, VAS QOL', 'receiving disability benefits']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0222603', 'cui_str': 'Female mammary gland structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",102.0,0.062273,"Longitudinal multi-level analysis showed that employed cancer survivors reported in general statistically significant better quality of life outcomes at 5 years follow-up compared to those not being employed.
","[{'ForeName': 'Sietske J', 'Initials': 'SJ', 'LastName': 'Tamminga', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Department: Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Lyanne P', 'Initials': 'LP', 'LastName': 'Jansen', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Department: Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Monique H W', 'Initials': 'MHW', 'LastName': 'Frings-Dresen', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Department: Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Angela G E M', 'Initials': 'AGEM', 'LastName': 'de Boer', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Department: Coronel Institute of Occupational Health, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}]","Work (Reading, Mass.)",['10.3233/WOR-203234']
2450,32922454,The effect of electronic monitoring combined with weekly feedback and reminders on adherence to inhaled corticosteroids in infants and younger children with asthma: a randomized controlled trial.,"Background


Adherence to asthma treatment among children is usually poor. We sought to explore whether electronic adherence monitoring combined with weekly feedback regarding adherence along with a reminder to use inhaled corticosteroids (ICS) would lead to improved compliance with ICS in infants and younger children with asthma.
Methods


96 recruited children (aged 6 months to 3 years) with mild or moderate persistent asthma who were on regular inhaled corticosteroids were randomly allocated to receive electronic monitoring combined with instant messaging software (IMS)-based weekly feedback regarding adherence along with a reminder to keep taking the ICS (intervention group) and to receive electronic monitoring only (control group).
Results


The mean device-monitored adherence was significantly higher in the intervention group (80%) than in the control group (45.9%), with a difference of 34.0% (95% confidence interval [CI], 26.8-41.3%;  P  < 0.001). No difference in the mean caregiver-reported adherence between the interventional group (89.7%) and the control group (92.7%) was observed ( P  = 0.452).
Conclusions


Electronic monitoring combined with IMS-based weekly feedback regarding adherence along with a reminder to keep taking the ICS significantly improved the treatment compliance of infants and younger children with asthma. Caregiver-reported adherence is an unreliable monitoring indicator. Trial registration  ClinicalTrials.gov, NCT03277664. Registered 11 September 2017-Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=NCT03277664.",2020,"No difference in the mean caregiver-reported adherence between the interventional group (89.7%) and the control group (92.7%) was observed ( P  = 0.452).
","['96 recruited children (aged 6\xa0months to 3\xa0years) with mild or moderate persistent asthma who were on regular inhaled corticosteroids', 'infants and younger children with asthma']","['electronic monitoring combined with instant messaging software (IMS)-based weekly feedback regarding adherence along with a reminder to keep taking the ICS (intervention group) and to receive electronic monitoring only (control group', 'inhaled corticosteroids', 'electronic monitoring combined with weekly feedback and reminders', 'corticosteroids (ICS']","['mean caregiver-reported adherence', 'mean device-monitored adherence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1960047', 'cui_str': 'Moderate persistent asthma'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0181904', 'cui_str': 'Monitor'}]",96.0,0.215177,"No difference in the mean caregiver-reported adherence between the interventional group (89.7%) and the control group (92.7%) was observed ( P  = 0.452).
","[{'ForeName': 'Jiande', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory Medicine, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, No. 1678 Dongfang Road, Pudong, Shanghai, 200127 China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Respiratory Medicine, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, No. 1678 Dongfang Road, Pudong, Shanghai, 200127 China.""}, {'ForeName': 'Liebin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Respiratory Medicine, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, No. 1678 Dongfang Road, Pudong, Shanghai, 200127 China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory Medicine, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, No. 1678 Dongfang Road, Pudong, Shanghai, 200127 China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': ""Department of Respiratory Medicine, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, No. 1678 Dongfang Road, Pudong, Shanghai, 200127 China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory Medicine, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, No. 1678 Dongfang Road, Pudong, Shanghai, 200127 China.""}]","Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology",['10.1186/s13223-020-00466-6']
2451,32922460,The effects of plyometric jump training on jump and sport-specific performances in prepubertal female swimmers.,"Background/objective


Dry land-training (e.g., plyometric jump training) can be a useful mean to improve swimming performance. This study examined the effects of an 8-week plyometric jump training (PJT) program on jump and sport-specific performances in prepubertal female swimmers.
Methods


Twenty-two girls were randomly assigned to either a plyometric jump training group (PJT G ; n = 12, age: 10.01 ± 0.57 years, maturity-offset = -1.50 ± 0.50, body mass = 36.39 ± 6.32 kg, body height = 146.90 ± 7.62 cm, body mass index = 16.50 ± 1.73 kg/m2) or an active control (CG; n = 10, age: 10.50 ± 0.28 years, maturity-offset = -1.34 ± 0.51, body mass = 38.41 ± 9.42 kg, body height = 143.60 ± 5.05 cm, body mass index = 18.48 ± 3.77 kg/m2). Pre- and post-training, tests were conducted for the assessment of muscle power (e.g., countermovement-jump [CMJ], standing-long-jump [SLJ]). Sport-specific-performances were tested using the timed 25 and 50-m front crawl with a diving-start, timed 25-m front crawl without push-off from the wall (25-m WP), and a timed 25-m kick without push-off from the wall (25-m KWP).
Results


Findings showed a significant main effect of time for the CMJ (d = 0.78), the SLJ (d = 0.91), 25-m front crawl test (d = 2.5), and the 25-m-KWP (d = 1.38) test. Significant group × time interactions were found for CMJ, SLJ, 25-m front crawl, 50-m front crawl, 25-m KWP, and 25-m WP test (d = 0.29-1.63) in favor of PJT G  (d = 1.34-3.50). No significant pre-post changes were found for CG (p > 0.05).
Conclusion


In sum, PJT is effective in improving muscle power and sport-specific performances in prepubertal swimmers. Therefore, PJT should be included from an early start into the regular training program of swimmers.",2021,"In sum, PJT is effective in improving muscle power and sport-specific performances in prepubertal swimmers.","['prepubertal female swimmers', '10.01\xa0±\xa00.57 years, maturity-offset\xa0=\xa0-1.50\xa0±\xa00.50, body mass\xa0=\xa036.39\xa0±\xa06.32\xa0kg, body height\xa0=\xa0146.90\xa0±\xa07.62\xa0cm, body mass index\xa0=\xa016.50\xa0±\xa01.73\xa0kg/m2) or an active control (CG; n\xa0=\xa010, age: 10.50\xa0±\xa00.28 years, maturity-offset\xa0=\xa0-1.34\xa0±\xa00.51, body mass\xa0=\xa038.41\xa0±\xa09.42\xa0kg, body height\xa0=\xa0143.60\xa0±\xa05.05\xa0cm, body mass index\xa0=\xa018.48\xa0±', 'prepubertal swimmers', 'group (PJT G ; n\xa0=\xa012, age', 'Methods\n\n\nTwenty-two girls']","['plyometric jump training (PJT) program', 'Pre- and post-training', '/objective\n\n\nDry land-training (e.g., plyometric jump training', 'PJT', 'plyometric jump training']","['CMJ, SLJ, 25-m front crawl, 50-m front crawl, 25-m KWP, and 25-m WP test ', 'muscle power and sport-specific performances']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517445', 'cui_str': '0.28'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0235042', 'cui_str': 'Does crawl'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",22.0,0.0253145,"In sum, PJT is effective in improving muscle power and sport-specific performances in prepubertal swimmers.","[{'ForeName': 'Senda', 'Initials': 'S', 'LastName': 'Sammoud', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"" Higher Institute of Sports and Physical Education of Ksar Said, University de ""La Manouba"", Manouba, Tunisia.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"" Higher Institute of Sports and Physical Education of Ksar Said, University de ""La Manouba"", Manouba, Tunisia.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"" Higher Institute of Sports and Physical Education of Ksar Said, University de ""La Manouba"", Manouba, Tunisia.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Hachana', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"" Higher Institute of Sports and Physical Education of Ksar Said, University de ""La Manouba"", Manouba, Tunisia.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Am Neuen Palais 10, 14469, Potsdam, Germany.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Am Neuen Palais 10, 14469, Potsdam, Germany.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.07.003']
2452,32922461,The effects of dry-land strength training on competitive sprinter swimmers.,"Background/objective


This study aimed to examine the effects of eight weeks of dry-land strength combined with swimming training on the development of upper and lower body strength, jumping ability, and swimming performance in competitive sprinter swimmers.
Methods


Twenty (14 men and 6 women) university swimmers of national-level (age: 20.55 ± 1.76 years, body mass: 68.86 ± 7.69 kg, height: 1.77 ± 0.06 m, 100 m front crawl: 71.08 ± 6.71s, 50 m front crawl: 31.70 ± 2.45s) were randomly divided into two groups: experimental group (EG: 11) and control group (CG: 9). In addition to the usual in-water training (3-4 sessions per week of ∼80 min), the EG performed 8 weeks (one session per week) of strength-training (ST). The ST included bench press, full squat, countermovement jumping, countermovement jumping with free-arm movement, and the medical ball throwing. Stroke length, stroke frequency, stroke index, and swimming velocity were recorded during 50 and 100 m front crawl time-trials. Strength and swimming performance were evaluated before and after 8 weeks of training.
Results


The results showed a significant improvement in sprint performance (50 m: p < 0.01, d = 0.47; 100 m: p < 0.05, d = 0.42), stroke frequency (50 m: p < 0.01, d = 0.90) and stroke index (100 m: p < 0.01, d = 0.29) in the EG. Despite both groups' increased strength performance, increases in bench press were higher in the EG (p < 0.001, d = 0.75) than CG (p = 0.05, d = 0.34).
Conclusions


Complementing in-water training with strength training seems to be relevant to improve upper body strength and to optimize 50 m and 100 m swimming performance, adapting technical patterns used during all-out swimming.",2021,"The results showed a significant improvement in sprint performance (50 m: p < 0.01, d = 0.47; 100 m: p < 0.05, d = 0.42), stroke frequency","['competitive sprinter swimmers', 'Methods\n\n\nTwenty (14 men and 6 women) university swimmers of national-level (age: 20.55\xa0±\xa01.76 years, body mass: 68.86\xa0±\xa07.69\xa0kg, height: 1.77\xa0±\xa00.06\xa0m, 100\xa0m front crawl: 71.08\xa0±\xa06.71s, 50\xa0m front crawl: 31.70\xa0±\xa02.45s']","['dry-land strength training', 'full squat, countermovement jumping, countermovement jumping with free-arm movement, and the medical ball throwing', 'strength-training (ST', 'dry-land strength combined with swimming training']","['development of upper and lower body strength, jumping ability, and swimming performance', 'Stroke length, stroke frequency, stroke index, and swimming velocity', 'stroke frequency', 'sprint performance', 'stroke index', 'Strength and swimming performance', 'strength performance']","[{'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456712', 'cui_str': 'Stroke index'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0158862,"The results showed a significant improvement in sprint performance (50 m: p < 0.01, d = 0.47; 100 m: p < 0.05, d = 0.42), stroke frequency","[{'ForeName': 'Tiago J', 'Initials': 'TJ', 'LastName': 'Lopes', 'Affiliation': 'University of Beira Interior, Department of Sport Sciences, Covilhã, Portugal.'}, {'ForeName': 'Henrique P', 'Initials': 'HP', 'LastName': 'Neiva', 'Affiliation': 'University of Beira Interior, Department of Sport Sciences, Covilhã, Portugal.'}, {'ForeName': 'Carlota A', 'Initials': 'CA', 'LastName': 'Gonçalves', 'Affiliation': 'University of Beira Interior, Department of Sport Sciences, Covilhã, Portugal.'}, {'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Nunes', 'Affiliation': 'University of Beira Interior, Department of Sport Sciences, Covilhã, Portugal.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'University of Beira Interior, Department of Sport Sciences, Covilhã, Portugal.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.06.005']
2453,32922462,Game format alters the physiological and activity demands encountered during small-sided football games in recreational players.,"Background


Conditioning in the form of football small-sided games (SSG) is being increasingly utilized as a health-promoting and performance-enhancing activity.
Objective


The aim of this study was to quantify and compare the physiological responses and activity demands encountered during 3-a-side, 4-a-side, and 5-a-side football SSG in recreational players.
Method


Heart rate, blood lactate (BLa), rating of perceived exertion (RPE) and activity demands were measured across 2 × 20-min football sessions played on a 40 × 20-m pitch in 12 recreationally active college students. Data were collected over a period of two weeks using a repeated-measures crossover design.
Results


Mean heart rate was higher (moderate) during 5-a-side than 4-a-side (p = 0.02) and 3-a-side SSG (p < 0.001). BLa tended to be higher (small) in 3-a-side compared to 4-a-side (p = 0.12) and 5-a-side SSG (p = 0.46). The total distance covered was lower (large) during 5-a-side than 4-a-side SSG (p = 0.02), while the total number of accelerations (p = 0.01) and decelerations (p = 0.02) were higher (large) during 5-a-side than 4-a-side SSG.
Conclusion


These data suggest: 1) 5-a-side SSG require a greater intermittent workload and exacerbated HR responses; 2) 4-a-side SSG require more sustained activity (distance); and 3) 3-a-side SSG result in higher BLa compared to other SSG formats. The observed intermittent workload and exacerbated HR response in 5-a-side SSG were likely due to greater turnover rates with more frequent interceptions. Sustained activity in 4-a-side SSG might be underpinned by format-specific structures permitting optimal team work, while isolated guarding of players in 3-a-side SSG may have exacerbated BLa responses.",2021,"The total distance covered was lower (large) during 5-a-side than 4-a-side SSG (p = 0.02), while the total number of accelerations (p = 0.01) and decelerations (p = 0.02) were higher (large) during 5-a-side than 4-a-side SSG.
","['recreational players', '12 recreationally active college students']",[],"['observed intermittent workload and exacerbated HR response', 'total distance', 'total number of accelerations', 'Method\n\n\nHeart rate, blood lactate (BLa), rating of perceived exertion (RPE) and activity demands', 'decelerations', 'Mean heart rate', 'BLa']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0271609,"The total distance covered was lower (large) during 5-a-side than 4-a-side SSG (p = 0.02), while the total number of accelerations (p = 0.01) and decelerations (p = 0.02) were higher (large) during 5-a-side than 4-a-side SSG.
","[{'ForeName': 'Emilija', 'Initials': 'E', 'LastName': 'Stojanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Niš, Niš, Serbia.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Stojiljković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Niš, Niš, Serbia.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Stanković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Niš, Niš, Serbia.'}, {'ForeName': 'Aaron T', 'Initials': 'AT', 'LastName': 'Scanlan', 'Affiliation': 'Human Exercise and Training Laboratory, School of Health, Medical and Applied Sciences, Central Queensland University, Rockhampton, Australia.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Dalbo', 'Affiliation': 'Human Exercise and Training Laboratory, School of Health, Medical and Applied Sciences, Central Queensland University, Rockhampton, Australia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Milanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Niš, Niš, Serbia.'}]",Journal of exercise science and fitness,['10.1016/j.jesf.2020.05.001']
2454,32922524,"Penetration of topical diclofenac into synovial tissue and fluid of osteoarthritic knees: a multicenter, randomized, placebo-controlled, pharmacokinetic study.","Background


Topical diclofenac, a nonsteroidal anti-inflammatory drug, has proven efficacy and safety in the management of osteoarthritis pain. We investigated penetration of topical diclofenac into knee synovial tissue and fluid (primary objective) and evaluated relative exposure in the knee  versus  plasma (secondary objective).
Methods


In this phase I, double-blind, multicenter study, patients scheduled for arthroplasty for end-stage knee osteoarthritis were randomly assigned 2:1 to 4 g diclofenac diethylamine 2.32% w/w gel (92.8 mg diclofenac diethylamine, equivalent to 74.4 mg diclofenac, per application) or placebo gel, applied to the affected knee by a trained nurse/designee every 12 h for 7 days before surgery. Diclofenac concentrations were measured in synovial tissue, synovial fluid and plasma from samples obtained during surgery ⩾12 h after last application. Treatment-emergent adverse events (TEAEs) were evaluated.
Results


Evaluable synovial tissue or fluid samples were obtained from 45 (diclofenac  n  = 29; placebo  n  = 16) of 47 patients. All diclofenac-treated participants had measurable diclofenac concentrations in synovial tissue [geometric mean 1.57 (95% confidence interval (CI) 1.12, 2.20) ng/g] and fluid [geometric mean 2.27 (95% CI 1.87, 2.76) ng/ml] ⩾12 h after the last dose. Geometric mean (95% CI) ratio of diclofenac in synovial tissue:plasma was 0.32 (0.23, 0.45) and in synovial fluid:plasma was 0.46 (0.40, 0.54). TEAE rates were similar for diclofenac (55.2%) and placebo (58.8%); none were treatment related.
Conclusions


Topical diclofenac diethylamine 2.32% w/w gel penetrated into the osteoarthritic knee after repeated application and remained detectable in synovial tissue and fluid at the end of the final 12 h dosing cycle.",2020,"TEAE rates were similar for diclofenac (55.2%) and placebo (58.8%); none were treatment related.
","['patients scheduled for arthroplasty for end-stage knee osteoarthritis', 'synovial tissue', 'osteoarthritic knees']","['topical diclofenac', 'placebo', 'diclofenac diethylamine 2.32% w/w gel (92.8\u2009mg diclofenac diethylamine, equivalent to 74.4\u2009mg diclofenac, per application) or placebo gel', 'diclofenac', 'Topical diclofenac diethylamine']","['TEAE rates', 'synovial tissue and fluid', 'Geometric mean', 'Evaluable synovial tissue or fluid samples', 'Diclofenac concentrations', 'plasma', 'synovial fluid:plasma', 'synovial tissue, synovial fluid and plasma', 'diclofenac concentrations in synovial tissue']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0039099', 'cui_str': 'Synovial membrane'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0771369', 'cui_str': 'Diclofenac diethylammonium'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0039099', 'cui_str': 'Synovial membrane'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0438734', 'cui_str': 'Fluid sample'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0039097', 'cui_str': 'Synovial fluid'}]",,0.185905,"TEAE rates were similar for diclofenac (55.2%) and placebo (58.8%); none were treatment related.
","[{'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Seefried', 'Affiliation': 'Clinical Trial Unit, Orthopaedic Department, University Würzburg, Brettreichtstr 11, Würzburg, Bavaria 97074, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Blyth', 'Affiliation': 'Department of Orthopaedic Surgery, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Orthopaedic Surgery, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'McDonnell', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Frappin', 'Affiliation': 'GlaxoSmithKline Consumer Healthcare S.A., Nyon, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hagen', 'Affiliation': 'GlaxoSmithKline Consumer Healthcare S.A., Nyon, Switzerland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Maybaum', 'Affiliation': 'GSK Consumer Healthcare, Warren, NJ, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Moreira', 'Affiliation': 'GSK Consumer Healthcare, Warren, NJ, USA.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Pandit', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK.'}]",Therapeutic advances in musculoskeletal disease,['10.1177/1759720X20943088']
2455,32922577,The Effect of Massage on the Cardiac Autonomic Nervous System and Markers of Inflammation in Night Shift Workers: a Pilot Randomized Crossover Trial.,"Background


Shift work is a necessary part of many industries; however, it can have detrimental effects on health over time.
Purpose


This study investigated the effect of a massage intervention on the cardiac autonomic activity and blood inflammatory markers of healthy medical residents working night shifts.
Setting


This trial was conducted at British Columbia Children's and Women's Hospital between February 2014 and June 2016.
Participants


Included participants were generally healthy medical residents and were working rotating night shifts on a regular basis.
Research Design


This was a randomized, controlled, crossover, open-label trial (NCT02247089).
Interventions


Participants received either a 30-min massage intervention or reading control after consecutive periods of night shift.
Main Outcome Measures


The primary outcome was high frequency, a proxy for the cardiac parasympathetic activity, measured via heart rate variability. Secondary outcomes included other heart rate variability measures, blood markers of inflammation, and blood pressure.
Results


Twelve participants were recruited (nine female) with median age of 28 years. There was no significant difference between the massage intervention and the reading control for the primary outcome, (median relative change between pre- and postmassage [interquartile range]: 62% [-1 to 150], pre- and postreading: 14% [-10 to 51],  p  = .16). Similarly, there was no difference with respect to blood inflammatory markers and blood pressure. Median high frequency significantly increased between pre- and postmassage (185 vs. 358 ms 2 ,  p  = .04).
Conclusion


This pilot study found no statistically significant difference between the massage intervention and the reading control; however, we did observe a significant increase in median high frequency from before massage to after massage, indicative of increased parasympathetic activity. This study may help inform planning of larger trials evaluating massage interventions on the activity of the autonomic nervous system and managing shift work stress.",2020,"There was no significant difference between the massage intervention and the reading control for the primary outcome, (median relative change between pre- and postmassage [interquartile range]: 62% [-1 to 150], pre- and postreading: 14% [-10 to 51],  p  = .16).","['Participants\n\n\nIncluded participants were generally healthy medical residents and were working rotating night shifts on a regular basis', 'Twelve participants were recruited (nine female) with median age of 28 years', 'healthy medical residents working night shifts', ""British Columbia Children's and Women's Hospital between February 2014 and June 2016"", 'Night Shift Workers']","['30-min massage intervention or reading control after consecutive periods of night shift', 'massage intervention', 'Massage']","['high frequency, a proxy for the cardiac parasympathetic activity, measured via heart rate variability', 'heart rate variability measures, blood markers of inflammation, and blood pressure', 'parasympathetic activity', 'Median high frequency', 'median high frequency', 'blood inflammatory markers and blood pressure', 'cardiac autonomic activity and blood inflammatory markers']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0555008', 'cui_str': 'Night shift worker'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",12.0,0.0528204,"There was no significant difference between the massage intervention and the reading control for the primary outcome, (median relative change between pre- and postmassage [interquartile range]: 62% [-1 to 150], pre- and postreading: 14% [-10 to 51],  p  = .16).","[{'ForeName': 'Mir Sohail', 'Initials': 'MS', 'LastName': 'Fazeli', 'Affiliation': ""British Columbia Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Mir-Masoud', 'Initials': 'MM', 'LastName': 'Pourrahmat', 'Affiliation': ""British Columbia Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Massah', 'Affiliation': ""British Columbia Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': ""British Columbia Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Pascal M', 'Initials': 'PM', 'LastName': 'Lavoie', 'Affiliation': ""British Columbia Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Mirfarhang', 'Initials': 'M', 'LastName': 'Fazeli', 'Affiliation': ""British Columbia Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Esser', 'Affiliation': 'Vancouver College of Massage Therapy, Vancouver, Canada.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': ""British Columbia Children's Hospital Research Institute, Vancouver, Canada.""}]",International journal of therapeutic massage & bodywork,[]
2456,32922579,Comparison Between Classic and Light Touch Massage on Psychological and Physical Functional Variables in Athletes: a Randomized Pilot Trial.,"Background


Despite the general belief of the benefits and the widespread use of massage in sport field, there are limited empirical data on possible effectiveness of massage on psychological and physical functional variables.
Purpose


The main objective of the present study was to compare the effectiveness of classical and light touch massage on psychological and physical functional variables in athletes.
Setting


Athletic club of Valencia.
Participants


20 amateur athletes were recruited from two athletic clubs.
Research Design


A single-blind, randomized, pilot-placebo trial.
Intervention


The subjects were randomly allocated to two different groups: a) Massage group (MG) (n=10); b) Control group (CG) (n=10). The intervention period lasted one month (one session per week).
Main Outcome Measures


Assessment of the participants was performed at baseline and 24 hours following the completion of the intervention. Outcome measures included hip flexion, knee extension, and mood state.
Results


The results suggest that MG obtained better results on physical variables ( p  < .05). However, for both groups, trends suggest significant improvements in the overall mood state of the participants ( p  < .05).
Conclusion


Our results suggest that classic massage could be an effective intervention to improve functional physical variables in athletes. However, trends suggest that a light touch intervention could provoke improvements in physiological measures.",2020,"However, for both groups, trends suggest significant improvements in the overall mood state of the participants ( p  < .05).
","['Athletes', 'Participants\n\n\n20 amateur athletes were recruited from two athletic clubs', 'athletes']","['Classic and Light Touch Massage', 'Control group (CG', 'classical and light touch massage', 'classic massage', 'Massage group (MG']","['physical variables', 'Psychological and Physical Functional Variables', 'hip flexion, knee extension, and mood state', 'psychological and physical functional variables', 'overall mood state', 'functional physical variables']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}]","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0423553', 'cui_str': 'Light touch'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",20.0,0.0415172,"However, for both groups, trends suggest significant improvements in the overall mood state of the participants ( p  < .05).
","[{'ForeName': 'Gemma V', 'Initials': 'GV', 'LastName': 'Espí-López', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5. 46010 Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5. 46010 Valencia, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5. 46010 Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5. 46010 Valencia, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Inglés', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5. 46010 Valencia, Spain.'}]",International journal of therapeutic massage & bodywork,[]
2457,32922628,The Effects of Walking with a Load in the Heat on Physiological Responses among Military Reserve Female Cadets.,"This study aimed to investigate the effects of walking in a hot and humid environment while wearing a combat suit with a load on physiological responses among the Malaysian Military Reserve Officer Training Unit (ROTU) female cadets. Eight healthy female ROTU cadets (age: 21.3 ± 1.0 years old; height: 156.3 ± 4.9 cm; weight: 55.6 ± 7.5 kg) participated in this randomised, crossover trial. They walked for 1 h on a treadmill at 3 km.h -1  while carrying either 8.2 kg load (WL) or without load (WOL) in a room maintained at 30°C and 70% relative humidity. Heart rate, rate of perceived exertion (RPE), and tympanic temperature were recorded at regular intervals during the trials. Nude body weight was recorded before and after the walk to determine body weight loss and sweat rate. Urine samples were also collected before and after the walk to determine urine specific gravity of the participants. There was a significant main effect of time and interaction for heart rate ( p  < 0.001) during the experimental trials. Tympanic temperature was significantly higher at 60 th  min in WL trial ( p  < 0.05) compared to the WOL trial. Similarly, RPE was found to be significantly higher in WL trial ( p  < 0.01) compared to the WOL trial. However, the percentage of body weight loss and sweat rate was significantly different between trials ( p  < 0.05). Wearing a combat suit with a load showed significantly increased metabolic demands compared to wearing combat suit alone during prolonged walking in a hot and humid environment.",2020,Tympanic temperature was significantly higher at 60 th  min in WL trial ( p  < 0.05) compared to the WOL trial.,"['Malaysian Military Reserve Officer Training Unit (ROTU) female cadets', 'Military Reserve Female Cadets', 'Eight healthy female ROTU cadets (age: 21.3 ± 1.0 years old; height: 156.3 ± 4.9 cm; weight: 55.6 ± 7.5 kg']",[],"['time and interaction for heart rate', 'Nude body weight', 'Heart rate, rate of perceived exertion (RPE), and tympanic temperature', 'body weight loss and sweat rate', 'Tympanic temperature', 'percentage of body weight loss and sweat rate']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517859', 'cui_str': '7.5'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0025932', 'cui_str': 'Mouse, Nude'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",8.0,0.0475958,Tympanic temperature was significantly higher at 60 th  min in WL trial ( p  < 0.05) compared to the WOL trial.,"[{'ForeName': 'Nurul Atikah', 'Initials': 'NA', 'LastName': 'Shuhada', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, MALAYSIA.'}, {'ForeName': 'Marilyn L Y', 'Initials': 'MLY', 'LastName': 'Ong', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, MALAYSIA.'}, {'ForeName': 'Chee Keong', 'Initials': 'CK', 'LastName': 'Chen', 'Affiliation': 'Exercise and Sports Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, MALAYSIA.'}]",International journal of exercise science,[]
2458,32922649,The Effect of Timing and Type of Exercise on the Quality of Sleep in Trained Individuals.,"Sleep is an extremely important component for overall health and for a well-balanced training program. Recent studies have highlighted the interaction between sleep, recovery, and performance in elite and recreational athletes alike. Exercise has been known to affect the quality of sleep, nevertheless the impact is not well understood in the current research, particularly the effects of exercise timing and intensity on sleep quality. The purpose of this study was to understand if exercise timing and intensity significantly impact sleep quality among recreational exercisers. The participants involved were recreational exercisers who were self-grouped into an AM or PM exercise group. They participated in a seven-day quantitative, quasi-experimental, exploratory study wearing an Actigraph watch. The participant's intensity was also self-grouped into moderate intensity or high intensity based on criteria cut points. Data was analyzed using a factorial ANOVA to examine if there was a significant difference between exercise timing and intensity on sleep quality of the participants. There were no significant differences in sleep quality in either the time group (AM vs PM) or the intensity group (MOD vs VIG) within the four measures of sleep that were looked at throughout this study; total sleep time, sleep onset latency, sleep efficiency % and wake after sleep onset (TST, SOL, SE, and WASO). Results within both, the AM and PM group and the MOD and VIG group, results showed no significant differences. These results conclude that neither exercise intensity or timing had an effect on sleep quality.",2020,"There were no significant differences in sleep quality in either the time group (AM vs PM) or the intensity group (MOD vs VIG) within the four measures of sleep that were looked at throughout this study; total sleep time, sleep onset latency, sleep efficiency % and wake after sleep onset (TST, SOL, SE, and WASO).","['Trained Individuals', 'participants involved were recreational exercisers who were self-grouped into an AM or PM exercise group', 'recreational exercisers']",['Timing and Type of Exercise'],"['Quality of Sleep', 'sleep quality', 'total sleep time, sleep onset latency, sleep efficiency % and wake after sleep onset (TST, SOL, SE, and WASO']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0205208', 'cui_str': 'Solid'}]",,0.0283884,"There were no significant differences in sleep quality in either the time group (AM vs PM) or the intensity group (MOD vs VIG) within the four measures of sleep that were looked at throughout this study; total sleep time, sleep onset latency, sleep efficiency % and wake after sleep onset (TST, SOL, SE, and WASO).","[{'ForeName': 'Victoria N', 'Initials': 'VN', 'LastName': 'Burgess', 'Affiliation': 'College of Human Performance, Concordia University, Chicago, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Antonio', 'Affiliation': 'Department of Health and Human Performance, Nova Southeastern University, Davie, FL, USA.'}, {'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Bland', 'Affiliation': 'College of Human Performance, Concordia University, Chicago, IL, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'College of Human Performance, Concordia University, Chicago, IL, USA.'}, {'ForeName': 'Jaime L', 'Initials': 'JL', 'LastName': 'Tartar', 'Affiliation': 'Department of Psychology and Neuroscience, Nova Southeastern University, Davie, FL, USA.'}, {'ForeName': 'Bridget F', 'Initials': 'BF', 'LastName': 'Melton', 'Affiliation': 'College of Human Performance, Concordia University, Chicago, IL, USA.'}]",International journal of exercise science,[]
2459,32922650,A Single Bout of Foam Rolling Increases Flexibility of the Hip Adductor Muscles without Compromising Strength.,"Foam rolling (FR) is a method of self-myofascial release (SMR) implemented to reduce tension in underlying soft tissue, leading to increased range of motion (ROM). The hip adductor muscles of the groin are commonly less flexible and often a site for soft tissue injuries. Limited research has been done to determine the most effective flexibility exercises to increase ROM in the groin muscles prior to exercise without comprising strength. The purpose was to determine the effect of an acute bout of FR on passive groin flexibility and strength. Randomized crossover study with 3 × 2 (Condition × Time) repeated measures ANOVA statistical design. 40 volunteers ( n  = 20 males;  n  = 20 females) with limited flexibility in groin ROM participated. Following warm-up, maximal voluntary isometric contraction (MVC) and static ROM were measured pre and postintervention. Conditions included 60 seconds of FR, SS, and CON. The Condition × Time interaction was not significant for MVC or ROM. A main effect of time showed a significant increase in ROM from pre to post for FR (1.2°,  p  < 0.001), SS (1.0°,  p  < 0.001), and CON (0.5°,  p  = 0.039). No significant changes in MVC were observed for FR from pre to post ( p  > 0.05), whereas SS and CON both increased ( p  < 0.05). An increase in passive groin ROM after acute bouts of SMR or SS without compromising MVC was observed. This suggests that 60 seconds of FR may be employed before exercise to improve flexibility without strength decrement.",2020,A main effect of time showed a significant increase in ROM from pre to post for FR,['40 volunteers ( n  = 20 males;  n  = 20 females) with limited flexibility in groin ROM participated'],"['FR', 'Foam rolling (FR']","['flexibility without strength decrement', 'MVC', 'SS and CON', 'SS', 'FR, SS, and CON', 'passive groin flexibility and strength', 'passive groin ROM', 'ROM', 'maximal voluntary isometric contraction (MVC) and static ROM']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",40.0,0.0251442,A main effect of time showed a significant increase in ROM from pre to post for FR,"[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Connolly', 'Affiliation': 'Herbert H. and Grace A. Dow College of Health Professions, School of Health Sciences, Division of Exercise Science, Central Michigan University, Mt. Pleasant, MI, USA.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Hammer', 'Affiliation': 'Herbert H. and Grace A. Dow College of Health Professions, School of Health Sciences, Division of Exercise Science, Central Michigan University, Mt. Pleasant, MI, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Powell', 'Affiliation': 'Herbert H. and Grace A. Dow College of Health Professions, School of Health Sciences, Division of Exercise Science, Central Michigan University, Mt. Pleasant, MI, USA.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': ""O'Connor"", 'Affiliation': 'Herbert H. and Grace A. Dow College of Health Professions, School of Health Sciences, Division of Exercise Science, Central Michigan University, Mt. Pleasant, MI, USA.'}]",International journal of exercise science,[]
2460,32922681,Interrupting traumatic memories in the emergency department: a randomized controlled pilot study.,"Background


The hours immediately following a traumatic event may present a window of opportunity to interrupt the consolidation of memories of the traumatic event, and this may prevent PTSD development. This theory has been validated in a series of analogue studies, showing that a visuo-spatial task reduces intrusive memories, however clinical studies are scarce.
Objective


This pilot RCT examined the use of a semi-immersive Virtual Reality visuospatial task, as an intervention to interrupt memory consolidation, in the Emergency Department (ED) in the immediate hours following a traumatic event. We hypothesised that participants who had received the intervention would present with lower levels of PTSD symptoms than the control group who received no intervention.
Method


Seventy-seven adult survivors of traumatic events, meeting study criteria, were recruited in the ED of a Level III Trauma Centre. Survivors arrived at the ED less than one hour, on average, after the trauma. After signing informed consent, participants were randomized to the SnowWorld intervention or control group. Both groups completed self-report questionnaires, and the intervention group used SnowWorld for up to 10 minutes.
Results


No significant differences between the intervention and control groups were found regarding PTSD symptom levels two weeks and six months following the traumatic event.
Conclusions


These results add to the growing literature examining the use of a concurrent task to reduce intrusions following a traumatic event. In contrast to previous clinical studies, this study did not show significant group differences; however, it replicates an analogue study that used a specifically developed app. Further studies are needed to elucidate possible reasons for these conflicting results.",2020,"No significant differences between the intervention and control groups were found regarding PTSD symptom levels two weeks and six months following the traumatic event.
","['Method\n\n\nSeventy-seven adult survivors of traumatic events, meeting study criteria, were recruited in the ED of a Level III Trauma Centre']","['SnowWorld intervention or control group', 'semi-immersive Virtual Reality visuospatial task']","['PTSD symptoms', 'PTSD symptom levels']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",77.0,0.0354361,"No significant differences between the intervention and control groups were found regarding PTSD symptom levels two weeks and six months following the traumatic event.
","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Freedman', 'Affiliation': 'School of Social Work, Bar Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Renana', 'Initials': 'R', 'LastName': 'Eitan', 'Affiliation': 'Department of Medical Neurobiology, The Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Weiniger', 'Affiliation': 'Division of Anesthesia, Critical Care and Pain, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv, Israel.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1750170']
2461,32922686,Early posttraumatic autonomic and endocrine markers to predict posttraumatic stress symptoms after a preventive intervention with oxytocin.,"Background


Efficient prevention of posttraumatic stress disorder (PTSD) needs to target individuals with an increased risk for adverse outcome after trauma. Prognostic or prescriptive biological markers assessed early posttrauma may inform personalized treatment recommendations.
Objective


To test prognostic and prescriptive effects of early (posttraumatic) autonomic and endocrine markers on PTSD symptom development.
Method


Autonomic and endocrine markers were assessed within 12 days posttrauma and before treatment initiation within a randomized placebo-controlled trial investigating repeated oxytocin administration as preventive intervention for PTSD. Linear mixed effects models were used to test the effects of heart rate (variability), resting cortisol, morning cortisol and cortisol awakening response (CAR), cortisol suppression by dexamethasone and resting oxytocin on PTSD symptoms 1.5, 3 and 6 months posttrauma in men ( n  = 54), women using hormonal contraception ( n  = 27) and cycling women ( n  = 19).
Results


We found significant prognostic effects of resting oxytocin and cortisol suppression. In women using hormonal contraception, higher oxytocin was associated with higher PTSD symptoms across follow-up. Stronger cortisol suppression by dexamethasone, reflecting increased glucocorticoid receptor feedback sensitivity, was associated with lower PTSD symptoms across follow-up in men, but with higher symptoms at 1.5 months in women using hormonal contraception. These effects were independent of treatment condition. No further significant prognostic or prescriptive effects were detected.
Conclusion


Our exploratory study indicates that resting oxytocin and glucocorticoid receptor feedback sensitivity early posttrauma are associated with subsequent PTSD symptom severity. Notably, prognostic effects depended on sex and hormonal contraception use, emphasizing the necessity to consider these factors in biomedical PTSD research.",2020,"Stronger cortisol suppression by dexamethasone, reflecting increased glucocorticoid receptor feedback sensitivity, was associated with lower PTSD symptoms across follow-up in men, but with higher symptoms at 1.5 months in women using hormonal contraception.","['men ( n  =\xa054), women using hormonal contraception ( n  =\xa027) and cycling women ( n  =\xa019']","['dexamethasone', 'dexamethasone and resting oxytocin', 'placebo', 'oxytocin']","['PTSD symptoms', 'heart rate (variability), resting cortisol, morning cortisol and cortisol awakening response (CAR), cortisol suppression', 'glucocorticoid receptor feedback sensitivity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid receptor'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0412782,"Stronger cortisol suppression by dexamethasone, reflecting increased glucocorticoid receptor feedback sensitivity, was associated with lower PTSD symptoms across follow-up in men, but with higher symptoms at 1.5 months in women using hormonal contraception.","[{'ForeName': 'Sinha', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Amsterdam University Medical Centers, Location Academic Medical Center, Department of Psychiatry, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'van Zuiden', 'Affiliation': 'Amsterdam University Medical Centers, Location Academic Medical Center, Department of Psychiatry, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jessie L', 'Initials': 'JL', 'LastName': 'Frijling', 'Affiliation': 'Amsterdam University Medical Centers, Location Academic Medical Center, Department of Psychiatry, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Saskia B J', 'Initials': 'SBJ', 'LastName': 'Koch', 'Affiliation': 'Amsterdam University Medical Centers, Location Academic Medical Center, Department of Psychiatry, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nawijn', 'Affiliation': 'Amsterdam University Medical Centers, Location Academic Medical Center, Department of Psychiatry, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rinde L W', 'Initials': 'RLW', 'LastName': 'Yildiz', 'Affiliation': 'Amsterdam University Medical Centers, Location Academic Medical Center, Department of Psychiatry, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schumacher', 'Affiliation': 'Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Knaevelsrud', 'Affiliation': 'Division of Clinical Psychological Intervention, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Jos A', 'Initials': 'JA', 'LastName': 'Bosch', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dick J', 'Initials': 'DJ', 'LastName': 'Veltman', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centers, Location VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Olff', 'Affiliation': 'Amsterdam University Medical Centers, Location Academic Medical Center, Department of Psychiatry, Amsterdam Neuroscience, University of Amsterdam, Amsterdam, The Netherlands.'}]",European journal of psychotraumatology,['10.1080/20008198.2020.1761622']
2462,32928567,Is Myofascial Release Therapy Cost-Effective When Compared With Manual Therapy to Treat Workers' Mechanical Neck Pains?,"OBJECTIVE


The aim of this study was to do a cost-benefit analysis of myofascial release therapy (MRT) compared to manual therapy (MT) for treating occupational mechanical neck pain.
METHODS


Variables regarding the outcomes of the intervention were intensity of neck pain, cervical disability, quality of life, craniovertebral angle, and ranges of cervical motion. Costs were assessed based on a social perspective using diary costs. Between-groups differences in average cost, cost-effectiveness, and cost-utility ratios were assessed using bootstrap parametric techniques. The economic cost-benefit evaluation was with regard to an experimental parallel group study design. There were 59 participants.
RESULTS


Myofascial released therapy showed significant improvement over MT for cervical mobility (side bending, rotation, and craniovertebral angle). The total cost of MRT was approximately 20% less (-$519.81; 95% confidence interval, -$1193.67 to $100.31) than that of MT, although this was not statistically significant. Cost-effectiveness and cost-utility ratios showed that MRT could be associated with lower economic costs.
CONCLUSION


With probabilities of 93.9% and 95.8%, MRT seems to be cost-effective for treating mechanical neck pain without the need to add any additional cost to obtain a better clinical benefit. Consequently, we believe it could be included in the clinical practice guidelines of different Spanish health care institutions.",2020,"RESULTS


Myofascial released therapy showed significant improvement over MT for cervical mobility (side bending, rotation, and craniovertebral angle).",['59 participants'],"['myofascial release therapy (MRT', 'manual therapy (MT', 'MRT', 'Manual Therapy']","['Cost-effectiveness and cost-utility ratios', 'intensity of neck pain, cervical disability, quality of life, craniovertebral angle, and ranges of cervical motion', 'MT for cervical mobility (side bending, rotation, and craniovertebral angle', 'total cost of MRT', 'average cost, cost-effectiveness, and cost-utility ratios']",[],"[{'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.0933698,"RESULTS


Myofascial released therapy showed significant improvement over MT for cervical mobility (side bending, rotation, and craniovertebral angle).","[{'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Rodríguez-Fuentes', 'Affiliation': 'FREMAP-Collaborative Mutual Society with the Social Security Institute No. 61, A Coruña, Spain. Electronic address: irismacoli@uvigo.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'De Toro', 'Affiliation': 'Department of Medicine, University of A Coruña, Grupo de Terapia Celular y Medicina Regenerativa (TCMR-CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rodríguez-Fuentes', 'Affiliation': 'Department of Functional Biology and Health Sciences, University of Vigo, HealthyFit Research Group, Instituto de Investigación Sanitaria Galicia Sur (IISGS), Pontevedra, Spain.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Functional Biology and Health Sciences, University of Vigo, HealthyFit Research Group, Instituto de Investigación Sanitaria Galicia Sur (IISGS), Pontevedra, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Meijide-Faílde', 'Affiliation': 'Department of Medicine, University of A Coruña, Grupo de Terapia Celular y Medicina Regenerativa (TCMR-CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain.'}, {'ForeName': 'Isaac M', 'Initials': 'IM', 'LastName': 'Fuentes-Boquete', 'Affiliation': 'Department of Medicine, University of A Coruña, Grupo de Terapia Celular y Medicina Regenerativa (TCMR-CHUAC), Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2018.11.037']
2463,32928570,Cognitive Behavioral Therapy With Stabilization Exercises Affects Transverse Abdominis Muscle Thickness in Patients With Chronic Low Back Pain: A Double-Blinded Randomized Trial Study.,"OBJECTIVE


Nonspecific chronic low back pain (NCLBP) is a major public health and global socioeconomic burden with a variety of symptoms, such as fear-avoidance behaviors. This study aimed to evaluate the effect of cognitive behavioral therapy (CBT) associated with stabilization exercise (SE) on thickness of transverse abdominis (TrA) muscle in patients with NCLBP.
METHODS


Forty patients with NCLBP were randomly assigned into experimental CBT associated with SE (n = 20) and control groups without SE (n = 20). Transverse abdominis muscle thickness was assessed during abdominal drawing in maneuver (ADIM) and active straight leg raise (ASLR) of the right lower limb using ultrasound imaging. Fear-avoidance belief and disability were evaluated using a fear-avoidance belief questionnaire (FABQ) and a Roland-Morris disability questionnaire (RMDQ) before and after intervention.
RESULTS


Mixed-model analysis of variance indicated that the effect of time was significant for the right and left TrA contraction thickness during ADIM and left TrA contraction thickness during ASLR (P < .05). However, the experimental group exhibited higher right and left TrA muscle thickness compared with the control group during ADIM (P = .001). Moreover, there were no significant differences between groups in the thickness of TrA muscle during ASLR (P > .05). The effect of time was significant for FABQ (P = .02) and RMDQ (P = .01); however, the effect of group was significant for the FABQ after intervention (P = .04).
CONCLUSIONS


Stabilization exercise associated with CBT is more effective than SE alone in improving fear avoidance belief and in increasing the thickness of the TrA muscle during ADIM task.",2020,"The effect of time was significant for FABQ (P = .02) and RMDQ (P = .01); however, the effect of group was significant for the FABQ after intervention (P = .04).
","['Patients With Chronic Low Back Pain', 'Forty patients with NCLBP', 'patients with NCLBP', 'Nonspecific chronic low back pain (NCLBP']","['CBT associated with SE (n\u202f=\u202f20) and control groups without SE', 'stabilization exercise (SE', 'cognitive behavioral therapy (CBT', 'Cognitive Behavioral Therapy With Stabilization Exercises']","['Transverse Abdominis Muscle Thickness', 'right and left TrA contraction thickness during ADIM and left TrA contraction thickness', 'FABQ', 'higher right and left TrA muscle thickness', 'Fear-avoidance belief and disability', 'thickness of TrA muscle during ASLR', 'Transverse abdominis muscle thickness', 'fear-avoidance belief questionnaire (FABQ) and a Roland-Morris disability questionnaire (RMDQ', 'thickness of transverse abdominis (TrA) muscle', 'RMDQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}]",40.0,0.045285,"The effect of time was significant for FABQ (P = .02) and RMDQ (P = .01); however, the effect of group was significant for the FABQ after intervention (P = .04).
","[{'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rozita', 'Initials': 'R', 'LastName': 'Hedayati', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: Hedayati@semums.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Hemati-Boruojeni', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Abri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Taghizadeh Delkhosh', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.03.015']
2464,32928579,"Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study.","BACKGROUND & AIMS


Sarcopenia is defined as a syndrome characterized by declines in skeletal muscle mass and strength or an alteration in physical function. Although some studies showed nutritional supplementation alone might have health benefits for older sarcopenic patients, their results were inconsistent and remain controversial. The objective of this study was to evaluate if a diet with high protein supplementation (Supp) can lead to better improvement than additional protein intake via dietary counseling (Diet) in maintaining the muscle mass and strength among sarcopenic elders.
METHODS


This was an open-label, parallel-group (Supp vs. Diet) trial. In total, 56 sarcopenic elders completed this study. All subjects were advised to achieve adequate protein intake (1.2-1.5 g/kg body weight/day). This amount of protein is recommended for the elderly and is thought to prevent or retard muscle loss due to aging. The diet group (n = 28) was recommended to consume an ordinary protein-rich diet via counselling whereas the Supp group (n = 28) received a vitamin D- and leucine-enriched whey protein supplement for 12 weeks. The appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake were evaluated after 4 and 12 weeks of the diet intervention.
RESULTS


Total energy and protein intake increased in both groups. The Supp group had higher intake than the Diet group. The AMMI increased in both groups, and handgrip strength improved in the Diet group. However, no significant differences in AMMI or handgrip strength were found between the two groups. Compared to the Diet group, the Supp group had better improvement in gait speed after 12 weeks of the supplement intervention especially in subjects younger than 75 years.
CONCLUSIONS


The AMMI can be improved as long as sufficient protein is consumed (1.2-1.5 g/kg body weight/day) in sarcopenic elders. Nutritional supplement allows the sarcopenic elderly to more conveniently meet their protein requirements. Supplementation with whey protein and vitamin D can further improve gait speed in elderly sarcopenic subjects, especially in the ""younger"" age group.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03860194.",2020,"The appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake were evaluated after 4 and 12 weeks of the diet intervention.
","['older adults', 'sarcopenic elders', 'older sarcopenic patients', 'elderly sarcopenic subjects', '56 sarcopenic elders']","['additional protein intake via dietary counseling (Diet', 'vitamin D- and leucine-enriched whey protein supplement', 'Nutritional supplement', 'diet with high protein supplementation (Supp', 'adequate dietary protein with whey protein, leucine, and\xa0vitamin D supplementation', 'ordinary protein-rich diet via counselling whereas the Supp group', 'Supplementation with whey protein and vitamin D']","['appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake', 'adequate protein intake', 'handgrip strength', 'Total energy and protein intake', 'AMMI', 'gait speed', 'AMMI or handgrip strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0331049', 'cui_str': 'Ammi'}]",56.0,0.0148331,"The appendicular muscle mass index (AMMI), handgrip strength, gait speed, and calorie and macronutrients intake were evaluated after 4 and 12 weeks of the diet intervention.
","[{'ForeName': 'Chih-Chien', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan; Department of Family Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Ming-Hsiung', 'Initials': 'MH', 'LastName': 'Shih', 'Affiliation': 'Department of Family Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan; Department of Communications Engineering, Yuan Ze University, Taoyuan City, Taiwan.'}, {'ForeName': 'Chih-Dao', 'Initials': 'CD', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Sung-Ling', 'Initials': 'SL', 'LastName': 'Yeh', 'Affiliation': 'School of Nutrition and Health Sciences, College of Nutrition, Taipei Medical University, Taipei, Taiwan. Electronic address: sangling@tmu.edu.tw.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.017']
2465,32928580,"The effectiveness of a weight-loss Mediterranean diet/lifestyle intervention in the management of obstructive sleep apnea: Results of the ""MIMOSA"" randomized clinical trial.","BACKGROUND & AIMS


Although continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA), lifestyle interventions have also emerged as complementary therapeutic choices. We aimed to explore whether the addition of a weight-loss Mediterranean diet/lifestyle intervention to OSA standard care, i.e. CPAP prescription and brief written healthy lifestyle advice, has an incremental effect on improving OSA severity, over the effect of standard care alone.
METHODS


We designed a parallel, randomized, controlled, superiority clinical trial. Eligible participants were adult, overweight men and women, diagnosed with moderate-to-severe OSA [apnea-hypopnea index (AHI)≥ 15 events/h] through an attended overnight polysomnography. Participants were blindly randomized to a standard care group (SCG, n = 65), a Mediterranean diet group (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All three study groups were prescribed with CPAP. The SCG additionally received written healthy lifestyle advice, while intervention arms were subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. The MLG also received counselling on physical activity and sleep habits. Polysomnographic data and OSA symptoms were evaluated pre- and post-intervention.
RESULTS


A total of 187 OSA patients were recruited. Seven patients were excluded post-randomization and 53/180 (29%) were lost to follow-up. No harms from the interventions applied were reported. According to intention-to-treat analysis (n = 180), mean (95% confidence interval) AHI change was -4.2 (-7.4, -1.0) for the SCG, -24.7 (-30.4, -19.1) for the MDG and -27.3 (-33.9, -20.6) for the MLG. Post-intervention age-, sex-, baseline- and CPAP use-adjusted AHI was significantly lower in the MDG and the MLG compared to the SCG (mean difference: -18.0, and -21.2, respectively, both P < 0.001), and the differences remained significant after further adjustment for body-weight change (P = 0.004 and 0.008, respectively). Other respiratory event indices, daytime sleepiness and insomnia were also significantly lower in both intervention arms compared to the SCG (all P < 0.05). The MLG only presented higher percent rapid-eye-movement sleep and lower daytime sleepiness compared to the MDG (both P < 0.05). Results were similar in the per-protocol analysis (n = 127).
CONCLUSIONS


A dietary/lifestyle intervention on top of standard care leads to greater improvements in OSA severity and symptomatology compared to standard care alone. Benefits are evident regardless of CPAP use and weight loss.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02515357, https://clinicaltrials.gov/ct2/show/NCT02515357.",2020,"Other respiratory event indices, daytime sleepiness and insomnia were also significantly lower in both intervention arms compared to the SCG (all P < 0.05).","['187 OSA patients were recruited', 'Eligible participants were adult, overweight men and women, diagnosed with moderate-to-severe OSA [apnea-hypopnea index (AHI)≥ 15 events/h] through an attended overnight polysomnography', 'obstructive sleep apnea']","['standard care group (SCG, n\xa0=\xa065), a Mediterranean diet group (MDG, n\xa0=\xa062) or a Mediterranean lifestyle group (MLG, n\xa0=\xa060', 'weight-loss Mediterranean diet/lifestyle intervention', 'continuous positive airway pressure (CPAP', 'baseline- and CPAP', 'CPAP']","['Polysomnographic data and OSA symptoms', 'OSA severity', 'OSA severity and symptomatology', 'AHI change', 'daytime sleepiness and insomnia', 'rapid-eye-movement sleep and lower daytime sleepiness', 'body-weight change', 'physical activity and sleep habits']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012694', 'cui_str': 'Cromolyn sodium'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0024443', 'cui_str': 'Madagascar'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0574375', 'cui_str': 'Malagasy language'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}]",187.0,0.0758424,"Other respiratory event indices, daytime sleepiness and insomnia were also significantly lower in both intervention arms compared to the SCG (all P < 0.05).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Georgoulis', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Yiannakouris', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kechribari', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Lamprou', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Perraki', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Vagiakis', 'Affiliation': 'Center of Sleep Disorders, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece.'}, {'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition & Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece. Electronic address: mkont@hua.gr.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.037']
2466,32925345,Incidence of and Factors Associated With Prolonged and Persistent Postoperative Opioid Use in Children 0-18 Years of Age.,"BACKGROUND


Long-term opioid use has negative health care consequences. Opioid-naïve adults are at risk for prolonged and persistent opioid use after surgery. While these outcomes have been examined in some adolescent and teenage populations, little is known about the risk of prolonged and persistent postoperative opioid use after common surgeries compared to children who do not undergo surgery and factors associated with these issues among pediatric surgical patients of all ages.
METHODS


Using a national administrative claims database, we identified 175,878 surgical visits by opioid-naïve children aged ≤18 years who underwent ≥1 of the 20 most common surgeries from each of 4 age groups between December 31, 2002, and December 30, 2017, and who filled a perioperative opioid prescription 30 days before to 14 days after surgery. Prolonged opioid use after surgery (filling ≥1 opioid prescription 90-180 days after surgery) was compared to a reference sample of 1,354,909 nonsurgical patients randomly assigned a false ""surgery"" date. Multivariable logistic regression models were used to estimate the association of surgical procedures and 22 other variables of interest with prolonged opioid use and persistent postoperative opioid use (filling ≥60 days' supply of opioids 90-365 days after surgery) for each age group.
RESULTS


Prolonged opioid use after surgery occurred in 0.77%, 0.76%, 1.00%, and 3.80% of surgical patients ages 0-<2, 2-<6, 6-<12, and 12-18, respectively. It was significantly more common in surgical patients than in nonsurgical patients (ages 0-<2: odds ratio [OR] = 4.6 [95% confidence interval (CI), 3.7-5.6]; ages 2-<6: OR = 2.5 [95% CI, 2.1-2.8]; ages 6-<12: OR = 2.1 [95% CI, 1.9-2.4]; and ages 12-18: OR = 1.8 [95% CI, 1.7-1.9]). In the multivariable models for ages 0-<12 years, few surgical procedures and none of the other variables of interest were associated with prolonged opioid use. In the models for ages 12-18 years, 10 surgical procedures and 5 other variables of interest were associated with prolonged opioid use. Persistent postoperative opioid use occurred in <0.1% of patients in all age groups.
CONCLUSIONS


Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare. Specific pediatric subpopulations (eg, older patients with a history of mood/personality disorder or chronic pain) may be at markedly higher risk.",2020,"Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare.","['Specific pediatric subpopulations (eg, older patients with a history of mood/personality disorder or chronic pain', 'pediatric surgical patients of all ages', '175,878 surgical visits by opioid-naïve children aged ≤18 years who underwent ≥1 of the 20 most common surgeries from each of 4 age groups between December 31, 2002, and December 30, 2017, and who filled a perioperative opioid prescription 30 days before to 14 days after surgery', 'Children 0-18 Years of Age']",[],['Persistent postoperative opioid use'],"[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",[],"[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0613172,"Some patient characteristics and surgeries are positively and negatively associated with prolonged opioid use in opioid-naïve children of all ages, but persistent opioid use is rare.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ward', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'De Souza', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Sun', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Bambos', 'Affiliation': 'From the Departments of Electrical Engineering.'}, {'ForeName': 'T Anthony', 'Initials': 'TA', 'LastName': 'Anderson', 'Affiliation': 'Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004823']
2467,32925421,A Randomized Controlled Trial of a Multimedia Patient Education Tool for Stress Versus Urgency Urinary Incontinence.,"OBJECTIVE


The aim of this study was to determine whether there was a difference in patient education when comparing traditional conversation-based patient counseling with multimedia-based patient counseling about stress and urgency urinary incontinence.
METHODS


Patients seeking treatment for urinary incontinence were randomized to traditional, conversation-based counseling from a physician regarding stress and urgency urinary incontinence (control group) or view a video (multimedia) as their counseling (treatment group). A vignette-based assessment of the patient's knowledge of stress and urgency urinary incontinence was administered as a pretest, immediate posttest, and 6- to 8-week delayed posttest. The Incontinence Impact Questionnaire, short form, was used to assess quality of life and was administered at the initial visit and at the 6- to 8-week follow-up call. Patient satisfaction was recorded at the end of the initial visit using a continuous visual analog scale, and health literacy was evaluated using the Rapid Estimate of Adult Literacy in Medicine-Short Form or Short Assessment of Health Literacy-Spanish.
RESULTS


In the 98 participants, immediate posttest scores trended toward significance between the control and treatment groups (P = 0.086). This trend was lost at the delayed posttest (P = 0.122). Both methods of education showed a significant difference between pretest, immediate posttest, and delayed posttest (P < 0.001). There were no demographic differences between groups.
CONCLUSIONS


Multimedia-based patient education represents an effective method of providing patient education regarding urinary incontinence because those who received video education showed comparable comprehension of this topic when compared with standard physician counseling. Video education can feasibly be used as an alternative to, or in conjunction with, current patient education practices in a urogynecology setting.",2020,"Both methods of education showed a significant difference between pretest, immediate posttest, and delayed posttest (P < 0.001).",['Patients seeking treatment for urinary incontinence'],"['Multimedia Patient Education Tool', 'traditional, conversation-based counseling from a physician regarding stress and urgency urinary incontinence (control group) or view a video (multimedia) as their counseling', 'traditional conversation-based patient counseling with multimedia-based patient counseling']","['quality of life', 'continuous visual analog scale, and health literacy', 'Patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0600047', 'cui_str': 'Patient counseled'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",98.0,0.0547623,"Both methods of education showed a significant difference between pretest, immediate posttest, and delayed posttest (P < 0.001).","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'From the Division of Female Pelvic Medicine and Reconstructive Surgery, Cooper University Hospital, Camden, NJ.'}, {'ForeName': 'Elisabeth A', 'Initials': 'EA', 'LastName': 'Plotner', 'Affiliation': 'Cooper Medical School of Rowan University, Camden, NJ.'}, {'ForeName': 'Shefali', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Spectrum Health Medical Group, Grand Rapids, MI.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Hunter', 'Affiliation': 'Cooper Research Institute, Camden, NJ.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Spector', 'Affiliation': 'From the Division of Female Pelvic Medicine and Reconstructive Surgery, Cooper University Hospital, Camden, NJ.'}, {'ForeName': 'Lioudmila', 'Initials': 'L', 'LastName': 'Lipetskaia', 'Affiliation': 'From the Division of Female Pelvic Medicine and Reconstructive Surgery, Cooper University Hospital, Camden, NJ.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000946']
2468,32925435,Patient satisfaction with intravenous regional anaesthesia or an axillary block for minor ambulatory hand surgery: A randomised controlled study.,"BACKGROUND


Intravenous regional anesthesia (IVRA) and the axillary brachial plexus block are popular alternatives to general anaesthesia in ambulatory hand surgery. Although both have proven their effectiveness, patients' preferences have never been evaluated.
OBJECTIVES


We investigated patient satisfaction with both techniques and hypothesised that satisfaction after IVRA is noninferior compared with axillary brachial plexus block.
DESIGN


A prospective, randomised controlled trial.
SETTING


Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from September 2016 to November 2017.
PATIENTS


One hundred and twenty adults undergoing minor ambulatory hand surgery were included in this study.
INTERVENTION


Patients received either IVRA with 300 mg lidocaine or an axillary block with 280 mg mepivacaine.
MAIN OUTCOME MEASURES


The primary endpoint was the evaluation of patient satisfaction using the 'Evaluation du Vécu de l'Anésthesie Locoregional' (EVAN-LR) questionnaire. Secondary outcomes included different procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics during the first 24 h.
RESULTS


Noninferiority of IVRA was shown for the median [IQR] total score on the EVAN-LR questionnaire, IVRA-group: 92 [87 to 96] vs. axillary brachial plexus block-group: 91[87 to 97]; Hodges--Lehmann estimator (95% confidence interval (CI)] for the shift: -0.25 (-2.60 to 2.20). Induction of anaesthesia and time to discharge, requiring partial recovery of the motor block, were significantly longer in the axillary brachial plexus block group. The IVRA-group had a lower block quality, a higher incidence of tourniquet-discomfort and higher median intra-operative and postoperative pain scores on day 0; 0 [0 to 2] vs. 0 [0 to 0] and 0.8 [0 to 1.8] vs. 0 [0 to 0.25], respectively, but no increase in the need for supplementary analgesics or conversion rate to general anaesthesia.
CONCLUSION


IVRA and axillary brachial plexus block result in comparably high patient satisfaction in ambulatory hand surgery.
CLINICAL TRIAL REGISTRATION


EudraCT 2016-002325-11.",2020,"Secondary outcomes included different procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics during the first 24 h.
RESULTS


Noninferiority of IVRA was shown for the median [IQR] total score on the EVAN-LR questionnaire, IVRA-group: 92 [87 to 96] vs. axillary brachial plexus block-group: 91[87 to 97]; Hodges--Lehmann estimator (95% confidence interval (CI)] for the shift: -0.25 (-2.60 to 2.20).","['Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from September 2016 to November 2017', 'One hundred and twenty adults undergoing minor ambulatory hand surgery were included in this study']","['intravenous regional anaesthesia or an axillary block for minor ambulatory hand surgery', 'IVRA with 300\u200amg lidocaine or an axillary block with 280\u200amg mepivacaine', 'Intravenous regional anesthesia (IVRA', 'EudraCT']","['median [IQR] total score on the EVAN-LR questionnaire', 'block quality', 'tourniquet-discomfort and higher median intra-operative and postoperative pain scores', 'Hodges--Lehmann estimator', ""evaluation of patient satisfaction using the 'Evaluation du Vécu de l'Anésthesie Locoregional' (EVAN-LR) questionnaire"", 'Induction of anaesthesia and time to discharge, requiring partial recovery of the motor block', 'procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0175952', 'cui_str': 'Day care center'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0401805', 'cui_str': 'Estimator'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",120.0,0.142823,"Secondary outcomes included different procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics during the first 24 h.
RESULTS


Noninferiority of IVRA was shown for the median [IQR] total score on the EVAN-LR questionnaire, IVRA-group: 92 [87 to 96] vs. axillary brachial plexus block-group: 91[87 to 97]; Hodges--Lehmann estimator (95% confidence interval (CI)] for the shift: -0.25 (-2.60 to 2.20).","[{'ForeName': 'An', 'Initials': 'A', 'LastName': 'Teunkens', 'Affiliation': 'From the Department of Anesthesiology, University Hospitals Leuven, Herestraat (AT, KV, MV de V, SR), I-Biostat, KU Leuven- University of Leuven, Kapucijnenvoer (AB), Department of Orthopedics, University Hospitals Leuven, Herestraat (ID) and Department of Cardiovascular Sciences, KU Leuven - University of Leuven, Herestraat, Leuven, Belgium (AT, MV de V, SR).'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Vermeulen', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': ''}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Degreef', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Van de Velde', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001259']
2469,32925478,Quality of dispatcher-assisted vs. automated external defibrillator-guided cardiopulmonary resuscitation: a randomised simulation trial.,"BACKGROUND


Quality of hands-only cardiopulmonary resuscitation (CPR) is an important determinant of resuscitation outcome for cardiac arrest patients cared for by lay rescuers. We designed a simulation trial to assess and compare the quality of CPR among untrained lay people under two different scenarios: automated external defibrillator (AED)-guided and dispatcher-assisted CPR.
PATIENTS AND METHODS


A simulation study was performed involving 42 volunteers selected by non-probabilistic sampling. Participants were randomized into two CPR simulation scenarios with a manikin: (A) AED-guided CPR and (T) dispatcher-assisted CPR. The quality of CPR was evaluated by metric monitoring of the chest compressions and timing of actions. Content analysis of the telephone instructions was performed by two independent researchers using a checklist.
RESULTS


CPR was started in 20 of the 21 cases in scenario A and in all cases in scenario T. In total, 12 053 chest compressions were applied, 57.6% corresponding to scenario A. The proportion of compressions that were of an adequate depth was low in both cases, 15.3% in scenario A vs. 31.7% in scenario T (P < 0.001), while complete chest recoil was allowed in 66 and 72% (P < 0.001) of compressions, respectively. The AED advised to shock 91 times, and shocks were delivered in all cases.
CONCLUSIONS


Although guided CPR helps untrained people to initiate resuscitation manoeuvres, the quality of CPR was poor in both groups. Telephone guidance improved the proportion of compressions that achieved adequate chest compression and recoil but did not optimise the compression rate.",2020,Telephone guidance improved the proportion of compressions that achieved adequate chest compression and recoil but did not optimise the compression rate.,"['cardiac arrest patients cared for by lay rescuers', '42 volunteers selected by non-probabilistic sampling', 'untrained lay people under two different scenarios']","['hands-only cardiopulmonary resuscitation (CPR', 'dispatcher-assisted vs. automated external defibrillator-guided cardiopulmonary resuscitation', 'CPR simulation scenarios with a manikin: (A) AED-guided CPR and (T) dispatcher-assisted CPR', 'automated external defibrillator (AED)-guided and dispatcher-assisted CPR', 'Telephone guidance']","['proportion of compressions', 'complete chest recoil', 'quality of CPR']","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",42.0,0.0194278,Telephone guidance improved the proportion of compressions that achieved adequate chest compression and recoil but did not optimise the compression rate.,"[{'ForeName': 'Sendoa', 'Initials': 'S', 'LastName': 'Ballesteros-Peña', 'Affiliation': 'Biocruces Bizkaia Health Research Institute. Barakaldo.'}, {'ForeName': 'Irrintzi', 'Initials': 'I', 'LastName': 'Fernández-Aedo', 'Affiliation': 'Hospital de Basurto. Bilbao-Basurto Integrated Healthcare Organisation. Bilbao.'}, {'ForeName': 'Gorka', 'Initials': 'G', 'LastName': 'Vallejo-De la Hoz', 'Affiliation': 'Biocruces Bizkaia Health Research Institute. Barakaldo.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Etayo Sancho', 'Affiliation': 'Urduliz Advanced Life Support Unit. Bizkaia.'}, {'ForeName': 'Asier', 'Initials': 'A', 'LastName': 'Alonso Pinillos', 'Affiliation': 'Emergency Medical Service of the Basque Health Service. Bizkaia, Spain.'}]",European journal of emergency medicine : official journal of the European Society for Emergency Medicine,['10.1097/MEJ.0000000000000715']
2470,32925628,Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women.,"OBJECTIVE


To evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.
METHODS


We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested.
RESULTS


Of 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05).
CONCLUSION


Compared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01990612.",2020,Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60).,"['low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management', '6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis', 'Low-Risk Nulliparous Women']","['Elective Labor Induction at 39 Weeks of Gestation', 'Expectant Management']","['Decreased risk of third- or fourth-degree perineal laceration', 'BMI', 'Frequency of the perinatal composite', 'body mass index (BMI', 'Increased risk of postpartum hemorrhage', 'perinatal composite outcome', 'adverse outcomes', 'reduced risk of adverse perinatal outcome', 'adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage', 'postpartum hemorrhage']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1275806', 'cui_str': 'Fourth degree perineal laceration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}]",6096.0,0.346142,Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60).,"[{'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ""Departments of Obstetrics and Gynecology, Stanford University, Stanford, California, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004055']
2471,32925629,Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.,"OBJECTIVE


To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
METHODS


This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.
RESULTS


From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59).
CONCLUSION


Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation.
CLINICAL TRIAL REGISTRATION


ClinialTrials.gov, NCT01990612.",2020,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","['low-risk nulliparous women', 'From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial', 'Younger women']",[],[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],[],7112.0,0.369739,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ""Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'de Voest', 'Affiliation': ''}, {'ForeName': 'Sabine Z', 'Initials': 'SZ', 'LastName': 'Bousleiman', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Allard', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Felecia', 'Initials': 'F', 'LastName': 'Ortiz', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bartholomew', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bickus', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003998']
2472,32925634,Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation.,"OBJECTIVE


To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation.
METHODS


We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor.
RESULTS


Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management.
CONCLUSION


Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their ""customized"" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01990612.",2020,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","['Nulliparous Women at 39 Weeks of Gestation', 'counsel nulliparous women', 'low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation', 'low-risk nulliparous women', '6,106 women enrolled in the trial', 'Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the']","['Vaginal Delivery With Induction of Labor and Expectant Management', 'expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm', 'expectant management', 'planned elective induction of labor']","['Vaginal delivery', 'chance of vaginal delivery']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]",6106.0,0.0517142,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ""Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, and Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004046']
2473,32925650,Outcomes of Secondary Intraocular Lens Implantation in the Infant Aphakia Treatment Study.,"PURPOSE


To report outcomes of secondary intraocular lens (IOL) implantation in the Infant Aphakia Treatment Study (IATS) SETTING:: Multicenter clinical practice DESIGN:: Secondary analysis of patients enrolled in a randomized clinical trial METHODS:: Details regarding all secondary IOL surgeries conducted in children enrolled in the IATS were compiled. We evaluated visual outcomes, refractive outcomes, and adverse events at age 10 ½ years. Comparisons were made to eyes that remained aphakic and to eyes randomized to primary IOL placement.
RESULTS


55/57 patients randomized to aphakia with contact lens correction were seen for the 10 ½ year study visit; 24/55 eyes (44%) had secondary IOL surgery. Median age at IOL surgery was 5.4 years (range 1.7 to 10.3 years). Mean absolute prediction error was 1.0 ± 0.7D. At age 10 ½ years, the median log MAR VA was 0.9 (range 0.2 to 1.7), similar to VA in the 31 eyes still aphakic (0.8, range 0.1 to 2.9); the number of eyes with stable or improved VA scores between the 4 ½ and 10 ½ year study visits was also similar (78% secondary IOL eyes, 84% aphakic eyes). For eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age 10 ½ years was -3.2 ±2.7D (range -9.9D to 1.1D), compared to -5.5 ±6.6 D (n=53, range -26.5 to 3.0D) in eyes with primary IOL (p=0.03).
CONCLUSIONS


Delayed IOL implantation allows a more predictable refractive outcome at age 10 ½ years, though the range of refractive error is still large.",2020,"For eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age 10 ½ years was -3.2 ±2.7D (range -9.9D to 1.1D), compared to -5.5 ±6.6 D (n=53, range -26.5 to 3.0D) in eyes with primary IOL (p=0.03).
","['55/57 patients randomized to', 'Median age at IOL surgery was 5.4 years (range 1.7 to 10.3 years', 'children enrolled in the IATS were compiled']","['aphakia with contact lens correction', 'Secondary Intraocular Lens Implantation', 'Delayed IOL implantation', 'secondary intraocular lens (IOL) implantation']","['mean refraction', 'visual outcomes, refractive outcomes, and adverse events', 'number of eyes with stable or improved VA scores', 'secondary IOL surgery', 'median log MAR VA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]",,0.0801868,"For eyes undergoing IOL implantation after the 4.5 year study visit (n=22), the mean refraction at age 10 ½ years was -3.2 ±2.7D (range -9.9D to 1.1D), compared to -5.5 ±6.6 D (n=53, range -26.5 to 3.0D) in eyes with primary IOL (p=0.03).
","[{'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'VanderVeen', 'Affiliation': ""Department of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston MA.""}, {'ForeName': 'Carolyn D', 'Initials': 'CD', 'LastName': 'Drews-Botsch', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Erick D', 'Initials': 'ED', 'LastName': 'Bothun', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester MN.'}, {'ForeName': 'Lorri B', 'Initials': 'LB', 'LastName': 'Wilson', 'Affiliation': 'Department of Ophthalmology, Casey Eye Institute, Oregon Health & Science University School of Medicine, Portland, OR.'}, {'ForeName': 'M Edward', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'Department of Ophthalmology, Storm Eye Institute, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Lambert', 'Affiliation': 'Department of Ophthalmology, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000412']
2474,32925739,"Adding systematic biopsy to magnetic resonance ultrasound fusion targeted biopsy of the prostate in men with previous negative biopsy or enrolled in active surveillance programs: A prospective single center, randomized study.","Magnetic resonance imaging (MRI) targeted biopsy (TBx) of the prostate demonstrated to improve detection rate (DR) of clinically significant prostate cancer (csPCa) in biopsy-naive patients achieving strong level of evidence. Nevertheless, the csPCa yield for TBx alone versus TBx plus systematic biopsy (SBx) after accounting for overlapping of SBx cores with TBx cores, in prior-negative or active surveillance (AS) patients has not been well established.The objective of the study was to investigate benefits in terms of detection rate and pathological stratification of prostate cancer (PCa) using contextual SBx during MRI-TBx.Patients previously submitted to negative-SBx (cohort A) and those enrolled in an AS program (cohort B) who showed at least 1 suspicious area with a PIRADSv2 score ≥ 3 were prospectively and randomly assigned to only TBx strategy versus TBx plus SBx strategy. SBx locations could not encompass the TBx sites, so that the results of each type of biopsy were independent and did not overlap.A total of 312 patients were included in the 2 cohorts (cohort A: 213 cases; cohort B: 99 cases). No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P = .36) and csPCa-DR (48.2% vs 60.9 respectively; P = .12). The MRI-TBx alone cohort showed higher csPCa/PCa ratio (87.5% vs 62.2%; P = .03). The MRI-TBx plus SBx group subanalysis showed significantly higher csPCa-DR obtained at the MRI-TBx cores when compared with the SBx cores (43.7% vs 24.1%, respectively; P = .01). Independently to age, prostatic-specific antigen and prostate imaging-reporting and data system score, either in rebiopsy (OR 0.43, 0.21-0.97) or AS (OR 0.46, 0.32-0.89) setting, SBx cores were negatively associated with the csPCa-DR when combined to TBx cores.MRI-TBx should be considered the elective method to perform prostate biopsy in patients with previous negative SBx and those considered for an AS program. Adding SBx samples to MRI-TBx did not improve detection rate of csPCa.",2020,No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P = .36) and csPCa-DR (48.2% vs 60.9 respectively; P = .12).,"['men with previous negative biopsy or enrolled in active surveillance programs', 'Patients previously submitted to negative-SBx (cohort A) and those enrolled in an AS program (cohort B) who showed at least 1 suspicious area with a PIRADSv2 score\u200a≥\u200a3', '312 patients were included in the 2 cohorts (cohort A: 213 cases; cohort B: 99 cases']","['magnetic resonance ultrasound fusion targeted biopsy', 'TBx strategy versus TBx plus SBx strategy', 'Magnetic resonance imaging (MRI) targeted biopsy (TBx']","['overall PCa-DR', 'detection rate of csPCa', 'csPCa/PCa ratio', 'csPCa-DR', 'detection rate (DR']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",312.0,0.0363428,No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P = .36) and csPCa-DR (48.2% vs 60.9 respectively; P = .12).,"[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Porreca', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Del Giudice', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Giampaoli', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': ""D'Agostino"", 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Romagnoli', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corsi', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Del Rosso', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Maggi', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, European Institute of Oncology (IEO), Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ferro', 'Affiliation': 'Department of Urology, European Institute of Oncology, IRCCS.'}, {'ForeName': 'Ottavio', 'Initials': 'O', 'LastName': 'de Cobelli', 'Affiliation': 'Department of Urology, European Institute of Oncology, IRCCS.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lucarelli', 'Affiliation': 'Department of Emergency and Organ Transplantation-Urology, Andrology and Kidney Transplantation Unit, University of Bari, Bari.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Schiavina', 'Affiliation': 'Department of Urology, Alma Mater Studiorum Bologna, Policlinico S. Orsola Malpighi, Bologna, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'De Berardinis', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sciarra', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Busetto', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}]",Medicine,['10.1097/MD.0000000000022059']
2475,32925743,Tranexamic acid reduces blood cost in long-segment spinal fusion surgery: A randomized controlled study protocol.,"OBJECTIVE


Long-segment spinal fusion surgery was associated with substantial perioperative blood loss which may increase hospitalization expenses and mortality rates. Substantial studies have reported that tranexamic acid (TXA) could reduce blood products and cost after joint arthroplasty surgery. However, there still exists controversy regarding the efficacy of TXA in long-segment spinal fusion surgery. We performed this protocol to design a randomized controlled study to evaluate the efficacy of TXA in decreasing transfusion rate of allogeneic blood products and transfusion cost in degenerative lumbar scoliosis patients.
METHODS


This study was carried out as a double-blinded, randomized clinical trial on patients with degenerative lumbar scoliosis who prepared for long-segment spinal fusion surgery from December 2018 to December 2019. It was authorized via the Institutional Review Committee in Southwest Medical University (ky2019225). Eighty patients were divided randomly into 2 groups (Experimental group = 40, control group = 40). The patients in the experimental group received 1000 mg of TXA mixed in 100 mL normal saline as a single dose intravenously over 20 minutes before the skin incision was made. Control group received equivalent normal saline without TXA. Primary outcomes included total blood loss, estimated intraoperative blood loss, hematocrit and hemoglobin decline, postoperative drain amount, intra-/postoperative allogeneic transfusion amount and rate, and total transfusion cost. Secondary outcomes included surgical time, thrombotic complications including deep vein thrombosis and pulmonary embolism. All the needed analyses were implemented through utilizing SPSS for Windows Version 20.0.
RESULTS


Table showed the relevant clinical outcomes between experimental group and control group.
CONCLUSION


We hypothesized that TXA was effective and safe in reducing blood transfusion and cost in long-segment spinal fusion surgery.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5854).",2020,Substantial studies have reported that tranexamic acid (TXA) could reduce blood products and cost after joint arthroplasty surgery.,"['long-segment spinal fusion surgery', 'Eighty patients', 'patients with degenerative lumbar scoliosis who prepared for long-segment spinal fusion surgery from December 2018 to December 2019', 'degenerative lumbar scoliosis patients']","['equivalent normal saline without TXA', 'tranexamic acid (TXA', 'TXA mixed in 100 mL normal saline', 'TXA', 'Tranexamic acid']","['blood cost', 'surgical time, thrombotic complications including deep vein thrombosis and pulmonary embolism', 'hospitalization expenses and mortality rates', 'blood transfusion and cost', 'total blood loss, estimated intraoperative blood loss, hematocrit and hemoglobin decline, postoperative drain amount, intra-/postoperative allogeneic transfusion amount and rate, and total transfusion cost']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C2748518', 'cui_str': 'Lumbar scoliosis'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",80.0,0.237383,Substantial studies have reported that tranexamic acid (TXA) could reduce blood products and cost after joint arthroplasty surgery.,"[{'ForeName': 'Linyu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Xufeng', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': ""Department of Orthopedics, the People's Hospital of Jianyang City, Sichuan, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Southwest Medical University.'}]",Medicine,['10.1097/MD.0000000000022069']
2476,32925744,Effects of a multidisciplinary team-led school-based human papillomavirus vaccination health-promotion programme on improving vaccine acceptance and uptake among female adolescents: A cluster randomized controlled trial.,"INTRODUCTION


Evidence has consistently shown the high efficacy of human papillomavirus (HPV) vaccines in preventing cervical cancers. However, the HPV vaccine uptake rate in Hong Kong is very low. We will develop and evaluate an innovative, theory-based multidisciplinary team-led school-based HPV vaccination health-promotion program (MDL-SHPVP), engaging female adolescents, parents/guardians, and secondary school personnel in multicomponent educational strategies and interactive discussions.
METHODS AND ANALYSIS


A cluster randomized controlled trial is proposed. We will recruit 2520 female adolescents and their parents/guardians from 18 secondary day schools. The MDL-SHPVP is underpinned by the Health Belief Model and Precaution Adoption Process Model. Multicomponent interventions will be offered, including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers, and educational computer games. A team of volunteers will be established to raise HPV, cervical cancer, and HPV vaccine awareness. Outcomes include adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs. Data will be collected at baseline, 1 month, and 1 year after intervention. The generalized estimating equations analysis will be used for comparing the outcomes between the 2 groups.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (Ref. no.: 2019.055). We will disseminate the study findings via peer-reviewed publications and presentations at relevant events and international and local conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT04438291.",2020,"Outcomes include adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs.","['2520 female adolescents and their parents/guardians from 18 secondary day schools', 'female adolescents']","['multidisciplinary team-led school-based human papillomavirus vaccination health-promotion programme', 'small group dialogues with a registered nurse and trained healthcare and lay volunteers, and educational computer games', 'human papillomavirus (HPV) vaccines']","[""adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs"", 'HPV vaccine uptake rate', 'vaccine acceptance and uptake']","[{'cui': 'C4517667', 'cui_str': '2520'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",2520.0,0.193298,"Outcomes include adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs.","[{'ForeName': 'Janita Pak Chun', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Suzanne Hoi Shan', 'Initials': 'SHS', 'LastName': 'Lo', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Vivian Wing Yan', 'Initials': 'VWY', 'LastName': 'Lee', 'Affiliation': 'Centre for Learning Enhancement And Research, The Chinese University of Hong Kong.'}, {'ForeName': 'Grace Chung Yan', 'Initials': 'GCY', 'LastName': 'Lui', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Kam Ming', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'Alexander Yuk Lun', 'Initials': 'AYL', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong.'}]",Medicine,['10.1097/MD.0000000000022072']
2477,32925754,The effect of Baduanjin on intestinal flora in patients with prediabetes mellitus: Study protocol for a randomized controlled trial.,"BACKGROUND


The incidence rate of prediabetes is increasing year by year. Prediabetes is a continuous ever fount of diabetes. Diabetes is closely related to intestinal flora imbalance and insulin resistance (IR). Previous studies have proved that Baduanjin can effectively improve the blood glucose and blood lipid of patients, but there is no relevant research on intestinal flora and IR. Therefore, this study focuses on the influence of Baduanjin on intestinal flora of patients with prediabetes, so as to improve the effect of IR, and finally delay or prevent the occurrence of to diabetes mellitus 2 type (T2DM).
METHODS


This study will recruit 80 patients who meet the diagnostic criteria of prediabetes from Hospital of Chengdu University of traditional Chinese Medicine. Eighty patients will be randomly divided into experimental group and control group, 40 cases in each group. The control group received routine lifestyle intervention, and the experimental group received Baduanjin at least 3 to 5 times a week for a total of 6 months. The researchers monitored the intestinal flora, insulin resistance index, blood glucose, blood lipid, body mass index, and other indicators after 3 months of intervention and 6 months of intervention DISCUSSION:: Based on previous studies, intestinal flora is closely related to the occurrence and development of T2DM-IR. Baduanjin can significantly improve the blood glucose and blood lipid of patients with prediabetes, and has a positive effect on the intestinal flora of the elderly and significantly improve the intestinal microecological balance. This study used randomized controlled trial to explore the control method between Baduanjin and conventional lifestyle, in order to further establish the application of Baduanjin in patients with prediabetes.
TRIAL REGISTRATION


This trial protocol has been approved by the research hospital and registered in China clinical trial registration center on July 6, 2020 (ChiCTR2000034490).",2020,"Baduanjin can significantly improve the blood glucose and blood lipid of patients with prediabetes, and has a positive effect on the intestinal flora of the elderly and significantly improve the intestinal microecological balance.","['patients with prediabetes mellitus', 'Eighty patients', 'patients with prediabetes', '80 patients who meet the diagnostic criteria of prediabetes from Hospital of Chengdu University of traditional Chinese Medicine']","['routine lifestyle intervention', 'Baduanjin']","['intestinal microecological balance', 'blood glucose and blood lipid', 'intestinal flora, insulin resistance index, blood glucose, blood lipid, body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",80.0,0.0345877,"Baduanjin can significantly improve the blood glucose and blood lipid of patients with prediabetes, and has a positive effect on the intestinal flora of the elderly and significantly improve the intestinal microecological balance.","[{'ForeName': 'Xiangui', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Maoyi', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu City, Sichuan, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu City, Sichuan, PR China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu City, Sichuan, PR China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yi', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shunqi', 'Initials': 'S', 'LastName': 'Liao', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022108']
2478,32925765,"Influence of Baduanjin on lung function, exercise capacity, and quality of life in patients with mild chronic obstructive pulmonary disease.","INTRODUCTION


Chronic obstructive pulmonary disease (COPD) is an illness characterized by progressive aggravation of airflow limitation, which seriously affects patients' quality of life, and even life-threatening. The lung function of COPD patients is chronically and progressively deteriorated. Among them, the lung function of early COPD patients deteriorates rapidly, and forced expiratory volume in 1 second (FEV1) declines faster than other stages. If diagnosed early and effectively treated in time, it can greatly affect the prognosis. As a traditional exercise regimen, Baduanjin can improve lung function, exercise capacity, and quality of life of COPD patients. However, high-quality evidence-based medical evidence is so far be lacking to confirm the effectiveness of Baduanjin in reducing or preventing mild COPD lung function decline.
METHODS


This study is a randomized controlled trial, 192 patients with mild COPD were randomly divided into experimental group and control group. Both of them will receive basic treatment (health education and Tiotropium bromide), the experimental group will receive Baduanjin exercise training, and the control group will be told to maintain the original lifestyle and control the exercise. The Baduanjin exercise will last for 24 weeks and will be followed up for 72 weeks. The primary outcome is the change in lung function, including FEV1, FEV1/forced vital capacity (FVC), and FEV1/predicted. The secondary results included COPD assessment test, 6-minute walk test, St. George Respiratory Questionnaire, and Dyspnea Scale. Safety will also serve as assessing during the test.
DISCUSSION


The results of this trial will provide that traditional Baduanjin exercises can prevent COPD lung function deterioration, and provide a simple, inexpensive, and daily pulmonary rehabilitation measure for the patients with mild COPD.",2020,"As a traditional exercise regimen, Baduanjin can improve lung function, exercise capacity, and quality of life of COPD patients.","['192 patients with mild COPD', 'patients with mild COPD', 'Chronic obstructive pulmonary disease (COPD', 'patients with mild chronic obstructive pulmonary disease']","['Tiotropium bromide', 'traditional Baduanjin exercises', 'Baduanjin', 'Baduanjin exercise training']","['lung function of early COPD patients deteriorates rapidly, and forced expiratory volume', 'lung function, exercise capacity, and quality of life of COPD patients', 'COPD assessment test, 6-minute walk test, St. George Respiratory Questionnaire, and Dyspnea Scale', 'COPD lung function deterioration', 'lung function', 'change in lung function, including FEV1, FEV1/forced vital capacity (FVC), and FEV1/predicted', 'lung function, exercise capacity, and quality of life']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730604', 'cui_str': 'Mild chronic obstructive pulmonary disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C1306772', 'cui_str': 'tiotropium bromide'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",192.0,0.0380764,"As a traditional exercise regimen, Baduanjin can improve lung function, exercise capacity, and quality of life of COPD patients.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, P.R. China.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Xialing', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Wujun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022134']
2479,32925776,Fascia iliaca compartment block for analgesia in total hip replacement: A randomized controlled study protocol.,"BACKGROUND


Pain management after the total joint arthroplasty is still challenging, but worthy of attention, because good pain management can improve the outcomes of patient. It is still controversial whether fascia iliaca compartment block (FICB) can effectively decrease the opioid consumption and pain after total hip replacement (THR) owing to the number of published investigations is small. The purpose of this present study is to assess the efficacy and safety of FICB for postoperative analgesia after THR.
METHODS


This is a single center, placebo-controlled randomized trial which is performed in accordance with the SPIRIT Checklist for randomized studies. It was authorized via the Chifeng Municipal Hospital institutional review committee (H2020-19-8). 100 patients undergoing THR will be included in this study. Patients are randomly divided into 2 groups: FICB group or Non-FICB group, FICB with 5mgmL of epinephrine and 40 mL of ropivacaine 0.2%. Primary outcomes are pain score at different time point. Visual analog scale is used to assess the pain (10: the maximum possible pain and 0: absent pain). The secondary outcomes are the postoperative complications, length of hospital stay and total consumption of opioid. All the needed analyses are implemented through utilizing SPSS for Windows Version 15.0.
RESULTS


Figure 1 will show the primary and secondary outcomes.
CONCLUSION


This trial can provide an evidence for the use of FICB for analgesia after THR.",2020,It is still controversial whether fascia iliaca compartment block (FICB) can effectively decrease the opioid consumption and pain after total hip replacement (THR) owing to the number of published investigations is small.,"['100 patients undergoing THR', 'total hip replacement']","['placebo', 'FICB', 'FICB group or Non-FICB group, FICB with 5mgmL of epinephrine and 40\u200amL of ropivacaine', 'Fascia iliaca compartment block for analgesia']","['efficacy and safety', 'pain score', 'Visual analog scale', 'postoperative complications, length of hospital stay and total consumption of opioid']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",100.0,0.111232,It is still controversial whether fascia iliaca compartment block (FICB) can effectively decrease the opioid consumption and pain after total hip replacement (THR) owing to the number of published investigations is small.,"[{'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Department of neurology, Chifeng Municipal Hospital, Inner Mongolia, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Xizhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology.'}]",Medicine,['10.1097/MD.0000000000022158']
2480,32925778,Study on metabonomics of Chinese herbal medicine in the treatment of type 2 diabetes mellitus complicated with community-acquired pneumonia.,"INTRODUCTION


Community-acquired pneumonia (CAP) is the main acute complication of type 2 diabetes mellitus (T2DM) and the main cause of hospitalization for infectious diseases. Unfortunately, in the treatment of type 2 diabetes mellitus complicated with community-acquired pneumonia (T2DM-CAP), modern medicine is still faced with enormous challenges because of insulin resistance and drug-resistant bacteria. In recent decades, clinical and experimental evidence shows that Chinese herbal medicine (CHM) has a certain beneficial effect on diabetes and pneumonia. Therefore, this trial aims to assess the efficacy and safety of CHM plus western medicines for the treatment of T2DM-CAP.
METHODS


We propose a double-blind, placebo-controlled, randomized superiority trial.A total of 92 participants with T2DM-CAP will be randomly allocated at a 1:1 ratio to either the experimental group, which will receive modified Ban-Xia-Xie-Xin-Decotion and basic treatment, or the control group, which will receive basic treatment only. The study duration will be 14 days. The primary outcome will be the total clinical effective rate. The secondary outcomes are traditional Chinese medicine symptom score scale, pneumonia severity index, usage time of antibiotic, time required for blood sugar to reach the required level, frequency of hypoglycemia, and chest CT. Liquid chromatograph-mass spectrometry method will be used to explore the blood metabolism profiles of the subjects, to explore the pathogenesis of T2DM-CAP and the mechanism of CHM on T2DM-CAP. Adverse events will also be evaluated.
DISCUSSION


This trial will provide evidence of the effectiveness and safety of traditional CHM in treating patients with T2DM-CAP.
TRIAL REGISTRATION NUMBER


ChiCTR2000035204.",2020,"This trial will provide evidence of the effectiveness and safety of traditional CHM in treating patients with T2DM-CAP.
","['patients with T2DM-CAP', '92 participants with T2DM-CAP', 'type 2 diabetes mellitus complicated with community-acquired pneumonia']","['modified Ban-Xia-Xie-Xin-Decotion and basic treatment, or the control group', 'Chinese herbal medicine (CHM', 'CHM plus western medicines', 'placebo', 'traditional CHM', 'Chinese herbal medicine']","['traditional Chinese medicine symptom score scale, pneumonia severity index, usage time of antibiotic, time required for blood sugar to reach the required level, frequency of hypoglycemia, and chest CT', 'efficacy and safety', 'Adverse events', 'total clinical effective rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0950099', 'cui_str': 'Ban Xia'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1321595', 'cui_str': 'Pneumonia severity index'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",92.0,0.186967,"This trial will provide evidence of the effectiveness and safety of traditional CHM in treating patients with T2DM-CAP.
","[{'ForeName': 'Hongjing', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Rensong', 'Initials': 'R', 'LastName': 'Yue', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Lizhen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Long', 'Affiliation': 'Chengdu Qingbaijiang District Traditional Chinese Medicine Hospital, Chengdu, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022160']
2481,32928599,Using Yoga to Reduce Anxiety in Children: Exploring School-Based Yoga Among Rural Third- and Fourth-Grade Students.,"INTRODUCTION


Anxiety is becoming more common in children and can negatively affect social and academic performance. The purpose of this study was to explore the impact of 10 min of yoga on anxiety in third- and fourth-graders over 8 weeks.
METHOD


Participants completed 10 min of yoga daily during the school week. Participants completed the Screen for Child Anxiety Related Emotional Disorders anxiety screening tool at the beginning and after the program.
RESULTS


Paired sample t test noted a significant difference between pretest and posttest raw scores in the category of generalized anxiety disorder. On average, participants had significantly decreased raw anxiety scores after completing the program (mean = -0.0308), t (60)  = -3.137, p < .05.
DISCUSSION


This study demonstrates that yoga practiced as little as 10 min a day over 8 weeks can have a significant impact on decreasing anxiety in children aged 8-10 years.",2020,"On average, participants had significantly decreased raw anxiety scores after completing the program (mean = -0.0308), t (60)  ","['children aged 8-10 years', 'Exploring School-Based Yoga Among Rural Third- and Fourth-Grade Students', 'Participants completed 10 min of yoga daily during the school week', 'Children']",[],"['raw anxiety scores', 'anxiety', 'Child Anxiety Related Emotional Disorders anxiety screening tool']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],"[{'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",,0.0478108,"On average, participants had significantly decreased raw anxiety scores after completing the program (mean = -0.0308), t (60)  ","[{'ForeName': 'Marilou', 'Initials': 'M', 'LastName': 'Shreve', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Charleen', 'Initials': 'C', 'LastName': 'McNeill', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Washburn', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.07.008']
2482,32928601,Youth and Parent Health-Related Quality of Life and Association With Glycemic Outcomes in Preadolescents and Adolescents With Type 1 Diabetes.,"INTRODUCTION


We explored differences in Health-Related Quality of Life (HRQOL) and the youth's glycosylated hemoglobin (A1c) of preadolescent and adolescent youths with type 1 diabetes (T1D) by individual (age, sex, race) and family (socioeconomic status) factors, and associations between youths' HRQOL, their parents' HRQOL, and youth's A1c.
METHOD


Correlational secondary analysis of baseline data from a randomized controlled trial testing a developmental intervention for youths with T1D and their parents from two diabetes clinics.
RESULTS


Better adolescent HRQOL was associated with better glycemic control. Better preadolescent HRQOL was associated with better parent HRQOL. Non-White adolescents had worse HRQOL than White adolescents; whereas Non-White preadolescents had worse glycemic control than White preadolescents.
DISCUSSION


Addressing HRQOL may promote better glycemic control in adolescents with T1D. For preadolescents with T1D, parent HRQOL support may impact preadolescent HRQOL and improve glycemic control moving into adolescence. Further study is warranted for non-White youths with T1D HRQOL and A1c outcomes.",2020,"White adolescents had worse HRQOL than White adolescents; whereas Non-White preadolescents had worse glycemic control than White preadolescents.
","[""preadolescent and adolescent youths with type 1 diabetes (T1D) by individual (age, sex, race) and family (socioeconomic status) factors, and associations between youths' HRQOL, their parents' HRQOL, and youth's A1c"", 'youths with T1D and their parents from two diabetes clinics', 'Preadolescents and Adolescents With Type 1 Diabetes', 'adolescents with T1D. For preadolescents with T1D']",['developmental intervention'],"['Health-Related Quality of Life (HRQOL', 'glycemic control']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0477706,"White adolescents had worse HRQOL than White adolescents; whereas Non-White preadolescents had worse glycemic control than White preadolescents.
","[{'ForeName': 'Joan P', 'Initials': 'JP', 'LastName': 'Totka', 'Affiliation': ''}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Snethen', 'Affiliation': ''}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Cox', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.07.015']
2483,32928607,Establishment and validation of a model for brain injury state evaluation and prognosis prediction.,"PURPOSE


Traumatic brain injury (TBI) is one of the leading causes of disability and death in modern times, whose evaluation and prognosis prediction have been one of the most critical issues in TBI management. However, the existed models for the abovementioned purposes were defective to varying degrees. This study aims to establish an ideal brain injury state clinical prediction model (BISCPM).
METHODS


This study was a retrospective design. The six-month outcomes of patients were selected as the end point event. BISCPM was established by using the split-sample technology, and externally validated via different tests of comparison between the observed and predicted six-month mortality in validating group. TBI patients admitted from July 2006 to June 2012 were recruited and randomly divided into establishing model group and validating model group. 21 scoring indicators were included in BISCPM and divided into three parts, A, B, and C. Part A included movement, pupillary reflex and diameter, CT parameters, and secondary brain insult factors, etc. Part B was age and part C was medical history of the patients. The total score of part A, B and C was final score of BISCPM.
RESULTS


Altogether 1156 TBI patients were included with 578 cases in each group. The score of BISCPM from validating group ranged from 2.75 to 31.94, averaging 13.64 ± 5.59. There was not statistical difference between observed and predicted mortality for validating group. The discrimination validation showed that the BISCPM is superior to international mission for prognosis and analysis of clinical trials (IMPACT) lab model.
CONCLUSION


BISCPM is an effective model for state evaluation and prognosis prediction of TBI patients. The use of BISCPM could be of great significance for decision-making in management of TBI.",2020,"The discrimination validation showed that the BISCPM is superior to international mission for prognosis and analysis of clinical trials (IMPACT) lab model.
","['TBI patients', 'Altogether 1156 TBI patients were included with 578 cases in each group', 'TBI patients admitted from July 2006 to June 2012', 'Traumatic brain injury (TBI']",['BISCPM'],"['score of BISCPM', 'total score of part A, B and C']","[{'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1156.0,0.0227368,"The discrimination validation showed that the BISCPM is superior to international mission for prognosis and analysis of clinical trials (IMPACT) lab model.
","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lü', 'Affiliation': ""Neurosurgical Institute of PLA, Xi'an 710032, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Digestive Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': ""Department of Statistics, School of Preventive Medicine, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Shu-Hui', 'Initials': 'SH', 'LastName': 'Dai', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Xue-An', 'Initials': 'XA', 'LastName': 'Hu', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Xiao-Fan', 'Initials': 'XF', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Fei', 'Affiliation': ""Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China. Electronic address: xjswlixia@sina.com.""}]",Chinese journal of traumatology = Zhonghua chuang shang za zhi,['10.1016/j.cjtee.2020.08.006']
2484,32928616,Hostility and aggressive behaviour in first episode psychosis: Results from the OPTiMiSE trial.,"AIM


The aim of this paper is to determine clinical factors related to hostility and disturbing and aggressive behaviour and to examine the effect of medication on these behaviours in FEP.
METHODS


Data from phase I and II of the OPTiMiSE trial are used. Outcome measures are the hostility item of the Positive and Negative Syndrome Scale (PANSS P7) and the disturbing and aggressive behaviour domain of the Personal and Social Performance scale (PSP-D).
RESULTS


Moderate, severe or extreme hostility (PANSS P7 > 3) was present in 42 patients (9.4%). The PANSS P7 and PSP-D were low to moderate but significantly associated with the selected PANSS items: delusions, hallucinatory behaviour, excitement, tension, uncooperativeness, unusual thought content, impulsivity, and lack of judgement and insight. In a subsample of 185 patients (41.5%) with baseline PANSS P7 > 1, the PANSS P7 and PSP-D scores improved in the first 4 weeks of amisulpride treatment. This effect remained significant after controlling for baseline positive symptoms (PANSS P1-P6). No significant differences were found between olanzapine and amisulpride in the second phase of the trial.
CONCLUSION


Clinical risk factors such as poor impulse control, uncooperativeness and excitement could help clinicians in detecting and treating hostile and aggressive behaviour in FEP. Amisulpride could be an effective antipsychotic choice in the treatment of FEP patients who express hostile or aggressive behaviour. Future research is needed to compare the effects of amisulpride and olanzapine on hostility in FEP during the first weeks of treatment.",2020,"No significant differences were found between olanzapine and amisulpride in the second phase of the trial.
","['first episode psychosis', 'FEP patients who express hostile or aggressive behaviour']","['amisulpride', 'olanzapine', 'Amisulpride', 'amisulpride and olanzapine']","['PANSS P7 and PSP-D', 'PANSS P7 and PSP-D scores', 'Hostility and aggressive behaviour', 'severe or extreme hostility', 'hostility item of the Positive and Negative Syndrome Scale (PANSS P7) and the disturbing and aggressive behaviour domain of the Personal and Social Performance scale (PSP-D']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",185.0,0.0216339,"No significant differences were found between olanzapine and amisulpride in the second phase of the trial.
","[{'ForeName': 'Margo D M', 'Initials': 'MDM', 'LastName': 'Faay', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: m.d.m.faay@umcutrecht.nl.'}, {'ForeName': 'G Caroline M', 'Initials': 'GCM', 'LastName': 'van Baal', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Arango', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Covadonga M', 'Initials': 'CM', 'LastName': 'Díaz-Caneja', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Berger', 'Affiliation': 'University Hospital of Psychiatry Zurich, Department of Child and Adolescent Psychiatry and Psychotherapy, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Bobes', 'Affiliation': 'Department of Medicine-Psychiatry, University of Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), INEUROPA, CIBERSAM, Oviedo, Spain.'}, {'ForeName': 'Pilar A', 'Initials': 'PA', 'LastName': 'Sáiz', 'Affiliation': 'Department of Medicine-Psychiatry, University of Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), INEUROPA, CIBERSAM, Oviedo, Spain.'}, {'ForeName': 'María Paz', 'Initials': 'MP', 'LastName': 'García-Portilla', 'Affiliation': 'Department of Medicine-Psychiatry, University of Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), INEUROPA, CIBERSAM, Oviedo, Spain.'}, {'ForeName': 'Resy', 'Initials': 'R', 'LastName': 'van de Brug', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Petter', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Winter-van Rossum', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Department of Neuroscience, University Medical Center Groningen, Deusinglaan 2, Groningen, the Netherlands; Department of Medical and Biological Psychology, University of Bergen, Norway.'}]",Schizophrenia research,['10.1016/j.schres.2020.08.021']
2485,32928659,Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix.,"BACKGROUND


Dyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL).
AIM


We evaluated the relationship of clinically meaningful improvements in dyspareunia with HRQoL changes among women with endometriosis.
METHODS


This was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials. Women aged 18-49 years with moderate to severe endometriosis-associated pain were randomized to placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain. Dyspareunia was ranked 0-3 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly. A woman with a clinically meaningful dyspareunia response (dyspareunia responder) was defined as a woman with a reduction from the baseline in dyspareunia score greater than or equal to a predetermined cutoff while maintaining stable/decreased analgesic use.
OUTCOMES


Dyspareunia response impact on EHP-30 scores was determined at 3 and 6 months using multivariate linear regression controlling for age, baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity.
RESULTS


Analysis included 1,368 women with a mean age of 32.2 years. Dyspareunia responders had significant improvements vs non-responders in all adjusted mean EHP-30 domain scores at months 3 and 6 (control and powerlessness: -17.8 and -18.5; emotional well-being: -10.0 and -10.4; pain: -15.3 and -15.7; self-image: -11.4 and -12.8; social support: -14.3 and -14.0; and sexual intercourse: -18.1 and -19.7; all P < .0001).
CLINICAL IMPLICATIONS


Dyspareunia improvements are associated with both personal and psychological benefits.
STRENGTHS & LIMITATIONS


This study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results. As such, the findings may not be generalizable in a real-world setting. Although the perception of dyspareunia and its severity and the associated effect on HRQoL was subjective, the use of a large patient sample was used to minimize potential issues with this limitation.
CONCLUSION


Clinically meaningful responses in dyspareunia are associated with improvements across multiple HRQoL domains among women with endometriosis. Agarwal SK, Soliman AM, Pokrzywinski RM, et al. Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix. J Sex Med 2020;XX:XXX-XXX.",2020,Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain,"['large sample of women from a well-defined patient population', '1,368 women with a mean age of 32.2\xa0years', 'Associated with Endometriosis', 'Women aged 18-49 years with moderate to severe endometriosis-associated pain', 'A woman with a clinically meaningful dyspareunia response (dyspareunia responder', 'Endometriosis', 'Women with Moderate to Severe Pain', 'women diagnosed with endometriosis', 'Women', 'women with endometriosis']","['placebo, elagolix 150\xa0mg once daily, or elagolix 200\xa0mg twice daily']","['dyspareunia with HRQoL changes', 'dyspareunia score', 'Dyspareunia', 'HRQoL', 'Health-Related Quality of Life', 'Severe Pain', 'Dyspareunia response impact on EHP-30 scores', 'baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity', 'Dyspareunia responders', 'mean EHP-30 domain scores']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442825', 'cui_str': 'Well defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704593', 'cui_str': 'elagolix 150 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",1368.0,0.13689,Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain,"[{'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Agarwal', 'Affiliation': 'Center for Endometriosis Research and Treatment, University of California, San Diego, La Jolla, CA, USA. Electronic address: skagarwal@health.ucsd.edu.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'Health Economics and Outcomes Research, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'Global Pharmaceutical Research and Development, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.08.002']
2486,32928709,"Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering in the ODYSSEY CHOICE I trial.","BACKGROUND


The ODYSSEY CHOICE I study (NCT01926782) evaluated alirocumab 300 mg every 4 weeks (Q4W) in patients with hypercholesterolemia receiving maximally tolerated statin or no statin.
OBJECTIVE


The objective of the study was to assess the relationship between alirocumab, proprotein convertase subtilisin/kexin type 9 (PCSK9), and low-density lipoprotein cholesterol (LDL-C) concentrations with the CHOICE I alirocumab dosing regimen.
METHODS


This analysis included 803 patients (547 statin-treated, 256 without statin) who were randomized to alirocumab 300 mg Q4W, alirocumab 75 mg every 2 weeks (Q2W), or placebo. 300 mg Q4W and 75 mg Q2W doses were adjusted to 150 mg Q2W at Week 12 if Week 8 LDL-C was >70 or >100 mg/dL, depending on cardiovascular risk, or if LDL-C reduction was <30% from baseline.
RESULTS


Most patients remained on 300 mg Q4W without dose adjustment as they achieved study-defined LDL-C goals at Week 8 (statin-treated: 80.7%; no statin: 85.3%). LDL-C was reduced by 60.5%-71.9% over Weeks 20-24 in patients on 300 mg Q4W and 57.2%-63.0% in patients with dose adjustment from 300 mg Q4W to 150 mg Q2W. Statin-treated patients had higher cardiovascular risk as well as higher free PCSK9 and lower alirocumab concentrations (vs no statin), suggesting increased target-mediated clearance. Regardless of statin status, the most common adverse events in alirocumab-treated patients were injection-site reaction and headache.
CONCLUSIONS


Data provide further insight on alirocumab's mode of action in terms of relationship between alirocumab, PCSK9, and LDL-C, and disease severity, and support the use of alirocumab 300 mg Q4W as an efficacious dosing regimen for clinically meaningful LDL-C reductions.",2020,"LDL-C was reduced by 60.5%-71.9% over Weeks 20-24 in patients on 300 mg Q4W and 57.2%-63.0% in patients with dose adjustment from 300 mg Q4W to 150 mg Q2W. Statin-treated patients had higher cardiovascular risk as well as higher free PCSK9 and lower alirocumab concentrations (vs no statin), suggesting increased target-mediated clearance.","['patients with hypercholesterolemia receiving maximally tolerated statin or no statin', '803 patients (547 statin-treated, 256 without statin']","['alirocumab', 'alirocumab 300\xa0mg Q4W, alirocumab 75\xa0mg every 2\xa0weeks (Q2W), or placebo']","['low-density lipoprotein cholesterol (LDL-C) concentrations', 'cardiovascular risk', 'free PCSK9 and lower alirocumab concentrations', 'target-mediated clearance', 'LDL-C', 'Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",803.0,0.168661,"LDL-C was reduced by 60.5%-71.9% over Weeks 20-24 in patients on 300 mg Q4W and 57.2%-63.0% in patients with dose adjustment from 300 mg Q4W to 150 mg Q2W. Statin-treated patients had higher cardiovascular risk as well as higher free PCSK9 and lower alirocumab concentrations (vs no statin), suggesting increased target-mediated clearance.","[{'ForeName': 'Eli M', 'Initials': 'EM', 'LastName': 'Roth', 'Affiliation': 'The Sterling Research Group, Cincinnati, OH, USA. Electronic address: eroth@sterlingresearch.org.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': 'Harvard Clinical Research Institute, Boston, MA, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Farnier', 'Affiliation': 'Lipid Clinic, Point Médical and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'McKenney', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'A Thomas', 'Initials': 'AT', 'LastName': 'DiCioccio', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Brunet', 'Affiliation': 'Sanofi, Clinical Development, R&D, Montpellier, France.'}, {'ForeName': 'Garen', 'Initials': 'G', 'LastName': 'Manvelian', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sasiela', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi, Clinical Development, R&D, Montpellier, France.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Robinson', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2020.07.009']
2487,32928717,A randomized controlled trial to compare the safety and efficacy of sirolimus-eluting biodegradable polymer ultra-thin stent (SUPRAFLEX Cruz) and everolimus-eluting biodegradable polymer stent (SYNERGY) in treatment for three-vessel coronary artery disease: design of the Multivessel TALENT trial.,"AIMS


The purpose of the Multivessel TALENT trial is to compare clinical outcomes of novel SUPRAFLEX Cruz stent with those of SYNERGY stent in patients with three vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI).
METHODS AND RESULTS


In this prospective, randomized, 1:1 balanced, multi-center, open-label trial, 1550 patients with de novo 3VD without left main disease are assigned to the SUPRAFLEX Cruz or SYNERGY arm. The following treatment principles of the ""best practice"" PCI will be applied: Heart Team consensus based on SYNTAX Score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimization by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularization, at 12 months post-procedure. The powered secondary endpoint is a superiority comparison of vessel-oriented composite endpoint (VOCE) defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically-indicated-target vessel revascularization, at 24 months.
CONCLUSIONS


The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin SUPRAFLEX Cruz stents, compared with the SYNERGY stents.",2020,"The powered secondary endpoint is a superiority comparison of vessel-oriented composite endpoint (VOCE) defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically-indicated-target vessel revascularization, at 24 months.
","['three-vessel coronary artery disease', 'patients with three vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI', '1550 patients with de novo 3VD without left main disease are assigned to the SUPRAFLEX Cruz or SYNERGY arm']","['sirolimus-eluting biodegradable polymer ultra-thin stent (SUPRAFLEX Cruz) and everolimus-eluting biodegradable polymer stent (SYNERGY', 'novel SUPRAFLEX Cruz stent']","['safety and efficacy', 'superiority comparison of vessel-oriented composite endpoint (VOCE) defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically-indicated-target vessel revascularization', 'non-inferiority comparison of patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularization']","[{'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",1550.0,0.120677,"The powered secondary endpoint is a superiority comparison of vessel-oriented composite endpoint (VOCE) defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically-indicated-target vessel revascularization, at 24 months.
","[{'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': ''}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': ''}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': ''}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Marie-Angèle', 'Initials': 'MA', 'LastName': 'Morel', 'Affiliation': ''}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': ""O'Leary"", 'Affiliation': ''}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': ''}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Möllmann', 'Affiliation': ''}, {'ForeName': 'Johan H C', 'Initials': 'JHC', 'LastName': 'Reiber', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ''}, {'ForeName': 'Azfar', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': ''}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00772']
2488,32928732,Mutations identified in the HCV polymerase of ribavirin treated chronic hepatitis C patients cause resistance and affect viral replication fidelity.,"Ribavirin has been used to treat patients with chronic hepatitis C virus (HCV) infection for 25 years, however, its antiviral mechanism of action remains unclear. Here we studied virus evolution in a subset of samples from a randomized 24-week trial of ribavirin monotherapy versus placebo in chronic HCV patients, as well as the viral resistance mechanisms of the observed ribavirin-associated mutations in cell-culture. Thus, we performed next generation sequencing of the full-length coding sequences of HCV recovered from patients at weeks 0, 12, 20, 32 and 40 and analyzed novel single nucleotide polymorphisms (SNPs), diversity, and mutation-linkage. At week 20, increased genetic diversity was observed in 5 ribavirin- compared to 4 placebo-treated HCV patients due to new synonymous SNPs, particularly G-to-A and C-to-U ribavirin-associated transitions. Moreover, emergence of 14 non-synonymous SNPs in HCV nonstructural 5B (NS5B) occurred in treated patients, but not in placebo controls. Most substitutions located close to the NS5B polymerase nucleotide entry site. Linkage analysis showed that putative resistance mutations were found in the majority of genomes in ribavirin-treated patients. Identified NS5B mutations from genotype 3a patients were further introduced into the genotype 3a cell-culture adapted DBN strain for studies in Huh7.5 cells. Specific NS5B substitutions, including DBN-D148N+I363V, DBN-A150V+I363V, and DBN-T227S+S183P, conferred resistance to ribavirin in long-term cell-culture treatment, possibly by reducing the HCV polymerase error rate. In conclusion, prolonged exposure of HCV to ribavirin in chronic hepatitis C patients induces NS5B resistance mutations leading to increased polymerase fidelity, which could be one mechanism for ribavirin resistance.",2020,"At week 20, increased genetic diversity was observed in 5 ribavirin- compared to 4 placebo-treated HCV patients due to new synonymous SNPs, particularly G-to-A and C-to-U ribavirin-associated transitions.","['chronic HCV patients', 'patients with chronic hepatitis C virus (HCV) infection for 25 years', 'chronic hepatitis C patients']","['ribavirin', 'Ribavirin', 'placebo', 'ribavirin monotherapy versus placebo']","['HCV nonstructural 5B (NS5B', 'genetic diversity', 'putative resistance mutations']","[{'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.0174769,"At week 20, increased genetic diversity was observed in 5 ribavirin- compared to 4 placebo-treated HCV patients due to new synonymous SNPs, particularly G-to-A and C-to-U ribavirin-associated transitions.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Mejer', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Fahnøe', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Galli', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Santseharay', 'Initials': 'S', 'LastName': 'Ramirez', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Weiland', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Dermatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Hvidovre Hospital, Hvidovre, Denmark. Thomas.Lars.Benfield@regionh.dk jbukh@sund.ku.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bukh', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark Thomas.Lars.Benfield@regionh.dk jbukh@sund.ku.dk.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01417-20']
2489,32928788,Effect of CPAP on cardiovascular events in minimally symptomatic OSA: long-term follow-up of the MOSAIC randomised controlled trial.,"The effect of continuous positive airway pressure (CPAP) on cardiovascular events is uncertain in minimally symptomatic obstructive sleep apnoea. Previous 2-year follow-up data from the Multicentre Obstructive Sleep Apnoea Intervention Cardiovascular (MOSAIC) trial showed a marginal reduction in cardiovascular events with CPAP therapy. We now present long-term MOSAIC study follow-up data. Median (first quartile, third quartile) follow-up was 5.0 (2.2, 5.0) and 3.7 (1.5, 5.0) years for CPAP and standard care, respectively. Compared to standard care, CPAP had no statistically significant effect on the risk of cardiovascular events (HR=0.83, p=0.54, 95% CI 0.46-1.51).",2020,"Compared to standard care, CPAP had no statistically significant effect on the risk of cardiovascular events (HR=0.83, p=0.54, 95% CI 0.46-1.51).","['minimally symptomatic OSA', 'minimally symptomatic obstructive sleep apnoea']","['CPAP', 'continuous positive airway pressure (CPAP', 'CPAP therapy']","['risk of cardiovascular events', 'cardiovascular events']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0619029,"Compared to standard care, CPAP had no statistically significant effect on the risk of cardiovascular events (HR=0.83, p=0.54, 95% CI 0.46-1.51).","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Tang', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Milton Keynes University Hospital, Milton Keynes, UK.'}, {'ForeName': 'Chris D', 'Initials': 'CD', 'LastName': 'Turnbull', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK christopher.turnbull@ouh.nhs.uk.'}, {'ForeName': 'Dushendree', 'Initials': 'D', 'LastName': 'Sen', 'Affiliation': 'Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Liverpool Sleep and Ventilation Centre, University Hospital Aintree, Liverpool, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Centre for Interdisciplinary Sleep Research, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Stradling', 'Affiliation': 'NIHR Biomedical Research Centre Oxford, University of Oxford, Oxford, Oxfordshire, UK.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000742']
2490,32929215,Ketamine modulates fronto-striatal circuitry in depressed and healthy individuals.,"Ketamine improves motivation-related symptoms in depression but simultaneously elicits similar symptoms in healthy individuals, suggesting that it might have different effects in health and disease. This study examined whether ketamine affects the brain's fronto-striatal system, which is known to drive motivational behavior. The study also assessed whether inflammatory mechanisms-which are known to influence neural and behavioral motivational processes-might underlie some of these changes. These questions were explored in the context of a double-blind, placebo-controlled, crossover trial of ketamine in 33 individuals with treatment-resistant major depressive disorder (TRD) and 25 healthy volunteers (HVs). Resting-state functional magnetic resonance imaging (rsfMRI) was acquired 2 days post-ketamine (final sample: TRD n = 27, HV n = 19) and post-placebo (final sample: TRD n = 25, HV n = 18) infusions and was used to probe fronto-striatal circuitry with striatal seed-based functional connectivity. Ketamine increased fronto-striatal functional connectivity in TRD participants toward levels observed in HVs while shifting the connectivity profile in HVs toward a state similar to TRD participants under placebo. Preliminary findings suggest that these effects were largely observed in the absence of inflammatory (C-reactive protein) changes and were associated with both acute and sustained improvements in symptoms in the TRD group. Ketamine thus normalized fronto-striatal connectivity in TRD participants but disrupted it in HVs independently of inflammatory processes. These findings highlight the potential importance of reward circuitry in ketamine's mechanism of action, which may be particularly relevant for understanding ketamine-induced shifts in motivational symptoms.",2020,Ketamine increased fronto-striatal functional connectivity in TRD participants toward levels observed in HVs while shifting the connectivity profile in HVs toward a state similar to TRD participants under placebo.,"['33 individuals with treatment-resistant major depressive disorder (TRD) and 25 healthy volunteers (HVs', 'TRD participants', 'depressed and healthy individuals', 'healthy individuals']","['Resting-state functional magnetic resonance imaging (rsfMRI', 'Ketamine', 'placebo (final sample: TRD n\u2009=\u200925, HV n\u2009=\u200918) infusions and was used to probe fronto-striatal circuitry with striatal seed-based functional connectivity', 'ketamine', 'placebo']",['fronto-striatal functional connectivity'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",33.0,0.119014,Ketamine increased fronto-striatal functional connectivity in TRD participants toward levels observed in HVs while shifting the connectivity profile in HVs toward a state similar to TRD participants under placebo.,"[{'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. anahit.mkrtchian@nih.gov.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': 'Neuroscience and Mental Health Group, Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Molecular psychiatry,['10.1038/s41380-020-00878-1']
2491,32929540,Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307).,"PURPOSE


Bisphosphonates reduce bone metastases in postmenopausal women with early-stage breast cancer but carry the risk of bisphosphonate-related osteonecrosis of the jaw (BRONJ). We describe risk factors for BRONJ and compare BRONJ provoked by infection or trauma with spontaneous lesions, which carry a better prognosis.
METHODS


SWOG 0307 randomized women with stage I-III breast cancer to receive zoledronic acid (ZA), clodronate (CL), or ibandronate (IB) for 3 years, implemented BRONJ prevention guidelines, and collected information about dental health and development of BRONJ. All statistical tests were two-sided.
RESULTS


Of 6018 women, 48 developed BRONJ. Infection was present in 21 (43.8%). Median time to BRONJ was 2.1 years for ZA, 2.0 years for IB, and 3.4 years for clodronate (p = 0.04). BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05). Of 57 lesions, BRONJ occurred spontaneously in 20 (35.1%) and was provoked by dental extraction in 20 (35.1%), periodontal disease in 14 (24.6%), denture trauma in 6 (10.5%), and dental surgery in 2 (3.5%). Spontaneous BRONJ occurred more frequently at the mylohyoid ridge. There were no differences in dental disease, infection, or bisphosphonate type between spontaneous and provoked BRONJ.
CONCLUSION


ZA and worse dental health were associated with increased incidence of BRONJ, with a trend toward additive risk when combined. BRONJ incidence was lower than in similar studies, with prevention strategies likely linked to this.
CLINICAL TRIAL NUMBER


NCT00127205 REGISTRATION DATE: July 2005.",2020,"BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05).","['SWOG 0307 randomized women with stage I-III breast cancer to receive', '6018 women, 48 developed BRONJ', 'early-stage breast cancer (SWOG 0307', 'postmenopausal women with early-stage breast cancer']","['zoledronic acid (ZA), clodronate (CL), or ibandronate (IB', 'Bisphosphonates', 'clodronate', 'bisphosphonate', 'adjuvant bisphosphonates']","['Median time to BRONJ', 'gingivitis', 'dental disease, infection, or bisphosphonate type between spontaneous and provoked BRONJ', 'dental calculus', 'Infection', 'moderate/severe periodontal disease', 'denture trauma', 'periodontal disease']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3178777', 'cui_str': 'Osteonecrosis of jaw due to bisphosphonate'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3178777', 'cui_str': 'Osteonecrosis of jaw due to bisphosphonate'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}, {'cui': 'C1704330', 'cui_str': 'Disorder of teeth AND/OR supporting structures'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0011330', 'cui_str': 'Dental calculus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",6018.0,0.0975579,"BRONJ was associated with bisphosphonate type (28/2231 (1.26%) for ZA, 8/2235 (0.36%) for CL, 12/1552 (0.77%) for IB), dental calculus (OR 2.03), gingivitis (OR 2.11), moderate/severe periodontal disease (OR 2.87), and periodontitis > 4 mm (OR 2.20) (p < 0.05).","[{'ForeName': 'Darya A', 'Initials': 'DA', 'LastName': 'Kizub', 'Affiliation': 'The Everett Clinic, Everett, WA, USA. daryakizub@gmail.com.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Schubert', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alexander H G', 'Initials': 'AHG', 'LastName': 'Paterson', 'Affiliation': 'Tom Baker Cancer Center, Calgary, Alberta, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carla I', 'Initials': 'CI', 'LastName': 'Falkson', 'Affiliation': 'Wilmot Cancer Center at the University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'SWOG Statistical Center, Seattle, WA, USA.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05748-8']
2492,32929612,Mechanism-based modeling of the effect of a novel inhibitor of vascular adhesion protein-1 on albuminuria and renal function markers in patients with diabetic kidney disease.,"The vascular adhesion protein-1 (VAP-1) inhibitor ASP8232 reduces albuminuria in patients with type 2 diabetes and chronic kidney disease. A mechanism-based model was developed to quantify the effects of ASP8232 on renal markers from a placebo-controlled Phase 2 study in diabetic kidney disease with 12 weeks of ASP8232 treatment. The model incorporated the available pharmacokinetic, pharmacodynamic (plasma VAP-1 concentration and activity), serum and urine creatinine, serum cystatin C, albumin excretion rate, urinary albumin-to-creatinine ratio, and urine volume information in an integrated manner. Drug-independent time-varying changes and different drug effects could be quantified for these markers using the model. Through simulations, this model provided the opportunity to dissect the relationship and longitudinal association between the estimated glomerular filtration rate and albuminuria and to quantify the pharmacological effects of ASP8232. The developed drug-independent model may be useful as a starting point for other compounds affecting the same biomarkers in a similar time scale.",2020,The vascular adhesion protein-1,"['patients with type 2 diabetes and chronic kidney disease', 'patients with diabetic kidney disease', 'diabetic kidney disease with 12\xa0weeks of ASP8232 treatment']","['ASP8232', 'novel inhibitor of vascular adhesion protein-1', 'VAP-1) inhibitor']","['albuminuria and renal function markers', 'available pharmacokinetic, pharmacodynamic (plasma VAP-1 concentration and activity), serum and urine creatinine, serum cystatin C, albumin excretion rate, urinary albumin-to-creatinine ratio, and urine volume information', 'vascular adhesion protein-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C5198358', 'cui_str': 'ASP8232'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C5198358', 'cui_str': 'ASP8232'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3872829', 'cui_str': 'Adhesion protein'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3872829', 'cui_str': 'Adhesion protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1318439', 'cui_str': 'Creatinine measurement, urine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]",,0.0265838,The vascular adhesion protein-1,"[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Hoefman', 'Affiliation': 'LAP&P Consultants BV, Archimedesweg 31, 2333 CM, Leiden, The Netherlands. S.Hoefman@lapp.nl.'}, {'ForeName': 'Nelleke', 'Initials': 'N', 'LastName': 'Snelder', 'Affiliation': 'LAP&P Consultants BV, Archimedesweg 31, 2333 CM, Leiden, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'van Noort', 'Affiliation': 'LAP&P Consultants BV, Archimedesweg 31, 2333 CM, Leiden, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Garcia-Hernandez', 'Affiliation': 'Astellas Pharma Europe BV, Global Development, Sylviusweg 62, 2333 BE, Leiden, The Netherlands.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Onkels', 'Affiliation': 'Astellas Pharma Europe BV, Global Development, Sylviusweg 62, 2333 BE, Leiden, The Netherlands.'}, {'ForeName': 'Tobias E', 'Initials': 'TE', 'LastName': 'Larsson', 'Affiliation': 'Astellas Pharma Europe BV, Global Development, Sylviusweg 62, 2333 BE, Leiden, The Netherlands.'}, {'ForeName': 'Kirsten R', 'Initials': 'KR', 'LastName': 'Bergmann', 'Affiliation': 'Astellas Pharma Europe BV, Global Development, Sylviusweg 62, 2333 BE, Leiden, The Netherlands.'}]",Journal of pharmacokinetics and pharmacodynamics,['10.1007/s10928-020-09716-x']
2493,32929634,"Elderberry Extract Outpatient Influenza Treatment for Emergency Room Patients Ages 5 and Above: a Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Black elderberry, used medicinally for centuries, decreased influenza duration by 4 days in three previous peer-reviewed trials. US elderberry sales, possibly related to a ""high severity"" and ""high activity"" influenza season from January to March 2018, more than doubled from 2017 to 2018 to > $100 million.
OBJECTIVE


To determine whether elderberry extract decreases influenza's duration and severity.
DESIGN


FDA-approved, investigator-initiated, Investigational New Drug, double-blind, randomized, placebo-controlled trial. Conducted January 2018-April 2019 in three emergency rooms, two suburban and one urban, in the Midwestern Health System.
PATIENTS


Eighty-seven consecutive, consenting patients, over age four, with < 48 h of at least 2 moderate-severity influenza symptoms and positive polymerase chain reaction influenza test.
INTERVENTION


Patients from age 5 to 12 years received placebo or 15 ml (5.7 g) elderberry extract orally twice a day for 5 days; those > 12 years received 15 ml 4 times a day for 5 days. Patients were permitted to choose to also receive the standard dosage of oseltamivir.
MEASUREMENTS


Primary: days until all symptoms were none or mild for 21.5 h. Secondary: days to complete symptom resolution for 24 h.
RESULTS


The 87 participants were randomized to receive placebo (n = 44) or elderberry (n = 43). The average age was 25 ± 20 years, and 56% were male. The average number of days to reach all symptoms none or mild for 21.5 h in the placebo group was 4.9 ± 2.8 days compared to 5.3 ± 3.6 in the elderberry group (p = 0.57). The average number of days to complete resolution was 8.7 ± 3.8 and 8.6 ± 3.9 in the placebo and elderberry group, respectively (p = 0.87).
LIMITATIONS


Small sample size, but powered > 0.90 to detect 2-day benefit of elderberry versus placebo.
CONCLUSIONS


We found no evidence that elderberry benefits the duration or severity of influenza. Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone. Our results contradict previous studies and demonstrate the need for further studies.
TRIAL REGISTRATION


NCT03410862.",2020,Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone.,"['Eighty-seven consecutive, consenting patients, over age four, with <\u200948\xa0h of at least 2 moderate-severity influenza symptoms and positive polymerase chain reaction influenza test', 'Conducted January 2018-April 2019 in three emergency rooms, two suburban and one urban, in the Midwestern Health System', '87 participants', 'The average age was 25\u2009±\u200920\xa0years, and 56% were male', 'Emergency Room Patients Ages 5 and Above']","['elderberry extract', 'elderberry taken alone (without oseltamivir', 'placebo', 'oseltamivir', 'Elderberry Extract Outpatient Influenza Treatment', 'Placebo']","['average number of days to reach all symptoms none or mild', 'average number of days to complete resolution']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1095913', 'cui_str': 'Elderberry preparation'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",87.0,0.579061,Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Macknin', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA. macknim@ccf.org.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'C5 Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Negrey', 'Affiliation': 'Clinical Research Unit, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Mace', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06170-w']
2494,32929721,The effect of two calcıum sılıcate-based and one epoxy resın-based root canal sealer on postoperatıve paın: a randomızed controlled trıal.,"AIM


To compare the effect of two calcium silicate-based (Endoseal MTA and EndoSequence BC Sealer) and an epoxy resin-based (AH Plus) root canal sealer on postoperative pain following root canal treatment.
METHODOLOGY


Patients (n=90) having one first or second molar tooth diagnosed with asymptomatic irreversible pulpitis were randomly divided into three groups according to the sealer used (n=30) and were treated by two endodontists having at least ten years of experience. All patients received a single-visit root canal treatment. After the treatments, postoperative pain scores and analgesic intake were recorded at 6, 12, 24 and 48 hours, and 3, 4, 5, 6, and 7 days. The data were statistically analyzed with nonparametric Kruskal-Wallis tests (for the comparisons of the age and VAS scores), Friedman tests (for the assessments of the changes in pain scores over time), chi-squared tests (for the comparisons of categorical variables), and Spearman's correlation test (for the correlation assessments of the age and gender factors with postoperative pain) (α=0.05).
RESULTS


There were no significant differences among the groups in terms of postoperative pain at any time points assessed (P>0.05) nor for analgesic intake of patients among the groups (P>0.05). Analgesic intake decreased significantly after 12 hours in all groups (P<0.05).
CONCLUSIONS


The sealers tested in this study had similar levels of postoperative pain and were associated with similar intake of analgesics.",2020,"Analgesic intake decreased significantly after 12 hours in all groups (P<0.05).
",['Patients (n=90) having one first or second molar tooth diagnosed with asymptomatic irreversible pulpitis'],"['calcium silicate-based (Endoseal MTA and EndoSequence BC Sealer', 'single-visit root canal treatment', 'epoxy resin-based (AH Plus) root canal sealer', 'calcıum sılıcate-based and one epoxy resın-based root canal sealer']","['Analgesic intake', 'postoperative pain', 'analgesic intake', 'nonparametric Kruskal-Wallis tests', 'postoperative pain scores and analgesic intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0932486', 'cui_str': 'Structure of second molar tooth'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.052653,"Analgesic intake decreased significantly after 12 hours in all groups (P<0.05).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Aslan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Erciyes University, Melikgazi, Kayseri, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dönmez Özkan', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Aydın Adnan Menderes University, Efeler, Aydın, Turkey.'}]",International endodontic journal,['10.1111/iej.13411']
2495,32929783,Neuromodulation With Burst and Tonic Stimulation Decreases Opioid Consumption: A Post Hoc Analysis of the Success Using Neuromodulation With BURST (SUNBURST) Randomized Controlled Trial.,"OBJECTIVE


The SUNBURST study was a prospective, multicenter, randomized crossover trial of a single device delivering burst and tonic spinal cord stimulation (SCS) for chronic trunk and/or limb pain. We performed a post hoc analysis of opioid consumption at baseline and after device implantation.
MATERIALS AND METHODS


After implantation, 100 patients were randomized to one mode (tonic or burst) for 12 weeks, and the other mode for the subsequent 12 weeks. After the crossover period (24 weeks), patients chose their preferred mode and were assessed for one year. We analyzed 69 patients who took opioid medication at baseline. The primary endpoint was opioid consumption in morphine milligram equivalents (MMEs) at baseline and 12 months postimplantation. Subgroup analysis included opioid consumption based on Center for Disease Control markers (<50, 50-90, 90-120, >120 MME/day) and stimulation mode preference.
RESULTS


Opioid consumption at 12 months was lower compared to baseline (53.94 vs. 79.19 MME, MD -25.25, 95% CI -43.77 to 6.73, p = 0.008). By 12 months, 11 of 69 patients (15.9%) discontinued all opioid (p = 0.001). Based on CDC dose markers, the proportion of patients taking >120 MME/day decreased by 61.7% at 12 months postintervention compared to baseline (p = 0.043). Forty-five of 69 patients (65.2%) preferred burst SCS while 15 of 69 patients (21.7%) preferred tonic SCS (p < 0.001).
CONCLUSION


A device delivering tonic and burst SCS was associated with decreased opioid consumption after 12 months in patients with chronic trunk and/or limb pain. The proportion of patients reporting the highest opioid intake (>120 MME/day) decreased to a lower CDC dose category by 61.7%, carrying important implications for those at highest risk for opioid-related substance use disorder, overdose, and death.",2020,"By 12 months, 11 of 69 patients (15.9%) discontinued all opioid (p = 0.001).","['patients with chronic trunk and/or limb pain', 'chronic trunk and/or limb pain', '100 patients', '69 patients who took opioid medication at baseline']","['Neuromodulation With BURST (SUNBURST', 'Neuromodulation With Burst and Tonic Stimulation', 'single device delivering burst and tonic spinal cord stimulation (SCS']","['Opioid consumption', 'burst SCS', 'opioid consumption in morphine milligram equivalents (MMEs', 'Opioid Consumption', 'tonic SCS', 'opioid consumption based on Center for Disease Control markers', 'opioid consumption', 'highest opioid intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0030196', 'cui_str': 'Pain in limb'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0394674', 'cui_str': 'Neurostimulation/modulation'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",100.0,0.197792,"By 12 months, 11 of 69 patients (15.9%) discontinued all opioid (p = 0.001).","[{'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Rochester, MN, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Strand', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic Hospital, Phoenix, AZ, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13273']
2496,32929822,Effectiveness of patient-oriented education and medication management intervention in people with decompensated cirrhosis.,"People with chronic disease often have poor comprehension of their disease and medications, which can negatively affect health outcomes. In a randomised-controlled trial, we found that patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n = 57) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n = 59). Intervention patients also experienced improved quality of life. Dedicated resources are needed to support implementation of evidence-based measures at local centres to improve outcomes.",2020,Intervention patients also experienced improved quality of life.,"['people with decompensated cirrhosis', 'patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n =\u200957) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n =\u200959', 'People with chronic disease']",['patient-oriented education and medication management intervention'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.102154,Intervention patients also experienced improved quality of life.,"[{'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Hayward', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Valery', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Preya J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Leigh U', 'Initials': 'LU', 'LastName': 'Horsfall', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Penny L', 'Initials': 'PL', 'LastName': 'Wright', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Tallis', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Stuart', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Irvine', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'W Neil', 'Initials': 'WN', 'LastName': 'Cottrell', 'Affiliation': 'Macrophage Biology Research Group, Mater Research, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Martin', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Powell', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}]",Internal medicine journal,['10.1111/imj.14986']
2497,32929841,Effectiveness of inspiratory muscle training on respiratory fitness and breathlessness in chronic renal failure: A randomized control trial.,"BACKGROUND


People with chronic renal failure (CRF) show decreased respiratory fitness and poor quality of life (QOL). Exercise during hemodialysis has been suggested to improve the cardio-respiratory fitness. However, results of effects of respiratory muscle (RM) training on respiratory fitness and QOL are inconsistent. In addition, very few studies explored the association between inspiratory muscle (IM) training and sensation of breathlessness.
OBJECTIVES


To examine the effects of IM training in hemodialysis patients on respiratory fitness QOL and breathlessness.
METHOD


A randomized control trial with 50 CRF, who underwent hemodialysis (25 individuals in each group; IM training and sham group) was designed. Pulmonary function, RM strength, QOL (measured by Kidney Disease Quality of Life-36), and sensation of breathlessness were measured before and after an 8-week intervention.
RESULTS


Compared to the sham group, the IM strength increased in the intervention group after an 8-week program (Δ25.92 ± 8.73 cmH 2  O, p = 0.005). Significantly increased IM and forced vital capacity values in training groups was observed after an 8-week intervention (Δ12.44 ± 3.07 cmH 2  O and Δ0.097 ± 0.046 L, respectively), but not the sham group. Neither, the training group, nor the sham group were significantly different in the QOL. However, feeling of shortness of breath improved after the training program among inspiratory muscle training group, but not the sham group.
CONCLUSION


IM training during hemodialysis could lead to an improvement of respiratory fitness and reduce breathlessness in people with CRF who are receiving hemodialysis. However, QOL was not different after the training program. The study suggests that after 8-week intervention program, IM training (loading exercise) could improve IM strength, pulmonary function without any complications during the intervention program within 1-2 h.",2020,"Pulmonary function, RM strength, QOL (measured by Kidney Disease Quality of Life-36), and sensation of breathlessness were measured before and after an 8-week intervention.
","['50 CRF, who underwent hemodialysis (25 individuals in each group', 'chronic renal failure', 'hemodialysis patients on respiratory fitness QOL and breathlessness', 'People with chronic renal failure (CRF', 'people with CRF who are receiving hemodialysis']","['IM training', 'respiratory muscle (RM) training', 'IM training (loading exercise', 'inspiratory muscle training']","['inspiratory muscle (IM) training and sensation of breathlessness', 'respiratory fitness and reduce breathlessness', 'QOL', 'respiratory fitness and breathlessness', 'IM and forced vital capacity values', 'feeling of shortness of breath', 'IM strength, pulmonary function without any complications', 'IM strength', 'respiratory fitness and poor quality of life (QOL', 'Pulmonary function, RM strength, QOL (measured by Kidney Disease Quality of Life-36), and sensation of breathlessness']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",50.0,0.0144039,"Pulmonary function, RM strength, QOL (measured by Kidney Disease Quality of Life-36), and sensation of breathlessness were measured before and after an 8-week intervention.
","[{'ForeName': 'Kornanong', 'Initials': 'K', 'LastName': 'Yuenyongchaiwat', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health Sciences, Thammasat University, Khlong Nueng, Pathumthani, Thailand.'}, {'ForeName': 'Phuwarin', 'Initials': 'P', 'LastName': 'Namdang', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health Sciences, Thammasat University, Khlong Nueng, Pathumthani, Thailand.'}, {'ForeName': 'Phatsara', 'Initials': 'P', 'LastName': 'Vasinsarunkul', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health Sciences, Thammasat University, Khlong Nueng, Pathumthani, Thailand.'}, {'ForeName': 'Phoomipat', 'Initials': 'P', 'LastName': 'Phongsukree', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health Sciences, Thammasat University, Khlong Nueng, Pathumthani, Thailand.'}, {'ForeName': 'Kodchaphan', 'Initials': 'K', 'LastName': 'Chaturattanachaiyaporn', 'Affiliation': 'Physiotherapy Department, Faculty of Allied Health Sciences, Thammasat University, Khlong Nueng, Pathumthani, Thailand.'}, {'ForeName': 'Sasipim', 'Initials': 'S', 'LastName': 'Pairojkittrakul', 'Affiliation': 'Nephrology Clinic, Thammasat University Hospital, Khlong Nueng, Pathumthani, Thailand.'}, {'ForeName': 'Opas', 'Initials': 'O', 'LastName': 'Traitanon', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Faculty of Medicine, Thammasat University, Khlong Nueng, Pathumthani, Thailand.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1879']
2498,32926010,Azithromycin for chronic eosinophilic rhinosinusitis with nasal polyp: a placebo-controlled trial.,"BACKGROUND


Chronic eosinophilic rhinosinusitis with nasal polyps (CRSwNP eosinophilic) is characterised by the formation of benign and bilateral nasal polyps. We aimed to compare the effectiveness of azithromycin as an immunomodulator with the use of a placebo in patients presenting with CRSwNP concomitant with asthma and aspirin intolerance after 3 months of treatment and at a 1-year follow-up.
METHODOLOGY


We performed a randomised, double-blind, placebo-controlled trial. Patients received 500 mg azithromycin orally three times/week for 12 weeks. Improvement was evaluated by staging, the Sino-Nasal Outcome Test (SNOT-22), and nasal polyp biopsy. Data collected at pretreatment and 3 months posttreatment were compared. Quality of life was evaluated at the 1-year follow-up.
RESULTS


Twenty-seven and 21 patients were treated with azithromycin and a placebo, respectively. The medication was well tolerated overall. Twenty patients (74%) in the azithromycin group and three patients (14%) in the placebo group were not refer- red for surgery at the end of the 3-month treatment. Regarding subjective improvement, there was a median decrease only in the azithromycin group, and the between-group difference was significant. SNOT-22 improvement was maintained in the azithromy- cin group at the 1-year follow-up.
CONCLUSIONS


Azithromycin could be considered a therapeutic option for patients presenting with CRSwNP concomitant with asthma and aspirin intolerance.",2020,"SNOT-22 improvement was maintained in the azithromy- cin group at the 1-year follow-up.
","['chronic eosinophilic rhinosinusitis with nasal polyp', 'Chronic eosinophilic rhinosinusitis with nasal polyps (CRSwNP eosinophilic', 'patients presenting with CRSwNP concomitant with asthma and aspirin intolerance', 'patients presenting with CRSwNP concomitant with asthma and aspirin intolerance after 3 months of treatment and at a 1-year follow-up', 'Twenty-seven and 21 patients were treated with']","['Azithromycin', 'placebo', 'azithromycin']","['Quality of life', 'SNOT-22 improvement', 'Sino-Nasal Outcome Test (SNOT-22), and nasal polyp biopsy']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",,0.0998238,"SNOT-22 improvement was maintained in the azithromy- cin group at the 1-year follow-up.
","[{'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'de Oliveira', 'Affiliation': 'Post Graduate Program in Surgery and Ophthalmology, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Guimaraes', 'Affiliation': 'Resident Physician of Craniomaxillofacial Surgery of the Hospital das Clínicas, UFMG, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Arantes Pêgas', 'Affiliation': 'Undergraduate student of the Department of General Pathology, UFMG, Belo Horizonte, Minas Gerais,Brazil.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Machado', 'Affiliation': 'Department of Preventive and Social Medicine, UFMG, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Cassali', 'Affiliation': 'Department of General Pathology, UFMG, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barbosa Nunes', 'Affiliation': 'Department of Ophthalmology and Otolaryngology, UFMG, Belo Horizonte, Minas Gerais,Brazil.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Gonçalves Becker', 'Affiliation': 'Department of Ophthalmology and Otolaryngology, UFMG, Belo Horizonte, Minas Gerais,Brazil.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Santos Guimarães', 'Affiliation': 'Department of Ophthalmology and Otolaryngology, UFMG, Belo Horizonte, Minas Gerais,Brazil.'}]",Rhinology,['10.4193/Rhin20.071']
2499,32926117,Effect of Transcranial Low-Level Light Therapy vs Sham Therapy Among Patients With Moderate Traumatic Brain Injury: A Randomized Clinical Trial.,"Importance


Preclinical studies have shown that transcranial near-infrared low-level light therapy (LLLT) administered after traumatic brain injury (TBI) confers a neuroprotective response.
Objectives


To assess the feasibility and safety of LLLT administered acutely after a moderate TBI and the neuroreactivity to LLLT through quantitative magnetic resonance imaging metrics and neurocognitive assessment.
Design, Setting, and Participants


A randomized, single-center, prospective, double-blind, placebo-controlled parallel-group trial was conducted from November 27, 2015, through July 11, 2019. Participants included 68 men and women with acute, nonpenetrating, moderate TBI who were randomized to LLLT or sham treatment. Analysis of the response-evaluable population was conducted.
Interventions


Transcranial LLLT was administered using a custom-built helmet starting within 72 hours after the trauma. Magnetic resonance imaging was performed in the acute (within 72 hours), early subacute (2-3 weeks), and late subacute (approximately 3 months) stages of recovery. Clinical assessments were performed concomitantly and at 6 months via the Rivermead Post-Concussion Questionnaire (RPQ), a 16-item questionnaire with each item assessed on a 5-point scale ranging from 0 (no problem) to 4 (severe problem).
Main Outcomes and Measures


The number of participants to successfully and safely complete LLLT without any adverse events within the first 7 days after the therapy was the primary outcome measure. Secondary outcomes were the differential effect of LLLT on MR brain diffusion parameters and RPQ scores compared with the sham group.
Results


Of the 68 patients who were randomized (33 to LLLT and 35 to sham therapy), 28 completed at least 1 LLLT session. No adverse events referable to LLLT were reported. Forty-three patients (22 men [51.2%]; mean [SD] age, 50.49 [17.44] years]) completed the study with at least 1 magnetic resonance imaging scan: 19 individuals in the LLLT group and 24 in the sham treatment group. Radial diffusivity (RD), mean diffusivity (MD), and fractional anisotropy (FA) showed significant time and treatment interaction at 3-month time point (RD: 0.013; 95% CI, 0.006 to 0.019; P < .001; MD: 0.008; 95% CI, 0.001 to 0.015; P = .03; FA: -0.018; 95% CI, -0.026 to -0.010; P < .001).The LLLT group had lower RPQ scores, but this effect did not reach statistical significance (time effect P = .39, treatment effect P = .61, and time × treatment effect P = .91).
Conclusions and Relevance


In this randomized clinical trial, LLLT was feasible in all patients and did not exhibit any adverse events. Light therapy altered multiple diffusion tensor parameters in a statistically significant manner in the late subacute stage. This study provides the first human evidence to date that light therapy engages neural substrates that play a role in the pathophysiologic factors of moderate TBI and also suggests diffusion imaging as the biomarker of therapeutic response.
Trial Registration


ClinicalTrials.gov Identifier: NCT02233413.",2020,"Radial diffusivity (RD), mean diffusivity (MD), and fractional anisotropy (FA) showed significant time and treatment interaction at 3-month time point (RD: 0.013; 95% CI, 0.006 to 0.019; P < .001; MD: 0.008; 95% CI, 0.001 to 0.015; P = .03; FA: -0.018; 95% CI, -0.026 to -0.010;","['Forty-three patients (22 men [51.2%]; mean [SD] age, 50.49 [17.44] years]) completed the study with at least 1 magnetic resonance imaging scan: 19 individuals in the LLLT group and 24 in the sham treatment group', '68 patients who were randomized (33 to', 'Participants included 68 men and women with acute, nonpenetrating, moderate TBI who were randomized to', 'Patients With Moderate Traumatic Brain Injury']","['LLLT', 'Magnetic resonance imaging', 'Transcranial Low-Level Light Therapy vs Sham Therapy', 'Transcranial LLLT', 'placebo', 'transcranial near-infrared low-level light therapy (LLLT']","['RPQ scores', 'Radial diffusivity (RD), mean diffusivity (MD), and fractional anisotropy (FA', 'feasibility and safety', 'differential effect of LLLT on MR brain diffusion parameters and RPQ scores']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",68.0,0.558471,"Radial diffusivity (RD), mean diffusivity (MD), and fractional anisotropy (FA) showed significant time and treatment interaction at 3-month time point (RD: 0.013; 95% CI, 0.006 to 0.019; P < .001; MD: 0.008; 95% CI, 0.001 to 0.015; P = .03; FA: -0.018; 95% CI, -0.026 to -0.010;","[{'ForeName': 'Maria Gabriela', 'Initials': 'MG', 'LastName': 'Figueiro Longo', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Can Ozan', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Welt', 'Affiliation': 'School of Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Avesta', 'Affiliation': 'Department of Radiology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ratai', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Nathaniel David', 'Initials': 'ND', 'LastName': 'Mercaldo', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Yendiki', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Boston, Massachusetts.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Namati', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Chico-Calero', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Blair A', 'Initials': 'BA', 'LastName': 'Parry', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Drake', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Rox', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Rauch', 'Affiliation': 'Office of Secretary of Defense, Department of Defense, Washington, DC.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Diaz-Arrastia', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lev', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Jarone', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hamblin', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Vakoc', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.17337']
2500,32928122,Time to adapt in the pandemic era: a prospective randomized non -inferiority study comparing time to intubate with and without the barrier box.,"BACKGROUND


The challenges posed by the spread of COVID-19 disease through aerosols have compelled anesthesiologists to modify their airway management practices. Devices such as barrier boxes are being considered as potential adjuncts to full PPE's to limit the aerosol spread. Usage of the barrier box raises concerns of delay in time to intubate (TTI). We designed our study to determine if using a barrier box with glidescope delays TTI within acceptable parameters to make relevant clinical conclusions.
METHODS


Seventy-eight patients were enrolled in this prospective non-inferiority controlled trial and were randomly allocated to either group C (without the barrier box) or the study group BB (using barrier box). The primary measured endpoint is time to intubate (TTI), which is defined as time taken from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end-tidal CO  2.  15 s was used as non-inferiority margin for the purpose of the study. We used an unpaired two-sample single-sided t-test to test our non- inferiority hypothesis (H  0 : Mean TTI diff ≥15 s, H  A : Mean TTI diff < 15 s). Secondary endpoints include the number of attempts at intubation, lowest oxygen saturation during induction, and the need for bag-mask ventilation.
RESULTS


Mean TTI in group C was 42 s (CI 19.2 to 64.8) vs. 52.1 s (CI 26.1 to 78) in group BB. The difference in mean TTI was 10.1 s (CI -∞ to 14.9). We rejected the null hypothesis and concluded with 95% confidence that the difference of the mean TTI between the groups is less than < 15 s (95% CI -∞ to 14.9,p = 0.0461). Our induction times were comparable (67.7 vs. 65.9 s).100% of our patients were intubated on the first attempt in both groups. None of our patients needed rescue breaths.
CONCLUSIONS


We conclude that in patients with normal airway exam, scheduled for elective surgeries, our barrier box did not cause any clinically significant delay in TTI when airway manipulation is performed by well-trained providers. The study was retrospectively registered at clinicaltrials.gov (NCT04411056) on May 27, 2020.",2020,Mean TTI in group C was 42 s (CI 19.2 to 64.8) vs. 52.1 s (CI 26.1 to 78) in group BB.,"['Seventy-eight patients were enrolled in this prospective non-inferiority controlled trial', 'patients with normal airway exam, scheduled for elective surgeries']",['non- inferiority hypothesis (H  0 '],"['mean TTI', 'number of attempts at intubation, lowest oxygen saturation during induction, and the need for bag-mask ventilation', 'Mean TTI', 'time to intubate (TTI), which is defined as time taken from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end-tidal CO  2']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0336651', 'cui_str': 'Peripheral neurostimulator'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0444930', 'cui_str': 'End'}]",78.0,0.0876629,Mean TTI in group C was 42 s (CI 19.2 to 64.8) vs. 52.1 s (CI 26.1 to 78) in group BB.,"[{'ForeName': 'Praneeth', 'Initials': 'P', 'LastName': 'Madabhushi', 'Affiliation': 'Department of Anesthesiology, Robert Packer Hospital, Guthrie Clinic, 1 Guthrie Square, Sayre, PA, 18840, USA. praneeth.madabhushi@guthrie.org.'}, {'ForeName': 'Sudhakar', 'Initials': 'S', 'LastName': 'Kinthala', 'Affiliation': 'Department of Anesthesiology, Robert Packer Hospital, Guthrie Clinic, 1 Guthrie Square, Sayre, PA, 18840, USA.'}, {'ForeName': 'Abistanand', 'Initials': 'A', 'LastName': 'Ankam', 'Affiliation': 'Department of Anesthesiology, Robert Packer Hospital, Guthrie Clinic, 1 Guthrie Square, Sayre, PA, 18840, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Chopra', 'Affiliation': 'Department of Anesthesiology, Robert Packer Hospital, Guthrie Clinic, 1 Guthrie Square, Sayre, PA, 18840, USA.'}, {'ForeName': 'Burdett R', 'Initials': 'BR', 'LastName': 'Porter', 'Affiliation': 'Department of Anesthesiology, Robert Packer Hospital, Guthrie Clinic, 1 Guthrie Square, Sayre, PA, 18840, USA.'}]",BMC anesthesiology,['10.1186/s12871-020-01149-w']
2501,32928123,Relative abundance of the Prevotella genus within the human gut microbiota of elderly volunteers determines the inter-individual responses to dietary supplementation with wheat bran arabinoxylan-oligosaccharides.,"BACKGROUND


The human colon is colonised by a dense microbial community whose species composition and metabolism are linked to health and disease. The main energy sources for colonic bacteria are dietary polysaccharides and oligosaccharides. These play a major role in modulating gut microbial composition and metabolism, which in turn can impact on health outcomes.
RESULTS


We investigated the influence of wheat bran arabinoxylan oligosaccharides (AXOS) and maltodextrin supplements in modulating the composition of the colonic microbiota and metabolites in healthy adults over the age of 60. Male and female volunteers, (n = 21, mean BMI 25.2 ± 0.7 kg/m 2 ) participated in the double-blind, cross over supplement study. Faecal samples were collected for analysis of microbiota, short chain fatty acids levels and calprotectin. Blood samples were collected to measure glucose, cholesterol and triglycerides levels. There was no change in these markers nor in calprotectin levels in response to the supplements. Both supplements were well-tolerated by the volunteers. Microbiota analysis across the whole volunteer cohort revealed a significant increase in the proportional abundance of faecal Bifidobacterium species (P ≤ 0.01) in response to AXOS, but not maltodextrin, supplementation. There was considerable inter-individual variation in the other bacterial taxa that responded, with a clear stratification of volunteers as either Prevotella-plus (n = 8; > 0.1% proportional abundance) or Prevotella-minus (n = 13; ≤0.1% proportional abundance) subjects founded on baseline sample profiles. There was a significant increase in the proportional abundance of both faecal Bifidobacterium (P ≤ 0.01) and Prevotella species (P ≤ 0.01) in Prevotella-plus volunteers during AXOS supplementation, while Prevotella and Bacteroides relative abundances showed an inverse relationship. Proportional abundance of 26 OTUs, including bifidobacteria and Anaerostipes hadrus, differed significantly between baseline samples of Prevotella-plus compared to Prevotella-minus individuals.
CONCLUSIONS


The wheat bran AXOS supplementation was bifidogenic and resulted in changes in human gut microbiota composition that depended on the initial microbiota profile, specifically the presence or absence of Prevotella spp. as a major component of the microbiota. Our data therefore suggest that initial profiling of individuals through gut microbiota analysis should be considered important when contemplating nutritional interventions that rely on prebiotics.
TRIAL REGISTRATION


Clinical trial registration number: NCT02693782 . Registered 29 February 2016 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02693782?term=NCT02693782&rank=1.",2020,"There was a significant increase in the proportional abundance of both faecal Bifidobacterium (P ≤ 0.01) and Prevotella species (P ≤ 0.01) in Prevotella-plus volunteers during AXOS supplementation, while Prevotella and Bacteroides relative abundances showed an inverse relationship.","['Registered 29 February 2016 ', 'healthy adults over the age of 60', 'elderly volunteers', 'Male and female volunteers, (n\u2009=\u200921, mean BMI 25.2\u2009±\u20090.7\u2009kg/m 2 ) participated in the double-blind, cross over supplement study']",['wheat bran arabinoxylan oligosaccharides (AXOS) and maltodextrin supplements'],"['proportional abundance of faecal Bifidobacterium species', 'Proportional abundance of 26 OTUs, including bifidobacteria and Anaerostipes hadrus', 'proportional abundance of both faecal Bifidobacterium', 'glucose, cholesterol and triglycerides levels', 'tolerated', 'calprotectin levels']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0043138', 'cui_str': 'Wheat bran'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1019337', 'cui_str': 'Otus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1224225', 'cui_str': 'Anaerostipes'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0637927,"There was a significant increase in the proportional abundance of both faecal Bifidobacterium (P ≤ 0.01) and Prevotella species (P ≤ 0.01) in Prevotella-plus volunteers during AXOS supplementation, while Prevotella and Bacteroides relative abundances showed an inverse relationship.","[{'ForeName': 'Wing Sun Faith', 'Initials': 'WSF', 'LastName': 'Chung', 'Affiliation': 'Gut Health Group, Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Walker', 'Affiliation': 'Gut Health Group, Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK.'}, {'ForeName': 'Douwina', 'Initials': 'D', 'LastName': 'Bosscher', 'Affiliation': 'Cargill R&D Centre Europe BVBA, Havenstraat 84, B-1800, Vilvoorde, Belgium.'}, {'ForeName': 'Vicenta', 'Initials': 'V', 'LastName': 'Garcia-Campayo', 'Affiliation': 'Cargill, Incorporated, PO Box 9300, Minneapolis, MN, 55440-9300, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'Pathogen Genomics Group, Wellcome Sanger Institute, Hinxton, Cambridgeshire, CB10 1SA, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Parkhill', 'Affiliation': 'Department of Veterinary Medicine, University of Cambridge, Madingley Road, Cambridge, CB3 0ES, UK.'}, {'ForeName': 'Sylvia H', 'Initials': 'SH', 'LastName': 'Duncan', 'Affiliation': 'Gut Health Group, Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK. sylvia.duncan@abdn.ac.uk.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Flint', 'Affiliation': 'Gut Health Group, Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, Scotland, AB25 2ZD, UK.'}]",BMC microbiology,['10.1186/s12866-020-01968-4']
2502,32928179,Impact of integrated district level mental health care on clinical and functioning outcomes of people with depression and alcohol use disorder in Nepal: a non-randomised controlled study.,"BACKGROUND


Integration of mental health services into primary healthcare is proliferating in low-resource countries. We aimed to evaluate the impact of different compositions of primary care mental health services for depression and alcohol use disorder (AUD), when compared to usual primary care services.
METHODS


We conducted a non-randomized controlled study in rural Nepal. We compared treatment outcomes among patients screening positive and receiving: (a) primary care mental health services without a psychological treatment component (TG); (b) the same services including a psychological treatment (TG + P); and (c) primary care treatment as usual (TAU). Primary outcomes included change in depression and AUD symptoms, as well as disability. Disability was measured using the 12-item WHO Disability Assessment Schedule. Symptom severity was assessed using the 9-item Patient Health Questionnaire for depression, the 10-item Alcohol Use Disorders Identification Test for AUD. We used negative binomial regression models for the analysis.
RESULTS


For depression, when combining both treatment groups (TG, n = 77 and TG + P, n = 60) compared to TAU (n = 72), there were no significant improvements. When only comparing the psychological treatment group (TG + P) with TAU, there were significant improvements for symptoms and disability (aβ = - 2.64; 95%CI - 4.55 to - 0.74, p = 0.007; aβ = - 12.20; 95%CI - 19.79 to - 4.62; p = 0.002, respectively). For AUD, when combining both treatment groups (TG, n = 92 and TG + P, n = 80) compared to TAU (n = 57), there were significant improvements in AUD symptoms and disability (aβ = - 15.13; 95%CI - 18.63 to - 11.63, p < 0.001; aβ = - 9.26; 95%CI - 16.41 to - 2.12, p = 0.011; respectively). For AUD, there were no differences between TG and TG + P. Patients' perceptions of health workers' skills in common psychological factors were associated with improvement in depression patient outcomes (β = - 0.36; 95%CI - 0.55 to - 0.18; p < 0.001) but not for AUD patients.
CONCLUSION


Primary care mental health services for depression may only be effective when psychological treatments are included. Health workers' competencies as perceived by patients may be an important indicator for treatment effect. AUD treatment in primary care appears to be beneficial even without additional psychological services.",2020,"When only comparing the psychological treatment group (TG + P) with TAU, there were significant improvements for symptoms and disability (aβ = - 2.64; 95%CI - 4.55 to - 0.74, p = 0.007; aβ = - 12.20; 95%CI - 19.79 to - 4.62; p = 0.002, respectively).","['rural Nepal', 'patients screening positive and receiving: (a) primary care mental health services without a psychological treatment component (TG); (b) the same services including a', 'people with depression and alcohol use disorder in Nepal']","['primary care mental health services', 'integrated district level mental health care', 'psychological treatment (TG\u2009+\u2009P); and (c) primary care treatment as usual (TAU']","['9-item Patient Health Questionnaire for depression, the 10-item Alcohol Use Disorders Identification Test for AUD', 'Disability', 'Symptom severity', 'change in depression and AUD symptoms, as well as disability', 'AUD symptoms and disability', 'depression patient outcomes', 'symptoms and disability', '12-item WHO Disability Assessment Schedule']","[{'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule'}]",,0.147044,"When only comparing the psychological treatment group (TG + P) with TAU, there were significant improvements for symptoms and disability (aβ = - 2.64; 95%CI - 4.55 to - 0.74, p = 0.007; aβ = - 12.20; 95%CI - 19.79 to - 4.62; p = 0.002, respectively).","[{'ForeName': 'M J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Garman', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization (TPO), Nepal, Kathmandu, Nepal. luitelnp@gmail.com.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Transcultural Psychosocial Organization (TPO), Nepal, Kathmandu, Nepal.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Harvard Medical School, Boston, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Stellenbosch, South Africa.'}]",BMC psychiatry,['10.1186/s12888-020-02832-5']
2503,32928184,"The effect of a stress and anxiety coping program on objective structured clinical examination performance among nursing students in shiraz, Iran.","BACKGROUND


Evaluation of the competence and practical skills of nursing students, using the objective structured clinical examination (OSCE), is an integral part of the nursing education program. However, their performance could be negatively influenced by a significant level of stress and anxiety prior to the test. The present study aimed to evaluate the effect of an anxiety coping program on the OSCE performance level of first-year nursing students in Shiraz, Iran.
METHODS


The present quasi-experimental study was conducted among 76 nursing students; control group (n = 35) and intervention group (n = 41). To attain the study purpose, the intervention group received a pre-exam anxiety coping program that included relaxation and soothing techniques, diaphragmatic breathing training, and progressive muscle relaxation training accompanied by light instrumental music, while the control group received no intervention before the exam. Data collection instruments included a demographic characteristics form and State-Trait Anxiety Inventory (STAI) questionnaire. Demographic characteristics of the participants indicated an overall homogeneity within the study population. The STAI questionnaire was filled in before and after the OSCE and the results were compared with those of the control group. The data were analysed using SPSS software (version 22.0). P < 0.05 was considered statistically significant.
RESULTS


As a result of the anxiety coping program, a substantial reduction in the anxiety score (by 11.61 units) in the intervention group was observed. There was a significant difference in the pre- and post-exam anxiety scores between the control and intervention groups (P < 0.001). The anxiety coping program improved the examination results of nursing students in the final exam compared to the midterm results (an increase of 0.9487 units, P < 0.001).
CONCLUSION


The anxiety coping program reduced the anxiety level among nursing students and improved their OSCE results. Our findings can be utilized to better evaluate clinical activities in different medical and paramedical groups. Moreover, educators can implement such coping programs prior to evaluations in order to effectively assess the knowledge, attitude, and performance of the students.",2020,"As a result of the anxiety coping program, a substantial reduction in the anxiety score (by 11.61 units) in the intervention group was observed.","['nursing students in shiraz, Iran', '76 nursing students; control group (n\u2009=\u200935) and intervention group (n\u2009=\u200941', 'nursing students', 'first-year nursing students in Shiraz, Iran.\nMETHODS']","['pre-exam anxiety coping program that included relaxation and soothing techniques, diaphragmatic breathing training, and progressive muscle relaxation training accompanied by light instrumental music, while the control group received no intervention before the exam', 'stress and anxiety coping program', 'anxiety coping program']","['anxiety score', 'demographic characteristics form and State-Trait Anxiety Inventory (STAI) questionnaire', 'anxiety level', 'OSCE performance level', 'STAI questionnaire', 'pre- and post-exam anxiety scores']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",76.0,0.0159787,"As a result of the anxiety coping program, a substantial reduction in the anxiety score (by 11.61 units) in the intervention group was observed.","[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Mojarrab', 'Affiliation': 'Medical Education Department, Medical Education Development Centre, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Bazrafkan', 'Affiliation': 'Clinical Education Research Centre, Education Developmental Centre, Shiraz University of Medical Sciences, Sina-Sadra Halls Complex, Neshat Ave, Shiraz, Postcode: 7134874689, Iran. l.bazrafkan@yahoo.com.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Jaberi', 'Affiliation': 'Community Based Psychiatric Care Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",BMC medical education,['10.1186/s12909-020-02228-9']
2504,32928185,Women's views about physical activity as a treatment for vasomotor menopausal symptoms: a qualitative study.,"BACKGROUND


Women commonly seek medical advice about menopausal symptoms. Although menopausal hormone therapy is the most effective treatment, many women prefer non-pharmacological treatments, such as physical activity. The effectiveness of physical activity has been inconclusive when assessed by randomised controlled trials, and it remains unclear how women feel about it as a possible treatment approach. The aim of the study was to explore symptomatic menopausal women's views and experiences of physical activity as a treatment for vasomotor and other menopausal symptoms.
METHODS


An in-depth qualitative study was embedded within a randomised controlled trial that assessed the effectiveness of physical activity as a treatment for vasomotor menopausal symptoms in previously inactive vasomotor symptomatic women. Participants were randomised to one of two physical activity interventions or a usual care group. Both physical activity interventions involved two one-to-one consultations, plus either supporting materials or access to physical activity support groups, over 6 months. Semi-structured interviews were conducted with 17 purposively selected participants from all three trial groups after they had completed trial follow-up. Interviews were audio recorded, transcribed verbatim, and analysed by constant comparison.
RESULTS


All participants talked positively about physical activity as a treatment for their menopausal symptoms, with most reporting participation had improved their hot flushes and night sweats. They reported that they had experienced improved sleep, physical health and psychological well-being. Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved. Many participants commented that they would prefer doctors to discuss physical activity as a possible treatment for their hot flushes and night sweats, before offering medication.
CONCLUSIONS


Based on the views and experiences of the women who participated in this study, healthcare professionals should continue discussing physical activity as a potential first treatment option with menopausal women. Furthermore, healthcare professionals should ensure they prepare, support, and encourage these women both physically and emotionally.
TRIAL REGISTRATION


ISRCTN ISRCTN06495625 Registered 10/11/2010.",2020,Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved.,"['previously inactive vasomotor symptomatic women', 'Semi-structured interviews were conducted with 17 purposively selected participants from all three trial groups after they had completed trial follow-up']","['physical activity interventions or a usual care group', 'physical activity plus social-support intervention', 'menopausal hormone therapy', 'physical activity']","['hot flushes and night sweats', 'vasomotor menopausal symptoms', 'sleep, physical health and psychological well-being']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}]",17.0,0.085535,Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved.,"[{'ForeName': 'Adèle', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Office of HDR Training and Partnerships, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, UK. a.daley@lboro.ac.uk.'}]",BMC women's health,['10.1186/s12905-020-01063-w']
2505,32928196,Adaptive tutorials versus web-based resources in radiology: a mixed methods analysis in junior doctors of efficacy and engagement.,"BACKGROUND


Radiology education is limited in undergraduate Medicine programs. Junior doctors might not have the necessary background to effectively order and interpret diagnostic imaging investigations. Furthermore, junior doctors are often time-poor, balancing clinical commitments with ongoing learning, leadership and teaching responsibilities. Previous studies have demonstrated the efficacy of radiology-themed online adaptive tutorials for senior medical students. Such adaptive tutorials might therefore be an efficient and effective form of radiology education for junior doctors.
METHODS


A randomised controlled crossover trial was performed to evaluate the impact of adaptive tutorials on learning the indications for, and interpretation of, basic imaging studies, compared with peer-reviewed web-based resources. Ninety-one volunteer junior doctors, comprising 53 postgraduate year 1 (PGY 1) and 38 postgraduate year 2 (PGY 2), were randomly allocated into two groups. In the first phase of the trial, focusing on head CT, one group accessed adaptive tutorials while the other received web-based resources. In the second phase of the trial, focusing on chest CT, the groups crossed over. Following each phase of the trial, participants completed exam-style online assessments. At the conclusion of the study, participants also completed an online questionnaire regarding perceived engagement and efficacy of each type of educational resource.
RESULTS


Junior doctors completed the adaptive tutorials significantly faster than the relevant web-based resources for both head CT and chest CT (p = 0.03 and < 0.01 respectively). Mean quiz scores were higher in the groups receiving adaptive tutorials on head CT and chest CT (86.4% vs 83.5 and 77.7% vs 75% respectively). However, in contrast to previous studies in senior medical students, these differences were not statistically significant. Participants reported higher engagement and perceived value of adaptive tutorials, compared with web-based resources.
CONCLUSIONS


Adaptive tutorials are more time-efficient than existing web-based resources for learning radiology by junior doctors, while both types of resources were equally effective for learning in this cohort. Junior doctors found the adaptive tutorials more engaging and were more likely to recommend these resources to their colleagues.",2020,"RESULTS


Junior doctors completed the adaptive tutorials significantly faster than the relevant web-based resources for both head CT and chest CT (p = 0.03 and < 0.01 respectively).","['Ninety-one volunteer junior doctors, comprising 53 postgraduate year 1 (PGY 1) and 38 postgraduate year 2 (PGY 2', 'senior medical students']",['Adaptive tutorials versus web-based resources in radiology'],"['Mean quiz scores', 'higher engagement and perceived value of adaptive tutorials', 'head CT and chest CT']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202691', 'cui_str': 'CT of head'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}]",91.0,0.0572659,"RESULTS


Junior doctors completed the adaptive tutorials significantly faster than the relevant web-based resources for both head CT and chest CT (p = 0.03 and < 0.01 respectively).","[{'ForeName': 'Stuart W T', 'Initials': 'SWT', 'LastName': 'Wade', 'Affiliation': 'Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moscova', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Nicodemus', 'Initials': 'N', 'LastName': 'Tedla', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Moses', 'Affiliation': 'Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Young', 'Affiliation': 'Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Merribel', 'Initials': 'M', 'LastName': 'Kyaw', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Velan', 'Affiliation': 'School of Medical Sciences, Faculty of Medicine, The University of New South Wales, Sydney, Australia. g.velan@unsw.edu.au.'}]",BMC medical education,['10.1186/s12909-020-02237-8']
2506,32928298,Meaningful Activities and Recovery (MA&R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement-study protocol for a randomized controlled trial.,"BACKGROUND


Engagement in activities meaningful to the individual may support the process of recovery in those with mental illness. Persons with psychiatric disabilities may reduce their engagement in meaningful activities to various degrees with possible fluctuations over time. We hypothesized that activity engagement can be altered when opportunities and support are offered at an individual and a group peer-based level. Evidence is lacking regarding mental health interventions that enable engagement in meaningful activities, and powered effect studies are warranted.
METHODS


We propose an 8-month combined individual and group peer-based intervention, Meaningful Activities and Recovery (MA&R), and a study protocol for a multicentre two-armed parallel randomized controlled trial (RCT). The trial investigates the effects of MA&R in community mental health centres in Copenhagen and municipality services in Denmark. The trial will comprise 128 participants with psychiatric disabilities who will be randomized to one of two groups: (1) MA&R in addition to standard mental healthcare or (2) standard mental healthcare alone. The primary outcome is self-reported activity engagement, measured by Profiles of Engagement in People with Severe Mental Illness. Secondary outcomes are recovery, functioning and quality of life. Data will be collected at baseline and at follow-up at the end of the intervention.
DISCUSSION


This study adds new knowledge to a field with limited evidence, i.e. the clinical effectiveness of rehabilitation interventions among people with psychiatric disabilities, directly targeting activity engagement. The pragmatic design, regarding in- and exclusion criteria and settings, may allow assessment of the intervention's effect under real-life conditions. The randomization, adequate power and fidelity monitoring allow testing of the intervention's efficacy. The multicentre study design increases the potential for implementation in various mental health settings if the findings are positive. As the nature of the intervention does not permit blinding of the participants or staff, it may increase the risk of expectancy and performance bias. This must be considered when interpreting the findings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03963245 . Registered on 29 May 2019.",2020,"We propose an 8-month combined individual and group peer-based intervention, Meaningful Activities and Recovery (MA&R), and a study protocol for a multicentre two-armed parallel randomized controlled trial (RCT).","['community mental health centres in Copenhagen and municipality services in Denmark', '128 participants with psychiatric disabilities', 'people with psychiatric disabilities', 'Persons with psychiatric disabilities', 'persons with psychiatric disabilities on activity engagement-study protocol']","['MA&R', 'combined individual and group peer-based intervention, Meaningful Activities and Recovery (MA&R', 'MA&R in addition to standard mental healthcare or (2) standard mental healthcare alone', 'novel rehabilitation intervention', 'rehabilitation interventions']","['recovery, functioning and quality of life', 'Meaningful Activities and Recovery (MA&R', 'self-reported activity engagement, measured by Profiles of Engagement in People with Severe Mental Illness']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",128.0,0.295792,"We propose an 8-month combined individual and group peer-based intervention, Meaningful Activities and Recovery (MA&R), and a study protocol for a multicentre two-armed parallel randomized controlled trial (RCT).","[{'ForeName': 'Siv Therese Bogevik', 'Initials': 'STB', 'LastName': 'Bjørkedal', 'Affiliation': 'Team for Inclusion and Recovery, CORE: Copenhagen Research Center for Mental Health, Gentofte Hospitalsvej 15, opg. 3A, 2900, Hellerup, Denmark. Siv-Therese.Bogevik.Bjoerkedal@regionh.dk.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Bejerholm', 'Affiliation': 'Department of Health Sciences, Mental Health, Activity and Participation (MAP), Centre for Evidence Based Psychosocial Interventions (CEPI), Lund University, Box 157, SE-221 00, Lund, Sweden.'}, {'ForeName': 'Lene Falgaard', 'Initials': 'LF', 'LastName': 'Eplov', 'Affiliation': 'Team for Inclusion and Recovery, CORE: Copenhagen Research Center for Mental Health, Gentofte Hospitalsvej 15, opg. 3A, 2900, Hellerup, Denmark.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Møller', 'Affiliation': 'CKO University Hospital of Copenhagen Rigshospitalet dep. 8513, 2100, Copenhagen East, Denmark.'}]",Trials,['10.1186/s13063-020-04722-3']
2507,32928313,"A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients. 2- To determine the salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL- 17 among COVID-19 patients subjected to 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles.
TRIAL DESIGN


This will be a parallel group, quadruple blind-randomised controlled pilot trial with an add on laboratory based study.
PARTICIPANTS


A non-probability, purposive sampling technique will be followed to identify participants for this study. The clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. The viral PCR tests will be done at main AKUH clinical laboratories whereas the immunological tests (cytokine analysis) will be done at the Juma research laboratory of AKUH. The inclusion criteria are laboratory-confirmed COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH. Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients will be excluded. Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus.
INTERVENTION AND COMPARATOR


Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc.) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products Inc./ ActiveOxy® by Boumatic Inc.) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer. After each use, the patient is asked not to eat, drink, or rinse their mouth for the next 30 minutes.
MAIN OUTCOMES


The primary outcome is the reduction in the intra-oral viral load confirmed with real time quantitative PCR.
RANDOMISATION


The assignment to the study group/ allocation will be done using the sealed envelope method under the supervision of Clinical Trial Unit (CTU) of Aga Khan University, Karachi, Pakistan. The patients will be randomised to their respective study group (1:1:1:1:1 allocation ratio) immediately after the eligibility assessment and consent administration is done.
BLINDING (MASKING)


The study will be quadruple-blinded. Patients, intervention provider, outcome assessor and the data collection officer will be blinded. The groups will be labelled as A, B, C, D or E. The codes of the intervention will be kept in lock & key at the CTU and will only be revealed at the end of study or if the study is terminated prematurely.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig. 1 for details.
TRIAL STATUS


Protocol version is 7.0, approved by the department and institutional ethics committees and clinical trial unit of the university hospital. Recruitment is planned to start as soon as the funding is sanctioned. The total duration of the study is expected to be 6 months i.e. August 2020-January 2021.
TRIAL REGISTRATION


This study protocol was registered at www.clinicaltrials.gov on 10 April 2020 NCT04341688 .
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). Fig. 1 Flow diagram of study-participants' timeline.",2020,Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients.,"['Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients', 'Aga Khan University Hospital (AKUH), Karachi, Pakistan', 'COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH', '50 patients in five study groups with 10 patients in each study group', 'hospitalised COVID-19 patients', 'Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus', 'COVID-19 positive patients']","['10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products', 'Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles', 'Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution', '10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc', 'hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage', '10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories', 'Neem extract (Azardirachta indica']","['reduction in the intra-oral viral load confirmed with real time quantitative PCR', 'intraoral viral load', 'salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0023646', 'cui_str': 'Lichen planus'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C2347335', 'cui_str': 'Azadirachta indica flower extract'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]",10.0,0.253668,Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients.,"[{'ForeName': 'Farhan Raza', 'Initials': 'FR', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Aga Khan University, Karachi, 74800, Pakistan. farhan.raza@aku.edu.'}, {'ForeName': 'Syed Murtaza Raza', 'Initials': 'SMR', 'LastName': 'Kazmi', 'Affiliation': 'Department of Surgery, Aga Khan University, Karachi, 74800, Pakistan.'}, {'ForeName': 'Najeeha Talat', 'Initials': 'NT', 'LastName': 'Iqbal', 'Affiliation': 'Department of Pediatrics & Child Health, Aga Khan University, Karachi, 74800, Pakistan.'}, {'ForeName': 'Junaid', 'Initials': 'J', 'LastName': 'Iqbal', 'Affiliation': 'Department of Pediatrics & Child Health, Aga Khan University, Karachi, 74800, Pakistan.'}, {'ForeName': 'Syed Tariq', 'Initials': 'ST', 'LastName': 'Ali', 'Affiliation': 'Department of Chemistry, University of Karachi, Karachi, 75271, Pakistan.'}, {'ForeName': 'Syed Akbar', 'Initials': 'SA', 'LastName': 'Abbas', 'Affiliation': 'Department of Surgery, Aga Khan University, Karachi, 74800, Pakistan.'}]",Trials,['10.1186/s13063-020-04634-2']
2508,32928328,Safety and Efficacy of CarbonCool Half-Body Vest for HAZMAT Decontamination Crews Wearing Personal Protective Equipment: A Pilot Study.,"BACKGROUND


Personal protective equipment (PPE) are essential for medical personnel responding to hazardous materials (HAZMAT) incidents. However, their impermeable design causes increased physiological strain and reduced thermoregulation, limiting work times and causing heat-related illnesses (HRI). Use of wearable cooling devices slow heat accumulation and have been shown to reduce thermal and cardiovascular strain in such situations.
METHODS


This was a prospective clinical evaluation to determine the tolerability and effectiveness of the CarbonCool cooling system - a half-body cooling vest - in participants undergoing a HAZMAT decontamination recertification. Physiological measurements (heart rate [HR], weight, temperature, and blood pressure) and participant feedback were obtained. The main outcome of interest was participants' tolerability of the cooling vest.
RESULTS


A total of 23 healthy participants were recruited, with 10 randomized to the intervention group and 13 in the control group. Mean age in the control and intervention group was 35.5 years old (SD = 7.8) and 30.0 years old (SD = 6.2), respectively. Qualitative feedback obtained from participants regarding safety, mobility, and cooling efficacy was largely positive. Difference of before-after temperature and HR was 0.3°C (SD = 0.8) and 11.5bpm (SD = 13.6) in the control group compared to 0.0°C (SD = 0.5) and 0.0bpm (SD = 6.4) for the intervention group.
CONCLUSION


This clinical evaluation showed that the CarbonCool cooling vest is safe and tolerable in participants wearing PPE. Further trials with sample size powered to detect physiological outcomes are needed to assess the effect of the cooling vest on a subject's endurance to heat stress.",2020,"Qualitative feedback obtained from participants regarding safety, mobility, and cooling efficacy was largely positive.","['23 healthy participants', 'Mean age in the control and intervention group was 35.5 years old (SD = 7.8) and 30.0 years old (SD = 6.2), respectively', 'participants wearing PPE', 'participants undergoing a HAZMAT decontamination recertification']","['cooling vest', 'CarbonCool cooling system - a half-body cooling vest ', 'CarbonCool cooling vest', 'CarbonCool', 'Half-Body Vest for HAZMAT Decontamination Crews', 'Personal protective equipment (PPE']","['Physiological measurements (heart rate [HR], weight, temperature, and blood pressure) and participant feedback', 'Safety and Efficacy', 'physiological strain and reduced thermoregulation, limiting work times and causing heat-related illnesses (HRI', 'tolerability of the cooling vest', 'tolerability and effectiveness', 'safety, mobility, and cooling efficacy']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0018626', 'cui_str': 'Hazardous Materials'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0412808', 'cui_str': 'Active cooling of patient'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0018626', 'cui_str': 'Hazardous Materials'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0005905', 'cui_str': 'Thermoregulation, function'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",23.0,0.0636664,"Qualitative feedback obtained from participants regarding safety, mobility, and cooling efficacy was largely positive.","[{'ForeName': 'Pamela Jia Min', 'Initials': 'PJM', 'LastName': 'Tay', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Zhi Xiong', 'Initials': 'ZX', 'LastName': 'Koh', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Health Services Research Centre, Singapore Health Services, Singapore.'}, {'ForeName': 'Mark Kwok Fai', 'Initials': 'MKF', 'LastName': 'Leong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore.'}]",Prehospital and disaster medicine,['10.1017/S1049023X20001144']
2509,32928502,Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial.,,2020,,[],['Botulinum Toxin'],['Poststroke Postural Sway'],[],"[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}]",,0.79864,,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bensoussan', 'Affiliation': 'Aix Marseille University, Pôle de Médecine Physique et de Réadaptation, Marseille, France.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Kerzoncuf', 'Affiliation': 'Aix Marseille University, Inst Neurosci Timone, APHM, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Viton', 'Affiliation': 'Aix Marseille University, Inst Neurosci Timone, APHM, CHU Timone, Physical and Rehabilitation Medicine Department, Marseille, France.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.031']
2510,32928503,Effectiveness of a self-management program for joint protection and physical activity in patients with rheumatoid arthritis: A randomized controlled trial.,"BACKGROUND


Rheumatoid arthritis is a chronic, systemic disease, which results in progressive destruction of the joints and a reduction in quality of life. Joint protection can minimize injuries that worsen arthritis and pain and certain activities can help patients control or reduce the symptoms of this chronic disease.
OBJECTIVES


To determine the effectiveness of a self-management program for joint protection and physical activity for patients with rheumatoid arthritis based on self-efficacy theory.
DESIGN


A two-arm (experimental vs control) randomized trial.
PARTICIPANTS


Adult patients with rheumatoid arthritis were recruited from rheumatology departments of a medical center in Northern Taiwan. A total of 224 patients met the inclusion criteria and agreed to participate in the study.
METHODS


Eligible participants with rheumatoid arthritis were randomly assigned to either an 8-week program in self-management of joint protection and physical activity with nursing support (intervention group, n = 112) or standard care for rheumatology (control group, n = 112). Outcome variables were assessed at baseline and 2-, 3-, and 6-months after commencement of the intervention, which included measures of disease activity, and self-assessments for self-efficacy, quality of life, and self-management behaviors. Differences in outcome variables over time between the groups were analyzed with generalized estimating equations; the level of significance was set at p < 05.
RESULTS


The mean age of participants was 58.8 years, duration of the rheumatoid arthritis was 10 years, and most participants (86%) were female. Characteristics and assessment variables did not differ between the two groups at baseline. When compared with the control group at 6 months following initiation of the self-management program, participants in the intervention group demonstrated significantly greater improvement in physical functioning (B = 4.08, p < 05), self-efficacy of pain (B = 4.89, p < .05), and self-management behaviors (B = 4.65, p < 05).
CONCLUSIONS


A self-management program based on self-efficacy theory that focused on joint protection and physical activities resulted in significant improvements in physical functioning, self-efficacy, and self-management behaviors 6 months following commencement of the intervention. Nurses provided individualized evaluations and support, which may have made it easier for participants to learn and perform the activities. After commencement of participation in the intervention, no improvements were seen until 6 months of participation. This delay may suggest patients with chronic disease may need a longer duration of self-management training and increased follow-up time to incorporate lifestyle changes. Future studies measuring long-term outcomes are suggested.",2020,"When compared with the control group at 6 months following initiation of the self-management program, participants in the intervention group demonstrated significantly greater improvement in physical functioning (B = 4.08, p < 05), self-efficacy of pain (B = 4.89, p < .05), and self-management behaviors (B = 4.65, p < 05).
","['patients with rheumatoid arthritis based on self-efficacy theory', 'patients with chronic disease', '224 patients met the inclusion criteria and agreed to participate in the study', 'patients with rheumatoid arthritis', 'Adult patients with rheumatoid arthritis were recruited from rheumatology departments of a medical center in Northern Taiwan', 'Eligible participants with rheumatoid arthritis', 'The mean age of participants was 58.8 years, duration of the rheumatoid arthritis was 10 years, and most participants (86%) were female']","['self-management program', '8-week program in self-management of joint protection and physical activity with nursing support (intervention group, n\xa0=\xa0112) or standard care for rheumatology (control group, n\xa0=\xa0112']","['self-management behaviors', 'joint protection and physical activity', 'self-efficacy of pain', 'physical functioning, self-efficacy, and self-management behaviors', 'disease activity, and self-assessments for self-efficacy, quality of life, and self-management behaviors', 'physical functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587479', 'cui_str': 'Rheumatology department'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",224.0,0.0428538,"When compared with the control group at 6 months following initiation of the self-management program, participants in the intervention group demonstrated significantly greater improvement in physical functioning (B = 4.08, p < 05), self-efficacy of pain (B = 4.89, p < .05), and self-management behaviors (B = 4.65, p < 05).
","[{'ForeName': 'Jung-Hua', 'Initials': 'JH', 'LastName': 'Shao', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, Wenhua 1st Road, Taoyuan City, Taiwan. No. 259, Wenhua 1st Rd., Guishan Dist., Taoyuan City 333, Taiwan; Department of Joint Reconstruction, Chang Gung Memorial Hospital, Linkou. No. 5, Fu-Hsin St., Guishan Dist., Taoyuan City 333, Taiwan. Electronic address: shao@mail.cgu.edu.tw.'}, {'ForeName': 'Kuang-Hui', 'Initials': 'KH', 'LastName': 'Yu', 'Affiliation': 'Department of Rheumatology, Allergy, and Immunology, Chang Gung Memorial Hospital, Taiwan. No.5, Fu-Hsin St., Guishan Dist., Taoyuan City 333, Taiwan; Chang Gung University, Taiwan. No. 259, Wenhua 1st Rd., Guishan Dist., Taoyuan City 333, Taiwan. Electronic address: gout@cgmh.org.tw.'}, {'ForeName': 'Su-Hui', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology, Allergy, and Immunology, Chang Gung Memorial Hospital, Taiwan. No.5, Fu-Hsin St., Guishan Dist., Taoyuan City 333, Taiwan; School of Nursing, Chang Gung University of Science and Technology, Taiwan. No. 261, Wenhua 1st Rd., Guishan Dist., Taoyuan City 33303, Taiwan. Electronic address: sophee@mail.cgust.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103752']
2511,32871870,Celiac disease serology and gut microbiome following protein pump inhibitor treatment.,"BACKGROUND


Celiac disease is an autoimmune enteropathy characterized by an aberrant immune response to ingested gluten in genetically predisposed individuals. Studies have pointed to a rising prevalence of celiac disease in recent decades. Changes in diet and use of medication that may impact the gut microbiome have been suggested as potential contributors. Exposure to protein pump inhibitors (PPIs) was recently found to be associated with an increased risk for subsequent diagnosis of celiac disease. We aimed to investigate potential mechanisms for this link by examining the relationship between PPI use and gluten-related immune responses in the context of changes in gut microbiome.
METHODS


We performed a post hoc analysis of blood and fecal samples from a recent randomized trial in order to assess the potential association between PPI use and development of celiac disease serology in conjunction with alterations in gastrointestinal microbial composition. The study included 12 healthy participants who were administered a PPI (Omeprazole; 40 mg twice daily) for 4 or 8 weeks.
RESULTS


The analysis did not reveal an overall significant change in levels of serologic markers of celiac disease for the study cohort in response to PPI treatment. However, one individual developed a marked increase in the celiac disease-specific autoantibody response to transglutaminase 2 in conjunction with enhanced immune reactivity to gluten during the trial. Genotyping revealed positivity for the celiac disease-associated HLA-DQ2 and -DQ8 alleles. Furthermore, the observed elevation in antibody responses was closely associated with a sharp increase in fecal abundance of bacteria of the order Actinomycetales.
CONCLUSIONS


The results of this exploratory analysis support further investigation of molecular mechanisms involved in the contribution of PPIs to celiac disease risk through the potential enhancement of gluten immunopathology and changes in gut microbial population.",2020,The analysis did not reveal an overall significant change in levels of serologic markers of celiac disease for the study cohort in response to PPI treatment.,['12 healthy participants who were administered a'],"['protein pump inhibitors (PPIs', 'PPI (Omeprazole']","['levels of serologic markers of celiac disease', 'celiac disease-specific autoantibody response', 'fecal abundance of bacteria of the order Actinomycetales']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0235914', 'cui_str': 'Autoantibody response'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0001254', 'cui_str': 'Actinomycetales'}]",12.0,0.0353551,The analysis did not reveal an overall significant change in levels of serologic markers of celiac disease for the study cohort in response to PPI treatment.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jang', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Julian A', 'Initials': 'JA', 'LastName': 'Abrams', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Peter H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Freedberg', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Alaedini', 'Affiliation': 'Department of Medicine.'}]",Medicine,['10.1097/MD.0000000000021488']
2512,32877582,Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis.,"BACKGROUND


Sodium phenylbutyrate and taurursodiol have been found to reduce neuronal death in experimental models. The efficacy and safety of a combination of the two compounds in persons with amyotrophic lateral sclerosis (ALS) are not known.
METHODS


In this multicenter, randomized, double-blind trial, we enrolled participants with definite ALS who had had an onset of symptoms within the previous 18 months. Participants were randomly assigned in a 2:1 ratio to receive sodium phenylbutyrate-taurursodiol (3 g of sodium phenylbutyrate and 1 g of taurursodiol, administered once a day for 3 weeks and then twice a day) or placebo. The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks. Secondary outcomes were the rates of decline in isometric muscle strength, plasma phosphorylated axonal neurofilament H subunit levels, and the slow vital capacity; the time to death, tracheostomy, or permanent ventilation; and the time to death, tracheostomy, permanent ventilation, or hospitalization.
RESULTS


A total of 177 persons with ALS were screened for eligibility, and 137 were randomly assigned to receive sodium phenylbutyrate-taurursodiol (89 participants) or placebo (48 participants). In a modified intention-to-treat analysis, the mean rate of change in the ALSFRS-R score was -1.24 points per month with the active drug and -1.66 points per month with placebo (difference, 0.42 points per month; 95% confidence interval, 0.03 to 0.81; P = 0.03). Secondary outcomes did not differ significantly between the two groups. Adverse events with the active drug were mainly gastrointestinal.
CONCLUSIONS


Sodium phenylbutyrate-taurursodiol resulted in slower functional decline than placebo as measured by the ALSFRS-R score over a period of 24 weeks. Secondary outcomes were not significantly different between the two groups. Longer and larger trials are necessary to evaluate the efficacy and safety of sodium phenylbutyrate-taurursodiol in persons with ALS. (Funded by Amylyx Pharmaceuticals and others; CENTAUR ClinicalTrials.gov number, NCT03127514.).",2020,"The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks.","['Amyotrophic Lateral Sclerosis', 'persons with ALS', '177 persons with ALS were screened for eligibility, and 137', 'persons with amyotrophic lateral sclerosis (ALS', 'enrolled participants with definite ALS who had had an onset of symptoms within the previous 18 months']","['sodium phenylbutyrate-taurursodiol (3 g of sodium phenylbutyrate and 1 g of taurursodiol', 'sodium phenylbutyrate-taurursodiol', 'placebo', 'Sodium Phenylbutyrate-Taurursodiol']","['rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range', 'mean rate of change in the ALSFRS-R score', 'slower functional decline', 'efficacy and safety', 'Adverse events', 'rates of decline in isometric muscle strength, plasma phosphorylated axonal neurofilament H subunit levels, and the slow vital capacity; the time to death, tracheostomy, or permanent ventilation; and the time to death, tracheostomy, permanent ventilation, or hospitalization', 'ALSFRS-R score', 'neuronal death']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4305309', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised score'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1505576', 'cui_str': 'NEFH protein, human'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}]",177.0,0.608843,"The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks.","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hendrix', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Elliott', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Maiser', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Caress', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Owegi', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Quick', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Heiman-Patterson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kasarskis', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Jenkins', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Scelsa', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Fournier', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Glass', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Johnson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pattee', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Andres', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dagostino', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Dickson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Ellison', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Hendrix', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Gale', 'Initials': 'G', 'LastName': 'Kittle', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ostrow', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randall', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sherman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tustison', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Prasha', 'Initials': 'P', 'LastName': 'Vigneswaran', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Klee', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Rudolph E', 'Initials': 'RE', 'LastName': 'Tanzi', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gilbert', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Yeramian', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}]",The New England journal of medicine,['10.1056/NEJMoa1916945']
2513,32877599,Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma.,"BACKGROUND


In the previously reported primary analysis of this phase 3 trial, 12 months of adjuvant dabrafenib plus trametinib resulted in significantly longer relapse-free survival than placebo in patients with resected stage III melanoma with  BRAF  V600E or V600K mutations. To confirm the stability of the relapse-free survival benefit, longer-term data were needed.
METHODS


We randomly assigned 870 patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations to receive 12 months of oral dabrafenib (at a dose of 150 mg twice daily) plus trametinib (2 mg once daily) or two matched placebos. The primary end point was relapse-free survival. Here, we report 5-year results for relapse-free survival and survival without distant metastasis as the site of the first relapse. Overall survival was not analyzed, since the required number of events to trigger the final overall survival analysis had not been reached.
RESULTS


The minimum duration of follow-up was 59 months (median patient follow-up, 60 months for dabrafenib plus trametinib and 58 months for placebo). At 5 years, the percentage of patients who were alive without relapse was 52% (95% confidence interval [CI], 48 to 58) with dabrafenib plus trametinib and 36% (95% CI, 32 to 41) with placebo (hazard ratio for relapse or death, 0.51; 95% CI, 0.42 to 0.61). The percentage of patients who were alive without distant metastasis was 65% (95% CI, 61 to 71) with dabrafenib plus trametinib and 54% (95% CI, 49 to 60) with placebo (hazard ratio for distant metastasis or death, 0.55; 95% CI, 0.44 to 0.70). No clinically meaningful between-group difference in the incidence or severity of serious adverse events was reported during the follow-up period.
CONCLUSIONS


In the 5-year follow-up of a phase 3 trial involving patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations, 12 months of adjuvant therapy with dabrafenib plus trametinib resulted in a longer duration of survival without relapse or distant metastasis than placebo with no apparent long-term toxic effects. (Funded by GlaxoSmithKline and Novartis; COMBI-AD ClinicalTrials.gov number, NCT01682083; EudraCT number, 2012-001266-15.).",2020,"No clinically meaningful between-group difference in the incidence or severity of serious adverse events was reported during the follow-up period.
","['870 patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations to receive 12 months of', 'patients with resected stage III melanoma with  BRAF  V600E or V600K mutations', 'Stage III Melanoma', 'patients who had resected stage III melanoma with  BRAF  V600E or V600K mutations, 12 months of adjuvant therapy with']","['oral dabrafenib (at a dose of 150 mg twice daily) plus trametinib (2 mg once daily) or two matched placebos', 'dabrafenib plus trametinib', 'placebo']","['Overall survival', 'alive without relapse', 'relapse-free survival', 'incidence or severity of serious adverse events', 'longer duration of survival without relapse or distant metastasis', 'alive without distant metastasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C1269798', 'cui_str': 'pM category'}]",870.0,0.76883,"No clinically meaningful between-group difference in the incidence or severity of serious adverse events was reported during the follow-up period.
","[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santinami', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion Sileni', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Kohinoor', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) - all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute-IRCCS, Padua (V.C.S.) - all in Italy; Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), Alfred Hospital, Melbourne, VIC (A. Haydon), and Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney (G.V.L.) - all in Australia; the Melanoma Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (J.M.K.); Royal Marsden NHS Foundation Trust, London (J.L.), and the Northern Centre for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne (R.P.) - both in the United Kingdom; Oslo University Hospital, the Norwegian Radium Hospital, Oslo (M.N.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint-André, Bordeaux (C.D.), Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Université de Lille, INSERM Unité 1189, Lille (L.M.), and the Medical Oncology Department, Centre Eugène Marquis, Rennes (T.L.) - all in France; Ella Lemelbaum Institute for Immuno-Oncology and Melanoma, Sheba Medical Center, Tel Hashomer, and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv - both in Israel (J.S.); Novartis Healthcare, Hyderabad, India (K.D.); and Novartis Pharmaceuticals, East Hanover, NJ (E.G., M.T.).'}]",The New England journal of medicine,['10.1056/NEJMoa2005493']
2514,32928851,Rhythm and Movement for Self-Regulation (RAMSR) intervention for preschool self-regulation development in disadvantaged communities: a clustered randomised controlled trial study protocol.,"INTRODUCTION


Self-regulation (the ability to regulate emotion, attention, cognition and behaviour) is an integral part of early learning competence in the years prior to school. Self-regulation skills are critical to ongoing learning behaviours, achievement and well-being. Emerging neurological evidence suggests coordinated music and movement participation could support self-regulation development for all children. A pilot study in 2016 introduced a coordinated music and movement programme designed to boost self-regulation skills in children in disadvantaged communities, delivered by visiting specialists, with promising findings. The intervention is based on the neuroscience of beat synchronisation, rhythmic entrainment and the cognitive benefits of music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR). This study builds on the pilot by training regular teachers to deliver RAMSR in their classrooms (rather than visiting specialists). The study aims to establish the effectiveness of RAMSR, which is designed to translate the cognitive benefits that accrue from rhythm participation to address self-regulation for children who do not typically access high-quality music programmes.
METHODS AND ANALYSIS


We will recruit 237 children from up to eight kindergartens in low socioeconomic areas.
INTERVENTION


teachers will be trained to deliver the RAMSR intervention during group time in kindergartens, daily for 8 weeks.
CONTROL


usual practice kindergarten programme.
FOLLOW-UP


end of intervention using child assessments and teacher report; 12 months postbaseline using school teacher reports following school transition. Primary outcomes: executive function and self-regulation.
SECONDARY OUTCOMES


school readiness; visual-motor integration; teacher-reported behaviour problems, school transition and academic competency; teacher knowledge, confidence, practice and attitudes related to self-regulation, rhythm and movement; fidelity of intervention implementation.
ETHICS AND DISSEMINATION


Queensland University of Technology Human Research Ethics Committee, approval 1900000566. Findings dissemination: in-field workshops to service providers, conference presentations, journal and professional publications.
TRIAL REGISTRATION NUMBER


ACTRN12619001342101; Pre-results (30 September 2019).",2020,"The intervention is based on the neuroscience of beat synchronisation, rhythmic entrainment and the cognitive benefits of music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR).","['disadvantaged communities', 'children who do not typically access high-quality music programmes', '237 children from up to eight kindergartens in low socioeconomic areas', 'children in disadvantaged communities, delivered by visiting specialists, with promising findings']","['RAMSR intervention', 'music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR', 'RAMSR', 'Rhythm and Movement for Self-Regulation (RAMSR) intervention', 'coordinated music and movement programme designed to boost self-regulation skills']","['visual-motor integration', 'behaviour problems, school transition and academic competency; teacher knowledge, confidence, practice and attitudes related to self-regulation, rhythm and movement; fidelity', 'executive function and self-regulation']","[{'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",237.0,0.03755,"The intervention is based on the neuroscience of beat synchronisation, rhythmic entrainment and the cognitive benefits of music therapy and music education-and is called Rhythm and Movement for Self-Regulation (RAMSR).","[{'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Williams', 'Affiliation': 'School of Early Childhood & Inclusive Education, Faculty of Education, Queensland University of Technology, Brisbane, Queensland, Australia k15.williams@qut.edu.au.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Savage', 'Affiliation': 'School of Early Childhood & Inclusive Education, Faculty of Education, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Eager', 'Affiliation': 'School of Early Childhood & Inclusive Education, Faculty of Education, Queensland University of Technology, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-036392']
2515,32928863,"Beta-alanine supplementation in patients with COPD receiving non-linear periodised exercise training or neuromuscular electrical stimulation: protocol of two randomised, double-blind, placebo-controlled trials.","INTRODUCTION


Exercise intolerance is common in patients with chronic obstructive pulmonary disease (COPD) and, although multifactorial, it is largely caused by lower-limb muscle dysfunction. Research has shown that patients with severe to very severe COPD have significantly lower levels of muscle carnosine, which acts as a pH buffer and antioxidant. Beta-alanine (BA) supplementation has been shown to consistently elevate muscle carnosine in a variety of populations and may therefore improve exercise tolerance and lower-limb muscle function. The primary objective of the current studies is to assess the beneficial effects of BA supplementation in enhancing exercise tolerance on top of two types of exercise training (non-linear periodised exercise (NLPE) training or neuromuscular electrical stimulation (NMES)) in patients with COPD.
METHODS AND ANALYSIS


Two randomised, double-blind, placebo-controlled trials have been designed. Patients will routinely receive either NLPE (BASE-TRAIN trial) or NMES (BASE-ELECTRIC trial) as part of standard exercise-based care during their 8-to-10 week pulmonary rehabilitation (PR) programme. A total of 222 patients with COPD (2×77 = 154 patients in the BASE-TRAIN trial and 2×34 = 68 patients in the BASE-ELECTRIC trial) will be recruited from two specialised PR centres in The Netherlands. For study purposes, patients will receive 3.2 g of oral BA supplementation or placebo per day. Exercise tolerance is the primary outcome, which will be assessed using the endurance shuttle walk test (BASE-TRAIN) or the constant work rate cycle test (BASE-ELECTRIC). Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured.
ETHICS AND DISSEMINATION


Both trials were approved by CMO Regio Arnhem-Nijmegen, The Netherlands (NL70781.091.19. and NL68757.091.19).
TRIAL REGISTRATION NUMBER


NTR8427 (BASE-TRAIN) and NTR8419 (BASE-ELECTRIC).",2020,"Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured.
","['222 patients with COPD (2×77 = 154 patients in the BASE-TRAIN trial and 2×34 = 68 patients in the BASE-ELECTRIC trial) will be recruited from two specialised PR centres in The Netherlands', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'patients with severe to very severe COPD', 'patients with COPD receiving non-linear periodised exercise training or neuromuscular electrical stimulation']","['BA supplementation', 'Beta-alanine (BA) supplementation', 'NMES', 'NLPE', 'standard exercise-based care during their 8-to-10 week pulmonary rehabilitation (PR) programme', 'placebo', 'oral BA supplementation or placebo', 'Beta-alanine supplementation', 'exercise training (non-linear periodised exercise (NLPE) training or neuromuscular electrical stimulation (NMES']","['Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1446110', 'cui_str': 'Urine beta-alanine measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",222.0,0.592063,"Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Meys', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands roymeys@ciro-horn.nl.'}, {'ForeName': 'Anouk A F', 'Initials': 'AAF', 'LastName': 'Stoffels', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'de Brandt', 'Affiliation': 'Reval Rehabilitation Research, Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, DIepenbeek, Belgium.'}, {'ForeName': 'Hieronymus W H', 'Initials': 'HWH', 'LastName': 'van Hees', 'Affiliation': 'Department of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The Netherlands.'}, {'ForeName': 'Frits M E', 'Initials': 'FME', 'LastName': 'Franssen', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Maurice J H', 'Initials': 'MJH', 'LastName': 'Sillen', 'Affiliation': 'Department of Physiotherapy, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Burtin', 'Affiliation': 'Reval Rehabilitation Research, Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, DIepenbeek, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Klijn', 'Affiliation': 'Department of Pulmonology, Merem Pulmonary Rehabilitation Centre, Hilversum, The Netherlands.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Bij de Vaate', 'Affiliation': 'Department of Pulmonology, Merem Pulmonary Rehabilitation Centre, Hilversum, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'van den Borst', 'Affiliation': 'Department of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The Netherlands.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Otker', 'Affiliation': 'Patient Advisory Council, Lung Foundation Netherlands, Amersfoort, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Donkers', 'Affiliation': 'Client Council, CIRO, Horn, The Netherlands.'}, {'ForeName': 'Florence N', 'Initials': 'FN', 'LastName': 'Schleich', 'Affiliation': 'Department of Respiratory Medicine, CHU Sart-Tilman Liege, GIGA I3, Liege, Belgium.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Hayot', 'Affiliation': 'PhyMedExp, INSERM - CNRS, University of Montpellier - Montpellier CHU, Montpellier, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pomiès', 'Affiliation': 'PhyMedExp, INSERM - CNRS, University of Montpellier - Montpellier CHU, Montpellier, France.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Everaert', 'Affiliation': 'Department of Movement and Sport Sciences, University Ghent, Ghent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Derave', 'Affiliation': 'Department of Movement and Sport Sciences, University Ghent, Ghent, Belgium.'}, {'ForeName': 'Martijn A', 'Initials': 'MA', 'LastName': 'Spruit', 'Affiliation': 'Department of Research and Development, CIRO, Horn, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038836']
2516,32928937,Effect of combined facial exercise with botulinum toxin A on health-related quality of life in Thai adults with hemifacial spasm: a randomised controlled pilot cross-over trial.,,2020,,['Thai adults with hemifacial spasm'],['combined facial exercise with botulinum toxin A'],['health-related quality of life'],"[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0278152', 'cui_str': 'Hemifacial spasm'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454333', 'cui_str': 'Facial exercises'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.118923,,"[{'ForeName': 'Yuvadee', 'Initials': 'Y', 'LastName': 'Pitakpatapee', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pannathat', 'Initials': 'P', 'LastName': 'Soontrapa', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Arpakorn', 'Initials': 'A', 'LastName': 'Suengtaworn', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jindapa', 'Initials': 'J', 'LastName': 'Srikajon', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tanita', 'Initials': 'T', 'LastName': 'Sangpeamsook', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chulalak', 'Initials': 'C', 'LastName': 'Komoltri', 'Affiliation': 'Research Group and Research Network Division, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Prachaya', 'Initials': 'P', 'LastName': 'Srivanitchapoom', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand cloundbuffy@gmail.com.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-323604']
2517,32928957,Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies.,"OBJECTIVE


To evaluate the incidence and risk factors for diabetic ketoacidosis (DKA) and related adverse events (AEs) in adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin.
RESEARCH DESIGN AND METHODS


Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in β-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L. The patients were administered placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily.
RESULTS


A total of 191 ketosis-related AEs were reported, and 98 underwent adjudication. Of these, 37 events (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg. No patient died of a DKA event. From a baseline BHB of ∼0.13 mmol/L, sotagliflozin treatment led to a small median increase over 52 weeks (≤0.05 mmol/L at all time points). Of sotagliflozin-treated patients, approximately 47% and 7% had ≥1 BHB measurement >0.6 mmol/L and >1.5 mmol/L, respectively (vs. 20% and 2%, respectively, of placebo-treated patients). Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
CONCLUSIONS


In patients with type 1 diabetes, confirmed DKA incidence increased when sotagliflozin was added to insulin compared with insulin alone. A lower incidence of DKA was observed following the implementation of an enhanced risk mitigation plan, suggesting that this risk can be managed with patient education.",2020,"Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
","['Adults With Type 1 Diabetes', 'adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin', 'Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in β-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L', '37 events (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for']","['placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg', 'placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily', 'Sotagliflozin', 'sotagliflozin']","['DKA incidence', 'Diabetic Ketoacidosis', 'annualized DKA incidence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.15226,"Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus preimplementation in both the sotagliflozin 200 and 400 mg groups.
","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, CA annepete@med.usc.edu.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center at Dallas, Dallas, TX.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Kinder Krakenhaus auf der Bult, Diabetes Zentrum für Kinder and Jugendliche, Hannover, Germany.'}, {'ForeName': 'Jake A', 'Initials': 'JA', 'LastName': 'Kushner', 'Affiliation': 'McNair Interests, Houston, TX.'}, {'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants Research Center, Rockville, MD.'}, {'ForeName': 'Ketan', 'Initials': 'K', 'LastName': 'Dhatariya', 'Affiliation': 'Norfolk and Norwich University Hospitals National Health Service Foundation Trust, Norwich, U.K.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sawhney', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, TX.'}]",Diabetes care,['10.2337/dc20-0924']
2518,32929107,Prolonged bedrest reduces plasma high-density lipoprotein levels linked to markedly suppressed cholesterol efflux capacity.,"Recent observations strongly connect high-density lipoproteins (HDL) function and levels with coronary heart disease outcomes and risk for infections and sepsis. To date, our knowledge of factors determining this connection is still very limited. The immobility associated with prolonged bedrest is detrimental to health, affecting several systems, including the cardiovascular, pulmonary, gastrointestinal, musculoskeletal and urinary. Effects of prolonged bedrest on the composition and functional properties of HDL remain elusive. We evaluated metrics of HDL composition and function in healthy male volunteers participating in a randomized, crossover head-down bedrest study. We observed that HDL cholesterol efflux capacity was profoundly decreased during bedrest, mediated by a bedrest associated reduction in plasma levels of HDL-cholesterol and major apolipoproteins (apo) apoA-I and apoA-II. Paraoxonase activity, plasma anti-oxidative capacity and the activities of lecithin-cholesterol acyltransferase and cholesteryl ester transfer protein were not affected. No change was observed in the content of HDL-associated serum amyloid A, a sensitive marker of inflammation. Resistive vibration exercise countermeasure during bedrest did not correct impaired cholesterol efflux capacity and only tended to increase arylesterase activity of HDL-associated paraoxonase. In conclusion, prolonged bedrest reduces plasma HDL levels linked to markedly suppressed HDL cholesterol efflux capacity. Resistive vibration exercise during bedrest did not correct HDL levels and impaired cholesterol efflux capacity.",2020,Resistive vibration exercise countermeasure during bedrest did not correct impaired cholesterol efflux capacity and only tended to increase arylesterase activity of HDL-associated paraoxonase.,"['healthy male volunteers participating in a randomized, crossover head-down bedrest study']","['Resistive vibration exercise', 'Resistive vibration exercise countermeasure']","['plasma HDL levels', 'Paraoxonase activity, plasma anti-oxidative capacity and the activities of lecithin-cholesterol acyltransferase and cholesteryl ester transfer protein', 'plasma levels of HDL-cholesterol and major apolipoproteins (apo', 'HDL cholesterol efflux capacity', 'content of HDL-associated serum', 'cholesterol efflux capacity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0052451', 'cui_str': 'Arylesterase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023194', 'cui_str': 'Phosphatidylcholine-sterol acyltransferase'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0172899,Resistive vibration exercise countermeasure during bedrest did not correct impaired cholesterol efflux capacity and only tended to increase arylesterase activity of HDL-associated paraoxonase.,"[{'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Trakaki', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Scharnagl', 'Affiliation': 'Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Trieb', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holzer', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hinghofer-Szalkay', 'Affiliation': 'Division of Physiology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Neue Stiftingtalstrasse 6/D-5, 8010, Graz, Austria.'}, {'ForeName': 'Nandu', 'Initials': 'N', 'LastName': 'Goswami', 'Affiliation': 'Division of Physiology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Neue Stiftingtalstrasse 6/D-5, 8010, Graz, Austria. nandu.goswami@medunigraz.at.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Marsche', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center for Vascular Biology, Immunology and Inflammation, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria. gunther.marsche@medunigraz.at.'}]",Scientific reports,['10.1038/s41598-020-71921-y']
2519,31791637,Cardiometabolic risk factors and Framingham Risk Score in severely obese patients: Baseline data from DieTBra trial.,"BACKGROUND AND AIMS


Little is known about differences of cardiometabolic risk factors (CMRF) and the function of Framingham Risk Score (FRS) within severe obesity, thus we aimed to study not only CMRF and FRS, but to determine significant differences between BMI ranges within severe obesity.
METHODS AND RESULTS


In this baseline analysis of the Traditional Brazilian Diet (DieTBra) Trial, several CMRF were assessed in 150 adult patients in two BMI ranges: 35.0-44.9 kg/m 2  (n = 76) and ≥45 kg/m 2  (n = 74). Body composition was evaluated by multifrequency bioelectrical impedance analysis to measure the percent of body fat, visceral fat area and waist circumference. Pearson's Chi-squared, Fisher's Exact, Student's t-test, and Mann-Whitney's test were used in the statistical analysis with a 5% significance level. Hypertension, C-reactive protein, systolic and diastolic blood pressure and positive family history for heart diseases were more prevalent in BMI ≥45.0 kg/m 2  (p < 0.05). Mean values of waist circumference, body fat %, visceral fat area, and systolic blood pressure were significantly higher in patients with BMI ≥45.0 kg/m 2 . Regarding the function of FRS, 40.0% of the patients were at high risk. No differences were found for diabetes, lifestyle, lipid parameters, and FRS within different BMI ranges, except for dyslipidemia, significantly higher among participants with BMI 35.0-44.9 kg/m 2 .
CONCLUSION


BMI >45 kg/m 2  was associated with higher prevalence of hypertension, systolic and diastolic blood pressure, C-reactive protein, waist circumference, body fat % and family history of heart diseases, enhancing the risk for the occurrence of cardiovascular diseases.",2020,"Mean values of waist circumference, body fat %, visceral fat area, and systolic blood pressure were significantly higher in patients with BMI ≥45.0 kg/m 2 .","['severely obese patients', '150 adult patients in two BMI ranges: 35.0-44.9\xa0kg/m 2  (n\xa0=\xa076) and ≥45\xa0kg/m 2  (n\xa0=\xa074']",[],"['hypertension, systolic and diastolic blood pressure, C-reactive protein, waist circumference, body fat % and family history of heart diseases', 'diabetes, lifestyle, lipid parameters, and FRS within different BMI ranges, except for dyslipidemia', 'Mean values of waist circumference, body fat %, visceral fat area, and systolic blood pressure', 'Cardiometabolic risk factors and Framingham Risk Score', 'Hypertension, C-reactive protein, systolic and diastolic blood pressure and positive family history for heart diseases', 'Body composition']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",150.0,0.0448734,"Mean values of waist circumference, body fat %, visceral fat area, and systolic blood pressure were significantly higher in patients with BMI ≥45.0 kg/m 2 .","[{'ForeName': 'Annelisa S A C', 'Initials': 'ASAC', 'LastName': 'Santos', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Brazil. Electronic address: annelisa.nut@gmail.com.'}, {'ForeName': 'Ana Paula S', 'Initials': 'APS', 'LastName': 'Rodrigues', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Brazil.'}, {'ForeName': 'Lorena P S', 'Initials': 'LPS', 'LastName': 'Rosa', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Brazil.'}, {'ForeName': 'Nizal', 'Initials': 'N', 'LastName': 'Sarrafzadegan', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran; School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Erika A', 'Initials': 'EA', 'LastName': 'Silveira', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Goiás, Brazil.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.10.010']
2520,31808709,Putative Antidepressant Effect of Chamomile ( Matricaria chamomilla  L.) Oral Extract in Subjects with Comorbid Generalized Anxiety Disorder and Depression.,"Objectives:  This exploratory analysis examined the putative antidepressant effect of  Matricaria chamomilla  L. (chamomile) extract in subjects with generalized anxiety disorder (GAD) with or without comorbid depression. It was hypothesized that chamomile extract would demonstrate similar anxiolytic activity in both subgroups, but superior antidepressant activity in GAD subjects with comorbid depression.  Design:  As part of a randomized double-blind placebo-controlled trial of chamomile extract for relapse prevention of GAD, 179 subjects received initial therapy with open-label chamomile extract 1500 mg daily for 8 weeks. Linear mixed-effect models were used to identify clinically meaningful changes in anxiety and depression symptoms between diagnostic subgroups.  Settings/Location:  The study took place at the University of Pennsylvania in Philadelphia, PA.  Subjects:  Subjects were ≥18 years old with a primary DSM IV-TR diagnosis of GAD. They were subcategorized into two diagnostic groups: GAD without comorbid depression ( n  = 100) and GAD with comorbid depression ( n  = 79).  Interventions:  Open-label chamomile extract 1500 mg was given daily for 8 weeks.  Outcome measures:  Generalized anxiety disorder (GAD-7), Hamilton rating scale for anxiety, Beck anxiety inventory, Hamilton rating scale for depression (HRSD), the six-item core HRSD (items 1, 2, 3, 7, 8, and 13), and the Beck depression inventory (BDI).  Results:  The authors observed similar anxiolytic effects over time in both diagnostic subgroups. However, there was a greater reduction in HRSD core symptom scores ( p  < 0.023), and a trend level reduction in HRSD total scores ( p  = 0.14) and in BPI total scores ( p  = 0.060) in subjects with comorbid depression.  Conclusions:   M. chamomilla  L. may produce clinically meaningful antidepressant effects in addition to its anxiolytic activity in subjects with GAD and comorbid depression. Future controlled trials in subjects with primary major depressive disorder are needed to validate this preliminary observation.",2020,"However, there was a greater reduction in HRSD core symptom scores ( p  < 0.023), and a trend level reduction in HRSD total scores ( p  = 0.14) and in BPI total scores ( p  = 0.060) in subjects with comorbid depression.  ","['University of Pennsylvania in Philadelphia, PA', 'subjects with primary major depressive disorder', 'subjects with generalized anxiety disorder (GAD) with or without comorbid depression', 'They were subcategorized into two diagnostic groups: GAD without comorbid depression ( n \u2009=\u2009100) and GAD with comorbid depression ( n \u2009=\u200979', 'subjects with GAD and comorbid depression', '179 subjects received', 'GAD subjects with comorbid depression', 'Subjects:  Subjects were ≥18 years old with a primary DSM IV-TR diagnosis of GAD', 'Subjects with Comorbid Generalized Anxiety Disorder and Depression']","['Oral Extract', 'Chamomile ( Matricaria chamomilla  L', 'chamomile extract', 'placebo', 'Matricaria chamomilla  L. (chamomile) extract', 'initial therapy with open-label chamomile extract']","['anxiolytic effects', 'HRSD core symptom scores', 'anxiolytic activity', 'anxiety and depression symptoms', 'HRSD total scores', 'BPI total scores', 'Generalized anxiety disorder (GAD-7), Hamilton rating scale for anxiety, Beck anxiety inventory, Hamilton rating scale for depression (HRSD), the six-item core HRSD (items 1, 2, 3, 7, 8, and 13), and the Beck depression inventory (BDI']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0939806', 'cui_str': 'Matricaria recutita extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}]",,0.0188093,"However, there was a greater reduction in HRSD core symptom scores ( p  < 0.023), and a trend level reduction in HRSD total scores ( p  = 0.14) and in BPI total scores ( p  = 0.060) in subjects with comorbid depression.  ","[{'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Amsterdam', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Qing S', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sharon X', 'Initials': 'SX', 'LastName': 'Xie', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0252']
2521,31910989,Teaching in the operating room: A risk for surgical site infections?,"BACKGROUND/AIM


To investigate whether teaching procedures and surgical experience are associated with surgical site infection (SSI) rates.
METHODS


This prospective cohort study of patients undergoing general, orthopedic trauma and vascular surgery procedures was done between 2012 and 2015 at two tertiary care hospitals in Switzerland/Europe.
RESULTS


Out of a total of 4560 patients/surgeries, 1403 (30.8%) were classified as teaching operations. The overall SSI rate was 5.1% (n = 233). Teaching operations (OR 0.78, 95% CI 0.57-1.07, p = 0.120), junior surgeons (OR 0.80, 95% CI 0.55-1.15, p = 0.229) and surgical experience (OR 0.997, 95% CI 0.982-1.012, p = 0.676) were overall not independently associated with the odds of SSI. However, for surgeons' seniority and experience, these associations depended on the duration of surgery.
CONCLUSIONS


In procedures of shorter and medium duration, teaching procedures and junior as well as less experienced surgeons are not independently associated with increased odds of SSI.",2020,"Teaching operations (OR 0.78, 95% CI 0.57-1.07, p = 0.120), junior surgeons (OR 0.80, 95% CI 0.55-1.15, p = 0.229) and surgical experience (OR 0.997, 95% CI 0.982-1.012, p = 0.676) were overall not independently associated with the odds of SSI.","['patients undergoing general, orthopedic trauma and vascular surgery procedures was done between 2012 and 2015\xa0at two tertiary care hospitals in Switzerland/Europe', 'Teaching in the operating room', '4560 patients/surgeries, 1403 (30.8%) were classified as teaching operations']",[],"['surgical experience', 'overall SSI rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C5191358', 'cui_str': '30.8'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",[],"[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]",4560.0,0.036041,"Teaching operations (OR 0.78, 95% CI 0.57-1.07, p = 0.120), junior surgeons (OR 0.80, 95% CI 0.55-1.15, p = 0.229) and surgical experience (OR 0.997, 95% CI 0.982-1.012, p = 0.676) were overall not independently associated with the odds of SSI.","[{'ForeName': 'Edin', 'Initials': 'E', 'LastName': 'Mujagic', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: edin.mujagic@usb.ch.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: hoffmann@zweichirurgen.ch.'}, {'ForeName': 'Savas', 'Initials': 'S', 'LastName': 'Soysal', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: savas.soysal@clarunis.ch.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Delko', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: tarik.delko@clarunis.ch.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mechera', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: robert.mechera@clarunis.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Coslovsky', 'Affiliation': 'Clinical Trial Unit, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: michael.coslovsky@usb.ch.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Zeindler', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: jasmin.zeindler@usb.ch.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Salm', 'Affiliation': 'Department of Surgery, Kantonsspital Aarau, Tellstrasse 15, 5001, Aarau, Switzerland. Electronic address: lilian.salm@insel.ch.'}, {'ForeName': 'Walter R', 'Initials': 'WR', 'LastName': 'Marti', 'Affiliation': 'Department of Surgery, Kantonsspital Aarau, Tellstrasse 15, 5001, Aarau, Switzerland. Electronic address: martiwr@bluewin.ch.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Weber', 'Affiliation': 'Department of Surgery, University of Basel and University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. Electronic address: walter.weber@usb.ch.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.12.029']
2522,32928844,Investigation of predictors of interest in a brief mindfulness-based intervention and its effects in patients with psoriasis at a rehabilitation clinic (SkinMind): an observational study and randomised controlled trial.,"INTRODUCTION


Psoriasis (PS) is a chronic inflammatory skin disease accompanied by reduced quality of life. Mindfulness is the ability to focus on the present moment without evaluation. Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life. However, it remained unclear what distinguishes patients with PS interested in psychological interventions from those without interest and whether also a shorter, namely 2-week mindfulness-based intervention is beneficial in this patient group. This will be investigated with this study.
METHODS AND ANALYSES


Data will be collected at a rehabilitation clinic in Germany. The study is divided into two parts: study 1a is an observational study. Its aim is to investigate whether sociodemographic, skin-related and psychological factors are significant predictors of interest in a brief psychological intervention in 127 patients with PS. Study 1b is a randomised controlled trial, in which 60 patients (retrieved from study 1a) will be randomised to an intervention or control group (treatment as usual). The main outcome variables are mindfulness and self-compassion. In addition, mediation analyses will be used in an explorative manner to test whether there is a relationship between mindfulness/self-compassion and the severity of PS and whether it is mediated by itch catastrophising and fear of negative evaluation (first model) or perceived stress (second model).
ETHICS AND DISSEMINATION


The study protocol has been approved by the University of Giessen. Study results will be disseminated by publication of the results at (inter) national conferences and in scientific journals.
TRIAL REGISTRATION NUMBERS


DRKS00017426 and DRKS00017429.",2020,Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life.,"['60 patients (retrieved from study 1a', 'patients with psoriasis at a rehabilitation clinic (SkinMind', 'patients with PS', 'Data will be collected at a rehabilitation clinic in Germany', '127 patients with PS']",[],"['severity of the disease and quality of life', 'mindfulness and self-compassion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",127.0,0.0474813,Findings on the effects of 8-week mindfulness trainings in patients with PS reveal positive effects on the severity of the disease and quality of life.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Stadtmüller', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eckardt', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zick', 'Affiliation': 'Department of Dermatology, Rehabilitation Clinic Borkum Riff, Borkum, Germany, Borkum, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Kupfer', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schut', 'Affiliation': 'Institute of Medical Psychology, Justus Liebig Universität Giessen, Giessen, Hessen, Germany Christina.Schut@mp.med.uni-giessen.de.'}]",BMJ open,['10.1136/bmjopen-2019-033952']
2523,32929855,Early and maintained application of the secretion of Cryptomphalus aspersa (SCA) 40% improves cutaneous healing after ablative fractional laser in skin aging.,"INTRODUCTION


Ablative fractional laser generates a regulated skin damage which secondary improves skin aging. The main objective of the present study was to figure out if the adverse effects induced by laser and the skin recovery could improve with the application of a cosmetic product based on the secretion of Cryptomphalus aspersa (SCA).
MATERIAL AND METHODS


A prospective double-blind controlled study with vehicle in 10 patients with skin aging. The patients received one session of fractional ablative CO 2  laser and the formulation with SCA 40% was applied immediately and maintained throughout the 21 day duration of the study. The active treatment (SCA) was applied to one hemifacial area and vehicle to the other, the patient acting was her own control. Clinical evaluations, dermoscopy, photography and other parameters like cutaneous hydration, elasticity and wrinkles were evaluated. In addition, the severity of the adverse effects was evaluated.
RESULTS


Significant greater decrease in the density of microcolumns produced by laser were detected on the active-treated side, indicating greater and faster post-procedure recovery compared to the vehicle-treated side. In addition, side effects were reduced and some antiaging effects were more apparent on the side treated with SCA 40%.
CONCLUSIONS


SCA 40% applied immediately after ablative laser and the next days can accelerates laser induced damage regeneration. In addition, SCA improves the cosmetic outcome after laser application.",2020,"RESULTS


Significant greater decrease in the density of microcolumns produced by laser were detected on the active-treated side, indicating greater and faster post-procedure recovery compared to the vehicle-treated side.",['10 patients with skin aging'],"['SCA', 'fractional ablative CO 2  laser and the formulation with SCA']","['cutaneous healing', 'side effects', 'severity of the adverse effects', 'density of microcolumns', 'cosmetic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",10.0,0.0245539,"RESULTS


Significant greater decrease in the density of microcolumns produced by laser were detected on the active-treated side, indicating greater and faster post-procedure recovery compared to the vehicle-treated side.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fernandez-Gonzalez', 'Affiliation': 'Dermatologist in Hospital Central de la Defensa, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Medical Department of Cantabria labs, Madrid, Spain.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Truchuelo', 'Affiliation': 'Dermatologist in Vithas, Nuestra Señora de América Hospital, C/ Bariloche nº 5, 1ºE. 28042, Madrid, Spain.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13720']
2524,32929891,"Azithromycin in high-risk, refractory chronic rhinosinusitus after endoscopic sinus surgery and corticosteroid irrigations: a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Refractory chronic rhinosinusitis (CRS) remains a significant burden for patients, often leaving them with few therapeutic options that provide low-morbidity, long-term, and meaningful symptomatologic and endoscopic disease improvement. Macrolides have long been thought to offer both an immunomodulatory and antimicrobial effect. Our objective was to evaluate the efficacy of low-dose, long-term azithromycin in a carefully selected high-risk population failing appropriate medical therapy of budesonide nasal irrigations (BNIs) and endoscopic sinus surgery (ESS).
METHODS


A double-blind, randomized, placebo-controlled trial was completed in a single tertiary-care center assessing the addition of 250 mg azithromycin, 3 times per week for 16 weeks, in adults failing ESS and high-volume BNIs. Associated comorbidities, as well as symptomatologic, microbiologic, and serologic values, were systematically collected.
RESULTS


A total of 128 patients were enrolled and underwent ESS followed by BNI. At the 4-month post-ESS visit, 48 patients showed disease persistence and were randomized to azithromycin or placebo. Overall, azithromycin, when compared with placebo, did not show a statistically significant difference in disease clearance (54% vs 33%, respectively; p = 0.146), although patients with disease clearance who were on azithromycin showed significantly better 22-item Sino-Nasal Outcome Test score improvements than patients on placebo (18 vs -0.9, respectively; p = 0.046). In a subgroup analysis excluding aspirin-exacerbated respiratory disease (AERD) patients, azithromycin significantly improved disease clearance when compared with placebo (71% vs 35%, respectively; p = 0.031), with a number needed to treat of 3 (2.8).
CONCLUSION


Low-dose azithromycin is a therapeutic option with few side effects. Its use can show favorable clinical outcomes in this difficult-to-treat population, especially if patients are AERD-negative.",2020,"In a subgroup analysis excluding aspirin-exacerbated respiratory disease (AERD) patients, azithromycin significantly improved disease clearance when compared with placebo (71% vs 35%, respectively; p = 0.031), with a number needed to treat of 3 (2.8).
","['adults failing ESS and high-volume BNIs', 'high-risk, refractory chronic rhinosinusitus after endoscopic sinus surgery and corticosteroid irrigations', '48 patients showed disease persistence', '128 patients were enrolled and underwent ESS followed by BNI']","['azithromycin', 'azithromycin or placebo', 'placebo', 'Azithromycin', 'budesonide nasal irrigations (BNIs) and endoscopic sinus surgery (ESS']","['22-item Sino-Nasal Outcome Test score improvements', 'disease clearance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0360546', 'cui_str': 'Budesonide-containing product in nasal dose form'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0969259', 'cui_str': ""bis(O,O'-di-p-tolyldithiophosphato-S,S')(1,10-phenanthroline-N,N')nickel(II)""}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360546', 'cui_str': 'Budesonide-containing product in nasal dose form'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}]","[{'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",128.0,0.7346,"In a subgroup analysis excluding aspirin-exacerbated respiratory disease (AERD) patients, azithromycin significantly improved disease clearance when compared with placebo (71% vs 35%, respectively; p = 0.031), with a number needed to treat of 3 (2.8).
","[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Maniakas', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Marc-Henri', 'Initials': 'MH', 'LastName': 'Asmar', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Axel Eluid', 'Initials': 'AE', 'LastName': 'Renteria', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Smriti', 'Initials': 'S', 'LastName': 'Nayan', 'Affiliation': 'Division of Otolaryngology-Head & Neck Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'Alromaih', 'Affiliation': ""Division of Otolaryngology-Head & Neck Surgery, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Leandra Mfuna', 'Initials': 'LM', 'LastName': 'Endam', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'John Sam', 'Initials': 'JS', 'LastName': 'Sampalis', 'Affiliation': 'Division of Experimental Surgery, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Desrosiers', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}]",International forum of allergy & rhinology,['10.1002/alr.22691']
2525,32929897,[Research and application of artificial intelligence based three-dimensional preoperative planning system for total hip arthroplasty].,"Objective


To develop an artificial intelligence based three-dimensional (3D) preoperative planning system (AIHIP) for total hip arthroplasty (THA) and verify its accuracy by preliminary clinical application.
Methods


The CT image database consisting of manually segmented CT image series was built up to train the independently developed deep learning neural network. The deep learning neural network and preoperative planning module were assembled within a visual interactive interface-AIHIP. After that, 60 patients (60 hips) with unilateral primary THA between March 2017 and May 2020 were enrolled and divided into two groups. The AIHIP system was applied in the trial group (  n =30) and the traditional acetate templating was applied in the control group (  n =30). There was no significant difference in age, gender, operative side, and Association Research Circulation Osseous (ARCO) grading between the two groups (  P >0.05). The coincidence rate, preoperative and postoperative leg length discrepancy, the difference of bilateral femoral offsets, the difference of bilateral combined offsets of two groups were compared to evaluate the accuracy and efficiency of the AIHIP system.
Results


The preoperative plan by the AIHIP system was completely realized in 27 patients (90.0%) of the trial group and the acetate templating was completely realized in 17 patients (56.7%) of the control group for the cup, showing significant difference (  P <0.05). The preoperative plan by the AIHIP system was completely realized in 25 patients (83.3%) of the trial group and the acetate templating was completely realized in 16 patients (53.3%) of the control group for the stem, showing significant difference (  P <0.05). There was no significant difference in the difference of bilateral femoral offsets, the difference of bilateral combined offsets, and the leg length discrepancy between the two groups before operation (  P >0.05). The difference of bilateral combined offsets at immediate after operation was significantly less in the trial group than in the control group (  t =-2.070,  P =0.044); but there was no significant difference in the difference of bilateral femoral offsets and the leg length discrepancy between the two groups (  P >0.05).
Conclusion


Compared with the traditional 2D preoperative plan, the 3D preoperative plan by the AIHIP system is more accurate and detailed, especially in demonstrating the actual anatomical structures. In this study, the working flow of this artificial intelligent preoperative system was illustrated for the first time and preliminarily applied in THA. However, its potential clinical value needs to be discovered by advanced research.",2020,"The preoperative plan by the AIHIP system was completely realized in 25 patients (83.3%) of the trial group and the acetate templating was completely realized in 16 patients (53.3%) of the control group for the stem, showing significant difference (  P <0.05).","['total hip arthroplasty (THA', '60 patients (60 hips) with unilateral primary THA between March 2017 and May 2020 were enrolled and divided into two groups', 'total hip arthroplasty']","['artificial intelligence based three-dimensional preoperative planning system', 'artificial intelligence based three-dimensional (3D) preoperative planning system (AIHIP']","['accuracy and efficiency of the AIHIP system', 'bilateral femoral offsets and the leg length discrepancy', 'bilateral femoral offsets', 'leg length discrepancy', 'age, gender, operative side, and Association Research Circulation Osseous (ARCO) grading', 'coincidence rate, preoperative and postoperative leg length discrepancy']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0191707,"The preoperative plan by the AIHIP system was completely realized in 25 patients (83.3%) of the trial group and the acetate templating was completely realized in 16 patients (53.3%) of the control group for the stem, showing significant difference (  P <0.05).","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, the First Medical Centre, Chinese PLA General Hospital, Beijing, 100853, P.R.China;The Medical District South of Beijing, Chinese PLA General Hospital, Beijing, 100071, P.R.China.'}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Life Sciences, Tsinghua University, Beijing, 100084, P.R.China.'}, {'ForeName': 'Yiling', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Longwood Valley Medical Technology Co. Ltd., Beijing, 100190, P.R.China.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, the First Medical Centre, Chinese PLA General Hospital, Beijing, 100853, P.R.China.'}, {'ForeName': 'Peifu', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedics, the First Medical Centre, Chinese PLA General Hospital, Beijing, 100853, P.R.China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': 'Department of Orthopedics, the First Medical Centre, Chinese PLA General Hospital, Beijing, 100853, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.202005007']
2526,32929901,[Application of lithotomy position in closed reduction and interlocking intramedullary nail fixation for tibial shaft fracture].,"Objective


To explore the application value of lithotomy position in the treatment of tibial shaft fracture with closed reduction and interlocking intramedullary nail fixation.
Methods


The clinical data of 78 patients with tibial shaft fractures treated with closed reduction and interlocking intramedullary nail fixation between January 2015 and May 2018 were retrospectively analyzed. Among them, 33 patients were treated with lithotomy position (trial group) and 45 patients were treated with traditional supine position (control group). There was no significant difference between the two groups in general data such as gender, age, the cause of injury, the interval between injury and admission, the interval between injury and operation, and fracture type and site (  P >0.05). The operation time, intraoperative blood loss, intraoperative fluoroscopy times, the number of patients with open reduction, postoperative incision infection, and fracture healing were recorded. Pain visual analogue scale (VAS) score and Harris score were used to evaluate the effectiveness.
Results


Both groups of operations were successfully completed. The trial group was superior to the control group in terms of operation time, intraoperative blood loss, intraoperative fluoroscopy times, and the number of patients with open reduction (  P <0.05). Incision infection occurred in 1 case (3.03%) of the trial group and 3 cases (6.67%) of the control group after operation. The difference in the incidence of infection was significant (  χ   2 =0.139,  P =0.045). The incisions of other patients healed by first intention. X-ray film reexamination showed that the fractures of the two groups healed. The fracture healing time of the trial group was (5.30±1.33) months, while that of the control group was (5.98±1.80) months, with no significant difference (  t =-1.815,  P =0.073). There was no significant difference in VAS score, Harris scores of knee joint and ankle joint between the two groups before operation and at 3, 6, and 12 months after operation (  P >0.05). At 3 days after operation, the VAS score was lower in the trial group than in the control group, and the Harris scores of knee joint and ankle joint were higher in the trial group than in the control group, and the differences were significant (  P <0.05).
Conclusion


Application of lithotomy position in closed reduction and interlocking intramedullary nail fixation for tibial shaft fracture is favorable for fracture reduction, with less bleeding, shorter operation time, and fewer fluoroscopy.",2020,"The trial group was superior to the control group in terms of operation time, intraoperative blood loss, intraoperative fluoroscopy times, and the number of patients with open reduction (  P <0.05).","['tibial shaft fracture', '78 patients with tibial shaft fractures treated with closed reduction and interlocking intramedullary nail fixation between January 2015 and May 2018 were retrospectively analyzed', '33 patients were treated with']","['interlocking intramedullary nail fixation', 'traditional supine position (control group', 'lithotomy position']","['operation time, intraoperative blood loss, intraoperative fluoroscopy times', 'Incision infection', 'fracture healing time', 'VAS score, Harris scores of knee joint and ankle joint', 'VAS score', 'Harris scores of knee joint and ankle joint', 'Pain visual analogue scale (VAS) score and Harris score', 'incidence of infection', 'operation time, intraoperative blood loss, intraoperative fluoroscopy times, the number of patients with open reduction, postoperative incision infection, and fracture healing']","[{'cui': 'C0588199', 'cui_str': 'Bone structure of shaft of tibia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150665', 'cui_str': 'Lithotomy position'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",78.0,0.0169156,"The trial group was superior to the control group in terms of operation time, intraoperative blood loss, intraoperative fluoroscopy times, and the number of patients with open reduction (  P <0.05).","[{'ForeName': 'Xiande', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Joint Trauma, the First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning Guangxi, 530000, P.R.China.'}, {'ForeName': 'Kuan', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'Department of Joint Trauma, the First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning Guangxi, 530000, P.R.China.'}, {'ForeName': 'Renlei', 'Initials': 'R', 'LastName': 'Qin', 'Affiliation': 'Department of Joint Trauma, the First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning Guangxi, 530000, P.R.China.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Joint Trauma, the First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning Guangxi, 530000, P.R.China.'}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.202002101']
2527,32930057,Predictors of attendance in outpatient group treatment for women with posttraumatic stress disorder and substance use disorder.,"Objective:  The present study investigated predictors of treatment attendance among 226 women with posttraumatic stress disorder (PTSD) and substance use disorder (SUD). Participants received either an integrated intervention for PTSD and SUD (""Seeking Safety"") or a relapse prevention training (RPT) as part of a multicenter randomized controlled trial.  Method:  Beta-binomial regression was conducted to investigate baseline sociodemographic, motivational, mental health and substance use predictors of session attendance. Treatment by predictor interactions were included to identify treatment-specific predictors.  Results:  Session attendance was predicted by employment status, drug use severity and abstinence status. Higher drug use severity and unemployment were associated with less session attendance. The effect of abstinence status was treatment-specific, with abstinent participants in RPT attending most sessions.  Conclusions:  Considering individual characteristics could enhance session attendance in outpatient treatment for women with PTSD and SUD. This might include matching treatment concepts to abstinence status, the identification of attendance barriers in unemployed women and more intensive treatment settings for those with severe drug use.",2020,Higher drug use severity and unemployment were associated with less session attendance.,"['abstinent participants in RPT attending most sessions', '226 women with posttraumatic stress disorder (PTSD) and substance use disorder (SUD', 'women with PTSD and SUD', 'women with posttraumatic stress disorder and substance use disorder']","['integrated intervention for PTSD and SUD (""Seeking Safety"") or a relapse prevention training (RPT']","['employment status, drug use severity and abstinence status']","[{'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",226.0,0.038078,Higher drug use severity and unemployment were associated with less session attendance.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Grundmann', 'Affiliation': 'Center for Interdisciplinary Addiction Research of Hamburg University, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Lotzin', 'Affiliation': 'Center for Interdisciplinary Addiction Research of Hamburg University, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sehner', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Verthein', 'Affiliation': 'Center for Interdisciplinary Addiction Research of Hamburg University, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hiller', 'Affiliation': 'Center for Interdisciplinary Addiction Research of Hamburg University, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Hiersemann', 'Affiliation': 'Center for Interdisciplinary Addiction Research of Hamburg University, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Tania M', 'Initials': 'TM', 'LastName': 'Lincoln', 'Affiliation': 'Clinical Psychology and Psychotherapy, Institute of Psychology, Faculty of Psychology and Movement Sciences, Universität Hamburg, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hillemacher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Paracelsus Medical University, Nuremberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schneider', 'Affiliation': 'Department of Addictive Disorders, Psychiatry and Psychotherapy, LVR-Klinik Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Driessen', 'Affiliation': 'Clinic of Psychiatry and Psychotherapy, Ev. Klinikum Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Scherbaum', 'Affiliation': 'LVR-Hospital Essen, Department of Psychiatry and Psychotherapy, Medical Faculty, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'André C', 'Initials': 'AC', 'LastName': 'Dotten', 'Affiliation': 'Department of Psychiatry, Psychotherapy, Psychosomatic and Addiction Medicine, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schäfer', 'Affiliation': 'Center for Interdisciplinary Addiction Research of Hamburg University, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1817604']
2528,32930088,Treatment of compulsive buying disorder: comparing the effectiveness of cognitive behavioural therapy with person-centred experiential counselling.,"BACKGROUND


Outcome studies of the treatment of compulsive buying disorder (CBD) have rarely compared the effectiveness of differing active treatments.
AIMS


This study sought to compare the effectiveness of cognitive behavioural therapy (CBT) and person-centred experiential therapy (PCE) in a cross-over design.
METHOD


This was an ABC single case experimental design with extended follow-up with a female patient meeting diagnostic criteria for CBD. Ideographic CBD outcomes were intensively measured over a continuous 350-day time series. Following a 1-month baseline assessment phase (A; 28 days; three sessions), CBT was delivered via 13 out-patient sessions (B: 160 days) and then PCE was delivered via six out-patient sessions (C: 63 days). There was a 99-day follow-up period.
RESULTS


Frequency and duration of compulsive buying episodes decreased during active treatment. CBT and PCE were both highly effective compared with baseline for reducing shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem. When the PCE and CBT treatment phases were compared against each other, few differences were apparent in terms of outcome. There was no evidence of any relapse over the follow-up period. A reliable and clinically significant change on the primary nomothetic measure (i.e. Compulsive Buying Scale) was retained over time.
CONCLUSIONS


The study suggests that both CBT and PCE can be effective for CBD. Methodological limitations and suggestions for future CBD outcome research are discussed.",2020,"CBT and PCE were both highly effective compared with baseline for reducing shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem.","['compulsive buying disorder (CBD', 'compulsive buying disorder']","['CBT', 'PCE', 'cognitive behavioural therapy (CBT) and person-centred experiential therapy (PCE', 'CBT and PCE', 'cognitive behavioural therapy with person-centred experiential counselling']","['Frequency and duration of compulsive buying episodes', 'shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem', 'Ideographic CBD outcomes', 'primary nomothetic measure (i.e. Compulsive Buying Scale']","[{'cui': 'C0520949', 'cui_str': 'Compulsive buying'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0520949', 'cui_str': 'Compulsive buying'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0233571', 'cui_str': 'Excitement'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0399357,"CBT and PCE were both highly effective compared with baseline for reducing shopping obsessions, excitement about shopping, compulsion to shop and improving self-esteem.","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kellett', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Pippa', 'Initials': 'P', 'LastName': 'Oxborough', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gaskell', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000521']
2529,32930090,Switching antipsychotic medication to reduce sexual dysfunction in people with psychosis: the REMEDY RCT.,"BACKGROUND


Sexual dysfunction is common among people who are prescribed antipsychotic medication for psychosis. Sexual dysfunction can impair quality of life and reduce treatment adherence. Switching antipsychotic medication may help, but the clinical effectiveness and cost-effectiveness of this approach is unclear.
OBJECTIVE


To examine whether or not switching antipsychotic medication provides a clinically effective and cost-effective method to reduce sexual dysfunction in people with psychosis.
DESIGN


A two-arm, researcher-blind, pilot randomised trial with a parallel qualitative study and an internal pilot phase. Study participants were randomised to enhanced standard care plus a switch of antipsychotic medication or enhanced standard care alone in a 1 : 1 ratio. Randomisation was via an independent and remote web-based service using dynamic adaptive allocation, stratified by age, gender, Trust and relationship status.
SETTING


NHS secondary care mental health services in England.
PARTICIPANTS


Potential participants had to be aged ≥ 18 years, have schizophrenia or related psychoses and experience sexual dysfunction associated with the use of antipsychotic medication. We recruited only people for whom reduction in medication dosage was ineffective or inappropriate. We excluded those who were acutely unwell, had had a change in antipsychotic medication in the last 6 weeks, were currently prescribed clozapine or whose sexual dysfunction was believed to be due to a coexisting physical or mental disorder.
INTERVENTIONS


Switching to an equivalent dose of one of three antipsychotic medications that are considered to have a relatively low propensity for sexual side effects (i.e. quetiapine, aripiprazole or olanzapine). All participants were offered brief psychoeducation and support to discuss their sexual health and functioning.
MAIN OUTCOME MEASURES


The primary outcome was patient-reported sexual dysfunction, measured using the Arizona Sexual Experience Scale. Secondary outcomes were researcher-rated sexual functioning, mental health, side effects of medication, health-related quality of life and service utilisation. Outcomes were assessed 3 and 6 months after randomisation. Qualitative data were collected from a purposive sample of patients and clinicians to explore barriers to recruitment.
SAMPLE SIZE


Allowing for a 20% loss to follow-up, we needed to recruit 216 participants to have 90% power to detect a 3-point difference in total Arizona Sexual Experience Scale score (standard deviation 6.0 points) using a 0.05 significance level.
RESULTS


The internal pilot was discontinued after 12 months because of low recruitment. Ninety-eight patients were referred to the study between 1 July 2018 and 30 June 2019, of whom 10 were randomised. Eight (80%) participants were followed up 3 months later. Barriers to referral and recruitment included staff apprehensions about discussing side effects, reluctance among patients to switch medication and reticence of both staff and patients to talk about sex.
LIMITATIONS


Insufficient numbers of participants were recruited to examine the study hypotheses.
CONCLUSIONS


It may not be possible to conduct a successful randomised trial of switching antipsychotic medication for sexual functioning in people with psychosis in the NHS at this time.
FUTURE WORK


Research examining the acceptability and effectiveness of adjuvant phosphodiesterase inhibitors should be considered.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN12307891.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 44. See the NIHR Journals Library website for further project information.",2020,"To examine whether or not switching antipsychotic medication provides a clinically effective and cost-effective method to reduce sexual dysfunction in people with psychosis.
","['Ninety-eight patients were referred to the study between 1 July 2018 and 30 June 2019, of whom 10 were randomised', 'NHS secondary care mental health services in England', 'people with psychosis', 'Potential participants had to be aged ≥\u200918 years, have schizophrenia or related psychoses and experience sexual dysfunction associated with the use of antipsychotic medication', 'We excluded those who were acutely unwell, had had a change in antipsychotic medication in the last 6 weeks, were currently prescribed clozapine or whose sexual dysfunction was believed to be due to a coexisting physical or mental disorder', 'people who are prescribed antipsychotic medication for psychosis']","['enhanced standard care plus a switch of antipsychotic medication or enhanced standard care alone in a 1\u2009:\u20091 ratio', 'quetiapine, aripiprazole or olanzapine', 'antipsychotic medication']","['patient-reported sexual dysfunction, measured using the Arizona Sexual Experience Scale', 'total Arizona Sexual Experience Scale score', 'researcher-rated sexual functioning, mental health, side effects of medication, health-related quality of life and service utilisation', 'sexual dysfunction']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",98.0,0.137853,"To examine whether or not switching antipsychotic medication provides a clinically effective and cost-effective method to reduce sexual dysfunction in people with psychosis.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Crawford', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Thana', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health and Social Care, University of Bangor, Bangor, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Carne', 'Affiliation': 'Tees, Esk and Wear Valleys NHS Foundation Trust, Darlington, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': ""O'Connell"", 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Claringbold', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Arunan', 'Initials': 'A', 'LastName': 'Saravanamuthu', 'Affiliation': 'Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Case', 'Affiliation': 'Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jasna', 'Initials': 'J', 'LastName': 'Munjiza', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Jayacodi', 'Affiliation': 'Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Reilly', 'Affiliation': 'Tees, Esk and Wear Valleys NHS Foundation Trust, Darlington, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health and Social Care, University of Bangor, Bangor, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Verity C', 'Initials': 'VC', 'LastName': 'Leeson', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Paton', 'Affiliation': 'Oxleas NHS Foundation Trust, Kent, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Keown', 'Affiliation': 'Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Pappa', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Thomas Re', 'Initials': 'TR', 'LastName': 'Barnes', 'Affiliation': 'Division of Psychiatry, Imperial College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24440']
2530,32930131,Neo-adjuvant chemotherapy followed by either continuous hyper-fractionated accelerated radiation therapy week-end less or conventional chemo-radiotherapy in locally advanced NSCLC-A randomised prospective single institute study.,"Context


Better locoregional control and increased overall survival by continuous hyper fractionated accelerated radiotherapy have been shown in unresectable nonsmall cell lung carcinoma (NSCLC). Dose escalation and neoadjuvant chemotherapy (NACT) along with continuous hyperfractionated accelerated radiotherapy week end-less (CHARTWEL) were also tried for improved survival. In this present study, we compared the results of NACT followed by CHARTWEL against NACT followed by conventional concurrent chemo-radiation therapy.
Aims


The aim of this study is to compare the locoregional control and toxicities in NSCLC Stage IIIA and B in both arms.
Settings and Design


Randomized, prospective single-institutional study with a study population comprising all locally advanced unresectable NSCLC patients enrolled in 2014 at our institute.
Subjects and Methods


All enrolled patients were randomized into two arms-CHARTWEL and concomitant chemo-radiotherapy (CCRT), after three weeks of the fourth cycle of NACT. In CHARTWEL arm 30 patients received two-dimensional radiotherapy (RT) 58.5 Gy/39 fr/2.5 weeks while in CCRT arm 30 received 66 Gy/33 fr/6.5 weeks. Disease response was evaluated at 6 months and toxicity assessment during and after treatment completion. Data were analyzed using tools such as percentage, mean, Chi-square test and P value. Chi-square and P value was calculated by statistical online software (http://quantpsy.org).
Results


28% of patients in study arm and 20% in control arm had complete response at 6 months after RT. Locoregional disease control was observed in 44% in study arm and 32% in control arm of patients. There was no statistical difference in grades of toxicities or overall survival (OS)/disease-free survival except persistent esophagitis Grade III seen in two patients of study arm.
Conclusions


Study suggests that CHARTWEL in combination with NACT is an effective strategy to treat patients with locally advanced lung cancer with the advantage of a smaller dose and shorter duration. Although large multivariate studies still needed.",2020,"There was no statistical difference in grades of toxicities or overall survival (OS)/disease-free survival except persistent esophagitis Grade III seen in two patients of study arm.
","['study population comprising all locally advanced unresectable NSCLC patients enrolled in 2014 at our institute', 'patients with locally advanced lung cancer']","['continuous hyper-fractionated accelerated radiation therapy week-end less or conventional chemo-radiotherapy', 'NACT', 'neoadjuvant chemotherapy (NACT', 'concomitant chemo-radiotherapy (CCRT', 'continuous hyper fractionated accelerated radiotherapy', 'dimensional radiotherapy (RT']","['Locoregional disease control', 'locoregional control and toxicities', 'complete response', 'grades of toxicities or overall survival', 'Disease response', 'survival', 'overall survival']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0684249', 'cui_str': 'Lung carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0753125,"There was no statistical difference in grades of toxicities or overall survival (OS)/disease-free survival except persistent esophagitis Grade III seen in two patients of study arm.
","[{'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Kumar', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Paramanandhan', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Purohit', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Jakhar', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Satynarayan', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Maharia', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Rahul Kumar', 'Initials': 'RK', 'LastName': 'Rai', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_377_16']
2531,32930621,"Effects of brief self-exercise education on the management of chronic low back pain: a community-based, randomized, parallel-group pragmatic trial.","Objective:  This study aimed to develop and assess additional effects of brief self-exercise education (brief-See) for individuals with chronic low back pain (CLBP). The brief-See comprised 100-minute consultation, individualized self-exercise program, and direct short teaching. Methods:  We conducted a 6-month, community-based, randomized, parallel-group trial in a community setting, and allocated into a brief-See or material-based education alone. Pain intensity (NRS, numeric rating scale), functional limitation (RDQ, Roland-Morris disability questionnaire), self-efficacy (PSEQ, pain self-efficacy questionnaire), and quality of life (EQ-5D, European quality of life-5 dimensions) were evaluated at 4, 12, and 24 weeks after the initial consultation. Results:  The brief-See did not show additional improvement over material-based education on the NRS, but it did on the RDQ, PSEQ, and EQ-5D; the estimated mean group differences in changes from the baseline were -2.1 (-3.5 to -0.7, P = 0.005) on the RDQ, 6.9 (1.7 to 12.1, P = 0.010) on the PSEQ, and 0.07 (0.02 to 0.12, P = 0.004) on the EQ-5D. Conclusions:  The 100 minutes' education program could be more acceptable, and restores functional limitation, self-efficacy, and quality of life in addition to the effects of material-based education. This has the potential to contribute to the management of CLBP in a community.",2020,"The brief-See did not show additional improvement over material-based education on the NRS, but it did on the RDQ, PSEQ, and EQ-5D; the estimated mean group differences in changes from the baseline were -2.1 (-3.5 to -0.7, P = 0.005) on the RDQ, 6.9 (1.7 to 12.1, P = 0.010) on the PSEQ, and 0.07 (0.02 to 0.12, P = 0.004) on the EQ-5D. Conclusions:  ","['individuals with chronic low back pain (CLBP', 'chronic low back pain']","['brief-See or material-based education alone', 'brief self-exercise education (brief-See', 'brief self-exercise education']","['Pain intensity (NRS, numeric rating scale), functional limitation (RDQ, Roland-Morris disability questionnaire), self-efficacy (PSEQ, pain self-efficacy questionnaire), and quality of life (EQ-5D, European quality of life-5 dimensions', 'functional limitation, self-efficacy, and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0582396', 'cui_str': 'Exercise education'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4075347', 'cui_str': 'Pain Self-efficacy Questionnaire'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0437472,"The brief-See did not show additional improvement over material-based education on the NRS, but it did on the RDQ, PSEQ, and EQ-5D; the estimated mean group differences in changes from the baseline were -2.1 (-3.5 to -0.7, P = 0.005) on the RDQ, 6.9 (1.7 to 12.1, P = 0.010) on the PSEQ, and 0.07 (0.02 to 0.12, P = 0.004) on the EQ-5D. Conclusions:  ","[{'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Department of Hygiene and Public Health, Nippon Medical School, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Matsudaira', 'Affiliation': 'Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical & Research Center, the University of Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Kitamura', 'Affiliation': 'Osaka Center for Cancer and Cardiovascular Disease Prevention, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Kakihana', 'Affiliation': 'Public Health, Department of Social Medicine, Osaka University Graduate School of Medicine, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Oka', 'Affiliation': 'Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical & Research Center, the University of Tokyo, Japan.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Hayama-Terada', 'Affiliation': 'Osaka Center for Cancer and Cardiovascular Disease Prevention, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Yamagishi', 'Affiliation': 'Department of Public Health Medicine, and Health Services Research and Development Center, University of Tsukuba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kiyama', 'Affiliation': 'Osaka Center for Cancer and Cardiovascular Disease Prevention, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iso', 'Affiliation': 'Department of Public Health Medicine, and Health Services Research and Development Center, University of Tsukuba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Modern rheumatology,['10.1080/14397595.2020.1823603']
2532,32930638,Effects of an active intervention based on myofascial release and neurodynamics in patients with chronic neck pain: a randomized controlled trial.,"BACKGROUND


While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness.
OBJECTIVE


The objective of this study was to explore the effects of a 4-week active program based on myofascial release and neurodynamics on trigger point (TrP) examination, pain, and functionality in patients with chronic neck pain.
METHODS


Randomized controlled trial. A total of 40 patients with chronic neck pain were randomly allocated to an experimental or a control group (n = 20). The primary outcome measure was TrP examination. Secondary outcomes were pain, assessed with the Brief Pain Inventory and a visual analogue scale, and functionality, evaluated with the Neck Outcome Score.
RESULTS


A between-group analysis showed significant differences ( p  < .05) in the percentage of active TrPs in the following muscles: suboccipital (50 vs. 92.4% in the right muscle and 37.5 vs. 89.6% in the left muscle), left scalene and levator scapulae. Significant differences ( p  < .05) were also found in pain severity, average pain, and functionality (i.e. symptoms, sleep, and participation).
CONCLUSIONS


A 4-week self-administered program for patients with chronic neck pain was effective in reducing the presence of active TrPs. Pain severity, average pain, and some aspects of functionality also improved significantly after the intervention.",2020,"Significant differences ( p  < .05) were also found in pain severity, average pain, and functionality (i.e. symptoms, sleep, and participation).
","['40 patients with chronic neck pain', 'patients with chronic neck pain']","['4-week active program', 'active intervention']","['Pain severity, average pain', 'myofascial release and neurodynamics on trigger point (TrP) examination, pain, and functionality', 'pain severity, average pain, and functionality (i.e. symptoms, sleep, and participation', 'percentage of active TrPs', 'pain, assessed with the Brief Pain Inventory and a visual analogue scale, and functionality, evaluated with the Neck Outcome Score', 'TrP examination', 'myofascial release and neurodynamics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.290345,"Significant differences ( p  < .05) were also found in pain severity, average pain, and functionality (i.e. symptoms, sleep, and participation).
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Prados-Román', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Granados-Santiago', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Marie Carmen', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada , Granada, Spain.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1821418']
2533,32930640,"Does Social Media Use on Smartphones Influence Endurance, Power, and Swimming Performance in High-Level Swimmers?","Objective : This study aimed to investigate the repeated effect of social media on smartphones immediately before training sessions on inhibitory control (Stroop task), endurance (tethered swimming), countermovement jump (CMJ), and swimming performance (50, 100, and 400-m freestyle) in high-level female swimmers.  Methods : It is a randomized and experimental investigation with parallel groups. Twenty-two participants underwent the eight weeks of the experiment. The swimmers (eight to twelve sessions per week with 15.9 ± 1.6 hours/week, and training experience of ~ 5.6 years) were randomized in two groups: control (CON,  n  = 11) and smartphone (SMA,  n  = 11). Immediately before each training session, the CON group watched videos about Olympic Games for 30-min. The SMA group used social network smartphone apps during 30-min. The inhibitory control, endurance, CMJ, and swimming performance were measured before and after the eight weeks of intervention.  Results : No group x time interaction for 50-m freestyle ( F   (4, 18)  = 1.04;  p  = .33;  η 2  = 0.09 ) and CMJ performance ( F   (4, 18)  = 0.31;  p  = .58;  η 2  = 0.03 ) was found. Both experimental groups improved CMJ ( F   (2, 20)  = 8.71;  p  = .01;  η 2  = 0.46 ). Only the CON group improved the 100-m ( p  = .02), 400-m freestyle ( p  = .01), and endurance performance ( p  = .01). The CON group improved the inhibitory control response ( p  = .01).  Conclusion : It is concluded that the repeated effect of social media on smartphones immediately before swimming training sessions might reduce or nullify training gains on swimming and endurance performance.",2020,"Only the CON group improved the 100-m ( p  = .02), 400-m freestyle ( p  = .01), and endurance performance ( p  = .01).",['high-level female swimmers'],"['CON group watched videos about Olympic Games', 'CON', 'control (CON,  n  =\xa011) and smartphone (SMA,  n  =\xa011', 'SMA']","['endurance performance', 'inhibitory control (Stroop task), endurance (tethered swimming), countermovement jump (CMJ), and swimming performance', 'CMJ performance', 'Smartphones Influence Endurance, Power, and Swimming Performance', 'inhibitory control, endurance, CMJ, and swimming performance', 'inhibitory control response']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0577538', 'cui_str': 'Tethered'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]",22.0,0.0133381,"Only the CON group improved the 100-m ( p  = .02), 400-m freestyle ( p  = .01), and endurance performance ( p  = .01).","[{'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': 'Federal University of Paraíba.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'Federal University of Paraíba.'}, {'ForeName': 'Dalton', 'Initials': 'D', 'LastName': 'Lima-Junior', 'Affiliation': 'Federal University of Paraíba.'}, {'ForeName': 'Maria E C', 'Initials': 'MEC', 'LastName': 'Ferreira', 'Affiliation': 'Federal University of Paraíba.'}, {'ForeName': 'Fabiano S', 'Initials': 'FS', 'LastName': 'Fonseca', 'Affiliation': 'Federal Rural University of Pernambuco.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1810848']
2534,32930649,Comparing Screening Outcomes for Digital Breast Tomosynthesis and Digital Mammography by Automated Breast Density in a Randomized Controlled Trial: Results from the To-Be Trial.,"Background Digital breast tomosynthesis (DBT) is considered superior to digital mammography (DM) for women with dense breasts. Purpose To identify differences in screening outcomes, including rates of recall, false-positive (FP) findings, biopsy, cancer detection rate, positive predictive value of recalls and biopsies, and histopathologic tumor characteristics by density using DBT combined with two-dimensional synthetic mammography (SM) (hereafter, DBT+SM) versus DM. Materials and Methods This randomized controlled trial comparing DBT+SM and DM was performed in Bergen as part of BreastScreen Norway, 2016-2017. Automated software measured density (Volpara Density Grade [VDG], 1-4). The outcomes were compared for DBT+SM versus DM by VDG in descriptive analyses. A stratified log-binomial regression model was used to estimate relative risk of outcomes in subgroups by screening technique. Results Data included 28 749 women, 14 380 of whom were screened with DBT+SM and 14 369 of whom were screened with DM (both groups: median age, 59 years; interquartile range [IQR], 54-64 years). The recall rate was lower for women screened with DBT+SM versus those screened with DM for VDG 1 (2.1% [81 of 3929] vs 3.3% [106 of 3212];  P  = .001) and VDG 2 (3.2% [200 of 6216] vs 4.3% [267 of 6280];  P  = .002). For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8;  P  < .001; VDG 3: 2.4;  P  < .001; VDG 4: 1.8;  P  = .02) and screen-detected breast cancer (VDG 2: 2.4;  P  = .004; VDG 3: 2.8;  P  = .01; VDG 4: 2.8;  P  = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3;  P  = .06; VDG 3: 1.1;  P  = .41; VDG 4: 1.1;  P  = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7;  P  = .13; VDG 3: 2.1;  P  = .06; VDG 4: 2.2;  P  = .15). Conclusion Screening with digital breast tomosynthesis combined with synthetic two-dimensional mammograms (DBT+SM) versus digital mammography (DM) yielded lower recall rates for women with Volpara Density Grade (VDG) 1 and VDG 2. Adjusted relative risk of recall and screen-detected breast cancer increased with denser breasts for DBT+SM but not for DM. © RSNA, 2020  Online supplemental material is available for this article.  See also the editorial by Sechopoulos and Athanasiou in this issue.",2020,"For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8;  P  < .001; VDG 3: 2.4;  P  < .001; VDG 4: 1.8;  P  = .02) and screen-detected breast cancer (VDG 2: 2.4;  P  = .004; VDG 3: 2.8;  P  = .01; VDG 4: 2.8;  P  = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3;  P  = .06; VDG 3: 1.1;  P  = .41; VDG 4: 1.1;  P  = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7;  P  = .13; VDG 3: 2.1;  P  = .06; VDG 4: 2.2;  P  = .15).","['Bergen as part of BreastScreen Norway, 2016-2017', 'women with dense breasts', 'women with Volpara Density Grade (VDG) 1 and VDG 2', '28\u2009749 women, 14\u2009380 of whom were screened with DBT+SM and 14\u2009369 of whom were screened with DM (both groups: median age, 59 years; interquartile range [IQR], 54-64 years']","['DBT+SM and DM', 'Digital Breast Tomosynthesis and Digital Mammography', 'DBT+SM', 'digital breast tomosynthesis combined with synthetic two-dimensional mammograms (DBT+SM) versus digital mammography (DM', ' Digital breast tomosynthesis (DBT', 'digital mammography (DM']","['Adjusted relative risk of recall and screen-detected breast cancer', 'recall rates', 'relative risk of screen-detected breast cancer', 'rates of recall, false-positive (FP) findings, biopsy, cancer detection rate, positive predictive value of recalls and biopsies, and histopathologic tumor characteristics by density using DBT combined with two-dimensional synthetic mammography (SM) (hereafter, DBT+SM) versus DM', 'recall rate']","[{'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}]",28749.0,0.19577,"For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8;  P  < .001; VDG 3: 2.4;  P  < .001; VDG 4: 1.8;  P  = .02) and screen-detected breast cancer (VDG 2: 2.4;  P  = .004; VDG 3: 2.8;  P  = .01; VDG 4: 2.8;  P  = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3;  P  = .06; VDG 3: 1.1;  P  = .41; VDG 4: 1.1;  P  = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7;  P  = .13; VDG 3: 2.1;  P  = .06; VDG 4: 2.2;  P  = .15).","[{'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Moshina', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Hildegunn S', 'Initials': 'HS', 'LastName': 'Aase', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Anders S', 'Initials': 'AS', 'LastName': 'Danielsen', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Ingfrid S', 'Initials': 'IS', 'LastName': 'Haldorsen', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Christoph I', 'Initials': 'CI', 'LastName': 'Lee', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zackrisson', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Hofvind', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}]",Radiology,['10.1148/radiol.2020201150']
2535,32930918,Familial Acculturative Stress and Adolescent Internalizing and Externalizing Behaviors in Latinx Immigrant Families of the Southwest.,"Experiencing acculturative stress burdens Latinx families in a variety of negative and deleterious ways. Using the Family Stress Model, this study aims to explore the patterns and experiences of acculturative stress in Latinx families, and how these experiences related to Latinx adolescent internalizing and externalizing behaviors. Data came from baseline reports of three cohorts of parent-youth dyads (n = 532) participating in a longitudinal randomized control effectiveness trial testing a parenting intervention in southwestern U.S. area. Findings indicate that youth exhibited more depressive symptomology when both parent and child reported higher acculturative stress. While youths' anti-social behaviors were only associated with their own acculturative stress and not their parents' acculturative stress levels. This study advances new knowledge about the relationship between acculturative stress and youth behaviors, and provides recommendations for developing future interventions with Latinx youth to prevent the onset of internalizing and externalizing behaviors.",2020,While youths' anti-social behaviors were only associated with their own acculturative stress and not their parents' acculturative stress levels.,"['in southwestern U.S. area', 'Latinx Immigrant Families of the Southwest']",['parenting intervention'],"['Familial Acculturative Stress and Adolescent Internalizing and Externalizing Behaviors', 'depressive symptomology']","[{'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",532.0,0.0286254,While youths' anti-social behaviors were only associated with their own acculturative stress and not their parents' acculturative stress levels.,"[{'ForeName': 'Shiyou', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'School of Social Work, Southwest Interdisciplinary Research Center, Global Center for Applied Health Research, Arizona State University, 411 N. Central Avenue, Suite 800, Phoenix, AZ, USA. Shiyou.wu@asu.edu.'}, {'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'School of Social Work, Southwest Interdisciplinary Research Center, Global Center for Applied Health Research, Arizona State University, 411 N. Central Avenue, Suite 800, Phoenix, AZ, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ayers', 'Affiliation': 'School of Social Work, Southwest Interdisciplinary Research Center, Global Center for Applied Health Research, Arizona State University, 411 N. Central Avenue, Suite 800, Phoenix, AZ, USA.'}, {'ForeName': 'Olalla', 'Initials': 'O', 'LastName': 'Cutrín', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Southwest Interdisciplinary Research Center, Arizona State University, Phoenix, AZ, USA.'}]",Journal of immigrant and minority health,['10.1007/s10903-020-01084-5']
2536,32930952,Effect of Genetic Polymorphisms on the Pharmacokinetics of Deferasirox in Healthy Chinese Subjects and an Artificial Neural Networks Model for Pharmacokinetic Prediction.,"BACKGROUND AND OBJECTIVE


Deferasirox is an oral iron chelator used to reduce iron levels in iron-overloaded patients with transfusion-dependent anemia or non-transfusion-dependent thalassemia. This study investigated the effects of genetic polymorphisms on the pharmacokinetics of deferasirox in healthy Chinese subjects and constructed a pharmacokinetic prediction model based on physiologic factors and genetic polymorphism data.
METHODS


Twenty-eight subjects were enrolled in a randomized, open-label, two-period crossover study, and they received a single dose of one of two formulations of deferasirox (20 mg/kg) with a 7-day washout interval between the two periods. The plasma defersirox concentration was determined using a validated liquid chromatography-tandem mass spectrometry method, and pharmacokinetic parameters were calculated using the noncompartmental method. The polymorphisms of uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1), UGT1A3, multidrug resistance protein 2 (MRP2), cytochrome P450 1A1 (CYP1A1), and breast cancer resistance protein 1 (BCRP1) were genotyped using Sanger sequencing. A back-propagation artificial neural network (BP-ANN) model was used to predict the pharmacokinetics.
RESULTS


The UGT1A1 rs887829 C > T single-nucleotide polymorphism (SNP) significantly influenced the area under the plasma concentration-time curve and the terminal half-life. Neither the MRP2 rs2273697 G > A SNP nor BCRP1 rs2231142 G > T SNP altered the absorption, disposition, and excretion of the drug. The BP-ANN model had a high goodness-of-fit index and good coherence between the predicted and measured concentrations (R 2  = 0.921).
CONCLUSION


Metabolic enzyme-related genetic polymorphisms were more strongly associated with the pharmacokinetics of deferasirox than membrane transporter-related genetic polymorphisms in the Chinese population.
TRIAL REGISTRATION


www.Chinadrugtrials.org.cn CTR20191164.",2020,"The BP-ANN model had a high goodness-of-fit index and good coherence between the predicted and measured concentrations (R 2  = 0.921).
","['Healthy Chinese Subjects and an Artificial Neural Networks Model for Pharmacokinetic Prediction', 'iron-overloaded patients with transfusion-dependent anemia or non-transfusion-dependent thalassemia', 'Twenty-eight subjects', 'healthy Chinese subjects']",['deferasirox'],"['absorption, disposition, and excretion of the drug', 'uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1), UGT1A3, multidrug resistance protein 2 (MRP2), cytochrome P450 1A1\xa0(CYP1A1), and breast cancer resistance protein 1 (BCRP1', 'plasma defersirox concentration']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3666003', 'cui_str': 'Transfusion dependent anaemia'}, {'cui': 'C3805143', 'cui_str': 'Non-transfusion dependent thalassaemia'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1619629', 'cui_str': 'deferasirox'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0041986', 'cui_str': 'Uridine diphosphate'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0763572', 'cui_str': 'P-glycoprotein 2'}, {'cui': 'C3252639', 'cui_str': 'CYP1A1 protein, human'}, {'cui': 'C0761993', 'cui_str': 'ABCG2 protein, human'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",28.0,0.0262401,"The BP-ANN model had a high goodness-of-fit index and good coherence between the predicted and measured concentrations (R 2  = 0.921).
","[{'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Lou', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Zourong', 'Initials': 'Z', 'LastName': 'Ruan', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China. zrlcyl@zju.edu.cn.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00647-z']
2537,32930958,Apalutamide: A Review in Metastatic Castration-Sensitive Prostate Cancer.,"Apalutamide (Erleada ® ) is an oral selective androgen receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC). In a multinational, phase III study (TITAN) in this patient population, the addition of apalutamide (240 mg once daily) to androgen deprivation therapy (ADT) significantly improved median radiographic progression-free survival (rPFS), median overall survival (OS) and the median time to cytotoxic chemotherapy, while maintaining health-related quality of life (HR-QOL) and not substantially differing from placebo plus ADT in safety. Although mature OS data are awaited with interest, the addition of apalutamide to ADT extends the treatment options available for standard of care in adult men with mCSPC.",2020,It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC).,"['Metastatic Castration-Sensitive Prostate Cancer', 'adult men with metastatic castration-sensitive prostate cancer (mCSPC', 'adult men with mCSPC']","['androgen deprivation therapy (ADT', 'USA', 'Apalutamide (Erleada ® ', 'Apalutamide']","['median radiographic progression-free survival (rPFS), median overall survival (OS) and the median time to cytotoxic chemotherapy, while maintaining health-related quality of life (HR-QOL']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4551002', 'cui_str': 'Erleada'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.11877,It is approved in the EU and the USA for the treatment of adult men with metastatic castration-sensitive prostate cancer (mCSPC).,"[{'ForeName': 'Sheridan M', 'Initials': 'SM', 'LastName': 'Hoy', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-020-01401-0']
2538,32930969,Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data.,"INTRODUCTION


The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study showed that compared with placebo, canagliflozin 100 mg significantly reduced the risk of major cardiovascular events and adverse renal outcomes in patients with diabetic kidney disease (DKD). We developed a simulation model that can be used to estimate the long-term health and economic consequences of DKD treatment interventions for patients matching the CREDENCE study population.
METHODS


The CREDENCE Economic Model of DKD (CREDEM-DKD) was developed using patient-level data from CREDENCE (which recruited patients with estimated glomerular filtration rate 30 to < 90 mL/min/1.73 m 2 , urinary albumin to creatinine ratio > 300-5000 mg/g, and taking the maximum tolerated dose of a renin-angiotensin-aldosterone system inhibitor). Risk prediction equations were fit for start of maintenance dialysis, doubling of serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. A micro-simulation model was constructed using these risk equations combined with user-definable kidney transplant event risks. Internal validation was performed by loading the model to replicate the CREDENCE study and comparing predictions with trial Kaplan-Meier estimate curves. External validation was performed by loading the model to replicate a subgroup of the CANagliflozin cardioVascular Assessment Study (CANVAS) Program with patient characteristics that would have qualified for inclusion in CREDENCE.
RESULTS


Risk prediction equations generally fit well and exhibited good concordance, especially for the placebo arm. In the canagliflozin arm, modest underprediction was observed for myocardial infarction, along with overprediction of dialysis, doubling of serum creatinine, and all-cause mortality. Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68). The model performed well in internal and external validation exercises.
CONCLUSION


CREDEM-DKD is an important new tool in the evaluation of treatment interventions in the DKD population.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02065791.",2020,"Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68).","['recruited patients with estimated glomerular filtration rate 30 to <\u200990\xa0mL', 'patients with diabetic kidney disease (DKD', 'patients matching the CREDENCE study population', 'Diabetic Kidney Disease']","['CREDEM', 'placebo, canagliflozin']","['myocardial infarction', 'macrovascular outcomes and all-cause mortality', 'serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality', 'risk of major cardiovascular events and adverse renal outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",,0.0330236,"Discrimination was strong (0.85) for the renal outcomes, but weaker for the macrovascular outcomes and all-cause mortality (0.60-0.68).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden. mw@ihe.se.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Asseburg', 'Affiliation': 'ESiOR Oy, Kuopio, Finland.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Slee', 'Affiliation': 'Axio Research Inc, Seattle, WA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Neslusan', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00923-w']
2539,32926750,Racial disparities in local therapy for early stage non-small-cell lung cancer.,"OBJECTIVES


This study investigated disparities in the delivery of definitive therapy for early stage non-small-cell lung cancer (ESNSCLC) between Caucasian (CS) and African American (AA) populations.
METHODS


The National Cancer Data Base was queried for AA and CS patients, diagnosed with c stage I Non small cell lung cancer between 2004 and 2015. Trends in surgery, stereotactic ablative radiotherapy (SABR), or external beam radiation therapy (EBRT) were compared. Kaplan-Meier and Cox hazards models were used to compare 5-year overall survival (5YOS).
RESULTS


A total of 174,338 (90.6%) patients were CS and 18,077 (9.4%) patients were AA. AA patients were less likely to receive surgery (60.3% vs. 66.9%; p < .001) and more likely to receive EBRT (12.4% vs. 10.6%; p < .001); however, there was no significant difference in rates of SABR (8.8% vs. 9.2%; p = .066). From 2004 to 2015, the surgery rates increased for AA patients from 44.4% to 61.8% and for CS patients from 57.6% to 65.6%. AA patients had worse 5YOS on an unadjusted analysis (46.7% vs. 47.9%; p = .009). When adjusted for definitive treatment, AA patients had improved survival (hazard ratio = 0.97, 95% confidence interval = 0.94-0.99).
CONCLUSION


Improvements in the delivery of surgery and equal utilization of definitive radiation therapy are at least partially responsible for closing the survival gap between AA and CS patients with ESNSCLC.",2020,"AA patients were less likely to receive surgery (60.3% vs. 66.9%; p < .001) and more likely to receive EBRT (12.4% vs. 10.6%; p < .001); however, there was no significant difference in rates of SABR (8.8% vs. 9.2%; p = .066).","['early stage non-small-cell lung cancer (ESNSCLC) between Caucasian (CS) and African American (AA) populations', 'early stage non-small-cell lung cancer']","['stereotactic ablative radiotherapy (SABR), or external beam radiation therapy (EBRT']","['surgery rates', '5-year overall survival (5YOS', 'rates of SABR', 'survival']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",174338.0,0.355166,"AA patients were less likely to receive surgery (60.3% vs. 66.9%; p < .001) and more likely to receive EBRT (12.4% vs. 10.6%; p < .001); however, there was no significant difference in rates of SABR (8.8% vs. 9.2%; p = .066).","[{'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Lutfi', 'Affiliation': 'Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Martinez-Meehan', 'Affiliation': 'Department of Cardiothoracic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Sultan', 'Affiliation': 'Department of Cardiothoracic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Evans', 'Affiliation': 'Department of Surgery, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Dhupar', 'Affiliation': 'Department of Cardiothoracic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Luketich', 'Affiliation': 'Department of Cardiothoracic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Christie', 'Affiliation': 'Department of Cardiothoracic Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Olugbenga T', 'Initials': 'OT', 'LastName': 'Okusanya', 'Affiliation': 'Department of Surgery, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}]",Journal of surgical oncology,['10.1002/jso.26206']
2540,32926799,Effectiveness of  Curcuma longa  Extract for the Treatment of Symptoms and Effusion-Synovitis of Knee Osteoarthritis : A Randomized Trial.,"BACKGROUND


Current pharmacologic therapies for patients with osteoarthritis are suboptimal.
OBJECTIVE


To determine the efficacy of  Curcuma longa  extract (CL) for reducing knee symptoms and effusion-synovitis in patients with symptomatic knee osteoarthritis and knee effusion-synovitis.
DESIGN


Randomized, double-blind, placebo-controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000080224).
SETTING


Single-center study with patients from southern Tasmania, Australia.
PARTICIPANTS


70 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis.
INTERVENTION


2 capsules of CL ( n  = 36) or matched placebo ( n  = 34) per day for 12 weeks.
MEASUREMENTS


The 2 primary outcomes were changes in knee pain on a visual analogue scale (VAS) and effusion-synovitis volume on magnetic resonance imaging (MRI). The key secondary outcomes were change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and cartilage composition values. Outcomes were assessed over 12 weeks.
RESULTS


CL improved VAS pain compared with placebo by -9.1 mm (95% CI, -17.8 to -0.4 mm [ P  = 0.039]) but did not change effusion-synovitis volume (3.2 mL [CI, -0.3 to 6.8 mL]). CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm];  P  = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]). The incidence of adverse events was similar in the CL ( n  = 14 [39%]) and placebo ( n  = 18 [53%]) groups ( P  = 0.16); 2 events in the CL group and 5 in the placebo group may have been treatment related.
LIMITATION


Modest sample size and short duration.
CONCLUSION


CL was more effective than placebo for knee pain but did not affect knee effusion-synovitis or cartilage composition. Multicenter trials with larger sample sizes are needed to assess the clinical significance of these findings.
PRIMARY FUNDING SOURCE


University of Tasmania and Natural Remedies Private Limited.",2020,"CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm];  P  = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]).","['70 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis', 'Single-center study with patients from southern Tasmania, Australia', 'patients with osteoarthritis are suboptimal', 'Symptoms and Effusion-Synovitis of Knee Osteoarthritis ', 'patients with symptomatic knee osteoarthritis and knee effusion-synovitis']","['2 capsules of CL', 'Curcuma longa  extract (CL', 'placebo', 'Curcuma longa  Extract']","['VAS pain', 'change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and cartilage composition values', 'WOMAC knee pain', 'incidence of adverse events', 'knee pain on a visual analogue scale (VAS) and effusion-synovitis volume on magnetic resonance imaging (MRI', 'lateral femoral cartilage T2 relaxation time']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0409700', 'cui_str': 'Synovitis of knee'}, {'cui': 'C0343166', 'cui_str': 'Knee joint effusion'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",70.0,0.595397,"CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm];  P  = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]).","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Guoqi', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Laslett', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hopper', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia (I.H.).'}, {'ForeName': 'Ambrish', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Royal Hobart Hospital, Hobart, Tasmania, Australia (R.J.).'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Fripp', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia (J.F.).'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia, and Southern Medical University, Guangzhou, China (C.D.).'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}]",Annals of internal medicine,['10.7326/M20-0990']
2541,32926802,Hostility predicts mortality but not recurrent acute coronary syndrome.,"BACKGROUND


Hostility is associated with greater risk for cardiac disease, cardiac events and dysrhythmias. Investigators have reported equivocal findings regarding the association of hostility with acute coronary syndrome (ACS) recurrence and mortality. Given mixed results on the relationship between hostility and cardiovascular outcomes, further research is critical.
AIMS


The aim of our study was to determine whether hostility was a predictor of ACS recurrence and mortality.
METHODS


We performed a secondary analysis of data ( N  = 2321) from a large randomized clinical trial of an intervention designed to reduce pre-hospital delay among patients who were experiencing ACS. Hostility was measured at baseline with the Multiple Adjective Affect Checklist (MAACL) and patients were followed for 24 months for evaluation of ACS recurrence and all-cause mortality. We used Cox proportional hazards modeling to determine whether hostility was predictive of time to ACS recurrence or all-cause mortality.
RESULTS


The majority of patients were married (73%), Caucasian (97%), men (68%), and had a mean age of 67 ± 11 years. Fifty-seven percent of participants scored as hostile based on the established MAACL cut point (mean score = 7.56 ± 3.8). Hostility was an independent predictor of all-cause mortality ( p  = < 0.039), but was not a predictor of ACS recurrence ( p  = 0.792).
CONCLUSION


Hostility is common in patients with ACS and its relationship to clinical outcomes is important to the design of future interventions to improve long-term ACS mortality.",2020,"Hostility was an independent predictor of all-cause mortality ( p  = < 0.039), but was not a predictor of ACS recurrence ( p  = 0.792).
","['patients with ACS', 'patients were married (73%), Caucasian (97%), men (68%), and had a mean age of 67 ± 11 years', 'patients who were experiencing ACS']",[],"['Hostility predicts mortality', 'Hostility', 'ACS recurrence', 'ACS recurrence and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],"[{'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0812095,"Hostility was an independent predictor of all-cause mortality ( p  = < 0.039), but was not a predictor of ACS recurrence ( p  = 0.792).
","[{'ForeName': 'Tracey K', 'Initials': 'TK', 'LastName': 'Vitori', 'Affiliation': 'University of Tennessee College of Nursing, USA.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Frazier', 'Affiliation': 'University of Kentucky College of Nursing, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Biddle', 'Affiliation': 'University of Kentucky College of Nursing, USA.'}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Mudd-Martin', 'Affiliation': 'University of Kentucky College of Nursing, USA.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Pelter', 'Affiliation': 'University of California, San Francisco, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': 'University of California, San Francisco, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'University of Kentucky College of Nursing, USA.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515120950913']
2542,32926803,CPAP Did Not Improve Nonalcoholic Fatty Liver Disease in Patients with Obstructive Sleep Apnea: A Randomized Clinical Trial.,"RATIONALE


Obstructive sleep apnea (OSA) is associated with development of nonalcoholic fatty liver disease (NAFLD). The effects of continuous positive airway pressure (CPAP) on NAFLD in patients with concomitant OSA are unknown.
OBJECTIVES


To investigate the effects of autoCPAP versus subtherapeutic CPAP treatment over 6 months on NAFLD activities.
METHODS


Patients with NAFLD and OSA, as defined by respiratory event index (REI) ≥ 5/hr diagnosed by a validated level 3 Embletta device, were randomized into group A) autoCPAP (4-20cmH2O) or group B) subtherapeutic CPAP (pressure fixed at 4cmH2O). Primary endpoint was the difference in changes in intrahepatic triglyceride (IHTG) as measured by proton-magnetic resonance spectroscopy (MRS) after 6 months of therapy. Key secondary endpoints included changes in controlled attenuation parameter (CAP) and liver stiffness measurement measured with transient elastography, and serum cytokeratin-18 fragment.
MEASUREMENTS AND MAIN RESULTS


A total of 120 patients were randomized equally into two groups. There were significant correlations between CAP and REI(r=0.203, p=0.026), percentage of total recording time with SaO2<90% (r=0.265, p=0.003), and oxygen desaturation index (r=0.214, p=0.019). Following 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the 2 treatment groups. Regression analysis showed that weight change over 6 months correlated with both changes in IHTG and CAP (p<0.001).
CONCLUSION


Despite significant correlations between hepatic steatosis and markers of severity of OSA, CPAP alone did not improve hepatic steatosis and fibrosis. However, additional role of weight reduction through lifestyle modification deserves further investigation. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02728765.",2020,"Following 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the 2 treatment groups.","['Patients with NAFLD and OSA, as defined by respiratory event index (REI) ≥ 5/hr diagnosed by a validated level 3 Embletta device', 'Patients with Obstructive Sleep Apnea', 'Obstructive sleep apnea (OSA', 'A total of 120 patients', 'patients with concomitant OSA are unknown']","['autoCPAP', 'autoCPAP (4-20cmH2O) or group B) subtherapeutic CPAP (pressure fixed at 4cmH2O', 'continuous positive airway pressure (CPAP', 'CPAP', 'subtherapeutic CPAP']","['percentage of total recording time', 'changes in controlled attenuation parameter (CAP) and liver stiffness measurement measured with transient elastography, and serum cytokeratin-18 fragment', 'hepatic steatosis and fibrosis', 'oxygen desaturation index', 'Nonalcoholic Fatty Liver Disease', 'intrahepatic triglyceride (IHTG', 'hepatic steatosis and markers of severity of OSA', 'weight change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",120.0,0.124748,"Following 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the 2 treatment groups.","[{'ForeName': 'Susanna Ss', 'Initials': 'SS', 'LastName': 'Ng', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong.'}, {'ForeName': 'Vincent Ws', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong.'}, {'ForeName': 'Grace Lh', 'Initials': 'GL', 'LastName': 'Wong', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong.'}, {'ForeName': 'Winnie Cw', 'Initials': 'WC', 'LastName': 'Chu', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Imaging & Interventional Radiology, Hong Kong, Hong Kong.'}, {'ForeName': 'Tat-On', 'Initials': 'TO', 'LastName': 'Chan', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong.'}, {'ForeName': 'Kin-Wang', 'Initials': 'KW', 'LastName': 'To', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong.'}, {'ForeName': 'Fanny Ws', 'Initials': 'FW', 'LastName': 'Ko', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong.'}, {'ForeName': 'Ka-Pang', 'Initials': 'KP', 'LastName': 'Chan', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hui', 'Affiliation': 'Chinese University of Hong Kong Faculty of Medicine, 71024, Department of Medicine & Therapeutics, Hong Kong, Hong Kong; dschui@cuhk.edu.hk.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202005-1868OC']
2543,32926814,Rifabutin triple therapy increased  H pylori  eradication vs. amoxicillin + omeprazole in treatment-naive patients.,"SOURCE CITATION


Graham DY, Canaan Y, Maher J, et al.  Rifabutin-based triple therapy (RHB-105) for  Helicobacter pylori  eradication: a double-blind, randomized, controlled trial.  Ann Intern Med. 2020;172:795-802. 32365359.",2020,"Rifabutin-based triple therapy (RHB-105) for  Helicobacter pylori  eradication: a double-blind, randomized, controlled trial.  ",['treatment-naive patients'],"['Rifabutin triple therapy', 'amoxicillin + omeprazole', 'Rifabutin-based triple therapy (RHB-105']",['H pylori  eradication'],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",,0.120731,"Rifabutin-based triple therapy (RHB-105) for  Helicobacter pylori  eradication: a double-blind, randomized, controlled trial.  ","[{'ForeName': 'Jacob Mathew', 'Initials': 'JM', 'LastName': 'Jr', 'Affiliation': 'Parkview Medical Center, Pueblo, Colorado, USA (J.M.J.).'}]",Annals of internal medicine,['10.7326/ACPJ202009150-033']
2544,32926818,Correction: Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study.,,2020,,[],['Metformin or Lifestyle Intervention'],[],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.011246,,[],Annals of internal medicine,['10.7326/L20-0029']
2545,32926823,"In AF with recent ACS or PCI, apixaban improved 30-day outcomes vs. VKAs; aspirin effects varied vs. placebo.","SOURCE CITATION


Alexander JH, Wojdyla D, Vora AN, et al.  Risk/benefit tradeoff of antithrombotic therapy in patients with atrial fibrillation early and late after an acute coronary syndrome or percutaneous coronary intervention: insights from AUGUSTUS.  Circulation. 2020;141:1618-27. 32223444.",2020,"SOURCE CITATION


Alexander JH, Wojdyla D, Vora AN, et al.  ",['patients with atrial fibrillation early and late after an acute coronary syndrome or percutaneous coronary intervention'],"['placebo', 'antithrombotic therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0327559,"SOURCE CITATION


Alexander JH, Wojdyla D, Vora AN, et al.  ","[{'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Hoffer', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA (E.P.H.).'}]",Annals of internal medicine,['10.7326/ACPJ202009150-029']
2546,32926825,"In older patients with NSTE-ACS, clopidogrel safely reduced bleeding compared with ticagrelor at 1 year.","SOURCE CITATION


Gimbel M, Qaderdan K, Willemsen L, et al.  Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial.  Lancet. 2020;395:1374-81. 32334703.",2020,"Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial.  ","['patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE', 'older patients with NSTE-ACS']","['clopidogrel', 'Clopidogrel versus ticagrelor or prasugrel']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]",[],,0.0497171,"Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial.  ","[{'ForeName': 'Michelle D', 'Initials': 'MD', 'LastName': 'Kelsey', 'Affiliation': 'Division of Cardiology, Duke University, Durham, North Carolina, USA (M.K., L.K.N.).'}, {'ForeName': 'L Kristin', 'Initials': 'LK', 'LastName': 'Newby', 'Affiliation': 'Division of Cardiology, Duke University, Durham, North Carolina, USA (M.K., L.K.N.).'}]",Annals of internal medicine,['10.7326/ACPJ202009150-028']
2547,32926834,"Safety and immunogenicity of co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in Gabonese adults: a randomised, controlled, double-blind, phase 1 dose-escalation trial.","BACKGROUND


Hookworms cause substantial morbidity in children and women of reproductive age. The control strategy of mass drug administration is suboptimal, hence the need for a vaccine. Necator americanus aspartic protease-1 (Na-APR-1) and N americanus glutathione S-transferase-1 (Na-GST-1) are involved in the digestion and detoxification of haemoglobin in the hookworm digestive tract. In animal models, vaccination against these antigens resulted in protection from challenge infection. Both vaccine candidates were shown to be safe and well tolerated when administered separately to healthy adults. We assessed the safety and immunogenicity of co-administered Na-GST-1 and Na-APR-1 (M74) vaccines in healthy Gabonese adults.
METHODS


This randomised, controlled, double-blind, phase 1, dose-escalation trial was done at the Centre de Recherches Médicales de Lambaréné, in a region of Gabon where N americanus and other helminths are prevalent. Healthy adults aged 18-50 years and living in Lambaréné or the surrounding areas were recruited to the study. Participants were enrolled consecutively into two dose cohorts (30 μg or 100 μg of the experimental vaccines) and randomly assigned in blocks (block size four) to receive three doses of either co-administered Na-GST-1 plus Na-APR-1 (M74; 30 μg or 100 μg of each), adjuvanted with Alhydrogel (aluminium hydroxide gel suspension) together with an aqueous formulation of glucopyranosyl lipid A, or hepatitis B vaccine plus saline (control group). Vaccines were administered intramuscularly on days 0, 28, and 180. The primary endpoint was safety, with immunogenicity a secondary endpoint. The intention-to-treat population was used for safety analyses, whereas for immunogenicity analyses, the per-protocol population was used (participants who received all scheduled vaccinations). Control vaccine recipients for both dose cohorts were combined for the analyses. The trial is registered with ClinicalTrials.gov, NCT02126462.
FINDINGS


Between Oct 27, 2014, and Jan 31, 2015, 56 individuals were screened for eligibility, of whom 32 were enrolled and randomly assigned to one of the three study groups (12 each in the 30 μg and 100 μg experimental vaccine groups and eight in the control group). Both study vaccines were well tolerated in both dose groups. The most common adverse events were mild-to-moderate injection-site pain, headache, myalgia, and nausea. No severe or serious adverse events related to the vaccines were recorded. 52 unsolicited vaccine-related adverse events occurred during the study, but there was no difference in frequency between vaccine groups. IgG antibodies were induced to each of the vaccine antigens, with mean IgG levels increasing after each vaccination. Vaccination with 100 μg of each vaccine antigen consistently induced IgG seroconversion (IgG levels above the reactivity threshold). Peak IgG responses were observed 2 weeks after the third vaccine dose for both antigens, with all participants who received the 100 μg doses seroconverting at that timepoint. IgG levels steadily declined until the final study visit 6 months after the third vaccination, although they remained significantly higher than baseline in the 100 μg dose group.
INTERPRETATION


Vaccination with recombinant Na-GST-1 and Na-APR-1 (M74) in healthy adults living in N americanus-endemic areas of Gabon was safe and induced IgG to each antigen. To our knowledge, this study is the first to report results of Na-APR-1 (M74) co-administered with Alhydrogel in participants from an N americanus-endemic area. Further clinical development of these vaccines should involve efficacy studies.
FUNDING


European Union Seventh Framework Programme.",2020,"IgG levels steadily declined until the final study visit 6 months after the third vaccination, although they remained significantly higher than baseline in the 100 μg dose group.
","['healthy adults', 'Participants were enrolled consecutively into two dose cohorts (30 μg or 100 μg of the experimental vaccines) and', 'Healthy adults aged 18-50 years and living in Lambaréné or the surrounding areas were recruited to the study', 'Gabonese adults', 'Between Oct 27, 2014, and Jan 31, 2015, 56 individuals were screened for eligibility, of whom 32 were enrolled and randomly assigned to one of the three study groups (12 each in the 30 μg and 100 μg experimental vaccine groups and eight in the control group', 'in participants from an N americanus-endemic area', 'healthy adults living in N americanus-endemic areas of Gabon', 'children and women of reproductive age', 'healthy Gabonese adults']","['Necator americanus aspartic protease-1 (Na-APR-1) and N americanus glutathione S-transferase-1', 'hookworm vaccine candidates', 'randomly assigned in blocks (block size four) to receive three doses of either co-administered Na-GST-1 plus Na-APR-1 (M74; 30 μg or 100 μg of each), adjuvanted with Alhydrogel (aluminium hydroxide gel suspension) together with an aqueous formulation of glucopyranosyl lipid A, or hepatitis B vaccine plus saline (control group', 'Na-APR-1 (M74) co-administered with Alhydrogel', 'recombinant Na-GST-1 and Na-APR-1 (M74', 'co-administered Na-GST-1 and Na-APR-1 (M74) vaccines']","['pain, headache, myalgia, and nausea', 'IgG seroconversion (IgG levels', 'severe or serious adverse events', 'Safety and immunogenicity', 'Peak IgG responses', 'adverse events', 'IgG levels', 'safe and well tolerated', 'tolerated', 'safety and immunogenicity']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0016910', 'cui_str': 'Gabon'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0002826', 'cui_str': 'Necator americanus'}, {'cui': 'C2717969', 'cui_str': 'Aspartic proteinase'}, {'cui': 'C0017837', 'cui_str': 'Glutathione transferase'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0002372', 'cui_str': 'algeldrate'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4276833', 'cui_str': 'glucopyranosyl lipid-A'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",56.0,0.394276,"IgG levels steadily declined until the final study visit 6 months after the third vaccination, although they remained significantly higher than baseline in the 100 μg dose group.
","[{'ForeName': 'Ayola A', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany; Department of Parasitology, Leiden University Medical Center, Leiden, Netherlands; German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Sophia G', 'Initials': 'SG', 'LastName': 'de Vries', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Frejus J', 'Initials': 'FJ', 'LastName': 'Zinsou', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany.'}, {'ForeName': 'Yabo J', 'Initials': 'YJ', 'LastName': 'Honkepehedji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Dejon Agobé', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany; Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Kafui G', 'Initials': 'KG', 'LastName': 'Vodonou', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Rodrigue', 'Initials': 'R', 'LastName': 'Bikangui', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Bouyoukou Hounkpatin', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Bache', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany; Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Massinga Loembe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany.'}, {'ForeName': 'Remko', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Amsterdam Institute for Global Development, Amsterdam, Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Molemans', 'Affiliation': 'Amsterdam Institute for Global Development, Amsterdam, Netherlands.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany; German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Yazdanbakhsh', 'Affiliation': 'Department of Parasitology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hotez', 'Affiliation': ""Texas Children's Hospital Center for Vaccine Development, Departments of Pediatrics and Molecular Virology and Microbiology, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, USA.""}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Bottazzi', 'Affiliation': ""Texas Children's Hospital Center for Vaccine Development, Departments of Pediatrics and Molecular Virology and Microbiology, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, USA.""}, {'ForeName': 'Guangzhao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Bethony', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Diemert', 'Affiliation': 'Department of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington, DC, USA. Electronic address: ddiemert@gwu.edu.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Grobusch', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon; Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany; Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30288-7']
2548,32926841,"Quality of life in patients with metastatic prostate cancer following treatment with cabazitaxel versus abiraterone or enzalutamide (CARD): an analysis of a randomised, multicentre, open-label, phase 4 study.","BACKGROUND


In the CARD study, cabazitaxel significantly improved radiographic progression-free survival and overall survival versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen signalling-targeted inhibitor. Here, we report the quality-of-life outcomes from the CARD study.
METHODS


CARD was a randomised, multicentre, open-label, phase 4 study involving 62 clinical sites across 13 European countries. Patients (aged ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2) with confirmed metastatic castration-resistant prostate cancer were randomly assigned (1:1) by means of an interactive voice-web response system to receive cabazitaxel (25 mg/m 2  intravenously every 3 weeks, 10 mg daily prednisone, and granulocyte colony-stimulating factor) versus abiraterone (1000 mg orally once daily plus 5 mg prednisone twice daily) or enzalutamide (160 mg orally daily). Stratification factors were ECOG performance status, time to disease progression on the previous androgen signalling-targeted inhibitor, and timing of the previous androgen signalling-targeted inhibitor. The primary endpoint was radiographic progression-free survival; here, we present more detailed analyses of pain (assessed using item 3 on the Brief Pain Inventory-Short Form [BPI-SF]) and symptomatic skeletal events, alongside preplanned patient-reported outcomes, assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and the EuroQoL-5 dimensions, 5 level scale (EQ-5D-5L). Efficacy analyses were done in the intention-to-treat population. Pain response was analysed in the intention-to-treat population with baseline and at least one post-baseline assessment of BPI-SF item 3, and patient-reported outcomes (PROs) were analysed in the intention-to-treat population with baseline and at least one post-baseline assessment of either FACT-P or EQ-5D-5L (PRO population). Analyses of skeletal-related events were also done in the intention-to-treat population. The CARD study is registered with ClinicalTrials.gov, NCT02485691, and is no longer enrolling.
FINDINGS


Between Nov 17, 2015, and Nov 28, 2018, of 303 patients screened, 255 were randomly assigned to cabazitaxel (n=129) or abiraterone or enzalutamide (n=126). Median follow-up was 9·2 months (IQR 5·6-13·1). Pain response was observed in 51 (46%) of 111 patients with cabazitaxel and 21 (19%) of 109 patients with abiraterone or enzalutamide (p<0·0001). Median time to pain progression was not estimable (NE; 95% CI NE-NE) with cabazitaxel and 8·5 months (4·9-NE) with abiraterone or enzalutamide (hazard ratio [HR] 0·55, 95% CI 0·32-0·97; log-rank p=0·035). Median time to symptomatic skeletal events was NE (95% CI 20·0-NE) with cabazitaxel and 16·7 months (10·8-NE) with abiraterone or enzalutamide (HR 0·59, 95% CI 0·35-1·01; log-rank p=0·050). Median time to FACT-P total score deterioration was 14·8 months (95% CI 6·3-NE) with cabazitaxel and 8·9 months (6·3-NE) with abiraterone or enzalutamide (HR 0·72, 95% CI 0·44-1·20; log-rank p=0·21). There was a significant treatment effect seen in changes from baseline in EQ-5D-5L utility index score in favour of cabazitaxel over abiraterone or enzalutamide (p=0·030) but no difference between treatment groups for change from baseline in EQ-5D-5L visual analogue scale (p=0·060).
INTERPRETATION


Since cabazitaxel improved pain response, time to pain progression, time to symptomatic skeletal events, and EQ-5D-5L utility index, clinicians and patients with metastatic castration-resistant prostate cancer can be reassured that cabazitaxel will not reduce quality of life when compared with treatment with a second androgen signalling-targeted inhibitor.
FUNDING


Sanofi.",2020,"There was a significant treatment effect seen in changes from baseline in EQ-5D-5L utility index score in favour of cabazitaxel over abiraterone or enzalutamide (p=0·030) but no difference between treatment groups for change from baseline in EQ-5D-5L visual analogue scale (p=0·060).
","['Between Nov 17, 2015, and Nov 28, 2018, of 303 patients screened, 255 were randomly assigned to cabazitaxel (n=129) or', 'patients with metastatic castration-resistant prostate cancer', '62 clinical sites across 13 European countries', 'patients with metastatic prostate cancer', 'Patients (aged ≥18 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2) with confirmed metastatic castration-resistant prostate cancer', '111 patients with cabazitaxel and 21 (19%) of 109 patients with']","['interactive voice-web response system to receive cabazitaxel', 'abiraterone or enzalutamide', 'prednisone, and granulocyte colony-stimulating factor) versus abiraterone (1000 mg orally once daily plus 5 mg prednisone twice daily) or enzalutamide', 'docetaxel', 'cabazitaxel versus abiraterone or enzalutamide (CARD']","['EQ-5D-5L visual analogue scale (p=0·060', 'Median time to symptomatic skeletal events', 'radiographic progression-free survival', 'pain response, time to pain progression, time to symptomatic skeletal events, and EQ-5D-5L utility index', 'Median time to pain progression', 'pain (assessed using item 3 on the Brief Pain Inventory-Short Form [BPI-SF]) and symptomatic skeletal events, alongside preplanned patient-reported outcomes, assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and the EuroQoL-5 dimensions, 5 level scale (EQ-5D-5L', 'quality of life', 'Pain response', 'Quality of life', 'EQ-5D-5L utility index score', 'quality-of-life outcomes', 'radiographic progression-free survival and overall survival', 'Median time to FACT-P total score deterioration']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",255.0,0.285348,"There was a significant treatment effect seen in changes from baseline in EQ-5D-5L utility index score in favour of cabazitaxel over abiraterone or enzalutamide (p=0·030) but no difference between treatment groups for change from baseline in EQ-5D-5L visual analogue scale (p=0·060).
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, Institut Gustave Roussy and University of Paris Saclay, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': 'Gero', 'Initials': 'G', 'LastName': 'Kramer', 'Affiliation': 'Department of Urology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Eymard', 'Affiliation': 'Institut Jean Godinot, Reims, France.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'The Institute of Cancer Research and the Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': '12 de Octubre University Hospital, Madrid, Spain.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wülfing', 'Affiliation': 'Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liontos', 'Affiliation': 'Department of Clinical Therapeutics, Oncology Unit, Alexandra Hospital, Athens, Greece.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Carles', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iacovelli', 'Affiliation': 'Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy; Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'Ásgerður', 'Initials': 'Á', 'LastName': 'Sverrisdóttir', 'Affiliation': 'Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Theodore', 'Affiliation': 'Foch Hospital, Suresnes, France.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Helissey', 'Affiliation': ""Hôpital d'Instruction des Armées BÉGIN, Saint Mandé, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Georges Pompidou European Hospital, Paris Descartes University, Paris, France.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Facchini', 'Affiliation': 'Istituto Nazionale Tumori-IRCCS-Fondazione, Naples, Italy.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Poole', 'Affiliation': 'Sanofi, Global Medical Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ozatilgan', 'Affiliation': 'Sanofi, Global Medical Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Geffriaud-Ricouard', 'Affiliation': 'Sanofi, Europe Medical Oncology, Paris, France.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Bensfia', 'Affiliation': 'Sanofi, Europe Medical Oncology, Paris, France.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30449-6']
2549,32926850,Effects of hyperosmolar dextrose injection in patients with rotator cuff disease and bursitis: a randomized controlled trial.,"OBJECTIVE


To determine whether dextrose prolotherapy offers clinical benefits in patients with shoulder pain and bursitis.
DESIGN


Double-blinded, randomized controlled trial.
SETTING


Outpatient rehabilitation department of a single medical center.
PARTICIPANTS


Fifty patients who had received a diagnosis of shoulder pain and bursitis through clinical tests and ultrasound examination.
INTERVENTIONS


Participants were randomly assigned to the D15W group or the placebo group to receive either 15% dextrose injection or normal saline injection, respectively. All participants received ultrasound-guidance bursal injection every 2 weeks for a total of 3 injections.
OUTCOME MEASURES


The primary outcome was maximal pain level while performing activities. The secondary outcomes included resting pain level, function and disability assessment results, and ultrasonographic parameters. Participants were followed up for 3 months after completion of the injection course.
RESULTS


No significant differences in baseline characteristics were observed between the D15W and placebo groups. Significant time effects were observed for all outcome parameters (all P < .05); however, time × group effects were nonsignificant for all outcomes, except for tissue elasticity (P = .026).
CONCLUSIONS


Supporting evidence is insufficient regarding the clinical benefits of 15% dextrose bursal injection administered through 3 sessions in patients with chronic shoulder pain and bursitis. The findings indicate that these injections may increase the tissue stiffness of the supraspinatus tendon, as indicated by elastography assessment results, but further research is required to determine the nature of such changes in elastography findings.",2020,"Significant time effects were observed for all outcome parameters (all P < .05); however, time × group effects were nonsignificant for all outcomes, except for tissue elasticity (P = .026).
","['patients with shoulder pain and bursitis', 'Fifty patients who had received a diagnosis of shoulder pain and bursitis through clinical tests and ultrasound examination', 'patients with rotator cuff disease and bursitis', 'patients with chronic shoulder pain and bursitis', 'Outpatient rehabilitation department of a single medical center']","['hyperosmolar dextrose injection', 'ultrasound-guidance bursal injection', 'placebo group to receive either 15% dextrose injection or normal saline injection', 'dextrose prolotherapy']","['baseline characteristics', 'tissue stiffness', 'tissue elasticity', 'resting pain level, function and disability assessment results, and ultrasonographic parameters', 'maximal pain level while performing activities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0006444', 'cui_str': 'Bursitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C1562328', 'cui_str': 'Tissue elasticity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",50.0,0.64811,"Significant time effects were observed for all outcome parameters (all P < .05); however, time × group effects were nonsignificant for all outcomes, except for tissue elasticity (P = .026).
","[{'ForeName': 'Yu-Ju', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mackay Memorial Hospital, Mackay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Feng-Hang', 'Initials': 'FH', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, Taipei Medical University, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Peng-Hsuan', 'Initials': 'PH', 'LastName': 'Hou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mackay Memorial Hospital, Mackay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kai-Hsiang', 'Initials': 'KH', 'LastName': 'Tseng', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mackay Memorial Hospital, Mackay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yen-Nung', 'Initials': 'YN', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, Taipei Medical University, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: semitune@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.010']
2550,32926851,Various surfaces benefited functional outcomes and fall incidence in individuals with spinal cord injury: A randomized controlled trial with prospective data follow-up.,"OBJECTIVES


To compare effects of walking training on a walking track with different surfaces (WTDS), including artificial grass, soft, and pebbles, as compared to overground walking training on the functional ability necessary for independence and incidence of falls of ambulatory individuals with spinal cord injury (SCI).
DESIGN


A randomized controlled trial (single-blinded design) with 6-month prospective fall data follow-up.
SETTING


Tertiary rehabilitation centers and several communities.
PARTICIPANTS


Independent ambulatory individuals with SCI who walked with or without a walking device (N = 54).
INTERVENTION


Participants were randomly arranged into a control group (overground walking training, N = 26) or experimental group (walking training over a WTDS, N = 28) for 30 min/day, 5 days/week over 4 weeks.
MAIN OUTCOME MEASURES


The 10-meter walk test, timed up and go test, five times sit-to-stand test, and 6-minute walk test were repeatedly measured 4 times, including before training, and after 2-week and 4-week, and 6 months. In addition, participants were prospectively monitored for the fall data over 6 months.
RESULTS


Participants who walked with an average speed of 0.52 m/s and post-injury time >7 years could safely walk over a WTDS. They demonstrated significant improvement at 2-week and 4-week following experimental training (P<0.001), but not after control training. During 6-month follow-up, participants in the experimental group also had the number of those who fell (n = 5, 18%) fewer than those in the control group (n = 12, 46%).
CONCLUSIONS


Being at a chronic SCI with ability of independent walking, participants needed a challenging task to promote their functional outcomes and minimize fall risk. The findings suggest the use of various surfaces as an alternative rehabilitation strategy for these individuals.",2020,"They demonstrated significant improvement at 2-week and 4-week following experimental training (P<0.001), but not after control training.","['Tertiary rehabilitation centers and several communities', 'Independent ambulatory individuals with SCI who walked with or without a walking device (N = 54', 'ambulatory individuals with spinal cord injury (SCI', 'Participants who walked with an average speed of 0.52 m/s and post-injury time >7 years could safely walk over a WTDS', 'individuals with spinal cord injury']","['control group (overground walking training, N = 26) or experimental group (walking training over a WTDS', 'walking training', 'overground walking training']","['10-meter walk test, timed up and go test, five times sit-to-stand test, and 6-minute walk test']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]",54.0,0.0231193,"They demonstrated significant improvement at 2-week and 4-week following experimental training (P<0.001), but not after control training.","[{'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand; Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand. Electronic address: samata@kku.ac.th.'}, {'ForeName': 'Donlaya', 'Initials': 'D', 'LastName': 'Promkeaw', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand; Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Preeda', 'Initials': 'P', 'LastName': 'Arrayawichanon', 'Affiliation': 'Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand; Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thiwabhorn', 'Initials': 'T', 'LastName': 'Thaweewannakij', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand; Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Pipatana', 'Initials': 'P', 'LastName': 'Amatachaya', 'Affiliation': 'Improvement of Physical Performanceo and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand; Department of Mechanical Engineering, Faculty of Engineering and Architecture, Rajamangala University of Technology Isan, Nakhon Ratchasima, Thailand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.009']
2551,32927075,Preventive Effect of High-Dose Digestive Enzyme Management on Development of Nonalcoholic Fatty Liver Disease after Pancreaticoduodenectomy: A Randomized Controlled Clinical Trial.,"BACKGROUND


Nonalcoholic fatty liver disease (NAFLD) is a complication of pancreaticoduodenectomy (PD). We conducted a randomized clinical trial to determine if high-dose digestive enzymes prevented the development of NAFLD after PD.
STUDY DESIGN


This parallel-group, non-blinded and multicenter study enrolled patients undergoing elective PD at Shinshu University School of Medicine from June 2011 to April 2017. Patients were randomly assigned to receive normal-dose (Excelase: 3.0 g/day) or high-dose digestive enzyme treatment (Excelase: 3.0 g/day, Pancreatin: 3.0 g/day, Berizym: 3.0 g/day, Toughmac-E: 3.0 g/day) within 1 week after surgery. Because patients in the control group switched interventions upon receiving a diagnosis of NAFLD, intention-to-treat analysis was used. The primary endpoint was incidence of NAFLD within 1 year and the secondary were the incidence of NAFLD at 1, 3, 6, and 12 months and the rate of improvement in NAFLD with high-dose transfer in the control group. The secondary analysis comprised assessment of risk factors for the development of NAFLD.
RESULTS


84 patients were randomly assigned (42 per group), of whom 80 were finally analyzed (39 normal-dose, 41 high-dose). The incidence of NAFLD was significantly lower in the high-dose (8/41) compared with the normal-dose (25/39) (P<0.001). Multivariate analysis identified normal-dose (odds ratio (OR) 14.65, P<0.001), total protein ≤ 6.5g/dl (OR 9.01, P=0.018), pre-albumin ≤ 22.0 mg/dl (OR 7.71, P=0.018), and pancreatic function diagnostic test ≤ 70% (OR 6.66, P=0.009) as independent risk factors. There were no adverse effects. The model was accurate (c-index=0.92) and reliable (Hosmer-Lemeshow test P=0.32).
CONCLUSIONS


High-dose administration of digestive enzymes significantly reduced the onset of NAFLD after PD compared with normal-dose administration. Registration number: UMIN000005595 (http://www.umin.ac.jp/ctr/).",2020,The incidence of NAFLD was significantly lower in the high-dose (8/41) compared with the normal-dose (25/39) (P<0.001).,"['84 patients', 'Nonalcoholic Fatty Liver Disease after Pancreaticoduodenectomy', 'enrolled patients undergoing elective PD at Shinshu University School of Medicine from June 2011 to April 2017']","['normal-dose (Excelase: 3.0 g/day) or high-dose digestive enzyme treatment (Excelase', 'High-Dose Digestive Enzyme Management', 'Pancreatin']","['incidence of NAFLD within 1 year and the secondary were the incidence of NAFLD', 'incidence of NAFLD', 'adverse effects', 'onset of NAFLD', 'pancreatic function diagnostic test', 'rate of improvement in NAFLD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0544420', 'cui_str': 'Digestive enzyme'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030304', 'cui_str': 'Pancreatin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0232786', 'cui_str': 'Pancreatic function'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}]",84.0,0.359798,The incidence of NAFLD was significantly lower in the high-dose (8/41) compared with the normal-dose (25/39) (P<0.001).,"[{'ForeName': 'Koya', 'Initials': 'K', 'LastName': 'Yasukawa', 'Affiliation': 'Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery, Department of Surgery, Shinshu University School of Medicine, Matsumoto, Japan. Electronic address: kouyayasu@shinshu-u.ac.jp.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimizu', 'Affiliation': 'Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery, Department of Surgery, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Takahide', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Gastroenterological Surgery, National Hospital Organization Shinshu Ueda Medical Center, Ueda, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery, Department of Surgery, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Notake', 'Affiliation': 'Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery, Department of Surgery, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Seki', 'Affiliation': 'Gastroenterological Surgery, Nagano Municipal Hospital, Nagano, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery, Department of Surgery, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Soejima', 'Affiliation': 'Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery, Department of Surgery, Shinshu University School of Medicine, Matsumoto, Japan.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.08.761']
2552,32927091,Transcranial direct current stimulation accelerates the onset of exercise-induced hypoalgesia: a randomised controlled study.,"Exercise-induced hypoalgesia (EIH) describes acute reductions in pain that occur following exercise. Current evidence suggests that the magnitude of EIH is small-to-moderate at best, warranting exploration of novel avenues to bolster these effects. Transcranial direct current stimulation (tDCS) has been shown to relieve pain and represents a promising intervention that may enhance EIH. This study aimed to determine whether anodal tDCS of the primary motor cortex (M1) can augment EIH in healthy individuals experiencing experimentally-induced musculoskeletal pain. Twenty-four healthy subjects attended two experimental sessions ('Day 0' and 'Day 2'). On Day 0, subjects were injected with nerve growth factor (NGF) into their right extensor carpi radialis brevis to induce persistent elbow pain. On Day 2, each subject received active or sham tDCS over M1 followed by an isometric grip exercise. Pain intensity, muscle soreness, sensitivity (pressure pain thresholds) and conditioned pain modulation were assessed prior to the NGF injection, on Day 2 before tDCS, immediately post-exercise, and 15 minutes post-exercise. Active tDCS expedited the onset of EIH, inducing immediate reductions in pain intensity that were not present until 15 minutes post-exercise in the sham group. However, active tDCS did not reduce muscle soreness or sensitivity when compared to sham tDCS. Perspective: These findings suggest that active tDCS accelerates the onset of EIH in healthy individuals experiencing experimentally-induced pain. This may represent a promising means of enhancing adherence to exercise protocols. However, larger randomised controlled trials in persistent pain populations are required to confirm the clinical impact of these findings.",2020,"Pain intensity, muscle soreness, sensitivity (pressure pain thresholds) and conditioned pain modulation were assessed prior to the NGF injection, on Day 2 before tDCS, immediately post-exercise, and 15 minutes post-exercise.","['healthy individuals experiencing experimentally-induced musculoskeletal pain', 'Twenty-four healthy subjects', 'healthy individuals experiencing experimentally-induced pain']","['Transcranial direct current stimulation (tDCS', 'anodal tDCS of the primary motor cortex (M1', 'Exercise-induced hypoalgesia (EIH', 'nerve growth factor (NGF) into their right extensor carpi radialis brevis', 'active tDCS', 'Transcranial direct current stimulation', 'active or sham tDCS over M1 followed by an isometric grip exercise']","['Pain intensity, muscle soreness, sensitivity (pressure pain thresholds) and conditioned pain modulation', 'muscle soreness or sensitivity', 'pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0454331', 'cui_str': 'Gripping exercises'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",24.0,0.244874,"Pain intensity, muscle soreness, sensitivity (pressure pain thresholds) and conditioned pain modulation were assessed prior to the NGF injection, on Day 2 before tDCS, immediately post-exercise, and 15 minutes post-exercise.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Borovskis', 'Affiliation': 'School of Health Sciences, Western Sydney University, NSW 2560, Australia; Brain Stimulation and Rehabilitation Lab, Western Sydney University, NSW 2560, Australia.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Cavaleri', 'Affiliation': 'School of Health Sciences, Western Sydney University, NSW 2560, Australia; Brain Stimulation and Rehabilitation Lab, Western Sydney University, NSW 2560, Australia.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Blackstock', 'Affiliation': 'School of Health Sciences, Western Sydney University, NSW 2560, Australia.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Summers', 'Affiliation': 'School of Health Sciences, Western Sydney University, NSW 2560, Australia; Brain Stimulation and Rehabilitation Lab, Western Sydney University, NSW 2560, Australia; Discipline of Sport and Exercise Science, Faculty of Health, University of Canberra, ACT 2617, Australia; Research School of Biology, Australian National University, ACT 2600, Australia. Electronic address: summers.simonj@gmail.com.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.08.004']
2553,32927099,"A prospective, international, randomized, non-inferiority study comparing an titanium implantable vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study).",,2020,,[],['titanium implantable vertebral augmentation device versus balloon kyphoplasty'],[],[],"[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]",[],,0.014045,,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Noriega', 'Affiliation': 'Hospital Clinico-Universitario de Valladolid, Calle Ramon y Cajal S/n, 47008 Valladolid, Spain. Electronic address: noriega1970@icloud.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Marcia', 'Affiliation': 'Direttore U.O.C. Radiologia, Ospedale SS. Trinità ASL8, via Is Mirrionis 92, 09121 Cagliari, Sardinia, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Theumann', 'Affiliation': ""Department of Radiology, Bois-Cerf Clinic, Avenue d'Ouchy 31, 1006 Lausanne, Switzerland.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Blondel', 'Affiliation': 'Department of Orthopaedic, Trauma and Spine surgery, CHU de La Timone, 264 rue Saint Pierre, 13385 Marseille, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'Department of Neurosurgery, Locomotor Centre, CHU Brest Cavale Blanche, Bd Tanguy Prigent, 29609 Brest, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hassel', 'Affiliation': 'Chefarzt Wirbelsäulenchirurgie, Loretto-Krankenhaus Freiburg, Mercystr. 6-14, 79100 Freiburg, Germany.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Maestretti', 'Affiliation': 'Department of Orthopaedic Surgery, HFR Fribourg, Cantonal Hospital, 1er étage, Case postale 1708, Fribourg, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Petit', 'Affiliation': 'Neurosurgery Unit, Hôpital Jean Minjoz, 3 Boulevard Alexandre Fleming, 25030 Besançon, France.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Weidle', 'Affiliation': 'Krankenhaus NEUWERK, Sankt Augustinus Kliniken, Dünner Strasse 214-216, 41066 Mönchengladbach, Germany.'}, {'ForeName': 'Andres Mandly', 'Initials': 'AM', 'LastName': 'Gonzalez', 'Affiliation': 'Interventional Neuroradiology, Hospital Universitario Marqués de Valdecilla, Av. Valdecilla, s/n, 39008 Santander, Spain.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Kaya', 'Affiliation': 'APHM, Hopital Nord, Pavillon Mistral, 1er étage, Chemin des Bourrely, 13915 Marseille, France.'}, {'ForeName': 'Adamou', 'Initials': 'A', 'LastName': 'Touta', 'Affiliation': 'APHM, Hopital Nord, Pavillon Mistral, 1er étage, Chemin des Bourrely, 13915 Marseille, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Fuentes', 'Affiliation': 'Neurosurgery Unit, CHU La Timone-Hôpital Adultes-5eme étage, 264 rue Saint Pierre, 13385 Marseille, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pflugmacher', 'Affiliation': 'Klinik und Poliklinik für Orthopädie und Unfallchirurgie, UniversitätsklinikumBonn, Sigmund-Freud-Str. 25, 53127 Bonn, Germany.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.08.021']
2554,32927145,"A Commentary on ""The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial"" (International Journal of Surgery 2020; 77:183-6).",,2020,,['conscious patients'],['internal jugular vein catheterization under ultrasound-guidance'],[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]",[],,0.0942218,,"[{'ForeName': 'Baoji', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesia, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Rd. Pudong New District, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesia, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Rd. Pudong New District, Shanghai, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesia, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Rd. Pudong New District, Shanghai, China. Electronic address: duanhongwei120@126.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.047']
2555,32927476,A human randomized controlled trial comparing metabolic responses to single and repeated hypoglycemia in type 1 diabetes.,"AIMS


Hypoglycemia hinders optimal glycemic management in type 1 diabetes (T1D). Long diabetes duration and hypoglycemia impair hormonal counterregulatory responses to hypoglycemia. Our study was designed to test whether i) the metabolic responses and insulin sensitivity are impaired, and ii) affected by short-lived antecedent hypoglycemia in participants with T1D.
MATERIALS AND METHODS


In a randomized, crossover, 2x2-factorial design, nine male participants with T1D and nine comparable control participants underwent 30 min hypoglycemia (p-glucose<2.9mmol/L) followed by a euglycemic clamp on two separate interventions: with and without 30 min hypoglycemia the day before the study day.
RESULTS


During both interventions: insulin sensitivity was consistently lower, while counterregulatory hormones were reduced with 75% lower glucagon and 50% lower epinephrine during hypoglycemia in participants with T1D, who also displayed 40% lower lactate and 5-10-fold increased ketone bodies concentrations following hypoglycemia, whereas palmitate and glucose turnover, forearm glucose uptake and substrate oxidation did not differ between the groups. In participants with T1D, adipose tissue PTEN content, HSL phosphorylation and muscle GLUT4 content were decreased compared with controls. An antecedent hypoglycemic episodes lasting 30 minutes did not affect counter-regulation or insulin sensitivity.
CONCLUSIONS


Participants with T1D displayed insulin resistance, and impaired hormonal counter-regulation during hypoglycemia, whereas glucose and fatty acid fluxes were intact, and ketogenic responses amplified. We observed subtle alterations of intracellular signaling, and no effect of short-lived antecedent hypoglycemia on subsequent counter-regulation. This plausibly reflects the presence of insulin resistance, and implies that T1D is a condition with defective hormonal but preserved metabolic responsiveness to short-lived hypoglycemia.",2020,GLUT4 content were decreased compared with controls.,"['type 1 diabetes (T1D', 'nine male participants with T1D and nine comparable control participants underwent 30\xa0min hypoglycemia (p-glucose<2.9mmol/L) followed by a', 'type 1 diabetes']","['epinephrine', 'euglycemic clamp']","['ketone bodies concentrations', 'adipose tissue PTEN content, HSL phosphorylation and muscle', 'GLUT4 content', 'palmitate and glucose turnover, forearm glucose uptake and substrate oxidation', 'counterregulatory hormones', 'insulin sensitivity']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}]","[{'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1430988', 'cui_str': 'PTEN protein, human'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",9.0,0.0812553,GLUT4 content were decreased compared with controls.,"[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bisgaard Bengtsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Støy', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Nikolaj Fibiger', 'Initials': 'NF', 'LastName': 'Rittig', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Thomas Schmidt', 'Initials': 'TS', 'LastName': 'Voss', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Nils Erik', 'Initials': 'NE', 'LastName': 'Magnusson', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Mads Vadsted', 'Initials': 'MV', 'LastName': 'Svart', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa645']
2556,32927487,Calcitriol Effect on Outcomes of in Vitro Fertilization in Infertile Women with Vitamin D Deficiency: A Double-Blind Randomized Clinical Trial.,"INTRODUCTION


Recent studies have addressed the role of micronutrients in fertilization, such as vitamin D. The present study aims to explore the effects of using calcitriol, an active form of vitamin D, on IVF results in women with vitamin D deficiency.
METHOD


This double-blinded randomized clinical trial was done on 180 infertile women, undergone IVF treatment. Out of them, 95 were found to have vitamin D deficiency (blood serum 25-dihydroxy vitamin D <30 ng/ml). Fifty one women in experimental group were treated with two 0.25 µg calcitriol pills daily during 4 weeks (discontinued 8 hours prior to the embryo transfer) and 44 subjects to the placebo group (mean vitamin D deficiency 27.5 ±1.8 in case group vs. 27.6±1.8 in control group, P>0.05). Final analysis includes outcomes of chemical and clinical pregnancy was done on 74 women (including 36 in case and 38 in control group).
RESULTS


Our study showed that in the experimental group, chemical pregnancy success was significantly higher than that in the control group, 31.4 vs. 18.2% (P<0.05). However, there were no significant differences between the 2 groups in reaching the clinical pregnancy stage (25.5% in case group vs. 13.6% in control group) and continuation of pregnancy into week 20 (9.8% in case group vs. 11.6% in control group) (P>0.05).
CONCLUSION


Calcitriol administration by improving the implantation process can significantly increase the chances of successful IVF cycle results in infertile women with vitamin D deficiency.",2020,"However, there were no significant differences between the 2 groups in reaching the clinical pregnancy stage (25.5% in case group vs. 13.6% in control group) and continuation of pregnancy into week 20 (9.8% in case group vs. 11.6% in control group) (P>0.05).
","['women with vitamin D deficiency', '74 women (including 36 in case and 38 in control group', 'Infertile Women with Vitamin D Deficiency', '180 infertile women, undergone IVF treatment', 'infertile women with vitamin D deficiency']","['calcitriol pills', 'calcitriol', 'placebo', 'Calcitriol']","['clinical pregnancy stage', 'chemical pregnancy success', 'chemical and clinical pregnancy', 'vitamin D deficiency', 'Vitro Fertilization', 'continuation of pregnancy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3207493', 'cui_str': 'Calcitriol Pill'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2919902', 'cui_str': 'Chemical pregnancy'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}]",180.0,0.433962,"However, there were no significant differences between the 2 groups in reaching the clinical pregnancy stage (25.5% in case group vs. 13.6% in control group) and continuation of pregnancy into week 20 (9.8% in case group vs. 11.6% in control group) (P>0.05).
","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Doryanizadeh', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran (the Islamic Republic of).'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Morshed-Behbahani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran (the Islamic Republic of).'}, {'ForeName': 'Mohammad Ebrahim', 'Initials': 'ME', 'LastName': 'Parsanezhad', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School, Shiraz University of Medical Sciences, Shiraz, Iran (the Islamic Republic of).'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Dabbaghmanesh', 'Affiliation': 'Shiraz endocrine research center, Shiraz University of Medical Sciences, Shiraz, Iran (the Islamic Republic of).'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Jokar', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran (the Islamic Republic of).'}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-1206-1064']
2557,32927668,Cocoa-Rich Chocolate and Quality of Life in Postmenopausal Women: A Randomized Clinical Trial.,"Menopause has a negative impact on quality of life (QoL). The aim of the present study was to analyse the effect on QoL of adding 10 g per day of chocolate with a high concentration of cocoa (99%) to the habitual diet, for 6 months, in a sample of postmenopausal women. Postmenopausal women ( n  = 140) aged 50-64 years were randomised to either an addition of 10 g per day of cocoa-rich chocolate to their usual diet or no supplement addition. All variables were measured at baseline and after six months of intervention. QoL was evaluated using the 3-level version of EuroQol-5D (EuroQoL-5D-3L), the EuroQol Visual Analogue Scale (EQ-VAS) and the Cervantes scale. Analysis of covariance (ANCOVA) analyses adjusted for the main determinants of QoL considered in this study showed no changes in the global score of QoL evaluated with the EuroQoL-5D-3L. The intervention group showed an increase of 6.0 points (95% confidence interval (CI): 0.4, 11.7) in the EQ-VAS compared to the control group ( p  = 0.036). No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale. The additional daily contribution of 10 g of cocoa-rich chocolate in postmenopausal women could have a slight impact on their perception toward their health state, although without modifying the health-related QoL or the dimensions that compose it.",2020,No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale.,"['Postmenopausal Women', 'Postmenopausal women ( n  = 140) aged 50-64 years', 'postmenopausal women']","['cocoa-rich chocolate', 'Cocoa-Rich Chocolate', 'chocolate with a high concentration of cocoa (99%) to the habitual diet', 'cocoa-rich chocolate to their usual diet or no supplement addition']","['3-level version of EuroQol-5D (EuroQoL-5D-3L), the EuroQol Visual Analogue Scale (EQ-VAS) and the Cervantes scale', 'global score of QoL', 'quality of life (QoL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",140.0,0.0901054,No significant changes were observed between groups in the global score of QoL nor in the dimensions and subdimensions measured with the Cervantes scale.,"[{'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Garcia-Yu', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Olaya', 'Initials': 'O', 'LastName': 'Tamayo-Morales', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernandez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), 37005 Salamanca, Spain.'}]",Nutrients,['10.3390/nu12092754']
2558,32927674,"Use of End-of-Class Quizzes to Promote Pharmacy Student Self-Reflection, Motivate Students to Improve Study Habits, and to Improve Performance on Summative Examinations.","Underperforming students are often unaware of deficiencies requiring improvement until after poor performance on summative exams. The goal of the current study was to determine whether inclusion of individual end-of-class formative quizzes, which comprise of higher level Bloom's questions, could encourage students to reflect on and address deficiencies and improve academic performance. Ninety-seven out of 123 first-year pharmacy students (79%) enrolled in a Biochemistry and Cell & Molecular Biology course participated in a single-blinded, randomized, controlled, crossover study. Paired  t -test analyses demonstrated that that implementation of individual end-of-class formative quizzes resulted in significantly higher summative exam scores for below average students ( p  = 0.029). Notably, inclusion of quizzes significantly improved performance on higher Bloom's questions for these students ( p  = 0.006). Analysis of surveys completed by students prior to summative exam indicate that the formative end-of-class quizzes helped students identify deficiencies (89%) and making them feel compelled to study more (83%) and attend review sessions (61%). Many students indicated that quizzes increased stress levels (45%). Our collective data indicate that quizzes can improve summative exam performance for below average first year pharmacy students, and improve self-reflection and student motivation to study. However, the impact on student stress levels should be considered.",2020,"Notably, inclusion of quizzes significantly improved performance on higher Bloom's questions for these students ( p  = 0.006).","['Ninety-seven out of 123 first-year pharmacy students (79%) enrolled in a Biochemistry and Cell & Molecular Biology course participated', 'Underperforming students']",[],"['summative exam performance', 'summative exam scores', 'stress levels']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026376', 'cui_str': 'Biology, Molecular'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",123.0,0.0147359,"Notably, inclusion of quizzes significantly improved performance on higher Bloom's questions for these students ( p  = 0.006).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Vinall', 'Affiliation': 'Department of Pharmaceutical & Biomedical Sciences, College of Pharmacy, California Northstate University, Elk Grove, CA 95826, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kreys', 'Affiliation': 'Department of Clinical & Administrative Sciences, College of Pharmacy, California Northstate University, Elk Grove, CA 95826, USA.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8030167']
2559,32927677,"Black Soybean Improves Vascular Function and Blood Pressure: A Randomized, Placebo Controlled, Crossover Trial in Humans.","Vascular dysfunction and injurious stimuli such as oxidative stress are closely related to the risk of cardiovascular diseases (CVD). Dietary polyphenols are reported to exert beneficial effects in reducing the risk of CVD. Black soybean has been used as a nutritionally rich food and contains abundant polyphenols in its seed coat and grain. Black soybean has many beneficial physiological activities, and its prevention effects on CVD risk were reported mainly in animal experiments. In this study, we performed a randomized, single blind, placebo controlled, crossover trial to investigate the effect of black soybean consumption on the vascular function in healthy humans. Twenty-two healthy adults aged from 30 to 60 completed the four week trial with daily consumption of about a 40 g test material cookie containing 20 g roasted black soybean powder. Body composition, vascular function, biomarkers for oxidative stress, and polyphenol contents in the urine and the plasma were measured. After ingestion of the black soybean cookie, vascular function, which was evaluated by plethysmogram using a Pulse Analyzer ® , was improved and systolic blood pressure was decreased. Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine. These results suggest that the antioxidant activity of black soybean polyphenols and an increase in the nitric oxide level may contribute to the improvement of vascular function. Thus, black soybean is an attractive food material for improvement of vascular function through decreasing oxidative stress by its potent antioxidant activity and increasing the nitric oxide level in healthy humans.",2020,"Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine.","['healthy humans', 'Humans', 'Twenty-two healthy adults aged from 30 to 60 completed the four week trial with']","['daily consumption of about a 40 g test material cookie containing 20 g roasted black soybean powder', 'black soybean consumption', 'placebo', 'Black Soybean', 'Placebo']","['nitric oxide level', 'Vascular Function and Blood Pressure', 'vascular function', 'nitric oxide levels in plasma and urine', 'systolic blood pressure', 'Body composition, vascular function, biomarkers for oxidative stress, and polyphenol contents', ""oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level""]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}]",22.0,0.139485,"Moreover, nitric oxide levels in plasma and urine were increased, while an oxidative stress biomarker, 8-hydroxy-2'-deoxyguanosine level, in the plasma was decreased accompanied by an increase in the concentration of polyphenols derived from black soybean in plasma and urine.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Nanba', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Toda', 'Affiliation': 'Fujicco Co. Ltd., Research Development, 6-13-4, Minatojima-Nakamachi, Chuo-Ku, Kobe 650-8558, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nakagawa', 'Affiliation': 'Nakagawa Clinic, 3-15-4, Higashisonoda-cho, Amagasaki 661-0953, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ashida', 'Affiliation': 'Department of Agrobioscience, Graduate School of Agricultural Science, Kobe University, 1-1, Rokkodai-cho, Nada-ku, Kobe 657-8501, Japan.'}]",Nutrients,['10.3390/nu12092755']
2560,32927741,Frailty Intervention through Nutrition Education and Exercise (FINE). A Health Promotion Intervention to Prevent Frailty and Improve Frailty Status among Pre-Frail Elderly-A Study Protocol of a Cluster Randomized Controlled Trial.,"The ageing process has been associated with various geriatric issues including frailty. Without early prevention, frailty may cause multiple adverse outcomes. However, it potentially may be reversed with appropriate interventions. The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly. A 3-month, single-blind, two-armed, cluster randomized controlled trial of the frailty intervention program among Malaysian pre-frail elderly will be conducted. A minimum of total 60 eligible respondents from 8 clusters (flats) of Program Perumahan Rakyat (PPR) flats will be recruited and randomized to the intervention and control arm. The intervention group will receive a nutritional education and a low to moderate multi-component exercise program. To date, this is the first intervention study that specifically targets both the degree of frailty and an improvement in the outcomes of frailty using both nutritional education and exercise interventions among Malaysian pre-frail elderly. If the study is shown to be effective, there are major potential benefits to older population in terms of preventing transition to frailty. The findings from this trial will potentially provide valuable evidence and serve as a model for similar future interventions designed for elderly Malaysians in the community.",2020,The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly.,"['total 60 eligible respondents from 8 clusters (flats) of Program Perumahan Rakyat (PPR) flats', 'Malaysian pre-frail elderly']","['nutritional education and a low to moderate multi-component exercise program', 'frailty intervention program', 'Health Promotion Intervention', 'nutritional education and exercise interventions', 'nutritional education and exercise intervention', 'Frailty Intervention through Nutrition Education and Exercise (FINE']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205232', 'cui_str': 'Fine'}]",[],60.0,0.045271,The aim of the study is to assess the effectiveness of nutritional education and exercise intervention to prevent frailty among the elderly.,"[{'ForeName': 'Nurul Izzati', 'Initials': 'NI', 'LastName': 'Mohd Suffian', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': ""Siti Nur 'Asyura"", 'Initials': ""SN'"", 'LastName': 'Adznam', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Hazizi', 'Initials': 'H', 'LastName': 'Abu Saad', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Yoke Mun', 'Initials': 'YM', 'LastName': 'Chan', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Zuriati', 'Initials': 'Z', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Omar', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}, {'ForeName': 'Muhammad Faizal', 'Initials': 'MF', 'LastName': 'Murat', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor 43400, Malaysia.'}]",Nutrients,['10.3390/nu12092758']
2561,32927752,Cooking for Vitality: Pilot Study of an Innovative Culinary Nutrition Intervention for Cancer-Related Fatigue in Cancer Survivors.,"(1) Background: Cancer-related fatigue (CRF) is one of the most prevalent and distressing side effects experienced by patients with cancer during and after treatment, and this negatively impacts all aspects of quality of life. An increasing body of evidence supports the role of poor nutritional status in the etiology of CRF and of specific diets in mitigating CRF. We designed a group-based two session culinary nutrition intervention for CRF, Cooking for Vitality (C4V), aimed at increasing understanding of how food choices can impact energy levels and establishing basic food preparation and cooking skills as well as the application of culinary techniques that minimize the effort/energy required to prepare meals. The purpose of this pilot mixed-method study was to evaluate: Feasibility of the experimental methods and intervention; acceptability and perceived helpfulness of intervention; and to obtain a preliminary estimate of the effectiveness of the intervention on fatigue (primary outcome), energy, overall disability, and confidence to manage fatigue (secondary outcomes). (2) Methods: Prospective, single arm, embedded mixed-methods feasibility study of cancer survivors with cancer-related fatigue was conducted. Participants completed measures at baseline (T0), immediately following the intervention (T1), and three months after the last session (T2). Qualitative interviews were conducted at T2. (3) Results: Recruitment (70%) and retention (72%) rates along with qualitative findings support the feasibility of the C4V intervention for cancer survivors living with CRF (program length and frequency, ease of implementation, and program flexibility). Acceptability was also high and participants provided useful feedback for program improvements. Fatigue (FACT-F) scores significantly improved from T0-T1 and T0-T2 ( p  < 0.001). There was also a significant decrease in disability scores (WHO-DAS 2.0) from T0-T2 ( p  = 0.006) and an increase in POMS-Vigor (Profile of Mood States) from T0-T1 ( p  = 0.018) and T0-T2 ( p  = 0.013). Confidence in managing fatigue improved significantly from T0-T1 and T0-T2 ( p  < 0.001). (4) Conclusions: The results suggest that the C4V program was acceptable and helpful to patients and may be effective in improving fatigue levels and self-management skills. A randomized controlled trial is required to confirm these findings.",2020,Fatigue (FACT-F) scores significantly improved from T0-T1,"['cancer survivors living with CRF (program length', 'cancer survivors with cancer-related fatigue was conducted', 'Cancer-Related Fatigue in Cancer Survivors']","['T0-T1', 'Innovative Culinary Nutrition Intervention', 'C4V intervention']","['POMS-Vigor (Profile of Mood States', 'Fatigue (FACT-F) scores', 'disability scores', 'fatigue levels and self-management skills', 'fatigue (primary outcome), energy, overall disability, and confidence to manage fatigue (secondary outcomes', 'Acceptability', 'Confidence in managing fatigue']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0591028,Fatigue (FACT-F) scores significantly improved from T0-T1,"[{'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Pritlove', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON M5G 1B1, Canada.""}, {'ForeName': 'Geremy', 'Initials': 'G', 'LastName': 'Capone', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Kita', 'Affiliation': 'MD Program, Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gladman', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Manjula', 'Initials': 'M', 'LastName': 'Maganti', 'Affiliation': 'Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Jones', 'Affiliation': 'Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada.'}]",Nutrients,['10.3390/nu12092760']
2562,32927753,Potato Preload Mitigated Postprandial Glycemic Excursion in Healthy Subjects: An Acute Randomized Trial.,"This study investigated the preload effect of the medium and high glycemic index (GI) potato, as well as the combination of partially hydrolyzed guar gum (HG) and potato, when ingested prior to a rice meal, on the iso-carbohydrate basis. In a randomized crossover trial, 17 healthy female subjects consumed (1) rice; (2) co-ingestion of highly cooked potato (HP), and rice (HP + R); (3) co-ingestion of minimally cooked potato (MP) and rice (MP + R); (4) preload HP prior to rice meal (PHP + R); (5) preload MP prior to rice meal (PMP + R); (6) co-ingestion of partially hydrolyzed guar gum (HG), HP and rice (HG + HP + R); (7) preload HG prior to co-ingestion of HP and rice (PHG + HP + R); (8) co-preload of HG and HP prior to rice (PHG + PHP + R); and (9) preload of HP prior to co-ingestion of HG and rice (PHP + HG + R). Postprandial glycemic response (GR) tests and subjective satiety tests were conducted for each test food. Cooked potato as a preload to a rice meal could significantly cut the acute postprandial glycemic excursion by around 1.0 mmol/L, irrespective of the GI of the preload. Co-preload of partial hydrolyzed guar gum and highly cooked potato (PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload. All the meals with preload showed comparable or improved self-reported satiety. Within an equicarbohydrate exchange framework, both high-GI and medium-GI potato preload decreased the postprandial glycemic excursion in young healthy female subjects. The combination of HG and HP as double preload resulted in better GR than both single HG or HP preload did.",2020,(PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload.,"['young healthy female subjects', '17 healthy female subjects consumed (1) rice; (2', 'Healthy Subjects']","['co-ingestion of highly cooked potato (HP), and rice (HP + R); (3) co-ingestion of minimally cooked potato (MP) and rice (MP + R); (4) preload HP prior to rice meal (PHP + R); (5) preload MP prior to rice meal (PMP + R); (6) co-ingestion of partially hydrolyzed guar gum (HG), HP and rice (HG + HP + R', 'high-GI and medium-GI potato preload', 'Co-preload of partial hydrolyzed guar gum and highly cooked potato', 'preload HG prior to co-ingestion of HP and rice (PHG + HP + R); (8) co-preload of HG and HP prior to rice (PHG + PHP + R); and (9) preload of HP prior to co-ingestion of HG and rice (PHP + HG + R', 'PHG + PHP + R']","['Postprandial glycemic response (GR) tests and subjective satiety tests', 'self-reported satiety', 'Postprandial Glycemic Excursion', 'peak glucose value and glycemic excursion', 'postprandial glycemic excursion', 'acute postprandial glycemic excursion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0061996', 'cui_str': 'guar gum'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0728938', 'cui_str': 'Partial'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",17.0,0.012354,(PHG + PHP + R) resulted in improved acute GR in terms of peak glucose value and glycemic excursion compared with either HG preload or HP preload.,"[{'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.'}]",Nutrients,['10.3390/nu12092759']
2563,32928024,Blunted opioid regulation of the HPA stress response during nicotine withdrawal: Therapeutic implications.,"Background . Endogenous opioids regulate pain, drug reward, and stress responses. We have previously shown reduced hypothalamic-pituitary-adrenal (HPA) responses to psychological stress and to opioid blockade among dependent smokers. In this study, we examined the extent to which biologically confirmed nicotine withdrawal alters endogenous opioid regulation of HPA axis functioning during rest and in response to acute stress. Design and Methods . Smokers were randomly assigned to one of two conditions; 24 hr withdrawal from all nicotine-containing products (n = 62) or smoking ad libitum (n = 44). A non-smoking comparison group (n = 43) was also included. Participants (85 males and 64 females) completed two acute stress sessions during which a placebo or 50 mg of naltrexone (opioid antagonist) were administered using a double-blind design. Blood and saliva samples (assayed for cortisol and adrenocorticotropic hormone, i.e., ACTH) and mood measures were obtained during a resting absorption period, after acute stress (public speaking, mental arithmetic, and cold pressor tasks), and during an extended recovery period. Results . Opioid blockade (naltrexone) was associated with increased ACTH and cortisol responses to stress, and tobacco withdrawal was associated with blunted hormonal responses. A pattern of sex differences also emerged, with women exhibiting reduced ACTH responses to stress and higher ACTH and plasma cortisol response to opioid blockade. Conclusions . Compared to ad libitum smoking, nicotine withdrawal is associated with blunted opioid modulation of the HPA axis. Sex may modulate these effects. Blunted endogenous opioid regulation may underlie an incentive process that reinforces smoking behavior and may warrant therapeutic attention.",2020,"A pattern of sex differences also emerged, with women exhibiting reduced ACTH responses to stress and higher ACTH and plasma cortisol response to opioid blockade.",['Participants (85 males and 64 females) completed two acute stress sessions during which a'],"['24\u2009hr withdrawal from all nicotine-containing products (n\u2009=\u200962) or smoking ad libitum', 'placebo or 50\u2009mg of naltrexone (opioid antagonist', 'Opioid blockade (naltrexone']","['Endogenous opioids regulate pain, drug reward, and stress responses', 'ACTH responses to stress and higher ACTH and plasma cortisol response', 'hypothalamic-pituitary-adrenal (HPA) responses', 'acute stress (public speaking, mental arithmetic, and cold pressor tasks', 'ACTH and cortisol responses to stress, and tobacco withdrawal', 'Blood and saliva samples (assayed for cortisol and adrenocorticotropic hormone, i.e., ACTH) and mood measures', 'HPA stress response']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",85.0,0.0887215,"A pattern of sex differences also emerged, with women exhibiting reduced ACTH responses to stress and higher ACTH and plasma cortisol response to opioid blockade.","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'University of Minnesota Medical School, Duluth, MN 55812.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Nakajima', 'Affiliation': 'University of Minnesota Medical School, Duluth, MN 55812.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'DeAngelis', 'Affiliation': 'University of Minnesota Medical School, Duluth, MN 55812.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Grant', 'Affiliation': 'University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'University of Chicago, Chicago, IL 60637.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grabowski', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN 55455.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN 55455.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN 55455.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2020.1823367']
2564,32928030,The application of intracavitary electrocardiogram for tip location of femoral vein catheters in chemotherapy patients with superior vena cava obstruction.,"BACKGROUND


Most studies focused on the application of intracavitary electrocardiogram (IC-ECG) location in superior vena cava access catheterization, this study aimed to explore the effect of IC-ECG for tip location of femoral vein catheters in chemotherapy patients with superior vena cava obstruction (SVCO).
METHODS


A total of 158 patients placed catheters through superficial femoral vein from July 2016 to May 2019 were enrolled in the randomized controlled study. The patients were divided into two groups by envelope lottery method: X-ray location was used in the control group ( n  = 79); IC-ECG location was used in the observation group ( n  = 79). The catheters should be located at or near the inferior vena cava (IVC)-right atrium (RA) junction (above the level of diaphragm within the IVC). The general information of patients, clinical catheterization effects and catheter-related complications were compared between the groups.
RESULTS


No significant differences in general information, catheter obstruction, catheter-related thrombosis, catheter exit-site bleeding and infection were found between the groups. The rate of successful insertion at the first attempt and patient satisfaction in the observation group were significantly higher than that in the control group ( p  < 0.05). The time and cost of location and the incidence of catheter-related complications in the control group were 32.57 min and 140.51 Yuan and 21.5%, which were significantly higher than 6.94 min and 13.59 Yuan and 7.6% in the observation group ( p  < 0.05).
CONCLUSION


IC-ECG accurately located the tip of femoral vein catheters, reduced the incidence of catheter-related complications and the time and cost of location, improved patient satisfaction.",2020,"No significant differences in general information, catheter obstruction, catheter-related thrombosis, catheter exit-site bleeding and infection were found between the groups.","['158 patients placed catheters through superficial femoral vein from July 2016 to May 2019 were enrolled', 'chemotherapy patients with superior vena cava obstruction (SVCO', 'chemotherapy patients with superior vena cava obstruction']","['IC-ECG', 'intracavitary electrocardiogram', 'intracavitary electrocardiogram (IC-ECG) location']","['general information, catheter obstruction, catheter-related thrombosis, catheter exit-site bleeding and infection', 'clinical catheterization effects and catheter-related complications', 'rate of successful insertion at the first attempt and patient satisfaction', 'incidence of catheter-related complications and the time and cost of location, improved patient satisfaction', 'time and cost of location and the incidence of catheter-related complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038833', 'cui_str': 'Superior vena cava syndrome'}]","[{'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3494210', 'cui_str': 'Catheter Obstruction'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C4303069', 'cui_str': 'Catheter exit site'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948806', 'cui_str': 'Catheter related complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",158.0,0.0239836,"No significant differences in general information, catheter obstruction, catheter-related thrombosis, catheter exit-site bleeding and infection were found between the groups.","[{'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Teaching and Research Section of Clinical Nursing, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jinghui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Teaching and Research Section of Clinical Nursing, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Jianmei', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'National Clinical Research Center for Geriatric Disorders, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'National Clinical Research Center for Geriatric Disorders, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zixin', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Teaching and Research Section of Clinical Nursing, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shujie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Teaching and Research Section of Clinical Nursing, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoya', 'Initials': 'X', 'LastName': 'Kong', 'Affiliation': 'Teaching and Research Section of Clinical Nursing, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhengkun', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Respiratory Medicine, Xiangya Hospital of Central South University, Changsha, Hunan, China.'}]",The journal of vascular access,['10.1177/1129729820958334']
2565,32928045,"No need to use both Disabilities of the Arm, Shoulder and Hand and Constant-Murley score in studies of midshaft clavicular fractures.","Background and purpose - Most newer randomized studies examining plate fixation and nonoperative treatment of midshaft clavicular fractures utilize both Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley score (CS) in the evaluation of patient outcomes. Compared with DASH, the use of CS requires on-site trained personnel and patient visits to obtain the score. The use of both DASH and CS should provide extra value compared with the use of a single functional outcome score; if this value is not provided, the combined use is not necessary. We evaluated the agreement between DASH and CS in patients with displaced midshaft clavicular fractures. Patients and methods - We used prospectively collected data from 146 patients enrolled in a randomized study comparing operative and nonoperative treatment of midshaft clavicular fractures. We determined correlation between DASH and CS at all follow-up points and calculated mean bias in the Bland-Altman plot. Results - We found moderate to high correlation (from 0.82 at 6 weeks' follow-up to 0.58 at 1-year follow-up) between DASH and CS score, and a small bias (2.21 [95% CI 0.22-4.20]) in the Bland-Altman plot. Interpretation - In patients with displaced midshaft clavicular fractures DASH and CS measures the same degree of disability. Unless specifically studying strength and range of motion, we recommend the sole use of DASH as it would eliminate potential observer-induced bias along with removing the economic and logistic burden of obtaining CS without compromising the value of the collected data.",2020,"We found moderate to high correlation (from 0.82 at 6 weeks' follow-up to 0.58 at 1-year follow-up) between DASH and CS score, and a small bias (2.21 [95% CI 0.22-4.20]) in the Bland-Altman plot.","['146 patients enrolled in a randomized study comparing operative and nonoperative treatment of midshaft clavicular fractures', 'patients with displaced midshaft clavicular fractures']","['plate fixation and nonoperative treatment', 'DASH and CS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],146.0,0.0325674,"We found moderate to high correlation (from 0.82 at 6 weeks' follow-up to 0.58 at 1-year follow-up) between DASH and CS score, and a small bias (2.21 [95% CI 0.22-4.20]) in the Bland-Altman plot.","[{'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Qvist', 'Affiliation': 'Department of Orthopedics, Aarhus University Hospital;'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Vaesel', 'Affiliation': 'Department of Orthopedics, Viborg Regional Hospital;'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Moss', 'Affiliation': 'Department of Orthopedics, Randers Regional Hospital;'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Orthopedics, Alborg University Hospital, Denmark.'}, {'ForeName': 'Steen L', 'Initials': 'SL', 'LastName': 'Jensen', 'Affiliation': 'Department of Orthopedics, Alborg University Hospital, Denmark.'}]",Acta orthopaedica,['10.1080/17453674.2020.1820274']
2566,32928049,Timing the First Pediatric Tracheostomy Tube Change: A Randomized Controlled Trial.,"OBJECTIVE


The first pediatric tracheostomy tube change often occurs within 7 days after placement; however, the optimal timing is not known. The primary objective was to determine the rate of adverse events of an early tube change. Secondary objectives compared rates of significant peristomal wounds, sedation requirements, and expedited intensive care discharges.
STUDY DESIGN


Prospective randomized controlled trial.
SETTING


Tertiary children's hospital between October 2018 and April 2020.
METHODS


A randomized controlled trial enrolled children under 24 months to early (day 4) or late (day 7) first tracheostomy tube changes.
RESULTS


Sixteen children were enrolled with 10 randomized to an early change. Median age was 5.9 months (interquartile range, 5.4-8.3), and 86.7% required tracheostomy for respiratory failure. All tracheostomy tube changes were performed without adverse events. There were no accidental decannulations. Significant wounds developed in 10% of children with early tracheostomy tube changes and 83.3% of children with late tracheostomy tube changes (odds ratio [OR], 45.0; 95% CI, 2.3-885.6;  P  = .01). This significant reduction in wound complications justified concluding trial enrollment. Hours of dexmedetomidine sedation ( P  = .11) and boluses of midazolam during the first 7 days ( P  = .08) were no different between groups. After the first change, 90% of the early group were discharged from intensive care within 5 weeks compared to 33.3% of patients in the late group (OR, 18.0; 95% CI, 1.2-260.9;  P  = .03).
CONCLUSION


The first tracheostomy tube change in children can occur without adverse events on day 4, resulting in fewer significant peristomal wounds and earlier intensive care discharge.",2020,Hours of dexmedetomidine sedation ( P  = .11) and boluses of midazolam during the first 7 days ( P  = .08) were no different between groups.,"['enrolled children under 24 months to early (day 4) or late (day 7) first tracheostomy tube changes', ""Tertiary children's hospital between October 2018 and April 2020"", 'Sixteen children were enrolled with 10 randomized to an early change']","['midazolam', 'dexmedetomidine']","['rate of adverse events of an early tube change', 'discharged from intensive care', 'rates of significant peristomal wounds, sedation requirements, and expedited intensive care discharges']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0184159', 'cui_str': 'Tracheostomy tube'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]",16.0,0.199616,Hours of dexmedetomidine sedation ( P  = .11) and boluses of midazolam during the first 7 days ( P  = .08) were no different between groups.,"[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Chorney', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Rosemary C', 'Initials': 'RC', 'LastName': 'Patel', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Boyd', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stow', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Schmitt', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lipman', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Dailey', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Nhan', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Giordano', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Sobol', 'Affiliation': ""Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820954137']
2567,32928070,A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).,"OBJECTIVES


To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence.
METHOD


This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS).
RESULTS


Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT).
CONCLUSIONS


RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome. Registration:  Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.",2020,"RESULTS


Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001).",['56 patients with VLU divided into'],"['compression alone (CR, N\u2009=\u200929) and RFA plus compression', 'saphenous and perforating veins radiofrequency ablation', 'radiofrequency endovenous ablation (RFA) of saphenous and perforating veins']","['venous leg ulcer (VLU) healing rates', 'ulcer recurrence rate', 'ulcer healing rates', 'healing rates', 'Healing velocity', 'ulcer healing velocity; and Venous Clinical Severity Score (VCSS', 'Recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",56.0,0.0632548,"RESULTS


Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001).","[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Puggina', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Igor Rafael', 'Initials': 'IR', 'LastName': 'Sincos', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Campos', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Rina Maria P', 'Initials': 'RMP', 'LastName': 'Porta', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Jorgete Barreto', 'Initials': 'JB', 'LastName': 'Dos Santos', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'De Luccia', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Puech-Leão', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Felipe Birchal', 'Initials': 'FB', 'LastName': 'Collares', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Erasmo Simão', 'Initials': 'ES', 'LastName': 'da Silva', 'Affiliation': 'Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.'}]",Phlebology,['10.1177/0268355520951697']
2568,32928119,Dynamic needle tip positioning versus the angle-distance technique for ultrasound-guided radial artery cannulation in adults: a randomized controlled trial.,"BACKGROUND


Ultrasound guidance can increase the success rate and reduce the incidence of complications of arterial cannulation. There are few studies on the utility of the dynamic needle tip positioning (DNTP) technique versus the angle-distance (AD) technique for ultrasound-guided radial arterial cannulation in adult surgical patients. We assessed and compared the success rates and incidences of complications of these two short-axis out-of-plane techniques.
METHODS


A total of 131 adult surgical patients were randomized into DNTP and AD groups to undergo ultrasound-guided radial artery cannulation. The primary outcome was first-pass success without posterior wall puncture. The secondary outcomes included the first-pass success rate, 10-min overall success rate, cannulation time, posterior wall puncture, and the number of skin punctures.
RESULTS


The first-pass success rates without posterior wall puncture were 53.8% in the DNTP group and 44.6% in the AD group (RR = 1.22, 95% CI: 0.86-1.72; P = 0.26). The cannulation time was significantly longer (P = 0.01) in the DNTP group [79.65 (54.3-109.4) seconds] than in the AD group [47.6 (24.9-103.8) seconds]. The posterior wall puncture rate was significantly lower (P = 0.002) in the DNTP group (29.2%) than in the AD group (56.1%; RR = 0.56, 95% CI: 0.42-0.82).
CONCLUSIONS


There were no significant differences in the first-pass success rate, with or without arterial posterior wall puncture, or in the 10-min overall success rate between the DNTP and AD groups. However, the cannulation time was longer and the posterior wall puncture rate was lower in the DNTP group.
TRIAL REGISTRATION


The trial was registered at www.clinicaltrials.gov (No: NCT03656978 ). Registered 4 September 2018.",2020,"The posterior wall puncture rate was significantly lower (P = 0.002) in the DNTP group (29.2%) than in the AD group (56.1%; RR = 0.56, 95% CI: 0.42-0.82).
","['131 adult surgical patients', 'adults', 'adult surgical patients']","['Dynamic needle tip positioning versus the angle-distance technique for ultrasound-guided radial artery cannulation', 'DNTP and AD groups to undergo ultrasound-guided radial artery cannulation', 'DNTP', 'dynamic needle tip positioning (DNTP) technique versus the angle-distance (AD) technique for ultrasound-guided radial arterial cannulation']","['success rates without posterior wall puncture', 'first-pass success rate, 10-min overall success rate, cannulation time, posterior wall puncture, and the number of skin punctures', 'posterior wall puncture rate', 'success rates and incidences of complications', 'overall success rate', 'first-pass success without posterior wall puncture', 'cannulation time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442038', 'cui_str': 'Radial'}]","[{'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",131.0,0.203056,"The posterior wall puncture rate was significantly lower (P = 0.002) in the DNTP group (29.2%) than in the AD group (56.1%; RR = 0.56, 95% CI: 0.42-0.82).
","[{'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Bai', 'Affiliation': 'Department of Anaesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Anaesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Anaesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China. ychh@pumch.cn.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anaesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01152-1']
2569,31954959,Cognitive-behavioral-based physical therapy to enhance return to sport after anterior cruciate ligament reconstruction: An open pilot study.,"OBJECTIVES


To describe feasibility, adherence, acceptability, and outcomes of a cognitive-behavioral-based physical therapy (CBPT-ACLR) intervention for improving postoperative recovery after anterior cruciate ligament reconstruction (ACLR).
DESIGN


Pilot study.
SETTING


Academic medical center.
PARTICIPANTS


Eight patients (mean age [SD] = 20.1 [2.6] years, 6 females) participated in a 7-session telephone-based CBPT-ACLR intervention beginning preoperatively and lasting 8 weeks after surgery.
MAIN OUTCOME MEASURES


At 6 months, patients completed Knee Injury and Osteoarthritis Outcome Score (KOOS) sports/recreation and quality of life (QOL) subscales, International Knee Documentation Committee (IKDC), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), and Knee Self-Efficacy Scale (K-SES), return to sport (Subjective Patient Outcome for Return to Sports), and satisfaction. Minimal clinically important difference (MCID) was used for meaningful change.
RESULTS


Seven (88%) patients completed all sessions. Seven (88%) patients exceeded MCID on the TSK, 6 (75%) on the PCS, 5 (63%) on the KOOS sports/recreation subscale, 4 (50%) on the IKDC, and 3 (38%) on the KOOS QOL subscale. Three (38%) patients returned to their same sport at the same level of effort and performance. All patients were satisfied with their recovery.
CONCLUSIONS


A CBPT-ACLR program is feasible and acceptable for addressing psychological risk factors after ACLR.",2020,"Seven (88%) patients exceeded MCID on the TSK, 6 (75%) on the PCS, 5 (63%) on the KOOS sports/recreation subscale, 4 (50%) on the IKDC, and 3 (38%) on the KOOS QOL subscale.","['Academic medical center', 'Eight patients (mean age [SD]\xa0=\xa020.1 [2.6] years, 6 females) participated in a', 'after anterior cruciate ligament reconstruction (ACLR', 'anterior cruciate ligament reconstruction']","['7-session telephone-based CBPT-ACLR intervention beginning preoperatively and lasting 8 weeks after surgery', 'cognitive-behavioral-based physical therapy (CBPT-ACLR) intervention', 'Cognitive-behavioral-based physical therapy', 'CBPT-ACLR program']","['postoperative recovery', 'KOOS sports/recreation subscale', 'KOOS QOL subscale', 'Knee Injury and Osteoarthritis Outcome Score (KOOS) sports/recreation and quality of life (QOL) subscales, International Knee Documentation Committee (IKDC), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), and Knee Self-Efficacy Scale (K-SES), return to sport (Subjective Patient Outcome for Return to Sports), and satisfaction']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.019587,"Seven (88%) patients exceeded MCID on the TSK, 6 (75%) on the PCS, 5 (63%) on the KOOS sports/recreation subscale, 4 (50%) on the IKDC, and 3 (38%) on the KOOS QOL subscale.","[{'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Sterling', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Dana E', 'Initials': 'DE', 'LastName': 'Fenster', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Mackenzie L', 'Initials': 'ML', 'LastName': 'Bird', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Heritage', 'Affiliation': 'Department of Psychology, Vanderbilt University, Nashville, TN, USA; Department of Psychology, Counseling & Family Science, Lipscomb University, Nashville, TN, USA.'}, {'ForeName': 'Vickie L', 'Initials': 'VL', 'LastName': 'Woosley', 'Affiliation': 'Athletic Department, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Alda M', 'Initials': 'AM', 'LastName': 'Burston', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Huston', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Vanston', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Cox', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jaron P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kurt P', 'Initials': 'KP', 'LastName': 'Spindler', 'Affiliation': 'Department of Orthopaedic Surgery, The Cleveland Clinic Foundation, Cleveland, OH, USA.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA; Osher Center for Integrative Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: kristin.archer@vumc.org.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.01.004']
2570,30561539,"Controlled Human Malaria Infection of Healthy Adults With Lifelong Malaria Exposure to Assess Safety, Immunogenicity, and Efficacy of the Asexual Blood Stage Malaria Vaccine Candidate GMZ2.","BACKGROUND


GMZ2 is a recombinant malaria vaccine inducing immune responses against Plasmodium falciparum (Pf) merozoite surface protein-3 and glutamate-rich protein. We used standardized controlled human malaria infection (CHMI) to assess the efficacy of this asexual blood-stage vaccine.
METHODS


We vaccinated 50 healthy, adult volunteers with lifelong exposure to Pf 3 times, at 4-week intervals, with 30 or 100 µg GMZ2 formulated in CAF01, a liposome-based adjuvant; 100 µg GMZ2, formulated in Alhydrogel; or a control vaccine (Verorab). Approximately 13 weeks after the last vaccination, 35/50 volunteers underwent CHMI by direct venous inoculation of 3200 Pf sporozoites (Sanaria® PfSPZ Challenge).
RESULTS


Adverse events were similarly distributed between GMZ2 and control vaccinees. Baseline-corrected anti-GMZ2 antibody concentrations 4 weeks after the last vaccination were higher in all 3 GMZ2-vaccinated arms, compared to the control group. All GMZ2 formulations induced similar antibody levels. CHMI resulted in 29/34 (85%) volunteers with Pf parasitemia and 15/34 (44%) with malaria (parasitemia and symptoms). The proportion of participants with malaria (2/5 control, 6/10 GMZ2-Alhydrogel, 2/8 30 µg GMZ2-CAF01, and 5/11 100 µg GMZ2-CAF01) and the time it took them to develop malaria were similar in all groups. Baseline, vaccine-specific antibody concentrations were associated with protection against malaria.
CONCLUSIONS


GMZ2 is well tolerated and immunogenic in lifelong-Pf-exposed adults from Gabon, with similar antibody responses regardless of formulation. CHMI showed no protective effect of prior vaccination with GMZ2, although baseline, vaccine-specific antibody concentrations were associated with protection. CHMI with the PfSPZ Challenge is a potent new tool to validate asexual, blood-stage malaria vaccines in Africa.
CLINICAL TRIALS REGISTRATION


Pan-African Clinical Trials: PACTR201503001038304.",2019,"Baseline-corrected anti-GMZ2 antibody concentrations 4 weeks after the last vaccination were higher in all 3 GMZ2-vaccinated arms, compared to the control group.","['Healthy Adults', '35/50 volunteers underwent CHMI by direct venous inoculation of 3200', 'participants with malaria (2/5 control, 6/10 GMZ2-Alhydrogel, 2/8 30 µg GMZ2-CAF01, and 5/11 100 µg GMZ2-CAF01) and the', 'vaccinated 50 healthy, adult volunteers with lifelong exposure to Pf 3 times, at 4-week intervals, with 30 or 100 µg']","['GMZ2 formulated in CAF01, a liposome-based adjuvant; 100 µg GMZ2, formulated in Alhydrogel; or a control vaccine (Verorab', 'GMZ2']","['CHMI', 'time it took them to develop malaria', 'antibody levels', 'Safety, Immunogenicity, and Efficacy']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C4520513', 'cui_str': 'Exposure to Plasmodium falciparum'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0733770', 'cui_str': 'Alhydrogel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.0579818,"Baseline-corrected anti-GMZ2 antibody concentrations 4 weeks after the last vaccination were higher in all 3 GMZ2-vaccinated arms, compared to the control group.","[{'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Dejon-Agobe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Ulysse', 'Initials': 'U', 'LastName': 'Ateba-Ngoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lalremruata', 'Affiliation': 'Institut für Tropenmedizin, Universität Tübingen and German Center for Infection Research, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Homoet', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Engelhorn', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Odilon Paterne', 'Initials': 'OP', 'LastName': 'Nouatin', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Jean Ronald', 'Initials': 'JR', 'LastName': 'Edoa', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'José F', 'Initials': 'JF', 'LastName': 'Fernandes', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Yoanne Darelle', 'Initials': 'YD', 'LastName': 'Mouwenda', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Eunice M', 'Initials': 'EM', 'LastName': 'Betouke Ongwe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Massinga-Loembe', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria, Inc., Rockville, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Theisen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Denmark.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Ayôla A', 'Initials': 'AA', 'LastName': 'Adegnika', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Mordmüller', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné and African Partner Institution, German Center for Infection Research, Gabon.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1087']
2571,30753355,Transmission-blocking Effects of Primaquine and Methylene Blue Suggest Plasmodium falciparum Gametocyte Sterilization Rather Than Effects on Sex Ratio.,"Gametocyte density and sex ratio can predict the proportion of mosquitoes that will become infected after feeding on blood of patients receiving nongametocytocidal drugs. Because primaquine and methylene blue sterilize gametocytes before affecting their density and sex ratio, mosquito feeding experiments are required to demonstrate their early transmission-blocking effects.",2019,Gametocyte density and sex ratio can predict the proportion of mosquitoes that will become infected after feeding on blood of patients receiving nongametocytocidal drugs.,[],"['Primaquine and Methylene Blue Suggest Plasmodium falciparum Gametocyte Sterilization', 'primaquine and methylene blue sterilize gametocytes']","['Gametocyte density and sex ratio', 'Sex Ratio']",[],"[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C3662566', 'cui_str': 'Plasmodium falciparum gametocyte'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0686869', 'cui_str': 'Kingdom Protozoa gametocyte'}]","[{'cui': 'C0686869', 'cui_str': 'Kingdom Protozoa gametocyte'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}]",,0.0119824,Gametocyte density and sex ratio can predict the proportion of mosquitoes that will become infected after feeding on blood of patients receiving nongametocytocidal drugs.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Harouna M', 'Initials': 'HM', 'LastName': 'Soumaré', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Almahamoudou', 'Initials': 'A', 'LastName': 'Mahamar', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Halimatou', 'Initials': 'H', 'LastName': 'Diawara', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Roh', 'Affiliation': 'Global Health Group, Malaria Elimination Initiative, University of California, San Francisco.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Delves', 'Affiliation': 'Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Drakeley', 'Affiliation': 'Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Churcher', 'Affiliation': 'MRC Centre for Global Infectious Disease Analysis, Imperial College London, United Kingdom.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Mali.'}, {'ForeName': 'Roly', 'Initials': 'R', 'LastName': 'Gosling', 'Affiliation': 'Global Health Group, Malaria Elimination Initiative, University of California, San Francisco.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz134']
2572,30854904,Trochanteric spurs and surface irregularities on plain radiography are not predictive of greater trochanteric pain syndrome.,"PURPOSE


Surface irregularities of the greater trochanter have been described as a potential radiographic sign of greater trochanteric pain syndrome (GTPS). We report a diagnostic accuracy study to evaluate the clinical usefulness of trochanteric surface irregularities on plain radiographs in the diagnosis of GTPS.
METHODS


We retrospectively identified the anteroposterior pelvic radiographs of a consecutive group of 38 patients (representing a 27.5% series prevalence) diagnosed with GTPS (mean age 69.5 years ± 16.1 [standard deviation], 27 females, 11 males) based on clinical symptoms and a positive response to a local anaesthetic and steroid injection. A control group consisted of 100 patients (mean age 73 years ± 17.1 [standard deviation], 67 females, 33 males) with either hip osteoarthritis listed for hip arthroplasty ( n  = 50), or with an intracapsular neck of femur fracture ( n  = 50) both presenting between January and July 2017. Radiographs were cropped to blind observers to the presence of hip osteoarthritis or intracapsular fracture but included the trochanteric region. The radiograph sequence was randomised and separately presented to 3 orthopaedic surgeons to evaluate the presence of trochanteric surface irregularities.
RESULTS


The inter-observer correlation coefficient agreement was acceptable at 0.75 (95% CI, 0.60-0.84). Trochanteric surface irregularities including frank spurs protruding ⩾2 mm were associated with a 24.7% positive predictive value, 64.0% sensitivity, 25.7% specificity, 74.3% false-positive rate, 36.0% false-negative rate, and a 65.3% negative predictive value for clinical GTPS.
CONCLUSION


Surface irregularities of the greater trochanter are not reliable radiographic indicators for the diagnosis of greater trochanteric pain syndrome.",2020,"CONCLUSION


Surface irregularities of the greater trochanter are not reliable radiographic indicators for the diagnosis of greater trochanteric pain syndrome.","['100 patients ', 'mean age 73\u2009years ± 17.1 [standard deviation], 67 females, 33 males) with either hip osteoarthritis listed for hip arthroplasty ( n  = 50), or with an intracapsular neck of femur fracture ( n  = 50) both presenting between January and July 2017', '38 patients (representing a 27.5% series prevalence) diagnosed with GTPS (mean age 69.5\u2009years ± 16.1 [standard deviation], 27 females, 11 males) based on clinical symptoms and a positive response to a local anaesthetic and steroid injection']",['plain radiography'],['trochanteric pain syndrome'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0391976', 'cui_str': 'Pain Disorder'}]",,0.0314211,"CONCLUSION


Surface irregularities of the greater trochanter are not reliable radiographic indicators for the diagnosis of greater trochanteric pain syndrome.","[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Barrett', 'Affiliation': 'Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, UK.'}, {'ForeName': 'Eve E', 'Initials': 'EE', 'LastName': 'Robertson-Waters', 'Affiliation': 'Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Whitehouse', 'Affiliation': 'Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, UK.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Blom', 'Affiliation': 'Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Berstock', 'Affiliation': 'Musculoskeletal Research Unit, Bristol Medical School, University of Bristol, UK.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700019835641']
2573,30882137,Antibiotic Therapy for Pseudomonas aeruginosa Bloodstream Infections: How Long Is Long Enough?,"In a multicenter, observational, propensity-score-weighted cohort of 249 adults with uncomplicated Pseudomonas aeruginosa bacteremia, patients receiving short-course (median, 9 days; interquartile range [IQR], 8-10) therapy had a similar odds of recurrent infection or death within 30 days as those receiving longer courses (median, 16 days; IQR, 14-17).",2019,"In a multicenter, observational, propensity-score-weighted cohort of 249 adults with uncomplicated Pseudomonas aeruginosa bacteremia, patients receiving short-course (median, 9 days; interquartile range [IQR], 8-10) therapy had a similar odds of recurrent infection or death within 30 days as those receiving longer courses (median, 16 days; IQR, 14-17).","['249 adults with uncomplicated Pseudomonas aeruginosa bacteremia, patients receiving short-course (median, 9 days; interquartile range [IQR], 8-10) therapy had a similar odds of recurrent infection or death within 30 days as those receiving longer courses (median, 16 days; IQR, 14-17', 'Pseudomonas aeruginosa Bloodstream Infections']",['Antibiotic Therapy'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],249.0,0.162282,"In a multicenter, observational, propensity-score-weighted cohort of 249 adults with uncomplicated Pseudomonas aeruginosa bacteremia, patients receiving short-course (median, 9 days; interquartile range [IQR], 8-10) therapy had a similar odds of recurrent infection or death within 30 days as those receiving longer courses (median, 16 days; IQR, 14-17).","[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Fabre', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Amoah', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Cosgrove', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Pranita D', 'Initials': 'PD', 'LastName': 'Tamma', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz223']
2574,31062260,Association Between Statin Use and Depressive Symptoms in a Large Community-Dwelling Older Population Living in Australia and the USA: A Cross-Sectional Study.,"BACKGROUND


Statin use has been frequently associated with depressive symptoms in an older population. However, the nature of this association is uncertain in the literature. In this study, we aimed to investigate the association of statin intake and the prevalence of depressive symptoms in healthy community-dwelling older adults living in Australia and the USA.
METHODS


We analysed baseline data from 19,114 participants, over 70 years of age (over 65 years of age, if from an ethnic minority). The association of self-reported statin use and prevalence of depressive symptoms, as measured by a validated depression scale [Center for Epidemiological Studies Depression Scale (CES-D 10)], was determined using logistic regression models. Multivariable logistic models were implemented to account for important demographics and other lifestyle and socioeconomic factors, such as sex, age, living status, education and smoking history.
RESULTS


A total of 5987 individuals were statin users. Of those, 633 (10.6%) had depressive symptoms (CES-D 10 cut-off ≥ 8), compared with 1246 (9.5%) of the non-statin users. In the unadjusted model, statin use was associated with an increase in prevalence of depressive symptoms (odds ratio 1.13, confidence interval 1.02-1.25, p = 0.02). However, after adjusting for important demographic and socioeconomic factors, the use of statins was not significantly associated with depressive symptoms (odds ratio 1.09, confidence interval 0.98-1.20, p = 0.11). In secondary analyses, only simvastatin was marginally associated with an increased prevalence of depressive symptoms. Statins were associated with a decreased prevalence of depressive symptoms in individuals with severe obesity (body mass index > 35 kg/m 2 ) and an increased prevalence in participants between 75 and 84 years of age.
CONCLUSION


This study in a large community-dwelling older population did not show any association of statins with late-life depressive symptoms, after accounting for important socioeconomic and demographic factors. Confounding by indication is an important issue to be addressed in future pharmacoepidemiologic studies of statins.",2019,"In the unadjusted model, statin use was associated with an increase in prevalence of depressive symptoms (odds ratio 1.13, confidence interval 1.02-1.25, p = 0.02).","['participants between 75 and 84\xa0years of age', '35\xa0kg', '19,114 participants, over 70\xa0years of age (over 65\xa0years of age, if from an ethnic minority', 'Large Community-Dwelling Older Population Living in Australia and the USA', '5987 individuals were statin users', 'individuals with severe obesity (body mass index ', 'healthy community-dwelling older adults living in Australia and the USA', 'large community-dwelling older population']",['simvastatin'],"['prevalence of depressive symptoms', 'depressive symptoms']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",5987.0,0.161328,"In the unadjusted model, statin use was associated with an increase in prevalence of depressive symptoms (odds ratio 1.13, confidence interval 1.02-1.25, p = 0.02).","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Agustini', 'Affiliation': 'IMPACT Strategic Research Centre (Innovation in Mental and Physical Health and Clinical Treatment Strategic Research Centre), School of Medicine, Deakin University, PO Box 281, Geelong, VIC, 3220, Australia. bagustini@deakin.edu.au.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'IMPACT Strategic Research Centre (Innovation in Mental and Physical Health and Clinical Treatment Strategic Research Centre), School of Medicine, Deakin University, PO Box 281, Geelong, VIC, 3220, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, MN, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, The University of Iowa, Iowa, IO, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tonkin', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'IMPACT Strategic Research Centre (Innovation in Mental and Physical Health and Clinical Treatment Strategic Research Centre), School of Medicine, Deakin University, PO Box 281, Geelong, VIC, 3220, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CNS drugs,['10.1007/s40263-019-00633-3']
2575,31291159,Phonation Demonstrates Goal Dependence Under Unique Vocal Intensity and Aerobic Workload Conditions.,"Purpose This study investigated whether metabolic respiratory requirements (treadmill workload) affected glottal valving in phonation, based on aerodynamic measures, when a sound pressure level (vocal SPL) is dictated as a target goal. Consistent with a theory of action, we hypothesized that adjustments in glottal valving as measured by laryngeal airway resistance would be dependent upon vocal SPL level, even as workload increased, and loud vocal SPL would interfere more with respiratory homeostasis than spontaneous vocal SPL. Method Thirty-two women enrolled who were ages 18-35 years. A repeated-measures design was used with random assignment of workload and vocal SPL conditions. Aerodynamic and acoustic data were collected during phonation, as were gas volume and concentration data. Analyses were performed with generalized estimating equations. Results Laryngeal airway resistance at a low workload significantly increased when vocal SPL changed from spontaneous to loud. At a loud vocal SPL, laryngeal airway resistance decreased when workload changed from rest to either low or high. Regarding the respiratory system response, minute ventilation increased at a loud vocal SPL when workload changed from rest to either low or high. End-tidal CO 2  increased under low and high workloads relative to rest at loud and spontaneous vocal SPLs. Conclusions Mostly consistent with a theory of action, in which motor control is goal dependent (i.e., vocal SPL targets), speakers can achieve a loud vocal SPL despite increases in workload requirements. In contrast, laryngeal airway resistance stays relatively low when vocal SPL occurs spontaneously, suggesting glottal adjustments are made to improve gas exchange as metabolic respiratory requirements become prioritized. Metabolic respiratory requirements appear to be overcome by the overlay of motor control for voicing when a loud vocal SPL is targeted. The implication of goal-dependent phonation for clinicians is that real-world conditions (i.e., loud vocal SPL) matter in vocal testing and voice therapy.",2019,Metabolic respiratory requirements appear to be overcome by the overlay of motor control for voicing when a loud vocal SPL is targeted.,['Method Thirty-two women enrolled who were ages 18-35 years'],[],"['Laryngeal airway resistance', 'Aerodynamic and acoustic data', 'vocal SPL', 'loud vocal SPL, laryngeal airway resistance', 'End-tidal CO 2  increased under low and high workloads relative to rest at loud and spontaneous vocal SPLs']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C3873831', 'cui_str': 'Laryngeal airway'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",32.0,0.0204969,Metabolic respiratory requirements appear to be overcome by the overlay of motor control for voicing when a loud vocal SPL is targeted.,"[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ziegler', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'VanSwearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, PA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health & Physical Activity, University of Pittsburgh, PA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Verdolini Abbott', 'Affiliation': 'University of Delaware, Dover.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-S-18-0126']
2576,31343936,The Relationship Between Language and Planning in Children With Language Impairment.,"Purpose This study examined the relationship between language and planning, a higher order executive function skill, in children with specific language impairment (SLI) and typically developing (TD) children. We hypothesized differences between groups in planning performance and in the role of verbal mediation during planning. Method Thirty-one children with SLI and 50 TD age-matched peers (8-12 years) participated in the study. We assessed language ability via a standardized language measure and planning via a dual-task Tower of London paradigm with 3 conditions: no secondary task (baseline), articulatory suppression secondary task (disrupted verbal mediation), and motor suppression secondary task (control for secondary task demand). Results We found similar overall accuracy between children with SLI and TD peers on the Tower of London. Children with SLI executed trials more slowly at baseline than TD peers but not under articulatory suppression, and children with SLI spent less time planning than TD children at baseline and under articulatory suppression. There was a significant interaction among group, language ability, and planning time under articulatory suppression. Children with SLI who had relatively better language ability spent less time planning than children with SLI who had poorer language ability when verbal mediation was disrupted. This pattern was reversed for TD children. Conclusions This study provides evidence for a relationship between language and planning, yet this relationship differed between children with SLI compared to TD peers. Findings suggest that children with SLI use nonlinguistic perceptual strategies to a greater degree than verbal strategies on visuospatial planning tasks and that intervention might address strategy use for planning.",2019,Children with SLI who had relatively better language ability spent less time planning than children with SLI who had poorer language ability when verbal mediation was disrupted.,"['children with SLI compared to TD peers', 'Method Thirty-one children with SLI and 50 TD age-matched peers (8-12 years) participated in the study', 'Children With Language Impairment', 'children with SLI and TD peers on the Tower of London', 'Children with SLI who had relatively better', 'children with specific language impairment (SLI) and typically developing (TD) children']","['standardized language measure and planning via a dual-task Tower of London paradigm with 3 conditions: no secondary task (baseline), articulatory suppression secondary task (disrupted verbal mediation), and motor suppression secondary task (control for secondary task demand']","['language ability, and planning time under articulatory suppression', 'language ability spent less time planning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454651', 'cui_str': 'Specific language impairment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023015', 'cui_str': 'Disorder of language'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",31.0,0.0379442,Children with SLI who had relatively better language ability spent less time planning than children with SLI who had poorer language ability when verbal mediation was disrupted.,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Larson', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}, {'ForeName': 'Ishanti', 'Initials': 'I', 'LastName': 'Gangopadhyay', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Kaushanskaya', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}, {'ForeName': 'Susan Ellis', 'Initials': 'SE', 'LastName': 'Weismer', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Wisconsin-Madison.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-L-18-0367']
2577,31344386,Targeting the Cutaneous Microbiota in Atopic Dermatitis by Coal Tar via AHR-Dependent Induction of Antimicrobial Peptides.,"Skin colonization by Staphylococcus aureus and its relative abundance is associated with atopic dermatitis (AD) disease severity and treatment response. Low levels of antimicrobial peptides in AD skin may be related to the microbial dysbiosis. Therapeutic targeting of the skin microbiome and antimicrobial peptide expression can, therefore, restore skin homeostasis and combat AD. In this study, we analyzed the cutaneous microbiome composition in 7 patients with AD and 10 healthy volunteers upon topical coal tar or vehicle treatment. We implemented and validated a Staphylococcus-specific single-locus sequence typing approach combined with classic 16S ribosomal RNA marker gene sequencing to study the bacterial composition. During coal tar treatment, Staphylococcus abundance decreased, and Propionibacterium abundance increased, suggesting a shift of the microbiota composition toward that of healthy controls. We, furthermore, identified a hitherto unknown therapeutic mode of action of coal tar, namely the induction of keratinocyte-derived antimicrobial peptides via activation of the aryl hydrocarbon receptor. Restoring antimicrobial peptide levels in AD skin via aryl hydrocarbon receptor-dependent transcription regulation can be beneficial by creating a (anti)microbial milieu that is less prone to infection and inflammation. This underscores the importance of coal tar in the therapeutic aryl hydrocarbon receptor armamentarium and highlights the aryl hydrocarbon receptor as a target for drug development.",2020,"During coal tar treatment, Staphylococcus abundance decreased, and Propionibacterium abundance increased, suggesting a shift of the microbiota composition toward that of healthy controls.",['7 patients with AD and 10 healthy volunteers upon topical coal tar or vehicle treatment'],[],"['Staphylococcus abundance decreased, and Propionibacterium abundance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0009137', 'cui_str': 'Coal Tar'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033476', 'cui_str': 'Propionibacterium'}]",7.0,0.0286973,"During coal tar treatment, Staphylococcus abundance decreased, and Propionibacterium abundance increased, suggesting a shift of the microbiota composition toward that of healthy controls.","[{'ForeName': 'Jos P H', 'Initials': 'JPH', 'LastName': 'Smits', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Thomas H A', 'Initials': 'THA', 'LastName': 'Ederveen', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands; Center for Molecular and Biomolecular Informatics, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands; NIZO, Ede, The Netherlands.'}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Rikken', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Noa J M', 'Initials': 'NJM', 'LastName': 'van den Brink', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Ivonne M J J', 'Initials': 'IMJJ', 'LastName': 'van Vlijmen-Willems', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Boekhorst', 'Affiliation': 'Center for Molecular and Biomolecular Informatics, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands; NIZO, Ede, The Netherlands.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Kamsteeg', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Schalkwijk', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Sacha A F T', 'Initials': 'SAFT', 'LastName': 'van Hijum', 'Affiliation': 'Center for Molecular and Biomolecular Informatics, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands; NIZO, Ede, The Netherlands.'}, {'ForeName': 'Patrick L J M', 'Initials': 'PLJM', 'LastName': 'Zeeuwen', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'van den Bogaard', 'Affiliation': 'Department of Dermatology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: ellen.vandenbogaard@radboudumc.nl.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2019.06.142']
2578,31420399,Reliability of a wearable wireless patch for continuous remote monitoring of vital signs in patients recovering from major surgery: a clinical validation study from the TRaCINg trial.,"OBJECTIVE


To validate whether a wearable remote vital signs monitor could accurately measure heart rate (HR), respiratory rate (RR) and temperature in a postsurgical patient population at high risk of complications.
DESIGN


Manually recorded vital signs data were paired with vital signs data derived from the remote monitor set in patients participating in the Trial of Remote versus Continuous INtermittent monitoring (TRaCINg) study: a trial of continuous remote vital signs monitoring.
SETTING


St James's University Hospital, UK.
PARTICIPANTS


51 patients who had undergone major elective general surgery.
INTERVENTIONS


The intervention was the SensiumVitals monitoring system. This is a wireless patch worn on the patient's chest that measures HR, RR and temperature continuously. The reference standard was nurse-measured manually recorded vital signs.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcomes were the 95% limits of agreement between manually recorded and wearable patch vital sign recordings of HR, RR and temperature. The secondary outcomes were the percentage completeness of vital sign patch data for each vital sign.
RESULTS


1135 nurse observations were available for analysis. There was no clinically meaningful bias in HR (1.85 bpm), but precision was poor (95% limits of agreement -23.92 to 20.22 bpm). Agreement was poor for RR (bias 2.93 breaths per minute, 95% limits of agreement -8.19 to 14.05 breaths per minute) and temperature (bias 0.82 ° C, 95% limits of agreement -1.13 ° C to 2.78 ° C). Vital sign patch data completeness was 72.8% for temperature, 59.2% for HR and 34.1% for RR. Distributions of RR in manually recorded measurements were clinically implausible.
CONCLUSIONS


The continuous monitoring system did not reliably provide HR consistent with nurse measurements. The accuracy of RR and temperature was outside of acceptable limits. Limitations of the system could potentially be overcome through better signal processing. While acknowledging the time pressures placed on nursing staff, inaccuracies in the manually recorded data present an opportunity to increase awareness about the importance of manual observations, particularly with regard to methods of manual HR and RR measurements.",2019,"Agreement was poor for RR (bias 2.93 breaths per minute, 95% limits of agreement -8.19 to 14.05 breaths per minute) and temperature (bias 0.82 ° C, 95% limits of agreement -1.13","[""St James's University Hospital, UK"", 'patients recovering from major surgery', '51 patients who had undergone major elective general surgery']","['wearable wireless patch', 'continuous remote vital signs monitoring']","['Vital sign patch data completeness', '95% limits of agreement between manually recorded and wearable patch vital sign recordings of HR, RR and temperature', 'heart rate (HR), respiratory rate (RR) and temperature', 'accuracy of RR and temperature', 'percentage completeness of vital sign patch data for each vital sign']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C2739811', 'cui_str': 'Monitoring of blood pressure, temperature, pulse rate and respiratory rate'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",51.0,0.0721945,"Agreement was poor for RR (bias 2.93 breaths per minute, 95% limits of agreement -8.19 to 14.05 breaths per minute) and temperature (bias 0.82 ° C, 95% limits of agreement -1.13","[{'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Downey', 'Affiliation': ""Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK c.l.downey@leeds.ac.uk.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': ""Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Centre for Health Informatics, University of Manchester, Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2019-031150']
2579,31465533,Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study.,"OBJECTIVES


Many patients with Cushing's disease (CD) require chronic pharmacotherapy to control their hypercortisolism. We evaluated the efficacy and safety of long-acting pasireotide during a long-term extension study in patients with CD.
DESIGN


Open-label extension to a 12-month Phase III study of long-acting pasireotide in CD (N = 150; NCT01374906).
PATIENTS


Patients with mean urinary free cortisol (mUFC) ≤ upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension.
RESULTS


Eighty-one of 150 (54.0%) enrolled patients entered the extension. Median overall exposure to pasireotide at study end was 23.9 months; 39/81 (48.1%) patients completed the extension (received ≥ 12 months' treatment during the extension and could transit to a separate pasireotide safety study). mUFC was ≤ULN in 42/81 (51.9%), 13/81 (16.0%) and 43/81 (53.1%) patients at extension baseline, month (M) 36 and last assessment. Median mUFC remained within normal limits. Median late-night salivary cortisol was 2.6 × ULN at core baseline and 1.3 × ULN at M36. Clinical improvements were sustained over time. Forty-two (51.9%) patients discontinued during the extension: 25 (30.9%) before M24 and 17 (21.0%) after M24. Hyperglycaemia-related AEs occurred in 39.5% of patients. Mean fasting glucose (FPG) and glycated haemoglobin (HbA 1c  ) were stable during the extension, with antidiabetic medication initiated/escalated in some patients. Sixty-six (81.5%) and 71 (88.9%) patients were classified as having diabetes (HbA 1c   ≥ 6.5%, FPG ≥ 7.0 mmol/L, antidiabetic medication use, or history of diabetes) at extension baseline and last assessment.
CONCLUSIONS


Long-acting pasireotide provided sustained biochemical and clinical improvements, with no new safety signals emerging, supporting its use as an effective long-term therapy for CD.",2019,Median late-night salivary cortisol was 2.6 × ULN at core baseline and 1.3 × ULN at M36.,"['Patients with mean urinary free cortisol (mUFC)\xa0≤\xa0upper limit of normal (ULN) or receiving clinical benefit at core study end could continue long-acting pasireotide during the extension', ""patients with Cushing's disease (CD) require chronic pharmacotherapy to control their hypercortisolism"", 'Sixty-six (81.5%) and 71 (88.9%) patients were classified as having diabetes (HbA 1c', 'patients with CD', 'Eighty-one of 150 (54.0%) enrolled patients entered the extension', ""Cushing's disease""]",[],"['Median mUFC', 'Median late-night salivary cortisol', 'efficacy and safety', 'Hyperglycaemia-related AEs', 'Mean fasting glucose (FPG) and glycated haemoglobin', 'mUFC', 'FPG\xa0≥']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001622', 'cui_str': 'Hypercortisolism'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0159183,Median late-night salivary cortisol was 2.6 × ULN at core baseline and 1.3 × ULN at M36.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Northwest Pituitary Center, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Petersenn', 'Affiliation': 'ENDOC Center for Endocrine Tumors, Hamburg, Germany.'}, {'ForeName': 'Beverly M K', 'Initials': 'BMK', 'LastName': 'Biller', 'Affiliation': 'Massachussetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Kadioglu', 'Affiliation': 'Pituitary Center, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'De Block', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': ""T'Sjoen"", 'Affiliation': 'Department of Endocrinology and Center for Sexology and Gender, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Vantyghem', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, CHU Lille, Lille, France.'}, {'ForeName': 'Libuse', 'Initials': 'L', 'LastName': 'Tauchmanova', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Wojna', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roughton', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': ""Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Newell-Price', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}]",Clinical endocrinology,['10.1111/cen.14081']
2580,31484076,β-Glucan-Induced Trained Immunity Protects against Leishmania braziliensis Infection: a Crucial Role for IL-32.,"American tegumentary leishmaniasis is a vector-borne parasitic disease caused by Leishmania protozoans. Innate immune cells undergo long-term functional reprogramming in response to infection or Bacillus Calmette-Guérin (BCG) vaccination via a process called trained immunity, conferring non-specific protection from secondary infections. Here, we demonstrate that monocytes trained with the fungal cell wall component β-glucan confer enhanced protection against infections caused by Leishmania braziliensis through the enhanced production of proinflammatory cytokines. Mechanistically, this augmented immunological response is dependent on increased expression of interleukin 32 (IL-32). Studies performed using a humanized IL-32 transgenic mouse highlight the clinical implications of these findings in vivo. This study represents a definitive characterization of the role of IL-32γ in the trained phenotype induced by β-glucan or BCG, the results of which improve our understanding of the molecular mechanisms governing trained immunity and Leishmania infection control.",2019,"Here, we demonstrate that monocytes trained with the fungal cell wall component β-glucan confer enhanced protection against infections caused by Leishmania braziliensis through the enhanced production of proinflammatory cytokines.",[],"['β-Glucan-Induced Trained Immunity', 'Bacillus Calmette-Guérin (BCG) vaccination']",[],[],"[{'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.0190885,"Here, we demonstrate that monocytes trained with the fungal cell wall component β-glucan confer enhanced protection against infections caused by Leishmania braziliensis through the enhanced production of proinflammatory cytokines.","[{'ForeName': 'Jéssica Cristina', 'Initials': 'JC', 'LastName': 'Dos Santos', 'Affiliation': 'Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands; Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Ana Marina', 'Initials': 'AM', 'LastName': 'Barroso de Figueiredo', 'Affiliation': 'Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Muriel Vilela', 'Initials': 'MV', 'LastName': 'Teodoro Silva', 'Affiliation': 'Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Cirovic', 'Affiliation': 'Myeloid Cell Biology, Life and Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.'}, {'ForeName': 'L Charlotte J', 'Initials': 'LCJ', 'LastName': 'de Bree', 'Affiliation': 'Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands; Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; Odense Patient Data Explorative Network, University of Southern Denmark and Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Michelle S M A', 'Initials': 'MSMA', 'LastName': 'Damen', 'Affiliation': ""Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands; Division of Immunobiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Simone J C F M', 'Initials': 'SJCFM', 'LastName': 'Moorlag', 'Affiliation': 'Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Rodrigo S', 'Initials': 'RS', 'LastName': 'Gomes', 'Affiliation': 'Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Monique M', 'Initials': 'MM', 'LastName': 'Helsen', 'Affiliation': 'Department of Rheumatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Oosting', 'Affiliation': 'Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Keating', 'Affiliation': 'Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schlitzer', 'Affiliation': 'Myeloid Cell Biology, Life and Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany; Single Cell Genomics and Epigenomics Unit at the German Center for Neurodegenerative Diseases and the University of Bonn, 53175 Bonn, Germany.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands; Department for Genomics and Immunoregulation, Life and Medical Sciences Institute (LIMES), University of Bonn, Germany.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Ribeiro-Dias', 'Affiliation': 'Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Goiás, Brazil. Electronic address: fatimardias@gmail.com.'}, {'ForeName': 'Leo A B', 'Initials': 'LAB', 'LastName': 'Joosten', 'Affiliation': 'Radboud Institute for Molecular Sciences (RILMS), Department of Internal Medicine and Radboud Center of Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, the Netherlands; Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, Goiás, Brazil. Electronic address: leo.joosten@radboudumc.nl.'}]",Cell reports,['10.1016/j.celrep.2019.08.004']
2581,32295509,Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial.,"Background and Purpose- Emboli in embolic stroke of undetermined source (ESUS) may originate from various potential embolic sources (PES), some of which may respond better to anticoagulation, whereas others to antiplatelets. We analyzed whether rivaroxaban is associated with reduction of recurrent stroke compared with aspirin in patients with ESUS across different PES and by number of PES. Methods- We assessed the presence/absence of each PES (atrial cardiopathy, atrial fibrillation, arterial atherosclerosis, left ventricular dysfunction, cardiac valvulopathy, patent foramen ovale, cancer) in NAVIGATE-ESUS (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial Versus ASA to Prevent Embolism in Embolic Stroke of Undetermined Source) participants. Prevalence of each PES, as well as treatment effect and risk of event for each PES were determined. Results by number of PES were also determined. The outcomes were ischemic stroke, all-cause mortality, cardiovascular mortality, and myocardial infarction. Results- In 7213 patients (38% women, mean age 67years) followed for a median of 11 months, the 3 most prevalent PES were atrial cardiopathy (37%), left ventricular disease (36%), and arterial atherosclerosis (29%). Forty-one percent of all patients had multiple PES, with 15% having ≥3 PES. None or a single PES was present in 23% and 36%, respectively. Recurrent ischemic stroke risk was similar for rivaroxaban- and aspirin-assigned patients for each PES, except for those with cardiac valvular disease which was marginally higher in rivaroxaban-assigned patients (hazard ratio, 1.8 [95% CI, 1.0-3.0]). All-cause mortality risks were similar across treatment groups for each PES while too few myocardial infarctions and cardiovascular deaths occurred for meaningful assessment. Increasing number of PES was not associated with increased stroke recurrence nor all-cause mortality, and outcomes did not vary between rivaroxaban- and aspirin-assigned patients by number of PES. Conclusions- A large proportion of patients with ESUS had multiple PES which could explain the neutral results of NAVIGATE-ESUS. Recurrence rates between rivaroxaban- and aspirin-assigned patients were similar across the spectrum of PES. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02313909.",2020,All-cause mortality risks were similar across treatment groups for each PES while too few myocardial infarctions and cardiovascular deaths occurred for meaningful assessment.,"['7213 patients (38% women, mean age 67years) followed for a median of 11 months, the 3 most prevalent PES were atrial cardiopathy (37%), left ventricular disease (36%), and arterial atherosclerosis (29', 'patients with ESUS across different PES and by number of PES']","['rivaroxaban', 'Conclusions', 'rivaroxaban- and aspirin', 'Methods', 'aspirin']","['presence/absence of each PES (atrial cardiopathy, atrial fibrillation, arterial atherosclerosis, left ventricular dysfunction, cardiac valvulopathy, patent foramen ovale, cancer', 'stroke recurrence', 'cardiac valvular disease', 'Recurrent ischemic stroke risk', 'mortality risks', 'cardiovascular deaths', 'ischemic stroke, all-cause mortality, cardiovascular mortality, and myocardial infarction', 'Recurrence rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",7213.0,0.243519,All-cause mortality risks were similar across treatment groups for each PES while too few myocardial infarctions and cardiovascular deaths occurred for meaningful assessment.,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Ntaios', 'Affiliation': 'From the Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece (G.N.).'}, {'ForeName': 'Lesly A', 'Initials': 'LA', 'LastName': 'Pearce', 'Affiliation': 'Biostatistics Consultant, Minot, ND (L.A.P.).'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': 'Imperial College London, United Kingdom (R.V., E.K.).'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, ON, Canada (M.S., R.G.H.).'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia (S.E.K.).'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Korompoki', 'Affiliation': 'Imperial College London, United Kingdom (R.V., E.K.).'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Milionis', 'Affiliation': 'Department of Internal Medicine, University of Ioannina, Greece (H.M.).'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany (H.M.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Pharmaceuticals Clinical Development Thrombosis, NJ (S.D.B.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Medicine (Cardiology), McMaster University/Population Health Research Institute, Hamilton, ON, Canada (S.J.C.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, ON, Canada (M.S., R.G.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028669']
2582,32390550,Endovascular Treatment for Acute Ischemic Stroke in Patients on Oral Anticoagulants: Results From the MR CLEAN Registry.,"Background and Purpose- The use of oral anticoagulants (OAC) is considered a contra-indication for intravenous thrombolytics as acute treatment of ischemic stroke. However, little is known about the risks and benefits of endovascular treatment in patients on prior OAC. We aim to compare outcomes after endovascular treatment between patients with and without prior use of OAC. Methods- Data of patients with acute ischemic stroke caused by an intracranial anterior circulation occlusion, included in the nationwide, prospective, MR CLEAN Registry between March 2014 and November 2017, were analyzed. Outcomes of interest included symptomatic intracranial hemorrhage and functional outcome at 90 days (modified Rankin Scale score). Outcomes between groups were compared with (ordinal) logistic regression analyses, adjusted for prognostic factors. Results- Three thousand one hundred sixty-two patients were included in this study, of whom 502 (16%) used OAC. There was no significant difference in the occurrence of symptomatic intracranial hemorrhage between patients with and without prior OACs (5% versus 6%; adjusted odds ratio, 0.63 [95% CI, 0.38-1.06]). Patients on OACs had worse functional outcomes than patients without OACs (common odds ratio, 0.57 [95% CI, 0.47-0.66]). However, this observed difference in functional outcome disappeared after adjustment for prognostic factors (adjusted common odds ratio, 0.91 [95% CI, 0.74-1.13]). Conclusions- Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use. Therefore, prior OAC use should not be a contra-indication for endovascular treatment.",2020,Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use.,"['patients on prior OAC', 'patients with and without prior use of OAC', 'Acute Ischemic Stroke in Patients on Oral Anticoagulants', 'patients with acute ischemic stroke caused by an intracranial anterior circulation occlusion, included in the nationwide, prospective, MR CLEAN Registry between March 2014 and November 2017, were analyzed', 'Three thousand one hundred sixty-two patients were included in this study, of whom 502 (16%) used OAC']","[' and Purpose', 'Endovascular Treatment', 'Conclusions', 'oral anticoagulants (OAC']","['occurrence of symptomatic intracranial hemorrhage', 'symptomatic intracranial hemorrhage and functional outcome at 90 days (modified Rankin Scale score', 'functional outcomes', 'risk of symptomatic intracranial hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517705', 'cui_str': '3100'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3162.0,0.0786105,Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use.,"[{'ForeName': 'Robert-Jan B', 'Initials': 'RB', 'LastName': 'Goldhoorn', 'Affiliation': 'From the Department of Neurology (R.-J.B.G., W.H.H., R.J. v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'van Rees', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health (H.F.L.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'Hinsenveld', 'Affiliation': 'Department of Radiology (A.P., W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Postma', 'Affiliation': 'Department of Radiology (A.P., W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'van den Wijngaard', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, The Hague (I.v.d.W.).'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'From the Department of Neurology (R.-J.B.G., W.H.H., R.J. v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'From the Department of Neurology (R.-J.B.G., W.H.H., R.J. v.O.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology (R.A.v.d.G., J.M.v.R., D.W.J.D., B.R.), Erasmus MC, University Medical Center, Rotterdam.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028675']
2583,32404040,Stroke Etiology and Thrombus Computed Tomography Characteristics in Patients With Acute Ischemic Stroke: A MR CLEAN Registry Substudy.,"Background and Purpose- If a relationship between stroke etiology and thrombus computed tomography characteristics exists, assessing these characteristics in clinical practice could serve as a useful additional diagnostic tool for the identification of stroke subtype. Our purpose was to study the association of stroke etiology and thrombus computed tomography characteristics in patients with acute ischemic stroke due to a large vessel occlusion. Methods- For 1429 consecutive patients enrolled in the MR CLEAN Registry, we determined stroke cause as defined by the TOAST (Trial of ORG 10172 in Acute Stroke Treatment) criteria. The association of stroke etiology with the hyperdense artery sign, clot burden score, and thrombus location was estimated with univariable and multivariable binary and ordinal logistic regression. Additionally, for 367 patients with available thin-section imaging, we assessed the association of stroke etiology with absolute and relative thrombus attenuation, distance from internal carotid artery-terminus to thrombus, thrombus length, and thrombus attenuation increase with univariable and multivariable linear regression. Results- Compared with cardioembolic strokes, noncardioembolic strokes were associated with presence of hyperdense artery sign (odds ratio, 2.2 [95% CI, 1.6-3.0]), lower clot burden score (common odds ratio, 0.4 [95% CI, 0.3-0.6]), shift towards a more proximal thrombus location (common odds ratio, 0.2 [95% CI, 0.2-0.3]), higher absolute thrombus attenuation (β, 3.6 [95% CI, 0.9-6.4]), decrease in distance from the ICA-terminus (β, -5.7 [95% CI, -8.3 to -3.0]), and longer thrombi (β, 8.6 [95% CI, 6.5-10.7]), based on univariable analysis. Thrombus characteristics of strokes with undetermined cause were similar to those of cardioembolic strokes. Conclusions- Thrombus computed tomography characteristics of cardioembolic stroke are distinct from those of noncardioembolic stroke. Additionally, our study supports the general hypothesis that many cryptogenic strokes have a cardioembolic cause. Further research should focus on the use of thrombus computed tomography characteristics as a diagnostic tool for stroke cause in clinical practice.",2020,Thrombus characteristics of strokes with undetermined cause were similar to those of cardioembolic strokes.,"['Patients With Acute Ischemic Stroke', 'patients with acute ischemic stroke due to a large vessel occlusion', '1429 consecutive patients enrolled in the MR CLEAN Registry, we determined stroke cause as defined by the TOAST (Trial of ORG 10172 in Acute Stroke Treatment) criteria', '367 patients with available thin-section imaging']","[' and Purpose', 'Methods']","['proximal thrombus location', 'lower clot burden score', 'noncardioembolic strokes', 'stroke etiology with absolute and relative thrombus attenuation, distance from internal carotid artery-terminus to thrombus, thrombus length']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0069610', 'cui_str': 'Org 10172'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0026040', 'cui_str': 'Thin Sectioning'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",367.0,0.209541,Thrombus characteristics of strokes with undetermined cause were similar to those of cardioembolic strokes.,"[{'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Boodt', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (N.B., K.C.J.C., N.S., A.v.d.L.), Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Kars C J', 'Initials': 'KCJ', 'LastName': 'Compagne', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (N.B., K.C.J.C., N.S., A.v.d.L.), Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Bruna G', 'Initials': 'BG', 'LastName': 'Dutra', 'Affiliation': 'Department of Radiology and Nuclear Medicine (B.G.D., M.L.T., H.C.B.R.A., M.K., H.A.M., C.B.L.M.M.), location AMC, Amsterdam UMC, Academic Medical Center, the Netherlands.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Samuels', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (N.B., K.C.J.C., N.S., A.v.d.L.), Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Manon L', 'Initials': 'ML', 'LastName': 'Tolhuisen', 'Affiliation': 'Department of Radiology and Nuclear Medicine (B.G.D., M.L.T., H.C.B.R.A., M.K., H.A.M., C.B.L.M.M.), location AMC, Amsterdam UMC, Academic Medical Center, the Netherlands.'}, {'ForeName': 'Heitor C B R', 'Initials': 'HCBR', 'LastName': 'Alves', 'Affiliation': 'Department of Radiology and Nuclear Medicine (B.G.D., M.L.T., H.C.B.R.A., M.K., H.A.M., C.B.L.M.M.), location AMC, Amsterdam UMC, Academic Medical Center, the Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine (B.G.D., M.L.T., H.C.B.R.A., M.K., H.A.M., C.B.L.M.M.), location AMC, Amsterdam UMC, Academic Medical Center, the Netherlands.'}, {'ForeName': 'Geert J', 'Initials': 'GJ', 'LastName': 'Lycklama À Nijeholt', 'Affiliation': 'Department of Radiology, Haaglanden Medical Center, The Hague, the Netherlands (G.J.L.à.N.).'}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Marquering', 'Affiliation': 'Department of Radiology and Nuclear Medicine (B.G.D., M.L.T., H.C.B.R.A., M.K., H.A.M., C.B.L.M.M.), location AMC, Amsterdam UMC, Academic Medical Center, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine (B.G.D., M.L.T., H.C.B.R.A., M.K., H.A.M., C.B.L.M.M.), location AMC, Amsterdam UMC, Academic Medical Center, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health (N.B., N.S., H.F.L.), Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': ''}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine (N.B., K.C.J.C., N.S., A.v.d.L.), Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027749']
2584,32935997,Ethics of Pharma Clinical Trials in the Era of Precision Oncology.,"Pharmaceutical industry clinical trials are ethically problematic: human research subjects are being used as a means to the end of demonstrating statistically significant efficacy of novel anticancer agents to achieve regulatory registration and marketing approval. Randomized controlled trial design is inequitable since control arm patients are denied access to the postulated best treatment. Most pharma studies do not provide clinically meaningful benefit of increased overall survival and enhanced quality of life (QOL) to cohorts and are not reliably generalizable to real-world patients. Precision oncology now enables prospective identification of patients expressing a specific cancer biomarker to determine their particular eligibility for evaluation of efficiency of molecular-targeted treatments. A patient-centered approach, collecting prospective real-world data in large populations, could provide real-world evidence of cost-effective, sustained clinical benefits of survival and QOL, while preserving the ethical beneficent compact between patient and doctor.",2020,Most pharma studies do not provide clinically meaningful benefit of increased overall survival and enhanced quality of life (QOL) to cohorts and are not reliably generalizable to real-world patients.,['patients expressing a specific cancer biomarker'],[],['overall survival and enhanced quality of life (QOL'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.115772,Most pharma studies do not provide clinically meaningful benefit of increased overall survival and enhanced quality of life (QOL) to cohorts and are not reliably generalizable to real-world patients.,"[{'ForeName': 'J Harvey', 'Initials': 'JH', 'LastName': 'Turner', 'Affiliation': 'Department of Nuclear Medicine, Fiona Stanley Fremantle Hospitals Group, The University of Western Australia, Murdoch, Australia.'}]",Cancer biotherapy & radiopharmaceuticals,['10.1089/cbr.2020.4129']
2585,32936010,Letrozole combined with oral contraceptives versus oral contraceptives alone in the treatment of endometriosis-related pain symptoms: a pilot study.,"BACKGROUND


To compare the efficacy and the tolerability of letrozole combined with oral contraceptives versus oral contraceptives alone in treating endometriosis-related pain.
METHODS


A total of 820 women with endometriosis presented with endometriosis-related pain were enrolled with this study. Patients were randomly treated either with letrozole (2.5 mg/day) combined with oral contraceptives ( Desogestrel and Ethinylestradiol Tablets)  or oral contraceptives ( Desogestrel and Ethinylestradiol Tablets ) alone for 6 months. Changes in pain symptoms during treatment and in 1 months after treatment, 6-month follow-up and 12-month follow-up were evaluated. Adverse effects of each treatment protocol were recorded.
RESULTS


At completion of treatment, the intensity of chronic pelvic pain continued to decrease during treatment and at 1-month after treatment it was significantly lower than at 6-month follow-up and baseline level both in LE + oral contraceptives group (Mean ± SD,1.5 ± 1.4) and in oral contraceptives alone group(Mean ± SD,2.9 ± 1.2).The intensity of chronic pelvic pain and deep dyspareunia was significantly decrease at both 1-month after treatment and 6-month follow-up.
CONCLUSIONS


This treatment for endometriosis is a promising new modality that warrants further investigation.",2020,"At completion of treatment, the intensity of chronic pelvic pain continued to decrease during treatment and at 1-month after treatment","['endometriosis-related pain symptoms', '820 women with endometriosis presented with endometriosis-related pain were enrolled with this study']","['letrozole (2.5\u2009mg/day) combined with oral contraceptives ( Desogestrel and Ethinylestradiol Tablets)  or oral contraceptives ( Desogestrel and Ethinylestradiol Tablets ', 'letrozole combined with oral contraceptives versus oral contraceptives alone', 'Letrozole combined with oral contraceptives versus oral contraceptives alone']","['chronic pelvic pain and deep dyspareunia', 'pain symptoms', 'intensity of chronic pelvic pain', 'Adverse effects']","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1112096', 'cui_str': 'desogestrel and ethinylestradiol'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0423747', 'cui_str': 'Deep pain on intercourse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",820.0,0.0440646,"At completion of treatment, the intensity of chronic pelvic pain continued to decrease during treatment and at 1-month after treatment","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Women's Hospital, School of Medcine, Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Luan', 'Affiliation': ""Women's Hospital, School of Medcine, Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Hainan General Hospital, Haikou, China.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1807502']
2586,32936046,Vitamin D and Fatigue in Palliative Cancer: A Cross-Sectional Study of Sex Difference in Baseline Data from the Palliative D Cohort.,"Background:  Fatigue is one of the most distressing symptoms in patients with advanced cancer. Previous studies have shown an association between low vitamin D levels and fatigue.  Objectives:  The aim of this study was to investigate the association between vitamin D levels and self-assessed fatigue in cancer patients admitted to palliative care, with focus on possible sex differences.  Design:  This is a cross-sectional study.  Subjects:  Baseline data from 530 screened patients, 265 women and 265 men, from the randomized placebo-controlled trial ""Palliative-D"" were analyzed.  Measurements:  Vitamin D status was measured as 25-hydroxyvitamin D (25-OHD) and fatigue was assessed with EORTC-QLQ-PAL15 and with Edmonton Symptom Assessment System (ESAS).  Results:  In men, there was a significant correlation between 25-OHD and fatigue measured with the ""Tiredness question"" (Q11) in EORTC-QLQ-PAL15 ( p  < 0.05), where higher 25-OHD levels were associated with less fatigue. No correlation between 25-OHD and fatigue was seen for women. Fatigue measured with ESAS did not show any significant association with 25-OHD levels neither in men nor in women.  Conclusion:  Low vitamin D levels were associated with more fatigue in men but not in women. The study underscores the importance of subgroup analysis of men and women when evaluating the effect of vitamin D in clinical trials since the effect may differ between the sexes. The ongoing ""Palliative-D study"" will reveal whether vitamin D supplementation may counteract fatigue in both men and women. ClinicalTrial.gov: NCT03038516.",2020,Fatigue measured with ESAS did not show any significant association with 25-OHD levels neither in men nor in women.  ,"['patients with advanced cancer', '530 screened patients, 265 women and 265 men', 'Palliative Cancer', 'men and women', 'cancer patients admitted to palliative care']","['vitamin D supplementation', 'placebo', 'Vitamin D and Fatigue', 'vitamin D']","['vitamin D levels and self-assessed fatigue', 'Tiredness question"" (Q11) in EORTC-QLQ-PAL15', '25-OHD and fatigue', 'Vitamin D status', 'higher 25-OHD levels', '25-OHD levels', 'Fatigue', '25-hydroxyvitamin D (25-OHD) and fatigue was assessed with EORTC-QLQ-PAL15 and with Edmonton Symptom Assessment System (ESAS', 'Low vitamin D levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1859049', 'cui_str': 'Haddad syndrome'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C3472649', 'cui_str': 'Edmonton symptom assessment system'}, {'cui': 'C4285871', 'cui_str': 'Vitamin D low'}]",530.0,0.321145,Fatigue measured with ESAS did not show any significant association with 25-OHD levels neither in men nor in women.  ,"[{'ForeName': 'Caritha', 'Initials': 'C', 'LastName': 'Klasson', 'Affiliation': 'Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Helde-Frankling', 'Affiliation': 'Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Sandberg', 'Affiliation': 'Palliative Home Care and Hospice Ward, Stockholms Sjukhem, Stockholm, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Nordström', 'Affiliation': 'Palliative Home Care and Hospice Ward, Stockholms Sjukhem, Stockholm, Sweden.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Lundh-Hagelin', 'Affiliation': 'Department of Health Care Sciences, Ersta-Sköndal-Bräcke University College, Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Björkhem-Bergman', 'Affiliation': 'Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Huddinge, Sweden.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0283']
2587,32936053,Emotional Empathy in the Social Regulation of Distress: A Dyadic Approach.,"Although research suggests distressed individuals benefit from others' empathy, it is unclear how an individual's level of empathy influences dyadic responses during emotional situations. In the current study, female participants ( N  = 140; 70 dyads) were paired with a stranger. One member of each dyad (the experiencer) was randomly assigned to undergo a stressful task and disclose negative personal experiences to their partner (the listener). Experiencers paired with listeners higher in dispositional emotional empathy had less negative affect during emotional disclosure and lower sympathetic nervous system reactivity during the stressful task and disclosure. Listeners higher in emotional empathy reported more negative affect in response to their partner's distress. Furthermore, for listeners higher in emotional empathy, those who more accurately rated their partner's emotions were more physiologically influenced by their partners. Findings shed light on interpersonal functions of empathy and suggest a stranger's level of emotional empathy regulates distressed partner's emotions and physiology.",2020,Experiencers paired with listeners higher in dispositional emotional empathy had less negative affect during emotional disclosure and lower sympathetic nervous system reactivity during the stressful task and disclosure.,['female participants ( N  = 140; 70 dyads'],['stressful task and disclose negative personal experiences to their partner (the listener'],"['dispositional emotional empathy', 'emotional disclosure and lower sympathetic nervous system reactivity', 'Emotional Empathy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0227307,Experiencers paired with listeners higher in dispositional emotional empathy had less negative affect during emotional disclosure and lower sympathetic nervous system reactivity during the stressful task and disclosure.,"[{'ForeName': 'Casey L', 'Initials': 'CL', 'LastName': 'Brown', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'Tessa V', 'Initials': 'TV', 'LastName': 'West', 'Affiliation': 'New York University, New York City, USA.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Sanchez', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'Wendy Berry', 'Initials': 'WB', 'LastName': 'Mendes', 'Affiliation': 'University of California, San Francisco, USA.'}]",Personality & social psychology bulletin,['10.1177/0146167220953987']
2588,32936055,Videoconferencing Interventions for Children with Reading and Spelling Difficulties: A Pilot Study.,"Background:   Many children in rural and remote areas do not have access to professionals providing literacy interventions. However, delivery of services through videoconferencing would increase access and choice for end users.   Introduction:   This pilot study investigated the efficacy of videoconferencing literacy interventions. As videoconferencing platforms become easier and cheaper to use, this form of telehealth delivery is increasing in popularity. However, there is currently no strong evidence base to support this practice.   Materials and Methods:   We studied 18 children, aged 7-12 years, with poor reading and/or spelling, and whose literacy interventions were videoconferenced into their homes and/or schools. Children were tested on three reading measures: (1) reading words, (2) reading nonwords, and (3) letter-sound knowledge, twice before their interventions commenced and once after their intervention concluded.   Results:   Children's raw and standardized scores on 2 of 3 outcome measures increased significantly more during the intervention than in the no-intervention period before their training commenced.   Discussion and Conclusions:   This study demonstrates that videoconferencing is a promising delivery mode for literacy interventions, and the results justify running a larger, randomized controlled trial.",2020,Children's raw and standardized scores on 2 of 3 outcome measures increased significantly more during the intervention than in the no-intervention period before their training commenced.   ,"['18 children, aged 7-12 years, with poor reading and/or spelling, and whose literacy interventions were videoconferenced into their homes and/or schools', 'Children with Reading and Spelling Difficulties']","['videoconferencing', 'Videoconferencing Interventions', 'videoconferencing literacy interventions']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]",[],18.0,0.0539802,Children's raw and standardized scores on 2 of 3 outcome measures increased significantly more during the intervention than in the no-intervention period before their training commenced.   ,"[{'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Kohnen', 'Affiliation': 'Department of Cognitive Science and Macquarie University Centre for Reading, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Banales', 'Affiliation': 'Department of Cognitive Science and Macquarie University Centre for Reading, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'McArthur', 'Affiliation': 'Department of Cognitive Science and Macquarie University Centre for Reading, Macquarie University, Sydney, New South Wales, Australia.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0061']
2589,32930550,Effect of a patient activation intervention on hypertension medication optimization: results from a randomized clinical trial.,"OBJECTIVES


To examine the effect of a patient activation intervention with financial incentives to promote switching to a thiazide in patients with controlled hypertension using calcium channel blockers (CCBs).
STUDY DESIGN


The Veterans Affairs Project to Implement Diuretics, a randomized clinical trial, was conducted at 13 Veterans Affairs primary care clinics.
METHODS


Patients (n = 236) with hypertension previously controlled using CCBs were randomized to a control group (n = 90) or 1 of 3 intervention groups designed to activate patients to talk with their primary care providers about switching to thiazides: Group A (n = 53) received an activation letter, group B (n = 42) received a letter plus a financial incentive to discuss switching from a CCB to a thiazide, and group C (n = 51) received a letter, a financial incentive, and a telephone call encouraging patients to speak with their primary care providers. The primary outcome was thiazide prescribing at the index visit.
RESULTS


At the index visit, the rate of switching to a thiazide was 1.1% in the control group and 9.4% (group A), 26.2% (group B), and 31.4% (group C) for the intervention groups (P < .0001). In adjusted analysis, patients randomized to group C were significantly more likely to switch from a CCB to thiazide at the index visit (odds ratio, 4.14; 95% CI, 1.45-11.84; P < .01).
CONCLUSIONS


This low-cost, low-intensity patient activation intervention resulted in increased rates of switching to a thiazide in those whose hypertension was controlled using another medication, suggesting that such interventions may be used to overcome medication optimization challenges, including clinical inertia.",2020,"At the index visit, the rate of switching to a thiazide was 1.1% in the control group and 9.4% (group A), 26.2% (group B), and 31.4% (group C) for the intervention groups (P < .0001).","['Patients (n\u2009=\u2009236) with hypertension previously controlled using CCBs', 'patients with controlled hypertension using calcium channel blockers (CCBs', '13 Veterans Affairs primary care clinics']","['control group (n\u2009=\u200990) or 1 of 3 intervention groups designed to activate patients to talk with their primary care providers about switching to thiazides: Group A (n\u2009=\u200953) received an activation letter', 'letter plus a financial incentive to discuss switching from a CCB to a thiazide, and group C (n\u2009=\u200951) received a letter, a financial incentive, and a telephone call encouraging patients to speak with their primary care providers', 'patient activation intervention', 'thiazide']","['hypertension medication optimization', 'thiazide prescribing at the index visit', 'rate of switching to a thiazide']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",236.0,0.0446526,"At the index visit, the rate of switching to a thiazide was 1.1% in the control group and 9.4% (group A), 26.2% (group B), and 31.4% (group C) for the intervention groups (P < .0001).","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'Florida State University College of Medicine, 1115 W Call St, Tallahassee, FL 32306. Email: matthew.howren@med.fsu.edu.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Steinman', 'Affiliation': ''}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kaboli', 'Affiliation': ''}]",The American journal of managed care,['10.37765/ajmc.2020.88488']
2590,32930610,Co-Occurring Psychopathology Moderates Social Skills Improvement in a Randomized Controlled Trial of a Collaborative School-Home Intervention for Children with ADHD.,"OBJECTIVE


Children with ADHD often exhibit marked impairment in their social skills, but evidence-based psychosocial interventions for ADHD have shown limited efficacy in remediating these deficits. Co-occurring psychopathology exacerbates social deficits in children with ADHD and is a plausible moderator of treatment response. To identify factors contributing to variable social skills treatment response, we examined co-occurring externalizing, depression, and anxiety symptoms as moderators of social skills outcomes in a randomized controlled trial of the Collaborative Life Skills (CLS) program, an evidence-based collaborative school-home ADHD intervention.
METHOD


Participants were 159 children with ADHD ( M  age = 8.35 years, 28.3% female) at 27 schools in an urban public school district. Twenty-three schools were randomly assigned to CLS or usual services, with an additional four schools assigned to Spanish-adapted CLS or usual services. Multi-informant measures of co-occurring psychopathology and social skills were collected at baseline and post-treatment.
RESULTS


Parent-rated externalizing and depression symptoms moderated treatment effects on social skills, whereby higher symptomatology in each domain was unrelated to social skills improvement in the CLS group but predicted worsening social skills in response to usual services. In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
CONCLUSIONS


Findings reflect novel evidence that child psychopathology domains exhibit unique moderating effects on social skills treatment response in children with ADHD. We discuss implications for optimizing evidence-based interventions to target social impairment in this population.",2020,"In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
","['children with ADHD', 'Children with ADHD', 'Twenty-three schools', 'Participants were 159 children with ADHD ( M  age\xa0=\xa08.35\xa0years, 28.3% female) at 27 schools in an urban public school district']","['Collaborative Life Skills (CLS) program, an evidence-based collaborative school-home ADHD intervention', 'CLS or usual services, with an additional four schools assigned to Spanish-adapted CLS or usual services', 'Collaborative School-Home Intervention', 'Co-Occurring Psychopathology Moderates Social Skills']","['social skills', 'worsening social skills', 'Multi-informant measures of co-occurring psychopathology and social skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0915905', 'cui_str': 'IS 159'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",159.0,0.0397701,"In contrast, teacher-rated anxiety moderated treatment effects on social skills, whereby higher anxiety predicted greater social skills improvement in response to CLS but was unrelated to social skills outcomes following usual services.
","[{'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Jocelyn I', 'Initials': 'JI', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Pfiffner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, San Francisco.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1815206']
2591,32930719,Using Prior Culture Results to Improve Initial Empiric Antibiotic Prescribing: An Evaluation of a Simple Clinical Heuristic.,"BACKGROUND


A patient's prior cultures can inform the subsequent risk of infection from resistant organisms, yet prescribers often fail to incorporate these results into their empiric antibiotic selection. Given that timely initiation of adequate antibiotics has been associated with improved outcomes, there is urgent need to address this gap.
METHODS


In order to better incorporate prior culture results in selection of empiric antibiotics, we performed a pragmatic prospective hospital-wide intervention: (1) Empiric antibiotic prescriptions were assessed for clinically significant discordance with most recent methicillin-resistant staphylococcus aureus (MRSA) surveillance swab, previous cultures for extended-spectrum beta-lactamases (ESBLs), and most recent culture for a Gram-negative (GN) organism; (2) If discordant, an antimicrobial stewardship pharmacist provided recommendations for alternative therapy. The impact was analyzed using a quasi-experimental design comparing two 9-month periods (pre and post-intervention) at a large academic tertiary care institution.
RESULTS


Clinically significant discordance was identified 99 times in the pre-intervention period and 86 times in the intervention period. The proportion of patients that received concordant therapy increased from 73% (72/99) in the control group to 88% (76/86) in the intervention group (p=0.01). The median time to concordant therapy was shorter in the intervention group (25 vs 55 hrs; p<0.001 aHR=1.95 (95%CI 1.37-2.77, p<0.001). The median duration of unnecessary vancomycin therapy was reduced by 1.1 days (95% CI 0.5 - 1.6 days, p<0.001).
CONCLUSIONS


This intervention improved prescribing, with a shorter time to concordant therapy and increased proportion of patients receiving empiric therapy concordant with prior culture results. Use of unnecessary vancomycin was also reduced.",2020,"The median time to concordant therapy was shorter in the intervention group (25 vs 55 hrs; p<0.001 aHR=1.95 (95%CI 1.37-2.77, p<0.001).",['Prescribing'],['unnecessary vancomycin'],"['Initial Empiric Antibiotic', 'median time to concordant therapy', 'median duration of unnecessary vancomycin therapy']","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]",,0.065289,"The median time to concordant therapy was shorter in the intervention group (25 vs 55 hrs; p<0.001 aHR=1.95 (95%CI 1.37-2.77, p<0.001).","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Elligsen', 'Affiliation': 'Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care and Population Health, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Jerome A', 'Initials': 'JA', 'LastName': 'Leis', 'Affiliation': 'Division of Infectious Diseases, University of Toronto, Canada.'}, {'ForeName': 'Sandra A N', 'Initials': 'SAN', 'LastName': 'Walker', 'Affiliation': 'Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Derek R', 'Initials': 'DR', 'LastName': 'MacFadden', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Division of Infectious Diseases, University of Toronto, Canada.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1397']
2592,32930784,"Treatment of partial thickness burns: a prospective, randomised controlled trial comparing Biobrane™, Acticoat™, Mepilex® Ag and Aquacel® Ag.","INTRODUCTION


This prospective, randomised controlled trial study compared the effects of four dressings for adult partial thickness burns, focusing on re-epithelialisation time and cost-effectiveness.
METHODS


Adults with partial thickness burns meeting inclusion criteria were randomised to either Biobrane™, Acticoat™, Mepilex® Ag or Aquacel® Ag. Primary endpoint for analysis was >95% re-epithelialisation. Incremental cost effectiveness ratios were calculated based on dressing costs. Dominance probabilities between treatment arms were calculated from bootstrap resampling trial data.
RESULTS


131 partial thickness burn wounds in 119 patients were randomised. Adjusting for gender, age, smoking status, burn mechanism, TBSA, and first aid adequacy, Mepilex® Ag had a reduced time to re-epithelialisation compared to Biobrane™ (IRR 1.26; 95% CI: 1.07 - 1.48, P < 0.01). Economic analysis showed that there was a 99%, 71% and 53% probability that Mepilex® Ag dominated (cheaper and more effective) Biobrane™, Acticoat™ and Aquacel® Ag, respectively.
CONCLUSIONS


Mepilex® Ag achieved faster re-epithelialisation and better cost effectiveness. Patient satisfaction and comfort seems better with Biobrane™ although not reflected within the end outcome of the healed wound. It is the patients' (after extensive education) and clinicians' choice, level of experience and availability of products in praxis that will guide the decision as to which product is used individually on which patient.",2020,"Economic analysis showed that there was a 99%, 71% and 53% probability that Mepilex® Ag dominated (cheaper and more effective)","['partial thickness burns', '131 partial thickness burn wounds in 119 patients', 'adult partial thickness burns', 'Adults with partial thickness burns meeting inclusion criteria']","['Biobrane™, Acticoat™, Mepilex® Ag or Aquacel® Ag']","['re-epithelialisation time and cost-effectiveness', 'Incremental cost effectiveness ratios', 'Dominance probabilities', 'faster re-epithelialisation and better cost effectiveness', 'effective']","[{'cui': 'C0332687', 'cui_str': 'Second degree burn injury'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0053620', 'cui_str': 'Biobrane'}, {'cui': 'C0763683', 'cui_str': 'Acticoat'}, {'cui': 'C0967370', 'cui_str': 'Aquacel'}]","[{'cui': 'C0334221', 'cui_str': 'Re-epithelialization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",119.0,0.124096,"Economic analysis showed that there was a 99%, 71% and 53% probability that Mepilex® Ag dominated (cheaper and more effective)","[{'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Aggarwala', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Harish', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Brady', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Sepher', 'Initials': 'S', 'LastName': 'Lajevardi', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Doherty', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': ""D'Souza"", 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Haertsch', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Peter K M', 'Initials': 'PKM', 'LastName': 'Maitz', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Issler-Fisher', 'Affiliation': 'Burns Unit, Concord Repatriation General Hospital, Hospital Rd, Concord NSW, Australia.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa158']
2593,32930794,Making community-supported agriculture accessible to low-income families: findings from the Farm Fresh Foods for Healthy Kids process evaluation.,"A randomized trial of Farm Fresh Foods for Healthy Kids (F3HK) was initiated across 4 states and 12 farms to test whether cost-offset community-supported agriculture (CO-CSA) could improve diet quality among children in low-income families. Intervention households purchased a 50% subsidized share of local produce and were invited to nine complimentary nutrition classes. The purpose of this study was to assess F3HK reach, dose, and fidelity via a mixed methods process evaluation. Screening and enrollment records indicated reach; study records and postlesson educator surveys tracked dose delivered; CSA pickup logs, lesson sign-in sheets, postseason participant surveys, and postlesson caregiver surveys assessed dose received; and coordinator audits and educator surveys tracked fidelity. Educator interviews contextualized findings. The results of this study were as follows. Reach: enrolled caregivers (n = 305) were older (p = .005) than eligible nonenrollees (n = 243) and more likely to be female (p < .001). Dose: mean CSA season was 21 weeks (interquartile range [IQR]: 19-23). Median CSA pickup was 88% of the weeks (IQR: 40-100). All sites offered each class at least once. Most adults (77%) and children (54%) attended at least one class; few attended all. Eighty-two percent of caregivers indicated that their household consumed most or all produce. Median lesson activity ratings were 5/5 (""very useful""). Fidelity: CSA locations functioned with integrity to project standards. Educators taught 92% of activities but frequently modified lesson order. This study demonstrates the feasibility of pairing a CO-CSA intervention with nutrition education across geographically dispersed sites. Greater integration of intervention elements and clearer allowance for site-level modifications, particularly for educational elements, may improve intervention dose and, ultimately, impact.",2020,Reach: enrolled caregivers (n = 305) were older (p = .005) than eligible nonenrollees (n = 243) and more likely to be female (p < .001).,"['Intervention households purchased a 50% subsidized share of local produce and were invited to nine complimentary nutrition classes', 'Healthy Kids (F3HK', 'children in low-income families', 'Most adults (77%) and children (54%) attended at least one class; few attended all']","['Farm Fresh Foods', 'CO-CSA intervention', 'cost-offset community-supported agriculture (CO-CSA']","['diet quality', 'Median lesson activity ratings', 'Fidelity', 'Median CSA pickup']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0453829', 'cui_str': 'Fresh food'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]",305.0,0.0588827,Reach: enrolled caregivers (n = 305) were older (p = .005) than eligible nonenrollees (n = 243) and more likely to be female (p < .001).,"[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Garner', 'Affiliation': 'School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Stephanie B', 'Initials': 'SB', 'LastName': 'Jilcott Pitts', 'Affiliation': 'Brody School of Medicine, Department of Public Health, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Karla L', 'Initials': 'KL', 'LastName': 'Hanson', 'Affiliation': 'Master of Public Health Program, Department of Population Medicine and Diagnostic Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Ammerman', 'Affiliation': 'Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kolodinsky', 'Affiliation': 'Department of Community Development and Applied Economics, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Marilyn H', 'Initials': 'MH', 'LastName': 'Sitaker', 'Affiliation': 'Ecological Agriculture and Food Systems, The Evergreen State College, Olympia, WA, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': 'Department of Nutrition and Food Science, Texas A&M University, College Station, TX, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa080']
2594,32930848,Anthocyanins regulate serum adipsin and visfatin in patients with prediabetes or newly diagnosed diabetes: a randomized controlled trial.,"BACKGROUND


Epidemiological studies have suggested that adipsin and visfatin are associated with the development of type 2 diabetes. This is the first study to investigate the effects of supplementation with purified anthocyanins on serum adipsin and visfatin in patients with prediabetes or newly diagnosed diabetes.
METHODS


A total of 160 participants with prediabetes or newly diagnosed diabetes (40-75 years old) were given 320 mg anthocyanins or placebo daily for 12 weeks in a randomized trial. Serum adipsin, serum visfatin, lipids and glycated hemoglobin A1c (HbA1c) were measured. The areas under the curve (AUCs) for glucose, insulin and C-peptide were determined before-and after-treatment by a standard 3-h 75 g oral glucose tolerance test (OGTT).
RESULTS


Relatively significant increases in serum adipsin (net change 0.15 µg/mL [0.03, 0.27], p = 0.018) and decreases in visfatin (-3.5 ng/mL [-6.69, -0.31], p = 0.032) were observed between the anthocyanins and placebo groups. We also observed significant improvements in HbA1c (-0.11% [-0.22, -0.11], p = 0.033), apolipoprotein A-1 (apo A-1) (0.12 g/L [0.03, 0.21], p = 0.012) and apolipoprotein B (apo B) (-0.07 g/L [-0.14, -0.01], p = 0.033) in response to the anthocyanins intervention.
CONCLUSION


Purified anthocyanins supplementation for 12 weeks increased serum adipsin and decreased serum visfatin in patients with prediabetes or newly diagnosed diabetes. Trial registration ClinicalTrials.gov, identifier: NCT02689765.",2020,Purified anthocyanins supplementation for 12 weeks increased serum adipsin and decreased serum visfatin in patients with prediabetes or newly diagnosed diabetes.,"['160 participants with prediabetes or newly diagnosed diabetes (40-75\xa0years old', 'patients with prediabetes or newly diagnosed diabetes']","['purified anthocyanins', 'anthocyanins or placebo', 'Purified anthocyanins supplementation', 'Anthocyanins']","['serum adipsin', 'serum adipsin and visfatin', 'serum adipsin and decreased serum visfatin', 'Serum adipsin, serum visfatin, lipids and glycated hemoglobin A1c (HbA1c', 'areas under the curve (AUCs) for glucose, insulin and C-peptide', 'apolipoprotein B (apo B', 'visfatin', 'apolipoprotein A-1', 'HbA1c']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1320655', 'cui_str': 'Newly diagnosed diabetes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033457', 'cui_str': 'Complement factor D'}, {'cui': 'C0068707', 'cui_str': 'Nicotinamide phosphoribosyltransferase'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]",160.0,0.0933329,Purified anthocyanins supplementation for 12 weeks increased serum adipsin and decreased serum visfatin in patients with prediabetes or newly diagnosed diabetes.,"[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th ZhongShan Road II, GuangZhou, 510080, PR China. yanglp6@mail2.sysu.edu.cn.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th ZhongShan Road II, GuangZhou, 510080, PR China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th ZhongShan Road II, GuangZhou, 510080, PR China.'}, {'ForeName': 'Zhaomin', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th ZhongShan Road II, GuangZhou, 510080, PR China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th ZhongShan Road II, GuangZhou, 510080, PR China.'}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Center for Chronic Disease Control, Nanshan, ShenZhen, PR China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Center for Chronic Disease Control, Nanshan, ShenZhen, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Center for Chronic Disease Control, Nanshan, ShenZhen, PR China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'GuangDong Province, BaiYun Hospital, YueXiu District, GuangZhou, PR China.'}]",European journal of nutrition,['10.1007/s00394-020-02379-x']
2595,32930855,[Surgical techniques in the treatment of basal cell carcinoma-a prospective investigation].,"BACKGROUND


Basal cell carcinomas are the most frequent epithelial skin tumors and a frequent indication for dermatological interventions. Despite the establishment of drug treatment options, surgery is still the treatment of choice. Various options are available ranging from curettage to complex dermatosurgical procedures. In addition to the main aspect of low local recurrence rates, esthetic factors and the number of procedures are also important for the choice of treatment.
METHODS


In this study 347 patients with 398 basal cell carcinomas (nodular type, diameter up to 10 mm) were prospectively examined. The patients were randomized into two treatment arms: in one group the tumor was treated by ring curettage and in the other group the tumor was excised. Patients who underwent 3D histologically controlled surgery due to basal cell carcinoma during the same investigation period served as controls.
RESULTS


The highest local recurrence rate was observed after curettage (14.0%), whereas the group with 3D histology had the lowest recurrence rate (0.9%, p < 0.001). In the 3D group, more re-excisions were required to achieve complete tumor clearance compared to the group who underwent excisions with serial section histology. Patients rated the esthetic outcome best after curettage. The median follow-up was 3.9 years.
CONCLUSION


The choice of surgical treatment for small nodular basal cell carcinomas depends on individual circumstances. Excisions controlled by 3D histology with wound closure after complete tumor clearance showed the lowest recurrence rate in our study; however, curettage is also a possible surgical treatment option with minimal effort and an acceptable recurrence rate, which can lead to good esthetic results.",2020,"The highest local recurrence rate was observed after curettage (14.0%), whereas the group with 3D histology had the lowest recurrence rate (0.9%, p < 0.001).","['347 patients with 398 basal cell carcinomas (nodular type, diameter up to 10\xa0mm', 'Patients who underwent 3D histologically controlled surgery due to basal cell carcinoma during the same investigation period served as controls', 'small nodular basal cell carcinomas']",[],"['lowest recurrence rate', 'highest local recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205276', 'cui_str': 'Local'}]",347.0,0.0156459,"The highest local recurrence rate was observed after curettage (14.0%), whereas the group with 3D histology had the lowest recurrence rate (0.9%, p < 0.001).","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Kofler', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Hans-Martin', 'Initials': 'HM', 'LastName': 'Häfner', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland. hans-martin.haefner@med.uni-tuebingen.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eichner', 'Affiliation': 'Institut für Klinische Epidemiologie und angewandte Biometrie, Eberhard Karls Universität Tübingen, Silcherstr.\xa05, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kofler', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Saskia Maria', 'Initials': 'SM', 'LastName': 'Schnabl', 'Affiliation': ''}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Breuninger', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}]","Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete",['10.1007/s00105-020-04685-1']
2596,32924560,Complementary Therapies for Patients with Cancer: Reflexology and Relaxation in Integrative Palliative Care. A Randomized Controlled Comparative Study.,"Objectives:  Comparison of the effects of reflexology and relaxation on pain, anxiety, and depression, and quality of life (QoL) of patients with cancer.  Design:  A stratified random sample was selected, using an experimental design.  Location:  An outpatient Palliative Care Unit in Attica, Greece.  Subjects:  88 patients suffering with cancer.  Interventions:  The sample was randomly divided into two equal groups, a reflexology and a relaxation group. The number of interventions for both groups was six 30-min weekly sessions.  Outcome measures:  The Greek Brief Pain Inventory (G-BPI) was used to measure pain, the Greek Hospital Anxiety and Depression Scale for screening anxiety and depression, and finally the Short Form Health Survey was used to measure QoL. Measurements of the above tools were taken three times in both groups as follows: preintervention, at fourth and at sixth week of intervention.  Results:  Anxiety and depression for both groups exhibited a statistically significant decrease during the observation period (p < 0.001, η 2  > 0.25) but at the sixth week, there was a more significant decrease in the reflexology group compared with the relaxation group (p = 0.062, η 2  = 0.044 vs. p = 0.005, η 2  = 0.096 for anxiety), (p = 0.006, η 2  = 0.094 vs. p = 0.001, η 2  = 0.138 for depression). QoL physical and mental component measurements were significantly greater for the reflexology group (p < 0.001, η 2  = 0.168 and p = 0.017, η 2  = 0.071, respectively). The baseline-to-sixth week G-BPI measurements were markedly decreased for the reflexology group (p = 0.207, η 2  = 0.020).  Conclusions:  Both interventions, relaxation and reflexology, seemed to be effective in decreasing anxiety and depression in patients with cancer. However, reflexology was found to be more effective in improving QoL (physical component) and to have a greater effect on pain management than relaxation.",2020,"QoL physical and mental component measurements were significantly greater for the reflexology group (p < 0.001, η 2  = ","['88 patients suffering with cancer', 'Patients with Cancer', 'patients with cancer']","['reflexology and relaxation', 'reflexology and a relaxation group']","['QoL physical and mental component measurements', 'Greek Brief Pain Inventory (G-BPI) was used to measure pain, the Greek Hospital Anxiety and Depression Scale for screening anxiety and depression, and finally the Short Form Health Survey', 'Anxiety and depression', 'pain, anxiety, and depression, and quality of life (QoL', 'baseline-to-sixth week G-BPI measurements', 'anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0439230', 'cui_str': 'week'}]",88.0,0.0144668,"QoL physical and mental component measurements were significantly greater for the reflexology group (p < 0.001, η 2  = ","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Mantoudi', 'Affiliation': 'Department of Nursing, University of West Attica, Athens, Greece.'}, {'ForeName': 'Efi', 'Initials': 'E', 'LastName': 'Parpa', 'Affiliation': 'Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Tsilika', 'Affiliation': 'Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Chrysanthi', 'Initials': 'C', 'LastName': 'Batistaki', 'Affiliation': 'Attikon University Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nikoloudi', 'Affiliation': 'Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Kouloulias', 'Affiliation': 'Radiotherapy Unit, Department of Radiology, Attikon University Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sotiria', 'Initials': 'S', 'LastName': 'Kostopoulou', 'Affiliation': 'Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Galanos', 'Affiliation': 'Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Kyriaki', 'Initials': 'K', 'LastName': 'Mystakidou', 'Affiliation': 'Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, Greece.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0402']
2597,32924566,"Effects of Sequential Prepaid Incentives on Response Rates, Data Quality, Sample Representativeness, and Costs in a Mail Survey of Physicians.","While collecting high quality data from physicians is critical, response rates for physician surveys are frequently low. A proven method for increasing response in mail surveys is to provide a small, prepaid monetary incentive in the initial mailing. More recently, researchers have begun experimenting with adding a second cash incentive in a follow-up contact in order to increase participation among more reluctant respondents. To assess the effects of sequential incentives on response rates, data quality, sample representativeness, and costs, physicians (N = 1,500) were randomly assigned to treatments that crossed the amount of a first ($5 or $10) and second ($0, $5, or $10) incentive to form the following groups: Group $5/$5; Group $5/$10; Group $10/$0; Group $10/$5; and Group $10/$10. Overall, second incentives were associated with higher response rates and lower costs per completed survey, and while they had no effect on item nonresponse, they increased sample representativeness.",2020,"Overall, second incentives were associated with higher response rates and lower costs per completed survey, and while they had no effect on item nonresponse, they increased sample representativeness.","['physicians (N = 1,500']",['Sequential Prepaid Incentives'],"['response rates, data quality, sample representativeness, and costs', 'Response Rates, Data Quality, Sample Representativeness, and Costs in a Mail Survey of Physicians']","[{'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0242483', 'cui_str': 'Data Quality'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",1500.0,0.025814,"Overall, second incentives were associated with higher response rates and lower costs per completed survey, and while they had no effect on item nonresponse, they increased sample representativeness.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dykema', 'Affiliation': 'University of Wisconsin Survey Center, 5228University of Wisconsin-Madison, WI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stevenson', 'Affiliation': 'University of Wisconsin Survey Center, 5228University of Wisconsin-Madison, WI, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Assad', 'Affiliation': 'University of Wisconsin Survey Center, 5228University of Wisconsin-Madison, WI, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Kniss', 'Affiliation': 'University of Wisconsin Survey Center, 5228University of Wisconsin-Madison, WI, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Taylor', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences,5783Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.'}]",Evaluation & the health professions,['10.1177/0163278720958186']
2598,32924568,Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting - The GoBolus Study.,"BACKGROUND


The GoBolus study (NCT03450863) investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems.
METHODS


This 24-week, multicenter, single-arm, non-interventional study investigated adults with T1D (HbA1c, 7.5-9.5%) receiving multiple daily insulin injections (MDI) and using iscCGM within local healthcare settings for ≥6 months prior to switching to faster aspart at study start (Week 0; baseline). Primary endpoint was HbA1c change from baseline to Week 24. Exploratory endpoint was change in iscCGM metrics from baseline to Week 24.
RESULTS


Overall, 243 patients were included (55.6% male), with mean: age/diabetes duration, 49.9/18.8 years; HbA1c, 8.1%. By Week 24, HbA1c had decreased by 0.19% (-2.1 mmol/mol, p<0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data (n=92): 'time in range' (TIR, 3.9-10.0 mmol/L) increased from 46.9% to 50.1% (p=0.01), corresponding to an increase of 46.1 minutes per day; time in hyperglycemia decreased from 49.1% to 46.1% (>10.0 mmol/L, p=0.026) and 20.4% to 17.9% (>13.9 mmol/L, p=0.013), corresponding to 43.5 (p=0.024) and 35.6 (p=0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (<3.9 and <3.0 mmol/L). Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.035) and 11.9 to 11.0 mmol/L (p=0.002), respectively.
CONCLUSION


Real-world switching to faster aspart in adults with T1D on MDI improved HbA1c, increased TIR, and decreased time in hyperglycemia without affecting time in hypoglycemia.",2020,"Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.035) and 11.9 to 11.0 mmol/L (p=0.002), respectively.
","['Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting - The GoBolus Study', 'adults with T1D (HbA1c, 7.5-9.5%) receiving multiple daily insulin injections (MDI) and using iscCGM within local healthcare settings for ≥6 months prior to switching to faster aspart at study start (Week 0; baseline', '243 patients were included (55.6% male), with mean: age/diabetes duration, 49.9/18.8 years; HbA1c, 8.1', 'patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems']",['Fast-Acting Insulin Aspart'],"['iscCGM metrics', 'Mean interstitial and postprandial glucose', 'time in hyperglycemia', 'insulin doses or basal/bolus insulin ratios', 'MDI improved HbA1c, increased TIR, and decreased time in hyperglycemia', 'time in hypoglycemia', 'HbA1c change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",243.0,0.0333406,"Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.035) and 11.9 to 11.0 mmol/L (p=0.002), respectively.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Kinderkrankenhaus auf der Bult, Diabetes Centre for Children and Adolescents, Janusz-Korczak Allee 12, Hannover, Germany, 30173; danne@hka.de.'}, {'ForeName': 'Matthias Axel', 'Initials': 'MA', 'LastName': 'Schweitzer', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany; qmsw@novonordisk.com.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Keuthage', 'Affiliation': 'Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Muenster, Germany; info@diabetes-praxis-muenster.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kipper', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany; stkp@novonordisk.com.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Kretzschmar', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany; yasm@novonordisk.com.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Medizinisches Versorgungszentrum im Altstadt-Carree Fulda GmbH, Fulda, Germany; simon.fulda@t-online.de.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Wiedenmann', 'Affiliation': 'Novo Nordisk Pharma GmbH, Mainz, Germany; tnwd@novonordisk.com.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Ziegler', 'Affiliation': 'Diabetes Clinic for Children and Adolescents, Mondstr.148, Muenster, Germany, 48155; rz@ziegler-muenster.de.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0360']
2599,32924586,Transcranial Direct Current Stimulation Combined With Cognitive Training Induces Response Inhibition Facilitation Through Distinct Neural Responses According to the Stimulation Site: A Follow-up Event-Related Potentials Study.,"OBJECTIVE


We investigated whether the mid-term impact (1 week posttraining) of a ""combined cognitive rehabilitation (CRP)/transcranial direct current stimulation (tDCS) program"" on the performance of a Go/No-go task was enhanced compared with isolated CRP and whether it varied according to the stimulation site (right inferior frontal gyrus [rIFG] vs right dorsolateral prefrontal cortex [rDLPFC]).
METHODS


A total of 150 healthy participants were assigned to (1) an Inhibition Training (IT) group, (2) a group receiving active tDCS over the rIFG in combination with IT (IT + IF), (3) a group receiving active tDCS over the rDLPFC in combination with IT (IT + DL), (4) a group receiving IT with sham tDCS (ITsham), and (5) a No-Training (NT) group to control for test-retest effects. Each group undertook 3 sessions of a Go/No-go task concomitant with the recording of event-related potentials (T0, before training; T1, at the end of a 4-day training session [20 minutes each day]; T2, 1 week after T1).
RESULTS


With the exception of the NT participants, all the groups exhibited improved performances at T2. The IT + DL group exhibited the best improvement profile, indexed by faster response times (RTs) (T0 > T1 = T2), with a reduced rate of errors at the posttraining sessions compared with both T0 and T1. This ""inhibitory learning effect"" was neurophysiologically indexed by shorter No-go N2d latencies and enhanced No-go P3d amplitudes.
CONCLUSION


CRP combined with active tDCS over the rDLPFC appears to be optimal for boosting long-term (one week) inhibitory skills as it induced specific and robust neural changes.",2020,"No-go task was enhanced compared with isolated CRP and whether it varied according to the stimulation site (right inferior frontal gyrus [rIFG] vs right dorsolateral prefrontal cortex [rDLPFC]).
",['150 healthy participants'],"['combined cognitive rehabilitation (CRP)/transcranial direct current stimulation (tDCS) program', 'Transcranial Direct Current Stimulation Combined With Cognitive Training', 'Inhibition Training (IT) group, (2) a group receiving active tDCS over the rIFG in combination with IT (IT + IF), (3) a group receiving active tDCS over the rDLPFC in combination with IT (IT + DL), (4) a group receiving IT with sham tDCS (ITsham), and (5) a No-Training (NT', 'CRP combined with active tDCS']","['rate of errors', 'faster response times (RTs']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",150.0,0.0257827,"No-go task was enhanced compared with isolated CRP and whether it varied according to the stimulation site (right inferior frontal gyrus [rIFG] vs right dorsolateral prefrontal cortex [rDLPFC]).
","[{'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Dousset', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Ingels', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Schröder', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Angioletti', 'Affiliation': 'Research Unit in Affective and Social Neuroscience, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Balconi', 'Affiliation': 'Research Unit in Affective and Social Neuroscience, Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kornreich', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Campanella', 'Affiliation': ""Laboratoire de Psychologie Médicale et d'Addictologie, ULB Neuroscience Institute (UNI), CHU Brugmann-Université Libre de Bruxelles (U.L.B.), Belgium.""}]",Clinical EEG and neuroscience,['10.1177/1550059420958967']
2600,32924589,People living with dementia and their family carers' adherence to home-based Tai Chi practice.,"OBJECTIVES


The aim of this study was to understand what influenced people living with dementia and their family carers' adherence to the home-based component of a Tai Chi exercise intervention.
METHOD


Dyads, of people living with dementia and their family carers, who participated in the intervention arm of the Tai Chi for people living with dementia trial, were invited to join weekly Tai Chi classes for 20 weeks and practice at home. Semi-structured dyadic home interviews were conducted on average after 16 weeks of classes. The views of 15 dyads with a range of home practice adherence were sought in semi-structured interviews. The interviews were analysed using an inductive thematic approach.
RESULTS


Most participants found time to practise Tai Chi at home and practised for 18 hours on average. Amongst the barriers to adherence were participants' competing commitments and a booklet not sufficiently conveying the Tai Chi movements. Hence, a video or DVD was requested by participants. Facilitators of their adherence to the home-based component of the intervention were their enjoyment of the practice and the development of a habit, which was supported by their commitment to the study and their willingness to benefit from Tai Chi.
CONCLUSION


Enjoyment and perceived benefits had a great impact on participants living with dementia and their carers' adherence to home-based Tai Chi practice. However, difficulties to perceive the Tai Chi movements through images might be hindering sustained participation. Hence, alternative aids such as videos and DVDs should be explored to facilitate adherence.",2020,"Facilitators of their adherence to the home-based component of the intervention were their enjoyment of the practice and the development of a habit, which was supported by their commitment to the study and their willingness to benefit from Tai Chi.
CONCLUSION


Enjoyment and perceived benefits had a great impact on participants living with dementia and their carers' adherence to home-based Tai Chi practice.","[""People living with dementia and their family carers' adherence to home-based Tai Chi practice"", 'Dyads, of people living with dementia and their family carers, who participated in the intervention arm of the Tai Chi for people living with dementia trial', ""people living with dementia and their family carers' adherence"", ""participants living with dementia and their carers' adherence to home-based Tai Chi practice""]",['Tai Chi exercise intervention'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],15.0,0.0446001,"Facilitators of their adherence to the home-based component of the intervention were their enjoyment of the practice and the development of a habit, which was supported by their commitment to the study and their willingness to benefit from Tai Chi.
CONCLUSION


Enjoyment and perceived benefits had a great impact on participants living with dementia and their carers' adherence to home-based Tai Chi practice.","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Barrado-Martín', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre (ADRC), 6657Bournemouth University, Fern Barrow, Poole, UK Centre for Ageing & Population Studies, Research Department of Primary Care & Population Health, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Heward', 'Affiliation': 'Ageing & Dementia Research Centre (ADRC) and Department of Rehabilitation and Sport Science, 6657Bournemouth University, Fern Barrow, Poole, UK.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Polman', 'Affiliation': 'School Exercise & Nutrition Sciences, 72524Queensland University of Technology, Australia.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Nyman', 'Affiliation': 'Department of Psychology and Ageing & Dementia Research Centre (ADRC), 6657Bournemouth University, Fern Barrow, Poole, UK Department of Medical Science, Public Health, Bournemouth University, Fern Barrow, Poole, UK.'}]","Dementia (London, England)",['10.1177/1471301220957758']
2601,32924804,Use of a dual-layer amniotic membrane in the treatment of diabetic foot ulcers: an observational study.,"BACKGROUND


Despite advances in the treatment, fewer than half of diabetic foot ulcers (DFUs) heal in 12 weeks and 85% of non-traumatic amputations follow the development of a DFU. The search for treatment options continues. Placental-derived products have shown promise in the treatment of DFUs. This study investigates Artacent (Tides Medical, US), a unique amniotic patch containing two layers of amnion and its potential to increase growth factor delivery.
METHOD


This observational analysis included patients with DFUs with documented failure to heal by >50% after the protocol-defined run-in period (either two or four weeks) of standard of care (SOC), and who had been randomised in a larger clinical trial that had been discontinued earlier for logistical reasons. Patients were randomised to either weekly or biweekly application of the dual-layer amniotic membrane (DLAM) plus SOC and were included in per-protocol effectiveness analyses. Descriptive statistics were chosen for this analysis. Primary endpoint was complete closure at 12 weeks.
RESULTS


A total of 26 patients were included in the analysis. Examination of baseline patient characteristics revealed that the ulcers were larger than in most DFU clinical trials (4.65±4.89cm 2 ). For the primary endpoint, 17/26 (65%, 95% CI: 44-83%) of the combined treatment arms achieved complete closure. The small sample size precluded a meaningful comparison of healing between weekly and biweekly DLAM applications.
CONCLUSION


The observations taken from the discontinued clinical trial suggest that the DLAM promotes healing of DFUs. The healing rates are similar to those in other placental-based tissue studies. In addition, the relatively larger size of the ulcers suggests that the DLAM may be effective in ulcers that are more resistant to standard of care. In the future, a revised clinical trial with a greater sample size is planned.",2020,"For the primary endpoint, 17/26 (65%, 95% CI: 44-83%) of the combined treatment arms achieved complete closure.","['A total of 26 patients were included in the analysis', 'patients with DFUs with documented failure to heal by >50% after the protocol-defined run-in period (either two or four weeks) of standard of care (SOC), and who had been randomised in a larger clinical trial that had been discontinued earlier for logistical reasons', 'diabetic foot ulcers']","['dual-layer amniotic membrane (DLAM) plus SOC', 'DLAM', 'dual-layer amniotic membrane']","['healing of DFUs', 'healing rates', 'complete closure', 'complete closure at 12 weeks']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439230', 'cui_str': 'week'}]",26.0,0.223296,"For the primary endpoint, 17/26 (65%, 95% CI: 44-83%) of the combined treatment arms achieved complete closure.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Sledge', 'Affiliation': 'Tides Medical, Lafayette LA, US.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maislin', 'Affiliation': 'Biomedical Statistical Consulting, Wynnewood, PA, US.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Bernarducci', 'Affiliation': 'MCRA, Washington, DC, US.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Snyder', 'Affiliation': 'Barry University, Miami Shores, FL, US.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Serena', 'Affiliation': 'SerenaGroup Research Foundation, Cambridge, MA, US.'}]",Journal of wound care,['10.12968/jowc.2020.29.Sup9.S8']
2602,32924891,The StrokeCog study: development and description of a cognition-focused psychological intervention to address cognitive impairment following stroke.,"OBJECTIVE


To describe the process of developing a cognitive rehabilitation intervention for patients with post-stroke cognitive impairment (PSCI) and to describe the intervention prior to evaluation in a pilot randomised controlled trial (RCT).  Method:  The Medical Research Council framework, 'Developing and evaluating complex interventions', was used to develop the cognitive rehabilitation intervention. We conducted a combined analysis of the existing evidence base for PSCI rehabilitation alongside qualitative exploration of the perspectives of stroke survivors, their families, and healthcare professionals providing stroke care, on the necessary components for a cognitive rehabilitation intervention for PSCI. The Template for Intervention Description and Replication checklist was used as a structural framework for the description of the intervention.  Results:  The intervention comprises a five-week intervention integrating group-based activities, supported by a clinical neuropsychologist, with home-based activities to encourage self-efficacy through the practice of adjustment and compensatory strategies learned in the group format to achieve the patients' identified goals in managing their PSCI.  Conclusion:  A cognitive rehabilitation intervention for patients with PSCI has been developed and described. We are in the process of developing a structured intervention manual to standardise the content and delivery of the intervention for further testing in a pilot RCT.",2020,"The intervention comprises a five-week intervention integrating group-based activities, supported by a clinical neuropsychologist, with home-based activities to encourage self-efficacy through the practice of adjustment and compensatory strategies learned in the group format to achieve the patients' identified goals in managing their PSCI.  ","['patients with post-stroke cognitive impairment (PSCI', 'patients with PSCI']","['cognitive rehabilitation intervention', 'cognition-focused psychological intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",[],,0.0326479,"The intervention comprises a five-week intervention integrating group-based activities, supported by a clinical neuropsychologist, with home-based activities to encourage self-efficacy through the practice of adjustment and compensatory strategies learned in the group format to achieve the patients' identified goals in managing their PSCI.  ","[{'ForeName': 'Niamh A', 'Initials': 'NA', 'LastName': 'Merriman', 'Affiliation': 'Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gillan', 'Affiliation': 'Department of Psychology, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Pender', 'Affiliation': 'Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Williams', 'Affiliation': 'Department of Geriatric and Stroke Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Horgan', 'Affiliation': 'School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Eithne', 'Initials': 'E', 'LastName': 'Sexton', 'Affiliation': 'Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Johnston', 'Affiliation': 'Aberdeen Health Psychology Group, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Bennett', 'Affiliation': 'Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Nora-Ann', 'Initials': 'NA', 'LastName': 'Donnelly', 'Affiliation': 'Social Research Division, Economic and Social Research Institute, Dublin, Ireland.'}, {'ForeName': 'Maev-Ann', 'Initials': 'MA', 'LastName': 'Wren', 'Affiliation': 'Social Research Division, Economic and Social Research Institute, Dublin, Ireland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickey', 'Affiliation': 'Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",Psychology & health,['10.1080/08870446.2020.1820009']
2603,32924893,A multiple levels of analysis examination of the performance goal model of depression vulnerability in preadolescent children.,"If performance goals (i.e., motivation to prove ability) increase children's vulnerability to depression (Dykman, 1998), why are they overlooked in the psychopathology literature? Evidence has relied on self-report or observational methods and has yet to articulate how this vulnerability unfolds across levels of analysis implicated in stress-depression linkages; for example, hypothalamic-pituitaryadrenal axis (HPA), sympathetic nervous system (SNS). Utilizing a multiple-levels-of-analysis approach (Cicchetti, 2010), this experimental study tested Dykman's goal orientation model of depression vulnerability in a community sample of preadolescents (N = 121, Mage = 10.60 years, Range = 9.08-12.00 years, 51.6% male). Self-reports of performance goals, attachment security, and subjective experience of internalizing difficulties were obtained in addition to objective behavioral (i.e., task persistence) and physiologic arousal (i.e., salivary cortisol, skin conductance level) responses to the Trier Social Stress Test (TSST) and two randomly assigned coping conditions: avoidance, distraction. Children with performance goals reported greater internalizing difficulties and exhibited more dysregulated TSST physiologic responses (i.e., HPA hyperreactivity, SNS protracted recovery), yet unexpectedly displayed greater TSST task persistence and more efficient physiologic recovery during avoidance relative to distraction. These associations were stronger and nonsignificant in the context of insecure and secure attachment, respectively. Findings illustrate a complex matrix of in-the-moment, integrative psychobiological relationships linking performance goals to depression vulnerability.",2020,"Children with performance goals reported greater internalizing difficulties and exhibited more dysregulated TSST physiologic responses (i.e., HPA hyperreactivity, SNS protracted recovery), yet unexpectedly displayed greater TSST task persistence and more efficient physiologic recovery during avoidance relative to distraction.","['preadolescent children', 'depression vulnerability in a community sample of preadolescents (N = 121, Mage = 10.60 years, Range = 9.08-12.00 years, 51.6% male']","['Trier Social Stress Test (TSST) and two randomly assigned coping conditions: avoidance, distraction']","['objective behavioral (i.e., task persistence) and physiologic arousal (i.e., salivary cortisol, skin conductance level) responses', 'TSST task persistence', 'dysregulated TSST physiologic responses']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",,0.0588605,"Children with performance goals reported greater internalizing difficulties and exhibited more dysregulated TSST physiologic responses (i.e., HPA hyperreactivity, SNS protracted recovery), yet unexpectedly displayed greater TSST task persistence and more efficient physiologic recovery during avoidance relative to distraction.","[{'ForeName': 'Jason José', 'Initials': 'JJ', 'LastName': 'Bendezú', 'Affiliation': 'The Institute of Child Development, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alaina', 'Initials': 'A', 'LastName': 'Wodzinski', 'Affiliation': 'Department of Psychology, Montclair State University, Montclair, NJ, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Loughlin-Presnal', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Mozeko', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Sierra', 'Initials': 'S', 'LastName': 'Cobler', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Martha E', 'Initials': 'ME', 'LastName': 'Wadsworth', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, University Park, PA, USA.'}]",Development and psychopathology,['10.1017/S0954579420000851']
2604,32924897,Adjunctive bright light treatment with gradual advance in unipolar major depressive disorder with evening chronotype - A randomized controlled trial.,"BACKGROUND


Unipolar non-seasonal depressed patients with concomitant evening chronotype were associated with poor clinical outcomes and higher non-remission rate. This study aims to examine the efficacy of adjunctive bright light therapy with gradual timing advance in a randomized, assessor and prescriber-blinded controlled trial.
METHOD


Participants were randomly allocated to receive 5 weeks of either bright white light therapy (BLT) or dim red light (DRL) with the same advancement protocol. Participants were followed up till 5 months after treatment. Primary outcomes included (i) remission rate and (ii) the severity of depression. The analysis was conducted using Kaplan-Meier survival analysis, Cox proportional hazard analysis and linear mixed models.
RESULTS


A total of 93 participants (46.4 ± 11.7 years old, 80% female) were randomized. The cumulative remission rate for the BLT and the DRL groups was 67.4% and 46.7%, respectively. Time to remission was shorter for the BLT group relative to the DRL group (log-rank test p = 0.024). Cox proportional hazard survival analysis showed that patients in the BLT group had a higher probability of achieving remission relative to patients in the DRL group [hazard ratio = 1.9 (95% CI = 1.1- 3.4), p = 0.026]. Further sensitivity analysis demonstrated greater improvement in 17-Hamilton Depression Score (group × time interaction, p = 0.04) in the BLT group for those who were adherent to light therapy.
CONCLUSIONS


The use of bright light therapy with gradual advance protocol is an effective adjunctive treatment resulting in quicker and a higher rate of remission of depression in patients with non-seasonal unipolar depression and evening-chronotype.",2020,"Further sensitivity analysis demonstrated greater improvement in 17-Hamilton Depression Score (group × time interaction, p = 0.04) in the BLT group for those who were adherent to light therapy.
","['patients with non-seasonal unipolar depression and evening-chronotype', 'Participants', 'A total of 93 participants (46.4 ± 11.7 years old, 80% female', 'unipolar major depressive disorder with evening chronotype ']","['bright white light therapy (BLT) or dim red light (DRL) with the same advancement protocol', 'Adjunctive bright light treatment', 'adjunctive bright light therapy', 'bright light therapy with gradual advance protocol']","['Time to remission', 'i) remission rate and (ii) the severity of depression', '17-Hamilton Depression Score', 'probability of achieving remission relative', 'cumulative remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521113', 'cui_str': 'Non-seasonal'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",93.0,0.243409,"Further sensitivity analysis demonstrated greater improvement in 17-Hamilton Depression Score (group × time interaction, p = 0.04) in the BLT group for those who were adherent to light therapy.
","[{'ForeName': 'Joey Wy', 'Initials': 'JW', 'LastName': 'Chan', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Lam', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Shirley X', 'Initials': 'SX', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Steven Wh', 'Initials': 'SW', 'LastName': 'Chau', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Chan', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'N Y', 'Initials': 'NY', 'LastName': 'Chan', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Wing', 'Affiliation': 'Sleep Assessment Unit, Department of Psychiatry, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China.'}]",Psychological medicine,['10.1017/S0033291720003232']
2605,32936370,Effects of a workplace exercise program on physical capacity and lower back symptoms in hospital nursing assistants: a randomized controlled trial.,"PURPOSE


Considering the relevance of muscle strength for sustaining good musculoskeletal health among workers who perform physically demanding work, the aim of this study was to evaluate the effectiveness of a therapeutic exercise program on muscle strength and low back symptoms among hospital nursing assistants.
METHODS


One hundred and twenty-nine nursing assistants filled out a questionnaire on personal, occupational information and health status, which allowed the identification of workers able to exercise. Ninety participants were randomly allocated to an intervention and a reference group. The therapeutic exercise program (TEP) lasted 12 weeks and included warm-up, strengthening and stretching exercises. Muscle strength of trunk flexors and trunk extensors, hamstring flexibility, and low back symptoms were evaluated before and after the intervention period by two blinded assessors. The comparison between groups was carried out using Mann-Whitney and χ 2  tests at a significance level of 0.05.
RESULTS


The average participation in the exercise program was 17.5 sessions. Results showed increased trunk flexors muscle strength (p = 0.002; effect size: 0.77), improved pressure pain threshold for dorsal longissimus (p = 0.001; effect size > 0.8), and reduced low back symptoms (p = 0.002; OR = 6.25). No differences between groups were identified for back extensor muscle strength or flexibility.
CONCLUSION


The exercise program applied is a feasible intervention which resulted clinically relevant results for nursing assistants' musculoskeletal health expressed through trunk flexors muscle strength improvement and low back symptoms control among nursing assistants. This RCT brings contribution to the Occupational Health field as the exercise program applied resulted in clinically relevant results for nursing assistants' musculoskeletal health. This study brings contribution especially for low-income and middle-income countries where low back pain and disability can be considered more severe as adequate resources to address the problem are scarce. Thus, we must highlight the importance of low-cost preventive strategies, like exercise programs carried out in hospital settings to avoid the progress of disability among active nursing personnel.",2020,"Results showed increased trunk flexors muscle strength (p = 0.002; effect size: 0.77), improved pressure pain threshold for dorsal longissimus (p = 0.001; effect size > 0.8), and reduced low back symptoms (p = 0.002; OR = 6.25).","['Ninety participants', 'One hundred and twenty-nine nursing assistants filled out a questionnaire on personal, occupational information and health status, which allowed the identification of workers able to exercise', 'hospital nursing assistants']","['workplace exercise program', 'therapeutic exercise program', 'therapeutic exercise program (TEP) lasted 12\xa0weeks and included warm-up, strengthening and stretching exercises']","['pressure pain threshold for dorsal longissimus', 'muscle strength and low back symptoms', 'back extensor muscle strength or flexibility', 'low back symptoms', 'Muscle strength of trunk flexors and trunk extensors, hamstring flexibility, and low back symptoms', 'physical capacity and lower back symptoms', 'trunk flexors muscle strength']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1271036', 'cui_str': 'Hospital nurse'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",90.0,0.0280023,"Results showed increased trunk flexors muscle strength (p = 0.002; effect size: 0.77), improved pressure pain threshold for dorsal longissimus (p = 0.001; effect size > 0.8), and reduced low back symptoms (p = 0.002; OR = 6.25).","[{'ForeName': 'Roberta F C', 'Initials': 'RFC', 'LastName': 'Moreira', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Rodovia Washington Luís, Km 235. São Carlos, São Paulo, 13565-905, Brazil. roberta.carreira@gmail.com.'}, {'ForeName': 'Cristiane S', 'Initials': 'CS', 'LastName': 'Moriguchi', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Rodovia Washington Luís, Km 235. São Carlos, São Paulo, 13565-905, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Carnaz', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Rodovia Washington Luís, Km 235. São Carlos, São Paulo, 13565-905, Brazil.'}, {'ForeName': 'Fabiana A', 'Initials': 'FA', 'LastName': 'Foltran', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Rodovia Washington Luís, Km 235. São Carlos, São Paulo, 13565-905, Brazil.'}, {'ForeName': 'Luciana C C B', 'Initials': 'LCCB', 'LastName': 'Silva', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Rodovia Washington Luís, Km 235. São Carlos, São Paulo, 13565-905, Brazil.'}, {'ForeName': 'Helenice J C G', 'Initials': 'HJCG', 'LastName': 'Coury', 'Affiliation': 'Physical Therapy Department, Federal University of São Carlos, Rodovia Washington Luís, Km 235. São Carlos, São Paulo, 13565-905, Brazil.'}]",International archives of occupational and environmental health,['10.1007/s00420-020-01572-z']
2606,32936371,The relationship between immune status as measured by stimulated ex-vivo tumour necrosis factor alpha levels and the acquisition of nosocomial infections in critically ill mechanically ventilated patients.,"INTRODUCTION


Immunological dysfunction is common in critically ill patients but its clinical significance and the optimal method to measure it are unknown. The level of tumor necrosis factor alpha (TNF-α) after ex-vivo whole blood stimulation with lipopolysaccharide (LPS) has been proposed as a possible method to quantify immunological function. We hypothesized that in a cohort of critically ill patients, those with a lower post-stimulation TNF-α level would have increased rates of nosocomial infections (NIs) and worse clinical outcomes.
METHODS


A secondary analysis of a phase 2 randomized, multi-centre, double-blinded placebo-controlled trial. As there was no difference between treatment and control arms in outcomes and NI rate, all the patients were analyzed as one cohort. On enrolment, day 4, 7, and weekly until day 28, whole blood was incubated with LPS ex-vivo and subsequent TNF-α level was measured. Patients were grouped in tertiles according to delta and peak TNF-α level. The primary outcome was the association between NIs and tertiles of TNF-α level post LPS stimulation; secondary outcomes included ICU and 90-day mortality, and ICU and hospital length of stay.
RESULTS


Data was available for 201 patients. Neither the post LPS stimulation delta TNF-α group nor the peak TNF-α post-stimulation group were associated with the development of NIs or clinical outcomes. Patients in the highest tertile for post LPS stimulation delta TNF-α compared to the lowest tertile were younger [61.1 years ± 15.7 vs. 68.6 years ± 12.8 standard deviations (SD) in the lowest tertile], had lower acuity of illness (APACHE II 25.0 ± 9.7 vs. 26.7 ± 6.1) and had lower baseline TNF-α (9.9 pg/mL ± 19.0 vs. 31.0 pg/mL ± 68.5). When grouped according to peak post-stimulation TNF-α levels, patients in the highest tertile had higher serum TNF-α at baseline (21.3 pg/mL ± 66.7 compared to 6.5 pg/mL ± 9.0 in the lowest tertile).
CONCLUSION


In this prospective multicenter study, ex-vivo stimulated TNF-α level was not associated with the occurrence of NIs or clinical outcomes. Further study is required to better ascertain whether TNF levels and ex-vivo stimulation can be used to characterize immune function in critical illness and if other assays might be better suited to this task.",2020,"TNF-α compared to the lowest tertile were younger [61.1 years ± 15.7 vs. 68.6 years ± 12.8 standard deviations (SD) in the lowest tertile], had lower acuity of illness (APACHE II 25.0 ± 9.7 vs. 26.7 ± 6.1) and had lower baseline TNF-α (9.9 pg/mL ± 19.0 vs. 31.0 pg/mL ± 68.5).","['critically ill mechanically ventilated patients', '201 patients', 'critically ill patients']","['lipopolysaccharide (LPS', 'placebo', 'TNF-α']","['LPS stimulation delta', 'level of tumor necrosis factor alpha (TNF-α', 'association between NIs and tertiles of TNF-α level post LPS stimulation; secondary outcomes included ICU and 90-day mortality, and ICU and hospital length of stay', 'serum TNF-α']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.1302,"TNF-α compared to the lowest tertile were younger [61.1 years ± 15.7 vs. 68.6 years ± 12.8 standard deviations (SD) in the lowest tertile], had lower acuity of illness (APACHE II 25.0 ± 9.7 vs. 26.7 ± 6.1) and had lower baseline TNF-α (9.9 pg/mL ± 19.0 vs. 31.0 pg/mL ± 68.5).","[{'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Levin', 'Affiliation': 'Kingston Health Sciences Center, Kingston, Ontario, Canada.'}, {'ForeName': 'J Gordon', 'Initials': 'JG', 'LastName': 'Boyd', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Watkins C, 76 Stuart Street, Kingston, Ontario, K7L 2V3, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Day', 'Affiliation': 'Kingston Health Sciences Center, Kingston, Ontario, Canada.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Hunt', 'Affiliation': 'Kingston Health Sciences Center, Kingston, Ontario, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maslove', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Watkins C, 76 Stuart Street, Kingston, Ontario, K7L 2V3, Canada.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Norman', 'Affiliation': 'Kingston Health Sciences Center, Kingston, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': ""O'Callaghan"", 'Affiliation': 'Kingston Health Sciences Center, Kingston, Ontario, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sibley', 'Affiliation': 'Kingston Health Sciences Center, Kingston, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Watkins C, 76 Stuart Street, Kingston, Ontario, K7L 2V3, Canada. John.Muscedere@kingstonhsc.ca.""}]",Intensive care medicine experimental,['10.1186/s40635-020-00344-w']
2607,32936416,"A Multimorbidity-Based, Risk-Stratified Reanalysis of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Trial.","INTRODUCTION


Multimorbidity is common in patients with cardiovascular disease. Clinical trials in cardiovascular medicine mostly enroll patients who are younger, healthier, and more affluent than average patients with the condition of interest. These trials rarely account for patient-level multimorbidity in a systematic fashion. Further, treatment effect heterogeneity is usually tested across subgroups of patients based on the presence or absence of individual variables, not on the basis of summative risk scores that account for multimorbidity. Thus, the impact of multimorbidity on treatment effects is poorly understood.
METHODS


In this study, we performed a multimorbidity-based risk-stratified reanalysis of the AFFIRM (Atrial Fibrillation Follow-Up Investigation of Rhythm Management) trial. Our objectives were to describe the distribution of multimorbidity using a modified version of the Charlson Comorbidity Index (mCCI), scale 0-14, and to assess its impact on the original primary endpoint of all-cause mortality.
RESULTS


The majority of patients in the AFFIRM trial had an mCCI score of ≤  4 (55.5%), and there was no statistically significant difference in the risk of death for rate versus rhythm control in these patients (7.9 vs. 8.8%; p = 0.44). However, for patients with an mCCI ≥ 5 (44.5%), there was a strong trend toward a reduction in death with rate control that nearly reached statistical significance despite being underpowered (24.5 vs. 28.3%; p = 0.07).
CONCLUSION


This proof-of-concept study supports the idea that clinical trials in cardiovascular medicine should systematically assess for multimorbidity and investigate its potential impact on treatment effects.",2020,"The majority of patients in the AFFIRM trial had an mCCI score of ≤  4 (55.5%), and there was no statistically significant difference in the risk of death for rate versus rhythm control in these patients (7.9 vs. 8.8%; p = 0.44).","['patients with cardiovascular disease', 'cardiovascular medicine mostly enroll patients who are younger, healthier, and more affluent than average patients with the condition of interest']",[],"['mCCI score', 'risk of death for rate versus rhythm control', 'death with rate control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0846487,"The majority of patients in the AFFIRM trial had an mCCI score of ≤  4 (55.5%), and there was no statistically significant difference in the risk of death for rate versus rhythm control in these patients (7.9 vs. 8.8%; p = 0.44).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ruzieh', 'Affiliation': 'Penn State College of Medicine, Penn State Heart and Vascular Institute, 500 University Drive, PO Box 850 H047, Hershey, PA, 17033-0850, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Cardiology Group, Louisville, KY, USA.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Penn State College of Medicine, Penn State Heart and Vascular Institute, 500 University Drive, PO Box 850 H047, Hershey, PA, 17033-0850, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Foy', 'Affiliation': 'Penn State College of Medicine, Penn State Heart and Vascular Institute, 500 University Drive, PO Box 850 H047, Hershey, PA, 17033-0850, USA. afoy@pennstatehealth.psu.edu.'}]",Drugs & aging,['10.1007/s40266-020-00797-4']
2608,32936427,Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study.,"BACKGROUND


Painful diabetic neuropathy is an important therapeutic challenge as the efficacy of analgesic drugs in this setting is still unsatisfactory. Monotherapy with available treatments is often not sufficient and a combination of drugs is necessary. Trazodone (TRZ) is a compound with a multi-modal mechanism of action, being a serotonin-2 antagonist/reuptake inhibitor developed and approved for the treatment of depression in several countries. Previous clinical trials suggest a possible beneficial effect of low doses of trazodone for the treatment of patients affected by painful diabetic neuropathy.
OBJECTIVE


This phase II study was designed to collect data on the efficacy and safety of low doses of TRZ combined with gabapentin after 8 weeks of treatment in patients affected by painful diabetic neuropathy.
METHODS


This was a randomized, double-blind, placebo-controlled, multi-center, international, prospective study. Male and female diabetic patients aged 18-75 years and affected by painful diabetic neuropathy were eligible for enrollment. Subjects were randomized (1:1:1 ratio) to TRZ30 (10 mg three times daily for 8 weeks) or TRZ60 (20 mg three times daily for 8 weeks) or placebo. Gabapentin as background therapy was administered in open-label conditions to all patients. The primary endpoint was the change from baseline of the Brief Pain Inventory Short Form item 5 to week 8. Secondary endpoints included the other Brief Pain Inventory Short Form items, and the assessment of anxiety, sleep, quality of life, patient's improvement, and safety.
RESULTS


One hundred and forty-one patients were included in the intention-to-treat population: 43 allocated to the TRZ30 group, 50 to the TRZ60 group, and 48 to the placebo group. After 8 weeks, the mean changes of Brief Pain Inventory Short Form item 5 from baseline were - 3.1, - 2.6, and - 2.5 in the TRZ30, TRZ60, and placebo groups, respectively. No statistically significant differences between groups were seen. Nevertheless, a better trend was observed for TRZ30 vs placebo (95% confidence interval - 1.30, 0.15; p = 0.1179), on top of the background effect of gabapentin administered to all study groups. 62.8% of patients achieved a ≥ 50% reduction in the TRZ30 group, 54% in the TRZ60 group, and 45.8% in the placebo group. At the same time, a statistically significant improvement was observed in Brief Pain Inventory Short Form item 6 for TRZ30 vs placebo (95% confidence interval - 1.54, - 0.07; p = 0.0314). No serious adverse event occurred during the trial and the most frequent treatment-emergent adverse events involved nervous system, QT prolongation, and gastrointestinal disorders.
CONCLUSIONS


All treatment groups showed a clinically meaningful pain improvement; nevertheless, patients in the TRZ30 treatment group reported better efficacy outcomes. This finding suggests that low doses of TRZ could be useful for treating painful diabetic neuropathy, and support further adequately powered confirmatory trials investigating the efficacy of TRZ.
CLINICAL TRIAL REGISTRATION


NCT03202979, date of registration: 29/06/2017.",2020,"No serious adverse event occurred during the trial and the most frequent treatment-emergent adverse events involved nervous system, QT prolongation, and gastrointestinal disorders.
","['Male and female diabetic patients aged 18-75\xa0years and affected by painful diabetic neuropathy were eligible for enrollment', 'patients affected by painful diabetic neuropathy', 'Patients Affected by Painful Diabetic Neuropathy and Treated with', 'One hundred and forty-one patients were included in the intention-to-treat population: 43 allocated to the']","['Gabapentin', 'TRZ30', 'TRZ', 'TRZ combined with gabapentin', 'gabapentin', 'placebo', 'TRZ30 vs placebo', 'Trazodone (TRZ', 'trazodone', 'Trazodone', 'Monotherapy', 'TRZ60']","['Brief Pain Inventory', 'nervous system, QT prolongation, and gastrointestinal disorders', 'efficacy outcomes', 'efficacy and safety', 'change from baseline of the Brief Pain Inventory Short Form item 5 to week 8', 'Efficacy and Safety', 'serious adverse event', 'mean changes of Brief Pain Inventory', ""other Brief Pain Inventory Short Form items, and the assessment of anxiety, sleep, quality of life, patient's improvement, and safety"", 'clinically meaningful pain improvement']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027763', 'cui_str': 'Structure of nervous system'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4039089', 'cui_str': 'Assessment of anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",141.0,0.475083,"No serious adverse event occurred during the trial and the most frequent treatment-emergent adverse events involved nervous system, QT prolongation, and gastrointestinal disorders.
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lipone', 'Affiliation': 'Angelini Pharma S.p.A., Viale Amelia 70, Rome, Italy.'}, {'ForeName': 'Edvard', 'Initials': 'E', 'LastName': 'Ehler', 'Affiliation': 'Neurological Unit, Regional Hospital Pardubice, Pardubice, Czech Republic.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Nastaj', 'Affiliation': 'NZOZ Neuromed M. i M. Nastaj Sp. P., Lublin, Poland.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Palka-Kisielowska', 'Affiliation': 'Silmedic Sp. z o.o., Katowice, Poland.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cruccu', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy. giorgio.cruccu@uniroma1.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Truini', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Di Loreto', 'Affiliation': 'Angelini Pharma S.p.A., Viale Amelia 70, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Vecchio', 'Affiliation': 'Angelini Pharma S.p.A., Viale Amelia 70, Rome, Italy.'}, {'ForeName': 'Ilena', 'Initials': 'I', 'LastName': 'Pochiero', 'Affiliation': 'Angelini Pharma S.p.A., Viale Amelia 70, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini Pharma S.p.A., Viale Amelia 70, Rome, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': 'Angelini Pharma S.p.A., Viale Amelia 70, Rome, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Cattaneo', 'Affiliation': 'Angelini Pharma S.p.A., Viale Amelia 70, Rome, Italy.'}]",CNS drugs,['10.1007/s40263-020-00760-2']
2609,32931400,"Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy: Investigator-Initiated, Randomized, Open-Label Trial.","PURPOSE


Chemotherapy-induced nausea and vomiting (CINV) is a significant toxicity of chemotherapy. Olanzapine is recommended in adult patients for the prevention of CINV but has not been prospectively investigated in children.
METHODS


This investigator-initiated, randomized, open-label trial evaluated olanzapine in children (ages 5-18 years) scheduled to receive the first cycle of highly emetogenic chemotherapy (HEC). All participants received aprepitant, ondansetron, and dexamethasone during and 2 days after chemotherapy. Participants in the study group additionally received oral olanzapine 0.14 mg/kg/day (rounded to the nearest 2.5 mg; maximum, 10 mg) during the chemotherapy block and 3 days postchemotherapy. The primary objective was to compare complete response (CR) rates (no vomiting and no rescue medication) between the groups in the acute, delayed, and overall periods. Nausea comparison and safety evaluation were secondary and additional objectives, respectively. The collection of outcomes and adverse events was performed daily until the completion of the overall period.
RESULTS


A total of 240 patients underwent randomization. We performed a modified intention-to-treat analysis on 231 patients (116 in the control group and 115 in the study group). A higher proportion of patients in the olanzapine group achieved CR in the acute period (78%  v  59%;  P  = .001), delayed period (74%  v  47%;  P  < .001) and overall period (64%  v  38%;  P  < .001) than in the control group. The proportion of patients with no nausea was significantly higher in the olanzapine group in the acute period (74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001). Grade 1/2 somnolence was greater in the olanzapine group (35%  v  11%;  P  < .001). There was no grade 3/4 somnolence reported.
CONCLUSION


Olanzapine significantly improved CR rates for vomiting in children receiving the first cycle of HEC.",2020,"74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001).","['children (ages 5-18 years', 'children receiving the first cycle of HEC', 'adult patients', '240 patients underwent randomization', 'Children and Adolescents Receiving Highly Emetogenic Chemotherapy', '231 patients (116 in the control group and 115 in the study group']","['olanzapine', 'chemotherapy block and 3 days postchemotherapy', 'Olanzapine', 'aprepitant, ondansetron, and dexamethasone', 'oral olanzapine', 'emetogenic chemotherapy (HEC']","['complete response (CR) rates (no vomiting and no rescue medication', 'Vomiting', 'nausea and vomiting (CINV', 'proportion of patients with no nausea', 'Nausea comparison and safety evaluation', 'CR rates for vomiting', 'Grade 1/2 somnolence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",240.0,0.111181,"74%  v  52%;  P  < .001), delayed period (74%  v  47%;  P  < .001), and overall period (64%  v  37%;  P  < .001).","[{'ForeName': 'Ramavath D', 'Initials': 'RD', 'LastName': 'Naik', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashwati S', 'Initials': 'AS', 'LastName': 'Pillai', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dhawan', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00871']
2610,32931412,Iron supplementation limits the deleterious effects of repeated blood donation on endurance sport performance but not on iron status.,"BACKGROUND


Every day, blood banks worldwide face the challenge of ensuring an adequate blood supply. Iron deficiency is by far the most common cause of deferral of blood donors. The aim of the present study was to determine the effect of iron supplementation after repeated blood donation on iron status and physiological performance.
MATERIALS AND METHODS


Forty-four moderately trained and iron-replete subjects were randomly divided into a whole blood donation (n=36) and a placebo donation (n=8) group. One third of the donation group received no iron supplementation, whereas one third received 20 mg iron and one third received 80 mg iron daily for 28 days. The subjects were intended to make three donations 3 months apart, and recovery of endurance capacity, assessed by an incremental maximal cycling test, and haematological parameters was monitored up to 28 days after each donation.
RESULTS


Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers. Iron supplementation did not affect iron storage but did limit, at the highest dose of 80 mg, the effect of blood donations on functional iron and/or iron metabolism regulation, and at both 20 and 80 mg the negative effects on maximal power output and peak oxygen consumption.
DISCUSSION


Iron supplementation limited the deleterious effects of repeated blood donation on endurance sport performance but not on decline in iron status in iron-replete young men. These results underline the importance of iron supplementation to minimise the deleterious effects of blood donation on physiological functions, and the necessity to optimise the supplementation strategy to preserve iron status.",2020,"RESULTS


Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers.","['Forty-four moderately trained and iron-replete subjects', 'iron-replete young men']","['no iron supplementation', 'iron supplementation', 'placebo donation', 'whole blood donation']","['maximal power output and peak oxygen consumption', 'endurance sport performance', 'functional iron and/or iron metabolism regulation', 'markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",44.0,0.129808,"RESULTS


Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pachikian', 'Affiliation': 'Centre of Investigation in Clinical Nutrition, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Naslain', 'Affiliation': 'Institute of Neuroscience, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Benoit', 'Affiliation': 'Institute of Neuroscience, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Brebels', 'Affiliation': 'Institute of Neuroscience, UCLouvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Van Asch', 'Affiliation': 'Belgian Red Cross-Flanders, Mechelen, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Compernolle', 'Affiliation': 'Belgian Red Cross-Flanders, Mechelen, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Vandekerckhove', 'Affiliation': 'Belgian Red Cross-Flanders, Mechelen, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Deldicque', 'Affiliation': 'Centre of Investigation in Clinical Nutrition, UCLouvain, Louvain-la-Neuve, Belgium.'}]",Blood transfusion = Trasfusione del sangue,['10.2450/2020.0087-20']
2611,32931457,Yoga-Based Relaxation Technique Facilitates Sustained Attention in Patients with Low Back Pain: A Pilot Study.,"Context


The experience of pain strongly influences sustained attention, which is important for neurocognitive performance. Yoga-based relaxation techniques may be effective in improving sustained attention by attenuating pain in patients with low back pain. Hence, we aimed to investigate the effect of a yoga-based relaxation technique on sustained attention and self-reported pain disability in patients with low back pain.
Methods


A total of 22 men aged 30 to 50 years with low back pain were recruited for the study. They were randomly assigned to either the yoga (n = 11) or control (n = 11) groups. The yoga group practiced a yoga-based relaxation technique (YBRT) 1 hour a day for 4 weeks and the control group maintained their usual physical activity regimen. Assessments included the Sustained Attention to Response Task (SART) and the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) measured before and after the 4-week intervention.
Results


The study showed a significant reduction in all self-reported OLBPDQ domains and improvement in sustained attention in a before and after comparison 4 weeks following the yoga intervention. Pearson's correlation also showed a positive correlation between sustained attention and pain reduction following the yoga intervention.
Conclusion


The findings indicate that yoga practice reduces pain and simultaneously improves information processing speed with impulse control during the performance of a sustained attention task.",2020,Yoga-based relaxation techniques may be effective in improving sustained attention by attenuating pain in patients with low back pain.,"['Patients with Low Back Pain', '22 men aged 30 to 50 years with low back pain were recruited for the study', 'patients with low back pain']","['Yoga-Based Relaxation Technique', 'Yoga-based relaxation techniques', 'yoga-based relaxation technique', 'yoga group practiced a yoga-based relaxation technique (YBRT']","['pain reduction', 'sustained attention and self-reported pain disability', 'Sustained Attention to Response Task (SART) and the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ', 'OLBPDQ domains and improvement in sustained attention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",22.0,0.0391434,Yoga-based relaxation techniques may be effective in improving sustained attention by attenuating pain in patients with low back pain.,"[{'ForeName': 'Dwivedi', 'Initials': 'D', 'LastName': 'Krishna', 'Affiliation': ''}, {'ForeName': 'Singh', 'Initials': 'S', 'LastName': 'Deepeshwar', 'Affiliation': ''}, {'ForeName': 'Bharati', 'Initials': 'B', 'LastName': 'Devi', 'Affiliation': ''}]",Advances in mind-body medicine,[]
2612,32925256,Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus: comparison of ipsilateral diaphragmatic function: A randomised clinical trial.,"BACKGROUND


The ultrasound-guided retroclavicular block (RCB) is a recently described alternative approach to brachial plexus blockade at the level of the cords. Although more distal blockade of the brachial plexus is thought to be associated with a lower incidence of phrenic nerve block, the impact of RCB on ipsilateral diaphragmatic function has not been formally investigated.
OBJECTIVE


To compare the effects of supraclavicular and retroclavicular brachial plexus block on diaphragmatic function.
SETTING


A single tertiary hospital, study period from December 2017 to May 2019.
DESIGN


Double-blinded, randomised study.
PATIENTS


A total of 40 patients undergoing upper extremity surgery below the axilla. Exclusion criteria included significant pulmonary disease, BMI more than 40 and contra-indication to peripheral nerve block.
INTERVENTIONS


Patients were randomised to supraclavicular or retroclavicular brachial plexus block with ropivacaine 0.5%.
OUTCOME MEASURES


Phrenic block was assessed by measuring changes in diaphragmatic excursion using M-mode ultrasound, and maximum inspiratory volume on incentive spirometry from baseline, at 15 and 30 min postblock, and postoperatively. Comparative assessment of block characteristics included timing and distribution of sensory and motor block onset in the upper extremity, and scanning and block performance times.
RESULTS


The incidence of phrenic block in the supraclavicular group was higher by ultrasound imaging (70 vs. 15%) and also by pulmonary function testing (55 vs. 5%), with both diaphragmatic excursion and maximum inspiratory volume decreasing to a greater extent after supraclavicular block (SCB) compared with RCB at 15, 30 min and postoperative time points (repeated measures analysis of variance, P < 0.001). There was no difference in timing and extent of distal arm block, but suprascapular and axillary nerves were more consistently blocked after SCB than after RCB.
CONCLUSION


The current study confirms the hypothesis that a RCB is significantly less likely to affect ipsilateral diaphragmatic function than a SCB.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02631122 https://clinicaltrials.gov/ct2/show/NCT02631122.",2020,"The incidence of phrenic block in the supraclavicular group was higher by ultrasound imaging (70 vs. 15%) and also by pulmonary function testing (55 vs. 5%), with both diaphragmatic excursion and maximum inspiratory volume decreasing to a greater extent after supraclavicular block (SCB) compared with RCB at 15, 30 min and postoperative time points (repeated measures analysis of variance, P < 0.001).","['A total of 40 patients undergoing upper extremity surgery below the axilla', 'A single tertiary hospital, study period from December 2017 to May 2019']","['supraclavicular or retroclavicular brachial plexus block with ropivacaine 0.5', 'ultrasound-guided retroclavicular block (RCB', 'ipsilateral diaphragmatic function', 'Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus', 'supraclavicular and retroclavicular brachial plexus block']","['ipsilateral diaphragmatic function', 'timing and extent of distal arm block, but suprascapular and axillary nerves', 'incidence of phrenic block', 'Phrenic block', 'diaphragmatic excursion and maximum inspiratory volume']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006090', 'cui_str': 'Brachial plexus structure'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",40.0,0.221411,"The incidence of phrenic block in the supraclavicular group was higher by ultrasound imaging (70 vs. 15%) and also by pulmonary function testing (55 vs. 5%), with both diaphragmatic excursion and maximum inspiratory volume decreasing to a greater extent after supraclavicular block (SCB) compared with RCB at 15, 30 min and postoperative time points (repeated measures analysis of variance, P < 0.001).","[{'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Georgiadis', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'Kamen V', 'Initials': 'KV', 'LastName': 'Vlassakov', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patton', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'Philipp B', 'Initials': 'PB', 'LastName': 'Lirk', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janfaza', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Zeballos', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'Aurora N', 'Initials': 'AN', 'LastName': 'Quaye', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Schreiber', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA (PLG, KVV, MEP, PBL, DRJ, JLZ, ANQ, VP, KLS).""}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001305']
2613,32925287,"Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5.","BACKGROUND


Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study.
METHODS


MEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs. non-China).
RESULTS


Of 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% (P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52.
CONCLUSIONS


Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02896127; https://clinicaltrials.gov/ct2/show/NCT02896127?term=NCT02896127&draw=2&rank=1.",2020,All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52.,"['Eligible patients', '458 patients (secukinumab 150 mg', 'patients with ankylosing spondylitis (AS', 'patients with AS from the MEASURE 5 study', '305; placebo, N\u200a=\u200a153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China']","['Secukinumab', 'placebo', 'secukinumab', 'subcutaneous secukinumab 150 mg or placebo']","['signs and symptoms of ankylosing spondylitis', 'SpondyloArthritis international Society (ASAS', 'ASAS20 response', 'Efficacy and safety', 'tolerated and the safety profile', 'signs and symptoms of AS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4517679', 'cui_str': '28.6'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",458.0,0.232244,All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52.,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': ""Department of Rheumatology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': ""Department of Rheumatology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Wei-Guo', 'Initials': 'WG', 'LastName': 'Wan', 'Affiliation': 'Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Wu', 'Affiliation': ""Department of Rheumatology & Immunology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang 830001, China.""}, {'ForeName': 'Ling-Li', 'Initials': 'LL', 'LastName': 'Dong', 'Affiliation': 'Department of Rheumatology & Immunology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology & Immunology, Guangdong General Hospital, Guangzhou, Guangdong 510000, China.'}, {'ForeName': 'Tae-Hwan', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sengupta', 'Affiliation': 'Royal National Hospital for Rheumatic Disease, Upper Borough Walls, Bath BA1 1RL, UK.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Šenolt', 'Affiliation': 'Institute of Rheumatology, Prague, Czech Republic.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Hao-Min', 'Initials': 'HM', 'LastName': 'Qiu', 'Affiliation': 'China Novartis Institutes for Biomedical Research, Shanghai 201203, China.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Haemmerle', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Chinese medical journal,['10.1097/CM9.0000000000001099']
2614,32925337,A Single Prophylactic Dose of Ondansetron Given at Cessation of Postoperative Propofol Sedation Decreases Postoperative Nausea and Vomiting in Cardiac Surgery Patients: A Randomized Controlled Trial.,"BACKGROUND


Postoperative nausea and vomiting (PONV) is a common occurrence after cardiac surgery. However, in contrast to other surgical populations, routine PONV prophylaxis is not a standard of care in cardiac surgery. We hypothesized that routine administration of a single prophylactic dose of ondansetron (4 mg) at the time of stopping postoperative propofol sedation before extubation in the cardiac surgery intensive care unit would decrease the incidence of PONV.
METHODS


With institutional human ethics board approval and written informed consent, we conducted a randomized controlled trial in patients ≥19 years of age with no history of PONV undergoing elective or urgent cardiac surgery procedures requiring cardiopulmonary bypass. The primary outcome was the incidence of PONV in the first 24 hours postextubation, compared by the χ test. Secondary outcomes included the incidence and times to first dose of rescue antiemetic treatment administration, the incidence of headaches, and the incidence of ventricular arrhythmias.
RESULTS


PONV within the first 24 hours postextubation occurred in 33 of 77 patients (43%) in the ondansetron group versus 50 of 82 patients (61%) in the placebo group (relative risk, 0.70 [95% confidence interval {CI}, 0.51-0.95]; absolute risk difference, -18% [95% CI, -33 to -2]; number needed to treat, 5.5 [95% CI, 3.0-58.4]; χ test, P = .022). Kaplan-Meier ""survival"" analysis of the times to first rescue antiemetic treatment administration over 24 hours indicated that patients in the ondansetron group fared better than those in the placebo group (log-rank [Mantel-Cox] test; P = .028). Overall, 32 of 77 patients (42%) in the ondansetron group received rescue antiemetic treatment over the first 24 hours postextubation versus 47 of 82 patients (57%) in the placebo group (relative risk, 0.73 [95% CI, 0.52-1.00]; absolute risk difference, -16% [95% CI, -31 to 1]); P = .047. There were no significant differences between the groups in the incidence of postoperative headache (ondansetron group, 5 of 77 patients [6%] versus placebo group, 4 of 82 patients [5%]; Fisher exact test; P = .740) or ventricular arrhythmias (ondansetron group, 2 of 77 patients [3%] versus placebo group, 4 of 82 patients [5%]; P = .68).
CONCLUSIONS


These findings support the routine administration of ondansetron prophylaxis at the time of discontinuation of postoperative propofol sedation before extubation in patients following cardiac surgery. Further research is warranted to optimize PONV prophylaxis in cardiac surgery patients.",2020,"There were no significant differences between the groups in the incidence of postoperative headache (ondansetron group, 5 of 77 patients [6%] versus placebo group, 4 of 82 patients [5%];","['cardiac surgery patients', 'patients ≥19 years of age with no history of PONV undergoing elective or urgent cardiac surgery procedures requiring cardiopulmonary bypass', 'Cardiac Surgery Patients', 'patients following cardiac surgery']","['ondansetron prophylaxis', 'placebo', 'Ondansetron', 'ondansetron', 'Propofol Sedation']","['incidence of postoperative headache', 'PONV', 'Postoperative Nausea and Vomiting', 'incidence and times to first dose of rescue antiemetic treatment administration, the incidence of headaches, and the incidence of ventricular arrhythmias', 'rescue antiemetic treatment', 'incidence of PONV in the first 24 hours postextubation', 'ventricular arrhythmias']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",,0.566015,"There were no significant differences between the groups in the incidence of postoperative headache (ondansetron group, 5 of 77 patients [6%] versus placebo group, 4 of 82 patients [5%];","[{'ForeName': 'Erica H Z', 'Initials': 'EHZ', 'LastName': 'Wang', 'Affiliation': ""From the Pharmacy Department, St Paul's Hospital, Providence Health Care, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sunderland', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nicola Y', 'Initials': 'NY', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesia, St Paul's Hospital, Providence Health Care, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Navraj S', 'Initials': 'NS', 'LastName': 'Chima', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Cynthia H', 'Initials': 'CH', 'LastName': 'Yarnold', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephan K W', 'Initials': 'SKW', 'LastName': 'Schwarz', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Coley', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004730']
2615,32925342,"The Effects of a Shoulder Roll During Laryngoscopy in Infants: A Randomized, Single-Blinded, Crossover Study.","BACKGROUND


The use of a shoulder roll to view the glottic opening during direct laryngoscopy in infants has been recommended but is not evidence based.
METHODS


Twenty infants with normal airways, <6 months of age undergoing elective surgery under general anesthesia were randomized to undergo direct laryngoscopy first with a 2-inch vertical shoulder roll and then without, or vice versa. The primary outcome was the difference in the vertical distance between the angle of the laryngoscopist's eye and the operating room table in the 2 positions. Also, the views of the glottic opening in both positions were recorded for each infant and analyzed by a blinded investigator using the percent of glottic opening (POGO).
RESULTS


Twenty infants completed the study without complications. The vertical distance did not differ significantly whether the shoulder roll was placed first or second, and there was no evidence of a differential carryover effect in the crossover design (P = .268). The main effect of the shoulder roll on the mean (95% confidence interval [CI]) vertical distances without 47.8 cm (43.5-52.1) and with the shoulder roll 37.2 cm (33.3-41) yielded a mean (95% CI) vertical difference of 10.6 cm (9.3-11.79; P = .0001). The median (interquartile range [IQR]) POGO scores without 100 [86.2, 100] and with the shoulder roll 97.5 [80, 100] did not differ (median difference [95% CI]: 0 [-20 to 0]; P = .39).
CONCLUSIONS


A 2-inch shoulder roll lowers the line of sight of the glottic opening compared with no shoulder roll, without affecting the view of the glottic opening during laryngoscopy in infants.",2020,"The vertical distance did not differ significantly whether the shoulder roll was placed first or second, and there was no evidence of a differential carryover effect in the crossover design (P = .268).","['Twenty infants with normal airways, <6 months of age undergoing elective surgery under general anesthesia', 'Twenty infants completed the study without complications', 'Infants']","['direct laryngoscopy first with a 2-inch vertical shoulder roll and then without, or vice versa', 'Shoulder Roll']","['median (interquartile range [IQR]) POGO scores', ""vertical distance between the angle of the laryngoscopist's eye and the operating room table in the 2 positions"", 'vertical distance']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0450394', 'cui_str': '2 inch'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",20.0,0.278582,"The vertical distance did not differ significantly whether the shoulder roll was placed first or second, and there was no evidence of a differential carryover effect in the crossover design (P = .268).","[{'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Alfahel', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Gopinath', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}, {'ForeName': 'Kristopher L', 'Initials': 'KL', 'LastName': 'Arheart', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of Miami School of Medicine, Miami, Florida.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Gensler', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}, {'ForeName': 'Jerrold', 'Initials': 'J', 'LastName': 'Lerman', 'Affiliation': ""From the Department of Anesthesia, John R. Oishei Children's Hospital, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004802']
2616,32925344,ADAPT-2: A Randomized Clinical Trial to Reduce Intraoperative EEG Suppression in Older Surgical Patients Undergoing Major Noncardiac Surgery.,"BACKGROUND


Recent limited evidence suggests that the use of a processed electroencephalographic (EEG) monitor to guide anesthetic management may influence postoperative cognitive outcomes; however, the mechanism is unclear.
METHODS


This exploratory, single-center, randomized clinical trial included patients who were ≥65 years of age undergoing elective noncardiac surgery. The study aimed to determine whether monitoring the brain using a processed EEG monitor reduced EEG suppression and subsequent postoperative delirium. The interventional group received processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA), while the standard care group was also monitored, but the EEG data were blinded from the clinicians. The primary outcome was intraoperative EEG suppression. A secondary outcome was incident postoperative delirium during the first 3 days after surgery.
RESULTS


All outcomes were analyzed using the intention-to-treat paradigm. Two hundred and four patients with a mean age of 72 ± 5 years were studied. Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]). The effect of the intervention on EEG suppression differed for those with and without preoperative cognitive impairment (interaction P = .01), with the estimated incidence rate ratio (95% CI) of 0.39 (0.33-0.44) for those with preoperative cognitive impairment and 0.48 (0.44-0.51) for those without preoperative cognitive impairment. The incidence of delirium was not found to be different between the interventional (17%) and the standard care groups (20%), risk ratio = 0.85 (95% CI, 0.47-1.5).
CONCLUSIONS


The use of processed EEG to maintain the PSI >35 was associated with less time spent in intraoperative EEG suppression. Preoperative cognitive impairment was associated with a greater percent of surgical time spent in EEG suppression. A larger prospective cohort study to include more cognitively vulnerable patients is necessary to show whether an intervention to reduce EEG suppression is efficacious in reducing postoperative delirium.",2020,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","['Two hundred and four patients with a mean age of 72 ± 5 years were studied', 'Older Surgical Patients Undergoing Major Noncardiac Surgery', 'patients who were ≥65 years of age undergoing elective noncardiac surgery', 'cognitively vulnerable patients']","['ADAPT-2', 'Intraoperative EEG Suppression', 'processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA']","['EEG suppression and subsequent postoperative delirium', 'incidence rate ratio', 'Minutes of EEG suppression adjusted by the length of surgery', 'incident postoperative delirium', 'Preoperative cognitive impairment', 'intraoperative EEG suppression', 'incidence of delirium', 'EEG suppression']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",204.0,0.158331,"Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Tang', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Zhongnan', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Sands', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Pleasants', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sanam', 'Initials': 'S', 'LastName': 'Tabatabai', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Center for Gerontology and Department of Statistics, Virginia Tech, Blacksburg, VA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Leung', 'Affiliation': 'From the Department of Anesthesia & Perioperative Care, University of California, San Francisco, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004713']
2617,32925494,Interrupting Prolonged Sitting and Endothelial Function in Polycystic Ovary Syndrome.,"PURPOSE


In healthy adults, the impairment of vascular function associated with prolonged sitting can be mitigated with intermittent brief bouts of activity. It is unknown whether these benefits extend to women with polycystic ovary syndrome (PCOS), in whom vascular function is typically impaired and sitting time is high. We examined the acute impact of regularly interrupting sitting time with brief simple resistance activities (SRAs) on vascular function in PCOS.
METHODS


In a randomized crossover trial, 13 physically inactive women with PCOS (18-45 years) completed two 3.5h conditions: 1) uninterrupted sitting (SIT) and 2) sitting interrupted by 3-min bouts of SRAs every 30 min. Femoral artery flow-mediated dilation (FMD), resting shear rate and resting blood flow were measured at 0h, 1h and 3.5h.
RESULTS


Mean resting femoral shear rate, averaged across the 3.5h, significantly increased in the SRA condition relative to the SIT condition (40.1 ± 6.1/s vs 62.8 ± 6.1/s, P < 0.0001). In addition, mean resting blood flow also significantly increased across the 3.5h for SRA relative to SIT (45.0 ± 9.8 ml/min vs 72.8 ± 9.9 ml/min, P < 0.0001). There were no differences between conditions in the temporal change in femoral artery FMD across 3.5h (Ptime x condition > 0.05 for all).
CONCLUSION


Frequently interrupting sitting with SRAs acutely increased resting shear rate and blood flow in women with PCOS, but did not alter FMD. With sedentary behavior increasing in prevalence, longer term studies of similar interventions to reduce and break up sitting time are warranted.",2020,"There were no differences between conditions in the temporal change in femoral artery FMD across 3.5h (Ptime x condition > 0.05 for all).
","['women with polycystic ovary syndrome (PCOS', '13 physically inactive women with PCOS (18-45 years) completed two 3.5h conditions: 1', 'healthy adults', 'women with PCOS', 'Polycystic Ovary Syndrome']","['regularly interrupting sitting time with brief simple resistance activities (SRAs', 'uninterrupted sitting (SIT) and 2) sitting interrupted by 3-min bouts of SRAs every 30 min']","['Femoral artery flow-mediated dilation (FMD), resting shear rate and resting blood flow', 'resting shear rate and blood flow', 'Mean resting femoral shear rate', 'mean resting blood flow', 'femoral artery FMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}]",13.0,0.0869943,"There were no differences between conditions in the temporal change in femoral artery FMD across 3.5h (Ptime x condition > 0.05 for all).
","[{'ForeName': 'Frances C', 'Initials': 'FC', 'LastName': 'Taylor', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Fletcher', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melanie K', 'Initials': 'MK', 'LastName': 'Townsend', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn N', 'Initials': 'RN', 'LastName': 'Larsen', 'Affiliation': 'School of Agriculture and Food, The University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kym', 'Initials': 'K', 'LastName': 'Rickards', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nirav', 'Initials': 'N', 'LastName': 'Maniar', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ.'}, {'ForeName': 'Paddy C', 'Initials': 'PC', 'LastName': 'Dempsey', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anju E', 'Initials': 'AE', 'LastName': 'Joham', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Neale', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Moran', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sports Science), The University of Western Australia, Perth, Western Australia, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002513']
2618,32925495,A Low-Calorie Diet with or without Exercise Reduces Postprandial Aortic Waveform in Females with Obesity.,"PURPOSE


Arterial stiffness is considered a predictor of cardiovascular disease (CVD). Females have higher values of arterial stiffness than males, suggesting a greater risk of heart-related complications. While a low-calorie diet (LCD) reduces fasting arterial stiffness, in part through weight loss, it is unknown if interval exercise (INT) adds to the benefit of LCD on fasting and post-prandial arterial stiffness in females with obesity.
METHODS


Twenty-five females (47±2.6 yrs; 37.6±1.3 kg·m) were randomized to 13 d of LCD (n=12; mixed meals of ~1200 kcal/d) or LCD+INT (n=13; 60 min/d of supervised 3 min intervals at 90% HRpeak and 50% HRpeak). Arterial stiffness (augmentation index (AIx) and carotid-femoral pulse wave velocity (cfPWV)) and blood biochemistries were measured during a 75 g oral glucose tolerance test before and after the intervention to determine fasting and post-prandial arterial stiffness as well as insulin sensitivity (SIIS) and inflammation (CRP, IL-8, TNF-α).
RESULTS


While LCD+INT increased VO2peak and HDL compared to LCD (P=0.04 and P<0.01, respectively), both interventions decreased body fat, LDL, total cholesterol and triglycerides (all P<0.01) and increased SIIS (P=0.03). Despite no effect on fasting AIx (P=0.27), LCD and LCD+INT decreased AIx60min (-7.4±4.3 vs -7.0±5.0%, P=0.04) and tAUC120min (-663±263 vs -457±406, P=0.03). There were no changes in fasting cfPWV (P=0.91) or cfPWV120min (P=0.62). Increased SIIS and decreased IL-8 were associated with reduced fasting AIx (r=-0.44, P=0.03 and r=0.40, P=0.055) whereas decreased CRP correlated with reduced post-prandial AIx (r=0.43, P=0.04).
CONCLUSION


Independent of exercise, 13 d of LCD reduces post-prandial AIx in females with obesity. Insulin sensitivity and inflammation correlated with improved arterial stiffness, suggesting unique mechanisms regulate fasted versus post-prandial arterial stiffness.",2020,"RESULTS


While LCD+INT increased VO2peak and HDL compared to LCD (P=0.04 and P<0.01, respectively), both interventions decreased body fat, LDL, total cholesterol and triglycerides (all P<0.01) and increased SIIS (P=0.03).","['Females with Obesity', 'females with obesity', 'Twenty-five females (47±2.6 yrs; 37.6±1.3 kg·m']","['LCD+INT', 'LCD', 'Low-Calorie Diet with or without Exercise', 'low-calorie diet (LCD']","['body fat, LDL, total cholesterol and triglycerides (all P<0.01) and increased SIIS', 'CRP', 'VO2peak and HDL', 'fasting AIx', 'tAUC120min', 'Increased SIIS and decreased IL-8', 'Arterial stiffness (augmentation index (AIx) and carotid-femoral pulse wave velocity (cfPWV)) and blood biochemistries', 'reduced fasting AIx', 'arterial stiffness', 'Postprandial Aortic Waveform', 'insulin sensitivity (SIIS) and inflammation (CRP, IL-8, TNF-α', 'Insulin sensitivity and inflammation', 'LCD and LCD+INT decreased AIx60min', 'fasting cfPWV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.026757,"RESULTS


While LCD+INT increased VO2peak and HDL compared to LCD (P=0.04 and P<0.01, respectively), both interventions decreased body fat, LDL, total cholesterol and triglycerides (all P<0.01) and increased SIIS (P=0.03).","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Natalie Zm', 'Initials': 'NZ', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002515']
2619,32925516,"Impact of Video Education on Patient Knowledge, Anxiety, and Satisfaction in Selective Laser Trabeculoplasty: A Pilot Study.","PRéCIS:: In patients undergoing selective laser trabeculoplasty, preoperative video education did not improve patient knowledge regarding the procedure, decrease anxiety, or increase satisfaction, as these metrics were already favorable across all patients in this study.
PURPOSE


To assess the effect of an educational video on patient knowledge, anxiety, and satisfaction at a selective laser trabeculoplasty (SLT) procedure visit.
PATIENTS AND METHODS


Prospective, randomized trial. Patients at a single academic medical center completed a survey at their procedure visit for SLT; patients were randomized to view an educational video or no video prior to survey administration. Knowledge was assessed with a 10-item questionnaire. The 6-item State-Trait Anxiety Inventory scale (STAI-6) assessed anxiety (score >40 defined significant anxiety). Perceptions of visit quality were assessed using a Likert scale.
RESULTS


Twenty-two patients were randomized into video (n=11) and control (n=11) groups. No difference in knowledge was observed between groups (83.6% control vs. 82.7% video group, P=0.635). No patient had significant anxiety (STAI-6 range 20-40, average 29) and scores were similar between groups (P=0.385). Overall, patients had positive perceptions of visit quality, and there was no significant difference between groups (P=0.999).
CONCLUSION


Patients undergoing SLT had high levels of knowledge, low levels of anxiety, and high levels of satisfaction. In our clinical setting, an educational video seemed to have no additional benefit on these metrics and thus, may be omitted. Further research may be directed towards optimizing patient education regarding SLT, particularly in settings with poor health literacy, limited resources, or limited access to glaucoma specialists.",2020,"No difference in knowledge was observed between groups (83.6% control vs. 82.7% video group, P=0.635).","['Patients at a single academic medical center completed a survey at their procedure visit for SLT; patients', 'patients undergoing', 'Twenty-two patients were randomized into video (n=11) and control (n=11) groups']","['selective laser trabeculoplasty (SLT) procedure visit', 'educational video', 'Selective Laser Trabeculoplasty', 'Video Education', 'educational video or no video prior to survey administration', 'selective laser trabeculoplasty, preoperative video education']","['knowledge', 'high levels of knowledge, low levels of anxiety, and high levels of satisfaction', '6-item State-Trait Anxiety Inventory scale (STAI-6) assessed anxiety', 'patient knowledge, anxiety, and satisfaction', 'Patient Knowledge, Anxiety, and Satisfaction', 'Perceptions of visit quality', 'positive perceptions of visit quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",22.0,0.0668629,"No difference in knowledge was observed between groups (83.6% control vs. 82.7% video group, P=0.635).","[{'ForeName': 'Cason B', 'Initials': 'CB', 'LastName': 'Robbins', 'Affiliation': 'Duke University School of Medicine, Durham, USA.'}, {'ForeName': 'C Ellis', 'Initials': 'CE', 'LastName': 'Wisely', 'Affiliation': 'Duke Eye Center, Duke University, Durham, USA.'}, {'ForeName': 'Jullia A', 'Initials': 'JA', 'LastName': 'Rosdahl', 'Affiliation': 'Duke Eye Center, Duke University, Durham, USA.'}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Duke Eye Center, Duke University, Durham, USA.'}, {'ForeName': 'Divakar', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Duke Eye Center, Duke University, Durham, USA.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001657']
2620,32925568,Routine Bedside Use of Obstetric Early Warning System in the Postnatal Ward to Identify Maternal Morbidity Among High-Risk Women.,"OBJECTIVE


Several authorities have recommended the use of an obstetric early warning system (OEWS) to prevent severe morbidity and mortality. Data on the accuracy of OEWS in different clinical settings and maternal populations are still scarce. Our aim was to validate OEWS to detect maternal morbidity among high-risk women in the postnatal ward.
METHODS


An OEWS was assigned to women with a body mass index >35 kg/m, postpartum hemorrhage (PPH) >1500 mL, preeclampsia, concern over the maternal condition, chorioamnionitis, or type 1 diabetes. Morbidity was defined as worsening preeclampsia, action on hemorrhage, thromboembolia, diabetic ketoacidosis, puerperal infections, transfer to the intensive care unit, cardiopulmonary dysfunction, or death during the stay in the postnatal ward. The use of OEWS was implemented on November 1, 2016, and the study period ended on April 30, 2018.
RESULTS


The study group included 827 women. The incidence of maternal morbidity was 29%. Women with PPH (odds ratio [OR], 6.4 [95% confidence interval, 3.5-11.6]) and preeclampsia (OR, 5.7 [3.5-9.6]) had the highest risk for morbidity. The sensitivity of OEWS for any morbidity was 42% (35%-48%), the specificity was 83% (80%-86%), the positive predictive value was 50% (44%-56%), and the negative predictive value was 78% (76%-80%). Systolic (OR, 6.8 [4.0-11.5]) and diastolic (OR, 3.3 [1.8-6.0]) blood pressure as well as pulse (OR, 2.1 [1.1-4.2]) predicted morbidity the most.
CONCLUSIONS


In high-risk women, OEWS revealed one-half of the morbidity. Women with PPH and preeclampsia benefited most from it. Abnormal blood pressure and pulse had the strongest associations with morbidity.",2020,"The sensitivity of OEWS for any morbidity was 42% (35%-48%), the specificity was 83% (80%-86%), the positive predictive value was 50% (44%-56%), and the negative predictive value was 78% (76%-80%).","['high-risk women in the postnatal ward', '827 women', 'High-Risk Women', 'women with a body mass index >35 kg/m, postpartum hemorrhage (PPH) ', 'Women with PPH and preeclampsia']",['OEWS'],"['blood pressure as well as pulse ', 'worsening preeclampsia, action on hemorrhage, thromboembolia, diabetic ketoacidosis, puerperal infections, transfer to the intensive care unit, cardiopulmonary dysfunction, or death', 'negative predictive value', 'Morbidity', 'Abnormal blood pressure', 'highest risk for morbidity', 'Maternal Morbidity', 'specificity', 'sensitivity of OEWS for any morbidity', 'Systolic', 'preeclampsia', 'positive predictive value', 'maternal morbidity']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0034041', 'cui_str': 'Puerperal infection'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0005826', 'cui_str': 'Abnormal blood pressure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",827.0,0.102668,"The sensitivity of OEWS for any morbidity was 42% (35%-48%), the specificity was 83% (80%-86%), the positive predictive value was 50% (44%-56%), and the negative predictive value was 78% (76%-80%).","[{'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Hoppu', 'Affiliation': 'From the Department of Emergency, Anaesthesia and Pain Medicine, Tampere University Hospital.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Hannola', 'Affiliation': 'Department of Obstetrics and Gynecology, Tampere University Hospital.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Mennander', 'Affiliation': 'From the Department of Emergency, Anaesthesia and Pain Medicine, Tampere University Hospital.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rissanen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University.'}, {'ForeName': 'Eveliina', 'Initials': 'E', 'LastName': 'Tulensalo', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University.'}, {'ForeName': 'Hannele', 'Initials': 'H', 'LastName': 'Laivuori', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Tihtonen', 'Affiliation': 'Department of Obstetrics and Gynecology, Tampere University Hospital.'}]",Journal of patient safety,['10.1097/PTS.0000000000000766']
2621,32925571,Healing Our Own: A Randomized Trial to Assess Benefits of Peer Support.,"OBJECTIVES


This study aimed to develop and evaluate a structured peer support program to address the needs of providers involved in obstetric adverse outcomes.
METHODS


In this pilot randomized controlled trial, participants were providers who experienced an obstetric-related adverse outcome. Providers were randomly assigned to routine support (no further follow-up) or enhanced support (follow-up with a trained peer supporter). Participants completed surveys at baseline, 3 months, and 6 months. The primary outcome was the use of resources and the perception of their helpfulness. Secondary outcomes were the effect on the recovery stages and the duration of use of peer support.
RESULTS


Fifty participants were enrolled and randomly assigned 1:1 to each group; 42 completed the program (enhanced, 23; routine, 19). The 2 groups were not significantly different with respect to event type, demographics, or baseline stage; in both groups, most participants started at the stage 6 thriving path. Most participants required less than 3 months of support: 65.2% did not need follow-up after the first contact, and 91.3% did not need follow-up after the second contact. Participants who transitioned from an early stage of recovery (stages 1-3) to the stage 6 thriving path reported that they most often sought support from peers (P = 0.02) and departmental leadership (P = 0.07). Those in the enhanced support group were significantly more likely to consider departmental leadership as one of the most helpful resources (P = 0.02).
CONCLUSIONS


For supporting health care providers involved in adverse outcomes, structured peer support is a practicable intervention that can be initiated with limited resources.",2020,"The 2 groups were not significantly different with respect to event type, demographics, or baseline stage; in both groups, most participants started at the stage 6 thriving path.","['Fifty participants', 'Participants who transitioned from an early stage of recovery (stages 1-3', 'participants were providers who experienced an obstetric-related adverse outcome', 'Healing Our Own']","['structured peer support program', 'routine support (no further follow-up) or enhanced support (follow-up with a trained peer supporter', 'Peer Support']","['adverse outcomes', 'recovery stages and the duration of use of peer support', 'use of resources and the perception of their helpfulness']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",50.0,0.148621,"The 2 groups were not significantly different with respect to event type, demographics, or baseline stage; in both groups, most participants started at the stage 6 thriving path.","[{'ForeName': 'Enid Y', 'Initials': 'EY', 'LastName': 'Rivera-Chiauzzi', 'Affiliation': ""From the Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': ""From the Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Moore-Murray', 'Affiliation': ""From the Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': ""From the Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Goffman', 'Affiliation': ""From the Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Bernstein', 'Affiliation': ""From the Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Chazotte', 'Affiliation': ""From the Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.""}]",Journal of patient safety,['10.1097/PTS.0000000000000771']
2622,32925593,Neural effects of placebo analgesia in fibromyalgia patients and healthy individuals.,"Placebo analgesia is hypothesized to involve top-down engagement of prefrontal regions that access endogenous pain inhibiting opioid pathways. Fibromyalgia (FM) patients have neuroanatomical and neurochemical alterations in pathways relevant to placebo analgesia. Thus, it remains unclear whether placebo analgesic mechanisms would differ in FM patients compared to healthy controls (HCs). Here, using placebo-analgesia-inducing paradigms that included verbal suggestions and conditioning manipulations, we examined whether behavioral and neural placebo analgesic responses differed between 32 FM patients and 46 age- and sex-matched HCs. Participants underwent a manipulation scan, where noxious high and low heat were paired with the control and placebo cream, respectively, and a placebo experimental scan with equal noxious heat temperatures. Before the experimental scan, each participant received saline or naloxone, an opioid receptor antagonist. Across all participants, the placebo condition decreased pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the Neurologic Pain Signature. There were no differences between HCs and FM patients in pain intensity ratings or neural responses during the placebo condition. Despite the perceptual and neural effects of the placebo manipulation, prefrontal circuitry was not activated during the expectation period and the placebo analgesia was unaltered by naloxone, suggesting placebo effects were driven more by conditioning than expectation. Together, these findings suggest that placebo analgesia can occur in both HCs and chronic pain FM patients, without the involvement of opiodergic prefrontal modulatory networks.",2020,"Across all participants, the placebo condition decreased pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the Neurologic Pain Signature.","['32 FM patients and 46 age- and sex-matched HCs', 'fibromyalgia patients and healthy individuals']","['manipulation scan, where noxious high and low heat were paired with the control and placebo cream', 'saline or naloxone, an opioid receptor antagonist', 'placebo experimental scan with equal noxious heat temperatures', 'Placebo analgesia', 'placebo', 'placebo analgesia']","['pain intensity ratings or neural responses', 'pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the Neurologic Pain Signature']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3496176', 'cui_str': 'Secondary Sensory Cortex'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",,0.333537,"Across all participants, the placebo condition decreased pain intensity and unpleasantness ratings, decreased activity within the right insula and bilateral secondary somatosensory cortex, and modulated the Neurologic Pain Signature.","[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangos', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ceko', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Binquan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Richards', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Gracely', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Schweinhardt', 'Affiliation': 'The Alan Edwards Centre for Research on Pain, Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Bushnell', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}]",Pain,['10.1097/j.pain.0000000000002064']
2623,32925621,Mifepristone Combination Therapy Compared With Misoprostol Monotherapy for the Management of Miscarriage: A Cost-Effectiveness Analysis.,"OBJECTIVE


To assess whether mifepristone pretreatment adversely affects the cost of medical management of miscarriage.
METHODS


Decision tree analyses were constructed, and Monte Carlo simulations were run comparing costs of combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone) for medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management. Rates of completed medical evacuation for each were obtained from a recent randomized controlled trial.
RESULTS


In every scenario, combination therapy offered a significant cost advantage over monotherapy. Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage. The cost savings associated with combination therapy were greatest in scenarios using a staged approach to misoprostol administration and in scenarios using in-operating room dilation and curettage as the only modality for uterine evacuation, a savings of $190.20 (99% CI 189.35-191.07) and $217.85 (99% CI 217.19-218.50) per patient in a low-income wage group, respectively. A smaller difference was seen in scenarios using in-office manual vacuum aspiration to complete medical management failures. As patients' wages increased, the difference in cost between combination therapy and monotherapy increased.
CONCLUSION


Mifepristone combined with misoprostol is, overall, more cost effective than monotherapy, and therefore cost should not be a deterrent to its adoption in the management of miscarriage.",2020,"Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage.","['medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management', 'Miscarriage']","['Mifepristone Combination Therapy', 'Mifepristone', 'mifepristone', 'misoprostol', 'Misoprostol Monotherapy', 'combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone']","['cost savings', 'cost of medical management of miscarriage']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.0798285,"Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage.","[{'ForeName': 'Holly H', 'Initials': 'HH', 'LastName': 'Berkley', 'Affiliation': 'Department of Obstetrics & Gynecology at Naval Medical Center San Diego, San Diego, California; and the Uniformed Services University, Bethesda, Maryland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wittenberger', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004063']
2624,32925623,Factors Associated With Serum Estradiol Levels Among Postmenopausal Women Using Hormone Therapy.,"OBJECTIVE


To identify factors associated with serum estradiol (E2) levels among healthy postmenopausal women using hormone therapy (HT).
METHODS


This is an unplanned post hoc analysis of data from ELITE (Early versus Late Intervention Trial with Estradiol), a randomized controlled trial of 1 mg oral E2 with or without vaginal progesterone in healthy early compared with late (<6 years compared with 10 or more years since menopause) postmenopausal women. We included results from visits when women reported at least 80% compliance with HT. Mixed-effects linear models identified factors associated with serum E2 levels while participants were taking HT, assessed every 6 months over a median follow-up of 4.8 years and adjusted for baseline E2 level, visit, and reduced E2 dose. Possible correlates evaluated included demographics, clinical characteristics, medication use, and biomarkers of liver and kidney metabolic function.
RESULTS


The analysis included 2,160 E2 measurements in 275 postmenopausal women. Mean±SD age was 55.4±3.9 vs 64.4±5.5 years, and mean±SD time since menopause was 3.6±1.8 vs 16.0±5.6 years for early vs late postmenopausal women. Adjusted for pretreatment E2 level, visit, and reduced dose indicator, higher serum E2 levels were associated with higher body mass index (BMI), higher weight, surgical menopause, alcohol use, and antihypertensive medication use. Current and past smoking and antifungal medication use were associated with lower serum E2 levels. In the multivariable model, higher BMI and alcohol use were associated with higher serum E2 levels, whereas current and past smoking were associated with lower serum E2 levels. These factors were similar between early and late postmenopausal women.
CONCLUSION


Factors associated with serum E2 levels among postmenopausal women taking HT include BMI, alcohol use, and smoking. As serum E2 levels relate to HT effect, achievement of desirable E2 levels may be maximized through personalized intervention.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT00114517.",2020,Current and past smoking and antifungal medication use were associated with lower serum E2 levels.,"['Postmenopausal Women', 'healthy postmenopausal women using hormone therapy (HT', 'healthy early compared with late (<6 years compared with 10 or more years since menopause) postmenopausal women', '275 postmenopausal women', 'Mean±SD age was 55.4±3.9 vs 64.4±5.5 years, and mean±SD time since menopause was 3.6±1.8 vs 16.0±5.6 years for early vs late postmenopausal women']","['oral E2 with or without vaginal progesterone', 'Estradiol']","['body mass index (BMI), higher weight, surgical menopause, alcohol use, and antihypertensive medication use', 'Serum Estradiol Levels', 'serum E2 levels', 'demographics, clinical characteristics, medication use, and biomarkers of liver and kidney metabolic function', 'serum estradiol (E2) levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0740421', 'cui_str': 'Postsurgical menopause'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",275.0,0.0428492,Current and past smoking and antifungal medication use were associated with lower serum E2 levels.,"[{'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Thailand; and the Department of Preventive Medicine, the Department of Medicine, the Atherosclerosis Research Unit, and the Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kono', 'Affiliation': ''}, {'ForeName': 'Roksana', 'Initials': 'R', 'LastName': 'Karim', 'Affiliation': ''}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': ''}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shoupe', 'Affiliation': ''}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004006']
2625,32925651,Safety and Efficacy of Nepafenac Punctal Plug Delivery System in Controlling Postoperative Ocular Pain and Inflammation following Cataract Surgery.,"PURPOSE


To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) following cataract surgery.
SETTING


Three U.S. clinical sites DESIGN:: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study.
METHODS


Fifty-six subjects (age>22 years) with expected post-cataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n=38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n=18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively.
RESULTS


The N-PPDS group had a significantly higher percentage of pain-free patients than the p-PPDS group (69% (22/32) vs 38% (6/16) at Day 3; p=0.038 & 67% (24/36) vs 31% (5/16) at Day 7; p=0.018). A higher percentage of patients in the N-PPDS group (52% (15/29) vs 0% (0/14) (p-PPDS)) was pain free at all visits (p=0.001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells 50% (18/36) vs 19% (3/16) in p-PPDS; p=0.034) at Day 7. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and 0 in the p-PPDS group.
CONCLUSION


The N-PPDS was safe and effective for the management of ocular pain and inflammation following cataract surgery.",2020,The N-PPDS group had a significantly higher percentage of pain-free patients than the p-PPDS group (69% (22/32) vs 38% (6/16) at Day 3; p=0.038 & 67% (24/36) vs 31% (5/16) at Day 7; p=0.018).,"['Cataract Surgery', 'n=18 eyes', 'Fifty-six subjects (age>22 years) with expected post-cataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the']","['nepafenac (N-PPDS', 'nepafenac punctal plug delivery system (N-PPDS', 'placebo', 'routine unilateral cataract surgery with intraocular lens implantation', 'Nepafenac Punctal Plug Delivery System', 'placebo punctal plug delivery system (p-PPDS group']","['Anterior chamber cell scores', 'safety and efficacy', 'postoperative ocular pain and inflammation, respectively', 'percentage of pain', 'plug retention rate', 'pain free']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C1533108', 'cui_str': 'Punctal plug'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0182324', 'cui_str': 'Plug'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}]",,0.0394924,The N-PPDS group had a significantly higher percentage of pain-free patients than the p-PPDS group (69% (22/32) vs 38% (6/16) at Day 3; p=0.038 & 67% (24/36) vs 31% (5/16) at Day 7; p=0.018).,"[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Donnenfeld', 'Affiliation': 'Department of Ophthalmology, New York University, New York, NY.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Holland', 'Affiliation': 'Cincinnati Eye Institute, Edgewood, KY.'}, {'ForeName': 'Kerry D', 'Initials': 'KD', 'LastName': 'Solomon', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mt. Pleasant, SC.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000414']
2626,32925679,Radiation Exposure in Minimally Invasive Lumbar Fusion Surgery: A Randomized Controlled Trial Comparing Conventional Fluoroscopy and 3D Fluoroscopy-based Navigation.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


The aim of this study was to compare the dosemetrically determined radiation exposure of surgeon and patient during minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) using conventional 2D fluoroscopy (FLUORO) or 3D fluoroscopy-based navigation (NAV).
SUMMARY OF BACKGROUND DATA


MIS TLIF was shown to exhibit higher radiation exposures compared to open techniques. In particular, the routinely exposed surgeon encounters the risks of increased radiation doses. With the additional use of intraoperative 3D navigation, major steps of the operation can be performed without exposing the operating room staff to ionizing radiation.
METHODS


Forty-four patients undergoing monosegmental MIS TLIF were randomized into the two intraoperative imaging technique groups (FLUORO or NAV). The primary endpoint was the radiation exposure of the surgeon; the secondary endpoints were the radiation exposure of the patient and C-arm readings.
RESULTS


After exclusion of three patients, 41 patients were analyzed. In general, the average radiation exposure of the surgeon was lower in the NAV group without being statistically significant. The radiation exposure of the patient was significantly higher in the NAV group at all dosemeter sites. The average fluoroscopy time was 63 ± 36 versus 109 ± 31 sec (FLUORO versus NAV group, P < 0.001).
CONCLUSION


The additional use of intraoperative 3D fluoroscopy-based navigation compared to conventional 2D fluoroscopy alone showed a nonsignificant reduction of the radiation exposure of the surgeon in monosegmental MIS TLIF, while increasing the radiation exposure of the patient.
LEVEL OF EVIDENCE


1.",2020,"With the additional use of intraoperative 3D navigation, major steps of the operation can be performed without exposing the operating room staff to ionizing radiation.
","['Forty-four patients undergoing monosegmental MIS TLIF', 'Minimally Invasive Lumbar Fusion Surgery']","['Conventional Fluoroscopy and 3D Fluoroscopy-based Navigation', 'conventional 2D fluoroscopy (FLUORO) or 3D fluoroscopy-based navigation (NAV', 'intraoperative imaging technique groups (FLUORO or NAV', 'intraoperative 3D fluoroscopy-based navigation compared to conventional 2D fluoroscopy alone', 'Radiation Exposure', 'surgeon and patient during minimally invasive transforaminal lumbar interbody fusion (MIS TLIF']","['average fluoroscopy time', 'average radiation exposure of the surgeon', 'radiation exposure of the surgeon; the secondary endpoints were the radiation exposure of the patient and C-arm readings']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",44.0,0.0527076,"With the additional use of intraoperative 3D navigation, major steps of the operation can be performed without exposing the operating room staff to ionizing radiation.
","[{'ForeName': 'Jan-Helge', 'Initials': 'JH', 'LastName': 'Klingler', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Scholz', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Krüger', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Yashar', 'Initials': 'Y', 'LastName': 'Naseri', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Volz', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hohenhaus', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brönner', 'Affiliation': 'Helmholtz Zentrum München, German Research Center for Environmental Health, Individual Monitoring Service, Munich, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Hoedlmoser', 'Affiliation': 'Helmholtz Zentrum München, German Research Center for Environmental Health, Individual Monitoring Service, Munich, Germany.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Sircar', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hubbe', 'Affiliation': 'Department of Neurosurgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}]",Spine,['10.1097/BRS.0000000000003685']
2627,32925713,Research based on the core pathogenesis in the treatment according to traditional Chinese medicine syndrome differentiation for heart failure with normal ejection fraction.,"BACKGROUND


The incidence of heart failure with normal ejection fraction (HFNEF) is increasing yearly, accounting for approximately half of all heart failure cases. Even after standardized treatment, the patient's prognosis is not good. Therefore, it is necessary to explore new treatment methods for HFNEF. Yangyin Shuxin Decoction, a traditional Chinese medicine prescription from our clinical experience in the treatment of HFNEF, has a potential cardioprotective effect. Preliminary clinical trials have shown that this prescription can improve the quality of life of HFNEF. This prompted us to use more objective indicators to further evaluate whether Yangyin Shuxin Decoction can improve the exercise capacity in HENEF patients.
METHODS


This is a single-center parallel randomized controlled trial. The 64 patients who met the inclusion criteria were from the Cardiovascular Clinic. They will be randomly assigned to the treatment group (Yangying Shuxin Decoction combined with standard treatment) or the control group (standard treatment) according to the ratio of 1:1. The course of treatment will be 2 weeks. Both groups were interviewed at the following time points: of at enrollment (V1), and week 2 (V2), week 4 (V3), week 8 (V4), and week 12 (V5) after enrollment. The primary indicator is the peak oxygen consumption (Peak VO2) of the cardiopulmonary exercise test (CPET). Secondary indicators include CPET indicators such as anaerobic threshold oxygen consumption, carbon dioxide ventilation equivalent slope, echocardiographic indicators such as the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e'), left atrial volume index (LAVI), left ventricular mass index (LVMI), the peak velocity of tricuspid regurgitation (TR), B-type natriuretic peptide (BNP), New York Heart Association (NYHA) cardiac function grading, and so on. These indicators will be used to evaluate the effect of Yangyin Shuxin Decoction on exercise capacity in patients with HFNEF.
DISCUSSION


At present, it is unclear whether the exercise capacity can be maintained after long-term use of Yangyin Shuxin Decoction. In this study, we will evaluate whether Yangyin Shuxin Decoction can improve the exercise capacity and quality of life of patients with HFNEF. This will provide an objective basis for the therapeutic effect of traditional Chinese medicine on HFNEF.
TRIAL REGISTRATION


This study protocol has been listed in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-17014206, http://www.chictr.org.cn/showproj.aspx?proj=24304) on December 28, 2017.",2020,"Yangyin Shuxin Decoction, a traditional Chinese medicine prescription from our clinical experience in the treatment of HFNEF, has a potential cardioprotective effect.","['HENEF patients', '64 patients who met the inclusion criteria were from the Cardiovascular Clinic', 'patients with HFNEF']","['Shuxin Decoction combined with standard treatment', 'Yangyin Shuxin Decoction']","[""CPET indicators such as anaerobic threshold oxygen consumption, carbon dioxide ventilation equivalent slope, echocardiographic indicators such as the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e'), left atrial volume index (LAVI), left ventricular mass index (LVMI), the peak velocity of tricuspid regurgitation (TR), B-type natriuretic peptide (BNP), New York Heart Association (NYHA) cardiac function grading, and so on"", 'quality of life of HFNEF', 'exercise capacity', 'peak oxygen consumption (Peak VO2) of the cardiopulmonary exercise test (CPET', 'exercise capacity and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451631', 'cui_str': 'Cardiovascular clinic'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0428784', 'cui_str': 'Peak velocity of tricuspid regurgitation'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}]",,0.0650982,"Yangyin Shuxin Decoction, a traditional Chinese medicine prescription from our clinical experience in the treatment of HFNEF, has a potential cardioprotective effect.","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021663']
2628,32925729,Femoral nerve block versus obturator nerve block for pain management after total knee replacement: A randomized controlled trial protocol.,"BACKGROUND


Several studies reported short-term analgesic efficacy of obturator nerve block (ONB), as in comparison with the femoral nerve block (FNB) in the treatment of postoperative pain after the total knee replacement (TKR). The optimal method remains under debate. The purpose of our current work is to compare the safety and efficacy of FNB and ONB for postoperative analgesia after TKR.
METHODS


This prospective, randomized, and controlled study was performed from January 2018 to December 2019. It was authorized via the Institutional Review Committee in NO.971 Hospital of the People's Liberation Army Navy (2019-PLAN-132).Two hundred patients were divided randomly into 2 groups, the control group (n = 100) and study group (n = 100). The experimental group received FNB and control groups received ONB. Primary outcome included pain at different time point (Visual Analogue Scale score of anterior knee pain at rest and in motion). The Visual Analogue Scale scores were marked by patients themselves on a paper with a graduated line starting at 0 (no pain) and ending at 10 (the most painful). Opioid consumption was converted to equivalents of oral morphine uniformly for statistical analysis. Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.
RESULTS


Table 1 will show the clinical outcomes between the 2 groups.
CONCLUSION


This trial would provide an evidence for the use of different types of peripheral nerve blocks in TKR.",2020,"Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.
","[""NO.971 Hospital of the People's Liberation Army Navy (2019-PLAN-132).Two hundred patients"", 'January 2018 to December 2019', 'pain management after total knee replacement']","['FNB and control groups received ONB', 'obturator nerve block (ONB', 'FNB and ONB', 'Femoral nerve block versus obturator nerve block']","['Opioid consumption', 'knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis', 'pain at different time point (Visual Analogue Scale score of anterior knee pain at rest and in motion', 'Visual Analogue Scale scores']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394741', 'cui_str': 'Local anesthetic obturator nerve block'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",,0.0884248,"Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, NO.971 Hospital of the People's Liberation Army Navy, Shangdong, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Fuheng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021956']
2629,32931684,Brief Report: Using Behavioral Economics to Increase HIV Knowledge and Testing Among Latinx Sexual Minority Men and Transgender Women: A Quasi-Experimental Pilot Study.,"OBJECTIVE


To determine how weekly text messages and small incentives impact HIV knowledge and frequency of HIV testing among Latinx sexual minority men (LSMM) and transgender women (LTGW).
DESIGN


Prospectively randomized participants into 2 intervention arms compared with a nonrandomized comparison group.
SETTING


Bienestar, a primarily Latinx focused HIV service provider located across Los Angeles County.
SUBJECTS, PARTICIPANTS


Two hundred eighteen participants self-identifying as LSMM or LTGW, HIV negative, having regular mobile phone access, ≥18 years, and fluent in English or Spanish.
INTERVENTION


The ""information only"" (IO) group received text messages with HIV prevention information. The ""information plus"" (IP) group additionally could win incentives by answering weekly quiz questions correctly and testing for HIV once every 3 months. We followed participants for 12 months.
MAIN OUTCOME MEASURE(S)


HIV knowledge and frequency of HIV testing.
RESULTS


We found no effect on HIV knowledge in the IO group but a statistically significant improvement in the IP group (79.2%-88.1%; P = 0.007). The frequency of HIV testing was higher in both intervention groups relative to the comparison group: On average, 22.0% of IO participants and 24.9% of IP participants tested at a Bienestar site within a given 3-month period, compared with 13.0% in the comparison group. This represents unadjusted relative risk ratios of 1.69 for the IO group (95% CI: 1.25 to 2.1; P < 0.01) and 1.91 for the IP group (95% CI: 1.51 to 2.31; P < 0.01), respectively.
CONCLUSIONS


This study demonstrates that a simple, low-cost intervention may help increase HIV testing frequency among LSMM and LTGW, 2 groups at high HIV risk.",2020,"The frequency of HIV testing was higher in both intervention groups relative to the comparison group: On average, 22.0% of IO participants and 24.9% of IP participants tested at a Bienestar site within a given 3-month period, compared with 13.0% in the comparison group.","['Latinx sexual minority men (LSMM) and transgender women (LTGW', 'Latinx Sexual Minority Men and Transgender Women', 'Two hundred eighteen participants self-identifying as LSMM or LTGW, HIV negative, having regular mobile phone access, ≥18 years, and fluent in English or Spanish', 'Bienestar, a primarily Latinx focused HIV service provider located across Los Angeles County']",['Behavioral Economics'],"['frequency of HIV testing', 'HIV knowledge and frequency of HIV testing', 'HIV knowledge', 'relative risk ratios']","[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",218.0,0.05884,"The frequency of HIV testing was higher in both intervention groups relative to the comparison group: On average, 22.0% of IO participants and 24.9% of IP participants tested at a Bienestar site within a given 3-month period, compared with 13.0% in the comparison group.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacCarthy', 'Affiliation': 'aRAND Corporation, Behavioral and Policy Sciences, Santa Monica, CA; bRAND Corporation, Economics, Sociology, and Statistics, Santa Monica, CA; cBienestar Human Services, Inc., Los Angeles, CA; dCalifornia State University, Long Beach, School of Social Work, Long Beach, CA; eRAND Corporation, Pardee RAND Graduate School, Santa Monica, CA; and fDivision of Gender, Health and Sexuality, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University, New York, NY.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Barreras', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Menodza-Graf', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Dieguez', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002433']
2630,32931691,Randomized Trial Comparing Preliminary Results of Radialization and Centralization Procedures in Bayne Types 3 and 4 Radial Longitudinal Deficiency.,"BACKGROUND


The choice of surgical procedure in severe (Bayne and Klug types 3 and 4) radial longitudinal deficiency (RLD) is contentious. Existing studies have reported varying results with both centralization and radialization procedures. The purpose of this study was to compare the clinical and radiologic outcome of radialization and centralization procedures at a short-to-intermediate-term follow-up for the treatment of types 3 and 4 RLD.
METHODS


Fourteen patients with 17 affected limbs having types 3 or 4 RLD were recruited in this prospective, randomized, controlled trial. After initial application of successive casts for soft tissue distraction, patients were randomized to 2 wrist alignment procedures-centralization and radialization. Clinical and radiologic parameters recorded at stipulated intervals until a final follow-up of 24 months included hand-forearm angle, ulnar bow, forearm length, arm length, total angulation, and range of motion at elbow, wrist, and fingers.
RESULTS


Centralization was performed in 9 affected limbs, whereas radialization was performed in 8 affected limbs. Nine affected limbs had type 4 RLD, and 8 affected limbs had type 3 RLD. There was no significant difference in the hand-forearm angle in the immediate postoperative period. At 3 months, the radiologic hand-forearm angle increased to 19 degrees in the centralization group, while the radialization group showed an average increase to 4 degrees. This increase in the hand-forearm angle continued at 6-, 12-, and 24-month follow-up assessments. Worsening of the deformity was more in the centralization group, as compared with the radialization group. The forearm length also significantly differed in the 2 groups at 6-, 12-, and 24-month follow-up; however, when adjusted for preoperative lengths, the difference was significant only at 12- and 24-month follow-up.
CONCLUSIONS


At a short-to-intermediate-term follow-up, radialization fares better than centralization in terms of recurrence of deformity and in terms of affecting the forearm length. Longer follow-up with a larger sample size is needed to draw definitive conclusions.
LEVEL OF EVIDENCE


Level I.",2020,"This increase in the hand-forearm angle continued at 6-, 12-, and 24-month follow-up assessments.","['Bayne Types 3 and 4 Radial Longitudinal Deficiency', 'Fourteen patients with 17 affected limbs having types 3 or 4 RLD']","['Radialization and Centralization Procedures', 'radialization and centralization procedures']","['forearm length', 'radiologic hand-forearm angle', 'Worsening of the deformity']","[{'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",14.0,0.0537198,"This increase in the hand-forearm angle continued at 6-, 12-, and 24-month follow-up assessments.","[{'ForeName': 'Samarth', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': '*Department of Orthopaedics, Jai Prakash Narayan Apex Trauma Centre (AIIMS) †Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Bhavuk', 'Initials': 'B', 'LastName': 'Garg', 'Affiliation': ''}, {'ForeName': 'Nishank', 'Initials': 'N', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Kotwal', 'Affiliation': ''}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001606']
2631,32931725,"Aerosol, vapor, or chemicals? College student perceptions of harm from electronic cigarettes and support for a tobacco-free campus policy.","OBJECTIVE


This study is the first to examine the influence of e-cigarette emission phrasing on perceived harm of secondhand exposure, and whether harm perception was associated with support for a tobacco-free campus policy.  Participants:  In the fall 2018 and spring 2019 semesters, 52 sections of a college English course (N = 791 students) were cluster randomized to one of three conditions (""vapor,"" ""aerosol,"" or ""chemicals"") assessing harm of secondhand exposure to e-cigarette emissions.  Methods:  Regression models adjusted for demographic characteristics, tobacco use, and other potential confounders.  Results:  Compared to the ""vapor"" condition, ""chemicals"" and ""aerosol"" conditions were associated with increased odds of perceiving secondhand exposure to e-cigarettes to be harmful/very harmful (AOR = 2.0,  p  < 0.01). Greater perceived harm of secondhand e-cigarette exposure was associated with increased odds of supporting a tobacco-free campus policy (AOR = 2.22,  p  < 0.001).  Conclusions:  Health campaigns should use accurate terminology to describe e-cigarette emissions, rather than jargon that conveys lower risk.",2020,"Greater perceived harm of secondhand e-cigarette exposure was associated with increased odds of supporting a tobacco-free campus policy (AOR = 2.22,  p  < 0.001).  ","['Participants', 'In the fall 2018 and spring 2019 semesters, 52 sections of a college English course (N\u2009=\u2009791 students']","['three conditions (""vapor,"" ""aerosol,"" or ""chemicals"") assessing harm of secondhand exposure to e-cigarette emissions']",['harm of secondhand e-cigarette exposure'],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0597635', 'cui_str': 'Vapor'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0233929', 'cui_str': 'Emission'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0223533,"Greater perceived harm of secondhand e-cigarette exposure was associated with increased odds of supporting a tobacco-free campus policy (AOR = 2.22,  p  < 0.001).  ","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Rossheim', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, Virginia, USA.'}, {'ForeName': 'Xiaoquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Communication, George Mason University, Fairfax, Virginia, USA.'}, {'ForeName': 'Eric K', 'Initials': 'EK', 'LastName': 'Soule', 'Affiliation': 'Department of Health Education and Promotion, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Thombs', 'Affiliation': 'School of Public Health, University of North Texas Health Science Center, Fort Worth, Texas, USA.'}, {'ForeName': 'Sumihiro', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of North Texas Health Science Center, Fort Worth, Texas, USA.'}, {'ForeName': 'Asra', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, Virginia, USA.'}, {'ForeName': 'Tracey E', 'Initials': 'TE', 'LastName': 'Barnett', 'Affiliation': 'School of Public Health, University of North Texas Health Science Center, Fort Worth, Texas, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1819293']
2632,32931742,Text Messaging to Increase Compliance with Adjuvant Endocrine Therapy in Breast Cancer.,"Many breast cancer patients do not complete long-term hormonal therapies. Text messaging emerged as a tool to enhance medication compliance, but a trial of twice-weekly text message reminders (published in the Journal of Clinical Oncology) failed to improve adherence. The results, however, pave the way for 2nd generation texting approaches.",2020,"Text messaging emerged as a tool to enhance medication compliance, but a trial of twice-weekly text message reminders (published in the Journal of Clinical Oncology) failed to improve adherence.","['Breast Cancer', 'Many breast cancer patients']",['Adjuvant Endocrine Therapy'],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]",[],,0.0232902,"Text messaging emerged as a tool to enhance medication compliance, but a trial of twice-weekly text message reminders (published in the Journal of Clinical Oncology) failed to improve adherence.","[{'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06520-8032, USA. Electronic address: lajos.pusztai@yale.edu.'}, {'ForeName': 'Reneé', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06520-8032, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Mougalian', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06520-8032, USA.'}]",Cancer cell,['10.1016/j.ccell.2020.08.006']
2633,32931763,Spinal manipulation for subacute and chronic lumbar radiculopathy: a randomized controlled trial.,"OBJECTIVE


We evaluated the efficacy of spinal manipulation for the management of non-acute lumbar radiculopathy.
METHODS


In a university hospital we performed a randomized controlled trial with two parallel arms. Patients (n=44) with unilateral radicular low back pain lasting more than 4 weeks were randomly allocated to manipulation and control groups. The primary outcome was the intensity of the low back pain on a visual analog scale. The secondary outcome was the Oswestry Disability Questionnaire score. We also measured spinal ranges of motion. The assessments were carried out at the baseline, immediately after intervention and at three months follow-up. All patients underwent physiotherapy. The manipulation group received three sessions of manipulation therapy, one week apart. For manipulation, we used Robert Maigne's technique.
RESULTS


Both groups experienced a decrease in back and leg pain significantly (all p≤0.003). However, only the manipulation group showed significantly favorable results in the Oswestry scores (p<0.001), and the straight leg raise test (p=0.001). All ranges of motion increased significantly with manipulation (all p<0.001), but the control group showed favorable results only in right and left rotations and in extension (all p<0.001). Between-group analyses showed significantly better outcomes for manipulation in all measurements (all p≤0.009) with large effect sizes.
CONCLUSION


Spinal manipulation improves the results of physiotherapy over a period of three months for patients with subacute or chronic lumbar radiculopathy.",2020,"However, only the manipulation group showed significantly favorable results in the Oswestry scores (p<0.001), and the straight leg raise test (p=0.001).","['subacute and chronic lumbar radiculopathy', 'patients with subacute or chronic lumbar radiculopathy', 'Patients (n=44) with unilateral radicular low back pain lasting more than 4 weeks']","['spinal manipulation', 'physiotherapy', 'Spinal manipulation']","['intensity of the low back pain on a visual analog scale', 'Oswestry scores', 'straight leg raise test', 'Oswestry Disability Questionnaire score', 'back and leg pain']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}]",44.0,0.0964355,"However, only the manipulation group showed significantly favorable results in the Oswestry scores (p<0.001), and the straight leg raise test (p=0.001).","[{'ForeName': 'Seyedezahra Hosseini', 'Initials': 'SH', 'LastName': 'Ghasabmahaleh', 'Affiliation': 'Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences. Electronic address: hosseini.zs@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezasoltani', 'Affiliation': 'Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences. Electronic address: z.rezasoltani@ajaums.ac.ir.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dadarkhah', 'Affiliation': 'Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences. Electronic address: a.dadarkhah@ajaums.ac.ir.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Hamidipanah', 'Affiliation': 'Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences. Electronic address: y.hamidihamidi@yahoo.com.'}, {'ForeName': 'Reza Kazempour', 'Initials': 'RK', 'LastName': 'Mofrad', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Faculty of Medicine. Electronic address: rezakazempoor@sbmu.ac.ir.'}, {'ForeName': 'Sharif', 'Initials': 'S', 'LastName': 'Najafi', 'Affiliation': 'Clinical Biomechanics and Ergonomics Research Center, Faculty of Medicine, Aja University of Medical Sciences. Electronic address: sh.najafi@ajaums.ac.ir.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.08.005']
2634,32931959,Higher adenoma detection rates at screening associated with lower long-term colorectal cancer incidence and mortality.,"BACKGROUND AND AIMS


Detection and removal of adenomas reduces colorectal cancer (CRC) risk. The impact of adenoma detection rates (ADRs) on long-term CRC incidence and mortality is unknown. We investigated this using data from the UK Flexible Sigmoidoscopy Screening Trial (UKFSST).
METHODS


Of 167,882 UKFSST participants, 40,085 were in the intervention arm and underwent flexible sigmoidoscopy screening at 13 trial centres. Median follow-up was 17 years. At each centre, one endoscopist performed most flexible sigmoidoscopies. Multivariable logistic regression was used to classify centres into high-, intermediate-, and low-detector groups based on their main endoscopist's ADR. We calculated incidence and mortality of distal and all-site CRC, and estimated hazard ratios (HRs) with 95% confidence intervals (CIs) using Cox regression.
RESULTS


Five, four, and four centres, respectively, were classified into the high-detector, intermediate-detector, and low-detector groups. Average ADRs in each respective group were 15%, 12%, and 9%. Distal CRC incidence and mortality were reduced among those screened compared to controls in all groups, and effects of screening varied significantly by detector ranking, with larger reductions in incidence and mortality seen in the high-detector (incidence: HR=0·34, 0·27-0·42; mortality: HR=0·22, 0·13-0·37) than low-detector group (incidence: HR=0·55, 0·44-0·68; mortality: HR=0·54, 0·34-0·86). Similar results were observed for all-site CRC, with larger effects seen in the high-detector (incidence: HR=0·58, 95%CI 0·50-0·67; mortality: HR=0·52, 0·39-0·69) than low-detector group (incidence: HR=0·72, 0·61-0·85; mortality: HR=0·68, 0·51-0·92), although the heterogeneity was not statistically significant.
CONCLUSIONS


Higher ADRs at screening provide greater long-term protection against CRC incidence and mortality.",2020,"Distal CRC incidence and mortality were reduced among those screened compared to controls in all groups, and effects of screening varied significantly by detector ranking, with larger reductions in incidence and mortality seen in the high-detector (incidence: HR=0·34, 0·27-0·42; mortality: HR=0·22, 0·13-0·37) than low-detector group (incidence: HR=0·55, 0·44-0·68; mortality: HR=0·54, 0·34-0·86).","['Of 167,882 UKFSST participants, 40,085 were in the intervention arm and underwent']",['flexible sigmoidoscopy screening'],"['incidence and mortality of distal and all-site CRC, and estimated hazard ratios (HRs', 'Distal CRC incidence and mortality', 'Higher adenoma detection rates', 'Average ADRs']","[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",167882.0,0.0406585,"Distal CRC incidence and mortality were reduced among those screened compared to controls in all groups, and effects of screening varied significantly by detector ranking, with larger reductions in incidence and mortality seen in the high-detector (incidence: HR=0·34, 0·27-0·42; mortality: HR=0·22, 0·13-0·37) than low-detector group (incidence: HR=0·55, 0·44-0·68; mortality: HR=0·54, 0·34-0·86).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Imperial College London, London, UK. Electronic address: amanda.cross1@imperial.ac.uk.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Robbins', 'Affiliation': 'Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Saunders', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital, London, UK.""}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wooldrage', 'Affiliation': 'Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Imperial College London, London, UK.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.09.020']
2635,32931978,"Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial.","BACKGROUND


Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.
MATERIALS AND METHODS


A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm 2  were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.
RESULTS


In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.
CONCLUSION


Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.",2020,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","['patients with a Ventral Hernia Working Group Grade 3 hernia', 'Patients aged ≥ 18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included', '84 patients were treated with Phasix™ Mesh', 'patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair', 'These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula', 'potentially contaminated incisional hernias', '15 hospitals across Europe']","['new slowly resorbable biosynthetic mesh (Phasix™', 'Phasix™ Mesh', 'new resorbable biosynthetic mesh (Phasix™']","['hernia recurrences', 'rate of resorption', 'acceptable postoperative surgical site occurrence rates', 'rate of surgical site occurrences (SSO), including infections, that required intervention until 3 months after repair', 'recurrence rate', 'quality of life', 'surgical site occurrence development', '32 surgical site occurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",84.0,0.180861,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","[{'ForeName': 'Mathilde Mj', 'Initials': 'MM', 'LastName': 'van Rooijen', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands. Electronic address: m.vanrooijen@erasmusmc.nl.'}, {'ForeName': 'An P', 'Initials': 'AP', 'LastName': 'Jairam', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Tollens', 'Affiliation': 'Imelda Hospital, Department of General Surgery, Bonheiden, Belgium.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'University of Copenhagen, Bispebjerg Hospital, Department of Surgery, Copenhagen, Denmark.'}, {'ForeName': 'Tammo S', 'Initials': 'TS', 'LastName': 'de Vries Reilingh', 'Affiliation': 'Elkerliek Hospital, Department of Surgery, Helmond, The Netherlands.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'University Hospital Lille, Department of Surgery, Lille, France.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Köckerling', 'Affiliation': 'Vivantes Klinikum Spandau, Department of Surgery, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miserez', 'Affiliation': 'University Hospital Leuven, Department of Abdominal Surgery, Leuven, Belgium.'}, {'ForeName': 'Alastair Cj', 'Initials': 'AC', 'LastName': 'Windsor', 'Affiliation': 'University College London Hospital, Department of Colorectal Surgery, London, United Kingdom.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Berrevoet', 'Affiliation': 'University Hospital Ghent, Department of General and Hepatobiliary Surgery, Ghent, Belgium.'}, {'ForeName': 'René H', 'Initials': 'RH', 'LastName': 'Fortelny', 'Affiliation': 'Wilhelminenhospital, Department of General, Visceral and Oncologic Surgery, Vienna, Austria.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dousset', 'Affiliation': 'Hôpital Cochin, Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris, France.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Woeste', 'Affiliation': 'Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt Am Main, Germany.'}, {'ForeName': 'Henderik L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Isala Zwolle, Department of Surgery, Zwolle, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Gossetti', 'Affiliation': 'Università di Roma Sapienza, Rome, Italy.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands; IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Geert Wm', 'Initials': 'GW', 'LastName': 'Tetteroo', 'Affiliation': 'IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Chirurgische Praxis Cottbus, Cottbus Area, Germany.'}, {'ForeName': 'Leonard F', 'Initials': 'LF', 'LastName': 'Kroese', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.053']
2636,32931984,The clinical effectiveness of intensive management in moderate established rheumatoid arthritis: The titrate trial.,"OBJECTIVES


Many trials have shown that intensive management is effective in patients with early active rheumatoid arthritis (RA). But its benefits are unproven for the large number of RA patients seen in routine care who have established, moderately active RA and are already taking conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). The TITRATE trial studied whether these patients also benefit from intensive management and, in particular, achieve more remissions.
METHODS


A 12-month multicentre individually randomised trial compared standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals and incorporated monthly clinical assessments, medication titration and psychosocial support. The primary outcome was 12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR). Secondary outcomes included fatigue, disability, harms and healthcare costs. Intention-to-treat multivariable logistic- and linear regression analyses compared treatment arms with multiple imputation used for missing data.
RESULTS


459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes. Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004). Intensive management also significantly increased remissions using a range of alternative remission criteria and increased patients with DAS28-ESR low disease activity scores. (48% vs 32%, p = 0.005). In addition it substantially reduced fatigue (mean difference -18; 95% CI: -24, -11, p<0.001). There was no evidence that serious adverse events (intensive management =15 vs standard care =11) or other adverse events (114 vs 151) significantly increase with intensive management.
INTERPRETATION


The trial shows that intensive management incorporating psychosocial support delivered by specially trained healthcare professions is effective in moderately active established RA. More patients achieve remissions, there were greater improvements in fatigue, and there were no more harms.",2020,"Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004).","['459 patients were screened and 335 were randomised (168 intensive management; 167 standard care); 303 (90%) patients provided 12-month outcomes', 'patients with early active rheumatoid arthritis (RA', 'moderate established rheumatoid arthritis']","['standard care with monthly intensive management appointments which was delivered by specially trained healthcare professionals', 'intensive management']","['12-month remission assessed using the Disease Activity Score for 28 joints using ESR (DAS28-ESR', 'DAS28-ESR 12-month remissions', 'adverse events', 'fatigue, disability, harms and healthcare costs', 'fatigue', 'DAS28-ESR low disease activity scores', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0151631', 'cui_str': 'Low erythrocyte sedimentation rate'}]",459.0,0.189248,"Intensive management increased DAS28-ESR 12-month remissions compared to standard care (32% vs 18%, p = 0.004).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Fowzia', 'Initials': 'F', 'LastName': 'Ibrahim', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom. Electronic address: fowzia.ibrahim@kcl.ac.uk.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'ScHARR Health Economics and Decision Science, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tom', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Cambridge Institute of Public Health, Forvie Site, Robinson Way, Cambridge Biomedical Campus, Cambridge, CB2 0SR, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Prothero', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Rhiannon R', 'Initials': 'RR', 'LastName': 'Baggott', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Bosworth', 'Affiliation': 'National Rheumatoid Arthritis Society (NRAS), Switchback Office Park, Gardner Rd, Maidenhead, SL6 7RJ, United Kingdom.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Galloway', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Georgopoulou', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Neatrour', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nikiphorou', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Sturt', 'Affiliation': ""Department Of Adult Nursing, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, James Clerk Maxwell Building, 57 Waterloo Road, London SE1 8WA, United Kingdom.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Wailoo', 'Affiliation': 'ScHARR Health Economics and Decision Science, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom.'}, {'ForeName': 'Frances Mk', 'Initials': 'FM', 'LastName': 'Williams', 'Affiliation': ""Twin Research & Genetic Epidemiology, School of Life Course Sciences, King's College London, St Thomas' Hospital, London SE1 7EH, United Kingdom.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lempp', 'Affiliation': ""Centre for Rheumatic Diseases, Department of Inflammation Biology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London Cutcombe Road, London, SE5 9RJ, United Kingdom.""}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.07.014']
2637,32931996,The use of modified Mindfulness-based Stress Reduction and Mindfulness-based Cognitive Therapy programme for family caregivers of people living with dementia: a feasibility study.,"PURPOSE


The aim of this study was to investigate the feasibility and preliminary efficacy of a modified Mindfulness-Based Stress Reduction (MBSR) programme and Mindfulness-Based Cognitive Therapy (MBCT) programme for reducing the stress, depressive symptoms, and subjective burden of family caregivers of people with dementia (PWD).
METHODS


A prospective, parallel-group, randomized controlled trial design was adopted. Fifty-seven participants were recruited from the community and randomized into either the modified MBSR group (n = 27) or modified MBCT group (n = 26), receiving seven face-to-face intervention sessions over 16 weeks. Various psychological outcomes were measured at baseline (T0), immediately post-intervention (T1), and at the 3-month follow-up (T2).
RESULTS


Both interventions were found to be feasible in view of the high attendance (over 70.0%) and low attrition (3.77%) rates. The mixed ANOVA results showed positive within-group effects on perceived stress (p = .030, Cohen's d = .54), depressive symptoms (p = .002, Cohen's d = .77), and subjective caregiver burden (p < .001, Cohen's d = 1.12) in both interventions across the time points, while the modified MBCT had a larger effect on stress reduction, compared with the modified MBSR (p = .019).
CONCLUSIONS


Both the modified MBSR and MBCT are acceptable to family caregivers of PWD. Their preliminary effects were improvements in stress, depressive symptoms, and subjective burden. The modified MBCT may be more suitable for caregivers of PWD than the MBSR. A future clinical trial is needed to confirm their effectiveness in improving the psychological well-being of caregivers of PWD.",2020,"The mixed ANOVA results showed positive within-group effects on perceived stress (p = .030, Cohen's d = .54), depressive symptoms (p = .002, Cohen's d = .77), and subjective caregiver burden (p < .001, Cohen's d = 1.12) in both interventions across the time points, while the modified MBCT had a larger effect on stress reduction, compared with the modified MBSR (p = .019).
","['family caregivers of people living with dementia', 'family caregivers of people with dementia (PWD', 'Fifty-seven participants']","['modified MBCT', 'modified Mindfulness-based Stress Reduction and Mindfulness-based Cognitive Therapy programme', 'modified MBSR', 'modified Mindfulness-Based Stress Reduction (MBSR) programme and Mindfulness-Based Cognitive Therapy (MBCT) programme']","['low attrition', 'perceived stress', 'stress, depressive symptoms, and subjective burden', 'Various psychological outcomes', 'depressive symptoms', 'subjective caregiver burden', 'stress reduction']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",57.0,0.0380911,"The mixed ANOVA results showed positive within-group effects on perceived stress (p = .030, Cohen's d = .54), depressive symptoms (p = .002, Cohen's d = .77), and subjective caregiver burden (p < .001, Cohen's d = 1.12) in both interventions across the time points, while the modified MBCT had a larger effect on stress reduction, compared with the modified MBSR (p = .019).
","[{'ForeName': 'Daphne Sze Ki', 'Initials': 'DSK', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Patrick Pui Kin', 'Initials': 'PPK', 'LastName': 'Kor', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Davies', 'Affiliation': 'Primary Care and Population Health, UCI Medical School, University College London, London, United Kingdom.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moyle', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Annie Lai King', 'Initials': 'ALK', 'LastName': 'Yip', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Chambers', 'Affiliation': 'University of Technology Sydney, Australia.'}, {'ForeName': 'Clare Tsz Kiu', 'Initials': 'CTK', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lai', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong SAR. Electronic address: claudia.lai@polyu.edu.hk.'}]",Asian nursing research,['10.1016/j.anr.2020.08.009']
2638,32932009,"The preliminary effects of henna on chemotherapy-induced peripheral neuropathy in women receiving oxaliplatin-based treatment: A parallel-group, randomized, controlled pilot trial.","PURPOSE


Chemotherapy-induced peripheral neuropathy (CIPN) may frequently occur in patients receiving oxaliplatin-based treatment. The aim of the present parallel-group, randomized, controlled pilot trial was to investigate the effect of henna on CIPN in women receiving oxaliplatin-based treatment.
METHOD


Sixty female patients receiving oxaliplatin-based treatment were randomly divided into two groups, i.e., one intervention group (n = 30) where henna was applied topically and one control group (n = 30) that received routine treatment and care. Women in the intervention group were provided a pack of henna prepared by the investigators following each treatment course (2nd, 3rd, and 4th courses) and were instructed to apply the henna on their palms, fingers, and soles. The chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT) was completed by women subsequent to the 2nd (baseline), 3rd, and 4th courses of treatment.
RESULTS


The intragroup assessment performed for the intervention group revealed that the total CIPNAT score significantly declined in the intervention group (p < 0.05). The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group × time interaction was η 2  = 0.169. Similarly, regarding the symptoms intervention section of the tool, a positive change by time in the intervention group was observed, and the effect size concerning this change was large, i.e., η 2  = 0.284.
CONCLUSIONS


The present study results showed that henna application on hands and feet has a beneficial effect on peripheral neuropathy. Applying henna is a promising approach in CIPN management.",2020,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","['women receiving oxaliplatin-based treatment', 'patients receiving oxaliplatin-based treatment', 'Sixty female patients receiving oxaliplatin-based treatment']","['henna was applied topically and one control group (n\xa0=\xa030) that received routine treatment and care', 'chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT']",['total CIPNAT score'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0064698', 'cui_str': 'lawsone'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0266703,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","[{'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Necmettin Erbakan University, Faculty of Nursing, Konya, Turkey. Electronic address: seldaarslan@erbakan.edu.tr.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Zorba Bahceli', 'Affiliation': 'Izmir Bakircay University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: pinarzorba85@gmail.com.'}, {'ForeName': 'Yeter', 'Initials': 'Y', 'LastName': 'İlik', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: yeteriner@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Artaç', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: mehmetartac@yahoo.com.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101827']
2639,32932051,Measuring upper limb disability for patients with neck pain: Evaluation of the feasibility of the single arm military press (SAMP) test.,"BACKGROUND


Non-specific neck pain (NSNP) is frequently associated with upper limb disability (ULD). Consequently, evaluation of ULD using an outcome measure is necessary during the management of patients with NSNP. The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain. During the SAMP test, patients are asked to repeatedly lift a weight above their head for 30 s. The number of repetitions is counted. Its clinical utility in a patient group is still unknown.
OBJECTIVE


This study investigates the feasibility of the SAMP test from patients and clinicians' perspectives.
METHODS


Seventy female patients with NSNP were randomly allocated into one of three groups. Participants in each group completed the SAMP test using one of three proposed weights (½kg, 1 kg or 1½kg). The feasibility of the SAMP test was established using structured qualitative exit feedback interviews for patients and administrating clinicians.
RESULTS


Participants using ½kg achieved the highest number of repetitions, but a high proportion reported the weight as extremely light, whereas those who tested using the 1½kg achieved the lowest number of repetitions and participants reported the weight as being heavy. Participants tested using 1 kg achieved an average number of repetitions and a high proportion reported the weight as acceptably heavy. Clinicians and patients reported that the SAMP test was efficient and convenient.
CONCLUSION


The 1 kg SAMP test is feasible for use in female patients with NSNP. The measurement properties of the SAMP test should be determined in a patient group.",2020,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[""patients and clinicians' perspectives"", 'patients and administrating clinicians', 'Seventy female patients with NSNP', 'female patients with NSNP', 'patients with NSNP', 'populations with neck pain', 'patients with neck pain']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],70.0,0.0379593,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[{'ForeName': 'Ahmad Salah Eldin', 'Initials': 'ASE', 'LastName': 'Alreni', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: Ahmad.Alreni@uantwerpen.be.'}, {'ForeName': 'Heba Roohy', 'Initials': 'HR', 'LastName': 'Abdo Aboalmaty', 'Affiliation': 'Department of Sports Training and Kinesiology, Tanta University El-Gaish Street, Tanta Qism 2, Tanta, Garbia Government, Egypt. Electronic address: hebaabdoaboalmaty@outlook.com.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: willem.dehertogh@uantwerpen.be.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Meirte', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: jill.meirte@uantwerpen.be.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrop', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: D.Harrop@shu.ac.uk.'}, {'ForeName': 'Sionnadh Mairi', 'Initials': 'SM', 'LastName': 'McLean', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: s.mclean@shu.ac.uk.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102254']
2640,32932056,"Using Empathetic CAre and REsponse (ECARE) in improving empathy and confidence among nursing and medical students when managing dangerous, aggressive and violent patients in the clinical setting.","BACKGROUND


The use of physical restraint to curtail dangerous or extremely disruptive behaviours in patients has been an established practice to help ensuring safety in healthcare providers' work environment. However, many have deemed it unnecessary and overused with reported negligence on patients' basic needs during its implementation. Studies have shown that having empathy and non-judgmental attitudes are vital in reducing and eliminating the use of restraint.
OBJECTIVES


To explore whether experiential learning will improve empathy and confidence, among nursing and medical students when managing dangerous, aggressive, and violent patients.
DESIGN


A pre- and post-test, same group quasi-experimental design was used to explore the effectiveness of using the Empathetic CAre and REsponse (ECARE), an experiential learning session to equip nursing and medical students on managing dangerous, aggressive, and violent patients. Outcome measures include students' confidence when using verbal de-escalation, physical and chemical restraint techniques. Empathy scores were also compared.
SETTINGS


A University offering both medical and nursing program from undergraduate to postgraduate level.
PARTICIPANTS


249 nursing and 50 medical students undergoing the mental health nursing module in Year 2 of their nursing program and psychiatry rotation in Year 3 of their medical education.
RESULTS


Results showed that, for both student populations, the empathy and confidence scores significantly improved after attending ECARE. ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
CONCLUSIONS


This study demonstrated that experiential learning could improve the learners' empathy through the integration of hands-on learning. This in turn could enhance future healthcare professionals' care quality. Experiential learning opportunities should be incorporated into existing pedagogies as this helps to improve students' confidence in managing dangerous, aggressive and violent patients, reducing the use of physical restraint, thereby enhancing the quality of patient care.",2020,"ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
",['249 nursing and 50 medical students undergoing the mental health nursing module in Year 2 of their nursing program and psychiatry rotation in Year 3 of their medical education'],"['Empathetic CAre and REsponse (ECARE', 'experiential learning', 'Empathetic CAre and REsponse (ECARE), an experiential learning session']","['empathy and confidence scores', 'Empathy scores', ""students' confidence when using verbal de-escalation, physical and chemical restraint techniques""]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}]","[{'cui': 'C0243012', 'cui_str': 'Active Learning'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320374', 'cui_str': 'Chemical restraint'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",249.0,0.0260366,"ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
","[{'ForeName': 'Yong-Shian', 'Initials': 'YS', 'LastName': 'Goh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore. Electronic address: nurgys@nus.edu.sg.'}, {'ForeName': 'Yu-Ting Michelle', 'Initials': 'YM', 'LastName': 'Seetoh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore.'}, {'ForeName': 'Mui-Lee', 'Initials': 'ML', 'LastName': 'Chng', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Siang Loong', 'Initials': 'SL', 'LastName': 'Ong', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Institute of Mental Health, Singapore.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore.'}, {'ForeName': 'Chun-Man Roger', 'Initials': 'CR', 'LastName': 'Ho', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Su Hui Cyrus', 'Initials': 'SHC', 'LastName': 'Ho', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}]",Nurse education today,['10.1016/j.nedt.2020.104591']
2641,32932174,"The effects of zinc supplementation on metabolic profile and oxidative stress in overweight/obese patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Evidence indicates the positive effects of zinc on insulin resistance and oxidative stress in metabolic syndrome or diabetes. Non-alcoholic fatty liver disease (NAFLD) is the main hepatic manifestation of insulin resistance and metabolic syndrome. The present study is the first clinical trial that evaluated the effects of zinc supplementation on metabolic and oxidative stress status in overweight/obese patients with NAFLD undergoing calorie- restriction diet.
METHODS


Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography were randomly allocated to receive 30 mg elemental zinc supplement (n = 29) or placebo (n = 27) along with weight loss diet for 12 weeks. Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels were assessed.
RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05). Within group comparison showed significant reduction in serum FBS, HbA 1C , TC, LDL-c and TG in the treatment group.
CONCLUSION


Zinc supplementation for three months improved insulin resistance and oxidative stress status in overweight/obese NAFLD patients with no beneficial effects on lipid profiles over weight loss diet. Registration ID in IRCT (IRCT NO: 20181005041238N1).",2020,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","['alcoholic fatty liver disease (NAFLD', 'overweight/obese patients with non-alcoholic fatty liver disease', 'metabolic syndrome or diabetes', 'overweight/obese patients with NAFLD undergoing calorie- restriction diet', 'overweight/obese NAFLD patients', 'Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography']","['Zinc supplementation', '30\u202fmg elemental zinc supplement', 'IRCT', 'placebo', 'zinc supplementation']","['Serum levels of insulin, SOD1, MDA and HOMA-IR', 'serum FBS, HbA 1C , TC, LDL-c and TG', 'metabolic and oxidative stress status', 'insulin resistance and oxidative stress status', 'Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels', 'metabolic profile and oxidative stress']","[{'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",56.0,0.385469,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","[{'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Haidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: r_amani@mail.mui.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126635']
2642,32932231,Caffeinated Chewing Gum Improves Bicycle Motocross Time-Trial Performance.,"This study aimed to identify the acute effects of caffeinated chewing gum (CAF) on bicycle motocross (BMX) time-trial (TT) performance. In a randomized, placebo-controlled, double-blind cross-over design, 14 male BMX riders (age = 20.0 ± 3.3 years; height = 1.78 ± 0.04 m; body mass = 72 ± 4 kg), consumed either (300 mg; 4.2 ± 0.2 mg/kg) caffeinated (300 mg caffeine, 6 g sugars) or a placebo (0 mg caffeine, 0 g sugars) gum, and undertook three BMX TTs. Repeated-measure analysis revealed that CAF has a large ergogenic effect on TT time, F(1, 14) = 33.570, p = .001, ηp2=.71; -1.5% ± 0.4 compared with the placebo. Peak power and maximal power to weight ratio also increased significantly compared with the placebo condition, F(1, 14) = 54.666, p = .001, ηp2=.79; +3.5% ± 0.6, and F(1, 14) = 57.399, p = .001, ηp2=.80; +3% ± 0.3, respectively. Rating of perceived exertion was significantly lower F(1, 14) = 25.020, p = .001, ηp2=.64 in CAF (6.6 ± 1.3) compared with the placebo (7.2 ± 1.7). Administering a moderate dose (300 mg) of CAF could improve TT time by enhancing power and reducing the perception of exertion. BMX coaches and riders may consider consuming CAF before a BMX race to improve performance and reduce rating of perceived exertion.",2020,"Peak power and maximal power to weight ratio also increased significantly compared with the placebo condition, F(1, 14) =","['14 male BMX riders (age = 20.0 ± 3.3\xa0years; height = 1.78 ± 0.04\xa0m; body mass = 72 ± 4\xa0kg), consumed either (300\xa0mg; 4.2 ± 0.2\xa0mg/kg']","['caffeinated (300\xa0mg caffeine, 6\xa0g sugars) or a placebo (0\xa0mg caffeine, 0\xa0g sugars) gum, and undertook three BMX TTs', 'placebo', 'Caffeinated Chewing Gum', 'caffeinated chewing gum (CAF', 'CAF']","['bicycle motocross (BMX) time-trial (TT) performance', 'Peak power and maximal power to weight ratio', 'Rating of perceived exertion', 'TT time by enhancing power and reducing the perception of exertion']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1384557', 'cui_str': 'BMX protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1384557', 'cui_str': 'BMX protein, human'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}]","[{'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",14.0,0.301819,"Peak power and maximal power to weight ratio also increased significantly compared with the placebo condition, F(1, 14) =","[{'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Daneshfar', 'Affiliation': 'University of Canterbury.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Petersen', 'Affiliation': 'University of Canterbury.'}, {'ForeName': 'Majid S', 'Initials': 'MS', 'LastName': 'Koozehchian', 'Affiliation': 'Jacksonville State University.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'Charles Darwin University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0126']
2643,32932330,Immune Response Persistence and Safety of a Booster Dose of the Tetravalent Dengue Vaccine in Adolescents and Adults Who Previously Completed the 3-dose Schedule 4-5 Years Earlier in Latin America: A Randomized Placebo-controlled Trial.,"BACKGROUND


We previously described an increased immune response 28 days after a booster dose of the live, attenuated, tetravalent dengue vaccine (CYD-TDV) in healthy adolescents and adults in Latin America (CYD64, NCT02623725). This follow-up study evaluated immune response persistence and safety of a CYD-TDV booster dose up to Month (M) 24 post-booster.
METHODS


This study included 250 participants who previously received 3 primary doses of CYD-TDV in the CYD13 (NCT00993447) and CYD30 (NCT01187433) studies, and who were randomized 4-5 years later to receive a CYD-TDV booster or placebo (3:1). Dengue neutralizing antibodies against the parental dengue virus strains were assessed using the plaque reduction neutralization test (PRNT50) at M6, M12, and M24 post-booster. Post-booster memory B-cell responses were assessed in a subset of participants using the FluoroSpot assay up to M12 post-booster.
RESULTS


In the CYD-TDV group (n = 187), dengue neutralizing antibody geometric mean titers (GMTs) declined from the peak at day 28 through to M24 for all serotypes. GMTs at M24 were similar to those at pre-booster among baseline dengue seropositives. A similar trend was observed for baseline dengue seronegatives, albeit at a lower magnitude. Previous vaccination-induced detectable B-cell memory responses in seropositives and seronegatives that decreased to pre-booster levels at M12 post-booster. The CYD-TDV booster dose was well-tolerated.
CONCLUSIONS


In baseline dengue seropositives, following a CYD-TDV booster dose administered 4-5 years after primary immunization, dengue neutralizing antibody GMTs and B-cell memory responses peaked in the short-term before gradually decreasing over time. A CYD-TDV booster dose could improve protection against dengue during outbreak periods.",2020,Previous vaccination-induced detectable B-cell memory responses in seropositives and seronegatives that decreased to pre-booster levels at M12 post-booster.,"['Adolescents and Adults', '250 participants who previously received 3 primary doses of CYD-TDV in the CYD13 (NCT00993447) and CYD30 (NCT01187433) studies, and who were randomized 4-5 years later to receive a', 'healthy adolescents and adults in Latin America']","['tetravalent dengue vaccine (CYD-TDV', 'Placebo', 'Tetravalent Dengue Vaccine', 'CYD-TDV booster or placebo']",['dengue neutralizing antibody geometric mean titers (GMTs'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}]","[{'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",250.0,0.283106,Previous vaccination-induced detectable B-cell memory responses in seropositives and seronegatives that decreased to pre-booster levels at M12 post-booster.,"[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Coronel', 'Affiliation': 'From the Clinical Sciences, Sanofi Pasteur, Mexico City, Mexico.'}, {'ForeName': 'Enid J', 'Initials': 'EJ', 'LastName': 'García-Rivera', 'Affiliation': 'Endowed Health Services Research Center, University of Puerto Rico School of Medicine, Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Doris Maribel', 'Initials': 'DM', 'LastName': 'Rivera', 'Affiliation': 'Inversiones en Investigación Médica S.A. INVERIME S.A, Tegucigalpa, Honduras.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Arredondo-García', 'Affiliation': 'Instituto Nacional de Pediatría Clinical Research Unit, Mexico City, Mexico.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Dietze', 'Affiliation': 'Universidade Federal do Espirito Santo, Núcleo de Doenças Infecciosas/CBM/UFES, Vitoria, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Perroud', 'Affiliation': 'Clinical Sciences, Sanofi Pasteur, Sao Paulo, Brazil.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Cortés', 'Affiliation': 'Global Health, Sanofi Pasteur, Bogotá, Colombia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bonaparte', 'Affiliation': 'Global Clinical Immunology, Sanofi Pasteur, Swiftwater, Pennsylvania.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Clinical Sciences and Operations, Sanofi, Beijing, China.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Pagnon', 'Affiliation': ""Research and External Innovation Department, Sanofi Pasteur, Marcy l'Etoile, France.""}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Jantet-Blaudez', 'Affiliation': ""Research and External Innovation Department, Sanofi Pasteur, Marcy l'Etoile, France.""}, {'ForeName': 'Luis Andrey Rojas', 'Initials': 'LAR', 'LastName': 'Peñalosa', 'Affiliation': 'Departamento de Producción, Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asunción, Asunción, Paraguay.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Dayan', 'Affiliation': 'Clinical Sciences, Sanofi Pasteur, Swiftwater, Pennsylvania.'}, {'ForeName': 'Betzana', 'Initials': 'B', 'LastName': 'Zambrano', 'Affiliation': 'Clinical Sciences, Sanofi Pasteur, Montevideo, Uruguay.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': ""Global Clinical Science, Sanofi Pasteur, Marcy l'Etoile, France.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Noriega', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, Pennsylvania.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002830']
2644,32932346,"Effects of Positive End-Expiratory Pressure in ""High Compliance"" Severe Acute Respiratory Syndrome Coronavirus 2 Acute Respiratory Distress Syndrome.","OBJECTIVES


Clinical observation suggests that early acute respiratory distress syndrome induced by the severe acute respiratory syndrome coronavirus 2 may be ""atypical"" due to a discrepancy between a relatively unaffected static respiratory system compliance and a significant hypoxemia. This would imply an ""atypical"" response to the positive end-expiratory pressure.
DESIGN


Single-center, unblinded, crossover study.
SETTING


ICU of Bari Policlinico Academic Hospital (Italy), dedicated to care patients with confirmed diagnosis of novel coronavirus disease 2019.
PATIENTS


Eight patients with early severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome and static respiratory compliance higher than or equal to 50 mL/cm H2O.
INTERVENTIONS


We compared a ""lower"" and a ""higher"" positive end-expiratory pressure approach, respectively, according to the intervention arms of the acute respiratory distress syndrome network and the positive end-expiratory pressure setting in adults with acute respiratory distress syndrome studies.
MEASUREMENTS AND MAIN RESULTS


Patients were ventilated with the acute respiratory distress syndrome network and, subsequently, with the ExPress protocol. After 1 hour of ventilation, for each protocol, we recorded arterial blood gas, respiratory mechanics, alveolar recruitment, and hemodynamic variables. Comparisons were performed with analysis of variance for repeated measures or Friedman test as appropriate. Positive end-expiratory pressure was increased from 9 ± 3.5 to 17.7 ± 1.7 cm H2O (p < 0.01). Alveolar recruitment was 450 ± 111 mL. Static respiratory system compliance decreased from 58.3 ± 7.6 mL/cm H2O to 47.4 ± 14.5 mL/cm H2O (p = 0.018) and the ""stress index"" increased from 0.97 ± 0.03 to 1.22 ± 0.07 (p < 0.001). The PaO2/FIO2 ratio increased from 131 ± 22 to 207 ± 41 (p < 0.001), and the PaCO2 increased from 45.9 ± 12.7 to 49.8 ± 13.2 mm Hg (p < 0.001). The cardiac index went from 3.6 ± 0.4 to 2.9 ± 0.6 L/min/m (p = 0.01).
CONCLUSIONS


Our data suggest that the ""higher"" positive end-expiratory pressure approach in patients with severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome and high compliance improves oxygenation and lung aeration but may result in alveolar hyperinflation and hemodynamic alterations.",2020,"The PaO2/FIO2 ratio increased from 131 ± 22 to 207 ± 41 (p < 0.001), and the PaCO2 increased from 45.9 ± 12.7 to 49.8 ± 13.2 mm Hg (p < 0.001).","['patients with severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome', 'adults with acute respiratory distress syndrome studies', 'High Compliance"" Severe Acute Respiratory Syndrome Coronavirus 2 Acute Respiratory Distress Syndrome', 'ICU of Bari Policlinico Academic Hospital (Italy), dedicated to care patients with confirmed diagnosis of novel coronavirus disease 2019', 'Eight patients with early severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome and static respiratory compliance higher than or equal to 50 mL/cm H2O']","['higher"" positive end-expiratory pressure approach', 'Positive End-Expiratory Pressure']","['arterial blood gas, respiratory mechanics, alveolar recruitment, and hemodynamic variables', 'Positive end-expiratory pressure', 'PaCO2', 'PaO2/FIO2 ratio', 'Static respiratory system compliance', 'stress index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1532578', 'cui_str': 'mL/cm H2O'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",8.0,0.145428,"The PaO2/FIO2 ratio increased from 131 ± 22 to 207 ± 41 (p < 0.001), and the PaCO2 increased from 45.9 ± 12.7 to 49.8 ± 13.2 mm Hg (p < 0.001).","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Grasso', 'Affiliation': 'Dipartimento dell\'Emergenza e Trapianti d\'Organo (DETO), Sezione di Anestesiologia e Rianimazione, Università degli Studi di Bari ""Aldo Moro,"" Bari, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirabella', 'Affiliation': 'Dipartimento di Dipartimento Scienze mediche e chirurgiche, Sezione anestesia e rianimazione, Università degli Studi di Foggia, Foggia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Murgolo', 'Affiliation': 'Dipartimento dell\'Emergenza e Trapianti d\'Organo (DETO), Sezione di Anestesiologia e Rianimazione, Università degli Studi di Bari ""Aldo Moro,"" Bari, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Di Mussi', 'Affiliation': 'Dipartimento dell\'Emergenza e Trapianti d\'Organo (DETO), Sezione di Anestesiologia e Rianimazione, Università degli Studi di Bari ""Aldo Moro,"" Bari, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Pisani', 'Affiliation': 'Dipartimento dell\'Emergenza e Trapianti d\'Organo (DETO), Sezione di Anestesiologia e Rianimazione, Università degli Studi di Bari ""Aldo Moro,"" Bari, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Dalfino', 'Affiliation': 'Dipartimento dell\'Emergenza e Trapianti d\'Organo (DETO), Sezione di Anestesiologia e Rianimazione, Università degli Studi di Bari ""Aldo Moro,"" Bari, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': 'Dipartimento di Morfologia, Chirurgia e Medicina Sperimentale, Sezione di Anestesiologia e Terapia Intensiva Universitaria, Università degli studi di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Rauseo', 'Affiliation': 'Dipartimento di Dipartimento Scienze mediche e chirurgiche, Sezione anestesia e rianimazione, Università degli Studi di Foggia, Foggia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lamanna', 'Affiliation': 'Dipartimento di Dipartimento Scienze mediche e chirurgiche, Sezione anestesia e rianimazione, Università degli Studi di Foggia, Foggia, Italy.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Cinnella', 'Affiliation': 'Dipartimento di Dipartimento Scienze mediche e chirurgiche, Sezione anestesia e rianimazione, Università degli Studi di Foggia, Foggia, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000004640']
2645,32932369,Clinical evaluation of a new monofocal intraocular lens with enhanced intermediate function in cataract patients.,"PURPOSE


To evaluate the effectiveness and safety of 2 enhanced monofocal intraocular lenses (IOLs). The TECNIS Eyhance IOL(Model ICB00) was compared with a standard monofocal IOL (TECNIS monofocal, Model ZCB00).
SETTING


European multicenter study.
DESIGN


Prospective, bilateral, randomized, comparative/evaluator-masked, controlled study.
METHODS


Adult subjects scheduled to undergo bilateral, primary phacoemulsification cataract extraction and posterior IOL implantation were randomized to receive the enhanced monofocal ICB00 IOL or the ZCB00 monofocal IOL in both eyes. Monocular endpoints at 6 months included distance corrected intermediate visual acuity (DCIVA), photopic corrected distance visual acuity (CDVA), and uncorrected intermediate visual acuity (UCIVA). Binocular visual acuities, monocular corrected distance contrast sensitivity (first eyes), patient-reported outcomes, and safety were assessed at 6 months.
RESULTS


Overall, 139 patients were bilaterally implanted with the enhanced monofocal IOL (n = 67) or standard monofocal IOL (n = 72) and available for the 6-month visit. The enhanced monofocal IOL significantly improved mean monocular and binocular DCIVA and UCIVA by at least 1-line logMAR vs the standard monofocal IOL (all P ≤ .0001). Distance vision for the enhanced monofocal IOL was 20/20 or better and comparable to that of the standard monofocal lens at 6 months. Contrast sensitivity, photic phenomena outcomes, and rates of adverse events were similar between the 2 groups.
CONCLUSIONS


In patients undergoing cataract surgery, TECNIS Eyhance IOL Model ICB00 provided enhanced intermediate vision and similar distance performance and photic phenomena compared with a standard monofocal IOL, along with improved functional performance in daily life.",2020,Distance vision for the enhanced monofocal IOL was 20/20 or better and comparable to that of the standard monofocal lens at 6 months.,"['patients undergoing cataract surgery', 'Adult subjects scheduled to undergo bilateral, primary phacoemulsification cataract extraction and posterior IOL implantation', '139 patients were bilaterally implanted with the enhanced monofocal IOL (n = 67) or standard monofocal IOL (n = 72) and available for the 6-month visit', 'European multicenter study', 'cataract patients']","['enhanced monofocal ICB00 IOL or the ZCB00 monofocal IOL', 'new monofocal intraocular lens', '2 enhanced monofocal intraocular lenses (IOLs', 'TECNIS Eyhance IOL Model ICB00']","['mean monocular and binocular DCIVA and UCIVA', 'effectiveness and safety', 'distance corrected intermediate visual acuity (DCIVA), photopic corrected distance visual acuity (CDVA), and uncorrected intermediate visual acuity (UCIVA', 'Contrast sensitivity, photic phenomena outcomes, and rates of adverse events', 'Distance vision', 'Binocular visual acuities, monocular corrected distance contrast sensitivity (first eyes), patient-reported outcomes, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",139.0,0.0447947,Distance vision for the enhanced monofocal IOL was 20/20 or better and comparable to that of the standard monofocal lens at 6 months.,"[{'ForeName': 'Gerd U', 'Initials': 'GU', 'LastName': 'Auffarth', 'Affiliation': 'From the International Vision Correction Research Centre (IVCRC), University-Eye-Clinic (Auffarth), Heidelberg, Heidelberg.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gerl', 'Affiliation': 'Augenklinik Ahaus (Gerl), Ahaus, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tsai', 'Affiliation': 'Johnson & Johnson Surgical Vision, Inc. (Tsai, Janakiraman, Jackson), Santa Ana, California, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Janakiraman', 'Affiliation': 'Johnson & Johnson Surgical Vision, Inc. (Tsai, Janakiraman, Jackson), Santa Ana, California, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'Johnson & Johnson Surgical Vision, Inc. (Tsai, Janakiraman, Jackson), Santa Ana, California, USA.'}, {'ForeName': 'Aixa', 'Initials': 'A', 'LastName': 'Alarcon', 'Affiliation': 'AMO (Alarcon), Groningen, the Netherlands.'}, {'ForeName': 'H Burkhard', 'Initials': 'HB', 'LastName': 'Dick', 'Affiliation': 'University Eye Hospital (Dick), Bochum, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000399']
2646,32932393,Effect of Scleral Lens Oxygen Permeability on Corneal Physiology.,"SIGNIFICANCE


This randomized, masked, crossover clinical study identifies that ≥125 Dk materials should be used for scleral lens daily wear if disruption to corneal oxygen is to be minimized.
PURPOSE


Modern scleral lens use has increased and has proven to be successful where other types and materials have previously failed. Although the required oxygen permeability has been modeled, this has not been established clinically.
METHODS


Fifteen masked participants aged 20.7 ± 2.3 years (10 female) were bilaterally fitted with five different scleral lenses (65, 100, 125, 163, and 180+ Dk) of the same shape profile and one soft silicone hydrogel lens compared with no lens wear on separate occasions in a randomized order. A masked researcher measured corneal thickness and fluid reservoir depth, corneal curvature, objective bulbar and limbal redness, corneal biomechanics, and ocular surface oxygen consumption before and after 8 hours of wear. In addition, comfort scores were obtained using a visual analog scale.
RESULTS


Scleral lenses with oxygen permeability of 65 Dk resulted in greater corneal thickness (1.37 ± 1.25%) after 8 hours of wear versus ≥100 Dk materials (0.58 ± 0.99%; F = 17.215, P < .001) because of stromal thickening; edema with ≥100 Dk materials was associated with fluid reservoir depth (r = 0.231, P = .05). Fluid reservoir depth decreased similarly with all oxygen-permeable lenses from 325.6 ± 99.1 μm to 174.2 ± 100.8 μm after 8 hours of wear (F = 0.961, P = .44). Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001). Soft and scleral lens wear had no effect on corneal curvature, corneal biomechanics, or ocular hyperemia (P > .05). Soft lenses were more comfortable than all the scleral lenses (P < .05), and the 180+ Dk lenses had the best comfort among the sclerals (P < .05).
CONCLUSIONS


A ≥125 Dk is advised for safe scleral lens daily wear. Scleral lens wear leads to an increase in corneal thickness, regardless of lens-material oxygen permeability because of the fluid reservoir depth.",2020,"Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001).","['Fifteen masked participants aged 20.7 ± 2.3 years (10 female', 'Corneal Physiology']","['Scleral Lens Oxygen Permeability', 'silicone hydrogel lens compared with no lens wear on separate occasions']","['Oxygen consumption', 'corneal thickness, regardless of lens-material oxygen permeability', 'Fluid reservoir depth', 'corneal thickness and fluid reservoir depth, corneal curvature, objective bulbar and limbal redness, corneal biomechanics, and ocular surface oxygen consumption', 'corneal thickness', 'corneal curvature, corneal biomechanics, or ocular hyperemia', 'fluid reservoir depth']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0450437', 'cui_str': 'Lens material'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0155169', 'cui_str': 'Ocular hyperemia'}]",15.0,0.0844741,"Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001).","[{'ForeName': 'Sandeep K', 'Initials': 'SK', 'LastName': 'Dhallu', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Sonia Trave', 'Initials': 'ST', 'LastName': 'Huarte', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Paramdeep S', 'Initials': 'PS', 'LastName': 'Bilkhu', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Boychev', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001557']
2647,32932394,Changes in Scleral Tonometry and Anterior Chamber Angle after Short-term Scleral Lens Wear.,"SIGNIFICANCE


Scleral lens wear can alter aqueous fluid and anterior chamber angle dynamics, leading to changes in intraocular pressure (IOP). However, there is limited information supporting this relationship between scleral lens wear, anterior chamber angle (ACA), and IOP changes in an black African population.
PURPOSE


The purpose of this study was to compare scleral IOP and ACA before, during, and after 4 hours of scleral lens wear in healthy neophyte scleral lens wearers from an black African population.
METHODS


This was a prospective study involving 20 eyes of 20 subjects with a mean ± standard deviation age of 28.7 ± 4.3 years. The study was divided into a screening and experimental phase. Scleral lenses from a diagnostic trial set were fit on a randomly selected eye. Scleral IOP was measured using a Schiotz tonometer (Winters, Jungingen, Germany) (weight, 7.5 g) on the superior-temporal sclera, and ACA was assessed using anterior segment optical coherence tomography on the temporal angle before scleral lens wear; at 10 minutes, 2 hours, and 4 hours during wear; and 10 minutes after scleral lens removal.
RESULTS


The mean ± standard deviation base curve of the scleral lens fit in the study eye was 43.4 ± 1.3 D with average tear reservoir thickness of 288.1 ± 122.0 μm at 4 hours. The mean scleral IOP before lens wear was 17.2 ± 3.5 mmHg, decreased to 16.4 ± 4.5 mmHg at 4 hours of scleral lens wear, and was 16.6 ± 3.5 mmHg 10 minutes after lens removal. The temporal ACA before scleral lens application was 43.0 ± 6.6° and varied during the 4 hours of scleral lens wear, ultimately increasing to 45.0 ± 5.4° at 10 minutes after scleral lens removal. The change in IOP and ACA was not statistically significant (F = 0.501, P = .74; and F = 2.399, P = .09, respectively).
CONCLUSIONS


Results suggest that 4 hours of nonfenestrated scleral lens wear did not have a significant impact on IOP or ACA in most of our study population.",2020,"The change in IOP and ACA was not statistically significant (F = 0.501, P = .74; and F = 2.399, P = .09, respectively).
","['healthy neophyte scleral lens wearers from an black African population', '20 eyes of 20 subjects with a mean ± standard deviation age of 28.7 ± 4.3 years']",['Scleral lenses'],"['mean scleral IOP', 'change in IOP and ACA', 'IOP or ACA', 'Scleral Tonometry and Anterior Chamber Angle', 'Scleral IOP', 'intraocular pressure (IOP']","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}]",20.0,0.0236254,"The change in IOP and ACA was not statistically significant (F = 0.501, P = .74; and F = 2.399, P = .09, respectively).
","[{'ForeName': 'Chukwuemeka Junior', 'Initials': 'CJ', 'LastName': 'Obinwanne', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}, {'ForeName': 'Damian C', 'Initials': 'DC', 'LastName': 'Echendu', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}, {'ForeName': 'Osazee', 'Initials': 'O', 'LastName': 'Agbonlahor', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Dike', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001568']
2648,32932396,Corneal Health during 3 Months of Scleral Lens Wear.,"SIGNIFICANCE


This study evaluated the effects scleral lens wear has on corneal health using fluorometry and in vivo confocal microscopy. No subclinical changes on healthy corneas of young subjects were observed during 3 months of scleral lens wear.
PURPOSE


This study aimed to evaluate the effects 3 months of scleral lens wear has on the corneal epithelial barrier function, dendritic cell density, and nerve fiber morphology.
METHODS


Twenty-seven neophytes (mean [standard deviation] age, 21.4 [3.9] years) wore scleral lenses of a fluorosilicone acrylate material bilaterally (97 Dk, 15.6 to 16.0-mm diameter) for 3 months without overnight wear. Subjects were randomized to use either Addipak (n = 12) or PuriLens Plus (n = 15) during lens insertion. Measurements of corneal epithelial permeability to fluorescein were performed with automated scanning fluorophotometer (Fluorotron Master; Ocumetrics, Mountain View, CA) on the central cornea of the right eye and the temporal corneal periphery of the left eye. Images of the distributions of corneal nerve fibers and dendritic cells and nerve fibers were captured in vivo with a confocal laser scanning microscope (Heidelberg Retina Tomograph, Rostock Cornea Module; Heidelberg Engineering, Heidelberg, Germany) on the central and inferior peripheral cornea of the left eye. Corneal measurements and imaging were performed at baseline and after 1 and 3 months of lens wear.
RESULTS


The corneal permeability values in natural log, dendritic cell densities, and nerve fiber morphology did not significantly change from baseline to 1 and 3 months of lens wear, for both central and peripheral corneal regions (P > .05). Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001). No relationships were observed between each outcome measurements and the saline solution groups (P > .05).
CONCLUSIONS


Scleral lens wear for 3 months on healthy cornea of young subjects did not affect corneal epithelial barrier function, nerve fiber, and dendritic cell densities. Buffered and nonbuffered saline solutions impacted the corneal health in similar ways.",2020,Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001).,"['Twenty-seven neophytes (mean [standard deviation] age, 21.4 [3.9] years) wore scleral lenses of a fluorosilicone acrylate material bilaterally (97 Dk, 15.6 to 16.0-mm diameter) for 3 months without overnight wear']","['Addipak (n = 12) or PuriLens Plus', 'Buffered and nonbuffered saline solutions']","['corneal epithelial barrier function, dendritic cell density, and nerve fiber morphology', 'corneal permeability values in natural log, dendritic cell densities, and nerve fiber morphology', 'corneal health', 'Corneal Health', 'corneal epithelial permeability', 'corneal epithelial barrier function, nerve fiber, and dendritic cell densities', 'Dendritic cell density']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0101303', 'cui_str': 'acrylate'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0498456,Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001).,"[{'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Tse', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Yixiu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Truong', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Meng C', 'Initials': 'MC', 'LastName': 'Lin', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001566']
2649,32932401,Effects of Combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial.,"OBJECTIVE


To examine the impact of a single-capsule 17β-estradiol (E2)/progesterone (P4) on weight and blood pressure (BP) when treating moderate to severe vasomotor symptoms in postmenopausal women with a uterus.
METHODS


Healthy postmenopausal women with a uterus (aged 40-65, body mass index ≤34 kg/m, BP ≤140/90 mm Hg) were randomized to daily E2/P4 (mg/mg; 1/100, 0.5/100, 0.5/50, 0.25/50) or placebo in the phase 3 REPLENISH trial (NCT01942668). Changes in weight and BP from baseline to month 12 were evaluated. Potentially clinically important changes were defined as increases or decreases from baseline in weight by ≥15% and ≥11.3 kg, systolic BP by ≥20 mm Hg (absolute value ≥160 or ≤90 mm Hg), and diastolic BP by ≥15 mm Hg (absolute value ≥90 or ≤60 mm Hg).
RESULTS


Overall mean changes in weight and BP from baseline to month 12 with E2/P4 were modest and generally not statistically or clinically significant versus placebo. Incidence of potentially clinically important changes was low for weight (E2/P4 vs placebo: 1.1-2.6% vs 2.2%), systolic BP (0.3-1.1% vs 1.1%), and diastolic BP (1.4-4.2% vs 3.2%). A small number of women had treatment-related, treatment-emergent adverse events of weight gain (1.4-2.6% vs 1.3%) or hypertension (0.2-1.2% vs 0%). Few women who discontinued E2/P4 had weight gain (1.6%) or hypertension (0.6%) as a primary reason. Efficacy profile on VMS was consistent with previous findings and not modified by body mass index.
CONCLUSIONS


Twelve-month use of E2/P4 had no clinically meaningful impact on weight or BP in postmenopausal women of the REPLENISH study.",2020,Overall mean changes in weight and BP from baseline to month 12 with E2/P4 were modest and generally not statistically or clinically significant versus placebo.,"['postmenopausal women with a uterus', 'Healthy postmenopausal women with a uterus (aged 40-65, body mass index ≤34\u200akg/m, BP ≤140/90 mm Hg', 'postmenopausal women']","['Combined 17β-estradiol and progesterone', 'placebo', 'VMS', 'single-capsule 17β-estradiol (E2)/progesterone (P4']","['systolic BP', 'weight gain', 'weight and BP', 'weight and blood pressure', 'weight and blood pressure (BP', 'hypertension', 'diastolic BP', 'weight or BP']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.302291,Overall mean changes in weight and BP from baseline to month 12 with E2/P4 were modest and generally not statistically or clinically significant versus placebo.,"[{'ForeName': 'Denise R', 'Initials': 'DR', 'LastName': 'Black', 'Affiliation': 'University of Manitoba, Winnipeg MB, Canada.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Minkin', 'Affiliation': 'School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001659']
2650,32932424,A Self-Efficacy Reinforcement Stretching Exercise Program for Community-Dwelling Older Women With Osteoarthritis: A Pilot Study.,"PURPOSE


This study evaluated the effectiveness of the Self-Efficacy Reinforcement Stretching Exercise Program to improve osteoarthritis (OA)-related symptoms in older women with OA.
DESIGN


A quasi-experimental design was used in this study.
METHODS


The experimental group participated in the Self-Efficacy Reinforcement Stretching Exercise Program, a 6-week program composed of stretching exercises and self-efficacy reinforcement strategies, whereas the control group did not. All participants were assessed on pain; joint stiffness; physical function disability; body mass index; depression; and quality of life at the beginning, end, and 4 weeks after the program ended.
FINDINGS


After participation, the experimental group had significantly less joint stiffness, physical function disability, and depression scores and significantly higher self-efficacy and quality of life than the control group.
CONCLUSIONS


This intervention program led to an improvement in OA-related symptoms, self-efficacy, and quality of life in older women with OA.
CLINICAL RELEVANCE


The sustained effects of acquired exercise behaviors that persisted up to 4 weeks after the program ended could be of interest to rehabilitation nurses and other healthcare professionals.",2020,"This intervention program led to an improvement in OA-related symptoms, self-efficacy, and quality of life in older women with OA.
","['older women with OA', 'Community-Dwelling Older Women With Osteoarthritis']",['Self-Efficacy Reinforcement Stretching Exercise Program'],"['joint stiffness, physical function disability, and depression scores', 'OA-related symptoms, self-efficacy, and quality of life', 'self-efficacy and quality of life', 'pain; joint stiffness; physical function disability; body mass index; depression; and quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0229898,"This intervention program led to an improvement in OA-related symptoms, self-efficacy, and quality of life in older women with OA.
","[{'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Cho', 'Affiliation': 'College of Nursing, Korea University, Seongbuk-gu, Republic of Korea.'}]",Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/RNJ.0000000000000290']
2651,32932576,Evaluation of the Pharmacokinetic Drug-Drug Interaction between Micronized Fenofibrate and Pitavastatin in Healthy Volunteers.,"Dyslipidemia is a major risk factor for development of atherosclerosis and cardiovascular disease (CVD). Effective lipid-lowering therapies has led to CVD risk reduction. This study evaluated the possible pharmacokinetic interactions between fenofibrate, a peroxisome proliferators-activated receptors α agonist, and pitavastatin, a 3-hydoxy-3-methylglutaryl-coenzyme A reductase inhibitor, in healthy Korean subjects. The study design was an open-label, randomized, multiple-dose, three-period, and six-sequence crossover study with a 10-day washout in 24 healthy volunteers. It had three treatments: 160 mg of micronized fenofibrate once daily for 5 days; 2 mg of pitavastatin once daily for 5 days; and 160 mg of micronized fenofibrate with 2 mg of pitavastatin for 5 days. Serial blood samples were collected at scheduled intervals for up to 48 h after the last dose in each period to determine the steady-state pharmacokinetics of both drugs. Plasma concentrations of fenofibric acid and pitavastatin were measured using a validated high-performance liquid chromatography with the tandem mass spectrometry method. A total of 24 subjects completed the study. Pitavastatin, when co-administered with micronized fenofibrate, had no effect on the C max,ss  and AUC τ,ss  of fenofibric acid. The C max,ss  and AUC τ,ss  of pitavastatin were increased by 36% and 12%, respectively, when co-administered with fenofibrate. Combined treatment with pitavastatin and micronized fenofibrate was generally well tolerated without serious adverse events. Our results demonstrated no clinically significant pharmacokinetic interactions between micronized fenofibrate and pitavastatin when 160 mg of micronized fenofibrate and 2 mg of pitavastatin are co-administered. The treatments were well tolerated during the study, with no serious adverse events.",2020,"The C max,ss  and AUC τ,ss  of pitavastatin were increased by 36% and 12%, respectively, when co-administered with fenofibrate.","['24 healthy volunteers', 'healthy Korean subjects', 'Healthy Volunteers', '24 subjects completed the study']","['micronized fenofibrate', 'pitavastatin', 'pitavastatin and micronized fenofibrate', 'micronized fenofibrate and pitavastatin', 'Pitavastatin', 'fenofibrate', 'Micronized Fenofibrate and Pitavastatin']","['C max,ss  and AUC τ,ss  of fenofibric acid', 'tolerated without serious adverse events', 'C max,ss  and AUC τ,ss  of pitavastatin', 'Plasma concentrations of fenofibric acid and pitavastatin', 'pharmacokinetic interactions', 'Serial blood samples']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0060179', 'cui_str': 'Fenofibric acid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",24.0,0.019179,"The C max,ss  and AUC τ,ss  of pitavastatin were increased by 36% and 12%, respectively, when co-administered with fenofibrate.","[{'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Woo Youl', 'Initials': 'WY', 'LastName': 'Kang', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Wookjae', 'Initials': 'W', 'LastName': 'Jung', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Mi-Ri', 'Initials': 'MR', 'LastName': 'Gwon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Kyunghee', 'Initials': 'K', 'LastName': 'Cho', 'Affiliation': 'Analytical Research Division, Biocore Co. Ltd., Seoul 08511, Korea.'}, {'ForeName': 'Dong Heon', 'Initials': 'DH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu 41944, Korea.'}, {'ForeName': 'Young-Ran', 'Initials': 'YR', 'LastName': 'Yoon', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}, {'ForeName': 'Sook Jin', 'Initials': 'SJ', 'LastName': 'Seong', 'Affiliation': 'Department of Molecular Medicine, School of Medicine, Kyungpook National University and Department of Clinical Pharmacology, Kyungpook National University Hospital, Daegu 41566, Korea.'}]",Pharmaceutics,['10.3390/pharmaceutics12090869']
2652,32932584,Hyperhomocysteinemia Induced by Methionine Excess Is Effectively Suppressed by Betaine in Geese.,"The objective of our study was to investigate the effects of excess Methionine (Met) on the growth performance, serum homocysteine levels, apoptotic rates, and Bax and Bcl-2 protein levels in geese and to study the role of Bet (betaine) in relieving excess Met-induced hyperhomocysteinemia (HHcy). In this study, 150 healthy male 14-day-old Yangzhou geese of similar body weight were randomly distributed into three groups with five replicates per treatment and 10 geese per replicate: the control group (fed a control diet), the Met toxicity group (fed the control diet +1% Met), and the Bet detoxification group (fed the control diet +1% Met +0.2% Bet). At 28, 49, and 70 d of age, the geese in the Met toxicity group had significantly lower body weights than those in the control group ( p  < 0.05). The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05). Compared with the control, Met significantly increased cardiomyocyte apoptosis rates, while Bet reduced them. In conclusion, our results suggest that excess methionine reduces body weight induced by myocardial apoptosis, and Bet can be used to effectively lower plasma homocysteine levels.",2020,The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05).,['150 healthy male 14-day-old Yangzhou geese of similar body weight'],"['control group (fed a control diet), the Met toxicity group (fed the control diet +1% Met), and the Bet detoxification group (fed the control diet +1% Met +0.2% Bet', 'excess Methionine (Met']","['growth performance, serum homocysteine levels, apoptotic rates, and Bax and Bcl-2 protein levels', 'body weights', 'cardiomyocyte apoptosis rates', 'serum homocysteine levels', 'body weight', 'plasma homocysteine levels']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017225', 'cui_str': 'Anser'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1278080', 'cui_str': 'Serum homocysteine measurement'}, {'cui': 'C0219474', 'cui_str': 'Bax Protein'}, {'cui': 'C4042483', 'cui_str': 'BCL2 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0225828', 'cui_str': 'Cardiac myocyte'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C1278165', 'cui_str': 'Plasma homocysteine measurement'}]",150.0,0.0147092,The serum homocysteine levels in geese at 70 d of age in the detoxification group were significantly lower than those in the Met toxicity group ( p  < 0.05).,"[{'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Joint International Research Laboratory of Agriculture and Agri-Product Safety of the Ministry of Education of China, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Haiming', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'College of Animal Science and Technology, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}, {'ForeName': 'Zhiyue', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Joint International Research Laboratory of Agriculture and Agri-Product Safety of the Ministry of Education of China, Yangzhou University, Yangzhou 225009, Jiangsu Province, China.'}]",Animals : an open access journal from MDPI,['10.3390/ani10091642']
2653,32932604,"Effect of a Combination of Myo-Inositol, Alpha-Lipoic Acid, and Folic Acid on Oocyte Morphology and Embryo Morphokinetics in non-PCOS Overweight/Obese Patients Undergoing IVF: A Pilot, Prospective, Randomized Study.","Herein we aimed at assessing whether Myo-Inositol (MI), Alpha-Lipoic acid (ALA), and Folic acid (FA) could improve oocyte quality and embryo development in non-PCOS overweight/obese women undergoing IVF. Three hundred and twenty-four mature oocytes were obtained from non-PCOS overweight/obese patients, randomized to receive either MI, ALA, and FA (MI + ALA + FA group,  n  = 155 oocytes) or FA alone (FA-only group,  n  = 169 oocytes). Oocytes were examined using Polarized Light Microscopy to assess morphological features of zona pellucida (ZP) and meiotic spindle (MS). One hundred and seventy-six embryos ( n  = 84 in the MI + ALA + FA group,  n  = 92 in the FA-only group) were assessed by conventional morphology on days 2 and 5, as well as using the Time-Lapse System morphokinetic analysis. A significantly higher ZP retardance, area, and thickness ( p  < 0.05), and a shorter MS axis ( p  < 0.05) were observed in the MI + ALA + FA group, suggesting a positive effect on oocyte quality. Conventional morphology evaluation on day 2 showed a higher mean embryo score in the MI + ALA + FA group, whereas embryo morphokinetic was comparable in the two groups. Overall, our data show a possible beneficial effect of the combination of MI, ALA, and FA on oocyte and embryo morphology, encouraging testing of this combination in adequately powered randomized trials to assess their impact of clinical IVF results.",2020,"A significantly higher ZP retardance, area, and thickness ( p  < 0.05), and a shorter MS axis ( p  < 0.05) were observed in the MI + ALA + FA group, suggesting a positive effect on oocyte quality.","['non-PCOS Overweight/Obese Patients Undergoing IVF', 'One hundred and seventy-six embryos ( n  = 84 in the', 'Three hundred and twenty-four mature oocytes were obtained from non-PCOS overweight/obese patients', 'non-PCOS overweight/obese women undergoing IVF']","['MI + ALA + FA', 'MI, ALA, and FA (MI + ALA + FA group,  n  ', 'FA alone (FA', 'Myo-Inositol (MI), Alpha-Lipoic acid (ALA), and Folic acid (FA', 'Combination of Myo-Inositol, Alpha-Lipoic Acid, and Folic Acid']","['ZP retardance, area, and thickness', 'shorter MS axis', 'oocyte quality and embryo development', 'morphological features of zona pellucida (ZP) and meiotic spindle (MS', 'mean embryo score', 'Oocyte Morphology and Embryo Morphokinetics', 'embryo morphokinetic', 'oocyte quality']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013936', 'cui_str': 'Embryo Development'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0043519', 'cui_str': 'Zona Pellucida'}, {'cui': 'C3268864', 'cui_str': 'Meiotic Spindle'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",324.0,0.0476783,"A significantly higher ZP retardance, area, and thickness ( p  < 0.05), and a shorter MS axis ( p  < 0.05) were observed in the MI + ALA + FA group, suggesting a positive effect on oocyte quality.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Canosa', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Paschero', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carosso', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Leoncini', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Mercaldo', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Gennarelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Benedetto', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelli', 'Affiliation': 'Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, S. Anna Hospital, Department of Surgical Sciences, University of Torino, Via Ventimiglia 3, 10126 Torino, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9092949']
2654,32932611,"Pre-Competition Weight Loss Models in Taekwondo: Identification, Characteristics and Risk of Dehydration.","Athletes use different combinations of weight loss methods during competition preparation. The aim of this study was to identify and characterize pre-competition weight loss models, which describe these combinations. The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option. The third aim was to explore whether athletes who used different weight management strategies could be differentiated based on age, sex, training experience or anthropometric parameters. Study participants were randomly selected from Olympic taekwondo competitors and 192 athletes were enrolled. Active (47% weight-reducing athletes), passive (31%) and extreme (22%) models have been described. In the extreme model, athletes combined the highest number of different weight loss methods (3.9 ± 0.9 methods vs. 2.4 ± 0.9 in active and 1.5 ± 0.6 in passive), reduced significantly more body mass than others (6.7 ± 3.5% body mass vs. 4.3 ± 1.9% and 4.5 ± 2.4%;  p  < 0.01) and all of them used methods with the highest risk of severe dehydration. The active and passive models could be continued as a lower-risk option, if athletes do not combine dehydrating methods and do not prolong the low energy availability phase. The extreme model carried the highest risk of severe dehydration. Every fifth weight-reducing taekwondo athlete may have been exposed to the adverse effects of acute weight loss. Taekwondo athletes, regardless of age, sex, training experience and anthropometric parameters, lose weight before the competition and those characteristics do not differentiate them between models.",2020,The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option.,['Study participants were randomly selected from Olympic taekwondo competitors and 192 athletes were enrolled'],[],['body mass'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",192.0,0.0386025,The second aim was to determine if any existing model pose a higher risk of severe dehydration and whether any of the models could be continued as a lower-risk option.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Janiszewska', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury in Olsztyn, Słoneczna 45F Str., 10-718 Olsztyn, Poland.'}, {'ForeName': 'Katarzyna E', 'Initials': 'KE', 'LastName': 'Przybyłowicz', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury in Olsztyn, Słoneczna 45F Str., 10-718 Olsztyn, Poland.'}]",Nutrients,['10.3390/nu12092793']
2655,32932771,Effects of a Nine-Month Physical Activity Intervention on Morphological Characteristics and Motor and Cognitive Skills of Preschool Children.,"(1) Background: Regular physical activity (PA) plays an important role during early childhood physical and psychological development. This study investigates the effects of a 9-month PA intervention on physiological characteristics and motor and cognitive skills in preschool children. (2) Methods: Preschool children ( n  = 132; age 4 to 7 years) attending regular preschool programs were nonrandomly assigned to PA intervention ( n  = 66; 60 min sessions twice per week) or a control group ( n  = 66; no additional organized PA program) for 9 months. Exercise training for the intervention group included various sports games, outdoor activities, martial arts, yoga, and dance. Anthropometry, motor skills (7 tests), and cognitive skills (Raven's Colored Progressive Matrices and Cognitive Assessment System) were assessed before and after an intervention period in both groups. Data were analyzed using repeated-measures ANOVA. (3) Results: Body weight significantly increased in both groups over time. Compared to the changes observed in the control group, the intervention group significantly increased in chest circumference ( p  = 0.022). In contrast, the control group demonstrated an increase in waist circumference ( p  = 0.001), while these measures in the intervention group remained stable. Participants in the intervention group improved running speed ( p  = 0.016) and standing broad jump ( p  = 0.000). The flexibility level was maintained in the intervention group, while a significant decrease was observed in the control group ( p  = 0.010). Children from the intervention group demonstrated progress in the bent-arm hang test ( p  = 0.001), unlike the control group subjects. Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements. (4) Conclusions: Preschool children's participation in a preschool PA intervention improves their motor skills.",2020,"Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements.","['Preschool Children', ""Preschool children's"", 'preschool children', 'Preschool children ( n  = 132; age 4 to 7 years) attending regular preschool programs']","['Exercise training', 'Regular physical activity (PA', 'preschool PA intervention', 'Nine-Month Physical Activity Intervention', 'control group ( n  = 66; no additional organized PA program', 'PA intervention']","['chest circumference', 'flexibility level', 'motor skills', 'running speed', 'Morphological Characteristics and Motor and Cognitive Skills', 'waist circumference', 'physiological characteristics and motor and cognitive skills', 'cognitive skills', ""Anthropometry, motor skills (7 tests), and cognitive skills (Raven's Colored Progressive Matrices and Cognitive Assessment System"", 'Body weight']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424683', 'cui_str': 'Chest circumference'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1449597', 'cui_str': 'Corvus corax'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",132.0,0.0149852,"Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements.","[{'ForeName': 'Damjan', 'Initials': 'D', 'LastName': 'Jaksic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mandic', 'Affiliation': 'Active Living Laboratory, School for Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin 9016, New Zealand.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Maksimovic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Milosevic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Roklicer', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Jovan', 'Initials': 'J', 'LastName': 'Vukovic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Suncica', 'Initials': 'S', 'LastName': 'Pocek', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nemanja', 'Initials': 'N', 'LastName': 'Lakicevic', 'Affiliation': 'PhD Program in Health Promotion and Cognitive Sciences, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Sport and Exercise Science Research Unit, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cassar', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong 3216, Australia.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Drid', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186609']
2656,32932891,Comparison between Conventional Blind Injections and Ultrasound-Guided Injections of Botulinum Toxin Type A into the Masseter: A Clinical Trial.,"The aim of the study was to propose a more efficient and safer botulinum toxin type A (BoNT-A) injection method for the masseter by comparing the conventional blind injection and a novel ultrasonography (US)-guided injection technique in a clinical trial. The 40 masseters from 20 healthy young Korean volunteers (10 males and 10 females with a mean age of 25.6 years) were included in this prospective clinical trial. The BoNT-A (24 U) was injected into the masseter of each volunteer using the conventional blind and US-guided injection techniques on the left and right sides, respectively, and analyzed by US and three-dimensional (3D) facial scanning. One case of PMB (paradoxical masseteric bulging) was observed on the side where a conventional blind injection was performed, which disappeared after the compensational injection. The reduction in the thickness of the masseter in the resting state differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 12.38 ± 7.59% and 17.98 ± 9.65%, respectively ( t (19) = 3.059,  p  = 0.007). The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) = 2.908,  p  = 0.009). The results of the study showed that the US-guided injection method that considers the deep inferior tendon by visualizing the masseter can prevent the PMB that can occur during a blind injection, and is also more effective.",2020,"The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) =","['20 healthy young Korean volunteers (10 males and 10 females with a mean age of 25.6 years', 'Masseter']","['novel ultrasonography (US)-guided injection technique', 'botulinum toxin type A (BoNT-A) injection method', 'Botulinum Toxin Type']",['facial contour'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0456651', 'cui_str': 'Method of injection'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}]",20.0,0.0380531,"The reduction in the facial contour also differed significantly at 1 month after the injection between the conventional blind injection group and the US-guided injection group by 1.95 ± 0.74 mm and 2.22 ± 0.84 mm, respectively ( t (19) =","[{'ForeName': 'Hyungkyu', 'Initials': 'H', 'LastName': 'Bae', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Jisoo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Youth Clinic, 30 Apgujeong-ro 80-gil, Gangnam-gu, Seoul 03722, Korea.'}, {'ForeName': 'Kyle K', 'Initials': 'KK', 'LastName': 'Seo', 'Affiliation': 'Modelo Clinic, 21 Apgujeong-ro 60-gil, Gangnam-gu, Seoul 03722, Korea.'}, {'ForeName': 'Kyung-Seok', 'Initials': 'KS', 'LastName': 'Hu', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Seong-Taek', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Orofacial Pain and Oral Medicine, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}, {'ForeName': 'Hee-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, BK21 PLUS Project, Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.'}]",Toxins,['10.3390/toxins12090588']
2657,32932898,Evaluation of Salivary Matrix Metalloproteinase (MMP-8) in Periodontal Patients Undergoing Non-Surgical Periodontal Therapy and Mouthwash Based on Ozonated Olive Oil: A Randomized Clinical Trial.,"Background : Extracellular matrix metalloproteinases (MMPs) play a pivotal role in the damage to the periodontal tissue in patients with periodontitis. Scaling and root planning (SRP) attempt to control the plaque amount and consequentially reduce the bacterial load. Non-surgical periodontal treatment could be integrated with drug therapy and physiotherapy procedures such as ozone therapy. The aim of this study was to evaluate in a cohort of patients with a diagnosis of periodontitis: (1) the efficacy of non-surgical periodontal therapy assisted by the use of ozonated olive oil-based mouthwash on salivary metalloproteinase (MMP-8) and (2) the reduction of periodontal indices.  Methods : Ninety-six subjects with a diagnosis of periodontitis were enrolled in this study and randomly assigned to the study group (SRP + mouthwash) or control group (SRP). The study duration was 3 months. Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's  t -test for independent samples.  Results:  A significant improvement in PI, BoP, PPD and salivary MMP-8 levels was observed in both groups. An analysis of differences in relative changes of indices revealed the efficacy of ozonated olive oil in decreasing MMP-8 level. Simultaneously, it slowed the decrease of BoP index.  Conclusions:  Scaling and root plaining with the aid of ozonated olive oil mouthwash were found to be more effective on salivary MMP-8 reduction than scaling and root plaining alone.",2020,"Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months).","['patients with periodontitis', 'Periodontal Patients Undergoing Non-Surgical Periodontal Therapy and Mouthwash Based on Ozonated Olive Oil', 'patients with a diagnosis of periodontitis', 'Ninety-six subjects with a diagnosis of periodontitis']","['study group (SRP + mouthwash) or control group (SRP', 'ozonated olive oil-based mouthwash', 'ozonated olive oil', 'Scaling and root planning (SRP', 'Salivary Matrix Metalloproteinase (MMP-8', ' ']","['salivary MMP-8 reduction', 'PI, BoP, PPD and salivary', 'MMP-8 level', 'BoP index', 'MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD', 'MMP-8 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",96.0,0.033528,"Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months).","[{'ForeName': 'Gianna Maria', 'Initials': 'GM', 'LastName': 'Nardi', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cesarano', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Papa', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Chiavistelli', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Ardan', 'Affiliation': 'Chair of Econometrics, Department of Economic Sciences, Koszalin University of Technology, 75-343 Koszalin, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Jedlinski', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University in Szczecin, 70-111 Szczecin, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mazur', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Grassi', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, 07100 Sassari, Italy.'}, {'ForeName': 'Felice Roberto', 'Initials': 'FR', 'LastName': 'Grassi', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, Aldo Moro University of Bari, 70122 Bari, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17186619']
2658,32932997,Virtual Reality-Based Cognitive-Motor Rehabilitation in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Study on Motivation and Cognitive Function.,"The purpose of this study was to investigate the effects of virtual reality-based cognitive-motor rehabilitation (VRCMR) on the rehabilitation motivation and cognitive function in older adults. This study enrolled 40 older adults with mild cognitive impairment (MCI), living in the community. The subjects were randomly assigned to a VRCMR group ( n  = 20) or a conventional cognitive rehabilitation (CCR) group ( n  = 20). The VRCMR group underwent VRCMR using MOTOcog, a computer recognition program, whereas the CCR group underwent conventional cognitive rehabilitation, which included puzzles, wood blocks, card play, stick construction activity, and maze activity. Both interventions were performed 30 min per day, 5 days/week, for 6 weeks. This study performed a cognitive assessment using the Montreal Cognitive Assessment (MoCA) scale, Trail Making Test A and B (TMT-A/B), and Digit Span Test forward and backward (DST-forward/backward). In addition, a 0-to-10 numeric rating self-report scale was used to assess interest and motivation during the rehabilitation training. After the intervention, the VRCMR group showed a significantly greater improvement in the MoCA ( p  = 0.045), TMT-A ( p  = 0.039), TMT-B ( p  = 0.040), and DST-forward ( p  = 0.011) scores compared to the CCR group, but not in the DST-backward score ( p  = 0.424). In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group. Cohen's d effect size was 0.4, 0.3, 0.35, 0.4, and 0.5 for the MoCA, TMT-A, TMT-B, DST-forward, and DST-backward tests, respectively. This study demonstrates that VRCMR enhances motivation for rehabilitation and cognitive function in older adults with MCI better than CCR.",2020,"In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group.","['older adults', '40 older adults with mild cognitive impairment (MCI), living in the community', 'older adults with MCI better than CCR', 'Older Adults with Mild Cognitive Impairment']","['VRCMR', 'Virtual Reality-Based Cognitive-Motor Rehabilitation', 'conventional cognitive rehabilitation (CCR', 'virtual reality-based cognitive-motor rehabilitation (VRCMR']","['MoCA', 'Motivation and Cognitive Function', 'motivation', 'Montreal Cognitive Assessment (MoCA) scale, Trail Making Test A and B (TMT-A/B), and Digit Span Test forward and backward (DST-forward/backward']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1955905', 'cui_str': 'CCR Receptors'}]","[{'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}]",40.0,0.0188254,"In addition, subjects in the experimental group had significantly higher interest ( p  = 0.03) and motivation ( p  = 0.03) than those in the control group.","[{'ForeName': 'Ji-Su', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Advanced Human Resource Development Project Group for Health Care in Aging Friendly, Industry, Dongseo University, Busan 47011, Korea.'}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Jung', 'Affiliation': 'Department of Radiological Science at Health Sciences Division in DongSeo University, Busan 47011, Korea.'}, {'ForeName': 'Gihyoun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135701, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030335']
2659,31815678,"Analysis of the Implementation, User Perspectives, and Feedback From a Mobile Health Intervention for Individuals Living With Hypertension (DREAM-GLOBAL): Mixed Methods Study.","BACKGROUND


DREAM-GLOBAL (Diagnosing hypertension-Engaging Action and Management in Getting Lower Blood Pressure in Indigenous and low- and middle-income countries) studied a SMS text messaging-based system for blood pressure measurement and hypertension management in Canadian Aboriginal and Tanzanian communities. The use of SMS text messages is an emerging point of interest in global health care initiatives because of their scalability, customizability, transferability, and cost-effectiveness.
OBJECTIVE


The study aim was to assess the effect on the difference in blood pressure reduction of active hypertension management messages or passive health behavior messages. The system was designed to be implemented in remote areas with wireless availability. This study described the implementation and evaluation of technical components, including quantitative data from the transmission of blood pressure measurements and qualitative data collected on the operational aspects of the system from participants, health care providers, and community leadership.
METHODS


The study was implemented in six remote Indigenous Canadian and two rural Tanzanian communities. Blood pressure readings were taken by a community health worker and transmitted to a mobile phone via Bluetooth, then by wireless to a programmed central server. From the server, the readings were sent to the participant's own phone as well. Participants also received biweekly tailored SMS text messages on their phones. Quantitative data on blood pressure reading transmissions were collected from the study central server. Qualitative data were collected by surveys, focus groups, and key informant interviews of participants, health care providers, and health leadership.
RESULTS


In Canada, between February 2014 and February 2017, 2818 blood pressure readings from 243 patients were transmitted to the central server. In Tanzania, between October 2014 and August 2015, 1165 readings from 130 patients were transmitted to the central server. The use of Bluetooth technology enabled the secure, reliable transmission of information from participants to their health care provider. The timing and frequency were satisfactory to 137 of 187 (73.2%) of participants, supporting the process of sending weekly messages twice on Mondays and Thursdays at 11 am. A total of 97.0% (164/169) of the participants surveyed said they would recommend participation in the DREAM-GLOBAL program to a friend or relative with hypertension.
CONCLUSIONS


In remote communities, the DREAM-GLOBAL study helped local health care providers deliver a blood pressure management program that enabled patients and community workers to feel connected. The technical components of the study were implemented as planned, and patients felt supported in their management through the SMS text messaging and mobile health program. Technological issues were solved with troubleshooting. Overall, the technical aspects of this research program enhanced clinical care and study evaluation and were well received by participants, health care workers, and community leadership.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226.",2019,"A total of 97.0% (164/169) of the participants surveyed said they would recommend participation in the DREAM-GLOBAL program to a friend or relative with hypertension.
","['six remote Indigenous Canadian and two rural Tanzanian communities', 'participants, health care providers, and community leadership', 'Individuals Living With Hypertension', 'Canadian Aboriginal and Tanzanian communities', 'In Tanzania, between October 2014 and August 2015, 1165 readings from 130 patients were transmitted to the central server', 'In Canada, between February 2014 and February 2017, 2818 blood pressure readings from 243 patients were transmitted to the central server', 'participants to their health care provider']",['biweekly tailored SMS text messages'],"['blood pressure reading transmissions', 'Blood pressure readings']","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1705194', 'cui_str': 'Computer network server'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]",243.0,0.0472923,"A total of 97.0% (164/169) of the participants surveyed said they would recommend participation in the DREAM-GLOBAL program to a friend or relative with hypertension.
","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Barsky', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McAllister', 'Affiliation': 'Perspect Management Consulting, Regina, SK, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yeates', 'Affiliation': 'Department of Medicine, Queens University, Kingston, ON, Canada.'}, {'ForeName': 'Norm', 'Initials': 'N', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Perkins', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hua-Stewart', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marion A', 'Initials': 'MA', 'LastName': 'Maar', 'Affiliation': 'Faculty of Medicine, Northern Ontario School of Medicine, Sudbury, ON, Canada.'}, {'ForeName': 'Sheldon W', 'Initials': 'SW', 'LastName': 'Tobe', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}]",JMIR mHealth and uHealth,['10.2196/12639']
2660,31845901,Development and Local Contextualization of Mobile Health Messages for Enhancing Disease Management Among Community-Dwelling Stroke Patients in Rural China: Multimethod Study.,"BACKGROUND


Rural China has experienced an increasing health burden because of stroke. Stroke patients in rural communities have relatively poor awareness of and adherence to evidence-based secondary prevention and self-management of stroke. Mobile technology represents an innovative way to influence patient behaviors and improve their self-management.
OBJECTIVE


This study is part of the System-Integrated Technology-Enabled Model of Care (the SINEMA trial) to improve the health of stroke patients in resource-poor settings in China. This study aimed to develop and pilot-test a mobile phone message-based package, as a component of the SINEMA intervention.
METHODS


The SINEMA trial was conducted in Nanhe County, Hebei Province, China. A total of 4 villages were selected for pretrial contextual research and pilot study. The 5 stages for developing the mobile phone messages were as follows: (1) conducting literature review on existing message banks and analyzing the characteristics of these banks; (2) interviewing stroke patients and caregivers to identify their needs; (3) drafting message contents and designing dispatching algorithms for a 3-month pilot testing; (4) collecting feedback from pilot participants through questionnaire survey and in-depth interviews on facilitators and barriers related to their acceptance and understanding of messages; and (5) finalizing the message-based intervention based on participants' feedback for the SINEMA trial.
RESULTS


On the basis of 5 existing message banks screened out of 120 papers and patients' needs identified from 32 in-depth interviews among stroke patients and caregivers, we developed a message bank containing 224 messages for a pilot study among 54 community-dwelling stroke patients from 4 villages. Of 54 participants, 51 (response rate: 94.4%) completed the feedback survey after receiving daily messages for 3 months. Participants' mean age was 68 years (SD 9.2), and about half had never been to school. We observed a higher proportion of participants who were in favor of voice messages (23/42, 54%) than text messages (14/40, 35%). Among participants who received voice messages (n=43) and text messages (n=40), 41 and 30, respectively, self-reported a full or partial understanding of the contents, and 39 (39/43, 91%) and 32 (32/40, 80%), respectively, rated the messages as helpful. Analyses of the 32 interviews further revealed that voice messages containing simple and single-theme content, in plain language, with a repeated structure, a slow playback speed, and recorded in local dialect, were preferred by rural stroke patients. In addition, the dispatching algorithm and tools may also influence the acceptance of message-based interventions.
CONCLUSIONS


By applying multiple methodologies and conducting a pilot study, we designed and fine-tuned a voice message-based intervention package for promoting secondary prevention among community-dwelling stroke patients in rural China. Design of the content and dispatching algorithm should engage both experts and end users and adequately consider the needs and preferences of recipients.",2019,"Among participants who received voice messages (n=43) and text messages (n=40), 41 and 30, respectively, self-reported a full or partial understanding of the contents, and 39 (39/43, 91%) and 32 (32/40, 80%), respectively, rated the messages as helpful.","['54 community-dwelling stroke patients from 4 villages', 'Nanhe County, Hebei Province, China', 'Stroke patients in rural communities', 'stroke patients in resource-poor settings in China', 'community-dwelling stroke patients in rural China', ""Participants' mean age was 68 years (SD 9.2), and about half had never been to school"", 'rural stroke patients', 'Community-Dwelling Stroke Patients in Rural China', 'A total of 4 villages']","['Mobile Health Messages', 'voice messages', 'caregivers to identify their needs; (3) drafting message contents and designing dispatching algorithms for a 3-month pilot testing; (4) collecting feedback from pilot participants through questionnaire survey and in-depth interviews on facilitators and barriers related to their acceptance and understanding of messages; and (5) finalizing the message-based intervention', 'fine-tuned a voice message-based intervention package']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1547277', 'cui_str': 'Draft'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]",[],4.0,0.104659,"Among participants who received voice messages (n=43) and text messages (n=40), 41 and 30, respectively, self-reported a full or partial understanding of the contents, and 39 (39/43, 91%) and 32 (32/40, 80%), respectively, rated the messages as helpful.","[{'ForeName': 'Enying', 'Initials': 'E', 'LastName': 'Gong', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Wanbing', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Erdan', 'Initials': 'E', 'LastName': 'Luo', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'Northumbria Healthcare National Health Service Foundation Trust, Wallsend, United Kingdom.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Longkai', 'Initials': 'L', 'LastName': 'Zang', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Bao', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Lijing L', 'Initials': 'LL', 'LastName': 'Yan', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, China.'}]",JMIR mHealth and uHealth,['10.2196/15758']
2661,32933009,Modifications of Gut Microbiota after Grape Pomace Supplementation in Subjects at Cardiometabolic Risk: A Randomized Cross-Over Controlled Clinical Trial.,"Polyphenols are dietary bioactive compounds able to induce modifications in the gut microbiota profile, although more clinical studies are needed. With this aim, a randomized cross-over clinical trial was conducted, where 49 subjects at cardiometabolic risk (exhibiting at least two metabolic syndrome factors) were supplemented with a daily dose of 8 g of grape pomace (GP) for 6 weeks, with an equivalent control (CTL) period. The levels of total bacteria and Bacteroidetes, Firmicutes, Lactobacilliales,  Bacteroides  and  Prevotella  were estimated in fecal DNA by quantitative real-time PCR (qPCR), while fecal short-chain fatty acids (SCFAs) were assessed by gas chromatography. Several cardiometabolic markers were evaluated in blood samples. GP reduced insulin levels only in half of the participants (responders). GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects. The reduction of insulin levels in subjects at cardiometabolic risk upon GP supplementation appears not to be induced by changes in the major subgroups of gut microbiota. Further studies at the species level may help to elucidate the possible role of microbiota in GP-induced insulinemic status.",2020,"GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects.","['subjects at cardiometabolic risk upon', '49 subjects at cardiometabolic risk (exhibiting at least two metabolic syndrome factors', 'Subjects at Cardiometabolic Risk']","['GP supplementation', 'Gut Microbiota after Grape Pomace Supplementation']","['GP reduced insulin levels', 'levels of total bacteria and Bacteroidetes, Firmicutes, Lactobacilliales,  Bacteroides  and  Prevotella  were estimated in fecal DNA by quantitative real-time PCR (qPCR), while fecal short-chain fatty acids (SCFAs', 'microbiota profile', 'proportion of Lactobacilliales', 'insulin levels']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",,0.0244715,"GP supplementation did not cause significant modifications in the microbiota profile of the whole group, except for a tendency ( p  = 0.059) towards a decrease in the proportion of Lactobacilliales, while it increased the proportion of  Bacteroides  in non-responder subjects.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ramos-Romero', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martínez-Maqueda', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), José Antonio Novais 10, 28040 Madrid, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Hereu', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Amézqueta', 'Affiliation': ""Departament d'Enginyeria Química i Química Analítica, Institut de Biomedicina (IBUB), Universitat de Barcelona, Carrer de Martí i Franquès, 1-11, 08028 Barcelona, Spain.""}, {'ForeName': 'Josep Lluís', 'Initials': 'JL', 'LastName': 'Torres', 'Affiliation': 'Institute of Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, 08034 Barcelona, Spain.'}, {'ForeName': 'Jara', 'Initials': 'J', 'LastName': 'Pérez-Jiménez', 'Affiliation': 'Department of Metabolism and Nutrition, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), José Antonio Novais 10, 28040 Madrid, Spain.'}]","Foods (Basel, Switzerland)",['10.3390/foods9091279']
2662,32933029,Longitudinal Evaluation of Working Memory in Duchenne Muscular Dystrophy.,"Objective:  The developmental maturation of forward and backward digit spans-indices of working memory-in boys with nonsense (nm) Duchenne muscular dystrophy (DMD) (nmDMD) was assessed using prospective, longitudinal data. Methods: Fifty-five boys of the 57 subjects with genetically confirmed nmDMD-who were from the placebo arm of a 48-week-long phase 2b clinical trial-were evaluated. Forward and backward digit spans were obtained every 12 weeks for a total of five assessments in all study subjects. Changes in forward and backward digit spans were evaluated based on age, corticosteroid treatment, and DMD mutation location.  Results:  Boys with nmDMD had lower mean scores on normalized forward digit span. Normalized forward digit spans were comparable between subjects stratified by age and between corticosteroid-naïve and corticosteroid-treated subjects. When stratified by DMD mutation location, normalized forward digit spans were lower in nmDMD subjects with mutations downstream of DMD exon 30, exon 45, and exon 63, both at baseline evaluation and at follow-up evaluation at 48 weeks. On average, normalized backward digit span scores were stable over 48 weeks in these subjects. Developmental growth modeling showed that subjects with nmDMD mutations upstream of DMD exon 30, upstream of DMD exon 45, and upstream of DMD exon 63 appeared to make better gains in working memory than subjects with mutations downstream of DMD exon 30, downstream of DMD exon 45, and downstream of DMD exon 63.  Conclusion:  Performance in working memory shows deficits in nmDMD and differed based on nmDMD location. Maturation in cognition was seen over a 48-week period. The developmental trajectory of working memory in this cohort was influenced by  DMD  mutation location.",2020,"exon 63 appeared to make better gains in working memory than subjects with mutations downstream of DMD exon 30, downstream of DMD exon 45, and downstream of DMD exon 63.  ","['Methods: Fifty-five boys of the 57 subjects with genetically confirmed nmDMD-who were from the placebo arm of a 48-week-long phase 2b clinical trial-were evaluated', 'Duchenne Muscular Dystrophy', 'nmDMD subjects with mutations downstream of DMD', 'subjects with nmDMD mutations upstream of DMD exon 30, upstream of DMD exon 45, and upstream of DMD', 'boys with nonsense (nm) Duchenne muscular dystrophy (DMD) (nmDMD']",[],"['working memory', 'normalized forward digit span', 'Normalized forward digit spans', 'normalized backward digit span scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0544885', 'cui_str': 'Nonsense mutation'}]",[],"[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",57.0,0.0329416,"exon 63 appeared to make better gains in working memory than subjects with mutations downstream of DMD exon 30, downstream of DMD exon 45, and downstream of DMD exon 63.  ","[{'ForeName': 'Mathula', 'Initials': 'M', 'LastName': 'Thangarajh', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, 1101 East Marshall Street, P.O. Box 980599, Richmond, VA 23298, USA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Elfring', 'Affiliation': 'PTC Therapeutics Inc., South Plainfield, NJ 07080, USA.'}, {'ForeName': 'Panayiota', 'Initials': 'P', 'LastName': 'Trifillis', 'Affiliation': 'PTC Therapeutics Inc., South Plainfield, NJ 07080, USA.'}]",Journal of clinical medicine,['10.3390/jcm9092940']
2663,32933119,Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults.,"This study examined the effects of a person-centered nursing intervention program for frailty (PNIF) targeting community-dwelling prefrail older people in South Korea. The study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index. The intervention group ( n  = 20) received group intervention sessions two days/week for twelve weeks and the control group ( n  = 20) attended lectures about frailty prevention one day/week for four weeks. The evaluation instruments included the CHS Frailty Index, a JAMAR ®  hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS). Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks. No significant between-group differences in ESSI scores were observed. The PNIF effectively improved grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty among community-dwelling older adults.",2020,"Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks.","['study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index', 'Prefrail Community-Dwelling Older Adults', 'frailty (PNIF) targeting community-dwelling prefrail older people in South Korea']","['Person-Centered Nursing Intervention', 'control group ( n  = 20) attended lectures about frailty prevention', 'person-centered nursing intervention program']","['grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty', 'SPPB', 'ESSI scores', 'right-hand grip strength', 'K-CHAMPS', 'CHS Frailty Index, a JAMAR ®  hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS', 'CHS Frailty Index', 'left-hand grip strength']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",40.0,0.0117517,"Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks.","[{'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Ha', 'Affiliation': 'College of Nursing, Konyang University, Daejeon 35365, Korea.'}, {'ForeName': 'Yeon-Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Seoul National University, Seoul 03080, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186660']
2664,32933124,Are Respiratory Responses to Cold Air Exercise Different in Females Compared to Males? Implications for Exercise in Cold Air Environments.,"Research has shown that cold air exercise causes significant respiratory dysfunction, especially in female athletes. However, how female and male athletes respond to cold air exercise is not known. Thus, we aimed to compare acute respiratory responses (function, recovery and symptoms) in males and females after high-intensity cold air exercise. Eighteen (nine female) athletes completed two environmental chamber running trials at 0 °C and -20 °C (humidity 34 ± 5%) on different days in a randomized starting order. Spirometry was performed pre, 3, 6, 10, 15 and 20 min post. Respiratory symptoms were measured posttrial and heart rate and rating of perceived exertion were assessed during each trial. No significant differences in delta change (pre to post) were found at either temperature between sexes for FEV 1 , FVC, FEF50% and FEF25-75%. At -20 °C, FEV 1  decreased similarly in both sexes (males: 7.5%, females: 6.3%) but not at 0 °C,  p  = 0.003. Postexertion respiratory function recovery and reported symptoms were not different between sexes at either temperature. These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise. However, intense exercise at -20 °C is challenging to the respiratory system in both sexes and may lead to altered respiratory responses compared to mild winter conditions like 0 °C.",2020,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","['Eighteen (nine female) athletes completed two environmental chamber running trials at 0', 'males and females after high-intensity cold air exercise', 'female and male athletes', 'female athletes']",['cold air exercise'],"['acute respiratory responses (function, recovery and symptoms) to cold air exercise', 'delta change', 'acute respiratory responses (function, recovery and symptoms', 'posttrial and heart rate and rating of perceived exertion']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004179', 'cui_str': 'Atmosphere Exposure Chambers'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0448314,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kennedy', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, AB T6G 2H9, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lenz', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Faulhaber', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph17186662']
2665,32933153,Krill Oil Has Different Effects on the Plasma Lipidome Compared with Fish Oil Following 30 Days of Supplementation in Healthy Women: A Randomized Controlled and Crossover Study.,"This is a follow-up of our previous postprandial study and it focused on the plasma lipidomic responses to 30 days of krill oil (KO) versus fish oil (FO) supplementations in healthy women. Eleven women (aged 18-50 years) consumed KO or FO for 30 days in a randomized, cross-over study, with at least a four-week washout period between supplementations. The daily supplements provided 1.27 g/day of long-chain (LC) omega-3 polyunsaturated fatty acids (PUFA) from KO (containing 0.76 g eicosapentaenoic acid (EPA), 0.42 g docosahexaenoic acid (DHA)) and 1.44 g/day from FO (containing 0.79 g EPA, 0.47 g DHA). Fasting plasma samples at days 0, 15, and 30 were analyzed using gas chromatography and liquid chromatography electrospray ionisation-tandem mass spectrometry. KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days. Lipidomic analysis showed that 26 of 43 lipid molecular species had a significantly greater relAUC in the KO group, while 17/43 showed a significantly lower relAUC compared with the FO group. More than 38% of the lipids species which increased more following KO contained omega-3 PUFA, while where FO was greater than KO, only 12% contained omega-3 PUFA. These data show that KO and FO do not have equivalent effects on the plasma lipidome.",2020,KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days.,"['Eleven women (aged 18-50 years', 'healthy women', 'Healthy Women']","['long-chain (LC) omega-3 polyunsaturated fatty acids (PUFA) from KO (containing 0.76 g eicosapentaenoic acid (EPA), 0.42 g docosahexaenoic acid (DHA', 'Krill Oil', 'consumed KO or FO', 'krill oil (KO) versus fish oil (FO) supplementations', 'Fish Oil']","['relative area under the curve (relAUC) for plasma EPA', 'Fasting plasma samples', 'relAUC', 'Plasma Lipidome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C4517458', 'cui_str': '0.42'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C4727084', 'cui_str': 'Lipidome'}]",,0.0997975,KO resulted in a significantly greater relative area under the curve (relAUC) for plasma EPA after 30 days.,"[{'ForeName': 'Hyunsin H', 'Initials': 'HH', 'LastName': 'Sung', 'Affiliation': 'Institute for Health and Sport, Victoria University, P.O. Box 14428, Melbourne, VIC 8001, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, VIC 3217, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Huynh', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Adam A T', 'Initials': 'AAT', 'LastName': 'Smith', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Mellett', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Meikle', 'Affiliation': 'Metabolomics Laboratory, Baker Heart and Diabetes Institute, Melbourne, VIC 3004, Australia.'}, {'ForeName': 'Xiao Q', 'Initials': 'XQ', 'LastName': 'Su', 'Affiliation': 'Institute for Health and Sport, Victoria University, P.O. Box 14428, Melbourne, VIC 8001, Australia.'}]",Nutrients,['10.3390/nu12092804']
2666,32933332,"TNFα  G308A genotype, resilience to sleep deprivation, and the effect of caffeine on psychomotor vigilance performance in a randomized, double-blind, placebo-controlled, crossover study.","The  TNFα  G308A gene polymorphism has been reported to influence performance impairment during total sleep deprivation (TSD). We investigated this effect in a randomized, double-blind, crossover laboratory study of repeated exposure to 48 h TSD with caffeine administration at different doses. In a retrospective analysis, we replicated the finding that the A allele of  TNFα  G308A, found in 4 of 12 study participants, confers resilience to performance impairment during TSD. There was no evidence of an interaction of  TNFα  genotype with the beneficial effect of caffeine (200 or 300 mg) on performance during TSD, suggesting distinct underlying mechanisms.",2020,"There was no evidence of an interaction of  TNFα  genotype with the beneficial effect of caffeine (200 or 300 mg) on performance during TSD, suggesting distinct underlying mechanisms.",[],"['caffeine', 'placebo']",['psychomotor vigilance performance'],[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043012', 'cui_str': 'Wakefulness'}]",,0.478961,"There was no evidence of an interaction of  TNFα  genotype with the beneficial effect of caffeine (200 or 300 mg) on performance during TSD, suggesting distinct underlying mechanisms.","[{'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Skeiky', 'Affiliation': 'Sleep and Performance Research Center, Washington State University , Spokane, WA, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Brager', 'Affiliation': 'Sleep Research Center, Behavioral Biology Branch, Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research , Silver Spring, MD, USA.'}, {'ForeName': 'Brieann C', 'Initials': 'BC', 'LastName': 'Satterfield', 'Affiliation': 'Sleep and Performance Research Center, Washington State University , Spokane, WA, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Petrovick', 'Affiliation': 'Group 49 - Biological and Chemical Technologies, MIT Lincoln Labs , Lexington, MA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Balkin', 'Affiliation': 'Sleep Research Center, Behavioral Biology Branch, Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research , Silver Spring, MD, USA.'}, {'ForeName': 'Vincent F', 'Initials': 'VF', 'LastName': 'Capaldi', 'Affiliation': 'Sleep Research Center, Behavioral Biology Branch, Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research , Silver Spring, MD, USA.'}, {'ForeName': 'Ruthie H', 'Initials': 'RH', 'LastName': 'Ratcliffe', 'Affiliation': 'Sleep Research Center, Behavioral Biology Branch, Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research , Silver Spring, MD, USA.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University , Spokane, WA, USA.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University , Spokane, WA, USA.'}]",Chronobiology international,['10.1080/07420528.2020.1821044']
2667,32933339,Empirical power comparison of statistical tests in contemporary phase III randomized controlled trials with time-to-event outcomes in oncology.,"BACKGROUND


More than 95% of recent cancer randomized controlled trials used the log-rank test to detect a treatment difference making it the predominant tool for comparing two survival functions. As with other tests, the log-rank test has both advantages and disadvantages. One advantage is that it offers the highest power against proportional hazards differences, which may be a major reason why alternative methods have rarely been employed in practice. The performance of statistical tests has traditionally been investigated both theoretically and numerically for several patterns of difference between two survival functions. However, to the best of our knowledge, there has been no attempt to compare the performance of various statistical tests using empirical data from past oncology randomized controlled trials. So, it is unknown whether the log-rank test offers a meaningful power advantage over alternative testing methods in contemporary cancer randomized controlled trials. Focusing on recently reported phase III cancer randomized controlled trials, we assessed whether the log-rank test gave meaningfully greater power when compared with five alternative testing methods: generalized Wilcoxon, test based on maximum of test statistics from multiple weighted log-rank tests, difference in  t -year event rate, and difference in restricted mean survival time with fixed and adaptive  τ .
METHODS


Using manuscripts from cancer randomized controlled trials recently published in high-tier clinical journals, we reconstructed patient-level data for overall survival (69 trials) and progression-free survival (54 trials). For each trial endpoint, we estimated the empirical power of each test. Empirical power was measured as the proportion of trials for which a test would have identified a significant result ( p  value < .05).
RESULTS


For overall survival,  t -year event rate offered the lowest (30.4%) empirical power and restricted mean survival time with fixed  τ  offered the highest (43.5%). The empirical power of the other types of tests was almost identical (36.2%-37.7%). For progression-free survival, the tests we investigated offered numerically equivalent empirical power (55.6%-61.1%). No single test consistently outperformed any other test.
CONCLUSION


The empirical power assessment with the past cancer randomized controlled trials provided new insights on the performance of statistical tests. Although the log-rank test has been used in almost all trials, our study suggests that the log-rank test is not the only option from an empirical power perspective. Near universal use of the log-rank test is not supported by a meaningful difference in empirical power. Clinical trial investigators could consider alternative methods, beyond the log-rank test, for their primary analysis when designing a cancer randomized controlled trial. Factors other than power (e.g. interpretability of the estimated treatment effect) should garner greater consideration when selecting statistical tests for cancer randomized controlled trials.",2020,The empirical power of the other types of tests was almost identical (36.2%-37.7%).,"['Using manuscripts from cancer randomized controlled trials recently published in high-tier clinical journals, we reconstructed patient-level data for overall survival (69 trials) and progression-free survival (54 trials']",[],"['mean survival time', 'mean survival time with fixed and adaptive  τ ', 'overall survival']","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",[],"[{'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.282187,The empirical power of the other types of tests was almost identical (36.2%-37.7%).,"[{'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Horiguchi', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hassett', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520940256']
2668,32933342,Use of electronic recruitment methods in a clinical trial of adults with gout.,"BACKGROUND/AIMS


Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods.
METHODS


We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)-like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record-based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method.
RESULTS


Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods. Patient portal messaging, an electronic medical record-based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans.
CONCLUSION


An electronic medical record-based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.",2020,Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107).,"['women and African Americans', 'adults with gout', '294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods']",['dietary approaches to stop hypertension (DASH)-like diet'],"['response rate, screening visit completion rate, and randomization rate', 'screening visit completion rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",294.0,0.25622,Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107).,"[{'ForeName': 'Hailey N', 'Initials': 'HN', 'LastName': 'Miller', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Beiwen', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gleason', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison Himmelfarb', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Ford', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine, The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'Gelber', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520956969']
2669,32933346,Post-marketing surveillance of high-dose methotrexate (>8 mg/week) in Japanese patients with rheumatoid arthritis: A post-hoc sub-analysis of patients according to duration of prior methotrexate use.,"Objectives:  To explore whether the duration of prior low-dose methotrexate treatment (MTX; ≤8 mg/week) influences the safety and effectiveness of high-dose MTX (>8 mg/week) in Japanese patients with rheumatoid arthritis (RA). Methods:  This post-hoc sub-analysis of a Japanese post-marketing surveillance study evaluated patients initiating high-dose MTX with ≥1 year or <1 year prior low-dose MTX use. Over 24 or 52 weeks, adverse drug reactions (ADRs) were monitored, and effectiveness was assessed using the Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]). Results:  1292 MTX ≥1 year and 1001 MTX <1 year patients were included. The incidence of ADRs during the 24- and 52-week follow-up period was significantly more frequent in MTX <1 year than ≥1 year patients and serious ADRs were significantly higher in MTX <1 year than ≥1 year patients during the 52-week follow-up period (all p < 0.05). Over both follow-up periods, the mean DAS28-4(ESR) significantly decreased from baseline for all groups. Remission and low disease activity rates (DAS28-4[ESR] < 2.6 and <3.2, respectively) increased from baseline for all groups. Conclusions:  High-dose MTX reduced disease activity regardless of prior treatment duration, but ADRs occurred more frequently among MTX <1 year patients compared to MTX ≥1 year patients.",2020,"Over both follow-up periods, the mean DAS28-4(ESR) significantly decreased from baseline for all groups.","['Japanese patients with rheumatoid arthritis', 'Japanese patients with rheumatoid arthritis (RA', 'patients initiating high-dose MTX with ≥1 year or <1 year prior low-dose MTX use']","['methotrexate', 'MTX', 'methotrexate treatment (MTX']","['disease activity', 'mean DAS28-4(ESR', 'adverse drug reactions (ADRs', 'Remission and low disease activity rates', 'Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR', 'incidence of ADRs', 'safety and effectiveness', 'serious ADRs']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0340984,"Over both follow-up periods, the mean DAS28-4(ESR) significantly decreased from baseline for all groups.","[{'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Tokai University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Atopy (Allergy) Research Center, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sugiyama', 'Affiliation': 'Clinical Statistics, Biometrics and Data Management, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Post-Marketing Study Strategy and Management, Development Japan, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Campos-Alberto', 'Affiliation': 'Immunology & Inflammation Medical Affairs, Pfizer Innovative Health, Pfizer Japan Inc, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1823604']
2670,32933348,"Group-based Compassion-focused Therapy on Experiential Avoidance, Meaning-in-life, and Sense of Coherence in Female Survivors of Intimate Partner Violence with PTSD: A Randomized Controlled Trial.","The current study was carried out to investigate the effects of compassion-focused therapy (CFT) on experiential avoidance, meaning-in-life, and sense of coherence (SoC) in women suffering from post-traumatic stress disorder (PTSD) due to the intimate partner violence (IPV).42 women suffering from PTSD due to the IPV exposure were randomized to the two groups of experimental and control (21 per group). All participants completed the questionnaires of experiential avoidance, meaning-in-life, and SoC as pre-test measures. The experimental group received eight sessions of CFT, while the controls did not receive any treatment. After that, all subjects responded to the questionnaires of experiential avoidance, meaning-in-life, and SoC as the post-test measures. Data were analyzed using one-way repeated measures MANOVA.Subjects of the experimental group indicated a greater reduction in post-test scores of experiential avoidance, and a significant rise in the level of meaning-in-life and its subscales including the presence of meaning-in-life and search for meaning-in-life when compared to the controls. Nevertheless, there was no change in the level of SoC as a function of CFT.Applying CFT can result in reducing experiential avoidance and raising the meaning of life in women with PTSD due to IPV exposure. CFT is highly recommended to strengthen the well-being of patients with PTSD and reduce the PTSD symptoms.",2020,"Data were analyzed using one-way repeated measures MANOVA.Subjects of the experimental group indicated a greater reduction in post-test scores of experiential avoidance, and a significant rise in the level of meaning-in-life and its subscales including the presence of meaning-in-life and search for meaning-in-life when compared to the controls.","['women with PTSD due to IPV exposure', 'Female Survivors of Intimate Partner Violence with PTSD', 'women suffering from post-traumatic stress disorder (PTSD) due to the intimate partner violence (IPV).42 women suffering from PTSD due to the IPV exposure']","['Compassion-focused Therapy on Experiential Avoidance, Meaning-in-life, and Sense of Coherence', 'CFT', 'compassion-focused therapy (CFT']","['experiential avoidance, meaning-in-life, and sense of coherence (SoC', 'level of meaning-in-life and its subscales including the presence of meaning-in-life and search for meaning-in-life', 'experiential avoidance', 'questionnaires of experiential avoidance, meaning-in-life, and SoC as pre-test measures', 'post-test scores of experiential avoidance', 'questionnaires of experiential avoidance, meaning-in-life, and SoC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0190063,"Data were analyzed using one-way repeated measures MANOVA.Subjects of the experimental group indicated a greater reduction in post-test scores of experiential avoidance, and a significant rise in the level of meaning-in-life and its subscales including the presence of meaning-in-life and search for meaning-in-life when compared to the controls.","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Daneshvar', 'Affiliation': 'Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Shafiei', 'Affiliation': 'Lorestan University, Khurramabad, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'University of Mohaghegh Ardabili, Ardabil, Iran.'}]",Journal of interpersonal violence,['10.1177/0886260520958660']
2671,32933356,"The impact of myo-inositol supplementation on sleep quality in pregnant women: a randomized, double-blind, placebo-controlled study.","BACKGROUND


Myo-inositol, a glial marker which plays a critical role in some brain regions, can supposedly affect sleep processes. The purpose of randomized controlled trial was to evaluate the impact of myo-inositol supplementation on sleep quality of pregnant women.
METHODS


The study enrolled 60 women with low risk singleton pregnancies, with a gestational age of at least 14 weeks, in Iran. The participants were block randomized to receive myo-inositol supplementation powder containing 2000 mg of myo-inositol and 200 μg of folic acid or placebo (400 μg of folic acid) for 10 weeks from the gestational age of 14-24. Sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was the change in sleep quality from the first trimester to the second trimester (24-28 weeks). The ANCOVA with adjusted covariate variables in the first trimester was conducted to estimate the sleep quality between the two groups.
RESULTS


The results of ANCOVA boot strapped showed that the mean difference of the total sleep quality score between the two groups was -1.537; 95% CI: -3.050 to -0.024,  p  = .047) in the second trimester at immediately post-intervention. Also, there were significant differences between the two groups in terms of subjective sleep quality (MD: -0.427; 95% CI: -0.725 to -0.128,  p  = .006, sleep duration (MD: -0.670; 95% CI: -1.240 to -0.101;  p  = .022) and habitual sleep efficiency (MD: -0.561; 95% CI: -1.038 to -0.085,  p  = .022).
CONCLUSION


The research confirmed that myo-inositol supplementation can improve global sleep quality, subjective sleep quality, and sleep duration during pregnancy. Therefore, these findings applied to minimize the rate of poor sleep quality in pregnant women.",2020,"Also, there were significant differences between the two groups in terms of subjective sleep quality (MD: -0.427; 95% CI: -0.725 to -0.128,  p  = .006, sleep duration (MD:","['pregnant women', '60 women with low risk singleton pregnancies, with a gestational age of at least 14\u2009weeks, in Iran']","['myo-inositol supplementation', 'placebo', 'myo-inositol supplementation powder containing 2000\u2009mg of myo-inositol and 200\u2009μg of folic acid or placebo (400\u2009μg of folic acid']","['Pittsburgh Sleep Quality Index (PSQI', 'subjective sleep quality', 'sleep duration (MD', 'global sleep quality, subjective sleep quality, and sleep duration', 'change in sleep quality', 'habitual sleep efficiency', 'total sleep quality score', 'Sleep quality', 'sleep quality']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.216162,"Also, there were significant differences between the two groups in terms of subjective sleep quality (MD: -0.427; 95% CI: -0.725 to -0.128,  p  = .006, sleep duration (MD:","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Mashayekh-Amiri', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mouloud Agajani', 'Initials': 'MA', 'LastName': 'Delavar', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bakouei', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1818225']
2672,32933470,A randomized controlled trial evaluating the hemodynamic impact of ultrasound-guided great auricular nerve block in middle ear microsurgery.,"BACKGROUND


The peri-operative effectiveness of ultrasound-guided great auricular nerve block (GANB) in patients, especially in adult patients undergoing middle ear microsurgery remains unclear. We hypothesized that ultrasound-guided GANB would decrease the hemodynamic responsiveness to incision and opioid consumption in middle ear microsurgery as well as the post-operative analgesia requirement.
METHODS


Sixty patients undergoing middle ear microsurgery were randomized into two equal groups to receive either a GANB with 2 ml of 0.25% ropivacaine under ultrasound guidance (GANB group) or to receive a blank control intervention (without any performed injection) before general anesthesia inductions. The primary outcomes were hemodynamic changes of MAP (mean artery pressure) and HR (heart rate) to skin incision. The secondary endpoints were to determine the consumptions of propofol and remifentanil during the operation and the incidence of remedial analgesia 48 h post-operation to maintain VAS ≤ 3.
RESULTS


The MAP post incision in GANB group was significantly lower than that in control group (GANB group 93.83 ± 11.72 mmHg vs. control group 100.87 ± 12.65 mmHg, P = 0.029). The increases for MAP and HR post incision were also lower in GANB group (∆MAP GANB group 11.90 ± 8.32 mmHg vs. control group 19.83 ± 10.37 mmHg, P = 0.002; ∆HR GANB group 3.67 ± 5.30 beat min - 1  vs. control group 8.23 ± 8.56 beat min - 1 , P = 0.016). Remifentanil consumption was significantly decreased in GANB group (GANB group 401.55 ± 100.51 μg h - 1  vs. control group 697.34 ± 215.45 μg h - 1 , P = 0.000). The incidence of remedial analgesia post-operation in GANB group (5/30) was significantly lower than that in control group (20/30, P = 0.000).
CONCLUSION


Ultrasound-guided GANB decreases the hemodynamic responsiveness to incision and remifentanil consumption in middle ear microsurgery as well as the post-operative analgesia requirement.
TRIAL REGISTRATION


This trial was retrospectively registered at http://www.chictr.org.cn with the registration number of ChiCTR1800014333 on 6 January, 2018.",2020,"Remifentanil consumption was significantly decreased in GANB group (GANB group 401.55 ± 100.51 μg h - 1  vs. control group 697.34 ± 215.45 μg h - 1 , P = 0.000).","['adult patients undergoing middle ear microsurgery', 'middle ear microsurgery', 'Sixty patients undergoing middle ear microsurgery']","['ultrasound-guided great auricular nerve block (GANB', 'ultrasound-guided GANB', 'ultrasound-guided great auricular nerve block', 'Ultrasound-guided GANB', 'GANB with 2\u2009ml of 0.25% ropivacaine under ultrasound guidance (GANB group) or to receive a blank control intervention (without any performed injection']","['Remifentanil consumption', 'incidence of remedial analgesia post-operation', 'hemodynamic changes of MAP (mean artery pressure) and HR (heart rate) to skin incision', 'consumptions of propofol and remifentanil during the operation and the incidence of remedial analgesia 48\u2009h post-operation to maintain VAS\u2009≤\u20093', 'hemodynamic responsiveness', 'MAP and HR post incision']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394694', 'cui_str': 'Local anesthetic greater auricular nerve block'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]",60.0,0.0705863,"Remifentanil consumption was significantly decreased in GANB group (GANB group 401.55 ± 100.51 μg h - 1  vs. control group 697.34 ± 215.45 μg h - 1 , P = 0.000).","[{'ForeName': 'Jinsheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kezhi', 'Initials': 'K', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongling', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Guyan', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tongren Hospital, Capital Medical University, Beijing, China. guyanwang2006@163.com.'}, {'ForeName': 'Tianzuo', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China. trmzltz888@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01155-y']
2673,32933489,Cost-effectiveness analysis of systematic fast-track transition from oncological treatment to specialised palliative care at home for patients and their caregivers: the DOMUS trial.,"BACKGROUND


While hospitals remain the most common place of death in many western countries, specialised palliative care (SPC) at home is an alternative to improve the quality of life for patients with incurable cancer. We evaluated the cost-effectiveness of a systematic fast-track transition process from oncological treatment to SPC enriched with a psychological intervention at home for patients with incurable cancer and their caregivers.
METHODS


A full economic evaluation with a time horizon of six months was performed from a societal perspective within a randomised controlled trial, the DOMUS trial ( Clinicaltrials.gov : NCT01885637). The primary outcome of the health economic analysis was a incremental cost-effectiveness ratio (ICER), which is obtained by comparing costs required per gain in Quality-Adjusted Life Years (QALY). The costs included primary and secondary healthcare costs, cost of intervention and informal care from caregivers. Public transfers were analysed in seperate analysis. QALYs were measured using EORTC QLQ-C30 for patients and SF-36 for caregivers. Bootstrap simulations were performed to obtain the ICER estimate.
RESULTS


In total, 321 patients (162 in intervention group, 159 in control group) and 235 caregivers (126 in intervention group, 109 in control group) completed the study. The intervention resulted in significantly higher QALYs for patients when compared to usual care (p-value = 0.026), while being more expensive as well. In the 6 months observation period, the average incremental cost of intervention compared to usual care was €2015 per patient (p value < 0.000). The mean incremental gain was 0.01678 QALY (p-value = 0.026). Thereby, the ICER was €118,292/QALY when adjusting for baseline costs and quality of life. For the caregivers, we found no significant differences in QALYs between the intervention and control group (p-value = 0.630). At a willingness to pay of €80,000 per QALY, the probability that the intervention is cost-effective lies at 15% in the base case scenario.
CONCLUSION


This model of fast-track SPC enriched with a psychological intervention yields better QALYs than usual care with a large increase in costs.
TRIAL REGISTRATION


The trial was prospectively registered 25.6.2013. Clinicaltrials.gov Identifier: NCT01885637 .",2020,"The intervention resulted in significantly higher QALYs for patients when compared to usual care (p-value = 0.026), while being more expensive as well.","['patients with incurable cancer and their caregivers', 'specialised palliative care at home for patients and their caregivers', 'patients with incurable cancer', '321 patients (162 in intervention group, 159 in control group) and 235 caregivers (126 in intervention group, 109 in control group) completed the study']","['systematic fast-track transition', 'psychological intervention']","['average incremental cost of intervention', 'cost-effectiveness', 'healthcare costs, cost of intervention and informal care from caregivers', 'incremental cost-effectiveness ratio (ICER), which is obtained by comparing costs required per gain in Quality-Adjusted Life Years (QALY', 'baseline costs and quality of life', 'QALYs', 'cost-effective lies', 'mean incremental gain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0303400', 'cui_str': 'Indium-109'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",321.0,0.13811,"The intervention resulted in significantly higher QALYs for patients when compared to usual care (p-value = 0.026), while being more expensive as well.","[{'ForeName': 'Christine Marie Bækø', 'Initials': 'CMB', 'LastName': 'Halling', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K, Denmark. chsk@vive.dk.'}, {'ForeName': 'Rasmus Trap', 'Initials': 'RT', 'LastName': 'Wolf', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjøgren', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Von Der Maase', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Timm', 'Affiliation': 'REHPA - The Danish Knowledge Centre for Rehabilitation and Palliative Care, Copenhagen, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Johansen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kjellberg', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K, Denmark.'}]",BMC palliative care,['10.1186/s12904-020-00645-7']
2674,32933498,"RACE-trial: neoadjuvant radiochemotherapy versus chemotherapy for patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction - a randomized phase III joint study of the AIO, ARO and DGAV.","BACKGROUND


Despite obvious advances over the last decades, locally advanced adenocarcinomas of the gastroesophageal junction (GEJ) still carry a dismal prognosis with overall 5-year survival rates of less than 50% even when using modern optimized treatment protocols such as perioperative chemotherapy based on the FLOT regimen or radiochemotherapy. Therefore the question remains whether neoadjuvant chemotherapy or neoadjuvant radiochemotherapy is eliciting the best results in patients with GEJ cancer. Hence, an adequately powered multicentre trial comparing both therapeutic strategies is clearly warranted.
METHODS


The RACE trial is a an investigator initiated multicenter, prospective, randomized, stratified phase III clinical trial and seeks to investigate the role of preoperative induction chemotherapy (2 cycles of FLOT: 5-FU, leucovorin, oxaliplatin, docetaxel) with subsequent preoperative radiochemotherapy (oxaliplatin weekly, 5-FU plus concurrent fractioned radiotherapy to a dose of 45 Gy) compared to preoperative chemotherapy alone (4 cycles of FLOT), both followed by resection and postoperative completion of chemotherapy (4 cycles of FLOT), in the treatment of locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction. Patients with cT3-4, any N, M0 or cT2 N+, M0 adenocarcinoma of the GEJ are eligible for inclusion. The RACE trial aims to enrol 340 patients to be allocated to both treatment arms in a 1:1 ratio stratified by tumour site. The primary endpoint of the trial is progression-free survival assessed with follow-up of maximum 60 months. Secondary endpoints include overall survival, R0 resection rate, number of harvested lymph nodes, site of tumour relapse, perioperative morbidity and mortality, safety and toxicity and quality of life.
DISCUSSION


The RACE trial compares induction chemotherapy with FLOT followed by preoperative oxaliplatin and 5-Fluorouracil-based chemoradiation versus preoperative chemotherapy with FLOT alone, both followed by surgery and postoperative completion of FLOT chemotherapy in the treatment of locally advanced, non-metastatic adenocarcinoma of the GEJ. The trial aims to show superiority of the combined chemotherapy/radiochemotherapy treatment, assessed by progression-free survival, over perioperative chemotherapy alone.
TRIAL REGISTRATION


ClinicalTrials.gov ; NCT04375605 ; Registered 4th May 2020.",2020,"Secondary endpoints include overall survival, R0 resection rate, number of harvested lymph nodes, site of tumour relapse, perioperative morbidity and mortality, safety and toxicity and quality of life.
","['340 patients', 'patients with locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction - a randomized phase III joint study of the AIO, ARO and DGAV', 'patients with GEJ cancer', 'locally advanced, potentially resectable adenocarcinoma of the gastroesophageal junction', 'Patients with cT3-4, any N, M0 or cT2 N+, M0 adenocarcinoma of the GEJ are eligible for inclusion']","['preoperative chemotherapy alone (4 cycles of FLOT), both followed by resection and postoperative completion of chemotherapy (4\u2009cycles of FLOT', 'FLOT chemotherapy', 'radiochemotherapy versus chemotherapy', 'FLOT regimen or radiochemotherapy', 'preoperative induction chemotherapy (2 cycles of FLOT: 5-FU, leucovorin, oxaliplatin, docetaxel) with subsequent preoperative radiochemotherapy (oxaliplatin weekly, 5-FU plus concurrent fractioned radiotherapy', 'neoadjuvant chemotherapy or neoadjuvant radiochemotherapy', 'combined chemotherapy/radiochemotherapy', 'oxaliplatin and 5-Fluorouracil-based chemoradiation versus preoperative chemotherapy with FLOT']","['progression-free survival', '5-year survival rates', 'overall survival, R0 resection rate, number of harvested lymph nodes, site of tumour relapse, perioperative morbidity and mortality, safety and toxicity and quality of life']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0475445', 'cui_str': 'Tumor site'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.154424,"Secondary endpoints include overall survival, R0 resection rate, number of harvested lymph nodes, site of tumour relapse, perioperative morbidity and mortality, safety and toxicity and quality of life.
","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Department of Internal Medicine III (Haematology/Medical Oncology), Technical University Munich, Ismaningerstr. 22, 81675, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Biederstädt', 'Affiliation': 'Department of Internal Medicine III (Haematology/Medical Oncology), Technical University Munich, Ismaningerstr. 22, 81675, Munich, Germany. alexander.biederstaedt@tum.de.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ronellenfitsch', 'Affiliation': 'Department of Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale), Halle (Saale), Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Reißfelder', 'Affiliation': 'Department of Surgery, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Mönig', 'Affiliation': 'Visceral Surgery Department, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Wenz', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pauligk', 'Affiliation': 'Institute of Clinical Cancer Research IKF at Northwest hospital, UCT University Cancer Center, Frankfurt am Main, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Institute of Clinical Cancer Research IKF at Northwest hospital, UCT University Cancer Center, Frankfurt am Main, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Institute of Clinical Cancer Research IKF at Northwest hospital, UCT University Cancer Center, Frankfurt am Main, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Institute for Medical Statistics and Epidemiology, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'Interdisciplinary Tumour Centre Mannheim, University Medicine of Mannheim, Mannheim, Germany.'}]",BMC cancer,['10.1186/s12885-020-07388-x']
2675,32933499,"The Sandwich principle: assessing the didactic effect in lectures on ""cleft lips and palates"".","BACKGROUND


A teaching concept, that takes individual learning and personal belongings into account, is called the ""sandwich principle."" This didactic method is an educational concept that alternates consecutively between individual and collective learning phases during a course. This study aimed to prove whether the application of the sandwich principle in lectures increases the learning outcome compared with classical lectures.
METHODS


All participants (n = 64) were randomly allocated into two groups. One group attended a classical face-to-face lecture and the other attended a lecture that was modified according to the sandwich principle, including activating elements. To compare knowledge gain after the lectures, all the participants had to answer a test comprising40 single-choice questions. In addition, the lectures were evaluated.
RESULTS


Students attending the sandwich lecture had significantly better scores in the test than those who attending the classical lecture (p <  0.001). The mean test score of the sandwich group was 63.9% [standard deviation (SD) = 10] points and of the control group 50.2% (SD = 13.7 points). Overall, both the class conditions showed good evaluation results; however, students of the sandwich lecture were more satisfied with the lecture format compared with the other group.
CONCLUSION


Our study results confirm the thesis that the application of the sandwich principle in lectures increases the learning outcome compared with classical lectures. Even with a big audience, the sandwich design presents a concept that helps maintain high attention levels and addresses individual learning styles.",2020,Our study results confirm the thesis that the application of the sandwich principle in lectures increases the learning outcome compared with classical lectures.,['All participants (n\u2009=\u200964'],[],"['mean test score', 'knowledge gain', 'learning outcome']",[],[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",64.0,0.0189702,Our study results confirm the thesis that the application of the sandwich principle in lectures increases the learning outcome compared with classical lectures.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bock', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074, Aachen, Germany. abock@ukaachen.de.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Idzko-Siekermann', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074, Aachen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lemos', 'Affiliation': 'Audiovisual Media Center, Medical Faculty, RWTH Aachen University, Pauwelsstraße 30, D-52074, Aachen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kniha', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074, Aachen, Germany.'}, {'ForeName': 'Stephan Christian', 'Initials': 'SC', 'LastName': 'Möhlhenrich', 'Affiliation': 'Department of Orthodontics, University Witten/Herdecke, Alfred-Herrhausen-Straße 44, D-58448, Witten, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Peters', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074, Aachen, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Modabber', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Pauwelsstrasse 30, D-52074, Aachen, Germany.'}]",BMC medical education,['10.1186/s12909-020-02209-y']
2676,32933504,"A randomized, double-blind, positive-controlled, prospective, dose-response clinical study to evaluate the efficacy and tolerability of an aqueous extract of Terminalia bellerica in lowering uric acid and creatinine levels in chronic kidney disease subjects with hyperuricemia.","BACKGROUND


Hyperuricemia is an independent risk factor in chronic kidney disease (CKD). Allopurinol and febuxostat are prescription medicines used to treat hyperuricemia but suffer side-effects. Earlier clinical study has shown that an aqueous extract of Terminalia bellerica (TBE), significantly reduced uric acid levels with no serious adverse effects in hyperuricemic subjects. The objective of this study is to determine the efficacy and tolerability of TB in reducing uric acid and creatinine levels in CKD subjects.
METHODS


59-subjects were randomized to three groups-40 mg-once-daily febuxostat, 500 mg-twice-daily and 1000 mg-twice-daily of TBE. Serum uric acid, creatinine levels and estimated-glometular-filtration-rate were measured at baseline, 4, 8, 12, 16, 20, 24-weeks. Biomarkers of oxidative-stress, endothelial function, systemic inflammation, and platelet-aggregation were evaluated at baseline, 4, 8, 12, 24-weeks. Adverse drug reactions were recorded. Statistical analysis evaluated using GraphPadPrism4.
RESULTS


55-subjects completed 24-week study. Starting at 4-weeks, all treatment groups showed a significant decrease in serum uric acid levels from baseline (p ≤ 0.0001). At 24-weeks, febuxostat, T.bellerica 500 mg-twice-daily, and T.bellerica 1000 mg-twice-daily doses decreased mean-percentage serum uric acid by 63.70 ± 4.62, 19.84 ± 6.43 and 33.88% ± 4.95% respectively (p ≤ 0.0001). Significant decrease in serum creatinine with all the groups starting at 16-weeks was seen (p ≤ 0.005-p ≤ 0.0001). At 24-weeks, the mean-percentage change in creatinine levels was 23.71 ± 12.50, 11.70 ± 9.0, and 24.42 ± 8.14, respectively with febuxostat, T.bellerica 500 mg-twice-daily and T.bellerica 1000 mg-twice-daily. Statistically significant (p ≤ 0.05) increase in estimated glomerular filtration rate-(eGFR) was seen at 20 (p ≤ 0.05) and 24-weeks (p ≤ 0.01) for both febuxostat vs T.bellerica 500 mg-twice-daily and T.bellerica 1000 mg-twice-daily vs T.bellerica 500 mg-twice-daily. There was no statistically significant difference between febuxostat and T.bellerica 1000 mg-twice-daily, with an increase of eGFR of 41.38 and 40.39 ml/min/1.73m 2  respectively, with the inference that T.bellerica at 1000 mg-twice-daily dose is as good as febuxostat 40 mg-once-daily. Positive improvements were made by all the groups in endothelial function and the related biomarkers and high-sensitivity C-reactive protein. None of the products showed effect on platelet aggregation.
CONCLUSION


In this 24-week study Febuxostat 40 mg, T. bellerica 500 mg-twice-daily and 1000 mg-twice-daily, significantly decreased the serum uric acid and creatinine levels, increased eGFR in CKD subjects. T. bellerica 500 mg-twice-daily and 1000 mg-twice-daily were one-third and more than half as effective at 24-weeks, respectively. T. bellerica extract may be considered a natural alternative for reducing serum uric acid levels.
TRIAL REGISTRATION


This study was registered with the Clinical Trials Registry - India (CTRI) with the registration number: CTRI/2019/11/022093 [Registered on: 21/11/2019] Trial Registered Retrospectively.",2020,Positive improvements were made by all the groups in endothelial function and the related biomarkers and high-sensitivity C-reactive protein.,"['CKD subjects', 'hyperuricemic subjects', '59-subjects', 'chronic kidney disease subjects with hyperuricemia', 'chronic kidney disease (CKD']","['Febuxostat', 'Allopurinol and febuxostat', 'groups-40\u2009mg-once-daily febuxostat, 500\u2009mg-twice-daily and 1000\u2009mg-twice-daily of TBE', 'aqueous extract of Terminalia bellerica', 'febuxostat', 'TB']","['oxidative-stress, endothelial function, systemic inflammation, and platelet-aggregation', 'serum uric acid levels', 'serum creatinine', 'platelet aggregation', 'uric acid and creatinine levels', 'mean-percentage change in creatinine levels', 'serum uric acid and creatinine levels', 'uric acid levels', 'Adverse drug reactions', 'efficacy and tolerability', 'estimated glomerular filtration rate-(eGFR', 'Serum uric acid, creatinine levels and\xa0estimated-glometular-filtration-rate']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0330871', 'cui_str': 'Terminalia'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}]",,0.144368,Positive improvements were made by all the groups in endothelial function and the related biomarkers and high-sensitivity C-reactive protein.,"[{'ForeName': 'Usharani', 'Initials': 'U', 'LastName': 'Pingali', 'Affiliation': ""Department of Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India. ushapingali@yahoo.com.""}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Nutalapati', 'Affiliation': ""Department of Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Koilagundla', 'Affiliation': ""Department of Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}, {'ForeName': 'Gangadhar', 'Initials': 'G', 'LastName': 'Taduri', 'Affiliation': ""Department of Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.""}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03071-7']
2677,32933510,"The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa.","BACKGROUND


Despite increased prevention efforts, HIV remains the leading cause of death among adolescent girls and young women in South Africa. Although research indicates important determinants of HIV acquisition at the individual and interpersonal levels, structural-level stigma and discrimination continue to be critical barriers to reaching and retaining this key population for HIV prevention and sexual and reproductive health services. Innovative and multilevel interventions are needed that can address the intersectional structural and gender issues that young women face, including stigma, alcohol and drug use, gender-based violence, and other risk factors when seeking health services. Oral pre-exposure prophylaxis (PrEP) taken daily has been found to be an effective biomedical HIV prevention tool. Testing a comprehensive gender-focused biobehavioral HIV prevention intervention that is inclusive of social ecological determinants, such as stigma and discrimination reduction in clinics, is critical for reducing HIV among adolescent girls and young women.
METHODS


This project involves both a Community Collaborative Board and a Youth Advisory Board in helping to adapt the Young Women's Health CoOp intervention and the Health Policy Project (HPP) Stigma and Discrimination (S&D) reduction training curriculum to the setting and population. This study uses a two-by-two factorial design with stratified randomization of 12 clinics, each with distinct catchment areas. The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health. Adolescent girls and young women will be assessed with behavioral and biological measures at baseline, 3-, 6- and 9-month follow-up. The S&D reduction training is provided for all staff in the clinics randomized to this condition. Clinic staff will be surveyed at baseline, 4- and 8-month follow-up. We will recruit 900 AGYW from communities in the 12 clinic catchment areas.
DISCUSSION


The study findings, if efficacious across the outcomes, will be incorporated into the gender-focused HIV prevention intervention toolkit and disseminated to inform multilevel prevention approaches.
TRIAL REGISTRATION


ClinicalTrials.gov. Identifier: NCT04048551 (Recruiting). Registered: August 7, 2019 (Retrospectively registered).",2020,"The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health.","['adolescent girls and young women in South Africa', '900 AGYW from communities in the 12 clinic catchment areas', '12 clinics, each with distinct catchment areas', 'adolescent girls and young women', 'Adolescent girls and young women', 'adolescent girls and young women in Tshwane, South Africa']","['biobehavioral HIV prevention intervention', 'HIV with PrEP', 'Oral pre-exposure prophylaxis (PrEP']",[],"[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",[],,0.0318294,"The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health.","[{'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. wmw@rti.org.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ndirangu', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Minnis', 'Affiliation': 'Center for Global Health, RTI International, 2150 Shattuck Avenue, Suite 800, Berkeley, CA, 94704, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nyblade', 'Affiliation': 'International Global Health Division, International Development Group, RTI International, 701 13th Street NW #750, Washington, DC, 20005, USA.'}, {'ForeName': 'Ilene S', 'Initials': 'IS', 'LastName': 'Speizer', 'Affiliation': 'Maternal and Child Health, University of North Carolina Gillings School of Global Public Health, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Brittni N', 'Initials': 'BN', 'LastName': 'Howard', 'Affiliation': 'Substance Use, Gender, and Applied Research Program, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol and Drug Abuse Research Unit, Medical Research Council Francie van Zijl Drive, Parow Valley, Cape Town, South Africa.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Centre, 2088 Block H, Soshanguve, 0152, South Africa.'}]",BMC public health,['10.1186/s12889-020-09458-y']
2678,32933552,Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients with confirmed COVID-19 that are moderately ill.
TRIAL DESIGN


This is a single-center, open-label, randomized, clinical trial with parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran.
PARTICIPANTS


Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria.
INCLUSION CRITERIA


1. Confirmed diagnosis of SARS-CoV-2 infection (via polymerase chain reaction [PCR] and/or antibody test). 2. Presenting as moderate COVID-19 pneumonia (via chest computed tomography (CT) and/or X-ray) requiring hospitalization. 3. Hospitalized ≤48 hours. 4. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm.
EXCLUSION CRITERIA


1. Underlying diseases, including chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs. 4. Treatment with Investigational and antiviral therapy in a clinical study within one month before randomization. 5. History of allergy to Licorice. 6. Pregnancy and breastfeeding.
INTERVENTION AND COMPARATOR


Intervention group: The standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran) at a dose of 760 mg three times a day for a period of seven days.
CONTROL GROUP


The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days.
MAIN OUTCOMES


The recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein, are evaluated as primary outcomes within seven days of randomization. Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization.
RANDOMIZATION


An electronic table of random numbers will be used to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the simple randomization method.
BLINDING (MASKING)


This is an open-label trial without blinding and placebo control.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group).
TRIAL STATUS


The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020.
TRIAL REGISTRATION


This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is ""IRCT20200506047323N2"", https://www.irct.ir/trial/47990 . The registration date is 31 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization.
","['Shahid Mohammadi Hospital, Bandar Abbas, Iran', 'patients with confirmed COVID-19 that are moderately ill', 'Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria', '60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group', 'moderately ill patients with pneumonia from COVID-19']","['warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs', 'placebo', 'Licorice (Glycyrrhiza glabra L.) root extract', 'Licorice', 'standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran', 'Investigational and antiviral therapy', 'GROUP']","['recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein', 'clinical symptoms and laboratory signs', 'Severe and critical COVID-19 pneumonia', 'chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0026457', 'cui_str': 'Monoamine oxidase inhibitor'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1290386', 'cui_str': 'Chronic heart disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}]",60.0,0.14235,"Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization.
","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassani-Azad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farashahinejad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Davoodian', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Dadvand', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04706-3']
2679,32933561,"Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial.","BACKGROUND


Cancer survivors experience compromised quality of life due to impaired cognitive function as a result of cancer diagnosis and treatment. Although exercise has proven to be effective in improving cognitive function across the lifespan, interventions comprehensively testing the effectiveness for cancer survivors are limited. The STAY Fit Trial is a three-armed pilot randomized controlled trial designed to compare the effects of a 12-week yoga, aerobic walking, and stretch and tone intervention on cognitive function among adult cancer survivors.
METHODS


This pilot study aims to recruit 75 adult cancer survivors who will complete assessments of cognitive function, cardiovascular fitness, physical activity, and psychosocial measures at baseline and after the 12-week intervention. The aims of STAY Fit are (1) to assess the efficacy of yoga to improve cognitive function among cancer survivors, compared to aerobic exercise and an active control group; (2) to examine changes in cardiovascular fitness as a result of the interventions; and (3) to assess changes in quality of life among our population as a result of the exercise interventions.
DISCUSSION


The STAY Fit Trial will test the effectiveness of yoga, aerobic exercise, and stretching and toning exercises in improving cognitive function and fitness among adult cancer survivors. The results of this pilot study will enable us to understand the most effective physical activity modality to improve cognitive function in this population and potentially combat cancer-related cognitive impairment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03650322 . Registered on 28 August 2018.",2020,"The aims of STAY Fit are (1) to assess the efficacy of yoga to improve cognitive function among cancer survivors, compared to aerobic exercise and an active control group; (2) to examine changes in cardiovascular fitness as a result of the interventions; and (3) to assess changes in quality of life among our population as a result of the exercise interventions.
","['adult cancer survivors', 'cancer survivors', '75 adult cancer survivors']","['yoga, aerobic walking, and stretch and tone intervention', 'aerobic exercise', 'yoga, aerobic exercise, and stretching and toning exercises', 'yoga, aerobic, and stretching and toning exercises']","['cognitive function, cardiovascular fitness, physical activity, and psychosocial measures', 'quality of life', 'cardiovascular fitness', 'cognitive function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",75.0,0.0866846,"The aims of STAY Fit are (1) to assess the efficacy of yoga to improve cognitive function among cancer survivors, compared to aerobic exercise and an active control group; (2) to examine changes in cardiovascular fitness as a result of the interventions; and (3) to assess changes in quality of life among our population as a result of the exercise interventions.
","[{'ForeName': 'Neha P', 'Initials': 'NP', 'LastName': 'Gothe', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, 61801, USA. npg@illinois.edu.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Erlenbach', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, 61801, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Streeter', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, 61801, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Lehovec', 'Affiliation': 'Department of Dance, University of Illinois at Urbana-Champaign, Urbana, 61801, USA.'}]",Trials,['10.1186/s13063-020-04723-2']
2680,32933571,The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion-study protocol for a randomized controlled trial.,"BACKGROUND


Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life.
METHODS


The study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient's self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery.
DISCUSSION


We hypothesize that, compared with the ""usual care group"", GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient's self-efficacy for exercise and quality of life.
TRIAL REGISTRATION


www.clinicaltrials.gov NCT04103970 , Registered on 24 September 2019.",2020,"The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life.
","['144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine', 'Patients with chronic low back pain undergoing lumbar spinal fusion (LSF', 'sedentary behaviour in a population of patients undergoing LSF']","['graded activity and pain education (GAPE', 'GAPE', 'usual care or usual care plus GAPE', 'early active intervention consisting of graded activity and pain education (GAPE']","['reduction in sedentary behaviour', 'disability, pain intensity, and fear of movement', 'disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life', 'disability, pain, fear of movement, self-efficacy for exercise, and quality of life']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",144.0,0.172449,"The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life.
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Tegner', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Valdemar Hansens Vej 13, 2600, Glostrup, Denmark. heidi.tegner@regionh.dk.'}, {'ForeName': 'Bente Appel', 'Initials': 'BA', 'LastName': 'Esbensen', 'Affiliation': 'Centre for Rheumatology and Spine Diseases, Rigshospitalet, Valdemar Hansens Vej 13, 2600, Glostrup, Denmark.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Henriksen', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital, Bispebjerg/Frederiksberg, Nordre Fasanvej 57, 2000, Frederiksberg, Denmark.'}, {'ForeName': 'Rachid', 'Initials': 'R', 'LastName': 'Bech-Azeddine', 'Affiliation': 'Centre for Rheumatology and Spine Diseases, Rigshospitalet, Valdemar Hansens Vej 13, 2600, Glostrup, Denmark.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Lundberg', 'Affiliation': 'Department of Health and Rehabilitation, University of Gothenburg, Box 455, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Nielsen', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Rigshospitalet, Valdemar Hansens Vej 13, 2600, Glostrup, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'DEFACTUM, Corporate Quality, Central Denmark Region, P.P. Oerumsgade 11, 8000, Aarhus C, Denmark.'}]",Trials,['10.1186/s13063-020-04719-y']
2681,32933575,Effect of using the WeChat platform on the perioperative health education of parents of children who underwent transthoracic device closure of VSDs.,"OBJECTIVE


To explore the effects of using the WeChat platform on the perioperative health education of parents of children who underwent transthoracic device closure of ventricular septal defects (VSDs).
METHODS


Participants were divided into a WeChat group and a leaflet group. Responses to relevant questionnaires and clinical data were recorded and analyzed.
RESULTS


Before the operation, the scores of the Caretaker Knowledge Questionnaire in the WeChat group were significantly higher than those in the leaflet group. The scores of PSQ-18 in the WeChat group were significantly higher than those in the leaflet group. All the children in the WeChat group were followed up 1 month after discharge, while four children in the leaflet group were lost to follow-up. The rate of attrition in the leaflet group was significantly higher than that in the WeChat group. For the postoperative complications, there was no significant difference between the two groups.
CONCLUSION


Perioperative health education for parents of children who undergo transthoracic device closure of VSDs through the WeChat platform can effectively enhance parents' knowledge of care, improve parent satisfaction, which is an effective method to ensure convenient operation and reduce loss to follow-up.",2020,The scores of PSQ-18 in the WeChat group were significantly higher than those in the leaflet group.,"['parents of children who underwent transthoracic device closure of ventricular septal defects (VSDs', 'parents of children who underwent transthoracic device closure of VSDs', 'Participants were divided into a WeChat group and a leaflet group']",['WeChat platform'],"['scores of the Caretaker Knowledge Questionnaire', 'scores of PSQ-18', 'rate of attrition']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0190023', 'cui_str': 'Closure of ventricular septal defect'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",,0.0201376,The scores of PSQ-18 in the WeChat group were significantly higher than those in the leaflet group.,"[{'ForeName': 'Qi-Liang', 'Initials': 'QL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. chenqiang2228@163.com.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China. caohua0791@163.com.'}]",Journal of cardiothoracic surgery,['10.1186/s13019-020-01282-0']
2682,32933577,Long-term physical activity on prescription intervention for patients with insufficient physical activity level-a randomized controlled trial.,"BACKGROUND


Physical activity (PA) can be used to prevent and treat diseases. In Sweden, licensed healthcare professionals use PA on prescription (PAP) to support patients to increase their PA level. The aim of this randomized controlled trial was to evaluate a 2-year intervention of two different strategies of PAP treatment for patients with insufficient PA level, after a previous 6-month period of ordinary PAP treatment in a primary health care setting.
METHODS


We included 190 patients, 27-77 years, physically inactive with metabolic risk factors where the patients were not responding to a previous 6-month PAP treatment with increased PA. The patients were randomized to either enhanced support from a physiotherapist (PT group) or continued ordinary PAP treatment at the health care centre (HCC group). The PAP treatment included an individualized dialogue; an individually dosed PA recommendation, including a written prescription; and a structured follow-up. In addition to PAP, the PT group received aerobic fitness tests and more frequent scheduled follow-ups. The patient PA level, metabolic health, and health-related quality of life (HRQOL) were measured at baseline and at 1- and 2-year follow-ups.
RESULTS


At the 2-year follow-up, 62.9% of the PT group and 50.8% of the HCC group had increased their PA level and 31.4% vs. 38.5% achieved ≥ 150 min of moderate-intensity PA/week (difference between groups n.s.). Over 2 years, both groups displayed increased high-density lipoproteins (HDL) (p = 0.004 vs. baseline), increased mental health status (MCS) (p = 0.036), and reduced body mass index (BMI) (p = 0.001), with no difference between groups.
CONCLUSION


During long-term PAP interventions, the PA level, metabolic health, and HRQOL increased in patients at metabolic risk without significant differences between groups. The results indicate to be independent of any changes in pharmacological treatment. We demonstrated that the PAP treatment was feasible in ordinary primary care. Both the patients and the healthcare system benefitted from the improvement in metabolic risk factors. Future studies should elucidate effective long-term PAP-treatment strategies.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03012516 . Registered on 30 December 2016-retrospectively registered.",2020,"Over 2 years, both groups displayed increased high-density lipoproteins (HDL) (p = 0.004 vs. baseline), increased mental health status (MCS) (p = 0.036), and reduced body mass index (BMI) (p = 0.001), with no difference between groups.
","['patients with insufficient physical activity level', '190 patients, 27-77\u2009years, physically inactive with metabolic risk factors where the patients were not responding to a previous 6-month PAP treatment with increased PA', 'patients with insufficient PA level, after a previous 6-month period of ordinary PAP treatment in a primary health care setting']","['HCC', 'PAP', 'PAP treatment', 'enhanced support from a physiotherapist (PT group) or continued ordinary PAP treatment at the health care centre (HCC group']","['reduced body mass index (BMI', 'PA level', 'patient PA level, metabolic health, and health-related quality of life (HRQOL', 'PA level, metabolic health, and HRQOL', 'metabolic risk factors', 'mental health status (MCS', 'high-density lipoproteins (HDL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",190.0,0.056787,"Over 2 years, both groups displayed increased high-density lipoproteins (HDL) (p = 0.004 vs. baseline), increased mental health status (MCS) (p = 0.036), and reduced body mass index (BMI) (p = 0.001), with no difference between groups.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lundqvist', 'Affiliation': 'Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. stefan.lundqvist@vgregion.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Börjesson', 'Affiliation': 'Center for Health and Performance (CHP), University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Cider', 'Affiliation': 'Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hagberg', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Camilla Bylin', 'Initials': 'CB', 'LastName': 'Ottehall', 'Affiliation': 'Centrum för fysisk aktivitet Göteborg, Gothenburg, Region Västra Götaland, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Sjöström', 'Affiliation': 'Centrum för fysisk aktivitet Göteborg, Gothenburg, Region Västra Götaland, Sweden.'}, {'ForeName': 'Maria E H', 'Initials': 'MEH', 'LastName': 'Larsson', 'Affiliation': 'Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Trials,['10.1186/s13063-020-04727-y']
2683,32933625,[Clinical effect of recombinant human interferon α1b adjuvant therapy in infectious mononucleosis: a prospective randomized controlled trial].,"OBJECTIVE


To study the clinical effect of recombinant human interferon α1b assisting acyclovir on immune function, inflammatory factors, and myocardial zymogram in children with infectious mononucleosis (IM).
METHODS


A total of 182 children with IM who were admitted to the hospital from January to December, 2018, were divided into an observation group with 91 children and a control group with 91 children using a random number table. The children in the control group were treated with intravenous drip of acyclovir, and those in the observation group were treated with inhalation of recombinant human interferon α1b in addition to the treatment in the control group. The two groups were compared in terms of clinical symptoms, immune function, inflammatory response, myocardial zymogram, and adverse reactions.
RESULTS


Compared with the control group, the observation group had significantly shorter time to body temperature recovery and disappearance of isthmopyra, cervical lymph node enlargement, hepatomegaly, and splenomegaly (P<0.05). After treatment, both groups had significant increases in CD4 + , CD4 + /CD8 + , and CD19 + , and the observation group had significantly higher levels of these markers than the control group (P<0.05). After treatment, both groups had significant reductions in the levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB, and the treatment group had significantly lower levels of these markers than the control group (P<0.05). There was no significant difference in the incidence rate of adverse reactions between the two groups after treatment (P>0.05).
CONCLUSIONS


For children with IM, recombinant human interferon α1b assisting acyclovir can effectively improve immune function, inhibit inflammatory reaction, reduce myocardial injury, and thus alleviate clinical symptoms.",2020,"After treatment, both groups had significant reductions in the levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB, and the treatment group had significantly lower levels of these markers than the control group (P<0.05).","['children with infectious mononucleosis (IM', '182 children with IM who were admitted to the hospital from January to December, 2018, were divided into an observation group with 91 children and a control group with 91 children using a random number table', 'infectious mononucleosis']","['intravenous drip of acyclovir', 'recombinant human interferon α1b', 'recombinant human interferon α1b assisting acyclovir', 'recombinant human interferon α1b adjuvant therapy']","['CD4 + , CD4 + /CD8 + , and CD19 ', 'levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB', 'shorter time to body temperature recovery and disappearance of isthmopyra, cervical lymph node enlargement, hepatomegaly, and splenomegaly', 'incidence rate of adverse reactions', 'immune function, inflammatory factors, and myocardial zymogram', 'clinical symptoms, immune function, inflammatory response, myocardial zymogram, and adverse reactions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0235592', 'cui_str': 'Cervical lymphadenopathy'}, {'cui': 'C0019209', 'cui_str': 'Large liver'}, {'cui': 'C0038002', 'cui_str': 'Splenomegaly'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",182.0,0.0339157,"After treatment, both groups had significant reductions in the levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB, and the treatment group had significantly lower levels of these markers than the control group (P<0.05).","[{'ForeName': 'Sha-Sha', 'Initials': 'SS', 'LastName': 'Dai', 'Affiliation': ""Department of Infectious Diseases, Children's Hospital Affiliated to Nanjing Medical University, Nanjing 210000, China. kx06m1@163.com.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2684,32933746,Postoperative delirium is associated with decreased recovery of ambulation one-month after surgery.,"BACKGROUND


We hypothesized that postoperative delirium is associated with diminished recovery toward baseline preoperative ambulation levels one-month postoperatively.
METHODS


Patients included were ≥60 years old undergoing inpatient operations. Ambulation was measured as steps/day using an accelerometer worn for ≥3-days preoperatively and ≥28-days postoperatively. Primary outcome was the percent recovery of preoperative steps.
RESULTS


109 patients were included; 17 (16%) developed postoperative delirium. Recovery of ambulation toward preoperative baseline at postoperative day-28 was decreased in delirium group (34% vs. 69%; p < 0.01). Immediate postoperative ambulation was similar in the delirium vs. no-delirium groups (p = 0.79). Delirium occurred on average on postoperative 3 ± 4 days. Subsequently, ambulation was decreased in the delirium group compared to non-delirium group at postoperative week-1 (p = 0.01), week-2 (p = 0.02), week-3 (p < 0.01) and week-4 (p < 0.01).
CONCLUSION


Patients undergoing inpatient operations who develop delirium recover only one-third of their baseline steps one-month postoperatively. Postoperative delirium results in a decreased recovery towards baseline ambulation for at least 4-weeks following major operations in comparison to non-delirious patients. The decrease in ambulation in the delirium versus no-delirium groups occurred after the occurrence of postoperative delirium.",2020,Immediate postoperative ambulation was similar in the delirium vs. no-delirium groups (p = 0.79).,['Patients included were ≥60 years old undergoing inpatient operations'],[],"['Delirium', 'ambulation', 'Immediate postoperative ambulation', 'postoperative delirium', 'percent recovery of preoperative steps', 'Ambulation', 'Recovery of ambulation toward preoperative baseline at postoperative day-28']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",109.0,0.17125,Immediate postoperative ambulation was similar in the delirium vs. no-delirium groups (p = 0.79).,"[{'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO, USA; Department of Surgery, University of Colorado, Aurora, CO, USA. Electronic address: thomas.robinson@cuanschutz.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kovar', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Carmichael', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Doug M', 'Initials': 'DM', 'LastName': 'Overbey', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Goode', 'Affiliation': 'Department of Surgery, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Teresa S', 'Initials': 'TS', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO, USA; Department of Surgery, University of Colorado, Aurora, CO, USA.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.08.031']
2685,32933775,Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial.,"OBJECTIVE


To evaluate the five-year clinical performance of Scotchbond Universal Adhesive (SU; 3M Oral Care, St. Paul, MN, USA) in non-carious cervical lesions (NCCLs) using two evaluation criteria.
METHODS


Thirty-nine patients participated in this study. Two hundred restorations were assigned to four groups: SU-ERm: etch-and-rinse + moist dentin; SU-ERd: etch-and-rinse + dry dentin; SU-Set: selective enamel etching; and SU-SE: self-etch. A nanofilled composite resin was placed incrementally. The restorations were evaluated at baseline and after 5 years using both the World Dental Federation (FDI) and the United States Public Health Service (USPHS) criteria. The survival rates (retention/fractures) were calculated with the Kaplan-Meier and the log-rank test. For the secondary outcomes, Friedman repeated measures analysis of variance by rank was applied (α = 0.05).
RESULTS


After 5 years the recall rate was 86%. The retention/fracture rates were 93% for Erm and ERd, 88.4% for SEet and 81.4% for SE. A significant difference was observed for SE vs. ERd and SE vs. ERm (p = 0.01). Also, marginal discoloration and adaptation showed significant differences with ERm and ERd resulting in fewer marginal discrepancies than SE (p < 0.05).
SIGNIFICANCE


After 5 years, the clinical behavior of the universal adhesive in the etch-and-rinse strategy was better when compared to the self-etch strategy. The use of selective enamel etching is highly recommended for the self-etch strategy. The FDI and USPHS evaluation criteria showed similar results after 5 years.",2020,"After 5 years, the clinical behavior of the universal adhesive in the etch-and-rinse strategy was better when compared to the self-etch strategy.","['Two hundred restorations', 'Thirty-nine patients participated in this study', 'non-carious cervical lesions (NCCLs']","['SU-ERm: etch-and-rinse + moist dentin; SU-ERd: etch-and-rinse + dry dentin; SU-Set: selective enamel etching', 'Scotchbond Universal Adhesive (SU; 3M Oral Care, St. Paul, MN, USA']","['survival rates (retention/fractures', 'recall rate', 'clinical behavior of the universal adhesive', 'retention/fracture rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}]","[{'cui': 'C0074197', 'cui_str': 'Scotchbond'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0206656', 'cui_str': 'Embryonal rhabdomyosarcoma'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}]",200.0,0.120504,"After 5 years, the clinical behavior of the universal adhesive in the etch-and-rinse strategy was better when compared to the self-etch strategy.","[{'ForeName': 'Thalita', 'Initials': 'T', 'LastName': 'de Paris Matos', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Perdigão', 'Affiliation': 'University of Minnesota, School of Dentistry, Department of Restorative Sciences, Minneapolis, MN, USA. Electronic address: perdi001@umn.edu.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'de Paula', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of West Paraná, Cascavel, PR, Brazil; Methodist University, Santos, SP, Brazil.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Coppla', 'Affiliation': 'School of Dentistry, Centro de Ensino Superior dos Campos Gerais, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Hass', 'Affiliation': 'Postgraduate Program in Dentistry, University Northern Parana, Londrina, PR, Brazil.'}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Scheffer', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of West Paraná, Cascavel, PR, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.08.007']
2686,32933794,Effects of preoperative individualized audiovisual education on anxiety and comfort in patients undergoing laparoscopic cholecystectomy: randomised controlled study.,"OBJECTIVE


The study aimed to determine the effects of preoperative individualized audiovisual education for laparoscopic cholecystectomy patients on postoperative anxiety and comfort (pain, nausea, and vomiting).
METHOD


This study was a randomized clinical trial on 124 patients undergoing laparoscopic cholecystectomy. Patients were randomized into an intervention group (individualized audiovisual education) or a control group (standard education). The primary outcome was change in anxiety and comfort levels between the intervention and control groups at baseline and follow-up. Secondary outcomes were change between groups in Patient Learning Needs Scale scores and vital signs.
RESULTS


Although the preoperative visual analog scale (VAS)-pain and VAS-nausea scores of the patients in both groups were similar, the postoperative VAS-pain and VAS-nausea levels of the intervention group were significantly lower than that of the control group (p < 0.05). The anxiety levels of the intervention group were also lower both before (42.79 ± 4.29) and after (39.08 ± 3.49) surgery than that of the control group (50.98 ± 5.45 and 44.41 ± 4.77, respectively).
CONCLUSION


This study showed that preoperative individualized audiovisual education was effective in reducing anxiety and improving patient comfort.
PRACTICE IMPLICATIONS


Preoperative individualized audiovisual education is crucial for clinical care and can be integrated into other patients because of its positive effects on postoperative recovery outcomes.",2020,"The anxiety levels of the intervention group were also lower both before (42.79 ± 4.29) and after (39.08 ± 3.49) surgery than that of the control group (50.98 ± 5.45 and 44.41 ± 4.77, respectively).
","['patients undergoing laparoscopic cholecystectomy', 'laparoscopic cholecystectomy patients', '124 patients undergoing']","['intervention group (individualized audiovisual education) or a control group (standard education', 'laparoscopic cholecystectomy', 'preoperative individualized audiovisual education']","['postoperative VAS-pain and VAS-nausea levels', 'anxiety levels', 'Patient Learning Needs Scale scores and vital signs', 'postoperative anxiety and comfort (pain, nausea, and vomiting', 'anxiety and improving patient comfort', 'anxiety and comfort', 'preoperative visual analog scale (VAS)-pain and VAS-nausea scores', 'change in anxiety and comfort levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3839628', 'cui_str': 'Level of nausea'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}]",124.0,0.0606823,"The anxiety levels of the intervention group were also lower both before (42.79 ± 4.29) and after (39.08 ± 3.49) surgery than that of the control group (50.98 ± 5.45 and 44.41 ± 4.77, respectively).
","[{'ForeName': 'Hülya Kizil', 'Initials': 'HK', 'LastName': 'Toğaç', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Health Science Department of Surgical Nursing, Manisa, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': 'Manisa Celal Bayar University, Faculty of Health Science Department of Surgical Nursing, Manisa, Turkey. Electronic address: emelyilmazcbu@gmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.026']
2687,32933919,Machine learning predicts stem cell transplant response in severe scleroderma.,"OBJECTIVE


The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial demonstrated clinical benefit of haematopoietic stem cell transplant (HSCT) compared with cyclophosphamide (CYC). We mapped PBC (peripheral blood cell) samples from the SCOT clinical trial to scleroderma intrinsic subsets and tested the hypothesis that they predict long-term response to HSCT.
METHODS


We analysed gene expression from PBCs of SCOT participants to identify differential treatment response. PBC gene expression data were generated from 63 SCOT participants at baseline and follow-up timepoints. Participants who completed treatment protocol were stratified by intrinsic gene expression subsets at baseline, evaluated for event-free survival (EFS) and analysed for differentially expressed genes (DEGs).
RESULTS


Participants from the fibroproliferative subset on HSCT experienced significant improvement in EFS compared with fibroproliferative participants on CYC (p=0.0091). In contrast, EFS did not significantly differ between CYC and HSCT arms for the participants from the normal-like subset (p=0.77) or the inflammatory subset (p=0.1). At each timepoint, we observed considerably more DEGs in HSCT arm compared with CYC arm with HSCT arm showing significant changes in immune response pathways.
CONCLUSIONS


Participants from the fibroproliferative subset showed the most significant long-term benefit from HSCT compared with CYC. This study suggests that intrinsic subset stratification of patients may be used to identify patients with SSc who receive significant benefit from HSCT.",2020,"At each timepoint, we observed considerably more DEGs in HSCT arm compared with CYC arm with HSCT arm showing significant changes in immune response pathways.
",['severe scleroderma'],"['haematopoietic stem cell transplant (HSCT', 'Cyclophosphamide or Transplantation (SCOT', 'HSCT', 'Machine learning', 'cyclophosphamide (CYC']","['PBC gene expression data', 'immune response pathways', 'EFS']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}]","[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",63.0,0.143652,"At each timepoint, we observed considerably more DEGs in HSCT arm compared with CYC arm with HSCT arm showing significant changes in immune response pathways.
","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Franks', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Martyanov', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Tammara A', 'Initials': 'TA', 'LastName': 'Wood', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Pinckney', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'NIAID/NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'Rheumatology and Clinical Immunogenetics, The University of Texas Health Science Center Houston Medical School, Houston, Texas, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McSweeney', 'Affiliation': 'Rocky Mountain Blood and Marrow Transplant Program, Colorado Blood Cancer Institute, Denver, Colorado, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': 'Rocky Mountain Blood and Marrow Transplant Program, Colorado Blood Cancer Institute, Denver, Colorado, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Whitfield', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA michael.l.whitfield@dartmouth.edu.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217033']
2688,32933927,Effect of a pulmonary rehabilitation programme of 8 weeks compared to 12 weeks duration on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): protocol for a randomised controlled trial.,"INTRODUCTION


Pulmonary rehabilitation (PR) is a key component in the management of chronic obstructive pulmonary disease (COPD). There is no strong evidence on the optimal duration of PR programmes. The aim of this study is to determine whether an 8-week PR programme is equivalent to a 12-week PR programme in people with COPD.
METHODS AND ANALYSIS


This study will be a prospective, multisite, randomised controlled, equivalence trial with assessors blinded to group allocation and intention-to-treat analysis. 72 participants with COPD will be recruited and randomised to either a supervised, twice weekly for 8 weeks or a 12-week PR programme of exercise training and education.
PRIMARY OUTCOME


endurance shuttle walk test.
SECONDARY OUTCOMES


will include St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions at 6 months and 12 months. Repeated measures analysis of variance will be used to analyse differences between the groups for all outcomes.
ETHICS AND DISSEMINATION


Ethics approval was gained from all participating sites. Results of the trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ACTRN12616001586404.",2020,"SECONDARY OUTCOMES


will include St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions at 6 months and 12 months.","['chronic obstructive pulmonary disease (COPD', '72 participants with COPD', 'people with chronic obstructive pulmonary disease (PuRe Duration', 'people with COPD']","['pulmonary rehabilitation programme', 'Pulmonary rehabilitation (PR', 'PR programme of exercise training and education']","[""St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions"", 'endurance shuttle walk test']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1960627', 'cui_str': 'Endurance shuttle walk test'}]",72.0,0.164128,"SECONDARY OUTCOMES


will include St George's Respiratory Questionnaire, 6-min walk distance, COPD assessment test, Hospital Anxiety and Depression Scale, physical activity monitoring and hospital admissions at 6 months and 12 months.","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Physiotherapy, Balmain Hospital, Balmain, New South Wales, Australia joshua.bishop@health.nsw.gov.au.'}, {'ForeName': 'Lissa', 'Initials': 'L', 'LastName': 'Spencer', 'Affiliation': 'Physiotherapy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Alison', 'Affiliation': 'Physiotherapy, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000687']
2689,32933950,"Comparison of weight-based insulin titration (WIT) and glucose-based insulin titration using basal-bolus algorithm in hospitalized patients with type 2 diabetes: a multicenter, randomized, clinical study.","INTRODUCTION


Subcutaneous administration of insulin is the preferred method for achieving glucose control in non-critically ill patients with diabetes. Glucose-based titration protocols were widely applied in clinical practice. However, most of these algorithms are experience-based and there is considerable variability and complexity. This study aimed to compare the effectiveness and safety of a weight-based insulin titration algorithm versus glucose-based algorithm in hospitalized patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


This randomized clinical trial was carried out at four centers in the South, Central and North China. Inpatients with T2DM were randomly assigned (1:1) to receive weight-based and glucose-based insulin titration algorithms. The primary outcome was the length of time for reaching blood glucose (BG) targets (fasting BG (FBG) and 2-hour postprandial BG (2hBG) after three meals). The secondary outcome included insulin dose for achieving glycemic control and the incidence of hypoglycemia during hospitalization.
RESULTS


Between January 2016 and June 2019, 780 patients were screened, and 575 completed the trial (283 in the weight-based group and 292 in the glucose-based group). The lengths of time for reaching BG targets at four time points were comparable between two groups. FBG reached targets within 3 days and 2hBG after three meals within 4 days. There is no significant difference in insulin doses between two groups at the end of the study. The total daily dosage was about 1 unit/kg/day, and the ratio of basal-to-bolus was about 2:3 in both groups. The incidence of hypoglycemia was similar in both groups, and severe hypoglycemia was not detected in either of the groups.
CONCLUSIONS


Weight-based insulin titration algorithm is equally effective and safe in hospitalized patients with T2DM compared with glucose-based algorithm.
TRIAL REGISTRATION NUMBER


NCT03220919.",2020,"The incidence of hypoglycemia was similar in both groups, and severe hypoglycemia was not detected in either of the groups.
","['non-critically ill patients with diabetes', 'Inpatients with T2DM', 'hospitalized patients with type 2 diabetes mellitus (T2DM', 'hospitalized patients with type 2 diabetes', 'hospitalized patients with T2DM', 'four centers in the South, Central and North China', 'Between January 2016 and June 2019, 780 patients were screened, and 575 completed the trial (283 in the weight-based group and 292 in the glucose-based group']","['Weight-based insulin titration algorithm', 'weight-based insulin titration algorithm versus glucose-based algorithm', 'weight-based insulin titration (WIT) and glucose-based insulin titration using basal-bolus algorithm', 'weight-based and glucose-based insulin titration algorithms']","['lengths of time for reaching BG targets', 'effectiveness and safety', 'severe hypoglycemia', 'length of time for reaching blood glucose (BG) targets (fasting BG (FBG) and 2-hour postprandial BG (2hBG', 'total daily dosage', 'incidence of hypoglycemia', 'insulin dose for achieving glycemic control and the incidence of hypoglycemia during hospitalization']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205112', 'cui_str': 'Basal'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",780.0,0.056287,"The incidence of hypoglycemia was similar in both groups, and severe hypoglycemia was not detected in either of the groups.
","[{'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guangda', 'Initials': 'G', 'LastName': 'Xiang', 'Affiliation': ""Department of Endocrinology, Wuhan General Hospital of Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Du', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yunjuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Singla Sethiel', 'Initials': 'SS', 'LastName': 'Mosha', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wangen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China liwg660@126.com.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001261']
2690,32933953,Protocol for the impact of CBT for insomnia on pain symptoms and central sensitisation in fibromyalgia: a randomised controlled trial.,"INTRODUCTION


Approximately 50% of individuals with fibromyalgia (a chronic widespread pain condition) have comorbid insomnia. Treatment for these comorbid cases typically target pain, but growing research supports direct interventions for insomnia (eg, cognitive behavioural treatment for insomnia (CBT-I)) in these patients. Previous research suggests sustained hyperarousal mediated by a neural central sensitisation mechanism may underlie insomnia and chronic pain symptoms in fibromyalgia. We hypothesise CBT-I will improve insomnia symptoms, improve clinical pain and reduce central sensitisation. The trial will be the first to evaluate the short-term and long-term neural mechanisms underlying insomnia and pain improvements in fibromyalgia. Knowledge obtained from this trial might allow us to develop new or modify current treatments to better target pain mechanisms, perhaps reversing chronic pain or preventing it.
METHODS AND ANALYSIS


Female participants (n=130) 18 years of age and older with comorbid fibromyalgia (with pain severity of at least 50/100) and insomnia will be recruited from the University of Missouri in Columbia, Missouri, and surrounding areas. Participants will be randomised to 8 weeks (plus 4 bimonthly booster sessions) of CBT-I or a sleep hygiene control group (SH). Participants will be assessed at baseline, post-treatment, 6 and 12 months follow-ups. The following assessments will be completed: 2 weeks of daily diaries measuring sleep and pain, daily actigraphy, insomnia severity index, pain-related disability, single night of polysomnography recording, arousal (heart rate variability, cognitive affective arousal), structural and functional MRI to examine pain-related neural activity and plasticity and mood (depression, anxiety).
ETHICS AND DISSEMINATION


Ethics approval was obtained in July 2018 from the University of Missouri. All data are expected to be collected by 2022. Full trial results are planned to be published by 2024. Secondary analyses of baseline data will be subsequently published.
TRIAL REGISTRATION NUMBER


NCT03744156.",2020,Participants will be randomised to 8 weeks (plus 4 bimonthly booster sessions) of CBT-I or a sleep hygiene control group (SH).,"['individuals with fibromyalgia (a chronic widespread pain condition', 'Ethics approval was obtained in July 2018 from the University of Missouri', 'fibromyalgia', 'Female participants (n=130) 18 years of age and older with comorbid fibromyalgia (with pain severity of at least 50/100) and insomnia will be recruited from the University of Missouri in Columbia, Missouri, and surrounding areas']","['CBT', 'CBT-I or a sleep hygiene control group (SH']","['pain symptoms and central sensitisation', 'sleep and pain, daily actigraphy, insomnia severity index, pain-related disability, single night of polysomnography recording, arousal (heart rate variability, cognitive affective arousal), structural and functional MRI to examine pain-related neural activity and plasticity and mood (depression, anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C3178789', 'cui_str': 'Amplified musculoskeletal pain syndrome'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.399601,Participants will be randomised to 8 weeks (plus 4 bimonthly booster sessions) of CBT-I or a sleep hygiene control group (SH).,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri System, Columbia, Missouri, USA mccraec@health.missouri.edu.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Departments of Psychiatry and Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Craggs', 'Affiliation': 'Departments of Physical Therapy and Psychological Sciences, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Deroche', 'Affiliation': 'Department of Health Management and Informatics, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Sahota', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Chokkalingam', 'Initials': 'C', 'LastName': 'Siva', 'Affiliation': 'Division of Immunology and Rheumatology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Rheumatology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, Florida, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033760']
2691,32933954,Acceptability and feasibility of two interventions in the MooDFOOD Trial: a food-related depression prevention randomised controlled trial in overweight adults with subsyndromal symptoms of depression.,"OBJECTIVES


We report on the acceptability, feasibility, dose-response relationship and adherence of two nutritional strategies to improve mood (multinutrient supplements; food-related behavioural activation (F-BA)) studied in a randomised controlled depression prevention trial (the Multi-country cOllaborative project on the rOle of Diet, Food-related behaviour, and Obesity in the prevention of Depression (MooDFOOD) Trial). We also assessed baseline determinants of adherence and assessed whether better adherence resulted in lower depressive symptoms.
DESIGN


Randomised controlled trial with a 2×2 factorial design conducted between 2015 and 2017.
SETTING


Germany, the Netherlands, UK and Spain.
PARTICIPANTS


Community sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder. Main eligibility criteria included age (18-75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5. A total of 76% of the sample was retained at the 12-month follow-up.
INTERVENTIONS


Daily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention over a 1-year period.
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary outcome: self-reported acceptability of the interventions.
SECONDARY OUTCOMES


adherence and self-reported depressive symptoms.
RESULTS


Most participants reported that the F-BA was acceptable (83.61%), feasible to do (65.91%) and would recommend it to a friend (84.57%). Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%). There were statistically significant reductions in depressive symptoms for those who both adhered to the F-BA intervention and had a history of depression (B=-0.08, SE=0.03, p = 0.012) versus those who had no history of depression. Supplement intake had no effect on depressive symptoms irrespective of adherence.
CONCLUSIONS


F-BA may have scope for development as a depression prevention intervention and public health strategy but further refinement and testing are needed.
TRIAL REGISTRATION NUMBER


NCT02529423.",2020,Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%).,"['2×2 factorial design conducted between 2015 and 2017', 'overweight adults with subsyndromal symptoms of depression', 'Community sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder', 'Germany, the Netherlands, UK and Spain', 'MooDFOOD Trial', 'Main eligibility criteria included age (18-75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5']","['Daily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention']","['adherence and self-reported depressive symptoms', 'self-reported acceptability of the interventions', 'Acceptability and feasibility', 'F-BA', 'depressive symptoms irrespective of adherence', 'depressive symptoms', 'history of depression']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0455503', 'cui_str': 'H/O: depression'}]",1025.0,0.417814,Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%).,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK m.owens-solari@exeter.ac.uk.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health research institute, GGZ in Geest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg Annemarie', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science and Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Medical Faculty, Leipzig, Germany.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Penninx', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health research institute, GGZ in Geest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Psychiatry, Amsterdam Public Health research institute, GGZ in Geest Specialized Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Cabout', 'Affiliation': 'Department of Health Sciences, Faculty of Science and Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe-University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Palma de Mallorca, Spain.""}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science and Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034025']
2692,32933955,"Seasonal malaria vaccination: protocol of a phase 3 trial of seasonal vaccination with the RTS,S/AS01 E  vaccine, seasonal malaria chemoprevention and the combination of vaccination and chemoprevention.","INTRODUCTION


Seasonal malaria chemoprevention (SMC), with sulphadoxine-pyrimethamine plus amodiaquine (SP+AQ) is effective but does not provide complete protection against clinical malaria. The RTS,S/AS01 E  malaria vaccine provides a high level of protection shortly after vaccination, but this wanes rapidly. Such a vaccine could be an alternative or additive to SMC. This trial aims to determine whether seasonal vaccination with RTS,S/AS01 E  vaccine could be an alternative to SMC and whether a combination of the two interventions would provide added benefits.
METHODS AND ANALYSIS


This is an individually randomised, double-blind, placebo-controlled trial. 5920 children aged 5-17 months were enrolled in April 2017 in Mali and Burkina Faso. Children in group 1 received three priming doses of RTS,S/AS01 E  vaccine before the start of the 2017 malaria transmission season and a booster dose at the beginning of two subsequent transmission seasons. In addition, they received SMC SP+AQ placebo on four occasions each year. Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year. Children in group 3 received RTS,S/AS01 E  vaccine and four courses of SMC SP+AQ. Incidence of clinical malaria is determined by case detection at health facilities. Weekly active surveillance for malaria is undertaken in a randomly selected subset of children. The prevalence of malaria is measured in surveys at the end of each transmission season. The primary endpoint is the incidence of clinical malaria confirmed by a positive blood film with a minimum parasite density of 5000 /µL. Primary analysis will be by modified intention to treat defined as children who have received the first dose of the malaria or control vaccine.
ETHICS AND DISSEMINATION


The protocol was approved by the national ethics committees of Mali and Burkina Faso and the London School of Hygiene and Tropical Medicine. The results will be presented to all stakeholders and published in open access journals.
TRIAL REGISTRATION NUMBER


NCT03143218; Pre-results.",2020,Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year.,['5920 children aged 5-17 months were enrolled in April 2017 in Mali and Burkina Faso'],"['rabies vaccine', 'SMC SP+AQ placebo', 'placebo', 'SMC SP+AQ', 'sulphadoxine-pyrimethamine plus amodiaquine (SP+AQ', 'RTS,S/AS01 E  vaccine']","['incidence of clinical malaria confirmed by a positive blood film with a minimum parasite density of 5000 /µL', 'prevalence of malaria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]","[{'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",5920.0,0.427938,Children in group 2 received three doses of rabies vaccine in year 1 and hepatitis A vaccine in years 2 and 3 together with four cycles of SMC SP+AQ each year.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK Daniel.Chandramohan@lshtm.ac.uk.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cairns', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Djibrilla', 'Initials': 'D', 'LastName': 'Issiaka', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Koualy', 'Initials': 'K', 'LastName': 'Sanogo', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Almahamoudou', 'Initials': 'A', 'LastName': 'Mahamar', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Sompougdou', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Center, Bamako, Mali.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Milligan', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Opokua', 'Initials': 'O', 'LastName': 'Ofori-Anyinam', 'Affiliation': 'GlaxoSmithKline Biologicals SA, Wavre, Belgium.'}, {'ForeName': 'Jean-Bosco', 'Initials': 'JB', 'LastName': 'Ouedraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035433']
2693,32933995,Concomitant Proton Pump Inhibitor Use and Survival in Urothelial Carcinoma Treated with Atezolizumab.,"PURPOSE


Emerging evidence indicates that gut microbiota dysbiosis can reduce the effectiveness of immune checkpoint inhibitors (ICI). Proton pump inhibitors (PPI) are known to induce gut microbiota changes. However, little is known on the effects of PPIs on outcomes with ICI therapy, and it has not been explored in urothelial cancer treatment.
EXPERIMENTAL DESIGN


Individual-participant data from the advanced urothelial cancer trials, IMvigor210 (single-arm atezolizumab trial,  n  = 429) and IMvigor211 (phase III randomized trial of atezolizumab vs. chemotherapy,  n  = 931) were pooled in a Cox proportional hazard analysis assessing the association between PPI use and overall survival (OS) and progression-free survival (PFS). PPI use was defined as any PPI administration between 30 days prior and 30 days after treatment initiation.
RESULTS


Of the 1,360 participants, 471 (35%) received a PPI within the 60-day window. PPI use was associated with significantly worse OS [HR (95% confidence interval (CI)) = 1.52 (1.27-1.83),  P  < 0.001] and PFS [1.38 (1.18-1.62),  P  < 0.001] with atezolizumab, but not chemotherapy ( P  > 0.05). In the randomized cohort of IMvigor211, the OS treatment effect [HR (95% CI)] of atezolizumab versus chemotherapy was 1.04 (0.81-1.34) for PPI users, compared with 0.69 (0.56-0.84) for PPI nonusers ( P   interaction  = 0.013). Similar associations were noted in the PD-L1 IC2/3 population.
CONCLUSIONS


This study indicates PPI use is a negative prognostic marker in advanced urothelial carcinoma treated with ICI therapy, but not chemotherapy. Furthermore, the analysis suggests PPIs influence the magnitude of ICI efficacy, and this warrants further investigation.",2020,"< 0.001] and PFS [1.38 (1.18-1.62),  P  < 0.001] with atezolizumab, but not chemotherapy ( P  > 0.05).","['Individual-participant data from the advanced urothelial cancer trials, IMvigor210 (single-arm atezolizumab trial,  n  = 429) and', 'Of the 1,360 participants, 471 (35%) received a PPI within the 60-day window', 'advanced urothelial carcinoma treated with']","['Proton pump inhibitors (PPI', 'ICI therapy', 'Atezolizumab', 'atezolizumab vs. chemotherapy', 'IMvigor211', 'atezolizumab']","['ICI efficacy', 'PPI use and overall survival (OS) and progression-free survival (PFS', 'PFS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1360.0,0.143162,"< 0.001] and PFS [1.38 (1.18-1.62),  P  < 0.001] with atezolizumab, but not chemotherapy ( P  > 0.05).","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia. ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1876']
2694,32934029,"Correction: Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial.",,2020,,['Previously Treated Advanced Melanoma'],['Toripalimab'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]",[],[],,0.0571879,,"[{'ForeName': 'Bixia', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Chi', 'Affiliation': ''}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Lihou', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Shuikui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Xiaoshi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3168']
2695,32934137,"Pegloticase in combination with methotrexate in patients with uncontrolled gout: A multicenter, open-label study (MIRROR).","OBJECTIVE


To examine the efficacy and safety of pegloticase in combination with methotrexate in patients with uncontrolled gout in an exploratory, open-label clinical trial (NCT03635957) prior to a randomized, controlled trial.
METHODS


A multicenter, open-label, efficacy and safety study of pegloticase with methotrexate cotreatment was conducted in patients with uncontrolled gout. Patients were administered oral methotrexate (15 mg/week) and folic acid (1 mg/day) 4 weeks prior to and throughout pegloticase treatment. The primary study outcome was the proportion of responders, defined as sUA <6 mg/dL for ≥80% of the time during month 6 (weeks 20, 22, and 24). All analyses were performed on a modified intent-to-treat population, defined as patients who received ≥1 pegloticase infusion.
RESULTS


Seventeen patients were screened and 14 patients (all men, average age: 49.3 ± 8.7 years) were enrolled. On Day 1, mean sUA was 9.2 ± 2.5 mg/dL and 12 of the 14 patients had visible tophi. At the 6 month timepoint, 11/14 (78.6%, 95%CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (pre-infusion sUA values greater than 6 mg/dL at 2 consecutive scheduled visits). All patients tolerated methotrexate. No new safety concerns were identified.
CONCLUSION


In this study, an increased proportion of patients maintained therapeutic response at 6 months when treated concomitantly with methotrexate and pegloticase when compared to the previously reported 42% using pegloticase alone. These results support the need for a randomized study of methotrexate or placebo with pegloticase to validate these open label findings.",2020,"At the 6 month timepoint, 11/14 (78.6%, 95%CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (pre-infusion sUA values greater than 6 mg/dL at 2 consecutive scheduled visits).","['patients with uncontrolled gout', 'Seventeen patients were screened and 14 patients (all men, average age: 49.3 ± 8.7 years) were enrolled', 'patients with uncontrolled gout in an exploratory, open-label clinical trial (NCT03635957) prior']","['folic acid', 'methotrexate', 'oral methotrexate', 'methotrexate cotreatment', 'methotrexate or placebo', 'Pegloticase in combination with methotrexate']","['efficacy and safety', 'proportion of responders', 'proportion of patients maintained therapeutic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2350656', 'cui_str': 'Pegloticase'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}]",17.0,0.033204,"At the 6 month timepoint, 11/14 (78.6%, 95%CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (pre-infusion sUA values greater than 6 mg/dL at 2 consecutive scheduled visits).","[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Botson', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'John R P', 'Initials': 'JRP', 'LastName': 'Tesser', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Bennett', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Kenney', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Peloso', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Obermeyer', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'LaMoreaux', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Weinblatt', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': ""Orthopedic Physicians Alaska, Anchorage, AK; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, AZ; Arthritis Northwest, PLLC, Spokane, WA; Horizon Therapeutics, Lake Forest, IL; Horizon Therapeutics, Lake Forest, IL; Brigham and Women's Hospital, Boston, MA; Western Washington Arthritis Clinic, Bothell, WA. Conflict of interest: Dr. Botson has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/speaker fees >10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. Dr. Tesser has received research grants/support from Horizon. Dr. Bennett has no financial relationships that pose a potential conflict of interest. Dr. Kenney has received research support from Horizon Therapeutics as a study site and principal investigator. He has also served as a speaker for Horizon Therapeutics. Dr. Peloso, Ms. Obermeyer, and Dr. LaMoreaux are employees of and own stock in Horizon Therapeutics. Dr. Weinblatt has received grants from Amgen, Bristol-Myers Squibb, Crescendo Bioscience, Lilly and Sanofi. He has received consulting fees >10k from Bristol Myers Squibb, Corona, and Lilly and <10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; he has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. Dr. Peterson has received research support from Horizon Therapeutics (study site/investigator). He has also served as an advisor and speaker for Horizon Therapeutics. Corresponding Author: John K. Botson, MD, RPh, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508. jbotson@opaak.com.""}]",The Journal of rheumatology,['10.3899/jrheum.200460']
2696,32934207,Walking after incomplete spinal cord injury with an implanted neuromuscular electrical stimulation system and a hinged knee replacement: a single-subject study.,"STUDY DESIGN


Single-subject repeated measures study.
OBJECTIVES


Neuromuscular electrical stimulation (NMES) can enhance walking for people with partial paralysis from incomplete spinal cord injury (iSCI). This single-subject study documents an individual's experience who both received an experimental implanted NMES system and underwent clinical bilateral hinged total knee arthroplasty (TKA). She walked in the community with knee pain prior to either intervention. Walking performance improved with an implanted NMES system. Knee pain and instability continued to worsen over time and eventually required TKA. This study evaluates the effects of these interventions.
SETTING


Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland OH, USA.
METHODS


The differential and combined effects of NMES and hinged knee replacement were assessed in terms of walking speed, toe clearance, knee angle, and participant perceptions with and without stimulation assistance both before and after TKA.
RESULTS


The combined approach both reduced pain and restored walking ability to levels achieved prior to developing significant knee pain that prevented walking without NMES. There was an interaction effect between NMES and TKA on walking speed. Toe clearance consistently improved with stimulation assistance and TKA prevented significant knee hyperextension. The greatest impact was on endurance. Knee replacement re-enabled long distance walking with the addition of stimulation again more than doubling her maximum walking distance from 214 to 513 m.
CONCLUSIONS


These data support further research of combined implantable interventions that may benefit people with iSCI. Furthermore, joint laxity and pain may not necessarily be contraindications to NMES if addressed with conventional clinical treatments.",2020,The combined approach both reduced pain and restored walking ability to levels achieved prior to developing significant knee pain that prevented walking without NMES.,"['Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland OH, USA', 'people with partial paralysis from incomplete spinal cord injury (iSCI']","['NMES and hinged knee replacement', 'Knee replacement re-enabled long distance walking with the addition of stimulation again more than doubling her maximum walking distance', 'TKA', 'Neuromuscular electrical stimulation (NMES', 'implanted neuromuscular electrical stimulation system and a hinged knee replacement', 'NMES and TKA', 'experimental implanted NMES system and underwent clinical bilateral hinged total knee arthroplasty (TKA']","['walking speed, toe clearance, knee angle, and participant perceptions with and without stimulation assistance', 'Walking performance', 'Toe clearance', 'knee hyperextension', 'Knee pain and instability continued to worsen over time and eventually required TKA', 'walking speed']","[{'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0457406', 'cui_str': 'Hinge'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0336547', 'cui_str': 'Experimental implant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0546964', 'cui_str': 'Genu recurvatum'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",,0.0562222,The combined approach both reduced pain and restored walking ability to levels achieved prior to developing significant knee pain that prevented walking without NMES.,"[{'ForeName': 'Nathaniel S', 'Initials': 'NS', 'LastName': 'Makowski', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA. nmakowski@metrohealth.org.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Lombardo', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Foglyano', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Kobetic', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pinault', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Selkirk', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Triolo', 'Affiliation': 'Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.'}]",Spinal cord series and cases,['10.1038/s41394-020-00336-8']
2697,32934291,Fine scale spatial investigation of multiple insecticide resistance and underlying target-site and metabolic mechanisms in Anopheles gambiae in central Côte d'Ivoire.,"Routine monitoring of occurrence, levels and mechanisms of insecticide resistance informs effective management strategies, and should be used to assess the effect of new tools on resistance. As part of a cluster randomised controlled trial evaluating a novel insecticide-based intervention in central Côte d'Ivoire, we assessed resistance and its underlying mechanisms in Anopheles gambiae populations from a subset of trial villages. Resistance to multiple insecticides in An. gambiae s.s. and An. coluzzii was detected across villages, with dose-response assays demonstrating extremely high resistance intensity to the pyrethroid deltamethrin (> 1,500-fold), and mortality following exposure to pyrethroid-treated bednets was low (< 30% mortality in cone bioassays). The 1014F kdr mutation was almost fixed (≥ 90%) in all villages but the 1575Y kdr-amplifying mutation was relatively rare (< 15%). The carbamate and organophosphate resistance-associated Ace-1 G119S mutation was also detected at moderate frequencies (22-43%). Transcriptome analysis identified overexpression of P450 genes known to confer pyrethroid resistance (Cyp9K1, Cyp6P3, and Cyp6M2), and also a carboxylesterase (COEAE1F) as major candidates. Cyp6P3 expression was high but variable (up to 33-fold) and correlated positively with deltamethrin resistance intensity across villages (r 2  = 0.78, P = 0.02). Tools and strategies to mitigate the extreme and multiple resistance provided by these mechanisms are required in this area to avoid future control failures.",2020,"Cyp6P3 expression was high but variable (up to 33-fold) and correlated positively with deltamethrin resistance intensity across villages (r 2  = 0.78, P = 0.02).","['Anopheles gambiae populations from a subset of trial villages', ""Anopheles gambiae in central Côte d'Ivoire""]",['novel insecticide-based intervention'],"['deltamethrin resistance intensity', 'Cyp6P3 expression', 'carbamate and organophosphate resistance-associated Ace-1 G119S mutation']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0057233', 'cui_str': 'decamethrin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0006948', 'cui_str': 'Carbamates'}, {'cui': 'C0031701', 'cui_str': 'Phosphoric acid ester'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.0429302,"Cyp6P3 expression was high but variable (up to 33-fold) and correlated positively with deltamethrin resistance intensity across villages (r 2  = 0.78, P = 0.02).","[{'ForeName': 'Welbeck A', 'Initials': 'WA', 'LastName': 'Oumbouke', 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK. welbeck.oumbouke@lshtm.ac.uk.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pignatelli', 'Affiliation': 'Department of Vector Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.'}, {'ForeName': 'Antoine M G', 'Initials': 'AMG', 'LastName': 'Barreaux', 'Affiliation': 'School of Biological Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Innocent Z', 'Initials': 'IZ', 'LastName': 'Tia', 'Affiliation': ""Institut Pierre Richet (IPR), Institut National de Santé Publique (INSP), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Alphonsine A', 'Initials': 'AA', 'LastName': 'Koffi', 'Affiliation': ""Institut Pierre Richet (IPR), Institut National de Santé Publique (INSP), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Ludovic P', 'Initials': 'LP', 'LastName': 'Ahoua Alou', 'Affiliation': ""Institut Pierre Richet (IPR), Institut National de Santé Publique (INSP), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Eleanore D', 'Initials': 'ED', 'LastName': 'Sternberg', 'Affiliation': 'Department of Vector Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Thomas', 'Affiliation': 'Department of Entomology, Center for Infectious Disease Dynamics, The Pennsylvania State University, University Park, PA, 16802, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Weetman', 'Affiliation': 'Department of Vector Biology, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': ""N'Guessan"", 'Affiliation': 'Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.'}]",Scientific reports,['10.1038/s41598-020-71933-8']
2698,32934335,Impact of self-assembling peptides in remineralisation of artificial early enamel lesions adjacent to orthodontic brackets.,"Enamel demineralisation can occur as a side effect during orthodontic treatment with fixed appliances. This study aimed to evaluate the efficacy of the self-assembling peptide P 11 -4 for remineralisation combined with fluorides, compared to application of fluoride varnish alone. De- and remineralisation was assessed by Quantitative light-induced fluorescence (QLF). Orthodontic brackets were bonded on 108 human enamel samples and white spot lesions were created. The samples were allocated randomly into three groups: Group I received no treatment, group II had a single application of fluoride varnish (22,600 ppm), and group III was treated with P 11 -4 following a single application of fluoride varnish. Quantitative light-induced fluorescence (QLF) measurements were performed at baseline, after demineralisation and after storage in remineralisation solution for 7 and 30 days. Non-parametric tests (Kruskal-Wallis test and Friedman test) were used for further analysis. After demineralisation, all samples showed a median ΔF -9.38% ± 2.79. After 30 days median ΔF values were as followed: group I = -9.04% ± 2.51, group II = -7.89 ± 2.07, group III = -6.08% ± 2.79). The median ΔF values differed significantly between all groups at all investigation times (p < 0.00001). Application of P 11 -4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.",2020,Application of P 11 -4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.,['remineralisation of artificial early enamel lesions adjacent to orthodontic brackets'],"['fluoride varnish', 'fluoride varnish alone']","['Quantitative light-induced fluorescence (QLF', 'Quantitative light-induced fluorescence (QLF) measurements', 'median ΔF values', 'De- and remineralisation']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C4704843', 'cui_str': 'Quantitative Light-Induced Fluorescence'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0197051,Application of P 11 -4 with fluoride varnish was superior to the use of fluorides alone for remineralisation of enamel adjacent to brackets.,"[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Jablonski-Momeni', 'Affiliation': 'Department of Orthodontics, Dental School, Philipps University of Marburg, Georg-Voigt-Str. 3, 35039, Marburg, Germany. momeni@staff.uni-marburg.de.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nothelfer', 'Affiliation': 'Department of Orthodontics, Dental School, Philipps University of Marburg, Georg-Voigt-Str. 3, 35039, Marburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morawietz', 'Affiliation': 'Fraunhofer Institute for Microstructure of Materials and Systems IMWS, Halle (Saale), Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kiesow', 'Affiliation': 'Fraunhofer Institute for Microstructure of Materials and Systems IMWS, Halle (Saale), Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Korbmacher-Steiner', 'Affiliation': 'Department of Orthodontics, Dental School, Philipps University of Marburg, Georg-Voigt-Str. 3, 35039, Marburg, Germany.'}]",Scientific reports,['10.1038/s41598-020-72185-2']
2699,32934343,Novel urinary protein biomarker panel for early diagnosis of gastric cancer.,"BACKGROUND


With the goal of discovering non-invasive biomarkers for early diagnosis of GC, we conducted a case-control study utilising urine samples from individuals with predominantly early GC vs. healthy control (HC).
METHODS


Among urine samples from 372 patients, age- and sex-matched 282 patients were randomly divided into three groups: 18 patients in a discovery cohort; 176 patients in a training cohort and 88 patients in a validation cohort.
RESULTS


Among urinary proteins identified in the comprehensive quantitative proteomics analysis, urinary levels of TFF1 (uTFF1) and ADAM12 (uADAM12) were significantly independent diagnostic biomarkers for GC, in addition to Helicobacter pylori status. A urinary biomarker panel combining uTFF1, uADAM12 and H. pylori significantly distinguished between HC and GC patients in both training and validation cohorts. On the analysis for sex-specific biomarkers, this combination panel demonstrated a good AUC of 0.858 for male GC, whereas another combination panel of uTFF1, uBARD1 and H. pylori also provided a good AUC of 0.893 for female GC. Notably, each panel could distinguish even stage I GC patients from HC patients (AUC = 0.850 for males; AUC = 0.845 for females).
CONCLUSIONS


Novel urinary protein biomarker panels represent promising non-invasive biomarkers for GC, including early-stage disease.",2020,"A urinary biomarker panel combining uTFF1, uADAM12 and H. pylori significantly distinguished between HC and GC patients in both training and validation cohorts.","['individuals with predominantly early GC vs. healthy control (HC', 'I GC patients from HC patients (AUC\u2009=\u20090.850 for males; AUC\u2009=\u20090.845 for females', 'Among urine samples from 372 patients, age- and', 'early diagnosis of gastric cancer', 'sex-matched 282 patients were randomly divided into three groups: 18 patients in a discovery cohort; 176 patients in a training cohort and 88 patients in a validation cohort']",['Novel urinary protein biomarker panel'],['urinary levels of TFF1 (uTFF1) and ADAM12'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0072523', 'cui_str': 'TFF1 protein, human'}]",282.0,0.0159483,"A urinary biomarker panel combining uTFF1, uADAM12 and H. pylori significantly distinguished between HC and GC patients in both training and validation cohorts.","[{'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. tshimura@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Dayde', 'Affiliation': 'Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okuda', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Ebi', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Tamaki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Okazaki Public Health Center, 1-3 Harusaki, Harisaki-cho, Okazaki, 444-0827, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan.'}, {'ForeName': 'Samir M', 'Initials': 'SM', 'LastName': 'Hanash', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Taguchi', 'Affiliation': 'Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kataoka', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.'}]",British journal of cancer,['10.1038/s41416-020-01063-5']
2700,32934400,Analgesic sparing effect of dexamethasone with levobupivacaine in quadratus lumborum block in patients undergoing unilateral inguinal hernia repair: A prospective randomised controlled trial.,"Background


Quadratus lumborum block (QLB) provides somatic and visceral analgesia to the lower thoracic and abdominal wall. The aim was to investigate the analgesic effect of dexamethasone with levobupivacaine in QLB in patients undergoing unilateral inguinal hernia repair surgery.
Methods


A total of 90 patients of American Society of Anaesthesiologists (ASA) I/II were randomly divided into two groups. Group L received 0.25% levobupivacaine (20 ml) + normal saline (1 ml) and group D received 0.25% levobupivacaine (20 ml) + 4 mg dexamethasone (1 ml) in QL plane on the operated side using ultrasound, after completion of surgery under spinal anaesthesia. The primary objective was to compare time for first rescue analgesia. The secondary objectives were total rescue analgesic consumption and numeric rating scale (NRS) in the first 24 h.
Results


The demographic data age, sex, height, weight and ASA were comparable in both groups. The mean time to request for first rescue analgesia was longer in group D compared to group L (1016.02 ± 205.97 min versus 640 ± 132.96 min;  P  < 0.0001). The mean total tramadol consumption in the first 24 h was lower in group D compared to group L (233.55 ± 86.92 mg versus 328.22 ± 78.74 mg;  P  < 0.0001). Patients in group D had significantly lower NRS scores at rest and on movement as compared to group L.
Conclusions


The addition of dexamethasone to levobupivacaine in QLB results in prolonged duration of postoperative analgesia, less rescue analgesic requirements and better quality of analgesia as compared to levobupivacaine in unilateral inguinal hernia repair surgery.",2020,The mean time to request for first rescue analgesia was longer in group D compared to group L (1016.02 ± 205.97 min versus 640 ± 132.96 min;  P  < 0.0001).,"['90 patients of American Society of Anaesthesiologists (ASA', 'patients undergoing unilateral inguinal hernia repair', 'patients undergoing unilateral inguinal hernia repair surgery', 'unilateral inguinal hernia repair surgery']","['levobupivacaine (20 ml) + normal saline', '\n\n\nQuadratus lumborum block (QLB', 'dexamethasone', 'levobupivacaine (20 ml) + 4 mg dexamethasone', 'levobupivacaine', 'dexamethasone with levobupivacaine']","['analgesic effect', 'rescue analgesic requirements and better quality of analgesia', 'quadratus lumborum block', 'time for first rescue analgesia', 'mean total tramadol consumption', 'NRS scores', 'mean time to request for first rescue analgesia', 'total rescue analgesic consumption and numeric rating scale (NRS) in the first 24 h.\nResults\n\n\nThe demographic data age, sex, height, weight and ASA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]",,0.201156,The mean time to request for first rescue analgesia was longer in group D compared to group L (1016.02 ± 205.97 min versus 640 ± 132.96 min;  P  < 0.0001).,"[{'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Singariya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Satya Narayan', 'Initials': 'SN', 'LastName': 'Seervi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Government Medical College, Pali, Rajasthan, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Bihani', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Dr S N Medical College, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Mritunjay', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, Critical Care and Pain Medicine, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_159_20']
2701,32934401,Influence of head and neck positions on oropharyngeal seal pressure with Baska mask ®  versus I-gel™; A randomised clinical study.,"Background and Aims


Oropharyngeal seal pressure (OSP) achieved by a supraglottic airway device holds due importance as it indicates the feasibility of positive pressure ventilation, the degree of airway protection from supra-cuff soiling and also relates to postoperative morbidity. The primary outcome measure was to assess and compare OSP in different head and neck positions with Baska mask ®  and I-gel™. Secondary outcome measures were to compare peak inspiratory pressure (PIP), exhaled tidal volume (ETV), ease of insertion, time taken for insertion, number of attempts, intraoperative manipulations, and postoperative airway morbidity with both the devices.
Materials and Methods


Seventy consenting adults scheduled for a variety of surgical procedures under general anesthesia were allocated to Group B and Group G using Baska mask ®  and I-gel™ respectively. All statistical calculations were done using SPSS (Statistical Package for the Social Science). The comparison of quantitative variables between the study groups was done using Student  t -test and within the variables was done by paired  t -test. For comparing categorical data, Chi-square (χ 2 ) test was performed.
Results


OSP was significantly higher in group B than in group G in all head and neck positions (neutral 33 ± 2.8 vs. 23.2 ± 1.8, flexion 35.5 ± 2.5 vs. 25.2 ± 1.6, extension 30.6 ± 2.7 vs. 21.4 ± 1.7, right lateral 32.6 ± 2.8 vs. 23.0 ± 1.5. left lateral 32.6 ± 2.7 vs. 23.1 ± 1.7 cm H 2 O, respectively) ( P  = 0.000). PIP increased significantly in group G as compared to group B in flexion. ( P  = 0.009). Baska mask ®  had significantly higher ETV in flexion compared to I-gel™. ( P  = 0.009).
Conclusion


Baska mask ®  may provide a useful alternative to I-gel™ where the glottic seal has precedence over ease of insertion.",2020,"Results


OSP was significantly higher in group B than in group G in all head and neck positions (neutral 33 ± 2.8 vs. 23.2 ± 1.8, flexion 35.5 ± 2.5 vs. 25.2 ± 1.6, extension 30.6 ± 2.7 vs. 21.4 ± 1.7, right lateral 32.6 ± 2.8 vs. 23.0 ± 1.5.",['Seventy consenting adults scheduled for a variety of surgical procedures under general anesthesia'],"['Baska mask ®  versus I-gel™', 'Oropharyngeal seal pressure (OSP', 'Baska mask ®  and I-gel™ respectively']","['oropharyngeal seal pressure', 'PIP', 'OSP in different head and neck positions with Baska mask ®  and I-gel™', 'OSP', 'peak inspiratory pressure (PIP), exhaled tidal volume (ETV), ease of insertion, time taken for insertion, number of attempts, intraoperative manipulations, and postoperative airway morbidity with both the devices', 'ETV in flexion']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1301933', 'cui_str': 'Airway morbidity'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",70.0,0.101598,"Results


OSP was significantly higher in group B than in group G in all head and neck positions (neutral 33 ± 2.8 vs. 23.2 ± 1.8, flexion 35.5 ± 2.5 vs. 25.2 ± 1.6, extension 30.6 ± 2.7 vs. 21.4 ± 1.7, right lateral 32.6 ± 2.8 vs. 23.0 ± 1.5.","[{'ForeName': 'Gurkaran Kaur', 'Initials': 'GK', 'LastName': 'Sidhu', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Jindal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Rupali', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Bhagat', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_185_20']
2702,32934402,Comparison of glottic visualisation through supraglottic airway device (SAD) using bronchoscope in the ramped versus supine 'sniffing air' position: A pilot feasibility study.,"Background and Aims


Airway management in obese patients is associated with increased risk of difficult airway and intubation. After failed intubation, supraglottic airway-guided flexible bronchoscopic intubation (SAGFBI) may be required. It is uncertain whether SAGFBI is best performed in the ramped versus conventional supine ""sniffing air"" position. We conducted a feasibility study to evaluate the logistics of positioning, compared glottic views, and evaluated SAGFBI success rates.
Methods


We conducted a prospective, pilot study in patients with a body mass index (BMI) 30-40 kg/m 2  undergoing elective operations requiring tracheal intubation. All patients were placed in a ramped position. After induction, a supraglottic airway device (SAD) was inserted. A flexible bronchoscope was inserted into the SAD and a photograph of the glottic view taken. The patient was repositioned to the supine position. A second photograph was taken. SAGFBI was performed. Images were randomised and assessed by two independent anesthetists.
Results


Of 17 patients recruited, 15 patients were repositioned successfully. There were no differences in glottic views observed in the two positions. SAGFBI was successful in 92.9% of patients (median time 91.5 s). Haemodynamic changes were noted in 42.7% of patients which resolved spontaneously.
Conclusion


Our pilot study was completed within 5 months, achieved low dropout rate and protocol feasibility was established. SAGFBI was successfully and safely performed in obese patients, with a median time of 91.5 s. The time taken for SAGFBI was similar to awake intubation using FBI and videolaryngoscopy. Our study provided preliminary data supporting future, larger-scale studies to evaluate glottic views in the ramped versus supine positions.",2020,There were no differences in glottic views observed in the two positions.,"['obese patients', 'patients with a body mass index (BMI) 30-40 kg/m 2  undergoing elective operations requiring tracheal intubation', '17 patients recruited, 15 patients were repositioned successfully']","['supraglottic airway-guided flexible bronchoscopic intubation (SAGFBI', 'glottic visualisation through supraglottic airway device (SAD', 'supraglottic airway device (SAD']","['Haemodynamic changes', 'time taken for SAGFBI', 'glottic views']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}]","[{'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0449911', 'cui_str': 'View'}]",15.0,0.0515741,There were no differences in glottic views observed in the two positions.,"[{'ForeName': 'Wan Yen', 'Initials': 'WY', 'LastName': 'Lim', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fook-Chong', 'Affiliation': 'Department of Health Services Research, Singapore General Hospital, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesiology, Singapore General Hospital, Singapore.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_320_20']
2703,32934403,"A pilot randomised clinical trial comparing desflurane anaesthesia vs total intravenous anaesthesia, for changes in haemodynamic, inflammatory and coagulation parameters in patients undergoing hyperthermic intraperitoneal chemotherapy.","Background and Aims


Cytoreduction and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) cause numerous pathophysiological changes. The objective of this study was to compare the effect of two anaesthetic techniques on haemodynamic changes, inflammatory and coagulation parameters during this procedure.
Methods


Twenty-one consenting adults undergoing CRS+HIPEC procedure, were block randomised to receive desflurane (V,  n  = 9) or TIVA (T,  n  = 12). After epidural catheter placement and intravenous induction of anaesthesia in both groups with fentanyl, propofol and rocuronium, anaesthesia was maintained with propofol or with desflurane, based on group allocation. Haemodynamic and temperature changes were assessed intra-operatively and variance was analysed. Inflammatory and coagulation markers were measured and compared at five time-points in the peri-operative period. Categorical variables were analysed using Chi square or Fisher exact test. Continuous variables were compared using  t -test or Wilcoxon rank sum test.
Results


Changes in core body temperature and haemodynamic variables during the hyperthermic intraperitoneal chemotherapy (HIPEC) phase were comparable between the two groups; except mean variance of mean arterial pressure, which was significantly higher ( P  = 0.0056) in group V (receiving desflurane) (58.98 ± 36.74) than TIVA group (27.51 ± 14.22). Inflammatory markers in both groups were comparable at five defined time points in the peri-operative period. On post-hoc analysis, pairwise comparisons with baseline, between levels of inflammatory markers within each group showed increased post-operative inflammation in group V. Mean prothrombin time was comparable.
Conclusion


Desflurane group suffered greater mean arterial pressure (MAP) instability during the HIPEC phase. Inflammation in both groups was highest during the first 24 h after surgery. Prolonged inflammation was noted in patients receiving desflurane.",2020,"After epidural catheter placement and intravenous induction of anaesthesia in both groups with fentanyl, propofol and rocuronium, anaesthesia was maintained with propofol or with desflurane, based on group allocation.","['patients undergoing hyperthermic intraperitoneal chemotherapy', 'Methods\n\n\nTwenty-one consenting adults undergoing CRS+HIPEC procedure']","['desflurane anaesthesia vs total intravenous anaesthesia', 'hyperthermic intraperitoneal chemotherapy (CRS+HIPEC', 'fentanyl, propofol and rocuronium, anaesthesia', 'desflurane (V,  n  = 9) or TIVA', 'Desflurane', 'propofol or with desflurane', 'desflurane']","['haemodynamic, inflammatory and coagulation parameters', 'Inflammatory markers', 'Inflammation', 'Inflammatory and coagulation markers', 'mean arterial pressure (MAP) instability', 'haemodynamic changes, inflammatory and coagulation parameters', 'Mean prothrombin time', 'core body temperature and haemodynamic variables', 'Haemodynamic and temperature changes', 'Prolonged inflammation', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C3665472', 'cui_str': 'Chemotherapy'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}]","[{'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]",21.0,0.0809695,"After epidural catheter placement and intravenous induction of anaesthesia in both groups with fentanyl, propofol and rocuronium, anaesthesia was maintained with propofol or with desflurane, based on group allocation.","[{'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Pandit', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sachidanand J', 'Initials': 'SJ', 'LastName': 'Bharati', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Suryanarayana Vs', 'Initials': 'SV', 'LastName': 'Deo', 'Affiliation': 'Department of Surgical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_34_20']
2704,32934404,Comparative evaluation of oral melatonin and oral clonidine for the attenuation of haemodynamic response to laryngoscopy and tracheal intubation-A prospective randomised double blind study.,"Background and Aims


Laryngoscopy and endotracheal intubation cause significant derangement of the haemodynamic parameters proving detrimental for some patients. Clonidine, an α-2 adrenoreceptor agonist, and melatonin, the pineal hormone, have been used for the attenuation of these haemodynamic responses. This study was designed to evaluate the effect of oral melatonin and clonidine in attenuating the haemodynamic responses to laryngoscopy and intubation.
Materials and Methods


In this prospective randomised double-blind study, 60 American Society of Anaesthesiologists (ASA) grade I and II patients aged 20-60 years of either gender scheduled to undergo elective surgery under general anaesthesia were randomly divided into Group M and Group C and orally received 6 mg of melatonin and 0.2 mg of clonidine, respectively, 120 min before the induction of anaesthesia. The haemodynamic parameters-heart rate (HR), systolic blood pressure, diastolic blood pressure, mean arterial pressure and rate -pressure product(RPP) were recorded before and 120 min after the administration of the study drug, before induction, immediately after intubation and at 1, 3, 5 and 10 min following intubation. Sedation was assessed using the Ramsay Sedation Scale. The qualitative and quantitative variables were analysed using Chi square test and unpaired student t test, respectively. For intragroup comparison of quantitative data, paired t test was applied. A  P  value <0.05 was considered as statistically significant.
Results


A significant difference was noted between the groups regarding HR and RPP 0, 1, 3 and 5 min after intubation. The Ramsay sedation score ranged between 2 and 3 at all time intervals.
Conclusion


Although both the drugs are effective, oral melatonin proved superior to oral clonidine in attenuating the haemodynamic response to laryngoscopy and tracheal intubation without any side effects.",2020,"A significant difference was noted between the groups regarding HR and RPP 0, 1, 3 and 5 min after intubation.",['60 American Society of Anaesthesiologists (ASA) grade I and II patients aged 20-60 years of either gender scheduled to undergo elective surgery under general anaesthesia'],"['oral melatonin and oral clonidine', 'oral melatonin and clonidine', 'Clonidine', 'melatonin and 0.2 mg of clonidine', 'clonidine']","['Ramsay Sedation Scale', 'haemodynamic response', 'Ramsay sedation score', 'haemodynamic parameters-heart rate (HR), systolic blood pressure, diastolic blood pressure, mean arterial pressure and rate -pressure product(RPP']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",60.0,0.101668,"A significant difference was noted between the groups regarding HR and RPP 0, 1, 3 and 5 min after intubation.","[{'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan, India.'}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Kumari', 'Affiliation': 'Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan, India.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Kalluraya', 'Affiliation': 'Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan, India.'}, {'ForeName': 'Khemraj', 'Initials': 'K', 'LastName': 'Meena', 'Affiliation': 'Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan, India.'}, {'ForeName': 'Tanuj', 'Initials': 'T', 'LastName': 'Dave', 'Affiliation': 'Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_76_20']
2705,32934405,A randomised preliminary study to compare the performance of fibreoptic bronchoscope and laryngeal mask airway CTrach (LMA CTrach) for visualisation of laryngeal structures at the end of thyroidectomy.,"Background and Aims


Various methods have been used to check vocal cord movements as a routine before awakening the patient at the end of thyroidectomy to rule out recurrent laryngeal nerve (RLN) palsy; out of which, fibreoptic-assisted visualisation via laryngeal mask airway (LMA) being the most desirable.
Methods


Thirty patients of either sex, aged 18-65 years, American Society of Anaesthesiologists (ASA) grade I/II, scheduled for thyroidectomy under general anaesthesia (GA) were included and were randomised to receive either fibreoptic assisted (FB) or LMA CTrach-assisted (CT) visualisation of laryngeal structures at the end of thyroidectomy. The primary outcome was grade of view of laryngeal structures and secondary outcomes were time taken to achieve optimal view of laryngeal structures, ease of visualisation, hemodynamic parameters, and complications.
Results


In the fibreoptic group, we obtained comparable optimal laryngeal view i.e., grade 1 and 2 in all (100%) patients in comparison to 14 (93.33%) in LMA CTrach group. The ""time taken to achieve the optimal view"" was significantly lower in the CTrach group when compared to Fibreoptic group (220.67 ± 95.98 vis-a-vis 136.67 ± 68.98). The ease of visualisation of laryngeal structures was comparable ( P  = 0.713) and the baseline haemodynamic parameters were comparable between the 2 groups and at various designated intervals. In total, 6.66% and 26.66% patients in group FB and CT group, respectively, required manoeuvres. However, difference was statistically significant ( P  < 0.05).
Conclusion


Both Fibreoptic-assisted and LMA CTrach-assisted visualization of laryngeal structures in thyroidectomy are equally efficacious in terms of the optimal laryngeal view obtained and ease of visualisation. However, the time taken to achieve optimal laryngeal view was lesser with LMA CTrach.",2020,"The ""time taken to achieve the optimal view"" was significantly lower in the CTrach group when compared to Fibreoptic group (220.67 ± 95.98 vis-a-vis 136.67 ± 68.98).","['Thirty patients of either sex, aged 18-65 years, American Society of Anaesthesiologists (ASA) grade I/II, scheduled for thyroidectomy under general anaesthesia (GA']","['fibreoptic-assisted visualisation via laryngeal mask airway (LMA', 'fibreoptic assisted (FB) or LMA CTrach-assisted (CT) visualisation of laryngeal structures at the end of thyroidectomy', 'fibreoptic bronchoscope and laryngeal mask airway CTrach (LMA CTrach']","['ease of visualisation of laryngeal structures', 'grade of view of laryngeal structures and secondary outcomes were time taken to achieve optimal view of laryngeal structures, ease of visualisation, hemodynamic parameters, and complications', 'baseline haemodynamic parameters', 'time taken to achieve the optimal view']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0179433', 'cui_str': 'Flexible bronchoscope'}]","[{'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0399401,"The ""time taken to achieve the optimal view"" was significantly lower in the CTrach group when compared to Fibreoptic group (220.67 ± 95.98 vis-a-vis 136.67 ± 68.98).","[{'ForeName': 'Geetanjali T', 'Initials': 'GT', 'LastName': 'Chilkoti', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahdara, Delhi, India.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahdara, Delhi, India.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Mohta', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahdara, Delhi, India.'}, {'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahdara, Delhi, India.'}, {'ForeName': 'Chhavi S', 'Initials': 'CS', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahdara, Delhi, India.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anesthesiology and Critical Care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahdara, Delhi, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_138_20']
2706,32934540,Extended opening hours at nightclubs in Visby: An evaluation of a trial in the summer of 2014.,"Background and aims


During 10 weeks in the summer 2014 opening hours in nightclubs in Visby (Sweden) were extended by 1 hour, postponing the permitted closing time from 2 to 3 a.m. A number of preventive efforts such as Responsible Server Training, and an intensified cooperation between the police and the nightclubs were strengthened in connection with the trial. The aim of this study was to evaluate the impact of this trial on police-reported violence.
Data and methods


To estimate the effect of the trial on violence, we compared the violence rate during the intervention period (week 24-week 33, 2014) with the violence rate in the corresponding period in Visby in 2010-2013. The intervention period thus comprised 10 weeks, and the pre-intervention period 40 weeks. As outcome measure we chose police-reported assaults that had occurred at night (midnight-6 a.m.). As control series we used assaults daytime (6 a.m.-midnight). The intervention effect was estimated with the method of ""difference in differences"" (DiD). Interviews with key informants provided the study with an explanatory context for the trial outcomes.
Results


The intervention effect was strongly statistically significant with a reduction of 3.336 reported assaults at night per week compared to the pre-intervention period. This represents a decrease of 71%.
Conclusion


The trial with an extension of opening hours at nightclubs in Visby was followed by a reduction in police-reported violence. This unexpected outcome is likely to be the result of (i) the simultaneous strengthening of efficient preventive measures, and (ii) a decreased congestion in the streets resulting from increased spread in closing hours.",2018,The intervention effect was strongly statistically significant with a reduction of 3.336 reported assaults at night per week compared to the pre-intervention period.,[],['Extended opening hours at nightclubs in Visby'],['violence rate'],[],"[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0442567', 'cui_str': 'Nightclub'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}]",,0.0332813,The intervention effect was strongly statistically significant with a reduction of 3.336 reported assaults at night per week compared to the pre-intervention period.,"[{'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Norström', 'Affiliation': 'Stockholm University, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ramstedt', 'Affiliation': 'Swedish Council for Information on Alcohol and Other Drugs (CAN), Stockholm, Sweden Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Svensson', 'Affiliation': 'Swedish Council for Information on Alcohol and Other Drugs (CAN), Stockholm, Sweden Karolinska Institutet, Stockholm, Sweden.'}]",Nordisk alkohol- & narkotikatidskrift : NAT,['10.1177/1455072518784850']
2707,32934619,"Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth.","Objective


To compare the anesthetic performances of 3% prilocaine and 4% articaine when used for the extraction of the maxillary teeth.
Materials and Methods


Ninety-five patients, aged between 16 and 70 years, were included in this study. Patients were divided into two groups. Group one received articaine 4% with 1:00.000 adrenaline. Group two received prilocaine with 3% felypressin (0.03 I.U. per ml). Onset time of anesthesia was objectively evaluated by using electronic pulp testing.
Results


Eighty-five patients in this study had a successful local anesthetic followed by extraction within the study duration time (10 minutes). However, there were six patients with failure anesthesia (5 in prilocaine group and 1 in articaine group). By applying Person's Chi-square test (x2), there were no significant differences in the number of episodes of the anesthetic success between articaine and prilocaine groups at time intervals ( P  = 0.5). T-test showed that there have been no important variations within the mean onset time of anesthesia for articaine and prilocaine buccal infiltrations ( P  = 0.1).
Conclusions


3% Prilocaine with felypressin is as effective as 4% articaine with adrenaline when used for the extraction of maxillary teeth. Recommendations would be given to the dental practitioners to use prilocaine more frequently than articaine because of its low toxicity.
Trial registration number


NCT04236115.",2020,"T-test showed that there have been no important variations within the mean onset time of anesthesia for articaine and prilocaine buccal infiltrations ( P  = 0.1).
","['Materials and Methods\n\n\nNinety-five patients, aged between 16 and 70 years', 'Eighty-five patients in this study had a successful local anesthetic followed by extraction within the study duration time (10 minutes']","['prilocaine and 4% articaine', 'articaine 4% with 1:00.000 adrenaline', 'felypressin', 'adrenaline', 'prilocaine with 3% felypressin', 'articaine', 'prilocaine', 'Prilocaine']","['anesthetic performances', 'success rate of anaesthesia', 'number of episodes of the anesthetic success']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0015777', 'cui_str': 'Felypressin'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",6.0,0.111317,"T-test showed that there have been no important variations within the mean onset time of anesthesia for articaine and prilocaine buccal infiltrations ( P  = 0.1).
","[{'ForeName': 'Giath', 'Initials': 'G', 'LastName': 'Gazal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Taibah University, College of Dentistry, Madinah Al- Munawwarah, Saudi Arabia.'}]",Saudi journal of anaesthesia,['10.4103/sja.SJA_94_20']
2708,32934660,Evoking the Withdrawal Reflex via Successive Needle-Pricking on the Plantar and Dorsal Aspect of the Foot Increases the FMA of the Lower Limb for Poststroke Patients in Brunnstrom Stage III: A Preliminary Study.,"The withdrawal reflex is a defensive reaction to nociceptive stimuli and can be used to regulate locomotor gait during rehabilitation. We investigated the effect of successive needle-pricking of the plantar and dorsal foot surfaces on poststroke lower limb function. Thirty-five hemiplegic patients, within one month after primary stroke, with an affected lower limb (Brunnstrom stage III) were randomly divided into intervention and control groups. Both groups received routine drug treatment, rehabilitation training, and upper limb acupuncture treatment on the hemiplegic side. The control group also received routine acupuncture on the hemiplegic side of the lower limb, while the intervention group received successive needle-pricking on the sole and instep of both the unaffected and affected side feet. Outcomes were assessed before inception (D0) and after three (D3) and six (D6) treatment days, using Brunnstrom stage (Ueda assessment), total Fugl-Meyer lower extremity assessment (FMA-LE) and its subscores (FMA-LE-ss), active lower limb range of motion (AROM-LL), Modified Ashworth Scale Score (MAS-LL), and manual muscle testing (MMT-LL). The Brunnstrom stage was better in the intervention group than in the control group at both D3 and D6 ( P  < 0.01). The total FMA-LE score and sections B, C, D, and G FMA-LE-ss were significantly better in the intervention group than in the control group at D3 and D6 ( P  < 0.05). The AROM-LL hip and knee flexion and hip extension improved more in the intervention group than in the control group ( P  < 0.05). In the intervention group, MAS-LL hip flexion significantly improved at D6 ( P  < 0.01). Improvement in lower limb joints on the MMT-LL in the intervention group exceeded that in the control group at D6 ( P  < 0.01). Successive needle-pricking on the plantar and dorsal foot aspects of Brunnstrom stage III in poststroke patients contributed to rapid lower limb motor function improvement via the withdrawal reflex. This trial is registered with ChiCTR1900020633.",2020,The AROM-LL hip and knee flexion and hip extension improved more in the intervention group than in the control group ( P  < 0.05).,"['poststroke patients', 'Thirty-five hemiplegic patients, within one month after primary stroke, with an affected lower limb (Brunnstrom stage III']","['Successive needle-pricking', 'routine drug treatment, rehabilitation training, and upper limb acupuncture treatment', 'successive needle-pricking', 'Withdrawal Reflex via Successive Needle-Pricking', 'routine acupuncture', 'successive needle-pricking of the plantar and dorsal foot surfaces']","['MAS-LL hip flexion', 'MMT-LL', 'total FMA-LE score and sections B, C, D, and G FMA-LE-ss', 'Brunnstrom stage (Ueda assessment), total Fugl-Meyer lower extremity assessment (FMA-LE) and its subscores (FMA-LE-ss), active lower limb range of motion (AROM-LL), Modified Ashworth Scale Score (MAS-LL), and manual muscle testing (MMT-LL', 'AROM-LL hip and knee flexion and hip extension', 'lower limb joints']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0277847', 'cui_str': 'Flexion spinal defense reflex'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0003805', 'cui_str': 'Androstenedione Aromatase'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",35.0,0.016472,The AROM-LL hip and knee flexion and hip extension improved more in the intervention group than in the control group ( P  < 0.05).,"[{'ForeName': 'Cui-Cui', 'Initials': 'CC', 'LastName': 'Shen', 'Affiliation': ""Department of Acupuncture and Moxibustion, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi 214000, Jiangsu Province, China.""}, {'ForeName': 'Kuok-Tong', 'Initials': 'KT', 'LastName': 'Lei', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China.'}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yizheng Hospital of Traditional Chinese Medicine, Yizheng 211400, Jiangsu Province, China.'}, {'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Xiong', 'Affiliation': 'The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210017, Jiangsu Province, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/3805628']
2709,32934661,Chinese Herbal Formula Xuefu Zhuyu for Stable Angina (CheruSA): Study Protocol for a Multicenter Randomized Controlled Trial.,"Introduction.  Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient's quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA.  Methods and Analysis.  This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs.  Ethics and Dissemination.  The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.",2020,"Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care.","['SA patients', 'CheruSA', '152 eligible participants', 'registered on 26 October 2019']","['XFZY', 'placebo plus routine care', 'XFZY plus routine care', 'Chinese herbal formula Xuefu Zhuyu (XFZY']","['angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs', 'efficacy and safety', 'change in visual analogue scale score for angina pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C1956470', 'cui_str': 'Xuefu Zhuyu'}]","[{'cui': 'C0235462', 'cui_str': 'Anginal attack'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0577698', 'cui_str': 'Exercise-induced angina'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",152.0,0.256632,"Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care.","[{'ForeName': 'Shaojun', 'Initials': 'S', 'LastName': 'Liao', 'Affiliation': 'Second Clinical Medical College (Second Affiliated Hospital), Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, Shenyang 110847, China.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical Medical College (Second Affiliated Hospital), Guangzhou University of Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Cardiovascular Department, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Cardiovascular Department, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cardiovascular Department, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Cardiovascular Department, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China.'}, {'ForeName': 'Zehuai', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/7612721']
2710,32934688,Efficacy of procaine combined with ketamine and propofol in pediatric epidural anesthesia.,"In the present study, the effect of procaine combined with ketamine and propofol in pediatric epidural anesthesia was analyzed. A total of 74 children scheduled to undergo surgery under epidural anesthesia were included in the study, and were divided into two groups using a random number table. Accordingly, 37 patients received epidural anesthesia using ketamine and propofol (control group), whereas the remaining patients received procaine combined with ketamine and propofol (observation group). The vital signs, sedative effects, anesthetic effects, pain intensity, anesthetic dose and incidence of adverse reactions were compared between the groups. It was revealed that the heart rate and mean arterial pressure at T4 (following epidural administration) in the observation group was significantly lower compared with those of the control group (P<0.05). However, no statistical difference was observed in the proportion of patients with sedation at Ramsay levels 1-6 between the observation and the control group (P>0.05). Compared with the control group, the observation group reported a shorter latent period for the onset of the anesthetic effect and the disappearance of pain, and a longer period for the recovery of pain sensation (P<0.05). The observation group exhibited prominently lower visual analog scale scores at 6, 12, 18 and 24 h post-surgery compared with the control group (P<0.05). Additionally, the observation group received a lower dose of ketamine and propofol compared with the control group (P<0.05). An incidence of adverse reactions of 8.11% was noted in the observation group during the surgery and anesthesia recovery period, which was lower compared with that of the control group (29.73%) (P<0.05). The results of the present study indicated that the combination of procaine with ketamine and propofol in pediatric epidural anesthesia may be more commonly employed, considering its advantages in accelerating the anesthesia process, improving the anesthetic effects and guaranteeing anesthesia safety. However, only a few indicators of the anesthesia efficacy and a small group of patients were included in the present study, and a long-term comprehensive analysis using a larger sample size is required to address this issue.",2020,"The observation group exhibited prominently lower visual analog scale scores at 6, 12, 18 and 24 h post-surgery compared with the control group (P<0.05).","['74 children scheduled to undergo surgery under epidural anesthesia', 'pediatric epidural anesthesia', '37 patients received']","['procaine combined with ketamine and propofol (observation group', 'epidural anesthesia using ketamine and propofol', 'ketamine and propofol', 'procaine combined with ketamine and propofol']","['disappearance of pain', 'recovery of pain sensation', 'adverse reactions', 'heart rate and mean arterial pressure', 'vital signs, sedative effects, anesthetic effects, pain intensity, anesthetic dose and incidence of adverse reactions', 'visual analog scale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033218', 'cui_str': 'Procaine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",74.0,0.0352206,"The observation group exhibited prominently lower visual analog scale scores at 6, 12, 18 and 24 h post-surgery compared with the control group (P<0.05).","[{'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, P.R. China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, P.R. China.'}, {'ForeName': 'Zijun', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesiology, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, Xi'an, Shaanxi 710054, P.R. China.""}, {'ForeName': 'Xucai', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, Xi'an, Shaanxi 710054, P.R. China.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9151']
2711,32934703,Predictive value and changes of miR-34a after concurrent chemoradiotherapy and its association with cognitive function in patients with nasopharyngeal carcinoma.,"This study explored the changes and predictive value of miR-34a in nasopharyngeal carcinoma (NPC) after concurrent chemoradiotherapy (CCRT), and its association with cognitive function. Fifty NPC patients admitted to Shunde Hospital, and another fifty healthy individuals were assigned into treated group and control group, respectively. Patients in the treated group received 3 courses of CCRT. The relative expression of miR-34a in the two groups was detected, and the cognitive function of patients was assessed. Diagnostic and predictive values of miR-34a in advanced NPC were analyzed. The expression of miR-34a in the control group was significantly higher than that in the treated group (t=13.364, P<0.001), with an area under the curve (AUC) of 0.979. The expression of miR-34a was significantly upregulated after treatment (t=4.559, P<0.001). After treatment, there were 32 complete remission (CR) patients and 18 partial remission (PR) patients. According to efficacy, CR patients were classified as significant group and PR patients as general group. The expression of miR-34a in the significant group was higher than that in the general group before treatment (t=4.704, P<0.001), with an AUC of 0.852. The Montreal Cognitive Assessment (MoCA) score was significantly decreased after treatment (t=13.042, P<0.001). The expression of miR-34a was positively correlated with the MoCA score after treatment, that is, MoCA score gradually increased with the upregulation of miR-34a expression (r=0.379, P=0.006). There is a positive correlation between miR-34a and cognitive function of patients. Moreover, the expression of miR-34a can be used as a potential predictor of the efficacy of CCRT in patients with NPC.",2020,"The expression of miR-34a was significantly upregulated after treatment (t=4.559, P<0.001).","['patients with NPC', 'patients with nasopharyngeal carcinoma', 'Fifty NPC patients admitted to Shunde Hospital, and another fifty healthy individuals']","['CCRT', 'concurrent chemoradiotherapy (CCRT']","['Montreal Cognitive Assessment (MoCA) score', 'relative expression of miR-34a', 'miR-34a expression', 'MoCA score', 'expression of miR-34a']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}]",50.0,0.0209135,"The expression of miR-34a was significantly upregulated after treatment (t=4.559, P<0.001).","[{'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Neurology, Shunde Hospital, Guangzhou University of Traditional Chinese Medicine, Foshan, Guangdong 528300, P.R. China.'}, {'ForeName': 'Anqi', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Department of Pneumology, Shunde Hospital, Guangzhou University of Traditional Chinese Medicine, Foshan, Guangdong 528300, P.R. China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Shunde Hospital, Guangzhou University of Traditional Chinese Medicine, Foshan, Guangdong 528300, P.R. China.'}]",Oncology letters,['10.3892/ol.2020.11995']
2712,32934794,Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial.,"Background:  Delirium is a common and serious complication of major surgery for older adults. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  Methods:  This will be a randomized, controlled, factorial pilot trial at a large academic medical center. High-risk, non-cardiac surgery patients (≥70 years old) will be recruited. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system (n=15). The primary outcome will be the presence of delirium, defined by positive long-form Confusion Assessment Method screening. Secondary outcomes will include additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures. Exploratory outcomes include the incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates.  Ethics and dissemination:  This trial has received approval by the University of Michigan Medical Institutional Review Board (IRBMED). Dissemination plans include presentation at scientific conferences, publication in medical journals, and distribution via educational and news media.  Registration:  ClinicalTrials.gov Identifier NCT04007523, registered on 7/3/2019.",2019,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","['older adults', 'patient-care programs and family members for high-risk patients', 'High-risk, non-cardiac surgery patients (≥70 years old']","['usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system']","['incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates', 'presence of delirium, defined by positive long-form Confusion Assessment Method screening', 'additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3874055', 'cui_str': 'Paging system'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.190457,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","[{'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Vlisides', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Jacqueline W', 'Initials': 'JW', 'LastName': 'Ragheb', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Aleda', 'Initials': 'A', 'LastName': 'Leis', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Schoettinger', 'Affiliation': 'Department of Social Work, Michigan Medicine, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hickey', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McKinney', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Zierau', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Norcott', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}]",F1000Research,['10.12688/f1000research.20597.2']
2713,32934804,"Analgesic efficacy of intravenous nefopam after spine surgery: a randomized, double-blind, placebo-controlled trial.","Background   :  The incidence of moderate to severe pain is high among patients undergoing spinal surgery. Nefopam can be used as an adjuvant analgesic postoperatively after spine surgery. The study aimed to assess the analgesic efficacy and side effects of nefopam on 24-hour postoperative morphine consumption after spine surgery.  Methods   :  The study is a randomized, double-blinded, placebo-controlled trial. A total of 96 patients were randomized into 4 treatment groups, 24 each. In group 1, patients received normal saline before surgical incision and before the end of surgery. In group 2, patients received 30 mg nefopam before surgical incision and normal saline before the end of surgery. In group 3, patients received normal saline before surgical incision and 30 mg of nefopam before the end of surgery. In group 4, patients received 30 mg of nefopam in both timings. Patient-controlled analgesia morphine was used for the postoperative period. Outcomes were to determine 24-hour morphine consumption and incidence of side effects.   Results   :  Of 96 patients enrolled, 21 in placebo-placebo, 22 in nefopam-placebo, 22 in placebo-nefopam and 21 in nefopam-nefopam groups completed the study. Analysis of the Kruskal-Wallis test shows no significant difference in 24-hour postoperative morphine consumption between four groups, which were 18 [IQR 13.5-29], 20 [IQR 11-28.3], 17 [IQR 11.5-28.5], 13 [IQR 8.5-18.5] mg., respectively (p = 0.223).  Incidence of side effects, including tachycardia, sedation, sweating and nausea/ vomiting, did not differ.  Conclusions   :  Adding perioperative nefopam to opioid analgesic does not improve analgesic efficacy in patients who underwent spine surgery.  Registration   :  Thai Clinical Trials Registry ID TCTR20171115001; registered on 15 November 2017.",2020,"Incidence of side effects, including tachycardia, sedation, sweating and nausea/ vomiting, did not differ.  ","['after spine surgery', 'patients who underwent spine surgery', ' 22 in nefopam-placebo, 22 in placebo-nefopam and 21 in nefopam-nefopam groups completed the study', '96 patients', '96 patients enrolled, 21 in', 'patients undergoing spinal surgery']","['intravenous nefopam', '30 mg nefopam before surgical incision and normal saline', 'normal saline before surgical incision and 30 mg of nefopam', 'placebo', 'normal saline', 'nefopam', 'placebo-placebo']","['24-hour postoperative morphine consumption', 'Incidence of side effects, including tachycardia, sedation, sweating and nausea/ vomiting', 'analgesic efficacy', 'Analgesic efficacy', '24-hour morphine consumption and incidence of side effects']","[{'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0027556', 'cui_str': 'Nefopam'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",96.0,0.598537,"Incidence of side effects, including tachycardia, sedation, sweating and nausea/ vomiting, did not differ.  ","[{'ForeName': 'Jatuporn', 'Initials': 'J', 'LastName': 'Eiamcharoenwit', 'Affiliation': 'Department of Anesthesiology, Prasat Neurological Institute, 312, Ratchawithi Road, Thung Phaya Thai, Ratchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Haruthai', 'Initials': 'H', 'LastName': 'Chotisukarat', 'Affiliation': 'Department of Anesthesiology, Prasat Neurological Institute, 312, Ratchawithi Road, Thung Phaya Thai, Ratchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Tainil', 'Affiliation': 'Department of Anesthesiology, Prasat Neurological Institute, 312, Ratchawithi Road, Thung Phaya Thai, Ratchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nalinrat', 'Initials': 'N', 'LastName': 'Attanath', 'Affiliation': 'Department of Anesthesiology, Prasat Neurological Institute, 312, Ratchawithi Road, Thung Phaya Thai, Ratchathewi, Bangkok, 10400, Thailand.'}, {'ForeName': 'Phuping', 'Initials': 'P', 'LastName': 'Akavipat', 'Affiliation': 'Department of Anesthesiology, Prasat Neurological Institute, 312, Ratchawithi Road, Thung Phaya Thai, Ratchathewi, Bangkok, 10400, Thailand.'}]",F1000Research,['10.12688/f1000research.22909.2']
2714,32934865,Treatment of unstable extra-articular distal radius fractures using locked volar plating and percutaneous pinning without external fixation.,"INTRODUCTION


One of the most common fractions is distal radius fracture, and various treatments have been suggested for this. The purpose of this study, is comparison of Open reduction and internal fixation by using a locked volar plating compared to percutaneous pinning by cast immobilization under the elbow in patients less than 60 years with good bone density that had unstable extra-articular distal radius fracture or UDRF.
METHODS


This study was clinical trial. 88 patients with closed UDRF who were referred for surgical treatment entered the study. Patients were randomized into two groups: group 1 had open reduction and internal fixation by using a locked volar plating and the other group had percutaneous pinning by cast immobilization surgeries. Amount of pain [by using Visual analog scale or VAS] and functional results of two methods were compared 3 and 12 month after surgeries.
FINDINGS


The intensity of pain was higher in the pinning group 3 and 12 month after treatment (P=0.001 and P=0.390 respectively). The range of motions in the plating group was significantly better (P<0.001). There was a significant difference in performing daily activities 3 month after treatment between the two groups, but a significant limitation in daily activities, observed 12 months after surgery in pinning group (P=0.004).
CONCLUSION


Bone fixation, using locked volar plating, can be a better modality with regard to postsurgical pain and also the wrist range of motion than percutaneous pinning with cast immobilization in patients younger than 60 years sustaining unstable, closed extra-articular, distal radius fracture.",2020,The intensity of pain was higher in the pinning group 3 and 12 month after treatment (P=0.001 and P=0.390 respectively).,"['88 patients with closed UDRF who were referred for surgical treatment entered the study', 'patients less than 60 years with good bone density that had unstable extra-articular distal radius fracture or UDRF', 'patients younger than 60 years sustaining unstable, closed extra-articular, distal radius fracture']","['locked volar plating and percutaneous pinning without external fixation', 'open reduction and internal fixation by using a locked volar plating and the other group had percutaneous pinning by cast immobilization surgeries', 'Bone fixation', 'percutaneous pinning with cast immobilization', 'locked volar plating compared to percutaneous pinning by cast immobilization']","['intensity of pain', 'daily activities', 'performing daily activities', 'pain [by using Visual analog scale or VAS', 'range of motions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589036', 'cui_str': 'Skeletal fixation procedure'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",88.0,0.0273267,The intensity of pain was higher in the pinning group 3 and 12 month after treatment (P=0.001 and P=0.390 respectively).,"[{'ForeName': 'Saeid Sadeghi', 'Initials': 'SS', 'LastName': 'Joni', 'Affiliation': 'Department of Radiology, Razi Hospital, Guilan University of Medical Sciences Rasht, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Yavari', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, Isfahan University of Medical Sciences Isfahan, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Tavakoli', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Tavoosi', 'Affiliation': 'Department of Civil Engineering, School of Engineering, Islamic Azad University Khorasgan (Isfahan) Branch Isfahan, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Mohammadsharifi', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, Isfahan University of Medical Sciences Isfahan, Iran.'}]",International journal of burns and trauma,[]
2715,32934890,The consensus Immunoscore in phase 3 clinical trial (N0147) and impact on patient management decisions.,"The consensus Immunoscore is a routine assay quantifying the adaptive immune response within the tumor microenvironment. It has a prognostic value that has been confirmed in a phase 3 clinical trial (NCCTG N0147) in stage III colon cancers. Moreover, results from another phase 3 randomized trial revealed the predictive value of Immunoscore for response to adjuvant chemotherapy duration. These results highlight the clinical utility of Immunoscore. In its latest edition, the World Health Organization classification of Digestive System Tumors introduced for the first time the immune response as an essential and desirable diagnostic criterion for colorectal cancer. Within the tumor microenvironment, the immune response provides an important estimate of the risk of recurrence and death in colon cancer. The international validation of the prognostic value of the consensus Immunoscore together with its prognostic value in the N0147 trial and its predictive utility for response to chemotherapy in stage III patients provide valuable information for patient management.",2020,"Within the tumor microenvironment, the immune response provides an important estimate of the risk of recurrence and death in colon cancer.",[],[],[],[],[],[],,0.0335885,"Within the tumor microenvironment, the immune response provides an important estimate of the risk of recurrence and death in colon cancer.","[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Lanzi', 'Affiliation': 'INSERM, Laboratory of Integrative Cancer Immunology, Cordeliers Research Center, Paris, France.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Galon', 'Affiliation': 'INSERM, Laboratory of Integrative Cancer Immunology, Cordeliers Research Center, Paris, France.'}]",Oncoimmunology,['10.1080/2162402X.2020.1796003']
2716,32934904,Effect of simulation modules on Jordanian Nursing Student Knowledge and Confidence in Performing Critical Care Skills: A Randomized Controlled Trial.,"Background


Simulation is known to have a significant effect as a teaching strategy in nursing education. However, no studies have been conducted to examine the effect of simulation on nursing students' knowledge and confidence in performing critical care skills in Jordan .
Purpose


This study aimed to test the effect of simulation on university nursing students' knowledge and confidence in performing critical care skills for patients with cardiac, respiratory and neurological health problems.
Method


A randomized controlled (pre-test-post-test) design was implemented. The experimental group (n=38) attended 9 simulation scenarios, theoretical lectures and clinical training in hospital about cardiac, respiratory and neurological health problems, while the control group (n=38) attended only the theoretical lectures and clinical training in hospital. Knowledge and confidence were measured using knowledge exam and self-confidence scale respectively.
Results


A paired t-test indicated that mean knowledge and confidence regarding implementing critical care skills were significantly higher  P< 0.001  in the post-test than that in the pre-test, in both the experimental and the control group. However, independent t test revealed that the students in the experimental group scored significantly higher  P< 0.001  than control group in both knowledge and confidence regarding performing critical care skills.
Conclusion


Theoretical and clinical training is valuable teaching strategies that help enhance knowledge and confidence in applying critical care skills. However, adding simulation has a more significant effect than theoretical and clinical training in improving nursing students' knowledge and confidence in performing critical care nursing skills. Author strongly recommended considering simulation as alternative effective educational approach for clinical training especially during COVID-pandemic.",2020,"A paired t-test indicated that mean knowledge and confidence regarding implementing critical care skills were significantly higher  P< 0.001  in the post-test than that in the pre-test, in both the experimental and the control group.","['patients with cardiac, respiratory and neurological health problems', 'Jordanian Nursing Student Knowledge and Confidence in Performing Critical Care Skills', 'university nursing students']","['simulation modules', '9 simulation scenarios, theoretical lectures and clinical training in hospital about cardiac, respiratory and neurological health problems, while the control group (n=38) attended only the theoretical lectures and clinical training in hospital']",['mean knowledge and confidence regarding implementing critical care skills'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]",,0.0534543,"A paired t-test indicated that mean knowledge and confidence regarding implementing critical care skills were significantly higher  P< 0.001  in the post-test than that in the pre-test, in both the experimental and the control group.","[{'ForeName': 'Loai', 'Initials': 'L', 'LastName': 'Issa Tawalbeh', 'Affiliation': 'Faculty of Nursing, Al-AlBayt University, Al-Mafraq, P.O. Box: 130049. Postal code: 25113, Jordan.'}]",International journal of Africa nursing sciences,['10.1016/j.ijans.2020.100242']
2717,32934922,The Effect of Hirodoid Cream on Ecchymosis and Edema around Eyes after Rhinoplasty.,"BACKGROUND


Several methods have been used to decrease the periorbital edema and ecchymosis after rhinoplasty. In this study, we evaluated the efficacy of hirudoid and dexamethasone in reduction of the periorbital edema and ecchymosis.
METHODS


Sixty patients who underwent primary rhinoplasty were randomly divided into 3 groups. Group H received hirudoid cream, 3 times per day for 5 days from postoperative-day (POD). Group D received 10 mg of dexamethasone IV, immediately before surgery; and group C (control) received neither dexamethasone nor hirudoid. Two surgeons who were unaware of administered medications rated the severity of edema and intensity of ecchymosis, on 2 nd , 5 th , and 7 th  POD.
RESULTS


On 2 nd  POD, the edema in group D was significantly lower than groups H and C; but there was no significant difference in severity and intensity of ecchymosis between 3 groups. On 7 th  POD, the intensity of ecchymosis was significantly lower in group H in comparison to group C. When the difference between 2 nd  and 7 th  POD was evaluated, the resolution of severity of edema and intensity of ecchymosis was significantly better in group H ( p <0.001).
CONCLUSION


Hirudoid was shown to be effective in reducing edema and ecchymosis after rhinoplasty. The use of dexamethasone was effective in prevention of periorbital edema at early postoperative days, but it was not effective on resolution of ecchymosis.",2020,"On 7 th  POD, the intensity of ecchymosis was significantly lower in group H in comparison to group C.","['Ecchymosis and Edema around Eyes after Rhinoplasty', 'Sixty patients who underwent primary rhinoplasty']","['dexamethasone', 'hirudoid and dexamethasone', 'dexamethasone IV', 'Hirodoid Cream', 'dexamethasone nor hirudoid', 'hirudoid cream']","['intensity of ecchymosis', 'severity of edema and intensity of ecchymosis', 'severity and intensity of ecchymosis', 'periorbital edema and ecchymosis', 'resolution of ecchymosis', 'edema and ecchymosis', 'resolution of severity of edema and intensity of ecchymosis']","[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0062731', 'cui_str': 'Hirudoid'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0151205', 'cui_str': 'Periorbital edema'}]",60.0,0.0164349,"On 7 th  POD, the intensity of ecchymosis was significantly lower in group H in comparison to group C.","[{'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Rostami', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Shahid Modares Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Shahaboddin', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Shahid Modares Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Feizollah', 'Initials': 'F', 'LastName': 'Niazi', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Shahid Modares Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Karimi Rouzbahani', 'Affiliation': 'Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Nadri', 'Affiliation': 'Department of Surgery, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Mahmoudvand', 'Affiliation': 'Department of Surgery, Lorestan University of Medical Sciences, Khorramabad, Iran.'}]",World journal of plastic surgery,['10.29252/wjps.9.2.128']
2718,32934927,Comparison between Wrapping Dice Cartilage with Temporal Fascia and Wrapping in Alloderm for Dorsal Nasal Augmentation.,"BACKGROUND


Dorsal augmentation of the nose for aesthetic and reconstructive purposes is an important issue in rhinoplasty surgery. This study aimed to compare the two methods of dice cartilage wrapping for dorsal augmentation of the nose including temporalis fascia and alloderm.
METHODS


In a clinical trial study, 50 patients who needed to augment the nasal dorsum, were enrolled and randomly allocated to two equal groups. In the first group, diced cartilage graft of the patient was wrapped in temporalis fascia and in the second group, a thin sheet of alloderm was used for this purpose. After one year follow up, satisfaction of patients and the expert panel were compared in two groups. Also mean increase in dorsal height was measured and compared in two groups.
RESULTS


The mean increase of dorsal nasal height one year after surgery in the alloderm and temporalis fascia was 3.13±0.49 and 3.42±0.33, respectively and in the fascia group was significantly higher ( p =0.02). The mean of patients' satisfaction in the two groups of alloderm and temporal fascia groups was 7.48±0.92 and 8.04±0.89, respectively ( p =0.03). The mean satisfaction of expert panel in the two methods was 7.56±0.81 and 7.7±0.63, respectively ( p =0.5).
CONCLUSION


The use of temporal fascia for covering the diced cartilage in augmentation of nasal dorsum had better results than the alloderm. Patients satisfaction and mean dorsal height was higher in temporal fascia group.",2020,"The mean increase of dorsal nasal height one year after surgery in the alloderm and temporalis fascia was 3.13±0.49 and 3.42±0.33, respectively and in the fascia group was significantly higher ( p =0.02).",['50 patients who needed to augment the nasal dorsum'],[],"['Patients satisfaction and mean dorsal height', 'dorsal nasal height', 'dorsal height', ""mean of patients' satisfaction"", 'mean satisfaction of expert panel', 'diced cartilage graft']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0225408', 'cui_str': 'Structure of dorsum of nose'}]",[],"[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}]",50.0,0.0276839,"The mean increase of dorsal nasal height one year after surgery in the alloderm and temporalis fascia was 3.13±0.49 and 3.42±0.33, respectively and in the fascia group was significantly higher ( p =0.02).","[{'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Heidari', 'Affiliation': 'Department of General Surgery, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Rasti', 'Affiliation': 'Department of Surgery, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Nadri', 'Affiliation': 'Department of Surgery, School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Roozbehani', 'Affiliation': 'Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Farhang Fallah', 'Affiliation': 'Department of Surgery, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Mahmoudvand', 'Affiliation': 'Department of Surgery, School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}]",World journal of plastic surgery,['10.29252/wjps.9.2.160']
2719,32925788,Biomarkers of postmenopausal osteoporosis and interventive mechanism of catgut embedding in acupoints.,"INTRODUCTION


Postmenopausal osteoporosis (PMOP), which is a common and frequently occurring age-related metabolic bone disease in perimenopausal women, severely affects patients living quality. Modern medicine therapies for PMOP have several problems such as side reactions, low compliance, and high costs. Thus, nonpharmacological modality is urgently needed. Although acupoint thread embedding treatment is widely used in clinical practice, there is no persuasive evidence of its effect on increasing bone mass for PMOP. This experiment aims to investigate the efficacy and safety of acupoint thread embedding on PMOP and elucidate the correlations among brain neural activation, bone mineral density (BMD), and clinical outcomes with magnetic resonance evidence, thus to explore its neural mechanism.
METHODS


This parallel designed, exploratory randomized, controlled, assessor-statistician-blinded, positive medicine clinical trial will include 70 participants with PMOP recruited from 2 traditional Chinese Medicine hospitals. These participants will be randomly allocated to a treatment group (Group Embedding) and a control group (Group Medication) in a 1:1 ratio. Participants in the treatment group will receive acupoint thread embedding treatment once 2 weeks in the following predefined acupoints: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Dazhu (BL11), Xuanzhong (GB39), Zusanli (ST36), and Pishu (BL20). Meanwhile, the participants in the control group will take 0.3 mg Climen tablet orally, 1 tablet/day; every month has a schedule of the 21-day-continuous-taking-medicine period, and 7-day tablet-free period. There is a study period of 3 months and a follow-up period of 1 month for each group. The primary outcomes will be the following therapeutic indexed: Short-Form of McGill Pain Questionnaire (SF-MPQ), Osteoporosis Symptom Score during the observation period and follow-up period. The secondary outcomes will be Osteoporosis Quality of Life Scale (OQOLS), 16-item Assessment of Health-Related Quality of Life in Osteoporosis. In addition, functional magnetic resonance imaging (fMRI) scans and bone density test will be done before and after the observation period to show cranial neuroimaging changes. All the outcomes will be evaluated before and after treatment. The safety of interventions will be assessed at every visit.
DISCUSSION


We present study design and rationale to explore the effectiveness and neural mechanism of acupoint thread embedding for PMOP through these outcomes.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR-INR-17011491.",2020,"This experiment aims to investigate the efficacy and safety of acupoint thread embedding on PMOP and elucidate the correlations among brain neural activation, bone mineral density (BMD), and clinical outcomes with magnetic resonance evidence, thus to explore its neural mechanism.
",['70 participants with PMOP recruited from 2 traditional Chinese Medicine hospitals'],"['acupoint thread embedding treatment once 2 weeks in the following predefined acupoints: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Dazhu (BL11), Xuanzhong (GB39), Zusanli (ST36), and Pishu (BL20', 'control group (Group Medication', 'functional magnetic resonance imaging (fMRI) scans and bone density test']","['Osteoporosis Quality of Life Scale (OQOLS), 16-item Assessment of Health-Related Quality of Life in Osteoporosis', 'McGill Pain Questionnaire (SF-MPQ), Osteoporosis Symptom Score']","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0450614', 'cui_str': 'BL20'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.109307,"This experiment aims to investigate the efficacy and safety of acupoint thread embedding on PMOP and elucidate the correlations among brain neural activation, bone mineral density (BMD), and clinical outcomes with magnetic resonance evidence, thus to explore its neural mechanism.
","[{'ForeName': 'Guizhen', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""The Bao'an District TCM Hospital, The Affiliated Hospital of Guangzhou University of Chinese Medicine, Shenzhen, China.""}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion & Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Bao'an District TCM Hospital, The Affiliated Hospital of Guangzhou University of Chinese Medicine, Shenzhen, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion & Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Junquan', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion & Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Yunxiang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion & Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Medicine,['10.1097/MD.0000000000022178']
2720,32925811,Randomized clinical trial A novel absorbable stapler provides patient-reported outcomes and cost-effectiveness non-inferior to subcuticular skin closure: a prospective single-blinded randomized clinical trial.,"BACKGROUND


Deep dermal suturing is critical for scar quality outcomes. We evaluated a new fast medical device for dermal suturing, with hypothesis of non-inferiority with regard to clinical scar and cost-effectiveness.
METHODS


prospective, patient-blind, randomized, multicentre noninferiority study in 26 french hospitals. Patients were randomized 1:1 to suturing with conventional thread or a semi-automatic stapler. The Patient Scar Assessment Scale (PSAS) was rated at 3 months for primary endpoint effectiveness. Secondary endpoints were cost-effectiveness of the two suturing methods, prevalence of complications, suturing/operating time, Observer Scar Assessment Scale (OSAS) and PSAS, scar's aesthetic quality 18 months after surgery, and occupational exposure to blood (OEB) during surgery.
RESULTS


664 patients were enrolled, 660 randomized, 649 constituted the full analysis (n=324 and 325 in the stapler/needle arms). Primary endopoint PSAS score at 3 months in the stapler arm was not inferior to that in the needle arm, neither after 18 months. The mean operating time was 180 minutes in the stapler arm and 179 in the needle arm (p=ns). The mean suturing time was significantly lower in the stapler arm (p<0.001). There were seven occupational OEB in the needle arm and one in the stapler arm. The two arms did not differ significantly in terms of complications (p=0.41). The additional cost of using the device was 51.57 euros for the complete-case population.
CONCLUSION


Wound healing outcome was no worse than with conventional suturing using a semi-automatic stapler and associated with less OEB.",2020,The mean operating time was 180 minutes in the stapler arm and 179 in the needle arm (p=ns).,"['26 french hospitals', '664 patients were enrolled, 660 randomized, 649 constituted the full analysis (n=324 and 325 in the stapler/needle arms']","['subcuticular skin closure', 'suturing with conventional thread or a semi-automatic stapler', 'conventional suturing using a semi-automatic stapler', 'absorbable stapler']","['mean operating time', 'Wound healing outcome', 'Patient Scar Assessment Scale (PSAS', 'complications', 'OEB', 'occupational OEB', ""cost-effectiveness of the two suturing methods, prevalence of complications, suturing/operating time, Observer Scar Assessment Scale (OSAS) and PSAS, scar's aesthetic quality 18 months after surgery, and occupational exposure to blood (OEB"", 'mean suturing time']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",664.0,0.131367,The mean operating time was 180 minutes in the stapler arm and 179 in the needle arm (p=ns).,"[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Malard', 'Affiliation': 'Department of ENT Surgery, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Duteille', 'Affiliation': 'Department of Burn Plastic Surgery, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Darnis', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Espitalier', 'Affiliation': 'Department of ENT Surgery, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Perrot', 'Affiliation': 'Department of Plastic Surgery, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Ferron', 'Affiliation': 'Department of ENT Surgery, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Planche', 'Affiliation': 'Methodology and Biostatistics Unit, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Jean-Benoit', 'Initials': 'JB', 'LastName': 'Hardouin', 'Affiliation': 'EA 4275 Biostatistics, Pharmacoepidemiology and Human Sciences Research Unit, University of Nantes, Nantes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Tessier', 'Affiliation': 'SPHERE, UMR INSERM U1246, Faculty of Medicine, University of Nantes, Nantes, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Bellanger', 'Affiliation': 'French School of Public Health, Rennes, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dert', 'Affiliation': 'Department of Research and Innovation, University Hospital, Nantes, France.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007356']
2721,32925971,Effectiveness of a mobile health intervention on uptake of recommended postnatal care services in Nigeria.,"Studies have linked the large percentage of maternal and neonatal mortality that occur in postnatal period to low uptake of postnatal care (PNC) services. Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies. However, its use in PNC services' uptake has not been adequately investigated in Nigeria. This study aimed to evaluate the effect of a mobile health intervention on PNC attendance among mothers in selected primary healthcare facilities in Osun State, Nigeria. A quasi-experimental research design was utilised. Participants were allocated to Intervention Group and Control Group. One hundred and ninety pregnant mothers were recruited in each group. A mobile health intervention software was developed and used to send educational and reminder messages to mothers in the intervention group from the 35th week of pregnancy to six weeks after delivery. Uptake of PNC services was assessed at birth, 3 days, 10 days and 42 days after delivery. Data were analysed using descriptive statistics, chi-square and logistic regression models. About one-third (30.9%) of respondents in the intervention group had four postnatal care visits while only 3.7% in the control group had four visits (p < 0.001). After controlling for the effect of confounding variables, group membership remained a significant predictor of PNC uptake. (AOR: 10.869, 95% CI: 4.479-26.374). Mobile health intervention significantly improved utilisation of the recommended four postnatal care visits.",2020,Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies.,"['mothers in selected primary healthcare facilities in Osun State, Nigeria', 'Nigeria', 'One hundred and ninety pregnant mothers']","['Mobile health (mHealth) intervention', 'mobile health intervention', 'Mobile health intervention', 'Intervention Group and Control Group']","['antenatal care utilisation', 'PNC uptake', 'PNC attendance', 'Uptake of PNC services', 'postnatal care visits']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",190.0,0.115177,Mobile health (mHealth) intervention through message reminders has resulted in significant increase in antenatal care utilisation in previous studies.,"[{'ForeName': 'Aanuoluwapo Omobolanle', 'Initials': 'AO', 'LastName': 'Olajubu', 'Affiliation': 'Department of Nursing Science, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'Boluwaji Reuben', 'Initials': 'BR', 'LastName': 'Fajemilehin', 'Affiliation': 'Department of Nursing Science, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.'}, {'ForeName': 'Temitope Oluwafemi', 'Initials': 'TO', 'LastName': 'Olajubu', 'Affiliation': 'Department of Family Medicine, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria.'}, {'ForeName': 'Babajide Samuel', 'Initials': 'BS', 'LastName': 'Afolabi', 'Affiliation': 'Department of Computer Science, Obafemi Awolowo University, Ile-Ife, Nigeria.'}]",PloS one,['10.1371/journal.pone.0238911']
2722,32925992,Evaluation of Recombinant Human Platelet-Derived Growth Factor or Enamel Matrix Derivative Plus Calcium Hydroxide for Pulp Capping: A Randomized Controlled Human Clinical Trial.,"This in vivo study assessed calcium hydroxide's effect as a matrix carrier for recombinant human platelet-derived growth factor (rhPDGF) and enamel matrix protein (EMD) on pulp tissue healing following pulp capping. Intact premolar sites (n = 18) were included. Coronal access and pulpotomy were performed, and each tooth was exposed to the oral cavity for 1 hour before pulp capping was performed. Teeth were randomly assigned to one of the following pulp-capping groups (n = 6 each): Group 1 (CaOH 2  only); Group 2 (CaOH 2 +EMD); and Group 3 (CaOH 2 +rhPDGF). Coronal access cavities were then sealed. Immediate preoperative, postoperative, and 4-month follow-up radiographs were taken. At 4 months, teeth were extracted atraumatically and histomorphometric and micro-CT analyses were performed. Group 1 showed formation of thin, uneven, highly porous dentin-like structure with tunnel defects (average thickness: 0.18 to 0.19 mm). Lack of continuity of the newly formed tissue and interrupted communication tunnels were seen between the pulpal space and pulp-capping material. Group 2 showed formation of highly dense, nonporous, even-thickness dentin-like structure obliterating multiple areas of the pulp space (average thickness: 0.9 to 0.94 mm). Abundant odontoblast lacunae were present in the pulp and structure. Group 3 showed formation of an inconsistent, uneven dentin-like structure that appeared highly porous (average thickness: 1.04 to 1.05 mm). It was without tunneling, and abundant odontoblastic lacunae were present. No statistically significant differences were found between Groups 2 and 3, but both were richer in newly formed dentin-like structure with more thickness than Group 1 ( P  < .05). Addition of EMD to CaOH 2  can result in multiple root canal calcifications, mostly in the coronal and apical thirds of the canals. The calcified tissue does not appear to resemble secondary dentin in form, shape, amount, or density. Addition of rhPDGF to CaOH 2  may not cause root canal calcifications. The newly formed structure differs from secondary dentin in degree of mineralization, porosity, and density.",2020,"No statistically significant differences were found between Groups 2 and 3, but both were richer in newly formed dentin-like structure with more thickness than Group 1 ( P  < .05).","['Intact premolar sites (n = 18) were included', 'Pulp Capping', 'pulp tissue healing following pulp capping']","['rhPDGF', 'Recombinant Human Platelet-Derived Growth Factor or Enamel Matrix Derivative Plus Calcium Hydroxide']",['multiple root canal calcifications'],"[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011402', 'cui_str': 'Capping, Dental Pulp'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",18.0,0.0226737,"No statistically significant differences were found between Groups 2 and 3, but both were richer in newly formed dentin-like structure with more thickness than Group 1 ( P  < .05).","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Al-Hezaimi', 'Affiliation': ''}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Naghshbandi', 'Affiliation': ''}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Alhuzaimi', 'Affiliation': ''}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Alonaizan', 'Affiliation': ''}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'AlQwizany', 'Affiliation': ''}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Rotstein', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4764']
2723,32925999,Outcome of Different Surgical Approaches in the Treatment of Class II Furcation Defects in Mandibular Molars: A Randomized Clinical Trial.,"The aim of this study was to investigate which factors play a major role in the healing of Class II mandibular furcation defects treated with different surgical techniques. Twenty-five systemically healthy subjects with periodontitis stage III grade B and Class II buccal mandibular furcation involvement received one of the following open flap debridement approaches: Group 1 (n = 10), no further treatment; Group 2 (n = 10), piezoelectric contouring of the furcation roof; Group 3 (n = 9), piezoelectric contouring of the furcation roof and bone grafting; Group 4 (n = 10), piezoelectric contouring of the furcation roof and bone grafting with coronally positioned flap. Clinical and radiologic variables-bleeding on probing, probing depth (PPD), vertical and horizontal bone level (CAL and PH), gingival recession, root trunk length, radicular separation, and furcation perimeter (FP)-were evaluated at baseline and 180 days and 1 year after surgery. All clinical parameters were statistically analyzed. Surgical techniques caused clinical (CAL, PPD, PH) and radiographic (FP) improvements. Regenerative techniques and the coronally positioned flap yielded a major radiographic reduction of furcation areas. All therapies resulted in significant horizontal and vertical PPD reduction and CAL gain.",2020,"Surgical techniques caused clinical (CAL, PPD, PH) and radiographic (FP) improvements.","['Twenty-five systemically healthy subjects with periodontitis stage III grade B and Class II buccal mandibular furcation involvement', 'Class II Furcation Defects in Mandibular Molars']","['piezoelectric contouring of the furcation roof and bone grafting with coronally positioned flap', 'piezoelectric contouring of the furcation roof and bone grafting']","['horizontal and vertical PPD reduction and CAL gain', 'clinical (CAL, PPD, PH) and radiographic (FP) improvements', 'Clinical and radiologic variables-bleeding on probing, probing depth (PPD), vertical and horizontal bone level (CAL and PH), gingival recession, root trunk length, radicular separation, and furcation perimeter (FP)-were']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441806', 'cui_str': 'Grade B'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0439790', 'cui_str': 'Horizontal and vertical'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0036679', 'cui_str': 'Separation'}]",25.0,0.0288654,"Surgical techniques caused clinical (CAL, PPD, PH) and radiographic (FP) improvements.","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Bevilacqua', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fonzar', 'Affiliation': ''}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Olivier', 'Affiliation': ''}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'De Biasi', 'Affiliation': ''}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Visintin', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Angerame', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maglione', 'Affiliation': ''}]",The International journal of periodontics & restorative dentistry,['10.11607/prd.4850']
2724,32928140,Recruitment of adolescents with suicidal ideation in the emergency department: lessons from a randomized controlled pilot trial of a youth suicide prevention intervention.,"BACKGROUND


Emergency Departments (EDs) are a first point-of-contact for many youth with mental health and suicidality concerns and can serve as an effective recruitment source for randomized controlled trials (RCTs) of mental health interventions. However, recruitment in acute care settings is impeded by several challenges. This pilot RCT of a youth suicide prevention intervention recruited adolescents aged 12 to 17 years presenting to a pediatric hospital ED with suicide related behaviors.
METHODS


Recruitment barriers were identified during the initial study recruitment period and included: the time of day of ED presentations, challenges inherent to study presentation, engagement and participation during an acute presentation, challenges approaching and enrolling acutely suicidal patients and families, ED environmental factors, and youth and parental concerns regarding the study. We calculated the average recruitment productivity for published trials of adolescent suicide prevention strategies which included the ED as a recruitment site in order to compare our recruitment productivity.
RESULTS


In response to identified barriers, an enhanced ED-centered recruitment strategy was developed to address low recruitment rate, specifically (i) engaging a wider network of ED and outpatient psychiatry staff (ii) dissemination of study pamphlets across multiple areas of the ED and relevant outpatient clinics. Following implementation of the enhanced recruitment strategy, the pre-post recruitment productivity, a ratio of patients screened to patients randomized, was computed. A total of 120 patients were approached for participation, 89 (74.2%) were screened and 45 (37.5%) were consented for the study from March 2018 to April 2019. The screening to randomization ratio for the study period prior to the introduction of the enhanced recruitment strategies was 3:1, which decreased to 1.8:1 following the implementation of enhanced recruitment strategies. The ratio for the total recruitment period was 2.1:1. This was lower than the average ratio of 3.2:1 for published trials.
CONCLUSIONS


EDs are feasible sites for participant recruitment in RCTs examining new interventions for acute mental health problems, including suicidality. Engaging multi-disciplinary ED staff to support recruitment for such studies, proactively addressing anticipated concerns, and creating a robust recruitment pathway that includes approach at outpatient appointments can optimize recruitment.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT03488602 , retrospectively registered April 4, 2018.",2020,"A total of 120 patients were approached for participation, 89 (74.2%) were screened and 45 (37.5%) were consented for the study from March 2018 to April 2019.","['A total of 120 patients were approached for participation, 89 (74.2%) were screened and 45 (37.5%) were consented for the study from March 2018 to April 2019', 'youth suicide prevention intervention recruited adolescents aged 12 to 17\u2009years presenting to a pediatric hospital ED with suicide related behaviors', 'Recruitment barriers were identified during the initial study recruitment period and included: the time of day of ED presentations, challenges inherent to study presentation, engagement and participation during an acute presentation, challenges approaching and enrolling acutely suicidal patients and families, ED environmental factors, and youth and parental concerns regarding the study', 'adolescents with suicidal ideation in the emergency department']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439548', 'cui_str': 'Temporal periods of day'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0686732', 'cui_str': 'Environmental risk factor'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",[],[],120.0,0.111476,"A total of 120 patients were approached for participation, 89 (74.2%) were screened and 45 (37.5%) were consented for the study from March 2018 to April 2019.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tracey', 'Affiliation': 'Department of Psychiatry, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'Divisions of Paediatric Emergency Medicine and Clinical Pharmacology and Toxicology, Hospital for Sick Children, 525 University Avenue, Toronto, ON, M5G 2L3, Canada.'}, {'ForeName': 'Reva', 'Initials': 'R', 'LastName': 'Schachter', 'Affiliation': 'Department of Psychiatry, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Cleverley', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing and Department of Psychiatry, University of Toronto, 130-155 College Street, Toronto, ON, M5P 1T8, Canada.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Monga', 'Affiliation': 'Department of Psychiatry, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Barwick', 'Affiliation': 'Department of Psychiatry, University of Toronto, 250 College St, Toronto, ON, M5T 1R8, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szatmari', 'Affiliation': 'Department of Psychiatry, University of Toronto, 250 College St, Toronto, ON, M5T 1R8, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Clinical Trial Unit, Ontario Child Health Support Unit, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Willan', 'Affiliation': 'Clinical Trial Unit, Ontario Child Health Support Unit, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Centre for Addiction and Mental Health, 5226-88 Workman Way, Toronto, ON, M5J 1H4, Canada.'}, {'ForeName': 'Daphne J', 'Initials': 'DJ', 'LastName': 'Korczak', 'Affiliation': 'Department of Psychiatry, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada. daphne.korczak@sickkids.ca.'}]",BMC medical research methodology,['10.1186/s12874-020-01117-5']
2725,32928161,"Effect of football activity and physical fitness on information processing, inhibitory control and working memory in adolescents.","BACKGROUND


Whilst an acute bout of exercise has been shown to enhance subsequent cognition, including in adolescents, the effects of team games (of which Football is the most popular) has received little attention. Therefore, this study examined: the effect of an acute bout of outdoor Football activity on information processing, inhibitory control, working memory and circulating brain-derived neurotrophic factor (BDNF) in adolescents; the effect of physical fitness on cognition and; the moderating effect of physical fitness on the acute exercise responses.
METHODS


Following familiarisation, 36 adolescents (16 girls) took part in two trials (60-min Football and 60-min seated rest) separated by 7-d in a counterbalanced, crossover design. Information processing and inhibitory control (Stroop Test), and working memory (Sternberg Paradigm) were assessed 30-min before exercise/rest and immediately, 45- and 90-min post-exercise/rest. Capillary blood samples were obtained before exercise/rest and up to 120-min post-exercise/rest. The median split of distance covered on the MSFT was used to divide the group into high- and low-fit groups.
RESULTS


Performance on the cognitive function tasks was similar between Football and seated rest (trial*time interactions; all p > .05). However, the high-fit group had overall quicker response times on both levels of the Stroop Task and all three levels of the Sternberg Paradigm (main effect of fitness; all p < .001). Furthermore, the exercise-cognition relationship was moderated by physical fitness, with improvements in working memory response times seen post-exercise, only in the high-fit group (trial*time*fitness interaction, p < .05). Circulating BDNF was unaffected by the Football activity and physical fitness (p > .05).
CONCLUSION


The present study shows that higher levels of physical fitness are beneficial for cognitive function and provides novel evidence that an ecologically valid, and popular, form of exercise is beneficial for working memory following exercise, in high-fit participants only.",2020,"RESULTS


Performance on the cognitive function tasks was similar between Football and seated rest (trial*time interactions; all p > .05).","['Following familiarisation, 36 adolescents (16 girls) took part in two trials (60-min Football and 60-min seated rest', 'adolescents']","['MSFT', '45- and 90-min post-exercise/rest', 'football activity and physical fitness']","['Circulating BDNF', 'cognitive function tasks', 'median split of distance', 'Football activity and physical fitness', 'Information processing and inhibitory control (Stroop Test), and working memory (Sternberg Paradigm', 'Capillary blood samples']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0419342', 'cui_str': 'Capillary specimen collection'}]",36.0,0.0335067,"RESULTS


Performance on the cognitive function tasks was similar between Football and seated rest (trial*time interactions; all p > .05).","[{'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Williams', 'Affiliation': 'Department of Sport Science; Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Cooper', 'Affiliation': 'Department of Sport Science; Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre, Nottingham Trent University, Nottingham, UK. simon.cooper@ntu.ac.uk.'}, {'ForeName': 'Karah J', 'Initials': 'KJ', 'LastName': 'Dring', 'Affiliation': 'Department of Sport Science; Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Hatch', 'Affiliation': 'Department of Sport Science; Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Morris', 'Affiliation': 'Department of Sport Science; Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sunderland', 'Affiliation': 'Department of Sport Science; Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Nevill', 'Affiliation': 'Department of Sport Science; Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre, Nottingham Trent University, Nottingham, UK.'}]",BMC public health,['10.1186/s12889-020-09484-w']
2726,32928167,Effect of metformin in addition to an antenatal diet and lifestyle intervention on fetal growth and adiposity: the GRoW randomised trial.,"BACKGROUND


The infants born to women who are overweight or obese in pregnancy are at an increased risk of being born macrosomic or large for gestational age. Antenatal dietary and lifestyle interventions have been shown to be ineffective at reducing this risk. Our aim was to examine the effects of metformin in addition to a diet and lifestyle intervention on fetal growth and adiposity among women with a BMI above the healthy range.
METHODS


Women who had a body mass index ≥25 kg/m 2  in early pregnancy, and a singleton gestation, were enrolled in the GRoW trial from three public maternity hospitals in metropolitan Adelaide. Women were invited to have a research ultrasounds at 28 and 36 weeks' gestation at which ultrasound measures of fetal biometry and adiposity were obtained. Fetal biometry z-scores and trajectories were calculated. Measurements and calculations were compared between treatment groups. This secondary analysis was pre-specified.
RESULTS


Ultrasound data from 511 women were included in this analysis. The difference in femur length at 36 weeks' gestation was (0.07 cm, 95% CI 0.01-0.14 cm, p = 0.019) and this was was statistically significant, however the magnitude of effect was small. Differences between treatment groups for all other fetal biometry measures, z-scores, estimated fetal weight, and adiposity measures at 28 and 36 weeks' gestation were similar.
CONCLUSIONS


The addition of metformin to dietary and lifestyle advice in pregnancy for overweight and obese women has no clinically relevant effect on ultrasound measures of fetal biometry or adiposity.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry ( ACTRN12612001277831 ).",2020,"The addition of metformin to dietary and lifestyle advice in pregnancy for overweight and obese women has no clinically relevant effect on ultrasound measures of fetal biometry or adiposity.
","['women with a BMI above the healthy range', 'kg/m 2  in early pregnancy, and a singleton gestation, were enrolled in the GRoW trial from three public maternity hospitals in metropolitan Adelaide', 'Women who had a body mass index ≥25', '511 women were included in this analysis', 'infants born to women who are overweight or obese in pregnancy', 'pregnancy for overweight and obese women']","['Antenatal dietary and lifestyle interventions', 'diet and lifestyle intervention', 'metformin', 'antenatal diet and lifestyle intervention', 'metformin to dietary and lifestyle advice']","['femur length', 'Fetal biometry z-scores and trajectories', 'fetal biometry measures, z-scores, estimated fetal weight, and adiposity measures', 'fetal growth and adiposity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C1300812', 'cui_str': 'Femur length'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}]",511.0,0.200275,"The addition of metformin to dietary and lifestyle advice in pregnancy for overweight and obese women has no clinically relevant effect on ultrasound measures of fetal biometry or adiposity.
","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Poprzeczny', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia. amanda.poprzeczny@adelaide.edu.au.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Deussen', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': 'The University of Adelaide, The Robinson Research Institute, and Discipline of Obstetrics and Gynaecology, Adelaide, South Australia, Australia.'}]",BMC endocrine disorders,['10.1186/s12902-020-00618-0']
2727,32928177,"Lutetium-177-PSMA-I&T as metastases directed therapy in oligometastatic hormone sensitive prostate cancer, a randomized controlled trial.","BACKGROUND


In recent years, there is increasing evidence showing a beneficial outcome (e.g. progression free survival; PFS) after metastases-directed therapy (MDT) with external beam radiotherapy (EBRT) or targeted surgery for oligometastatic hormone sensitive prostate cancer (oHSPC). However, many patients do not qualify for these treatments due to prior interventions or tumor location. Such oligometastatic patients could benefit from radioligand therapy (RLT) with  177 Lu-PSMA; a novel tumor targeting therapy for end-stage metastatic castration-resistant prostate cancer (mCRPC). Especially because RLT could be more effective in low volume disease, such as the oligometastatic status, due to high uptake of radioligands in smaller lesions. To test the hypothesis that  177 Lu-PSMA is an effective treatment in oHSPC to prolong PFS and postpone the need for androgen deprivation therapy (ADT), we initiated a multicenter randomized clinical trial. This is globally, the first prospective study using  177 Lu-PSMA-I&T in a randomized multicenter setting.
METHODS & DESIGN


This study compares  177 Lu-PSMA-I&T MDT to the current standard of care (SOC); deferred ADT. Fifty-eight patients with oHSPC (≤5 metastases on PSMA PET) and high PSMA uptake (SUVmax > 15, partial volume corrected) on  18 F-PSMA PET after prior surgery and/or EBRT and a PSA doubling time of < 6 months, will be randomized in a 1:1 ratio. The patients randomized to the interventional arm will be eligible for two cycles of 7.4GBq  177 Lu-PSMA-I&T at a 6-week interval. After both cycles, patients are monitored every 3 weeks (including adverse events, QoL- and xerostomia questionnaires and laboratory testing) at the outpatient clinic. Twenty-four weeks after cycle two an end of study evaluation is planned together with another  18 F-PSMA PET and (whole body) MRI. Patients in the SOC arm are eligible to receive  177 Lu-PSMA-I&T after meeting the primary study objective, which is the fraction of patients who show disease progression during the study follow up. A second primary objective is the time to disease progression. Disease progression is defined as a 100% increase in PSA from baseline or clinical progression.
DISCUSSION


This is the first prospective randomized clinical study assessing the therapeutic efficacy and toxicity of  177 Lu-PSMA-I&T for patients with oHSPC.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT04443062 .",2020,"SUVmax > 15, partial volume corrected) on  18 F-PSMA PET after prior surgery and/or EBRT and a PSA doubling time of < 6 months, will be randomized in a 1:1 ratio.","['177 Lu-PSMA-I&T in a randomized multicenter setting', 'Fifty-eight patients with oHSPC (≤5 metastases on PSMA PET) and high PSMA uptake ', 'patients with oHSPC', 'oligometastatic hormone sensitive prostate cancer']","['radioligand therapy (RLT', 'Lutetium-177-PSMA-I&T', 'external beam radiotherapy (EBRT', 'RLT']","['therapeutic efficacy and toxicity', 'Disease progression', 'time to disease progression', 'adverse events, QoL- and xerostomia questionnaires and laboratory testing']","[{'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C4505917', 'cui_str': '68Ga-DOTAGA-(3-iodo-y)fk(Sub-KuE)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C4505917', 'cui_str': '68Ga-DOTAGA-(3-iodo-y)fk(Sub-KuE)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",58.0,0.0803198,"SUVmax > 15, partial volume corrected) on  18 F-PSMA PET after prior surgery and/or EBRT and a PSA doubling time of < 6 months, will be randomized in a 1:1 ratio.","[{'ForeName': 'Bastiaan M', 'Initials': 'BM', 'LastName': 'Privé', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel J R', 'Initials': 'MJR', 'LastName': 'Janssen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'van Oort', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Constantijn H J', 'Initials': 'CHJ', 'LastName': 'Muselaers', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Marianne A', 'Initials': 'MA', 'LastName': 'Jonker', 'Affiliation': 'Department of Health Evidence, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'de Groot', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'J Fred', 'Initials': 'JF', 'LastName': 'Verzijlbergen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Tom W J', 'Initials': 'TWJ', 'LastName': 'Scheenen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Zámecnik', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelle O', 'Initials': 'JO', 'LastName': 'Barentsz', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gotthardt', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Noordzij', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wouter V', 'Initials': 'WV', 'LastName': 'Vogel', 'Affiliation': 'Department of Radiology and Nuclear Medicine, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Andries M', 'Initials': 'AM', 'LastName': 'Bergman', 'Affiliation': 'Department of Medical Oncology, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'van der Poel', 'Affiliation': 'Department of Urology, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'André N', 'Initials': 'AN', 'LastName': 'Vis', 'Affiliation': 'Department of Urology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniela E', 'Initials': 'DE', 'LastName': 'Oprea-Lager', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Winald R', 'Initials': 'WR', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'J Alfred', 'Initials': 'JA', 'LastName': 'Witjes', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nagarajah', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. james.nagarajah@radboudumc.nl.'}]",BMC cancer,['10.1186/s12885-020-07386-z']
2728,32928216,Zinc supplementation affects favorably the frequency of migraine attacks: a double-blind randomized placebo-controlled clinical trial.,"BACKGROUND


Observational studies have shown a link between zinc deficiency and migraine headaches. We aimed to examine the effect of zinc supplementation on the characteristics of migraine attacks in patients with migraine.
METHODS


This randomized clinical trial was conducted on 80 patients with migraine. Patients were randomly assigned to receive either zinc sulfate (220 mg/d zinc sulfate) or placebo (lactose) for 8 weeks. Anthropometric measures, serum zinc concentrations, and characteristics of migraine attacks (headache severity, frequency and duration of migraine attacks, and headache daily results) were assessed at baseline and end of the trial.
RESULTS


Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (- 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (- 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients. However, the observed reduction for headache severity became statistically non-significant when the analysis was adjusted for potential confounders and baseline values of headache severity. Other characteristics of migraine attacks including the duration of attacks and headache daily results were not altered following zinc supplementation either before or after controlling for covariates.
CONCLUSION


Zinc supplementation had a beneficial effect on the frequency of migraine attacks in migraine patients. Additional well-designed clinical trials with a long period of intervention and different dosages of zinc are required.
TRIAL REGISTRATION CODE


IRCT20121216011763N23 at www.irct.ir .",2020,"Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (- 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (- 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients.","['80 patients with migraine', 'patients with migraine', 'migraine patients']","['Zinc supplementation', 'placebo', 'zinc supplementation', 'zinc sulfate (220\u2009mg/d zinc sulfate) or placebo (lactose', 'placebo, zinc supplementation']","['duration of attacks and headache daily results', 'frequency of migraine attacks', 'headache severity', 'Anthropometric measures, serum zinc concentrations, and characteristics of migraine attacks (headache severity, frequency and duration of migraine attacks, and headache daily results', 'migraine attacks frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",80.0,0.450099,"Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (- 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (- 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients.","[{'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, P.O. Box 8174673461, Isfahan, Iran.'}, {'ForeName': 'Seyedeh Shabnam', 'Initials': 'SS', 'LastName': 'Mazloumi-Kiapey', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sadeghi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Neurology Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Mottaghi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, P.O. Box 8174673461, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, P.O. Box 8174673461, Isfahan, Iran. askari@mui.ac.ir.'}]",Nutrition journal,['10.1186/s12937-020-00618-9']
2729,32928230,"Correction to: Effects of Bang® Keto Coffee Energy Drink on Metabolism and Exercise Performance in Resistance-Trained Adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['Resistance-Trained Adults'],"['Placebo', 'Bang® Keto Coffee Energy Drink']",['Metabolism and Exercise Performance'],"[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}]","[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.441714,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Harty', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Stratton', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Escalante', 'Affiliation': 'California State University, San Bernardino, California, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Dellinger', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Abegale D', 'Initials': 'AD', 'LastName': 'Williams', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'White', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Smith', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Baylor A', 'Initials': 'BA', 'LastName': 'Johnson', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Sanders', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA.'}, {'ForeName': 'Grant M', 'Initials': 'GM', 'LastName': 'Tinsley', 'Affiliation': 'Energy Balance & Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, 79424, USA. grant.tinsley@ttu.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00378-1']
2730,32928263,"Pilot trial on the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration: a single-arm, open-label study.","OBJECTIVE


This study aimed to explore the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration (PKAN).
METHODS


A single-arm, open-label study was conducted. All subjects received pantethine during the 24-week period of treatment. The primary endpoints were change of the Unified Parkinson's Disease Rating Scale (UPDRS) I-III and Fahn-Marsden (FM) score from baseline to week 24 after treatment.
RESULTS


Fifteen children with PKAN were enrolled, and all patients completed the study. After 24 weeks of treatment with pantethine at 60 mg/kg per day, there was no difference in either UPDRS I-III (t = 0.516, P = 0.614) or FM score (t = 0.353, P = 0.729) between the baseline and W24. Whereas the rates of increase in UPDRS I-III (Z = 2.614, p = 0.009) and FM scores (Z = 2.643, p = 0.008) were slowed. Four patients (26.7%) were evaluated as ""slightly improved"" by doctors through blinded video assessment. Patients with lower baseline UPDRS I-III or FM scores were more likely to be improved. The quality of life of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the quality of life of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM. Serum level of CoA was comparable between baseline and W24. There was no drug related adverse event during the study.
CONCLUSIONS


Pantethine could not significantly improve motor function in children with PKAN after 24 weeks treatment, but it may delay the progression of motor dysfunction in our study. Pantethine was well-tolerated at 60 mg/kg per day.
TRIAL REGISTRATION


Clinical trial registration number at www.chictr.org.cn :ChiCTR1900021076, Registered 27 January2019, the first participant was enrolled 30 September 2018, and other 14 participants were enrolled after the trial was registered.",2020,"The quality of life of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the quality of life of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM.","['Patients with lower baseline', 'www.chictr.org.cn ', 'children with pantothenate kinase-associated neurodegeneration (PKAN', 'Fifteen children with PKAN', 'Registered 27 January2019, the first participant was enrolled 30 September 2018, and other 14 participants were enrolled after the trial was registered', 'children with pantothenate kinase-associated neurodegeneration']","['I-III and Fahn-Marsden', 'pantethine', 'UPDRS']","['quality of life of family members', 'FM scores', 'UPDRS I-III', 'efficacy and safety', 'FM score', ""change of the Unified Parkinson's Disease Rating Scale (UPDRS"", 'Serum level of CoA', 'motor function', 'PedsQL TM 2.0 FIM scores', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018523', 'cui_str': 'Pigmentary pallidal degeneration'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3496228', 'cui_str': 'Leukodystrophy, Dysmyelinating, And Spastic Paraparesis With Or Without Dystonia'}, {'cui': 'C0070034', 'cui_str': 'pantethine'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C3496228', 'cui_str': 'Leukodystrophy, Dysmyelinating, And Spastic Paraparesis With Or Without Dystonia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009226', 'cui_str': 'Coenzyme A'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",15.0,0.0528324,"The quality of life of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the quality of life of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM.","[{'ForeName': 'Xuting', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatrics, Peking University First Hospital, No.1, Xi'an Men Street, West District, Beijing, 100034, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, Peking University First Hospital, No.1, Xi'an Men Street, West District, Beijing, 100034, China.""}, {'ForeName': 'Yuwu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Pediatrics, Peking University First Hospital, No.1, Xi'an Men Street, West District, Beijing, 100034, China.""}, {'ForeName': 'Bufan', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China.'}, {'ForeName': 'Jingmin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Peking University First Hospital, No.1, Xi'an Men Street, West District, Beijing, 100034, China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Pediatrics, Peking University First Hospital, No.1, Xi'an Men Street, West District, Beijing, 100034, China. dryewu@263.net.""}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01530-5']
2731,32928276,Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial.,"BACKGROUND


Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients' quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer.
METHOD


This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%.
DISCUSSION


This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors.
TRIAL REGISTRATION


ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068.",2020,All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS).,"['Cancer-related insomnia (CRI', 'patients with lung cancer', '252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA']","['acupuncture', 'electro-acupuncture', 'electro-acupuncture (EA']","['sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9', 'Efficacy and safety', 'Pittsburgh Sleep Quality Index (PSQI', 'Treatment Emergent Symptom Scale (TESS']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",252.0,0.100995,All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS).,"[{'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Yue', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Acupuncture and Moxibusion College, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Huangan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200003, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Xufeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200062, China.'}, {'ForeName': 'Linglin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200062, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200062, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Xie-Tu Community Health Service Centre, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Zhangjin', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Shifen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China. xu_teacher2006@126.com.'}]",Trials,['10.1186/s13063-020-04721-4']
2732,32928277,An online-based intervention to promote healthy eating through self-regulation among children: study protocol for a randomized controlled trial.,"BACKGROUND


Despite the enormous investment governments allocate to fight obesity, its worldwide prevalence is still on the rise. Moreover, the majority of the programs implemented are still targeting adults struggling with overweightness and focusing on transmitting knowledge about food. However, research shows that obesity prevention is more efficacious and cheaper, and beliefs about healthy eating have a stronger influence on eating behavior than declarative knowledge about food. In fact, knowledge about healthy eating only influences weight status when combined with self-regulation competences. Thus, the main goal of the current project is to develop and evaluate the efficacy of an online preventive intervention program, the HEP-S. This program is designed to promote and develop a set of transversal skills and strategies, related to self-regulation, on the healthy eating domain among school-aged children.
METHODS


A three-armed randomized controlled trial will be conducted in several schools in Portugal. It will include a standard control group, with no intervention; an online intervention group, with the program for 20 weeks; and an enhanced online intervention group, with the program for 20 weeks embedded with gamification strategies throughout the program. Per research group, 40 groups of about 15 children each will be recruited and measured at five different time points. The three research groups will complete the same assessment protocol at the same timings (baseline, post-intervention, and 3, 6, and 9 months' follow-ups). The assessment protocol will include anthropometric and psychological measures. The primary outcome measures will be the development of self-regulation skills for healthy eating over time, the development of self-efficacy attitudes, knowledge about healthy eating over time, and others. The secondary outcome measures will include the effect of gamification strategies, engagement, and satisfaction with the program, among others. The program will comprise the following: (i) a weekly group synchronous videoconference session with a trained educational psychologist serving as a mediator and (ii) a weekly parental involvement activity. Narratives, or story-tools, embedded with self-regulation strategies are at the core of the intervention.
DISCUSSION


The program may play an important role in preventing risky and unhealthy eating behaviors by focusing on the development of self-regulation skills and strategies among elementary school children.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04099498 . Registered on 23 September 2019.",2020,"The primary outcome measures will be the development of self-regulation skills for healthy eating over time, the development of self-efficacy attitudes, knowledge about healthy eating over time, and others.","['healthy eating through self-regulation among children', 'school-aged children', 'elementary school children']","['synchronous videoconference session with a trained educational psychologist serving as a mediator and (ii) a weekly parental involvement activity', 'online-based intervention']","['development of self-regulation skills for healthy eating over time, the development of self-efficacy attitudes, knowledge about healthy eating over time, and others', 'effect of gamification strategies, engagement, and satisfaction with the program, among others']","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0587721', 'cui_str': 'Educational psychologist'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",15.0,0.0494465,"The primary outcome measures will be the development of self-regulation skills for healthy eating over time, the development of self-efficacy attitudes, knowledge about healthy eating over time, and others.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Magalhães', 'Affiliation': 'Department of Applied Psychology, School of Psychology, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal. pcsmagalhaes@gmail.com.'}, {'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Silva', 'Affiliation': 'Department of Applied Psychology, School of Psychology, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Department of Applied Psychology, School of Psychology, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Applied Psychology, School of Psychology, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Guimarães', 'Affiliation': 'Department of Applied Psychology, School of Psychology, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Armanda', 'Initials': 'A', 'LastName': 'Pereira', 'Affiliation': 'Department of Applied Psychology, School of Psychology, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rosário', 'Affiliation': 'Department of Applied Psychology, School of Psychology, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.'}]",Trials,['10.1186/s13063-020-04685-5']
2733,32928279,A phase II randomized trial of sodium oligomannate in Alzheimer's dementia.,"BACKGROUND


Sodium oligomannate (GV-971), a marine-derived oligosaccharide, is a novel agent that may improve cognition in AD patients.
METHODS


The 24-week multicenter, randomized, double-blind, placebo parallel controlled clinical trial was conducted in AD in China between 24 October 2011 and 10 July 2013. The study included a 4-week screening/washout period, followed by a 24-week treatment period. Patients were randomized in a 1:1:1 ratio to receive GV-971 900 mg, 600 mg, or placebo capsule in treatment period, respectively. The primary outcome was cognitive improvement as assessed by changes in Alzheimer's Disease Assessment Scale-cognitive subscale 12-item (ADAS-cog12) scores from baseline to week 24. The secondary efficacy outcomes included CIBIC-Plus, ADCS-ADL, and NPI at 24 weeks after treatment compared with baseline. A subgroup study was assessment of the change in cerebral glucose metabolism by fluorodeoxyglucose positron emission tomography measurements.
RESULTS


Comparing with the placebo group (n = 83, change - 1.45), the ADAS-cog12 score change in the GV-971 600-mg group (n = 76) was - 1.39 (p = 0.89) and the GV-971 900-mg group (n = 83) was - 2.58 (p = 0.30). The treatment responders according to CIBIC-Plus assessment were significantly higher in the GV-971 900-mg group than the placebo group (92.77% vs. 79.52%, p < 0.05). The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05. The respective rates of treatment-related AEs were 5.9%, 14.3%, and 3.5%.
CONCLUSIONS


GV-971 was safe and well tolerated. GV-971 900 mg was chosen for phase III clinical study.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01453569 . Registered on October 18, 2011.",2020,"The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05.","[""Alzheimer's dementia"", 'AD patients', 'AD in China between 24 October 2011 and 10 July 2013']","['placebo', 'GV-971 900\u2009mg, 600\u2009mg, or placebo', 'sodium oligomannate', 'GV-971']","['respective rates of treatment-related AEs', 'safe and well tolerated', 'CIBIC-Plus, ADCS-ADL, and NPI', 'cerebral metabolic rate for glucose', ""cognitive improvement as assessed by changes in Alzheimer's Disease Assessment Scale-cognitive subscale 12-item"", 'ADAS-cog12 score change', 'cerebral glucose metabolism']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.566234,"The GV-971 900-mg subgroup showed a lower decline of cerebral metabolic rate for glucose than the placebo subgroup at the left precuneus, right posterior cingulate, bilateral hippocampus, and bilateral inferior orbital frontal at uncorrected p = 0.05.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. wtshhwy@163.com.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Kuang', 'Affiliation': 'Department of Psychiatry, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Geriatric Psychiatry, Wuxi Mental Health Center, Wuxi, Jiangsu, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Hospital of 81st Group Army PLA, Zhangjiakou, Hebei, China.'}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Geriatric Psychiatry, Nanjing Brain Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yangmei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Baojun', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Baotou Central Hospital, Baotou, Inner Mongolia Autonomous Region, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Neurology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Honghua', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Central War Zone General Hospital of the Chinese People's Liberation Army, Wuhan, Hubei, China.""}, {'ForeName': 'Chuanzhu', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Yifeng', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Neurology, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Mouni', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Geriatric Psychiatry, Guangzhou Brian Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Neurology, The First Hospital of China Medical University, Shenyang, Liaoning, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""Department of Neurology, Tangdu Hospital, Air Force Military Medical University, Xi'an, Shanxi, China.""}, {'ForeName': 'Shugui', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, The First Hospital Affiliated to AMU (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Neurology, The Second Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Daping Hospital, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurology, Tianjin Medical University general hospital, Tianjin, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Neurology, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'PET Center Huashan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Med-X Research Institution, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, AZ, USA.""}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Xin', 'Affiliation': 'Shanghai Green Valley Pharmaceutical Co Ltd, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zu Chong Zhi Road, Shanghai, 201203, China.'}, {'ForeName': 'Meiyu', 'Initials': 'M', 'LastName': 'Geng', 'Affiliation': 'State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zu Chong Zhi Road, Shanghai, 201203, China. mygeng@simm.ac.cn.'}, {'ForeName': 'Shifu', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Department of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. xiaoshifu@msn.com.'}]",Alzheimer's research & therapy,['10.1186/s13195-020-00678-3']
2734,32928286,A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial.,"BACKGROUND


To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC.
METHODS


This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time.
RESULTS


All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group.
CONCLUSIONS


This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Registry ACTRN12616001578493 . Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15-21, 2017).",2020,PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755).,"['Adult participants (n\u2009=\u2009111', '338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80', 'Prospectively registered on 16 November 2016', 'May 2017 and February 2018', 'patients being discharged to the Hospital in the Home service']","['hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care', 'PICC', 'hydrophobic polyurethane and polyurethane peripherally inserted central catheter', 'hydrophobic polyurethane peripherally inserted central catheter (PICC']","['PICC failure', 'average dwell time', 'central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0032616', 'cui_str': 'Polyisocyanate'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C1736167', 'cui_str': 'Systemic allergic reaction'}]",338.0,0.198843,PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755).,"[{'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'Gavin', 'Affiliation': ""Cancer Care Services, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland, 4029, Australia. Nicole.Gavin@health.qld.gov.au.""}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Kleidon', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, 4111, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, 4111, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': ""Nursing and Midwifery Research Centre, Royal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Ullman', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, 4111, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Northfield', 'Affiliation': ""Cancer Care Services, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland, 4029, Australia.""}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Mihala', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, 4111, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Runnegar', 'Affiliation': 'Infection Management Services, Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marsh', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, 4111, Australia.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Rickard', 'Affiliation': 'Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, 4111, Australia.'}]",Trials,['10.1186/s13063-020-04699-z']
2735,32928289,Newborn's first bath: any preferred timing? A pilot study from Lebanon.,"OBJECTIVE


To try to find the most appropriate time for the newborn's first bath. This prospective randomized study was conducted in one hospital (July-September 2017).
RESULTS


A higher percentage of newborns who had a skin-to-skin contact with their mothers had their bath at 24 h vs 2 h after birth (65.2% vs 33.3%; p = 0.01). A higher percentage of mothers who helped in their baby's bath had their baby's bath at 24 h vs 2 h (65.2% vs 5.9%; p < 0.001) and vs 6 h (65.2% vs 15.7%; p < 0.001) respectively. A higher mean incubation time was seen between newborns who had their bath at 2 h (2.10 vs 1.78; p = 0.002) and 6 h (2.18 vs 1.78; p = 0.003) compared to those who had their bath at 24 h respectively. A higher percentage of newborns who took their first bath 24 h after birth were calm compared to crying vigorously (38.6% vs 9.1%; p = 0.04). Delaying newborn first bath until 24 h of life was associated with benefits (reducing hypothermia and vigorous crying, benefit from the vernix caseosa on the skin and adequate time of skin-to-skin contact and mother participation in her child's bathing.",2020,"Delaying newborn first bath until 24 h of life was associated with benefits (reducing hypothermia and vigorous crying, benefit from the vernix caseosa on the skin and adequate time of skin-to-skin contact and mother participation in her child's bathing.",['one hospital (July-September 2017'],['Lebanon'],['mean incubation time'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0023190', 'cui_str': 'Lebanon'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0277511,"Delaying newborn first bath until 24 h of life was associated with benefits (reducing hypothermia and vigorous crying, benefit from the vernix caseosa on the skin and adequate time of skin-to-skin contact and mother participation in her child's bathing.","[{'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Mardini', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Rahme', 'Affiliation': 'Research Department, Psychiatric Hospital of the Cross, Jal Eddib, Lebanon.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Matar', 'Affiliation': 'Gynecology and Obstetrics Department, Notre Dame Des Secours University Hospital, Byblos, Lebanon.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Abou Khalil', 'Affiliation': 'Gynecology and Obstetrics Department, Notre Dame Des Secours University Hospital, Byblos, Lebanon.'}, {'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Hallit', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon. souheilhallit@hotmail.com.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Fadous Khalife', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik (USEK), Jounieh, Lebanon. mclaude454@hotmail.com.'}]",BMC research notes,['10.1186/s13104-020-05282-0']
2736,32935171,Exploring thoracic kyphosis and incident fracture from vertebral morphology with high-intensity exercise in middle-aged and older men with osteopenia and osteoporosis: a secondary analysis of the LIFTMOR-M trial.,"Our aim was to explore change in kyphosis and vertebral fracture incidence following 8 months of high-intensity resistance and impact training (HiRIT) or machine-based isometric axial compression (IAC) training in men with osteopenia and osteoporosis. HiRIT and IAC improved posture. HiRIT participants did not experience progression or incident vertebral fracture. IAC participants did experience progression and incident vertebral fracture.
INTRODUCTION


The Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men (LIFTMOR-M) trial examined efficacy and safety of an eight-month, supervised, high-intensity progressive resistance and impact training (HiRIT) program compared with machine-based isometric axial compression (IAC) training in middle-aged and older men with low areal bone mineral density (aBMD). The primary purpose of the current work was to explore change in thoracic kyphosis and incident fracture from vertebral morphology following eight-months of HiRIT or IAC training. The secondary purpose was to explore change in clinical kyphosis measures for HiRIT, IAC and a non-randomized, matched control group.
METHODS


Men (≥ 45 yrs), with low aBMD, were recruited and randomized to HiRIT or IAC, or designated control. Clinical measures of thoracic kyphosis with inclinometry were determined. Cobb angle of kyphosis and vertebral fracture assessment using the Genant semi-quantitative method were determined from lateral thoracolumbar DXA (Medix DR, Medilink, France). Per-protocol (n = 40) and intention-to-treat (n = 93) analyses were conducted.
RESULTS


Forty participants (HiRIT n = 20, IAC n = 20; 66.1 ± 7.8 yrs.; lumbar spine T-score - 0.1 ± 0.8; femoral neck T-score - 1.5 ± 0.5) underwent clinical kyphosis measures and thoracolumbar DXA at baseline and follow-up. No between-group differences were detected in kyphosis change, however, within-group improvements in neutral (HiRIT - 2.3 ± 0.8°; IAC - 2.5 ± 0.8°) and 'standing tall' (HiRIT - 2.4 ± 0.8°; IAC - 2.0 ± 0.8°) postures were observed (p < 0.05). HiRIT improved Cobb angle (- 3.5 ± 1.5°, p = 0.027) from baseline. Over the 8 months, no incident vertebral fractures nor progression of prevalent vertebral fractures occurred for HiRIT participants. Five incident fractures of thoracic vertebrae occurred for IAC and one wedge fracture progressed. Ninety-three participants underwent clinical kyphosis measures at both time-points (HiRIT n = 34, IAC n = 33, control n = 26). HiRIT exhibited a reduction in 'standing tall' kyphosis compared to control (- 2.3 ± 0.6° versus 1.4 ± 0.7°, p < 0.05), but no other between-group differences were detected.
CONCLUSIONS


Although there was no difference in change between intervention groups, thoracic kyphosis appeared to improve in both HiRIT and IAC with exercise exposure. HiRIT improved 'standing tall' posture in comparison to usual activities. HiRIT was not associated with vertebral fracture progression or incident vertebral fracture, but for some IAC participants there was evidence of progression of vertebral fracture severity and incident vertebral fractures, in our small sample. Larger trials are required to confirm the observations of the current work, which was exploratory in nature.",2020,"HiRIT improved Cobb angle (- 3.5 ± 1.5°, p = 0.027) from baseline.","['middle-aged and older men with osteopenia and osteoporosis', 'middle-aged and older men with low areal bone mineral density (aBMD', 'Men (≥\u200945\xa0yrs), with low aBMD', 'Forty participants (HiRIT n\u2009=\u200920, IAC n\u2009=\u200920; 66.1\u2009±\u20097.8\xa0yrs.; lumbar spine T-score -\u20090.1\u2009±\u20090.8; femoral neck T-score -\u20091.5\u2009±\u20090.5) underwent clinical kyphosis measures and thoracolumbar DXA at baseline and follow-up', 'men with osteopenia and osteoporosis']","['vertebral morphology with high-intensity exercise', 'HiRIT or IAC, or designated control', 'eight-month, supervised, high-intensity progressive resistance and impact training (HiRIT) program compared with machine-based isometric axial compression (IAC) training', 'HiRIT or IAC training', 'high-intensity resistance and impact training (HiRIT) or machine-based isometric axial compression (IAC) training', 'Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation', 'IAC']","['experience progression or incident vertebral fracture', 'HiRIT and IAC improved posture', 'vertebral fracture progression or incident vertebral fracture', ""HiRIT improved 'standing tall' posture"", 'experience progression and incident vertebral fracture', 'kyphosis change', 'kyphosis and vertebral fracture incidence', 'incident vertebral fractures nor progression of prevalent vertebral fractures', 'HiRIT improved Cobb angle', 'progression of vertebral fracture severity and incident vertebral fractures', ""standing tall' kyphosis""]","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",93.0,0.031551,"HiRIT improved Cobb angle (- 3.5 ± 1.5°, p = 0.027) from baseline.","[{'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Harding', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Weeks', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Watson', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Weis', 'Affiliation': 'The Bone Clinic, Brisbane, Queensland, Australia.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Beck', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia. b.beck@griffith.edu.au.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05583-x']
2737,32935261,Sleep problems in preschool-onset major depressive disorder: the effect of treatment with parent-child interaction therapy-emotion development.,"In school-aged children, adolescents, and adults, more than 72% of individuals diagnosed with major depression report co-occurring sleep problems, but little is known about sleep problems in the context of preschool-onset major depressive disorder (PO-MDD). The current study examined the prevalence of various sleep problems in a sample of young children diagnosed with PO-MDD and explored how the treatment of depression, using a modification of parent-child interaction therapy focused on emotional development (PCIT-ED), affects sleep problems. Participants included 229 preschoolers (ages 3-6 years) who met criteria for PO-MDD and participated a single-blind, randomized control trial comparing PCIT-ED to a waitlist control condition. Children were randomly assigned to either PCIT-ED (n = 114) or the waitlist condition (n = 115). Children were assessed at baseline, immediately after PCIT-ED, and 3 months after treatment completion for parent-reported sleep problems across the domains of insomnia, hypersomnia, daytime fatigue, and a total sleep problem index. In our sample, 45% of children had at least one subthreshold sleep problem, 38.4% had at least one threshold sleep problem, and 72.5% had at least one sleep problem (either threshold or subthreshold). Treatment with PCIT-ED significantly reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems, compared to a waitlist condition, even when controlling for child depression. This reduction was maintained at a 3-month follow-up. Sleep problems are a prevalent co-occurring condition with PO-MDD. Interventions such as PCIT-ED that also effectively reduce sleep problems may be particularly beneficial for recovery from PO-MDD.Clinical trial registration information: a randomized control trial of PCIT-ED for preschool depression; https://clinicaltrials.gov/NCT02076425 .",2020,"Treatment with PCIT-ED significantly reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems, compared to a waitlist condition, even when controlling for child depression.","['young children diagnosed with PO-MDD', 'school-aged children, adolescents, and adults, more than 72% of individuals diagnosed with major depression report co-occurring sleep problems', 'Participants included 229 preschoolers (ages 3-6\xa0years) who met criteria for PO-MDD and participated a single-blind', 'preschool-onset major depressive disorder']","['PCIT-ED', 'parent-child interaction therapy-emotion development']","['sleep problems across the domains of insomnia, hypersomnia, daytime fatigue, and a total sleep problem index', 'Sleep problems', 'reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems', 'subthreshold sleep problem']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",229.0,0.109005,"Treatment with PCIT-ED significantly reduced sleep problems, including insomnia, daytime fatigue, and total sleep problems, compared to a waitlist condition, even when controlling for child depression.","[{'ForeName': 'Caroline P', 'Initials': 'CP', 'LastName': 'Hoyniak', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA. choyniak@wustl.edu.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Barch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01641-1']
2738,32935270,A Multicenter Randomized Prospective Study of Early Cholecystectomy for Pediatric Patients with Biliary Colic.,"BACKGROUND


In patients with biliary colic, high-quality prospective data supporting the precise timing of cholecystectomy are lacking. The purpose of this study was to determine the effectiveness of early laparoscopic cholecystectomy in children with biliary colic.
METHODS


A multicenter, parallel-group, randomized study was conducted in patients with biliary colic at 5 hospitals in China. Pediatric patients with biliary colic were prospectively randomized to either the early cholecystectomy or conservative management strategy. The clinical outcomes within 6 months, including the number of biliary colic-free patients and gallstone-related complications, were compared (register number ChiCTR1900021830).
RESULTS


During the first 2 months of follow-up, 71 patients (59.2%, 71/120) receiving conservative management and 124 patients (97.6%, 124/127) in the early cholecystectomy group (p < 0.001) reported being entirely colic-free. The GIQLI measures were higher in the early cholecystectomy group than in the conservative management group (p = 0.032). Acute readmissions occurred in 7 (5.5%) of 127 patients in the early cholecystectomy group, compared with 23 (19.2%) of 120 patients in the conservative management group (risk ratio [RR] 0.25; 95% CI [0.10-0.60], p = 0.001) in the 6-month period.
CONCLUSIONS


Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.",2020,Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.,"['patients with biliary colic', 'patients with biliary colic at 5 hospitals in China', 'Pediatric patients with biliary colic', 'Pediatric Patients with Biliary Colic', 'children with biliary colic', 'A multicenter']","['laparoscopic cholecystectomy', 'Early Cholecystectomy', 'early cholecystectomy or conservative management strategy']","['number of biliary colic-free patients and gallstone-related complications', 'Acute readmissions', 'GIQLI measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151824', 'cui_str': 'Biliary colic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0151824', 'cui_str': 'Biliary colic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0970884,Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, Children's Hospital, Chongqing Medical University, Chongqing, 400014, People's Republic of China.""}, {'ForeName': 'Huanli', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China. guochunbao@cqmu.edu.cn.""}, {'ForeName': 'Chunbao', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China. guochunbao@cqmu.edu.cn.""}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04700-9']
2739,32935287,Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers.,"INTRODUCTION


Balovaptan, an investigational vasopressin 1a receptor antagonist that has been evaluated for improvement of social communication and interaction, is primarily metabolized by cytochrome P450 3A4 (CYP3A4).
METHODS


Two single-center, non-randomized, two-period, phase 1 studies assessed the effect of the strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan in healthy volunteers. Participants received balovaptan (5 or 10 mg/day) alone for 10 days, or in combination with itraconazole (200 mg/day) for 15 days, or rifampicin (600 mg/day) for 10 days, following balovaptan washout and itraconazole/rifampicin pre-dosing. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for the area under the concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ) of balovaptan dosed with vs. without itraconazole/rifampicin were estimated from a mixed effects model.
RESULTS


Both studies comprised 15-16 healthy male and female volunteers. Itraconazole 200 mg/day elevated steady-state exposure to 5 mg/day balovaptan approximately 4.5-5.5-fold (Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max  and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ 5 days to ~ 13-14 days. Rifampicin 600 mg/day resulted in ~ 90% reductions in both the C max  (Day 10 GMR [90% CI], 0.14 [0.12-0.15]) and AUC (0.07 [0.06-0.07]) of balovaptan 10 mg/day. Time to balovaptan steady state could not be determined with rifampicin. There were no clinically significant safety findings in either study.
CONCLUSIONS


Strong modulators of CYP3A4 activity will significantly alter the PK of balovaptan, with the effect of CYP3A4 induction greater than that of inhibition. Caution should be taken when concomitantly dosing balovaptan with moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors.
TRIAL REGISTRATION NUMBER


NCT03579719; NCT03586726.",2020,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max  and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","['Healthy Volunteers', 'healthy volunteers', '15-16 healthy male and female volunteers']","['Rifampicin', 'Itraconazole 200\xa0mg/day elevated steady-state exposure to 5', 'itraconazole/rifampicin', 'balovaptan washout and itraconazole/rifampicin pre-dosing', 'strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan', 'balovaptan (5 or 10\xa0mg/day) alone for 10\xa0days, or in combination with itraconazole', 'rifampicin', 'Itraconazole and Rifampicin']","['Balovaptan Pharmacokinetics', 'Geometric mean ratios (GMRs', 'time to steady state from\u2009', 'concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C2917463', 'cui_str': 'Itraconazole 200 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.036334,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max  and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","[{'ForeName': 'Michael G M', 'Initials': 'MGM', 'LastName': 'Derks', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK. michael.derks@roche.com.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wandel', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Young', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Stuart K', 'Initials': 'SK', 'LastName': 'Bolt', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Meyenberg', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}]",Advances in therapy,['10.1007/s12325-020-01491-y']
2740,32935529,"Change in Weight, BMI, and Body Composition in a Population-Based Intervention Versus Genetic-Based Intervention: The NOW Trial.","OBJECTIVE


The aim of this study was to compare changes in body fat percentage (BFP), weight, and BMI between a standard intervention and a nutrigenomics intervention.
METHODS


The Nutrigenomics, Overweight/Obesity and Weight Management (NOW) trial is a parallel-group, pragmatic, randomized controlled clinical trial incorporated into the Group Lifestyle Balance TM  (GLB) Program. Statistical analyses included two-way ANOVA and split-plot ANOVA. Inclusion criteria consisted of: BMI ≥ 25.0 kg/m 2  , ≥18 years of age, English speaking, willing to undergo genetic testing, having internet access, and not seeing another health care provider for weight-loss advice outside of the study. Pregnancy and lactation were exclusion criteria. GLB groups were randomly assigned 1 to 1 (N = 140) so that participants received either the standard 12-month GLB program or a modified 12-month program (GLB plus nutrigenomics), which included the provision of nutrigenomics information and advice for weight management. The primary outcome was percent change in BFP. Secondary outcomes were change in weight and BMI.
RESULTS


The GLB plus nutrigenomics group experienced significantly (P < 0.05) greater reductions in percent and absolute BFP at the 3-month follow-up and percent BFP at the 6-month follow-up compared with the standard GLB group.
CONCLUSIONS


The nutrigenomics intervention used in the NOW trial can optimize change in body composition up to 6 months.",2020,"The GLB plus nutrigenomics group experienced significantly (P < 0.05) greater reductions in percent and absolute BFP at the 3-month follow-up and percent BFP at the 6-month follow-up compared with the standard GLB group.
","['Inclusion criteria consisted of: BMI\u2009≥\u200925.0 kg/m 2  , ≥18 years of age, English speaking, willing to undergo genetic testing, having internet access, and not seeing another health care provider for weight-loss advice outside of the study']","['GLB', 'standard 12-month GLB program or a modified 12-month program (GLB plus nutrigenomics), which included the provision of nutrigenomics information and advice for weight management']","['Change in Weight, BMI, and Body Composition', 'percent change in BFP', 'body fat percentage (BFP), weight, and BMI', 'absolute BFP', 'change in weight and BMI']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}, {'cui': 'C0332252', 'cui_str': 'Not seen'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1956006', 'cui_str': 'Nutritional Genomics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",140.0,0.0774814,"The GLB plus nutrigenomics group experienced significantly (P < 0.05) greater reductions in percent and absolute BFP at the 3-month follow-up and percent BFP at the 6-month follow-up compared with the standard GLB group.
","[{'ForeName': 'Justine R', 'Initials': 'JR', 'LastName': 'Horne', 'Affiliation': 'Graduate Program in Health and Rehabilitation Sciences, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Gilliland', 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Colleen P', 'Initials': 'CP', 'LastName': ""O'Connor"", 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Seabrook', 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Madill', 'Affiliation': 'Human Environments Analysis Laboratory, The University of Western Ontario, London, Ontario, Canada.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22880']
2741,32935534,"Ripple Effects of a Community-Based Randomized Trial for Rural Women: Strong Hearts, Healthy Communities.",,2020,,"['Rural Women: Strong Hearts, Healthy Communities']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],[],,0.0437807,,"[{'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Lo', 'Affiliation': ''}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': ''}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Eldridge', 'Affiliation': ''}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Donoso', 'Affiliation': ''}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Folta', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strogatz', 'Affiliation': ''}, {'ForeName': 'Miriam E', 'Initials': 'ME', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Lynn C', 'Initials': 'LC', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': ''}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Seguin-Fowler', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22959']
2742,32935549,Positive Lifestyle Behavior Changes Among Canadian Men: Findings From the HAT TRICK Program.,"PURPOSE


To estimate program effectiveness regarding physical activity (PA), diet, and social connectedness as part of a feasibility study.
DESIGN


Pre-post quasi-experimental.
SETTING


HAT TRICK was delivered in collaboration with a Canadian semi-professional ice hockey team and offered at the arena where they trained and played games.
PARTICIPANTS


Participants (N = 62) at baseline were overweight (BMI >25kg/m 2 ) and inactive (<150 minutes of MVPA/week) men age 35+ years.
INTERVENTION


Gender-sensitized 12-week intervention for men targeting PA, healthy eating and social connectedness.
METHOD


Baseline, post-intervention (12 weeks) and 9-month follow-up self-report and accelerometer data were collected. Multi-level modeling assessed growth trajectories of outcome measures across time.
RESULTS


Accelerometer measured weekly/min. of moderate PA showed significant linear trends (95%CI: 42.9 - 175.3) from baseline (147.0 ± 104.6), 12-week (237.7 ± 135.5) and 9-month follow-up (204.89 ± 137.7) qualified with a quadratic trend. Self-reported weekly/min of moderate and vigorous PA showed significant linear trends (95%CI: 94.1, 264.1; 95%CI: 35.1, 109.6) from baseline (52.6 ± 83.8, 22.42 ± 44.9), 12 week (160.1 ± 157.4, 66.6 ± 74.4) and 9-month follow-up (118.6 ± 104.6, 52.2 ± 59.2) qualified with quadratic trends. DINE measured fat score rating showed linear trends over time (95%CI -14.24, -6.8), qualified with a quadratic trend. DINE fibre score and social connectedness showed no trends.
CONCLUSION


Findings yield valuable information about the implementation of gender-sensitized lifestyle interventions for men and demonstrate the importance of male-specific strategies for reaching and engaging overweight, physically inactive men.",2020,"DINE fibre score and social connectedness showed no trends.
","['Participants (N = 62) at baseline were overweight (BMI >25kg/m 2 ) and inactive (<150 minutes of MVPA/week) men age 35+ years', 'HAT TRICK was delivered in collaboration with a Canadian semi-professional ice hockey team and offered at the arena where they trained and played games', 'Canadian Men']",['Gender-sensitized 12-week intervention'],['fat score rating'],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062773', 'cui_str': 'Histone acetyltransferase'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020748', 'cui_str': 'Ice hockey'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0190621,"DINE fibre score and social connectedness showed no trends.
","[{'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Caperchione', 'Affiliation': 'Human Performance Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Bottorff', 'Affiliation': 'Institute for Healthy Living and Chronic Disease Prevention, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Stolp', 'Affiliation': 'Human Performance Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sharp', 'Affiliation': 'Human Performance Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Disciplines, Athabasca University, Edmonton, Alberta, Canada.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Oliffe', 'Affiliation': 'School of Nursing, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Institute of Social Marketing, University of Stirling, United Kingdom.'}]",American journal of health promotion : AJHP,['10.1177/0890117120957176']
2743,32935561,Demonstrating the Clinical Impact of Continuous Glucose Monitoring Within an Integrated Healthcare Delivery System.,"BACKGROUND


Approximately 30 million Americans currently suffer from diabetes, and nearly 55 million people will be impacted by 2030. Continuous glucose monitoring (CGM) systems help patients manage their care with real-time data. Although approximately 95% of those with diabetes suffer from type 2, few studies have measured CGM's clinical impact for this segment within an integrated healthcare system.
METHODS


A parallel randomized, multisite prospective trial was conducted using a new CGM device (Dexcom G6) compared to a standard of care finger stick glucometer (FSG) (Contour Next One). All participants received usual care in primary care clinics for six consecutive months while using these devices. Data were collected via electronic medical records, device outputs, exit surveys, and insurance company (SelectHealth) claims in accordance with institutional review board approval.
RESULTS


Ninety-nine patients were randomized for analysis ( n  = 50 CGM and  n  = 49 FSG). CGM patients significantly decreased hemoglobin A1c ( p  = .001), total visits ( p  = .009), emergency department encounters ( p  = .018), and labs ordered ( p  = .001). Among SelectHealth non-Medicare Advantage patients, per member per month savings were $417 for CGM compared to FSG, but $9 more for Medicare Advantage. Seventy percent of CGM users reported that the technology helped them better understand daily activity and diet compared to only 16% for FSG.
DISCUSSION


Participants using CGM devices had meaningful improvements in clinical outcomes, costs, and self-reported measures compared to the FSG group. Although a larger study is necessary to confirm these results, CGM devices appear to improve patient outcomes while making treatment more affordable.",2020,CGM patients significantly decreased hemoglobin A1c ( p  = .001),"['Ninety-nine patients', 'patients manage their care with real-time data', 'Approximately 30 million Americans currently suffer from diabetes, and nearly 55 million people']","['Continuous glucose monitoring (CGM) systems', 'standard of care finger stick glucometer (FSG) (Contour Next One', 'new CGM device (Dexcom G6', 'usual care', 'CGM']","['clinical outcomes, costs, and self-reported measures', 'total visits', 'emergency department encounters', 'hemoglobin A1c']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0457575', 'cui_str': 'Finger stick'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",99.0,0.040369,CGM patients significantly decreased hemoglobin A1c ( p  = .001),"[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Isaacson', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kaufusi', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sorensen', 'Affiliation': 'Nublu, Salt Lake City, UT, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Joy', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ingram', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Nickolas', 'Initials': 'N', 'LastName': 'Mark', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Briesacher', 'Affiliation': 'Intermountain Healthcare, Salt Lake City, UT, USA.'}]",Journal of diabetes science and technology,['10.1177/1932296820955228']
2744,32935564,"Comparison of the effects of four treatment techniques commonly used in ureteral stone treatment on patients' daily physical functioning: An observational, randomized, controlled study.","OBJECTIVE


To investigate the effect of four different techniques used in the treatment of ureteral stones on patients' daily physical functioning and quality of life (QoL).
MATERIALS AND METHODS


Patients who underwent ureterorenoscopy (URS)-with or without double j stenting (DJS)- and Extracorporeal shock wave lithotripsy (ESWL) were divided into four groups: Group I: ESWL (n=29), Group II: URS (n=43), Group III: URS + 4.8 Fr DJS (n=39), Group IV: URS + 6 Fr DJS (n=42), and Group V: Control (n=30). Short Form-36 (SF-36) was administered to each participant both preoperatively and 14 days after operation. Based on the SF-36 results, the changes in patients' physical functioning and QoL were evaluated.
RESULTS


Ureteral stone treatment was performed in 202 patients. Of these, 153 patients who underwent a successful ESWL or URS procedure in the first attempt were included in the study. Success rates in the first session were 53.7% (29/54) and 83.8% (124/148) for ESWL and URS, respectively (p <0.001). All the four groups were similar with regard to age, gender, body mass index (BMI), stone size, preoperative physical functioning and QoL. However, although postoperative physical functioning, role limitations due to physical health, and energy/fatigue scores were similar in Group I, III, and IV, they were significantly higher in Group II. No major complication associated with ESWL or URS occurred in any patient. However, in Group 2, DJS was inserted in three (7.7%) patients in the early postoperative period (within the first 48 h) due to renal colic attacks secondary to ureterovesical junction mucosal edema.
CONCLUSION


Ureterorenoscopy without DJS seems to be the most advantageous technique in the treatment of ureteral stones in terms of daily physical functioning and QoL. However, it should be noted that patients undergoing URS may require postoperative emergency stenting, though rarely.",2020,"However, although postoperative physical functioning, role limitations due to physical health, and energy/fatigue scores were similar in Group I, III, and IV, they were significantly higher in Group II.","['153 patients who underwent a successful ESWL or URS procedure in the first attempt were included in the study', ""patients' daily physical functioning"", '202 patients', 'Patients who underwent']","['URS + 6 Fr DJS', 'ureteral stone treatment', 'URS', 'Ureterorenoscopy without DJS', 'URS + 4.8 Fr DJS', 'ESWL', 'ureterorenoscopy (URS)-with or without double j stenting (DJS)- and Extracorporeal shock wave lithotripsy (ESWL', 'ureteral stones']","['renal colic attacks secondary to ureterovesical junction mucosal edema', 'Success rates', 'ESWL or URS', ""patients' daily physical functioning and quality of life (QoL"", 'body mass index (BMI), stone size, preoperative physical functioning and QoL', 'postoperative physical functioning, role limitations due to physical health, and energy/fatigue scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}]","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",202.0,0.0295533,"However, although postoperative physical functioning, role limitations due to physical health, and energy/fatigue scores were similar in Group I, III, and IV, they were significantly higher in Group II.","[{'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Sonmez', 'Affiliation': 'Erciyes University, 52958, Urology, Kayseri, Kayseri, Turkey; gokhans72@hotmail.com.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Demir', 'Affiliation': 'Kayseri City Education and Research Hospital, 147026, Urology, Kayseri, Turkey; fatihdemir1975@gmail.com.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Keske', 'Affiliation': 'Kayseri City Education and Research Hospital, 147026, Urology, Kayseri, Turkey; muratkeske@yahoo.co.uk.'}, {'ForeName': 'Mert Ali', 'Initials': 'MA', 'LastName': 'Karadag', 'Affiliation': 'Kayseri City Education and Research Hospital, 147026, Urology, Kayseri, Turkey; karadagmert@yahoo.com.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirtaş', 'Affiliation': 'Erciyes University, 52958, Urology, Kayseri, Kayseri, Turkey; mesane@gmail.com.'}]",Journal of endourology,['10.1089/end.2020.0659']
2745,32935565,Assessment of the Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy for the Treatment of Patients with Nondilated Collecting System.,"PURPOSE


To investigate the clinical value of contrast-enhanced ultrasound (CEUS) in percutaneous nephrolithotomy (PCNL) for kidney stone patients without hydronephrosis.
METHODS


Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study. Patients who met the inclusion criteria were randomized into two groups: a CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group. The operation results of the two groups were compared, including the number of attempts for successful puncture, duration to successful puncture, stone clearance rate, blood loss, postoperative complications and hospital stay.
RESULTS


Fifty-six patients with a nondilated collecting system who underwent PCNL for sixty kidneys were included in this study, including four patients who underwent bilateral PCNL due to bilateral renal stones. There were thirty kidneys in each group. All patients successfully underwent PCNL. The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time. There was no statistically significant difference in stone clearance rate between the two groups. Four cases of double channels were established in the conventional US-guided PCNL group, while there was only one case in the CEUS-guided PCNL group. In the CEUS-guided PCNL group, most cases (96.7%, 29/30) had no or only mild complications, which was significantly better than the conventional US-guided PCNL group (76.7%, 23/30). The mean postoperative hemoglobin loss in the CEUS-guided PCNL group was 9.5 (range 1-25) g/L, which was significantly lower than 15.5 (range 5-52) g/L in the conventional US-guided PCNL group.
CONCLUSION


The CEUS technique can improve visibility of the nondilated renal collecting system, facilitate selection of suitable calyx and identify renal calyx fornix. It also benefits needle placement in patients with a nondilated collecting system.",2020,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","['Fifty-six patients with a nondilated collecting system who underwent PCNL for sixty kidneys', 'Patients with nondilated collecting system kidney stones who underwent PCNL between October 2018 and December 2019 at our hospital were enrolled in this study', 'kidney stone patients without hydronephrosis', 'Patients who met the inclusion criteria', 'patients with a nondilated collecting system', 'Patients with Nondilated Collecting System']","['CEUS-guided PCNL group and a conventional ultrasound (US)-guided PCNL group', 'contrast-enhanced ultrasound (CEUS', 'Contrast-Enhanced Ultrasound in Percutaneous Nephrolithotomy', 'PCNL', 'percutaneous nephrolithotomy (PCNL', 'bilateral PCNL']","['mild complications', 'number of attempts for successful puncture, duration to successful puncture, stone clearance rate, blood loss, postoperative complications and hospital stay', 'successful rate of one puncture and shorter puncture time', 'mean postoperative hemoglobin loss', 'bilateral renal stones', 'stone clearance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]",56.0,0.0184341,"The CEUS-guided PCNL group had more accurate punctures, with a higher successful rate of one puncture and shorter puncture time.","[{'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'China Three Gorges University, 26476, department of urology, Xiling one road 21, Yichang, China, 443002; xiongguo1994@163.com.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, yichang, hubei, China; 702032715@qq.com.'}, {'ForeName': 'Zonglai', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, yichang, hubei, China; 85538230@qq.com.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Department of Urology, yichang, hubei, China; 519503214@qq.com.'}, {'ForeName': 'Xiaozhan', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of ultrasound, yichang, hubei, China; 498051783@qq.com.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, yichang, hubei, China; enjoyyh@163.com.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, yichang, hubei, China; conquer666@126.com.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, yichang, hubei, China; 2655673989@qq.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ai', 'Affiliation': 'Department of Urology, yichang, hubei, China; docaiwei@163.com.'}, {'ForeName': 'Ziqiu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of Urology, yichang, hubei, China; 364683561@qq.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Du', 'Affiliation': 'Department of Urology, yichang, hubei, China; 2976539511@qq.com.'}]",Journal of endourology,['10.1089/end.2020.0564']
2746,32935574,Biomechanical Stability of Primary and Revision Sacroiliac Joint Fusion Devices: A Cadaveric Study.,"STUDY DESIGN


An in vitro biomechanics study.
OBJECTIVE


To evaluate the efficacy of triangular titanium implants in providing mechanical stabilization to a sacroiliac joint with primary and revision sized implants.
METHODS


Ten lumbopelvic cadaveric specimens were tested in 4 stages: intact, pubic symphysis sectioned, primary, and simulated revision. Primary treatment was performed using 3 laterally placed triangular titanium implants. To simulate revision conditions before and after bone ingrowth and ongrowth on the implants, 7.5-mm and 10.75-mm implants were randomly assigned to one side of each specimen during the simulated revision stage. A 6 degrees of freedom spinal loading frame was used to load specimens in 4 directions: flexion extension, lateral bending, axial torsion, and axial compression. Biomechanical evaluation was based on measures of sacroiliac joint rotational and translational motion.
RESULTS


Both primary and revision implants showed the ability to reduce translational motion to a level significantly lower than the intact condition when loaded in axial compression. Simulated revision conditions showed no statistically significant differences compared with the primary implant condition, with the exception of flexion-extension range of motion where motions associated with the revised condition were significantly lower. Comparison of rotational and translation motions associated with the 7.5- and 10.75-mm implants showed no significant differences between the treatment conditions.
CONCLUSIONS


These results indicate that implantation of laterally placed triangular titanium implants significantly reduces the motion of a sacroiliac joint using either the primary and revision sized implants. No statistically significant differences were detected when comparing the efficacy of primary, 7.5-mm revision, or 10.75-mm revision implants.",2020,Both primary and revision implants showed the ability to reduce translational motion to a level significantly lower than the intact condition when loaded in axial compression.,"['Ten lumbopelvic cadaveric specimens were tested in 4 stages: intact, pubic symphysis sectioned, primary, and simulated revision']","['Primary and Revision Sacroiliac Joint Fusion Devices', 'triangular titanium implants']","['sacroiliac joint rotational and translational motion', 'motion of a sacroiliac joint', 'translational motion']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0034015', 'cui_str': 'Symphysis pubis structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",10.0,0.0369765,Both primary and revision implants showed the ability to reduce translational motion to a level significantly lower than the intact condition when loaded in axial compression.,"[{'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Carbone', 'Affiliation': '6596Allegheny Health Network, Pittsburgh, PA, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Swink', 'Affiliation': '6596Allegheny Health Network, Pittsburgh, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muzzonigro', 'Affiliation': '6596Allegheny Health Network, Pittsburgh, PA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Diehl', 'Affiliation': '6596Allegheny Health Network, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Oh', 'Affiliation': '6596Allegheny Health Network, Pittsburgh, PA, USA.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Lindsey', 'Affiliation': '480623SI-BONE, Inc. Santa Clara, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Yerby', 'Affiliation': '480623SI-BONE, Inc. Santa Clara, CA, USA.'}, {'ForeName': 'Boyle C', 'Initials': 'BC', 'LastName': 'Cheng', 'Affiliation': '6596Allegheny Health Network, Pittsburgh, PA, USA.'}]",Global spine journal,['10.1177/2192568220948028']
2747,32935580,Effects of Caffeine on Intervertebral Disc Cell Viability in a Whole Organ Culture Model.,"STUDY DESIGN


Controlled laboratory study.
OBJECTIVE


To investigate the impact of exposure to physiologically relevant caffeine concentrations on intervertebral disc (IVD) cell viability and extracellular matrix composition (ECM) in a whole organ culture model as potential contributing mechanisms in development and progression of IVD disorders in humans. Primary outcome measures were IVD viable cell density (VCD) and ECM composition.
METHODS


A total of 190 IVD whole organ explants from tails of 16 skeletally mature rats-consisting of cranial body half, endplate, IVD, endplate, and caudal body half-were harvested. IVD explants were randomly assigned to 1 of 2 groups: uninjured (n = 90) or injured (20G needle disc puncture/aspiration method, n = 100). Explants from each group were randomly assigned to 1 of 3 treatment groups: low caffeine (LCAF: 5 mg/L), moderate caffeine (MCAF: 10 mg/L), and high caffeine (HCAF: 15 mg/L) concentrations.
RESULTS


Cell viability was significantly higher in the low-caffeine group compared with the high-caffeine group at day 7 ( P  = .037) and in the low-caffeine group compared with the medium- and high-caffeine groups at day 21 ( P  ≤ .004). Analysis of ECM showed that all uninjured and control groups had significantly higher ( P  < .05) glycosaminoglycan concentrations compared with all injured groups. Furthermore, we observed a temporal, downward trend in proteoglycan to collagen ratio for the caffeine groups.
CONCLUSIONS


Caffeine intake may be a risk factor for IVD degeneration, especially in conjunction with disc injury. Mechanisms for caffeine associated disc degeneration may involve cell and ECM, and further studies should elucidate mechanistic pathways and potential benefits for caffeine restriction.",2020,Analysis of ECM showed that all uninjured and control groups had significantly higher ( P  < .05) glycosaminoglycan concentrations compared with all injured groups.,"['humans', 'A total of 190 IVD whole organ explants from tails of 16 skeletally mature rats-consisting of cranial body half, endplate, IVD, endplate, and caudal body half-were harvested', 'IVD explants']","['low caffeine (LCAF: 5 mg/L), moderate caffeine (MCAF: 10 mg/L), and high caffeine (HCAF: 15 mg/L) concentrations', 'Caffeine']","['intervertebral disc (IVD) cell viability and extracellular matrix composition (ECM', 'Intervertebral Disc Cell Viability', 'glycosaminoglycan concentrations', 'IVD viable cell density (VCD) and ECM composition', 'Cell viability']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0861097', 'cui_str': 'Caffeine increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}, {'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0017973', 'cui_str': 'Mucopolysaccharide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0162339', 'cui_str': 'Cell Density'}]",190.0,0.0243173,Analysis of ECM showed that all uninjured and control groups had significantly higher ( P  < .05) glycosaminoglycan concentrations compared with all injured groups.,"[{'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Raines', 'Affiliation': '14716University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Stannard', 'Affiliation': '14716University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Olivia E', 'Initials': 'OE', 'LastName': 'Stricklin', 'Affiliation': '14716University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Stoker', 'Affiliation': '14716University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Choma', 'Affiliation': '14716University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Cook', 'Affiliation': '14716University of Missouri, Columbia, MO, USA.'}]",Global spine journal,['10.1177/2192568220948031']
2748,32935662,Providing Unique Support for Health Study Among Young Black and Latinx Men Who Have Sex With Men and Young Black and Latinx Transgender Women Living in 3 Urban Cities in the United States: Protocol for a Coach-Based Mobile-Enhanced Randomized Control Trial.,"BACKGROUND


The US National HIV/AIDS Strategy 2020 calls for increasing access to care, improving outcomes of people living with HIV, and targeting biomedical prevention efforts, including access to pre-exposure prophylaxis (PrEP) in communities where HIV is most heavily concentrated. The cities of Baltimore, Maryland (MD); Washington, DC; and Philadelphia, Pennsylvania (PA) are disproportionately burdened by high rates of new cases of HIV infection, with high prevalence among young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years.
OBJECTIVE


This study aims (1) to identify and recruit YBLMSM and YBLTW who are at risk or living with HIV in Baltimore, MD; Philadelphia, PA; and Washington, DC, using respondent-driven sampling (RDS) with targeted seed selection, and (2) to assess the efficacy of a coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC) to increase successful engagement and retention into HIV, PrEP, and substance use treatment care across the HIV care and prevention continua in 3 Mid-Atlantic cities. This paper describes the protocol and progress as of October 20, 2019.
METHODS


This study uses a multiphase mixed methods design. The first phase is a formative, qualitative research with focus group discussions and key informant interviews. The second phase consists of evaluating the ability of RDS with targeted seed selection. The third phase includes 2 embedded randomized controlled trials (RCTs), where participants complete a baseline sociobehavioral survey, rapid HIV testing, and eligible youth enroll in parallel status-dependent RCTs that randomize the participant to 1 of 2 study arms: MEI with coach or SOC. Participants are asked to complete a web-based survey and provide biologic specimens-HIV-1 RNA (viral load) or HIV-1 antibody test and urine drug screen-at baseline and at 3, 6, and 12 months, and an exit interview at 18 months.
RESULTS


A formative qualitative research was conducted in February 2017 and May 2018, and this led to further refinement of recruitment and study methods. Aim 1 recruitment began in September 2017 with subsequent enrollment into the RCTs. Recruitment is ongoing with 520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020. Of these, 159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3).
CONCLUSIONS


This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03194477; https://clinicaltrials.gov/ct2/show/NCT03194477.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17269.",2020,"This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
","['159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3', 'Young Black and Latinx Men', 'young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years', 'Living in 3 Urban Cities in the United States', 'Who Have Sex With Men and Young Black and Latinx Transgender Women', '520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020', 'September 2017 with subsequent enrollment into the RCTs']","['MEI with coach or SOC', 'coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC']",[],"[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3711547', 'cui_str': 'AURKB protein, human'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.144469,"This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Arrington-Sanders', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hailey-Fair', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wirtz', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Cos', 'Affiliation': 'Public Health Management Corporation Research & Evaluation Group, Philadelphia, PA, United States.'}, {'ForeName': 'Noya', 'Initials': 'N', 'LastName': 'Galai', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Durryle', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Marne', 'Initials': 'M', 'LastName': 'Castillo', 'Affiliation': ""The Adolescent Initiative, Children's Hospital of Philadelphia, Philadelphia, MD, United States.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dowshen', 'Affiliation': ""Craig Dalsimer Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, MD, United States.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Trexler', 'Affiliation': ""Adolescent Clinical Research Burgess Clinic, Children's National Medical Center, Washington, DC, United States.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Adolescent Clinical Research Burgess Clinic, Children's National Medical Center, Washington, DC, United States.""}, {'ForeName': 'Jennafer', 'Initials': 'J', 'LastName': 'Kwait', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Beyrer', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Celentano', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.'}]",JMIR research protocols,['10.2196/17269']
2749,32935747,DIAGNOSTIC ACCURACY OF ONE SAMPLE OR TWO SAMPLES QUANTITATIVE FECAL IMMUNOCHEMICAL TESTS FOR INTESTINAL NEOPLASIA DETECTION.,"BACKGROUND


Rectal bleeding is the most important symptom of intestinal neoplasia; thus, tests of occult blood detection in stools are widely used for pre neoplastic lesions and colorectal cancer (CRC) screening.
OBJECTIVE


Evaluate the accuracy of OC-Sensor quantitative test (Eiken Chemical, Tokyo, Japan) at cut-off 10 µg Hb/g feces (50 ng/mL) in a cohort of subjects that had to undergo diagnostic colonoscopy, and if more than one sample collected in consecutive days would improve the diagnostic accuracy of the test.
METHODS


Patients (mean age 56.3±9.7 years) that underwent colonoscopy prospectively randomly received one (1-sample FIT, FIT 1) or two (2-sample FIT, FIT 2) collection tubes. They collected the stool sample before starting colonoscopy preparation. Samples were analyzed by the OC-Auto Micro 80 (Eiken Chemical, Tokyo, Japan). The performance of FIT 1 and FIT 2 were compared to the colonoscopy findings.
RESULTS


Among 289 patients, CRC was diagnosed in 14 (4.8%), advanced adenoma in 37 (12.8%), early adenoma in 71 (24.6%) and no abnormalities in 141 (48.8%). For FIT 1, the sensitivity for CRC was 83.3% (95%CI 36.5-99.1%), for advanced adenoma was 24% (95%CI 10.1-45.5%), with specificity of 86.9% (95%CI 77.3-92.9%). For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%). The positive likelihood ratios were 1.8 (95%CI 0.7-4.4 for FIT 1) and 7.1 (95%CI 2.4-21.4 for FIT 2) for advanced adenoma, and 6.4 (95%CI 3.3-12.3, for FIT 1) and 10.7 (95%CI 3.8-29.8, for FIT 2) for CRC. The negative likelihood ratio were 0.9 (95%CI 0.7-1, for FIT 1) and 0.5 (95%CI 0.3-0.9, for FIT 2) for advanced adenoma, and 0.2 (0.03-1.1, for FIT 1) and 0.3 (0.08-0.9, for FIT 2) for CRC. The differences between FIT 1 and FIT 2 performances were not significant. However, the comparison of the levels of hemoglobin in feces of patients of FIT 1 and FIT 2 showed that the differences between no polyp group and advanced adenoma and CRC were significant.
CONCLUSION


The accuracy of OCR Sensor with 10 µg Hb/g feces cut-off was comparable to other reports and two-sample collection improved the detection rate of advanced adenoma, a pre neoplastic condition to prevent CRC incidence.",2020,"For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%).",['Patients (mean age 56.3±9.7 years) that underwent'],"['colonoscopy prospectively randomly received one (1-sample FIT, FIT 1) or two (2-sample FIT, FIT 2) collection tubes']","['accuracy of OC-Sensor quantitative test (Eiken Chemical, Tokyo, Japan', 'positive likelihood ratios', 'advanced adenoma', 'early adenoma', 'sensitivity for CRC', 'negative likelihood ratio', 'detection rate of advanced adenoma', 'diagnostic accuracy', 'advanced adenoma and CRC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",289.0,0.103434,"For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%).","[{'ForeName': 'Rejane', 'Initials': 'R', 'LastName': 'Mattar', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Gastroenterologia e Hepatologia Clínica, São Paulo, SP, Brasil.'}, {'ForeName': 'Sergio Barbosa', 'Initials': 'SB', 'LastName': 'Marques', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}, {'ForeName': 'Maurício Kazuyoshi', 'Initials': 'MK', 'LastName': 'Minata', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}, {'ForeName': 'Joyce Matie Kinoshita da', 'Initials': 'JMKD', 'LastName': 'Silva-Etto', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Gastroenterologia e Hepatologia Clínica, São Paulo, SP, Brasil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sakai', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'DE Moura', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}]",Arquivos de gastroenterologia,['10.1590/S0004-2803.202000000-58']
2750,32935798,Adhesion molecules before and after propylthiouracil in patients with subclinical hyperthyroidism.,"OBJECTIVE


This study aimed to investigate the effect of propylthiouracil treatment on adhesion molecules in patients with subclinical hyperthyroidism.
METHODS


In this study, a total of 168 patients diagnosed with subclinical hyperthyroidism were treated with propylthiouracil for one year. The levels of adhesion molecules, consisting of sICAM-1, sVCAM-1, and sE-Selectin, before and after the treatment were measured and compared. These results were compared with the levels of 148 healthy controls who received a placebo.
RESULTS


sICAM-1 levels were significantly higher in subclinical hyperthyroidism patients than in healthy controls (*pa=0.000). sICAM-1 levels were significantly decreased after the treatment (**pb=0.000). Despite this decrease in patients with subclinical hyperthyroidism, it did not decrease to the level of the control group. sVCAM-1 did not change before and after propylthiouracil treatment. The level of sE-selectin was similar to that of the pretreatment control group, but it did not have statistical significance, although it increased after the treatment (**pb=0.004).
CONCLUSION


The sICAM level was significantly higher than the pretreatment values and decreased after the propylthiouracil treatment. However, further studies are needed to reduce the risk of atherosclerosis and cancer in patients with subclinical hyperthyroidism.",2020,"The levels of adhesion molecules, consisting of sICAM-1, sVCAM-1, and sE-Selectin, before and after the treatment were measured and compared.","['168 patients diagnosed with subclinical hyperthyroidism were treated with propylthiouracil for one year', '148 healthy controls who received a', 'patients with subclinical hyperthyroidism']","['placebo', 'propylthiouracil treatment']","['sVCAM-1', 'sICAM-1 levels', 'level of sE-selectin', 'levels of adhesion molecules, consisting of sICAM-1, sVCAM-1, and sE-Selectin', 'sICAM level', 'adhesion molecules']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1998045', 'cui_str': 'Subclinical hyperthyroidism'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0033511', 'cui_str': 'Propylthiouracil'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033511', 'cui_str': 'Propylthiouracil'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",168.0,0.0196631,"The levels of adhesion molecules, consisting of sICAM-1, sVCAM-1, and sE-Selectin, before and after the treatment were measured and compared.","[{'ForeName': 'Ferda', 'Initials': 'F', 'LastName': 'Bilgir', 'Affiliation': '. Katip Celebi University Ataturk Training and Research Hospital, Department of Allergy and Immunology, Izmir, Turkey.'}, {'ForeName': 'Oktay', 'Initials': 'O', 'LastName': 'Bilgir', 'Affiliation': '. Health Sciences University Bozyaka Training and Research Hospital, Department of Internal Medicine, Bozyaka, Izmir, Turkey.'}, {'ForeName': 'Ozden Yildirim', 'Initials': 'OY', 'LastName': 'Akan', 'Affiliation': '. Health Sciences University Bozyaka Training and Research Hospital, Department of Internal Medicine, Bozyaka, Izmir, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Demir', 'Affiliation': '. Health Sciences University Bozyaka Training and Research Hospital, Department of Internal Medicine, Bozyaka, Izmir, Turkey.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.8.1057']
2751,32935866,"The reduction impact of monoglucosyl rutin on abdominal visceral fat: A randomized, placebo-controlled, double-blind, parallel-group.","Water soluble α-glycosylated rutin (4G-α-D-glucopyranosyl rutin, monoglucosyl rutin, MR) was used in this study to evaluate its ability to reduce abdominal visceral fat (AVF). We conducted a study examining 66 healthy Japanese men and women with a body mass index of ≥23 and <30 kg/m 2   for 8 weeks. The subjects were randomly assigned to groups via computer random numbers as follows: MR200 group (MR 200 mg/day), MR400 group (MR 400mg/day), or placebo group. The primary outcome was change in the AVF area after 8 weeks of intervention. The secondary outcomes were effects of MR on total fat and subcutaneous fat of umbilical area, lipid-related markers, and subjective symptoms. The per-protocol set analysis involved 18 subjects in the placebo group (7 males and 11 females), 20 subjects in the MR200 group (8 males and 12 females), and 20 subjects in the MR400 group (8 males and 12 females). AVF area in both the MR200 and MR400 groups was reduced at week 8, with changes from the baseline (week 0) significantly higher than the placebo group. Additionally, the MR400 group reported improved subjective symptoms concerning being ""worried about abdominal fat"" at week 4 compared with the placebo group. These results indicate that the consumption of MR (200 and 400 mg/day) for 8 weeks reduced AVF. PRACTICAL APPLICATION: Monoglucosyl rutin, an enzymatically modified form of rutin, is a highly stable and water-soluble flavonoid widely used in food and beverages to prevent oxidation. The present clinical study demonstrated that it may improve overall health by reducing abdominal visceral fat.",2020,"Additionally, the MR400 group reported improved subjective symptoms concerning being ""worried about abdominal fat"" at week 4 compared with the placebo group.","['18 subjects in the placebo group (7 males and 11 females), 20 subjects in the MR200 group (8 males and 12 females), and 20 subjects in the MR400 group (8 males and 12 females', '66 healthy Japanese men and women with a body mass index of ≥23 and <30\xa0kg/m 2\xa0  for 8 weeks']","['MR200', 'Water soluble α-glycosylated rutin (4G-α-D-glucopyranosyl rutin, monoglucosyl rutin, MR', 'placebo', 'MR400', 'monoglucosyl rutin']","['abdominal visceral fat (AVF', 'total fat and subcutaneous fat of umbilical area, lipid-related markers, and subjective symptoms', 'subjective symptoms', 'AVF area', 'MR400', 'overall health']","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0035976', 'cui_str': 'Rutin'}, {'cui': 'C3884877', 'cui_str': 'monoglucosyl-rutin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",66.0,0.164754,"Additionally, the MR400 group reported improved subjective symptoms concerning being ""worried about abdominal fat"" at week 4 compared with the placebo group.","[{'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Hashizume', 'Affiliation': 'Toyo Sugar Refining Co., Ltd, Yoto Bldg., 18-20, Nihombashi-Koamicho, Chuo-ku, Tokyo, 103-0016, Japan.'}, {'ForeName': 'Mahamadou', 'Initials': 'M', 'LastName': 'Tandia', 'Affiliation': 'Toyo Sugar Refining Co., Ltd, Yoto Bldg., 18-20, Nihombashi-Koamicho, Chuo-ku, Tokyo, 103-0016, Japan.'}]",Journal of food science,['10.1111/1750-3841.15429']
2752,32935904,Nopal fiber (Opuntia ficus-indica) improves symptoms in irritable bowel syndrome in the short term: a randomized controlled trial.,"BACKGROUND


Clinical guidelines provide limited and conflicting recommendations regarding dietary fiber supplementation in irritable bowel syndrome (IBS). Nopal (Opuntia ficus-indica) is a cactus plant fiber containing both insoluble and soluble fibers that may have therapeutic potential in IBS. Our aim was to evaluate the dose-response effect of extracted nopal fiber powder on symptoms in IBS.
METHODS


We performed a 4-arm, double-blind, parallel, randomized controlled trial in 60 patients fulfilling Rome IV criteria for IBS. Patients were randomized and blindly allocated to receive either nopal fiber (10, 20, or 30 g/day) or placebo (30 g/day dextrose) for one week and to keep their usual diet. Symptom severity (Global Symptom Question, IBS-SSS, Gastrointestinal Symptom Rating Scale), stool frequency and consistency (Bristol Stool Form Scale), breath hydrogen response, and stool short-chain fatty acids (SCFA) were measured at baseline and follow-up.
KEY RESULTS


Significantly more patients reported adequate relief of symptoms after 20 g/day (87%, p = 0.008) and 30 g/day (80%, p = 0.025) of nopal fiber compared to placebo (33%). More patients receiving 20 g/day nopal fiber (67%) had a > 50% reduction in IBS-SSS compared to placebo (20%, p = 0.027), whereas the 30 g/day dose induced more loose stools (p = 0.027). Response rates were similar among IBS subtypes. There were no differences in breath hydrogen or stool SCFA between groups.
CONCLUSIONS AND INFERENCES


Nopal fiber supplementation at doses of 20 and 30 g/day was associated with short-term improvement in IBS symptoms, warranting a fully powered clinical trial of longer duration with symptomatic, physiological, and microbiological endpoints.",2020,"Significantly more patients reported adequate relief of symptoms after 20 g/day (87%, p = 0.008) and 30 g/day (80%, p = 0.025) of nopal fiber compared to placebo (33%).","['irritable bowel syndrome (IBS', '60 patients fulfilling Rome IV criteria for IBS']","['dietary fiber supplementation', 'placebo', 'Nopal fiber (Opuntia ficus-indica', 'extracted nopal fiber powder', 'nopal fiber']","['breath hydrogen or stool SCFA', 'loose stools', 'Response rates', 'IBS-SSS', 'adequate relief of symptoms', 'IBS symptoms', 'Symptom severity (Global Symptom Question, IBS-SSS, Gastrointestinal Symptom Rating Scale), stool frequency and consistency (Bristol Stool Form Scale), breath hydrogen response, and stool short-chain fatty acids (SCFA']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0556106', 'cui_str': 'Dietary fiber supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1925607', 'cui_str': 'Opuntia ficus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}]",60.0,0.574755,"Significantly more patients reported adequate relief of symptoms after 20 g/day (87%, p = 0.008) and 30 g/day (80%, p = 0.025) of nopal fiber compared to placebo (33%).","[{'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Remes-Troche', 'Affiliation': 'Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Taboada-Liceaga', 'Affiliation': 'Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Amieva-Balmori', 'Affiliation': 'Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Gildardo', 'Initials': 'G', 'LastName': 'Hernández-Ramírez', 'Affiliation': 'Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, Veracruz, Veracruz, Mexico.'}, {'ForeName': 'José F', 'Initials': 'JF', 'LastName': 'García-Mazcorro', 'Affiliation': 'Instituto de Investigaciones Médico-Biológicas, Universidad Veracruzana, Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13986']
2753,32935921,Cutaneous Adverse Events in a Randomized Controlled Trial of Flash Glucose Monitoring Among Youth with Type 1 Diabetes Mellitus.,"BACKGROUND


Literature regarding flash glucose monitoring (FGM) associated cutaneous adverse events (AE) is limited.
OBJECTIVES


This study among youth participating in a six-month randomized controlled trial (RCT) aimed to compare cutaneous adverse events (AE) between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss.
METHODS


Patients aged 13-20 years with type 1 diabetes were randomized to intervention (FGM and usual care) or control (SMBG and usual care). Participants self-reported cutaneous AEs electronically every 14 days. Reports were analyzed to determine frequency, type and severity of cutaneous AEs, and evaluate premature sensor loss.
RESULTS


Sixty-four participants were recruited; 33 randomized to FGM and 31 to control. In total, 80 cutaneous AEs were reported (40 in each group), however the proportion of participants experiencing cutaneous AEs was greater in the FGM group compared to control (58% and 23% respectively, P = 0.004). FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs). For FGM users, 80.0% of cutaneous AEs were mild, 17.5% moderate and 2.5% severe. Among controls, 82.5% of cutaneous AEs were mild and 17.5% moderate. One participant ceased using FGM due to recurring cutaneous AEs. Additionally, over 6-months, 82% of FGM participants experienced at least one premature sensor loss, largely unrelated to a cutaneous AE.
CONCLUSIONS


Cutaneous FGM-associated AEs are common, and mostly rated as mild. However, the majority of users continued FGM despite cutaneous AEs. Awareness of cutaneous complications and mitigation measures may reduce cutaneous AEs and improve the overall experience of FGM. This article is protected by copyright. All rights reserved.",2020,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","['Patients aged 13-20\u2009years with type 1 diabetes', 'Youth with Type 1 Diabetes Mellitus', 'youth participating in a six-month randomized controlled trial (RCT', 'Sixty-four participants were recruited; 33 randomized to']","['Flash Glucose Monitoring', 'intervention (FGM and usual care) or control (SMBG and usual care', 'FGM']","['proportion of participants experiencing cutaneous AEs', 'skin hardening', 'erythema', 'cutaneous adverse events (AE) between FGM and self-monitored blood glucose (SMBG) use and evaluate premature FGM sensor loss', 'premature sensor loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]",64.0,0.0741514,"FGM participants most frequently reported erythema (50% of AEs), while controls most commonly reported skin hardening (60% of AEs).","[{'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Marsters', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': 'Paediatric Department, Southern District Health Board, Invercargill, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}]",Pediatric diabetes,['10.1111/pedi.13121']
2754,32935954,"Brain activity changes following neuroproprioceptive ""facilitation, inhibition"" physiotherapy in multiple sclerosis: a parallel group randomized comparison of two approaches.","BACKGROUND


Imaging methods bring new possibilities for describing the brain plasticity processes that underly the improvement of clinical function after physiotherapy in people with multiple sclerosis (pwMS). Although these processes have been described mainly in connection with task oriented physiotherapy and aerobic training, they haven't been properly verified in neuroproprioceptive ""facilitation, inhibition"" (facilitation) approaches.
AIM


The study determined whether facilitation physiotherapy could enhance brain plasticity, compared two facilitation methods, and looked for any relation to clinical improvement in pwMS.
DESIGN


The study was designed as parallel group (38 outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
POPULATION


The study had 80 participants (38 pwMS and 42 healthy controls).
METHODS


PwMS were divided into two groups and underwent a two-month physiotherapy program - Vojta reflex locomotion (VRL) or Motor Program Activating Therapy (MPAT), (1 hour, twice a week). Functional Magnetic Resonance Imaging (fMRI) and clinical examination was performed before and after therapy. Healthy controls underwent one fMRI examination.
RESULTS


Physiotherapy in pwMS leads to extension of brain activity in specific brain areas (cerebellum, suplementary motor areas and premotor areas) in connection with the improvement of the clinical status of individual patients after therapy (p=0.05). Greater changes (p=0.001) were registered after MPAT than after VRL. The extension of activation was a shift to the examined activation of healthy controls, whose activation was higher in the cerebellum and secondary visual area (p=0.01).
CONCLUSIONS


Neuroproprioceptive ""facilitation, inhibition"" physiotherapy may enhance brain activity and could involve processes connected with the processing of motion activation.
CLINICAL REHABILITATION IMPACT


The study showed that facilitation approach can modulate brain activity. This could be useful for developing of effective physiotherapeutic treatment in MS.",2020,"RESULTS


Physiotherapy in pwMS leads to extension of brain activity in specific brain areas (cerebellum, suplementary motor areas and premotor areas) in connection with the improvement of the clinical status of individual patients after therapy (p=0.05).","['80 participants (38 pwMS and 42 healthy controls', 'PwMS', 'multiple sclerosis', 'people with multiple sclerosis (pwMS', 'parallel group (38 outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls', 'Healthy controls underwent one fMRI examination']","['Functional Magnetic Resonance Imaging (fMRI', 'facilitation physiotherapy', 'physiotherapy program - Vojta reflex locomotion (VRL) or Motor Program Activating Therapy (MPAT', 'neuroproprioceptive ""facilitation, inhibition"" physiotherapy']","['brain plasticity', 'brain activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C5200806', 'cui_str': 'Brain Plasticity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",80.0,0.0329517,"RESULTS


Physiotherapy in pwMS leads to extension of brain activity in specific brain areas (cerebellum, suplementary motor areas and premotor areas) in connection with the improvement of the clinical status of individual patients after therapy (p=0.05).","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Prochazkova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Tintera', 'Affiliation': 'MR Unit, Department of Diagnostic and Interventional Radiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Sarka', 'Initials': 'S', 'LastName': 'Spanhelova', 'Affiliation': 'Department of Rehabilitation, Faculty Hospital in Motol, Prague, Czech Republic.'}, {'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Prokopiusova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rydlo', 'Affiliation': 'MR Unit, Department of Diagnostic and Interventional Radiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.'}, {'ForeName': 'Marketa', 'Initials': 'M', 'LastName': 'Pavlikova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Antonin', 'Initials': 'A', 'LastName': 'Prochazka', 'Affiliation': 'Institute of Biophysics and Informatics, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Rasova', 'Affiliation': 'Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic - kamila.rasova@gmail.com.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06336-4']
2755,31026125,"Knowledge, attitudes, and practices related to salt consumption in Nepal: Findings from the community-based management of non-communicable diseases project in Nepal (COBIN).","High salt/sodium intake is associated with an increased risk of hypertension, which is a major risk factor for cardiovascular diseases. This paper aims to examine the association between salt consumption and salt-related knowledge, attitudes, and practices (KAP) in Nepal. The cross-sectional data used in this study were collected as part of the community-based management of non-communicable diseases project (COBIN) to understand the amount and KAP related to salt consumption in Nepal. Multivariate hierarchical logistic regression was performed to assess the association of salt-related KAP and determinants of high salt consumption in Nepal. The mean per capita salt intake was 8.0 (±3.7) g/day, with 81.6% of the population reporting higher intake than the WHO recommendation of <5 g/day. People of upper castes [adjusted odds ratio (aOR) = 0.7; 95% confidence interval (CI): 0.5-0.9], people in large families (aOR = 0.6; 95% CI: 0.5-0.7), respondents who were advised to lower salt intake (aOR = 0.6; 95% CI: 0.4-0.9) and who checked salt/sodium labels in food (aOR = 0.6; 95% CI: 0.4-0.9) were less likely to consume higher amounts of salt. Similarly, people who added extra salt to their food at the table (aOR = 1.4; 95 CI: 1.1-1.9) and who reported consuming high amounts of salt (aOR = 1.5; 95% CI: 1.1-2.3) were more likely to have high salt intake. High salt intake was documented in this population. This study suggests the need for culturally tailored community-based behavior modification through health education and dietary counseling to effectively reduce salt consumption and thereby support a reduction in hypertension and cardiovascular diseases in Nepal.",2019,"People of upper castes [adjusted odds ratio (aOR) = 0.7; 95% confidence interval (CI): 0.5-0.9], people in large families (aOR = 0.6; 95% CI: 0.5-0.7), respondents who were advised to lower salt intake (aOR = 0.6; 95% CI: 0.4-0.9) and who checked salt/sodium labels in food (aOR = 0.6; 95% CI: 0.4-0.9) were less likely to consume higher amounts of salt.","['hypertension and cardiovascular diseases in Nepal', 'Nepal']",[],"['risk of hypertension', 'mean per capita salt intake']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.0356399,"People of upper castes [adjusted odds ratio (aOR) = 0.7; 95% confidence interval (CI): 0.5-0.9], people in large families (aOR = 0.6; 95% CI: 0.5-0.7), respondents who were advised to lower salt intake (aOR = 0.6; 95% CI: 0.4-0.9) and who checked salt/sodium labels in food (aOR = 0.6; 95% CI: 0.4-0.9) were less likely to consume higher amounts of salt.","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Ghimire', 'Affiliation': 'Nepal Development Society, Chitwan, Nepal.'}, {'ForeName': 'Tara Ballav', 'Initials': 'TB', 'LastName': 'Adhikari', 'Affiliation': 'Nepal Development Society, Chitwan, Nepal.'}, {'ForeName': 'Anupa', 'Initials': 'A', 'LastName': 'Rijal', 'Affiliation': 'Nepal Development Society, Chitwan, Nepal.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kallestrup', 'Affiliation': 'Center for Global Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Henry', 'Affiliation': 'The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Nepal Development Society, Chitwan, Nepal.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13544']
2756,31107249,History of tuberculosis is associated with lower exhaled nitric oxide levels in HIV-infected children.,"OBJECTIVE


HIV disrupts host defense mechanisms and maintains chronic inflammation in the lung. Nitric oxide is a marker of lung inflammation and can be measured in the exhaled air. We investigated the relationship between exhaled nitric oxide (eNO), HIV status and airway abnormalities in perinatally HIV-infected children aged 6-19 years.
DESIGN


A cross-sectional study.
METHODS


HIV-infected individuals on antiretroviral therapy and HIV-uninfected children with no active tuberculosis (TB) or acute respiratory tract infection were recruited from a public hospital in Harare, Zimbabwe. Clinical history was collected and eNO testing and spirometry was performed. The association between eNO and explanatory variables (HIV, FEV1 z-score, CD4 cell count, viral load, history of TB) was investigated using linear regression analysis adjusted for age, sex and time of eNO testing.
RESULTS


In total, 222 HIV-infected and 97 HIV-uninfected participants were included. Among HIV-infected participants, 57 (25.7%) had a history of past TB; 56 (25.2%) had airway obstruction, but no prior TB. HIV status was associated with lower eNO level [mean ratio 0.79 (95% confidence interval, 95% CI 0.65-0.97), P = 0.03]. Within the HIV-infected group, history of past TB was associated with lower eNO levels after controlling for age, sex and time of eNO testing [0.79 (95% CI 0.67-0.94), P = 0.007].
CONCLUSION


HIV infection and history of TB were associated with lower eNO levels. eNO levels may be a marker of HIV and TB-induced alteration in pulmonary physiology; further studies focused on potential causes for lower eNO levels in HIV and TB are warranted.",2019,"HIV status was associated with lower eNO level [mean ratio 0.79 (95% confidence interval, 95% CI 0.65-0.97), P = 0.03].","['HIV-infected individuals on antiretroviral therapy and HIV-uninfected children with no active tuberculosis (TB) or acute respiratory tract infection were recruited from a public hospital in Harare, Zimbabwe', 'In total, 222 HIV-infected and 97 HIV-uninfected participants were included', 'perinatally HIV-infected children aged 6-19 years', 'HIV-infected children']",[],"['history of past TB', 'exhaled nitric oxide levels', 'exhaled nitric oxide (eNO), HIV status and airway abnormalities', 'HIV infection and history of TB', 'eNO and explanatory variables (HIV, FEV1 z-score, CD4 cell count, viral load, history of TB', 'airway obstruction']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0455460', 'cui_str': 'H/O: tuberculosis'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}]",222.0,0.285573,"HIV status was associated with lower eNO level [mean ratio 0.79 (95% confidence interval, 95% CI 0.65-0.97), P = 0.03].","[{'ForeName': 'Evgeniya', 'Initials': 'E', 'LastName': 'Sovershaeva', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, UiT-The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kranzer', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Mchugh', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave Road, Harare, Zimbabwe.'}, {'ForeName': 'Tsitsi', 'Initials': 'T', 'LastName': 'Bandason', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave Road, Harare, Zimbabwe.'}, {'ForeName': 'Edith D', 'Initials': 'ED', 'LastName': 'Majonga', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Usmani', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rowland-Jones', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Gutteberg', 'Affiliation': 'Department of Microbiology and Infection Control.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Flægstad', 'Affiliation': 'Department of Pediatrics, University Hospital of North Norway.'}, {'ForeName': 'Rashida A', 'Initials': 'RA', 'LastName': 'Ferrand', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK.'}, {'ForeName': 'Jon Ø', 'Initials': 'JØ', 'LastName': 'Odland', 'Affiliation': 'Department of Community Medicine, Faculty of Health Sciences, UiT-The Arctic University of Norway, Tromsø, Norway.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002265']
2757,31125186,Comprehensive examination of the multilevel adverse risk and protective factors for cardiovascular disease among hypertensive African Americans.,"This paper describes the multilevel factors that contribute to hypertension disparities in 2052 hypertensive African Americans (mean age 52.9 ± 9.9 years; 66.3% female) who participated in a clinical trial. At the family level, participants reported average levels of life chaos and high social support. However, at the individual level, participants exhibited several adverse clinical and behavioral factors including poor blood pressure control (45% of population), obesity (61%), medication non-adherence (48%), smoking (32%), physical inactivity (45%), and poor diet (71%). While participants rated their provider as trustworthy, they reported high levels of discrimination in the health care system. Finally, community-level data indicate that participants reside in areas characterized by poor socio-economic and neighborhood conditions (eg, segregation). In the context of our trial, hypertensive African Americans exhibited several adverse risks and protective factors at multiple levels of influence. Future research should evaluate the impact of these factors on cardiovascular outcomes using a longitudinal design.",2019,"While participants rated their provider as trustworthy, they reported high levels of discrimination in the health care system.","['hypertensive African Americans', '2052 hypertensive African Americans (mean age 52.9\xa0±\xa09.9\xa0years; 66.3% female) who participated in a clinical trial']",[],"['several adverse clinical and behavioral factors including poor blood pressure control', 'average levels of life chaos and high social support', 'medication non-adherence', 'physical inactivity']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0746935', 'cui_str': 'Noncompliance with medication regimen'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",2052.0,0.0165281,"While participants rated their provider as trustworthy, they reported high levels of discrimination in the health care system.","[{'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Schoenthaler', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Kezhen', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Ramos', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Lynne D', 'Initials': 'LD', 'LastName': 'Richardson', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ogedegbe', 'Affiliation': 'Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Horowitz', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13560']
2758,32871947,Comparison of high ligation of great saphenous vein using pneumatic tourniquets and conventional method for great saphenous vein varicosis.,"To investigate the efficiency of high ligation, great saphenous vein stripping and subfascial perforator vein surgery for treating great saphenous vein varicosis under the assistance of sterilized electric pneumatic tourniquet and Esmarchs bandage.In total, 274 patients confirmed with primary varicosis between January 2014 and November 2017 were included in this study. Patients were divided intoAfter surgery, the affected limbs in both groups were wrapped up using the elastic bandage for 2 weeks, followed by wearing elastic stocking for 6 months. Then we analyzed the intraoperative bleeding, surgery time, subcutaneous hemorrhage after surgery and postoperative pains.The surgical time in the treatment group was significantly lower than that of control group (58.62 ± 7.47 minutes vs 76.35 ± 9.24 minutes, P < .01). The intraoperative bleeding in the treatment group was significantly lower than that of the control group (17.56 ± 3.52 ml vs 49.87 ± 8.78 ml, P < .01).High ligation, great saphenous vein stripping, and subfascial perforator vein surgery under the assistance of sterilized electric pneumatic tourniquet and Esmarch's bandage was effective for the treatment of varicosis in lower limbs featured by reduced surgery time and less bleeding.",2020,"The surgical time in the treatment group was significantly lower than that of control group (58.62 ± 7.47 minutes vs 76.35 ± 9.24 minutes, P < .01).","['274 patients confirmed with primary varicosis between January 2014 and November 2017 were included in this study', 'great saphenous vein varicosis']","['saphenous vein stripping and subfascial perforator vein surgery', 'sterilized electric pneumatic tourniquet and Esmarchs bandage', 'great saphenous vein using pneumatic tourniquets and conventional method']","['surgical time', 'surgery time and less bleeding', 'intraoperative bleeding, surgery time, subcutaneous hemorrhage after surgery and postoperative pains', 'intraoperative bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}]","[{'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0580529', 'cui_str': 'Subfascial'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0179212', 'cui_str': 'Pressure bandage'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0216694,"The surgical time in the treatment group was significantly lower than that of control group (58.62 ± 7.47 minutes vs 76.35 ± 9.24 minutes, P < .01).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Vascular Surgery, Yuhuangding Hospital, Qingdao University.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Basic Research, Yantai Vocational College, Yantai, China.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Vascular Surgery, Yuhuangding Hospital, Qingdao University.'}]",Medicine,['10.1097/MD.0000000000021975']
2759,32628688,A qualitative exploration of cardiovascular disease patients' views and experiences with an eHealth cardiac rehabilitation intervention: The PATHway Project.,"The aim of this study is to explore participants' views and experiences of an eHealth phase 3 cardiac rehabilitation (CR) intervention: Physical Activity Towards Health (PATHway). Sixty participants took part in the PATHway intervention. Debriefs were conducted after the six-month intervention. All interviews were audio recorded and transcribed verbatim. Transcripts were analysed with Braun and Clarke's thematic analysis. Forty-four (71%) debriefs were conducted (n = 34 male, mean (SD) age 61 (10) years). Five key themes were identified: (1) Feedback on the components of the PATHway system, (2) Motivation, (3) Barriers to using PATHway, (4) Enablers to using PATHway, and (5) Post programme reflection. There were a number of subthemes within each theme, for example motivation explores participants motivation to take part in PATHway and participants motivation to sustain engagement with PATHway throughout the intervention period. Participant engagement with the components of the PATHway system was variable. Future research should focus on optimising participant familiarisation with eHealth systems and employ an iterative approach to development and evaluation.",2020,Future research should focus on optimising participant familiarisation with eHealth systems and employ an iterative approach to development and evaluation.,"['Sixty participants took part in the PATHway intervention', 'Forty-four (71%) debriefs were conducted (n = 34 male, mean (SD) age 61 (10) years', ""participants' views and experiences of an eHealth phase 3""]","['eHealth cardiac rehabilitation intervention', 'cardiac rehabilitation (CR) intervention: Physical Activity Towards Health (PATHway']",[],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],60.0,0.0156584,Future research should focus on optimising participant familiarisation with eHealth systems and employ an iterative approach to development and evaluation.,"[{'ForeName': 'Orlagh', 'Initials': 'O', 'LastName': ""O'Shea"", 'Affiliation': 'School of Physiotherapy, Royal College of Surgeons of Ireland, Dublin, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Woods', 'Affiliation': 'Department of Physical Education and Sport Sciences, Physical Activity for Health, Health Research Institute, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'McDermott', 'Affiliation': 'ExWell Medical, Dublin, Ireland.'}, {'ForeName': 'Roselien', 'Initials': 'R', 'LastName': 'Buys', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Cornelis', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jomme', 'Initials': 'J', 'LastName': 'Claes', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gallagher', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Newton', 'Affiliation': 'Beaumont University Hospital, Dublin, Ireland.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Moyna', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'McCaffrey', 'Affiliation': 'ExWell Medical, Dublin, Ireland.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Susta', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'McDermott', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'McCormack', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Budts', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Moran', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}]",PloS one,['10.1371/journal.pone.0235274']
2760,31587681,Confusion and nutritional backlash from news media exposure to contradictory information about carbohydrates and dietary fats.,"OBJECTIVE


To test the effect of news media exposure to contradictory information about carbohydrates and dietary fats on levels of confusion, nutritional backlash and dietary intentions.
DESIGN


We conducted an online survey experiment between 11 and 28 February 2018, randomizing participants to one of six experimental conditions. Two 'contradictory information' conditions asked participants to read one news article on the risks of a low-carbohydrate diet and one article on the risks of a low-fat diet. Two 'convergent information' conditions asked participants to read two articles with similar information on the risks of one of these two diets. A fifth 'established health recommendations' control condition asked participants to read two articles on the harms of smoking and sun exposure. A sixth 'no information' condition served as a second control group. We used general linear models to test hypotheses on the effects of exposure on confusion, nutritional backlash and dietary intentions.
SETTING


USA.
PARTICIPANTS


Adults (n 901) registered with Amazon's Mechanical Turk (M-Turk).
RESULTS


Exposure to contradictory information about carbohydrates and dietary fats increased confusion and nutritional backlash compared with exposure to established health recommendations for non-dietary behaviours and a no-exposure control. Exposure to contradictory information also increased confusion compared with exposure to consistent nutrition information regarding carbohydrates and dietary fats.
CONCLUSIONS


Contradictory nutrition information in the news media can negatively affect consumers' attitudes, beliefs and behavioural intentions. Dietary debates that play out in the media may adversely influence both short-term dietary decisions and future efforts to communicate about unrelated nutrition issues.",2019,Two 'convergent information' conditions asked participants to read two articles with similar information on the risks of one of these two diets.,"['online survey experiment between 11 and 28 February 2018, randomizing participants to one of six experimental conditions', ""Adults (n 901) registered with Amazon's Mechanical Turk (M-Turk""]",['carbohydrates and dietary fats'],[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}]",[],,0.0125621,Two 'convergent information' conditions asked participants to read two articles with similar information on the risks of one of these two diets.,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Department of Communication, Cornell University, 476 Mann Library Building, Ithaca, NY 14853, USA.'}, {'ForeName': 'Rebekah H', 'Initials': 'RH', 'LastName': 'Nagler', 'Affiliation': 'Hubbard School of Journalism and Mass Communication, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'Department of Communication, Cornell University, 476 Mann Library Building, Ithaca, NY 14853, USA.'}]",Public health nutrition,['10.1017/S1368980019002866']
2761,31648564,Prednisone and Its Active Metabolite Prednisolone Attenuate Lipid Accumulation in Macrophages.,"BACKGROUND


Synthetic forms of glucocorticoids (GCs; eg, prednisone, prednisolone) are anti-inflammatory drugs that are widely used in clinical practice. The role of GCs in cardiovascular diseases, including atherosclerosis, is highly controversial, and their impact on macrophage foam cell formation is still unknown. We investigated the effects of prednisone and prednisolone on macrophage oxidative stress and lipid metabolism.
METHODS AND RESULTS


C57BL/6 mice were intraperitoneally injected with prednisone or prednisolone (5 mg/kg) for 4 weeks, followed by lipid metabolism analyses in the aorta and peritoneal macrophages. We also analyzed the effect of serum samples obtained from 9 healthy human volunteers before and after oral administration of prednisone (20 mg for 5 days) on J774A.1 macrophage atherogenicity. Finally, J774A.1 macrophages, human monocyte-derived macrophages, and fibroblasts were incubated with increasing concentrations (0-200 ng/mL) of prednisone or prednisolone, followed by determination of cellular oxidative status, and triglyceride and cholesterol metabolism. Prednisone and prednisolone treatment resulted in a significant reduction in triglyceride and cholesterol accumulation in macrophages, as observed in vivo, ex vivo, and in vitro. These effects were associated with GCs' inhibitory effect on triglyceride- and cholesterol-biosynthesis rates, through downregulation of diacylglycerol acyltransferase 1 and HMG-CoA reductase expression. Glucocorticoid-induced reduction of cellular lipid accumulation was mediated by the GC receptors on the macrophages, because the GC-receptor antagonist (RU486) abolished these effects. In fibroblasts, unlike macrophages, GCs showed no effects.
CONCLUSION


Prednisone and prednisolone exhibit antiatherogenic activity by protecting macrophages from lipid accumulation and foam cell formation.",2020,"Prednisone and prednisolone treatment resulted in a significant reduction in triglyceride and cholesterol accumulation in macrophages, as observed in vivo, ex vivo, and in vitro.","['9 healthy human volunteers', 'Macrophages']","['prednisone', 'Prednisone and Its Active Metabolite Prednisolone', 'Prednisone and prednisolone', 'prednisone or prednisolone', 'glucocorticoids (GCs; eg, prednisone, prednisolone', 'prednisone and prednisolone']","['vivo, ex vivo, and in vitro', 'cellular lipid accumulation', 'triglyceride- and cholesterol-biosynthesis rates, through downregulation of diacylglycerol acyltransferase 1 and HMG-CoA reductase expression', 'triglyceride and cholesterol accumulation']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0163260', 'cui_str': 'Diacylglycerol acyltransferase'}, {'cui': 'C0020374', 'cui_str': 'Hydroxymethylglutaryl-CoA reductase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.036369,"Prednisone and prednisolone treatment resulted in a significant reduction in triglyceride and cholesterol accumulation in macrophages, as observed in vivo, ex vivo, and in vitro.","[{'ForeName': 'Helana', 'Initials': 'H', 'LastName': 'Jeries', 'Affiliation': 'The Lipid Research Laboratory, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Volkova', 'Affiliation': 'The Lipid Research Laboratory, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grajeda-Iglesias', 'Affiliation': 'The Lipid Research Laboratory, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Najjar', 'Affiliation': 'Department of Internal Medicine E, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Rosenblat', 'Affiliation': 'The Lipid Research Laboratory, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aviram', 'Affiliation': 'The Lipid Research Laboratory, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Hayek', 'Affiliation': 'Department of Internal Medicine E, Rambam Health Care Campus, Haifa, Israel.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248419883591']
2762,31726202,Analysis of Subjective and Objective Screening Techniques as Predictors of Safety for Radial Artery Intervention.,"BACKGROUND


There is no currently accepted standard in safety evaluation for radial artery intervention. We sought to compare the accuracy of various subjective and objective screening techniques in predicting safety for radial artery intervention.
METHODS


Fifty-four patients in a prospective cohort study at a single institution underwent subjective Allen's test, objective Barbeau test, and several objective hand ultrasound techniques to assess safety for radial artery intervention. These results were then compared to the gold standard of conventional hand angiography to document complete palmar arch. Statistical analysis including sensitivity, specificity, positive predictive values, negative predictive values, and accuracy were calculated.
RESULTS


Compared to hand angiography, the subjective Allen's test and the objective Princeps Pollicis Artery ultrasound demonstrated the comparable levels of sensitivity (100% vs. 96.7%, respectively), specificity (100% vs. 100%, respectively), and accuracy (97.2% vs. 97.1%, respectively). The objective Barbeau test demonstrated similar results (sensitivity of 100%, accuracy of 98.2%) with the exception of a lower specificity (50%).
CONCLUSIONS


There is no currently accepted standard in safety evaluation for radial artery intervention. However, preliminary data suggest that certain subjective and objective techniques such as Allen's testing, Princeps Pollicis artery ultrasound, and Barbeau testing are comparable options in predicting palmar arch patency.",2020,"The objective Barbeau test demonstrated similar results (sensitivity of 100%, accuracy of 98.2%) with the exception of a lower specificity (50%).
","[""Fifty-four patients in a prospective cohort study at a single institution underwent subjective Allen's test""]",[],"['levels of sensitivity', 'sensitivity, specificity, positive predictive values, negative predictive values, and accuracy', 'specificity']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231664', 'cui_str': ""Allen's test""}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0511718,"The objective Barbeau test demonstrated similar results (sensitivity of 100%, accuracy of 98.2%) with the exception of a lower specificity (50%).
","[{'ForeName': 'Sharon C', 'Initials': 'SC', 'LastName': 'Kiang', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Linda University School of Medicine, Loma Linda, CA; Division of Vascular Surgery, Department of Surgery, VA Loma Linda Healthcare System, Loma Linda, CA.'}, {'ForeName': 'Arian J', 'Initials': 'AJ', 'LastName': 'Nasiri', 'Affiliation': 'Department of Radiology, Section of Vascular and Interventional Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Strilaeff', 'Affiliation': 'Department of Radiology, Section of Vascular and Interventional Radiology, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Vinoy S', 'Initials': 'VS', 'LastName': 'Prasad', 'Affiliation': 'Division of Cardiology, Department of Medicine, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Aditya S', 'Initials': 'AS', 'LastName': 'Bharadwaj', 'Affiliation': 'Division of Cardiology, Department of Medicine, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Miller', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, VA Loma Linda Healthcare System, Loma Linda, CA.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abou-Zamzam', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Linda University School of Medicine, Loma Linda, CA.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Tomihama', 'Affiliation': 'Department of Radiology, Section of Vascular and Interventional Radiology, Linda University School of Medicine, Loma Linda, CA. Electronic address: rtomihama@llu.edu.'}]",Annals of vascular surgery,['10.1016/j.avsg.2019.11.011']
2763,31731134,"Immediate effects of foot orthoses on lower limb biomechanics, pain, and confidence in individuals with patellofemoral osteoarthritis.","BACKGROUND


Foot orthoses are a recommended treatment for patellofemoral (PF) pain and a number of lower limb osteoarthritic (OA) conditions. However, their mechanism of effect is poorly understood.
RESEARCH QUESTION


To compare the immediate effects of foot orthoses and flat inserts on lower limb biomechanics, knee pain and confidence in individuals with PFOA.
METHODS


Twenty-one participants (14 females; mean ± SD age 58 ± 8 years) with PFOA underwent three-dimensional motion analysis during level-walking, stair ascent, and stair descent under three footwear conditions: (i) their own shoes; (ii) prefabricated foot orthoses; and (iii) flat shoe inserts. Participants reported their average levels of knee pain and confidence after each task. Data were analysed with repeated-measures analysis of variance (ANOVA), effect sizes (partial eta squared), and Bonferroni post-hoc tests.
RESULTS


During level-walking, there was a significant main effect of foot orthoses on peak ankle dorsiflexion angle (F 2  = 0.773, p < 0.001, ƞ 2  = 0.773) and peak ankle external dorsiflexion moment (F 2  = 0.356, p = 0.046, ƞ 2  = 0.356). Foot orthoses decreased the peak ankle dorsiflexion angle compared to the flat insert and shoe conditions, and decreased the peak ankle external dorsiflexion moment relative to flat inserts. During stair descent, there was a significant main effect of foot orthoses on peak ankle external dorsiflexion moment (F 2  = 0.823, p = 0.006, ƞ 2  = 0.738), with a trend towards lower peak dorsiflexion moment for foot orthoses compared to the flat insert and shoe conditions. No significant main effects were observed during stair ascent. No other lower limb biomechanical changes were observed across all three conditions. Knee pain and confidence scores were not significantly different across the three conditions.
SIGNIFICANCE


Prefabricated foot orthoses altered sagittal plane biomechanics of the ankle during level-walking and stair descent in individuals with PFOA. Further research is required to determine whether these changes are clinically beneficial.",2020,"During stair descent, there was a significant main effect of foot orthoses on peak ankle external dorsiflexion moment (F 2  = 0.823, p = 0.006, ƞ 2  = 0.738), with a trend towards lower peak dorsiflexion moment for foot orthoses compared to the flat insert and shoe conditions.","['individuals with patellofemoral osteoarthritis', 'Twenty-one participants (14 females; mean\u2009±\u2009SD age 58\u2009±\u20098 years) with PFOA underwent three-dimensional motion analysis during level-walking, stair ascent, and stair descent under three footwear conditions', 'individuals with PFOA']","['foot orthoses', 'Prefabricated foot orthoses altered sagittal plane biomechanics', 'i) their own shoes; (ii) prefabricated foot orthoses; and (iii) flat shoe inserts']","['lower limb biomechanics, pain, and confidence', 'Knee pain and confidence scores', 'stair ascent', 'peak ankle dorsiflexion angle', 'peak ankle external dorsiflexion moment', 'limb biomechanical changes', 'lower limb biomechanics, knee pain and confidence', 'peak dorsiflexion moment', 'average levels of knee pain and confidence', 'peak ankle external dorsiflexion moment relative', 'variance (ANOVA), effect sizes (partial eta squared), and Bonferroni post-hoc tests']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C1720127', 'cui_str': 'Eta'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",21.0,0.0678867,"During stair descent, there was a significant main effect of foot orthoses on peak ankle external dorsiflexion moment (F 2  = 0.823, p = 0.006, ƞ 2  = 0.738), with a trend towards lower peak dorsiflexion moment for foot orthoses compared to the flat insert and shoe conditions.","[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Tan', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia. Electronic address: jade.tan@latrobe.edu.au.'}, {'ForeName': 'Kane J', 'Initials': 'KJ', 'LastName': 'Middleton', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia; Discipline of Sport and Exercise Science, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia.'}, {'ForeName': 'Harvi F', 'Initials': 'HF', 'LastName': 'Hart', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia; Department of Physical Therapy, Faculty of Health Sciences, Collaborative Training Program in Musculoskeletal Health Research, and Bone and Joint Institute, The University of Western Ontario, London, N6A 3K7, Canada.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, 3086, Australia; School of Health and Rehabilitation Sciences, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, 4072, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2019.10.019']
2764,32926227,"A phase II trial of dose-reduced nab-paclitaxel for patients with previously treated, advanced or recurrent gastric cancer (OGSG 1302).","BACKGROUND


For unresectable or recurrent advanced gastric adenocarcinoma (AGC), tri-weekly administration of nanoparticle albumin-bound paclitaxel (nab-PTX) at 260 mg/m 2  achieved a response rate of 27.8% in a phase II trial in Japan. However, frequent neutropenia and peripheral neuropathy limit its use in clinical settings. We, thus, conducted a single-arm phase II trial to investigate the efficacy and safety of a reduced dose (220 mg/m 2 ) of tri-weekly nab-PTX.
METHODS


Eligible patients included those with AGC and ECOG performance status of 0-2 who had received one or more prior chemotherapy containing fluoropyrimidine regimens. A reduced dose of nab-PTX (220 mg/m 2 ) was administered tri-weekly. The primary endpoint was response rate (RR). Secondary endpoints were overall survival (OS), progression-free survival (PFS), disease-control rate (DCR), incidence of adverse events, relative dose intensity (RDI) and proportion of patients receiving subsequent chemotherapy.
RESULTS


Among 33 patients enrolled, 32 were treated with protocol therapy. RR was 3.1% [95% confidence interval (CI), 0-16.2%], which did not reach the protocol-specified threshold (p = 0.966). DCR was 37.5% (95% CI, 21.1-56.3%). Median OS and PFS were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively. RDI was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy. Toxicity was relatively mild with the most common grade ≥ 3 adverse events being neutropenia (38%), anemia (13%), fatigue (19%), anorexia (16%), and peripheral neuropathy (13%).
CONCLUSION


Tri-weekly nab-PTX with a reduced dose (220 mg/m 2 ) is not recommended for AGC in a second-line or later setting, despite demonstrating less toxicity than at 260 mg/m 2 . Clinical trial registration The OGSG1302 trial was registered with UMIN-CTR as UMIN000000714.",2020,"Median OS and PFS were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively.","['For unresectable or recurrent advanced gastric adenocarcinoma (AGC', 'Eligible patients included those with AGC and ECOG performance status of 0-2 who had received one or more prior chemotherapy containing fluoropyrimidine regimens', '33 patients enrolled, 32 were treated with protocol therapy', 'patients with previously treated, advanced or recurrent gastric cancer (OGSG 1302']","['dose-reduced nab-paclitaxel', 'nab-PTX', 'subsequent chemotherapy', 'nanoparticle albumin-bound paclitaxel (nab-PTX']","['anorexia', 'DCR', 'efficacy and safety', 'overall survival (OS), progression-free survival (PFS), disease-control rate (DCR), incidence of adverse events, relative dose intensity (RDI) and proportion of patients receiving subsequent chemotherapy', 'RR', 'Median OS and PFS', 'Toxicity', 'anemia', 'RDI', 'response rate (RR', 'fatigue', 'toxicity', 'peripheral neuropathy']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]",33.0,0.256661,"Median OS and PFS were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively.","[{'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, 1-3-1, Ryuge, Yao, Osaka, 581-0069, Japan. shigeyuki.tamura@hosp-yao.osaka.jp.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka Saiseikai Senri Hospital, Suita, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Fujita', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Kindai University Hospital, Sayama, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kawada', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, 1-3-1, Ryuge, Yao, Osaka, 581-0069, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Hirao', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Hirota', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Sayama, Osaka, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01768-w']
2765,32926247,The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial.,"INTRODUCTION/OBJECTIVES


The effect of intravenous (IV) golimumab on health-related quality of life (HRQoL) and productivity in patients with ankylosing spondylitis (AS) was evaluated.
METHOD


Patients were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo (n = 103) at weeks 0, 4, 12, with crossover to golimumab 2 mg/kg at weeks 16, 20, then q8w through week 52. Changes from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL) were assessed. Correlations between these outcomes and disease activity and patient functioning outcomes were evaluated post hoc.
RESULTS


At week 16, changes from baseline (mean ± standard deviation) in EQ-5D-5L index (0.17 ± 0.16 vs 0.05 ± 0.14), EQ-VAS (20.3 ± 24.6 vs 4.8 ± 23.5), daily productivity VAS (- 2.9 ± - 2.9 vs - 1.1 ± - 2.5), WLQ productivity loss score (- 3.5 ± - 5.3 vs - 1.9 ± - 4.0), and ASQoL (- 5.4 ± - 5.0 vs - 1.8 ± - 4.5) were greater in the IV golimumab versus placebo group, respectively. At week 28, changes from baseline were similar between the IV golimumab and placebo-crossover groups (EQ-5D-5L index: 0.18 ± 0.17 and 0.16 ± 0.16, EQ-VAS: 20.5 ± 27.9 and 22.5 ± 23.1, daily productivity VAS: - 3.1 ± - 3.0 and - 3.1 ± - 2.8, WLQ productivity loss: - 3.9 ± - 5.5 and - 4.5 ± - 4.5, and ASQoL: - 5.3 ± - 5.2 and - 5.3 ± - 4.8, respectively); improvements were maintained through week 52. HRQoL and productivity outcomes were generally moderately correlated with disease activity and functioning outcomes.
CONCLUSIONS


In patients with AS, IV golimumab produced sustained improvements in HRQoL and productivity through 1 year, which correlated with improvements in disease activity and functioning. ClinicalTrials.gov registry number is NCT02186873. Key Points • Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.",2020,Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.,"['adult patients with active ankylosing spondylitis', 'patients with ankylosing spondylitis (AS', 'Patients']","['intravenous golimumab', 'placebo', 'Intravenous (IV) golimumab', 'intravenous (IV) golimumab']","['HRQoL and productivity', 'health-related quality of life (HRQoL) and productivity', 'disease activity and functioning', 'disease activity and patient functioning outcomes', 'disease activity and functioning outcomes', 'EQ-5D-5L index', 'daily productivity VAS', 'WLQ productivity loss score', 'EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, Work Limitations Questionnaire (WLQ), and Ankylosing Spondylitis Quality of Life (ASQoL', 'health-related quality of life and work productivity', 'HRQoL and productivity outcomes', 'general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.223187,Intravenous (IV) golimumab resulted in clinically important improvement in general and ankylosing spondylitis-specific health-related quality of life (HRQoL) and productivity outcomes in patients with ankylosing spondylitis (AS) as early as week 8 and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in these patients with AS were correlated with improvements in measures of disease activity and patient functional capability • IV golimumab is an effective treatment option for AS that can help mitigate the negative effects of the disease on HRQoL and productivity.,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Reveille', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA. Reveille@uth.tmc.edu.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, The University of Texas McGovern Medical School, 6431 Fannin, MSB 5.270, Houston, TX, USA.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Danve', 'Affiliation': 'Section of Rheumatology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'Janssen Global Services, LLC, Horsham, PA, USA.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chan', 'Affiliation': 'Patient Reported Outcomes, Janssen Global Services, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05342-7']
2766,32926259,Single-blind randomized clinical trial of transinguinal preperitoneal repair using self-expanding mesh patch vs. Lichtenstein repair for adult male patients with primary unilateral inguinal hernia.,"PURPOSE


The aim of the study was to compare proportions of chronic postoperative inguinal pain (CPIP) and other surgical outcomes between transinguinal preperitoneal repair with modified Kugel patch (MK) and Lichtenstein repair (LR).
METHODS


Two-hundred adult male patients with primary unilateral inguinal hernia were randomized into MK or LR groups. The primary endpoint was CPIP, pain at 6 months after surgery. Secondary outcomes included recurrence rate, incidence of postoperative complications, time until return to activities, inguinal pain and sensory disturbances assessed at 1 week, 1 month, 3, 6, and 12 months after the operation using an 11-point numerical rating scale (NRS). The study was an intention-to-treat analysis.
RESULTS


In comparison of MK (n = 100) and LR (n = 100) with similar backgrounds, proportions of CPIP were similar (7.2 vs. 11.1%, p = 0.3452). Favorable outcomes for MK were duration of operation (32 vs. 40 min, p < 0.0001), NRS of foreign body sensation at 1 year (0 [0-1] vs. 0 [0-2], p = 0.0067), and NRS of numbness at 1 month (0 [0-1] vs. 0 [0-3], p = 0.0078) after the operation.
CONCLUSIONS


In regard to CPIP, the short-term results of MK and LR were similar.",2020,"Favorable outcomes for MK were duration of operation (32 vs. 40 min, p < 0.0001), NRS of foreign body sensation at 1 year (0 [0-1] vs. 0 [0-2], p = 0.0067), and NRS of numbness at 1 month (0","['Two-hundred adult male patients with primary unilateral inguinal hernia', 'adult male patients with primary unilateral inguinal hernia']","['MK', 'transinguinal preperitoneal repair with modified Kugel patch (MK) and Lichtenstein repair (LR', 'transinguinal preperitoneal repair using self-expanding mesh patch vs. Lichtenstein repair', 'MK or LR']","['chronic postoperative inguinal pain (CPIP', 'NRS of numbness', 'recurrence rate, incidence of postoperative complications, time until return to activities, inguinal pain and sensory disturbances', 'CPIP, pain', '11-point numerical rating scale (NRS', 'NRS of foreign body sensation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0442357', 'cui_str': 'Inguinal approach'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0152027', 'cui_str': 'Sensory disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}]",200.0,0.283611,"Favorable outcomes for MK were duration of operation (32 vs. 40 min, p < 0.0001), NRS of foreign body sensation at 1 year (0 [0-1] vs. 0 [0-2], p = 0.0067), and NRS of numbness at 1 month (0","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Suwa', 'Affiliation': 'Department of Surgery, The Jikei University Daisan Hospital, 4-11-1 Izumihoncho, Komae, Tokyo, 201-8601, Japan. katsuhito0124james007@yahoo.co.jp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Onda', 'Affiliation': 'Department of Surgery, The Jikei University Hospital, 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yasuda', 'Affiliation': 'Department of Surgery, The Jikei University Hospital, 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nakajima', 'Affiliation': 'Department of Surgery, The Jikei University Hospital, 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Surgery, The Jikei University Daisan Hospital, 4-11-1 Izumihoncho, Komae, Tokyo, 201-8601, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yanaga', 'Affiliation': 'Department of Surgery, The Jikei University Hospital, 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-020-02301-8']
2767,32926309,Effect of long term CPAP therapy on cardiac parameters assessed with cardiac MRI.,"The obstructive sleep apnoea syndrome (OSAS) is a disorder with a high prevalence and is associated with an elevated cardiovascular risk and increased morbidity and mortality. For longitudinal studies and functional analysis cardiac MRI is regarded as the gold standard. Aim of this study was to evaluate the long-term effect of continuous positive airway pressure (CPAP) therapy on cardiac functional parameters with cardiac Magnetic Resonance Imaging (cMRI). 54 patients with OSAS (mean apnea hypopnea index-AHI: 31) were prospectively enrolled in this study and cMRI was performed before and after 7 months of CPAP therapy. Data were acquired on a 1.5 T MRI and right and left ventricular cardiac function were analysed. CPAP treatment was considered compliant when used ≥ 4 h per night. 24-h blood pressure was measured at baseline and follow up. 33 patients could be assigned to the compliance group. Left ventricular stroke volume (LV SV) and right ventricular ejection fraction (RV EF) improved significantly with CPAP therapy (LV SV from 93 ± 19 to 99 ± 20 ml, p = 0.02; RV EF from 50 ± 6 to 52 ± 6%, p = 0.04). All other cardiac parameters did not change significantly while mean systolic and diastolic blood pressure improved significantly (p < 0.01). 21 patients were assigned to the non-compliance group and were considered as a control group. There were no relevant differences in cardiac parameters between baseline and follow up examination in these patients. CPAP therapy seems to improve LV SV, RV EF, systolic and diastolic blood pressure in OSAS patients, but reproducibility of our results need to be confirmed in a larger patient population.",2020,All other cardiac parameters did not change significantly while mean systolic and diastolic blood pressure improved significantly (p < 0.01).,"['54 patients with OSAS (mean apnea hypopnea index-AHI: 31', '21 patients', '33 patients']","['CPAP therapy (LV SV from 93\u2009±', 'continuous positive airway pressure (CPAP) therapy', 'cardiac Magnetic Resonance Imaging (cMRI', 'CPAP', 'CPAP therapy']","['cardiac parameters', 'obstructive sleep apnoea syndrome (OSAS', '24-h blood pressure', 'mean systolic and diastolic blood pressure', 'Left ventricular stroke volume (LV SV) and right ventricular ejection fraction (RV EF', 'cardiac parameters assessed with cardiac MRI', 'LV SV, RV EF, systolic and diastolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0428781', 'cui_str': 'Right ventricular ejection fraction'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}]",54.0,0.0408762,All other cardiac parameters did not change significantly while mean systolic and diastolic blood pressure improved significantly (p < 0.01).,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wuest', 'Affiliation': 'Radioloical Institute, Friedrich-Alexander-University-Erlangen-Nuremberg, Maximiliansplatz 1, 91054, Erlangen, Germany. wolfgang.wuest@uk-erlangen.de.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'May', 'Affiliation': 'Radioloical Institute, Friedrich-Alexander-University-Erlangen-Nuremberg, Maximiliansplatz 1, 91054, Erlangen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wiesmueller', 'Affiliation': 'Radioloical Institute, Friedrich-Alexander-University-Erlangen-Nuremberg, Maximiliansplatz 1, 91054, Erlangen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uder', 'Affiliation': 'Radioloical Institute, Friedrich-Alexander-University-Erlangen-Nuremberg, Maximiliansplatz 1, 91054, Erlangen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schmid', 'Affiliation': 'Radioloical Institute, Friedrich-Alexander-University-Erlangen-Nuremberg, Maximiliansplatz 1, 91054, Erlangen, Germany.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-02024-y']
2768,32926313,Long-term outcomes of ulcerative interstitial cystitis after complete transurethral resection with therapeutic hydrodistention.,"PURPOSE


We analyzed the long-term efficacy of simultaneous transurethral resection (TUR) and therapeutic hydrodistention in patients with ulcerative interstitial cystitis (IC) who did not experience recurrence on long-term follow-up.
METHODS


We studied 132 female patients (mean age = 56.45 ± 11.56 years) who underwent TUR followed by hydrodistention to treat ulcerative IC between January 2010 and January 2017, and who were available for follow-up, for more than 36 months (mean = 52.3 ± 10.51 months). Of the 132 patients, those who did not suffer recurrence within 36 months after surgery were allocated to group I and those who had a recurrence within the same period were assigned to group II. Preoperative factors, including age, were compared between the groups. In group I, improvements in pain and voiding symptoms were recorded using a 10-point visual analog pain scale (VAS) and a 3-day micturition chart. A global response assessment (GRA) was used to evaluate patient satisfaction.
RESULTS


In group II, the maximum functional bladder capacity (FBC) was smaller, and voiding frequency was higher, than in group I. Follow-up of patients in group I for more than 3 years showed that pain decreased after surgery. The 10-point VAS scores were 9.68 before surgery, and 1.54, 0.93, 0.55, and 0.46 at 1, 6, 12, and 36 months after surgery (p < 0.001), respectively. Maximum FBCs were 174.82 mL before surgery and 237.14, 250.71, and 254.46 mL at 1, 12, and 36 months after surgery (p < 0.001), respectively; thus, FBC increased after surgery. Urination frequency decreased significantly after surgery; the number of daily urinations was 12.77 before surgery, and 9.88, 9.21, and 9.25 at 1, 12, and 36 months after surgery (p < 0.001), respectively. Overall patient satisfaction improved after surgery; the GRA scores were 2.39, 2.71, and 2.8 points at 1, 12, and 36 months after surgery (p < 0.001), respectively.
CONCLUSION


Upon simultaneous performance of TUR and therapeutic hydrodistention in patients with ulcerative IC, 49.2% showed favorable outcomes for 3 years.",2020,"In group II, the maximum functional bladder capacity (FBC) was smaller, and voiding frequency was higher, than in group I. Follow-up of patients in group I for more than 3 years showed that pain decreased after surgery.","['patients with ulcerative IC', '132 female patients (mean age\u2009=\u200956.45\u2009±\u200911.56\xa0years) who underwent TUR followed by hydrodistention to treat ulcerative IC between January 2010 and January 2017, and who were available for follow-up, for more than 36\xa0months (mean\u2009=\u200952.3\u2009±\u200910.51\xa0months', '132 patients, those who did not suffer recurrence within 36\xa0months after surgery were allocated to group', 'patients with ulcerative interstitial cystitis (IC) who did not experience recurrence on long-term follow-up']","['simultaneous transurethral resection (TUR', 'complete transurethral resection with therapeutic hydrodistention']","['Urination frequency', 'Maximum FBCs', 'maximum functional bladder capacity (FBC', 'voiding frequency', 'FBC', 'pain and voiding symptoms', 'ulcerative interstitial cystitis', 'number of daily urinations', 'Overall patient satisfaction', 'GRA scores', '10-point visual analog pain scale (VAS', '10-point VAS scores', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429808', 'cui_str': 'Functional bladder capacity'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",132.0,0.0999857,"In group II, the maximum functional bladder capacity (FBC) was smaller, and voiding frequency was higher, than in group I. Follow-up of patients in group I for more than 3 years showed that pain decreased after surgery.","[{'ForeName': 'Sang Wook', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Jomaru-ro 170, Wonmi-gu, Bucheon, 23268, Republic of Korea.'}, {'ForeName': 'Woong Bin', 'Initials': 'WB', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Jomaru-ro 170, Wonmi-gu, Bucheon, 23268, Republic of Korea.'}, {'ForeName': 'Kwang Woo', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Jomaru-ro 170, Wonmi-gu, Bucheon, 23268, Republic of Korea.'}, {'ForeName': 'Jun Mo', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Jomaru-ro 170, Wonmi-gu, Bucheon, 23268, Republic of Korea.'}, {'ForeName': 'Jae Heon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Moon', 'Affiliation': 'Department of Biostatistics, Clinical Trial Center, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Si Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Jomaru-ro 170, Wonmi-gu, Bucheon, 23268, Republic of Korea. yhkuro@schmc.ac.kr.'}]",International urology and nephrology,['10.1007/s11255-020-02637-1']
2769,32926410,Randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children.,"BACKGROUND


The efficacy of negative pressure wound therapy (NPWT) in the acute management of burns remains unclear. The purpose of this trial was to compare standard Acticoat™ and Mepitel™ dressings with combined Acticoat™, Mepitel™ and continuous NPWT to determine the effect of adjunctive NPWT on re-epithelialization in paediatric burns.
METHODS


This two-arm, single-centre RCT recruited children with acute thermal burns covering less than 5 per cent of their total body surface area. The primary outcome was time to re-epithelialization. Blinded assessments were performed using photographs captured every 3-5 days until discharge. Secondary measures included pain, itch, grafting, perfusion and scar management referrals.
RESULTS


Some 114 patients were randomized. Median time to re-epithelialization was 8 (i.q.r. 7-11) days in the NPWT group and 10 (8-14) days in the control group. In a multivariable model, NPWT decreased the expected time to wound closure by 22 (95 per cent c.i. 7 to 34) per cent (P = 0·005). The risk of referral to scar management was reduced by 60 (18 to 81) per cent (P = 0·013). Four participants in the control group and one in the NPWT group underwent grafting. There were no statistically significant differences between groups in pain, itch or laser Doppler measures of perfusion. Adverse events were rare and minor, although NPWT carried a moderate treatment burden, with ten patients discontinuing early.
CONCLUSION


Adjunctive NPWT hastened re-epithelialization in small-area burn injuries in children, but had a greater treatment burden than standard dressings alone. Registration number: ACTRN12618000256279 ( http://ANZCTR.org.au).",2020,"There were no statistically significant differences between groups in pain, itch or laser Doppler measures of perfusion.","['This two-arm, single-centre RCT recruited children with acute thermal burns covering less than 5 per cent of their total body surface area', 'paediatric burns', '114 patients were randomized', 'small-area thermal burns in children']","['adjunctive NPWT', 'negative pressure wound therapy', 'standard Acticoat™ and Mepitel™ dressings with combined Acticoat™, Mepitel™ and continuous NPWT', 'negative pressure wound therapy (NPWT']","['pain, itch or laser Doppler measures of perfusion', 'time to wound closure', 'time to re-epithelialization', 'risk of referral to scar management', 'pain, itch, grafting, perfusion and scar management referrals', 'Median time to re-epithelialization']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0701836', 'cui_str': 'Thermal burn'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0763683', 'cui_str': 'Acticoat'}, {'cui': 'C0758246', 'cui_str': 'mepitel'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0334221', 'cui_str': 'Re-epithelialization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0556498', 'cui_str': 'Scar management'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",114.0,0.0699598,"There were no statistically significant differences between groups in pain, itch or laser Doppler measures of perfusion.","[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Frear', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cuttle', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health and Social Work, Brisbane, Queensland, Australia.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Chatfield', 'Affiliation': 'Faculty of Medicine, University of Queensland, Herston, Australia.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Kimble', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Griffin', 'Affiliation': ""Centre for Children's Burns and Trauma Research, South Brisbane, Australia.""}]",The British journal of surgery,['10.1002/bjs.11993']
2770,32926423,Effects of thermal softening of endotracheal tubes on postoperative sore throat: A randomized double-blinded trial.,"BACKGROUND


Postoperative throat complications after intubation are undesirable but frequent outcomes. A randomized, double-blinded study was performed to determine whether thermal softening of endotracheal tubes reduced throat complications after intubation.
METHODS


Patients (n= 196) undergoing nasal surgery were randomly allocated into the control group and thermal softening groups. Sore throat and hoarseness were evaluated 1 hour and 24 hours after extubation. The severity of sore throat was evaluated using the numeric rating scale. The primary outcome was the incidence of sore throat 1 hour after extubation and sore throat was defined as a painful or scratchy feeling in the throat. The secondary outcomes were the incidence of hoarseness 1 hour after extubation, the incidence of sore throat and hoarseness 24 hours after extubation, severity of sore throat, and vocal cord injuries.
RESULTS


The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs. 52.7%, P = 0.02). Moreover, thermal softening decreased the mean numeric rating scale score for sore throat in the thermal softening group by 10% an hour after extubation (thermal softening group, 1.29 (95% CI ,0.88-1.70) vs. control group, 2.33 (95% CI ,1.77-2.89); P < 0.01). At 24 hours after extubation, the incidence of sore throat (38.3% vs. 40.7%, P = 0.77) and hoarseness (34.0% vs. 35.2%, 0.95 (0.52-1.74), P = 0.74) were comparable between the two groups.
CONCLUSIONS


Intubation using endotracheal tubes with thermal softening significantly decreased the incidence of sore throat 1 hour after extubation when compared with endotracheal tubes without thermal softening.",2020,"The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs. 52.7%, P = 0.02).",['Patients (n= 196) undergoing nasal surgery'],"['thermal softening of endotracheal tubes', 'control group and thermal softening groups']","['incidence of sore throat 1 hour after extubation and sore throat was defined as a painful or scratchy feeling in the throat', 'hoarseness', 'incidence of hoarseness 1 hour after extubation, the incidence of sore throat and hoarseness 24 hours after extubation, severity of sore throat, and vocal cord injuries', 'throat complications', 'postoperative sore throat', 'incidence of sore throat 1 hour after extubation', 'incidence of sore throat', 'numeric rating scale', 'mean numeric rating scale score for sore throat', 'Sore throat and hoarseness', 'severity of sore throat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3887441', 'cui_str': 'Scratchy sensation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",196.0,0.32656,"The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs. 52.7%, P = 0.02).","[{'ForeName': 'Je Hyuk', 'Initials': 'JH', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Paik', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Armed Forces Capital Hospital, Seongnam, Korea.'}, {'ForeName': 'Ho Geol', 'Initials': 'HG', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13705']
2771,32926462,Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials.,"BACKGROUND


Janus kinase (JAK) inhibition is a new mode of action in atopic dermatitis (AD); clarity about drug class safety considerations in the context of AD is important. Baricitinib, an oral, reversible, selective inhibitor of JAK1/JAK2, is in late-stage development for adult patients with moderate-to-severe AD.
OBJECTIVE


To report pooled safety data for baricitinib in patients with moderate-to-severe AD in the clinical development program including long-term extension (LTE) studies.
METHODS


This analysis included patient-level safety data from 6 double-blinded, randomized, placebo-controlled, studies (one phase 2 and five phase 3), 1 double-blinded, randomized, LTE study, and 1 open-label LTE study, reported in 3 datasets: placebo-controlled, 2-mg - 4-mg extended, and All-bari AD. Safety outcomes include treatment-emergent adverse events, adverse events of special interest, and abnormal laboratory changes. Proportions of patients with events and incidence rates were calculated.
RESULTS


Data were collected for 2531 patients who were given baricitinib for 2247 patient-years (median duration 310 days). The frequency of serious infections, opportunistic infections, and conjunctival disorders was low and similar between treatment groups in the placebo-controlled period. The most common serious infections were eczema herpeticum (n=11, IR=0.5), cellulitis (n=6, IR=0.3) and pneumonia (n=3, IR=0.1). There were 4 opportunistic infections (IR=0.2). No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events, or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients. Frequency of herpes simplex was higher in the 4-mg group (6.1%) versus the 2-mg (3.6%) and placebo group (2.7%); IRs in the extended dataset (2-mg IR=9.6; 4-mg IR=14.5) were lower versus the placebo-controlled dataset (2-mg IR=12.4; 4-mg IR=21.3). In the All-bari AD dataset there were 2 positively adjudicated major adverse cardiovascular events (2-mg group): 2 venous thrombosis events (4-mg group) and one death.
CONCLUSION


This integrated safety analysis in patients with moderate-to-severe AD, confirms the established safety profile of baricitinib.",2020,"No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events, or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients.","['adult patients with moderate-to-severe AD', 'patients with moderate-to-severe AD in the clinical development program including long-term extension (LTE) studies', 'adult patients with atopic dermatitis', '2531 patients who were given baricitinib for 2247 patient-years (median duration 310 days', 'patients with moderate-to-severe AD']","['JAK1/JAK2', 'baricitinib', 'placebo', 'placebo-controlled, 2-mg - 4-mg extended, and All-bari AD']","['frequency of serious infections, opportunistic infections, and conjunctival disorders', 'venous thrombosis events', 'treatment-emergent adverse events, adverse events of special interest, and abnormal laboratory changes', 'Frequency of herpes simplex', 'No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events, or tuberculosis', 'adverse cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033333', 'cui_str': 'Program development'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0009759', 'cui_str': 'Disorder of conjunctiva'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0151664', 'cui_str': 'Gastrointestinal perforation'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]",2531.0,0.212392,"No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events, or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'University Med Cen Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Katoh', 'Affiliation': 'Department of Dermatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Torrelo', 'Affiliation': 'Department of Dermatology, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'De Bruin-Weller', 'Affiliation': 'UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaci', 'Affiliation': 'Comprehensive Center for Inflammation Medicine, University Hospital Schleswig Holstein Campus Luebeck, Ratzeburger Allee, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Medical Dermatology Specialists, Atlanta, GA, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Nunes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Brinker', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Issa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Holzwarth', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gamalo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Riedl', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Janes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16948']
2772,32449003,Dynamics in treatment response and disease progression of metastatic colorectal cancer (mCRC) patients with focus on BRAF status and primary tumor location: analysis of untreated RAS-wild-type mCRC patients receiving FOLFOXIRI either with or without panitumumab in the VOLFI trial (AIO KRK0109).,"PURPOSE


In mCRC, disease dynamics may play a critical role in the understanding of long-term outcome. We evaluated depth of response (DpR), time to DpR, and post-DpR survival as relevant endpoints.
METHODS


We analyzed DpR by central review of computer tomography images (change from baseline to smallest tumor diameter), early tumor shrinkage (≥ 20% reduction in tumor diameter at first reassessment), time to DpR (study randomization to DpR-image), post-DpR progression-free survival (pPFS = DpR-image to tumor progression or death), and post-DpR overall survival (pOS = DpR-image to death) with special focus on BRAF status in 66 patients and primary tumor site in 86 patients treated within the VOLFI-trial, respectively.
RESULTS


BRAF wild-type (BRAF-WT) compared to BRAF mutant (BRAF-MT) patients had greater DpR (- 57.6% vs. - 40.8%, p = 0.013) with a comparable time to DpR [4.0 (95% CI 3.1-4.4) vs. 3.9 (95% CI 2.5-5.5) months; p = 0.8852]. pPFS was 6.5 (95% CI 4.9-8.0) versus 2.6 (95% CI 1.2-4.0) months in favor of BRAF-WT patients (HR 0.24 (95% CI 0.11-0.53); p < 0.001). This transferred into a significant difference in pOS [33.6 (95% CI 26.0-41.3) vs. 5.4 (95% CI 5.0-5.9) months; HR 0.27 (95% CI 0.13-0.55); p < 0.001]. Similar observations were made for patients stratified for primary tumor site.
CONCLUSIONS


BRAF-MT patients derive a less profound treatment response compared to BRAF-WT patients. The difference in outcome according to BRAF status is evident after achievement of DpR with BRAF-MT patients hardly deriving any further disease control beyond DpR. Our observations hint towards an aggressive tumor evolution in BRAF-MT tumors, which may already be molecularly detectable at the time of DpR.",2020,This transferred into a significant difference in pOS [33.6 (95% CI 26.0-41.3) vs. 5.4 (95% CI 5.0-5.9) months; HR 0.27 (95% CI 0.13-0.55); p < 0.001].,"['metastatic colorectal cancer (mCRC) patients with focus on BRAF status and primary tumor location: analysis of untreated RAS-wild-type mCRC patients receiving FOLFOXIRI either with or without', '66 patients and primary tumor site in 86 patients treated within the VOLFI-trial, respectively']","['panitumumab', 'DpR']","['depth of response (DpR), time to DpR, and post-DpR survival', 'DpR', 'pPFS', 'pOS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0475447', 'cui_str': 'Primary tumor site'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1262869', 'cui_str': 'Body position'}]",66.0,0.135141,This transferred into a significant difference in pOS [33.6 (95% CI 26.0-41.3) vs. 5.4 (95% CI 5.0-5.9) months; HR 0.27 (95% CI 0.13-0.55); p < 0.001].,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kurreck', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology (CVK/CCM), Charité University Medicine Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Geissler', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Klinik für Innere Medizin III, SLK-Kliniken Heilbronn, Heilbronn, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Riera-Knorrenschild', 'Affiliation': 'Universitätsklinik Marburg, Marburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Greeve', 'Affiliation': 'St. Vincenz-Krankenhaus Paderborn, Paderborn, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Florschütz', 'Affiliation': 'Stadtisches Klinikum Dessau, Dessau, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wessendorf', 'Affiliation': 'Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ettrich', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kanzler', 'Affiliation': 'Leopoldina Krankenhaus, Schweinfurt, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nörenberg', 'Affiliation': 'Medical Faculty Mannheim, Institute of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Seidensticker', 'Affiliation': 'Klinik Und Poliklinik für Radiologie, LMU Klinikum, München, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess, Leverkusen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Buechner-Steudel', 'Affiliation': 'Universitätsklinikum Halle (Saale), Halle, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Atzpodien', 'Affiliation': 'Franziskus-Hospital Harderberg, Georgsmarienhütte, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III and Comprehensive Cancer Center, University Hospital Munich (LMU), Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology (CVK/CCM), Charité University Medicine Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tannapfel', 'Affiliation': 'Institute of Pathology, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Reinacher-Schick', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, St. Josef Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology (CVK/CCM), Charité University Medicine Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. dominik.modest@charite.de.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03257-z']
2773,32496738,Microvascular Function Is Impaired after Short-Term Immobilization in Healthy Men.,"PURPOSE


We examined whether 2 wk of one-leg immobilization would impair leg microvascular function and to what extent a subsequent period of intense aerobic cycle training could restore function.
METHODS


Study participants were healthy young men (n = 12; 20-24 yr of age). Leg microvascular function was determined before the intervention, after the immobilization period, and after a 4-wk exercise training period. Microvascular function was assessed as the vasodilator response to intra-arterial infusion of acetylcholine and sodium nitroprusside and as the vasoconstrictor response to endogenous noradrenaline release induced by tyramine infusion. Vasodilator enzymes as well as prooxidant and antioxidant enzymes were assessed by protein analysis in skeletal muscle samples: endothelial nitric oxide synthase, NADPH oxidase (NOX p67 and NOX gp91), and superoxide dismutase 2 (SOD2).
RESULTS


The acetylcholine-induced change in vascular conductance was reduced after the 2 wk of immobilization (P = 0.003), tended to increase (P = 0.061), and was back to baseline levels after the subsequent 4 wk of exercise training. Plasma prostacyclin levels in response to acetylcholine infusion were lower after immobilization than before (P = 0.041). The changes in vascular conductance with sodium nitroprusside and tyramine were similar during all conditions. Skeletal muscle protein levels of endothelial nitric oxide synthase in the experimental leg were unchanged with immobilization and subsequent training but increased 47% in the control leg with training (P = 0.002). NOX p67, NOX gp91, and SOD2 in the experimental leg remained unaltered with immobilization, and SOD2 was higher than preimmobilization after 4 wk of training (P < 0.001).
CONCLUSIONS


The study shows that 2 wk of immobilization impairs leg microvascular endothelial function and prostacyclin formation but that 4 wk of intense aerobic exercise training restores the function. The underlying mechanism may reside in the prostacyclin system.",2020,Plasma prostacyclin levels in response to acetylcholine infusion were lower after immobilization than before (P = 0.041).,"['Healthy Men', 'Study participants were healthy young men (n = 12; 20-24 yr of age']","['acetylcholine and sodium nitroprusside', 'aerobic exercise training', 'immobilization']","['Microvascular Function', 'vascular conductance', 'leg microvascular function', 'Plasma prostacyclin levels', 'Microvascular function', 'Skeletal muscle protein levels of endothelial nitric oxide synthase', 'Leg microvascular function', 'NOX p67, NOX gp91, and SOD2 in the experimental leg remained unaltered with immobilization, and SOD2', 'leg microvascular endothelial function and prostacyclin formation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0033567', 'cui_str': 'Epoprostenol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C1433609', 'cui_str': 'METAP2 protein, human'}, {'cui': 'C0968147', 'cui_str': 'superoxide dismutase 2'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0307898,Plasma prostacyclin levels in response to acetylcholine infusion were lower after immobilization than before (P = 0.041).,"[{'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Rytter', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, DENMARK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Piil', 'Affiliation': ''}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nyberg', 'Affiliation': ''}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Hellsten', 'Affiliation': ''}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Gliemann', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002369']
2774,32673309,Consistent sleep onset and maintenance of body weight after weight loss: An analysis of data from the NoHoW trial.,"BACKGROUND


Several studies have suggested that reduced sleep duration and quality are associated with an increased risk of obesity and related metabolic disorders, but the role of sleep in long-term weight loss maintenance (WLM) has not been thoroughly explored using prospective data.
METHODS AND FINDINGS


The present study is an ancillary study based on data collected on participants from the Navigating to a Healthy Weight (NoHoW) trial, for which the aim was to test the efficacy of an evidence-based digital toolkit, targeting self-regulation, motivation, and emotion regulation, on WLM among 1,627 British, Danish, and Portuguese adults. Before enrolment, participants had achieved a weight loss of ≥5% and had a BMI of ≥25 kg/m2 prior to losing weight. Participants were enrolled between March 2017 and March 2018 and followed during the subsequent 12-month period for change in weight (primary trial outcome), body composition, metabolic markers, diet, physical activity, sleep, and psychological mediators/moderators of WLM (secondary trial outcomes). For the present study, a total of 967 NoHoW participants were included, of which 69.6% were women, the mean age was 45.8 years (SD 11.5), the mean baseline BMI was 29.5 kg/m2 (SD 5.1), and the mean weight loss prior to baseline assessments was 11.4 kg (SD 6.4). Objectively measured sleep was collected using the Fitbit Charge 2 (FC2), from which sleep duration, sleep duration variability, sleep onset, and sleep onset variability were assessed across 14 days close to baseline examinations. The primary outcomes were 12-month changes in body weight (BW) and body fat percentage (BF%). The secondary outcomes were 12-month changes in obesity-related metabolic markers (blood pressure, low- and high-density lipoproteins [LDL and HDL], triglycerides [TGs], and glycated haemoglobin [HbA1c]). Analysis of covariance and multivariate linear regressions were conducted with sleep-related variables as explanatory and subsequent changes in BW, BF%, and metabolic markers as response variables. We found no evidence that sleep duration, sleep duration variability, or sleep onset were associated with 12-month weight regain or change in BF%. A higher between-day variability in sleep onset, assessed using the standard deviation across all nights recorded, was associated with weight regain (0.55 kg per hour [95% CI 0.10 to 0.99]; P = 0.016) and an increase in BF% (0.41% per hour [95% CI 0.04 to 0.78]; P = 0.031). Analyses of the secondary outcomes showed that a higher between-day variability in sleep duration was associated with an increase in HbA1c (0.02% per hour [95% CI 0.00 to 0.05]; P = 0.045). Participants with a sleep onset between 19:00 and 22:00 had the greatest reduction in diastolic blood pressure (DBP) (P = 0.02) but also the most pronounced increase in TGs (P = 0.03). The main limitation of this study is the observational design. Hence, the observed associations do not necessarily reflect causal effects.
CONCLUSION


Our results suggest that maintaining a consistent sleep onset is associated with improved WLM and body composition. Sleep onset and variability in sleep duration may be associated with subsequent change in different obesity-related metabolic markers, but due to multiple-testing, the secondary exploratory outcomes should be interpreted cautiously.
TRIAL REGISTRATION


The trial was registered with the ISRCTN registry (ISRCTN88405328).",2020,Analyses of the secondary outcomes showed that a higher between-day variability in sleep duration was associated with an increase in HbA1c (0.02% per hour [95% CI 0.00 to 0.05]; P = 0.045).,"['967 NoHoW participants were included, of which 69.6% were women, the mean age was 45.8 years (SD 11.5), the mean baseline BMI was 29.5 kg/m2 (SD 5.1), and the mean weight loss prior to baseline assessments was 11.4 kg (SD 6.4', 'Participants were enrolled between March 2017 and March 2018 and followed during the subsequent 12-month period for change in weight (primary trial outcome', '1,627 British, Danish, and Portuguese adults', 'participants from the Navigating to a Healthy Weight (NoHoW) trial']",[],"['weight loss', '12-month changes in body weight (BW) and body fat percentage (BF', 'sleep duration, sleep duration variability, or sleep onset', 'BF', 'diastolic blood pressure (DBP', '12-month changes in obesity-related metabolic markers (blood pressure, low- and high-density lipoproteins [LDL and HDL], triglycerides [TGs], and glycated haemoglobin [HbA1c', 'body composition, metabolic markers, diet, physical activity, sleep, and psychological mediators/moderators of WLM', 'weight regain', 'sleep duration', 'WLM and body composition', 'sleep duration, sleep duration variability, sleep onset, and sleep onset variability', 'HbA1c']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",967.0,0.142814,Analyses of the secondary outcomes showed that a higher between-day variability in sleep duration was associated with an increase in HbA1c (0.02% per hour [95% CI 0.00 to 0.05]; P = 0.045).,"[{'ForeName': 'Sofus C', 'Initials': 'SC', 'LastName': 'Larsen', 'Affiliation': 'Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Aberdeen, United Kingdom.'}, {'ForeName': 'Marie-Louise K', 'Initials': 'MK', 'LastName': 'Mikkelsen', 'Affiliation': 'Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark.'}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Palmeira', 'Affiliation': 'Centro Interdisciplinar para o Estudo da Performance Humana, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Duarte', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Santos', 'Affiliation': 'Centro Interdisciplinar para o Estudo da Performance Humana, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Encantado', 'Affiliation': 'Centro Interdisciplinar para o Estudo da Performance Humana, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Ruairi', 'Initials': 'R', 'LastName': ""O'Driscoll"", 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Turicchi', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Michalowska', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'R James', 'Initials': 'RJ', 'LastName': 'Stubbs', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Berit L', 'Initials': 'BL', 'LastName': 'Heitmann', 'Affiliation': 'Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark.'}]",PLoS medicine,['10.1371/journal.pmed.1003168']
2775,32936795,Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho.,"BACKGROUND


Current World Health Organization (WHO) antiretroviral therapy (ART) guidelines define virologic failure as two consecutive viral load (VL) measurements ≥1,000 copies/mL, triggering empiric switch to next-line ART. This trial assessed if patients with sustained low-level HIV-1 viremia on first-line ART benefit from a switch to second-line treatment.
METHODS AND FINDINGS


This multicenter, parallel-group, open-label, superiority, randomized controlled trial enrolled patients on first-line ART containing non-nucleoside reverse transcriptase inhibitors (NNRTI) with two consecutive VLs ≥100 copies/mL, with the second VL between 100-999 copies/mL, from eight clinics in Lesotho. Consenting participants were randomly assigned (1:1), stratified by facility, demographic group, and baseline VL, to either switch to second-line ART (switch group) or continued first-line ART (control group; WHO guidelines). The primary endpoint was viral suppression (<50 copies/mL) at 36 weeks. Analyses were by intention to treat, using logistic regression models, adjusted for demographic group and baseline VL. Between August 1, 2017, and August 7, 2019, 137 individuals were screened, of whom 80 were eligible and randomly assigned to switch (n = 40) or control group (n = 40). The majority of participants were female (54 [68%]) with a median age of 42 y (interquartile range [IQR] 35-51), taking tenofovir disoproxil fumarate/lamivudine/efavirenz (49 [61%]) and on ART for a median of 5.9 y (IQR 3.3-8.6). At 36 weeks, 22/40 (55%) participants in the switch versus 10/40 (25%) in the control group achieved viral suppression (adjusted difference 29%, 95% CI 8%-50%, p = 0.009). The switch group had significantly higher probability of viral suppression across different VL thresholds (<20, <100, <200, <400, and <600 copies/mL) but not for <1,000 copies/mL. Thirty-four (85%) participants in switch group and 21 (53%) in control group experienced at least one adverse event (AE) (p = 0.002). No hospitalization or death or other serious adverse events were observed. Study limitations include a follow-up period too short to observe differences in clinical outcomes, missing values in CD4 cell counts due to national stockout of reagents during the study, and limited generalizability of findings to other than NNRTI-based first-line ART regimens.
CONCLUSIONS


In this study, switching to second-line ART among patients with sustained low-level HIV-1 viremia resulted in a higher proportion of participants with viral suppression. These results endorse lowering the threshold for virologic failure in future WHO guidelines.
TRIAL REGISTRATION


The trial is registered at ClinicalTrials.gov, NCT03088241.",2020,No hospitalization or death or other serious adverse events were observed.,"['enrolled patients on first-line ART containing non-nucleoside reverse transcriptase inhibitors (NNRTI) with two consecutive VLs ≥100 copies/mL, with the second VL between 100-999 copies/mL, from eight clinics in Lesotho', 'Consenting participants', 'patients with sustained low-level HIV-1 viremia on first-line ART benefit from a switch to second-line treatment', '49 [61%]) and on ART for a median of 5.9 y (IQR 3.3-8.6', 'patients with low-level HIV-1 viremia', 'Between August 1, 2017, and August 7, 2019, 137 individuals were screened, of whom 80 were eligible and randomly assigned to switch (n = 40) or control group (n = 40', 'participants were female (54 [68%]) with a median age of 42 y (interquartile range [IQR] 35-51), taking']","['tenofovir disoproxil fumarate/lamivudine/efavirenz', 'switch to second-line ART (switch group) or continued first-line ART', 'Current World Health Organization (WHO) antiretroviral therapy']","['hospitalization or death or other serious adverse events', 'viral suppression', 'probability of viral suppression', 'virologic failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3541376', 'cui_str': 'Non-nucleoside reverse transcriptase inhibitors'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}]",137.0,0.276927,No hospitalization or death or other serious adverse events were observed.,"[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Bienvenu Lengo', 'Initials': 'BL', 'LastName': 'Nsakala', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Namane', 'Affiliation': 'Motebang Government Hospital, Leribe, Lesotho.'}, {'ForeName': 'Tlali', 'Initials': 'T', 'LastName': 'Mpholo', 'Affiliation': 'Senkatana HIV Clinic, Maseru, Lesotho.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",PLoS medicine,['10.1371/journal.pmed.1003325']
2776,32936837,Implementation of a complex intervention to improve care for patients whose situations are clinically uncertain in hospital settings: A multi-method study using normalisation process theory.,"PURPOSE


To examine the use of Normalisation Process Theory (NPT) to establish if, and in what ways, the AMBER care bundle can be successfully normalised into acute hospital practice, and to identify necessary modifications to optimise its implementation.
METHOD


Multi-method process evaluation embedded within a mixed-method feasibility cluster randomised controlled trial in two district general hospitals in England. Data were collected using (i) focus groups with health professionals (HPs), (ii) semi-structured interviews with patients and/or carers, (iii) non-participant observations of multi-disciplinary team meetings and (iv) patient clinical note review. Thematic analysis and descriptive statistics, with interpretation guided by NPT components (coherence; cognitive participation; collective action; reflexive monitoring). Data triangulated across sources.
RESULTS


Two focus groups (26 HPs), nine non-participant observations, 12 interviews (two patients, 10 relatives), 29 clinical note reviews were conducted. While coherence was evident, with HPs recognising the value of the AMBER care bundle, cognitive participation and collective action presented challenges. Specifically: (1) HPs were unable and unwilling to operationalise the concept of 'risk of dying' intervention eligibility criteria (2) integration relied on a 'champion' to drive participation and ensure sustainability; and (3) differing skills and confidence led to variable engagement with difficult conversations with patients and families about, for example, nearness to end of life. Opportunities for reflexive monitoring were not routinely embedded within the intervention. Reflections on the use of the AMBER care bundle from HPs and patients and families, including recommended modifications became evident through this NPT-driven analysis.
CONCLUSION


To be successfully normalised, new clinical practices, such as the AMBER care bundle, must be studied within the wider context in which they operate. NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.",2020,NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.,"['Two focus groups (26 HPs), nine non-participant observations, 12 interviews (two patients, 10 relatives), 29 clinical note reviews were conducted', 'two district general hospitals in England', 'patients whose situations are clinically uncertain in hospital settings']","['Normalisation Process Theory (NPT', 'complex intervention', 'health professionals (HPs), (ii) semi-structured interviews with patients and/or carers, (iii) non-participant observations of multi-disciplinary team meetings and (iv) patient clinical note review', 'NPT']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0589031', 'cui_str': 'Team meeting'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",[],2.0,0.0411618,NPT can be used to the aid identification of practical strategies to assist in normalisation of complex interventions where the focus of care is on clinical uncertainty in acute hospital settings.,"[{'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yorganci', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, Cambridgeshire, United Kingdom.'}, {'ForeName': 'Fliss E M', 'Initials': 'FEM', 'LastName': 'Murtagh', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Sampson', 'Affiliation': 'Marie Curie Palliative Care Research Department, University College London, London, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Droney', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Farquhar', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Koffman', 'Affiliation': ""Cicely Saunders Institute, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.""}]",PloS one,['10.1371/journal.pone.0239181']
2777,32936872,"Exploring changes in the human gut microbiota and microbial-derived metabolites in response to diets enriched in simple, refined, or unrefined carbohydrate-containing foods: a post hoc analysis of a randomized clinical trial.","BACKGROUND


Dietary carbohydrate type may influence cardiometabolic risk through alterations in the gut microbiome and microbial-derived metabolites, but evidence is limited.
OBJECTIVES


We explored the relative effects of an isocaloric exchange of dietary simple, refined, and unrefined carbohydrate on gut microbiota composition/function, and selected microbial metabolite concentrations.
METHODS


Participants [n = 11; age: 65 ± 8 y; BMI (in kg/m2): 29.8 ± 3.2] were provided with each of 3 diets for 4.5 wk with 2-wk washout, according to a randomized, crossover design. Diets [60% of energy (%E) carbohydrate, 15%E protein, and 25%E fat] differed in type of carbohydrate. Fecal microbial composition, metatranscriptomics, and microbial-derived SCFA and secondary bile acid (SBA) concentrations were assessed at the end of each phase and associated with cardiometabolic risk factors (CMRFs).
RESULTS


Roseburia abundance was higher (11% compared with 5%) and fecal SBA concentrations were lower (lithocolic acid -50% and deoxycholic acid -64%) after consumption of the unrefined carbohydrate diet relative to the simple carbohydrate diet [false discovery rate (FDR): all P < 0.05), whereas Anaerostipes abundance was higher (0.35% compared with 0.12%; FDR: P = 0.04) after the simple carbohydrate diet relative to the refined carbohydrate diet. Metatranscriptomics indicated upregulation of 2 cellular stress genes (FDR: P < 0.1) after the unrefined carbohydrate diet compared with the simple carbohydrate or refined carbohydrate diets. The microbial expression of 3 cellular/oxidative stress and immune response genes was higher (FDR: P < 0.1) after the simple carbohydrate diet relative to the refined carbohydrate diet. No significant diet effect was observed in fecal SCFA concentrations. Independent of diet, we observed 16 associations (all FDR: P < 0.1) of taxon abundance (15 phylum and 1 genera) with serum inflammatory markers and also with fecal SCFA and SBA concentrations.
CONCLUSIONS


Consuming an unrefined carbohydrate-rich diet had a modest effect on the gut microbiome and SBAs, resulting in favorable associations with selected CMRFs. Simple carbohydrate- and refined carbohydrate-rich diets have distinctive effects on the gut microbiome, suggesting differential mechanisms mediate their effects on cardiometabolic health. This trial was registered at clinicaltrials.gov as NCT01610661.",2020,The microbial expression of 3 cellular/oxidative stress and immune response genes was higher (FDR: P < 0.1) after the simple carbohydrate diet relative to the refined carbohydrate diet.,"['11; age: 65\xa0±\xa08 y; BMI (in kg/m2): 29.8\xa0±\xa03.2', 'Participants [n\xa0']","['Simple carbohydrate- and refined carbohydrate-rich diets', 'isocaloric exchange of dietary simple, refined, and unrefined carbohydrate']","['microbial expression of 3 cellular/oxidative stress and immune response genes', 'Roseburia abundance', 'Fecal microbial composition, metatranscriptomics, and microbial-derived SCFA and secondary bile acid (SBA) concentrations', 'Anaerostipes abundance', 'fecal SBA concentrations', 'gut microbiome and SBAs', 'fecal SCFA concentrations']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0175898', 'cui_str': 'Refined carbohydrate'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0086344', 'cui_str': 'Immune response gene'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1224225', 'cui_str': 'Anaerostipes'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.0400471,The microbial expression of 3 cellular/oxidative stress and immune response genes was higher (FDR: P < 0.1) after the simple carbohydrate diet relative to the refined carbohydrate diet.,"[{'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Faits', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Maura E', 'Initials': 'ME', 'LastName': 'Walker', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rodriguez-Morato', 'Affiliation': 'Pompeu Fabra University, Barcelona, Spain.'}, {'ForeName': 'Huicui', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Gervis', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Galluccio', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'W Evan', 'Initials': 'WE', 'LastName': 'Johnson', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa254']
2778,32936874,A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX.,"BACKGROUND


In a previous phase II study an immunonutrient supplement was found to reduce severe acute toxicities for head and neck squamous cell cancer (HNSCC) patients treated with concomitant cisplatin and radiotherapy.
OBJECTIVES


The primary objective of the present study was to evaluate efficacy of the same immunonutrient supplement on severe mucositis. Secondary objectives included tolerance, compliance to oral supplementation, chemotherapy interruptions and delays, quality of life, and progression-free survival (PFS) and overall survival (OS) at 1, 2, and 3 y.
METHODS


Between November 2009 and June 2013, 180 HNSCC patients eligible for adjuvant chemotherapy after surgery with curative intent were included in our double-blind phase III multicenter trial. They were assigned to receive oral supplementation (3 sachets/d) of either a formula enriched with l-arginine and omega-3 (n-3) fatty and ribonucleic acids (experimental arm), or an isocaloric isonitrogenous control (control arm), for 5 d before each of 3 cycles of cisplatin. Intention-to-treat (ITT) and per-protocol (PP) analyses were undertaken, along with subgroup analyses of ≥75% compliant patients, to compare the incidence of acute mucositis (Radiation Therapy Oncology Group and WHO scales) and 36-mo survival.
RESULTS


At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses. The immunomodulating supplement did not significantly improve survival in the ITT and PP analyses at 3 y after CRT. Among ≥75% compliant patients, however, OS at 3 y was significantly improved in the immunomodulating formula group (81%; 95% CI: 67%, 89%) compared with controls (61%; 95% CI: 46%, 73%; P = 0.034), as well as PFS (73%; 95% CI: 58%, 83% compared with 50%; 95% CI: 36%, 63%; P = 0.012).
CONCLUSIONS


Although this immunomodulating formula failed to reduce severe mucositis during CRT, the findings suggest that the long-term survival of compliant HNSCC patients was improved.This trial was registered at clinicaltrials.gov as NCT01149642.",2020,"At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses.","['180 HNSCC patients eligible for adjuvant chemotherapy after surgery with curative intent', 'head and neck squamous cell cancer (HNSCC) patients treated with', 'head and neck cancer patients']","['oral supplementation (3 sachets/d) of either a formula enriched with l-arginine and omega-3 (n-3) fatty and ribonucleic acids (experimental arm), or an isocaloric isonitrogenous control', 'cisplatin', 'adjuvant chemoradiotherapy', 'chemoradiotherapy (CRT', 'concomitant cisplatin and radiotherapy', 'immunomodulating nutritional formula', 'immunonutrient supplement']","['severe acute toxicities', 'incidence of grade 3-4 mucositis', 'severe mucositis', 'tolerance, compliance to oral supplementation, chemotherapy interruptions and delays, quality of life, and progression-free survival (PFS) and overall survival (OS', 'survival']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",180.0,0.559447,"At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Radiotherapy Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': 'Radiotherapy Department, Lorraine Cancer Institute, Vandœuvre-Lès-Nancy, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thézenas', 'Affiliation': 'Biometrics Unit, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Gallocher', 'Affiliation': 'Radiotherapy Department, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lavau-Denes', 'Affiliation': 'Clinical Research Unit, Dupuytren University Hospital, Limoges, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Garcia-Ramirez', 'Affiliation': 'Radiotherapy Department, Libourne Hospital Center, Libourne, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Radiotherapy Department, Sainte Catherine Institute, Avignon, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': 'Oncology Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'de Forges', 'Affiliation': 'Clinical Research and Innovation Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Janiszewski', 'Affiliation': 'Clinical Research and Innovation Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Radiotherapy Department, Lorraine Cancer Institute, Vandœuvre-Lès-Nancy, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Radiotherapy Department, Bretagne Sud Hospital, Lorient, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Senesse', 'Affiliation': 'Clinical Nutrition and Gastroenterology Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa227']
2779,32937008,Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol.,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin-converting enzyme 2 (ACE2), which facilitates SARS-CoV-2 host cell entry, may be impacted by angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that began enrollment on March 31, 2020, participants are randomized to continuation vs withdrawal of their long-term outpatient ACEI or ARB upon hospitalization with COVID-19. The primary outcome is a hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity. Approval for the study has been obtained from the Institutional Review Board of each participating institution, and all participants will provide informed consent. A data safety monitoring board has been assembled to provide independent oversight of the project.",2020,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death.",[],"['Angiotensin-converting enzyme 2 (ACE2', 'ACE inhibitors and ARBs']","['hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity']",[],"[{'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.173724,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death.","[{'ForeName': 'Jordana B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Hanff', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Corrales-Medina', 'Affiliation': 'Division of Infectious Diseases, University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'William', 'Affiliation': 'Division of Cardiology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Renna', 'Affiliation': 'Hypertension Unit, Department of Pathology, Hospital Español de Mendoza, National University of Cuyo, IMBECU-CONICET, Mendoza, Argentina.'}, {'ForeName': 'Nelson R', 'Initials': 'NR', 'LastName': 'Rosado-Santander', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Rodriguez-Mori', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Spaak', 'Affiliation': 'Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Andrade-Villanueva', 'Affiliation': 'Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Barbagelata', 'Affiliation': 'Universidad Católica de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Alfonso', 'Affiliation': 'Cardiology Division, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bernales-Salas', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Coacalla', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú.'}, {'ForeName': 'Carlos Augusto', 'Initials': 'CA', 'LastName': 'Castro-Callirgos', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Tupayachi-Venero', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Medina', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Valdivia', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Villavicencio', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Vasquez', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Harhay', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Sharkoski', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'James Brian', 'Initials': 'JB', 'LastName': 'Byrd', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edmonston', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sweitzer', 'Affiliation': 'Division of Cardiology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14011']
2780,32937016,Performance and Predictors of Minimal Disease Activity Response in Peripheral Spondyloarthritis Patients Treated With Adalimumab.,"OBJECTIVES


To examine concurrent validity and discrimination of modified minimal disease activity (mMDA) criteria in peripheral spondyloarthritis (pSpA) following OMERACT filter principles and determine predictors of mMDA response.
METHODS


Four mMDA versions were derived in the ABILITY-2 study using the SPondyloArthritis Research Consortium of Canada (SPARCC) or Leeds Enthesitis Index (LEI) but excluding psoriasis. To assess concurrent validity, mMDA versions were correlated with Peripheral SpondyloArthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score for inactive disease (ASDAS ID), and physician global. Treatment discrimination was assessed between adalimumab and placebo at week 12. Multiple logistic regression was used to determine baseline predictors of long-term mMDA responses and sustained mMDA.
RESULTS


The four mMDA versions showed a stronger positive correlation with PSpARC remission (r tet  >0.95) versus ASDAS ID (r tet  >0.75) at week 12 and years 1-3 and were able to show discrimination (p<0.001). Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all four versions of mMDA. Approximately 40-60% of adalimumab-treated patients achieved mMDA-LEI or SPARCC at years 1-3. Achieving mMDA response after 12 weeks of adalimumab treatment was a robust positive predictor of attaining long-term mMDA through 3 years (odds ratios: 11.38-27.13 for mMDA-LEI; 17.98-37.85 for mMDA-SPARCC).
CONCLUSIONS


All four versions of mMDA showed concurrent validity and discriminated well between adalimumab and placebo treatment groups. Early mMDA response is a more consistent predictor of long-term mMDA achievement than baseline characteristics. The 5 of 6 versions of mMDA could be an appropriate treatment target in pSpA patients.",2020,Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all four versions of mMDA.,"['Four mMDA versions were derived in the ABILITY-2 study using the SPondyloArthritis Research Consortium of Canada (SPARCC) or Leeds Enthesitis Index (LEI) but excluding psoriasis', 'Peripheral Spondyloarthritis Patients Treated With']","['adalimumab', 'Adalimumab', 'adalimumab and placebo', 'placebo']","['PSpARC remission', 'mMDA-LEI or SPARCC', 'Achieving mMDA response', 'Peripheral SpondyloArthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score for inactive disease (ASDAS ID), and physician global', 'Performance and Predictors of Minimal Disease Activity Response']","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0451148', 'cui_str': 'Enthesitis index'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4511579', 'cui_str': 'Peripheral spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4511579', 'cui_str': 'Peripheral spondyloarthritis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451148', 'cui_str': 'Enthesitis index'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.111974,Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all four versions of mMDA.,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Abraham', 'Affiliation': 'NIHR/Wellcome CRF, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Royal National Hospital for Rheumatic Diseases, Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St, Joseph Health and University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ramiro', 'Affiliation': 'Leiden University Medical Center, Leiden, and Zuyderland Medical Center, Heerlen, the Netherlands.'}, {'ForeName': 'Tianshuang', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, IL, United States.'}]",Arthritis care & research,['10.1002/acr.24442']
2781,32937023,Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia.,"Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low-density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow-up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least-Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were -19.3 (2.68) mm Hg and -6.69 (2.76) mm Hg. The difference between the two groups was significant (-12.60 (2.77) mm Hg, 95% CI -18.06 to -7.14, P < .0001). The LS Mean for the percent changes from baseline in LDL cholesterol in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups were -52.45 (3.23) % and 2.68 (3.15) %. The difference between the two groups was significant (-55.13 (3.20) %, 95% CI -61.45 to -48.81, P < .0001). There were no adverse events leading to discontinuation or death. Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688.",2020,"The difference between the two groups was significant (-55.13 (3.20) %, 95% CI -61.45 to -48.81, P ","['subjects with hypertension and dyslipidemia', 'hypertensive patients with dyslipidemia', '202 patients']","['mg\xa0+\xa0rosuvastatin 20\xa0mg and telmisartan 80\xa0mg\xa0+\xa0rosuvastatin', 'mg\xa0+\xa0rosuvastatin 20\xa0mg and telmisartan/amlodipine 80/5', 'telmisartan/amlodipine 80/5', 'rosuvastatin', 'co-administered telmisartan/amlodipine and rosuvastatin', 'mg\xa0+\xa0rosuvastatin', 'mg\xa0+\xa0rosuvastatin 20\xa0mg and telmisartan 80\xa0mg\xa0+\xa0rosuvastatin 20\xa0mg', 'telmisartan/amlodipine', 'telmisartan 80\xa0mg\xa0+\xa0rosuvastatin 20\xa0mg, and telmisartan/amlodipine 80/5']","['low-density lipoprotein (LDL) cholesterol', 'changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels', 'LDL cholesterol', 'mean overall treatment compliance', 'Efficacy and safety', 'mean sitting systolic blood pressure (MSSBP', 'blood pressure and improves lipid control']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C5136931', 'cui_str': 'rosuvastatin 20 MG [Ezallor]'}, {'cui': 'C0990503', 'cui_str': 'telmisartan 80 MG'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319893', 'cui_str': 'Sitting systolic blood pressure'}, {'cui': 'C1319894', 'cui_str': 'Sitting diastolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",202.0,0.0171147,"The difference between the two groups was significant (-55.13 (3.20) %, 95% CI -61.45 to -48.81, P ","[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Dong-A University Hospital, Busan, Korea.'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Dong-A University Hospital, Busan, Korea.'}, {'ForeName': 'Ki Hoon', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Cheon', 'Initials': 'JC', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea.'}, {'ForeName': 'Jung-Hoon', 'Initials': 'JH', 'LastName': 'Sung', 'Affiliation': 'Department of Cardiology, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Jin-Man', 'Initials': 'JM', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.'}, {'ForeName': 'Han Cheol', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Kyounghoon', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Woo-Shik', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University Hospital, Seoul, Korea.'}, {'ForeName': 'Moo-Yong', 'Initials': 'MY', 'LastName': 'Rhee', 'Affiliation': 'Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Ju Han', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Seung Pyo', 'Initials': 'SP', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Daegu Catholic University Medical Center, Daegu, Korea.'}, {'ForeName': 'Byung Su', 'Initials': 'BS', 'LastName': 'Yoo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Eun Joo', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Jae-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology in Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Pum-Joon', 'Initials': 'PJ', 'LastName': 'Kim', 'Affiliation': ""Department of Internal Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Chang-Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Min Su', 'Initials': 'MS', 'LastName': 'Hyon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Ki Chul', 'Initials': 'KC', 'LastName': 'Sung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Jinyong', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Kihwan', 'Initials': 'K', 'LastName': 'Kwon', 'Affiliation': 'Department of Cardiology, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Jeong-Sook', 'Initials': 'JS', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Hyungseop', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Yuhan Research Institute, Yuhan Corporation, Yongin, Korea.'}, {'ForeName': 'Yoonhwa', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': 'Yuhan Research Institute, Yuhan Corporation, Yongin, Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13893']
2782,32926219,[Disease-related knowledge acquisition through structured patient information in rheumatoid arthritis (StruPI-RA) : First results of the StruPI-RA study in Germany].,"BACKGROUND/OBJECTIVE


The structured patient information for rheumatoid arthritis (StruPi-RA) program was the first standardized outpatient education program in rheumatoid arthritis (RA) in Germany. The main objective of the study was to determine the efficacy of the StruPi-RA program concerning disease-specific knowledge acquisition in patients with early stage RA or after changing the treatment regimen.
METHODS


A total of 61 patients were included in a control group design, 32 in the intervention group (IG) and 29 in the control group (CG). Patients of the IG attended 3 modules of 90 min in a structured patient information program (StruPI-RA) including the topics of diagnostics, treatment and living with RA. Patients in the CG only received information material from the German Rheumatism League. The primary target criterion was the disease-related acquisition of knowledge, measured with the patient knowledge questionnaire (PKQ). Data were collected before and after participation in StruPI-RA.
RESULTS


The improvement in knowledge in the IG attending the StruPI-RA compared to the CG was significant in time and group comparisons. No influence of disease duration or educational level was observed. The subscale treatment alone showed a significant difference in the group and time comparison.
CONCLUSION


Participation in the StruPI-RA program in early RA was associated with a significant increase in disease-specific knowledge compared to the control group of patients. This leads to better decision-making in terms of treatment, a more beneficial doctor-patient communication and better self-management. In the long term an improvement in treatment adherence and quality of life is expected.",2020,The improvement in knowledge in the IG attending the StruPI-RA compared to the CG was significant in time and group comparisons.,"['rheumatoid arthritis (RA) in Germany', 'patients with early stage RA or after changing the treatment regimen', 'A total of 61\xa0patients were included in a\xa0control group design, 32 in the intervention group (IG) and 29 in the control group (CG']",['StruPi-RA program'],"['knowledge', 'disease duration or educational level', 'disease-related acquisition of knowledge, measured with the patient knowledge questionnaire (PKQ', 'disease-specific knowledge', 'treatment adherence and quality of life']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.0219963,The improvement in knowledge in the IG attending the StruPI-RA compared to the CG was significant in time and group comparisons.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schwarze', 'Affiliation': 'Institut für Sportmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland. schwarze.monika@mh-hannover.de.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Fieguth', 'Affiliation': 'Institut für Sportmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Schuch', 'Affiliation': 'Rheumatologische Schwerpunktpraxis, Erlangen, Deutschland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sandner', 'Affiliation': 'Rheumatologische Schwerpunktpraxis, Erlangen, Deutschland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Edelmann', 'Affiliation': 'Rheumazentrum Bad Aibling-Erding, Bad Aibling, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Händel', 'Affiliation': 'Rheumazentrum Bad Aibling-Erding, Bad Aibling, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kettler', 'Affiliation': 'Institut für Sportmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hanke', 'Affiliation': 'Institut für Sportmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kück', 'Affiliation': 'Institut für Sportmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stein', 'Affiliation': 'Institut für Sportmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stille', 'Affiliation': 'Rheumatologie-Praxis, Hannover, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fellner', 'Affiliation': 'Rheumatologie-Praxis, Hannover, Deutschland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'De Angelis', 'Affiliation': 'Rheumatologie Centrum, Leverkusen, Deutschland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Touissant', 'Affiliation': 'Rheumatologie Centrum, Leverkusen, Deutschland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Specker', 'Affiliation': 'Klinik für Rheumatologie & Klinische Immunologie, Kliniken Essen-Mitte, Essen, Deutschland.'}]",Zeitschrift fur Rheumatologie,['10.1007/s00393-020-00871-7']
2783,32926502,The Mediterranean Diet increases GLP-1 and Oxyntomodulin compared with a Vegetarian Dietary Pattern in Patients with Type 2 Diabetes: a Randomized Controlled Cross-Over Trial.,"AIM


To compare a Mediterranean dietetic pattern with a vegetarian pattern in terms of hunger-satiety perception through post-prandial assessment of appetite-related hormones glucagon-like peptide 1 (GLP-1) and Oxyntomodulin, as well as self-rated Visual Analogue Scale (VAS) quantification, in overweight/obese subjects with type-2 diabetes (T2D).
MATERIALS AND METHODS


Twelve T2D subjects (Male to female ratio = 7:5), mean age 63 ± 8.5 years, were enrolled in a randomized, controlled, crossover study. Participants consumed a high fiber vegetarian (HFV) meal rich in complex carbohydrate as well as an isocaloric Mediterranean (MED) meal in two different visits with a one-week washout period between the two visits. Appetite ratings, glucose/insulin and gastrointestinal hormone concentrations were measured at fasting and every 30' until 210' following meal consumption.
RESULTS


GLP-1 and Oxyntomodulin levels were significantly higher following MED meal compared with HFV meal (210' area under the curve, AUC, P <0.022 and P <0.023, respectively). Both MED and HFV meal resulted in a biphasic pattern of GLP-1 and Oxyntomodulin, although MED meal was related to a delayed, significantly higher second GLP-1 peak at 150' compared with that of HFV meal (P <0.05). MED meal was related to lower glucose profile compared with HFV meal (P <0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
CONCLUSIONS


In T2D overweight/obese subjects, a MED-like meal is more effective than a vegetarian meal in terms of post-prandial plasma glucose homeostasis and GLP-1 and Oxyntomodulin release. These changes were not confirmed by VAS appetite self-assessment over a 210' period. This article is protected by copyright. All rights reserved.",2020,"MED meal was related to lower glucose profile compared with HFV meal (P <0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
","['T2D overweight/obese subjects', 'Twelve T2D subjects (Male to female ratio = 7:5), mean age 63 ± 8.5 years', 'Patients with Type 2 Diabetes', 'overweight/obese subjects with type-2 diabetes (T2D']","['high fiber vegetarian (HFV) meal rich in complex carbohydrate', 'Mediterranean Diet', 'Mediterranean dietetic pattern with a vegetarian pattern']","['second GLP-1 peak', 'GLP-1 and Oxyntomodulin levels', 'biphasic pattern of GLP-1 and Oxyntomodulin, although MED meal', 'Appetite ratings, glucose/insulin and gastrointestinal hormone concentrations', 'self-reported VAS scores and insulin trend']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556154', 'cui_str': 'Complex carbohydrate'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0086379', 'cui_str': 'Glicentin (33-69)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040833', 'cui_str': 'trends'}]",12.0,0.0209876,"MED meal was related to lower glucose profile compared with HFV meal (P <0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Mauro', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tuccinardi', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Food Science and Endocrinology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Del Toro', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Monte', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Giorgino', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rampa', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rossini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kyanvash', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Soare', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosati', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Piccoli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fioriti', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Khazrai', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Manfrini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3406']
2784,32926507,First-Line Pembrolizumab Versus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer: KEYNOTE-024 Japan Subset.,"This prespecified subanalysis of the global, randomized controlled phase 3 KEYNOTE-024 study of pembrolizumab versus chemotherapy in previously untreated metastatic non-small-cell lung cancer without EGFR/ALK alterations and a PD-L1 tumor proportion score ≥50% evaluated clinical outcomes among patients enrolled in Japan. Treatment consisted of pembrolizumab 200 mg every 3 weeks (35 cycles) or platinum-based chemotherapy (4-6 cycles). The primary endpoint was progression-free survival; secondary endpoints included overall survival and safety. Of 305 patients randomized in KEYNOTE-024 overall, 40 patients were enrolled in Japan (all received treatment: pembrolizumab, n = 21; chemotherapy, n = 19). Median progression-free survival was 41.4 (95% CI, 4.2-42.5) with pembrolizumab and 4.1 (95% CI, 2.8-8.3) months with chemotherapy (HR, 0.27 [95% CI, 0.11-0.65]; one-sided, nominal P=0.001). Median overall survival was not reached (95% CI, 22.9-NR) and 21.5 (95% CI, 5.2-35.0) months, respectively (HR, 0.39 [95% CI, 0.17-0.91]; one-sided, nominal P=0.012). Treatment-related adverse events occurred in 21/21 (100%) pembrolizumab-treated and 18/19 (95%) chemotherapy-treated patients; 8 patients (38%) and 9 patients (47%), respectively, had grade 3-5 events. Immune-mediated adverse events and infusion reactions occurred in 11 patients (52%) and 4 patients (21%), respectively; 4 patients (19%) and 1 patient (5%), respectively, had grade 3-5 events. Consistent with results from KEYNOTE-024 overall, first-line pembrolizumab improved progression-free survival and overall survival versus chemotherapy with manageable safety among Japanese patients with metastatic non-small-cell lung cancer without EGFR/ALK alterations and a PD-L1 tumor proportion score ≥50%. The trial is registered with Clinicaltrials.gov: NCT02142738.",2020,"Immune-mediated adverse events and infusion reactions occurred in 11 patients (52%) and 4 patients (21%), respectively; 4 patients (19%) and 1 patient (5%), respectively, had grade 3-5 events.","['305 patients randomized in KEYNOTE-024 overall, 40 patients were enrolled in Japan (all received treatment: pembrolizumab, n = 21; chemotherapy, n = 19', 'Metastatic Non-Small-Cell Lung Cancer', 'Japanese patients with metastatic non-small-cell lung cancer', 'previously untreated metastatic non-small-cell lung cancer without EGFR/ALK alterations and a PD-L1 tumor proportion score ≥50% evaluated clinical outcomes among patients enrolled in Japan']","['pembrolizumab versus chemotherapy', 'pembrolizumab', 'First-Line Pembrolizumab Versus Chemotherapy', 'platinum-based chemotherapy']","['overall survival and safety', 'adverse events', 'Median overall survival', 'progression-free survival', 'progression-free survival and overall survival', 'Immune-mediated adverse events and infusion reactions', 'Median progression-free survival']","[{'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4087225', 'cui_str': 'Immune-mediated adverse reaction'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}]",305.0,0.576266,"Immune-mediated adverse events and infusion reactions occurred in 11 patients (52%) and 4 patients (21%), respectively; 4 patients (19%) and 1 patient (5%), respectively, had grade 3-5 events.","[{'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Satouchi', 'Affiliation': 'Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Nosaki', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shuntougun, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University Hospital, Osaka-Sayama, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Aoe', 'Affiliation': 'Department of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center, Ube, Japan.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Akimasa', 'Initials': 'A', 'LastName': 'Sekine', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Horiike', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Umemura', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakai', 'Affiliation': 'Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Respiratory Medicine, Respiratory Center, Totanomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Katakami', 'Affiliation': 'Division of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Hida', 'Affiliation': 'Department of Thoracic Oncology, Aichi Cancer Center, Aichi, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Rong Han', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Noguchi', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ebiana', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Allergy and Respiratory Medicine, Okayama University, Okayama, Japan.'}]",Cancer science,['10.1111/cas.14647']
2785,32926603,"Acute Effects of Parent Stimulant Medication Versus Behavioral Parent Training on Mothers' ADHD, Parenting Behavior, and At-Risk Children.","BACKGROUND


Attention-deficit/hyperactivity disorder (ADHD) is present in 25%-50% of parents of children with ADHD, compromising parenting and child behavioral treatment. Efforts to treat multiplex ADHD families have not compared behavioral parenting interventions to parent psychopharmacology without confounds of other treatments. This report describes a pilot early intervention study directly comparing parent lisdexamfetamine dimesylate (LDX) to behavioral parent training (BPT) in families in which the mother had currently untreated ADHD and the young child displayed ADHD symptoms.
METHODS


Mothers with ADHD (N = 35) of 4- to 8-year-old stimulant-naive children (N = 35) were randomly assigned to an 8-week trial of LDX (starting at 20 mg/d and titrated to a maximum of 70 mg/d) or BPT. Outcomes included multi-method, multi-informant measures of (1) maternal ADHD symptoms (Conners' Adult ADHD Rating Scales) and impairment (Clinical Global Impressions-Severity of Illness scale [CGI-S] and CGI-Improvement scale [CGI-I]), (2) parenting (Alabama Parenting Questionnaire [APQ] and Dyadic Parent-Child Interaction Coding System, Fourth Edition), and (3) child ADHD symptoms (Conners Parent Rating Scale Revised-Short Form and Conners Early Childhood Scale) and impairment (CGI-S, CGI-I, and Child Impairment Rating Scale).
RESULTS


At 8 weeks, both treatments improved mothers' self-reported emotion regulation and mothers' functioning on the CGI, but only LDX improved mothers' self-reported core ADHD symptoms. LDX was associated with improvement in parents' perception of their own ADHD symptoms (Conners Inattention [P < .0001] and ADHD Index scores [P < .0001]) and their child's ADHD symptoms (P = .009). Fifty-six percent of the mothers treated with LDX (n = 10) were ""much"" or ""very much"" improved with regard to their adult ADHD based on the CGI-I scores versus 6% of mothers receiving BPT (n = 1; P = .003). BPT improved parenting on self-reported positive parenting (P = .007), inconsistent discipline (P > .0001), and corporal punishment (P = .001), while LDX improved reported inconsistent discipline (P = .001) and corporal punishment (P = .04) on the APQ, consistent with prior research. In contrast to parental LDX, which did not improve observed parenting, BPT was associated with increased positive parenting during child-directed play (P = .0002) and clean-up (P = .04) and less negative parenting (P = .04) during child-directed play. Six percent of children (n = 1) whose mothers were randomized to LDX (n = 18) were ""much"" or ""very much"" improved on the CGI-I compared to 35% (n = 16) of those treated with BPT (P = .04).
CONCLUSIONS


LDX and BPT each had unique effects on maternal ADHD symptoms and parenting, but modest effects on at-risk children. In general, LDX was more effective at treating mothers' core ADHD symptoms, but both LDX and BPT improved mothers' emotion regulation, and BPT resulted in more consistent effects on parenting measures via both maternal report and direct observation. As most children remained significantly impaired after 8 weeks of unimodal treatment, combination treatment and/or longer treatment duration may be necessary to improve functioning of multiplex ADHD families.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01816074​.",2020,"BPT improved parenting on self-reported positive parenting (P = .007), inconsistent discipline (P > .0001), and corporal punishment (P = .001), while LDX improved reported inconsistent discipline (P = .001) and corporal punishment (P = .04) on the APQ, consistent with prior research.","['N = 35) of 4- to 8-year-old stimulant-naive children (N = 35', ""Mothers' ADHD, Parenting Behavior, and At-Risk Children"", 'Mothers with ADHD', 'families in which the mother had currently untreated ADHD and the young child displayed ADHD symptoms']","['Parent Stimulant Medication Versus Behavioral Parent Training', 'BPT', 'LDX and BPT', 'lisdexamfetamine dimesylate (LDX) to behavioral parent training (BPT', 'LDX']","['positive parenting', ""multi-method, multi-informant measures of (1) maternal ADHD symptoms (Conners' Adult ADHD Rating Scales) and impairment (Clinical Global Impressions-Severity of Illness scale [CGI-S"", 'BPT improved parenting on self-reported positive parenting', 'CGI-Improvement scale [CGI-I]), (2) parenting (Alabama Parenting Questionnaire [APQ] and Dyadic Parent-Child Interaction Coding System, Fourth Edition), and (3) child ADHD symptoms (Conners Parent Rating Scale Revised-Short Form and Conners Early Childhood Scale) and impairment (CGI-S, CGI-I, and Child Impairment Rating Scale', ""mothers' self-reported emotion regulation and mothers' functioning"", 'corporal punishment', ""mothers' self-reported core ADHD symptoms"", 'ADHD Index scores', ""parents' perception of their own ADHD symptoms (Conners Inattention"", 'negative parenting', ""child's ADHD symptoms"", 'maternal ADHD symptoms and parenting']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1739826', 'cui_str': 'Lisdexamfetamine dimesylate'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",35.0,0.044308,"BPT improved parenting on self-reported positive parenting (P = .007), inconsistent discipline (P > .0001), and corporal punishment (P = .001), while LDX improved reported inconsistent discipline (P = .001) and corporal punishment (P = .04) on the APQ, consistent with prior research.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chronis-Tuscano', 'Affiliation': 'Department of Psychology, University of Maryland College Park, College Park, Maryland, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'French', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Strickland', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Sasser', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Erin N Schoenfelder', 'Initials': 'ENS', 'LastName': 'Gonzalez', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Whitlock', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Stein', 'Affiliation': ""Department of Psychiatry and Behavioral Medicine, Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA 98105. Mstein42@uw.edu.""}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13173']
2786,32926604,"Efficacy and Safety of Dasotraline in Adults With Binge-Eating Disorder: A Randomized, Placebo-Controlled, Flexible-Dose Clinical Trial.","OBJECTIVE


Binge-eating disorder (BED) is the most prevalent eating disorder; however, few evidence-based treatments are available. The aim of this study was to evaluate the efficacy and safety of dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, in adults with BED.
METHODS


Patients with a DSM-5 diagnosis of BED (intent-to-treat sample, N = 315) were randomized to 12 weeks of double-blind treatment with once-daily, flexible doses (4, 6, or 8 mg/d) of dasotraline or placebo. Primary endpoint was change in diary-based assessment of number of binge-eating days per week at week 12. Key secondary endpoints included changes from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) and Yale-Brown Obsessive Compulsive Scale Modified for Binge-Eating (YBOCS-BE) and percentage of subjects with cessation of binge eating in the final 4 weeks.
RESULTS


Treatment with dasotraline was associated with a significantly greater reduction in binge-eating days per week at study endpoint (vs placebo; least squares mean [SE] difference score, -0.99 [0.17]; P < .0001; effect size [ES], 0.74). Significant endpoint improvement was observed for the 3 key secondary measures, CGI-S (P < .0001; ES, 0.95), YBOCS-BE (P < .0001; ES, 0.96), and 4-week cessation of binge eating (46.5% vs 20.6%; P < .0001). The most common adverse events in the dasotraline vs placebo groups were insomnia (44.6% vs 8.1%), dry mouth (27.4% vs 5.0%), decreased appetite (19.7% vs 6.9%), and anxiety (17.8% vs 2.5%). Discontinuation due to adverse events occurred in 11.3% of patients on dasotraline vs 2.5% on placebo.
CONCLUSIONS


The results of this placebo-controlled, double-blind study found dasotraline to be an efficacious, safe, and generally well-tolerated treatment for BED.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02564588.",2020,"Significant endpoint improvement was observed for the 3 key secondary measures, CGI-S (P < .0001; ES, 0.95), YBOCS-BE (P < .0001; ES, 0.96), and 4-week cessation of binge eating (46.5% vs 20.6%; P < .0001).","['adults with BED', 'Adults With Binge-Eating Disorder', 'Patients with a DSM-5 diagnosis of BED (intent-to-treat sample, N = 315']","['dasotraline or placebo', 'Dasotraline', 'placebo', 'dasotraline', 'Placebo']","['change in diary-based assessment of number of binge-eating days', 'dry mouth', 'efficacy and safety', 'YBOCS-BE', 'binge-eating days', 'Efficacy and Safety', '4-week cessation of binge eating', 'adverse events', 'insomnia', 'Clinical Global Impressions-Severity of Illness scale (CGI-S) and Yale-Brown Obsessive Compulsive Scale Modified for Binge-Eating (YBOCS-BE) and percentage of subjects with cessation of binge eating', 'CGI-S', 'decreased appetite', 'anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C4276542', 'cui_str': '4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",315.0,0.688368,"Significant endpoint improvement was observed for the 3 key secondary measures, CGI-S (P < .0001; ES, 0.95), YBOCS-BE (P < .0001; ES, 0.96), and 4-week cessation of binge eating (46.5% vs 20.6%; P < .0001).","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, Ohio, USA.'}, {'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Hudson', 'Affiliation': 'Biological Psychiatry Laboratory, McLean Hospital, Belmont, Massachusetts; and Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Anna I', 'Initials': 'AI', 'LastName': 'Guerdjikova', 'Affiliation': 'Lindner Center of HOPE, Mason, Ohio, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.'}, {'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Koblan', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldman', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Dr, Marlborough, MA 01752. bradford.navia@sunovion.com.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13068']
2787,32926748,Irsogladine maleate alters expression of a tight junction protein in portal hypertensive gastropathy.,"BACKGROUND AND AIM


Portal hypertensive gastropathy (PHG) is characterized by noninflammatory edema and vasodilatation of the lamina propria of the mucosal epithelium. In addition, the alterations of intercellular junction proteins and dilatation of the endothelial gaps have been reported. In this study, we examined whether irsogladine maleate (IM), a gastric mucosal protective agent, has the potential to improve PHG by restoration of tight junctions (TJs).
METHODS


Twenty-four patients with PHG were registered and randomly assigned into 2 groups: 12 patients in the IM-administration group and 12 patients in the non-administration group. In the administration group, IM (4 mg/day) was administered orally for 12 weeks. Gastric mucosa with a red color in patients with PHG were obtained endoscopically on the registration day and 12 weeks later. The endoscopic findings were evaluated, an immunohistochemical analysis of claudin-3 (a TJ protein) expression in gastric mucosal tissues by a laser microscope was performed, and claudin-3 expression was quantified by western blot analysis.
RESULTS


IM improved the degree of PHG in 2/12 patients endoscopically, in contrast to none of the 12 patients in the non-administration group. Immunohistochemical analysis showed that expression of claudin-3 increased in 8/12 patients in the IM-administration group, and 2/12 patients in the non-administration group (p=0.036). Western blot analysis revealed that the increase in claudin-3 after 12 weeks was significantly higher in the IM-administration group than in the non-administration group (p=0.010).
CONCLUSIONS


The present pilot study suggested that IM might improve the gastric mucosa in PHG through restoration of TJ-protein claudin-3.",2020,"Immunohistochemical analysis showed that expression of claudin-3 increased in 8/12 patients in the IM-administration group, and 2/12 patients in the non-administration group (p=0.036).","['Gastric mucosa with a red color in patients with PHG', 'portal hypertensive gastropathy', 'Twenty-four patients with PHG']","['Irsogladine maleate', 'irsogladine maleate (IM']","['claudin-3', 'expression of claudin-3', 'degree of PHG']","[{'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580174', 'cui_str': 'Portal hypertensive gastropathy'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0091573', 'cui_str': 'irsogladine maleate'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0580174', 'cui_str': 'Portal hypertensive gastropathy'}]",24.0,0.0230502,"Immunohistochemical analysis showed that expression of claudin-3 increased in 8/12 patients in the IM-administration group, and 2/12 patients in the non-administration group (p=0.036).","[{'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Irie', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Nishijin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Naoaki', 'Initials': 'N', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyayama', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Umeda', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Takata', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Shinjiro', 'Initials': 'S', 'LastName': 'Inomata', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Morihara', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Takeyama', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shakado', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Sakisaka', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15259']
2788,32927269,The effect of remote patient monitoring on the primary care clinic visit frequency among adults with type 2 diabetes.,"AIMS


Healthcare organizations are increasingly using technology to assist in diabetes management based on telemedicine's proven ability to improve glycemic regulation, decrease cost, and overcome barriers to effective healthcare. Nevertheless, it remains unclear how telemedicine intersects with primary care. We aim to measure the impact of a remote monitoring program for diabetes on primary care delivery through analysis of primary care office visit frequency.
METHODS


Patients eligible to participate in our institution's remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care""). The number of scheduled and completed primary care office visits in the 12 months prior to and after the index date were measured for both groups. The index date was the enrollment date or, for the patients who received usual care, the next available enrollment session after eligibility screen. Two-sample t-tests were used to examine the change in frequency of office visits prior to and after enrollment for participants, as well as the difference in visit frequency between enrolled patients versus patients receiving usual care.
RESULTS


There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth. Furthermore, there was no difference in the number of scheduled or completed primary care visits between patients enrolled in telehealth versus those receiving usual care.
CONCLUSION


Participation in telehealth has been shown to be associated with significant HbA1c reductions in prior work, yet our data suggest that remote monitoring is not associated with a change in primary care office visit frequency. This suggests that telehealth may improve diabetes management independently of primary care visits.",2020,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"['adults with type 2 diabetes', 'Patients eligible to participate in our institution\'s remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care']","['remote monitoring program', 'remote patient monitoring']",['number of scheduled or completed primary care clinic visits'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0422587', 'cui_str': 'Diabetes monitoring check done'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]",,0.0160126,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"[{'ForeName': 'Morgan Hampton', 'Initials': 'MH', 'LastName': 'Randall', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary Merle', 'Initials': 'ZM', 'LastName': 'Haulsee', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William Patrick', 'Initials': 'WP', 'LastName': 'Moran', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth Barnhardt', 'Initials': 'EB', 'LastName': 'Kirkland', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kirklane@musc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104267']
2789,32927285,"Open-label titration of apomorphine sublingual film in patients with Parkinson's disease and ""OFF"" episodes.","INTRODUCTION


The efficacy and safety of apomorphine sublingual film (APL-130277; APL) for the on-demand treatment of ""OFF"" episodes associated with Parkinson's disease (PD) was demonstrated in a double-blind trial. Herein we describe the ability of patients to receive effective and tolerable APL dose titration during the open-label titration phase.
METHODS


Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled. In practically defined ""OFF,"" patients were observed for a FULL ""ON"" after their usual morning carbidopa/levodopa (CD/LD) dose and then after titration with APL following each increasing dose (10-35 mg). Antiemetic medication was administered for 3 days before initiation of titration and was continued throughout titration. Motor responses were evaluated predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Safety outcomes were evaluated.
RESULTS


Among 141 patients who enrolled in the study and received APL during open-label titration, 109 (77.3%) achieved a FULL ""ON"" (66.1% at 10-20 mg) and 10 did not. Patients who successfully completed APL dose titration tended to be younger, had a longer mean time since PD diagnosis, and had lower levodopa requirements than those who discontinued during titration for any reason. Change in MDS-UPDRS Part III scores from predose to 30 min postdose after titration with the effective dose of APL (n = 109) was similar across all dose groups. In a post hoc analysis, the magnitude of motor response with APL was ~2-fold higher than with CD/LD 15 min postdose, and the observed peak response occurred earlier with APL than with the trend seen for CD/LD (45 vs 90 min, respectively). Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%). Twelve patients discontinued due to TEAEs during APL dose titration, most commonly (≥2%) because of dizziness (2.8%), nausea (2.1%), and somnolence (2.1%).
CONCLUSION


Among eligible patients with PD and ""OFF"" episodes who had their APL dose successfully titrated to an effective and tolerable level, most were able to do so within the first 3 titrated doses but some required further dose escalations. The use of APL can provide benefit for the treatment of ""OFF"" episodes.",2020,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","['patients with Parkinson\'s disease and ""OFF"" episodes', '141 patients who enrolled in the study and received', 'OFF"" episodes associated with Parkinson\'s disease (PD', 'eligible patients with PD and ""OFF"" episodes who had their', 'Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled']","['apomorphine sublingual film', 'APL', 'apomorphine sublingual film (APL-130277; APL', 'FULL ""ON']","['peak response', ""predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'Change in MDS-UPDRS Part III scores', 'nausea', 'magnitude of motor response with APL', 'longer mean time since PD diagnosis', 'somnolence', 'dizziness', 'levodopa requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]",141.0,0.03312,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Hui', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, United States. Electronic address: Jennifer.hui@med.usc.edu.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Fox', 'Affiliation': 'University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada; Division of Neurology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Neeson', 'Affiliation': 'Sunovion Pharmaceuticals Canada Inc., Mississauga, Ontario, Canada.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pappert', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.08.028']
2790,32927324,Enhanced Recovery after Surgery in Elderly Gastric Cancer Patients Undergoing Laparoscopic Total Gastrectomy.,"BACKGROUND


The aim of this study was to evaluate the effects of the enhanced recovery after surgery (ERAS) program versus conventional perioperative care on the short-term postoperative outcomes among elderly patients with gastric cancer who are undergoing laparoscopic total gastrectomy.
METHODS


Elderly patients with gastric cancer (age ≥ 65 y) who are undergoing laparoscopic total gastrectomy were randomized to ERAS or conventional perioperative care groups. Short-term postoperative outcomes, including postoperative hospital stay, mortality, complications, readmission rate, and reoperation rate were compared between the two groups. In addition, blood samples were taken preoperatively (baseline) and on postoperative days 1, 3, and 5. Systemic human leukocyte antigen (HLA)-DR expression on monocytes and C-reactive protein (CRP) were analyzed.
RESULTS


Of the 171 eligible patients, 85 patients were assigned to receive ERAS program treatment (ERAS group) and 86 patients to receive conventional care (conventional group). The patients' characteristics were comparable. Postoperative hospital stay was shorter in the ERAS group than in the conventional group (11 [7-11] versus 13 [8-20] d, P < 0.001). Hospital mortality, overall morbidity, morbidity ≥ Clavien-Dindo (C-D) grade II, readmission rate, and reoperation rate did not show significant differences between the two groups. However, morbidity ≥ C-D grade IIIa was lower in the ERAS group than that in the conventional group (8.2% versus 18.6%, P = 0.047). The ERAS program shortened the number of days to postoperative first flatus, first defecation, semifluid diet, and soft bland diet. Moreover, the ERAS program increased the HLA-DR expression on monocytes and decreased the CRP levels on postoperative days 1, 3, and 5.
CONCLUSIONS


The ERAS program was feasible and effective for elderly patients with gastric cancer who are undergoing laparoscopic total gastrectomy. The benefits of ERAS were associated with improvement of impaired immune function and suppression of inflammatory reaction.",2020,"Moreover, the ERAS program increased the HLA-DR expression on monocytes and decreased the CRP levels on postoperative days 1, 3, and 5.
","['171 eligible patients, 85 patients', '65 y) who are undergoing laparoscopic total gastrectomy', 'Elderly Gastric Cancer Patients Undergoing Laparoscopic Total Gastrectomy', 'Elderly patients with gastric cancer (age\xa0≥', 'elderly patients with gastric cancer who are undergoing laparoscopic total gastrectomy']","['ERAS', 'Systemic human leukocyte antigen ', 'ERAS program', 'surgery (ERAS) program versus conventional perioperative care', 'ERAS program treatment (ERAS', 'conventional care (conventional group']","['CRP levels', 'impaired immune function and suppression of inflammatory reaction', 'HLA-DR expression on monocytes', 'HLA)-DR expression on monocytes and C-reactive protein (CRP', 'Postoperative hospital stay', 'postoperative hospital stay, mortality, complications, readmission rate, and reoperation rate', 'Hospital mortality, overall morbidity, morbidity\xa0≥\xa0Clavien-Dindo (C-D) grade II, readmission rate, and reoperation rate', 'number of days to postoperative first flatus, first defecation, semifluid diet, and soft bland diet', 'morbidity\xa0≥\xa0C-D grade IIIa']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR antigen'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0301572', 'cui_str': 'Bland diet'}]",171.0,0.022227,"Moreover, the ERAS program increased the HLA-DR expression on monocytes and decreased the CRP levels on postoperative days 1, 3, and 5.
","[{'ForeName': 'Shougen', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Taohua', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Liver Disease Center, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Dongying People's Hospital, Shandong, China.""}, {'ForeName': 'Zhaojian', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China. Electronic address: yanbingzhou999@hotmail.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.07.037']
2791,32927371,Neural affective mechanisms associated with treatment responsiveness in veterans with PTSD and comorbid alcohol use disorder.,"Post-traumatic stress disorder (PTSD) is associated with neuro-physiological abnormalities reflecting increased anticipatory anxiety and reactivity to traumatic cues. It remains unclear whether neural mechanisms associated with PTSD treatment responsiveness, i.e. hyperactivation of the affective salience network in the brain, extend to a comorbid PTSD and substance use disorder population. Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD) were randomly assigned to either prolonged exposure or a non-exposure based treatment. They completed an affective anticipation task while undergoing fMRI, immediately prior and after completing treatment. After controlling for type and length of treatment, larger reduction of PTSD symptoms was associated with decreased anticipatory activation to negative trauma-related cues in the right pre-Supplementary Motor Area (pre-SMA), a region associated with emotion regulation. Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region. Our findings suggest that post-treatment reductions in anticipatory reactivity to trauma-related cues in the pre-SMA and para-hippocampal area are associated with larger PTSD symptom reduction in individuals with co-occurring PTSD and AUD. These results may offer neurofeedback training targets as an alternative to or enhancement of other PTSD treatment modalities in this population.",2020,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","['veterans with PTSD and comorbid alcohol use disorder', 'Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD', 'Post-traumatic stress disorder (PTSD']",['prolonged exposure or a non-exposure based treatment'],"['PTSD symptoms', 'PTSD severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",31.0,0.00943451,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","[{'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Harlé', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States. Electronic address: kharle@ucsd.edu.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Simmons', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Spadoni', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111172']
2792,32927858,Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial.,"Chronic neck pain is one of today's most prevalent pathologies. The International Classification of Diseases categorizes four subgroups based on patients' associated symptoms. However, this classification does not encompass upper cervical spine dysfunction. The aim is to compare the short- and mid-term effectiveness of adding a manual therapy approach to a cervical exercise protocol in patients with chronic neck pain and upper cervical spine dysfunction. Fifty-eight subjects with chronic neck pain and upper cervical spine dysfunction were recruited (29 = Manual therapy + Exercise; 29 = Exercise). Each group received four 20-min sessions, one per week during four consecutive weeks, and a home exercise regime. Upper flexion and flexion-rotation test range of motion, neck disability index, craniocervical flexion test, visual analogue scale, pressure pain threshold, global rating of change scale, and adherence to self-treatment were assessed at the beginning, end of the intervention and at 3- and 6-month follow-ups. The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group. Four 20-min sessions of Manual therapy + Exercise along with a home-exercise program is more effective in the short- to mid-term than an exercise protocol and a home-exercise program for patients with chronic neck pain and upper cervical dysfunction.",2020,The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group.,"['patients with chronic neck pain and upper cervical dysfunction', 'patients with chronic neck pain and upper cervical spine dysfunction', 'Patients with Chronic Neck Pain in Short- and Mid-Term', 'Fifty-eight subjects with chronic neck pain and upper cervical spine dysfunction were recruited (29 = Manual therapy + Exercise; 29 = Exercise']","['cervical exercise protocol', 'Cervical Exercise Program', 'exercise protocol and a home-exercise program', 'Manual therapy + Exercise', 'Manual therapy + Exercise along with a home-exercise program', 'manual therapy approach']","['Chronic neck pain', 'Upper flexion and flexion-rotation test range of motion, neck disability index, craniocervical flexion test, visual analogue scale, pressure pain threshold, global rating of change scale, and adherence to self-treatment', 'short- and medium-term']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",58.0,0.044157,The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group.,"[{'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Malo-Urriés', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-de-Toro', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-de-Celis', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Spain.'}, {'ForeName': 'María Orosia', 'Initials': 'MO', 'LastName': 'Lucha-López', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Tricás-Moreno', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Lorente', 'Affiliation': 'Impact Laboratory, Aragón Institute of Engineering Research (I3A), Universidad de Zaragoza, 50018 Zaragoza, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo-García', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186601']
2793,32927895,Eating Fast Has a Significant Impact on Glycemic Excursion in Healthy Women: Randomized Controlled Cross-Over Trial.,"Epidemiological studies have shown that self-reported fast eating increases the risk of diabetes and obesity. Our aim was to evaluate the acute effect of fast eating on glycemic parameters through conducting a randomized controlled cross-over study with young healthy women. Nineteen healthy women wore a flash glucose monitoring system for 6 days. Each participant consumed identical test meals with a different eating speed of fast eating (10 min) or slow eating (20 min) on the 4th or the 5th day. The daily glycemic parameters were compared between the 2 days. The mean amplitude of glycemic excursion (MAGE; fast eating 3.67 ± 0.31 vs. slow eating 2.67 ± 0.20 mmol/L,  p  < 0.01), incremental glucose peak (IGP; breakfast 2.30 ± 0.19 vs. 1.71 ± 0.12 mmol/L,  p  < 0.01, lunch 4.06 ± 0.33 vs. 3.13 ± 0.28 mmol/L,  p  < 0.01, dinner 3.87 ± 0.38 vs. 2.27 ± 0.27 mmol/L,  p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  p  < 0.001) for fast eating were all significantly higher than those for slow eating. The results suggest that fast eating is associated with higher glycemic excursion in healthy women.",2020,"p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  ","['Nineteen healthy women wore a', 'healthy women', 'Healthy Women', 'young healthy women']","['identical test meals with a different eating speed of fast eating (10 min) or slow eating', 'flash glucose monitoring system']","['glycemic excursion', 'daily glycemic parameters', 'fast eating', 'Glycemic Excursion', 'incremental glucose peak', 'mean amplitude of glycemic excursion']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",19.0,0.0534393,"p  < 0.001), and incremental area under the curve for glucose of dinner 2 h (IAUC; 256 ± 30 vs. 128 ± 18 mmol/L × min,  ","[{'ForeName': 'Yuuki', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Shizuo', 'Initials': 'S', 'LastName': 'Kajiyama', 'Affiliation': 'Kajiyama Clinic, Kyoto Gojyo Clinic Build. 20-1, Higasionnmaeda-cho, Nishinanajyo, Shimogyo-ku, Kyoto 600-8898, Japan.'}, {'ForeName': 'Ayasa', 'Initials': 'A', 'LastName': 'Nitta', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyawaki', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}, {'ForeName': 'Neiko', 'Initials': 'N', 'LastName': 'Ozasa', 'Affiliation': 'Graduate School of Medicine, Kyoto University, 54, Kawahara-cho, Syogoin, Sakyo-ku, Kyoto 606-8507, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Kajiyama', 'Affiliation': 'Japanese Red Cross Kyoto Daini Hospital, 355-5, Kamanza, Marutamachi, Kamigyo-ku, Kyoto 602-8026, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Imai', 'Affiliation': ""Department of Food and Nutrition, Faculty of Home Economics, Kyoto Women's University, 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto 605-8501, Japan.""}]",Nutrients,['10.3390/nu12092767']
2794,32928014,A double-blind placebo controlled trial on effectiveness of prophylactic dexamethasone for preventing post- dural puncture headache after spinal anesthesia for cesarean section.,"AIM


To determine the effect of dexamethasone in reducing post-dural puncture headache (PDPH) after spinal anesthesia for cesarean section (CS).
METHODS


A double blind placebo controlled randomized trial of parturients undergoing CS under spinal anesthesia was conducted. Participants ( n  = 192) were randomly (1:1 ratio) given either 2mls (8 mg) of dexamethasone ( n  = 96) intravenously or 2mls of normal saline ( n  = 96) intravenously as placebo after clamping the umbilical cord. Visual analogue scale was used to assess the incidence and severity of PDPH on the first and fourth post-operative days. The primary outcome measure was incidence of PDPH while the secondary outcome measure was incidence of nausea and vomiting. Analysis was by intention-to-treat.
RESULTS


Baseline socio-demographic and clinical variables were similar between the two groups and none of the women was lost to follow up. The incidence of PDPH (8.3% vs 25.0%;  p  = .002) and nausea (11.5% vs 25.0%;  p  = .015) were significantly lower in dexamethasone group. The severity of headache in the control groups were statistically higher on the first ( p  < .001) and fourth ( p  < .001) post-operative days. .
CONCLUSION


Prophylactic dexamethasone reduces the incidence and severity of PDPH on both the first and fourth post-operative day after spinal anesthesia for CS. There was also an improvement on the incidence of nausea on the dexamethasone group compared to control.",2020,"The severity of headache in the control groups were statistically higher on the first ( p  < .001) and fourth ( p  < .001) post-operative days. .
","['Participants ( n \u2009=\u2009192', 'post-dural puncture headache (PDPH) after spinal anesthesia for cesarean section (CS', 'parturients undergoing CS under spinal anesthesia', 'post- dural puncture headache after spinal anesthesia for cesarean section']","['dexamethasone ( n \u2009=\u200996) intravenously or 2mls of normal saline ( n \u2009=\u200996) intravenously as placebo', 'dexamethasone', 'placebo', 'Prophylactic dexamethasone', 'prophylactic dexamethasone']","['nausea and vomiting', 'severity of headache', 'nausea', 'incidence of PDPH', 'incidence of nausea', 'Visual analogue scale', 'incidence and severity of PDPH']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0270697', 'cui_str': 'Headache following lumbar puncture'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",192.0,0.554228,"The severity of headache in the control groups were statistically higher on the first ( p  < .001) and fourth ( p  < .001) post-operative days. .
","[{'ForeName': 'Boniface Chukwuneme', 'Initials': 'BC', 'LastName': 'Okpala', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria.'}, {'ForeName': 'George Uchenna', 'Initials': 'GU', 'LastName': 'Eleje', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria.'}, {'ForeName': 'Joseph Ifeanyichukwu', 'Initials': 'JI', 'LastName': 'Ikechebelu', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria.'}, {'ForeName': 'Chukwuemeka Jude', 'Initials': 'CJ', 'LastName': 'Ofojebe', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria.'}, {'ForeName': 'Toochukwu Benjamin', 'Initials': 'TB', 'LastName': 'Ejikeme', 'Affiliation': 'Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'Cyril Emeka', 'Initials': 'CE', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Anesthesiology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'Augusta Nkiruka', 'Initials': 'AN', 'LastName': 'Okpala', 'Affiliation': 'Department of Family Medicine, Federal Medical Centre, Owerri, Nigeria.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1818719']
2795,32928020,Prophylactic intraoperative uterine artery embolization for the management of major placenta previa.,"PURPOSE


Placenta previa is a major cause of maternal morbidity and mortality, associated to a high risk of peripartum hemorrhage and hysterectomy. We aimed to verify if prophylactic intraoperative uterine artery embolization in patients with placenta previa and at least one additional risk of bleeding (major placenta previa), can reduce hemorrhage, need for blood transfusions, peripartum hysterectomy and maternal morbidity.
MATERIALS AND METHODS


We enrolled 76 patients with major placenta previa; a specific multidisciplinary protocol was designed for management, including ultrasound evaluation, hospitalization at 34 weeks, antenatal corticosteroids and scheduled cesarean section at 35-36 weeks. 44 patients (control group or CTR) were treated with elective cesarean section, 32 patients (embolized group or EMB) underwent selective catheterization of bilateral uterine arteries before cesarean section and subsequent uterine embolization. In both cases cesarean section was performed by a senior surgeon.
RESULTS


Significant differences were found in term of intraoperative blood loss (CTR: 1431 ml; EMB: 693 ml); despite an high percentage of CTR patients had a bleeding greater than 1000 ml (56%), the need for blood transfusion was not significantly different between the two groups. Time of surgery was higher in the EMB group, considering that embolization procedure required approximatively 30 min. Three patients from the CTR group needed hysterectomy and ICU admission, compared to none in the EMB group. Duration of hospitalization and neonatal outcome were similar. Uterine embolization was not related to any short or long-term complications; return to normal menses and preservation of fertility were confirmed at follow up.
CONCLUSIONS


Our results are promising, although we believe that a major contribution is referable to the multidisciplinary approach rather than the procedure itself. Nevertheless, we demonstrated the feasibility and safety of preventive uterine embolization in patients with placenta previa; in order to establish its prophylactic role in the prevention of peripartum hemorrhage, randomized trial should be carried out, on a larger population.",2020,"Uterine embolization was not related to any short or long-term complications; return to normal menses and preservation of fertility were confirmed at follow up.
","['patients with placenta previa and at least one additional risk of bleeding (major placenta previa', 'We enrolled 76 patients with major placenta previa', '44 patients ', 'patients with placenta previa', 'major placenta previa']","['selective catheterization of bilateral uterine arteries before cesarean section and subsequent uterine embolization', 'Prophylactic intraoperative uterine artery embolization', 'control group or CTR', 'preventive uterine embolization', 'antenatal corticosteroids and scheduled cesarean section', 'prophylactic intraoperative uterine artery embolization', 'elective cesarean section, 32 patients (embolized group or EMB']","['Time of surgery', 'intraoperative blood loss', 'Duration of hospitalization and neonatal outcome', 'feasibility and safety', 'Uterine embolization', 'hysterectomy and ICU admission', 'need for blood transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032046', 'cui_str': 'Placenta previa'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",76.0,0.120082,"Uterine embolization was not related to any short or long-term complications; return to normal menses and preservation of fertility were confirmed at follow up.
","[{'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Radaelli', 'Affiliation': ""Department of Obstetrics and Gynecology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Ferrari', 'Affiliation': ""Department of Obstetrics and Gynecology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Silvia F', 'Initials': 'SF', 'LastName': 'Duiella', 'Affiliation': ""Department of Obstetrics and Gynecology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Federica G', 'Initials': 'FG', 'LastName': 'Gazzola', 'Affiliation': ""Department of Obstetrics and Gynecology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Campoleoni', 'Affiliation': ""Department of Medical Physics, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Merlini', 'Affiliation': ""Department of Anesthesiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martinetti', 'Affiliation': ""Department of Radiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Ambrosini', 'Affiliation': ""Department of Anesthesiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Manuela W', 'Initials': 'MW', 'LastName': 'Ossola', 'Affiliation': ""Department of Obstetrics and Gynecology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolini', 'Affiliation': ""Department of Radiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1818218']
2796,32937627,"Pharmacokinetics and Safety of Intravenous, Intravesical, Rectal, Transdermal, and Vaginal Melatonin in Healthy Female Volunteers: A Cross-Over Study.","INTRODUCTION


We aimed to investigate the pharmacokinetic properties and safety of melatonin administered by alternative routes of administration.
METHODS


This study employed a cross-over design in healthy female volunteers. Twenty-five milligrams of melatonin was administered intravenously, intravesically, rectally, transdermally, and vaginally. Blood samples were collected at specified time points up to 24 h following intravenous, intravesical, rectal, and vaginal administration, and up to 48 h following transdermal administration. Plasma melatonin concentrations were determined by radioimmunoassay. Sedation was evaluated by a simple reaction-time test, and sleepiness was assessed by the Karolinska Sleepiness Scale. Adverse events were registered for each route of administration.
RESULTS


Ten participants were included. We documented a mean (SD) time to maximal concentration of 51 (29) min for intravesical, 24 (20) min for rectal, 21 (8) h for transdermal, and 147 (56) min for vaginal administration. The mean (SD) elimination half-life was 47 (6) min for intravenous, 58 (7) min for intravesical, 60 (18) min for rectal, 14.6 (11.1) h for transdermal, and 129 (17) min for vaginal administration. The mean (SD) bioavailability was 3.6 (1.9)% for intravesical, 36.0 (28.6)% for rectal, 10.0 (5.7)% for transdermal, and 97.8 (31.7)% for vaginal administration. No significant changes in reaction times were observed following administration of melatonin by any of the administration routes. Increased tiredness was documented following transdermal administration only. No serious adverse effects were documented.
CONCLUSION


Rectally and vaginally administered melatonin may serve as relevant alternatives to standard oral melatonin therapy. Transdermal delivery of melatonin displayed an extended absorption and can be applied if prolonged effects are intended. Intravesical administration displayed, as expected, a very limited bioavailability. Melatonin administered by these routes of administration was safe.",2020,"No serious adverse effects were documented.
","['Healthy Female Volunteers', 'healthy female volunteers', 'Ten participants were included']","['melatonin', 'Melatonin', 'Intravenous, Intravesical, Rectal, Transdermal, and Vaginal Melatonin']","['simple reaction-time test, and sleepiness', 'Increased tiredness', 'Adverse events', 'serious adverse effects', 'mean (SD) elimination half-life', 'reaction times', 'Plasma melatonin concentrations', 'mean (SD) time to maximal concentration', 'mean (SD) bioavailability', 'Karolinska Sleepiness Scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",10.0,0.15228,"No serious adverse effects were documented.
","[{'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Zetner', 'Affiliation': 'Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark, dennis.zetner@gmail.com.'}, {'ForeName': 'Lars Peter Kloster', 'Initials': 'LPK', 'LastName': 'Andersen', 'Affiliation': 'Department of Anesthesiology Z, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Alder', 'Affiliation': 'Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Majken Lyhne', 'Initials': 'ML', 'LastName': 'Jessen', 'Affiliation': 'Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Tolstrup', 'Affiliation': 'Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Pharmacology,['10.1159/000510252']
2797,32937634,Uterine Isthmus Tourniquet during Abdominal Myomectomy: Support or Hazard? A Randomized Double-Blind Trial.,"BACKGROUND AND OBJECTIVES


A tourniquet has been suggested as a useful means of reducing massive hemorrhage during myomectomy. However, it is not clear whether the restricted perfusion affects the ovaries. In the present study, we examined the effect of a tourniquet on ovarian reserve and blood loss during myomectomy.
MATERIALS AND METHODS


In a randomized double-blind clinical trial, fertile nonobese patients scheduled for abdominal myomectomy at Rasool-e-Akram Hospital from February 2018 to June 2019 were randomized to a tourniquet (n = 46) or a non-tourniquet group (n = 35). Serum levels of anti-Müllerian hormone (AMH) and follicle-stimulating hormone (FSH) were measured before and 3 months after surgery, blood loss was recorded during surgery, and serum levels of hemoglobin (Hb) were recorded before surgery, 6 h and 3 days after surgery. SPSS version 21 was used for statistical analysis.
RESULTS


Demographic, obstetric, and myoma characteristics were similar in the 2 groups (p > 0.05). The mean baseline values of AMH and FSH did not differ between groups (p > 0.05). After surgery, only FSH was higher in the control group (p = 0.043). Despite the time taken to fasten and open the tourniquet, the mean operating time was shorter in the tourniquet group (p < 0.001). Blood loss was higher in the control group (p = 0.005). The drop in Hb levels at 6 h after surgery was higher in the non-tourniquet group (p = 0.002). Blood loss was significantly associated with the duration of surgery (r = 0.523, p < 0.001).
CONCLUSION


The use of a tourniquet during abdominal myomectomy significantly reduced the mean volume of blood loss compared to the non-tourniquet group, while it did not prolong the duration of surgery, nor reduced the ovarian reserve. A tourniquet is a safe and efficient measure during abdominal myomectomy.",2020,Blood loss was higher in the control group (p = 0.005).,['fertile nonobese patients scheduled for abdominal myomectomy at Rasool-e-Akram Hospital from February 2018 to June 2019'],['tourniquet (n = 46) or a non-tourniquet group'],"['mean operating time', 'ovarian reserve', 'Serum levels of anti-Müllerian hormone (AMH) and follicle-stimulating hormone (FSH', 'drop in Hb levels', 'Demographic, obstetric, and myoma characteristics', 'mean volume of blood loss', 'serum levels of hemoglobin (Hb', 'Blood loss', 'mean baseline values of AMH and FSH', 'blood loss', 'ovarian reserve and blood loss', 'FSH']","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.332048,Blood loss was higher in the control group (p = 0.005).,"[{'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Mehdizadehkashi', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Tahermanesh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Astaraei', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Najmi', 'Affiliation': 'Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Rakhshande', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Ahmadi Pishkuhi', 'Affiliation': 'Pars Advanced and Minimally Invasive Medical Manners Research Center, Pars Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Campus Kiel, Kiel School of Gynaecological Endoscopy, University Hospitals Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Chaichian', 'Affiliation': 'Pars Advanced and Minimally Invasive Medical Manners Research Center, Pars Hospital, Iran University of Medical Sciences, Tehran, Iran, shchaichian@gmail.com.'}]",Gynecologic and obstetric investigation,['10.1159/000510512']
2798,32937839,Effects of Smoking and Smoking Cessation on the Intestinal Microbiota.,"We evaluated associations of smoking heaviness markers and the effects of smoking cessation on the intestinal microbiota and cardiovascular disease risk factors in current smokers undertaking a quit attempt. Participants were current smokers enrolled in a prospective randomized clinical trial of smoking cessation therapies with visits at baseline, 2, and 12 weeks. Genomic DNA was extracted from fecal samples followed by 16S rRNA gene sequencing and analysis using the QIIME2 software workflow. Relative abundances of bacterial taxa and alpha- and beta-diversity measures were used for comparisons. The 36 smokers were (mean (standard deviation)) 51.5 (11.1) years old (42% male) and smoked 15.1 (6.4) cigarettes per day for 22.7 (11.9) pack-years. Relative abundances of the phylum Actinobacteria correlated with pack-years (rho = -0.44,  p  = 0.008) and Cyanobacteria correlated with CO levels (rho = 0.39,  p  = 0.021). After 12 weeks, relative abundances of the phylum Bacteroidetes increased ( p ANCOVA  = 0.048) and Firmicutes decreased ( p ANCOVA  = 0.036) among abstainers compared to continuing smokers. Increases in alpha-diversity were associated with heart rates (rho = -0.59,  p  = 0.037), systolic blood pressures (rho = -0.58,  p  = 0.043), and C-reactive protein (rho = -0.60,  p  = 0.034). Smoking cessation led to minor changes in the intestinal microbiota. It is unclear if the proven health benefits of smoking cessation lead to salutary changes in the intestinal microbiota.",2020,"After 12 weeks, relative abundances of the phylum Bacteroidetes increased ( p ANCOVA  = 0.048) and Firmicutes decreased ( p ANCOVA  = 0.036) among abstainers compared to continuing smokers.","['51.5 (11.1) years old (42% male) and smoked 15.1 (6.4) cigarettes per day for 22.7 (11.9) pack-years', '36 smokers were (mean (standard deviation']","['Smoking and Smoking Cessation', 'smoking cessation']","['systolic blood pressures', 'Cyanobacteria correlated with CO levels', 'relative abundances of the phylum Bacteroidetes', 'Relative abundances of bacterial taxa and alpha- and beta-diversity measures', 'alpha-diversity', 'heart rates']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1047211', 'cui_str': 'Cyanobacteria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",42.0,0.0184073,"After 12 weeks, relative abundances of the phylum Bacteroidetes increased ( p ANCOVA  = 0.048) and Firmicutes decreased ( p ANCOVA  = 0.036) among abstainers compared to continuing smokers.","[{'ForeName': 'Marcus G', 'Initials': 'MG', 'LastName': 'Sublette', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Tzu-Wen L', 'Initials': 'TL', 'LastName': 'Cross', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, Indiana, 47907, USA.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Korcarz', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Hansen', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Sofia M', 'Initials': 'SM', 'LastName': 'Murga-Garrido', 'Affiliation': 'Department of Bacteriology, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Bacteriology, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'Zeneng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA.'}, {'ForeName': 'Madeline K', 'Initials': 'MK', 'LastName': 'Oguss', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}, {'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Rey', 'Affiliation': 'Department of Bacteriology, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA.'}]",Journal of clinical medicine,['10.3390/jcm9092963']
2799,32937905,"Motivation, Self-Concept and Discipline in Young Adolescents Who Practice Rhythmic Gymnastics. An Intervention.","This study aims to develop an intervention based on TARGET strategies in young people practicing rhythmic gymnastics, with the aim of observing whether motivation, discipline, self-concept and flexibility are improved. This research is a longitudinal study of a quasi-experimental nature. A total of 104 young adolescents between the ages of 11 and 12 years (11.66 ± 0.47) participated in the study, of which 60 belong to the control group and 44 to the experimental group. The intervention programme lasted two months (17 sessions). TARGET strategies were applied to the experimental group during training. While the experimental group continued with its routine training. To measure the psychological variables, the instrument used were the Youth Physical Self-Concept Scale (C-PSQ), Reason Scale for Discipline (RSD) and Success Perception Questionnaire (SPQ), and for flexibility, the tests were applied to the Sit and Reach and Deep trunk flexion test. The results showed that those teenagers who participated in the intervention, obtained an increased climate task, which entails an enjoyment by the practice of physical activity itself, more optimal levels of physical self-concept and discipline, subsequently, obtaining better results of flexibility. While in the control group gymnasts the ego climate and demotivation increased. TARGET strategies applied to young adolescents have positive effects, improve motivation towards physical activity, self-concept and discipline. This results in greater performance in flexibility. This will encourage young adolescents to continue to engage in physical activity in the future.",2020,"The results showed that those teenagers who participated in the intervention, obtained an increased climate task, which entails an enjoyment by the practice of physical activity itself, more optimal levels of physical self-concept and discipline, subsequently, obtaining better results of flexibility.","['Young Adolescents', '104 young adolescents between the ages of 11 and 12 years (11.66 ± 0.47) participated in the study, of which 60 belong to the control group and 44 to the experimental group', 'young people practicing rhythmic gymnastics', 'young adolescents']",[],"['Youth Physical Self-Concept Scale (C-PSQ), Reason Scale for Discipline (RSD) and Success Perception Questionnaire (SPQ), and for flexibility, the tests were applied to the Sit and Reach and Deep trunk flexion test']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}]",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}]",104.0,0.011366,"The results showed that those teenagers who participated in the intervention, obtained an increased climate task, which entails an enjoyment by the practice of physical activity itself, more optimal levels of physical self-concept and discipline, subsequently, obtaining better results of flexibility.","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'González-Valero', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Zurita-Ortega', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Ubago-Jiménez', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Puertas-Molero', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, University of Granada (Spain), Campus de Cartuja, 18071 Granada, Spain.'}]","Children (Basel, Switzerland)",['10.3390/children7090135']
2800,32938386,"A small dose of dezocine suppresses remifentanil-induced cough in general anesthesia induction: a prospective, randomized, controlled study.","BACKGROUND


The aim of this prospective randomized controlled study was to evaluate whether pretreatment with a small dose of dezocine could prevent remifentanil-induced cough in general anesthesia induction.
TRIAL DESIGN


a prospective, randomized, controlled study.
METHODS


A total of 210 patients receiving elective operative hysteroscopy from December 2018 to April 2019 were enrolled in the present study. They were randomly equally separated into dezocine group (n = 105) and control group (n = 105). Patients were intravenously pre-administrated with dezocine 0.03 mg/kg (diluted to 5 mL) or the same volume of normal saline 1 min prior to remifentanil infusion. One minute later, intravenous injection of propofol 1.5 mg/kg and cisatracurium 0.1 mg/kg were given to all patients for induction of general anesthesia. The counts of coughs occurred during the anesthesia induction period were recorded and the severity of cough was scaled.
RESULTS


There were 7 cases of mild cough in dezocine group and 18 cases of mild cough, 12 cases of moderate cough and 4 cases of severe cough in control group. The incidence rate of cough was significantly lower and the severity of cough was obviously relieved in dezocine group compared to control group (6.67% vs. 32.38%, P <  0.001). The two groups were not significantly different in heart rate and mean arterial pressure before the induction, before and after the intubation, and in operating time and postoperative visual analog scale pain scores.
CONCLUSION


This study recommends the efficacy and safety of a pretreatment with a small dose of dezocine in reducing remifentanil-induced cough during general anesthesia.
TRIAL REGISTRATION


ChiCTR2000032035 . Date of registration: Retrospectively registered on 2020/04/18.",2020,"The two groups were not significantly different in heart rate and mean arterial pressure before the induction, before and after the intubation, and in operating time and postoperative visual analog scale pain scores.
","['general anesthesia induction', '210 patients receiving elective operative hysteroscopy from December 2018 to April 2019 were enrolled in the present study']","['propofol 1.5\u2009mg/kg and cisatracurium 0.1\u2009mg/kg were given to all patients for induction of general anesthesia', 'dezocine', 'dezocine 0.03\u2009mg/kg (diluted to 5\u2009mL) or the same volume of normal saline 1\u2009min prior to remifentanil infusion']","['mild cough', 'efficacy and safety', 'heart rate and mean arterial pressure', 'counts of coughs', 'severe cough', 'severity of cough', 'incidence rate of cough', 'operating time and postoperative visual analog scale pain scores']","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0057626', 'cui_str': 'dezocine'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",210.0,0.0518833,"The two groups were not significantly different in heart rate and mean arterial pressure before the induction, before and after the intubation, and in operating time and postoperative visual analog scale pain scores.
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, international Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Shanghai Jiao Tong University, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Anesthesiology, international Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Shanghai Jiao Tong University, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, international Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Shanghai Jiao Tong University, Huashan Rd. 1961, Shanghai, 200030, China. ZiFengXu_ipm@163.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01156-x']
2801,32938410,Cognitive remediation following electroconvulsive therapy in patients with treatment resistant depression: randomized controlled trail of an intervention for relapse prevention - study protocol.,"BACKGROUND


Major depressive episode (MDE) is worldwide one of the most prevalent and disabling mental health conditions. In cases of persistent non-response to treatment, electroconvulsive therapy (ECT) is a safe and effective treatment strategy with high response rates. Unfortunately, longitudinal data show low sustained response rates with 6-month relapse rates as high as 50% using existing relapse prevention strategies. Cognitive side effects of ECT, even though transient, might trigger mechanisms that increase relapse in patients who initially responded to ECT. Among these side effects, reduced cognitive control is an important neurobiological driven vulnerability factor for depression. As such, cognitive control training (CCT) holds promise as a non-pharmacological strategy to improve long-term effects of ECT (i.e., increase remission, and reduce depression relapse).
METHOD/DESIGN


Eighty-eight patients aged between 18 and 70 years with MDE who start CCT will be included in this randomized controlled trial (RCT). Following (partial) response to ECT treatment (at least a 25% reduction of clinical symptoms), patients will be randomly assigned to a computer based CCT or active placebo control. A first aim of this RCT is to assess the effects of CCT compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. Secondly, we will monitor patients every 2 weeks for a period of 6 months following CCT/active placebo, allowing the detection of potential relapse of depression. Thirdly, we will assess patient evaluation of the addition of cognitive remediation to ECT using qualitative interview methods (satisfaction, acceptability and appropriateness). Finally, in order to further advance our understanding of the mechanisms underlying effects of CCT, exploratory analyses will be conducted using video footage collected during the CCT/active control phase of the study.
DISCUSSION


Cognitive remediation will be performed following response to ECT, and an extensive follow-up period will be employed. Positive findings would not only benefit patients by decreasing relapse, but also by increasing acceptability of ECT, reducing the burden of cognitive side-effects.
TRIAL REGISTRATION


The study is registered with ClinicalTrials.gov . Study ID: NCT04383509 Trial registration date: 12.05.2020.",2020,"Cognitive side effects of ECT, even though transient, might trigger mechanisms that increase relapse in patients who initially responded to ECT.","['patients with treatment resistant depression', 'patients who initially responded to ECT', 'Eighty-eight patients aged between 18 and 70\u2009years with MDE who start CCT will be included in this randomized controlled trial (RCT']","['ECT', 'electroconvulsive therapy', 'cognitive control training (CCT', 'CCT/active placebo', 'CCT', 'RCT', 'electroconvulsive therapy (ECT']","['depression symptomatology, cognitive complaints, and quality of life', 'Cognitive remediation', 'burden of cognitive side-effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",88.0,0.478278,"Cognitive side effects of ECT, even though transient, might trigger mechanisms that increase relapse in patients who initially responded to ECT.","[{'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Van de Velde', 'Affiliation': 'Department of Psychiatry, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. Nele.vandevelde2@uzgent.be.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Kappen', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ernst H W', 'Initials': 'EHW', 'LastName': 'Koster', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Kristof', 'Initials': 'K', 'LastName': 'Hoorelbeke', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Hannelore', 'Initials': 'H', 'LastName': 'Tandt', 'Affiliation': 'Department of Psychiatry, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Verslype', 'Affiliation': 'Department of Anesthesiology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Psychiatry, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Lemmens', 'Affiliation': 'Department of Psychiatry, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}]",BMC psychiatry,['10.1186/s12888-020-02856-x']
2802,32938433,Coverage of the WHO's four essential elements of newborn care and their association with neonatal survival in southern Nepal.,"BACKGROUND


Despite recent improvements in child survival, neonatal mortality continues to decline at a slower rate and now represents 47% of under-five deaths globally. The World Health Organization developed core indicators to better monitor the quality of maternal and newborn health services. One such indicator for newborn health is ""the proportion of newborns who received all four elements of essential care"". The four elements are immediate and thorough drying, skin to skin contact, delayed cord clamping, and early initiation of breastfeeding. Although there is existing evidence demonstrating an association with decreased neonatal mortality for each element individually, the cumulative impact has not yet been examined.
METHODS


This analysis uses data from a randomized trial to examine the impact of sunflower versus mustard seed oil massage on neonatal mortality and morbidity in the Sarlahi district in Southern Nepal from 2010 to 2017. The proportion of newborn infants receiving an intervention was the exposure and neonatal mortality was the outcome in this analysis. Neonatal mortality was defined as a death between three hours and less than 28 days of age. Associations between neonatal mortality and the essential elements were estimated by Cox proportion hazards models. The hazard ratios and corresponding 95% confidence intervals were reported.
RESULTS


28,121 mother-infant pairs and 753 neonatal deaths were included. The percent receiving the individual elements ranged from 19.5% (skin to skin contact) to 68.2% (delayed cord clamping). The majority of infants received one or two of the elements of essential care, with less than 1% receiving all four. Skin to skin contact and early initiation of breastfeeding were associated with lower risk of neonatal mortality (aHR = 0.64 [0.51, 0.81] and aHR = 0.72 [0.60, 0.87], respectively). The risk of mortality declined as the number of elements received increased; receipt of one element compared to zero was associated with a nearly 50% reduction in risk of mortality and receipt of all four elements resulted in a 72% decrease in risk of mortality.
CONCLUSIONS


The receipt of one or more of the four essential elements of newborn care was associated with improved neonatal survival. The more elements of care received, the more survival improved.",2020,"Skin to skin contact and early initiation of breastfeeding were associated with lower risk of neonatal mortality (aHR = 0.64 [0.51, 0.81] and aHR = 0.72 [0.60, 0.87], respectively).","['Sarlahi district in Southern Nepal from 2010 to 2017', '28,121 mother-infant pairs and 753 neonatal deaths']",['sunflower versus mustard seed oil massage'],"['risk of mortality', 'neonatal survival', 'immediate and thorough drying, skin to skin contact, delayed cord clamping, and early initiation of breastfeeding', 'exposure and neonatal mortality', 'neonatal mortality', 'neonatal mortality and morbidity', 'Neonatal mortality', 'hazard ratios']","[{'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}]","[{'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0453262', 'cui_str': 'Mustard seed'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28121.0,0.0429914,"Skin to skin contact and early initiation of breastfeeding were associated with lower risk of neonatal mortality (aHR = 0.64 [0.51, 0.81] and aHR = 0.72 [0.60, 0.87], respectively).","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bryce', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA. ebryce2@jhmi.edu.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, 950 New Hampshire Avenue, Washington, DC, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03239-6']
2803,32938444,An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model.,"BACKGROUND


Malaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro.
METHODS


In this open label study, 18 healthy volunteers, aged 18-50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitaemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitaemia 28 days after the malaria challenge.
RESULTS


All 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitaemia during the 28-day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and parasitaemia during the 28-day post-challenge period. However, after chemoprophylaxis was discontinued an additional 6 volunteers developed parasitaemia between days 28-41 after challenge, with 4 of 6 experiencing symptoms. 80% of subjects in the CQAZ group experienced treatment related gastrointestinal adverse events (including 13% that experienced severe nausea) compared to 38% in the CQ group. A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p = 0.03) and AUC (p = 0.044) levels in those volunteers who never became parasitaemic compared to those who did.
CONCLUSION


Given the high rate of side effects and poor efficacy when administered for 3 weeks before and after challenge, the combination of weekly chloroquine and azithromycin is a suboptimal regimen combination for weekly malaria chemoprophylaxis. Trial registration ClinicalTrials.gov NCT03278808.",2020,"A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p = 0.03) and AUC (p = 0.044) levels in those volunteers who never became parasitaemic compared to those who did.
","['healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model', '18 healthy volunteers, aged 18-50\xa0years (inclusive']","['CQAZ', '300\xa0mg CQ or 300\xa0mg CQ and 2\xa0gm azithromycin (CQAZ) of directly observed therapy', 'chloroquine and azithromycin', 'chloroquine (CQ) with azithromycin (AZ', 'chloroquine-resistant Plasmodium falciparum', 'CQ control']","['parasitaemia', 'safety and efficacy', 'symptoms and parasitaemia', 'symptomatic with parasitaemia', 'number of volunteers that remained asymptomatic and had no evidence of parasitaemia 28\xa0days after the malaria challenge', 'gastrointestinal adverse events', 'severe nausea', 'azithromycin Cmax']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",18.0,0.0458595,"A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p = 0.03) and AUC (p = 0.044) levels in those volunteers who never became parasitaemic compared to those who did.
","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Livezey', 'Affiliation': 'Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD, 20814, USA. jeffrey.livezey@usuhs.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Twomey', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Meshell', 'Initials': 'M', 'LastName': 'Morrison', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cicatelli', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Duncan', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Hamer', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Poon', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Selig', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Vuong', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Sousa', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Oliver', 'Affiliation': 'Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD, 20814, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Moon', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Sikaffy', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sedegah', 'Affiliation': 'Naval Medical Research Center, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Tosh', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Kreishman-Deitrick', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Waterman', 'Affiliation': 'Walter Reed Army Institute of Research, 503 Robert Grant Ave, Silver Spring, MD, 20910, USA.'}]",Malaria journal,['10.1186/s12936-020-03409-z']
2804,32938447,The effect of neuropalliative care on quality of life and satisfaction with quality of care in patients with progressive neurological disease and their family caregivers: an interventional control study.,"BACKGROUND


It is recommended that patients with progressive neurological disease (PND) receive general and specialized palliative care. The purpose of this study was to determine the effect of neuropalliative care on quality of life (QoL) and satisfaction with provided care in both patients with PND in advanced stages of disease and their family caregivers.
METHODS


The sample consisted of 151 patients with PND and 140 family caregivers. The PNDQoL questionnaire was used for data collection. Patients and family caregivers completed the questionnaires both before and 3 months after the intervention.
RESULTS


Before intervention, there were no statistically significant differences in the individual domains of QoL in patients and family caregivers in either the intervention or the control group. After intervention, differences were identified in the sample of patients in the domains of symptoms burden (p < 0.001), emotional (p < 0 .001), social functioning (p = 0.046), spiritual area (nonreligious) (p = 0.050), and in QoL. In the sample of family caregivers, there were differences in the domains of symptoms burden (p < 0.001), emotional functioning (p = 0.016), spiritual area (nonreligious) (p = 0.042), and in the assessment of health (p = 0.002), and QoL (p = 0.002). Patients and family caregivers from the intervention group evaluated their satisfaction with the quality of care provided significantly more positively in all five analyzed domains.
CONCLUSION


The provision of neuropalliative care to patients with advanced stages of PND helped to maintain and slightly improve their QoL, and symptoms burden, and resulted in a more positive assessment of satisfaction with the quality of care provided.",2020,"In the sample of family caregivers, there were differences in the domains of symptoms burden (p < 0.001), emotional functioning (p = 0.016), spiritual area (nonreligious) (p = 0.042), and in the assessment of health (p = 0.002), and QoL (p = 0.002).","['151 patients with PND and 140 family caregivers', 'patients with progressive neurological disease and their family caregivers', 'patients with progressive neurological disease (PND) receive general and specialized palliative care', 'patients with advanced stages of PND', 'patients with PND in advanced stages of disease and their family caregivers']",['neuropalliative care'],"['quality of life (QoL) and satisfaction with provided care', 'satisfaction with the quality of care', 'quality of life and satisfaction with quality of care', 'social functioning', 'individual domains of QoL', 'emotional functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",151.0,0.0387965,"In the sample of family caregivers, there were differences in the domains of symptoms burden (p < 0.001), emotional functioning (p = 0.016), spiritual area (nonreligious) (p = 0.042), and in the assessment of health (p = 0.002), and QoL (p = 0.002).","[{'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Bužgová', 'Affiliation': 'Department of Nursing and Midwifery, Faculty of Medicine, University of Ostrava, Syllabova 19, 700 30, Ostrava, Czech Republic. Radka.buzgova@osu.cz.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Kozáková', 'Affiliation': 'Department of Nursing and Midwifery, Faculty of Medicine, University of Ostrava, Syllabova 19, 700 30, Ostrava, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bar', 'Affiliation': 'Neurology clinic, The University Hospital Ostrava, Ostrava, Czech Republic.'}]",BMC palliative care,['10.1186/s12904-020-00651-9']
2805,32938468,Intensity-modulated radiation therapy versus three-dimensional conformal radiotherapy in head and neck squamous cell carcinoma: long-term and mature outcomes of a prospective randomized trial.,"PURPOSE


To compare long-term disease-related outcomes and late radiation morbidity between intensity-modulated radiation therapy (IMRT) and three-dimensional conformal radiotherapy (3D-CRT) in head and neck squamous cell carcinoma (HNSCC) in the setting of a prospective randomized controlled trial.
METHODS


Previously untreated patients with early to moderately advanced non-metastatic squamous carcinoma of the oropharynx, larynx, or hypopharynx (T1-T3, N0-N2b, M0) planned for comprehensive irradiation of primary site and bilateral neck nodes were randomly assigned to either IMRT or 3D-CRT after written informed consent. Patients were treated with 6MV photons to a total dose of 70Gy/35 fractions over 7 weeks (3D-CRT) or 66Gy/30 fractions over 6 weeks (IMRT). A sample size of 60 patients was estimated to demonstrate 35% absolute difference in the incidence of ≥grade 2 acute xerostomia between the two arms. All time-to-event outcomes were calculated from date of randomization until the defined event using the Kaplan-Meier method.
RESULTS


At a median follow-up of 140 months for surviving patients, 10-year Kaplan-Meier estimates of loco-regional control (LRC); progression-free survival (PFS); and overall survival (OS) with 95% confidence interval (95%CI) were 73.6% (95%CI: 61.2-86%); 45.2% (95%CI: 32-58.4%); and 50.3% (95%CI: 37.1-63.5%) respectively. There were no significant differences in 10-year disease-related outcomes between 3D-CRT and IMRT for LRC [79.2% (95%CI: 62.2-96.2%) vs 68.7% (95%CI: 51.1-86.3%), p = 0.39]; PFS [41.3% (95%CI: 22.3-60.3%) vs 48.6% (95%CI: 30.6-66.6%), p = 0.59]; or OS [44.9% (95%CI: 25.7-64.1%) vs 55.0% (95%CI: 37-73%), p = 0.49]. Significantly lesser proportion of patients in the IMRT arm experienced ≥grade 2 late xerostomia and subcutaneous fibrosis at all time-points. However, at longer follow-up, fewer patients remained evaluable for late radiation toxicity reducing statistical power and precision.
CONCLUSIONS


IMRT provides a clinically meaningful and sustained reduction in the incidence of moderate to severe xerostomia and subcutaneous fibrosis compared to 3D-CRT without compromising disease-related outcomes in long-term survivors of non-nasopharyngeal HNSCC.",2020,There were no significant differences in 10-year disease-related outcomes between 3D-CRT and IMRT for LRC [79.2% (,"['head and neck squamous cell carcinoma', 'Previously untreated patients with early to moderately advanced non-metastatic squamous carcinoma of the oropharynx, larynx, or hypopharynx (T1-T3, N0-N2b, M0) planned for comprehensive irradiation of primary site and bilateral neck nodes', 'head and neck squamous cell carcinoma (HNSCC']","['6MV photons', 'Intensity-modulated radiation therapy versus three-dimensional conformal radiotherapy', 'IMRT', 'IMRT or 3D-CRT', 'intensity-modulated radiation therapy (IMRT) and three-dimensional conformal radiotherapy (3D-CRT']","['10-year Kaplan-Meier estimates of loco-regional control (LRC); progression-free survival (PFS); and overall survival (OS', '10-year disease-related outcomes', 'incidence of ≥grade 2 acute xerostomia', 'PFS', '≥grade 2 late xerostomia and subcutaneous fibrosis']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0445080', 'cui_str': 'Node stage N2b'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1720943', 'cui_str': 'Kaplan-Meier Analysis'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]",,0.282554,There were no significant differences in 10-year disease-related outcomes between 3D-CRT and IMRT for LRC [79.2% (,"[{'ForeName': 'Tejpal', 'Initials': 'T', 'LastName': 'Gupta', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Kharghar, Mumbai, 410210, India. tejpalgupta@rediffmail.com.'}, {'ForeName': 'Shwetabh', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Kharghar, Mumbai, 410210, India.'}, {'ForeName': 'Sarbani', 'Initials': 'S', 'LastName': 'Ghosh-Laskar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Kharghar, Mumbai, 410210, India.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Budrukkar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Kharghar, Mumbai, 410210, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Mummudi', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Kharghar, Mumbai, 410210, India.'}, {'ForeName': 'Monali', 'Initials': 'M', 'LastName': 'Swain', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Kharghar, Mumbai, 410210, India.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Phurailatpam', 'Affiliation': 'Department of Medical Physics, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Mumbai, India.'}, {'ForeName': 'Jai Prakash', 'Initials': 'JP', 'LastName': 'Agarwal', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Hospital (TMH)/Advanced Centre for Treatment Education & Research in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Kharghar, Mumbai, 410210, India.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01666-5']
2806,32938470,"Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial.","BACKGROUND


Osteoarthritis (OA) is a common chronic disease in older adults. Currently, there are no effective therapies to reduce disease severity and progression of knee OA (KOA), particularly in mid- to late-stages. This study aims to examine the effect of methotrexate (MTX) on knee effusion-synovitis and pain in symptomatic patients with mid- to late-stage KOA.
METHODS/DESIGN


This protocol describes a multicentre randomised placebo-controlled clinical trial aiming to recruit 200 participants with mid- to late-stage symptomatic KOA and with effusion-synovitis grade of ≥ 2. Participants will be randomly allocated to the MTX group (start from 5 mg per week for the first 2 weeks and increase to 10 mg per week for the second 2 weeks and 15 mg per week for the remaining period if tolerated) or the placebo group. Primary outcomes are effusion-synovitis size measured by magnetic resonance imaging (MRI) and knee pain assessed by visual analogue scale (VAS). Secondary outcomes are signal intensity alteration within infrapatellar fat pad (IPFP) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and subscores, and the Outcome Measures in Rheumatology Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responders. Both intention-to-treat and per-protocol analyses will be performed.
DISCUSSION


If MTX intervention can relieve symptoms and reduce inflammation in patients with mid- to late-stage KOA, it has the potential for significant clinical and public health impact as this low-cost and commonly used intervention would delay the time to knee replacement, leading to substantial cost savings and improve quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03815448 . Registered on 21 January 2019.",2020,"Secondary outcomes are signal intensity alteration within infrapatellar fat pad (IPFP) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and subscores, and the Outcome Measures in Rheumatology Arthritis","['older adults', '200 participants with mid- to late-stage symptomatic KOA and with effusion-synovitis grade of ≥\u20092', 'patients with mid- to late-stage knee osteoarthritis', 'symptomatic patients with mid- to late-stage KOA', 'patients with mid- to late-stage KOA']","['methotrexate (MTX', 'methotrexate', 'MTX', 'MTX intervention', 'placebo']","['knee effusion-synovitis and pain', 'signal intensity alteration within infrapatellar fat pad (IPFP) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and subscores, and the Outcome Measures in Rheumatology Arthritis', 'effusion-synovitis size measured by magnetic resonance imaging (MRI) and knee pain assessed by visual analogue scale (VAS', 'disease severity and progression of knee OA (KOA']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0343166', 'cui_str': 'Knee joint effusion'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",200.0,0.248783,"Secondary outcomes are signal intensity alteration within infrapatellar fat pad (IPFP) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and subscores, and the Outcome Measures in Rheumatology Arthritis","[{'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qinghong', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Leng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhanguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Rheumatology & Immunology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Cibo', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Rheumatology, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Jieruo', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Rheumatology, 3rd Affiliated Hospital of Sun Yet-Sen University Guangzhou, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology & Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Tianwang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology and Immunology, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Yifang', 'Initials': 'Y', 'LastName': 'Mei', 'Affiliation': 'Department of Rheumatology, the First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, the First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hunter', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China. Changhai.Ding@utas.edu.au.'}]",Trials,['10.1186/s13063-020-04687-3']
2807,32938477,"Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence.","BACKGROUND


Alcohol dependence is a significant issue contributing to disease burden. Changes in cortisol concentrations during alcohol withdrawal are associated with cognitive deficits and symptoms of depression. Current treatments are only successful for a small proportion of people and do not target cognitive deficits and symptoms of depression experienced by those who are alcohol dependent. The aim of this research is to determine the potential efficacy of mifepristone, a type II glucocorticoid receptor antagonist, to prevent symptoms of depression and cognitive deficits following alcohol detoxification.
METHODS


This was a phase 2 therapeutic use trial. It was a double-blind randomised controlled clinical trial of mifepristone versus inactive placebo treatment. The trial aimed to recruit 120 participants who met the inclusion criteria: (1) male, (2) aged 18-60 years inclusive, and (3) alcohol dependent for 5 or more years. Participants were randomised to 600 mg a day mifepristone (200 mg morning, afternoon, and evening) for 7 days and 400 mg for the subsequent 7 days (200 mg morning and evening) or the equivalent number of placebo tablets for 14 days. Primary outcome measures were cognitive function (measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB)) and symptoms of depression (measured using the Beck Depression Inventory (BDI)) at 4 weeks post-randomisation.
RESULTS


Difficulties recruiting participants due to significant changes in the provision of inpatient care for alcohol dependence resulted in only 27 participants recruited to the trial, with data available for 21 participants. Fourteen participants were randomised to receive mifepristone and 13 to receive placebo.
CONCLUSION


Larger trials would be needed to draw conclusions about the efficacy of mifepristone.
TRIAL REGISTRATION


ISRCTN registry ISRCTN54001953 . Registered on 29 September 2011.",2020,"RESULTS


Difficulties recruiting participants due to significant changes in the provision of inpatient care for alcohol dependence resulted in only 27 participants recruited to the trial, with data available for 21 participants.","['120 participants who met the inclusion criteria: (1) male, (2) aged 18-60\u2009years inclusive, and (3) alcohol dependent for 5 or more years', 'Fourteen participants']","['mifepristone', 'placebo', 'placebo tablets', 'inactive placebo']","['cognition and depression in alcohol dependence', 'cortisol concentrations', 'cognitive function (measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB)) and symptoms of depression (measured using the Beck Depression Inventory (BDI']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}]",14.0,0.697907,"RESULTS


Difficulties recruiting participants due to significant changes in the provision of inpatient care for alcohol dependence resulted in only 27 participants recruited to the trial, with data available for 21 participants.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Donoghue', 'Affiliation': ""Addictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK. kim.donoghue@kcl.ac.uk.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Rose', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, 2.32, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coulton', 'Affiliation': 'Centre for Health Service Studies, University of Kent, Canterbury, Kent, CT2 7NF, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, York, YO10 5DD, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Milward', 'Affiliation': ""Addictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Philips', 'Affiliation': ""Addictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Drummond', 'Affiliation': ""Addictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.""}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Little', 'Affiliation': ""Addictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.""}]",Trials,['10.1186/s13063-020-04726-z']
2808,32936085,User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study.,"BACKGROUND


Internet interventions have been shown to be effective in treating anxiety disorders. Most interventions to date focus on single disorders and disregard potential comorbidities.
OBJECTIVE


The aim of this mixed-methods study was to investigate feasibility, user experience, and effects of a newly developed individually tailored transdiagnostic guided internet intervention for anxiety disorders.
METHODS


This study is an uncontrolled, within-group, baseline, postintervention pilot trial with an embedded qualitative and quantitative process and effect evaluation. In total, 49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received access to the 7-session intervention. We examined motivation and expectations, intervention use, user experience, impact, and modification requests. Qualitative data were assessed using semistructured interviews and analyzed by qualitative content analysis. Quantitative outcomes included symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9 [PHQ-9]) at baseline and postassessment. Quantitative data was analyzed by comparing within-group means expressed as Cohen d.
RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder. The main positive effects were the general improvement of disease burden and attentiveness to feelings and risk situations while the main negative effects experienced were lack of change in disease burden and symptom deterioration. The most prevalent reasons for participation were the advantages of online treatment, symptom burden, and openness toward online treatment. Helpful factors included support, psychoeducation and practicing strategies in daily life; the main hindering factors were too little individualization and being overwhelmed by the content and pace.
CONCLUSIONS


The intervention was found to be feasible and results show preliminary data indicating potential efficacy for improving anxiety and depression. The next step should be the evaluation within a randomized controlled trial. Concerning intervention development, it was found that future interventions should emphasize individualization even more in order to further improve the fit to individual characteristics, preferences, and needs.",2020,"RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder.","['49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received']","['access to the 7-session intervention', 'Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention']","['Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms', 'symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9', 'disease burden and attentiveness to feelings and risk situations', 'disease burden and symptom deterioration', 'anxiety and depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",49.0,0.0454209,"RESULTS


Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder.","[{'ForeName': 'Kiona K', 'Initials': 'KK', 'LastName': 'Weisel', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Anna-Carlotta', 'Initials': 'AC', 'LastName': 'Zarski', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute of Public Health and Addiction ISGF, Associated to the University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Görlich', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Clinical, Neuro- & Development Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/16450']
2809,32936087,Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 3): Secondary Data Analysis.,"BACKGROUND


Many app-based interventions targeting women with breast cancer have been developed and tested for effectiveness. However, information regarding the evaluation of the usage of these interventions is scarce. A better understanding of usage data is important to determine how women use apps and how these interventions affect health outcomes.
OBJECTIVE


This study aimed to examine the usage duration and login frequency of an app-based intervention, the Breast Cancer e-Support (BCS) program, and to investigate the association between usage data and participants' demographic and medical characteristics.
METHODS


This study is a secondary data analysis of a randomized controlled trial assessing the effectiveness of the BCS program. The BCS program contains four modules: Learning Forum, Discussion Forum, Ask-the-Expert Forum, and Your Story Forum. A total of 57 women in the intervention group accessed the BCS program during their 12-week chemotherapy. The app's background system tracked the usage duration and login frequency for each forum and the entire BCS program.
RESULTS


The total usage duration per participant ranged from 0 to 9371 minutes, and the login frequency per participant ranged from 0 to 774 times. The Discussion Forum and the Learning Forum were the most frequently used modules. The general linear model showed that age, education, family monthly income, and employment were associated with BCS usage duration and/or login frequency. Age (F 1,45 =10.09, P=.003, B=115.34, 95% CI 42.22-188.47) and education level (F 1,45 =7.22, P=.01, B=1949.63, 95% CI 487.76-3411.50) were positively associated with the usage duration of the entire BCS program. Family monthly income was positively associated with the usage duration of the Learning Forum (F 1,45 =11.85, P=.001, B=1488.55, 95% CI 617.58-2359.51) and the login frequency of the entire BCS program (F 1,45 =4.47, P=.04, B=113.68, 95% CI 5.33-222.03). Employment was negatively associated with the usage duration of the Ask-the-expert Forum (F 1,45 =4.50, P=.04, B=-971.87, 95% CI -1894.66 to -49.07) and the Your Story Forum (F 1,45 =5.36, P=.03, B=-640.71, 95% CI -1198.30 to -83.11) and positively associated with the login frequency of the entire BCS program (F 1,45 =10.86, P=.002, B=192.88, 95% CI 75.01-310.74). No statistical differences were found between BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy.
CONCLUSIONS


Overall, this study found considerable variability in the usage of app-based interventions. When health care professionals incorporate app-based interventions into their routine care for women with breast cancer, the learning and discussion functions of apps should be strengthened to promote engagement. Additionally, characteristics of women with breast cancer, such as age, level of education, income, and employment status, should be taken in consideration to develop tailored apps that address their particular needs and therefore improve their engagement with the app.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12616000639426; http://www.ANZCTR.org.au/ACTRN12616000639426.aspx.",2020,"Age (F 1,45 =10.09, P=.003, B=115.34","['Chinese Women', 'women with breast cancer', 'With Breast Cancer Undergoing Chemotherapy (Part 3', '57 women in the intervention group accessed the BCS program during their 12-week chemotherapy']","['Mobile Breast Cancer e-Support Program', 'app-based intervention, the Breast Cancer e-Support (BCS) program']","['education level', 'Your Story Forum', 'usage duration of the Ask-the-expert Forum', 'BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy', 'usage duration of the Learning Forum', 'login frequency of the entire BCS program']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1268990', 'cui_str': 'Entire breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",57.0,0.0397284,"Age (F 1,45 =10.09, P=.003, B=115.34","[{'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Nursing Department, First Affiliated Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Xiuwan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, First Affiliated Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Jinqiu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Hospital Infection Management Office, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiemin', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Nursing, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Sally Wai-Chi', 'Initials': 'SW', 'LastName': 'Chan', 'Affiliation': 'Global Engagement and Partnership Division, UON Singapore campus, University of Newcastle, Newcastle, Australia.'}]",JMIR mHealth and uHealth,['10.2196/18896']
2810,32936209,Remote Optimization of Guideline-Directed Medical Therapy in Patients With Heart Failure With Reduced Ejection Fraction.,"Importance


Optimal treatment of heart failure with reduced ejection fraction (HFrEF) is scripted by treatment guidelines, but many eligible patients do not receive guideline-directed medical therapy (GDMT) in clinical practice.
Objective


To determine whether a remote, algorithm-driven, navigator-administered medication optimization program could enhance implementation of GDMT in HFrEF.
Design, Setting, and Participants


In this case-control study, a population-based sample of patients with HFrEF was offered participation in a quality improvement program directed at GDMT optimization. Treating clinicians in a tertiary academic medical center who were caring for patients with heart failure and an ejection fraction of 40% or less (identified through an electronic health record-based search) were approached for permission to adjust medical therapy according to a sequential titration algorithm modeled on the current American College of Cardiology/American Heart Association heart failure guidelines. Navigators contacted participants by telephone to direct medication adjustment and conduct longitudinal surveillance of laboratory tests, blood pressure, and symptoms under supervision of a pharmacist, nurse practitioner, and heart failure cardiologist. Patients and clinicians declining to participate served as a control group.
Exposures


Navigator-led remote optimization of GDMT compared with usual care.
Main Outcomes and Measures


Proportion of patients receiving GDMT in the intervention and control groups at 3 months.
Results


Of 1028 eligible patients (mean [SD] values: age, 68 [14] years; ejection fraction, 32% [8%]; and systolic blood pressure, 122 [18] mm Hg; 305 women (30.0%); 892 individuals [86.8%] in New York Heart Association class I and II), 197 (19.2%) participated in the medication optimization program, and 831 (80.8%) continued with usual care as directed by their treating clinicians (585 [56.9%] general cardiologists; 443 [43.1%] heart failure specialists). At 3 months, patients participating in the remote intervention experienced significant increases from baseline in use of renin-angiotensin system antagonists (138 [70.1%] to 170 [86.3%]; P < .001) and β-blockers (152 [77.2%] to 181 [91.9%]; P < .001) but not mineralocorticoid receptor antagonists (51 [25.9%] to 60 [30.5%]; P = .14). Doses for each category of GDMT also increased from baseline in the intervention group. Among the usual-care group, there were no changes from baseline in the proportion of patients receiving GDMT or the dose of GDMT in any category.
Conclusions and Relevance


Remote titration of GDMT by navigators using encoded algorithms may represent an efficient, population-level strategy for rapidly closing the gap between guidelines and clinical practice in patients with HFrEF.",2020,"At 3 months, patients participating in the remote intervention experienced significant increases from baseline in use of renin-angiotensin system antagonists (138 [70.1%] to 170 [86.3%]; P < .001) and β-blockers (152 [77.2%] to 181 [91.9%]; P < .001) but not mineralocorticoid receptor antagonists (51 [25.9%] to 60 [30.5%]; P = .14).","['1028 eligible patients (mean [SD] values: age, 68 [14] years; ejection fraction, 32% [8%]; and systolic blood pressure', 'patients with HFrEF', 'Patients With Heart Failure With Reduced Ejection Fraction', '122 [18] mm Hg; 305 women (30.0%); 892 individuals [86.8%] in New York Heart Association class I and II), 197 (19.2%) participated in the medication optimization program, and 831 (80.8%) continued with usual care as directed by their treating clinicians (585 [56.9%] general cardiologists; 443 [43.1%] heart failure specialists', 'eligible patients do not receive guideline-directed medical therapy (GDMT) in clinical practice', 'Patients and clinicians declining to participate served as a control group', 'Treating clinicians in a tertiary academic medical center who were caring for patients with heart failure and an ejection fraction of 40% or less (identified through an electronic health record-based search) were approached for permission to adjust medical therapy according to a sequential titration algorithm modeled on the current American College of Cardiology/American Heart Association heart failure guidelines']","['GDMT', 'reduced ejection fraction (HFrEF', 'Guideline-Directed Medical Therapy']","['renin-angiotensin system antagonists', 'β-blockers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]",1028.0,0.0233997,"At 3 months, patients participating in the remote intervention experienced significant increases from baseline in use of renin-angiotensin system antagonists (138 [70.1%] to 170 [86.3%]; P < .001) and β-blockers (152 [77.2%] to 181 [91.9%]; P < .001) but not mineralocorticoid receptor antagonists (51 [25.9%] to 60 [30.5%]; P = .14).","[{'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Maclean', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Blood', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bosque-Hamilton', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Fera', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Katelyn V', 'Initials': 'KV', 'LastName': 'Smith', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kavishwar', 'Initials': 'K', 'LastName': 'Wagholikar', 'Affiliation': 'Laboratory of Computer Science, Massachusetts General Hospital, Boston.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zelle', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gaziano', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Plutzky', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Scirica', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Calum A', 'Initials': 'CA', 'LastName': 'MacRae', 'Affiliation': ""Cardiovascular Medicine Innovation Program, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.3757']
2811,32936233,Validation of Psychometric Properties of the Itch Numeric Rating Scale for Pruritus Associated With Prurigo Nodularis: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


There is an unmet need for psychometrically sound instruments to measure pruritus associated with prurigo nodularis (PN).
Objective


To evaluate the psychometric properties of the itch numeric rating scale (itch NRS), both the Worst Itch Numeric Rating Scale (WI-NRS) and the Average Itch Numeric Rating Scale (AI-NRS).
Design, Setting, and Participants


This secondary analysis is based on a secondary end point of a phase 2 randomized clinical trial of serlopitant for treatment of pruritus associated with PN. This randomized, double-blind, placebo-controlled study was conducted at 15 sites in Germany. Eligible patients were aged 18 to 80 years and had generalized PN for more than 6 weeks that was refractory to previous antipruritic therapies. Patients were required to have a visual analog scale itch score of 7 or higher at screening. Data were collected from July 2014 to June 2016 and analyzed from June 2016 to January 2017.
Main Outcomes and Measures


The itch NRS (AI-NRS and WI-NRS) was correlated together with the following measures: the electronic verbal rating scale (eVRS) for itch self-categorization, average itch visual analog scale (AI-VAS), worst itch visual analog scale (WI-VAS), the pruritus-specific quality-of-life rating instrument ItchyQoL, Dermatology Life Quality Index (DLQI), and Prurigo Activity and Severity Score (items 7b and 7a: percentage healed prurigo lesions and percentage of prurigo lesions with excoriations).
Results


There were 123 participants in this study; the mean (SD) age of participants was 57.3 (11.58) years, and 58 (47.2%) were male. Strong associations (r ≥ 0.5) were observed between itch NRS items (WI-NRS and AI-NRS) and AI-VAS (24 hours) at weeks 2, 4, and 8 (r = 0.72-0.90; P < .001). Similar strong associations were also observed between itch NRS items and WI-VAS (24 hours) and eVRS for itch severity across weeks 2, 4, and 8 (r = 0.65-0.92; all P < .001). Strong correlations were seen between change scores for WI-NRS and WI-VAS and AI-VAS (r = 0.76 and 0.70, respectively; both P < .001). Similar findings were seen for AI-NRS, where correlations between change scores for WI-VAS and AI-VAS were 0.71 and 0.72, respectively (both P < .001). Analyses for the itch NRS items also showed that test-retest reliability was acceptable and provided evidence of acceptable convergent validity based on the eVRS and visit verbal rating score for itch self-categorization, ItchyQoL, and DLQI.
Conclusions and Relevance


Results from this secondary analysis show that the itch NRS items WI-NRS and AI-NRS have good psychometric properties for pruritus associated with PN and should be considered acceptable tools for assessing pruritus in future clinical trials of PN.
Trial Registration


ClinicalTrials.gov Identifier: NCT02196324.",2020,"Similar strong associations were also observed between itch NRS items and WI-VAS (24 hours) and eVRS for itch severity across weeks 2, 4, and 8 (r = 0.65-0.92; all P < .001).","['123 participants in this study; the mean (SD) age of participants was 57.3 (11.58) years, and 58 (47.2%) were male', 'Pruritus Associated With Prurigo Nodularis', '15 sites in Germany', 'Data were collected from July 2014 to June 2016 and analyzed from June 2016 to January 2017', 'Eligible patients were aged 18 to 80 years and had generalized PN for more than 6 weeks that was refractory to previous antipruritic therapies']",['placebo'],"['electronic verbal rating scale (eVRS) for itch self-categorization, average itch visual analog scale (AI-VAS), worst itch visual analog scale (WI-VAS), the pruritus-specific quality-of-life rating instrument ItchyQoL, Dermatology Life Quality Index (DLQI), and Prurigo Activity and Severity Score', 'itch numeric rating scale (itch NRS', 'eVRS and visit verbal rating score for itch self-categorization, ItchyQoL, and DLQI', 'itch NRS items and WI-VAS (24 hours) and eVRS for itch severity', 'Worst Itch Numeric Rating Scale (WI-NRS) and the Average Itch Numeric Rating Scale (AI-NRS', 'change scores for WI-VAS and AI-VAS', 'visual analog scale itch score', 'change scores for WI-NRS and WI-VAS and AI-VAS']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0263353', 'cui_str': 'Prurigo nodularis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0003417', 'cui_str': 'Antipruritic Agents'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0033771', 'cui_str': 'Pruritic rash'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.100126,"Similar strong associations were also observed between itch NRS items and WI-VAS (24 hours) and eVRS for itch severity across weeks 2, 4, and 8 (r = 0.65-0.92; all P < .001).","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kimel', 'Affiliation': 'Evidera Inc, Bethesda, Maryland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Zeidler', 'Affiliation': 'Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kwon', 'Affiliation': 'Menlo Therapeutics Inc, Redwood City, California.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Revicki', 'Affiliation': 'Evidera Inc, Bethesda, Maryland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Ständer', 'Affiliation': 'Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.3071']
2812,32936242,Effect of Prophylactic Embolization on Patients With Blunt Trauma at High Risk of Splenectomy: A Randomized Clinical Trial.,"Importance


Splenic arterial embolization (SAE) improves the rate of spleen rescue, yet the advantage of prophylactic SAE (pSAE) compared with surveillance and then embolization only if necessary (SURV) for patients at high risk of spleen rupture remains controversial.
Objective


To determine whether the 1-month spleen salvage rate is better after pSAE or SURV.
Design, Setting, and Participants


In this randomized clinical trial conducted between February 6, 2014, and September 1, 2017, at 16 institutions in France, 133 patients with splenic trauma at high risk of rupture were randomized to undergo pSAE or SURV. All analyses were performed on a per-protocol basis, as well as an intention-to-treat analysis for specific events.
Interventions


Prophylactic SAE, preferably using an arterial approach via the femoral artery, or SURV.
Main Outcomes and Measures


The primary end point was an intact spleen or a spleen with at least 50% vascularized parenchyma detected on an arterial computed tomography scan at 1 month after trauma, assessed by senior radiologists masked to the treatment group. Secondary end points included splenectomy and pseudoaneurysm, secondary SAE after inclusion, complications, length of hospital stay, quality-of-life score, and length of time off work or studies during the 6-month follow-up.
Results


A total of 140 patients were randomized, and 133 (105 men [78.9%]; median age, 30 years [interquartile range, 23-47 years]) were retained in the study. For the primary end point, data from 117 patients (57 who underwent pSAE and 60 who underwent SURV) could be analyzed. The number of patients with at least a 50% viable spleen detected on a computed tomography scan at month 1 was not significantly different between the pSAE and SURV groups (56 of 57 [98.2%] vs 56 of 60 [93.3%]; difference, 4.9%; 95% CI, -2.4% to 12.1%; P = .37). By the day 5 visit, there were significantly fewer splenic pseudoaneurysms among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 8 of 65 [12.3%]; difference, -10.8%; 95% CI, -19.3% to -2.1%; P = .03), significantly fewer secondary embolizations among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 19 of 65 [29.2%]; difference, -27.7%; 95% CI, -41.0% to -15.9%; P < .001), and no difference in the overall complication rate between the pSAE and SURV groups (19 of 65 [29.2%] vs 27 of 65 [41.5%]; difference, -12.3%; 95% CI, -28.3% to 4.4%; P = .14). Between the day 5 and month 1 visits, the overall complication rate was not significantly different between the pSAE and SURV groups (11 of 59 [18.6%] vs 12 of 63 [19.0%]; difference, -0.4%; 95% CI, -14.4% to 13.6%; P = .96). The median length of hospitalization was significantly shorter for patients in the pSAE group than for those in the SURV group (9 days [interquartile range, 6-14 days] vs 13 days [interquartile range, 9-17 days]; P = .002).
Conclusions and Relevance


Among patients with splenic trauma at high risk of rupture, the 1-month spleen salvage rate was not statistically different between patients undergoing pSAE compared with those receiving SURV. In view of the high proportion of patients in the SURV group needing SAE, both strategies appear defendable.
Trial Registration


ClinicalTrials.gov Identifier: NCT02021396.",2020,"By the day 5 visit, there were significantly fewer splenic pseudoaneurysms among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 8 of 65 [12.3%]; difference, -10.8%; 95% CI, -19.3% to -2.1%; P = .03), significantly fewer secondary embolizations among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 19 of 65 [29.2%]; difference, -27.7%; 95% CI, -41.0% to -15.9%; P < .001), and no difference in the overall complication rate between the pSAE and SURV groups (19 of 65 [29.2%] vs 27 of 65 [41.5%]; difference, -12.3%; 95% CI, -28.3% to 4.4%; P = .14).","['140 patients were randomized, and 133 (105 men [78.9%]; median age, 30 years [interquartile range, 23-47 years', '117 patients (57 who underwent pSAE and 60 who underwent SURV', 'patients with splenic trauma at high risk of rupture', 'Patients With Blunt Trauma at High Risk of Splenectomy', 'February 6, 2014, and September 1, 2017, at 16 institutions in France, 133 patients with splenic trauma at high risk of rupture']","['prophylactic SAE (pSAE', 'Prophylactic Embolization', 'pSAE or SURV', 'pSAE', 'Splenic arterial embolization (SAE']","['intact spleen or a spleen with at least 50% vascularized parenchyma detected on an arterial computed tomography scan', 'secondary embolizations', 'splenic pseudoaneurysms', 'median length of hospitalization', 'splenectomy and pseudoaneurysm, secondary SAE after inclusion, complications, length of hospital stay, quality-of-life score, and length of time off work or studies during the 6-month follow-up', 'spleen salvage rate', 'overall complication rate', 'computed tomography scan']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C3163695', 'cui_str': 'Transarterial embolization'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0042382', 'cui_str': 'Vascularized'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C1510412', 'cui_str': 'Pseudoaneurysm'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C3163695', 'cui_str': 'Transarterial embolization'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0585074', 'cui_str': 'Amount of time off work'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",140.0,0.40247,"By the day 5 visit, there were significantly fewer splenic pseudoaneurysms among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 8 of 65 [12.3%]; difference, -10.8%; 95% CI, -19.3% to -2.1%; P = .03), significantly fewer secondary embolizations among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 19 of 65 [29.2%]; difference, -27.7%; 95% CI, -41.0% to -15.9%; P < .001), and no difference in the overall complication rate between the pSAE and SURV groups (19 of 65 [29.2%] vs 27 of 65 [41.5%]; difference, -12.3%; 95% CI, -28.3% to 4.4%; P = .14).","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arvieux', 'Affiliation': 'Department of General and Digestive Surgery, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Frandon', 'Affiliation': 'Department of Imaging and Interventional Radiology, Nîmes University Hospital (CHU), Nîmes, France.'}, {'ForeName': 'Fatah', 'Initials': 'F', 'LastName': 'Tidadini', 'Affiliation': 'Department of General and Digestive Surgery, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Monnin-Bares', 'Affiliation': 'Department of Imaging and Interventional Radiology, Montpellier University Hospital (CHU), Montpellier, France.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Foote', 'Affiliation': 'Department of General and Digestive Surgery, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Dubuisson', 'Affiliation': 'Department of Vascular and General Surgery, Bordeaux University Hospital (CHU), Bordeaux, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Lermite', 'Affiliation': 'Department of Visceral Surgery, Angers University Hospital (CHU), Angers, France.'}, {'ForeName': 'Jean-Stéphane', 'Initials': 'JS', 'LastName': 'David', 'Affiliation': 'Department of Anesthesia and Intensive Care, Lyon-Sud University Hospital (CHU), Pierre Bénite, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Douane', 'Affiliation': 'Department of Imaging and Interventional Radiology, Nantes University Hospital (CHU), Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tresallet', 'Affiliation': 'Department of General, Digestive, Oncologic, Bariatric, and Metabolic Surgery, Avicenne University Hospital (CHU), Bobigny, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Lemoine', 'Affiliation': 'Department of General and Oncologic Surgery, Nîmes University Hospital (CHU), Nîmes, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Rodiere', 'Affiliation': 'Department of Imaging and Interventional Radiology, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bouzat', 'Affiliation': 'Department of Anesthesia and Intensive Care, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'Department of Medical Information, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Vilotitch', 'Affiliation': 'Department of Medical Information, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Barbois', 'Affiliation': 'Department of General and Digestive Surgery, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Thony', 'Affiliation': 'Department of Imaging and Interventional Radiology, Grenoble-Alpes University Hospital (CHU), Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.3672']
2813,32936297,Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials.,"Importance


Large placebo responses in randomized clinical trials may keep effective medication from reaching the market. Primary outcome measures of clinical trials have shifted from patient-reported to objective outcomes, partly because response to randomized placebo treatment is thought to be greater in subjective compared with objective outcomes. However, a direct comparison of placebo response in subjective and objective outcomes in the same patient population is missing.
Objective


To assess whether subjective patient-reported (pain severity) and objective inflammation (C-reactive protein [CRP] level and erythrocyte sedimentation rate [ESR]) outcomes differ in placebo response.
Design, Setting, and Participants


The placebo arms of 5 double-blind, randomized, placebo-controlled clinical trials were included in this cross-sectional study. These trials were conducted internationally for 24 weeks or longer between 2005 and 2009. All patients with rheumatoid arthritis randomized to placebo (N = 788) were included. Analysis of data from these trials was conducted from March 27 to December 31, 2019.
Intervention


Placebo injection.
Main Outcomes and Measures


The difference (with 95% CIs) from baseline at week 12 and week 24 on a 0- to 100-mm visual analog scale to evaluate the severity of pain, CRP level, and ESR.
Results


Of the 788 patients included in the analysis, 644 were women (82%); mean (SD) age was 51 (13) years. There was a statistically significant decrease in patient-reported pain intensity (week 12: -14 mm; 95% CI, -12 to -16 mm and week 24: -20 mm; 95% CI, -16 to -22 mm). Similarly, significant decreases were noted in the CRP level (week 12: -0.51 mg/dL; 95% CI, -0.47 to -0.56 mg/dL and week 24: -1.16 mg/dL; 95% CI, -1.03 to -1.30 mg/dL) and ESR (week 12: -11 mm/h; 95% CI, -10 to 12 mm/h and week 24: -25 mm/h; 95% CI, -12 to -26 mm/h) (all P < .001).
Conclusions and Relevance


The findings of this study suggest that improvements in clinical outcomes among participants randomized to placebo were not limited to subjective outcomes. Even if these findings could largely demonstrate a regression to the mean, they should be considered for future trial design, as unexpected favorable placebo responses may result in a well-designed trial becoming underpowered to detect the treatment difference needed in clinical drug development.",2020,There was a statistically significant decrease in patient-reported pain intensity (week 12:,"['All patients with rheumatoid arthritis randomized to', 'N\u2009=\u2009788) were included', '788 patients included in the analysis, 644 were women (82%); mean (SD) age was 51 (13) years']","['placebo', 'Placebo', 'Placebo injection']","['subjective patient-reported (pain severity) and objective inflammation (C-reactive protein [CRP', 'CRP level', 'patient-reported pain intensity', 'level and erythrocyte sedimentation rate [ESR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}]",644.0,0.664657,There was a statistically significant decrease in patient-reported pain intensity (week 12:,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vollert', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shiv T', 'Initials': 'ST', 'LastName': 'Sehra', 'Affiliation': 'Mount Auburn Hospital, Harvard Medical School, Cambridge, Massachusetts.'}, {'ForeName': 'Deirdre K', 'Initials': 'DK', 'LastName': 'Tobias', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA network open,['10.1001/jamanetworkopen.2020.13196']
2814,32936322,Dual-axis rotational coronary angiography versus conventional coronary angiography: a randomized comparison.,"BACKGROUND


Dual-axis of rotational coronary angiography (RA), with one single cine acquisition during continuous C-arm motion along a pre-described path, is an alternative to conventional coronary angiography (CA). We assessed the performance of RA versus CA in a modern, experienced cath lab setting.
METHODS


Sixty-seven patients with suspected coronary artery disease undergoing invasive coronary angiography were randomized to CA (n = 35) or dual-axis RA (n = 32). CA was performed with four left and two right coronary artery acquisitions with manual contrast medium injection. In RA, one cine acquisition each was performed for the left (5 projections) and right coronary artery (3 projections) with a fixed amount of contrast medium applied by a power injector. In both groups, single cine acquisitions in additional angulations were performed to fully interpret the coronary system, if necessary. Procedural parameters and outcome were compared.
RESULTS


Mean age was 63 ± 12 years (64% males). Six additional projections were required in the RA group compared to 13 in the CA group (p = 0.173). Fluoroscopy duration (CA: 3 ± 3 min, RA: 3 ± 2 min, p = 0.748) and dose area product (CA: 1291 ± 761 µGym 2 , RA: 1476 ± 679 µGym 2 , p = 0.235) did not differ significantly between both groups. For CA, the amount of contrast medium (42 ± 13 vs. 46 ± 8 ml, p = 0.022) and procedure time (8 ± 5 vs. 11 ± 3 min, p < 0.001) were significantly lower. No major adverse event occurred during hospital stay.
CONCLUSIONS


Dual-axis RA represents a feasible and safe alternative method to CA for obtaining coronary angiograms. However, no superiority was observed when performed by an experienced interventionalist with a modern system.",2020,Six additional projections were required in the RA group compared to 13 in the CA group (p = 0.173).,"['Mean age was 63\u2009±\u200912\xa0years (64% males', 'Sixty-seven patients with suspected coronary artery disease undergoing invasive coronary angiography']","['Dual-axis RA', 'Dual-axis rotational coronary angiography versus conventional coronary angiography', 'dual-axis RA', 'CA', 'rotational coronary angiography (RA']",['procedure time'],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",67.0,0.0162108,Six additional projections were required in the RA group compared to 13 in the CA group (p = 0.173).,"[{'ForeName': 'Michaela M', 'Initials': 'MM', 'LastName': 'Hell', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany. mmhell@gmx.de.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Gilg', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Röther', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Blachutzik', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schlundt', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01743-5']
2815,32936442,Soluble and insoluble fibers in ostrich nutrition: influences on growth performance and blood biochemical indices during different ages.,"This experiment was undertaken to evaluate the effects of different levels of soluble and insoluble fibers on growth performance and blood indices in ostrich at the age of 1 to 6 months. Thirty 30-day-old ostriches (males and females) were randomly assigned to five treatments with six replicates. There were five dietary treatments consisted of (1) basal diet; (2 and 3) diets containing 2 and 4% more soluble fibers (SF) than basal diet, and (4 and 5) diets containing 2 and 4% more insoluble fibers (ISF) than the basal diet. The dietary treatments had no significant influence on growth performance of ostriches. By increasing the levels of SF and ISF, the concentration of blood glucose (P < 0.0001) and high-density lipoprotein (HDL, P = 0.0046) increased, while the plasma concentration of triglyceride (P < 0.0001) and very-low-density lipoprotein (VLDL, P = 0.0006) decreased. The plasma enzyme activity of alanine aminotransferase (ALT) decreased in ostriches fed diet containing 4% more SF as compared with control (P < 0.0006). Body weight gain (BWG) at the starter phase (3-4 months) was higher than the pre-starter (1-2 months) and grower (5-6 months) phases (P < 0.0001). The highest concentration of blood glucose was observed at 2 months of age while the lowest magnitude was found at 4 months of age (P < 0.0001). The plasma cholesterol concentration increased at 4 months and decreased at 6 months as compared with 2 months (P < 0.0001). The concentration of HDL and LDL at 4 months of age was higher than two other ages (P < 0.0001). The blood concentration of triglyceride (P < 0.0001), VLDL (P < 0.0001), and ALT (P = 0.0005) decreased as ostriches grew up. It could be concluded that increasing the levels of soluble and insoluble fibers in the diet up to 4% more than previous recommendation may not have negative effects on growth performances and blood indices in ostrich.",2020,"The blood concentration of triglyceride (P < 0.0001), VLDL (P < 0.0001), and ALT (P = 0.0005) decreased as ostriches grew up.","['ostrich at the age of 1 to 6\xa0months', 'different ages', 'Thirty 30-day-old ostriches (males and females']","['basal diet; (2 and 3) diets containing 2 and 4% more soluble fibers (SF) than basal diet, and (4 and 5) diets containing 2 and 4% more insoluble fibers (ISF']","['highest concentration of blood glucose', 'blood concentration of triglyceride', 'plasma concentration of triglyceride', 'plasma enzyme activity of alanine aminotransferase (ALT', 'levels of SF and ISF, the concentration of blood glucose', 'Body weight gain (BWG', 'concentration of HDL and LDL', 'VLDL', 'growth performance and blood biochemical indices', 'growth performance of ostriches', 'high-density lipoprotein', 'plasma cholesterol concentration']","[{'cui': 'C0325336', 'cui_str': 'Struthio camelus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C3661726', 'cui_str': 'Insoluble fiber'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C3661726', 'cui_str': 'Insoluble fiber'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0325336', 'cui_str': 'Struthio camelus'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}]",,0.0308993,"The blood concentration of triglyceride (P < 0.0001), VLDL (P < 0.0001), and ALT (P = 0.0005) decreased as ostriches grew up.","[{'ForeName': 'Seyyed Mohammad', 'Initials': 'SM', 'LastName': 'Mirbehbahani', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran.'}, {'ForeName': 'Seyyed Javad', 'Initials': 'SJ', 'LastName': 'Hosseini-Vashan', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran. jhosseiniv@birjand.ac.ir.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mojtahedi', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran.'}, {'ForeName': 'Seyyed Homayoun', 'Initials': 'SH', 'LastName': 'Farhangfar', 'Affiliation': 'Department of Animal Science, College of Agriculture, University of Birjand, Amirabad Pardis, Birjand, South Khorasan, Islamic Republic of Iran.'}, {'ForeName': 'Seyyed Abdollah', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Animal Nutrition, Animal Science Research Institute, Karaj, Islamic Republic of Iran.'}]",Tropical animal health and production,['10.1007/s11250-020-02403-6']
2816,32936505,Will the patient's double eyelid shape be like that of the surgeon performing the procedure? A study of surgeons' aesthetics in East Asian Blepharoplasty.,"BACKGROUND


No reports of the potential areas of surgeons' aesthetics in blepharoplasty.
AIMS


To explore the association between the surgeons' own double eyelid morphology and their aesthetics and surgical outcome.
METHODS


An investigation of 1605 patients was carried collecting the data of double eyelid shape, based on which to propose a preliminary double eyelid classification for analyzing the aesthetics of surgeons. Ten double eyelid surgical cases were randomly collected from each surgeon according to the inclusion criteria, whose double eyelid shape, ideal shape, the selection tendency of surgical approach, most cared factor during surgery, and design concept of eyelid shape were collected. Structural equation modeling (SEM) was performed to assess the association between participants' double eyelid shape, aesthetics, and blepharoplasty outcome.
RESULTS


Fifty-three double eyelid surgeons were enrolled for study, whose double eyelids shapes mostly were obviously fan-shaped (37.74%) and low-parallel eyelid (26.42%), and the ideal shapes were obviously fan-shaped (41.51%) and high-parallel eyelid (24.53%). 54.72% of the subjects preferred to use the full-incisional method. 45.28% cared for long-term outcome most. Regarding blepharoplasty outcome style, 49.06% of the subjects preferred obviously fan-shaped type and 24.53% for high-parallel type. SEM showed that aesthetics rank increased by 0.692 points for surgeons' shape (P < .001), and surgical outcome rank increased by 0.861 points for aesthetics (P < .001). However, their eyelid shape had no direct contribution to surgical outcome (P = .96).
CONCLUSIONS


The findings indicated that surgeons' double eyelid shape positively affected their aesthetics, which affected their surgical outcomes further, but their double eyelid shape failed to affect the surgical outcomes directly.",2020,SEM showed that aesthetics rank increased by 0.692 points for surgeons' shape (P ,"[""surgeons' aesthetics in East Asian Blepharoplasty"", '1605 patients', 'Ten double eyelid surgical cases', 'Fifty-three double eyelid surgeons']",['Structural equation modeling (SEM'],"['aesthetics rank', 'surgical outcome rank']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0197213', 'cui_str': 'Repair of eyelid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}]","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1605.0,0.116942,SEM showed that aesthetics rank increased by 0.692 points for surgeons' shape (P ,"[{'ForeName': 'Hayson Chenyu', 'Initials': 'HC', 'LastName': 'Wang', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Wenyun', 'Initials': 'W', 'LastName': 'Ting', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Tong', 'Affiliation': 'HSBC Business School, Peking University, Beijing, China.'}, {'ForeName': 'Ruijia', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Long', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jiuzuo', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Hairu', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Tianyu Sun', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nanze', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Department of Plastic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13699']
2817,32936533,Bioequivalence and Pharmacokinetic Evaluation of Two Metformin Hydrochloride Tablets Under Fasting and Fed Conditions in Healthy Chinese Volunteers.,"This article aims to assess the bioequivalence of the test and the reference metformin hydrochloride tablets in healthy Chinese volunteers under fasting and fed conditions and to explore the effect of food on the pharmacokinetic (PK) profiles of both formulations. In total, 56 healthy Chinese subjects (28 in each group) were enrolled in this randomized, open, single-center, single-dose, 2-treatment, 2-sequence, 2-cycle cross clinical trial. The subjects were administrated a single dose of the test and the reference tablets at 0.25 g with a 7-day washout. Venous blood samples of all subjects were taken from predose 0 hour to postdose 24 hours according to the planned times. PK parameters for metformin were analyzed and calculated with noncompartmental methods. There were no significant differences in the PK parameters between the 2 formulations under both the fasting and the fed states. The 90% confidence intervals of 2 formulations were within 80.00%-125.00% based on C max  , AUC 0-t  , and AUC 0-∞  under both conditions. High-fat and high-calorie diets delayed the T max  and reduced the AUC 0-t  and AUC 0-∞  . No severe adverse events occurred in this study. Two metformin hydrochloride tablets were bioequivalent under both fasting and fed states; the high-fat and high-calorie diet could lower the rate and extent of absorption of metformin in healthy Chinese volunteers.",2020,High-fat and high-calorie diets delayed the T max  and reduced the AUC 0-t  and AUC 0-∞  .,"['Healthy Chinese Volunteers', 'healthy Chinese volunteers under fasting and fed conditions', '56 healthy Chinese subjects (28 in each group', 'healthy Chinese volunteers']","['metformin hydrochloride tablets', 'Metformin Hydrochloride Tablets', 'metformin hydrochloride']","['severe adverse events', 'Venous blood samples', 'PK parameters', 'rate and extent of absorption of metformin']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]",56.0,0.0227836,High-fat and high-calorie diets delayed the T max  and reduced the AUC 0-t  and AUC 0-∞  .,"[{'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Huang', 'Affiliation': 'Department of Phase I Clinical Trial Research Center, XiangYa BoAi Rehabilitation Hospital, Changsha, China.'}, {'ForeName': 'Gong-Zhu', 'Initials': 'GZ', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, the Second XiangYa Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Bin-Bin', 'Initials': 'BB', 'LastName': 'He', 'Affiliation': 'Changsha Ruiyi Medical\xa0Technology Co., Ltd., Changsha, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Department of Phase I Clinical Trial Research Center, XiangYa BoAi Rehabilitation Hospital, Changsha, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Long', 'Affiliation': 'Chongqing Kerui Pharmaceutical (Group) Co., Ltd., Chongqing, China.'}, {'ForeName': 'Bi-Kui', 'Initials': 'BK', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, the Second XiangYa Hospital of Central South University, Changsha, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.849']
2818,32936569,Irisin and inflammatory cytokines in elite male rowers: adaptation to volume-extended training period.,"AIM


This study examined the effect of 6-month volume-extended training period on irisin and inflammatory cytokine concentrations in elite male rowers.
METHODS


Nine elite male rowers (25.3±6.5 yrs; 190.6±5.1 cm; 93.4±7.5 kg; 14.6±2.6% body fat; maximal oxygen consumption [VO2max]: 64.0±3.5 ml.min.-1kg-1) participated in this study. Body composition, VO2max and blood biochemical markers were assessed before and after training period. Venous blood samples were analyzed for irisin, interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, vascular endothelial growth factor, interferon-γ, tumor necrosis factor-α, IL-1α, IL-1β, monocyte chemoattractant protein-1 and epidermal growth factor (EGF).
RESULTS


Average weekly training volume was significantly higher (P<0.05) during the 6 months of heavy training compared to relative rest (11.6±1.4 h.week-1 vs 18.4±1.0 h.week-1), while training intensity remained the same. At the end of training period, body fat% was significantly decreased, and fat free mass and maximal aerobic power significantly increased. Irisin was not changed (P>0.05) as the result of 6-month heavy training period, while training induced significant (P<0.05) increases and decreases in IL-10 and EGF values, respectively.
CONCLUSIONS


Serum irisin concentration was not sensitive to a significant increase in weekly training volume during the volume-extended training period in elite male rowers. An increase in training stress was accompanied by the increase in IL-10 and a decrease in EGF levels, and these inflammatory cytokines could be regarded as markers of heavy training stress during the typical preparatory period in elite male rowers.",2020,"At the end of training period, body fat% was significantly decreased, and fat free mass and maximal aerobic power significantly increased.","['elite male rowers', 'Nine elite male rowers (25.3±6.5 yrs; 190.6±5.1 cm; 93.4±7.5 kg; 14.6±2.6% body fat; maximal oxygen consumption [VO2max]: 64.0±3.5 ml.min.-1kg-1) participated in this study']","['heavy training', '6-month volume-extended training period']","['IL-10 and EGF values', 'Irisin and inflammatory cytokines', 'Venous blood samples', 'Irisin', 'fat free mass and maximal aerobic power', 'irisin, interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, vascular endothelial growth factor, interferon-γ, tumor necrosis factor-α, IL-1α, IL-1β, monocyte chemoattractant protein-1 and epidermal growth factor (EGF', 'training stress', 'Body composition, VO2max and blood biochemical markers', 'EGF levels', 'irisin and inflammatory cytokine concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",9.0,0.0224839,"At the end of training period, body fat% was significantly decreased, and fat free mass and maximal aerobic power significantly increased.","[{'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Jürimäe', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, Tartu, Estonia - jaak.jurimae@ut.ee.'}, {'ForeName': 'Priit', 'Initials': 'P', 'LastName': 'Purge', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11076-4']
2819,32931308,"Injection Therapy in Patients with Lateral Epicondylalgia: Hyaluronic Acid or Dextrose Prolotherapy? A Single-Blind, Randomized Clinical Trial.","Objective:  To compare the effects of hyaluronic acid (HA) and dextrose prolotherapy (DPT) injections in patients with chronic lateral epicondylalgia (LE).  Materials and Methods:  Thirty-two patients with at least 6 months of signs and symptoms of LE were randomly allocated into two groups: an HA group ( n  = 16) and a DPT group ( n  = 16). HA injection was performed as a single dose of 30 mg/2 mL 1500 kDa high-molecular-weight preparation (baseline). DPT injection was administered with 15% dextrose solution in three doses (baseline, third week, and sixth week). Severity of pain using the visual analog scale score, grip strength with a hand dynamometer, and physical function as determined by the Quick-Disabilities of the Arm, Shoulder, and Hand (Q-DASH) score were determined.  Results:  DPT was favored over HA for improvements from 0 to 12 weeks for pain with activity (4.81 ± 1.2 vs. 3.18 ± 2.3;  p  = 0.04), pain at night (5.1 ± 1.9 vs. 4.1 ± 2.2;  p  = 0.03), and pain at rest (3.8 ± 2.09 vs. 2.7 ± 1.7;  p  = 0.04). Q-DASH scores improved significantly more from 0 to 12 weeks in the DPT group (43.5 ± 17.6 vs. 28.4 ± 13.4;  p  = 0.04). No between-group improvement was observed for grip pain (7.3 ± 6.4 vs. 4.8 ± 3.2;  p  = 0.38).  Conclusions:  HA and DPT injections were both effective in reducing pain and increasing grip strength and function in patients with chronic LE. DPT injection was more effective in the short term than HA injection, in terms of pain relief and functional outcome. The study was registered at ClinicalTrials.gov under the identifier number NCT04395417.",2020,Q-DASH scores improved significantly more from 0 to 12 weeks in the DPT group (43.5 ± 17.6 vs. 28.4 ± 13.4;  p  = 0.04).,"['Patients with Lateral Epicondylalgia', 'Thirty-two patients with at least 6 months of signs and symptoms of LE', 'patients with chronic lateral epicondylalgia (LE', 'patients with chronic LE']","['HA and DPT injections', 'DPT injection', 'hyaluronic acid (HA) and dextrose prolotherapy (DPT) injections', 'DPT']","['Severity of pain using the visual analog scale score, grip strength with a hand dynamometer, and physical function as determined by the Quick-Disabilities of the Arm, Shoulder, and Hand (Q-DASH) score', 'pain at night', 'pain and increasing grip strength and function', 'pain relief and functional outcome', 'pain', 'grip pain', 'Q-DASH scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0636923', 'cui_str': 'diphenylthiosulfinate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}]",32.0,0.104433,Q-DASH scores improved significantly more from 0 to 12 weeks in the DPT group (43.5 ± 17.6 vs. 28.4 ± 13.4;  p  = 0.04).,"[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Apaydin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Zilan', 'Initials': 'Z', 'LastName': 'Bazancir', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Zühal', 'Initials': 'Z', 'LastName': 'Altay', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Inonu University, Malatya, Turkey.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0188']
2820,32931320,"Retraction of:  Aceves-Martins M, Llauradó E, Tarro L, et al: A School-Based, Peer-Led, Social Marketing Intervention to Engage Spanish Adolescents in a Healthy Lifestyle (''We Are Cool''-Som la Pera Study): A Parallel Cluster Randomized Controlled Study [Child Obes 2017;13:300-313; doi: 10.1089/chi.2016.0216].",,2020,,"[""Engage Spanish Adolescents in a Healthy Lifestyle (''We Are Cool''-Som la Pera Study"", 'Child Obes 2017;13:300-313']",['Social Marketing Intervention'],[],"[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0037640', 'cui_str': 'Somalia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517707', 'cui_str': '313'}]","[{'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0292577,,[],Childhood obesity (Print),['10.1089/chi.2016.0216.retract']
2821,32931368,Pressure ulcer healing with an intensive nutrition intervention in an acute setting: a pilot randomised controlled trial.,"OBJECTIVE


To investigate the feasibility of recruitment, retention, intervention delivery and outcome measurement in a nutritional intervention to promote pressure ulcer healing in an acute setting.
METHOD


Some 50 tertiary hospital patients with stage II or greater pressure ulcer were randomised to receive either individualised nutritional care by a dietitian, including prescription of wound healing supplements; or standard nutritional care. Relevant nutritional and pressure ulcer (PU) parameters were collected at day 5, 10, 15, 22 and then weekly or until discharge.
RESULTS


The median length of hospital stay was 14 days (1-70) with 29 patients discharged by day 15. There were 24 patients discharged before their PU fully healed. Per cent change in valid PU area and score measures from baseline to day 15 were chosen for outcome data analysis to account for varying initial size and severity of the wound and length of stay. There was a larger percentage reduction in PU measures in the intervention group, but this was not statistically significant. Little difference was found in nutritional intake between the control and intervention groups indicating a requirement to focus on effective delivery of the intervention in future studies. Future studies in the acute setting need to account for length of stay and ideally follow patients until full healing.
CONCLUSION


Results indicate a positive association with nutrition intervention and PU healing and that a rigorously designed and adequately powered study is feasible.",2020,Little difference was found in nutritional intake between the control and intervention groups indicating a requirement to focus on effective delivery of the intervention in future studies.,"['24 patients discharged before their PU fully healed', '50 tertiary hospital patients with stage II or greater pressure ulcer']","['intensive nutrition intervention', 'individualised nutritional care by a dietitian, including prescription of wound healing supplements; or standard nutritional care', 'nutritional intervention']","['Pressure ulcer healing', 'median length of hospital stay', 'nutritional intake', 'Relevant nutritional and pressure ulcer (PU) parameters', 'PU measures']","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.0386307,Little difference was found in nutritional intake between the control and intervention groups indicating a requirement to focus on effective delivery of the intervention in future studies.,"[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Banks', 'Affiliation': ""Department of Nutrition & Dietetics, Royal Brisbane & Women's Hospital, Herston, QLD.""}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Ross', 'Affiliation': ""Department of Nutrition & Dietetics, Royal Brisbane & Women's Hospital, Herston, QLD.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': ""Department of Nutrition & Dietetics, Royal Brisbane & Women's Hospital, Herston, QLD.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mudge', 'Affiliation': ""Internal Medicine & Aged Care, Royal Brisbane & Women's Hospital, Herston, QLD.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stankiewicz', 'Affiliation': ""Centre for Research & Education in Nursing, Royal Brisbane & Women's Hospital, Herston, QLD.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dwyer', 'Affiliation': ""Department of Nutrition & Dietetics, Royal Brisbane & Women's Hospital, Herston, QLD.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': ""Skin Integrity Services Royal Brisbane & Women's Hospital, Herston, QLD.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': ""Skin Integrity Services Royal Brisbane & Women's Hospital, Herston, QLD.""}]",Journal of wound care,['10.12968/jowc.2020.29.Sup9a.S10']
2822,32931375,Transcranial Direct Current Stimulation (tDCS) Improves Back-Squat Performance in Intermediate Resistance-Training Men.,"Purpose : The purpose of this study was to evaluate the effects of anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) on muscle endurance in the back-squat exercise.  Methods : Eleven healthy males, intermediate in resistance training (RT), aged between 18 and 31 years (25.5 ± 4.4 years) were recruited. In the initial visits (1st and 2nd visits), participants performed a 1RM test to determine the load in the back-squat exercise. Following the two initials visits, participants attended the lab for the two experimental conditions (anodal tDCS and sham), which were completed a week apart, with sessions randomly counterbalanced. The stimulation was applied over the DLPFC for 20 minutes using a 2 mA current intensity. Immediately after the experimental conditions, participants completed three sets of maximum repetitions (80% of 1RM), with a 1-minute recovery interval between each set in the back-squat exercise. Muscle endurance was determined by the total number of repetitions and the number of repetitions in each set.  Results : The total number of repetitions was higher in the anodal tDCS condition compared to sham condition ( p  ≤ .0001). Moreover, the number of repetitions performed in the first set was higher for anodal tDCS condition than in the sham condition ( p  ≤ .01).  Conclusion : This study found improvement in back-squat exercise performance after the application of anodal tDCS. The effects of anodal tDCS applied over DLPFC may be a promising ergogenic resource on muscle endurance in the back-squat exercise.",2020,The total number of repetitions was higher in the anodal tDCS condition compared to sham condition ( p  ≤ .0001).,"['Eleven healthy males, intermediate in resistance training (RT), aged between 18 and 31\xa0years (25.5\xa0± 4.4\xa0years) were recruited', 'Intermediate Resistance-Training Men']","['Transcranial Direct Current Stimulation (tDCS', 'anodal tDCS']","['Muscle endurance', 'total number of repetitions and the number of repetitions in each set', 'back-squat exercise performance', 'anodal tDCS condition', 'total number of repetitions']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",11.0,0.0227967,The total number of repetitions was higher in the anodal tDCS condition compared to sham condition ( p  ≤ .0001).,"[{'ForeName': 'Lucas Antunes Faria', 'Initials': 'LAF', 'LastName': 'Vieira', 'Affiliation': 'Salgado de Oliveira University (UNIVERSO).'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Lattari', 'Affiliation': 'Salgado de Oliveira University (UNIVERSO).'}, {'ForeName': 'Marco Antônio', 'Initials': 'MA', 'LastName': 'de Jesus Abreu', 'Affiliation': 'Salgado de Oliveira University (UNIVERSO).'}, {'ForeName': 'Guilherme Moraes', 'Initials': 'GM', 'LastName': 'Rodrigues', 'Affiliation': 'Salgado de Oliveira University (UNIVERSO).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Viana', 'Affiliation': 'Augusto Mota University Center.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Machado', 'Affiliation': 'Salgado de Oliveira University (UNIVERSO).'}, {'ForeName': 'Bruno Ribeiro Ramalho', 'Initials': 'BRR', 'LastName': 'Oliveira', 'Affiliation': 'Rural Federal University of Rio de Janeiro (UFRRJ).'}, {'ForeName': 'Geraldo de Albuquerque', 'Initials': 'GA', 'LastName': 'Maranhão Neto', 'Affiliation': 'Salgado de Oliveira University (UNIVERSO).'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1815638']
2823,32931382,Learn to Turn: Does Spotting Foster Skill Acquisition in Pirouettes?,"Purpose : The spotting technique (i.e., independent head from torso movement) has been revealed as the single feature that differentiates highly skilled from less-skilled dancers. In the current intervention study, the potential of a specific spotting training in novice dancers for learning double pirouettes was tested.  Method : Novice dancers trained pirouettes in an experimental group and an active control group over a period of eight weeks by receiving either specific spotting instructions or technical instructions only. Pirouette performance was examined in a pretest, and a one-week-delayed retention test. In a further control test, effects of explicitly instructing how to perform the pirouettes (i.e., either with or without spotting) were investigated.  Results : Different than expected, in the retention test, only few participants from the experimental group showed the spotting technique. Moreover, the spotting group did not perform better than the control group. Rather, the balance measure revealed that, while the control group improved over learning, the experimental group remained at the baseline values and showed a slight advantage for orientation only. In the control test, all groups showed inferior performance as compared to the retention test.  Conclusion : In sum, the current findings show that-at least for beginners-the spotting technique is not suitable to be implemented in applied training settings. Moreover, in line with the expert performance approach, this study suggests to investigate the implementation of expert skills in applied training routines experimentally.",2020,"In the control test, all groups showed inferior performance as compared to the retention test.  ",[],['specific spotting training'],"['Pirouette performance', 'spotting technique']",[],"[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0132481,"In the control test, all groups showed inferior performance as compared to the retention test.  ","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Klostermann', 'Affiliation': 'University of Bern.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schärli', 'Affiliation': 'University of Bern.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Kunz', 'Affiliation': 'University of Bern.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'University of Bern.'}, {'ForeName': 'Ernst-Joachim', 'Initials': 'EJ', 'LastName': 'Hossner', 'Affiliation': 'University of Bern.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1813239']
2824,32931545,Follow-up of a Wuqinxi exercise at home programme to reduce pain and improve function for knee osteoarthritis in older people: a randomised controlled trial.,"BACKGROUND


Exercise therapy is a key intervention in the management of knee osteoarthritis (KOA) and recommended in international guidelines on KOA management. An effective home-exercise programme for frail older adults with KOA was successful in achieving high adherence. This randomised controlled trial was to compare the adherence to the exercise and lasting effects of follow-up 3 months.
METHODS


Sixty-eight participants in the original Wuqinxi (WQX) exercise study were community dwelling older adults (age = 70.95 ± 9.85 years) with KOA were categorised into 34 controls group, 34 WQX group adherers. The Western Ontario and Mc Master Universities Osteoarthritis Index questionnaire score (WOMAC) pain and Berg Balance Scale, Timed Up and Go Test, 6-min Walk Test, 30-s chair stand test, isokinetic muscle strength testing of knee flexion and extension measured at pre-test and post-test of the intervention period and follow-up for two groups.
RESULTS


The WQX group maintained or improved in all nine measures from post-test to follow-up, whereas the control group significantly declined in WOMAC pain, Knee extensor strength and Knee flexor strength.
CONCLUSION


The WQX programme was an effective home-exercise programme that achieves high adherence in older adults with KOA who lived in these communities.",2020,The WQX programme was an effective home-exercise programme that achieves high adherence in older adults with KOA who lived in these communities.,"['Sixty-eight participants in the original Wuqinxi (WQX) exercise study were community dwelling older adults (age\u2009=\u200970.95\u2009±\u20099.85\xa0years) with KOA were categorised into 34 controls group, 34 WQX group adherers', 'frail older adults with KOA', 'older people', 'older adults with KOA who lived in these communities']","['WQX', 'Exercise therapy', 'Wuqinxi exercise']","['Western Ontario and Mc Master Universities Osteoarthritis Index questionnaire score (WOMAC) pain and Berg Balance Scale, Timed Up and Go Test, 6-min Walk Test, 30-s chair stand test, isokinetic muscle strength testing of knee flexion and extension', 'WOMAC pain, Knee extensor strength and Knee flexor strength']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",68.0,0.0535659,The WQX programme was an effective home-exercise programme that achieves high adherence in older adults with KOA who lived in these communities.,"[{'ForeName': 'Chun Mei', 'Initials': 'CM', 'LastName': 'Xiao', 'Affiliation': 'Department of Health Promotion and Physical Education, Beijing Institute of Graphic Communication, Beijing 102600, China.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Foreign Language Teaching, Beijing Institute of Graphic Communication, Beijing 102600, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Health Promotion and Physical Education, Beijing University Of Chemical Technology, Beijing 100029, China.'}, {'ForeName': 'Yong Chang', 'Initials': 'YC', 'LastName': 'Zhuang', 'Affiliation': 'Department of Wushu, Beijing Sport University, Beijing 100084, China.'}]",Age and ageing,['10.1093/ageing/afaa179']
2825,32931612,The Effects of Antioxidant Vitamins on Proinflammatory Cytokines and Some Biochemical Parameters of Power Plant Workers: A Double-Blind Randomized Controlled Clinical Trial.,"Some epidemiological studies have suggested that exposure to extremely low-frequency magnetic fields (ELF-MFs) can affect the immune system. This study aimed to investigate the effects of antioxidant vitamin consumption on proinflammatory cytokines and biochemical parameters changes. In this randomized, controlled double-blinded trial study, power plant workers exposed to ELF-MFs were enrolled based on inclusion criteria. Ninety-one eligible subjects were randomly divided into four groups: the first group (400 units of vitamin E/day), second group (1,000 mg of vitamin C/day), third group (400 units of vitamin E and 1,000 mg of vitamin C/day), and control group. The intervention was conducted for 3 months. Proinflammatory cytokines interleukin-1β (IL-1β), IL-6, and tumor necrosis factor-α (TNF-α), and biochemical parameters (fasting blood sugar, total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-c], total protein, and albumin) were measured among the participants' serums, before and after the intervention. The mean level of IL-6 in all vitamin-receiving groups, the mean level of IL-1β in vitamin C and E&C groups, and the mean level of TNF-α in the vitamin C group, decreased significantly after intervention. The arithmetic means of the effect sizes for IL-1β, IL-6, and TNF-α were 0.71, 0.57, and 0.2, respectively. The level of HDL-c in the vitamin E and vitamin E&C groups and the level of triglyceride in the vitamin C group significantly increased after the intervention. Taking antioxidant vitamins can prevent an increase of proinflammatory cytokines induced by prolonged exposure to ELF-MFs. Bioelectromagnetics. © 2020 Bioelectromagnetics Society.",2020,"The mean level of IL-6 in all vitamin-receiving groups, the mean level of IL-1β in vitamin C and E&C groups, and the mean level of TNF-α in the vitamin C group, decreased significantly after intervention.","['power plant workers exposed to ELF-MFs were enrolled based on inclusion criteria', 'Power Plant Workers', 'Ninety-one eligible subjects']","['antioxidant vitamin consumption', 'Antioxidant Vitamins', 'Taking antioxidant vitamins', 'vitamin E/day), second group (1,000\u2009mg of vitamin C/day), third group (400 units of vitamin E and 1,000\u2009mg of vitamin C/day), and control group']","['mean level of TNF-α', 'level of triglyceride', 'proinflammatory cytokines', 'mean level of IL-6', 'level of HDL-c', 'IL-1β, IL-6, and TNF-α', 'Proinflammatory Cytokines', 'Proinflammatory cytokines interleukin-1β (IL-1β), IL-6, and tumor necrosis factor-α (TNF-α), and biochemical parameters (fasting blood sugar, total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-c], total protein, and albumin']","[{'cui': 'C0032864', 'cui_str': 'Power Plants'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]",91.0,0.28242,"The mean level of IL-6 in all vitamin-receiving groups, the mean level of IL-1β in vitamin C and E&C groups, and the mean level of TNF-α in the vitamin C group, decreased significantly after intervention.","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Bagheri Hosseinabadi', 'Affiliation': 'School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Khanjani', 'Affiliation': 'Environmental Health Engineering Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Pirasteh', 'Initials': 'P', 'LastName': 'Norouzi', 'Affiliation': 'School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Faghihi-Zarandi', 'Affiliation': 'Department of Occupational Health Engineering, Modelling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Darban-Sarokhalil', 'Affiliation': 'Department of Microbiology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Sajjad', 'Initials': 'SS', 'LastName': 'Khoramrooz', 'Affiliation': 'Cellular and Molecular Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mirbadie', 'Affiliation': 'School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Mirzaii', 'Affiliation': 'School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}]",Bioelectromagnetics,['10.1002/bem.22294']
2826,32931641,"Effect of different limb lengths on quality of life, eating patterns and gastrointestinal symptoms after Roux-en-Y gastric bypass in superobese patients: randomized study.","BACKGROUND


Distal Roux-en-Y gastrojejunal bypass (DRYGJB) gives better weight reduction than standard Roux-en-Y gastric bypass (RYGB) but at the risk of increased malnutrition side-effects. This study compared the effects of RYGB and DRYGJB on gastrointestinal symptoms, eating patterns and health-related quality of life (QoL).
METHODS


This was a single-blind RCT from a university-affiliated obesity centre. Patients with a BMI of 50 kg/m 2  or above were invited to participate. Treatment arms were standard gastric bypass with an alimentary limb of 150 cm and a biliopancreatic limb of 60 cm, with a variable common channel length, or DRYGJB with biliopancreatic limb of 200 cm, common channel limb of 150 cm and variable alimentary limb length. Baseline and follow-up data to 5 years on quality of life, obesity-related problems and gastrointestinal symptoms were collected using prospectively created and validated questionnaires.
RESULTS


Some 140 patients were included. Those with a DRYGJB had better weight loss at 5 years (mean(s.d.) 68·3(21·8) kg versus 55·7(19·8) kg for standard RYGB; P = 0·011). Eating patterns improved, with no difference between the groups. Gastrointestinal symptoms (diarrhoea, indigestion) worsened significantly in both groups, but only patients with DRYGJB had significantly worse diarrhoea at the end of the study than at baseline (P = 0·006). Both groups had improved perceived generic QoL over baseline, and obesity-related problems were markedly reduced.
CONCLUSION


Standard RYGB and both improved generic and disease-specific QoL and eating behavioural pattern. Diarrhoea was increased more following DRYGJB than after RYGB. Registration number: NCT01514799 (https://clinicaltrials.gov).",2020,"Gastrointestinal symptoms (diarrhoea, indigestion) worsened significantly in both groups, but only patients with DRYGJB had significantly worse diarrhoea at the end of the study than at baseline (P = 0·006).","['university-affiliated obesity centre', 'Patients with a BMI of 50\u2009kg/m 2  or above were invited to participate', 'superobese patients', '140 patients were included']","['Roux-en-Y gastric bypass', 'standard Roux-en-Y gastric bypass (RYGB', 'Distal Roux-en-Y gastrojejunal bypass (DRYGJB', 'limb lengths', 'standard gastric bypass with an alimentary limb of 150\u2009cm and a biliopancreatic limb of 60\u2009cm, with a variable common channel length, or DRYGJB with biliopancreatic limb of 200\u2009cm, common channel limb of 150\u2009cm and variable alimentary limb length']","['weight loss', 'gastrointestinal symptoms, eating patterns and health-related quality of life (QoL', 'Eating patterns', 'diarrhoea', 'generic QoL over baseline, and obesity-related problems', 'Gastrointestinal symptoms (diarrhoea, indigestion', 'quality of life, eating patterns and gastrointestinal symptoms', 'generic and disease-specific QoL and eating behavioural pattern', 'quality of life, obesity-related problems and gastrointestinal symptoms', 'Diarrhoea']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1261315', 'cui_str': 'Limb length'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0392339', 'cui_str': 'Eating routine'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",140.0,0.0807542,"Gastrointestinal symptoms (diarrhoea, indigestion) worsened significantly in both groups, but only patients with DRYGJB had significantly worse diarrhoea at the end of the study than at baseline (P = 0·006).","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Nergård', 'Affiliation': 'Aleris Obesity Skåne, Malmö-Kristianstad, Lund, Sweden.'}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Leifson', 'Affiliation': 'Aleris Obesity Skåne, Malmö-Kristianstad, Lund, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gislason', 'Affiliation': 'Aleris Obesity Skåne, Malmö-Kristianstad, Lund, Sweden.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Hedenbro', 'Affiliation': 'Aleris Obesity Skåne, Malmö-Kristianstad, Lund, Sweden.'}]",BJS open,['10.1002/bjs5.50334']
2827,32931645,Usability and experience testing to refine an online intervention to prevent weight gain in new kidney transplant recipients.,"OBJECTIVES


Weight gain in the first year following kidney transplantation increases the risk of adverse health outcomes. Currently, there is no recognized intervention available to prevent weight gain after kidney transplantation. An online kidney transplant-specific resource, entitled Exercise in Renal Transplant Online (ExeRTiOn), has been co-created by a multi-professional team, including patients, to assist with weight prevention. This study aimed to evaluate patient and health care professional usability and experience of the ExeRTiOn online resource.
DESIGN


Qualitative study utilizing 'Think-Aloud' and semi-structured interviews.
METHODS


Participants (n = 17) were purposively sampled to include new kidney transplant recipients (n = 11) and transplant health care professionals (n = 6). Kidney transplant recipient participants were from a spread of physical activity levels based on scores from the General Practice Physical Activity Questionnaire (GPPAQ). 'Think-Aloud' interviews assessed the usability of ExeRTiOn. Semi-structured interviews explored participants' experience of ExeRTiOn, weight gain, and physical activity. The data set were analysed thematically. Participant characteristics, including login data and self-reported body weight, were collected.
RESULTS


Data analyses identified valued intervention content and usability aspects which were summarized by two themes. The first theme 'You need to know how to manage yourself' included subthemes: (1) the resource filled a guidance gap, (2) expert patient content resonated, and (3) the importance of goal setting and monitoring progress. The second theme 'room for improvement' included subthemes: (2) web support and (2) content and operational change suggestions.
CONCLUSIONS


Results have allowed for identification of potential areas for resource refinement. This has facilitated iterative enhancement of ExeRTiOn in preparation for a randomized controlled feasibility trial.",2020,"An online kidney transplant-specific resource, entitled Exercise in Renal Transplant Online","['Participants (n\xa0', '17) were purposively sampled to include new kidney transplant recipients (n\xa0=\xa011) and transplant health care professionals (n\xa0=\xa06', 'new kidney transplant recipients', 'Kidney transplant recipient participants', 'Renal Transplant Online']",['online intervention'],"['ExeRTiOn, weight gain, and physical activity', 'weight gain', 'usability of ExeRTiOn', 'General Practice Physical Activity Questionnaire (GPPAQ). ', 'subthemes: (2) web support and (2) content and operational change suggestions']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]",17.0,0.0361238,"An online kidney transplant-specific resource, entitled Exercise in Renal Transplant Online","[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Castle', 'Affiliation': ""Therapies Department, King's College Hospital, NHS Trust, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Greenwood', 'Affiliation': 'Victor Horsley Department of Neurosurgery, University College London Hospital, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chilcot', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Greenwood', 'Affiliation': ""Therapies Department, King's College Hospital, NHS Trust, UK.""}]",British journal of health psychology,['10.1111/bjhp.12471']
2828,32938633,Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial.,"OBJECTIVE


To investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.
DESIGN


Cluster randomised controlled trial.
SETTING


47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018.
PARTICIPANTS


In each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years.
INTERVENTIONS


Opportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks.
MAIN OUTCOME MEASURES


Difference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices.
RESULTS


Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found.
CONCLUSIONS


Opportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting.
TRIAL REGISTRATION


Netherlands Trial Register No NL4776 (old NTR4914).",2020,"RESULTS


Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices.","['9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years', '9526 patients were eligible for screening, 54.3% women, mean age 75.0 years', '47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018', '8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices', '266 patients who continued with Holter monitoring', 'In each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected', '9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol']","['Opportunistic screening versus usual care', 'three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device', 'Opportunistic screening']","['diagnosed atrial fibrillation', 'atrial fibrillation', 'diagnoses of atrial fibrillation', 'detection rate of newly diagnosed atrial fibrillation', 'detection rate of atrial fibrillation', 'new diagnoses of atrial fibrillation', 'detection of atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0422389', 'cui_str': 'Opportunistic screening'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}]",9526.0,0.151619,"RESULTS


Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices.","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Uittenbogaart', 'Affiliation': 'Department of General Practice, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, 9 Meibergdreef, PO Box 22660, 1100 DD Amsterdam, Netherlands s.b.uittenbogaart@amsterdamumc.nl.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Verbiest-van Gurp', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'Wim A M', 'Initials': 'WAM', 'LastName': 'Lucassen', 'Affiliation': 'Department of General Practice, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, 9 Meibergdreef, PO Box 22660, 1100 DD Amsterdam, Netherlands.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research, Utrecht, Netherlands.'}, {'ForeName': 'Petra M G', 'Initials': 'PMG', 'LastName': 'Erkens', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'J André', 'Initials': 'JA', 'LastName': 'Knottnerus', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'Henk C P M', 'Initials': 'HCPM', 'LastName': 'van Weert', 'Affiliation': 'Department of General Practice, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, 9 Meibergdreef, PO Box 22660, 1100 DD Amsterdam, Netherlands.'}, {'ForeName': 'Henri E J H', 'Initials': 'HEJH', 'LastName': 'Stoffers', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3208']
2829,32938723,LION-PAW (lymphadenectomy in ovarian neoplasm) sexual function assessment: a prospective sub-study of the LION trial.,"BACKGROUND


There is limited information about the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer.
OBJECTIVE


To evaluate the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer as a sub-protocol of the prospectively randomized LION trial.
METHODS


The Sexual Activity Questionnaire was applied to assess sexual function according to its sub-scales activity, pleasure, and discomfort. The 'orgasm' sub-scale from the Female Sexual Function Index was also added. The questionnaire was administered in combination with the EORTC QLQ-C30 questionnaire at baseline prior surgery, after 6, 12, and 24 months. The primary endpoint was changes in sexual function.
RESULTS


Overall, 495 patients received the questionnaires. 254 (51%) responded at baseline. Of these, 55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available. There was a total of 55/495 (11%) patients at 6 months, 139 (28%) patients at 12 months, and 81 (16%) patients at 24 months. Median age was 60.5 years (range 21.4-75.8). At baseline, sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years) and tended to have a better performance status. Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this. The orgasm sub-scale showed diverging results with a deterioration from baseline to 12 months in the lymphadenectomy group compared with the no-lymphadenectomy group (p=0.02).
CONCLUSION


The majority of patients were sexually inactive; however, in those who were sexually active, pain during intercourse was worse at 12 months. In addition, the orgasm sub-scale demonstrated worse results in patients who underwent complete lymphadenectomy. The study suggests that surgery in the retroperitoneal space may influence sexual function.",2020,"Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this.","['patients with advanced ovarian cancer', ""55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available"", 'Median age was 60.5 years (range 21.4-75.8', '495 patients received the questionnaires', 'sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years']","['radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy', 'LION-PAW (lymphadenectomy']","['sexual function', 'sexual function according to its sub-scales activity, pleasure, and discomfort', 'Discomfort evaluated as dryness of the vagina and pain during sexual intercourse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0023756', 'cui_str': 'Panthera leo'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",,0.0418331,"Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this.","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Center, Mainz, Germany Annette.Hasenburg@unimedizin-mainz.de.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynecology with Center for Oncological Surgery, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, New Hampshire, USA.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Lampe', 'Affiliation': 'Department of Gynecology and Obstetrics, Kaiserswerther Diakonie, Duesseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': 'Coordinating Centre for Clinical Trials, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeld', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ludwig-Maximilians-University Munich, München, Bayern, Germany.'}, {'ForeName': 'Antje Kristina', 'Initials': 'AK', 'LastName': 'Belau', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Bossart', 'Affiliation': 'Department of Gynecology and Obstetrics, University Medical Center Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': 'Department of Gynecology and Obstetrics, Medizinische Hochschule, Hannover, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Petry', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Wolfsburg, Wolfsburg, Niedersachsen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, KEM, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Herwig', 'Affiliation': 'Department of Gynecology and Obstetrics, Albertinen-Hospital Hamburg, Hamburg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'Department of Gynecology and Obstetrics, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gropp-Meier', 'Affiliation': 'Department of Gynecology and Obstetrics, St. Elisabethenhospital, Ravensburg, Baden-Württemberg, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Hanf', 'Affiliation': 'Department of Gynecology and Obstetrics, Klinikum Fürth, Fürth, Bayern, Germany.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Greimel', 'Affiliation': 'Clinical Psychology Unit, Medical University Graz, Graz, Steiermark, Austria.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Wagner', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Gießen and Marburg GmbH Site Marburg, Marburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, KEM, Kliniken Essen Mitte, Essen, Germany.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001551']
2830,32938772,Premature permanent discontinuation of apixaban or warfarin in patients with atrial fibrillation.,"AIMS


The ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial randomised patients with atrial fibrillation at risk of stroke to apixaban or warfarin. We sought to describe patients from ARISTOTLE who prematurely permanently discontinued study drug.
METHODS/RESULTS


We performed a posthoc analysis of patients from ARISTOTLE who prematurely permanently discontinued study drug during the study or follow-up period. Discontinuation rates and reasons for discontinuation were described. Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation. A total of 4063/18 140 (22.4%) patients discontinued study drug at a median of 7.3 (2.2, 15.2) months after randomisation. Patients with discontinuation were more likely to be female and had a higher prevalence of cardiovascular disease, diabetes, renal impairment and anaemia. Premature permanent discontinuation was more common in those randomised to warfarin than apixaban (23.4% vs 21.4%; p=0.002). The most common reasons for discontinuation were patient request (46.1%) and adverse event (34.9%), with no significant difference between treatment groups. The cumulative incidence of clinical events ≤30 days after premature permanent discontinuation for all-cause death, thromboembolism, myocardial infarction, and major bleeding was 5.8%, 2.6%, 0.9%, and 3.0%, respectively. No significant difference was seen between treatment groups with respect to clinical outcomes after discontinuation.
CONCLUSION


Premature permanent discontinuation of study drug in ARISTOTLE was common, less frequent in patients receiving apixaban than warfarin and was followed by high 30-day rates of death, thromboembolism and major bleeding. Initiatives are needed to reduce discontinuation of oral anticoagulation.",2020,"Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation.","['patients from ARISTOTLE who prematurely permanently discontinued study drug during the study or follow-up period', 'patients from ARISTOTLE who prematurely permanently discontinued study drug', 'A total of 4063/18 140 (22.4%) patients discontinued study drug at a median of 7.3 (2.2, 15.2) months after randomisation', 'patients with atrial fibrillation', 'Atrial Fibrillation) trial randomised patients with atrial fibrillation at risk of stroke to apixaban or warfarin']","['warfarin', 'apixaban or warfarin']","['Discontinuation rates and reasons for discontinuation', 'Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates', 'cardiovascular disease, diabetes, renal impairment and anaemia', '30-day rates of death, thromboembolism and major bleeding', 'Premature permanent discontinuation', 'death, thromboembolism, myocardial infarction, and major bleeding', 'adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.100854,"Death, thromboembolism (stroke, transient ischaemic attack, systemic embolism), myocardial infarction and major bleeding rates were stratified by ≤30 days or >30 days after discontinuation.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Carnicelli', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College, Bangalore, Karnataka, India.""}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Dalgaard', 'Affiliation': 'Cardiology, Gentofte Hospital, Hellerup, Hovedstaden, Denmark.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davies Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Bristol-Myers Squibb Pharmaceutical Research and Development, Princeton, New Jersey, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Uppsala Clinical Research Center, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA christopher.granger@duke.edu.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-317229']
2831,32938866,Cost-effectiveness analysis of prosthetic treatment with thermoplastic resin removable partial dentures.,"PURPOSE


The aim of this study was to compare the cost-effectiveness of thermoplastic resin removable partial dentures (TR-RPDs) with metal clasp-retained removable partial dentures (MC-RPDs), from the patients' perspective.
METHODS


Patient-reported outcome measures (Oral health-related quality of life [OHRQoL], patient satisfaction, oral appearance) were assessed among 24 partially dentate subjects who completed a randomized crossover trial comparing TR-RPDs and MC-RPDs. The prosthetic treatment fee for patients was used as the direct cost. The cost of achieving a clinically minimum important difference (MID) in Oral Health Impact Profile (OHIP) summary score, and the incremental cost-effectiveness ratio (ICE R) for each outcome measure were determined.
RESULTS


OHRQoL, patient satisfaction, and oral appearance was rated higher with TR-RPDs compared to MC-RPDs. The median cost of achieving a MID in OHRQoL with TR-RPDs ($698) was 6.5 times higher than that with MC-RPDs ($107). The ICER was $67 for the OHIP summary score, $195 for the satisfaction score, and $1,169 for the oral appearance rating.
CONCLUSIONS


Although TR-RPDs provide better OHRQoL, patient satisfaction, and oral appearance than MC-RPDs, the cost-effectiveness of TR-RPDs was inferior to MC-RPDs from the patients' perspective.",2020,"RESULTS


OHRQoL, patient satisfaction, and oral appearance was rated higher with TR-RPDs compared to MC-RPDs.",['thermoplastic resin removable partial dentures'],"['thermoplastic resin removable partial dentures (TR-RPDs) with metal clasp-retained removable partial dentures (MC-RPDs', 'TR-RPDs and MC-RPDs']","['cost-effectiveness', 'outcome measures (Oral health-related quality of life [OHRQoL], patient satisfaction, oral appearance', 'OHRQoL, patient satisfaction, and oral appearance', 'cost of achieving a clinically minimum important difference (MID) in Oral Health Impact Profile (OHIP) summary score, and the incremental cost-effectiveness ratio (ICE R', 'median cost of achieving a MID in OHRQoL with TR-RPDs', 'ICER']","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0333118', 'cui_str': 'Retained'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0011460', 'cui_str': 'Partial denture'}]",,0.0319806,"RESULTS


OHRQoL, patient satisfaction, and oral appearance was rated higher with TR-RPDs compared to MC-RPDs.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Fueki', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Inamochi', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Yoshida-Kohno', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Wakabayashi', 'Affiliation': 'Department of Removable Partial Prosthodontics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo.'}]",Journal of prosthodontic research,['10.2186/jpr.JPOR_2019_418']
2832,32939054,Prognostic and predictive significance of nuclear HIF1α expression in locally advanced HNSCC patients treated with chemoradiation with or without nimotuzumab.,"BACKGROUND


Anti-EGFR-based therapies have limited success in HNSCC patients. Predictive biomarkers are greatly needed to identify the patients likely to be benefited from these targeted therapies. Here, we present the prognostic and predictive association of biomarkers in HPV-negative locally advanced (LA) HNSCC patients.
METHODS


Treatment-naive tumour tissue samples of 404 patients, a subset of randomised Phase 3 trial comparing cisplatin radiation (CRT) versus nimotuzumab plus cisplatin radiation (NCRT) were analysed to evaluate the expression of HIF1α, EGFR and pEGFR by immunohistochemistry and EGFR gene copy change by FISH. Progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) were estimated by Kaplan-Meier method. Hazard ratios were estimated by Cox proportional hazard models.
RESULTS


Baseline characteristics of the patients were balanced between two treatment groups (CRT vs NCRT) and were representative of the trial cohort. The median follow-up was of 39.13 months. Low HIF1α was associated with better PFS [HR (95% CI) = 0.62 (0.42-0.93)], LRC [HR (95% CI) = 0.56 (0.37-0.86)] and OS [HR (95% CI) = 0.63 (0.43-0.93)] in the CRT group. Multivariable analysis revealed HIF1α as an independent negative prognostic biomarker. For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37-0.82), LRC:HR (95% CI) = 0.55 (0.36-0.85) and OS:HR (95% CI) = 0.54 (0.36-0.81)] compared to CRT. While in patients with low HIF1α, no difference in the clinical outcomes was observed between treatments. Interaction test suggested a predictive value of HIF1α for OS (P = 0.008).
CONCLUSIONS


High HIF1α expression is a predictor of poor clinical response to CRT in HPV-negative LA-HNSCC patients. These patients with high HIF1α significantly benefited with the addition of nimotuzumab to CRT.
CLINICAL TRIAL REGISTRATION


Registered with the Clinical Trial Registry of India (Trial registration identifier-CTRI/2014/09/004980).",2020,"For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37-0.82), LRC:HR (95% CI) = 0.55 (0.36-0.85) and OS:HR (95% CI) = 0.54 (0.36-0.81)] compared to CRT.","['locally advanced HNSCC patients treated with chemoradiation with or without nimotuzumab', 'HNSCC patients', 'HPV-negative locally advanced (LA) HNSCC patients', 'Treatment-naive tumour tissue samples of 404 patients']",['cisplatin radiation (CRT) versus nimotuzumab plus cisplatin radiation (NCRT'],"['expression of HIF1α, EGFR and pEGFR by immunohistochemistry and EGFR gene copy change by FISH', 'outcomes [PFS:HR', 'Progression-free survival (PFS), locoregional control (LRC) and overall survival (OS', 'Hazard ratios', 'clinical outcomes']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0242982', 'cui_str': 'c-erbB-1 Proto-Oncogenes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",404.0,0.254513,"For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37-0.82), LRC:HR (95% CI) = 0.55 (0.36-0.85) and OS:HR (95% CI) = 0.54 (0.36-0.81)] compared to CRT.","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Patel', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Pandey', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Tanuja A', 'Initials': 'TA', 'LastName': 'Samant', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Gera', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Mittal', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Rane', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Asawari', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vijay M', 'Initials': 'VM', 'LastName': 'Patil', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, Maharashtra, India.'}, {'ForeName': 'Manoj B', 'Initials': 'MB', 'LastName': 'Mahimkar', 'Affiliation': 'Mahimkar Lab, Cancer Research Institute, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, Maharashtra, India. mmahimkar@actrec.gov.in.'}]",British journal of cancer,['10.1038/s41416-020-01064-4']
2833,32939228,Waking Up from Dreamland: Opioid Addiction Precipitance and Support for Redistributive Drug Treatment.,"Motivated by the historical components of the ongoing U.S. opioid epidemic, this study examines how public support for redistributive drug treatment changes with awareness that someone's opioid addiction started with a legally acquired prescription. Using different versions of a vignette, we vary in a randomized design whether someone's addiction to painkillers started with a legally acquired prescription or with the decision to take pills from a friend. After reading the vignette, participants expressed their level of support for a policy that uses income redistribution to fund a program that provides the person in the vignette with drug treatment. We find that participants are less likely to support redistributive drug treatment when a prescription precipitates the addiction. The results imply that emphasizing the medical establishment's role in the opioid epidemic may actually make people less likely to favor using redistributive drug treatment to provide support.",2019,"After reading the vignette, participants expressed their level of support for a policy that uses income redistribution to fund a program that provides the person in the vignette with drug treatment.",[],[],[],[],[],[],,0.0312429,"After reading the vignette, participants expressed their level of support for a policy that uses income redistribution to fund a program that provides the person in the vignette with drug treatment.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chavanne', 'Affiliation': 'Department of Economics, Connecticut College, New London, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Goodyear', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Science, Brown University, Providence, RI, USA.'}]",Journal of drug policy analysis,['10.1515/jdpa-2019-0010']
2834,32939237,Effects of Lactose-Restricted Regimen in Breastfeeding Children with Acute Diarrhea.,"Background


Acute diarrhea is a major cause of mortality in children. Few studies have addressed the administration of lactose-restricted diets in breastfed children with acute diarrhea. The present study was conducted to investigate the effects of a lactose-restricted regimen on breastfed children with acute diarrhea treated with zinc supplements.
Methods


The present single-blind randomized clinical trial was conducted on children aged 6-24 months in Amirkola Children's Hospital (2015-2017). 90 children were randomly assigned to two groups. Group A was daily treated with 20 mg of zinc and a lactose-restricted diet and breast milk for two weeks. Group B received 20 mg of zinc and breast milk and an age-appropriate diet for two weeks. The data collected in all the subjects included the frequency of diarrhea and the mean duration of hospitalization and recovery from diarrhea.
Results


The two groups were not significantly different in terms of mean age, weight and ratio of males to females. The mean duration of hospitalization was found to be 3.1 ± 0.8 days in group A and 3.2 ± 0.6 in group B ( P  = 0.3), the mean duration of recovery to be 2.9 ± 0.8 in group A and 2.6 ± 1.1 in group B ( P  = 0.2) and the mean frequency of diarrhea 2.9 ± 0.7 in group A and 2.8 ± 0.8 days in group B ( P  = 0.5), suggesting no significant differences between the two groups. No adverse effects associated with zinc therapy were reported.
Conclusions


A lactose-restricted regimen was found not to be beneficial for children with acute diarrhea under continuous breastfeeding and zinc therapy.",2020,"Conclusions


A lactose-restricted regimen was found not to be beneficial for children with acute diarrhea under continuous breastfeeding and zinc therapy.","['Breastfeeding Children with Acute Diarrhea', 'breastfed children with acute diarrhea', 'breastfed children with acute diarrhea treated with zinc supplements', '90 children', 'children with acute diarrhea under continuous breastfeeding and zinc therapy', 'children', ""children aged 6-24 months in Amirkola Children's Hospital (2015-2017""]","['20 mg of zinc and breast milk and an age-appropriate diet', 'lactose-restricted regimen', '20 mg of zinc and a lactose-restricted diet and breast milk', 'Lactose-Restricted Regimen', 'lactose-restricted diets']","['mean age, weight and ratio of males to females', 'mean duration of recovery', 'frequency of diarrhea and the mean duration of hospitalization and recovery from diarrhea', 'mean duration of hospitalization', 'mean frequency of diarrhea']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",90.0,0.0271486,"Conclusions


A lactose-restricted regimen was found not to be beneficial for children with acute diarrhea under continuous breastfeeding and zinc therapy.","[{'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mehrabani', 'Affiliation': 'Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Esmaeili', 'Affiliation': 'Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Moslemi', 'Affiliation': 'Health Reproductive Research Center, Sari Branch, Islamic Azad University, Sari, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tarahomi', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_80_19']
2835,32939317,Bioavailability of oxycodone by mouth in coronary artery bypass surgery patients - a randomized trial.,"Objective


Pain after coronary artery by-pass (CAB) surgery is severe. Analgesic administration by mouth is unreliable until after gastrointestinal function has recovered. We evaluated the bioavailability of oxycodone co-administered with naloxone by mouth in patients after CAB surgery using either a conventional extracorporeal circulation (CECC) or off-pump surgery (OPCAB).
Methods


Twenty-four patients, 50-73 years, 12 with CECC and 12 with OPCAB, were administered a 10/5 mg oxycodone-naloxone controlled-release tablet by mouth on the preoperative day and for the first seven postoperative days (PODs) thereafter. Blood samples were collected up to 24 h after the preoperative administration, and then randomly either on POD1 and POD3 or on POD2 and POD4. The oxycodone concentration in plasma was analyzed using liquid chromatography-mass spectrometry.
Results


On POD1 oxycodone absorption was markedly delayed in five of six patients after CECC and in all six patients after OPCAB surgery; median of t max  after CECC 630 [range 270-1420] minutes and after OPCAB 1020 [720-1410] minutes, compared to median of 120-315 min preoperatively and on POD2-POD4. The carry-over corrected AUC 0-24  values on the PODs did not differ from the preoperative values, but were higher on POD3 compared with POD1 in both CECC and OPCAB groups. The rate and extent of oxycodone absorption equaled preoperative values on POD2 and onwards in patients with CAB surgery.
Conclusions


Bioavailability of oxycodone by mouth was similar after CAB surgery  via  CECC or having OPCAB. Data indicate that POD2 is an appropriate time to start oxycodone administration by mouth after CAB surgery.",2020,"On POD1 oxycodone absorption was markedly delayed in five of six patients after CECC and in all six patients after OPCAB surgery; median of t max  after CECC 630 [range 270-1420] minutes and after OPCAB 1020 [720-1410] minutes, compared to median of 120-315 min preoperatively and on POD2-POD4.","['coronary artery bypass surgery patients', 'patients after CAB surgery using either a', 'Methods\n\n\nTwenty-four patients, 50-73\u2009years, 12 with CECC and 12 with OPCAB', 'patients with CAB surgery']","['oxycodone co-administered with naloxone', 'conventional extracorporeal circulation (CECC) or off-pump surgery (OPCAB', 'coronary artery by-pass (CAB) surgery', 'oxycodone', 'oxycodone-naloxone']","['POD1 oxycodone absorption', 'Bioavailability']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0539362,"On POD1 oxycodone absorption was markedly delayed in five of six patients after CECC and in all six patients after OPCAB surgery; median of t max  after CECC 630 [range 270-1420] minutes and after OPCAB 1020 [720-1410] minutes, compared to median of 120-315 min preoperatively and on POD2-POD4.","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Valtola', 'Affiliation': 'Heart Centre, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Morse', 'Affiliation': 'Department of Pharmacology and Clinical Pharmacology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Florkiewicz', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hautajärvi', 'Affiliation': 'Admescope Ltd, Oulu, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Lahtinen', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Musialowicz', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Anesthesia, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Veli-Pekka', 'Initials': 'VP', 'LastName': 'Ranta', 'Affiliation': 'School of Pharmacy, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kokki', 'Affiliation': 'School of Medicine, University of Eastern Finland, Kuopio, Finland.'}]",Journal of drug assessment,['10.1080/21556660.2020.1797753']
2836,32939342,Treating subclinical and clinical symptoms of insomnia with a mindfulness-based smartphone application: A pilot study.,"Background/objectives


Emerging research suggests that face-to-face group mindfulness-based therapies are an effective intervention for insomnia. This pilot study examined the effectiveness of a mindfulness-based smartphone application for improving objectively-measured sleep, self-reported sleep, insomnia severity, pre-sleep arousal and daytime mood.
Method


A community sample of 23 adults with subclinical to moderately severe symptoms of insomnia were randomized to either a mindfulness or progressive muscle relaxation (PMR) smartphone application for 40 or 60 days. Objective sleep outcomes assessed using actigraphy, and self-report measures of total wake time, cognitive and somatic pre-sleep arousal, and daytime positive and negative affect were assessed for 14 nights at baseline and post-intervention. Insomnia severity was recorded at baseline and post-intervention.
Results


A greater reduction in sleep onset latency was observed in the mindfulness group over time, relative to the PMR group. The mindfulness group also reported medium effect size improvements for sleep efficiency. No significant interaction effects were found for self-reported sleep measures, however, main effects of time were found for both groups for total wake time, insomnia severity, cognitive pre-sleep arousal, and daytime positive and negative affect.
Conclusions


These preliminary findings suggest that both mindfulness and PMR smartphone applications have the potential to improve symptoms of insomnia. In particular, this mindfulness-based smartphone application may improve sleep onset latency and reduce the duration of night-awakenings. Further research exploring digital therapeutics as a self-help option for those with insomnia is needed.",2020,"A greater reduction in sleep onset latency was observed in the mindfulness group over time, relative to the PMR group.",['23 adults with subclinical to moderately severe symptoms of insomnia'],"['mindfulness-based smartphone application', 'mindfulness or progressive muscle relaxation (PMR) smartphone application']","['sleep efficiency', 'objectively-measured sleep, self-reported sleep, insomnia severity, pre-sleep arousal and daytime mood', 'total wake time, insomnia severity, cognitive pre-sleep arousal, and daytime positive and negative affect', 'duration of night-awakenings', 'sleep onset latency', 'Insomnia severity', 'Objective sleep outcomes assessed using actigraphy, and self-report measures of total wake time, cognitive and somatic pre-sleep arousal, and daytime positive and negative affect']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}]",23.0,0.013519,"A greater reduction in sleep onset latency was observed in the mindfulness group over time, relative to the PMR group.","[{'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Low', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Conduit', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Varma', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Meaklim', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Jackson', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia.'}]",Internet interventions,['10.1016/j.invent.2020.100335']
2837,32939556,"Glycine, a Dispensable Amino Acid, Is Conditionally Indispensable in Late Stages of Human Pregnancy.","BACKGROUND


Recently, we showed that there are higher protein, lysine, and phenylalanine requirements in late stages of pregnancy compared with early stages. Animal studies have suggested an increased dietary need for specific dispensable amino acids in pregnancy; whether such a need exists in human pregnancies is unknown.
OBJECTIVE


The objective of the current study was to examine whether healthy pregnant women at midgestation (20-29 wk) and late gestation (30-40 wk) have a dietary demand for glycine, a dispensable amino acid, using the indicator amino acid oxidation method and measurement of plasma 5-oxoproline concentrations.
METHODS


Seventeen healthy women (aged 26-36 y) randomly received different test glycine intakes (range: 5-100 mg·kg-1·d-1) during each study day in midgestation (∼26 wk, n = 17 observations in 9 women) and late gestation (∼35 wk, n = 19 observations in 8 women). Diets were isocaloric with energy at 1.7 × resting energy expenditure. Protein was given as a crystalline amino acid mixture based on egg protein composition at current estimated average requirement (EAR; 0.88 g·kg-1·d-1). Breath samples were collected at baseline and isotopic steady state to measure oxidation of L-[1-13C]phenylalanine to 13CO2 (F13CO2). Plasma was collected at the sixth hour of the study day. Linear regression crossover analysis and simple linear regression were used to assess responses in F13CO2 and plasma 5-oxoproline concentrations to different glycine intakes.
RESULTS


No statistically significant responses were observed in midgestation. However, in late gestation, lower glycine intakes resulted in higher rates of F13CO2 (suggesting low protein synthesis) with a breakpoint for phenylalanine oxidation at >37 mg glycine·kg-1·d-1 and higher plasma 5-oxoproline (suggesting low glycine availability) with a breakpoint >27 mg glycine·kg-1·d-1.
CONCLUSIONS


The findings suggest that glycine should be considered a ""conditionally"" indispensable amino acid during late gestation, especially when protein intakes are at 0.88 g·kg-1·d-1, the current EAR. This trial was registered at clinicaltrials.gov as NCT02149953.",2020,No statistically significant responses were observed in midgestation.,"['healthy pregnant women at midgestation (20-29 wk) and late gestation (30-40 wk', 'Seventeen healthy women (aged 26-36 y) randomly received']","['Glycine', 'different test glycine intakes', 'glycine']","['plasma 5-oxoproline', 'F13CO2 and plasma 5-oxoproline concentrations', 'Plasma']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0034330', 'cui_str': 'Pyrrolidonecarboxylic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",17.0,0.482536,No statistically significant responses were observed in midgestation.,"[{'ForeName': 'Betina F', 'Initials': 'BF', 'LastName': 'Rasmussen', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Madeleine A', 'Initials': 'MA', 'LastName': 'Ennis', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Dyer', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}]",The Journal of nutrition,['10.1093/jn/nxaa263']
2838,32931496,Biannual azithromycin distribution and child mortality among malnourished children: A subgroup analysis of the MORDOR cluster-randomized trial in Niger.,"BACKGROUND


Biannual azithromycin distribution has been shown to reduce child mortality as well as increase antimicrobial resistance. Targeting distributions to vulnerable subgroups such as malnourished children is one approach to reaching those at the highest risk of mortality while limiting selection for resistance. The objective of this analysis was to assess whether the effect of azithromycin on mortality differs by nutritional status.
METHODS AND FINDINGS


A large simple trial randomized communities in Niger to receive biannual distributions of azithromycin or placebo to children 1-59 months old over a 2-year timeframe. In exploratory subgroup analyses, the effect of azithromycin distribution on child mortality was assessed for underweight subgroups using weight-for-age Z-score (WAZ) thresholds of -2 and -3. Modification of the effect of azithromycin on mortality by underweight status was examined on the additive and multiplicative scale. Between December 2014 and August 2017, 27,222 children 1-11 months of age from 593 communities had weight measured at their first study visit. Overall, the average age among included children was 4.7 months (interquartile range [IQR] 3-6), 49.5% were female, 23% had a WAZ < -2, and 10% had a WAZ < -3. This analysis included 523 deaths in communities assigned to azithromycin and 661 deaths in communities assigned to placebo. The mortality rate was lower in communities assigned to azithromycin than placebo overall, with larger reductions among children with lower WAZ: -12.6 deaths per 1,000 person-years (95% CI -18.5 to -6.9, P < 0.001) overall, -17.0 (95% CI -28.0 to -7.0, P = 0.001) among children with WAZ < -2, and -25.6 (95% CI -42.6 to -9.6, P = 0.003) among children with WAZ < -3. No statistically significant evidence of effect modification was demonstrated by WAZ subgroup on either the additive or multiplicative scale (WAZ < -2, additive: 95% CI -6.4 to 16.8, P = 0.34; WAZ < -2, multiplicative: 95% CI 0.8 to 1.4, P = 0.50, WAZ < -3, additive: 95% CI -2.2 to 31.1, P = 0.14; WAZ < -3, multiplicative: 95% CI 0.9 to 1.7, P = 0.26). The estimated number of deaths averted with azithromycin was 388 (95% CI 214 to 574) overall, 116 (95% CI 48 to 192) among children with WAZ < -2, and 76 (95% CI 27 to 127) among children with WAZ < -3. Limitations include the availability of a single weight measurement on only the youngest children and the lack of power to detect small effect sizes with this rare outcome. Despite the trial's large size, formal tests for effect modification did not reach statistical significance at the 95% confidence level.
CONCLUSIONS


Although mortality rates were higher in the underweight subgroups, this study was unable to demonstrate that nutritional status modified the effect of biannual azithromycin distribution on mortality. Even if the effect were greater among underweight children, a nontargeted intervention would result in the greatest absolute number of deaths averted.
TRIAL REGISTRATION


The MORDOR trial is registered at clinicaltrials.gov NCT02047981.",2020,"Despite the trial's large size, formal tests for effect modification did not reach statistical significance at the 95% confidence level.
","['malnourished children', '523 deaths in communities assigned to', 'to children 1-59 months old over a 2-year timeframe', 'Between December 2014 and August 2017, 27,222 children 1-11 months of age from 593 communities had weight measured at their first study visit']","['azithromycin', 'placebo', 'azithromycin or placebo']","['antimicrobial resistance', 'child mortality', 'mortality rate', 'mortality rates']","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.296603,"Despite the trial's large size, formal tests for effect modification did not reach statistical significance at the 95% confidence level.
","[{'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Farouk', 'Initials': 'F', 'LastName': 'Manzo', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Alio K', 'Initials': 'AK', 'LastName': 'Mamkara', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Arnold', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, California, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003285']
2839,32931661,Analysis of chemotherapy effect on the second primary malignancy for head and neck cancer patients by a nomogram based on SEER database.,"Second primary malignancy (SPM) ranks the second leading cause of death in patients with head and neck cancer (HNC), while studies exploring the risk factors for SPM are limited. To clarify this, we investigated the relationship between the chemotherapy and SPM using the Surveillance, Epidemiology, and End Results (SEER) database. 11 345 patients initially diagnosed with HNC between 1998 and 2016 were selected from the SEER database. First, these patients were divided into two groups according to chemotherapy or not. With Fine and Gray model, the subdistribution hazard ratio (sHR) of chemotherapy was calculated based on Propensity Score Matching (PSM). Second, the 11 345 cases were randomized into a training set and a validation set. Based on the training set, the different cumulative incidence of SPMs between the patients with and without chemotherapy was estimated respectively in the high- and low-risk group according to the scores derived from a nomogram. Chemotherapy was negatively correlated to the SPMs (sHR: 0.847, 95% CI: 0.733-0.977, P = .023) by conducting competing risk analysis. With chemotherapy, forest plots showed subgroups of squamous cell carcinoma (SCC, sHR: 0.815, 95% CI: 0.7-0.948, P = .008), 50-64 years old (sHR:0.794, 95% CI: 0.655-0.962, P = .019), male (sHR:0.828, 95% CI: 0.703-0.974, P = .023), and well/moderate histological grade (sHR:0.828, 95% CI: 0.688-0.996, P = .045) were negatively correlated to SPMs; the nomogram showed the high-risk population characterized as SCC, elder age, male, and well/moderate histological grade also tended to have lower incidence of SPMs (sHR: 0.805, 95% CI: 0.669-0.969, P = .022). Despite HNC patients with characteristics of SCC, increased age, male, and well/moderate histological grade had higher risk of a SPM, they were also more likely to be benefitted from chemotherapy to avoid it.",2020,"With chemotherapy, forest plots showed subgroups of squamous cell carcinoma (SCC, sHR: 0.815, 95% CI: 0.7-0.948, P = .008), 50-64 years old (sHR:0.794, 95% CI: 0.655-0.962, P = .019), male (sHR:0.828, 95% CI: 0.703-0.974, P = .023), and well/moderate histological grade (sHR:0.828, 95% CI: 0.688-0.996, P = .045) were negatively correlated to SPMs; the nomogram showed the high-risk population characterized as SCC, elder age, male, and well/moderate histological grade also tended to have lower incidence of SPMs (sHR: 0.805, 95% CI: 0.669-0.969, P = .022).","['head and neck cancer patients by a nomogram based on SEER database', 'patients with head and neck cancer (HNC', '11\xa0345 cases', '11\xa0345 patients initially diagnosed with HNC between 1998 and 2016 were selected from the SEER database']",['Chemotherapy'],"['squamous cell carcinoma', 'cumulative incidence of SPMs', 'subdistribution hazard ratio (sHR) of chemotherapy', 'moderate histological grade', 'SPMs (sHR']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0456201', 'cui_str': 'Histological grades'}]",11345.0,0.0359098,"With chemotherapy, forest plots showed subgroups of squamous cell carcinoma (SCC, sHR: 0.815, 95% CI: 0.7-0.948, P = .008), 50-64 years old (sHR:0.794, 95% CI: 0.655-0.962, P = .019), male (sHR:0.828, 95% CI: 0.703-0.974, P = .023), and well/moderate histological grade (sHR:0.828, 95% CI: 0.688-0.996, P = .045) were negatively correlated to SPMs; the nomogram showed the high-risk population characterized as SCC, elder age, male, and well/moderate histological grade also tended to have lower incidence of SPMs (sHR: 0.805, 95% CI: 0.669-0.969, P = .022).","[{'ForeName': 'Xinrong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Kaibo', 'Initials': 'K', 'LastName': 'Guo', 'Affiliation': 'The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'The First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, P. R. China.'}]",Cancer medicine,['10.1002/cam4.3442']
2840,32931666,Hyperbaric oxygen therapy for COVID-19 patients with respiratory distress: treated cases versus propensity-matched controls.,"Objective


Given the high mortality and prolonged duration of mechanical ventilation of COVID-19 patients, we evaluated the safety and efficacy of hyperbaric oxygen for COVID-19 patients with respiratory distress.
Methods


This is a single-center clinical trial of COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020. Patients in this trial received hyperbaric oxygen therapy at 2.0 atmospheres of pressure in monoplace hyperbaric chambers for 90 minutes daily for a maximum of five total treatments. Controls were identified using propensity score matching among COVID-19 patients admitted during the same time period. Using competing-risks survival regression, we analyzed our primary outcome of inpatient mortality and secondary outcome of mechanical ventilation.
Results


We treated 20 COVID-19 patients with hyperbaric oxygen. Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14. Of these 20 patients, two (10%) were intubated and died, and none remain hospitalized. Among 60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation). Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046).
Conclusion


Though limited by its study design, our results demonstrate the safety of hyperbaric oxygen among COVID-19 patients and strongly suggests the need for a well-designed, multicenter randomized control trial.",2020,"Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046).
","['60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation', '20 COVID-19 patients with hyperbaric oxygen', 'COVID-19 patients with respiratory distress', 'COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020', 'COVID-19 patients', 'Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14']","['Hyperbaric oxygen therapy', 'hyperbaric oxygen therapy', 'hyperbaric oxygen']",['safety and efficacy'],"[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475211', 'cui_str': 'L'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0575499,"Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046).
","[{'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Gorenstein', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Castellano', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Slone', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gillette', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Alsamarraie', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Jacobson', 'Affiliation': 'NYU Long Island School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Wall', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Jordan L', 'Initials': 'JL', 'LastName': 'Swartz', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Jenica J S', 'Initials': 'JJS', 'LastName': 'McMullen', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Osorio', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Koziatek', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}]","Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc",[]
2841,32931667,Clinical efficacy of adjuvant therapy with hyperbaric oxygen in diabetic nephropathy.,"Background and objective


Diabetic kidney disease (DKD) is the most common microvascular chronic complication of diabetes mellitus. Hyperbaric oxygen (HBO2) therapy will increase the partial pressure of oxygen (PaO2) and may improve cell repair processes, which can lead to better renal function. The objective of this study was to quantify the efficacy of adjuvant HBO2 to increase the glomerular filtration rate and urinary albumin excretion in diabetic patients, as well as determine its effectiveness to modify the clinical course of DKD.
Materials and methods


An experimental study was performed on patients with stage 3 and 4 DKD. Twenty sessions of HBO2 or ambient air in a hyperbaric chamber were administered. Estimated glomerular filtration rate, urine albumin:creatinine ratio calculation and clinical stage stratification were made prior to and after HBO2 administration. A descriptive, inferential and clinical efficacy analysis was performed.
Results


Urinary albumin/creatinine (UACR) mean values prior to HBO2 were 1452.9 ± 644.3 mg/g and decreased to 876.1 ± 504.0 mg/g at the end of the study (p=0.06). The patients in the control group showed a UACR mean of 2784.5 ± 2128.6 mg/g and 2861.4 ± 2424.2 mg/g at baseline and at the end of the study, respectively (p=0.82). Patients in the experimental/HBO2 group showed an estimated GFR of 27.3 ± 9.5 mL/min /1.73m2 before HBO2, with a 34.4 ± 6.9 mL/min/1.73m2 after treatment (p=0.017); control group eGFR was 30.1 ± 9.2 mL/min/1.73m2, decreasing to 22.2 ± 6.8 mL/min/1.73m2 (p=0.004). Relative risk 0.00, relative risk reduction -100%, absolute risk reduction -71.4%, 95% CI (-104.9% to -38.0%), NNT 1, 95% CI (1 to 3).
Conclusions


Management with HBO2 for DKD was associated with decreased excretion urinary albumin, improved GFR and clinical stage of patients in stages 3 and 4 of kidney damage unlike those receiving ambient air..",2020,Urinary albumin/creatinine (UACR) mean values prior to HBO2 were 1452.9 ± 644.3 mg/g and decreased to 876.1 ± 504.0 mg/g at the end of the study (p=0.06).,"['diabetic patients', 'diabetic nephropathy', 'patients with stage 3 and 4 DKD']","['adjuvant HBO2', 'Hyperbaric oxygen (HBO2) therapy', 'hyperbaric oxygen']","['Urinary albumin/creatinine (UACR) mean values prior to HBO2', 'excretion urinary albumin', 'partial pressure of oxygen (PaO2', 'glomerular filtration rate and urinary albumin excretion', 'Estimated glomerular filtration rate, urine albumin:creatinine ratio calculation and clinical stage stratification']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}]",,0.0664044,Urinary albumin/creatinine (UACR) mean values prior to HBO2 were 1452.9 ± 644.3 mg/g and decreased to 876.1 ± 504.0 mg/g at the end of the study (p=0.06).,"[{'ForeName': 'Karime Guadalupe', 'Initials': 'KG', 'LastName': 'Cardenas Ureña', 'Affiliation': 'Department of Nephrology, Specialties Naval Hospital of Veracruz, Mexico.'}, {'ForeName': 'Julio César', 'Initials': 'JC', 'LastName': 'Ramírez Nava', 'Affiliation': 'Hospital Specialties Naval Veracruz, Mexico. CAP FRAG SSN MC N, Specialist in Hyperbaric and Underwater Medicine.'}, {'ForeName': 'Félix Guillermo', 'Initials': 'FG', 'LastName': 'Márquez Celedonio', 'Affiliation': 'Research Coordination, School of Health Sciences, Universidad del Valle de México Campus Veracruz, Mexico.'}, {'ForeName': 'Omar Israel', 'Initials': 'OI', 'LastName': 'Salas Nolasco', 'Affiliation': 'Department of Nephrology, Specialties Naval Hospital of Veracruz, Mexico.'}, {'ForeName': 'Josué Elí', 'Initials': 'JE', 'LastName': 'Villegas Domínguez', 'Affiliation': 'Graduate School of Naval Health, Hospital Specialties Naval Veracruz, Mexico / Faculty of Medicine ""Dr. Porfirio Sosa Zárate"", Universidad del Valle de México, Veracruz campus, Mexico.'}, {'ForeName': 'Celia Nohemí', 'Initials': 'CN', 'LastName': 'Crespo-Cortés', 'Affiliation': 'School of Health Sciences, Universidad del Valle de México, Veracruz Campus, Mexico.'}]","Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc",[]
2842,32931668,Long-term effects of hyperbaric oxygen therapy on visual acuity and retinopathy.,"Hyperbaric oxygen (HBO2) therapy is an adjunct treatment for diabetic foot ulcers. Since plausible mechanisms of action for this treatment include increased angiogenesis and high tissue oxygen concentrations, concerns about deterioration of retinopathy have been raised. The aim of this study was to evaluate the effects of HBO2 on visual acuity (VA) and retinopathy in patients with chronic diabetic foot ulcers during a two-year follow-up period. This is a randomized, single-center, double-blinded and placebo-controlled clinical trial evaluating the effects of HBO2 in patients with diabetes mellitus and chronic foot ulcers. All study participants underwent an ophthalmological examination before the first study treatment and then at three, six, 12 and 24 months. Fifty patients with a median age of 67 years were included. Visual acuity was similar between groups and did not change during the two-year observation period. No differences in retinopathy were seen between groups; neither were any differences found in numbers or areas of bleedings, hard exudates, microaneurysms or edemas, nor between groups or visits. New clinically significant macular edema was identified in four eyes in the HBO2 group and in three eyes in the placebo group. In this population of diabetic foot ulcer patients HBO2 seems to be neutral in an ophthalmological perspective. From a retinal point of view, we could not identify any indication of harmful effects of HBO2 on the microvascular bed in the placebo group.",2020,"No differences in retinopathy were seen between groups; neither were any differences found in numbers or areas of bleedings, hard exudates, microaneurysms or edemas, nor between groups or visits.","['patients with chronic diabetic foot ulcers during a two-year follow-up period', 'patients with diabetes mellitus and chronic foot ulcers', 'diabetic foot ulcers', 'Fifty patients with a median age of 67 years were included']","['placebo', 'hyperbaric oxygen therapy', 'Hyperbaric oxygen (HBO2) therapy', 'HBO2']","['visual acuity and retinopathy', 'numbers or areas of bleedings, hard exudates, microaneurysms or edemas', 'Visual acuity', 'macular edema', 'visual acuity (VA) and retinopathy', 'retinopathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085119', 'cui_str': 'Ulcer of foot'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0423410', 'cui_str': 'Retinal lipid deposits'}, {'cui': 'C0333101', 'cui_str': 'Microaneurysm'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}]",50.0,0.204639,"No differences in retinopathy were seen between groups; neither were any differences found in numbers or areas of bleedings, hard exudates, microaneurysms or edemas, nor between groups or visits.","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Sellman', 'Affiliation': 'Institution of Clinical Sciences in Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Katzman', 'Affiliation': 'Institution of Clinical Sciences in Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Andreasson', 'Affiliation': 'Institution of Clinical Sciences in Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lõndahl', 'Affiliation': 'Institution of Clinical Sciences in Lund, Lund University, Lund, Sweden.'}]","Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc",[]
2843,32931791,RF-EMF exposure effects on sleep - Age doesn't matter in men!,"BACKGROUND


Although there are several human experimental studies on short-term effects of radiofrequency electromagnetic fields (RF-EMF) on sleep, the role of effect modification by sex or age in this context has not yet been considered. In an earlier study, we observed sex differences in RF-EMF effects in elderly subjects. The present study investigated possible RF-EMF effect modifications by age in men.
METHODS


Data available for the present analysis come from three double-blind, randomized cross-over studies, in which effects of different RF-EMF exposure signals on sleep were investigated in young [sample 1: 25.3 (mean) ± 2.6 (SD) years; sample 2: 25.4 ± 2.6 years; n=30, respectively] and older (69.1 ± 5.5 years; n=30) healthy male volunteers. Studies comprised a screening/adaptation night followed by nine experimental nights at two-week intervals. RF-EMF exposure effect modifications by age were analysed for two different exposure signals (GSM900 at 2 W/kg, TETRA at 6 W/kg), each compared to a sham exposure. Polysomnography, during which the exposure signals were delivered by a head worn antenna, as well as sleep staging were performed according to the AASM standard. Four subjective and 30 objective sleep parameters were statistically analysed related to possible RF-EMF effects.
RESULTS


Comparisons of sleep parameters observed under sham exposure revealed highly pronounced physiological differences between young and elderly men. A consistent exposure effect in both age groups was found for a shorter latency to persistent sleep under TETRA exposure reflecting a sleep-promoting effect. Exposure effect modifications by age were observed for two of the four self-reported sleep parameters following GSM900 exposure and for arousals during REM sleep under TETRA exposure.
CONCLUSIONS


As effects of a short-term all-night RF-EMF exposure on sleep occurred only sporadically in young and elderly men, it seems that age doesn't matter in this respect. However, as long as there are no corresponding data from young healthy women that would allow a comparison with the data from elderly women, this assumption cannot be conclusively verified. Nevertheless, the present results are not indicative of any adverse health effects.",2020,"Exposure effect modifications by age were observed for two of the four self-reported sleep parameters following GSM900 exposure and for arousals during REM sleep under TETRA exposure.
","['young [sample 1: 25.3 (mean) ± 2.6 (SD) years; sample 2: 25.4 ± 2.6 years; n=30, respectively] and older (69.1 ± 5.5 years; n=30) healthy male volunteers', 'age in men', 'elderly subjects', 'young healthy women', 'young and elderly men', 'men']","['short-term all-night RF-EMF exposure', 'RF-EMF', 'radiofrequency electromagnetic fields (RF-EMF', 'RF-EMF exposure signals']","['RF-EMF effects', 'sleep']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.0249735,"Exposure effect modifications by age were observed for two of the four self-reported sleep parameters following GSM900 exposure and for arousals during REM sleep under TETRA exposure.
","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Sauter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}]",Environmental research,['10.1016/j.envres.2020.110173']
2844,32931821,A behaviour change intervention aimed at increasing physical activity improves clinical control in adults with asthma: a randomised controlled trial.,"BACKGROUND


Higher levels of physical activity have been associated with better asthma clinical control.
RESEARCH QUESTION


Does a behaviour change intervention aimed at increasing physical activity change asthma clinical control, physical activity, sedentary time, health-related quality of life (HRQoL) and anxiety and depression symptoms?
STUDY DESIGN


and methods: Single-blind randomised controlled trial in which participants were allocated to an intervention group (IG) or a control group (CG). Both groups received usual care and disease-specific education. Participants in the IG also underwent an 8-week behaviour change intervention aimed at increasing physical activity. Before and after the intervention period, measures were made of: asthma clinical control (Asthma Control Questionnaire [ACQ]), physical activity, sedentary time and sleep quality (Actigraph), HRQoL (Asthma Quality of Life Questionnaire) and anxiety and depression symptoms (Hospital Anxiety and Depression scale). Data on asthma exacerbations were recorded 12 months before and throughout the intervention period.
RESULTS


Fifty-one participants were included (CG=26; IG=25). On completion of the intervention period, compared to the CG, those in the IG demonstrated improvements in asthma control (mean difference [95% CI] in ACQ score -0.8 [-1.1 to -0.4]), in daily step count (3,605 [1,937 to 8,867] steps/day), in sleep efficiency (9.2 [-7.1 to 21.9%] and a reduction in sedentary time (-1.1 [-2.9 to -0.6] hours/day). No between-group difference in HRQoL was observed. The percentage of participants who exacerbated during the intervention period was 27% in the IG vs. 60% in the CG (p=0.04). The change in time spent in moderate-intensity physical activity was inversely associated with change in ACQ (r=-0.60). Compared with the CG, a higher percentage of participants in the IG reported a reduction in anxiety symptoms (43% vs. 0%; p<0.02).
INTERPRETATION


In adults with moderate to severe asthma, a comprehensive behaviour change intervention that increased physical activity also produced improvements in asthma clinical control, sedentary time, sleep quality and anxiety symptoms.
CLINICAL TRIAL REGISTRATION


Protocol registration and Results System, Clinical Trials.gov, NCT-03705702.",2020,"Does a behaviour change intervention aimed at increasing physical activity change asthma clinical control, physical activity, sedentary time, health-related quality of life (HRQoL) and anxiety and depression symptoms?
","['adults with moderate to severe asthma', 'and methods', 'adults with asthma']","['usual care and disease-specific education', 'intervention group (IG) or a control group (CG']","['asthma control', 'asthma clinical control (Asthma Control Questionnaire [ACQ]), physical activity, sedentary time and sleep quality (Actigraph), HRQoL (Asthma Quality of Life Questionnaire) and anxiety and depression symptoms (Hospital Anxiety and Depression scale', 'sleep efficiency', 'sedentary time', 'time spent in moderate-intensity physical activity', 'physical activity change asthma clinical control, physical activity, sedentary time, health-related quality of life (HRQoL) and anxiety and depression symptoms', 'anxiety symptoms', 'physical activity', 'ACQ score -0.8', 'HRQoL', 'asthma exacerbations', 'asthma clinical control, sedentary time, sleep quality and anxiety symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}]",51.0,0.0975462,"Does a behaviour change intervention aimed at increasing physical activity change asthma clinical control, physical activity, sedentary time, health-related quality of life (HRQoL) and anxiety and depression symptoms?
","[{'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Freitas', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Natalia Fp', 'Initials': 'NF', 'LastName': 'Passos', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Carvalho-Pinto', 'Affiliation': 'Pulmonary Division, Heart Institute (InCor), Clinics Hospital, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Milton A', 'Initials': 'MA', 'LastName': 'Martins', 'Affiliation': 'Department of Medicine, laboratory of Experimental Therapeutics, Medical School, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cavalheri', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, WA, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, WA, Australia; Institute for Respiratory Health, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Stelmach', 'Affiliation': 'Pulmonary Division, Heart Institute (InCor), Clinics Hospital, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Celso Rf', 'Initials': 'CR', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physical Therapy, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil. Electronic address: cscarval@usp.br.'}]",Chest,['10.1016/j.chest.2020.08.2113']
2845,32931919,The assertive cardiac care trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting.,"BACKGROUND


Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group.
METHODS/DESIGN


ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes.
DISCUSSION


ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.",2020,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","['people with severe mental illness (SMI', 'people with severe mental illness in the primary care setting']",['coproduced assertive cardiac care intervention'],"['absolute CVD risk (ACVDR', '5-year ACVDR', '6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12\u202fmonths']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.192142,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Chondros', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia.'}, {'ForeName': 'Yong Yi', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia; School of Public Health, The University of Queensland, Australia; Policy and Epidemiology Group, Queensland Centre for Mental Health Research, Australia.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Gunn', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, Australia; Camden and Islington NHS Foundation Trust, NW1OPE, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Castle', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayaram', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kenny', 'Affiliation': 'College of Science, Health and Engineering, La Trobe Rural Health School, Violet Vines Marshman Centre for Rural Health Research, La Trobe University, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Australia.'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Morgan', 'Affiliation': 'Neuropsychiatric Epidemiology Research Unit, School of Population and Global Health, University of Western Australia, Australia; Centre for Clinical Research in Neuropsychiatry, Division of Psychiatry, University of Western Australia, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'Department of Physiology, University of Melbourne, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Potiriadis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Konstancja', 'Initials': 'K', 'LastName': 'Densley', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Palmer', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia. Electronic address: v.palmer@unimelb.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106143']
2846,32931949,A Randomized Controlled Trial of NSAIDS or Exercise to Reduce Delayed Local Pain after Influenza Vaccination.,,2020,,[],['NSAIDS or Exercise'],['Delayed Local Pain'],[],"[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.334827,,"[{'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Housel', 'Affiliation': 'Defense Health Agency Immunization Healthcare Division South Atlantic Region Vaccine Safety Hub; Womack Army Medical Center, Fort Bragg, NC. Electronic address: Laurie.a.housel.civ@mail.mil.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Beltran', 'Affiliation': 'Department of Research Womack Army Medical Center, Fort Bragg, NC.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Spooner', 'Affiliation': 'Defense Health Agency Immunization Healthcare Division Public Health Division.'}, {'ForeName': 'Limone C', 'Initials': 'LC', 'LastName': 'Collins', 'Affiliation': 'Defense Health Agency Immunization Healthcare Division Public Health Division; Department of Medicine, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Ewing', 'Affiliation': 'Viral and Rickettsial Diseases Department, Naval Medical Research Center, Silver Spring, MD.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Viral and Rickettsial Diseases Department, Naval Medical Research Center, Silver Spring, MD.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'McClenathan', 'Affiliation': 'Defense Health Agency Immunization Healthcare Division South Atlantic Region Vaccine Safety Hub; Womack Army Medical Center, Fort Bragg, NC.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.058']
2847,32931950,Cell-based Functional IgE Assays are Superior to Conventional Allergy Tests for Shrimp Allergy Diagnosis.,"BACKGROUND


The diagnosis of shellfish allergy currently relies on patient history, skin prick test (SPT) and serum specific IgE (sIgE) quantification. These methods lack sufficient diagnostic accuracy, while the gold standard of oral food challenges are risky and burdensome. Markers of reactivity and severity of allergic reactions to shellfish will improve clinical care of these patients.
OBJECTIVES


This study compared the diagnostic performance of SPT, sIgE, basophil activation test (BAT) and IgE crosslinking-induced luciferase expression (EXiLE) test for shrimp allergy.
METHODS


Thirty-five subjects with documented history of shrimp allergic reactions were recruited and grouped according to results of double-blind placebo-controlled food challenge (DBPCFC). In addition to routine diagnostics, BAT (Flow CAST) and EXiLE test with shrimp extract and tropomyosin were performed.
RESULTS


15/35 subjects were shrimp-allergic with pruritus, urticaria and itchy mouth on DBPCFC while 20/35 were tolerant to shrimp. Tropomyosin only accounted for 53.3% of sensitization among subjects with challenge-proven shrimp allergy. BAT using shrimp extract as stimulant showed the highest AUC value (0.88), Youden index (0.81), likelihood ratio (14.73), odds ratio (104) and variable importance (4.27) when compared with other assays and tropomyosin diagnosis. Results of BAT significantly correlated with those of EXiLE (r=0.664, P<.0001).
CONCLUSION


BAT is a more accurate diagnostic marker for shrimp allergy than SPT and shrimp sIgE, while EXiLE test based on IgE-crosslinking assay is a good alternative to BAT. Tropomyosin may not be the most important shrimp allergen in Chinese, which warrants further investigation to search for other major allergens and diagnostic markers.",2020,"BAT using shrimp extract as stimulant showed the highest AUC value (0.88), Youden index (0.81), likelihood ratio (14.73), odds ratio (104) and variable importance (4.27) when compared with other assays and tropomyosin diagnosis.","['subjects with challenge-proven shrimp allergy', 'Thirty-five subjects with documented history of shrimp allergic reactions']","['BAT', 'placebo-controlled food challenge (DBPCFC']","['shrimp-allergic with pruritus, urticaria and itchy mouth on DBPCFC', 'diagnostic performance of SPT, sIgE, basophil activation test (BAT) and IgE crosslinking-induced luciferase expression (EXiLE) test', 'highest AUC value']","[{'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0457931', 'cui_str': 'Shrimp'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0457931', 'cui_str': 'Shrimp'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C0201781', 'cui_str': 'Activation test'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024075', 'cui_str': 'Luciferase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",35.0,0.0361927,"BAT using shrimp extract as stimulant showed the highest AUC value (0.88), Youden index (0.81), likelihood ratio (14.73), odds ratio (104) and variable importance (4.27) when compared with other assays and tropomyosin diagnosis.","[{'ForeName': 'Christine Y Y', 'Initials': 'CYY', 'LastName': 'Wai', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Nicki Y H', 'Initials': 'NYH', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Agnes S Y', 'Initials': 'ASY', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shum', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Patrick S C', 'Initials': 'PSC', 'LastName': 'Leung', 'Affiliation': 'Division of Rheumatology, Allergy and Clinical Immunology, University of California, Davis, California, USA.'}, {'ForeName': 'Ka Hou', 'Initials': 'KH', 'LastName': 'Chu', 'Affiliation': 'School of Life Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Yat Wah', 'Initials': 'YW', 'LastName': 'Kwan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Qun Ui', 'Initials': 'QU', 'LastName': 'Lee', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Joshua S C', 'Initials': 'JSC', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Ivan C S', 'Initials': 'ICS', 'LastName': 'Lam', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital and Yan Chai Hospital, Hong Kong.'}, {'ForeName': 'Pui Fung', 'Initials': 'PF', 'LastName': 'Li', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kary J Y', 'Initials': 'KJY', 'LastName': 'Xu', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Cheuk Yin', 'Initials': 'CY', 'LastName': 'Lam', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Jinlyu', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Allergy and Clinical Immunology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatology and Immunological Disease, Beijing Key Laboratory of Precision Medicine for Diagnosis and Treatment on Allergic Diseases, Beijing 100730, Beijing, People's Republic of China.""}, {'ForeName': 'Gary W K', 'Initials': 'GWK', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ting Fan', 'Initials': 'TF', 'LastName': 'Leung', 'Affiliation': 'Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong. Electronic address: tfleung@cuhk.edu.hk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.057']
2848,32932233,Changes in the Load-Velocity Profile Following Power- and Strength-Oriented Resistance-Training Programs.,"OBJECTIVE


To compare the short-term effect of power- and strength-oriented resistance-training programs on the individualized load-velocity profiles obtained during the squat (SQ) and bench-press (BP) exercises.
METHODS


Thirty physically active men (age = 23.4 [3.5] y; SQ 1-repetition maximum [1RM] = 126.5 [26.7] kg; BP 1RM = 81.6 [16.7] kg) were randomly assigned to a power- (exercises: countermovement jump and BP throw; sets per exercise: 4-6; repetitions per set: 5-6; load: 40% 1RM) or strength-training group (exercises: SQ and BP; sets per exercise: 4-6; repetitions per set: 2-8; load: 70%-90% 1RM). The training program lasted 4 wk (2 sessions/wk). The individualized load-velocity profiles (ie, velocity associated with the 30%-60%-90% 1RM) were assessed before and after training through an incremental loading test during the SQ and BP exercises.
RESULTS


The power-training group moderately increased the velocity associated with the full spectrum of % 1RM for the SQ (effect size [ES] range: 0.70 to 0.93) and with the 30% 1RM for the BP (ES: 0.67), while the strength-training group reported trivial/small changes across the load-velocity spectrum for both the SQ (ES range: 0.00 to 0.35) and BP (ES range: -0.06 to -0.33). The power-training group showed a higher increase in the mean velocity associated with all % 1RM compared with the strength-training group for both the SQ (ES range: 0.54 to 0.63) and BP (ES range: 0.25 to 0.53).
CONCLUSIONS


The individualized load-velocity profile (ie, velocity associated with different % 1RM) of lower-body and upper-body exercises can be modified after a 4-wk resistance-training program.",2020,"The power-training group showed a higher increase in the mean velocity associated with all % 1RM compared with the strength-training group for both the SQ (ES range: 0.54 to 0.63) and BP (ES range: 0.25 to 0.53).
","['Thirty physically active men (age', 'kg; BP 1RM = 81.6 [16.7]\xa0kg) were randomly assigned to a power', ' 23.4']","['exercises: countermovement jump and BP throw; sets per exercise: 4-6; repetitions per set: 5-6; load: 40% 1RM) or strength-training group (exercises: SQ and BP; sets per exercise: 4-6; repetitions per set: 2-8; load: 70%-90% 1RM', 'power- and strength-oriented resistance-training programs', 'squat (SQ) and bench-press (BP) exercises']","['mean velocity', 'trivial/small changes across the load-velocity spectrum']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517655', 'cui_str': '23.4'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0319106,"The power-training group showed a higher increase in the mean velocity associated with all % 1RM compared with the strength-training group for both the SQ (ES range: 0.54 to 0.63) and BP (ES range: 0.25 to 0.53).
","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': ''}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0840']
2849,32932234,Preexercise Cycling Protocol Alters Pacing Behavior in Competitive Time Trials.,"PURPOSE


The behavior of an opponent has been shown to alter pacing and performance. To advance our understanding of the impact of perceptual stimuli such as an opponent on pacing and performance, this study examined the effect of a preexercise cycling protocol on exercise regulation with and without an opponent.
METHODS


Twelve trained cyclists performed 4 experimental, self-paced 4-km time-trial conditions on an advanced cycle ergometer in a randomized, counterbalanced order. Participants started the time trial in rested state (RS) or performed a 10-min cycling protocol at 67% peak power output (CP) before the time trial. During the time trials, participants had to ride alone (NO) or against a virtual opponent (OP). The experimental conditions were (1) RS-NO, (2) RS-OP, (3) CP-NO, and (4) CP-OP. Repeated-measures analyses of variance (P < .05) were used to examine differences in pacing and performance in terms of power output.
RESULTS


A faster pace was adopted in the first kilometer during RS-OP (318 [72] W) compared with RS-NO (291 [81] W; P = .03), leading to an improved finishing time during RS-OP compared with RS-NO (P = .046). No differences in either pacing or performance were found between CP-NO and CP-OP.
CONCLUSIONS


The evoked response by the opponent to adopt a faster initial pace in the 4-km time trial disappeared when cyclists had to perform a preceding cycling protocol. The outcomes of this study highlight that perceived exertion alters the responsiveness to perceptual stimuli of cyclists during competition.",2020,"No differences in either pacing or performance were found between CP-NO and CP-OP.
","['Twelve trained cyclists performed 4 experimental', 'participants had to ride alone (NO) or against a virtual opponent (OP']","['self-paced 4-km time-trial conditions on an advanced cycle ergometer', 'Preexercise Cycling Protocol', 'preexercise cycling protocol']","['finishing time', 'RS-NO, (2)\xa0RS-OP, (3)\xa0CP', 'evoked response']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.0440921,"No differences in either pacing or performance were found between CP-NO and CP-OP.
","[{'ForeName': 'Marco J', 'Initials': 'MJ', 'LastName': 'Konings', 'Affiliation': ''}, {'ForeName': 'Florentina J', 'Initials': 'FJ', 'LastName': 'Hettinga', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0763']
2850,32932235,Postexercise Inflammasome Activation and IL-1β Production Mitigated by Flavonoid Supplementation in Cyclists.,"Inflammasomes are multiprotein signaling platforms of the innate immune system that detect markers of physiological stress and promote the maturation of caspase-1 and interleukin 1 beta (IL-1β), IL-18, and gasdermin D. This randomized, cross-over trial investigated the influence of 2-week mixed flavonoid (FLAV) versus placebo (PL) supplementation on inflammasome activation and IL-1β and IL-18 production after 75-km cycling in 22 cyclists (42 ± 1.7 years). Blood samples were collected before and after the 2-week supplementation, and then 0 hr, 1.5 hr, and 21 hr postexercise (176 ± 5.4 min, 73.4 ± 2.0 %VO2max). The supplement (678 mg FLAVs) included quercetin, green tea catechins, and bilberry anthocyanins. The pattern of change in the plasma levels of the inflammasome adaptor oligomer ASC (apoptosis-associated speck-like protein containing caspase recruitment domain) was different between the FLAV and PL trials, with the FLAV ASC levels 52% lower (Cohen's d = 1.06) than PL immediately following 75-km cycling (interaction effect, p = .012). The plasma IL-1β levels in FLAV were significantly lower than PL (23-42%; Cohen's d = 0.293-0.644) throughout 21 hr of recovery (interaction effect, p = .004). The change in plasma gasdermin D levels were lower immediately postexercise in FLAV versus PL (15% contrast, p = .023; Cohen's d = 0.450). The patterns of change in plasma IL-18 and IL-37 did not differ between the FLAV and PL trials (interaction effects, p = .388, .716, respectively). These data indicate that 2-week FLAV ingestion mitigated inflammasome activation, with a corresponding decrease in IL-1β release in cyclists after a 75-km cycling time trial. The data from this study support the strategy of ingesting high amounts of FLAV to mitigate postexercise inflammation.",2020,"The pattern of change in the plasma levels of the inflammasome adaptor oligomer ASC (apoptosis-associated speck-like protein containing caspase recruitment domain) was different between the FLAV and PL trials, with the FLAV ASC levels 52% lower (Cohen's d = 1.06) than PL immediately following 75-km cycling (interaction effect, p = .012).","['22 cyclists (42 ± 1.7\xa0years', 'Cyclists']","['Flavonoid Supplementation', '2-week mixed flavonoid (FLAV) versus placebo (PL) supplementation']","['FLAV ASC levels', 'plasma IL-1β levels in FLAV', 'inflammasome activation and IL-1β and IL-18 production', 'quercetin, green tea catechins, and bilberry anthocyanins', 'Postexercise Inflammasome Activation and IL-1β Production', 'plasma IL-18 and IL-37', 'IL-1β release', 'plasma gasdermin D levels']","[{'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C3710940', 'cui_str': 'STS protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2936529', 'cui_str': 'Inflammasome'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0453269', 'cui_str': 'Bilberry extract'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",,0.134789,"The pattern of change in the plasma levels of the inflammasome adaptor oligomer ASC (apoptosis-associated speck-like protein containing caspase recruitment domain) was different between the FLAV and PL trials, with the FLAV ASC levels 52% lower (Cohen's d = 1.06) than PL immediately following 75-km cycling (interaction effect, p = .012).","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Nieman', 'Affiliation': 'Appalachian State University.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': 'NC State University.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pecorelli', 'Affiliation': 'NC State University.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Woodby', 'Affiliation': 'NC State University.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hoyle', 'Affiliation': 'Appalachian State University.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simonson', 'Affiliation': 'Appalachian State University.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Valacchi', 'Affiliation': 'NC State University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0084']
2851,32932273,Shave Excision Versus Elliptical Excision of Nonpigmented Intradermal Melanocytic Nevi: Comparative Assessment of Recurrence and Cosmetic Outcomes.,"BACKGROUND


Nonpigmented intradermal melanocytic nevi (IMN) are benign lesions often removed for cosmetic reasons. There is no consensus as to the best technique for IMN excision.
OBJECTIVE


To compare cosmetic outcomes and risk of recurrence after shave excision versus elliptical excision of IMN.
MATERIALS AND METHODS


In this randomized clinical trial, patients underwent shave excision or elliptical excision with sutured closure of IMN of the face or back. Recurrence, patient satisfaction, cosmetic outcome, postoperative discomfort, scar size, discoloration, and presence of hypertrophic or keloid scars were evaluated at 3, 6, and 9 months.
RESULTS


Overall, 145 nevi were removed from 45 patients (86.7% women, mean age 52.1 ± 12.5 years). The recurrence rate was 11.7%, occurring only after shave excision; 94.1% of recurrences were observed at 3-month follow-up. Shave excision was associated with less discomfort 48 hours after intervention but a greater likelihood of involved lateral and deep margins (p < .001). Scars were larger after elliptical excision and suture than after shave excision (p < .01). The mean patient satisfaction was higher in the shave excision group (p < .004).
CONCLUSION


Shave excision of IMN is associated with higher rates of involved surgical margins and recurrence than elliptical excision but provides superior cosmesis and patient satisfaction.",2020,Shave excision of IMN is associated with higher rates of involved surgical margins and recurrence than elliptical excision but provides superior cosmesis and patient satisfaction.,"['145 nevi were removed from 45 patients (86.7% women, mean age 52.1 ± 12.5 years']","['shave excision or elliptical excision with sutured closure of IMN of the face or back', 'intradermal melanocytic nevi (IMN', 'Shave Excision Versus Elliptical Excision of Nonpigmented Intradermal Melanocytic Nevi', 'shave excision versus elliptical excision of IMN']","['recurrence rate', 'Recurrence, patient satisfaction, cosmetic outcome, postoperative discomfort, scar size, discoloration, and presence of hypertrophic or keloid scars', 'mean patient satisfaction']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0027960', 'cui_str': 'Nevi'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0567344', 'cui_str': 'Shave excision'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0027962', 'cui_str': 'Melanocytic nevus'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",145.0,0.0280356,Shave excision of IMN is associated with higher rates of involved surgical margins and recurrence than elliptical excision but provides superior cosmesis and patient satisfaction.,"[{'ForeName': 'Leandra', 'Initials': 'L', 'LastName': 'Camini', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Ana Paula Dornelles', 'Initials': 'APD', 'LastName': 'Manzoni', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Magda Blessmann', 'Initials': 'MB', 'LastName': 'Weber', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luzzato', 'Affiliation': 'Department of Dermatology, Universidade Federal de Ciências da Saúde Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Andréa Santos', 'Initials': 'AS', 'LastName': 'Soares', 'Affiliation': 'Dermatologist in Private Practice, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Renan Rangel', 'Initials': 'RR', 'LastName': 'Bonamigo', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Universidade Federal de do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, Brazil.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002666']
2852,32940679,Effect of Outpatient Rehabilitation on Functional Mobility After Single Total Knee Arthroplasty: A Randomized Clinical Trial.,"Importance


Even without evidence, rehabilitation practitioners continue to introduce new interventions to enhance the mobility outcomes for the increasing population with a recent total knee arthroplasty (TKA).
Objective


To compare post-TKA functional mobility outcomes among 3 newly developed physical therapy protocols with a standard-of-care post-TKA rehabilitation protocol.
Design, Setting, and Participants


This randomized clinical trial included 4 study arms implemented in 15 outpatient clinics within a single health system in the Baltimore, Maryland, and Washington, District of Columbia, region from October 2013 to April 2017. Participants included patients who underwent elective unilateral TKA, were aged 40 years and older, and began outpatient physical therapy within 24 days after TKA. A total of 505 patients were screened and 386 participants were enrolled. Patients provided informed consent and were randomly assigned to 1 of 4 groups. Blinding patients and treating therapists was not feasible owing to the nature of the intervention. Analysis was conducted under the modified intent-to-treat principle from October 2017 to May 2019.
Interventions


The control group used a standard recumbent bike for 15 to 20 minutes each session. Interventions used 1 of 3 modalities for 15 to 20 minutes each session: (1) a body weight-adjustable treadmill, (2) a patterned electrical neuromuscular stimulation device, or (3) a combination of the treadmill and electrical neuromuscular stimulation.
Main Outcomes and Measures


Outcomes included the Activity Measure for Post-acute Care basic mobility score, a patient-reported outcome measure, and the 6-minute walk test. Outcomes were measured at baseline, monthly, and on discharge from outpatient therapy.
Results


Data from 363 patients (mean [SD] age, 63.4 [7.9] years; 222 [61.2%] women) were included in the final analysis, including 92 participants randomized to the control group, 91 participants randomized to the treadmill group, 90 participants randomized to the neuromuscular stimulation device group, and 90 participants randomized to the combination intervention group. Activity Measure for Post-acute Care scores at discharge were similar across groups, ranging from 61.1 to 61.3 (P = .99) with at least 9.0 points improvement (P = .80) since baseline. The distances as measured by the 6-minute walking test were not statistically different across groups (range, 382.9-404.5 m; P = .60).
Conclusions and Relevance


This randomized clinical trial found no statistically or clinically significant differences in outcomes across the 4 arms. Because outcomes were similar among arms, clinicians should instead consider relative cost in tailoring TKA rehabilitation.
Trial Registration


ClinicalTrials.gov Identifier: NCT02426190.",2020,"The distances as measured by the 6-minute walking test were not statistically different across groups (range, 382.9-404.5 m; P = .60).
","['Participants included patients who underwent elective unilateral TKA, were aged 40 years and older, and began outpatient physical therapy within 24 days after TKA', '363 patients (mean [SD] age, 63.4 [7.9] years; 222 [61.2%] women', '15 outpatient clinics within a single health system in the Baltimore, Maryland, and Washington, District of Columbia, region from October 2013 to April 2017', 'A total of 505 patients were screened and 386 participants were enrolled', 'After Single Total Knee Arthroplasty', '3 newly developed physical therapy protocols with a standard-of-care post-TKA rehabilitation protocol']","['body weight-adjustable treadmill, (2) a patterned electrical neuromuscular stimulation device, or (3) a combination of the treadmill and electrical neuromuscular stimulation', 'Outpatient Rehabilitation', 'neuromuscular stimulation device']","['Activity Measure for Post-acute Care basic mobility score, a patient-reported outcome measure, and the 6-minute walk test', 'Functional Mobility', 'Activity Measure for Post-acute Care scores', '6-minute walking test']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0012764', 'cui_str': 'District of Columbia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0454448', 'cui_str': 'Neuromuscular stimulation'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376635', 'cui_str': 'Postacute Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",505.0,0.176095,"The distances as measured by the 6-minute walking test were not statistically different across groups (range, 382.9-404.5 m; P = .60).
","[{'ForeName': 'Chinghui Jean', 'Initials': 'CJ', 'LastName': 'Hsieh', 'Affiliation': 'Agency for Healthcare Research and Quality, Department of Health and Human Services, Rockville, Maryland.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'DeJong', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, District of Columbia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Vita', 'Affiliation': 'MedStar National Rehabilitation Network, Washington, District of Columbia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zeymo', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, Maryland.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Desale', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16571']
2853,32940689,Circulating Tumor DNA Markers for Early Progression on Fulvestrant With or Without Palbociclib in ER+ Advanced Breast Cancer.,"BACKGROUND


There are no established molecular biomarkers for patients with breast cancer receiving combination endocrine and CDK4/6 inhibitor (CDK4/6i). We aimed to determine whether genomic markers in circulating tumor DNA (ctDNA) can identify patients at higher risk of early progression on fulvestrant therapy with or without palbociclib, a CDK4/6i.
METHODS


PALOMA-3 was a phase III, multicenter, double-blind randomized controlled trial of palbociclib plus fulvestrant (n = 347) vs placebo plus fulvestrant (n = 174) in patients with endocrine-pretreated estrogen receptor-positive (ER+) breast cancer. Pretreatment plasma samples from 459 patients were analyzed for mutations in 17 genes, copy number in 14 genes, and circulating tumor fraction. Progression-free survival (PFS) was compared in patients with circulating tumor fraction above or below a prespecified cutoff of 10% and with or without a specific genomic alteration. All statistical tests were 2-sided.
RESULTS


Patients with high ctDNA fraction had worse PFS on both palbociclib plus fulvestrant (hazard ratio [HR] = 1.62, 95% confidence interval [CI] = 1.17 to 2.24; P = .004) and placebo plus fulvestrant (HR = 1.77, 95% CI = 1.21 to 2.59; P = .004). In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001). No interaction with treatment randomization was observed.
CONCLUSIONS


Pretreatment ctDNA identified a group of high-risk patients with poor clinical outcome despite the addition of CDK4/6 inhibition. These patients might benefit from inclusion in future trials of escalating treatment, with therapies that may be active in these genomic contexts.",2020,"In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001).","['ER+ Advanced Breast Cancer', 'patients with breast cancer receiving combination endocrine and CDK4/6 inhibitor (CDK4/6i', 'patients with endocrine-pretreated estrogen receptor-positive (ER+) breast cancer', 'patients at higher risk of early progression on fulvestrant therapy with or without palbociclib, a CDK4/6i', '459 patients were analyzed for mutations in 17 genes, copy number in 14 genes, and circulating tumor fraction']","['palbociclib plus fulvestrant', 'placebo plus fulvestrant', 'Fulvestrant With or Without Palbociclib']","['Progression-free survival (PFS', 'FGFR1 amplification', 'PFS']","[{'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}]",459.0,0.302989,"In multivariable analysis, high-circulating tumor fraction was associated with worse PFS (HR = 1.20 per 10% increase in tumor fraction, 95% CI = 1.09 to 1.32; P < .001), as was TP53 mutation (HR = 1.84, 95% CI = 1.27 to 2.65; P = .001) and FGFR1 amplification (HR = 2.91, 95% CI = 1.61 to 5.25; P < .001).","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': ""O'Leary"", 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Cutts', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hrebien', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Université Paris Sud, Villejuif, France.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Martin Behaim-Strasse 12, Neu-Isenburg, Germany.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Division of Research and Cancer Medicine, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Garcia-Murillas', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Centre, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London, UK.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djaa087']
2854,32940695,"Effects of caloric restriction on human physiological, psychological, and behavioral outcomes: highlights from CALERIE phase 2.","Caloric restriction (CR) is a strategy that attenuates aging in multiple nonhuman species. The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trials are part of a research program aiming to test the effects of CR on aging and longevity biomarkers in humans. Building on CALERIE phase 1, CALERIE phase 2 (CALERIE 2) was the largest study to date to assess sustained CR in healthy humans without obesity. In a 24-month randomized controlled trial comprising 218 participants at baseline, CALERIE 2 showed that moderate CR, 11.9% on average, induced improvements in aging-related biomarkers without adversely affecting psychological or behavioral outcomes. The objectives of this report are to summarize and review the highlights of CALERIE 2 and report previously unpublished results on eating disorder symptoms and cognitive function. This article specifically summarizes the physiological, psychological, aging, behavioral, and safety results of the trial. Also provided are research directions beyond CALERIE 2 that highlight important opportunities to investigate the role of CR in aging, longevity, and health span in humans.",2020,The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trials are part of a research program aiming to test the effects of CR on aging and longevity biomarkers in humans.,"['218 participants', 'healthy humans without obesity', 'humans']","['Caloric restriction (CR', 'caloric restriction']","['psychological or behavioral outcomes', 'human physiological, psychological, and behavioral outcomes']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",218.0,0.0428277,The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trials are part of a research program aiming to test the effects of CR on aging and longevity biomarkers in humans.,"[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'van Vliet', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Manjushri', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Stewart', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}]",Nutrition reviews,['10.1093/nutrit/nuaa085']
2855,32940699,Association of altered folylpolyglutamate synthetase pre-mRNA splicing with methotrexate unresponsiveness in early rheumatoid arthritis.,"OBJECTIVES


An efficient pharmacological response to MTX treatment in RA patients relies on the retention and accumulation of intracellular MTX-polyglutamates catalysed by the enzyme folylpolyglutamate synthetase (FPGS). We recently identified a partial retention of FPGS intron 8 (8PR) as a prominent splice variant conferring FPGS dysfunction and decreased MTX polyglutamylation in acute lymphoblastic leukaemia. Here, we explored the association between FPGS 8PR levels and lack of MTX responsiveness in RA patients.
METHODS


Thirty-six patients undergoing MTX treatment were enrolled from the Combinatie behandeling Reumatoide Artritis (COBRA)-light trial. RNA was isolated from blood samples at baseline, 13 weeks and 26 weeks of therapy, from patients in either COBRA-light (n = 21) or COBRA (n = 15) treatment arms. RT-qPCR analysis was used to assess RNA levels of FPGS 8PR over wild-type FPGS (8WT).
RESULTS


In the COBRA-light treatment arm, higher baseline ratios of 8PR/8WT were significantly associated with higher 44-joint disease activity score (DAS44) at 13 and 26 weeks. Higher baseline ratios of 8PR/8WT also trended towards not obtaining low disease activity (DAS <1.6) and becoming a EULAR non-responder at 13 and 26 weeks. In the COBRA-treatment arm, a significant association was observed between high baseline 8PR/8WT ratios and higher DAS44 score at 26 weeks. Higher 8PR/8WT ratios were associated with non-response at week 26 based on both low disease activity and EULAR criteria.
CONCLUSION


This study is the first to associate alterations in FPGS pre-mRNA splicing levels with reduced responsiveness to MTX treatment in RA patients.
TRIAL REGISTRATION


ISRCTN55552928.",2020,"Higher 8PR/8WT ratios were associated with non-response at week 26 based on both low disease activity and EULAR criteria.
","['acute lymphoblastic leukaemia', 'RA patients', 'Thirty-six patients undergoing MTX treatment were enrolled from the Combinatie behandeling Reumatoide Artritis (COBRA)-light trial', 'early rheumatoid arthritis']","['MTX', 'COBRA']","['high baseline 8PR/8WT ratios and higher DAS44 score', 'FPGS 8PR levels and lack of MTX responsiveness', 'RNA levels of FPGS 8PR over wild-type FPGS (8WT', 'Higher 8PR/8WT ratios', '44-joint disease activity score (DAS44']","[{'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060626', 'cui_str': 'Folylpolyglutamate synthase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",36.0,0.0627548,"Higher 8PR/8WT ratios were associated with non-response at week 26 based on both low disease activity and EULAR criteria.
","[{'ForeName': 'Ittai B', 'Initials': 'IB', 'LastName': 'Muller', 'Affiliation': 'Department of Clinical Chemistry.'}, {'ForeName': 'Marry', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Clinical Chemistry.'}, {'ForeName': 'Willem F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center.'}, {'ForeName': 'Marieke M', 'Initials': 'MM', 'LastName': 'Ter Wee', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wojtuszkiewicz', 'Affiliation': 'Department of Hematology, Amsterdam UMC, location VUmc.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Nurmohamed', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, location Reade, Amsterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Department of Hematology, Amsterdam UMC, location VUmc.'}, {'ForeName': 'Yehuda G', 'Initials': 'YG', 'LastName': 'Assaraf', 'Affiliation': 'The Fred Wyszkowski Cancer Research Laboratory, Department of Biology, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Jansen', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Jonge', 'Affiliation': 'Department of Clinical Chemistry.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa428']
2856,32940718,The additional role of virtual to traditional dissection in teaching anatomy: a randomised controlled trial.,"INTRODUCTION


Anatomy has traditionally been taught via dissection and didactic lectures. The rising prevalence of informatics plays an increasingly important role in medical education. It is hypothesized that virtual dissection can express added value to the traditional one.
METHODS


Second-year medical students were randomised to study anatomical structures by virtual dissection (intervention) or textbooks (controls), according to the CONSORT guidelines. Subsequently, they applied to the corresponding gross dissection, with a final test on their anatomical knowledge. Univariate analysis and multivariable binary logistic regression were performed.
RESULTS


The rate of completed tests was 76.7%. Better overall test performance was detected for the group that applied to the virtual dissection (OR 3.75 with 95% CI 0.91-15.49; p = 0.06). A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13). Medical students who applied to the virtual dissection were over three times more likely to report a positive outcome at the post-dissection test than those who applied to textbooks of topographical anatomy. This would be of benefit with particular reference to the understanding of 2D-3D spatial relationships between anatomical structures.
CONCLUSION


The combination of virtual to traditional gross dissection resulted in a significant improvement of second-year medical students' learning outcomes. It could be of help in maximizing the impact of practical dissection, overcoming the contraction of economic resources, and the shortage of available bodies.",2020,"A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13).",['Second-year medical students'],"['virtual dissection (intervention) or textbooks (controls), according to the CONSORT guidelines']",['Better overall test performance'],"[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0266685,"A comparable performance between groups in basic anatomical knowledge (p 0.45 to 0.92) but not muscles and 2D-3D reporting of anatomical structures was found, for which the virtual dissection was of tendential benefit (p 0.08 to 0.13).","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Boscolo-Berto', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Tortorella', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Porzionato', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Stecco', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}, {'ForeName': 'Edgardo Enrico Edoardo', 'Initials': 'EEE', 'LastName': 'Picardi', 'Affiliation': 'Digestive System Surgery Division, European Institute of Oncology (IRCSS), Via Ripamonti 435, Milano, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Macchi', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy. veronica.macchi@unipd.it.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caro', 'Affiliation': 'Department of Neurosciences, Institute of Human Anatomy, University of Padova, Via Gabelli 65, Padova, Italy.'}]",Surgical and radiologic anatomy : SRA,['10.1007/s00276-020-02551-2']
2857,32940751,The effect of pre-operative high doses of methylprednisolone on pain management and convalescence after total hip replacement in elderly: a double-blind randomized study.,"PURPOSE


The aim of the study was to assess whether administration of a single dose of methylprednisolone in the group patients above 65 years of age will be effective in complex analgesic management after total hip arthroplasty (THA).
METHODS


Seventy-seven patients above 65 years old were double-blind randomized into two: the study and controls groups. Pre-operatively, the study group received as a single dose of 125 mg intravenous methylprednisolone, while the others saline solution as placebo. Peri-operatively, all the patients were administered opioid and nonopioid analgesic agents. We measured the levels of inflammatory markers (leukocytosis, C-reactive protein-CRP), pain intensity level (visual analog scale-VAS; numerical rating scale-NRS), the life parameters, and noted complications.
RESULTS


Following administration of methylprednisolone were significantly lower levels of CRP on all the four post-operative days; leukocytosis on the second day; the VAS/NRS score at rest after six, 12, and 18 hours post-operatively, diminished the dose of parenteral opioid preparations (oxycodone hydrochloride), the duration of analgesia by peripheral nerve block was significantly higher as compared with the placebo group (p < 0.000001). No infectious complications were noted; there was one patient who developed post-operative delirium.
CONCLUSION


A single dose of methylprednisolone significantly reduces the level of post-operative pain at rest on the day of THA in the group patients above 65 years of age, decreases the dose of opioid analgesic agents, and significantly decreases the level of inflammatory markers, without infectious processes.",2020,"RESULTS


Following administration of methylprednisolone were significantly lower levels of CRP on all the four post-operative days; leukocytosis on the second day; the VAS/NRS score at rest after six, 12, and 18 hours post-operatively, diminished the dose of parenteral opioid preparations (oxycodone hydrochloride), the duration of analgesia by peripheral nerve block was significantly higher as compared with the placebo group (p < 0.000001).","['group patients above 65\xa0years of age will be effective in complex analgesic management after total hip arthroplasty (THA', 'after total hip replacement in elderly', 'Seventy-seven patients above 65\xa0years old']","['saline solution as placebo', 'opioid and nonopioid analgesic agents', 'methylprednisolone', 'placebo', 'parenteral opioid preparations (oxycodone hydrochloride']","['infectious complications', 'level of post-operative pain', 'duration of analgesia by peripheral nerve block', 'levels of CRP', 'VAS/NRS score', 'level of inflammatory markers', 'pain management and convalescence', 'levels of inflammatory markers (leukocytosis, C-reactive protein-CRP), pain intensity level (visual analog scale-VAS; numerical rating scale-NRS), the life parameters, and noted complications']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0009940', 'cui_str': 'Convalescence'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",77.0,0.250748,"RESULTS


Following administration of methylprednisolone were significantly lower levels of CRP on all the four post-operative days; leukocytosis on the second day; the VAS/NRS score at rest after six, 12, and 18 hours post-operatively, diminished the dose of parenteral opioid preparations (oxycodone hydrochloride), the duration of analgesia by peripheral nerve block was significantly higher as compared with the placebo group (p < 0.000001).","[{'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Gądek', 'Affiliation': 'Department of Orthopedics and Physiotherapy, Jagiellonian University Collegium Medicum, Krakow, Poland.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Liszka', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital in Krakow, Krakow, Poland. henryk.liszka@uj.edu.pl.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Zając', 'Affiliation': 'Department of Orthopedics and Traumatology, University Hospital in Krakow, Krakow, Poland.'}]",International orthopaedics,['10.1007/s00264-020-04802-8']
2858,32934932,The Effect of Self-Management Training on Anxiety and Comfort of Burn Patients Candidate for Skin Grafting.,"BACKGROUND


Self-management programs on needs of burn patients are still essential. So this study determined the effect of self-management training on anxiety and comfort of burn patients who were candidate for skin grafting.
METHODS


In a continuous sampling method in Shahid Motahari Burn Center affiliated to Iran University of Medical Sciences, 80 burn patients candidate for skin grafting were divided into equal groups of intervention and control. Educational intervention was undertaken in the form of booklet during two sessions before and after skin grafting. Visual comfort scale questionnaire and Spiel Berger state-trait anxiety inventory were completed by patients before training and one month after intervention.
RESULTS


There was a significant difference between the frequency of comfort level in both groups before and after the intervention. The level of comfort in the intervention group increased more than control group. The mean level of patients' anxiety showed a significant difference between groups and scores in intervention group were significantly more than control group.
CONCLUSION


Attention and control of anxiety and comfort in burn patients are one of the essential elements of their care. It can be suggested that self-management training can reduce anxiety and increase burn patients' comfort.",2020,"The mean level of patients' anxiety showed a significant difference between groups and scores in intervention group were significantly more than control group.
","['Shahid Motahari Burn Center affiliated to Iran University of Medical Sciences, 80 burn patients candidate for skin grafting', 'Burn Patients Candidate for Skin Grafting', 'burn patients who were candidate for skin grafting']","['Self-Management Training', 'self-management training', 'Educational intervention']","[""mean level of patients' anxiety"", 'frequency of comfort level', 'Visual comfort scale questionnaire and Spiel Berger state-trait anxiety inventory', 'level of comfort']","[{'cui': 'C0006418', 'cui_str': 'Burn center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",80.0,0.0199876,"The mean level of patients' anxiety showed a significant difference between groups and scores in intervention group were significantly more than control group.
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shahryari', 'Affiliation': 'Department of Med ical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Seyedoshohadaee', 'Affiliation': 'Department of Med ical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Frough', 'Initials': 'F', 'LastName': 'Rafii', 'Affiliation': 'Department of Med ical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Khachian', 'Affiliation': 'Department of Med ical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mokhtar', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Med ical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}]",World journal of plastic surgery,['10.29252/wjps.9.2.200']
2859,32934974,"Two vs. three weeks of treatment with amoxicillin-clavulanate for stabilized community-acquired complicated parapneumonic effusions. A preliminary non-inferiority, double-blind, randomized, controlled trial.","Background


The optimal duration of antibiotic treatment for complicated parapneumonic effusions (CPPEs) has not been properly defined. Our aim was to compare the efficacy of amoxicillin-clavulanate for 2 vs. 3 weeks in patients with CPPE (i.e. those which required chest tube drainage).
Methods


In this non-inferiority, randomized, double-blind, controlled trial, patients with community-acquired CPPE were recruited from two centers in Spain and, after having obtained clinical stability following 2 weeks of amoxicillin-clavulanate, they were randomly assigned to placebo or antibiotic for an additional week. The primary objective was clinical success, tested for a non-inferiority margin of<10%. Secondary outcomes were the proportion of residual pleural thickening of>10 mm at 3 months, and adverse events. The study was registered with EudraCT, number 2014-003137-25. We originally planned to randomly assign 284 patients.
Results


After recruiting 55 patients, the study was terminated early owing to slow enrolment. A total of 25 patients were assigned to 2 weeks and 30 patients to 3 weeks of amoxicillin-clavulanate. Clinical success occurred in the 25 (100%) patients treated for 2 weeks and 29 (97%) treated for 3 weeks (difference 3%, 95% CI -3 to 9.7%). Respective between-group differences in the rate of residual pleural thickening (-12%, 95%CI -39 to 14%) and adverse events (-7%, 95%CI -16 to 2%) did not reach statistical significance.
Conclusions


In this small series of selected adult patients with community-acquired CPPE, amoxicillin-clavulanate treatment could be safely discontinued by day 14 if clinical stability was obtained.",2020,"Respective between-group differences in the rate of residual pleural thickening (-12%, 95%CI -39 to 14%) and adverse events (-7%, 95%CI -16 to 2%) did not reach statistical significance.
","['selected adult patients with community-acquired CPPE', '284 patients', 'patients with community-acquired CPPE were recruited from two centers in Spain and, after having obtained clinical stability following 2\u2006weeks of', 'complicated parapneumonic effusions (CPPEs', 'patients with CPPE (i.e. those which required chest tube drainage', '25 patients']","['amoxicillin-clavulanate treatment', 'placebo or antibiotic', 'amoxicillin-clavulanate']","['proportion of residual pleural thickening of>10\u2006mm at 3\u2006months, and adverse events', 'rate of residual pleural thickening', 'Clinical success', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0264550', 'cui_str': 'Pleural effusion associated with pulmonary infection'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0264545', 'cui_str': 'Thickening of pleura'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",25.0,0.542485,"Respective between-group differences in the rate of residual pleural thickening (-12%, 95%CI -39 to 14%) and adverse events (-7%, 95%CI -16 to 2%) did not reach statistical significance.
","[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Porcel', 'Affiliation': 'Pleural Medicine Unit, Department of Internal Medicine, Arnau de Vilanova University Hospital, IRBLleida, Lleida, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ferreiro', 'Affiliation': 'Department of Pulmonology, University Clinical Hospital of Santiago, Health Research Institute of Santiago de Compostela (IDIS), A Coruña, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rumi', 'Affiliation': 'Department of Pharmacy, Arnau de Vilanova University Hospital, IRBLleida, Lleida, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Espino-Paisán', 'Affiliation': 'Department of Pharmacy, Hospital de Barbanza, A Coruña, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Civit', 'Affiliation': 'Pleural Medicine Unit, Department of Internal Medicine, Arnau de Vilanova University Hospital, IRBLleida, Lleida, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pardina', 'Affiliation': 'Department of Radiology, Arnau de Vilanova University Hospital, IRBLleida, Lleida, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Schoenenberger-Arnaiz', 'Affiliation': 'Department of Pharmacy, Arnau de Vilanova University Hospital, IRBLleida, Lleida, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Valdés', 'Affiliation': 'Department of Pulmonology, University Clinical Hospital of Santiago, Health Research Institute of Santiago de Compostela (IDIS), A Coruña, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bielsa', 'Affiliation': 'Pleural Medicine Unit, Department of Internal Medicine, Arnau de Vilanova University Hospital, IRBLleida, Lleida, Spain.'}]",Pleura and peritoneum,['10.1515/pp-2019-0027']
2860,32934985,Optimal effect-site concentration of remifentanil to prevent hemodynamic changes during nasotracheal intubation using a video laryngoscope.,"Background


Nasotracheal intubation is the most commonly used method to secure the field of view when performing surgery on the oral cavity or neck. Like orotracheal intubation, nasotracheal intubation uses a laryngoscope. Hemodynamic change occurs due to the stimulation of the sympathetic nervous system. Recently, video laryngoscope with a camera attached to the end of the direct laryngoscope blade has been used to minimize this change. In this study, we investigated the optimal effect-site concentration (Ce) of remifentanil for minimizing hemodynamic responses during nasotracheal intubation with a video laryngoscope.
Methods


Twenty-one patients, aged between 19 and 60 years old, scheduled for elective surgery were included in this study. Anesthesia was induced by slowly injecting propofol. At the same time, remifentanil infusion was initiated at 3.0 ng/ml via target-controlled infusion (TCI). When remifentanil attained the preset Ce, nasotracheal intubation was performed using a video laryngoscope. The patient's blood pressure and heart rate were checked pre-induction, right before and after intubation, and 1 min after intubation. Hemodynamic stability was defined as an increase in systolic blood pressure and heart rate by 20% before and after nasotracheal intubation. The response of each patient determined the Ce of remifentanil for the next patient at an interval of 0.3 ng/ml.
Results


The  Ce  of remifentanil administered ranged from 2.4 to 3.6 ng/ml for the patients evaluated. The estimated optimal effective effect-site concentrations of remifentanil were 3.22 and 4.25 ng/ml, that were associated with a 50% and 95% probability of maintaining hemodynamic stability, respectively.
Conclusion


Nasotracheal intubation using a video laryngoscope can be successfully performed in a hemodynamically stable state by using the optimal remifentanil effect-site concentration ( Ce 50  , 3.22 ng/ml;  Ce 95  , 4.25 ng/ml).",2020,The estimated optimal effective effect-site concentrations of remifentanil were 3.22 and 4.25,"['Methods\n\n\nTwenty-one patients, aged between 19 and 60 years old, scheduled for elective surgery']",['remifentanil'],"['hemodynamic responses', 'blood pressure and heart rate', 'systolic blood pressure and heart rate', 'Hemodynamic stability', 'hemodynamic changes']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.165919,The estimated optimal effective effect-site concentrations of remifentanil were 3.22 and 4.25,"[{'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Yoon', 'Affiliation': 'Department of Dental Anesthesia and Pain Medicine, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan, Republic of Korea.'}, {'ForeName': 'Chul-Gue', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Department of Dental Anesthesia and Pain Medicine, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan, Republic of Korea.'}, {'ForeName': 'Eun-Jung', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Anesthesia and Pain Medicine, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan, Republic of Korea.'}, {'ForeName': 'Byung-Moon', 'Initials': 'BM', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Uk', 'Initials': 'JU', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University, Yangsan, Republic of Korea.'}, {'ForeName': 'Yeon Ha', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Integrated Biological Science, Pusan National University, Geumjeong-gu, Busan, Republic of Korea.'}, {'ForeName': 'Moon Ok', 'Initials': 'MO', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Ki Seob', 'Initials': 'KS', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Ji-Hye', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Dental Anesthesia and Pain Medicine, School of Dentistry, Pusan National University, Dental Research Institute, Yangsan, Republic of Korea.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.4.195']
2861,32934986,Single buccal infiltration of high concentration lignocaine versus articaine in maxillary third molar surgery.,"Background


This research evaluated the numbness produced by lignocaine at an equal or higher concentration than that of 4% articaine through a single point of injection for maxillary third molar surgery. This randomized double-blind study was conducted to compare the anesthetic efficiency of 4% lignocaine with that of 4% articaine in impacted maxillary third molar surgery using a single buccal infiltration alone.
Methods


The study participants were 30 healthy patients requiring the bilateral surgical removal of symmetrically-positioned maxillary third molars. Using a split-mouth design, each patient randomly received buccal infiltration of 1.7 ml of 4% lignocaine and 1.7 ml of 4% articaine during two separate appointments. After 15 minutes of anesthetic injection, surgery was performed by the same surgeon using a consistent technique on both sides. Pinprick test pain scores of the buccal and palatal gingiva of the maxillary third molar after 10 minutes and 15 minutes latencies, pain scores during the surgery, the need for supplemental anesthesia, and patients' satisfaction with anesthetic efficiency were recorded. Surgery performed without supplemental anesthesia was categorized as successful.
Results


The success rates of 4% lignocaine and 4% articaine (83.34% vs. 86.67%, P = 1.00) were not significantly different. Only 5 cases (4 cases in the articaine group and 1 case in the lignocaine group) reported mild pain and pressure sensation (NRS ≤ 1) on probing at the palatal side after 15 minutes of latency (P = 0.25). The pain scores of maxillary third molar surgery in the two groups were not significantly different (P > 0.05). Moreover, the statistical analysis confirmed the comparable patient satisfaction of two study groups (P = 0.284).
Conclusion


This study provides evidence that single buccal infiltrations of 4% lignocaine and 4% articaine have comparable anesthetic efficacy and success rates for impacted maxillary third molar surgery. Both 4% lignocaine and 4% articaine can produce effective palatal anesthesia and pain control using buccal infiltration alone after 15 minutes of latency.",2020,The pain scores of maxillary third molar surgery in the two groups were not significantly different (P > 0.05).,"['impacted maxillary third molar surgery', 'impacted maxillary third molar surgery using a single buccal infiltration alone', '30 healthy patients requiring the bilateral surgical removal of symmetrically-positioned maxillary third molars', 'maxillary third molar surgery']","['lignocaine', 'articaine', 'Surgery performed without supplemental anesthesia', 'buccal infiltration of 1.7 ml of 4% lignocaine and 1.7 ml of 4% articaine']","['mild pain and pressure sensation', 'anesthetic efficiency', 'success rates', 'pain scores of maxillary third molar surgery', 'anesthetic efficacy and success rates', 'effective palatal anesthesia and pain control', 'Pinprick test pain scores of the buccal and palatal gingiva of the maxillary third molar after 10 minutes and 15 minutes latencies, pain scores']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0234222', 'cui_str': 'Baresthesia'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4285979', 'cui_str': 'Palatal anaesthesia'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",30.0,0.14726,The pain scores of maxillary third molar surgery in the two groups were not significantly different (P > 0.05).,"[{'ForeName': 'Hnin Ei', 'Initials': 'HE', 'LastName': 'Phyo', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Teeranut', 'Initials': 'T', 'LastName': 'Chaiyasamut', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sirichai', 'Initials': 'S', 'LastName': 'Kiattavorncharoen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Verasak', 'Initials': 'V', 'LastName': 'Pairuchvej', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Bishwa Prakash', 'Initials': 'BP', 'LastName': 'Bhattarai', 'Affiliation': 'Walailak University International College of Dentistry, Bangkok, Thailand.'}, {'ForeName': 'Natthamet', 'Initials': 'N', 'LastName': 'Wongsirichat', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.4.203']
2862,32934987,Comparison of lidocaine with articaine buccal injection in reducing complications following impacted mandibular third molar surgery: a split-mouth randomized clinical trial.,"Background


Complications following impacted third molar surgery significantly affect patients' quality of life during the immediate postoperative period. This study aimed to achieve the proper anesthesia method by comparing the effect of the application of lidocaine alone with the application of lidocaine and articaine simultaneously in reducing the complications during and following impacted mandibular third molar surgery.
Methods


The study design was a split-mouth double-blind randomized clinical trial. The study was conducted on 13 patients (26 samples) referred for elective surgical removal of bilateral impacted mandibular third molar with similar difficulty on both sides. Each patient underwent similar surgical procedures on two separate appointments. Each patient randomly received 2% lidocaine for conventional inferior alveolar nerve block and 4% articaine for local infiltration before the surgery on one side (group A) and 2% lidocaine alone (for both block anesthesia and infiltration) before the surgery on the other side (group B). Intraoperative and postoperative variables for both groups were established and statistically analyzed.
Results


The findings showed that pain on the first day after surgery in group A was significantly lower than that in group B. The patients in group A mentioned experiencing less discomfort following the surgery. The increased horizontal swelling on the first and third days following surgery and oblique swelling on the seventh day in patients in group B were statistically significant.
Conclusion


Choosing an appropriate anesthetic drug for oral surgery, specifically impacted third molar surgery, is dependent on the clinician's opinion, however; it seems that the combination of lidocaine and articaine may control the patient's pain significantly better than lidocaine alone.",2020,The findings showed that pain on the first day after surgery in group A was significantly lower than that in group B.,"['impacted mandibular third molar surgery', '13 patients (26 samples) referred for elective surgical removal of bilateral impacted mandibular third molar with similar difficulty on both sides']","['articaine buccal injection', 'lidocaine for conventional inferior alveolar nerve block and 4% articaine', 'lidocaine and articaine', 'lidocaine alone', 'articaine', 'lidocaine']","['horizontal swelling', 'Intraoperative and postoperative variables', ""patients' quality of life"", 'complications', 'pain']","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",13.0,0.203987,The findings showed that pain on the first day after surgery in group A was significantly lower than that in group B.,"[{'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Naghipour', 'Affiliation': 'Student Research Committee, School of Dentistry, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Esmaeelinejad', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Dehnad', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Shahi', 'Affiliation': 'Department of Periodontology, School of Dentistry, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Jarrahi', 'Affiliation': 'Student Research Committee, School of Dentistry, Semnan University of Medical Sciences, Semnan, Iran.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.4.213']
2863,32934988,A prospective randomized trial of xylometazoline drops and epinephrine merocele nasal pack for reducing epistaxis during nasotracheal intubation.,"Background


The most frequent complication of nasotracheal intubation (NTI) is epistaxis. Epinephrine nasal gauze packing has been used conventionally as a pre-treatment for reducing epistaxis, but it carries a disadvantage of pain and anxiety in patients. However, xylometazoline drops are easier to administer and more convenient for patients. We aimed at comparing the effectiveness of xylometazoline drops and epinephrine merocele packing in reducing bleeding and postoperative complications in our population.
Methods


Our study enrolled 120 patients in a double-blind randomized controlled trial. We randomly allocated ASA1 or 2 adult patients into 2 groups: Group X and Group E. Group X received 0.1% xylometazoline nasal drops, and epinephrine (1:10,000) merocele nasal packing was used in Group E. The primary outcome was the incidence of bleeding during NTI; the severity of bleeding, navigability, bleeding during extubation, and postoperative complications were secondary outcomes. We used IBM SPSS and Minitab software for statistical analysis, and P < 0.05 was considered statistically significant.
Results


We analyzed the data of 110 patients: 55 in Group X and 55 in Group E. The two groups did not have different bleeding incidence (56.4% vs 60.0%; P = 0.70); however, the incidence of severe bleeding was less with xylometazoline than with epinephrine (3.63% vs 14.54%; P < 0.05). We also observed less bleeding during extubation (38.2% vs 68.5%; P < 0.05) with xylometazoline. Other secondary outcomes were akin to both groups.
Conclusion


The incidence of severe and post-extubation bleeding was significantly less with xylometazoline. Hence, it may be an effective alternative for reducing the incidence and severity of epistaxis during NTI.",2020,"The two groups did not have different bleeding incidence (56.4% vs 60.0%; P = 0.70); however, the incidence of severe bleeding was less with xylometazoline than with epinephrine (3.63% vs 14.54%; P < 0.05).","['120 patients', 'epistaxis during nasotracheal intubation', '110 patients: 55 in Group X and 55 in Group E']","['xylometazoline nasal drops, and epinephrine (1:10,000) merocele nasal packing', 'epinephrine', 'epinephrine merocele packing', 'Epinephrine nasal gauze packing', 'xylometazoline', 'ASA1', 'epinephrine merocele nasal pack']","['incidence of severe bleeding', 'incidence of severe and post-extubation bleeding', 'bleeding during extubation', 'bleeding incidence', 'incidence of bleeding during NTI; the severity of bleeding, navigability, bleeding during extubation, and postoperative complications', 'bleeding and postoperative complications']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0441857', 'cui_str': 'Group X'}, {'cui': 'C0441839', 'cui_str': 'Group E'}]","[{'cui': 'C0078643', 'cui_str': 'xylometazoline'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0456969', 'cui_str': '1 International Unit in 0.1mL'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",120.0,0.0906272,"The two groups did not have different bleeding incidence (56.4% vs 60.0%; P = 0.70); however, the incidence of severe bleeding was less with xylometazoline than with epinephrine (3.63% vs 14.54%; P < 0.05).","[{'ForeName': 'Sonam', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Amarjyoti', 'Initials': 'A', 'LastName': 'Hazarika', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Prachi', 'Initials': 'P', 'LastName': 'Agrawal', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Naresh Kumar', 'Initials': 'NK', 'LastName': 'Panda', 'Affiliation': 'Department of Otorhinolaryngology, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.4.223']
2864,32934989,"Anesthetic efficacy and safety of 2% lidocaine hydrochloride with 1:100,000 adrenaline and 4% articaine hydrochloride with 1:100,000 adrenaline as a single buccal injection in the extraction of maxillary premolars for orthodontic purposes.","Background


Palatal injection of local anesthetics is the most painful injection. To obviate the need for palatal injections, local anesthetic agents with diffusibility are being investigated. Hence the present study was designed to analyze the anesthetic efficacy of 2% lidocaine hydrochloride (HCl) with 1:100,000 adrenaline and 4% articaine hydrochloride (HCl) with 1:100,000 adrenaline using single buccal infiltration for the extraction of maxillary premolars.
Methods


A prospective, double-blind, crossover, randomized clinical study was performed on 60 consecutive systemically healthy patients with an age range of 15-30 years, requiring extraction of asymptomatic bilateral maxillary premolars for orthodontic purposes. They received 1ml buccal infiltration of 4% articaine HCl with 1:100,000 adrenaline on one side and 2% lidocaine HCl with 1:100,000 adrenaline on the other side. The extraction procedure on either side was scheduled 14 days apart. Parameters assessed were the time of onset of anesthesia, intraoperative discomfort, hemodynamic parameters, and the duration of analgesia. Analysis of the data was done using the Mann-Whitney test, the Wilcoxon test, the Kruskal-Wallis ANOVA test, and the chi-square test. Statistical significance was established at P < 0.05.
Results


Articaine showed a faster time of onset and longer duration of analgesia than lidocaine. However, the difference in the intraoperative discomfort and hemodynamic parameters was statistically insignificant.
Conclusion


Within the limitations of the study, it can be concluded that the extraction of maxillary premolars can be performed with a single buccal infiltration of 2% lidocaine HCl with 1:100,000 adrenaline, which is one of the most commonly used local anesthetic agent.",2020,"However, the difference in the intraoperative discomfort and hemodynamic parameters was statistically insignificant.
","['maxillary premolars for orthodontic purposes', '60 consecutive systemically healthy patients with an age range of 15-30 years, requiring extraction of asymptomatic bilateral maxillary premolars for orthodontic purposes']","['Articaine', 'adrenaline', 'articaine HCl with 1:100,000 adrenaline', 'lidocaine HCl with 1:100,000 adrenaline', 'lidocaine hydrochloride with 1:100,000 adrenaline and 4% articaine hydrochloride with 1:100,000 adrenaline', 'lidocaine hydrochloride (HCl) with 1:100,000 adrenaline and 4% articaine hydrochloride (HCl', 'lidocaine']","['intraoperative discomfort and hemodynamic parameters', 'faster time of onset and longer duration of analgesia', 'Anesthetic efficacy and safety', 'time of onset of anesthesia, intraoperative discomfort, hemodynamic parameters, and the duration of analgesia', 'anesthetic efficacy']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0007300', 'cui_str': 'Articaine hydrochloride'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine hydrochloride'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",60.0,0.0827129,"However, the difference in the intraoperative discomfort and hemodynamic parameters was statistically insignificant.
","[{'ForeName': 'Nupoor', 'Initials': 'N', 'LastName': 'Deshpande', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, DMIMS, Sawangi, India.'}, {'ForeName': 'Anendd', 'Initials': 'A', 'LastName': 'Jadhav', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, DMIMS, Sawangi, India.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Bhola', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, DMIMS, Sawangi, India.'}, {'ForeName': 'Manan', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, DMIMS, Sawangi, India.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.4.233']
2865,32934990,Topical anesthesia for stainless steel crown tooth preparation in primary molars: a pilot study.,"Background


Placement of full-coverage restorations such as stainless steel crowns (SSCs) for pulpectomy treated primary molars is essential for successful outcomes. The tooth preparation process for SSCs can cause discomfort to gingival tissues since the crown should be seated 1 mm subgingivally. The purpose of this prospective trial was to compare the effectiveness of subgingival and transmucosal application of topical anesthetics on dental pain during SSC tooth preparation among 6- to 8-year-old children.
Methods


A consecutive sample of 27 children, aged 6-8 years, who required an SSC after pulp therapy in primary molars were randomly divided into three groups. Group A received infiltration anesthesia before tooth preparation for SSC placement, whereas in Group B and C, only topical anesthesia was applied subgingivally and transmucosally. Wong-Bakers Faces pain rating scale (WBFPS) scores were recorded after tooth preparation. Faces, Legs, Activity, Cry and Consolability (FLACC) scores were evaluated by two blinded and calibrated investigators through video recordings of the patient during tooth preparation. Data were tabulated, and inter-group comparisons were performed using the Kruskal-Wallis and analysis of variance tests.
Results


Out of the 27 participants, 48% were boys and 52% were girls, with an overall mean age of 6.83 years. Group A showed the least pain scores according to both the scales, followed by Group B and Group C. The pain intensity was statistically significant on both the pain scales with P = 0.003 for FLACC and P < 0.001 for WBFPS.
Conclusion


Subgingival application of topical anesthesia reduced pain to a certain extent but not as effectively as infiltration anesthesia during SSC tooth preparation in primary molars. Transmucosal application of topical anesthesia did not reduce discomfort when compared to the other two interventions.",2020,"The pain intensity was statistically significant on both the pain scales with P = 0.003 for FLACC and P < 0.001 for WBFPS.
","['27 children, aged 6-8 years, who required an SSC after pulp therapy in primary molars', 'stainless steel crown tooth preparation in primary molars', ' 48% were boys and 52% were girls, with an overall mean age of 6.83 years', '27 participants', '6- to 8-year-old children']","['topical anesthetics', 'topical anesthesia', 'stainless steel crowns (SSCs', 'Topical anesthesia', 'infiltration anesthesia before tooth preparation for SSC placement']","['Faces, Legs, Activity, Cry and Consolability (FLACC) scores', 'least pain scores', 'pain intensity', 'pain scales', 'dental pain', 'discomfort', 'Wong-Bakers Faces pain rating scale (WBFPS) scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1306815', 'cui_str': 'Pulp treatment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0226993', 'cui_str': 'Structure of crown of tooth'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0376508', 'cui_str': 'Tooth Preparation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",27.0,0.0723557,"The pain intensity was statistically significant on both the pain scales with P = 0.003 for FLACC and P < 0.001 for WBFPS.
","[{'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Padminee', 'Affiliation': 'Department of Pedodontics, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hemalatha', 'Affiliation': 'Department of Pedodontics, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': 'Department of Pedodontics, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Senthil', 'Affiliation': 'Department of Pedodontics, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'Gnanabagyan J', 'Initials': 'GJ', 'LastName': 'Trophimus', 'Affiliation': 'Department of Pedodontics, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.4.241']
2866,32935066,Standing up against office sitting: A study protocol.,"Background


Sedentary behaviour is associated with cardiometabolic diseases amongst office-bound workers, mostly through extended sitting and engaging in low-energy-demanding activities during work hours. The aim of this study is to assess the effectiveness of standing desks and healthy messages on cardiovascular parameters in a cohort of office-based workers and to explore the perceptions of these workers about the suitability of this intervention to lower occupation-related sedentariness.
Methods/design


The protocol will use a mixed-methods study design. Phase 1 of this study is a 12-month, single blinded, randomised controlled trial, which will include baseline, 3-month, 6-month and 12-month post-intervention assessments of plausible cardiometabolic risk biomarkers in office-bound workers at a South African credit and information management company. These biomarkers include anthropometry, sedentary behaviour and physical activity, sleep duration, blood pressure, glucose, glycated haemoglobin (HbA1c), lipid profile and cardiorespiratory fitness. Participants will be randomised into an intervention or control group. The intervention group will be provided with an adjustable sit-stand desk and receive weekly health-promoting messages for the intervention period. Phase 2 will use focus group discussions conducted post-intervention to explore the study participants' perceptions of the effectiveness of the intervention. Cardiometabolic risk biomarkers and changes in these variables will be compared between the intervention group and the control group at the four time points using descriptive and inferential statistics.
Discussion


Regression analysis will be undertaken to determine the association of cardiometabolic risk biomarkers with cardiometabolic diseases. A thematic content analysis approach will be used to explore emerging themes from focus group discussions.
Protocol identification


Pan African Clinical Trial Registry, PACTR201911656014962.",2020,Phase 2 will use focus group discussions conducted post-intervention to explore the study participants' perceptions of the effectiveness of the intervention.,['office-bound workers at a South African credit and information management company'],"['adjustable sit-stand desk and receive weekly health-promoting messages for the intervention period', 'standing desks and healthy messages']","['plausible cardiometabolic risk biomarkers', 'cardiovascular parameters', 'Cardiometabolic risk biomarkers', 'anthropometry, sedentary behaviour and physical activity, sleep duration, blood pressure, glucose, glycated haemoglobin (HbA1c), lipid profile and cardiorespiratory fitness']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0012972', 'cui_str': 'Information Management'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.104727,Phase 2 will use focus group discussions conducted post-intervention to explore the study participants' perceptions of the effectiveness of the intervention.,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gradidge', 'Affiliation': 'Centre for Exercise Science and Sports Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Merling', 'Initials': 'M', 'LastName': 'Phaswana', 'Affiliation': 'Centre for Exercise Science and Sports Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Wijndaele', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Crowther', 'Affiliation': 'Department of Chemical Pathology, National Health Laboratory Service, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Draper', 'Affiliation': 'MRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",The South African journal of physiotherapy,['10.4102/sajp.v76i1.1415']
2867,32935090,"Patient-Reported Health Outcomes After Treatment of COVID-19 with Nebulized and/or Intravenous Neutral Electrolyzed Saline Combined with Usual Medical Care Versus Usual Medical care alone: A Randomized, Open-Label, Controlled Trial.","Background:  Coronavirus disease (COVID-19) is currently the main public health problem worldwide. The administration of neutral electrolyzed saline, a solution that contains reactive species of chlorine and oxygen (ROS), may be an effective therapeutic alternative due to its immunomodulating characteristics, in systemic inflammation control, as well as in immune response improvement, promoting control of the viral infection. The present study evaluated the efficacy of treatment with intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care  versus  usual medical care alone, in ambulatory patients with COVID-19.  Methods:  A prospective, 2-arm, parallel group, randomized, open-label, phase I-II clinical trial included 39 patients in the control group (usual medical care alone) and 45 patients in the experimental group (usual medical care + intravenous and/or nebulized electrolyzed saline, with dose escalation). Two aspects were evaluated during the twenty-day follow-up: i) the number of patients with disease progression (hospitalization or death); and ii) the Patient Acceptable Symptom State (PASS), a single-question outcome that determines patient well-being thresholds for pain and function. Biochemical and hematologic parameters, as well as adverse effects, were evaluated in the experimental group.  Results:  The experimental treatment decreased the risk for hospitalization by 92% (adjusted RR=0.08, 95% CI: 0.01-0.50, P=0.007), with a 43-fold increase in the probability of achieving an acceptable symptom state on day 5 (adjusted RR= 42.96, 95% CI: 9.22-200.0, P<0.001). Intravenous + nebulized administration was better than nebulized administration alone, but nebulized administration was better than usual medical care alone. Clinical improvement correlated with a decrease in C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets. Cortisol and testosterone levels were also evaluated, observing a decrease in cortisol levels and an increment of testosterone-cortisol ratio, on days 2 and 4.  Conclusions:  The experimental treatment produced no serious adverse effects. In conclusion, intravenous and/or nebulized neutral electrolyzed saline importantly reduced the symptomatology and risk of progression (hospitalization and death), in ambulatory patients with COVID-19.  Trial registration:  Cuban Public Registry of Clinical Trials (RPCEC) Database RPCEC00000309. Registered: 05. May 2020. https://rpcec.sld.cu/en/trials/RPCEC00000309-En.",2020,"Clinical improvement correlated with a decrease in C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets.","['ambulatory patients with COVID-19', '39 patients in the']","['neutral electrolyzed saline, a solution that contains reactive species of chlorine and oxygen (ROS', 'control group (usual medical care alone) and 45 patients in the experimental group (usual medical care + intravenous and/or nebulized electrolyzed saline, with dose escalation', 'intravenous and/or nebulized neutral electrolyzed saline', 'intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care  versus  usual medical care alone', 'COVID-19 with Nebulized and/or Intravenous Neutral Electrolyzed Saline Combined with Usual Medical Care Versus Usual Medical care alone']","['C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets', 'testosterone-cortisol ratio', 'Health Outcomes', 'Cortisol and testosterone levels', 'serious adverse effects', 'symptomatology and risk of progression (hospitalization and death', 'risk for hospitalization', 'cortisol levels', 'number of patients with disease progression (hospitalization or death); and ii) the Patient Acceptable Symptom State (PASS), a single-question outcome that determines patient well-being thresholds for pain and function', 'probability of achieving an acceptable symptom state', 'Biochemical and hematologic parameters']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",39.0,0.125275,"Clinical improvement correlated with a decrease in C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Delgado-Enciso', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Paz-Garcia', 'Affiliation': ''}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Barajas-Saucedo', 'Affiliation': ''}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Mokay-Ramírez', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Meza-Robles', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Lopez-Flores', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Delgado-Machuca', 'Affiliation': ''}, {'ForeName': 'Efren', 'Initials': 'E', 'LastName': 'Murillo-Zamora', 'Affiliation': ''}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Toscano-Velazquez', 'Affiliation': ''}, {'ForeName': 'Josuel', 'Initials': 'J', 'LastName': 'Delgado-Enciso', 'Affiliation': ''}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Melnikov', 'Affiliation': ''}, {'ForeName': 'Mireya', 'Initials': 'M', 'LastName': 'Walle-Guillen', 'Affiliation': ''}, {'ForeName': 'Hector R', 'Initials': 'HR', 'LastName': 'Galvan-Salazar', 'Affiliation': ''}, {'ForeName': 'Osiris G', 'Initials': 'OG', 'LastName': 'Delgado-Enciso', 'Affiliation': ''}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Cabrera-Licona', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guzman-Esqu', 'Affiliation': ''}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Montes-Galindo', 'Affiliation': ''}, {'ForeName': 'Alejandra E', 'Initials': 'AE', 'LastName': 'Hernandez-Rangel', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Montes-Diaz', 'Affiliation': ''}, {'ForeName': 'Iram P', 'Initials': 'IP', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': ''}, {'ForeName': 'Margarita L', 'Initials': 'ML', 'LastName': 'Martinez-Fierro', 'Affiliation': ''}, {'ForeName': 'Idalia', 'Initials': 'I', 'LastName': 'Garza-Veloz', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tiburcio-Jimenez', 'Affiliation': ''}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Zaizar-Fregoso', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ramirez-Flores', 'Affiliation': ''}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Gaytan-Sandoval', 'Affiliation': ''}, {'ForeName': 'Carlos R', 'Initials': 'CR', 'LastName': 'Martinez-Perez', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Espinoza-Gómez', 'Affiliation': ''}, {'ForeName': 'Fabián', 'Initials': 'F', 'LastName': 'Rojas-Larios', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hirsch-Meillon', 'Affiliation': ''}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Barrios-Navarro', 'Affiliation': ''}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Oviedo-Rodriguez', 'Affiliation': ''}, {'ForeName': 'Luz M Baltazar', 'Initials': 'LMB', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Brenda A', 'Initials': 'BA', 'LastName': 'Paz-Michel', 'Affiliation': ''}]",Research square,['10.21203/rs.3.rs-68403/v1']
2868,32935154,Clinical outcomes of concurrent surgery with weight bearing after modified lasso-loop stitch arthroscopic ankle stabilization.,"PURPOSE


To determine the effects of unilateral and bilateral ankle stabilization surgery with or without additional concurrent procedures for other pathologies on return to activity in patients who were allowed unrestricted weight bearing postoperatively.
METHODS


Ninety-three athletes underwent 120 ankle stabilization surgeries including 27 that underwent bilateral simultaneous surgery using the all-inside arthroscopy-modified lasso-loop technique and were divided into two groups: arthroscopic ligament repair alone without concurrent procedures (group A) and with simultaneous procedures for other pathologies (group B). Group A was further subdivided into unilateral (group A1) and simultaneous bilateral ankle surgery (group A2), and group B into ankle stabilization surgery with simultaneous procedures not requiring weight bearing postoperatively (Group B1) and with concurrent procedures allowing weight bearing (Group B2). Return to activity postoperatively was assessed by recording the time to walk without any support, jog, and return to full athletic activities. Clinical outcomes were assessed preoperatively and 12 months postoperatively using a subjective clinical score.
RESULTS


The average time between surgery and unsupported walk, jog, and return to full athletic activities was 1.6 ± 2.5, 16.9 ± 3.7, and 42.4 ± 19.3 days in group A, 17.2 ± 19.6, 34.5 ± 20.8, and 60.9 ± 22.8 days in group B, 1.7 ± 2.9, 16.1 ± 2.4, and 41.6 ± 18.2 days in group A1, 1.3 ± 0.6, 18.9 ± 5.5, and 44.6 ± 22.5 days in group A2, 25.3 ± 20.2, 43.3 ± 21.1, and 70.7 ± 23.1 days in group B1, and 4.8 ± 11.7, 20.7 ± 11.7, and 45.0 ± 13.7 days in group B2, respectively. These results indicate that the patients in group B2 showed a statistically significant faster time to return to activity than did those restricted from weight bearing. Differences in ankle stabilization alone between patients in groups A1 and A2 as well as groups B2 and A were not statistically significant. Clinical outcomes were similar for patients in groups B2 and A1 versus group A2.
CONCLUSION


Time to return to activity and clinical outcomes after ankle stabilization surgery using the modified lasso-loop technique were negatively affected if simultaneous bilateral surgery or simultaneous concurrent procedures were added or if weight bearing was unrestricted. However, a delay in return to athletic activity was observed when ankle stabilization surgery was performed using the modified lasso-loop technique with concurrent procedures that require non-weight bearing postoperatively.
LEVEL OF EVIDENCE


Level III.",2020,Differences in ankle stabilization alone between patients in groups A1 and A2 as well as groups B2 and A were not statistically significant.,"['patients who were allowed unrestricted weight bearing postoperatively', 'Ninety-three athletes underwent 120 ankle stabilization surgeries including 27 that underwent']","['concurrent surgery with weight bearing after modified lasso-loop stitch arthroscopic ankle stabilization', 'simultaneous bilateral ankle surgery (group A2), and group B into ankle stabilization surgery with simultaneous procedures not requiring weight bearing postoperatively (Group B1) and with concurrent procedures allowing weight bearing (Group B2', 'arthroscopic ligament repair alone without concurrent procedures', 'unilateral and bilateral ankle stabilization surgery with or without additional concurrent procedures', 'bilateral simultaneous surgery using the all-inside arthroscopy-modified lasso-loop technique']","['faster time to return to activity', 'average time between surgery and unsupported walk, jog, and return to full athletic activities', 'subjective clinical score', 'delay in return to athletic activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0845707', 'cui_str': 'Ankle stabilisation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0845707', 'cui_str': 'Ankle stabilisation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0188412', 'cui_str': 'Operative procedure on ankle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0185417', 'cui_str': 'Repair of ligament'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022400', 'cui_str': 'Jogging'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.0299008,Differences in ankle stabilization alone between patients in groups A1 and A2 as well as groups B2 and A were not statistically significant.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takao', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan. m.takao@carifas.com.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Inokuchi', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Jujo', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan.'}, {'ForeName': 'Kosui', 'Initials': 'K', 'LastName': 'Iwashita', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Okugura', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Mori', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Komesu', 'Affiliation': 'Clinical and Research Institute for Foot and Ankle Surgery, 341-1, Mangoku, Kisarazu, Chiba, 292-0003, Japan.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Glazebrook', 'Affiliation': 'Division of Orthopaedic Surgery, Queen Elizabeth II Health Sciences Center Halifax Infirmary (Suite 4867), Dalhousie University, 1796 Summer Street 902 473-7137, Halifax, NS, B3H3A7, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06264-2']
2869,32935170,Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial.,"Abaloparatide increased ultradistal radius bone mineral density (BMD) in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial. Over the subsequent 24 months in ACTIVExtend, ultradistal radius BMD gains were maintained with alendronate. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE.
INTRODUCTION


Abaloparatide (ABL) increased femoral neck, total hip, and lumbar spine bone mineral density (BMD) in postmenopausal women with osteoporosis and decreased the risk of vertebral and nonvertebral fractures in ACTIVE. Effects on fracture risk and BMD were maintained subsequently with alendronate (ALN) in ACTIVExtend. In a prespecified subanalysis of ACTIVE, ABL also increased BMD at the ultradistal radius. Our objective was to determine the efficacy of ABL followed by ALN vs placebo (PBO) followed by ALN on forearm BMD and fracture risk over 43 months in ACTIVExtend.
METHODS


Ultradistal and 1/3 radius BMD (ACTIVE baseline to month 43) were measured (ABL/ALN, n = 213; PBO/ALN, n = 233). Wrist fracture rates were estimated for the ACTIVExtend intent-to-treat population (ABL/ALN, n = 558; PBO/ALN, n = 581) by Kaplan-Meier (KM) method.
RESULTS


At cumulative month 25, mean increase from ACTIVE baseline in ultradistal radius BMD was 1.1% (standard error, 0.49%) with ABL/ALN vs - 0.8% (0.43%) with PBO/ALN (P < 0.01). BMD increases with ABL were maintained with ALN through month 43 in ACTIVExtend. BMD decreases at the 1/3 radius in ACTIVE (similar with ABL and PBO) were maintained through 24 months of ALN treatment in ACTIVExtend. Wrist fractures over 43 months occurred in 15 women with ABL/ALN (KM estimate, 2.8%) and 20 with PBO/ALN (KM estimate, 3.6%) (HR = 0.77, 95% CI 0.39, 1.50; P = not significant).
CONCLUSION


Ultradistal radius BMD gains following treatment with ABL in ACTIVE were maintained over 24 months of ALN treatment in ACTIVExtend. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT01657162 submitted July 31, 2012.",2020,BMD decreases at the 1/3 radius in ACTIVE (similar with ABL and PBO) were maintained through 24 months of ALN treatment in ACTIVExtend.,['postmenopausal women with osteoporosis'],"['alendronate', 'alendronate (ALN', 'ALN vs placebo (PBO) followed by ALN']","['forearm BMD and fracture risk', 'ultradistal radius BMD', 'fracture risk and BMD', 'Wrist fracture rates', 'Forearm bone mineral density and fracture incidence', 'femoral neck, total hip, and lumbar spine bone mineral density (BMD', 'BMD', 'Wrist fractures', 'ultradistal radius BMD gains', 'BMD increases with ABL', 'ultradistal radius bone mineral density (BMD']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0435630', 'cui_str': 'Fracture of distal end of radius and ulna'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}]",,0.0831348,BMD decreases at the 1/3 radius in ACTIVE (similar with ABL and PBO) were maintained through 24 months of ALN treatment in ACTIVExtend.,"[{'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': 'Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Dore', 'Affiliation': 'Robin K. Dore, MD, Inc., Tustin, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baim', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA. bmitlak@radiuspharm.com.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Rozental', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05555-1']
2870,32935315,Specific Disease Knowledge as Predictor of Susceptibility to Availability Bias in Diagnostic Reasoning: a Randomized Controlled Experiment.,"BACKGROUND


Bias in reasoning rather than knowledge gaps has been identified as the origin of most diagnostic errors. However, the role of knowledge in counteracting bias is unclear.
OBJECTIVE


To examine whether knowledge of discriminating features (findings that discriminate between look-alike diseases) predicts susceptibility to bias.
DESIGN


Three-phase randomized experiment. Phase 1 (bias-inducing): Participants were exposed to a set of clinical cases (either hepatitis-IBD or AMI-encephalopathy). Phase 2 (diagnosis): All participants diagnosed the same cases; 4 resembled hepatitis-IBD, 4 AMI-encephalopathy (but all with different diagnoses). Availability bias was expected in the 4 cases similar to those encountered in phase 1. Phase 3 (knowledge evaluation): For each disease, participants decided (max. 2 s) which of 24 findings was associated with the disease. Accuracy of decisions on discriminating features, taken as a measure of knowledge, was expected to predict susceptibility to bias.
PARTICIPANTS


Internal medicine residents at Erasmus MC, Netherlands.
MAIN MEASURES


The frequency with which higher-knowledge and lower-knowledge physicians gave biased diagnoses based on phase 1 exposure (range 0-4). Time to diagnose was also measured.
KEY RESULTS


Sixty-two physicians participated. Higher-knowledge physicians yielded to availability bias less often than lower-knowledge physicians (0.35 vs 0.97; p = 0.001; difference, 0.62 [95% CI, 0.28-0.95]). Whereas lower-knowledge physicians tended to make more of these errors on subjected-to-bias than on not-subjected-to-bias cases (p = 0.06; difference, 0.35 [CI, - 0.02-0.73]), higher-knowledge physicians resisted the bias (p = 0.28). Both groups spent more time to diagnose subjected-to-bias than not-subjected-to-bias cases (p = 0.04), without differences between groups.
CONCLUSIONS


Knowledge of features that discriminate between look-alike diseases reduced susceptibility to bias in a simulated setting. Reflecting further may be required to overcome bias, but succeeding depends on having the appropriate knowledge. Future research should examine whether the findings apply to real practice and to more experienced physicians.",2020,"Higher-knowledge physicians yielded to availability bias less often than lower-knowledge physicians (0.35 vs 0.97; p = 0.001; difference, 0.62 [95% CI, 0.28-0.95]).","['Sixty-two physicians participated', 'Phase 2 (diagnosis', 'Internal medicine residents at Erasmus MC, Netherlands']",[],"['hepatitis-IBD, 4 AMI-encephalopathy', 'Availability bias']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],"[{'cui': 'C0019158', 'cui_str': 'Inflammatory disease of liver'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",,0.0212873,"Higher-knowledge physicians yielded to availability bias less often than lower-knowledge physicians (0.35 vs 0.97; p = 0.001; difference, 0.62 [95% CI, 0.28-0.95]).","[{'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Mamede', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands. s.mamede@erasmusmc.nl.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Goeijenbier', 'Affiliation': 'Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Stephanie C E', 'Initials': 'SCE', 'LastName': 'Schuit', 'Affiliation': 'Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'de Carvalho Filho', 'Affiliation': 'Centre for Educational Research and Development in Health Professions, University Medical Centre, Groningen, The Netherlands.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Staal', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zwaan', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Henk G', 'Initials': 'HG', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Education Research Rotterdam, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}]",Journal of general internal medicine,['10.1007/s11606-020-06182-6']
2871,32935453,Local Anesthesia Prior to Ultrasound Guided Hip Joint Injections: A Double-Blind Randomized Controlled Trial of Bacteriostatic Saline versus Buffered Lidocaine.,"BACKGROUND


Ultrasound (US) guided hip joint injections are commonly performed for patients with suspected or known intraarticular hip pain. Lidocaine is a well-established local anesthetic used prior to hip joint injections, but it is often associated with discomfort during infiltration. Bacteriostatic saline is an alternative local anesthetic that has been shown to be less painful during infiltration for superficial injections.
OBJECTIVE


To compare infiltrative pain and anesthetic efficacy of bacteriostatic saline (0.9% benzyl alcohol) with a standard local anesthetic (buffered 1% lidocaine) used for local anesthesia prior to US guided intraarticular hip corticosteroid injections.
DESIGN


Double-blinded, randomized controlled trial.
SETTING


Tertiary care medical center. This article is protected by copyright. All rights reserved.",2020,"To compare infiltrative pain and anesthetic efficacy of bacteriostatic saline (0.9% benzyl alcohol) with a standard local anesthetic (buffered 1% lidocaine) used for local anesthesia prior to US guided intraarticular hip corticosteroid injections.
","['Tertiary care medical center', 'patients with suspected or known intraarticular hip pain']","['Ultrasound (US) guided hip joint injections', 'bacteriostatic saline (0.9% benzyl alcohol', 'Bacteriostatic Saline versus Buffered Lidocaine', 'Bacteriostatic saline', 'standard local anesthetic (buffered 1% lidocaine', 'Local Anesthesia Prior to Ultrasound Guided Hip Joint Injections', 'Lidocaine']",['infiltrative pain and anesthetic efficacy'],"[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0005100', 'cui_str': 'Benzyl Alcohol'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.284832,"To compare infiltrative pain and anesthetic efficacy of bacteriostatic saline (0.9% benzyl alcohol) with a standard local anesthetic (buffered 1% lidocaine) used for local anesthesia prior to US guided intraarticular hip corticosteroid injections.
","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Kruse', 'Affiliation': 'Resident Physician, Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Kindle', 'Affiliation': 'Resident Physician, Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Wisniewski', 'Affiliation': 'Assistant Professor of Physical Medicine & Rehabilitation, Department of Physical Medicine & Rehabilitation, Sports Medicine Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Presley', 'Affiliation': 'Resident Physician, Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Professor of Physical Medicine & Rehabilitation, Departments of Physical Medicine & Rehabilitation, Radiology and Clinical Anatomy, Mayo Clinic Sports Medicine Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jacob L', 'Initials': 'JL', 'LastName': 'Sellon', 'Affiliation': 'Assistant Professor of Physical Medicine & Rehabilitation, Department of Physical Medicine & Rehabilitation, Sports Medicine Center, Mayo Clinic, Rochester, MN.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12489']
2872,32935460,"A Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Study of the Effects of Solriamfetol on QTcF Intervals in Healthy Participants.","Solriamfetol, a dopamine and norepinephrine reuptake inhibitor, is approved (United States and European Union; Sunosi) to treat excessive daytime sleepiness associated with narcolepsy (75-150 mg/day) or obstructive sleep apnea (37.5-150 mg/day). A thorough QT/QTc study assessed solriamfetol effects on QT interval (Fridericia correction for heart rate; QTcF). This randomized, double-blind, placebo- and positive-controlled, 4-period crossover study compared single doses of 300 and 900 mg solriamfetol, 400 mg moxifloxacin, and placebo in healthy adults. Placebo- and predose-adjusted mean differences in QTcF (ddQTcF; primary end point) were analyzed, and solriamfetol pharmacokinetics were characterized. Fifty-five participants completed all periods. Upper bounds of 2-sided 90% confidence intervals (CIs) for ddQTcF for both solriamfetol doses were <10 milliseconds at all postdose time points. Assay sensitivity was demonstrated with moxifloxacin; lower bounds of 2-sided 90%CIs for ddQTcF > 5 milliseconds at 1, 2, and 3 hours postdose. There were no QTcF increases > 60 milliseconds or QTcF values > 480 milliseconds at either solriamfetol dose. Solriamfetol median t max  was 2-3 hours; exposure was dose-proportional. More participants experienced adverse events (AEs) after solriamfetol 900 versus 300 mg (70% vs 29%); none were serious (all mild/moderate), and there were no deaths. Common AEs were nausea, dizziness, and palpitations. Neither solriamfetol dose resulted in QTcF prolongation > 10 milliseconds.",2020,There were no QTcF increases > 60 milliseconds or QTcF values > 480 milliseconds at either solriamfetol dose.,"['healthy adults', 'Healthy Participants']","['moxifloxacin', 'solriamfetol, 400\xa0mg moxifloxacin, and placebo', 'placebo', 'Solriamfetol', 'Placebo']","['QTcF prolongation', 'nausea, dizziness, and palpitations', 'Assay sensitivity', 'adverse events (AEs', 'obstructive sleep apnea']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C4726765', 'cui_str': 'Solriamfetol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030252', 'cui_str': 'Palpitations'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",55.0,0.401451,There were no QTcF increases > 60 milliseconds or QTcF values > 480 milliseconds at either solriamfetol dose.,"[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zomorodi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Swearingen', 'Affiliation': 'Celerion, Tempe, Arizona, USA.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.867']
2873,32935480,A phase III randomized controlled trial of radiation dose optimization in non-Hodgkin lymphoma-diffuse large B-cell lymphoma (DOBL study): Study protocol and design.,"BACKGROUND


Radiation therapy for diffuse large B-cell lymphoma (DLBCL) has shown improvement in progression free survival. There is uncertainty about the optimal radiation dose, with heterogeneous doses being used, ranging from 30 to 55 Gy. This trial tests the efficacy of using reduced radiation dose in DLBCL without compromising on long-term outcomes.
AIMS


The primary aim is to assess the noninferiority, as assessed by 2-year event free survival (EFS), of a dose de-escalated dose (36 Gy) for DLBCL as compared with a standard dose (45 Gy).
METHODS


The Dose Optimization in B cell Lymphomas (DOBL) study is a randomized phase-III noninferiority trial in a uniform cohort of DLBCL patients receiving immunochemotherapy (R-CHOP). Patients with stages I to IV of DLBCL eligible for radiotherapy (RT) after completion of at least four cycles of R-CHOP will be included in the study. Patients will be randomized to standard RT dose of 45 Gy in 25 fractions or reduced dose of 36 Gy in 20 fractions using involved site radiotherapy (ISRT) technique. It is a noninferiority design using a 7% noninferiority margin with a hazard ratio of 1.3, α of 0.05, and β of 0.80. A total of 760 patients will be accrued. Two-year EFS is the primary outcome measure that will be studied. The experimental arm will be stopped and switched over to control arm if on interim analysis, 25% events occur in the experimental arm.
DISCUSSION


The study is designed to test the noninferiority of radiation dose de-escalation in a uniform cohort of patients diagnosed with DLBCL and treated with R-CHOP regimen in the post-positron emission tomography (PET) era. The trial is rigorously designed and is straightforward to implement. It is statistically powered to answer if reducing the radiation doses does not compromise the clinical outcome in the given patient cohort. This trial will effectively set the standards in radiotherapy doses for DLBCL in the contemporary era.",2019,The study is designed to test the noninferiority of radiation dose de-escalation in a uniform cohort of patients diagnosed with DLBCL and treated with R-CHOP regimen in the post-positron emission tomography (PET) era.,"['diffuse large B-cell lymphoma (DLBCL', 'non-Hodgkin lymphoma-diffuse large B-cell lymphoma (DOBL study', 'patients diagnosed with DLBCL and treated with R-CHOP regimen in the post-positron emission tomography (PET) era', '760 patients will be accrued', 'Patients with stages I to IV of DLBCL eligible for']","['36\xa0Gy in 20 fractions using involved site radiotherapy (ISRT) technique', 'immunochemotherapy (R-CHOP', 'radiotherapy (RT']",[],"[{'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}]",[],760.0,0.172928,The study is designed to test the noninferiority of radiation dose de-escalation in a uniform cohort of patients diagnosed with DLBCL and treated with R-CHOP regimen in the post-positron emission tomography (PET) era.,"[{'ForeName': 'Jayant S', 'Initials': 'JS', 'LastName': 'Goda', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Homi Bhaba National Institute, Mumbai, India.'}, {'ForeName': 'Shirly C', 'Initials': 'SC', 'LastName': 'Lewis', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Homi Bhaba National Institute, Mumbai, India.'}, {'ForeName': 'Siddartha', 'Initials': 'S', 'LastName': 'Laskar', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Homi Bhaba National Institute, Mumbai, India.'}, {'ForeName': 'Sadhna', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Department of Epidemiology and Clinical Trials Unit, ACTREC, Tata Memorial Centre, Homi Bhaba National Institute, Navi Mumbai, India.'}, {'ForeName': 'Nehal', 'Initials': 'N', 'LastName': 'Khanna', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Homi Bhaba National Institute, Mumbai, India.'}, {'ForeName': 'Hasmukh', 'Initials': 'H', 'LastName': 'Jain', 'Affiliation': 'Department of Hemato Oncology, Tata Memorial Hospital, Homi Bhaba National Institute, Mumbai, India.'}, {'ForeName': 'Bhausaheb', 'Initials': 'B', 'LastName': 'Bagal', 'Affiliation': 'Department of Hemato Oncology, Tata Memorial Hospital, Homi Bhaba National Institute, Mumbai, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Epari', 'Affiliation': ''}]","Cancer reports (Hoboken, N.J.)",['10.1002/cnr2.1161']
2874,32935488,"Efficacy, Safety, and Immunomodulatory Effect of the Intramuscular Administration of Autologous Total Immunoglobulin G for Atopic Dermatitis: A Randomized Clinical Trial.","PURPOSE


The management of patients with atopic dermatitis (AD) is often difficult. We hypothesized that repeated intramuscular administration of autologous total immunoglobulin G (IgG) could induce clinical improvement in patients with AD through immune modulation. This clinical trial was conducted to evaluate the efficacy, safety, and immunomodulatory effect of the intramuscular administration of autologous total IgG in patients with AD.
METHODS


In this randomized, double-blind, placebo-controlled trial, 51 adolescent and adult patients with moderate-to-severe AD were randomized to receive 8 weekly intramuscular administrations of autologous total IgG 50 mg (n = 26) or saline (n = 25) over a 7-week period and were followed up to week 16. Changes in the clinical severity score (Eczema Area and Severity Index), affected body surface area, patient-reported Dermatology Life Quality Index (DLQI) score, laboratory biomarkers, and incidence of adverse events from baseline to week 16 were assessed.
RESULTS


The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (-64.8% vs. -20.3%,  P  < 0.001), reduced the affected body surface area (-53.9% vs. -19.1%,  P  < 0.001), improved the DLQI score (-35.4% vs. -14.4%,  P  = 0.015), increased serum interleukin-10 and interferon-γ levels ( P  = 0.011 and  P  = 0.003, respectively), and reduced the incidence of AD exacerbation (11.5% vs. 48.0%,  P  = 0.004) from baseline to week 16. No serious adverse events were observed.
CONCLUSIONS


The intramuscular administration of autologous total IgG provided clinical improvements and a systemic immunomodulatory effect in adolescent and adult patients with moderate-to-severe AD without significant side effects.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0001597.",2020,"The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (-64.8% vs. -20.3%,  P  < 0.001), reduced the affected body surface area (-53.9% vs. -19.1%,  P  < 0.001), improved the DLQI score (-35.4% vs. -14.4%,  P  = 0.015), increased serum interleukin-10 and interferon-γ levels ( P  ","['patients with AD through immune modulation', '51 adolescent and adult patients with moderate-to-severe AD', 'adolescent and adult patients with moderate-to-severe AD', 'patients with AD', 'patients with atopic dermatitis (AD', 'Atopic Dermatitis']","['Autologous Total Immunoglobulin G', 'autologous total IgG', 'autologous total IgG 50 mg (n = 26) or saline', 'placebo', 'autologous total immunoglobulin G (IgG']","['efficacy, safety, and immunomodulatory effect', 'clinical severity score', 'clinical severity score (Eczema Area and Severity Index), affected body surface area, patient-reported Dermatology Life Quality Index (DLQI) score, laboratory biomarkers, and incidence of adverse events', 'DLQI score', 'Efficacy, Safety, and Immunomodulatory Effect', 'affected body surface area', 'serum interleukin-10 and interferon-γ levels', 'incidence of AD exacerbation', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",51.0,0.470745,"The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (-64.8% vs. -20.3%,  P  < 0.001), reduced the affected body surface area (-53.9% vs. -19.1%,  P  < 0.001), improved the DLQI score (-35.4% vs. -14.4%,  P  = 0.015), increased serum interleukin-10 and interferon-γ levels ( P  ","[{'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Nahm', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea. dhnahm@ajou.ac.kr.'}, {'ForeName': 'Young Min', 'Initials': 'YM', 'LastName': 'Ye', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Yoo Seob', 'Initials': 'YS', 'LastName': 'Shin', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Hae Sim', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Myoung Eun', 'Initials': 'ME', 'LastName': 'Kim', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Byul', 'Initials': 'B', 'LastName': 'Kwon', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Su Mi', 'Initials': 'SM', 'LastName': 'Cho', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jinjoo', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Office of Biostatistics, Institute of Medical Sciences, Ajou University School of Medicine, Suwon, Korea.'}]","Allergy, asthma & immunology research",['10.4168/aair.2020.12.6.949']
2875,32939597,Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls.,"RATIONALE


The mechanisms underlying impaired sleep quality in insomnia are not fully known, but an important role for sleep fragmentation has been proposed.
OBJECTIVES


The aim of this study is to explore potential mechanisms of sleep fragmentation influencing alterations of perceived sleep quality.
METHODS


We analyzed polysomnography (PSG) recordings from a double-blind crossover study with zopiclone 7.5 mg and placebo, in elderly participants with insomnia complaints and age-matched healthy controls. We compared survival dynamics of sleep and wake across group and treatment. Subsequently, we used a previously proposed model to estimate the amount of sleep onset latency (SOL) misperception from PSG-defined sleep fragmentation. Self-reported and model-estimated amount of SOL misperception were compared across group and treatment, as well as model prediction errors.
RESULTS


In the zopiclone night, the average segment length of NREM sleep was increased (group F = 1.16, p = 0.32; treatment F = 8.89, p < 0.01; group x treatment F = 0.44, p = 0.65), while the segment length of wake was decreased (group F = 1.48, p = 0.23; treatment F = 11.49, p < 0.01; group x treatment F = 0.36, p = 0.70). The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55). The prediction error was not altered (group F = 1.62, p = 0.20; treatment F = 0.20, p = 0.65; group x treatment F = 1.01, p = 0.37).
CONCLUSIONS


Impaired subjective sleep quality is associated with decreased NREM stability, together with increased stability of wake. Furthermore, we conclude that zopiclone-induced changes in SOL misperception can be largely attributed to predictable changes of sleep architecture.",2020,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","['people with insomnia and healthy controls', 'elderly participants with insomnia complaints and age-matched healthy controls']","['zopiclone 7.5 mg and placebo', 'placebo-controlled pharmacological intervention']","['survival dynamics of sleep', 'SOL misperception', 'segment length of wake', 'average segment length of NREM sleep']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1128536', 'cui_str': 'zopiclone 7.5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]",,0.024048,"The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p < 0.01, treatment F = 10.8, p < 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p < 0.001, group x treatment F = 0.60, p = 0.55).","[{'ForeName': 'Lieke W A', 'Initials': 'LWA', 'LastName': 'Hermans', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands. l.w.a.hermans@tue.nl.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Regis', 'Affiliation': 'Department of Mathematics and Computer Science, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fonseca', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Overeem', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}, {'ForeName': 'Tim R M', 'Initials': 'TRM', 'LastName': 'Leufkens', 'Affiliation': 'Philips Research, High Tech Campus 34, Eindhoven, The Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Vermeeren', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, Maastricht, The Netherlands.'}, {'ForeName': 'Merel M', 'Initials': 'MM', 'LastName': 'van Gilst', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, De Zaale, Eindhoven, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05660-3']
2876,32939617,Impact of a 12-Week Group-Based Compassion Focused Therapy Intervention on Heart Rate Variability.,"Heart rate variability (HRV) is considered an index of self-regulatory capacity, and trait compassion predicts healthy HRV and self-regulation. Compassion focused psychotherapy interventions have been shown to increase levels of compassion in the general population but no studies to date have examined if these interventions also increase HRV in a distressed clinical sample. The present study examined whether a 12-week compassion focused therapy intervention administered in group format would improve resting HRV and impact HRV reactivity during self-critical writing and self-compassion writing tasks administered before and after the intervention. A total of 31 participants in a university counseling center completed the intervention and HRV assessments. Resting HRV did not significantly change over the course of the intervention in the overall sample. Only those who showed a reliable increase in self-compassion also had a significant increase in resting HRV post-intervention. Additionally, the self-critical writing task was associated with a significant decrease in HRV, with HRV staying low during self-compassionate writing and then significantly increasing during recovery. Reliable change in self-compassion predicted increased HRV reactivity to self-critical and self-compassion writing tasks following the intervention, indicating greater engagement with the task. Findings support the idea that increased self-compassion increases HRV reactivity and potentially strengthens ability to engage with difficult emotions in psychotherapy.",2020,Only those who showed a reliable increase in self-compassion also had a significant increase in resting HRV post-intervention.,['31 participants in a university counseling center completed the intervention and HRV assessments'],"['12-Week Group-Based Compassion Focused Therapy Intervention', 'psychotherapy interventions']","['HRV reactivity to self-critical and self-compassion writing tasks', 'HRV, with HRV staying low during self-compassionate writing', 'resting HRV and impact HRV reactivity', 'Heart Rate Variability', 'Heart rate variability (HRV', 'self-compassion']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",31.0,0.029104,Only those who showed a reliable increase in self-compassion also had a significant increase in resting HRV post-intervention.,"[{'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Steffen', 'Affiliation': 'Brigham Young University, 284 TLRB, Provo, UT, 84604, USA. steffen@byu.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Foxx', 'Affiliation': 'Brigham Young University, 284 TLRB, Provo, UT, 84604, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Cattani', 'Affiliation': 'Brigham Young University, 284 TLRB, Provo, UT, 84604, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Alldredge', 'Affiliation': 'Brigham Young University, 284 TLRB, Provo, UT, 84604, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Austin', 'Affiliation': 'Brigham Young University, 284 TLRB, Provo, UT, 84604, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Burlingame', 'Affiliation': 'Brigham Young University, 284 TLRB, Provo, UT, 84604, USA.'}]",Applied psychophysiology and biofeedback,['10.1007/s10484-020-09487-8']
2877,32939747,"Short-Term Steady-State Pattern Electroretinography Changes Using a Multi-Pressure Dial in Ocular Hypertensive, Glaucoma Suspect, and Mild Open-Angle Glaucoma Patients: A Randomized, Controlled, Prospective, Pilot Study.","INTRODUCTION


This study evaluates the effects of the multi-pressure dial (MPD) on steady-state pattern electroretinography (ss-pERG) parameters. The study is a randomized, controlled, prospective, pilot trial in a private practice setting with ocular hypertensive (OHT), glaucoma suspect, and open-angle glaucoma (OAG) subjects.
METHODS


This study included nine patients (64 ± 9.0 years, nine female) with OHT, glaucoma suspect, or mild OAG. One eye of each subject was randomized to receive negative periocular pressure, while the contralateral eye served as the intrasubject control through the goggle without negative pressure. The Diopsys High Contrast Sensitivity ss-pERG protocol was conducted on both eyes of each subject while wearing the MPD device. Application of negative periocular pressure was set at 50% of baseline intraocular pressure for each study eye.
RESULTS


Following 2 h of negative periocular pressure application, the difference in MagnitudeD (MagD) from baseline for eyes randomized to receive negative periocular pressure (+ 0.17 versus  - 0.26) was statistically significant (p = 0.023). Over the same period, the change in MagD/Magnitude (MagD/Mag ratio) from baseline for eyes randomized to receive negative periocular pressure was also higher (+ 0.14 versus  - 0.16), compared to the control eyes, approached significance (p = 0.059).
CONCLUSIONS


Following 2 h of MPD wear, the measured MagD and MagD/Mag ratio improved compared to control, suggesting that negative periocular pressure application to the anterior globe can lead to short-term improvement in one measure of retinal ganglion cell function.",2020,"Mag ratio) from baseline for eyes randomized to receive negative periocular pressure was also higher (+ 0.14 versus  - 0.16), compared to the control eyes, approached significance (p = 0.059).
","['private practice setting with ocular hypertensive (OHT), glaucoma suspect, and open-angle glaucoma (OAG) subjects', 'Ocular Hypertensive, Glaucoma Suspect, and Mild Open-Angle Glaucoma Patients', 'nine patients (64\u2009±\u20099.0\xa0years, nine female) with OHT, glaucoma suspect, or mild OAG']","['multi-pressure dial (MPD', 'Short-Term Steady-State Pattern Electroretinography Changes Using a Multi-Pressure Dial']","['MagD and MagD', 'MagnitudeD (MagD', 'change in MagD/Magnitude (MagD', 'retinal ganglion cell function', 'Mag ratio', 'steady-state pattern electroretinography (ss-pERG) parameters']","[{'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0017614', 'cui_str': 'Glaucoma suspect'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0430848', 'cui_str': 'Steady state pattern electroretinography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0129439', 'cui_str': 'Myelin associate glycoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0430848', 'cui_str': 'Steady state pattern electroretinography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",9.0,0.0310285,"Mag ratio) from baseline for eyes randomized to receive negative periocular pressure was also higher (+ 0.14 versus  - 0.16), compared to the control eyes, approached significance (p = 0.059).
","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Kudrna', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, PA, USA. jkudrna@pennstatehealth.psu.edu.'}, {'ForeName': 'Tanner J', 'Initials': 'TJ', 'LastName': 'Ferguson', 'Affiliation': 'Cole Eye Institute, Cleveland, OH, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Swan', 'Affiliation': 'Vance Thompson Vision, Bozeman, MT, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ferguson', 'Affiliation': 'Dunes Eye Consultants, Dakota Dunes, SD, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Baartman', 'Affiliation': 'Vance Thompson Vision, Omaha, NE, USA.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Bleeker', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, SD, USA.'}, {'ForeName': 'Ramu G', 'Initials': 'RG', 'LastName': 'Sudhagoni', 'Affiliation': 'HemoSonics, LLC, Charlottesville, VA, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Berdahl', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Greenwood', 'Affiliation': 'Vance Thompson Vision, West Fargo, ND, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00302-5']
2878,32939788,Left atrial appendage exclusion is effective in reducing postoperative stroke after mitral valve replacement.,"OBJECTIVE


This study aimed to evaluate the role of surgical left atrial appendage (LAA) exclusion in the prevention of stroke after mitral valve replacement (MVR).
METHODS


We retrospectively reviewed clinical data of 860 patients who received MVR in our center from January 2008 to January 2013. The patients were randomly assigned to two surgical groups, namely LAA exclusion group (n = 521) and LAA nonexclusion group (n = 339) according to whether concurrent surgical exclusion of the LAA was to be undertaken or not before surgery in a blind fashion. MVR was performed by two experienced surgeons. The LAA was explored during the operation and mural thrombus removed in all cases. The LAA was left intact in nonocclusion group whereas the neck of the LAA was closed with a two-layer continued suture in exclusion group. The incidence of early postoperative ischemic stroke between the two groups was compared.
RESULTS


The patients' age was 53 ± 12 years, with 48.1% male and 67.9% with rheumatic disease. Mural thrombosis was seen in 18.8% of the patients and atrial fibrillation (AF) coexisted in 62.4%. All operations were successfully performed and no difference was noted in in-hospital mortality, re-exploration for bleeding, and other major complications between the two groups. The incidence of ischemic stroke in LAA exclusion group was significantly lower than in nonexclusion group (0.6% vs. 2.7%, p = .011). The subgroup multivariate analysis showed that LAA exclusion significantly reduced the risk of postoperative stroke in patients with AF (odds ratio [OR] = 0.070, 95% confidence interval [CI]: 0.006-0.705, p = .025) but not in non-AF patients (OR = 1.902, 95% CI: 0.171-21.191, p = .601).
CONCLUSIONS


Concurrent LAA exclusion during MVR is a safe and effective way to reduce postoperative ischemic stroke, particularly in patients with AF.",2020,"All operations were successfully performed and no difference was noted in in-hospital mortality, re-exploration for bleeding, and other major complications between the two groups.","['860 patients who received MVR in our center from January 2008 to January 2013', 'patients with AF', 'stroke after mitral valve replacement (MVR', ""patients' age was 53\u2009±\u200912 years, with 48.1% male and 67.9% with rheumatic disease""]","['surgical left atrial appendage (LAA) exclusion', 'namely LAA exclusion group (n\u2009=\u2009521) and LAA nonexclusion group']","['postoperative ischemic stroke', 'incidence of early postoperative ischemic stroke', 'hospital mortality, re-exploration for bleeding, and other major complications', 'Mural thrombosis', 'postoperative stroke', 'risk of postoperative stroke', 'incidence of ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1293095', 'cui_str': 'Reexploration procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1260883', 'cui_str': 'Mural thrombus of heart'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0309629,"All operations were successfully performed and no difference was noted in in-hospital mortality, re-exploration for bleeding, and other major complications between the two groups.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiovascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Shixiong', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiovascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Zhiyun', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Cardiovascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Bojun', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, Chinese PLA General Hospital, Beijing, China.'}]",Journal of cardiac surgery,['10.1111/jocs.15020']
2879,32939849,Benefits of perioperative sildenafil therapy in children with a ventricular septal defect with pulmonary artery hypertension on early surgical outcomes.,"OBJECTIVES


Pulmonary hypertension is a common association in children with nonrestrictive ventricular septal defect. It increases perioperative mortality and morbidity. Oral sildenafil is an effective pulmonary vasodilator. In this study, we assessed effects of perioperative oral sildenafil therapy on pulmonary artery pressure and early surgical outcomes.
METHODS


This was a single centre, prospective randomized control study. Thirty children with nonrestrictive ventricular septal defects with pulmonary hypertension were divided into two groups. In the sildenafil group (n = 15, mean age 23.3 months), oral sildenafil was administered two weeks before surgery. In the control group (n = 15, mean age 36 months), preoperative sildenafil was not given. Sildenafil was continued postoperatively in both groups, provided the postoperative pulmonary artery pressure was over 50% of systemic pressure.
RESULTS


There was no perioperative mortality, pulmonary hypertensive crisis and there were no intolerable side effects related to sildenafil in either group. Mean pulmonary artery pressure showed a reduction in both groups. Sildenafil group showed statistically significant improvement in duration of cardiopulmonary bypass (100.27 ± 21.09 min vs. 125.40 ± 26.83 min, p = .008), mechanical ventilation requirement (22.79 ± 17.13 h vs. 30.53 ± 13.05 h; p = .04), epinephrine requirement (22% patients vs. 48% patients; p = .03) and hospital stay (6.13 ± 1.40 days vs. 7.53 ± 1.92 days; p = .05).
CONCLUSION


Oral Sildenafil therapy is an inexpensive and well-tolerated method for reducing pulmonary hypertension secondary to non-restrictive ventricular septal defect. It has noteworthy advantages regarding early surgical outcomes like reduced cardiopulmonary bypass time, improved mechanical ventilation time, lower inotrope requirement and shorter hospital stay if used preoperatively in select patient population.",2020,"There was no perioperative mortality, pulmonary hypertensive crisis and there were no intolerable side effects related to sildenafil in either group.","['children with a ventricular septal defect with pulmonary artery hypertension on early surgical outcomes', 'Thirty children with nonrestrictive ventricular septal defects with pulmonary hypertension', 'children with nonrestrictive ventricular septal defect']","['sildenafil', 'Oral sildenafil', 'Sildenafil therapy', 'perioperative sildenafil therapy', 'oral sildenafil', 'perioperative oral sildenafil therapy', 'Sildenafil', 'preoperative sildenafil']","['hospital stay', 'duration of cardiopulmonary bypass', 'mechanical ventilation time, lower inotrope requirement and shorter hospital stay', 'intolerable side effects', 'mechanical ventilation requirement', 'postoperative pulmonary artery pressure', 'Mean pulmonary artery pressure', 'epinephrine requirement', 'perioperative mortality, pulmonary hypertensive crisis', 'pulmonary artery pressure and early surgical outcomes', 'perioperative mortality and morbidity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018818', 'cui_str': 'Ventricular septal defect'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2363966', 'cui_str': 'Pulmonary hypertensive crisis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",30.0,0.0252546,"There was no perioperative mortality, pulmonary hypertensive crisis and there were no intolerable side effects related to sildenafil in either group.","[{'ForeName': 'Ruchit', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shyam Kumar Singh', 'Initials': 'SKS', 'LastName': 'Thingnam', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Anand Kumar', 'Initials': 'AK', 'LastName': 'Mishra', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Rohit', 'Affiliation': 'Department of Cardiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Upadhyay', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Halder', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vidur', 'Initials': 'V', 'LastName': 'Bansal', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Journal of cardiac surgery,['10.1111/jocs.15030']
2880,32939850,Induction of labor with a Foley catheter and the risk of subsequent preterm birth: A follow-up study of two randomized controlled trials (PROBAAT-1 and -2).,"OBJECTIVE


The objective of this study was to evaluate the preterm birth rate in a subsequent pregnancy in women who had undergone term induction with a Foley catheter in comparison to induction with prostaglandins.
METHODS


This was a follow-up study of two large randomized controlled trials. In the original trials (PROBAAT-1 and PROBAAT-2), women with a term, singleton pregnancy in cephalic presentation with an indication for labor induction were randomized to either a 30cc Foley catheter or prostaglandins (i.e. vaginal prostaglandin E2 in PROBAAT 1 and oral misoprostol in PROBAAT 2). The main outcome measures were preterm birth <37 weeks gestation and preterm birth <34 weeks gestation. Data were collected from hospital charts on subsequent pregnancies from hospitals participating in this follow-up study.
RESULTS


14 hospitals agreed to participate in this follow-up study. Of the 1142 eligible women, 162 women (14%) were lost to follow-up. Of the 572 women randomized to a Foley catheter, 251 women had a subsequent pregnancy beyond 16 weeks gestation, versus 258 women of the 570 women who received prostaglandins. There were no differences in baseline characteristics. The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93; 95%CI 0.38-2.24), with spontaneous preterm birth rates of 5/251 (2.0%) versus 5/258 (1.9%) respectively (RR 1.03, 95%CI 0.30-3.51).
CONCLUSIONS


In women with a singleton term pregnancy, induction of labor with a 30cc Foley catheter is not associated with an increased risk of preterm birth in a subsequent pregnancy as compared to induction of labor with prostaglandins. This article is protected by copyright. All rights reserved.",2020,The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93;,"['1142 eligible women, 162 women (14%) were lost to follow-up', '572 women randomized to a Foley catheter, 251 women had a subsequent pregnancy beyond 16 weeks gestation, versus 258 women of the 570 women who received', 'women with a term, singleton pregnancy in cephalic presentation with an indication for labor induction', 'women who had undergone term induction with a Foley catheter in comparison to induction with prostaglandins']","['30cc Foley catheter or prostaglandins (i.e. vaginal prostaglandin E2 in PROBAAT 1 and oral misoprostol', 'prostaglandins', 'labor with a Foley catheter', 'prostaglandin']","['risk of subsequent preterm birth', 'overall preterm birth rate', 'preterm birth <37 weeks gestation and preterm birth <34 weeks gestation', 'preterm birth rate', 'risk of preterm birth', 'spontaneous preterm birth rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",1142.0,0.412941,The overall preterm birth rate was 9/251 (3.6%) in the Foley catheter group versus 10/258 (3.9%) in the prostaglandin group (RR 0.93;,"[{'ForeName': 'M D T', 'Initials': 'MDT', 'LastName': 'de Vaan', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'K W M', 'Initials': 'KWM', 'LastName': 'Bloemenkamp', 'Affiliation': ""Department of Obstetrics, Division Woman and Baby, Wilhelmina Children's Hospital Birth Centre, University Medical Centre Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jozwiak', 'Affiliation': 'Department of Gynaecologic Oncology, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'M L G', 'Initials': 'MLG', 'LastName': 'Ten Eikelder', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal Cornwall Hospital NHS trust, Princess Alexandra Wing, Truro, UK.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Department of Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'J J H', 'Initials': 'JJH', 'LastName': 'Bakker', 'Affiliation': 'Department of Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'R J P', 'Initials': 'RJP', 'LastName': 'Rijnders', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Papatsonis', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amphia Hospital, Breda, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Woiski', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Heus', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ikazia Hospital, Rotterdam, the Netherlands.'}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.23117']
2881,32939858,Gait Biofeedback and Impairment-based Rehabilitation for Chronic Ankle Instability.,"Our purpose was to analyze the effects of 4-weeks of visual gait biofeedback (GBF) and impairment-based rehabilitation on gait biomechanics and patient-reported outcomes (PROs) in individuals with chronic ankle instability (CAI). Twenty-seven individuals with CAI participated in this randomized controlled trial (14 received no biofeedback (NBF), 13 received GBF). Both groups received 8-sessions of impairment-based rehabilitation. The GBF group received visual biofeedback to reduce ankle frontal plane angle at initial contact (IC) during treadmill walking. The NBF group walked for equal time during rehabilitation but without biofeedback. Dependent variables included three-dimensional kinematics and kinetics at the ankle, knee, and hip, electromyography amplitudes of 4 lower extremity muscles (tibialis anterior, fibularis longus, medial gastrocnemius, gluteus medius), and PROs (Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL), FAAM-Sport, Tampa Scale of Kinesiophobia (TSK), and Global Rating of Change (GROC)). The GBF group significantly decreased ankle inversion at IC (MD:-7.3º, g=1.6) and throughout the entire stride cycle (peak inversion: MD:-5.9º, g=1.2). The NBF group did not have significantly altered gait biomechanics. The groups were significantly different after rehabilitation for the FAAM-ADL (GBF:97.1±2.3%, NBF: 92.0±5.7%), TSK (GBF:29.7±3.7, NBF:34.9±5.8), and GROC (GBF:5.5±1.0, NBF:3.9±2.0) with the GBF group showing greater improvements than the NBF group. There were no significant differences between groups for kinetics or electromyography measures. The GBF group successfully decreased ankle inversion angle and had greater improvements in PROs after intervention compared to the NBF group. Impairment-based rehabilitation combined with visual biofeedback during gait training is recommended for individuals with CAI.",2020,The GBF group successfully decreased ankle inversion angle and had greater improvements in PROs after intervention compared to the NBF group.,"['individuals with CAI', 'individuals with chronic ankle instability (CAI', 'Chronic Ankle Instability', 'Twenty-seven individuals with CAI']","['visual biofeedback', 'Gait Biofeedback and Impairment-based Rehabilitation', '8-sessions of impairment-based rehabilitation', 'no biofeedback (NBF), 13 received GBF', 'Impairment-based rehabilitation combined with visual biofeedback during gait training', 'GBF', 'NBF', 'visual gait biofeedback (GBF) and impairment-based rehabilitation']","['ankle inversion angle', 'PROs', 'FAAM-ADL', 'gait biomechanics', 'ankle inversion', 'dimensional kinematics and kinetics at the ankle, knee, and hip, electromyography amplitudes of 4 lower extremity muscles (tibialis anterior, fibularis longus, medial gastrocnemius, gluteus medius), and PROs (Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL), FAAM-Sport, Tampa Scale of Kinesiophobia (TSK), and Global Rating of Change (GROC', 'kinetics or electromyography measures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C4319602', 'cui_str': '27'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0224469', 'cui_str': 'Peroneus longus muscle structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0224425', 'cui_str': 'Structure of gluteus medius muscle'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",27.0,0.0312353,The GBF group successfully decreased ankle inversion angle and had greater improvements in PROs after intervention compared to the NBF group.,"[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Koldenhoven', 'Affiliation': 'Texas State University, Department of Health and Human Performance, San Marcos, TX, USA, 78666-4616.'}, {'ForeName': 'Abbis H', 'Initials': 'AH', 'LastName': 'Jaffri', 'Affiliation': 'Creighton University, Department of Physical Therapy, Omaha, NE, USA, 68178.'}, {'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'DeJong', 'Affiliation': 'University of Virginia, Department of Kinesiology, Charlottesville, VA, USA, 22904-4407.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abel', 'Affiliation': 'Creighton University, Department of Physical Therapy, Omaha, NE, USA, 68178.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Hart', 'Affiliation': 'University of Virginia, Department of Kinesiology, Charlottesville, VA, USA, 22904-4407.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Saliba', 'Affiliation': 'University of Virginia, Department of Kinesiology, Charlottesville, VA, USA, 22904-4407.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'University of Virginia, Department of Kinesiology, Charlottesville, VA, USA, 22904-4407.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13823']
2882,32939860,"A phase 4, randomised, head-to-head trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate-to-severe plaque psoriasis (CHANGE).","BACKGROUND


Brodalumab is a fully human monoclonal immunoglobulin IgG2 antibody that binds to the human IL-17 receptor subunit A and by that inhibits the biologic action of IL-17A, 17F, 17C, and 17E. Therapy with fumaric acid esters (FAE) is a well-established and widely used first-line systemic treatment for subjects with moderate-to-severe plaque psoriasis OBJECTIVES: To compare brodalumab to FAE in terms of clinical efficacy, patient-reported outcomes, and safety in subjects with moderate to severe plaque psoriasis who were naïve to systemic treatment.
METHODS


Eligible subjects were randomised 1:1 to 210 mg brodalumab injections or oral FAE according to product label in this 24-week, open-label, assessor-blinded, multi-centre, head-to-head phase 4 trial. The primary endpoints were having PASI75 and having sPGA score of 0 or 1 (sPGA 0/1). Subjects with missing values for the primary endpoints were considered non-responders.
RESULTS


A total of 210 subjects were randomised. 91/105 subjects completed brodalumab treatment and 58/105 subjects completed FAE treatment. At Week 24, significantly more subjects in the brodalumab group compared to the FAE group had PASI75 (81.0% vs. 38.1%, p<0.001) and sPGA 0/1 (64.8% vs. 20.0%, p<0.001). In the brodalumab group, the median time to both PASI75 and to PASI90 was significantly shorter than in the FAE group (4.1 weeks vs. 16.4 weeks, and 7.4 weeks vs. 24.4 weeks, respectively, p<0.0001 for both). The rate of adverse events was lower in subjects treated with brodalumab compared to subjects treated with FAE (616.4 vs. 1195.8 events per 100 exposure years). No new safety signals were detected for brodalumab.
CONCLUSIONS


Brodalumab was associated with rapid and significant improvements in signs and symptoms of moderate-to-severe plaque psoriasis, with a superior efficacy profile to what was observed with FAE in systemic-naïve subjects over 24 weeks.",2020,"In the brodalumab group, the median time to both PASI75 and to PASI90 was significantly shorter than in the FAE group (4.1 weeks vs. 16.4 weeks, and 7.4 weeks vs. 24.4 weeks, respectively, p<0.0001 for both).","['210 subjects', 'adults with moderate-to-severe plaque psoriasis (CHANGE', 'subjects with moderate-to-severe plaque psoriasis', 'subjects with moderate to severe plaque psoriasis who were naïve to systemic treatment', '91/105 subjects completed brodalumab treatment and 58/105 subjects completed FAE treatment', 'Eligible subjects']","['FAE', 'brodalumab to oral administrations of fumaric acid esters', 'brodalumab injections or oral FAE']","['median time to both PASI75 and to PASI90', 'PASI75', 'rate of adverse events', 'having PASI75 and having sPGA score of 0 or 1 (sPGA 0/1']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}]","[{'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}, {'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",210.0,0.0542731,"In the brodalumab group, the median time to both PASI75 and to PASI90 was significantly shorter than in the FAE group (4.1 weeks vs. 16.4 weeks, and 7.4 weeks vs. 24.4 weeks, respectively, p<0.0001 for both).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Dept. of Dermatology, Venereology and Allergology, Clinical Research Division, University of Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Dermatological Practice, Witten, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'German Center for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kaplan', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Gudjónsdóttir', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delvin', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis Center at the Dept. of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16932']
2883,32939934,Comparison of the accuracy of implant position for two-implants supported fixed dental prosthesis using static and dynamic computer-assisted implant surgery: A randomized controlled clinical trial.,"BACKGROUND


Computer-assisted implant surgery (CAIS) can facilitate accuracy of single implant placement, but little is known with regards to parallelism between multiple implants.
PURPOSE


To compare the accuracy of position and parallelism of two implants, using static and dynamic CAIS systems.
MATERIALS AND METHODS


Thirty patients received two implants (60 implants) randomly allocated to two different CAIS systems. Optimal implant position and absolute parallelism was planned based on preoperative cone beam CT (CBCT). Patients received implants with a surgical guide (static CAIS, n = 30) or real-time navigation (dynamic CAIS, n = 30). Implant three-dimensional deviation and parallelism was calculated after surgery.
RESULTS


The mean 3D deviation in the static and dynamic CAIS group at implant platform were 1.04 ± 0.67 vs 1.24 ± 0.39 mm, at apex were 1.54 ± 0.79 vs 1.58 ± 0.56 mm and angulation were 4.08° ± 1.69° vs 3.78° ± 1.84°, respectively. The angle deviations between two placed implants (parallelism) in static and dynamic CAIS groups were 4.32° ± 2.44° and 3.55° ± 2.29°, respectively. There were no statistically significant differences in all parameters between groups.
CONCLUSION


Static and dynamic CAIS provides similar accuracy of the 3D implant position and parallelism between two implants.",2020,"There were no statistically significant differences in all parameters between groups.
",['Thirty patients received two implants (60 implants) randomly allocated to two different CAIS systems'],"['Computer-assisted implant surgery (CAIS', 'implants with a surgical guide (static CAIS, n = 30) or real-time navigation', 'Static and dynamic CAIS', 'fixed dental prosthesis using static and dynamic computer-assisted implant surgery']",['mean 3D deviation'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]",,0.0590674,"There were no statistically significant differences in all parameters between groups.
","[{'ForeName': 'Paweena', 'Initials': 'P', 'LastName': 'Yimarj', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Keskanya', 'Initials': 'K', 'LastName': 'Subbalekha', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kanit', 'Initials': 'K', 'LastName': 'Dhanesuan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Kiti', 'Initials': 'K', 'LastName': 'Siriwatana', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Mattheos', 'Affiliation': 'Implant Dentistry, Oral Rehabilitation, Faculty of Dentistry of the University of Hong Kong, Prince Philip Dental Hospital, Hong Kong, China.'}, {'ForeName': 'Atiphan', 'Initials': 'A', 'LastName': 'Pimkhaokham', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}]",Clinical implant dentistry and related research,['10.1111/cid.12949']
2884,32940092,Effect of laparoscopic surgery for colorectal cancer with N. O. S. E. on recovery and prognosis of patients.,"OBJECTIVE


To investigate the effect of laparoscopic surgery in colorectal cancer (CRC) patients with natural orifice specimen extraction (NOSE) on the recovery and quality of life (QOL) of patients.
MATERIAL AND METHODS


Ninety-two eligible patients were randomly assigned into two groups: the traditional laparoscopy group (L group,  n  = 46) and the laparoscopic transanal specimen extraction group (NL group,  n  = 46). General data, surgery-related indicators, postoperative recovery, and prognosis were compared and analyzed between the two groups.
RESULTS


A total of 46 patients in each group were enrolled in this study. The general data and surgery-related indicators were comparable between the two groups (all  p >  .05). There were no significant differences in the time of first flatus, bleeding, obstruction, constipation, and infectious complications between the two groups (all  p >  .05). The differences in the incidence of postoperative diarrhea, pain degree, and satisfaction on the aesthetics of the abdominal wall showed significant differences (χ 2  = 6.133,  p =  .013; χ 2  = 12.116,  p =  .017; χ 2  = 13.463,  p =  .004). The postoperative follow-up time was 3-53 months. There were no significant differences in the postoperative hospital stay, medical costs, hospital readmission rate, incidence of incisional hernia, overall survival, disease-free survival, and QOL between the two groups (all  p >  .05). Conclusion: Laparoscopic surgery with NOSE for eligible patients with CRC was a feasible choice.",2020,"There were no significant differences in the postoperative hospital stay, medical costs, hospital readmission rate, incidence of incisional hernia, overall survival, disease-free survival, and QOL between the two groups (all  p >  .05).","['eligible patients with CRC', 'colorectal cancer (CRC) patients with natural orifice specimen extraction (NOSE', '46 patients in each group were enrolled in this study', 'Ninety-two eligible patients']","['traditional laparoscopy group (L group,  n \u2009=\u200946) and the laparoscopic transanal specimen extraction group (NL group,  n \u2009=\u200946', 'Laparoscopic surgery with NOSE', 'laparoscopic surgery']","['recovery and quality of life (QOL', 'postoperative diarrhea, pain degree, and satisfaction on the aesthetics of the abdominal', 'postoperative hospital stay, medical costs, hospital readmission rate, incidence of incisional hernia, overall survival, disease-free survival, and QOL', 'time of first flatus, bleeding, obstruction, constipation, and infectious complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0854525', 'cui_str': 'Post surgical diarrhea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",92.0,0.0650841,"There were no significant differences in the postoperative hospital stay, medical costs, hospital readmission rate, incidence of incisional hernia, overall survival, disease-free survival, and QOL between the two groups (all  p >  .05).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Bu', 'Affiliation': ""Department of General Surgery, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Department of General Surgery, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of General Surgery, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Heng-Yi', 'Initials': 'HY', 'LastName': 'Deng', 'Affiliation': ""Department of General Surgery, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': ""Department of General Surgery, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Hong-Jun', 'Initials': 'HJ', 'LastName': 'Yuan', 'Affiliation': ""Department of General Surgery, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Chuan-Ming', 'Initials': 'CM', 'LastName': 'Zhang', 'Affiliation': ""Department of Digestive Medicine, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': ""Department of Digestive Medicine, Chengdu second people's Hospital, Chengdu, China.""}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Surgery Center, West China Hospital, Sichuan University, Chengdu, China.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2020.1799410']
2885,32940131,The Effect of One Session Split-Belt Treadmill Training on Gait Adaptation in People With Parkinson's Disease and Freezing of Gait.,"BACKGROUND


Freezing of gait (FOG) in Parkinson's disease (PD) is associated with gait asymmetry and switching difficulty. A split-belt treadmill may potentially address those deficits.
OBJECTIVE


To investigate the immediate and retention effects of one-session split-belt treadmill training (SBT) in contrast to regular tied-belt treadmill training (TBT) on gait asymmetry and adaptation in people with PD and FOG (PD + FOG) and healthy controls (HC). Additionally, to investigate differential effects of 3 SBT protocols and compare different gait adaptation outcomes.
METHODS


PD + FOG (n = 45) and HC (n = 36) were randomized to 1 of 3 SBT groups (belt speeds' ratio 0.75:1; 0.5:1 or changing ratios) or TBT group. Participants were tested at Pre, Post, and Retention after one treadmill training session. Gait asymmetry was measured during a standardized adaptation test on the split-belt treadmill.
RESULTS


SBT proved beneficial for gait adaptation in PD + FOG and HC ( P  < .0001); however, HC improved more. SBT with changing ratios demonstrated significant effects on gait adaptation from Pre to Post in PD + FOG, supported by strong effect sizes ( d  = 1.14) and improvements being retained for 24 hours. Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P  = .035) and differentiated best between the groups.
CONCLUSIONS


PD + FOG improved gait adaptation after a single SBT session although effects were smaller than in HC. SBT with changing ratios was the most effective to ameliorate gait adaptation in PD + FOG. These promising results warrant future study on whether long-term SBT strengthens adaptation in PD + FOG and has potential to induce a better resilience to FOG. Clinical trial ID: NCT03725215.",2020,"Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P  = .035) and differentiated best between the groups.
","[""Parkinson's disease (PD"", 'people with PD and FOG (PD + FOG) and healthy controls (HC', ""People With Parkinson's Disease and Freezing of Gait"", 'PD + FOG (n = 45) and HC (n = 36']","['PD + FOG', 'regular tied-belt treadmill training (TBT', 'TBT', 'session split-belt treadmill training (SBT', 'One Session Split-Belt Treadmill Training']","['Gait Adaptation', 'Mean step length asymmetry during initial exposure', 'Gait asymmetry', 'gait adaptation', 'gait adaptation in PD + FOG and HC']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",36.0,0.0330414,"Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P  = .035) and differentiated best between the groups.
","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Seuthe', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': ""D'Cruz"", 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Ginis', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Jos Steffen', 'Initials': 'JS', 'LastName': 'Becktepe', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Weisser', 'Affiliation': 'Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schlenstedt', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320953144']
2886,32940132,Skin closure following abdominal wall reconstruction: three-layer skin suture versus staples.,"Skin closure following abdominal wall reconstruction (AWR) has received little attention, even though these patients have demonstrated insufficient wound healing. This study assessed the postoperative wound-related complications and patient-reported outcomes after skin closure using single- or triple layer closure following AWR. This was a retrospective study at a University Hospital from 2016 to 2018. Patients were grouped into a single-layer cohort (SLC) and a triple-layer cohort (TLC). Skin incisions closed with either technique were compared. Postoperative complications were registered from chart review (SLC:  n  = 48, TLC:  n  = 40). Patient reported-outcomes were assessed through the Patient Scar Assessment Questionnaire (PSAQ) and the Hernia Related Quality of Life survey. A total of 51 patients were included (SLC:  n  = 26, TLC:  n  = 25). There was no difference in wound complications after single- or triple-layer skin closure; seroma (SLC: 16.7% vs. TLC: 15%,  p  = 1.00), surgical site infection (SLC: 4.2% vs. TLC: 7.5%,  p  = .834), hematoma (SLC: 6.2% vs. TLC: 2.5%,  p  = .744) and wound rupture (SLC: 2.1% vs. TLC: 2.5%,  p  = 1.00). Patients who had incisions closed using single-layer closure were more satisfied; PSAQ satisfaction with scar symptoms (SLC: 6.7 points (IQR 0.0-18.3) vs. TLC: 26.7 points (IQR 0.0-33.3),  p  = .039) and scar aesthetics (SLC 25.9 points (IQR 18.5-33.3) vs. TLC: 37.0 (IQR 29.6-44.4),  p  = .013). There was no difference in 30-day wound complications after either skin closure technique. The results favoured the single-layer closure technique regarding the cosmetic outcome.  Abbreviations:  AWR: abdominal wall reconstruction; SLC: single-layer cohort; TLC: triple-layer cohort; PSAQ: patient scar assessment questionnaire; IH: incisional hernia; QOL: quality of life; BMI: body mass index; HerQLes: hernia-related quality of life; ASA: American Society of Anesthesiologists; SSO: surgical site occurence; SSI: surgical site infection; LOS: length of stay; RCT: randomized controlled trial.",2020,"There was no difference in wound complications after single- or triple-layer skin closure; seroma (SLC: 16.7% vs. TLC: 15%,  p  = 1.00), surgical site infection (SLC: 4.2% vs. TLC: 7.5%,  p  = .834), hematoma (SLC: 6.2% vs. TLC: 2.5%,  p  = .744) and wound rupture (SLC: 2.1% vs. TLC: 2.5%,  p  = 1.00).","['A total of 51 patients were included (SLC:  n \u2009=\u200926, TLC:  n \u2009=\u200925', 'University Hospital from 2016 to 2018']","['Skin closure following abdominal wall reconstruction (AWR', 'single- or triple layer closure following AWR', 'Skin closure following abdominal wall reconstruction: three-layer skin suture versus staples']","['wound complications', 'Patient Scar Assessment Questionnaire (PSAQ) and the Hernia Related Quality of Life survey', 'scar aesthetics', 'wound rupture', 'satisfied; PSAQ satisfaction with scar symptoms', 'Postoperative complications', 'surgical site infection', '30-day wound complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1700396', 'cui_str': 'CCL21 protein, human'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C1282402', 'cui_str': 'Skin layer'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021501', 'cui_str': 'wounds'}]",51.0,0.0907272,"There was no difference in wound complications after single- or triple-layer skin closure; seroma (SLC: 16.7% vs. TLC: 15%,  p  = 1.00), surgical site infection (SLC: 4.2% vs. TLC: 7.5%,  p  = .834), hematoma (SLC: 6.2% vs. TLC: 2.5%,  p  = .744) and wound rupture (SLC: 2.1% vs. TLC: 2.5%,  p  = 1.00).","[{'ForeName': 'F J L', 'Initials': 'FJL', 'LastName': 'Gaspar', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hensler', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Vester-Glowinski', 'Affiliation': 'Department of Plastic Surgery and Burns Treatment, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Jensen', 'Affiliation': 'Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of plastic surgery and hand surgery,['10.1080/2000656X.2020.1815754']
2887,32940234,Evaluating the Ability of Economic Models of Diabetes to Simulate New Cardiovascular Outcomes Trials: A Report on the Ninth Mount Hood Diabetes Challenge.,"OBJECTIVES


The cardiovascular outcomes challenge examined the predictive accuracy of 10 diabetes models in estimating hard outcomes in 2 recent cardiovascular outcomes trials (CVOTs) and whether recalibration can be used to improve replication.
METHODS


Participating groups were asked to reproduce the results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. Calibration was performed and additional analyses assessed model ability to replicate absolute event rates, hazard ratios (HRs), and the generalizability of calibration across CVOTs within a drug class.
RESULTS


Ten groups submitted results. Models underestimated treatment effects (ie, HRs) using uncalibrated models for both trials. Calibration to the placebo arm of EMPA-REG OUTCOME greatly improved the prediction of event rates in the placebo, but less so in the active comparator arm. Calibrating to both arms of EMPA-REG OUTCOME individually enabled replication of the observed outcomes. Using EMPA-REG OUTCOME-calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately. Applying canagliflozin HRs directly provided the best fit.
CONCLUSIONS


The Ninth Mount Hood Diabetes Challenge demonstrated that commonly used risk equations were generally unable to capture recent CVOT treatment effects but that calibration of the risk equations can improve predictive accuracy. Although calibration serves as a practical approach to improve predictive accuracy for CVOT outcomes, it does not extrapolate generally to other settings, time horizons, and comparators. New methods and/or new risk equations for capturing these CV benefits are needed.",2020,Using EMPA-REG OUTCOME-calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately.,['Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program'],['placebo'],['prediction of event rates'],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0527189,Using EMPA-REG OUTCOME-calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Kensington, Australia; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Willis', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Asseburg', 'Affiliation': 'ESiOR Oy, Kuopio, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'The Swedish Institute for Health Economics, Lund, Sweden.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tew', 'Affiliation': 'Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Clarke', 'Affiliation': 'Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Victoria, Australia; Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lamotte', 'Affiliation': 'Global Health Economics and Outcomes Research, IQVIA, Zaventem, Belgium.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'Global Health Economics and Outcomes Research, IQVIA, Lisbon, Portugal.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Global Health Management and Policy, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, United Kingdom.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Herman', 'Affiliation': 'Departments of Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Shihchen', 'Initials': 'S', 'LastName': 'Kuo', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Deanna J', 'Initials': 'DJ', 'LastName': 'Isaman', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Wendelin', 'Initials': 'W', 'LastName': 'Schramm', 'Affiliation': 'Centre for Health Economics and Outcomes Research, GECKO Institute, Heilbronn University, Heilbronn, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Sailer', 'Affiliation': 'Centre for Health Economics and Outcomes Research, GECKO Institute, Heilbronn University, Heilbronn, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brennan', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pollard', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Smolen', 'Affiliation': 'Medical Decision Modeling Inc., Indianapolis, Indiana, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Talitha', 'Initials': 'T', 'LastName': 'Feenstra', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands; University of Groningen, Faculty of Science and Engineering, Groningen, The Netherlands.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Palmer', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Victoria, Australia. Electronic address: andrew.palmer@utas.edu.au.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.04.1832']
2888,32940419,"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo-controlled clinical trial.","INTRODUCTION


Effective insomnia interventions that also address autonomic dysregulation are lacking. We evaluate high-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM ®  ), in a randomized, controlled clinical trial. HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology, to support self-optimization of brain rhythms.
METHODS


One hundred and seven adults (mean age 45.7, SD ± 5.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90-min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or random tones not linked to brainwaves (NL, 51), as an active, sham placebo. Outcomes were obtained at enrollment (V1), 1-7 days (V2), 8-10 weeks (V3), and 16-18 weeks (V4) after intervention. Primary outcome was differential change in ISI from V1 to V3. Secondary measures assessed depression (BDI), anxiety (BAI), quality of life (EQ-5D), and a sleep diary. Ten minute recordings of HR and BP allowed analysis of heart rate variability (HRV) and baroreflex sensitivity (BRS).
RESULTS


Of 107 randomized, 101 completed the intervention. Intention-to-treat analysis (107) of change from V1 to V3 revealed a mean reduction of ISI in NL of -4.93 (SE ± 0.76) points, with additional, significant reduction of -2.05 points (0.74) in LB (total reduction of -6.98, p = .045). Additional reduction of -2.30 points (0.76) was still present in the LB at V4 (p = .058). Total ISI reduction from V1 to V4 was -5.90 points for NL and -7.93 points in LB. There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency. There were no serious adverse events.
CONCLUSIONS


Results of this controlled clinical trial showed clinically relevant reduction of insomnia symptoms with HIRREM, over, and above an active, sham control, with associated, durable improvement in autonomic cardiovascular regulation.",2020,"There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency.","['One hundred and seven adults (mean age 45.7, SD\xa0±\xa05.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90-min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or', 'insomnia', 'Of 107 randomized']","['placebo', 'electroencephalic mirroring (HIRREM', 'random tones not linked to brainwaves (NL, 51), as an active, sham placebo']","['differential change in ISI', 'autonomic cardiovascular regulation', 'multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency', 'heart rate variability (HRV) and baroreflex sensitivity (BRS', 'Total ISI reduction', 'depression (BDI), anxiety (BAI), quality of life (EQ-5D), and a sleep diary']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0678909', 'cui_str': 'Brainwaves'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0678909', 'cui_str': 'Brainwaves'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",107.0,0.243114,"There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency.","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Tegeler', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.'}, {'ForeName': 'Hossam A', 'Initials': 'HA', 'LastName': 'Shaltout', 'Affiliation': 'Hypertension and Vascular Research Center, WFSM, Winston-Salem, NC, USA.'}, {'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'University of Arizona School of Medicine, Phoenix, AZ, USA.'}, {'ForeName': 'Sean L', 'Initials': 'SL', 'LastName': 'Simpson', 'Affiliation': 'Department of Biostatistics and Data Sciences, WFSM, Winston-Salem, NC, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Gerdes', 'Affiliation': 'Brain State Technologies, LLC, Scottsdale, AZ, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Tegeler', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.'}]",Brain and behavior,['10.1002/brb3.1826']
2889,32940428,Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).,"AIMS


The role of non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biometric data and symptom reporting (telemonitoring) combined with VC structured, nurse-based follow-up (teleintervention). The results will be compared with those of the comprehensive HF usual care (UC) strategy based on face-to-face on-site visits at the vulnerable post-discharge phase.
METHODS AND RESULTS


We designed a 24 week nationwide, multicentre, randomized, controlled, open-label, blinded endpoint adjudication trial to assess the effect on cardiovascular (CV) mortality and non-fatal HF events of a TM-based comprehensive management programme, based on mHealth, for patients with chronic HF. Approximately 508 patients with a recent hospital admission due to HF decompensation will be randomized (1:1) to either structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM. The primary outcome will be a composite of death from CV causes or non-fatal HF events (first and recurrent) at the end of a 6 month follow-up period. Key secondary endpoints will include components of the primary event analysis, recurrent event analysis, and patient-reported outcomes.
CONCLUSIONS


The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.",2020,The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.,"['Approximately 508 patients with a recent hospital admission due to HF decompensation', ""patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients"", 'patients with chronic HF']","['TM-based comprehensive management programme', 'non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC', 'structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM', 'Remote Monitoring and eHealth Support (HERMeS']","['components of the primary event analysis, recurrent event analysis, and patient-reported outcomes', 'cardiovascular (CV) mortality and non-fatal HF events', 'composite of death from CV causes or non-fatal HF events (first and recurrent']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011211', 'cui_str': 'Health Care Delivery'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",508.0,0.111182,The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.,"[{'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Yun', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Enjuanes', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calero', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Hidalgo', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Department of Cardiology, Puerta de Hierro Majadahonda University Hospital, Puerta de Hierro-Segovia de Arana Health Research Institute (IDIPHSA), Madrid, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Llàcer', 'Affiliation': 'Department of Internal Medicine, Manises Hospital, Medical Research Institute of Hospital La Fe (IIS La Fe), València, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'García-Pinilla', 'Affiliation': 'Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Carlos III Health Institute (ISCIII), Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'González-Franco', 'Affiliation': 'Department of Internal Medicine, Central de Asturias University Hospital (HUCA), Foundation for Health and Biomedicine Research and Innovation of Asturias (FINBA), Oviedo, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Biomedical Research Networking Center on Cardiovascular Diseases (CIBERCV), Carlos III Health Institute (ISCIII), Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Morales-Rull', 'Affiliation': ""Department of Internal Medicine, Heart Failure Unit, Arnau de Vilanova University Hospital, Lleida Biomedical Research Institute's Dr. Pifarré Foundation (IRBLleida), Lleida, Spain.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Beltrán', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Delso', 'Affiliation': ""Chronic Care Teams, Primary Care Service (SAP) Delta Llobregat, Foundation University Institute for Research in Primary Health Care Jordi Gol i Gurina (IDIAPJGol), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Román', 'Initials': 'R', 'LastName': 'Freixa-Pamias', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Moliner', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Corbella', 'Affiliation': ""Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': ""Community Heart Failure Program, Departments of Cardiology and Internal Medicine, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ESC heart failure,['10.1002/ehf2.12962']
2890,32940568,The effectiveness of a client-centered lifestyle intervention in women with fibromyalgia syndrome: A quasi-experimental controlled study.,"In this study, the authors aimed to investigate the effects of a client-centered lifestyle intervention for women with fibromyalgia syndrome on the levels of disease severity, occupational participation, anxiety, depression, and life satisfaction. The quasi-experimental controlled study was conducted at Occupational Therapy Department of Hacettepe University in Turkey between January 2018 and May 2018. Based on the literature review and basic assessments, a lifestyle intervention program was designed focusing both on the participants' occupational goals and the effects of fibromyalgia symptoms. The results were measured using the Revised Fibromyalgia Impact Questionnaire (FIQR), The Canadian Occupational Performance Measure (COPM), Hospital Anxiety and Depression Scale (HADS), and Satisfaction with Life Scale (SWLS). Significant differences were found in intervention group compared to control in terms of COPM-Performance ( p  = .001), COPM-Satisfaction ( p  = .001), HADS-Anxiety ( p  = .009), and HADS-Depression ( p  = .001). Although FIQR and SWLS levels improved positively in the intervention group (respectively;  p  = .001 and  p  =.012), there was no difference between the groups. According to these results, the client-centered and occupation-based lifestyle intervention applied to individuals with fibromyalgia could be effective on occupational participation and psychological symptoms.",2020,"Significant differences were found in intervention group compared to control in terms of COPM-Performance ( p  = .001), COPM-Satisfaction ( p  = .001), HADS-Anxiety ( p  = .009), and HADS-Depression ( p  = .001).","['Occupational Therapy Department of Hacettepe University in Turkey between January 2018 and May 2018', 'women with fibromyalgia syndrome']",['client-centered lifestyle intervention'],"['Revised Fibromyalgia Impact Questionnaire (FIQR), The Canadian Occupational Performance Measure (COPM), Hospital Anxiety and Depression Scale (HADS), and Satisfaction with Life Scale (SWLS', 'COPM-Satisfaction', 'HADS-Anxiety', 'COPM-Performance', 'HADS-Depression', 'FIQR and SWLS levels', 'levels of disease severity, occupational participation, anxiety, depression, and life satisfaction']","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.0168043,"Significant differences were found in intervention group compared to control in terms of COPM-Performance ( p  = .001), COPM-Satisfaction ( p  = .001), HADS-Anxiety ( p  = .009), and HADS-Depression ( p  = .001).","[{'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Salar', 'Affiliation': 'Faculty of Health Sciences, Department of Occupational Therapy, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'İlhan', 'Affiliation': 'Giresun University, Prof. Dr. Ilhan Ozdemir Training and Research Hospital, Giresun, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Bülbül', 'Affiliation': 'Turk Telekom Health Services Directorate, Ankara, Turkey.'}, {'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Ekici', 'Affiliation': 'Faculty of Health Sciences, Department of Occupational Therapy, Hacettepe University, Ankara, Turkey.'}]",Health care for women international,['10.1080/07399332.2020.1806282']
2891,32940569,Two-Level Factorial Pre-TomoBreast Pilot Study of Tomotherapy and Conventional Radiotherapy in Breast Cancer: Post Hoc Utility of a Mean Absolute Dose Deviation Penalty Score.,"BACKGROUND


A 2-level factorial pilot study was conducted in 2007 just before starting a randomized clinical trial comparing tomotherapy and conventional radiotherapy (CR) to reduce cardiac and pulmonary adverse effects in breast cancer, considering tumor laterality (left/right), target volume (with/without nodal irradiation), surgery (tumorectomy/mastectomy), and patient position (prone/supine). The study was revisited using a penalty score based on the recently developed mean absolute dose deviation (MADD).
METHODS


Eight patients with a unique combination of laterality, nodal coverage, and surgery underwent dual tomotherapy and CR treatment planning in both prone and supine positions, providing 32 distinct combinations. The penalty score was applied using the weighted sum of the MADDs. The Lenth method for unreplicated 2-level factorial design was used in the analysis.
RESULTS


The Lenth analysis identified nodal irradiation as the active main effect penalizing the dosimetry by 1.14 Gy (P = 0.001). Other significant effects were left laterality (0.94 Gy), mastectomy (0.61 Gy), and interactions between left mastectomy (0.89 Gy) and prone mastectomy (0.71 Gy), with P-values between 0.005 and 0.05. Tomotherapy provided a small reduction in penalty (reduction of 0.54 Gy) through interaction with nodal irradiation (P = 0.080). Some effects approached significance with P-values > 0.05 and ≤ 0.10 for interactions of prone × mastectomy × left (0.60 Gy), nodal irradiation × mastectomy (0.59 Gy), and prone × left (0.55 Gy) and the main effect prone (0.52 Gy).
CONCLUSIONS


The historical dosimetric analysis previously revealed the feasibility of tomotherapy, but a conclusion could not be made. The MADD-based score is promising, and a new analysis highlights the impact of factors and hierarchy of priorities that need to be addressed if major gains are to be attained.",2020,Tomotherapy provided a small reduction in penalty (reduction of 0.54 Gy) through interaction with nodal irradiation (P = 0.080).,"['Breast Cancer', 'Eight patients with a unique combination of laterality, nodal coverage, and surgery underwent dual tomotherapy and CR treatment planning in both prone and supine positions, providing 32 distinct combinations']","['tomotherapy and conventional radiotherapy (CR', 'Tomotherapy and Conventional Radiotherapy']",[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1831735', 'cui_str': 'Helical Tomotherapies'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C1831735', 'cui_str': 'Helical Tomotherapies'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],8.0,0.077974,Tomotherapy provided a small reduction in penalty (reduction of 0.54 Gy) through interaction with nodal irradiation (P = 0.080).,"[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Strasbourg Oncologie Liberale, Strasbourg, France.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Dipasquale', 'Affiliation': 'Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Nam P', 'Initials': 'NP', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Howard University, Washington, DC, USA.'}, {'ForeName': 'Meymey', 'Initials': 'M', 'LastName': 'San', 'Affiliation': 'Khmer Soviet Friendship Hospital, Cambodia.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Gorobets', 'Affiliation': 'University Hospital of Martinique, Site Clarac, Martinique, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Leduc', 'Affiliation': 'University Hospital of Martinique, Site Clarac, Martinique, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Verellen', 'Affiliation': 'Medical Physics, Faculty of Medicine and Health Sciences, Iridium Kankernetwerk and University of Antwerp, Wilrijk, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Storme', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Van Parijs', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'De Ridder', 'Affiliation': 'Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vinh-Hung', 'Affiliation': 'University Hospital of Martinique, Site Clarac, Martinique, France.'}]",Technology in cancer research & treatment,['10.1177/1533033820947759']
2892,30972934,Role of apolipoprotein C-III overproduction in diabetic dyslipidaemia.,"AIMS


To investigate how apolipoprotein C-III (apoC-III) metabolism is altered in subjects with type 2 diabetes, whether the perturbed plasma triglyceride concentrations in this condition are determined primarily by the secretion rate or the removal rate of apoC-III, and whether improvement of glycaemic control using the glucagon-like peptide-1 analogue liraglutide for 16 weeks modifies apoC-III dynamics.
MATERIALS AND METHODS


Postprandial apoC-III kinetics were assessed after a bolus injection of [5,5,5- 2  H 3  ]leucine using ultrasensitive mass spectrometry techniques. We compared apoC-III kinetics in two situations: in subjects with type 2 diabetes before and after liraglutide therapy, and in type 2 diabetic subjects with matched body mass index (BMI) non-diabetic subjects. Liver fat content, subcutaneous abdominal and intra-abdominal fat were determined using proton magnetic resonance spectroscopy.
RESULTS


Improved glycaemic control by liraglutide therapy for 16 weeks significantly reduced apoC-III secretion rate (561 ± 198 vs. 652 ± 196 mg/d, P = 0.03) and apoC-III levels (10.0 ± 3.8 vs. 11.7 ± 4.3 mg/dL, P = 0.035) in subjects with type 2 diabetes. Change in apoC-III secretion rate was significantly associated with the improvement in indices of glucose control (r = 0.67; P = 0.009) and change in triglyceride area under the curve (r = 0.59; P = 0.025). In line with this, the apoC-III secretion rate was higher in subjects with type 2 diabetes compared with BMI-matched non-diabetic subjects (676 ± 208 vs. 505 ± 174 mg/d, P = 0.042).
CONCLUSIONS


The results reveal that the secretion rate of apoC-III is associated with elevation of triglyceride-rich lipoproteins in subjects with type 2 diabetes, potentially through the influence of glucose homeostasis on the production of apoC-III.",2019,"RESULTS


Improved glycaemic control by liraglutide therapy for 16 weeks significantly reduced apoC-III secretion rate (561 ± 198 vs. 652 ± 196 mg/d, P = 0.03) and apoC-III levels (10.0 ± 3.8 vs. 11.7 ± 4.3 mg/dL, P = 0.035) in subjects with type 2 diabetes.","['subjects with type 2 diabetes before and after liraglutide therapy, and in type 2 diabetic subjects with matched body mass index (BMI) non-diabetic subjects', 'subjects with type 2 diabetes', 'diabetic dyslipidaemia']","['apolipoprotein C-III (apoC-III) metabolism', 'apolipoprotein C-III overproduction']","['apoC-III secretion rate', 'Liver fat content, subcutaneous abdominal and intra-abdominal fat', 'change in triglyceride area', 'indices of glucose control', 'Change in apoC-III secretion rate']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3160761', 'cui_str': 'Diabetic dyslipidaemia'}]","[{'cui': 'C0052191', 'cui_str': 'Apolipoprotein C-III'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]","[{'cui': 'C0052191', 'cui_str': 'Apolipoprotein C-III'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1563739', 'cui_str': 'Fat, Intra-Abdominal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.018318,"RESULTS


Improved glycaemic control by liraglutide therapy for 16 weeks significantly reduced apoC-III secretion rate (561 ± 198 vs. 652 ± 196 mg/d, P = 0.03) and apoC-III levels (10.0 ± 3.8 vs. 11.7 ± 4.3 mg/dL, P = 0.035) in subjects with type 2 diabetes.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Adiels', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Marja-Riitta', 'Initials': 'MR', 'LastName': 'Taskinen', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Björnson', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Andersson', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Niina', 'Initials': 'N', 'LastName': 'Matikainen', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Sanni', 'Initials': 'S', 'LastName': 'Söderlund', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Kahri', 'Affiliation': 'Department of Internal Medicine and Rehabilitation, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Hakkarainen', 'Affiliation': 'HUS Medical Imaging Center, Radiology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lundbom', 'Affiliation': 'HUS Medical Imaging Center, Radiology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Sihlbom', 'Affiliation': 'Proteomics Core Facility, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Thorsell', 'Affiliation': 'Proteomics Core Facility, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Merck Research Laboratories, Merck & Co. Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Kirsi H', 'Initials': 'KH', 'LastName': 'Pietiläinen', 'Affiliation': 'Endocrinology, Abdominal Center, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Packard', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Borén', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13744']
2893,31003921,Serum uromodulin inversely associates with aortic stiffness in youth with type 1 diabetes: A brief report from EMERALD study.,"Youth with type 1 diabetes (T1D) carry greater cardiovascular disease (CVD) risk than their nondiabetic peers. Low serum uromodulin (SUMOD) associates with increased CVD mortality in adults. We found that T1D youth have low SUMOD. Lower SUMOD correlated with aortic stiffness, suggesting its potential as a CVD biomarker in T1D.",2019,Youth with type 1 diabetes (T1D) carry greater cardiovascular disease (CVD) risk than their nondiabetic peers.,"['adults', 'youth with type 1 diabetes', 'Youth with type 1 diabetes (T1D) carry greater cardiovascular disease (CVD) risk than their nondiabetic peers']",[],"['Low serum uromodulin (SUMOD', 'CVD mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0154849,Youth with type 1 diabetes (T1D) carry greater cardiovascular disease (CVD) risk than their nondiabetic peers.,"[{'ForeName': 'Pattara', 'Initials': 'P', 'LastName': 'Wiromrat', 'Affiliation': 'Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': 'Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States; Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, United States.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Roncal', 'Affiliation': 'Department of Nephrology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': ""Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States; Center for Women's Health Research, Divisions of General Internal Medicine and Cardiology, University of Colorado School of Medicine, Aurora, CO, United States.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Baumgartner', 'Affiliation': 'Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Coe', 'Affiliation': 'Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Yesenia Garcia', 'Initials': 'YG', 'LastName': 'Reyes', 'Affiliation': 'Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Schäfer', 'Affiliation': 'Division of Pediatric Cardiology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Uyen', 'Initials': 'U', 'LastName': 'Truong', 'Affiliation': 'Division of Pediatric Cardiology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': 'Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Nephrology, University of Colorado School of Medicine, Aurora, CO, United States.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': 'Department of Pediatric Endocrinology, University of Colorado School of Medicine, Aurora, CO, United States; Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO, United States. Electronic address: kristen.nadeau@childrenscolorado.org.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.03.001']
2894,31378155,"Maternal Knowledge, Attitudes, and Behavioral Intention after Exposure to Injury Prevention Recommendations in the News Media.","INTRODUCTION


Injury prevention recommendations are frequently presented in the media. Parental understanding and response to these recommendations remain uninvestigated.
METHODS


A nationally representative sample of 1,081 mothers completed a cross-sectional survey measuring knowledge, attitudes, and behavioral intention after watching/reading video news stories and print articles on two child safety topics.
RESULTS


Of the 1,081 respondents, 33% reported hearing little about injury prevention in the media in the past 30 days, and 32% reported never hearing about injury prevention. Nearly one-half (46%) reported the injury prevention studies they had previously read or heard about in the media were confusing to them at least some of the time. The proportion of mothers who recalled the correct key statistic presented in the story varied by safety topic and medium in which the story was presented. A greater proportion of mothers correctly recalled information from the story narrative than the statistics. Mothers also rated the most interesting part of the story differently based on safety topic and medium. A small proportion were not planning to follow the safety recommendations after viewing the news story.
CONCLUSIONS


There are gaps in making injury news stories understandable and memorable for mothers in order to encourage behavioral change.",2019,Nearly one-half (46%) reported the injury prevention studies they had previously read or heard about in the media were confusing to them at least some of the time.,"['A nationally representative sample of 1,081 mothers completed a cross-sectional survey measuring knowledge, attitudes, and behavioral intention after watching/reading video news stories and print articles on two child safety topics']",[],"['hearing little about injury prevention', 'Maternal Knowledge, Attitudes, and Behavioral Intention']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}]",[],"[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",1081.0,0.0324496,Nearly one-half (46%) reported the injury prevention studies they had previously read or heard about in the media were confusing to them at least some of the time.,"[{'ForeName': 'Lara B', 'Initials': 'LB', 'LastName': 'McKenzie', 'Affiliation': ""Center for Injury Research and Policy, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Roberts', 'Affiliation': ""Center for Injury Research and Policy, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Christy L', 'Initials': 'CL', 'LastName': 'Collins', 'Affiliation': 'Datalys Center for Sports Injury Research and Prevention, Indianapolis, Indiana, USA.'}, {'ForeName': 'Roxanne M', 'Initials': 'RM', 'LastName': 'Clark', 'Affiliation': ""Center for Injury Research and Policy, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Katherine Clegg', 'Initials': 'KC', 'LastName': 'Smith', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Manganello', 'Affiliation': 'Department of Health Policy, Management, and Behavior, School of Public Health, University at Albany, Albany, NY, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1646357']
2895,31461390,Effects of Media Frame and Onset Controllability on Support for Postpartum Depression Policy.,"This study examined the processes through which media frames and onset controllability, independently or jointly, influence support for policies to help postpartum depression patients. A 2 (Frame: episodic vs. thematic) x 2 (Onset controllability: controllable vs. uncontrollable) experiment ( N  = 306) found that a thematic frame (vs. episodic) exerted a stronger impact on policy support, and such effect was serially mediated by attributions of individual/societal responsibility and empathy toward women suffering from postpartum depression. However, the relative efficacy of a thematic frame (vs. episodic) at increasing policy support depended on perceived controllability of the cause for postpartum depression; a thematic frame induced significantly greater policy support than an episodic frame when the cause was perceived to be controllable, but not when the cause was perceived to be uncontrollable. This study contributes to the literature on media framing by collectively addressing cognitive and affective processes in forming policy attitudes and identifying onset controllability as a potential boundary condition for the framing effects.",2019,"However, the relative efficacy of a thematic frame (vs. episodic) at increasing policy support depended on perceived controllability of the cause for postpartum depression; a thematic frame induced significantly greater policy support than an episodic frame when the cause was perceived to be controllable, but not when the cause was perceived to be uncontrollable.",['postpartum depression patients'],['Media Frame and Onset Controllability'],[],"[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",[],,0.0380106,"However, the relative efficacy of a thematic frame (vs. episodic) at increasing policy support depended on perceived controllability of the cause for postpartum depression; a thematic frame induced significantly greater policy support than an episodic frame when the cause was perceived to be controllable, but not when the cause was perceived to be uncontrollable.","[{'ForeName': 'Myojung', 'Initials': 'M', 'LastName': 'Chung', 'Affiliation': 'School of Journalism, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Hye Kyung', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Wee Kim Wee School of Communication and Information, Nanyang Technological University, Singapore.'}]",Journal of health communication,['10.1080/10810730.2019.1657525']
2896,31871348,Comparison of Rewatching Class Recordings versus Retrieval Practice as Post-Lecture Learning Strategies.,"Objective.  To assess the relative effectiveness of two study strategies, rewatching a recorded lecture and retrieval practice, on Doctor of Pharmacy (PharmD) students' long-term retention of lecture material presented in a pharmacotherapeutics class.  Methods.  One hundred two first-year pharmacy students were recruited for the study. All students attended two in-class lectures on different topics. The following week, students either re-studied from the recorded lecture on one of the two topics or, on the other topic, retrieved information about class content by responding to the course objectives. Half of the students were quizzed immediately after studying both topics. One week later, all students were required to complete an unannounced quiz to measure long-term retention. Finally, students were surveyed regarding their perceptions of the two learning strategies. Time on task was recorded to assess the efficiency of each learning strategy.  Results.  The primary outcome was student performance on the unannounced quiz administered one week after restudy of the lecture. No difference in performance was found between students who restudied the recorded lecture versus students who retrieved information about the lecture. However, immediately after restudying the material, students who studied from the recorded lecture performed better than students who retrieved information on the lecture. In terms of efficiency, the retrieval learning method required less time for the same gain in students' long-term retention of knowledge.  Conclusions.  Testing may be more efficient (ie, cost-effective) for long-term performance. Students who attend class may want to avoid rewatching course recordings in favor of practice testing.",2019,No difference in performance was found between students who restudied the recorded lecture versus students who retrieved information about the lecture.,"['One hundred two first-year pharmacy students were recruited for the study', 'Students who attend class may want to avoid rewatching course recordings in favor of practice testing']",[],['student performance on the unannounced quiz administered one week after restudy of the lecture'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}]",,0.0173213,No difference in performance was found between students who restudied the recorded lecture versus students who retrieved information about the lecture.,"[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Palmer', 'Affiliation': 'University of North Carolina at Chapel Hill, Eshelman School of Pharmacy, Chapel Hill, North Carolina.'}, {'ForeName': 'Youn', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'University of North Carolina at Chapel Hill, Eshelman School of Pharmacy, Chapel Hill, North Carolina.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Persky', 'Affiliation': 'University of North Carolina at Chapel Hill, Eshelman School of Pharmacy, Chapel Hill, North Carolina.'}]",American journal of pharmaceutical education,['10.5688/ajpe7217']
2897,32683828,[Total mesorectal excision with preservation of Denonvilliers' fascia (iTME) based on membrane anatomy].,"Total mesorectal excision (TME) has been advocated as the golden standard of mid-low rectal cancer surgery for nearly 30 years. However, the complication of postoperative urinary and sexual dysfunctions due to intraoperative nerve injury has yet to be improved. Based on the concept of membrane anatomy, we carried out a systematic study on the important membrane anatomical structure anterior to the rectum--Denonvilliers' fascia. From multiple aspects including anatomy, physiology, histochemistry and surgical practice, we verified the importance of Denonvilliers' fascia for TME surgery in prevention of intraoperative nerve injury and postoperative urogenital dysfunction. Moreover, based on anatomical study of the surgical marker line of Denonvilliers' fascia (Wei's line) and surgical plane, we proved that total mesorectal excision with preservation of Denonvilliers' fascia (iTME) was feasible and practical. Therefore, we conducted a large multicentric randomized controlled trial (RCT). The mid-term result demonstrated that compared with traditional TME surgery, iTME was more effective in reducing the incidence of postoperative urinary and sexual dysfunctions in male patients with mid-low rectal cancer, without sacrifice of short-term tumor radical outcome. We believe that the final RCT result of iTME, based on membrane anatomy, will provide solid evidence for the update of concepts of rectal cancer surgery.",2020,"The mid-term result demonstrated that compared with traditional TME surgery, iTME was more effective in reducing the incidence of postoperative urinary and sexual dysfunctions in male patients with mid-low rectal cancer, without sacrifice of short-term tumor radical outcome.",['male patients with mid-low rectal cancer'],"['Total mesorectal excision (TME', 'TME surgery', ""Total mesorectal excision with preservation of Denonvilliers' fascia (iTME"", ""total mesorectal excision with preservation of Denonvilliers' fascia (iTME"", 'traditional TME surgery, iTME']",['postoperative urinary and sexual dysfunctions'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]",,0.0238706,"The mid-term result demonstrated that compared with traditional TME surgery, iTME was more effective in reducing the incidence of postoperative urinary and sexual dysfunctions in male patients with mid-low rectal cancer, without sacrifice of short-term tumor radical outcome.","[{'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Wei', 'Affiliation': 'Department of Gastrointestinal Surgery, the Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510630, China.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Fang', 'Affiliation': 'Department of Gastrointestinal Surgery, the Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510630, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.cn.441530-20200430-00251']
2898,30738562,"Process Evaluation of Strong Hearts, Healthy Communities: A Rural Community-Based Cardiovascular Disease Prevention Program.","OBJECTIVE


To evaluate the implementation of a community-based cardiovascular disease prevention program for rural women: Strong Hearts, Healthy Communities (SHHC).
DESIGN


Mixed-methods process evaluation.
SETTING/PARTICIPANTS


A total of 101 women from 8 rural towns were enrolled in the SHHC program; 93 were enrolled as controls. Eligible participants were aged ≥40 years, sedentary, and overweight or obese. Local health educators (n = 15) served as program leaders within each town.
OUTCOME MEASURES


Reach, fidelity, dose delivered, dose received, and program satisfaction were assessed using after-class surveys, participant satisfaction surveys, interviews with program leaders, and participant focus groups.
ANALYSIS


Descriptive statistics, chi-square tests of independence, and thematic analysis were employed.
RESULTS


Intervention sites reported high levels of fidelity (82%) and dose delivered (84%). Overall reach was 2.6% and program classes were rated as effective (3.9/5). Participants were satisfied with their experience and reported benefits such as camaraderie and awareness of healthy eating and exercise strategies. Common recommendations included increasing class time and enhancing group discussion.
CONCLUSIONS AND IMPLICATIONS


Implementation was good in terms of fidelity, dose delivered, and satisfaction, although low reach. Findings from this research have informed a second round of implementation and evaluation of the SHHC program in rural communities.",2019,Participants were satisfied with their experience and reported benefits such as camaraderie and awareness of healthy eating and exercise strategies.,"['rural women: Strong Hearts, Healthy Communities (SHHC', 'Strong Hearts, Healthy Communities', 'Local health educators (n\u202f=\u202f15) served as program leaders within each town', 'A total of 101 women from 8 rural towns were enrolled in the SHHC program; 93 were enrolled as controls', 'Eligible participants were aged ≥40 years, sedentary, and overweight or obese']",['community-based cardiovascular disease prevention program'],"['Reach, fidelity, dose delivered, dose received, and program satisfaction', 'high levels of fidelity', 'Overall reach']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",101.0,0.0263376,Participants were satisfied with their experience and reported benefits such as camaraderie and awareness of healthy eating and exercise strategies.,"[{'ForeName': 'Urshila', 'Initials': 'U', 'LastName': 'Sriram', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Sandreuter', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Folta', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pullyblank', 'Affiliation': 'Bassett Research Institute, Cooperstown, NY.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'College of Education, Health and Development, Montana State University, Bozeman, MT.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Seguin', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY. Electronic address: rs946@cornell.edu.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.10.011']
2899,31397719,Emotional and behavioral resilience among children with perinatally acquired HIV in Thailand and Cambodia.,"OBJECTIVES


Psychosocial challenges associated with perinatally acquired HIV (PHIV) infection are well known, yet many children infected with HIV since birth demonstrate positive outcomes, referred to as resilience. The purpose of this study was to evaluate emotional-behavioral development and identify salient predictors of resilience among long-term survivors of PHIV.
DESIGN


Prospective investigation of children with PHIV compared with demographically similar perinatally HIV-exposed but uninfected (PHEU) and HIV-unexposed, uninfected (HUU) children, all from Thailand and Cambodia.
METHODS


The Child Behavior Checklist (CBCL; parent version) was administered at baseline and annual follow-up visits (median follow-up of 3 years) to children age 6-14. Resilience was defined as consistent CBCL scores on the Internalizing, Externalizing or Total Problem T scales within normative ranges (T-scores <60) at every time point. Generalized estimating equations examined CBCL scores over time and logistic models examined demographic, socioeconomic, and cultural predictors of resilience.
RESULTS


Participants included 448 children (236 PHIV, 98 PHEU, 114 HUU), with median (interquartile range) age at first evaluation of 7 (6-9) years. Children with PHIV exhibited similar rates of resilience as PHEU and HUU on the Externalizing and Total Problems scales. Resilience on the Internalizing scale was more likely in PHEU (71%) compared with PHIV (59%) or HUU (56%), P = 0.049. Factors associated with resilience in adjusted models included: HIV-exposed but uninfected status, higher household income, Cambodian nationality, female sex, and caregiver type.
CONCLUSION


Despite biopsychosocial risks, resilience is observed among PHIV and PHEU children. Further study is needed to understand mechanisms underlying associated factors and intervention priorities.",2019,Children with PHIV exhibited similar rates of resilience as PHEU and HUU on the Externalizing and Total Problems scales.,"['children with perinatally acquired HIV in Thailand and Cambodia', 'children with PHIV compared with demographically similar perinatally HIV-exposed but uninfected (PHEU) and HIV-unexposed, uninfected (HUU) children, all from Thailand and Cambodia', 'Participants included 448 children (236 PHIV, 98 PHEU, 114 HUU), with median (interquartile range) age at first evaluation of 7 (6-9) years']",[],"['CBCL scores on the Internalizing, Externalizing or Total Problem T scales', 'emotional-behavioral development', 'Emotional and behavioral resilience', 'Child Behavior Checklist (CBCL; parent version', 'Externalizing and Total Problems scales', 'Internalizing scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006797', 'cui_str': 'Cambodia'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",448.0,0.0511227,Children with PHIV exhibited similar rates of resilience as PHEU and HUU on the Externalizing and Total Problems scales.,"[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Malee', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kerr', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Missouri Institute of Mental Health, University of Missouri-St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Kulvadee', 'Initials': 'K', 'LastName': 'Thongpibul', 'Affiliation': 'Department of Psychology, Faculty of Humanities, Chiang Mai University, Chiang Mai.'}, {'ForeName': 'Pope', 'Initials': 'P', 'LastName': 'Kosalaraksa', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen.'}, {'ForeName': 'Pradthana', 'Initials': 'P', 'LastName': 'Ounchanum', 'Affiliation': 'Department of Pediatrics, Chiangrai Prachanukroh Hospital, Chiang Rai.'}, {'ForeName': 'Suparat', 'Initials': 'S', 'LastName': 'Kanjanavanit', 'Affiliation': 'Nakornping Hospital.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Aurpibul', 'Affiliation': 'Research Institute for Health Sciences, Chiang Mai.'}, {'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Ngampiyaskul', 'Affiliation': 'Prapokklao Hospital, Chanthaburi.'}, {'ForeName': 'Wicharn', 'Initials': 'W', 'LastName': 'Luesomboon', 'Affiliation': 'Queen Savang Vadhana Memorial Hospital, Chonburi.'}, {'ForeName': 'Jurai', 'Initials': 'J', 'LastName': 'Wongsawat', 'Affiliation': 'Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand.'}, {'ForeName': 'Saphonn', 'Initials': 'S', 'LastName': 'Vonthanak', 'Affiliation': 'University of Health Science.'}, {'ForeName': 'Penh S', 'Initials': 'PS', 'LastName': 'Ly', 'Affiliation': 'National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Chettra', 'Affiliation': 'National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia.'}, {'ForeName': 'Tulathip', 'Initials': 'T', 'LastName': 'Suwanlerk', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Jiratchaya', 'Initials': 'J', 'LastName': 'Sophonphan', 'Affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Center, Bangkok, Thailand.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Valcour', 'Affiliation': 'Department of Neurology, Memory and Aging Center, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jintanat', 'Initials': 'J', 'LastName': 'Ananworanich', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University, New York, New York, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002182']
2900,31652452,Association between PHOX2B gene rs28647582 T>C polymorphism and Wilms tumor susceptibility.,"Wilms tumor is one of the most common pediatric solid tumors. The pair-like homeobox 2b (PHOX2B) gene is an important transcription factor that regulates cellular proliferation and differentiation in early life. The association between PHOX2B single nucleotide polymorphisms (SNPs) and Wilms tumor risk has not been investigated. Therefore, we conducted a case-control study involving 145 Wilms tumor patients and 531 controls to explore the association between the PHOX2B rs28647582 T>C polymorphism and Wilms tumor susceptibility. The association between the PHOX2B rs28647582 T>C polymorphism and Wilms tumor susceptibility was assessed by odds ratios (ORs) and 95% confidence intervals (CIs). Our results indicated that PHOX2B rs28647582 T>C polymorphism did not significantly alter Wilms tumor susceptibility. However, in the stratified analysis, we found that TC/CC genotypes significantly increased Wilms tumor risk among children older than 18 months (adjusted OR = 1.77, 95% CI = 1.07-2.95, P=0.027) and those with clinical stages III+IV (adjusted OR = 1.75, 95% CI = 1.09-2.82, P=0.022), when compared with those with TT genotype. Our study suggested that PHOX2B rs28647582 T>C was weakly associated with Wilms tumor susceptibility. Our conclusions need further validation with a larger sample size.",2019,The association between the PHOX2B rs28647582 T>C polymorphism and Wilms tumor susceptibility was assessed by odds ratios (ORs) and 95% confidence intervals (CIs).,['145 Wilms tumor patients and 531 controls to explore the association between the PHOX2B rs28647582 T>C polymorphism and Wilms tumor susceptibility'],[],"['Wilms tumor risk', 'Wilms tumor susceptibility', 'PHOX2B rs28647582 T>C polymorphism and Wilms tumor susceptibility']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0027708', 'cui_str': 'Nephroblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242303', 'cui_str': 'Sequence, Homeo Box'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",[],"[{'cui': 'C0027708', 'cui_str': 'Nephroblastoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0242303', 'cui_str': 'Sequence, Homeo Box'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]",145.0,0.0223368,The association between the PHOX2B rs28647582 T>C polymorphism and Wilms tumor susceptibility was assessed by odds ratios (ORs) and 95% confidence intervals (CIs).,"[{'ForeName': 'Ao', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': ""Department of Pediatric Surgery, Guangzhou Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, Guangdong, China.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': ""Department of Pediatric Surgery, Guangzhou Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, Guangdong, China.""}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, The Affiliated Wuxi No.2 People's Hospital of Nanjing Medical University, Wuxi 214000, Jiangsu, China.""}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Clinical Laboratory, Biobank, Harbin Medical University Cancer Hospital, Harbin 150040, Heilongjiang, China.'}, {'ForeName': 'Jiabin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatric Surgery, Guangzhou Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, Guangdong, China.""}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': ""Department of Pediatric Surgery, Guangzhou Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, Guangdong, China.""}, {'ForeName': 'Guochang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Pediatric Surgery, Guangzhou Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, Guangdong, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Pediatric Surgery, Guangzhou Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, Guangdong, China.""}]",Bioscience reports,['10.1042/BSR20192529']
2901,32936595,Not Just for Joints: The Associations of Moderate-to-Vigorous Physical Activity and Sedentary Behavior with Brain Cortical Thickness.,"INTRODUCTION


Cortical thinning is associated with aging; however, lifestyle factors can moderate this relationship. Two distinct lifestyle behaviors associated with brain health are regular moderate-to-vigorous physical activity (MVPA) and limited sedentary behavior (SB). However, it is unclear whether MVPA and SB levels contribute to cortical thickness independent of each other. We therefore investigated the independent relationships of MVPA and SB with cortical thickness using baseline data from a randomized controlled trial.
METHODS


At baseline, we measured MVPA and SB for 7 d using the SenseWear Mini. A subset of the randomized controlled trial participants (n = 30) underwent a 3T magnetic resonance imaging scan, wherein region-specific cortical surface morphometric analyses were performed using T1-weighted structural magnetic resonance imaging. We conducted regression analyses using a surface-based cluster size exclusion method for multiple comparisons within FreeSurfer neuroimaging software to determine if MVPA and SB are independently correlated with region-specific cortical thickness.
RESULTS


This subset of participants had a mean age of 61 yr (SD = 9 yr), and 80% were female. Higher MVPA was associated with greater cortical thickness in the temporal pole (cluster size, 855 mm; cortical thickness range, 2.59-3.72 mm; P < 0.05) and superior frontal gyrus (cluster size, 1204 mm; cortical thickness range, 2.41-3.15 mm; P < 0.05) of the left hemisphere, independent of SB. Sedentary behavior was not associated with greater cortical thickness in any region, independent of MVPA.
CONCLUSIONS


Our results indicate that adults with greater MVPA-independent of SB-are associated with greater cortical thickness in regions, which are susceptible to age-associated atrophy.",2020,"Higher MVPA was associated with greater cortical thickness in the temporal pole (cluster size, 855 mm; cortical thickness range, 2.59-3.72 mm; P < 0.05) and superior frontal gyrus (cluster size, 1204 mm; cortical thickness range, 2.41-3.15 mm; P < 0.05) of the left hemisphere, independent of SB.","['Joints', 'participants had a mean age of 61 yr (SD = 9 yr), and 80% were female']",['3T magnetic resonance imaging scan'],"['cortical thickness', 'MVPA and SB']","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.158306,"Higher MVPA was associated with greater cortical thickness in the temporal pole (cluster size, 855 mm; cortical thickness range, 2.59-3.72 mm; P < 0.05) and superior frontal gyrus (cluster size, 1204 mm; cortical thickness range, 2.41-3.15 mm; P < 0.05) of the left hemisphere, independent of SB.","[{'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Falck', 'Affiliation': '1University of British Columbia, Faculty of Medicine, Aging, Mobility and Cognitive Neuroscience Laboratory, Djavad Mowafaghian Centre for Brain Health, Vancouver Coastal Health Research Institute, Vancouver, BC, CANADA 2University of British Columbia, Faculty of Medicine, Arthritis Research Canada, Vancouver, BC, CANADA.'}, {'ForeName': 'Chun L', 'Initials': 'CL', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Best', 'Affiliation': ''}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Egbert', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002374']
2902,32936675,Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) Trial Protocol.,"Expert recommendations to discuss prognosis and offer palliative options for critically ill patients at high risk of death are variably heeded by intensive care unit (ICU) clinicians. How to best promote such communication to avoid potentially unwanted aggressive care is unknown. The Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) study is a 33-month pragmatic, stepped-wedge, cluster randomized trial testing the effectiveness of two electronic health record (EHR) interventions designed to increase ICU clinicians' engagement of critically ill patients at high risk of death and their caregivers in discussions about all treatment options, including care focused on comfort. We hypothesize that the quality of care and patient-centered outcomes can be improved by requiring ICU clinicians to document a functional prognostic estimate (Intervention A) and/or to provide justification if they have not offered patients the option of comfort-focused care (Intervention B). The trial enrolls all adult patients admitted to 17 ICUs in 10 hospitals in North Carolina with a pre-existing life-limiting illness and acute respiratory failure requiring continuous mechanical ventilation for at least 48 hours. Eligibility is determined using a validated algorithm in the EHR. The sequence in which hospitals transition from usual care (control), to intervention A or B, and then to combined interventions A + B, is randomly assigned. The primary outcome is hospital length of stay. Secondary outcomes include other clinical outcomes, palliative care process measures, and nurse-assessed quality of dying and death. Trial registration: ClinicalTrials.gov Identifier NCT03139838.",2020,"The Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) study is a 33-month pragmatic, stepped-wedge, cluster randomized trial testing the effectiveness of two electronic health record (EHR) interventions designed to increase ICU clinicians' engagement of critically ill patients at high risk of death and their caregivers in discussions about all treatment options, including care focused on comfort.","['adult patients admitted to 17 ICUs in 10 hospitals in North Carolina with a pre-existing life-limiting illness and acute respiratory failure requiring continuous mechanical ventilation for at least 48 hours', 'critically ill patients at high risk of death and their caregivers in discussions', 'critically ill patients at high risk of death are variably heeded by intensive care unit (ICU) clinicians']",['electronic health record (EHR) interventions'],"['clinical outcomes, palliative care process measures, and nurse-assessed quality of dying and death', 'hospital length of stay']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0086850', 'cui_str': 'Process Measures'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.145145,"The Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) study is a 33-month pragmatic, stepped-wedge, cluster randomized trial testing the effectiveness of two electronic health record (EHR) interventions designed to increase ICU clinicians' engagement of critically ill patients at high risk of death and their caregivers in discussions about all treatment options, including care focused on comfort.","[{'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Courtright', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Medicine, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Dress', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Palliative and Advanced Illness Research (PAIR) Center, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Jaspal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Atrium Health, 2351, Critical Care Network, Adult Acute Division and Department of Medicine, Charlotte, North Carolina, United States.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bayes', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Palliative and Advanced Illness Research (PAIR) Center, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Marzana', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Palliative and Advanced Illness Research (PAIR) Center, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'University of Pennsylvania Wharton School, 25825, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hetherington', 'Affiliation': 'Atrium Health, 2351, Center for Outcomes Research & Evaluation (CORE), Charlotte, North Carolina, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Plickert', 'Affiliation': 'Atrium Health, 2351, Information and Analytics Services, Charlotte, North Carolina, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Detsky', 'Affiliation': 'Sinai Health System, 518775, Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Doctor', 'Affiliation': 'University of Southern California, 5116, Department of Health Policy and Management, Sol Price School of Public Policy, Los Angeles, California, United States.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Harhay', 'Affiliation': 'University of Pennsylvania, 6572, Biostatistics, Epidemiology and Informatics, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Burke', 'Affiliation': 'Atrium Health, 2351, Division of Palliative Care, Adult Acute Care Services and Department of Medicine, Charlotte, North Carolina, United States.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Green', 'Affiliation': 'Atrium Health, 2351, Critical Care Network, Adult Acute Division and Department of Medicine, Charlotte, North Carolina, United States.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Huynh', 'Affiliation': 'Atrium Health, 2351, Division of Trauma, Surgical Critical Care, and Acute Care Surgery, Department of General Surgery, Charlotte, North Carolina, United States.'}, {'ForeName': 'D Matthew', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'Atrium Health, 2351, Information and Analytics Services, Charlotte, North Carolina, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Medicine, Philadelphia, Pennsylvania, United States.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202002-088SD']
2903,32936680,Effects of sex and menstrual cycle on volume regulatory responses to 24-h fluid restriction.,"Reproductive hormones can have significant non-reproductive physiological effects, including altering the regulation of body fluid volume. The purpose of this investigation was to explore the impact of sex and menstrual cycle (MC) phase on volume regulatory responses to 24-hour fluid restriction (24-h FR). Participants (men: n=12, 20±2y; women: n=10, 20±1y) were assigned two randomized and counterbalanced fluid prescriptions (Euhy: euhydrated, urine specific gravity, USG<1.020; Dehy: 24-h FR, USG>1.020). Men completed both (MEuhy, MDehy) while women completed both in the late follicular (days 10-13; FDehy, FEuhy) and mid-luteal (days 18-22; LDehy, LEuhy) phases. We measured body mass, plasma and urine osmolality (P osm , U osm ), USG, urine color (U col ) and serum copeptin. 24-h FR yielded mild dehydration with no influence of sex or MC phase (P>0.05). Men exhibited higher copeptin following Dehy (pre: 8.2±5.2, post: 15.8±12.6, P=0.04) but women did not (FDehy - pre: 4.3±1.6, post: 10.5±6.9, P=0.06; LDehy - pre: 5.6±3.5, post: 10.4±6.2, P=0.16). In FDehy women, P osm  increased following FR (pre: 288±2, post: 292±1, P=0.03) but not in men (pre: 292±3, post: 293±2, P=0.46). No MC differences were observed between %BML, P osm , U osm , USG, U col , and serum copeptin (P>0.05). These results suggest that copeptin responses to mild dehydration elicited via 24-h FR were present in men only, regardless of MC phase in young healthy adults.",2020,"Men exhibited higher copeptin following Dehy (pre: 8.2±5.2, post: 15.8±12.6, P=0.04) but women did not (FDehy - pre: 4.3±1.6, post: 10.5±6.9, P=0.06; LDehy - pre: 5.6±3.5, post: 10.4±6.2, P=0.16).","['young healthy adults', 'Participants (men: n=12, 20±2y; women: n=10, 20±1y']",['24-hour fluid restriction (24-h FR'],"['body mass, plasma and urine osmolality (P osm , U osm ), USG, urine color (U col ) and serum copeptin', 'BML, P osm , U osm , USG, U col , and serum copeptin']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0439186', 'cui_str': 'osmol'}, {'cui': 'C0278030', 'cui_str': 'Color of urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",,0.0971306,"Men exhibited higher copeptin following Dehy (pre: 8.2±5.2, post: 15.8±12.6, P=0.04) but women did not (FDehy - pre: 4.3±1.6, post: 10.5±6.9, P=0.06; LDehy - pre: 5.6±3.5, post: 10.4±6.2, P=0.16).","[{'ForeName': 'Gabrielle E W', 'Initials': 'GEW', 'LastName': 'Giersch', 'Affiliation': 'United States Army Research Institute for Environmental Medicine, Natick, MA USA; Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': 'Arizona State University, Hydration Science Laboratory, Phoenix, AZ, United States.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Morrissey', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Cody R', 'Initials': 'CR', 'LastName': 'Butler', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'Pruchnicki', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': 'Arizona State University, Hydration Science Laboratory, Phoenix, AZ, United States.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'U.S. Army Research Institute of Environmental Medicine, United States.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, CT, United States.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00173.2020']
2904,32936713,Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-Positive Early Breast Cancer in Older Patients.,"PURPOSE


Adjuvant trastuzumab monotherapy has not been compared with trastuzumab + chemotherapy. We investigated the relative value of trastuzumab monotherapy for older patients with breast cancer.
METHODS


This study was an open-label, randomized controlled study with a treatment selection design in which a noninferiority criterion was predefined. Patients aged 70-80 years with surgically treated human epidermal growth factor receptor 2-positive invasive breast cancer received trastuzumab monotherapy or trastuzumab + chemotherapy. The primary end point was disease-free survival (DFS) with assessment of prespecified hazard ratio (HR), relapse-free survival (RFS), adverse events (AEs), health-related quality of life (HRQoL), and restricted mean survival time (RMST).
RESULTS


The study involved 275 patients (mean age, 73.5 years) who were followed up for a mean of 4.1 years (range, 0.3-8.0 years). The percentages of patients by cancer stage were as follows: I (pT > 0.5 cm), 43.6%; IIA, 41.7%; IIB, 13.5%; and IIIA, 1.1%. Three-year DFS was 89.5% with trastuzumab monotherapy versus 93.8% with trastuzumab + chemotherapy (HR, 1.36; 95% CI, 0.72 to 2.58;  P  = .51). At 3 years, RMST differed by -0.39 months between arms (95% CI, -1.71 to 0.93;  P  = .56). Three-year RFS was 92.4% with trastuzumab monotherapy versus 95.3% with trastuzumab + chemotherapy (HR, 1.33; 95% CI, 0.63 to 2.79;  P  = .53). Common AEs were anorexia (7.4%  v  44.3%;  P  < .0001) and alopecia (2.2%  v  71.7%;  P  < .0001), and grade 3/4 nonhematologic AEs occurred in 11.9% versus 29.8% ( P  = .0003) for trastuzumab monotherapy versus trastuzumab + chemotherapy, respectively. Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy  v  48% for trastuzumab + chemotherapy;  P  = .016) and at 1 year (19%  v  38%;  P  = .009).
CONCLUSION


The primary objective of noninferiority for trastuzumab monotherapy was not met. However, the observed loss of survival without chemotherapy was < 1 month at 3 years. Therefore, and in light of the lower toxicity and more favorable HRQoL profile, trastuzumab monotherapy can be considered an adjuvant therapy option for selected older patients.",2020,"Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy  v  48% for trastuzumab + chemotherapy;  P  = .016) and at 1 year (19%  v  38%;  P  = .009).
","['Patients aged 70-80 years with surgically treated human epidermal growth factor receptor 2-positive invasive breast cancer received', '275 patients (mean age, 73.5 years) who were followed up for a mean of 4.1 years (range, 0.3-8.0 years', 'selected older patients', 'older patients with breast cancer', 'HER2-Positive Early Breast Cancer in Older Patients']","['trastuzumab monotherapy or trastuzumab + chemotherapy', 'trastuzumab + chemotherapy', 'Trastuzumab With or Without Chemotherapy', 'trastuzumab monotherapy']","['anorexia', 'grade 3/4 nonhematologic AEs', 'Clinically meaningful HRQoL deterioration rate', 'alopecia', 'disease-free survival (DFS) with assessment of prespecified hazard ratio (HR), relapse-free survival (RFS), adverse events (AEs), health-related quality of life (HRQoL), and restricted mean survival time (RMST']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}]",275.0,0.182377,"Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy  v  48% for trastuzumab + chemotherapy;  P  = .016) and at 1 year (19%  v  38%;  P  = .009).
","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Sawaki', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Naruto', 'Initials': 'N', 'LastName': 'Taira', 'Affiliation': 'Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Baba', 'Affiliation': 'Department of Surgery, Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Kokoro', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medical Oncology, the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Surgery, Aomori City Hospital, Aomori, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Tsuneizumi', 'Affiliation': 'Department of Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sagawa', 'Affiliation': 'Department of Breast Surgery, Kameda Medical Center, Kamogawa, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kashiwaba', 'Affiliation': 'Department of Surgery, Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Department of Medical Oncology, Mie University Hospital, Tsu, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00184']
2905,32936790,Efficacy and Safety of Neuromuscular Blockade in Overweight Patients Undergoing Nasopharyngeal Surgery.,"BACKGROUND Adequate muscle relaxation and rapid recovery of neuromuscular function are essential in the perioperative period. We therefore compared various anesthetic regimens of neuromuscular blockers and antagonists administered to overweight patients undergoing nasopharyngeal surgery. MATERIAL AND METHODS This prospective, randomized, double-blind study was conducted in overweight patients undergoing nasopharyngeal surgery. We randomly assigned 102 patients into 3 groups (each n=34) treated with various muscle relaxant agents and antagonists: rocuronium and sugammadex (Group RS), rocuronium and neostigmine (Group RN), and cisatracurium and neostigmine (Group CN). Then, we compared the efficacy and safety indexes of the 3 groups. RESULTS Onset times of muscular relaxation in Group RS and Group RN (110 s and 120 s) were shorter than in Group CN (183 s). Time from administration of antagonist to recovery of the TOF ratio to 0.9 was shorter in Group RS (3.3 min) than in other groups (20.7 min and 19.1 min, respectively). The incidence of postoperative residual curarization (PORC) was significantly lower in Group RS (5.9%) than in the other 2 groups (both 41.2%). The hemodynamic parameter changes before extubation were significantly higher in Group RN and Group CN than in Group RS. The postoperative pain scores were lowest in Group RS. CONCLUSIONS For overweight patients undergoing nasopharyngeal surgery, the use of rocuronium with sugammadex had the shortest onset time of neuromuscular relaxation, accelerated the reversion of neuromuscular blockade, effectively reduced the occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability before extubation. The combination of rocuronium and sugammadex may be the best anesthetic regimen for overweight patients undergoing nasopharyngeal surgery.",2020,"For overweight patients undergoing nasopharyngeal surgery, the use of rocuronium with sugammadex had the shortest onset time of neuromuscular relaxation, accelerated the reversion of neuromuscular blockade, effectively reduced the occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability before extubation.","['Overweight Patients Undergoing Nasopharyngeal Surgery', '102 patients into 3 groups (each n=34) treated with', 'overweight patients undergoing nasopharyngeal surgery']","['rocuronium with sugammadex', 'rocuronium and sugammadex', 'various muscle relaxant agents and antagonists: rocuronium and sugammadex (Group RS), rocuronium and neostigmine (Group RN), and cisatracurium and neostigmine (Group CN', 'Neuromuscular Blockade', 'neuromuscular blockers and antagonists']","['Efficacy and Safety', 'incidence of postoperative residual curarization (PORC', 'hemodynamic parameter changes before extubation', 'TOF ratio', 'efficacy and safety indexes', 'postoperative pain scores', 'occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948545', 'cui_str': 'Nasopharyngeal surgery'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0027866', 'cui_str': 'Neuromuscular blocking agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4042763', 'cui_str': 'Postoperative Residual Curarisation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",102.0,0.0821534,"For overweight patients undergoing nasopharyngeal surgery, the use of rocuronium with sugammadex had the shortest onset time of neuromuscular relaxation, accelerated the reversion of neuromuscular blockade, effectively reduced the occurrence of PORC, relieved postoperative pain, and maintained hemodynamic stability before extubation.","[{'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Niu', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Shanglong', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926452']
2906,32936897,Striatal dopamine D2 receptor occupancy induced by daily application of blonanserin transdermal patches: Phase 2 study in Japanese patients with schizophrenia.,"BACKGROUND


Transdermal antipsychotic patch formulations offer potential benefits, including improved adherence. This study investigated the striatal dopamine D2 receptor occupancy with daily blonanserin transdermal patch application.
METHODS


This open-label, Phase 2 study enrolled 18 Japanese outpatients (20 to <65 years) with schizophrenia (DSM-IV-TR criteria; total Positive and Negative Syndrome Scale [PANSS] score <120 at screening) treated with blonanserin 8 mg or 16 mg tablets. Patients continued tablets for 2-4 weeks at their current dose and were then assigned to once-daily blonanserin patches (10/20/40/60/80 mg daily) for 2-4 weeks based on the oral dose. [ 11C]raclopride PET scanning determined blonanserin striatal dopamine D2 receptor occupancy (primary endpoint). Secondary endpoints included assessment of receptor occupancy by dose, changes in PANSS and CGI-S scores, patient attitudes towards adherence, and patch adhesiveness.
RESULTS


Of 18 patients who started the blonanserin tablet treatment period, 14 patients completed treatment. Mean D2 receptor occupancy for blonanserin tablets 8 mg/day (59.2%, n=5) and 16 mg/day (66.3%, n=9) was within the values for blonanserin patches: 10 mg/day (33.3%, n=3), 20 mg/day (29.9%, n=2), 40 mg/day (61.2%, n=3), 60 mg/day (59.0%, n=3), and 80 mg/day (69.9%, n=3). Occupancy generally increased with increasing blonanserin dose for both formulations with the half maximal receptor occupancy for tablets and patches associated with doses of 6.9 mg/day and 31.9 mg/day, respectively. Diurnal variability in occupancy was lower during transdermal patch treatment than during tablet treatment. Blonanserin transdermal patches were well tolerated with no major safety concerns.
CONCLUSIONS


Blonanserin patches (40/80 mg/day) have lower diurnal variability in occupancy than blonanserin tablets (8/16 mg/day) and patches at doses of 40 mg/day and 80 mg/day appear to be suitable alternative for blonanserin tablets at doses of 8 mg and 16 mg/day, respectively. Blonanserin patches represent a potential new treatment option for patients with schizophrenia.",2020,"Occupancy generally increased with increasing blonanserin dose for both formulations with the half maximal receptor occupancy for tablets and patches associated with doses of 6.9 mg/day and 31.9 mg/day, respectively.","['18 Japanese outpatients (20 to <65 years) with schizophrenia (DSM-IV-TR criteria; total Positive and Negative Syndrome Scale [PANSS] score <120 at screening) treated with', 'Japanese patients with schizophrenia', '18 patients who started the blonanserin tablet treatment period, 14 patients completed treatment', 'patients with schizophrenia']","['Blonanserin transdermal patches', 'blonanserin transdermal patches', 'blonanserin 8\xa0mg or 16\xa0mg tablets', 'Blonanserin patches', 'blonanserin tablets', 'blonanserin', 'blonanserin patches']","['assessment of receptor occupancy by dose, changes in PANSS and CGI-S scores, patient attitudes towards adherence, and patch adhesiveness', 'Occupancy', 'Diurnal variability in occupancy', 'Mean D2 receptor occupancy']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0001515', 'cui_str': 'Adhesiveness'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0058698', 'cui_str': 'Dopamine-D2 Receptor'}]",18.0,0.0297833,"Occupancy generally increased with increasing blonanserin dose for both formulations with the half maximal receptor occupancy for tablets and patches associated with doses of 6.9 mg/day and 31.9 mg/day, respectively.","[{'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Nishibe', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Tateno', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakayori', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'WooChan', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kakuyama', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa071']
2907,32936951,"Tension-free mesh versus suture-alone cruroplasty in antireflux surgery: a randomized, double-blind clinical trial.","BACKGROUND


Antireflux surgery is effective for the treatment of gastro-oesophageal reflux disease (GORD) but recurrence of hiatal hernia remains a challenge. In other types of hernia repair, use of mesh is associated with reduced recurrence rates. The aim of this study was to compare the use of mesh versus sutures alone for the repair of hiatal hernia in laparoscopic antireflux surgery.
METHODS


Patients undergoing laparoscopic Nissen fundoplication for GORD between January 2006 and December 2010 were allocated randomly to closure of the diaphragmatic hiatus with crural sutures or non-absorbable polytetrafluoroethylene mesh (CruraSoft®). The primary outcome was recurrence of hiatal hernia, as determined by barium swallow study 12 months after surgery. Secondary outcomes were: intraoperative and postoperative complications, use of antireflux medication, postoperative oesophageal acid exposure, quality of life, dysphagia and duration of hospital stay.
RESULTS


Some 77 patients were randomized to the suture technique and 82 patients underwent mesh repair. At 1 year, the hiatal hernia had recurred in six of 64 patients (9 per cent) in the mesh group and two of 64 (3 per cent) in the suture group (P = 0·144). Reflux symptoms, use of proton pump inhibitors and oesophageal acid exposure did not differ between the groups. At 3 years, recurrence rates were 13 and 10 per cent in the mesh and suture groups respectively (P = 0·692). Dysphagia scores decreased in both groups, but more patients had dysphagia for solid food after mesh closure (P = 0·013). Quality-of-life scores were comparable between the groups.
CONCLUSION


Tension-free crural repair with non-absorbable mesh does not reduce the incidence of recurrent hiatal hernia compared with use of sutures alone in patients undergoing laparoscopic fundoplication. NCT03730233 ( http://www.clinicaltrials.gov).",2020,"CONCLUSION


Tension-free crural repair with non-absorbable mesh does not reduce the incidence of recurrent hiatal hernia compared with use of sutures alone in patients undergoing laparoscopic fundoplication.","['77 patients', 'patients undergoing laparoscopic fundoplication', 'for GORD between January 2006 and December 2010', 'antireflux surgery', 'Patients undergoing']","['laparoscopic Nissen fundoplication', 'mesh repair', 'diaphragmatic hiatus with crural sutures or non-absorbable polytetrafluoroethylene mesh (CruraSoft®', 'Antireflux surgery', 'Tension-free crural repair with non-absorbable mesh', 'Tension-free mesh versus suture-alone cruroplasty', 'mesh versus sutures alone', 'suture technique']","['Dysphagia scores', 'recurrence rates', 'intraoperative and postoperative complications, use of antireflux medication, postoperative oesophageal acid exposure, quality of life, dysphagia and duration of hospital stay', 'incidence of recurrent hiatal hernia', 'hiatal hernia', 'Quality-of-life scores', 'recurrence of hiatal hernia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521257', 'cui_str': 'Laparoscopic fundoplication'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0399651', 'cui_str': 'Antireflux operation'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3887679', 'cui_str': 'Nissen fundoplication'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0399651', 'cui_str': 'Antireflux operation'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C3489393', 'cui_str': 'Hiatal hernia'}]",77.0,0.336243,"CONCLUSION


Tension-free crural repair with non-absorbable mesh does not reduce the incidence of recurrent hiatal hernia compared with use of sutures alone in patients undergoing laparoscopic fundoplication.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Analatos', 'Affiliation': 'Department of Clinical Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Håkanson', 'Affiliation': 'Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lundell', 'Affiliation': 'Department of Clinical Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lindblad', 'Affiliation': 'Department of Clinical Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thorell', 'Affiliation': 'Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}]",The British journal of surgery,['10.1002/bjs.11917']
2908,32936981,A pilot randomized trial of an educational intervention to increase genetic counseling and genetic testing among Latina breast cancer survivors.,"Latinas are less likely to participate in genetic counseling (GC) and genetic testing (GT) than non-Hispanic Whites. A multisite, randomized pilot study tested a culturally targeted educational intervention to increase uptake of GC/GT among Latina breast cancer (BC) survivors (N = 52). Participants were recruited in Tampa, FL and Ponce, PR and randomized to: (a) fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention). Participants in the intervention condition were also offered no-cost telephone GC followed by free GT with mail-based saliva sample collection. Participants self-reported hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress at baseline and 1- and 3-month follow-ups. We used logistic regression to examine differences in GC/GT uptake by study arm (primary outcome) and repeated measures ANOVA to examine the effects of study arm and time on HBOC knowledge and emotional distress (secondary outcomes). Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01). Study site did not predict uptake of GC (p = .08) but Ponce participants were more likely to complete GT (OR Ponce   = 4.53, 95% CI = 1.04-19.72, p = .04). ANOVAs demonstrated an increase in HBOC knowledge over time across both groups (F(2,88) = 12.24, p < .01, η p   2   = 0.22). We also found a significant interaction of study arm and time, such that intervention participants demonstrated a greater and sustained (to the 3-month follow-up) increase in knowledge than control participants (F(2,88) = 3.66, p = .03, η p   2   = 0.08). No other main or interaction effects were significant (all p's> .15). Study findings demonstrate the potential of our culturally targeted print intervention. Lessons learned from this multisite pilot study for enhancing GC/GT in Latinas include the need to attend to both access to GC/GT and individual factors such as attitudes and knowledge.",2020,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01).","['Latina breast cancer (BC) survivors (N\xa0=\xa052', 'Latina breast cancer survivors']","['culturally targeted educational intervention', 'fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention', 'educational intervention']","['hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress', 'HBOC knowledge', 'HBOC knowledge and emotional distress']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0677776', 'cui_str': 'Hereditary breast and ovarian cancer syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.0506475,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01).","[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Conley', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eida M', 'Initials': 'EM', 'LastName': 'Castro-Figueroa', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dutil', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'García', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Burgos', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Charité', 'Initials': 'C', 'LastName': 'Ricker', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Jongphil', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Georgetown Lombardi Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Kimlin Tam', 'Initials': 'KT', 'LastName': 'Ashing', 'Affiliation': 'City of Hope Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Gwendolyn P', 'Initials': 'GP', 'LastName': 'Quinn', 'Affiliation': 'New York University, Grossman School of Medicine New York, New York, NY, USA.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Vadaparampil', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1324']
2909,32936987,Predictive Value of Carbohydrate Antigen 19-9 Level Changes in Patients With Locally Advanced Rectal Cancer Treated With Neoadjuvant Chemoradiotherapy.,"PURPOSE


To explore the predictive value of carbohydrate antigen 19-9 (CA19-9) level changes after neoadjuvant chemoradiotherapy (nCRT) and after surgery in patients with locally advanced rectal cancer (LARC).
METHODS


Patients with LARC who underwent nCRT and radical surgery (2011-2016) were divided into 3 groups according to the pre-nCRT and post-nCRT CA19-9 levels as follows: normal pre-nCRT CA19-9 (normal CA19-9 group), elevated pre-nCRT and normal post-nCRT CA19-9 (normalized group), and elevated pre-nCRT and elevated post-nCRT CA19-9 (non-normalized group). The pathological nCRT response criteria included ypCR and downstaging (ypStage 0-I). Recurrence-free survival (RFS) and overall survival (OS) were analyzed.
RESULTS


A total of 721 patients were identified. The CA19-9 group was significantly associated with ypCR (n=159) and downstaging (n=347) (P<0.05). The normalized group (n=76) had worse RFS and OS than the normal CA19-9 group (n=622) and better RFS and OS than the non-normalized group (n=23) (5-year RFS: 47.0% vs 66.9% vs 81.5%, P<0.001; 5-year OS: 47.0% vs 75.4% vs 85.0%, P<0.001). In multivariate analysis, CA19-9 group and ypTNM stage were independent predictors of RFS and OS. Moreover, for the 23 patients with elevated post-nCRT CA19-9 levels, the RFS and OS of patients with normalized postoperative CA199 levels were significantly better than those of patients with elevated postoperative CA19-9 levels (P <0.05).
CONCLUSIONS


Following nCRT, CA19-9 level changes are a strong prognostic marker for long-term survival, and they may be helpful in the selection of patients who prefer more conservative surgery after chemoradiotherapy.",2020,"(5-year RFS: 47.0% vs 66.9% vs 81.5%, P<0.001; 5-year OS: 47.0% vs 75.4% vs 85.0%, P<0.001).","['721 patients were identified', 'patients with locally advanced rectal cancer (LARC', 'Patients With Locally Advanced Rectal Cancer Treated With', 'Patients with LARC who underwent nCRT and radical surgery (2011-2016', 'patients who prefer more conservative surgery after chemoradiotherapy']","['neoadjuvant chemoradiotherapy (nCRT', 'Neoadjuvant Chemoradiotherapy', 'pre-nCRT and post-nCRT CA19-9 levels as follows: normal pre-nCRT CA19-9 (normal CA19-9 group), elevated pre-nCRT and normal post-nCRT CA19-9 (normalized group), and elevated pre-nCRT and elevated post-nCRT CA19-9 (non-normalized group']","['RFS and OS', 'normalized postoperative CA199 levels', 'Recurrence-free survival (RFS) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",721.0,0.0491284,"(5-year RFS: 47.0% vs 66.9% vs 81.5%, P<0.001; 5-year OS: 47.0% vs 75.4% vs 85.0%, P<0.001).","[{'ForeName': 'Zhifang', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xingrong', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15355']
2910,32937046,Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease.,"BACKGROUND


Long-term oxygen therapy improves survival in patients with chronic obstructive pulmonary disease (COPD) and chronic severe daytime hypoxemia. However, the efficacy of oxygen therapy for the management of isolated nocturnal hypoxemia is uncertain.
METHODS


We designed this double-blind, placebo-controlled, randomized trial to determine, in patients with COPD who have nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy, whether nocturnal oxygen provided for a period of 3 to 4 years would decrease mortality or the worsening of disease such that patients meet current specifications for long-term oxygen therapy. Patients with an oxygen saturation of less than 90% for at least 30% of the recording time on nocturnal oximetry were assigned, in a 1:1 ratio, to receive either nocturnal oxygen or ambient air from a sham concentrator (placebo). The primary outcome was a composite of death from any cause or a requirement for long-term oxygen therapy as defined by the Nocturnal Oxygen Therapy Trial (NOTT) criteria in the intention-to-treat population.
RESULTS


Recruitment was stopped prematurely because of recruitment and retention difficulties after 243 patients, of a projected 600, had undergone randomization at 28 centers. At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, -3.0 percentage points; 95% confidence interval, -15.1 to 9.1).
CONCLUSIONS


Our underpowered trial provides no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with COPD. (Funded by the Canadian Institutes of Health Research; INOX ClinicalTrials.gov number, NCT01044628.).",2020,"At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, -3.0 percentage points; 95% confidence interval, -15.1 to 9.1).
","['Chronic Obstructive Pulmonary Disease', 'patients with COPD', 'patients with COPD who have nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy, whether nocturnal oxygen provided for a period of 3 to 4 years', 'patients with chronic obstructive pulmonary disease (COPD) and chronic severe daytime hypoxemia', 'Patients with an oxygen saturation of less than 90% for at least 30% of the recording time on nocturnal oximetry']","['nocturnal oxygen or ambient air from a sham concentrator (placebo', 'Nocturnal Oxygen', 'placebo', 'Long-term oxygen therapy', 'oxygen therapy']","['nocturnal oxygen', 'survival', 'composite of death from any cause or a requirement for long-term oxygen therapy as defined by the Nocturnal Oxygen Therapy Trial (NOTT) criteria in the intention-to-treat population']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0418996', 'cui_str': 'Long-term oxygen therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.675691,"At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, -3.0 percentage points; 95% confidence interval, -15.1 to 9.1).
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lacasse', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Sériès', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Corbeil', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Baltzan', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Paradis', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Simão', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Abad Fernández', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Cristóbal', 'Initials': 'C', 'LastName': 'Esteban', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Guimarães', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourbeau', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Aaron', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bernard', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'From Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) - all in Canada; Hospital Pedro Hispano-Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia-Espinho, Vila Nova de Gaia (M.G.) - both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud-Osakidetza, Bizkaia (C.E.) - both in Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2013219']
2911,32937170,"Acute exercise increases circulating IGF-1 in Alzheimer's disease patients, but not in older adults without dementia.","OBJECTIVES


Increased Insulin-like growth factor I (IGF-1) has been associated with improvement of cognitive function in response to exercise. Evidences indicate a role for IGF-1 in beta-amyloid clearance and reducing hyperphosphorylation tau in Alzheimer's disease (AD). There is a need to investigate the IGF-1 response to exercise in AD patients due to well-known potential effects of exercise on IGF-1. The aim of this study was to examine circulating IGF-1 levels in AD patients and older adults without dementia after acute exercise and to verify the associations among cardiorespiratory fitness, cognition and IGF-1 levels.
METHOD


Seventy-four older adults (40 older adults without dementia and 34 AD patients) participated in this study. The outcomes included IGF-1 plasma levels and performance in the submaximal exercise stress test. Secondary outcomes included cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol. All participants performed the incremental test on a treadmill and IGF-1 was collected before and after the exercise.
RESULTS


A tendency to the difference of baseline IGF-1 plasma levels between the groups was found. After the acute exercise AD patients also presented higher levels of circulating IGF-1 compared to the Older adults without dementia. Correlations among cardiorespiratory fitness and cognitive functions were found.
CONCLUSION


The findings suggest that AD patients and older adults respond differently to acute exercise in terms of circulating IGF-1 levels. This response seems to indicate either an IGF-1 resistance or a compensatory exercise-induced to lower IGF-1 levels in AD patients. Cardiorespiratory fitness is associated with cognitive functions.",2020,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[""Alzheimer's disease patients"", 'AD patients and older adults', ""Alzheimer's disease (AD"", 'Seventy-four older adults (40 older adults without dementia and 34 AD patients', 'AD patients and older adults without dementia after acute exercise']",['Acute exercise'],"['levels of circulating IGF-1', 'cardiorespiratory fitness and cognitive functions', 'IGF-1 levels', 'IGF-1 plasma levels and performance in the submaximal exercise stress test', 'baseline IGF-1 plasma levels', 'IGF-1 response', 'circulating IGF-1', 'cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol', 'circulating IGF-1 levels']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",74.0,0.0477822,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[{'ForeName': 'Angelica Miki', 'Initials': 'AM', 'LastName': 'Stein', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; UTFPR, Federal University of Technology - Paraná (UTFPR), Campus Curitiba, Brazil. Electronic address: angelica_stein@yahoo.com.br.'}, {'ForeName': 'Thays Martins Vital', 'Initials': 'TMV', 'LastName': 'Silva', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Instituto Federal Goiano, Campus Avançado Hidrolândia, Brazil.'}, {'ForeName': 'Flávia Gomes de Melo', 'Initials': 'FGM', 'LastName': 'Coelho', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Postgraduate Program in Physical Education, Federal University of Triangulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'André Veloso', 'Initials': 'AV', 'LastName': 'Rueda', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Camarini', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Ruth Ferreira Santos', 'Initials': 'RFS', 'LastName': 'Galduróz', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Center of Mathematics, Computing and Cognition, University Federal of ABC (UFABC), Campus São Bernardo, Brazil.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112903']
2912,32937192,"Oxytocin effects on the cognition of women with postpartum depression: A randomized, placebo-controlled clinical trial.","BACKGROUND


One of the most common mental disorders in the perinatal period is postpartum depression (PPD), which is associated with impaired emotional functioning due to alterations in different cognitive aspects including thought and facial emotion recognition (FER). Emotional impairments may affect the interaction and care offered to infants and their later development and therefore interventions with potential to minimize impairments associated with PPD are opportune. Oxytocin (OXT) was shown to have therapeutic properties associated with the promotion of affiliative and pro-social behaviors in different mental disorders. Few studies have assessed its therapeutic potential in PPD.
OBJECTIVES


To assess the effects of the acute administration of intranasal OXT (24 IU) on FER of baby faces and negative thoughts after delivery in mothers with and without PPD.
METHODS


We conducted a randomized double-blind, placebo-controlled trial with a crossover design involving mothers with PPD (N = 20) and without PPD (N = 35) in the puerperium. Participants completed a static task of FER of baby faces and a questionnaire of post-natal negative thoughts.
RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers. OXT had no effects on the rates of correct judgments or response times in the FER task, but was associated with response biases to facial happiness and the reduction of negative thoughts in mothers with PPD.
DISCUSSION/CONCLUSION


OXT may have positive effects on maternal affiliative behavior, maternal care, and mother-infant interactions as suggested by changes found in different cognitive aspects, thus minimizing the deleterious effects of PPD on child development.",2020,"RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers.","['women with postpartum depression', 'mothers with and without PPD', 'mothers with PPD', 'mothers with PPD (N\u202f=\u202f20) and without PPD (N\u202f=\u202f35) in the puerperium']","['intranasal OXT', 'OXT', 'placebo', 'Oxytocin', 'Oxytocin (OXT']","['rates of correct judgments or response times', 'FER of baby faces and negative thoughts', 'scores of negative thoughts', 'static task of FER of baby faces and a questionnaire of post-natal negative thoughts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0034042', 'cui_str': 'Puerperium'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]",,0.382587,"RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers.","[{'ForeName': 'Mariana Fortunata', 'Initials': 'MF', 'LastName': 'Donadon', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Martin-Santos', 'Affiliation': 'Servicio de Psiquiatria y Psicología, Hospital Clinic, Universidad de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'de Lima Osório', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Ribeirão Preto, SP, Brazil; National Institute for Science and Technology (INCT-TM, CNPq), Brasília, Brazil. Electronic address: flaliosorio@gmail.com.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110098']
2913,32937232,A randomised oral fluoride retention study comparing intra-oral kinetics of fluoride-containing dentifrices before and after dietary acid exposure.,"OBJECTIVE


This exploratory, randomised, single-blind, crossover, study evaluated fluoride and calcium ion concentrations and pH following use of one of two 1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse.
DESIGN


Eighteen participants used their assigned dentifrice, rinsed with DI water, then expectorate was collected. Sixty min post-brushing, participants rinsed with OJ or DI water then expectorate was collected. Saliva samples were collected pre-brushing and at 1, 5, 10, 15, 30 and 60 min post-brushing and following the 60 min OJ/DI water rinse. The pH of samples was taken.
RESULTS


Significant differences (p < 0.05) were found in salivary fluoride ion concentrations between test and comparator dentifrices at 30 and 60 min and following the 60 min OJ rinse, favouring the former. Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter. No pH differences were shown prior to OJ/water rinse. Products were generally well-tolerated.
CONCLUSIONS


Results confirmed that acid-labile fluoride is released from the oral cavity following a dietary acid challenge and showed that formulation excipients may impact on retention of such.",2020,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.",[],"['fluoride-containing dentifrices', '1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse']","['tolerated', 'salivary fluoride ion concentrations', 'salivary calcium ion concentration']",[],"[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C1849409', 'cui_str': 'Retinal detachment and occipital encephalocele'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0173050', 'cui_str': 'cocamidopropyl betaine'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0074764', 'cui_str': 'Pyrophosphate sodium'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]",,0.0288269,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Burnett', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: Gary.R.Burnett@gsk.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Nehme', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: drmnehme@gmail.com.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parkinson', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: charles.x.parkinson@gsk.com.""}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Karwal', 'Affiliation': 'GSK Consumer Healthcare, One Horizon Center, Golf Course Road, DLF Phase 5, Gurgaon, 12202, India. Electronic address: ritukarwal0283@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Badrock', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: thomas.badrock@intertek.com.'}, {'ForeName': 'Gavin Vaughan', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: gavin.thomas@intertek.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: peter.hall@intertek.com.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104891']
2914,32942914,Effects on walking performance and lower body strength by short message service guided training after stroke or transient ischemic attack (The STROKEWALK Study): a randomized controlled trial.,"OBJECTIVE


To evaluate whetherdaily mobile-phone delivered messages with training instructions during three months increase physical activity and overall mobility in patients soon after stroke or transient ischemic attack.
DESIGN


Randomised controlled trial with intention-to-treat analyses.
SETTING


University hospital. Data collection from November 2016 until December2018.
SUBJECTS


Seventy-nine patients (mean (SD) age 63.9 (10.4) years, 29 were women) were allocated to either intervention ( n  = 40) or control group ( n  = 39). Participants had to be independent (modified Ranking Scale ⩽2) and able to perform the six-minute walking test at discharge from the hospital.
INTERVENTIONS


The intervention group received standard care and daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care; that is, primary care follow-up.
MAIN MEASURES


Walking performance by six-minute walking test (m), lower body strength by five times chair-stand test (s), the short physical performance battery (0-12 points) and 10-metres walk test (m/s) were assessed at baseline and after three months.
RESULTS


The estimated median difference in the six-minute walking test was in favour of the intervention group by 30 metres (95% CI, 55 to 1; effect size 0.64;  P  = 0.037) and in the chair-stand test by 0.88 seconds (95% CI, 0.02 to 1.72; effect size 0.64;  P  = 0.034). There were no differences between groups on the short physical performance battery or in 10-metres walking time.
CONCLUSIONS


Three months of daily mobile phone text messages with guided training instructions improved composite mobility measures; that is, walking performanceand lower body strength.
CLINICAL TRIAL REGISTRY


The study is registered with ClinicalTrials.gov, number NCT02902367.",2020,"There were no differences between groups on the short physical performance battery or in 10-metres walking time.
","['University hospital', 'patients soon after stroke or transient ischemic attack', 'Seventy-nine patients (mean (SD) age 63.9 (10.4) years, 29 were women']","['standard care; that is, primary care follow-up.\nMAIN MEASURES\n\n\nWalking performance by six-minute walking test (m), lower body strength by five times chair-stand test (s), the short physical performance battery', 'standard care and daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises', 'short message service guided training']","['composite mobility measures', 'physical activity and overall mobility', 'walking performance and lower body strength', 'short physical performance battery or in 10-metres walking time']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0454361', 'cui_str': 'Lower limb exercises'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.190496,"There were no differences between groups on the short physical performance battery or in 10-metres walking time.
","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Vahlberg', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lundström', 'Affiliation': 'Department of Neuroscience, Neurology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Eriksson', 'Affiliation': 'Department of Neuroscience, Physiotherapy, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Holmbäck', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden.'}]",Clinical rehabilitation,['10.1177/0269215520954346']
2915,32942920,Ultrasound biomicroscopic features of the normal lower eyelid.,"PURPOSE


To report the ultrasound biomicroscopic features of normal lower eyelid structures.
METHODS


Thirty lower eyelids of fifteen healthy adults were randomized and prospectively subjected to Ultrasound Biomicroscopy (Quantel Aviso with 50 MHz transducer) by two independent observers (an ophthalmologist and an optometrist). The measurements were performed in upgaze, with the probe perpendicular to the lower eyelid margin in the mid-pupillary line, two limbal lines, and two canthal lines. The tarsus, orbicularis, capsulopalpebral fascia, and retractor-conjunctiva complex were assessed for two parameters: echogenicity (hyper/hypoechoic) and measurement in millimeters.
RESULTS


Mean age was 25 years (range 20-39 years), 15 (50%) were right lower eyelids and 8 were males. The first layer, skin-orbicularis complex appeared hyperechoic. The second layer was hypoechoic band which represents the tarsal plate superiorly and capsulopalpebral fascia inferiorly. This was noted to be continuous and of almost uniform thickness in the normal eyelids. The glandular structure of meibomian glands was identified in 100% cases. The hyperechoic layer below the capsulopalpebral fascia is the retractor-conjunctiva complex. The mean thickness of pretarsal and pre-septal orbicularis was 0.68 ± 0.18 mm and 0.89 ± 0.16 mm, respectively. The tarsal plate measured 0.57 ± 0.12 mm, capsulopalpebral fascia 0.42 ± 0.13 mm and the retractor-conjunctiva complex 0.79 ± 0.18 mm. On Bland-Altman analysis, the majority of the measurements had mean agreements between -0.14 mm and +0.12 mm. Anatomical differentiation was not useful in the canthal region.
CONCLUSION


Echogenicity and thickness of normal lower eyelid structures as measured by UBM are reported. The test is non-invasive, with a good inter-observer agreement.",2020,"The mean thickness of pretarsal and pre-septal orbicularis was 0.68 ± 0.18 mm and 0.89 ± 0.16 mm, respectively.","['Mean age was 25\xa0years (range 20-39\xa0years), 15 (50%) were right lower eyelids and 8 were males', 'Thirty lower eyelids of fifteen healthy adults']",['Ultrasound Biomicroscopy (Quantel Aviso with 50\xa0MHz transducer) by two independent observers (an ophthalmologist and an optometrist'],"['glandular structure of meibomian glands', 'Ultrasound biomicroscopic features', 'mean thickness of pretarsal and pre-septal orbicularis']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1301497', 'cui_str': 'Ultrasound biomicroscopy'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0029146', 'cui_str': 'Optometrist'}]","[{'cui': 'C0225353', 'cui_str': 'Glandular'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0442004', 'cui_str': 'Septal'}]",15.0,0.0316123,"The mean thickness of pretarsal and pre-septal orbicularis was 0.68 ± 0.18 mm and 0.89 ± 0.16 mm, respectively.","[{'ForeName': 'Varshitha Hemanth', 'Initials': 'VH', 'LastName': 'Vasanthapuram', 'Affiliation': 'Ophthalmic Plastic Surgery Service, L V Prasad Eye Institute , Hyderabad, India.'}, {'ForeName': 'Purabita', 'Initials': 'P', 'LastName': 'Saha', 'Affiliation': 'Ophthalmic Plastic Surgery Service, L V Prasad Eye Institute , Hyderabad, India.'}, {'ForeName': 'Ashik', 'Initials': 'A', 'LastName': 'Mohamed', 'Affiliation': 'Ophthalmic Biophysics, L V Prasad Eye Institute , Hyderabad, India.'}, {'ForeName': 'Milind N', 'Initials': 'MN', 'LastName': 'Naik', 'Affiliation': 'Ophthalmic Plastic Surgery Service, L V Prasad Eye Institute , Hyderabad, India.'}]","Orbit (Amsterdam, Netherlands)",['10.1080/01676830.2020.1812094']
2916,32942939,Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management.,"The effectiveness and predictability of 2 different oral appliance (OA) designs to reduce the respiratory event index (REI) in moderate and severe obstructive sleep apnea (OSA) patients requires elucidation. The primary aim of the trial was to determine if 2 widely used midline-traction and bilateral-thrust OA designs differ in effectiveness to reduce the REI within a single test population categorized by OSA severity. Moderate and severe adult OSA patients, who were previously prescribed continuous positive airway pressure therapy (CPAP) but were dissatisfied with it ( n  = 56), were studied by home-polygraphy in a randomized crossover trial using either midline-traction with restricted mouth opening (MR) or bilateral thrust with opening permitted (BP) design OAs. OAs were used nightly for 4 wk (T2) followed by a 1-wk washout period, then 4 wk (T4) using the alternate OA. REI and oxygen saturation (SaO 2 ) were primary outcomes, while predictability and efficacy comparison of the 2 OAs were secondary outcomes. Thirty-six participants had used MR and BP OAs during both 4-wk study legs. Twenty (55.6%) MR OA-using participants, 25 (69.4%) BP OA-using participants, and 16 (44.4%) participants using both OAs had significant REI reductions. Overall baseline (T0) median REI (interquartile range) of 33.7 (20.7-54.9) was reduced to 18.0 (8.5-19.4) at T2 and to 12.5 (8.2-15.9) at T4 ( P  < 0.001). Comparison of the 2 sequence groups' (MR-BP and BP-MR) REI showed the median differences between T0 and T2 and T4 were highly significant ( P  < 0.001). Regression analysis predicted about half of all users will have REIs between 8 and 16 after 2 mo. Baseline overjet measures >2.9 mm predicted greater OA advancement at T4. Mean and minimum SaO 2  did not change significantly from T0 to T2 or T4. MR and BP OA designs similarly attenuated REI in moderate and severe OSA individuals who completed the 8-wk study protocol with greater REI reduction in those with severe OSA (ClinicalTrials.gov NCT03219034).",2020,Mean and minimum SaO 2  did not change significantly from T0 to T2 or T4.,"['moderate and severe OSA individuals', 'Moderate and severe adult OSA patients, who were previously prescribed continuous positive airway pressure therapy (CPAP) but were dissatisfied with it ( n  = 56', 'moderate and severe obstructive sleep apnea (OSA) patients']","['oral appliance (OA', 'midline-traction and bilateral-thrust OA designs', '2 Self-Titrated Oral Appliances', 'midline-traction with restricted mouth opening (MR) or bilateral thrust with opening permitted (BP) design OAs']","['Mean and minimum SaO 2', 'MR and BP OAs', 'Overall baseline (T0) median REI', 'OA advancement', ' (MR-BP and BP-MR', 'REI and oxygen saturation (SaO 2 ']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",2.0,0.146977,Mean and minimum SaO 2  did not change significantly from T0 to T2 or T4.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schneiderman', 'Affiliation': 'Department of Biomedical Sciences, Texas A&M University College of Dentistry, Dallas, TX, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schramm', 'Affiliation': 'Department of Biomedical Sciences, Texas A&M University College of Dentistry, Dallas, TX, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Department of Comprehensive Dentistry, Texas A&M University College of Dentistry, Dallas, TX, USA.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Wilson', 'Affiliation': 'Department of Comprehensive Dentistry, Texas A&M University College of Dentistry, Dallas, TX, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Moura', 'Affiliation': 'Department of Diagnostic Sciences, Texas A&M University College of Dentistry, Dallas, TX, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'German', 'Affiliation': 'Department of Biomedical Sciences, Texas A&M University College of Dentistry, Dallas, TX, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Departments of Academic Affairs and Dental Hygiene, Texas A&M University College of Dentistry, Dallas, TX, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Newton', 'Affiliation': 'Department of Biomedical Sciences, Texas A&M University College of Dentistry, Dallas, TX, USA.'}]",Journal of dental research,['10.1177/0022034520956977']
2917,32942949,Effects of Qigong Exercise on Physical and Psychological Health among African Americans.,"Interventions are needed to address physical and psychological health in middle-aged and older African Americans (AAs). The purpose of this pilot study was to evaluate the feasibility and potential benefits of an eight-week Qigong exercise on physical ability and function, balance, frailty, depression and anxiety, and spiritual well-being in AAs using a single-group design. Fifteen AAs with a mean age of 64 years received Qigong exercise over 16 semi-weekly, one-hour sessions. The majority were female (93.3%) and college-level educated (53.3%). Repeat chair stands, physical function, and spiritual well-being improved significantly ( p  < .05) with effect sizes ranging from .45 to .87. Over 52% of participants showed improved depression scores, fast gait speed, and standing balance. Nearly 42% demonstrated some frailty improvement over baseline. No adverse events were reported. Qigong exercise potentially improves the physical ability and function, and spiritual well-being of AAs and needs further testing in a randomized clinical trial.",2020,"Repeat chair stands, physical function, and spiritual well-being improved significantly ( p  < .05) with effect sizes ranging from .45 to .87.","['Fifteen AAs with a mean age of 64 years received', 'middle-aged and older African Americans (AAs', 'African Americans']","['Qigong Exercise', 'Qigong exercise', 'eight-week Qigong exercise']","['physical ability and function, balance, frailty, depression and anxiety, and spiritual well-being in AAs', 'adverse events', 'Physical and Psychological Health', 'frailty improvement', 'physical ability and function, and spiritual well-being of AAs', 'depression scores, fast gait speed, and standing balance']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",,0.0174683,"Repeat chair stands, physical function, and spiritual well-being improved significantly ( p  < .05) with effect sizes ranging from .45 to .87.","[{'ForeName': 'Pei-Shiun', 'Initials': 'PS', 'LastName': 'Chang', 'Affiliation': 'Department of Community and Health Systems, School of Nursing, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, Indiana University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Chi Mai', 'Initials': 'CM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Community and Health Systems, School of Nursing, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Youngnok', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Department of Community and Health Systems, School of Nursing, Indiana University Bloomington, Bloomington, IN, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Luciani', 'Affiliation': 'School of Nursing, Indiana University Indianapolis, Indianapolis, IN, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ofner', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, United States.'}, {'ForeName': 'Savannah', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Department of Community and Health Systems, School of Nursing, Indiana University Bloomington, Bloomington, IN, United States.'}]",Western journal of nursing research,['10.1177/0193945920959067']
2918,32937045,"Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis.","BACKGROUND


In adults with active lupus nephritis, the efficacy and safety of intravenous belimumab as compared with placebo, when added to standard therapy (mycophenolate mofetil or cyclophosphamide-azathioprine), are unknown.
METHODS


In a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 104-week trial conducted at 107 sites in 21 countries, we assigned adults with biopsy-proven, active lupus nephritis in a 1:1 ratio to receive intravenous belimumab (at a dose of 10 mg per kilogram of body weight) or matching placebo, in addition to standard therapy. The primary end point at week 104 was a primary efficacy renal response (a ratio of urinary protein to creatinine of ≤0.7, an estimated glomerular filtration rate [eGFR] that was no worse than 20% below the value before the renal flare (pre-flare value) or ≥60 ml per minute per 1.73 m 2  of body-surface area, and no use of rescue therapy), and the major secondary end point was a complete renal response (a ratio of urinary protein to creatinine of <0.5, an eGFR that was no worse than 10% below the pre-flare value or ≥90 ml per minute per 1.73 m 2 , and no use of rescue therapy). The time to a renal-related event or death was assessed.
RESULTS


A total of 448 patients underwent randomization (224 to the belimumab group and 224 to the placebo group). At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P = 0.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P = 0.02). The risk of a renal-related event or death was lower among patients who received belimumab than among those who received placebo (hazard ratio, 0.51; 95% CI, 0.34 to 0.77; P = 0.001). The safety profile of belimumab was consistent with that in previous trials.
CONCLUSIONS


In this trial involving patients with active lupus nephritis, more patients who received belimumab plus standard therapy had a primary efficacy renal response than those who received standard therapy alone. (Funded by GlaxoSmithKline; BLISS-LN ClinicalTrials.gov number, NCT01639339.).",2020,"At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P = 0.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P = 0.02).","['patients with active lupus nephritis', '448 patients underwent randomization (224 to the belimumab group and 224 to the placebo group', 'Lupus Nephritis', 'adults with active lupus nephritis', '107 sites in 21 countries, we assigned adults with biopsy-proven, active lupus nephritis in a 1:1 ratio to receive']","['standard therapy (mycophenolate mofetil or cyclophosphamide-azathioprine', 'standard therapy alone', 'placebo', 'Belimumab', 'intravenous belimumab', 'belimumab plus standard therapy']","['primary efficacy renal response', 'complete renal response', 'efficacy renal response (a ratio of urinary protein to creatinine of ≤0.7, an estimated glomerular filtration rate [eGFR', 'risk of a renal-related event or death', 'efficacy renal response', 'time to a renal-related event or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",448.0,0.62045,"At week 104, significantly more patients in the belimumab group than in the placebo group had a primary efficacy renal response (43% vs. 32%; odds ratio, 1.6; 95% confidence interval [CI], 1.0 to 2.3; P = 0.03) and a complete renal response (30% vs. 20%; odds ratio, 1.7; 95% CI, 1.1 to 2.7; P = 0.02).","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Furie', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Brad H', 'Initials': 'BH', 'LastName': 'Rovin', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Houssiau', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Malvar', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Y K Onno', 'Initials': 'YKO', 'LastName': 'Teng', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Contreras', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Zahir', 'Initials': 'Z', 'LastName': 'Amoura', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Xueqing', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Chi-Chiu', 'Initials': 'CC', 'LastName': 'Mok', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Mittermayer B', 'Initials': 'MB', 'LastName': 'Santiago', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Green', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Beulah', 'Initials': 'B', 'LastName': 'Ji', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Christi', 'Initials': 'C', 'LastName': 'Kleoudis', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Burriss', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Barnett', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Roth', 'Affiliation': ""From the Division of Rheumatology, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (R.F.); the Division of Nephrology, Ohio State University, Columbus (B.H.R.); Pôle de Pathologies Rhumatismales Inflammatoires et Systémiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Service de Rhumatologie, Cliniques Universitaires Saint-Luc - both in Brussels (F.H.); Organización Médica de Investigación, Buenos Aires (A.M.); the Department of Internal Medicine, Section of Nephrology, Leiden University Medical Center, Leiden, the Netherlands (Y.K.O.T.); the Division of Nephrology, Division of Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami (G.C.); Sorbonne Université, INSERM Unité 1135 (Z.A.), and Assistance Publique-Hôpitaux de Paris Sorbonne Université, Service de Médecine Interne 2, Institut Endocrinologie, Maladies Métaboliques et Médecine Interne, Centre de Référence National du Lupus et Syndrome des Antiphospholipides, Hôpital Pitié-Salpêtrière (Z.A.) - both in Paris; the Department of Nephrology, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou (X.Y.), and the Department of Medicine, Tuen Mun Hospital, Hong Kong (C.C.M.) - both in China; Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil (M.B.S.); the Division of Rheumatology, New York University School of Medicine, New York (A.S.); GlaxoSmithKline, Stockley Park, Uxbridge, United Kingdom (Y.G., B.J.); Parexel, Durham, NC (C.K.); and GlaxoSmithKline, Collegeville, PA (S.W.B., C.B., D.A.R.).""}]",The New England journal of medicine,['10.1056/NEJMoa2001180']
2919,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE


This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN


A randomized controlled study.
PARTICIPANTS


One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES


Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS


Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS


Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION


This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: amohamed@gelisim.edu.tr.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
2920,32937598,School-Based Exercise Intervention Improves Blood Pressure and Parameters of Arterial Stiffness in Children: A Randomized Controlled Trial.,"PURPOSE


To evaluate the effectiveness of a school-based exercise intervention on endurance performance (EP), blood pressure (BP), and arterial stiffness in children.
METHODS


A total of 105 students (mean age = 8.2 [0.6] y; 51% girls; body mass index = 17.8 [3.0] kg/m2) were randomized to the intervention group (IG, n = 51) and control group (CG, n = 54). During a 37-week experimental period, the IG received an exercise intervention (2 × 45 min/wk) in addition to their regular school physical education class (3 × 45 min/wk). EP, peripheral and central BP, pulse pressure, augmentation pressure, augmentation index, and aortic pulse wave velocity were assessed.
RESULTS


Following the intervention, significant changes (P < .05) in EP, peripheral and central systolic BP, pulse pressure, augmentation pressure, augmentation index, and aortic pulse wave velocity were found in the IG. Children in the CG displayed significant changes in peripheral and central diastolic BP. An analysis of the baseline-to-post changes revealed significant between-group differences in EP (P < .001), pulse pressure (P = .028), augmentation pressure (P = .007), and aortic pulse wave velocity (P = .037) that favored the IG and in peripheral and central diastolic BP that favored the CG.
CONCLUSION


The school-based exercise intervention had beneficial effects not only on EP but also on different hemodynamic parameters.",2020,"Following the intervention, significant changes (P < .05) in EP, peripheral and central systolic BP, pulse pressure, augmentation pressure, augmentation index, and aortic pulse wave velocity were found in the IG.","['children', 'y; 51% girls; body mass index = 17.8 [3.0]\xa0kg/m2', 'Children', 'A total of 105 students (mean age = 8.2 [0.6']","['exercise intervention', 'School-Based Exercise Intervention', 'school-based exercise intervention']","['peripheral and central diastolic BP', 'EP, peripheral and central BP, pulse pressure, augmentation pressure, augmentation index, and aortic pulse wave velocity', 'Blood Pressure and Parameters of Arterial Stiffness', 'endurance performance (EP), blood pressure (BP), and arterial stiffness', 'pulse pressure', 'EP, peripheral and central systolic BP, pulse pressure, augmentation pressure, augmentation index, and aortic pulse wave velocity', 'EP', 'aortic pulse wave velocity', 'augmentation pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068883', 'cui_str': '0.6'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",105.0,0.0258236,"Following the intervention, significant changes (P < .05) in EP, peripheral and central systolic BP, pulse pressure, augmentation pressure, augmentation index, and aortic pulse wave velocity were found in the IG.","[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Ketelhut', 'Affiliation': 'Martin-Luther-University Halle-Wittenberg.'}, {'ForeName': 'Sebastian R', 'Initials': 'SR', 'LastName': 'Ketelhut', 'Affiliation': 'Charité-University Medicine Berlin.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ketelhut', 'Affiliation': 'MSB Medical School Berlin.'}]",Pediatric exercise science,['10.1123/pes.2020-0053']
2921,32937599,Concurrent Heat and Intermittent Hypoxic Training: No Additional Performance Benefit Over Temperate Training.,"PURPOSE


To examine whether concurrent heat and intermittent hypoxic training can improve endurance performance and physiological responses relative to independent heat or temperate interval training.
METHODS


Well-trained male cyclists (N = 29) completed 3 weeks of moderate- to high-intensity interval training (4 × 60 min·wk-1) in 1 of 3 conditions: (1) heat (HOT: 32°C, 50% relative humidity, 20.8% fraction of inspired oxygen, (2) heat + hypoxia (H+H: 32°C, 50% relative humidity, 16.2% fraction of inspired oxygen), or (3) temperate environment (CONT: 22°C, 50% relative humidity, 20.8% fraction of inspired oxygen). Performance 20-km time trials (TTs) were conducted in both temperate (TTtemperate) and assigned condition (TTenvironment) before (base), immediately after (mid), and after a 3-week taper (end). Measures of hemoglobin mass, plasma volume, and blood volume were also assessed.
RESULTS


There was improved 20-km TT performance to a similar extent across all groups in both TTtemperate (mean ±90% confidence interval HOT, -2.8% ±1.8%; H+H, -2.0% ±1.5%; CONT, -2.0% ±1.8%) and TTenvironment (HOT, -3.3% ±1.7%; H+H, -3.1% ±1.6%; CONT, -3.2% ±1.1%). Plasma volume (HOT, 3.8% ±4.7%; H+H, 3.3% ±4.7%) and blood volume (HOT, 3.0% ±4.1%; H+H, 4.6% ±3.9%) were both increased at mid in HOT and H+H over CONT. Increased hemoglobin mass was observed in H+H only (3.0% ±1.8%).
CONCLUSION


Three weeks of interval training in heat, concurrent heat and hypoxia, or temperate environments improve 20-km TT performance to the same extent. Despite indications of physiological adaptations, the addition of independent heat or concurrent heat and hypoxia provided no greater performance benefits in a temperate environment than temperate training alone.",2020,"There was improved 20-km TT performance to a similar extent across all groups in both TTtemperate (mean ±90% confidence interval HOT, -2.8% ±1.8%; H+H, -2.0% ±1.5%; CONT, -2.0% ±1.8%) and TTenvironment (HOT, -3.3% ±1.7%; H+H, -3.1% ±1.6%; CONT, -3.2% ±1.1%).",['Well-trained male cyclists (N = 29) completed 3 weeks of'],"['Concurrent Heat and Intermittent Hypoxic Training', 'concurrent heat and intermittent hypoxic training', 'moderate- to high-intensity interval training (4 × 60 min·wk-1) in 1 of 3 conditions: (1)\xa0heat (HOT: 32°C, 50% relative humidity, 20.8% fraction of inspired oxygen, (2)\xa0heat + hypoxia (H+H: 32°C, 50% relative humidity, 16.2% fraction of inspired oxygen), or (3)\xa0temperate environment (CONT: 22°C, 50% relative humidity, 20.8% fraction of inspired oxygen']","['Increased hemoglobin mass', '20-km TT performance', 'blood volume', 'Plasma volume', 'hemoglobin mass, plasma volume, and blood volume', 'Performance 20-km time trials (TTs']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0428696', 'cui_str': 'Relative humidity'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0562524', 'cui_str': 'Temperate environment'}]","[{'cui': 'C0549448', 'cui_str': 'Increased hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",,0.0243829,"There was improved 20-km TT performance to a similar extent across all groups in both TTtemperate (mean ±90% confidence interval HOT, -2.8% ±1.8%; H+H, -2.0% ±1.5%; CONT, -2.0% ±1.8%) and TTenvironment (HOT, -3.3% ±1.7%; H+H, -3.1% ±1.6%; CONT, -3.2% ±1.1%).","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'McCleave', 'Affiliation': ''}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Slattery', 'Affiliation': ''}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Duffield', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Crowcroft', 'Affiliation': ''}, {'ForeName': 'Chris R', 'Initials': 'CR', 'LastName': 'Abbiss', 'Affiliation': ''}, {'ForeName': 'Lee K', 'Initials': 'LK', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Coutts', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0277']
2922,32937620,The Effects of a Simulated Workday of Prolonged Sitting on Seated versus Supine Blood Pressure and Pulse Wave Velocity in Adults with Overweight/Obesity and Elevated Blood Pressure.,"We evaluated the effects of a simulated workday of prolonged sitting on blood pressure (BP) and pulse wave velocity (PWV) and examined whether posture (seated vs. supine) affected responses. Participants (n = 25) were adults, with overweight/obesity and elevated BP, and performed seated desk work for 7.5 h. BP and PWV were measured in seated and supine postures at baseline (7:15 a.m.), midday (12:05 p.m.), and afternoon (4:45 p.m.). Generalized linear mixed models evaluated the effects of prolonged sitting on BP and PWV within each posture and interactions by posture and sex. In the recommended postures, seated BP and supine carotid-femoral pulse wave velocity (cfPWV) and carotid-ankle pulse wave velocity (caPWV), but not carotid-radial pulse wave velocity (crPWV), significantly increased over the simulated seated workday (all p < 0.05; effect sizes [d] ranged from 0.25 to 0.44). Whilst no posture-by-time interactions were observed (p > 0.05), BP, caPWV, and crPWV were higher when seated versus supine (main effects of posture p < 0.05; d ranged from 0.30 to 1.04). Exploratory analysis revealed that females had greater seated BP responses (p for interaction <0.05); seated PWV and supine BP and PWV responses were similar by sex (p for interaction >0.05). A simulated workday of prolonged sitting increased seated BP and supine cfPWV and caPWV, and posture minimally influenced these responses. These results add to the evidence suggesting a deleterious effect of prolonged sitting on cardiovascular health.",2020,Exploratory analysis revealed that females had greater seated BP responses (p for interaction <0.05); seated PWV and supine BP and PWV responses were similar by sex (p for interaction >0.05).,"['Adults with Overweight/Obesity and Elevated Blood Pressure', 'Participants (n = 25) were adults, with overweight/obesity and elevated BP, and performed seated desk work for 7.5 h']","['Simulated Workday of Prolonged Sitting on Seated versus Supine Blood Pressure and Pulse Wave Velocity', 'simulated workday of prolonged sitting']","['seated PWV and supine BP and PWV responses', 'seated BP responses', 'BP and PWV', 'carotid-radial pulse wave velocity (crPWV', 'cardiovascular health', 'BP, caPWV, and crPWV', 'seated BP and supine carotid-femoral pulse wave velocity (cfPWV) and carotid-ankle pulse wave velocity (caPWV', 'blood pressure (BP) and pulse wave velocity (PWV']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0232142', 'cui_str': 'Radial pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",25.0,0.0541299,Exploratory analysis revealed that females had greater seated BP responses (p for interaction <0.05); seated PWV and supine BP and PWV responses were similar by sex (p for interaction >0.05).,"[{'ForeName': 'Abdullah Bandar', 'Initials': 'AB', 'LastName': 'Alansare', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA, aba79@pitt.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kowalsky', 'Affiliation': 'Department of Health and Kinesiology, College of Education and Human Performance, Texas A&M University-Kingsville, Kingsville, Texas, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Jones', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sophy J', 'Initials': 'SJ', 'LastName': 'Perdomo', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Sport and Exercise, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bethany Barone', 'Initials': 'BB', 'LastName': 'Gibbs', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",Journal of vascular research,['10.1159/000510294']
2923,32937988,Mitochondrial DNA Parameters in Blood of Infants Receiving Lopinavir/Ritonavir or Lamivudine Prophylaxis to Prevent Breastfeeding Transmission of HIV-1.,"Children who are human immunodeficiency virus (HIV)-exposed but uninfected (CHEU) accumulate maternal HIV and antiretroviral exposures through pregnancy, postnatal prophylaxis, and breastfeeding. Here, we compared the dynamics of mitochondrial DNA (mtDNA) parameters in African breastfed CHEU receiving lopinavir/ritonavir (LPV/r) or lamivudine (3TC) pre-exposure prophylaxis during the first year of life. The number of mtDNA copies per cell (MCN) and the proportion of deleted mtDNA (MDD) were assessed at day 7 and at week 50 post-delivery (PrEP group). mtDNA depletion was defined as a 50% or more decrease from the initial value, and mtDNA deletions was the detection of mtDNA molecules with large DNA fragment loss. We also performed a sub-analysis with CHEU who did not receive a prophylactic treatment in South Africa (control group). From day seven to week 50, MCN decreased with a median of 41.7% (interquartile range, IQR: 12.1; 64.4) in the PrEP group. The proportion of children with mtDNA depletion was not significantly different between the two prophylactic regimens. Poisson regressions showed that LPV/r and 3TC were associated with mtDNA depletion (reference: control group; LPV/r: PR = 1.75 (CI95%: 1.15-2.68),  p  < 0.01; 3TC: PR = 1.54 (CI95%: 1.00-2.37),  p  = 0.05). Moreover, the proportion of children with MDD was unexpectedly high before randomisation in both groups. Long-term health impacts of these mitochondrial DNA parameters should be investigated further for both CHEU and HIV-infected children receiving LPV/r- or 3TC- based regimens.",2020,"Poisson regressions showed that LPV/r and 3TC were associated with mtDNA depletion (reference: control group; LPV/r: PR = 1.75 (CI95%: 1.15-2.68),  p  < 0.01; 3TC: PR = 1.54 (CI95%: 1.00-2.37),  p  = 0.05).","['African breastfed CHEU receiving', 'Children who are human immunodeficiency virus (HIV)-exposed but uninfected (CHEU) accumulate maternal HIV and antiretroviral exposures through pregnancy, postnatal prophylaxis, and breastfeeding']","['Lopinavir/Ritonavir or Lamivudine Prophylaxis', 'lopinavir/ritonavir (LPV/r) or lamivudine (3TC']","['mtDNA depletion', 'proportion of children with mtDNA depletion', 'proportion of children with MDD', 'number of mtDNA copies per cell (MCN) and the proportion of deleted mtDNA (MDD']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0342782', 'cui_str': 'Depletion of mitochondrial DNA'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1269683', 'cui_str': 'Major depressive disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0274673,"Poisson regressions showed that LPV/r and 3TC were associated with mtDNA depletion (reference: control group; LPV/r: PR = 1.75 (CI95%: 1.15-2.68),  p  < 0.01; 3TC: PR = 1.54 (CI95%: 1.00-2.37),  p  = 0.05).","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Monnin', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Centre Hospitalier Universitaire, 34934 Montpellier, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Periès', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}, {'ForeName': 'Roselyne', 'Initials': 'R', 'LastName': 'Vallo', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meda', 'Affiliation': 'Centre MURAZ, Bobo-Dioulasso 01 B.P. 390, Burkina Faso.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Singata-Madliki', 'Affiliation': 'Effective Care Research Unit, Cecilia Makiwane Hospital, University of Fort Hare, East London 5201, South Africa.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Tumwine', 'Affiliation': 'Department of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala 7062, Uganda.'}, {'ForeName': 'Chipepo', 'Initials': 'C', 'LastName': 'Kankasa', 'Affiliation': 'Department of Paediatric and Child Health, University Teaching Hospital, Lusaka PO Box 50110, Zambia.'}, {'ForeName': 'Nobubelo', 'Initials': 'N', 'LastName': 'Ngandu', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Cape Town 7501, South Africa.'}, {'ForeName': 'Ameena', 'Initials': 'A', 'LastName': 'Goga', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Cape Town 7501, South Africa.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Reynier', 'Affiliation': 'Département de Biochimie et Génétique, Centre Hospitalier Universitaire, 49933 Angers, France.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Centre for International Health, Faculty of Medicine, University of Bergen, 5009 Bergen, Norway.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van de Perre', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Centre Hospitalier Universitaire, 34934 Montpellier, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Molès', 'Affiliation': 'Pathogenèse et Contrôle des Infections Chroniques, INSERM U1058, Université Montpellier, Etablissement Français du Sang, 34934 Montpellier, France.'}]",Journal of clinical medicine,['10.3390/jcm9092972']
2924,32938280,Efficacy of different treatment times of mild cerebral hypothermia on oxidative factors and neuroprotective effects in neonatal patients with moderate/severe hypoxic-ischemic encephalopathy.,"OBJECTIVE


To investigate the efficacy of different treatment times of mild cerebral hypothermia for treating moderate/severe hypoxic-ischemic encephalopathy (HIE) in neonatal patients and its effects on oxidative factors.
METHODS


This prospective, randomized, controlled study included 92 neonatal patients with moderate/severe HIE and 30 controls. The patients with HIE received routine treatment, 48 hours of hypothermia, or 72 hours of hypothermia.
RESULTS


Superoxide dismutase (SOD) values were significantly lower and malondialdehyde (MDA) and neuron-specific enolase (NSE) values were higher in patients with HIE than in controls before the study. After 24, 48, and 72 hours of treatment, SOD values in all patients with HIE gradually increased and MDA and NSE values gradually decreased. At 3, 7, and 10 days, the Neonatal Behavioral Neurological Assessment scores were highest in the mild hypothermia for 72 hours group than in the other groups. The Mental and Psychomotor Development Indices scores of the Bayley Scales were significantly higher in the mild hypothermia for 72 hours group than in the other groups.
CONCLUSION


Hypothermia treatment of 72 hours is better than 48 hours for improving oxidative conditions, reducing NSE values, and improving neurological behavior and development for neonates with moderate/severe HIE.",2020,"The Mental and Psychomotor Development Indices scores of the Bayley Scales were significantly higher in the mild hypothermia for 72 hours group than in the other groups.
","['92 neonatal patients with moderate/severe HIE and 30 controls', 'neonatal patients with moderate/severe hypoxic-ischemic encephalopathy']",['mild cerebral hypothermia'],"['Mental and Psychomotor Development Indices scores of the Bayley Scales', 'oxidative conditions, reducing NSE values', 'Superoxide dismutase (SOD) values', 'Neonatal Behavioral Neurological Assessment scores', 'SOD values', 'MDA and NSE values', 'neurological behavior', 'neuron-specific enolase (NSE) values']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C2712360', 'cui_str': 'Severe hypoxic ischemic encephalopathy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}]","[{'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",92.0,0.0323026,"The Mental and Psychomotor Development Indices scores of the Bayley Scales were significantly higher in the mild hypothermia for 72 hours group than in the other groups.
","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': ""Department of Neonatology, The First People's Hospital of Lianyungang, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, The First People's Hospital of Lianyungang, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, Jiangsu, China.""}]",The Journal of international medical research,['10.1177/0300060520943770']
2925,32938285,Safety and feasibility of trial of labor in pregnant women with cesarean scar diverticulum.,"OBJECTIVE


Literature on trial of labor after cesarean section (TOLAC) in women with isthmoceles is scarce because of complications associated with the procedure. This study investigated TOLAC's safety and feasibility in patients with isthmoceles.
METHODS


The study group comprised 34 pregnant women with isthmoceles who vaginally delivered. The control group comprised 102 pregnant women without isthmoceles who vaginally delivered during the same period. Scar diverticula were measured using color Doppler ultrasonography; between-group delivery outcomes were compared.
RESULTS


Of the study group patients, 27/34 had isthmoceles diagnosed by ultrasound before pregnancy. Nineteen (70.37%) of these patients had mild defects and eight (29.63%) had moderate defects. The scar diverticula's mean length, depth, and width were 1.05 ± 0.62, 0.54 ± 0.28, and 1.20 ± 0.70 cm, respectively. The residual muscle layer's mean thickness was 0.27 ± 0.07 cm. The mean diverticulum depth/residual muscular thickness ratio was 2.39 ± 2.58. The duration of the first stage of labor was significantly shorter and the neonatal weight was significantly lower in the study group than control group.
CONCLUSION


Successful vaginal delivery is possible for women with mild and moderate isthmoceles. Further large-scale studies are needed to improve TOLAC's safety in pregnant women with isthmoceles.",2020,"The duration of the first stage of labor was significantly shorter and the neonatal weight was significantly lower in the study group than control group.
","['102 pregnant women without isthmoceles who vaginally delivered during the same period', 'pregnant women with cesarean scar diverticulum', '34 pregnant women with isthmoceles who vaginally delivered', 'pregnant women with isthmoceles', 'women with mild and moderate isthmoceles', 'women with isthmoceles', 'patients with isthmoceles']","['labor', 'labor after cesarean section (TOLAC', 'TOLAC']","['mean diverticulum depth/residual muscular thickness ratio', 'Scar diverticula', ""TOLAC's safety"", 'neonatal weight', 'duration of the first stage of labor']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0012817', 'cui_str': 'Diverticulum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012817', 'cui_str': 'Diverticulum'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}]",102.0,0.0785911,"The duration of the first stage of labor was significantly shorter and the neonatal weight was significantly lower in the study group than control group.
","[{'ForeName': 'Xiuqiong', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Zhaozhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Xuechun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Lianghui', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Obstetrics, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Ultrasound, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ultrasound, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.'}]",The Journal of international medical research,['10.1177/0300060520954993']
2926,32938325,Enhanced Performance Stabilization Increases Performance Variability in a Virtual Interception Task.,"Performing a motor task depends on the level of performance stabilization and movement control, and both aspects of motor behavior are related to motor learning (retention and transfer) and adaptation (predictable and unpredictable perturbations). Yet few studies have further investigated the underlying dynamics that may elicit these benefits. In this study, we investigated the effects of two levels of performance stabilization on motor performance and control while learning to intercept a virtual moving target. We randomly divided 40 participants of both sexes ( M age  = 26.02 years,  SD  = 2.02) into a Stabilization Group (SG) and a Superstabilization Group (SSG). We considered the performance stabilized when a moving target was intercepted three times in a row and superstabilized when the same criterion was repeated six times. We analyzed outcome variables related to performance accuracy (absolute spatial error) and variability(coefficient of variation) and motor control (relative time to peak velocity-tPV% and its coefficient of variation) on both the first and last blocks of practice trials. Both groups showed comparable increases in performance accuracy from the first to the last block ( p  = .001,  η p 2  = 1.00), but SSG presented higher variability than SG ( p  = .05,  η p 2  = .70). Concerning motor control, both groups started the experiment with low tPV% and finished with comparably high tPV% and variability. Thus, although practicing two levels of performance stabilization led to similar performance accuracy and movement control, superstabilization resulted in higher performance variability with no loss of accuracy. Enhanced stabilization may increase the ability to adapt to environmental changes, but more research is needed to demonstrate this. These findings add to an understanding of the relationship between levels of performance stabilization and performance variability and may have implications for professional interventions (e.g. sports, rehabilitation) in considering the benefits of practice beyond performance stabilization.",2020,"Both groups showed comparable increases in performance accuracy from the first to the last block ( p  = .001,  η p 2  = 1.00), but SSG presented higher variability than SG ( p  = .05,  η p 2  = .70).","['40 participants of both sexes ( M age \u2009=\u200926.02 years,  SD \u2009=\u20092.02) into a']",['Stabilization Group (SG) and a Superstabilization Group (SSG'],"['motor learning (retention and transfer) and adaptation (predictable and unpredictable perturbations', 'performance accuracy', 'performance accuracy (absolute spatial error) and variability(coefficient of variation) and motor control (relative time to peak velocity']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439564', 'cui_str': 'Relative time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",40.0,0.0370196,"Both groups showed comparable increases in performance accuracy from the first to the last block ( p  = .001,  η p 2  = 1.00), but SSG presented higher variability than SG ( p  = .05,  η p 2  = .70).","[{'ForeName': 'Crislaine Rangel', 'Initials': 'CR', 'LastName': 'Couto', 'Affiliation': 'Sports Department, Universidade Federal de Minas Gerais.'}, {'ForeName': 'Claudio Manoel Ferreira', 'Initials': 'CMF', 'LastName': 'Leite', 'Affiliation': 'Department of Physical Education and Health Sciences, Universidade Federal de São João del-Rei.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Campos', 'Affiliation': 'Sports Department, Universidade Federal de Minas Gerais.'}, {'ForeName': 'Leonardo Luiz', 'Initials': 'LL', 'LastName': 'Portes', 'Affiliation': 'Department of Mathematics and Statistics, University of Western Australia.'}, {'ForeName': 'Suziane Peixoto Dos', 'Initials': 'SPD', 'LastName': 'Santos', 'Affiliation': 'Department of Sports Science, Universidade Federal do Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Madson Pereira', 'Initials': 'MP', 'LastName': 'Cruz', 'Affiliation': 'Sports Department, Universidade Federal de Minas Gerais.'}, {'ForeName': 'Maria Carolina Andrade', 'Initials': 'MCA', 'LastName': 'Sousa', 'Affiliation': 'Sports Department, Universidade Federal de Minas Gerais.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Ugrinowitsch', 'Affiliation': 'Sports Department, Universidade Federal de Minas Gerais.'}]",Perceptual and motor skills,['10.1177/0031512520954959']
2927,32938332,Effect of Self-Controlled Practice on Neuro-Cortical Dynamics During the Processing of Visual Performance Feedback.,"Evidence has accumulated that learners participating in self-controlled practice can both acquire skills and process task-relevant information more effectively than those participating in externally controlled practice. However, the impact of self-controlled practice on neuro-cognitive information processing during visual performance-related feedback has received limited investigation. We expected that individuals participating in self-controlled practice would exhibit elevated neuro-cognitive information processing, as assessed via electroencephalography (EEG), compared with those engaged with externally controlled practice. Participants practiced a golf-putting task under self-controlled or externally controlled (yoked) conditions while EEG data were recorded. Results indicated that EEG theta power was maintained at an elevated level during the feedback period in the self-controlled group relative to the yoked group. The yoked group did not display increases in theta power until the time at which the ball stopped. Both groups displayed similar improvement over the course of the experiment. Correlational analyses revealed that performance improvement within each group was related differently to EEG theta power. Specifically, the self-controlled group displayed positive relationships between theta power and performance improvement, while the yoked group displayed negative relationships. These results have implications regarding the relative effectiveness of self-controlled and externally controlled practice and the instances in which they may provide the most benefit.",2020,Evidence has accumulated that learners participating in self-controlled practice can both acquire skills and process task-relevant information more effectively than those participating in externally controlled practice.,['individuals participating in self-controlled practice'],['Self-Controlled Practice'],['EEG theta power'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",,0.0288256,Evidence has accumulated that learners participating in self-controlled practice can both acquire skills and process task-relevant information more effectively than those participating in externally controlled practice.,"[{'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Jaquess', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Yingzhi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kahl', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Ritland', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Rodolphe J', 'Initials': 'RJ', 'LastName': 'Gentili', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Hatfield', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}]",Journal of motor behavior,['10.1080/00222895.2020.1817841']
2928,32943094,Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study.,"BACKGROUND


Many asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation technique are often suboptimal in asthmatic children, but these have traditionally been hard to measure. A novel device functioning as an add-on to the inhaler has been developed to measure both aspects by recording vibration patterns during inhalation. This data can be converted to smart feedback and provided to patients immediately via a mobile application. The aim of this study is to improve asthma control in children between 6 and 18 years old by providing immediate smart feedback on the intake of inhalation medication. Asthma control will be measured by forced expiratory volume in 1 s, (Childhood) Asthma Control Test ((c-)ACT) score, and lung function variability and reversibility.
METHODS


The study will be performed in Medisch Spectrum Twente (Enschede, The Netherlands). The goal is to include 68 uncontrolled moderate to severe asthmatic children between 6 and 18 years old who receive controller inhalation medication through the Nexthaler®, Ellipta®, or Spiromax®. The study consists of three phases. Phase 1 is observational and will last 4 weeks to observe the baseline adherence and inhalation technique as monitored by the add-on device. A randomised controlled trial lasting 6 weeks will be performed in phase 2. Patients in the intervention group will receive immediate smart feedback about the performed inhalations via a mobile application. In the control group, adherence and inhalation technique will be monitored, but patients will not receive feedback. In phase 3, also lasting 6 weeks, the feedback will be ceased for all children and revision of current therapy may occur, depending on the findings in phase 2. Asthma control can be assessed by means of spirometry (both at home and in the hospital) and (c-)ACT questionnaires.
DISCUSSION


Immediate smart feedback may improve therapy adherence and inhalation technique, and thus asthma control in children and prevent unnecessary switches to targeted biologics. Performing this study in children is desired, since they are known to react differently to feedback and medication than adults.
TRIAL REGISTRATION


Dutch Trial Register NL7705 . Registered on 29 April 2019.",2020,"DISCUSSION


Immediate smart feedback may improve therapy adherence and inhalation technique, and thus asthma control in children and prevent unnecessary switches to targeted biologics.","['68 uncontrolled moderate to severe asthmatic children between 6 and 18\u2009years old who receive controller inhalation medication through the Nexthaler®, Ellipta®, or Spiromax®', 'asthmatic children suffer from uncontrolled asthma with frequent exacerbations', 'children with uncontrolled asthma', 'children between 6 and 18\u2009years old by providing immediate smart feedback on the intake of inhalation medication', 'asthmatic children']",['immediate smart feedback'],"['Asthma Control Test ((c-)ACT) score, and lung function variability and reversibility']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}]",,0.0334578,"DISCUSSION


Immediate smart feedback may improve therapy adherence and inhalation technique, and thus asthma control in children and prevent unnecessary switches to targeted biologics.","[{'ForeName': 'Esther T', 'Initials': 'ET', 'LastName': 'Sportel', 'Affiliation': 'Department of Clinical Pharmacy, Medisch Spectrum Twente, Enschede, The Netherlands. e.sportel@mst.nl.'}, {'ForeName': 'Martijn J', 'Initials': 'MJ', 'LastName': 'Oude Wolcherink', 'Affiliation': 'Department of Paediatrics, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Lenferink', 'Affiliation': 'Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Boony J', 'Initials': 'BJ', 'LastName': 'Thio', 'Affiliation': 'Department of Paediatrics, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Kris L L', 'Initials': 'KLL', 'LastName': 'Movig', 'Affiliation': 'Department of Clinical Pharmacy, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Marjolein G J', 'Initials': 'MGJ', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Department of Epidemiology, Medisch Spectrum Twente, Enschede, The Netherlands.'}]",Trials,['10.1186/s13063-020-04694-4']
2929,32943098,Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial.,"OBJECTIVES


To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).
METHODS


Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up.
RESULTS


Thirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0-2] after 6 months; p < 0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.
CONCLUSION


Tocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02101333 . Registered on 02 April 2014.",2020,"A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0-2] after 6 months; p < 0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)].","['Thirteen patients with TAK were included, with a median age of 32\u2009years [19-45] and 12 (92%) females', 'treatment-naive patients with Takayasu arteritis (TAK', 'naïve patients with TAK who received', 'treatment-naïve patients with Takayasu arteritis']","['tocilizumab', 'steroids', 'Tocilizumab']","['disease activity', 'ITAS-A score', 'ITAS-2010 score', 'number of patients who discontinued steroids', 'median NIH scale', 'disease activity and the number of relapses during 18-month follow-up']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039263', 'cui_str': ""Takayasu's disease""}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",13.0,0.0541555,"A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0-2] after 6 months; p < 0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)].","[{'ForeName': 'Arsene', 'Initials': 'A', 'LastName': 'Mekinian', 'Affiliation': 'Sorbonne Universités AP-HP, Hôpital Saint Antoine, service de médecine interne et Inflammation-Immunopathology-Biotherapy Department (DMU 3iD), Faculté de Médecine Sorbonne Université, F-75012, Paris, France. arsene.mekinian@aphp.fr.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saadoun', 'Affiliation': 'Sorbonne Universités AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Département de Médecine Interne et Immunologie Clinique, National center for Autoimmune Systemic rare disease ; National center for Autoinflammatory diseases and amyloidosis, Inflammation-Immunopathology-Biotherapy Department (DMU 3iD), INSERM, UMR_S 959, F-75013, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unité de Recherche Clinique Saint-Louis-Lariboisière, APHP, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Thietart', 'Affiliation': 'Sorbonne Universités AP-HP, Hôpital Saint Antoine, service de médecine interne et Inflammation-Immunopathology-Biotherapy Department (DMU 3iD), Faculté de Médecine Sorbonne Université, F-75012, Paris, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lioger', 'Affiliation': 'Service de Médecine Interne, CHU Tours, Tours, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jego', 'Affiliation': 'Service de Médecine Interne, CHU Rennes, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bleibtreu', 'Affiliation': 'AP-HP, service de médecine interne, Hôpital Jean Verdier, Faculté de Paris 13, 93000, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Limal', 'Affiliation': 'AP-HP, service de médecine interne, Hôpital Mondor, Université Paris Est-Créteil (UPEC), Paris, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Connault', 'Affiliation': 'Service de Médecine Interne, CHU Nantes, Nantes, France.'}, {'ForeName': 'Jacques-Eric', 'Initials': 'JE', 'LastName': 'Gottenberg', 'Affiliation': 'Inserm UMR_1109, Fédération de Médecine Translationnelle, Université de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lhorte', 'Affiliation': 'Service de Médecine Interne et vasculaire, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Jean Pierre', 'Initials': 'JP', 'LastName': 'Bertola', 'Affiliation': 'Medical Department, Chugai Pharma France, Paris La Défense, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Delforge', 'Affiliation': 'AP-HP, service de médecine interne, Hôpital Jean Verdier, Faculté de Paris 13, 93000, Paris, France.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ferreira-Maldent', 'Affiliation': 'Service de Médecine Interne, CHU Tours, Tours, France.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Perlat', 'Affiliation': 'Service de Médecine Interne, CHU Rennes, Rennes, France.'}, {'ForeName': 'Zohra', 'Initials': 'Z', 'LastName': 'Talib', 'Affiliation': 'Unité de Recherche Clinique Saint-Louis-Lariboisière, APHP, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Vautier', 'Affiliation': 'Sorbonne Universités AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Département de Médecine Interne et Immunologie Clinique, National center for Autoimmune Systemic rare disease ; National center for Autoinflammatory diseases and amyloidosis, Inflammation-Immunopathology-Biotherapy Department (DMU 3iD), INSERM, UMR_S 959, F-75013, Paris, France.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Savey', 'Affiliation': 'Sorbonne Universités AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Département de Médecine Interne et Immunologie Clinique, National center for Autoimmune Systemic rare disease ; National center for Autoinflammatory diseases and amyloidosis, Inflammation-Immunopathology-Biotherapy Department (DMU 3iD), INSERM, UMR_S 959, F-75013, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Quiere', 'Affiliation': 'Service de rhumatologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Cacoub', 'Affiliation': 'Sorbonne Universités AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Département de Médecine Interne et Immunologie Clinique, National center for Autoimmune Systemic rare disease ; National center for Autoinflammatory diseases and amyloidosis, Inflammation-Immunopathology-Biotherapy Department (DMU 3iD), INSERM, UMR_S 959, F-75013, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fain', 'Affiliation': 'Sorbonne Universités AP-HP, Hôpital Saint Antoine, service de médecine interne et Inflammation-Immunopathology-Biotherapy Department (DMU 3iD), Faculté de Médecine Sorbonne Université, F-75012, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis research & therapy,['10.1186/s13075-020-02311-y']
2930,32943115,Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark.,"OBJECTIVES


The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic.
HYPOTHESIS


BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months.
TRIAL DESIGN


Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study.
PARTICIPANTS


The trial will recruit 1,500 HCW at Danish hospitals.To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week.A potential subject who meets any of the following criteria will be excluded from participation in this study: Known allergy to components of the BCG vaccine or serious adverse events to prior BCG administration Known prior active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species Previous confirmed COVID-19 Fever (>38 C) within the past 24 hours Suspicion of active viral or bacterial infection Pregnancy Breastfeeding Vaccination with other live attenuated vaccine within the last 4 weeks Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator: Participants will be randomised to BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline). An adult dose of 0.1 ml of resuspended BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control) is administered intradermally in the upper deltoid area of the right arm. All participants will receive one injection at inclusion, and no further treatment of study participants will take place.
MAIN OUTCOMES


Main study endpoint: Days of unplanned absenteeism due to illness within 180 days of randomisation.Secondary study endpoints: The cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission for any reason within 180 days of randomisation.Randomisation: Randomisation will be done centrally using the REDCap tool with stratification by hospital, sex and age groups (+/- 45 years of age) in random blocks of 4 and 6. The allocation ratio is 1:1.Blinding (masking): Participants will be blinded to treatment. The participant will be asked to leave the room while the allocated treatment is prepared. Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.The physicians administering the treatment are not blinded.Numbers to be randomised (sample size): Sample size: N=1,500. The 1,500 participants will be randomised 1:1 to BCG or placebo with 750 participants in each group.Trial Status: Current protocol version 5.1, from July 6, 2020.Recruitment of study participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020.
TRIAL REGISTRATION


The trial was registered with EudraCT on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020, registration number NCT04373291.Full protocol: The full protocol is attached as an additional file, accessible from the Trialswebsite (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.","['1,500 participants', 'participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020', 'on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020', 'health care workers (HCW', '45 years of age) in random blocks of 4 and 6', 'criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week', 'subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with', '1,500 HCW at Danish hospitals', 'recruiting study participants at several geographic locations']","['Pregnancy Breastfeeding Vaccination with other live attenuated vaccine', 'oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator', 'BCG vaccine', 'BCG vaccination', 'BCG or placebo', 'BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control', 'vaccine and placebo', 'Placebo', 'BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline', 'EudraCT']","['absenteeism', 'unplanned absenteeism due to illness', 'cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission']","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031228', 'cui_str': 'Hospital Personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0440790', 'cui_str': 'Solid organ'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0398686', 'cui_str': 'Primary immune deficiency disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199974', 'cui_str': 'Cytokine therapy'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0563322', 'cui_str': 'Intravenous steroid injection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",1500.0,0.519545,"Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.","[{'ForeName': 'Anne Marie Rosendahl', 'Initials': 'AMR', 'LastName': 'Madsen', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark. arosendahl@health.sdu.dk.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Schaltz-Buchholzer', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research & Disruption of Infectious Diseases (CREDID), Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bjerregaard-Andersen', 'Affiliation': 'Department of Medicine, Sydvestjysk Hospital, Esbjerg, Denmark.'}, {'ForeName': 'Lars Skov', 'Initials': 'LS', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Medicine, Herning Hospital, Herning, Denmark.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dam', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Sisse Bolm', 'Initials': 'SB', 'LastName': 'Ditlev', 'Affiliation': 'The Copenhagen Center for Translational Research (CCTR), Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gulia', 'Initials': 'G', 'LastName': 'Faizi', 'Affiliation': 'Department of Medicine, Sydvestjysk Hospital, Esbjerg, Denmark.'}, {'ForeName': 'Isik Somuncu', 'Initials': 'IS', 'LastName': 'Johansen', 'Affiliation': 'Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Poul-Erik', 'Initials': 'PE', 'LastName': 'Kofoed', 'Affiliation': 'Department of Pediatrics, Lillebaelt Hospital, Kolding, Denmark.'}, {'ForeName': 'Gitte Schultz', 'Initials': 'GS', 'LastName': 'Kristensen', 'Affiliation': 'Department of Medicine, Soenderjylland Hospital, Aabenraa, Denmark.'}, {'ForeName': 'Ellen Christine Leth', 'Initials': 'ECL', 'LastName': 'Loekkegaard', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hilleroed, Denmark.'}, {'ForeName': 'Christian Backer', 'Initials': 'CB', 'LastName': 'Mogensen', 'Affiliation': 'Department of Medicine, Soenderjylland Hospital, Aabenraa, Denmark.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Mohamed', 'Affiliation': 'Department of Pediatrics, Lillebaelt Hospital, Kolding, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ostenfeld', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hilleroed, Denmark.'}, {'ForeName': 'Emilie Sundhaugen', 'Initials': 'ES', 'LastName': 'Oedegaard', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Marcus Kjaer', 'Initials': 'MK', 'LastName': 'Soerensen', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wejse', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital, Skejby, Denmark.'}, {'ForeName': 'Aksel Karl Georg', 'Initials': 'AKG', 'LastName': 'Jensen', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Tyra Grove', 'Initials': 'TG', 'LastName': 'Krause', 'Affiliation': 'Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}]",Trials,['10.1186/s13063-020-04714-3']
2931,32943128,Increasing dietary fibre intake in healthy adults using personalised dietary advice compared with general advice: a single-blind randomised controlled trial.,"OBJECTIVE


A high-fibre diet is associated with a lower risk for diseases. However, few adults meet the dietary fibre recommendation. Therefore, the effects and acceptance of an algorithm-generated personalised dietary advice (PDA) compared with general advice (GA) on fibre intake were investigated.
DESIGN


A 6-week, single-blind randomised controlled trial with a 3-month follow-up.
SETTING


PDA was based on habitual intake and provided fibre-rich alternatives using a website; GA contained brochures. Dietary intake was assessed at baseline, week 1, week 6 and 3-month follow-up. Both groups evaluated their advice at week 6. All participants had access to PDA from week 7 until 3-month follow-up.
PARTICIPANTS


Two groups of healthy adults: PDA (n 34) and GA (n 47). For 3-month follow-up analysis, participants were re-divided into visitors (n 52) and non-visitors (n 26) of the PDA.
RESULTS


At week 6, energy intake remained stable in both groups, but fibre intake per 1000 kcal increased non-significantly in both groups (PDA = Δ0·5 ± 2·8; GA = Δ0·8 ± 3·1, P = 0·128). Importantly, a significantly higher percentage of PDA participants adhered to the recommendation compared with week 1 (PDA = 21 % increase; GA = 4 % increase, P ≤ 0·001). PDA participants evaluated the advice significantly better compared with GA participants. At 3-month follow-up, fibre intake increased compared with baseline (visitors = Δ2·2 ± 2·6, P < 0·001; non-visitors = Δ1·5 ± 1·9, P = 0·001), but was insignificantly different between groups. Visitors had a decrease and non-visitors had an increase in energy intake (visitors =Δ - 132 ± 525; non-visitors = Δ109 ± 507, P = 0·055).
CONCLUSIONS


The algorithm-generated PDA was well accepted and stimulated adherence to the recommendations more than GA, indicating to be a suitable and cost-efficient method for improving dietary fibre intake in healthy adults.",2020,"At week 6, energy intake remained stable in both groups, but fibre intake per 1000 kcal increased non-significantly in both groups (PDA = Δ0·5 ± 2·8; GA = Δ0·8 ± 3·1, P = 0·128).","['participants were re-divided into visitors (n 52) and non-visitors (n 26) of the PDA', 'Two groups of healthy adults: PDA (n 34) and GA (n 47', 'healthy adults']","['personalised dietary advice', 'algorithm-generated personalised dietary advice (PDA', 'PDA', 'general advice (GA']","['fibre intake', 'Dietary intake', 'fibre intake per 1000 kcal increased non', 'energy intake']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0631735,"At week 6, energy intake remained stable in both groups, but fibre intake per 1000 kcal increased non-significantly in both groups (PDA = Δ0·5 ± 2·8; GA = Δ0·8 ± 3·1, P = 0·128).","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Rijnaarts', 'Affiliation': 'Division of Human Nutrition & Health, Wageningen University & Research, Stippeneng 4, 6708 WE Wageningen, the Netherlands.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'de Roos', 'Affiliation': 'Division of Human Nutrition & Health, Wageningen University & Research, Stippeneng 4, 6708 WE Wageningen, the Netherlands.'}, {'ForeName': 'Taojun', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Laboratory of Microbiology, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Erwin G', 'Initials': 'EG', 'LastName': 'Zoetendal', 'Affiliation': 'Laboratory of Microbiology, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Top', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Timmer', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Bouwman', 'Affiliation': 'Wageningen Economic Research, Wageningen University & Research, Wageningen, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Hogenelst', 'Affiliation': 'Department of Training and Performance Innovations, The Netherlands Organization for Applied Scientific Research (TNO), Soesterberg, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Witteman', 'Affiliation': 'Division of Human Nutrition & Health, Wageningen University & Research, Stippeneng 4, 6708 WE Wageningen, the Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'de Wit', 'Affiliation': 'Wageningen Food and Biobased Research, Wageningen University & Research, Wageningen, the Netherlands.'}]",Public health nutrition,['10.1017/S1368980020002980']
2932,32943404,Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial.,"BACKGROUND


There are no determined treatment agents for the severe coronavirus disease 2019 (COVID-19); therefore, it is suggested that methylprednisolone, as an immunosuppressive treatment, can reduce the inflammation of the respiratory system.
METHODS


We conducted a single-blind, randomised, controlled, clinical trial involving severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran. The patients were randomly allocated in a 1:1 ratio by block randomisation method to receive standard care with methylprednisolone pulse (intravenous injection, 250 mg·day -1  for 3 days) or standard care alone. The study endpoint was the time of clinical improvement or death, whichever came first. Primary and safety analysis was done in the intention-to-treat (ITT) population.
RESULTS


Sixty-eight eligible patients underwent randomisation (34 patients in each group) from April 20, till Jun 20, 2020. In the standard care group, six patients received corticosteroids by the attending physician during treatment and excluded from the ITT population. Patients with clinical improvement were higher in the methylprednisolone group than in the standard care group (94·1%  versus  57·1%), and the mortality rate was numerically lower in the methylprednisolone group (5·9%  versus  42.9%; p <0·001). We demonstrated that patients in the methylprednisolone intervention group had a significantly increased survival time compared with the patients in the standard care group [Log rank test: p<0.001; Hazard ratio: 0.293; 95% C‎‎I: 0.‎154-0.556]. A total of two patients in each group (5·8% and 7·1% respectively) showed severe adverse events between initiation of treatment and the end of the study.
CONCLUSIONS


Our results suggested that methylprednisolone pulse could be an efficient therapeutic agent for hospitalised severe COVID-19 patients at the pulmonary phase.",2020,"Patients with clinical improvement were higher in the methylprednisolone group than in the standard care group (94·1%  versus  57·1%), and the mortality rate was numerically lower in the methylprednisolone group (5·9%  versus  42.9%; p <0·001).","['Sixty-eight eligible patients underwent randomisation (34 patients in each group) from April 20, till Jun 20, 2020', 'severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran', 'hospitalised severe COVID-19 patients', 'hospitalised severe COVID-19 patients at the pulmonary phase']","['corticosteroids', 'methylprednisolone pulse', 'methylprednisolone intervention', 'methylprednisolone', 'Intravenous methylprednisolone pulse', 'standard care with methylprednisolone pulse (intravenous injection, 250\u2005mg·day -1  for 3\u2005days) or standard care alone']","['time of clinical improvement or death, whichever came first', 'severe adverse events', 'survival time', 'mortality rate']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0162508', 'cui_str': 'jun Oncogene'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021494', 'cui_str': 'Intravenous injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",68.0,0.165073,"Patients with clinical improvement were higher in the methylprednisolone group than in the standard care group (94·1%  versus  57·1%), and the mortality rate was numerically lower in the methylprednisolone group (5·9%  versus  42.9%; p <0·001).","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Edalatifard', 'Affiliation': 'Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Akhtari', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious and Tropical Medicines, Tehran University \u200eof Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Naderi', 'Affiliation': 'Department of Pulmonology, Isfahan University of Medical Sciences, \u200eIsfahan, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Jamshidi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Mostafaei', 'Affiliation': 'Department of Biostatistics, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Najafizadeh', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Farhadi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Jalili', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Zanjan University of Medical Sciences, Zanjan, \u200eIran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Esfahani', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Besharat', 'Initials': 'B', 'LastName': 'Rahimi', 'Affiliation': 'Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kazemzadeh', 'Affiliation': 'Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Mahmoodi Aliabadi', 'Affiliation': 'Department of Laboratory, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Ghazanfari', 'Affiliation': 'Immunoregulation Research Centre, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Satarian', 'Affiliation': 'Simorgh Clinical Laboratory, Tehran, Iran.'}, {'ForeName': 'Hourvash', 'Initials': 'H', 'LastName': 'Ebrahimi Louyeh', 'Affiliation': 'Departement of rheumatology, Imam khomeini hospital complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Raeeskarami', 'Affiliation': 'Department of Pediatrics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeidreza', 'Initials': 'S', 'LastName': 'Jamali Moghadam Siahkali', 'Affiliation': 'Department of Infectious and Tropical Medicines, Tehran University \u200eof Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Khajavirad', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdorahman', 'Initials': 'A', 'LastName': 'Rostamian', 'Affiliation': 'Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",The European respiratory journal,['10.1183/13993003.02808-2020']
2933,32943459,Amphiregulin expression is a predictive biomarker for EGFR inhibition in metastatic colorectal cancer: combined analysis of three randomized trials.,"BACKGROUND


Amphiregulin ( AREG ) and epiregulin ( EREG ) are ligands of the epidermal growth factor receptor ( EGFR ). Predictive information for anti- EGFR  treatment in metastatic colorectal cancer (mCRC) was observed, but data for other agents is limited.
METHODS


Ligand mRNA expression,  RAS ,  BRAF,   PIK3CA  mutations and  EGFR  expression were assessed by RTqPCR, pyrosequencing and immunohistochemistry, respectively, in mCRC tumor tissue of patients participating in the randomized controlled trials FIRE-1, CIOX and FIRE-3. Normalized mRNA expression was dichotomized using median and 3rd quartile. Overall (OS) and progression-free survival (PFS) were estimated by Kaplan-Meier method including univariate and multivariate Cox regression analyses. Penalised spline regression analysis tested interaction of mRNA expression and outcome.
RESULTS


Of 688 patients with available material, high  AREG  expression was detected in 343 (> median) and 172 (> 3 rd  quartile) patients, respectively. High  AREG  expression was associated with significantly higher OS (26.2 vs. 21.5 months, HR 0.80 [95% CI 0.68 - 0.94],  p  = 0.007), PFS (10.0 vs. 8.1 months, HR 0.74 [95% CI 0.63 - 0.86],  p  = 0.001) and ORR (63.1 % vs. 51.6 %,  p  = 0.004) compared to low expression at both threshold values. This effect remained significant in multivariate Cox regression analysis (OS:  p  = 0.01, PFS:  p  = 0.002). High  AREG  mRNA expression interacted significantly with the efficacy of cetuximab compared to bevacizumab (OS:  p  = 0.02, PFS:  p  = 0.04) in  RAS  WT mCRC.
CONCLUSIONS


High  AREG  mRNA expression is a favorable prognostic biomarker for mCRC which interacted significantly with efficacy of anti- EGFR  treatment.",2020,"High  AREG  expression was associated with significantly higher OS (26.2 vs. 21.5 months, HR 0.80","['metastatic colorectal cancer (mCRC', 'metastatic colorectal cancer', '688 patients with available material']","['bevacizumab', 'cetuximab']","['ORR', 'Overall (OS) and progression-free survival (PFS', 'PFS', 'Normalized mRNA expression']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",688.0,0.0798149,"High  AREG  expression was associated with significantly higher OS (26.2 vs. 21.5 months, HR 0.80","[{'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Stahler', 'Affiliation': 'Department of Medicine III, University of Munich arndt.stahler@med.uni-muenchen.de.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Department of Medicine III, University Hospital Munich, LMU Munich.'}, {'ForeName': 'Dominik Paul', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Hematology, Oncology and tumorimmunology, Medical Department, Division of Hematology, Oncology and Tumor Immunology (CVK), Charité Universitaetsmedizin Berlin.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ricard', 'Affiliation': 'Institute of Medical Informatics, Biometry and Epidemiology, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Giessen-Jung', 'Affiliation': 'Department of Medicine III, University of Munich.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kapaun', 'Affiliation': 'Institute of Pathology, University of Munich.'}, {'ForeName': 'Boryana', 'Initials': 'B', 'LastName': 'Ivanova', 'Affiliation': 'Institute of Pathology, University of Munich.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Oncology, VK&K Studien GbR.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Praxis für Onkologie/Haematologie, Gesundheitszentrum St. Marien GmbH.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Moosmann', 'Affiliation': 'Krankenhaus Barmherzige Brüder.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schalhorn', 'Affiliation': 'Department of Internal Medicine III, Ludwig-Maximilians-University - Großhadern.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Stauch', 'Affiliation': 'Onkologische Praxis Kronach.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kiani', 'Affiliation': 'Department of Medicine IV, Klinikum Bayreuth GmbH.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess (Germany).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Onkologie Ravensburg.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'I. Dept. Med., University of Mainz.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Neumann', 'Affiliation': 'Institute of Pathology, University of Munich.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kirchner', 'Affiliation': 'Institute of Pathology, University of Munich.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'Institut of Pathology, University of Munich.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2748']
2934,32943657,A randomized controlled trial of cystoinflation to prevent bladder injury in the adhesive disease of multiple caesarean sections.,"Caesarean sections carry the risk of urinary bladder injury due to formation of adhesions obscuring pelvic planes. Visualizing bladder during retro-fill (cystoinflation) makes it recognizable as it rises into the abdomen taking a tense rounded contour. We conducted a prospective randomized controlled trial to find out whether improved identification of bladder margins by cystoinflation could decrease bladder injury rate and blood loss without causing urological complications. This study included 214 healthy women with previous operative deliveries undergoing elective caesarean section and found to have dense pelvic adhesions. The subjects were randomly allocated into cystoinflation and control groups. Adhesiolysis was performed using bladder retro-fill with 300 cc saline in cystoinflation group, and without retro-fill in control. The bladder injury rate was significantly lower in cystoinflation group compared to control (2.8% vs 20.6%, P < .0001) with lesser blood loss in cystoinflation group (585.33 cc vs 797.10 cc, P < .0001). Mean operative time was similar in both groups. Urinary tract infection and micturition problems occurred more frequently in control group than cystoinflation group (16.8% vs 1.9%, P = .001 and .47 ± 1.63% vs 077 ± .633%, P = .021 respectively) with fistula in one subject compared to none in cystoinflation group. In this study, cystoinflation was effective to significantly reduce bladder injury rate and blood loss. This technique may also prove useful in the fields of surgery, urology and urogynecology.",2020,"The bladder injury rate was significantly lower in cystoinflation group compared to control (2.8% vs 20.6%, P < .0001) with lesser blood loss in cystoinflation group (585.33 cc vs 797.10 cc, P < .0001).","['adhesive disease of multiple caesarean sections', '214 healthy women with previous operative deliveries undergoing elective caesarean section and found to have dense pelvic adhesions']",[],"['Urinary tract infection and micturition problems', 'bladder injury rate and blood loss', 'Mean operative time', 'blood loss', 'bladder injury rate']","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3495929', 'cui_str': 'Multiple caesarean sections'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0262591', 'cui_str': 'Pelvic adhesions'}]",[],"[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0241705', 'cui_str': 'Difficulty passing urine'}, {'cui': 'C0403677', 'cui_str': 'Injury of bladder'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",214.0,0.0773345,"The bladder injury rate was significantly lower in cystoinflation group compared to control (2.8% vs 20.6%, P < .0001) with lesser blood loss in cystoinflation group (585.33 cc vs 797.10 cc, P < .0001).","[{'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Saaqib', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan. shaziasaaqib@gmail.com.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan.'}, {'ForeName': 'Munazza', 'Initials': 'M', 'LastName': 'Naheed', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan.'}, {'ForeName': 'Tayyaba', 'Initials': 'T', 'LastName': 'Saeed', 'Affiliation': 'King Edward Medical University/Lady Willingdon Hospital, Lahore, Pakistan.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Khalid', 'Affiliation': 'Institute of Public Health, Lahore, Pakistan.'}]",Scientific reports,['10.1038/s41598-020-71132-5']
2935,32943750,Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study.,"We previously reported the benefit of lomustine addition to conventional chemotherapy in older acute myeloid leukemias with nonadverse chromosomal aberrations in the LAM-SA 2007 randomized clinical trial (NCT00590837). A molecular analysis of 52 genes performed in 330 patients included in this trial, 163 patients being treated with lomustine in combination with idarubicin and cytarabine and 167 without lomustine, identified 1088 mutations with an average of 3.3 mutations per patient. NPM1, FLT3, and DNMT3A were the most frequently mutated genes. A putative therapeutic target was identified in 178 patients (54%). Among five molecular classifications analyzed, the ELN2017 risk classification has the stronger association with the clinical evolution. Patients not treated with lomustine have an expected survival prognosis in agreement with this classification regarding the overall and event-free survivals. In strong contrast, lomustine erased the ELN2017 classification prognosis. The benefit of lomustine in nonadverse chromosomal aberrations was restricted to patients with RUNX1, ASXL1, TP53, and FLT3-ITD high /NPM1 WT  mutations in contrast to the intermediate and favorable ELN2017 patients. This post-hoc analysis identified a subgroup of fit elderly AML patients with intermediate cytogenetics and molecular markers who may benefit from lomustine addition to intensive chemotherapy.",2020,Patients not treated with lomustine have an expected survival prognosis in agreement with this classification regarding the overall and event-free survivals.,"['and 167 without lomustine, identified 1088 mutations with an average of 3.3 mutations per patient', 'older acute myeloid leukemias with nonadverse chromosomal aberrations', '178 patients (54', '52 genes performed in 330 patients included in this trial, 163 patients being treated with', 'elderly AML patients with intermediate cytogenetics and molecular markers who may benefit from lomustine addition to intensive chemotherapy']","['Lomustine', 'conventional chemotherapy', 'lomustine in combination with idarubicin and cytarabine', 'lomustine']",['survival prognosis'],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",163.0,0.0386189,Patients not treated with lomustine have an expected survival prognosis in agreement with this classification regarding the overall and event-free survivals.,"[{'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Largeaud', 'Affiliation': 'Hematology Biology, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopôle, Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Cornillet-Lefebvre', 'Affiliation': 'Hematology Biology, Reims University Hospital, Reims, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Hamel', 'Affiliation': 'Department of Statistics, Angers University Hospital, Angers, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Dumas', 'Affiliation': 'Clinical Hematology, Bordeaux University Hospital, Bordeaux University, Inserm 1035, Bordeaux, France.'}, {'ForeName': 'Naïs', 'Initials': 'N', 'LastName': 'Prade', 'Affiliation': 'Hematology Biology, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopôle, Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Dufrechou', 'Affiliation': 'Hematology Biology, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopôle, Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Plenecassagnes', 'Affiliation': 'Bioinformatic Department, Claudius Regaud Institute, Institut Universitaire du Cancer de Toulouse Oncopôle, Toulouse, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Luquet', 'Affiliation': 'Hematology Biology, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopôle, Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Blanchet', 'Affiliation': 'Hematology Biology, Angers University Hospital, Angers University, Inserm, CRCINA, Angers, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Banos', 'Affiliation': 'Clinical Hematology, Cote Basque General Hospital, Bayonne, France.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Béné', 'Affiliation': 'Hematology Biology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bernard', 'Affiliation': 'Clinical Hematology, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bertoli', 'Affiliation': 'Clinical Hematology, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopôle, Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bonmati', 'Affiliation': 'Clinical Hematology, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Luc Matthieu', 'Initials': 'LM', 'LastName': 'Fornecker', 'Affiliation': 'Clinical Hematology, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Guièze', 'Affiliation': 'Clinical Hematology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Lamya', 'Initials': 'L', 'LastName': 'Haddaoui', 'Affiliation': 'FILO Tumor Bank, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Hunault', 'Affiliation': 'Clinical Hematology, Angers University Hospital, INSERM U 892/CNRS 6299, Angers, France.'}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Ianotto', 'Affiliation': 'Clinical Hematology, Institute of Oncology and Hematology, Brest University Hospital, Brest, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jourdan', 'Affiliation': 'Clinical Hematology, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ojeda', 'Affiliation': 'Clinical Hematology, GHRMSA, Hôpital E Muller, Mulhouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Peterlin', 'Affiliation': 'Clinical Hematology, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Vey', 'Affiliation': 'Clinical Hematology, Aix-Marseille University, Inserm, CNRS, Institut Paoli-Calmettes, CRCM, Marseille, France.'}, {'ForeName': 'Hacene', 'Initials': 'H', 'LastName': 'Zerazhi', 'Affiliation': 'Clinical Hematology, Avignon General Hospital, Avignon, France.'}, {'ForeName': 'Hicheri', 'Initials': 'H', 'LastName': 'Yosr', 'Affiliation': 'Clinical Hematology, Aix-Marseille University, Inserm, CNRS, Institut Paoli-Calmettes, CRCM, Marseille, France.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Mineur', 'Affiliation': 'Clinical Research Unit, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Cahn', 'Affiliation': 'Clinical Hematology, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Ifrah', 'Affiliation': 'Clinical Hematology, Angers University Hospital, INSERM U 892/CNRS 6299, Angers, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Récher', 'Affiliation': 'Clinical Hematology, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopôle, Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Pigneux', 'Affiliation': 'Clinical Hematology, Bordeaux University Hospital, Bordeaux University, Inserm 1035, Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Delabesse', 'Affiliation': 'Hematology Biology, Centre Hospitalier Universitaire de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopôle, Université Toulouse III Paul Sabatier, Toulouse, France. delabesse.eric@iuct-oncopole.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-01031-1']
2936,32943911,"Effects of Additional Intraoperative Administration of Sufentanil on Postoperative Pain, Stress and Inflammatory Responses in Patients Undergoing Laparoscopic Myomectomy: A Double-Blind, Randomized, Placebo-Controlled Trial.","Purpose


Although pain after laparoscopic surgery is assumed to be minor, many women still suffer from unexpected postoperative pain. Thus, we aimed to assess whether additional intraoperative administration of sufentanil could help to improve postoperative pain and related agitation, stress, and inflammation response in patients undergoing laparoscopic myomectomy.
Patients and Methods


Forty female patients with uterine myoma scheduled for laparoscopic myomectomy under general anesthesia were randomized to receive sufentanil (group T, n=20) or normal saline (group C, n=20) 1h before the end of the surgery. The postoperative pain, agitation, stress, inflammation, and adverse effects were measured.
Results


As the primary outcome, the visual analog scale (VAS) pain score was significantly reduced in group T as compared with group C at each measured time point in a post-anesthesia care unit (PACU), VAS 5 min (31.5 ± 2.7 vs 40.6 ± 5.6) ( P <0.001), VAS 30 min (36.5 ± 4.5 vs 46.0 ± 2.9) ( P <0.001), VAS 1h (37.8 ± 4.0 vs 48.6 ± 5.5) ( P <0.001). The secondary outcomes, including the sedation agitation scale (SAS) scores, plasma concentrations of epinephrine and norepinephrine, and the levels of plasma interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-alpha (TNF-α) in group T were remarkably lower than those in group C ( P  < 0.001). The cough cases in group T also showed a significant reduction in comparison with group C ( P  < 0.05). In addition, the anesthetic recovery time, including the spontaneous breathing recovery time and extubation time, were not significantly different between the two groups, as were the cases of respiratory depression and postoperative delirium ( P  > 0.05).
Conclusion


For patients undergoing laparoscopic myomectomy, administration of sufentanil 1 h before the end of surgery shows excellent analgesic and sedative effects, alleviated postoperative stress and inflammatory responses, reduced incidence of cough, without prolonging anesthetic recovery time and increasing adverse reactions.",2020,The cough cases in group T also showed a significant reduction in comparison with group C ( P  < 0.05).,"['patients undergoing', 'patients undergoing laparoscopic myomectomy', 'Patients Undergoing Laparoscopic Myomectomy', 'Patients and Methods\n\n\nForty female patients with uterine myoma scheduled for laparoscopic myomectomy under general anesthesia']","['laparoscopic myomectomy', 'sufentanil', 'normal saline', 'Placebo', 'Sufentanil']","['Postoperative Pain, Stress and Inflammatory Responses', 'postoperative pain and related agitation, stress, and inflammation response', 'analgesic and sedative effects, alleviated postoperative stress and inflammatory responses, reduced incidence of cough, without prolonging anesthetic recovery time and increasing adverse reactions', 'visual analog scale (VAS) pain score', 'postoperative pain, agitation, stress, inflammation, and adverse effects', 'anesthetic recovery time', 'sedation agitation scale (SAS) scores, plasma concentrations of epinephrine and norepinephrine, and the levels of plasma interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-alpha (TNF-α', 'spontaneous breathing recovery time and extubation time', 'respiratory depression and postoperative delirium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",40.0,0.699028,The cough cases in group T also showed a significant reduction in comparison with group C ( P  < 0.05).,"[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.""}, {'ForeName': 'Bingyu', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Cao', 'Affiliation': ""Department of Ultrasound Imaging, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.""}, {'ForeName': 'Wenwei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Academic Research, Renmin Hospital of Wuhan University, Wuhan, Hubei 430060, People's Republic of China.""}, {'ForeName': 'Shihua', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, Renmin Hospital of Hannan District, Wuhan, Hubei 430090, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S257337']
2937,32943914,Are Cognitive Load and Focus of Attention Differentially Involved in Pain Management: An Experimental Study Using a Cold Pressor Test and Virtual Reality.,"Objective


The aim of this study is to assess whether distraction (lack of attentional focus) and attention (cognitive load) are differentially involved in the analgesic effect of virtual reality (VR) immersions during a cold pressor test (CPT).
Methods


Thirty-one participants were randomly assigned to four experimental conditions (high and low cognitive load, attention with or without a reminder of the pain stimuli) and performed three CPTs. Pain was assessed based on the duration of the CPT (pain tolerance), a visual analog rating scale of perceived pain intensity during the CPT and the subjective pain scale of the Short form McGill Pain Questionnaire (SF-MPQ).
Results


The statistical analyses revealed that VR immersions were associated with less pain compared to the baseline (all p <0.001), but for the experimental manipulations, only the conditions where there was an increase in cognitive load (ie, from low cognitive load at Immersion 1 to high cognitive load at Immersion 2) were effective for increasing pain tolerance (significant Time X Conditions interaction). The interactions were not significant for pain intensity assessed with the VAS or the SF-MPQ.
Conclusion


The results suggest that increases in cognitive load play an important role in the analgesic effect of VR immersion, although the combination of attentional focus and cognitive load may be important. Suggestions are given for designing a replication study.",2020,"The statistical analyses revealed that VR immersions were associated with less pain compared to the baseline (all p <0.001), but for the experimental manipulations, only the conditions where there was an increase in cognitive load (ie, from low cognitive load at Immersion 1 to high cognitive load at Immersion 2) were effective for increasing pain tolerance (significant Time X Conditions interaction).",['Methods\n\n\nThirty-one participants'],"['experimental conditions (high and low cognitive load, attention with or without a reminder of the pain stimuli) and performed three CPTs']","['cognitive load', 'pain tolerance', 'pain intensity', 'Pain', 'duration of the CPT (pain tolerance), a visual analog rating scale of perceived pain intensity during the CPT and the subjective pain scale of the Short form McGill Pain Questionnaire (SF-MPQ', 'pain']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}]",31.0,0.0259048,"The statistical analyses revealed that VR immersions were associated with less pain compared to the baseline (all p <0.001), but for the experimental manipulations, only the conditions where there was an increase in cognitive load (ie, from low cognitive load at Immersion 1 to high cognitive load at Immersion 2) were effective for increasing pain tolerance (significant Time X Conditions interaction).","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Dumoulin', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Claudie', 'Initials': 'C', 'LastName': 'Loranger', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Quintana', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Gougeon', 'Affiliation': 'Department of Psychology, Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Lavoie', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montréal, QC, Canada.'}]",Journal of pain research,['10.2147/JPR.S238766']
2938,32944084,The prophylactic effects of BIFICO on the antibiotic-induced gut dysbiosis and gut microbiota.,"Background


The aim of this study is to evaluate the prophylactic effects of probiotic mixture BIFICO on antibiotic-induced gut dysbiosis (AIGD) and the influence on the change of the gut microbiota.
Methods


We conducted a prospective, randomized, controlled study and divided 196 patients who required intravenous beta-lactam antibiotics into three groups: a control group (no probiotics), a regular group (840 mg of BIFICO), and a double-dosage group (1680 mg of BIFICO). The symptoms of antibiotic-related diarrhea, bloating and abdominal pain and the incidence of AIGD were evaluated 7 days and 8-14 days after antibiotic use, with 10 patients in each group. 16S rDNA sequencing was performed to detect changes of the gut microbiota.
Results


Within 7 days of the initiation of antibiotic treatment, the incidences of AIGD in the control group, regular group (840 mg of BIFICO), and double-dosage group (1680 mg of BIFICO) were 21.88%, 14.93%, and 6.15% respectively. On days of 8-14th, the incidences of AIGD in the control group, regular group, and double-dosage group were 25%, 14.93%, and 4.62%, respectively. The incidence of AIGD in the double-dosage group within 7 days and 14 days were both significantly lower than that in relevant control group (P < 0.05). On day 14, the incidence of AIGD in the double-dosage group was lower than that in the regular group (P < 0.05). The number of operational taxonomic units (OTUs) in the control group after antibiotic treatment was significantly reduced compared to that prior to treatment, while those of the regular and double-dosage groups were stable. The species abundance, especially  Parabacteroides, Phascolarctobacterium  and  Roseburia , of the double-dosage group was greater than that of the regular group and the control group.
Conclusions


BIFICO may reduce the occurrence of AIGD in a dose-dependent manner and can stabilize the gut microbiota balance.",2020,"The number of operational taxonomic units (OTUs) in the control group after antibiotic treatment was significantly reduced compared to that prior to treatment, while those of the regular and double-dosage groups were stable.",['divided 196 patients who required intravenous beta-lactam antibiotics into three groups: a'],"['control group (no probiotics), a regular group (840\xa0mg of BIFICO', 'probiotic mixture BIFICO']","['incidences of AIGD', 'incidence of AIGD', 'number of operational taxonomic units (OTUs', 'symptoms of antibiotic-related diarrhea, bloating and abdominal pain and the incidence of AIGD', 'antibiotic-induced gut dysbiosis and gut microbiota']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026458', 'cui_str': 'Monobactam'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.0308677,"The number of operational taxonomic units (OTUs) in the control group after antibiotic treatment was significantly reduced compared to that prior to treatment, while those of the regular and double-dosage groups were stable.","[{'ForeName': 'Jiannong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Critical Care, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Tieer', 'Initials': 'T', 'LastName': 'Gan', 'Affiliation': 'Department of Infection Management, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Center of Clinical Evaluation, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Guolian', 'Initials': 'G', 'LastName': 'Xia', 'Affiliation': 'Department of Critical Care, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Department of Pneumology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Bingxin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Pneumology, Fuyang District People's Hospital of Hangzhou, Hangzhou, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, 54 Youdian RoadZhejiang Province, Hangzhou, 310009 China.'}]",Gut pathogens,['10.1186/s13099-020-00379-0']
2939,32944093,"Correction to: Effectiveness of a resistance training program on physical function, muscle strength, and body composition in community-dwelling older adults receiving home care: a cluster-randomized controlled trial.",[This corrects the article DOI: 10.1186/s11556-020-00243-9.].,2020,[This corrects the article DOI: 10.1186/s11556-020-00243-9.].,['community-dwelling older adults receiving home care'],['resistance training program'],"['physical function, muscle strength, and body composition']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",,0.0247859,[This corrects the article DOI: 10.1186/s11556-020-00243-9.].,"[{'ForeName': 'Hilde Bremseth', 'Initials': 'HB', 'LastName': 'Bårdstu', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}, {'ForeName': 'Marius Steiro', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Aasdahl', 'Affiliation': 'Unicare Helsefort Rehabilitation Centre, Rissa, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Kristoffer T', 'Initials': 'KT', 'LastName': 'Cumming', 'Affiliation': 'Department of Sports, Physical Education and Outdoor Studies, Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Vestfold, Norway.'}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Sæterbakken', 'Affiliation': 'Department of Sport, Food and Natural Sciences, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, PB 133, 6851 Sogndal, Norway.'}]",European review of aging and physical activity : official journal of the European Group for Research into Elderly and Physical Activity,['10.1186/s11556-020-00245-7']
2940,32944201,"Evaluating the effect on asthma quality of life of added reflexology or homeopathy to conventional asthma management - an investigator-blinded, randomised, controlled parallel group study.","Background


Asthma is a common chronic disease worldwide without any known cure. Despite remarkable improvement in asthma treatment, better education and guideline implementation strategies, there is growing interest in using complementary and alternative medicine, like reflexology and homeopathy. However, evidence supporting the effectiveness of homeopathy and reflexology in asthma treatment is not available.
Objective


The aim of this study was to evaluate the effect of reflexology and homeopathy as adjunctive therapies in asthma.
Methods


In a single centre, randomised, investigator blinded, controlled study 86 asthma patients were enrolled. They were assigned to one of three study groups (conventional treatment alone or conventional treatment with addition of either homeopathy or reflexology). All patients received their asthma treatment during the study and were followed as usual by their general practitioner. The study assignment group of individual patients were blinded to the investigators, who made the clinical evaluation of asthma control. The primary outcome was the change in the asthma quality of life questionnaire (AQLQ) scores after 26 weeks. Secondary outcomes included asthma control questionnaire, EuroQol, forced expiratory volume in 1 sec, morning and evening peak expiratory flow, asthma symptoms, rescue medication use, and total medication score.
Results


Minor improvements in the AQLQ score were observed in all three groups. However, no statistically significant changes in AQLQ scores were seen within or between groups. Likewise, secondary outcomes did not differ between groups.
Conclusions


In this study, the addition of homeopathy or reflexology to conventional treatment did not result in improved quality of life in asthma.",2020,"In this study, the addition of homeopathy or reflexology to conventional treatment did not result in improved quality of life in asthma.","['asthma', '86 asthma patients were enrolled']","['conventional treatment alone or conventional treatment with addition of either homeopathy or reflexology', 'added reflexology or homeopathy', 'reflexology and homeopathy']","['AQLQ score', 'quality of life in asthma', 'asthma control questionnaire, EuroQol, forced expiratory volume in 1 sec, morning and evening peak expiratory flow, asthma symptoms, rescue medication use, and total medication score', 'change in the asthma quality of life questionnaire (AQLQ) scores', 'AQLQ scores']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0684199', 'cui_str': 'Homeopathic therapy'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",86.0,0.161566,"In this study, the addition of homeopathy or reflexology to conventional treatment did not result in improved quality of life in asthma.","[{'ForeName': 'Ayfer', 'Initials': 'A', 'LastName': 'Topcu', 'Affiliation': 'Department of Medicine, The Regional Hospital in Horsens, Horsens, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Løkke', 'Affiliation': 'Department of Medicine, Little Belt Hospital, Vejle, Denmark.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Eriksen', 'Affiliation': 'CAM Consultant, Reflexologist, Copenhagen, Denmark.'}, {'ForeName': 'Lars Peter', 'Initials': 'LP', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Dahl', 'Affiliation': 'Global Medical Expert, GSK, Copenhagen, Denmark.'}]",European clinical respiratory journal,['10.1080/20018525.2020.1793526']
2941,32944251,The combined effect of parathyroid hormone (1-34) and whole-body vibration exercise on physical performance in OSteoporotic women (PaVOS study): a secondary analysis from a randomised controlled trial.,"Background


The aim of this study was to investigate the effect on physical performance of combining whole-body vibration exercise (WBV) with parathyroid hormone 1-34 (teriparatide) compared to teriparatide alone.
Methods


A secondary analysis from a RCT where postmenopausal women with severe osteoporosis were randomised to WBV plus teriparatide (intervention) or teriparatide alone (control). WBV was applied three times/week (6x1min WBV:1 min rest, (peak acceleration 3.6  g )) for twelve months. Both groups received teriparatide 20 μg s.c./day. The primary endpoint (bone mineral density) is reported elsewhere. Physical performance measures (Short Physical Performance Battery (SPPB), Timed-Up-and-Go (TUG), leg extension power, and grip strength) were obtained at baseline, three-, six-, and twelve months, lean mass at baseline and twelve months. Data were analysed with mixed linear regression model or robust cluster regression in an intention to treat analysis.
Results


Thirty-five women aged (mean ± SD) 69 ± 7) years were recruited of which thirty-two (91%) completed the twelve months follow-up (WBV + teriparatide = 15, teriparatide = 17). SPPB score (mean ± SD) improved significantly at three months in the WBV + teriparatide group from 9.13 ± 2.03 to 10.35 ± 1.69 ( p  = 0.014) with a statistical trend towards a between-group change in favor of the WBV + teriparatide group (0.86 [95%CI(- 0.05,1.77),  p  = 0.065]). Both groups improved in leg extension power during the study period whereas no changes were seen in TUG, grip strength, or lean mass in either group. No statistical significant between-group differences were observed.
Conclusion


WBV may improve some short-term aspects of physical performance in severely osteoporotic postmenopausal women who are receiving teriparatide treatment.
Trial Registration


ClinicalTrials.gov, ID:NCT02563353.",2020,"Both groups improved in leg extension power during the study period whereas no changes were seen in TUG, grip strength, or lean mass in either group.","['OSteoporotic women (PaVOS study', 'postmenopausal women with severe osteoporosis', 'severely osteoporotic postmenopausal women who are receiving teriparatide treatment', 'Thirty-five women aged (mean\u2009±\u2009SD) 69\u2009±\u20097) years were recruited of which thirty-two (91%) completed the twelve months follow-up (WBV\u2009+\u2009teriparatide\u2009=\u200915, teriparatide\u2009=\u200917']","['teriparatide alone', 'parathyroid hormone (1-34) and whole-body vibration exercise', 'combining whole-body vibration exercise (WBV) with parathyroid hormone 1-34 (teriparatide', 'teriparatide 20\u2009μg\u2009s.c./day', 'WBV plus teriparatide (intervention) or teriparatide alone (control']","['leg extension power', 'primary endpoint (bone mineral density', 'physical performance', 'TUG, grip strength, or lean mass', 'SPPB score (mean\u2009±\u2009SD', 'Physical performance measures (Short Physical Performance Battery (SPPB), Timed-Up-and-Go (TUG), leg extension power, and grip strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C1956225', 'cui_str': 'PTH(1-34)'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}]",35.0,0.144653,"Both groups improved in leg extension power during the study period whereas no changes were seen in TUG, grip strength, or lean mass in either group.","[{'ForeName': 'Ditte Beck', 'Initials': 'DB', 'LastName': 'Jepsen', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Masud', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Holsgaard-Larsen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Stinus', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'Department of Endocrinology, Hospital South West Jutland, Esbjerg, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Ryg', 'Affiliation': 'Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00204-w']
2942,32938481,Examining fidelity in the INFORM trial: a complex team-based behavioral intervention.,"BACKGROUND


Fidelity in complex behavioral interventions is underexplored. This study examines the fidelity of the INFORM trial and explores the relationship between fidelity, study arm, and the trial's primary outcome-care aide involvement in formal team communications about resident care.
METHODS


A concurrent process evaluation of implementation fidelity was conducted in 33 nursing homes in Western Canada (Alberta and British Columbia). Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced-Assisted Feedback arms of the INFORM trial.
RESULTS


Fidelity of the INFORM intervention was moderate to high, with fidelity delivery and receipt higher than fidelity enactment for both study arms. Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) = 4.27, p = .042).
CONCLUSIONS


Overall fidelity enactment was associated with improvements in formal team communications, but the study arm was not. This suggests that the intensity with which an intervention is offered and delivered may be less important than the intensity with which intervention participants enact the core components of an intervention. Greater attention to fidelity assessment and publication of fidelity results through studies such as this one is critical to improving the utility of published trials.",2020,"Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) =","['Study participants were from 106 clinical care units clustered in 33 nursing homes randomized to the Basic and Enhanced-Assisted Feedback arms of the INFORM trial', '33 nursing homes in Western Canada (Alberta and British Columbia']",[],['formal team communications'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}]",[],"[{'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.113839,"Higher enactment teams experienced a significantly larger improvement in formal team communications between baseline and follow-up than lower enactment teams (F(1, 70) =","[{'ForeName': 'Liane R', 'Initials': 'LR', 'LastName': 'Ginsburg', 'Affiliation': 'School of Health Policy & Management, Faculty of Health, York University, Toronto, Ontario, M3J 1P3, Canada. lgins@yorku.ca.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hoben', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Easterbrook', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Thompson Rivers University, Kamloops, British Columbia, V2C 0C8, Canada.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'School of Nursing, University of North Carolina, Chapel Hill, North Carolina, 27599-7460, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cranley', 'Affiliation': 'Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, M5T 1P8, Canada.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Lanham', 'Affiliation': 'University of Texas Health Science Center San Antonio, University of Texas, San Antonio, Texas, 78229, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Norton', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, T2N 4\u2009N1, Canada.'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Weeks', 'Affiliation': 'School of Nursing, Faculty of Health, Dalhousie University, Halifax, Nova Scotia, B3H 4R2, Canada.'}, {'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Estabrooks', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, Canada.'}]",Implementation science : IS,['10.1186/s13012-020-01039-2']
2943,32938496,Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release. Elevated levels of blood IL-6 had been identified as a one of the risk factors associated with severe COVID-19 disease. Anti-IL6 inhibitors are among the therapeutic armamentarium for preventing the fatal consequences of acute respiratory and multi organ failure in around 20% of the COVID-19 infected patients. At present, their use is prioritized to patients with severe interstitial pneumonia (Brescia-COVID Scale-COVID 2-3) with hyperinflammation as determined by the presence of elevated IL6 and/or d-dimer, or progressive d-dimer increase, in patients who otherwise are subsidiary to ICU admission. However, many uncertainties remain on the actual role of anti-IL6 inhibitors in this setting, and whether current use and timing is the right one. There is the hypothesis that the use of anti-IL6 inhibitors at an earlier state during the hyperinflammatory syndrome would be beneficial and may avoid progressing to ARDS. On the other hand, the standard of care has changed and nowadays the use of corticosteroids has become part of the SOC in the treatment of COVID-19 pneumonia. Our limited experience suggests that better treatment outcomes can be achieved when combining IL6-inhibitors (e.g. sarilumab) with corticosteroids. The aim of the present study is to evaluate if an earlier therapeutic intervention with sarilumab plus SOC (including corticosteroids) may be more effective than current standard of care alone, in preventing progression to respiratory failure in COVID-19 infected patients with interstitial pneumonia. This study will also provide supportive evidence to that provided by currently ongoing studies on the efficacy and safety of sarilumab in this clinical context.
TRIAL DESIGN


A phase two multi-center randomised controlled trial (RCT) with two parallel arms (1:1 ratio).
PARTICIPANTS


They will be hospitalized patients, of at least 18 years of age, with severe COVID-19 who have positive RT-PCR test and have radiographic evidence of pulmonary infiltrates by imaging or rales/crackles on exam and SpO2 ≤ 94% on room air that requires supplemental oxygen. Patients must present elevation of inflammatory parameters (IL-6 > 40 pg/mL or d-dimer >1.0 mcg/ml) or, alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 24-48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer.
EXCLUSION CRITERIA


high oxygen requirements (including face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula, or mechanical ventilation), admission to ICU, pregnancy or lactation, allergy or hypersensitivity to sarilumab or corticoesteroids, immunosuppressive antibody therapy within the past 5 months, AST/ALT values > 10 x ULN, neutropenia (< 0.5 x 109/L), severe thrombocytopenia (< 50 x 109/L), sepsis caused by an alternative pathogen, diverticulitis with risk of perforation or ongoing infectious dermatitis. The study will be conducted in several hospitals in Spain.
INTERVENTION AND COMPARATOR


Patients randomised to the experimental arm will receive sarilumab + methylprednisolone plus SOC for COVID-19. Patients included in the control arm will receive methylprednisolone plus SOC for COVID-19. Corticosteroids will be given to all patients at a 1mg/kg/d of methylprednisolone for at least 3 days. Clinical follow-up visits will be performed at 3, 5, and 15 days after treatment randomization. Patients in the control group (SOC group without sarilumab) progressing to Brescia- COVID 2-3 plus inflammatory markers, will be given the option to be rescued with sarilumab at the same doses and, in that case, be included in an open-label phase and be followed up for additional weeks (with visits at 3, 7 and 15 days after sarilumab rescue administration). Patients randomly assigned to sarilumab therapy at baseline progressing to Brescia-COVID 2-3 will be rescued according to local clinical practice protocols. A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
MAIN OUTCOMES


Primary end point is the proportion of patients progressing to either severe respiratory failure (Brescia-COVID ≥2), ICU admission, or death.
RANDOMIZATION


Randomization codes were produced by means of the PROC PLAN of the SAS system, with a 1:1 assignment ratio, stratifying by centre and using blocks multiple of 2 elements. The randomization schedule will be managed through the eCRF in a concealed manner.
BLINDING (MASKING)


All study drugs will be administered as open label. No blinding methods will be used in this trial.
NUMBERS TO BE RANDOMISED (SIMPLE SIZE)


The target sample size will be 200 COVID-19 patients, who will be allocated randomly to control arm (100) and treatment arm (100).
TRIAL STATUS


Protocol Code: SARTRE Protocol Date: May 05th 2020. Version: 2.0 The study has been approved by the Spanish Competent Authority (AEMPS) as a low intervention clinical trial. Start of recruitment: August, 2020 End of recruitment: May, 2021 TRIAL REGISTRATION: Identifier: EudraCT Number: 2020-002037-15 ; Registration date: 26 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
","['Identifier: EudraCT Number: 2020-002037-15 ; Registration date: 26 May 2020', 'hospitalized patients', ' 50 x 109/L), sepsis caused by an alternative pathogen, diverticulitis with risk of perforation or ongoing infectious dermatitis', 'They will be hospitalized patients, of at least 18 years of age, with severe COVID-19 who have positive RT-PCR test and have radiographic evidence of pulmonary infiltrates by imaging or rales/crackles on exam and SpO2 ≤ 94% on room air that requires supplemental oxygen', '200 COVID-19 patients', 'several hospitals in Spain', 'COVID-19 infected patients with interstitial pneumonia', '2020 End of recruitment']","['sarilumab plus SOC (including corticosteroids', 'sarilumab therapy', 'methylprednisolone', 'Sarilumab versus standard of care', 'sarilumab + methylprednisolone plus SOC for COVID-19', 'Corticosteroids', 'methylprednisolone plus SOC']","['severe thrombocytopenia', 'admission to ICU, pregnancy or lactation, allergy or hypersensitivity to sarilumab or corticoesteroids, immunosuppressive antibody therapy', 'Elevated levels of blood IL-6', 'proportion of patients progressing to either severe respiratory failure (Brescia-COVID ≥2), ICU admission, or death']","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0034642', 'cui_str': 'Respiratory crackles'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",200.0,0.169355,"A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
","[{'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Caballero Bermejo', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Ruiz-Antorán', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain. mariabelen.ruiz@salud.madrid.org.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández Cruz', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Diago Sempere', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Callejas Díaz', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Múñez Rubio', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Avendaño-Solá', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ramos Martínez', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Aránzazu', 'Initials': 'A', 'LastName': 'Sancho López', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04633-3']
2944,32938555,"Reply to Letter to the Editor ""Outcomes of open ""crown"" type v. percutaneous Bunnell type repair of acute Achilles tendon ruptures. Randomized control study"".",,2020,,['acute Achilles tendon ruptures'],"['open ""crown"" type v. percutaneous Bunnell type repair']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.0548507,,"[{'ForeName': 'Aleksas', 'Initials': 'A', 'LastName': 'Makulavicius', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania. Electronic address: makulaviciusa@gmail.com.'}, {'ForeName': 'Giedrius', 'Initials': 'G', 'LastName': 'Mazarevicius', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Klinga', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Matas', 'Initials': 'M', 'LastName': 'Urmanavicius', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Povilas', 'Initials': 'P', 'LastName': 'Masionis', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Valentinas', 'Initials': 'V', 'LastName': 'Uvarovas', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Narunas', 'Initials': 'N', 'LastName': 'Porvaneckas', 'Affiliation': 'Vilnius University, Faculty of Medicine, Clinic of Rheumatology, Orthopaedic - Traumatology and Reconstructive Surgery, Centre of Orthopedics and Traumatology, Republican Vilnius University Hospital, Šiltnamiu g. 29, LT-04130 Vilnius, Lithuania.'}, {'ForeName': 'Xavier Martin', 'Initials': 'XM', 'LastName': 'Oliva', 'Affiliation': 'Barcelona University, Faculty of Medicine, Department of Embriology and Human Anatomy, Barcelona, Spain.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.09.002']
2945,32938569,Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma.,"Tivozanib is a potent and selective inhibitor of the VEGF receptor. In an open-label, randomized phase 3 trial, we compared tivozanib to sorafenib in patients with metastatic renal cell carcinoma (mRCC) who had received two or three prior therapies. We have previously reported that the study met its primary endpoint, demonstrating an improvement in progression-free survival with tivozanib versus sorafenib (5.6 mo vs 3.9 mo; hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.56-0.94; p=0.016). The current report reflects the final assessment of overall survival, showing no difference between treatment with tivozanib and sorafenib (HR 0.97, 95% CI 0.75-1.24). Given its activity and distinct tolerability profile, tivozanib represents a treatment option for patients with previously treated mRCC. PATIENT SUMMARY: We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments. No difference in survival was observed.",2020,"We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments.","['Subjects with Metastatic Renal Cell Carcinoma', 'patients with kidney cancer who have received two or three prior treatments', 'patients with previously treated mRCC', 'patients with metastatic renal cell carcinoma (mRCC) who had received two or three prior therapies']","['Tivozanib to Sorafenib', 'tivozanib versus sorafenib', 'tivozanib', 'tivozanib and sorafenib', 'Tivozanib', 'tivozanib to sorafenib', 'targeted therapy (sorafenib']","['progression-free survival', 'survival', 'overall survival']","[{'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2827667', 'cui_str': 'tivozanib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.141364,"We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments.","[{'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Escudier', 'Affiliation': 'Department of Oncology Medicine, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Department of Medical Oncology, Georgetown Lombardi University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Urologic Oncology, Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia Chief, Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verzoni', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Needle', 'Affiliation': 'AVEO Oncology, Boston, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Powers', 'Affiliation': 'AVEO Oncology, Boston, MA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA. Electronic address: brian.rini@vumc.org.'}]",European urology,['10.1016/j.eururo.2020.08.007']
2946,32938620,Palbociclib and trastuzumab in HER2-positive advanced breast cancer: Results from the phase II SOLTI-1303 PATRICIA trial.,"PURPOSE


To assess palbociclib in combination with trastuzumab with or without endocrine therapy in patients with HER2-positive advanced breast cancer.
PATIENTS AND METHODS


PATRICIA is a prospective, open-label, multicenter phase II trial. Patients had received 2-4 prior lines of anti-HER2-based regimens. Treatment consisted of palbociclib 200 mg daily for 2 weeks and 1 week off plus trastuzumab. The study was based on a Simon 2-stage design comprising 3 cohorts: estrogen receptor (ER)-negative (cohort A), ER-positive (cohort B1) and ER-positive with letrozole (cohort B2). ER-positive patients were randomized to cohorts B1 or B2. Primary endpoint was progression-free survival rate at 6 months (PFS6). Secondary objectives included safety and evaluation of the PAM50 intrinsic subtypes.
RESULTS


71 patients were recruited (n=15 in cohort A and 28 in each cohort B). The PFS6 rate in cohorts A, B1 and B2 was 33.3% (5/15), 42.8% (12/28) and 46.4% (13/28), respectively. Regarding safety, grade 1-2 and 3-4 toxicities occurred in 97.7% and 84.4% of patients, respectively. The most common grade 3-4 toxicities were neutropenia (66.4%) and thrombocytopenia (11.3%). Regarding PAM50, 59 (83.1%) tumors were profiled. Luminal disease defined by PAM50 was found independently associated with longer PFS compared to non-luminal disease (10.6 vs. 4.2 months median PFS; adjusted hazard ratio=0.40; p-value=0.003).
CONCLUSION


Palbociclib in combination with trastuzumab is safe and exhibits promising survival outcomes in trastuzumab pre-treated ER-positive/HER2-positive advanced breast cancer with a PAM50 luminal A or B subtype. The enrollment was stopped prematurely and a new randomized cohort was opened in this population.",2020,"The PFS6 rate in cohorts A, B1 and B2 was 33.3% (5/15), 42.8% (12/28) and 46.4% (13/28), respectively.","['HER2-positive advanced breast cancer', '71 patients were recruited (n=15 in cohort A and 28 in each cohort B', 'patients with HER2-positive advanced breast cancer', 'ER-positive patients']","['trastuzumab with or without endocrine therapy', 'trastuzumab', 'Palbociclib and trastuzumab', 'palbociclib 200 mg daily for 2 weeks and 1 week off plus trastuzumab', 'estrogen receptor (ER)-negative (cohort A), ER-positive (cohort B1) and ER-positive with letrozole']","['safety and evaluation of the PAM50 intrinsic subtypes', 'progression-free survival rate', 'thrombocytopenia', 'PFS6 rate', 'neutropenia', 'toxicities']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",71.0,0.127422,"The PFS6 rate in cohorts A, B1 and B2 was 33.3% (5/15), 42.8% (12/28) and 46.4% (13/28), respectively.","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'Medical Oncology Department, Hospital 12 de Octubre eva.ciruelos@gmail.com.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Villagrasa', 'Affiliation': 'SOLTI breast cancer research group.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Department of Medical Oncology, Hospital Clinic de Barcelona.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO).""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': 'Medical oncology, Catalan Institute of Oncology, IDIBELL.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI breast cancer research group.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Escrivá-de-Romaní', 'Affiliation': ""Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital, Medical Oncology Department.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Medical Oncology, Hospital Universitario 12 De Octubre.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'Medical Oncology, Hospital Clinic.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martínez de Dueñas', 'Affiliation': 'Department of Medical Oncology, 1 Hospital Provincial de Castellón, Castellón, Spain. 2 GEICAM Spanish Breast Cancer Group.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'Medical Oncology, International Breast Cancer Centre, Quiron Group.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Vázquez', 'Affiliation': ""Institut Català d'Oncologia, Hospitalet del Llobregat, Spain.""}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Perelló', 'Affiliation': 'Hospital Universitario Son Espases.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Garau', 'Affiliation': 'Hospital Son Llàtzer, Palma de Mallorca, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Melé', 'Affiliation': 'Hospital Universitari Sant Joan de Reus, Reus, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Martínez Jañez', 'Affiliation': 'Oncología Médica, Hospital Universitario Gregorio Marañón.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Montaño', 'Affiliation': 'Hospital universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Department of Oncology and Hematology. Breast Cancer Unit. Research Institute INCLIVA., Hospital Clinico Universitario.'}, {'ForeName': 'Serafín', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'Medical Oncology Department, Hospital Universitàri Arnau de Vilanova.'}, {'ForeName': 'Mª Jose', 'Initials': 'MJ', 'LastName': 'Echarri', 'Affiliation': 'Hospital Universitario Severo Ochoa, Madrid, Spain.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Vega', 'Affiliation': 'Oncology, Centro Integral Oncológico Clara Campal (CIOCC).'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'González-Farré', 'Affiliation': 'Department of Pathology, Hospital Clinic de Barcelona.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': ""Translational Genomics, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Medical Oncology, Hospital Clinic.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Canes', 'Affiliation': 'Scientific department, SOLTI breast cancer research group.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Molecular Oncology, Vall d'Hebron Institute of Oncology (VHIO).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gonzàlez Farré', 'Affiliation': 'Institut Oncològic Dr. Rosell, Hospital General de Catalunya, Institut Oncològic Dr. Rosell.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Department of Medical Oncology, Hospital Clinic de Barcelona.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0844']
2947,32938869,Reducing bacterial counts around the abutment following professional mechanical plaque removal at the implant bridge: A randomized crossover comparison of removing or not removing the superstructure.,"PURPOSE


The purpose of this study was to determine whether removing the superstructure of the implant bridge in cases of full-arch implant restorations for edentulous atrophic arches at the abutment level during professional mechanical plaque removal (PMPR) affects bacterial counts.
METHODS


This crossover clinical trial included 20 patients who received screw-retained prostheses at the abutment level. Patients were randomly assigned to two groups and received PMPR with or without removal of the superstructure. After a three-month washout period, the type of treatment was reversed between the groups. Bacterial counts around the cylinder and abutment were measured and compared before and after PMPR.
RESULTS


Bacterial numbers around the cylinder and abutment were significantly reduced after PMPR as compared with before PMPR regardless of whether the superstructure was removed (p <0.05). However the ratio of subjects with bacteria at 1.0 × 105 colony forming unit/ml (cfu/ml) or more after PMPR was significantly higher when the superstructure was not removed (p < 0.05). Among patients with bacterial counts of less than 10 × 105 cfu/ml, bacterial loads were reduced to less than 1.0 × 105 cfu/ml even when superstructures were not removed. Among patients with bacterial load of >10 × 105 cfu/ml, bacterial numbers were not reduced to <1.0 × 105 cfu/ml when PMPR was performed without removing the superstructure.
CONCLUSIONS


Removal of the superstructure in cases of full-arch implant restorations for edentulous atrophic arches during PMPR reduces bacterial numbers around the implant bridge at the abutment level.",2020,"RESULTS


Bacterial numbers around the cylinder and abutment were significantly reduced after PMPR as compared with before PMPR regardless of whether the superstructure was removed (p <0.05).","['cases of full-arch implant restorations for edentulous atrophic arches at the abutment level during professional mechanical plaque removal (PMPR', '20 patients who received screw-retained prostheses at the abutment level']","['PMPR with or without removal of the superstructure', 'removing or not removing the superstructure']","['bacterial loads', 'Bacterial counts']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",20.0,0.0358116,"RESULTS


Bacterial numbers around the cylinder and abutment were significantly reduced after PMPR as compared with before PMPR regardless of whether the superstructure was removed (p <0.05).","[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Oral Implant and Temporomandibular Joint Clinic, Niigata University Medical and Dental Hospital, Niigata.'}, {'ForeName': 'Mutsumi', 'Initials': 'M', 'LastName': 'Inanobe-Takatsuka', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Toyama University Hospital, Toyama.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Takashima', 'Affiliation': 'Oral Implant and Temporomandibular Joint Clinic, Niigata University Medical and Dental Hospital, Niigata.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Ogawa', 'Affiliation': 'Oral Implant and Temporomandibular Joint Clinic, Niigata University Medical and Dental Hospital, Niigata.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Oral Implant and Temporomandibular Joint Clinic, Niigata University Medical and Dental Hospital, Niigata.'}, {'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Nohno', 'Affiliation': 'Division of Preventive Dentistry, Niigata University Graduate School of Medical and Dental Sciences, Niigata.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Uoshima', 'Affiliation': 'Oral Implant and Temporomandibular Joint Clinic, Niigata University Medical and Dental Hospital, Niigata.'}]",Journal of prosthodontic research,['10.2186/jpr.JPOR_2019_431']
2948,32938875,Accuracy of online symptom checkers for diagnosis of orofacial pain and oral medicine disease.,"PURPOSE


The aim of this study was to compare and contrast the diagnostic accuracy of multiple online symptom checkers when used for the diagnosis of orofacial pain and oral medicine related disease vignettes. The comparison condition used in this study was the diagnostic accuracy achieved by advanced specialty residents on these same vignettes using a virtual patient system.
METHODS


27 individual disease vignettes were utilized. These vignettes had a variety of orofacial pain and oral medicine diseases. Post graduate orofacial pain and oral medicine residents at our University of Southern California interacted with their randomly assigned virtual patients were analyzed [n=574]. Virtual patient accuracy was based on whether the user selected the primary diagnosis as one of their top four choices after interviewing. Eleven English-language symptom checkers accuracy was based on whether the vignettes produced the primary diagnosis as one of their top four choices. Using these data, symptom checker and virtual patient accuracy rates were calculated.
RESULTS


The primary diagnosis on virtual patient encounters was found within the top four choices a mean of 67.2% of the time. The primary diagnosis for the same vignettes entered into the 11 symptom checkers was found within the top four choices a mean of 5.9% of the time.
CONCLUSIONS


The accuracy of currently available symptom checkers that patient might use for self-diagnosis of common orofacial pain and oral medicine diseases was low, this result suggest that the improved diagnostic algorithms are needed.",2020,Virtual patient accuracy was based on whether the user selected the primary diagnosis as one of their top four choices after interviewing.,"['diagnosis of orofacial pain and oral medicine disease', 'Post graduate orofacial pain and oral medicine residents at our University of Southern California interacted with their randomly assigned virtual patients were analyzed [n=574', '27 individual disease vignettes were utilized']",[],"['virtual patient encounters', 'symptom checker and virtual patient accuracy rates', 'diagnostic accuracy']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",11.0,0.0349442,Virtual patient accuracy was based on whether the user selected the primary diagnosis as one of their top four choices after interviewing.,"[{'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, Showa University, Tokyo.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Thomas Clark', 'Affiliation': 'Orofacial Pain and Oral Medicine Center and Distance Learning Office, Herman Ostrow School of Dentistry, University of Southern California,Los Angeles.'}]",Journal of prosthodontic research,['10.2186/jpr.JPOR_2019_499']
2949,32938903,Treatment of at-level spinal cord injury pain with botulinum toxin A.,"STUDY DESIGN


Randomized, double-blinded, placebo-controlled, cross-over study.
OBJECTIVE


To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
SETTING


Outpatient SCI clinic, New York, USA.
METHODS


Participants were randomized to receive subcutaneous injections of either placebo or BoNTA with follow-up (office visit, telephone, or e-mail) at 2, 4, 8, and 12 weeks to assess the magnitude of pain relief post injection. Crossover of participants was then performed. Those who received placebo received BoNTA, and vice versa, with follow-up at 2, 4, 8, and 12 weeks.
RESULTS


Eight participants completed at least one of the two crossover study arms. Four completed both arms. The median age of the eight participants was 45 years (range 32-61 years) and 75% were male. All had traumatic, T1-L3 level, complete SCI. Although our data did not meet statistical significance, we noted a higher proportion of participants reporting a marked change in average pain intensity from baseline to 8 and 12 weeks post-BoNTA vs. post-placebo (33% vs. 0%). At 2 and 4 weeks post-BoNTA, almost all participants reported some degree of reduced pain, while the same was not seen post-placebo (83% vs. 0%).
CONCLUSION


The subcutaneous injection of BoNTA may be a feasible approach for the control of at-level SCI pain and is worthy of further study.
SPONSORSHIP


The onabotulinumtoxinA (BOTOX) used in this study was provided by Allergan (Irvine, CA).",2019,"To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
",['The median age of the eight participants was 45 years (range 32-61 years) and 75% were male'],"['botulinum toxin A (BoNTA', 'placebo', 'botulinum toxin A']","['traumatic, T1-L3 level, complete SCI', 'degree of reduced pain', 'average pain intensity']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0446434', 'cui_str': 'Level of the third lumbar vertebra'}, {'cui': 'C3544168', 'cui_str': 'Complete spinal cord injury'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",8.0,0.484571,"To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA. audrey.s.chun@mssm.edu.'}, {'ForeName': 'Isaiah', 'Initials': 'I', 'LastName': 'Levy', 'Affiliation': 'Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}, {'ForeName': 'Ajax', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'The Spine and Pain Institute of New York, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Tsai', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leung', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Department of Pain Medicine, Northwell Health Physician Partners, Bay Shore, NY, USA.'}, {'ForeName': 'Kristell', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kolakowsky-Hayner', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Escalon', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Bryce', 'Affiliation': 'Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0221-9']
2950,32938935,Time-restricted feeding alters lipid and amino acid metabolite rhythmicity without perturbing clock gene expression.,"Time-restricted feeding (TRF) improves metabolism independent of dietary macronutrient composition or energy restriction. To elucidate mechanisms underpinning the effects of short-term TRF, we investigated skeletal muscle and serum metabolic and transcriptomic profiles from 11 men with overweight/obesity after TRF (8 h day -1 ) and extended feeding (EXF, 15 h day -1 ) in a randomised cross-over design (trial registration: ACTRN12617000165381). Here we show that muscle core clock gene expression was similar after both interventions. TRF increases the amplitude of oscillating muscle transcripts, but not muscle or serum metabolites. In muscle, TRF induces rhythmicity of several amino acid transporter genes and metabolites. In serum, lipids are the largest class of periodic metabolites, while the majority of phase-shifted metabolites are amino acid related. In conclusion, short-term TRF in overweight men affects the rhythmicity of serum and muscle metabolites and regulates the rhythmicity of genes controlling amino acid transport, without perturbing core clock gene expression.",2020,"TRF increases the amplitude of oscillating muscle transcripts, but not muscle or serum metabolites.","['11 men with overweight/obesity after TRF (8\u2009h day -1 ) and extended feeding (EXF, 15\u2009h day -1 ']","['TRF', 'Time-restricted feeding (TRF']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}]",[],,0.0420832,"TRF increases the amplitude of oscillating muscle transcripts, but not muscle or serum metabolites.","[{'ForeName': 'Leonidas S', 'Initials': 'LS', 'LastName': 'Lundell', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Evelyn B', 'Initials': 'EB', 'LastName': 'Parr', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Fitzroy, VIC, 3000, Australia.'}, {'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Devlin', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Fitzroy, VIC, 3000, Australia.'}, {'ForeName': 'Lars R', 'Initials': 'LR', 'LastName': 'Ingerslev', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Altıntaş', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Center for Epigenetics and Metabolism, INSERM U1233, Department of Biological Chemistry, School of Medicine, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sassone-Corsi', 'Affiliation': 'Center for Epigenetics and Metabolism, INSERM U1233, Department of Biological Chemistry, School of Medicine, University of California, Irvine, Irvine, CA, USA.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Barrès', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juleen R', 'Initials': 'JR', 'LastName': 'Zierath', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Juleen.Zierath@ki.se.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hawley', 'Affiliation': 'Exercise and Nutrition Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Fitzroy, VIC, 3000, Australia. john.hawley@acu.edu.au.'}]",Nature communications,['10.1038/s41467-020-18412-w']
2951,32938990,Modulation of TRPV-1 by prostaglandin-E 2  and bradykinin changes cough sensitivity and autonomic regulation of cardiac rhythm in healthy subjects.,"A neurogenic pathway, involving airway TRPV-1, has been implicated in acute cardiovascular events occurring after peaks of air pollution. We tested whether inhaled prostaglandin-E 2  (PGE 2 ) and bradykinin (BK) regulate TRPV-1 activity in vivo by changing cough response to capsaicin (CPS) and affecting heart rate variability (HRV), while also taking into account the influence of TRPV-1 polymorphisms (SNPs). Moreover, we assessed the molecular mechanism of TRPV-1 modulation in vitro. Seventeen healthy volunteers inhaled 100 μg PGE 2 , 200 μg BK or diluent in a randomized double-blind fashion. Subsequently, the response to CPS was assessed by cough challenge and the sympathetic activity by HRV, expressed by low (nLF) and high (nHF) normalized frequency components, as well as nLF/nHF ratio. Intracellular [Ca 2+ ] was measured in HeLa cells, transfected with wild-type TRPV-1, pre-treated with increasing doses of PGE 2 , BK or diesel exhaust particulate (DEP), after CPS stimulation. Six functional TRPV-1 SNPs were characterized in DNA from each subject. Inhalation of PGE 2  and BK was associated with significant increases in cough response induced by 30 μM of CPS (cough number after PGE 2  = 4.20 ± 0.42; p < 0.001, and after BK = 3.64 ± 0.37; p < 0.01), compared to diluent (2.77 ± 0.29) and in sympathetic activity (nLF/nHF ratio after PGE 2  = 6.1; p < 0.01, and after BK = 4.2; p < 0.05), compared to diluent (2.5-3.3). No influence of SNPs was observed on autonomic regulation and cough sensitivity. Unlike PGE 2  and BK, DEP directly activated TRPV-1. Inhalation of PGE 2  and BK sensitizes TRPV-1 and is associated with autonomic dysregulation of cardiac rhythm in healthy subjects.",2020,Inhalation of PGE 2  and BK sensitizes TRPV-1 and is associated with autonomic dysregulation of cardiac rhythm in healthy subjects.,"['Seventeen healthy volunteers inhaled 100\xa0μg PGE 2 , 200\xa0μg', 'healthy subjects']","['BK or diluent', 'inhaled prostaglandin-E 2  (PGE 2 ) and bradykinin (BK', 'SNPs', 'capsaicin (CPS', 'TRPV-1 by prostaglandin-E 2  and bradykinin']","['cough response', 'heart rate variability (HRV', 'Intracellular ', 'autonomic regulation and cough sensitivity', 'sympathetic activity (nLF/nHF ratio']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0006100', 'cui_str': 'Kallidin I'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",17.0,0.0833612,Inhalation of PGE 2  and BK sensitizes TRPV-1 and is associated with autonomic dysregulation of cardiac rhythm in healthy subjects.,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Liviero', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Scarpa', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'De Stefani', 'Affiliation': 'Department of Biomedical Sciences, University of Padova, Padua, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Folino', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Campisi', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mason', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Sabino', 'Initials': 'S', 'LastName': 'Iliceto', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Pavanello', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy. sofia.pavanello@unipd.it.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Maestrelli', 'Affiliation': 'Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.'}]",Scientific reports,['10.1038/s41598-020-72062-y']
2952,32939456,Efficacy of cavity liners with/without atmospheric cold helium plasma jet for dentin remineralization.,"Aim:  This study aimed to assess the efficacy of cavity liners with/without the atmospheric cold plasma jet (ACPJ) for dentin remineralization.
Material and methods


The occlusal third of 24 extracted third molars was cut. An occlusal cavity was prepared in the dentin of each tooth with 1 mm depth and 2 mm diameter and demineralized with 37% phosphoric acid for 1 min. The teeth were randomly divided into 8 groups ( n  = 3). The first control group only underwent demineralization with phosphoric acid. The second control group underwent demineralization and helium plasma jet. Groups 3 to 5 were filled with calcium hydroxide (CH), RetroMTA (MTA) and Biodentine. Groups 6 to 8 were subjected to ACPJ, and all the groups were sealed with polycarboxylate. After 2 weeks of immersion in water, the teeth were longitudinally sectioned and their mineral content was analyzed using energy-dispersive X-ray spectroscopy (EDX).
Results


The interaction effect of ACPJ and type of liner was not significant ( p  > 0.05). Application of ACPJ in combination with liner had a significant effect on calcium and phosphorous contents ( p  < .05). The calcium and phosphorous contents in the control groups were significantly lower than other groups ( p  < .05). The calcium and phosphorous contents in the CH group were higher than the control but significantly lower than the MTA and Biodentine groups. The values in the MTA and Biodentine groups were the same and higher than other groups.
Conlusion


All three cavity liners significantly increased the calcium and phosphorous contents of dentin. This increase was significantly greater by the MTA and Biodentine and enhanced by the ACPJ.",2020,The calcium and phosphorous contents in the CH group were higher than the control but significantly lower than the MTA and Biodentine groups.,['dentin remineralization'],"['demineralization with phosphoric acid', 'demineralized with 37% phosphoric acid', 'demineralization and helium plasma jet', 'cavity liners with/without the atmospheric cold plasma jet (ACPJ', 'cavity liners with/without atmospheric cold helium plasma jet', 'ACPJ', 'polycarboxylate', 'calcium hydroxide (CH), RetroMTA (MTA) and Biodentine']","['calcium and phosphorous contents of dentin', 'calcium and phosphorous contents']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0018880', 'cui_str': 'Helium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0600199', 'cui_str': 'Dental cavity liner'}, {'cui': 'C2936478', 'cui_str': 'Non-Thermal Atmospheric Pressure Plasma'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C4310582', 'cui_str': 'RetroMTA'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",,0.0180675,The calcium and phosphorous contents in the CH group were higher than the control but significantly lower than the MTA and Biodentine groups.,"[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Kermanshah', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Saeedi', 'Affiliation': 'School of Dentistry, Shahid Sadoughi University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ahmadi', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Ranjbar Omrani', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",Biomaterial investigations in dentistry,['10.1080/26415275.2020.1803074']
2953,32939539,Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR): A Protocol for a Randomized Clinical Trial.,"OBJECTIVE


Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may prevent the posttraumatic osteoarthritis that affects over 50% of knees with ACLR. However, a fundamental gap exists in our understanding of how to maximize muscle strength through rehabilitation. Neurological deficits and muscle atrophy are 2 of the leading mechanisms of muscle weakness after ACLR. High-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise (ECC) have been shown to independently target these mechanisms. If delivered in succession, NMES and then ECC may be able to significantly improve strength recovery. The objectives of this study were to evaluate the ability of NMES combined with ECC to restore quadriceps strength, biomechanical symmetry, and maintain cartilage health at 9 and 18 months after ACLR.
METHODS


This study is a randomized, double-blind, placebo-controlled, single-center clinical trial conducted at the University of Michigan. A total of 112 participants between the ages of 14 and 45 years and with an ACL rupture will be included. Participants will be randomly assigned 1:1 to NMES combined with ECC or NMES placebo combined with ECC placebo. NMES or NMES placebo will be delivered 2 times per week for 8 weeks beginning 10 to 14 days postoperatively and will be directly followed by 8 weeks of ECC or ECC placebo delivered 2 times per week. The co-primary endpoints are change from baseline to 9 months and change from baseline to 18 months after ACLR in isokinetic quadriceps strength symmetry. Secondary outcome measures include isometric quadriceps strength, quadriceps activation, quadriceps muscle morphology (cross-sectional area), knee biomechanics (sagittal plane knee angles and moments), indexes of patient-reported function, and cartilage health (T1ρ and T2 relaxation time mapping on magnetic resonance imaging).
IMPACT


The findings from this study might identify an intervention capable of targeting the lingering quadriceps weakness after ACLR and in turn prevent deterioration in cartilage health after ACLR, thereby potentially improving function in this patient population.",2020,"Secondary outcome measures include isometric quadriceps strength, quadriceps activation, quadriceps muscle morphology (cross-sectional area), knee biomechanics (sagittal plane knee angles and moments), indexes of patient-reported function, and cartilage health (T1ρ and T2 relaxation time mapping on magnetic resonance imaging).
","['Anterior Cruciate Ligament Rehabilitation (MiACLR', '112 participants between the ages of 14 and 45\xa0years and with an ACL rupture will be included', 'University of Michigan']","['ECC or ECC placebo', 'NMES or NMES placebo', 'placebo', 'anterior cruciate ligament reconstruction (ACLR', 'NMES combined with ECC', 'NMES combined with ECC or NMES placebo combined with ECC placebo', 'High-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise (ECC']","['isokinetic quadriceps strength symmetry', 'isometric quadriceps strength, quadriceps activation, quadriceps muscle morphology (cross-sectional area), knee biomechanics (sagittal plane knee angles and moments), indexes of patient-reported function, and cartilage health (T1ρ and T2 relaxation time mapping on magnetic resonance imaging', 'strength recovery', 'quadriceps strength, biomechanical symmetry, and maintain cartilage health']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]","[{'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",112.0,0.408421,"Secondary outcome measures include isometric quadriceps strength, quadriceps activation, quadriceps muscle morphology (cross-sectional area), knee biomechanics (sagittal plane knee angles and moments), indexes of patient-reported function, and cartilage health (T1ρ and T2 relaxation time mapping on magnetic resonance imaging).
","[{'ForeName': 'Kazandra', 'Initials': 'K', 'LastName': 'Rodriguez', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, and Orthopaedic Rehabilitation and Biomechanics Laboratory, University of Michigan.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Garcia', 'Affiliation': 'School of Kinesiology, University of Michigan and Orthopaedic Rehabilitation and Biomechanics Laboratory, University of Michigan.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'School of Public Health, University of Michigan.'}, {'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Lepley', 'Affiliation': 'School of Kinesiology, University of Michigan and Orthopaedic Rehabilitation and Biomechanics Laboratory, University of Michigan Department of Radiology, Michigan Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Department of Radiology, Michigan Medicine, Ann Arbor, Michigan.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Wojtys', 'Affiliation': 'Michigan Medicine and Department of Orthopaedic Surgery, Michigan Medine.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Michigan Medicine and Department of Orthopaedic Surgery, Michigan Medine.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Angelini', 'Affiliation': 'School of Kinesiology, University of Michigan and Orthopaedic Rehabilitation and Biomechanics Laboratory, University of Michigan.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Ruffino', 'Affiliation': 'Department of Orthopaedic Surgery, Michigan Medicine.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bolley', 'Affiliation': 'MedSport, Michigan Medicine.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Block', 'Affiliation': 'MedSport, Michigan Medicine.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kellum', 'Affiliation': 'MedSport Michigan Medicine.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Swartout', 'Affiliation': 'MedSport Michigan Medicine.'}, {'ForeName': 'Riann M', 'Initials': 'RM', 'LastName': 'Palmieri-Smith', 'Affiliation': 'School of Kinesiology, University of Michigan, 401 Washtenaw Avenue, Ann Arbor, MI 48109 (USA); Orthopaedic Rehabilitation and Biomechanics Laboratory, University of Michigan; and Department of Orthopaedic Surgery, Michigan Medicine.'}]",Physical therapy,['10.1093/ptj/pzaa169']
2954,32939546,"Safety and Immunogenicity of Heterologous and Homologous Two Dose Regimens of Ad26- and MVA-Vectored Ebola Vaccines: A Randomized, Controlled Phase 1 Study.","BACKGROUND


This phase 1 placebo-controlled study assessed safety and immunogenicity of two-dose regimens of Ad26.ZEBOV (Ad26) and MVA-BN-Filo (MVA) vaccines with booster vaccination at Day 360.
METHODS


Healthy US adults (N = 164) randomized into 10 groups received saline placebo, standard or high doses of Ad26 or MVA in two-dose regimens in 7-, 14-, 28-, or 56-day intervals; eight groups received booster Ad26 or MVA vaccinations on Day 360. Participants reported solicited and unsolicited reactogenicity; we measured IgG binding, neutralizing antibodies and cellular immune responses to Ebolavirus (EBOV) glycoprotein.
RESULTS


All regimens were well tolerated with no serious vaccine-related adverse events. Heterologous (Ad26,MVA or MVA,Ad26) and homologous Ad26,Ad26 regimens induced humoral and cellular immune responses 21 days post-dose 2; responses were higher following heterologous regimens. Booster vaccination elicited anamnestic responses in all participants.
CONCLUSIONS


Both heterologous and homologous Ad26,MVA Ebola vaccine regimens are well tolerated in healthy adults, regardless of interval or dose level. Heterologous two-dose Ad26,MVA regimens containing an EBOV insert induce strong, durable humoral and cellular immune responses. Immunological memory was rapidly recalled by booster vaccination, suggesting Ad26 booster doses could be considered for individuals at risk of Ebola infection, who previously received the two-dose regimen.",2020,"Participants reported solicited and unsolicited reactogenicity; we measured IgG binding, neutralizing antibodies and cellular immune responses to Ebolavirus (EBOV) glycoprotein.
","['all participants', 'Healthy US adults (N = 164', 'healthy adults']","['saline placebo, standard or high doses of Ad26 or MVA', 'Ad26.ZEBOV (Ad26) and MVA-BN-Filo (MVA) vaccines', 'Heterologous and Homologous Two Dose Regimens of Ad26- and MVA-Vectored Ebola Vaccines', 'booster Ad26 or MVA vaccinations']","['tolerated with no serious vaccine-related adverse events', 'solicited and unsolicited reactogenicity', 'Immunological memory', 'IgG binding, neutralizing antibodies and cellular immune responses to Ebolavirus (EBOV) glycoprotein', 'durable humoral and cellular immune responses']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0052712', 'cui_str': 'AVM protocol'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C1449556', 'cui_str': 'Ebolavirus Vaccines'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021055', 'cui_str': 'Immunologic memory'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0949892', 'cui_str': 'Ebolavirus'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}]",164.0,0.105219,"Participants reported solicited and unsolicited reactogenicity; we measured IgG binding, neutralizing antibodies and cellular immune responses to Ebolavirus (EBOV) glycoprotein.
","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Goldstein', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands.'}, {'ForeName': 'Viki', 'Initials': 'V', 'LastName': 'Bockstal', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bart', 'Affiliation': 'Optimal Research, LLC; Rockville, MD; USA.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luhn', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands.'}, {'ForeName': 'Auguste', 'Initials': 'A', 'LastName': 'Gaddah', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Beerse, Belgium.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Callendret', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands.'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa586']
2955,32939553,"High-Dose Neonatal Vitamin A Supplementation to Bangladeshi Infants Increases the Percentage of CCR9-Positive Treg Cells in Infants with Lower Birthweight in Early Infancy, and Decreases Plasma sCD14 Concentration and the Prevalence of Vitamin A Deficiency at Two Years of Age.","BACKGROUND


Vitamin A (VA) stores are low in early infancy and may impair development of the immune system.
OBJECTIVE


This study determined if neonatal VA supplementation (VAS) affects the following: 1) development of regulatory T (Treg) cells; 2) chemokine receptor 9 (CCR9) expression, which directs mucosal targeting of immune cells; and 3) systemic endotoxin exposure as indicated by changed plasma concentrations of soluble CD14 (sCD14). Secondarily, VA status, growth, and systemic inflammation were investigated.
METHODS


In total, 306 Bangladeshi infants were randomly assigned to receive 50,000 IU VA or placebo (PL) within 48 h of birth, and immune function was assessed at 6 wk, 15 wk, and 2 y. Primary outcomes included the following: 1) peripheral blood Treg cells; 2) percentage of Treg, T, and B cells expressing CCR9; and 3) plasma sCD14. Secondary outcomes included the following: 4) VA status measured using the modified relative dose-response (MRDR) test and plasma retinol; 5) infant growth; and 6) plasma C-reactive protein (CRP). Statistical analysis identified group differences and interactions with sex and birthweight.
RESULTS


VAS increased (P = 0.004) the percentage of CCR9+ Treg cells (13.2 ± 1.37%) relative to PL (9.17 ± 1.15%) in children below the median birthweight but had the opposite effect (P = 0.04) in those with higher birthweight (VA, 9.13 ± 0.89; PL, 12.1 ± 1.31%) at 6 and 15 wk (values are combined mean ± SE). VAS decreased (P = 0.003) plasma sCD14 (1.56 ± 0.025 mg/L) relative to PL (1.67 ± 0.032 mg/L) and decreased (P = 0.034) the prevalence of VA deficiency (2.3%) relative to PL (9.2%) at 2 y.
CONCLUSIONS


Neonatal VAS enhanced mucosal targeting of Treg cells in low-birthweight infants. The decreased systemic exposure to endotoxin and improved VA status at 2 y may have been due to VA-mediated improvements in gut development resulting in improved barrier function and nutrient absorption. This trial was registered at clinicaltrials.gov as NCT01583972 and NCT02027610.",2020,"VAS decreased (P = 0.003) plasma sCD14 (1.56 ± 0.025 mg/L) relative to PL (1.67 ± 0.032 mg/L) and decreased (P = 0.034) the prevalence of VA deficiency (2.3%) relative to PL (9.2%) at 2 y.
CONCLUSIONS


Neonatal VAS enhanced mucosal targeting of Treg cells in low-birthweight infants.",['306 Bangladeshi infants'],"['neonatal VA supplementation (VAS', 'placebo (PL']","['1) peripheral blood Treg cells; 2) percentage of Treg, T, and B cells expressing CCR9; and 3) plasma sCD14', 'Plasma sCD14 Concentration', 'plasma sCD14', 'Secondarily, VA status, growth, and systemic inflammation', 'VAS', 'plasma concentrations of soluble CD14 (sCD14', 'percentage of CCR9+ Treg cells', '4) VA status measured using the modified relative dose-response (MRDR) test and plasma retinol; 5) infant growth; and 6) plasma C-reactive protein (CRP']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1872956', 'cui_str': 'CCR9 protein, human'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",306.0,0.392912,"VAS decreased (P = 0.003) plasma sCD14 (1.56 ± 0.025 mg/L) relative to PL (1.67 ± 0.032 mg/L) and decreased (P = 0.034) the prevalence of VA deficiency (2.3%) relative to PL (9.2%) at 2 y.
CONCLUSIONS


Neonatal VAS enhanced mucosal targeting of Treg cells in low-birthweight infants.","[{'ForeName': 'Shaikh M', 'Initials': 'SM', 'LastName': 'Ahmad', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'M Nazmul', 'Initials': 'MN', 'LastName': 'Huda', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Rubhana', 'Initials': 'R', 'LastName': 'Raqib', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md Jahangir', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md Nure Alam', 'Initials': 'MNA', 'LastName': 'Afsar', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Peerson', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Tanumihardjo', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa260']
2956,32944278,A mixed methods randomised feasibility trial investigating the management of benign paroxysmal positional vertigo in acute traumatic brain injury.,"Background


Traumatic brain injury (TBI) is the leading cause of long-term disability in working age adults. Recent studies show that most acute TBI patients demonstrate vestibular features of dizziness and imbalance, often from combined peripheral and central vestibular dysfunction. Effective treatment for vestibular impairments post-TBI is important given its significant adverse impact upon quality of life and employment prospects. The most frequent peripheral vestibular disorder in acute TBI is benign paroxysmal positional vertigo (BPPV), affecting approximately half of acute cases. Although there is effective treatment for idiopathic BPPV, there are no high-quality clinical data for post-TBI BPPV regarding its prevalence, natural history, which treatment is most effective and when is the best time to treat. In particular, observational studies suggest post-TBI BPPV may be recurrent, indicating that hyperacute treatment of BPPV may be futile. Given the potential hurdles and the lack of accurate post-TBI BPPV data, the current study was designed to provide information regarding the feasibility and optimal design of future large-scale prospective treatment studies that would compare different interventions and their timing for post-TBI BPPV.
Method


A multi-centre randomised mixed methods feasibility study design was employed. We aim to recruit approximately 75 acute TBI patients across a range of clinical severities, from three major trauma centres in London. Patients will be randomised to one of three treatment arms: (1) therapist-led manoeuvres, (2) patient-led exercises and (3) advice. Participants will be re-assessed by blinded outcome assessors at 4 and 12 weeks. Acceptability of the intervention will be obtained by patient interviews at the end of their treatment and therapist interviews at the end of the study. Primary outcomes relate to feasibility parameters including recruitment and retention rates, adverse events and intervention fidelity. We will also aim to provide a more accurate estimate of the prevalence of BPPV in TBI cases on the trauma ward.
Discussion


The multi-centre nature of our feasibility study will inform the design of a future prospective treatment trial of BPPV in acute TBI. Important parameters we will obtain from this study, key for designing a future prospective treatment study, include estimating the prevalence of BPPV in TBI patients admitted to UK major trauma wards, and elucidating both patient and care-provider barriers in delivering BPPV treatment.
Trial registration


ISRCTN, ISRCTN91943864. Registered on 10 February 2020.",2020,"We will also aim to provide a more accurate estimate of the prevalence of BPPV in TBI cases on the trauma ward.
","['acute traumatic brain injury', 'TBI patients admitted to UK major trauma wards, and elucidating both patient and care-provider barriers in delivering BPPV treatment', 'working age adults', '75 acute TBI patients across a range of clinical severities, from three major trauma centres in London']","['therapist-led manoeuvres, (2) patient-led exercises and (3) advice']","['feasibility parameters including recruitment and retention rates, adverse events and intervention fidelity']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.171934,"We will also aim to provide a more accurate estimate of the prevalence of BPPV in TBI cases on the trauma ward.
","[{'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'Brain And Vestibular Group (BAVG), Neuro-otology Unit, Department of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Marroney', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Beattie', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Newdick', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Tahtis', 'Affiliation': 'Brain And Vestibular Group (BAVG), Neuro-otology Unit, Department of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Burgess', 'Affiliation': ""Population of Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'School of Health Professions, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Seemungal', 'Affiliation': 'Brain And Vestibular Group (BAVG), Neuro-otology Unit, Department of Brain Sciences, Imperial College London, London, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00669-z']
2957,32944329,"Evaluation of ultrasound-guided erector spinae plane block for postoperative management of video-assisted thoracoscopic surgery: a prospective, randomized, controlled clinical trial.","Background


Video-assisted thoracoscopic surgery (VATS) is a commonly performed minimally invasive procedure that has led to lower levels of pain, as well as procedure-related mortality and morbidity. However, VATS requires analgesia that blocks both visceral and somatic nerve fibers for more effective pain control. This randomized controlled trial evaluated the effect of erector spinae plane block (ESPB) in the postoperative analgesia management of patients undergoing VATS.
Methods


We performed a prospective, randomized, single-center study between December 2018 and December 2019. Fifty-four patients were recruited to two equal groups (ESPB and control group). Following exclusion, 46 patients were included in the final analysis. Patients were randomly assigned to receive preoperative ultrasound-guided ESPB with either ropivacaine or saline. The primary outcome was the numeric rating scale (NRS) score, assessed 12 hours postoperatively. Secondary outcomes were the Riker Sedation-Agitation Scale (SAS) score for emergence agitation, postoperative cumulative opioid consumption, length of post-anesthesia care unit (PACU) stay, incidence of postoperative nausea and vomiting (PONV) and dizziness, and ESPB-related adverse events.
Results


The NRS in the ESPB group during the postoperative period immediately after PACU admission was significantly lower than that in the control group (5.96±1.68 and 7.59±1.18, respectively; P<0.001) and remained lower until 6 hours postoperatively (P=0.001 at 1 hour and P=0.005 at 6 hours). At 12 hours postoperatively, NRS scores were not significantly different between groups (P=0.12). The median [interquartile range (IQR)] of the postoperative rescue pethidine consumption in PACU was significantly lower [25 mg (25 mg)] in the ESPB group than that in the control group [50 mg (56.2 mg); P=0.006]. The median (IQR) of PACU residual time was significantly lower [25 min (10 min)] in the ESPB group than that in the control group [30 min (15 min); P=0.034]. The median (IQR) Riker SAS was also lower in the ESPB group [4 (1.0)] than that in the control group [5 (1.25); P<0.001] in PACU.
Conclusions


A single preoperative injection of ESPB with ropivacaine may improve acute postoperative analgesia and emergence agitation in patients undergoing VATS.",2020,"At 12 hours postoperatively, NRS scores were not significantly different between groups (P=0.12).","['December 2018 and December 2019', 'Fifty-four patients were recruited to two equal groups (ESPB and control group', '46 patients were included in the final analysis', 'patients undergoing VATS']","['ultrasound-guided erector spinae plane block', 'ropivacaine', 'VATS', '\n\n\nVideo-assisted thoracoscopic surgery (VATS', 'preoperative ultrasound-guided ESPB with either ropivacaine or saline', 'video-assisted thoracoscopic surgery', 'erector spinae plane block (ESPB']","['Riker Sedation-Agitation Scale (SAS) score for emergence agitation, postoperative cumulative opioid consumption, length of post-anesthesia care unit (PACU) stay, incidence of postoperative nausea and vomiting (PONV) and dizziness, and ESPB-related adverse events', 'numeric rating scale (NRS) score', 'postoperative rescue pethidine consumption in PACU', 'NRS scores', 'median (IQR) of PACU residual time', 'median [interquartile range (IQR', 'median (IQR) Riker SAS', 'acute postoperative analgesia and emergence agitation']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",54.0,0.253921,"At 12 hours postoperatively, NRS scores were not significantly different between groups (P=0.12).","[{'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Pyoung On', 'Initials': 'PO', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji-Eun', 'Initials': 'JE', 'LastName': 'Yeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Du-Young', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Journal of thoracic disease,['10.21037/jtd-20-689']
2958,32944407,"Outcomes of patients treated with SVILE  vs.  P-GemOx for extranodal natural killer/T-cell lymphoma, nasal type: a prospective, randomized controlled study.","Objective:  To compare the efficacy and safety of the novel SVILE regimen with the P-GemOx regimen in patients with newly diagnosed extranodal natural killer/T-cell lymphoma, nasal type (ND-ENKTL).  Methods : From April 2015 to July 2018, 103 patients with ND-ENKTL were randomly assigned to SVILE (experimental group) or P-GemOx (control group) chemotherapy followed by radiotherapy and consolidation chemotherapy. The primary endpoint was the overall response rate after 3 cycles of chemotherapy, and secondary study endpoints were complete response (CR), progression-free survival (PFS), and overall survival (OS). Safety was also evaluated.  Results:  There were no significant differences in baseline characteristics in the experimental  vs.  control groups. In experimental and control groups, respectively, the overall response rates were 91.7%  vs.  97.0% for stage I/II and 75.0%  vs.  72.2% for stage III/IV. The CR rates were 83.4%  vs.  97.0% for stage I/II and 68.8%  vs.  61.1% for stage III/IV. None of those differences were significant. There was no significant difference in PFS and OS between groups and between patients in stage I/II and stage III/IV. The 3-year PFS and OS in stage I/II were 88.3%  vs.  93.3% and 88.8%  vs.  97.0%, respectively. The 3-year PFS and OS in stage III/IV were 46.2%  vs.  65.7% and 68.8%  vs.  72.2%, respectively. The common adverse events were hematological toxicity, hepatotoxicity, and coagulation abnormalities, which were found to be reversible with supportive therapy.  Conclusions:  The novel SVILE regimen has comparable effects to those of P-GemOx in patients with ND-ENKTL and is well tolerated. SVILE is a therapeutic option for ND-ENKTL.",2020,There was no significant difference in PFS and OS between groups and between patients in stage I/II and stage III/IV.,"['patients treated with SVILE  vs.  P-GemOx for extranodal natural killer/T-cell lymphoma, nasal type', 'April 2015 to July 2018, 103 patients with ND', 'patients with newly diagnosed extranodal natural killer/T-cell lymphoma, nasal type (ND-ENKTL']","['novel SVILE regimen with the P-GemOx regimen', 'SVILE', 'SVILE (experimental group) or P-GemOx (control group) chemotherapy followed by radiotherapy and consolidation chemotherapy']","['efficacy and safety', 'overall response rates', 'overall response rate', 'complete response (CR), progression-free survival (PFS), and overall survival (OS', 'PFS and OS', '3-year PFS and OS', 'CR rates', 'hematological toxicity, hepatotoxicity, and coagulation abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0079772', 'cui_str': 'T-cell lymphoma (clinical)'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1699231', 'cui_str': 'gemcitabine-oxaliplatin regimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",103.0,0.0646027,There was no significant difference in PFS and OS between groups and between patients in stage I/II and stage III/IV.,"[{'ForeName': 'Liqiang', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Cong', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yao', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}]",Cancer biology & medicine,['10.20892/j.issn.2095-3941.2020.0160']
2959,32944495,"""Effect of local application of simvastatin in bone regeneration of peri-apical defects-a clinico-radiographic study.","Objective


The present study evaluates and compares the effectiveness of Simvastatin (SIM), Hydroxyapatite (HA), and platelet-rich fibrin (PRF) in bone regeneration of periapical defects.
Material& method


Thirty-nine patients were selected and randomized into three groups, Group 1: HA (n = 13), Group 2: PRF (n = 13), Group 3: SIM (n = 13). After completion of RCT and apicoectomy, the grafts were placed locally in the defect and sutured.
Results


At the end of twelve months, postoperative symptoms and radiographic analysis assessed the outcome of the treatment.
Conclusion


Intragroup analysis of CBCT- Periapical Index (PAI) scores at 6th and 12th month revealed a significant change in the SIM group (p = 0.018 and 0.001 respectively), compared to PRF (p = 0.026 and 0.001 respectively) and HA (p = 0.053 and 0.039 respectively). Intergroup analysis of change in the level of CBCT-PAI score was highly significant (p = 0.003).SIM caused a more considerable change in the level of CBCT-PAI score compared to other groups, thereby indicating a faster rate of bone regeneration.",2020,"Intergroup analysis of change in the level of CBCT-PAI score was highly significant (p = 0.003).SIM caused a more considerable change in the level of CBCT-PAI score compared to other groups, thereby indicating a faster rate of bone regeneration.",['Material& method\n\n\nThirty-nine patients'],"['simvastatin', 'Simvastatin (SIM), Hydroxyapatite (HA), and platelet-rich fibrin (PRF']","['level of CBCT-PAI score', 'CBCT- Periapical Index (PAI) scores']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen activator inhibitor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",39.0,0.0890472,"Intergroup analysis of change in the level of CBCT-PAI score was highly significant (p = 0.003).SIM caused a more considerable change in the level of CBCT-PAI score compared to other groups, thereby indicating a faster rate of bone regeneration.","[{'ForeName': 'Sweety', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Conservative Dentistry and Endodontics King George's Medical University, Lucknow, India.""}, {'ForeName': 'Promila', 'Initials': 'P', 'LastName': 'Verma', 'Affiliation': ""Conservative Dentistry and Endodontics King George's Medical University, Lucknow, India.""}, {'ForeName': 'Aseem Prakash', 'Initials': 'AP', 'LastName': 'Tikku', 'Affiliation': ""Conservative Dentistry and Endodontics King George's Medical University, Lucknow, India.""}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': ""Conservative Dentistry and Endodontics King George's Medical University, Lucknow, India.""}, {'ForeName': 'Rakesh Kumar', 'Initials': 'RK', 'LastName': 'Yadav', 'Affiliation': ""Conservative Dentistry and Endodontics King George's Medical University, Lucknow, India.""}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Bharti', 'Affiliation': ""Conservative Dentistry and Endodontics King George's Medical University, Lucknow, India.""}, {'ForeName': 'Rhythm', 'Initials': 'R', 'LastName': 'Bains', 'Affiliation': ""Conservative Dentistry and Endodontics King George's Medical University, Lucknow, India.""}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2020.08.014']
2960,32940628,Efficacy and Safety of nab-Paclitaxel vs Paclitaxel on Survival in Patients With Platinum-Refractory Metastatic Urothelial Cancer: The Canadian Cancer Trials Group BL.12 Randomized Clinical Trial.,"Importance


Treatment options for platinum-refractory metastatic urothelial cancer (mUC) are limited, and outcomes remain poor. Nab-paclitaxel is an albumin-bound formulation of paclitaxel showing promising activity and tolerability in a prior single-arm trial.
Objectives


To evaluate the efficacy and safety of nab-paclitaxel vs paclitaxel in platinum-refractory mUC.
Design, Setting, and Participants


In this investigator-initiated, open-label, phase 2 randomized clinical trial conducted across Canada and Australia from January 2014 to April 2017, eligible patients had histologically confirmed, radiologically evident mUC of the urinary tract. Mixed histologic findings, except small cell, were permitted provided UC was the predominant histologic finding. All patients had received platinum-based chemotherapy either in the metastatic setting or were within 12 months of perioperative chemotherapy. Patients with prior taxane chemotherapy were not included. Patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2 and adequate organ function.
Interventions


Patients were randomized to nab-paclitaxel, 260 mg/m2, or paclitaxel, 175 mg/m2, every 3 weeks.
Main Outcomes and Measures


The primary end point was progression-free survival (PFS).
Results


Among 199 patients, median age was 67 (range, 24-88) years; 144 (72%) were men; 167 (84%) were ECOG PS 0-1; 59 (30%) had liver metastases; and 110 (55%) were within 6 months of prior platinum-based chemotherapy. At a median follow-up of 16.4 months, there was no significant difference between nab-paclitaxel vs paclitaxel for median PFS (3.4 months vs 3.0 months; hazard ratio [HR], 0.92; 90% CI, 0.68-1.23; 1-sided P = .31). Median overall survival was 7.5 months for nab-paclitaxel vs 8.8 months for paclitaxel (HR, 0.95; 90% CI, 0.70-1.30; 1-sided P = .40); and objective response rate (ORR) was 22% for nab-paclitaxel vs 25% for paclitaxel (P = .97). Grade 3/4 adverse events were more frequent with nab-paclitaxel (64/97 [66%]) compared with paclitaxel (45/97 [46%]), P = .009; but peripheral sensory neuropathy was similar (all grades, 72/97 [74%] vs 64/97 [66%]; grade 3/4, 7/97 [7%] vs 3/97 [3%]; P = .27). There were no apparent differences in scores for health-related quality of life.
Conclusions and Relevance


In this open-label, phase 2 randomized clinical trial of patients with platinum-refractory mUC, nab-paclitaxel had similar efficacy to paclitaxel; but worse toxic effects. The ORR with either taxane, however, was higher than previously reported and similar to those reported for the immune checkpoint inhibitors, suggesting that the taxanes remain a reasonable option in this setting.
Trial Registration


ClinicalTrials.gov Identifier: NCT02033993.",2020,"At a median follow-up of 16.4 months, there was no significant difference between nab-paclitaxel vs paclitaxel for median PFS (3.4 months vs 3.0 months; hazard ratio [HR], 0.92; 90% CI, 0.68-1.23; 1-sided P = .31).","['Patients With Platinum-Refractory Metastatic Urothelial Cancer', ' median age was 67 (range, 24-88) years; 144 (72%) were men', 'Patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2 and adequate organ function', 'Canada and Australia from January 2014 to April 2017, eligible patients had histologically confirmed, radiologically evident mUC of the urinary tract', 'patients with platinum-refractory mUC, nab', '199 patients', 'platinum-refractory metastatic urothelial cancer (mUC', 'Patients with prior']","['perioperative chemotherapy', 'nab-paclitaxel vs paclitaxel', 'paclitaxel', 'taxane chemotherapy', 'Nab-paclitaxel', 'taxane', 'nab-Paclitaxel vs Paclitaxel', 'nab-paclitaxel, 260 mg/m2, or paclitaxel', 'platinum-based chemotherapy']","['objective response rate (ORR', 'Grade 3/4 adverse events', 'efficacy and safety', 'peripheral sensory neuropathy', 'Efficacy and Safety', 'Survival', 'toxic effects', 'scores for health-related quality of life', 'Median overall survival', 'liver metastases', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.145574,"At a median follow-up of 16.4 months, there was no significant difference between nab-paclitaxel vs paclitaxel for median PFS (3.4 months vs 3.0 months; hazard ratio [HR], 0.92; 90% CI, 0.68-1.23; 1-sided P = .31).","[{'ForeName': 'Srikala S', 'Initials': 'SS', 'LastName': 'Sridhar', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Normand', 'Initials': 'N', 'LastName': 'Blais', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Tran', 'Affiliation': 'Peter MacCallum Cancer Centre, Victoria, Australia.'}, {'ForeName': 'M Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': 'Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'North', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney, Australia.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'British Columbia Cancer Agency Vancouver, British Columbia, Canada.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Fleshner', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Robinson', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Som D', 'Initials': 'SD', 'LastName': 'Mukherjee', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Rahim', 'Affiliation': 'Stronach Regional Cancer Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winquist', 'Affiliation': 'London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Booth', 'Affiliation': ""Department of Oncology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Nghia Trung', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Hopital Charles-LeMoyne, Montreal, Quebec, Canada.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Beardsley', 'Affiliation': 'Frankston Hospital/Cabrini/Monash University, Parkdale, Australia.'}, {'ForeName': 'Nimira S', 'Initials': 'NS', 'LastName': 'Alimohamed', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Gail T', 'Initials': 'GT', 'LastName': 'McDonald', 'Affiliation': ""Canadian Cancer Trials Group (CCTG), Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Keyue', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': ""Canadian Cancer Trials Group (CCTG), Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group (CCTG), Queen's University, Kingston, Ontario, Canada.""}]",JAMA oncology,['10.1001/jamaoncol.2020.3927']
2961,32940642,Association of α-Melanocyte-Stimulating Hormone With Corneal Endothelial Cell Survival During Oxidative Stress and Inflammation-Induced Cell Loss in Donor Tissue.,"Importance


Corneal endothelial cell (CEnC) damage and loss are major issues in eye banking and transplantation. The underlying mechanisms for CEnC loss are incompletely understood, and cytoprotective strategies that enhance CEnC viability could have a major effect on donor tissue quality and graft survival.
Objective


To investigate the cytoprotective role of neuropeptide α-melanocyte-stimulating hormone (α-MSH) in preventing CEnC loss in eye bank cold-stored corneas under oxidative and inflammatory cytokine-induced stress.
Design, Setting, and Participants


This single-center comparative research study conducted ex vivo experiments using 16 pairs of research-grade human donor corneas (courtesy of Eversight Eye Bank). Data were collected from June 2018 to November 2019, and data were analyzed from December 2019 to January 2020.
Exposures


Two corneas from the same donor were randomized to either control or 0.1 mmol/L of α-MSH treatment and then subjected to oxidative stress (1.4 mmol/L of hydrogen peroxide-phosphate-buffered saline for 15 minutes at 37 °C; n = 8 pairs) or cytokine-induced stress (100 ng/mL of tumor necrosis factor-α and 100 ng/mL of interferon γ for 18 hours at 37 °C; n = 8 pairs). Corneas were then stored at 4 °C. Specular images were taken at baseline and repeated twice per week using a calibrated wide-field specular microscope. CEnC viability was assessed using a fluorescent live/dead viability assay.
Main Outcome and Measures


Endothelial morphometry analysis, central corneal thickness measurements, and percentage of dead cells at day 11.
Results


Of 16 donors who provided corneas, 9 (56%) were male, and the mean (SD) age was 57.9 (12.4) years. Corneas were paired, and baseline parameters were comparable between all groups. At all time points, CEnC loss was lower in the α-MSH groups compared with the control groups. This difference was statistically significant after cytokine-induced stress (20.2% vs 35.2%; sample estimate of median, -14.9; 95% CI, -23.6 to -6.3; P = .008). Compared with the control group, α-MSH treatment resulted in a smaller increase in central corneal thickness (cytokine-induced stress: 89.3 μm vs 169.8 μm; sample estimate of median, -84.9; 95% CI, -131.5 to -41.6; P = .008; oxidative stress: 43.6 μm vs 111.9 μm; sample estimate of median, -68.8; 95% CI, -100.0 to -34.5; P = .008) and a smaller proportion of cell death (cytokine-induced stress: 2.7% vs 10.4%; difference, -7.7; 95% CI, -13.1 to -2.4; P = .01; oxidative stress: 2.9% vs 12.4%; difference, 9.5; 95% CI, 5.1 to 13.9; P = .006).
Conclusions and Relevance


In this study, α-MSH treatment attenuated CEnC loss during cold storage after acute oxidative and cytokine-induced stress in human eye bank cold-stored corneas. These data suggest that supplementation of corneal storage solution with α-MSH may positively affect CEnC survival after transplant and protect the endothelium from proinflammatory cytokines and oxidative stress after full-thickness or endothelial keratoplasty, which is particularly valuable in patients at high risk of graft failure.",2020,"Compared with the control group, α-MSH treatment resulted in a smaller increase in central corneal thickness (cytokine-induced stress: 89.3 μm vs 169.8 μm; sample estimate of median, -84.9; 95% CI, -131.5 to -41.6; P = .008; oxidative stress: 43.6 μm vs 111.9 μm; sample estimate of median, -68.8; 95% CI, -100.0 to -34.5; P = .008) and a smaller proportion of cell death (cytokine-induced stress: 2.7% vs 10.4%; difference, -7.7; 95% CI, -13.1 to -2.4; P = .01; oxidative stress: 2.9% vs 12.4%; difference, 9.5; 95% CI, 5.1 to 13.9; P = .006).
","['Data were collected from June 2018 to November 2019, and data were analyzed from December 2019 to January 2020', '16 pairs of research-grade human donor corneas (courtesy of Eversight Eye Bank', '16 donors who provided corneas, 9 (56%) were male, and the mean (SD) age was 57.9 (12.4) years']","['control or 0.1 mmol/L of α-MSH treatment and then subjected to oxidative stress (1.4 mmol/L of hydrogen peroxide-phosphate-buffered saline', 'α-Melanocyte-Stimulating Hormone With Corneal Endothelial Cell Survival', 'factor-α and 100 ng/mL of interferon γ', 'α-MSH', 'neuropeptide α-melanocyte-stimulating hormone (α-MSH', 'cytokine-induced stress (100 ng/mL of tumor necrosis']","['CEnC viability', 'CEnC loss', 'cell death', 'oxidative stress', 'central corneal thickness (cytokine-induced stress', 'cytokine-induced stress', 'CEnC survival', 'Measures\n\n\nEndothelial morphometry analysis, central corneal thickness measurements, and percentage of dead cells at day 11']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0015394', 'cui_str': 'Eye Banks'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0026667', 'cui_str': 'Melanocyte stimulating hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis'}]","[{'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C2717756', 'cui_str': 'Corneal endothelial cell loss'}, {'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0200760', 'cui_str': 'Morphometric analysis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.123186,"Compared with the control group, α-MSH treatment resulted in a smaller increase in central corneal thickness (cytokine-induced stress: 89.3 μm vs 169.8 μm; sample estimate of median, -84.9; 95% CI, -131.5 to -41.6; P = .008; oxidative stress: 43.6 μm vs 111.9 μm; sample estimate of median, -68.8; 95% CI, -100.0 to -34.5; P = .008) and a smaller proportion of cell death (cytokine-induced stress: 2.7% vs 10.4%; difference, -7.7; 95% CI, -13.1 to -2.4; P = .01; oxidative stress: 2.9% vs 12.4%; difference, 9.5; 95% CI, 5.1 to 13.9; P = .006).
","[{'ForeName': 'Zala', 'Initials': 'Z', 'LastName': 'Lužnik', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston.'}, {'ForeName': 'Zhongmou', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston.'}, {'ForeName': 'Hayate', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Taylor', 'Affiliation': 'Department of Ophthalmology, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Ula V', 'Initials': 'UV', 'LastName': 'Jurkunas', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Dana', 'Affiliation': 'Schepens Eye Research Institute of Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3413']
2962,32940653,Efficacy of Timolol in a Novel Intranasal Thermosensitive Gel for Hereditary Hemorrhagic Telangiectasia-Associated Epistaxis: A Randomized Clinical Trial.,"Importance


Other than nasal moisturizers, no standard-of-care medical therapy exists for epistaxis in hereditary hemorrhagic telangiectasia (HHT). With epistaxis as the greatest cause of morbidity in patients with HHT, there is a need to identify effective topical therapies.
Objective


To determine the efficacy and safety of an intranasal timolol thermosensitive gel vs placebo thermosensitive gel in treating HHT-associated epistaxis.
Design, Setting, and Participants


This double-blind, placebo-controlled randomized clinical trial was conducted from October 29, 2019, to May 20, 2020, at a tertiary care center. A total of 27 patients with HHT and moderate-to-severe epistaxis were recruited and included in this prespecified analysis: 14 in the timolol group and 13 in the placebo group. Inclusion criteria included (1) age 18 years or older, (2) clinical or genetic diagnosis of HHT, (3) screening Epistaxis Severity Score (ESS) of 4 or greater and 2 or more nosebleeds cumulatively lasting at least 5 minutes per week, (4) stable epistaxis pattern over the preceding 3 months, and (5) no change in epistaxis treatment or nasal hygiene regimen in the preceding month. Exclusion criteria included (1) contraindications to systemic β-blocker administration, (2) use of medications interacting with timolol, (3) use of antiangiogenic medications in the last month before recruitment, and (4) use of anticoagulants, antiplatelets, or fibrinolytic therapies within the last month.
Interventions


Novel thermosensitive intranasal timolol (0.1%) gel vs placebo thermosensitive gel applied twice daily to each nostril for 8 weeks.
Main Outcomes and Measures


The primary outcome was the median change in ESS and percentage of participants reaching the minimal clinically important difference in ESS. Secondary outcomes were changes in Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores, Nasal Outcome Score for Epistaxis in Hereditary Hemorrhagic Telangiectasia, and hemoglobin level.
Results


Of 27 participants randomized (median [range] age, 55 [20-76] years; 14 women [52%]; 25 White [93%]), a total of 23 patients with HHT completed the primary outcome measure. Within the timolol gel and placebo gel groups, respectively, the median change (range) in ESS was 2.32 (0.22 to 5.97) vs 1.96 (-0.91 to 5.98), and 9 of 11 (82%) vs 9 of 12 (75%) participants experienced a clinically meaningful improvement in ESS. Twenty-two of the 23 participants (96%) reported improvement via the Clinical Global Impression-Improvement score, with 81% vs 58% of participants reporting reduced severity of epistaxis in the timolol vs placebo group, respectively. Of participants completing the Nasal Outcome Score for Epistaxis in HHT at follow-up visit, 7 of 10 (70%) in the timolol group achieved a clinically important difference vs 5 of 10 (50%) in the placebo group. There was no change in hemoglobin level between or within groups. Zero participants in the placebo group and 2 of 13 (15%) in the timolol group withdrew because of adverse events.
Conclusions and Relevance


Thermosensitive gel, alone or in combination with timolol, was highly effective in reducing HHT-associated epistaxis. The timolol group had greater improvement in epistaxis and quality of life than the placebo group, but effect estimates were imprecise, and no definitive conclusions on the superiority of timolol can be drawn. Physicians treating patients with HHT-associated epistaxis should consider a thermosensitive gel (with or without timolol) for their patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT04139018.",2020,"The timolol group had greater improvement in epistaxis and quality of life than the placebo group, but effect estimates were imprecise, and no definitive conclusions on the superiority of timolol can be drawn.","['hereditary hemorrhagic telangiectasia (HHT', '27 participants randomized (median [range] age, 55 [20-76] years; 14 women [52%]; 25 White [93%]), a total of 23 patients with HHT completed the primary outcome measure', 'Hereditary Hemorrhagic Telangiectasia', 'patients with HHT', '27 patients with HHT and moderate-to-severe epistaxis', 'Exclusion criteria included (1) contraindications to systemic β-blocker administration, (2) use of medications interacting with', 'Inclusion criteria included (1) age 18 years or older, (2) clinical or genetic diagnosis of HHT, (3) screening Epistaxis Severity Score (ESS) of 4 or greater and 2 or more nosebleeds cumulatively lasting at least 5 minutes per week, (4) stable epistaxis pattern over the preceding 3 months, and (5) no change in epistaxis treatment or nasal hygiene regimen in the preceding month', 'October 29, 2019, to May 20, 2020, at a tertiary care center', 'Associated Epistaxis', 'Physicians treating patients with HHT-associated epistaxis']","['timolol (0.1%) gel vs placebo thermosensitive gel', 'intranasal timolol thermosensitive gel vs placebo thermosensitive gel', 'timolol, (3) use of antiangiogenic medications', 'thermosensitive gel (with or without timolol', 'placebo', 'Timolol', 'timolol gel and placebo gel', 'timolol']","['changes in Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores, Nasal Outcome Score for Epistaxis in Hereditary Hemorrhagic Telangiectasia, and hemoglobin level', 'median change (range) in ESS', 'hemoglobin level', 'median change in ESS and percentage of participants reaching the minimal clinically important difference in ESS', 'Nasal Outcome Score for Epistaxis in HHT', 'efficacy and safety', 'severity of epistaxis', 'improvement via the Clinical Global Impression-Improvement score', 'epistaxis and quality of life', 'clinically meaningful improvement in ESS']","[{'cui': 'C0039445', 'cui_str': 'Osler hemorrhagic telangiectasia syndrome'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0596087', 'cui_str': 'Angiogenesis inhibitor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039445', 'cui_str': 'Osler hemorrhagic telangiectasia syndrome'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",27.0,0.380496,"The timolol group had greater improvement in epistaxis and quality of life than the placebo group, but effect estimates were imprecise, and no definitive conclusions on the superiority of timolol can be drawn.","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Peterson', 'Affiliation': 'Clinical Outcomes Research Office, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Jake J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Outcomes Research Office, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Kallogjeri', 'Affiliation': 'Clinical Outcomes Research Office, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Schneider', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Murali M', 'Initials': 'MM', 'LastName': 'Chakinala', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Jay F', 'Initials': 'JF', 'LastName': 'Piccirillo', 'Affiliation': 'Clinical Outcomes Research Office, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.3025']
2963,32940667,Selection of fewer dominant follicles in Trio carriers given GnRH antagonist and LH action replaced by nonpulsatile hCG.†.,"Studying selection of multiple dominant follicles (DF) in monovulatory species can advance our understanding of mechanisms regulating selection of single or multiple DF. Carriers of the bovine high fecundity Trio allele select multiple DF whereas half-sib noncarriers select a single DF. This study compared follicle selection during endogenous gonadotropin pulses vs during ablation of pulses with Acyline (GnRH-antagonist) and LH action replaced with nonpulsatile hCG treatment in Trio carriers (n = 28) vs noncarriers (n = 32). On D1.5 (D0 = ovulation), heifers were randomized: 1) Control, untreated; 2) Acyline, two i.m. doses (D1.5 and D3) of 3 μg/kg; 3) hCG, single i.m. dose of 50 IU hCG on D1.5 followed by daily doses of 100 IU; and 4) Acyline+hCG. Treatments with nonpulsatile hCG were designed to replace LH action in heifers treated with Acyline. Acyline treatment resulted in cessation of follicle growth on D3 with smaller (P < 0.0001) maximum follicle diameter in Trio carriers (6.6 ± 0.2 mm) than noncarriers (8.7 ± 0.4 mm). Replacement of LH action (hCG) reestablished follicle diameter deviation and maximum diameter of DF in both genotypes (8.9 ± 0.3 mm and 13.1 ± 0.5 mm; P < 0.0001). Circulating FSH was greater in Acyline-treated than in controls. Finally, Acyline+hCG decreased (P < 0.0001) the number of DF from 2.7 ± 0.2 to 1.3 ± 0.2 in Trio carriers, with most heifers having only one DF. This demonstrates the necessity for LH in acquisition of dominance in Trio carriers (~6.5 mm) and noncarriers (~8.5 mm) and provides evidence for a role of GnRH-induced FSH/LH pulses in selection of multiple DF in Trio carriers and possibly other physiologic situations with increased ovulation rate.",2020,"Finally, Acyline+hCG decreased (P < 0.0001)",['Trio carriers (n\xa0=\xa028) vs noncarriers (n\xa0=\xa032'],"['50\xa0IU hCG', 'Acyline+hCG', 'endogenous gonadotropin pulses vs during ablation of pulses with Acyline (GnRH-antagonist) and LH action replaced with nonpulsatile hCG', 'nonpulsatile hCG', 'LH action (hCG']","['Circulating FSH', 'cessation of follicle growth']","[{'cui': 'C1448979', 'cui_str': 'TRIO protein, human'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0668202', 'cui_str': 'acyline'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.113057,"Finally, Acyline+hCG decreased (P < 0.0001)","[{'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Gomez-León', 'Affiliation': 'Department of Animal and Dairy Sciences, University of Wisconsin-Madison (UW-Madison), USA.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Andrade', 'Affiliation': 'Department of Animal and Dairy Sciences, University of Wisconsin-Madison (UW-Madison), USA.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Animal and Dairy Sciences, University of Wisconsin-Madison (UW-Madison), USA.'}, {'ForeName': 'Sadrollah Molaei', 'Initials': 'SM', 'LastName': 'Moghbeli', 'Affiliation': 'Department of Animal and Dairy Sciences, University of Wisconsin-Madison (UW-Madison), USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'García-Guerra', 'Affiliation': 'Department of Animal Sciences, The Ohio State University, Columbus OH USA.'}, {'ForeName': 'O J', 'Initials': 'OJ', 'LastName': 'Ginther', 'Affiliation': 'Eutheria Foundation, Cross Plains, Wisconsin USA.'}, {'ForeName': 'Milo C', 'Initials': 'MC', 'LastName': 'Wiltbank', 'Affiliation': 'Department of Animal and Dairy Sciences, University of Wisconsin-Madison (UW-Madison), USA.'}]",Biology of reproduction,['10.1093/biolre/ioaa167']
2964,32940731,Low polyethylene creep and wear following mobile-bearing unicompartmental knee replacement.,"PURPOSE


The Oxford unicompartmental knee replacement (UKR) has a fully congruent mobile bearing to minimise wear. However, with younger higher demand patients, wear remains a concern. The aim of this study was to quantify the wear rate of Phase 3 Oxford UKR bearings over the course of 5 years and to identify the factors that influence it.
METHODS


40 medial Oxford UKRs recruited for a randomised study of cemented and cementless fixation were studied with Radiostereometric analysis (RSA) at 1 week, 3 months, 6 months, 1 year, 2 years, and 5 years post-operatively and bearing thickness was calculated. Penetration, defined as the change in thickness compared to the 1-week measurement, was determined. Creep (early penetration) and wear (late penetration at a constant rate) were calculated. The influence of demographic factors, Oxford Knee Score (OKS), Tegner score, fixation and bearing overhang (determined by RSA) on wear was analysed.
RESULTS


After 6 months the penetration rate was constant, indicating that wear alone was occurring. The wear rate was 0.07 mm/year (SD 0.03). The creep was 0.06 mm with about 95% occurring during the first 3 months. There was no significant relationship between fixation (cemented/cementless), age, component size, OKS and Tegner score with wear rate. Increasing BMI was associated with decreasing wear (p = 0.042). 37/40 bearings overhung the tibia to some extent and 23/40 overhung the tibia medially. An increase in the area of overhang (p = 0.036), amount of medial overhang (p = 0.028) and distance between the bearing and tibial wall (p = 0.019) were associated with increased wear. Bearings that did not overhang (0.06 mm/year) had less wear (p = 0.025) than those that did (0.08 mm/year). There was no relationship (p = 0.6) between the femoral contact area and wear.
CONCLUSION


During the first three to six months after implantation, the bearing becomes 0.06 mm thinner due to creep. The combined wear rate of the upper and lower surfaces of the bearing is constant (0.07 mm/year). The wear is lower if the bearing does not overhang the tibia so surgeons should aim for the bearing to be close to the tibial wall. The orientation of the femoral component does not influence wear.
LEVEL OF EVIDENCE


Retrospective Study, Level III.",2020,"An increase in the area of overhang (p = 0.036), amount of medial overhang (p = 0.028) and distance between the bearing and tibial wall (p = 0.019) were associated with increased wear.",['40 medial Oxford UKRs recruited for a randomised study of'],"['Oxford unicompartmental knee replacement (UKR', 'Low polyethylene creep and wear following mobile-bearing unicompartmental knee replacement', 'cemented and cementless fixation']","['demographic factors, Oxford Knee Score (OKS), Tegner score, fixation and bearing overhang (determined by RSA', 'penetration rate', 'wear rate', 'fixation (cemented/cementless), age, component size, OKS and Tegner score with wear rate', 'femoral contact area and wear', 'Creep (early penetration) and wear (late penetration at a constant rate', 'Increasing BMI', 'amount of medial overhang', 'area of overhang']","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0231254', 'cui_str': 'Increased body mass index'}, {'cui': 'C0205098', 'cui_str': 'Medial'}]",,0.0480397,"An increase in the area of overhang (p = 0.036), amount of medial overhang (p = 0.028) and distance between the bearing and tibial wall (p = 0.019) were associated with increased wear.","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Ghosh', 'Affiliation': 'Oxford Orthopaedic Engineering Centre, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hasan R', 'Initials': 'HR', 'LastName': 'Mohammad', 'Affiliation': 'Oxford Orthopaedic Engineering Centre, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Martin', 'Affiliation': 'Oxford Orthopaedic Engineering Centre, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Campi', 'Affiliation': 'Oxford Orthopaedic Engineering Centre, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Murray', 'Affiliation': 'Oxford Orthopaedic Engineering Centre, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Mellon', 'Affiliation': 'Oxford Orthopaedic Engineering Centre, NDORMS, University of Oxford, Oxford, UK. Stephen.Mellon@ndorms.ox.ac.uk.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06243-7']
2965,32940732,No differences in clinical outcomes or isokinetic performance between cruciate-substituting ultra-congruent and posterior stabilized total knee arthroplasties: a randomized controlled trial.,"PURPOSE


Whether ultra-congruent (UC) or posterior cruciate ligament-stabilized (PS) inserts should be used in posterior cruciate ligament (PCL)-sacrificing total knee arthroplasty (TKA) remains debatable. Therefore, the aim of this prospective randomized controlled study was to compare the isokinetic performance and clinical outcomes of these inserts in PCL-sacrificing TKA.
METHODS


Sixty-six patients diagnosed with primary knee osteoarthritis were randomly assigned to either the UC or the PS group. There were no significant differences between the groups in terms of age, body mass index or sex. The Knee Society score (KSS) and isokinetic performance results for each patient were recorded preoperatively and at 3, 6 and 12 months postoperatively. The physiatrist that performed the isokinetic tests and the patients were blinded to the study groups.
RESULTS


There were no significant differences between the groups in terms of the preoperative KSS or isokinetic performance. Gradual improvement in the KSS was observed in both groups, but no significant differences were detected between the groups during the whole follow-up period. The UC and PS groups exhibited similar peak extension and flexion torque values normalized to body weight at 3, 6 and 12 months postoperatively (p > 0.05).
CONCLUSION


The use of UC or PS inserts in TKA did not affect the clinical outcomes or isokinetic performance.The clinical relevance of this study is that the potential differences in clinical outcomes and isokinetic performance between UC and PS inserts do not need to be considered when sacrificing the PCL in TKA.
LEVEL OF EVIDENCE


I.",2020,"Gradual improvement in the KSS was observed in both groups, but no significant differences were detected between the groups during the whole follow-up period.","['posterior cruciate ligament (PCL)-sacrificing total knee arthroplasty (TKA', 'Sixty-six patients diagnosed with primary knee osteoarthritis']","['cruciate-substituting ultra-congruent and posterior stabilized total knee arthroplasties', 'ultra-congruent (UC) or posterior cruciate ligament-stabilized (PS', 'UC']","['peak extension and flexion torque values normalized to body weight', 'KSS', 'isokinetic performance and clinical outcomes', 'Knee Society score (KSS) and isokinetic performance results', 'clinical outcomes or isokinetic performance', 'preoperative KSS or isokinetic performance']","[{'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",66.0,0.0471752,"Gradual improvement in the KSS was observed in both groups, but no significant differences were detected between the groups during the whole follow-up period.","[{'ForeName': 'Sefa', 'Initials': 'S', 'LastName': 'Akti', 'Affiliation': 'Department of Orthopaedic and Traumatology, Aksaray University Education and Research Hospital, Tacin Street, 68120, Aksaray, Turkey. sefa.akti@gmail.com.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Karakus', 'Affiliation': 'Department of Physical Medicine and Rehabilition, Ankara City Hospital, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Erdem Aras', 'Initials': 'EA', 'LastName': 'Sezgin', 'Affiliation': 'Department of Orthopaedic and Traumatology, Aksaray University Education and Research Hospital, Tacin Street, 68120, Aksaray, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Cankaya', 'Affiliation': 'Department of Orthopaedic and Traumatology, Aksaray University Education and Research Hospital, Tacin Street, 68120, Aksaray, Turkey.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06275-z']
2966,32940745,[Evaluation of an early interdisciplinary multimodal assessment for patients with pain : Protocol of a randomized controlled study (PAIN2020)].,"Health care provision for patients with pain and risk factors for chronicity is still insufficient and characterized in particular by over-, under- and misuse of existing approaches. The PAIN2020 project is funded by the German Federal Ministry of Health Care (Innovationsfonds 01NVF17049) and aims to improve health care delivery for this group of patients by implementing an early ambulatory diagnostic approach by a pain specialist, resulting in an improvement in pain and restored or maintained function. A randomized clinical trial in 31 facilities Germany-wide will identify eligible patients and guide them into early specialized pain diagnostics. The interventional arm provides an interdisciplinary multimodal assessment, delivered by pain medicine specialists, physiotherapists and clinical psychologists. The control arm contains a single assessment by a pain specialist. Patients and caregivers receive detailed recommendations for evidence-based interventions tailored to the needs of the individual patient. Two evaluation approaches will be merged. The first requires a net sample size of 3840 patients, assessed (admission) and followed-up (3 and 6 months) by clinical data (German Pain Questionnaire, additional scales) and analyzed by a multi-level approach. In a second evaluation arm the clinical data of the included patients will be supplemented by secondary data from a statutory health insurance (BARMER) and compared to a sample of policyholders not addressed by the study. Data analyses will be performed by an external evaluation institute. The project started in April 2018.",2020,"Health care provision for patients with pain and risk factors for chronicity is still insufficient and characterized in particular by over-, under- and misuse of existing approaches.","['3840 patients, assessed (admission) and followed-up (3 and 6\xa0months) by clinical data (German Pain Questionnaire, additional scales) and analyzed by a\xa0multi-level approach', '31\xa0facilities Germany-wide will identify eligible patients and guide them into early specialized pain diagnostics', 'patients with pain ', 'patients with pain and risk factors']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",[],[],3840.0,0.0929455,"Health care provision for patients with pain and risk factors for chronicity is still insufficient and characterized in particular by over-, under- and misuse of existing approaches.","[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Kaiser', 'Affiliation': 'Medizinische Fakultät und Universitäts\xa0SchmerzCentrum, Universitätsklinik Carl Gustav Carus Dresden, Fetscherstraße\xa074, 01307, Dresden, Deutschland. ulrike.kaiser.usc-tkl@uniklinikum-dresden.de.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Petzke', 'Affiliation': 'Universitätsmedizin Göttingen, Schmerzmedizin, Klinik für Anästhesiologie, Universitätsmedizin Göttingen, Robert-Koch-Str.\xa040, 37075, Göttingen, Deutschland.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Nagel', 'Affiliation': 'Ambulanz, Tagesklinik, Stationäre Behandlung, DRK Schmerz-Zentrum Mainz, Auf der Steig\xa016, 55131, Mainz, Deutschland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Marschall', 'Affiliation': 'Abteilung Medizin und Versorgungsforschung, BARMER, Lichtscheider Straße\xa089, 42285, Wuppertal, Deutschland.'}, {'ForeName': 'Hans-Raimund', 'Initials': 'HR', 'LastName': 'Casser', 'Affiliation': 'Ambulanz, Tagesklinik, Stationäre Behandlung, DRK Schmerz-Zentrum Mainz, Auf der Steig\xa016, 55131, Mainz, Deutschland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Isenberg', 'Affiliation': 'Deutsche Schmerzgesellschaft e.\u202fV., Alt-Moabit 101b, 10559, Berlin, Deutschland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kohlmann', 'Affiliation': 'Abteilung Methoden der Community Medicine, Institut für Community Medicine, Universitätsmedizin Greifswald, Walther-Rathenau-Str.\xa048, 17475, Greifswald, Deutschland.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Lindena', 'Affiliation': 'Deutsche Schmerzgesellschaft e.\u202fV., Alt-Moabit 101b, 10559, Berlin, Deutschland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Schmerz (Berlin, Germany)",['10.1007/s00482-020-00497-3']
2967,32940750,Short and long-arm fiberglass cast immobilization for displaced distal forearm fractures in children: a randomized controlled trial.,"PURPOSE


The aim of this study was to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced distal forearm fractures after closed reduction in paediatric patients.
METHODS


A prospective, randomized, controlled trial of children aged four to 16 years (mean 9.9 years) was designed with a sample of 120 children, whose size was set a priori, with 60 treated with SAC and 60 with LAC. The primary outcome was fracture stability and rate of loss of reduction. The secondary outcome analysis evaluated duration of analgesic therapy, restriction in activities of daily life, and the duration until patients regained normal range of motion in the elbow.
RESULTS


No statistically significant differences were found between the two groups in loss of reduction or duration of analgesic therapy. In contrast, the duration until normal range of motion in the elbow was regained was significantly longer in the LAC group (median 4.5 days, P < 0.001). Restriction in activities of daily life did not differ significantly between the two groups except for the item ""help needed with showering in the first days after trauma"" (SAC 60%, LAC 87%, P = 0.001).
CONCLUSION


Fracture immobilization with short-arm fiberglass cast in reduced distal forearm fractures is not inferior to long-arm casts in children four years and older, excluding completely displaced fractures. Furthermore, short-arm casting reduces the need for assistance during showering.
TRIAL REGISTRATION


NCT03297047, September 29, 2017.",2020,"Restriction in activities of daily life did not differ significantly between the two groups except for the item ""help needed with showering in the first days after trauma"" (SAC 60%, LAC 87%, P = 0.001).
","['children aged four to\xa016\xa0years (mean 9.9\xa0years) was designed with a sample of 120 children, whose size was set a priori, with 60 treated with SAC and 60 with LAC', 'displaced distal forearm fractures in children', 'paediatric patients']","['LAC', 'Short and long-arm fiberglass cast immobilization', 'long-arm cast (LAC', 'Fracture immobilization with short-arm fiberglass cast', 'short-arm fiberglass cast (SAC) immobilization']","['Restriction in activities of daily life', 'loss of reduction or duration of analgesic therapy', 'fracture stability and rate of loss of reduction', 'duration of analgesic therapy, restriction in activities of daily life, and the duration until patients regained normal range of motion in the elbow', 'distal forearm fractures', 'duration until normal range of motion in the elbow']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0575519', 'cui_str': 'Long upper limb'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1305215', 'cui_str': 'Fracture of forearm'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0575519', 'cui_str': 'Long upper limb'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0559871', 'cui_str': 'Fracture stability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1305215', 'cui_str': 'Fracture of forearm'}]",120.0,0.145509,"Restriction in activities of daily life did not differ significantly between the two groups except for the item ""help needed with showering in the first days after trauma"" (SAC 60%, LAC 87%, P = 0.001).
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Seiler', 'Affiliation': ""Pediatric Emergency Department, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032, Zurich, Switzerland. michelle.seiler@kispi.uzh.ch.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Heinz', 'Affiliation': ""Children's Research Center, University Children's Hospital Zurich, University of Zurich, Zurich, Switzerland.""}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Callegari', 'Affiliation': ""Pediatric Emergency Department, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032, Zurich, Switzerland.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dreher', 'Affiliation': ""Children's Research Center, University Children's Hospital Zurich, University of Zurich, Zurich, Switzerland.""}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Staubli', 'Affiliation': ""Pediatric Emergency Department, University Children's Hospital Zurich, Steinwiesstrasse 75, 8032, Zurich, Switzerland.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Aufdenblatten', 'Affiliation': ""Children's Research Center, University Children's Hospital Zurich, University of Zurich, Zurich, Switzerland.""}]",International orthopaedics,['10.1007/s00264-020-04800-w']
2968,32940823,"Effects of an Inclusive Physical Activity Program on the Motor Skills, Social Skills and Attitudes of Students with and without Autism Spectrum Disorder.","This study investigated the effects of an inclusive physical activity (IPA) program on the motor and social skills and attitudes of students with and without autism spectrum disorder (ASD). The study sample consisted of 45 ASD and typical development (TD) students aged between 6 and 11 years. The students were randomly divided into two groups: a training group consisting of 27 students (n = 13 with ASD and n = 14 with TD) and a control group consisting of 18 students (n = 9 with ASD and n = 9 with TD). In conclusion, the IPA program increased the motor and social skills of the ASD students and improved the motor skills of the TD students and positively affected their attitudes towards the ASD students.",2020,"In conclusion, the IPA program increased the motor and social skills of the ASD students and improved the motor skills of the TD students and positively affected their attitudes towards the ASD students.","['Students with and without Autism Spectrum Disorder', 'students with and without autism spectrum disorder (ASD', '45 ASD and typical development (TD) students aged between 6 and 11\xa0years']","['inclusive physical activity (IPA) program', 'control group consisting of 18 students (n\u2009=\u20099 with ASD and n\u2009=\u20099 with TD', 'training group consisting of 27 students (n\u2009=\u200913 with ASD and n\u2009=\u200914 with TD', 'Inclusive Physical Activity Program', 'IPA program']","['motor skills', 'Motor Skills, Social Skills and Attitudes', 'motor and social skills']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",45.0,0.0146755,"In conclusion, the IPA program increased the motor and social skills of the ASD students and improved the motor skills of the TD students and positively affected their attitudes towards the ASD students.","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Sansi', 'Affiliation': 'Vocational School of Health Services, Batman University, Batman, Turkey. ahmetsansi72@hotmail.com.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Nalbant', 'Affiliation': 'Faculty of Sport Sciences, Alanya Alaaddin Keykubat University, Antalya, Turkey.'}, {'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Ozer', 'Affiliation': 'Faculty of Health Sciences, İstanbul Kent University, İstanbul, Turkey.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04693-z']
2969,32940847,Anthracycline-induced cardiotoxicity in patients with early-stage breast cancer: the Canadian Cancer Trials Group (CCTG) MA.21 experience.,"PURPOSE


Anthracyclines are frequently used in adjuvant treatment for early-stage breast cancer (ESBC). The purpose of this study was to evaluate cardiotoxic effects in the first five years after treatment with different anthracycline-based regimens.
METHODS


CCTG MA.21 (NCT000142) was a phase III trial in ESBC that compared cyclophosphamide (75 mg/m 2 ) orally for 14 days, epirubicin (60 mg/m 2 ) and fluorouracil, IV days one and eight (CEF) for six cycles; dose-dense epirubicin (120 mg/m 2 ) and cyclophosphamide, IV every 2 weeks for six cycles with concurrent G-CSF then paclitaxel every 2 weeks for four cycles (ddEC/T); doxorubicin (60 mg/m 2 ) and cyclophosphamide (600 mg/m 2 ) every 3 weeks for four cycles then four cycles q3 weekly paclitaxel (175 mg/m 2 ) (AC/T).
ENDPOINTS


LVEF decline; LV function changes (heart failure), or Grade 3-4 cardiac ischemia/infarction. A competing risk analysis was performed with endpoints of cardiotoxicity or recurrence in first 5 years after completion of chemotherapy.
RESULTS


2104 women were randomized. Compliance with cardiac LVEF assessments was 70% at 5 years in all arms. The 5-year cumulative risks of any cardiac event for CEF, ddECT, and AC/T were 22.3% (95%CI 18.9 to 25.7), 14.2% (95%CI 11.0 to 17.3), and 8.1% (95%CI 5.8 to 10.4), respectively, p < 0.0001. At 5 years, women in the ddEC/T and AC/T group had significantly lower risk of cardiotoxicity than those given CEF (HR 0.599 and 0.371, respectively). Most events were asymptomatic drop in LVEF.
CONCLUSIONS


Asymptomatic changes in LVEF accounted for most of the cardiotoxicity. The majority of cardiac events occurred in year one although occurrence of cardiotoxicity over time highlights the need for improved risk stratification to guide cardiac surveillance strategies.",2020,"At 5 years, women in the ddEC/T and AC/T group had significantly lower risk of cardiotoxicity than those given CEF (HR 0.599 and 0.371, respectively).","['patients with early-stage breast cancer', '2104 women were randomized', 'early-stage breast cancer (ESBC']","['cyclophosphamide', 'fluorouracil, IV days one and eight (CEF) for six cycles; dose-dense epirubicin', 'Anthracycline-induced cardiotoxicity', 'paclitaxel', 'doxorubicin', 'epirubicin', 'cyclophosphamide, IV every 2\xa0weeks for six cycles with concurrent G-CSF', 'anthracycline-based regimens']","['LVEF decline; LV function changes (heart failure), or Grade 3-4 cardiac ischemia/infarction', '5-year cumulative risks of any cardiac event for CEF, ddECT, and AC/T', 'risk of cardiotoxicity', 'Compliance with cardiac LVEF assessments', 'cardiotoxicity or recurrence', 'cardiotoxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0248241', 'cui_str': 'CEF regimen'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",2104.0,0.0494486,"At 5 years, women in the ddEC/T and AC/T group had significantly lower risk of cardiotoxicity than those given CEF (HR 0.599 and 0.371, respectively).","[{'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Dent', 'Affiliation': 'Division of Medical Oncology, Duke Cancer Institute, 10 Brian Searle Drive, Seeley G Mudd Bldg Room 455, Durham, NC, 27710, USA. Susan.dent@duke.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Botros', 'Affiliation': 'Division of Medical Oncology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rushton', 'Affiliation': 'Division of Medical Oncology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Aseyev', 'Affiliation': 'Division of Medical Oncology, Thunder Bay Regional Health Sciences, Thunder Bay, ON, Canada.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Levine', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'W R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': 'Canadian Cancer Trials Group (CCTG), Queens University, Kingston, ON, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""O'Brien"", 'Affiliation': 'Canadian Cancer Trials Group (CCTG), Queens University, Kingston, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Burnell', 'Affiliation': 'Department of Oncology, Saint John Regional Hospital, Saint John, New Brunswick, Canada.'}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Division of Medical Oncology/Hematology, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': 'Canadian Cancer Trials Group (CCTG), Queens University, Kingston, ON, Canada.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': 'Canadian Cancer Trials Group (CCTG), Queens University, Kingston, ON, Canada.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05887-w']
2970,32940857,"Project STRONG: an Online, Parent-Son Intervention for the Prevention of Dating Violence among Early Adolescent Boys.","Despite broad calls for prevention programs to reduce adolescent dating violence (DV), there is a dearth of programs designed specifically for males. In fact, there are no programs that capitalize on the importance of parents in modeling and influencing the choices their sons make in future romantic relationships. To address these gaps, this study assessed the initial feasibility, acceptability, and efficacy of an online, parent-son intervention (STRONG) aimed at reducing DV among early adolescent males. One-hundred nineteen 7th- and 8th-grade boys were recruited, with a parent (90% mothers), from six urban middle schools in the Providence, RI area. Dyads were randomized to either STRONG or a waitlist comparison group. STRONG targets three primary constructs: relationship health knowledge, emotion regulation, and communication. Families randomized to the waitlist were nearly twice as likely at 3 months (OR = 1.92 [0.43-8.60]) and nearly 7 times as likely at 9 months (OR = 6.76 [0.66-69.59]) to endorse any form of DV perpetration (physical, sexual, verbal/emotional) when compared with STRONG families. STRONG also had positive effects on teens' attitudes toward dealing with DV, their emotional awareness, and their short-term regulation skills and was associated with increased discussion of critical relationship topics. Pilot outcomes indicate that an online DV prevention program designed to engage early adolescent boys and parents is both acceptable and engaging. Findings show promise for reducing DV behaviors and theory-driven mediators. ClinicalTrials.gov Identifier: NCT03109184.",2020,"Families randomized to the waitlist were nearly twice as likely at 3 months (OR = 1.92 [0.43-8.60]) and nearly 7 times as likely at 9 months (OR = 6.76 [0.66-69.59]) to endorse any form of DV perpetration (physical, sexual, verbal/emotional) when compared with STRONG families.","['One-hundred nineteen 7th- and 8th-grade boys were recruited, with a parent (90% mothers), from six urban middle schools in the Providence, RI area', 'Early Adolescent Boys', 'early adolescent males']","['Online, Parent-Son Intervention', 'online DV prevention program']","['relationship health knowledge, emotion regulation, and communication', 'initial feasibility, acceptability, and efficacy', 'DV behaviors']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037683', 'cui_str': 'Son'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0280442,"Families randomized to the waitlist were nearly twice as likely at 3 months (OR = 1.92 [0.43-8.60]) and nearly 7 times as likely at 9 months (OR = 6.76 [0.66-69.59]) to endorse any form of DV perpetration (physical, sexual, verbal/emotional) when compared with STRONG families.","[{'ForeName': 'Christie J', 'Initials': 'CJ', 'LastName': 'Rizzo', 'Affiliation': 'Department of Applied Psychology, Bouvé College of Health Sciences, Northeastern University, 432 INV, 360 Huntington Ave., Boston, MA, 02115-5000, USA. c.rizzo@northeastern.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Houck', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barker', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Collibee', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hood', 'Affiliation': 'Department of Applied Psychology, Bouvé College of Health Sciences, Northeastern University, 432 INV, 360 Huntington Ave., Boston, MA, 02115-5000, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Bala', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI, USA.""}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01168-6']
2971,32078484,Benefit of Targeting a LDL (Low-Density Lipoprotein) Cholesterol <70 mg/dL During 5 Years After Ischemic Stroke.,"Background and Purpose- The TST trial (Treat Stroke to Target) evaluated the benefit of targeting a LDL (low-density lipoprotein) cholesterol of <70 mg/dL to reduce the risk of cardiovascular events in 2860 patients with ischemic stroke with atherosclerotic stenosis of cerebral vasculature or aortic arch plaque >4 mm, in a French and Korean population. The follow-up lasted a median of 5.3 years in French patients (similar to the median follow-up time in the SPARCL trial [Stroke Prevention by Aggressive Reduction in Cholesterol Level]) and 2.0 years in Korean patients. Exposure duration to statin is a well-known driver for cardiovascular risk reduction. We report here the TST results in the French cohort. Methods- One thousand seventy-three French patients were assigned to <70 mg/dL (1.8 mmol/L) and 1075 to 100±10 mg/dL (90-110 mg/dL, 2.3-2.8 mmol/L). To achieve these goals, investigators used the statin and dosage of their choice and added ezetimibe on top if needed. The primary outcome was the composite of ischemic stroke, myocardial infarction, new symptoms requiring urgent coronary or carotid revascularization and vascular death. Results- After a median follow-up of 5.3 years, the achieved LDL cholesterol was 66 (1.69 mmol/L) and 96 mg/dL (2.46 mmol/L) on average, respectively. The primary end point occurred in 9.6% and 12.9% of patients, respectively (HR, 0.74 [95% CI, 0.57-0.94];  P =0.019). Cerebral infarction or urgent carotid revascularization following transient ischemic attack was reduced by 27% ( P =0.046). Cerebral infarction or intracranial hemorrhage was reduced by 28% ( P =0.023). The primary outcome or intracranial hemorrhage was reduced by 25% ( P =0.021). Intracranial hemorrhages occurred in 13 and 11 patients, respectively (HR, 1.17 [95% CI, 0.53-2.62];  P =0.70). Conclusions- After an ischemic stroke of documented atherosclerotic origin, targeting a LDL cholesterol of <70 mg/dL during 5.3 years avoided 1 subsequent major vascular event in 4 (number needed to treat of 30) and no increase in intracranial hemorrhage. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01252875.",2020,Cerebral infarction or urgent carotid revascularization following transient ischemic attack was reduced by 27% ( P =0.046).,"['One thousand seventy-three French patients', '2860 patients with ischemic stroke with atherosclerotic stenosis of cerebral vasculature or aortic arch plaque >4 mm, in a French and Korean population']","['ezetimibe', 'Conclusions', ' and Purpose', 'Methods', 'LDL (Low-Density Lipoprotein) Cholesterol <70 mg/dL']","['composite of ischemic stroke, myocardial infarction, new symptoms requiring urgent coronary or carotid revascularization and vascular death', 'intracranial hemorrhage', 'Intracranial hemorrhages', 'LDL cholesterol', 'Cerebral infarction or intracranial hemorrhage', 'Cerebral infarction or urgent carotid revascularization following transient ischemic attack']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0003489', 'cui_str': 'Aortic arch structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C3495793', 'cui_str': 'Carotid revascularisation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]",2860.0,0.276558,Cerebral infarction or urgent carotid revascularization following transient ischemic attack was reduced by 27% ( P =0.046).,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'From the APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, France (P.A., J.L., H.C.).'}, {'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea (J.S.K.).'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'From the APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, France (P.A., J.L., H.C.).'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Charles', 'Affiliation': 'From the APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, France (P.A., J.L., H.C.).'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Giroud', 'Affiliation': 'Department of Neurology, University Hospital of Dijon, University of Burgundy, France (M.G.).'}, {'ForeName': 'Byung-Chul', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Hallym University Sacred Heart Hospital, Anyang, Korea (B.-C.L.).'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mahagne', 'Affiliation': 'Stroke Unit, Pasteur Hospital, Nice, France (M.-H.M.).'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': 'Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, France (N.N.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gabriel Steg', 'Affiliation': 'APHP, Department of cardiology, INSERM LVTS-U1148, DHU FIRE, University of Paris, Hôpital Bichat, France (P.G.S.).'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Vicaut', 'Affiliation': 'NHLI Imperial College, ICMS Royal Brompton Hospital London, United Kingdom (P.G.S.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': 'APHP, Department of Endocrinology, Pitié-Salpêtrière hospital, Sorbonne University, Paris, France (E.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028718']
2972,32156204,Effect of Steady and Dynamic Blood Pressure Parameters During Thrombectomy According to the Collateral Status.,"Background and Purpose- Guidelines regarding blood pressure (BP) management during endovascular therapy (EVT) for anterior circulation strokes are questionable since the optimal BP target is a matter of debate. To evaluate the importance of hemodynamic control during EVT, we investigated the impact of dynamic and steady BP parameters during EVT on functional outcome (part 1) and according to the collateral status (CS; part 2). Methods- We performed a post hoc analysis of the ASTER trial (Contact Aspiration Versus Stent Retriever for Successful Recanalization). BP was measured noninvasively during EVT and CS assessed on the angiographic run before EVT. We studied dynamic BP parameter using BP variability (coefficient of variation) and steady BP parameter (hypotension time defined as systolic BP <140 mm Hg and mean arterial pressure <90 mm Hg). The primary outcome was favorable outcome defined as a 3-month modified Rankin Scale score between 0 and 2. Results- Among the 381 patients of the ASTER study, 172 patients were included in part 1 and 159 in part 2. Systolic BP, diastolic BP, and mean arterial pressure variability were negatively associated with favorable outcome regardless of CS: per 10-unit increase, adjusted odds ratios were 0.45 (95% CI, 0.20-0.98), 0.37 (95% CI, 0.19-0.72), and 0.35 (95% CI, 0.16-0.76), respectively. According to CS, the hypotension time with periprocedural mean arterial pressure <90 mm Hg was negatively associated with favorable outcome in patients with poor CS (adjusted odds ratio, 0.88 [95% CI, 0.72-1.09]) but not in patients with good CS (adjusted odds ratio, 1.24 [95% CI, 0.91-1.67];  P het =0.047). Conclusions- The CS did not modify the association between dynamic parameters and functional outcomes, but some findings suggest that the CS modifies the association between steady parameter and functional outcomes. Hypotension time according to the CS was not statistically predictive of poor outcomes but displayed a trend toward worse outcomes for patients with poor CS only.",2020,Hypotension time according to the CS was not statistically predictive of poor outcomes but displayed a trend toward worse outcomes for patients with poor CS only.,"['381 patients of the ASTER study, 172 patients were included in part 1 and 159 in part 2']","['Conclusions', 'Methods', ' and Purpose- Guidelines regarding blood pressure (BP) management during endovascular therapy (EVT', 'Thrombectomy', 'Steady and Dynamic Blood Pressure Parameters']","['hypotension time with periprocedural mean arterial pressure', 'Hypotension time', 'BP variability (coefficient of variation) and steady BP parameter (hypotension time defined as systolic BP', '3-month modified Rankin Scale score between 0 and 2. Results', 'Systolic BP, diastolic BP, and mean arterial pressure variability', 'BP']","[{'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0331312', 'cui_str': 'Aster'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",172.0,0.0737804,Hypotension time according to the CS was not statistically predictive of poor outcomes but displayed a trend toward worse outcomes for patients with poor CS only.,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Maïer', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Dargazanli', 'Affiliation': 'Diagnostic and Interventional Neuroradiology Department, Guy de Chauliac Hospital, Montpellier, France (C.D.).'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Bourcier', 'Affiliation': 'Interventional Neuroradiology Department (R.B.), Nantes Hospital, France.'}, {'ForeName': 'Maëva', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'CHU Lille, EA 2694 Santé publique: épidémiologie et qualité des soins, University of Lille, France (M.K., J.L.).'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'CHU Lille, EA 2694 Santé publique: épidémiologie et qualité des soins, University of Lille, France (M.K., J.L.).'}, {'ForeName': 'Pascal J', 'Initials': 'PJ', 'LastName': 'Mosimann', 'Affiliation': 'Diagnostic and Interventional Neuroradiology Department, Bern University Hospital, Switzerland (P.J.M.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Puccinelli', 'Affiliation': 'Diagnostic and Interventional Neuroradiology Department, Lausanne Hospital, Switzerland (F.P.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'Intensive Care Unit Department, Fondation Rothschild, Paris, France (G.T.).'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Intensive Care Unit Department (M.L.G.), Foch Hospital, Suresnes, France.'}, {'ForeName': 'Romuald', 'Initials': 'R', 'LastName': 'Riem', 'Affiliation': 'Intensive Care Unit Department (R.R.), Nantes Hospital, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Desilles', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Boisseau', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fahed', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Hocine', 'Initials': 'H', 'LastName': 'Redjem', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Smajda', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ciccio', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Escalard', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': 'Betrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Stroke Center (B.L.), Foch Hospital, Suresnes, France.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'From the Interventional Neuroradiology Department, Fondation Rothschild, Paris, France (B.M., J.-P.D., W.B., R.F., H.R., S.S., G.C., S.E., R.B., M.P., M.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.026769']
2973,32456396,Obstructive left side colon cancer: time for a tailored operative approach?,"BACKGROUND


Colorectal cancer (CRC) obstruction is frequent but doubts remain on the best treatment. The aim of this study is to analyze the different operative approach used for CRC treatment and evaluate the outcomes for the different cases.
METHODS


Patients were collected from January 2014 to December 2019 and divided in four groups: two ""P"" groups, namely the Hartmann's procedure (PH) group and the primary anastomosis (PA) group, and two ""S"" groups, namely the deviating stoma (SD) group and the self-expanding metallic stent (SS) group. The main endpoints were the quality of life and the oncologic safety.
RESULTS


One hundred and eight patients were enrolled. The mean follow-up time was 39 months. The stomas were performed less frequently in SS but lasted more in that group. Only 45% underwent reversal surgery. Cumulative operating time was greater in S versus P groups. The rate of major complications was similar. PA had greater overall survival and disease-free survival rates than PH.
CONCLUSIONS


The various options of treatment should have different indications: primary anastomosis in stable patients, Hartmann in critical cases, SEMS for palliative intent and stoma when neo-adjuvant therapy is needed.",2020,PA had greater overall survival and disease-free survival rates than PH,"['One hundred and eight patients were enrolled', 'Patients were collected from January 2014 to December 2019 and divided in four groups', 'Obstructive left side colon cancer']","['two ""P"" groups, namely the Hartmann\'s procedure (PH) group and the primary anastomosis (PA) group, and two ""S"" groups, namely the deviating stoma (SD) group and the self-expanding metallic stent (SS', 'PH']","['rate of major complications', 'overall survival and disease-free survival rates', 'quality of life and the oncologic safety', 'Cumulative operating time']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",108.0,0.0247041,PA had greater overall survival and disease-free survival rates than PH,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Bergamini', 'Affiliation': 'Unit of Emergency Surgery, Department of Emergency, Careggi University Hospital, Florence, Italy - drcarlobergamini@gmail.com.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': 'Unit of Emergency Surgery, Department of Emergency, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Gherardo', 'Initials': 'G', 'LastName': 'Maltinti', 'Affiliation': 'Unit of Emergency Surgery, Department of Emergency, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Alemanno', 'Affiliation': 'Unit of Emergency Surgery, Department of Emergency, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Cianchi', 'Affiliation': 'Department of Emergency, Unit of General and Endocrine Surgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Coratti', 'Affiliation': 'Department of Robotic Oncologic Surgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Manetti', 'Affiliation': 'Unit of Operative Endoscopy, Department of Robotic Oncologic Surgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Valeri', 'Affiliation': 'Unit of Emergency Surgery, Department of Emergency, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Prosperi', 'Affiliation': 'Unit of Emergency Surgery, Department of Emergency, Careggi University Hospital, Florence, Italy.'}]",Minerva chirurgica,['10.23736/S0026-4733.20.08299-1']
2974,32939557,Partial Replacement of Animal Proteins with Plant Proteins for 12 Weeks Accelerates Bone Turnover Among Healthy Adults: A Randomized Clinical Trial.,"BACKGROUND


Plant-based diets may reduce the risk of chronic diseases, but can also lead to low calcium and vitamin D intakes, posing a risk for bone health.
OBJECTIVES


We investigated whether partial replacement of animal proteins with plant-based proteins using a whole-diet approach affects bone and mineral metabolism in healthy adults in 3 groups fed diets differing in protein composition.
METHODS


This 12-week clinical trial was comprised of 107 women and 29 men (20-69 years old; BMI mean ± SD, 24.8 ± 3.9) randomly assigned to consume 1 of 3 diets designed to provide 17 energy percent (E%) protein: ""animal"" (70% animal protein, 30% plant protein of total protein intake), ""50/50"" (50% animal, 50% plant), and ""plant"" (30% animal, 70% plant) diets. We examined differences in bone formation [serum intact procollagen type I amino-terminal propeptide (S-iPINP)], bone resorption [serum collagen type 1 cross-linked C-terminal telopeptide (S-CTX)], mineral metabolism markers (primary outcomes), and nutrient intakes (secondary outcomes) by ANOVA/ANCOVA.
RESULTS


S-CTX was significantly higher in the plant group (mean ± SEM, 0.44 ± 0.02 ng/mL) than in the other groups (P values < 0.001 for both), and differed also between the animal (mean ± SEM, 0.29 ± 0.02 ng/mL) and 50/50 groups (mean ± SEM, 0.34 ± 0.02 ng/mL; P = 0.018). S-iPINP was significantly higher in the plant group (mean ± SEM, 63.9 ± 1.91 ng/mL) than in the animal group (mean ± SEM, 55.0 ± 1.82 ng/mL; P = 0.006). In a subgroup without a history of vitamin D supplement use, plasma parathyroid hormone was significantly higher in the plant than in the animal group (P = 0.018). Vitamin D and calcium intakes were below recommended levels in the plant group (mean ± SEM, 6.2 ± 3.7 μg/d and 733 ± 164 mg/d, respectively).
CONCLUSIONS


Partial replacement of animal proteins with plant-based proteins for 12 weeks increased the markers of bone resorption and formation among healthy adults, indicating a possible risk for bone health. This is probably caused by lower vitamin D and calcium intakes from diets containing more plant-based proteins, but it is unclear whether differences in protein intake or quality play a major role. This trial was registered at clinicaltrials.gov as NCT03206827.",2020,"Vitamin D and calcium intakes were below recommended levels in the plant group (mean ± SEM, 6.2 ± 3.7 μg/d","['and\xa0733\xa0±\xa0164', 'Healthy Adults', 'healthy adults', 'healthy adults in 3 groups fed diets differing in protein composition', '107 women and 29 men (20-69 years old; BMI mean\xa0±\xa0SD, 24.8\xa0±\xa03.9)\xa0randomly assigned to']","['Partial Replacement of Animal Proteins with Plant Proteins', 'partial replacement of animal proteins with plant-based proteins using a whole-diet approach', 'consume 1 of 3 diets designed to provide 17 energy percent (E%) protein: ""animal"" (70% animal protein, 30% plant protein of total protein intake), ""50/50"" (50% animal, 50% plant), and ""plant"" (30% animal, 70% plant) diets']","['bone formation [serum intact procollagen type', 'Vitamin D and calcium intakes', 'plasma parathyroid hormone', 'bone resorption and formation', 'iPINP']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0440447', 'cui_str': 'Animal protein'}, {'cui': 'C0032089', 'cui_str': 'Plant Proteins'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0857707', 'cui_str': 'Plasma parathyroid hormone'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.160611,"Vitamin D and calcium intakes were below recommended levels in the plant group (mean ± SEM, 6.2 ± 3.7 μg/d","[{'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Itkonen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Päivärinta', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Pellinen', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Viitakangas', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Risteli', 'Affiliation': 'Cancer and Translational Medicine Research Unit, Department of Clinical Chemistry, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maijaliisa', 'Initials': 'M', 'LastName': 'Erkkola', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Lamberg-Allardt', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anne-Maria', 'Initials': 'AM', 'LastName': 'Pajari', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}]",The Journal of nutrition,['10.1093/jn/nxaa264']
2975,32944934,Long-term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open-label extension study.,"OBJECTIVE


To assess the efficacy, safety, and tolerability of eslicarbazepine acetate (ESL) monotherapy during long-term treatment.
METHODS


An open-label extension (OLE) study was conducted in adults completing a phase 3, randomized, double-blind, noninferiority trial, during which they had received monotherapy with either once-daily ESL or twice-daily controlled-release carbamazepine (CBZ-CR) for newly diagnosed focal epilepsy. In the OLE study, all patients received ESL (800-1600 mg/d) for 2 years. Primary efficacy outcome was retention time (from baseline of the OLE study). Secondary efficacy assessments included seizure freedom rate (no seizures during the OLE study) and responder rate (≥50% seizure frequency reduction from baseline of double-blind trial). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs).
RESULTS


Of 206 randomized patients, 96 who received ESL in the double-blind trial (ESL/ESL) and 88 who received CBZ-CR in the double-blind trial (CBZ-CR/ESL) were treated with ESL monotherapy (89.3% overall). Treatment retention time was similar between groups, with low probability of ESL withdrawal overall (<0.07 at any time). After 24 months, the probability of ESL withdrawal was 0.0638 (95% confidence interval [CI] = 0.0292-0.1366) in the ESL/ESL group and 0.0472 (95% CI = 0.0180-0.1210) in the CBZ-CR/ESL group. Seizure freedom rates were 90.6% (ESL/ESL) and 80.7% (CBZ-CR/ESL; P = .0531). Responder rates remained >80% in both groups throughout the study. Incidence of serious TEAEs was similar between groups (7.3% vs 5.7%; 0% vs 1.1% possibly related), as were the incidences of TEAEs considered at least possibly related to treatment (17.7% vs 18.2%) and TEAEs leading to discontinuation (3.1% vs 4.5%). The types of TEAEs were generally consistent with the known safety profile of ESL.
SIGNIFICANCE


ESL monotherapy was efficacious and generally well tolerated over the long term, including in patients who transitioned from CBZ-CR monotherapy. No new safety concerns emerged.",2020,"Treatment retention time was similar between groups, with low probability of ESL withdrawal overall (<0.07 at any time).","['206 randomized patients, 96 who received', 'adults with newly diagnosed focal epilepsy']","['ESL', 'eslicarbazepine acetate monotherapy', 'OLE', 'CBZ-CR', 'ESL monotherapy', 'eslicarbazepine acetate (ESL) monotherapy', 'monotherapy with either once-daily ESL or twice-daily controlled-release carbamazepine (CBZ-CR']","['Seizure freedom rates', 'Treatment retention time', 'efficacy, safety, and tolerability', 'probability of ESL withdrawal', 'evaluation of treatment-emergent adverse events (TEAEs', 'retention time', 'Responder rates', 'Incidence of serious TEAEs', 'seizure freedom rate (no seizures during the OLE study) and responder rate', 'ESL withdrawal overall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",206.0,0.719132,"Treatment retention time was similar between groups, with low probability of ESL withdrawal overall (<0.07 at any time).","[{'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Trinka', 'Affiliation': 'Department of Neurology, Centre for Cognitive Neuroscience, Christian-Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Rocamora', 'Affiliation': 'Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Chaves', 'Affiliation': 'University Hospital Center of Porto, S. António Hospital, Porto, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Moreira', 'Affiliation': 'Bial-Portela & Cª, S.A., Coronado, Portugal.'}, {'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Ikedo', 'Affiliation': 'Bial-Portela & Cª, S.A., Coronado, Portugal.'}, {'ForeName': 'Patrício', 'Initials': 'P', 'LastName': 'Soares-da-Silva', 'Affiliation': 'Bial-Portela & Cª, S.A., Coronado, Portugal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epilepsia,['10.1111/epi.16666']
2976,32944940,Treatments for breast engorgement during lactation.,"BACKGROUND


Engorgement is the overfilling of breasts with milk, often occurring in the early days postpartum. It results in swollen, hard, painful breasts and may lead to premature cessation of breastfeeding, decreased milk production, cracked nipples and mastitis. Various treatments have been studied but little consistent evidence has been found on effective interventions.
OBJECTIVES


To determine the effectiveness and safety of different treatments for engorgement in breastfeeding women.
SEARCH METHODS


On 2 October 2019, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies.
SELECTION CRITERIA


All types of randomised controlled trials and all forms of treatment for breast engorgement were eligible.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed trials for eligibility, extracted data, conducted 'Risk of bias' assessment and assessed the certainty of evidence using GRADE.
MAIN RESULTS


For this udpate, we included 21 studies (2170 women randomised) conducted in a variety of settings. Six studies used individual breasts as the unit of analysis. Trials examined a range of interventions: cabbage leaves, various herbal compresses (ginger, cactus and aloe, hollyhock), massage (manual, electromechanical, Oketani), acupuncture, ultrasound, acupressure, scraping therapy, cold packs, and medical treatments (serrapeptase, protease, oxytocin). Due to heterogeneity, meta-analysis was not possible and data were reported from single trials. Certainty of evidence was downgraded for limitations in study design, imprecision and for inconsistency of effects. We report here findings from key comparisons. Cabbage leaf treatments compared to control For breast pain, cold cabbage leaves may be more effective than routine care (mean difference (MD) -1.03 points on 0-10 visual analogue scale (VAS), 95% confidence intervals (CI) -1.53 to -0.53; 152 women; very low-certainty evidence) or cold gel packs (-0.63 VAS points, 95% CI -1.09 to -0.17; 152 women; very low-certainty evidence), although the evidence is very uncertain. We are uncertain about cold cabbage leaves compared to room temperature cabbage leaves, room temperature cabbage leaves compared to hot water bag, and cabbage leaf extract cream compared to placebo cream because the CIs were wide and included no effect. For breast hardness, cold cabbage leaves may be more effective than routine care (MD -0.58 VAS points, 95% CI -0.82 to -0.34; 152 women; low-certainty evidence). We are uncertain about cold cabbage leaves compared to cold gel packs because the CIs were wide and included no effect. For breast engorgement, room temperature cabbage leaves may be more effective than a hot water bag (MD -1.16 points on 1-6 scale, 95% CI -1.36 to -0.96; 63 women; very low-certainty evidence). We are uncertain about cabbage leaf extract cream compared to placebo cream because the CIs were wide and included no effect. More women were satisfied with cold cabbage leaves than with routine care (risk ratio (RR) 1.42, 95% CI 1.22 to 1.64; 152 women; low certainty), or with cold gel packs (RR 1.23, 95% CI 1.10 to 1.38; 152 women; low-certainty evidence). We are uncertain if women breastfeed longer following treatment with cold cabbage leaves than routine care because CIs were wide and included no effect. Breast swelling and adverse events were not reported. Compress treatments compared to control For breast pain, herbal compress may be more effective than hot compress (MD -1.80 VAS points, 95% CI -2.07 to -1.53; 500 women; low-certainty evidence). Massage therapy plus cactus and aloe compress may be more effective than massage therapy alone (MD -1.27 VAS points, 95% CI -1.75 to -0.79; 100 women; low-certainty evidence). In a comparison of cactus and aloe compress to massage therapy, the CIs were wide and included no effect. For breast hardness, cactus and aloe cold compress may be more effective than massage (RR 0.66, 95% CI 0.51 to 0.87; 102 women; low-certainty evidence). Massage plus cactus and aloe cold compress may reduce the risk of breast hardness compared to massage alone (RR 0.38, 95% CI 0.25 to 0.58; 100 women; low-certainty evidence). We are uncertain about the effects of compress treatments on breast engorgement and cessation of breastfeeding because the certainty of evidence was very low. Among women receiving herbal compress treatment, 2/250 experienced skin irritation compared to 0/250 in the hot compress group (moderate-certainty evidence). Breast swelling and women's opinion of treatment were not reported. Medical treatments compared to placebo Protease may reduce breast pain (RR 0.17, 95% CI 0.04, 0.74; low-certainty evidence; 59 women) and breast swelling (RR 0.34, 95% CI 0.15 to 0.79; 59 women; low-certainty evidence), whereas serrapeptase may reduce the risk of engorgement compared to placebo (RR 0.36, 95% CI 0.14 to 0.88; 59 women; low-certainty evidence). We are uncertain if serrapeptase reduces breast pain or swelling, or if oxytocin reduces breast engorgement compared to placebo, because the CIs were wide and included no effect. No women experienced adverse events in any of the groups receiving serrapeptase, protease or placebo (low-certainty evidence). Breast induration/hardness, women's opinion of treatment and breastfeeding cessation were not reported. Cold gel packs compared to control For breast pain, we are uncertain about the effectiveness of cold gel packs compared to control treatments because the certainty of evidence was very low. For breast hardness, cold gel packs may be more effective than routine care (MD -0.34 points on 1-6 scale, 95% CI -0.60 to -0.08; 151 women; low-certainty evidence). It is uncertain if women breastfeed longer following cold gel pack treatment compared to routine care because the CIs were wide and included no effect. There may be little difference in women's satisfaction with cold gel packs compared to routine care (RR 1.17, 95% CI 0.97 to 1.40; 151 women; low-certainty evidence). Breast swelling, engorgement and adverse events were not reported.
AUTHORS' CONCLUSIONS


Although some interventions may be promising for the treatment of breast engorgement, such as cabbage leaves, cold gel packs, herbal compresses, and massage, the certainty of evidence is low and we cannot draw robust conclusions about their true effects. Future trials should aim to include larger sample sizes, using women - not individual breasts - as units of analysis.",2020,"Among women receiving herbal compress treatment, 2/250 experienced skin irritation compared to 0/250 in the hot compress group (moderate-certainty evidence).","['21 studies (2170 women randomised) conducted in a variety of settings', 'breast engorgement were eligible', 'breastfeeding women']","['cold gel packs', 'routine care (risk ratio (RR', 'placebo', 'interventions: cabbage leaves, various herbal compresses (ginger, cactus and aloe, hollyhock), massage (manual, electromechanical, Oketani), acupuncture, ultrasound, acupressure, scraping therapy, cold packs, and medical treatments (serrapeptase, protease, oxytocin', 'placebo cream', 'Cold gel packs']","['breast pain', 'Breast swelling, engorgement and adverse events', '0-10 visual analogue scale (VAS), 95% confidence intervals (CI', 'skin irritation', 'effectiveness and safety', 'Breast swelling and adverse events', 'adverse events', 'breast swelling', 'risk of breast hardness']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085688', 'cui_str': 'Engorgement of breasts'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006619', 'cui_str': 'Cabbage'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0332260', 'cui_str': 'Compressing'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0330340', 'cui_str': 'Family Cactaceae'}, {'cui': 'C0002168', 'cui_str': 'Aloe'}, {'cui': 'C1025429', 'cui_str': 'Alcea'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0180006', 'cui_str': 'Cold pack'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0074389', 'cui_str': 'serratiopeptidase'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0024902', 'cui_str': 'Pain of breast'}, {'cui': 'C0006152', 'cui_str': 'Swelling of breast'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0269268', 'cui_str': 'Induration of breast'}]",2170.0,0.286029,"Among women receiving herbal compress treatment, 2/250 experienced skin irritation compared to 0/250 in the hot compress group (moderate-certainty evidence).","[{'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zakarija-Grkovic', 'Affiliation': 'Cochrane Croatia, University of Split School of Medicine, Split, Croatia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stewart', 'Affiliation': ""Cochrane Children and Families Network, c/o Cochrane Pregnancy and Childbirth, Department of Women's and Children's Health, The University of Liverpool, Liverpool, UK.""}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006946.pub4']
2977,32944971,Group acceptance and commitment therapy for patients and caregivers in psychosis services: Feasibility of training and a preliminary randomized controlled evaluation.,"OBJECTIVE


Psychological interventions reduce the impact of psychosis, but widescale implementation is problematic. We tested the feasibility of group acceptance and commitment therapy for Psychosis (G-ACTp), delivered by frontline staff, and co-facilitated by service-user experts-by-experience (SU-EbyE), for service-users and informal caregivers (ISRCTN: 68540929). We estimated recruitment/retention rates and outcome variability for future evaluation.
METHODS


Staff and SU-EbyE facilitators completed 1-day workshops, then delivered closely supervised G-ACTp, comprising four sessions (weeks 1-4) and two boosters (10 and 12 weeks). Participants recruited from adult community psychosis services were randomized to receive G-ACTp immediately or after 12 weeks, completing outcome assessments at 0, 4, and 12 weeks. Service-use/month was calculated for 1-year pre-randomization, weeks 0-12, and 5-year uncontrolled follow-up.
RESULTS


Of 41 facilitators trained (29 staff, 12 SU-EbyE), 29 (71%; 17 staff, 12 SU-EbyE) delivered 18 G-ACTp courses. Participant refusal rates were low (9% of service-users [10/112]; 5% of caregivers [4/79]); 60% of those invited to participate attended ≥1 G-ACTp session (64% of service-users [39/61]; 56% of caregivers [35/63]). Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]). Effect sizes ranged from very small to large mostly favouring treatment. Service-use reductions require cautious interpretation, as very few participants incurred costs.
CONCLUSIONS


Implementation appears feasible for service-users; for caregivers, retention needs improving. Outcome variability indicated n = 100-300/arm followed up (α = 0.05, 90% power). Methodological limitations' mean replication is needed: identified sources of potential bias may be reduced in a cluster randomized design with sessional outcome completion.
PRACTITIONER POINTS


Group acceptance and commitment therapy can be successfully adapted for people with psychosis and their caregivers. Implementation (training and delivery) is possible in routine community mental health care settings. Clinical and economic outcomes are promising, but replication is needed. Recommendations are made for future studies.",2020,Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]).,"['people with psychosis and their caregivers', 'patients and caregivers in psychosis services', 'Participants recruited from adult community psychosis services']",['G-ACTp'],['Participant refusal rates'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}]",,0.209622,Randomization of facilitators and participants proved problematic and participant follow-up was incomplete (78% [66/85]; 82% of service-users [36/44]; 73% of caregivers [30/41]).,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jolley', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Louise C', 'Initials': 'LC', 'LastName': 'Johns', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': ""O'Donoghue"", 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'University College London, UK.'}, {'ForeName': 'Mizanur', 'Initials': 'M', 'LastName': 'Khondoker', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Butler', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'De Rosa', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Leal', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McGovern', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Brigita', 'Initials': 'B', 'LastName': 'Rasiukeviciute', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Sim', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}]",The British journal of clinical psychology,['10.1111/bjc.12265']
2978,32945015,Near visual function measured with a novel tablet application in patients with astigmatism.,"CLINICAL RELEVANCE


While the clinical focus of performance metrics is traditionally based on visual acuity, research from the field of visual impairment has demonstrated that metrics such as reading speed and critical print size correlate much more strongly with subjective patient reported outcomes and assessed ability in real-world tasks.
BACKGROUND


More recently, digital device use has increasingly replaced many paper-based tasks. Therefore, this study aimed to assess the correlation between standard acuity/contrast metrics and functional reading ability compared to real-world performance on an iPad-based reading task with astigmatic patients corrected wearing toric and mean spherical equivalent contact lenses.
METHODS


Thirty-four adult participants, with -0.75 to -1.50 D of refractive astigmatism, were enrolled in a double-masked cross-over study and fitted with toric and spherical equivalent contact lenses, in random order. A digital application was developed to assess zoom, contrast modifications, the distance at which the tablet was held, blink rate, and time to complete the reading task. High and low contrast near logMAR visual acuity were measured along with reading performance (critical print size and optimal reading speed).
RESULTS


The amount participants chose to increase tablet font size (zoom) was correlated with their high-contrast visual acuity with toric correction (r = 0.434, p = 0.010). With best sphere correction, zoom was associated with reading speed (r = -0.450, p = 0.008) and working distance (r = 0.522, p = 0.002). Text zoom was also associated with horizontal (toric: r = 0.898, p < 0.001; sphere: r = 0.880, p < 0.001) and vertical scrolling (toric: r = 0.857, p < 0.001; sphere: r = 0.846, p < 0.001). There was a significant negative association between the selection of text contrast and zoom (toric: r = -0.417, p = 0.0141; sphere: r = -0.385, p = 0.025).
CONCLUSION


Real-world task performance allows more robust assessment of visual function than standard visual metrics alone. Digital technology offers the opportunity to better understand the impact of different vision correction options on real-world task performance.",2020,"With best sphere correction, zoom was associated with reading speed (r = -0.450, p = 0.008) and working distance (r = 0.522, p = 0.002).","['sphere', 'Thirty-four adult participants, with -0.75 to -1.50', 'D of refractive astigmatism, were enrolled in a double-masked cross-over study and fitted with toric and spherical equivalent contact lenses, in random order', 'patients with astigmatism']",[],"['working distance', 'reading speed', 'High and low contrast near logMAR visual acuity', 'visual function']","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",34.0,0.142276,"With best sphere correction, zoom was associated with reading speed (r = -0.450, p = 0.008) and working distance (r = 0.522, p = 0.002).","[{'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'The Ocular Surface Institute, University of Houston College of Optometry, Houston, Texas, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Richdale', 'Affiliation': 'The Ocular Surface Institute, University of Houston College of Optometry, Houston, Texas, USA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Tomiyama', 'Affiliation': 'The Ocular Surface Institute, University of Houston College of Optometry, Houston, Texas, USA.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'The Ocular Surface Institute, University of Houston College of Optometry, Houston, Texas, USA.'}, {'ForeName': 'Anna-Kaye M', 'Initials': 'AM', 'LastName': 'Logan', 'Affiliation': 'The Ocular Surface Institute, University of Houston College of Optometry, Houston, Texas, USA.'}, {'ForeName': 'Kelsea', 'Initials': 'K', 'LastName': 'Skidmore', 'Affiliation': 'The Ocular Surface Institute, University of Houston College of Optometry, Houston, Texas, USA.'}, {'ForeName': 'Moriah A', 'Initials': 'MA', 'LastName': 'Chandler', 'Affiliation': ''}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Ritchey', 'Affiliation': 'The Ocular Surface Institute, University of Houston College of Optometry, Houston, Texas, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Optometry and Vision Science Research Group, Aston University, Birmingham, UK.'}]",Clinical & experimental optometry,['10.1111/cxo.13138']
2979,32945020,"Falls risk score removal does not impact inpatient falls: A stepped-wedge, cluster-randomised trial.","AIMS


To investigate the impact of removing a falls risk screening tool from an overall falls risk assessment program on the rate of falls, injurious falls, and completion of falls prevention activities by staff.
BACKGROUND


Falls in older patients are common adverse events in hospital settings. Screening and assessing individual patients for risk of falls is a common, but controversial element of falls prevention strategies in hospitals.
DESIGN


A stepped-wedge, cluster randomised controlled trial using a disinvestment approach METHODS: This trial was carried out according to the Consolidated Standards of Reporting Trials (CONSORT). All patients were admitted to 20 health service wards (9 units) over the 10-month study period. The control condition contained a falls risk screening tool element, a full falls risk factor assessment and intervention provision section. In the intervention condition, only the full falls risk factor assessment and intervention provision section was applied, and the falls risk screening tool element was removed. Fall rates were extracted from hospital level data, files were audited for tool completion and nurses surveyed about tool use.
RESULTS


There did not appear to be an impact on the falls rate per month when the risk screening tool component was removed (Incidence rate ratio (IRR)=0.84 - favours intervention, 95%CI=0.67 to 1.05, p=0.14) nor on the falls rate with serious injury (IRR=0.90, 95%CI=0.26 to 3.09, p=0.87). There was a thirty-six second reduction of time per patient reported by staff to complete paperwork (p<0.001). There was no difference in the proportion of patients for whom the tool was completed, nor the number of falls prevention interventions identified for implementation.
CONCLUSION


Removing the falls risk screening tool section did not negatively impact falls and reduced time spent completing falls prevention paperwork.
RELEVANCE TO CLINICAL PRACTICE


Falls prevention is an important issue in health services. Removal of a screening risk tool is unlikely to impact falls. This has the potential to reduce nursing administration time that may be otherwise redirected to individual approaches to falls prevention.",2020,"There was no difference in the proportion of patients for whom the tool was completed, nor the number of falls prevention interventions identified for implementation.
CONCLUSION


Removing the falls risk screening tool section did not negatively impact falls and reduced time spent completing falls prevention paperwork.
","['older patients', 'All patients were admitted to 20 health service wards (9 units) over the 10-month study period']",[],"['Fall rates', 'falls rate with serious injury', 'rate of falls, injurious falls, and completion of falls prevention activities']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0534531,"There was no difference in the proportion of patients for whom the tool was completed, nor the number of falls prevention interventions identified for implementation.
CONCLUSION


Removing the falls risk screening tool section did not negatively impact falls and reduced time spent completing falls prevention paperwork.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jellett', 'Affiliation': 'Peninsula Health, Falls Prevention Service, Separation St Mornington, Vic, 3931, Australia.'}, {'ForeName': 'Cylie', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Peninsula Health, Allied Health, 4 Hastings Rd, Frankston, VIC, 3199, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Clayton', 'Affiliation': 'Peninsula Health, Falls Prevention Service, Separation St Mornington, Vic, 3931, Australia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Plummer', 'Affiliation': ""Monash University School of Nursing and Midwifery, McMahon's Rd, Frankston, VIC, 3199, Australia.""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': ""Monash University, School of Primary and Allied Health Care & National Centre for Healthy Ageing, McMahon's Rd, Frankston, VIC, 3199, Australia.""}]",Journal of clinical nursing,['10.1111/jocn.15471']
2980,32945218,Impact of myoinositol with metformin and myoinositol alone in infertile PCOS women undergoing ovulation induction cycles - randomized controlled trial.,"PURPOSE


To evaluate the benefits of myoinositol plus metformin versus myoinositol alone in infertile polycystic ovarian syndrome (PCOS) women undergoing ovulation induction cycles.
MATERIALS AND METHODS


Total 116 infertile PCOS women were randomized: Group I (n = 57): metformin (1500 mg) plus myoinositol (4 g) per day; Group II (n=59): myoinositol 4 g per day. Subjects were advised to try for spontaneous conception. Those who did not conceive after three months were given three cycles of ovulation induction. Primary outcome was clinical pregnancy rate after 6 months. Secondary outcomes were improvement in metabolic and endocrine parameters, ongoing pregnancy, abortion and multiple pregnancy rate.
RESULTS


Baseline demographic, metabolic and hormonal parameters were comparable in two groups. After 3 months of therapy, both study groups had comparable improvement in metabolic and hormonal parameters. After 6 months, clinical pregnancy rate was 42.0% in Group I and 45.5% Group II respectively (RR 0.92(95% CI:0.60-1.43) (p > .05). Side-effects (mainly gastrointestinal) were significantly higher in Group I than group II.
CONCLUSIONS


Myoinositol (4 g) might be used alone as an insulin sensitizer to improve metabolic, hormonal and reproductive outcome in infertile PCOS women. Further studies with large numbers are warranted to confirm the role of myoinostiol as a sole insulin sensitizer.",2020,"After 6 months, clinical pregnancy rate was 42.0% in Group I and 45.5% Group II respectively (RR 0.92(95% CI:0.60-1.43) (p > .05).","['Total 116 infertile PCOS women', 'infertile PCOS women undergoing ovulation induction cycles', 'infertile polycystic ovarian syndrome (PCOS) women undergoing ovulation induction cycles', 'infertile PCOS women']","['myoinositol plus metformin', 'myoinositol alone', 'metformin (1500\u2009mg) plus myoinositol', 'myoinositol 4\u2009g per day', 'myoinositol with metformin and myoinositol alone']","['metabolic and endocrine parameters, ongoing pregnancy, abortion and multiple pregnancy rate', 'metabolic and hormonal parameters', 'Side-effects (mainly gastrointestinal', 'clinical pregnancy rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}]","[{'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",116.0,0.18781,"After 6 months, clinical pregnancy rate was 42.0% in Group I and 45.5% Group II respectively (RR 0.92(95% CI:0.60-1.43) (p > .05).","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Prabhakar', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Mahey', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khadgawat', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Kachhawa', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jai Bhagwan', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Perumal', 'Initials': 'P', 'LastName': 'Vanamail', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1810657']
2981,32945221,Preliminary Improvements in Dynamic Postural Control after A Group-based Intervention Program for Children with Developmental Coordination Disorder: A Brief Report.,"OBJECTIVE


To determine the value of a traditional (easy to implement) group-based intervention program on both static and dynamic postural control in children with Developmental Coordination Disorder (DCD).
METHODS


Sway and stability indices were measured with the Clinical Test of Sensory Integration in Balance (CTSIB) and efficiency of goal-directed movement was measured during a Limits-of-Stability (LoS) task, before and after the intervention program. The intervention involved a total of 10 one-hour group sessions, administered once per week for 10 weeks.
RESULTS


Results indicated significant group increases in dynamic postural control ( p < .05). These results suggest it is possible to improve dynamic postural control in this population. This type of intervention does not require any expensive materials, it is feasible, and easy-to-implement to a group of children.
CONCLUSION


We conclude that this simple form of intervention involving fun group activities can significantly improve dynamic postural control in children with DCD.",2020,We conclude that this simple form of intervention involving fun group activities can significantly improve dynamic postural control in children with DCD.,"['Children with Developmental Coordination Disorder', 'children with DCD', 'children with Developmental Coordination Disorder (DCD']",['traditional (easy to implement) group-based intervention program'],"['Clinical Test of Sensory Integration in Balance (CTSIB) and efficiency of goal-directed movement was measured during a Limits-of-Stability (LoS) task', 'dynamic postural control', 'Dynamic Postural Control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",,0.0163471,We conclude that this simple form of intervention involving fun group activities can significantly improve dynamic postural control in children with DCD.,"[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Tamplain', 'Affiliation': 'University of Texas at Arlington , Arlington, TX, USA.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Sherrod', 'Affiliation': 'University of North Texas Health Science Center , Fort Worth, TX, USA.'}, {'ForeName': 'Chadwick', 'Initials': 'C', 'LastName': 'Fuchs', 'Affiliation': 'University of Texas at Arlington , Arlington, TX, USA.'}, {'ForeName': 'Haylie L', 'Initials': 'HL', 'LastName': 'Miller', 'Affiliation': 'University of North Texas Health Science Center , Fort Worth, TX, USA.'}]",Developmental neurorehabilitation,['10.1080/17518423.2020.1819463']
2982,32940765,"Vaginal tablets of dequalinium chloride 10 mg versus clotrimazole 100 mg for vaginal candidiasis: a double-blind, randomized study.","PURPOSE


To compare the clinical response, microscopic examination and fungal culture between dequalinium chloride (DQC) and clotrimazole (CT) for treating vaginal candidiasis (VC).
METHODS


The double-blind, randomized study was conducted from September 2014 to September 2016 at Siriraj Hospital, Thailand. Eligible participants were Thai women diagnosed with VC by microscopic examination. The exclusion criteria included immunocompromised conditions, consumption of antifungal drugs, and having recurrent VC. Each participant was randomized with a 1:1 allocation to receive six vaginal tablets of 100 mg CT or 10 mg DQC. Two visits included 10 ± 2 days (C1) and 38 ± 4 days (C2). Outcome measures were improvement of VC symptoms, microscopic examination, culture, satisfaction and tolerability.
RESULTS


Of 155 eligible participants, 150 were randomized and allocated into CT (N = 76) and DQC (N = 74). The average age was 31.1 ± 7.2 years. Comparable improvement of clinical response was demonstrated (OR at C1 0.79, 95% CI 0.56-1.10, p = 0.197; and OR at C2 0.99, 95% CI 0.69-1.43, p = 0.985). Of CT and DQC groups, the microscopic examination was positive at 11/75 (14.9%) vs 18/72 (25.3%) at C1 and 18/74 (24.3%) vs 28/66 (42.4%) at C2. And the culture was positive at 25/75 (33.8%) vs 46/72 (65.7%) at C1 and at 26/74 (36.6%) vs 46/66 (69.7%) at C2. Most participants had high satisfaction and tolerability and none reported any side effects.
CONCLUSION


DQC and CT show comparable clinical response but CT results in greater improvement of microscopic examination and fungal culture.
CLINICAL TRIAL REGISTRATION


The Clinical Trial Registry number was NCT02242695. (September 17, 2014).",2020,"Comparable improvement of clinical response was demonstrated (OR at C1 0.79, 95% CI 0.56-1.10, p = 0.197; and OR at C2 0.99, 95% CI 0.69-1.43, p = 0.985).","['Eligible participants were Thai women diagnosed with VC by microscopic examination', 'September 2014 to September 2016 at Siriraj Hospital, Thailand', 'vaginal candidiasis', '155 eligible participants']","['dequalinium chloride (DQC) and clotrimazole (CT', 'DQC and CT', 'CT', 'six vaginal tablets of 100\xa0mg CT or 10\xa0mg DQC', 'dequalinium chloride 10\xa0mg versus clotrimazole', 'DQC']","['clinical response', 'microscopic examination and fungal culture', 'microscopic examination', 'VC symptoms, microscopic examination, culture, satisfaction and tolerability']","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006852', 'cui_str': 'Candidiasis of vagina'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]","[{'cui': 'C0011087', 'cui_str': 'Dequalinium chloride'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0200954', 'cui_str': 'Mycology culture'}, {'cui': 'C0006852', 'cui_str': 'Candidiasis of vagina'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",155.0,0.411596,"Comparable improvement of clinical response was demonstrated (OR at C1 0.79, 95% CI 0.56-1.10, p = 0.197; and OR at C2 0.99, 95% CI 0.69-1.43, p = 0.985).","[{'ForeName': 'Manopchai', 'Initials': 'M', 'LastName': 'Thamkhantho', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand.'}, {'ForeName': 'Chenchit', 'Initials': 'C', 'LastName': 'Chayachinda', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand. chenchit.cha@mahidol.ac.th.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05784-z']
2983,32940769,"Retraction Note to: Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.","The Editor-in-Chief has retracted this article [1]. Following publication, concerns were raised with respect to data and data analyses present in the article.",2020,"Following publication, concerns were raised with respect to data and data analyses present in the article.",['patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation'],['Bismuth adjuvant'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]",[],,0.145238,"Following publication, concerns were raised with respect to data and data analyses present in the article.","[{'ForeName': 'Per Boye', 'Initials': 'PB', 'LastName': 'Hansen', 'Affiliation': 'Department of Hematology, Herlev Hospital, University of Copenhagen, 2720, Herlev, Denmark. pbhn@regionsjaelland.dk.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Penkowa', 'Affiliation': 'Section for Neuroprotection, Hjerneeksperten, 1718, Copenhagen, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05770-w']
2984,32940786,Effects of rhythmic auditory stimulation on upper-limb movement speed in patients with schizophrenia spectrum disorders.,"Movement slowness, linked to dysfunctional basal ganglia and cerebellum, is prevalent but lacks effective therapy in patients with schizophrenia spectrum disorders. This study was to examine immediate effects of rhythmic auditory stimulation (RAS) on upper-limb movement speed in patients. Thirty patients and 30 psychiatrically healthy people executed the right-hand task and the both-hand task of the Purdue Pegboard Test when listening to RAS with two tempi: normal (equal to the fastest movement tempo for each participant without RAS) and fast (120% of the normal tempo). The testing order of the RAS tempi for each participant was randomized. Patients had lower scores of right-hand and both-hand tasks than did psychiatrically healthy people. Scores of right-hand and both-hand tasks were higher in the fast-RAS condition than the normal-RAS condition in participants. This is the first study to explore the possibility of applying RAS to movement therapy for patients with schizophrenia spectrum disorders. The results demonstrated that faster RAS was effective in inducing faster upper-limb movements in patients and psychiatrically healthy people, suggesting that manipulating RAS may be a feasible therapeutic strategy utilized to regulate movement speed. The RAS may involve alternative neural pathways to modulate movement speed and thus to compensate for impaired function of basal ganglia and cerebellum in patients.",2020,Scores of right-hand and both-hand tasks were higher in the fast-RAS condition than the normal-RAS condition in participants.,"['patients with schizophrenia spectrum disorders', 'patients', 'Thirty patients and 30 psychiatrically healthy people executed the right-hand task and the both-hand task of the', 'patients and psychiatrically healthy people']","['Purdue Pegboard Test when listening to RAS with two tempi: normal (equal to the fastest movement tempo for each participant without RAS', 'rhythmic auditory stimulation (RAS', 'rhythmic auditory stimulation']",['Scores of right-hand and both-hand tasks'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}]","[{'cui': 'C0204462', 'cui_str': 'Purdue pegboard test'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0230377', 'cui_str': 'Both hands'}]",,0.044629,Scores of right-hand and both-hand tasks were higher in the fast-RAS condition than the normal-RAS condition in participants.,"[{'ForeName': 'Shu-Mei', 'Initials': 'SM', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong. shumei.wang@polyu.edu.hk.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Institute of Allied Health Sciences, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Tracy Ho-Yan', 'Initials': 'TH', 'LastName': 'Tse', 'Affiliation': 'New Life Psychiatric Rehabilitation Association, New Territories, Tuen Mun, Hong Kong.'}, {'ForeName': 'Hin-Lun', 'Initials': 'HL', 'LastName': 'Chu', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Cheong-Ho', 'Initials': 'CH', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Tsz-Ho', 'Initials': 'TH', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Chun-Kwok', 'Initials': 'CK', 'LastName': 'Tse', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Wai-Man', 'Initials': 'WM', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Sunny Ho-Wan', 'Initials': 'SH', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Kowloon, Hong Kong.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-020-01193-0']
2985,32940793,Two-dimensional (2-D) vs. three-dimensional (3-D) laparoscopic right hemicolectomy with intracorporeal anastomosis for colon cancer: comparison of short-term results.,"BACKGROUND


There are few reports comparing safety and efficacy of 2-D and 3-D video technology in laparoscopic right hemicolectomy. The aim of the study was to assess the short-term results of laparoscopic right hemicolectomy (LHR) with intracorporeal anastomosis with 2-D/3-D video in patients with right colon cancer.
METHODS


Data from 239 patients undergoing LRH for cancer in a 14-year period (June 2005-January 2020) were prospectively collected. Surgical procedures were performed by two expert laparoscopic surgeons.
RESULTS


One hundred and fourteen patients were included in the study: 55 (48.2%) operated with 2-D and 59 (51.8%) with 3-D video. Tumor site and postoperative stage distribution were similar. Mean operative time was comparable in the two groups (159.0 ± 48.8 min vs. 17.06 ± 36.0 min, p = ns, group 2-D and 3-D, respectively). Group 3-D patients had a similar percentage of associated procedures (44.1% vs. 29.1%, p = ns). Intraoperative complications were nil in both groups, while postoperative complications were similar (30.9% 2-D vs 25.4% 3-D, p = ns). The mean number of lymph nodes retrieved was similar in group 3-D (26.0 ± 14.6 vs. 22.9 ± 9.3, p = ns) and the length of stay was comparable in 3-D and 2-D patients (8.4 ± 2.6 vs. 9.1 ± 3.3 days, respectively, p = ns).
CONCLUSIONS


Laparoscopic 3-D vision is as equally effective as 2-D vision in LRH with intracorporeal anastomosis, with a similar proportion of associated procedures and number of lymph nodes retrieved in the same operative time. Further prospective larger randomized studies are necessary to verify if LRH with 3-D video can reduce postoperative complications, compared to 2-D video.",2020,"Mean operative time was comparable in the two groups (159.0 ± 48.8 min vs. 17.06 ± 36.0 min, p = ns, group 2-D and 3-D, respectively).","['239 patients undergoing LRH for cancer in a 14-year period (June 2005-January 2020', 'One hundred and fourteen patients were included in the study: 55 (48.2%) operated with 2-D and 59 (51.8%) with 3-D video', 'patients with right colon cancer']","['laparoscopic right hemicolectomy (LHR', 'intracorporeal anastomosis with 2-D/3-D video', 'Two-dimensional (2-D) vs. three-dimensional (3-D) laparoscopic right hemicolectomy with intracorporeal anastomosis']","['mean number of lymph nodes', 'Intraoperative complications', 'postoperative complications', 'Tumor site and postoperative stage distribution', 'length of stay', 'Mean operative time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C5191314', 'cui_str': '48.2'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}]","[{'cui': 'C0585464', 'cui_str': 'Laparoscopic-assisted right colectomy'}, {'cui': 'C0201504', 'cui_str': 'Histamine release from leukocytes measurement'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0475445', 'cui_str': 'Tumor site'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",239.0,0.152974,"Mean operative time was comparable in the two groups (159.0 ± 48.8 min vs. 17.06 ± 36.0 min, p = ns, group 2-D and 3-D, respectively).","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Portale', 'Affiliation': 'Department of General Surgery, Azienda Euganea ULSS 6, Via Casa di Ricovero, 40, 35013, Cittadella, Italy. portale@surgery.usc.edu.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Pedon', 'Affiliation': 'Department of General Surgery, Azienda Euganea ULSS 6, Via Casa di Ricovero, 40, 35013, Cittadella, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Benacchio', 'Affiliation': 'Department of Epidemiology, Azienda Euganea ULSS 6, Padua, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cipollari', 'Affiliation': 'Department of General Surgery, Azienda Euganea ULSS 6, Via Casa di Ricovero, 40, 35013, Cittadella, Italy.'}, {'ForeName': 'Valentino', 'Initials': 'V', 'LastName': 'Fiscon', 'Affiliation': 'Department of General Surgery, Azienda Euganea ULSS 6, Via Casa di Ricovero, 40, 35013, Cittadella, Italy.'}]",Surgical endoscopy,['10.1007/s00464-020-07977-8']
2986,32940866,"Long Alimentary Limb Duodenal Switch (LADS): an Exploratory Randomized Trial, Results at 2 Years.","PURPOSE


The effectiveness of the standard biliopancreatic diversion with duodenal switch (BPD/DS) in terms of weight loss has been demonstrated. Increasing the strict alimentary limb length while maintaining the length of the common channel could lead to similar weight loss while reducing side effects.
MATERIALS AND METHODS


The objective was to evaluate the effect of increasing the strict alimentary limb length on weight loss, comorbidities, nutritional deficiencies, and quality of life 2 years after surgery, compared with standard BPD/DS. An exploratory randomized, double-blind study evaluated the results of LADS at 2 years in comparison with the standard BPD/DS. Common channel was kept at 100 cm in both groups while alimentary limb was created at 100 cm from Treitz angle in the LADS group and at 150 cm total in the BPD/DS group.
RESULTS


Twenty patients were recruited from May 2013 to June 2015. Mean percentage of excess weight loss was statistically significantly lower in the LADS group at 24 months (81.6 ± 6.6% in the LADS group and 97.1 ± 11.1% in the BPD/DS group (p = 0.001). No significant difference regarding the rate of remission of comorbidities was noted. Mean calcium, vitamin D, hemoglobin, zinc, and copper levels were statistically lower in the BPD/DS group. Quality of life was significantly improved in both groups, with no statistically significant difference between the two groups.
CONCLUSIONS


At 24 months, weight loss was lower in the LADS group. However, no difference was observed in the improvement in quality of life. LADS technique was discontinued following this study.
TRIAL REGISTRATION


ClinicalTrial.gov Ref. NCT03097926.",2020,"Quality of life was significantly improved in both groups, with no statistically significant difference between the two groups.
","['Long Alimentary Limb Duodenal Switch (LADS', 'Twenty patients were recruited from May 2013 to June 2015']","['standard BPD/DS', 'LADS', 'standard biliopancreatic diversion with duodenal switch (BPD/DS']","['weight loss', 'Mean percentage of excess weight loss', 'Mean calcium, vitamin D, hemoglobin, zinc, and copper levels', 'rate of remission of comorbidities', 'weight loss, comorbidities, nutritional deficiencies, and quality of life 2\xa0years', 'Quality of life', 'quality of life']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1960687', 'cui_str': 'Duodenal switch'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}, {'cui': 'C1960687', 'cui_str': 'Duodenal switch'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",20.0,0.0536809,"Quality of life was significantly improved in both groups, with no statistically significant difference between the two groups.
","[{'ForeName': 'François-Charles', 'Initials': 'FC', 'LastName': 'Malo', 'Affiliation': 'Department of surgery, Centre hospitalier universitaire de Sherbrooke - Université de Sherbrooke, Sherbrooke, Québec, Canada. francois-charles.malo@usherbrooke.ca.'}, {'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Marion', 'Affiliation': 'Department of surgery, Centre hospitalier universitaire de Sherbrooke - Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Rioux', 'Affiliation': 'Department of surgery, Centre hospitalier universitaire de Sherbrooke - Université de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Stéfane', 'Initials': 'S', 'LastName': 'Lebel', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Hould', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Julien', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Marceau', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Lescelleur', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lafortune', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Léonie', 'Initials': 'L', 'LastName': 'Bouvet-Bouchard', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Biertho', 'Affiliation': 'Department of surgery, Institut universitaire de cardiologie et pneumologie de Québec - Université Laval, Québec, Canada.'}]",Obesity surgery,['10.1007/s11695-020-04968-5']
2987,32940890,Healthy behaviors are associated with positive outcomes for cancer survivors with ostomies: a cross-sectional study.,"BACKGROUND


Cancer survivors (CS) with ostomies may face challenges in sustaining physical activity (PA) levels and maintaining healthy diets. This analysis describes lifestyle behaviors and their relationships with health-related quality of life (HRQOL) in CS with ostomies.
METHODS


This is a cross-sectional, secondary analysis of a multisite randomized self-management education trial for CS with ostomies. The baseline self-reported measures were queried on aerobic PA and diet using the City of Hope Quality of Life Ostomy measure, and the Self-Efficacy to Perform Self-Management Behaviors questionnaire (SE). PA was compared against the American Cancer Society PA guidelines for CS. Relationships between PA and HRQOL were evaluated using multiple linear regression, stratified by BMI.
RESULTS


Among 200 responders, fewer than 20% met or exceeded the PA guideline for cancer survivors; overall, confidence in the ability to perform gentle or aerobic PA was moderate (6/10 on the SE). Overall HRQOL (p = 0.038), psychological well-being (p = 0.017), and physical strength (p = 0.025) were associated with increased PA. Almost half (48.7%) of CS reported a special diet. CS with urostomies were less likely to report diet adjustments after their ostomy surgeries (OR: 0.16, 95% CI [0.08-0.38]) than CS with fecal ostomies.
CONCLUSIONS


Better HRQOL is associated with PA guideline achievement among CS with ostomies. Additionally, diet adjustments were reported more frequently in CS with fecal ostomies. Our findings bear clinical relevance for designing ostomy self-management and lifestyle recommendations for CS with ostomies.
IMPLICATIONS FOR CANCER SURVIVORS


The evaluation of lifestyle behaviors may be an especially important focus for CS with ostomies.",2020,"Overall HRQOL (p = 0.038), psychological well-being (p = 0.017), and physical strength (p = 0.025) were associated with increased PA.","['Cancer survivors (CS', '200 responders', 'FOR CANCER SURVIVORS', 'cancer survivors with ostomies']",[],"['physical strength', 'aerobic PA and diet using the City of Hope Quality of Life Ostomy measure, and the Self-Efficacy to Perform Self-Management Behaviors questionnaire (SE', 'Overall HRQOL']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0029473', 'cui_str': 'Construction of stoma'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029473', 'cui_str': 'Construction of stoma'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.0428199,"Overall HRQOL (p = 0.038), psychological well-being (p = 0.017), and physical strength (p = 0.025) were associated with increased PA.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Department of Surgery, University of Pennsylvania, 3400 Spruce St., 4 Silverstein, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Mel & Enid Zuckerman College of Public Health and University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Sun', 'Affiliation': 'Division of Nursing Research and Education, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Wendel', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Hornbrook', 'Affiliation': 'Center for Health Research, Kaiser Permanente, Portland, OR, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Weinstein', 'Affiliation': 'Arizona Telemedicine Program, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ercolano', 'Affiliation': 'School of Nursing, Yale University, West Haven, CT, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Grant', 'Affiliation': 'Division of Nursing Research and Education, City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Zuleyha', 'Initials': 'Z', 'LastName': 'Cidav', 'Affiliation': 'Center for Mental Health, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'McCorkle', 'Affiliation': 'School of Nursing, Yale University, West Haven, CT, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Krouse', 'Affiliation': 'Department of Surgery, University of Pennsylvania, 3400 Spruce St., 4 Silverstein, Philadelphia, PA, 19104, USA. robert.krouse@pennmedicine.upenn.edu.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-020-00940-5']
2988,32940893,"Efficacy of Sodium Tanshinone IIA Sulfonate in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Controlled, Randomized Trial.","BACKGROUND


Sodium tanshinone IIA sulfonate (STS) has been widely used by Chinese medicine practitioners for chronic cardiovascular diseases. However, its direct clinical efficacy in patients with acute coronary syndrome following percutaneous coronary intervention (PCI) has not been reported yet. The present trial aimed to investigate potential cardioprotection of STS in patients undergoing PCI for non-ST elevation acute coronary syndrome (NSTE-ACS).
METHODS


In a randomized, double-blind, placebo-controlled trial, 372 patients with NSTE-ACS were randomly assigned to receive STS (n = 192) or saline (n = 180) for 2 days before and 3 days after PCI along with standard therapy. The primary endpoint was the composite incidence of major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, repeated revascularization of the target vessel, and stent thrombosis, within 30 days after PCI.
RESULTS


The 30-day MACEs occurred in 18.8% of the patients in the STS group and in 27.2% of the patients in the control group (P = 0.038); this difference was mostly driven by reduction of myocardial infarction incidence (17.2% vs. 26.7%, P = 0.027). Post-procedural elevation of troponin-I was also significantly lower in the STS group (26.56% vs. 47.78%, P < 0.001). Multivariable analysis identified STS as a predictor of decreased risk of MACE occurrence (odds ratio: 0.60, 95% confidence interval: 0.36 to 0.99; P = 0.045).
CONCLUSION


Addition of STS to the standard treatments recommended by the current practice guidelines in patients with NSTE-ACS undergoing PCI could reduce myocardial injury and the occurrence of short-term cardiovascular events, primarily driven by non-fatal myocardial infarction.
TRIAL REGISTRATION


ChiCTR-TRC-14005182.",2020,"I was also significantly lower in the STS group (26.56% vs. 47.78%, P < 0.001).","['patients with acute coronary syndrome', '372 patients with NSTE-ACS', 'Chinese medicine practitioners for chronic cardiovascular diseases', 'patients with NSTE-ACS undergoing', 'Patients with Non-ST Elevation Acute Coronary Syndrome', 'patients undergoing PCI for non-ST elevation acute coronary syndrome (NSTE-ACS']","['PCI', 'percutaneous coronary intervention (PCI', 'STS', 'saline', 'placebo', 'troponin', 'Sodium Tanshinone IIA Sulfonate', 'Percutaneous Coronary Intervention', 'Sodium tanshinone IIA sulfonate (STS']","['myocardial infarction incidence', 'risk of MACE occurrence', 'composite incidence of major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, repeated revascularization of the target vessel, and stent thrombosis', '30-day MACEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0075811', 'cui_str': 'tanshinone II A sodium sulfonate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",372.0,0.573907,"I was also significantly lower in the STS group (26.56% vs. 47.78%, P < 0.001).","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Mao', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Liheng', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Dongfang Hospital of Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China.'}, {'ForeName': 'Hongcai', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of ME and Beijing, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China. minzhouzhang@aliyun.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Hinek', 'Affiliation': 'Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, Canada.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07077-8']
2989,32940955,Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5.,"BACKGROUND


N8-GP (turoctocog alfa pegol; Esperoct ®  , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated, extended half-life human recombinant factor VIII (FVIII).
OBJECTIVE


Here, we report end-of-trial safety and efficacy results from the completed N8-GP pathfinder5 trial.
METHODS


pathfinder5 (NCT01731600) was a multi-national, open-label, single-arm, non-randomized, non-controlled trial in previously treated male patients aged <12 years old with severe hemophilia A that comprised a main and an extension phase. During the main phase, patients received twice-weekly N8-GP 60 IU/kg for 50 exposure days (~26 weeks). During the extension phase, patients received the same regimen until the end of trial (first patient in main phase, 20 February 2013; trial end, 28 September 2018).
RESULTS


Sixty-eight patients were exposed to N8-GP for a median time of ~4.9 years on regimen. Of the 63 patients who started in the extension phase, 62 completed the trial. No FVIII inhibitors (≥0.6 BU) or other safety concerns were detected. The overall estimated annualized bleeding rate was 1.08 (median 0.81), and nearly 20% of patients had no bleeds during the entire trial. The proportion of patients with no annual bleeds increased with time, with 56% of patients experiencing no bleeds and 86% experiencing no spontaneous bleeds during the fourth year of exposure. All baseline target joints of patients who participated in both phases of this trial were resolved in slightly over 2 years.
CONCLUSION


Overall, data from the completed pathfinder5 trial show that long-term (median 4.9 years) N8-GP treatment was efficacious and well tolerated in previously treated pediatric patients with severe hemophilia A.",2020,"The proportion of patients with no annual bleeds increased with time, with 56% of patients experiencing no bleeds and 86% experiencing no spontaneous bleeds during the fourth year of exposure.","['pediatric patients with severe hemophilia A', '63 patients who started in the extension phase, 62 completed the trial', 'male patients aged <12\xa0years old with severe hemophilia', 'Sixty-eight patients', 'previously treated pediatric patients with hemophilia A']",['N8-GP'],"['efficacious and well tolerated', 'annualized bleeding rate', 'spontaneous bleeds', 'proportion of patients with no annual bleeds']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",[],"[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",68.0,0.197585,"The proportion of patients with no annual bleeds increased with time, with 56% of patients experiencing no bleeds and 86% experiencing no spontaneous bleeds during the fourth year of exposure.","[{'ForeName': 'Sonata', 'Initials': 'S', 'LastName': 'Šaulytė Trakymienė', 'Affiliation': ""Center for Pediatric Oncology and Hematology, Children's Hospital, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Economou', 'Affiliation': '1st Department of Pediatrics, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Kenet', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Landorph', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Chunduo', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kearney', 'Affiliation': ""Center for Bleeding and Clotting Disorders, Children's Hospital Minnesota, Minneapolis, MN, USA.""}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15036']
2990,32939865,Perioperative improvement in serum albumin level in patients with left ventricular assist device.,"BACKGROUND


The negative impact of baseline hypoalbuminemia on clinical outcome following left ventricular assist device (LVAD) implantation is well known. However, the implications of perioperative change in serum albumin levels on post-LVAD outcomes remain uninvestigated.
METHODS


Among consecutive patients with baseline serum albumin <3.5 g/dl who received durable LVAD implantation between April 2014 and August 2017 and were followed for 1 year, the impact of perioperative change in serum albumin level from baseline to 3 months post-LVAD on the incidence of adverse events was investigated.
RESULTS


Sixty-eight patients (median 60 years and 69% male) were included. Serum albumin change was an independent predictor of the occurrence of adverse events with an adjusted hazard ratio of 0.32 (95% confidence interval, 0.13-0.78) and a cutoff change of 0.7 g/dl. Those with albumin increase >0.7 g/dl had higher 1-year freedom from adverse events (45% vs. 14%, p = .008), dominantly due to lower incidence of death or sepsis compared with those without (p < .05 for both).
CONCLUSION


Among those with baseline hypoalbuminemia, a considerable perioperative increase in serum albumin levels following LVAD implantation was associated with lower mortality and morbidity. The implication of aggressive nutrition intervention on LVAD patients is the next concern.",2020,"Those with albumin increase >0.7 g/dl had higher 1-year freedom from adverse events (45% vs. 14%, p = .008), dominantly due to lower incidence of death or sepsis compared with those without (p < .05 for both).
","['Among consecutive patients with baseline serum albumin <3.5\u2009g/dl who received durable LVAD implantation between April 2014 and August 2017', 'LVAD patients', 'Sixty-eight patients (median 60 years and 69% male) were included', 'patients with left ventricular assist device']","['aggressive nutrition intervention', 'left ventricular assist device (LVAD) implantation']","['serum albumin level', '1-year freedom from adverse events', 'serum albumin levels', 'Serum albumin change', 'death or sepsis', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.183341,"Those with albumin increase >0.7 g/dl had higher 1-year freedom from adverse events (45% vs. 14%, p = .008), dominantly due to lower incidence of death or sepsis compared with those without (p < .05 for both).
","[{'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Imamura', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Combs', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Umar', 'Initials': 'U', 'LastName': 'Siddiqi', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Mirzai', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Stonebraker', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Bullard', 'Affiliation': 'Department of Pharmacy, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Simone', 'Affiliation': 'Department of Pharmacy, University of Chicago Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Valluvan', 'Initials': 'V', 'LastName': 'Jeevanandam', 'Affiliation': 'Department of Surgery, University of Chicago Medical Center, Chicago, Illinois, USA.'}]",Journal of cardiac surgery,['10.1111/jocs.14995']
2991,32939898,High individual pain variability in people living with HIV: a graphical analysis.,"BACKGROUND


People living with HIV (PLWH) frequently experience pain. Following calls to analyze individual-level data in addition to group-level data in pain studies, we compared individual and group-level changes in pain prevalence, intensity and number of pain sites over 48-weeks in a large cohort of PLWH. This is the largest ever cohort study of pain in PLWH, and is the first to report pain at the level of the individual.
METHODS


Participants included all participants with complete pain records from a randomized clinical trial (RCT) for the treatment of HIV (n = 787/1053). At weeks 0, 12, 24, 36 and 48 we assessed participants' pain in the last week; presence of pain, and if present, the intensity and locations of the pain. We used standard averaging methods to describe data at the group-level, and unique graphical reporting methods to analyse data at the level of the individual.
RESULTS


Group-level data demonstrated a trend for pain prevalence to decline over time (19% week 0, 12% week 48). Worst pain intensity remained stable (median between 4/10 and 5/10), as did the number (median = 1) and common sites of pain across the 48 weeks. In contrast, individual-level data demonstrated high intra-individual variability with regards to the presence of pain, and the intensity and location of the pain.
CONCLUSIONS


While our group-level data were similar to previous longitudinal studies, an apparent reduction in pain over 48 weeks, the individual-level data showed large variability within individuals in that same time frame.",2020,"Worst pain intensity remained stable (median between 4/10 and 5/10), as did the number (median = 1) and common sites of pain across the 48 weeks.","['people living with HIV', 'Participants included all participants with complete pain records from a randomized clinical trial (RCT) for the treatment of HIV (n = 787/1053', 'People living with HIV (PLWH) frequently experience pain']",[],"['Worst pain intensity', 'pain prevalence, intensity and number of pain sites', 'pain prevalence', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],"[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",,0.126972,"Worst pain intensity remained stable (median between 4/10 and 5/10), as did the number (median = 1) and common sites of pain across the 48 weeks.","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Wadley', 'Affiliation': 'Brain Function Research Group, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Witwatersrand, South Africa.'}, {'ForeName': 'Wdf', 'Initials': 'W', 'LastName': 'Venter', 'Affiliation': 'Ezintsha Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Serenata', 'Affiliation': 'Ezintsha Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Ezintsha Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mqamelo', 'Affiliation': 'Ezintsha Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Kamerman', 'Affiliation': 'Brain Function Research Group, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Witwatersrand, South Africa.'}]","European journal of pain (London, England)",['10.1002/ejp.1658']
2992,32939904,Hypochlorous acid water prevents postoperative intrauterine infection after microwave endometrial ablation.,"AIM


We investigated the effects of uterine cavity lavage using hypochlorous acid water (HClO) on preventing postoperative intrauterine infection after microwave endometrial ablation (MEA).
METHODS


Four hundred and eleven consecutive patients were enrolled in this study. The patients were divided into two groups: 214 cases in 2014-2016 with disinfection using povidone-iodine antiseptic solution alone (Group A) and 197 cases in 2017-2019 with additional intrauterine douche using HClO (Group B). HClO was used at a concentration of 200 ppm of residual chlorine. One gram of Ceftriaxone Sodium Hydrate was administered by drip infusion during MEA in both groups. Oral antibiotics were administered after MEA only in group A but not in Group B.
RESULTS


Mean patient age (mean ± SD; years old) was 44.5 ± 4.6 in group A and 44.8 ± 5.4 in group B, and mean operation time (min) was 30.4 ± 19.1 in group A and 34.4 ± 22.6 in group B, respectively. Neither were significantly different between groups. The combined ablation techniques i.e. transcervical microwave myolysis and transcervical microwave adenomyolysis did not increase frequency of infection. Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases) (Chi-square test, P = 0.001). Hysterectomy was performed in three severe intrauterine infection cases in group A, but no cases of severe intrauterine infection was found in group B. No adverse effect of HClO was seen.
CONCLUSION


Intrauterine douche using HClO decreases postoperative intrauterine infection after MEA.",2020,Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases),"['patients were divided into two groups: 214 cases in 2014-2016 with', 'after microwave endometrial ablation (MEA', 'Group A) and 197 cases in 2017-2019 with additional intrauterine douche using HClO (Group B', 'Four hundred and eleven consecutive patients were enrolled in this study']","['HClO', 'Oral antibiotics', 'Hypochlorous acid water', 'uterine cavity lavage using hypochlorous acid water (HClO', 'Ceftriaxone Sodium Hydrate', 'disinfection using povidone-iodine antiseptic solution alone']","['Postoperative intrauterine infection cases', 'postoperative intrauterine infection', 'mean operation time', 'adverse effect of HClO', 'severe intrauterine infection', 'frequency of infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0026051', 'cui_str': 'Microwave'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0150554', 'cui_str': 'Douche'}, {'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0700527', 'cui_str': 'Ceftriaxone sodium'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1112157', 'cui_str': 'Intrauterine infection'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0020600', 'cui_str': 'Hypochlorous acid'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",411.0,0.0224565,Postoperative intrauterine infection cases in group B (8 cases) were significantly lower than those in group A (28 cases),"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsuda', 'Affiliation': 'Sanno Ladies Clinic, Akita, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kanaoka', 'Affiliation': 'Department of Gynecology, Iseikai Hospital, Osaka, Japan.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14471']
2993,32939927,"Comment on ""The effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene: A randomized controlled trial"" by Scheerman et al.","It was a great pleasure to read the article by Scheerman and colleagues on the positive effect of using a mobile application for improving oral hygiene in adolescent patients with orthodontic fixed appliances. 1  Their analysis of a prospective randomized controlled study of 132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the control group (CG) without the mHealth program on primary outcomes including the plaque index and gingival index, but not on secondary outcomes of oral health behaviors and psychosocial factors over the 12-week study period. 1  We agree with Scheerman et al. that the mHealth program may contribute to the improvement of oral hygiene in adolescent patients to some extent. However, as a critical evaluation of the work of Scheerman et al. in a comparison with previous studies, 2,3  we have some queries that we hope the authors will address.",2020,"Their analysis of a prospective randomized controlled study of 132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the control group (CG) without the mHealth program on primary outcomes including the plaque index and gingival index, but not on secondary outcomes of oral health behaviors and psychosocial factors over the 12-week study period.","['2,3', 'adolescent patients', 'adolescent patients with orthodontic fixed appliances', '132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the']","['control group (CG) without the mHealth program', 'mobile application (""WhiteTeeth']","['plaque index and gingival index', 'oral hygiene']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]",132.0,0.0255747,"Their analysis of a prospective randomized controlled study of 132 patients revealed the significant superiority of the study group (SG) with the mobile health (mHealth) program compared to the control group (CG) without the mHealth program on primary outcomes including the plaque index and gingival index, but not on secondary outcomes of oral health behaviors and psychosocial factors over the 12-week study period.","[{'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Myoken', 'Affiliation': 'Private Practice Myoken Dental Clinic, Hiroshima, Japan.'}, {'ForeName': 'Myoken', 'Initials': 'M', 'LastName': 'Yoshinari', 'Affiliation': 'Department of Oral Surgery, Hiroshima Red Cross & Atomic-bomb Survivors Hospital, Hiroshima, Japan.'}, {'ForeName': 'Shigeaki', 'Initials': 'S', 'LastName': 'Toratani', 'Affiliation': 'Department of Molecular Oral Medicine and Maxillofacial Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12464']
2994,32940243,Demand for Cancer Screening Services: Results From Randomized Controlled Discrete Choice Experiments.,"OBJECTIVES


Low uptake of cancer screening services is a global concern. Our aim was to understand factors that influence the screening decision, including screening and treatment subsidies and a gain-frame message designed to present screening as a win-win.
METHODS


We analyzed preferences for mammography and Pap smear among women in Singapore by means of discrete choice experiments while randomly exposing half of respondents to a gain-framed public health message promoting the benefits of screening.
RESULTS


Results showed that the message did not influence stated uptake, and given the levels shown, respondents were influenced more by treatment attributes, including effectiveness and out-of-pocket cost should they test positive, than by screening attributes, including the offer of a monetary incentive for screening. Respondents also underestimated the survival chances of screen-detected breast and cervical cancers.
CONCLUSIONS


Combined, these findings suggest that correcting misconceptions about screen-detected cancer prognosis or providing greater financial protection for those who test positive could be more effective and more cost-effective than subsidizing screening directly in increasing screening uptakes.",2020,"RESULTS


Results showed that the message did not influence stated uptake, and given the levels shown, respondents were influenced more by treatment attributes, including effectiveness and out-of-pocket cost should they test positive, than by screening attributes, including the offer of a monetary incentive for screening.",['Cancer Screening Services'],[],['survival chances'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.117165,"RESULTS


Results showed that the message did not influence stated uptake, and given the levels shown, respondents were influenced more by treatment attributes, including effectiveness and out-of-pocket cost should they test positive, than by screening attributes, including the offer of a monetary incentive for screening.","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bilger', 'Affiliation': 'Health Economics and Policy, Vienna University of Economics and Business, Vienna, Austria; Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore. Electronic address: marcel.bilger@wu.ac.at.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Özdemir', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Duke Global Health Institute, Duke University, Durham, NC, USA.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.06.004']
2995,32940257,Parameters of the cardiovascular system in participants of Arctic expeditions.,"OBJECTIVES


A method of continuous heart rate (HR) and blood pressure (BP) recording was used for the evaluation of the cardiovascular system parameters in participants of short-term (<1 month) high-latitude expeditions, in comparison with the parameters of residents of Central Russia and the Arctic region.
MATERIAL AND METHODS


A dynamic examination of participants of Arctic expeditions (30 men, residents of middle-latitude regions, aged 46.7±1.7 years), workers permanently living in Central Russia (the Moscow region, 44 men, aged 46.7±1.0 years) and residents of the North (the Murmansk region, 35 men, aged 46.6±1.3 years) was performed. The authors used a spiroartheriocardiorythmograph allowing the parallel recording of HR, BP, spectral characteristics of HR variability (HRV) and the variability of systolic BP (sBP) and diastolic BP (dBP), cardiac performance parameters, and spontaneous baroreflex sensitivity (BRS). The parameters were recorded at rest, in a sitting position, over 2 min.
RESULTS


The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones. However, the residents of the North demonstrated a lower total power (TP) of the dBP variability spectrum and a lower relative power of the high-frequency (HF) range in both the sBP and dBP variability spectra. The participants of expeditions to the North had a lower TP of the HRV spectrum (in comparison with both control groups) that did not change during the expeditions; BRS was reduced, while the TP of the sBP spectrum was increased in comparison with the corresponding parameters obtained from the residents of circumpolar regions, and decreased during the expedition in parallel with a decrease in the sBP values. The TP of both the sBP and dBP variability spectra, as well as the power of the HF range in these spectra, were similar in the participants of expeditions to those obtained from the residents of Central Russia, and they considerably surpassed the corresponding parameters in the northerners surveyed.
CONCLUSIONS


The revealed peculiarities of the cardiovascular system in the participants of high-latitude expeditions can be considered as correlates of positive, and adequate in terms of the physiological value, adaptive shifts in the autonomous regulation of the cardiovascular system.",2020,"The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones.","['participants of short-term (<1 month) high-latitude expeditions, in comparison with the parameters of residents of Central Russia and the Arctic region', 'participants of Arctic expeditions', 'participants of Arctic expeditions (30 men, residents of middle-latitude regions, aged 46.7±1.7 years), workers permanently living in Central Russia (the Moscow region, 44 men, aged 46.7±1.0 years) and residents of the North (the Murmansk region, 35 men, aged 46.6±1.3 years']",[],"['TP of the sBP spectrum', 'HR, BP, spectral characteristics of HR variability (HRV) and the variability of systolic BP (sBP) and diastolic BP (dBP), cardiac performance parameters, and spontaneous baroreflex sensitivity (BRS', 'lower TP of the HRV spectrum', 'lower total power (TP) of the dBP variability spectrum', 'sBP values', 'basic clinical parameters (HR, BP and cardiac performance', 'continuous heart rate (HR) and blood pressure (BP']","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015315', 'cui_str': 'Expeditions'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0003740', 'cui_str': 'Arctic Regions'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",44.0,0.0311069,"The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones.","[{'ForeName': 'Nataliya B', 'Initials': 'NB', 'LastName': 'Pankova', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Irina B', 'Initials': 'IB', 'LastName': 'Alchinova', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Anton B', 'Initials': 'AB', 'LastName': 'Cherepov', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Elena N', 'Initials': 'EN', 'LastName': 'Yakovenko', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Mikhail Y', 'Initials': 'MY', 'LastName': 'Karganov', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}]",International journal of occupational medicine and environmental health,['10.13075/ijomeh.1896.01628']
2996,32940336,Positive Effect of Helicobacter pylori Treatment on Outcome of Patients With Chronic Spontaneous Urticaria.,"OBJECTIVES


The association between Helicobacter pylori and chronic spontaneous urticaria (CSU) is controversial. Therefore, we aimed to directly diagnose H pylori by polymerase chain reaction (PCR) in gastric tissue from patients with CSU and to investigate the association between H pylori eradication therapy and CSU remission.
METHODS


Twenty-seven of 72 patients with CSU who were positive for H pylori stool antigen and PCR in gastric biopsy specimens were randomized to receive either anti-H pylori treatment or placebo.
RESULTS


Patients with H pylori were found to have significantly lower hemoglobin concentrations with microcytic hypochromic anemia and a significantly higher occurrence of dyspepsia symptoms. All H pylori-treated patients (except two) showed significant improvement of the urticaria itching and red wheals after 2 weeks of therapy compared with the placebo group (P < .001). The response rate to treatment was 85.7% (12 patients; 95% confidence interval, 64.3%-100.0%). The two patients who failed to eradicate H pylori had an H pylori strain resistant to amoxicillin.
CONCLUSIONS


An association was observed between CSU and presence of H pylori infection in the gastric tissue. Whether this is a causal relationship or not remains to be discovered, but treatment of H pylori can significantly improve the symptoms of CSU.",2020,"The response rate to treatment was 85.7% (12 patients; 95% confidence interval, 64.3%-100.0%).","['Patients With Chronic Spontaneous Urticaria', 'two patients who failed to eradicate H pylori had an H pylori strain resistant to amoxicillin', 'Twenty-seven of 72 patients with CSU who were positive for H pylori stool antigen and PCR in gastric biopsy specimens']","['Helicobacter pylori Treatment', 'placebo', 'anti-H pylori treatment or placebo']","['urticaria itching and red wheals', 'dyspepsia symptoms', 'hemoglobin concentrations with microcytic hypochromic anemia', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0192420', 'cui_str': 'Biopsy of stomach'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0221137', 'cui_str': 'Blood group antibody H'}]","[{'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0221232', 'cui_str': 'Weal'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0271901', 'cui_str': 'Microcytic hypochromic anemia'}]",72.0,0.0565833,"The response rate to treatment was 85.7% (12 patients; 95% confidence interval, 64.3%-100.0%).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Elhendawy', 'Affiliation': 'Tropical Medicine and Infectious Diseases Department, Tanta, Egypt.'}, {'ForeName': 'Maha M', 'Initials': 'MM', 'LastName': 'Hagras', 'Affiliation': 'Clinical Pathology Department, Tanta, Egypt.'}, {'ForeName': 'Shaimaa S', 'Initials': 'SS', 'LastName': 'Soliman', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Engi Seif E', 'Initials': 'ESE', 'LastName': 'Shaker', 'Affiliation': 'Public Health and Community Medicine Department, Faculty of Medicine, Menoufia University, Shebin Elkom, Egypt.'}]",American journal of clinical pathology,['10.1093/ajcp/aqaa134']
2997,32940343,Efficacy and safety of ixekizumab after switching from fumaric acid esters or methotrexate in patients with moderate-to-severe plaque psoriasis naïve to systemic treatment.,"Psoriasis is a chronic inflammatory skin disorder, which, in cases of moderate-to-severe disease, requires long-term systemic therapy. 1  For patients with an inadequate response or intolerance to a specific systemic therapy, switching psoriasis treatments is a common practice that may improve outcomes. Switching from conventional to biologic therapies is of particular interest, but few head-to-head trials have been performed. 2  The first head-to-head, prospective, randomised trial comparing fumaric acid esters (FAE) and methotrexate, two commonly used first-line conventional systemic agents, and an interleukin (IL)-17A antagonist, ixekizumab, was published recently.",2020,"The first head-to-head, prospective, randomised trial comparing fumaric acid esters (FAE) and methotrexate, two commonly used first-line conventional systemic agents, and an interleukin (IL)-17A antagonist, ixekizumab, was published recently.",['patients with moderate-to-severe plaque psoriasis naïve to systemic treatment'],"['methotrexate', 'ixekizumab', 'fumaric acid esters (FAE) and methotrexate']",['Efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2.0,0.0671474,"The first head-to-head, prospective, randomised trial comparing fumaric acid esters (FAE) and methotrexate, two commonly used first-line conventional systemic agents, and an interleukin (IL)-17A antagonist, ixekizumab, was published recently.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Leutz', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'University Clinic of Frankfurt am Main, Department of Dermatology, Venereology and Allergology, Frankfurt am Main, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center Inflammation Medicine, University zu Lübeck, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schuster', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fotiou', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Hundemer', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saure', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19558']
2998,32940404,"The beneficial effects of sumac (Rhus coriaria L.) supplementation along with restricted calorie diet on anthropometric indices, oxidative stress, and inflammation in overweight or obese women with depression: A randomized clinical trial.","BACKGROUND


Oxidative stress and inflammation play pivotal roles in the pathophysiology of obesity and depression. This study aimed to evaluate the effects of sumac (Rhus coriaria L.) on anthropometric indices, oxidative stress, inflammation, and depression in overweight or obese depressed women.
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted on overweight or obese women aged 20-65 years with mild to moderate depression. The participants (n = 62) were assigned to receive a restricted calorie diet (RCD) plus 3 g/day of either sumac or placebo for 12 weeks. Anthropometric measurements, biochemical biomarkers, and the Beck depression inventory were assessed during the study.
RESULTS


Sumac significantly reduced weight, body mass index, body fat (p < .001), visceral fat level (p = .03), waist and hip circumference, and malondialdehyde levels (p = .03, p = .002, and p = .006, respectively) in comparison with the placebo group. The levels of interleukin-6 and tumor necrosis factor-α decreased only in the sumac group (11 and 32%, respectively); however, these reductions were not significant. The high-sensitivity c-reactive protein levels (p = .007 and p = .01, respectively) and Beck scores (p < .001) decreased significantly in both the sumac and the placebo group without any significant difference between the two groups.
CONCLUSION


Sumac can be considered as a functional food that along with RCD could have beneficial effects on obesity management, through the possible modulatory effects on oxidative stress in overweight or obese depressed women.",2020,"The high-sensitivity c-reactive protein levels (p = .007 and p = .01, respectively) and Beck scores (p < .001) decreased significantly in both the sumac and the placebo group without any significant difference between the two groups.
","['participants (n =\u200962', 'overweight or obese depressed women', 'overweight or obese women with depression', 'overweight or obese women aged 20-65\u2009years with mild to moderate depression']","['sumac (Rhus coriaria L.) supplementation', 'placebo', 'sumac (Rhus coriaria L', 'restricted calorie diet (RCD) plus 3\u2009g/day of either sumac or placebo']","['weight, body mass index, body fat ', 'Anthropometric measurements, biochemical biomarkers, and the Beck depression inventory', 'anthropometric indices, oxidative stress, inflammation, and depression', 'waist and hip circumference, and malondialdehyde levels', 'high-sensitivity c-reactive protein levels', 'visceral fat level', 'oxidative stress', 'anthropometric indices, oxidative stress, and inflammation', 'levels of interleukin-6 and tumor necrosis factor-α', 'Beck scores']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0330866', 'cui_str': 'Coriaria'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.473491,"The high-sensitivity c-reactive protein levels (p = .007 and p = .01, respectively) and Beck scores (p < .001) decreased significantly in both the sumac and the placebo group without any significant difference between the two groups.
","[{'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Hariri', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Darafshi Ghahroudi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Siroos', 'Initials': 'S', 'LastName': 'Jahangiri', 'Affiliation': 'Social Security Organization, Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Borumandnia', 'Affiliation': 'Department of Basic Science, Faculty of Paramedical Sciences, Shahid Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Narmaki', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atoosa', 'Initials': 'A', 'LastName': 'Saidpour', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6737']
2999,32945777,Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial.,"BACKGROUND


Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
OBJECTIVE


This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation.
METHODS


The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records.
RESULTS


We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app.
CONCLUSIONS


This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19288.",2020,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","['Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation', 'Cancer patients who undergo allogeneic hematopoietic stem cell transplantation', '166 family caregiver-patient dyads for the full data analysis', 'family caregivers of patients undergoing hematopoietic stem cell transplantation']",['positive psychology intervention arm with a control arm in family caregiver-patient dyads'],"['objective physiological markers (eg, sleep, activity, heart rate', 'caregiver health-related quality of life', 'caregiver health-related quality of life, as assessed by the PROMIS Global Health scale', 'PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.40449,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozwadowski', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Manasa', 'Initials': 'M', 'LastName': 'Dittakavi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazzoli', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Afton L', 'Initials': 'AL', 'LastName': 'Hassett', 'Affiliation': 'Department of Anesthesia, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Barton', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Carlozzi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Muneesh', 'Initials': 'M', 'LastName': 'Tewari', 'Affiliation': 'Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hanauer', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/19288']
3000,32945860,"Gender differences in the effect of gamification on weight loss during a daily, neurocognitive training program.","A major contributor to the obesity epidemic is the overconsumption of high-calorie foods, which is partly governed by inhibitory control, that is, the ability to override pre-prepotent impulses and drives. Computerized inhibitory control trainings (ICTs) have demonstrated qualified success at affecting real-world health behaviors, and at improving weight loss, particularly when repeated frequently over an extended duration. It has been proposed that gamification (i.e., incorporating game-like elements such as a storyline, sounds, graphics, and rewards) might enhance participant interest and thus training compliance. Previous findings from a mostly female sample did support this hypothesis; however, it might be expected that the effects of gamification differ by gender such that men, who appear more motivated by gaming elements, stand to benefit more from gamification. The present study evaluated whether gender moderated the effect of a gamified ICT on weight loss. Seventy-six overweight individuals received a no-sugar-added dietary prescription and were randomized to 42 daily and 2 weekly ICTs focused on sweet foods that were either gamified or nongamified. Results supported the hypothesis that gamification elements had a positive effect on weight loss for men and not women (p = .03). However, mechanistic hypotheses for the moderating effect (in terms of enjoyment, compliance, and improvements in inhibitory control) were generally not supported (p's > .20). These results suggest that gamification of ICTs may boost weight loss outcomes for men and not women, but further research is needed to determine the specific mechanisms driving this effect and to arrive at gamification elements that enhance effects for both men and women.",2020,Results supported the hypothesis that gamification elements had a positive effect on weight loss for men and not women (p = .03).,['Seventy-six overweight individuals'],"['ICTs focused on sweet foods that were either gamified or nongamified', 'no-sugar-added dietary prescription', 'gamified ICT', 'Computerized inhibitory control trainings (ICTs']",['weight loss'],"[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0453865', 'cui_str': 'Sweet food'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",76.0,0.0251556,Results supported the hypothesis that gamification elements had a positive effect on weight loss for men and not women (p = .03).,"[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Diane H', 'Initials': 'DH', 'LastName': 'Dallal', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Crochiere', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Berry', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Sciences (WELL Center), Drexel University, Philadelphia, PA, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa091']
3001,32945875,Effect of 2 Integrated Interventions on Alcohol Abstinence and Viral Suppression Among Vietnamese Adults With Hazardous Alcohol Use and HIV: A Randomized Clinical Trial.,"Importance


Hazardous and heavy alcohol use is common among people living with HIV and may decrease antiretroviral therapy (ART) adherence, but limited data exist from randomized clinical trials about the effects of interventions on viral load.
Objective


To compare the efficacy of 2 scalable ART clinic-based interventions on alcohol use and viral suppression.
Design, Setting, and Participants


This 3-group randomized clinical trial was conducted among 440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam. Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included. Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020.
Interventions


Participants were randomly assigned (1:1:1) to standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions.
Main Outcomes and Measures


The primary study outcomes were percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression at 12 months after enrollment.
Results


A total of 440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4%) were assigned to the combined intervention, 147 (33.4%) to the brief intervention, and 146 (33.2%) to SOC. In the combined intervention group, 112 participants (76.2%) attended all 6 sessions, and in the brief intervention group, 124 (84.4%) attended all 4 sessions; in the whole sample, 390 (88.6%) completed 12 months of follow-up. At 12 months, the mean (SE) percentage of days abstinent was 65% (3.1%) among those in the combined intervention group, 65% (3.2%) among those in the brief intervention group, and 50% (3.4%) among those in the in the SOC group (Cohen d for combined intervention vs SOC and brief intervention vs SOC: 39%; 95% CI, 15% to 64%). Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
Conclusions and Relevance


In this study, the brief intervention resulted in a significant increase in percentage of days abstinent from alcohol and a significant increase in viral suppression after 12 months. Future implementation science studies evaluating scale-up of the brief intervention are needed.
Trial Registration


ClinicalTrials.gov Identifier: NCT02720237.",2020,"Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
","['Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included', '440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam', 'Vietnamese Adults With Hazardous Alcohol Use and HIV', '440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4', 'people living with HIV', 'Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020']","['2 Integrated Interventions', 'standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions']","['Viral suppression', 'Alcohol Abstinence and Viral Suppression', 'viral suppression', 'percentage of days abstinent from alcohol', 'mean (SE) percentage of days abstinent', 'percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C4706350', 'cui_str': 'AUDIT-C (Alcohol Use Disorders Identification Test - Consumption) score'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0070787', 'cui_str': 'Phosphatidylethanol'}]",440.0,0.0729123,"Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
","[{'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Tran V', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Nguyen V T', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'Vinmec Healthcare System, Hanoi, Vietnam.'}, {'ForeName': 'Bui X', 'Initials': 'BX', 'LastName': 'Quynh', 'Affiliation': 'University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Vu', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Blackburn', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.17115']
3002,32945898,"Insulin resistance induced by growth hormone is linked to lipolysis and associated with suppressed pyruvate dehydrogenase activity in skeletal muscle: a 2 × 2 factorial, randomised, crossover study in human individuals.","AIMS/HYPOTHESIS


Growth hormone (GH) causes insulin resistance that is linked to lipolysis, but the underlying mechanisms are unclear. We investigated if GH-induced insulin resistance in skeletal muscle involves accumulation of diacylglycerol (DAG) and ceramide as well as impaired insulin signalling, or substrate competition between fatty acids and glucose.
METHODS


Nine GH-deficient male participants were randomised and examined in a 2 × 2 factorial design with and without administration of GH and acipimox (an anti-lipolytic compound). As-treated analyses were performed, wherefore data from three visits from two patients were excluded due to incorrect GH administration. The primary outcome was insulin sensitivity, expressed as the AUC of the glucose infusion rate (GIR AUC ), and furthermore, the levels of DAGs and ceramides, insulin signalling and the activity of the active form of pyruvate dehydrogenase (PDHa) were assessed in skeletal muscle biopsies obtained in the basal state and during a hyperinsulinaemic-euglycaemic clamp (HEC).
RESULTS


Co-administration of acipimox completely suppressed the GH-induced elevation in serum levels of NEFA (GH versus GH+acipimox, p < 0.0001) and abrogated GH-induced insulin resistance (mean GIR AUC  [95% CI] [mg min -1  kg -1 ] during the HEC: control, 595 [493, 718]; GH, 468 [382, 573]; GH+acipimox, 654 [539, 794]; acipimox, 754 [618, 921]; GH vs GH+acipimox: p = 0.004). GH did not significantly change either the accumulation of DAGs and ceramides or insulin signalling in skeletal muscle, but GH antagonised the insulin-stimulated increase in PDHa activity (mean ± SEM [% from the basal state to the HEC]: control, 47 ± 19; GH, -15 ± 21; GH+acipimox, 3 ± 21; acipimox, 57 ± 22; main effect: p = 0.02).
CONCLUSIONS/INTERPRETATION


GH-induced insulin resistance in skeletal muscle is: (1) causally linked to lipolysis; (2) not associated with either accumulation of DAGs and ceramides or impaired insulin signalling; (3) likely to involve substrate competition between glucose and lipid intermediates.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02782208 FUNDING: The work was supported by the Grant for Growth Innovation (GGI), which was funded by Merck KGaA, Darmstadt, Germany. Graphical abstract.",2020,"GH did not significantly change either the accumulation of DAGs and ceramides or insulin signalling in skeletal muscle, but GH antagonised the insulin-stimulated increase in PDHa activity (mean ± SEM [% from the basal state to the HEC]: control, 47 ± 19; GH, -15 ± 21; GH+acipimox, 3 ± 21; acipimox, 57 ± 22; main effect: p = 0.02).
","['human individuals', 'Nine GH-deficient male participants']","['acipimox', 'GH and acipimox']","['insulin sensitivity, expressed as the AUC of the glucose infusion rate (GIR AUC ), and furthermore, the levels of DAGs and ceramides, insulin signalling and the activity of the active form of pyruvate dehydrogenase (PDHa', 'abrogated GH-induced insulin resistance', 'accumulation of DAGs and ceramides or insulin signalling in skeletal muscle', 'GH-induced elevation in serum levels of NEFA', 'PDHa activity', 'skeletal muscle biopsies obtained in the basal state and during a hyperinsulinaemic-euglycaemic clamp (HEC']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0050558', 'cui_str': 'acipimox'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011967', 'cui_str': '1,2,5,6-Dianhydrogalactitol'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0072792', 'cui_str': 'Pyruvate dehydrogenase (lipoamide)'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C2315740', 'cui_str': 'Biopsy of skeletal muscle'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}]",,0.162835,"GH did not significantly change either the accumulation of DAGs and ceramides or insulin signalling in skeletal muscle, but GH antagonised the insulin-stimulated increase in PDHa activity (mean ± SEM [% from the basal state to the HEC]: control, 47 ± 19; GH, -15 ± 21; GH+acipimox, 3 ± 21; acipimox, 57 ± 22; main effect: p = 0.02).
","[{'ForeName': 'Astrid J', 'Initials': 'AJ', 'LastName': 'Hjelholt', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark. ajh@clin.au.dk.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Charidemou', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Julian L', 'Initials': 'JL', 'LastName': 'Griffin', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Steen B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gudiksen', 'Affiliation': 'Section for Cell Biology and Physiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Pilegaard', 'Affiliation': 'Section for Cell Biology and Physiology, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Jens O L', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N, Denmark.'}]",Diabetologia,['10.1007/s00125-020-05262-w']
3003,32945926,[Treatment of asymptomatic aortic stenosis : RECOVERY trial (randomized comparison of early surgery versus conventional treatment in very severe aortic stenosis)].,,2020,,"['asymptomatic aortic stenosis ', 'very severe aortic stenosis']",['early surgery versus conventional treatment'],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0233211,,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kutschka', 'Affiliation': 'Klinik für Thorax‑, Herz- und Gefäßchirurgie, Universitätsmedizin Göttingen, Georg-August-Universität, Robert-Koch-Str.\xa040, 37075, Göttingen, Deutschland. ingo.kutschka@med.uni-goettingen.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nitschmann', 'Affiliation': ', Lippetal, Deutschland.'}]",Der Internist,['10.1007/s00108-020-00868-z']
3004,32945947,Morphometric parameters of muscle and bone in critically ill patients : Post hoc analysis of the VITdAL-ICU trial.,"BACKGROUND


Sarcopenia, defined as loss of muscle mass, quality and function, is a part of the frailty syndrome. In critical illness, sarcopenia has rarely been evaluated regarding clinical outcomes. Therefore, we evaluated the association of sarcopenia with both hospital length of stay (HLOS) and 6‑month mortality in critically ill patients using abdominal computed tomography (CT) scans.
METHODS


In a post hoc analysis from the high dose vitamin D3 vs. placebo in adult vitamin D deficient patients (VITdAL-ICU) trial, we retrospectively reviewed all available abdominal CT scans (18 women, 19 men). We measured and calculated total psoas area (TPA), psoas muscle density (PMD), skeletal muscle index (SMI) and bone mineral density (BMD) and analyzed the relation of these endpoints with HLOS and mortality. Defining sarcopenia we used cut-off values for TPA as 642.1 mm 2 /m 2  in women and 784 mm 2 /m 2  in men and PMD as 31.1 Hounsfield units (HU) in women and 33.3 HU in men, both measured at the level of L3, as well as for SMI (38.5 cm 2 /m 2  in women and 52.4 cm 2 /m 2  in men). Likely osteoporosis was defined by L1 trabecular attenuation of ≤110 HU. Values for TPA, PMD and SMI could not be obtained in 11 patients and BMD in 1 patient.
RESULTS


Mean adjusted TPA was lower in women versus men (478 vs. 749 mm 2 /m 2 ) as well as PMD (34.6 vs. 41.3 HU), SMI (62.36 vs. 76.81 cm 2 /m 2 ) and BMD (141.1 vs. 157.2 HU). No significant influence on hospital length of stay and on 6‑month mortality was found, irrespective of the morphometric parameter used (TPA, PMD, SMI, BMD; p > 0.05). Survivors showed statistically nonsignificantly better values than nonsurvivors: TPA: 652 vs. 530 mm 2 /m 2  (p = 0.27); PMD: 38.4 vs. 37.4 HU (p = 0.85); SMI: 70.32 vs. 69.54 cm 2 /m 2  (p = 0.91); BMD: 156 vs. 145.8 HU (p = 0.81).
CONCLUSION


Although the study is limited by the small sample size, our data do not support a strong predictive value for TPA/PMD/SMI or BMD for HLOS or mortality in critically ill patients with vitamin D deficiency.",2020,"No significant influence on hospital length of stay and on 6‑month mortality was found, irrespective of the morphometric parameter used (TPA, PMD, SMI, BMD; p > 0.05).","['adult vitamin', 'critically ill patients with vitamin\xa0D deficiency', 'critically ill patients using abdominal computed tomography (CT) scans', 'critically ill patients ', 'D deficient patients (VITdAL-ICU) trial, we retrospectively reviewed all available abdominal CT scans (18\xa0women, 19\xa0men']","['vitamin D3 vs. placebo', 'nonsurvivors', 'TPA']","['Values for TPA, PMD and SMI', 'Mean adjusted TPA', 'calculated total psoas area (TPA), psoas muscle density (PMD), skeletal muscle index (SMI) and bone mineral density (BMD', 'sarcopenia with both hospital length of stay (HLOS) and 6‑month mortality', 'hospital length of stay and on 6‑month mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0085221', 'cui_str': 'Structure of psoas muscle'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.138753,"No significant influence on hospital length of stay and on 6‑month mortality was found, irrespective of the morphometric parameter used (TPA, PMD, SMI, BMD; p > 0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Malle', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria. o.malle@gmx.at.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Maurer', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Wagner', 'Affiliation': 'Department of Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schnedl', 'Affiliation': 'Department of Interventional and Diagnostic Radiology, General Hospital of Klagenfurt, Graz, Austria.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Amrein', 'Affiliation': 'Department of Anesthesiology, Elisabethinen Hospital, Graz, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Fahrleitner-Pammer', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Hans Peter', 'Initials': 'HP', 'LastName': 'Dimai', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Amrein', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01736-4']
3005,32945993,Rare genetic variants suggest dysregulation of signaling pathways in low- and high-risk patients developing severe ovarian hyperstimulation syndrome.,"PURPOSE


To investigate if rare gene variants in women with severe ovarian hyperstimulation syndrome (OHSS) provide clues to the mechanisms involved in the syndrome.
METHODS


Among participants in a prospective randomized study (Toftager et al. 2016), six women with predicted low and six women with predicted high risk of OHSS developing severe OHSS (grades 4 and 5, Golan classification) were selected. In the same cohort, six plus six matched controls developing no signs of OHSS (Golan grade 0) were selected. Whole-exome sequencing was performed. Analysis using a predefined in silico OHSS gene panel, variant filtering, and pathway analyses was done.
RESULTS


We found no convincing monogenetic association with the development of OHSS using the in silico gene panel. Pathway analysis of OHSS variant lists showed substantial overlap in highly enriched top pathways (p value range p < 0.0001 and p > 9.8E-17) between the low- and high-risk group developing severe OHSS, i.e., ""the integrin-linked kinase (ILK) signaling pathway"" and the ""axonal guidance signaling pathway,"" both being connected to vasoactive endothelial growth factor (VEGF) and endothelial function.
CONCLUSION


Rare variants in OHSS cases with two distinct risk profiles enrich the same signaling pathways linked to VEGF and endothelial function. Clarification of the mechanism as well as potentially defining genetic predisposition of the high vascular permeability is important for future targeted treatment and prevention of OHSS; the potential roles of ILK signaling and the axonal guidance signaling need to be validated by functional studies.",2020,"Pathway analysis of OHSS variant lists showed substantial overlap in highly enriched top pathways (p value range p < 0.0001 and p > 9.8E-17) between the low- and high-risk group developing severe OHSS, i.e., ""the integrin-linked kinase (ILK) signaling pathway"" and the ""axonal guidance signaling pathway,"" both being connected to vasoactive endothelial growth factor (VEGF) and endothelial function.
","['women with severe ovarian hyperstimulation syndrome (OHSS', '2016), six women with predicted low and six women with predicted high risk of OHSS developing severe OHSS (grades 4 and 5, Golan classification) were selected']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",[],[],6.0,0.0363445,"Pathway analysis of OHSS variant lists showed substantial overlap in highly enriched top pathways (p value range p < 0.0001 and p > 9.8E-17) between the low- and high-risk group developing severe OHSS, i.e., ""the integrin-linked kinase (ILK) signaling pathway"" and the ""axonal guidance signaling pathway,"" both being connected to vasoactive endothelial growth factor (VEGF) and endothelial function.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Borgwardt', 'Affiliation': 'Centre for Genomic Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. Line.gutte.borgwardt@regionh.dk.'}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Olsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rossing', 'Affiliation': 'Centre for Genomic Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'R Borup', 'Initials': 'RB', 'LastName': 'Helweg-Larsen', 'Affiliation': 'Functional Genomics and Reproductive Health Group, Faculty of Health and Medical Sciences- Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toftager', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Grøndahl', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital, Herlev, Denmark.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-01941-0']
3006,32946039,Wake-Promoting Effect of Bloodletting Puncture at Hand Twelve Jing-Well Points in Acute Stroke Patients: A Multi-center Randomized Controlled Trial.,"OBJECTIVE


To assess the effect and safety of bloodletting puncture at hand twelve Jing-Well points (HTWPs) in acute stroke patients with conscious disturbance.
METHODS


In this multi-center and randomized controlled trial, 360 patients suffered from ischemic or hemorrhagic stroke with conscious disturbance within 48 h from the onset of symptom were divided into bloodletting (180 cases) and control (180 cases) groups using a block randomization. Patients in both groups received routine Western medicine, and patients in the bloodletting group received additional bloodletting puncture at HTWPs on admission immediately before conventional treatment. The primary outcome measure was Glasgow Coma Scale (GCS) score and the secondary outcomes included blood pressure, respiratory rate and pulse rate. All variables were evaluated at baseline (before bloodletting), 0 (after bloodletting immediately), 15, 30, 50 and 80 min post bloodletting.
RESULTS


At 80 min post bloodletting, the proportion of patients with improved consciousness in the bloodletting group was greater than the control group (P<0.05). In the separate analysis of moderate consciousness disturbance subgroup, bloodletting therapy benefited ischemic patients, and improved the eye and language response of GCS score at 15, 30, 50, 80 min post bloodletting (P<0.05 or P<0.01). No significant differences were observed regarding the secondary outcomes between two groups (P>0.05).
CONCLUSION


The bloodletting puncture at HTWPs was safe and could improve conscious levels of ischemic stroke patients, highlighting a first-aid intervention for acute stroke. (Registration No. ChiCTR-INR-16009530).",2020,"At 80 min post bloodletting, the proportion of patients with improved consciousness in the bloodletting group was greater than the control group (P<0.05).","['acute stroke patients with conscious disturbance', 'Acute Stroke Patients', '360 patients suffered from ischemic or hemorrhagic stroke with conscious disturbance within 48 h from the onset of symptom were divided into bloodletting (180 cases) and control (180 cases) groups using a block randomization']","['bloodletting puncture at hand twelve Jing-Well points (HTWPs', 'routine Western medicine', 'Bloodletting Puncture at Hand', 'bloodletting group received additional bloodletting puncture at HTWPs']","['eye and language response of GCS score', 'proportion of patients with improved consciousness', 'Glasgow Coma Scale (GCS) score', 'blood pressure, respiratory rate and pulse rate']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",360.0,0.159877,"At 80 min post bloodletting, the proportion of patients with improved consciousness in the bloodletting group was greater than the control group (P<0.05).","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Yu', 'Affiliation': ""Department of Traditional Chinese Medicine, Xijing Hospital, the Air Force Medical University, Xi'an, 710032, China.""}, {'ForeName': 'Zhi-Fang', 'Initials': 'ZF', 'LastName': 'Xu', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Acupuncture and Moxibustion, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.'}, {'ForeName': 'Zhi-Liang', 'Initials': 'ZL', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture and Moxibustion, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300150, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Zhen-Guo', 'Initials': 'ZG', 'LastName': 'Wang', 'Affiliation': ""The Third Department of Encephalopathy, Xi'an Encephalopathy Hospital of Traditional Chinese Medicine, Xi'an, 710032, China.""}, {'ForeName': 'Ze-Lin', 'Initials': 'ZL', 'LastName': 'Chen', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China.'}, {'ForeName': 'Xing-Fang', 'Initials': 'XF', 'LastName': 'Pan', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China. panxingfang@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Acupuncture Research Center, Tianjin University of traditional Chinese Medicine, Tianjin, 301617, China. guoyi_2016@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3093-8']
3007,32946077,Dihydrotestosterone (DHT) rapidly increase after maximal aerobic exercise in healthy males: the lowering effect of phosphodiesterase's type 5 inhibitors on DHT response to exercise-related stress.,"PURPOSE


Few data exist on dihydrotestosterone (DHT) adaptation to exercise-related stress. The aim of the study was to investigate on serum DHT and other androgens' responses to acute aerobic exercises, and to verify if a long-acting phosphodiesterase's type 5 inhibitors could influence these responses, as previously observed for salivary testosterone.
METHODS


In a double-blind cross over study, 12 healthy trained male volunteers were submitted to both an acute sub-maximal and maximal exercise tests on cycle ergometer, after randomly receiving a two days placebo or tadalafil administration (20 mg, Cialis ® , Ely-Lilly, Indianapolis, IN, USA). Blood sample collections were performed at different time points before and after exercise. Serum DHT, total testosterone (TT), dehydroepiandrosterone sulfate (DHEAS) and luteinizing hormone (LH), were assayed.
RESULTS


Serum DHT increase in placebo treatment immediately post maximal aerobic exercise and return to basal values at 60 min of recovery whereas tadalafil administration significantly reduced the DHT increase after exercise. The values of areas under curves showed the increase of TT after acute sub-maximal and maximal exercise and of DHEAS only after acute maximal aerobic exercise independently from treatment.
CONCLUSIONS


In addition to testosterone, also DHT plays an exercise-related adaptive role during high intensity aerobic exercise, but its rapid useful effects during exercise have to be determined. We hypothesized that the increased androgens secretion during exercise could be mainly related to steroidogenic enzymes modifications in peripheral tissues (i.e., muscles). Moreover, the blunting effect of tadalafil on DHT increase support a possible role of peripheral nitric oxide/GMPc related pathways in influencing physical-stress related DHT metabolism.",2020,"The values of areas under curves showed the increase of TT after acute sub-maximal and maximal exercise and of DHEAS only after acute maximal aerobic exercise independently from treatment.
","['12 healthy trained male volunteers', 'healthy males']","['testosterone', 'dihydrotestosterone (DHT', 'tadalafil', 'acute sub-maximal and maximal exercise tests on cycle ergometer', 'placebo', 'placebo or tadalafil administration (20\xa0mg, Cialis ® , Ely-Lilly, Indianapolis, IN, USA', 'Dihydrotestosterone (DHT']","['maximal aerobic exercise and return to basal values', 'androgens secretion', 'Serum DHT, total testosterone (TT), dehydroepiandrosterone sulfate (DHEAS) and luteinizing hormone (LH']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0038148', 'cui_str': 'androstanolone'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038148', 'cui_str': 'androstanolone'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",12.0,0.093268,"The values of areas under curves showed the increase of TT after acute sub-maximal and maximal exercise and of DHEAS only after acute maximal aerobic exercise independently from treatment.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sgrò', 'Affiliation': 'Unit of Endocrinology, Department of Movement, Human and Health Sciences, Università degli Studi di Roma ""Foro Italico"", Piazza Lauro de Bosis 15, 00135, Roma, Italy. paolo.sgro@uniroma4.it.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Minganti', 'Affiliation': 'Unit of Sport Medicine, Department of Movement, Human and Health Sciences, Università degli Studi di Roma ""Foro Italico"", Roma, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lista', 'Affiliation': 'Unit of Endocrinology, Department of Movement, Human and Health Sciences, Università degli Studi di Roma ""Foro Italico"", Piazza Lauro de Bosis 15, 00135, Roma, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Antinozzi', 'Affiliation': 'Unit of Endocrinology, Department of Movement, Human and Health Sciences, Università degli Studi di Roma ""Foro Italico"", Piazza Lauro de Bosis 15, 00135, Roma, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cappa', 'Affiliation': ""Unit of Endocrinology, Bambino Gesù Children's Hospital, Roma, Italy.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Pitsiladis', 'Affiliation': 'Collaborating Centre of Sports Medicine, University of Brighton, Welkin House, Eastbourne, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pigozzi', 'Affiliation': 'Unit of Sport Medicine, Department of Movement, Human and Health Sciences, Università degli Studi di Roma ""Foro Italico"", Roma, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Luigi', 'Affiliation': 'Unit of Endocrinology, Department of Movement, Human and Health Sciences, Università degli Studi di Roma ""Foro Italico"", Piazza Lauro de Bosis 15, 00135, Roma, Italy.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01409-z']
3008,32946086,Management of thoracolumbar injury classification and severity score of 4 (TLICS=4) thoracolumbar vertebra fractures: Surgery versus conservative treatment.,"BACKGROUND


This study aims to compare clinical and radiographic outcomes of surgical treatment and conservative treatment with bracing in neurologically intact patients with score 4 of TLICS thoracolumbar vertebra fractures.
METHODS


Patients with traumatic thoracolumbar junction fractures (T11-L2), the score of TLICS 4, and minimum 24-month follow-up were included in this study. Patients were divided into surgery and bracing groups. The groups were compared concerning clinical and demographical features, local kyphotic angles (LKA), vertebra height loss percentage (VHL), Oswestry Disability Index (ODI), Visual Analog Scale (VAS) and time to return to work.
RESULTS


There were 74 patients (71 males, 3 females) in the surgery group and 76 patients (58 males, 18 females) in the bracing group. Although the surgery group showed better improvement in VAS scores within six months postoperatively, no significant difference was observed at the 24th-month evaluation (p<0.001 and p=0.270, respectively). ODI, LKA and VHL were significantly lower in the surgery group (p<0.001, p<0.001 and p<0.001, respectively). In addition, return to work was significantly earlier in the surgery group (p<0.001).
CONCLUSION


The findings obtained in this study suggest that the surgical treatment for TLICS 4 patients with thoracolumbar fractures has better clinical and radiographic outcomes than the bracing. Moreover, returning time to the work of patients is shortened with surgical treatment. The surgical treatment seems to be the first and the appropriate choice in the management of TLICS 4 thoracolumbar vertebral fractures.",2020,"ODI, LKA and VHL were significantly lower in the surgery group (p<0.001, p<0.001 and p<0.001, respectively).","['74 patients (71 males, 3 females) in the surgery group and 76 patients (58 males, 18 females) in the bracing group', 'neurologically intact patients with score 4 of TLICS thoracolumbar vertebra fractures', 'Patients with traumatic thoracolumbar junction fractures (T11-L2), the score of TLICS 4, and minimum 24-month follow-up were included in this study']",[],"['ODI, LKA and VHL', 'clinical and demographical features, local kyphotic angles (LKA), vertebra height loss percentage (VHL), Oswestry Disability Index (ODI), Visual Analog Scale (VAS) and time to return to work', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0424641', 'cui_str': 'Decrease in height'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",4.0,0.0245825,"ODI, LKA and VHL were significantly lower in the surgery group (p<0.001, p<0.001 and p<0.001, respectively).","[{'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Karaali', 'Affiliation': 'Department of Orthopedics and Traumatology, Adana City Hospital, Adana-Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Ciloglu', 'Affiliation': 'Department of Orthopedics and Traumatology, Adana City Hospital, Adana-Turkey.'}, {'ForeName': 'Altuğ', 'Initials': 'A', 'LastName': 'Duramaz', 'Affiliation': 'Department of Orthopedics and Traumatology, Bakırköy Dr. Sadi Konuk Training and Research Hospital, İstanbul-Turkey.'}, {'ForeName': 'Aslihan', 'Initials': 'A', 'LastName': 'Kusvuran Ozkan', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Özülkü Medical Center, Adana-Turkey.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Ekiz', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, İstanbul Gedik University Faculty of Health Sciences, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2020.30524']
3009,32946133,Randomized preclinical study of machine perfusion in vascularized composite allografts.,"BACKGROUND


Attempts to improve limb preservation for transplantation using ex vivo perfusion have yielded promising results. However, metabolic acidosis, aberrant perfusate biochemistry and significant perfusion-induced oedema are reported universally. Optimizing perfusion protocols is therefore essential for maintaining tissue health.
METHODS


A randomized, two-stage open preclinical trial design was used to determine the optimal temperature and mean arterial pressure for machine perfusion. Conditions compared were: normothermic machine perfusion at 70 mmHg (NMP-70); subnormothermic perfusion (28°C) at 70 mmHg; subnormothermic (28°C) perfusion at 50 mmHg; and hypothermic perfusion (10°C) at 30 mmHg. Following this, a head-to-head experiment was undertaken comparing the optimal machine perfusion with static cold storage. Paired bilateral limbs (10 in total) were randomized to either 8 h of static cold storage, or 2 h of static cold storage and 6 h of optimal machine perfusion. Both groups of limbs were then reperfused on a circuit primed with matched blood from unrelated donors for 4 h without immunosuppression.
RESULTS


NMP-70 resulted in less tissue injury and stable perfusion biochemistry. Assessing reperfusion outcomes, static cold storage resulted in acidosis with increased lactate and a worsening electrolyte profile, necessitating bolus infusions of bicarbonate to prevent graft loss. Conversely, NMP-70 was associated with haemodynamic and biochemical stability. Histologically, on reperfusion with allogeneic whole blood, limbs subjected to static cold storage exhibited multifocal ischaemic injury and increased inflammation, which was absent with NMP-70. Static cold storage also resulted in significant oedema compared with NMP-70.
CONCLUSION


Normothermic perfusion resulted in superior graft preservation and less reperfusion injury compared with the current static cold storage protocol. Surgical relevance Vascularized composite allotransplantation (VCA) represents more than a surgical challenge. Injury to the limb during donor surgery, preservation and transplant surgery all contribute significantly to post-transplant morbidity and graft loss. In this study, the authors use a pig limb transplant model to demonstrate that normothermic machine perfusion of the VCA improves tissue integrity of the graft with less reperfusion injury in the immediate post-transplant period.",2020,"Histologically, on reperfusion with allogeneic whole blood, limbs subjected to static cold storage exhibited multifocal ischaemic injury and increased inflammation, which was absent with NMP-70.","['Paired bilateral limbs (10 in total', 'vascularized composite allografts']","['machine perfusion', 'Surgical relevance Vascularized composite allotransplantation (VCA', 'static cold storage, or 2\u2009h of static cold storage and 6\u2009h of optimal machine perfusion', 'VCA', 'normothermic machine perfusion at 70\u2009mmHg (NMP-70); subnormothermic perfusion', 'bicarbonate']","['tissue injury and stable perfusion biochemistry', 'tissue integrity', 'graft loss', 'superior graft preservation', 'optimal temperature and mean arterial pressure for machine perfusion', 'metabolic acidosis, aberrant perfusate biochemistry and significant perfusion-induced oedema']","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042382', 'cui_str': 'Vascularized'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042382', 'cui_str': 'Vascularized'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}]","[{'cui': 'C4552279', 'cui_str': 'Tissue injury'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",,0.0983095,"Histologically, on reperfusion with allogeneic whole blood, limbs subjected to static cold storage exhibited multifocal ischaemic injury and increased inflammation, which was absent with NMP-70.","[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Amin', 'Affiliation': 'Ex-Vivo Lab, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Stone', 'Affiliation': 'Ex-Vivo Lab, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'Ex-Vivo Lab, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Geraghty', 'Affiliation': 'Ex-Vivo Lab, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Joseph', 'Affiliation': 'Department of Pathology, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Montero-Fernandez', 'Affiliation': 'Ex-Vivo Lab, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Wong', 'Affiliation': 'Blond McIndoe Laboratories, Division of Cell Matrix Biology and Regenerative Medicine, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Fildes', 'Affiliation': 'Ex-Vivo Lab, Manchester Academic Health Science Centre, Manchester, UK.'}]",The British journal of surgery,['10.1002/bjs.11921']
3010,32946181,Using Lower Amplitudes to Maintain Effective High Dose Spinal Cord Stimulation Therapy (SCS Dosing Pilot Study).,"BACKGROUND


Spinal cord stimulation is an effective therapy for chronic back and/or leg pain. Amplitude dose-response studies are lacking; therefore, little guidance exists regarding the minimum amplitude requirements with specific high dose parameters. This study characterized the minimum amplitude level that maintained SCS therapy satisfaction and pain relief when stimulating at 1000 Hz and 90 μsec.
MATERIALS AND METHODS


Qualified patients had back and leg pain, an implanted neurostimulator programmed to 1000 Hz and 90 μsec, and were very or somewhat satisfied with the therapy, and an average overall VAS pain score ≤ 4 from a daily diary. Patients received four blinded amplitudes (titrated from 80%, 60%, 40%, and 20% of baseline perception threshold), approximately two weeks each, with 1000 Hz and 90 μsec and position-adaptive stimulation enabled. Patients' satisfaction and overall VAS pain scores were collected for each period. All patients continued through the study, even after reporting lack of therapy satisfaction or pain relief.
RESULTS


The minimum amplitude, which maintained therapy satisfaction, was 80% of perception threshold for two patients, 60% for one patient, and 20% for 21 patients. Additionally, six patients lost satisfaction changing from their baseline amplitude to 80% perception threshold. The minimum amplitude level, which maintained overall pain relief, was 80% perception threshold for three patients, 60% perception threshold for one patient, 40% perception threshold for two patients, and 20% perception threshold for 19 patients. Five patients required the setting they were programmed to during the baseline period.
CONCLUSION


The qualified study patients defined an implanted population reporting good pain relief and satisfaction using HD SCS therapy at baseline. The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude. Amplitudes below perception threshold could potentially maintain effective SCS therapy with HD stimulation in a subset of patients.",2020,"The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude.","['chronic back and/or leg pain', 'Qualified patients had back and leg pain, an implanted neurostimulator programmed to 1000 Hz and 90\u2009μsec, and were very or somewhat satisfied with the therapy, and an average overall VAS pain score\u2009≤\u20094 from a daily diary']",[],"['therapy satisfaction or pain relief', 'minimum amplitude level, which maintained overall pain relief', ""Patients' satisfaction and overall VAS pain scores"", 'pain relief', 'maintain therapy satisfaction and pain relief']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C2048402', 'cui_str': 'Implanted Nerve Stimulation Electrodes'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",[],"[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.052408,"The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude.","[{'ForeName': 'Amr O', 'Initials': 'AO', 'LastName': 'El-Naggar', 'Affiliation': 'Drez One, Somerset, KY, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Reis', 'Affiliation': 'Regional Brain and Spine, LLC, Cape Girardeau, MO, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hatheway', 'Affiliation': 'Northwest Pain Care, Spokane, WA, USA.'}, {'ForeName': 'Todd E', 'Initials': 'TE', 'LastName': 'Schmidt', 'Affiliation': 'Goodman Campbell Brain and Spine, Carmel, IN, USA.'}, {'ForeName': 'Tristan C', 'Initials': 'TC', 'LastName': 'Pico', 'Affiliation': 'AZ Pain Doctors, Chandler, AZ, USA.'}, {'ForeName': 'Mahendra R', 'Initials': 'MR', 'LastName': 'Sanapati', 'Affiliation': 'Global Scientific Innovations, Evensville, IN, USA.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Abd-Elsayed', 'Affiliation': 'Department of Anesthesiology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Amit S', 'Initials': 'AS', 'LastName': 'Patel', 'Affiliation': 'Georgia Pain and Wellness, Atlanta, GA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Calodney', 'Affiliation': 'Precision Spine Care, Tyler, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Johanek', 'Affiliation': 'Medtronic, Minneapolis, MN, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Medtronic, Minneapolis, MN, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'McCammon', 'Affiliation': 'Medtronic, Minneapolis, MN, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13258']
3011,32811627,Making lemonade from SARS coronavirus-2 lemons: Transitioning a smoking cessation trial to a virtual platform.,"Clinical trials represent an essential component of improving treatment for substance use disorders (SUD). The SARS coronavirus-2 pandemic disrupted our ongoing clinical trial of smoking cessation and forced us to rapidly implement changes to assure participants access to ongoing counseling and monitoring via telephone calls and/or video chat sessions. Our experiences suggest that this pandemic will lead to changes for both future clinical trial participants and project staff. While challenges remain, it will be important to assessing the impact of these changes with regard to participant experiences and treatment outcomes.",2020,The SARS coronavirus-2 pandemic disrupted our ongoing clinical trial of smoking cessation and forced us to rapidly implement changes to assure participants access to ongoing counseling and monitoring via telephone calls and/or video chat sessions.,[],[],[],[],[],[],,0.0225418,The SARS coronavirus-2 pandemic disrupted our ongoing clinical trial of smoking cessation and forced us to rapidly implement changes to assure participants access to ongoing counseling and monitoring via telephone calls and/or video chat sessions.,"[{'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Mahoney', 'Affiliation': 'Department of Internal Medicine, Roswell Park Cancer Institute, Buffalo, NY 14623, United States of America. Electronic address: martin.mahoney@roswellpark.org.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, United States of America. Electronic address: rlashare@pennmedicine.upenn.edu.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Schlienz', 'Affiliation': 'Department of Psychology, University at Buffalo, Buffalo, NY 14214, United States of America. Electronic address: schlienz@buffalo.edu.'}, {'ForeName': 'CeCe', 'Initials': 'C', 'LastName': 'Duerr', 'Affiliation': 'Department of Psychology, University at Buffalo, Buffalo, NY 14214, United States of America. Electronic address: cduerr@buffalo.edu.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Hawk', 'Affiliation': 'Department of Psychology, University at Buffalo, Buffalo, NY 14214, United States of America. Electronic address: lhawk@buffalo.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108100']
3012,32942245,Evaluation of the symptom-focused health assessment and empathy program for undergraduate nursing students: A randomized controlled trial.,"BACKGROUND


Health assessments are a vital competency required of nurses. The more traditional ways of teaching and learning this skill require practice and are often limited by time constraints. With the rise of technology-based platforms, students can supplement their learning health assessment skills through other means, such as videos, that not only teach the steps but also allow them to learn in context.
OBJECTIVES


This study describes how a symptom-focused health assessment and empathy (SHAE) program, which primarily involves the use of a case-based health assessment video, was implemented and evaluated.
DESIGN


The study involved a single-centre, single-blind, parallel randomized controlled trial.
SETTINGS


The study was conducted at a university in Singapore.
PARTICIPANTS


Year one undergraduate nursing students enrolled in the Comprehensive Health Assessment (CHA) module during semester two of the academic year 2018/2019 participated in the study.
METHODS


Participants were randomized into one of the two parallel groups: the experimental group or the waitlisted control (WL) group. The experimental group received the SHAE program in addition to conventional learning methods (e-lectures, lab demonstration, and pair practice). The WL group received only the conventional learning methods. Pre- and post-test measures of the study variables such as knowledge, health assessment skills, confidence, empathy, and intention to learn were conducted. The WL group was given access to the SHAE program after the post-test. Analyses of covariance (ANCOVA) were used to compare the means of the study variables between the intervention and WL groups.
RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004). No significant differences in intention to learn and empathy between the two groups were found.
CONCLUSION


The use of a case-based video has the potential to be a valuable method of teaching health assessments in context to nursing students. The SHAE program has shown beneficial effects on students' knowledge, health assessment skills, and confidence. However, there was no effect on students' intentions to learn and their empathy. Further refinements of the program will need to focus on improving these domains.",2020,"RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004).","['Participants', 'university in Singapore', 'Year one undergraduate nursing students enrolled in the Comprehensive Health Assessment (CHA) module during semester two of the academic year 2018/2019 participated in the study', 'undergraduate nursing students']","['conventional learning methods', 'SHAE program', 'symptom-focused health assessment and empathy program', 'waitlisted control (WL']","['knowledge', 'knowledge, health assessment skills, confidence, empathy, and intention to learn', 'health assessment skills', 'intention to learn and empathy', ""students' intentions to learn and their empathy""]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0319629,"RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004).","[{'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurch@nus.edu.sg.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Ignacio', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurimjj@nus.edu.sg.'}, {'ForeName': 'Piyanee', 'Initials': 'P', 'LastName': 'Yobas', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurpk@nus.edu.sg.'}]",Nurse education today,['10.1016/j.nedt.2020.104566']
3013,32942255,The Novel Single-Stroke Kayak Test: Can It Discriminate Between 200-m and Longer-Distance (500- and 1000-m) Specialists in Canoe Sprint?,"PURPOSE


To test whether the force-velocity (F-V) relationship obtained during a specific single-stroke kayak test (SSKT) and during nonspecific traditional resistance-training exercises (bench press and prone bench pull) could discriminate between 200-m specialists and longer-distance (500- and 1000-m) specialists in canoe sprint.
METHODS


A total of 21 experienced male kayakers (seven 200-m specialists and 14 longer-distance specialists) participated in this study. After a familiarization session, kayakers came to the laboratory on 2 occasions separated by 48 to 96 hours. In a randomized order, kayakers performed the SSKT in one session and the bench press and bench pull tests in another session. Force and velocity outputs were recorded against 5 loads in each exercise to determine the F-V relationship and related parameters (maximum force, maximum velocity, F-V slope, and maximum power).
RESULTS


The individual F-V relationships were highly linear for the SSKT (r = .990 [.908, .998]), bench press (r = .993 [.974, .999]), and prone bench pull (r = .998 [.992, 1.000]). The F-V relationship parameters (maximum force, maximum velocity, and maximum power) were significantly higher for 200-m specialists compared with longer-distance specialists (all Ps ≤ .047) with large effect sizes (≥0.94) revealing important practical differences. However, no significant differences were observed between 200-m specialists and longer-distance specialists in the F-V slope (P ≥ .477).
CONCLUSIONS


The F-V relationship assessed during both specific (SSKT) and nonspecific upper-body tasks (bench press and bench pull) may distinguish between kayakers specialized in different distances.",2020,"However, no significant differences were observed between 200-m specialists and longer-distance specialists in the F-V slope (P ≥ .477).
",['A total of 21 experienced male kayakers (seven 200-m specialists and 14 longer-distance specialists) participated in this study'],['force-velocity (F-V) relationship obtained during a specific single-stroke kayak test (SSKT) and during nonspecific traditional resistance-training exercises'],"['F-V relationship parameters (maximum force, maximum velocity, and maximum power', 'Force and velocity outputs']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0336847', 'cui_str': 'Kayak'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",21.0,0.078658,"However, no significant differences were observed between 200-m specialists and longer-distance specialists in the F-V slope (P ≥ .477).
","[{'ForeName': 'Milos R', 'Initials': 'MR', 'LastName': 'Petrovic', 'Affiliation': ''}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': ''}, {'ForeName': 'Danica N', 'Initials': 'DN', 'LastName': 'Janicijevic', 'Affiliation': ''}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': ''}, {'ForeName': 'Olivera M', 'Initials': 'OM', 'LastName': 'Knezevic', 'Affiliation': ''}, {'ForeName': 'Dragan M', 'Initials': 'DM', 'LastName': 'Mirkov', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0925']
3014,32942294,The effects of pre-intervention mindset induction on a brief intervention to increase risk perception and reduce alcohol use among university students: A pilot randomized controlled trial.,"OBJECTIVE


Brief interventions based on personalized feedback have shown promising results in reducing risky alcohol use among university students. We investigated the effects of activating deliberative (predecisional) or implemental (postdecisional) mindsets on the effectiveness of a standardized brief intervention, the ASSIST-linked Brief Intervention. This intervention comprises a personalized feedback and a decisional balance exercise. We hypothesized that participants in a deliberative mindset should show better outcomes related to risk perception and behavior than participants in an implemental mindset.
METHODS


A sample of 257 students provided baseline measures on risk perception, readiness to change, and alcohol use. Of those, 64 students with risky alcohol use were randomly allocated to one of two mindset induction conditions-deliberative or implemental mindset. Thereafter, they received the ASSIST-linked Brief Intervention and completed self-report questionnaires on changes in risk perception, alcohol use, and readiness to change at post-intervention and four-week follow-up.
RESULTS


In contrast to our hypotheses, the four-weeks follow-up revealed that participants in the implemental mindset consumed significantly less alcohol than participants in a deliberative mindset did. The former decreased and the latter increased their alcohol intake; resistance to the brief intervention was stronger in the latter condition. However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
CONCLUSIONS


These findings suggest that mindset induction is a powerful moderator of the effects of the ASSIST-linked Brief Intervention. We argue that systematic research on mindset effects on brief intervention techniques aimed to reduce risky alcohol use is highly needed in order to identify the processes involved with commitment and resistance being the main candidates.",2020,"However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
","['64 students with risky alcohol use', '257 students', 'university students']","['activating deliberative (predecisional) or implemental (postdecisional) mindsets', 'mindset induction conditions-deliberative or implemental mindset']","['risk perceptions', 'alcohol intake; resistance', 'risk perception and behavior', 'risk perception, readiness to change, and alcohol use', 'risk perception']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",257.0,0.0171764,"However, neither deliberative nor implemental mindset participants showed any changes in risk perceptions or in their readiness to change alcohol consumption.
","[{'ForeName': 'Natascha', 'Initials': 'N', 'LastName': 'Büchele', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Keller', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Anja C', 'Initials': 'AC', 'LastName': 'Zeller', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Schrietter', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Treiber', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gollwitzer', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Odenwald', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}]",PloS one,['10.1371/journal.pone.0238833']
3015,32942327,Effects of Sucrose and Nonnutritive Sucking on Pain Behavior in Neonates and Infants undergoing Wound Dressing after Surgery: A Randomized Controlled Trial.,"INTRODUCTION


Wound dressing, a procedure that pediatric patients are commonly exposed to postoperatively, can cause strong physiological and pain behavioral responses despite being brief. This study evaluated the effects of using 24% sucrose plus a pacifier versus a pacifier alone to reduce the pain response from dressing wounds in neonates and infants.
MATERIALS AND METHODS


Thirty-two neonates and infants who underwent surgery and required postoperative wound dressing were randomized to a pacifier group ( n  = 16) and a 24% sucrose plus pacifier group (""sucrose group"";  n  = 16). Demographic data, crying time, and pain behaviors were recorded using a video recorder. The pain behaviors were assessed independently using the neonatal infant pain scale (NIPS) by three assessors, who were expert in pediatric pain assessment and blinded to the subject allocations.
RESULTS


Participants in the sucrose group were older than those in the pacifier group (6.19 ± 2.95 vs. 3.88 ± 3.2 months). While there were no differences in the NIPS scores of the two groups at 30, 120, and 240 seconds, the incidence of moderate-to-severe pain was lower in the sucrose group than the pacifier group at 120 seconds (37.5 vs. 50%). The crying time was lower in the sucrose group, but without statistical significance.
CONCLUSION


The 24% sucrose plus pacifier was not superior to the pacifier alone in decreasing pain behavioral responses. Dressing wound pain produced a high-intensity pain behavioral response. A pain management strategy should be developed to lessen the postoperative procedural pain in pediatric patients.",2020,"While there were no differences in the NIPS scores of the two groups at 30, 120, and 240 seconds, the incidence of moderate-to-severe pain was lower in the sucrose group than the pacifier group at 120 seconds (37.5 vs. 50%).","['Neonates and Infants undergoing Wound Dressing after Surgery', 'Thirty-two neonates and infants who underwent surgery and required postoperative wound dressing', 'pediatric patients', 'neonates and infants']","['pacifier group ( n \u2009=\u200916) and a 24% sucrose plus pacifier group (""sucrose group"";  n \u2009=\u200916', '24% sucrose plus a pacifier versus a pacifier alone', 'Sucrose and Nonnutritive Sucking', 'sucrose plus pacifier']","['Demographic data, crying time, and pain behaviors', 'NIPS scores', 'Pain Behavior', 'pain behaviors', 'incidence of moderate-to-severe pain', 'pain response', 'neonatal infant pain scale (NIPS', 'crying time', 'pain behavioral responses']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030172', 'cui_str': 'Infant oral pacifier'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",32.0,0.0807969,"While there were no differences in the NIPS scores of the two groups at 30, 120, and 240 seconds, the incidence of moderate-to-severe pain was lower in the sucrose group than the pacifier group at 120 seconds (37.5 vs. 50%).","[{'ForeName': 'Sahatsa', 'Initials': 'S', 'LastName': 'Mandee', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Mahidol University, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kusuma', 'Initials': 'K', 'LastName': 'Buachai', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Mahidol University, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Naiyana', 'Initials': 'N', 'LastName': 'Aroonpruksakul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Mahidol University, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Niramol', 'Initials': 'N', 'LastName': 'Tantemsapya', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Mahidol University, Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Tarinee', 'Initials': 'T', 'LastName': 'Buasuk', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Mahidol University, Siriraj Hospital, Bangkok, Thailand.'}]",European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie,['10.1055/s-0040-1716883']
3016,32942346,Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications.,"Introduction


Bipolar disorder is a complex mood disorder characterized by a chronic and subtle course of fluctuating manic/hypomanic and depressive symptoms. Cariprazine, a dopamine D₃-preferring D₃/D₂ receptor partial agonist with serotonin 5-HT1A receptor partial agonist and serotonin 5-HT2A antagonist properties, is approved to treat manic and depressive episodes of bipolar disorder. Post hoc analyses evaluated efficacy across symptoms in bipolar depression.
Methods


Pooled data were analyzed from 3 phase 2 or 3, randomized, double-blind, placebo-controlled studies of adults with bipolar disorder and a major depressive episode. Mean change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score and individual item scores were analyzed in individual dose groups (1.5 mg/d, 3 mg/d) and overall cariprazine (1.5-3 mg/d). Pooled safety was evaluated via adverse events.
Results


A significantly greater difference in mean change from baseline in MADRS total score was seen for each cariprazine dose group versus placebo (least squares mean difference vs placebo: 1.5-3 mg/d = -2.6, 1.5 mg/d = -2.8, 3 mg/d = -2.4) (P < .001 all). Significant differences versus placebo were seen on all individual MADRS items except inner tension for the overall cariprazine group (P < .05). Cariprazine was generally well tolerated.
Conclusions


Cariprazine demonstrated broad efficacy across symptoms of depression in bipolar disorder. In previous post hoc analyses, cariprazine also demonstrated broad efficacy across manic symptoms, suggesting that it is effective across the wide range of symptoms on the bipolar spectrum. A 1.5-mg/d starting dose and slow titration resulted in lower rates of some adverse events in the bipolar depression studies versus the mania studies.
Trial Registration


ClinicalTrials.gov identifiers: NCT01396447, NCT02670538, NCT02670551.",2020,"A significantly greater difference in mean change from baseline in MADRS total score was seen for each cariprazine dose group versus placebo (least squares mean difference vs placebo: 1.5-3 mg/d = -2.6, 1.5 mg/d = -2.8, 3 mg/d = -2.4) (P < .001 all).",['adults with bipolar disorder and a major depressive episode'],"['cariprazine', 'placebo', 'Cariprazine']","['MADRS total score', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score and individual item scores', 'tolerated', 'Depressive Symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]","[{'cui': 'C2936870', 'cui_str': 'cariprazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.368025,"A significantly greater difference in mean change from baseline in MADRS total score was seen for each cariprazine dose group versus placebo (least squares mean difference vs placebo: 1.5-3 mg/d = -2.6, 1.5 mg/d = -2.8, 3 mg/d = -2.4) (P < .001 all).","[{'ForeName': 'Lakshmi N', 'Initials': 'LN', 'LastName': 'Yatham', 'Affiliation': 'University Hospital-Detwiller Pavilion 2883, 2255 Wesbrook Mall, Vancouver, BC, V6T 2A1, Canada. l.yatham@ubc.ca.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Department of Psychiatry and Psychology, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry, Texas Tech University School of Medicine-Permian Basin, Midland, Texas, USA.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Medical Affairs, AbbVie, Madison, New Jersey, USA.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Earley', 'Affiliation': 'Clinical Development, AbbVie, Madison, New Jersey, USA.'}]",The primary care companion for CNS disorders,['10.4088/PCC.20m02611']
3017,32942424,"Pore-by-pore modeling, analysis, and prediction of two-phase flow in mixed-wet rocks.","A pore-network model is an upscaled representation of the pore space and fluid displacement, which is used to simulate two-phase flow through porous media. We use the results of pore-scale imaging experiments to calibrate and validate our simulations, and specifically to find the pore-scale distribution of wettability. We employ energy balance to estimate an average, thermodynamic, contact angle in the model, which is used as the initial estimate of contact angle. We then adjust the contact angle of each pore to match the observed fluid configurations in the experiment as a nonlinear inverse problem. The proposed algorithm is implemented on two sets of steady state micro-computed-tomography experiments for water-wet and mixed-wet Bentheimer sandstone. As a result of the optimization, the pore-by-pore error between the model and experiment is decreased to less than that observed between repeat experiments on the same rock sample. After calibration and matching, the model predictions for capillary pressure and relative permeability are in good agreement with the experiments. The proposed algorithm leads to a distribution of contact angle around the thermodynamic contact angle. We show that the contact angle is spatially correlated over around 4 pore lengths, while larger pores tend to be more oil-wet. Using randomly assigned distributions of contact angle in the model results in poor predictions of relative permeability and capillary pressure, particularly for the mixed-wet case.",2020,"Using randomly assigned distributions of contact angle in the model results in poor predictions of relative permeability and capillary pressure, particularly for the mixed-wet case.",[],[],[],[],[],[],,0.0165262,"Using randomly assigned distributions of contact angle in the model results in poor predictions of relative permeability and capillary pressure, particularly for the mixed-wet case.","[{'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Foroughi', 'Affiliation': 'Department of Earth Science and Engineering, Imperial College London, London, SW7 2AZ, United Kingdom.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Bijeljic', 'Affiliation': 'Department of Earth Science and Engineering, Imperial College London, London, SW7 2AZ, United Kingdom.'}, {'ForeName': 'Qingyang', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Earth Science and Engineering, Imperial College London, London, SW7 2AZ, United Kingdom.'}, {'ForeName': 'Ali Q', 'Initials': 'AQ', 'LastName': 'Raeini', 'Affiliation': 'Department of Earth Science and Engineering, Imperial College London, London, SW7 2AZ, United Kingdom.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Blunt', 'Affiliation': 'Department of Earth Science and Engineering, Imperial College London, London, SW7 2AZ, United Kingdom.'}]",Physical review. E,['10.1103/PhysRevE.102.023302']
3018,32942555,"Intradialytic Cardiovascular Exercise Training Alters Redox Status, Reduces Inflammation and Improves Physical Performance in Patients with Chronic Kidney Disease.","Redox status (RS) perturbations and inflammation are fundamental features of chronic kidney disease (CKD) that are substantially exacerbated in end-stage renal disease (ESRD). This study aimed at investigating the efficacy of a 6-month intradialytic exercise training program on RS, inflammation and physical performance in patients with ESRD. Twenty hemodialysis (HD) patients (17 males, three females) were randomly assigned to either an intradialytic training (bedside cycling) group (TR;  n  = 10) or a control group (CON;  n  = 10) for 6 months. Anthropometrics [body mass and height, body mass index (BMI), body composition], physical performance (VO 2peak ), functional capacity [North Staffordshire Royal Infirmary (NSRI) walk test, sit-to-stand test (STS-60)], quality of life (short form-36 (SF-36) as well as RS [thiobarbituric acid reactive substances (TBARS), protein carbonyls (PC), reduced (GSH) and oxidized (GSSG) glutathione, GSH/GSSG, total antioxidant capacity (TAC), catalase activity (CAT)] and high-sensitivity C-reactive protein (hs-CRP) were assessed at baseline and after the 6-month intervention. Peak oxygen consumption (VO 2peak ) increased by 15% only in TR ( p  < 0.01). Performance in NSRI, STS-60 and SF-36 improved by 4-13% only in TR ( p  < 0.01). Exercise training reduced TBARS (by 28%), PC (by 31%) and hs-CRP (by 15%), and elevated GSH (by 52%), GSH/GSSG (by 51%), TAC (by 59%) and CAT (by 15%) ( p  < 0.01). These findings suggest that engagement in chronic intradialytic cardiovascular exercise alters RS, reduces inflammation and improves performance in patients with ESRD.",2020,"Performance in NSRI, STS-60 and SF-36 improved by 4-13% only in TR ( p  < 0.01).","['Twenty hemodialysis (HD) patients (17 males, three females', 'patients with ESRD', 'Patients with Chronic Kidney Disease']","['intradialytic training (bedside cycling) group (TR;  n  = 10) or a control group (CON', 'Intradialytic Cardiovascular Exercise Training', 'intradialytic exercise training program']","['Physical Performance', 'TBARS', 'GSH/GSSG', 'elevated GSH', 'TAC', 'Anthropometrics [body mass and height, body mass index (BMI), body composition], physical performance (VO 2peak ), functional capacity [North Staffordshire Royal Infirmary (NSRI) walk test, sit-to-stand test (STS-60)], quality of life (short form-36 (SF-36) as well as RS [thiobarbituric acid reactive substances (TBARS), protein carbonyls (PC), reduced (GSH) and oxidized (GSSG) glutathione, GSH/GSSG, total antioxidant capacity (TAC), catalase activity (CAT)] and high-sensitivity C-reactive protein (hs-CRP', 'Performance in NSRI, STS-60 and SF-36', 'RS, inflammation and physical performance', 'hs-CRP', 'PC', 'Peak oxygen consumption (VO 2peak ']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0454875', 'cui_str': 'Staffordshire'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",,0.0179865,"Performance in NSRI, STS-60 and SF-36 improved by 4-13% only in TR ( p  < 0.01).","[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Sovatzidis', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Chatzinikolaou', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Fatouros', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, 42100 Trikala, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Panagoutsos', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Draganidis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, 42100 Trikala, Greece.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Nikolaidou', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery & Burns ICU, General Hospital of Thessaloniki ""G. Papanikolaou"", 57010 Thessaloniki, Greece.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Avloniti', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Michailidis', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Mantzouridis', 'Affiliation': 'School of Physical Education and Sport Sciences, Democritus University of Thrace, 69100 Komotini, Greece.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Batrakoulis', 'Affiliation': 'School of Physical Education and Sport Sciences, University of Thessaly, Karies, 42100 Trikala, Greece.'}, {'ForeName': 'Ploumis', 'Initials': 'P', 'LastName': 'Pasadakis', 'Affiliation': 'Department of Nephrology, Faculty of Medicine, University Hospital of Alexandroupolis, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Vargemezis', 'Affiliation': ''}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9090868']
3019,32942627,Evaluation of Food-Intake Behavior in a Healthy Population: Personalized vs. One-Size-Fits-All.,"In public health initiatives, generic nutrition advice (GNA) from national guidelines has a limited effect on food-intake improvement. Personalized nutrition advice (PNA) may enable dietary behavior change. A monocentric, randomized, parallel, controlled clinical trial was performed in males ( n  = 55) and females ( n  = 100) aged 25 to 70 years. Participants were allocated to control, GNA or PNA groups. The PNA group consisted of automatically generated dietary advice based on personal metabolic health parameters, dietary intake, anthropometric and hemodynamic measures, gender and age. Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  = 0.0003), sugar-sweetened beverages ( p  = 0.005), added salt ( p  = 0.003) and less unhealthy choices ( p  = 0.002), whereas no improvements were observed in the control and GNA group. PNA participants were encouraged to set a goal for one or multiple food categories. Goal-setting led to greater improvement of food categories within the PNA group including; unsalted nuts ( p  < 0.0001), fruits ( p  = 0.0001), whole grains ( p  = 0.005), fish ( p  = 0.0001), dairy ( p  = 0.007), vegetables ( p  = 0.01) and unhealthy choices ( p  = 0.02). In a healthy population, participants receiving PNA changed their food-intake behavior more favorably than participants receiving GNA or no advice. When personal goals were set, nutritional behavior was more prone to change.",2020,"Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  =","['a Healthy Population', 'males ( n  = 55) and females ( n  = 100) aged 25 to 70 years']","['PNA', 'control, GNA or PNA', 'Personalized nutrition advice (PNA', 'GNA']","['sugar-sweetened beverages', 'nutritional intake status']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",100.0,0.0403269,"Participants who received PNA ( n  = 51) improved their nutritional intake status for fruits  P  ( p  < 0.0001), whole grains ( p  = 0.008), unsalted nuts ( p  < 0.0001), fish ( p  =","[{'ForeName': 'Femke P M', 'Initials': 'FPM', 'LastName': 'Hoevenaars', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Charlotte M M', 'Initials': 'CMM', 'LastName': 'Berendsen', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Wilrike J', 'Initials': 'WJ', 'LastName': 'Pasman', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'van den Broek', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Barrat', 'Affiliation': 'Laboratoire Lescuyer, Department of Research, 15 rue le Corbusier, CEDEX, F-17442 Aytré, France.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'de Hoogh', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO, Netherlands Organization for Applied Scientific Research, Research Group Microbiology & Systems Biology, P.O. Box 360, 3700 AJ Zeist, The Netherlands.'}]",Nutrients,['10.3390/nu12092819']
3020,32942663,Assessment of Active Video Games' Energy Expenditure in Children with Overweight and Obesity and Differences by Gender.,"(1) Background: Childhood obesity has become a main global health problem and active video games (AVG) could be used to increase energy expenditure. The aim of this study was to investigate the energy expenditure during an AVG intervention combined with exercise, differentiating by gender. (2) Methods: A total of 45 children with overweight or obesity (19 girls) performed an AVG intervention combined with exercise. The AVG used were the Xbox Kinect, Nintendo Wii, dance mats, BKOOL cycling simulator, and Nintendo Switch. The energy expenditure was estimated from the heart rate recorded during the sessions and the data from the individual maximal tests. (3) Results: The mean energy expenditure was 315.1 kilocalories in a one-hour session. Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii. Significant differences between boys and girls were found, but were partially due to the difference in weight, VO 2max , and fat-free mass. (4) Conclusions: The energy expenditure with AVG combined with multi-component exercise was 5.68 kcal/min in boys and 4.66 kcal/min in girls with overweight and obesity. AVG could be an effective strategy to increase energy expenditure in children and adolescents with overweight and obesity.",2020,"Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii.","['Children with Overweight and Obesity and Differences by Gender', 'girls with overweight and obesity', 'children and adolescents with overweight and obesity', '45 children with overweight or obesity (19 girls']","['AVG combined with multi-component exercise', 'AVG intervention combined with exercise', 'AVG']","['mean energy expenditure', 'weight, VO 2max , and fat-free mass', 'energy expenditure', 'heart rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",45.0,0.0423385,"Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Comeras-Chueca', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Villalba-Heredia', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Pérez-Llera', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lozano-Berges', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Marín-Puyalto', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Vicente-Rodríguez', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Matute-Llorente', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Casajús', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'González-Agüero', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186714']
3021,32942730,Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt.,"Wearable technologies provide many possibilities for applications in medicine, and especially in physiotherapy, where tracking and evaluation of body motion are of utmost importance. Despite the existence of multiple smart garments produced for applications in physiotherapy, there is limited information available on the actual impact of these technologies on the clinical outcomes. The objective of this paper is to evaluate the impact of the Double Aid (DAid) smart shirt, a purely textile-based system, on the training process of patients with subacromial pain syndrome. A randomized controlled trial was performed where patients with subacromial pain syndrome had to perform the assigned training exercises while employing the DAid smart shirt system. The core point of each exercise was to perform a movement while holding the shoulders stationary. The smart shirt was designed to sense even slight shoulder motion thus providing the patient with feedback on the accuracy of the motion, and allowing the patient to adjust the movement. The appropriate muscles should be strengthened through an increased effort to control the shoulder motion. The recovery of patients using the feedback system at the end of the treatment was compared to that of a reference group through standardized tests-the Disabilities of the Arm, Shoulder, and Hand score (DASH score), Closed Kinetic Chain Upper Extremity Stability test (CKCUES test), and internal/external rotation ratio. The test group that used the DAid system demonstrated significantly better results of the performed tests for all applied outcome measures compared to the reference group ( p  < 0.001). An overall positive impact on the patient recovery was observed from the DAid smart shirt system when applied for rehabilitation training of patients with subacromial pain syndrome.",2020,An overall positive impact on the patient recovery was observed from the DAid smart shirt system when applied for rehabilitation training of patients with subacromial pain syndrome.,"['Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt', 'patients with subacromial pain syndrome']",['training exercises while employing the DAid smart shirt system'],"['Hand score (DASH score), Closed Kinetic Chain Upper Extremity Stability test (CKCUES test), and internal/external rotation ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0453917', 'cui_str': 'Shirt'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442222', 'cui_str': 'Internal/external rotation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0332092,An overall positive impact on the patient recovery was observed from the DAid smart shirt system when applied for rehabilitation training of patients with subacromial pain syndrome.,"[{'ForeName': 'Guna', 'Initials': 'G', 'LastName': 'Semjonova', 'Affiliation': 'Department of Morphology, Faculty of Medicine, Riga Stradins University, LV-1010 Riga, Latvia.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Vetra', 'Affiliation': 'Department of Morphology, Faculty of Medicine, Riga Stradins University, LV-1010 Riga, Latvia.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Cauce', 'Affiliation': 'Statistics Unit, Faculty of Medicine, Riga Stradins University, LV-1046 Riga, Latvia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Oks', 'Affiliation': 'Institute of Design Technologies, Riga Technical University, LV-1048 Riga, Latvia.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Katashev', 'Affiliation': 'Institute of Biomedical Engineering and Nanotechnology, Riga Technical University, LV-1048 Riga, Latvia.'}, {'ForeName': 'Peteris', 'Initials': 'P', 'LastName': 'Eizentals', 'Affiliation': 'Institute of Biomedical Engineering and Nanotechnology, Riga Technical University, LV-1048 Riga, Latvia.'}]","Sensors (Basel, Switzerland)",['10.3390/s20185277']
3022,32942788,Relationship Between Epidural Steroid Dose and Suppression of Hypothalamus-Pituitary-Adrenal Axis.,"BACKGROUND


The suppression of hypothalamic-pituitary-adrenal (HPA) axis is a common complication associated with epidural steroid injections (ESIs). However, the effect of different doses is unknown.
OBJECTIVES


The primary objective was to compare the differences in the duration of HPA suppression following treatment with different doses of ESI; triamcinolone acetate (TA) 40 mg and TA 20 mg. The secondary objectives were to compare the extent of salivary cortisol (SC) reduction, the incidence of adrenal insufficiency (AI), and the differences in a numeric rating scale (NRS) depending on the varying levels of TA dose used for ESI.
STUDY DESIGN


A double-blind, parallel-group, randomized controlled trial.
SETTING


Pain clinics in a university hospital.
METHODS


The patients were treated with TA epidurally and divided into 2 groups (T20 and T40) depending on the dose of TA (20 mg and 40 mg). The SC concentration was measured before and after ESI to calculate the duration of HPA axis suppression, the extent of SC concentration reduction, and the SC recovery rate. Additionally, NRS and adrenocorticotropic hormone stimulation tests were used.
RESULTS


Thirty patients were analyzed. The T40 group showed longer HPA suppression (19.7 ± 3.1 days) compared with that of the T20 group (8.0 ± 2.4 days). The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015). However, there was no difference in the extent of reduction in SC concentration after ESI, the occurrence of AI, and pain reduction.
LIMITATIONS


There were selection bias and no placebo control.
CONCLUSIONS


Although the difference in pain relief according to the ESI dose is not significant, the HPA suppression is prolonged with a higher dose than a lower dose, and the recovery is slower. Therefore, the time interval between consecutive ESIs should be adjusted depending on the steroid dose to ameliorate the adverse effects of steroids.",2020,The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015).,"['Thirty patients were analyzed', 'Pain clinics in a university hospital']","['TA', 'ESI; triamcinolone acetate (TA']","['duration of HPA axis suppression', 'SC concentration after ESI, the occurrence of AI, and pain reduction', 'pain relief', 'SC concentration', 'longer HPA suppression', 'duration of HPA suppression', 'recovery rate', 'extent of salivary cortisol (SC) reduction, the incidence of adrenal insufficiency (AI), and the differences in a numeric rating scale (NRS) depending on the varying levels of TA dose used for ESI', 'HPA suppression']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3665848', 'cui_str': 'Hypothalamic pituitary adrenal axis suppression'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0271738', 'cui_str': 'Hypocortisolism secondary to another disorder'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",30.0,0.0473564,The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015).,"[{'ForeName': 'Sung-Eun', 'Initials': 'SE', 'LastName': 'Sim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Ju', 'Initials': 'HJ', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Kyungmoon', 'Initials': 'K', 'LastName': 'Roh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jaeho', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Sik', 'Initials': 'HS', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}]",Pain physician,[]
3023,32942789,"Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency with Steroid Injection in the Pain Management of Knee Osteoarthritis.","BACKGROUND


Knee osteoarthritis (KOA) is characterized by the clinical symptoms of chronic knee pain and knee dysfunction, leading to disability and influencing the quality of life in severe cases. Radiofrequency treatment is a new method to reduce KOA-related pain and partially improve knee joint dysfunction without adverse effect.
OBJECTIVE


The present study aimed to assess the treatment efficacy of radiofrequency thermocoagulation on the genicular nerve (RFTGN) and intraarticular pulsed radiofrequency (IAPRF) for KOA.
STUDY DESIGN


Retrospective comparative study design.
SETTING


This study took place at Shengjing Hospital of China Medical University.
METHOD


KOA patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of computed tomography (CT). The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, and 6-months after the treatment.
RESULTS


The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05). For the patients in the IAS group, the analgesic effect was in a rebound trend, which was the best at 1-week posttreatment, and was close to the preoperative level at 6-months posttreatment. The short-term (1 week or 1 month) analgesic effect of the RFTGN group was better than that of the IAPRF group, and was similar in the long-term (3 or 6 months). The long-term analgesic effect of RFTGN and IAPRF groups was better than that of IAS group. The results of the OKS score were similar to the NRS score. The RFTGN group showed markedly improved knee function in the long-term than the IAPRF and IAS groups. The short-term treatment satisfaction was similar in each group, and some differences were detected between the groups with respect to long-term treatment satisfaction.
LIMITATION


This study was a single-center retrospective study with a relatively small sample cohort and short follow-up periodCONCLUSION: Both RFTGN and IAPRF could alleviate the knee joint pain and improve the knee joint dysfunction; however, the treatment efficacy of RFTGN was better than that of IAPRF.",2020,The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05).,"['Knee osteoarthritis (KOA', 'KOA patients', 'Knee Osteoarthritis', 'place at Shengjing Hospital of China Medical University']","['radiofrequency thermocoagulation', 'Radiofrequency Thermocoagulation', 'IAS', 'intraarticular pulsed radiofrequency (IAPRF', 'RFTGN and IAPRF', 'computed tomography (CT', 'Steroid Injection', 'Radiofrequency treatment', 'RFTGN, IAPRF, and intraarticular steroid injection (IAS', 'IAPRF']","['numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE', 'analgesic effect', 'knee function', 'knee joint pain', 'short-term treatment satisfaction', 'knee joint dysfunction', 'postoperative NRS scores', 'OKS score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0908952', 'cui_str': 'iodoazidosalmeterol'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0214505,The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05).,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Guangxiao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Shimeng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}]",Pain physician,[]
3024,32942960,Verbal feedback enhances motor learning during post-stroke gait retraining.,"BACKGROUND


Fast treadmill walking combined with functional electrical stimulation to ankle muscles (FastFES) is a well-studied gait intervention that improves post-stroke walking function. Although individualized verbal feedback is commonly incorporated during clinical gait training, and a variable practice structure is posited to enhance learning, the influence of these two factors on motor learning during locomotor interventions such as FastFES is poorly understood.
OBJECTIVES


To determine if the addition of individualized verbal feedback or variable practice to a FastFES training session enhances motor learning of targeted gait patterns.
METHODS


Nine individuals with post-stroke hemiparesis completed a crossover study comprising exposure to 3 dose-matched types of gait training: (1) FastFES (FF), comprising five 6-minute bouts of training with intermittent FES, (2) FF with addition of individualized verbal instructions and faded feedback delivered by a physical therapist (FF+PT), (3) FF with variable gait speed and FES timing (FF+Var). Gait biomechanics data were collected before (Pre), immediately after (Post), and 24-h following (Retention) each training type. Within-session and retention change scores of 3 targeted gait variables were calculated to assess locomotor learning.
RESULTS


FF+PT resulted in larger improvements within-session and at retention in trailing limb angle, and a trend for larger improvements in paretic pushoff compared to FF. FF+Var failed to show greater learning of biomechanical variables compared to FF.
CONCLUSIONS


Addition of individualized verbal feedback (FF+PT) to a single session of gait training may enhance within- and across-session learning of targeted gait variables in people post-stroke, and merits more investigation.",2020,"RESULTS


FF+PT resulted in larger improvements within-session and at retention in trailing limb angle, and a trend for larger improvements in paretic pushoff compared to FF.",['Nine individuals with post-stroke\xa0hemiparesis completed a\xa0crossover study comprising'],"['Fast treadmill walking combined with functional electrical stimulation', 'FF+PT', 'Verbal feedback enhances motor learning during post-stroke gait retraining', 'FastFES training session', 'individualized verbal feedback (FF+PT', 'exposure to 3 dose-matched\xa0types of gait training: (1) FastFES (FF), comprising five 6-minute bouts of training with intermittent FES, (2) FF with addition of individualized verbal instructions and faded feedback delivered by a\xa0physical therapist (FF+PT), (3) FF with variable gait speed and FES timing (FF+Var']","['learning of biomechanical variables', 'Gait biomechanics data']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",9.0,0.122947,"RESULTS


FF+PT resulted in larger improvements within-session and at retention in trailing limb angle, and a trend for larger improvements in paretic pushoff compared to FF.","[{'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Rendos', 'Affiliation': 'Department of Rehabilitation Medicine, Division of Physical Therapy, Emory University School of Medicine , Atlanta, GA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zajac-Cox', 'Affiliation': 'Department of Rehabilitation Medicine, Division of Physical Therapy, Emory University School of Medicine , Atlanta, GA, USA.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Department of Rehabilitation Medicine, Division of Physical Therapy, Emory University School of Medicine , Atlanta, GA, USA.'}, {'ForeName': 'Sumire', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Neuroscience and Behavior Graduate Program, University of Massachusetts Amherst , Amherst, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Eicholtz', 'Affiliation': 'Department of Rehabilitation Medicine, Division of Physical Therapy, Emory University School of Medicine , Atlanta, GA, USA.'}, {'ForeName': 'Trisha M', 'Initials': 'TM', 'LastName': 'Kesar', 'Affiliation': 'Department of Rehabilitation Medicine, Division of Physical Therapy, Emory University School of Medicine , Atlanta, GA, USA.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1818480']
3025,32943015,Can cardiovascular risk management be improved by shared care with general practice to prevent cognitive decline following stroke/TIA? A feasibility randomised controlled trial (SERVED memory).,"BACKGROUND


Cognitive impairment and dementia following cerebrovascular disease are increasingly common in the UK. One potential strategy to prevent post-stroke cognitive decline is multimodal vascular risk factor management. However, its efficacy remains uncertain and its application in vulnerable patients with incident cerebrovascular disease and early cognitive impairment has not been assessed. The primary aim of this study was to assess the feasibility of recruitment and retention of patients with early cognitive impairment post-stroke or transient ischaemic attack (TIA) to a trial of enhanced vascular risk factor management combining primary and secondary care.
METHODS


In this single centre, open label trial adults with a recent stroke or TIA and mild cognitive impairment (MCI) were randomised 1:1 to a three-monthly multimodal vascular risk factor intervention jointly delivered by the trial team and General Practitioner (GP), or control (defined as usual care from the GP). Chosen risk factors were blood pressure (BP), total cholesterol, blood glucose (HbA1C) in those with diabetes, and heart rate and adequacy of anticoagulation in those with atrial fibrillation (AF). Similar patients with normal cognition were enrolled in an embedded observational cohort and also received usual care from the GP. Repeat cognitive screening was undertaken in all participants after 12 months.
RESULTS


Seventy three participants were recruited to the randomised trial and 94 to the observational cohort (21.8% of those screened). From the randomised trial 35/73 (47.9%) dropped out before final follow-up. In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up. The observational cohort demonstrated greater decline in cognitive test scores at 12 months, with no difference between the randomised groups.
CONCLUSIONS


Recruitment to such a study was feasible, but retention of participants was difficult and generally poor rates of risk factor control suggested insufficient application of the intervention. Consequently, successful scaling up of the trial would require protocol changes with less reliance on primary care services. Any future trial should include participants with normal cognition post-stroke as they may be at greatest risk of cognitive decline.
TRIAL REGISTRATION


ISRCTN, ISRCTN42688361 . Registered 16 April 2015.",2020,In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up.,"['Seventy', 'vulnerable patients with incident cerebrovascular disease and early cognitive impairment', 'three participants were recruited to the randomised trial and 94 to the observational cohort (21.8% of those screened', 'patients with early cognitive impairment post-stroke or transient ischaemic attack (TIA', 'Similar patients with normal cognition', 'open label trial adults with a recent stroke or TIA and mild cognitive impairment (MCI', 'participants with normal cognition post-stroke']","['multimodal vascular risk factor intervention jointly delivered by the trial team and General Practitioner (GP), or control (defined as usual care from the GP', 'usual care from the GP']","['heart rate and adequacy of anticoagulation', 'cognitive test scores', 'rates of risk factor control', 'Repeat cognitive screening', 'blood pressure (BP), total cholesterol, blood glucose (HbA1C']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C2712133', 'cui_str': 'Normal cognition'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",73.0,0.232762,In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Bob Champion Research Building, James Watson Road, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Ageing Clinical & Experimental Research Team (ACER), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Yoon K', 'Initials': 'YK', 'LastName': 'Loke', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Ravenhill', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Bob Champion Research Building, James Watson Road, Norwich, UK. john.potter@uea.ac.uk.'}]",BMC geriatrics,['10.1186/s12877-020-01760-z']
3026,32943031,Improving treatment decision-making in bipolar II disorder: a phase II randomised controlled trial of an online patient decision-aid.,"BACKGROUND


Many patients with bipolar II disorder (BPII) prefer to be more informed and involved in their treatment decision-making than they currently are. Limited knowledge and involvement in one's treatment is also likely to compromise optimal BPII management. This Phase II RCT aimed to evaluate the acceptability, feasibility, and safety of a world-first patient decision-aid website (e-DA) to improve treatment decision-making regarding options for relapse prevention in BPII. The e-DA's potential efficacy in terms of improving quality of the decision-making process and quality of the decision made was also explored.
METHODS


The e-DA was based on International Patient Decision-Aid Standards and developed via an iterative co-design process. Adults with BPII diagnosis (n = 352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations. Participants were randomised (1:1) to receive standard information with/without the e-DA (Intervention versus Control). At baseline (T0), post-treatment decision (T1) and at 3 months' post-decision follow-up (T2), participants completed a series of validated and purpose-designed questionnaires. Self-report and analytics data assessed the acceptability (e.g., perceived ease-of-use, usefulness; completed by Intervention participants only), safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA (% accessed). For all participants, questionnaires assessed constructs related to quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes).
RESULTS


Intervention participants endorsed the e-DA as acceptable and feasible to use (82.1-94.6% item agreement); most self-reported using the e-DA either selectively (51.8%; relevant sections only) or thoroughly (34%). Exploratory analyses indicated the e-DA's potential efficacy to improve decision-making quality; most between-group standardised mean differences (SMD) were small-to-moderate. The largest potential effects were detected for objective treatment knowledge (- 0.69, 95% CIs - 1.04, - 0.33 at T1; and - 0.57, 95% CIs - 0.99,-0.14 at T2), decisional regret at T2 (0.42, 95% CIs 0.01, 0.84), preparation for decision-making at T1 (- 0.44, 95% CIs - 0.81, - 0.07), and the Decisional Conflict Scale Uncertainty subscale (0.42, 95% CIs 0.08, 0.08) and Total (0.36, 95% CIs 0.30, 0.69) scores, with all SMDs favouring the Intervention over the Control conditions. Regarding safety, e-DA use was not associated with worse bipolar symptoms or anxiety.
CONCLUSION


The e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients' decision-making about BPII treatment. Findings also support the future adoption of the e-DA into patient care for BPII to foster treatment decisions based on the best available evidence and patient preferences.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12617000840381 (prospectively registered 07/06/2017).",2020,"The e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients' decision-making about BPII treatment.","['bipolar II disorder', 'Adults with BPII diagnosis (n\u2009=\u2009352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations', 'patients with bipolar II disorder (BPII']",['standard information with/without the e-DA (Intervention versus Control'],"['objective treatment knowledge', 'Decisional Conflict Scale Uncertainty subscale', 'safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA', 'acceptability, feasibility, and safety', 'e-DA as acceptable and feasible to use', 'quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes', 'decisional regret']","[{'cui': 'C0236788', 'cui_str': 'Bipolar II disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0080101', 'cui_str': 'Regret'}]",352.0,0.0483739,"The e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients' decision-making about BPII treatment.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'The University of Sydney, The School of Psychology, Sydney, NSW, 2006, Australia. a.fisher@sydney.edu.au.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Keast', 'Affiliation': 'The University of Sydney, The School of Psychology, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Costa', 'Affiliation': 'The University of Sydney, The School of Psychology, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'The University of Sydney, The School of Psychology, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Manicavasagar', 'Affiliation': 'The Black Dog Institute, University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'The Black Dog Institute, University of New South Wales, Sydney, NSW, 2052, Australia.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Juraskova', 'Affiliation': 'The University of Sydney, The School of Psychology, Sydney, NSW, 2006, Australia.'}]",BMC psychiatry,['10.1186/s12888-020-02845-0']
3027,32943033,Five gene signatures were identified in the prediction of overall survival in resectable pancreatic cancer.,"BACKGROUND


Although genes have been previously detected in pancreatic cancer (PC), aberrant genes that play roles in resectable pancreatic cancer should be further assessed.
METHODS


Messenger RNA samples and clinicopathological data corrected with PC were downloaded from The Cancer Genome Atlas (TCGA). Resectable PC patients were randomly divided into a primary set and a validation set. Univariable Cox regression analysis, lasso-penalized Cox regression analysis, and multivariable Cox analysis were implemented to distinguish survival-related genes (SRGs). A risk score based on the SRGs was calculated by univariable Cox regression analysis. A genomic-clinical nomogram was established by integrating the risk score and clinicopathological data to predict overall survival (OS) in resectable PC.
RESULTS


Five survival-related genes (AADAC, DEF8, HIST1H1C, MET, and CHFR) were significantly correlated with OS in resectable PC. The resectable PC patients, based on risk score, were sorted into a high-risk group that showed considerably unfavorable OS (p < 0.001) than the low-risk group, in both the primary set and the validation set. The concordance index (C-index) was calculated to evaluate the predictive performance of the nomogram were respectively in the primary set [0.696 (0.608-0.784)] and the validation set [0.682 (0.606-0.758)]. Additionally, gene set enrichment Analysis discovered several meaningful enriched pathways.
CONCLUSION


Our study identified five prognostic gene biomarkers for OS prediction and which facilitate postoperative molecular target therapy for the resectable PC, especially the nomic-clinical nomogram which may be used as an effective model for the postoperative OS evaluation and also an optimal therapeutic tool for the resectable PC.",2020,"RESULTS


Five survival-related genes (AADAC, DEF8, HIST1H1C, MET, and CHFR) were significantly correlated with OS in resectable PC.",['Resectable PC patients'],[],"['unfavorable OS', 'concordance index (C-index', 'overall survival']","[{'cui': 'C0854778', 'cui_str': 'Pancreatic carcinoma resectable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0322967,"RESULTS


Five survival-related genes (AADAC, DEF8, HIST1H1C, MET, and CHFR) were significantly correlated with OS in resectable PC.","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Pancreatic Surgery, West China Hospital, Sichuan University, No. 37 Guoxue Alley, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Zuowei', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Pancreatic Surgery, West China Hospital, Sichuan University, No. 37 Guoxue Alley, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Bole', 'Initials': 'B', 'LastName': 'Tian', 'Affiliation': 'Department of Pancreatic Surgery, West China Hospital, Sichuan University, No. 37 Guoxue Alley, Chengdu, Sichuan Province, China. bole_tian@163.com.'}]",BMC surgery,['10.1186/s12893-020-00856-y']
3028,32943041,Cost-consequence analysis of extended loading dose of anti-VEGF treatment in diabetic macular edema patients.,"BACKGROUND


The DRCR.net Protocol T clinical trial assessed the comparative efficacy and safety of anti-VEGF treatments including aflibercept, ranibizumab and bevacizumab in diabetic macular edema (DME). Post -hoc analyses showed that after a 12-week induction period, there was still DME resolution in an increasing number of patients through week 24.
PURPOSE


To assess clinical and cost consequences of extending the anti-VEGF loading dose from 3 to 6 monthly injections in patients with persistent DME in Spain.
METHODS


From a hospital pharmacy perspective, a cost-consequence analysis model was developed to estimate the incremental cost needed to obtain an additional response at month 6. To estimate drug treatment costs, ex-factory prices (€, 2019) were considered for aflibercept, ranibizumab and bevacizumab. Response/nonresponse rates at 3/6 months were obtained from the Protocol T 24-week post hoc analysis (n = 546). Persistent DME was present in 50.8 and 31.6% of the 190 aflibercept-treated patients at month 3 and month 6, respectively. Of the 176 ranibizumab- and 180 bevacizumab-treated patients, 53.2 and 72.9%, respectively, had persistent DME at month 3, and 41.5 and 65.6%, respectively, had persistent DME at month 6. Sensitivity analysis considered the split of bevacizumab vials.
RESULTS


Extending the loading dose in nonresponder patients would cost €214,862.57, €208,488.98 and €134,483.16 to obtain 37, 21 and 13 additional aflibercept, ranibizumab and bevacizumab responder patients, respectively. The total number of extended injections (months 3-6) used in patients with persistent DME at month 6 was 180, 219 and 354 for aflibercept, ranibizumab and bevacizumab, respectively.
CONCLUSIONS


To extend the anti-VEGF loading dose from 3 to 6 injections necessitates investing €5882.77 (8 injections), €10,091.03 (14 injections) and €10,198.59 (30 injections) per additional responder patient (3-month nonresponders and 6-month responders) to aflibercept, ranibizumab and bevacizumab, respectively. For the total of patients treated, on average €7927.02 (14 injections) per additional responder patient would be needed.",2020,"For the total of patients treated, on average €7927.02 (14 injections) per additional responder patient would be needed.","['diabetic macular edema patients', 'diabetic macular edema (DME', 'patients with persistent DME in Spain']","['bevacizumab', 'anti-VEGF treatment', 'aflibercept, ranibizumab and bevacizumab']","['Persistent DME', 'still DME resolution', 'total number of extended injections', 'Response/nonresponse rates']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.0798015,"For the total of patients treated, on average €7927.02 (14 injections) per additional responder patient would be needed.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Universidad de Castilla-La Mancha, Albacete, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Andrés-Nogales', 'Affiliation': 'Health Economics Department, Pharmacoeconomics & Outcomes Research Iberia, Paseo Joaquín Rodrigo 4 I, 28224, Pozuelo de Alarcón, Madrid, Spain. fdeandres@porib.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Oyagüez', 'Affiliation': 'Health Economics Department, Pharmacoeconomics & Outcomes Research Iberia, Paseo Joaquín Rodrigo 4 I, 28224, Pozuelo de Alarcón, Madrid, Spain.'}]",BMC ophthalmology,['10.1186/s12886-020-01637-0']
3029,32941345,Effects on Firefighters' Nocturnal Cardiac Autonomic Activity and Sleep Quality of On-Call Nights With and Without Firefighting Interventions.,"OBJECTIVE


To examine the effects on firefighters' nocturnal cardiac autonomic activity and sleep quality of one on-call night without intervention and one on-call night with intervention.
METHODS


Thirteen firefighters completed three experimental nights: a control night (CON), an on-call night without intervention (0-INTER), an on-call night with one simulated intervention (1-INTER). Sleep parameters were determined from nocturnal heart rate variability (HRV), objective and subjective sleep quality.
RESULTS


Derived parasympathetic HRV indices were higher in CON compared to 0-INTER and 1-INTER (p < 0.05). Subjective sleep quality and total sleep time were decreased in 1-INTER compared to CON and 0-INTER (p < 0.01).
DISCUSSION


These results revealed that for firefighters, being on-call during the night with and without interventions disturbs cardiac autonomic activity. Objective and subjective sleep quality were disrupted when on-call nights were interrupted by simulated firefighting interventions.",2020,"Subjective sleep quality and total sleep time were decreased in 1-INTER compared to CON and 0-INTER (p < 0.01).
",['Thirteen firefighters completed three experimental nights: a'],"['control night (CON), an on-call night without intervention (0-INTER), an on-call night with one simulated intervention (1-INTER', 'CON']","['parasympathetic HRV indices', ""Firefighters' Nocturnal Cardiac Autonomic Activity and Sleep Quality"", 'nocturnal heart rate variability (HRV), objective and subjective sleep quality', 'Subjective sleep quality and total sleep time', 'Objective and subjective sleep quality']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",13.0,0.0137091,"Subjective sleep quality and total sleep time were decreased in 1-INTER compared to CON and 0-INTER (p < 0.01).
","[{'ForeName': 'Philémon', 'Initials': 'P', 'LastName': 'Marcel-Millet', 'Affiliation': ""University of Bourgogne-Franche-Comte, Laboratory C3S (EA 4660), Department Sport and Performance, UPFR Sports, 31 Chemin de l'Epitaphe, 25000 Besançon, France (Marcel-Millet, Groslambert, Ravier).""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Groslambert', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Ravier', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002025']
3030,32941372,Consequences and Prognosis of Running-Related Knee Injuries Among Recreational Runners.,"OBJECTIVE


To investigate the consequences and prognostic factors of running-related knee injuries (RRKIs) among recreational runners.
DESIGN


Prospective cohort study.
SETTING


This study is part of a randomized-controlled trial (RCT) on running injury prevention among recreational runners. At baseline during registration for a running event (5-42 km), demographic and training variables were collected. Participants who reported a new RRKI during follow-up were sent a knee-specific questionnaire at 16 months (range 11.7-18.6) after baseline.
PARTICIPANTS


One hundred thirty-eight runners who reported a new RRKI during the RCT on injury prevention responded to the knee-specific questionnaire.
ASSESSMENT OF RISK FACTORS


To determine the association between potential prognostic factors and time to recovery of an RRKI, a Cox regression analysis was performed.
MAIN OUTCOME MEASURES


Time to recovery and prognostic factors of RRKIs.
RESULTS


At 16 months after registration, 71.0% of the participants reported full recovery, with a median time to recovery of 8.0 weeks. Most participants reported iliotibial band syndrome (23.2%) or osteoarthritis (OA)/degenerative meniscopathy (23.2%) as cause of their injury. Male sex was associated with a shorter time to recovery [hazard ratio (HR) 1.84; 95% confidence interval (CI), 1.14-2.97], while suffering knee OA was associated with a longer time to recovery (HR 0.17; 95% CI, 0.06-0.46).
CONCLUSIONS


Nonrecovered participants adjusted running speed more often and had knee imaging more often than recovered participants. At follow-up, one-third of the participants were not recovered. This emphasizes the need for injury prevention programs for runners. More knowledge on the role of running in knee OA seems important, given the high number of participants with knee OA symptoms.",2020,"Male sex was associated with a shorter time to recovery [hazard ratio (HR) 1.84; 95% confidence interval (CI), 1.14-2.97], while suffering knee OA was associated with a longer time to recovery (HR 0.17; 95% CI, 0.06-0.46).
","['One hundred thirty-eight runners who reported a new RRKI during the RCT on injury prevention responded to the knee-specific questionnaire', 'Recreational Runners', 'runners', 'recreational runners', 'participants with knee OA symptoms']",[],"['Time to recovery and prognostic factors of RRKIs', 'iliotibial band syndrome', 'full recovery', 'suffering knee OA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0263843', 'cui_str': 'Snapping hip'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]",138.0,0.117102,"Male sex was associated with a shorter time to recovery [hazard ratio (HR) 1.84; 95% confidence interval (CI), 1.14-2.97], while suffering knee OA was associated with a longer time to recovery (HR 0.17; 95% CI, 0.06-0.46).
","[{'ForeName': 'Kyra L A', 'Initials': 'KLA', 'LastName': 'Cloosterman', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Tryntsje', 'Initials': 'T', 'LastName': 'Fokkema', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Sita M A', 'Initials': 'SMA', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Marienke', 'Initials': 'M', 'LastName': 'van Middelkoop', 'Affiliation': 'Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000861']
3031,32941388,"Pentraxin-3, troponin T, N-terminal pro-B-type Natriuretic Peptide in septic patients.","OBJECTIVE


To investigate the behavior of pentraxin-3 (PTX3), troponin T (hsTnT), N-terminal pro-B type Natriuretic Peptide (NT-proBNP) in sepsis and their relationships with sepsis severity and oxygen transport/utilization impairment.
DESIGN


Retrospective analysis of PTX3, hsTnT, NT-proBNP levels at day 1, 2 and 7 after admission in the intensive care unit in a subset of the ALBIOS database SETTING:: 40 Italian intensive care units.
PATIENTS


958 septic patients enrolled in the randomized clinical trial comparing albumin replacement plus crystalloids and crystalloids alone INTERVENTIONS:: The patients were divided in sextiles of lactate (marker of severity), ScvO2 (marker of oxygen transport) and fluid balance (marker of therapeutic strategy).
MEASUREMENTS AND MAIN RESULTS


PTX3 and hsTnT were remarkably similar in the two treatment arms, while NT-proBNP was almost double in the albumin treatment group. However, as the distribution of all these biomarkers was similar between control and treatment arms, for sake of clarity, we analyzed the patients as a single cohort. PTX3 (71.8 [32.9-186.3] ng/ml), hsTnT (50.4 [21.6-133.6] ng/L) and NT-proBNP (4393 [1313-13837] ng/L)were abnormally elevated in 100%, 84.5%, 93.4% of the 953 patients and all decreased from day 1 to day 7. PTX3 monotonically increased with increasing lactate levels. The hsTnT levels were significantly higher when ScvO2 levels were abnormally low (< 70%), suggesting impaired oxygen transport compared to higher ScvO2 levels, suggesting impaired oxygen utilization. NT-proBNP was higher with higher lactate and fluid balance. At ScvO2 levels < 70%, the NT-proBNP was higher than at higher ScvO2 levels. However, even with higher ScvO2, the NT-proBNP was remarkably elevated, suggesting volume expansion. Increased level of NT-proBNP showed the strongest association with 90-day mortality.
CONCLUSIONS


The selected biomarkers seem related to different mechanisms during sepsis: PTX3 to sepsis severity, hsTnT to impaired oxygen transport, NT-proBNP to sepsis severity, oxygen transport and aggressive fluid strategy.",2020,"At ScvO2 levels < 70%, the NT-proBNP was higher than at higher ScvO2 levels.","[' 40 Italian intensive care units', 'septic patients', '958 septic patients enrolled']","['PTX3', 'pentraxin-3 (PTX3), troponin T (hsTnT), N-terminal pro-B type Natriuretic Peptide (NT-proBNP', 'albumin replacement plus crystalloids and crystalloids alone', 'sextiles of lactate (marker of severity), ScvO2 (marker of oxygen transport) and fluid balance (marker of therapeutic strategy']","['Increased level of NT-proBNP', 'NT-proBNP', 'lactate levels', 'ScvO2 levels']","[{'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}]",,0.119829,"At ScvO2 levels < 70%, the NT-proBNP was higher than at higher ScvO2 levels.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vassalli', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Masson', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Meessen', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Pasticci', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonifazi', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Vivona', 'Affiliation': 'Department of Pathophysiology and Trasplantation, University of Milan, Milan (MI) Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Caironi', 'Affiliation': 'SCDU Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Orbassano (TO), Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Busana', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Giosa', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Matteo Maria', 'Initials': 'MM', 'LastName': 'Macrì', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Romitti', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Novelli', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quintel', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Gattinoni', 'Affiliation': 'Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.'}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001543']
3032,32941395,Redefining Therapeutic Drug Monitoring of Tacrolimus in Patients Undergoing Liver Transplantation: A Target Trough Concentration of 4-7 ng/mL During the First Month After Liver Transplantation is Safe and Improves Graft and Renal Function.,"BACKGROUND


Currently, the recommended tacrolimus (TAC) trough level (Cmin) after liver transplantation (LT) is 6-10 ng/mL (when associated in triple immunosuppressive therapy). However, few studies have achieved the lower limit of this range, especially below 7 ng/mL. This study evaluated the efficacy of a target TAC Cmin of 4-7 ng/mL after LT.
METHODS


Of 1677 LTs performed between 2002 and 2017, 904 LT cases were analyzed. The cases were categorized into the following 3 groups and compared: low- (n = 247, 27.3%), intermediate- (n = 344, 37.9%), and high-exposure groups (n = 313, 34.5%) with TAC Cmin of 4-7 ng/mL, 7-10 ng/mL, and >10 ng/mL, respectively. In addition, propensity score matching was performed to reduce heterogeneity and population bias.
RESULTS


At months 1 and 3, when compared with the 2 other groups, the low-exposure group had similar grafts (P = 0.75) and patient (P = 0.77) survival, but lower alanine aminotransferase (P < 0.001), bilirubin (P < 0.001), international normalized ratio (P = 0.046), and creatinine (P < 0.001) levels. After propensity score matching, the bilirubin (P < 0.001) and creatinine (P = 0.001) levels in the low-exposure group still improved at months 3, but the graft (P = 0.86) and patient (P = 0.99) survival were still similar.
CONCLUSIONS


A TAC Cmin of 4-7 ng/mL seems safe and capable of improving graft and kidney function. This finding should be confirmed in a prospective randomized trial.",2020,"After propensity score matching, the bilirubin (P < 0.001) and creatinine (P = 0.001) levels in the low-exposure group still improved at months 3, but the graft (P = 0.86) and patient (P = 0.99) survival were still similar.
","['Of 1677 LTs performed between 2002 and 2017, 904 LT cases were analyzed', 'Patients Undergoing Liver Transplantation']",['Tacrolimus'],"['international normalized ratio', 'bilirubin', 'alanine aminotransferase', 'Safe and Improves Graft and Renal Function', 'safe and capable of improving graft and kidney function']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.136658,"After propensity score matching, the bilirubin (P < 0.001) and creatinine (P = 0.001) levels in the low-exposure group still improved at months 3, but the graft (P = 0.86) and patient (P = 0.99) survival were still similar.
","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lemaitre', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Tron', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Renard', 'Affiliation': 'CHU Rennes, Service de Chirurgie Hépatobiliaire et Digestive.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jézéquel', 'Affiliation': 'CHU Rennes, Service des Maladies du Foie.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Houssel-Debry', 'Affiliation': 'CHU Rennes, Service de Chirurgie Hépatobiliaire et Digestive.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bergeat', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Pastoret', 'Affiliation': ""CHU Rennes, Service d'Hématologie Cellulaire, Hémostase Bioclinique.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Collet', 'Affiliation': 'CHU Rennes, Service de Biochimie et Toxicologie.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Petitcollin', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Marie-Clémence', 'Initials': 'MC', 'LastName': 'Verdier', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Bardou-Jacquet', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Camus', 'Affiliation': 'INSERM, CIC 1414.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Boudjema', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bellissant', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rayar', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000779']
3033,32943047,Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation and chronic inflammation. Predicting exacerbations of COPD, which contribute to disease progression, is important to guide preventative treatment and improve outcomes. Blood eosinophils are a biomarker for patient responsiveness to inhaled corticosteroids (ICS); however, their effectiveness as a predictive biomarker for COPD exacerbations is unclear.
METHODS


This post hoc analysis pooled data from 11 Boehringer Ingelheim-sponsored Phase III and IV randomised COPD studies with similar methodologies. Exacerbation data were collected from these studies, excluding patients from the ICS withdrawal arm of the WISDOM® study. Patients were grouped according to their baseline blood eosinophil count, baseline ICS use and number of exacerbations in the year prior to each study.
RESULTS


Exacerbation rate data and baseline eosinophil count were available for 22,125 patients; 45.6% presented with a baseline blood eosinophil count of ≤ 150 cells/μL, 34.3% with 150-300 cells/μL and 20.1% with > 300 cells/μL. The lowest exacerbation rates were observed in patients with ≤ 150 cells/μL, with small increases in exacerbation rate observed with increasing eosinophil count. When stratified by exacerbation history, the annual rate of exacerbations for patients with 0 exacerbations in the previous year increased in line with increasing eosinophil counts (0.38 for ≤ 150 cells/μL, 0.39 for 150-300 cells/μL and 0.44 for > 300 cells/μL respectively). A similar trend was identified for patients with one exacerbation in the previous year, 0.62, 0.66 and 0.67 respectively. For patients with ≥ 2 exacerbations, exacerbation rates fluctuated between 1.02 (≤ 150 cells/μL) to 1.10 (150-300 cells/μL) and 1.07 (> 300 cells/μL). Higher exacerbation rates were noted in patients treated with ICS at baseline (range 0.75 to 0.82 with increasing eosinophil count) compared with patients not on ICS (range 0.45 to 0.49).
CONCLUSION


We found no clinically important relationship between baseline blood eosinophil count and exacerbation rate. Hence, the current analysis does not support the use of blood eosinophils to predict exacerbation risk; however, previous exacerbation history was found to be a more reliable predictor of future exacerbations.
TRIAL REGISTRATION


ClinicalTrials.gov Identifiers: NCT00168844 , NCT00168831 , NCT00387088 , NCT00782210 , NCT00782509 , NCT00793624 , NCT00796653 , NCT01431274 , NCT01431287 , NCT02296138 and NCT00975195 .",2020,"Higher exacerbation rates were noted in patients treated with ICS at baseline (range 0.75 to 0.82 with increasing eosinophil count) compared with patients not on ICS (range 0.45 to 0.49).
","['300 cells/μL', 'Chronic obstructive pulmonary disease (COPD']",[],"['baseline blood eosinophil count and exacerbation rate', 'baseline blood eosinophil count, baseline ICS use and number of exacerbations', 'eosinophil counts', 'lowest exacerbation rates', 'exacerbation rate', 'Exacerbation rate data and baseline eosinophil count', 'baseline blood eosinophil count', 'Higher exacerbation rates']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.345667,"Higher exacerbation rates were noted in patients treated with ICS at baseline (range 0.75 to 0.82 with increasing eosinophil count) compared with patients not on ICS (range 0.45 to 0.49).
","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK. DSingh@meu.org.uk.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'NIHR Leicester Biomedical Research Centre: Respiratory Theme, and Department of Respiratory Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Helgo', 'Initials': 'H', 'LastName': 'Magnussen', 'Affiliation': 'Pulmonary Research Institute at Lung Clinic Grosshansdorf, Grosshansdorf, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miravitlles', 'Affiliation': ""Pneumology Department, Hospital Universitari Vall d'Hebron/Vall d'Hebron Research Institute (VHIR), CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",Respiratory research,['10.1186/s12931-020-01482-1']
3034,32943059,Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study.,"BACKGROUND


Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions.
METHODS


The VICOCA study is a prospective, single-centre, randomised trial conducted from March 2014 to May 2016; 662 individuals were invited and 349 were randomised to CCE or CTC before colonoscopy. Endoscopists were blinded to the results of CCE and CTC.
RESULTS


Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group. Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group. In the intention-to-screen analysis, sensitivity, specificity and positive and negative predictive values for the identification of individuals with colorectal neoplasia were 98.1%, 76.6%, 93.7% and 92.0% in the CCE group and 64.9%, 95.7%, 96.8% and 57.7% in the CTC group. In terms of detecting significant neoplastic lesions, the sensitivity of CCE and CTC was 96.1% and 79.3%, respectively. Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p = 0.08). Both CCE and CTC identified all patients with cancer. CCE detected more patients with any lesion than CTC (98.6% and 81.0%, respectively; RR = 1.22; p = 0.002).
CONCLUSION


Although both techniques seem to be similar in detecting patients with advanced colorectal neoplasms, CCE is more sensitive for the detection of any neoplastic lesion.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02081742 . Registered: September 16, 2013.",2020,"Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p = 0.08).","['Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group', 'patients with advanced colorectal neoplasms', 'patients with cancer', 'FIT-positive colorectal cancer screening subjects', 'March 2014 to May 2016; 662 individuals were invited and 349 were randomised to', 'colorectal cancer', 'patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT', 'Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group']","['Colon capsule endoscopy (CCE) and CT colonography (CTC', 'CCE or CTC', 'Colon capsule endoscopy versus CT colonography', 'CCE and CTC', 'CCE']","['performance of CCE and CTC in detecting patients with neoplastic lesions', 'sensitivity, specificity and positive and negative predictive values', 'sensitivity of CCE and CTC', 'Detection rate for advanced colorectal neoplasm']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009404', 'cui_str': 'Neoplasm of large intestine'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4727905', 'cui_str': 'Faecal immunochemical test positive'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0935912', 'cui_str': 'Computed Tomographic Colonography'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009404', 'cui_str': 'Neoplasm of large intestine'}]",349.0,0.135465,"Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p = 0.08).","[{'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'González-Suárez', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain. bgonzals@clinic.cat.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Pagés', 'Affiliation': 'Radiology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isis Karina', 'Initials': 'IK', 'LastName': 'Araujo', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Romero', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rodríguez de Miguel', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan Ramón', 'Initials': 'JR', 'LastName': 'Ayuso', 'Affiliation': 'Radiology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Àngels', 'Initials': 'À', 'LastName': 'Pozo', 'Affiliation': 'Department of Preventive Medicine and Epidemiology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vila-Casadesús', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serradesanferm', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.'}, {'ForeName': 'Àngels', 'Initials': 'À', 'LastName': 'Ginès', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Fernández-Esparrach', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pellisé', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'López-Cerón', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Flores', 'Affiliation': 'Radiology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Córdova', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Sendino', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Grau', 'Affiliation': 'Department of Preventive Medicine and Epidemiology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Llach', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Serra-Burriel', 'Affiliation': 'Center for Research in Health and Economic, Pompeu Fabra University, Barcelona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Cárdenas', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Balaguer', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castells', 'Affiliation': 'Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.'}]",BMC medicine,['10.1186/s12916-020-01717-4']
3035,32943079,"Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY).","BACKGROUND


Fatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant proportion of people with schizophrenia (30-60%) reportedly experience fatigue, which impacts negatively on participation in various activities, including work, study, leisure, and social pursuits. Causes of fatigue in schizophrenia are poorly understood and there are no established treatments. Several evidence-based interventions for fatigue syndrome including psychoeducation, cognitive behavioral therapy, and graded exercise therapy have been shown to be effective in other medical conditions and could be adapted to address fatigue in schizophrenia patients. As there are no psychosocial or pharmacological interventions with proved efficacy for fatigue in schizophrenia, there is an urgent need for the development of strategies to improve fatigue management in schizophrenia. The aim of this project is to evaluate in a single blind randomized clinical trial the efficacy of a cognitive-behavioral therapy (CBT) intervention compared to treatment as usual (TAU) on fatigue as the main outcome in schizophrenia patients. Clinical symptoms, physical functioning, major cognitive functions, quality of life and functioning, treatment dosage, daily motor activity, biological markers with inflammatory markers are also considered as secondary outcomes.
METHODS/DESIGN


Two hundred patients meeting the inclusion criteria will be randomized to either of the study arms (intervention or TAU). The ENERGY intervention will be delivered according to a standardized treatment manual comprising six modules addressing fatigue and sleep over 14 individual therapy sessions. The treatment encompasses core CBT principles of psycho-education, behavioral activation, behavioral experiments, cognitive restructuring, problem-solving, and relapse prevention. Sessions will follow the traditional CBT structure of agenda setting, review of homework tasks, and introduction of a new concept/technique with collaborative discussions on how to implement such strategies in the participant's day-to-day environment. Our primary endpoint will be the severity of fatigue assessed at baseline and at the 9-month follow-up using the ""Multidimensional Fatigue Inventory"" (MFI).
DISCUSSION


The trial will provide the first test of CBT intervention for fatigue for patients with schizophrenia. This study will also test to what extent the treatment can be implemented in everyday practice.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04332601 . Registered on 10 April 2020.",2020,"A significant proportion of people with schizophrenia (30-60%) reportedly experience fatigue, which impacts negatively on participation in various activities, including work, study, leisure, and social pursuits.","['schizophrenia patients', 'patients with schizophrenia', 'Two hundred patients meeting the inclusion criteria', 'schizophrenia']","['cognitive-behavioral therapy (CBT) intervention', 'psychoeducation, cognitive behavioral therapy, and graded exercise therapy', 'CBT intervention', 'fatigue management therapy']","['Clinical symptoms, physical functioning, major cognitive functions, quality of life and functioning, treatment dosage, daily motor activity, biological markers with inflammatory markers', 'Multidimensional Fatigue Inventory"" (MFI', 'severity of fatigue']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C2711962', 'cui_str': 'Graded exercise therapy'}, {'cui': 'C0851283', 'cui_str': 'Management of fatigue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",6.0,0.0549178,"A significant proportion of people with schizophrenia (30-60%) reportedly experience fatigue, which impacts negatively on participation in various activities, including work, study, leisure, and social pursuits.","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Raffard', 'Affiliation': 'Univ Paul Valéry Montpellier 3, Univ. Montpellier, EPSYLON EA, Montpellier, France. s-raffard@chu-montpellier.fr.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rainteau', 'Affiliation': 'University Department of Adult Psychiatry, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bayard', 'Affiliation': 'Univ Paul Valéry Montpellier 3, Univ. Montpellier, EPSYLON EA, Montpellier, France.'}, {'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Laraki', 'Affiliation': 'Univ Paul Valéry Montpellier 3, Univ. Montpellier, EPSYLON EA, Montpellier, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Norton', 'Affiliation': 'Inserm, Neuropsychiatry: Epidemiological and Clinical Research, Montpellier, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Capdevielle', 'Affiliation': 'University Department of Adult Psychiatry, CHU Montpellier, Montpellier, France.'}]",Trials,['10.1186/s13063-020-04606-6']
3036,32943085,"Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial.","BACKGROUND


Exercise has been shown to significantly improve pain and function in individuals with fibromyalgia. Research into the effectiveness of exercise is often based on standardised exercise programmes that are chosen by the investigating clinical research team. However, such programmes may not necessarily be appealing to the participating patients. Furthermore, in addition to being taught exercises, patients with chronic conditions like fibromyalgia also need to learn to manage their condition themselves and so be actively involved in their treatment. The primary aim of this study is to compare the effects of two, 6-month physical activity programs on quality of life in patients with fibromyalgia. One group followed a patient-led, fibromyalgia-orientated programme (experimental) whilst the control group followed a standard, general exercise programme.
METHODS


This protocol is an open-label, two-centre, randomised, controlled superiority trial. Two treatment arms will be compared: an experimental group (patient-led, fibromyalgia-orientated exercise) and a control group (general exercise program). The control group will participate in the exercise programme currently provided in our centre, which involves general, group exercise for patients with various pathologies. The experimental group will be taught the principles of exercise specifically for fibromyalgia during a one-to-one coaching session. They will then be guided in the choice of one or several types of exercise that they enjoy. They will be instructed to perform the exercise according to the recommendations for exercise in fibromyalgia with regard to intensity, duration and frequency. The protocol will last for 6 months; participants will then be followed-up for a further 6 months. They will also be encouraged to continue exercising after the end of the protocol. Outcomes will be evaluated at baseline, 6 and 12 months. The primary outcome will be quality of life (Fibromyalgia Impact Questionnaire) and the secondary outcomes will include measures of pain (including a visual analogue scale and the neuropathic characteristics of the pain), depression (Hospital Anxiety and Depression Scale), kinesiophobia (Tampa scale of kinesiophobia) and adherence (Polar OH1 heart rate monitor).
DISCUSSION


The results of this study will show if patient-led, fibromyalgia-orientated exercise is more effective than a general exercise programme on fibromyalgia-related outcomes, including quality of life, and on adherence to continued exercise.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03895086 . Registration no. 2018-A02881-54. Registered on 29 March 2019.",2020,"One group followed a patient-led, fibromyalgia-orientated programme (experimental) whilst the control group followed a standard, general exercise programme.
","['individuals with fibromyalgia', 'patients with chronic conditions like fibromyalgia', 'patients with fibromyalgia']","['fibromyalgia-orientated programme (experimental) whilst the control group followed a standard, general exercise programme', 'general exercise programme', 'physical activity programs', 'experimental group (patient-led, fibromyalgia-orientated exercise) and a control group (general exercise program', 'physical activity program']","['quality of life', 'pain and function', 'quality of life (Fibromyalgia Impact Questionnaire) and the secondary outcomes will include measures of pain (including a visual analogue scale and the neuropathic characteristics of the pain), depression (Hospital Anxiety and Depression Scale), kinesiophobia (Tampa scale of kinesiophobia) and adherence (Polar OH1 heart rate monitor']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",,0.108756,"One group followed a patient-led, fibromyalgia-orientated programme (experimental) whilst the control group followed a standard, general exercise programme.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rulleau', 'Affiliation': 'Unité de Recherche Clinique, CHD-Vendée, La Roche-sur-Yon, France. thomas.rulleau@chd-vendee.fr.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Planche', 'Affiliation': 'Unité de Recherche Clinique, CHD-Vendée, La Roche-sur-Yon, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Etcheverrigaray', 'Affiliation': 'Hopital Bel Air, Service Pharmacie, Courcoué sur Logne, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dorion', 'Affiliation': 'Unité de Recherche Clinique, CHD-Vendée, La Roche-sur-Yon, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kacki', 'Affiliation': 'Unité de Recherche Clinique, CHD-Vendée, La Roche-sur-Yon, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miot', 'Affiliation': 'Groupe Associatif Siel Bleu, Strasbourg, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Liaigre', 'Affiliation': 'Groupe Associatif Siel Bleu, Strasbourg, France.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ganem', 'Affiliation': ""Centre d'Etude et de Traitement de la Douleur, CHD-Vendée, La Roche-sur-Yon, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': ""Centre d'Etude et de Traitement de la Douleur, CHD-Vendée, La Roche-sur-Yon, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Taddéi', 'Affiliation': ""Centre d'Etude et de Traitement de la Douleur, CHD-Vendée, La Roche-sur-Yon, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Acapo', 'Affiliation': 'Laboratoire Thérapeutique EA 3826, CHU Nantes et cabinet de kinésithérapie, 5 rue Nina Simone, 44000, Nantes, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nizard', 'Affiliation': 'Service Douleur Soins Palliatifs et de Support, Médecine intégrative, Unité de Recherche Clinique Douleur et Neurochirurgie, CHU Nantes, et UMR INSERM SPHERE, Nantes, France.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Pluchon', 'Affiliation': ""Centre d'Etude et de Traitement de la Douleur, CHD-Vendée, La Roche-sur-Yon, France.""}]",Trials,['10.1186/s13063-020-04730-3']
3037,32943231,New perspective to improve dentin-adhesive interface stability by using dimethyl sulfoxide wet-bonding and epigallocatechin-3-gallate.,"OBJECTIVES


To determine whether dentin-adhesive interface stability would be improved by dimethyl sulfoxide (DMSO) wet-bonding and epigallocatechin-3-gallate (EGCG).
METHODS


Etched dentin surfaces from sound third molars were randomly assigned to five groups according to different pretreatments: group 1, water wet-bonding (WWB); group 2, 50% (v/v) DMSO wet-bonding (DWB); groups 3-5, 0.01, 0.1, and 1 wt% EGCG-incorporated 50% (v/v) DMSO wet-bonding (0.01%, 0.1%, and 1%EGCG/DWB). Singlebond universal adhesive was applied to the pretreated dentin surfaces, and composite buildups were constructed. Microtensile bond strength (μTBS) and interfacial nanoleakage were respectively examined after 24 h water storage or 1-month collagenase ageing. In situ zymography andStreptococcus mutans (S. mutans) biofilm formation were also investigated.
RESULTS


After collagenase ageing, μTBS of groups 4 (0.1%EGCG/DWB) and 5 (1%EGCG/DWB) did not decrease (p > 0.05) and was higher than that of the other three groups (p < 0.05). Nanoleakage expression of groups 4 and 5 was less than that of the other three groups (p < 0.05), regardless of collagenase ageing. Metalloproteinase activities within the hybrid layer in groups 4 and 5 were suppressed. Furthermore, pretreatment with 1%EGCG/DWB (group 5) efficiently inhibited S. mutans biofilm formation along the dentin-adhesive interface.
SIGNIFICANCE


This study suggested that the synergistic action of DMSO wet-bonding and EGCG can effectively improve dentin-adhesive interface stability. This strategy provides clinicians with promising benefits to achieve desirable dentin bonding performance and to prevent secondary caries, thereby extending the longevity of adhesive restorations.",2020,"Furthermore, pretreatment with 1%EGCG/DWB (group 5) efficiently inhibited S. mutans biofilm formation along the dentin-adhesive interface.
",['Etched dentin surfaces from sound third molars'],"['1%EGCG/DWB', 'DMSO wet-bonding and EGCG', 'dimethyl sulfoxide (DMSO) wet-bonding and epigallocatechin-3-gallate (EGCG', 'dimethyl sulfoxide wet-bonding and epigallocatechin-3-gallate']","['dentin-adhesive interface stability', 'Microtensile bond strength (μTBS) and interfacial nanoleakage', 'Metalloproteinase activities', 'Nanoleakage expression']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0012403', 'cui_str': 'Dimethyl Sulfoxide'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0025543', 'cui_str': 'Metalloproteinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0233387,"Furthermore, pretreatment with 1%EGCG/DWB (group 5) efficiently inhibited S. mutans biofilm formation along the dentin-adhesive interface.
","[{'ForeName': 'Zhongni', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Chenmin', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China.'}, {'ForeName': 'Hongye', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: yanghongye@whu.edu.cn.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) & Key Laboratory for Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, China. Electronic address: huangcui@whu.edu.cn.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.08.009']
3038,32943241,"Specialized oral nutritional supplement (ONS) improves handgrip strength in hospitalized, malnourished older patients with cardiovascular and pulmonary disease: A randomized clinical trial.","BACKGROUND & AIMS


Oral Nutritional Supplements (ONS) are used to treat malnutrition and improve clinical outcomes in malnourished patients. Poor handgrip strength (HGS) is associated with an increased risk of mortality, disability and other adverse health consequences. This analysis examined the effect of a specialized ONS on HGS and its relationship to nutritional status in hospitalized, older adults with malnutrition who were participants in the NOURISH trial.
METHODS


We enrolled older (≥65years), malnourished (Subjective Global Assessment [SGA] class B/C) adults hospitalized for cardiovascular and pulmonary events: congestive heart failure, acute myocardial infarction, pneumonia and/or chronic obstructive pulmonary disease exacerbation in a double-blind, randomized, placebo-controlled trial (NOURISH study). During hospitalization and until 90 days after discharge, participants received standard-of-care plus a high protein and beta-hydroxy-beta-methylbutyrate containing ONS (S-ONS; n = 328) or a placebo supplement (n = 324), aimed at 2 servings/day. HGS was evaluated by dynamometer at baseline, hospital discharge, day (d) 30, d60, and d90 post-discharge.
RESULTS


Post hoc, repeated measures analysis of data at discharge, d30, d60, and d90 showed significantly higher HGS in the S-ONS vs. the placebo group in the evaluable group (Least Squares Means ± Standard Error: (23.25 ± 0.25 vs. 22.63 ± 0.25, p = 0.043). At d90, there was a significant positive association between HGS and nutritional status (SGA) improvements in the entire cohort: 49% of participants with increased HGS from discharge had improved nutritional status versus 31% with unchanged or decreased HGS (p = 0.003). HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits including all ITT subjects (Pearson's r range: 0.24 to 0.34, all p < 0.0001).
CONCLUSIONS


S-ONS provided during hospitalization and up to 90 days post-discharge improves HGS in malnourished older adults following cardiovascular and pulmonary events and may contribute to improvement in patients' overall recovery.
CLINICAL TRIAL REGISTRATION


www.ClinicalTrials.gov NCT01626742.",2020,"HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits including all ITT subjects (Pearson's r range: 0.24 to 0.34, all p < 0.0001).
","['malnourished older adults', 'hospitalized, malnourished older patients with cardiovascular and pulmonary disease', 'enrolled older (≥65years), malnourished (Subjective Global Assessment [SGA] class B/C) adults hospitalized for cardiovascular and pulmonary events: congestive heart failure, acute myocardial infarction, pneumonia and/or chronic obstructive pulmonary disease exacerbation', 'hospitalized, older adults with malnutrition who were participants in the NOURISH trial', 'malnourished patients']","['specialized ONS', 'Specialized oral nutritional supplement (ONS', 'standard-of-care plus a high protein and beta-hydroxy-beta-methylbutyrate containing ONS (S-ONS; n\xa0=\xa0328) or a placebo supplement', 'placebo', 'Oral Nutritional Supplements (ONS']","['Katz index of independence in activities of daily living (ADL', 'HGS', 'handgrip strength', 'HGS and nutritional status (SGA) improvements', 'nutritional status', 'Poor handgrip strength (HGS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0053454', 'cui_str': '3-hydroxyisovaleric acid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.541382,"HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits including all ITT subjects (Pearson's r range: 0.24 to 0.34, all p < 0.0001).
","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Matheson', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Nelson', 'Affiliation': 'Abbott Nutrition, Research and Development, Columbus, OH, USA. Electronic address: jeffrey.l.nelson@abbott.com.'}, {'ForeName': 'Geraldine E', 'Initials': 'GE', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition, Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Menghua', 'Initials': 'M', 'LastName': 'Luo', 'Affiliation': 'Abbott Nutrition, Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Nicolaas E', 'Initials': 'NE', 'LastName': 'Deutz', 'Affiliation': 'Center for Translational Research in Aging & Longevity, Department of Health & Kinesiology, Texas A&M University, College Station, TX, USA.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.035']
3039,32943290,In-Person Contacts and Their Relationship With Alcohol Consumption Among Young Adults With Hazardous Drinking During a Pandemic.,"PURPOSE


Social distancing strategies such as ""stay-at-home"" (SAH) orders can slow the transmission of contagious viruses like the SARS-CoV-2 virus, but require population adherence to be effective. This study explored adherence to SAH orders by young adults with hazardous drinking, and the role of alcohol consumption with in-person contacts on adherence.
METHODS


Analyses included young adults with hazardous drinking (i.e., AUDIT-C score ≥3/4 for women/men; n = 50; ages 18-25) participating in a randomized trial in Pittsburgh, PA. Participants provided experience sampling reports on drinking twice per week from the week before SAH orders started on April 1, 2020 through 6 weeks during the SAH period. We examined how in-person contact with non-household friends changed over time and event-level relationships between alcohol consumption and in-person contacts.
RESULTS


The percentage of participants with any in-person contact in the week before SAH was 44% (95% confidence interval [CI] 30%-59%), which decreased to 29% (95% CI 15%-43%) in the first SAH week and increased to 65% (95% CI 46%-85%) by SAH week 6. Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
CONCLUSIONS


Preliminary data indicate that, among young adults with hazardous drinking, adherence to public policies like SAH orders is suboptimal, declines over time, and is associated with drinking events. Interventions aimed at enhancing young adults' adherence to social distancing policies are urgently needed.",2020,"Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
","['young adults with hazardous drinking, and the role of alcohol consumption with in-person contacts on adherence', 'Analyses included young adults with hazardous drinking (i.e., AUDIT-C score ≥3/4 for women/men; n\xa0= 50; ages 18-25) participating in a randomized trial in Pittsburgh, PA', 'Young Adults With Hazardous Drinking During a Pandemic', 'young adults with hazardous drinking']",[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]",[],[],,0.0502342,"Controlling for average levels of alcohol consumption, on days when young adults drank, participants reported more in-person contacts compared to nondrinking days.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine, Stanford University, Palo Alto, California. Electronic address: suffbp@stanford.edu.'}, {'ForeName': 'Nilam', 'Initials': 'N', 'LastName': 'Ram', 'Affiliation': 'Department of Psychology and Department of Communication, Stanford University, Palo Alto, California.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Robert Wood Johnson School of Medicine, Rutgers University, Brunswick, New Jersey.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.08.007']
3040,32943381,Increased T2 signal intensity in the distal clavicle does not justify acromioclavicular resection arthroplasty during rotator cuff repair.,"INTRODUCTION


Acromioclavicular (AC) arthropathy can contribute to shoulder pain; it can be treated surgically by distal clavicle resection (DCR). The aim of this study was to determine whether increased T2 signal intensity in the clavicle on MRI is an argument in favour of AC resection arthroplasty by DCR during rotator cuff repair.
METHODS


The MRI images from 107 shoulders in 107 patients were analysed. We looked for statistical relationships and correlations between shoulders with T2 hyperintensity (HI+) and those without (HI-) before surgery and then in shoulders with T2 hyperintensity (HI+) that underwent AC resection arthroplasty (AC+) and those who did not (AC-).
RESULTS


On MRI, T2 hyperintensity in the AC joint was correlated with sex (more often found in men) and radiological signs of AC arthropathy. There was no statistical correlation before surgery, particularly with AC pain, or after surgery, with outcomes in shoulders undergoing DCR.
CONCLUSION


When repairing rotator cuff tears, the presence of T2 hyperintensity on MRI in the distal clavicle is not a predictor of better clinical outcomes after AC resection arthroplasty is done. The AC pain may be related to the rotator cuff tear instead.
LEVEL OF EVIDENCE


II, prospective randomised study.",2020,"On MRI, T2 hyperintensity in the AC joint was correlated with sex (more often found in men) and radiological signs of AC arthropathy.","['shoulders with T2 hyperintensity (HI+) and those without (HI-) before surgery and then in shoulders with T2 hyperintensity (HI+) that underwent AC resection arthroplasty (AC+) and those who did not (AC', '107 shoulders in 107 patients were analysed']",[],['T2 signal intensity'],"[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",107.0,0.0330461,"On MRI, T2 hyperintensity in the AC joint was correlated with sex (more often found in men) and radiological signs of AC arthropathy.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Métais', 'Affiliation': 'Hôpital privé La Châtaigneraie, ELSAN, 63110 Beaumont, France. Electronic address: pierremetais@mac.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gallinet', 'Affiliation': 'Centre épaule-main, 16, rue Madeleine Brès, 25000 Besançon, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Labattut', 'Affiliation': 'Service de chirurgie orthopédique, CHU de Dijon, 14, rue PaulGaffarel, 21000 Dijon, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Godenèche', 'Affiliation': 'Ramsay Santé, hôpital privé Jean Mermoz, centre orthopédique Santy, 69008 Lyon, France.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Centre ostéo-articulaire des Cèdres, Parc Sud Galaxie, 5, rue des Tropiques, 38130 Échirolles, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': 'CHP Saint-Grégoire, 35760 Saint-Grégoire, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bonnevialle', 'Affiliation': 'Service de chirurgie orthopédique, CHU de Toulouse, place Baylac, 31059 Toulouse, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Garret', 'Affiliation': 'Clinique du Parc, 155, boulevard Stalingrad, 69006 Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Clavert', 'Affiliation': ""Service de chirurgie de l'épaule et du coude, Hautepierre 2, CHRU de Strasbourg, avenue Molière, 67098 Strasbourg cedex, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': '15, rue Ampère, 92500 Rueil Malmaison, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.08.010']
3041,32943383,Benefits of distal clavicle resection during rotator cuff repair: Prospective randomized single-blind study.,"INTRODUCTION


Rotator cuff tears often occur in combination with acromioclavicular (AC) arthropathy. But it can be difficult to separate pain caused by the rotator cuff tear from pain caused by the AC joint, despite clinical and other examinations. Distal clavicle resection (DCR) is increasingly being done at the same time as arthroscopic rotator cuff repair. The aim of this study was to compare the functional outcomes 1 year after arthroscopic rotator cuff repair between patients who simultaneously undergo DCR and patients who do not. The primary hypothesis was that DCR improves the clinical outcomes.
MATERIAL AND METHODS


This was a prospective, multicenter, randomized, single-blind study of 200 patients who underwent isolated supraspinatus repair using the same technique. The patients were randomized into two groups: 97 patients who also underwent DCR and 103 patients who did not. The patients were followed until 1 year postoperative according to a standardized radiological and clinical review protocol.
RESULTS


At 1 year postoperative, all the clinical outcomes were worse in the DCR group, although only external rotation with elbow at side (53° vs. 59°, p=0.04) and the SSV (86.5 vs. 90.1, p=0.04) were statistically different. Overall shoulder pain was higher in the DCR group during the first 3 months postoperative (p=0.04). At 1 year, the DCR group had more residual pain; this pain was mainly located on the superior side of the shoulder (p=0.03), especially when more than 11 mm was resected (p=0.01). More of the shoulders in the DCR group had failures in rotator cuff healing based on ultrasonography (p=0.5).
CONCLUSION


Our hypothesis was not confirmed. We do not recommend doing routine DCR with arthroscopic rotator cuff repair.
LEVEL OF EVIDENCE


I, prospective randomized simple blind study.",2020,Overall shoulder pain was higher in the DCR group during the first 3 months postoperative (p=0.04).,"['97 patients who also underwent DCR and 103 patients who did not', 'rotator cuff repair', '200 patients who underwent isolated supraspinatus repair using the same technique', 'patients who simultaneously undergo DCR and patients who do not']","['distal clavicle resection', 'arthroscopic rotator cuff repair', 'Distal clavicle resection (DCR']","['external rotation with elbow at side', 'rotator cuff healing', 'residual pain; this pain', 'Overall shoulder pain', 'SSV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0186434', 'cui_str': 'Resection of clavicle'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0186434', 'cui_str': 'Resection of clavicle'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C3805255', 'cui_str': 'Residual pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0751995', 'cui_str': 'Genes, PDGFB'}]",200.0,0.0673519,Overall shoulder pain was higher in the DCR group during the first 3 months postoperative (p=0.04).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gallinet', 'Affiliation': 'Centre Épaule Main Besançon, 16, rue Madeleine Brès, 25000 Besançon, France. Electronic address: contact@docteurgallinet.com.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': 'Centre ostéoarticulaire des Cèdres, Parc Sud Galaxie, 5, rue des Tropiques, 38130 Echirolles, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Labattut', 'Affiliation': 'Service de Chirurgie Orthopédique et Traumatologique, Hôpital François Mitterrand CHU de Dijon, 14, rue Gaffarel, BP 77908, 21079 Dijon cedex, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': ""Institut locomoteur de l'ouest, 7, boulevard de la Boutière, 35760 Saint Grégoire, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Metais', 'Affiliation': 'Elsan Hôpital privé la Châtaigneraie, 63110 Beaumont, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bonnevialle', 'Affiliation': 'Hôpital Pierre Paul Riquet, CHRU de Toulouse, place Baylac, 31059 Toulouse, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Godeneche', 'Affiliation': 'Centre Orthopédique Santy, 24, avenue Paul Santy, 69008 Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Garret', 'Affiliation': 'Clinique du Parc, 155, boulevard Stalingrad, 69006 Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Clavert', 'Affiliation': 'Service de chirurgie du membre supérieur, Hautepierre 2, CHRU Strasbourg, avenue Molière, 67200 Strasbourg, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': '15, rue Ampère, 92500 Rueil Malmaison, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.08.006']
3042,32943769,"Cognitive performance, mood and satiety following ingestion of beverages imparting different glycaemic responses: a randomised double-blind crossover trial.","BACKGROUND/OBJECTIVE


The relationship between postprandial glycaemic responses and cognitive performance, mood and satiety are inconsistent. The objective of this study is to compare the effects of different glycaemic responses, induced by beverages with different glycaemic index (GI) (sucrose and isomaltulose), and a non-glycaemic control (sucralose), on cognition, mood and satiety.
SUBJECTS/METHODS


In this double-blinded, randomised crossover trial, healthy adults (n = 55) received sucrose (GI 65), isomaltulose (GI 32) and sucralose (non-caloric negative control) drinks on separate occasions. The Complex Figure test, the Word Recall test, Trail Making Test Part B and the Stroop test were administered 60 min after beverages ingestion. Mood and satiety were tested along with cognitive performance.
RESULTS


Comparing between isomaltulose and sucrose, there were no significant differences in the mean (95% CI) for the following: Complex Figure: immediate recall -0.6 (-1.7, 0.5), delayed recall -0.8 (-1.9, 0.3); Word recall: immediate recall 0.2 (-0.7, 1.1), delayed recall 0.5 (-0.4, 1.4); Trail Making: completing time -2.4 (-7.5, 2.7) s; Stroop: time used for correct congruent responses -9 (-31, 14) ms and correct incongruent responses -18 (-42, 6) ms. No differences among beverages were found in the mood and satiety scores with exception that participants felt more energetic 60 min after isomaltulose ingestion (p = 0.028 for difference with sucrose) and hungrier 30 min after isomaltulose ingestion (p = 0.036 for difference with sucrose; p = 0.022 for difference with sucralose).
CONCLUSION


Under these study conditions there is no convincing evidence for an effect of glycaemic response on cognitive performance, mood or satiety.",2020,"No differences among beverages were found in the mood and satiety scores with exception that participants felt more energetic 60 min after isomaltulose ingestion (p = 0.028 for difference with sucrose) and hungrier 30 min after isomaltulose ingestion (p = 0.036 for difference with sucrose; p = 0.022 for difference with sucralose).
",['healthy adults (n\u2009=\u200955) received'],"['beverages with different glycaemic index (GI) (sucrose and isomaltulose), and a non-glycaemic control (sucralose', 'sucrose (GI 65), isomaltulose (GI 32) and sucralose (non-caloric negative control) drinks']","['Mood and satiety', 'cognitive performance, mood or satiety', 'correct congruent responses -9 (-31, 14)\u2009ms and correct incongruent responses -18', 'postprandial glycaemic responses and cognitive performance, mood and satiety', 'Cognitive performance, mood and satiety following ingestion of beverages imparting different glycaemic responses', 'cognition, mood and satiety', 'mood and satiety scores']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0064002', 'cui_str': 'isomaltulose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.415291,"No differences among beverages were found in the mood and satiety scores with exception that participants felt more energetic 60 min after isomaltulose ingestion (p = 0.028 for difference with sucrose) and hungrier 30 min after isomaltulose ingestion (p = 0.036 for difference with sucrose; p = 0.022 for difference with sucralose).
","[{'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Deng', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jillian J', 'Initials': 'JJ', 'LastName': 'Haszard', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Rapsey', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Food Science, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Venn', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand. bernard.venn@otago.ac.nz.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00749-6']
3043,32943843,"Application of Intravenous Lidocaine in Obese Patients Undergoing Painless Colonoscopy: A Prospective, Randomized, Double-Blind, Controlled Study.","Objective


Propofol for procedural sedation and analgesia (PSA) for colonoscopy can result in a high prevalence of severe respiratory depression. Studies have shown that intravenous (IV) infusion of lidocaine can reduce propofol requirements significantly and increase the ventilatory response to carbon dioxide in humans. We tested the hypothesis that IV lidocaine could improve propofol-induced respiratory depression in obese patients during colonoscopy.
Methods


Ninety obese patients scheduled for painless colonoscopy were randomized to receive lidocaine (1.5 mg/kg, then 2 mg/kg/h, IV) or the same volume of 0.9% saline. Intraoperative sedation was provided by propofol. The primary outcome was the number of oxygen-desaturation episodes. Secondary outcomes were: the number of apnea episodes; total propofol consumption; time to the first hypoxia episode; time to consciousness loss; intraoperative hemodynamic parameters; awakening time; adverse events; duration of post-anesthesia care unit (PACU) stay; satisfaction of endoscopists and patients.
Results


Demographic characteristics between the two groups were comparable. The number of oxygen-desaturation episodes in group L (1.49±1.12) decreased by 0.622 ( P =0.018) compared with that in group N (2.11±1.32), and the number of apnea episodes in group L decreased by 0.533 ( P <0.001). Kaplan-Meier curves showed that the median time to the first hypoxia episode was longer in group L (86.78 s) than that in group N (63.83 s) (Log rank  P =0.0008). The total propofol consumption, awakening time, and duration of PACU stay were reduced in group L. There was no significant difference in the prevalence of adverse events ( P >0.05 for all). Satisfaction scores for endoscopists and patients in group L were higher than that in group N ( P <0.001).
Conclusion


Intravenous infusion of lidocaine could significantly reduce the number of oxygen-desaturation and apnea episodes in obese patients during painless colonoscopy. This method is worthy of clinical promotion.
Clinical Trials Registration


ChiCTR2000028937.",2020,"Satisfaction scores for endoscopists and patients in group L were higher than that in group N ( P <0.001).
","['obese patients during colonoscopy', 'Ninety obese patients scheduled for painless colonoscopy', 'obese patients during painless colonoscopy', 'Obese Patients Undergoing Painless Colonoscopy']","['propofol', 'Intravenous Lidocaine', 'lidocaine', 'Propofol']","['prevalence of adverse events', 'Satisfaction scores', 'number of apnea episodes', 'total propofol consumption, awakening time, and duration of PACU stay', 'Intraoperative sedation', 'number of oxygen-desaturation and apnea episodes', 'ventilatory response', 'number of oxygen-desaturation episodes', 'number of apnea episodes; total propofol consumption; time to the first hypoxia episode; time to consciousness loss; intraoperative hemodynamic parameters; awakening time; adverse events; duration of post-anesthesia care unit (PACU) stay; satisfaction of endoscopists and patients']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0234226', 'cui_str': 'Painless'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",90.0,0.103781,"Satisfaction scores for endoscopists and patients in group L were higher than that in group N ( P <0.001).
","[{'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhenfei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Nie', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Lianyi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S266062']
3044,32943847,Post-Arthroscopic Rotator Cuff Repair Rehabilitation Booklet: A Patient-Based Evaluation.,"Background


Lack of physical therapists has led to increment of self-managed rehabilitations in post-arthroscopic rotator cuff repair (ARCR) in the forms of booklets or leaflets.
Purpose


The aim of study is to investigate 1) the acceptance of post-ARCR patients towards an education booklet, and 2) whether it could be a timesaving and laborsaving tool to physical therapists.
Methods


An education booklet was established through a systematic review. Patients who underwent ARCR in our hospital were included and randomly assigned to the intervention or control group (27 women, 21 men, mean age=57.06 years old). Patients in the intervention group received educational booklets, and an evaluation was also obtained after they finished reading. Patients' understanding of the booklet was determined by asking patients to re-enact training presented in the booklet. Then, a therapist blinded to allocations would personally demonstrate training to patients until patients fully understood the protocol. For the control group, the same therapist coached patients until the whole protocol was clearly understood. The coaching time for patients in both groups was recorded.
Results


Out of 48 patients, 24 (50%) were randomly assigned to the intervention group, and 21 (87.50%) completed their questionnaire. Out of these 21 patients, 20 (95.24%) rated the booklet as ""excellent and easy to read"", and 17 (80.95%) felt that the booklet was helpful. The re-enaction accuracy was for strengthening training and specific training (71.43% and 61.90%, respectively). As compared to the control group, the time of coaching for the patients to fully master the protocol in the intervention group was significantly less ( P <0.01).
Conclusion


Patients highly applauded this booklet, and they cherished the information and support it contained. Nevertheless, the re-enaction accuracy was not high, suggesting that the high level of acceptance does not guarantee full understanding of information sent to patients.",2020,Patients' understanding of the booklet was determined by asking patients to re-enact training presented in the booklet.,"['Patients who underwent ARCR in our hospital were included and randomly assigned to the intervention or control group (27 women, 21 men, mean age=57.06 years old', '48 patients, 24 (50']","['Arthroscopic Rotator Cuff Repair Rehabilitation Booklet', 'strengthening training and specific training', 'educational booklets']",['time of coaching'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}]",48.0,0.0363005,Patients' understanding of the booklet was determined by asking patients to re-enact training presented in the booklet.,"[{'ForeName': 'Congda', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qingyue', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Fangqi', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yuanhao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yiyong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': ""Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}]",Patient preference and adherence,['10.2147/PPA.S263645']
3045,32943858,Geriatric Interdisciplinary Home Rehabilitation After Hip Fracture in People with Dementia - A Subgroup Analysis of a Randomized Controlled Trial.,"Purpose


To investigate if the effects of geriatric interdisciplinary home rehabilitation after hip fracture were different among people with dementia compared to those without dementia and to describe the overall outcome after hip fracture in people with dementia.
Patients and Methods


A post hoc subgroup analysis of a randomized controlled trial was conducted including 205 people with hip fracture, aged ≥70, living in ordinary housing or residential care facilities. Early discharge followed by individually designed interdisciplinary home rehabilitation for a maximum of 10 weeks was compared to in-hospital geriatric care according to a multifactorial rehabilitation program. Outcomes were hospital length of stay (LOS), readmissions, falls, mortality, performance in activities of daily living (ADL), and walking ability.
Results


Interdisciplinary home rehabilitation vs in-hospital care had comparable effects on falls and mortality between discharge and 12 months and on ADL and walking ability at 3 and 12 months regardless of whether the participants had dementia or not ( P ≥0.05 for all). Among participants with dementia, postoperative LOS was a median of 18 days (interquartile range [IQR] 14-30) in the home rehabilitation group vs 23 days (IQR 15-30) in the control group ( P =0.254) with comparable numbers of readmissions after discharge. Dementia was associated with increased risk of falling (odds ratio [OR] 3.86; 95% confidence interval [CI]: 2.05-7.27;  P <0.001) and increased mortality (OR 4.20; 95% CI 1.79-9.92,  P =0.001) between discharge and 12 months and with greater dependence in ADL and walking at 3 and 12 months compared to participants without dementia ( P <0.001 for all).
Conclusion


The effects of geriatric interdisciplinary home rehabilitation vs in-hospital geriatric care did not differ in participants with and without dementia. However, the statistical power of this subgroup analysis was likely insufficient to detect differences between the groups. Dementia was associated with a substantial negative impact on the outcomes following the hip fracture. Our findings support offering interdisciplinary home rehabilitation after hip fracture to people with dementia.",2020,"Results


Interdisciplinary home rehabilitation vs in-hospital care had comparable effects on falls and mortality between discharge and 12 months and on ADL and walking ability at 3 and 12 months regardless of whether the participants had dementia or not ( P ≥0.05 for all).","['people with dementia', '205 people with hip fracture, aged ≥70, living in ordinary housing or residential care facilities', 'after hip fracture to people with dementia', 'participants with and without dementia']","['interdisciplinary home rehabilitation', 'geriatric interdisciplinary home rehabilitation', 'Geriatric Interdisciplinary Home Rehabilitation']","['risk of falling', 'ADL and walking ability', 'falls and mortality', 'mortality', 'hospital length of stay (LOS), readmissions, falls, mortality, performance in activities of daily living (ADL), and walking ability', 'postoperative LOS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",205.0,0.177108,"Results


Interdisciplinary home rehabilitation vs in-hospital care had comparable effects on falls and mortality between discharge and 12 months and on ADL and walking ability at 3 and 12 months regardless of whether the participants had dementia or not ( P ≥0.05 for all).","[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Karlsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine and Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Berggren', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Olofsson', 'Affiliation': 'Department of Nursing and Department of Surgical and Perioperative Science, Orthopedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stenvall', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lindelöf', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine and Physiotherapy, Umeå University, Umeå, Sweden.'}]",Clinical interventions in aging,['10.2147/CIA.S250809']
3046,32943910,Erratum: Effect of Ultrasound-Guided Peripheral Nerve Blocks of the Abdominal Wall on Pain Relief After Laparoscopic Cholecystectomy [Corrigendum].,[This corrects the article DOI: 10.2147/JPR.S203721.].,2020,[This corrects the article DOI: 10.2147/JPR.S203721.].,[],"['Laparoscopic Cholecystectomy [Corrigendum', 'Ultrasound-Guided Peripheral Nerve Blocks']",['Pain Relief'],[],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.0204548,[This corrects the article DOI: 10.2147/JPR.S203721.].,[],Journal of pain research,['10.2147/JPR.S278204']
3047,32944273,Mind the gap: an intervention to support caregivers with a new autism spectrum disorder diagnosis is feasible and acceptable.,"Introduction


Children with autism spectrum disorder (ASD) benefit when their caregivers can effectively advocate for appropriate services. Barriers to caregiver engagement such as provider mistrust, cultural differences, stigma, and lack of knowledge can interfere with timely service access. We describe Mind the Gap (MTG), an intervention that provides education about ASD, service navigation, and other topics relevant to families whose children have a new ASD diagnosis. MTG was developed via community partnerships and is explicitly structured to reduce engagement barriers (e.g., through peer matching, meeting flexibility, culturally-informed practices). We also present on the results of a pilot of MTG, conducted in preparation for a randomized controlled trial.
Methods


MTG was evaluated using mixed methods that included qualitative analysis and pre/post-test without concurrent comparison group. Participants (n=9) were primary caregivers of children (ages 2-7 years) with a recent ASD diagnosis and whose annual income was at or below 185% of the federal poverty level. In order to facilitate trust and relationship building, peer coaches delivered MTG. The coaches were parents of children with ASD who we trained to deliver the intervention. MTG consisted of up to 12 meetings between coaches and caregivers over the course of 18 weeks. Coaches delivered the intervention in homes and other community locations. Coaches shared information about various ""modules,"" which were topics identified as important for families with a new ASD diagnosis. Coaches worked with families to answer questions, set weekly goals, assess progress, and offer guidance. For the pilot, we focused on three primary outcomes: feasibility, engagement, and satisfaction. Feasibility was measured via enrollment and retention data, as well as coach fidelity (i.e., implementation of MTG procedures). Engagement was measured via number of sessions attended and percentage completion of the selected outcome measures. For completers (n=7), satisfaction was measured via a questionnaire (completed by caregivers) and open-ended interviews (completed by caregivers and coaches).
Results


We enrolled 56% of referred caregivers and 100% of eligible families. Retention was high (78%). Coaches could deliver the intervention with fidelity, completing, on average, 83% of program components. Engagement also was high; caregivers attended an average of 85% of total possible sessions and completed 100% of their measures. Caregivers indicated moderately high satisfaction with MTG. Qualitative data indicated that caregivers and coaches were positive about intervention content, and the coach-caregiver relationship was important. They also had suggestions for changes.
Conclusion


Mind the Gap demonstrates evidence of feasibility, and data from the pilot suggest that it addresses intervention engagement barriers for a population that is under-represented in research. The results and suggestions from participants were used to inform a large-scale RCT, which is currently underway. Overall, MTG shows promise as an intervention that can be feasibly implemented with under-resourced and ethnic minority families of children with ASD.
Trial registration


This study is registered with ClinicalTrials.gov: NCT03711799.",2020,"Overall, MTG shows promise as an intervention that can be feasibly implemented with under-resourced and ethnic minority families of children with ASD.
","['We enrolled 56% of referred caregivers and 100% of eligible families', 'Participants (n=9) were primary caregivers of children (ages 2-7 years) with a recent ASD diagnosis and whose annual income was at or below 185% of the federal poverty level', 'Children with autism spectrum disorder (ASD']",[],[],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],9.0,0.180796,"Overall, MTG shows promise as an intervention that can be feasibly implemented with under-resourced and ethnic minority families of children with ASD.
","[{'ForeName': 'Suzannah', 'Initials': 'S', 'LastName': 'Iadarola', 'Affiliation': 'University of Rochester Medical Center, 601 Elmwood Ave, Box 671, Rochester, NY 14642 USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pellecchia', 'Affiliation': 'University of Pennsylvania, 3535 Market St, 3rd floor, Philadelphia, PA 19104 USA.'}, {'ForeName': 'Aubyn', 'Initials': 'A', 'LastName': 'Stahmer', 'Affiliation': 'University of California, Davis, 2825 50th St, Sacramento, CA 95817 USA.'}, {'ForeName': 'Hyon Soo', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'University of California, Los Angeles, UCLA Semel Institute 68-268, Los Angeles, CA 90024 USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Hauptman', 'Affiliation': 'University of California, Los Angeles, UCLA Semel Institute 68-268, Los Angeles, CA 90024 USA.'}, {'ForeName': 'Elizabeth McGhee', 'Initials': 'EM', 'LastName': 'Hassrick', 'Affiliation': 'Drexel University, 3020 Market Street | Suite 560, Philadelphia, PA 19104 USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Crabbe', 'Affiliation': 'University of Pennsylvania, 3535 Market St, 3rd floor, Philadelphia, PA 19104 USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vejnoska', 'Affiliation': 'University of California, Davis, 2825 50th St, Sacramento, CA 95817 USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morgan', 'Affiliation': 'University of California, Davis, 2825 50th St, Sacramento, CA 95817 USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Nuske', 'Affiliation': 'University of Pennsylvania, 3535 Market St, 3rd floor, Philadelphia, PA 19104 USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Luelmo', 'Affiliation': 'San Diego State University, 5500 Campanile Dr, San Diego, CA 92182 USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Friedman', 'Affiliation': 'Drexel University, 3020 Market Street | Suite 560, Philadelphia, PA 19104 USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Kasari', 'Affiliation': 'University of California, Davis, 2825 50th St, Sacramento, CA 95817 USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Gulsrud', 'Affiliation': 'University of California, Los Angeles, UCLA Semel Institute 68-268, Los Angeles, CA 90024 USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mandell', 'Affiliation': 'University of Pennsylvania, 3535 Market St, 3rd floor, Philadelphia, PA 19104 USA.'}, {'ForeName': 'Tristram', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'University of Rochester Medical Center, 601 Elmwood Ave, Box 671, Rochester, NY 14642 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00662-6']
3048,32944274,Feasibility and acceptability of a televideo physical activity and nutrition program for recent kidney transplant recipients.,"Background


Post-transplant weight gain affects 50-90% of kidney transplant recipients adversely affecting survival, quality of life, and risk for diabetes and cardiovascular disease. Diet modification and physical activity may help prevent post-transplant weight gain. Methods for effective implementation of these lifestyle modifications are needed. The objective of this study is to assess the feasibility and acceptability of a remotely delivered nutrition and physical activity intervention among kidney transplant recipients. Secondary aims were to estimate the effectiveness of the intervention in producing changes in physical activity, qualify of life, fruit and vegetable intake, and consumption of whole grains and water from baseline to 6 months.
Methods


A randomized controlled study for stable kidney transplant recipients between 6 and 12 months post-transplantation was conducted. Participants were randomly assigned 1:1 to a technology-based, lifestyle modification program (intervention) or to enhanced usual care (control).
Results


The first 10 kidney transplant recipients screened were eligible and randomized into the intervention and control groups with no significant between-group differences at baseline. Health coaching attendance (78%) and adherence to reporting healthy behaviors (86%) were high. All participants returned for final assessments. The weight in controls remained stable, while the intervention arm showed weight gain at 3 and 6 months. Improvements were found for physical activity, quality of life, and fruit and vegetable intake in both groups. All participants would recommend the program to other transplant recipients.
Conclusions


Our data suggest that a remotely delivered televideo nutrition and physical activity intervention is feasible and valued by patients. These findings will aid in the development of a larger, more prescriptive, randomized trial to address weight gain prevention.
Trial registration


Clinicaltrials.gov Identifier NCT03697317. Retrospectively registered on October 5, 2018.",2020,"Improvements were found for physical activity, quality of life, and fruit and vegetable intake in both groups.","['recent kidney transplant recipients', '10 kidney transplant recipients screened', 'stable kidney transplant recipients between 6 and 12 months post-transplantation was conducted', 'kidney transplant recipients']","['technology-based, lifestyle modification program (intervention) or to enhanced usual care (control', 'remotely delivered nutrition and physical activity intervention', 'televideo physical activity and nutrition program', 'televideo nutrition and physical activity intervention']","['weight gain', 'physical activity, qualify of life, fruit and vegetable intake, and consumption of whole grains and water from baseline to 6 months', 'adherence to reporting healthy behaviors', 'physical activity, quality of life, and fruit and vegetable intake', 'survival, quality of life, and risk for diabetes and cardiovascular disease', 'feasibility and acceptability', 'Health coaching attendance']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0346775,"Improvements were found for physical activity, quality of life, and fruit and vegetable intake in both groups.","[{'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'Gibson', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., MS1020, Kansas City, KS 66160 USA.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology and Hypertension, Kidney Institute, University of Kansas Medical Center, Kansas City, KS USA.'}, {'ForeName': 'J Leon', 'Initials': 'JL', 'LastName': 'Greene', 'Affiliation': 'Department of Health, Sports, and Exercise Sciences, University of Kansas, Lawrence, KS USA.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, Lubbock, TX USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Mount', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., MS1020, Kansas City, KS 66160 USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Sullivan', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00672-4']
3049,32944276,Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial.,"Background


Sleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia.
Methods


This is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis.
Discussion


This research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial.
Trial registration


ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.",2020,A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio.,"['pregnant women', 'pregnant women in remission from depression self-manage insomnia', '50 pregnant women between 12 and 28\u2009weeks gestation will be recruited from the community']","['online mindfulness meditation intervention', 'mindfulness or education-only control group', 'mindfulness meditation and cognitive-behavioral therapy']","['sleep quality measured with the Pittsburgh Sleep Quality Index', 'daily function, mood, and pregnancy and birth outcomes', 'include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness', 'study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.157991,A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio.,"[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Kantrowitz-Gordon', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington, Box 357262, Seattle, WA 98195 USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McCurry', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington, Box 357262, Seattle, WA 98195 USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Landis', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, Box 357266, Seattle, WA 98195 USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington, Box 357262, Seattle, WA 98195 USA.'}, {'ForeName': 'Dahee', 'Initials': 'D', 'LastName': 'Wi', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington, Box 357262, Seattle, WA 98195 USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00675-1']
3050,32944277,Feasibility of the PalliSupport care pathway: results from a mixed-method study in acutely hospitalized older patients at the end of life.,"Background


A transitional care pathway (TCP) could improve care for older patients in the last months of life. However, barriers exist such as unidentified palliative care needs and suboptimal collaboration between care settings. The aim of this study was to determine the feasibility of a TCP, named PalliSupport, for older patients at the end of life, prior to a stepped-wedge randomized controlled trial.
Methods


A mixed-method feasibility study was conducted at one hospital with affiliated primary care. Patients were ≥ 60 years and acutely hospitalized. The intervention consisted of (1) training on early identification of the palliative phase and end of life conversations, (2) involvement of a transitional palliative care team during admission and post-discharge and (3) intensified collaboration between care settings. Outcomes were feasibility of recruitment, data collection, patient burden and protocol adherence. Experiences of 14 professionals were assessed through qualitative interviews.
Results


Only 16% of anticipated participants were included which resulted in difficulty assessing other feasibility criteria. The qualitative analysis identified misunderstandings about palliative care, uncertainty about professionals' roles and difficulties in initiating end of life conversations as barriers. The training program was well received and professionals found the intensified collaboration beneficial for patient care. The patients that participated experienced low burden and data collection on primary outcomes and protocol adherence seems feasible.
Discussion


This study highlights the importance of performing a feasibility study prior to embarking on effectiveness studies. Moving forward, the PalliSupport care pathway will be adjusted to incorporate a more active recruitment approach, additional training on identification and palliative care, and further improvement on data collection.",2020,"Moving forward, the PalliSupport care pathway will be adjusted to incorporate a more active recruitment approach, additional training on identification and palliative care, and further improvement on data collection.","['older patients at the end of life, prior to a stepped-wedge randomized controlled trial', 'Patients were ≥ 60\u2009years and acutely hospitalized', 'one hospital with affiliated primary care', 'acutely hospitalized older patients at the end of life']","['\n\n\nA transitional care pathway (TCP', 'PalliSupport care pathway', 'TCP, named PalliSupport', 'intervention consisted of (1) training on early identification of the palliative phase and end of life conversations, (2) involvement of a transitional palliative care team during admission and post-discharge and (3) intensified collaboration between care settings']","['feasibility of recruitment, data collection, patient burden and protocol adherence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0585045', 'cui_str': 'During admission'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0499825,"Moving forward, the PalliSupport care pathway will be adjusted to incorporate a more active recruitment approach, additional training on identification and palliative care, and further improvement on data collection.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Flierman', 'Affiliation': 'Amsterdam UMC, Department of General Practice, Section of Medical Ethics, Amsterdam Public Health research institute, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'van Rijn', 'Affiliation': 'Amsterdam UMC, Department of Internal Medicine, Section of Geriatric Medicine, Amsterdam Public Health research institute, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'de Meij', 'Affiliation': 'OLVG, Palliative and Supportive Care Team, Oncology Centre Amsterdam, Oosterpark 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Poels', 'Affiliation': 'Care2research, Mattenbiesstraat 133, Amsterdam, the Netherlands.'}, {'ForeName': 'Dorende M', 'Initials': 'DM', 'LastName': 'Niezink', 'Affiliation': 'Amsterdam UMC, Department of Internal Medicine, Section of Geriatric Medicine, Amsterdam Public Health research institute, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Dick L', 'Initials': 'DL', 'LastName': 'Willems', 'Affiliation': 'Amsterdam UMC, Department of General Practice, Section of Medical Ethics, Amsterdam Public Health research institute, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Buurman', 'Affiliation': 'Amsterdam UMC, Department of Internal Medicine, Section of Geriatric Medicine, Amsterdam Public Health research institute, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00676-0']
3051,32942192,Cluster randomized controlled trial (RCT) to support parental contact for children in out-of-home care.,"BACKGROUND


There is an identified need to improve the evidence-base in relation to contact visits for children in the out-of-home-care (OOHC) system, to ensure optimal outcomes.
OBJECTIVE


The aim of this cluster randomized controlled trial (RCT) was to test the effectiveness of a contact intervention for parents having supervised contact with children in long-term OOHC.
PARTICIPANTS


183 study children in 15 clusters (OOHC services) and their parent(s) were randomized to the intervention (8 clusters, 100 children) and control groups (7 clusters, 83 children) in three Australian jurisdictions.
SETTING


The manualized intervention consisted of increasing the preparation and support provided by caseworkers to parents before and after their contact visits.
METHOD


Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization. Interviews included standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent.
RESULTS


Compared with controls, the intention-to-treat (ITT) analyses showed that fewer visits were cancelled by parents in the intervention group at follow-up (-10.27; 95 % CI: -17.04 to -3.50, p = .006). In addition, per-protocol (PP) analyses showed higher caseworker receptivity to contact (6.03; 95 % CI: 0.04-12.03, p = .04), and higher parent satisfaction with contact (7.41; 95 % CI: 0.70-14.11, p = .03) in the intervention group at follow-up.
CONCLUSIONS


While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits. The findings of the current study provide an important contribution to knowledge in an area where few RCTs have been completed, notwithstanding the null findings.",2020,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","['parents having supervised contact with children in long-term OOHC', 'children in out-of-home care', 'Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization', '183 study children in 15 clusters (OOHC services) and their parent(s']","['kC kContact intervention', 'contact intervention']","['standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent', 'caseworker receptivity', 'child wellbeing']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",183.0,0.11973,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Suomi', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia; Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'McArthur', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dobbins', 'Affiliation': 'School of Public Health and Community Medicine, The University of New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taplin', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia. Electronic address: stephanie.taplin@acu.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104708']
3052,32942203,Examining the effectiveness of an online program to cultivate mindfulness and self-compassion skills (Mind-OP): Randomized controlled trial on Amazon's Mechanical Turk.,"OBJECTIVES


The demand for effective psychological treatments for depression, anxiety, and heightened stress is far outstripping their supply. Accordingly, internet delivered, self-help interventions offer hope to many people, as they can be easily accessed and at a fraction of the price of face-to-face options. Mindfulness and self-compassion are particularly exciting approaches, as evidence suggests interventions that cultivate these skills are effective in reducing depression, anxiety, and heightened stress. We examined the effectiveness of a newly developed program that combines mindfulness, self-compassion, and goal-setting exercises into a brief self-guided intervention (Mind-OP). The secondary aim of this study was to investigate the feasibility of conducting a randomized-controlled trial entirely on a popular crowdsourcing platform, Amazon's Mechanical Turk (MTurk).
METHODS


We randomized 456 participants reporting heightened depression, anxiety, or stress to one of two conditions: the 4-week Mind-OP intervention (n = 227) or to an active control condition (n = 229) where participants watched nature videos superimposed onto relaxing meditation music for four consecutive weeks. We administered measures of anxiety, depression, perceived stress, dispositional and state mindfulness, self-compassion, and nonattachment.
RESULTS


Intent-to-treat and per-protocol analyses revealed that, compared to participants in the control condition, participants in the Mind-OP intervention condition reported significantly less anxiety and stress at the end of the trial, as well as significantly greater mindfulness, self-compassion, and nonattachment.
CONCLUSIONS


Mind-OP appears effective in reducing anxiety symptoms and perceived stress among MTurk participants. We highlight issues (e.g., attrition) related to feasibility of conducting randomized trials on crowdsourcing platforms such as MTurk.",2020,"CONCLUSIONS


Mind-OP appears effective in reducing anxiety symptoms and perceived stress among MTurk participants.","['MTurk participants', '456 participants reporting heightened depression, anxiety, or stress to one of two conditions: the']","[""Amazon's Mechanical Turk"", ""popular crowdsourcing platform, Amazon's Mechanical Turk (MTurk"", 'online program to cultivate mindfulness and self-compassion skills (Mind-OP', '4-week Mind-OP intervention (n\xa0=\xa0227) or to an active control condition (n\xa0=\xa0229) where participants watched nature videos superimposed onto relaxing meditation music']","['anxiety, depression, perceived stress, dispositional and state mindfulness, self-compassion, and nonattachment', 'anxiety symptoms and perceived stress', 'anxiety and stress', 'mindfulness, self-compassion, and nonattachment']","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",456.0,0.0376572,"CONCLUSIONS


Mind-OP appears effective in reducing anxiety symptoms and perceived stress among MTurk participants.","[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Beshai', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada. Electronic address: shadi.beshai@uregina.ca.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bueno', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Feeney', 'Affiliation': 'Department of Management and Marketing, School of Business, Rhode Island College, 600 Mount Pleasant Avenue Providence, RI 02908, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Pitariu', 'Affiliation': 'Faculty of Business Administration, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103724']
3053,30476007,"Human Immunodeficiency Virus (HIV)-1 Transmission Among Persons With Acute HIV-1 Infection in Malawi: Demographic, Behavioral, and Phylogenetic Relationships.","BACKGROUND


Understanding sexual networks involving acute human immunodeficiency virus (HIV)-1 infections (AHI) may lead to prevention opportunities to mitigate high rates of onward transmission. We evaluated HIV-1 phylogenetic and behavioral characteristics among persons with AHI and their referred partners.
METHODS


Between 2012 and 2014, 46 persons with AHI in Malawi participated in a combined behavioral and biomedical intervention. Participants referred sexual partners by passive referral. Demographics and sexual behaviors were collected through interviews and HIV-1 genetic relationships were assessed with phylogenetics.
RESULTS


Among 45 AHI participants with HIV-1 sequences, none was phylogenetically-linked with another AHI index. There were 19 (42%) AHI participants who referred a single partner that returned for testing. Most partners (n = 17) were HIV-infected, with 15 (88%) presenting with an established infection. There were 14 index-partner pairs that had sequences available; 13 (93%) pairs were phylogenetically-linked dyads. The AHI index was female in 7/13 (54%) dyads. Age-disparate relationships among dyads were common (≥5-year age difference in 67% of dyads), including 3/6 dyads involving a male index and a younger woman. Index participants with a referred partner were more likely to report no casual partners and to be living with their current partner than participants not in dyads.
CONCLUSIONS


Passive-partner referral successfully identified partners with genetically-similar HIV infections-the likely source of infection-but only 40% of index cases referred partners who presented for HIV-1 testing. Future work evaluating assisted partner notification may help reach susceptible partners or more people with untreated HIV-1 infections connected to acute transmission.
CLINICAL TRIALS REGISTRATION


NCT01450189.",2019,"Age-disparate relationships among dyads were common (≥5-year age difference in 67% of dyads), including 3/6 dyads involving a male index and a younger woman.","['Participants referred sexual partners by passive referral', 'Between 2012 and 2014, 46 persons with AHI in Malawi participated in a', 'AHI participants who referred a single partner that returned for testing', '45 AHI participants with HIV-1 sequences, none was phylogenetically-linked with another AHI index', 'Index participants with a referred partner', 'Age-disparate relationships among dyads were common (≥5-year age difference in 67% of dyads), including 3/6 dyads involving a male index and a younger woman', 'persons with AHI and their referred partners', 'Most partners (n = 17) were HIV-infected, with 15 (88%) presenting with an established infection', 'Human Immunodeficiency Virus (HIV)-1 Transmission', 'Persons With Acute HIV-1 Infection in Malawi']",['combined behavioral and biomedical intervention'],"['Demographics and sexual behaviors', 'HIV-1 phylogenetic and behavioral characteristics', 'AHI index']","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",17.0,0.027083,"Age-disparate relationships among dyads were common (≥5-year age difference in 67% of dyads), including 3/6 dyads involving a male index and a younger woman.","[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Dennis', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Rucinski', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Rutstein', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Powers', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Dana K', 'Initials': 'DK', 'LastName': 'Pasquale', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Phiri', 'Affiliation': 'Lighthouse Trust, University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gift', 'Initials': 'G', 'LastName': 'Kamanga', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Nsona', 'Affiliation': 'Lighthouse Trust, University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Massa', 'Affiliation': 'University of North Carolina Project, Lilongwe, Malawi.'}, {'ForeName': 'Irving F', 'Initials': 'IF', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Audrey E', 'Initials': 'AE', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, Ohio State University, Columbus.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1006']
3054,31254177,Semantic relatedness and distinctive processing may inflate older adults' positive memory bias.,"Emotional stimuli are often more semantically interrelated and relatively distinct than neutral stimuli. These factors can enhance memory for emotional stimuli in young adults, but their effects in older adults-and on the age-related positive memory bias-remain unknown. In the present article, we tested whether item relatedness and distinctiveness affect emotional memory in young adults (Exps. 1 and 2) and the positive memory bias in older adults (Exp. 2). In both experiments, participants studied positive, negative, and neutral pictures and performed free recall after 1 min and 45 min. To manipulate relatedness, the neutral pictures were either as highly interrelated as the emotional pictures (""related neutral"") or lower in semantic relatedness (""unrelated neutral""). To manipulate distinctiveness, we had participants process the emotional pictures in either a relatively distinct manner (mixed condition), by studying emotional and neutral pictures at the same time, or in a nondistinctive manner (unmixed condition), by studying and recalling each picture category separately. Overall, higher semantic relatedness (i.e., related-neutral vs. unrelated-neutral pictures) increased memory in both age groups. Distinctiveness did not affect memory in young adults, but it did alter the positive memory bias in older adults. Older adults recalled more positive than negative pictures when the pictures were processed in mixed sets, but not when they were processed in unmixed sets. These findings were consistent across both test delays. This suggests that previous reports, which were often based on mixed designs in which item interrelatedness was not controlled, may have overestimated the size and/or robustness of the positivity bias in older adults.",2019,"Older adults recalled more positive than negative pictures when the pictures were processed in mixed sets, but not when they were processed in unmixed sets.","['older adults', 'Older adults', 'young adults (Exps. 1 and 2) and the positive memory bias in older adults (Exp. 2', 'young adults']",[],['Emotional stimuli'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0561841', 'cui_str': 'Pleasant memories'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",,0.0428881,"Older adults recalled more positive than negative pictures when the pictures were processed in mixed sets, but not when they were processed in unmixed sets.","[{'ForeName': 'Kylee T', 'Initials': 'KT', 'LastName': 'Ack Baraly', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Morand', 'Affiliation': 'CNRS, LPNC, Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fusca', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Patrick S R', 'Initials': 'PSR', 'LastName': 'Davidson', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hot', 'Affiliation': 'CNRS, LPNC, Université Grenoble Alpes, Grenoble, France. Pascal.Hot@univ-smb.fr.'}]",Memory & cognition,['10.3758/s13421-019-00943-3']
3055,32949123,"Evaluation of Absenteeism, Pain, and Disability in Nurses With Persistent Low Back Pain Following Cognitive Functional Therapy: A Case Series Pilot Study With 3-Year Follow-Up.","OBJECTIVE


Persistent low back pain (PLBP) is a common and costly health problem worldwide. Better strategies to manage it are required. The purpose of this study was to longitudinally evaluate absenteeism, pain, and disability in nurses with PLBP following a cognitive functional therapy (CFT) intervention.
METHODS


In this case-series pilot study, 33 eligible nurses with PLBP were recruited. During the baseline phase A (no intervention) outcome measures were collected on 2 occasions 6 months apart (A1 and A2). During phase B, subjects participated in an individualized CFT intervention for 14 weeks. During phase C (no intervention), outcomes were measured immediately after the intervention, as well as 3, 6, 9, 12 and 36 months after the intervention (secondary outcomes only until 12 months). LBP-related work absenteeism, pain intensity (Numeric Rating Scale) and disability (Oswestry Disability Index) were the primary outcomes. Health care seeking, a range of psychological and lifestyle variables, and global perceived effect were secondary outcomes.
RESULTS


Days of absenteeism due to LBP were significantly reduced in the first and second calendar year after the CFT intervention, but not the third and fourth. Disability was significantly reduced immediately after (-4.4; 95%CI = -6.5 to -2.2) and at 3 months (-4.3; 95%CI = -6.6 to -2.0), 9 months (-6.0; 95%CI = -8.1 to -3.9), and 12 months (-4.9; 95%CI = -7.0 to -2.8) after the intervention. Pain was significantly reduced immediately after (-1.2; 95%CI = -1.7 to -0.8) and at 3 months (-1.5; 95%CI = -2.0 to -0.9), 9 months (-1.1; 95%CI = -1.9 to -0.3) and 12 months (-0.9; 95%CI = -1.5 to -0.2) after the intervention. Total health care seeking (consults and proportion of participants) was significantly reduced after the intervention. All psychosocial variables, except for 1, demonstrated significant improvements at all follow-ups.
CONCLUSIONS


This case-series pilot study demonstrated significant reductions in LBP-related absenteeism, pain intensity, disability, health care seeking, and several psychological and lifestyle behaviors until 1 year follow-up among nurses with PLBP following an individualized CFT intervention. Further evaluation of the efficacy.",2020,"RESULTS


Days of absenteeism due to LBP were significantly reduced in the first and second calendar year after the CFT intervention, but not the third and fourth.","['nurses with PLBP following a', 'Nurses With Persistent Low Back Pain', '33 eligible nurses with PLBP were recruited']","['Cognitive Functional Therapy', 'cognitive functional therapy (CFT) intervention', 'individualized CFT intervention']","['Disability', 'LBP-related work absenteeism, pain intensity (Numeric Rating Scale) and disability (Oswestry Disability Index', 'Total health care seeking', 'Absenteeism, Pain, and Disability', 'Pain', 'absenteeism, pain, and disability', 'absenteeism due to LBP', 'LBP-related absenteeism, pain intensity, disability, health care seeking, and several psychological and lifestyle behaviors']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",33.0,0.105218,"RESULTS


Days of absenteeism due to LBP were significantly reduced in the first and second calendar year after the CFT intervention, but not the third and fourth.","[{'ForeName': 'Wannes', 'Initials': 'W', 'LastName': 'Van Hoof', 'Affiliation': 'Department of Rehabilitation Sciences, Musculoskeletal Research Unit, Faculty of Movement and Rehabilitation Sciences, Katholieke Universiteit Leuven, Tervuursevest 101, B-3001 Leuven, Belgium.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'M Manip Ther, School of Allied Health, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland, and Ageing Research Centre, Health, Research Institute, University of Limerick.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Verschueren', 'Affiliation': 'Department of Rehabilitation Sciences, Musculoskeletal Research Unit, Faculty of Movement and Rehabilitation sciences, Katholieke Universiteit Leuven.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Dankaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Musculoskeletal Research Unit, Faculty of Movement and Rehabilitation sciences, Katholieke Universiteit Leuven.'}]",Physical therapy,['10.1093/ptj/pzaa164']
3056,32944252,A lifestyle intervention during pregnancy to reduce obesity in early childhood: the study protocol of ADEBAR - a randomized controlled trial.,"Background


The prevalence of obesity in childhood is increasing worldwide and may be affected by genetic factors and the lifestyle (exercise, nutrition behavior) of expectant parents. Lifestyle factors affect adipokines, namely leptin, resistin, and adiponectin as well as cytokines such as tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6), which are involved in the regulation of maternal metabolic homeostasis, glucose metabolism, and the development of insulin resistance, metabolic syndrome, gestational diabetes mellitus, and hypertension. However, studies focusing on the effect of exercise or a combination of parental exercise and nutrition on the above-mentioned markers in newborns (venous cord blood) and especially on the long-term development of infants' weight gain are lacking. The study will investigate the effects of a multimodal intervention (regular exercise, diet) on parental and childhood adipocytokines (leptin, resistin, adiponectin, TNF-α, IL-6, BDNF). The effect of a lifestyle-related change in ""fetal environmental conditions"" on the long-term weight development of the child up to the age of two will also be assessed.
Methods/design


A randomized multi-center controlled trial will be conducted in Germany, comparing supervised aerobic and resistance training 2x/week (13th to 36th weeks of gestation) and nutritional counseling (6th to 36th weeks of gestation) during pregnancy with usual care. Thirty women (pre-pregnancy Body Mass Index ≥25 kg/m 2 , 6th-10th week of gestation) will be included in each group. Maternal anthropometric and physical measurements as well as blood sampling will occur at the 6th-10th, 13th-14th, 21st-24th, and 36th week of gestation, at delivery as well as 8 weeks and 24 months postpartum. Neonatal measurements and umbilical blood sampling will be performed at birth. Maternal and infants' weight development will be assessed every 6 months till 24 months postpartum. A difference in childhood BMI of 1 kg/m 2  at the age of two years between both groups will be assumed. A power size of 80% using a significance level of 0.05 and an effect size of 1.0 is presumed.
Discussion


A better understanding of how lifestyle-related changes in the fetal environment might influence infants' outcome after two years of life could have a profound impact on the prevention and development of infants' obesity.
Trial registration


The trial is registered at the German Clinical Trial Register (DRKS00007702); Registered on 10th of August 2016; retrospectively registered https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007702.",2020,"The effect of a lifestyle-related change in ""fetal environmental conditions"" on the long-term weight development of the child up to the age of two will also be assessed.
","['Thirty women', 'early childhood']","['multimodal intervention (regular exercise, diet', 'supervised aerobic and resistance training 2x/week (13th to 36th weeks of gestation) and nutritional counseling', 'lifestyle intervention', 'parental exercise and nutrition']","['Lifestyle factors affect adipokines, namely leptin, resistin, and adiponectin as well as cytokines such as tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6', 'Neonatal measurements and umbilical blood sampling', 'Maternal anthropometric and physical measurements', 'childhood BMI', 'parental and childhood adipocytokines (leptin, resistin, adiponectin, TNF-α, IL-6, BDNF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",,0.135636,"The effect of a lifestyle-related change in ""fetal environmental conditions"" on the long-term weight development of the child up to the age of two will also be assessed.
","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Ferrari', 'Affiliation': 'Cologne Centre for Prevention in Childhood and Youth/ Heart Centre Cologne, University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Schmitz', 'Affiliation': 'Department for physical activity in public health, Institute of Movement and Neurosciences, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Schmidt', 'Affiliation': 'Department for physical activity in public health, Institute of Movement and Neurosciences, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933 Cologne, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Mahabir', 'Affiliation': 'Comparative Medicine, Center for Molecular Medicine, University of Cologne, Robert-Koch-Str. 21, 50931 Cologne, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Van de Vondel', 'Affiliation': 'Hospital Porz, Urbacher Weg 19, 51149 Cologne, Germany.'}, {'ForeName': 'Waltraut M', 'Initials': 'WM', 'LastName': 'Merz', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Bonn Medical School, Sigmund-Freud-Str. 25, 53105 Bonn, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Lehmacher', 'Affiliation': 'Department of Biometry (IMSIE), Faculty of medicine, University of Cologne, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stock', 'Affiliation': 'Cologne Institute for Health Economics and Clinical Epidemiology, The University Hospital of Cologne, Gleueler Strasse 176 - 178/II, 50935 Cologne, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Brockmeier', 'Affiliation': 'Cologne Centre for Prevention in Childhood and Youth/ Heart Centre Cologne, University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Ensenauer', 'Affiliation': ""Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital, University of Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany.""}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Düsseldorf, University of Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Joisten', 'Affiliation': 'Cologne Centre for Prevention in Childhood and Youth/ Heart Centre Cologne, University Hospital of Cologne, Kerpener Str. 62, 50937 Cologne, Germany.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00198-5']
3057,32944254,"Effects of kinesio tape on kinesiophobia, balance and functional performance of athletes with post anterior cruciate ligament reconstruction: a pilot clinical trial.","Background


Anterior cruciate ligament trauma is one of the most common knee injuries in professional athletes. This study aimed to investigate the effects of kinesio taping on kinesiophobia, balance, and functional performance in athletes after anterior cruciate ligament reconstruction.
Methods


This randomized, placebo-controlled clinical trial was performed on 20 athletes with anterior cruciate ligament reconstruction (mean age 32.3 ± 6.2 years) at the time of return to sport. The subjects were randomly assigned to the kinesio tape (KT) group ( n  = 10) or placebo KT group ( n  = 10).While subjects under taped, the following outcomes were measured at baseline, 10 minutes after the intervention, and 2 days later. Kinesiophobia, balance, strength, and functional / agility performance were assessed by the Tampa Scale, Y balance test (YBT), single-leg hops, and 10-yard extremity functional test, respectively.
Results


The results did not show a significant difference between-group post-intervention differences in kinesiophobia (Mean between-group difference = - 6.30, 95% CI = - 4.35 to 1.42,  P -value = 0.17). Likewise, no significant statistical difference was observed between two study groups in terms of YBT scores (Mean between-group difference ranged over = - 6.30, 95% CI = - 1.1 to 4.7, the effect sizes ranged over = 0.01 to 0.31),  P -value > 0.05), Single Leg Hop (Mean between-group difference = - 0.48, 95% CI for difference ranged over = - 10.3 to 9.3, effect size = 0.001,  P -value = 0.918), and 10 Yard test scores (Mean between-group difference = - 0.30, 95% CI = (- 1.3 to 0.75), effect size = 0.02,  P -value = 0.55) at 2 days after the KT. In the KT and placebo KT groups, RMANOVA indicated that the differences in all variables scores were significant over time with large effect sizes (effect size ranged over = 0.94-0.99; all  P -value < 0.001).
Conclusion


This study gives no support for any beneficial effect of kinesio taping on the reduction of kinesiophobi or improvement of balance score and functional performance in athletes with post anterior cruciate ligament reconstruction.
Trial registration


This study was registered in the Iranian Clinical Trial Center with the code IRCT20190130042556N1, registered 12 February 2019.",2020,"This study gives no support for any beneficial effect of kinesio taping on the reduction of kinesiophobi or improvement of balance score and functional performance in athletes with post anterior cruciate ligament reconstruction.
","['professional athletes', 'athletes with post anterior cruciate ligament reconstruction', 'Iranian Clinical Trial Center with the code IRCT20190130042556N1, registered 12 February 2019', 'athletes after anterior cruciate ligament reconstruction', '20 athletes with anterior cruciate ligament reconstruction (mean age 32.3\u2009±\u20096.2\u2009years) at the time of return to sport']","['placebo KT', 'placebo', 'kinesio tape (KT', 'kinesio taping', 'kinesio tape']","['balance score and functional performance', 'Kinesiophobia, balance, strength, and functional / agility performance', 'kinesiophobia', 'Single Leg Hop', 'YBT scores', 'kinesiophobia, balance, and functional performance', 'Tampa Scale, Y balance test (YBT), single-leg hops, and 10-yard extremity functional test, respectively', 'kinesiophobia, balance and functional performance']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439205', 'cui_str': 'yd'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",20.0,0.163481,"This study gives no support for any beneficial effect of kinesio taping on the reduction of kinesiophobi or improvement of balance score and functional performance in athletes with post anterior cruciate ligament reconstruction.
","[{'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Kamali', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirzeai', 'Affiliation': 'School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motealleh', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'MohammadBagher', 'Initials': 'M', 'LastName': 'Shamsi', 'Affiliation': 'School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00203-x']
3058,32944265,Effect of milk fat-based infant formulae on stool fatty acid soaps and calcium excretion in healthy term infants: two double-blind randomised cross-over trials.,"Background


Palmitic acid (PA) is predominantly esterified at the SN-2 position of triacylglycerols in human milk. PA at the SN-2 position is more efficiently absorbed and results in reduced formation of PA soaps, as well as reduced fatty acid (FA) and calcium malabsorption. Bovine milk fat (MF), a natural source of SN-2-palmitate, was used in the fat blend of infant formulae (IF) in the current study to investigate its effect on stool fatty acid soaps, calcium excretion and stool characteristics.
Methods


Two double-blind, randomised cross-over trials (CS1, CS2) were conducted in parallel with healthy term, formula-fed infants aged 9-14 weeks. After a two-week run-in period, infants in CS1 ( n  = 17) were randomly allocated to receive either a 50% MF-based formula (50MF) or a 100% vegetable fat (VF) formula; in CS2 ( n  = 18), infants received either a 20% MF-based formula (20MF) or the VF formula, in a 2 × 2-week cross-over design. At the end of each two-week intervention period, stool samples were collected for FA, FA soaps and calcium excretion analysis and stool consistency was assessed according to the Amsterdam Infant Stool Scale (AISS).
Results


MF-based groups showed no significant difference in PA in stools compared to VF group, although reduced stool PA soaps (CS1: 111.28 ± 18.33 vs. 220.25 ± 29.35 mg/g dry weight,  p  < 0.0001; CS2: 216.24 ± 25.16 vs. 233.94 ± 35.12 mg/g dry weight,  p  = 0.0023), total FA soaps and calcium excretion (CS1: 46.40 ± 5.27 vs. 49.88 ± 4.77 mg/g dry weight,  p  = 0.0041; CS2: 46.20 ± 4.26 vs. 50.47 ± 6.71 mg/g dry weight,  p  = 0.0067) were observed. Furthermore, the 50MF group showed a favourable lower mean stool consistency score compared to the VF group (1.64 ± 0.49 vs. 2.03 ± 0.19,  p  = 0.0008).
Conclusions


While the use of bovine MF in IF did not affect PA concentrations in stool, lower excretion of palmitate soaps, total FA soaps and calcium was seen in healthy term infants. 50MF formula also showed improved stool consistency. The use of MF in IF could be an interesting approach to improve gut comfort and stool characteristics in infants, warranting further research.
Trial registration


Netherlands Trial Registry Identifier: NTR6702. Date registered: December 01, 2017.",2020,"Results


MF-based groups showed no significant difference in PA in stools compared to VF group, although reduced stool PA soaps (CS1: 111.28 ± 18.33 vs. 220.25 ± 29.35 mg/g dry weight,  p  < 0.0001; CS2: 216.24 ± 25.16 vs. 233.94 ± 35.12 mg/g dry weight,  p  = 0.0023), total FA soaps and calcium excretion (CS1: 46.40 ± 5.27 vs. 49.88 ± 4.77 mg/g dry weight,  p  = 0.0041; CS2: 46.20 ± 4.26 vs. 50.47 ± 6.71 mg/g dry weight,  p  = 0.0067) were observed.","['infants in CS1 ( n \u2009=\u200917', 'parallel with healthy term, formula-fed infants aged 9-14\u2009weeks', 'healthy term infants']","['50% MF-based formula (50MF) or a 100% vegetable fat (VF) formula; in CS2', '20% MF-based formula (20MF) or the VF formula', 'milk fat-based infant formulae', 'Bovine milk fat (MF', '\n\n\nPalmitic acid (PA']","['reduced fatty acid (FA) and calcium malabsorption', 'Amsterdam Infant Stool Scale (AISS', 'mean stool consistency score', 'stool fatty acid soaps, calcium excretion and stool characteristics', 'total FA soaps and calcium', 'total FA soaps and calcium excretion', 'stool consistency', 'FA, FA soaps and calcium excretion analysis and stool consistency', 'PA in stools', 'stool fatty acid soaps and calcium excretion', 'reduced stool PA soaps']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038238', 'cui_str': 'Fatty stool'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}]",,0.168955,"Results


MF-based groups showed no significant difference in PA in stools compared to VF group, although reduced stool PA soaps (CS1: 111.28 ± 18.33 vs. 220.25 ± 29.35 mg/g dry weight,  p  < 0.0001; CS2: 216.24 ± 25.16 vs. 233.94 ± 35.12 mg/g dry weight,  p  = 0.0023), total FA soaps and calcium excretion (CS1: 46.40 ± 5.27 vs. 49.88 ± 4.77 mg/g dry weight,  p  = 0.0041; CS2: 46.20 ± 4.26 vs. 50.47 ± 6.71 mg/g dry weight,  p  = 0.0067) were observed.","[{'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Karaglani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Thijs-Verhoeven', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, the Netherlands.'}, {'ForeName': 'Elpis', 'Initials': 'E', 'LastName': 'Vlachopapadopoulou', 'Affiliation': ""Department of Endocrinology-Growth and Development, Children's Hospital P. & A. Kyriakou, Athens, Greece.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Papazoglou', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Maragoudaki', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Zafeiris', 'Initials': 'Z', 'LastName': 'Manikas', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Tarek-Michail', 'Initials': 'TM', 'LastName': 'Kampani', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Iliana', 'Initials': 'I', 'LastName': 'Christaki', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece.'}, {'ForeName': 'Marlotte M', 'Initials': 'MM', 'LastName': 'Vonk', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, the Netherlands.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bos', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, the Netherlands.'}, {'ForeName': 'Panam', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'FrieslandCampina, Stationsplein 1, 3818 LE Amersfoort, the Netherlands.'}]",BMC nutrition,['10.1186/s40795-020-00365-4']
3059,32944504,Treating perfectionism using internet-based cognitive behavior therapy: A study protocol for a randomized controlled trial comparing two types of treatment.,"Perfectionism is characterized by setting high standards and striving for achievement, sometimes at the expense of social relationships and wellbeing. Despite sometimes being viewed as a positive feature by others, people with perfectionism tend to be overly concerned about their performance and how they are being perceived by people around them. This tends to create inflexible standards, cognitive biases, and performance-related behaviors that maintain a belief that self-worth is linked to accomplishments. Cognitive behavior therapy has been shown to be a viable treatment for perfectionism, both in terms of reducing levels of perfectionism and improving psychiatric symptoms. Furthermore, a number of recent studies indicate that it can be successfully delivered via the Internet, both with regular support and guidance on demand from a therapist. In the present study protocol, a clinical trial for perfectionism is described and outlined. In total, 128 participants will be recruited and randomized to either a treatment that has already been demonstrated to have many benefits, Internet-based Cognitive Behavior Therapy for perfectionism (iCBT-P), or an active comparison condition, Internet-based Unified Protocol (iUP), targeting the emotions underlying depression and anxiety disorders. The results will be investigated with regard to self-reported outcomes of perfectionism, psychiatric symptoms, self-compassion, and quality of life, at post-treatment and at six- and 12-month follow-up. Both iCBT-P and iUP are expected to have a positive impact, but the difference between the two conditions in terms of their specific effects and adherence are currently unknown and will be explored. The clinical trial is believed to lead to a better understanding of how perfectionism can be treated and the specificity of different treatments.",2020,"Cognitive behavior therapy has been shown to be a viable treatment for perfectionism, both in terms of reducing levels of perfectionism and improving psychiatric symptoms.",['128 participants'],"['Cognitive behavior therapy', 'internet-based cognitive behavior therapy', 'Internet-based Cognitive Behavior Therapy for perfectionism (iCBT-P), or an active comparison condition, Internet-based Unified Protocol (iUP']","['perfectionism, psychiatric symptoms, self-compassion, and quality of life']",[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",128.0,0.0767132,"Cognitive behavior therapy has been shown to be a viable treatment for perfectionism, both in terms of reducing levels of perfectionism and improving psychiatric symptoms.","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Buhrman', 'Affiliation': 'Department of Psychology, Uppsala University, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Gelberg', 'Affiliation': 'Department of Psychology, Uppsala University, Sweden.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Jovicic', 'Affiliation': 'Department of Psychology, Uppsala University, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Molin', 'Affiliation': 'Department of Psychology, Uppsala University, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Forsström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Sweden.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rozental', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Sweden.'}]",Internet interventions,['10.1016/j.invent.2020.100338']
3060,32944505,An iPad application-based intervention for improving post-stroke depression symptoms in a convalescent rehabilitation ward: A pilot randomized controlled clinical trial protocol.,"Background


Post-stroke depression (PSD) is a neuropsychiatric sequela that causes serious adverse effects on the prognosis of stroke patients. Our developed iPad application is a very innovative approach designed to improve participants' depressive symptoms by presenting positive words stimuli in a video. Although this application has fewer side effects than existing pharmacological and non-pharmacological interventions and is likely less burdensome for patients and caregivers, its efficacy for PSD has not been investigated. Here we present a pilot randomized controlled trial (RCT) protocol to investigate the therapeutic potential of this application intervention for PSD patients.
Methods


This study is designed as a 5-week, single-center, open-label, parallel-group, pilot RCT. Thirty-two patients with PSD will be randomly assigned to a combination of the iPad application and usual rehabilitation or usual rehabilitation alone (1:1 allocation ratio). The iPad application intervention lasts 3 min a day, and the usual rehabilitation lasts 3 h a day. The primary outcome is the change from baseline in The Center for Epidemiologic Studies Depression Scale score at the end of the 5-week intervention.
Discussion


This pilot RCT is the first study to investigate the potential of iPad application interventions to reduce depressive symptoms in PSD patients. This pilot RCT determines whether this is a viable and effective intervention and informs the design for a full-scale trial. If our hypothesis is correct, this trial can provide evidence to augment the standard practice of iPad application interventions to improve depressive symptoms in patients with PSD.",2020,Our developed iPad application is a very innovative approach designed to improve participants' depressive symptoms by presenting positive words stimuli in a video.,"['PSD patients', 'Thirty-two patients with PSD', 'patients with PSD', 'post-stroke depression symptoms in a convalescent rehabilitation ward']","['iPad application-based intervention', 'iPad application and usual rehabilitation or usual rehabilitation alone (1:1 allocation ratio']","['depressive symptoms', 'change from baseline in The Center for Epidemiologic Studies Depression Scale score']","[{'cui': 'C2938940', 'cui_str': 'Post stroke depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",32.0,0.108485,Our developed iPad application is a very innovative approach designed to improve participants' depressive symptoms by presenting positive words stimuli in a video.,"[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Hiragaki', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Nishi', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Shiori', 'Initials': 'S', 'LastName': 'Nakahara', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Koumoto', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Onmyoji', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Kazuho', 'Initials': 'K', 'LastName': 'Kawakami', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ishii', 'Affiliation': 'Department of Rehabilitation, Kurashiki Heisei Hospital, Kurashiki, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Graduate School of Health Sciences, Gunma University, Maebashi, Japan.'}]",Internet interventions,['10.1016/j.invent.2020.100340']
3061,32944518,Effect of penile rehabilitation with low intensity extracorporeal shock wave therapy on erectile function recovery following robot-assisted laparoscopic prostatectomy.,"Backgrounds


Considering the natural course of cavernous nerve recovery after robot-assisted laparoscopic prostatectomy (RALP), early intervention of low intensity extracorporeal shock wave therapy (LIESWT) would be more effective for enhancing overall recovery of sexual function (SF). Our objective of this study is to analyze longitudinally the alterations of SF in patients after RALP, with a focus on the effect of early and delayed intervention with LIESWT.
Methods


A total of 5 and 11 patients underwent early and delayed intervention with LIESWT, respectively. SF was assessed with the Expanded Prostate Cancer Index Composite (EPIC). The same surgeon performed RALP on 178 patients, and these patients were assigned to the non-LIESWT group to establish a control group. The SF score of EPIC was investigated longitudinally before RALP and 3, 6, 9, and 12 months after RALP.
Results


Our results show that penile rehabilitation with LIESWT immediately before urethral catheter removal improved SF scores. In the baseline, the SF score was significantly higher in the early LIESWT group (P=0.0001). The SF score was significantly lower at postoperative 6 months (early 19.2, delayed 17.9, and non-LIESWT 8.1; P=0.0171), 9 months (20.9, 25.8, and 10.2; P=0.0188), and 12 months (28.0, 21.3, and 9.5; P=0.0051) in the non-LIESWT group. We regret that there was no significant difference in the recovery of SF between the early and delayed protocol with LIESWT at all points. In keeping with our results, LIESWT demonstrated the potential to be efficacious in treatment options for severe post-radical prostatectomy (RP) erectile dysfunction (ED) as it may indirectly support its promotion of nerve regeneration in severe ED due to RP.
Conclusions


This is the first study in which LIESWT has been shown to deliver a clinical benefit on its early or delayed intervention to patients after RALP to penile rehabilitation in terms of restoring SF. Our preliminary results suggest that LIESWT could be used as a treatment option in penile rehabilitation.",2020,"In the baseline, the SF score was significantly higher in the early LIESWT group (P=0.0001).",[],"['robot-assisted laparoscopic prostatectomy', 'LIESWT', 'robot-assisted laparoscopic prostatectomy (RALP), early intervention of low intensity extracorporeal shock wave therapy (LIESWT', 'penile rehabilitation with low intensity extracorporeal shock wave therapy']","['Expanded Prostate Cancer Index Composite (EPIC', 'SF scores', 'recovery of SF', 'SF score', 'erectile function recovery', 'SF score of EPIC']",[],"[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",178.0,0.0323181,"In the baseline, the SF score was significantly higher in the early LIESWT group (P=0.0001).","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Tetsutaro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Teishima', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Matsubara', 'Affiliation': 'Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",Translational andrology and urology,['10.21037/tau-19-888']
3062,32944554,Nitroglycerin Plus Morphine on Iv Patient Controlled Analgesia for Abdominal Surgery: The Effect on Postoperative Pain.,"Background


Some studies have reported the effect of nitroglycerin on the reduction of pain after surgery.
Objectives


The primary goal of the current study was to evaluate the addition of nitroglycerin (as a nitric oxide donor) to morphine in patient-controlled analgesia. Besides, its effects on the reduction of pain and stability in hemodynamic indices after abdominal surgery are also investigated.
Methods


The current study was performed on 60 patients as candidates for abdominal surgery. Morphine (0.75 mg/mL) and nitroglycerin plus morphine (morphine 0.5 mg/mL + TNG 15 μg/mL) infusions were used for control and case groups, respectively, with the same induction of anesthesia. The severity of postoperative pain, hemodynamic indices of systolic blood pressure, diastolic pressure, heart rate, respiratory rate, and nausea were measured after surgery (immediately, 2, 6, 12, and 24 hours after surgery).
Results


The pain score decreased for both groups almost similarly. The mean systolic blood pressure was highly reduced in both groups. However, the mean diastolic blood pressure in the control group was considerably lower than that of the case group. Besides, the respiratory rate in the case group dramatically diminished and approached the normal value.
Conclusions


Combined administration of nitroglycerin and morphine had no synergistic effects on reducing postoperative pain. However, it led to more stable hemodynamic indices and improved breathing, without any side effects.",2020,The mean systolic blood pressure was highly reduced in both groups.,"['patient-controlled analgesia', '60 patients as candidates for abdominal surgery', 'Abdominal Surgery']","['Nitroglycerin Plus Morphine', 'nitroglycerin', 'Morphine', 'nitroglycerin and morphine', 'nitroglycerin plus morphine (morphine 0.5 mg/mL', 'morphine']","['respiratory rate', 'pain and stability in hemodynamic indices', 'mean systolic blood pressure', 'severity of postoperative pain, hemodynamic indices of systolic blood pressure, diastolic pressure, heart rate, respiratory rate, and nausea', 'Postoperative Pain', 'pain score', 'postoperative pain', 'mean diastolic blood pressure']","[{'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.0370519,The mean systolic blood pressure was highly reduced in both groups.,"[{'ForeName': 'Seyyed Hasan', 'Initials': 'SH', 'LastName': 'Karbasy', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Sekhavati', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sabertanha', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}, {'ForeName': 'BibiFatemeh', 'Initials': 'B', 'LastName': 'Shakhsemampour', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Birjand University of Medical Sciences, Birjand, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.99582']
3063,32944555,The Comparison of Direct Laryngoscopy and Video Laryngoscopy in Pediatric Airways Management for Congenital Heart Surgery: A Randomized Clinical Trial.,"Background


Airway management in patients with hereditary heart disease is an important therapeutic intervention.
Objectives


The purpose of this study was to compare direct laryngoscopy (DL) with video laryngoscopy (VL) in pediatric airways management for congenital heart surgery.
Methods


This study was designed as a prospective randomized clinical trial. Two consecutive groups of 30 patients undergoing elective noncyanotic congenital heart surgery. The patients were divided into direct laryngoscopy versus video laryngoscopy for intubation of the trachea. The main outcomes were the number of success rate in the first attempt, and the secondary outcomes were the duration of successful intubation and complications, such as desaturation and bradycardia.
Results


Intubation procedure time was measured as 51.13 ± 17.88 seconds for the group with direct laryngoscopy and 59.66 ± 45.91 seconds for group with VL that was significant (P = 0.006). In DL group, 22 patients were intubated on the first attempt, 8 patients on the second attempt, and 6 patients on the third attempt, compared to 24, 6, and 2 respectively, in VL group. The differences were significant only in the third attempt between groups (P = 0.033). The important difference established in heart rate (HR) and SpaO 2  amounts between the two groups at any time (P < 0.05).
Conclusions


VL can produce better visualization for intubation of trachea in congenital heart disease, but this is time-consuming. Indeed, training in the use of the VL should be increased to reduce the time required for performance. Moreover, further studies are recommended to approve these helpful findings.",2020,"Results


Intubation procedure time was measured as 51.13 ± 17.88 seconds for the group with direct laryngoscopy and 59.66 ± 45.91 seconds for group with VL that was significant (P = 0.006).","['patients with hereditary heart disease', '30 patients undergoing elective noncyanotic congenital heart surgery', 'Congenital Heart Surgery', 'pediatric airways management for congenital heart surgery']","['Direct Laryngoscopy and Video Laryngoscopy', 'direct laryngoscopy versus video laryngoscopy', 'direct laryngoscopy (DL) with video laryngoscopy (VL']","['duration of successful intubation and complications, such as desaturation and bradycardia', 'heart rate (HR) and SpaO 2  amounts', 'number of success rate', 'Intubation procedure time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}]","[{'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",30.0,0.0357018,"Results


Intubation procedure time was measured as 51.13 ± 17.88 seconds for the group with direct laryngoscopy and 59.66 ± 45.91 seconds for group with VL that was significant (P = 0.006).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforooshzadeh', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Gharacheh', 'Affiliation': 'Student Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.99827']
3064,32944556,"Comparison of Intrathecal Injection of Fentanyl and Sufentanil on the Onset, Duration, and Quality of Analgesia in Labor: A Randomized, Double-Blind Clinical Trial.","Background


Labor pain is a severe pain, and intrathecal opioid injection is one of the analgesia methods to reduce it.
Objectives


We assessed the effects of intrathecal Fentanyl and Sufentanil on the onset, duration, and quality of analgesia for labor analgesia.
Methods


In this double-blind, randomized clinical trial, 54 healthy nulliparous women 18 - 45 years in the active phase of labor who were requesting labor analgesia were enrolled in two groups fentanyl (F) and sufentanil (S). Patients received 75 µg fentanyl or 7.5 µg sufentanil intrathecally in the fentanyl group (n = 27) and the sufentanil group (n = 27), respectively. Pain relief, onset, duration of analgesia, hemodynamic parameters, patients' satisfaction, and neonatal Apgar score were assessed in this study. Data were analyzed by using SPSS16.
Results


There were no significant differences between the groups in terms of demographic and hemodynamic parameters. The onset time of analgesia was 5.6 ± 4.3 and 3.6 ± 2.1 minutes, in the sufentanil and fentanyl groups, respectively (P = 0.037). The duration of analgesia was higher in patients who received sufentanil than those who received fentanyl (113 ± 45 vs. 103 ± 22 minutes (P = 0.629)). The pain score in the Fentanyl group was significantly lower at 5, 10, and 15 minutes after spinal analgesia (P < 0.05). The sedation score at 1 and 5 minutes was significantly higher in the fentanyl group than the sufentanil group (P < 0.05). The frequency and severity of pruritus and satisfaction rate in the fentanyl group were significantly higher than the sufentanil group.
Conclusions


Intrathecal fentanyl and sufentanil have a similar analgesic effect on labor. Fentanyl is associated with a faster onset of analgesia and more satisfaction, while sufentanil has longer analgesia.",2020,The sedation score at 1 and 5 minutes was significantly higher in the fentanyl group than the sufentanil group (P < 0.05).,"['Labor', '54 healthy nulliparous women 18 - 45 years in the active phase of labor who were requesting labor analgesia were enrolled in two groups']","['sufentanil', 'fentanyl (F) and sufentanil (S', 'fentanyl', 'intrathecal Fentanyl and Sufentanil', '75 µg fentanyl or 7.5 µg sufentanil intrathecally in the fentanyl', 'Fentanyl and Sufentanil', 'Fentanyl']","[""Pain relief, onset, duration of analgesia, hemodynamic parameters, patients' satisfaction, and neonatal Apgar score"", 'onset time of analgesia', 'demographic and hemodynamic parameters', 'duration of analgesia', 'frequency and severity of pruritus and satisfaction rate', 'Onset, Duration, and Quality of Analgesia', 'sedation score', 'pain score', 'onset, duration, and quality of analgesia']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",54.0,0.247393,The sedation score at 1 and 5 minutes was significantly higher in the fentanyl group than the sufentanil group (P < 0.05).,"[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Manouchehrian', 'Affiliation': 'Department of Anesthesiology, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Soghra', 'Initials': 'S', 'LastName': 'Rabiei', 'Affiliation': 'Department of Obstetrics and Gynecology, Fatemi Medical Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Moradi', 'Affiliation': 'Medical Sciences Faculty, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Lakpur', 'Affiliation': 'Medical Sciences Faculty, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.99843']
3065,32944557,Dexmedetomidine as an Additive to Local Anesthesia for Decreasing Intraocular Pressure in Glaucoma Surgery: A Randomized Trial.,"Background


Nowadays, the peribulbar block is used as a tool in glaucoma surgery. As a side effect, it increases intraocular pressure that raises the need for adjuvant medication to overcome this problem in the diseased eye. Dexmedetomidine has proven to decrease intraocular pressure (IOP) in the non-glaucomatous eye.
Objectives


In a triple-blinded randomized study, dexmedetomidine as an adjuvant to the peribulbar block was used to decrease IOP in the diseased eye.
Methods


We randomized 98 eyes to three groups, including D50 (35 eyes) with dexmedetomidine 50 µg, D25 (33 eyes) with dexmedetomidine 25 µg, or control group (C) (30 eyes) with the plain peribulbar block. The study was randomized triple-blinded, aiming at testing the effect of dexmedetomidine on IOP after block injection.
Results


The pre-injection IOP was 27.71 ± 2.52, 27.25 ± 3.53, and 26.2 ± 3.57 mmHg in groups D50, D25, and C, respectively, then increased to 29.71 ± 1.69, 30.25 ± 2.36 and 29.4 ± 3.756 in groups D50, D25 and C, respectively, with P >0.05. The pressure decreased after the surgery to 10.86 ± 1.478 in group D50, 10.75 ± 1.63 in group D25, and 10.6 ± 1.589 in group C, with no statistical differences (P > 0.05) between the groups.
Conclusions


Dexmedetomidine did not decrease IOP in the glaucomatous eye.",2020,"The pressure decreased after the surgery to 10.86 ± 1.478 in group D50, 10.75 ± 1.63 in group D25, and 10.6 ± 1.589 in group C, with no statistical differences (P > 0.05) between the groups.
","['Glaucoma Surgery', '50 µg, D25 (33 eyes) with', '98 eyes to three groups, including D50 (35 eyes) with']","['Dexmedetomidine', 'dexmedetomidine 25 µg, or control group (C) (30 eyes) with the plain peribulbar block', 'dexmedetomidine']","['IOP', 'intraocular pressure (IOP', 'pressure', 'intraocular pressure']","[{'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0583006', 'cui_str': 'Peribulbar infiltration of local anesthetic'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",98.0,0.286571,"The pressure decreased after the surgery to 10.86 ± 1.478 in group D50, 10.75 ± 1.63 in group D25, and 10.6 ± 1.589 in group C, with no statistical differences (P > 0.05) between the groups.
","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Anesthesia Department, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Eissa', 'Affiliation': 'Ophthalmology Department, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Magdy', 'Affiliation': 'Ophthalmology Department, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Khashba', 'Affiliation': 'Anesthesia Department, Research Institute of Ophthalmology, Cairo, Egypt.'}]",Anesthesiology and pain medicine,['10.5812/aapm.100673']
3066,32944558,Effect of Benson's Relaxation Technique on Propofol Consumption and Preoperative Anxiety of Patients Undergoing Cataract Surgery.,"Background


Benson's relaxation (BR) technique is a suitable non-pharmacological approach to reduce preoperative anxiety (PA).
Objectives


This study aimed to investigate the effect of BR therapy on PA and the induction and maintenance dose of propofol during cataract surgery (CS).
Methods


Seventy-two patients were randomly divided into two experiments or BR and control groups. The Amsterdam and Spielberger State-Trait Anxiety inventory (STAI) scores were used to assess PA directly two days and a half-hour before the CS. The control group did not receive any preoperation intervention or relaxation. Benson's relaxation method was performed three times, each time for 20 minutes, including two days before surgery, a night before surgery, and an hour before the surgery in the presence of a researcher by an audio file. The induction and maintenance dose of anesthetic drug was recorded and compared between the two groups.
Results


The mean propofol consumption was significantly reduced during the induction of anesthesia in the intervention group compared to the control group (0.99 ± 0.29 versus 1.29 ± 0.49; P = 0.005) as well as the maintenance of anesthesia (84.66 ± 17.98 versus 108.33 ± 34.38, P = 0.001). The results of the post-intervention Amsterdam anxiety score showed a significant decrease in the intervention group compared to the control group (P = 0.032, F = 9.61, Eta2 = 0.12). The control group showed a higher Spielberger state score compared to the intervention group as well as the Spielberger trait (P < 0.001, F = 14.78, Eta2 = 0.18).
Conclusions


The BR method effectively reduces the level of PA in patients undergoing CS. Moreover, it reduces the need for anesthetic drug, propofol, during surgery.",2020,"The results of the post-intervention Amsterdam anxiety score showed a significant decrease in the intervention group compared to the control group (P = 0.032, F = 9.61, Eta2 = 0.12).","['Methods\n\n\nSeventy-two patients', 'Patients Undergoing Cataract Surgery', 'patients undergoing CS']","[""Benson's Relaxation Technique"", 'propofol', 'BR therapy', 'control group did not receive any preoperation intervention or relaxation', ""\n\n\nBenson's relaxation (BR) technique""]","['Amsterdam and Spielberger State-Trait Anxiety inventory (STAI) scores', 'anxiety score', 'level of PA', 'mean propofol consumption', 'Propofol Consumption and Preoperative Anxiety', 'Spielberger state score']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0035029', 'cui_str': 'Relaxation technique'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1301808', 'cui_str': 'State'}]",72.0,0.0201459,"The results of the post-intervention Amsterdam anxiety score showed a significant decrease in the intervention group compared to the control group (P = 0.032, F = 9.61, Eta2 = 0.12).","[{'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barabady', 'Affiliation': 'Department of Psychology, Tehran Markaz Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Baghdassarians', 'Affiliation': 'Department of Psychology, Tehran Markaz Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Memary', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Yazdani', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Barabady', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Sayadi', 'Affiliation': 'Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.100703']
3067,32944559,"Comparison of the Effect of Bicarbonate, Hyaluronidase, and Lidocaine Injection on Myofascial Pain Syndrome.","Background


Myofascial pain syndrome is a chronic syndrome that occurred in a local or focal part of the body. The basis for myofascial pain syndrome is the presence of myofascial trigger point or points, producing pain in clinical examinations.
Objectives


This study aimed to compare the effect of injection of bicarbonate, hyaluronidase, and lidocaine on myofascial pain syndrome.
Methods


The patients were randomly allocated to three groups of bicarbonate, hyaluronidase, and lidocaine. The injection was done at two painful regions of trapezius muscle with a sonography guide for each patient. The values of visual analogue scale (VAS), pre-injection range of motion (ROM), immediately after injection, second and fourth week were measured.
Results


The analysis showed that there were no significant differences between the three groups for age, gender, BMI, and height (P > 0.05). Repeated measures one-way ANOVA (week * group) 4 * 3 was used to compare the effect of bicarbonate, hyaluronidase, and lidocaine on VAS and range of motion (ROM) before injection, immediately after injection, second and fourth week. The results showed that the main effect of group and week is significant for VAS (P < 0.05). This study showed that the values of VAS were significantly different between the three groups during the fourth weeks of the study. Moreover, the patients experienced more pain decline in the hyaluronidase group during weeks before injection, after injection, second and fourth week, which indicated the permanent effect of this medication on pain decline.
Conclusions


Injection of lidocaine leads to a significant reduction in pain immediately after injection; however, the decline was not permanent and disappeared in the following four weeks. But VAS reduction in hyaluronidase group more than bicarbonate and lidocaine groups.",2020,"The analysis showed that there were no significant differences between the three groups for age, gender, BMI, and height (P > 0.05).",['Myofascial Pain Syndrome'],"['bicarbonate, hyaluronidase, and lidocaine', 'lidocaine', 'Bicarbonate, Hyaluronidase, and Lidocaine Injection', 'bicarbonate']","['values of VAS', 'VAS', 'pain decline', 'VAS reduction', 'VAS and range of motion (ROM', 'values of visual analogue scale (VAS), pre-injection range of motion (ROM', 'pain']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.0277958,"The analysis showed that there were no significant differences between the three groups for age, gender, BMI, and height (P > 0.05).","[{'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Ghasemi', 'Affiliation': 'Anesthesiology Research Center, Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Mosaffa', 'Affiliation': 'Department of Anesthesiology, Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Hoseini', 'Affiliation': 'Anesthesiology Research Center, Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Faranak', 'Initials': 'F', 'LastName': 'Behnaz', 'Affiliation': 'Department of Anesthesiology, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.101037']
3068,32944560,Four-Week Pain Profile and Patient Non-Adherence to Pharmacological Pain Therapy After Day Surgery.,"Background


Nowadays, complicated and painful surgical procedures are encouraged to be carried out in an ambulatory setting.
Objectives


The current study aimed to assess 4-week postoperative pain profiles of 4 painful ambulatory surgical procedures. We analyzed the prevalence of and reasons for non-adherence and partial adherence of patients to a predefined treatment schedule after the ambulant surgery.
Methods


The current study analyzed data from a large randomized trial by evaluating the effect of postoperative pain medication on acute postoperative pain at home during the first 4 postoperative days (POD) in patients scheduled for ambulatory hemorrhoid surgery, shoulder or knee arthroscopy, and inguinal hernia repair. Postoperative pain intensity was assessed at POD 0, 1, 2, 3, 4, 7, 14, and 28 via the Numeric Rating Scale (NRS). Adherence was assessed on POD 1, 2, 3, and 4.
Results


Median average pain scores were above an NRS of 3 during the first postoperative week after shoulder arthroscopy and even above 4 during the first postoperative week after hemorrhoid surgery. 26% of patients undergoing shoulder arthroscopy and hemorrhoid surgery still had moderate pain 1 week after surgery. Median average pain scores were below an NRS of 3 during the whole study period after inguinal hernia repair and knee arthroscopy. 24.61% of patients did not use the study medication as prescribed, 5.76% of whom were non-adherent, and 18.85% were partially adherent.
Conclusions


Each type of ambulant surgery has its unique postoperative pain profile. New strategies should be developed for pain therapy at home, particularly after the ambulatory arthroscopic shoulder surgery and hemorrhoid surgery. Non-adherence is uncommon if they are provided with a multimodal analgesic home kit together with clear verbal, written instructions, and intensive follow-up.",2020,Median average pain scores were below an NRS of 3 during the whole study period after inguinal hernia repair and knee arthroscopy.,"['4 painful ambulatory surgical procedures', 'patients scheduled for ambulatory hemorrhoid surgery, shoulder or knee arthroscopy, and inguinal hernia repair']","['postoperative pain medication', 'shoulder arthroscopy and hemorrhoid surgery', 'Pharmacological Pain Therapy']","['Adherence', 'Numeric Rating Scale (NRS', 'moderate pain', 'Postoperative pain intensity', 'Median average pain scores']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0690096,Median average pain scores were below an NRS of 3 during the whole study period after inguinal hernia repair and knee arthroscopy.,"[{'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Callebaut', 'Affiliation': 'Department of Anesthesiology and Pain, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Steffe', 'Initials': 'S', 'LastName': 'Jorissen', 'Affiliation': 'Department of Anesthesiology and Pain, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pelckmans', 'Affiliation': 'Department of Anesthesiology and Pain, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Berends', 'Affiliation': 'Department of Anesthesiology and Pain, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Droogmans', 'Affiliation': 'Pharmacy, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'van Rossum', 'Affiliation': 'Department of Anesthesiology and Pain, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Nulens', 'Affiliation': 'Department of Anesthesiology and Pain, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Stessel', 'Affiliation': 'Department of Anesthesiology and Pain, Jessa Hospital, Hasselt, Belgium.'}]",Anesthesiology and pain medicine,['10.5812/aapm.101669']
3069,32944562,"Efficacy of Serratus Anterior Plane Block Using Bupivacaine/ Magnesium Sulfate Versus Bupivacaine/ Nalbuphine for Mastectomy: A Randomized, Double-Blinded Comparative Study.","Background


Mastectomy is a common surgical procedure associated with intra and postoperative pain if untreated adequately will lead to chronic pain.
Objectives


This study aimed to evaluate the efficacy of serratus anterior plane block using bupivacaine/magnesium sulfate versus bupivacaine/ nalbuphine for mastectomy.
Methods


40 ASA I and II female patients age 25 - 60 years underwent breast cancer surgery received the block before induction of general anesthesia were divided into two groups GBM (n = 20): (bupivacaine/magnesium sulphate): received bupivacaine 30 mL 0.25% and 500 mg magnesium sulphate, GBN (n = 20): (bupivacaine/nalbuphine): received bupivacaine 30 mL 0.25% and nalbuphine 0.2 mg/kg. The following parameters were recorded: The sensory block, motor block, postoperative heart rate, noninvasive mean blood pressure: at 1, 6, 12, 24 h, postoperative time to first request of analgesics (hours), VAS at rest and movement at 1, 6, 12, 24 h, postoperative analgesic requirements (pethidine mg/24 h).
Results


The sensory block was statistically significantly lower in the GBM group than the GBN group at 24 hours postoperatively. The Medical Research Council scale was statistically significantly lower in the GBN group than the GBM group at 24 hours postoperatively. Postoperative time to first request of analgesics (hours) was statistically significantly longer in the GBN group than the GBM group, VAS at rest was statistically significantly lower in the GBN group than GBM group at 6th and 24th hours, VAS at movement showed no statistically significant differences between the two groups. Intraoperative fentanyl and postoperative analgesic requirements (pethidine mg/24 h) showed no statistically significant differences between the two groups.
Conclusions


Serratus anterior plane block using bupivacaine/nalbuphine provided effective postoperative analgesia, reduced postoperative pain than bupivacaine/magnesium sulfate in a mastectomy.",2020,"Postoperative time to first request of analgesics (hours) was statistically significantly longer in the GBN group than the GBM group, VAS at rest was statistically significantly lower in the GBN group than GBM group at 6th and 24th hours, VAS at movement showed no statistically significant differences between the two groups.","['Mastectomy', '40 ASA I and II female patients age 25 - 60 years underwent breast cancer surgery received the block before induction of general anesthesia']","['GBN', 'bupivacaine/magnesium sulfate versus bupivacaine/ nalbuphine', 'bupivacaine/magnesium sulphate', 'GBM', '\n\n\nMastectomy', 'bupivacaine 30 mL 0.25% and 500 mg magnesium sulphate, GBN (n = 20): (bupivacaine/nalbuphine', 'Bupivacaine/ Magnesium Sulfate Versus Bupivacaine/ Nalbuphine', 'bupivacaine/nalbuphine', 'bupivacaine 30 mL 0.25% and nalbuphine 0.2 mg/kg', 'bupivacaine/magnesium sulfate']","['Postoperative time to first request of analgesics (hours', 'Medical Research Council scale', 'sensory block, motor block, postoperative heart rate, noninvasive mean blood pressure: at 1, 6, 12, 24 h, postoperative time to first request of analgesics (hours), VAS at rest and movement at 1, 6, 12, 24 h, postoperative analgesic requirements (pethidine mg/24 h', 'sensory block', 'Intraoperative fentanyl and postoperative analgesic requirements', 'VAS at rest', 'postoperative pain']","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",40.0,0.0916149,"Postoperative time to first request of analgesics (hours) was statistically significantly longer in the GBN group than the GBM group, VAS at rest was statistically significantly lower in the GBN group than GBM group at 6th and 24th hours, VAS at movement showed no statistically significant differences between the two groups.","[{'ForeName': 'Doaa Abou El Kassim', 'Initials': 'DAEK', 'LastName': 'Rashwan', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and Pain Management, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed Rabea', 'Initials': 'AR', 'LastName': 'Mohammed', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and Pain Management, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Samaa A', 'Initials': 'SA', 'LastName': 'Kasem Rashwan', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and Pain Management, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed Sayed', 'Initials': 'AS', 'LastName': 'Abd El Basset', 'Affiliation': 'Radiology Department, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Hesham Ahmed', 'Initials': 'HA', 'LastName': 'Nafady', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}]",Anesthesiology and pain medicine,['10.5812/aapm.103141']
3070,32944564,Feasibility of Nasogastric Tube Insertion in Conscious Patients: Conventional Method vs. SORT Method.,"Background


Nasogastric tube (NGT) insertion is one of the most common procedures in the Emergency Department (EDs).
Objectives


This study aimed to evaluate the ease of NGT installation using the conventional method and the SORT method.
Methods


We conducted a randomized clinical trial in a university hospital on 200 patients who required NGT insertion during Mar-Sep, 2019. The patients were randomly divided into two groups of 100 patients each, receiving the SORT and conventional methods. Finally, the feasibility of NGT insertion was examined in the two groups using the frequency of NGT insertion attempts, pain during insertion (based on the VAS score of 1 - 10), patient satisfaction with the procedure (rating of 1 - 10), and incidence of complications.
Results


There was no significant difference between the two groups in terms of age, body mass index, sex, and history of NGT use. However, the mean patient satisfaction score was higher (P < 0.05), whereas the mean pain score was lower (P < 0.05) in the group receiving the conventional method compared to the other group. Moreover, there was no statistically significant difference in complications (P > 0.05).
Conclusions


The study showed that using the conventional method in comparison with the SORT method was significantly better for NGT insertion in conscious patients in terms of patient satisfaction and pain relief. Therefore, it is recommended not to use the SORT method in conscious patients.",2020,"However, the mean patient satisfaction score was higher (P < 0.05), whereas the mean pain score was lower (P < 0.05) in the group receiving the conventional method compared to the other group.","['conscious patients', 'Conscious Patients', '200 patients who required NGT insertion during Mar-Sep, 2019']","['Nasogastric Tube Insertion', '\n\n\nNasogastric tube (NGT) insertion']","['mean pain score', 'mean patient satisfaction score', 'incidence of complications', 'complications', 'patient satisfaction and pain relief']","[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}]","[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",200.0,0.0322086,"However, the mean patient satisfaction score was higher (P < 0.05), whereas the mean pain score was lower (P < 0.05) in the group receiving the conventional method compared to the other group.","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Afsharjoo', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Anesthesiology Research Team, Department of Anesthesiology, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kavous', 'Initials': 'K', 'LastName': 'Shahsavarinia', 'Affiliation': 'Emergency Medicine Research Team, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Rahmani', 'Affiliation': 'Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Anesthesiology and pain medicine,['10.5812/aapm.103747']
3071,32944694,Do Weekly Alerts From a Mobile Application Influence Reading During Residency?,"Background


The benefits of ""spaced education"" have been documented for residents in highly focused specialties. We found no published studies of spaced education in family medicine. In this study, we report on the feasibility of delivering weekly alerts from a mobile application (app) developed for exam preparation, to increase the reading of clinical information in the family medicine residency.
Methods



Design


This is a 2-phase mixed methods study. Phase one is a quasi-experimental study of resident reading of information related to priority topics in family medicine. Reading was documented by page views in a noncommercial mobile app.
Participants


All incoming first-year residents at two university training programs in Canada. The intervention group received one alert per week to priority topics on the app, beginning in their second month of residency. The control group was given access to the same app, but received no alerts.
Results


In this paper, we report the phase one preliminary findings. In the intervention group, 81 of 96 first year residents consented. At the control site, 79 of 85 residents consented. After 100 days, intervention group residents had viewed more pages of clinical information across all 99 priority topics (1,546 versus 900) and per topic (15.7 versus 9.1 pages,  P  < 0.0003). On average, each increase of one visit to the app following a weekly alert was associated with an increase of 3.2 visits to pages of clinical information in the app.
Conclusion


A weekly alert delivered via mobile app shows promise with respect to reading in the family medicine residency.",2017,"On average, each increase of one visit to the app following a weekly alert was associated with an increase of 3.2 visits to pages of clinical information in the app.
",['Participants\n\n\nAll incoming first-year residents at two university training programs in Canada'],[],['pages of clinical information'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0413292,"On average, each increase of one visit to the app following a weekly alert was associated with an increase of 3.2 visits to pages of clinical information in the app.
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Grad', 'Affiliation': 'McGill University Department of Family Medicine.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Pluye', 'Affiliation': 'McGill University Department of Family Medicine.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wong', 'Affiliation': 'The College of Family Physicians of Canada.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Brailovsky', 'Affiliation': 'The College of Family Physicians of Canada.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Moscovici', 'Affiliation': 'QuintilesIMS.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Kaczorowski', 'Affiliation': 'Université de Montréal Department of Family and Emergency Medicine.'}, {'ForeName': 'Charo', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'McGill University Department of Family Medicine.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Luconi', 'Affiliation': 'McGill University Continuing Professional Development Office.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Rousseau', 'Affiliation': 'Mt Sinai Hospital.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Karanofsky', 'Affiliation': 'McGill University Department of Family Medicine.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Delleman', 'Affiliation': 'McMaster University Department of Family Medicine.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kegel', 'Affiliation': 'McMaster University Department of Emergency Medicine.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Mercuri', 'Affiliation': 'McMaster University Department of Emergency Medicine.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kluchnyk', 'Affiliation': 'McGill University Department of Family Medicine.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Schabort', 'Affiliation': 'McMaster University Department of Family Medicine.'}]","PRiMER (Leawood, Kan.)",['10.22454/PRiMER.2017.243866']
3072,32944790,Acute effects of alcohol on error-elicited negative affect during a cognitive control task.,"RATIONALE


Alcohol intoxication can dampen negative affective reactions to stressors. Recently, it has been proposed that these acute anxiolytic effects of alcohol may extend to dampening of negative affective reactions to error commission during cognitive control tasks. Nonetheless, empirical verification of this claim is lacking.
OBJECTIVES


Test the acute effect of alcohol on negative affective reactions to errors during an effort-demanding cognitive control task.
METHODS


Healthy, young adult social drinkers (N = 96 [49 women], 21-36 years old) were randomly assigned to consume alcohol (0.80 g/kg; n = 33 [15 female]), active placebo (0.04 g/kg; n = 33 [18 women]), or a non-alcoholic control beverage (n = 30 [16 women]) before completing the Eriksen flanker task. Corrugator supercilii (Corr) activation, a psychophysiological index of negative affect, was tracked across the task. Two neurophysiological reactions to errors, the error-related negativity (ERN) and the error positivity (Pe), were also measured.
RESULTS


Erroneous actions increased Corr activation in the control and (to a lesser extent) placebo groups, but not in the alcohol group. Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups. Error-induced Corr activation was not coupled to post-error performance adjustments in any group.
CONCLUSIONS


The ability of alcohol to dampen error-related negative affect was verified. It was also shown that placebo alone can disrupt coupling of affective and (neuro)cognitive reactions to errors. Although its behavioral relevance remains to be demonstrated, more attention should be paid to the role of affect in action monitoring and cognitive control processes.",2020,"Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups.","['Healthy, young adult social drinkers (N\u2009=\u200996 [49 women], 21-36\xa0years old']","['consume alcohol', 'alcohol', 'placebo', 'active placebo', 'non-alcoholic control beverage (n\u2009=\u200930 [16 women]) before completing the Eriksen flanker task']","['Corrugator supercilii (Corr) activation', 'error-related negativity (ERN) and the error positivity (Pe', 'Corr activation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0224127', 'cui_str': 'Structure of corrugator supercilii muscle'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0266923,"Error-induced Corr activation was coupled to ERN and Pe in the control, but not in the alcohol and placebo groups.","[{'ForeName': 'Roberto U', 'Initials': 'RU', 'LastName': 'Cofresí', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, 65211, USA. cofresir@missouri.edu.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bartholow', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, 65211, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05619-4']
3073,32944800,"Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study.","BACKGROUND


Lipegfilgrastim has been shown to be non-inferior to pegfilgrastim for reduction of the duration of severe neutropenia (DSN) in breast cancer patients. This open-label, non-inferiority study assessed the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia.
PATIENT AND METHODS


One hundred and one patients (median age, 75 years) were randomized to lipegfilgrastim or pegfilgrastim (6 mg/cycle) during six cycles of R-CHOP21.
RESULTS


Lipegfilgrastim was non-inferior to pegfilgrastim for the primary efficacy endpoint, reduction of DSN in cycle 1. In the per-protocol population, mean (standard deviation) DSN was 0.8 (0.92) and 0.9 (1.11) days in the two groups, respectively; the adjusted mean difference between groups was - 0.3 days (95% confidence interval, - 0.70 to 0.19). Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of severe neutropenia in cycle 1 was 51% (21/41) in the lipegfilgrastim group and 52% (23/44) in the pegfilgrastim group. Very severe neutropenia (ANC < 0.1 × 10 9 /L) in cycle 1 was reported by 5 (12%) patients in the lipegfilgrastim group and 8 (18%) patients in the pegfilgrastim group. However, over all cycles, febrile neutropenia (strict definition) was reported by only 1 (2%) patient in each treatment group (during cycle 1 in the lipegfilgrastim group and cycle 6 in the pegfilgrastim group). The mean time to absolute neutrophil count recovery (defined as ≥ 2.0 × 10 9 /L) was 8.3 and 9.4 days in the two groups, respectively. Serious adverse events occurred in 46% of patients in each group; none were considered treatment-related. Eight patients died during the study (2 in the lipegfilgrastim group, 5 in the pegfilgrastim group, and 1 who died before starting study treatment). No deaths occurred during the treatment period, and all were considered to be related to the underlying disease.
CONCLUSIONS


This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov identifier NCT02044276; EudraCT number 2013-001284-23.",2020,"This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile.
","['elderly patients with aggressive B cell NHL receiving', 'One hundred and one patients (median age, 75 years', 'elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL', 'breast cancer patients', 'elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia']","['pegfilgrastim', 'myelosuppressive chemotherapy', 'lipegfilgrastim versus pegfilgrastim', 'lipegfilgrastim or pegfilgrastim']","['severe neutropenia', 'febrile neutropenia', 'efficacy and safety', 'Serious adverse events', 'deaths', 'Efficacy and safety', 'Very severe neutropenia', 'mean time to absolute neutrophil count recovery']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1827687', 'cui_str': 'Chemotherapy-induced neutropenia'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3640212', 'cui_str': 'lipegfilgrastim'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",,0.0414948,"This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile.
","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Private Practice Hematology Medical Oncology, Finkenhain 8, 67661, Kaiserslautern, Germany. hlink@kabelmail.de.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Illerhaus', 'Affiliation': 'Hematology, Oncology and Palliative Medicine Clinic, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Hematology, Oncology and Palliative Medicine Clinic, SLK-Clinics, Heilbronn, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salar', 'Affiliation': 'Hospital del Mar Paseo Marítimo, Hematology, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Depenbusch', 'Affiliation': 'Oncology Practice, Gütersloh, Gütersloh, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Köhler', 'Affiliation': 'Hematology and Oncology Collective Practice, Asklepios Clinic Specialist Medical Centre Langen, Langen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Internal Medicine Clinic I, Hematology, Oncology and Stem Cell Transplantation, University Clinic, Faculty of Freiburg, Freiburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mahlmann', 'Affiliation': 'Hematology/Oncology and Nephrology Clinic, Friedrich-Ebert-Hospital Neumünster, Neumünster, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zaiss', 'Affiliation': 'Interdiscliplinary Practice for Oncology and Hematology, Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lammerich', 'Affiliation': 'Teva Pharmaceuticals Industries, Ulm, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bias', 'Affiliation': 'Teva Pharmaceuticals Industries, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Buchner', 'Affiliation': 'Teva Pharmaceuticals Industries, Ulm, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05711-7']
3074,32944806,Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial.,"Repetitive transcranial magnetic stimulation (rTMS) has been proposed as an alternative option for treating tinnitus. rTMS is a noninvasive method in which repetitive magnetic stimulation is applied to the cortex; it is considered a therapeutic strategy that modulates the loudness of tinnitus. In this study, we performed a double-blind randomized clinical trial to compare the outcome of tinnitus treatment among (1) dual-site (auditory + prefrontal) rTMS stimulation, (2) auditory cortex only rTMS stimulation (AC), and (3) sham stimulation. The left primary auditory cortex and left dorsolateral prefrontal cortex (DLPFC) were targeted independently of handedness or tinnitus laterality. Dual-site and auditory only groups were treated with a total of 12,000 pulses, 2000 pulses over the AC and 1000 pulses over the DLPFC (group 1), 3000 pulses over the AC only (group 2), and daily for 4 consecutive days. Dual-site group exhibited a significantly better ΔTinnitus Handicap Inventory (ΔTHI) score at 4, 8 weeks and 12 weeks after rTMS treatments compared with pre-treatment. However, there was no effect in the auditory only group. Also, there was no effect in sham group when THI scores were compared with that of the pre-treatment. These results are in line with the former studies that reported a better treatment effect by multiple site rTMS.",2020,The left primary auditory cortex and left dorsolateral prefrontal cortex (DLPFC) were targeted independently of handedness or tinnitus laterality.,['Tinnitus Patients'],"['tinnitus treatment among (1) dual-site (auditory\u2009+\u2009prefrontal) rTMS stimulation, (2) auditory cortex only rTMS stimulation (AC), and (3) sham stimulation', 'Dual-site rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['THI scores', 'ΔTinnitus Handicap Inventory (ΔTHI) score']","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0272238', 'cui_str': 'Transient hypogammaglobulinemia of infancy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",12000.0,0.139234,The left primary auditory cortex and left dorsolateral prefrontal cortex (DLPFC) were targeted independently of handedness or tinnitus laterality.,"[{'ForeName': 'Tae-Soo', 'Initials': 'TS', 'LastName': 'Noh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Jeong-Sug', 'Initials': 'JS', 'LastName': 'Kyong', 'Affiliation': 'Department of Audiology and Speech-Language Pathology, Audiology Institute, Hallym University of Graduate Studies, Seoul, Korea.'}, {'ForeName': 'Moo Kyun', 'Initials': 'MK', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Seung Ha', 'Initials': 'SH', 'LastName': 'Oh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea.'}, {'ForeName': 'Myung-Whan', 'Initials': 'MW', 'LastName': 'Suh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul National University College of medicine, Yongon-Dong, Chongno-Gu, Seoul, 110-744, Korea. drmung@naver.com.'}]",Brain topography,['10.1007/s10548-020-00797-y']
3075,32944843,"Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study.","PURPOSE


Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine.
METHODS


CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18-65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed.
RESULTS


A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: -33.58 ± 2.11 (GMB 120 mg) and -32.67 ± 2.04 (GMB 240 mg).
CONCLUSION


Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.",2020,Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period.,"['Patients aged 18-65\xa0years with diagnosis of migraine (≥\u20094 migraine headache days per month) as defined by International Classification of Headache Disorders', 'patients with migraine', 'patients with episodic or chronic migraine', '135 patients']","['galcanezumab (GMB', 'galcanezumab', 'Galcanezumab', 'subcutaneous GMB', 'GMB']","['Role function-restrictive (RF-R) domain (overall least squares (LS', 'Functional impairment and disability', 'Mean (SD) baseline MSQ total scores', 'Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS', 'For MIDAS, mean (SD) total scores', 'health-related quality of life and decreased disability', 'MSQ and MIDAS total scores and all individual item/domain scores', 'PRO measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]",135.0,0.0199321,Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period.,"[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA. ford_janet@lilly.com.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McAllister', 'Affiliation': 'New England Institute for Neurology and Headache, Stamford, USA.'}, {'ForeName': 'Sreelatha', 'Initials': 'S', 'LastName': 'Akkala', 'Affiliation': 'Eli Lilly Services India Pvt Ltd, Bengaluru, India.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sexson', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ayer', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02632-0']
3076,32949322,A disease progression model of longitudinal lung function decline in idiopathic pulmonary fibrosis patients.,"Pirfenidone and nintedanib are the first two FDA-approved therapies for treatment of idiopathic pulmonary fibrosis (IPF). The clinical programs for pirfenidone and nintedanib included 1132 patients in the placebo arms and 1691 patients in the treatment arms across 6 trials. We developed a disease progression model to characterize the observed variability in lung function decline, measured as percent predicted forced vital capacity (%p-FVC), and its decrease in decline after treatment. The non-linear longitudinal change in %p-FVC was best described by a Weibull function. The median decreased decline in %p-FVC after treatment was estimated to be 1.50% (95% CI [1.12, 1.79]) and 1.96% (95% CI [1.47, 2.36]) at week 26 and week 52, respectively. Smoking status, weight, %p-FVC, %p-DLco and oxygen use at baseline were identified as significant covariates affecting decline in %p-FVC. The decreased decline in %p-FVC were observed among all subgroups of interest, of which the effects were larger at 1 year compared to 6 months. Based on the disease progression model smoking status and oxygen use at baseline may affect the treatment effect size. At week 52, the decreased decline in %p-FVC for current smokers and patients with oxygen use at baseline were 1.56 (90% CI [1.02, 1.99]) and 2.32 (90% CI [1.74, 2.86]), respectively. These prognostic factors may be used to enrich studies with patients who are more likely to respond to treatment, by demonstrating a lesser decline in lung function, and therefore provide the potential to allow for IPF studies with smaller study populations or shorter durations.",2020,"The decreased decline in %p-FVC were observed among all subgroups of interest, of which the effects were larger at 1 year compared to 6 months.","['idiopathic pulmonary fibrosis (IPF', '1132 patients in the placebo arms and 1691 patients in the treatment arms across 6 trials', 'idiopathic pulmonary fibrosis patients']",['Pirfenidone and nintedanib'],[],"[{'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}]",[],,0.0254304,"The decreased decline in %p-FVC were observed among all subgroups of interest, of which the effects were larger at 1 year compared to 6 months.","[{'ForeName': 'Youwei', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Dinko', 'Initials': 'D', 'LastName': 'Rekić', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Miya O', 'Initials': 'MO', 'LastName': 'Paterniti', 'Affiliation': 'Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Jianmeng', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Marathe', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Badrul A', 'Initials': 'BA', 'LastName': 'Chowdhury', 'Affiliation': 'Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Banu A', 'Initials': 'BA', 'LastName': 'Karimi-Shah', 'Affiliation': 'Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Yaning', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. Yaning.Wang@fda.hhs.gov.'}]",Journal of pharmacokinetics and pharmacodynamics,['10.1007/s10928-020-09718-9']
3077,32949370,"Rapidity of CNS Effect on Photoparoxysmal Response for Brivaracetam vs. Levetiracetam: A Randomized, Double-blind, Crossover Trial in Photosensitive Epilepsy Patients.","INTRODUCTION


Both levetiracetam (LEV) and brivaracetam (BRV) eliminate the electroencephalogram photoparoxysmal response (PPR) in the human phase IIa photosensitivity model of epilepsy. The physiochemical properties of BRV differ from those of LEV, having higher potency and lipophilicity plus 10- to 15-fold greater affinity for synaptic vesicle glycoprotein 2A.
OBJECTIVE


We compared the rapidity of the effects of both drugs in the central nervous system (CNS) of patients with photosensitive epilepsy using time to PPR elimination post-intravenous infusion as a pharmacodynamic endpoint.
METHODS


Using a randomized, double-blind, two-period, balanced, crossover design, we tested patients with photosensitive epilepsy with equipotent milligram doses of intravenous LEV 1500 mg versus BRV 100 mg post-15-min intravenous infusion (part 1) and post-5-min intravenous infusion (part 2, same doses). Eight patients per part were deemed sufficient with 80% power to determine a 70% reduction for intravenous BRV:LEV intrapatient time ratio to PPR elimination, with a 0.05 two-sided significance level. Plasma antiseizure medicine concentrations were measured using liquid chromatography/mass spectrometry.
RESULTS


Nine patients [six women; mean age 27.8 years (range 18-42)] completed the study; seven of these participated in both parts 1 and 2. In 31 of 32 instances, patients experienced PPR elimination. In mixed-effects model time analysis, BRV eliminated PPRs more quickly than did LEV (median 2 vs. 7.5 min, respectively). However, no statistically significant difference in BRV:LEV time ratio to PPR elimination was observed for two of our multiple primary outcomes: for the 15-min infusion alone (p = 0.22) or the 5-min infusion alone (p = 0.11). However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016). For our remaining primary outcome, parts 1 and 2 data combined, the median intrapatient BRV:LEV time ratio was 0.39 [95% confidence interval (CI) 0.16-0.91], i.e., PPR elimination was 61% faster with BRV, p = 0.039. PPR was completely eliminated in ≤ 2 min in 11 patients with BRV and in four patients with LEV. No period or carryover effects were seen. No serious or severe adverse effects occurred. At PPR elimination (n = 16), median plasma [BRV] was 250 ng/mL (range 30-4100) and median plasma [LEV] was 28.35 μg/mL (range 1-86.7).
CONCLUSION


Outcome studies directly comparing LEV and BRV are needed to define the clinical utility of the response with BRV, which was several minutes faster than that with LEV.
CLINICAL TRIALS


ClinTrials.gov Identifier = NCT03580707; registered 07-09-18.",2020,"However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016).","['Photosensitive Epilepsy Patients', 'Nine patients [six women; mean age 27.8\xa0years (range 18-42)] completed the study; seven of these participated in both parts 1 and 2', 'patients with photosensitive epilepsy with equipotent milligram doses of', 'patients with photosensitive epilepsy']","['levetiracetam (LEV) and brivaracetam (BRV', 'Levetiracetam', 'intravenous LEV 1500\xa0mg versus BRV 100\xa0mg post-15-min intravenous infusion (part 1) and post-5-min intravenous infusion']","['PPR elimination', 'median plasma [BRV', 'BRV:LEV time ratio to PPR elimination', 'median plasma [LEV', 'No serious or severe adverse effects', 'Plasma antiseizure medicine concentrations', 'median intrapatient BRV:LEV time ratio', 'PPR', 'BRV', 'intravenous BRV:LEV intrapatient time ratio to PPR elimination']","[{'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439210', 'cui_str': 'mg'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3893014', 'cui_str': 'Levetiracetam 1500 MG [Elepsia]'}, {'cui': 'C4083398', 'cui_str': 'Brivaracetam 100 MG'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]",11.0,0.244532,"However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016).","[{'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Reed', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, West Virginia University, 1124 Health Science Center North, Morgantown, WV, 26506-9520, USA. ronald.reed@hsc.wvu.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Lippmann', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA.'}, {'ForeName': 'Rene M J C', 'Initials': 'RMJC', 'LastName': 'Eijkemans', 'Affiliation': 'Head of Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Dorothee G A', 'Initials': 'DGA', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center, Utrecht University, Utrecht, The Netherlands.'}]",CNS drugs,['10.1007/s40263-020-00761-1']
3078,32949374,Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185): subgroup analysis in Japanese patients.,"The global, randomized, open-label KEYNOTE-185 study closed early after an interim analysis showed an unfavorable benefit-risk profile with pembrolizumab plus lenalidomide and low-dose dexamethasone (Rd) versus Rd alone in treatment-naive, transplant-ineligible multiple myeloma. This subgroup analysis reported outcomes in the Japanese population. Patients were randomly assigned (1:1) to pembrolizumab plus Rd or Rd alone, stratified by age and International Staging System. The primary end point was progression-free survival (PFS). Fifty-two Japanese patients were randomly assigned to pembrolizumab plus Rd (n = 27) or Rd (n = 25). The median follow-up was 7.2 months (range, 0.4-13.8). The median PFS was not reached (NR); 6-month PFS was 91.2% versus 86.2% with pembrolizumab plus Rd versus Rd [hazard ratio (HR), 0.31; 95% CI, 0.06-1.63]. The median overall survival (OS) was NR; 6-month OS was 96.2% versus 95.7% with pembrolizumab plus Rd versus Rd (HR, 0.33; 95% CI, 0.03-3.72). With pembrolizumab plus Rd versus Rd, grade 3-5 adverse events occurred in 70.4% versus 69.6% of patients; serious adverse events occurred in 40.7% versus 52.5%. Although in the Japanese subgroup of KEYNOTE-185 adding pembrolizumab to Rd did not show an unfavorable risk-benefit, the analysis is limited by short follow-up and small sample size, affecting generalizability of the results.",2020,"The median PFS was not reached (NR); 6-month PFS was 91.2% versus 86.2% with pembrolizumab plus Rd versus Rd [hazard ratio (HR), 0.31; 95% CI, 0.06-1.63].","['treatment-naive, transplant-ineligible multiple myeloma', 'Fifty-two Japanese patients', 'Japanese patients']","['pembrolizumab plus Rd or Rd alone, stratified by age and International Staging System', 'pembrolizumab plus Rd', 'Pembrolizumab plus lenalidomide and dexamethasone', 'pembrolizumab plus lenalidomide and low-dose dexamethasone (Rd) versus Rd alone']","['adverse events', 'median overall survival (OS', '6-month OS', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",52.0,0.111537,"The median PFS was not reached (NR); 6-month PFS was 91.2% versus 86.2% with pembrolizumab plus Rd versus Rd [hazard ratio (HR), 0.31; 95% CI, 0.06-1.63].","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'National Hospital Organization Disaster Medical Center, 3256 Midori, Tachikawa, Tokyo, Japan. ntakezak@gmail.com.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kosugi', 'Affiliation': 'Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'National Hospital Organization, Shibukawa Medical Center, Shibukawa, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Kobe City Medical Center, Kobe, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Miki', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Kindai University Hospital, Osaka-Sayama, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sunami', 'Affiliation': 'National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Teshima', 'Affiliation': 'Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Onishi', 'Affiliation': 'Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kizaki', 'Affiliation': 'Saitama Medical Center, Saitama Medical University, Kawagoe-shi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Izutsu', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Razi', 'Initials': 'R', 'LastName': 'Ghori', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Farooqui', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck & Co., Inc., Kentilworth, NJ, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shimamoto', 'Affiliation': 'MSD K.K, Tokyo, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Japanese Red Cross Medical Center, Tokyo, Japan.'}]",International journal of hematology,['10.1007/s12185-020-02953-3']
3079,32949382,A novel 'practical body image' therapy for adolescent inpatients with anorexia nervosa: a randomised controlled trial.,"PURPOSE


To determine the potential effectiveness of a novel 10-week manualised Practical Body Image therapy (PBI) with mirror exposure (ME), when used as an adjuvant to an intensive treatment package (TAU) in adolescent inpatients with Anorexia Nervosa (AN). To evaluate the effectiveness of ME in an adolescent population.
METHODS


Using a randomised control design, 40 girls aged 11-17 years with AN were assigned to PBI with TAU (n = 20) and TAU alone (n = 20). Both groups completed self-report measures of body image at week 1 and week 10 of the study to measure the potential effectiveness of PBI. The PBI group completed measures at week 7 to evaluate the ME component.
RESULTS


31 participants completed the study; 16 TAU, 15 PBI. PBI participants had greater improvement in all outcomes than TAU participants. Medium effect sizes were seen for self-reported weight concern, body image avoidance in terms of clothing and body image anxiety. ME produced effect sizes in self-reported body image avoidance in terms of clothing and grooming that were greater than 0.40, n = 14.
CONCLUSION


The findings demonstrate that PBI supports an intensive inpatient treatment package and addresses elements of negative body image. PBI was beneficial for addressing body image dissatisfaction with improvements in weight concerns, body image avoidance and physical appearance trait anxiety following the ME component. The magnitude of the effect sizes is comparable to previous studies. Positive qualitative feedback indicated the intervention was acceptable to users. PBI is a promising new adjuvant treatment for AN.
EMB RATING


Level I: randomized controlled trial.",2020,"Medium effect sizes were seen for self-reported weight concern, body image avoidance in terms of clothing and body image anxiety.","['adolescent population', 'adolescent inpatients with anorexia nervosa', '31 participants completed the study; 16 TAU, 15 PBI', '40 girls aged 11-17\xa0years with AN', 'adolescent inpatients with Anorexia Nervosa (AN']","['novel 10-week manualised Practical Body Image therapy (PBI) with mirror exposure (ME', 'PBI with TAU', 'TAU alone', 'intensive treatment package (TAU', 'ME']","['Positive qualitative feedback', 'weight concerns, body image avoidance and physical appearance trait anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0750731', 'cui_str': 'Body, Physical Appearance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",40.0,0.0617088,"Medium effect sizes were seen for self-reported weight concern, body image avoidance in terms of clothing and body image anxiety.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Biney', 'Affiliation': 'Newbridge House, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Astbury', 'Affiliation': 'Newbridge House, Birmingham, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Haines', 'Affiliation': 'Newbridge House, Birmingham, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Grant', 'Affiliation': 'Newbridge House, Birmingham, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Malone', 'Affiliation': 'Newbridge House, Birmingham, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hutt', 'Affiliation': 'Newbridge House, Birmingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Matthews', 'Affiliation': 'Newbridge House, Birmingham, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Morgan', 'Affiliation': ""St. George's, University of London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""St. George's, University of London, London, UK.""}, {'ForeName': 'J Hubert', 'Initials': 'JH', 'LastName': 'Lacey', 'Affiliation': 'Newbridge House, Birmingham, UK. hlacey@sgul.ac.uk.'}]",Eating and weight disorders : EWD,['10.1007/s40519-020-00997-2']
3080,32948289,Patients with temporomandibular pain who receive propranolol are more likely to experience pain reduction than those who receive a placebo.,,2020,,['Patients with temporomandibular pain who receive'],"['placebo', 'propranolol']",['experience pain reduction'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0263757,,"[{'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Brignardello-Petersen', 'Affiliation': ''}]",Journal of the American Dental Association (1939),['10.1016/j.adaj.2020.07.004']
3081,32948359,Increasing the low residue diet to 3 days does not improve the bowel cleansing in hard to prepare patients: Post hoc analysis of a randomized controlled trial.,"BACKGROUND


Recent evidence suggests that the number of low residue diet (LRD) days does not influence the bowel cleansing quality in non-selected patients. However, there are not data in the subgroup of patients with risk factors of inadequate bowel cleansing.
OBJECTIVE


The aim of this study was to assess whether a 3-day LRD improved the bowel cleansing quality in patients with risk factors of poor bowel cleansing.
PATIENTS AND METHODS


Post hoc analysis of a randomized controlled trial carried out between December 2017 and March 2018 in a tertiary care hospital. Patients with high risk of poor bowel cleansing were selected following a validated score. The patients were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the main outcome.
RESULTS


135 patients (1-day LRD group=67, 3-day LRD=68) were included. The rate of adequate cleansing quality was not significantly different between the groups in the ITT analysis: 76.1%, 95% CI: [64.6-84.8] vs. 79.4%, 95% CI: [68.2-87.4]; odds ratio (OR) 1.2, 95% CI [0.54-2.73]) or in the PP analysis: 77.3%, 95% CI: [65.7-85.8] vs. 80.3%, 95% CI: [69.0-88.3]; OR 1.2, 95% CI [0.52-2.77]). Compliance with the diet or cleansing solution, satisfaction or difficulties with the LRD and the polyp/adenoma detection rates were not significantly different.
CONCLUSION


Our results suggest that 1-day LRD is not inferior to 3-day LRD in patients with risk factors of inadequate bowel cleansing.",2020,"The rate of adequate cleansing quality was not significantly different between the groups in the ITT analysis: 76.1%, 95% CI: [64.6-84.8] vs. 79.4%, 95% CI: [68.2-87.4]; odds ratio (OR) 1.2, 95% CI [0.54-2.73]) or in the PP analysis: 77.3%, 95% CI: [65.7-85.8] vs. 80.3%, 95% CI: [69.0-88.3]; OR 1.2, 95% CI [0.52-2.77]).","['Patients with high risk of poor bowel cleansing', 'patients with risk factors of poor bowel cleansing', '135 patients (1-day LRD group=67, 3-day LRD=68) were included', 'patients with risk factors of inadequate bowel cleansing', 'December 2017 and March 2018 in a tertiary care hospital']","['3-day LRD', '1-day LRD or 3-day LRD', '2-L split-dose of polyethylene glycol plus ascorbic acid', 'Intention-to-treat (ITT) and per-protocol (PP']","['rate of adequate cleansing quality', 'satisfaction or difficulties with the LRD and the polyp/adenoma detection rates', 'bowel cleansing', 'bowel cleansing quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",,0.285556,"The rate of adequate cleansing quality was not significantly different between the groups in the ITT analysis: 76.1%, 95% CI: [64.6-84.8] vs. 79.4%, 95% CI: [68.2-87.4]; odds ratio (OR) 1.2, 95% CI [0.54-2.73]) or in the PP analysis: 77.3%, 95% CI: [65.7-85.8] vs. 80.3%, 95% CI: [69.0-88.3]; OR 1.2, 95% CI [0.52-2.77]).","[{'ForeName': 'Antonio Z', 'Initials': 'AZ', 'LastName': 'Gimeno-García', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain. Electronic address: antozeben@gmail.com.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'de la Barreda-Heuser', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reygosa', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Hernández', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Amaral', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mascareño', 'Affiliation': 'Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nicolás-Pérez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Jiménez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Lara', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Anjara', 'Initials': 'A', 'LastName': 'Hernández', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Felipe', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Baute', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Alarcon-Fernández', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hernandez-Guerra', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romero', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Alonso', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Yanira', 'Initials': 'Y', 'LastName': 'González', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Zaida', 'Initials': 'Z', 'LastName': 'Adrian', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Goretti', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Hernandez', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Delgado', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Quintero', 'Affiliation': 'Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Spain; Servicio de Endocrinología y Nutrición, Hospital San Juan de Dios, Santa Cruz de Tenerife, Spain.'}]",Gastroenterologia y hepatologia,['10.1016/j.gastrohep.2020.06.016']
3082,32948386,Correlation between Post-Procedure Residual Thrombus and Clinical Outcome in Deep Vein Thrombosis Patients Receiving Pharmacomechanical Thrombolysis in a Multi-center Randomized Trial.,"PURPOSE


To evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT).
MATERIALS AND METHODS


Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multi-center randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale. The physician operators recorded their visual assessments of thrombus regression and venous flow. These immediate post-procedure results were correlated with patient outcomes at 1, 12, and 24 months.
RESULTS


PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments). At procedure end, spontaneous venous flow was present in 99% of iliofemoral venous segments and in 89% of femoral-popliteal venous segments. For the overall proximal DVT population, and for the femoral-popliteal DVT subgroup, post-PCDT thrombus volume did not correlate with 1-month or 24-month outcomes. For the iliofemoral DVT subgroup, over 1 and 24 months, symptom severity scores were higher (worse), and venous disease-specific quality of life (QOL) scores were lower (worse) in patients with greater post-PCDT thrombus volume, with the difference reaching statistical significance for the 24-month Villalta post-thrombotic syndrome (PTS) severity score (P = .0098). Post-PCDT thrombus volume did not correlate with 12-month valvular reflux.
CONCLUSIONS


PCDT successfully removes thrombus in acute proximal DVT. However, the residual thrombus burden at procedure end does not correlate with the occurrence of PTS during the subsequent 24 months. In iliofemoral DVT, lower residual thrombus burden correlates with reduced PTS severity and possibly also with improved venous QOL and fewer early symptoms.",2020,"RESULTS


PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments).","['Deep Vein Thrombosis Patients Receiving', 'Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multi-center randomized trial were reviewed']","['Pharmacomechanical Thrombolysis', 'pharmacomechanical catheter-directed thrombolysis (PCDT']","['visual assessments of thrombus regression and venous flow', '24-month Villalta post-thrombotic syndrome (PTS) severity score', 'substantial thrombus removal', 'symptom severity scores', '12-month valvular reflux', 'venous disease-specific quality of life (QOL) scores', 'spontaneous venous flow', 'Quantitative thrombus resolution', 'venous QOL']","[{'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0429874', 'cui_str': 'Venous flow'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0277919', 'cui_str': 'Venous stasis syndrome'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0235522', 'cui_str': 'Disorder of vein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",317.0,0.0542837,"RESULTS


PCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments).","[{'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': ""St. Joseph's Hospital, Orange, California.""}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Lancia', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine, McGill University, Division of Internal Medicine & Center for Clinical Epidemiology, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Weinberg', 'Affiliation': 'Vascular Medicine Section, Cardiology Division, Vascular Ultrasound Core Laboratory (VasCore), Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Ezana M', 'Initials': 'EM', 'LastName': 'Azene', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Nilesh H', 'Initials': 'NH', 'LastName': 'Patel', 'Affiliation': 'Total Vascular Care Centers LLC, Peoria, Arizona.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, 510 S. Kingshighway Blvd., Box 8131, St. Louis, MO, 63110. Electronic address: vedanthams@wustl.edu.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.07.010']
3083,32948387,Double-Needle Lavage for Effective Treatment of Difficult-Aspiration Thyroid Cystic Nodules: A Single-Center Controlled Trial.,"PURPOSE


To explore the safety and efficacy of double-needle lavage (DNL) in the treatment of difficult aspiration thyroid cystic nodules.
MATERIALS AND METHODS


This single-center, prospective, randomized controlled trial was conducted using 100 thyroid cysts from 100 patients who were treated in our hospital from January 2018 to August 2019. These patients were placed into 2 groups; group A including 40 patients treated with single-needle aspiration (SNA), and group B including 60 patients treated with DNL. The safety and efficacy of these 2 aspiration methods were compared.
RESULTS


Ten patients in group A that did not benefit from SNA were transferred to group B. No complication occurred in either group. Notably, DNL showed significantly higher efficacy than SNA. This was evidenced by the higher extraction rate of materials in the capsule (A vs B, 91 ± 6.51% vs 98.45 ± 1.74%, P < .001) and overall nodule volume reduction rate in group B (A vs B, 87.54 ± 7.84% vs 95.62 ± 3.66%, P < .001). In group B, patients who received DNL treatment with 2 needles pointed at the upper and lower extremes of the cystic nodules (B2) exhibited significantly better aspiration effects compared to patients in which the 2 needles were pointed at the same ultrasound plane (B1) (P < .05), especially for patients with maximum diameter of nodules ≥3 cm (P < .01).
CONCLUSIONS


DNL treatment could efficiently and safely replace cystic material from thyroid gland. Moreover, our results indicate that DNL treatment in which 2 needles are pointed at the 2 extremes of cystic nodules yields higher efficacy in patients with maximum diameter of nodules ≥3 cm.",2020,B. No complication occurred in either group.,"['100 thyroid cysts from 100 patients who were treated in our hospital from January 2018 to August 2019', 'Difficult-Aspiration Thyroid Cystic Nodules']","['single-needle aspiration (SNA', 'DNL', 'double-needle lavage (DNL', 'Double-Needle Lavage']","['safety and efficacy', 'overall nodule volume reduction rate', 'complication', 'higher extraction rate of materials', 'aspiration effects']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0162299', 'cui_str': 'Cyst of thyroid'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C4302819', 'cui_str': 'Cystic nodule'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0235062,B. No complication occurred in either group.,"[{'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Xiaoyin', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ping', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Bingwei', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Min', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Zhai', 'Initials': 'Z', 'LastName': 'Bo', 'Affiliation': 'Department of Tumor Interventional Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, 160# Pujian Road, Shanghai, 200127, China. Electronic address: zhaiboshi@sina.com.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.03.005']
3084,32948397,Correction of anemia by dapagliflozin in patients with type 2 diabetes.,"AIMS


Anemia is common in type 2 diabetes (T2D), particularly in patients with kidney impairment, and often goes unrecognized. Dapagliflozin treatment increases hemoglobin and serum erythropoietin levels. We investigated the effect of dapagliflozin 10-mg/day on hemoglobin in T2D patients with and without anemia.
METHODS


Data from 5325 patients from 14 placebo-controlled, dapagliflozin-treatment studies of at least 24-weeks duration were pooled. Dapagliflozin's effects (vs. placebo) on hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia were evaluated.
RESULTS


At baseline, 13% of all T2D patients and 28% of those with chronic kidney disease (eGFR <60 mL/min/1.73 m 2 ) had anemia. Hemoglobin increased continuously to at least week 8 and was sustained throughout 24-weeks follow-up in dapagliflozin-treated patients. Serum albumin increased in dapagliflozin-treated patients at week 4 and remained stable thereafter. Dapagliflozin was well tolerated and corrected anemia in 52% of patients with anemia at baseline (placebo: 26%). Incidences of new-onset anemia were lower in dapagliflozin-treated (2.3%) versus placebo-treated (6.5%) patients.
CONCLUSIONS


Treatment with dapagliflozin can correct and prevent anemia in T2D patients. A gradual increase in hemoglobin beyond week 4 may indicate an erythropoiesis-stimulating effect of sodium-glucose cotransporter 2 inhibition.",2020,"Dapagliflozin's effects (vs. placebo) on hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia were evaluated.
","['patients with type 2 diabetes', 'T2D patients', 'T2D patients with and without anemia', 'patients with kidney impairment', 'Data from 5325 patients from 14 placebo-controlled, dapagliflozin-treatment studies of at least 24-weeks duration were pooled']","['placebo', 'Dapagliflozin', 'dapagliflozin']","['hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia', 'Serum albumin', 'tolerated and corrected anemia', 'hemoglobin and serum erythropoietin levels', 'anemia', 'Hemoglobin', 'hemoglobin', 'Incidences of new-onset anemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",5325.0,0.0698855,"Dapagliflozin's effects (vs. placebo) on hemoglobin, serum albumin, estimated glomerular filtration rate (eGFR), systolic blood pressure, body weight, and safety in patients with and without anemia were evaluated.
","[{'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'Late-stage Development Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, the Netherlands; George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'George Institute for Global Health, Sydney, Australia; Department of Renal Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-stage Development Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Research and Early Development, Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sartipy', 'Affiliation': 'Late-stage Development Cardiovascular Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; Systems Biology Research Center, School of Bioscience, University of Skövde, Skövde, Sweden.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Cain', 'Affiliation': 'Bogier Clinical and IT Solutions, Raleigh, NC, United States.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. Electronic address: correarotter@gmail.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107729']
3085,32948471,Grip Strength and Demographic Variables Estimate Appendicular Muscle Mass Better Than Bioelectrical Impedance in Taiwanese Older Persons.,"OBJECTIVES


This study aimed to develop an equation model combining physical fitness and anthropometric parameters and compare its results with those of bioelectrical impedance analysis (BIA)-measured lean mass (LM) using dual-energy X-ray absorptiometry (DXA)-measured appendicular muscle mass (AMM) as reference.
DESIGN


Observational analysis.
SETTING AND PARTICIPANTS


Healthy community-dwelling older subjects.
METHODS


A total of 1020 participants were randomly allocated to the development group (development group, n = 510) or the cross-validation group (validation group, n = 510). Body composition was measured using both DXA and BIA, and physical fitness parameters, including grip strength, timed stepping test, sit-to-stand test, flexibility, and walking speed were also assessed. A prediction equation model of AMM by stepwise linear regression analysis that included or excluded 1 independent variable at each step, based on the P value of significance (P < .05), was developed.
RESULTS


Using weight, sex, height, and handgrip strength as independent variables, the equation AMM = -9.833 + 0.397 × weight (kg) + 4.433 × sex + 0.121 × height (cm) + 0.061 × handgrip strength (kg) best predicts DXA-measured AMM (adjusted R 2  = 0.914, SEE = 2.062, P < .001). The predicted AMM was more highly correlated with DXA-measured AMM than the commonly used BIA-measured LM (R 2 = 0.9158 and 0.8427, respectively, both P < .001). Using DXA-measured AMM as reference, the Bland-Altman plot showed mean differences of -0.03 kg and -0.12 kg, with limits of agreement of -3.98 to 3.92 kg and -5.97 to 5.73 kg for the predicted AMM and BIA-measured AMM, respectively.
CONCLUSIONS AND IMPLICATIONS


The proposed equation offers a practical alternative method for estimating AMM that is less facility-dependent and more easy to use and affordable than instrumental studies.",2020,"× handgrip strength (kg) best predicts DXA-measured AMM (adjusted R 2  = 0.914, SEE = 2.062, P < .001).","['4.433\xa0×\xa0sex\xa0+\xa00.121\xa0×\xa0height (cm)\xa0+\xa00.061', '1020 participants', 'Taiwanese Older Persons', 'Healthy community-dwelling older subjects']",['9.833\xa0+\xa00.397\xa0×\xa0weight (kg)\xa0'],"['DXA and BIA, and physical fitness parameters, including grip strength, timed stepping test, sit-to-stand test, flexibility, and walking speed', 'Body composition', '×\xa0handgrip strength (kg) best predicts DXA-measured AMM', 'Grip Strength and Demographic Variables Estimate Appendicular Muscle']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",1020.0,0.0451526,"× handgrip strength (kg) best predicts DXA-measured AMM (adjusted R 2  = 0.914, SEE = 2.062, P < .001).","[{'ForeName': 'Ming-Yen', 'Initials': 'MY', 'LastName': 'Hsiao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ke-Vin', 'Initials': 'KV', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Chin', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Department of Family Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Der-Sheng', 'Initials': 'DS', 'LastName': 'Han', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Community and Geriatric Medicine Research Center, National Taiwan University Hospital, Bei-Hu Branch, Taipei, Taiwan; Health Science and Wellness Center, National Taiwan University, Taipei, Taiwan. Electronic address: dshan1121@yahoo.com.tw.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.08.003']
3086,32944575,Effects of Foot Massage on Pain Severity during Change Position in Critically Ill Trauma Patients; A Randomized Clinical Trial.,"Objective


To determine the effects of foot massage on pain severity during in unconscious trauma patients admitted to the intensive care unit (ICU).
Methods


In this randomized clinical trial (RCT), 80 unconscious trauma patients admitted in the ICU of a hospital in an urban area of Iran were included using the convenience sampling method. They were randomly assigned to the intervention and control groups (n=40 in each group). In both groups, the intensity of pain was measured immediately, 10 minutes after the first change position and without any intervention before the change of position using the Critical Care Pain Observation Tool (CCPOT). In the intervention group, before the second position change, classic foot massage was performed for 20 minutes, but the control group received routine care. Pain was re-evaluated after the change position at desired times. The pain intensity was compared between the two study groups.
Results


The baseline characteristics were comparable between the two study groups and no difference was found. There was no statistically significant difference between the mean scores of pain after the change of position (immediately and ten minutes later) before the intervention in the groups (p=0.915 and 0.660, respectively). However, after the intervention, the pain intensity was significantly lower in the intervention groups compared to the control group (p<0.001).
Conclusion


Foot massage decreases the pain intensity related to the change of position in unconscious trauma patients admitted in the ICU. Due to its simplicity and low cost, this method can be used along with analgesic drugs to reduce pain in patients.",2020,"There was no statistically significant difference between the mean scores of pain after the change of position (immediately and ten minutes later) before the intervention in the groups (p=0.915 and 0.660, respectively).","['Critically Ill Trauma Patients', 'unconscious trauma patients admitted in the ICU', 'unconscious trauma patients admitted to the intensive care unit (ICU', '80 unconscious trauma patients admitted in the ICU of a hospital in an urban area of Iran were included using the convenience sampling method']","['control group received routine care', 'foot massage', 'Foot Massage', 'Foot massage']","['Pain Severity', 'mean scores of pain', 'intensity of pain', 'pain intensity', 'Pain', 'pain severity']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0437281,"There was no statistically significant difference between the mean scores of pain after the change of position (immediately and ten minutes later) before the intervention in the groups (p=0.915 and 0.660, respectively).","[{'ForeName': 'Khodayar', 'Initials': 'K', 'LastName': 'Oshvandi', 'Affiliation': 'Mother and Child Care Research Center, Nursing and Midwifery School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Veladati', 'Affiliation': 'Medical Surgical Nursing Student, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mahmoodi', 'Affiliation': 'Department of Biostatistics, School of Health and Nutrition, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Farshid', 'Initials': 'F', 'LastName': 'Rahimi Bashar', 'Affiliation': 'Anesthesia and Critical Care Department, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Azizi', 'Affiliation': 'Chronic Diseases (Home Care) Research Centre, Malayer Nursing School, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Bulletin of emergency and trauma,['10.30476/BEAT.2020.86094']
3087,32944578,Effects of Topical Sesame Oil Extracted from Tahini ( Ardeh ) on Pain Severity in Trauma Patients: A Randomized Double-Blinded Placebo-Controlled Clinical Trial.,"Objective


To investigate the effects of sesame oil extracted from tahini (Ardeh) on pain severity in patients with upper or lower limbs trauma.
Methods


This double-blinded randomized clinical trial study was conducted on 120 patients with upper or lower trauma in Shahid Rajaee Hospital, Shiraz, Iran, from May the 1 st  through November 30 th , 2016. The patients were randomly assigned to two groups using block randomization. The intervention group received topical sesame oil extracted from tahini (Ardeh) and the placebo group received cooking oil. Pain severity, pain sensitivity and heaviness of painful site were assessed.
Results


Overall, we included 90 patients with traumatic limb injuries in this study who were randomized to two study groups. The mean age of the patients was 28.3 ± 6.8 (ranging from 25 to 35) years and there were 63 (70%) men and 27 (30%) women among the patients. In the sesame oil group, the mean changes in the pain severity (-1.53 ± 0.57, P<0.001), pain sensitivity (-1.45 ± 0.64, P<0.001) and heaviness of painful site (-1.56 ± 0.68, P<0.001) were significantly lower when compared to the placebo group in the second day of the intervention. None of the patients experience adverse drug effects.
Conclusion


Our findings suggest that the topical use of sesame oil extracted from Tahini has a pain reliever effect on the skin after bruising and it helps prevent skin discoloration in patients with traumatic injuries of limbs.",2020,"In the sesame oil group, the mean changes in the pain severity (-1.53 ± 0.57, P<0.001), pain sensitivity (-1.45 ± 0.64, P<0.001) and heaviness of painful site (-1.56 ± 0.68, P<0.001) were significantly lower when compared to the placebo group in the second day of the intervention.","['patients with upper or lower limbs trauma', 'Trauma Patients', '90 patients with traumatic limb injuries', 'mean age of the patients was 28.3 ± 6.8 (ranging from 25 to 35) years and there were 63 (70%) men and 27 (30%) women among the patients', '120 patients with upper or lower trauma in Shahid Rajaee Hospital, Shiraz, Iran, from May', 'patients with traumatic injuries of limbs']","['sesame oil extracted from tahini (Ardeh', 'topical sesame oil extracted from tahini (Ardeh) and the placebo group received cooking oil', 'Topical Sesame Oil Extracted from Tahini ( Ardeh ', 'placebo', 'Placebo']","['Pain Severity', 'heaviness of painful site', 'Pain severity, pain sensitivity and heaviness of painful site', 'pain sensitivity', 'pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0743668', 'cui_str': 'Limb injury'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",90.0,0.390648,"In the sesame oil group, the mean changes in the pain severity (-1.53 ± 0.57, P<0.001), pain sensitivity (-1.45 ± 0.64, P<0.001) and heaviness of painful site (-1.56 ± 0.68, P<0.001) were significantly lower when compared to the placebo group in the second day of the intervention.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Clinical Research Development Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Torabi Davan', 'Affiliation': 'Transplantation Unit, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Intensive Care Unit, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Bolandparvaz', 'Affiliation': 'Trauma Research Center, Department of Surgery, Shahid Rajaee (Emtiaz) Trauma Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'School of Management and Medical Information Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Cognitive Neuroscience, Institute for Cognitive Science Studies, Shahid Beheshti University, Tehran, Iran; Cognitive Science (Brain, Mind, and Education), Shahid Chamran University of Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Chamanpara', 'Affiliation': 'Clinical Research Development Center, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Shayan', 'Affiliation': 'Trauma Research Center, Shahid Rajaee (Emtiaz) Trauma Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Bulletin of emergency and trauma,['10.30476/BEAT.2020.82561']
3088,32944664,Onset times and duration of analgesic effect of various concentrations of local anesthetic solutions in standardized volume used for brachial plexus blocks.,"Visualization of the nerve structures of brachial plexus allows anesthesiologists to use a lower dose of local anesthetics. The content of this low dose is not unequivocal, consequently, the pharmacokinetics of local anesthetics used by various authors are difficult to compare. In this study, the onset times and duration of the analgesic effect of local anesthetic mixture solutions used for brachial plexus blocks are investigated and the quality of anesthesia is compared. 85 unpremedicated American Society of Anesthesiologist physical status I-III, 19-83-year-old patients scheduled for upper limb trauma surgery are assigned to four groups for the axillary-supraclavicular block with lidocaine 1% and bupivacaine 0,5% 1:1 mixture (Group LB) or bupivacaine 0.33% (Group BS) or lidocaine 0,66% (Group LS) or bupivacaine 0.5% and lidocaine 1% 2:1 mixture (Group BL). 0.4 ml/kg was administered to the four groups. The onset time was significantly shorter in the lidocaine group (LS 13.0 ± 1.02) than in the other study groups (LB 16.64 ± 0.89; BS 17.21 ± 0.74; BL 16.92 ± 0.51 min ±SEM, p = 0.002). No differences were observed in the onset times between LB, BS, and BL groups (p > 0.05). Statistical differences were found in the duration of local anesthetics between LB (392.9 ± 20.4), BS (546.4 ± 14.9), LS (172.85 ± 7.8), and BL (458.7 ± 11.9 min ±SEM, p = 0.001). Lidocaine does not shorten the onset times, but significantly decreases the duration of action of bupivacaine when used in mixture solutions. Lidocaine exhibits a good quality of block in the applied dose, while other solutions have excellent quality. Bupivacaine without lidocaine has the longest duration of action to achieve the longest postoperative analgesia.",2020,"No differences were observed in the onset times between LB, BS, and BL groups (p > 0.05).","['85 unpremedicated American Society of Anesthesiologist physical status I-III, 19-83-year-old patients scheduled for upper limb trauma surgery', 'brachial plexus blocks']","['bupivacaine', 'Bupivacaine', 'bupivacaine 0.5% and lidocaine', 'local anesthetic mixture solutions', 'Lidocaine', 'lidocaine 1% and bupivacaine', 'lidocaine']","['onset time', 'duration of local anesthetics', 'duration of action of bupivacaine']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",85.0,0.0185197,"No differences were observed in the onset times between LB, BS, and BL groups (p > 0.05).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Almasi', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Pecs Medical School, 7624, Pécs Ifjuság u.13, Hungary.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rezman', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Pecs Medical School, 7624, Pécs Ifjuság u.13, Hungary.'}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Kriszta', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Pecs Medical School, 7624, Pécs Ifjuság u.13, Hungary.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Patczai', 'Affiliation': 'Department of Traumatology and Hand Surgery, University of Pecs Medical School, 7624, Pécs Ifjuság u.13, Hungary.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Wiegand', 'Affiliation': 'Department of Traumatology and Hand Surgery, University of Pecs Medical School, 7624, Pécs Ifjuság u.13, Hungary.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Bogar', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Pecs Medical School, 7624, Pécs Ifjuság u.13, Hungary.'}]",Heliyon,['10.1016/j.heliyon.2020.e04718']
3089,32944688,Promoting Healthy Family Behaviors in the Primary Care Setting.,"Introduction


Pediatric obesity is an increasingly prevalent problem. Several studies have examined prevention and treatment strategies. The majority of effective studies involved school or community interventions. With health care becoming more collaborative, we hypothesized that a behavioral health specialist may be effective in executing multifaceted interventions with families of at-risk patients.
Methods


This is a prospective randomized study, evaluating impact of intervention with a behavioral specialist on lifestyle risk factors for pediatric obesity in children. At-risk behaviors were identified with a screening tool from the Healthy Kids, Healthy Michigan Clinical Decision Tools, based on the 2007 American Academy of Pediatrics guidelines on pediatric obesity. An intervention group received ongoing care from the behavioral specialist over three months, including motivational interviewing and cognitive behavioral therapy. Participants were compared with a control group receiving usual care.
Results


There was no significant difference between the intervention and control group regarding change in number of risk factors. However, both groups had a reduced number of risk factors at follow-up. The control group had a significant change in number of risk factors after the intervention.
Conclusion


There was no statistically significant difference between the two groups. However, it is notable that both groups saw significant decreases in total number of risk factors. The only addition to usual care provided to the control group was use of the screening tool. Our results indicate that the use of a screening tool and brief physician intervention may be an effective means for improving healthy behaviors within families.",2017,There was no significant difference between the intervention and control group regarding change in number of risk factors.,"['Healthy Kids, Healthy Michigan Clinical Decision Tools, based on the 2007 American Academy of Pediatrics guidelines on pediatric obesity', 'healthy behaviors within families', 'pediatric obesity in children']","['behavioral specialist', 'ongoing care from the behavioral specialist over three months, including motivational interviewing and cognitive behavioral therapy', 'control group receiving usual care']","['total number of risk factors', 'number of risk factors']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.0193179,There was no significant difference between the intervention and control group regarding change in number of risk factors.,"[{'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Weirauch', 'Affiliation': 'Michigan State University, Sparrow Family Medicine Residency Program.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Michigan State University, Sparrow Family Medicine Residency Program.'}]","PRiMER (Leawood, Kan.)",['10.22454/PRiMER.2017.1.2']
3090,32945055,A Secondary Analysis on Effects of Theta Burst Transcranial Magnetic Stimulation to Reduce Anger in Veterans With Posttraumatic Stress Disorder.,"INTRODUCTION


Anger is an important clinical feature of posttraumatic stress disorder (PTSD) that can hamper recovery. We recently reported that intermittent theta burst stimulation (iTBS) demonstrated preliminary efficacy to reduce symptoms of posttraumatic stress disorder and major depression; here, we performed a secondary analysis testing whether iTBS reduced symptoms of anger over the course of iTBS treatment and compared to sham stimulation.
MATERIALS AND METHODS


Fifty veterans with chronic PTSD received ten daily sessions of sham-controlled, double-blind iTBS (1800 pulses/session, once per weekday) targeting the right dorsolateral prefrontal cortex (intent-to-treat = 25 per group). Participants who completed the double-blind phase were offered another ten sessions of unblinded iTBS. Participants completed the Dimensions of Anger Reactions scale at pre-iTBS baseline, treatment midpoints, and endpoints of the blinded and unblinded phases, and at one-month after the last stimulation session. Correlations between anger, PTSD, depression, and sleep were also explored.
RESULTS


After the first week, during the double-blind phase, participants randomized to active stimulation reported significantly reduced anger compared to sham stimulation (p = 0.04). Participants initially randomized to sham appeared to catch-up to the point they no longer differed from those initially randomized to active iTBS when they received iTBS during the unblinded phase (p = 0.14). Anger reduction was maintained at one-month after iTBS in participants initially randomized to active stimulation (i.e., total of four weeks of iTBS).
CONCLUSIONS


This secondary analysis suggests that iTBS might reduce anger in veterans with PTSD. Future studies focused on more granular level anger outcomes and effects of number of stimulation sessions are needed.",2020,"We recently reported that intermittent theta burst stimulation (iTBS) demonstrated preliminary efficacy to reduce symptoms of posttraumatic stress disorder and major depression; here, we performed a secondary analysis testing whether iTBS reduced symptoms of anger over the course of iTBS treatment and compared to sham stimulation.
","['Veterans With Posttraumatic Stress Disorder', 'Fifty veterans with chronic PTSD received ten', 'veterans with PTSD']","['intermittent theta burst stimulation (iTBS', 'Theta Burst Transcranial Magnetic Stimulation', 'daily sessions of sham-controlled, double-blind iTBS', 'iTBS']","['Anger reduction', 'Dimensions of Anger Reactions scale', 'anger, PTSD, depression, and sleep']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0424330', 'cui_str': 'Anger reaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",,0.178188,"We recently reported that intermittent theta burst stimulation (iTBS) demonstrated preliminary efficacy to reduce symptoms of posttraumatic stress disorder and major depression; here, we performed a secondary analysis testing whether iTBS reduced symptoms of anger over the course of iTBS treatment and compared to sham stimulation.
","[{'ForeName': 'Mascha', 'Initials': 'M', 'LastName': ""van 't Wout-Frank"", 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center and Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02906, USA.'}, {'ForeName': 'Mary Tracie', 'Initials': 'MT', 'LastName': 'Shea', 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center and Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02906, USA.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Sorensen', 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center and Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02906, USA.'}, {'ForeName': 'Christiana R', 'Initials': 'CR', 'LastName': 'Faucher', 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center and Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02906, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Greenberg', 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center and Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02906, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center and Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02906, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13256']
3091,32945066,Changes in fecal short-chain fatty acids following fecal microbiota transplantation in patients with irritable bowel syndrome.,"BACKGROUND


Short-chain fatty acids (SCFAs) may play a role in the pathophysiology of irritable bowel syndrome (IBS). This study analyzed fecal SCFAs after performing fecal microbiota transplantation (FMT) in the IBS patients who were included in our previous study of the efficacy of FMT.
METHODS


This study included 142 of the 164 IBS patients who participated in our previous study. They were belonging to three groups: placebo (own feces), 30-g (superdonor feces), and 60-g (superdonor feces) FMT. The patients completed the IBS Severity Scoring System (IBS-SSS) Birmingham IBS Symptom, Fatigue Assessment Scale (FAS), the IBS Quality of Life (IBS-QoL) and Short-Form Nepean Dyspepsia Index (SF-NDI) questionnaires and delivered fecal samples at the baseline and 1 month after FMT. The SCFA levels were determined by vacuum distillation followed by gas chromatography.
KEY RESULTS


The fecal butyric acid level was significantly increased after FMT in both the 30-g and 60-g groups (both P ≤ 0.001). In the 60-g group, the levels of total SCFAs and isobutyric, isovaleric, and valeric acids increased after FMT. Butyric acid levels in the responders in both the 30-g and 60-g FMT groups were significantly inversely correlated with IBS-SSS and FAS scores (P = 0.001, r = -0.3 and P = 0.0001. r=- 0.3, respectively). There were no differences in the SCFA levels in the placebo group after FMT.
CONCLUSION AND INFERENCES


FMT increases the fecal SCFA levels in IBS patients. The increase in the butyric acid level is inversely correlated with symptoms in IBS patients following FMT, suggesting that SCFAs might play a role in the pathophysiology of IBS. www.clini​caltr​ials.gov (NCT03822299).",2020,The fecal butyric acid level was significantly increased after FMT in both the 30-g and 60-g groups (both P ≤ 0.001).,"['patients with irritable bowel syndrome', 'IBS patients', '142 of the 164 IBS patients who participated in our previous study']","['placebo', 'fecal short-chain fatty acids', 'fecal microbiota transplantation (FMT', 'Short-chain fatty acids (SCFAs']","['butyric acid level', 'Birmingham IBS Symptom, Fatigue Assessment Scale (FAS), the IBS Quality of Life (IBS-QoL) and Short-Form Nepean Dyspepsia Index (SF-NDI) questionnaires and delivered fecal samples', 'fecal butyric acid level', 'fecal SCFA levels', 'SCFA levels', 'IBS Severity Scoring System (IBS-SSS', 'IBS-SSS and FAS scores', 'Butyric acid levels', 'levels of total SCFAs and isobutyric, isovaleric, and valeric acids']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}]","[{'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0068263', 'cui_str': 'valeric acid'}]",164.0,0.0426728,The fecal butyric acid level was significantly increased after FMT in both the 30-g and 60-g groups (both P ≤ 0.001).,"[{'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Salhy', 'Affiliation': 'Department of Medicine, Stord Hospital, Stord, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Unger-Vetlesen Institute, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gunnar Hatlebakk', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13983']
3092,32945103,Using Messages Targeting Psychological versus Physical Health Benefits to Promote Walking Behaviour: A Randomised Controlled Trial.,"BACKGROUND


This study aimed to test the efficacy of a messaging intervention targeting psychological or physical benefits plus goal setting and self-monitoring strategies to promote walking activity in the university context.
METHODS


Two hundred and thirty university students from the University of Naples Federico II were randomly allocated to one of four conditions: physical health messages + self-monitoring, psychological health (well-being) messages + self-monitoring, self-monitoring, and no messages. All three intervention conditions were exposed to goal setting (doing at least 7,000 steps a day) and participants were required to monitor their daily progress through the specific step counting app. Participants' walking activity and related psychological variables were assessed at T1 and T2. We ran ANCOVAs and mediation analysis to test our research questions and hypotheses. Analyses were based on the N = 156 who completed all measures at both time points.
RESULTS


Participants in the three experimental (message) conditions reported improvement in psychological variables and behaviour. In particular, the messages focused on the physical health benefits, combined with self-monitoring, were the most effective.
CONCLUSIONS


Our study provides new information on the factors that could be usefully targeted to promote walking activity (i.e. intention, past behaviour, action control, and persuasive messages on the physical benefits of walking).",2020,"RESULTS


Participants in the three experimental (message) conditions reported improvement in psychological variables and behaviour.","['Walking Behaviour', 'Two hundred and thirty university students from the University of Naples Federico II']","['physical health messages\xa0+\xa0self-monitoring, psychological health (well-being) messages\xa0+\xa0self-monitoring, self-monitoring, and no messages']","['walking activity and related psychological variables', 'psychological variables and behaviour']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0476285,"RESULTS


Participants in the three experimental (message) conditions reported improvement in psychological variables and behaviour.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Caso', 'Affiliation': 'University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Carfora', 'Affiliation': 'Catholic University of the Sacred Heart, Milan, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Capasso', 'Affiliation': 'University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Oliano', 'Affiliation': 'University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'University of Leeds, UK.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12224']
3093,32945145,Efficacy of psychological interventions in young individuals at ultra-high risk for psychosis: A naturalistic study.,"AIM


Early detection and intervention in individuals at risk for developing psychosis have become a priority for many clinical services around the world. Limited naturalistic evidence is available on whether detection and intervention for ultra-high risk (UHR) is effective by means of reducing psychosis risk and improving functioning.
METHODS


We compared functioning scores over 5.9 (±7.7) months of time between UHR individuals (n = 61) and help-seeking adolescents without a specific UHR profile (general adolescent help-seeking population [HSP]; n = 82) aged 12 to 25 years receiving psychological interventions at a specialized UHR service in the Netherlands. Attenuated psychotic symptoms (APS) were evaluated over time within the UHR group. In addition, the impact of duration of treatment, <7 sessions, 8 to 21 sessions and >20 sessions, as well as treatment type, that is, cognitive behavioural therapy (CBT) and CBT + add on treatment, were evaluated.
RESULTS


Both UHR and HSP showed an increase in functioning over time (P < .001), with no difference between these groups. The UHR group showed a reduction of APS over time (P < .001). More than 20 treatment sessions was more effective than 1 to 6 treatment sessions (P < .01, partial eta squared = .08) and CBT was equally effective as CBT-add on in improving functioning.
CONCLUSIONS


The findings of this study suggest that psychological treatment is just as effective in improving functioning in UHR as in HSP. Moreover, it decreases APS in UHR. Improvement in functioning is not affected by treatment type, but positively affected by the duration of treatment.",2020,"More than 20 treatment sessions was more effective than 1 to 6 treatment sessions (P < .01, partial eta squared = .08) and CBT was equally effective as CBT-add on in improving functioning.
","['UHR individuals (n = 61) and help-seeking adolescents without a specific UHR profile (general adolescent help-seeking population [HSP]; n = 82) aged 12 to 25\u2009years receiving psychological interventions at a specialized UHR service in the Netherlands', 'individuals at risk for developing psychosis', 'young individuals at ultra-high risk for psychosis']","['CBT', 'psychological interventions']","['functioning over time', 'Attenuated psychotic symptoms (APS', 'reduction of APS over time']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",82.0,0.0324814,"More than 20 treatment sessions was more effective than 1 to 6 treatment sessions (P < .01, partial eta squared = .08) and CBT was equally effective as CBT-add on in improving functioning.
","[{'ForeName': 'Hella', 'Initials': 'H', 'LastName': 'Janssen', 'Affiliation': 'Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Arija', 'Initials': 'A', 'LastName': 'Maat', 'Affiliation': 'Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Margot I E', 'Initials': 'MIE', 'LastName': 'Slot', 'Affiliation': 'Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Floortje', 'Initials': 'F', 'LastName': 'Scheepers', 'Affiliation': 'Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.'}]",Early intervention in psychiatry,['10.1111/eip.13048']
3094,32945150,Efficacy of early initiation of ivabradine treatment in patients with acute heart failure: rationale and design of SHIFT-AHF trial.,"AIMS


Elevated heart rate (HR) in heart failure (HF) is associated with worse outcomes, particularly in acute HF (AHF). HR reduction with ivabradine reduces cardiovascular events in HF patients with reduced ejection fraction. The present trial aimed to test the hypothesis that the early HR reduction using ivabradine improves clinical outcomes in patients with AHF.
METHODS AND RESULTS


SHIFT-AHF is a prospective, multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of ivabradine when adding to standard therapy in AHF patients (SHIFT-AHF). The trial will include 674 AHF patients with left ventricular ejection fraction < 45% and New York Heart Association functional classes III-IV. Participants were enrolled from March 2020 and will be followed up until December 2022. Patients are randomized to treatment with ivabradine or placebo (randomization 1:1). After allocation, the dose of ivabradine is titrated according to HR. Six months' follow-up and three control visits (7, 90, and 180 days after enrolment) are required for every participant. Assessment involves clinical examination, laboratory tests, echocardiography, electrocardiography, heart rhythm, cardiac function, and quality of life. The primary endpoint is a composite of all-cause mortality or re-admission due to worsening HF. Secondary endpoints include the assessments of cardiac remodelling, cardiac functional capacity, and quality of life.
CONCLUSIONS


The SHIFT-AHF trial will shed further light on the role of early HR reduction using ivabradine in patients with AHF.",2020,HR reduction with ivabradine reduces cardiovascular events in HF patients with reduced ejection fraction.,"['heart failure (HF', 'Participants were enrolled from March 2020 and will be followed up until December 2022', 'AHF patients (SHIFT-AHF', 'patients with acute heart failure', '674 AHF patients with left ventricular ejection fraction', 'HF patients with reduced ejection fraction', 'patients with AHF']","['ivabradine or placebo', 'ivabradine', 'placebo', 'ivabradine treatment']","['composite of all-cause mortality or re-admission due to worsening HF', 'assessments of cardiac remodelling, cardiac functional capacity, and quality of life', 'efficacy and safety', 'clinical examination, laboratory tests, echocardiography, electrocardiography, heart rhythm, cardiac function, and quality of life', 'Elevated heart rate (HR', 'cardiovascular events']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",674.0,0.265483,HR reduction with ivabradine reduces cardiovascular events in HF patients with reduced ejection fraction.,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.""}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.""}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Chenhui', 'Initials': 'C', 'LastName': 'Tai', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Nantong University, 6 Northern Haierxiang Road, Nantong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Yangpu Hospital, Tongji University, Shanghai, 20090, China.'}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Qidong People's Hospital, Qidong, Jiangsu, 226200, China.""}, {'ForeName': 'Chunxi', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': ""Department of Cardiology, Qidong People's Hospital, Qidong, Jiangsu, 226200, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.""}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Gee Jun', 'Initials': 'GJ', 'LastName': 'Tye', 'Affiliation': 'Institute for Molecular Medicine Research (INFORMM), Universiti Sains Malaysia (USM), Penang, Malaysia.'}, {'ForeName': 'Sang-Bing', 'Initials': 'SB', 'LastName': 'Ong', 'Affiliation': 'Centre for Cardiovascular Genomics and Medicine (CCGM), Lui Che Woo Institute of Innovative Medicine, Chinese University of Hong Kong (CUHK), Hong Kong.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Heart Failure Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100037, China.'}, {'ForeName': 'Dachun', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.""}]",ESC heart failure,['10.1002/ehf2.12997']
3095,32945153,"Pharmacokinetics, Safety, and Tolerability of Single- and Multiple-Dose Once-Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo-Controlled Study.","The objective of this phase 1 study was to evaluate the pharmacokinetics, safety, and tolerability of baricitinib after single and multiple doses in healthy Chinese adults. Eligible subjects received a once-daily dose of baricitinib 2, 4, or 10 mg or placebo on day 1 (single dose) and days 4 through 10 for 7 consecutive days (multiple doses). Plasma pharmacokinetic samples were collected up to 48 hours after dosing on days 1 and 10, with predose samples collected before dosing on day 1 and days 4 through 10. Safety and tolerability were also assessed. Baricitinib was rapidly absorbed, reaching peak plasma concentrations within 0.5 to 1 hour (median). Plasma concentrations declined rapidly following the attainment of peak concentrations, with a mean terminal half-life of 5.7 to 7.3 hours. Steady-state plasma concentrations of baricitinib were achieved after the second day of once-daily dosing, with minimal accumulation of baricitinib in plasma (up to 10% increase in area under the plasma concentration-time curve). Single- and multiple-dose mean values for area under the plasma concentration-time curve from time zero to infinity and maximum plasma concentration appeared to increase in an approximately dose-proportional manner across the dose range. Single and multiple oral doses of once-daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects.",2020,Single and multiple oral doses of once-daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects.,"['healthy Chinese subjects', 'Healthy Chinese Subjects', 'healthy Chinese adults']","['Single- and Multiple-Dose Once-Daily Baricitinib', 'Placebo', 'baricitinib 2, 4, or 10 mg or placebo']","['Safety and tolerability', 'Pharmacokinetics, Safety, and Tolerability', 'peak plasma concentrations', 'pharmacokinetics, safety, and tolerability of baricitinib', 'Steady-state plasma concentrations of baricitinib', 'Plasma concentrations', 'Plasma pharmacokinetic samples']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0960647,Single and multiple oral doses of once-daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects.,"[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiao Yan', 'Initials': 'XY', 'LastName': 'Sheng', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Payne', 'Affiliation': 'Medical Department, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Medical Department, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.'}, {'ForeName': 'Yi Min', 'Initials': 'YM', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.868']
3096,32945175,Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women.,"PURPOSE


Previous DPP translations in African American women have been suboptimal. This trial evaluated a community-based participatory research developed faith-based diabetes prevention program (DPP) to improve weight loss in African American women.
DESIGN


This cluster randomized trial allocated churches to faith-based (FDPP) or standard (SDPP) DPP interventions. Setting. African American churches. Subjects. Eleven churches with 221 African American women (aged 48.8 ± 11.2 years, BMI = 36.7 ± 8.4) received the FDPP (n = 6) or SDPP (n = 5) intervention.
INTERVENTION


FDPP incorporated 5 faith-based components, including pastor involvement, into the standard DPP curriculum. The SDPP used the standard DPP curriculum. Lay health leaders facilitated interventions at church sites.
MEASURES


Weight and biometrics were collected by blinded staff at baseline, 4- and 10-months.
ANALYSIS


A multilevel hierarchical regression model compared the FDPP and SDPP groups on outcomes.
RESULTS


FDPP and SDPP churches significantly lost weight at 10-months (overall -2.6%, p < .01). Women in FDPP churches who attended at least 15 sessions lost an additional 6.1 pounds at 4-months compared to SDPP corresponding to a 5.8% reduction at 10-months (p < .05). Both groups had significant improvements in health behaviors and biometrics.
CONCLUSIONS


Faith-based and standard DPP interventions led by lay health leaders successfully improved weight, health behaviors, and chronic disease risk. However, the faith-based DPP when fully implemented met the CDC's recommendation for weight loss for diabetes prevention in African American women.",2020,"RESULTS


FDPP and SDPP churches significantly lost weight at 10-months (overall -2.6%, p < .01).","['Eleven churches with 221 African American women (aged 48.8 ± 11.2 years, BMI = 36.7 ± 8.4) received the FDPP (n = 6) or SDPP (n = 5) intervention', 'African American women', 'African American Women', 'African American churches']","['community-based participatory research developed faith-based diabetes prevention program (DPP', 'FDPP and SDPP', 'faith-based (FDPP) or standard (SDPP) DPP interventions', 'Faith-based and standard DPP interventions', 'Faith-Based Diabetes Prevention Program']","['weight loss', 'weight, health behaviors, and chronic disease risk', 'lost weight', 'health behaviors and biometrics', 'Weight and biometrics']","[{'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",11.0,0.0225615,"RESULTS


FDPP and SDPP churches significantly lost weight at 10-months (overall -2.6%, p < .01).","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'Baylor Scott & White Health and Wellness Center, 10616Baylor Scott & White Health, Dallas, TX, USA.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Baylor Scott & White Health and Wellness Center, 10616Baylor Scott & White Health, Dallas, TX, USA.'}, {'ForeName': 'Leilani', 'Initials': 'L', 'LastName': 'Dodgen', 'Affiliation': 'Baylor Scott & White Health and Wellness Center, 10616Baylor Scott & White Health, Dallas, TX, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Slater', 'Affiliation': 'Better Me Within Community Advisory Board, New Millennium Bible Fellowship Praise Center, Dallas, TX, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'King', 'Affiliation': 'Better Me Within Community Advisory Board, New Millennium Bible Fellowship Praise Center, Dallas, TX, USA.'}, {'ForeName': 'Alene', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'Better Me Within Community Advisory Board, New Millennium Bible Fellowship Praise Center, Dallas, TX, USA.'}, {'ForeName': 'J Lee', 'Initials': 'JL', 'LastName': 'Slater', 'Affiliation': 'Better Me Within Community Advisory Board, New Millennium Bible Fellowship Praise Center, Dallas, TX, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'DeHaven', 'Affiliation': 'Department of Public Health Science, 14727University of North Carolina, Charlotte, NC, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120958545']
3097,32945187,Use of Personal Continuous Glucose Monitoring Device Is Associated With Reduced Risk of Hypoglycemia in a 16-Week Clinical Trial of People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion.,"AIMS


Continuous glucose monitoring (CGM) has the potential to promote diabetes self-management at home with a better glycemic control as outcome. Investigation of the effect of CGM has typically been carried out based on randomized controlled trials with prespecified CGM devices on CGM-naïve participants. The aim of this study was to investigate the effect on glycemic control in people using their personal CGM before and during the trial.
MATERIALS AND METHODS


Data from the Onset 5 trial of 472 people with type 1 diabetes using either their personal CGM ( n  = 117) or no CGM ( n  = 355) and continuous subcutaneous insulin infusion in a 16-week treatment period were extracted. Change from baseline in glycated hemoglobin A1c (HbA 1c ), number of hypoglycemic episodes, and CGM metrics at the end of treatment were analyzed with analysis of variance repeated-measures models.
RESULTS


Use of personal CGM compared with no CGM was associated with a reduction in risk of documented symptomatic hypoglycemia (event rate ratio: 0.82; 95% CI: 0.69-0.97) and asymptomatic hypoglycemia (event rate ratio: 0.72; 95% CI: 0.53-0.97), reduced time spent in hypoglycemia ( P  = .0070), and less glycemic variability ( P  = .0043) without a statistically significant increase in HbA 1c  ( P  = .2028).
CONCLUSIONS


Results indicate that use of personal CGM compared with no CGM in a population of type 1 diabetes is associated with a safer glycemic control without a statistically significantly deteriorated effect on HbA 1c , which adds to the evidence about the real-world use of CGM, where device type is not prespecified, and users are not CGM naïve.",2020,"RESULTS


Use of personal CGM compared with no CGM was associated with a reduction in risk of documented symptomatic hypoglycemia (event rate ratio: 0.82; 95% CI: 0.69-0.97) and asymptomatic hypoglycemia (event rate ratio: 0.72; 95% CI: 0.53-0.97), reduced time spent in hypoglycemia ( P  = .0070), and less glycemic variability ( P  = .0043) without a statistically significant increase in HbA 1c  ( P  = .2028).
","['Data from the Onset 5 trial of 472 people with type 1 diabetes using either their personal CGM ( n \u2009=\u2009117) or', 'people using their personal CGM before and during the trial']","['no CGM ( n \u2009=\u2009355) and continuous subcutaneous insulin infusion', 'personal CGM', 'Continuous glucose monitoring (CGM', 'Personal Continuous Glucose Monitoring Device', 'CGM']","['glycated hemoglobin A1c (HbA 1c ), number of hypoglycemic episodes, and CGM metrics', 'time spent in hypoglycemia', 'asymptomatic hypoglycemia', 'HbA 1c', 'Risk of Hypoglycemia', 'glycemic variability', 'risk of documented symptomatic hypoglycemia']","[{'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C3544295', 'cui_str': 'Asymptomatic hypoglycaemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",472.0,0.068112,"RESULTS


Use of personal CGM compared with no CGM was associated with a reduction in risk of documented symptomatic hypoglycemia (event rate ratio: 0.82; 95% CI: 0.69-0.97) and asymptomatic hypoglycemia (event rate ratio: 0.72; 95% CI: 0.53-0.97), reduced time spent in hypoglycemia ( P  = .0070), and less glycemic variability ( P  = .0043) without a statistically significant increase in HbA 1c  ( P  = .2028).
","[{'ForeName': 'Morten Hasselstrøm', 'Initials': 'MH', 'LastName': 'Jensen', 'Affiliation': 'Steno Diabetes Center North Denmark, Aalborg University Hospital, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vestergaard', 'Affiliation': 'Steno Diabetes Center North Denmark, Aalborg University Hospital, Denmark.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hejlesen', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Denmark.'}]",Journal of diabetes science and technology,['10.1177/1932296820957662']
3098,32945207,The Effect of Relative Corneal Refractive Power Shift Distribution on Axial Length Growth in Myopic Children Undergoing Orthokeratology Treatment.,"PURPOSE


To quantify the spatial distribution of relative corneal refractive power shift (RCRPS) to investigate its association with axial length growth.
METHODS


Eighty myopic children were randomly assigned for fitting with type A or B lenses. Axial lengths and corneal topographies were measured at baseline and the 1-, 6-, and 12-months follow-up visits. Treatment-zone decentrations and sizes were derived from tangential maps. RCRPSs were computed by taking the difference between after-treatment and baseline axial maps and then subtracting the apex value. Values at the same radius were averaged to obtain an RCRPS profile, from which four distributional parameters were extracted: the peak value (Rmax), the location where the profile first reached its half peak (X50), and the powers summed within 4- and 8-mm diameter areas (Sum4 and Sum8, respectively). Linear mixed models were used to analyse the correlation between the AL growth and the distributional parameters.
RESULTS


At baseline, no significant differences were observed between the two groups. After treatment, Axial length growth was significantly smaller in subjects fitted with type-B lenses (0.15 ± 0.16 vs 0.25 ± 0.22 mm,  P  = .028). Smaller treatment-zones (1.56 ± 0.14 vs 1.75 ± 0.13 mm,  P  < .01), smaller X50 values (1.56 ± 0.39 vs 1.98 ± 0.28 mm,  P  < .01), and greater Sum4 values (11.83 ± 6.47 vs 8.14 ± 5.06 D,  P  = .01) were also observed in subjects wearing type-B lenses. Among the distributional parameters, only X50 was significantly associated with AL growth in the multiple regression analysis ( P  = .005).
CONCLUSION


The spatial distribution of RCRPS is critical in retarding AL growth, and the ones reaching peak within a shorter distance from the apex may provide better myopia control.",2020,"Smaller treatment-zones (1.56 ± 0.14 vs 1.75 ± 0.13 mm,  P  ","['Myopic Children Undergoing Orthokeratology Treatment', 'Eighty myopic children']",['Relative Corneal Refractive Power Shift Distribution'],"['Axial lengths and corneal topographies', 'smaller X50 values', 'Axial length growth', 'greater Sum4 values']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0429520', 'cui_str': 'Refractive power'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0424639', 'cui_str': 'Height / growth measure'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",80.0,0.0413058,"Smaller treatment-zones (1.56 ± 0.14 vs 1.75 ± 0.13 mm,  P  ","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University , Tianjin, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Bi', 'Affiliation': 'College of Optometry, Nova Southeastern University , Davie, FL, USA.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University , Tianjin, China.'}, {'ForeName': 'Shumao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University , Tianjin, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University , Tianjin, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'College of Optometry, Nova Southeastern University , Davie, FL, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University , Tianjin, China.'}]",Current eye research,['10.1080/02713683.2020.1820528']
3099,32945536,Intravenous Alcohol Administration Selectively Decreases Rate of Change in Elasticity of Demand in Individuals with Alcohol Use Disorder.,"BACKGROUND


Alcohol demand is a key behavioral economic concept that provides an index of alcohol's relative reinforcing value. Initial studies have reported that alcohol demand increases during alcohol administration and in response to alcohol cues. However, the extent to which these effects are observed explicitly in samples composed of individuals with alcohol use disorder and are operative in conjunction with each other has not been studied.
METHODS


To address this gap in the literature, we assessed alcohol demand during an alcohol challenge and subsequent alcohol cue-exposure paradigm in non-treatment seeking, alcohol dependent (i.e., DSM-IV criteria) participants (N = 27). Specifically, participants completed two counterbalanced intravenous, placebo-controlled, alcohol administration sessions followed by a controlled cue-exposure paradigm. At baseline and at breath alcohol concentration (BrAC) of 0.06 g/dl, participants completed the Alcohol Purchase Task (APT), assessing estimated alcohol consumption at escalating prices. Participants were also assessed for alcohol demand following each cue exposure.
RESULTS


During alcohol administration there was a significant decrease in the rate of change in elasticity compared to placebo, and, during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased rate of change in elasticity relative to water cues. There were no statistically significant differences on other demand indices.
CONCLUSIONS


These findings provide further evidence that alcohol administration increases price insensitivity and extends the literature on alcohol's effects on demand by using a clinical sample with alcohol use disorder and by adding a placebo-alcohol condition.",2020,"During alcohol administration there was a significant decrease in the rate of change in elasticity compared to placebo, and, during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased rate of change in elasticity relative to water cues.","['Individuals with Alcohol Use Disorder', 'non-treatment seeking, alcohol dependent (i.e., DSM-IV criteria) participants (N = 27']","['placebo-controlled, alcohol administration sessions followed by a controlled cue-exposure paradigm']","['rate of change in elasticity', 'elasticity relative to water cues', 'Rate of Change in Elasticity of Demand']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",27.0,0.0258914,"During alcohol administration there was a significant decrease in the rate of change in elasticity compared to placebo, and, during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased rate of change in elasticity relative to water cues.","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Nieto', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14460']
3100,32945620,Therapeutic play to teach children with type 1 diabetes insulin self-injection: A pilot trial in a developing country.,"PURPOSE


Child participation in type 1 diabetes (T1D) self-care is needed in developing countries due to a lack of resources, especially during the school day. This pilot study evaluated the feasibility of a therapeutic play intervention (ITP) versus standard education (SE) on the ability of children with T1D to correctly perform insulin injection technique.
DESIGN AND METHODS


Children with T1D (7-12 years) were recruited at two diabetes clinics in Brazil and randomized to ITP or SE. Registered nurses received protocol training to deliver the intervention and perform data collection. ITP group received an education that included a story about a child with T1D who self-injects insulin at school; SE group received routine clinic-based education. Preintervention, children were video-recorded giving insulin injections to a doll; postintervention, children were rerecorded giving the doll an injection. The research team reviewed the videos and assessed the injection technique using validated checklists. Parents reported children's self-injection practices at baseline and 30 days.
RESULTS


Children (N = 20, 40% male) were 9.6 ± 1.3 years old and had T1D for 3.6 ± 2.3 years; HbA1c was 9.1 ± 2.0%; 20% of ITP and 50% of SE children used syringes (vs. pens) for injections. At baseline, 80% of both groups knew how to self-inject; most were taught by a parent/relative. Injection technique scores were low in both groups; ITP group increased their scores significantly postintervention. Practices of self-injection did not change in either group after 30 days.
PRACTICE IMPLICATIONS


The play-based intervention appeared to improve the injection technique in the short-term. Pilot findings support the development of a larger trial to evaluate the effectiveness of ITP on educating children on insulin injections.",2020,Pilot findings support the development of a larger trial to evaluate the effectiveness of ITP on educating children on insulin injections.,"['Children (N\u2009=\u200920, 40% male) were 9.6\u2009±\u20091.3 years old and had T1D for 3.6\u2009±\u20092.3 years; HbA1c was 9.1\u2009±\u20092.0%; 20% of', 'Children with T1D (7-12 years) were recruited at two diabetes clinics in Brazil and randomized to', 'children with T1D to correctly perform insulin injection technique']","['ITP or SE', 'ITP', 'education that included a story about a child with T1D who self-injects insulin at school; SE\xa0group received routine clinic-based education', 'therapeutic play intervention (ITP) versus standard education (SE', 'protocol training']","['Injection technique scores', ""children's self-injection practices""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0021540', 'cui_str': 'Inosine triphosphate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032216', 'cui_str': 'Play therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2960425', 'cui_str': 'Injection technique'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.024626,Pilot findings support the development of a larger trial to evaluate the effectiveness of ITP on educating children on insulin injections.,"[{'ForeName': 'Rebecca O', 'Initials': 'RO', 'LastName': 'La Banca', 'Affiliation': 'Section on Clinical, Behavioral and Outcomes Research, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lori M B', 'Initials': 'LMB', 'LastName': 'Laffel', 'Affiliation': 'Section on Clinical, Behavioral and Outcomes Research, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Volkening', 'Affiliation': 'Section on Clinical, Behavioral and Outcomes Research, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'C Sparapani', 'Affiliation': 'Nursing Department of Federal University of Santa Catarina, Florianopolis, Santa Catarina, Brazil.'}, {'ForeName': 'Emilia C', 'Initials': 'EC', 'LastName': 'de Carvalho', 'Affiliation': 'Ribeirao Preto College of Nursing, PAHO/WHO Collaborating Center for Nursing Research Development, University of São Paulo, Ribeirao Preto, São Paulo, Brazil.'}, {'ForeName': 'Lucila C', 'Initials': 'LC', 'LastName': 'Nascimento', 'Affiliation': 'Ribeirao Preto College of Nursing, PAHO/WHO Collaborating Center for Nursing Research Development, University of São Paulo, Ribeirao Preto, São Paulo, Brazil.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12309']
3101,32945627,Vitamin D supplementation improves anxiety but not depression symptoms in patients with vitamin D deficiency.,"OBJECTIVE


Epidemiological evidence indicated a relationship between vitamin D (VD) and depression with anxiety, but their therapeutic relationship has not been fully elucidated. This study aimed to examine whether VD supplementation would relieve symptoms in patients with depression and anxiety with low serum 25-hydroxy VD [25(OH) D] levels.
METHOD


Participants with low 25(OH)D levels were randomized to control or daily VD group and were followed up for 6 months. Serum concentrations of 25(OH) D were measured using commercial kits. Psychological symptoms were evaluated with the Hamilton Depression Rating Scale-17 (HAMD-17), Revised Social Anhedonia Scale (RSAS), Revised Physical Anhedonia scale (RPAS), and Hamilton Anxiety Rating Scale-14 (HAMA-14). The trial was listed in the trial registration (http://www.medresman.org.cn/uc/index.aspx; NTR number: ChiCTR2000030130).
RESULTS


In this clinical population, no significant difference in depression symptoms was detected between VD group and control group at both baseline and at the endpoint of our study. The HAMD-17, RSAS, and RPAS scores did not change significantly between VD and control groups from baseline to endpoint (all p > .05). However, there was a significant difference in time effect of the total HAMA-14 scores between the two groups (β [95% Cl] = -2.235 [-3.818, -0.653], p = .006).
CONCLUSIONS


Vitamin D supplementation could improve the anxiety symptoms but not depressive symptoms in depressive patients with low VD level after the 6-month intervention.",2020,"The HAMD-17, RSAS, and RPAS scores did not change significantly between VD and control groups from baseline to endpoint (all p > .05).","['Participants with low 25(OH)D levels', 'patients with vitamin D deficiency', 'patients with depression and anxiety with low serum 25-hydroxy VD [25(OH) D']","['VD supplementation', 'vitamin D (VD', 'control or daily VD', 'Vitamin D supplementation']","['Psychological symptoms', 'Hamilton Depression Rating Scale-17 (HAMD-17), Revised Social Anhedonia Scale (RSAS), Revised Physical Anhedonia scale (RPAS), and Hamilton Anxiety Rating Scale-14 (HAMA-14', 'time effect of the total HAMA-14 scores', 'depression symptoms', 'anxiety symptoms', 'HAMD-17, RSAS, and RPAS scores', 'anxiety', 'Serum concentrations of 25(OH']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C3178803', 'cui_str': 'Social Anhedonia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3178804', 'cui_str': 'Physical Anhedonia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0490427,"The HAMD-17, RSAS, and RPAS scores did not change significantly between VD and control groups from baseline to endpoint (all p > .05).","[{'ForeName': 'Cuizhen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yezhe', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jiakuai', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Qingrong', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': 'Department of Maternal, Child & Adolescent Health, School of Public Health, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Dao-Min', 'Initials': 'DM', 'LastName': 'Zhu', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}]",Brain and behavior,['10.1002/brb3.1760']
3102,32948867,"Effects of whey protein and dietary fiber intake on insulin sensitivity, body composition, energy expenditure, blood pressure, and appetite in subjects with abdominal obesity.","BACKGROUND


Recently, we demonstrated that whey protein (WP) combined with low dietary fiber improved lipemia, a risk factor for cardiovascular disease in subjects with abdominal obesity. In the present study, we investigated the effects of intake of WP and dietary fiber from enzyme-treated wheat bran on other metabolic parameters of the metabolic syndrome.
METHODS


The study was a 12-week, double-blind, randomized, controlled, parallel intervention study. We randomized 73 subjects with abdominal obesity to 1 of 4 iso-energetic dietary interventions: 60 g per day of either WP hydrolysate or maltodextrin (MD) combined with high-fiber (HiFi; 30 g dietary fiber/day) or low-fiber (LoFi; 10 g dietary fiber/day) cereal products. We assessed changes in insulin sensitivity, gut hormones (GLP-1, GLP-2, GIP, and peptide YY), body composition, 24-h BP, resting energy expenditure and respiratory exchange ratio (RER), and appetite.
RESULTS


Sixty-five subjects completed the trial. Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02). We found no effects on ratings of satiety, fullness or prospective food consumption for either of the interventions. Intake of WP combined with LoFi increased the postprandial peptide YY response. There were no effects of WP or fiber on insulin sensitivity, body composition, energy expenditure, incretins, or 24-h BP.
CONCLUSIONS


WP consumption for 12 weeks reduced subjective ratings of hunger in subjects with abdominal obesity. Neither WP nor dietary fiber from wheat bran affected insulin sensitivity, 24-h BP, gut hormone responses, body composition, or energy expenditure compared with MD and low dietary fiber.",2020,"Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02).","['subjects with abdominal obesity', 'Sixty-five subjects completed the trial', '73 subjects with abdominal obesity to 1 of 4 iso-energetic dietary interventions']","['WP consumption', 'whey protein (WP) combined with low dietary fiber improved lipemia', 'WP combined with LoFi', 'WP hydrolysate or maltodextrin (MD) combined with high-fiber (HiFi; 30\u2009g dietary fiber/day) or low-fiber (LoFi; 10\u2009g dietary fiber/day) cereal products', 'whey protein and dietary fiber intake', 'WP and dietary fiber from enzyme-treated wheat bran']","['WP or fiber on insulin sensitivity, body composition, energy expenditure, incretins, or 24-h BP', 'postprandial peptide YY response', 'insulin sensitivity, 24-h BP, gut hormone responses, body composition, or energy expenditure', 'insulin sensitivity, gut hormones (GLP-1, GLP-2, GIP, and peptide YY), body composition, 24-h BP, resting energy expenditure and respiratory exchange ratio (RER), and appetite', 'insulin sensitivity, body composition, energy expenditure, blood pressure, and appetite', 'subjective ratings of hunger', 'ratings of satiety, fullness or prospective food consumption', 'Subjective hunger ratings']","[{'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043138', 'cui_str': 'Wheat bran'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",73.0,0.0563907,"Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02).","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Fuglsang-Nielsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark. rasmusfuglsang@gmail.com.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Rakvaag', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Knud Erik Bach', 'Initials': 'KEB', 'LastName': 'Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Gregersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00759-4']
3103,31156170,Associated Factors of Total Costs of Alzheimer's Disease: A Cluster-Randomized Observational Study in China.,"BACKGROUND


Alzheimer's disease (AD) exerts a heavy burden on China. Substantial factors are found associated with high expenditure of AD in high-income countries. To date, few studies have been conducted in China.
OBJECTIVE


This study aimed to analyze the associated factors of the total annual costs of AD in China.
METHODS


Data were drawn from a multi-center, cross-sectional, socioeconomic study on the costs of AD conducted in China from October 2015 to March 2016. Generalized linear model (GLM) using gamma distribution with a log-link function was employed to examine the associated factors of the total cost.
RESULTS


Univariate analysis showed that the demographic and clinical characteristics of AD patients and their caregivers had a substantial impact on the total cost. In GLM analysis, age, monthly household income, AD severity, number of comorbidities, and treatment with memantine were associated with higher expenditure, while the use of a nursing home/care facility was associated with lower expenditure. The mean annual costs for patients with severe dementia were almost twice as high as those for patients with mild dementia (US$ 25,601 versus US$ 13,387, p < 0.001). The mean total cost of AD patients with at least five comorbidities (US$ 38,348) was almost three times than those with no comorbidities (US$ 13,744).
CONCLUSION


In China, AD severity and comorbidities were the most critical factors impacting the total cost. Optimizing care patterns, delaying disease progression, and managing comorbidities comprehensively could decrease the heavy burden of AD.",2019,"The mean annual costs for patients with severe dementia were almost twice as high as those for patients with mild dementia (US$ 25,601 versus US$ 13,387, p < 0.001).","['Data were drawn from a multi-center, cross-sectional, socioeconomic study on the costs of AD conducted in China from October 2015 to March 2016', 'China', ""Alzheimer's disease (AD) exerts a heavy burden on China""]",[],"['total cost', ""Total Costs of Alzheimer's Disease"", 'mean annual costs', 'mean total cost']","[{'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",,0.0528159,"The mean annual costs for patients with severe dementia were almost twice as high as those for patients with mild dementia (US$ 25,601 versus US$ 13,387, p < 0.001).","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fangyu', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shuoqi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Innovation Center for Neurological Disorders, Xuanwu Hospital, Capital Medical University, Beijing, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190166']
3104,31621538,Can Mental Health Anti-stigma Messages Have Untoward Effects on Some People with Depression?: An Exploratory Study.,"Scholars have warned that mental health anti-stigma campaigns targeting the general public can possibly be detrimental to some who are stigmatized. Scholars also have noted that people with depression respond to some public service announcements (PSAs) differently than those without. Accordingly, the current study explored whether anti-stigma PSAs targeting the general public could cause problematic outcomes for people with depression. Participants with ( n  = 55) and without ( n  = 133) heightened depressive symptomatology viewed two mental health anti-stigma PSAs. Participants provided thoughts about the PSAs through a single, open-ended question. To allow for an assessment of convergence, participants rated overall favorability toward each PSA through a close-ended item. Results indicated that most qualitative responses were favorable; however, 23.6% of respondents with heightened depressive symptomatology, compared to 1.5% without, provided responses coded as indicating that at least one PSA caused unintended negative affect, χ 2 (1) = 25.96, [Formula: see text]  p  < .001. Evidence of untoward effects primarily came from the  Friend  PSA and the qualitative responses indicate how this occurred. Moreover, complementing the qualitative coding, the  Friend  PSA was rated less favorably by participants with heightened depressive symptomatology ( M  = 5.00,  SD  = 1.67), than those without ( M  = 5.64,  SD  = 1.44),  F (1, 186) = 6.99,  p  = .009, η p 2  = .036. There were no significant differences in quantitative favorability ratings regarding the  Labeling  PSA. Indicating that further investigation is warranted, results suggest it is possible for an anti-stigma PSA targeting the general public to cause unintended negative affect among some people with depression.",2019,"Moreover, complementing the qualitative coding, the  Friend  PSA was rated less favorably by participants with heightened depressive symptomatology ( M  = 5.00,  SD  = 1.67), than those without ( M  = 5.64,  SD  = 1.44),  F (1, 186) = 6.99,  p  = .009, η p 2  = .036.","['people with depression', 'Participants with ( n  =\xa055) and without ( n  =\xa0133) heightened depressive symptomatology viewed two mental health anti-stigma PSAs']",[],"['quantitative favorability ratings', 'heightened depressive symptomatology']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0687688', 'cui_str': 'Public Service Announcements'}]",[],"[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}]",,0.103578,"Moreover, complementing the qualitative coding, the  Friend  PSA was rated less favorably by participants with heightened depressive symptomatology ( M  = 5.00,  SD  = 1.67), than those without ( M  = 5.64,  SD  = 1.44),  F (1, 186) = 6.99,  p  = .009, η p 2  = .036.","[{'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Division of Behavioral & Organizational Sciences, Claremont Graduate University, Claremont, CA, USA.'}, {'ForeName': 'Elidé', 'Initials': 'E', 'LastName': 'Flores-Medel', 'Affiliation': 'Division of Behavioral & Organizational Sciences, Claremont Graduate University, Claremont, CA, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Martinez', 'Affiliation': 'Division of Behavioral & Organizational Sciences, Claremont Graduate University, Claremont, CA, USA.'}, {'ForeName': 'Dale E', 'Initials': 'DE', 'LastName': 'Berger', 'Affiliation': 'Division of Behavioral & Organizational Sciences, Claremont Graduate University, Claremont, CA, USA.'}]",Journal of health communication,['10.1080/10810730.2019.1672838']
3105,32945234,Clinical implications of transversus abdominis plane block (TAP-block) for robot assisted laparoscopic radical prostatectomy: A single-institute analysis.,"INTRODUCTION


The aim of this study was to evaluate the role of TAP block in improvement of anesthesiological management and perioperative surgical outcomes of robot-assisted laparoscopic radical prostatectomy (RALP).
METHODS


We consecutive enrolled 93 patients with prostate cancer whose underwent RALP at our department from January 2019 to December 2019. Group A included 45 patients who received bilateral TAP block, and Group B included 48 patients who did not received TAP block. TAP blocks were always performed by a single anesthesia team. An elastomeric pump device was used in all patients for post-operative pain management. TAP block was performed according to Rafi's technique, with Ropivacaine 0.375% and dexamethasone 4 mg. Mean values with standard deviations (±SD) were computed and reported for all items. Statistical significance was achieved if  p -value was ⩽0.05 (two-sides).
RESULTS


The two groups showed no difference in the most important demographics and baseline characteristics ( p  > 0.05). Group A showed a significant longer time of anaesthesia. Moreover, Ketorolac doses (started dose plus continuous post-operative infusion via elastomeric pump) used in Group A were significantly lower than Group B. Despite this, Group B showed statistical significant higher value of NRS PACU and at 12, 24, 48, 72 h than Group A but not at 96 h. Rescue analgesic medication use was significantly higher in the Group B than Group A. Moreover, patency of the intestinal tract and time to ambulation was significantly lower in the Group A.
DISCUSSION


The use of TAP block during a RALP is a safe procedure that can be applied more appropriately to achieve better pain control. A multimodal protocol that includes locoregional anesthesia, reduction of intra and postoperative use of strong opiates, correct placing of the patient and the use of low pneumoperitoneum pressures should be implemented in order to reach a faster and better post-operative full recovery of patients whose underwent RALP.",2020,Group A showed a significant longer time of anaesthesia.,"['45 patients who received', '93 patients with prostate cancer whose underwent RALP at our department from January 2019 to December 2019']","['laparoscopic radical prostatectomy', 'robot-assisted laparoscopic radical prostatectomy (RALP', 'transversus abdominis plane block (TAP-block', 'bilateral TAP block', 'TAP block', 'Ropivacaine 0.375% and dexamethasone', 'Ketorolac']","['analgesic medication use', 'Mean values with standard deviations (±SD', 'longer time of anaesthesia', 'patency of the intestinal tract and time to ambulation', 'NRS PACU']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]",93.0,0.0423446,Group A showed a significant longer time of anaesthesia.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Chiancone', 'Affiliation': 'Urology Department, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fabiano', 'Affiliation': 'Urology Department, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ferraiuolo', 'Affiliation': 'Department of Anesthesiology, TIPO e OTI, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'de Rosa', 'Affiliation': 'Department of Anesthesiology, TIPO e OTI, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Prisco', 'Affiliation': 'Department of Anesthesiology, TIPO e OTI, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fedelini', 'Affiliation': 'Urology Department, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Meccariello', 'Affiliation': 'Urology Department, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Visciola', 'Affiliation': 'General and Specialized Surgery for Women and Children, University of Campania Luigi Vanvitelli, Caserta, Campania, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fedelini', 'Affiliation': 'Urology Department, Antonio Cardarelli Hospital, Naples, Italy.'}]",Urologia,['10.1177/0391560320957226']
3106,32945261,A Mobile Social Network-Based Smoking Cessation Intervention for Chinese Male Smokers: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.
OBJECTIVE


This paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.
METHODS


A two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).
RESULTS


Recruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).
CONCLUSIONS


If the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/18071.",2020,"Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users.","['Chinese Male', '80 eligible individuals who had gone through the required registration process were registered as participants of the trial', 'Chinese male smokers to quit smoking', 'Chinese Male Smokers', 'Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men']","['Mobile Social Network-Based Smoking Cessation Intervention', 'SCAMPI program', 'social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App', 'Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users', 'SCAMPI program (placebo app', 'SCAMPI']","[""participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence"", '30-day smoking abstinence', '30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test', ""participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire""]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0757957,"Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users.","[{'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tingzhong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Centre for Tobacco Control Research, School of Medicine, The Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'The National Institute for Health Innovation, The University of Auckland, Auckland, New Zealand.'}]",JMIR research protocols,['10.2196/18071']
3107,32945632,Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.,"BACKGROUND


Platinum-based chemotherapy is standard-of-care first-line treatment for advanced urothelial carcinoma. However, progression-free survival and overall survival are limited by chemotherapy resistance.
METHODS


In a phase 3 trial, we randomly assigned patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of gemcitabine plus cisplatin or carboplatin) to receive best supportive care with or without maintenance avelumab. The primary end point was overall survival, assessed among all patients who underwent randomization (overall population) and among those with tumors positive for programmed cell death ligand 1 (PD-L1). Secondary end points included progression-free survival and safety.
RESULTS


Among all 700 patients who underwent randomization, the addition of maintenance avelumab to best supportive care significantly prolonged overall survival as compared with best supportive care alone (control). Overall survival at 1 year was 71.3% in the avelumab group and 58.4% in the control group (median overall survival, 21.4 months vs. 14.3 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.86; P = 0.001). Avelumab also significantly prolonged overall survival in the PD-L1-positive population; overall survival at 1 year was 79.1% in the avelumab group and 60.4% in the control group (hazard ratio, 0.56; 95% CI, 0.40 to 0.79; P<0.001). The median progression-free survival was 3.7 months in the avelumab group and 2.0 months in the control group in the overall population (hazard ratio for disease progression or death, 0.62; 95% CI, 0.52 to 0.75) and 5.7 months and 2.1 months, respectively, in the PD-L1-positive population (hazard ratio, 0.56; 95% CI, 0.43 to 0.73). The incidence of adverse events from any cause was 98.0% in the avelumab group and 77.7% in the control group; the incidence of adverse events of grade 3 or higher was 47.4% and 25.2%, respectively.
CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Bladder 100 ClinicalTrials.gov number, NCT02603432.).",2020,"CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.","['patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of', 'patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy', 'Advanced or Metastatic Urothelial Carcinoma', 'advanced urothelial carcinoma']","['Avelumab Maintenance Therapy', 'supportive care with or without maintenance avelumab', 'gemcitabine plus cisplatin or carboplatin', 'Platinum-based chemotherapy']","['progression-free survival and safety', 'Overall survival', 'incidence of adverse events', 'median progression-free survival', 'progression-free survival and overall survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",700.0,0.381542,"CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Voog', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caserta', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Begoña P', 'Initials': 'BP', 'LastName': 'Valderrama', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Haralabos', 'Initials': 'H', 'LastName': 'Kalofonos', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Siniša', 'Initials': 'S', 'LastName': 'Radulović', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Demey', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ullén', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Srikala S', 'Initials': 'SS', 'LastName': 'Sridhar', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Tsuchiya', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kopyltsov', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Jeanny B', 'Initials': 'JB', 'LastName': 'Aragon-Ching', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Laliberte', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fowst', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Costa', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Blake-Haskins', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Grivas', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}]",The New England journal of medicine,['10.1056/NEJMoa2002788']
3108,32945733,Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?,"BACKGROUND


Unplanned cesarean birth is associated with high levels of patient dissatisfaction and negative birth experiences, which in turn can negatively impact birth outcomes. Previous research has demonstrated that issues of physician-patient communication, mistrust, fear of the operating room (OR), and loss of control contribute to patient dissatisfaction with unplanned cesarean birth. We hypothesized that altering the nature and structure of the informed consent prior to the surgery might improve patient satisfaction and birth experience. Specifically, we explored whether educating resident physicians in counseling skills could shift the focus of informed consent from a checklist merely informing the patient of the risks, benefits, and alternatives to a discussion that informs the physician of the patient's concerns and fears. By approaching consent in this manner, the goal of informed consent expands beyond autonomy rights to include beneficence as well.  Methods:  Residents received education to discuss issues of communication, fear, mistrust, and loss of control when seeking consent for an unplanned cesarean birth. Patients were randomized to receive either additional counseling that encouraged a discussion or a standard informed consent for cesarean birth. Participants were interviewed two weeks later and scored their satisfaction using a Likert scale on the four themes: communication, mistrust, fear of OR, and loss of control.  Results:  Both groups had very high patient satisfaction scores; there was no statistical difference between them.  Conclusions:  Both groups exhibited significantly higher levels of birth satisfaction than present in prior research. Training residents to discuss these issues while seeking consent for an unplanned cesarean birth may have improved patient satisfaction for all participants in this study. This suggests that educating residents to engage patients in a dialogue during informed consent counseling is more important than a specific script.",2020,Both groups had very high patient satisfaction scores; there was no statistical difference between them.  ,[],['additional counseling that encouraged a discussion or a standard informed consent for cesarean birth'],"['birth satisfaction', 'Unplanned Cesarean Birth']",[],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",,0.0198502,Both groups had very high patient satisfaction scores; there was no statistical difference between them.  ,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burcher', 'Affiliation': 'Department of Obstetrics and Gynecology, WellSpan York Hospital, York, Pennsylvania, USA.'}, {'ForeName': 'Shazneen', 'Initials': 'S', 'LastName': 'Hushmendy', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Chan-Mahon', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Dasani', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Jazmine', 'Initials': 'J', 'LastName': 'Gabriel', 'Affiliation': 'Penn State Health, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Crosby', 'Affiliation': 'Department of Obstetrics and Gynecology, Albany Medical College, Albany, New York, USA.'}]",AJOB empirical bioethics,['10.1080/23294515.2020.1817174']
3109,32945735,"Efficacy of Daily Intake of Dried Cranberry 500 mg in Women with Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Study.","PURPOSE


To determine the efficacy of dried cranberry on reducing symptoms of overactive bladder in women.
MATERIALS AND METHODS


Eligible women aged 18 or older with overactive bladder were randomized to either daily dried cranberry powder (500mg) or placebo (500mg) and followed for 24-weeks. Efficacy was measured by 3-day voiding diaries and Overactive Bladder Questionnaire Short Form, Patient Perception of Bladder Condition, Sexual Quality of Life-Female, and Pelvic Floor Distress Inventory surveys. Statistical analyses were performed by BIOFORTIS using SAS® software version 9.4.
RESULTS


Of the 98 women who were randomized, 77 completed all the visits, and 60 were included in the per protocol analysis. Compared to placebo, using per-protocol analysis, the cranberry group showed a significant reduction of daily micturitions (-1.91, 95%CI: -3.74, -0.88, P = 0.0406), urgency episodes (-2.81, 95%CI: -4.82, -0.80, P = 0.0069), and Patient Perception of Bladder Condition scores (-0.66, 95%CI: -1.23, 0.08, P = 0.0258) at 24-weeks of follow-up. Mean volume per micturition, nocturia, and the remaining survey outcomes did not differ significantly between the two groups (P > 0.05).
CONCLUSIONS


Daily intake of dried cranberry powder reduced daily micturition by 16.4%, urgency episodes by 57.3%, and patient perception of bladder condition by 39.7%. However, an intent-to-treat analysis showed no statistically significant difference between the groups for these measurements (p>0.05). Future larger studies with longer follow-up periods are needed to further determine the long-term effect of cranberry on overactive bladder.",2020,"Mean volume per micturition, nocturia, and the remaining survey outcomes did not differ significantly between the two groups (P > 0.05).
","['women', 'Eligible women aged 18 or older with overactive bladder', 'Women with Overactive Bladder', '98 women who were randomized']","['Dried Cranberry', 'dried cranberry', '95%CI', 'placebo', 'daily dried cranberry powder', 'Placebo', 'cranberry']","['daily micturitions', 'Mean volume per micturition, nocturia, and the remaining survey outcomes', 'daily micturition', 'urgency episodes', 'patient perception of bladder condition', 'Efficacy', 'Patient Perception of Bladder Condition scores', '3-day voiding diaries and Overactive Bladder Questionnaire Short Form, Patient Perception of Bladder Condition, Sexual Quality of Life-Female, and Pelvic Floor Distress Inventory surveys']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",,0.476572,"Mean volume per micturition, nocturia, and the remaining survey outcomes did not differ significantly between the two groups (P > 0.05).
","[{'ForeName': 'Ahra', 'Initials': 'A', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Weill Cornell Medical College-New York Presbyterian Hospital, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eidelberg', 'Affiliation': 'Department of Urology, Weill Cornell Medical College-New York Presbyterian Hospital, New York.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Butler', 'Affiliation': 'Tri-Institutional Computational Biol. & Medicine Program, Weill Cornell Medicine, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Danko', 'Affiliation': 'Tri-Institutional Computational Biol. & Medicine Program, Weill Cornell Medicine, New York.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Afshinnekoo', 'Affiliation': 'Tri-Institutional Computational Biol. & Medicine Program, Weill Cornell Medicine, New York.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Mason', 'Affiliation': 'Tri-Institutional Computational Biol. & Medicine Program, Weill Cornell Medicine, New York.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Chughtai', 'Affiliation': 'Department of Urology, Weill Cornell Medical College-New York Presbyterian Hospital, New York.'}]",The Journal of urology,['10.1097/JU.0000000000001384']
3110,32945775,Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial.,"BACKGROUND


The role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied.
OBJECTIVE


We evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects.
METHODS


This study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n=31) maintained their previous diabetes management strategies. Participants in the intervention group (n=41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA 1c ) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group.
RESULTS


A total of 66 participants completed this study. HbA 1c  (P=.04), total cholesterol level (P=.04), and Problem Areas in Diabetes scores (P=.02) significantly decreased; total diet (P=.03) and self-monitoring of blood glucose level scores (P=.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements.
CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03468283; http://clinicaltrials.gov/ct2/show/NCT03468283.",2020,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","['6 months at Kangbuk Samsung Hospital', 'Participants in the control group (n=31) maintained their previous diabetes management strategies', 'Diabetes Management', '66 participants completed this study']","['Voluntary Participation', 'mHealth-based diabetes self-management education', 'mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals']","['Mobile Health Care', 'total cholesterol level', 'Diabetes scores', 'glycated hemoglobin (HbA 1c ) level', 'self-monitoring of blood glucose level scores', 'Diabetes Self-Care Activities Questionnaire', 'changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",66.0,0.0783678,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","[{'ForeName': 'Da Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hyun', 'Initials': 'SH', 'LastName': 'Yoo', 'Affiliation': 'Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyong Pil', 'Initials': 'KP', 'LastName': 'Min', 'Affiliation': 'Huraypositive Inc, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/19153']
3111,32946700,"Gender, having a positive FIT and type of hospital are important factors for colonoscopy experience in colorectal cancer screening - findings from the SCREESCO study.","OBJECTIVES


Assessing the experience of screening procedures is crucial for improving the quality and acceptance of colonoscopy in colorectal cancer screening. The aim of the study was to investigate the colonoscopy experience and associated factors among individuals who underwent a colonoscopy in the Screening of Swedish Colons (SCREESCO) study.
METHODS


Participants in the Screening of Swedish Colons (SCREESCO;  n  = 7593) randomized clinical trial (colonoscopy vs. faecal immunochemical test (FIT)) were enrolled. The primary outcome was overall colonoscopy experience measured with a study-specific questionnaire. Secondary endpoints were measured using multiple regression analyses with factors that included sex, randomization group, geographical regions, university hospital, complications, sedation, clean bowel, time to cecum, and presence of polyps or cancer.
RESULTS


A total of 6572 (87%) individuals responded to the questionnaire. The majority was satisfied with the information, care and treatment. Women reported more worry, discomfort and pain, but also better information, care and treatment compared with men. The FIT group was more worried and perceived more discomfort and pain than the colonoscopy group. Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
CONCLUSIONS


Although most participants were satisfied with the colonoscopy experience, the study has highlighted areas for improvement. Important factors for colonoscopy experience were gender, randomization group, and type of hospital and therefore crucial to bear in mind when designing screening programs.",2020,"Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
","['A total of 6572 (87%) individuals responded to the questionnaire', 'Type of hospital (geographical region; university hospital vs. not university hospital', 'Participants in the Screening of Swedish Colons (SCREESCO;  n \u2009=\u20097593) randomized clinical trial (colonoscopy vs. faecal immunochemical test (FIT)) were enrolled', 'individuals who underwent a colonoscopy in the Screening of Swedish Colons (SCREESCO) study']",[],"['overall colonoscopy experience measured with a study-specific questionnaire', 'discomfort and pain', 'geographical regions, university hospital, complications, sedation, clean bowel, time to cecum, and presence of polyps or cancer', 'worry, discomfort and pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",7593.0,0.0690388,"Type of hospital (geographical region; university hospital vs. not university hospital) was also a significant predictor for the colonoscopy experience.
","[{'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Fritzell', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsberg', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wangmar', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Division of Biostatics, Institution of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Hultcrantz', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Sweden.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1820568']
3112,32946702,Mandibular Advancement Device Treatment Efficacy is Associated with Polysomnographic Endotypes.,"RATIONALE


Mandibular advancement device (MAD) treatment efficacy varies among obstructive sleep apnea (OSA) patients.
OBJECTIVES


The current study aims to explain underlying individual differences in efficacy using OSA endotypic traits calculated from baseline clinical polysomnography: collapsibility (airflow at normal ventilatory drive, Vpassive), loop gain (drive response to reduced airflow), arousal threshold (drive preceding arousal), compensation (increase in airflow as drive increases) and the ventilatory response to arousal (VRA, increase in drive explained by arousal). Based on previous research, we hypothesized that responders to MAD treatment have a lower loop gain and milder collapsibility.
METHODS


Thirty-six patients (apnea-hypopnea index [AHI] 23.5[IQR:19.7-29.8]/h) underwent baseline and 3-month follow-up full polysomnography, with MAD fixed at 75% of maximal protrusion. Traits were estimated using baseline polysomnography according to Sands et al. (AJRCCM 2018). Response was defined as AHI reduction ≥ 50%.
RESULTS


MAD treatment significantly reduced AHI (49.7%[23.9-63.6] of baseline, median[IQR]). Responders exhibited lower loop gain (mean[95%CI], 0.53[0.48-0.58] vs. 0.65[0.57-0.73]; p=0.020) at baseline compared to non-responders, a difference that persisted after adjustment for baseline AHI and BMI. Elevated loop gain remained associated with non-response after adjustment for collapsibility (OR: 3.03 [1.16 - 7.88] per 1 SD increase in loop gain [SD=0.15]; p=0.023).
CONCLUSIONS


MAD non-responders exhibit greater ventilatory instability, expressed as higher loop gain. Assessment of the baseline degree of ventilatory instability using this approach may improve upfront MAD treatment patient selection.
CLINICAL TRIAL REGISTRATION


The current study is a secondary analysis of the parent clinical trial NCT01532050 (Clinicaltrial.gov).",2020,"RESULTS


MAD treatment significantly reduced AHI (49.7%[23.9-63.6] of baseline, median[IQR]).","['Thirty-six patients (apnea-hypopnea index', 'obstructive sleep apnea (OSA) patients']",[],['Elevated loop gain'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445022', 'cui_str': 'Loop'}]",,0.279553,"RESULTS


MAD treatment significantly reduced AHI (49.7%[23.9-63.6] of baseline, median[IQR]).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Op de Beeck', 'Affiliation': 'University of Antwerp Faculty of Medicine and Health Sciences, 81844, Wilrijk, Belgium.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Dieltjens', 'Affiliation': 'University of Antwerp Faculty of Medicine and Health Sciences, 81844, Wilrijk, Belgium.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Azarbarzin', 'Affiliation': ""Brigham and Women's Hospital, 1861, Division of sleep and Circadian Disorders, Boston, Massachusetts, United States.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Willemen', 'Affiliation': 'University Hospital Antwerp, 60202, Multidisciplinary Sleep Disorders Centre, Edegem, Antwerp, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Verbraecken', 'Affiliation': 'University of Antwerp Faculty of Medicine and Health Sciences, 81844, Wilrijk, Belgium.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Braem', 'Affiliation': 'University Hospital Antwerp, 60202, Special Dentistry Care, Edegem, Antwerp, Belgium.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wellman', 'Affiliation': ""Brigham and Women's Hospital, 1861, Division of Sleep and Circadian Disorders, Boston, Massachusetts, United States.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Brigham and Women's Hospital, 1861, Division of Sleep and Circadian Disorders, Boston, Massachusetts, United States.""}, {'ForeName': 'Olivier M', 'Initials': 'OM', 'LastName': 'Vanderveken', 'Affiliation': 'University Hospital Antwerp, 60202, ENT, Head and Neck Surgery, Edegem, Antwerp, Belgium.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202003-220OC']
3113,31571392,Limited sampling strategy to predict the area under the curve of tacrolimus in Mexican renal transplant pediatric patients receiving Prograf ®  or non-innovator formulations.,"TDM of tacrolimus is usually performed with trough levels (C 0h  ). However, in pediatric patients, C 0h  may not be an adequate marker. The AUC is considered a more suitable indicator of drug exposure. As several blood samples are needed for the estimation of AUC, and LSS for predicting tacrolimus AUC and optimizing the dose adjustment have been proposed. Moreover, in emerging countries such as Mexico, non-innovator formulations, which bioequivalence has not been demonstrated, are frequently used. Hence, the aim of this study was to develop and validate a LSS to predict the tacrolimus AUC 0-12h  in Mexican pediatric kidney transplant recipients who received either Prograf ®  or non-innovator tacrolimus formulations. A total of 56 pharmacokinetic profiles were randomized into two groups: model development (n = 28) and model validation (n = 28). The limited sampling equations were obtained after a stepwise multiple regression using AUC as the dependent variable and tacrolimus blood concentrations, quantified by CMIA, at different time points as the independent variables. The final equation included observed concentrations at 1 hour (C 1h  ) and 4 hours (C 4h  ) after dose administration. The predictive performance of the model was adequate in terms of both, bias and precision. Results strongly suggest that the clinical use of this LSS could provide an ethical, cost-, and time-effective method in the TDM of tacrolimus in pediatric patients with kidney transplant. The model proved to be adequate with either Prograf ®  or non-innovator tacrolimus formulations of dubious bioequivalence.",2019,The model proved to be adequate with either Prograf ®  or non-innovator tacrolimus formulations of dubious bioequivalence.,"['A total of 56 pharmacokinetic profiles', 'pediatric patients with kidney transplant', 'Mexican renal transplant pediatric patients receiving Prograf ®  or non-innovator formulations', 'Mexican pediatric kidney transplant recipients who received either Prograf ®  or non-innovator tacrolimus formulations']",['TDM of tacrolimus'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0678125', 'cui_str': 'Prograft'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",[],56.0,0.0361991,The model proved to be adequate with either Prograf ®  or non-innovator tacrolimus formulations of dubious bioequivalence.,"[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Medina-Aymerich', 'Affiliation': 'Departamento de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Ciudad de México, Mexico.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'González-Ramírez', 'Affiliation': 'Departamento de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Ciudad de México, Mexico.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'García-Roca', 'Affiliation': 'Unidad de Investigación y Diagnóstico en Nefrología y Metabolismo Mineral Óseo, Hospital Infantil de México Federico Gómez, Ciudad de México, Mexico.'}, {'ForeName': 'Herlinda', 'Initials': 'H', 'LastName': 'Reyes', 'Affiliation': 'Laboratorio Central, Hospital Infantil de México Federico Gómez, Ciudad de México, Mexico.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Hernández', 'Affiliation': 'Unidad de Investigación y Diagnóstico en Nefrología y Metabolismo Mineral Óseo, Hospital Infantil de México Federico Gómez, Ciudad de México, Mexico.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Medeiros', 'Affiliation': 'Unidad de Investigación y Diagnóstico en Nefrología y Metabolismo Mineral Óseo, Hospital Infantil de México Federico Gómez, Ciudad de México, Mexico.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Castañeda-Hernández', 'Affiliation': 'Departamento de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Ciudad de México, Mexico.'}]",Pediatric transplantation,['10.1111/petr.13595']
3114,31661733,[Impact of skin-to-skin contact at birth on exclusive breastfeeding and the regulation of vital signs].,,2019,,[],['skin-to-skin contact'],[],[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",[],,0.0195981,,"[{'ForeName': 'Brenda Sagrario', 'Initials': 'BS', 'LastName': 'Rosas-Herrera', 'Affiliation': 'Tecnológico de Monterrey. Nuevo León, México.'}, {'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Rodríguez-de Ita', 'Affiliation': 'Tecnológico de Monterrey. Nuevo León, México.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Martínez-Cardona', 'Affiliation': 'Multicéntricos de Especialidades Médicas, Tecnológico de Monterrey. Nuevo León, México.'}]",Salud publica de Mexico,['10.21149/10477']
3115,31735729,Efficacy and Reproducibility of Attenuation-Compensated Optical Coherence Tomography for Assessing External Elastic Membrane Border and Plaque Composition in Native and Stented Segments　- An In Vivo and Histology-Based Study.,"BACKGROUND


Attenuation-compensated (AC) technique was recently introduced to improve the plaque characterization of optical coherence tomography (OCT). Histological validation demonstrated promising results but the efficacy and reproducibility of this technique for assessing in-vivo tissue composition remains unclear.Methods and Results:OCT images portraying native (n=200) and stented (n=200) segments and 31 histological cross-sections were analyzed. AC-OCT appeared superior to conventional (C)-OCT in detecting the external elastic lamina (EEM) borders (76% vs. 65.5%); AC-OCT enabled larger EEM arc detection compared with C-OCT (174.2±58.7° vs. 137.5±57.9°; P<0.001). There was poor agreement between the 2 techniques for detection of lipid in native and lipid and calcific tissue in stented segments (κ range: 0.164-0.466) but the agreement of C-OCT and AC-OCT was high for calcific tissue in native segments (κ=0.825). Intra and interobserver agreement of the 2 analysts was moderate to excellent with C-OCT (κ range: 0.681-0.979) and AC-OCT (κ range: 0.733-0.892) for all tissue types in both native and stented segments. Ex-vivoanalysis demonstrated that C-OCT was superior to AC-OCT (κ=0.545 vs. κ=0.296) for the detection of the lipid component in native segments.
CONCLUSIONS


The AC technique allows better delineation of the EEM but it remains inferior for lipid pool detection and neointima characterization. Combined AC- and C-OCT imaging may provide additional value for complete assessment of plaque and neointima characteristics.",2019,The AC technique allows better delineation of the EEM but it remains inferior for lipid pool detection and neointima characterization.,[],"['Attenuation-compensated (AC) technique', 'Compensated Optical Coherence Tomography', 'Combined AC- and C-OCT imaging']","['detection of lipid in native and lipid and calcific tissue', 'Efficacy and Reproducibility of Attenuation']",[],"[{'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0307033,The AC technique allows better delineation of the EEM but it remains inferior for lipid pool detection and neointima characterization.,"[{'ForeName': 'Anantharaman', 'Initials': 'A', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}, {'ForeName': 'Jaryl', 'Initials': 'J', 'LastName': 'Ng', 'Affiliation': 'Department of Biomedical Engineering, National University of Singapore.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Department of Life Sciences, Manchester Metropolitan University.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Johnson', 'Affiliation': 'Department of Cardiology, Bristol Royal Infirmary.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Foin', 'Affiliation': 'Department of Biomedical Engineering, National University of Singapore.'}, {'ForeName': 'Michael J A', 'Initials': 'MJA', 'LastName': 'Girard', 'Affiliation': 'Department of Biomedical Engineering, National University of Singapore.'}, {'ForeName': 'Jouke', 'Initials': 'J', 'LastName': 'Dijkstra', 'Affiliation': 'Division of Image Processing, Department of Radiology, Leiden University Medical Center.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Amersey', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Scoltock', 'Affiliation': 'School of Clinical Sciences, University of Bristol.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Koganti', 'Affiliation': 'Citizens Specialty Hospital.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}, {'ForeName': 'Chongying', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, University of Bern.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Faculty of Medicine, National Heart & Lung Institute, Imperial College London.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Torii', 'Affiliation': 'Department of Mechanical Engineering, University College London.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crake', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}, {'ForeName': 'Roby', 'Initials': 'R', 'LastName': 'Rakhit', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}, {'ForeName': 'Christos V', 'Initials': 'CV', 'LastName': 'Bourantas', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0630']
3116,32941094,Influence of Surface Conditioning on the Repair Strength of Bioactive Restorative Material.,"OBJECTIVE


To evaluate the effects of surface treatment and repair material on the repair shear bond strength (SBS) of the bioactive restorative material.
METHODS


A total of 240 Activa BioActive Restorative (Activa) discs were prepared, aged, and polished, and divided randomly into eight groups ( n  = 30). Groups 1-4 discs were repaired with bulk-fill flowable resin-based composite (Bulk-RBC), and Groups 5-8 discs with Activa. Surface treatment used for each repair material type were air abrasion with silica-coated 30-m Al 2 O 3  particles (air abrasion) (Groups 2 & 6), Air abrasion with universal primer (Groups 3 & 7), and Air abrasion with universal adhesive (Groups 4 & 8). Groups 1 and 5 were controls without surface treatment. SBS test was performed, and the failure mode and surface topography were assessed.
RESULTS


Surface treatment with air abrasion significantly improved the SBS for repair using both Activa and Bulk-RBC. Repair SBS using Activa was significantly higher compared with Bulk-RBC. Cohesive failure in substrate and mixed failures were most common in the surface-treated groups (2-4, 6-8). Air abrasion produced prominent surface topography changes compared with polishing.
CONCLUSION


Air abrasion enhances the repair SBS of aged bioactive restorative material. The use of the same material (Activa) for repair affords a higher bond strength compared with the use bulk-RBC.",2020,"Air abrasion produced prominent surface topography changes compared with polishing.
","['A total of 240 Activa BioActive Restorative (Activa) discs', 'aged bioactive restorative material']","['Air abrasion with universal primer (Groups 3 & 7), and Air abrasion with universal adhesive', 'Surface Conditioning', 'Air abrasion']","['Repair SBS using Activa', 'repair shear bond strength (SBS', 'SBS', 'Repair Strength of Bioactive Restorative Material']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",240.0,0.0242661,"Air abrasion produced prominent surface topography changes compared with polishing.
","[{'ForeName': 'Mohamed Moustafa', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Department of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Almutairi', 'Affiliation': 'Department of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Alhalabi', 'Affiliation': 'Department of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Robaian', 'Affiliation': 'Department of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.'}, {'ForeName': 'Fahim Ahmed', 'Initials': 'FA', 'LastName': 'Vohra', 'Affiliation': 'Department of Prosthetic Dental Science, King Saud University, College of Dentistry, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Dental Materials Unit, Center for Dental and Oral Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Maawadh', 'Affiliation': 'Department of Restorative Dental Science, King Saud University, College of Dentistry, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alrahlah', 'Affiliation': 'Department of Restorative Dental Science, King Saud University, College of Dentistry, Riyadh, Saudi Arabia.'}]",Journal of applied biomaterials & functional materials,['10.1177/2280800020926615']
3117,32941098,The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations.,"The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients' biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.",2020,The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.032153,The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma.,"[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'LaVange', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Peters', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'M Alison', 'Initials': 'MA', 'LastName': 'Marquis', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Gotman', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Chalmer', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Georas', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Rosalind J', 'Initials': 'RJ', 'LastName': 'Wright', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Noel', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Rosner', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Akuthota', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Billheimer', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'DiMango', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Serpil C', 'Initials': 'SC', 'LastName': 'Erzurum', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Fahy', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Merritt L', 'Initials': 'ML', 'LastName': 'Fajt', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Gaston', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ngoc P', 'Initials': 'NP', 'LastName': 'Ly', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Moy', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'W Gerald', 'Initials': 'WG', 'LastName': 'Teague', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'White', 'Affiliation': 'Department of Biostatistics, The University of North Carolina at Chapel Hill , Chapel Hill, North Carolina, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2020.1821705']
3118,32941116,"Analgesic efficacy of naproxen-codeine, naproxen+dexamethasone, and naproxen on myofascial pain: A randomized double-blind controlled trial.","OBJECTIVE


To assess the effects of naproxen sodium-codeine phosphate, naproxen sodium-dexamethasone, and naproxen sodium on myofascial pain.
METHODS


This randomized, double-blind prospective clinical study was conducted with patients who applied with the complaint of pain in the temporomandibular region. A total of 169 patients were randomly divided into four groups and received the following treatments: Group A: naproxen sodium 550 mg; Group B: naproxen sodium 550 mg + codeine phosphate 30 mg; Group C: naproxen sodium 550 mg + single-dose dexamethasone 8 mg, and Group D: paracetamol 500 mg.
RESULTS


Of the patients, 132 were female, and 37 were male, with a mean age of 27.04 ± 10.56 (18-69 years). Analgesic efficiency of the naproxen sodium-codeine phosphate group was the most effective at the 2nd week and 4th week ( p  < 0.05).
CONCLUSION


Naproxen sodium-codeine phosphate might be preferred as an analgesic in similar cases with severe myofascial pain.",2020,"Analgesic efficiency of the naproxen sodium-codeine phosphate group was the most effective at the 2nd week and 4th week ( p  < 0.05).
","['similar cases with severe myofascial pain', 'patients who applied with the complaint of pain in the temporomandibular region', 'Of the patients, 132 were female, and 37 were male, with a mean age of 27.04\xa0±\xa010.56', '169 patients']","['naproxen-codeine, naproxen+dexamethasone, and naproxen', 'naproxen sodium 550 mg + codeine phosphate 30 mg; Group C: naproxen sodium 550 mg + single-dose dexamethasone 8 mg, and Group D: paracetamol 500 mg', 'naproxen sodium-codeine phosphate, naproxen sodium-dexamethasone, and naproxen sodium', 'Naproxen sodium-codeine phosphate', 'naproxen sodium', 'naproxen sodium-codeine phosphate']","['Analgesic efficacy', 'Analgesic efficiency', 'myofascial pain']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C2684482', 'cui_str': 'Naproxen sodium 550 MG'}, {'cui': 'C2917839', 'cui_str': 'Codeine Phosphate 30 MG'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0009217', 'cui_str': 'Codeine phosphate'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]",169.0,0.173858,"Analgesic efficiency of the naproxen sodium-codeine phosphate group was the most effective at the 2nd week and 4th week ( p  < 0.05).
","[{'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Cigerim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Van Yuzuncu Yil University , Van, Turkey.'}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Kaplan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tekirdag Namik Kemal University , Tekirdag, Turkey.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1824411']
3119,32941162,Effectiveness of neurobic exercise program on memory and depression among elderly residing at old age home.,"Objectives This study finds out the effectiveness of neurobic exercise program on memory and depression among elderly residing in old age homes. Methods The non-probability purposive sampling technique was used for sample selection. Wechsler's memory scale (WMS-IV) and Geriatric depression scale (GDS) were the instruments used to assess the memory and depression among elderly during the pretest and posttest, respectively and the researcher had developed data sheet to collect information about the background variables using interview technique. Results The neurobic exercise program was found to be effective in reducing depression among elderly residing in old age homes. There was a significant difference (p<0.001) in the level of depression had been found during the pretest and posttest in the interventional group. There was a statistically significant difference (p<0.001) found between the study group and in the control group. There was significant correlation (r=0.417, p<0.05) found between the memory and depression during the pretest in the study group among the elderly. A statistically significant association (p<0.05) found in the mean scores of depression and marital status of the elderly during the pretest in the study group and there was a significant association (p<0.01) found in the mean scores of depression and the gender of the elderly during the pretest and posttest in the non interventional group were found. Conclusions The findings suggested that neurobic exercise program is an effective intervention in improving memory and reducing depression.",2020,There was a statistically significant difference (p<0.001) found between the study group and in the control group.,"['elderly residing in old age homes', 'elderly residing at old age home']",['neurobic exercise program'],"['memory and reducing depression', ""Wechsler's memory scale (WMS-IV) and Geriatric depression scale (GDS"", 'memory and depression', 'level of depression', 'mean scores of depression and marital status']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019870', 'cui_str': 'Old Age Homes'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0175702', 'cui_str': 'Williams syndrome'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024819', 'cui_str': 'Marital status'}]",,0.0139449,There was a statistically significant difference (p<0.001) found between the study group and in the control group.,"[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Raj', 'Affiliation': 'Sri Ramachandra College of Nursing, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Porur, Chennai, 600116, India.'}, {'ForeName': 'Subramaniam', 'Initials': 'S', 'LastName': 'Santhi', 'Affiliation': 'Sri Ramachandra College of Nursing, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Porur, Chennai, 600116, India.'}, {'ForeName': 'G J Sara', 'Initials': 'GJS', 'LastName': 'Sapharina', 'Affiliation': 'Sri Ramachandra College of Nursing, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Porur, Chennai, 600116, India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0221']
3120,32941243,"We Don't Always Have to See the Bones to Know That They're Healing: Commentary on article by P. van Gerven, MD, et al.: ""Omitting Routine Radiography of Traumatic Ankle Fractures After Initial 2-Week Follow-up Does Not Affect Outcomes. The WARRIOR Trial: A Multicenter Randomized Controlled Trial"".",,2020,,['Traumatic Ankle Fractures'],[],[],"[{'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}]",[],[],,0.0971704,,"[{'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Harris', 'Affiliation': 'UCLA Harbor Medical Center, Los Angeles, California.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Pyle', 'Affiliation': 'UCLA Harbor Medical Center, Los Angeles, California.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01051']
3121,32941336,Comparison of Pneumatonometry and Transpalpebral Tonometry Measurements of Intraocular Pressure during Scleral Lens Wear.,"SIGNIFICANCE


As scleral lens wear becomes more common, understanding the impact of these lenses upon ocular physiology is critically important. Studies on the effect of scleral lens wear upon intraocular pressure (IOP) have used different instruments and have reported conflicting results.
PURPOSE


The purpose of this study was to compare assessment of IOP during scleral lens wear using pneumatonometry and transpalpebral tonometry.
METHODS


Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order. IOP was assessed with pneumatonometry and transpalpebral tonometry on both eyes before lens application, immediately after lens application, after 1 hour of lens wear, and immediately after lens removal. Paired t test compared mean IOP in the study eye to the control eye. Repeated-measures ANOVA was performed to take instrumentation, lens diameter, and their interaction into account in an analysis of the change in IOP in the study eye.
RESULTS


Mean peripheral IOP measured with pneumatonometry was not significantly different from baseline at any subsequent measurement. Measurements with transpalpebral tonometry, however, were significantly different during scleral lens wear immediately after application and after 1 hour of wear with both diameter lenses (P < .005), but were not significantly different after either sized lens was removed. Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
CONCLUSIONS


Assessment of IOP during scleral lens wear varies based upon the instrument that is used. Although further studies are clearly needed to further elucidate this issue, clinicians should continue to monitor optic nerve structure and function in scleral lens wearers, as they do in all patients.",2020,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
","['Intraocular Pressure during Scleral Lens Wear', 'Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order']","['scleral lens wear upon intraocular pressure (IOP', 'Pneumatonometry and Transpalpebral Tonometry Measurements', 'pneumatonometry and transpalpebral tonometry']","['Mean peripheral IOP', 'IOP', 'IOP changes']","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.042258,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
","[{'ForeName': 'Jennifer Swingle', 'Initials': 'JS', 'LastName': 'Fogt', 'Affiliation': 'The Ohio State University, College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Cherie B', 'Initials': 'CB', 'LastName': 'Nau', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Schornack', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Shorter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Nau', 'Affiliation': 'Korb & Associates, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Harthan', 'Affiliation': 'Illinois College of Optometry, Chicago, Illinois.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001574']
3122,32941439,"""What you say and how you say it"" matters: An experimental evidence of the role of synchronicity, modality, and message valence during smartphone-mediated communication.","Nowadays, smartphone-Mediated Communication (SMC) has become a popular form of social interactions. The present experimental study manipulated three aspects of messaging in a WhatsApp chat as a form of SMC: synchronicity (immediate vs. time-lagged response), modality (with or without emojis), and valence (empathic accurate vs. empathic inaccurate response). The aim of this study was to investigate whether these three aspects had an impact on perceived social support, interpersonal trust, and personality attribution of the communication partner. The partial mediation of perceived social presence (the evaluation of the communication partner's accessibility) and subjective social presence (the perception of being concordant with him/her) was also examined. Participants were 160 young adults, balanced in gender. They were randomly assigned to different the experimental conditions where they engaged in a manipulated WhatsApp chat with a fictitious same-gender communication partner. Post-questionnaire data were analyzed using Structural Equation Modeling. Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence. Synchronicity (immediate response) predicted higher levels of perceived but not subjective social presence. Social presence, in turn, was positively associated with social support, while subjective, but not perceived social presence, was positively associated with personality attribution. Neither perceived nor subjective social presence were related to interpersonal trust. Our results show that both what is said and how it is said impact the experience of interpersonal relations in SMC.",2020,Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence.,"['Participants were 160 young adults, balanced in gender']",['smartphone-Mediated Communication (SMC'],"['Message valence (empathic accurate response', 'subjective social presence', 'perceived social support, interpersonal trust, and personality attribution of the communication partner']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",160.0,0.0152429,Message valence (empathic accurate response) and modality (with emojis) significantly predicted higher levels of both forms of social presence.,"[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Petrocchi', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Marciano', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Annoni', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}, {'ForeName': 'Anne-Linda', 'Initials': 'AL', 'LastName': 'Camerini', 'Affiliation': 'Faculty of Communication, Culture and Society, Università della Svizzera italiana, Lugano, Switzerland.'}]",PloS one,['10.1371/journal.pone.0237846']
3123,32941462,Provider anticipation and experience of patient reaction when deprescribing guideline discordant inhaled corticosteroids.,"INTRODUCTION


Despite evidence of possible patient harm and substantial costs, medication overuse is persistent. Patient reaction is one potential barrier to deprescribing, but little research has assessed this in specific instances of medication discontinuation. We sought to understand Veteran and provider experience when de-implementing guideline-discordant use of inhaled corticosteroids (ICS) in those with mild-to-moderate chronic obstructive pulmonary disease (COPD).
METHODS


We conducted a mixed-methods analysis in a provider-randomized quality improvement project testing a proactive electronic-consultation from pulmonologists recommending ICS discontinuation when appropriate. PCPs at two Veterans Health Administration healthcare systems were included. We completed interviews with 16 unexposed providers and 6 intervention-exposed providers. We interviewed 9 patients within 3 months after their PCP proposed ICS discontinuation. We conducted inductive and deductive content analysis of qualitative data to explore an emergent theme of patient reaction. Forty-eight PCPs returned surveys (24 exposed and 24 unexposed, response rate: 35%).
RESULTS


The unexposed providers anticipated their patients might resist ICS discontinuation because it seems counterintuitive to stop something that is working, patient's fear of worsening symptoms, or if the prescription was initiated by another provider. Intervention-exposed providers reported similar experiences in post-intervention interviews. Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies. This was echoed by intervention-exposed providers who had successfully discontinued an ICS. Veterans reported acceding to their providers out of trust or deference to their advanced training, even after describing an ICS as a 'security blanket'. Our survey findings supported the subthemes from our interviews. Among providers who proposed discontinuation of an ICS, 76% reported that they were able to discontinue it or switch to another more appropriate medication.
CONCLUSIONS


While PCPs anticipated that patients would resist discontinuing an ICS, interviews with patient and intervention-exposed PCPs along with surveys suggest that patients were receptive to this change.",2020,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","['16 unexposed providers and 6 intervention-exposed providers', 'those with mild-to-moderate chronic obstructive pulmonary disease (COPD']",['inhaled corticosteroids (ICS'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],9.0,0.0455836,"Unexposed providers anticipated that patients may accept ICS discontinuation, citing tactical use of patient-centered care strategies.","[{'ForeName': 'Toral J', 'Initials': 'TJ', 'LastName': 'Parikh', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Krysttel C', 'Initials': 'KC', 'LastName': 'Stryczek', 'Affiliation': 'VA Northeast Ohio Healthcare System, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Sayre', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Feemster', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Majerczyk', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Seppo T', 'Initials': 'ST', 'LastName': 'Rinne', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'Renda Soylemez', 'Initials': 'RS', 'LastName': 'Wiener', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts, United States of America.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Seattle-Denver Center of Innovation for Veteran-Centered & Value-Driven Care, VA Puget Sound Healthcare System, Seattle, Washington, United States of America.'}]",PloS one,['10.1371/journal.pone.0238511']
3124,32941476,A randomized pilot trial to evaluate the benefit of the concomitant use of atorvastatin and Raltegravir on immunological markers in protease-inhibitor-treated subjects living with HIV.,"OBJECTIVE


Optimization of antiretroviral therapy and anti-inflammatory treatments, such as statins, are among the strategies aimed at reducing metabolic disorders, inflammation and immune activation in people living with HIV (PLWH). We evaluated the potential benefit of combining both strategies.
DESIGN


Forty-two PLWH aged ≥40 years receiving a protease inhibitor (PI)-based regimen were randomized (1:1) to switch from PI to Raltegravir (n = 20), or to remain on PI (n = 22). After 24 weeks, all patients received atorvastatin 20mg/day for 48 weeks.
METHODS


We analyzed plasma inflammatory as well as T-cell maturation, activation, exhaustion and senescence markers at baseline, 24 and 72 weeks.
RESULTS


Plasma inflammatory markers remained unchanged. Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed. Only a modest decrease in the frequency of CD38+ CD8 T cells and an increase in the frequency of CD28-CD57+ in both CD4 and CD8 T-cell compartments were noticed in the Raltegravir-switched group.
CONCLUSIONS


The study combined antiretroviral switch to Raltegravir and Statin-based anti-inflammatory strategies to reduce inflammation and chronic immune activation in PLWH. Although this combination was safe and well tolerated, it had minimal impact on inflammatory and immunological markers.
CLINICAL TRIALS REGISTRATION


NCT02577042.",2020,"Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed.","['Forty-two PLWH aged ≥40 years receiving a protease inhibitor (PI)-based regimen', 'protease-inhibitor-treated subjects living with HIV', 'people living with HIV (PLWH']","['atorvastatin and Raltegravir', 'Raltegravir and Statin-based anti-inflammatory strategies', 'atorvastatin', 'Raltegravir']","['T-cell maturation, activation, exhaustion and senescence markers', 'safe and well tolerated', 'frequency of CD28-CD57+ in both CD4 and CD8 T-cell compartments', 'frequency of CD38+ CD8 T cells', 'T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0075747', 'cui_str': 'Lymphocyte antigen CD28'}, {'cui': 'C0054965', 'cui_str': 'Lymphocyte antigen CD57'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0596761', 'cui_str': 'Immunosenescence'}]",,0.0296761,"Furthermore, no major changes on T-cell maturation subsets, immunoactivation, exhaustion or immunosenescence markers in both CD4 and CD8 T cell compartments were observed.","[{'ForeName': 'Eugènia', 'Initials': 'E', 'LastName': 'Negredo', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Jiménez', 'Affiliation': 'AIDS Research Institute-IrsiCaixa, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Puig', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Loste', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Pérez-Álvarez', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Urrea', 'Affiliation': 'AIDS Research Institute-IrsiCaixa, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Echeverría', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bonjoch', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Bonaventura', 'Initials': 'B', 'LastName': 'Clotet', 'Affiliation': 'Lluita Contra la SIDA Foundation, Germans Trias i Pujol Research Institute-IGTP, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Catalonia, Spain.'}, {'ForeName': 'Julià', 'Initials': 'J', 'LastName': 'Blanco', 'Affiliation': 'Infectious Diseases and Immunity, Centre for Health and Social Care Research (CESS), Faculty of Medicine, University of Vic-Central University of Catalonia (UVic-UCC), Catalonia, Spain.'}]",PloS one,['10.1371/journal.pone.0238575']
3125,32941526,Muscle activation with swinging loads in bench press.,"The aim of the study was to compare the EMG amplitude in bench press (stable loads) to bench press using loads moving in anteroposterior and mediolateral directions. Seventeen resistance-trained men, with 9.4±4.7 years of resistance training experience were recruited. After a familiarization session assessing 1 repetition maximum (RM) in the bench press, participants performed: 1) bench press with traditional stable loading 2) bench press with loads (2x5kg) attached as pendulums swinging forward/backwards and 3) left/right in randomized order. The total load was 70% of the 1RM load. Electromyography was measured in the pectoralis major, anterior- and posterior deltoid, biceps brachii, triceps brachii and external obliques. Using stable loads, the pectoralis major demonstrated lower EMG amplitude compared to the two unstable conditions. In the external obliques, the stable conditions demonstrated lower EMG amplitude than the swing in the mediolateral direction, but not the anteroposterior direction. There were no differences between two swinging loads or the three conditions for the triceps brachii, biceps brachii, anterior deltoid or posterior deltoid. In conclusion, swinging in bench press resulted in similar EMG amplitude in the shoulder- and arm muscles, but greater pectoralis and external oblique (only mediolateral swing) activity compared to bench press.",2020,"There were no differences between two swinging loads or the three conditions for the triceps brachii, biceps brachii, anterior deltoid or posterior deltoid.","['Seventeen resistance-trained men, with 9.4±4.7 years of resistance training experience were recruited']",['traditional stable loading 2) bench press with loads (2x5kg) attached as pendulums swinging forward/backwards and 3) left/right'],"['triceps brachii, biceps brachii, anterior deltoid or posterior deltoid', 'EMG amplitude', 'similar EMG amplitude', 'pectoralis and external oblique (only mediolateral swing) activity', 'total load']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0224375', 'cui_str': 'External Oblique Muscle'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0222778,"There were no differences between two swinging loads or the three conditions for the triceps brachii, biceps brachii, anterior deltoid or posterior deltoid.","[{'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Tom Erik Jorung', 'Initials': 'TEJ', 'LastName': 'Solstad', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Matthew Peter', 'Initials': 'MP', 'LastName': 'Shaw', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}]",PloS one,['10.1371/journal.pone.0239202']
3126,32941528,Correction: Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial.,[This corrects the article DOI: 10.1371/journal.pone.0232685.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0232685.].,['children with cystic fibrosis treated with a'],['novel oral structured lipid supplement'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]",[],,0.032671,[This corrects the article DOI: 10.1371/journal.pone.0232685.].,"[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ''}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Tindall', 'Affiliation': ''}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Mascarenhas', 'Affiliation': ''}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Maqbool', 'Affiliation': ''}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0239642']
3127,32942043,Rationale and design of the Medical Research Council's Precision Medicine with Zibotentan in Microvascular Angina (PRIZE) trial.,"Microvascular angina is caused by cardiac small vessel disease, and dysregulation of the endothelin system is implicated. The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1. The prevalence of this allele is higher in patients with ischemic heart disease. Zibotentan is a potent, selective inhibitor of the ET A  receptor. We have identified zibotentan as a potential disease-modifying therapy for patients with microvascular angina. METHODS: We will assess the efficacy and safety of adjunctive treatment with oral zibotentan (10 mg daily) in patients with microvascular angina and assess whether rs9349379 (minor G allele; population prevalence ~36%) acts as a theragnostic biomarker of the response to treatment with zibotentan. The PRIZE trial is a prospective, randomized, double-blind, placebo-controlled, sequential cross-over trial. The study population will be enriched to ensure a G-allele frequency of 50% for the rs9349379 SNP. The participants will receive a single-blind placebo run-in followed by treatment with either 10 mg of zibotentan daily for 12 weeks then placebo for 12 weeks, or vice versa, in random order. The primary outcome is treadmill exercise duration using the Bruce protocol. The primary analysis will assess the within-subject difference in exercise duration following treatment with zibotentan versus placebo. CONCLUSION: PRIZE invokes precision medicine in microvascular angina. Should our hypotheses be confirmed, this developmental trial will inform the rationale and design for undertaking a larger multicenter trial.",2020,"The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1.","['patients with microvascular angina', 'microvascular angina', 'patients with ischemic heart disease', 'patients with microvascular angina and assess whether rs9349379 (minor G allele; population prevalence ~36']","['placebo', 'oral zibotentan', 'zibotentan versus placebo']","['exercise duration', 'efficacy and safety', 'treadmill exercise duration using the Bruce protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0442713', 'cui_str': 'Bruce protocol'}]",,0.469459,"The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Morrow', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Kotecha', 'Affiliation': 'Royal Free Hospital, Royal Free London NHS Foundation Trust London, United Kingdom.'}, {'ForeName': 'Roby', 'Initials': 'R', 'LastName': 'Rakhit', 'Affiliation': 'Royal Free Hospital, Royal Free London NHS Foundation Trust London, United Kingdom.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Galasko', 'Affiliation': 'Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hoole', 'Affiliation': 'Department of Interventional Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'Experimental Medicine and Immunotherapeutics, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kharbanda', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom; Department of Cardiology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Ferreira', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Mayooran', 'Initials': 'M', 'LastName': 'Shanmuganathan', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Chiribiri', 'Affiliation': ""Division of Imaging Sciences, Guy's and St Thomas' Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Divaka', 'Initials': 'D', 'LastName': 'Perera', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Haseeb', 'Initials': 'H', 'LastName': 'Rahman', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Jayanth R', 'Initials': 'JR', 'LastName': 'Arnold', 'Affiliation': 'Department of Cardiovascular Sciences, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Liverpool University and Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Husmeier', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Hill', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Genetics, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Department of Clinical Genetics, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Dempster', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Macfarlane', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whittaker', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences, R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alex Mc', 'Initials': 'AM', 'LastName': 'Connachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Sandosh', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom. Electronic address: colin.berry@glasgow.ac.uk.'}]",American heart journal,['10.1016/j.ahj.2020.07.007']
3128,32942053,Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults.,"The symptom burden of HIV-associated neurocognitive disorder (HAND) is high among older individuals, and treatment options are limited. Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking. In this trial, participants (N = 180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND, are randomized to MBSR or to a waitlist control arm that receives MBSR following a 16-week period of standard care. Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness) are assessed at baseline and weeks 8, 16, and 48 in both groups, with an additional assessment at week 24 (post-MBSR) in the crossover control group. Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs). In addition, a subset of participants (n = 30 per group) are randomly selected to undergo fMRI to evaluate changes in functional connectivity networks and their relationship to changes in neuropsychological outcomes. Forthcoming findings from this randomized controlled trial have the potential to contribute to a growing public health need as the number of older adults with HAND is expected to rise.",2020,"Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking.","['older adults', 'HIV-associated neurocognitive disorder', 'participants (N\u202f=\u202f180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND']","['Mindfulness-based stress reduction (MBSR', 'Mindfulness-based stress reduction']","['neurocognitive performance, psychosocial wellbeing, and quality of life', 'symptom burden of HIV-associated neurocognitive disorder (HAND', 'Primary outcomes (attention, executive function, stress, anxiety, depression, everyday functioning, quality of life) and potential mediators (affect, mindfulness) and moderators (social support, loneliness', 'Assessments include self-report and objective measures (e.g., neuropsychological assessment, neurological exam, clinical labs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",180.0,0.0447385,"Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Addington', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Osher Center for Integrative Medicine, Northwestern University, Chicago, IL, USA. Electronic address: elizabeth.addington@northwestern.edu.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Javandel', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'De Gruttola', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Missouri Institute of Mental Health, University of Missouri-St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Milanini', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}, {'ForeName': 'Beau M', 'Initials': 'BM', 'LastName': 'Ances', 'Affiliation': 'Department of Neurology, Washington University in St. Louis, School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Osher Center for Integrative Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Valcour', 'Affiliation': 'Memory and Aging Center, Department of Neurology, University of California, San Francisco, California, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106150']
3129,32942054,Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention.,"BACKGROUND


Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun.
METHODS


A randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
RESULTS


The state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection.
CONCLUSIONS


Digital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03278340.",2020,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","['Departments of transportation (DOTs) from 21\u202fU.S. states are participating and their 138 regional districts', 'adults who work outdoors in the sun']","['scaling-up the Sun Safe Workplaces (SSW) intervention', 'scaling-up an occupational sun protection intervention']",[],"[{'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",[],,0.139656,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Research at Klein Buendel, Inc, A Health Communication and Media Development Firm, Golden, CO, USA. Electronic address: dbuller@kleinbuendel.com.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'President at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Investigator at Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Emeritus at the University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Research Program Manager at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eye', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106147']
3130,32942085,A Phase 2 Study of AMO-02 (Tideglusib) in Congenital and Childhood-Onset Myotonic Dystrophy Type 1 (DM1).,"BACKGROUND


GSK3β is an intracellular regulatory kinase that is dysregulated in multiple tissues in type 1 myotonic dystrophy, a rare neuromuscular disorder that manifests at any age. AMO-02 (tideglusib) inhibits GSK3β activity in preclinical models of type 1 myotonic dystrophy and promotes cellular maturation as well as normalizes aberrant molecular and behavioral phenotypes. This phase 2 study assessed the pharmacokinetics, safety and tolerability, and preliminary efficacy of AMO-02 in adolescents and adults with congenital and childhood-onset type 1 myotonic dystrophy.
METHODS


Sixteen subjects (aged 13 to 34 years) with congenital and childhood-onset type 1 myotonic dystrophy received 12 weeks of single-blind fixed-dose oral treatment with either 400 mg (n = 8) or 1000 mg (n = 8) AMO-02 (NCT02858908). Blood samples were obtained for pharmacokinetic assessment. Safety assessments, such as laboratory tests and electrocardiograms, as well as efficacy assessments of syndromal, cognitive, and muscular functioning, were obtained.
RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed. AMO-02 was generally safe and well-tolerated. No early discontinuations due to adverse events or dose adjustments of AMO-02 occurred. The majority of subjects manifested clinical improvement in their central nervous system and neuromuscular symptoms after 12 weeks of treatment compared with the placebo baseline, with a larger response noted at the 1000 mg/day dose level. AMO-02 exposure (cumulative area under the curve) was significantly correlated (P < 0.01) with change from baseline on several key efficacy assessments.
CONCLUSION


AMO-02 has favorable pharmacokinetic and clinical risk/benefit profiles meriting further study as a potential treatment for congenital and childhood-onset type 1 myotonic dystrophy.",2020,"RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed.","['Sixteen subjects (aged 13 to 34 years) with congenital and childhood-onset type 1 myotonic dystrophy received 12\xa0weeks of', 'adolescents and adults with congenital and childhood-onset type 1 myotonic dystrophy']","['AMO-02', 'AMO-02 (Tideglusib', 'single-blind fixed-dose oral treatment with either 400\xa0mg (n\xa0=\xa08) or 1000\xa0mg (n\xa0=\xa08) AMO-02']","['Safety assessments, such as laboratory tests and electrocardiograms, as well as efficacy assessments of syndromal, cognitive, and muscular functioning', 'AMO-02 exposure (cumulative area under the curve', 'central nervous system and neuromuscular symptoms', 'safe and well-tolerated', 'AMO-02 plasma concentrations', 'pharmacokinetics, safety and tolerability']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.194485,"RESULTS


AMO-02 plasma concentrations conformed to a two-compartment model with first-order absorption and elimination, and dose-dependent increases in exposure (area under the curve) were observed.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Horrigan', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK. Electronic address: joe.horrigan@amo-pharma.com.'}, {'ForeName': 'Tiago Bernardino', 'Initials': 'TB', 'LastName': 'Gomes', 'Affiliation': 'John Walton Muscular Dystrophy Research Centre, Institute of Genetic Medicine, Newcastle University, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Nikoletta', 'Initials': 'N', 'LastName': 'Nikolenko', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, Queen Square, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McMorn', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'AMO Pharma Ltd, Wonersh, Surrey, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yaroshinsky', 'Affiliation': 'Vital Systems, Inc., Wichita Falls, Texas.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Della Pasqua', 'Affiliation': 'Clinical Pharmacology and Therapeutics, University College London, London, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Oosterholt', 'Affiliation': 'Clinical Pharmacology and Therapeutics, University College London, London, UK.'}, {'ForeName': 'Hanns', 'Initials': 'H', 'LastName': 'Lochmüller', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute; Division of Neurology, Department of Medicine, The Ottawa Hospital; and Brain and Mind Research Institute, University of Ottawa, Ottawa, Canada.""}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.08.001']
3131,32947060,Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome.Randomized Controlled Clinical Trial.,"INTRODUCTION


Inguinal hernioplasty is the standard treatment for inguinal hernia in adults. Mesh fixation was used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair in adults, but their effectiveness has remained inconclusive.
AIM OF THE WORK


to evaluate non fixation method of mesh laparoscopic inguinal hernioplasty as safe and effective as regard short and long term outcomes.
PATIENTS AND METHODS


Over the period from July 2013 to July 2018, 798 patients with oblique inguinal hernias undergoing Trans abdominal preperitoneal technique (TAPP) were randomized into 3 groups: Group A; mesh non fixation 266 patients. Group B; tacker mesh fixation 266 patients Group C: Cyanoacrylic tissue glues (Histoacryl) mesh fixation 266 patients. Clinical effects were assessed by the following variables: intraoperative data, postoperative outcome as regard recurrence rate, postoperative pain [on visual analogue score (VAS)], analgesic consumption, operation time, hospital stay, and patient costs. Follow up was 18 months.
RESULTS


There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score. In Group (B): the postoperative pain and complications were higher. There were 5 cases of hernia recurrence in all groups, but no significant differences among the three groups.
CONCLUSION


Tacker Mesh fixation increased the risk of chronic groin pain. Pain score was higher with tacker mesh fixation. Laparoscopic TAPP inguinal hernia repair without tacker mesh fixation was safe and feasible with no significant increase in recurrence rates. Furthermore, mesh fixation with tacker procedure increased the risk of postoperative complications and patient costs.
RESEARCH QUESTION


is non-mechanical fixation of the mesh more safe and more effective than mechanical tacker fixation as regard short term and long term outcome?
HYPOTHESIS


non mechanical mesh fixation is more safe and more effective than mechanical fixation of the mesh as regard short term and long term outcome. REGISTRATION AT CLINICALTRIALS.
GOV PROTOCOL REGISTRATION QUALITY CONTROL REVIEW CRITERIA


NCT04272424. All ethical approval was given by our Faculty of Medicine medical ethical committee. (HNWD, 207).",2020,"There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score.","['Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults', '266 patients Group C', 'Over the period from July 2013 to July 2018, 798 patients with oblique inguinal hernias undergoing', 'inguinal hernia in adults', '266 patients']","['Cyanoacrylic tissue glues (Histoacryl) mesh fixation', 'Mesh Fixation', 'Inguinal hernioplasty', 'Laparoscopic TAPP inguinal hernia repair without tacker mesh fixation', 'mesh non fixation', 'Mesh fixation', 'tacker mesh fixation', 'Tacker Mesh fixation', 'Trans abdominal preperitoneal technique (TAPP', 'laparoscopic inguinal hernioplasty', 'mechanical tacker fixation']","['risk of chronic groin pain', 'operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score', 'postoperative pain and complications', 'intraoperative data, postoperative outcome as regard recurrence rate, postoperative pain [on visual analogue score (VAS)], analgesic consumption, operation time, hospital stay, and patient costs', 'recurrence rates', 'hernia recurrence', 'Pain score', 'risk of postoperative complications and patient costs']","[{'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0019296', 'cui_str': 'Indirect inguinal hernia'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",798.0,0.0914316,"There was no statistical difference between groups (A) and Group (C) regarding operative time, postoperative complications, and length of hospital stay and risk of chronic groin pain, postoperative pain score.","[{'ForeName': 'Tamer A A M', 'Initials': 'TAAM', 'LastName': 'Habeeb', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt. Electronic address: tameralnaimy@hotmail.com.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Mahmoud Mokhtar', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Sieda', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Osman', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Abd-Elrahman M', 'Initials': 'AM', 'LastName': 'Metwalli', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Riad', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Osama M H', 'Initials': 'OMH', 'LastName': 'Khalil', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed Ibrahim', 'Initials': 'MI', 'LastName': 'Mansour', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Tamer Mohamed', 'Initials': 'TM', 'LastName': 'Elshahidy', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Moustafa B', 'Initials': 'MB', 'LastName': 'Mohamed', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Zagazig University, Egypt.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.013']
3132,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND


International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES


The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS


The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS


Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS


This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
3133,32941530,"Results of the 3 Pillars Study (3PS), a relationship-based programme targeting parent-child interactions, healthy lifestyle behaviours, and the home environment in parents of preschool-aged children: A pilot randomised controlled trial.","BACKGROUND


Early childhood is a critical period for the development of obesity, with new approaches to prevent obesity in this age group needed. We designed and piloted the 3 Pillars Study (3PS), a healthy lifestyle programme informed by attachment theory for parents of preschool-aged children.
METHODS


A 2-arm, randomised controlled pilot study was conducted to assess the effectiveness of 3PS, a 6-week programme involving a half-day workshop plus 6-week access to a study website. The programme was designed to promote routines around healthy lifestyle behaviours, including sleep, limited screen use, and family meals, within the context of positive, reciprocal parent-child interactions. Parents (n = 54) of children aged 2-4 years who regularly exceeded screen use recommendations (≥1 hour per day), were randomised to the 3PS programme (n = 27) or a wait-list control group (n = 27). Child screen time at 6 weeks was the primary endpoint. Frequency of family meals, parent feeding practices, diet quality, sleep, Child Routine Inventory (to assess predictability of commonly occurring routines), and household chaos were also assessed. Study data were collected online at baseline, 6 weeks, and 12 weeks via REDCap.
RESULTS


No group differences were observed for changes from baseline in screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration at 6 and 12 weeks, although all measures improved in the hypothesised direction in the 3PS group. Compared with controls, the intervention group demonstrated significant improvements from baseline in household chaos scores (i.e. a reduction in chaos) and a number of measures of sleep outcomes, indicating improved sleep continuity. The programme was highly acceptable to parents.
CONCLUSIONS AND RECOMMENDATIONS


A relational approach appears promising as a novel way to promote healthy lifestyle behaviours associated with the prevention of childhood obesity in children aged 2-4 years. A larger study is warranted.",2020,"No group differences were observed for changes from baseline in screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration at 6 and 12 weeks, although all measures improved in the hypothesised direction in the 3PS group.","['for parents of preschool-aged children', 'parents of preschool-aged children', 'children aged 2-4 years', 'Parents (n = 54) of children aged 2-4 years who regularly exceeded screen use recommendations ']","['3PS', '3PS programme', 'healthy lifestyle programme informed by attachment theory']","['screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration', 'Child screen time', 'sleep continuity', 'household chaos scores', 'number of measures of sleep outcomes', 'Frequency of family meals, parent feeding practices, diet quality, sleep, Child Routine Inventory (to assess predictability of commonly occurring routines), and household chaos']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1194380', 'cui_str': 'Chaos'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",,0.100448,"No group differences were observed for changes from baseline in screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration at 6 and 12 weeks, although all measures improved in the hypothesised direction in the 3PS group.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Marsh', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gerritsen', 'Affiliation': 'Epidemiology and Biostatistics, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parag', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}]",PloS one,['10.1371/journal.pone.0238977']
3134,32941649,Evaluating upfront high-dose consolidation after R-CHOP for follicular lymphoma by clinical and genetic risk models.,"High-dose therapy and autologous stem cell transplantation (HDT/ASCT) is an effective salvage treatment for eligible patients with follicular lymphoma (FL) and early progression of disease (POD). Since the introduction of rituximab, HDT/ASCT is no longer recommended in first remission. We here explored whether consolidative HDT/ASCT improved survival in defined subgroups of previously untreated patients. We report survival analyses of 431 patients who received frontline rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for advanced FL, and were randomized to receive consolidative HDT/ASCT. We performed targeted genotyping of 157 diagnostic biopsies, and calculated genotype-based risk scores. HDT/ASCT improved failure-free survival (FFS; hazard ratio [HR], 0.8, P = .07; as-treated: HR, 0.7, P = .04), but not overall survival (OS; HR, 1.3, P = .27; as-treated: HR, 1.4, P = .13). High-risk cohorts identified by FL International Prognostic Index (FLIPI), and the clinicogenetic risk models m7-FLIPI and POD within 24 months-prognostic index (POD24-PI) comprised 27%, 18%, and 22% of patients. HDT/ASCT did not significantly prolong FFS in high-risk patients as defined by FLIPI (HR, 0.9; P = .56), m7-FLIPI (HR, 0.9; P = .91), and POD24-PI (HR, 0.8; P = .60). Similarly, OS was not significantly improved. Finally, we used a machine-learning approach to predict benefit from HDT/ASCT by genotypes. Patients predicted to benefit from HDT/ASCT had longer FFS with HDT/ASCT (HR, 0.4; P = .03), but OS did not reach statistical significance. Thus, consolidative HDT/ASCT after frontline R-CHOP did not improve OS in unselected FL patients and subgroups selected by genotype-based risk models.",2020,"HDT/ASCT improved failure-free survival (FFS; hazard ratio [HR], 0.8, P = .07; as-treated: HR, 0.7, P = .04), but not overall survival (OS; HR, 1.3, P = .27; as-treated: HR, 1.4, P = .13).","['431 patients who received', 'eligible patients with follicular lymphoma (FL) and early progression of disease (POD']","['High-dose therapy and autologous stem cell transplantation (HDT/ASCT', 'HDT/ASCT', 'frontline rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'consolidative HDT/ASCT', 'rituximab, HDT/ASCT']","['failure-free survival', 'OS', 'FFS', 'overall survival', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0627849,"HDT/ASCT improved failure-free survival (FFS; hazard ratio [HR], 0.8, P = .07; as-treated: HR, 0.7, P = .04), but not overall survival (OS; HR, 1.3, P = .27; as-treated: HR, 1.4, P = .13).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Alig', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Vindi', 'Initials': 'V', 'LastName': 'Jurinovic', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shahrokh Esfahani', 'Affiliation': 'Division of Oncology, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Haebe', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Passerini', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Hellmuth', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Gaitzsch', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Keay', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Natyra', 'Initials': 'N', 'LastName': 'Tahiri', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zoellner', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, University of Würzburg, and Comprehensive Cancer Center Mainfranken, Würzburg, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Hematopathology Section, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Stein', 'Affiliation': 'Pathodiagnostik Berlin, Berlin, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Feller', 'Affiliation': 'Hematopathology Lübeck, Lübeck, Germany.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Ott', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Staiger', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Horn', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Hansmann', 'Affiliation': 'Senckenberg Institute of Pathology, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'Second Medical Department, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Unterhalt', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Ash A', 'Initials': 'AA', 'LastName': 'Alizadeh', 'Affiliation': 'Division of Oncology, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Weigert', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}]",Blood advances,['10.1182/bloodadvances.2020002546']
3135,32941700,Influence of altitude on hypertension phenotypes and responses to antihypertensive therapy: Review of the literature and design of the INTERVENCION trial.,"Systemic arterial hypertension constitutes the leading cause of mortality worldwide, and affects people living at different altitudes above sea level (AASL). AASL has a major impact on cardiovascular function and various biologic pathways that regulate blood pressure-related phenotypes, but whether it affects the clinical response to antihypertensive therapy is unknown. The hemodynamic adaptations observed among lowlanders acutely exposed to high altitude (HA) is distinct from those observed among HA dwellers. However, the phenotypic patterns of hypertension and the response to standard antihypertensive agents among adults chronically exposed to different AASL are poorly understood. The authors describe the protocol for the INTERVENCION trial, a randomized clinical trial designed to assess the effects of three first-line antihypertensive monotherapies (a thiazide diuretic, an angiotensin receptor blocker, and a calcium channel blocker) on peripheral and central blood pressure, in-office blood pressure, and ambulatory blood pressure hemodynamics of hypertensive patients living at different AASL (low altitude, intermediate altitude, and high altitude). The primary end point is the reduction in 24-hour brachial systolic blood pressure. The INTERVENCION trial will provide the first clinical trial data regarding the influence of AASL on the response to antihypertensive monotherapy, as well as the hemodynamic characteristics of arterial hypertension at different AASL.",2020,The hemodynamic adaptations observed among lowlanders acutely exposed to high altitude (HA) is distinct from those observed among HA dwellers.,"['hypertensive patients living at different AASL (low altitude, intermediate altitude, and high altitude']","['thiazide diuretic, an angiotensin receptor blocker, and a calcium channel blocker']","['peripheral and central blood pressure, in-office blood pressure, and ambulatory blood pressure hemodynamics', '24-hour brachial systolic blood pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0238618', 'cui_str': 'Low altitude'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}]","[{'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0313072,The hemodynamic adaptations observed among lowlanders acutely exposed to high altitude (HA) is distinct from those observed among HA dwellers.,"[{'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Medina-Lezama', 'Affiliation': 'PREVENCION Research Institute, Santa Maria Catholic University School of Medicine, Arequipa, Peru.'}, {'ForeName': 'Karela', 'Initials': 'K', 'LastName': 'Herrera-Enriquez', 'Affiliation': 'PREVENCION Research Institute, Santa Maria Catholic University School of Medicine, Arequipa, Peru.'}, {'ForeName': 'Offdan', 'Initials': 'O', 'LastName': 'Narvaez-Guerra', 'Affiliation': 'PREVENCION Research Institute, Santa Maria Catholic University School of Medicine, Arequipa, Peru.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13932']
3136,32941704,Development and validation of prognostic nomogram in patients with nonmetastatic malignant melanoma: a SEER population-based study.,"BACKGROUND


The condition of tumor recurrence and overall death can be worried in the progress of nonmetastatic malignant melanoma (NMMM). Our goal was to construct and validate a prognostic nomogram from a large population database, which is vital for physicians to predict the 3- and 5-year overall survival (OS) rates of patients with NMMM.
METHODS


According to the Surveillance, Epidemiology, and End Results (SEER) program, patients were collected and randomly assigned into the training and validation cohorts. Several independent risk factors were identified based on the methods of univariable and multivariable cox hazards regression and were incorporated to develop a nomogram. The concordance index (C-index), the area under the receiver operating characteristics (AUC) curve and calibration plot were confirmed to assess predictive power of the nomogram. Decision curve analysis (DCA) was performed to measure nomogram for the clinical practice.
RESULTS


A total of 66192 eligible patients, randomly assigned into 70% of training (n = 46 336) and 30% of validation cohorts (n = 19 856), were selected in this study. The selected independent factors were applied to develop a nomogram, and validated indexes indicated nomogram had a good discrimination ability. The C-index for OS rates was 0.817 (95% CI: 0.811-0.823) in training cohort and 0.817 (95% CI: 0.809-0.825) in validation cohort, respectively. The AUCs of 3- and 5-year OS rates were more than 0.79, and the calibration plots also showed a good power for the nomogram. DCA demonstrated that constructed nomogram can provide clinical net benefit.
CONCLUSION


We constructed a novel nomogram that more accurately and comprehensively predict OS with nonmetastatic malignant melanoma patients, which is vital for clinician to improve individual treatment, make reasonable clinical decisions, and set appropriate follow-up strategies.",2020,"The C-index for OS rates was 0.817 (95% CI: 0.811-0.823) in training cohort and 0.817 (95% CI: 0.809-0.825) in validation cohort, respectively.","['66192 eligible patients, randomly assigned into 70% of training (n\xa0', '46\xa0336) and 30% of validation cohorts (n\xa0=\xa019\xa0856', 'patients with nonmetastatic malignant melanoma', 'nonmetastatic malignant melanoma patients', 'patients with NMMM']",['DCA'],"['concordance index (C-index), the area under the receiver operating characteristics (AUC) curve and calibration plot', 'AUCs of 3- and 5-year OS rates', '5-year overall survival (OS) rates', 'C-index for OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517894', 'cui_str': '856'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",66192.0,0.149323,"The C-index for OS rates was 0.817 (95% CI: 0.811-0.823) in training cohort and 0.817 (95% CI: 0.809-0.825) in validation cohort, respectively.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'The Central Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'The Central Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Youhong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, China.'}, {'ForeName': 'Xianwei', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'The First Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, China.'}]",Cancer medicine,['10.1002/cam4.3318']
3137,32941737,PRIOR INGESTION OF A KETONE MONOESTER SUPPLEMENT REDUCES POSTPRANDIAL GLYCEMIC RESPONSES IN YOUNG HEALTHY WEIGHT INDIVIDUALS.,"The main objective of this study was to determine whether acute ingestion of a ketone monoester (KME) supplement impacted mixed meal tolerance test (MMTT) glucose area under the curve (AUC). Nineteen healthy young volunteers (10 males/9 females, 24.7 ± 4.9 years, BMI = 22.7 ± 2.4) participated in a double-blind, placebo-controlled crossover study. Following overnight fasting (≥10 h), participants consumed 0.45mL/kg of a KME supplement or taste-matched placebo followed by a MMTT 15 minutes later. Blood samples were collected every 15-30 minutes over 2.5 hours. KME supplementation acutely raised beta-hydroxybutyrate (β-OHB) AUC (590%, P < 0.0001, d = 2.4) and resulted in decreases in blood glucose AUC (-9.4%, P = 0.03, d = 0.56) and non-esterified fatty acid (NEFA) AUC (-27.3%, P = 0.023, d = 0.68) compared to placebo. No differences were found for plasma insulin AUC (P = 0.70) or gastric emptying estimated by co-ingested acetaminophen AUC (P = 0.96) between ketone and placebo. Overall, results indicate that KME supplementation attenuates postprandial glycemic and NEFA responses when taken 15 min prior to a mixed meal in young healthy individuals. Future studies are warranted to investigate whether KME supplementation may benefit individuals with impaired glycemic control. Novelty Bullets • Acute ketone monoester supplementation 15 min prior to a mixed meal decreased postprandial glucose and non-esterified fatty acid (NEFA) levels without significantly impacting postprandial insulin or estimates of gastric emptying. • Glucose and NEFA lowering effects of ketone monoester supplementation are apparently not mediated by changes in insulin release or gastric emptying.",2020,"KME supplementation acutely raised beta-hydroxybutyrate (β-OHB) AUC (590%, P < 0.0001, d = 2.4) and resulted in decreases in blood glucose AUC (-9.4%, P = 0.03, d = 0.56) and non-esterified fatty acid (NEFA) AUC (-27.3%, P = 0.023, d = 0.68) compared to placebo.","['Nineteen healthy young volunteers (10 males/9 females, 24.7 ± 4.9 years, BMI = 22.7 ± 2.4) participated in a double-blind', 'young healthy individuals']","['KME supplement or taste-matched placebo', 'placebo', 'KME supplementation', 'ketone monoester (KME']","['postprandial glycemic and NEFA responses', 'Novelty Bullets •', 'blood glucose AUC', 'mixed meal tolerance test (MMTT) glucose area under the curve (AUC', 'Blood samples', 'plasma insulin AUC', 'gastric emptying', 'postprandial glucose and non-esterified fatty acid (NEFA) levels', 'non-esterified fatty acid (NEFA) AUC', 'insulin release or gastric emptying', 'KME supplementation acutely raised beta-hydroxybutyrate (β-OHB) AUC']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0036071', 'cui_str': 'salicylamide'}]",19.0,0.104255,"KME supplementation acutely raised beta-hydroxybutyrate (β-OHB) AUC (590%, P < 0.0001, d = 2.4) and resulted in decreases in blood glucose AUC (-9.4%, P = 0.03, d = 0.56) and non-esterified fatty acid (NEFA) AUC (-27.3%, P = 0.023, d = 0.68) compared to placebo.","[{'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Greaves', 'Affiliation': 'The University of British Columbia Okanagan, 97950, Faculty of Medicine, Kelowna, British Columbia, Canada ; greaves.grant@gmail.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Xiang', 'Affiliation': 'The University of British Columbia Okanagan, 97950, Faculty of Medicine, Kelowna, British Columbia, Canada ; richard.xiang@alumni.ubc.ca.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rafiei', 'Affiliation': 'The University of British Columbia Okanagan, 97950, Kelowna, British Columbia, Canada ; hossein.rafiei5@gmail.com.'}, {'ForeName': 'Adeeb', 'Initials': 'A', 'LastName': 'Malas', 'Affiliation': 'The University of British Columbia Okanagan, 97950, Faculty of Medicine, Kelowna, British Columbia, Canada ; adib.malas@gmail.com.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'UBC Okanagan, School or Health and Exercise Sciences , 3333 University Way , Kelowna, British Columbia, Canada , V1V1V7 ; jonathan.little@ubc.ca.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0644']
3138,32941794,"Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


Unlike for extremity sarcomas, the efficacy of radiotherapy for retroperitoneal sarcoma is not established. The aim of this study was to evaluate the impact of preoperative radiotherapy plus surgery versus surgery alone on abdominal recurrence-free survival.
METHODS


EORTC-62092 is an open-label, randomised, phase 3 study done in 31 research institutions, hospitals, and cancer centres in 13 countries in Europe and North America. Adults (aged ≥18 years) with histologically documented, localised, primary retroperitoneal sarcoma that was operable and suitable for radiotherapy, who had not been previously treated and had a WHO performance status and American Society of Anesthesiologists score of 2 or lower, were centrally randomly assigned (1:1), using an interactive web response system and a minimisation algorithm, to receive either surgery alone or preoperative radiotherapy followed by surgery. Randomisation was stratified by hospital and performance status. Radiotherapy was delivered as 50·4 Gy (in 28 daily fractions of 1·8 Gy) in either 3D conformal radiotherapy or intensity modulated radiotherapy, and the objective of surgery was a macroscopically complete resection of the tumour mass with en-bloc organ resection as necessary. The primary endpoint was abdominal recurrence-free survival, as assessed by the investigator, and was analysed in the intention-to-treat population. Safety was analysed in all patients who started their allocated treatment. This trial is registered with ClinicalTrials.gov, NCT01344018.
FINDINGS


Between Jan 18, 2012 and April 10, 2017, 266 patients were enrolled, of whom 133 were randomly assigned to each group. The median follow-up was 43·1 months (IQR 28·8-59·2). 128 (96%) patients from the surgery alone group had surgery, and 119 (89%) patients in the radiotherapy and surgery group had both radiotherapy and surgery. Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95). The most common grade 3-4 adverse events were lymphopenia (98 [77%] of 127 patients in the radiotherapy plus surgery group vs one [1%] of 128 patients in the surgery alone group), anaemia (15 [12%] vs ten [8%]), and hypoalbuminaemia (15 [12%] vs five [4%]). Serious adverse events were reported in 30 (24%) of 127 patients in the radiotherapy plus surgery group, and in 13 (10%) of 128 patients in the surgery alone group. One (1%) of 127 patients in the radiotherapy plus surgery group died due to treatment-related serious adverse events (gastropleural fistula), and no patients in the surgery alone group died due to treatment-related serious adverse events.
INTERPRETATION


Preoperative radiotherapy should not be considered as standard of care treatment for retroperitoneal sarcoma.
FUNDING


European Organisation for Research and Treatment of Cancer, and European Clinical Trials in Rare Sarcomas.",2020,"Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95).","['Between Jan 18, 2012 and April 10, 2017, 266 patients were enrolled, of whom 133 were randomly assigned to each group', 'Adults (aged ≥18 years) with histologically documented, localised, primary retroperitoneal sarcoma that was operable and suitable for radiotherapy, who had not been previously treated and had a WHO performance status and American Society of Anesthesiologists score of 2 or lower', 'patients with primary retroperitoneal sarcoma (EORTC-62092', '31 research institutions, hospitals, and cancer centres in 13 countries in Europe and North America']","['interactive web response system and a minimisation algorithm, to receive either surgery alone or preoperative radiotherapy followed by surgery', 'Preoperative radiotherapy plus surgery versus surgery alone', '3D conformal radiotherapy or intensity modulated radiotherapy', 'Radiotherapy', 'radiotherapy', 'preoperative radiotherapy plus surgery versus surgery alone']","['Safety', 'lymphopenia', 'Serious adverse events', 'anaemia', 'Median abdominal recurrence-free survival', 'abdominal recurrence-free survival']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0585129', 'cui_str': 'Retroperitoneal sarcoma'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",266.0,0.228048,"Median abdominal recurrence-free survival was 4·5 years (95% CI 3·9 to not estimable) in the radiotherapy plus surgery group and 5·0 years (3·4 to not estimable) in the surgery only group (hazard ratio 1·01, 95% CI 0·71-1·44; log rank p=0·95).","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Surgical Oncology, Institut Curie, Université Paris Sciences et Lettres, Paris, France. Electronic address: sylvie.bonvalot@curie.fr.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Le Péchoux', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Swallow', 'Affiliation': 'Department of Surgical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Strauss', 'Affiliation': 'Department of Surgical Oncology, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meeus', 'Affiliation': 'Department of Surgical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'van Coevorden', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stoldt', 'Affiliation': 'Department of Surgical Oncology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Stoeckle', 'Affiliation': 'Department of Surgical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rastrelli', 'Affiliation': 'Department of Surgery, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Chandrajit P', 'Initials': 'CP', 'LastName': 'Raut', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Hompes', 'Affiliation': 'Department of Surgical Oncology, University Hospitals Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'De Paoli', 'Affiliation': 'Centro di Riferimento Oncologico CRO-IRCCS, Aviano, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sangalli', 'Affiliation': 'Department of Radiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Honoré', 'Affiliation': 'Department of Surgical Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chung', 'Affiliation': 'Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Miah', 'Affiliation': 'Department of Radiation Oncology, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Jean Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Stelmes', 'Affiliation': 'Quality Assurance in Radiotherapy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Angelo P', 'Initials': 'AP', 'LastName': 'Dei Tos', 'Affiliation': 'Department of Medicine, University of Padua School of Medicine, Padua, Italy.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Baldini', 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital, Boston, MA, USA; Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'Department of Statistics, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'Headquarters, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Rick L', 'Initials': 'RL', 'LastName': 'Haas', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30446-0']
3139,32941801,Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly.,"BCG vaccination in children protects against heterologous infections and improves survival independently of tuberculosis prevention. The phase III ACTIVATE trial assessed whether BCG has similar effects in the elderly. In this double-blind, randomized trial, elderly patients (n = 198) received BCG or placebo vaccine at hospital discharge and were followed for 12 months for new infections. At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo). The incidence of new infections was 42.3% (95% CIs 31.9%-53.4%) after placebo vaccination and 25.0% (95% CIs 16.4%-36.1%) after BCG vaccination; most of the protection was against respiratory tract infections of probable viral origin (hazard ratio 0.21, p = 0.013). No difference in the frequency of adverse effects was found. Data show that BCG vaccination is safe and can protect the elderly against infections. Larger studies are needed to assess protection against respiratory infections, including COVID-19 (ClinicalTrials.gov NCT03296423).",2020,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","['elderly patients (n\xa0= 198) received', 'Elderly']","['BCG', 'BCG vaccination', 'Activate', 'BCG or placebo vaccine']","['frequency of adverse effects', 'incidence of new infections', 'time to first infection']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0199804', 'cui_str': 'BCG vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439633', 'cui_str': 'New infection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.444856,"At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo).","[{'ForeName': 'Evangelos J', 'Initials': 'EJ', 'LastName': 'Giamarellos-Bourboulis', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece. Electronic address: egiamarel@med.uoa.gr.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsilika', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Moorlag', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Antonakos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antigone', 'Initials': 'A', 'LastName': 'Kotsaki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Domínguez-Andrés', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Evdoxia', 'Initials': 'E', 'LastName': 'Kyriazopoulou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Gkavogianni', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Maria-Evangelia', 'Initials': 'ME', 'LastName': 'Adami', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Damoraki', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Koufargyris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Karageorgos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Bolanou', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Koenen', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands.'}, {'ForeName': 'Dionyssia-Irene', 'Initials': 'DI', 'LastName': 'Droggiti', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Renieris', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Papadopoulos', 'Affiliation': '4(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, 6500 Nijmegen, the Netherlands; Department of Immunology and Metabolism, Life & Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.'}]",Cell,['10.1016/j.cell.2020.08.051']
3140,32941872,Regional variation in patients and outcomes in the GLOBAL LEADERS trial.,"BACKGROUND


Despite the overall neutral results of the GLOBAL-LEADERS trial, results from a prespecified subgroup analysis showed that patients from Western Europe had a significantly lower rate of the primary endpoint when treated with ticagrelor monotherapy. Therefore, we aimed to examine the regional disparities in patients' baseline characteristics and their response to ticagrelor monotherapy.
METHODS


Patients' baseline characteristics and the treatment effects of ticagrelor combined with aspirin for 1 month, followed by ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT) were compared according to participating countries. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at two years.
RESULTS


Significant variances in patients' baseline characteristics were found between participating countries. The primary endpoint varied significantly according to the country (P interaction  = 0.027). Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI: 0.13-0.73) and The Netherlands (2.4% versus 4.8%, HR, 0.50, 95%CI: 0.26-0.94) had lower rates of the primary endpoint when allocated to ticagrelor monotherapy, compared with the standard DAPT regimen. Of the 26 baseline and post-randomization factors explored, variance in the rate of complex PCI between countries was identified as the top contributor to this regional interaction.
CONCLUSIONS


Patients' baseline characteristics varied between participating countries in the GLOBAL-LEADERS trial. There is a significant regional variance in the treatment effect of ticagrelor monotherapy, which could partly be explained by the differences in complex PCI being performed.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov (NCT01813435).",2020,"Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI:",[],"['ticagrelor combined with aspirin', '95%CI', 'ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT', 'ticagrelor monotherapy']",['composite endpoint of all-cause death or new Q-wave myocardial infarction at two years'],[],"[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.539715,"Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI:","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland Galway, Galway, Ireland.""}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland; Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland Galway, Galway, Ireland.""}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland; Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland; Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, Institute of Cardiology, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': 'Department of Cardiology, Rheinland Klinikum Neuss, Lukaskrankenhaus, Neuss, Germany.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, French Alliance for Cardiovascular Trials, Hôpital Bichat, AP-HP, Université Paris-Diderot, INSERM U-1148, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': ""Department of Cardiology, Xijing hospital, Xi'an, China.""}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland; NHLI, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.039']
3141,32941917,Low dose IL-2 for treating moderate to severe alopecia areata. A 52 weeks multicenter prospective placebo-controlled study assessing its impact on T regulatory cells and natural killer populations.,,2020,,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0293259,,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Le Duff', 'Affiliation': ""Université Côte d'Azur. Centre Hospitalier Universitaire Nice, Department of Dermatology. Nice, France.""}, {'ForeName': 'Jean-David', 'Initials': 'JD', 'LastName': 'Bouaziz', 'Affiliation': 'Hôpital Saint-Louis et Université de Paris. Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Université Côte d'Azur, Centre Hospitalier Universitaire Nice. Délégation à la Recherche Clinique et à l'Innovation. Nice, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ticchioni', 'Affiliation': ""Université Côte d'Azur. Centre Hospitalier Universitaire Nice, Department of Dermatology. Nice, France.""}, {'ForeName': 'Manuelle', 'Initials': 'M', 'LastName': 'Viguier', 'Affiliation': 'Centre Hospitalier Universitaire Reims. Department of Dermatology-Venereology. Reims, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dereure', 'Affiliation': 'Department of Dermatology and INSERM1058 « Pathogenesis and control of chronic infections », University of Montpellier, Montpellier, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Reygagne', 'Affiliation': 'Hôpital Saint-Louis et Université de Paris. Paris, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Montaudié', 'Affiliation': ""Université Côte d'Azur. Centre Hospitalier Universitaire Nice, Department of Dermatology. Nice, France.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Université Côte d'Azur. Centre Hospitalier Universitaire Nice, Department of Dermatology. Nice, France.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Monestier', 'Affiliation': 'Assistance Publique des Hôpitaux de Marseille. Department of Dermatology. Marseille, France.'}, {'ForeName': 'Marie-Aleth', 'Initials': 'MA', 'LastName': 'Richard', 'Affiliation': 'CEReSS-EA 3279, Research Centrer in Health Services and Quality of Life Aix Marseille University, Dermatology Department, Universitary Hospital Timone, Assistance Publique Hôpitaux de Marseille, APHM, 13385, Marseille, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Université Côte d'Azur. Centre Hospitalier Universitaire Nice, Department of Dermatology. Nice, France; Université Côte d'Azur, Inserm U1065, Team 12, C3M, Nice, France. Electronic address: passeron@unice.fr.""}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.08.015']
3142,32949011,"Oral Administration of Live and Dead Cells of Lactobacillus sakei proBio65 Alleviated Atopic Dermatitis in Children and Adolescents: a Randomized, Double-Blind, and Placebo-Controlled Study.","Several studies suggest that probiotics might be useful in the management of atopic dermatitis (AD). However, the efficacy and comparison between both the administration of viable and non-viable probiotics on alleviation of AD is not well studied. Therefore, the purpose of this study was to evaluate the effect of L. sakei proBio65 live and dead cells when administered (1 × 10 10  cells/day) for 12 weeks to children and adolescents (aged 3 to 18) with atopic dermatitis. In this randomized double-blind, placebo-controlled study, ninety patients were recruited and randomly allocated to either the L. sakei proBio65 live cells, L. sakei proBio65 dead cells, or placebo groups. Assessment of efficacy was based on the change in SCORing Atopic Dermatitis (SCORAD) score, Investigators Global Assessment (IGA) score, serum inflammatory markers such as the serum eosinophil (count), IgE, eosinophil cationic protein (ECP), CCL17 (thymus and activation-regulated chemokine [TARC]), and CCL27 (cutaneous T cell-attracting chemokine [CTACK]), and changes in skin condition (moisture and sebum) at baseline, week 6 and week 12. The SCORAD total score decreased in the live cells (p = 0.0015) and dead cell group (p = 0.0017) from the baseline after 12 weeks, whereas there were no significant changes in the placebo group when compared with baseline. The skin sebum content increased in both the live cell (p < 0.0001) and the dead cell group (p < 0.0001), suggesting potential improvements in skin barrier functions. Current data suggested a positive improvement in alleviation of AD symptoms upon oral administration of L. sakei proBio65 in both viable and non-viable forms.",2020,"The SCORAD total score decreased in the live cells (p = 0.0015) and dead cell group (p = 0.0017) from the baseline after 12 weeks, whereas there were no significant changes in the placebo group when compared with baseline.","[' ninety patients', 'children and adolescents (aged 3 to 18) with atopic dermatitis', 'Children and Adolescents']","['L. sakei proBio65 live cells, L. sakei proBio65 dead cells, or placebo', 'placebo', 'sakei', 'Live and Dead Cells of Lactobacillus sakei proBio65', 'Placebo']","['SCORing Atopic Dermatitis (SCORAD) score, Investigators Global Assessment (IGA) score, serum inflammatory markers such as the serum eosinophil (count), IgE, eosinophil cationic protein (ECP), CCL17 (thymus and activation-regulated chemokine [TARC]), and CCL27 (cutaneous T cell-attracting chemokine [CTACK]), and changes in skin condition (moisture and sebum', 'SCORAD total score', 'skin barrier functions', 'skin sebum content', 'Atopic Dermatitis']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317639', 'cui_str': 'Lactobacillus sakei'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0950373', 'cui_str': 'Eosinophilic cationic protein'}, {'cui': 'C0539535', 'cui_str': 'CCL17 protein, human'}, {'cui': 'C0768285', 'cui_str': 'CCL27 protein, human'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",90.0,0.328581,"The SCORAD total score decreased in the live cells (p = 0.0015) and dead cell group (p = 0.0017) from the baseline after 12 weeks, whereas there were no significant changes in the placebo group when compared with baseline.","[{'ForeName': 'Irfan A', 'Initials': 'IA', 'LastName': 'Rather', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Byung-Chun', 'Initials': 'BC', 'LastName': 'Kim', 'Affiliation': 'Probionic Corporation, Jeonbuk Institute for Food-Bioindustry, Jeonju, South Korea.'}, {'ForeName': 'Lee-Ching', 'Initials': 'LC', 'LastName': 'Lew', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Seong-Kwan', 'Initials': 'SK', 'LastName': 'Cha', 'Affiliation': 'Hansung Food Co., Ltd, Bucheon, South Korea.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Probionic Corporation, Jeonbuk Institute for Food-Bioindustry, Jeonju, South Korea.'}, {'ForeName': 'Gyeong-Jun', 'Initials': 'GJ', 'LastName': 'Nam', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Rajib', 'Initials': 'R', 'LastName': 'Majumder', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea.'}, {'ForeName': 'Jeongheui', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'National Science Museum, Ministry of Science, ICT and Future Planning, Daejeon, South Korea.'}, {'ForeName': 'Seul-Ki', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Oracle Dermatologic Clinic, Sejong, South Korea.'}, {'ForeName': 'Young-Joon', 'Initials': 'YJ', 'LastName': 'Seo', 'Affiliation': 'Department of Dermatology, School of Medicine, Chungnam National University, Daejeon, South Korea. joon@cnu.ac.kr.'}, {'ForeName': 'Yong-Ha', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'College of Life and Applied Sciences, Yeungnam University, Gyeongsan, South Korea. peter@ynu.ac.kr.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-020-09654-7']
3143,32949027,Role of CaMKII and sarcolipin in muscle adaptations to strength training with different levels of fatigue in the set.,"Strength training promotes a IIX-to-IIA shift in myosin heavy chain (MHC) composition, likely due to changes in sarcoplasmic [Ca 2+  ] which are sensed by CaMKII. Sarcoplasmic [Ca 2+  ] is in part regulated by sarcolipin (SLN) a small protein, that when overexpressed in rodents stimulates mitochondrial biogenesis and a fast-to-slow fibre type shift. The purpose of this study was to determine whether CaMKII and SLN are involved in muscle phenotype and performance changes elicited by strength training. Twenty-two men followed an 8-week velocity-based resistance training programme using the full squat exercise while monitoring repetition velocity. Subjects were randomly assigned to two resistance training programmes differing in the repetition velocity loss allowed in each set: 20% (VL20) vs 40% (VL40). Strength training caused muscle hypertrophy, improved 1RM and increased total CaMKII protein expression, particularly of the δ D  isoform. Phospho-Thr 287  -CaMKII δ D  expression increased only in VL40 (+89%), which experienced greater muscle hypertrophy, and a reduction in MHC-IIX percentage. SLN expression was increased in VL20 (+33%) remaining unaltered in VL40. The changes in phospho-Thr 287  -CaMKII δ D  were positively associated with muscle hypertrophy and the number of repetitions during training, and negatively with the changes in MHC-IIX and SLN. Most OXPHOS proteins remained unchanged, except for NDUFB8 (Complex I), which was reduced after training (-22%) in both groups. The amount of fatigue allowed in each set critically influences muscle CaMKII and SLN responses and determines muscle phenotype changes. With lower intra-set fatigue, the IIX-to-IIA MHC shift is attenuated.",2020,"Strength training caused muscle hypertrophy, improved 1RM and increased total CaMKII protein expression, particularly of the δ D  isoform.",['Twenty-two men followed an'],"['Strength training', '8-week velocity-based resistance training programme using the full squat exercise while monitoring repetition velocity', 'Sarcoplasmic ', 'CaMKII and SLN', 'CaMKII and sarcolipin']","['SLN expression', 'muscle hypertrophy, improved 1RM and increased total CaMKII protein expression', 'repetition velocity loss', 'muscle hypertrophy and the number of repetitions during training, and negatively with the changes in MHC-IIX and SLN']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0248868', 'cui_str': 'Calmodulin-Dependent Protein Kinase II'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0654533', 'cui_str': 'sarcolipin'}]","[{'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0248868', 'cui_str': 'Calmodulin-Dependent Protein Kinase II'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}]",,0.022455,"Strength training caused muscle hypertrophy, improved 1RM and increased total CaMKII protein expression, particularly of the δ D  isoform.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Martinez-Canton', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Gallego-Selles', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Gelabert-Rebato', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Martin-Rincon', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodriguez-Rosell', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morales-Alamo', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Sanchis-Moysi', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dorado', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Gonzalez-Badillo', 'Affiliation': 'Physical Performance & Sports Research Center, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'Jose A L', 'Initials': 'JAL', 'LastName': 'Calbet', 'Affiliation': 'Department of Physical Education Campus Universitario de Tafira s/n, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35017, Spain.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13828']
3144,32949091,Effects of Branched-chain Amino Acids on Postoperative Tumor Recurrence in Patients Undergoing Curative Resection for Hepatocellular Carcinoma: A Randomized Clinical Trial.,"BACKGROUND


No effective postoperative adjuvant therapies have been established for patients with hepatocellular carcinoma (HCC). The aim of this study was to investigate the effect of oral administration of branched-chain amino acids (BCAA) on the recurrence-free survival (RFS) after hepatic resection in HCC patients.
METHODS


In this randomized clinical trial, HCC patients undergoing curative resections were randomly assigned in a 1:1 ratio to the BCAA group or surgery-alone group. The BCAA group received BCAA (Livact ®  ) for up to 4 years. The primary endpoint was the RFS. The secondary endpoint was the overall survival (OS). Multivariate analysis was performed to detect the clinical characteristics significantly associated with RFS.
RESULTS


Between January 2010 and October 2014, 156 patients (75 in BCAA group and 81 in surgery-alone group) were enrolled in the study. Of these, 2 patients were excluded from the efficacy analysis. Comparison of the survival curves by the log rank test demonstrated no significant difference in the RFS (P=0.579) or OS (P=0.268) between the BCAA and the control group. Multivariate analysis revealed that the RFS was significantly associated with age and number of tumors. A beneficial effect of BCAA on the RFS was found in patients younger than 72 years old with a HbA1c level of <6.4%.
CONCLUSIONS


Oral BCAA supplementation could not reduce the risk of recurrence after hepatic resection in HCC patients; however, the results suggested that BCAA supplementation may be beneficial for selected patients who were younger and had mildly impaired glucose tolerance.",2020,Comparison of the survival curves by the log rank test demonstrated no significant difference in the RFS (P=0.579) or OS (P=0.268) between the BCAA and the control group.,"['patients younger than 72 years old with a HbA1c level of <6.4', 'Between January 2010 and October 2014, 156 patients (75 in BCAA group and 81 in surgery-alone group) were enrolled in the study', 'HCC patients', 'Patients Undergoing Curative Resection for Hepatocellular Carcinoma', 'selected patients who were younger and had mildly impaired glucose tolerance', 'patients with hepatocellular carcinoma (HCC', 'HCC patients undergoing curative resections']","['branched-chain amino acids (BCAA', 'BCAA group or surgery-alone group', 'Branched-chain Amino Acids', 'BCAA supplementation', 'BCAA', 'BCAA (Livact ®  ']","['overall survival (OS', 'recurrence-free survival (RFS', 'risk of recurrence', 'survival curves', 'Postoperative Tumor Recurrence', 'RFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0556085', 'cui_str': 'Branched chain amino acid supplementation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0521158', 'cui_str': 'Recurrent tumor'}]",,0.152532,Comparison of the survival curves by the log rank test demonstrated no significant difference in the RFS (P=0.579) or OS (P=0.268) between the BCAA and the control group.,"[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hachiya', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Iso', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Tago', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Kyung Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Yuhki', 'Initials': 'Y', 'LastName': 'Sakuraoka', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Shiraki', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.'}]",Journal of hepato-biliary-pancreatic sciences,['10.1002/jhbp.830']
3145,32949103,Early access to antiretroviral therapy versus standard of care among HIV-positive participants in Eswatini in the public health sector: the MaxART stepped-wedge randomized controlled trial.,"INTRODUCTION


The WHO recommends antiretroviral treatment (ART) for all HIV-positive patients regardless of CD4 count or disease stage, referred to as ""Early Access to ART for All"" (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government-managed public health system with the aim to examine the ""real world"" impact of EAAA on care retention and viral suppression.
METHODS


In this stepped-wedge randomized controlled trial, 14 public sector health facilities in Eswatini were paired and randomly assigned to stepwise transition from standard of care (SoC) to EAAA. ART-naïve participants ≥18 years who were not pregnant or breastfeeding were eligible for enrolment. We used Cox proportional hazard models with censoring at clinic transition to estimate the effects of EAAA on retention in care and retention and viral suppression combined.
RESULTS


Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12-month HIV care retention rates were 80% (95% CI: 77 to 83) and 86% (95% CI: 83 to 88). The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA. EAAA increased both retention (HR: 1·60, 95% CI: 1·15 to 2·21, p = 0.005) and retention and viral suppression combined (HR: 4.88, 95% CI: 2.96 to 8.05, p < 0.001). We also identified significant gaps in current health systems ability to provide viral load (VL) monitoring with 80% participants in SoC and 66% in EAAA having a missing VL at last contact.
CONCLUSIONS


The observed improvement in retention in care and on the combined retention and viral suppression provides an important co-benefit of EAAA to HIV-positive adults themselves, at least in the short term. Our results from this ""real world"" health systems trial strongly support EAAA for Eswatini and countries with similar HIV epidemics and health systems. VL monitoring needs to be scaled up for appropriate care management.",2020,The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA.,"['14 public sector health facilities in Eswatini', '3405 participants were enrolled', 'ART-naïve participants ≥18\xa0years who were not pregnant or breastfeeding were eligible for enrolment', 'Between September 2014 and August 2017', 'HIV-positive participants in Eswatini in the public health sector']","['antiretroviral therapy versus standard of care', 'stepwise transition from standard of care (SoC) to EAAA']","['retention and viral suppression', 'retention (HR', '12-month HIV care retention rates', '12-month combined retention and viral suppression endpoint rates']","[{'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",3405.0,0.295478,The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA.,"[{'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Center on Methods for Implementation and Prevention Science and Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Boston, MA, USA.'}, {'ForeName': 'Sikhatele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Swaziland.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Pasipamire', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Swaziland.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Chai', 'Affiliation': 'Department of Nutrition, Harvard T.H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Reis', 'Affiliation': 'Leiden University Medical Center, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Delva', 'Affiliation': 'The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Khumalo', 'Affiliation': 'Eswatini National Network of People Living with HIV (SWANNEPHA), Mbabane, Swaziland.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Zwane', 'Affiliation': 'SAfAIDS, Manzini, Swaziland.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Fleming', 'Affiliation': 'aidsfonds, Amsterdam, the Netherlands.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Chao', 'Affiliation': 'Center on Methods for Implementation and Prevention Science and Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Public Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Directorate Office, Ministry of Health, Mbabane, Swaziland.'}]",Journal of the International AIDS Society,['10.1002/jia2.25610']
3146,32947558,Population Pharmacokinetic Modeling of Vancomycin in Thai Patients with Heterogeneous and Unstable Renal Function.,"BACKGROUND


Vancomycin is widely used to treat gram-positive bacterial infections. However, given significant interpatient variability in its pharmacokinetics, maintaining plasma concentrations is difficult within its characteristically narrow therapeutic window. This is especially challenging in patients with unstable renal function. Thus, the aim of this study was to develop a population pharmacokinetic model for vancomycin that is suitable for Thai patients with variable renal functions, including those with unstable renal function.
METHODS


Data from 213 patients, including 564 blood samples, were retrospectively collected; approximately 70% patients exhibited unstable renal function during vancomycin treatment. The model building group was randomly assigned 108 patients and the remaining 33 patients comprised the validation group. A population pharmacokinetic model was developed that incorporated drug clearance (CL) as a function of time-varying creatine clearance (CrCL). The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
RESULTS


A two-compartment model with drug CL values that changed with time-varying CrCL adequately described vancomycin pharmacokinetics in the evaluated heterogeneous patient population with unstable renal function. Vancomycin CL was related to time-varying CrCL as follows: CL(t)=0.11+0.021×CrCL(t) (CrCL < 120 mL/min). Using the population model, Bayesian estimation with at least one measured serum concentration resulted in a forecasting error of small bias (-2.4%) and adequate precision (31.5%).
CONCLUSION


In hospitals with a high incidence of unstable renal function, incorporating time-varying CrCL with Bayesian estimation and at least one measured drug concentration, along with frequent CrCL monitoring, improves the predictive performance of therapeutic drug monitoring of vancomycin.",2020,"The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
","['Thai Patients with Heterogeneous and Unstable Renal Function', 'heterogeneous patient population with unstable renal function', 'patients with unstable renal function', 'Data from 213 patients, including 564 blood samples, were retrospectively collected; approximately 70% patients exhibited unstable renal function during vancomycin treatment', 'Thai patients with variable renal functions, including those with unstable renal function']","['Vancomycin CL', 'Vancomycin', 'vancomycin']",[],"[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",[],108.0,0.0230478,"The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
","[{'ForeName': 'Siriluk', 'Initials': 'S', 'LastName': 'Jaisue', 'Affiliation': 'Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Cholatip', 'Initials': 'C', 'LastName': 'Pongsakul', 'Affiliation': '(Certificate Board of Nephrology), Division of Nephrology, Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': ""D'Argenio"", 'Affiliation': 'Biomedical Simulations Resource, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Pakawadee', 'Initials': 'P', 'LastName': 'Sermsappasuk', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000801']
3147,32947568,Effect of β-Alanine Supplementation on Monocyte Recruitment and Cognition During a 24-Hour Simulated Military Operation.,"Wells, AJ, Varanoske, AN, Coker, NA, Kozlowski, GJ, Frosti, CL, Boffey, D, Harat, I, Jahani, S, Gepner, Y, and Hoffman, JR. Effect of β-alanine supplementation on monocyte recruitment and cognition during a 24-hour simulated military operation. J Strength Cond Res XX(X): 000-000, 2020-Sustained military operations (SUSOPs) result in psychological stress and cognitive dysfunction, which may be related to the recruitment of classical monocytes into the brain. This study examined the effect of beta-alanine (BA) on cognition and monocyte recruitment during a simulated 24-hour SUSOP. Nineteen healthy men ingested 12-g/d BA or placebo for 14 days before an SUSOP. Monocyte chemoattractant protein-1 (MCP-1), C-C chemokine receptor-2 (CCR2), and macrophage-1-antigen (CD11b) expression were assessed through multiplex assay and flow cytometry. Psychological stress and cognition were assessed through Automated Neuropsychological Assessment Metrics (ANAM). A composite measure of cognition (COGcomp) was generated from throughput scores extracted from 7 ANAM cognitive tests. Assessments occurred at baseline (0H), 12 hours (12H), 18 hours (18H), and 24 hours (24H). Significance was accepted at p ≤ 0.05. No significant effect of BA was noted for any variable (p's > 0.05). The frequency and severity of symptoms of psychological stress increased significantly at 18 and 24H compared with 0 and 12H (p's < 0.05). COGcomp decreased significantly at 18 and 24H compared with 0 and 12H (p's ≤ 0.001). MCP-1 peaked at 18H was significantly lower at 24H compared with 18H but remained elevated at 24H compared with 0H (p's < 0.001). CCR2 expression was significantly lower at 12 (p = 0.031), 18, and 24H (p's < 0.001). CD11b expression was significantly higher at 12H (p = 0.039) and 24H (p's = 0.003). MCP-1 was negatively associated with COGcomp (β = -0.395, p = 0.002, r2 = 0.174). Neither CCR2 or CD11b was related to COGcomp (p's > 0.05). Cognitive dysfunction during SUSOPs is related to serum concentrations of MCP-1 but is not influenced by BA supplementation.",2020,MCP-1 peaked at 18H was significantly lower at 24H compared with 18H but remained elevated at 24H compared with 0H (,['Nineteen healthy men ingested 12-g/d BA or'],"['2020-Sustained military operations (SUSOPs', 'J Strength Cond Res XX(X', 'β-alanine supplementation', 'placebo', 'beta-alanine (BA', 'β-Alanine Supplementation']","['cognition and monocyte recruitment', 'COGcomp', 'Monocyte Recruitment and Cognition', 'Psychological stress and cognition', 'cognition (COGcomp', 'MCP-1', 'CCR2 expression', 'frequency and severity of symptoms of psychological stress', 'Cognitive dysfunction', 'Monocyte chemoattractant protein-1', 'BA', 'Wells, AJ, Varanoske, AN, Coker, NA, Kozlowski, GJ, Frosti, CL, Boffey, D, Harat, I, Jahani, S, Gepner, Y, and Hoffman, JR', 'MCP-1), C-C chemokine receptor-2 (CCR2), and macrophage-1-antigen (CD11b) expression', 'CCR2 or CD11b', 'CD11b expression']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1318183', 'cui_str': '12G'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0000392', 'cui_str': 'beta-Alanine'}, {'cui': 'C0205170', 'cui_str': 'Good'}, {'cui': 'C0282552', 'cui_str': 'beta-Chemokines'}, {'cui': 'C0079785', 'cui_str': 'Receptor, Complement 3'}, {'cui': 'C1136310', 'cui_str': 'Lymphocyte antigen CD11b'}]",19.0,0.0411827,MCP-1 peaked at 18H was significantly lower at 24H compared with 18H but remained elevated at 24H compared with 0H (,"[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Wells', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Varanoske', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Coker', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Kozlowski', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Cheyanne L', 'Initials': 'CL', 'LastName': 'Frosti', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boffey', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Harat', 'Affiliation': 'Institute of Exercise Physiology & Rehabilitation Science, College of Health Professions and Sciences, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Jahani', 'Affiliation': 'Accreditation, Assessment and Analytics, College of Community Innovation and Education, University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, and Sylvan Adams Sports Institute, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Hoffman', 'Affiliation': 'Department of Molecular Biology, Ariel University, Ariel, Israel.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003809']
3148,32947569,"Effects of Resistance Training at Different Loads on Inflammatory Biomarkers, Muscle Mass, Muscular Strength, and Physical Performance in Postmenopausal Women.","Carneiro, MAS, de Oliveira Júnior, GN, de Sousa, JFR, Murta, EFC, Orsatti, CL, Michelin, MA, Cyrino, ES, and Orsatti, FL. Effects of resistance training at different loads on inflammatory biomarkers, muscle mass, muscular strength, and physical performance in postmenopausal women. J Strength Cond Res XX(X): 000-000, 2020-It has been suggested that the effect of resistance training (RT) on circulating proinflammatory biomarkers may be dependent on muscle mass gain. A few recent studies have suggested that lower-load RT (LLRT; loads <50% of 1 repetition maximum [1RM] and repetition performed until, or close to, voluntary concentric failure) may be superior to higher-load RT (HLRT; loads >70% of 1RM) in increasing muscle mass. Hence, this study aimed to test whether LLRT is superior to HLRT for increasing muscle mass (total fat-free mass [TFFM] and leg fat-free mass [LFFM]) and improving circulating inflammatory biomarkers (interleukin [IL]-6, IL1-ra, tumor necrosis factor [TNF]-α, and extracellular heat shock protein [eHSP]70) in postmenopausal women (PW) (primary outcome). The secondary outcome was to compare the changes in muscular strength and physical performance (4-meter walking test [4-M], timed-up-and-go [TUG] test, and sit-to-stand [STS] test) between the LLRT and HLRT. The PW were randomized into 2 groups: LLRT (n = 14; loads necessary to perform 30-35 repetitions) and HLRT (n = 15; loads necessary to perform 8-12 repetitions). The greater magnitude of increase in LFFM (p = 0.033) was observed in LLRT when compared with HLRT. Moreover, there was a trend for a greater increase in TFFM in LLRT over HLRT (p = 0.070). However, there were similar improvements in TNF-α and muscular strength (p < 0.001). Furthermore, there was no significant difference between the RT schemes on IL-6, IL-1ra, and eHSP70 levels. Thus, although performing LLRT until, or close to, voluntary concentric failure seems to provide a greater stimulus for an increase in muscle mass than HLRT, it does not seem to affect the responses in circulating inflammatory biomarkers, muscular strength, and physical performance in PW.",2020,"Furthermore, there was no significant difference between the RT schemes on IL-6, IL-1ra, and eHSP70 levels.","['Postmenopausal Women', 'postmenopausal women (PW) (primary outcome', 'postmenopausal women']","['Resistance Training', 'resistance training', 'HLRT', 'resistance training (RT', 'LLRT']","['TNF-α and muscular strength', 'LFFM', 'muscular strength and physical performance (4-meter walking test [4-M], timed-up-and-go [TUG] test, and sit-to-stand [STS] test', 'IL-6, IL-1ra, and eHSP70 levels', 'Inflammatory Biomarkers, Muscle Mass, Muscular Strength, and Physical Performance', 'circulating inflammatory biomarkers, muscular strength, and physical performance', 'inflammatory biomarkers, muscle mass, muscular strength, and physical performance', 'TFFM']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",,0.0279585,"Furthermore, there was no significant difference between the RT schemes on IL-6, IL-1ra, and eHSP70 levels.","[{'ForeName': 'Marcelo A S', 'Initials': 'MAS', 'LastName': 'Carneiro', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Gersiel N', 'Initials': 'GN', 'LastName': 'de Oliveira Júnior', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Jairo F R', 'Initials': 'JFR', 'LastName': 'de Sousa', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Eddie F C', 'Initials': 'EFC', 'LastName': 'Murta', 'Affiliation': 'Oncology Research Institute (IPON), Gynecology and Obstetrics Program, Federal University of Triangulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Claudio L', 'Initials': 'CL', 'LastName': 'Orsatti', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Márcia A', 'Initials': 'MA', 'LastName': 'Michelin', 'Affiliation': 'Oncology Research Institute (IPON), Gynecology and Obstetrics Program, Federal University of Triangulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Paraná, Brazil.'}, {'ForeName': 'Fábio L', 'Initials': 'FL', 'LastName': 'Orsatti', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003768']
3149,32949140,"A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren's syndrome.","OBJECTIVES


This phase 2 proof-of-concept study (NCT02610543) assessed efficacy, safety and effects on salivary gland inflammation of seletalisib, a potent and selective PI3Kδ inhibitor, in patients with moderate-to-severe primary Sjögren's syndrome (PSS).
METHODS


Adults with PSS were randomized 1:1 to seletalisib 45 mg/day or placebo, in addition to current PSS therapy. Primary end points were safety and tolerability and change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at week 12. Secondary end points included change from baseline at week 12 in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score and histological features in salivary gland biopsies.
RESULTS


Twenty-seven patients were randomized (seletalisib n = 13, placebo n = 14); 20 completed the study. Enrolment challenges led to early study termination with loss of statistical power (36% vs 80% planned). Nonetheless, a trend for improvement in ESSDAI and ESSPRI [difference vs placebo: -2.59 (95% CI: -7.30, 2.11; P=0.266) and -1.55 (95% CI: -3.39, 0.28), respectively] was observed at week 12. No significant changes were seen in saliva and tear flow. Serious adverse events (AEs) were reported in 3/13 of patients receiving seletalisib vs 1/14 for placebo and 5/13 vs 1/14 discontinued due to AEs, respectively. Serum IgM and IgG concentrations decreased in the seletalisib group vs placebo. Seletalisib demonstrated efficacy in reducing size and organisation of salivary gland inflammatory foci and in target engagement, thus reducing PI3K-mTOR signalling compared with placebo.
CONCLUSION


Despite enrolment challenges, seletalisib demonstrated a trend towards clinical improvement in patients with PSS. Histological analyses demonstrated encouraging effects of seletalisib on salivary gland inflammation and organisation.
TRIAL REGISTRATION


https://clinicaltrials.gov, NCT02610543.",2020,"Seletalisib demonstrated efficacy in reducing size and organisation of salivary gland inflammatory foci and in target engagement, thus reducing PI3K-mTOR signalling compared with placebo.
","[""primary Sjögren's syndrome"", 'patients with PSS', 'Twenty-seven patients were randomized (seletalisib n\u2009=\u200913, placebo n\u2009=\u200914); 20 completed the study', 'Adults with PSS', ""patients with moderate-to-severe primary Sjögren's syndrome (PSS""]","['seletalisib 45\u2009mg/day or placebo, in addition to current PSS therapy', 'placebo', 'oral seletalisib']","[""change from baseline at week 12 in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score and histological features in salivary gland biopsies"", ""safety and tolerability and change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score"", 'salivary gland inflammation and organisation', 'Serious adverse events (AEs', 'saliva and tear flow', 'ESSDAI and ESSPRI', 'Serum IgM and IgG concentrations']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C4507489', 'cui_str': 'seletalisib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4507489', 'cui_str': 'seletalisib'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0193303', 'cui_str': 'Biopsy of salivary gland'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037023', 'cui_str': 'Sialoadenitis'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",27.0,0.696523,"Seletalisib demonstrated efficacy in reducing size and organisation of salivary gland inflammatory foci and in target engagement, thus reducing PI3K-mTOR signalling compared with placebo.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Juarez', 'Affiliation': 'Translational Medicine, UCB Pharma, Slough.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Diaz', 'Affiliation': 'Translational Medicine, UCB Pharma, Slough.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Johnston', 'Affiliation': 'Translational Medicine, UCB Pharma, Slough.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Nayar', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Payne', 'Affiliation': 'Discovery Biology.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Helmer', 'Affiliation': 'Quantitative Clinical Pharmacology.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Cain', 'Affiliation': 'Global Clinical Sciences and Operations, UCB Pharma, Slough, UK.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'Statistical Science and Innovation, UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Devauchelle-Pensec', 'Affiliation': 'Department of Rheumatology, Brest University, Cavale Blanche Hospital, Brest, France.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Giacomelli', 'Affiliation': ""Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Jacques-Eric', 'Initials': 'JE', 'LastName': 'Gottenberg', 'Affiliation': 'Department of Rheumatology, National Reference Centre For Rare Systemic Auto-Immune Diseases, Strasbourg University Hospital, University of Strasbourg, IBMC, CNRS UPR 3572, Strasbourg, France.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Guggino', 'Affiliation': 'Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, Rheumatology Section, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kvarnström', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Université Paris-Saclay, INSERM, CEA, Centre de recherche en Immunologie des Infections Virales et des Maladies auto-Immunes, AP-HP.Université Paris-Saclay, Hôpital Bicêtre, Rheumatology Department, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Wan Fai', 'Initials': 'WF', 'LastName': 'Ng', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University & NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Rosas', 'Affiliation': 'Department of Rheumatology, Hospital Marina Baixa, Villajoyosa.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sánchez Bursón', 'Affiliation': 'Department of Rheumatology, Infanta Luisa Hospital, Sevilla, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Triolo', 'Affiliation': 'Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, Rheumatology Section, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Barone', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Bowman', 'Affiliation': 'National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa410']
3150,32949144,Sialendoscopy increases saliva secretion and reduces xerostomia up to 60 weeks in Sjögren's syndrome patients: a randomized controlled study.,"OBJECTIVE


To assess the effect of sialendoscopy of the major salivary glands on salivary flow and xerostomia in patients with Sjögren's syndrome (SS).
METHODS


Forty-five patients with SS were randomly assigned to a control group (no irrigation, control, n = 15), to irrigation of the major salivary glands with saline (saline, n = 15) or to irrigation with saline followed by corticosteroid application (triamcinolone acetonide in saline, saline/TA, n = 15). Unstimulated whole saliva flow (UWSF), chewing-stimulated whole saliva flow (SWSF), citric acid-stimulated parotid flow, Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI) and EULAR SS Patient Reported Index (ESSPRI) scores were obtained 1 week before (T0), and 1, 8, 16, 24, 36, 48 and 60 weeks after sialendoscopy. Data were analysed using linear mixed models.
RESULTS


Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks. Significant between-group differences in the longitudinal course of outcomes were found for UWSF, SWSF, XI and ESSPRI scores (P = 0.028, P = 0.001, P = 0.03, P = 0.021, respectively). UWSF at 60 weeks was higher compared with T0 in the saline group (median: 0.14 vs median: 0.10, P = 0.02) and in the saline/TA group (median: 0.20, vs 0.13, P = 0.035). In the saline/TA group SWSF at 48 weeks was higher compared with T0 (median: 0.74 vs 0.38, P = 0.004). Increase in unstimulated salivary flow was also reflected in improved CODS, XI and ESSPRI scores compared with baseline.
CONCLUSION


Irrigation of the major salivary glands in patients with SS increases salivary flow and reduces xerostomia.",2020,"Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks.","['Forty-five patients with SS', ""Sjögren's syndrome patients"", ""patients with Sjögren's syndrome (SS""]","['Sialendoscopy', 'control group (no irrigation, control, n\u2009=\u200915), to irrigation of the major salivary glands with saline (saline, n\u2009=\u200915) or to irrigation with saline followed by corticosteroid application (triamcinolone acetonide in saline, saline/TA, n\u2009=\u200915', 'sialendoscopy']","['salivary flow', 'Unstimulated whole saliva flow (UWSF), chewing-stimulated whole saliva flow (SWSF), citric acid-stimulated parotid flow, Clinical Oral Dryness Score (CODS), Xerostomia Inventory (XI) and EULAR SS Patient', 'UWSF', 'CODS, XI and ESSPRI scores', 'saliva secretion and reduces xerostomia', 'salivary flow and reduces xerostomia', 'Index (ESSPRI', 'salivary flow and xerostomia', 'UWSF, SWSF, XI and ESSPRI scores', 'unstimulated salivary flow']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0930553', 'cui_str': 'Major salivary gland structure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",45.0,0.124481,"Irrespective of the irrigation protocol used, sialendoscopy resulted in an increased salivary flow during follow-up up to 60 weeks.","[{'ForeName': 'K Hakki', 'Initials': 'KH', 'LastName': 'Karagozoglu', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Forouzanfar', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam.'}, {'ForeName': 'Jan G A M', 'Initials': 'JGAM', 'LastName': 'de Visscher', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam.'}, {'ForeName': 'Floor', 'Initials': 'F', 'LastName': 'Maarse', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam.'}, {'ForeName': 'Henk S', 'Initials': 'HS', 'LastName': 'Brand', 'Affiliation': 'Department of Oral Biochemistry, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc), Amsterdam, The Netherlands.'}, {'ForeName': 'Derk H Jan', 'Initials': 'DHJ', 'LastName': 'Jager', 'Affiliation': 'Department of Maxillofacial Surgery and Oral Pathology, Amsterdam University Medical Centers (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa284']
3151,32949145,D-CARE - The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost-effectiveness of Health System-based versus Community-based Dementia Care versus Usual Dementia Care.,"BACKGROUND/OBJECTIVES


Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost-effectiveness of community-based versus health system-based dementia care and the effectiveness of both approaches compared to usual care are unknown.
DESIGN


Pragmatic randomized 3-arm superiority trial. The unit of randomization is the PWD/caregiver dyad.
SETTING


4 clinical trial sites (CTS) based in academic and clinical health systems.
PARTICIPANTS


2,150 English- or Spanish-speaking PWD, who are not receiving hospice or residing in a nursing home, and their caregivers.
INTERVENTIONS


Eighteen months of 1) Health systems-based dementia care provided by a nurse practitioner or physician's assistant Dementia Care Specialist who works within the health system, or 2) Community-based dementia care provided by a social worker or nurse Care Consultant who works at a community-based organization, or 3) Usual care with as-needed referral to the Alzheimer's Association Helpline.
MEASUREMENTS


Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales.
SECONDARY OUTCOMES


NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, ""time spent at home"", Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost-effectiveness using intervention costs and Medicare claims.
RESULTS


Will be reported in Spring 2024.
CONCLUSION


D-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared to usual care and will evaluate the cost effectiveness of each intervention.",2020,"NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms.","['4 clinical trial sites (CTS) based in academic and clinical health systems', 'persons living with dementia (PWD) and their family or friend caregivers', ""Eighteen months of 1) Health systems-based dementia care provided by a nurse practitioner or physician's assistant Dementia Care Specialist who works within the health system, or 2"", '2,150 English- or Spanish-speaking PWD, who are not receiving hospice or residing in a nursing home, and their caregivers']","[""Community-based dementia care provided by a social worker or nurse Care Consultant who works at a community-based organization, or 3) Usual care with as-needed referral to the Alzheimer's Association Helpline"", 'Health System-based versus Community-based Dementia Care versus Usual Dementia Care']","['NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms', 'PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales', 'Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, ""time spent at home"", Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost-effectiveness using intervention costs and Medicare claims']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}]",,0.0582374,"NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms.","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Reuben', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': 'Baylor Scott & White Health, Temple, Texas.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Volpi', 'Affiliation': 'University of Texas, Medical Branch, Galveston, Texas.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Lichtenstein', 'Affiliation': 'Geisinger Health, Wilkes Barre, Pennsylvania.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Jennings', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Zaldy', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Evertson', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bass', 'Affiliation': 'Benjamin Rose Institute, Cleveland, Ohio.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Weitzman', 'Affiliation': 'Benjamin Rose Institute, Cleveland, Ohio.'}, {'ForeName': 'Martie', 'Initials': 'M', 'LastName': 'Carnie', 'Affiliation': ""Brigham and Women's Hospital, Center for Patients and Families, Boston, Massachusetts.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Araujo', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Charpentier', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Meng', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Pardee RAND Graduate School, Santa Monica, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Unger', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Currie', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Lenoir', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': ""Aval-Na'Ree S"", 'Initials': 'AS', 'LastName': 'Green', 'Affiliation': 'Baylor Scott & White Health, Temple, Texas.'}, {'ForeName': 'Sitara', 'Initials': 'S', 'LastName': 'Abraham', 'Affiliation': 'Baylor Scott & White Health, Temple, Texas.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vernon', 'Affiliation': 'Baylor Scott & White Health, Temple, Texas.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Samper-Ternent', 'Affiliation': 'University of Texas, Medical Branch, Galveston, Texas.'}, {'ForeName': 'Mukaila', 'Initials': 'M', 'LastName': 'Raji', 'Affiliation': 'University of Texas, Medical Branch, Galveston, Texas.'}, {'ForeName': 'Roxana M', 'Initials': 'RM', 'LastName': 'Hirst', 'Affiliation': 'University of Texas, Medical Branch, Galveston, Texas.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Galloway', 'Affiliation': 'University of Texas, Medical Branch, Galveston, Texas.'}, {'ForeName': 'Glen R', 'Initials': 'GR', 'LastName': 'Finney', 'Affiliation': 'Geisinger Health, Wilkes Barre, Pennsylvania.'}, {'ForeName': 'Ilene', 'Initials': 'I', 'LastName': 'Ladd', 'Affiliation': 'Geisinger Health, Wilkes Barre, Pennsylvania.'}, {'ForeName': 'Alanna Kulchak', 'Initials': 'AK', 'LastName': 'Rahm', 'Affiliation': 'Geisinger Health, Wilkes Barre, Pennsylvania.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Borek', 'Affiliation': 'Geisinger Health, Wilkes Barre, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Peduzzi', 'Affiliation': 'Yale University, New Haven, Connecticut.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16862']
3152,32949226,Non-invasive telemonitoring improves outcomes in heart failure with reduced ejection fraction: a study in high-risk patients.,"AIMS


Non-invasive telemonitoring (TM) in patients with heart failure (HF) and reduced left ventricular ejection fraction (HFrEF) may be useful in the early diagnosis of HF decompensation, allowing therapeutic optimization and avoiding re-hospitalization. We describe a TM programme in this population and evaluate its effectiveness during a 12 month period.
METHODS AND RESULTS


We conducted a single-centre study of patients discharged from hospital after decompensated HF, allocated into three groups: prospective TM programme, prospective HF protocol follow-up programme (PFP) with no TM facilities, and retrospective propensity-matched usual care (UC). TM effectiveness was assessed by all-cause hospitalizations and mortality; HF-related hospitalization (HFH), days lost to unplanned hospital admissions/death, functional capacity and quality of life (New York Heart Association, Kansas City Cardiomyopathy Questionnaire, 6 min walk test, and plasma N-terminal pro-brain natriuretic peptide) were also evaluated. A total of 125 patients were included [65.9 ± 11.9 years, 32% female, left ventricular ejection fraction 27% (21-32)]. TM was similar to PFP regarding effectiveness; TM reduced all-cause hospitalization and mortality (HR 0.27; 95% CI 0.11-0.71; P < 0.01) and HFH (HR 0.29; 95% CI 0.10-0.89; P < 0.05) as compared with UC. TM reduced the average number of days lost due to unplanned hospital admissions or all-cause death as compared with PFP (5.6 vs. 12.4 days, P < 0.05) and UC (5.6 vs. 48.8 days, P < 0.01). Impact on quality of life was similar between TM and PFP (P = 0.36).
CONCLUSIONS


In patients with HFrEF and recent HF hospitalization, non-invasive TM reduced 12 month all-cause hospitalization/mortality and HFH as compared with usual care. TM also reduced the number of days lost due to unplanned hospital admission/death as compared with either an optimized protocol-based follow-up programme or usual care.",2020,"TM reduced the average number of days lost due to unplanned hospital admissions or all-cause death as compared with PFP (5.6 vs. 12.4 days, P < 0.05) and UC (5.6 vs. 48.8 days, P ","['patients with heart failure (HF) and reduced left ventricular ejection fraction (HFrEF', 'patients discharged from hospital after decompensated HF', 'high-risk patients', 'A total of 125 patients were included [65.9\xa0±\xa011.9\xa0years, 32% female, left ventricular ejection fraction 27% (21-32', 'heart failure with reduced ejection fraction']","['invasive telemonitoring (TM', 'TM programme', 'TM', 'HF protocol follow-up programme (PFP) with no TM facilities, and retrospective propensity-matched usual care (UC']","['average number of days lost due to unplanned hospital admissions', 'HFH', 'UC', 'cause hospitalizations and mortality; HF-related hospitalization (HFH), days lost to unplanned hospital admissions/death, functional capacity and quality of life (New York Heart Association, Kansas City Cardiomyopathy Questionnaire, 6\xa0min walk test, and plasma N-terminal pro-brain natriuretic peptide', 'number of days lost due to unplanned hospital admission/death', 'quality of life', 'TM effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",125.0,0.0640217,"TM reduced the average number of days lost due to unplanned hospital admissions or all-cause death as compared with PFP (5.6 vs. 12.4 days, P < 0.05) and UC (5.6 vs. 48.8 days, P ","[{'ForeName': 'Afonso', 'Initials': 'A', 'LastName': 'Nunes-Ferreira', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Agostinho', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Rigueira', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Aguiar-Ricardo', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Guimarães', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Santos', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Rodrigues', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Cunha', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Pedro Silvério', 'Initials': 'PS', 'LastName': 'António', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Sara Couto', 'Initials': 'SC', 'LastName': 'Pereira', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Morais', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Mónica Mendes', 'Initials': 'MM', 'LastName': 'Pedro', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Veiga', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Fausto J', 'Initials': 'FJ', 'LastName': 'Pinto', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}, {'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Brito', 'Affiliation': 'Cardiology Department, Centro Hospitalar Universitário Lisboa Norte, Av. Prof. Egas Moniz, Lisbon, 1649-028, Portugal.'}]",ESC heart failure,['10.1002/ehf2.12999']
3153,32949255,The BUSCOPAN study: a randomized-controlled non-inferiority trial of a continuous butylscopolamine infusion versus placebo in patients with a renal colic not responding to oral non-steroidal anti-inflammatory drugs.,"PURPOSE


To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic.
METHODS


We conducted a placebo-controlled, multicenter, double-blind randomized clinical trial (RCT) including 128 patients with renal colic (confirmed by ultrasound or CT-scan). Patients were randomized to receive either continuous IV butylscopolamine 100 mg/24 h or placebo (saline). Primary outcome is the amount of opioid escape medication used, measured in doses administered. Secondary outcomes are pain measured on a Numeric Rating Scale (NRS), side effects, and time of drug administration. Non-inferiority was assessed using linear regression with robust standard errors, with non-inferiority limit set at 0.5 units of escape medication.
RESULTS


Median number of doses of escape medication was one in both groups. The number of extra doses in the placebo group compared with the butylscopolamine group was 0.05, with a 95% robust confidence interval (CI) of 0.38-0.47. Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04). No differences in secondary endpoints were seen between the groups.
CONCLUSION


Placebo is non-inferior to continuous IV butylscopolamine for pain relief in patients with renal colic. Based on this study and previous evidence, there is no role for continuous butylscopolamine IV in the treatment of renal colic. Trial NL7819.",2020,Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04).,"['patients with renal colic', '128 patients with renal colic (confirmed by ultrasound or CT-scan', 'patients with a renal colic not responding to oral non-steroidal anti-inflammatory drugs']","['continuous butylscopolamine infusion versus placebo', 'placebo', 'butylscopolamine', 'continuous IV butylscopolamine 100\xa0mg/24\xa0h or placebo (saline', 'Placebo', 'butylscopolamine IV']","['amount of opioid escape medication', 'pain measured on a Numeric Rating Scale (NRS), side effects, and time of drug administration', 'number of extra doses', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2827093', 'cui_str': 'butylscopolamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",128.0,0.691792,Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Weltings', 'Affiliation': 'Haga Teaching Hospital, The Hague, The Netherlands. saskiaweltings@gmail.com.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Buddingh', 'Affiliation': 'Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'van Diepen', 'Affiliation': 'Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'R C M', 'Initials': 'RCM', 'LastName': 'Pelger', 'Affiliation': 'LUMC, Leiden, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'LUMC, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rad', 'Affiliation': 'Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'B M A', 'Initials': 'BMA', 'LastName': 'Schout', 'Affiliation': 'Alrijne Health Group, Leiderdorp, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roshani', 'Affiliation': 'Haga Teaching Hospital, The Hague, The Netherlands.'}]",World journal of urology,['10.1007/s00345-020-03460-0']
3154,32949267,"A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers.","PURPOSE


To compare pharmacokinetics, safety, tolerability, and immunogenicity between SB8, a bevacizumab biosimilar, and the European Union (EU) and United States (US) reference products (bevacizumab-EU, bevacizumab-US).
METHODS


In this randomized, double-blind, parallel-group, and single-dose study, healthy volunteers were randomized to receive a 3 mg/kg dose of SB8, bevacizumab-EU, or bevacizumab-US via intravenous infusion. Primary endpoints were area under the concentration-time curve from time zero to infinity (AUC inf ) and to the last quantifiable concentration (AUC last ), and maximum observed serum concentration (C max ). Bioequivalence was achieved if 90% confidence intervals (CIs) for the ratios of the geometric least squares means (LSMeans) of primary endpoints were within the predefined bioequivalence margins of 80.00-125.00%. Safety and immunogenicity were also investigated.
RESULTS


The 90% CIs for the geometric LSMean ratios of AUC inf , AUC last  and C max  were all within the prespecified bioequivalence margins. Geometric LSMean ratios for SB8/bevacizumab-EU, SB8/bevacizumab-US and bevacizumab-EU/bevacizumab-US were 88.01%, 88.48% and 100.54% for AUC inf , 88.65%, 89.08% and 100.49% for AUC last  and 99.59%, 101.15% and 101.56% for C max , respectively. Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%). Most TEAEs were mild and considered as not related to the study drug. No deaths or treatment discontinuations due to adverse events occurred. Incidence of anti-drug antibodies was also comparable between all groups and no neutralizing antibodies were detected.
CONCLUSION


This study demonstrated pharmacokinetic bioequivalence and similar safety and immunogenicity profiles of SB8 to both reference products, bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. CLINICALTRIALS.
GOV IDENTIFIER


NCT02453672 (submitted date); EudraCT number: 2015-001,026-41.",2020,"Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%).",['healthy volunteers'],"['sb8 (bevacizumab biosimilar) with reference bevacizumab', 'bevacizumab-EU', 'SB8, bevacizumab-EU, or bevacizumab-US via intravenous infusion', 'bevacizumab', 'bevacizumab-EU/bevacizumab', 'bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US', 'European Union (EU) and United States (US) reference products (bevacizumab-EU, bevacizumab-US']","['geometric LSMean ratios of AUC inf , AUC last  and C max', 'neutralizing antibodies', 'Safety and immunogenicity', 'area under the concentration-time curve from time zero to infinity (AUC inf ) and to the last quantifiable concentration (AUC last ), and maximum observed serum concentration (C max ', 'pharmacokinetics, safety, tolerability, and immunogenicity', 'Geometric LSMean ratios', 'Incidence of anti-drug antibodies']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.141577,"Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%).","[{'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Medical Affairs, Samsung Bioepis Co., Ltd, Incheon, Korea. dh01.shin@samsung.com.'}, {'ForeName': 'Yoon Jung', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Dahyoung', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Clinical Bioanalysis, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Minjeong', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Medical Affairs, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Petkova', 'Affiliation': 'Clinical Pharmacology Unit, SGS LSS, Antwerpen, Lange Beeldekensstraat 267, 2060, Antwerpen, Belgium.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04144-7']
3155,32949315,Employing Evidence-Based Practices for Children with Autism in Elementary Schools.,"The purpose of this study was to test the efficacy of a comprehensive program model originally developed by the National Professional Development Center on Autism Spectrum Disorder (NPDC). Sixty elementary schools with 486 participants were randomly assigned to an NPDC and services as usual condition (SAU). Significantly greater changes in program quality occurred in the inclusive NPDC programs as compared with the SAU schools. Teachers in NPDC schools reported using more evidence-based practices (EBPs) and implemented EBPs with significantly greater fidelity than teachers in SAU schools. Autistic students in NPDC schools had significantly higher total attainment of educational goals than students in SAU schools, and the two groups made equivalent progress on standardized assessment outcomes across the school year.",2020,Teachers in NPDC schools reported using more evidence-based practices (EBPs) and implemented EBPs with significantly greater fidelity than teachers in SAU schools.,"['Autism Spectrum Disorder (NPDC', 'Children with Autism in Elementary Schools', 'Autistic students in NPDC schools', 'Sixty elementary schools with 486 participants']","['comprehensive program model', 'NPDC and services as usual condition (SAU']","['total attainment of educational goals', 'program quality']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",486.0,0.0292121,Teachers in NPDC schools reported using more evidence-based practices (EBPs) and implemented EBPs with significantly greater fidelity than teachers in SAU schools.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Sam', 'Affiliation': 'Frank Porter Graham Child Development Institute, University of North Carolina at Chapel Hill, 517 S. Greensboro Street, CB 8040, Carrboro, NC, 27510, USA.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Odom', 'Affiliation': 'Frank Porter Graham Child Development Institute, University of North Carolina at Chapel Hill, 517 S. Greensboro Street, CB 8040, Carrboro, NC, 27510, USA. slodom@unc.edu.'}, {'ForeName': 'Brianne', 'Initials': 'B', 'LastName': 'Tomaszewski', 'Affiliation': 'Frank Porter Graham Child Development Institute, University of North Carolina at Chapel Hill, 517 S. Greensboro Street, CB 8040, Carrboro, NC, 27510, USA.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Perkins', 'Affiliation': 'Frank Porter Graham Child Development Institute, University of North Carolina at Chapel Hill, 517 S. Greensboro Street, CB 8040, Carrboro, NC, 27510, USA.'}, {'ForeName': 'Ann W', 'Initials': 'AW', 'LastName': 'Cox', 'Affiliation': 'Frank Porter Graham Child Development Institute, University of North Carolina at Chapel Hill, 517 S. Greensboro Street, CB 8040, Carrboro, NC, 27510, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04706-x']
3156,32878814,Cabazitaxel - A Treatment Option in Recurrent Platinum-resistant Ovarian Cancer.,"BACKGROUND/AIM


Treatment of recurrent platinum-resistant ovarian cancer remains challenging due to the development of resistance to chemotherapy. Cabazitaxel is a new taxane that has demonstrated beneficial effect in prostate cancer patients resistant to docetaxel. Therefore, it could be anticipated to possibly also have an effect on chemotherapy resistant ovarian cancer.
PATIENTS AND METHODS


Twenty-six patients with chemotherapy-resistant epithelial ovarian cancer, fallopian tube or peritoneal cancer were treated with cabazitaxel at a dose of 25 mg/m 2  (on day 1 of each 3-week cycle), until progression or inacceptable toxicity, between September 2015 and April 2018. The fraction of patients without progression after three months of treatment was the primary endpoint. Prophylaxis with granulocyte colony-stimulating factor (G-CSF) was prescribed to all patients.
RESULTS


The median number of cabazitaxel infusions was 4 (range=1-18). In general, cabazitaxel was well-tolerated. The fraction of patients alive and without progression after 3 months of treatment was 54% (14/26). The response rate was 46% (12/26) according to the Gynecological Cancer Intergroup (GCIG) criteria for CA125. Partial response (PR), evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST), was found in 4/26 patients (15%). By intention-to-treat analysis, the median progression-free survival (PFS) was 3.9 months (95% CI=1.9-4.4) using the combination of CA125 or RECIST (whichever came first), while the median overall survival (OS) was 8.4 months (95% CI=5.1-11.0).
CONCLUSION


Cabazitaxel holds promise as a drug in recurrent platinum-resistant ovarian cancer. It demonstrated efficacy and in general, the toxicity was manageable.",2020,The response rate was 46% (12/26) according to the Gynecological Cancer Intergroup (GCIG) criteria for CA125.,"['prostate cancer patients resistant to docetaxel', 'Twenty-six patients with chemotherapy-resistant epithelial ovarian cancer, fallopian tube or peritoneal cancer', 'Recurrent Platinum-resistant Ovarian Cancer', 'recurrent platinum-resistant ovarian cancer']","['cabazitaxel', 'granulocyte colony-stimulating factor (G-CSF']","['median number of cabazitaxel infusions', 'median progression-free survival (PFS', 'Partial response (PR', 'fraction of patients alive and without progression', 'response rate', 'median overall survival (OS']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0015560', 'cui_str': 'Fallopian tube structure'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",26.0,0.0875634,The response rate was 46% (12/26) according to the Gynecological Cancer Intergroup (GCIG) criteria for CA125.,"[{'ForeName': 'Christine Vestergaard', 'Initials': 'CV', 'LastName': 'Madsen', 'Affiliation': 'Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Vejle, Denmark Christine.Vestergaard.Madsen@rsyd.dk.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Adimi', 'Affiliation': 'Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Vejle, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Vejle, Denmark.'}, {'ForeName': 'Karina Dahl', 'Initials': 'KD', 'LastName': 'Steffensen', 'Affiliation': 'Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Vejle, Denmark.'}]",Anticancer research,['10.21873/anticanres.14529']
3157,32899067,Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).,"BACKGROUND


Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut.
METHODS


Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis.
DISCUSSION


We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.",2020,The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs.,"['atrial fibrillation', 'patients with nonvalvular atrial fibrillation']","['direct-acting oral anticoagulants vs vitamin K antagonists', 'direct oral anticoagulants versus vitamin K antagonist']","['ischaemic stroke', 'Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3653500', 'cui_str': 'Direct factor Xa inhibitors'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.0427159,The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs.,"[{'ForeName': 'Zojaina', 'Initials': 'Z', 'LastName': 'Hernández Rojas', 'Affiliation': ""Equip d'Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa, Tarragona, Spain.""}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Dalmau Llorca', 'Affiliation': ""Equip d'Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa, Tarragona, Spain.""}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Aguilar Martín', 'Affiliation': ""Unitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Tortosa, Tarragona, Spain.""}, {'ForeName': 'Alessandra Queiroga', 'Initials': 'AQ', 'LastName': 'Gonçalves', 'Affiliation': ""Unitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Tortosa, Tarragona, Spain.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Casajuana', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernández-Sáez', 'Affiliation': ""Unitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Tortosa, Tarragona, Spain.""}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Rodríguez Cumplido', 'Affiliation': 'GAVINA Research Grup.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Forcadell Drago', 'Affiliation': 'GAVINA Research Grup.'}, {'ForeName': 'Noèlia', 'Initials': 'N', 'LastName': 'Carrasco-Querol', 'Affiliation': ""Unitat de Suport a la Recerca Terres de l'Ebre, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Tortosa, Tarragona, Spain.""}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Pepió Vilaubí', 'Affiliation': 'GAVINA Research Grup.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Alegret', 'Affiliation': 'Grup de Recerca Cardiovascular, Departament de Cardiologia, Hospital Universitari de Sant Joan, Institut de Investigació Sanitaria Pere Virgili (IISPV), Reus, Spain.'}]",Medicine,['10.1097/MD.0000000000022054']
3158,32948200,Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis.,"BACKGROUND


Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 10 6  bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial.
METHODS


A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diagnosed with knee OA were randomly assigned to 3 weekly doses of PRGF® or intraarticular administration of 100 × 10 6  cultured autologous BM-MSCs plus PRGF®. Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage.
RESULTS


No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF® and BM-MSC with PRGF® went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF® was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF® was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF® could be considered as a OA treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage.
CONCLUSIONS


Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-23.",2020,No adverse effects were reported after BM-MSC administration or during follow-up.,"['Sixty patients diagnosed with knee OA', 'knee osteoarthritis']","['PRGF® or intraarticular administration of 100\u2009×\u200910 6  cultured autologous BM-MSCs plus PRGF®', 'intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma', '100\u2009×\u200910 6  bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®', 'X-ray and MRI (WORMS protocol']","['mean (SD) baseline and 12-month overall WOMAC scores', 'pain and function', 'adverse effects', 'knee joint space width or joint damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C4704952', 'cui_str': 'Bone Marrow Mesenchymal Stem Cells'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",60.0,0.0966388,No adverse effects were reported after BM-MSC administration or during follow-up.,"[{'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Lamo-Espinosa', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. jlamodeespi@unav.es.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Blanco', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Sánchez', 'Affiliation': 'Arthroscopic Surgery Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Froilán', 'Initials': 'F', 'LastName': 'Granero-Moltó', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Sánchez-Guijo', 'Affiliation': 'Department of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Íñigo', 'Initials': 'Í', 'LastName': 'Crespo-Cullel', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Mora', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Diego Delgado', 'Initials': 'DD', 'LastName': 'San Vicente', 'Affiliation': 'Advanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Pompei-Fernández', 'Affiliation': 'Advanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jesús Dámaso', 'Initials': 'JD', 'LastName': 'Aquerreta', 'Affiliation': 'Department of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Jorge María', 'Initials': 'JM', 'LastName': 'Núñez-Córdoba', 'Affiliation': 'Division of Biostatistics, Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Vitoria Sola', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Valentí-Azcárate', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Enrique J', 'Initials': 'EJ', 'LastName': 'Andreu', 'Affiliation': 'Cell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Consuelo Del Cañizo', 'Affiliation': 'Department of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Juan Ramón', 'Initials': 'JR', 'LastName': 'Valentí-Nin', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Prósper', 'Affiliation': 'Cell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. fprosper@unav.es.'}]",Journal of translational medicine,['10.1186/s12967-020-02530-6']
3159,32948224,"Egg white hydrolyzate reduces mental fatigue: randomized, double-blind, controlled study.","OBJECTIVES


This study aimed to show that ingesting egg white hydrolyzate (EWH) could improve antioxidant capacity and reduce mental fatigue. Two clinical trials were conducted to examine the antioxidant capacity and the fatigue reduction function of EWH. In Study 1, 19 athlete students were received a single dose of EWH (5 g/day) or placebo. In Study 2, 74 athlete students ingested EWH (5 g/day) or placebo before training for 2 weeks.
RESULTS


Single dose of EWH significantly increased the antioxidant ability compared with the placebo group (p < 0.05), and there was no significant difference between the groups in the oxidative stress test results on Study 1. Two-week intake of EWH significantly decreased mental fatigue compared with the placebo (p < 0.05). This study showed that ingesting EWH improved antioxidant capacity with a single dose and reduced mental fatigue after 2 weeks of ingestion. Trial Registration Japan Medical Association Center for Clinical Trials identifier; JMA-IIA00395 (Study1) and JMA-IIA00396 (Study2), both trials were retrospectively registered on 26 October, 2018.",2020,"Single dose of EWH significantly increased the antioxidant ability compared with the placebo group (p < 0.05), and there was no significant difference between the groups in the oxidative stress test results on Study 1.","['74 athlete students ingested EWH (5\xa0g/day) or', 'Egg white hydrolyzate reduces mental fatigue', '19 athlete students']","['ingesting egg white hydrolyzate (EWH', 'placebo', 'EWH']","['antioxidant capacity', 'mental fatigue', 'antioxidant capacity and reduce mental fatigue', 'antioxidant ability']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.47525,"Single dose of EWH significantly increased the antioxidant ability compared with the placebo group (p < 0.05), and there was no significant difference between the groups in the oxidative stress test results on Study 1.","[{'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Oe', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Hisae', 'Initials': 'H', 'LastName': 'Sakamoto', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Ryou', 'Initials': 'R', 'LastName': 'Sasahara', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Masuda', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan. yasunobu_masuda@kewpie.co.jp.'}, {'ForeName': 'Mizuho', 'Initials': 'M', 'LastName': 'Adachi', 'Affiliation': 'Nippon Sport Science University, 7-1-1 Fukazawa, Setagaya-ku, Tokyo, 158-8508, Japan.'}, {'ForeName': 'Tetsunari', 'Initials': 'T', 'LastName': 'Nishiyama', 'Affiliation': 'Nippon Sport Science University, 7-1-1 Fukazawa, Setagaya-ku, Tokyo, 158-8508, Japan.'}]",BMC research notes,['10.1186/s13104-020-05288-8']
3160,32948270,Letter to the editor: Inspiratory muscle training did not improve exercise capacity and lung function in adult patients with Fontan circulation: A randomized controlled trial.,,2020,,['adult patients with Fontan circulation'],['editor: Inspiratory muscle training'],['exercise capacity and lung function'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5197853', 'cui_str': 'Fontan Circuit'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0485841,,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Department of Rehabilitation, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan; Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. Electronic address: sasaki.kosuke.u73@kyoto-u.jp.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.069']
3161,32029134,Haptoglobin Phenotype Modifies the Influence of Intensive Glycemic Control on Cardiovascular Outcomes.,"BACKGROUND


Whereas there exists a direct relationship between glycated hemoglobin and cardiovascular disease (CVD), clinical trials targeting glycated hemoglobin to near-normal levels using intensive therapy have failed to prevent CVD and have even increased mortality, making clinical decision making difficult. A common polymorphism at the haptoglobin (Hp) genetic locus is associated with CVD, especially coronary heart disease, in the setting of hyperglycemia.
OBJECTIVES


This study sought to determine whether the treatment difference of intensive versus standard glucose-lowering therapy on risk of CVD events in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study depended on Hp phenotype.
METHODS


Hp phenotype was measured within 5,806 non-Hispanic white ACCORD participants using a validated assay. Adjusted hazard ratios (aHR) with 95% confidence intervals (CI) estimated from stratified Cox regression models were used to quantify the association between intensive therapy and incident CVD for the 2 different Hp phenotype groups (Hp2-2, Hp1 carriers).
RESULTS


Compared with standard therapy, intensive therapy was associated with a lower risk of incident coronary heart disease among participants with the Hp2-2 phenotype (n = 2,133; aHR: 0.71; 95% CI: 0.55 to 0.91; p = 0.006), but not among the other 2 phenotypes (Hp1 allele carriers) (n = 3,673; aHR: 0.95; 95% CI: 0.79 to 1.13; p = 0.550). The same pattern was observed for CVD. Conversely, intensive therapy was associated with an increased risk of fatal CVD (aHR: 1.50; 95% CI: 1.00 to 2.25; p = 0.049) and total mortality (aHR: 1.40; 95% CI: 1.08 to 1.81; p = 0.011) among the Hp1 carriers, whereas this risk was not increased in the Hp2-2 phenotype (fatal CVD: aHR: 1.02; 95% CI: 0.59 to 1.77; p = 0.931; total mortality: aHR: 0.98; 95% CI: 0.68 to 1.41; p = 0.908).
CONCLUSIONS


Intensive glucose-lowering therapy was effective at preventing incident coronary heart disease and CVD events in ACCORD study participants with the Hp2-2 phenotype but not in Hp1 carriers, who had increased mortality risk from intensive therapy.",2020,"Compared with standard therapy, intensive therapy was associated with a lower risk of incident coronary heart disease among participants with the Hp2-2 phenotype (n = 2,133; aHR: 0.71; 95% CI: 0.55 to 0.91; p = 0.006), but not among the other 2 phenotypes (Hp1 allele carriers) (n = 3,673; aHR: 0.95; 95% CI: 0.79 to 1.13; p = 0.550).",[],"['Intensive glucose-lowering therapy', 'intensive versus standard glucose-lowering therapy']","['lower risk of incident coronary heart disease', 'mortality risk', 'incident coronary heart disease and CVD events', 'Cardiovascular Outcomes', 'total mortality', 'risk of fatal CVD', 'risk of CVD events', 'Adjusted hazard ratios (aHR']",[],"[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",5806.0,0.177823,"Compared with standard therapy, intensive therapy was associated with a lower risk of incident coronary heart disease among participants with the Hp2-2 phenotype (n = 2,133; aHR: 0.71; 95% CI: 0.55 to 0.91; p = 0.006), but not among the other 2 phenotypes (Hp1 allele carriers) (n = 3,673; aHR: 0.95; 95% CI: 0.79 to 1.13; p = 0.550).","[{'ForeName': 'Allie S', 'Initials': 'AS', 'LastName': 'Carew', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Levy', 'Affiliation': 'Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Coca', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Lache', 'Affiliation': 'Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ransom', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Byington', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gardner', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Leah E', 'Initials': 'LE', 'LastName': 'Cahill', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. Electronic address: leah.cahill@dal.ca.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.11.051']
3162,32949568,AMBULATORY REFLUX MONITORING GUIDES PROTON PUMP INHIBITOR DISCONTINUATION IN PATIENTS WITH GASTROESOPHAGEAL REFLUX SYMPTOMS: A CLINICAL TRIAL.,"BACKGROUND & AIMS


Proton pump inhibitor (PPI) therapy fails to provide adequate symptom control in up to 50% of patients with gastroesophageal reflux symptoms. While a proportion do not require ongoing PPI therapy, a diagnostic approach to identify candidates appropriate for PPI cessation is not available. This study aimed to examine the clinical utility of prolonged wireless reflux monitoring to predict ability to discontinue PPI.
METHODS


This double-blinded clinical trial performed over three years at two centers enrolled adults with troublesome esophageal symptoms of heartburn, regurgitation, and/or chest pain and inadequate PPI response. Participants underwent prolonged wireless reflux monitoring (off PPI for >7 days) and a three-week PPI cessation intervention. Primary outcome was tolerance of PPI cessation (discontinued or resumed PPI). Symptom burden was quantified using the Reflux Symptom Questionnaire electronic Diary (RESQ-eD).
RESULTS


Of 128 enrolled, 100 participants met inclusion criteria (mean age 48.6 years; 41 male). Thirty-four (34%) participants discontinued PPI. The strongest predictor of PPI discontinuation was number of days with acid exposure time (AET)>4.0% (OR 1.82;p<0.001). Participants with 0 days of AET>4.0% had a 10 times increased odds of discontinuing PPI than participants with 4 days of AET>4.0%. Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD: -43.7% vs -5.3%;p=0.04).
CONCLUSION


Among patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis, acid exposure on reflux monitoring predicted ability to discontinue PPI without symptom escalation. Upfront reflux monitoring off acid suppression can limit unnecessary PPI use and guide personalized management.",2020,"Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD: -43.7% vs -5.3%;p=0.04).
","['100 participants met inclusion criteria (mean age 48.6 years; 41 male', 'Of 128 enrolled', 'patients with gastroesophageal reflux symptoms', 'three years at two centers enrolled adults with troublesome esophageal symptoms of heartburn, regurgitation, and/or chest pain and inadequate PPI response', 'patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis']","['Proton pump inhibitor (PPI) therapy', 'prolonged wireless reflux monitoring', 'PUMP']","['tolerance of PPI cessation (discontinued or resumed PPI', 'Reflux Symptom Questionnaire electronic Diary (RESQ-eD', 'odds of discontinuing PPI', 'Reduction in symptom burden']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",128.0,0.0894531,"Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD: -43.7% vs -5.3%;p=0.04).
","[{'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Yadlapati', 'Affiliation': 'Division of Gastroenterology, University of California, San Diego School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Masihi', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'C Prakash', 'Initials': 'CP', 'LastName': 'Gyawali', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Dustin A', 'Initials': 'DA', 'LastName': 'Carlson', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kahrilas', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Billy Darren', 'Initials': 'BD', 'LastName': 'Nix', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Triggs', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Vaezi', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Kia', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kaizer', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Colorado School of Public Health, Department of Biostatistics and Informatics, Aurora, CO, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pandolfino', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: j-pandolfino@northwestern.edu.'}]",Gastroenterology,['10.1053/j.gastro.2020.09.013']
3163,32949650,"Multimorbidity, glycaemic variability and time in target range in people with type 2 diabetes: a baseline analysis of the GP-OSMOTIC trial.","AIMS


To explore associations between multimorbidity condition counts (total; concordant (diabetes-related); discordant (unrelated to diabetes)) and glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR)) using data from a randomised controlled trial examining effectiveness of continuous glucose monitoring (CGM) in people with type 2 diabetes (T2D).
METHODS


Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) trial from 25 general practices in Australia. Number of long-term conditions (LTCs) in addition to T2D used to quantify total/concordant/discordant multimorbidity counts. GV (measured by coefficient of variation (CV)) and TIR derived from CGM data. Multivariable linear regression models used to examine associations between multimorbidity counts, HbA1c (%), GV and TIR.
RESULTS


Mean (SD) age of participants 60.4 (9.9) years; 40.9% female. Multimorbidity was present in 89.2% of participants. Most prevalent comorbid LTCs: hypertension (57.4%), painful conditions (29.8%), coronary heart disease (22.6%) and depression (19.0%). No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
CONCLUSIONS


While multimorbidity was common in this T2D cohort, it was not associated with HbA1c, CV or TIR. Future studies should explore factors other than glycaemia that contribute to the increased mortality observed in those with multimorbidity and T2D.",2020,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","['people with type 2 diabetes', 'Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring', 'Mean (SD) age of participants 60.4 (9.9) years; 40.9% female', '25 general practices in Australia', 'people with type 2 diabetes (T2D']",['continuous glucose monitoring (CGM'],"['Number of long-term conditions (LTCs', 'GV (measured by coefficient of variation (CV)) and TIR', 'coronary heart disease', 'multimorbidity counts, HbA1c, GV and TIR', 'glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR', 'Multimorbidity', 'HbA1c, CV or TIR', 'Multimorbidity, glycaemic variability and time in target range', 'multimorbidity counts, HbA1c (%), GV and TIR', 'painful conditions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",279.0,0.207765,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'I Chiang', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia. Electronic address: jason.chiang@unimelb.edu.au.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Manski-Nankervis', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Sharmala', 'Initials': 'S', 'LastName': 'Thuraisingam', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Neal"", 'Affiliation': ""Department of Medicine, St Vincent's Hospital, University of Melbourne, Australia.""}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Bhautesh', 'Initials': 'B', 'LastName': 'Dinesh Jani', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'I Nicholl', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108451']
3164,32949673,Effects of appetitive and aversive motivational states on wanting and liking of interpersonal touch.,"Social rewards represent a strong driving force behind decisions and behaviors. Previous research suggests that the processing of a reward depends on the initial state of the individual. However, empirical research in humans on the influence of motivational states on reward processing is scant, especially for rewards of social nature. In the present study, we aimed at investigating how aversive and appetitive motivation affects the processing of social rewards, such as interpersonal touch. Participants (n = 102) were assigned to an appetitive (positive) or aversive (negative) motivational state condition (via modified versions of the Trier Social Stress Test) or to a control condition. After the state induction, their a) self-reports of wanting and liking, b) effort, and c) hedonic facial reactions during anticipation and consumption of interpersonal touch, were measured. Participants in the aversive group showed higher subjective wanting of interpersonal touch, but no changes in subjective liking, compared to the control group. The aversive group also showed stronger positive hedonic facial reactions during reward anticipation, reflecting stronger anticipatory pleasure. No significant effects were found for the appetitive group. The results indicate that, after having been exposed to an aversive experience, the motivation to obtain interpersonal touch, as well as the associated anticipatory pleasure, increase, without a corresponding change in liking during or after its consumption. The findings point to differential state-dependent effects on the processing of social rewards, possibly due to the action of different neurobiological systems regulating reward anticipation and consumption.",2020,"Participants in the aversive group showed higher subjective wanting of interpersonal touch, but no changes in subjective liking, compared to the control group.",['Participants (n = 102'],"['appetitive and aversive motivational states', 'appetitive (positive) or aversive (negative) motivational state condition (via modified versions of the Trier Social Stress Test) or to a control condition']","['subjective liking', 'positive hedonic facial reactions', 'wanting and liking of interpersonal touch', 'subjective wanting of interpersonal touch']",[],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]",102.0,0.0154452,"Participants in the aversive group showed higher subjective wanting of interpersonal touch, but no changes in subjective liking, compared to the control group.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Massaccesi', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria. Electronic address: claudia.massaccesi@univie.ac.at.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Korb', 'Affiliation': 'Faculty of Psychology, Department of Cognition, Emotion, and Methods in Psychology, University of Vienna, Austria; Faculty of Psychology, University of Essex, Colchester, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Skoluda', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Silani', 'Affiliation': 'Faculty of Psychology, Department of Clinical and Health Psychology, University of Vienna, Austria. Electronic address: giorgia.silani@univie.ac.at.'}]",Neuroscience,['10.1016/j.neuroscience.2020.09.025']
3165,32949760,A localized laminar flow device decreases airborne particulates during shoulder arthroplasty: A randomized controlled trial.,"BACKGROUND


Although the rate of periprosthetic joint infection following shoulder arthroplasty is low, it is a morbid and costly complication. Airborne particulates have long been recognized as a potential source of wound contamination and operating room mounted, and smaller localized laminar air flow devices have been developed to minimize airborne particulates. This randomized controlled trial evaluated the effectiveness of a localized laminar flow device in reducing the intrusion of ambient airborne particles and bacteria into the surgery site during shoulder arthroplasty as measured by overall particle counts and colony forming units.
METHODS


Patients undergoing primary anatomic or reverse shoulder arthroplasty were eligible for participation. After informed consent, patients were randomly assigned to the air barrier system (ABS) or control group. For all patients, the ABS was placed on the surgical field but was only turned on by the technician for subjects randomized to ABS. Study participants, surgeons and surgical staff were blinded to group assignment. Bacterial colony forming units (CFU) were collected from within 5 cm of the surgical wound every 10 minutes, while airborne particulates were collected every minute. Poisson regression models were used to determine if differences existed in CFUs and particulate counts between the ABS and control groups.
RESULTS


Forty-three patients were randomized into the ABS (n=21) and control (n=22) groups. Surgical time (p=.53) and the average staff count (p=.16) in the operating room did not differ between groups. Poisson regression showed that ABS group had significantly lower CFUs (β=-0.583, p<0.001) along with surgical time and particulates with a diameter greater than 5μm. Staff count and particulates smaller than 5μm were not significant predictors of CFUs. Infection was not a primary outcome, but no postoperative infections have been reported in either study group with a minimum of 1-year follow-up for all patients.
DISCUSSION


This double-blinded, randomized trial demonstrated that a localized laminar flow device dramatically reduces the count of CFUs in the air directly above the wound and beneath the air barrier system (adjusted for the number of OR personnel and surgical time). The use of the device was not associated with a longer case duration; however, there was some additional set up time prior to surgical incision to place the device. Further study is required to determine the clinical implications of this finding; specifically, if such devices result in lower rates of periprosthetic joint infection after shoulder arthroplasty.
LEVEL OF EVIDENCE


Level I; Randomized Controlled Trial; Treatment Study.",2020,Surgical time (p=.53) and the average staff count (p=.16) in the operating room did not differ between groups.,"['Study participants, surgeons and surgical staff', 'Forty-three patients were randomized into the ABS (n=21) and control (n=22) groups', 'Patients undergoing primary anatomic or reverse shoulder arthroplasty were eligible for participation', 'shoulder arthroplasty']","['air barrier system (ABS) or control group', 'ABS', 'localized laminar flow device']","['average staff count', 'CFUs', 'CFUs and particulate counts', 'Surgical time', 'count of CFUs', 'Bacterial colony forming units (CFU']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0205274', 'cui_str': 'Laminar'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",43.0,0.146242,Surgical time (p=.53) and the average staff count (p=.16) in the operating room did not differ between groups.,"[{'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Morris', 'Affiliation': 'Fondren Orthopedic Group, Texas Orthopedic Hospital, 7401 South Main Street, Houston, Texas 77030, USA; Fondren Orthopedic Research Institute (FORI), 7401 South Main Street, Houston, Texas 77030, USA; Texas Education and Research Foundation for Shoulder and Elbow Surgery, Inc. (TERFSES), 7401 South Main Street, Houston, Texas 77030, USA.'}, {'ForeName': 'Casey J', 'Initials': 'CJ', 'LastName': 'Kiser', 'Affiliation': 'Geisinger Holy Spirit - Orthopaedics and Sports Medicine, 429 North 21st Street, Camp Hill, PA 17011, USA.'}, {'ForeName': 'Mitzi S', 'Initials': 'MS', 'LastName': 'Laughlin', 'Affiliation': 'Fondren Orthopedic Research Institute (FORI), 7401 South Main Street, Houston, Texas 77030, USA; Texas Education and Research Foundation for Shoulder and Elbow Surgery, Inc. (TERFSES), 7401 South Main Street, Houston, Texas 77030, USA. Electronic address: Mitzi.Laughlin@fondren.com.'}, {'ForeName': 'Mihir M', 'Initials': 'MM', 'LastName': 'Sheth', 'Affiliation': 'Department of Orthopaedic Surgery, Baylor College of Medicine, 7200 Cambridge Street Suite 10A, Houston, TX 77030, USA.'}, {'ForeName': 'Warren R', 'Initials': 'WR', 'LastName': 'Dunn', 'Affiliation': 'Fondren Orthopedic Research Institute (FORI), 7401 South Main Street, Houston, Texas 77030, USA; Texas Education and Research Foundation for Shoulder and Elbow Surgery, Inc. (TERFSES), 7401 South Main Street, Houston, Texas 77030, USA.'}, {'ForeName': 'Hussein A', 'Initials': 'HA', 'LastName': 'Elkousy', 'Affiliation': 'Fondren Orthopedic Group, Texas Orthopedic Hospital, 7401 South Main Street, Houston, Texas 77030, USA; Fondren Orthopedic Research Institute (FORI), 7401 South Main Street, Houston, Texas 77030, USA; Texas Education and Research Foundation for Shoulder and Elbow Surgery, Inc. (TERFSES), 7401 South Main Street, Houston, Texas 77030, USA.'}, {'ForeName': 'T Bradley', 'Initials': 'TB', 'LastName': 'Edwards', 'Affiliation': 'Fondren Orthopedic Group, Texas Orthopedic Hospital, 7401 South Main Street, Houston, Texas 77030, USA; Fondren Orthopedic Research Institute (FORI), 7401 South Main Street, Houston, Texas 77030, USA; Texas Education and Research Foundation for Shoulder and Elbow Surgery, Inc. (TERFSES), 7401 South Main Street, Houston, Texas 77030, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.08.035']
3166,32949780,Induction of LTD-like corticospinal plasticity by low-frequency rTMS depends on pre-stimulus phase of sensorimotor μ-rhythm.,"BACKGROUND


Neural oscillations reflect rapidly changing brain excitability states. We have demonstrated previously with EEG-triggered transcranial magnetic stimulation (TMS) of human motor cortex that the positive vs. negative peak of the sensorimotor μ-oscillation reflect corticospinal low-vs. high-excitability states. In vitro experiments showed that induction of long-term depression (LTD) by low-frequency stimulation depends on the postsynaptic excitability state.
OBJECTIVE/HYPOTHESIS


We tested the hypothesis that induction of LTD-like corticospinal plasticity in humans by 1 Hz repetitive TMS (rTMS) is enhanced when rTMS is synchronized with the low-excitability state, but decreased or even shifted towards long-term (LTP)-like plasticity when synchronized with the high-excitability state.
METHODS


We applied real-time EEG-triggered 1-Hz-rTMS (900 pulses) to the hand area of motor cortex in healthy subjects. In a randomized double-blind three-condition crossover design, pulses were synchronized to either the positive or negative peak of the sensorimotor μ-oscillation, or were applied at random phase (control). The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
RESULTS


1-Hz-rTMS at random phase resulted in a trend towards LTD-like corticospinal plasticity. RTMS in the positive peak condition (i.e., the low-excitability state) induced significant LTD-like plasticity. RTMS in the negative peak condition (i.e., the high-excitability state) showed a trend towards LTP-like plasticity, which was significantly different from the other two conditions.
CONCLUSION


The level of corticospinal depolarization reflected by phase of the μ-oscillation determines the degree of corticospinal plasticity induced by low-frequency rTMS, a finding that may guide future personalized therapeutic stimulation.",2020,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
",['healthy subjects'],"['Hz repetitive TMS (rTMS', '1-Hz-rTMS', 'EEG-triggered transcranial magnetic stimulation (TMS']","['amplitude of motor evoked potentials', 'induction of long-term depression (LTD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.095784,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Galevska', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.09.005']
3167,32948472,Improvements in Antibiotic Appropriateness for Cystitis in Older Nursing Home Residents: A Quality Improvement Study With Randomized Assignment.,"OBJECTIVE


To determine the impact of an educational quality improvement initiative on the appropriateness of antibiotic prescribing restricted to uncomplicated cystitis in older noncatheterized nursing home residents.
DESIGN


Quality improvement study with randomized assignment.
SETTINGS AND PARTICIPANTS


Twenty-five nursing homes in United States were randomized to the intervention or usual care group by strata that included state, urban/rural status, bed size, and geographic separation.
METHODS


A 12-month trial of a low-intensity multifaceted antimicrobial stewardship intervention focused on uncomplicated cystitis in nursing home residents vs usual care. The outcome was the modified Medication Appropriateness Index as assessed by a blinded geriatric clinical pharmacist and consisted of an assessment of antibiotic effectiveness, dosage, drug-drug interactions, and duration.
RESULTS


There were 75 cases (0.15/1000 resident days) in intervention and 92 (0.22/1000 resident days) in control groups with a probable cystitis per consensus guidelines. Compared with controls, there was a statistically nonsignificant 21% reduction in the risk of inappropriate antibiotic prescribing (nonzero Medication Appropriateness Index score rate 0.13 vs 0.21/1000 person days; adjusted incident rate ratio 0.79; 95% confidence interval 0.45‒1.38). There was a favorable comparison in inappropriateness of duration (77% vs 89% for intervention vs control groups, respectively; P = .0394). However, the intervention group had more problems with drug-drug interactions than the control group (8% vs 1%, respectively; P = .0463). Similarly, the intervention group had a nonsignificant trend toward more problems with dosage (primarily because of the lack of adjustment for decreased renal function) than the control group (32% vs 25%, respectively; P = .3170). Both groups had similar rates of problems with choice/effectiveness (44% vs 45%; P = .9417). The most common class of antibiotics prescribed inappropriately was quinolones (25% vs 23% for intervention versus control groups, respectively; P = .7057).
CONCLUSIONS AND IMPLICATIONS


A low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis. Efforts to improve antibiotic prescribing in addition to the low-intensity intervention might include a consultant pharmacist in a nursing home to identify inappropriate prescribing practices.",2020,A low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis.,"['Older Nursing Home Residents', 'nursing home residents vs usual care', 'older noncatheterized nursing home residents', 'Twenty-five nursing homes in United States', 'nursing home residents with likely uncomplicated cystitis']","['intervention or usual care group by strata that included state, urban/rural status, bed size, and geographic separation', 'low-intensity multifaceted antimicrobial stewardship intervention']","['risk of inappropriate antibiotic prescribing (nonzero Medication Appropriateness Index score rate', 'renal function', 'rates of problems with choice/effectiveness', 'antibiotic effectiveness, dosage, drug-drug interactions, and duration', 'modified Medication Appropriateness Index', 'problems with drug-drug interactions', 'appropriate antibiotic prescribing', 'inappropriateness of duration']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600244', 'cui_str': 'Bed Sizes'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0778407,A low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis.,"[{'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hanlon', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, PA; Geriatic Research Education and Clinical Center/Center for Health Equity Research and Promotion, VA Pittsburgh Health System, Pittsburgh, PA. Electronic address: jth14@pitt.edu.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, PA; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Schweon', 'Affiliation': 'Infection Prevention Consultant, Saylorsburg, PA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drinka', 'Affiliation': 'Division of Internal Medicine and Geriatrics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Crnich', 'Affiliation': 'Division of Infectious Diseases, University of Wisconsin School of Medicine and Public Health, Madison, WI; William S. Middleton VA Hospital, Madison, WI.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, PA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.07.040']
3168,32948514,Self-administration of adrenaline for anaphylaxis during in-hospital food challenges improves health-related quality of life.,"OBJECTIVE


To assess the impact of anaphylaxis on health-related quality of life (HRQL) and self-efficacy in food-allergic patients undergoing in-hospital food challenge.
DESIGN


Secondary analysis of a randomised controlled trial.
SETTING


Specialist allergy centre.
PATIENTS


Peanut-allergic young people aged 8-16 years.
INTERVENTIONS


Double-blind, placebo-controlled food challenge to peanut, with HRQL and self-efficacy assessed using validated questionnaire, approximately 2 weeks prior to and 2 weeks after challenge. Where possible, anaphylaxis was treated with self-injected adrenaline (epinephrine).
MAIN OUTCOME MEASURES


Change in HRQL and self-efficacy.
RESULTS


56 participants had reactions at food challenge, of whom 16 (29%) had anaphylaxis. Overall, there was an improvement in HRQL (mean 2.6 points (95% CI 0.3 to 4.8); p=0.030) and self-efficacy (mean 4.1 points (95% CI 2.4 to 5.9); p<0.0001), independent of whether anaphylaxis occurred. Parents also reported improved HRQL (mean 10.3 points (95% CI 5.9 to 14.7); p<0.0001). We found evidence of discordance between the improvement in HRQL and self-efficacy as reported by young people and that perceived by parents in their child.
CONCLUSIONS


Anaphylaxis at food challenge, followed by self-administration of injected adrenaline, was associated with an increase in HRQL and self-efficacy in young people with peanut allergy. We found no evidence that the occurrence of anaphylaxis had a detrimental effect. Young people should be encouraged to self-administer adrenaline using their autoinjector device to treat anaphylaxis at in-hospital challenge.
TRIAL REGISTRATION NUMBER


NCT02149719.",2020,Parents also reported improved HRQL,"['food-allergic patients undergoing in-hospital food challenge', 'young people with peanut allergy', '56 participants had reactions at food challenge, of whom 16 (29%) had anaphylaxis', 'Peanut-allergic young people aged 8-16 years', 'Specialist allergy centre', 'Young people']","['adrenaline (epinephrine', 'placebo-controlled food challenge to peanut, with HRQL', 'adrenaline']","['health-related quality of life', 'HRQL and self-efficacy', 'self-efficacy', 'HRQL', 'health-related quality of life (HRQL) and self-efficacy']","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.386454,Parents also reported improved HRQL,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Burrell', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Nandinee', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Vazquez-Ortiz', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': 'Discipline of Child and Adolescent Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'School of Applied Psychology, Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'Section of Inflammation, Repair and Development, National Heart & Lung Institute, Imperial College London, London, UK p.turner@imperial.ac.uk.'}]",Archives of disease in childhood,['10.1136/archdischild-2020-319906']
3169,32948554,Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.,"INTRODUCTION


Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
METHODS AND ANALYSIS


The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ 2  test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020.
ETHICS AND DISSEMINATION


The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03787732.",2020,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","['13 academic intensive care units in the USA', 'patients receiving positive pressure ventilation during tracheal intubation', '1065 critically ill adults undergoing tracheal intubation with planned use of', 'critically ill adults']","['intravenous fluid bolus', 'fluid REsuscitation', 'positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus', 'fluid REsuscitation during Induction and Intubation']","['cardiovascular collapse', '28-day in-hospital mortality', 'cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",1065.0,0.64588,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","[{'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA dwrussell@uabmc.edu.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Dargin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Shekhar', 'Initials': 'S', 'LastName': 'Ghamande', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Simanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Janna S', 'Initials': 'JS', 'LastName': 'Landsperger', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Robison', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Olivia F', 'Initials': 'OF', 'LastName': 'Krol', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brewer', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036671']
3170,32948579,"Correction: Efficacy of  Bifidobacterium animalis  subsp. lactis (BB-12), B.  infantis  and  Lactobacillus acidophilus  (La-5) probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study Protocol.",,2020,,['preterm infants of 28+0-32+6 weeks of gestation'],"['placebo', 'Bifidobacterium animalis  subsp']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",[],,0.392847,,[],BMJ open,['10.1136/bmjopen-2019-032617corr1']
3171,32948800,Effect of acute physical exercise on motor sequence memory.,"Acute physical exercise improves memory functions by increasing neural plasticity in the hippocampus. In animals, a single session of physical exercise has been shown to boost anandamide (AEA), an endocannabinoid known to promote hippocampal plasticity. Hippocampal neuronal networks encode episodic memory representations, including the temporal organization of elements, and can thus benefit motor sequence learning. While previous work established that acute physical exercise has positive effects on declarative memory linked to hippocampal plasticity mechanisms, its influence on memory for motor sequences, and especially on neural mechanisms underlying possible effects, has been less investigated. Here we studied the impact of acute physical exercise on motor sequence learning, and its underlying neurophysiological mechanisms in humans, using a cross-over randomized within-subjects design. We measured behavior, fMRI activity, and circulating AEA levels in fifteen healthy participants while they performed a serial reaction time task before and after a short period of exercise (moderate or high intensity) or rest. We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise. This enhancement correlated with AEA increase, and dovetailed with local increases in caudate nucleus and hippocampus activity. These findings demonstrate that acute physical exercise promotes sequence learning, thus attesting the overarching benefit of exercise to hippocampus-related memory functions.",2020,"We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise.",['fifteen healthy participants while they performed a serial reaction time task before and after a short period of exercise (moderate or high intensity) or rest'],"['acute physical exercise', 'physical exercise', 'Acute physical exercise']","['motor sequence memory', 'behavior, fMRI activity, and circulating AEA levels', 'caudate nucleus and hippocampus activity', 'memory functions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0425946', 'cui_str': 'Short menstrual periods'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007461', 'cui_str': 'Caudate nucleus structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",15.0,0.0360965,"We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Marin Bosch', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland. blanca.marinbosch@unige.ch.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Bringard', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Logrieco', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lauer', 'Affiliation': 'Unit of Toxicology, CURML, Lausanne University Hospital and Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Imobersteg', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Unit of Toxicology, CURML, Lausanne University Hospital and Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferretti', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Igloi', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-72108-1']
3172,32948827,"Hypertension treatment with Combretum micranthum or Hibiscus sabdariffa, as decoction or tablet: a randomized clinical trial.","Hibiscus sabdariffa L. (local names: bissap, karkade) and Combretum micranthum (kinkeliba) are widely known in traditional medicines and popular beliefs for their antihypertensive effect. This study assessed the clinical effectiveness of these two plants in the galenic forms of tablet and brew (decoction) in noncomplicated hypertensive patients. In total, 219 hypertensive patients with systolic blood pressure (SBP) between 140 and 180 mmHg and/or diastolic blood pressure (DBP) between 90 and 110 mmHg, without cardiovascular or renal complications, were involved in a multicentric randomized clinical trial in Senegal comparing five treatment regimens: bissap tablets (2 × 375 mg/day), bissap brew (10 g of calyx/day), kinkeliba tablets (2 × 200 mg/day), kinkeliba brew (10 g of leaves/day), and captopril (2 × 50 mg/day) as control. During the 6 months' follow-up, a significant and equivalent decrease of SBP was observed with the herbal drug approach (-19.5 ± 16.1 mmHg, p < 0.001) and control group (-19.7 ± 16.7, p < 0.001). Regarding the galenic forms, the brews tended to be slightly more effective than tablets (reduction of SBP: -20.7 ± 15.1 mmHg vs -18.7 ± 16.7). The rates of clinically significant effectiveness (decrease in SBP ≥ 10 mmHg) were 75%, 67%, and 65% with bissap, kinkeliba, and captopril, respectively. After 6 months, target blood pressure of <140/90 mmHg was attained by 49% of patients with bissap, 51% with kinkeliba and 40% with captopril. Bissap and kinkeliba appeared, at doses utilized, to be as effective as captopril over the 6 months' follow-up. In subsequent studies, brews might be started with a lower dosage.",2020,"During the 6 months' follow-up, a significant and equivalent decrease of SBP was observed with the herbal drug approach (-19.5 ± 16.1 mmHg, p < 0.001) and control group (-19.7 ± 16.7, p < 0.001).","['219 hypertensive patients with systolic blood pressure (SBP) between 140 and 180\u2009mmHg and/or diastolic blood pressure (DBP) between 90 and 110\u2009mmHg, without cardiovascular or renal complications', 'noncomplicated hypertensive patients']","['tablet and brew (decoction', 'bissap brew (10\u2009g of calyx/day), kinkeliba tablets', 'bissap tablets', 'captopril', 'Hibiscus sabdariffa L', 'Combretum micranthum or Hibiscus sabdariffa, as decoction or tablet']","['target blood pressure', 'SBP']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0022651', 'cui_str': 'Renal calyx'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C1207898', 'cui_str': 'Roselle'}, {'cui': 'C0969735', 'cui_str': 'Combretum'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",219.0,0.0284132,"During the 6 months' follow-up, a significant and equivalent decrease of SBP was observed with the herbal drug approach (-19.5 ± 16.1 mmHg, p < 0.001) and control group (-19.7 ± 16.7, p < 0.001).","[{'ForeName': 'Angélique', 'Initials': 'A', 'LastName': 'Bourqui', 'Affiliation': 'Antenna Foundation, Avenue de la Grenade 24, 1207, Genève, Switzerland. bourqui.angelique@gmail.com.'}, {'ForeName': 'ElHadji Atou Boye', 'Initials': 'EAB', 'LastName': 'Niang', 'Affiliation': 'UFR des Sciences de la Santé, Université Gaston Berger, BP 234 Route de Ngallèle, Saint-Louis, Senegal.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Graz', 'Affiliation': 'Antenna Foundation, Avenue de la Grenade 24, 1207, Genève, Switzerland.'}, {'ForeName': 'ElHadji Assane', 'Initials': 'EA', 'LastName': 'Diop', 'Affiliation': 'UFR des Sciences de la Santé, Université Gaston Berger, BP 234 Route de Ngallèle, Saint-Louis, Senegal.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Dahaba', 'Affiliation': 'Hôpital Matlaboul Fawzainy, Touba, Senegal.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Thiaw', 'Affiliation': 'Centre de Santé de Guéoul, Saint-Louis, Senegal.'}, {'ForeName': 'Khady', 'Initials': 'K', 'LastName': 'Soumare', 'Affiliation': 'Centre de Santé de Guéoul, Saint-Louis, Senegal.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Valmaggia', 'Affiliation': 'Antenna Foundation, Avenue de la Grenade 24, 1207, Genève, Switzerland.'}, {'ForeName': 'Renata Campos', 'Initials': 'RC', 'LastName': 'Nogueira', 'Affiliation': 'Antenna Foundation, Avenue de la Grenade 24, 1207, Genève, Switzerland.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Cavin', 'Affiliation': 'Antenna Foundation, Avenue de la Grenade 24, 1207, Genève, Switzerland.'}, {'ForeName': 'Marwah', 'Initials': 'M', 'LastName': 'Al-Anbaki', 'Affiliation': 'Antenna Foundation, Avenue de la Grenade 24, 1207, Genève, Switzerland.'}, {'ForeName': 'Sidy Mohamed', 'Initials': 'SM', 'LastName': 'Seck', 'Affiliation': 'UFR des Sciences de la Santé, Université Gaston Berger, BP 234 Route de Ngallèle, Saint-Louis, Senegal.'}]",Journal of human hypertension,['10.1038/s41371-020-00415-1']
3173,32948833,Combined inferior alveolar nerve block anaesthesia and local infiltration anaesthesia in extraction of impacted mandibular third molars: a randomised controlled trial.,"Aim To compare the anaesthetic effect of combination of inferior alveolar nerve block anaesthesia and local infiltration anaesthesia with nerve block anaesthesia techniques in the extraction of mandibular third molars.Materials and methods One hundred and fifty healthy adult volunteers were divided into three groups and were administered three different local anaesthetic techniques before tooth extractions: group A (inferior alveolar nerve, lingual nerve and buccal nerve block anaesthesia with lidocaine), group B (inferior alveolar nerve, lingual nerve and buccal nerve block anaesthesia with mepivacaine) and group C (inferior alveolar nerve block anaesthesia with lidocaine and infiltration anaesthesia with mepivacaine). The patients' reported pain on anaesthesia injection and tooth extraction, the surgeon's assessment of anaesthetic effect, the severity of intra-operative bleeding and post-operative complications were evaluated.Results There was no significant difference in visual analogue scale (VAS)-pain of anaesthesia among the three groups. Compared with groups A and B, group C had reduced VAS-pain of tooth extraction scores. Additionally, the surgeon's assessment of anaesthetic effect improved and intra-operative bleeding decreased.Conclusions The combination of inferior alveolar nerve block and infiltration anaesthesia provides a stronger anaesthetic effect in the extraction of mandibular third molars.",2020,The combination of inferior alveolar nerve block and infiltration anaesthesia provides a stronger anaesthetic effect in the extraction of mandibular third molars.,"['mandibular third molars', 'Materials and methods One hundred and fifty healthy adult volunteers', 'impacted mandibular third molars']","['Combined inferior alveolar nerve block anaesthesia and local infiltration anaesthesia', 'inferior alveolar nerve block anaesthesia and local infiltration anaesthesia with nerve block anaesthesia techniques', 'local anaesthetic techniques before tooth extractions: group A (inferior alveolar nerve, lingual nerve and buccal nerve block anaesthesia with lidocaine), group B (inferior alveolar nerve, lingual nerve and buccal nerve block anaesthesia with mepivacaine) and group C (inferior alveolar nerve block anaesthesia with lidocaine and infiltration anaesthesia with mepivacaine']","['visual analogue scale (VAS)-pain of anaesthesia', ""pain on anaesthesia injection and tooth extraction, the surgeon's assessment of anaesthetic effect, the severity of intra-operative bleeding and post-operative complications"", 'VAS-pain of tooth extraction scores', 'anaesthetic effect improved and intra-operative bleeding']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4285977', 'cui_str': 'Inferior alveolar nerve block anaesthesia'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}, {'cui': 'C0198802', 'cui_str': 'Nerve block anesthesia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0162406', 'cui_str': 'Structure of inferior alveolar nerve'}, {'cui': 'C0023740', 'cui_str': 'Structure of lingual nerve'}, {'cui': 'C0228737', 'cui_str': 'Structure of buccal nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",150.0,0.0676129,The combination of inferior alveolar nerve block and infiltration anaesthesia provides a stronger anaesthetic effect in the extraction of mandibular third molars.,"[{'ForeName': 'Zhicong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, Guangdong 510182, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, Guangdong 510182, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liao', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, Guangdong 510182, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, Guangdong 510182, China.'}, {'ForeName': 'Haiqiong', 'Initials': 'H', 'LastName': 'Yue', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, Guangdong 510182, China.'}, {'ForeName': 'Zhengguo', 'Initials': 'Z', 'LastName': 'Piao', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, Guangdong 510182, China.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou Key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, Guangdong 510182, China. fmmumario@126.com.'}]",British dental journal,['10.1038/s41415-020-2002-z']
3174,32057375,Sex-Specific Risks of Major Cardiovascular and Limb Events in Patients With Symptomatic Peripheral Artery Disease.,"BACKGROUND


Patients with peripheral artery disease (PAD) have a higher risk of major adverse cardiovascular events (MACE) compared with those without PAD.
OBJECTIVES


The aim of this post hoc analysis was to evaluate sex-specific differences in MACE and limb events in the EUCLID (Examining Use of Ticagrelor in PAD) trial.
METHODS


Cox proportional hazards models were used to compare time-to-event outcomes stratified by sex. Covariates were introduced after adjusted model selection.
RESULTS


EUCLID enrolled 13,885 patients with PAD (28% women [n = 3,888]). PAD severity and medical treatment were comparable between sexes, whereas prior lower extremity revascularization was reported less frequently in women (54.8% vs. 57.3%; p = 0.006). Women were older (mean ± SD age: 67.8 ± 8.9 vs. 66.1 ± 8.2 years; p < 0.001) and more likely to have diabetes mellitus (p = 0.004), hypertension, hyperlipidemia, and chronic kidney disease (all p < 0.001). Over a mean follow-up of 30 months, women had a lower risk of MACE (9.5% vs. 11.2%; adjusted hazard ratio: 0.77; 95% confidence interval: 0.68 to 0.88; p < 0.001) and all-cause-mortality (7.6% vs. 9.7%; adjusted hazard ratio: 0.61; 95% confidence interval: 0.53 to 0.71; p < 0.001). In contrast, risk for major adverse limb events (2.6% vs. 3.0%) and hospitalization for acute limb ischemia (1.6% vs. 1.7%) were not different by sex.
CONCLUSIONS


Although women with PAD are at lower risk for MACE and all-cause mortality, risk for limb events was similar between sexes over a mean follow-up of 30 months. Understanding sex-specific differences and dissociation between baseline cardiovascular risk and subsequent cardiovascular events requires further investigation. (A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease [EUCLID]; NCT01732822).",2020,"Although women with PAD are at lower risk for MACE and all-cause mortality, risk for limb events was similar between sexes over a mean follow-up of 30 months.","['Patients with peripheral artery disease (PAD', 'EUCLID enrolled 13,885 patients with PAD (28% women [n\xa0=\xa03,888', 'Patients With Peripheral Artery Disease [EUCLID', 'Patients With Symptomatic Peripheral Artery Disease']",['Ticagrelor and Clopidogrel'],"['extremity revascularization', 'hypertension, hyperlipidemia, and chronic kidney disease', 'lower risk of MACE', 'diabetes mellitus', 'risk for major adverse limb events', 'PAD severity and medical treatment', 'limb events', 'hospitalization for acute limb ischemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}]",13885.0,0.0697254,"Although women with PAD are at lower risk for MACE and all-cause mortality, risk for limb events was similar between sexes over a mean follow-up of 30 months.","[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haine', 'Affiliation': 'Swiss Cardiovascular Centre, Inselspital, Division of Angiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kavanagh', 'Affiliation': 'University of Colorado School of Medicine and CPC Clinical Research, Aurora, Colorado.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Departments of Medicine and Surgery, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'University of Colorado School of Medicine and CPC Clinical Research, Aurora, Colorado.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'F Gerry R', 'Initials': 'FGR', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Gaithersburg, Gaithersburg, Maryland.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'Heart Centre, Turku University Hospital, Turku, Finland; University of Turku, Turku, Finland.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine and CPC Clinical Research, Aurora, Colorado. Electronic address: Will.Hiatt@cpcmed.org.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Cardiovascular Centre, Inselspital, Division of Angiology, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.11.057']
3175,32946257,"Rationale, Theoretical Underpinnings, and Design of HEAR-aware: Providing Adults With Hearing Loss With Tailored Support to Self-Manage Their Hearing Problems via a Smartphone App, as an Alternative to Hearing Aids.","Purpose An alarming two thirds of adults aged 50 years or over with hearing impairment who could benefit from hearing aids do not own any, leaving these adults with no support to self-manage their hearing problems. In the HEAR-aware project, it is hypothesized that self-management can be facilitated via a smartphone app if its educational content is tailored to a person's dynamic stage of readiness to take action on their hearing (stage of change) and to a person's dynamic acoustical situations (as measured via a wearable microphone) and associated challenges (as captured via ecological momentary assessment). As such, the HEAR-aware app would be an ecological momentary intervention. This research note describes the rationale and theoretical underpinnings of the app, as well as the rationale for planning a series of studies to develop and evaluate it. Study Designs After a preparatory phase, Study 1 includes qualitative group interviews to assess user needs. Next, a creative session will be held, in which all stakeholders involved will work toward a specified version of the app. Subsequently, prototypes of the app will be developed and pilot-tested (Pilot Studies 2A and 2B). Users' usage and ratings (usability and quality indicators) of the app's elements will be examined and processed in the app. Lastly, the effectiveness of the app's final version will be examined in a randomized controlled trial (Study 3). Discussion The project's merits and challenges will be discussed.",2020,Users' usage and ratings (usability and quality indicators) of the app's elements will be examined and processed in the app.,"['adults aged 50 years or over with hearing impairment who could benefit from hearing aids do not own any, leaving these adults with no support to self-manage their hearing problems']",[],"[""Users' usage and ratings (usability and quality indicators""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",[],"[{'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0633229,Users' usage and ratings (usability and quality indicators) of the app's elements will be examined and processed in the app.,"[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Pronk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Besser', 'Affiliation': 'Sonova AG, Stäfa, Switzerland.'}, {'ForeName': 'Cas', 'Initials': 'C', 'LastName': 'Smits', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Feenstra-Kikken', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Beek', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Conny', 'Initials': 'C', 'LastName': 'Polleunis', 'Affiliation': 'Schoonenberg HoorSupport, Dordrecht, the Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Kramer', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}]",American journal of audiology,['10.1044/2020_AJA-19-00079']
3176,32946353,Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial.,"PURPOSE


We conducted the phase III double-blind European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial to evaluate pembrolizumab versus placebo in patients with resected high-risk stage III melanoma. On the basis of 351 recurrence-free survival (RFS) events at a 1.25-year median follow-up, pembrolizumab prolonged RFS (hazard ratio [HR], 0.57;  P  < .0001) compared with placebo. This led to the approval of pembrolizumab adjuvant treatment by the European Medicines Agency and US Food and Drug Administration. Here, we report an updated RFS analysis at the 3.05-year median follow-up.
PATIENTS AND METHODS


A total of 1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma were randomly assigned to receive pembrolizumab at a flat dose of 200 mg (n = 514) or placebo (n = 505) every 3 weeks for 1 year or until disease recurrence or unacceptable toxicity. The two coprimary end points were RFS in the overall population and in those with programmed death-ligand 1 (PD-L1)-positive tumors.
RESULTS


Pembrolizumab (190 RFS events) compared with placebo (283 RFS events) resulted in prolonged RFS in the overall population (3-year RFS rate, 63.7%  v  44.1% for pembrolizumab  v  placebo, respectively; HR, 0.56; 95% CI, 0.47 to 0.68) and in the PD-L1-positive tumor subgroup (HR, 0.57; 99% CI, 0.43 to 0.74). The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and  BRAF  mutation status (HR, 0.51 [99% CI, 0.36 to 0.73]  v  0.66 [99% CI, 0.46 to 0.95] for V600 E/K   v  wild type).
CONCLUSION


In resected high-risk stage III melanoma, pembrolizumab adjuvant therapy provided a sustained and clinically meaningful improvement in RFS at 3-year median follow-up. This improvement was consistent across subgroups.",2020,"The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and  BRAF  mutation status (HR, 0.51","['High-Risk Stage III Melanoma', 'Cancer (EORTC', 'patients with resected high-risk stage III melanoma', '1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma']","['pembrolizumab versus placebo', 'placebo', 'pembrolizumab', 'Adjuvant Pembrolizumab']","['351 recurrence-free survival (RFS) events', 'RFS', 'overall population (3-year RFS rate']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1019.0,0.783931,"The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and  BRAF  mutation status (HR, 0.51","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center, Utrecht, the Netherlands.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Meshcheryakov', 'Affiliation': 'N.N. Blokhin Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital and Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia, and The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic Universitari de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale,"" Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus J M', 'Initials': 'AJM', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, location VUMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, Quebec, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Saclay University, Villejuif, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02110']
3177,32946355,Consolidation Radiotherapy Could Be Safely Omitted in Advanced Hodgkin Lymphoma With Large Nodal Mass in Complete Metabolic Response After ABVD: Final Analysis of the Randomized GITIL/FIL HD0607 Trial.,"PURPOSE


To investigate the role of consolidation radiotherapy (cRT) in advanced-stage Hodgkin lymphoma (HL) presenting at baseline with a large nodal mass (LNM) in complete metabolic response after doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy.
PATIENTS AND METHODS


Advanced-stage (IIB-IVB) HL patients, enrolled in the HD 0607 trial (Clinicaltrial.gov identifier NCT00795613), with both a negative PET after two (PET-2) and six (PET-6) ABVD cycles, who presented at baseline with an LNM, defined as a nodal mass with the largest diameter ≥ 5 cm, were prospectively randomly assigned to receive cRT over the LNM or no further treatment (NFT).
RESULTS


Among 296 randomly assigned patients, the largest diameter of LNM at baseline was 5-7 cm in 101 (34%; subgroup A) and 8-10 cm in 96 (32%; subgroup B), whereas classic bulky (diameter > 10 cm) was detected in 99 (33%; subgroup C). Two hundred eighty patients (88%) showed a postchemotherapy RM. The median dose of cRT was 30.6 Gy (range, 24-36 Gy). After a median follow-up of 5.9 years (range, 0.5-10 years), the 6-year progression-free survival rate of patients who underwent cRT or NFT was, respectively, 91% (95% CI, 84% to 99%) and 95% (95% CI, 89% to 100%;  P  = .62) in subgroup A; 98% (95% CI, 93% to 100%) and 90% (95% CI, 80% to 100%;  P  = .24) in subgroup B; 89% (95% CI, 81% to 98%) and 86% (95% CI, 77% to 96%;  P  = .53) in subgroup C (classic bulky).
CONCLUSION


cRT could be safely omitted in patients with HL presenting with an LNM and a negative PET-2 and PET-6 scan, irrespective from the LNM size detected at baseline.",2020,"CONCLUSION


cRT could be safely omitted in patients with HL presenting with an LNM and a negative PET-2 and PET-6 scan, irrespective from the LNM size detected at baseline.","['Advanced-stage', 'patients with HL presenting with an LNM', 'advanced-stage Hodgkin lymphoma (HL) presenting at baseline with a large nodal mass (LNM) in complete metabolic response after', 'IIB-IVB) HL patients, enrolled in the HD 0607 trial (Clinicaltrial.gov identifier NCT00795613), with both a negative PET after two (PET-2) and six (PET-6) ABVD cycles, who presented at baseline with an LNM, defined as a nodal mass with the largest diameter ≥ 5 cm', 'Two hundred eighty patients (88%) showed a postchemotherapy RM', 'Advanced Hodgkin Lymphoma']","['doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy', 'NFT', 'Consolidation Radiotherapy', 'cRT over the LNM or no further treatment (NFT', 'consolidation radiotherapy (cRT']","['6-year progression-free survival rate', 'Complete Metabolic Response']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0050380', 'cui_str': 'ABVD-I protocol'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",296.0,0.392528,"CONCLUSION


cRT could be safely omitted in patients with HL presenting with an LNM and a negative PET-2 and PET-6 scan, irrespective from the LNM size detected at baseline.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallamini', 'Affiliation': 'Research and Clinical Innovation Department, A. Lacassagne Cancer Center, Nice, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Hematology, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Patti', 'Affiliation': 'Hematology, V. Cervello Hospital, Palermo, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Picardi', 'Affiliation': 'Hematology, Policlinico Federico II Hospital, Naples, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'Hematology, Policlinico Vittorio Emanuele Hospital, Catania, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cantonetti', 'Affiliation': 'Hematology, Policlinico Universitario Tor Vergata, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Oppi', 'Affiliation': 'Department of Hematology, Businco Hospital, Cagliari, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Viviani', 'Affiliation': 'Department of Hematology, IRCCS National Institute of Tumors, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bolis', 'Affiliation': 'Hematology, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Trentin', 'Affiliation': 'Hematology, Medicine, Padua University, Padua, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gini', 'Affiliation': 'Hematology, Ospedali Riuniti Le Torrette, Ancona, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Battistini', 'Affiliation': 'Hematology, San Camillo Forlanini Hospital, Rome, Italy.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Chauvie', 'Affiliation': 'Medical Physics Unit, Santa Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sorasio', 'Affiliation': 'Hematology, Santa Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pavoni', 'Affiliation': 'Hematology, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Zanotti', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cimminiello', 'Affiliation': 'Hematology, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Schiavotto', 'Affiliation': 'Hematology, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Piera', 'Initials': 'P', 'LastName': 'Viero', 'Affiliation': ""Hematology Ospedale dell'Angelo, Mestre, Venice, Italy.""}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Mulé', 'Affiliation': 'Hematology, V. Cervello Hospital, Palermo, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Fallanca', 'Affiliation': 'Nuclear Medicine Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Ficola', 'Affiliation': 'Nuclear Medicine Department, La Maddalena Hospital, Palermo, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Onco-Hematology European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Guerra', 'Affiliation': 'Nuclear Medicine, San Gerardo University Hospital, Monza, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Hematology, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00935']
3178,32946574,Pharmacodynamic activity of the novel neurokinin-3 receptor antagonist SJX-653 in healthy men.,"CONTEXT


SJX-653 is a novel neurokinin 3 receptor (NK3R) antagonist. The NK3 pathway is a central regulator of GnRH secretion and has also been implicated in the generation of hot flashes. Therefore decreases of LH and testosterone in men serve as sensitive pharmacodynamic (PD) markers of central NK3 antagonism.
OBJECTIVE


To characterize the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of SJX-653 in healthy men.
DESIGN


Randomized, placebo-controlled, double-blind, single ascending dose study.
SETTING


Phase 1 unit.
PATIENTS OR OTHER PARTICIPANTS


Seven cohorts of 6 healthy men 18-45 years (4:2 randomization to SJX-653/placebo per cohort).
INTERVENTION(S)


single oral doses of 0.5 to 90 mg SJX-653.
MAIN OUTCOME MEASURE(S)


Safety assessments and serial Pharmacokinetic (PK)/PD measurements.
RESULTS


SJX-653 was well tolerated at all dose levels. Cmax and AUC0-24 increased in a dose proportional manner. The terminal elimination half-life ranged between 9.8 and 12.5h independent of dose. A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg. Maximal LH reduction was 70±7% (mean±sd) at 6h after 30 mg SJX-653, versus 10±43% for placebo (p = 0.0006); maximal T reduction was of 68±5% at 8h after 60 mg SJX-653, versus 18±11% for placebo (p < 0.0001). The plasma IC50 for LH reduction was 33 ng/mL.
CONCLUSIONS


These data demonstrate clinical proof-of-mechanism for SJX-653 as a potent centrally-acting NK3R antagonist.",2020,"A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg.","['Phase 1 unit', 'healthy men', 'Seven cohorts of 6 healthy men 18-45 years (4:2 randomization to SJX-653/placebo per cohort']","['placebo', 'SJX-653', 'novel neurokinin-3 receptor antagonist SJX-653']","['LH and testosterone', 'Safety assessments and serial Pharmacokinetic (PK)/PD measurements', 'Maximal LH reduction', 'plasma IC50 for LH reduction', 'Pharmacodynamic activity', 'Cmax and AUC0-24', 'tolerated', 'safety, tolerability, pharmacokinetics, and pharmacodynamic activity', 'maximal T reduction']","[{'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0600495', 'cui_str': 'IC50'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",6.0,0.170922,"A statistically significant, dose-dependent, reversible reduction of LH and testosterone was observed with near maximal effect after 15 mg and little to no effect at 4.5 mg.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cormier', 'Affiliation': 'Sojournix, Inc., Waltham, MA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Thieroff-Ekerdt', 'Affiliation': 'Sojournix, Inc., Waltham, MA, USA.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Boyce', 'Affiliation': 'Hammersmith Medicines Research, London, UK.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'van den Berg', 'Affiliation': 'Hammersmith Medicines Research, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grau', 'Affiliation': 'Sojournix, Inc., Waltham, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turnquist', 'Affiliation': 'Sojournix, Inc., Waltham, MA, USA.'}, {'ForeName': 'Deya', 'Initials': 'D', 'LastName': 'Corzo', 'Affiliation': 'Sojournix, Inc., Waltham, MA, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Graham', 'Affiliation': 'Sojournix, Inc., Waltham, MA, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa657']
3179,32946590,Periodontal Regeneration using a Xenogeneic Bone Substitute seeded with Autologous Periodontal Ligament derived Mesenchymal Stem Cells: a 12-month quasi-randomized controlled pilot clinical trial.,"AIM


To evaluate the safety and efficacy of autologous periodontal ligament-derived mesenchymal stem cells (PDL-MSCs) embedded in a xenogeneic bone substitute (XBS) for the regenerative treatment of intra-bony periodontal defects.
MATERIAL AND METHODS


This quasi-randomized controlled pilot phase II clinical trial included patients requiring a tooth extraction and presence of one intra-bony lesion (1-2 walls). Patients were allocated to either the experimental (XBS + 10x10 6  PDL-MSCs/100mg) or the control group (XBS). Clinical and radiographical parameters were recorded at baseline, 6, 9 and 12 months. The presence of adverse events was also evaluated. Chi-square, Student`s t-test, U-Mann Whitney, repeated-measures ANOVA and regression models were used.
RESULTS


Twenty patients were included. No serious adverse events were reported. Patients in the experimental group (n=9) showed greater clinical attachment level (CAL) gain [1.44, standard deviation (SD)=1.87] and probing pocket depth (PPD) reduction (2.33, SD=1.32) than the control group (n=10; CAL gain=0.88, SD=1.68, and PPD reduction=2.10, SD=2.46), without statistically significant differences.
CONCLUSION


The application of PDL-MSCs to XBS for the treatment of one-two wall intra-bony lesions was safe and resulted in low postoperative morbidity and appropriate healing, although its additional benefit, when compared with the XBS alone, was not demonstrated.",2020,"Patients in the experimental group (n=9) showed greater clinical attachment level (CAL) gain [1.44, standard deviation (SD)=1.87] and probing pocket depth (PPD) reduction (2.33, SD=1.32) than the control group (n=10; CAL","['patients requiring a tooth extraction and presence of one intra-bony lesion (1-2 walls', 'Twenty patients were included']","['autologous periodontal ligament-derived mesenchymal stem cells (PDL-MSCs', 'experimental (XBS + 10x10 6  PDL-MSCs/100mg) or the control group (XBS', 'Xenogeneic Bone Substitute seeded with Autologous Periodontal Ligament derived Mesenchymal Stem Cells', 'CAL']","['safety and efficacy', 'adverse events', 'clinical attachment level (CAL) gain', 'probing pocket depth (PPD) reduction', 'Clinical and radiographical parameters', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227089', 'cui_str': 'Structure of deciduous maxillary right second molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0031093', 'cui_str': 'Periodontal ligament'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",20.0,0.0751446,"Patients in the experimental group (n=9) showed greater clinical attachment level (CAL) gain [1.44, standard deviation (SD)=1.87] and probing pocket depth (PPD) reduction (2.33, SD=1.32) than the control group (n=10; CAL","[{'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Sánchez', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Fierravanti', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Vignoletti', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'González-Zamora', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Santamaría', 'Affiliation': 'Margarita Salas Center for Biological Research (CIB-CSIC), Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Suárez-Sancho', 'Affiliation': 'GMP-Cell Production Unit. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM). Red de Terapia Celular (TERCEL) and CIBER Cardiovascular (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'María Eugenia', 'Initials': 'ME', 'LastName': 'Fernández-Santos', 'Affiliation': 'GMP-Cell Production Unit. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM). Red de Terapia Celular (TERCEL) and CIBER Cardiovascular (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Figuero', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herrera', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'García-Sanz', 'Affiliation': 'Margarita Salas Center for Biological Research (CIB-CSIC), Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}]",Journal of clinical periodontology,['10.1111/jcpe.13368']
3180,32946612,"Intradermal Phleum pratense allergoid immunotherapy. Double-blind, randomised, placebo-controlled trial.","BACKGROUND


In allergology, the intradermal approach is generally used to establish an etiological diagnosis, with limited experience in specific allergen immunotherapy.
OBJECTIVE


To evaluate the efficacy and safety of immunotherapy with an allergen extract of glutaraldehyde-polymerised Phleum pratense, administered intradermally, in patients with rhinoconjunctivitis sensitized to grass pollen.
METHODS


Multicentre, randomised, double-blind, placebo-controlled clinical trial in patients from 12 to 65 years of age with rhinitis or rhinoconjunctivitis, with or without asthma, due to grass pollen allergy. Patients were divided into three groups and received a total of 6 doses in a weekly interval, of either placebo; 0.03 μg or 0.06 μg of protein per dose of Phleum pratense allergoid. The primary objective was to evaluate the combined symptoms and medication consumption score (CSMS). The secondary objectives were symptoms and medication, tolerance to the conjunctival provocation test, specific IgE and IgG4 antibodies and the safety profile according to the WAO scale.
RESULTS


The dose of 0.06 μg of protein proved to be effective versus the placebo by significantly reducing CSMS and increasing tolerance to the allergenic extract in the conjunctival provocation test, after the first pollen season. This group showed a significant reduction in specific IgE after the second pollen season relative to the baseline. There were no variations in IgG4 levels. Only one grade 2 systemic reaction was recorded.
CONCLUSION & CLINICAL RELEVANCE


Intradermal immunotherapy with P. pratense allergoid has been shown to be effective and safe, reducing CSMS, increasing tolerance to the conjunctival provocation test and reducing IgE levels.",2020,"CONCLUSION & CLINICAL RELEVANCE


Intradermal immunotherapy with P. pratense allergoid has been shown to be effective and safe, reducing CSMS, increasing tolerance to the conjunctival provocation test and reducing IgE levels.","['patients from 12 to 65 years of age with rhinitis or rhinoconjunctivitis, with or without asthma, due to grass pollen allergy', 'patients with rhinoconjunctivitis sensitized to grass pollen']","['glutaraldehyde-polymerised Phleum pratense', 'immunotherapy', 'placebo; 0.03 μg or 0.06 μg of protein per dose of Phleum pratense allergoid', 'placebo', 'Intradermal Phleum pratense allergoid immunotherapy']","['grade 2 systemic reaction', 'combined symptoms and medication consumption score (CSMS', 'efficacy and safety', 'IgG4 levels', 'symptoms and medication, tolerance to the conjunctival provocation test, specific IgE and IgG4 antibodies and the safety profile according to the WAO scale', 'specific IgE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0740919', 'cui_str': 'Allergy to grass pollen'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}]","[{'cui': 'C0017814', 'cui_str': 'Glutaral'}, {'cui': 'C1123001', 'cui_str': 'Phleum pratense'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0051199', 'cui_str': 'Allergoid'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}]","[{'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020860', 'cui_str': 'Immunoglobulin IgG4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0430565', 'cui_str': 'Ophthalmic mucous membrane test'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.45433,"CONCLUSION & CLINICAL RELEVANCE


Intradermal immunotherapy with P. pratense allergoid has been shown to be effective and safe, reducing CSMS, increasing tolerance to the conjunctival provocation test and reducing IgE levels.","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Sola Martínez', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Ruth María', 'Initials': 'RM', 'LastName': 'Barranco Jiménez', 'Affiliation': 'Hospital Universitario, 12 de Octubre, Madri, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martín García', 'Affiliation': 'Hospital Virgen de la Concha, Zamora, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Senent Sánchez', 'Affiliation': 'Hospital Virgen del Valle, Toledo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Blanco Guerra', 'Affiliation': 'Hospital Universitario de La Princesa, Instituto de investigación Sanitaria Princesa, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'Hospital Clínico San Carlos, Universidad Complutense, IdISSC, ARADyAL, Madrid, Spain.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Vega Castro', 'Affiliation': 'Hospital Universitario de Guadalajara, Guadalajara, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Dávila González', 'Affiliation': 'Hospital Universitario de Salamanca, Salamanca. Department of Biomedical and Diagnostic Sciences, Faculty of Medicine, University of Salamanca. Institute for Biomedical Research of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carbonell Martínez', 'Affiliation': 'Hospital General Universitario Reina Sofía, Murcia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Panizo Bravo', 'Affiliation': 'Hospital Virgen del Prado, Talavera de la Reina. Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gómez Torrijos', 'Affiliation': 'Hospital Universitario de Ciudad Real. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez Gil', 'Affiliation': 'Diater Laboratorios S.A, Leganés, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios Peláez', 'Affiliation': 'Diater Laboratorios S.A, Leganés, Madrid, Spain.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13740']
3181,32946618,"Expression of HGF, pMet, and pAkt is related to benefit of radiotherapy after breast-conserving surgery: A long-term follow-up of the SweBCG91-RT randomised trial.","Experimental studies suggest that hepatocyte growth factor (HGF) and its transmembrane tyrosine kinase receptor, Met, in part also relying on Akt kinase activity, mediate radioresistance. We investigated the importance of these biomarkers for the risk of ipsilateral breast tumour recurrence (IBTR) after adjuvant radiotherapy (RT) in primary breast cancer. HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT. HGF was evaluated in the stroma (HGF str  ); pMet in the membrane (pMet mem  ); HGF, pMet, and pAkt in the cytoplasm (HGF cyt  , pMet cyt  , pAkt cyt  ); and pAkt in the nucleus (pAkt nuc  ). The prognostic and treatment predictive effects were evaluated to primary endpoint IBTR as first event during the first five years. Patients with tumours expressing low levels of HGF cyt  and pMet cyt  and high levels of pAkt nuc  derived a larger benefit from RT (hazard ratio [HR]: 0.11 [0.037-0.30], 0.066 [0.016-0.28], and 0.094 [0.028-0.31], respectively) compared to patients with high expression of HGF cyt  and pMet cyt  , and low pAkt nuc  (HR: 0.36 [0.19-0.67], 0.35 [0.20-0.64], and 0.47 [0.32-0.71], respectively; interaction analyses: p=0.052, 0.035, and 0.013 respectively). These differences remained in multivariable analysis when adjusting for patient age, tumour size, histological grade, St Gallen subtype, and systemic treatment (interaction analysis, p-values: 0.085, 0.027, and 0.023, respectively). This study suggests that patients with immunohistochemically low HGF cyt  , low pMet cyt  , and high pAkt nuc  may derive an increased benefit from RT after breast-conserving surgery concerning the risk of developing IBTR.",2020,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","['primary breast cancer', 'patients with immunohistochemically low HGF cyt  , low pMet cyt  , and high pAkt nuc']","['breast-conserving therapy, with or without adjuvant RT', 'radiotherapy', 'adjuvant radiotherapy (RT', 'hepatocyte growth factor (HGF']",['HGF'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]","[{'cui': 'C0062534', 'cui_str': 'Scatter Factor'}]",,0.0359245,"HGF, phosphorylated Met (pMet), and phosphorylated Akt (pAkt) were evaluated immunohistochemically on tissue microarrays from 1,004 patients in the SweBCG91-RT trial, which randomly assigned patients to breast-conserving therapy, with or without adjuvant RT.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Faculty of Medicine Division of Oncology and Pathology, Department of Clinical Sciences, Lund University Sweden, Lund, Sweden.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Veenstra', 'Affiliation': 'Department of Biomedical and Clinical Sciences and Department of Oncology, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology Institute of Clinical Sciences, Sahlgrenska Academy University of Gothenburg Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology Institute of Clinical Sciences, Sahlgrenska Academy University of Gothenburg Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Faculty of Medicine Division of Oncology and Pathology, Department of Clinical Sciences, Lund University Sweden, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Faculty of Medicine Division of Oncology and Pathology, Department of Clinical Sciences, Lund University Sweden, Lund, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Niméus', 'Affiliation': 'Faculty of Medicine Division of Oncology and Pathology, Department of Clinical Sciences, Lund University Sweden, Lund, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Faculty of Medicine Division of Oncology and Pathology, Department of Clinical Sciences, Lund University Sweden, Lund, Sweden.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Stål', 'Affiliation': 'Department of Biomedical and Clinical Sciences and Department of Oncology, Linköping University, Linköping, Sweden.'}]",Molecular oncology,['10.1002/1878-0261.12803']
3182,32946679,Comparison of shear bond strengths with different bevel preparations for the re-attachment of fractured fragments of maxillary central incisors.,"BACKGROUND/AIMS


Fractures of anterior teeth are a highly prevalent form of dental trauma. Among the various treatment options, reattachment of the fractured part to the remaining tooth has a lot of advantages. The aim of this study was to compare different bevel preparation techniques when reattaching fractured fragments to maxillary central incisors.
METHODS


This study was performed on 52 maxillary central incisors that were randomly divided into 3 experimental groups and 1 control group. In the control group, repair was done by attaching the fractured fragment using bonding and composite resin without any bevel preparation. In the second and third groups, the bevel preparation was done to a depth of 0.5 mm before attachment of the fragment on the palatal side of the fracture and on the labial and palatal sides, respectively. In the fourth group, after tooth preparation, a 0.5 mm composite veneer was placed on the labial surface. The amount of force needed to re-fracture the tooth was measured with a universal testing machine and shear bond strength was calculated in MPa.
RESULTS


Mean and standard deviation (mean±SD) of shear bond strengths in the control group was 81.48± 8.18 MPa. In the palatal bevel group, it was 97.74± 11.41 MPa, in the labial and palatal bevel group it was 131.56± 9.25 MPa and in the composite veneer group it was 104.36± 5.50 MPa. Significant differences were observed between the groups, but there was no significant difference between the palatal bevel and composite veneer groups.
CONCLUSIONS


Reattachment of the fractured fragments by all three methods increased the shear bond strength. The highest shear bond strength was obtained when both labial and palatal bevels were used.",2020,"Significant differences were observed between the groups, but there was no significant difference between the palatal bevel and composite veneer groups.
","['fractured fragments of maxillary central incisors', '52 maxillary central incisors']",[],"['shear bond strength', 'Mean and standard deviation (mean±SD) of shear bond strengths', 'highest shear bond strength']","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]",[],"[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205250', 'cui_str': 'High'}]",52.0,0.0392918,"Significant differences were observed between the groups, but there was no significant difference between the palatal bevel and composite veneer groups.
","[{'ForeName': 'Arezou', 'Initials': 'A', 'LastName': 'Ghoreishizadeh', 'Affiliation': 'Department of Pediatric, faculty of dentistry, Tabriz University of medical sciences, Tabriz, Iran.'}, {'ForeName': 'Foorough', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Pediatric, faculty of dentistry, Tabriz University of medical sciences, Tabriz, Iran.'}, {'ForeName': 'Yashar', 'Initials': 'Y', 'LastName': 'Rezayi', 'Affiliation': 'Dental and Periodontal Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Ghavimi', 'Affiliation': 'Department of Oral and maxillofacial surgery, faculty of dentistry, Tabriz university of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Pourlak', 'Affiliation': 'Department of Oral and maxillofacial surgery, faculty of dentistry, Tabriz university of Medical Sciences, Tabriz, Iran.'}]",Dental traumatology : official publication of International Association for Dental Traumatology,['10.1111/edt.12605']
3183,31863339,Is the Peer Presence Effect on Heightened Adolescent Risky Decision-Making only Present in Males?,"Social neurodevelopmental imbalance models posit that peer presence causes heightened adolescent risk-taking particularly during early adolescence. Evolutionary theory suggests that these effects would be most pronounced in males. However, the small but growing number of experimental studies on peer presence effects in adolescent risky decision-making showed mixed findings, and the vast majority of such studies did not test for the above-described gender and adolescent phase moderation effects. Moreover, most of those studies did not assess the criterion validity of the employed risky decision-making tasks. The current study was designed to investigate the abovementioned hypotheses among a sample of 327 ethnically-diverse Dutch early and mid-adolescents (49.80% female; M age  = 13.61). No main effect of peer presence on the employed risky-decision making task (i.e., the stoplight game) was found. However, the results showed a gender by peer presence moderation effect. Namely, whereas boys and girls engaged in equal levels of risks when they completed the stoplight game alone, boys engaged in more risk-taking than girls when they completed this task together with two same-sex peers. In contrast, adolescent phase did not moderate peer presence effects on risk-taking. Finally, the results showed that performance on the stoplight game predicted self-reported real-world risky traffic behavior, alcohol use and delinquency. Taken together, using a validated task, the present findings demonstrate that individual differences (i.e., gender) can determine whether the social environment (i.e., peer presence) affect risk-taking in early- and mid-adolescents. The finding that performance on a laboratory risky decision-making task can perhaps help identify adolescents that are vulnerable to diverse types of heightened risk behaviors is an important finding for science as well as prevention and intervention efforts.",2020,"No main effect of peer presence on the employed risky-decision making task (i.e., the stoplight game) was found.",['327 ethnically-diverse Dutch early and mid-adolescents (49.80% female; M age \u2009=\u200913.61'],[],"['stoplight game predicted self-reported real-world risky traffic behavior, alcohol use and delinquency']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0022438', 'cui_str': 'Juvenile Delinquency'}]",327.0,0.0152068,"No main effect of peer presence on the employed risky-decision making task (i.e., the stoplight game) was found.","[{'ForeName': 'Ivy N', 'Initials': 'IN', 'LastName': 'Defoe', 'Affiliation': 'University of Amsterdam, Postbus 15776, 1001 NG, Amsterdam, The Netherlands. i.n.defoe@uva.nl.'}, {'ForeName': 'Judith Semon', 'Initials': 'JS', 'LastName': 'Dubas', 'Affiliation': 'Developmental Psychology, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Edwin S', 'Initials': 'ES', 'LastName': 'Dalmaijer', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Marcel A G', 'Initials': 'MAG', 'LastName': 'van Aken', 'Affiliation': 'Developmental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",Journal of youth and adolescence,['10.1007/s10964-019-01179-9']
3184,32946372,Transvenous phrenic nerve stimulation to treat idiopathic central sleep apnea.,"STUDY OBJECTIVES


Idiopathic central sleep apnea (ICSA) is a rare disorder diagnosed when known causes of CSA are excluded. No established treatments exist for ICSA and long-term studies are lacking. We assessed long-term effectiveness and safety of transvenous phrenic nerve stimulation (TPNS) in patients with ICSA.
METHODS


In the remedē System Pivotal Trial, 16/151 (11%) participants with CSA were diagnosed as ICSA. Patients were implanted and followed through 18 months of active therapy. Polysomnograms obtained at baseline, 6, 12 and 18-months were scored by a central laboratory. Sleep metrics and patient-reported quality of life (QoL) outcomes were assessed.
RESULTS


Patients suffered from moderate-severe CSA. Baseline apnea-hypopnea index (AHI), central apnea index (CAI) and arousal index (ArI) were 40, 25 and 32 events/hour of sleep, respectively. These metrics improved at 6, 12 and 18 months of therapy: AHI decreased by 25, 25 and 23 events/hour (p<.001 at each visit), CAI by 22, 23 and 22 events/hour (p<.001 at each visit), and ArI by 12 (p=0.005 ), 11 ( p=0.035) and 13 events/hour (p<.001). QoL instruments demonstrated clinically meaningful improvements in daytime somnolence, fatigue, general and mental health, and social functioning. The only related serious adverse event was lead component failure in one subject.
CONCLUSIONS


This is the longest prospective study for treatment of ICSA. TPNS significantly decreased sleep disordered breathing metrics with consequent improvement in QoL at 6 months, and all benefits were sustained through 18 months.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Respicardia, Inc. Pivotal Trial of the remedē System; Identifier: NCT01816776.",2020,"QoL instruments demonstrated clinically meaningful improvements in daytime somnolence, fatigue, general and mental health, and social functioning.","['patients with ICSA', 'idiopathic central sleep apnea', 'Idiopathic central sleep apnea (ICSA']","['ICSA', 'transvenous phrenic nerve stimulation (TPNS', 'Transvenous phrenic nerve stimulation', 'TPNS']","['Sleep metrics and patient-reported quality of life (QoL) outcomes', 'Baseline apnea-hypopnea index (AHI), central apnea index (CAI) and arousal index (ArI', 'sleep disordered breathing metrics', 'daytime somnolence, fatigue, general and mental health, and social functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}]","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C2219848', 'cui_str': 'Daytime somnolence'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.103838,"QoL instruments demonstrated clinically meaningful improvements in daytime somnolence, fatigue, general and mental health, and social functioning.","[{'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': 'Division of Pulmonary and Sleep Medicine, Bethesda North Hospital, Cincinnati, Ohio.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McKane', 'Affiliation': 'Respicardia, Inc., Minnetonka, Minnesota.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8802']
3185,32946451,Comparative functional survival and equivalent annual cost of 3 long-lasting insecticidal net (LLIN) products in Tanzania: A randomised trial with 3-year follow up.,"BACKGROUND


Two billion long-lasting insecticidal nets (LLINs) have been procured for malaria control. A functional LLIN is one that is present, is in good physical condition, and remains insecticidal, thereby providing protection against vector-borne diseases through preventing bites and killing disease vectors. The World Health Organization (WHO) prequalifies LLINs that remain adequately insecticidal 3 years after deployment. Therefore, institutional buyers often assume that prequalified LLINs are functionally identical with a 3-year lifespan. We measured the lifespans of 3 LLIN products, and calculated their cost per year of functional life, to demonstrate the economic and public health importance of procuring the most cost-effective LLIN product based on its lifespan.
METHODS AND FINDINGS


A randomised double-blinded trial of 3 pyrethroid LLIN products (10,571 nets in total) was conducted at 3 follow-up points: 10 months (August-October 2014), 22 months (August-October 2015), and 36 months (October-December 2016) among 3,393 households in Tanzania using WHO-recommended methods. Primary outcome was LLIN functional survival (LLIN present and in serviceable condition). Secondary outcomes were (1) bioefficacy and chemical content (residual insecticidal activity) and (2) protective efficacy for volunteers sleeping under the LLINs (bite reduction and mosquitoes killed). Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR] 0.73 [95% CI 0.64-0.85], p = 0.001), and 2.6 years (95% CI 2.3-2.8) for NetProtect (HR = 0.70 [95% CI 0.62-0.77], p < 0.001). Functional survival was affected by accumulation of holes, leading to users discarding nets. Protective efficacy also significantly differed between products as they aged. Equivalent annual cost varied between US$1.2 (95% CI $1.1-$1.4) and US$1.5 (95% CI $1.3-$1.7), assuming that each net was priced identically at US$3. The 2 longer-lived nets (PermaNet and NetProtect) were 20% cheaper than the shorter-lived product (Olyset). The trial was limited to only the most widely sold LLINs in Tanzania. Functional survival varies by country, so the single country setting is a limitation.
CONCLUSIONS


These results suggest that LLIN functional survival is less than 3 years and differs substantially between products, and these differences strongly influence LLIN value for money. LLIN tendering processes should consider local expectations of cost per year of functional life and not unit price. As new LLIN products come on the market, especially those with new insecticides, it will be imperative to monitor their comparative durability to ensure that the most cost-effective products are procured for malaria control.",2020,"Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR]","['3,393 households in Tanzania using WHO-recommended methods', 'Tanzania', '10,571 nets in total']","['pyrethroid LLIN products', '3 long-lasting insecticidal net (LLIN']","['Protective efficacy', 'Median LLIN functional survival', 'LLIN functional survival (LLIN present and in serviceable condition', 'Equivalent annual cost', 'LLIN functional survival', 'Functional survival', 'bioefficacy and chemical content (residual insecticidal activity) and (2) protective efficacy for volunteers sleeping under the LLINs (bite reduction and mosquitoes killed']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0597329', 'cui_str': 'Pyrethroid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243177', 'cui_str': 'chemical content'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0162388', 'cui_str': 'Killing'}]",3.0,0.315453,"Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR]","[{'ForeName': 'Lena M', 'Initials': 'LM', 'LastName': 'Lorenz', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Massue', 'Affiliation': 'National Institute for Medical Research, Amani Research Centre, Muheza, Tanzania.'}, {'ForeName': 'Zawadi', 'Initials': 'Z', 'LastName': 'Mageni Mboma', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pigeon', 'Affiliation': 'Plant Protection Products and Biocides Physico-chemistry and Residues Unit, Agriculture and Natural Environment Department, Walloon Agricultural Research Centre, Gembloux, Belgium.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Vector Control Product Testing Unit, Ifakara Health Institute, Bagamoyo, Tanzania.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Kilian', 'Affiliation': 'Tropical Health, Montagut, Spain.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Lines', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kisinza', 'Affiliation': 'National Institute for Medical Research, Amani Research Centre, Muheza, Tanzania.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Overgaard', 'Affiliation': 'Faculty of Science and Technology, Norwegian University of Life Sciences, Ås, Norway.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Moore', 'Affiliation': 'Vector Control Product Testing Unit, Ifakara Health Institute, Bagamoyo, Tanzania.'}]",PLoS medicine,['10.1371/journal.pmed.1003248']
3186,32946500,Impact of the extension of a performance-based financing scheme to nutrition services in Burundi on malnutrition prevention and management among children below five: A cluster-randomized control trial.,"Malnutrition is a huge problem in Burundi. In order to improve the health system response, the Ministry of Health piloted the introduction of malnutrition prevention and care indicators within its performance-based financing (PBF) scheme. Paying for units of services and for qualitative indicators is expected to enhance provision and quality of these nutrition services. The objective of this study is to assess the impacts of this intervention, on both child acute malnutrition recovery rates at health centre level and prevalence of chronic and acute malnutrition among children at community level. This study follows a cluster-randomized controlled evaluation design: 90 health centres (HC) were randomly selected for the study, 45 of them were randomly assigned to the intervention and received payment related to their performance in malnutrition activities, while the other 45 constituted the control group and got a simple budget allocation. Data were collected from baseline and follow-up surveys of the 90 health centres and 6,480 households with children aged 6 to 23 months. From the respectively 1,067 and 1,402 moderate and severe acute malnutrition transcribed files and registers, findings suggest that the intervention had a positive impact on moderate acute malnutrition recovery rates (OR: 5.59, p = 0.039 -at the endline, 78% in the control group and 97% in the intervention group) but not on uncomplicated severe acute malnutrition recovery rate (OR: 1.16, p = 0.751 -at the endline, 93% in the control group and 92% in the intervention group). The intervention also had a significant increasing impact on the number of children treated for acute malnutrition. Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp. 8.80% and 49.90% in the control group and 8.70% and 52.0% in the intervention group, the differences being non-significant. PBF can contribute to a better management of malnutrition at HC level; yet, to address the huge problem of child malnutrition in Burundi, additional strategies are urgently required.",2020,"Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp.","['children below five', '90 health centres (HC', '6,480 households with children aged 6 to 23 months', 'children at community level', '12,679 children aged 6-23 months']","['payment related to their performance in malnutrition activities, while the other 45 constituted the control group and got a simple budget allocation', 'PBF']","['uncomplicated severe acute malnutrition recovery rate', 'moderate acute malnutrition recovery rates', 'number of children treated for acute malnutrition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}]","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]",12679.0,0.0481994,"Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Korachais', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Nkurunziza', 'Affiliation': 'Global Health Institute, University of Antwerp, Belgium.'}, {'ForeName': 'Manassé', 'Initials': 'M', 'LastName': 'Nimpagaritse', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Meessen', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}]",PloS one,['10.1371/journal.pone.0239036']
3187,32946551,Do home modifications reduce care home admissions for older people? A matched control evaluation of the Care & Repair Cymru service in Wales.,"BACKGROUND


home advice and modification interventions aim to promote independent living for those living in the community, but quantitative evidence of their effectiveness is limited.
AIM


assess the risk of care home admissions for people with different frailty levels receiving home advice and modification interventions against a control group who do not.
STUDY DESIGN AND SETTING


matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice. The intervention group received the Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales.
METHODS


frailty, age and gender were used in propensity score matching to assess the Hazard Ratio (HR) of care home admissions within a 1-, 3- and 5-year period for the intervention group (N = 93,863) compared to a matched control group (N = 93,863). Kaplan-Meier curves were used to investigate time to a care home admission.
RESULTS


the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years [HR (95%CI)] for those classified as fit [1-year: 2.02 (1.73, 2.36), 3-years: 1.87 (1.72, 2.04), 5-years: 1.99 (1.86, 2.13)] and mildly frail [1-year: 1.25 (1.09, 1.42), 3-years: 1.25 (1.17, 1.34), 5-years: 1.30 (1.23, 1.38)], but a reduced risk of care home admission for moderately [1-year: 0.66 (0.58, 0.75), 3-years: 0.75 (0.70, 0.80), 5-years: 0.83 (0.78, 0.88)] and severely frail individuals [1-year: 0.44 (0.37, 0.54), 3-years: 0.54 (0.49, 0.60), 5-years: 0.60(0.55, 0.66)].
CONCLUSIONS


HRs indicated that the C & RC service helped to prevent care home admissions for moderately and severely frail individuals. The HRs generally increased with follow-up duration.",2020,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","['people with different frailty levels receiving home advice and modification interventions against a control group who do not', '5-years', 'matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice']","['C & RC service', 'Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales']","['reduced risk of care home admission', 'risk of a care home admission', 'Hazard Ratio (HR) of care home admissions', 'mildly frail', 'HR (95%CI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}]",,0.0910446,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hollinghurst', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fry', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Care & Repair Cymru, Cardiff, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hillcoat-Nallétamby', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ronan A', 'Initials': 'RA', 'LastName': 'Lyons', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clegg', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Rodgers', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}]",Age and ageing,['10.1093/ageing/afaa158']
3188,32946836,"Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial.","BACKGROUND


In the absence of a licensed vaccine, Clostridioides (formerly Clostridium) difficile infection represents a substantial health burden. The aim of this study was to evaluate the efficacy, immunogenicity, and safety of a toxoid vaccine candidate.
METHODS


We did a phase 3 multicentre, observer-blind, randomised, controlled trial at 326 hospitals, clinics, and clinical research centres in 27 countries in the USA, Canada, Latin America, Europe, and the Asia-Pacific region. We included adults aged 50 years or older who were considered to be at an increased risk of C difficile infection because they had previously had two hospital stays (each ≥24 h in duration) and had received systemic antibiotics in the previous 12 months (risk stratum 1), or because they were anticipating being admitted to hospital for 72 h or more for elective surgery within 60 days of enrolment (risk stratum 2). Eligible participants were stratified by geographical region and the two risk strata, and randomly assigned (2:1), with a fixed block size of three, to receive either a C difficile toxoid vaccine candidate, containing toxoids A and B (C difficile vaccine candidate group), or a placebo vaccine (placebo group). Participants, investigators, and personnel responsible for collecting safety data and analysing blood and stool samples were masked to group assignment. Personnel responsible for study product preparation and administration were not masked to group assignment. One dose (0·5 mL) of C difficile vaccine candidate or placebo vaccine was administered intramuscularly on days 0, 7, and 30. The primary outcome was the efficacy of the vaccine in preventing symptomatic C difficile infection, defined as having three or more loose stools in a period of 24 h or less, loose stools for 24 h or more, and a PCR-positive test for C difficile toxin B in a loose stool sample, within 3 years after the final vaccine dose. The primary outcome was measured in the modified intention-to-treat population (ie, all participants who received at least one injection of the assigned vaccine). The safety of the vaccine was assessed in the safety analysis set (ie, all participants who had received at least one injection, analysed according to the product received). This study is registered with WHO/ICTRP, number U111-1127-7162, and ClinicalTrials.gov, number NCT01887912, and has been terminated.
FINDINGS


Between July 30, 2013, and Nov 17, 2017, we enrolled and randomly assigned 9302 participants to the C difficile vaccine candidate group (n=6201) or to the placebo group (n=3101). 6173 (99·5%) participants in the C difficile vaccine candidate group and 3085 (99·5%) participants in the placebo group received at least one dose of the vaccine. The study was terminated after the first planned interim analysis because of futility. In the C difficile vaccine candidate group, 34 C difficile infections were reported over 11 697·2 person-years at risk (0·29 infections per 100 person-years [95% CI 0·20-0·41]) compared with 16 C difficile infections over 5789·4 person-years at risk in the placebo group (0·28 infections per 100 person-years [0·16-0·45]), indicating a vaccine efficacy of -5·2% (95% CI -104·1 to 43·5). In the C difficile vaccine candidate group, 2847 (46·6%) of 6113 participants reported an adverse event within 30 days of injection compared with 1282 (41·9%) of 3057 participants in the placebo group. The proportion of participants who had an adverse event leading to study discontinuation was 4·8% in both groups (296 participants in the C difficile vaccine candidate group and 146 participants in the placebo group). 1662 (27·2%) participants in the C difficile vaccine candidate group reported at least one serious adverse event compared with 851 (27·8%) participants in the placebo group.
INTERPRETATION


In adults at risk for C difficile infection, a bivalent C difficile toxoid vaccine did not prevent C difficile infection. Since the C difficile vaccine candidate met the criteria for futility, the study was terminated and clinical development of this vaccine candidate was stopped.
FUNDING


Sanofi Pasteur.",2020,"In adults at risk for C difficile infection, a bivalent C difficile toxoid vaccine did not prevent C difficile infection.","['Eligible participants were stratified by geographical region and the two risk strata', '6173 (99·5%) participants in the C difficile vaccine candidate group and 3085 (99·5%) participants in the', '326 hospitals, clinics, and clinical research centres in 27 countries in the USA, Canada, Latin America, Europe, and the Asia-Pacific region', 'Between July 30, 2013, and Nov 17, 2017, we enrolled and randomly assigned 9302 participants to the C difficile vaccine candidate group (n=6201) or to the', 'adults aged 50 years or older who were considered to be at an increased risk of C difficile infection because they had previously had two hospital stays (each ≥24 h in duration) and had received systemic antibiotics in the previous 12 months (risk stratum 1), or because they were anticipating being admitted to hospital for 72 h or more for elective surgery within 60 days of enrolment (risk stratum 2', 'participants who had an adverse event leading to study discontinuation was 4·8% in both groups (296 participants in the C difficile vaccine candidate group and 146 participants in the placebo group', 'participants who had received at least one injection, analysed according to the product received']","['Clostridioides difficile toxoid vaccine candidate', 'C difficile toxoid vaccine candidate, containing toxoids A and B (C difficile vaccine candidate group), or a placebo vaccine (placebo', 'C difficile vaccine candidate or placebo vaccine', 'vaccine', 'placebo', 'toxoid vaccine candidate']","['symptomatic C difficile infection, defined as having three or more loose stools in a period of 24 h or less, loose stools', 'modified intention-to-treat population', 'efficacy, immunogenicity, and safety', 'serious adverse event', 'C difficile infection', 'Safety, immunogenicity, and efficacy', 'adverse event']","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0040555', 'cui_str': 'Toxoid'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",9302.0,0.716674,"In adults at risk for C difficile infection, a bivalent C difficile toxoid vaccine did not prevent C difficile infection.","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'de Bruyn', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: guy.debruyn@sanofi.com.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gordon', 'Affiliation': 'Department of Infectious Diseases and Microbiology, SA Pathology, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tambyah', 'Affiliation': 'National University of Singapore and National University Health System, Singapore.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cosgrove', 'Affiliation': ""Vaccine Institute, St George's University, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Martens', 'Affiliation': 'Reading Hospital, West Reading, PA, USA.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Bassily', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Eng-Soon', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': 'Sanofi Pasteur, Toronto, ON, Canada.'}, {'ForeName': 'Dhaval', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Torre-Cisneros', 'Affiliation': 'Hospital Universitario Reina Sofia-IMIBIC, University of Cordoba, Spanish Network for Research in Infectious Disease, Cordoba, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernando De Magalhães Francesconi', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gesser', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeanfreau', 'Affiliation': 'MedPharmics, Metairie, LA, USA.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université Paris Descartes, Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Thelma', 'Initials': 'T', 'LastName': 'Laot', 'Affiliation': 'Sanofi Pasteur, Manila, Philippines.'}, {'ForeName': 'Rayo', 'Initials': 'R', 'LastName': 'Morfin-Otero', 'Affiliation': 'Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Mexico.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Oviedo-Orta', 'Affiliation': 'Sanofi Pasteur, Lyon, France; Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, National Health Insurance Service, Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Franco M', 'Initials': 'FM', 'LastName': 'Piazza', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rehm', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'Sanofi Pasteur, Mexico City, Mexico.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Self', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30331-5']
3189,32946885,Training primary care professionals in multimorbidity management: educational assessment of the eMULTIPAP course.,"Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",2020,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",['general practitioners (GP) and his/her patients with MM with 12 months follow-up'],"['Multimorbidity (MM', 'eMULTIPAP']","['Medication Appropriateness Index', ""GP's learning""]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0184836,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.","[{'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Teaching Unit for Family and community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: francisca.leiva.sspa@juntadeandalucia.es.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': 'Teaching Unit for Family and community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: juand.prados.sspa@juntadeandalucia.es.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'Health Services and Chronic conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: sprados.iacs@aragon.es.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del-Cura-González', 'Affiliation': 'Health Services and Chronic conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit. Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain. Electronic address: isabel.cura@salud.madrid.org.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Castillo-Jimena', 'Affiliation': 'Teaching Unit for Family and community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Coín. Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: marcosc.malaga@gmail.com.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Health Services and Chronic conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit. Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain; Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: juanantonio.lopez@salud.madrid.org.'}, {'ForeName': 'Maria Eloísa', 'Initials': 'ME', 'LastName': 'Rogero-Blanco', 'Affiliation': 'Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: mariaeloisa.rogero@salud.madrid.org.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'López-Verde', 'Affiliation': 'Teaching Unit for Family and community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Primary Care Health Centre Las Delicias. Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: flverde@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Bujalance-Zafra', 'Affiliation': 'Teaching Unit for Family and community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Victoria. Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: mjbujalance@hotmail.com.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Pico-Soler', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre Torrero-La Paz, Aragon Health Service, Zaragoza, Spain. Electronic address: vpico@salud.aragon.es.'}, {'ForeName': 'Luis Andrés', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre San Pablo. Aragon Health Service, Zaragoza, Spain. Electronic address: lugifel@gmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Health Services and Chronic conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: bpoblador.iacs@aragon.es.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Martinez-Cañavate', 'Affiliation': 'IAVANTE: Línea de Formación de la Fundación Progreso y Salud, Junta de Andalucía, Spain. Electronic address: teresa.martinezcanavate@juntadeandalucia.es.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt, Germany. Electronic address: muth@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'MULTIPAP Group: see Acknowledgements.'}]",Mechanisms of ageing and development,['10.1016/j.mad.2020.111354']
3190,32946924,"Sacituzumab Govitecan in Previously Treated Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer: Final Results from a Phase 1/2, Single-Arm, Basket Trial.","BACKGROUND


Trophoblast cell-surface antigen-2 (Trop-2) is expressed in epithelial cancers, including hormone receptor-positive (HR+) metastatic breast cancer (mBC). Sacituzumab govitecan (SG; Trodelvy™) is an antibody-drug conjugate composed of a humanized anti-Trop-2 monoclonal antibody coupled to SN-38 at a high drug:antibody ratio via a unique hydrolyzable linker that delivers SN-38 intracellularly and in the tumor microenvironment. SG was granted accelerated FDA approval for metastatic triple-negative BC treatment in April 2020.
PATIENTS AND METHODS


We analyzed a pre-specified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase 1/2, single-arm trial (NCT01631552), who received intravenous SG (10 mg/kg) and whose disease progressed on endocrine-based therapy and at least one prior chemotherapy for mBC. Endpoints included objective response rate (ORR: RECIST 1.1) assessed locally, duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS


Fifty-four women were enrolled between February 13, 2015 and June 1, 2017. Median (range) age was 54 (33-79) and all received at least two prior lines of therapy for mBC. At data cut-off (March 1, 2019), 12 patients were still alive. Key grade ≥3 treatment-related toxicities included neutropenia (50.0%), anemia (11.1%), and diarrhea (7.4%). Two patients discontinued treatment due to treatment-related adverse events. No treatment-related deaths occurred. At a median follow-up of 11.5 months, the ORR was 31.5% (95% confidence interval [CI], 19.5%-45.6%; 17 partial responses); median DOR was 8.7 months (95% CI, 3.7-12.7), median PFS was 5.5 months (95% CI, 3.6-7.6), and median OS was 12 months (95% CI, 9.0-18.2).
CONCLUSIONS


SG shows encouraging activity in patients with pretreated HR+/HER2- mBC and a predictable, manageable safety profile. Further evaluation in a randomized phase 3 trial (TROPiCS-02) is ongoing (NCT03901339).",2020,No treatment-related deaths occurred.,"['Fifty-four women were enrolled between February 13, 2015 and June 1, 2017', 'We analyzed a pre-specified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase 1/2, single-arm trial (NCT01631552), who received']","['Sacituzumab Govitecan', 'intravenous SG', 'endocrine-based therapy and at least one prior chemotherapy for mBC']","['diarrhea', 'ORR', '17 partial responses); median DOR', 'anemia', 'toxicities included neutropenia', 'median OS', 'median PFS', 'objective response rate (ORR: RECIST 1.1) assessed locally, duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C4086837', 'cui_str': 'sacituzumab govitecan'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",54.0,0.128403,No treatment-related deaths occurred.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kalinsky', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Columbia University Irving Medical Center-Herbert Irving Comprehensive Cancer Center, New York, NY. Electronic address: kk2693@cumc.columbia.edu.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Diamond', 'Affiliation': 'Department of Medicine, Medical Oncology, University of Colorado Cancer Center, Aurora, CO.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Vahdat', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Juric', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Texas Oncology, Baylor University Medical Center, US Oncology, Dallas, TX.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Moroose', 'Affiliation': 'Department of Hematology/Oncology, Orlando Health UF Health Cancer Center, Orlando, FL.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Abramson', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Goldenberg', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Sharkey', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maliakal', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Hong', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goswami', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Wegener', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, NJ.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.09.004']
3191,32946978,Sensory attributes of coated tablets: developing a formal lexicon and sensory wheel.,"The patient's sensory experience when taking an oral medicine is important in the assessment of its palatability, and acceptability. The aim of this study was to develop tools useful for standardisation of sensory assessment of coated tablets: a lexicon and a sensory wheel. Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets. By adapting the principles used by food sciences, a free-text description of conventional, bitter-tasting or tasteless, coated tablets was performed. In the first assessment, volunteers described the sensory attributes of the first set of tablets. The attributes collected were then validated using a second set of tablets in a separate study with different volunteers. The appropriateness and semantics of each sensory attribute was analysed. Twenty attributes most relevant for assessment of coated tablets were selected for the lexicon and associated with explicit definitions. A collection of all attributes that could possibly be triggered by coated tablets were organised in the form of a sensory wheel. This study provides a valuable insight into the sensory experience while taking a coated tablet and presents tools which can accelerate the development of palatable medicines.",2020,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.",['52 heathy adult volunteers and two sets of coated tablets'],['coated tablets'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}]",[],,0.0459016,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: hannah.batchelor@strath.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119883']
3192,32947028,"Efficacy of aminolevulinic acid 20% solution combined with photodynamic therapy in the treatment of actinic keratoses on the upper extremities: A post hoc analysis of a phase 3, randomized, vehicle-controlled trial.","BACKGROUND


Photodynamic therapy with 5-aminolevulinic acid is indicated for targeted treatment of actinic keratoses on the face, scalp, and upper extremities. This was a post hoc analysis of a phase 3 randomized trial assessing the efficacy of aminolevulinic acid/photodynamic therapy for treatment of actinic keratoses on the upper extremities.
METHODS


Adults with 4-15 grade 1-2 actinic keratosis lesions on ≥1 upper extremity were randomized (1:1) to receive aminolevulinic acid/photodynamic therapy or vehicle/photodynamic therapy applied to individual lesions followed by occlusion and blue light treatment. Assessments included the clearance rate of treated lesions vs baseline, cumulative disease area clearance, and complete clearance by lesion size.
RESULTS


There were 135 and 134 patients randomized to aminolevulinic acid/photodynamic therapy and vehicle/photodynamic therapy groups, respectively. At 12 weeks, clearance of treated lesions (80.6% vs 45.5%;P <0.0001) and the mean decrease in cumulative disease area (82.4% vs 42.6%; P <0.0001) was significantly higher for aminolevulinic acid/photodynamic therapy vs vehicle/photodynamic therapy, respectively. Rates of complete clearance and clearance by cutpoint (≥90%, ≥85%, ≥80%, or ≥75% clearance) were numerically higher for aminolevulinic acid/photodynamic therapy. Clearance of lesions was higher for aminolevulinic acid/photodynamic therapy vs vehicle/photodynamic therapy regardless of baseline lesion size. Aminolevulinic acid/photodynamic therapy was well tolerated with adverse events consistent with those expected with photodynamic therapy.
CONCLUSIONS


Aminolevulinic acid/photodynamic therapy is effective and well tolerated for the treatment of actinic keratosis lesions of the extremities.",2020,Clearance of lesions was higher for aminolevulinic acid/photodynamic therapy vs vehicle/photodynamic therapy regardless of baseline lesion size.,"['Adults with 4-15 grade 1-2 actinic keratosis lesions on ≥1 upper extremity', 'actinic keratoses on the upper extremities']","['aminolevulinic acid/photodynamic therapy and vehicle/photodynamic therapy', '5-aminolevulinic acid', 'aminolevulinic acid/photodynamic therapy or vehicle/photodynamic therapy applied to individual lesions followed by occlusion and blue light treatment', 'Aminolevulinic acid/photodynamic therapy', 'aminolevulinic acid/photodynamic therapy vs vehicle/photodynamic therapy', 'aminolevulinic acid/photodynamic therapy', 'aminolevulinic acid 20% solution combined with photodynamic therapy']","['clearance rate of treated lesions vs baseline, cumulative disease area clearance, and complete clearance by lesion size', 'Rates of complete clearance and clearance', 'cumulative disease area', 'clearance of treated lesions', 'Clearance of lesions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}]","[{'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}]",,0.0843171,Clearance of lesions was higher for aminolevulinic acid/photodynamic therapy vs vehicle/photodynamic therapy regardless of baseline lesion size.,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Berman', 'Affiliation': 'Center for Clinical and Cosmetic Research, 2925 Aventura Blvd, Suite 205, Aventura, FL, 33180, USA; Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, 1295 N.W. 14th St., Suite K-M, Miami, FL, 33136, USA. Electronic address: bbmdphd@gmail.com.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Therapeutics Clinical Research, 9025 Balboa Avenue, Suite 105, San Diego, CA, 92123, USA. Electronic address: nbhatia@therapeuticsresearch.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Piacquadio', 'Affiliation': 'Therapeutics, Inc., 9025 Balboa Ave, Suite 100, San Diego, CA, 92123, USA. Electronic address: Danp@therapeuticsinc.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Houlihan', 'Affiliation': 'DUSA Pharmaceuticals, Inc., 25 Upton Drive, Wilmington, MA, 01887, USA. Electronic address: houlihana@optonline.net.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Davidson', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ, 08540, USA. Electronic address: David.Davidson@sunpharma.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Siegel', 'Affiliation': 'Department of Dermatology, The State University of New York Downstate Health Sciences University, 450 Clarkson Avenue, Brooklyn, NY, 11203, USA; Dermatology Service, Veterans Affairs New York Harbor Healthcare System, 800 Poly Place, Brooklyn, NY, 11209, USA. Electronic address: cyberderm@dermsurg.org.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102013']
3193,32947389,Effect of intraoperative mitomycin-C application on epithelial regeneration after transepithelial photorefractive keratectomy.,"PURPOSE


To investigate the effect of mitomycin-C (MMC) intraoperative application on postoperative corneal epithelial remodeling, haze incidence and refractive correction in transepithelial photorefractive keratectomy (transPRK).
SETTING


Eye Hospital of Wenzhou Medical University, Wenzhou, China.
DESIGN


Prospective randomized controlled study.
METHODS


Eyes that completed all follow-up were included. Epithelial thickness (ET) map measurement was conducted preoperatively and at week 1, and 1, 3, and 6 months postoperatively, generating ET in central, paracentral, and midperipheral zones. The difference between postoperative and preoperative ET (ΔET) was computed for each zone. During follow-up, haze incidence and visual acuity were assessed and compared between groups.
RESULTS


A total of 100 eyes completed all follow-up, including 40 eyes treated with MMC in MMC group, 60 eyes without treated with MMC in control group. For ΔET, between-group difference was found in midperipheral (P = 0.011) zone at week 1 postoperatively and in central (P = 0.036) and paracentral zones (P = 0.039) at 1 month postoperatively. Haze incidence was lower in MMC group at week 1 and month 1 postoperatively (P = 0.035 and 0.018, respectively). Safety index (postoperative uncorrected distance visual acuity/preoperative corrected distance visual acuity [CDVA]) and efficacy index (postoperative CDVA/preoperative CDVA) were higher in MMC group (P = 0.012 and P = 0.036, respectively) at month 1 postoperatively. No difference was found after month 3 postoperatively.
CONCLUSIONS


With a temporary impact on corneal epithelial regeneration and refractive correction, intraoperative MMC application in transPRK decreased the haze incidence but had no effect on epithelial remodeling.",2020,"Haze incidence was lower in MMC group at week 1 and month 1 postoperatively (P = 0.035 and 0.018, respectively).","['Eye Hospital of Wenzhou Medical University, Wenzhou, China', 'transepithelial photorefractive keratectomy (transPRK', 'epithelial regeneration after transepithelial photorefractive keratectomy', 'A total of 100 eyes completed all follow-up, including 40 eyes treated with MMC in MMC group, 60 eyes without treated with', 'Eyes that completed all follow-up were included']","['mitomycin-C (MMC) intraoperative application', 'MMC', 'intraoperative mitomycin-C application']","['Haze incidence', 'epithelial remodeling', 'haze incidence and visual acuity', 'midperipheral', 'Safety index (postoperative uncorrected distance visual acuity/preoperative corrected distance visual acuity [CDVA]) and efficacy index (postoperative CDVA/preoperative CDVA', 'corneal epithelial regeneration', 'postoperative and preoperative ET (ΔET']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",100.0,0.0900215,"Haze incidence was lower in MMC group at week 1 and month 1 postoperatively (P = 0.035 and 0.018, respectively).","[{'ForeName': 'Nan-Ji', 'Initials': 'NJ', 'LastName': 'Lu', 'Affiliation': 'From the School of Medicine and Health Sciences, University of Antwerp (Lu, Koppen), Wilrijk, Belgium; School of Ophthalmology and Optometry, Wenzhou Medical University (Lu, I. Aslanides, Chen), Wenzhou, Zhejiang, China; Emmetropia Mediterranean Eye Institute (M. Aslanides, I. Aslanides) Heraklion, Greece; The American University of Beirut Medical Center, Cairo Street (Awwad), Beirut, Lebanon. Supported by Chinese Scholarship Council (NO. 202008330323).'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Koppen', 'Affiliation': ''}, {'ForeName': 'Shady', 'Initials': 'S', 'LastName': 'Awwad', 'Affiliation': ''}, {'ForeName': 'Minas', 'Initials': 'M', 'LastName': 'Aslanides', 'Affiliation': ''}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Aslanides', 'Affiliation': ''}, {'ForeName': 'Shi-Hao', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000427']
3194,32947390,"Potential hypotensive effects of Umezu polyphenols: a 14-week community-based, double-masked and placebo-controlled trial.","OBJECTIVE


To evaluate blood pressure (BP)-lowering effects of Umezu polyphenols, polyphenols contained in Japanese plums, in a community-based sample by double-masked and placebo-controlled design.
METHODS


Seventy-two Japanese community-dwellers who were interested in prevention or control of their BP (preferably high-normal BP or grade I hypertension) but without antihypertensive medication were randomized into Umezu polyphenols or placebo groups. Each subject took 800 mg/day of Umezu polyphenols or placebo for 12 weeks, followed by a 2-week washout period. Their home and office BP were monitored for 14 weeks in a double-masked manner. We analyzed 56 subjects who met the inclusion criteria.
RESULTS


Home BP increased gradually in both the groups during the intervention period, while diastolic office BP insignificantly decreased in the intervention group. During the washout period, home systolic BP in the morning elevated only in the intervention group.
CONCLUSIONS


The study failed to collect consistent evidence of a clear persistent hypotensive effect of Umezu polyphenols.",2020,"Home BP increased gradually in both the groups during the intervention period, while diastolic office BP insignificantly decreased in the intervention group.","['Seventy-two Japanese community-dwellers who were interested in prevention or control of their BP (preferably high-normal BP or grade', '56 subjects who met the inclusion criteria']","['Umezu polyphenols', 'Umezu polyphenols, polyphenols', 'Umezu polyphenols or placebo']","['diastolic office BP', 'Home BP', 'blood pressure', 'home systolic BP']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",72.0,0.323,"Home BP increased gradually in both the groups during the intervention period, while diastolic office BP insignificantly decreased in the intervention group.","[{'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Takemura', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Yoshimasu', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Kanami', 'Initials': 'K', 'LastName': 'Tsuno', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Kishida', 'Affiliation': 'Department of Science and Technology on Food Safety, Faculty of Biology-Oriented Science and Technology, Kindai University, Kinokawa.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Mitani', 'Affiliation': 'Research Center for Food and Agriculture, Center for Regional Revitalization, Wakayama University, Wakayama, Wakayama, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Miyashita', 'Affiliation': 'Department of Hygiene, School of Medicine, Wakayama Medical University, Wakayama.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000476']
3195,32947424,"Does Pregnenolone Adjunct to Risperidone Ameliorate Irritable Behavior in Adolescents With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial?","OBJECTIVES


Pregnenolone is a neurosteroid with modulatory effects on γ-aminobutyric acid neurotransmission. Here, we aimed to evaluate the effectiveness and safety of pregnenolone add-on to risperidone in adolescents with autism spectrum disorders (ASD).
METHODS


Sixty-four ASD patients were randomly allocated to receive either pregnenolone (n = 32) or matching placebo (n = 32) in addition to risperidone. The Aberrant Behavior Checklist-Community Edition scale was used to evaluate the behavioral status of patients at baseline, week 5, and the trial end point. The change in score of irritability subscale was the primary outcome. Frequency of adverse effects due to trial medications was compared between the treatment groups.
RESULTS


Fifty-nine patients completed the trial (30 in pregnenolone and 29 in the placebo arm). Baseline characteristics of both treatment groups were similar (P > 0.05). Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively). Nonetheless, the alterations in lethargy and inappropriate speech domains scores were similar for both arms (F = 0.93, df = 1.49, P = 0.375; F = 1.10, df = 1.60, P = 0.325, respectively). There was no significant difference in frequency as well as severity of adverse effects between the 2 groups.
CONCLUSIONS


Pregnenolone adjunct to risperidone could attenuate core features associated with ASD.",2020,"Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively).","['Adolescents With Autism', 'adolescents with autism spectrum disorders (ASD', 'Fifty-nine patients completed the trial (30 in pregnenolone and 29 in the placebo arm', 'Sixty-four ASD patients', 'Spectrum Disorder']","['Pregnenolone', 'Risperidone', 'risperidone', 'matching placebo', 'pregnenolone', 'Placebo']","['Aberrant Behavior Checklist-Community Edition scale', 'effectiveness and safety', 'irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition', 'lethargy and inappropriate speech domains scores', 'score of irritability subscale', 'severity of adverse effects']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033016', 'cui_str': 'Pregnenolone measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0033016', 'cui_str': 'Pregnenolone measurement'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C1168248', 'cui_str': 'Inappropriate speech'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",64.0,0.524653,"Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively).","[{'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Ayatollahi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sayna', 'Initials': 'S', 'LastName': 'Bagheri', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ashraf-Ganjouei', 'Affiliation': ''}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': ''}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': ''}]",Clinical neuropharmacology,['10.1097/WNF.0000000000000405']
3196,32947423,Nalbuphine Exhibited a Better Adjuvant Than Dexmedetomidine in Supraclavicular Brachial Plexus Block in Youths.,"OBJECTIVE


Nalbuphine and dexmedetomidine are both used as anesthesia adjuvants for brachial plexus block, but their efficacy and safety in younger patients are not clear. In this study, we aimed to compare the efficacy and side effects of these 2 drugs in young patients undergoing brachial plexus block.
METHODS


We recruited 48 young patients aged 18 to 30 years requiring supraclavicular brachial plexus block. Subjects were randomly divided into 2 groups. Patients in group levobupivacaine+nalbuphine received 28 mL of 0.5% levobupivacaine and 10 mg of nalbuphine diluted in 2 mL 0.9% saline. Patients in group levobupivacaine+dexmedetomidine (LD) received 28 mL of 0.5% levobupivacaine and 0.75 μg/kg dexmedetomidine diluted in 2 mL 0.9% saline. Demographic information, types of fracture, onset time of motor and sensory blocks, duration of block, side effects, and analgesic use were recorded.
RESULTS


We found that the 2 groups did not differ significantly in the demographic profile and fracture type. Compared with group LD, group LD had significantly shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects.
CONCLUSION


In summary, our study suggests that nalbuphine is a better anesthesia adjuvant for supraclavicular brachial plexus block in young patients.",2020,"Compared with group LD, group LD had significantly shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects.
","['younger patients', '48 young patients aged 18 to 30 years requiring supraclavicular brachial plexus block', 'Youths', 'young patients', 'young patients undergoing brachial plexus block']","['levobupivacaine+dexmedetomidine (LD) received 28 mL of 0.5% levobupivacaine', 'dexmedetomidine diluted in 2 mL 0.9% saline', 'nalbuphine', 'Nalbuphine and dexmedetomidine', 'Dexmedetomidine', 'levobupivacaine', 'nalbuphine diluted in 2 mL 0.9% saline', 'Nalbuphine']","['efficacy and side effects', 'demographic profile and fracture type', 'shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects', 'Demographic information, types of fracture, onset time of motor and sensory blocks, duration of block, side effects, and analgesic use']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}]","[{'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",48.0,0.107087,"Compared with group LD, group LD had significantly shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects.
","[{'ForeName': 'Changcheng', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}, {'ForeName': 'Wenji', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Quanzhou Hospital of Traditional Chinese Medicine, Quanzhou.'}, {'ForeName': 'Wenqin', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}, {'ForeName': 'Zhenming', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University of China, Quanzhou, Fujian, China.'}, {'ForeName': 'Naizhen', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}]",Clinical neuropharmacology,['10.1097/WNF.0000000000000410']
3197,32947445,Improved prognosis of infection with M. genavense in immune compromized HIV patients after introduction of combined antiretroviral therapy.,,2020,,[],[],[],[],[],[],,0.0451888,,"[{'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Ahrenstorf', 'Affiliation': 'Clinic for Immunology and Rheumatology, Hannover Medical School (MHH), Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jablonka', 'Affiliation': 'Clinic for Immunology and Rheumatology, Hannover Medical School (MHH), Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ernst', 'Affiliation': 'Clinic for Immunology and Rheumatology, Hannover Medical School (MHH), Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Franz-Christoph', 'Initials': 'FC', 'LastName': 'Bange', 'Affiliation': 'Institute for Microbiology, Hannover Medical School (MHH), Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Heiken', 'Affiliation': 'Private practice Georgstrasse, Georgstrasse 46, 30 159 Hannover.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Witte', 'Affiliation': 'Clinic for Immunology and Rheumatology, Hannover Medical School (MHH), Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Reinhold E', 'Initials': 'RE', 'LastName': 'Schmidt', 'Affiliation': 'Clinic for Immunology and Rheumatology, Hannover Medical School (MHH), Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stoll', 'Affiliation': 'Clinic for Immunology and Rheumatology, Hannover Medical School (MHH), Carl-Neuberg-Str. 1, 30625 Hannover, Germany.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002513']
3198,32946806,Failure to Improve Verbal Fluency with Transcranial Direct Current Stimulation.,"Previous studies in healthy populations have provided equivocal evidence whether the application of anodal transcranial direct current stimulation (tDCS) over the left prefrontal cortex (PFC) can improve performance in verbal fluency tasks. In this double-blind, randomised within-participant study, we investigated whether anodal tDCS over the left PFC improves verbal fluency performance relative to sham tDCS. Forty eight healthy native German speakers performed two verbal fluency tasks after having received 20 min of anodal or sham tDCS over the left PFC. During stimulation, participants performed a picture naming task, which was expected to increase neuronal activity in the targeted region. We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions. Furthermore, initiation time (i.e., time to produce the first correct utterance) was not affected by tDCS. As an unexpected finding, picture naming latencies were significantly longer during anodal compared to sham tDCS. Yet, changes in the naming task were not predictive of performance changes in the fluency task. Overall, the current study found no evidence that verbal fluency performance in healthy speakers could be improved by excitatory stimulation of the left PFC. We argue that previously observed positive effects could be false positives and should be interpreted with caution. The findings from the current study thus cast further doubt on the utility of tDCS in enhancing cognitive performance in the healthy (young) brain.",2020,"We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions.","['healthy speakers', 'Forty eight healthy native German speakers', 'healthy (young) brain', 'healthy populations']","['verbal fluency tasks after having received 20\u202fmin of anodal or sham tDCS', 'anodal transcranial direct current stimulation (tDCS', 'anodal tDCS', 'tDCS']","['cognitive performance', 'Verbal Fluency', 'verbal fluency tasks', 'picture naming latencies', 'neuronal activity', 'verbal fluency performance', 'Furthermore, initiation time (i.e., time to produce the first correct utterance']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",48.0,0.0992325,"We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Klaus', 'Affiliation': 'Lise Meitner Research Group Cognition and Plasticity, Max Planck Institute for Human Cognitive and Brain Sciences, Stephanstrasse 1A, 04103 Leipzig, Germany. Electronic address: janaklaus.research@gmail.com.'}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Hartwigsen', 'Affiliation': 'Lise Meitner Research Group Cognition and Plasticity, Max Planck Institute for Human Cognitive and Brain Sciences, Stephanstrasse 1A, 04103 Leipzig, Germany.'}]",Neuroscience,['10.1016/j.neuroscience.2020.09.003']
3199,32946821,Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials.,"BACKGROUND


The DEPICT-1 and DEPICT-2 studies showed that dapagliflozin as an adjunct to insulin in individuals with inadequately controlled type 1 diabetes improved glycaemic control and bodyweight, without increase in risk of hypoglycaemia. We aimed to determine the effect of dapagliflozin on urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) using pooled data from the DEPICT studies.
METHODS


In this post-hoc analysis, we used data pooled from both DEPICT studies (DEPICT-1 ran from Nov 11, 2014, to Aug 25, 2017; DEPICT-2 ran from July 8, 2015, to April 18, 2018), in which participants were aged 18-75 years, with inadequately controlled type 1 diabetes and with a baseline UACR of at least 30 mg/g. In the DEPICT studies, participants were randomly assigned (1:1:1) to receive dapagliflozin (5 mg or 10 mg) or placebo all plus insulin, for 24 weeks, with a 28-week long-term extension (ie, 52 weeks in total). In this post-hoc analysis, we assessed the percentage change from baseline in UACR and in eGFR, up to 52 weeks. UACR, eGFR, and safety were assessed in all eligible participants who had received at least one dose of study drug. HbA 1c , bodyweight, and systolic blood pressure were assessed in all participants who received at least one dose of study drug during the first 24-week period, and who had a baseline and any post-baseline assessment for that parameter. The DEPICT trials were registered with ClinicalTrials.gov, NCT02268214 (DEPICT-1), NCT02460978 (DEPICT-2), and are now complete.
RESULTS


251 participants with albuminuria at baseline were included in this post-hoc analysis; of whom 80 (32%) had been randomly assigned to dapagliflozin 5 mg, 84 (33%) to dapagliflozin 10 mg, and 87 (35%) to placebo. Compared with placebo, treatment with both dapagliflozin doses improved UACR over 52 weeks. At week 52, mean difference in change from baseline versus placebo in UACR was -13·3% (95% CI -37·2 to 19·8) for dapagliflozin 5 mg and -31·1% (-49·9 to -5·2) for dapagliflozin 10 mg. No notable change from baseline was seen in eGFR, with a mean difference in change from baseline versus placebo of 3·27 mL/min per 1·73 m 2  (95% CI -0·92 to 7·45) for dapagliflozin 5 mg and 2·12 mL/min per 1·73 m 2  (-2·03 to 6·27) for dapagliflozin 10 mg. Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
INTERPRETATION


Treatment with dapagliflozin resulted in UACR reduction, which might provide renoprotective benefits in individuals with type 1 diabetes and albuminuria. Dedicated prospective studies are needed to confirm these findings as prespecified endpoints.
FUNDING


AstraZeneca.",2020,"Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
","['individuals with inadequately controlled type 1 diabetes', 'eligible participants who had received at least one dose of study drug', '251 participants with albuminuria at baseline were included in this post-hoc analysis; of whom 80 (32', 'individuals with type 1 diabetes and albuminuria', 'participants were aged 18-75 years, with inadequately controlled type 1 diabetes and with a baseline UACR of at least 30 mg/g', 'individuals with type 1 diabetes']","['placebo', 'placebo all plus insulin', 'dapagliflozin']","['urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR', 'HbA 1c , bodyweight, and systolic blood pressure', 'UACR', 'UACR reduction', 'hypoglycaemia and diabetic ketoacidosis; no new safety signals', 'adverse events and serious adverse events', 'UACR, eGFR, and safety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",251.0,0.625792,"Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
","[{'ForeName': 'Per-Henrik', 'Initials': 'PH', 'LastName': 'Groop', 'Affiliation': 'Abdominal Center, Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland; Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland; Department of Diabetes, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Jacob School of Medicine, State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Edelman', 'Affiliation': 'Department of Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Jendle', 'Affiliation': 'Institute of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'BioParmaceuticals Medical, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thoren', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Repetto', 'Affiliation': 'Global Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium. Electronic address: chantal.mathieu@uzleuven.be.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30280-1']
3200,32946820,"Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial.","BACKGROUND


Although metformin is increasingly being used in women with type 2 diabetes during pregnancy, little data exist on the benefits and harms of metformin use on pregnancy outcomes in these women. We aimed to investigate the effects of the addition of metformin to a standard regimen of insulin on neonatal morbidity and mortality in pregnant women with type 2 diabetes.
METHODS


In this prospective, multicentre, international, randomised, parallel, double-masked, placebo-controlled trial, women with type 2 diabetes during pregnancy were randomly assigned from 25 centres in Canada and four in Australia to receive either metformin 1000 mg twice daily or placebo, added to insulin. Randomisation was done via a web-based computerised randomisation service and stratified by centre and pre-pregnancy BMI (<30 kg/m 2  or ≥30 kg/m 2 ) in a ratio of 1:1 using random block sizes of 4 and 6. Women were eligible if they had type 2 diabetes, were on insulin, had a singleton viable pregnancy, and were between 6 and 22 weeks plus 6 days' gestation. Participants were asked to check their fasting blood glucose level before the first meal of the day, before the last meal of the day, and 2 h after each meal. Insulin doses were adjusted aiming for identical glucose targets (fasting glucose <5·3 mmol/L [95 mg/dL], 2-h postprandial glucose <6·7 mmol/L [120 mg/dL]). Study visits were done monthly and patients were seen every 1-4 weeks as was needed for standard clinical care. At study visits blood pressure and bodyweight were measured; patients were asked about tolerance to their pills, any hospitalisations, insulin doses, and severe hypoglycaemia events; and glucometer readings were downloaded to the central coordinating centre. Participants, caregivers, and outcome assessors were masked to the intervention. The primary outcome was a composite of fetal and neonatal outcomes, for which we calculated the relative risk and 95% CI between groups, stratifying by site and BMI using a log-binomial regression model with an intention-to-treat analysis. Secondary outcomes included several relevant maternal and neonatal outcomes. The trial was registered with ClinicalTrials.gov, NCT01353391.
FINDINGS


Between May 25, 2011, and Oct 11, 2018, we randomly assigned 502 women, 253 (50%) to metformin and 249 (50%) to placebo. Complete data were available for 233 (92%) participants in the metformin group and 240 (96%) in the placebo group for the primary outcome. We found no significant difference in the primary composite neonatal outcome between the two groups (40% vs 40%; p=0·86; relative risk [RR] 1·02 [0·83 to 1·26]). Compared with women in the placebo group, metformin-treated women achieved better glycaemic control (HbA 1c  at 34 weeks' gestation 41·0 mmol/mol [SD 8·5] vs 43·2 mmol/mol [-10]; 5·90% vs 6·10%; p=0·015; mean glucose 6·05 [0·93] vs 6·27 [0·90]; difference -0·2 [-0·4 to 0·0]), required less insulin (1·1 units per kg per day vs 1·5 units per kg per day; difference -0·4 [95% CI -0·5 to -0·2]; p<0·0001), gained less weight (7·2 kg vs 9·0 kg; difference -1·8 [-2·7 to -0·9]; p<0·0001) and had fewer caesarean births (125 [53%] of 234 in the metformin group vs 148 [63%] of 236 in the placebo group; relative risk [RR] 0·85 [95% CI 0·73 to 0·99]; p=0·031). We found no significant difference between the groups in hypertensive disorders (55 [23%] in the metformin group vs 56 [23%] in the placebo group; p=0·93; RR 0·99 [0·72 to 1·35]). Compared with those in the placebo group, metformin-exposed infants weighed less (mean birthweight 3156 g [SD 742] vs 3375 g [742]; difference -218 [-353 to -82]; p=0·002), fewer were above the 97th centile for birthweight (20 [9%] in the metformin group vs 34 [15%] in the placebo group; RR 0·58 [0·34 to 0·97]; p=0·041), fewer weighed 4000 g or more at birth (28 [12%] in the metformin group vs 44 [19%] in the placebo group; RR 0·65 [0·43 to 0·99]; p=0·046), and metformin-exposed infants had reduced adiposity measures (mean sum of skinfolds 16·0 mm [SD 5·0] vs 17·4 [6·2] mm; difference -1·41 [-2·6 to -0·2]; p=0·024; mean neonatal fat mass 13·2 [SD 6·2] vs 14·6 [5·0]; p=0·017). 30 (13%) infants in the metformin group and 15 (7%) in the placebo group were small for gestational age (RR 1·96 [1·10 to 3·64]; p=0·026). We found no significant difference in the cord c-peptide between groups (673 pmol/L [435] in the metformin group vs 758 pmol/L [595] in the placebo group; p=0·10; ratio of means 0·88 [0·72 to 1·02]). The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
INTERPRETATION


We found several maternal glycaemic and neonatal adiposity benefits in the metformin group. Along with reduced maternal weight gain and insulin dosage and improved glycaemic control, the lower adiposity and infant size measurements resulted in fewer large infants but a higher proportion of small-for-gestational-age infants. Understanding the implications of these effects on infants will be important to properly advise patients who are contemplating the use of metformin during pregnancy.
FUNDING


Canadian Institutes of Health Research, Lunenfeld-Tanenbaum Research Institute, University of Toronto.",2020,"The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
","['0·85', 'women with type 2 diabetes during pregnancy', 'pregnant women with type 2 diabetes', 'group; RR 0·58', 'women with type 2 diabetes in pregnancy (MiTy', '0·34 to 0·97', 'women with type 2 diabetes during pregnancy were randomly assigned from 25 centres in Canada and four in Australia to receive either', 'group were small for gestational age (RR 1·96', ""Women were eligible if they had type 2 diabetes, were on insulin, had a singleton viable pregnancy, and were between 6 and 22 weeks plus 6 days' gestation""]","['insulin', 'metformin', 'placebo', 'metformin 1000 mg twice daily or placebo, added to insulin', 'Metformin']","['relative risk [RR', 'maternal weight gain and insulin dosage and improved glycaemic control, the lower adiposity and infant size measurements', 'composite of fetal and neonatal outcomes', 'adiposity measures', 'hypertensive disorders', 'neonatal morbidity and mortality', 'several relevant maternal and neonatal outcomes', 'fasting blood glucose level', 'several maternal glycaemic and neonatal adiposity benefits', 'mean neonatal fat mass 13·2', 'caesarean births', 'glycaemic control', '2-h postprandial glucose']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",502.0,0.606777,"The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
","[{'ForeName': 'Denice S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada. Electronic address: d.feig@utoronto.ca.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Donovan', 'Affiliation': ""Cumming School of Medicine, Department of Medicine, Department of Obstetrics and Gynecology, University of Calgary, Calgary, AB, Canada; Alberta Children's Hospital Research Institute, Calgary, AB, Canada.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sanchez', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Asztalos', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Edmond A', 'Initials': 'EA', 'LastName': 'Ryan', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Fantus', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Hutton', 'Affiliation': 'McMaster University Hamilton, ON, Canada.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'Armson', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lorraine L', 'Initials': 'LL', 'LastName': 'Lipscombe', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, ON, Canada; Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Jon F R', 'Initials': 'JFR', 'LastName': 'Barrett', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Karanicolas', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Tobin', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'H David', 'Initials': 'HD', 'LastName': 'McIntyre', 'Affiliation': 'Mater Research, University of Queensland, South Brisbane, QLD, Australia.'}, {'ForeName': 'Simon Yu', 'Initials': 'SY', 'LastName': 'Tian', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, University Health, Network, Toronto, ON, Canada.'}, {'ForeName': 'Kellie E', 'Initials': 'KE', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada; Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30310-7']
3201,32947299,Comparison of the Safety and Efficacy of Foam Sclerotherapy With 1: 2 Polidocanol to Air Ratio Versus 1: 4 Ratio for the Treatment of Reticular Veins of the Lower Extremities.,"BACKGROUND


Foam sclerotherapy is a common treatment of lower extremity reticular veins. The effect of different liquid-gas ratios on foam stability and efficacy has been controversial.
OBJECTIVE


To evaluate the use of 2 different polidocanol (POL) to air ratios for the treatment of reticular veins of the lower extremities.
METHODS AND MATERIALS


Patients with lower extremity reticular veins were randomized to foam sclerotherapy with POL mixed with 4 mL of room air for one lower extremity or 2 mL for the other lower extremity. All telangiectasias were treated with glycerin immediately after treatment of the reticular veins. Adverse events (AEs) and efficacy were evaluated by both subject and blinded investigator.
RESULTS


Thirty subjects completed the study. No statistically significant difference was seen in AEs between the 2 different POL to air ratios by subject questionnaire and blinded investigator scores at all time points. Subjects and blinded investigator reported a mean improvement between 0% and 50% at Day 21 and 26% to 75% at Day 90, which was not significantly different between groups.
CONCLUSION


Two different POL to air ratios, 1:2 versus 1:4, were similarly safe and efficacious for the treatment reticular veins of the lower extremities.",2020,No statistically significant difference was seen in AEs between the 2 different POL to air ratios by subject questionnaire and blinded investigator scores at all time points.,"['Thirty subjects completed the study', 'reticular veins of the lower extremities', 'Reticular Veins of the Lower Extremities', 'Patients with lower extremity reticular veins']","['foam sclerotherapy with POL mixed with 4 mL of room air for one lower extremity or 2 mL for the other lower extremity', 'polidocanol (POL', 'Polidocanol', 'glycerin', 'Foam Sclerotherapy']","['Safety and Efficacy', 'POL to air ratios by subject questionnaire and blinded investigator scores', 'Adverse events (AEs) and efficacy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439739', 'cui_str': 'Reticular'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0556732,No statistically significant difference was seen in AEs between the 2 different POL to air ratios by subject questionnaire and blinded investigator scores at all time points.,"[{'ForeName': 'Elika', 'Initials': 'E', 'LastName': 'Hoss', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Kollipara', 'Affiliation': 'Westlake Dermatology & Cosmetic Surgery, Dallas, Texas.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Boen', 'Affiliation': 'Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, California.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Alhaddad', 'Affiliation': 'Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, California.'}, {'ForeName': 'Mitchel P', 'Initials': 'MP', 'LastName': 'Goldman', 'Affiliation': 'Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002709']
3202,32947342,Comparative Study on the Efficacy of Frozen Amniotic Membrane Transplantation and Lamellar Keratoplasty in the Treatment of Mooren Ulcer.,"OBJECTIVE


To compare of the clinical efficacy of frozen amniotic membrane transplantation (AMT) and lamellar keratoplasty (LKP) in the treatment of Mooren ulcer.
METHOD


Forty patients (42 eyes) with Mooren's ulcer in our hospital from January 2010 to January 2019 were divided into frozen AMT group (20 eyes) and LKP group (22 eyes). Comparative observation of post-operative best corrected visual acuity (BCVA), corneal epithelial healing time, corneal epithelialization time, ulcer healing, corneal transparency, corneal graft transparency, neovascularization and original disease recurrence were observed.
RESULTS


The average BCVA at post-operative 6 and 12 months in LKP group were significantly lower than AMT group (P < 0.05). The ulcer healing rates in LKP group (63.6) were significantly higher than AMT group (30) (P < 0.05). The corneal epithelialization time of LKP group were 9.55 ± 1.26 days. The corneal epithelial healing time of AMT group were 13.50 ± 2.21 days. Nine cases were corneal graft transparency grade 0, and 13 cases were grade I. Three eyes in AMT group were corneal transparency grade 0, 7 were grade I and 10 were grade II. Corneal neovascularization were observed in 3 eyes in AMT group and 4 eyes in LKP group. The original disease recurrence rates in LKP group (50) were significantly higher than AMT group (20) (P < 0.05). Four cases of primary corneal transplantation failure were observed in LKP group.
CONCLUSION


Lamellar keratoplasty group obtained significantly better BCVA during follow-up and faster healing time than the frozen AMT group while frozen AMT group had lower original disease recurrence rates than LKP group.",2020,The ulcer healing rates in LKP group (63.6) were significantly higher than AMT group (30) (P < 0.05).,"['Mooren ulcer', ""Forty patients (42 eyes) with Mooren's ulcer in our hospital from January 2010 to January 2019"", 'Mooren Ulcer']","['frozen AMT', 'LKP', 'AMT', 'frozen amniotic membrane transplantation (AMT) and lamellar keratoplasty (LKP', 'Frozen Amniotic Membrane Transplantation and Lamellar Keratoplasty']","['corneal epithelial healing time', 'visual acuity (BCVA), corneal epithelial healing time, corneal epithelialization time, ulcer healing, corneal transparency, corneal graft transparency, neovascularization and original disease recurrence', 'healing time', 'ulcer healing rates', 'corneal transplantation failure', 'BCVA', 'Corneal neovascularization', 'average BCVA', 'corneal graft transparency grade', 'original disease recurrence rates', 'corneal epithelialization time']","[{'cui': 'C0155072', 'cui_str': ""Mooren's ulcer""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0022591', 'cui_str': 'Lamellar keratoplasty'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0010042', 'cui_str': 'Keratoplasty'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0085109', 'cui_str': 'Corneal neovascularization'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",9.0,0.0115853,The ulcer healing rates in LKP group (63.6) were significantly higher than AMT group (30) (P < 0.05).,"[{'ForeName': 'Yingxin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Ruiyao', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Minghong', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, The General Hospital of Northern Theater Command, Shenyang, PR China.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000007063']
3203,32947383,Effect of topical povidone-iodine 10% plus levofloxacin 0.5% one hour before cataract surgery in eliminating perioperative conjunctival flora: randomized clinical trial.,"PURPOSE


To evaluate the effect of a single administration of topical povidone-iodine (PVI) 10% plus levofloxacin 0.5%, at 1 hour before cataract surgery, on perioperative elimination rate of conjunctival flora.
SETTING


Poostchi Ophthalmology Research Center, Shiraz, Iran.
DESIGN


Randomized controlled trial.
METHOD


Patients who required cataract surgery were randomly assigned to one of two groups: intervention (administration of PVI 10% plus levofloxacin at 1 hour before surgery) or control. The patients in both groups received PVI just before the operation. Conjunctival cultures were obtained using thioglycollate broth at 4 timepoints including T1: before intervention; T2: before the second application of PVI; T3: 3 minutes after the second administration of PVI; and T4: just after the surgery.
RESULTS


The study comprised 142 patients.The comparative rates of positive cultures in the intervention vs control groups were as follows: T1 (70.4% vs 73.2%; P=0.709); T2 (15.5% % vs 71.8%; P<0.001,); T3 (7.0% vs 19.7%; P=0.027); and T4 (5.6% vs 4.2%; P=0.698). Coagulase negative Staphylococci was the most common isolated microorganism.
CONCLUSIONS


Results showed that a single adjuvant application of PVI 10% plus levofloxacin 0.5% eyedrops at 1 hour before operation leads to a further increase in the rate of sterile conjunctiva just before the surgery.",2020,"T1 (70.4% vs 73.2%; P=0.709); T2 (15.5% % vs 71.8%; P<0.001,); T3 (7.0% vs 19.7%; P=0.027); and T4 (5.6% vs 4.2%; P=0.698).","['142 patients', 'Patients who required cataract surgery', 'Poostchi Ophthalmology Research Center, Shiraz, Iran']","['intervention (administration of PVI 10% plus levofloxacin at 1 hour before surgery) or control', 'topical povidone-iodine 10% plus levofloxacin', 'levofloxacin', 'topical povidone-iodine (PVI']","['perioperative elimination rate of conjunctival flora', 'rate of sterile conjunctiva']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0009758', 'cui_str': 'Conjunctival structure'}]",142.0,0.0689335,"T1 (70.4% vs 73.2%; P=0.709); T2 (15.5% % vs 71.8%; P<0.001,); T3 (7.0% vs 19.7%; P=0.027); and T4 (5.6% vs 4.2%; P=0.698).","[{'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Eslami', 'Affiliation': 'From the Department of Surgical Technologists, School of Nursing and Midwifery, Shiraz University of Medical Sciences (Eslami, Rezaei), Shiraz, Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences (Jamali, Nowroozzadeh), Shiraz, Eye Research Center, The Five Senses Institute, Rassoul Akram Hospital, Iran University of Medical Sciences (Sedaghat), Tehran, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Rezaei', 'Affiliation': ''}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Jamali', 'Affiliation': ''}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sedaghat', 'Affiliation': ''}, {'ForeName': 'M Hossein', 'Initials': 'MH', 'LastName': 'Nowroozzadeh', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000436']
3204,32947455,Adjuvant Guided Exercise Therapy Versus Self-Organized Activity in Patients With Major Depression.,"Exercise seems to be effective in reducing depression itself, as well as the risk of relapse. This study evaluated whether standardized guided exercise therapy (GET) in comparison with self-organized activity (SOA) is an effective augmentation therapy in depressive adults. A total of 111 inpatients (66.7% women; mean age, 45.05 ± 12.19 years) with major depression were randomly assigned to either GET or SOA. Interventions were performed three times a week, with each session lasting 50 minutes. Both GET and SOA exerted effects even after a short-term application of 6 weeks. GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027). The findings support the beneficial role of adjuvant GET in patients with major depression as a feasible treatment in a psychiatric short-term inpatient setting.",2020,"GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027).","['patients with major depression', 'depressive adults', 'Patients With Major Depression', '111 inpatients (66.7% women; mean age, 45.05 ± 12.19 years) with major depression']","['Adjuvant Guided Exercise Therapy Versus Self-Organized Activity', 'GET or SOA', 'self-organized activity (SOA', 'standardized guided exercise therapy (GET']","['depression symptom severity', 'improving suicidality', 'Hamilton Depression Scale', 'severity of diurnal variation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}]",111.0,0.0157758,"GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027).","[{'ForeName': 'Ida S', 'Initials': 'IS', 'LastName': 'Haussleiter', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Bolsinger', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Hans-Jörg', 'Initials': 'HJ', 'LastName': 'Assion', 'Affiliation': 'LWL Hospital Dortmund, Dortmund, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Psychiatry.'}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001240']
3205,32947459,"The Effects of Common Over-the-Counter Moisturizers on Skin Barrier Function: A Randomized, Observer-Blind, Within-Patient, Controlled Study.","BACKGROUND


Moisturizers possibly improve atopic dermatitis (AD) by restoration of skin barrier, although some have detrimental effects.
OBJECTIVE


The aim of the study was to estimate the effects of several routine moisturizers on barrier functions.
METHODS


This is a randomized, forearm-controlled, observer-blind study. Patients older than 12 years with clear to moderate AD were randomized to 1 of 4 moisturizers (Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline) applied to nonlesional skin of 1 forearm and no moisturizer to the opposite forearm for 4 weeks. Transepidermal water loss (TEWL), capacitance, pH, and TEWL after tape stripping were evaluated at weeks 0 and 4. In addition, participants without AD underwent baseline measurements only.
RESULTS


Twenty patients with AD completed the study. Baseline measurements between the AD group and 10 non-AD controls were similar. After the intervention (AD group), mean TEWL improved in the treated forearm and worsened in the untreated one, but the difference was not significant. There was no significant change in pH or in TEWL after tape stripping. Capacitance significantly improved in the moisturizer forearm. The study was underpowered as recruitment fell short.
CONCLUSIONS


The effects of moisturizers on nonlesional AD skin were small and need to be addressed when powering future studies. Broadening investigations beyond the classic barrier properties might be useful in future studies.",2020,"After the intervention (AD group), mean TEWL improved in the treated forearm and worsened in the untreated one, but the difference was not significant.","['Twenty patients with AD completed the study', 'Patients older than 12 years with clear to moderate AD']","['4 moisturizers (Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline']","['Skin Barrier Function', 'Capacitance', 'mean TEWL', 'Transepidermal water loss (TEWL), capacitance, pH, and TEWL after tape stripping', 'pH or in TEWL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0055144', 'cui_str': 'Cetaphil'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}]",20.0,0.0544485,"After the intervention (AD group), mean TEWL improved in the treated forearm and worsened in the untreated one, but the difference was not significant.","[{'ForeName': 'Yael Anne', 'Initials': 'YA', 'LastName': 'Leshem', 'Affiliation': 'From the Division of Dermatology, Beilinson Hospital, Petach Tikva, Israel.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McClanahan', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}]","Dermatitis : contact, atopic, occupational, drug",['10.1097/DER.0000000000000623']
3206,32947474,A Randomized Controlled Trial of Antithrombin Supplementation During Extracorporeal Membrane Oxygenation.,"OBJECTIVES


Supplementation of antithrombin might decrease the amount of heparin needed to achieve a given anticoagulation target during extracorporeal membrane oxygenation. However, exogenous antithrombin itself may increase the risk of bleeding. We conceived a study to evaluate the effect of antithrombin supplementation in adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure on heparin dose, adequacy of anticoagulation, and safety.
DESIGN


Prospective randomized controlled trial.
SETTING


ICUs of two Italian referral extracorporeal membrane oxygenation centers.
PATIENTS


Adult patients requiring venovenous extracorporeal membrane oxygenation for severe respiratory failure and unfractionated heparin for systemic anticoagulation.
INTERVENTIONS


Before extracorporeal membrane oxygenation start, patients were randomized to either receive antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was the total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2. Secondary outcomes were anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused. Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis. Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001). Supplementation of antithrombin did not decrease heparin dose (13.5 international units/kg/hr [9.6-17.9 international units/kg/hr] vs 15.1 international units/kg/hr [10.7-18.3 international units/kg/hr] in the treatment and control group, respectively; p = 0.33) and anti-Factor Xa levels (0.4 international units/mL [0.3-0.5 international units/mL] vs 0.3 international units/mL [0.2-0.5 international units/mL] in the treatment group and control group respectively; p = 0.65). Bleeding, blood product transfusions, and thrombosis were not different in the two groups.
CONCLUSIONS


Antithrombin supplementation may not decrease heparin requirement nor diminish the incidence of bleeding and/or thrombosis in adult patients on venovenous extracorporeal membrane oxygenation.",2020,Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001).,"['adult patients on venovenous extracorporeal membrane oxygenation', 'adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure', 'ICUs of two Italian referral extracorporeal membrane oxygenation centers', 'Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis', 'Adult patients requiring', 'for severe respiratory failure and unfractionated heparin for systemic anticoagulation']","['venovenous extracorporeal membrane oxygenation', 'Antithrombin supplementation', 'antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course', 'Antithrombin Supplementation', 'antithrombin supplementation', 'antithrombin']","['Antithrombin', 'anti-Factor Xa levels', 'risk of bleeding', 'bleeding and/or thrombosis', 'heparin dose, adequacy of anticoagulation, and safety', 'total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2', 'anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused', 'Bleeding, blood product transfusions, and thrombosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0427612', 'cui_str': 'Anti factor Xa measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1272061', 'cui_str': 'Activated partial thromboplastin time ratio'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.267968,Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Panigada', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Cucino', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Occhipinti', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Panarello', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Novembrino', 'Affiliation': ""Clinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ""Epidemiology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Protti', 'Affiliation': 'Department of Anesthesia and Intensive Care, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Lissoni', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arcadipane', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ISMETT IRCCS (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), UPMC, Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': 'Department of Anaesthesia and Critical Care, ""Fondazione IRCCS Ca\' Granda, Ospedale Maggiore Policlinico,"" Milan, Italy.'}]",Critical care medicine,['10.1097/CCM.0000000000004590']
3207,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
3208,32947492,Single Cycle Versus Multiple Cycles of Canalith Repositioning Procedure for Treatment of Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial.,"OBJECTIVE


To compare the treatment outcomes and complications of single cycle versus multiple cycles of the canalith repositioning procedure (CRP).
STUDY DESIGN


Randomized controlled trial.
SETTING


Academic tertiary referral center; Chiang Mai University, Thailand.
PATIENTS


One hundred and forty-three adults who had unilateral posterior canal benign paroxysmal positional vertigo (BPPV).
INTERVENTION


Therapeutic. Patients received either a single cycle or multiple cycles of the CRP in one session.
MAIN OUTCOME MEASURES


Rate of negative Dix-Hallpike test (DHT), rate of symptom improvement, dizziness handicap inventory score (DHI), and rate of complications.
RESULTS


At the 1st week and the 4th week recall visits after CRP the treatment outcomes between the single-CRP group and the multiple-CRP group showed no significant difference. The outcomes included: 1) rate of negative DHT (1st week: 76.9 and 76.7%, 4th week: 89.5 and 88.2%); 2) rate of complete recovery or improved symptoms (1st week: 92.3 and 91.7%; 4th week: 96.5 and 98.0%); 3) DHI scores (1st week: 22 and 28; 4th week: 6 and 10); and 4) complication rate (1st week: 12.5 and 20%; 4th week: 20 and 0%. Rate of complications in the single-CRP group (6.9%) during the 1st treatment was lower than in the multiple-CRP groups (21.1%) (p-value = 0.013).
CONCLUSION


A single cycle of CRP is as effective as multiple cycle CRP, with a lower incidence of complication and a decrease in the time for treatment. Single-cycle CRP is a more advantageous treatment for unilateral posterior canal BPPV. CLINICALTRIALS.
GOV IDENTIFIER


NCT02701218.",2020,"A single cycle of CRP is as effective as multiple cycle CRP, with a lower incidence of complication and a decrease in the time for treatment.","['Posterior Canal Benign Paroxysmal Positional Vertigo', 'Academic tertiary referral center; Chiang Mai University, Thailand', 'One hundred and forty-three adults who had unilateral posterior canal benign paroxysmal positional vertigo (BPPV']","['canalith repositioning procedure (CRP', 'CRP', 'Canalith Repositioning Procedure']","['1) rate of negative DHT', '4) complication rate', 'DHI scores', '2) rate of complete recovery or improved symptoms', 'Rate of negative Dix-Hallpike test (DHT), rate of symptom improvement, dizziness handicap inventory score (DHI), and rate of complications', 'Rate of complications']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C1096698', 'cui_str': 'Canalith repositioning procedure'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",143.0,0.0827658,"A single cycle of CRP is as effective as multiple cycle CRP, with a lower incidence of complication and a decrease in the time for treatment.","[{'ForeName': 'Suwicha Kaewsiri', 'Initials': 'SK', 'LastName': 'Isaradisaikul', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai.'}, {'ForeName': 'Sanathorn', 'Initials': 'S', 'LastName': 'Chowsilpa', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai.'}, {'ForeName': 'Charuk', 'Initials': 'C', 'LastName': 'Hanprasertpong', 'Affiliation': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University, Chiang Mai.'}, {'ForeName': 'Tayaporn', 'Initials': 'T', 'LastName': 'Rithirangsriroj', 'Affiliation': 'Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002894']
3209,32947578,An Implementation Approach Comparison of a Child Care Center-Based Obesity Prevention Program.,"OBJECTIVE


To compare the effectiveness of the Healthy Caregivers-Healthy Children (HC2) phase 1 (2011-2014) and 2 (2015-2018) child care center (CCC)-based obesity prevention intervention(s) on child dietary practices and body mass index percentile (PBMI) outcomes over 2 years. Phase 1 was implemented via a university-based research team, and phase 2 was delivered via a train-the-trainers approach (university-based research team trains preschool-based coaches, who in turn train CCC teachers to implement and disseminate HC2).
METHODS


Phase 1 and 2 were both cluster randomized controlled trials of the HC2 obesity prevention intervention. Phase 1 was composed of 1224 children in 28 CCCs (12 intervention and 16 control). Phase 2 was composed of 825 children in 24 CCCs (12 intervention and 12 control). Both phases included CCCs serving low-resource, predominantly ethnic minority families.
RESULTS


The mean rate of weekly fruit consumption significantly increased (β = 0.16, p = 0.001) in phase 1, whereas vegetable intake significantly increased (β = 0.16, p = 0.002) in phase 2 intervention CCCs. Fried (β = -0.36, p < 0.001), fast (β = -0.16, p = 0.001), and other unhealthy food (β = -0.57, p < 0.001) consumption significantly decreased in phase 1 only. The mean rate of snack food consumption significantly decreased in phase 2 (β = -0.97, p < 0.001). Mean child PBMI remained in the healthy range over 2 years for all groups in both study phases.
CONCLUSION


A university-based research team implementation and dissemination approach seemed to be more effective than a train-the-trainers implementation method in improving dietary intake patterns. This finding suggests that CCCs may need robust educational support beyond their existing internal resources for long-term positive dietary intake pattern changes.",2020,"The mean rate of weekly fruit consumption significantly increased (β = 0.16, p = 0.001) in phase 1, whereas vegetable intake significantly increased (β = 0.16, p = 0.002) in phase 2 intervention CCCs.","['825 children in 24 CCCs (12 intervention and 12 control', 'Healthy Caregivers-Healthy Children (HC2) phase 1 (2011-2014) and 2 (2015-2018) child care center (CCC)-based obesity prevention intervention(s) on child dietary practices and body mass index percentile', '1224 children in 28 CCCs (12 intervention and 16 control']","['HC2 obesity prevention intervention', 'Child Care Center-Based Obesity Prevention Program']","['mean rate of weekly fruit consumption', 'mean rate of snack food consumption', 'vegetable intake', 'Mean child PBMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0389225,"The mean rate of weekly fruit consumption significantly increased (β = 0.16, p = 0.001) in phase 1, whereas vegetable intake significantly increased (β = 0.16, p = 0.002) in phase 2 intervention CCCs.","[{'ForeName': 'Ruby A', 'Initials': 'RA', 'LastName': 'Natale', 'Affiliation': 'Department of Pediatrics, University of Miami, Miami, FL.'}, {'ForeName': 'Folefac', 'Initials': 'F', 'LastName': 'Atem', 'Affiliation': 'Department of Biostatistics, University of Texas Health Science Center School of Public Health, Dallas Campus, Dallas TX.'}, {'ForeName': 'Sitara', 'Initials': 'S', 'LastName': 'Weerakoon', 'Affiliation': 'Department of Biostatistics, University of Texas Health Science Center School of Public Health, Dallas Campus, Dallas TX.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lebron', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'M Sunil', 'Initials': 'MS', 'LastName': 'Mathew', 'Affiliation': 'Department of Biostatistics, University of Texas Health Science Center School of Public Health, Dallas Campus, Dallas TX.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Sardinas', 'Affiliation': 'Department of Pediatrics, University of Miami, Miami, FL.'}, {'ForeName': 'Catherina', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Ron and Kathy Assaf College of Nursing, Nova Southeastern University, Davie, FL.'}, {'ForeName': 'Karla P', 'Initials': 'KP', 'LastName': 'Shelnutt', 'Affiliation': 'Department of Family, Youth and Community Sciences, University of Florida, Gainesville, FL.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Spector', 'Affiliation': ""The Children's Trust, Miami, FL.""}, {'ForeName': 'Fiorella', 'Initials': 'F', 'LastName': 'Altare', 'Affiliation': 'Early Learning Coalition, Miami, FLDepartment of Epidemiology, Human Genetics & Environmental Sciences, University of Texas Health Science Center School of Public Health, Dallas Campus, Dallas, TX.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': 'Department of Pediatrics, University of Miami, Miami, FL.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000861']
3210,32947581,Mindfulness-Based College: A Stage 1 Randomized Controlled Trial for University Student Well-Being.,"OBJECTIVE


To evaluate effects of a mindfulness-based program, adapted to the young adult life course stage (age 18-29), named Mindfulness-Based College (MB-College). The primary outcome was a young adult health summary score, composed of key health risk factors: body mass index, physical activity, fruit and vegetable intake, alcohol consumption, stress, loneliness, and sleep duration. Secondary outcomes were hypothesized self-regulation mechanisms, including attention control, interoceptive awareness, and emotion regulation.
METHODS


This was a Stage 1 randomized controlled trial of the 9-week MB-College program (n=47) vs. enhanced usual care control (n=49) including students from three universities. Assessments were at baseline, during the beginning of the college term when stress is typically lower, and at MB-College completion (three months follow-up), when term-related stress is typically higher. Intention to treat, linear regression analyses estimated the marginal effects of MB-College vs. control on the outcomes.
RESULTS


MB-College participants (mean age 20 y, 68% female, 37% racial minorities) demonstrated improved health summary scores at follow-up, compared to control participants whose health summary scores worsened (marginal effect for MB-College vs. control=0.23; p=0.004). Effects on loneliness were pronounced (marginal effect=-3.11 for R-UCLA score; p=0.03). Secondary analyses showed significant impacts of MB-College on hypothesized self-regulation mechanisms (e.g. Sustained Attention to Response Task correct no-go percent, p=0.0008; Multidimensional Assessment of Interoceptive Awareness, p<0.0001; Center for Epidemiologic Studies-Depression scale, p=0.03).
CONCLUSIONS


Findings of this early stage clinical trial suggest that MB-College may foster well-being in young adults.
TRIAL REGISTRATION


NCT03124446.",2020,Effects on loneliness were pronounced (marginal effect=-3.11 for R-UCLA score; p=0.03).,"['young adults', 'n=49) including students from three universities', 'young adult life course stage (age 18-29), named Mindfulness-Based College (MB-College', 'Mindfulness-Based College']","['mindfulness-based program', 'MB-College program (n=47) vs. enhanced usual care control']","['health summary scores', 'hypothesized self-regulation mechanisms, including attention control, interoceptive awareness, and emotion regulation', 'loneliness', 'MB-College on hypothesized self-regulation mechanisms (e.g. Sustained Attention to Response Task correct no-go percent, p=0.0008; Multidimensional Assessment of Interoceptive Awareness, p<0.0001; Center for Epidemiologic Studies-Depression scale, p=0.03', 'young adult health summary score, composed of key health risk factors: body mass index, physical activity, fruit and vegetable intake, alcohol consumption, stress, loneliness, and sleep duration']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}]",,0.126357,Effects on loneliness were pronounced (marginal effect=-3.11 for R-UCLA score; p=0.03).,"[{'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Loucks', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Nardi', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Gutman', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Frances B', 'Initials': 'FB', 'LastName': 'Saadeh', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Vago', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Fiske', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Jayson J', 'Initials': 'JJ', 'LastName': 'Spas', 'Affiliation': 'Department of Psychology, Rhode Island College, Providence, Rhode Island, United States of America.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Harrison', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, United States of America.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000860']
3211,32947587,Impact of Skin Suture Pattern on Incision Perfusion Using Intraoperative Laser Angiography: A Randomized Clinical Trial of Patients With Ankle Fractures.,"OBJECTIVES


To assess which skin suture pattern-simple, vertical mattress, horizontal mattress, Allgöwer-Donati (AD), or running subcuticular-enables the greatest degree of perfusion as measured by indocyanine green laser angiography after ankle fracture surgery.
DESIGN


Prospective, randomized.
SETTING


Level 1 Academic Trauma Center.
PATIENTS/PARTICIPANTS


Seventy-five patients undergoing ankle fracture surgery were prospectively randomized to 1 of 5 skin suture patterns (n = 15 per cohort). Patient demographics and operative parameters were similar between groups.
MAIN OUTCOME MEASUREMENTS


Skin perfusion was assessed intraoperatively after skin closure using indocyanine green laser angiography and quantified in fluorescence units. Two perfusion values were collected: (1) mean incision perfusion was the mean of 10 points along the incision and (2) mean perfusion impairment was the perfusion difference between the incision and the skin adjacent to it. We also collected a postoperative patient scar assessment score.
RESULTS


Running subcuticular closure had significantly better mean incision perfusion than all other closure patterns. Mean perfusion impairment also favored running subcuticular closure, which was significantly lower than all other suture patterns except AD. We found no patient perceived cosmetic differences between the 5 suture pattern types.
CONCLUSIONS


Running subcuticular suture pattern resulted in the greatest incision perfusion than simple, horizontal mattress, vertical mattress, and AD techniques after ankle fracture fixation.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Mean perfusion impairment also favored running subcuticular closure, which was significantly lower than all other suture patterns except AD.","['Patients With Ankle Fractures', 'Level 1 Academic Trauma Center', 'Seventy-five patients undergoing ankle fracture surgery']","['Skin Suture Pattern on Incision Perfusion Using Intraoperative Laser Angiography', 'skin suture pattern-simple, vertical mattress, horizontal mattress, Allgöwer-Donati (AD), or running subcuticular', '5 skin suture patterns', 'indocyanine green laser angiography']","['Mean perfusion impairment', 'greatest incision perfusion', 'Skin perfusion was assessed intraoperatively after skin closure using indocyanine green laser angiography and quantified in fluorescence units', 'mean incision perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0191408', 'cui_str': 'Closure of skin by suture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",75.0,0.110502,"Mean perfusion impairment also favored running subcuticular closure, which was significantly lower than all other suture patterns except AD.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Shorten', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, University of Vermont Medical Center, Burlington, VT.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haimes', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nesbit', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Bartlett', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schottel', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001787']
3212,32947595,Cost-Effectiveness of Volar Locking Plate Compared with Augmented External Fixation for Displaced Intra-Articular Wrist Fractures.,"BACKGROUND


The purpose of the present study was to estimate the cost-effectiveness of treating displaced, intra-articular distal radial fractures with volar locking plate fixation compared with augmented external fixation.
METHODS


A cost-utility analysis was conducted alongside a randomized, clinical trial comparing 2 surgical interventions for intra-articular distal radial fractures. One hundred and sixty-six patients were allocated to either volar locking plate fixation (84 patients) or external fixation (82 patients) and were followed for 2 years. Health-related quality of life was assessed with the EuroQol-5 Dimensions and was used to calculate patients' quality-adjusted life-years (QALYs). Resource use was identified prospectively at the patient level at all follow-up intervals. Costs were estimated with use of both a health-care perspective and a societal perspective. Results were expressed in incremental cost-effectiveness ratios, and uncertainty was assessed with use of bootstrapping methods.
RESULTS


The average QALY value was equivalent between the groups (1.70463 for the volar locking plate group and 1.70726 for the external fixation group, yielding a nonsignificant difference of -0.00263 QALY). Health-care costs were equal between the groups, with a nonsignificant difference of &OV0556;52 (p = 0.8) in favor of external fixation. However, the external fixation group had a higher loss of productivity due to absence from work (5.5 weeks in the volar locking plate group compared with 9.2 weeks for the external fixation group; p = 0.02). Consequently, the societal costs were higher for the external fixation group compared with the volar locking plate group (&OV0556;18,037 compared with &OV0556;12,567, representing a difference of &OV0556;5,470; p = 0.04) in favor of the volar locking plate group. Uncertainty analyses showed that there is indifference regarding which method to recommend from a health-care perspective, with volar locking plate treatment and external fixation having a 47% and 53% likelihood of being cost-effective, respectively. From the societal perspective, volar locking plate treatment had a 90% likelihood of being cost-effective.
CONCLUSIONS


External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work.
LEVEL OF EVIDENCE


Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"CONCLUSIONS


External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work.
","['Displaced Intra-Articular Wrist Fractures', 'intra-articular distal radial fractures', 'One hundred and sixty-six patients']","['External fixation', 'volar locking plate fixation (84 patients) or external fixation', 'volar locking plate', 'volar locking plate fixation compared with augmented external fixation', 'Volar Locking Plate Compared with Augmented External Fixation', 'volar locking plate treatment']","['cost-effectiveness', 'Cost-Effectiveness', 'Health-care costs', 'societal costs', 'Health-related quality of life', 'cost-effective', 'incremental cost-effectiveness ratios, and uncertainty', 'average QALY value']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0435630', 'cui_str': 'Fracture of distal end of radius and ulna'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",166.0,0.0457825,"CONCLUSIONS


External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work.
","[{'ForeName': 'Ola-Lars', 'Initials': 'OL', 'LastName': 'Hammer', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Rune Bruhn', 'Initials': 'RB', 'LastName': 'Jakobsen', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Stale', 'Initials': 'S', 'LastName': 'Clementsen', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Fuglesang', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Gudrun Waaler', 'Initials': 'GW', 'LastName': 'Bjornelv', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Per-Henrik', 'Initials': 'PH', 'LastName': 'Randsborg', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01288']
3213,32947994,A Pilot Evaluation of a Smartphone Application for Workplace Depression.,"Interventions delivered via mobile apps show particular promise in tackling the burden of common mental disorders. Appropriately targeting these interventions to at-risk populations is critical to their success. This pilot study aimed to assess the usability, feasibility, acceptability, and preliminary effects of an app-based intervention designed to target depressive symptoms in a stressed working population. Anchored, a smartphone app including a 30-day program of mindfulness and cognitive and behavioural therapeutic components, was tested in a pre-post pilot study with participants recruited via social media advertisements. Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure. Follow-up assessment occurred 5 weeks after baseline. The primary outcome measure was change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance. User feedback and in-app data were analysed to assess engagement and intervention adherence. At follow-up, there were significant reductions in depressive symptoms (t 61  = 6.35;  p  < 0.001) and anxiety symptoms (t 60  = 7.35;  p  < 0.001), along with significantly reduced cases of likely new onset depression compared to baseline (24% vs. 6%,  p =  0.012). Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001). Participants reported no significant changes in work performance, absenteeism or exercise. There were satisfactory levels of app usability, feasibility, and acceptability. Most participants found the app easy to use (93.2%), understood the app content well (83.0%), and rated the app highly or very highly overall (72.9%). User feedback suggestions were predominantly focused on improving app navigation and user interface. This pilot study provides encouraging evidence that Anchored has potentially beneficial effects, and is usable, feasible, and acceptable as an app-based intervention for the working population experiencing elevated stress. Further testing of Anchored in a randomised controlled trial is required to investigate its efficacy as an intervention for workplace mental ill-health.",2020,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","['Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure', 'stressed working population', 'participants recruited via social media advertisements', 'Workplace Depression', 'workplace mental ill-health']",['Smartphone Application'],"['wellbeing', 'usability, feasibility, acceptability', 'anxiety symptoms', 'change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance', 'satisfactory levels of app usability, feasibility, and acceptability', 'work performance, absenteeism or exercise', 'depressive symptoms', 'new onset depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",81.0,0.281056,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","[{'ForeName': 'Daniel A J', 'Initials': 'DAJ', 'LastName': 'Collins', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Lavender', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre, Central Clinical School, Faculty of Medicine and Health, University of Sydney,Sydney, NSW 2050, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186753']
3214,32948045,Comparison of the Effects of Visual and Auditory Distractions on Fistula Cannulation Pain among Older Patients Undergoing Hemodialysis: A Randomized Controlled Clinical Trial.,"Pain associated with fistula cannulation is a challenge for nurses who provide care to older patients undergoing hemodialysis. Several non-pharmacological methods have been suggested for relieving fistula cannulation pain, but the benefits of visual and auditory distraction methods among older patients undergoing hemodialysis have not been investigated yet. Therefore, this study aimed to compare the effects of visual and auditory distractions on fistula cannulation pain among older patients undergoing hemodialysis. This randomized controlled clinical trial was conducted on 120 older patients undergoing hemodialysis. They were randomly assigned to three groups of visual distraction, auditory distraction, and the control ( n  = 40 in each group) using a simple random assignment method. The distraction interventions continued for three consecutive sessions and the numeric rating scale of pain severity was used for data collection. Descriptive and inferential statistics were used for data analysis using SPSS. It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001). However, visual distraction had a better effect on the reduction of pain severity. Therefore, while both visual and auditory distractions reduced pain severity in older patients undergoing hemodialysis, visual distraction was more effective. Nurses are encouraged to incorporate visual distraction as a safe and non-pharmacologic technique into routine nursing care for reducing older patients' suffering and improving their wellbeing when fistula cannulation is performed.",2020,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"['Older Patients Undergoing Hemodialysis', 'older patients undergoing hemodialysis', 'older patients undergoing', '120 older patients undergoing hemodialysis']","['Visual and Auditory Distractions', 'hemodialysis, visual distraction', 'fistula cannulation', 'visual and auditory distractions', 'visual distraction, auditory distraction, and the control']","['fistula cannulation pain', 'Fistula Cannulation Pain', 'Pain', 'numeric rating scale of pain severity', 'pain severity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0398348,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"[{'ForeName': 'Mina Ghadimi', 'Initials': 'MG', 'LastName': 'Aghbolagh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bahrami', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Rejeh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Majideh', 'Initials': 'M', 'LastName': 'Heravi-Karimooi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Tadrisi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran 1435916471, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5030053']
3215,32948108,Analogy and explicit motor learning in dynamic balance: Posturography and performance analyses.,"Unlike explicit learning, analogy learning allows learners to acquire skills with a movement metaphor with fewer verbal knowledge accumulated during early learning, resulting in less reliance on cognitive resources for better motor performances. However, the efficacy of analogical instruction on balance is still unclear. This study examined learning and subsequent performance (including posturography) of a Y-balance task by explicit and analogical instructions. Forty female undergraduates were randomly assigned either into analogy (n = 20) or explicit (n = 20) learning. Both group learners completed pre-learning test-block on Day 1 (6 trials), five consecutive learning blocks from Days 3 to 7 (135 trials) and followed by test-blocks on Day 9 (retention 1 -dual task - retention 2 design, 18 trials). Maximum reaching distance in anterior, posterolateral and posteromedial directions were measured to indicate Y-balance performance. During test-blocks (pre-learning, retention 1, dual-task, retention 2), CoM displacement and CoP excursion were quantified with motion capturing system and force platform, respectively. Results indicated that maximum reach distances of two groups increased across learning days ( p <.001). During test-blocks, explicit learners reduced maximum reaching distances under dual-task test than retention test 1 ( p  < .001), while analogy learners remained robust performance across test-blocks ( p  = .071). Moreover, analogy learners reported fewer explicit knowledge and demonstrated better counting backward performance than explicit learners. These findings suggest that introducing an analogical instruction in dynamic balance training is feasible and has implications to develop balance training strategies for injury prevention and performance enhancement.",2020,Results indicated that maximum reach distances of two groups increased across learning days ( p <.001).,['Forty female undergraduates'],['analogical instruction'],"['CoM displacement and CoP excursion', 'explicit knowledge', 'maximum reach distances']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0009490', 'cui_str': 'Comoros islands'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0299465,Results indicated that maximum reach distances of two groups increased across learning days ( p <.001).,"[{'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Guangdong Provincial Engineering Technology Research Center for Sports Assistive Devices, Guangzhou Sport University, Guangzhou, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Biomechanics Laboratory, Beijing Sports University, Beijing, China.'}, {'ForeName': 'Wing-Kai', 'Initials': 'WK', 'LastName': 'Lam', 'Affiliation': 'Guangdong Provincial Engineering Technology Research Center for Sports Assistive Devices, Guangzhou Sport University, Guangzhou, China.'}]",European journal of sport science,['10.1080/17461391.2020.1827046']
3216,32948109,"Age-Related Differences in Mood, Diabetes-Related Distress, and Functional Outcomes in Adults With Type 2 Diabetes Mellitus and Comorbid Obstructive Sleep Apnea and Insomnia.","PURPOSE


The purpose of this study was to examine age-related differences in mood, diabetes-related distress, and functional outcomes in activities sensitive to impaired sleep in adults with type 2 diabetes mellitus (T2DM) and comorbid obstructive sleep apnea (OSA) and insomnia. This study also evaluated the associations of age, insomnia severity, and OSA severity on outcome variables.
METHODS


This study was a secondary analysis of pooled baseline data from 2 randomized controlled trials among adults with T2DM with symptoms of sleep disorders (N = 145,109 younger adults, 36 older adults; 46.2% male; 67.6% white). Comorbid OSA and insomnia was defined as Apnea-Hypopnea Index ≥5 events per hour and Insomnia Severity Index ≥10. Outcome variables included mood, diabetes-related distress, and functional outcomes.
RESULTS


Older adults reported better mood, lower diabetes-related distress, and higher functional outcomes relative to younger adults (all  P s < .05). Insomnia severity was associated with worse mood ( b  = 2.59,  P  < .001) and diabetes-related distress ( b  = 1.40,  P  < .001) and lower functional outcome ( b  = -0.22,  P  < .001). Older age was associated with lower diabetes-related distress ( b  = -0.44,  P  = .040).
CONCLUSION


Older age was a protective factor of mood disturbance, diabetes-related distress, and functional impairment in adults with T2DM and comorbid OSA and insomnia. Insomnia severity was associated with greater mood disturbance, diabetes-related distress, and functional impairment when OSA and insomnia coexist. The results suggest that diabetes care and education specialists should assess patients for impaired sleep.",2020,"Older age was associated with lower diabetes-related distress ( b  = -0.44,  P  = .040).
","['adults with T2DM with symptoms of sleep disorders (N = 145,109 younger adults, 36 older adults; 46.2% male; 67.6% white', 'Adults With Type 2 Diabetes Mellitus and Comorbid Obstructive Sleep Apnea and Insomnia', 'adults with T2DM and comorbid OSA and insomnia', 'adults with type 2 diabetes mellitus (T2DM) and comorbid obstructive sleep apnea (OSA) and insomnia']",[],"['diabetes-related distress', 'mood, diabetes-related distress, and functional outcomes', 'lower functional outcome', 'Insomnia severity', 'Comorbid OSA and insomnia', 'Apnea-Hypopnea Index ≥5 events per hour and Insomnia Severity Index ≥10']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",145109.0,0.0291424,"Older age was associated with lower diabetes-related distress ( b  = -0.44,  P  = .040).
","[{'ForeName': 'Bomin', 'Initials': 'B', 'LastName': 'Jeon', 'Affiliation': 'University of Pittsburgh, School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sereika', 'Affiliation': 'University of Pittsburgh, School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Callan', 'Affiliation': 'University of Pittsburgh, School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Faith S', 'Initials': 'FS', 'LastName': 'Luyster', 'Affiliation': 'University of Pittsburgh, School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'DiNardo', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eileen R', 'Initials': 'ER', 'LastName': 'Chasens', 'Affiliation': 'University of Pittsburgh, School of Nursing, Pittsburgh, Pennsylvania.'}]",The Diabetes educator,['10.1177/0145721720958396']
3217,32947176,Effectiveness of a school-based road safety educational program for lower secondary school students in Denmark: A cluster-randomized controlled trial.,"Road accidents are one of the leading causes of death and injuries among adolescents and young adults. Road safety education programs aim to promote safe traffic behavior through information, skills training or fear appeals. During the last decade, an intervention type using victim testimonials has been developed. These types of programs aim to promote road safety by connecting a personal narrative of choices and consequences to the beliefs and behaviors of the audience. Studies on the effectiveness of this type of road safety programs among youngsters who are not yet drivers are still limited. This study used a cluster-randomized and controlled trial design to examine the effect of a Danish school-based road safety educational program using testimonials for students in lower secondary schools in Denmark on a) knowledge of risks factors in traffic and b) two types of behavior specifically relevant for the pre-driver target group: seatbelt use and safe bicycle behavior. Our analysis sample comprised 1007 students from 57 schools with a matched baseline and four-month follow-up response. Linear regression analyses suggest a small positive effect on the students' knowledge of the three most important risk factors in traffic but not on the age group most at risk. Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use. Neither was the effectiveness modified by gender, parental educational background, or risky cycling behavior at baseline. Although classroom-based interventions using testimonials may have the potential to increase knowledge of risk factors in traffic among adolescents, translating knowledge into safe traffic behavior is challenging. More studies are needed on how to further adapt the intervention to an age group who are not yet drivers. Such research may focus on mechanisms of change including the age-specific relevance of the ambassador's testimonial and on employing strong elements of action guidance.",2020,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","['students in lower secondary schools in Denmark on a', 'lower secondary school students in Denmark', '1007 students from 57 schools with a matched baseline and four-month follow-up response', 'youngsters who are not yet drivers', 'adolescents and young adults']","['school-based road safety educational program', 'Danish school-based road safety educational program']","['effectiveness modified by gender, parental educational background, or risky cycling behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",1007.0,0.0370321,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","[{'ForeName': 'Anders Bo', 'Initials': 'AB', 'LastName': 'Bojesen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark.'}, {'ForeName': 'Signe Boe', 'Initials': 'SB', 'LastName': 'Rayce', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark. Electronic address: sbo@vive.dk.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105773']
3218,32947496,Translational Studies on Biologic Fusion of a Vertebral Segment as a Novel Treatment Modality for Low Back Pain.,"STUDY DESIGN


Preclinical studies: Efficacy and toxicological studies on lactic acid (LA)-induced sclerozation in pig lumbar discs. Clinical study: Prospective, randomised, double-blinded, placebo-controlled, single ascending dose study investigating the safety and local tolerability of LA.
OBJECTIVE


To determine if LA produces sclerozation of the porcine NP followed by a phase Ib study to evaluate preliminary safety, tolerability and efficacy of LA in patients with chronic discogenic low back pain.
SUMMARY OF BACKGROUND DATA


Surgical stabilization of a motion segment harboring a painful degenerated disc often affords symptomatic relief. In the present study, the hypothesis was tested that LA can produce sclerozation and stabilization of the nucleus pulposus (NP).
METHODS


LA (0.2 mL; 60, 120 or 240 mg/mL) or vehicle was injected into the NP or close to the extra spinal region of spinal nerves of young female pigs. The size of the NP, MRI changes, flexural stiffness and histology of the disc was studied after up to 84 days of survival. Fifteen patients injected intra discally with placebo (iohexol, 1.5 mL, n = 6) or iohexol plus LA (30, 60 or 120 mg/mL; 3 patients in each group) were followed for up to 12 months.
RESULTS


Injection of LA in the pig reproducibly induced sclerozation of the NP and increased flexural rigidity. Histological changes included generation of connective tissue and increased expression of collagen I. No safety concerns were raised. Adverse events in patients were limited to transiently increased low back pain with no obvious difference between treatment groups. There was indication of lower water content of NP injected with the 2 highest doses of LA.
CONCLUSIONS


LA has a sclerozing effect on the NP in pigs and patients and is therefore a candidate for further clinical studies powered to determine its potential as a treatment of chronic discogenic low back pain.
LEVEL OF EVIDENCE


2.",2020,Histological changes included generation of connective tissue and increased expression of collagen I. No safety concerns were raised.,"['Low Back Pain', 'patients with chronic discogenic low back pain', 'Fifteen patients injected intra discally with', 'pig lumbar discs', 'young female pigs', 'LA (0.2\u200amL']","['LA', 'placebo', 'placebo (iohexol, 1.5\u200amL, n\u200a=\u200a6) or iohexol plus LA']","['low back pain', 'generation of connective tissue and increased expression of collagen I. No safety concerns', 'Adverse events', 'safety and local tolerability', 'sclerozation of the NP and increased flexural rigidity', 'size of the NP, MRI changes, flexural stiffness and histology of the disc']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1185714', 'cui_str': 'Nucleus Pulposus'}, {'cui': 'C0439748', 'cui_str': 'Flexural'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",15.0,0.118782,Histological changes included generation of connective tissue and increased expression of collagen I. No safety concerns were raised.,"[{'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Olmarker', 'Affiliation': 'Musculoskeletal Research, Department of Medical Chemistry and Cell Biology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gerward', 'Affiliation': 'Stayble Therapeutics AB, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Isberg', 'Affiliation': 'Department of Radiology, Läkarhuset Odenplan, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lehmann', 'Affiliation': 'Stayble Therapeutics AB, Gothenburg, Sweden.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': 'Stockholm Spine Center, Löwenströmska Hospital, Upplands Väsby, Sweden.'}]",Spine,['10.1097/BRS.0000000000003699']
3219,32947541,"Balloon compression versus radiofrequency for primary trigeminal neuralgia: a randomized, controlled trial.","Surgical procedures are necessary in up to 50% of trigeminal neuralgia (TN) patients. While radiofrequency (RF) is more widely used, it is associated with high intra-procedural costs and long technical learning time. Other simpler procedures such as balloon compression (BC) require a lower training period and have significant lower costs. We evaluated the effects of BC and RF in pain control in primary TN in a randomized, double-blinded, head-to-head trial. Individuals were randomly allocated in one of two groups: BC and RF. Throughout pain, psychological and quality of life measurements were performed at baseline and after surgery. The main outcome was the worst pain in the last 24 hours (0-10) at six months postoperatively. After the inclusion of half of the estimated sample, a pre-planned interim analysis was performed when thirty-three patients (62.1 ± 9.4 y.) completed the study. Pain intensity (CI95% 0.6-3.8, and -0.6-2.2, for BC and RF) did not significantly differ. Complications, interference of pain in daily life (CI95% -0.1-2.3 and -0.4-2.3, for BC and RF), neuropathic pain symptoms (CI95% 1.7-3.6 and 3.0-5.7, for BC and RF), mood (CI95% 4.8-11.5 and 5.5-15.1, BC and RF, respectively), medication use and quality of life (CI95% 80.4-93.1 and 83.9-94.2, for BC and RF) were also not different. RF presented more paresthetic symptoms than BC at 30 days following intervention. Based on these results, the study was halted due to futility as BC was not superior do RF.",2020,"Pain intensity (CI95% 0.6-3.8, and -0.6-2.2, for BC and RF) did not significantly differ.",['primary trigeminal neuralgia'],"['radiofrequency (RF', 'BC and RF', 'Balloon compression versus radiofrequency']","['medication use and quality of life', 'neuropathic pain symptoms', 'Complications, interference of pain in daily life', 'worst pain', 'pain, psychological and quality of life measurements', 'paresthetic symptoms', 'Pain intensity']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040997', 'cui_str': 'Trigeminal neuralgia'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.164675,"Pain intensity (CI95% 0.6-3.8, and -0.6-2.2, for BC and RF) did not significantly differ.","[{'ForeName': 'Hugo Sterman', 'Initials': 'HS', 'LastName': 'Neto', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Cristiane Yoko', 'Initials': 'CY', 'LastName': 'Fukuda', 'Affiliation': 'Department of Anesthesiologie and Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Kleber Paiva', 'Initials': 'KP', 'LastName': 'Duarte', 'Affiliation': 'Department and Institute of Psychiatry, School of Medicine, University of São Paulo, Service of Interdisciplinary Neuromodulation, São Paulo, SP, Brazil.'}, {'ForeName': 'Valquíria', 'Initials': 'V', 'LastName': 'Aparecida da Silva', 'Affiliation': 'Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Lilian de Lima Rodrigues', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ricardo Galhardoni', 'Initials': 'RG', 'LastName': 'Geront', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo Pain Center, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Silvia R D T', 'Initials': 'SRDT', 'LastName': 'de Siqueira', 'Affiliation': 'School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'José Tadeu', 'Initials': 'JT', 'LastName': 'Tesseroli de Siqueira', 'Affiliation': 'School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Manoel Jacobsen', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo Pain Center, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ciampi de Andrade', 'Affiliation': 'LIM-62, Pain Center Department of Neurology, University of São Paulo, Brazil.'}]",Pain,['10.1097/j.pain.0000000000002070']
3220,32947547,Optimized acupuncture treatment (acupuncture and intradermal needling) for cervical spondylosis-related neck pain: a multicenter randomized controlled trial.,"Cervical spondylosis (CS)-related neck pain is difficult to treat due to its degenerative nature. The aim of this nine-center, single-blinded, randomized controlled trial was to evaluate the efficacy of optimized acupuncture for CS-related neck pain. Participants who met the inclusion criteria were randomized to optimized, shallow, and sham acupuncture groups (1:1:1). The primary outcome was the change from baseline in the Northwick Park Neck Pain Questionnaire (NPQ) score at week 4. Participants were followed up until week 16. Of the 896 randomized participants, 857 received ≥1 intervention session; 280, 286, and 291 received optimized, shallow, and sham acupuncture, respectively. A total of 835 (93.2%) participants completed the study. At week 4, significant differences (P<0.001) were observed in the changes in NPQ scores between the optimized acupuncture group and both the shallow (7.72 [95% confidence interval {CI}, 5.57-9.86]) and sham acupuncture groups (10.38 [95%CI, 8.25-12.52]). The difference in the scores at week 16 between the optimized acupuncture group and the shallow (8.84 [95%CI, 6.34-11.34]) and sham acupuncture (10.81 [95%CI, 8.32-13.30]) groups were significant. The center effect indicated wide variability in the treatment effects (Cohen's d=0.01-2.19). Most SF-36 scores were higher in the optimized acupuncture group than in the other groups. These results suggest that 4-week optimized acupuncture treatment alleviates CS-related neck pain and improves the quality of life, with the effects persisting for minimum 3 months. Therefore, acupuncture can have positive effects on CS-related neck pain, although the effect size may vary widely.",2020,"At week 4, significant differences (P<0.001) were observed in the changes in NPQ scores between the optimized acupuncture group and both the shallow (7.72 [95% confidence interval {CI}, 5.57-9.86]) and sham acupuncture groups (10.38 [95%CI, 8.25-12.52]).","['cervical spondylosis-related neck pain', '896 randomized participants, 857 received ≥1 intervention session; 280, 286, and 291 received', 'Cervical spondylosis (CS)-related neck pain', 'Participants who met the inclusion criteria', 'A total of 835 (93.2%) participants completed the study']","['acupuncture treatment (acupuncture and intradermal needling', 'acupuncture', 'optimized, shallow, and sham acupuncture']","['NPQ scores', 'quality of life', 'CS-related neck pain', 'Most SF-36 scores', 'Northwick Park Neck Pain Questionnaire (NPQ) score']","[{'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}]",896.0,0.575719,"At week 4, significant differences (P<0.001) were observed in the changes in NPQ scores between the optimized acupuncture group and both the shallow (7.72 [95% confidence interval {CI}, 5.57-9.86]) and sham acupuncture groups (10.38 [95%CI, 8.25-12.52]).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Minying', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Traditional Therapy Center, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'York University, Toronto, Canada.'}, {'ForeName': 'Zhiyan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Urumqi, China.'}, {'ForeName': 'Lingmei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Acupuncture and Massage, Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hainan General Hospital, Haikou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Chinese Medicine Centre for Training and Research, Yan Chai Hospital cum Hong Kong Baptist University (Yan Chai), Hongkong, China.'}, {'ForeName': 'Xiaokai', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Huizhou Third People's Hospital, Guangzhou Medical University, Huizhou, China.""}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Ou', 'Affiliation': 'Department of Big Data Research of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jiangshan', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Baile', 'Initials': 'B', 'LastName': 'Ning', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Pain,['10.1097/j.pain.0000000000002071']
3221,32947549,Restricted Convalescence Following Urogynecologic Procedures: 1-Year Outcomes From a Randomized Controlled Study.,"OBJECTIVE


To assess the relationship between postoperative activity recommendations and satisfaction and anatomic and functional outcomes 1 year after surgery for symptomatic prolapse.
METHODS


This is a planned secondary analysis reporting 1-year functional and anatomic outcomes of a multicenter, randomized, double-masked clinical trial ""ReCOUP."" In the original trial, women undergoing surgery for prolapse were randomized to liberal (no limitations on physical activity) or restricted (heavy lifting and high-impact activity prohibited) postoperative activity recommendations for 3 months after surgery. At 1 year, our primary outcome was satisfaction, assessed using a 5-point Likert scale answer to the question, ""How satisfied are you with the result of your prolapse surgery?"" Anatomic surgical failure was met if women had prolapse beyond the hymen, apical descent greater than one third the vaginal length, OR retreatment for prolapse.
RESULTS


Of the 95 women (n = 45 liberal, n = 50 restricted) who were randomized and completed primary 3-month outcomes, 83 (87%) completed a functional assessment, and 77 (81%) completed both functional and anatomic assessment at 1 year. Satisfaction with surgery remained high (91.5%) with no differences between groups (86.8% vs 95.6% P = 0.155) as did anatomic and functional outcomes. There were 7.8% women who met criteria for anatomic surgical failure with no difference between the restricted (7.0%) and liberal group (8.8%). Three women (2 in the restricted group, 1 in the liberal group) with recurrent prolapse and underwent surgery.
CONCLUSIONS


There were no significant differences in anatomic and functional outcomes at 12 months after surgery in women who resume postoperative activity liberally and those who restrict postoperative activity.",2020,Satisfaction with surgery remained high (91.5%) with no differences between groups (86.8% vs 95.6% P = 0.155) as did anatomic and functional outcomes.,"['women undergoing surgery for prolapse', 'Three women (2 in the restricted group, 1 in the liberal group) with recurrent prolapse and underwent surgery', '95 women (n = 45 liberal, n = 50 restricted) who were randomized and completed primary 3-month outcomes, 83 (87%) completed a functional assessment, and 77 (81%) completed both functional and anatomic assessment at 1 year']","['liberal (no limitations on physical activity) or restricted (heavy lifting and high-impact activity prohibited) postoperative activity recommendations', 'Urogynecologic Procedures']","['5-point Likert scale answer to the question, ""How satisfied are you with the result of your prolapse surgery', 'Anatomic surgical failure', 'anatomic and functional outcomes', 'anatomic surgical failure']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",95.0,0.36511,Satisfaction with surgery remained high (91.5%) with no differences between groups (86.8% vs 95.6% P = 0.155) as did anatomic and functional outcomes.,"[{'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'Mueller', 'Affiliation': 'From the Division of Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics and Gynecology and Urology, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lewicky-Gaupp', 'Affiliation': ''}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Tavathia', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kenton', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000922']
3222,32947603,Exploratory studies from the PiPS trial fail to find evidence that Bifidobacterium breve BBG-001 modifies intestinal barrier function.,"BACKGROUND


Uncertainty remains about the role of probiotics to prevent necrotising enterocolitis (NEC) some of which arises from the variety of probiotic interventions used in different trials, many with no prior evidence of potential efficacy. Mechanistic studies of intestinal barrier function embedded in a large probiotic trial could provide evidence about which properties of probiotics might be important for NEC prevention thus facilitating identification of strains with therapeutic potential.
METHODS


Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation were assessed from the second postnatal week in babies enrolled to a randomised controlled trial of B. breve BBG-001 (the PiPS trial). Results were compared by allocation and by stool colonisation with the probiotic.
RESULTS


Ninety-four preterm babies were recruited across six nested studies. B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation. No measure of intestinal barrier function showed differences. The PiPS trial found no evidence of efficacy to reduce NEC.
CONCLUSIONS


That the negative results of the PiPS trial were associated with failure of this probiotic to modify intestinal barrier function supports the possibility that the tests described here have the potential to identify strains to progress to large clinical trials.
IMPACT


Uncertainty about the therapeutic role of probiotics to prevent necrotising enterocolitis is in part due to the wide range of bacterial strains with no previous evidence of efficacy used in clinical trials.We hypothesised that mechanistic studies embedded in a probiotic trial would provide evidence about which properties of probiotics might be important for NEC prevention.The finding that the probiotic strain tested, Bifidobacterium breve BBG-001, showed neither effects on intestinal barrier function nor clinical efficacy supports the possibility that these tests have the potential to identify strains to progress to large clinical trials.Fig. 1FOETAL INTESTINE: THE INTESTINAL LUMEN (A) IN THE FOETUS IS STERILE; INTESTINAL MUCUS (B) IS WATERY; TLR4 RECEPTORS (C) ARE ABUNDANTLY EXPRESSED ON ENTEROCYTES; LARGE PROTEINS FROM AMNIOTIC FLUID (D) ARE EASILY ABSORBED BETWEEN WIDELY SPACED ENTEROCYTES (E) AND ENTER THE CIRCULATION (F).: Preterm neonatal intestine: the intestinal lumen (A) contains a higher proportion of potentially pathogenic (purple) than beneficial (green) bacteria; intestinal mucus is more abundant but still watery (B); potentially pathogenic bacteria are in close proximity to TLR4 receptors (C); in the absence of food, the intercellular gap remains wide (D); fluctuations in intestinal blood flow produces vasodilating substances (e.g. nitric oxide) (E). Necrotising enterocolitis: potentially pathogenic bacteria (purple) outnumber other bacteria in the intestinal lumen (A); intestinal mucus (B) may be interrupted allowing some bacteria to adhere to TLR4 receptors (C); activation of TLR4 leads to downstream production of IL8 through the NF-κB pathway (D) initiating further inflammation; bacterial translocation occurs through (E) and between (F) enterocytes into the systemic circulation.",2020,B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation.,"['Ninety-four preterm babies', 'Necrotising enterocolitis']",['Bifidobacterium breve'],"['intestinal barrier function', 'Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation', 'acetic acid levels']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]","[{'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",94.0,0.042855,B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fleming', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK. Paulfleming1@nhs.net.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilks', 'Affiliation': 'Department of Infection, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Panton', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hutchinson', 'Affiliation': 'Centre for Genomics and Child Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Abena', 'Initials': 'A', 'LastName': 'Akyempon', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Millar', 'Affiliation': 'Department of Infection, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Costeloe', 'Affiliation': 'Homerton University Hospital, NHS Foundation Trust, London, UK.'}]",Pediatric research,['10.1038/s41390-020-01135-5']
3223,32947839,Impact of Anticholinergic Medication Burden on Mobility and Falls in the Lifestyle Interventions for Elders (LIFE) Study.,"Anticholinergic cognitive burden (ACB) may be associated with detrimental effects on mobility and physical independence in older adults. We evaluated the incidence of major mobility disability (MMD), persistent major mobility disability (PMMD), and injurious falls among participants within the Lifestyle Interventions for Elders (LIFE) trial according to varied anticholinergic burden levels. Participants aged 70-89 years were randomized to a physical activity (PA) or successful aging (SA) intervention and evaluated by ACB medication use as a summed score of a previously developed ACB scale. Confounders included demographic characteristics, physical function, cognitive function, and fall history. Average participant follow-up was 2.6 years and included outcome assessment for MMD, PMMD, and injurious falls every six months. Adjusted proportional hazards models evaluated the independent effects of ACB scores as well as interaction effects with the intervention. Of the 1635 participants, 986 (60%) used ≥1 anticholinergic medication. Compared to those with no burden, participants with an ACB score of 1 demonstrated increased MMD (HR = 1.42 [1.13-1.78]), PMMD (HR = 1.53 [1.12-2.09]), and injurious falls (HR = 1.60 [1.10-2.32]). Results similar in magnitude were observed for all other ACB levels versus the no burden group. Stepwise dose-response comparisons between ACB groupings did not demonstrate significant differences in outcomes. Stratification by PA or SA interventions demonstrated few differences from the combined overall trial results. Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls. Total anticholinergic burden was not associated with a stepwise dose-response relationship in mobility disability and may lack sensitivity to capture varied responses.",2020,"Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls.","['older adults', 'Elders (LIFE) Study', 'Participants aged 70-89 years', '1635 participants, 986 (60%) used ≥1 anticholinergic medication']","['physical activity (PA) or successful aging (SA) intervention and evaluated by ACB medication', 'Anticholinergic cognitive burden (ACB']","['ACB levels', 'incidence of major mobility disability (MMD), persistent major mobility disability (PMMD), and injurious falls', 'demographic characteristics, physical function, cognitive function, and fall history', 'mobility and physical independence', 'MMD, PMMD, and injurious falls every six months', 'injurious falls', 'risk of MMD, PMMD, and injurious falls', 'Mobility and Falls', 'PMMD', 'MMD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1635.0,0.0385836,"Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Squires', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida College of Medicine, Gainesville, FL 32610, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida College of Medicine, Gainesville, FL 32610, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Vouri', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Brown', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}]",Journal of clinical medicine,['10.3390/jcm9092989']
3224,32947920,"The Influence of Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet on Body Composition, Strength, and Endurance Performance in Healthy Young Males: A Randomized Controlled Trial.","(1) Background: The influence of ketogenic diet on physical fitness remains controversial. We performed a randomized controlled trial to compare the effect of cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD) on body composition, muscle strength, and endurance performance. (2) Methods: 25 healthy young males undergoing regular resistance training combined with aerobic training were randomized to CKD ( n  = 13) or RD ( n  = 12). Body composition, muscle strength and spiroergometric parameters were measured at baseline and after eight weeks of intervention. (3) Results: Both CKD and RD decreased body weight, body fat, and BMI. Lean body mass and body water decreased in CKD and did not significantly change in RD group. Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased. Similarly, endurance performance was not changed in CKD group while in RD group peak workload and peak oxygen uptake increased. (4) Conclusions: Our data show that in healthy young males undergoing resistance and aerobic training comparable weight reduction were achieved by CKD and RD. In RD group; improved muscle strength and endurance performance was noted relative to neutral effect of CKD that also slightly reduced lean body mass.",2020,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"['25 healthy young males undergoing', 'Healthy Young Males', 'healthy young males']","['Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet', 'regular resistance training combined with aerobic training', 'cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD', 'ketogenic diet', 'CKD']","['Body Composition, Strength, and Endurance Performance', 'Body composition, muscle strength and spiroergometric parameters', 'peak workload and peak oxygen uptake', 'lean body mass', 'Muscle strength parameters', 'weight reduction', 'endurance performance', 'muscle strength and endurance performance', 'body composition, muscle strength, and endurance performance', 'Lean body mass and body water decreased in CKD', 'body weight, body fat, and BMI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005909', 'cui_str': 'Body water'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",25.0,0.026568,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Kysel', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Haluzíková', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Radka Petráková', 'Initials': 'RP', 'LastName': 'Doležalová', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Laňková', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeňka', 'Initials': 'Z', 'LastName': 'Lacinová', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Barbora Judita', 'Initials': 'BJ', 'LastName': 'Kasperová', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Jaroslava', 'Initials': 'J', 'LastName': 'Trnovská', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Viktorie', 'Initials': 'V', 'LastName': 'Hrádková', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Mráz', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeněk', 'Initials': 'Z', 'LastName': 'Vilikus', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}]",Nutrients,['10.3390/nu12092832']
3225,32947959,Unimanual Intensive Therapy with or without Unaffected Hand Containment in Children with Hemiplegia. A Randomized Controlled Pilot Study.,"Children with hemiplegia have lower spontaneous use and quality of movement in the affected upper limb. The modified constraint-induced movement therapy (mCIMT) is applied to improve the affected upper limb function. The objective of this study was to study the efficacy of unaffected hand containment to obtain changes in the function of the affected upper limb after applying two unimanual therapies. A randomized controlled pilot study was performed with 16 children diagnosed with congenital infantile hemiplegia, with eight children randomized in each group (average age: 5.54 years; SD: 1.55). mCIMT and unimanual therapy without containment (UTWC) were applied, with a total of 50 h distributed in five weeks (two h/per day). Two assessments were performed (pre- and post-treatment) to evaluate the affected upper limb spontaneous use, measured with the Shiners Hospital Upper Extremity Evaluation (SHUEE), and the quality of movement, measured with the Quality of Upper Extremity Skills Test (QUEST scale). The progression of the variables was different in both groups. The results are expressed in the median of the improvement percent and interquartile range (IQR). The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group. The quality of movement increased in the mCIMT and UTWC groups, 24.21 (IQR: 13.44, 50.39), 1.34 (IQR: 0.00, 4.75), respectively and the greatest increase was obtained in the grasp variable for both groups. The use of unaffected hand containment in mCIMT would produce improvements in the affected upper limb functionality in children with hemiplegia (4-8 years old) compared to the same protocol without containment (UTWC).",2020,"The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group.","['Children with Hemiplegia', 'Children with hemiplegia', 'children with hemiplegia (4-8 years old', '16 children diagnosed with congenital infantile hemiplegia, with eight children randomized in each group (average age: 5.54 years; SD: 1.55']","['modified constraint-induced movement therapy (mCIMT', 'mCIMT and unimanual therapy without containment (UTWC']","['interquartile range (IQR', 'quality of movement', 'Shiners Hospital Upper Extremity Evaluation (SHUEE), and the quality of movement, measured with the Quality of Upper Extremity Skills Test (QUEST scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0392550', 'cui_str': 'Infantile hemiplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0524540', 'cui_str': 'Shiner'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",16.0,0.0368662,"The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group.","[{'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursery, Physiotherapy and Podiatry, University of Seville, 49001 Seville, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ando-LaFuente', 'Affiliation': 'Physiotherapy Research Group in Toledo, GIFTO, 45071 Toledo, Spain.'}, {'ForeName': 'Asunción', 'Initials': 'A', 'LastName': 'Ferri-Morales', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bravo-Esteban', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Romay-Barrero', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9092992']
3226,32949456,Tailored exercise and home hazard reduction for fall prevention in older people with cognitive impairment: the i-FOCIS randomized controlled trial.,"BACKGROUND


The evidence to support effective fall prevention strategies in older people with cognitive impairment (CI) is limited. The aim of this randomized controlled trial (RCT) was to determine the efficacy of a fall prevention intervention in older people with CI.
METHODS


RCT involving 309 community-dwelling older people with CI. The intervention group (n=153) received an individually prescribed home hazard reduction and home-based exercise program during the 12-month study period. The control group (n=156) received usual care. The primary outcome was rate of falls. Secondary outcomes included faller/multiple faller status, physical function and quality of life.
RESULTS


Participants' average age was 82 years (95%CI 82-83) and 49% were female. There was no significant difference in the rate of falls (IRR 1.05 95%CI 0.73-1.51). A sensitivity analysis, controlling for baseline differences and capping the number of falls at 12 (four participants), revealed a non-significant reduction in fall rate in the intervention group (IRR 0.78 95%CI 0.57-1.07). Analyses of secondary outcomes indicated the intervention significantly reduced the number of multiple fallers by 26% (RR 0.74 95%CI 0.54-0.99) when adjusting for baseline differences. There was a differential impact on falls in relation to physical function (interaction term p-value=0.023) with a significant reduction in fall rate in intervention group participants with better baseline physical function (IRR 0.60 95%CI 0.37-0.98). There were no significant between group differences for other secondary outcomes.
CONCLUSIONS


This intervention did not significantly reduce the fall rate in community-dwelling older people with CI. The intervention did reduce the fall rate in participants with better baseline physical function.Trial registration: Australian and New Zealand Trials Registry ACTRN12614000603617.",2020,There was a differential impact on falls in relation to physical function (interaction term p-value=0.023) with a significant reduction in fall rate in intervention group participants with better baseline physical function (IRR 0.60 95%CI 0.37-0.98).,"['older people with CI', '309 community-dwelling older people with CI', 'older people with cognitive impairment', 'older people with cognitive impairment (CI', ""Participants' average age was 82 years (95%CI 82-83) and 49% were female""]","['fall prevention intervention', 'usual care', 'Tailored exercise and home hazard reduction', 'individually prescribed home hazard reduction and home-based exercise program']","['fall rate', 'number of multiple fallers', 'faller/multiple faller status, physical function and quality of life', 'rate of falls']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",309.0,0.180002,There was a differential impact on falls in relation to physical function (interaction term p-value=0.023) with a significant reduction in fall rate in intervention group participants with better baseline physical function (IRR 0.60 95%CI 0.37-0.98).,"[{'ForeName': 'Morag E', 'Initials': 'ME', 'LastName': 'Taylor', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Wesson', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, University of Sydney and Sydney Local health District, Sydney, NSW, Australia.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Rehabilitation Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kurrle', 'Affiliation': 'Department of Rehabilitation and Aged Care, Hornsby Ku-ring-gai Hospital, Hornsby, NSW, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Brodaty', 'Affiliation': 'Centre for Healthy Brain Ageing, School of Psychiatry, Faculty of Medicine, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': ""O'Rourke"", 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Payne', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Toson', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Lyndell', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Savage', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Zelma', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Cecelia', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Department of Rehabilitation and Aged Care, Hornsby Ku-ring-gai Hospital, Hornsby, NSW, Australia.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Lockwood', 'Affiliation': 'Department of Rehabilitation and Aged Care, Hornsby Ku-ring-gai Hospital, Hornsby, NSW, Australia.'}, {'ForeName': 'Jacqueline C T', 'Initials': 'JCT', 'LastName': 'Close', 'Affiliation': 'Neuroscience Research Australia, UNSW Sydney, Randwick, NSW, Australia.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa241']
3227,32949500,"Intravesical bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomised, placebo-controlled, double-blind clinical trial.","BACKGROUND


Urinary tract infections (UTIs) are among the most prevalent microbial diseases and their financial burden on society is substantial. In the context of increasing antibiotic resistance, finding alternative treatments for UTIs is a top priority. We aimed to determine whether intravesical bacteriophage therapy with a commercial bacteriophage cocktail is effective in treating UTI.
METHODS


We did a randomised, placebo-controlled, clinical trial, at the Alexander Tsulukidze National Centre of Urology, Tbilisi, Georgia. Men older than 18 years of age, who were scheduled for transurethral resection of the prostate (TURP), with complicated UTI or recurrent uncomplicated UTI but no signs of systemic infection, were allocated by block randomisation in a 1:1:1 ratio to receive intravesical Pyo bacteriophage (Pyophage; 20 mL) or intravesical placebo solution (20 mL) in a double-blind manner twice daily for 7 days, or systemically applied antibiotics (according to sensitivities) as an open-label standard-of-care comparator. Urine culture was taken via urinary catheter at the end of treatment (ie, day 7) or at withdrawal from the trial. The primary outcome was microbiological treatment response after 7 days of treatment, measured by urine culture; secondary outcomes included clinical and safety parameters during the treatment period. Analyses were done in a modified intention-to-treat population of patients having received at least one dose of the allocated treatment regimen. This trial is registered with ClinicalTrials.gov, NCT03140085.
FINDINGS


Between June 2, 2017, and Dec 14, 2018, 474 patients were screened for eligibility and 113 (24%) patients were randomly assigned to treatment (37 to Pyophage, 38 to placebo, and 38 to antibiotic treatment). 97 patients (28 Pyophage, 32 placebo, 37 antibiotics) received at least one dose of their allocated treatment and were included in the primary analysis. Treatment success rates did not differ between groups. Normalisation of urine culture was achieved in five (18%) of 28 patients in the Pyophage group compared with nine (28%) of 32 patients in the placebo group (odds ratio [OR] 1·60 [95% CI 0·45-5·71]; p=0·47) and 13 (35%) of 37 patients in the antibiotic group (2·66 [0·79-8·82]; p=0·11). Adverse events occurred in six (21%) of 28 patients in the Pyophage group compared with 13 (41%) of 32 patients in the placebo group (OR 0·36 [95% CI 0·11-1·17]; p=0·089) and 11 (30%) of 37 patients in the antibiotic group (0·66 [0·21-2·07]; p=0·47).
INTERPRETATION


Intravesical bacteriophage therapy was non-inferior to standard-of-care antibiotic treatment, but was not superior to placebo bladder irrigation, in terms of efficacy or safety in treating UTIs in patients undergoing TURP. Moreover, the bacteriophage safety profile seems to be favourable. Although bacteriophages are not yet a recognised or approved treatment option for UTIs, this trial provides new insight to optimise the design of further large-scale clinical studies to define the role of bacteriophages in UTI treatment.
FUNDING


Swiss Continence Foundation, the Swiss National Science Foundation, and the Swiss Agency for Development and Cooperation.
TRANSLATIONS


For the Georgian and German translations of the abstract see Supplementary Materials section.",2020,Treatment success rates did not differ between groups.,"['97 patients (28 Pyophage, 32 placebo, 37 antibiotics', 'Between June 2, 2017, and Dec 14, 2018, 474 patients were screened for eligibility and 113 (24%) patients', 'patients undergoing transurethral resection of the prostate', 'patients undergoing TURP', 'Men older than 18 years of age, who were scheduled for transurethral resection of the prostate (TURP), with complicated UTI or recurrent uncomplicated UTI but no signs of systemic infection']","['placebo bladder irrigation', 'placebo', 'Intravesical bacteriophages', 'intravesical Pyo bacteriophage (Pyophage; 20 mL) or intravesical placebo solution (20 mL) in a double-blind manner twice daily for 7 days, or systemically applied antibiotics (according to sensitivities) as an open-label standard-of-care comparator']","['Adverse events', 'microbiological treatment response after 7 days of treatment, measured by urine culture; secondary outcomes included clinical and safety parameters', 'Normalisation of urine culture', 'Treatment success rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0004651', 'cui_str': 'Bacterial virus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0194423', 'cui_str': 'Irrigation of urinary bladder'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0004651', 'cui_str': 'Bacterial virus'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430404', 'cui_str': 'Urine culture'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",474.0,0.589573,Treatment success rates did not differ between groups.,"[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Aleksandre', 'Initials': 'A', 'LastName': 'Ujmajuridze', 'Affiliation': 'Alexander Tsulukidze National Centre of Urology, Tbilisi, Georgia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Chanishvili', 'Affiliation': 'Eliava Institute of Bacteriophage, Microbiology, and Virology, Tbilisi, Georgia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Goderdzishvili', 'Affiliation': 'Eliava Institute of Bacteriophage, Microbiology, and Virology, Tbilisi, Georgia.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Chkonia', 'Affiliation': 'Eliava Institute of Bacteriophage, Microbiology, and Virology, Tbilisi, Georgia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Rigvava', 'Affiliation': 'Eliava Institute of Bacteriophage, Microbiology, and Virology, Tbilisi, Georgia.'}, {'ForeName': 'Archil', 'Initials': 'A', 'LastName': 'Chkhotua', 'Affiliation': 'Alexander Tsulukidze National Centre of Urology, Tbilisi, Georgia.'}, {'ForeName': 'Giorgi', 'Initials': 'G', 'LastName': 'Changashvili', 'Affiliation': 'Alexander Tsulukidze National Centre of Urology, Tbilisi, Georgia.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'McCallin', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland; Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Schneider', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Wilbert', 'Initials': 'W', 'LastName': 'Sybesma', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland; Yoba for Life Foundation, Amsterdam, Netherlands.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. Electronic address: tkessler@gmx.ch.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30330-3']
3228,32949505,Effect of permanent right internal mammary artery occlusion on right coronary artery supply: A randomized placebo-controlled clinical trial.,"BACKGROUND


Natural, non-surgical internal mammary artery (IMA) bypasses to the coronary circulation have been shown to function as extracardiac sources of myocardial blood supply. The goal of this randomized, placebo-controlled, double blind trial was to test the efficacy of permanent right IMA (RIMA) device occlusion on right coronary artery (RCA) occlusive blood supply, and on clinical and ECG signs of myocardial ischemia.
METHODS


This was a prospective superiority trial in 100 patients with chronic coronary artery disease (CAD) randomly allocated (1:1) to RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo group). The primary study endpoint was RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion at baseline before and at follow-up exam 6weeks after the trial intervention. CFI is the ratio between simultaneous mean coronary occlusive divided by mean aortic pressure both subtracted by central venous pressure. Simultaneously obtained secondary study endpoints were the registration of angina pectoris and quantitative intracoronary (i.c.) ECG ST-segment shift.
RESULTS


CFI change during the follow-up period was +0.036±0.068 in the verum group and-0.021±0.097 in the placebo group (P=.0011). Angina pectoris during the same RCA balloon occlusions had disappeared at follow-up in 14/49 patients of the verum group, and in 4/49 patients of the placebo group (P=.0091). Simultaneous i.c. ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
CONCLUSION


Permanent RIMA device occlusion augments right coronary artery supply to the effect of diminishing clinical and electrocardiographic signs of myocardial ischemia during a brief controlled coronary occlusion.",2020,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
",['100 patients with chronic coronary artery disease (CAD) randomly allocated (1:1) to'],"['permanent right internal mammary artery occlusion', 'permanent right IMA (RIMA) device occlusion', 'placebo', 'RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo', 'CFI']","['right coronary artery supply', 'registration of angina pectoris and quantitative intracoronary (i.c', 'myocardial ischemia', 'Angina pectoris', 'RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion', 'CFI change', 'severe ischemia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0500531', 'cui_str': 'Right internal mammary artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1608397', 'cui_str': 'Device occlusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4552248', 'cui_str': 'Vascular device occlusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",100.0,0.210404,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
","[{'ForeName': 'Marius R', 'Initials': 'MR', 'LastName': 'Bigler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stoller', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tschannen', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Grossenbacher', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seiler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland. Electronic address: christian.seiler@insel.ch.'}]",American heart journal,['10.1016/j.ahj.2020.09.006']
3229,32949542,"Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial.","BACKGROUND


Many patients who require migraine preventive treatment have not been able to tolerate or have not responded to multiple previous preventive medications. We aimed to assess the safety and efficacy of galcanezumab, an antibody to calcitonin gene-related peptide, in patients with migraine who had not benefited from preventive medications from two to four categories.
METHODS


CONQUER was a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial done at 64 sites (hospitals, clinics, or research centres) in 12 countries (Belgium, Canada, Czech Republic, France, Germany, Hungary, Japan, the Netherlands, South Korea, Spain, the UK, and the USA). Patients were 18-75 years of age, with episodic or chronic migraine, with migraine onset before the age of 50 years, who had a documented failure of preventive medications from two to four drug categories in the past 10 years owing to lack of efficacy or tolerability, or both. Patients were randomised 1:1 to receive subcutaneous placebo or galcanezumab 120 mg per month (with a 240 mg loading dose administered as two 120 mg injections) for 3 months. For masking purposes, patients receiving placebo also received two injections during the first dosing visit. Randomisation was done by a computer-generated random sequence by means of an interactive web-response system stratified by country and migraine frequency (low frequency episodic migraine, four to fewer than eight migraine headache days per month; high frequency episodic migraine, eight to 14 migraine headache days per month and fewer than 15 headache days per month; chronic migraine, at least eight migraine headache days per month and at least 15 headache days per month). The primary endpoint was the overall mean change from baseline in number of monthly migraine headache days during the 3-month treatment period in all patients who were randomly assigned and received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT03559257, and is now completed.
FINDINGS


Between Sept 10, 2018, and March 21, 2019, 462 participants with episodic (269 [58%]) or chronic (193 [42%]) migraine were randomly assigned and received at least one injection with placebo (n=230) or galcanezumab (n=232). Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo across months 1-3. The galcanezumab group had on average 4·1 fewer monthly migraine headache days compared with baseline (13·4), while the placebo group had on average 1·0 fewer than at baseline (13·0; between-group difference -3·1 [95% CI -3·9 to -2·3]; p<0·0001; effect size=0·72). Types and number of treatment-emergent adverse events were similar between galcanezumab and placebo. Treatment-emergent adverse events were reported in 122 (53%) of 230 patients in the placebo group and 119 (51%) of 232 patients in the galcanezumab group. There were four serious adverse events during the study, two (1%) reported in the placebo group and two (1%) reported in the galcanezumab group.
INTERPRETATION


Galcanezumab was superior to placebo in the preventive treatment of migraine and was safe and well tolerated in patients for whom multiple previous standard-of-care preventive treatments had failed. Galcanezumab might represent an important treatment option for patients who have not benefited from or tolerated previous standard-of-care treatments.
FUNDING


Eli Lilly.",2020,Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo across months 1-3.,"['patients with migraine who had not benefited from preventive medications from two to four categories', 'Between Sept 10, 2018, and March 21, 2019, 462 participants with episodic (269 [58%]) or chronic (193 [42%]) migraine', '64 sites (hospitals, clinics, or research centres) in 12 countries (Belgium, Canada, Czech Republic, France, Germany, Hungary, Japan, the Netherlands, South Korea, Spain, the UK, and the USA', 'Patients were 18-75 years of age, with episodic or chronic migraine, with migraine onset before the age of 50 years, who had a documented failure of preventive medications from two to four drug categories in the past 10 years owing to lack of efficacy or tolerability, or both', 'patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER', 'patients who have not benefited from or tolerated previous standard-of-care treatments']","['galcanezumab and placebo', 'galcanezumab', 'Galcanezumab', 'placebo', 'subcutaneous placebo or galcanezumab']","['overall mean change from baseline in number of monthly migraine headache days', 'Safety and efficacy', 'safety and efficacy', 'migraine headache days', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",462.0,0.540374,Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo across months 1-3.,"[{'ForeName': 'Wim M', 'Initials': 'WM', 'LastName': 'Mulleners', 'Affiliation': 'Neurology Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Byung-Kun', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Neurology Department, Nowon Eulji Medical Center, Seoul, South Korea.'}, {'ForeName': 'Miguel J A', 'Initials': 'MJA', 'LastName': 'Láinez', 'Affiliation': 'Hospital Clínico Universitario, Universidad Católica de Valencia, Valencia, Spain.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lanteri-Minet', 'Affiliation': 'Pain Department CHU Nice and FHU InovPain Côte Azur University, Nice, France; INSERM/UdA, U1107, Neuro-Dol, Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pozo-Rosich', 'Affiliation': ""Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Headache Research Group, Vall d'Hebron Institute of Research, Department de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': 'Eli Lilly, Windlesham, Surrey, UK.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Impel NeuroPharma, Seattle, WA, USA.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Nichols', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Yunes-Medina', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Holland C', 'Initials': 'HC', 'LastName': 'Detke', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA. Electronic address: detke_holland_c@lilly.com.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30279-9']
3230,32949991,Motor imagery combined with action observation training optimized for individual motor skills further improves motor skills close to a plateau.,"The acquisition of high-level motor skills beyond a ""plateau"" is important in sports training and rehabilitation. We aimed to investigate whether motor skills close to a plateau state can be improved further by performing motor imagery (MI) training while observing movements with difficulty levels optimized for individual motor skills. The subjects were divided randomly into four groups (n = 10 per group): the control group and three groups of MI combined with action observation (MI + AO) training with varying difficulty levels. The task was to rotate the two cork balls 20 times counterclockwise using the left hand. The subjects performed 30 and 10 successful trials of this task before and after MI + AO training, respectively. In the three training groups, MI training was performed while observing videos showing ball rotation movements adjusted to the same level, a moderately higher level, or a remarkably higher level of difficulty than that achieved by the individual subjects. The improvement rate of the ball rotation time after MI + AO training was significantly higher in the moderate-difficulty than in the control group and remarkably higher level of difficulty group. The other two MI + AO training groups did not differ significantly compared with the control group. The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group. These results suggest that performing MI training while observing movement at a level that is moderately higher than an individual's ability can promote improvements in motor skills (close to a plateau state) in rehabilitation and sports training. The vividness of MI may be an important index for determining the difficulty level of the movement to be observed during MI + AO training.",2020,The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group.,[],"['MI training', 'MI combined with action observation (MI\xa0+\xa0AO) training with varying difficulty levels', 'Motor imagery combined with action observation training', 'motor imagery (MI) training']","['motor skills', 'vividness of the MI during MI\xa0+\xa0AO training', 'motor skills close', 'improvement rate of the ball rotation time after MI\xa0+\xa0AO training']",[],"[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0112839,The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group.,"[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences, 4669-2 Ami, Ami-Machi, Inashiki-gun, Ibaraki, Japan. Electronic address: aoyamato@ipu.ac.jp.'}, {'ForeName': 'Fuminari', 'Initials': 'F', 'LastName': 'Kaneko', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan. Electronic address: f-kaneko@keio.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kohno', 'Affiliation': 'Centre for Medical Sciences, Ibaraki Prefectural University of Health Sciences, 4669-2 Ami, Ami-Machi, Inashiki-gun, Ibaraki, Japan. Electronic address: kohno@ipu.ac.jp.'}]",Human movement science,['10.1016/j.humov.2020.102683']
3231,32950036,Efficacy of Circumferential Intensive Phototherapy in Treating Neonatal Hyperbilirubinemia: A Pilot Study.,"OBJECTIVE


The present study was aimed at developing a circumferential phototherapy unit using 3M reflective materials in the double-sided phototherapy unit and investigating its efficacy in treating neonatal hyperbilirubinemia.
STUDY DESIGN


Forty-two infants with neonatal hyperbilirubinemia were selected from our hospital; they were randomly divided into control ( n  = 21) and experimental groups ( n  = 21). The experimental group was treated with the circumferential phototherapy unit, while the control group was treated with an ordinary phototherapy unit.
RESULTS


No significant differences were noted between the two groups in the levels of transcutaneous bilirubin before phototherapy ( p  > 0.05). After 12 hours of phototherapy, the value of transcutaneous bilirubin decreased significantly in the experimental group compared with that of the control group ( p  < 0.05). Additionally, the two groups did not exhibit any significant difference in the side effects ( p  > 0.05).
CONCLUSION


Our results indicated that the circumferential phototherapy unit was more effective than the ordinary phototherapy unit in treating neonatal hyperbilirubinemia.
KEY POINTS


· A circumferential phototherapy unit was developed using 3M reflective materials.. · The circumferential phototherapy unit was more effective than the ordinary.. · The two groups did not exhibit any significant difference in the side effects..",2020,No significant differences were noted between the two groups in the levels of transcutaneous bilirubin before phototherapy ( p  > 0.05).,"['Forty-two infants with neonatal hyperbilirubinemia were selected from our hospital', 'Treating Neonatal Hyperbilirubinemia']","['Circumferential Intensive Phototherapy', 'circumferential phototherapy unit, while the control group was treated with an ordinary phototherapy unit']","['levels of transcutaneous bilirubin', 'value of transcutaneous bilirubin', 'side effects']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0182261', 'cui_str': 'Phototherapy unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",42.0,0.0149103,No significant differences were noted between the two groups in the levels of transcutaneous bilirubin before phototherapy ( p  > 0.05).,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}, {'ForeName': 'Weinong', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': ""Neonatal Intensive Care Unit, Hangzhou Women's Hospital (Hangzhou Maternity and Child Health Care Hospital), Hangzhou, China.""}]",American journal of perinatology,['10.1055/s-0040-1717069']
3232,32947572,Mechanical Characteristics of Heavy vs. Light Load Ballistic Resistance Training in Older Adults.,"Rodriguez-Lopez, C, Alcazar, J, Sánchez-Martín, C, Ara, I, Csapo, R, and Alegre, LM. Mechanical characteristics in heavy vs. light load ballistic resistance training in older adults. J Strength Cond Res XX(X): 000-000, 2020-Although power-oriented resistance training (RT) is strongly recommended to counter age-related neuromuscular function declines, there is still controversy about which intensities of load should be used to elicit optimal training adaptations. Knowledge of the mechanical characteristics of power-oriented RT performed at different intensities might help to better understand the training stimulus that triggers load-dependent adaptations in older adults. Using a cross-over design, 15 well-functioning older volunteers (9 men and 6 women; 73.6 ± 3.8 years) completed 2 volume × load-matched ballistic RT sessions with heavy (HL: 6 × 6 × 80% 1-repetition maximum [1RM]) and light-load (LL: 6 × 12 × 40% 1RM) on a horizontal leg press exercise. Electromyographic (EMG) and mechanical variables (work, force, velocity, and power) as well as intraset neuromuscular fatigue (i.e., relative losses in force, velocity, and power) were analyzed. More concentric mechanical work was performed in the LL training session, compared with HL (36.2 ± 11.2%; p < 0.001). Despite the higher mean EMG activity of the quadriceps femoris muscle (13.2 ± 21.1%; p = 0.038) and greater concentric force (35.2 ± 7.6%; p < 0.001) during HL, higher concentric velocity (41.0 ± 12.7%, p < 0.001) and a trend toward higher concentric power (7.2 ± 18.9%, p = 0.075) were found for LL. Relative velocity losses were similar in both sessions (≈10%); however, relative force losses were only found in LL (7.4 ± 6.5%, p = 0.003). Considering the greater mechanical work performed and concentric power generated, ballistic RT using LL may, therefore, represent a stronger stimulus driving training adaptations as compared with volume × load-matched heavy-load training. Relative losses in force and power should be monitored in addition to velocity losses during ballistic RT.",2020,"Despite the higher mean EMG activity of the quadriceps femoris muscle (13.2 ± 21.1%; p = 0.038) and greater concentric force (35.2 ± 7.6%; p < 0.001) during HL, higher concentric velocity (41.0 ± 12.7%, p < 0.001) and a trend toward higher concentric power (7.2 ± 18.9%, p = 0.075) were found for LL.","['older adults', 'Older Adults', '15 well-functioning older volunteers (9 men and 6 women; 73.6 ± 3.8 years']","['completed 2 volume × load-matched ballistic RT sessions with heavy (HL: 6 × 6 × 80% 1-repetition maximum [1RM]) and light-load (LL: 6 × 12 × 40% 1RM', 'horizontal leg press exercise', 'J Strength Cond Res XX(X', 'heavy vs. light load ballistic resistance training', 'Mechanical Characteristics of Heavy vs. Light Load Ballistic Resistance Training', '2020-Although power-oriented resistance training (RT']","['concentric velocity', 'mean EMG activity of the quadriceps femoris muscle', 'Electromyographic (EMG) and mechanical variables (work, force, velocity, and power) as well as intraset neuromuscular fatigue (i.e., relative losses in force, velocity, and power', 'greater concentric force', 'Relative velocity losses', 'relative force losses']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",,0.0250637,"Despite the higher mean EMG activity of the quadriceps femoris muscle (13.2 ± 21.1%; p = 0.038) and greater concentric force (35.2 ± 7.6%; p < 0.001) during HL, higher concentric velocity (41.0 ± 12.7%, p < 0.001) and a trend toward higher concentric power (7.2 ± 18.9%, p = 0.075) were found for LL.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Lopez', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Alcazar', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Sánchez-Martín', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ara', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Csapo', 'Affiliation': 'Research Unit for Orthopaedic Sports Medicine and Injury Prevention, ISAG, University for Health Sciences, Medical Informatics and Technology, Hall, Austria.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Alegre', 'Affiliation': 'GENUD Toledo Research Group, Universidad de Castilla-La Mancha, Toledo, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003826']
3233,32948120,"Sing4Health: protocol of a randomized controlled trial of the effects of a singing group intervention on the well-being, cognitive function and health of older adults.","BACKGROUND


Singing is a multimodal activity that requires physical, cognitive and psychosocial performance, with benefits to various domains of well-being and health in older adults. In recent years, research has increasingly studied group singing as an important cost-effective intervention to promote active and healthy aging. However, the specific factors responsible for these benefits need further experimental support, as most studies do not allow for causal inferences. This study responds to the need for further randomized controlled trials (RCT), with follow-up measurement, on the benefits of group singing in older adults from a low socioeconomic background. Also, while most studies often focus on specific outcome measure dimensions, in this study, the conjoint effect of several physical, psychosocial, psychoemotional and cognitive dimensions are analyzed, testing mediation effects of psychosocial and psychoemotional variables on the well-being and health of the participants.
METHODS


We implement and measure the effects of a singing group program for older adults, with an RCT crossover design study, in a natural context, before and after the intervention and in a follow-up, 6 months after the intervention.
PARTICIPANTS


140 retired older adults (> 60 years) users of a social support institution, will be invited to participate in a singing group program and randomly allocated to an experimental (n = 70) and a control (n = 70) group, which will enroll in the regular activities proposed by the institution. The intervention consists of 34 bi-weekly group singing sessions, of 2 h each, for 4 months. Measures on social and emotional well-being, cognitive function, and health indicators (e.g., blood pressure, glycemia, cholesterol, c-reactive protein, sedimentation rate, respiratory function, body balance, sleep quality, medication intake, and health services attendance) will be collected. Interviews will be conducted on the motivation and perceived benefits of participation.
DISCUSSION


Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging. Psychosocial and psychoemotional variables are expected to be mediators of the effects of the program in the cognitive function, well-being and health of the participants.
TRIAL REGISTRATION


NCT03985917 . Registered 14th June 2019 (retrospectively registered).",2020,"DISCUSSION


Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging.","['older adults', '140 retired older adults (>\u200960\u2009years) users of a social support institution, will be invited to participate in a singing group program', 'older adults from a low socioeconomic background', 'healthy aging']","['singing group intervention', 'singing group program']","['social and emotional well-being, cognitive function, and health indicators (e.g., blood pressure, glycemia, cholesterol, c-reactive protein, sedimentation rate, respiratory function, body balance, sleep quality, medication intake, and health services attendance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0325504,"DISCUSSION


Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging.","[{'ForeName': 'Iolanda Costa', 'Initials': 'IC', 'LastName': 'Galinha', 'Affiliation': 'Centro de Investigação em Psicologia (CIP), da Universidade Autónoma de Lisboa / Universidade do Algarve, CIS-ISTE-IUL; APPSYCI, Rua de Santa Marta, 47, 3° (Room, 304), 1169-023, Lisbon, Portugal. igalinha@autonoma.pt.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Farinha', 'Affiliation': 'Centro de Investigação em Psicologia (CIP), da Universidade Autónoma de Lisboa / Universidade do Algarve from Rua de Santa Marta, 47, 3° (Room, 304), 1169-023, Lisbon, Portugal.'}, {'ForeName': 'Maria Luísa', 'Initials': 'ML', 'LastName': 'Lima', 'Affiliation': 'ISCTE CIS IUL, Av. das Forças Armadas, ISCTE-IUL building, 2w17 Room, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'António Labisa', 'Initials': 'AL', 'LastName': 'Palmeira', 'Affiliation': 'Universidade de Lisboa & Universidade Lusófona de Humanidades e Tecnologias, Campo Grande, 376, 1749-024, Lisbon, Portugal.'}]",BMC geriatrics,['10.1186/s12877-020-01686-6']
3234,32948138,Lower versus higher diagnostic criteria for the detection of gestational diabetes for reducing maternal and perinatal morbidity: study protocol for the GEMS randomised trial.,"BACKGROUND


Gestational diabetes mellitus (GDM) has lifelong implications for the woman and her infant. Treatment reduces adverse maternal and perinatal outcomes although uncertainty remains about the optimal diagnostic criteria. The GEMS Trial aims to assess whether detection and treatment of women with GDM using the lower International Association of Diabetes in Pregnancy Study Groups diagnostic criteria compared with the higher criteria recommended in New Zealand reduces infant morbidity without increasing maternal morbidity.
METHODS


GEMS is a multicentre, randomised trial. Women with a singleton pregnancy at 24 to 34 weeks' gestation are eligible who give written informed consent. Women are randomly allocated to the Lower Criteria Group or the Higher Criteria Group. Women with a normal OGTT by their allocated criteria receive routine care (Higher criteria: fasting plasma glucose < 5.5 mmol/L, AND 2 hour < 9.0 mmol/L; Lower criteria: fasting plasma glucose < 5.1 mmol/L, AND 1 hour < 10.0 mmol/L, AND 2 hour < 8.5 mmol/l). Women with GDM on OGTT by their allocated criteria receive standard care for GDM (Higher criteria: fasting plasma glucose ≥ 5.5 mmol/L, OR 2 hour ≥ 9.0 mmol/L; Lower criteria: fasting plasma glucose ≥ 5.1 mmol/L, OR 1 hour ≥ 10.0 mmol/L, OR 2 hour ≥ 8.5 mmol/L). The primary outcome is large for gestational age (birth weight > 90th centile). Secondary outcomes for the infant include a composite of serious outcomes, gestational age, anthropometry, Apgar score < 4 at 5 minutes, lung disease, use of respiratory support, hypoglycaemia, hyperbilirubinaemia, infection, and encephalopathy; and for the woman, a composite of serious outcomes, preeclampsia, induction of labour, mode of birth, weight gain, postpartum haemorrhage and infectious morbidity. A study with 4,158 women will detect an absolute difference of 2.9% in the proportion of large for gestational age infants from 10.0% using the lower criteria to 12.9% with the higher criteria.
DISCUSSION


The GEMS Trial will provide high-level evidence relevant for clinical practice. If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry registration number ACTRN12615000290594 . Date registered: 27th March 2015.",2020,"If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes.
","['Women with a normal OGTT by their allocated criteria receive', ""Women with a singleton pregnancy at 24 to 34 weeks' gestation are eligible who give written informed consent"", '4,158 women', 'Women with GDM on OGTT by their allocated criteria receive', 'women with GDM', 'Gestational diabetes mellitus (GDM']","['standard care for GDM (Higher criteria: fasting plasma glucose\u2009≥\u20095.5\xa0mmol/L, OR 2 hour', 'routine care (Higher criteria: fasting plasma glucose\u2009<\u20095.5\xa0mmol/L, AND 2 hour\u2009<\u20099.0\xa0mmol/L; Lower criteria: fasting plasma glucose\u2009<\u20095.1\xa0mmol/L, AND 1 hour\u2009<\u200910.0\xa0mmol/L, AND 2 hour\u2009<\u20098.5\xa0mmol/l']","['adverse maternal and perinatal outcomes', 'infant include a composite of serious outcomes, gestational age, anthropometry, Apgar score\u2009<\u20094\xa0at 5 minutes, lung disease, use of respiratory support, hypoglycaemia, hyperbilirubinaemia, infection, and encephalopathy; and for the woman, a composite of serious outcomes, preeclampsia, induction of labour, mode of birth, weight gain, postpartum haemorrhage and infectious morbidity', 'large for gestational age (birth weight\u2009>\u200990th centile']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",4158.0,0.156033,"If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes.
","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, The University of Auckland, Building 503, Level 2, 85 Park Road, Auckland Private Bag 92019, 1142, Auckland, New Zealand. c.crowther@auckland.ac.nz.'}, {'ForeName': 'Lesley M E', 'Initials': 'LME', 'LastName': 'McCowan', 'Affiliation': 'Department Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Rowan', 'Affiliation': ""Department of Obstetrics, National Women's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Edlin', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christopher J D', 'Initials': 'CJD', 'LastName': 'McKinlay', 'Affiliation': 'Liggins Institute, The University of Auckland, Building 503, Level 2, 85 Park Road, Auckland Private Bag 92019, 1142, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03252-9']
3235,32948178,Learning outcomes of a flipped classroom teaching approach in an adult-health nursing course: a quasi-experimental study.,"BACKGROUND


New teaching strategies must be developed not only to enhance nurse's competence but also to allow nurses to respond to the complex health care needs of today's society. The purpose of this study was to explore the learning outcomes of a flipped classroom teaching approach in an adult-health nursing course for students in a two-year Bachelor of Science in Nursing program.
METHODS


The study had a quasi-experimental design. An 18-week flipped classroom teaching approach was applied in an adult-health nursing course. In total, 485 nursing students enrolled in the study, with 287 in the experimental group and 198 in the control group. The Self-Evaluated Core Competencies Scale, Metacognitive Inventory for Nursing Students, Self-Directed Learning Readiness Scale, and self-designed learning satisfaction questionnaire were used to evaluate the students' learning outcomes.
RESULTS


The experimental group showed a statistically significant increase in the overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness; further, they also showed high levels of course satisfaction.
CONCLUSIONS


A flipped classroom teaching approach had a positive impact on student's learning motivation and contributed to better learning outcomes in an adult-health nursing course. The flipped classroom combined with hybrid teaching methods is a suitable and effective learning strategy for a registered nurse (RN) to Bachelor of Science in Nursing (BSN) program to tackle today's complex revolution in nursing curricula, and may enhance nursing students' abilities to address numerous challenges.",2020,"The experimental group showed a statistically significant increase in the overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness; further, they also showed high levels of course satisfaction.
","['adult-health nursing course for students in a two-year Bachelor of Science in Nursing program', '485 nursing students enrolled in the study, with 287 in the experimental group and 198 in the control group', 'adult-health nursing course']",['flipped classroom teaching approach'],"['Self-Evaluated Core Competencies Scale, Metacognitive Inventory for Nursing Students, Self-Directed Learning Readiness Scale, and self-designed learning satisfaction questionnaire', 'overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness', 'learning outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",485.0,0.0146476,"The experimental group showed a statistically significant increase in the overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness; further, they also showed high levels of course satisfaction.
","[{'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Fan', 'Affiliation': 'Department of Nursing & Graduate Institute of Nursing, Chang Gung University of Science and Technology, Division of Nursing, Chang Gung Memorial Hospital, Linkou Branch, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.). jyfan@gw.cgust.edu.tw.'}, {'ForeName': 'Ying-Jung', 'Initials': 'YJ', 'LastName': 'Tseng', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.).'}, {'ForeName': 'Li-Fen', 'Initials': 'LF', 'LastName': 'Chao', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.).'}, {'ForeName': 'Shiah-Lian', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, National Taichung University of Science and Technology, No.129, Sec. 3, Sanmin Rd., North Dist., Taichung City, 40401, Taiwan (R.O.C.).'}, {'ForeName': 'Sui-Whi', 'Initials': 'SW', 'LastName': 'Jane', 'Affiliation': 'Department of Nursing & Graduate Institute of Nursing, Chang Gung University of Science and Technology, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.).'}]",BMC medical education,['10.1186/s12909-020-02240-z']
3236,31982148,Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis.,"PURPOSE


Golimumab is a fully human monoclonal antibody to tumor necrosis factor-α and is indicated for the treatment of moderately to severely active ulcerative colitis (UC). This study analyzed the population pharmacokinetic (PK) properties of golimumab and exposure-response for efficacy and safety, using data from combined Phase II/III UC studies.
METHODS


Data on serum golimumab concentration following IV and subcutaneous (SC) administration were fitted simultaneously using nonlinear mixed-effects modeling for the development of a population PK model. Logistic regression models were used for assessing relationships between serum golimumab concentrations and clinical efficacy outcomes in SC induction and maintenance studies. The percentages of patients developing infections, serious infections, and serious adverse events were assessed by golimumab exposure metric quartiles.
FINDINGS


The PK properties of golimumab are well described by a 2-compartment model with first-order absorption and elimination. Typical values of PK parameters in a 70-kg patient were clearance, 0.544 L/d; central and peripheral compartment V d , 3.43 and 2.27 L, respectively; and intercompartmental clearance, 0.291 L/d. Golimumab t 1 /2  was 10.5 days; bioavailability following SC administration was 52.2%. Body weight, anti-golimumab antibodies, serum albumin, C-reactive protein, and alkaline phosphatase affected golimumab disposition. A positive exposure-response relationship was established between golimumab concentration and efficacy outcomes. No apparent correlation between golimumab exposure and rate of infections, serious infections, or serious adverse events was observed in patients receiving golimumab 50 or 100 mg SC every 4 weeks through 1 year.
IMPLICATIONS


Body weight, serum albumin, and anti-golimumab antibodies explain some of the variability observed in the PK properties of golimumab, and exposure-response findings support the recommended posology of golimumab in UC. ClinicalTrials.gov identifiers: NCT00488774, NCT00487539, and NCT00488631.",2020,"No apparent correlation between golimumab exposure and rate of infections, serious infections, or serious adverse events was observed in patients receiving golimumab 50 or 100 mg SC every 4 weeks through 1 year.
",['Adults'],['IV and subcutaneous (SC'],"['Typical values of PK parameters', 'percentages of patients developing infections, serious infections, and serious adverse events', 'Body weight, anti-golimumab antibodies, serum albumin,\xa0C-reactive protein, and alkaline phosphatase affected golimumab disposition', 'bioavailability', 'golimumab exposure and rate of infections, serious infections, or serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0656243,"No apparent correlation between golimumab exposure and rate of infections, serious infections, or serious adverse events was observed in patients receiving golimumab 50 or 100 mg SC every 4 weeks through 1 year.
","[{'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA, USA. Electronic address: oadedoku@its.jnj.com.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Liao', 'Affiliation': 'Pharmax Research Inc, Orange, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'Janssen Research and Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Universitätsklinik für Innere Medizin III, Vienna, Austria.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California at San Diego, La Jolla, CA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.010']
3237,32949786,Efficacy and Safety of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults with Chronic Hepatitis C Virus Genotypes 1-6 in Brazil.,"INTRODUCTION AND OBJECTIVES


Glecaprevir/pibrentasvir is a highly effective and well tolerated treatment for hepatitis C infection. Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir. This study aimed to assess safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis.
PATIENTS AND METHODS


EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve Brazilian adults with hepatitis C infection genotype 1-6. Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4) received 8 or 12 weeks of glecaprevir/pibrentasvir, respectively. The primary efficacy endpoint was the rate of sustained virologic response at post-treatment Week 12. Secondary endpoints were on-treatment virologic failure and relapse rates. Baseline polymorphisms were assessed in NS3 and NS5A. Adverse events and laboratory abnormalities were monitored.
RESULTS


100 patients were enrolled, 75 received 8 weeks of treatment and 25 received 12 weeks; all patients completed treatment. Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100; 95% confidence interval: 93.0-99.4) and remained high regardless of baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities. 55% of patients reported ≥1 adverse event, the most common being headache (18.0%). Four patients reported serious adverse events; none were considered drug related or led to study drug discontinuation. No hepatic decompensations were observed.
CONCLUSIONS


Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03219216.",2020,Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100;,"['naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis', 'Treatment-Naïve Adults with Chronic Hepatitis C Virus Genotypes 1-6 in Brazil', 'treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis', 'naïve Brazilian adults with hepatitis C infection genotype 1-6', '100 patients', 'Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4', 'Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir']","['glecaprevir/pibrentasvir', 'Glecaprevir/Pibrentasvir', 'Glecaprevir/pibrentasvir']","['effective and well tolerated', 'treatment virologic failure and relapse rates', 'safety and efficacy', 'Efficacy and Safety', 'baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities', 'rate of sustained virologic response', 'hepatic decompensations', 'NS3 and NS5A. Adverse events and laboratory abnormalities', 'Overall sustained virologic response', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}]","[{'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",100.0,0.0808733,Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100;,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Peribañez-Gonzalez', 'Affiliation': 'Hospital Dia, Av Dr Arnaldo, 165, Segundo andar, São Paulo, Brazil. Electronic address: mpgonzalez@terra.com.br.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cheinquer', 'Affiliation': 'Ramiro Barcelos 2350, CPC Sala, 21216, Porto Alegre, Brazil. Electronic address: drhugo@terra.com.br.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Rodrigues', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: lino.rodrigues@abbvie.com.'}, {'ForeName': 'Maria Patelli', 'Initials': 'MP', 'LastName': 'Lima', 'Affiliation': 'Instituto de Infectologia Campinas, Rua Dr. Quirino, 524, Sala 72, Centro, Campinas, Brazil. Electronic address: mariapatelli@uol.com.br.'}, {'ForeName': 'Mário Reis', 'Initials': 'MR', 'LastName': 'Álvares-da-Silva', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, GI/Liver Division, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: marioreis@live.com.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Madruga', 'Affiliation': 'Rua Santa Cruz, 81- Vila Mariana, São Paulo, Brazil. Electronic address: valdezmr@uol.com.br.'}, {'ForeName': 'Edison Roberto', 'Initials': 'ER', 'LastName': 'Parise', 'Affiliation': 'Rua Diogo de Faria 816 Vila Clementino, São Paulo, Brazil. Electronic address: parise@sbhepatologia.org.br.'}, {'ForeName': 'Mário Guimarães', 'Initials': 'MG', 'LastName': 'Pessoa', 'Affiliation': 'Division of Gastroenterology and Hepatology University of São Paulo School of Medicine, Avenida Enéas de Carvalho Aguiar, 255 - Bloco B - 4º andar, São Paulo, Brazil. Electronic address: mgpessoa@uol.com.br.'}, {'ForeName': 'Juvencio', 'Initials': 'J', 'LastName': 'Furtado', 'Affiliation': 'Rua Cônego Xavier, 276 - Amb de Infectologia, São Paulo, Brazil. Electronic address: juvencio.furtado@terra.com.br.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Villanova', 'Affiliation': 'Hospital das ClÍnicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Campus Universitário s/n, Monte Alegre, Bloco G Subsolo 2, Unidade de Pesquisa Clinica, Ribeirão Preto, Brazil. Electronic address: marciagvillanova@gmail.com.'}, {'ForeName': 'Adalgisa', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': 'Centro de Pesquisa Clínica Hospital Universitario da Universidade Federal do Maranhão, Rua Almirante Tamandaré, 01. Centro, São Luís, Brazil. Electronic address: adalgisaf@terra.com.br.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Mazzoleni', 'Affiliation': 'Hospital Ernesto Dornelles, Av. Ipiranga 1801, 7ºAndar, Cpda-Pesquisa, Porto Alegre, Brazil. Electronic address: fimazzoleni@hotmail.com.'}, {'ForeName': 'Ecio', 'Initials': 'E', 'LastName': 'Nascimento', 'Affiliation': 'Av. Mandacaru, 1590, Maringá, Brazil. Electronic address: eanascimento@uem.br.'}, {'ForeName': 'Giovanni Faria', 'Initials': 'GF', 'LastName': 'Silva', 'Affiliation': 'Unesp Campus de Botucatu, Rua Prof Dr Armanda Alves, s/n(0) Bairro: Botucatu, Brazil. Electronic address: Giovanni.f.silva@unesp.br.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Fredrick', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: linda.m.fredrick@abbvie.com.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: Preethi.krishnan@abbvie.com.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Burroughs', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: Margaret.burroughs@abbvie.com.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Reuter', 'Affiliation': 'Marechal Campos Av. 1355, Outclinic number 5, Vitoria, Brazil. Electronic address: tania.reuter@gmail.com.'}]",Annals of hepatology,['10.1016/j.aohep.2020.09.002']
3238,32949787,A clinico-microbiological and biochemical study evaluating the adjunctive use of antimicrobial photodynamic therapy and local drug delivery of 1.2 % simvastatin gel compared to scaling and root planing alone.,"BACKGROUND


To evaluate and compare the efficacy of antimicrobial Photodynamic therapy (aPDT), Local Drug Delivery (LDD) of 1.2 % Simvastatin gel as an adjunct to scaling and root planning (SRP) and SRP alone in the treatment of Periodontitis using clinical, microbiological and biochemical parameters.
MATERIALS AND METHODS


A total of 33 test sites in 11 Grade A Stage II periodontitis patients were randomly divided into three groups: GROUP I: Treated by SRP alone (SRP group); GROUP II: Treated by SRP followed by aPDT (aPDT group); GROUP III: Treated by SRP followed by single subgingival application of 1.2 % simvastatin gel (SMV group). Clinical parameters including API, PBI, PPD and RAL were assessed. Quantification of Porphyromonas gingivalis was evaluated by RT -PCR technique and estimation of RANKL levels was checked by ELISA. All assessments were done at baseline and 3 months RESULTS: All three groups showed significant reduction in the scores of clinical parameters, P. gingivalis DNA copy numbers and GCF RANKL levels at 3 months post therapy compared to baseline (p < 0.05). On comparison between the three groups, the results were non significant for all parameters both at baseline and at 3 months post therapy (p > 0.05). However slightly greater reduction was seen in the mean scores of PPD and RAL in the SMV Group and in P. gingivalis DNA copy numbers and GCF RANKL levels in aPDT group compared to the other groups although statistically non significant. A significant positive correlation(p < 0.05) was observed between P. gingivalis DNA copy numbers and PPD scores in SMV group and a significant negative correlation(p < 0.05) was observed between P. gingivalis DNA copy numbers and API & PBI scores in SRP group at 3 months follow up.
CONCLUSIONS


aPDT, 1.2 % SMV local drug delivery as adjunct to SRP and SRP alone are effective in improving clinical parameters, reducing P. gingivalis DNA copy numbers and GCF RANKL levels. The superiority of one over another modality of treatment could not be established in this short term study.",2020,"All three groups showed significant reduction in the scores of clinical parameters, P. gingivalis DNA copy numbers and GCF RANKL levels at 3 months post therapy compared to baseline (p < 0.05).",['A total of 33 test sites in 11 Grade A Stage II periodontitis patients'],"['antimicrobial Photodynamic therapy (aPDT), Local Drug Delivery (LDD) of 1.2 % Simvastatin gel', 'simvastatin gel', 'SRP alone (SRP group); GROUP II: Treated by SRP followed by aPDT (aPDT group); GROUP III: Treated by SRP followed by single subgingival application of 1.2 % simvastatin gel (SMV group', 'antimicrobial photodynamic therapy']","['API & PBI scores', 'API, PBI, PPD and RAL', 'PPD scores', 'scores of clinical parameters, P. gingivalis DNA copy numbers and GCF RANKL levels', 'mean scores of PPD and RAL']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3693482', 'cui_str': 'Giant cell fibroblastoma'}, {'cui': 'C0666361', 'cui_str': 'TNFSF11 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0207791,"All three groups showed significant reduction in the scores of clinical parameters, P. gingivalis DNA copy numbers and GCF RANKL levels at 3 months post therapy compared to baseline (p < 0.05).","[{'ForeName': 'Sartaz', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India. Electronic address: neena_rahman@yahoo.co.in.'}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Gv', 'Affiliation': 'Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India. Electronic address: gayathri_dental@rediffmail.com.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Mehta', 'Affiliation': 'Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India. Electronic address: dsmehta2010@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102017']
3239,32949918,A high-protein meal does not improve blood pressure or vasoactive biomarker responses to acute exercise in humans.,"Blood pressure (BP) responses to exercise yield prognostic information beyond resting BP. While habitual higher dietary protein intake is associated with reduced resting BP, few studies have assessed the impact of high-protein meals on acute BP and vasoactive biomarker responses to exercise. To test the hypothesis that consuming a higher-protein, lower fat meal (HP; 30 g protein, 17 g fat, 52 g carbohydrate) would attenuate the BP response to exercise and result in a more robust post-exercise hypotensive response compared to a lower-protein, higher-fat meal (LP; 13 g protein, 25 g fat, 54 g carbohydrate), we recruited 31 pre-hypertensive subjects to complete this randomized, double-blind, cross-over acute feeding study. One hundred sixty-five minutes after consuming the test HP or LP meal, subjects exercised on a cycle ergometer at 70% VO 2  max for 30 minutes. Blood pressure was measured prior to the meal and periodically before, during, and after exercise for a 315-minute period. Blood samples were periodically collected to quantify plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites in a subset of subjects (n = 15) as shown in Supplemental Table S1. Consuming the HP meal did not influence the BP responses to exercise, including the post-exercise return to baseline BP or systolic BP area under the curve. While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered. These results suggest that consuming a higher-protein, lower-fat meal does not influence BP or vasoactive biomarker responses to exercise compared to a lower-protein, higher-fat meal.",2020,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","['humans', '31 pre-hypertensive subjects']","['carbohydrate', 'HP meal']","['postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites', 'plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites', 'BP responses', 'post-exercise return to baseline BP or systolic BP area under the curve', 'blood pressure or vasoactive biomarker responses', 'Blood pressure', 'BP response', 'Blood pressure (BP) responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0067305', 'cui_str': ""N,N'-dimethylarginine""}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.037945,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Bergia', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907.'}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Campbell', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907. Electronic address: campbellw@purdue.edu.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Roseguini', 'Affiliation': 'Department of Health & Kinesiology, Purdue University, 800 W Stadium Ave, West Lafayette, IN 47907.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Food Science and Technology Programme, c/o Department of Chemistry, National University of Singapore, 3 Science Drive 3, Singapore 117543. Electronic address: chmkje@nus.edu.sg.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.001']
3240,32949941,Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial.,"PURPOSE


To investigate whether Immersive Virtual Reality (VR) has a greater positive influence on oncology patients' physical and emotional mood states when compared to an iPad attentional control condition. Our secondary objective was to understand what factors influenced VR effectiveness.
METHOD


Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver. Using a randomized controlled study design patients were allocated to VR (three content groups) or an iPad control condition. Pre-post-intervention self-report state measures were collected using visual analogue scales and an objective measure of physiological arousal (pulse rate). Post-intervention, patients reported on level of immersion, enjoyment and simulator sickness.
RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes. However, patients accessing Immersive VR consistently reported greater positive shifts in mood state and reductions in negative symptoms when compared with iPad. No change was observed in physiological arousal levels (pulse rate) in either condition before, during or immediately after intervention. Moderation analysis showed that the degree of child illness (PedsQL), sex, age, and level of immersion were important in influencing the magnitude of differences between the VR and iPad conditions on mood, anxiety and pain.
CONCLUSIONS


These preliminary findings support the use of Immersive VR in clinical oncology settings to improve patient well-being. Further studies examining the application of Immersive VR in supporting children adjusting to hospitalization and cancer treatment are therefore warranted. Factors found to moderate VR effectiveness provide important clinical implications.",2020,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","['Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver', 'Pediatric Oncology']","['Immersive VR', 'Immersive Virtual Reality', 'Immersive Virtual Reality (VR', 'iPad control condition']","['physiological arousal levels (pulse rate', 'physiological arousal (pulse rate', 'mood, anxiety and pain', 'level of immersion, enjoyment and simulator sickness', 'VR effectiveness', 'degree of child illness (PedsQL), sex, age, and level of immersion', 'negative symptoms']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0255989,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tennant', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia. Electronic address: michelle.tennant@mcri.edu.au.""}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Youssef', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Centre for Adolescent Health, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Deakin Child Study Centre, School of Psychology, Deakin University, Burwood, Victoria, 3125, Australia.'}, {'ForeName': 'Tara-Jane', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McMillan', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'McCarthy', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia; Department of Paediatrics, University of Melbourne, Parkville, Victoria, 3052, Australia.""}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101804']
3241,32949942,The effect of individualized education with support on breast cancer patients' anxiety and depression during radiation therapy: A pilot study.,"PURPOSE


This study was undertaken to determine the effects of individualized education with support intervention on breast cancer patients' anxiety and depression while undergoing radiation therapy (RT). Moreover, the intervention was assessed for its feasibility in the context of Pakistan.
METHODS


A quasi-experimental design was used to conduct this study in RT department of a public hospital in Karachi. A total of 61 breast cancer patients receiving radiation as adjuvant therapy participated in the study. The experimental group (n = 31) received individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT. In addition, the nurse remained available for the consultation during the RT sessions and on telephone throughout the RT period. However, the control group received only information booklet. Patients' anxiety and depression were measured in both of the groups before the commencement of RT, and at the completion of RT by using the Aga Khan University Anxiety and Depression Scale (AKUADS).
RESULTS


A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test. The overall mean anxiety and depression scores of the control group showed no significant difference (p = 0.187). The effect size of the intervention was large (Cohen's d = 2.5).
CONCLUSION


The intervention was effective in reducing anxiety and depression among breast cancer patients receiving RT. Replication of the study on a larger scale in multiple settings on other cancer patients is recommended.",2020,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"['61 breast cancer patients receiving radiation as adjuvant therapy participated in the study', ""breast cancer patients' anxiety and depression during radiation therapy"", ""breast cancer patients' anxiety and depression while undergoing radiation therapy (RT"", 'RT department of a public hospital in Karachi', 'breast cancer patients receiving RT']","['individualized education', 'individualized education with support intervention', 'individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT']","['overall mean anxiety and depression scores', 'anxiety and depression']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0131595,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"[{'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Zaheer', 'Affiliation': 'Institute of Nursing, Combined Military Hospital (CMH) Lahore Medical College, Pakistan. Electronic address: shaziazaheer911@gmail.com.'}, {'ForeName': 'Raisa B', 'Initials': 'RB', 'LastName': 'Gul', 'Affiliation': 'Shifa Tameer-e-Millat University, Shifa College of Nursing, Islamabad, Pakistan.'}, {'ForeName': 'Shireen S', 'Initials': 'SS', 'LastName': 'Bhamani', 'Affiliation': 'Aga Khan University School of Nursing and Midwifery, Karachi, Pakistan.'}, {'ForeName': 'Muhammad A', 'Initials': 'MA', 'LastName': 'Memon', 'Affiliation': 'Atomic Energy Medical Center, Jinnah Post Graduate Medical Center, Karachi, Pakistan.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101826']
3242,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND


and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS


A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS


27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION


KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
3243,32949957,The long-term outcomes of tobacco control strategies based on the cognitive intervention for smoking cessation in COPD patients.,"OBJECTIVE


To evaluate the long-term efficacy of tobacco control strategies based on cognitive intervention for smoking cessation in chronic obstructive pulmonary disease (COPD) patients, and to provide basis for clinical practice.
MATERIALS AND METHODS


102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study. These smokers were randomly divided into intervention group and control group. The intervention group received a cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc. The prevalence of quitting smoking, acute exacerbation (AE), lung function and survival were compared in the groups in 10 years.
RESULTS


There were significant differences between the intervention group and the control group in the rate of persistent quitting smoking in half a year (17.6% vs 3.9%) (P < 0.05), the rate of quitting smoking at the 6th month (58.8% vs 33.3%) (P < 0.05). After 3 months (P < 0.01) and 6 months (P < 0.01), the difference in body weight between the intervention group and the control group was statistically significant. Intervention-group patients had fewer AE per year (P < 0.01) and higher FEV1/FVC ratio (P < 0.01) after 5-year and 10-year follow-up. Besides, the FEV1% predicted in the intervention patients was higher than that in control group after 10-year follow-up. The ages of patients in the death group were greater than those in the survival group. Death-group patients had longer smoking times, higher smoking index, and later onset of COPD symptoms. Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P < 0.01). During 10-year follow-up, 30 patient deaths were recorded (the control group: n = 48; 19 deaths, and intervention group: n = 46; 11 deaths), and patients in the control group had lower survival than those in the intervention group. (P < 0.05).
CONCLUSION


The method of quitting smoking based on cognitive intervention is an effective way for COPD patients to quit smoking successfully. Quitting smoking can slower deterioration in lung function and improve the survival of COPD patients.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR2000031239 (Chinese clinical trial registry).",2020,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"['102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study', 'COPD patients', 'chronic obstructive pulmonary disease (COPD) patients']","['tobacco control strategies', 'cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc', 'quitting smoking based on cognitive intervention', 'cognitive intervention']","['prevalence of quitting smoking, acute exacerbation (AE), lung function and survival', 'longer smoking times, higher smoking index, and later onset of COPD symptoms', 'higher FEV1/FVC ratio', 'body weight', 'rate of quitting smoking', 'rate of persistent quitting smoking', 'lower survival', 'FEV1/FVC ratio']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",102.0,0.0291403,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: leisi0831@csu.edu.cn.'}, {'ForeName': 'Meilei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 593194666@qq.com.'}, {'ForeName': 'Wenbing', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 837216794@qq.com.'}, {'ForeName': 'Caiqin', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 1974546139@qq.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: pingchen0731@csu.edu.cn.'}, {'ForeName': 'Shangjie', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: wushangjie@csu.edu.cn.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106155']
3244,32949986,Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib).,"BACKGROUND


Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population.
METHODS


Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017. Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA 2 DS 2 -VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis. The main outcome measures of the current analysis were rates of OAC use in the prior 12 months of cohort identification and factors associated with non-use.
RESULTS


A total of 197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment. Of these, 179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old. Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis. Of these, 32,295 (33%) had no evidence of OAC use in the prior 12 months. Compared with patients with evidence of OAC use in the prior 12 months, patients without OAC use were more likely to be ≥80 years old, women, and have a history of anemia (51% vs 47%) and less likely to have diabetes (41% vs 44%), history of stroke or TIA (15% vs 19%), and history of heart failure (39% vs 48%).
CONCLUSIONS


Despite a high risk of stroke, one-third of privately insured patients with AF and no obvious contraindications to an OAC were not treated with an OAC. There is an unmet need for evidence-based interventions that could lead to greater use of OACs in patients with AF at risk for stroke.",2020,"Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis.","['Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017', 'patients with Atrial Fibrillation (IMPACT-AFib', '197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment', '179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old', 'patients with AF at risk for stroke', 'patients with atrial fibrillation (AF', 'Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA 2 DS 2 -VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis', 'privately insured patients with atrial fibrillation', 'Half of the patients (98,903']","['oral anticoagulants (OACs', 'OACs', 'oral AntiCoagulanTs', 'oral anticoagulants']","['rates of OAC use', 'history of anemia', 'history of heart failure', 'history of stroke or TIA']","[{'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0559154', 'cui_str': 'H/O: anemia'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]",197806.0,0.0480647,"Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis.","[{'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: alkha001@mc.duke.edu.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore, Inc., Wilmington, DE.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Goldsack', 'Affiliation': 'The Clinical Trials Transformation Initiative, Durham, NC.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harkins', 'Affiliation': 'Humana Healthcare Research, Louisville, KY.'}, {'ForeName': 'Noelle M', 'Initials': 'NM', 'LastName': 'Cocoros', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Lin', 'Affiliation': 'OptumInsight Life Sciences, Boston, MA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Lipowicz', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'McCall', 'Affiliation': 'Rowan Tree Perspectives Consulting, Murrieta, CA.'}, {'ForeName': 'Vinit', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Humana Healthcare Research, Louisville, KY.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Parlett', 'Affiliation': 'HealthCore, Inc., Wilmington, DE.'}, {'ForeName': 'Cheryl N', 'Initials': 'CN', 'LastName': 'McMahill-Walraven', 'Affiliation': 'Aetna, Inc., Blue Bell, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Platt', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2020.07.012']
3245,32500344,Is Postoperative Adjuvant Transcatheter Arterial Infusion Therapy Effective for Patients with Hepatocellular Carcinoma who Underwent Hepatectomy? A Prospective Randomized Controlled Trial.,"BACKGROUND


The effectiveness of adjuvant transcatheter arterial chemo- or/and chemoembolization therapy after curative hepatectomy of initial hepatocellular carcinoma (HCC) is controversial. This study aimed to evaluate whether hepatectomy combined with adjuvant transcatheter arterial infusion therapy (TAI) for initial HCC has better long-term survival outcomes than hepatectomy alone.
METHODS


From January 2012 to December 2014, a prospective randomized controlled trial of patients with initial HCC was conducted. Then, 114 initial HCC patients were recruited to undergo hepatectomy with adjuvant TAI (TAI group, n = 55) or hepatectomy alone (control group, n = 59) at our institution. The TAI therapy was performed twice, at 3 and 6 months after curative hepatectomy (UMIN 000011900).
RESULTS


The patients treated with TAI had no serious side effects, and operative outcomes did not differ between the two groups. No significant differences were found in the pattern of intrahepatic recurrence or time until recurrence between the two groups. Moreover, no significant differences were found in the relapse-free survival or overall survival. Low cholinesterase level (< 200) had been identified as a risk factor affecting relapse-free survival. Furthermore, compared with surgery alone, adjuvant TAI with hepatectomy improved the overall survival for lower-cholinesterase patients.
CONCLUSIONS


Adjuvant TAI is safe and feasible, but it cannot reduce the incidence of postoperative recurrence or prolong survival for patients who underwent curative hepatectomy for initial HCC.",2020,"Furthermore, compared with surgery alone, adjuvant TAI with hepatectomy improved the overall survival for lower-cholinesterase patients.
","['Patients with Hepatocellular Carcinoma who Underwent Hepatectomy', 'curative hepatectomy of initial hepatocellular carcinoma (HCC', '114 initial HCC patients were recruited to undergo', 'patients with initial HCC', 'From January 2012 to December 2014', 'patients who underwent curative hepatectomy for initial HCC']","['hepatectomy combined with adjuvant transcatheter arterial infusion therapy (TAI', 'TAI', 'hepatectomy with adjuvant TAI (TAI group, n\u2009=\u200955) or hepatectomy alone (control group, n\u2009=\u200959) at our institution', 'adjuvant transcatheter arterial chemo- or/and chemoembolization therapy']","['pattern of intrahepatic recurrence or time until recurrence', 'overall survival', 'serious side effects, and operative outcomes', 'relapse-free survival or overall survival', 'Low cholinesterase level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0202207', 'cui_str': 'Cholinesterase measurement'}]",,0.0610251,"Furthermore, compared with surgery alone, adjuvant TAI with hepatectomy improved the overall survival for lower-cholinesterase patients.
","[{'ForeName': 'Fumitoshi', 'Initials': 'F', 'LastName': 'Hirokawa', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan. sur122@osaka-med.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Komeda', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Taniguchi', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Asakuma', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Tetsunosuke', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kagota', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tomioka', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Radiology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Osaka, Japan.'}]",Annals of surgical oncology,['10.1245/s10434-020-08699-w']
3246,30887823,"Editorial Comment on:  ""Ureteral Wall Injury with Ureteral Access Sheaths: A Randomized Prospective Trial"" by Loftus et al.",,2020,,"['on:  Ureteral Wall Injury with Ureteral Access Sheaths', 'J Endourol 2019']",['Editorial Comment'],[],"[{'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}]","[{'cui': 'C0282411', 'cui_str': 'Commentary'}]",[],,0.020139,,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sofer', 'Affiliation': 'Department of Urology, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Giusti', 'Affiliation': 'Ville Turro Division, Department of Urology, IRCCS San Raffaele Hospital, Milan, Italy.'}]",Journal of endourology,['10.1089/end.2019.0184']
3247,31375613,Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity.,"INTRODUCTION


Technological and medical advances have led to a growing population of children with medical complexity (CMC) defined by substantial medical needs, healthcare utilisation and morbidity. These children are at a high risk of missed, fragmented and/or inappropriate care, and families bear extraordinary financial burden and stress. While small in number (<1% of children), this group uses ~1/3 of all child healthcare resources, and need coordinated care to optimise their health. Complex care for kids Ontario (CCKO) brings researchers, families and healthcare providers together to develop, implement and evaluate a population-level roll-out of care for CMC in Ontario, Canada through a randomised controlled trial (RCT) design. The intervention includes dedicated key workers and the utilisation of coordinated shared care plans.
METHODS AND ANALYSIS


Our primary objective is to evaluate the CCKO intervention using a randomised waitlist control design. The waitlist approach involves rolling out an intervention over time, whereby all participants are randomised into two groups (A and B) to receive the intervention at different time points determined at random. Baseline measurements are collected at month 0, and groups A and B are compared at months 6 and 12. The primary outcome is the family-prioritized Family Experiences with Coordination of Care (FECC) survey at 12 months. The FECC will be compared between groups using an analysis of covariance with the corresponding baseline score as the covariate. Secondary outcomes include reports of child and parent health outcomes, health system utilisation and process outcomes.
ETHICS AND DISSEMINATION


Research ethics approval has been obtained for this multicentre RCT. This trial will assess the effect of a large population-level complex care intervention to determine whether dedicated key workers and coordinated care plans have an impact on improving service delivery and quality of life for CMC and their families.
TRIAL REGISTRATION NUMBER


NCT02928757.",2019,The primary outcome is the family-prioritized Family Experiences with Coordination of Care (FECC) survey at 12 months.,"['children with medical complexity', 'kids Ontario (CCKO', 'kids Ontario']",['CCKO intervention'],"['family-prioritized Family Experiences with Coordination of Care (FECC) survey', 'reports of child and parent health outcomes, health system utilisation and process outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",,0.13211,The primary outcome is the family-prioritized Family Experiences with Coordination of Care (FECC) survey at 12 months.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Orkin', 'Affiliation': 'Division of Pediatric Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Carol Y', 'Initials': 'CY', 'LastName': 'Chan', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Fayed', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Jia Lu Lilian', 'Initials': 'JLL', 'LastName': 'Lin', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Major', 'Affiliation': ""Department of Paediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lim', 'Affiliation': 'Department of Pediatrics, Hamilton Health Sciences Center, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Peebles', 'Affiliation': 'Department of Pediatrics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Clinical Trials Unit, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Soscia', 'Affiliation': 'Division of Pediatric Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Sultan', 'Affiliation': 'The Provincial Council for Maternal and Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'Clinical Trials Unit, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Guttmann', 'Affiliation': 'Division of Pediatric Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Bartlett', 'Affiliation': 'Department of Pediatrics, Royal Victoria Regional Health Centre, Barrie, Ontario, Canada.'}, {'ForeName': 'Ronik', 'Initials': 'R', 'LastName': 'Kanani', 'Affiliation': 'Department of Pediatrics, North York General Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Culbert', 'Affiliation': 'The Credit Valley Hospital, Trillium Health Partners, Mississauga, Ontario, Canada.'}, {'ForeName': 'Karolyn', 'Initials': 'K', 'LastName': 'Hardy-Brown', 'Affiliation': 'Peterborough Regional Health Centre, Peterborough, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Gordon', 'Affiliation': ""Department of Pediatrics, Orillia Soldier's Memorial Hospital, Orillia, Ontario, Canada.""}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Perlmutar', 'Affiliation': 'Department of Pediatrics, Michael Garron Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Cohen', 'Affiliation': 'Division of Pediatric Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-028121']
3248,31389723,A win ratio approach to the re-analysis of Multiple Risk Factor Intervention Trial.,"BACKGROUND


Composite outcomes, which combine multiple types of clinical events into a single outcome, are common in clinical trials. The usual analysis considers the time to first occurrence of any event in the composite. The major criticisms of such an approach are (1) this implicitly treats the outcomes as if they were of equal importance, but they often vary in terms of clinical relevance and severity, (2) study participants often experience more than one type of event, and (3) often less severe events occur before more severe ones, but the usual analysis disregards any information beyond that first event.
METHODS


A novel approach, referred to as the win ratio, which addresses the aforementioned criticisms of composite outcomes, is illustrated with a re-analysis of data on fatal and non-fatal cardiovascular disease time-to-event outcomes reported for the Multiple Risk Factor Intervention Trial. In this trial, 12,866 participants were randomized to a special intervention group ( n  = 6428) or a usual care ( n  = 6438) group. Non-fatal outcomes were ranked by risk of cardiovascular disease death up to 20 years after trial. In one approach, participants in the special intervention and usual care groups were first matched on coronary heart disease risk at baseline and time of enrollment. Each matched pair was categorized as a winner or loser depending on which one experienced a cardiovascular disease death first. If neither died of cardiovascular disease causes, they were evaluated on the most severe non-fatal outcome. This process continued for all the non-fatal outcomes. A second win ratio statistic, obtained from Cox partial likelihood, was also estimated. This statistic provides a valid estimate of the win ratio using multiple events if the marginal and conditional survivor functions of each outcome satisfy proportional hazards. Loss ratio statistics (inverse of win ratios) are compared to hazard ratios from the usual first event analysis. A larger 11-event composite was also considered.
RESULTS


For the 7-event cardiovascular disease composite, the previously reported first event analysis based on 581 events in the special intervention group and 652 events in the usual care group yielded a hazard ratio (95% confidence interval) of 0.89 (0.79-0.99), compared to 0.86 (0.77-0.97) and 0.91 (0.81-1.02) for the severity ranked estimates. Results for the 11-event composite also confirmed the findings of the first event analysis.
CONCLUSION


The win ratio analysis was able to leverage information collected past the first experienced event and rank events by severity. The results were similar to and confirmed previously reported traditional first event analysis. The win ratio statistic is a useful adjunct to the traditional first event analysis for trials with composite outcomes.",2019,"RESULTS


For the 7-event cardiovascular disease composite","['12,866 participants']",['special intervention group ( n \u2009=\u20096428) or a usual care ( n \u2009=\u20096438) group'],"['hazard ratio', 'cardiovascular disease death', 'Loss ratio statistics']",[],"[{'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",,0.0615533,"RESULTS


For the 7-event cardiovascular disease composite","[{'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Kotalik', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Qinshu', 'Initials': 'Q', 'LastName': 'Lian', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Serrano', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Connett', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519868233']
3249,32195655,A Qualitative Study of Increased Pediatric Reutilization After a Postdischarge Home Nurse Visit.,"BACKGROUND


The Hospital to Home Outcomes (H2O) trial was a 2-arm, randomized controlled trial that assessed the effects of a nurse home visit after a pediatric hospital discharge. Children randomized to the intervention had higher 30-day postdischarge reutilization rates compared with those with standard discharge. We sought to understand perspectives on why postdischarge home nurse visits resulted in higher reutilization rates and to elicit suggestions on how to improve future interventions.
METHODS


We sought qualitative input using focus groups and interviews from stakeholder groups: parents, primary care physicians (PCP), hospital medicine physicians, and home care registered nurses (RNs). A multidisciplinary team coded and analyzed transcripts using an inductive, iterative approach.
RESULTS


Thirty-three parents participated in interviews. Three focus groups were completed with PCPs (n = 7), 2 with hospital medicine physicians (n = 12), and 2 with RNs (n = 10). Major themes in the explanation of increased reutilization included: appropriateness of patient reutilization; impact of red flags/warning sign instructions on family's reutilization decisions; hospital-affiliated RNs ""directing traffic"" back to hospital; and home visit RNs had a low threshold for escalating care. Major themes for improving design of the intervention included: need for improved postdischarge communication; individualizing home visits-one size does not fit all; and providing context and framing of red flags.
CONCLUSION


Stakeholders questioned whether hospital reutilization was appropriate and whether the intervention unintentionally directed patients back to the hospital. Future interventions could individualize the visit to specific needs or diagnoses, enhance postdischarge communication, and better connect patients and home nurses to primary care.",2020,Children randomized to the intervention had higher 30-day postdischarge reutilization rates compared with those with standard discharge.,"['Thirty-three parents participated in interviews', 'n = 7), 2 with hospital medicine physicians (n = 12), and 2 with RNs (n = 10', 'stakeholder groups: parents, primary care physicians (PCP), hospital medicine physicians, and home care registered nurses (RNs']",['PCPs'],['30-day postdischarge reutilization rates'],"[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C3658340', 'cui_str': 'Hospital Medicine'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",33.0,0.0821655,Children randomized to the intervention had higher 30-day postdischarge reutilization rates compared with those with standard discharge.,"[{'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Riddle', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Sherman', 'Affiliation': 'SNS Research, Cincinnati, Ohio.'}, {'ForeName': 'Margo J', 'Initials': 'MJ', 'LastName': 'Moore', 'Affiliation': ""Division of Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Loechtenfeldt', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Tubbs-Cooley', 'Affiliation': 'College of Nursing, Martha S. Pitzer Center for Women, Children and Youth, Columbus, Ohio.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': ""Division of Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wade-Murphy', 'Affiliation': ""Division of Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Beck', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Statile', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Shah', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Auger', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hospital medicine,['10.12788/jhm.3370']
3250,31779535,The Green Light for Green Dot: A Qualitative Study of Factors Influencing Adoption of an Efficacious Violence Prevention Program in High School Settings.,"The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention. High schools participating in a cluster-randomized controlled trial that found significant declines in sexual violence over time and with full implementation were invited to adopt this program (Green Dot) at no cost. Three emergent themes arose from interviews with 10 intervention implementers. These findings have implications for researchers, practitioners, and high school administrators and may facilitate future program marketing efforts and the development and testing of strategies for targeted dissemination of this and other bystander programs for violence.",2020,The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention.,['High School Settings'],"['Green Light for Green Dot', 'bystander-based sexual violence prevention intervention']",['sexual violence'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1306567', 'cui_str': 'Green light (physical force)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]",,0.0177074,The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention.,"[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Davidov', 'Affiliation': 'West Virginia University, Morgantown, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'NYU Winthrop Hospital, Mineola, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Coker', 'Affiliation': 'University of Kentucky, Lexington, USA.'}]",Violence against women,['10.1177/1077801219886377']
3251,31533069,Alirocumab efficacy and safety by body mass index: A pooled analysis from 10 Phase 3 ODYSSEY trials.,"AIMS


Increased body mass index (BMI) contributes to cardiovascular risk and may influence efficacy of therapeutic antibodies. We investigated the effect of baseline BMI on efficacy and safety of alirocumab, a PCSK9 monoclonal antibody.
METHODS


In a post-hoc analysis, data were pooled from 10 Phase 3 trials (n=4975) of alirocumab vs. placebo/ezetimibe controls. Alirocumab dose was 150mg every 2 weeks in two trials, and 75mg every 2 weeks with possible increase to 150mg at 12 weeks (based on Week 8 low-density lipoprotein cholesterol [LDL-C]) in eight trials. Efficacy/safety data were assessed in baseline BMI subgroups of≤25,>25 to 30,>30 to 35, and>35kg/m 2 .
RESULTS


Baseline LDL-C levels were lower among patients in the higher BMI subgroups. Significant LDL-C reductions from baseline were observed at Weeks 12 and 24 for alirocumab vs. controls, of similar magnitude regardless of baseline BMI (interaction P-value=0.7119). LDL-C<1.81mmol/L (<70mg/dL) was achieved at Week 24 by 69.8-76.4% of alirocumab-treated patients and 9.7-18.4% of control-treated patients, with no pattern by BMI. A greater proportion of patients in higher vs. lower BMI subgroups required alirocumab dose increase (P=0.0343); proportions were 22.5%, 24.9%, 31.7%, and 27.2% of patients across BMI subgroups of≤25,>25 to 30,>30 to 35, and>35kg/m 2 , respectively. Adverse event frequencies were similar regardless of BMI; injection-site reaction frequency was higher with alirocumab (5.1-8.2% across BMI categories) vs. controls (3.6-4.8%).
CONCLUSIONS


Alirocumab provided consistent LDL-C reductions, with similar safety findings across BMI subgroups.",2020,"Significant LDL-C reductions from baseline were observed at Weeks 12 and 24 for alirocumab vs. controls, of similar magnitude regardless of baseline BMI (interaction P-value=0.7119).",[],"['alirocumab vs. placebo/ezetimibe', 'alirocumab', 'Alirocumab']","['Baseline LDL-C levels', 'LDL-C<1.81mmol/L', 'Efficacy/safety data', 'BMI; injection-site reaction frequency', 'Significant LDL-C reductions', 'Alirocumab efficacy and safety by body mass index']",[],"[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",8.0,0.181748,"Significant LDL-C reductions from baseline were observed at Weeks 12 and 24 for alirocumab vs. controls, of similar magnitude regardless of baseline BMI (interaction P-value=0.7119).","[{'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Tinahones', 'Affiliation': 'Hospital Universitario Virgen de la Victoria (IBIMA), Málaga University and CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Malaga, Spain. Electronic address: fjtinahones@uma.es.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Department of Cardiology, Leipzig University Hospital, Leipzig, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""L'institut du Thorax, Department of Endocrinology, CIC INSERM 1413, CHU Nantes, Nantes, France.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}]",Diabetes & metabolism,['10.1016/j.diabet.2019.101120']
3252,31632735,Treatment of at-level spinal cord injury pain with botulinum toxin A.,"Study design


Randomized, double-blinded, placebo-controlled, cross-over study.
Objective


To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
Setting


Outpatient SCI clinic, New York, USA.
Methods


Participants were randomized to receive subcutaneous injections of either placebo or BoNTA with follow-up (office visit, telephone, or e-mail) at 2, 4, 8, and 12 weeks to assess the magnitude of pain relief post injection. Crossover of participants was then performed. Those who received placebo received BoNTA, and vice versa, with follow-up at 2, 4, 8, and 12 weeks.
Results


Eight participants completed at least one of the two crossover study arms. Four completed both arms. The median age of the eight participants was 45 years (range 32-61 years) and 75% were male. All had traumatic, T1-L3 level, complete SCI. Although our data did not meet statistical significance, we noted a higher proportion of participants reporting a marked change in average pain intensity from baseline to 8 and 12 weeks post-BoNTA vs. post-placebo (33% vs. 0%). At 2 and 4 weeks post-BoNTA, almost all participants reported some degree of reduced pain, while the same was not seen post-placebo (83% vs. 0%).
Conclusion


The subcutaneous injection of BoNTA may be a feasible approach for the control of at-level SCI pain and is worthy of further study.
Sponsorship


The onabotulinumtoxinA (BOTOX) used in this study was provided by Allergan (Irvine, CA).",2019,"To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
",['The median age of the eight participants was 45 years (range 32-61 years) and 75% were male'],"['placebo', 'botulinum toxin A (BoNTA', 'botulinum toxin A']","['degree of reduced pain', 'average pain intensity', 'traumatic, T1-L3 level, complete SCI']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",8.0,0.484571,"To explore whether botulinum toxin A (BoNTA) could be effective for treating at-level spinal cord injury (SCI) pain.
","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Chun', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Isaiah', 'Initials': 'I', 'LastName': 'Levy', 'Affiliation': '2Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Ajax', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'The Spine and Pain Institute of New York, New York, NY USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Tsai', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Leung', 'Affiliation': '5Department of Physical Medicine and Rehabilitation, Department of Pain Medicine, Northwell Health Physician Partners, Bay Shore, NY USA.'}, {'ForeName': 'Kristell', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kolakowsky-Hayner', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Huang', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Escalon', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Bryce', 'Affiliation': '1Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0221-9']
3253,32205478,Keeping pace with the competition: His bundle versus biventricular pacing in heart failure.,"PURPOSE OF REVIEW


His bundle pacing (HBP) has emerged as a novel method to achieve electrical resynchronization in bundle branch block and as an alternative means to deliver cardiac resynchronization therapy (CRT). There are now data on HBP in CRT-eligible patients from cohort studies and a single pilot randomized controlled trial (RCT).
RECENT FINDINGS


Early clinical data regarding HBP in heart failure have demonstrated echocardiographic and functional improvement similar to traditional biventricular pacing (BiV), mostly when utilized as a bailout to traditional BiV-CRT. A single pilot RCT, His-SYNC, showed a trend toward greater echocardiographic response in an on-treatment analysis, but was underpowered. No large RCTs have reported long-term clinical outcomes. In order to realize any benefit from HBP, output-dependent morphology changes must be demonstrated to ensure the conduction system capture is present. There may be a role for corrective HBP in patients with right bundle branch block and after atrioventricular node ablation, which is theoretically more desirable than traditional BiV. Importantly, however, HBP is likely not to benefit patients with nonspecific intraventricular conduction delay.
SUMMARY


HBP is emerging as an alternative strategy for CRT and may have a role in patients in whom traditional BiV is not achievable or ineffective.",2020,"There may be a role for corrective HBP in patients with right bundle branch block and after atrioventricular node ablation, which is theoretically more desirable than traditional BiV.",['heart failure'],[],['echocardiographic response'],"[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",[],[],,0.0503162,"There may be a role for corrective HBP in patients with right bundle branch block and after atrioventricular node ablation, which is theoretically more desirable than traditional BiV.","[{'ForeName': 'Gaurav A', 'Initials': 'GA', 'LastName': 'Upadhyay', 'Affiliation': 'University of Chicago Medicine, Center for Arrhythmia Care | Heart and Vascular Center, Chicago, Illinois, USA.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Tung', 'Affiliation': ''}]",Current opinion in cardiology,['10.1097/HCO.0000000000000735']
3254,26450585,Psychometric evaluation of the Questionnaire about the Process of Recovery (QPR).,"BACKGROUND


Supporting recovery is the aim of national mental health policy in many countries. However, only one measure of recovery has been developed in England: the Questionnaire about the Process of Recovery (QPR), which measures recovery from the perspective of adult mental health service users with a psychosis diagnosis.
AIMS


To independently evaluate the psychometric properties of the 15- and 22-item versions of the QPR.
METHOD


Two samples were used: data-set 1 (n = 88) involved assessment of the QPR at baseline, 2 weeks and 3 months. Data-set 2 (n = 399; trial registration: ISRCTN02507940) involved assessment of the QPR at baseline and 1 year.
RESULTS


For the 15-item version, internal consistency was 0.89, convergent validity was 0.73, test-retest reliability was 0.74 and sensitivity to change was 0.40. Confirmatory factor analysis showed the 15-item version offered a good fit. For the 22-item version, the interpersonal subscale was found to underperform and the intrapersonal subscale overlaps substantially with the 15-item version.
CONCLUSIONS


Both the 15-item and the intrapersonal subscale of the 22-item versions of the QPR demonstrated satisfactory psychometric properties. The 15-item version is slightly more robust and also less burdensome, so it can be recommended for use in research and clinical practice.",2015,"For the 22-item version, the interpersonal subscale was found to underperform and the intrapersonal subscale overlaps substantially with the 15-item version.
",['adult mental health service users with a psychosis diagnosis'],[],['interpersonal subscale'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],[],2.0,0.0257888,"For the 22-item version, the interpersonal subscale was found to underperform and the intrapersonal subscale overlaps substantially with the 15-item version.
","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""Julie Williams, MSc, Mary Leamy, PhD, Francesca Pesola, PhD, Victoria Bird, PhD, Clair Le Boutillier, MSc, Mike Slade, PhD, King's College London, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, London, UK julie.williams@kcl.ac.uk.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Leamy', 'Affiliation': ""Julie Williams, MSc, Mary Leamy, PhD, Francesca Pesola, PhD, Victoria Bird, PhD, Clair Le Boutillier, MSc, Mike Slade, PhD, King's College London, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""Julie Williams, MSc, Mary Leamy, PhD, Francesca Pesola, PhD, Victoria Bird, PhD, Clair Le Boutillier, MSc, Mike Slade, PhD, King's College London, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Bird', 'Affiliation': ""Julie Williams, MSc, Mary Leamy, PhD, Francesca Pesola, PhD, Victoria Bird, PhD, Clair Le Boutillier, MSc, Mike Slade, PhD, King's College London, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Le Boutillier', 'Affiliation': ""Julie Williams, MSc, Mary Leamy, PhD, Francesca Pesola, PhD, Victoria Bird, PhD, Clair Le Boutillier, MSc, Mike Slade, PhD, King's College London, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Slade', 'Affiliation': ""Julie Williams, MSc, Mary Leamy, PhD, Francesca Pesola, PhD, Victoria Bird, PhD, Clair Le Boutillier, MSc, Mike Slade, PhD, King's College London, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, London, UK.""}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.bp.114.161695']
3255,31608833,Exploring Parents' Message Receipt and Message Enactment of the World's First Integrated Movement Behaviour Guidelines for Children and Youth.,"The Canadian 24-Hour Movement Guidelines for Children and Youth are novel in how they integrate the guideline recommendations for the full continuum of movement behaviours, from sleep to vigorous physical activity. Research suggests that the integrated guidelines strategy is perceived favourably, and this study is the first to compare this strategy to traditional segregated guidelines on its effectiveness to disseminate health information. Specifically, this study explored (1) the influence of the integrated guidelines strategy on parents' message receipt and message enactment to support their child meet the guidelines, and (2) the relationship between message receipt and message enactment in a youth movement behaviour context. In this prospective randomized experiment, parents ( n = 162) were randomized to read integrated, segregated, or control guidelines and complete pre, post, and 2-week follow-up surveys. Repeated-measures ANOVAs revealed significantly higher message enactment outcomes among participants in the integrated guidelines group ( p < .05). Message receipt and enactment outcomes were significantly correlated ( r > .171,  p < .05). These findings highlight that parents' initial receipt of a message is important for subsequent behaviour change in a youth movement behaviour context. Furthermore, the integrated guidelines strategy may have an advantage in promoting guideline update and should continue to be explored.",2019,These findings highlight that parents' initial receipt of a message is important for subsequent behaviour change in a youth movement behaviour context.,"['Children and Youth', 'parents ( n =\xa0162']",[],['Message receipt and enactment outcomes'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],[],,0.028936,These findings highlight that parents' initial receipt of a message is important for subsequent behaviour change in a youth movement behaviour context.,"[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Tennant', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Tremblay', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Faulkner', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Gainforth', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Latimer-Cheung', 'Affiliation': ""School of Kinesiology and Health Studies, Queen's University, Kingston, Ontario, Canada.""}]",Journal of health communication,['10.1080/10810730.2019.1651429']
3256,32084251,Racial/ethnic differences in circulating natriuretic peptide levels: The Diabetes Prevention Program.,"Natriuretic peptides are cardiac-derived hormones that enhance insulin sensitivity and reduce fat accumulation. Low natriuretic peptide levels are associated with increased risk of type 2 diabetes mellitus (DM2); a condition with variable prevalence across racial/ethnic groups. Few studies have examined whether circulating natriuretic peptide levels and their response to preventive interventions for DM2 differ by race/ethnicity. The Diabetes Prevention Program (DPP) is a clinical trial (July 31, 1996- July 31, 2001) that randomized participants to preventive interventions for DM2. Using stored serum samples, we examined N-terminus pro-B-type natriuretic peptide (NT-proBNP) levels in 3,220 individuals (56% white; 19% African-American; 15% Hispanic; 5% American-Indian; 5% Asian). The influence of race/ethnicity on NT-proBNP concentrations at baseline and after two years of treatment with placebo, lifestyle, or metformin was examined with multivariable-adjusted regression. At baseline, NT-proBNP differed significantly by race (P < .001), with the lowest values in African-American individuals. Hispanic individuals also had lower baseline NT-proBNP levels compared with whites (P< .001), while NT-proBNP levels were similar between white, American-Indian, and Asian individuals. At two years of follow-up, NT-proBNP levels decreased in African-Americans in each of the DPP study arms, whereas they were stable or increased in the other racial/ethnic groups. In the DPP, African-American individuals had lower circulating NT-proBNP levels compared with individuals in other racial/ethnic groups at baseline and after two years of preventive interventions. Further studies should examine the cardio-metabolic implications of lower natriuretic peptide levels in African-Americans. Trial Registration: ClinicalTrials.gov NCT00004992.",2020,"At two years of follow-up, NT-proBNP levels decreased in African-Americans in each of the DPP study arms, whereas they were stable or increased in the other racial/ethnic groups.","['African-Americans', '3,220 individuals (56% white; 19% African-American; 15% Hispanic; 5% American-Indian; 5% Asian']","['placebo, lifestyle, or metformin']","['baseline NT-proBNP levels', 'NT-proBNP concentrations', 'circulating NT-proBNP levels', 'NT-proBNP levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",,0.0351531,"At two years of follow-up, NT-proBNP levels decreased in African-Americans in each of the DPP study arms, whereas they were stable or increased in the other racial/ethnic groups.","[{'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Gupta', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Vanderbilt University School of Medicine, Nashville, TN, United States of America.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Walford', 'Affiliation': 'Diabetes Research Center (Diabetes Unit), Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Diabetes Prevention Program Data Coordinating Center, The Biostatistics Center, George Washington University, Rockville, MD, United States of America.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Biomarker Research Laboratory/TIMI Clinical Trial Laboratory, Department of Pathology, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Vanderbilt University School of Medicine, Nashville, TN, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0229280']
3257,31743424,Estimating individualized treatment regimes from crossover designs.,"The field of precision medicine aims to tailor treatment based on patient-specific factors in a reproducible way. To this end, estimating an optimal individualized treatment regime (ITR) that recommends treatment decisions based on patient characteristics to maximize the mean of a prespecified outcome is of particular interest. Several methods have been proposed for estimating an optimal ITR from clinical trial data in the parallel group setting where each subject is randomized to a single intervention. However, little work has been done in the area of estimating the optimal ITR from crossover study designs. Such designs naturally lend themselves to precision medicine since they allow for observing the response to multiple treatments for each patient. In this paper, we introduce a method for estimating the optimal ITR using data from a 2 × 2 crossover study with or without carryover effects. The proposed method is similar to policy search methods such as outcome weighted learning; however, we take advantage of the crossover design by using the difference in responses under each treatment as the observed reward. We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.",2020,"We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.",[],[],[],[],[],[],,0.0469592,"We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.","[{'ForeName': 'Crystal T', 'Initials': 'CT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Luckett', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Kahkoska', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Shearrer', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': 'Center of Economic and Social Research, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutrition, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}]",Biometrics,['10.1111/biom.13186']
3258,31724959,His bundle pacing: conduction system capture and clinical impact.,"PURPOSE OF REVIEW


It has been nearly 2 decades since His bundle pacing (HBP) was described and with very first randomized pilot study published, reviewing its impact on clinical practice is inevitable.
RECENT FINDINGS


Inclusion of HBP in the guidelines, along with long-term outcomes, outcomes comparing selective and non selective HBP and investigator initiated randomized pilot comparing with cardiac resynchronization therapy, HBP has established itself as a feasible pacing alternative.
SUMMARY


HBP is an addition to the current armada of resynchronization techniques. HBP is an emerging area of interest, and is particularly relevant in patients, who require chronic ventricular pacing, but the long-term outcomes of this approach in large patient populations with low ejection fraction are still lacking. With several ongoing studies, in the near future we will have good-quality evidence to support native conduction system pacing as a viable alternative to improve meaningful outcomes.",2020,"RECENT FINDINGS


Inclusion of HBP in the guidelines, along with long-term outcomes, outcomes comparing selective and non selective HBP and investigator initiated randomized pilot comparing with cardiac resynchronization therapy, HBP has established itself as a feasible pacing alternative.
",[],[],[],[],[],[],,0.0308583,"RECENT FINDINGS


Inclusion of HBP in the guidelines, along with long-term outcomes, outcomes comparing selective and non selective HBP and investigator initiated randomized pilot comparing with cardiac resynchronization therapy, HBP has established itself as a feasible pacing alternative.
","[{'ForeName': 'Vatsal', 'Initials': 'V', 'LastName': 'Ladia', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Komandoor', 'Initials': 'K', 'LastName': 'Srivathsan', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Mulpuru', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Win-Kuang', 'Initials': 'WK', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Phoenix, Arizona.'}]",Current opinion in cardiology,['10.1097/HCO.0000000000000701']
3259,32191129,The cluster randomized crossover trial: The effects of attrition in the AB/BA design and how to account for it in sample size calculations.,"BACKGROUND/AIMS


This article studies the effect of attrition in the cluster randomized crossover trial. The focus is on the two-treatment two-period AB/BA design where attrition occurs during the washout period. Attrition may occur at either the subject level or the cluster level. In the latter case, clusters drop out entirely and provide no measurements in the second period. Subject attrition can only occur in the cohort design, where each subject receives both treatments. Cluster attrition can also occur in the cross-sectional design, where different subjects are measured in the two time periods. Furthermore, this article explores two different strategies to account for potential levels of attrition: increasing sample size and replacing those subjects who drop out by others.
METHODS


The statistical model that takes into account the nesting of subjects within clusters, and the nesting of repeated measurements within subjects is presented. The effect of attrition is evaluated on the basis of the efficiency of the treatment effect estimator. Matrix algebra is used to derive the relation between efficiency, the degree of attrition, cluster size and the intraclass correlations: the within-cluster within-period correlation, the within-cluster between-period correlation and (in the case of a cohort design) the within-subject correlation. The methodology is implemented in two Shiny Apps.
RESULTS


Attrition in a cluster randomized crossover trial implies a loss of efficiency. Efficiency decreases with an increase of the attrition rate. The loss of efficiency due to attrition of subjects in a cohort design is largest for small number of subjects per cluster-period, but it may be repaired to a large degree by increasing the number of subjects per cluster-period or by replacing those subjects who drop out by others. Attrition of clusters results in a larger loss of efficiency, but this loss does not depend on the number of subjects per cluster-period. Repairing for this loss requires a large increase in the number of subjects per cluster-period. The methodology of this article is illustrated by an example on the effect of lavender scent on dental patients' anxiety.
CONCLUSION


This article provides the methodology of exploring the effect of attrition in cluster randomized crossover trials, and to repair for attrition. As such, it helps researchers plan their trial in an appropriate way and avoid underpowered trials. To use the methodology, prior estimates of the degree of attrition and intraclass correlation coefficients are needed. It is advocated that researchers clearly report the estimates of these quantities to help facilitate planning future trials.",2020,"Matrix algebra is used to derive the relation between efficiency, the degree of attrition, cluster size and the intraclass correlations: the within-cluster within-period correlation, the within-cluster between-period correlation and (in the case of a cohort design) the within-subject correlation.","[""dental patients' anxiety""]",['lavender scent'],['attrition rate'],"[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C2987717', 'cui_str': 'Aroma'}]",[],,0.028077,"Matrix algebra is used to derive the relation between efficiency, the degree of attrition, cluster size and the intraclass correlations: the within-cluster within-period correlation, the within-cluster between-period correlation and (in the case of a cohort design) the within-subject correlation.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Moerbeek', 'Affiliation': 'Department of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.'}]","Clinical trials (London, England)",['10.1177/1740774520913042']
3260,32077519,Three-month efficacy of three knee braces in the treatment of medial knee osteoarthritis in a randomized crossover trial.,"Immediate biomechanical and functional effects of knee braces are often reported, however, the duration and type of knee brace treatment for knee osteoarthritis (KOA) remain unclear. The objective was to evaluate usage, comfort, pain, and knee adduction moment (KAM) of three knee braces each worn 3 months by patients. Twenty-four patients with KOA were assigned in a randomized crossover trial a valgus three-point bending system brace (V3P-brace), an unloader brace with valgus and external rotation functions (VER-brace) and a stabilizing brace used after ligament injuries (ACL-brace). Functional questionnaires and gait assessment were carried out before and after each brace wear period of 3 months. A Friedman test was applied between brace wear diary recordings. Repeated measures analyses of variance contrasted the factors brace type (ACL, V3P, and VER), time (pre and post) and wear (without and with) on comfort, pain, function, and KAM. Brace usage was similar, but the V3P-brace was slightly less worn. Discomfort was significantly lowered with the VER-brace. All knee braces relieved pain and symptoms from 10% to 40%. KAM angular impulse was reduced with the three braces, but the VER-brace obtained the lowest relative reduction of 9%. The interaction between time and wear indicated that part of the KAM reduction with brace wear was maintained post treatment. All three knee braces have great benefits for pain and function among the medial KOA population. The VER-brace offers additional advantages on daily use, comfort and KAM, which could improve compliance to brace treatment.",2020,"KAM angular impulse was reduced with the three braces, but the VER-brace obtained the lowest relative reduction of 9%.","['Twenty-four patients with KOA', 'medial knee osteoarthritis']","['unloader brace with valgus and external rotation functions (VER-brace) and a stabilizing brace used after ligament injuries (ACL-brace', 'knee braces', 'point bending system brace (V3P-brace']","['pain and symptoms', 'Discomfort', 'Functional questionnaires and gait assessment', 'KAM angular impulse', 'usage, comfort, pain, and knee adduction moment (KAM', 'factors brace type (ACL, V3P and VER), time (pre and post) and wear (without and with) on comfort, pain, function and KAM']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0435001', 'cui_str': 'Ligament injury (disorder)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205133', 'cui_str': 'Bent (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",24.0,0.0183993,"KAM angular impulse was reduced with the three braces, but the VER-brace obtained the lowest relative reduction of 9%.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Robert-Lachaine', 'Affiliation': 'Département de Kinésiologie, Faculté de Médecine, Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Dessery', 'Affiliation': 'Département de Kinésiologie, Faculté de Médecine, Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Étienne L', 'Initials': 'ÉL', 'LastName': 'Belzile', 'Affiliation': 'Division de Chirurgie Orthopédique, CHU, Quebec City, QC, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Turmel', 'Affiliation': 'Division de Chirurgie Orthopédique, CHU, Quebec City, QC, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Corbeil', 'Affiliation': 'Département de Kinésiologie, Faculté de Médecine, Université Laval, Quebec City, QC, Canada.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24634']
3261,30950283,"Effects of morning vs. evening combined strength and endurance training on physical performance, sleep and well-being.","The aim of the present study was to examine how combined strength and endurance training in the morning and evening influences the adaptations in strength and endurance performance, perception of time management, psychological well-being and sleep. The combined training period lasted for 24 weeks and the participants were divided into the morning training (MG, n = 18), evening training (EG, n = 24) and control groups (CG, n = 10). Isometric leg press force (iLP), maximal oxygen consumption (VO 2 max), sleep behavior, fatigue, time management, motivation, self-esteem and health-related quality of life (HRQoL) were assessed. Morning to evening difference in iLP was observed in both MG and EG at Pre and Post, with higher force values in the evening, but not for VO 2 max. iLP force increased significantly in EG in the morning (p < 0.001) and evening (p = 0.010). VO 2 max increased in MG and EG both in the morning (both p < 0.001) and in the evening (MG: p < 0.001; EG: p = 0.003). Participants of the present study slept 7-8 h per night and the self-reported sleep duration, get-up time and the average time to go to bed were similar between the groups and did not change from Pre to Post. From HRQoL dimensions, the score for bodily pain decreased in MG (p = 0.029) and significant between-group differences were observed for Pre-Post changes in MG and EG (p = 0.001) as well as between MG and CG (p < 0.001). In vitality, a significant between-group difference was observed for Pre to Post changes in MG and EG (p = 0.014). Perception of time management decreased in EG (p = 0.042) but stayed unchanged for MG and CG. For the intrinsic motivation to participate, significant between-group differences were observed for MG and EG (p = 0.033) and between MG and CG (p = 0.032) for Pre to Post changes. Self-esteem improved in MG (p = 0.029) and EG (p = 0.024). The present combined strength and endurance training program performed in the morning and in the evening led to similar improvements in strength and endurance performance. Training in the morning or in the evening did not disrupt the already good sleep behavior and it was able to further increase the self-esteem. Although training in the morning hours may leave more time for free time activities or social life (i.e. family and friends) compared to the evening training, it might be more challenging to stay motivated to participate in prolonged training programs in the morning hours.",2019,Self-esteem improved in MG (p = 0.029) and EG (p = 0.024).,[],"['combined strength and endurance training', 'morning vs. evening combined strength and endurance training']","['Self-esteem', 'iLP', 'strength and endurance performance, perception of time management, psychological well-being and sleep', 'score for bodily pain', 'Isometric leg press force (iLP), maximal oxygen consumption (VO 2 max), sleep behavior, fatigue, time management, motivation, self-esteem and health-related quality of life (HRQoL', 'physical performance, sleep and well-being', 'sleep duration, get-up time and the average time to go to bed', 'strength and endurance performance', 'VO 2 max increased in MG and EG', 'iLP force']",[],"[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2607857'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",24.0,0.02318,Self-esteem improved in MG (p = 0.029) and EG (p = 0.024).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Küüsmaa-Schildt', 'Affiliation': 'a Neuromuscular Research Center, Biology of Physical Activity, Faculty of Sport and Health Sciences , University of Jyväskylä , Jyväskylä , Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Liukkonen', 'Affiliation': 'b Behavioral Sciences, Faculty of Sport and Health Sciences , University of Jyväskylä , Jyväskylä , Finland d.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Vuong', 'Affiliation': 'a Neuromuscular Research Center, Biology of Physical Activity, Faculty of Sport and Health Sciences , University of Jyväskylä , Jyväskylä , Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nyman', 'Affiliation': 'c Department of Cardiology , Central Hospital of Central Finland , Jyväskylä , Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'a Neuromuscular Research Center, Biology of Physical Activity, Faculty of Sport and Health Sciences , University of Jyväskylä , Jyväskylä , Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Häkkinen', 'Affiliation': 'c Department of Cardiology , Central Hospital of Central Finland , Jyväskylä , Finland.'}]",Chronobiology international,['10.1080/07420528.2019.1592184']
3262,32081690,Comparison of Clinical Outcomes of CO 2  Laser-Assisted Blepharoplasty Using Two Different Methods.,"PURPOSE


Numerous methods have been developed for blepharoplasty, including carbon dioxide (CO 2 ) laser-assisted blepharoplasty. Although the superiority of CO 2  laser compared with the scalpel for blepharoplasty has been proposed, to the best of our knowledge, no study has compared the clinical outcomes of blepharoplasty with the CO 2  laser alone versus the combined use of a scalpel and CO 2  laser.
PATIENTS AND METHODS


In the present randomized clinical trial, 21 healthy patients underwent bilateral upper eyelid blepharoplasty. For each patient, an initial skin incision was made using the CO 2  laser (setting, continuous emission; ultrapulse mode; 3 W of power) on 1 side and a scalpel on the other side. The remaining blepharoplasty steps were conducted using the CO 2  laser (setting, continuous emission; 9 W of power) in both groups. The patients were evaluated on postoperative days 1, 3, 7, 14, and 30 using the postoperative repair criteria, including edema and ecchymosis. The Manchester scar scale was used to evaluate the results at 60 days after surgery.
RESULTS


Our comparison of the 2 methods showed no significant differences at 1 month after surgery using the evaluation criteria. The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
CONCLUSIONS


In upper eyelid blepharoplasty, making an initial incision with a scalpel, followed by use of a laser provides advantages similar to those found by performing the entire procedure with a CO 2  laser alone.",2020,"The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
",['21 healthy patients underwent'],"['bilateral upper eyelid blepharoplasty', 'carbon dioxide (CO 2 ) laser-assisted blepharoplasty', 'CO 2  Laser-Assisted Blepharoplasty']","['scar index', 'Manchester scar scale', 'edema and ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure (body structure)'}, {'cui': 'C0197213', 'cui_str': 'Blepharoplasty'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",21.0,0.0189338,"The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Fallahi', 'Affiliation': 'Oral Maxillofacial Surgeon, Private Practice; Dental Research Center, Research Institute of Dental Sciences and School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Seied Omid', 'Initials': 'SO', 'LastName': 'Keyhan', 'Affiliation': 'Oral Maxillofacial Surgeon, National Advance Center for Craniomaxillofacial Reconstruction, Craniomaxillofacial Research Center, Tehran University of Medical Sciences; and Regenerative Medicine and Stem Cell Research Network, Shahaid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Niamtu', 'Affiliation': 'Oral Maxillofacial Surgeon, Private Practice; Fellow, American Academy of Cosmetic Surgery, Chicago, IL; and Diplomat, American Board of Cosmetic Facial Surgery, Philadelphia, PA.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Alikazemi', 'Affiliation': 'Oral Maxillofacial Surgeon and Assistance Professor, Department of Oral and Maxillofacial Surgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Raha', 'Initials': 'R', 'LastName': 'Habibagahi', 'Affiliation': 'PhD of Biomaterials, Orthodontic Research Center, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Raha2979@yahoo.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.015']
3263,31515418,"A randomised, controlled, observer-masked trial of corneal cross-linking for progressive keratoconus in children: the KERALINK protocol.","INTRODUCTION


The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients under 17 years old. KERALINK is a randomised controlled, observer-masked, multicentre trial in progressive keratoconus comparing epithelium-off CXL with standard care, including spectacles or contact lenses as necessary for best-corrected acuity.
METHODS AND ANALYSIS


A total of 30 participants will be randomised per group. Eligible participants aged 10-16 years with progressive keratoconus in one or both eyes will be recruited. Following randomisation, participants will be followed up 3-monthly for 18 months. The effect on progression will be determined by K 2  on corneal topography. The primary outcome measure is between-group difference in K 2  at 18 months adjusted for K 2  at baseline examination. Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events. Patient-reported effects will be explored by questionnaires.
ETHICS AND DISSEMINATION


Research Ethics Committee Approval was obtained on 30 June 2016 (ref: 14/LO/1937). Current protocol: V.5.0 (08/11/2017). Study findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


European Union clinial trials register (EudraCT) 2016-001460-11.",2019,"Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events.","['children', 'Eligible participants aged 10-16 years with progressive keratoconus in one or both eyes will be recruited', 'patients under 17 years old', '30 participants']","['corneal cross-linking (CXL', 'CXL with standard care, including spectacles or contact lenses']","['effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.366513,"Secondary outcomes are the effect of CXL on (1) keratoconus progression, (2) time to keratoconus progression, (3) visual acuity, (4) refraction, (5) apical corneal thickness and (6) adverse events.","[{'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dore', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Burr', 'Affiliation': ""School of Medicine, University of St Andrews, St. Andrew's, UK.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'Primary Care and Public Health Sciences, Kings College London, London, UK.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Raynor', 'Affiliation': 'Ophthalmology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Ophthalmology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Daniel F P', 'Initials': 'DFP', 'LastName': 'Larkin', 'Affiliation': 'NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, London, UK f.larkin@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2018-028761']
3264,32128593,The effects of digital cognitive behavioral therapy for insomnia on cognitive function: a randomized controlled trial.,"STUDY OBJECTIVES


We sought to examine the impact of digital cognitive behavioral therapy (dCBT) for insomnia on both self-reported cognitive impairment and objective cognitive performance.
METHODS


The Defining the Impact of Sleep improvement on Cognitive Outcomes (DISCO) trial was an online, two-arm, single-blind, randomized clinical trial of dCBT versus wait-list control. Participants were aged 25 years and older, met DSM-5 diagnostic criteria for insomnia disorder, and reported difficulties with concentration or memory. Assessments were carried out online at baseline, and 10 and 24 weeks post-randomization. The primary outcome measure was self-reported cognitive impairment, assessed with the British Columbia Cognitive Complaints Inventory (BC-CCI). Secondary outcomes included tests of cognitive performance, insomnia symptoms, cognitive failures, fatigue, sleepiness, depression, and anxiety.
RESULTS


Four hundred and ten participants with insomnia were recruited and assigned to dCBT (N = 205) or wait-list control (N = 205). At 10 weeks post-randomization the estimated adjusted mean difference for the BC-CCI was -3.03 (95% CI: -3.60, -2.47; p < 0.0001, d = -0.86), indicating that participants in the dCBT group reported less cognitive impairment than the control group. These effects were maintained at 24 weeks (d = -0.96) and were mediated, in part, via reductions in insomnia severity and increased sleep efficiency. Treatment effects in favor of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety. We found no between-group differences in objective tests of cognitive performance.
CONCLUSIONS


Our study shows that dCBT robustly decreases self-reported cognitive impairment at post-treatment and these effects are maintained at 6 months.",2020,"Treatment effects in favour of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety.","['Participants were aged 25 years and older, met DSM-5 diagnostic criteria for insomnia disorder and reported difficulties with concentration or memory', '410 participants with insomnia']","['digital cognitive behavioural therapy (dCBT', 'digital cognitive behavioural therapy', 'dCBT']","['insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety', 'cognitive impairment', 'tests of cognitive performance, insomnia symptoms, cognitive failures, fatigue, sleepiness, depression and anxiety', 'objective tests of cognitive performance', 'insomnia severity and increased sleep efficiency', 'cognitive function', 'self-reported cognitive impairment, assessed with the British Columbia Cognitive Complaints Inventory (BC-CCI']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",410.0,0.163297,"Treatment effects in favour of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety.","[{'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Madeleine E D', 'Initials': 'MED', 'LastName': 'Hurry', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': 'Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Marsden', 'Affiliation': 'Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Omlin', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amender', 'Initials': 'A', 'LastName': 'Juss', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Spiegelhalder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Bisdounis', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Annemarie I', 'Initials': 'AI', 'LastName': 'Luik', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Sexton', 'Affiliation': 'Oxford Centre for Human Brain Activity, Wellcome Centre for Integrative Neuroimaging, Department of Psychiatry, University of Oxford, Oxford, UK.'}]",Sleep,['10.1093/sleep/zsaa034']
3265,31387766,A randomized controlled trial of public messaging to promote safe firearm storage among U.S. military veterans.,"BACKGROUND


The objectives of this study were to determine whether short-term exposure to firearm safety messaging significantly improved (1) firearm storage practices, and (2) attitudes of safe firearm storage behaviors among U.S. veterans, a group at elevated risk for firearm suicide.
DESIGN


A three-arm, parallel-group RCT was conducted online in the U.S. nationwide from December 2015 to January 2016.
SETTING


A national random sample of U.S. veterans (N = 358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults. All study activities were administered online over a three-week study period.
INTERVENTION


Participants were randomized and exposed three times (once per week) to either (a) firearm safety message only (n = 115); (b) firearm safety and mental health promotion messages (n = 133); or (c) active control group exposed to mental health promotion message only (n = 110). Each message was less than two minutes long.
MEASURES


Assessments were completed at baseline (pre-randomization) and at end-of-trial. Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys. Linear mixed effect models with weighted generalized estimating equations were used to test for exposure effects. Analyses were conducted February 2018.
RESULTS


Analyses restricted to those with baseline firearm access (n = 195) identified no significant changes for intentions or safe storage practices across exposure groups. At baseline, participants' attitudes and beliefs were generally supportive of safe firearm storage. The Firearm Safety message yielded small increases in agreement with the concept that secure storage is ""important during emotional or stressful times"" (0.36; 95% CI = 0.08, 0.64). Other significant changes in awareness and beliefs were found, but across all study conditions.
CONCLUSION


Results reinforce the critical need for considerable research and testing prior to the widespread implementation of public messages to increase the likelihood for desired exposure effects.",2019,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","['U.S. military veterans', 'U.S. veterans, a group at elevated risk for firearm suicide', 'A national random sample of U.S. veterans (N\u202f=\u202f358) was recruited from the GfK KnowledgePanel, a probability-based internet panel representative of U.S. adults']","['public messaging', 'firearm safety message only (n\u202f=\u202f115); (b) firearm safety and mental health promotion messages (n\u202f=\u202f133); or (c) active control group exposed to mental health promotion message']","['awareness and beliefs', 'intentions or safe storage practices', 'awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016139', 'cui_str': 'Firearms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.0646168,"Changes in awareness of risk for injuries, attitudes/beliefs related to safe storage practices, behavioral intentions, and storage practices were measured using self-reported surveys.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karras', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Department of Psychiatry, University of Rochester, Rochester, NY, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA. Electronic address: Elizabeth.Karras@va.gov.'}, {'ForeName': 'Cara M', 'Initials': 'CM', 'LastName': 'Stokes', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Warfield', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'Barth', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bossarte', 'Affiliation': 'Center of Excellence for Suicide Prevention, Department of Veterans Affairs, Canandaigua VA, Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424, USA; Injury Control Research Center, West Virginia University, Morgantown, WV, USA; Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA; Department of Behavioral Medicine and Psychiatry, School of Medicine, West Virginia University, Morgantown, WV, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2019.03.001']
3266,31483191,Advance Care Planning to Improve End-of-Life Decision-Making Consistency between Older People and Their Surrogates in Taiwan.,"Background:  Surrogates often do not accurately predict older people's preferences about end-of-life (EOL) care. Few studies have examined the impact of advance care planning (ACP) on EOL decision-making consistency between older people and their surrogates, and these studies have yielded conflicting results.  Objectives:  To evaluate the effectiveness of ACP in improving EOL decision-making consistency between older people and their surrogates.  Design:  The intervention in this pre-post quasi-experimental design included an informative video, a brochure about ACP, and a guided discussion about EOL wishes.  Setting:  Two geriatric wards in a medical center in northern Taiwan.  Subjects:  One hundred eight participants, as 54 pairs of older people and their surrogates, were randomly assigned to either the experimental or control group. The experimental group received an intervention, while the control group received usual care.  Measurements:  Life-Support Preferences Questionnaire.  Results:  The intervention did not improve decision-making consistency between older people and their surrogates. This was the first time that most pairs discussed specific EOL decisions, so additional preparation may improve comfort with this topic. This study also found that some older people had difficulty concentrating on the educational brochure or understanding the related terms.  Conclusions:  Preparation for ACP discussion is needed for older people and their surrogates. Longer-term effects of ACP should be monitored because ACP interventions may have enhanced empathy between older people and their surrogates. Additionally, a culturally sensitive illustrated questionnaire that explains life-support preferences and ACP topics may improve communication between older people and their surrogates.",2020,Background:  Surrogates often do not accurately predict older people's preferences about end-of-life (EOL) care.,"['Subjects:  One hundred eight participants, as 54 pairs of older people and their surrogates', 'older people and their surrogates', 'Older People and Their Surrogates in Taiwan', 'Setting:  Two geriatric wards in a medical center in northern Taiwan']","['control group received usual care', 'ACP', 'advance care planning (ACP']",['decision-making consistency'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",108.0,0.0226876,Background:  Surrogates often do not accurately predict older people's preferences about end-of-life (EOL) care.,"[{'ForeName': 'Li-Shan', 'Initials': 'LS', 'LastName': 'Ke', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Mei-Jung', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chuan', 'Initials': 'HC', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Li-Hwa', 'Initials': 'LH', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0277']
3267,31792863,Doubling Hepatitis C Virus Screening in Primary Care Using Advanced Electronic Health Record Tools-A Non-Randomized Controlled Trial.,"BACKGROUND


Hepatitis C virus (HCV) infection is a major public health burden, affecting over 4 million people. The Centers for Disease Control and Prevention and the US Preventive Services Task Force guidelines recommend screening everyone born between 1945 and 1965, but screening rates remain low.
OBJECTIVE


To determine whether bulk ordering and electronic messaging to patients improves guideline-based HCV screening rates.
DESIGN


A non-randomized controlled trial of 1024 adults from November 2016 to March 2017.
PARTICIPANTS


Patients due for HCV screening with at least one primary care office visit in one of three primary care clinics and enrolled in the healthcare system's tethered personal health record (tPHR).
INTERVENTIONS


Control patients received normal care for HCV screening, consisting of passive HCV reminders to providers during face-to-face visits and passive HCV screening notification through the patient's tPHR. Intervention patients received normal care and also had HCV antibody tests ordered for them and customized messages sent through their tPHR inviting them to go directly to the lab for HCV screening over a 12-week period.
MAIN MEASURES


Percentage/number of patients receiving HCV antibody tests during the intervention period. Percentage/number of intervention group patients receiving HCV screening with other blood work.
KEY RESULTS


In the intervention group, 33% (168 of 514) completed HCV testing, compared with 19% (97 of 510) of controls (OR 1.7, 95% CI 1.2-2.1). Bulk lab ordering appeared to have a large impact while bulk messaging appeared to have a less significant role.
CONCLUSIONS


Leveraging population analytics and bulk ordering in an electronic health record with bulk messaging to a tPHR directly engages patients in blood screening tests and can significantly improve completion. This methodology has a broad range of applications including many recommended screening or disease-specific testing. This bulk ordering and direct-to-patient messaging approach improves patient screening while decreasing provider/staff work.
TRIAL REGISTRATION


MetroHealth IRB16-00776 (ClinicalTrials.gov).",2020,"In the intervention group, 33% (168 of 514) completed HCV testing, compared with 19% (97 of 510) of controls (OR 1.7, 95% CI 1.2-2.1).","['1024 adults from November 2016 to March 2017', ""Patients due for HCV screening with at least one primary care office visit in one of three primary care clinics and enrolled in the healthcare system's tethered personal health record (tPHR""]","['normal care and also had HCV antibody tests ordered for them and customized messages sent through their tPHR inviting them to go directly to the lab for HCV screening', ""Control patients received normal care for HCV screening, consisting of passive HCV reminders to providers during face-to-face visits and passive HCV screening notification through the patient's tPHR""]",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0577538', 'cui_str': 'Tethered (qualifier value)'}, {'cui': 'C0018739', 'cui_str': 'Personal Health Records'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0166049', 'cui_str': 'Hepatitis C Virus Antibodies'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}]",[],1024.0,0.196525,"In the intervention group, 33% (168 of 514) completed HCV testing, compared with 19% (97 of 510) of controls (OR 1.7, 95% CI 1.2-2.1).","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Hojat', 'Affiliation': 'Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Avery', 'Affiliation': 'Department of Medicine, The MetroHealth System, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greco', 'Affiliation': 'Department of Medicine, The MetroHealth System, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Kaelber', 'Affiliation': 'Department of Medicine, The MetroHealth System, Case Western Reserve University, Cleveland, OH, USA. David.kaelber@case.edu.'}]",Journal of general internal medicine,['10.1007/s11606-019-05536-z']
3268,31417102,A descriptive follow-up interview study assessing patient-centred outcomes: Salford Lung Study in Asthma (SLS Asthma).,"The Salford Lung Study in Asthma (SLS Asthma) was a multicentre, randomised, controlled, open-label trial that assessed initiating once-daily, single-inhaler fluticasone furoate/vilanterol (FF/VI) 100 μg/25 μg or 200 μg/25 μg versus continuing usual care. A subgroup (n = 400) from SLS Asthma was enrolled in this exploratory, interview-based follow-up study. Quantitative and qualitative data were collected via questionnaires. The primary objective was to capture patient-centred outcomes (symptom experience, quality of life [QoL], disease management behaviours) and patient experience. Secondary objectives were to assess the correlation of patient-reported outcomes with pre-defined variables from SLS Asthma (Asthma Control Test [ACT] score). The follow-up sample was representative of the SLS Asthma population; half reported asthma improvement during the study. Breathlessness was the most likely symptom to improve (47.8% of patients reported improvement). Most patients reported 'no change' in overall QoL (57.5%) and daily life domains (functioning 66.3%, activities 68.3%, relationships 86.8%, psychological 68.5%). Functioning was reported as the most frequently improved domain (29.8% of patients). Perceived improvement in asthma control (42.5%) and confidence (37.3%) was frequent. ACT responders (defined as patients achieving an ACT score ≥20 and/or an increase of ≥3 in ACT score from baseline at Week 52) were more likely to report asthma improvement (88.7% of patients reporting 'a lot' of improvement) than non-responders. Patients' asthma experiences generally improved during SLS Asthma. Clinical improvements were often associated with perceived improvement by patients, particularly among ACT responders.",2019,"Most patients reported 'no change' in overall QoL (57.5%) and daily life domains (functioning 66.3%, activities 68.3%, relationships 86.8%, psychological 68.5%).","['μg/25\u2009μg or 200', 'A subgroup (n\u2009=\u2009400) from SLS Asthma was enrolled in this exploratory, interview-based follow-up study', 'Asthma (SLS Asthma']",['fluticasone furoate/vilanterol (FF/VI) 100'],"['daily life domains', 'ACT score', 'Breathlessness', 'capture patient-centred outcomes (symptom experience, quality of life [QoL], disease management behaviours) and patient experience', 'overall QoL', 'SLS Asthma (Asthma Control Test [ACT] score']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0376636', 'cui_str': 'Disease Management'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",400.0,0.0674969,"Most patients reported 'no change' in overall QoL (57.5%) and daily life domains (functioning 66.3%, activities 68.3%, relationships 86.8%, psychological 68.5%).","[{'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Doward', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Svedsater', 'Affiliation': 'GlaxoSmithKline plc., Brentford, UK. henrik.x.svedsater@gsk.com.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Whalley', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Crawford', 'Affiliation': 'RTI Health Solutions, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leather', 'Affiliation': 'GlaxoSmithKline plc., Brentford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lay-Flurrie', 'Affiliation': 'GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bosanquet', 'Affiliation': 'Imperial College London, London, UK.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-019-0142-x']
3269,32066146,Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.,"Background


Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred.
Objective


To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo.
Design


Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333).
Setting


North America.
Participants


Adults with known cardiovascular disease and diabetes or metabolic syndrome.
Intervention


Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week.
Measurements


Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication.
Results


After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
Limitation


The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period.
Conclusion


Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased.
Primary Funding Source


National Institutes of Health.",2020,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","['6158 patients', 'patients without rheumatic disease who tolerated LD-MTX during an active run-in period', 'randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2', '2391 participants assigned to', 'Participants\n\n\nAdults with known cardiovascular disease and diabetes or metabolic syndrome']","['placebo', '\n\n\nLow-dose methotrexate (LD-MTX', 'LD-MTX', 'Low-Dose Methotrexate', 'LD-MTX versus placebo', 'folic acid']","['increased risk for skin cancer', 'Renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]",6158.0,0.678699,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Karlson', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Barbhaiya', 'Affiliation': 'Hospital for Special Surgery, New York, New York (M.B.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Aruna D', 'Initials': 'AD', 'LastName': 'Pradhan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Hammond', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Deepak A', 'Initials': 'DA', 'LastName': 'Rao', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Ritter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sparks', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Kathleen M M', 'Initials': 'KMM', 'LastName': 'Vanni', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-3369']
3270,32115662,Effects of exercise training combined with psychological intervention compared to exercise training alone in prediabetes subjects.,"BACKGROUND


Prior research has confirmed the efficacy of exercise training (ET) in patients with prediabetes. However, whether the effectiveness of a combination of exercise and psychological intervention (EP) is better than ET alone in prediabetes in terms of physiological function, psychological status and glycometabolism has rarely been investigated.
METHODS


Forty newly diagnosed prediabetes patients (65.3 ± 8.1 years) took part in the study. Subjects were divided into a pure ET group and a combined EP group. Interventions were conducted in 40-50-min sessions twice weekly for 32 weeks. Physiological, psychological and biochemical indicator measurements were taken after pre-, mid- and post-interventions, respectively.
RESULTS


The main finding confirmed a significant improvement in systolic blood pressure, diastolic blood pressure (DBP) and heart rate, high-density lipoprotein, fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c) from pre- to mid- and post-test differentially in both groups (P < 0.05) by post hoc analyses. The EP group has a greater magnitude of improvement of DBP than the ET group. Significant differences were observed in FPG at mid-intervention and total cholesterol at post-intervention between the ET and EP groups. Self-Rating Anxiety Scale (SAS) scores of EP group were significantly less than ET group after post-intervention.
CONCLUSION


Our results suggest that EP might be a promising method lead to more apparent long-term effects on glycometabolism and psychological status for prediabetes patients. Other domains were improved by both interventions, but no typical pattern could be identified. Its underlying mechanisms need further study, and directions for future research are suggested.",2020,Significant differences were observed in FPG at mid-intervention and total cholesterol at post-intervention between the ET and EP groups.,"['prediabetes patients', 'prediabetes subjects', 'patients with prediabetes', 'Forty newly diagnosed prediabetes patients (65.3\xa0±\xa08.1\xa0years) took part in the study']","['exercise training alone', 'exercise and psychological intervention (EP', 'exercise training (ET', 'exercise training combined with psychological intervention']","['Self-Rating Anxiety Scale (SAS) scores', 'Physiological, psychological and biochemical indicator measurements', 'DBP', 'FPG at mid-intervention and total cholesterol', 'systolic blood pressure, diastolic blood pressure (DBP) and heart rate, high-density lipoprotein, fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",40.0,0.017299,Significant differences were observed in FPG at mid-intervention and total cholesterol at post-intervention between the ET and EP groups.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Siyu', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qun', 'Affiliation': 'Shanghai Dongfang Hospital, Shanghai 200120, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Hua', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Yibiao', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Wenping', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'She', 'Initials': 'S', 'LastName': 'Qian', 'Affiliation': 'Health Service Center of Gaoqiao Community, Pudong New Area, Shanghai 200137, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Bo', 'Affiliation': 'Shanghai Dongfang Hospital, Shanghai 200120, China.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Xiaonan', 'Affiliation': 'Shanghai Pudong New Area Center for Disease Control and Prevention, Pudong Institute of Preventive Medicine, Fudan University, Shanghai 200136, China.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdaa024']
3271,32123978,Patient-Reported Outcomes and Long-Term Results of a Randomized Controlled Trial Comparing Single-Port Versus Conventional Laparoscopic Inguinal Hernia Repair.,"BACKGROUND


Surgical techniques for inguinal hernia repair have evolved rapidly from open methods to conventional laparoscopic totally extra-peritoneal (CTEP) and recently single-port TEP (STEP). As there is currently no randomized controlled trial (RCT) reporting long-term patient-reported outcomes between CTEP and STEP, we reviewed patients who were randomized to CTEP or STEP 5 years after surgery.
METHODS


Telephone interviews were administered to patients with primary unilateral inguinal hernia recruited for the RCT comparing CTEP and STEP in 2011. The modified Body Image Questionnaire was used to measure long-term patient-reported outcomes.
RESULTS


Forty-two out of forty-nine of the STEP group and forty-one out of fifty of the CTEP group responded to phone interviews. Median follow-up time, demographic data and clinical outcomes were comparable between both groups. The Body Image Score (5-20: 5-least dissatisfied, 20-most dissatisfied; BIS score ± SD, STEP vs. CTEP, 5.33 ± 0.90 vs. 7.17 ± 1.87, p < 0.001) and Cosmetic Score (2-20: 2-least satisfied, 20-most satisfied; CS score ± SD, STEP vs. CTEP, 19.05 ± 1.31 vs. 15.87 ± 1.57, p < 0.001) were superior in the STEP group. Similarly, self-reported scar perception (1-cannot be seen, 2-can barely be seen, 3-visible; scar perception score ± SD, STEP vs. CTEP, 1.29 ± 0.51 vs. 2.55 ± 0.64, p < 0.001) and overall experience score (1-least satisfied, 10-most satisfied; overall satisfaction score ± SD, STEP vs. CTEP, 9.57 ± 0.67 vs. 8.22 ± 0.94, p < 0.001) were superior in the STEP group.
CONCLUSION


Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group. STEP should be strongly considered in patients who are concerned about long-term cosmetic outcomes and should be offered if surgical expertise is available. Trial registration NCT02302937.",2020,"CONCLUSION


Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group.","['Telephone interviews were administered to patients with primary unilateral inguinal hernia recruited for the RCT comparing CTEP and STEP in 2011', 'Forty-two out of forty-nine of the STEP group and forty-one out of fifty of the']","['Single-Port Versus Conventional Laparoscopic Inguinal Hernia Repair', 'CTEP', 'conventional laparoscopic totally extra-peritoneal (CTEP']","['Cosmetic Score', 'superior cosmetic and satisfaction scores', 'overall experience score', 'scar perception', 'Body Image Score', 'Median follow-up time, demographic data and clinical outcomes']","[{'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}]","[{'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.160414,"CONCLUSION


Patients who underwent STEP reported superior cosmetic and satisfaction scores and comparable surgical outcomes 5 years after surgery compared to the CTEP group.","[{'ForeName': 'Daryl Kai Ann', 'Initials': 'DKA', 'LastName': 'Chia', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lomanto', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Wijerathne', 'Affiliation': 'Department of Surgery, University Surgical Cluster, National University Health System, 1E Kent Ridge Road, Singapore, 119228, Singapore. sujithwijerathne@gmail.com.'}]",World journal of surgery,['10.1007/s00268-020-05443-z']
3272,32111073,"Expression of MMP-2, MMP-9, and NGAL in Tissue and Serum of Patients with Vascular Aneurysms and Their Modulation by Statin Treatment: A Pilot Study.","BACKGROUND


Matrix metalloproteinases (MMPs) are involved in vascular wall degradation, and drugs able to modulate MMP activity can be used to prevent or treat aneurysmal disease. In this study, we evaluated the effects of statins on MMP-2, MMP-9, and neutrophil gelatinase-associated lipocalin (NGAL) in both plasma and tissue in patients with aneurysmal disease.
METHODS


We performed a prospective, single-blind, multicenter, control group clinical drug trial on 184 patients of both sexes >18 years old with a diagnosis of arterial aneurysmal disease. Enrolled patients were divided into two groups: Group I under statin treatment and Group II not taking statins. In addition, 122 patients without aneurysmal disease and under statin treatment were enrolled as a control group (Group III). The expression of MMPs and NGAL in plasma was evaluated using ELISA, while their expression in endothelial tissues was evaluated using Western blot.
RESULTS


The ELISA test revealed greater plasma levels ( p  < 0.01) of MMPs and NGAL in Groups I and II vs. Group III. Western blot analysis showed higher expression ( p  < 0.01) of MMPs and NGAL in Group II vs. Group I, and this increase was significantly higher ( p  < 0.01) in patients treated with low potency statins compared to high potency ones.
CONCLUSIONS


MMPs and NGAL seem to play a major role in the development of aneurysms, and their modulation by statins suggests that these drugs could be used to prevent arterial aneurysmal disease.",2020,The ELISA test revealed greater plasma levels ( p  < 0.01) of MMPs and NGAL in Groups I and II vs. Group III.,"['patients with aneurysmal disease', '184 patients of both sexes >18 years old with a diagnosis of arterial aneurysmal disease', '122 patients without aneurysmal disease and under statin treatment were enrolled as a control group (Group III', 'Patients with Vascular Aneurysms and Their Modulation by Statin Treatment']",['statin treatment and Group II not taking statins'],"['MMP-2, MMP-9, and neutrophil gelatinase-associated lipocalin (NGAL', 'plasma levels', 'expression of MMPs and NGAL in plasma', 'Expression of MMP-2, MMP-9, and NGAL in Tissue and Serum', 'higher expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439651', 'cui_str': 'Aneurysmal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",184.0,0.0136053,The ELISA test revealed greater plasma levels ( p  < 0.01) of MMPs and NGAL in Groups I and II vs. Group III.,"[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Cione', 'Affiliation': 'Department of Pharmacy, Health and Nutritional Sciences, Department of Excellence 2018-2022, University of Calabria, 87036 Rende (CS), Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Piegari', 'Affiliation': 'Department of Experimental Medicine, Section of Pharmacology, University of Campania ""Luigi Vanvitelli"", 80138 Napoli, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gallelli', 'Affiliation': 'Unit of Vascular Surgery, Department of Surgery, ""Pugliese Ciaccio"" Hospital, 88100 Catanzaro, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Caroleo', 'Affiliation': 'Department of Pharmacy, Health and Nutritional Sciences, Department of Excellence 2018-2022, University of Calabria, 87036 Rende (CS), Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Lamirata', 'Affiliation': 'Department of Experimental Medicine, University of Catanzaro, and Vascular Surgery Unit, 88100 Mater Domini Hospital, 88100 Catanzaro, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Curcio', 'Affiliation': 'Department of Experimental Medicine, University of Catanzaro, and Vascular Surgery Unit, 88100 Mater Domini Hospital, 88100 Catanzaro, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Colosimo', 'Affiliation': 'National Institution of Social Insurance, Department of Medical Law, 88100 Catanzaro, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cannataro', 'Affiliation': 'Department of Pharmacy, Health and Nutritional Sciences, Department of Excellence 2018-2022, University of Calabria, 87036 Rende (CS), Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ielapi', 'Affiliation': 'Department of public Health and Infectious Disease, ""Sapienza"" University of Rome 5, 00185 Roma, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Colosimo', 'Affiliation': 'Unit of Microbiology and Virology, ""Pugliese Ciaccio"" Hospital, 88100 Catanzaro, Italy.'}, {'ForeName': 'Stefano de', 'Initials': 'S', 'LastName': 'Franciscis', 'Affiliation': 'Department of Experimental Medicine, University of Catanzaro, and Vascular Surgery Unit, 88100 Mater Domini Hospital, 88100 Catanzaro, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gallelli', 'Affiliation': 'Department of Health Sciences, University of Catanzaro, and Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, 88100 Catanzaro, Italy.'}]",Biomolecules,['10.3390/biom10030359']
3273,31387385,Budget Impact of Improved Diabetes Management by Utilization of Glucose Meters With a Color-Range Indicator-Comparison of Five European Healthcare Systems.,"BACKGROUND AND AIM


Costs for the treatment of diabetes and its comorbidities are a major international issue. A recent randomized clinical trial showed that the introduction of color range indicator (CRI)-based glucose meters (GMs) positively affects the HbA1c of patients with type 1 and type 2 diabetes, when compared to GMs without a CRI. This budget impact analysis aimed to translate this beneficial effect of CRI-based GMs, OneTouch Verio Flex and OneTouch Verio, into potential monetary impact for the healthcare systems of five European countries, Germany, Spain, Italy, France, and the United Kingdom.
MATERIAL AND METHODS


Data from a randomized controlled trial, evaluating the effect of CRI-based GMs, were used to estimate the ten-year risk of patients for fatal myocardial infarction (MI) as calculated by the UK Prospective Diabetes Study (UKPDS) risk engine. On the basis of assessed risks for MI, the potential monetary impact for the healthcare systems in five European countries was modeled.
RESULTS


Based on a mean HbA1c reduction of 0.36%, as demonstrated in a randomized controlled trial, the UKPDS risk engine estimated a reduction of 2.4% of the ten-year risk of patients for fatal MI. When applied to our economic model, substantial potential cost savings for the healthcare systems of five European countries were calculated: €547 472 (France), €9.0 million (Germany), €6.0 million (Italy), €841 799 (Spain), and €421 069 (United Kingdom) per year.
CONCLUSION


Improving metabolic control in patients with diabetes by the utilization of CRI-based GMs may have substantial positive effects on the expenditure of the healthcare systems of several European countries.",2020,"When applied to our economic model, substantial potential cost savings for the healthcare systems of five European countries were calculated: €547 472 (France), €9.0 million (Germany), €6.0 million (Italy), €841 799 (Spain), and €421 069 (United Kingdom) per year.
","['patients for fatal myocardial infarction (MI) as calculated by the UK Prospective Diabetes Study (UKPDS) risk engine', 'five European countries were calculated: €547 472 (France), €9.0 million (Germany), €6.0 million (Italy), €841 799 (Spain), and €421 069 (United Kingdom) per year', 'patients with diabetes']","['CRI-based GMs', 'color range indicator (CRI)-based glucose meters (GMs']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",[],,0.0476792,"When applied to our economic model, substantial potential cost savings for the healthcare systems of five European countries were calculated: €547 472 (France), €9.0 million (Germany), €6.0 million (Italy), €841 799 (Spain), and €421 069 (United Kingdom) per year.
","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Fritzen', 'Affiliation': 'Sciarc GmbH, Baierbrunn, Germany.'}, {'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Basinska', 'Affiliation': 'Sciarc GmbH, Baierbrunn, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Stautner', 'Affiliation': 'Sciarc GmbH, Baierbrunn, Germany.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Braun', 'Affiliation': 'Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München, Germany.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Rubio-Almanza', 'Affiliation': 'Endocrinology and Nutrition Department Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolucci', 'Affiliation': 'Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kennon', 'Affiliation': 'FRCP, Diabetes Centre, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vergès', 'Affiliation': 'Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition, Centre Hospitalier Universitaire Dijon Bourgogne, France.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Hosny', 'Affiliation': 'LifeScan GmbH, Dubai, United Arab Emirates.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schnell', 'Affiliation': 'Sciarc GmbH, Baierbrunn, Germany.'}]",Journal of diabetes science and technology,['10.1177/1932296819864665']
3274,32092140,A phase 2 PK/PD study of andexanet alfa for reversal of rivaroxaban and edoxaban anticoagulation in healthy volunteers.,"As with any anticoagulant, factor Xa (FXa) inhibitors are associated with a risk of major bleeding. Andexanet alfa is a recombinant modified human FXa lacking enzymatic activity, developed for reversal of FXa inhibitor-induced anticoagulation. In two phase 2, randomized, double-blind, placebo-controlled, single-center studies, different regimens of andexanet alfa were administered to healthy volunteers after therapeutic anticoagulation with rivaroxaban or edoxaban, and multiple anticoagulation reversal and safety end points were evaluated. Andexanet alfa rapidly and effectively reversed anticoagulation with both rivaroxaban and edoxaban. Within 2 minutes after bolus, anti-FXa activity decreased significantly, with maximum decreases of ≈93% (P < .05) and ≈82% (P < .05), respectively, compared with placebo. The stoichiometric ratios of andexanet alfa:total anticoagulant at maximum reversal of anti-FXa activity ranged from 1:1 to 1.3:1 for rivaroxaban and 1.41:1 to 2.58:1 for edoxaban. Sustained normalization of thrombin generation for ≈2 hours and sustained decrease in unbound anticoagulant (maximum ≈80%) for up to ≈4 hours following completion of andexanet alfa administration, compared with placebo, were observed when andexanet was administered as a bolus or as a bolus followed by continuous infusion. Andexanet alfa was well tolerated, and there were no serious adverse events or thrombotic events. Andexanet alfa has been approved in the United States and Europe for reversal of anticoagulation in patients treated with rivaroxaban or apixaban who experience life-threatening or uncontrolled bleeding. These studies were registered with clinicaltrials.gov (#NCT03578146 and #NCT03551743).",2020,"Sustained normalization of thrombin generation for ≈2 hours and sustained decrease in unbound anticoagulant (maximum ≈80%) for up to ≈4 hours following completion of andexanet alfa administration, compared with placebo, were observed when andexanet was administered as a bolus or as a bolus followed by continuous infusion.","['healthy volunteers after therapeutic anticoagulation with', 'healthy volunteers', 'patients treated with rivaroxaban or apixaban who experience life-threatening or uncontrolled bleeding']","['Andexanet alfa', 'edoxaban', 'placebo', 'andexanet alfa', 'rivaroxaban or edoxaban', 'rivaroxaban and edoxaban', 'rivaroxaban and edoxaban anticoagulation', 'anticoagulant, factor Xa (FXa) inhibitors', 'rivaroxaban']","['stoichiometric ratios of andexanet alfa:total anticoagulant at maximum reversal of anti-FXa activity', 'anti-FXa activity', 'thrombin generation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C4079904', 'cui_str': 'coagulation factor Xa (recombinant), inactivated'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C4553708', 'cui_str': 'Factor Xa inhibitor'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4079904', 'cui_str': 'coagulation factor Xa (recombinant), inactivated'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]",,0.237047,"Sustained normalization of thrombin generation for ≈2 hours and sustained decrease in unbound anticoagulant (maximum ≈80%) for up to ≈4 hours following completion of andexanet alfa administration, compared with placebo, were observed when andexanet was administered as a bolus or as a bolus followed by continuous infusion.","[{'ForeName': 'Genmin', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': 'Portola Pharmaceuticals, Inc., South San Francisco, CA.'}, {'ForeName': 'Pamela B', 'Initials': 'PB', 'LastName': 'Conley', 'Affiliation': 'Portola Pharmaceuticals, Inc., South San Francisco, CA.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Leeds', 'Affiliation': 'Portola Pharmaceuticals, Inc., South San Francisco, CA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Karbarz', 'Affiliation': 'Portola Pharmaceuticals, Inc., South San Francisco, CA.'}, {'ForeName': 'Gallia G', 'Initials': 'GG', 'LastName': 'Levy', 'Affiliation': 'Portola Pharmaceuticals, Inc., South San Francisco, CA.'}, {'ForeName': 'Vandana S', 'Initials': 'VS', 'LastName': 'Mathur', 'Affiliation': 'Mathur Consulting, San Francisco, CA; and.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Portola Pharmaceuticals, Inc., South San Francisco, CA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Crowther', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Curnutte', 'Affiliation': 'Portola Pharmaceuticals, Inc., South San Francisco, CA.'}]",Blood advances,['10.1182/bloodadvances.2019000885']
3275,31840247,High-definition transcranial direct current stimulation dissociates fronto-visual theta lateralization during visual selective attention.,"KEY POINTS


Visual attention involves discrete multispectral oscillatory responses in visual and 'higher-order' prefrontal cortices. Prefrontal cortex laterality effects during visual selective attention are poorly characterized. High-definition transcranial direct current stimulation dynamically modulated right-lateralized fronto-visual theta oscillations compared to those observed in left fronto-visual pathways. Increased connectivity in right fronto-visual networks after stimulation of the left dorsolateral prefrontal cortex resulted in faster task performance in the context of distractors. Our findings show clear laterality effects in theta oscillatory activity along prefrontal-visual cortical pathways during visual selective attention.
ABSTRACT


Studies of visual attention have implicated oscillatory activity in the recognition, protection and temporal organization of attended representations in visual cortices. These studies have also shown that higher-order regions such as the prefrontal cortex are critical to attentional processing, but far less is understood regarding prefrontal laterality differences in attention processing. To examine this, we selectively applied high-definition transcranial direct current stimulation (HD-tDCS) to the left or right dorsolateral prefrontal cortex (DLPFC). We predicted that HD-tDCS of the left versus right prefrontal cortex would differentially modulate performance on a visual selective attention task, and alter the underlying oscillatory network dynamics. Our randomized crossover design included 27 healthy adults that underwent three separate sessions of HD-tDCS (sham, left DLPFC and right DLPFC) for 20 min. Following stimulation, participants completed an attention protocol during magnetoencephalography. The resulting oscillatory dynamics were imaged using beamforming, and peak task-related neural activity was subjected to dynamic functional connectivity analyses to evaluate the impact of stimulation site (i.e. left and right DLPFC) on neural interactions. Our results indicated that HD-tDCS over the left DLPFC differentially modulated right fronto-visual functional connectivity within the theta band compared to HD-tDCS of the right DLPFC and further, specifically modulated the oscillatory response for detecting targets among an array of distractors. Importantly, these findings provide network-specific insight into the complex oscillatory mechanisms serving visual selective attention.",2020,Increased connectivity in right fronto-visual networks after stimulation of the left DLPFC resulted in faster task performance in the context of distractors.,['27 healthy adults'],"['high-definition transcranial direct-current stimulation (HD-tDCS', 'HD-tDCS (sham, left- and right-DLPFC', 'attention paradigm during magnetoencephalography (MEG']","['faster task performance', 'HD-tDCS dynamically modulated right-lateralized fronto-visual theta oscillations', 'right fronto-visual functional connectivity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",27.0,0.0470895,Increased connectivity in right fronto-visual networks after stimulation of the left DLPFC resulted in faster task performance in the context of distractors.,"[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Spooner', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Eastman', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rezich', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Tony W', 'Initials': 'TW', 'LastName': 'Wilson', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}]",The Journal of physiology,['10.1113/JP278788']
3276,32112166,A Comparison of Intrathecal and Intravenous Morphine for Analgesia After Hepatectomy: A Randomized Controlled Trial.,"BACKGROUND


Effective analgesia is essential for patient recovery after liver resection. This study aimed to evaluate the effects of the addition of preoperative intrathecal morphine to multimodal intravenous analgesia in patients undergoing liver resection.
METHODS


In this single-blind randomized controlled trial, patients undergoing liver resection were randomly assigned to the patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine groups. All patients received acetaminophen and dexketoprofen. The primary outcome was pain severity at rest over three postoperative days, assessed using the numerical rating scale (NRS).
RESULTS


The study included 36 patients (18 in each group). The mean maximum daily NRS scores over the first three postoperative days in the ITM-IV and IV groups were 1.3, 1.1, and 0.3 and 1.6, 1.1, and 0.7, respectively (p = 0.580). No differences were observed in pain severity while coughing, with corresponding scores of 2.8, 2.1, and 1.1, respectively, in the ITM-IV group and 2.3, 2.2, and 1.5, respectively, in the IV group (p = 0.963). Proportions of patients reporting clinically significant pain at rest and while coughing were 11.1% and 44.4%, respectively, in the ITM-IV group, and 16.7% and 44.4%, respectively, in the IV group (both p > 0.999). Cumulative morphine doses in the ITM-IV and IV groups were 26 mg and 17 mg, respectively (p = 0.257). Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
CONCLUSIONS


Preoperative intrathecal morphine administration provides no benefits to multimodal analgesia in patients undergoing liver resection.
TRIAL REGISTRATION NUMBER


Clinicaltrial.gov Identifier: NCT03620916.",2020,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","['patients undergoing liver resection', 'patient recovery after liver resection', '36 patients (18 in each group']","['patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine', 'acetaminophen and dexketoprofen', 'morphine', 'Intrathecal and Intravenous Morphine', 'preoperative intrathecal morphine']","['pain severity while coughing', 'sedation grade', 'pain severity', 'time to mobilization', 'solid food intake', 'mean maximum daily NRS scores', 'morbidity', 'pain at rest and while coughing', 'Analgesia', 'numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0453855', 'cui_str': 'Solid food (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0222045'}]",36.0,0.200098,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402).
","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Niewiński', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Figiel', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland. w.figiel@yahoo.es.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Dec', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Morawski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}]",World journal of surgery,['10.1007/s00268-020-05437-x']
3277,32112263,"Effects of contact-based, short-term anti-stigma training for medical students : Results from a randomized controlled trial.","BACKGROUND


Mental health stigma (MHS) places a burden on those affected that far exceeds psychosocial harms. Contact-based anti-stigma work has been found effective for several target groups. For medical students however, its efficacy remains unclear.
AIM


The purpose of this study was to examine the efficacy of contact-based, trialogic anti-stigma training for medical students.
METHODS


A randomized controlled trial (RCT) was conducted, controlling for standard clinical placement in psychiatry. External validity was maximized by including all students (n = 204) who started their 6‑week obligatory psychiatry course during the study period between March and July 2018. Assessments were conducted at the beginning of each of the two covered terms and immediately postintervention.
RESULTS


Students who received the anti-stigma training displayed significantly less stigmatizing attitudes after the intervention, measured using the MICA (Mental Illness-Clinicians' Attitudes) scale as primary outcome. Analogous findings were noted for social distance and stereotypes, whereas these could not be observed for emotional reactions. All significant changes were independent of gender and age.
CONCLUSION


The positive results underpin the research in this field and point towards the inclusion of comparable interventions in regular student curricula. Given the limitation of a missing late follow-up, however, further research regarding the persistence of stigma reduction is needed.",2020,"RESULTS


Students who received the anti-stigma training displayed significantly less stigmatizing attitudes after the intervention, measured using the MICA (Mental Illness-Clinicians' Attitudes) scale as primary outcome.","['all students (n\u202f=\u2009204) who started their 6‑week obligatory psychiatry course during the study period between March and July 2018', 'medical students ', 'medical students']","['contact-based, short-term anti-stigma training', 'contact-based, trialogic anti-stigma training']","['External validity', ""MICA (Mental Illness-Clinicians' Attitudes) scale"", 'social distance and stereotypes', 'stigmatizing attitudes']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0066503', 'cui_str': 'Mica'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0222045'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]",,0.0557419,"RESULTS


Students who received the anti-stigma training displayed significantly less stigmatizing attitudes after the intervention, measured using the MICA (Mental Illness-Clinicians' Attitudes) scale as primary outcome.","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Wechsler', 'Affiliation': 'Centre for Psychosocial Medicine, University Hospital Hamburg Eppendorf, Hamburg, Germany. dominik.wechsler@gmx.de.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schomerus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Candelaria', 'Initials': 'C', 'LastName': 'Mahlke', 'Affiliation': 'Centre for Psychosocial Medicine, University Hospital Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bock', 'Affiliation': 'Centre for Psychosocial Medicine, University Hospital Hamburg Eppendorf, Hamburg, Germany.'}]","Neuropsychiatrie : Klinik, Diagnostik, Therapie und Rehabilitation : Organ der Gesellschaft Osterreichischer Nervenarzte und Psychiater",['10.1007/s40211-020-00337-x']
3278,31209428,[Anti-Müllerian hormone as a new marker of the ovarian reserve function preservation by goserelin during (neo)adjuvant chemotherapy for young breast cancer patients].,"OBJECTIVE


To observe the dynamic change of anti-Müllerian hormone (AMH) in 1 year after chemotherapy which is the best biochemical marker of ovarian reserve in reproductive medicine setting and to evaluate the effect of gonadotropin-releasing hormone agonist (GnRHa)goserelin to prevent ovarian reserve function during (neo)adjuvant chemotherapy for young breast cancer patients.
METHODS


Between December 2015 and June 2017, 101 breast cancer patients of age ≤ 45 years with stages I to III had been enrolled. The patients were assigned without interference to receive either (neo) adjuvant chemotherapy with goserelin (goserelin group) or without goserelin (chemotherapy group) as their own selection. AMH and menstrual status were evaluated before, during and 0.5 year, 1 year after chemotherapy. Primary end point was the incidence of low AMH value (<0.4 μg/L) at the end of 1 year. Secondary end point was the incidence of amenorrhea (the absence of menses in the preceding 12 months after assignment).
RESULTS


In the study, 51 patients chose to join the chemotherapy group, while the other 50 patients selected goserelin to preserve their ovarian reserve function. More unmarried or childless, hormone receptors negative,receiving breast conservation therapy patients with earlier stage selected goserelin before chemotherapy. The incidence of low AMH value was significantly higher in chemotherapy group than in goserelin group (74.5% vs. 38.0%, P<0.001) in 1 year after chemotherapy. The incidence of amenorrhea was consistent with AMH (56.9% vs. 24.0%, P=0.001). And more patients' menstruation (78.9% vs. 54.5%) and AMH value (71.0% vs. 53.8%) recovered in goserelin group within 6 months after chemotherapy. In subgroup analysis, AMH and menstruation seemingly recovered more in goserelin group independent of age, chemotherapy regimen and use of tamoxifen. Especially, AMH value of 36.4% (8/22) patients in chemotherapy group and 18.4% (7/38) patients in goserelin group still maintained low level (<0.4 μg /L) although their menstruation had recovered 1 year after chemotherapy. In addition, 41 patients (20 patients in chemotherapy group, 21 patients in goserelin group) could be evaluated for the dynamic change of AMH and menstrual status during chemotherapy. The mean level of AMH in chemotherapy group declined rapidly to very low level before the 3rd cycle, while 70% of the patients kept presence of menstruation. At the same time, the mean level of AMH in goserelin group was still above 0.4 μg /L, but all of the patients had menopause.
CONCLUSION


Our study has offered evidence that Goserelin with chemotherapy could protect against ovarian reserve failure for young breast cancer patients, now that more patients' AMH value recovered earlier who had selected co-treatment. AMH may be a more precise marker than menstrual status to clinically evaluate ovarian reserve function pre-, during and post- chemotherapy.",2019,"The incidence of low AMH value was significantly higher in chemotherapy group than in goserelin group (74.5% vs. 38.0%, P<0.001) in 1 year after chemotherapy.","['≤ 45 years with stages I to III had been enrolled', 'Between December 2015 and June 2017, 101 breast cancer patients of age', '41 patients (20 patients in chemotherapy group, 21 patients in', '51 patients chose to join the chemotherapy group, while the other 50 patients selected', 'young breast cancer patients']","['Goserelin with chemotherapy', 'goserelin during (neo)adjuvant chemotherapy', 'anti-Müllerian hormone (AMH', 'interference to receive either (neo) adjuvant chemotherapy with goserelin (goserelin group) or without goserelin (chemotherapy', 'tamoxifen', 'goserelin', 'gonadotropin-releasing hormone agonist (GnRHa)goserelin']","['AMH value', 'AMH and menstrual status', 'ovarian reserve function', 'incidence of amenorrhea (the absence of menses', 'incidence of low AMH value', ""patients' menstruation"", 'mean level of AMH', 'incidence of amenorrhea', 'dynamic change of AMH and menstrual status']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",101.0,0.0611215,"The incidence of low AMH value was significantly higher in chemotherapy group than in goserelin group (74.5% vs. 38.0%, P<0.001) in 1 year after chemotherapy.","[{'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Peking University People's Hospital, Beijing 100044, China.""}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,['10.19723/j.issn.1671-167X.2019.03.024']
3279,31682584,Effects of a Smartphone-Based Approach-Avoidance Intervention on Chocolate Craving and Consumption: Randomized Controlled Trial.,"BACKGROUND


Repeatedly pushing high-calorie food stimuli away based on joystick movements has been found to reduce approach biases toward these stimuli. Some studies also found that such avoidance training reduced consumption of high-calorie foods.
OBJECTIVE


This study aimed to test effects of a smartphone-based approach-avoidance intervention on chocolate craving and consumption, to make such interventions suitable for daily use.
METHODS


Within a 10-day period, regular chocolate eaters (n=105, 86% female) performed five sessions during which they continuously avoided (ie, swiped upward) chocolate stimuli (experimental group, n=35), performed five sessions during which they approached and avoided chocolate stimuli equally often (placebo control group, n=35), or did not perform any training sessions (inactive control group, n=35). Training effects were measured during laboratory sessions before and after the intervention period and further continuously through daily ecological momentary assessment.
RESULTS


Self-reported chocolate craving and consumption as well as body fat mass significantly decreased from pre- to postmeasurement across all groups. Ecological momentary assessment reports evidenced no differences in chocolate craving and consumption between intervention days and rest days as a function of the group.
CONCLUSIONS


A smartphone-based approach-avoidance training did not affect eating-related and anthropometric measures over and above measurement-based changes in this study. Future controlled studies need to examine whether other techniques of modifying food approach tendencies show an add-on benefit over conventional, monitoring-based intervention effects.
TRIAL REGISTRATION


AsPredicted 8203; https://aspredicted.org/pt9df.pdf.",2019,"Ecological momentary assessment reports evidenced no differences in chocolate craving and consumption between intervention days and rest days as a function of the group.
",[],"['five sessions during which they continuously avoided (ie, swiped upward) chocolate stimuli (experimental group, n=35), performed five sessions during which they approached and avoided chocolate stimuli equally often (placebo control group, n=35), or did not perform any training sessions (inactive control', 'Smartphone-Based Approach-Avoidance Intervention', 'smartphone-based approach-avoidance training', 'smartphone-based approach-avoidance intervention']","['chocolate craving and consumption', 'Chocolate Craving and Consumption', 'body fat mass']",[],"[{'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1533153', 'cui_str': 'Fives'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0312922,"Ecological momentary assessment reports evidenced no differences in chocolate craving and consumption between intervention days and rest days as a function of the group.
","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Meule', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Richard', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Radomir', 'Initials': 'R', 'LastName': 'Dinic', 'Affiliation': 'Department of MultiMediaTechnology, Salzburg University of Applied Sciences, Puch, Austria.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blechert', 'Affiliation': 'Department of Psychology, University of Salzburg, Salzburg, Austria.'}]",JMIR mHealth and uHealth,['10.2196/12298']
3280,32106174,Effects of transcutaneous electrical nerve stimulation on physical symptoms in advanced cancer patients receiving palliative care.,"Transcutaneous electrical nerve stimulation (TENS) is primarily used for pain, but might be useful for various other physical symptoms, including nausea, fatigue, dyspnea, and constipation. However, few studies have used TENS for treating the physical symptoms of patients with advanced cancer. In this crossover trial, we assess the effects of TENS on pain and other physical symptoms in 20 in-patients with advanced cancer receiving palliative care. For 5-day phases between wash out periods of 5 days, patients received TENS or non-TENS. TENS was delivered at four points: the center of the back for mainly nausea and dyspnea, on the back at the same dermatomal level as the origin of the pain (100 Hz), and on both ankle joints for constipation (10 Hz). The intensity of pain and the total opioid dose used during phases were recorded. Physical symptoms were evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL). Hematological and biochemical data were recorded before and after the TENS phase. The average pain and total number of opioid rescue doses were significantly reduced by TENS. TENS tended to improve nausea and appetite loss, but not constipation. There were no effects on hematological and biochemical parameters. Use of TENS could safely improve pain, nausea, and appetite loss in patients with advanced cancer. Although it cannot be used as a substitute for opioids and other pharmaceutical treatment, it may be useful to support palliative care.",2020,There were no effects on hematological and biochemical parameters.,"['advanced cancer patients receiving palliative care', 'patients with advanced cancer', '20 in-patients with advanced cancer receiving palliative care']","['Transcutaneous electrical nerve stimulation (TENS', 'TENS or', 'Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL', 'transcutaneous electrical nerve stimulation', 'TENS']","['pain and other physical symptoms', 'Hematological and biochemical data', 'intensity of pain', 'pain, nausea, and appetite loss', 'hematological and biochemical parameters', 'average pain and total number of opioid rescue doses', 'Physical symptoms', 'European Organization for Research and Treatment of Cancer (EORTC', 'physical symptoms', 'nausea and appetite loss']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",,0.0414373,There were no effects on hematological and biochemical parameters.,"[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakano', 'Affiliation': 'Institute of Biomedical Sciences (Health Sciences), Nagasaki University.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ishii', 'Affiliation': 'Palliative Care Team, Nagasaki University Hospital, Nagasaki.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Fukushima', 'Affiliation': 'Department of Musculoskeletal Oncology and Rehabilitation, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Ishii', 'Affiliation': 'Department of Rehabilitation, Michinoo-Miyata Orthopedic Clinic, Nagasaki.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Ueno', 'Affiliation': 'Institute of Biomedical Sciences (Health Sciences), Nagasaki University.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Matsuura', 'Affiliation': 'Institute of Biomedical Sciences (Health Sciences), Nagasaki University.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Hashizume', 'Affiliation': 'Institute of Biomedical Sciences (Health Sciences), Nagasaki University.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Morishita', 'Affiliation': 'Palliative Care Team, Nagasaki University Hospital, Nagasaki.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Graduate School of Health Sciences, Gunma University, Gunma.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kusuba', 'Affiliation': 'Department of Nursing Sciences, International University of Health and Welfare, Fukuoka, Japan.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000386']
3281,31389599,Therapy with ticagrelor for ST-elevated acute coronary syndrome accompanied by diabetes mellitus.,"OBJECTIVE


To investigate the protective effect of ticagrelor on the myocardium of patients with ST-elevated acute coronary syndrome accompanied by diabetes mellitus.
PATIENTS AND METHODS


210 patients with diabetes mellitus receiving emergency percutaneous coronary intervention (PCI) due to ST-elevated acute coronary syndrome from December 2014 to June 2018 in the Hospital were selected and randomly divided into ticagrelor group and clopidogrel group. The myocardial microcirculation perfusion was evaluated via ST-segment elevation resolution (STR) in electrocardiogram (ECG) and myocardial blush grade (MBG). Myocardial necrosis markers, including creatine kinase (CK), CK-MB, and cardiac troponin I (cTnI), were evaluated. Moreover, the cardiac function was assessed using brain natriuretic peptide (BNP) level and left ventricular ejection fraction (LVEF). Finally, patients were followed up for one month on average, and the adverse cardiovascular and bleeding events were recorded.
RESULTS


The results showed that CK, CK-MB, cTnI, and BNP levels in ticagrelor group were lower than those in clopidogrel group, and the differences were statistically significant (p<0.05). Thrombolysis in myocardial infarction (TIMI) flow grading after the operation had no statistically significant difference between the two groups, and the usage rate of tirofiban in ticagrelor group was lower than that in clopidogrel group (p<0.05). Besides, the myocardial microcirculation perfusion level after the operation in ticagrelor group was significantly higher than that in clopidogrel group. The proportions of STR ≥50% in ECG and MBG2 in ticagrelor group were significantly higher than those in clopidogrel group (p<0.01). The incidence rate of mild bleeding in ticagrelor group was higher than that in clopidogrel group (p<0.05).
CONCLUSIONS


The application of ticagrelor in the treatment of ST-elevated acute coronary syndrome accompanied by diabetes mellitus can increase the level of myocardial microcirculation perfusion and improve the left heart function.",2019,"Thrombolysis in myocardial infarction (TIMI) flow grading after the operation had no statistically significant difference between the two groups, and the usage rate of tirofiban in ticagrelor group was lower than that in clopidogrel group (p<0.05).","['ST-elevated acute coronary syndrome accompanied by diabetes mellitus', '210 patients with diabetes mellitus receiving emergency percutaneous coronary intervention (PCI) due to ST-elevated acute coronary syndrome from December 2014 to June 2018 in the Hospital', 'patients with ST-elevated acute coronary syndrome accompanied by diabetes mellitus']","['ticagrelor', 'ticagrelor group and clopidogrel', 'clopidogrel']","['adverse cardiovascular and bleeding events', 'incidence rate of mild bleeding', 'usage rate of tirofiban', 'myocardial microcirculation perfusion', 'myocardial infarction (TIMI) flow grading', 'Myocardial necrosis markers, including creatine kinase (CK), CK-MB, and cardiac troponin', 'CK, CK-MB, cTnI, and BNP levels', 'brain natriuretic peptide (BNP) level and left ventricular ejection fraction (LVEF', 'myocardial microcirculation perfusion level', 'ST-segment elevation resolution (STR) in electrocardiogram (ECG) and myocardial blush grade (MBG']","[{'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532297', 'cui_str': 'Emergency percutaneous coronary intervention'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C3854442', 'cui_str': 'Myocardial necrosis marker'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0523584', 'cui_str': 'Creatine kinase MB measurement'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005874', 'cui_str': 'Blushings'}]",210.0,0.0151215,"Thrombolysis in myocardial infarction (TIMI) flow grading after the operation had no statistically significant difference between the two groups, and the usage rate of tirofiban in ticagrelor group was lower than that in clopidogrel group (p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Special Examination, Binzhou City Center Hospital, Binzhou, China. 285880332@qq.com.'}, {'ForeName': 'L-Y', 'Initials': 'LY', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'X-Z', 'Initials': 'XZ', 'LastName': 'Li', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201908_18662']
3282,31389607,Observation of efficacy of TACE combined with HIFU on patients with middle-advanced liver cancer.,"OBJECTIVE


To study the efficacy of transarterial chemoembolization (TACE) combined with high-intensity focused ultrasound (HIFU) in patients with middle-advanced liver cancer.
PATIENTS AND METHODS


A total of 100 patients with middle-advanced liver cancer treated in our hospital from January 2015 to January 2018 were selected and randomly divided into TACE group (control group, n=50) and TACE combined with HIFU group (experimental group, n=50) according to different therapeutic regimens. The efficacy was observed after the operation, the blood was collected to detect the postoperative liver function indexes aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the postoperative complications were observed. Also, the immune indexes cluster of differentiation 3+ (CD3+), CD4+, and CD8+ were determined. Moreover, the quality of life (QOL) score was compared between the two groups, the 1-, 2-, 3-, and 5-year survival rates were observed after the operation. Also, the changes in the levels of tumor markers α-L-fucosidase (AFU), alpha-fetoprotein (AFP), carbohydrate antigen 19-9 (CA19-9), and carcinoembryonic antigen (CEA) were observed.
RESULTS


In experimental group, the levels of AST, ALT, and blood urea nitrogen (BUN) after the operation were significantly decreased (p<0.05), while the postoperative efficacy was significantly superior to that in control group (p<0.05). The incidence of postoperative complications was significantly reduced (p<0.05), the levels of CD3+, CD4+, CD8+, and natural killer (NK) cells were markedly increased (p<0.05). Also, the QOL score was evidently better than that in control group (p<0.05) and the 1-, 2-, 3-, and 5- year survival rates after the operation were evidently higher than those in control group (p<0.05). After treatment, the levels of AFU, AFP, CA19-9, and CEA were remarkably lower than those before treatment in both groups, while they were remarkably lower in experimental group than those in control group (p<0.05).
CONCLUSIONS


TACE combined with HIFU in the treatment of patients with middle-advanced liver cancer can restore the hepatic metabolism, enhance the immunity, improve the QOL, prolong the survival time of patients, and significantly reduce the tumor markers. Also, it has fewer adverse reactions and definite overall efficacy, which is worthy of popularization and application.",2019,"The incidence of postoperative complications was significantly reduced (p<0.05),","['100 patients with middle-advanced liver cancer treated in our hospital from January 2015 to January 2018', 'patients with middle-advanced liver cancer']","['TACE combined with HIFU', 'transarterial chemoembolization (TACE) combined with high-intensity focused ultrasound (HIFU', 'TACE']","['incidence of postoperative complications', 'postoperative liver function indexes aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the postoperative complications', 'QOL score', 'immune indexes cluster of differentiation 3+ (CD3+), CD4+, and CD8', 'levels of AFU, AFP, CA19-9, and CEA', 'postoperative efficacy', 'levels of CD3+, CD4+, CD8+, and natural killer (NK) cells', '5-year survival rates', 'survival time', 'levels of AST, ALT, and blood urea nitrogen (BUN', 'quality of life (QOL) score', '5- year survival rates', 'levels of tumor markers α-L-fucosidase (AFU), alpha-fetoprotein (AFP), carbohydrate antigen 19-9 (CA19-9), and carcinoembryonic antigen (CEA']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0034380'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0682743', 'cui_str': 'Fucosidase (substance)'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}]",2018.0,0.0157888,"The incidence of postoperative complications was significantly reduced (p<0.05),","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Nursing, First People's Hospital of Jingzhou City, First Affiliated Hospital of Yangtze University, Jingzhou, China. sunye1969@163.com.""}, {'ForeName': 'S-Q', 'Initials': 'SQ', 'LastName': 'Bian', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kou', 'Affiliation': ''}, {'ForeName': 'H-L', 'Initials': 'HL', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'S-S', 'Initials': 'SS', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Z-S', 'Initials': 'ZS', 'LastName': 'Cao', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201908_18653']
3283,32096616,Robot-assisted arm training for treating adult patients with distal radius fracture: a proof-of-concept pilot study.,"BACKGROUND


Fracture of the distal radius is a common wrist injury. As to its management after orthopedic (conservative or surgical) treatment, there is weak evidence for conventional rehabilitation interventions. Despite the increasing interest for robot-assisted arm therapy as to neurological disabilities and its growing diffusion in rehabilitation facilities, no previous study investigated the feasibility of robotic training on arm orthopedic impairment.
AIM


To evaluate the feasibility in terms of efficacy of robot-assisted arm training on upper limb impairment in patients with fracture of the distal radius.
DESIGN


Proof-of-concept, pilot, randomized controlled trial.
SETTING


University hospital.
POPULATION


Twenty adult outpatients with distal radius fracture due to wrist injury.
METHODS


All participants underwent ten, 1-hour (40 minutes of arm training + 20 minutes of conventional occupational therapy) training sessions, five days a week for two consecutive weeks. They were randomly assigned to two groups: patients allocated to the Robotic Arm Training group received arm training by means of a robotic device and patients allocated to the Conventional Arm Training group performed arm training following a conventional rehabilitation program. All patients were evaluated before, immediately after treatment and at four weeks of follow-up. The following outcomes were considered at the affected arm: forearm pronation/supination and wrist extension/flexion passive and active range of motion; maximal pinch and grip strength; the Patient-Rated Wrist and Hand Evaluation.
RESULTS


No difference was found between groups as to the primary (wrist active and passive range of motion) and secondary (pinch and grip strength; Patient-Rated Wrist and Hand Evaluation Score) outcomes at all time points. Within-group comparisons showed similar improvements at all time points as to all outcomes considered in both groups.
CONCLUSIONS


Our preliminary findings support the hypothesis that robot-assisted arm training might be a feasible tool for treating upper limb impairment in adult patients with distal radius fracture treated conservatively or surgically.
CLINICAL REHABILITATION IMPACT


The treatment of arm impairment consequent to distal radius fractures by means of robot-assisted arm training may allow therapists to focus on functional rehabilitation during occupational (individual) therapy and supervise (more than one) patients simultaneously during robotic training sessions.",2020,No difference was found between groups as to the primary (wrist active and passive range of motion) and secondary (pinch and grip strength; Patient-Rated Wrist and Hand Evaluation score) outcomes at all time points.,"['University hospital', 'adult patients with distal radius fracture treated conservatively or surgically', 'Twenty adult outpatients with distal radius fracture due to wrist injury', 'adult patients with distal radius fracture', 'patients with fracture of the distal radius']","['robot-assisted arm training', 'robotic training', 'robot-assisted arm training may allow therapists to focus on functional rehabilitation during occupational (individual) therapy and supervise (more than one) patients simultaneously during robotic training sessions', 'Robot-assisted arm training', 'Robotic Arm Training group received arm training by means of a robotic device and patients allocated to the Conventional Arm Training group performed arm training following a conventional rehabilitation program', 'conventional occupational therapy) training sessions']","['forearm pronation/supination and wrist extension/flexion passive and active range of motion; maximal pinch and grip strength; the Patient-Rated Wrist and Hand Evaluation', 'primary (wrist active and passive range of motion) and secondary (pinch and grip strength; Patient-Rated Wrist and Hand Evaluation score) outcomes']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0043264', 'cui_str': 'Wrist Injuries'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation (regime/therapy)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0033421', 'cui_str': 'Pronation'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0418416', 'cui_str': 'Pinched (event)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.0379017,No difference was found between groups as to the primary (wrist active and passive range of motion) and secondary (pinch and grip strength; Patient-Rated Wrist and Hand Evaluation score) outcomes at all time points.,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Section of Physical and Rehabilitation Medicine, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy - alessandro.picelli@univr.it.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Unit of Neurorehabilitation, Department of Neurosciences, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Modenese', 'Affiliation': 'Unit of Neurorehabilitation, Department of Neurosciences, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Section of Physical and Rehabilitation Medicine, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saggioro', 'Affiliation': 'Unit of Neurorehabilitation, Department of Neurosciences, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Section of Physical and Rehabilitation Medicine, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Corain', 'Affiliation': 'Unit of Hand Surgery, Department of Surgery and Odontology, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Section of Physical and Rehabilitation Medicine, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06112-2']
3284,31549899,Safety and efficacy results of simulated post-exposure prophylaxis with human immune globulin (HRIG; KEDRAB) co-administered with active vaccine in healthy subjects: a comparative phase 2/3 trial.,"We conducted a clinical trial to assess the safety and putative efficacy of an additional human rabies immune globulin (HRIG; KEDRAB) versus an older product (Comparator, HyperRAB S/D® [Grifols]) and determine whether HRIG interferes with development of endogenous antibodies versus Comparator, when each is given with an active rabies vaccine. This was a prospective, double-blind, single-period, non-inferiority study in which subjects were randomized (1:1) to a single dose (20 IU/kg) of HRIG or Comparator on day 0 and rabies vaccine (RabAvert® [GlaxoSmithKline]; 1 mL of ≥2.5 IU/mL) on days 0, 3, 7, 14, and 28. Anti-rabies antibodies were measured by rapid fluorescent focus inhibition test on day 14, and subjects were followed until day 185. Rabies virus neutralizing antibody (RVNA) titers ≥0.5 IU/mL were considered seroconversion putatively indicative of protection. The non-inferiority criterion was the lower limit of the 90% confidence interval (CI) >-10%, for the between-group difference in the proportion of subjects achieving RVNA ≥0.5 IU/mL. On day 14, 98.3% of 59 subjects in the HRIG group and 100% of 59 in the Comparator group had RVNA ≥0.5 IU/mL (difference between proportions - 1.8%; 90% CI, - 8.2, 3.1; non-inferiority criterion met). One subject in the HRIG group did not meet the seroconversion criteria for anti-rabies antibody, and one subject in the Comparator group showed an anamnestic response, with much higher than expected anti-rabies antibody levels at both baseline and on day 14. Thus, HRIG allows for prophylactic anti-rabies antibody titers and is non-inferior to Comparator, when administered with rabies vaccine.",2020,"On day 14, 98.3% of 59 subjects in the HRIG group and 100% of 59 in the Comparator group had RVNA ≥0.5 IU/mL (difference between proportions - 1.8%; 90% CI, - 8.2, 3.1; non-inferiority criterion met).",['healthy subjects'],"['HRIG or Comparator on day 0 and rabies vaccine (RabAvert® [GlaxoSmithKline', 'additional human rabies immune globulin (HRIG; KEDRAB', 'simulated post-exposure prophylaxis with human immune globulin (HRIG; KEDRAB) co-administered with active vaccine']","['safety and putative efficacy', 'Safety and efficacy', 'anamnestic response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034496', 'cui_str': 'Rabies Vaccines'}, {'cui': 'C0722981', 'cui_str': 'RabAvert'}, {'cui': 'C0301503', 'cui_str': 'rabies immune globulin, human'}, {'cui': 'C4535504', 'cui_str': 'Kedrab'}, {'cui': 'C1443861', 'cui_str': 'Post-Exposure Prevention'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021055', 'cui_str': 'Immunological Memory'}]",59.0,0.205227,"On day 14, 98.3% of 59 subjects in the HRIG group and 100% of 59 in the Comparator group had RVNA ≥0.5 IU/mL (difference between proportions - 1.8%; 90% CI, - 8.2, 3.1; non-inferiority criterion met).","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Matson', 'Affiliation': 'Investigator. Prism Research, St. Paul, MN, USA.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Schenker', 'Affiliation': 'Department of Medical Affairs, Kamada Ltd, Beit Kama, MP Negev, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Department of Medical Affairs, Kamada Ltd, Beit Kama, MP Negev, Israel.'}, {'ForeName': 'Vladislava', 'Initials': 'V', 'LastName': 'Zamfirova', 'Affiliation': 'Department of Medical Affairs, Kedrion Biopharma Inc, Fort Lee, NJ, USA.'}, {'ForeName': 'Huy-Binh', 'Initials': 'HB', 'LastName': 'Nguyen', 'Affiliation': 'Department of Medical Affairs, Kedrion Biopharma Inc, Fort Lee, NJ, USA.'}, {'ForeName': 'Garrett E', 'Initials': 'GE', 'LastName': 'Bergman', 'Affiliation': 'Department of Medical Affairs, Kedrion Biopharma Inc, Fort Lee, NJ, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1656967']
3285,31888504,"Continuous intravenous infusion of remifentanil improves the experience of parturient undergoing repeated cesarean section under epidural anesthesia, a prospective, randomized study.","BACKGROUND


Unsatisfactory analgesia would occur frequently during repeated cesarean section under epidural anesthesia. The aim of this study is to observe the effects of intravenous remifentanil on maternal comfort, maternal and neonatal safety during repeated cesarean section under epidural anesthesia.
METHODS


A total of 80 parturients undergoing repeated cesarean section were involved in the study. The patients were randomly divided into the intravenous remifentanil- assisted epidural group (group R) and epidural group (group E), respectively (n = 40). In group R, the remifentanil was continuously intravenously infused as an adjuvant to epidural anesthesia. In group E, 0.75% ropivacaine epidural or intravenous ketamine was administered as needed. Parturient baseline characteristics, vital signs, VAS scores, and comfort scores during surgery were recorded. Adverse effects were also recorded.
RESULTS


A total of 80 patients were enrolled in the current study and the final analyses included 39 patients in group R and 38 patients in group E. No differences in patients' baseline characteristics were found between the two groups (p > 0.05). Compared with group E, the comfort score was significantly higher in group R (9.1 ± 1.0 vs. 7.5 ± 1.3, p <  0.001), whereas the maximum VAS score was significantly lower in group R (1.8 ± 1.2 vs. 4.1 ± 1.0, p <  0.001). Maternal and neonatal adverse effects did not differ between the two groups during surgery (p > 0.05).
CONCLUSIONS


Continuous intravenous infusion of low-dose remifentanil can significantly improve the experience of parturients undergoing repeated cesarean section under epidural anesthesia, without noticeable maternal or neonatal adverse effects.
TRIAL REGISTRATION


This study was pre-registered at http://www.chictr.org.cn/index.aspx (ChiCTR1800018423) on 17/09/2018.",2019,"Maternal and neonatal adverse effects did not differ between the two groups during surgery (p > 0.05).
","['parturients undergoing repeated cesarean section under epidural anesthesia', '80 parturients undergoing repeated cesarean section were involved in the study', 'parturient undergoing repeated cesarean section under epidural anesthesia', '80 patients']","['remifentanil', 'intravenous remifentanil- assisted epidural group', 'ropivacaine epidural or intravenous ketamine']","['maximum VAS score', 'Maternal and neonatal adverse effects', 'comfort score', 'Adverse effects', 'Parturient baseline characteristics, vital signs, VAS scores, and comfort scores', 'maternal comfort, maternal and neonatal safety']","[{'cui': 'C0206101', 'cui_str': 'Repeat Cesarean Section'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0549411', 'cui_str': 'Neonatal adverse effect'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0518766'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.102388,"Maternal and neonatal adverse effects did not differ between the two groups during surgery (p > 0.05).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Province, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Province, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Province, China.'}, {'ForeName': 'Feng-Jiang', 'Initials': 'FJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Province, China.'}, {'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang Province, China. zryanmin@zju.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-019-0900-x']
3286,30741439,PEP uP (Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol) in Surgical Patients-A Multicenter Pilot Randomized Controlled Trial.,"BACKGROUND


The Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol (PEP uP) has been shown to be feasible, safe, and effective in delivering significantly more energy/protein, though it has not been well studied in surgical/trauma patients. We hypothesized that PEP uP will effectively increase energy/protein delivery to critically ill surgical/trauma patients.
METHODS


This multicenter, prospective, randomized pilot study included adult patients admitted to surgical service who were expected to require mechanical ventilation for >24 hours and intensive care unit (ICU) care for >72 hours. Subjects were randomized to PEP uP or standard care. The PEP uP protocol includes initiation at goal rate, semi-elemental formula, prophylactic prokinetic agents, 24-hour volume-based goals, and modular protein supplementation. The primary outcome was nutrition adequacy over the first 12 ICU days.
RESULTS


Thirty-six subjects were enrolled. Slow recruitment resulted in early trial termination by the sponsor. There were no baseline differences between groups. PEP uP patients received more protein (106.8 ± 37.0 vs 78.5 ± 30.3 g/d, P = 0.02). Energy delivery was not significantly different (1400.0 ± 409.5 vs 1237.9 ± 459.1 kcal, P = 0.25). Vomiting was more common in the PEP uP patients (32% vs 12%, P = 0.03). PEP uP protocol violations included 2 patients (15.4%) not receiving pro-motility medications, 3 (23.1%) not receiving volume-based feeds as ordered, and 4 (30.8%) not receiving supplemental protein.
CONCLUSIONS


In surgical/trauma patients, PEPuP seemed to improve protein delivery but was difficult to implement successfully and may increase vomiting rates.",2020,"Vomiting was more common in the PEP uP patients (32% vs 12%, P = 0.03).","['Surgical Patients', 'Thirty-six subjects were enrolled', 'adult patients admitted to surgical service who were expected to require mechanical ventilation for >24\xa0hours and intensive care unit (ICU) care for >72\xa0hours']","['PEP', 'PEPuP', 'PEP uP or standard care', 'PEP uP (Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol']","['vomiting rates', 'nutrition adequacy over the first 12 ICU days', 'Energy delivery', 'Vomiting']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0587668', 'cui_str': 'Surgical service (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1522196', 'cui_str': 'Enteral route (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",36.0,0.104643,"Vomiting was more common in the PEP uP patients (32% vs 12%, P = 0.03).","[{'ForeName': 'D Dante', 'Initials': 'DD', 'LastName': 'Yeh', 'Affiliation': 'Ryder Trauma Center/University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Luis Alfonso', 'Initials': 'LA', 'LastName': 'Ortiz', 'Affiliation': ""Clinical Evaluation Research Unit, Kingston General Hospital, Department of Critical Care, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Jae Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Massachusetts General Hospital, Harvard University, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Jamaica Hospital Medical Center, New York City, New York, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'Jamaica Hospital Medical Center, New York City, New York, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Jamaica Hospital Medical Center, New York City, New York, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Chetelat', 'Affiliation': 'Jamaica Hospital Medical Center, New York City, New York, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Collier', 'Affiliation': 'Carilion Clinic, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Carilion Clinic, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Clinical Evaluation Research Unit, Kingston General Hospital, Department of Critical Care, Queen's University, Kingston, Ontario, Canada.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1521']
3287,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3288,31628035,Repeated GnRH agonist doses for luteal support: a proof of concept.,"RESEARCH QUESTION


What are the safety and feasibility of repeated subcutaneous doses of gonadotrophin-releasing hormone (GnRH) agonist for luteal support in IVF cycles triggered by a GnRH agonist?
DESIGN


In this prospective trial, patients exhibiting oestradiol concentrations of over 2500 pg/ml after use of a GnRH agonist for triggering ovulation were initially randomized to GnRH agonist luteal support (0.1 mg subcutaneously every other day, starting on day 3 after embryo transfer) or to a control group supported by 80 µg of recombinant human chorionic gonadotrophin (HCG) on day 3 after embryo transfer. All patients underwent a day 5 blastocyst transfer. Randomization to the HCG luteal support was stopped owing to two cases of ovarian hyperstimulation syndrome (OHSS) and the study was continued solely with GnRH agonist luteal support.
RESULTS


The study included 39 women in the repeated GnRH agonist luteal support group and seven in the HCG micro dose group. There were no cases of OHSS among patients supported by a GnRH agonist, and no other adverse events were recorded. There were no cases of bleeding before the pregnancy test, and hence no cases of an insufficient luteal phase. A clinical pregnancy rate of 43.6% was achieved with GnRH agonist luteal support. Hormone dynamics during the stimulation cycle reflected rising LH and progesterone concentrations after the introduction of GnRH agonist support.
CONCLUSIONS


Repeated doses of GnRH agonist every other day as a method of luteal support provided safe and effective luteal support for women who underwent GnRH agonist triggering in a GnRH antagonist IVF cycle.",2019,"There were no cases of OHSS among patients supported by a GnRH agonist, and no other adverse events were recorded.","['39 women in the repeated GnRH agonist luteal support group and seven in the HCG micro dose group', 'patients exhibiting oestradiol concentrations of over 2500\xa0pg/ml after use of a GnRH agonist for triggering ovulation']","['gonadotrophin-releasing hormone (GnRH) agonist', 'recombinant human chorionic gonadotrophin (HCG', 'GnRH agonist luteal support']","['clinical pregnancy rate', 'rising LH and progesterone concentrations', 'bleeding', 'adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1527152', 'cui_str': 'Product containing recombinant human chorionic gonadotrophin (medicinal product)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",39.0,0.0599673,"There were no cases of OHSS among patients supported by a GnRH agonist, and no other adverse events were recorded.","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Wiser', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel. Electronic address: amir.wiser@gmail.com.'}, {'ForeName': 'Anat Hershko', 'Initials': 'AH', 'LastName': 'Klement', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Shavit', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Berkovitz', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Roni Rahav', 'Initials': 'RR', 'LastName': 'Koren', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Gonen', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Amichay', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Shulman', 'Affiliation': 'Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel; The Sackler school of medicine, Meir medical centre, Tel Aviv University.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.07.031']
3289,32105616,Evaluation of Success of Transport Disc Distraction Osteogenesis and Costochondral Graft for Ramus Condyle Unit Reconstruction in Pediatric Temporomandibular Joint Ankylosis.,"PURPOSE


The costochondral graft (CCG) is considered the reference standard for pediatric temporomandibular joint reconstruction. It has the disadvantages of unpredictable growth, donor site morbidity, and the need for intermaxillary fixation. It has been reported that transport disk distraction osteogenesis (TDDO) can result in the formation of a neocondyle and disc. We performed a randomized trial to measure and compare clinically relevant outcomes of ramus-condyle unit (RCU) reconstruction using CCG and TDDO for pediatric temporomandibular joint ankylosis (TMJA).
MATERIALS AND METHODS


In the present randomized controlled trial (block randomization with a variable block size), pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16 years who had presented to our unit from December 2015 to June 2017 were enrolled. Instead of temporalis myofascial flap interposition, a buccal fat pad was used to fill the gap created by osteoarthrectomy. The primary outcome parameter was mouth opening. A mouth opening of at least 25 mm at the median follow-up point was considered success. The secondary outcome parameters were occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation. Data were analyzed using the independent t test and rank sum test.
RESULTS


A total of 24 patients were enrolled in the CCG and TDDO groups (n = 12 in each group). Trauma (40.9%) was the most common etiology with a slight male preponderance (59.09%). The mean age was 10.32 ± 2.85 years. The average distraction achieved in the TDDO group was 10.42 mm. The median follow-up duration was 31.5 months (range, 24 to 39 months). The mean preoperative maximal incisal opening had improved from 8.5 ± 4.1 and 9.5 ± 7.1 mm in the CCG and TDDO groups preoperatively to 35.7 ± 2.7 and 34.4 ± 8.9 mm, respectively, at the median follow-up point (P < .005). RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed statistically non-significant differences. No reankylosis or open bite was found. The 3-hour delayed gadolinium-enhanced magnetic resonance imaging scan showed successful neo-disc formation.
CONCLUSIONS


Similar success can be achieved in RCU reconstruction using either CCG or TDDO for pediatric TMJA. Both techniques have some advantages and disadvantages. RCU reconstruction using CCG or TDDO results in formation of a neocondyle, maintenance of occlusion, and correction of facial asymmetry.",2020,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","['24 patients were enrolled in the CCG and TDDO groups (n\xa0=\xa012 in each group', 'The mean age was 10.32\xa0±\xa02.85\xa0years', 'Pediatric Temporomandibular Joint Ankylosis', 'pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16\xa0years who had presented to our unit from December 2015 to June 2017 were enrolled']","['transport disk distraction osteogenesis', 'Transport Disc Distraction Osteogenesis and Costochondral Graft', 'ramus-condyle unit (RCU) reconstruction using CCG and TDDO', 'temporalis myofascial flap interposition', 'gadolinium-enhanced magnetic resonance imaging scan']","['mouth opening', 'average distraction', 'mean preoperative maximal incisal opening', 'occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0524975', 'cui_str': 'Osteogenesis, Distraction'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0039487', 'cui_str': 'Temporal Muscle'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1306710', 'cui_str': 'Facial asymmetry (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",24.0,0.0728373,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","[{'ForeName': 'Kamalpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Research Scientist, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ajoyroy@hotmail.com.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashu Seith', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravinder M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.029']
3290,32003938,"A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension.","This multicenter, randomized, double-blind, parallel-group phase III clinical trial aimed to investigate the efficacy and safety of a rosuvastatin + amlodipine combination compared with that of rosuvastatin or amlodipine monotherapy in hypertensive patients with dyslipidemia. A total of 106 patients of 15 institutions in Korea were randomly assigned to 1 of 3 treatment groups: rosuvastatin 20 mg + amlodipine 10 mg, amlodipine 10 mg, or rosuvastatin 20 mg. After 8 weeks of treatment, the mean ± SD of change in mean sitting systolic blood pressure (msSBP) was -22.82 ± 12.99 mm Hg in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. The percentage of patients whose msSBP decreased ≥20 mm Hg or msDBP decreased ≥10 mm Hg was also highest in this group (74.29%). The mean ± SD percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline after 8 weeks was -52.53% ± 11.21% in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. More patients in the rosuvastatin + amlodipine group achieved their target LDL-C goal at 8 weeks, compared with the other treatment groups (97.14%). No serious adverse events or adverse drug reactions were observed in all groups. In hypertensive patients with dyslipidemia, combination treatment with rosuvastatin 20 mg + amlodipine 10 mg effectively reduced blood pressure and LDL-C levels while maintaining safety.",2020,No serious adverse events or adverse drug reactions were observed in all groups.,"['patients with dyslipidemia and hypertension', '106 patients of 15 institutions in Korea', 'hypertensive patients with dyslipidemia']","['20\xa0mg\xa0+\xa0amlodipine', 'amlodipine monotherapy', 'rosuvastatin 20\xa0mg\xa0+\xa0amlodipine', 'rosuvastatin\xa0', 'amlodipine', 'amlodipine/rosuvastatin', 'rosuvastatin', 'rosuvastatin\xa0+\xa0amlodipine', 'amlodipine 10\xa0mg, or rosuvastatin']","['blood pressure and LDL-C levels', 'efficacy and safety', 'target LDL-C goal', 'mean\xa0±\xa0SD of change in mean sitting systolic blood pressure (msSBP', 'mean\xa0±\xa0SD percentage change in low-density lipoprotein cholesterol (LDL-C) level', 'msSBP decreased ≥20\xa0mm Hg or msDBP decreased ≥10', 'serious adverse events or adverse drug reactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1124794', 'cui_str': 'Amlodipine 10 MG'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1319893', 'cui_str': 'Sitting systolic blood pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",106.0,0.0654033,No serious adverse events or adverse drug reactions were observed in all groups.,"[{'ForeName': 'Woohyeun', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Kiyuk', 'Initials': 'K', 'LastName': 'Chang', 'Affiliation': ""Division of Cardiology, Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Eun Joo', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': ""Division of Cardiology, St. Paul's Hospital, Seoul, Korea.""}, {'ForeName': 'Jeong-Cheon', 'Initials': 'JC', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Korea University Ansan Hospital, Ansan, Korea.'}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': 'Division of Cardiology, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Kyoung-Im', 'Initials': 'KI', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Maryknoll Medical Center, Busan, Korea.'}, {'ForeName': 'Yong-Jin', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Duk-Hyun', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Valvular Heart Disease Center, Asan Medical Center Heart Institute, Seoul, Korea.'}, {'ForeName': 'Seok-Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Seoul Medical Center, Seoul, Korea.'}, {'ForeName': 'Sang-Hak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Seoul, Korea.'}, {'ForeName': 'Ung', 'Initials': 'U', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Yeungnam University Medical Center, Daegu, Korea.'}, {'ForeName': 'Shin-Jae', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Ulsan University Hospital, Ulsan, Korea.'}, {'ForeName': 'Young Keun', 'Initials': 'YK', 'LastName': 'Ahn', 'Affiliation': 'Heart Center of Chonnam, National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Chang Hoon', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Veterans Health Service Medical Center, Seoul, Korea.'}, {'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Mikyung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Yuhan Research Institute, Yuhan Corporation, Yongin, Korea.'}, {'ForeName': 'Chang Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13774']
3291,31530074,Combination treatment in metastatic castration-resistant prostate cancer: can we safely boost efficacy by adding radium-223?,"ERA 223, a phase III, international, multicenter, double-blind study published in  Lancet Oncology , was the first randomized controlled trial to investigate combined radium-223 (Ra-223) and abiraterone acetate plus prednisone or prednisolone (AAP) therapy. The data from ERA 223 demonstrated no increase in efficacy for this combination over AAP alone, and instead identified a significant safety concern due to the higher risk of fracture in the co-treatment group. The surprising results of this trial likely stem from the compounding osteoporotic effects of the different treatments, particularly the addition of prednisone, and supplementing therapy regimens with osteoprotective agents may aid in mitigating this safety risk.",2020,"The data from ERA 223 demonstrated no increase in efficacy for this combination over AAP alone, and instead identified a significant safety concern due to the higher risk of fracture in the co-treatment group.",['metastatic castration-resistant prostate cancer'],"['prednisone', 'combined radium-223 (Ra-223) and abiraterone acetate plus prednisone or prednisolone (AAP) therapy']",['efficacy'],"[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],223.0,0.159218,"The data from ERA 223 demonstrated no increase in efficacy for this combination over AAP alone, and instead identified a significant safety concern due to the higher risk of fracture in the co-treatment group.","[{'ForeName': 'Martina A', 'Initials': 'MA', 'LastName': 'Knechel', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Schmidt', 'Affiliation': 'Clinical Pharmacology Program, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}]",Cancer biology & therapy,['10.1080/15384047.2019.1665395']
3292,32035692,A phase II multicenter randomized controlled trial to compare standard chemoradiation with or without recombinant human endostatin injection (Endostar) therapy for the treatment of locally advanced nasopharyngeal carcinoma: Long-term outcomes update.,"PURPOSE


This study aimed to observe the feasibility and safety of addition of recombinant human endostatin injection to standard chemoradiation for the locally advanced nasopharyngeal carcinoma. Current follow-up results updated long-term efficacy and late toxicity of the trial.
METHODS


Between July 2012 and December 2013, we enrolled 114 patients that are older than 18 years with stage Ⅲ-Ⅳb nasopharyngeal carcinoma from 3 centers in Guizhou, China. Fifty six patients who received standard chemoradiation combined with recombinant human endostatin injection (Endostar) were included in the study group. Another 58 patients were randomly assigned to the control group without using Endostar. Patients in both groups received the same 2 cycles of induction chemotherapy (Docetaxel 75 mg/m 2 , cisplatin 80 mg/m 2 ), followed by 2 cycles of concurrent intensity-modulated radiation therapy with cisplatin (DDP; 80 mg/m 2  on days 1 and 22). The patients in the experimental group received 2 cycles Endostar (7.5 mg/m 2  d8-d21 during induction chemotherapy and d1-d14 during concurrent chemoradiation).
RESULTS


There were no significant differences of toxicities between the 2 groups. Chemotherapy and radiotherapy compliance between the 2 groups was similar. No hemorrhage and coagulation dysfunction in the experimental group were observed. There was a median follow-up of 67.1 months. Comparing the short-time effect of 3 months to the completion of chemoradiotherapy, there was a little higher objective response rate in the experimental group. Compared with the control group, the experimental group improved in the complete remission rate of cervical lymph node metastasis (91.1% vs 72.4%, χ 2  = 3.897, P = 0.048). However, there was no significant difference in the curative effect of nasopharyngeal lesions between the 2 groups. (78.6% vs 74.1%, χ 2  = 0.310, P = 0.578). The 5-year overall survival, progression-free of survival, metastasis-free survival, and locoregional failure-free survival rates in the 2 groups were 69.6%, 67.8%, 78.75, and 83.0%, respectively, for the experimental group, these rates were 73.2%, 80.1%, 81.7%, and 91.0%, respectively, and for the control group, no significant difference was found (P > 0.05).
CONCLUSIONS


Patients show good tolerance and compliance with a manageable toxicity profile to the regimen of chemoradiation plus Endostar. There was a little higher objective response rate in the study group. A phase 3 randomized study is needed to substantiate our findings.",2020,"The 5-year overall survival, progression-free of survival, metastasis-free survival, and locoregional failure-free survival rates in the 2 groups were 69.6%, 67.8%, 78.75, and 83.0%, respectively, for the experimental group, these rates were 73.2%, 80.1%, 81.7%, and 91.0%, respectively, and for the control group, no significant difference was found (P > 0.05).
","['locally advanced nasopharyngeal carcinoma', 'Another 58 patients', 'Fifty six patients who received', '114 patients that are older than 18 years with stage Ⅲ-Ⅳb nasopharyngeal carcinoma from 3 centers in Guizhou, China', 'Between July 2012 and December 2013']","['standard chemoradiation combined with recombinant human endostatin injection (Endostar', 'control group without using Endostar', 'chemoradiation plus Endostar', 'induction chemotherapy (Docetaxel 75 mg/m 2 , cisplatin 80 mg/m 2 ), followed by 2 cycles of concurrent intensity-modulated radiation therapy with cisplatin (DDP', 'recombinant human endostatin injection to standard chemoradiation', 'standard chemoradiation with or without recombinant human endostatin injection (Endostar) therapy', '2 cycles Endostar']","['complete remission rate of cervical lymph node metastasis', 'hemorrhage and coagulation dysfunction', 'objective response rate', 'Chemotherapy and radiotherapy compliance', 'toxicities', '5-year overall survival, progression-free of survival, metastasis-free survival, and locoregional failure-free survival rates', 'curative effect of nasopharyngeal lesions']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0534628', 'cui_str': 'Endostatins'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node structure (body structure)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",114.0,0.0560223,"The 5-year overall survival, progression-free of survival, metastasis-free survival, and locoregional failure-free survival rates in the 2 groups were 69.6%, 67.8%, 78.75, and 83.0%, respectively, for the experimental group, these rates were 73.2%, 80.1%, 81.7%, and 91.0%, respectively, and for the control group, no significant difference was found (P > 0.05).
","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Soochow University, Suzhou, Jiangsu, China; Department of Head and Neck Oncology, Affiliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Radiotherapy Oncology, The Second Affiliated Hospital of Soochow University, Institute of Radiotherapy and Oncology, Soochow University, Suzhou Key Laboratory for Radiation Oncology, Suzhou, Jiangsu, China. Electronic address: dryettian@126.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': 'Department of Head and Neck Oncology, Affiliated Hospital of Guizhou Medical University, Guiyang, China. Electronic address: jinf8865@yeah.net.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Head and Neck Oncology, Affiliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Department of Head and Neck Oncology, Affiliated Hospital of Guizhou Medical University, Guiyang, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': ""Department of Head and Neck Oncology, Guizhou Provincial People's Hospital, Guiyang, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Zunyi Medical College, Zunyi, China.'}]",Current problems in cancer,['10.1016/j.currproblcancer.2019.06.007']
3293,30996379,[Clinical evaluation of the effect of reducing tooth sensitivity caused by in office bleaching using dentifrices].,"OBJECTIVE


To evaluate tooth sensitivity and the efficacy of in-office bleaching when using different desensitizing dentifrices.
METHODS


In total, 150 eligible individuals were recruited and randomized by computer-generated block randomization into three groups: potassium nitrate group (n=50), stannous fluoride group (n=50), and placebo group (n=50). Participants were asked to use a desensitizing dentifrice and toothbrush 15 days prior to and after the in-office bleaching. Each patient received a one-session in-office bleaching with 35% hydrogen peroxide whitening gel. The in-office bleaching included three 15 min operations, totally 45 min. Tooth sensitivity was evaluated by 100 mm visual analog scale (VAS) scores immediately 0 d and 1 d, 2 d, 7 d, 14 d, and 30 d after in-office bleaching. In total, 48 (96%), 45 (90%), and 46 (92%) individuals in the potassium nitrate, stannous fluoride, and placebo groups, respectively, completed the follow-up observations.
RESULTS


Data were analyzed using analysis of covariance (ANOVA). For tooth sensitivity produced by in-office bleaching, the mean VAS values of the three groups were analyzed. At 0 d immediately after surgery, the mean VAS of the potassium nitrate group was 39.22±15.08, which was lower than that of the stannous fluoride group (47.18±12.59) and the placebo group (52.53±14.05), and the difference was statistically significant (P<0.05). The results of the stannous fluoride group and the placebo group were similar, and the difference was not statistically significant (P>0.05). On 1 day postoperatively, the mean VAS of the potassium nitrate group was 38.27±16.52, which was lower than that of the stannous fluoride group (44.69±14.92) and the placebo group (44.45±13.54), P<0.05. The results of the stannous fluoride group and the placebo group were similar, and the difference was not statistically significant (P>0.05). The mean values of VAS were similar 2 d, 7 d, 14 d and 30 d after operation, and the difference was not statistically significant (P>0.05).
CONCLUSION


Compared with the stannous fluoride group and the placebo group, the use of potassium nitrate desensitizing toothpaste 15 days before surgery can effectively alleviate the tooth sensitivity during and after in-office bleaching.",2019,"The results of the stannous fluoride group and the placebo group were similar, and the difference was not statistically significant (P>0.05).",['150 eligible individuals'],"['stannous fluoride', 'placebo', 'office bleaching using dentifrices', 'desensitizing dentifrice and toothbrush 15 days prior to and after the in-office bleaching', 'one-session in-office bleaching with 35% hydrogen peroxide whitening gel', 'potassium nitrate desensitizing toothpaste', 'potassium nitrate group']","['mean values of VAS', 'Tooth sensitivity', 'tooth sensitivity', 'mean VAS', 'mean VAS values', 'visual analog scale (VAS) scores']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0303749', 'cui_str': 'Bleach (substance)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",150.0,0.126953,"The results of the stannous fluoride group and the placebo group were similar, and the difference was not statistically significant (P>0.05).","[{'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Luo', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Department of Prosthodontics, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
3294,31888511,Comparison of videolaryngoscope-guided versus standard digital insertion techniques of the ProSeal™ laryngeal mask airway: a prospective randomized study.,"BACKGROUND


This study were designed to investigate the usefulness of the videolaryngoscope-guided insertion technique compared with the standard digital technique for the insertion success rate and insertion conditions of the Proseal™ laryngeal mask airway (PLMA).
METHODS


Prospective, one hundred and nineteen patients (ASA I-II, aged 18-65 yr) were randomly divided for PLMA insertion using the videolaryngoscope-guided technique or the standard digital technique. The PLMA was inserted according to the manufacturer's instructions in the standard digital technique group. The videolaryngoscope-guided technique was performed a C-MAC® videolaryngoscope with D-Blade, under gentle videolaryngoscope guidance, the epiglottis was lifted, and the PLMA was advanced until the tip of the distal cuff reached the oesophagus inlet. The number of insertion attempts, insertion time, oropharyngeal leak pressure, leak volume, fiberoptic bronchoscopic view, peak inspiratory pressure, ease of gastric tube placement, hemodynamic changes, visible blood on PLMA and postoperative airway morbidity were recorded.
RESULTS


The first-attempt success rate (the primary outcome) was higher in the videolaryngoscope-guided technique than in the standard digital technique (p = 0.029). The effect size values with 95% confidence interval were 0.19 (0.01-0.36) for the first and second attempts, 0.09 (- 0.08-0.27) for the first and third attempts, and not computed for the second and third attempts by the groups, respectively.
CONCLUSION


Videolaryngoscope-guided insertion technique can be a help in case of difficult positioning of a PLMA and can improve the PLMA performance in some conditions. We suggest that the videolaryngoscope-guided technique may be a useful technique if the digital technique fails.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03852589 date of registration: February 22th 2019.",2019,The first-attempt success rate (the primary outcome) was higher in the videolaryngoscope-guided technique than in the standard digital technique (p = 0.029).,"['Prospective, one hundred and nineteen patients (ASA I-II, aged 18-65\u2009yr', 'ProSeal™ laryngeal mask airway']","['standard digital technique', 'videolaryngoscope-guided versus standard digital insertion techniques', 'videolaryngoscope-guided insertion technique', 'PLMA insertion using the videolaryngoscope-guided technique or the standard digital technique']","['number of insertion attempts, insertion time, oropharyngeal leak pressure, leak volume, fiberoptic bronchoscopic view, peak inspiratory pressure, ease of gastric tube placement, hemodynamic changes, visible blood on PLMA and postoperative airway morbidity', 'PLMA performance']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope (physical object)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1301933', 'cui_str': 'Airway morbidity'}]",119.0,0.0566369,The first-attempt success rate (the primary outcome) was higher in the videolaryngoscope-guided technique than in the standard digital technique (p = 0.029).,"[{'ForeName': 'Ulku', 'Initials': 'U', 'LastName': 'Ozgul', 'Affiliation': 'School of Medicine, Department of Anesthesiology and Reanimation, Inonu University, Malatya, Turkey. ulku.ozgul@inonu.edu.tr.'}, {'ForeName': 'Feray Akgul', 'Initials': 'FA', 'LastName': 'Erdil', 'Affiliation': 'School of Medicine, Department of Anesthesiology and Reanimation, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Mehmet Ali', 'Initials': 'MA', 'LastName': 'Erdogan', 'Affiliation': 'School of Medicine, Department of Anesthesiology and Reanimation, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Zekine', 'Initials': 'Z', 'LastName': 'Begec', 'Affiliation': 'School of Medicine, Department of Anesthesiology and Reanimation, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Colak', 'Affiliation': 'School of Medicine, Department of Biostatistics, and Medical Informatics, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Aytac', 'Initials': 'A', 'LastName': 'Yucel', 'Affiliation': 'School of Medicine, Department of Anesthesiology and Reanimation, Inonu University, Malatya, Turkey.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Durmus', 'Affiliation': 'School of Medicine, Department of Anesthesiology and Reanimation, Inonu University, Malatya, Turkey.'}]",BMC anesthesiology,['10.1186/s12871-019-0915-3']
3295,31863573,Rate and Risk Factors of Superior Facet Joint Violation during Cortical Bone Trajectory Screw Placement: A Comparison of Robot-Assisted Approach with a Conventional Technique.,"OBJECTIVE


To compare the incidence and risk factors of superior facet joint violation (FJV) during cortical bone trajectory screw placement in robot-assisted approach versus conventional technique.
METHODS


A retrospective study, including 69 patients having cortical bone trajectory (CBT) screw instrumentation for symptomatic degenerated diseases or trauma, was conducted between June 2015 to January 2019. All patients underwent CBT surgery performed by the same team of experienced surgeons. Patients were randomly divided into two groups: a conventional group (CG, 46 cases) and a robot group (RG, 23 cases). The surgical robotic system was used for screw instrumentation in the robot group and the traditional screw instrumentation with fluoroscopic guidance was used in the conventional group. Cortical screws followed a medio-to-lateral path in the transverse plane and a caudal-to-cephalad path in the sagittal plane. Preoperative and postoperative computed tomography (CT) scans were obtained to determine the degree and incidence of FJV. The violation status of facet joint was evaluated according to the modified classification: grade 0, no violation; grade 1, screw shaft, screw head or rod within 1 mm of or abutting the facet joint, but did not enter the articular facet joint; grade 2, screw shaft, screw head or rod clearly in the facet joint. The following factors that may contribute to the occurrence of FJV were analyzed: age, sex, body mass index (BMI), proximal fusion level, fusion length, the side of screw, preoperative vertebral slip, superior facet angle, and degenerative scoliosis. The chi-squared test and Student's t-test were used for analysis of the variables for significance (P < 0.05).
RESULTS


FJV occurred in 41.3% of patients in CG and 17.3% of patients in RG. A chi-squared analysis revealed a significantly lower rate of FJV for RG compared with CG (P = 0.04). In the CG, 17 of the 109 cephalad screws were grade 1 (15.6%), and five were grade 2 (4.6%). In the RG, three of the 46 cephalad screws were grade 1 (6.5%), and three were grade 2 (6.5%). There was a statistically significant difference in the incidence of FJV between the left and right screw with fluoroscopy-assisted CBT screw instrumentation (P < 0.05). A significant correlation between scoliosis with the FJV was found in CG (P < 0.05) and in RG (P < 0.05). With regard to superior facet angle, a measurement ≥45° was a significant risk factor of FJV in CG (P < 0.05) and in RG (P < 0.05).
CONCLUSIONS


A robot-assisted approach could reduce the incidence of FJV compared with the conventional approach in CBT technique.",2020,A significant correlation between scoliosis with the FJV was found in CG (P < 0.05) and in RG (P < 0.05).,"['69 patients having cortical bone trajectory (CBT) screw instrumentation for symptomatic degenerated diseases or trauma, was conducted between June 2015 to January 2019']","['superior facet joint violation (FJV', 'CBT surgery', 'conventional group (CG', 'cortical bone trajectory screw placement', 'Robot-Assisted Approach with a Conventional Technique', 'Cortical Bone Trajectory Screw Placement']","['rate of FJV for RG', 'FJV', 'incidence of FJV', 'risk factor of FJV in CG', 'Preoperative and postoperative computed tomography (CT) scans', 'Rate and Risk Factors of Superior Facet Joint Violation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224521', 'cui_str': 'Facet Joint'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone (body structure)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224521', 'cui_str': 'Facet Joint'}]",,0.0227139,A significant correlation between scoliosis with the FJV was found in CG (P < 0.05) and in RG (P < 0.05).,"[{'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Le', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Qi-Long', 'Initials': 'QL', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Yun-Feng', 'Initials': 'YF', 'LastName': 'Xu', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Zhao', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Department of Spine Surgery, Beijing Jishuitan Hospital, Beijing, China.'}]",Orthopaedic surgery,['10.1111/os.12598']
3296,32092190,"Randomized, Controlled Trial of Exercise on Objective and Subjective Sleep in Parkinson's Disease.","BACKGROUND


Sleep dysfunction is common and disabling in persons with Parkinson's Disease (PD). Exercise improves motor symptoms and subjective sleep quality in PD, but there are no published studies evaluating the impact of exercise on objective sleep outcomes. The goal of this study was to to determine if high-intensity exercise rehabilitation combining resistance training and body-weight interval training, compared with a sleep hygiene control improved objective sleep outcomes in PD.
METHODS


Persons with PD (Hoehn & Yahr stages 2-3; aged ≥45 years, not in a regular exercise program) were randomized to exercise (supervised 3 times a week for 16 weeks; n = 27) or a sleep hygiene, no-exercise control (in-person discussion and monthly phone calls; n = 28). Participants underwent polysomnography at baseline and post-intervention. Change in sleep efficiency was the primary outcome, measured from baseline to post-intervention. Intervention effects were evaluated with general linear models with measurement of group × time interaction. As secondary outcomes, we evaluated changes in other aspects of sleep architecture and compared the effects of acute and chronic training on objective sleep outcomes.
RESULTS


The exercise group showed significant improvement in sleep efficiency compared with the sleep hygiene group (group × time interaction: F = 16.0, P < 0.001, d = 1.08). Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep. Chronic but not acute exercise improved sleep efficiency compared with baseline.
CONCLUSIONS


High-intensity exercise rehabilitation improves objective sleep outcomes in PD. Exercise is an effective nonpharmacological intervention to improve this disabling nonmotor symptom in PD. © 2020 International Parkinson and Movement Disorder Society.",2020,"Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep.","['Persons with PD (Hoehn & Yahr stages 2-3; aged ≥45\u2009years, not in a regular exercise program', ""Parkinson's Disease"", 'PD', ""persons with Parkinson's Disease (PD""]","['Exercise', 'High-intensity exercise rehabilitation', 'sleep hygiene, no-exercise control', 'high-intensity exercise rehabilitation combining resistance training and body-weight interval training']","['total sleep time, wake after sleep onset, and slow-wave sleep', 'Objective and Subjective Sleep', 'sleep efficiency', 'motor symptoms and subjective sleep quality', 'objective sleep outcomes']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.070578,"Other parameters of sleep architecture also improved in exercise compared with sleep hygiene, including total sleep time, wake after sleep onset, and slow-wave sleep.","[{'ForeName': 'Amy W', 'Initials': 'AW', 'LastName': 'Amara', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Kimberly H', 'Initials': 'KH', 'LastName': 'Wood', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Joop', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Raima A', 'Initials': 'RA', 'LastName': 'Memon', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pilkington', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reams', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Arthur L', 'Initials': 'AL', 'LastName': 'Weltman', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Hurt', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'UAB Center for Exercise Medicine. Birmingham, Alabama, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28009']
3297,32085906,Association of the Intensive Lifestyle Intervention With Total Knee Replacement in the Look AHEAD (Action for Health in Diabetes) Clinical Trial.,"BACKGROUND


Evidence has established obesity as a risk factor for total knee replacement (TKR) due to osteoarthritis. Obesity is a risk factor for TKR. Randomized trials such as Look AHEAD (Action for Health in Diabetes) have shown long-term successful weight loss with an intensive lifestyle intervention (ILI). It is unknown, however, if intentional weight loss can reduce the risk of TKR.
METHODS


Look AHEAD randomized persons aged 45-76 with type 2 diabetes who had overweight or obesity to either an ILI to achieve/maintain 7% weight loss or to standard diabetes support and education (DSE). Reported knee pain was assessed using the Visual Analog Scale and Western Ontario McMaster University Osteoarthritis Index questionnaire in 5125 participants without previous TKR. Cox proportional hazard regression was used to model differences in risk of TKR in relation to randomization group assignment (ILI vs DSE) along with baseline body mass index category and baseline knee pain as potential confounders from baseline through Look AHEAD-Extension.
RESULTS


Baseline mean ± SD Western Ontario McMaster University Osteoarthritis Index knee pain scores did not differ by treatment assignment (ILI: 3.6 ± 2.9, DSE: 3.9 ± 3.0, P = .08); as expected due to randomization. During follow up, the 631 (12%) participants who reported having a TKR were more likely to have been heavier (P < .001) and older (P < .001) at enrollment, but risk of TKR did not differ by treatment group assignment (hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.91-1.25, P = .43). Heterogeneity of treatment effect was observed according to baseline knee pain (interaction P = .02). In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96). However, in persons with knee pain at baseline, there was no statistically significant association of treatment assignment with respect to subsequent TKR incidence (HR 1.11, 95% CI 0.92-1.33).
CONCLUSION


Findings suggest that intensive lifestyle change including physical activity, dietary restriction and behavioral changes to achieve weight loss for prevention of TKR may be most effective in preventing TKR prior to the development of knee pain.",2020,"In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96).","['persons aged 45-76 with type 2 diabetes who had overweight or obesity to either an ILI to achieve/maintain 7% weight loss or to standard diabetes support and education (DSE', '5125 participants without previous TKR', 'Diabetes', 'Health in Diabetes']",['Intensive Lifestyle Intervention With Total Knee Replacement'],"['Baseline mean ± SD Western Ontario McMaster University Osteoarthritis Index knee pain scores', 'risk of TKR in ILI', 'knee pain', 'Visual Analog Scale and Western Ontario', 'subsequent TKR incidence']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",5125.0,0.0668287,"In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96).","[{'ForeName': 'Phyllis A', 'Initials': 'PA', 'LastName': 'Richey', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN; Department of Physical Therapy, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Bahnson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Singhal', 'Affiliation': 'Department of Physical Therapy, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Fridtjof', 'Initials': 'F', 'LastName': 'Thomas', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Mihalko', 'Affiliation': 'Department of Biomedical Engineering, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of arthroplasty,['10.1016/j.arth.2020.01.057']
3298,32085946,"""Healthy""/""Unhealthy"" Food Brands Influence Health, Calorie, and Price Ratings of Food.","OBJECTIVE


To assess the effect of healthy or unhealthy food brands on consumer ratings of a food's perceived healthfulness, caloric content, and estimated price.
METHODS


Using a crossover design, 35 adults aged 18-25 years scored a variety of healthy and unhealthy foods paired with ""healthy"" or ""unhealthy"" brands or with no brand present, on their healthfulness, caloric content, and estimated price. For each outcome measure, ANOVA was used to evaluate the effect of brand condition on healthy and unhealthy foods.
RESULTS


Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001). Pairing a healthy food with an ""unhealthy brand"" led to decreased ratings of healthfulness (P < .001), increased estimates of caloric content (P < .001), and decreased price (P < .001).
CONCLUSIONS AND IMPLICATIONS


These findings extend previous research showing that brands may influence perceptions of food products. Future studies are needed to understand the implications of pairing healthy foods with ""unhealthy brands"" on actual food intake.",2020,"Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001).","['35 adults aged 18-25 years scored a variety of healthy and unhealthy foods paired with ""healthy"" or ""unhealthy"" brands or with no brand present, on their healthfulness, caloric content, and estimated price']",['healthy or unhealthy food brands'],"['ratings of healthfulness', 'caloric content', 'increased price']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]",35.0,0.0443924,"Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001).","[{'ForeName': 'Travis D', 'Initials': 'TD', 'LastName': 'Masterson', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH. Electronic address: Travis.D.Masterson@dartmouth.edu.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Florissi', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Clark', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, NH.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gilbert-Diamond', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.01.008']
3299,32071465,[Clinical outcomes of ultrasonic subgingival debridement combined with manual root planing in severe periodontitis].,"OBJECTIVE


To compare the clinical effects of ultrasonic subgingival debridement and ultrasonic subgingival debridement combined with manual root planing on severe periodontitis and then to investigate the necessity and significance of manual root planing.
METHODS


Twenty-three patients with severe periodontitis participated in this split-mouth randomized-controlled clinical trial. Baseline examination and randomization were performed after supragingival scaling: each of the upper and lower jaws had a quadrant as the test group treated with ultrasonic subgingival debridement combined with manual root planing, whereas the other two quadrants were the control group treated with ultrasonic subgingival debridement. Treatment of each patient was at intervals of one week and completed in two visits. Clinical indicators concerning probing depth (PD), clinical attachment loss (CAL) and bleeding index (BI) were recorded at baseline and 1 month, 3 months, 6 months after treatment.
RESULTS


There was no significant difference of periodontal indicators between the test group and the control group at baseline. Both the test group and control group resulted in significant improvement of PD, CAL and BI. One and three months after treatment, reduction of PD in the test group was higher than that in the control group [1 month: (2.13±1.31) mm vs. (1.79±1.33) mm, P<0.01; 3 months: (2.46±1.33) mm vs. (2.17±1.38) mm, P<0.01] and reduction of CAL in the test group was higher than that in the control group [1 month: (1.89±2.03) mm vs. (1.65±1.93) mm, P<0.01; 3 months: (2.03±2.05) mm vs. (1.83±1.97) mm, P<0.05]. Six months after treatment, PD in the test group and the control group decreased by (2.52±1.40) mm and (2.35±1.37) mm respectively, and the improvement in the test group was significantly better than that in the control group (P<0.01). CAL in the test group and the control group decreased by (1.89±2.14) mm and (1.77±2.00) mm respectively, and there was no statistical difference between the groups. There was no significant difference in the changes of BI between the two groups 1, 3 and 6 months after treatment.
CONCLUSION


Ultrasonic subgingival debridement combined with manual root planing has more reduction in PD and CAL compared with ultrasonic subgingival debridement. Therefore, it is still necessary to use manual instruments for root planing following ultrasonic subgingival debridement.",2020,"Six months after treatment, PD in the test group and the control group decreased by (2.52±1.40) mm and (2.35±1.37) mm respectively, and the improvement in the test group was significantly better than that in the control group (P<0.01).","['Twenty-three patients with severe periodontitis participated in this split-mouth randomized-controlled clinical trial', 'severe periodontitis']","['ultrasonic subgingival debridement combined with manual root planing', 'ultrasonic subgingival debridement and ultrasonic subgingival debridement combined with manual root planing', 'ultrasonic subgingival debridement']","['changes of BI', 'probing depth (PD), clinical attachment loss (CAL) and bleeding index (BI', 'CAL', 'PD and CAL', 'PD, CAL and BI', 'reduction of PD', 'reduction of CAL', 'periodontal indicators']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0206035', 'cui_str': 'Controlled Clinical Trials, Randomized'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",23.0,0.0524403,"Six months after treatment, PD in the test group and the control group decreased by (2.52±1.40) mm and (2.35±1.37) mm respectively, and the improvement in the test group was significantly better than that in the control group (P<0.01).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'X E', 'Initials': 'XE', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Zhan', 'Affiliation': 'Department of General Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology, Beijing 100034, China.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Miao', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Zhang', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Yue', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Hu', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Hou', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences,[]
3300,32080858,Regenerative potential of cultured gingival fibroblasts in treatment of periodontal intrabony defects (randomized clinical and biochemical trial).,"BACKGROUND


Defective cellular elements constitute an important challenge to achieve predictable periodontal regeneration. In an attempt to improve the cellularity of periodontal defects, gingival fibroblasts were implanted without their associated extracellular elements in periodontal defects to expose them to periodontal tissue mediators. In order to investigate the regenerative potential of gingival fibroblasts translocated into periodontal defects, the present study was designed to clinically and biochemically investigate the use of gingival fibroblasts (GF) and their associated mesenchymal stem cells (GMSC) in the treatment of intrabony periodontal defects.
METHODS


A total of 20 subjects were randomly divided into two groups (n = 20). Group I: ten patients were included with ten intrabony periodontal defects that received β-calcium triphosphate (β-TCP) followed by collagen membrane defect coverage, while group II: (10 patients) ten periodontal defects received cultured gingival fibroblasts (GF) on the β-TCP scaffold and covered by a collagen membrane. The clinical evaluation was carried out at the beginning and at 6 months. Gingival crevicular fluid (GCF) samples were collected directly from the test sites for the quantitative measurement of PDGF-BB and BMP-2 using the ELISA kit at 1, 7, 14, and 21 days after surgery.
RESULTS


Group II reported a significantly greater reduction in vertical pocket depth (VPD) and CAL gain compared with group I after 6 months. Radiographic bone gain was statistically higher in group II compared with group I. A significantly higher concentration of PDGF-BB was observed in group II on days 1, 3, and 7 compared with group I.
CONCLUSIONS


Translocation of gingival fibroblasts from gingival tissue to periodontal defects could be a promising option that increases cellular elements with regeneration potential. The concept of total isolation of gingival fibroblasts using occlusive membranes must be re-evaluated.",2020,"Radiographic bone gain was statistically higher in group II compared with group I. A significantly higher concentration of PDGF-BB was observed in group II on days 1, 3, and 7 compared with group I.
CONCLUSIONS


Translocation of gingival fibroblasts from gingival tissue to periodontal defects could be a promising option that increases cellular elements with regeneration potential.","['Group I: ten patients were included with ten intrabony periodontal defects that received', '20 subjects']","['β-calcium triphosphate (β-TCP) followed by collagen membrane defect coverage, while group II: (10 patients) ten periodontal defects received cultured gingival fibroblasts (GF', 'gingival fibroblasts (GF) and their associated mesenchymal stem cells (GMSC', 'cultured gingival fibroblasts']","['PDGF-BB', 'vertical pocket depth (VPD) and CAL gain', 'Radiographic bone gain', 'Gingival crevicular fluid (GCF) samples']","[{'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1960460', 'cui_str': 'Intrabony periodontal defect'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0146894', 'cui_str': 'triphosphate'}, {'cui': 'C0044091', 'cui_str': 'tenocyclidine-TCP'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0016030', 'cui_str': 'Fibroblasts'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",20.0,0.0208254,"Radiographic bone gain was statistically higher in group II compared with group I. A significantly higher concentration of PDGF-BB was observed in group II on days 1, 3, and 7 compared with group I.
CONCLUSIONS


Translocation of gingival fibroblasts from gingival tissue to periodontal defects could be a promising option that increases cellular elements with regeneration potential.","[{'ForeName': 'Mahetab', 'Initials': 'M', 'LastName': 'Abdal-Wahab', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Abdel Ghaffar', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ola M', 'Initials': 'OM', 'LastName': 'Ezzatt', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Abdel Aziz', 'Initials': 'AAA', 'LastName': 'Hassan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Mervat Mohamed S', 'Initials': 'MMS', 'LastName': 'El Ansary', 'Affiliation': 'Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Y', 'Initials': 'AY', 'LastName': 'Gamal', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Nahda University, Cairo, Egypt.'}]",Journal of periodontal research,['10.1111/jre.12728']
3301,31279794,Effects of glucocorticoid and noradrenergic activity on spatial learning and spatial memory in healthy young adults.,"BACKGROUND


Acute stress leads to a rapid release of noradrenaline and glucocorticoids, which in turn influence cognitive functions such as spatial learning and memory. However, few studies have investigated noradrenergic and glucocorticoid effects on spatial learning and memory in humans. Therefore, we examined the separate and combined effects of noradrenergic and glucocorticoid stimulation on spatial learning and memory.
METHODS


One hundred and four healthy men (mean age = 24.1 years ±SD 3.5) underwent the virtual Morris Water Maze (vMWM) task to test spatial learning and spatial memory retrieval after receiving either 10 mg hydrocortisone or 10 mg yohimbine (an alpha 2-adrenergic receptor antagonist that increases noradrenergic activity), 10 mg hydrocortisone and 10 mg yohimbine combined, or placebo. The vMWM task took place 90 min after yohimbine was administered and 75 min after hydrocortisone was administered. Placebo was given at the same times. Salivary cortisol and alpha amylase levels were measured to check pharmacological stimulation.
RESULTS


Hydrocortisone and yohimbine increased salivary cortisol and alpha amylase levels. Participants' task performance improved over time, suggesting successful spatial learning. However, separate and combined noradrenergic and glucocorticoid stimulation had no effect on spatial learning and spatial memory retrieval compared with placebo.
CONCLUSIONS


In healthy young men, hydrocortisone and/or yohimbine did not alter spatial learning or spatial memory retrieval. Importantly, pharmacological stimulation took place prior to learning. Further studies should examine the effects of glucocorticoid and noradrenergic stimulation during encoding, consolidation, and retrieval.",2019,"However, separate and combined noradrenergic and glucocorticoid stimulation had no effect on spatial learning and spatial memory retrieval compared with placebo.
","['healthy young men', 'healthy young adults', 'One hundred and four healthy men (mean age\u2009=\u200924.1 years ±SD 3.5) underwent the']","['Placebo', 'noradrenergic and glucocorticoid stimulation', 'hydrocortisone and 10\u2009mg yohimbine combined, or placebo', 'Hydrocortisone and yohimbine', 'yohimbine', 'hydrocortisone', 'glucocorticoid and noradrenergic activity', 'hydrocortisone and/or yohimbine', 'virtual Morris Water Maze (vMWM) task']","['spatial learning and spatial memory retrieval', 'spatial learning or spatial memory retrieval', 'salivary cortisol and alpha amylase levels', 'spatial learning and spatial memory', 'spatial learning and memory', 'task performance improved over time, suggesting successful spatial learning', 'Salivary cortisol and alpha amylase levels']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0582587', 'cui_str': 'Spatial Learning'}, {'cui': 'C0814087', 'cui_str': 'Spatial Memory'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3853624', 'cui_str': 'alpha-amylase'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",104.0,0.0901301,"However, separate and combined noradrenergic and glucocorticoid stimulation had no effect on spatial learning and spatial memory retrieval compared with placebo.
","[{'ForeName': 'Woo Ri', 'Initials': 'WR', 'LastName': 'Chae', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: woo-ri.chae@charite.de.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Weise', 'Affiliation': 'Department of Psychology, University of Potsdam, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Nowacki', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Piber', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany; Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, United States.'}, {'ForeName': 'Sven C', 'Initials': 'SC', 'LastName': 'Mueller', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",Behavioural brain research,['10.1016/j.bbr.2019.112072']
3302,32073619,Iron Absorption from Bouillon Fortified with Iron-Enriched Aspergillus oryzae Is Higher Than That Fortified with Ferric Pyrophosphate in Young Women.,"BACKGROUND


Bouillon cubes are a potential vehicle for iron fortification. They are currently fortified with ferric pyrophosphate (FePP), which is known to be poorly absorbed. The objective of this study was to assess the iron absorption of Aspergillus oryzae grown in FePP (ASP-p) and compare it with FePP and ferrous sulfate (FeSO4)-fortified bouillon cubes.
METHODS


In 2 single-blinded, crossover studies, healthy women with serum ferritin concentrations <40 μg/L were randomly assigned to consume a rice-vegetable meal with iron-fortified chicken bouillon. Subjects in study I (n = 17, 18-26 y) consumed iron from both iron sources as 57FePP and 58ASP-p (intrinsically labeled with 58FePP) with a meal containing 4.2 mg of total iron provided for 3 d. Study II (n = 18, 18-29 y) was similar except that subjects consumed 57FeSO4 and 58ASP-p. Whole-blood stable isotope enrichment after 14 d was used to measure fractional iron absorption. Hemoglobin, hematocrit, serum ferritin, hepcidin, and serum C-reactive protein were analyzed at baseline and at 14 d. A t test was used to compare the mean differences in fractional absorptions within each study and baseline characteristics between studies.
RESULTS


Geometric mean (95% CI) fractional iron absorption of FePP [0.94% (0.63%, 1.40%)] was lower than ASP-p [2.20% (1.47%, 3.30%)] (P < 0.0001) in study I. In study II, ASP-p fractional absorption [2.98% (2.03%, 4.38%)] was lower than that of FeSO4 [9.88% (6.70%, 14.59%)] (P < 0.0001). Both ferritin (r = -0.41, P = 0.014) and hepcidin (r = -0.42, P = 0.01) concentrations were inversely correlated with ASP-p iron absorption. Fractional absorption of ASP-p was also positively correlated with FePP (r = 0.92, P < 0.0001) and FeSO4 (r = 0.52, P < 0.02) absorption.
CONCLUSIONS


ASP-p-fortified bouillon provided 2.3-fold higher absorbable iron than the currently used FePP. Bouillon fortified with ASP-p may contribute sufficient bioavailable iron to meet the daily iron requirements in young women only if consumed with other iron-fortified staple foods. This trial was registered at clinicaltrials.gov as NCT03586245.",2020,"Fractional absorption of ASP-p was also positively correlated with FePP (r = 0.92, P < 0.0001) and FeSO4 (r = 0.52, P < 0.02) absorption.
","['Subjects in study I (n\xa0', 'young women', 'Young Women', 'healthy women with serum ferritin concentrations <40 μg/L']","['rice-vegetable meal with iron-fortified chicken bouillon', 'ferric pyrophosphate (FePP', 'Fortified with Ferric Pyrophosphate', 'FePP and ferrous sulfate (FeSO4)-fortified bouillon cubes']","['FeSO4', 'hepcidin', 'Hemoglobin, hematocrit, serum ferritin, hepcidin, and serum C-reactive protein', 'fractional iron absorption of FePP', 'Geometric mean', 'ASP-p fractional absorption', 'Fractional absorption of ASP-p']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus domesticus'}, {'cui': 'C0117541', 'cui_str': 'ferric pyrophosphate'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}]","[{'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0206298', 'cui_str': 'European Viper'}]",,0.176089,"Fractional absorption of ASP-p was also positively correlated with FePP (r = 0.92, P < 0.0001) and FeSO4 (r = 0.52, P < 0.02) absorption.
","[{'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Bries', 'Affiliation': 'Department of Food Sciences and Human Nutrition, Iowa State University, Ames, IA, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Hurrell', 'Affiliation': 'ETH Zürich, Institute of Food, Nutrition, and Health, Zurich, Switzerland.'}, {'ForeName': 'Manju B', 'Initials': 'MB', 'LastName': 'Reddy', 'Affiliation': 'Department of Food Sciences and Human Nutrition, Iowa State University, Ames, IA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa035']
3303,31829300,Computerised cognitive-behavioural therapy for depression in adolescents: 12-month outcomes of a UK randomised controlled trial pilot study.,"BACKGROUND


Computerised cognitive-behavioural therapy (CCBT) in the care pathway has the potential to improve access to psychological therapies and reduce waiting lists within Child and Adolescent Mental Health Services, however, more randomised controlled trials (RCTs) are needed to assess this.
AIMS


This single-centre RCT pilot study compared a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression at referral to evaluate the clinical and cost-effectiveness of CCBT (trial registration: ISRCTN31219579).
METHOD


The trial ran within community and clinical settings. Adolescents (aged 12-18) presenting to their primary mental health worker service for low mood/depression support were assessed for eligibility at their initial appointment, 139 met inclusion criteria (a 33-item Mood and Feelings Questionnaire score of ≥20) and were randomised to Stressbusters (n = 70) or self-help websites (n = 69) using remote computerised single allocation. Participants completed mood, quality of life (QoL) and resource-use measures at intervention completion, and 4 and 12 months post-intervention. Changes in self-reported measures and completion rates were assessed by group.
RESULTS


There was no significant difference between CCBT and the website group at 12 months. Both showed improvements on all measures. QoL measures in the intervention group showed earlier improvement compared with the website group. Costs were lower in the intervention group but the difference was not statistically significant. The cost-effectiveness analysis found just over a 65% chance of Stressbusters being cost-effective compared with websites. The 4-month follow-up results from the initial feasibility study are reported separately.
CONCLUSIONS


CCBT and self-help websites may both have a place in the care pathway for adolescents with depression.",2019,Costs were lower in the intervention group but the difference was not statistically significant.,"['Adolescents (aged 12-18) presenting to their primary mental health worker service for low mood/depression support were assessed for eligibility at their initial appointment, 139 met inclusion criteria (a 33-item Mood and Feelings Questionnaire score of ≥20) and were randomised to Stressbusters (n = 70) or self-help websites (n = 69) using remote computerised single allocation', 'adolescents with depression', 'adolescents']","['CCBT program (Stressbusters) with an attention control (self-help websites', 'Computerised cognitive-behavioural therapy (CCBT', 'Computerised cognitive-behavioural therapy']","['Costs', 'completion rates', 'QoL measures', 'mood, quality of life (QoL) and resource-use measures']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.109102,Costs were lower in the intervention group but the difference was not statistically significant.,"[{'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Chair in Child Mental Health, Hull York Medical School, University of York & Leeds and York Partnership NHS Foundation Trust, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Tindall', 'Affiliation': 'Research Fellow, Leeds and York Partnership NHS Foundation Trust, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hargate', 'Affiliation': 'Research Manager, Leeds and York Partnership NHS Foundation Trust, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Professor in Medical Statistics, Hull York Medical School, University of York, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Trépel', 'Affiliation': 'Health Economist, Department of Health Sciences, University of York, UK.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Health Economist, Department of Health Sciences, University of York, UK.'}]",BJPsych open,['10.1192/bjo.2019.91']
3304,32077050,Influence of a Planning Intervention on Physical Activity Behavior: the Moderating Role of Intentions and Executive Functions in a Randomized Controlled Trial.,"BACKGROUND


Planning and executive functions (EFs; inhibition, updating, shifting) are self-regulatory variables that help people to become and stay physically active. The aim of this study was to examine how and for whom a planning intervention affects physical activity (PA) behavior in the short term. Therefore, the mediating role of planning and the moderating role of intentions and EFs for the planning-behavior link were examined.
METHOD


In a randomized control trial with two treatment groups (planning group vs. control group) and two points of measurement (t1 and t2, 1 week apart), n = 200 students participated in both measurements. At t1, participants filled in standardized questionnaires assessing PA behavior, intention, and planning. Computer-based tests assessed the following EFs: inhibition, updating, and shifting. At t2, planning and PA behavior were measured again. Moderated mediation analyses were conducted.
RESULTS


A significant increase in PA between t1 and t2 was found for the planning group compared with the control group. Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior. Forming plans was particularly beneficial for participants with high intentions and lower updating performance.
CONCLUSION


Planning enhances PA behavior, particularly when PA intention is high. Poor performance in updating can be compensated by planning since encouraging people to generate plans might facilitate automatic enactment of the behavior.",2020,"Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior.",['participants with high intentions and lower updating performance'],"['Planning Intervention', 'planning intervention']","['physical activity (PA) behavior', 'PA', 'Physical Activity Behavior']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",200.0,0.0249912,"Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior.","[{'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Pfeffer', 'Affiliation': 'Medical School Hamburg, Faculty of Human Science, University of Applied Sciences and Medical University, Am Kaiserkai 1, 20457, Hamburg, Germany. ines.pfeffer@medicalschool-hamburg.de.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Strobach', 'Affiliation': 'Medical School Hamburg, Faculty of Human Science, University of Applied Sciences and Medical University, Am Kaiserkai 1, 20457, Hamburg, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09864-x']
3305,31860534,One Week of L-Citrulline Supplementation Improves Performance in Trained Cyclists.,"Stanelle, ST, McLaughlin, KL, and Crouse, SF. One week of L-citrulline supplementation improves performance in trained cyclists. J Strength Cond Res 34(3): 647-652, 2020-L-citrulline (CIT) is a nonessential amino acid that is touted as an ergogenic aid for athletic performance because of its purported ability to stimulate nitric oxide production. Although previous research has demonstrated that CIT supplementation over a period of days improves physiological factors such as V[Combining Dot Above]O2 kinetics, no studies to date have explored whether there is a direct benefit to endurance performance. This study used a randomized, double-blind, crossover design to test whether chronic supplementation with pure CIT improves cycling performance over a maltodextrin placebo (PLAC). Nine trained male cyclists (24 ± 3 years; 181 ± 7 cm; 76 ± 13 kg; 4.18 ± 0.51 L·min V[Combining Dot Above]O2max) completed two 7-day supplementation periods (6 g·d of CIT or PLAC) separated by a 7-day washout. Subjects consumed the final 6-g dose 2 hours before the cycling performance evaluation, which consisted of a 40-km time trial (TT) followed by a supramaximal sprint repeat task (SRT). Paired t-tests and repeated-measures analysis of variance (α = 0.05) were used to analyze TT and SRT data, respectively. CIT supplementation produced an improvement in TT time of 5.2% that trended toward significance (p = 0.08). Furthermore, CIT promoted a significant increase in average heart rate, average rating of perceived exertion, and average power throughout the TT (p < 0.05). However, supplementation with CIT did not prevent fatigue during the SRT. Overall, this study is the first to demonstrate that CIT supplementation may provide a modest improvement to endurance cycling performance in trained athletes.",2020,"Furthermore, CIT promoted a significant increase in average heart rate, average rating of perceived exertion, and average power throughout the TT (p < 0.05).","['Trained Cyclists', 'trained cyclists', 'trained athletes', 'Nine trained male cyclists (24 ± 3 years; 181 ± 7 cm; 76 ± 13 kg; 4.18 ± 0.51 L·min V[Combining']","['L-citrulline supplementation', 'J Strength Cond Res XX(X', 'CIT supplementation', 'L-Citrulline Supplementation', '2019-L-citrulline (CIT', 'CIT', 'maltodextrin placebo (PLAC', 'chronic supplementation with pure CIT', 'supramaximal sprint repeat task (SRT']","['average heart rate, average rating of perceived exertion, and average power throughout the TT', 'TT time', 'endurance cycling performance', 'fatigue', 'Stanelle, ST, McLaughlin, KL, and Crouse, SF', 'cycling performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048838', 'cui_str': 'PLAC'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.382955,"Furthermore, CIT promoted a significant increase in average heart rate, average rating of perceived exertion, and average power throughout the TT (p < 0.05).","[{'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': 'Stanelle', 'Affiliation': 'Department of Kinesiology, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Kelsey L', 'Initials': 'KL', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Kinesiology, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Crouse', 'Affiliation': 'Department of Kinesiology, Texas A&M University, College Station, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003418']
3306,30946602,Effects of mental imagery training combined electromyogram-triggered neuromuscular electrical stimulation on upper limb function and activities of daily living in patients with chronic stroke: a randomized controlled trial.,"Purpose:  Previous studies have suggested that electromyogram-triggered neuromuscular electrical stimulation is beneficial in enhancing the upper limb function of patients with stroke. However, mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation investigation has received a little attention. This study investigated effects of mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation on upper limb function and activities of daily living of patients with chronic stroke. Method:  Sixty-eight participants were randomly allocated to mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation group or the electromyogram-triggered neuromuscular electrical stimulation group. Both the groups performed each intervention for 30 min a day, 5 days a week, for 6 weeks. The Action Research Arm Test, Fugl-Meyer Assessment, and Korean version of Modified Barthel Index were used for outcome measures. Results:  After the intervention, both the groups showed significant improvements in all outcome measures. However, there were no significant differences in outcome measures between both the groups. Conclusions:  These results indicated that both mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation and electromyogram-triggered neuromuscular electrical stimulation are beneficial to improve the upper limb function and activities of daily living of patients with chronic stroke.Implications for RehabilitationMental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation might be helpful in improving upper limb function of patients with chronic strokeImprovement of upper limb function induced by mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation might increase independence in activities of daily living of patients with chronic stroke.",2020,Implications for Rehabilitation Mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation might be helpful in improving upper limb function of patients with chronic stroke Improvement of upper limb function induced by mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation might increase independence in activities of daily living of patients with chronic stroke.,"['patients with stroke', 'patients with chronic stroke', 'Sixty-eight participants']","['Rehabilitation Mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation', 'electromyogram-triggered neuromuscular electrical stimulation', 'mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation group or the electromyogram-triggered neuromuscular electrical stimulation group', 'mental imagery training combined electromyogram-triggered neuromuscular electrical stimulation', 'mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation and electromyogram-triggered neuromuscular electrical stimulation', 'mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation investigation', 'mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation']",['upper limb function and activities of daily living'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",68.0,0.0304719,Implications for Rehabilitation Mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation might be helpful in improving upper limb function of patients with chronic stroke Improvement of upper limb function induced by mental imagery training combined with electromyogram-triggered neuromuscular electrical stimulation might increase independence in activities of daily living of patients with chronic stroke.,"[{'ForeName': 'Jin-Hyuck', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Bio and Brain Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Republic of Korea.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1577502']
3307,32076866,Effect of different concentrations of commercially available mouthwashes on wound healing following periodontal surgery: a randomized controlled clinical trial.,"OBJECTIVES


The purpose of this study was to evaluate the effect of chlorhexidine and essential oils containing mouth rinses on oral wound healing after periodontal flap surgery.
MATERIALS AND METHODS


Eighty subjects participated in the study and were randomly assigned to use water, 0.12% chlorhexidine (CHX), essential oils (EO), 5% CHX, and 10% EO. Subjects were examined at 1, 2, and 3 weeks postoperatively. Plaque index (PI) and the modified gingival index (GI) were recorded, while wound epithelialization was measured to evaluate the healing process. Numerical data were analyzed with parametric test for multiple comparisons (ANOVA) with Bonferroni correction. Categorical data were analyzed using Chi-square test/fisher exact test.
RESULTS


All groups demonstrated a gradual GI reduction from first to third visit. Patients in the CHX group presented statistically significant lower PI scores than patients in the water group at the all-time points of the study. Wound epithelialization analysis demonstrated that 100% of the sites in the CHX group were healing by secondary intention at visit 1. This finding was statistically significant.
CONCLUSION


Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
CLINICAL RELEVANCE


The use of chlorhexidine and EO containing mouthwashes does not appear to delay wound healing. Diluting these commercial mouthwashes may present an approach that could possibly reduce the adverse effects (such as tooth staining) associated with their use, while maintaining their antibacterial properties.",2020,"Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
","['periodontal surgery', 'Eighty subjects participated in the study and were randomly assigned to use water, 0.12']","['chlorhexidine and essential oils containing mouth rinses', 'CHX', 'chlorhexidine (CHX), essential oils (EO), 5% CHX, and 10% EO', 'chlorhexidine and EO containing mouthwashes']","['PI scores', 'adverse effects', 'Wound epithelialization analysis', 'wound epithelialization', 'delay wound healing', 'Plaque index (PI) and the modified gingival index (GI', 'gradual GI reduction', 'oral wound healing', 'wound healing']","[{'cui': 'C0398950', 'cui_str': 'Periodontal operation (procedure)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4517426', 'cui_str': '0.12 (qualifier value)'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3266038', 'cui_str': 'Wound Epithelialization'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",80.0,0.0616574,"Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
","[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Katsaros', 'Affiliation': 'Department of Periodontics, University of Iowa College of Dentistry and Dental Clinics, 801 Newton Rd., S447, Iowa City, IA, 52241, USA. theodoros-katsaros@uiowa.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mayer', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}, {'ForeName': 'Archontia', 'Initials': 'A', 'LastName': 'Palaiologou', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Romero-Bustillos', 'Affiliation': 'Department of Periodontics, University of Iowa College of Dentistry and Dental Clinics, 801 Newton Rd., S447, Iowa City, IA, 52241, USA.'}, {'ForeName': 'Gerald H', 'Initials': 'GH', 'LastName': 'Evans', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Lallier', 'Affiliation': 'Department of Cell Biology and Anatomy, Louisiana State University Health Sciences Center, New Orleans, LA, 70119, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Maney', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}]",Clinical oral investigations,['10.1007/s00784-020-03232-5']
3308,31375814,"A comparative assessment of orthodontic treatment outcomes using the quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques in adolescents: a single-centre, single-blind randomized controlled trial.","INTRODUCTION


The aim of this two-arm parallel trial was to evaluate enamel demineralization in fixed orthodontic treatment using an indirect bonding technique in comparison to a direct bonding technique by the quantitative light-induced fluorescence (QLF) method.
DESIGN, SETTINGS AND PARTICIPANTS


Fifty-six patients who needed fixed orthodontic treatment were randomly separated into either the direct bonding group or the indirect bonding group. The presence and extent of lesions on the buccal surfaces of all teeth, except the molar teeth, were assessed. The percentage of fluorescence loss (ΔF and ΔFmax), the degree of demineralization (ΔQ) and lesion area (WS area) were determined using the system's software. The data were analysed with the Wilcoxon signed-rank and Mann-Whitney U-tests (P < 0.05).
INTERVENTIONS


Treatment with a direct bonding or an indirect bonding technique.
RESULTS


This study was completed with 25 patients in the indirect bonding group (12 females, 13 males; mean age: 15.42 ± 1.71 years) and 26 patients in the direct bonding group (12 females, 14 males; mean age: 14.73 ± 1.65 years). In the indirect bonding technique, a few teeth (especially mandibular left canine: 50.45 ± 93.48; 95% confidence interval: -12.35 and 113.26) were found to develop significant white spot lesion (WSL) formation (P < 0.05). However, the number of teeth with demineralization was higher in the direct bonding group (P < 0.05).
CONCLUSION


The bonding procedures used in the indirect bonding technique contribute to reducing the degree of WSL formation. Further, the use of flowable composite adhesives in this bonding process is more effective at reducing the appearance of WSLs than in cases where conventional composite adhesives are used.
LIMITATIONS


The limitation of our trial may be the small sample size and the short follow-up time for the patients.
HARMS


No harms were detected during the study.
PROTOCOL


The protocol was not published before trial commencement.
REGISTRATION


This trial was registered post hoc at 'Clinical Trials' (http://www.clinicaltrials.gov), registration number (ID): NCT03738839.",2020,"However, the number of teeth with demineralization was higher in the direct bonding group (P < 0.05).
","['Fifty-six patients who needed fixed orthodontic treatment', 'adolescents', '25 patients in the indirect bonding group (12 females, 13 males; mean age: 15.42 ± 1.71 years) and 26 patients in the direct bonding group (12 females, 14 males; mean age: 14.73 ± 1.65 years']","['direct bonding or an indirect bonding technique', 'direct bonding group or the indirect bonding group', 'quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques']","['number of teeth with demineralization', 'percentage of fluorescence loss (ΔF and ΔFmax), the degree of demineralization (ΔQ) and lesion area (WS area', 'white spot lesion (WSL) formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",56.0,0.0575289,"However, the number of teeth with demineralization was higher in the direct bonding group (P < 0.05).
","[{'ForeName': 'Aykan Onur', 'Initials': 'AO', 'LastName': 'Atilla', 'Affiliation': 'Osmanli Dental Center, Republic of Turkey Ministry of Health, Ankara.'}, {'ForeName': 'Taner', 'Initials': 'T', 'LastName': 'Ozturk', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Erciyes University, Kayseri.'}, {'ForeName': 'Mustafa Murat', 'Initials': 'MM', 'LastName': 'Eruz', 'Affiliation': 'Tesakademya Dental Clinic (Private Practice), Nevsehir, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yagci', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Erciyes University, Kayseri.'}]",European journal of orthodontics,['10.1093/ejo/cjz058']
3309,31335776,"A 3-month, Multicenter, Randomized, Open-label Study to Evaluate the Impact on Wound Healing of the Early (vs Delayed) Introduction of Everolimus in De Novo Kidney Transplant Recipients, With a Follow-up Evaluation at 12 Months After Transplant (NEVERWOUND Study).","BACKGROUND


The risk of wound healing complications (WHCs) and the early use of mammalian target of rapamycin inhibitors after kidney transplantation (KT) have not been fully addressed.
METHODS


The NEVERWOUND study is a 3-month, multicenter, randomized, open-label study designed to evaluate whether a delayed (ie, 28 ± 4 d posttransplant) immunosuppression regimen based on everolimus (EVR) reduces the risk of WHC versus EVR started immediately after KT. Secondary endpoints were treatment failure (biopsy-proven acute rejection, graft loss, or death), delayed graft function, patient and graft survival rates, and renal function.
RESULTS


Overall, 394 KT recipients were randomized to receive immediate (N = 197) or delayed (N = 197) EVR after KT. At 3 months, WHC-free rates in the immediate EVR versus delayed EVR arm, considering the worst- and best-case scenario approach, were 0.68 (95% confidence interval [CI], 0.62-0.75) versus 0.62 (95% CI, 0.55-0.68) (log-rank P = 0.56) and 0.70 (95% CI, 0.64-0.77) versus 0.72 (95% CI, 0.65-0.78) (log-rank P = 0.77), respectively. The 3- and 12-month treatment failure rates, delayed graft function and renal function, and patient and graft survival were not different between the arms.
CONCLUSIONS


The early introduction of EVR after KT did not increase the risk of WHC, showing good efficacy and safety profile.",2020,"The early introduction of EVR after KT did not increase the risk of WHC, showing good efficacy and safety profile.","['394 KT recipients', 'de novo kidney transplant recipients, with a follow-up evaluation at 12 month after transplant (NEVERWOUND study']","['mTORi after Kidney Transplantation (KT', 'everolimus']","['treatment failure (biopsy-proven acute rejection, graft loss or death); Delayed Graft Function (DGF); patient and graft survival rates; renal function', 'WHC-free rates', 'risk of WHC', 'failure rates, DGF and renal function, as well as patient and graft survival', 'wound healing']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0162643'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",,0.0893548,"The early introduction of EVR after KT did not increase the risk of WHC, showing good efficacy and safety profile.","[{'ForeName': 'Tommaso Maria', 'Initials': 'TM', 'LastName': 'Manzia', 'Affiliation': 'Fondazione Policlinico Tor Vergata, Dipartimento Scienze Chirurgiche, Università degli Studi di Roma Tor Vergata, Roma, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Carmellini', 'Affiliation': 'AOU Senese, Siena, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Todeschini', 'Affiliation': 'Dipartimento di Medicina Specialistica diagnostica e sperimentale, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Secchi', 'Affiliation': 'Vita Salute San Raffaele University, Milano, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Sandrini', 'Affiliation': 'AO Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Minetti', 'Affiliation': 'AOU Careggi, Firenze, Italy.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Furian', 'Affiliation': 'AOU di Padova, Padova, Italy.'}, {'ForeName': 'Gionata', 'Initials': 'G', 'LastName': 'Spagnoletti', 'Affiliation': 'PU A.Gemelli, Roma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pisani', 'Affiliation': ""POU S.Salvatore, L'Aquila, Italy.""}, {'ForeName': 'Gian Benedetto', 'Initials': 'GB', 'LastName': 'Piredda', 'Affiliation': 'AO G.Brotzu, Cagliari, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Cappelli', 'Affiliation': 'AOUP di Modena, Modena, Italy.'}, {'ForeName': 'GIuseppe', 'Initials': 'G', 'LastName': 'Tisone', 'Affiliation': 'Fondazione Policlinico Tor Vergata, Dipartimento Scienze Chirurgiche, Università degli Studi di Roma Tor Vergata, Roma, Italy.'}]",Transplantation,['10.1097/TP.0000000000002851']
3310,31741168,A randomized trial comparing health-related quality-of-life and utility measures between routine fine-needle aspiration cytology (FNAC) and surveillance alone in patients with thyroid incidentaloma measuring 1-2 cm.,"PURPOSE


To present the impact of treatment on health-related quality-of-life (HRQOL) and health utility measures from the randomized controlled trial (ClinicalTrials.gov Identifier: NCT02398721) that investigated the FNAC versus watchful surveillance in patients with incidental benign thyroid nodules.
METHODS


Health utility and HRQOL were evaluated using the EQ-5D 5-level (EQ-5D-5L), 6-item Short-Form Health Survey (SF-6D), and generic 12-item Short-Form Health Survey (SF-12v2) at baseline, 3-month, 6-month, and 12-month assessments. A repeated measure analysis of variance evaluated differences in HRQOL scores between treatment groups over time. Multiple imputations were used to impute missing data at each time point.
RESULTS


HRQOL data completion rates were 99.7% at baseline, 92.7% at 3-month, 93.9% at 6-month, 92.7% at 12-month, and 88.6% at 18-month follow-up after baseline. There were significant mean differences in SF-6D, EQ-5D-5L, and SF-12v2 over time except the domain of vitality and mental health of SF-12v2. Mean change of SF-12v2 scores and utility scores from baseline between groups did not exceed minimal important difference. No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 (p value = 0.033; 0.024).
CONCLUSIONS


When compared with watchful surveillance, FNAC intervention was associated with better vitality and physical-related HRQOL scores but did not provide better preservation of utility score improvement over the 18-month period. These findings support the routine FNAC approach for nodules that have a low-suspicion sonographic pattern and measure between 1.0 and 2.0 cm.",2020,"No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 (p value = 0.033; 0.024).
","['patients with incidental benign thyroid nodules', 'patients with thyroid incidentaloma measuring 1-2\u2009cm']","['FNAC', 'routine fine-needle aspiration cytology (FNAC']","['HRQOL scores', 'EQ-5D 5-level (EQ-5D-5L), 6-item Short-Form Health Survey (SF-6D), and generic 12-item Short-Form Health Survey (SF-12v2', 'vitality domain and PCS of SF-12v2', 'HRQOL data completion rates', 'health-related quality-of-life (HRQOL) and health utility measures', 'Mean change of SF-12v2 scores and utility scores', 'better vitality and physical-related HRQOL scores', 'SF-6D, EQ-5D-5L, and SF-12v2 over time except the domain of vitality and mental health of SF-12v2', 'HRQOL and utility scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0749467', 'cui_str': 'Benign thyroid nodule'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}, {'cui': 'C0010820', 'cui_str': 'cytology'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0837596,"No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 (p value = 0.033; 0.024).
","[{'ForeName': 'Carlos K H', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Rm 1-01, 1/F, Jockey Club Building for Interdisciplinary Research, 5 Sassoon Road, Pokfulam, Hong Kong SAR, China. carlosho@hku.hk.'}, {'ForeName': 'Brian H H', 'Initials': 'BHH', 'LastName': 'Lang', 'Affiliation': 'Division of Endocrine Surgery, Department of Surgery, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}]",Endocrine,['10.1007/s12020-019-02129-y']
3311,31374304,"Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm 2  on the chest: A phase 3 randomized controlled trial.","BACKGROUND


Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm 2  or less; some patients require treatment of larger fields.
OBJECTIVE


To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm 2  during an 8-week initial assessment period and extended 12-month follow-up.
METHODS


This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm 2 ) or chest (approximately 250 cm 2 ). Patients received once-daily IngMeb or vehicle for 3 consecutive days on the full face, full balding scalp, or approximately 250 cm 2  on the chest. The primary endpoint was complete AK clearance (AKCLEAR 100; week 8). Additional endpoints included partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcome, and safety.
RESULTS


IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P < .001) and AK clearance of 75% or greater (59.4% vs 8.9%, P < .001) at week 8. Probability of sustained clearance during the 12-month follow-up was 22.9% for patients treated with IngMeb. Increased treatment satisfaction and cosmetic outcomes were observed with IngMeb versus vehicle. No unexpected safety signals were identified.
LIMITATIONS


Localized skin responses hindered maintenance of double-blinding.
CONCLUSIONS


IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm 2 . The safety profile of IngMeb was as expected.",2020,Probability of sustained clearance during 12-month follow-up was 22.9% for IngMeb-treated patients.,"['areas of AK ≤250 cm 2  during an eight-week initial assessment period and extended 12-month follow-up', 'actinic keratosis on full face, balding scalp or approximately 250 cm 2  on the chest', 'enrolled adult patients with 5-20 AK lesions on the face/scalp (25-250cm 2 ) or chest (∼250cm 2 ']",['ingenol mebutate gel'],"['treatment-satisfaction and cosmetic outcomes', 'partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcome and safety', 'Efficacy and safety', 'AK clearance', 'Probability of sustained clearance']","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0574769', 'cui_str': 'Loss of scalp hair (finding)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.269851,Probability of sustained clearance during 12-month follow-up was 22.9% for IngMeb-treated patients.,"[{'ForeName': 'C William', 'Initials': 'CW', 'LastName': 'Hanke', 'Affiliation': 'Laser and Skin Surgery Center of Indiana, Carmel, Indiana. Electronic address: cwmhanke@thelassi.com.'}, {'ForeName': 'Lorne', 'Initials': 'L', 'LastName': 'Albrecht', 'Affiliation': 'Enverus Medical, Surrey, British Columbia, Canada.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Skov', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Larsson', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Østerdal', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research, Brisbane, Queensland, Australia.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.083']
3312,29481457,Effect of a Hamstring Flexibility Program Performed Concurrently During an Elite Canoeist Competition Season.,"Álvarez-Yates, T and García-García, O. Effect of a hamstring flexibility program performed concurrently during an elite canoeist competition season. J Strength Cond Res 34(3): 838-846, 2020-The aim of this study was to determine the acute effect of an 8-week specific hamstring flexibility training on junior canoeist during the competition season. Sixteen canoeists participated, divided into 3 groups: 5 in experimental group 1 (EG1), 5 in experimental group 2 (EG2), and 6 in a control group. The EG1 underwent a supervised program consisted by simple static stretching, dynamic static stretching, and proprioceptive neuromuscular facilitation (PNF), whereas the EG2 performed a program without PNF and no supervision. Two measurements were performed to analyze the effect on the knee joint range of motion (ROM) and trunk flexion; neuromuscular and contractile properties in biceps femoris (BF) and semitendinosus (ST) muscles; and maximum power and average speed in lower limbs. A mixed-design factorial analysis of variance (p ≤ 0.05) was performed and the effect size was calculated. The results show significant improvements (p ≤ 0.05) in both legs for knee joint ROM and trunk flexion in EG1 (8.9 and 25.5%; 5.7 and 20.9% in the right and left leg, respectively) and EG2 (6.7 and 22%; 3.9 and 24.4%), only EG1 improved muscular stiffness in BF (27.4% left leg) and ST (20.5 and 24.3%), and lateral symmetry in BF (49%) without decreasing average speed in lower limbs. All improvements have a large effect size. In conclusion, it is suggested that a supervised hamstring flexibility program performed concurrently during a canoeist competition season can produce an increase in the knee joint ROM and trunk flexion, without negative repercussions in contractile and neuromuscular capacities, maximum power, and average velocity in lower limbs.",2020,"The results show significant improvements (p <0.05) in both legs for knee joint ROM and trunk flexion in EG1 (8.9% and 25.5%; 5.7% and 20.9% in right and left leg respectively) and EG2 (6.7% and 22%; 3.9% and 24.4%), only EG1 improved muscular stiffness in BF (27.4% left leg) and ST (20.5% and 24.3%), and lateral symmetry in BF (49%) without decreasing average speed in lower limbs.","['junior canoeist during the competition season', 'elite canoeist competition season', 'Sixteen canoeists participated, divided into 3 groups']","['5 in Experimental Group 1 (EG1), 5 in Experimental Group 2 (EG2) and 6 in a Control Group (CG', 'hamstring flexibility program', 'supervised program consisted by Simple Static Stretching, Dynamic Static Stretching and P.N.F. while the EG2 performed a program without P.N.F. and no supervision', 'specific hamstring flexibility training']","['muscular stiffness in BF', 'knee joint ROM and trunk flexion; neuromuscular and contractile properties in Biceps Femoris (BF) and Semitendinosus (ST) muscles; maximum power and average speed in lower limbs', 'knee joint ROM and trunk flexion in EG1', 'knee joint ROM and trunk flexion']","[{'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",16.0,0.0167168,"The results show significant improvements (p <0.05) in both legs for knee joint ROM and trunk flexion in EG1 (8.9% and 25.5%; 5.7% and 20.9% in right and left leg respectively) and EG2 (6.7% and 22%; 3.9% and 24.4%), only EG1 improved muscular stiffness in BF (27.4% left leg) and ST (20.5% and 24.3%), and lateral symmetry in BF (49%) without decreasing average speed in lower limbs.","[{'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Álvarez-Yates', 'Affiliation': 'Laboratory of Sports Performance, Physical Condition and Wellness, Faculty of Education and Sport Sciences, University of Vigo, Pontevedra, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'García-García', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002523']
3313,31337414,"Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe's voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial.","BACKGROUND


Surgical male circumcision (MC) safely reduces risk of female-to-male HIV-1 transmission by up to 60%. The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC without incident. To reach the 2016 global MC target of 20 million, productivity must double in countries plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care and has performed over 120,000 MCs. MC care in Zimbabwe requires in-person, follow-up visits at post-operative days 2,7, and 42. The ZAZIC program AE rate is 0.4%; therefore, overstretched clinic have staff conducted more than 200,000 unnecessary reviews of MC clients without complications.
METHODS


Through an un-blinded, prospective, randomized, controlled trial in two high-volume MC facilities, we will compare two groups of adult MC clients with cell phones, randomized 1:1 into two groups: (1) routine care (control group, N = 361) and (2) clients who receive and respond to a daily text with in-person follow up only if desired or if a complication is suspected (intervention group, N = 361). If an intervention client responds affirmatively to any automated daily text with a suspected AE, an MC nurse will exchange manual, modifiable, scripted texts with the client to determine symptoms and severity, requesting an in-person visit if desired or warranted. Both arms will complete a study-specific, day 14, in-person, follow-up review for verification of self-reports (intervention) and comparison (control). Data collection includes extraction of routine client MC records, study-specific database reports, and participant usability surveys. Intent-to-treat (ITT) analysis will be used to explore differences between groups to determine if two-way texting (2wT) can safely reduce MC follow-up visits, estimate the cost savings associated with 2wT over routine MC follow up, and assess the acceptability and feasibility of 2wT for scale up.
DISCUSSION


It is expected that this mobile health intervention will be as safe as routine care while providing distinct advantages in efficiency, costs, and reduced healthcare worker burden. The success of this intervention could lead to adaptation and adoption of this intervention at the national level, increasing the efficiency of MC scale up, and reducing burdens on providers and patients.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03119337 . Registered on 18 April 2017.",2019,The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC without incident.,"['adult MC clients with cell phones', 'two high-volume MC facilities', ""Zimbabwe's voluntary medical male circumcision program""]","['routine care (control group, N\u2009=\u2009361) and (2) clients who receive and respond to a daily text with in-person follow up only if desired or if a complication is suspected (intervention', 'Surgical male circumcision (MC']",['average rate of global moderate and severe adverse events'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2016.0,0.132818,The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC without incident.,"[{'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Feldacker', 'Affiliation': 'International Training and Education Center for Health (I-TECH), 325 9th Avenue, HMC#359932, Seattle, WA, 98104-2499, USA. cfeld@uw.edu.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Murenje', 'Affiliation': 'International Training and Education Center for Health (I-TECH)/Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Barnhart', 'Affiliation': 'International Training and Education Center for Health (I-TECH), 325 9th Avenue, HMC#359932, Seattle, WA, 98104-2499, USA.'}, {'ForeName': 'Sinokuthemba', 'Initials': 'S', 'LastName': 'Xaba', 'Affiliation': 'Zimbabwe Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Makunike-Chikwinya', 'Affiliation': 'International Training and Education Center for Health (I-TECH)/Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Holeman', 'Affiliation': 'Medic Mobile, 3254 19th Street, Floor Two, San Francisco, CA, 94110, USA.'}, {'ForeName': 'Mufuta', 'Initials': 'M', 'LastName': 'Tshimanga', 'Affiliation': 'Zimbabwe Community Health Intervention Project (ZiCHIRe), Harare, Zimbabwe.'}]",Trials,['10.1186/s13063-019-3470-9']
3314,31682162,Phase II Study of Single/Repeated Doses of Acumapimod (BCT197) to Treat Acute Exacerbations of COPD.,"Mitogen-activated protein kinase p38 is a key regulator in the inflammation pathway and is activated in the lungs of chronic obstructive pulmonary disease (COPD) patients. Acumapimod is a potent, selective, oral, p38 inhibitor under investigation for treatment of acute exacerbations of COPD (AECOPD). In this Phase II, double-blind, randomized, placebo-controlled dose-exploration study of acumapimod in patients with moderate or severe AECOPD (NCT01332097), patients presenting with AECOPD were randomized to receive single-dose acumapimod (20 mg or 75 mg) on Day 1, repeated single-dose acumapimod (20 mg or 75 mg) on Days 1 and 6, oral prednisone 40 mg (10 days), or placebo. Primary outcome: improvement in forced expiratory volume in 1 s (FEV 1 ) versus placebo at Day 5 (single doses) and Day 10 (repeated doses).  N  = 183 patients were randomized; 169 (92%) patients completed the study. Although the primary endpoint (FEV 1  at Day 10) was not met ( p  = 0.082), there was a significant improvement in FEV 1  with acumapimod repeat-dose 75 mg versus placebo at Day 8 ( p  = 0.022) which, though not a prespecified endpoint, was part of an overall trend. Differences at lower doses did not achieve significance. Mean change in FEV 1  AUC from baseline to Day 14 in the 75 mg repeat-dose group was significantly higher versus placebo ( p  = 0.02), prednisone ( p  = 0.01), and 20 mg single-dose groups ( p  = 0.015) (post-hoc analysis). EXACT-PRO showed numerical differences versus placebo that did not reach significance. Acumapimod was well tolerated. In conclusion, repeated single-dose acumapimod showed a clinically relevant improvement in FEV 1  over placebo at Day 8, along with consistent numerical differences in EXACT-PRO. These data can be used to determine dose regimens for a proof-of-clinical-concept trial.",2019,"Although the primary endpoint (FEV 1  at Day 10) was not met ( p  = 0.082), there was a significant improvement in FEV 1  with acumapimod repeat-dose 75 mg versus placebo at Day 8 ( p  = 0.022) which, though not a prespecified endpoint, was part of an overall trend.","['patients with moderate or severe AECOPD (NCT01332097), patients presenting with AECOPD', '183 patients were randomized; 169 (92%) patients completed the study', 'chronic obstructive pulmonary disease (COPD) patients']","['Acumapimod (BCT197', 'placebo', 'acumapimod', 'prednisone', 'single-dose acumapimod (20\u2009mg or 75\u2009mg) on Day 1, repeated single-dose acumapimod (20\u2009mg or 75\u2009mg) on Days 1 and 6, oral prednisone 40\u2009mg (10\u2009days), or placebo']","['FEV', 'tolerated', 'forced expiratory volume in 1\u2009s (FEV 1 ) versus placebo at Day 5 (single doses) and Day 10 (repeated doses', 'Mean change in FEV 1  AUC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",183.0,0.439563,"Although the primary endpoint (FEV 1  at Day 10) was not met ( p  = 0.082), there was a significant improvement in FEV 1  with acumapimod repeat-dose 75 mg versus placebo at Day 8 ( p  = 0.022) which, though not a prespecified endpoint, was part of an overall trend.","[{'ForeName': 'Irina R', 'Initials': 'IR', 'LastName': 'Strâmbu', 'Affiliation': 'National Institute of Pneumology ""Marius Nasta"", Bucharest, Romania.'}, {'ForeName': 'Zhanna D', 'Initials': 'ZD', 'LastName': 'Kobalava', 'Affiliation': 'Department of Internal Medicine, RUDN University, Moscow, Russia.'}, {'ForeName': 'Baldur P', 'Initials': 'BP', 'LastName': 'Magnusson', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'MacKinnon', 'Affiliation': 'Mereo BioPharma Group plc, London, UK.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Parkin', 'Affiliation': 'Mereo BioPharma Group plc, London, UK.'}]",COPD,['10.1080/15412555.2019.1682535']
3315,31918584,Patients' Satisfaction With the Therapeutic Relationship and Therapeutic Outcome Is Related to Suicidal Ideation in the Attempted Suicide Short Intervention Program (ASSIP).,"Background:  The therapeutic alliance may be a moderating factor of outcome in the Attempted Suicide Short Intervention Program (ASSIP).  Aims:  This study investigates the two components of the therapeutic alliance, patients' satisfaction with the therapeutic relationship and therapeutic outcome and their associations with suicidal ideation over time.  Method:  A total of 120 patients (55% female; mean age = 36 years) with a history of attempted suicide were randomly allocated to either the intervention group ( N  = 60) or the control group ( N  = 60). Patients' satisfaction with the therapeutic relationship and outcome were measured with the two subscales of the Helping Alliance Questionnaire. The Beck Scale of Suicide Ideation was used to measure suicidal ideation in this 24-month follow-up study.  Results:  The ASSIP group showed that patients' satisfaction with therapeutic relationship and outcome increased significantly from the first to the third session. Higher satisfaction with therapeutic outcome correlated significantly with lower suicidal ideation at follow-up. Conversely, the control group showed no significant results.  Limitations:  The collaborative approach adopted in the initial clinical interview of the control group could possibly have influenced the results of both scales.  Conclusion:  In particular, the component satisfaction with therapeutic outcome seems crucial to the subjectively perceived satisfaction of treatment and is associated with lower suicidal ideation over time. Thus, an enhanced understanding of components of the therapeutic alliance plays an important role in the development of interventions for suicidal patients.",2020,The ASSIP group showed that patients' satisfaction with therapeutic relationship and outcome increased significantly from the first to the third session.,"['suicidal patients', '120 patients (55% female; mean age = 36 years) with a history of attempted suicide']",['ASSIP'],"['suicidal ideation', 'Beck Scale of Suicide Ideation']","[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0455507', 'cui_str': 'H/O: attempted suicide'}]",[],"[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0222045'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}]",120.0,0.0194618,The ASSIP group showed that patients' satisfaction with therapeutic relationship and outcome increased significantly from the first to the third session.,"[{'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Ring', 'Affiliation': 'Private Clinic Clienia Schlössli, Oetwil am See, Switzerland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gysin-Maillart', 'Affiliation': 'Translational Research Centre, University Hospital of Psychiatry, University of Bern, Switzerland.'}]",Crisis,['10.1027/0227-5910/a000644']
3316,31809308,"Brief Report: Anal Intercourse, HIV-1 Risk, and Efficacy in a Trial of a Dapivirine Vaginal Ring for HIV-1 Prevention.","OBJECTIVES


To describe receptive anal intercourse (RAI) behaviors and correlates in a cohort of sub-Saharan African women, evaluate the association of RAI with HIV-1 risk, and evaluate whether the HIV-1 prevention efficacy of a dapivirine vaginal ring differs among women who reported RAI.
DESIGN


Secondary analysis of the MTN-020/ASPIRE trial, a randomized, double-blind, placebo-controlled trial evaluating a dapivirine vaginal ring for HIV-1 prevention.
METHODS


At enrollment and month 3, women reported RAI in the prior 3 months in audio computer-assisted self-interviews. We evaluated associations between RAI and participant characteristics with χ and t-tests adjusted for study site. Cox proportional hazards models stratified by study site tested the association of RAI with HIV-1 acquisition and effect modification by RAI.
RESULTS


Eighteen percent of women reported any RAI at enrollment and/or month 3, with a median of 2 (interquartile range: 1-4) RAI acts in the prior 3 months, accounting for 1.5% of total sex acts. RAI prevalence was higher among women with lower educational attainment and those reporting transactional sex. In adjusted models, RAI was not associated with HIV-1 acquisition (aHR: 0.93, 95% CI: 0.57 to 1.54). The ring reduced HIV-1 risk by 27% (95% CI: -5 to 49) among women reporting no RAI and by 18% (95% CI: -57 to 57) among women reporting any RAI (interaction P-value = 0.77).
CONCLUSIONS


RAI was modestly infrequent and was not associated with reduced HIV-1 protection from the ring, suggesting that, in populations with rates of RAI similar to this cohort, RAI may not appreciably reduce the population-level impact of the dapivirine vaginal ring.",2020,"The ring reduced HIV-1 risk by 27% (95% CI: -5, 49) among women reporting no RAI and by 18% (95% CI: -57, 57) among women reporting any RAI (interaction p-value=0.77).
",['women who reported RAI'],"['dapivirine-containing vaginal ring for HIV-1 prevention', 'dapivirine-containing vaginal ring', 'placebo']","['HIV-1 risk', 'RAI prevalence', 'receptive anal intercourse (RAI) behaviors', 'Anal intercourse, HIV-1 risk, and efficacy', 'HIV-1 protection']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.333294,"The ring reduced HIV-1 risk by 27% (95% CI: -5, 49) among women reporting no RAI and by 18% (95% CI: -57, 57) among women reporting any RAI (interaction p-value=0.77).
","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Peebles', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""RTI International, Women's Global Health Imperative (WGHI), San Francisco, CA.""}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine (Clinical Pharmacology), Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ishana', 'Initials': 'I', 'LastName': 'Harkoo', 'Affiliation': 'Centre for the AIDS Program of Research in South Africa, Durban, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Gati Mirembe', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Nitesha', 'Initials': 'N', 'LastName': 'Jeenarain', 'Affiliation': 'South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002253']
3317,31875687,Effects of the introduction of objective criteria for referral and discharge in physical therapy for ischemic stroke in China: a randomized controlled trial.,"OBJECTIVE


To examine the effectiveness of a set of rules for referral and therapy input in a three-tiered physiotherapy program on activities of daily living (ADL), motor function, and quality of life of stroke survivors.
DESIGN


Randomized controlled study.
SETTING


Rehabilitation departments of 11 teaching hospitals.
SUBJECTS


A total of 285 participants with stroke.
OUTCOME MEASURES


Primary outcome was ADL independence measured with the Modified Barthel Index (MBI) at weeks 3, 6, 9, 13, and 17. Secondary outcomes were motor function and quality of life measured with Fugel-Meyer Assessment (FMA) and Stroke-Specific Quality-of-Life (SSQOL) scale.
INTERVENTION


Two complementary sets of rules governing rehabilitation delivery were introduced: a set of criteria that determined when someone ought to move from tier 1 onto tier 2, and from tier 2 onto tier 3, and a second set of rules that determined the amount and type of physiotherapy input given in each tier. Control group participants received conventional rehabilitation without any specified guidelines.
RESULTS


With a difference of 3.97 (95% confidence interval (CI): 1.59-6.36), MBI increased stronger in the study group than in controls between baseline and week 3 ( P  = 0.001). This difference could be sustained until study end-point. No significant differences were found for FMA. Differences in increase of SSQOL were higher in the intervention than control at week 9 ( P  < 0.05).
CONCLUSION


Introduction of a set of rules for referral and therapy input at different stages of rehabilitation partially improved patients' ADL and quality of life, but did not improve motor function.",2020,"Differences in increase of SSQOL were higher in the intervention than control at week 9 ( P  < 0.05).
","['Rehabilitation departments of 11 teaching hospitals', '285 participants with stroke', 'ischemic stroke in China']","['conventional rehabilitation without any specified guidelines', 'physical therapy']","['MBI', 'FMA', 'ADL independence measured with the Modified Barthel Index (MBI', 'SSQOL', 'motor function', 'motor function and quality of life measured with Fugel-Meyer Assessment (FMA) and Stroke-Specific Quality-of-Life (SSQOL) scale', ""patients' ADL and quality of life"", 'activities of daily living (ADL), motor function, and quality of life of stroke survivors']","[{'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",285.0,0.147418,"Differences in increase of SSQOL were higher in the intervention than control at week 9 ( P  < 0.05).
","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Xia', 'Affiliation': 'Center of Rehabilitation Medicine, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jan D', 'Initials': 'JD', 'LastName': 'Reinhardt', 'Affiliation': 'Institute for Disaster Management and Reconstruction, Sichuan University and Hong Kong Polytechnic University, Chengdu, China.'}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Center of Rehabilitation Medicine, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation Medicine, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Caili', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Rehabilitation Medicine, Wuxi Tongren International Rehabilitation Hospital, Wuxi, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Center of Rehabilitation Medicine, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Center of Rehabilitation Medicine, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.'}]",Clinical rehabilitation,['10.1177/0269215519896014']
3318,31962191,"Effects of a foot strengthening program on foot muscle morphology and running mechanics: A proof-of-concept, single-blind randomized controlled trial.","OBJECTIVES


To investigate the effects of a foot training program on muscle morphology and strength as well as running biomechanics in healthy recreational runners.
DESIGN


Proof-of-concept, single-blind randomized controlled trial.
SETTINGS


Runners were allocated to a control (CG) or an intervention (IG) group. The intervention focused on strengthening the intrinsic foot muscles and their activation during weight-bearing activities. All participants were assessed at baseline and after 8-weeks.
PARTICIPANTS


Twenty-eight healthy recreational long-distance runners not habituated to minimalist running shoes or barefoot running.
MAIN OUTCOMES MEASURES


Outcomes were hallux and toes strength; foot function, cross-sectional area and volume of the abductor hallucis (ABH), abductor digiti minimi (ABV), flexor digitorum brevis (FDB), and flexor hallucis brevis; medial longitudinal arch range of motion and stiffness; vertical and antero-posterior propulsive impulses during running.
RESULTS


Compared to the CG, an increase was found in the IG for the volume of all muscles investigated and for vertical propulsive impulse during running. Correlations were found between vertical propulsive impulse and volume of ABH(r = 0.40), ABV(r = 0.41), and FDB(r = 0.69).
CONCLUSION


The foot exercise protocol effectively increased intrinsic foot muscle volume and propulsive forces in recreational runners. This shows that intrinsic muscle strengthening affects running mechanics and suggests that it may improve running performance.",2020,"Compared to the CG, an increase was found in the IG for the volume of all muscles investigated and for vertical propulsive impulse during running.","['Twenty-eight healthy recreational long-distance runners not habituated to minimalist running shoes or barefoot running', 'Runners', 'healthy recreational runners', 'recreational runners']","['foot training program', 'control (CG) or an intervention (IG', 'foot strengthening program']","['intrinsic foot muscle volume and propulsive forces', 'hallux and toes strength; foot function, cross-sectional area and volume of the abductor hallucis (ABH), abductor digiti minimi (ABV), flexor digitorum brevis (FDB), and flexor hallucis brevis; medial longitudinal arch range of motion and stiffness; vertical and antero-posterior propulsive impulses during running', 'foot muscle morphology and running mechanics']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0018534', 'cui_str': 'Big Toe'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}]",28.0,0.0498021,"Compared to the CG, an increase was found in the IG for the volume of all muscles investigated and for vertical propulsive impulse during running.","[{'ForeName': 'Ulisses T', 'Initials': 'UT', 'LastName': 'Taddei', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, Cidade Universitária, Rua Cipotânea 51, São Paulo, Brazil. Electronic address: ulisses.taddei@usp.br.'}, {'ForeName': 'Alessandra B', 'Initials': 'AB', 'LastName': 'Matias', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, Cidade Universitária, Rua Cipotânea 51, São Paulo, Brazil. Electronic address: alessandra.matias@usp.br.'}, {'ForeName': 'Fernanda I A', 'Initials': 'FIA', 'LastName': 'Ribeiro', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, Cidade Universitária, Rua Cipotânea 51, São Paulo, Brazil. Electronic address: fernanda.iacovanduano@gmail.com.'}, {'ForeName': 'Sicco A', 'Initials': 'SA', 'LastName': 'Bus', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, Amsterdam, the Netherlands. Electronic address: s.a.bus@amc.uva.nl.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, Cidade Universitária, Rua Cipotânea 51, São Paulo, Brazil. Electronic address: icnsacco@usp.br.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.01.007']
3319,32060552,Cognitive Distraction at Mealtime Decreases Amount Consumed in Healthy Young Adults: A Randomized Crossover Exploratory Study.,"BACKGROUND


Environmental distractions have been shown to affect eating patterns.
OBJECTIVE


The purpose of this study was to determine the effects of a cognitive distraction on amount, preference, and memory of food consumed and perceptions of fullness, hunger, and enjoyment of food in a healthy young-adult population.
METHODS


A randomized controlled crossover study of 119 healthy adults (20.2 ± 1.4 y; 57% women; 48% white) assigned participants to begin under either the distracted (DIS, n = 55) or control (CON, n = 64) conditions. DIS participants consumed a meal of quiche while completing a Rapid Visual Information Processing (RVIP) for 15 min. CON participants ate without any task assignment. After a 30-min rest period, participants were offered a snack and given 5 min to eat ad libitum. Participants completed a survey assessing fullness, hunger, and enjoyment of the meal using 100 mm visual analogue scales. One week later, participants completed the opposite condition. Data were analyzed using ANOVA.
RESULTS


Those in DIS consumed 13 g less of the meal (P < 0.001), even when comparing by initial condition (P < 0.001) and adjusting for sex (P < 0.001). A carryover effect of initial condition was found (P < 0.001), such that participants first assigned to DIS condition consumed less (95.2 ± 61.7 g) when distracted compared to all other condition combinations (127-133 g). Those in DIS had decreased accuracy for both memory of quiche received (absolute difference, 1.1 ± 1.6 compared with 0.7 ± 1.2 for CON, P < 0.001) and memory of quiche consumed (0.8 ± 1.1 for DIS compared with 0.7 ± 1.2 for CON, P = 0.007).
CONCLUSIONS


When distracted, healthy young adults consumed significantly less food and their memory of the meal was dampened. These findings underscore the potential importance of cognitive distraction in affecting food intake. This trial was registered at clinicaltrials.gov as NCT04078607.",2020,"Those in DIS consumed 13 g less of the meal (P < 0.001), even when comparing by initial condition (P < 0.001) and adjusting for sex (P ","['healthy young-adult population', '119 healthy adults (20.2\xa0±', 'healthy young adults', 'Healthy Young Adults']","['Cognitive Distraction at Mealtime', 'cognitive distraction', 'CON']","['survey assessing fullness, hunger, and enjoyment of the meal using 100\xa0mm visual analogue scales', 'amount, preference, and memory of food consumed and perceptions of fullness, hunger, and enjoyment of food']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}]","[{'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",119.0,0.164718,"Those in DIS consumed 13 g less of the meal (P < 0.001), even when comparing by initial condition (P < 0.001) and adjusting for sex (P ","[{'ForeName': 'Carli A', 'Initials': 'CA', 'LastName': 'Liguori', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, IL, USA.'}, {'ForeName': 'Cassandra J', 'Initials': 'CJ', 'LastName': 'Nikolaus', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, IL, USA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Nickols-Richardson', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa022']
3320,31036259,Visuospatial computer game play after memory reminder delivered three days after a traumatic film reduces the number of intrusive memories of the experimental trauma.,"OBJECTIVE


The experience of intrusive memories is a core clinical symptom of posttraumatic stress disorder (PTSD), and can be distressing in its own right. Notions of dual task interference and reconsolidation-update mechanisms suggest novel approaches to target intrusive memories. This study tested the hypothesis that a single-session cognitive intervention (memory reminder task plus Tetris gameplay) would reduce the occurrence of experimental trauma memories even when delivered 3 days post-trauma. Critically, this study tested effects against two control groups: Reminder-only, and reminder plus another computer game (a form of Quiz).
METHODS


86 healthy volunteers (59% female, age M = 24.35, SD = 4.59 years) watched a trauma film and then recorded their intrusive memories in a diary for 3 days (pre-intervention). They then returned to the lab. After presentation of visual reminder cues for the film plus a 10 min wait period (memory reminder task), participants were randomized into one of three task conditions (Tetris game play, Quiz game play, vs. reminder-only). They then kept the diary for a further 3 days (post-intervention).
RESULTS


As predicted, after the experimental manipulation, the reminder + Tetris group experienced significantly fewer intrusions than the reminder-only group (d = 1.37). Further, the reminder + Tetris group also experienced significantly fewer intrusions than the reminder + Quiz (d = 0.65) group. Contrary to predictions, the reminder + Quiz group experienced significantly fewer intrusions than the reminder-only group (d = 0.69). Prior to the experimental manipulation, there was no significant difference between groups in number of intrusions. Recognition memory test scores for facts of the trauma film after 6 days were comparable between groups.
CONCLUSIONS


We demonstrated that 3 days after experimental trauma (i.e. after memory consolidation) an intervention comprising a reminder task prior to a 15 min cognitive interference task (one of two computer games) led to a reduction in intrusion occurrence compared to reminder only. We interpret and discuss our findings within the framework of supposed reconsolidation-update mechanisms and competition for limited (visuospatial) working memory resources. Should these effects hold true in clinical populations, this type of simple intervention approach could help contribute to reducing intrusive memories of trauma.",2020,"Contrary to predictions, the reminder + Quiz group experienced significantly fewer intrusions than the reminder-only group (d = 0.69).","['age M', '86 healthy volunteers (59% female']","['three task conditions (Tetris game play, Quiz game play, vs. reminder-only', 'single-session cognitive intervention (memory reminder task plus Tetris gameplay']","['occurrence of experimental trauma memories', 'number of intrusive memories', 'number of intrusions']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}]",86.0,0.0674042,"Contrary to predictions, the reminder + Quiz group experienced significantly fewer intrusions than the reminder-only group (d = 0.69).","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kessler', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr-University Bochum, Bochum, Germany. Electronic address: Henrik.Kessler@ruhr-uni-bochum.de.'}, {'ForeName': 'Anna-Christine', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Ella L', 'Initials': 'EL', 'LastName': 'James', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Blackwell', 'Affiliation': 'Mental Health Research and Treatment Center, Faculty of Psychology, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'von Rauchhaupt', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Harren', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Kehyayan', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Clark', 'Affiliation': 'Wellcome Trust Centre for Neuroimaging, Institute of Neurology, University College London, London, United Kingdom.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Sauvage', 'Affiliation': 'Leibniz Institute for Neurobiology, Functional Architecture of Memory Department, Magdeburg, Germany; Otto-von-Guericke-University Magdeburg, Medical Faculty, Magdeburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Herpertz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Axmacher', 'Affiliation': 'Department of Neuropsychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Sweden; Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Sweden.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.01.006']
3321,31072599,Rescripting experimental trauma: Effects of imagery and writing as a way to reduce the development of intrusive memories.,"BACKGROUND AND OBJECTIVES


Imagery rescripting is an effective treatment strategy for trauma related disorders, but its underlying mechanisms are still largely unknown. The aim of the present study was to test whether a) imagery (versus writing) is essential in the process of rescripting, and b) rescripting affects emotional memories on an implicit level.
METHODS


Healthy participants were subjected to an experimental trauma ('trauma film'), and randomly allocated to four conditions: recall of film + Imagery Rescripting (ImRs), recall of film + Writing Rescripting (WRs), recall only (ImRE), or no recall + no manipulation (NM). Next, participants recorded intrusion frequency and distress during one week, after which they executed a visual interference task (VIT) including neutral and trauma film stills, to access implicit emotional memory.
RESULTS


Main findings were that ImRs and WRs resulted in fewer intrusions than NM, with no differences between both rescripting conditions. We did not find an effect on intrusion distress and the VIT.
LIMITATIONS


Stills in the VIT were distracted from all four film scenes, whereas rescripting was done on one scene only, possibly obscuring the effect. Also, an analogue sample was used, which may limit generalizability to clinical samples.
CONCLUSIONS


We replicated previous effects of ImRs on intrusion development. Furthermore, no superior effect of imagery as key modality for rescripting was found; writing seems a viable alternative. Measures for implicit emotional memory such as the VIT may have to be applied relatively soon after the experimental session (e.g., same day as the experimental session).",2020,"RESULTS


Main findings were that ImRs and WRs resulted in fewer intrusions than NM, with no differences between both rescripting conditions.","[""Healthy participants were subjected to an experimental trauma ('trauma film""]","['visual interference task (VIT) including neutral and trauma film stills, to access implicit emotional memory', 'recall of film\xa0+\xa0Imagery Rescripting (ImRs), recall of film\xa0+\xa0Writing Rescripting (WRs), recall only (ImRE), or no recall\xa0+\xa0no manipulation (NM']","['development of intrusive memories', 'intrusion distress']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C4319646', 'cui_str': 'Film'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0726952,"RESULTS


Main findings were that ImRs and WRs resulted in fewer intrusions than NM, with no differences between both rescripting conditions.","[{'ForeName': 'Marleen M', 'Initials': 'MM', 'LastName': 'Rijkeboer', 'Affiliation': 'Maastricht University, Department of Clinical Psychological Science, Maastricht, the Netherlands. Electronic address: marleen.rijkeboer@maastrichtuniversity.nl.'}, {'ForeName': 'Jora J', 'Initials': 'JJ', 'LastName': 'Daemen', 'Affiliation': 'Altrecht Health Care Centre, Utrecht, the Netherlands.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Flipse', 'Affiliation': 'Altrecht Health Care Centre, Utrecht, the Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bouwman', 'Affiliation': 'Utrecht University, Department of Clinical Psychology, Utrecht, the Netherlands.'}, {'ForeName': 'Muriel A', 'Initials': 'MA', 'LastName': 'Hagenaars', 'Affiliation': 'Utrecht University, Department of Clinical Psychology, Utrecht, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.04.004']
3322,31912752,The effect of an integrated multidisciplinary rehabilitation programme alternating inpatient interventions with home-based activities for patients with chronic low back pain: a randomized controlled trial.,"OBJECTIVE


To compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain.
DESIGN


A single-centre, pragmatic, two-arm parallel, randomized controlled trial (1:1 ratio).
SETTING


A rheumatology inpatient rehabilitation centre in Denmark.
SUBJECTS


A total of 165 adults (aged ⩾ 18 years) with chronic low back pain.
INTERVENTIONS


An integrated rehabilitation programme comprising an alternation of three weeks of inpatient stay and 12 weeks of home-based activities was compared with an existing rehabilitation programme of four weeks of inpatient stay.
MAIN MEASURES


Patient-reported outcomes were collected at baseline and at the 26-week follow-up. The primary outcome was back-specific disability (Oswestry Disability Index). Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). A complete case analysis was performed.
RESULTS


A total of 303 patients were assessed for eligibility of whom 165 (mean age: 50 years (SD 13) and mean Oswestry Disability Index score 42 (SD 11)) were randomized (83 to existing rehabilitation programme and 82 to integrated rehabilitation programme). Overall, 139 patients provided the 26-week follow-up data. Baseline demographic and clinical characteristics were comparable between programmes. The between-group difference in the Oswestry Disability Index score when adjusting for the corresponding baseline score was -0.28 (95% confidence interval (CI): -4.02, 3.45) which was neither statistically nor clinically significant. No significant differences were found in the secondary outcomes.
CONCLUSION


An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.",2020,An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.,"['165 adults (aged\u2009⩾\u200918\u2009years) with chronic low back pain', 'A rheumatology inpatient rehabilitation centre in Denmark', '303 patients were assessed for eligibility of whom 165 (mean age: 50\u2009years (SD 13) and mean Oswestry Disability Index score 42 (SD 11', 'patients with chronic low back pain', '139 patients provided the 26-week follow-up data']","['existing rehabilitation programme and 82 to integrated rehabilitation programme', 'integrated rehabilitation programme with an existing rehabilitation programme', 'integrated multidisciplinary rehabilitation programme alternating inpatient interventions with home-based activities']","['pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory', 'Oswestry Disability Index score', 'back-specific disability (Oswestry Disability Index']","[{'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score (observable entity)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4075347', 'cui_str': 'PSEQ - Pain Self-efficacy Questionnaire'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score (observable entity)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",165.0,0.177391,An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.,"[{'ForeName': 'Anne Mette', 'Initials': 'AM', 'LastName': 'Schmidt', 'Affiliation': 'Department of Public Health, Centre for Rehabilitation Research, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Schiøttz-Christensen', 'Affiliation': 'Spine Centre of Southern Denmark, Lillebælt Hospital, Middelfart, Denmark.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Clinical Trials Unit, School of Primary, Community and Social Care, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK.'}, {'ForeName': 'Trine Bay', 'Initials': 'TB', 'LastName': 'Laurberg', 'Affiliation': 'Sano, Højbjerg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Maribo', 'Affiliation': 'Department of Public Health, Centre for Rehabilitation Research, Aarhus University, Aarhus, Denmark.'}]",Clinical rehabilitation,['10.1177/0269215519897968']
3323,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3324,31498393,Reboot Online: A Randomized Controlled Trial Comparing an Online Multidisciplinary Pain Management Program with Usual Care for Chronic Pain.,"OBJECTIVE


Chronic pain is a prevalent and burdensome condition. Reboot Online was developed to address treatment barriers traditionally associated with accessing face-to-face chronic pain management programs. It is a comprehensive multidisciplinary online treatment program, based on an existing and effective face-to-face multidisciplinary pain program (the Reboot program).
DESIGN & PARTICIPANTS


A CONSORT-compliant randomized controlled trial was conducted, enrolling adults who had experienced pain for three months or longer.
METHODS


Participants were randomly allocated to either an eight-lesson multidisciplinary pain management program, Reboot Online (N = 41), or to a usual care (UC) control group (N = 39). Clinical oversight was provided by a multidisciplinary team remotely, including physiotherapists and clinical psychologists. Participants were measured at baseline, post-treatment (week 16), and three-month follow-up (week 28).
RESULTS


Intention-to-treat analyses revealed that Reboot Online was significantly more effective than UC at increasing pain self-efficacy (g = 0.69) at post-treatment, and these gains were maintained at follow-up. Similarly, Reboot Online was significantly more effective than UC on several secondary measures at post-treatment and follow-up, including movement-based fear avoidance and pain-related disability, but it did not significantly reduce pain interference or depression compared with UC. Clinician input was minimal, and adherence to Reboot Online was moderate, with 61% of participants (N = 25) completing all eight lessons.
CONCLUSIONS


Reboot Online presents a novel approach to multidisciplinary pain management and offers an accessible, efficacious alternative and viable treatment option for chronic pain management.",2019,"RESULTS


Intention-to-treat analyses revealed that Reboot Online was significantly more effective than UC at increasing pain self-efficacy (g = 0.69) at post-treatment, and these gains were maintained at follow-up.","['Participants', 'enrolling adults who had experienced pain for three months or longer', 'Chronic Pain']","['Online Multidisciplinary Pain Management Program with Usual Care', 'eight-lesson multidisciplinary pain management program, Reboot Online (N\u2009=\u200941), or to a usual care (UC) control group', 'Reboot Online']","['pain self-efficacy', 'movement-based fear avoidance and pain-related disability', 'pain interference or depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.084072,"RESULTS


Intention-to-treat analyses revealed that Reboot Online was significantly more effective than UC at increasing pain self-efficacy (g = 0.69) at post-treatment, and these gains were maintained at follow-up.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression (CRUfAD), University of New South Wales at St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Faux', 'Affiliation': ""Department of Pain Medicine, St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Gardner', 'Affiliation': ""Department of Pain Medicine, St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Hobbs', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression (CRUfAD), University of New South Wales at St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Mathew A', 'Initials': 'MA', 'LastName': 'James', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression (CRUfAD), University of New South Wales at St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Joubert', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression (CRUfAD), University of New South Wales at St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Kladnitski', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression (CRUfAD), University of New South Wales at St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression (CRUfAD), University of New South Wales at St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Schultz', 'Affiliation': ""Department of Pain Medicine, St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Christine T', 'Initials': 'CT', 'LastName': 'Shiner', 'Affiliation': ""Department of Pain Medicine, St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Andrews', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression (CRUfAD), University of New South Wales at St Vincent's Hospital, Sydney, NSW, Australia.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz208']
3325,31633580,"Effects of visual feedback training and visual targets on muscle activation, balancing, and walking ability in adults after hemiplegic stroke: a preliminary, randomized, controlled study.","The aim of this randomized, controlled study was to investigate the effect of visual feedback through visual targets on muscle activity, balance, and gait in stroke patients. Patients were recruited from the inpatient unit of a rehabilitation hospital. Twenty-one patients who had experienced hemiplegic stroke were randomly assigned to two groups: an experimental group (visual feedback training with visual targets on gradual weight shifting), and a control group (visual feedback training on gradual weight shifting). All patients performed 30 minutes of comprehensive rehabilitation therapy followed by an additional 20 minutes of gradual weight shifting using visual feedback training with or without visual targets: three sets per day, five times a week, for 4 weeks. Significantly larger gains were identified in the experimental group compared to the control group due to gluteus medius muscle activation and the weight-bearing ability of the paretic side. Visual feedback training with visual targets during gradual weight bearing on the paretic side appears to improve the muscle activation and balancing abilities of hemiplegic stroke patients compared to visual feedback training alone.",2020,Significantly larger gains were identified in the experimental group compared to the control group due to gluteus medius muscle activation and the weight-bearing ability of the paretic side.,"['Patients were recruited from the inpatient unit of a rehabilitation hospital', 'stroke patients', 'adults after hemiplegic stroke', 'Twenty-one patients who had experienced hemiplegic stroke', 'hemiplegic stroke patients']","['comprehensive rehabilitation therapy followed by an additional 20 minutes of gradual weight shifting using visual feedback training with or without visual targets', 'experimental group (visual feedback training with visual targets on gradual weight shifting), and a control group (visual feedback training on gradual weight shifting', 'visual feedback training alone', 'visual feedback through visual targets', 'Visual feedback training', 'visual feedback training and visual targets']","['muscle activation, balancing, and walking ability', 'muscle activity, balance, and gait']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",,0.0282058,Significantly larger gains were identified in the experimental group compared to the control group due to gluteus medius muscle activation and the weight-bearing ability of the paretic side.,"[{'ForeName': 'Noh-Wook', 'Initials': 'NW', 'LastName': 'Pak', 'Affiliation': 'Department of Physical Therapy, Rehabilitation Center, Bonifacio Hospital, Daejeon City.'}, {'ForeName': 'Joon-Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Cheongju University, Cheongju City, Republic of Korea.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000376']
3326,31789060,Correlates of fear of falling and falls efficacy in geriatric patients recovering from hip/pelvic fracture.,"OBJECTIVE


To gain a better understanding about the nature of fear of falling, this study analyzed associations between psychological and physical aspects related to fear of falling and falls efficacy in hip/pelvic fracture patients.
DESIGN


Baseline data of a randomized controlled trial.
SETTING


Geriatric inpatient rehabilitation hospital.
SUBJECTS


In all, 115 geriatric patients with hip/pelvic fracture (mean age: 82.5 years) reporting fear of falling within first week of inpatient rehabilitation.
INTERVENTIONS


None.
MAIN MEASURES


Falls efficacy (Short Falls Efficacy Scale-International; Perceived Ability to Manage Falls), fear of falling (one-item question), fall-related post-traumatic stress symptoms (six items based on  Diagnostic and Statistical Manual of Mental Disorders  (4th ed.;  DSM -IV) criteria), physical performance (Short Physical Performance Battery) and psychological inflexibility (Acceptance and Action Questionnaire-II) were assessed.
RESULTS


Path analyses demonstrated that low falls efficacy (Short Falls Efficacy Scale International) was significantly related to poor physical performance ( β * = -.277,  P  ⩽ .001), but not to psychological inflexibility and fall-related post-traumatic stress symptoms ( P  ⩾ .05.). Fear of falling was directly associated with fall-related post-traumatic stress symptoms ( β *= .270,  P  = .007) and indirectly with psychological inflexibility ( β *= .110,  P  = .022). Low perceived ability to manage falls was significantly related to previous falls ( β * = -.348,  P  ⩽ .001), psychological inflexibility ( β * = -.216,  P  = .022) and female gender ( β * = -.239,  P  ⩽ .01).
CONCLUSION


Falls efficacy and fear of falling constitute distinct constructs. Falls efficacy measured with the Short Falls Efficacy Scale International reflects the appraisal of poor physical performance. Fear of falling measured by the single-item question constitutes a fall-specific psychological construct associated with psychological inflexibility and fall-related post-traumatic stress symptoms.",2020,Fear of falling measured by the single-item question constitutes a fall-specific psychological construct associated with psychological inflexibility and fall-related post-traumatic stress symptoms.,"['geriatric patients recovering from hip/pelvic fracture', '115 geriatric patients with hip/pelvic fracture (mean age: 82.5\u2009years) reporting fear of falling within first week of inpatient rehabilitation', 'Geriatric inpatient rehabilitation hospital', 'hip/pelvic fracture patients']",[],"['Falls efficacy and fear of falling constitute distinct constructs', 'low falls efficacy (Short Falls Efficacy Scale International', 'Falls efficacy', 'fear of falling and falls efficacy', 'Falls efficacy (Short Falls Efficacy Scale-International; Perceived Ability to Manage Falls), fear of falling (one-item question), fall-related post-traumatic stress symptoms (six items based on  Diagnostic and Statistical Manual of Mental Disorders  (4th ed.;  DSM -IV) criteria), physical performance (Short Physical Performance Battery) and psychological inflexibility (Acceptance and Action Questionnaire-II', 'psychological inflexibility', 'Fear of falling', 'psychological inflexibility and fall-related post-traumatic stress symptoms']","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0149531', 'cui_str': 'Pelvic fracture'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517887', 'cui_str': '82.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international (assessment scale)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2607857'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",115.0,0.0102616,Fear of falling measured by the single-item question constitutes a fall-specific psychological construct associated with psychological inflexibility and fall-related post-traumatic stress symptoms.,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eckert', 'Affiliation': 'Agaplesion Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kampe', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Albrecht', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Büchele', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hauer', 'Affiliation': 'Agaplesion Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Schäufele', 'Affiliation': 'Department of Social Work, Mannheim University of Applied Sciences, Mannheim, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany.'}]",Clinical rehabilitation,['10.1177/0269215519891233']
3327,29076963,Mechanical and Metabolic Responses to Traditional and Cluster Set Configurations in the Bench Press Exercise.,"García-Ramos, A, González-Hernández, JM, Baños-Pelegrín, E, Castaño-Zambudio, A, Capelo-Ramírez, F, Boullosa, D, Haff, GG, and Jiménez-Reyes, P. Mechanical and metabolic responses to traditional and cluster set configurations in the bench press exercise. J Strength Cond Res 34(3): 663-670, 2020-This study aimed to compare mechanical and metabolic responses between traditional (TR) and cluster (CL) set configurations in the bench press exercise. In a counterbalanced randomized order, 10 men were tested with the following protocols (sets × repetitions [inter-repetition rest]): TR1: 3 × 10 (0-second), TR2: 6 × 5 (0-second), CL5: 3 × 10 (5-second), CL10: 3 × 10 (10-second), and CL15: 3 × 10 (15-second). The number of repetitions (30), interset rest (5 minutes), and resistance applied (10 repetition maximum) were the same for all set configurations. Movement velocity and blood lactate concentration were used to assess the mechanical and metabolic responses, respectively. The comparison of the first and last set of the training session revealed a significant decrease in movement velocity for TR1 (Effect size [ES]: -0.92), CL10 (ES: -0.85), and CL15 (ES: -1.08) (but not for TR2 [ES: -0.38] and CL5 [ES: -0.37]); while blood lactate concentration was significantly increased for TR1 (ES: 1.11), TR2 (ES: 0.90), and CL5 (ES: 1.12) (but not for CL10 [ES: 0.03] and CL15 [ES: -0.43]). Based on velocity loss, set configurations were ranked as follows: TR1 (-39.3 ± 7.3%) > CL5 (-20.2 ± 14.7%) > CL10 (-12.9 ± 4.9%), TR2 (-10.3 ± 5.3%), and CL15 (-10.0 ± 2.3%). The set configurations were ranked as follows based on the lactate concentration: TR1 (7.9 ± 1.1 mmol·L) > CL5 (5.8 ± 0.9 mmol·L) > TR2 (4.2 ± 0.7 mmol·L) > CL10 (3.5 ± 0.4 mmol·L) and CL15 (3.4 ± 0.7 mmol·L). These results support the use of TR2, CL10, and CL15 for the maintenance of high mechanical outputs, while CL10 and CL15 produce less metabolic stress than TR2.",2020,"; while blood lactate concentration was significantly increased for TR1 (ES: 1.11), TR2 (ES: 0.90), and CL5 (ES: 1.12) (but not for CL10",['10 men were tested with the following protocols (sets × repetitions [inter-repetition rest'],"['J Strength Cond Res XX(X', 'traditional (TR) and cluster (CL) set configurations', 'CL10']","['Movement velocity and blood lactate concentration', 'movement velocity for TR1 (Effect size [ES', 'blood lactate concentration', 'number of repetitions (30), interset rest (5 minutes), and resistance applied (10 repetition maximum']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]",10.0,0.0274248,"; while blood lactate concentration was significantly increased for TR1 (ES: 1.11), TR2 (ES: 0.90), and CL5 (ES: 1.12) (but not for CL10","[{'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'González-Hernández', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Baños-Pelegrín', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Castaño-Zambudio', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Capelo-Ramírez', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Boullosa', 'Affiliation': 'Post-Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'G Gregory', 'Initials': 'GG', 'LastName': 'Haff', 'Affiliation': 'Center for Exercise and Sport Science Research, Edith Cowan University, Joondalup, Australia.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': 'Faculty of Sport, Catholic University of San Antonio, Murcia, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002301']
3328,30657996,"Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen 325 mg.","OBJECTIVES


To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used.
METHODS


This was a multicenter, randomized, double-blind, placebo- and active-controlled multidose study. After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to severe pain (measured on a categorical pain intensity scale [PI-CAT]) were randomized to CL-108, HC/APAP, or placebo. Over the next 24 hours, patients used the PI-CAT to assess pain at regular intervals whereas nausea, vomiting, and other opioid-related side effects were also assessed prospectively. Study medications were taken every four to six hours as needed; supplemental rescue analgesic and antiemetic medications were permitted. Co-primary end points were the incidence of OINV and the time-weighted sum of pain intensity differences over 24 hours (SPID24).
RESULTS


Relative to HC/APAP treatment alone, CL-108 treatment reduced OINV by 64% (P < 0.001). Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001). There were no unexpected or serious adverse events.
CONCLUSIONS


CL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain.",2019,"Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001).","['After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to', 'Moderate to Severe Acute Pain']","['placebo', 'CL-108', 'CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen', 'Placebo', 'CL-108, HC/APAP, or placebo', 'hydrocodone 7.5\u2009mg/acetaminophen 325\u2009mg (HC/APAP']","['Nausea and Vomiting', 'nausea, vomiting, and other opioid-related side effects', 'categorical pain intensity scale [PI-CAT', 'pain intensity', 'incidence of OINV and the time-weighted sum of pain intensity differences', 'serious adverse events', 'severe pain', 'nausea and vomiting (OINV']","[{'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0399551', 'cui_str': 'Impacted third molar tooth (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C1604179', 'cui_str': 'Acetaminophen 325 MG [Acephen]'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C3539175', 'cui_str': 'Other opioids in ATC'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",466.0,0.364,"Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001).","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Zuniga', 'Affiliation': 'Department of Surgery and Division of Oral and Maxillofacial Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Athena S', 'Initials': 'AS', 'LastName': 'Papas', 'Affiliation': 'Department of Diagnostic Sciences, Tufts School of Dental Medicine, Boston, Massachusetts.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Daniels', 'Affiliation': 'Optimal Research, LLC, Austin, Texas.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'PRA Health Sciences, San Diego, California.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Muse', 'Affiliation': 'Jean Brown Research, Inc., Salt Lake City, Utah.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Oreadi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Tufts School of Dental Medicine, Boston, Massachusetts.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Granquist', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lawrence M', 'Initials': 'LM', 'LastName': 'Levin', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joli C', 'Initials': 'JC', 'LastName': 'Chou', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Maibach', 'Affiliation': 'IndigoRDD, LLC, Bethesda, Maryland.'}, {'ForeName': 'Bernard P', 'Initials': 'BP', 'LastName': 'Schachtel', 'Affiliation': 'Olas Pharma, Inc. (wholly owned subsidiary of Charleston Laboratories, Inc.), Jupiter, Florida, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny294']
3329,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3330,32049937,"Weekly Teriparatide Versus Bisphosphonate for Bone Union During 6 Months After Multi-Level Lumbar Interbody Fusion for Osteoporotic Patients: A Multicenter, Prospective, Randomized Study.","STUDY DESIGN


Multicenter, prospective randomized study.
OBJECTIVE


Evaluate the impact of weekly teriparatide (WT) and bone contact (BC) status of grafted bone in patients recovering from multilevel lumbar interbody fusion (M-LIF).
SUMMARY OF BACKGROUND DATA


WT has been reported to significantly improve bone fusion following posterior or transforaminal interbody fusion in osteoporosis patients.
METHODS


Patients older than 50 years and osteoporotic were recruited. We defined the fusion of two or more consecutive intervertebral levels as M-LIF. All patients were instrumented with pedicle, iliac, or S-2 alar iliac screws after transplanting cages and autogenous bone between vertebral bodies. After surgical indication for M-LIF, the subjects were randomly allocated to receive either subcutaneous WT from 1 week to 6 months postoperatively (WT arm, N = 50) or a bisphosphonate (BP; BP arm, N = 54). Blinded radiological evaluations were performed using computed tomography (CT). Evaluation of bone fusion was performed at the intervertebral disc located at the bottom of the fixed range. The degree of bone fusion was calculated as a score from 2 to 6 points, with 2 defined as complete fusion. Bone fusion rate was also compared at 6 months postoperatively based on BC status of the grafted bone on CT immediately after surgery.
RESULTS


Mean bone fusion score at 6 months postoperatively was 3.9 points in the WT group and 4.2 points in the BP group. The bone fusion rate at 6 months postoperatively tended to be higher in the WT group (46.8% vs. 32.7% in the BP group). The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%).
CONCLUSION


In M-LIF, there were no significant differences in bone fusion score between WT- and BP-treated patients. In contrast, BC status immediately postoperatively had a major impact on 6-month bone fusion.
LEVEL OF EVIDENCE


1.",2020,"The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%).
","['Osteoporotic Patients', 'patients recovering from multi-level lumbar interbody fusion (M-LIF', 'All patients were instrumented with pedicle, iliac, or S-2 alar iliac screws after transplanting cages and autogenous bone between vertebral bodies', 'Patients older than 50 years and osteoporotic were recruited']","['teriparatide (WT) and bone contact (BC) status of grafted bone', 'Teriparatide versus Bisphosphonate', 'bisphosphonate', 'subcutaneous WT', 'BC']","['bone fusion rate', '6-month postoperative fusion rate of immediately postoperative of BC+ patients', 'Mean bone fusion score', 'degree of bone fusion', 'bone fusion score', 'Bone fusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C2722359', 'cui_str': 'S-2'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",,0.037528,"The 6-month postoperative fusion rate of immediately postoperative of BC+ patients was significantly higher than that of BC- patients (47.4% vs. 9.5%).
","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yokomichi', 'Affiliation': 'Department of Health Sciences, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Ebata', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Mukaiyama', 'Affiliation': 'Department of Orthopaedic Surgery, North Alps Medical Center Azumi Hospital, Nagano, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ushirozako', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Shugo', 'Initials': 'S', 'LastName': 'Kuraishi', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Ikegami', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Uehara', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takizawa', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Munakata', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Terue', 'Initials': 'T', 'LastName': 'Hatakenaka', 'Affiliation': 'Department of Orthopaedic Surgery, Shinshu University School of Medicine, Nagano, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopaedic Surgery, University of Yamanashi School of Medicine, Yamanashi, Japan.'}]",Spine,['10.1097/BRS.0000000000003426']
3331,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3332,31348053,Two-Week Multimodal Prehabilitation Program Improves Perioperative Functional Capability in Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial.,"BACKGROUND


Patients with lung cancer often experience reduced functional capacity and quality of life after surgery. The current study investigated the impact of a short-term, home-based, multimodal prehabilitation program on perioperative functional capacity in patients undergoing video-assisted thoracoscopic surgery (VATS) lobectomy for nonsmall cell lung cancer (NSCLC).
METHODS


A randomized controlled trial was conducted with 73 patients. Patients in the prehabilitation group (n = 37) received a 2-week multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance. Patients in the control group (n = 36) received the usual clinical care. The assessors were blinded to the patient allocation. The primary outcome was perioperative functional capacity measured as the 6-minute walk distance (6MWD), which was assessed at 1 day before and 30 days after surgery. A linear mixed-effects model was built to analyze the perioperative 6MWD. Other outcomes included lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality.
RESULTS


The median duration of prehabilitation was 15 days. The average 6MWD was 60.9 m higher perioperatively in the prehabilitation group compared to the control group (95% confidence interval [CI], 32.4-89.5; P < .001). There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
CONCLUSIONS


A 2-week, home-based, multimodal prehabilitation program could produce clinically relevant improvements in perioperative functional capacity in patients undergoing VATS lobectomy for lung cancer.",2020,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","['Patients in the prehabilitation group (n = 37', 'patients undergoing', '73 patients', 'Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer', 'patients undergoing VATS lobectomy for lung cancer', 'nonsmall cell lung cancer (NSCLC', 'Patients with lung cancer']","['short-term, home-based, multimodal prehabilitation program', 'usual clinical care', 'multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance', 'video-assisted thoracoscopic surgery (VATS) lobectomy']","['median duration of prehabilitation', 'Perioperative Functional Capability', 'lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity', 'perioperative functional capacity measured as the 6-minute walk distance (6MWD', 'functional capacity and quality of life', 'perioperative functional capacity', 'lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality', 'average 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4520228', 'cui_str': 'VATS (video-assisted thoracoscopic surgery) lobectomy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.141417,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","[{'ForeName': 'Zijia', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the *Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China †Central Research Laboratory, Peking Union Medical College Hospital, Beijing, China Departments of ‡Thoracic Surgery §Enteral and Parenteral Nutrition, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': ''}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yushang', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Naixin', 'Initials': 'N', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Shanqing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004342']
3333,32043304,Enteral hydration in high-flow therapy for infants with bronchiolitis: Secondary analysis of a randomised trial.,"AIM


Nasal high-flow oxygen therapy is increasingly used in infants for supportive respiratory therapy in bronchiolitis. It is unclear whether enteral hydration is safe in children receiving high-flow.
METHODS


We performed a planned secondary analysis of a multi-centre, randomised controlled trial of infants aged <12 months with bronchiolitis and an oxygen requirement. Children were assigned to treatment with either high-flow or standard-oxygen therapy with optional rescue high-flow. We assessed adverse events based on how children on high-flow were hydrated: intravenously (IV), via bolus or continuous nasogastric tube (NGT) or orally.
RESULTS


A total of 505 patients on high-flow via primary study assignment (n = 408), primary treatment (n = 10) or as rescue therapy (n = 87) were assessed. While on high flow, 15 of 505 (3.0%) received only IV fluids, 360 (71.3%) received only enteral fluids and 93 (18.4%) received both IV and enteral fluids. The route was unknown in 37 (7.3%). Of the 453 high-flow infants hydrated enterally patients could receive one or more methods of hydration; 80 (15.8%) received NGT bolus, 217 (43.0%) NGT continuous, 118 (23.4%) both bolus and continuous, 32 (6.3%) received only oral hydration and 171 (33.9%) a mix of NGT and oral hydration. None of the patients receiving oral or NGT hydration on high-flow sustained pulmonary aspiration (0%; 95% confidence interval N/A); one patient had a pneumothorax (0.2%; 95% confidence interval 0.0-0.7%).
CONCLUSIONS


The vast majority of children with hypoxic respiratory failure in bronchiolitis can be safely hydrated enterally during the period when they receive high-flow.",2020,"None of the patients receiving oral or NGT hydration on high-flow sustained pulmonary aspiration (0%; 95% confidence interval N/A); one patient had a pneumothorax (0.2%; 95% confidence interval 0.0-0.7%).
","['children receiving high-flow', 'infants with bronchiolitis', 'infants for supportive respiratory therapy in bronchiolitis', 'children with hypoxic respiratory failure in bronchiolitis', 'infants aged <12\u2009months with bronchiolitis and an oxygen requirement', '505 patients on high-flow via primary study assignment (n = 408), primary treatment (n = 10) or as rescue therapy (n = 87) were assessed']","['Enteral hydration', 'Nasal high-flow oxygen therapy', 'NGT and oral hydration', 'NGT', 'continuous nasogastric tube (NGT) or orally', 'high-flow or standard-oxygen therapy with optional rescue high-flow']","['pneumothorax', 'high-flow sustained pulmonary aspiration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0035239', 'cui_str': 'Respiratory Therapy'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube, device (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0700198', 'cui_str': 'Pulmonary aspiration (finding)'}]",87.0,0.338205,"None of the patients receiving oral or NGT hydration on high-flow sustained pulmonary aspiration (0%; 95% confidence interval N/A); one patient had a pneumothorax (0.2%; 95% confidence interval 0.0-0.7%).
","[{'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': ""Pediatric Critical Care Research Group, Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Dalziel', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Furyk', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Victoria, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': ""Pediatric Critical Care Research Group, Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': ""Pediatric Critical Care Research Group, Queensland Children's Hospital and The University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of paediatrics and child health,['10.1111/jpc.14799']
3334,32041812,Impact of an education and multilevel social comparison-based intervention bundle on use of routine blood tests in hospitalised patients at an academic tertiary care hospital: a controlled pre-intervention post-intervention study.,"BACKGROUND


Repetitive inpatient laboratory testing contributes to waste in healthcare. We evaluated an intervention bundle combining education and multilevel social comparison feedback to safely reduce repetitive use of inpatient routine laboratory tests.
METHODS


This non-randomised controlled pre-intervention post-intervention study was conducted in four adult hospitals from October 2016 to March 2018. In the medical teaching unit (MTU) of the intervention site, learners received education and aggregate social comparison feedback and attending internists received individual comparison feedback on routine laboratory test utilisation. MTUs of the remaining three sites served as control units. Number and cost of routine laboratory tests ordered per patient-day before and after the intervention was compared with the control units, adjusting for patient factors. Safety endpoints included number of critically abnormal laboratory test results, number of stat laboratory test orders, patient length of stay, transfer rate to the ICU, and 30-day readmission and mortality.
RESULTS


A total of 14 000 patients were included. Pre-intervention and post-intervention groups were similar in age, sex, Charlson Comorbidity Index and length of stay. From the pre-intervention period to the post-intervention period, significantly fewer routine laboratory tests were ordered at the intervention MTU (incidence rate ratio=0.89; 95% CI 0.79 to 1.00; p=0.048) with associated costs savings of $C68 877 (p=0.020) as compared with the control sites. The variability in the ordering pattern of internists at the intervention site also decreased post-intervention. No worsening was noted in the safety endpoints between the pre-intervention and post-intervention period at the intervention unit compared with the controls.
CONCLUSIONS


Combination of education and multilevel social comparison feedback significantly and  safely  led to cost savings through reduced use of routine laboratory tests in hospitalised patients.",2020,"No worsening was noted in the safety endpoints between the pre-intervention and post-intervention period at the intervention unit compared with the controls.
","['A total of 14\u2009000 patients were included', 'hospitalised patients at an academic tertiary care hospital', 'hospitalised patients', 'four adult hospitals from October 2016 to March 2018']","['education and aggregate social comparison feedback and attending internists received individual comparison feedback', 'education and multilevel social comparison-based intervention bundle']","['costs savings', 'Number and cost of routine laboratory tests', 'safety endpoints', 'number of critically abnormal laboratory test results, number of stat laboratory test orders, patient length of stay, transfer rate to the ICU, and 30-day readmission and mortality', 'routine laboratory tests']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0278602', 'cui_str': 'Internal medicine specialist (occupation)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test result'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",14000.0,0.0222036,"No worsening was noted in the safety endpoints between the pre-intervention and post-intervention period at the intervention unit compared with the controls.
","[{'ForeName': 'Anshula', 'Initials': 'A', 'LastName': 'Ambasta', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada aambasta@ucalgary.ca.'}, {'ForeName': 'Irene Wai Yan', 'Initials': 'IWY', 'LastName': 'Ma', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Woo', 'Affiliation': 'Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Lonergan', 'Affiliation': 'Analysis, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mackay', 'Affiliation': 'Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Williamson', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010118']
3335,32035945,"Efficacy and safety of microneedling and oral tranexamic acid in the treatment of facial melasma in women: An open, evaluator-blinded, randomized clinical trial.",,2020,,['facial melasma in women'],['microneedling and oral tranexamic acid'],['Efficacy and safety'],"[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.2716,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cassiano', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil. Electronic address: danielpcassiano@uol.com.br.'}, {'ForeName': 'Ana Cláudia Cavalcante', 'Initials': 'ACC', 'LastName': 'Esposito', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Karime', 'Initials': 'K', 'LastName': 'Hassun', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ediléia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mariana Modesto D A', 'Initials': 'MMDA', 'LastName': 'Lima', 'Affiliation': 'Santa Casa de Misericórdia, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Emerson V A', 'Initials': 'EVA', 'LastName': 'Lima', 'Affiliation': 'Santa Casa de Misericórdia, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Luciane Donida Bartoli', 'Initials': 'LDB', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.002']
3336,32040398,The Influence of the New US Nutrition Facts Label on Consumer Perceptions and Understanding of Added Sugars: A Randomized Controlled Experiment.,"BACKGROUND AND OBJECTIVES


This study assessed the effects of the new Nutrition Facts label (NFL) compared with the current NFL on consumer purchase intentions and understanding of added sugars, and differences by educational attainment.
DESIGN


Randomized controlled online experiment.
PARTICIPANTS/SETTING


Final study sample of 1,156 US adults, oversampling participants with low education.
INTERVENTION


All participants were exposed to a control condition (images of bread, 100% juice, yogurt, and canned fruit with no NFL) and then randomized to one of two label conditions: the current NFL with information on total sugars only or the new NFL with information on added sugars. Participants responded to the same set of questions in the control and the label conditions while viewing products that displayed one of the two NFLs.
MAIN OUTCOME MEASURES


Differences in scores averaged across all products for understanding of added sugars (proportion of correctly answered multiple-choice questions) and purchase intentions (5-point Likert scale ranging from extremely likely to extremely unlikely).
STATISTICAL ANALYSES PERFORMED


One-way analysis of variance was used to test for differences between NFLs.
RESULTS


Compared with the current NFL, participants in the new NFL arm had better understanding of added sugars content (P<0.01). Although no significant differences were seen for purchase intentions overall, there were differences for individual products. Participants in the new NFL arm were more likely to purchase the juice (P<0.01) and less likely to buy the bread (P<0.01) compared with participants in the current NFL arm. There were no differences by educational attainment.
CONCLUSIONS


Participants were better able to locate and extract added sugars information when viewing the new NFL compared with the current NFL. The new NFL may increase intent to purchase products low in added sugars but high in refined carbohydrates-an unintended consequence that warrants further study.",2020,Participants in the new NFL arm were more likely to purchase the juice (P<0.01) and less likely to buy the bread (P<0.01) compared with participants in the current NFL arm.,"['Final study sample of 1,156 US adults, oversampling participants with low education']","['new Nutrition Facts label (NFL', 'current NFL with information on total sugars only or the new NFL with information on added sugars', 'current NFL', 'control condition (images of bread, 100% juice, yogurt, and canned fruit with no NFL']",[],"[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0453312', 'cui_str': 'Tinned fruit (substance)'}]",[],1156.0,0.0622381,Participants in the new NFL arm were more likely to purchase the juice (P<0.01) and less likely to buy the bread (P<0.01) compared with participants in the current NFL arm.,"[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Khandpur', 'Affiliation': ''}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': ''}, {'ForeName': 'Alyssa J', 'Initials': 'AJ', 'LastName': 'Moran', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.10.008']
3337,31725060,Long-Term Outcomes of HIV-Infected Women Receiving Antiretroviral Therapy After Transferring Out of an Integrated Maternal and Child Health Service in South Africa.,"BACKGROUND


Integrated maternal and child health (MCH) services improve women's postpartum antiretroviral therapy (ART) outcomes during breastfeeding; however, long-term outcomes after transfer to general ART services remain unknown.
METHODS


The MCH-ART trial demonstrated that maternal retention and viral suppression at 12-months postpartum were improved significantly among women randomized to integrated MCH services continued in the antenatal clinic through cessation of breastfeeding (MCH-ART arm) compared with immediate transfer to general ART services postpartum (standard of care). We reviewed electronic health records for all women who participated in the MCH-ART trial to ascertain retention and gaps in care and invited all women for a study visit 36- to 60-months postpartum including viral load testing.
RESULTS


Of 471 women in MCH-ART, 450 (96%) contributed electronic health record data and 353 (75%) completed the study visit (median 44-month postpartum). At this time, outcomes were identical in both trial arms: 67% retained in care (P = 0.994) and 56% with viral loads <50 copies/mL (P = 0.751). Experiencing a gap in care after delivery was delayed in the MCH-ART arm with 17%, 36%, and 45% of women experienced a gap in care by 12-, 24-, and 36-months postpartum compared with 35%, 48%, and 57% in the standard of care arm, respectively.
CONCLUSIONS


The benefits of integrated maternal HIV and child health care did not persist after transfer to general ART services. The transfer of women postpartum to routine adult care is a critical period requiring interventions to support continuity of HIV care.",2020,"At this time, outcomes were identical in both trial arms: 67% retained in care (p=0.994); 56% with viral loads <50 copies/mL (p=0.751).","['HIV-infected women receiving antiretroviral therapy after transferring out of an integrated maternal and child health service in South Africa', 'all women who participated in the MCH-ART trial to ascertain retention and gaps in care and invited all women for a study visit 36-60 months postpartum including viral load testing', '471 women in MCH-ART, 450 (96%) contributed electronic health record data and 353 (75%) completed the study visit (median 44 months postpartum']",['Integrated maternal and child health (MCH) services'],['maternal retention and viral suppression'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0913047', 'cui_str': '(HP)MCH'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]",471.0,0.196827,"At this time, outcomes were identical in both trial arms: 67% retained in care (p=0.994); 56% with viral loads <50 copies/mL (p=0.751).","[{'ForeName': 'Tamsin K', 'Initials': 'TK', 'LastName': 'Phillips', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Pheposadi', 'Initials': 'P', 'LastName': 'Mogoba', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brittain', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Gomba', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zerbe', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University, New York, NY.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002236']
3338,31352497,Improved mediolateral load distribution without adverse laxity pattern in robot-assisted knee arthroplasty compared to a standard manual measured resection technique.,"PURPOSE


Robot-assisted total knee arthroplasty (rTKA) remains in its infancy, is expensive but offers the promise of improved kinematic performance through precise bone cuts, with minimal soft tissue disruption, based on pre-resection soft tissue behaviour. This cadaveric study examined load transfer, soft tissue performance and radiographic indices for conventional (sTKA) versus rTKA. The null hypothesis was there would be no difference between the two modes of implantation.
METHODS


Whole (ten) cadaveric limbs were randomised to receive either robotic (rTKA, N = 5) or conventional measured resection (sTKA, N = 5) knee arthroplasty. Laxity patterns were established using validated fixed sensors (Verasense) with manual maximum displacement for six degrees of freedom. Tibiofemoral load and contact points were determined dynamically using remote sensor technology for medial and lateral compartments through a functional arc of motion (0-110 degrees of motion). Final component position was assessed using pre- and post-implantation CT.
RESULTS


No significant intergroup differences for laxity were found (n.s.). The rTKA group exhibited consistently balanced mediolateral load throughout the full arc with significantly reduced overall total load across the joint (for distinct points of measurement, p < 0.05). Despite using flexion-extension and mediolateral gap balancing with measured resection, the sTKA group failed to achieve balance in at least three points of the flexion arc. Post-operative CT confirmed satisfactory component alignment with no significant differences for positioning between the two groups.
CONCLUSION


This work found improved load sharing for rTKA when compared to conventional surgery for same donor knees. Laxity and CT determined final component positioning was not significantly different. The work supports the contention that robot-assisted TKA delivers improved tibiofemoral load sharing in time zero studies under defined conditions but such offers the promise of improved clinical performance and reduced implant wear.",2020,Laxity patterns were established using validated fixed sensors (Verasense) with manual maximum displacement for six degrees of freedom.,['Whole (ten) cadaveric limbs'],"['robotic (rTKA, N\u2009=\u20095) or conventional measured resection (sTKA, N\u2009=\u20095) knee arthroplasty', 'standard manual measured resection technique', 'conventional (sTKA) versus rTKA', 'robot-assisted knee arthroplasty', 'Robot-assisted total knee arthroplasty (rTKA', 'robot-assisted TKA', 'rTKA']","['overall total load', 'Laxity and CT determined final component positioning', 'balanced mediolateral load', 'laxity']","[{'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}]",,0.0294277,Laxity patterns were established using validated fixed sensors (Verasense) with manual maximum displacement for six degrees of freedom.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Manning', 'Affiliation': 'Newcastle Surgical Training Centre Research Unit Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Ghosh', 'Affiliation': 'Newcastle Surgical Training Centre Research Unit Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wilson', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University International Centre for Life, Central Parkway, Newcastle upon Tyne, NE1 3BZ, UK.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Hide', 'Affiliation': 'Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Longstaff', 'Affiliation': 'University Hospital of North Durham, Durham, DH1 5TW, England, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Deehan', 'Affiliation': 'Newcastle Surgical Training Centre Research Unit Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK. deehan1@hotmail.co.uk.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05631-y']
3339,30560426,"The Effects of Synbiotic Supplementation on Metabolic Status in Diabetic Patients Undergoing Hemodialysis: a Randomized, Double-Blinded, Placebo-Controlled Trial.","This study was conducted to evaluate the effects of synbiotic supplementation on metabolic profiles in diabetic patients undergoing hemodialysis (HD). This randomized, double-blinded, placebo-controlled clinical trial was performed in 60 diabetic HD patients. Participants were randomly assigned into two groups to receive either synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2 × 10 9  CFU/g each), plus 0.8 g/day of inulin (n = 30) or placebo (n = 30) for 12 weeks. Synbiotic supplementation significantly decreased fasting plasma glucose (β - 13.56 mg/dL; 95% CI, - 23.82, - 3.30; P = 0.01), insulin levels (β - 5.49 μIU/mL; 95% CI, - 6.92, - 4.05; P < 0.001), and insulin resistance (β - 2.25; 95% CI, - 3.02, - 1.48; P < 0.001), while increased the quantitative insulin sensitivity check index (β 0.02; 95% CI, 0.01, 0.02; P < 0.001) compared with the placebo. Additionally, synbiotic intake resulted in a significant reduction in high-sensitivity C-reactive protein (β - 2930.48 ng/mL; 95% CI, - 3741.15, - 2119.80; P < 0.001) and malondialdehyde levels (β - 0.60 μmol/L; 95% CI, - 0.99, - 0.20; P = 0.003). Moreover, we found a significant increase in total antioxidant capacity (β 142.99 mmol/L; 95% CI, 61.72, 224.25; P = 0.001) and total glutathione levels (β 131.11 μmol/L; 95% CI, 89.35, 172.87; P < 0.001) in the synbiotic group compared with the placebo group. Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT2017090133941N17). http://www.irct.ir: IRCT2017090133941N17.",2019,"Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD.","['60 diabetic HD patients', 'diabetic patients undergoing hemodialysis (HD', 'Diabetic Patients Undergoing Hemodialysis', 'diabetic patients under HD']","['placebo', 'Synbiotic supplementation', 'Placebo', 'Synbiotic Supplementation', 'synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2', 'synbiotic supplementation']","['total glutathione levels', 'quantitative insulin sensitivity check index', 'insulin resistance', 'high-sensitivity C-reactive protein', 'malondialdehyde levels', 'Metabolic Status', 'metabolic profiles', 'insulin levels', 'total antioxidant capacity', 'glycemic control, biomarkers of inflammation, and oxidative stress', 'fasting plasma glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",60.0,0.756403,"Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motamedzadeh', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Zarrati Mojarrad', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Faculty member of Science department, science faculty, Islamic Azad University Tehran Central Branch, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9499-3']
3340,32029126,Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.,"BACKGROUND


In patients with non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary pathology may range from structurally normal vessels to severe coronary artery disease.
OBJECTIVES


The purpose of this study was to test if coronary computed tomography angiography (CTA) may be used to exclude coronary artery stenosis ≥50% in patients with NSTEACS.
METHODS


The VERDICT (Very Early Versus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes) trial (NCT02061891) evaluated the outcome of patients with confirmed NSTEACS randomized 1:1 to very early (within 12 h) or standard (48 to 72 h) invasive coronary angiography (ICA). As an observational component of the trial, a clinically blinded coronary CTA was conducted prior to ICA in both groups. The primary endpoint was the ability of coronary CTA to rule out coronary artery stenosis (≥50% stenosis) in the entire population, expressed as the negative predictive value (NPV), using ICA as the reference standard.
RESULTS


Coronary CTA was conducted in 1,023 patients-very early, 2.5 h (interquartile range [IQR]: 1.8 to 4.2 h), n = 583; and standard, 59.9 h (IQR: 38.9 to 86.7 h); n = 440 after the diagnosis of NSTEACS was made. A coronary stenosis ≥50% was found by coronary CTA in 68.9% and by ICA in 67.4% of the patients. Per-patient NPV of coronary CTA was 90.9% (95% confidence interval [CI]: 86.8% to 94.1%) and the positive predictive value, sensitivity, and specificity were 87.9% (95% CI: 85.3% to 90.1%), 96.5% (95% CI: 94.9% to 97.8%) and 72.4% (95% CI: 67.2% to 77.1%), respectively. NPV was not influenced by patient characteristics or clinical risk profile and was similar in the very early and the standard strategy group.
CONCLUSIONS


Coronary CTA has a high diagnostic accuracy to rule out clinically significant coronary artery disease in patients with NSTEACS.",2020,"NPV was not influenced by patient characteristics or clinical risk profile and was similar in the very early and the standard strategy group.
","['patients with non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary pathology may range from structurally normal vessels to severe coronary artery disease', 'patients with NSTEACS', '1,023 patients-very early, 2.5\xa0h (interquartile range [IQR]: 1.8 to 4.2 h), n\xa0=\xa0583; and standard, 59.9\xa0h (IQR: 38.9 to 86.7 h); n\xa0', 'Patients With Non-ST-Segment Elevation Acute Coronary\xa0Syndrome', 'Patients With Acute Coronary Syndromes']","['coronary computed tomography angiography (CTA', 'invasive coronary angiography (ICA', 'Coronary CT Angiography', 'VERDICT ', 'Very Early Versus Deferred Invasive Evaluation Using Computerized Tomography']","['ability of coronary CTA to rule out coronary artery stenosis', 'positive predictive value, sensitivity, and specificity', 'coronary CTA', 'negative predictive value (NPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",1023.0,0.0601611,"NPV was not influenced by patient characteristics or clinical risk profile and was similar in the very early and the standard strategy group.
","[{'ForeName': 'Jesper J', 'Initials': 'JJ', 'LastName': 'Linde', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per E', 'Initials': 'PE', 'LastName': 'Sigvardsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bech', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Heitmann', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Olav W', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Kühl', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Ilan E', 'Initials': 'IE', 'LastName': 'Raymond', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ole P', 'Initials': 'OP', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida H', 'Initials': 'IH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria H D', 'Initials': 'MHD', 'LastName': 'Vall-Lamora', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kragelund', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'de Knegt', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Hove', 'Affiliation': 'Department of Cardiology, Hvidovre and Amager Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tem', 'Initials': 'T', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Hvidovre and Amager Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gitte G', 'Initials': 'GG', 'LastName': 'Fornitz', 'Affiliation': 'Department of Cardiology, Hvidovre and Amager Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Steffensen', 'Affiliation': 'Department of Cardiology, Hillerød Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Jurlander', 'Affiliation': 'Department of Cardiology, Hillerød Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jawdat', 'Initials': 'J', 'LastName': 'Abdulla', 'Affiliation': 'Department of Cardiology, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Lyngbæk', 'Affiliation': 'Department of Cardiology, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Elming', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Susette K', 'Initials': 'SK', 'LastName': 'Therkelsen', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Kløvgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lia Evi', 'Initials': 'LE', 'LastName': 'Bang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter Riis', 'Initials': 'PR', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Galatius', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frants', 'Initials': 'F', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Abildgaard', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clemmensen', 'Affiliation': 'Department of General and Interventional Cardiology, University Heart Center Hamburg, University Clinic Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Saunamäki', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Gislason', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars V', 'Initials': 'LV', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Kofoed', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: kkofoed@dadlnet.dk.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.12.012']
3341,32030734,The impact of fluid optimisation before induction of anaesthesia on hypotension after induction.,"Intra-operative hypotension is a known predictor of adverse events and poor outcomes following major surgery. Hypotension often occurs on induction of anaesthesia, typically attributed to hypovolaemia and the haemodynamic effects of anaesthetic agents. We assessed the efficacy of fluid optimisation for reducing the incidence of hypotension on induction of anaesthesia. This prospective trial enrolled 283 patients undergoing radical cystectomy and randomly allocated them to goal-directed fluid therapy (n = 142) or standard fluid therapy (n = 141). Goal-directed fluid therapy patients received fluid optimisation based on stroke volume response to passive leg raise before induction; those with positive passive leg raise received intravenous crystalloid fluid boluses until stroke volume was optimised. Baseline mean arterial pressure was measured on the morning of surgery and on arriving in the operating theatre. This post-hoc analysis defined haemodynamic instability as either a > 30% relative drop in mean arterial pressure compared with baseline or absolute mean arterial pressure < 55 mmHg, within 15 min of induction. Forty-two (30%) goal-directed fluid therapy patients underwent fluid optimisation after finding an intravascular fluid deficit via passive leg raise testing; 106 (75%) goal-directed fluid therapy and 112 (79%) standard fluid therapy patients met criteria for haemodynamic instability. There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (p = 0.21, p = 0.89, respectively); however, the difference in the incidence of haemodynamic instability was significant using the operating theatre baseline mean arterial pressure (p = 0.004). We conclude that fluid optimisation before induction of general anaesthesia did not significantly impact haemodynamic instability.",2020,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"['283 patients undergoing', 'patients met criteria for haemodynamic instability']","['goal-directed fluid therapy (n\xa0=\xa0142) or standard fluid therapy', 'radical cystectomy', 'standard fluid therapy']","['haemodynamic instability', 'Baseline mean arterial pressure', 'operating theatre baseline mean arterial pressure', 'mean arterial pressure']","[{'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}]",283.0,0.125273,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seier', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}]",Anaesthesia,['10.1111/anae.14984']
3342,32028455,Footwear and Cadence Affect Gait Variability in Runners with Patellofemoral Pain.,"PURPOSE


To examine the effects of increased cadence and minimalist footwear on lower-limb variability in runners with patellofemoral pain (PFP).
METHODS


Fifteen (12 female, 3 male) runners with PFP ran on an instrumented treadmill with three-dimensional motion capture in three randomly ordered conditions: (i) standard shoe at preferred cadence, (ii) standard shoe +10% cadence, and (iii) minimalist shoe at preferred cadence. Vector coding was used to calculate coordination variability between strides for select lower-limb joint couplings. Approximate entropy was calculated to assess continuous variability for segment kinematic and kinetic data and compared between conditions using repeated-measures ANOVA. One-dimensional statistical parametric mapping repeated-measures ANOVA was performed on the coordination variability data. Cohen's d effect size was calculated for all comparisons.
RESULTS


Larger approximate entropy values (i.e., greater variability) were observed for the standard shoe +10% cadence versus the standard shoe at preferred cadence for hip flexion/extension (P < 0.001; d = 1.12), hip adduction/abduction (P < 0.001; d = 0.99) and ankle dorsiflexion/plantarflexion (P < 0.001; d = 1.37) kinematics, and knee flexion/extension moments (P < 0.001; d = 0.93). Greater variability was also observed in the minimalist shoe versus the standard shoe at preferred cadence for hip internal/external rotation moments (P < 0.001; d = 0.76), knee adduction/abduction moments (P < 0.001; d = 0.51), and knee internal/external rotation moments (P < 0.001; d = 1.02). One-dimensional statistical parametric mapping repeated-measures ANOVA revealed no significant differences in coordination variability between running conditions.
CONCLUSIONS


Greater hip and knee kinematic and kinetic variability observed with either increased cadence or minimalist footwear may be beneficial for those with PFP.",2020,"RESULTS


Larger ApEn values (i.e. greater variability) were observed for the standard shoe +10% cadence versus the standard shoe at preferred cadence for hip flexion/extension (p < 0.001; d = 1.12), hip adduction/abduction (p < 0.001; d = 0.99) and ankle dorsiflexion/plantarflexion (p < 0.001; d = 1.37) kinematics, and knee flexion/extension moments (p < 0.001; d = 0.93).","['Runners with Patellofemoral Pain', 'runners with patellofemoral pain (PFP', 'Fifteen (12 female, 3 male) runners with PFP ran on an']",['instrumented treadmill with 3-dimensional motion capture in three randomly ordered conditions: (i) standard shoe at preferred cadence; (ii) standard shoe +10% cadence; and (iii) minimalist shoe at preferred cadence'],"['ankle dorsiflexion/plantarflexion', 'knee adduction/abduction moments', 'coordination variability', 'hip adduction/abduction', 'Gait Variability', 'knee internal/external rotation moments', 'knee flexion/extension moments', 'Greater variability', 'Greater hip and knee kinematic and kinetic variability']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0442222', 'cui_str': 'Internal/external rotation (qualifier value)'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",,0.0382908,"RESULTS


Larger ApEn values (i.e. greater variability) were observed for the standard shoe +10% cadence versus the standard shoe at preferred cadence for hip flexion/extension (p < 0.001; d = 1.12), hip adduction/abduction (p < 0.001; d = 0.99) and ankle dorsiflexion/plantarflexion (p < 0.001; d = 1.37) kinematics, and knee flexion/extension moments (p < 0.001; d = 0.93).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bonacci', 'Affiliation': 'Centre for Sports Research, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, AUSTRALIA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Fox', 'Affiliation': 'Centre for Sports Research, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, AUSTRALIA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, AUSTRALIA.'}, {'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Fuller', 'Affiliation': 'Faculty of Medicine and Health Science, Macquarie University, AUSTRALIA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences, Physiotherapy, University of Queensland, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002267']
3343,32008990,Comparison of Different Kinesio Taping Techniques After Third Molar Surgery.,"PURPOSE


Elastic therapeutic taping method has been shown to reduce pain and edema after surgery. The purpose of the present study was to compare the effects of 2 different Kinesio taping (KT) techniques on swelling, pain, and trismus after third molar surgery.
PATIENTS AND METHODS


The study was designed as a split-mouth, single-blinded, and controlled randomized clinical trial. Patients undergoing lower impacted third molar extraction at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, were included in the present study. Group I included 30 patients and was used to compare the classic KT technique (technique A) and the new KT technique (technique B). Group II included 15 patients and was used to compare the classic KT technique (technique A) and no KT (No-KT [control]). Group III included 15 patients and was used to compare the new KT technique (technique B) and No-KT (control). Swelling was assessed using the 3dMD Face System (3dMD, Atlanta, GA). The maximum interincisal distance was recorded using a digital caliper preoperatively (T0) and at postoperative days 2 (T1) and 7 (T2). The visual analog scale for pain scores were recorded postoperatively at 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours, and 1, 2, 3, 4, 5, 6, and 7 days. The effects of operative time, patient age, and patient gender were also evaluated.
RESULTS


The data from 60 patients (27 men and 33 women) with a mean age of 22.28 years (range, 18 to 31 years) were analyzed in the present study. The amount of swelling and the interincisal distance were less with technique B than with technique A and no KT (control group).
CONCLUSIONS


KT is a useful method for reducing postoperative morbidity after impacted third molar extraction. In particular, the application of KT using the new technique described in the present study could be more effective than the classic methods.",2020,"The amount of swelling and the interincisal distance were less with technique B than with technique A and no KT (control group).
","['Patients undergoing lower impacted third molar extraction at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, were included in the present study', '60 patients (27 men and 33 women) with a mean age of 22.28\xa0years (range, 18 to 31\xa0years']","['Kinesio Taping Techniques', 'classic KT technique (technique A) and the new KT technique (technique B', 'new KT technique (technique B) and No-KT (control', 'classic KT technique (technique A) and no KT (No-KT [control', 'Kinesio taping (KT) techniques']","['pain and edema', 'amount of swelling and the interincisal distance', 'visual analog scale for pain scores', 'maximum interincisal distance', '3dMD Face System (3dMD, Atlanta, GA', 'swelling, pain, and trismus', 'postoperative morbidity', 'Swelling']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}]",60.0,0.0384293,"The amount of swelling and the interincisal distance were less with technique B than with technique A and no KT (control group).
","[{'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Gözlüklü', 'Affiliation': 'Private Practice, Dental Clinic, İzmir, Turkey. Electronic address: ozgurgozluklu@hotmail.com.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ulu', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, Aydınlıkevler, Turkey.'}, {'ForeName': 'Hilal Öztürk', 'Initials': 'HÖ', 'LastName': 'Gözlüklü', 'Affiliation': 'Physiotherapist and Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Manisa Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Nergiz', 'Initials': 'N', 'LastName': 'Yilmaz', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, İzmir Katip Çelebi University, Aydınlıkevler, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.12.026']
3344,32038101,Efficacy and Safety of 1% Atropine on Retardation of Moderate Myopia Progression in Chinese School Children.,"Background:  To evaluate the long-term efficacy and safety of topical 1% atropine for retarding moderate myopia.  Methods:  A randomized, controlled study evaluating atropine and placebo in 660 Chinese children. Patients received drops q1month for 24 months, then q2month for 12 months, followed by no drops for 12 months. Spherical equivalent, axial length, intraocular pressure and atropine-related side effects were examined at 6, 12, 24, 36 and 48 months for all children.  Results:  Spherical equivalent, myopic progression, axial length augmentation, and progression rate were significantly reduced in the atropine group than those in the placebo group (all P<0.05), indicating that 1% atropine effectively retarded myopia. Moreover, myopic rebound and adverse effects of 1% atropine were eliminated by gradual withdrawal and elimination of 1% atropine. Furthermore, pupil size, near visual acuity, and amplitude of accommodation returned to pretreatment levels after withdrawal of atropine.  Conclusion:  Topical 1% atropine periodically and alternatively in phase I with gradual reduction in phase II and final withdrawal in phase III may effectively improve atropine efficacy, retard moderate myopia, reduce atropine side effects, minimize myopic rebound, and increase compliance of children simultaneously.",2020,"Furthermore, pupil size, near visual acuity, and amplitude of accommodation returned to pretreatment levels after withdrawal of atropine.  ","['Chinese School Children', '660 Chinese children']","['topical 1% atropine', 'atropine and placebo', 'placebo', 'Topical', 'atropine', 'Atropine']","['atropine efficacy, retard moderate myopia', 'Efficacy and Safety', 'Spherical equivalent, axial length, intraocular pressure and atropine-related side effects', 'Spherical equivalent, myopic progression, axial length augmentation, and progression rate', 'retarded myopia', 'myopic rebound and adverse effects', 'Furthermore, pupil size, near visual acuity, and amplitude of accommodation']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0521111', 'cui_str': 'Retarded (slowed) (contextual qualifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}]",660.0,0.228446,"Furthermore, pupil size, near visual acuity, and amplitude of accommodation returned to pretreatment levels after withdrawal of atropine.  ","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Yunnan Province (Fourth Affiliated Hospital of Kunming Medical University); Yunnan Eye Institute; Key Laboratory of Yunnan Province for the Prevention and Treatment of ophthalmology (2017DG008); Provincial Innovation Team for Cataract and Ocular Fundus Disease (2017HC010); Expert Workstation of Yao Ke (2017IC064), Kunming 650021, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Yunnan Province (Fourth Affiliated Hospital of Kunming Medical University); Yunnan Eye Institute; Key Laboratory of Yunnan Province for the Prevention and Treatment of ophthalmology (2017DG008); Provincial Innovation Team for Cataract and Ocular Fundus Disease (2017HC010); Expert Workstation of Yao Ke (2017IC064), Kunming 650021, China.""}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Yunnan Province (Fourth Affiliated Hospital of Kunming Medical University); Yunnan Eye Institute; Key Laboratory of Yunnan Province for the Prevention and Treatment of ophthalmology (2017DG008); Provincial Innovation Team for Cataract and Ocular Fundus Disease (2017HC010); Expert Workstation of Yao Ke (2017IC064), Kunming 650021, China.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Tighe', 'Affiliation': 'Tissue Tech, Inc., Ocular Surface Center, and Ocular Surface Research & Education Foundation, Miami, FL, 33126 USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Yunnan Province (Fourth Affiliated Hospital of Kunming Medical University); Yunnan Eye Institute; Key Laboratory of Yunnan Province for the Prevention and Treatment of ophthalmology (2017DG008); Provincial Innovation Team for Cataract and Ocular Fundus Disease (2017HC010); Expert Workstation of Yao Ke (2017IC064), Kunming 650021, China.""}, {'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Yunnan Province (Fourth Affiliated Hospital of Kunming Medical University); Yunnan Eye Institute; Key Laboratory of Yunnan Province for the Prevention and Treatment of ophthalmology (2017DG008); Provincial Innovation Team for Cataract and Ocular Fundus Disease (2017HC010); Expert Workstation of Yao Ke (2017IC064), Kunming 650021, China.""}, {'ForeName': 'Jieying', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Yunnan Province (Fourth Affiliated Hospital of Kunming Medical University); Yunnan Eye Institute; Key Laboratory of Yunnan Province for the Prevention and Treatment of ophthalmology (2017DG008); Provincial Innovation Team for Cataract and Ocular Fundus Disease (2017HC010); Expert Workstation of Yao Ke (2017IC064), Kunming 650021, China.""}, {'ForeName': 'Yingting', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Tissue Tech, Inc., Ocular Surface Center, and Ocular Surface Research & Education Foundation, Miami, FL, 33126 USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Yunnan Province (Fourth Affiliated Hospital of Kunming Medical University); Yunnan Eye Institute; Key Laboratory of Yunnan Province for the Prevention and Treatment of ophthalmology (2017DG008); Provincial Innovation Team for Cataract and Ocular Fundus Disease (2017HC010); Expert Workstation of Yao Ke (2017IC064), Kunming 650021, China.""}]",International journal of medical sciences,['10.7150/ijms.39365']
3345,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3346,31809970,Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy: A prospective randomized controlled study.,"OBJECTIVE


This study aimed to investigate the efficacy of hot posterior nasal packing and hot saline irrigation in bleeding control after adenoidectomy.
METHODS


A total of 130 patients scheduled for adenoidectomy were included in the study, and randomized into two groups at the beginning of the surgical operation. After adenoidectomy, saline impregnated tampon, and saline irrigation at room temperature (22 °C) was applied to the patients in one group while 50 °C saline impregnated tampon and saline irrigation at the same temperature were applied to the patients in the other group. We recorded hemostasis for up to 3 min after tamponade for bleeding control, and the amount of bleeding into the nasopharynx.
RESULTS


The age of the patients ranged from 1.5 to 13 years (mean ± SD: 6.07 ± 3.08 years, and 5.33 ± 2.55 years, 22 °C and 50 °C saline irrigation groups, respectively). There were 37 males and 28 females in the 22 °C saline group, while 34 males and 31 females in the 50 °C saline group. When comparing the two groups, there was no statistically significant difference in terms of duration of hemostasis (p = 0.64). However, bleeding scores at 2 nd min after the tamponade were significantly lower in the 50 °C saline group (p = 0.007). The amount of bleeding in the 50 °C saline group was also significantly lower than the 22 °C saline group (p = 0.015).
CONCLUSION


In this study, application of 50 °C saline impregnated tampon, and hot saline irrigation was found to be more effective in the control of bleeding after adenoidectomy by reducing the amount of bleeding compared to 22 °C saline impregnated tampon application and saline irrigation at 22 °C. However, hot nasal packing and hot saline irrigation did not affect duration of hemostasis and cauterization.",2020,"However, bleeding scores at 2 nd min after the tamponade were significantly lower in the 50 °C saline group (p = 0.007).","['hemostasis after adenoidectomy', '37 males and 28 females in the 22\xa0°C saline group, while 34 males and 31 females in the 50\xa0°C saline group', '130 patients scheduled for', 'The age of the patients ranged from 1.5 to 13 years (mean\xa0±\xa0SD: 6.07\xa0±\xa03.08 years, and 5.33\xa0±\xa02.55 years, 22\xa0°C and 50']","['°C saline impregnated tampon application and saline irrigation', 'hot posterior nasal packing and hot saline irrigation', 'hot nasal packing and hot saline irrigation', 'Hot nasal packing with hot saline irrigation', 'adenoidectomy, saline impregnated tampon, and saline irrigation at room temperature', 'adenoidectomy', 'C saline impregnated tampon and saline irrigation', '50\xa0°C saline impregnated tampon, and hot saline irrigation']","['duration of hemostasis', 'amount of bleeding', 'bleeding scores', 'duration of hemostasis and cauterization']","[{'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517791', 'cui_str': '5.33 (qualifier value)'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1704612', 'cui_str': 'Tampon (basic dose form)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007471', 'cui_str': 'Cauterization'}]",130.0,0.0264351,"However, bleeding scores at 2 nd min after the tamponade were significantly lower in the 50 °C saline group (p = 0.007).","[{'ForeName': 'Seyit Mehmet', 'Initials': 'SM', 'LastName': 'Ceylan', 'Affiliation': 'Department of Otorhinolaryngology, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey. Electronic address: drmehmetceylan@hotmail.com.'}, {'ForeName': 'İlyas', 'Initials': 'İ', 'LastName': 'Dişikırık', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, SANKO University, Gaziantep, Turkey. Electronic address: disikirikilyas@hotmail.com.'}, {'ForeName': 'Mahmut Alper', 'Initials': 'MA', 'LastName': 'Kanmaz', 'Affiliation': 'Department of Ear Nose Throat Disease, Sani Konukoğlu Hospital Practice and Research Center, Gaziantep, Turkey. Electronic address: dr.alperkanmaz@gmail.com.'}, {'ForeName': 'Altan', 'Initials': 'A', 'LastName': 'Yıldırım', 'Affiliation': 'Çözüm Ear Nose Throat Center, Gaziantep, Turkey. Electronic address: altan11@hotmail.com.'}, {'ForeName': 'Efe', 'Initials': 'E', 'LastName': 'Sezgin', 'Affiliation': 'Laboratory of Nutrigenomics and Epidemiology, Department of Food Engineering, İzmir Institute of Technology, İzmir, Turkey. Electronic address: efeszgn0@gmail.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2019.109792']
3347,31955968,Investigation of the Minimum Local Analgesic Concentration of Epidural Sufentanil Combined With Ropivacaine for Labor Analgesia.,"PURPOSE


Worldwide, there are only few studies focusing on labor analgesia on the MLAC (minimum local analgesic concentration) or EC50 (median effective concentration) of sufentanil and ropivacaine. Therefore, we determine the MLAC or EC50 of sufentanil and ropivacaine for epidural analgesia by using an up-down sequential allocation and survey its adverse effect in a prospective blinded randomized trial.
METHODS


Sixty nulliparous full-term parturients who required labor analgesia were recruited and randomly divided into the sufentanil and ropivacaine groups. The formulation was 25 μg sufentanil combined with 0.1% ropivacaine (added 0.9% normal saline to 75 ml). According to the response of a previous parturient, the dosage of sufentanil was increased or decreased by 5 μg in the sufetanil group; meanwhile, we also administrated an initial concentration of 0.1% ropivacaine combined with 22.5 μg sufentanil (added 0.9% normal saline to 75 ml) in the ropivacaine group. The concentration of ropivacaine was increased or decreased by 0.01% following the response of the previous parturient. The Brownlee up-down sequential allocation was used to estimate the MLAC of epidural ropivacaine and its 95% confidence intervals in labor analgesia.
FINDINGS


There were no significant changes for the two groups, including for age, height weight, active stage, second stage of labor, and gestational weeks (P = 0.769, 0.900, 0.603, 0.441, 0.577, and 0.695, respectively). The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min. The EC50 dose of epidural ropivacaine combined with 0.3 μg/mL sufentanil was 0.09687%, and the 95% CI was 0.08944%~0.1043%. Five parturients had PONV, and the incidence rate was 16.7%; one parturient had pruritus, so the incidence rate was 3.3%. The EC50 dose of epidural sulfetanil combined with 0.1% ropivacaine was 18.76 μg with a 95% confidence interval of 13.5-24.48 μg. There were no significant differences in the active stage, second stage of labor, and maternal and fetal hemodynamic data between the two groups. Notably, the Apgar scores for 1 min and 5 min were 10 scores for almost all of these patients. There were no significant differences between the two groups for maternal and fetal side effects, which had very low incidence rates.
IMPLICATIONS


The MLAC of epidural sufentanil or ropivacaine could provide satisfactory and safe analgesia for parturients while having a low incidence rate of side effects.",2020,"The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min.","['Labor Analgesia', 'Sixty nulliparous full-term parturients who required labor analgesia']","['Epidural Sufentanil Combined With Ropivacaine', 'ropivacaine', 'sufentanil combined with 0.1% ropivacaine', 'ropivacaine combined with 22.5 μg sufentanil', 'mL sufentanil', 'sufentanil', 'sufentanil and ropivacaine', 'epidural ropivacaine']","['active stage, second stage of labor, and maternal and fetal hemodynamic data', 'Apgar scores', 'incidence rate', 'VAS scores', 'maternal and fetal side effects', 'effective analgesia', 'concentration of ropivacaine']","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]",,0.245689,"The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'School of Nursing, Guangdong Pharmaceutical University, Guangzhou, 510310, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China.'}, {'ForeName': 'Wangping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital, Jiaxing University, Jiaxing 314000, China. Electronic address: zhang650679@163.com.""}, {'ForeName': 'Zeyong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China. Electronic address: yankylge@aliyun.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.10.011']
3348,32034447,Nicotine patch for cannabis withdrawal symptom relief: a randomized controlled trial.,"RATIONALE


Given that tetrahydrocannabinol (THC) and nicotine have similar effects on negative affect (NA), we hypothesized that a 7-mg nicotine patch (NP) would reduce NA-related cannabis (CAN) withdrawal symptoms in cannabis-dependent (CD) individuals who were not nicotine dependent.
OBJECTIVE


We sought to determine whether NP reduces NA across 15 days of CAN abstinence in two groups: non-tobacco smokers (NTS) and light tobacco smokers (LTS).
METHODS


CD participants (N = 127; aged 18-35) who used CAN at least 5 times/week for the past 12 + months were randomized to (1) NP or (2) a placebo patch (PP) and received $300 for sustained biochemically verified CAN abstinence. Of those randomly assigned, 52 of 63 NP, and 56 of 64 PP maintained biochemically verified CAN abstinence and 51 NP and 50 PP participants complied with all aspects of the study. Affect and other withdrawal symptoms were measured every 48 h across 15 days of CAN abstinence.
RESULTS


After controlling for age, tobacco use, baseline THC concentration, and baseline measurements of the dependent variable, NP reduced NA symptoms across the 15-day treatment relative to PP. Differences in NA and CAN withdrawal symptoms were not moderated by tobacco user status.
CONCLUSIONS


The findings provide the first evidence that NP may be able to attenuate NA-related withdrawal symptoms in individuals with cannabis use disorder who are not heavy users of tobacco or nicotine.
CLINICAL TRIALS REGISTRY


NCT01400243 http://www.clinicaltrials.gov.",2020,"Differences in NA and CAN withdrawal symptoms were not moderated by tobacco user status.
","['CD participants (N\u2009=\u2009127; aged 18-35) who used CAN at least 5 times/week for the past 12\u2009+ months', 'two groups: non-tobacco smokers (NTS) and light tobacco smokers (LTS', 'cannabis-dependent (CD) individuals who were not nicotine dependent', 'individuals with cannabis use disorder who are not heavy users of tobacco or nicotine']","['placebo patch (PP', 'NP reduces NA', 'nicotine patch (NP', 'tetrahydrocannabinol (THC) and nicotine', 'Nicotine patch']","['cannabis withdrawal symptom relief', 'withdrawal symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456698', 'cui_str': 'times/week (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C3494624', 'cui_str': 'Current light tobacco smoker'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C3840212', 'cui_str': 'Cannabis withdrawal (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",,0.596759,"Differences in NA and CAN withdrawal symptoms were not moderated by tobacco user status.
","[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychology, Southern Illinois University, Carbondale, USA. dgilbert@siu.edu.'}, {'ForeName': 'Norka E', 'Initials': 'NE', 'LastName': 'Rabinovich', 'Affiliation': 'Department of Psychology, Southern Illinois University, Carbondale, USA.'}, {'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'McDaniel', 'Affiliation': 'Department of Public Health and Recreation Professions, Southern Illinois University, Carbondale, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05476-1']
3349,29532416,The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial.,"Data on the effects of synbiotic supplementation on glycemic control, lipid profiles, and atherogenic index of plasma (AIP) of women with polycystic ovary syndrome (PCOS) are limited. The purpose of this study was to assess the effects of synbiotic supplementation on glycemic control and lipid profiles in women with PCOS. A prospective, randomized, double-blind, placebo-controlled trial was done at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017. Sixty women with PCOS were randomized to intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 10 9  CFU/g each) plus 800 mg inulin (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related variables. Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001). In addition, significant decreases in serum triglycerides (- 16.2 ± 31.4 vs. + 5.8 ± 23.1 mg/dL, P = 0.003), VLDL-cholesterol concentrations (- 3.3 ± 6.3 vs. + 1.1 ± 4.6 mg/dL, P = 0.003), and AIP (- 0.05 ± 0.08 vs. - 0.003 ± 0.10 mg/dL, P = 0.03) were seen following the supplementation of synbiotic compared with the placebo. Overall, we found that synbiotic supplementation to women with PCOS for 12 weeks had beneficial effects on markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP, but did not influence other lipid profiles. Trial registration: www.irct.ir: IRCT201604015623N71.",2019,"Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001).","['women with PCOS', 'women with polycystic ovary syndrome (PCOS', 'Sixty women with PCOS', 'Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017', 'Women With Polycystic Ovary Syndrome']","['placebo', 'Synbiotic Supplementation', 'intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771', 'placebo, synbiotic supplementation', 'synbiotic supplementation']","['serum insulin concentrations', 'VLDL-cholesterol concentrations', 'homeostasis model of assessment-insulin resistance', 'glycemic control, lipid profiles, and atherogenic index of plasma (AIP', 'quantitative insulin sensitivity check index', 'markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP', 'serum triglycerides', 'Fasting blood samples', 'Metabolic Status', 'glycemic control and lipid profiles']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",60.0,0.641325,"Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001).","[{'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Dadkhah', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Haddad Kashani', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Science Faculty, Islamic Azad University, Central Branch, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Seyed Hosseini', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9405-z']
3350,31883703,"A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics After High-volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers.","PURPOSE


Gantenerumab, a fully human anti-amyloid-β IgG1 monoclonal antibody that binds to aggregated forms of amyloid-β, is being investigated as a potential disease-modifying treatment for early (prodromal to mild) Alzheimer disease (AD). Our study compared the pain associated with 5- and 15-s subcutaneous injections of gantenerumab and evaluated the tolerability and pharmacokinetic properties of subcutaneous gantenerumab.
METHODS


This randomized, open-label, single-active-dose, placebo-controlled crossover study was conducted in 50 healthy volunteers aged 40-80 years with no history of clinically significant disorders, drug or alcohol abuse, familial history of early-onset AD, or prior gantenerumab exposure. Eligible participants were randomized to a sequence of one 300-mg SC gantenerumab injection into the abdomen and 2 SC placebo injections (1 into the abdomen and 1 into the thigh) during 5 or 15 s. All injections were administered at least 90 min apart. Participants were assessed for local pain by visual analog scale (VAS) and verbal rating scale; safety profiles were assessed by recording adverse events (AEs), and plasma pharmacokinetic properties were also evaluated.
FINDINGS


Immediately after the subcutaneous gantenerumab injection, the pain VAS score was numerically higher without reaching statistical significance in the 5-s versus 15-s injection group (VAS least-squares mean difference, 7.492 mm; 95% CI, -4.439-19.423 mm). In both injection speed groups, the mean pain VAS score was comparable after subcutaneous gantenerumab and placebo injections into the abdomen. Pain was reported after needle insertion and immediately after dosing, subsiding within 5 min after the dose. The pain VAS score was numerically higher after SC placebo injection into the thigh versus abdomen (5-s injection group: mean [SD] VAS score, 26.68 [27.83] vs 19.20 [25.60] mm; 15-s injection group: mean [SD] VAS score, 14.16 [20.62] vs 9.48 [12.04] mm). No serious AEs were reported; no participants withdrew because of an AE. All AEs were of mild intensity, were transient, and had resolved without sequelae at follow-up. The most common AEs were injection site reactions; redness was the most frequently observed skin reactivity event after subcutaneous gantenerumab administration (5-s injection group: 36%; 15-s injection group: 32%). After subcutaneous administration, gantenerumab reached a peak plasma concentration at a median time of 119 h (approximately 5 days); plasma concentrations declined in a monoexponential manner. Comparable pharmacokinetic profiles were observed between the injection speed groups.
IMPLICATIONS


Subcutaneous gantenerumab injections at speeds of 5 and 15 s were well tolerated in healthy volunteers and could enable at-home administration by patients with AD or their caregivers. ClinicalTrials.gov identifier: NCT02882009.",2020,"FINDINGS


Immediately after the subcutaneous gantenerumab injection, the pain VAS score was numerically higher without reaching statistical significance in the 5-s versus 15-s injection group (VAS least-squares mean difference, 7.492 mm; 95% CI, -4.439-19.423 mm).","['Healthy Volunteers', '50 healthy volunteers aged 40-80 years with no history of clinically significant disorders, drug or alcohol abuse, familial history of early-onset AD, or prior gantenerumab exposure', 'Eligible participants', 'healthy volunteers']","['placebo', 'Gantenerumab', 'Subcutaneous gantenerumab injections', '300-mg SC gantenerumab injection into the abdomen and 2 SC placebo injections']","['pain VAS score', 'plasma concentrations', 'Pain', 'peak plasma concentration', 'mean pain VAS score', 'Pain, Tolerability, and Pharmacokinetics', 'adverse events (AEs), and plasma pharmacokinetic properties', 'local pain by visual analog scale (VAS) and verbal rating scale; safety profiles', 'tolerability and pharmacokinetic properties', 'injection site reactions; redness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2982066', 'cui_str': 'gantenerumab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2982066', 'cui_str': 'gantenerumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}]",50.0,0.237961,"FINDINGS


Immediately after the subcutaneous gantenerumab injection, the pain VAS score was numerically higher without reaching statistical significance in the 5-s versus 15-s injection group (VAS least-squares mean difference, 7.492 mm; 95% CI, -4.439-19.423 mm).","[{'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Portron', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jordan', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Draper', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Muenzer', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': 'PRA Health Sciences, Lenexa, KS, USA.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'van Iersel', 'Affiliation': 'PRA Health Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Hofmann', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland. Electronic address: carsten.hofmann@roche.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.015']
3351,31419313,Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial.,"In the absence of an intervening antiresorptive agent, cyclic administration of teriparatide does not increase bone mineral density (BMD) more than standard daily therapy. Because denosumab is a potent antiresorptive agent with a rapid off-effect, we hypothesized that it might be the optimal agent to help maximize bone gains with cyclic teriparatide. In this 3-year protocol, 70 postmenopausal women with osteoporosis were randomized to 18 months of teriparatide followed by 18 months of denosumab (standard) or three separate 12-month cycles of 6 months of teriparatide followed by 6 months of denosumab (cyclic). BMD (dual-energy X-ray absorptiometry [DXA]) measurements of lumbar spine (LS), total hip (TH), femoral neck (FN), and 1/3 radius (RAD) were performed every 6 months and total body bone mineral (TBBM) at 18 and 36 months. Baseline descriptive characteristics did not differ between groups except for a minimal difference in LS BMD but not T-score (mean age 65 years, mean LS T-score - 2.7). In the standard group, BMD increments at 36 months were: LS 16%, TH 4%, FN 3%, and TBBM 4.8% (all p < 0.001 versus baseline). In the cyclic group, 36-month BMD increments were similar: LS 12%, TH 4%, FN 4%, and TBBM 4.1% (all p < 0.001 versus baseline). At 36 months, the LS BMD increase with standard was slightly larger than with cyclic (p = 0.04), but at 18 months, in the cyclic group, there was no decline in RAD or TBBM (p = 0.007 and < 0.001, respectively, versus standard). Although the cyclic regimen did not improve BMD compared with standard at 36 months, there appeared to be a benefit at 18 months, especially in the highly cortical skeletal sites. This could be clinically relevant in patients at high imminent risk of fracture, particularly at nonvertebral sites. © 2019 American Society for Bone and Mineral Research. © 2019 American Society for Bone and Mineral Research.",2020,"At 36 months, the LS BMD increase with Standard was slightly larger than with Cyclic (p=0.04), but at 18 months, in the Cyclic group, there was no decline in RAD or TBBM (p=0.007 and <0.001, respectively vs Standard).","['70 postmenopausal women with osteoporosis', 'patients at high imminent risk of fracture, particularly at nonvertebral sites', 'Osteoporosis']","['teriparatide followed by 18 months denosumab (Standard) or 3 separate 12 month cycles of 6 months teriparatide followed by 6 months denosumab (Cyclic', 'Cyclic Teriparatide and Denosumab', 'teriparatide']","['36-month BMD increments', 'RAD or TBBM', 'LS BMD', 'BMD', 'BMD (DXA) measurements of lumbar spine (LS), total hip (TH), femoral neck (FN), and 1/3 radius (RAD', 'BMD increments', 'Total Body Bone Mineral (TBBM']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}]",70.0,0.0642221,"At 36 months, the LS BMD increase with Standard was slightly larger than with Cyclic (p=0.04), but at 18 months, in the Cyclic group, there was no decline in RAD or TBBM (p=0.007 and <0.001, respectively vs Standard).","[{'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'McMahon', 'Affiliation': 'Clinical Research Center, Helen Hayes Hospital, West Haverstraw, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dempster', 'Affiliation': 'Department of Pathology and Cell Biology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeri W', 'Initials': 'JW', 'LastName': 'Nieves', 'Affiliation': 'Clinical Research Center, Helen Hayes Hospital, West Haverstraw, NY, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3850']
3352,32024950,"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).","Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or died divided by total duration of progression-free survival [PFS] in patient-years; co-primary endpoint) for intense, intermediate, and short dosing were 0.055 (80% confidence interval [CI], 0.014-0.096), 0.102 (80% CI, 0.044-0.160), and 0.206 (80% CI, 0.118-0.295), respectively, translating to a median PFS ≥24 months in all arms (P < 0.0001, <0.0001, and =0.0213, respectively). With longer follow-up (median follow-up, 25.9 months), CR rates were 4.9%, 9.8%, and 0% for intense, intermediate, and short dosing, respectively. PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms). Twenty-four-month PFS rates were 89.9% (90% CI, 78.5-95.4%), 82.0% (90% CI, 69.0-89.9%), and 75.3% (90% CI, 61.1-85.0%) for intense, intermediate, and short dosing, respectively. Pharmacokinetic analyses indicated that intense dosing maintained target-saturating trough concentrations in most patients throughout weekly, every-2-week, and every-4-week dosing periods. No new safety signals were observed. These data provide the basis for an ongoing phase 3 study of daratumumab in SMM.",2020,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","['patients with intermediate-risk or high-risk smoldering multiple myeloma', '123 patients with intermediate-risk or high-risk SMM']","['Daratumumab monotherapy', 'daratumumab 16\u2009mg/kg intravenously on extended intense (intense), extended intermediate (intermediate']","['Progressive disease (PD)/death rates', 'CR rates', 'CR rate', 'PD/death rates', 'PFS rates', 'complete response (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",123.0,0.0578349,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","[{'ForeName': 'C Ola', 'Initials': 'CO', 'LastName': 'Landgren', 'Affiliation': 'Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA. landgrec@mskcc.org.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': 'Department of Hematology, Tel-Aviv Sourasky (Ichilov) Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Haematology, Nottingham University Hospitals, Nottinghamshire, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Hematology & Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA. Craig.Hofmeister@emory.edu.'}]",Leukemia,['10.1038/s41375-020-0718-z']
3353,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3354,31813542,Hypnosis Program Effectiveness in a 12-week Home Care Intervention To Manage Chronic Pain in Elderly Women: A Pilot Trial.,"PURPOSE


As the prevalence of pain increases with age, taking too much medication can lead to negative side effects in elderly patients. While evidence in the literature has shown that clinical hypnosis is effective in an adult population, there are few studies in an aging population and efficacy has never been established in a home care setting. The goal of this study was to determine the effects of a hypnosis program delivered during home care interventions in elderly women during a 12-week period.
METHODS


This pilot trial took place from April 2016 to October 2017 at Limoges, France. Fifteen elderly women with chronic pain participated (81 (65-87) years old). All participants presented chronic pain for more than 6 months (inclusion criteria: average pain score >4/10). Participants took part in three 15-min hypnosis sessions separated by four to six weeks. Each hypnosis session was personalized and carried out with induction, pain perception alteration, and post-hypnotic suggestions. Pain perception and pain interference were evaluated with the Brief Pain Inventory questionnaire, and compared between before and after the 12-week hypnosis program.
FINDINGS


Hypnosis home care program significantly improved scores on worst (8.9 to 6.7, P < 0.001), average (6.8 to 5.1, P < 0.001), and current pain perception (6.5 to 3.9, P < 0.001), pain interference with physical activity (P < 0.001) and with socio-affective factors (P < 0.01).
IMPLICATIONS


Taken together, these findings show that a hypnosis intervention is feasible and effective to manage pain in an elderly population.",2020,"FINDINGS


Hypnosis home care program significantly improved scores on worst (8.9 to 6.7, P < 0.001), average (6.8 to 5.1, P < 0.001), and current pain perception (6.5 to 3.9, P < 0.001), pain interference with physical activity (P < 0.001) and with socio-affective factors (P < 0.01).
","['Elderly Women', 'Fifteen elderly women with chronic pain participated (81 (65-87) years old', 'elderly women during a 12-week period', 'April 2016 to October 2017 at Limoges, France', 'elderly patients']","['Home Care Intervention', 'hypnosis intervention', 'hypnosis program']","['Pain perception and pain interference', 'Brief Pain Inventory questionnaire', 'pain interference with physical activity', 'current pain perception', 'chronic pain']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",15.0,0.0248422,"FINDINGS


Hypnosis home care program significantly improved scores on worst (8.9 to 6.7, P < 0.001), average (6.8 to 5.1, P < 0.001), and current pain perception (6.5 to 3.9, P < 0.001), pain interference with physical activity (P < 0.001) and with socio-affective factors (P < 0.01).
","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Billot', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; HAVAE EA 6310 Laboratory, University of Limoges, Limoges, France; PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France. Electronic address: maxime.billot@chu-poitiers.fr.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Jaglin', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; UPSAV, Department of Clinical Geriatric, University Hospital Center, Limoges, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Rainville', 'Affiliation': 'Department of Stomatology and the Montreal Research Center, Institute of Geriatrics, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rigoard', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France; Spine & Neuromodulation Functional Unit, Poitiers University Hospital, Poitiers, France; Prime Institute, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Langlois', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Noëlle', 'Initials': 'N', 'LastName': 'Cardinaud', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; UPSAV, Department of Clinical Geriatric, University Hospital Center, Limoges, France.'}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Tchalla', 'Affiliation': 'Department of Clinical Geriatric, University Hospital Center, Limoges, France; HAVAE EA 6310 Laboratory, University of Limoges, Limoges, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': 'PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.11.007']
3355,32015461,"Double blind, two dose, randomized, placebo-controlled, cross-over clinical trial of the positive allosteric modulator at the alpha7 nicotinic cholinergic receptor AVL-3288 in schizophrenia patients.","Despite their theoretical rationale, nicotinic alpha-7 acetylcholine (nα 7 ) receptor agonists, have largely failed to demonstrate efficacy in placebo-controlled trials in schizophrenia. AVL-3288 is a nα 7  positive allosteric modulator (PAM), which is only active in the presence of the endogenous ligand (acetylcholine), and thus theoretically less likely to cause receptor desensitization. We evaluated the efficacy of AVL-3288 in a Phase 1b, randomized, double-blind, placebo-controlled, triple cross-over study. Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) ≥62 were randomized. Each subject received 5 days of AVL-3288 (10, 30 mg) and placebo across three separate treatment weeks. The primary outcome measure was the RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker. Secondary outcome measures include task-based fMRI (RISE task), mismatch negativity, the Scale for the Assessment of Negative Symptoms of Schizophrenia (SANS) and the Brief Psychiatric Rating Scale (BPRS). Twenty-four subjects were randomized and treated without any clinically significant treatment emergent adverse effects. Baseline RBANS (82 ± 17) and BPRS (41 ± 13) scores were consistent with moderate impairment. Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS. In conclusion, the results did not indicate efficacy of the compound, consistent with most prior results for the nα 7  target.",2020,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","['schizophrenia patients', 'Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a repeatable battery for the assessment of neuropsychological status (RBANS) ≥62 were randomized']","['placebo', 'AVL-3288']","['task-based fMRI (RISE task), mismatch negativity, the scale for the assessment of negative symptoms of schizophrenia (SANS) and the brief psychiatric rating scale (BPRS', 'RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449216', 'cui_str': 'aVL (body structure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3850132', 'cui_str': 'P50 Wave'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",24.0,0.429793,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, USA. jk3380@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freedman', 'Affiliation': 'U Colorado, Denver, CO, USA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Vail', 'Affiliation': 'New York State Psychiatric Institute, New York, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0628-9']
3356,30076614,Terlipressin Is Superior to Noradrenaline in the Management of Acute Kidney Injury in Acute on Chronic Liver Failure.,"Hepatorenal syndrome (HRS) carries a high short-term mortality in patients with cirrhosis and acute on chronic liver failure (ACLF). Terlipressin and noradrenaline are routinely used in cirrhosis with HRS and have been found to be equally effective. There are no data comparing the efficacy of terlipressin with noradrenaline in ACLF patients with HRS. In an open-label, randomized controlled trial (RCT), consecutive patients with ACLF diagnosed with HRS acute kidney injury (AKI) were randomized to albumin with infusion of terlipressin (2-12 mg/day; n = 60) or noradrenaline (0.5-3.0 mg/h; n = 60). Response to treatment, course of AKI, and outcome were studied. Baseline characteristics, including AKI stage and sepsis-related HRS-AKI, were comparable between groups. Compared to noradrenaline, terlipressin achieved greater day 4 (26.1% vs. 11.7%; P = 0.03) and day 7 (41.7% vs. 20%; P = 0.01) response. Reversal of HRS was also better with terlipressin (40% vs. 16.7%; P = 0.004), with a significant reduction in the requirement of renal replacement therapy (RRT; 56.6% vs. 80%; P = 0.006) and improved 28-day survival (48.3% vs. 20%; P = 0.001). Adverse events limiting use of drugs were higher with terlipressin than noradrenaline (23.3% vs. 8.3%; P = 0.02), but were reversible. On multivariate analysis, high Model for End-Stage Liver Disease (MELD; odds ratio [OR], 1.10; confidence interval [CI] = 1.009-1.20; P = 0.03) and noradrenaline compared to terlipressin (OR, 3.05; CI = 1.27-7.33; P = 0.01) predicted nonresponse to therapy. Use of noradrenaline compared to terlipressin was also predictive of higher mortality (hazard ratio [HR], 2.08; CI = 1.32-3.30; P = 0.002). Conclusion: AKI in ACLF carries a high mortality. Infusion of terlipressin gives earlier and higher response than noradrenaline, with improved survival in ACLF patients with HRS-AKI.",2020,"Infusion of terlipressin gives earlier and higher response than noradrenaline, with improved survival in ACLF patients with HRS-AKI.","['ACLF patients with HRS-AKI', 'Acute Kidney Injury in Acute on Chronic Liver Failure', 'patients with cirrhosis and acute on chronic liver failure (ACLF', 'ACLF patients with HRS', 'consecutive patients with ACLF diagnosed with HRS acute kidney injury (AKI']","['albumin with infusion of terlipressin', 'terlipressin', 'ACLF', 'Terlipressin and noradrenaline', 'noradrenaline', 'Terlipressin', 'Noradrenaline']","['survival', 'requirement of renal replacement therapy', 'Reversal of HRS', '28-day survival', 'Hepatorenal syndrome (HRS', 'AKI stage and sepsis-related HRS-AKI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C3850141', 'cui_str': 'Acute-On-Chronic Liver Failure (ACLF)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.192818,"Infusion of terlipressin gives earlier and higher response than noradrenaline, with improved survival in ACLF patients with HRS-AKI.","[{'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Maiwall', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Vijayaraghavan', 'Initials': 'V', 'LastName': 'Rajan', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Jindal', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Saggere', 'Initials': 'S', 'LastName': 'Muralikrishna Shasthry', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Guresh', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Department of Clinical Research and Biostatistics, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Clinical Research and Biostatistics, Institute of Liver and Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30208']
3357,31601514,COMPARZ Post Hoc Analysis: Characterizing Pazopanib Responders With Advanced Renal Cell Carcinoma.,"BACKGROUND


The phase III COMPARZ study showed noninferior efficacy of pazopanib versus sunitinib in advanced renal cell carcinoma. In this COMPARZ post hoc analysis we characterized pazopanib responders, patient subgroups with better outcomes, and the effect of dose modification on efficacy and safety.
PATIENTS AND METHODS


Patients were randomized to pazopanib 800 mg/d (n = 557) or sunitinib 50 mg/d, 4 weeks on/2 weeks off (n = 553). Secondary end points included time to complete response (CR)/partial response (PR); the proportion of patients with CR/PR ≥10 months and progression-free survival (PFS) ≥10 months; efficacy in patients with baseline metastasis; and logistic regression analyses of patient characteristics associated with CR/PR ≥10 months. Median PFS, objective response rate (ORR), and safety were evaluated in patients with or without dose reductions or interruptions lasting ≥7 days.
RESULTS


Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks). Similar percentages of pazopanib and sunitinib patients had CR/PR ≥10 months (14% and 13%, respectively), and PFS ≥10 months (31% and 34%, respectively). For patients without versus with adverse event (AE)-related dose reductions, median PFS, median overall survival, and ORR were 7.3 versus 12.5 months, 21.7 versus 36.8 months, and 22% versus 42% (all P < .0001) for pazopanib, and 5.5 versus 13.8 months, 18.1 versus 38.0 months, and 16% versus 34% (all P < .0001) for sunitinib; results were similar for dose interruptions.
CONCLUSION


Dose modifications when required because of AEs were associated with improved efficacy, suggesting that AEs might be used as a surrogate marker of adequate dosing for individual patients.",2019,"RESULTS


Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks).","['Patients', 'advanced renal cell carcinoma', 'Responders With Advanced Renal Cell Carcinoma']","['Pazopanib', 'pazopanib', 'COMPARZ Post', 'sunitinib']","['Median time to response', 'efficacy and safety', 'time to complete response (CR)/partial response (PR); the proportion of patients with CR/PR\xa0≥10 months and progression-free survival (PFS)\xa0≥10 months; efficacy', 'median PFS, median overall survival, and ORR', 'Median PFS, objective response rate (ORR), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.108855,"RESULTS


Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks).","[{'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medicine, Hematology/Oncology, New York, NY. Electronic address: cns9006@cornell.med.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Texas Oncology/Baylor Sammons Cancer Center, Dallas, TX.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, The University of British Columbia, BCCA Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Georg A', 'Initials': 'GA', 'LastName': 'Bjarnason', 'Affiliation': 'Division of Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Paul Nathan', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Center, Northwood, United Kingdom.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Medical Oncology, I.R.C.C.S. San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'University Hospital Essen, West-German Cancer Center, Internal Medicine (Tumor research) and Clinic for Urology, Essen, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dezzani', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.01.015']
3358,27029706,Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1).,"BACKGROUND


To evaluate the influence of treatment on health-related quality of life (HRQoL) in 919 women with recurrent ovarian cancer enrolled in the TRINOVA-1 study, a randomized, placebo-controlled phase III study that demonstrated that trebananib 15 mg/kg QW plus weekly paclitaxel significantly improved progression-free survival (PFS) compared with placebo plus weekly paclitaxel (7.2 versus 5.4 months; hazard ratio, 0.66; 95% confidence interval 0.57-0.77; P < 0.001).
PATIENTS AND METHODS


HRQoL was assessed with the Functional Assessment of Cancer Therapy-Ovary [FACT-O; comprising FACT-G and the ovarian cancer-specific subscale (OCS)] and EuroQOL EQ-5D instruments before treatment on day 1 of weeks 1, 5, 9, 13, 17, and every 8 weeks thereafter and at the safety follow-up visit. A pattern-mixture model was used to evaluate the influence of patient dropout on FACT-O and OCS scores over time.
RESULTS


Of 919 randomized patients, 834 (91%) had a baseline and ≥1 post-baseline HRQoL assessment. At baseline, scores for all instruments were similar for both arms. At 25 weeks, mean ± SD changes from baseline were negligible, with mean ± SD changes typically <1 unit from baseline: -2.4 ± 16.6 in the trebananib arm and -1.6 ± 15.2 in the placebo arm for FACT-O, -0.71 ± 5.5 in the trebananib arm and -0.86 ± 4.9 in the placebo arm for OCS, and -0.02 ± 0.22 in the trebananib arm and 0.02 ± 0.19 in the placebo arm for EQ-5D. Distribution of scores was similar between treatment arms at baseline and over the course of the study. In pattern-mixture models, there was no evidence that patient dropout affected differences in mean FACT-O or OCS scores. Edema had limited effect on either FACT-O or OCS scores in patients with grade ≥2 edema or those with grade 1 or no edema.
CONCLUSIONS


Our results demonstrate that the improvement in PFS among patients in the trebananib arm in the TRINOVA-1 study was achieved without compromising HRQoL.
CLINICALTRIALSGOV IDENTIFIER


NCT01204749.",2016,"In pattern-mixture models, there was no evidence that patient dropout affected differences in mean FACT-O or OCS scores.","['919 women with recurrent ovarian cancer', 'Of 919 randomized patients, 834 (91%) had a baseline and ≥1 post-baseline HRQoL assessment', 'women with recurrent ovarian cancer receiving']","['trebananib 15 mg/kg QW plus weekly paclitaxel', 'paclitaxel plus trebananib or placebo (TRINOVA-1', 'placebo', 'placebo plus weekly paclitaxel']","['Health-related quality of life', 'FACT-O and OCS scores', 'Functional Assessment of Cancer Therapy-Ovary [FACT-O; comprising FACT-G and the ovarian cancer-specific subscale (OCS', 'PFS', 'health-related quality of life (HRQoL', 'EQ-5D. Distribution of scores', 'mean FACT-O or OCS scores', 'FACT-O or OCS scores', 'progression-free survival (PFS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3660912', 'cui_str': 'trenananib'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029939', 'cui_str': 'Ovary'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",919.0,0.650464,"In pattern-mixture models, there was no evidence that patient dropout affected differences in mean FACT-O or OCS scores.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi, Japan. Electronic address: fujiwara@saitama-med.ac.jp.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""University of Arizona Cancer Center at Saint Joseph's Hospital and Medical Center, Phoenix, USA.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lhommé', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology, University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brize', 'Affiliation': 'Hematology & Chemotherapy, Riga East Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Department of Medicine, Centre Léon Bérard and University Claude Bernard, Lyon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fabbro', 'Affiliation': 'Medical Oncology, Institut Régional du Cancer Montpellier, Montpellier, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': ""Department of Obstetrics and Gynecology, Centre Hospitalier de L'Université de Montreal Notre-Dame, Montreal, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'Department of Clinical Therapeutics, Alexandra Hospital, Athens, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'University Hospitals-KU Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': 'Medical Oncology, Ente Ospedaliero Ospedali Galliera, Genova, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Amgen Inc., Thousand Oaks, USA.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Vogl', 'Affiliation': 'Amgen Inc., Thousand Oaks, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Bach', 'Affiliation': 'Amgen Inc., Thousand Oaks, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Surgery, Fondazione IRCCS Istituto Nazionale per la Cura e lo Studio dei Tumori, Milan, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw147']
3359,26940689,Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV 'real life' trial on the variability of response to opioids.,"BACKGROUND


Guidelines tend to consider morphine and morphine-like opioids comparable and interchangeable in the treatment of chronic cancer pain, but individual responses can vary. This study compared the analgesic efficacy, changes of therapy and safety profile over time of four strong opioids given for cancer pain.
PATIENT AND METHODS


In this four-arm multicenter, randomized, comparative, of superiority, phase IV trial, oncological patients with moderate to severe pain requiring WHO step III opioids were randomly assigned to receive oral morphine or oxycodone or transdermal fentanyl or buprenorphine for 28 days. At each visit, pain intensity, modifications of therapy and adverse drug reactions (ADRs) were recorded. The primary efficacy end point was the proportion of nonresponders, meaning patients with worse or unchanged average pain intensity (API) between the first and last visit, measured on a 0-10 numerical rating scale. (NCT01809106).
RESULTS


Forty-four centers participated in the trial and recruited 520 patients. Worst pain intensity and API decreased over 4 weeks with no significant differences between drugs. Nonresponders ranged from 11.5% (morphine) to 14.4% (buprenorphine). Appreciable changes were made in the treatment schedules over time. Each group required increases in the daily dose, from 32.7% (morphine) to 121.2% (transdermal fentanyl). Patients requiring adjuvant analgesics ranged from 68.9% (morphine) to 81.6% (oxycodone), switches varied from 22.1% (morphine) to 12% (oxycodone), discontinuation of treatment from 27% ( morphine) to 14.5% (fentanyl). ADRs were similar except for effects on the nervous system, which significantly prevailed with morphine.
CONCLUSION


The main findings were the similarity in pain control, response rates and main adverse reactions among opioids. Changes in therapy schedules were notable over time. A considerable proportion of patients were nonresponders or poor responders.
CLINICAL TRIAL REGISTRATION


NCT01809106 (https://clinicaltrials.gov/ct2/show/NCT01809106?term=cerp&rank=2).",2016,Worst pain intensity and API decreased over 4 weeks with no significant differences between drugs.,"['oncological patients with moderate to severe pain requiring WHO step III opioids', 'Forty-four centers participated in the trial and recruited 520 patients']","['morphine and morphine-like opioids', 'oral morphine or oxycodone or transdermal fentanyl or buprenorphine']","['pain intensity, modifications of therapy and adverse drug reactions (ADRs', 'Worst pain intensity and API', 'pain control, response rates and main adverse reactions', 'analgesic efficacy', 'proportion of nonresponders, meaning patients with worse or unchanged average pain intensity (API']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0390024', 'cui_str': 'API0134'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}]",520.0,0.0785299,Worst pain intensity and API decreased over 4 weeks with no significant differences between drugs.,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Corli', 'Affiliation': 'Department of Oncology, Unità di Ricerca nel Dolore e Cure Palliative. Electronic address: oscar.corli@marionegri.it.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Floriani', 'Affiliation': 'Department of Oncology, Laboratorio di Ricerca Clinica, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roberto', 'Affiliation': 'Department of Oncology, Unità di Ricerca nel Dolore e Cure Palliative.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montanari', 'Affiliation': 'Department of Oncology, Unità di Ricerca nel Dolore e Cure Palliative.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Department of Oncology, Laboratorio di Ricerca Clinica, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Greco', 'Affiliation': 'Department of Oncology, Unità di Ricerca nel Dolore e Cure Palliative; Department of Statistics, Università di Milano, Milan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caraceni', 'Affiliation': 'Palliative Care Complex Structure, Terapia del dolore e Riabilitazione, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kaasa', 'Affiliation': 'Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Norway.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Dragani', 'Affiliation': 'S.S.D. Epidemiology, Genetics and Pharmacogenomics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Azzarello', 'Affiliation': 'Department of Hematology and Oncology, Ospedale di U.O.C. di Oncologia Mirano-ASL 13 Regione Veneto, Mirano.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Luzzani', 'Affiliation': 'Department of Orthogeriatrics, S.S.D. Cure Palliative, riabilitazione e stabilizzazione E.O. Ospedali Galliera, Genova.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Oncology Unit, Ospedale di Piacenza, Piacenza.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bandieri', 'Affiliation': 'Unit of Supportive and Simultaneous Care, Medical Oncology Division USL, Modena.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gamucci', 'Affiliation': 'UOC Medical Oncology, Ospedale SS Trinità, Sora.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lipari', 'Affiliation': 'Palliative Care, P.O. di Salemi-ASP 9, Trapani.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Di Gregorio', 'Affiliation': 'U.O.S Obstetric Anasthesia and Pain Therapy, Opedale Sacro Cuore di Gesù - Fatebenefratelli, Benevento.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Valenti', 'Affiliation': 'Palliative Care Unit, Azienda Ospedaliera Valtellina e Valchiavenna, Morbegno.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Reale', 'Affiliation': 'Department of Cardiovascular Sciences, Respiratory, Nephrological, Anaesthetics and Geriatrics, Policlinico Universitario Umberto I, Rome.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pavesi', 'Affiliation': 'Unit of Oncology, RCCS-Fondazione Salvatore Maugeri, Pavia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Iorno', 'Affiliation': 'Centre for Pain Medicine M. TIENGO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Crispino', 'Affiliation': 'UOSD Treatment of Lung Cancer Complications, AO Dei Colli Monaldi Cotugno CTO Ospedale Monaldi, Napoli.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pacchioni', 'Affiliation': 'Department of Oncology, Ospedale San Raffaele IRCCS, Milan.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Apolone', 'Affiliation': 'Scientific Direction, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw097']
3360,32027157,Trajectories of change in well-being during cognitive behavioral therapies for anxiety disorders: Quantifying the impact and covariation with improvements in anxiety.,"Cognitive behavioral therapy (CBT) has been found to be very effective in reducing many forms of mental illness, but much less is known about whether CBT also promotes mental health or well-being. The goals of the present study were to (a) quantify the magnitude and timing of changes in overall well-being and specific facets of well-being during different CBTs for anxiety disorders, (b) determine whether these effects vary across transdiagnostic and disorder-specific CBT, and (c) examine how changes in well-being during treatment relate to changes in anxiety. A total of 223 adults (55.6% female, Mage = 31.1 years) were randomized to 1 of 5 CBT protocols for anxiety disorders at an outpatient clinic. Analyses included standardized mean gain effect sizes (ESsg) and latent growth curve modeling. Moderate-to-large increases in overall well-being and the 3 components of subjective, psychological, and social well-being were observed, mainly during the second half of CBT, and these increases were maintained at a 6-month follow-up. The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition. Parallel process latent growth curve models indicated that trajectories of change in well-being across treatment were strongly correlated with trajectories of change in clinician-rated and self-reported anxiety. Together, these findings suggest that different CBT protocols for anxiety consistently produce robust and lasting changes in well-being, and these changes are strongly linked to changes in anxiety during treatment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition.,"['anxiety disorders', '223 adults (55.6% female, Mage = 31.1 years']","['cognitive behavioral therapies', 'CBT protocols', 'Cognitive behavioral therapy (CBT']","['standardized mean gain effect sizes (ESsg) and latent growth curve modeling', 'anxiety']","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",223.0,0.0152392,The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition.,"[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Richardson', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Long', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Department of Psychology, Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Department of Psychology, Boston University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000283']
3361,31927349,Vibration increases multifidus cross-sectional area versus cryotherapy added to chronic non-insertional Achilles tendinopathy eccentric exercise.,"OBJECTIVE


To assess multifidus muscle thickness, cross-sectional area (CSA) and disability in patients with chronic non-insertional Achilles tendinopathy (AT) who developed an eccentric exercise (EE) vibration program compared to an EE program with cryotherapy.
DESIGN


Single-blinded randomized clinical trial.
SETTING


Outpatient clinic.
PARTICIPANTS


A total sample of 61 patients diagnosed with chronic non-insertional AT was recruited and randomly divided into two groups. A group (n = 30) developed the EE program plus vibration and B group (n = 31) received the EE program plus cryotherapy for 12 weeks. Multifidus thickness and CSA were measured at rest and during maximal isometric contraction by ultrasound imaging. The Victorian Institute for Sport Assessment (VISA-A) was used to asses functionality.
RESULTS


Multifidus CSA was statistically significant increased (P < 0.05) for the EE vibration program group with respect to EE plus cryotherapy during maximal isometric contraction and at rest at 12-weeks after intervention in individuals with chronic non-insertional AT. Despite both interventions showed differences for the multifidus thickness and AT disability variables over time, there were not between-groups differences.
CONCLUSIONS


Authors encourage the use of vibration with respect to cryotherapy added to EE programs in order to enhance multifidus CSA in addition to lower limb functionality in individuals who suffer from chronic non-insertional AT.",2020,"RESULTS


Multifidus CSA was statistically significant increased (P < 0.05) for the EE vibration program group with respect to EE plus cryotherapy during maximal isometric contraction and at rest at 12-weeks after intervention in individuals with chronic non-insertional AT.","['individuals with chronic non-insertional AT', 'A total sample of 61 patients diagnosed with chronic non-insertional AT', 'patients with chronic non-insertional Achilles tendinopathy (AT) who developed an', 'individuals who suffer from chronic non-insertional AT', 'Outpatient clinic']","['EE program plus vibration', 'EE plus cryotherapy', 'eccentric exercise (EE) vibration program compared to an EE program with cryotherapy', 'EE program plus cryotherapy']","['multifidus muscle thickness, cross-sectional area (CSA) and disability', 'Multifidus thickness and CSA', 'multifidus thickness and AT disability variables']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3838916', 'cui_str': 'Non-insertional Achilles tendinopathy (disorder)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0224319', 'cui_str': 'Multifidus'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",61.0,0.0197503,"RESULTS


Multifidus CSA was statistically significant increased (P < 0.05) for the EE vibration program group with respect to EE plus cryotherapy during maximal isometric contraction and at rest at 12-weeks after intervention in individuals with chronic non-insertional AT.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain. Electronic address: carlos.romero@universidadeuropea.es.'}, {'ForeName': 'Pedro Javier', 'Initials': 'PJ', 'LastName': 'Martín-Llantino', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Calvo-Lobo', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Antolín-Gil', 'Affiliation': 'Department of Psychology, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'López-López', 'Affiliation': 'Research, Health and Podiatry Group. Department of Health Sciences; Faculty of Nursing and Podiatry, Universidade da Coruña, Ferrol, Spain. Electronic address: daniel.lopez.lopez@udc.es.'}, {'ForeName': 'María Benito-de', 'Initials': 'MB', 'LastName': 'Pedro', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Spain.'}, {'ForeName': 'David Rodríguez', 'Initials': 'DR', 'LastName': 'Sanz', 'Affiliation': 'School of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Spain.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.01.002']
3362,25122671,Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial.,"BACKGROUND


Masitinib is a highly selective tyrosine kinase inhibitor with activity against the main oncogenic drivers of gastrointestinal stromal tumor (GIST). Masitinib was evaluated in patients with advanced GIST after imatinib failure or intolerance.
PATIENTS AND METHODS


Prospective, multicenter, randomized, open-label trial. Patients with inoperable, advanced imatinib-resistant GIST were randomized (1 : 1) to receive masitinib (12 mg/kg/day) or sunitinib (50 mg/day 4-weeks-on/2-weeks-off) until progression, intolerance, or refusal. Primary efficacy analysis was noncomparative, testing whether masitinib attained a median progression-free survival (PFS) (blind centrally reviewed RECIST) threshold of >3 months according to the lower bound of the 90% unilateral confidence interval (CI). Secondary analyses on overall survival (OS) and PFS were comparative with results presented according to a two-sided 95% CI.
RESULTS


Forty-four patients were randomized to receive masitinib (n = 23) or sunitinib (n = 21). Median follow-up was 14 months. Patients receiving masitinib experienced less toxicity than those receiving sunitinib, with significantly lower occurrence of severe adverse events (52% versus 91%, respectively, P = 0.008). Median PFS (central RECIST) for the noncomparative primary analysis in the masitinib treatment arm was 3.71 months (90% CI 3.65). Secondary analyses showed that median OS was significantly longer for patients receiving masitinib followed by post-progression addition of sunitinib when compared against patients treated directly with sunitinib in second-line [hazard ratio (HR) = 0.27, 95% CI 0.09-0.85, P = 0.016]. This improvement was sustainable as evidenced by 26-month follow-up OS data (HR = 0.40, 95% CI 0.16-0.96, P = 0.033); an additional 12.4 months survival advantage being reported for the masitinib treatment arm. Risk of progression while under treatment with masitinib was in the same range as for sunitinib (HR = 1.1, 95% CI 0.6-2.2, P = 0.833).
CONCLUSIONS


Primary efficacy analysis ensured the masitinib treatment arm could satisfy a prespecified PFS threshold. Secondary efficacy analysis showed that masitinib followed by the standard of care generated a statistically significant survival benefit over standard of care. Encouraging median OS and safety data from this well-controlled and appropriately designed randomized trial indicate a positive benefit-risk ratio. Further development of masitinib in imatinib-resistant/intolerant patients with advanced GIST is warranted.",2014,Secondary efficacy analysis showed that masitinib followed by the standard of care generated a statistically significant survival benefit over standard of care.,"['Patients with inoperable, advanced imatinib-resistant GIST', 'advanced gastrointestinal stromal tumor (GIST) after failure of imatinib', 'patients with advanced GIST after imatinib failure or intolerance', 'Forty-four patients']","['masitinib', 'sunitinib']","['overall survival (OS) and PFS', 'median OS', 'toxicity', 'survival benefit', 'Risk of progression', 'median progression-free survival (PFS', 'Median PFS (central RECIST', 'severe adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal Stromal Tumors'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C2351398', 'cui_str': '4-((4-methylpiperazin-1-yl)methyl)-N-(4-methyl-3-((4-(pyridin-3-yl)-1,3-thiazol-2-yl)amino)phenyl)benzamide'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",44.0,0.274765,Secondary efficacy analysis showed that masitinib followed by the standard of care generated a statistically significant survival benefit over standard of care.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Adenis', 'Affiliation': 'Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard (CLB), Lyon.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bui-Nguyen', 'Affiliation': 'Department of Medicine, Institut Bergonié, Bordeaux.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, CHU Hôpital Robert Debré, Reims.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bertucci', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Isambert', 'Affiliation': 'Department of Oncology, Centre Georges François Leclerc, Dijon.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bompas', 'Affiliation': 'Department of Medical Oncology, Centre René Gauducheau, Saint Herblain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Chaigneau', 'Affiliation': 'Department of Medical Oncology, Hôpital Jean Minjoz, Besançon.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Domont', 'Affiliation': 'Department of Medicine, Institut Gustave Roussy (IGR), Villejuif, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Department of Medicine, Centre Léon Bérard (CLB), Lyon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blésius', 'Affiliation': 'Department of Medicine, Institut Gustave Roussy (IGR), Villejuif, France.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Van Tine', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Siteman Cancer Center, Washington University in St Louis, St Louis, USA.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Bulusu', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dubreuil', 'Affiliation': 'CRCM (Signaling, Hematopoiesis and Mechanism of Oncogenesis), INSERM U1068, Marseille; Institut Paoli-Calmettes, Aix-Marseille Université, Marseille; CNRS UMR7258, Marseille; AB Science, Paris.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Mansfield', 'Affiliation': 'AB Science, Paris.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Acin', 'Affiliation': 'AB Science, Paris.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moussy', 'Affiliation': 'AB Science, Paris.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'AB Science, Paris; Department of Hematology, Hôpital Necker, Paris; Department of Hematology, CNRS UMR 8147, Université Paris V René Descartes, Paris; Institut Imagine, Université Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Department of Medicine, Institut Gustave Roussy (IGR), Villejuif, France. Electronic address: axel.lecesne@gustaveroussy.fr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu237']
3363,26916095,A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study.,"BACKGROUND


Maintenance strategies beyond response or tumor stabilization with first-line chemotherapy in metastatic breast cancer (MBC) have not been extensively studied. Endocrine therapy combined with continued bevacizumab may be a helpful option for estrogen receptor (ER)-positive MBC.
PATIENTS AND METHODS


In this prospective, open-label, phase III study, patients with histologically confirmed ER-positive, HER2-negative MBC and non-progressive disease after 16-24 weeks of taxane plus bevacizumab (T + BEV) were randomized to continuation of T + BEV or maintenance bevacizumab plus exemestane (E + BEV). The primary end point was progression-free survival (PFS) from randomization. To have 80% power to detect an improvement in the 6-month PFS rate (PFS6m) from 50% to 65%, 186 assessable patients were needed for a total of 141 PFS events. An interim analysis was planned after 40% of the required events.
RESULTS


The interim analysis with 98 patients showed that the probability of reaching a statistically significant improvement in PFS by the end of the study was only 7%. This led the Independent Data and Monitoring Committee to recommend termination of patient enrollment. After a median of 21-month follow-up of all randomized patients (117 in total), PFS6m from randomization was 67.2% [95% confidence interval (CI) 53.6-77.7] with T + BEV and 55.2% (95% CI 41.5-66.9) with E + BEV [hazard ratio (HR): 1.0, 95% CI 0.7-1.5, P = 0.998]. Median PFS from BEV initiation was 12.5 and 12.3 months in the T + BEV and E + BEV arms, respectively. In the T + BEV arm, taxane was prematurely stopped for the majority of patients (94.9%), mainly due to toxicity (49.2%). Updated data after 35 months' median follow-up showed death rates of 44% and 55% in T + BEV and E + BEV arms, respectively.
CONCLUSION


In this trial, maintenance therapy with E + BEV in ER-positive, HER2-negative MBC patients with no evidence of progression after first-line T + BEV did not achieve longer PFS compared with continuation of T + BEV.
CLINICALTRIALSGOV


NCT01303679.",2016,"To have 80% power to detect an improvement in the 6-month PFS rate (PFS6m) from 50% to 65%, 186 assessable patients were needed for a total of 141 PFS events.","['patients with histologically confirmed ER-positive, HER2-negative MBC and non-progressive disease after 16-24 weeks of', 'patients with metastatic breast cancer after first-line', 'metastatic breast cancer (MBC']","['exemestane plus bevacizumab maintenance therapy', 'taxane plus bevacizumab (T + BEV', 'taxane and bevacizumab', 'Endocrine therapy combined with continued bevacizumab', 'taxane', 'T + BEV or maintenance bevacizumab plus exemestane (E + BEV']","['toxicity', 'death rates', 'Median PFS from BEV initiation', 'PFS', '6-month PFS rate (PFS6m', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3839460', 'cui_str': 'Non-progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",186.0,0.210222,"To have 80% power to detect an improvement in the 6-month PFS rate (PFS6m) from 50% to 65%, 186 assessable patients were needed for a total of 141 PFS events.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon; CNRS UMR5286, Cancer Research Center of Lyon, Lyon.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Follana', 'Affiliation': 'Department of Medical Oncology, Centre Antoine Lacassagne, Nice.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Moullet', 'Affiliation': 'Department of Medical Oncology, Clinique de la Sauvegarde, Lyon.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cropet', 'Affiliation': 'Direction of Clinical Research and Innovation, Centre Léon Bérard, Lyon.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Trager-Maury', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier de Senlis, Senlis.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'Department of Medical Oncology, Hôpital Mont-De-Marsan, Mont-De-Marsan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lavau-Denes', 'Affiliation': 'Department of Medical Oncology, CHU Dupuytren, Limoges.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Béal-Ardisson', 'Affiliation': 'Department of Medical Oncology, Hôpital Privé Jean Mermoz, Lyon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gouttebel', 'Affiliation': 'Department of Medical Oncology, Hôpitaux Drôme Nord, Site de Romans, Romans-sur-Isère.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Orfeuvre', 'Affiliation': 'Department of Medical Oncology, Hôpital Fleyriat, Bourg-en Bresse.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stefani', 'Affiliation': ""Department of Medical Oncology, Centre Hospitalier de la Région d'Annecy, Pringy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jouannaud', 'Affiliation': 'Department of Medical Oncology, Institut Jean Godinot, Reims.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bürki', 'Affiliation': ""Department of Medical Oncology, Clinique de l'Union, Saint-Jean.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Petit', 'Affiliation': 'Department of Medical Oncology, Centre Paul Strauss, Strasbourg.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guardiola', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier la Dracénie, Draguignan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Becuwe', 'Affiliation': ""Department of Medical Oncology, Oracle, Centre d'Oncologie de Gentilly, Nancy.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Blot', 'Affiliation': 'Department of Medical Oncology, Centre Hospitalier Bretagne Atlantique, Vannes.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu, Paris, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon; CNRS UMR5286, Cancer Research Center of Lyon, Lyon. Electronic address: thomas.bachelot@lyon.unicancer.fr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw077']
3364,26945010,A phase II/III randomized study to compare the efficacy and safety of rigosertib plus gemcitabine versus gemcitabine alone in patients with previously untreated metastatic pancreatic cancer.,,2016,,['patients with previously untreated metastatic pancreatic cancer'],"['rigosertib plus gemcitabine', 'gemcitabine alone']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C3467794'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0117398,,"[{'ForeName': 'B H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Aisner', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Menter', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Tejani', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granfortuna', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Coveler', 'Affiliation': ''}, {'ForeName': 'O O', 'Initials': 'OO', 'LastName': 'Olowokure', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Baranda', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cusnir', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Phillip', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boles', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nazemzadeh', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rarick', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bajaj', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bathini', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fanta', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berlin', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'McRee', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maguire', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wilhelm', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maniar', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jimeno', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Gomes', 'Affiliation': ''}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Messersmith', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw095']
3365,32026839,"Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial.","OBJECTIVE


To compare the effects of different cryotherapeutic preparations.
DESIGN


Randomised, single-blind, crossover trial.
SETTING


University laboratory.
PARTICIPANTS


Sixteen healthy women.
INTERVENTIONS


Participants were randomised to receive three cryotherapeutic preparations: pure ice (500g), watered ice (500g of ice in 500ml of water) and wetted ice (500g of ice in 50ml of water).
MAIN OUTCOME MEASURES


The primary outcome was skin surface temperature after cryotherapy, measured at the central point of application, and the minimum temperature of the region of interest (ROI). The secondary outcome was the surface area cooled to <13.6°C, which is the recommended temperature to achieve therapeutic effects.
RESULTS


After application of ice, mean skin surface temperature at the central point was 4.6 [standard deviation (SD) 1.9] °C for the pure ice preparation, 4.9 (SD 2.5) °C for the wetted ice preparation, and 9.6 (SD 1.8) °C for the watered ice preparation. When compared with the watered ice preparation, this represented a mean difference (MD) of 5.0°C for the pure ice preparation [95% confidence interval (CI) 4.0 to 6.0; P<0.001] and an MD of 4.7°C for the wetted ice preparation (95% CI 2.5 to 6.8; P<0.001). The minimum temperatures in the ROI were also lower for the pure ice preparation 3.0 (SD 0.9) °C and the wetted ice preparation 2.8 (SD 0.6) °C than the watered ice preparation 7.9 (SD 1.5) °C. This represented an MD of 4.8°C for the pure ice preparation (95% CI 4.0 to 5.7; P<0.001) and 5.1°C for the wetted ice preparation (95% CI 4.0 to 6.2; P<0.001].
CONCLUSIONS


Application of pure ice or wetted ice led to a greater decrease in skin surface temperature compared with watered ice. For clinical purposes, combining equal parts of water and ice could decrease this effect.
CLINICAL TRIAL REGISTRATION NUMBER


Clinicaltrials.gov (NCT03414346).",2020,"CONCLUSIONS


Application of pure ice or wetted ice led to a greater decrease in skin surface temperature compared with watered ice.","['University laboratory', 'Sixteen healthy women']","['cryotherapy', 'cryotherapeutic preparations: pure ice (500g), watered ice (500g of ice in 500ml of water) and wetted ice (500g of ice in 50ml of water']","['skin surface temperature after cryotherapy, measured at the central point of application, and the minimum temperature of the region of interest (ROI', 'skin surface temperature', 'mean skin surface temperature', 'therapeutic effects']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0349714', 'cui_str': 'Icing (substance)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1527144'}]",16.0,0.2698,"CONCLUSIONS


Application of pure ice or wetted ice led to a greater decrease in skin surface temperature compared with watered ice.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Estéfani', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ruschel', 'Affiliation': 'Health and Sports Science Centre, Santa Catarina State University, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Inaihá Laureano', 'Initials': 'IL', 'LastName': 'Benincá', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Daniela Pacheco', 'Initials': 'DP', 'LastName': 'Dos Santos Haupenthal', 'Affiliation': 'Laboratory of Cellular and Molecular Biology, University of the Extreme South of Santa Catarina, Criciuma, Santa Catarina, Brazil.'}, {'ForeName': 'Núbia Carelli Pereira', 'Initials': 'NCP', 'LastName': 'de Avelar', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Haupenthal', 'Affiliation': 'Aging, Resources and Rheumatology Laboratory, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil. Electronic address: alessandro.haupenthal@ufsc.br.'}]",Physiotherapy,['10.1016/j.physio.2019.12.005']
3366,26940686,Single-agent capecitabine as maintenance therapy after induction of XELOX (or FOLFOX) in first-line treatment of metastatic colorectal cancer: randomized clinical trial of efficacy and safety.,"BACKGROUND


The optimal strategy of maintenance therapy for patients with mCRC is controversial. This study was to evaluate the efficacy and safety of maintenance therapy with capecitabine versus observation following inductive chemotherapy in patients with metastatic colorectal cancer.
PATIENTS AND METHODS


In this randomized, open-label, multicenter, phase III trial, patients who received 18-24 weeks of induction chemotherapy with XELOX or FOLFOX and achieved disease control were randomly assigned centrally (1:1) to receive maintenance therapy of capecitabine or only observation until disease progression. The primary end point was progression-free survival (PFS) from randomization; the secondary end points included overall survival (OS), PFS from induction treatment (PFS2) and safety. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02027363.
RESULTS


Between 30 July 2010 and 15 September 2013, 274 patients were enrolled in the study from 11 sites in China and randomly assigned to maintenance group (n = 136) or observation group (n = 138). Clinicopathological characteristics were balanced in two groups. The median follow-up time from randomization was 29.0 months [interquartile range (IQR) 21-36 months]. The primary end point of PFS was statistically significantly longer in capecitabine maintenance group than in observation group {6.43 [95% confidence interval (CI) 5.26-7.71] versus 3.43 (2.83-4.16) months, HR 0.54 (0.42-0.70), P < 0.001}. The median OS of capecitabine maintenance group was longer than that of observation group, but not statistically significant [25.63 (22.46-27.80) versus 23.30 (19.68-26.92) months; HR 0.85 (0.64-1.11), P = 0.2247]. Similar safety profiles were observed in both arms. The most common grade 3 or 4 toxicities in capecitabine maintenance group versus observation group were neutropenia, hand-foot syndrome, and mucositis.
CONCLUSIONS


Maintenance therapy with a single agent of capecitabine can be considered an appropriate option following the induction of XELOX or FOLFOX in mCRC patients with acceptable toxicities.
CLINICAL TRIALS NUMBER


NCT02027363.",2016,"The most common grade 3 or 4 toxicities in capecitabine maintenance group versus observation group were neutropenia, hand-foot syndrome, and mucositis.
","['patients with metastatic colorectal cancer', 'patients with mCRC', 'patients who received 18-24 weeks of induction chemotherapy with XELOX or FOLFOX and achieved disease control', 'Between 30 July 2010 and 15 September 2013, 274 patients were enrolled in the study from 11 sites in China and randomly assigned to maintenance group (n = 136) or observation group (n = 138', 'metastatic colorectal cancer']","['capecitabine', 'maintenance therapy of capecitabine', 'inductive chemotherapy', 'XELOX (or FOLFOX', 'Single-agent capecitabine']","['median OS', 'efficacy and safety', 'PFS', 'neutropenia, hand-foot syndrome, and mucositis', 'progression-free survival (PFS', 'overall survival (OS), PFS from induction treatment (PFS2) and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",274.0,0.174123,"The most common grade 3 or 4 toxicities in capecitabine maintenance group versus observation group were neutropenia, hand-foot syndrome, and mucositis.
","[{'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Foshan, Guangzhou.""}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Huizhou Central Hospital, Huizhou.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, Guangdong General Hospital, Guangzhou.'}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Jiangmen Central Hospital, Jiangmen.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital of Shantou University Medical College, Shantou.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ""Department of Medical Oncology, Dongguan People's Hospital, Dongguan.""}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Tumor Hospital of Guangxi Medical University, Nanning.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Peng', 'Affiliation': ""Department of Medical Oncology, Zhongshan People's Hospital, Zhongshan, China.""}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou. Electronic address: xurh@sysucc.org.cn.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw101']
3367,26940688,Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial.,"BACKGROUND


The optimal regimen for adjuvant breast cancer chemotherapy is undefined. We compared sequential to concurrent combination of doxorubicin and cyclophosphamide with docetaxel chemotherapy in women with node-positive non-metastatic breast cancer. We report the final, 10-year analysis of disease-free survival (DFS), overall survival (OS), and long-term safety.
PATIENTS AND METHODS


A total of 3298 women with HER2 nonamplified breast cancer were randomized to doxorubicin and cyclophosphamide every 3 weeks for four cycles followed by docetaxel (AC → T) every 3 weeks for four cycles or docetaxel, doxorubicin, and cyclophosphamide (TAC) every 3 weeks for six cycles. The patients received standard radiotherapy and endocrine therapy and were followed up for 10 years with annual clinical evaluation and mammography.
RESULTS


The 10-year DFS rates were 66.5% in the AC → T arm and 66.3% in the TAC arm (P = 0.749). OS was 79.9% in the AC → T arm and 78.9% in the TAC arm (P = 0.506). TAC was associated with higher rates of febrile neutropenia, although G-CSF primary prophylaxis greatly reduced this risk. AC → T was associated with a higher rate of myalgia, hand-foot syndrome, fluid retention, and sensory neuropathy.
CONCLUSION


This 10-year analysis of the BCIRG-005 trial confirmed that the efficacy of TAC was not superior to AC → T in women with node-positive early breast cancer. The toxicity profiles differ between arms and were consistent with previous reports. The TAC regimen with G-CSF support provides shorter adjuvant treatment duration with less toxicity.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT00312208.",2016,OS was 79.9% in the AC → T arm and 78.9% in the TAC arm (P = 0.506).,"['women with node-positive early breast cancer', '3298 women with HER2 nonamplified breast cancer', 'node-positive breast cancer', 'women with node-positive non-metastatic breast cancer']","['docetaxel, doxorubicin, and cyclophosphamide (TAC', 'doxorubicin and cyclophosphamide with docetaxel chemotherapy', 'sequential versus combination docetaxel with doxorubicin and cyclophosphamide', 'TAC', 'doxorubicin and cyclophosphamide', 'standard radiotherapy and endocrine therapy']","['febrile neutropenia', '10-year DFS rates', 'disease-free survival (DFS), overall survival (OS), and long-term safety', 'rate of myalgia, hand-foot syndrome, fluid retention, and sensory neuropathy', 'OS', 'toxicity profiles']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention (disorder)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",3298.0,0.0766307,OS was 79.9% in the AC → T arm and 78.9% in the TAC arm (P = 0.506).,"[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Mackey', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Edmonton, Canada. Electronic address: john.mackey@trioncology.org.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pieńkowski', 'Affiliation': 'Department of Oncology, Postgraduate Medical Education Centre, Warsaw, Poland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Crown', 'Affiliation': 'All-Ireland Co-Operative Oncology Research Group, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Oncology, University of California, Los Angeles, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Department of Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre, WA & Curtin University, Perth, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Saleh', 'Affiliation': 'Department of Oncology, University of Alabama Comprehensive Cancer Center, Birmingham, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sehdev', 'Affiliation': 'Department of Oncology, William Osler Health Center, Brampton Civic Hospital, Brampton.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'Department of Oncology, CHU de Québec/Université Laval, Québec, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Semiglazov', 'Affiliation': 'Department of Oncology, Research Institute of Oncology N.N. Petrov Rosmedtechnologiy, St Petersburg, Russian Federation.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Press', 'Affiliation': 'Department of Pathology, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sauter', 'Affiliation': 'Department of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'Translational Research in Oncology, Edmonton, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Houé', 'Affiliation': 'Translational Research in Oncology, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': 'Biostatistics, International Drug Development Institute Statistics, Leuven, Belgium.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Drevot', 'Affiliation': 'Translational Research in Oncology, Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hitier', 'Affiliation': 'Clinical Studies, Sanofi, Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bensfia', 'Affiliation': 'Clinical Studies, Sanofi, Paris, France.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Gynecology and Obstetrics, Isarklinikum & IOZ, Munich, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw098']
3368,26912556,Reply to the letter to the editor 'A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma' by Hines et al.,,2016,,"[""patients with resected Dukes B2-C colorectal carcinoma' by Hines et al""]",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009402', 'cui_str': 'Colorectal Carcinoma'}]",[],[],,0.0252657,,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Department of Oncology, Ospedale San Carlo, Potenza.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mosconi', 'Affiliation': 'Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Apolone', 'Affiliation': 'Department of Oncology, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Johnson', 'Affiliation': 'Department of Surgery, St Louis University Hospital, St Louis, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan. Electronic address: roldano.fossati@marionegri.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdw076']
3369,32025883,Influence of ozone application in the stepwise excavation of primary molars: a randomized clinical trial.,"OBJECTIVES


The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to investigate the clinical and microbiological effects of the ozone application in stepwise excavation of primary molars.
MATERIALS AND METHODS


This study was conducted in in vivo conditions with 105 lower primary molars that had deep caries lesions. The teeth were randomly divided into three groups: (I) control group, conventional stepwise excavation with no disinfectants; (II) CHX (positive control) group, 2% chlorhexidine digluconate; and (III) experimental group, ozone application. Dentine samples were collected at 4 different time points (T0, at the first appointment, after partial removal of carious dentin; T1, at the first appointment, after applying disinfection procedure; T2, at the second appointment - at the end of the 4-month period - immediately after the removal of the temporary restoration; T3, at the second appointment, after the final excavation) for the microbiological analysis of mutans streptococci and lactobacilli and the total number of colony-forming units. Clinical changes including dentin color, humidity, and consistency were recorded. Data were analyzed using the Mann-Whitney U test, Friedman test, and chi-squared test (p = 0.05).
RESULTS


The dentin became harder and drier after 4 months in all the groups. There was a gradual reduction in the total number of microorganisms in all the three groups. Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
CONCLUSION


Stepwise excavation of primary teeth provided successful outcomes in all the groups. Moreover, CHX, due to its practicality and cost-effectiveness, can be effectively used with one- or two-step indirect pulp therapies.
CLINICAL RELEVANCE


Usage of cavity disinfectants in the stepwise excavation procedure contributes to the reduction of bacterial population in the cavity, which may allow the avoidance of the second step of the indirect pulp therapy for primary teeth.",2020,"Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
","['105 lower primary molars that had deep caries lesions', 'primary molars']","['ozone application', 'CHX', 'control group, conventional stepwise excavation with no disinfectants; (II) CHX (positive control) group, 2% chlorhexidine digluconate; and (III) experimental group, ozone application']","['Bacterial reduction', 'total number of microorganisms', 'dentin color, humidity, and consistency']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333523', 'cui_str': 'Deep caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",105.0,0.0300688,"Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
","[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Mese', 'Affiliation': 'Department of Pedodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Yesim Tuyji', 'Initials': 'YT', 'LastName': 'Tok', 'Affiliation': 'Department of Medical Microbiology, Atatürk Training and Research Hospital, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Kaya', 'Affiliation': 'Department of Medical Microbiology, Atatürk Training and Research Hospital, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akcay', 'Affiliation': 'Department of Pedodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey. merve.akcay@ikc.edu.tr.'}]",Clinical oral investigations,['10.1007/s00784-020-03223-6']
3370,21896539,Capecitabine versus 5-fluorouracil/folinic acid as adjuvant therapy for stage III colon cancer: final results from the X-ACT trial with analysis by age and preliminary evidence of a pharmacodynamic marker of efficacy.,"BACKGROUND


This multicenter randomized trial compared oral capecitabine with bolus i.v. 5-fluorouracil (5-FU)/folinic acid (FA) as adjuvant therapy for stage III colon cancer.
PATIENTS AND METHODS


Patients were assigned to 24 weeks of capecitabine 1250 mg/m(2) twice daily on days 1-14 every 3 weeks or 5-FU/FA (Mayo Clinic regimen). The primary end point was disease-free survival (DFS).
RESULTS


The intent-to-treat population received capecitabine (n = 1004) or 5-FU/FA (n = 983). With a median follow-up of 6.9 years, capecitabine was at least equivalent to 5-FU/FA in terms of DFS [hazard ratio (HR) = 0.88; 95% confidence interval (CI) 0.77-1.01] and overall survival (OS) (HR = 0.86; 95% CI 0.74-1.01); the 95% CI upper limits were significantly less than the predefined noninferiority margins of 1.20 (P < 0.0001) and 1.14 (P < 0.001), respectively. This pattern was maintained in all subgroups, including patients aged ≥ 70 years. Preplanned multivariate analyses showed that capecitabine had statistically significant beneficial effects on DFS (P = 0.021) and OS (P = 0.020) versus 5-FU/FA. A post hoc analysis suggested that the occurrence of hand-foot syndrome may be associated with better outcomes in capecitabine recipients.
CONCLUSION


Oral capecitabine is an effective alternative to bolus 5-FU/FA as adjuvant treatment of patients with stage III colon cancer with efficacy benefits maintained at 5 years and in older patients.",2012,Preplanned multivariate analyses showed that capecitabine had statistically significant beneficial effects on DFS (P = 0.021) and OS (P = 0.020) versus 5-FU/FA.,"['Patients were assigned to 24 weeks of', 'patients aged ≥ 70 years', 'stage III colon cancer', 'patients with stage III colon cancer']","['capecitabine', '5-fluorouracil', '5-FU/FA', 'Capecitabine versus 5-fluorouracil/folinic acid', '5-FU)/folinic acid (FA', 'oral capecitabine', 'capecitabine 1250 mg/m(2) twice daily on days 1-14 every 3 weeks or 5-FU/FA']","['DFS', 'overall survival (OS', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.209506,Preplanned multivariate analyses showed that capecitabine had statistically significant beneficial effects on DFS (P = 0.021) and OS (P = 0.020) versus 5-FU/FA.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': ""University of Leeds and St James's Institute of Oncology Hospital, Leeds Cancer Research UK Centre, Leeds, UK. Electronic address: c.j.twelves@leeds.ac.uk.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McKendrick', 'Affiliation': 'Department of Haematology and Medical Oncology, Box Hill Hospital, Melbourne, Australia.'}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': 'Digestive Oncology Unit, Hôpital La Timone, Université de la Méditerranée, Marseille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Van Hazel', 'Affiliation': 'Perth Oncology, Mount Medical Centre, Perth, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Díaz-Rubio', 'Affiliation': 'Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gilberg', 'Affiliation': 'F. Hoffmann-La Roche Inc., Basel, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'Department of Medical Oncology, University of Glasgow, Glasgow, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr366']
3371,21372124,"A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer.","BACKGROUND


Sagopilone, the first fully synthetic epothilone, has shown promising preclinical activity in tumour models. This open-label randomised phase II study investigated two infusion schedules of sagopilone in women with ovarian cancer.
PATIENTS AND METHODS


Women with ovarian cancer recurring within 6 months of end of last platinum-containing treatment received sagopilone 16 mg/m(2) as a 3- or 0.5-h i.v. infusion every 21 days for up to 6 weeks.
RESULTS


Sixty-three patients received sagopilone as a 3-h (n=38) or 0.5-h (n=25) infusion. There were nine confirmed tumour responses [by modified RECIST (n=8) and by Gynecologic Cancer Intergroup CA-125 criteria (n=1)] in 57 patients assessable for efficacy overall [three (13%) with 0.5-h and six (18%) with 3-h infusions]. The 0.5-h arm was closed when it failed to meet its target efficacy. Main drug-related adverse events were peripheral sensory neuropathy (73%; 16% grade 3), nausea (37%; 2% grade 3), fatigue (35%; 3% grade 3) and arthralgia (30%; 5% grade 3). Overall incidence of peripheral sensory neuropathy was similar in both treatment arms, with no grade 4 neuropathy events. No acute allergic infusion reactions were observed.
CONCLUSION


Sagopilone is effective, with balanced tolerability, in patients with recurrent platinum-resistant ovarian cancer.",2011,"Overall incidence of peripheral sensory neuropathy was similar in both treatment arms, with no grade 4 neuropathy events.","['women with ovarian cancer', 'Women with ovarian cancer recurring within 6 months of end of last platinum-containing treatment received', 'patients with platinum-resistant ovarian cancer', 'patients with recurrent platinum-resistant ovarian cancer', 'Sixty-three patients received sagopilone as a 3-h (n=38) or 0.5-h (n=25) infusion']","['sagopilone (ZK-EPO', 'sagopilone', 'sagopilone 16 mg/m(2']","['Overall incidence of peripheral sensory neuropathy', 'nausea', 'peripheral sensory neuropathy', 'arthralgia', 'acute allergic infusion reactions', 'fatigue']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C2355512', 'cui_str': '4,17-Dioxabicyclo(14.1.0)heptadecane-5,9-dione, 7,11-dihydroxy-8,8,12,16-tetramethyl-3-(2-methyl-5-benzothiazolyl)-10-(2-propen-1-yl)-, (1S,3S,7S,10R,11S,12S,16R)-'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C2355512', 'cui_str': '4,17-Dioxabicyclo(14.1.0)heptadecane-5,9-dione, 7,11-dihydroxy-8,8,12,16-tetramethyl-3-(2-methyl-5-benzothiazolyl)-10-(2-propen-1-yl)-, (1S,3S,7S,10R,11S,12S,16R)-'}, {'cui': 'C2936926', 'cui_str': 'ZK-EPO'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0616899,"Overall incidence of peripheral sensory neuropathy was similar in both treatment arms, with no grade 4 neuropathy events.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rustin', 'Affiliation': 'Medical Oncology, Mount Vernon Cancer Centre, Northwood. Electronic address: grustin@nhs.net.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Department of Clinical Oncology, Beatson Oncology Centre, Gartnavel General Hospital, Glasgow.'}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'School of Cancer and Enabling Sciences, University of Manchester and Christie Hospital, Manchester.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Department of Oncology, UCL Hospitals and UCL Cancer Institute, London.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Adams', 'Affiliation': 'Clinical Oncology, Velindre NHS Trust, Cardiff.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': ""Department of Medical Oncology, St James's Institute of Oncology, St James's University Hospital, Leeds.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Arden Cancer Research Centre, University Hospitals Coventry and Warwickshire, Coventry.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Oncology, Princess Royal Hospital, Hull.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Persic', 'Affiliation': 'Clinical Oncology, Derbyshire Royal Infirmary, Derby.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Essapen', 'Affiliation': 'Clinical Oncology, The Royal Surrey County Hospital, Guildford.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': 'Gynaecology Unit, The Royal Marsden NHS Foundation Trust, London.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Calvert', 'Affiliation': 'UCL Cancer Institute, London.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stredder', 'Affiliation': 'Bayer plc, Newbury, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': 'Global Medical Development Oncology, Bayer Schering Pharma AG, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giurescu', 'Affiliation': 'Global Medical Development Oncology, Bayer Schering Pharma AG, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kaye', 'Affiliation': 'Gynaecology Unit, The Royal Marsden NHS Foundation Trust, London.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq780']
3372,21896540,Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial.,"BACKGROUND


Paclitaxel embedded in cationic liposomes (EndoTAG™-1; ET) is an innovative agent targeting tumor endothelial cells. This randomized controlled phase II trial evaluated the safety and efficacy of ET in combination with gemcitabine (GEM) in advanced pancreatic cancer (PDAC).
PATIENTS AND METHODS


Chemotherapy-naive patients with locally advanced or metastatic disease were randomly assigned to receive weekly GEM 1000 mg/m(2) or GEM plus twice-weekly ET 11, 22 or 44 mg/m(2) for 7 weeks. After a safety run-in of 100 patients, a second cohort continued treatment. End points included overall survival (OS), progression-free survival (PFS), tumor response and safety.
RESULTS


Two hundred and twelve patients were randomly allocated to the study and 200 were treated (80% metastatic, 20% locally advanced). Adverse events were manageable and reversible. Transient thrombocytopenia and infusion reactions with chills and pyrexia mostly grade 1 or 2 occurred in the ET groups. Disease control rate after the first treatment cycle was 43% with GEM and 60%, 65% and 52% in the GEM + ET cohorts. Median PFS reached 2.7 compared with 4.1, 4.6 and 4.4 months, respectively. Median OS was 6.8 compared with 8.1, 8.7 and 9.3 months, respectively.
CONCLUSIONS


Treatment of advanced PDAC with GEM + ET was generally well tolerated. GEM + ET showed beneficial survival and efficacy. A randomized phase III trial should confirm this positive trend.",2012,"Disease control rate after the first treatment cycle was 43% with GEM and 60%, 65% and 52% in the GEM + ET cohorts.","['Chemotherapy-naive patients with locally advanced or metastatic disease', 'advanced pancreatic cancer (PDAC', '100 patients', 'patients with advanced pancreatic cancer', 'Two hundred and twelve patients were randomly allocated to the study and 200 were treated (80% metastatic, 20% locally advanced']","['GEM + ET', 'ET', 'Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone', 'gemcitabine (GEM', 'GEM 1000 mg/m(2) or GEM plus twice-weekly ET']","['Disease control rate', 'Adverse events', 'tolerated', 'Median PFS', 'safety and efficacy', 'Median OS', 'Transient thrombocytopenia and infusion reactions', 'beneficial survival and efficacy', 'overall survival (OS), progression-free survival (PFS), tumor response and safety']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0445501', 'cui_str': 'Gem (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction caused by drug or medicament administered by infusion'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",212.0,0.0838642,"Disease control rate after the first treatment cycle was 43% with GEM and 60%, 65% and 52% in the GEM + ET cohorts.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Löhr', 'Affiliation': 'Department of Medicine II, University Hospital Mannheim, Mannheim, Germany; Department of Surgical Gastroenterology, Karolinska Institutet, Stockholm, Sweden. Electronic address: matthias.lohr@ki.se.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine II, University Hospital Mannheim, Mannheim, Germany; Department of Surgical Gastroenterology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'W-O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Department of General and Visceral Surgery, University Hospital Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bodoky', 'Affiliation': 'Department of Oncology, Szent Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cwiertka', 'Affiliation': 'Department of Oncology, University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fischbach', 'Affiliation': 'Department of Medicine II, Klinikum Aschaffenburg, Aschaffenburg.'}, {'ForeName': 'U R', 'Initials': 'UR', 'LastName': 'Fölsch', 'Affiliation': 'Department of General Internal Medicine, University Hospital Schleswig-Holstein, Kiel.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jäger', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Osinsky', 'Affiliation': 'Institute of Oncology AMS of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Prausova', 'Affiliation': 'Department of Oncological Radiotherapy, University Hospital Prague, Prague, Czech Republic.'}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Schmidt', 'Affiliation': 'Department of Medicine I, St. Josef-Hospital, Ruhr-University, Bochum.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Lutz', 'Affiliation': 'Department of Medicine, Caritasklinik St. Theresia, Saarbrücken, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr379']
3373,21930686,An intra-patient placebo-controlled phase I trial to evaluate the safety and tolerability of intradermal IMM-101 in melanoma.,"BACKGROUND


IMM-101 is a heat-killed innate and adaptive immune-activating mycobacterial product; a phase I study aimed to determine its safety and tolerability in individuals with melanoma.
PATIENTS AND METHODS


An intra-patient placebo-controlled study evaluated the safety and tolerability of three doses, namely, 0.1 (1 mg/ml), 0.5 (5 mg/ml) and 1.0 mg (10 mg/ml) of IMM-101 in stage III or IV melanoma. Each dose was administered in ascending order to one of the three cohorts.
RESULTS


Based on observations from patients administered the 0.1-mg dose, it was considered appropriate to proceed with dosing the patients in the 0.5-mg dose cohort and then the 1.0-mg cohort (n = 6 per cohort). Treatment-emergent adverse events that would be considered typical of a post-vaccination state (including joint pains/aches, headaches and influenza-like symptoms) occurred at all dose levels, along with injection site reactions. These were mainly mild in intensity, resolved in a matter of days and responded well to supportive care. During post-study follow-up, two clinical responses (15%) were observed in patients with stage IV disease.
CONCLUSION


IMM-101 is safe and well tolerated and there is a rationale for studying IMM-101 at a nominal 1.0-mg dose to complement conventional cytotoxic therapy for patients with advanced cancer.",2012,"During post-study follow-up, two clinical responses (15%) were observed in patients with stage IV disease.
","['patients with stage IV disease', 'patients with advanced cancer', 'melanoma', 'individuals with melanoma']","['intradermal IMM-101', 'IMM-101']","['safe and well tolerated', 'joint pains/aches, headaches and influenza-like symptoms', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C3501154', 'cui_str': 'IMM-101'}]","[{'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0234238', 'cui_str': 'Ache'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.222911,"During post-study follow-up, two clinical responses (15%) were observed in patients with stage IV disease.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stebbing', 'Affiliation': 'Department of Oncology, Imperial College and Imperial College Healthcare NHS Trust, London. Electronic address: j.stebbing@imperial.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dalgleish', 'Affiliation': ""Department of Oncology, St George's University of London, London.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gifford-Moore', 'Affiliation': 'HCA International, London.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'HCA International, London.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gleeson', 'Affiliation': 'Immodulon Therapeutics Limited, London.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Immodulon Therapeutics Limited, London.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Brunet', 'Affiliation': 'Immodulon Therapeutics Limited, London.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Grange', 'Affiliation': 'Immodulon Therapeutics Limited, London.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mudan', 'Affiliation': ""Immodulon Therapeutics Limited, London; Department of Surgery, St George's University of London, London, UK.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr363']
3374,21937705,A multicenter randomized phase III trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer.,"BACKGROUND


The Breast Cancer Study Group of the Hellenic Oncology Research Group conducted a phase III trial of single-agent capecitabine versus the vinorelbine/gemcitabine doublet in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. The primary objective was to demonstrate superiority of combination treatment in terms of progression-free survival (PFS).
PATIENTS AND METHODS


Women with MBC were randomly assigned to receive either capecitabine (Cap arm: 1250 mg/m(2) twice daily, on days 1-14) or vinorelbine/gemcitabine doublet (VG arm: vinorelbine 25 mg/m(2); gemcitabine 1000 mg/m(2); both drugs on days 1 and 15).
RESULTS


Seventy-four women were treated on each arm and median PFS was 5.4 versus 5.2 months (P = 0.736), for VG and Cap, respectively. Median overall survival was 20.4 months for the VG arm and 22.4 months for the Cap arm (P = 0.319). Overall response rate was 28.4% in the VG arm and 24.3% in the Cap arm (P = 0.576). Both regimens were generally well tolerated. Neutropenia and fatigue were more common with VG arm and hand-foot syndrome with Cap arm.
CONCLUSIONS


This trial failed to demonstrate superiority of vinorelbine/gemcitabine doublet over single-agent capecitabine in terms of PFS. Given the favorable toxicity and convenience of oral administration, single-agent capecitabine is recommended for compliant patients.",2012,Overall response rate was 28.4% in the VG arm and 24.3% in the Cap arm (P = 0.576).,"['Women with MBC', 'compliant patients', 'anthracycline- and taxane-pretreated women with metastatic breast cancer', 'patients with metastatic breast cancer (MBC) pretreated with']","['capecitabine', 'vinorelbine/gemcitabine', 'vinorelbine/gemcitabine doublet', 'single-agent capecitabine', 'anthracyclines and taxanes', 'vinorelbine/gemcitabine doublet (VG arm: vinorelbine 25 mg/m(2); gemcitabine', 'vinorelbine/gemcitabine doublet versus capecitabine monotherapy']","['Overall response rate', 'median PFS', 'tolerated', 'Neutropenia and fatigue', 'Median overall survival', 'progression-free survival (PFS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",74.0,0.0636895,Overall response rate was 28.4% in the VG arm and 24.3% in the Cap arm (P = 0.576).,"[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Pallis', 'Affiliation': 'Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Boukovinas', 'Affiliation': 'Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ardavanis', 'Affiliation': 'Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Varthalitis', 'Affiliation': 'Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Malamos', 'Affiliation': 'Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mavroudis', 'Affiliation': 'Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece. Electronic address: mavrudis@med.uoc.gr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr405']
3375,21464158,A cytokine and angiogenic factor (CAF) analysis in plasma for selection of sorafenib therapy in patients with metastatic renal cell carcinoma.,"BACKGROUND


We investigated cytokines and angiogenic factors (CAFs) in patients with metastatic renal cell carcinoma (mRCC) treated in a randomized phase II clinical trial of sorafenib versus sorafenib+ interferon-α (IFN-α) that yielded no differences in progression-free survival (PFS). We aimed to link the CAF profile to PFS and select candidate predictive and prognostic markers for further study.
METHODS


The concentrations of 52 plasma CAFs were measured pretreatment (n = 69), day 28, and day 56 using multiplex bead arrays and enzyme-linked immunosorbent assay. We investigated the association between baseline levels of CAFs with PFS and posttreatment changes.
RESULTS


Unsupervised CAF clustering analysis revealed two distinct mRCC patient groups with elevated proangiogenic or proinflammatory mediators. A six-marker baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand] correlated with PFS benefit (hazard ratio 0.20 versus 2.25, signature negative versus positive, respectively; P = 0.0002). While changes in angiogenic factors were frequently attenuated by the sorafenib+ IFN combination, most key immunomodulatory mediators increased.
CONCLUSIONS


Using CAF profiling, we identified two mRCC patient groups, a candidate plasma signature for predicting PFS benefit, and distinct marker changes occurring with each treatment. This platform may provide valuable insights into renal cell carcinoma biology and the molecular consequences of targeted therapies.",2012,"A six-marker baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand] correlated with PFS benefit (hazard ratio 0.20 versus 2.25, signature negative versus positive, respectively; P = 0.0002).","['patients with metastatic renal cell carcinoma', 'patients with metastatic renal cell carcinoma (mRCC']","['sorafenib therapy', 'sorafenib versus sorafenib+ interferon-α (IFN-α']","['baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand', 'angiogenic factors', 'elevated proangiogenic or proinflammatory mediators', 'progression-free survival (PFS', 'concentrations of 52 plasma CAFs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C4255077', 'cui_str': 'CAIX Protein'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0002976', 'cui_str': 'Angiogenesis Factor'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",69.0,0.114691,"A six-marker baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand] correlated with PFS benefit (hazard ratio 0.20 versus 2.25, signature negative versus positive, respectively; P = 0.0002).","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Departments of Genitourinary Medical Oncology. Electronic address: azurita@mdanderson.org.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jonasch', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khajavi', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'D Z', 'Initials': 'DZ', 'LastName': 'Du', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Herynk', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'McKee', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Tran', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr047']
3376,21948812,Acupuncture compared with placebo acupuncture in radiotherapy-induced nausea--a randomized controlled study.,"BACKGROUND


It is not known if verum (real) acupuncture is effective for nausea and vomiting (emesis) during radiotherapy.
PATIENTS AND METHODS


We randomly treated 215 blinded cancer patients with verum: penetrating 'deqi' creating acupuncture (n = 109) or non-penetrating sham needles (n = 106) two to three times per week. The patients documented emesis daily during the radiotherapy period. Primary end point was the number of patients with at least one episode of nausea.
RESULTS


In the verum and the sham acupuncture group, 70% and 62% experienced nausea at least once during the radiotherapy period (relative risk 1.1, 95% CI 0.9-1.4) for a mean number of 10.1 and 8.7 days. Twenty five percent and 28% vomited, and 42% and 37% used antiemetic drugs at least once, respectively. Ninety-five percent in the verum acupuncture group and 96% in the sham acupuncture group believed that the treatment had been effective against nausea. In both groups, 67% experienced positive effects on relaxation, mood, sleep or pain reduction and 89% wished to receive the treatment again.
CONCLUSION


Acupuncture creating deqi is not more effective than sham in radiotherapy-induced nausea, but in this study, nearly all patients in both groups experienced that the treatment was effective for nausea.",2012,Ninety-five percent in the verum acupuncture group and 96% in the sham acupuncture group believed that the treatment had been effective against nausea.,['We randomly treated 215 blinded cancer patients with'],"[""verum: penetrating 'deqi' creating acupuncture (n = 109) or non-penetrating sham needles"", 'Acupuncture', 'sham acupuncture', 'verum acupuncture', 'placebo acupuncture', 'verum (real) acupuncture']","['number of patients with at least one episode of nausea', 'effective against nausea', 'nausea', 'relaxation, mood, sleep or pain reduction', 'nausea and vomiting (emesis']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",215.0,0.389323,Ninety-five percent in the verum acupuncture group and 96% in the sham acupuncture group believed that the treatment had been effective against nausea.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Enblom', 'Affiliation': 'Division of Nursing Science, Department of Medical and Health Sciences, Linköping University, Linköping; The Swedish Institute for Health Sciences, Lund University, Lund; Department of Clinical Neuroscience, Osher Centre for Integrative Medicine, Karolinska Institute, Stockholm. Electronic address: anna.enblom@ki.se.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Johnsson', 'Affiliation': 'Department of Oncology, University Hospital, Lund.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hammar', 'Affiliation': 'Obstetrics and Gynecology, Department of Clinical and Experimental Medicine, Linköping University, Linköping.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Onelöv', 'Affiliation': 'Division of Clinical Cancer Epidemiology, Department of Oncology-Pathology, Karolinska Institute, Stockholm.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Steineck', 'Affiliation': 'Division of Clinical Cancer Epidemiology, Department of Oncology-Pathology, Karolinska Institute, Stockholm; Division of Clinical Cancer Epidemiology, Department of Oncology, Sahlgrenska Academy, Gothenburg.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Börjeson', 'Affiliation': 'Division of Nursing Science, Department of Medical and Health Sciences, Linköping University, Linköping; Centre of Surgery and Oncology, Department of Oncology, Linköping University Hospital, Linköping, Sweden.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr402']
3377,21965475,A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study.,"BACKGROUND


The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer.
PATIENTS AND METHODS


Patients were randomly assigned to EC (E 120 mg/m(2), C 600 mg/m(2), arm A) for four cycles or four cycles of D (100 mg/m(2)) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety.
RESULTS


There were 750 patients enrolled. With a median follow-up of 64 months, 5-year DFS was 73.4% in both arms, and 5-year OS was 89.5% versus 90.7% in arm A and B [hazard ratio was 0.99 (95% confidence interval for DFS 0.75-1.31; P = 0.95)], respectively. Grade 3-4 toxicity was more common in arm B.
CONCLUSIONS


This study did not show advantages from the addition of docetaxel to high-dose EC as adjuvant chemotherapy in node-positive breast cancer. The small sample size and low number of DFS events may have limited the ability to observe statistically significant difference between the two arms.",2012,Grade 3-4 toxicity was more common in arm,"['750 patients enrolled', 'Patients', 'node-positive breast cancer']","['EC', 'Hormone receptor-positive patients were given hormonal therapy', 'epirubicin', 'epirubicin plus cyclophosphamide (EC', 'cyclophosphamide (EC) versus docetaxel', 'docetaxel (Taxotere, D', 'docetaxel']","['5-year disease-free survival (DFS', 'overall survival (OS) and safety', '5-year OS', '5-year DFS', 'Grade 3-4 toxicity']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}]","[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0699967', 'cui_str': 'Taxotere'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",750.0,0.343865,Grade 3-4 toxicity was more common in arm,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vici', 'Affiliation': 'Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome. Electronic address: pvici@ifo.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brandi', 'Affiliation': 'Division of Medical Oncology, Oncologic Institute, Bari; Breast Surgery Unit, Oncologic Institute, Bari; Oncologic Unit, Dimiccoli Hospital, Barletta.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Division of Medical Oncology, Oncologic Institute, Bari.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Foggi', 'Affiliation': 'Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Schittulli', 'Affiliation': 'Breast Surgery Unit, Oncologic Institute, Bari.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Lauro', 'Affiliation': 'Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gebbia', 'Affiliation': 'Division of Medical Oncology, Department of Surgery and Oncology, University of Palermo, Palermo.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massidda', 'Affiliation': 'Division of Medical Oncology, Medicine and Surgery, University of Cagliari, Cagliari.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Filippelli', 'Affiliation': 'Division of Medical Oncology, S. Francesco Hospital, Paola.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Giannarelli', 'Affiliation': 'Department of Statistics.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Benedetto', 'Affiliation': 'Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mottolese', 'Affiliation': 'Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Division of Medical Oncology, Oncologic Institute, Bari.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lopez', 'Affiliation': 'Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr412']
3378,21402619,Ovarian cancer in elderly patients: carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in late relapse: a Gynecologic Cancer Intergroup (GCIG) CALYPSO sub-study.,"BACKGROUND


CALYPSO (CAeLYx in Platinum Sensitive Ovarian) patients compared carboplatin-pegylated liposomal doxorubicin (C-PLD) with carboplatin-paclitaxel (C-P) in patients with late-relapsing recurrent ovarian cancer (ROC). We analyzed outcomes in patients ≥70 years.
PATIENTS AND METHODS


Nine hundred and seventy-six patients with taxane-pretreated ROC relapsing >6 months after first- or second-line platinum-based therapy were randomly assigned to 4-weekly C area under the curve (AUC) 5 plus PLD 30 mg/m(2) or 3-weekly C AUC 5 plus P 175 mg/m(2) for six or more cycles.
RESULTS


One hundred and fifty-seven (16%) patients ≥70 years (median: 74 years, C-PLD; 73 years, C-P; range 70-82 years) were included (n = 71, C-PLD; n = 86, C-P). In comparing elderly and younger, elderly patients experienced fewer grade ≥2 allergic reactions (P = 0.005) but more grade ≥2 sensory neuropathy (P = 0.007). Myelosuppression did not differ with age. Elderly patients completed planned treatment as frequently as younger (79%, C-PLD; 82%, C-P). In comparing arms within elderly patients, C-P was associated with more grade ≥2 alopecia, sensory neuropathy, arthralgia/myalgia (P < 0.001 for all), severe leukopenia plus febrile neutropenia; C-PLD was associated with more grade ≥2 hand-foot syndrome (P = 0.005). Median progression-free survival was 11.6 months (C-PLD) and 10.3 months (C-P; P = 0.44).
CONCLUSIONS


Patients ≥70 years experienced more neuropathy, with a higher incidence in the C-P arm. Similar to all study patients, C-PLD provided a better therapeutic index with less toxicity than C-P in elderly women with platinum-sensitive ROC.",2011,"In comparing elderly and younger, elderly patients experienced fewer grade ≥2 allergic reactions (P = 0.005) but more grade ≥2 sensory neuropathy (P = 0.007).","['patients ≥70 years', 'patients with late-relapsing recurrent ovarian cancer (ROC', 'late relapse: a Gynecologic Cancer Intergroup (GCIG', 'Ovarian cancer in elderly patients', 'One hundred and fifty-seven (16%) patients ≥70 years (median: 74 years, C-PLD', 'Nine hundred and seventy-six patients with taxane-pretreated ROC relapsing >6 months after first- or second-line platinum-based therapy', 'elderly women with platinum-sensitive ROC']","['4-weekly C area under the curve (AUC) 5 plus PLD 30 mg/m(2) or 3-weekly C AUC 5 plus P 175 mg/m(2) for six or more cycles', 'carboplatin-pegylated liposomal doxorubicin (C-PLD) with carboplatin-paclitaxel (C-P', 'CALYPSO (CAeLYx', 'carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel']","['toxicity', 'grade ≥2 allergic reactions', 'Myelosuppression', 'grade ≥2 sensory neuropathy', 'grade ≥2 alopecia, sensory neuropathy, arthralgia/myalgia', 'Median progression-free survival', 'severe leukopenia plus febrile neutropenia; C-PLD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0962702', 'cui_str': 'calypso'}, {'cui': 'C0701183', 'cui_str': 'Caelyx'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}]",976.0,0.0643723,"In comparing elderly and younger, elderly patients experienced fewer grade ≥2 allergic reactions (P = 0.005) but more grade ≥2 sensory neuropathy (P = 0.007).","[{'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Kurtz', 'Affiliation': 'Department of Hematology and Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg. Electronic address: j-emmanuel.kurtz@chru-strasbourg.fr.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': 'Department of Medical Oncology, Centre Alexis Vautrin, Vandoeuvre les Nancy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Floquet', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Veillard', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kimmig', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dorum', 'Affiliation': 'Department of Gynecologic Oncology, The Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Elit', 'Affiliation': 'Department of Gynecologic Oncology, Juravinski Cancer Centre, Hamilton, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buck', 'Affiliation': 'Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Petru', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Beatson Oncology Centre, Gartnavel General Hospital, Glasgow, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Varsellona', 'Affiliation': 'Department of Gynecology and Obstetrics, AOR Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'University Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre site Hôtel-Dieu, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr001']
3379,21976386,Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial.,"BACKGROUND


To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial.
PATIENTS AND METHODS


CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤ 12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety.
RESULTS


A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm).
CONCLUSION


Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.",2012,"Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions.","['Patients with a treatment-free interval of >6 and ≤ 12 months', 'partially platinum-sensitive ovarian cancer patients', 'patients with partially platinum-sensitive recurrent ovarian cancer (ROC', 'CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy', '344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP']","['CP (carboplatin-paclitaxel', 'Carboplatin-PLD', 'Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel', 'CD or CP', 'CD [carboplatin-pegylated liposomal doxorubicin (PLD']","['Toxicities', 'grade 3/4 neutropenia', 'neuropathy and hypersensitivity reactions', 'Median PFS times', 'hazard ratio for PFS', 'progression-free survival (PFS', 'grade 2 alopecia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0962702', 'cui_str': 'calypso'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]",344.0,0.0802858,"Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gladieff', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, Toulouse, France. Electronic address: gladieff.laurence@claudiusregaud.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'Academic Division of Gynecologic Oncology, Mauriziano Hospital, Torino, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Rauglaudre', 'Affiliation': 'Department of clinical Oncology, Institut Sainte-Catherine, Avignon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vasey', 'Affiliation': 'University of Queensland, Brisbane, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Medical University of Vienna - General Hospital of Vienna, Vienna, Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Department of Medical Oncology, Medicale Hopital Hotel-Dieu and Universite Paris Descartes, Paris, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Reed', 'Affiliation': 'Gartnavel General Hospital, Beatson Oncology Centre, Glasgow, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Sacred Heart, Roma, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siena', 'Affiliation': ""Department of Oncology, Ospedale Niguarda Ca' Granda, Milano, Italy.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Helland', 'Affiliation': 'Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Elit', 'Affiliation': 'Department of Gynecologic Oncology, Juravinski Cancer Centre, Hamilton, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr441']
3380,21980193,Minimising critical organ irradiation in limited stage Hodgkin lymphoma: a dosimetric study of the benefit of involved node radiotherapy.,"BACKGROUND


Chemotherapy plus radiotherapy is the standard of care for patients with limited stage Hodgkin lymphoma (HL). Radiotherapy is evolving from involved field radiotherapy (IFRT) to involved node radiotherapy (INRT) to decrease radiotherapy-related morbidity. In the absence of long-term toxicity data, dose-volume metrics of organs at risk (OAR) provide a surrogate measure of toxicity risk.
PATIENTS AND METHODS


Ten female patients with stage I-IIA supradiaphragmatic HL were randomly selected. All patients had pre-chemotherapy computerised tomography (CT) and CT-positron emission tomography staging. Using CT planning, three radiotherapy plans were produced per patient: (i) IFRT, (ii) INRT using parallel-opposed beams and (iii) INRT using volumetric modulated arc therapy (VMAT). Radiotherapy dose was 30.6 Gy in 1.8 Gy fractions. OAR evaluated were lungs, breasts, thyroid, heart and coronary arteries.
RESULTS


Compared with IFRT, INRT significantly reduced mean doses to lungs (P < 0.01), breasts (P < 0.01), thyroid (P < 0.01) and heart (P < 0.01), on Wilcoxon testing. Compared with conventional INRT, VMAT improved dose conformality but increased low-dose radiation exposure to lungs and breasts. VMAT reduced the heart volume receiving 30 Gy (V30) by 85%.
CONCLUSIONS


Reduction from IFRT to INRT decreased the volumes of lungs, breasts and thyroid receiving high-dose radiation, suggesting the potential to reduce long-term second malignancy risks. VMAT may be useful for patients with pre-existing heart disease by minimising further cardiac toxicity risks.",2012,"Compared with IFRT, INRT significantly reduced mean doses to lungs (P < 0.01), breasts (P < 0.01), thyroid (P < 0.01) and heart (P < 0.01), on Wilcoxon testing.","['Ten female patients with stage', 'patients with limited stage Hodgkin lymphoma (HL', 'patients with pre-existing heart disease', 'limited stage Hodgkin lymphoma', 'I-IIA supradiaphragmatic HL', 'All patients had pre-chemotherapy computerised tomography (CT) and CT-positron emission tomography staging']","['Radiotherapy', 'IFRT, INRT', 'VMAT', 'INRT using volumetric modulated arc therapy (VMAT', 'IFRT, (ii) INRT using parallel-opposed beams and (iii', 'conventional INRT, VMAT', 'Chemotherapy plus radiotherapy', 'radiotherapy (IFRT) to involved node radiotherapy (INRT']","['OAR evaluated were lungs, breasts, thyroid, heart and coronary arteries']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]",10.0,0.0349671,"Compared with IFRT, INRT significantly reduced mean doses to lungs (P < 0.01), breasts (P < 0.01), thyroid (P < 0.01) and heart (P < 0.01), on Wilcoxon testing.","[{'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Campbell', 'Affiliation': 'Department of Radiation Oncology and Cancer Imaging. Electronic address: Belinda.Campbell@petermac.org.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hornby', 'Affiliation': 'Department of Radiotherapy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cunninghame', 'Affiliation': 'Department of Radiotherapy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Burns', 'Affiliation': 'Department of Radiotherapy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'MacManus', 'Affiliation': 'Department of Radiation Oncology and Cancer Imaging.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Radiation Oncology and Cancer Imaging.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lau', 'Affiliation': 'Centre for Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne; Department of Radiology, University of Melbourne, Parkville.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Department of Haematology, Peter MacCallum Cancer Centre, Melbourne; Department of Medicine, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wirth', 'Affiliation': 'Department of Radiation Oncology and Cancer Imaging.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr439']
3381,21986093,Prognostic and predictive role of ESR1 status for postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG 1-98 trial.,"BACKGROUND


Estrogen Receptor 1 (ESR1) aberrations may be associated with expression of estrogen receptor (ER) or progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2) or Ki-67 labeling index and prognosis.
PATIENTS AND METHODS


ESR1 was assessed in 1129 (81%) of 1396 postmenopausal Danish women with early breast cancer randomly assigned to receive 5 years of letrozole, tamoxifen or a sequence of these agents in the Breast International Group 1-98 trial and who had ER ≥ 1% after central review.
RESULTS


By FISH, 13.6% of patients had an ESR1-to-Centromere-6 (CEN-6) ratio ≥ 2 (amplified), and 4.2% had ESR1-to-CEN-6 ratio <0.8 (deleted). Deletion of ESR1 was associated with significantly lower levels of ER (P < 0.0001) and PgR (P = 0.02) and more frequent HER2 amplification. ESR1 deletion or amplification was associated with higher-Ki-67 than ESR1-normal tumors. Overall, there was no evidence of heterogeneity of disease-free survival (DFS) or in treatment effect according to ESR1 status. However, significant differences in DFS were observed for subsets based on a combination of ESR1 and HER2 status (P = 0.02).
CONCLUSIONS


ESR1 aberrations were associated with HER2 status, Ki-67 labeling index and ER and PgR levels. When combined with HER2, ESR1 may be prognostic but should not be used for endocrine treatment selection in postmenopausal women with endocrine-responsive early breast cancer.",2012,Deletion of ESR1 was associated with significantly lower levels of ER (P < 0.0001) and PgR (P = 0.02) and more frequent HER2 amplification.,"['postmenopausal women with endocrine-responsive early breast cancer', 'postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG 1-98 trial', 'or a sequence of these agents in the Breast International Group 1-98 trial and who had ER ≥ 1% after central review', 'ESR1 was assessed in 1129 (81%) of 1396 postmenopausal Danish women with early breast cancer randomly assigned to receive 5 years of']","['HER2, ESR1', 'letrozole, tamoxifen']","['heterogeneity of disease-free survival (DFS', 'ESR1 deletion or amplification', 'DFS', 'HER2 status, Ki-67 labeling index and ER and PgR levels', 'levels of ER']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1396.0,0.0599555,Deletion of ESR1 was associated with significantly lower levels of ER (P < 0.0001) and PgR (P = 0.02) and more frequent HER2 amplification.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ejlertsen', 'Affiliation': 'Danish Breast Cancer Cooperative Group Statistical Center; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: ejlertsen@rh.dk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Aldridge', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Nielsen', 'Affiliation': 'Dako A/S, Glostrup, Denmark.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA; Department of Biostatistics, Harvard School of Public Health; Department of Medicine, Harvard Medical School, Boston, USA.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Henriksen', 'Affiliation': 'Department of Breast Cancer Research, Institute of Cancer Biology, Danish Cancer Society, Copenhagen, Denmark.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Lykkesfeldt', 'Affiliation': 'Department of Breast Cancer Research, Institute of Cancer Biology, Danish Cancer Society, Copenhagen, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Dako A/S, Glostrup, Denmark.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA; Department of Biostatistics, Harvard School of Public Health; Department of Medicine, Harvard Medical School, Boston, USA; International Breast Cancer Study Group Statistical Center, Frontier Science and Technology Research Foundation, Boston, USA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA; International Breast Cancer Study Group Statistical Center, Frontier Science and Technology Research Foundation, Boston, USA.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Pathology, Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Division of Pathology and Laboratory Medicine, International Breast Cancer Study Group Pathology Review Office, European Institute of Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mouridsen', 'Affiliation': 'Danish Breast Cancer Cooperative Group Statistical Center; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr438']
3382,21986094,"Incidence, risk factors, and outcomes of osteonecrosis of the jaw: integrated analysis from three blinded active-controlled phase III trials in cancer patients with bone metastases.","BACKGROUND


Osteonecrosis of the jaw (ONJ) has been reported in patients receiving bisphosphonates for metastatic bone disease. ONJ incidence, risk factors, and outcomes were evaluated in a combined analysis of three phase III trials in patients with metastatic bone disease receiving antiresorptive therapies.
PATIENTS AND METHODS


Patients with bone metastases secondary to solid tumors or myeloma were randomly assigned to receive either s.c. denosumab (120 mg) or i.v. zoledronic acid (4 mg) every 4 weeks. On-study oral examinations were conducted by investigators at baseline and every 6 months. Oral adverse events were adjudicated by an independent blinded committee of dental experts.
RESULTS


Of 5723 patients enrolled, 89 (1.6%) patients were determined to have ONJ: 37 (1.3%) received zoledronic acid and 52 (1.8%) received denosumab (P = 0.13). Tooth extraction was reported for 61.8% of patients with ONJ. ONJ treatment was conservative in >95% of patients. As of October 2010, ONJ resolved in 36.0% of patients (29.7% for zoledronic acid and 40.4% for denosumab).
CONCLUSIONS


In this combined analysis of three prospective trials, ONJ was infrequent, management was mostly conservative, and healing occurred in over one-third of the patients. Educating physicians about oral health before and during bone-targeted therapy may help reduce ONJ incidence and improve outcomes.",2012,"As of October 2010, ONJ resolved in 36.0% of patients (29.7% for zoledronic acid and 40.4% for denosumab).
","['5723 patients enrolled, 89 (1.6%) patients were determined to have ONJ: 37 (1.3%) received', 'patients receiving bisphosphonates for metastatic bone disease', 'patients with metastatic bone disease receiving antiresorptive therapies', 'cancer patients with bone metastases', 'Patients with bone metastases secondary to solid tumors or myeloma']","['denosumab', 'zoledronic acid', 'ONJ']","['Tooth extraction', 'Incidence, risk factors, and outcomes of osteonecrosis of the jaw: integrated analysis', 'Oral adverse events', 'healing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",5723.0,0.124672,"As of October 2010, ONJ resolved in 36.0% of patients (29.7% for zoledronic acid and 40.4% for denosumab).
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Department of Urology, University of Montreal Montreal, Canada. Electronic address: fred.saad@umontreal.ca.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Brown', 'Affiliation': 'Cancer Research UK Clinical Centre, University of Leeds, Leeds, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Van Poznak', 'Affiliation': 'Department of Internal Medicine, University of Michigan Comprehensive Cancer Center, Ann Arbor, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Stemmer', 'Affiliation': 'Institute of Oncology, Davidoff Center, Rabin Medical Center, Beilinson Campus, Petah-Tiqva, Israel.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Stopeck', 'Affiliation': 'Department of Medicine, University of Arizona, Arizona Cancer Center, Tucson, USA.'}, {'ForeName': 'I J', 'Initials': 'IJ', 'LastName': 'Diel', 'Affiliation': 'Institute for Gynecologic Oncology, Center for Comprehensive Gynecology, Mannheim, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Henry', 'Affiliation': 'Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, USA.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Internal Medicine Department, Pontifícia Universidade Católica do Rio Grande do Sul School of Medicine, Rio Grande do Sul, Brazil.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'Department of Blood Diseases, Hôpital Claude Huriez, Lille, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Senecal', 'Affiliation': 'Northwest Medical Specialties Tacoma, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Medicine, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Global Biostatistical Sciences.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daniels', 'Affiliation': 'Global Safety.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Carrière', 'Affiliation': 'Global Safety.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dansey', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr435']
3383,23864097,Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer.,"BACKGROUND


There is an unmet need for predictive markers for the antiangiogenic agent bevacizumab in metastatic colorectal cancer (mCRC). We aimed to assess whether the location of the primary tumor is associated with bevacizumab effectiveness when combined with capecitabine and oxaliplatin (CAPEOX) in the first-line treatment of patients with mCRC.
PATIENTS AND METHODS


A cohort of 667 consecutive patients with mCRC from the general community treated from 2006 to 2011 with CAPEOX and bevacizumab as standard first-line therapy was compared with a cohort of 213 patients treated with CAPEOX from 2003 to 2006, before bevacizumab was approved. Main outcome measures were progression-free survival (PFS) and overall survival (OS). Differences in outcome were tested using Kaplan-Meier curves and log-rank tests, and multivariate analyses were carried out using Cox Proportional Hazards models.
RESULTS


Patients treated with CAPEOX and bevacizumab with primary tumors originating in the sigmoid colon and rectum had a significantly better outcome than patients with primary tumors originating from the cecum to the descending colon, both for PFS (median PFS 9.3 versus 7.2 months; hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.56-0.82) and for OS (median OS 23.5 versus 13.0 months; HR 0.47, 95% CI 0.38-0.57). This difference was confirmed in multivariate analyses after adjustment for other potentially prognostic factors. For patients treated with CAPEOX, there was no association between primary tumor location and outcome, neither in unadjusted nor adjusted analyses.
CONCLUSIONS


The addition of bevacizumab to CAPEOX in first-line treatment of patients with mCRC may primarily benefit patients with primary tumors originating in the rectum and sigmoid colon. This hypothesis needs to be validated in data from completed randomized trials.
CLINICALTRIALSGOV IDENTIFICATION NUMBER


NCT00212615.",2013,"RESULTS


Patients treated with CAPEOX and bevacizumab with primary tumors originating in the sigmoid colon and rectum had a significantly better outcome than patients with primary tumors originating from the cecum to the descending colon, both for PFS (median PFS 9.3 versus 7.2 months; hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.56-0.82) and for OS (median OS 23.5 versus 13.0 months; HR 0.47, 95% CI 0.38-0.57).","['patients with mCRC may primarily benefit patients with primary tumors originating in the rectum and sigmoid colon', 'patients with metastatic colorectal cancer', 'metastatic colorectal cancer (mCRC', 'patients with mCRC', 'A cohort of 667 consecutive patients with mCRC from the general community treated from 2006 to 2011 with', 'as standard first-line therapy was compared with a cohort of 213 patients treated with CAPEOX from 2003 to 2006, before']","['bevacizumab', 'antiangiogenic agent bevacizumab', 'capecitabine and oxaliplatin (CAPEOX', 'bevacizumab to CAPEOX', 'CAPEOX and bevacizumab']","['progression-free survival (PFS) and overall survival (OS', 'sigmoid colon and rectum']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0521377', 'cui_str': 'Rectum and sigmoid colon, CS'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0596087', 'cui_str': 'Inhibitors, Angiogenetic'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}]",667.0,0.154344,"RESULTS


Patients treated with CAPEOX and bevacizumab with primary tumors originating in the sigmoid colon and rectum had a significantly better outcome than patients with primary tumors originating from the cecum to the descending colon, both for PFS (median PFS 9.3 versus 7.2 months; hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.56-0.82) and for OS (median OS 23.5 versus 13.0 months; HR 0.47, 95% CI 0.38-0.57).","[{'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Boisen', 'Affiliation': 'Department of Oncology;. Electronic address: mogens.karsboel.boisen@regionh.dk.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Johansen', 'Affiliation': 'Department of Oncology;; Department of Medicine, Herlev Hospital, Copenhagen University Hospital, Herlev.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dehlendorff', 'Affiliation': 'Department of Statistics, Bioinformatics and Registry, Danish Cancer Society, Copenhagen.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Larsen', 'Affiliation': 'Department of Oncology, Roskilde Sygehus, Roskilde.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Østerlind', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Department of Oncology, Västerås County Hospital, Västerås, Sweden;; Department of Oncology, Aalborg Sygehus, Aalborg.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Nielsen', 'Affiliation': 'Department of Oncology and Palliation, Hillerød Hospital, Hillerød.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Tarpgaard', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense.'}, {'ForeName': 'N H', 'Initials': 'NH', 'LastName': 'Holländer', 'Affiliation': 'Department of Oncology and Hematology, Næstved Sygehus, Næstved.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Keldsen', 'Affiliation': 'Department of Oncology, Herning Hospital, Herning.'}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Hansen', 'Affiliation': 'Department of Oncology, Vejle Sygehus, Vejle.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, Sydvestjysk Sygehus, Esbjerg, Denmark.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt253']
3384,21212157,A phase II double-blind study to investigate efficacy and safety of two doses of the triple angiokinase inhibitor BIBF 1120 in patients with relapsed advanced non-small-cell lung cancer.,"BACKGROUND


To assess the efficacy, safety, tolerability and pharmacokinetics of BIBF 1120 in patients with stage IIIB/IV non-small-cell lung cancer (NSCLC).
METHODS


Patients with locally advanced or metastatic relapsed NSCLC in whom first- or second-line platinum-based chemotherapy failed were randomly allocated to daily 250 mg BIBF 1120 b.i.d. or 150 mg BIBF 1120 b.i.d. Primary end points were progression-free survival (PFS) and objective tumour response (RECIST). Incidence and severity of adverse events (AEs) were reported.
RESULTS


Seventy-three patients received BIBF 1120. Median PFS was 6.9 weeks, with no significant difference between treatment arms. Median overall survival (OS) was 21.9 weeks. Eastern Cooperative Oncology Group (ECOG) 0-1 patients (n = 56) had a median PFS of 11.6 weeks and a median OS of 37.7 weeks. Tumour stabilisation was achieved in 46% of patients (ECOG 0-1 patients: 59%), with one confirmed partial response (250 mg b.i.d.). Most commonly reported drug-related AEs were nausea (57.5%), diarrhoea (47.9%), vomiting (42.5%), anorexia (28.8%), abdominal pain (13.7%) and reversible alanine transaminase (13.7%) and aspartate aminotransferase elevations (9.6%). BIBF 1120 displayed dose-linear pharmacokinetic characteristics.
CONCLUSION


Continuous treatment with BIBF 1120 was well tolerated, with no difference in efficacy between treatment arms. PFS and objective response with single-agent treatment in advanced disease warrants further exploration.",2011,"Most commonly reported drug-related AEs were nausea (57.5%), diarrhoea (47.9%), vomiting (42.5%), anorexia (28.8%), abdominal pain (13.7%) and reversible alanine transaminase (13.7%) and aspartate aminotransferase elevations (9.6%).","['Patients with locally advanced or metastatic relapsed NSCLC in whom first- or second-line platinum-based chemotherapy failed', 'patients with stage IIIB/IV non-small-cell lung cancer (NSCLC', 'patients with relapsed advanced non-small-cell lung cancer']",['triple angiokinase inhibitor BIBF'],"['Incidence and severity of adverse events (AEs', 'diarrhoea', 'progression-free survival (PFS) and objective tumour response (RECIST', 'vomiting', 'Tumour stabilisation', 'efficacy and safety', 'efficacy, safety, tolerability and pharmacokinetics', 'anorexia', 'nausea', 'reversible alanine transaminase', 'Median PFS', 'abdominal pain', 'PFS and objective response', 'Median overall survival (OS', 'aspartate aminotransferase elevations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",1120.0,0.296289,"Most commonly reported drug-related AEs were nausea (57.5%), diarrhoea (47.9%), vomiting (42.5%), anorexia (28.8%), abdominal pain (13.7%) and reversible alanine transaminase (13.7%) and aspartate aminotransferase elevations (9.6%).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Hamburg. Electronic address: dr.martin.reck@web.de.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kaiser', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Eschbach', 'Affiliation': 'Department of Pneumology, Asklepios Hospitals Harburg, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stefanic', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Love', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Gatzemeier', 'Affiliation': 'Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Hamburg.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stopfer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'von Pawel', 'Affiliation': 'Department of Pneumology, Asklepios Hospitals Harburg, Hamburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq618']
3385,25070546,"A randomised, placebo-controlled trial of weekly paclitaxel and saracatinib (AZD0530) in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer†.","BACKGROUND


We investigated whether the Src inhibitor saracatinib (AZD0530) improved efficacy of weekly paclitaxel in platinum-resistant ovarian cancer.
PATIENTS AND METHODS


Patients with platinum-resistant ovarian, fallopian tube or primary peritoneal cancer were randomised 2 : 1 to receive 8-week cycles of weekly paclitaxel (wPxl; 80 mg/m(2)/week ×6 with 2-week break) plus saracatinib (S; 175 mg o.d.) or placebo (P) continuously, starting 1 week before wPxl, until disease progression. Patients were stratified by taxane-free interval (<6 versus ≥6 months/no prior taxane). The primary end point was progression-free survival (PFS) rate at 6 months. Secondary end points included overall survival (OS) and response rate (RR).
RESULTS


A total of 107 patients, median age 63 years, were randomised. Forty-three (40%) had received >2 lines of prior chemotherapy. The 6-month PFS rate was 29% (wPxl + S) versus 34% (wPxl + P) (P = 0.582). Median PFS was 4.7 versus 5.3 months (hazard ratio 1.00, 95% confidence interval 0.65-1.54; P = 0.99). RR (complete + partial) was 29% (wPxl + S) versus 43% (wPxl + P), P value = 0.158. Grade 3/4 adverse events were 36% versus 31% (P = 0.624); the most frequent G3/4 toxicities were vomiting (5.8% saracatinib versus 8.6% placebo), abdominal pain (5.8% versus 0%) and diarrhoea (4.3% versus 5.7%). Febrile neutropenia was more common in the saracatinib arm (4.3%) than placebo (0%). Response, PFS and OS were all significantly (P < 0.05) better in patients with taxane interval ≥6 months/no prior taxane (n = 85) than those <6 months (n = 22), regardless of randomisation.
CONCLUSIONS


Saracatinib does not improve activity of weekly paclitaxel in platinum-resistant ovarian cancer. Taxane-free interval of ≥6 months/no prior taxane was associated with better outcome in both groups.
TRIALS REGISTRATION


Clinicaltrials.gov NCT01196741; ISRCTN 32163062.",2014,Febrile neutropenia was more common in the saracatinib arm (4.3%) than placebo (0%).,"['platinum-resistant ovarian, fallopian tube or primary peritoneal cancer†', 'Patients with platinum-resistant ovarian, fallopian tube or primary peritoneal cancer', 'platinum-resistant ovarian cancer', '107 patients, median age 63 years']","['Taxane', 'Src inhibitor saracatinib (AZD0530', 'paclitaxel', 'placebo', 'taxane', 'paclitaxel (wPxl; 80 mg/m(2)/week ×6 with 2-week break) plus saracatinib (S; 175 mg o.d.) or placebo', 'paclitaxel and saracatinib (AZD0530']","['Grade 3/4 adverse events', 'vomiting', 'diarrhoea', 'Median PFS', 'abdominal pain', 'progression-free survival (PFS) rate', 'Febrile neutropenia', 'overall survival (OS) and response rate (RR', 'Response, PFS and OS', '6-month PFS rate']","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2828242', 'cui_str': 'saracatinib'}, {'cui': 'C1706679', 'cui_str': 'AZD0530'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",107.0,0.429117,Febrile neutropenia was more common in the saracatinib arm (4.3%) than placebo (0%).,"[{'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'McNeish', 'Affiliation': ""Institute of Cancer Sciences, University of Glasgow, Glasgow; Department of Medical Oncology, St Bartholomew's Hospital, London. Electronic address: iain.mcneish@glasgow.ac.uk.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'CR UK and UCL Cancer Trials Centre, University College London, London.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'CR UK and UCL Cancer Trials Centre, University College London, London.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'James', 'Affiliation': 'CR UK and UCL Cancer Trials Centre, University College London, London.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Department of Medical Oncology, Royal Marsden Hospital, Sutton.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Division of Cancer Services, Mount Vernon Hospital, Northwood.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hall', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie Hospital, Manchester.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Earl', 'Affiliation': ""Department of Oncology, Addenbrooke's Hospital, Cambridge.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Medical Oncology, Royal Marsden Hospital, Sutton.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'Department of Medical Oncology, University College Hospital, London.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raja', 'Affiliation': 'CR UK and UCL Cancer Trials Centre, University College London, London.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feeney', 'Affiliation': 'CR UK and UCL Cancer Trials Centre, University College London, London.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': ""Department of Medical Oncology, St Bartholomew's Hospital, London.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dawson-Athey', 'Affiliation': ""Department of Medical Oncology, St Bartholomew's Hospital, London.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Persic', 'Affiliation': ""Department of Oncology, Queen's Hospital, Burton upon Trent, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'CR UK and UCL Cancer Trials Centre, University College London, London.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu363']
3386,23788750,Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer.,"BACKGROUND


The progesterone-receptor (PR) antagonists onapristone (type I) and mifepristone (type II) showed modest activity in hormone-receptor-positive breast cancer; however, onapristone in particular was associated with hepatotoxicity. Lonaprisan is a novel, type III PR antagonist that was well tolerated in phase I studies.
PATIENTS AND METHODS


This randomized, open-label, phase II study evaluated the efficacy and tolerability of lonaprisan as second-line endocrine therapy in postmenopausal women with stage IV, PR-positive, HER2-negative, metastatic breast cancer.
RESULTS


Patients received once-daily lonaprisan 25 mg (n = 34) or 100 mg (n = 34). The primary objective was not met (≥ 35% clinical benefit rate: complete/partial responses at any time until month 6 or stable disease [SD] for ≥ 6 months from start of treatment). There were no complete/partial responses. In the 25 mg and 100 mg groups, 6 of 29 patients (21%) and 2 of 29 patients (7%), respectively, had SD ≥ 6 months. Overall, 61 of 68 patients (90%) had ≥ 1 adverse event (AE), the most frequent (≥ 10% overall) being fatigue, hot flush, dyspnoea, nausea, asthenia, headache, constipation, vomiting, and decreased appetite; 33 patients had serious AEs.
CONCLUSION


Lonaprisan showed limited efficacy as second-line endocrine therapy in postmenopausal women with PR-positive metastatic breast cancer.",2013,There were no complete/partial responses.,"['postmenopausal women with PR-positive metastatic breast cancer', 'postmenopausal women with stage IV, PR-positive, HER2-negative, metastatic breast cancer', 'progesterone receptor-positive breast cancer']","['lonaprisan as second-line endocrine therapy', 'lonaprisan as second-line therapy', 'second-line endocrine therapy', 'progesterone-receptor (PR) antagonists onapristone (type I) and mifepristone']","['efficacy and tolerability', 'fatigue, hot flush, dyspnoea, nausea, asthenia, headache, constipation, vomiting, and decreased appetite; 33 patients had serious AEs', 'clinical benefit rate: complete/partial responses at any time until month 6 or stable disease [SD']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C2347691', 'cui_str': 'lonaprisan'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4707942', 'cui_str': 'Progesterone receptor antagonist'}, {'cui': 'C0069492', 'cui_str': 'onapristone'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0231003,There were no complete/partial responses.,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jonat', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany. Electronic address: walter.jonat@uksh.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Department of Medical Oncology and Lyon Cancer Research Centre, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Breast Centre St. Gallen, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kuss', 'Affiliation': 'Bayer Pharma AG, Berlin, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Reimann', 'Affiliation': 'Bayer Pharma AG, Berlin, Germany.'}, {'ForeName': 'J F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'Academic Division of Breast Surgery, University of Nottingham, Royal Derby Hospital, Derby, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt216']
3387,25057173,EGFR biomarkers predict benefit from vandetanib in combination with docetaxel in a randomized phase III study of second-line treatment of patients with advanced non-small cell lung cancer.,"BACKGROUND


ZODIAC was a randomized phase III study of second-line treatment in patients with advanced non-small cell lung cancer (NSCLC) that evaluated the addition of vandetanib to docetaxel. The study showed a statistically significant improvement in progression-free survival and objective response rate, but not in overall survival for unselected patients. This study evaluated epidermal growth factor receptor (EGFR) gene mutation, copy number gain, and protein expression, and KRAS gene mutation, in pretreatment tumor samples as potential biomarkers predicting benefit from vandetanib as second-line treatment of NSCLC.
PATIENTS AND METHODS


After progression following first-line chemotherapy, 1391 patients with locally advanced or metastatic (stage IIIB/IV) NSCLC were randomized 1 : 1 to receive vandetanib (100 mg/day) plus docetaxel (75 mg/m(2) every 21 days) or placebo plus docetaxel in the ZODIAC study. Archival tumor samples (n = 570) were collected from consenting patients (n = 958) for predefined, prospective biomarker analyses.
RESULTS


Of evaluable samples, 14% were EGFR mutation positive, 35% were EGFR FISH positive, 88% were EGFR protein expression positive, and 13% were KRAS mutation positive. Compared with the overall study population, in which progression-free survival (PFS) [hazard ratio (HR) = 0.79] but not OS (HR = 0.91) were significantly improved with vandetanib, there was greater relative clinical benefit for patients with EGFR mutation-positive tumors [PFS HR 0.51, confidence interval (CI) 0.25-1.06 and OS HR 0.46, CI 0.14-1.57] and EGFR FISH-positive tumors (PFS HR 0.61, CI 0.39-0.94 and OS HR 0.48, CI 0.28-0.84). Similarly, patients with EGFR mutation or FISH-positive tumor samples who received vandetanib had an increased chance of objective tumor response (odds ratios 3.34, CI 0.8-13.89, and 3.90, CI 1.02-14.82, respectively). There did not appear to be benefit for vandetanib in patients with KRAS mutation-positive tumors.
CONCLUSIONS


High EGFR gene copy number or activating EGFR mutations may identify patient subgroups who receive increased clinical benefit from vandetanib in combination with docetaxel in second-line NSCLC.
CLINICALTRIALSGOV


NCT00312377.",2014,"The study showed a statistically significant improvement in progression-free survival and objective response rate, but not in overall survival for unselected patients.","['patients with KRAS mutation-positive tumors', 'patients with advanced non-small cell lung cancer', 'patients with advanced non-small cell lung cancer (NSCLC', 'Archival tumor samples (n = 570) were collected from consenting patients (n = 958) for predefined, prospective biomarker analyses', '1391 patients with locally advanced or metastatic (stage IIIB/IV']","['placebo plus docetaxel', 'docetaxel', 'vandetanib']","['epidermal growth factor receptor (EGFR) gene mutation, copy number gain, and protein expression, and KRAS gene mutation', 'overall survival', 'EGFR protein expression positive', 'chance of objective tumor response', 'progression-free survival and objective response rate', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1121849', 'cui_str': 'Vandetanib'}]","[{'cui': 'C3266992', 'cui_str': 'Epidermal growth factor receptor gene mutation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0596611'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1391.0,0.212152,"The study showed a statistically significant improvement in progression-free survival and objective response rate, but not in overall survival for unselected patients.","[{'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Division of Cancer Medicine, Department of Thoracic/Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Lockwood', 'Affiliation': 'Oncology iMED, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Section of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital, Yale, New Haven.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Johnson', 'Affiliation': ""Department of Medical Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, USA; Department of Medicine, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, USA.""}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK. Electronic address: anderson.ryan@oncology.ox.ac.uk.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu269']
3388,25070545,"Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study.","BACKGROUND


Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (s.c.) trastuzumab, delivered via single-use injection device (SID), over the intravenous (i.v.) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here, we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where s.c. trastuzumab was delivered via hand-held syringe.
PATIENTS AND METHODS


Patients were randomized to receive four adjuvant cycles of 600 mg fixed-dose s.c. trastuzumab followed by four cycles of standard i.v. trastuzumab, or vice versa. The primary endpoint was overall preference proportions for s.c. or i.v., assessed by patient interviews in the evaluable ITT population.
RESULTS


A total of 245 patients were randomized to receive s.c. followed by i.v. and 243 received i.v. followed by s.c. (evaluable ITT populations: 235 and 232 patients, respectively). s.c. was preferred by 415/467 [88.9%; 95% confidence interval (CI) 85.7-91.6; P < 0.0001; two-sided test against null hypothesis of 65% s.c. preference]; 45/467 preferred i.v. (9.6%; 95% CI 7-13); 7/467 indicated no preference (1.5%; 95% CI 1-3). Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled s.c. and i.v. periods, respectively (P < 0.05; 2 × 2 χ(2)); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5.
CONCLUSIONS


PrefHer revealed compelling and consistent patient preferences for s.c. over i.v. trastuzumab, regardless of SID or hand-held syringe delivery. s.c. was well tolerated and safety was consistent with previous reports, including the HannaH study (NCT00950300). No new safety signals were identified compared with the known i.v. profile in EBC. PrefHer and HannaH confirm that s.c. trastuzumab is a validated and preferred option over i.v. for improving patients' care in HER2-positive breast cancer.
CLINICALTRIALSGOV REGISTRATION NUMBER


NCT01401166.",2014,Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled s.c. and i.v.,"['A total of 245 patients', 'Patients', 'HER2-positive early breast cancer', 'Patients with HER2-positive early breast cancer (EBC', '488 patients in the international, randomized, two-cohort PrefHer study']","['trastuzumab', 'subcutaneous trastuzumab', 'trastuzumab, or vice versa']","['overall preference proportions', 'adverse events', 'tolerated and safety']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",245.0,0.186255,Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled s.c. and i.v.,"[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Department of Medical Oncology, University Hospital Jean Minjoz, Besançon. Electronic address: xavier.pivot@univ-fcomte.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gligorov', 'Affiliation': 'Medical Oncology Department, APHP Hôpital Tenon, Paris; UPMC, Institut Universitaire de Cancérologie, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'Early Drug Development for Innovative Therapies Division, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Knoop', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Division of Medical Oncology, Sunnybrook Odette Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jenkins', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Scotto', 'Affiliation': 'Global Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Osborne', 'Affiliation': 'Global Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu364']
3389,24928832,"A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck.","BACKGROUND


Afatinib is an oral, irreversible ErbB family blocker that has shown activity in epidermal growth factor receptor (EGFR)-mutated lung cancer. We hypothesized that the agent would have greater antitumor activity compared with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients, whose disease has progressed after platinum-containing therapy.
PATIENTS AND METHODS


An open-label, randomized, phase II trial was conducted in 43 centers; 124 patients were randomized (1 : 1) to either afatinib (50 mg/day) or cetuximab (250 mg/m(2)/week) until disease progression or intolerable adverse events (AEs) (stage I), with optional crossover (stage II). The primary end point was tumor shrinkage before crossover assessed by investigator (IR) and independent central review (ICR).
RESULTS


A total of 121 patients were treated (61 afatinib, 60 cetuximab) and 68 crossed over to stage II (32 and 36 respectively). In stage I, mean tumor shrinkage by IR/ICR was 10.4%/16.6% with afatinib and 5.4%/10.1% with cetuximab (P = 0.46/0.30). Objective response rate was 16.1%/8.1% with afatinib and 6.5%/9.7% with cetuximab (IR/ICR). Comparable disease control rates were observed with afatinib (50%) and cetuximab (56.5%) by IR; similar results were seen by ICR. Most common grade ≥3 drug-related AEs (DRAEs) were rash/acne (18% versus 8.3%), diarrhea (14.8% versus 0%), and stomatitis/mucositis (11.5% versus 0%) with afatinib and cetuximab, respectively. Patients with DRAEs leading to treatment discontinuation were 23% with afatinib and 5% with cetuximab. In stage II, disease control rate (IR/ICR) was 38.9%/33.3% with afatinib and 18.8%/18.8% with cetuximab.
CONCLUSION


Afatinib showed antitumor activity comparable to cetuximab in R/M HNSCC in this exploratory phase II trial, although more patients on afatinib discontinued treatment due to AEs. Sequential EGFR/ErbB treatment with afatinib and cetuximab provided sustained clinical benefit in patients after crossover, suggesting a lack of cross-resistance.",2014,"In stage II, disease control rate (IR/ICR) was 38.9%/33.3% with afatinib and 18.8%/18.8% with cetuximab.
","['recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients, whose disease has progressed after platinum-containing therapy', '43 centers; 124 patients', '121 patients were treated (61 afatinib, 60 cetuximab) and 68 crossed over to stage II (32 and 36 respectively', 'metastatic or recurrent squamous cell carcinoma of the head and neck']","['afatinib and cetuximab', 'cetuximab', 'afatinib versus cetuximab', 'cetuximab (250 mg/m(2)/week) until disease progression or intolerable adverse events (AEs', 'afatinib']","['disease control rate (IR/ICR', 'tumor shrinkage before crossover assessed by investigator (IR) and independent central review (ICR', 'disease control rates', 'Objective response rate', 'antitumor activity', 'rash/acne', 'stomatitis/mucositis', 'diarrhea', 'mean tumor shrinkage by IR/ICR']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C4304995', 'cui_str': 'Recurrent squamous cell carcinoma'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage (finding)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",121.0,0.0136199,"In stage II, disease control rate (IR/ICR) was 38.9%/33.3% with afatinib and 18.8%/18.8% with cetuximab.
","[{'ForeName': 'T Y', 'Initials': 'TY', 'LastName': 'Seiwert', 'Affiliation': 'Department of Medicine, University of Chicago Medical Centre, Chicago, USA. Electronic address: tseiwert@medicine.bsd.uchicago.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Department of Medicine, Université de Lyon, Lyon.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': ""Institut du Cancer de Montpellier Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Department of Medical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Division of Oncology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hitt', 'Affiliation': 'Centro Integral Oncológico Clara Campal (CIOCC), Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Degardin', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd, Shanghai, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blackman', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ehrnrooth', 'Affiliation': 'Boehringer Ingelheim Danmark A/S, Copenhagen, Denmark.'}, {'ForeName': 'E E W', 'Initials': 'EEW', 'LastName': 'Cohen', 'Affiliation': 'Department of Medicine, University of California San Diego Moores Cancer Center, La Jolla, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu216']
3390,24942277,S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial).,"BACKGROUND


S-1 is an oral fluoropyrimidine whose antitumor effects have been demonstrated in treating various gastrointestinal cancers, including metastatic colon cancer, when administered as monotherapy or in combination chemotherapy. We conducted a randomized phase III study investigating the efficacy of S-1 as adjuvant chemotherapy for colon cancer by evaluating its noninferiority to tegafur-uracil plus leucovorin (UFT/LV).
PATIENTS AND METHODS


Patients aged 20-80 years with curatively resected stage III colon cancer were randomly assigned to receive S-1 (80-120 mg/day on days 1-28 every 42 days; four courses) or UFT/LV (UFT: 300-600 mg/day and LV: 75 mg/day on days 1-28 every 35 days; five courses). The primary end point was disease-free survival (DFS) at 3 years.
RESULTS


A total of 1518 patients (758 and 760 in the S-1 and UFT/LV group, respectively) were included in the full analysis set. The 3-year DFS rate was 75.5% and 72.5% in the S-1 and UFT/LV group, respectively. The stratified hazard ratio for DFS in the S-1 group compared with the UFT/LV group was 0.85 (95% confidence interval: 0.70-1.03), demonstrating the noninferiority of S-1 (noninferiority stratified log-rank test, P < 0.001). In the subgroup analysis, no significant interactions were identified between the major baseline characteristics and the treatment groups.
CONCLUSION


Adjuvant chemotherapy using S-1 for stage III colon cancer was confirmed to be noninferior in DFS compared with UFT/LV. S-1 could be a new treatment option as adjuvant chemotherapy for colon cancer.
CLINICALTRIALSGOV


NCT00660894.",2014,"The 3-year DFS rate was 75.5% and 72.5% in the S-1 and UFT/LV group, respectively.","['1518 patients (758 and 760 in the S-1 and UFT/LV group, respectively) were included in the full analysis set', 'stage III colon cancer', 'Patients aged 20-80 years with curatively resected stage III colon cancer']","['Adjuvant chemotherapy', 'S-1', 'UFT/LV', 'S-1 as adjuvant chemotherapy', 'tegafur-uracil plus leucovorin (UFT/LV', 'fluoropyrimidine', 'UFT/LV (UFT: 300-600 mg/day and LV']","['3-year DFS rate', 'stratified hazard ratio for DFS', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0041917', 'cui_str': 'Uracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",1518.0,0.478047,"The 3-year DFS rate was 75.5% and 72.5% in the S-1 and UFT/LV group, respectively.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Osaka.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ishiguro', 'Affiliation': 'Department of Translational Oncology, Tokyo Medical and Dental University, Graduate School, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ikejiri', 'Affiliation': 'Department of Surgery, Center of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, Iwate.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Nakamoto', 'Affiliation': 'Department of Surgery, Kobe City Medical Center West Hospital, Hyogo.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kinugasa', 'Affiliation': 'Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Takagane', 'Affiliation': 'Department of Surgery, Hakodate Goryoukaku Hospital, Hokkaido.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Department of Colorectal Surgery, Japanese Red Cross Medical Center, Tokyo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Surgery, Saiseikai Utsunomiya Hospital, Tochigi.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Takii', 'Affiliation': 'Department of Surgery, Niigata Cancer Center Hospital, Niigata.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Surgery, National Defense Medical College, Saitama.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kotake', 'Affiliation': 'Department of Surgery, Tochigi Cancer Center, Tochigi.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kameoka', 'Affiliation': ""Department of Surgery II, Tokyo Women's Medical University, Tokyo.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Surgical Oncology and Vascular Surgery, The University of Tokyo, Graduate School of Medicine, Tokyo.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Kanagawa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Clinical Oncology, St Marianna University, Kanagawa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Department of Surgery, Hyogo College of Medicine, Hyogo.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nakatani', 'Affiliation': 'Department of Statistical Analysis, Translational Research Informatics Center, Hyogo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Department of Surgical Oncology, Tokyo Medical and Dental University, Graduate School, Tokyo, Japan. Electronic address: k-sugi.srg2@tmd.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu232']
3391,25028705,Letter to the editor on 'Phase III trial of concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy for limited-disease small cell lung cancer'.,,2014,,['limited-disease small cell lung cancer'],['concurrent thoracic radiotherapy with either first- or third-cycle chemotherapy'],[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.0165011,,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Sun', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Electronic address: tntntn3@gmail.com.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu244']
3392,23884439,Impact of excision repair cross-complementing gene 1 (ERCC1) on the outcomes of patients with advanced gastric cancer: correlative study in Japan Clinical Oncology Group Trial JCOG9912.,"BACKGROUND


Since the best chemotherapy regimen for each patient with advanced gastric cancer is uncertain, we aimed to identify molecular prognostic or predictive biomarkers from biopsy specimens in JCOG9912, a randomized phase III trial for advanced gastric cancer.
PATIENTS AND METHODS


Endoscopic biopsy specimens from primary lesions were collected in 445 of 704 randomized patients in JCOG9912. We measured the mRNA expression of excision repair cross-complementing group 1 (ERCC1), thymidylate synthase, dihydropyrimidine dehydrogenase, and five other genes, then, categorized them into low and high groups relative to the median, and examined whether gene expression was associated with efficacy end point.
RESULTS


Multivariate analyses showed that high ERCC1 expression [HR 1.37; 95% confidence interval (CI) 1.08-1.75; P = 0.010], performance status ≥ 1 (HR 1.45; 95% CI 1.13-1.86; P = 0.004), and number of metastatic sites ≥ 2 (HR 1.66; 95% CI 1.28-1.86; P < 0.001) were associated with a poor prognosis, and recurrent disease (versus unresectable; HR 0.75; 95% CI 0.56-1.00; P = 0.049) was associated with a favorable prognosis. None of these molecular factors were a predictive marker for choosing irinotecan plus cisplatin or 5-fluorouracil rather than S-1.
CONCLUSION


These correlative analyses suggest that ERCC1 is an independent prognostic factor for overall survival in the first-line treatment of gastric cancer.
CLINICAL TRIAL NUMBER


C000000062, www.umin.ac.jp.",2013,"We measured the mRNA expression of excision repair cross-complementing group 1 (ERCC1), thymidylate synthase, dihydropyrimidine dehydrogenase, and five other genes, then, categorized them into low and high groups relative to the median, and examined whether gene expression was associated with efficacy end point.
","['patients with advanced gastric cancer', 'patient with advanced gastric cancer', 'Endoscopic biopsy specimens from primary lesions were collected in 445 of 704 randomized patients in']","['JCOG9912', 'ERCC1', 'excision repair cross-complementing gene 1 (ERCC1', 'irinotecan plus cisplatin or 5-fluorouracil']","['recurrent disease', 'high ERCC1 expression', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0184980', 'cui_str': 'Endoscopic biopsy (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0015249', 'cui_str': 'Excision Repair'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0009498', 'cui_str': 'Complement System Proteins'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",704.0,0.136208,"We measured the mRNA expression of excision repair cross-complementing group 1 (ERCC1), thymidylate synthase, dihydropyrimidine dehydrogenase, and five other genes, then, categorized them into low and high groups relative to the median, and examined whether gene expression was associated with efficacy end point.
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo. Electronic address: yayamada@ncc.go.jp.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, Shikoku Cancer Center, Matsuyama.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Kita-adachi.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Department of Gastroenterology, Chiba Cancer Center, Chiba.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kobe City Medical Center General Hospital, Kobe.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Gastroenterology, Keio University, School of Medicine, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Konishi', 'Affiliation': 'Department of Gastroenterology, Showa University, School of Medicine, Tokyo.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Tonan Hospital, Sapporo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Amagai', 'Affiliation': 'Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ohkawa', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': ""Department of Gastroenterology, Yokohama Municipal Citizen's Hospital, Yokohama.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nishisaki', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kawai', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Takashima', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center, Tokyo.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center, Tokyo.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'National Cancer Center, Exploratory Oncology Research and Clinical Trial Center, Kashiwa, Japan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt238']
3393,23942774,Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20).,"BACKGROUND


In a phase III trial (ClinicalTrials.gov registration ID: NCT00094653), ipilimumab significantly improved survival versus a vaccine control in pretreated patients with metastatic melanoma. Here, we characterize outcomes of those patients who survived ≥ 2 years.
METHODS


Patients were randomized (3 : 1 : 1) to receive ipilimumab 3 mg/kg + gp100 vaccine, ipilimumab 3 mg/kg + placebo, or gp100 vaccine alone. Baseline demographic data, duration of survival, responses, and safety among patients with ≥ 2 years' survival were analyzed.
RESULTS


Among 676 randomized patients, 474 and 259 patients had at least 2 or 3 years of potential follow-up, respectively, and were eligible for analysis. Among these, 94 (20%) and 42 (16%) survived ≥ 2 and ≥ 3 years, respectively. Survival rates at 2 and 3 years were 25% (24 of 95) and 25% (13 of 53) with ipilimumab alone and 19% (54 of 284) and 15% (24 of 156) with ipilimumab plus gp100. Safety among patients with ≥ 2 years' survival was comparable with the overall study population, with the onset of new ipilimumab-related toxic effect (all grades) reported in 6 of 78 (8%) patients.
CONCLUSIONS


Ipilimumab results in survival of ≥ 2 years in one-fifth of pretreated patients with 2 years potential follow-up in a phase III trial. New onset, low-grade events starting after administration of the last dose were infrequent.
TRIAL REGISTRATION ID


NCT00094653.",2013,Survival rates at 2 and 3 years were 25% (24 of 95) and 25% (13 of 53) with ipilimumab alone and 19% (54 of 284) and 15% (24 of 156) with ipilimumab plus gp100.,"['Patients', 'pretreated patients with metastatic melanoma', 'patients who survived ≥ 2 years', 'metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20', '676 randomized patients, 474 and 259 patients had at least 2 or 3 years of potential follow-up, respectively, and were eligible for analysis', 'patients with ≥ 2 years']","['Ipilimumab', 'ipilimumab', 'ipilimumab 3 mg/kg + gp100 vaccine, ipilimumab 3 mg/kg + placebo, or gp100 vaccine alone']","['Efficacy and safety', 'survival', 'Survival rates', ""Baseline demographic data, duration of survival, responses, and safety among patients with ≥ 2 years' survival""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1692339', 'cui_str': 'MDX010'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",676.0,0.405787,Survival rates at 2 and 3 years were 25% (24 of 95) and 25% (13 of 53) with ipilimumab alone and 19% (54 of 284) and 15% (24 of 156) with ipilimumab plus gp100.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'McDermott', 'Affiliation': 'Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, USA. Electronic address: dmcdermo@bidmc.harvard.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': 'Department of Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'T-T', 'Initials': 'TT', 'LastName': 'Chen', 'Affiliation': 'Oncology Biostatistics, Bristol-Myers Squibb, Wallingford, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Day"", 'Affiliation': 'Department of Medical Oncology, Los Angeles Skin Cancer Institute, The Beverly Hills Cancer Center, Beverly Hills, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt291']
3394,23946328,Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma.,"BACKGROUND


Pixantrone is an aza-anthracenedione with enhanced, preclinical antitumor activity and reduced cardiotoxicity compared with doxorubicin.
PATIENTS AND METHODS


We compared the efficacy and toxic effect of CPOP-R (substituting pixantrone for doxorubicin) against CHOP-R in untreated, diffuse large B-cell lymphoma (DLBCL) patients. The primary objective was to demonstrate non-inferiority of CPOP-R by complete response/complete response unconfirmed (CR/CRu) rate.
RESULTS


The CR/CRu rate for CPOP-R was 75% versus 84% for CHOP-R. Three-year overall survival was lower for CPOP-R (69% versus 85%) (P = 0.029). Median progression-free survival (PFS) was not reached for CPOP-R and was 40 months for CHOP-R [HR 95% confidence interval (CI) = 1.02 (0.60, 1.76), P = 0.934]. Fewer CPOP-R patients developed congestive heart failure (CHF) (0% versus 6%, P = 0.120), ≥ 20% declines in ejection fraction (2% versus 17%, P = 0.004), or elevations in troponin-T (P = 0.003).
CONCLUSIONS


CPOP-R is an active regimen with modestly lower response rates than CHOP-R but similar PFS and event-free survival. This study demonstrates a substantially lower cardiotoxicity of pixantrone compared with doxorubicin when used as first-line therapy in DLBCL.",2013,Three-year overall survival was lower for CPOP-R (69% versus 85%) (P = 0.029).,"['untreated, diffuse large B-cell lymphoma (DLBCL) patients', 'diffuse large B-cell lymphoma']","['doxorubicin', 'pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R', 'CPOP-R (substituting pixantrone for doxorubicin']","['CR/CRu rate for CPOP-R', 'overall survival', 'ejection fraction', 'Median progression-free survival (PFS', 'congestive heart failure (CHF', 'non-inferiority of CPOP-R by complete response/complete response unconfirmed (CR/CRu) rate']","[{'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0253355', 'cui_str': 'pixantrone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.123061,Three-year overall survival was lower for CPOP-R (69% versus 85%) (P = 0.029).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Herbrecht', 'Affiliation': 'Department of Oncology and Hematology, Hôpital de Hautepierre, Strasbourg, France. Electronic address: raoul.herbrecht@chru-strasbourg.fr.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cernohous', 'Affiliation': 'Cell Therapeutics, Inc., Seattle, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'Department of Internal Medicine 1, Klinikum der Universität zu Köln, Köln, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'Hematology Service, Hôtel Dieu 1, Nantes, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Macdonald', 'Affiliation': 'Division of Hematology, Queen Elizabeth II Health Sciences Centre, Halifax, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Machida', 'Affiliation': 'Cell Therapeutics, Inc., Seattle, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Myint', 'Affiliation': 'Cell Therapeutics, Inc., Seattle, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saleh', 'Affiliation': 'Department of Oncology/Hematology, Sharp HealthCare, San Diego, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Cell Therapeutics, Inc., Seattle, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Oncology and Hematology, Klinikum Nürnberg Nord Medizinische Klinik 5, Nürnberg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van der Jagt', 'Affiliation': 'Clinical Haematology, Ottawa Hospital, Ottawa, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt289']
3395,21940785,"Celecoxib can prevent capecitabine-related hand-foot syndrome in stage II and III colorectal cancer patients: result of a single-center, prospective randomized phase III trial.","BACKGROUND


Hand-foot syndrome (HFS) is the most common adverse event induced by capecitabine. Some clinicians think that HFS is a type of inflammation limited to the hands and feet and can be prevented with a COX-2 inhibitor (celecoxib).
METHODS


We designed a single-center, prospective randomized clinical trial to test the hypothesis. From August 2008 to December 2010, stage II and III colorectal cancer patients receiving capecitabine-based chemotherapy enrolled in the trial voluntarily. All patients were divided randomly into two groups treated with or without celecoxib. All adverse events were recorded.
RESULTS


Grade 1 and grade 2 HFS were more common in the capecitabine group than in the capecitabine/celecoxib group (74.6% versus 57.4%, P = 0.034, 29.6% versus 14.7% P = 0.035). The use of celecoxib (P < 0.001, P = 0.003) and the level of dihydropyrimidine dehydrogenase (P = 0.048, P = 0.014) affected the incidence of grade 1 and 2 HFS, as determined by log-rank analysis. Multivariate Cox proportional hazards regression analysis indicated that the use of celecoxib was the only factor that affected the incidence of ≥ grade 1 HFS [Hazard Ratio (HR): 0.556, P = 0.001] and ≥ grade 2 HFS (HR: 0.414, P = 0.005).
CONCLUSIONS


Celecoxib can be used effectively and safely to prevent capecitabine-related HFS.",2012,"RESULTS


Grade 1 and grade 2 HFS were more common in the capecitabine group than in the capecitabine/celecoxib group (74.6% versus 57.4%, P = 0.034, 29.6% versus 14.7% P = 0.035).","['stage II and III colorectal cancer patients', 'From August 2008 to December 2010, stage II and III colorectal cancer patients receiving capecitabine-based chemotherapy enrolled in the trial voluntarily']","['Celecoxib', 'celecoxib', 'capecitabine', 'capecitabine/celecoxib', 'HFS']",['level of dihydropyrimidine dehydrogenase'],"[{'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0058126', 'cui_str': 'Dihydrouracil Dehydrogenase (NADP)'}]",,0.0992739,"RESULTS


Grade 1 and grade 2 HFS were more common in the capecitabine group than in the capecitabine/celecoxib group (74.6% versus 57.4%, P = 0.034, 29.6% versus 14.7% P = 0.035).","[{'ForeName': 'R X', 'Initials': 'RX', 'LastName': 'Zhang', 'Affiliation': ""Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Wu', 'Affiliation': ""Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Wan', 'Affiliation': ""Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Z H', 'Initials': 'ZH', 'LastName': 'Lu', 'Affiliation': ""Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Kong', 'Affiliation': ""Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Z Z', 'Initials': 'ZZ', 'LastName': 'Pan', 'Affiliation': ""Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China. Electronic address: chengong@sysucc.org.cn.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr400']
3396,32020032,Timing of exercise for muscle strength and physical function in men initiating ADT for prostate cancer.,"BACKGROUND


Androgen deprivation therapy (ADT) in men with prostate cancer (PCa) results in adverse effects, including reduced muscle strength and physical function, potentially compromising daily functioning. We examined whether it was more efficacious to commence exercise at the onset of ADT rather than later in treatment to counter declines in strength and physical function.
METHODS


One-hundred-and-four men with PCa (68.3 ± 7.0 years) initiating ADT were randomised to immediate exercise (IMX, n = 54) or delayed exercise (DEL, n = 50) for 12 months. IMX comprised 6 months of supervised resistance/aerobic/impact exercise initiated at the onset of ADT with a 6-month follow-up. DEL comprised 6 months of usual care followed by 6 months of resistance/aerobic/impact exercise. Upper and lower body muscle strength and physical function were assessed at baseline, 6 and 12 months.
RESULTS


There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively. From 7 to 12 months, DEL increased in all strength measures (P < 0.001), with no differences between groups at 12 months. Similarly, physical function improved (P < 0.001) in IMX compared with DEL at 6 months for the 6-m fast walk (-0.2, 95% CI -0.3 to -0.1 s), 400-m walk (-9.7, -14.8 to -4.6 s), stair climb (-0.4, -0.6 to -0.2 s) and chair rise (-1.0, -1.4 to -0.7 s), with no differences between groups by 12 months, except for the 6-m fast walk (P < 0.001).
CONCLUSION


Exercise either at the onset or after 6 months of ADT preserves/enhances muscle strength and physical function. However, to avoid initial treatment-related adverse effects on strength and function, exercise therapy should be implemented with initiation of ADT.",2020,"There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively.","['men with prostate cancer (PCa', 'One-hundred-and-four men with PCa (68.3\u2009±\u20097.0 years) initiating ADT', 'men initiating ADT for prostate cancer']","['immediate exercise (IMX, n\u2009=\u200954) or delayed exercise (DEL', 'IMX', 'Androgen deprivation therapy (ADT']","['strength measures', 'physical function', 'chair rise', 'stair climb', 'leg press, seated row and chest press strength', 'Upper and lower body muscle strength and physical function', 'muscle strength and physical function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",104.0,0.0802218,"There was a significant difference for all strength measures at 6 months favouring IMX (P < 0.001), with net differences in leg press, seated row and chest press strength of 19.9 kg (95% CI, 12.3-27.5 kg), 5.6 kg (3.8-7.4 kg) and 4.3 kg (2.7-5.8 kg), respectively.","[{'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia. r.newton@ecu.edu.au.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Galvão', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Chambers', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gardiner', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Dickon', 'Initials': 'D', 'LastName': 'Hayne', 'Affiliation': 'UWA Medical School, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Taaffe', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0200-z']
3397,31264101,Moderators of Cognitive Therapy and Bright Light Therapy Effects on Depressive Symptoms in Patients with Breast Cancer.,"BACKGROUND


Cognitive therapy (CT) and bright light therapy (BLT) have been found to be effective to treat depressive symptoms in breast cancer patients. No study has investigated the baseline patients' characteristics that are associated with better outcomes with CT vs. BLT in this population. This study aimed to assess, in breast cancer patients, the moderating role of eight clinical variables on the effects of CT and BLT on depressive symptoms.
METHODS


This is a secondary analysis of a randomized controlled trial conducted in 59 women who received an 8-week CT or BLT and completed questionnaires evaluating depression and possible moderating variables.
RESULTS


Patients benefited more from BLT when they had no prior history of major depressive disorder, higher depression scores on the Hospital Anxiety and Depression Scale (HADS-D) at baseline, a greater initial preference for BLT, and when they received BLT during spring or summer. Patients benefited more from CT when they had a lower initial preference for receiving CT, higher depression scores on the HADS-D, and seasonal depressive symptoms.
CONCLUSIONS


Although replication is needed, findings of this study suggest the existence of different profiles of patients more likely to benefit from CT and BLT.
TRIAL REGISTRATION


NCT01637103 https://clinicaltrials.gov/ct2/show/NCT01637103.",2019,"Patients benefited more from CT when they had a lower initial preference for receiving CT, higher depression scores on the HADS-D, and seasonal depressive symptoms.
","['breast cancer patients', 'Patients with Breast Cancer', '59 women who received an 8-week CT or BLT and completed questionnaires evaluating depression and possible moderating variables']","['Cognitive Therapy and Bright Light Therapy', 'Cognitive therapy (CT) and bright light therapy (BLT', 'CT vs. BLT', 'CT and BLT']","['Hospital Anxiety and Depression Scale (HADS-D', 'Depressive Symptoms']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]","[{'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",59.0,0.0531546,"Patients benefited more from CT when they had a lower initial preference for receiving CT, higher depression scores on the HADS-D, and seasonal depressive symptoms.
","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Desautels', 'Affiliation': 'School of Psychology, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'School of Psychology, Université Laval, Québec, QC, Canada. josee.savard@psy.ulaval.ca.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ivers', 'Affiliation': 'School of Psychology, Université Laval, Québec, QC, Canada.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09802-6']
3398,30224341,"MAVERICC, a Randomized, Biomarker-stratified, Phase II Study of mFOLFOX6-Bevacizumab versus FOLFIRI-Bevacizumab as First-line Chemotherapy in Metastatic Colorectal Cancer.","PURPOSE


MAVERICC compared the efficacy and safety of modified leucovorin/5-fluorouracil/oxaliplatin plus bevacizumab (mFOLFOX6-BV) with leucovorin/5-fluorouracil/irinotecan plus bevacizumab (FOLFIRI-BV) in patients with previously untreated metastatic colorectal cancer (mCRC). Patients and Methods:  MAVERICC was a global, randomized, open-label, phase II study. Primary objectives were to assess associations between (i) excision repair cross-complementing 1 (ERCC1) expression with progression-free survival (PFS), and (ii) plasma VEGF A (VEGF-A) with PFS in patients with previously untreated mCRC receiving mFOLFOX6-BV or FOLFIRI-BV. Before randomization, patients were stratified by tumoral ERCC1/β-actin mRNA expression level and region.
RESULTS


Of 376 enrolled patients, 188 each received mFOLFOX6-BV and FOLFIRI-BV. PFS and overall survival (OS) were comparable between FOLFIRI-BV and mFOLFOX6-BV, with numerically higher PFS [HR = 0.79; 95% CI (confidence interval): 0.61-1.01;  P  = 0.06] and OS (HR = 0.76; 95% CI: 0.56-1.04;  P  = 0.09) observed for FOLFIRI-BV. In the high ERCC1 subgroup, PFS and OS were comparable between treatment groups (PFS, HR = 0.84; 95% CI: 0.56-1.26;  P  = 0.40; OS, HR = 0.80; 95% CI: 0.51-1.26;  P  = 0.33). Across treatment groups, high plasma VEGF-A levels (>5.1 pg/mL) were observed with shorter PFS (HR = 1.19; 95% CI: 0.93-1.53;  P  = 0.17) and significantly shorter OS (HR = 1.64; 95% CI: 1.20-2.24;  P  < 0.01) versus low levels (≤5.1 pg/mL). Safety findings for FOLFIRI-BV or mFOLFOX6-BV were comparable with those reported previously.
CONCLUSIONS


First-line FOLFIRI-BV and mFOLFOX6-BV had comparable PFS and OS, similar to results in patients with high baseline tumor ERCC1 levels. There were no new safety signals with these bevacizumab-containing regimens.",2019,"PFS and overall survival (OS) were comparable between FOLFIRI-BV and mFOLFOX6-BV, with numerically higher PFS [HR = 0.79; 95% CI (confidence interval): 0.61-1.01;  P  = 0.06] and OS (HR = 0.76; 95% CI: 0.56-1.04;  P  = 0.09) observed for FOLFIRI-BV.","['376 enrolled patients, 188', 'Metastatic Colorectal Cancer', 'patients with previously untreated mCRC receiving mFOLFOX6-BV or FOLFIRI-BV', 'patients with previously untreated metastatic colorectal cancer (mCRC']","['modified leucovorin/5-fluorouracil/oxaliplatin plus bevacizumab (mFOLFOX6-BV) with leucovorin/5-fluorouracil/irinotecan plus bevacizumab (FOLFIRI-BV', 'mFOLFOX6-Bevacizumab versus FOLFIRI-Bevacizumab', 'bevacizumab']","['PFS and overall survival (OS', 'associations between (i) excision repair cross-complementing 1 (ERCC1) expression with progression-free survival (PFS), and (ii) plasma VEGF A (VEGF-A) with PFS', 'high plasma VEGF-A levels', 'PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0015249', 'cui_str': 'Excision Repair'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0009499', 'cui_str': 'Complement C1'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",376.0,0.218652,"PFS and overall survival (OS) were comparable between FOLFIRI-BV and mFOLFOX6-BV, with numerically higher PFS [HR = 0.79; 95% CI (confidence interval): 0.61-1.01;  P  = 0.06] and OS (HR = 0.76; 95% CI: 0.56-1.04;  P  = 0.09) observed for FOLFIRI-BV.","[{'ForeName': 'Aparna R', 'Initials': 'AR', 'LastName': 'Parikh', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital, Boston, Massachusetts. Aparna.Parikh@MGH.HARVARD.EDU.'}, {'ForeName': 'Fa-Chyi', 'Initials': 'FC', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology/Oncology, University of California Irvine, Irvine, California.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Yau', 'Affiliation': 'Evidence Generation, Biometrics, Genentech, Inc., US Medical Affairs, South San Francisco, California.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Koh', 'Affiliation': 'Department of Medical Oncology, Southern California Permanente Group, Bellflower, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Knost', 'Affiliation': 'Department of Hematology/Oncology, Illinois Cancer Center, Peoria, Illinois.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bosanac', 'Affiliation': 'Global Product Development Medical Affairs-PDMA, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Choong', 'Affiliation': 'Genentech, Inc., US Medical Affairs, South San Francisco, California.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Scappaticci', 'Affiliation': 'BioOncology, Genentech, Inc., US Medical Affairs, South San Francisco, California.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mancao', 'Affiliation': 'Oncology Biomarker Development, Genentech Inc., Basel, Switzerland.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Norris Comprehensive Cancer Center, Keck School of Medicine, Department of Medicine, University of Southern California, Los Angeles, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-1221']
3399,31009939,Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study.,"Background


Identifying reliable predictors of long-term weight loss (LTWL) could lead to improved weight management.
Objective


To identify some predictors of LTWL.
Design


The DPP (Diabetes Prevention Program) was a randomized controlled trial that compared weight loss with metformin, intensive lifestyle intervention (ILS), or placebo. Its Outcomes Study (DPPOS) observed patients after the masked treatment phase ended. (ClinicalTrials.gov: NCT00004992 and NCT00038727).
Setting


27 DPP and DPPOS clinics.
Participants


Of the 3234 randomly assigned participants, 1066 lost at least 5% of baseline weight in the first year and were followed for 15 years.
Measurements


Treatment assignment, personal characteristics, and weight.
Results


After 1 year, 289 (28.5%) participants in the metformin group, 640 (62.6%) in the ILS group, and 137 (13.4%) in the placebo group had lost at least 5% of their weight. After the masked treatment phase ended, the mean weight loss relative to baseline that was maintained between years 6 and 15 was 6.2% (95% CI, 5.2% to 7.2%) in the metformin group, 3.7% (CI, 3.1% to 4.4%) in the ILS group, and 2.8% (CI, 1.3% to 4.4%) in the placebo group. Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group.
Limitation


Post hoc analysis; examination of nonrandomized subsets of randomized groups after year 1.
Conclusion


Among persons with weight loss of at least 5% after 1 year, those originally randomly assigned to metformin had the greatest loss during years 6 to 15. Older age and the amount of weight initially lost were the most consistent predictors of LTWL maintenance.
Primary Funding Source


National Institutes of Health.",2019,"Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group.
","['Participants\n\n\nOf the 3234 randomly assigned participants, 1066 lost at least 5% of baseline weight in the first year and were followed for 15 years', 'persons with weight loss of at least 5% after 1 year']","['Metformin or Lifestyle Intervention', 'placebo', 'metformin', 'metformin, intensive lifestyle intervention (ILS), or placebo']","['weight loss', 'personal characteristics, and weight', 'mean weight loss relative', 'fasting plasma glucose levels']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3234.0,0.102366,"Independent predictors of LTWL included greater weight loss in the first year in all groups, older age and continued metformin use in the metformin group, older age and absence of either diabetes or a family history of diabetes in the ILS group, and higher fasting plasma glucose levels at baseline in the placebo group.
","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana (J.W.A., K.M.G.).'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (E.M.V.).'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, Maryland (S.L.E.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona (W.C.K.).'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Dabelea', 'Affiliation': 'Colorado School of Public Health, Aurora, Colorado (D.D.).'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Boyko', 'Affiliation': 'Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, Washington (E.J.B.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, New York (X.P.).'}, {'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Kalyani', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland (R.R.K.).'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Lund University Diabetes Centre, Skåne University Hospital, Malmö, Sweden (P.W.F.).'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Srikanthan', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California (P.S.).'}, {'ForeName': 'Kishore M', 'Initials': 'KM', 'LastName': 'Gadde', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana (J.W.A., K.M.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M18-1605']
3400,31704268,Do Splints Play a Role in the Management of Condylar Postfracture Syndrome After Mandibular Angle Fractures?-A Randomized Controlled Clinical Trial.,"PURPOSE


Fractures of the mandibular angle can result in condylar postfracture syndrome (CPFS) due to indirect injury to the condylar region. Studies evaluating early intervention for CPFS are lacking. In the present study, we evaluated the efficacy of interocclusal splint therapy for the prevention and early management of CPFS.
PATIENTS AND METHODS


A prospective randomized controlled clinical trial was designed and included patients who required open reduction and internal fixation for a unilateral angle fracture. The patients were divided into 2 groups. The study group received interocclusal splints postoperatively and the control group did not receive such splints. The patients were followed up at 2 weeks and 1, 2, and 3 months. The primary outcome measure was the presence or absence of CPFS after 3 months. CPFS was defined as the presence of any 1 of the clinical signs of temporomandibular joint dysfunction. The secondary outcomes included the mean pain scores and degree of mouth opening, which were evaluated at each follow-up visit.
RESULTS


The study included 40 patients, with 20 patients each randomized to the study and control groups. At the end of 3 months, CPFS was present in 2 patients in the study group and in all 20 patients in the control group. The mean pain scores were significantly lower in the study group than in the control group, and the mean mouth opening was significantly greater.
CONCLUSIONS


The use of interocclusal splints was found to be effective in the prevention and early management of CPFS. The use of splints also resulted in decreased pain and an improved mandibular mouth opening.",2020,The use of interocclusal splints was found to be effective in the prevention and early management of CPFS.,"['patients who required open reduction and internal fixation for a unilateral angle fracture', 'Condylar Postfracture Syndrome', '40 patients, with 20 patients each randomized to the study and control groups']","['interocclusal splints postoperatively and the control group did not receive such splints', 'interocclusal splint therapy']","['decreased pain and an improved mandibular mouth opening', 'mean pain scores', 'CPFS', 'mean pain scores and degree of mouth opening', 'mean mouth opening', 'presence or absence of CPFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0204861', 'cui_str': 'Application of splint (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]",40.0,0.0398079,The use of interocclusal splints was found to be effective in the prevention and early management of CPFS.,"[{'ForeName': 'Vikranth', 'Initials': 'V', 'LastName': 'Prathap', 'Affiliation': 'Consultant and Private Practitioner, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'Swetha', 'Initials': 'S', 'LastName': 'Tarun', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'Logitha Sri', 'Initials': 'LS', 'LastName': 'S', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'Sasikala', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram, Chennai, India. Electronic address: sasiomfs@gmail.com.'}, {'ForeName': 'Elavenil', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}, {'ForeName': 'Krishnakumar Raja', 'Initials': 'KR', 'LastName': 'Vb', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram, Chennai, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.028']
3401,32015491,"Clinical significance of TP53, BIRC3, ATM and MAPK-ERK genes in chronic lymphocytic leukaemia: data from the randomised UK LRF CLL4 trial.","Despite advances in chronic lymphocytic leukaemia (CLL) treatment, globally chemotherapy remains a central treatment modality, with chemotherapy trials representing an invaluable resource to explore disease-related/genetic features contributing to long-term outcomes. In 499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations. After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1). Mutations beyond Sanger resolution (<12% VAF) were observed in all genes, with KRAS mutations principally composed of these low VAF variants. Firstly, employing orthogonal approaches to confirm <12% VAF TP53 mutations, we assessed the clinical impact of TP53 clonal architecture. Whilst ≥ 12% VAF TP53mut cases were associated with reduced PFS and OS, we could not demonstrate a difference between <12% VAF TP53 mutations and either wild type or ≥12% VAF TP53mut cases. Secondly, we identified biallelic BIRC3 lesions (mutation and deletion) as an independent marker of inferior PFS and OS. Finally, we observed that mutated MAPK-ERK genes were independent markers of poor OS in multivariate survival analysis. In conclusion, our study supports using targeted resequencing of expanded gene panels to elucidate the prognostic impact of gene mutations.",2020,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","['chronic lymphocytic leukaemia (CLL', 'chronic lymphocytic leukaemia', '499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations']",[],"['PFS and OS', 'Mutations beyond Sanger resolution', 'biallelic BIRC3 lesions (mutation and deletion']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",[],"[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]",,0.0594031,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Clifford', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parker', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stec-Dziedzic', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Larrayoz', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zadie', 'Initials': 'Z', 'LastName': 'Davis', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalyayil', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Colins', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robbe', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vavoulis', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Carr', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morilla', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Else', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Renata J', 'Initials': 'RJ', 'LastName': 'Walewska', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Speight', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stankovic', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Services, IBR West, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cragg', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catovsky', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Oscier', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Matthew J J', 'Initials': 'MJJ', 'LastName': 'Rose-Zerilli', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. jcs@soton.ac.uk.'}]",Leukemia,['10.1038/s41375-020-0723-2']
3402,31239321,Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use.,"PURPOSE


Cetuximab, which modulates immune responses, may affect the efficacy of subsequent immunotherapy. Here, we assessed outcomes with nivolumab, by prior cetuximab exposure, in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinum-containing chemotherapy.
PATIENTS AND METHODS


In the randomized, open-label, phase III CheckMate 141 trial, patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure. The primary endpoint was overall survival (OS); additional endpoints were progression-free survival, objective response rate, and safety.
RESULTS


In patients with prior cetuximab exposure, the median OS was 7.1 months with nivolumab versus 5.1 months with IC (HR, 0.84; 95% CI, 0.62-1.15); OS benefit with nivolumab was maintained across most demographic subgroups. In patients without prior cetuximab exposure, the median OS was 8.2 months with nivolumab versus 4.9 months with IC (HR, 0.52; 95% CI, 0.35-0.77); OS benefit with nivolumab was maintained across patient baseline subgroups including tumor programmed death ligand 1 (PD-L1) expression (<1% or ≥1%). Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups.
CONCLUSIONS


Nivolumab appeared to improve efficacy versus IC regardless of prior cetuximab use, supporting its use in patients with R/M SCCHN with or without prior cetuximab exposure. The reduction in risk of death with nivolumab compared with IC was greater in patients without prior cetuximab exposure versus with prior cetuximab exposure.",2019,"Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups.
","['patients with R/M SCCHN with or without prior cetuximab exposure', 'patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinum-containing chemotherapy', 'Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck']","['Nivolumab', ""nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure""]","['risk of death', 'overall survival (OS); additional endpoints were progression-free survival, objective response rate, and safety', 'median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0280574,"Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups.
","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'Departments of Otolaryngology and Immunology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania. ferrisrl@upmc.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Medical Oncology, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Medical Oncology, Gustave Roussy, Villejuif Cedex, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'Radiotherapy and Imaging, Royal Marsden/The Institute of Cancer Research, National Institute of Health Research Biomedical Research Center, London, United Kingdom.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Medical Oncology, Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'Medical Oncology, University of Chicago Medical Center, Chicago, Illinois.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Shanmugasundaram', 'Initials': 'S', 'LastName': 'Ramkumar', 'Affiliation': 'Clinical Oncology, University Hospital Southampton/NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'Head and Neck/Cutaneous/Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'Department of Oncology, Hematology, Immuno-oncology and Rheumatology, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Division of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'A Dimitrios', 'Initials': 'AD', 'LastName': 'Colevas', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Concha-Benavente', 'Affiliation': 'Departments of Otolaryngology and Immunology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lynch', 'Affiliation': 'Global Clinical Development, Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Global Biometrics Sciences, Bristol-Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3944']
3403,31865749,Barriers and Facilitators in the Recruitment and Retention of More Than 250 Small Independent Primary Care Practices for EvidenceNOW.,"Few studies have examined factors that facilitate recruitment of small independent practices (SIPs) (<5 full-time clinicians) to participate in research and methods for optimizing retention. The authors analyzed qualitative data (eg, recruiter's field notes and diary entries, provider interviews) to identify barriers and facilitators encountered in recruiting and retaining 257 practices in HealthyHearts New York City (NYC). This study was a stepped-wedge randomized controlled trial that took place 2015 through 2018 across 5 boroughs in NYC. Three main factors facilitated rapid recruitment: (1) a prior well-established relationship with the local health department, (2) alignment of project goals with practice priorities, and (3) providing appropriate monetary incentives. Retention was facilitated through similar mechanisms and an ongoing multifaceted communication strategy. This article identifies specific strategies that enhance recruitment of SIPs and fills gaps in knowledge about factors that influence retention in the context of a design that requires waiting to receive the intervention.",2020,Few studies have examined factors that facilitate recruitment of small independent practices (SIPs) (<5 full-time clinicians) to participate in research and methods for optimizing retention.,['took place 2015 through 2018 across 5 boroughs in NYC'],['barriers and facilitators encountered in recruiting and retaining 257 practices in HealthyHearts New York City (NYC'],[],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]",[],5.0,0.112668,Few studies have examined factors that facilitate recruitment of small independent practices (SIPs) (<5 full-time clinicians) to participate in research and methods for optimizing retention.,"[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Cuthel', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rogers', 'Affiliation': 'New York University School of Medicine, New York, NY.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Daniel', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Queens, NY.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Carroll', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Queens, NY.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Pham-Singer', 'Affiliation': 'New York City Department of Health and Mental Hygiene, Queens, NY.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'New York University School of Medicine, New York, NY.'}]",American journal of medical quality : the official journal of the American College of Medical Quality,['10.1177/1062860619893422']
3404,31792947,GP-Led Deprescribing in Community-Living Older Australians: An Exploratory Controlled Trial.,"OBJECTIVE


To assess feasibility, effectiveness, and safety of a multifaceted general practitioner (GP) led intervention to reduce potentially inappropriate polypharmacy in community-living older people.
DESIGN


Pragmatic, controlled, pre-post design.
SETTING


Five general practices in southeast Queensland, Australia.
PARTICIPANTS


Ten GPs from three practices, two pharmacists, and 78 patients comprised the intervention group, and 10 GPs from two practices and 67 patients comprised the usual care group. Patients were aged 65 years or older, receiving five or more regularly prescribed medicines, and capable of participating in telephone interviews in English.
INTERVENTION


A 5-hour interactive deprescribing training workshop for clinicians; an extended deprescribing consultation between GPs and enrolled patients, entailing a comprehensive review of their medicines using a standardized software template codesigned by GPs; and comprehensive medicine review by a pharmacist, at the GP's discretion.
OUTCOME MEASURES


Primary outcome was mean difference in number of regular medicines deprescribed (ie, ceased or dose reduced) per patient over an 18-week follow-up period. Medicine-specific and patient-reported outcomes, safety, and process measures were also evaluated.
RESULTS


At study completion, mean (SD) number of regular medicines deprescribed per patient was 0.99 (1.23) in the intervention group vs 0.43 (0.84) in the usual care group, equaling a mean difference of 0.55 (95% confidence interval = -0.90 to -0.21; P = .002). Crude totals showed 77 of 649 (11.9%) vs 29 of 571 (5.1%) regular medicines deprescribed in intervention and usual care groups, respectively (P < .001). Supplements, gastric acid suppressants, statins, oral hypoglycemics, and diuretics were medicine classes more frequently deprescribed. There were no statistically significant between-group differences in numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life. A subset of intervention patients reported greater certainty in the necessity and appropriateness of their medicines at study end.
CONCLUSION


The deprescribing intervention appears feasible, was modestly effective, and was not associated with any major safety events. J Am Geriatr Soc 68:403-410, 2020.",2020,"There were no statistically significant between-group differences in numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life.","['community-living older people', 'Ten GPs from three practices, two pharmacists, and 78 patients comprised the intervention group, and 10 GPs from two practices and 67 patients comprised the usual care group', 'Five general practices in southeast Queensland, Australia', 'Community-Living Older Australians', 'Patients were aged 65\u2009years or older, receiving five or more regularly prescribed medicines, and capable of participating in telephone interviews in English']","['GP-Led Deprescribing', 'multifaceted general practitioner (GP) led intervention']","['mean (SD) number of regular medicines', 'numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life', 'mean difference in number of regular medicines deprescribed (ie, ceased or dose reduced) per patient']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",5.0,0.211871,"There were no statistically significant between-group differences in numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Centre of Research Excellence in Quality and Safety in Integrated Primary-Secondary Care, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Freeman', 'Affiliation': 'School of Pharmacy, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Centre of Research Excellence in Quality and Safety in Integrated Primary-Secondary Care, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Scott', 'Affiliation': 'Centre of Research Excellence in Quality and Safety in Integrated Primary-Secondary Care, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16273']
3405,32020438,"A Canadian cancer trials group phase IB study of durvalumab (anti-PD-L1) plus tremelimumab (anti-CTLA-4) given concurrently or sequentially in patients with advanced, incurable solid malignancies.","Background The IND.226 study was a phase Ib study to determine the recommended phase II dose of durvalumab + tremelimumab in combination with standard platinum-doublet chemotherapy. Sequential administration of multiple agents increases total chair time adding costs overall and inconvenience for patients. This cohort of the IND.226 study evaluated the safety and tolerability of durvalumab + tremelimumab given either sequentially (SEQ) or concurrently (CON). Methods Patients with advanced solid tumours were enrolled and randomised to either SEQ tremelimumab 75 mg IV over 1 h followed by durvalumab 1500 mg IV over 1 h q4wks on the same day, or CON administration over 1 h. The serum pharmacokinetic profile of SEQ versus CON of durvalumab and tremelimumab administration was also evaluated. Results 14 patients either received SEQ (n = 7pts) or CON (n = 7 pts). There were no infusion related reactions. Drug related adverse events (AEs) were mainly low grade and manageable, and comparable in frequency between SEQ/CON- fatigue (43%/57%), rash (43%/43%), pruritus (43%/29%) and nausea (14%/29%). One patient in each cohort discontinued treatment due to toxicity. The PK profiles of durvalumab and tremelimumab were similar between CON and SEQ, and to historical reference data. Conclusions Concurrent administration of durvalumab and tremelimumab over 1 h is safe with a comparable PK profile to sequential administration.",2020,"Drug related adverse events (AEs) were mainly low grade and manageable, and comparable in frequency between SEQ/CON- fatigue (43%/57%), rash (43%/43%), pruritus (43%/29%) and nausea (14%/29%).","['14 patients either received', 'patients with advanced, incurable solid malignancies', 'patients', 'Methods Patients with advanced solid tumours']","['tremelimumab', 'durvalumab 1500\xa0mg IV over 1\xa0h q4wks on the same day, or CON administration over 1\xa0h', 'durvalumab and tremelimumab', 'SEQ', 'durvalumab (anti-PD-L1) plus tremelimumab (anti-CTLA-4', 'CON', 'durvalumab + tremelimumab given either sequentially (SEQ) or concurrently (CON', 'durvalumab + tremelimumab in combination with standard platinum-doublet chemotherapy']","['safety and tolerability', 'serum pharmacokinetic profile of SEQ', 'frequency between SEQ/CON- fatigue', 'pruritus', 'nausea', 'rash', 'toxicity', 'total chair time adding costs overall and inconvenience']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",14.0,0.0434464,"Drug related adverse events (AEs) were mainly low grade and manageable, and comparable in frequency between SEQ/CON- fatigue (43%/57%), rash (43%/43%), pruritus (43%/29%) and nausea (14%/29%).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nehra', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L3N6, Canada.""}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Bradbury', 'Affiliation': 'Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Ellis', 'Affiliation': 'Department of Oncology - Division of Medical Oncology, Juravinski Cancer Centre, Hamilton, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Laskin', 'Affiliation': 'Division of Medical Oncology, BCCA Vancouver Cancer Centre, Vancouver, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, BCCA Vancouver Cancer Centre, Vancouver, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hao', 'Affiliation': 'Department of Oncology - Section of Medical Oncology, Tom Baker Cancer Centre University of Calgary, Calgary, Canada.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Juergens', 'Affiliation': 'Department of Oncology - Division of Medical Oncology, Juravinski Cancer Centre, Hamilton, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Goss', 'Affiliation': 'Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wheatley-Price', 'Affiliation': 'Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Hotte', 'Affiliation': 'Department of Oncology - Division of Medical Oncology, Juravinski Cancer Centre, Hamilton, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'Division of Medical Oncology, BCCA Vancouver Cancer Centre, Vancouver, Canada.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Tinker', 'Affiliation': 'Division of Medical Oncology, BCCA Vancouver Cancer Centre, Vancouver, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brown-Walker', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L3N6, Canada.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gauthier', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L3N6, Canada.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L3N6, Canada.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Clinical Pharmacology & Safety Sciences, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Clinical Pharmacology & Safety Sciences, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Seymour', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L3N6, Canada. lseymour@ctg.queensu.ca.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Smoragiewicz', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L3N6, Canada.""}]",Investigational new drugs,['10.1007/s10637-020-00904-7']
3406,32006007,Amino Acid Digestibility of Extruded Chickpea and Yellow Pea Protein is High and Comparable in Moderately Stunted South Indian Children with Use of a Dual Stable Isotope Tracer Method.,"BACKGROUND


Legumes are an excellent plant source of the limiting indispensable amino acid (IAA) lysine in vegetarian, cereal-based diets. However, their digestibility is poor largely because of their antiprotease content. Extrusion can enhance digestibility by inactivating trypsin inhibitors and thus potentially improve the protein quality of legumes.
OBJECTIVE


We measured the digestibility of extruded chickpea and yellow pea protein with use of a dual stable isotope method in moderately stunted South Indian primary school children.
METHODS


Twenty-eight moderately stunted children (height-for-age z scores <-2.0 SD and >-3.0 SD) aged 6-11 y from low to middle socioeconomic status were randomly assigned to receive a test protein (extruded intrinsically [2H]-labeled chickpea or yellow pea) along with a standard of U-[13C]-spirulina protein to measure amino acid (AA) digestibility with use of a dual stable isotope method. Individual AA digestibility in the test protein was calculated by the ratios of AA enrichments in the test protein to the standard protein in the food and their appearance in blood plasma collected at 6 and 6.5 h during the experiment, representing a plateau state.
RESULTS


The mean AA digestibility of extruded chickpea and yellow pea protein in moderately stunted children (HAZ; -2.86 to -1.2) was high and similar in both extruded test proteins (89.0% and 88.0%, respectively, P = 0.83). However, lysine and proline digestibilities were higher in extruded chickpea than yellow pea (79.2% compared with 76.5% and 75.0% compared with 72.0%, respectively, P < 0.02).
CONCLUSION


Extruded chickpea and yellow pea protein had good IAA digestibility in moderately stunted children, which was 20% higher than an earlier report of their digestibility when pressure-cooked, measured by the same method in adults. Higher digestibility of lysine and proline highlights better retention of these AA in chickpea during extrusion-based processing. Extrusion might be useful for developing high-quality protein foods from legumes. This trial was registered at www.ctri.nic.in as CTRI/2018/03/012439.",2020,"Extruded chickpea and yellow pea protein had good IAA digestibility in moderately stunted children, which was 20% higher than an earlier report of their digestibility when pressure-cooked, measured by the same method in adults.","['moderately stunted South Indian primary school children', 'Moderately Stunted South Indian Children', 'Twenty-eight moderately stunted children (height-for-age z scores <-2.0 SD and >-3.0 SD', 'aged 6-11 y from low to middle socioeconomic status']","['Extruded chickpea and yellow pea protein', 'test protein (extruded intrinsically [2H]-labeled chickpea or yellow pea) along with a standard of U-[13C]-spirulina protein to measure amino acid (AA) digestibility with use of a dual stable isotope method']","['lysine and proline digestibilities', 'Individual AA digestibility', 'IAA digestibility', 'mean AA digestibility of extruded chickpea and yellow pea protein']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]","[{'cui': 'C0950052', 'cui_str': 'Chickpea'}, {'cui': 'C0221205', 'cui_str': 'Yellow color (qualifier value)'}, {'cui': 'C3535674', 'cui_str': 'Pea Proteins'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0532245', 'cui_str': 'Extrude'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0024337', 'cui_str': 'L-lysine'}, {'cui': 'C0033382', 'cui_str': 'L-proline'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0950052', 'cui_str': 'Chickpea'}, {'cui': 'C0221205', 'cui_str': 'Yellow color (qualifier value)'}, {'cui': 'C3535674', 'cui_str': 'Pea Proteins'}]",28.0,0.0229697,"Extruded chickpea and yellow pea protein had good IAA digestibility in moderately stunted children, which was 20% higher than an earlier report of their digestibility when pressure-cooked, measured by the same method in adults.","[{'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Devi', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Aneesia', 'Initials': 'A', 'LastName': 'Varkey', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Dharmar', 'Affiliation': 'Betty Irene Moore School of Nursing and the Department of Pediatrics, University of California, Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Roberta R', 'Initials': 'RR', 'LastName': 'Holt', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'United States Department of Agriculture, Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Sheshshayee', 'Affiliation': 'Department of Crop Physiology, University of Agricultural Sciences, Bangalore, India.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Preston', 'Affiliation': 'Scottish Universities Environmental Research Centre, East Kilbride, UK.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Keen', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Department of Physiology, St. John's Medical College, St. John's National Academy of Health Sciences, Bangalore, India.""}]",The Journal of nutrition,['10.1093/jn/nxaa004']
3407,30935742,Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials.,"BACKGROUND


The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.
METHODS


Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.
RESULTS


Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.
CONCLUSIONS


No safety concerns arose, supporting the favorable benefit-risk profile of RZV.",2019,"Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.
","['Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years', 'herpes zoster in adults']","['RZV or placebo', 'placebo', 'recombinant zoster vaccine (RZV', 'Placebo', 'adjuvanted recombinant zoster vaccine']","['occurrence of overall SAEs', 'unsolicited AEs', 'Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs', 'Solicited and unsolicited adverse events (AEs', 'transient injection site and solicited systemic reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",,0.548038,"Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.
","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López-Fauqued', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: marta.x.lopez-fauqed@gsk.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campora', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: laura.e.campora@gsk.com.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Delannois', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: frederique.x.delannois@gsk.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium. Electronic address: mohamed.s.elidrissi@gsk.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr.'}, {'ForeName': 'Ferdinandus J', 'Initials': 'FJ', 'LastName': 'De Looze', 'Affiliation': 'AusTrials Pty Ltd, Sherwood and School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: f.delooze@trialworks.com.au.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diez-Domingo', 'Affiliation': 'Vaccine Research Unit, Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain. Electronic address: jdiezdomingo@gmail.com.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'GSK, King of Prussia, PA, USA. Electronic address: tch3768@gmail.com.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Lal', 'Affiliation': 'GSK, King of Prussia, PA, USA. Electronic address: himallal@yahoo.com.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'McElhaney', 'Affiliation': 'Health Sciences North Research Institute, Sudbury, Ontario, Canada. Electronic address: jmcelhaney@hsnri.ca.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Shelly.McNeil@nshealth.ca.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Yeo', 'Affiliation': 'School of Medicine, University of Wollongong, Wollongong, Australia. Electronic address: wilf@uow.edu.au.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Tavares-Da-Silva', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: fernanda.tavares@gsk.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.03.043']
3408,32014358,Deprescribing potentially inappropriate medications in memory clinic patients (DePIMM): A feasibility study.,"BACKGROUND


Medication-related problems and inappropriate medication use are prevalent among people attending memory clinics. There have been no deprescribing intervention studies in this setting.
OBJECTIVE


To evaluate the feasibility of a pharmacist-led interdisciplinary deprescribing intervention study in a memory clinic.
METHODS


A pre-post-intervention study conducted at an outpatient memory clinic of an Australian tertiary care public hospital. Participants were English-speaking, community-dwelling patients identified as being at risk of a medication-related problem, or their carers. Participants received a medication review in their home from a consultant pharmacist who collaborated with the patient/carer, memory clinic, general practitioner and community pharmacist to develop a plan for optimising medication use. The primary outcome was feasibility, based on i) proportion of memory clinic patients eligible for the study, ii) proportion of eligible patients who consented, and iii) proportion of pharmacist-identified inappropriate/unnecessary medications that were deprescribed (reduced or ceased) at six months.
RESULTS


One-third of memory clinic patient/carers were eligible (n = 82/238), 61% (n = 50/82) consented to participate. The median (IQR) age of participants who received the intervention (n = 46) was 80.5 (71.5-85.0) years and median (IQR) number of medications was 11 (8.0-13.3). Pharmacists recommended deprescribing 124 medications, and 53 (42.7%) had been ceased or dose-reduced at six months.
CONCLUSION


It was feasible to recruit study participants and deliver a pharmacist-led interdisciplinary deprescribing intervention in this memory clinic setting. A larger, multi-centre study with longer follow-up is needed to confirm effectiveness and clinical outcomes.",2020,"Pharmacists recommended deprescribing 124 medications, and 53 (42.7%) had been ceased or dose-reduced at six months.
","['A pre-post-intervention study conducted at an outpatient memory clinic of an Australian tertiary care public hospital', 'One-third of memory clinic patient/carers were eligible (n\xa0=\xa082/238), 61% (n\xa0=\xa050/82) consented to participate', 'memory clinic patients (DePIMM', 'Participants were English-speaking, community-dwelling patients identified as being at risk of a medication-related problem, or their carers', 'people attending memory clinics']","['medication review in their home from a consultant pharmacist who collaborated with the patient/carer, memory clinic, general practitioner and community pharmacist to develop a plan for optimising medication use', 'pharmacist-led interdisciplinary deprescribing intervention']","['feasibility, based on i) proportion of memory clinic patients eligible for the study, ii) proportion of eligible patients who consented, and iii) proportion of pharmacist-identified inappropriate/unnecessary medications']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C4316447', 'cui_str': 'Consultant pharmacist'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0402003', 'cui_str': 'Community Pharmacists'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}]",,0.072871,"Pharmacists recommended deprescribing 124 medications, and 53 (42.7%) had been ceased or dose-reduced at six months.
","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia; Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Woodward', 'Affiliation': 'Medical and Cognitive Research Unit, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Vivien J', 'Initials': 'VJ', 'LastName': 'Le', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Rohan A', 'Initials': 'RA', 'LastName': 'Elliott', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia; Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia. Electronic address: rohan.elliott@austin.org.au.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.01.010']
3409,31557450,Does Including Dexmedetomidine Improve Outcomes After Intravenous Sedation for Outpatient Dentoalveolar Surgery?,"PURPOSE


Dexmedetomidine represents an intriguing adjunct to outpatient intravenous (IV) sedation owing to its decreased risk of respiratory depression. The purpose of the present study was to measure the incremental effect of incorporating dexmedetomidine (DXM) into an established IV sedation regimen compared with control IV sedation without the DXM infusion.
MATERIALS AND METHODS


We designed a prospective, controlled trial in which American Society of Anesthesiologists Class 1 and 2 patients requiring both maxillary and mandibular dentoalveolar surgery would undergo 2 sedation appointments: 1 arch treated with surgery with control sedation (DXM-) using midazolam, fentanyl, and propofol as needed, and a second surgery on the opposite arch using the experimental sedation regimen (DXM+) of midazolam, fentanyl, and propofol, as needed, and a DXM infusion at 4 μg/kg/hr. The surgeon was the same for every appointment, and the patients were kept unaware regarding which sedation had included the experimental regimen. Whether the experimental sedation was used at the first or second surgery was randomized. The primary measured outcomes were efficiency in terms of anesthesia time for each sedation, the physiologic response in terms of vital signs, and the subjective patient experience.
RESULTS


A total of 12 patients completed the trial. With DXM-, the patients had significantly shorter total (∼15 minutes) and adjusted anesthesia (∼10 minutes) times. With DXM+, the patients had significantly lower average systolic blood pressure (SBP), SBP low values, diastolic blood pressure (DBP) low values, average heart rate (HR), and HR low values. None of the other continuous patient outcomes differed significantly between the 2 groups. Of the 12 patients, 10 (83.3%) reported that they preferred the experimental sedation experience with DXM (95% confidence interval, 0.52 to 0.98).
CONCLUSIONS


Using a DXM infusion with outpatient dentoalveolar surgery allowed for acceptable levels of sedation, greater patient satisfaction, and longer anesthesia and appointment times and often resulted in lower BP and heart rate.",2020,"With DXM-, the patients had significantly shorter total (∼15 minutes) and adjusted anesthesia (∼10 minutes) times.",['12 patients completed the trial'],"['midazolam, fentanyl, and propofol', 'surgery with control sedation (DXM-) using midazolam, fentanyl, and propofol', 'dexmedetomidine (DXM', 'Dexmedetomidine']","['average systolic blood pressure (SBP), SBP low values, diastolic blood pressure (DBP) low values, average heart rate (HR), and HR low values', 'lower BP and heart rate', 'efficiency in terms of anesthesia time for each sedation, the physiologic response in terms of vital signs, and the subjective patient experience']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0453159,"With DXM-, the patients had significantly shorter total (∼15 minutes) and adjusted anesthesia (∼10 minutes) times.","[{'ForeName': 'D Craig', 'Initials': 'DC', 'LastName': 'Taylor', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Augusta University, Augusta, GA. Electronic address: CraigTaylorDMD@gmail.com.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Ferguson', 'Affiliation': 'Vice Chairman and Associate Professor, Department of Oral and Maxillofacial Surgery, Augusta University, Augusta, GA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stevens', 'Affiliation': 'Chairman and Professor, Department of Oral and Maxillofacial Surgery, Augusta University, Augusta, GA.'}, {'ForeName': 'Solon', 'Initials': 'S', 'LastName': 'Kao', 'Affiliation': 'Vice Chairman and Associate Professor, Department of Oral Surgery and Hospital Dentistry, University of Missouri-Kansas City, Kansas City, MO.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Yang', 'Affiliation': 'Associate Professor, Department of Occupational Therapy, School of Health Professions, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Looney', 'Affiliation': 'Professor, Department of Biostatistics and Data Science, Augusta University, Augusta, GA.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.08.016']
3410,32006009,Increased Iron Status during a Feeding Trial of Iron-Biofortified Beans Increases Physical Work Efficiency in Rwandan Women.,"BACKGROUND


Iron-biofortified staple foods can improve iron status and resolve iron deficiency. However, whether improved iron status from iron biofortification can improve physical performance remains unclear.
OBJECTIVE


This study aimed to examine whether changes in iron status from an iron-biofortified bean intervention affect work efficiency.
METHODS


A total of 125 iron-depleted (ferritin <20 μg/L) female Rwandan university students (18-26 y) were selected from a larger sample randomly assigned to consume iron-biofortified beans (Fe-Bean; 86.1 mg Fe/kg) or conventional beans (control: 50.6 mg Fe/kg) twice daily for 18 wk (average of 314 g beans consumed/d). Blood biomarkers of iron status (primary outcome) and physical work efficiency (secondary outcome) were measured before and after the intervention. Work performed was assessed during 5-min steady-state periods at 0-, 25-, and 40-W workloads using a mechanically braked cycle ergometer. Work efficiency was calculated at 25 W and 40 W as the work accomplished divided by the energy expended at that workload above that expended at 0 W. General linear models were used to evaluate the relation between changes in iron status biomarkers and work efficiency.
RESULTS


The Fe-Bean intervention had significant positive effects on hemoglobin, serum ferritin, and body iron stores but did not affect work efficiency. However, 18-wk change in hemoglobin was positively related to work efficiency at 40 W in the full sample (n = 119; estimate: 0.24 g/L; 95% CI: 0.01, 0.48 g/L; P = 0.044) and among women who were anemic (hemoglobin <120 g/L) at baseline (n = 43; estimate: 0.64 g/L; 95% CI: 0.05, 1.23 g/L; P = 0.036). Among women who were nonanemic at baseline, change in serum ferritin was positively related to change in work efficiency at 40 W (n = 60; estimate: 0.50 μg/L; 95% CI: 0.06, 0.95 μg/L; P = 0.027).
CONCLUSIONS


Increasing iron status during an iron-biofortified bean feeding trial improves work efficiency in iron-depleted, sedentary women. This trial was registered at clinicaltrials.gov as NCT01594359.",2020,"The Fe-Bean intervention had significant positive effects on hemoglobin, serum ferritin, and body iron stores but did not affect work efficiency.","['A total of 125 iron-depleted (ferritin <20\xa0μg/L) female Rwandan university students (18-26 y', 'sedentary women', 'Rwandan Women']","['Iron-Biofortified Beans', 'consume iron-biofortified beans (Fe-Bean; 86.1\xa0mg Fe/kg) or conventional beans']","['serum ferritin', 'Blood biomarkers of iron status (primary outcome) and physical work efficiency (secondary outcome', 'Work efficiency', 'hemoglobin', 'hemoglobin, serum ferritin, and body iron stores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0004896', 'cui_str': 'Bean (substance)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}]",,0.196472,"The Fe-Bean intervention had significant positive effects on hemoglobin, serum ferritin, and body iron stores but did not affect work efficiency.","[{'ForeName': 'Sarah V', 'Initials': 'SV', 'LastName': 'Luna', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Pompano', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mercy', 'Initials': 'M', 'LastName': ""Lung'aho"", 'Affiliation': 'Centro Internacional de Agricultura Tropical-Uganda, Kawanda, Uganda.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Gahutu', 'Affiliation': 'School of Medicine and Pharmacy, College of Medicine and Health Sciences, University of Rwanda, Huye, Rwanda.'}, {'ForeName': 'Jere D', 'Initials': 'JD', 'LastName': 'Haas', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa016']
3411,30385250,The Impact of a Healthy Weight Intervention Embedded in a Home-Visiting Program on Children's Weight and Mothers' Feeding Practices.,"OBJECTIVE


To examine whether a healthy weight intervention embedded in the Parents as Teachers (PAT) home visiting program, which was previously found to improve mothers' body mass index (BMI) and obesity-related behaviors, changed the BMI of preschool children or maternal feeding practices.
METHODS


This stratified randomized trial included preschool-aged children at risk for overweight whose mothers were overweight or had obesity (n = 179). The Healthy Eating and Active Living Taught at Home (HEALTH) intervention was based on the Diabetes Prevention Program. Differences were examined using repeated-measures mixed-ANOVA models.
RESULTS


Compared with PAT usual care, the HEALTH intervention had no effect on children's BMI or maternal feeding practices. However, combined analyses showed that children's BMI percentile decreased (P  = .007), BMI z-scores were maintained (P  = .19), and 3 of 8 feeding practices improved over time (P < .05).
CONCLUSIONS AND IMPLICATIONS


Additional research is needed to assess the effectiveness of PAT to prevent preschool-age obesity using rigorous designs (eg, group-randomized trials) and to identify its active components. HEALTH is ready to be scaled up to prevent maternal weight gain through embedding within the national PAT program.",2019,"However, combined analyses showed that children's BMI percentile decreased (P  = .007), BMI z-scores were maintained (","[""Children's Weight and Mothers' Feeding Practices"", 'preschool children or maternal feeding practices', 'preschool-aged children at risk for overweight whose mothers were overweight or had obesity (n\u202f=\u202f179']","['PAT', 'Healthy Weight Intervention Embedded in a Home-Visiting Program', 'healthy weight intervention embedded in the Parents as Teachers (PAT) home visiting program', 'Healthy Eating and Active Living Taught at Home (HEALTH) intervention']","['BMI z-scores', ""children's BMI or maternal feeding practices"", ""children's BMI percentile"", ""mothers' body mass index (BMI) and obesity-related behaviors""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}]","[{'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.02163,"However, combined analyses showed that children's BMI percentile decreased (P  = .007), BMI z-scores were maintained (","[{'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Morshed', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, MO. Electronic address: a.b.morshed@wustl.edu.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Tabak', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, MO.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Schwarz', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, MO.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Brown School, Washington University in St Louis, St Louis, MO; Department of Medicine, Washington University School of Medicine, Washington University in St Louis, St Louis, MO.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.09.001']
3412,30126714,Audio-Recorded Discharge Instructions for Limited English Proficient Parents: A Pilot Study.,"BACKGROUND


Parents with limited English proficiency (LEP) demonstrate lower comprehension of discharge instructions. A study was conducted to (1) determine the feasibility of providing a greeting card with language-specific, audio-recorded discharge instructions to LEP parents; (2) describe use of and satisfaction with the cards; and (3) evaluate card effect on instruction comfort with home care and comprehension.
METHODS


LEP parents of children undergoing day surgery from April to September 2016 were eligible. Participants were randomized to usual discharge instructions, or usual instructions plus a three-minute card with language-specific audio instructions that could be replayed repeatedly. Parents were surveyed by telephone two to seven days postdischarge to assess card use and satisfaction, comfort with home care, and discharge instruction recall (medications, home care, follow-up, and return precautions). Parent-reported instructions were compared to instructions in the medical record; concordance was determined by two blinded reviewers. Due to difficulty achieving recruitment goals, analysis focused on feasibility and acceptability.
RESULTS


Of  83 parents enrolled, 66 (79.5%) completed the follow-up survey. Most had not completed high school (61.0%) and spoke Spanish (89.2%). Parents reported high satisfaction with the card (4.5/5 for ease of use, helpfulness, and understandability). Ninety-four percent shared the card with others, and 45.2% reported listening > 5 times. Besides reviewing the care instructions generally, parents reported using the card to review medications and engage others in the child's care.
CONCLUSION


Providing language-concordant, audio-recorded discharge instructions was feasible, and parents reported high satisfaction with and frequent use of the cards with multiple caregivers.",2019,"Participants were randomized to usual discharge instructions, or usual instructions plus a three-minute card with language-specific audio instructions that could be replayed repeatedly.","['Parents with limited English proficiency (LEP', 'Of\u2009 83 parents enrolled, 66 (79.5%) completed the follow-up survey', 'LEP parents of children undergoing day surgery from April to September 2016 were eligible']","['greeting card with language-specific, audio-recorded discharge instructions to LEP parents', 'Audio-Recorded Discharge Instructions', 'usual discharge instructions, or usual instructions plus a three-minute card with language-specific audio instructions that could be replayed repeatedly']",[],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4554227', 'cui_str': 'Repeatedly - dosing instruction fragment'}]",[],83.0,0.0465293,"Participants were randomized to usual discharge instructions, or usual instructions plus a three-minute card with language-specific audio instructions that could be replayed repeatedly.","[{'ForeName': 'K Casey', 'Initials': 'KC', 'LastName': 'Lion', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kieran', 'Affiliation': ''}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': ''}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Hencz', 'Affiliation': ''}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Ebel', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Adem', 'Affiliation': ''}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Forbes', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Kraus', 'Affiliation': ''}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Gutman', 'Affiliation': ''}, {'ForeName': 'Ivor', 'Initials': 'I', 'LastName': 'Horn', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2018.06.001']
3413,32001798,"Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.","In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.",2020,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","['Patients (N\u2009=\u2009569) with ≥1 prior line received', 'relapsed/refractory multiple myeloma']","['Rd (lenalidomide', 'POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd', 'Daratumumab plus lenalidomide and dexamethasone', 'dexamethasone, 40\u2009mg, weekly)\u2009±\u2009daratumumab']","['Median time to next therapy', 'D-Rd prolonged progression-free survival (PFS', 'risk of disease progression or death', 'MRD negativity', 'Minimal residual disease (MRD', 'overall response rate (ORR', 'ORR', 'Median PFS on subsequent line of therapy (PFS2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",569.0,0.152505,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","[{'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada. nbahlis@ucalgary.ca.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okonkwo', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Leukemia,['10.1038/s41375-020-0711-6']
3414,31991017,Novel modified Peyton's approach for knowledge retention on newborn life support training in medical students.,"AIM


We sought to improve retention of neonatal resuscitation skills by modifying step 3 through additional functional verbalisation in Peyton's four-step approach (P4S).
METHODS


Newborn life support (NLS) training was performed in a simulation-based setting. In contrast to the traditional approach, students taught with the modified approach were requested to explain every step of their performance in Peyton's step 3. A total of 123 students were allocated into both experimental groups. Students were then assessed by megacode on day four (initial assessment) and 6 months (follow-up assessment).
RESULTS


Both groups showed similar scorings in the initial, follow-up assessment and in mean change. On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group. All showed a significant loss of performance irrespective of modification in step 3 in the follow-up assessment. Only time until start with post-resuscitation care shows a significant group difference in mean change between initial and follow-up with increasing time in the control and decreasing time span in intervention group.
CONCLUSION


Both methods showed equal levels of knowledge acquisition and long-term decline in NLS performances. Verbalisation in step 3 influenced speed of applied NLS performance.",2020,"On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group.","['123 Students', 'medical students']","['Novel modified Peyton approach', 'Newborn life support (NLS) training']","['speed of applied NLS performance', 'equal levels of knowledge acquisition and long-term decline in NLS performances', 'time span']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",123.0,0.013784,"On initial megacode, time to start with initial inflation and post-resuscitation care was significantly faster in the control group.","[{'ForeName': 'Nasenien', 'Initials': 'N', 'LastName': 'Nourkami-Tutdibi', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Hilleke', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wagenpfeil', 'Affiliation': 'Saarland University Medical Center, Institute of Medical Biometry, Epidemiology and Medical Informatics, Homburg, Germany.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Tutdibi', 'Affiliation': 'Saarland University Medical Center, Hospital for General Pediatrics and Neonatlogy, Homburg, Germany.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15198']
3415,31987113,"A combined effect of Cavacurcumin, Eicosapentaenoic acid (Omega-3s), Astaxanthin and Gamma -linoleic acid (Omega-6) (CEAG) in healthy volunteers- a randomized, double-blind, placebo-controlled study.","BACKGROUND


Inflammation plays a key role and is one of the early steps in the pathogenesis of endothelial function, thereby increasing the risk of hypertension (HTN), coronary artery disease (CAD), stroke and several other risk factors of cardiovascular disease (CVD). We assessed the efficacy for improving cardiovascular health (blood pressure, inflammation and endothelial reactivity) over a 4-week intervention period in healthy individuals.
METHODS


We performed a randomized, double-blinded, placebo-controlled, randomized clinical trial to investigate Curcumin, Eicosapentaenoic acid (EPA), Astaxanthin and Gamma -linoleic acid (GLA) (CEAG) supplements with 80 individuals (30 men and 50 women). The mean age of participants was 48.8 ± 16.0 years. Participants were enrolled and randomized to active or placebo and followed for 4 weeks. Paired and Independent T-tests were used to analyze the mean differences between and within groups.
RESULTS


The primary endpoints of the study were the effect on inflammatory markers (IL-6, CRP), endothelial function and blood pressure at 4 weeks. There was a significant reduction in mean SBP at 4 weeks in the CEAG group compared to placebo [mean ± SD 4.7 ± 6.8 (p = 0.002)]. Relative to placebo, active group showed a significant decrease in High sensitivity C Reactive Protein (hsCRP) (-0.49 ± 1.9 vs + 0.51 ± 2.5, p = 0.059) and blunted increase in IL-6 (+0.2 vs + 0.4 in placebo, p = 0.60).
CONCLUSION


Inflammatory markers were reduced or blunted by CEAG, with a robust increase in both EPA levels and the fatty acid index. Furthermore, systolic BP was reduced over 4 weeks with concurrent improvement in endothelial function. CLINICALTRIALS.
GOV ID


NCT03906825.",2020,"Relative to placebo, active group showed a significant decrease in High sensitivity C Reactive Protein (hsCRP) (-0.49 ± ","['healthy individuals', '80 individuals (30 men and 50 women', 'The mean age of participants was 48.8\xa0±\xa016.0 years', 'healthy volunteers']","['Curcumin, Eicosapentaenoic acid (EPA), Astaxanthin and Gamma -linoleic acid (GLA) (CEAG) supplements', 'placebo', 'CEAG', 'Cavacurcumin, Eicosapentaenoic acid (Omega-3s), Astaxanthin and Gamma -linoleic', 'acid (Omega-6']","['High sensitivity C Reactive Protein (hsCRP) (-0.49\xa0±', 'inflammatory markers (IL-6, CRP), endothelial function and blood pressure', 'cardiovascular health (blood pressure, inflammation and endothelial reactivity', 'systolic BP', 'mean SBP', 'EPA levels and the fatty acid index', 'IL-6', 'endothelial function']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0052565', 'cui_str': 'astaxanthin'}, {'cui': 'C0937623', 'cui_str': 'GAMMA LINOLEIC ACID'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.700771,"Relative to placebo, active group showed a significant decrease in High sensitivity C Reactive Protein (hsCRP) (-0.49 ± ","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Birudaraju', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Cherukuri', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'Bhanu T', 'Initials': 'BT', 'LastName': 'Chaganti', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Hamal', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Flores', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Roy', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Department of Cardiology, Torrance, CA, USA. Electronic address: mbudoff@labiomed.org.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.09.011']
3416,31795748,Role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema: a randomized controlled trial.,"OBJECTIVE


To evaluate the role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema.
DESIGN


Randomized controlled trial.
SETTING


Physical medicine and rehabilitation clinic at a university hospital.
SUBJECTS


Seventy-six patients with lymphoedema.
INTERVENTIONS


Patients were allocated into Group 1 (complex decongestive treatment,  n  = 38) and Group 2 (complex decongestive treatment + intermittent pneumatic compression,  n  = 38). The complex decongestive treatment involved skin care, manual lymphatic drainage, compression bandaging, and exercise for 20 sessions. Group 2 additionally received intermittent pneumatic compression.
MAIN MEASURES


Quantitative outcomes consisted of volumetric measures prior to and after the treatment. Clinical assessments included severity of pain, heaviness and tightness, disability, grip strength, and depression.
RESULTS


Lymphoedema was similar at baseline, but treatments significantly reduced the excess volume (from 373 mL to 203 mL in Group 1 and 379.5 mL to 189.5 mL in Group 2). Percentage excess volumes (PEVs) decreased in both groups. The percentage reduction of excess volume was better in Group 2 than Group 1, but the intergroup difference was not significant. The clinical scores reflected improvements, but the heaviness and tightness read significantly lower in Group 2 than Group 1.
CONCLUSION


Intermittent pneumatic compression seems to add no benefit when combined with complex decongestive treatment of lymphoedema, but, may be functional in reducing the sensations of heaviness and tightness for the patients with pitting oedema.",2020,"The percentage reduction of excess volume was better in Group 2 than Group 1, but the intergroup difference was not significant.","['patients with pitting oedema', 'breast cancer-related lymphoedema', 'Physical medicine and rehabilitation clinic at a university hospital', 'Seventy-six patients with lymphoedema']","['intermittent pneumatic compression', 'Patients were allocated into Group 1 (complex decongestive treatment,  n \u2009=\u200938) and Group 2 (complex decongestive treatment\u2009+\u2009intermittent pneumatic compression,  n \u2009=\u200938']","['percentage reduction of excess volume', 'severity of pain, heaviness and tightness, disability, grip strength, and depression', 'Percentage excess volumes (PEVs', 'heaviness and tightness read']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439816', 'cui_str': 'Tight'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",76.0,0.0334386,"The percentage reduction of excess volume was better in Group 2 than Group 1, but the intergroup difference was not significant.","[{'ForeName': 'Engin', 'Initials': 'E', 'LastName': 'Tastaban', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Soyder', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Aydin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Sendur', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Turan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Mevlut', 'Initials': 'M', 'LastName': 'Ture', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Bilgen', 'Affiliation': 'Department of Biophysics, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.'}]",Clinical rehabilitation,['10.1177/0269215519888792']
3417,31987122,Fish oil supplementation in cancer patients. Capsules or nutritional drink supplements? A controlled study of compliance.,"BACKGROUND & AIMS


Fish-oil, rich in Omega-3 long chain polyunsaturated fatty acids (n-3 LC PUFAs), may in high doses inhibit the development or progression of cancer cachexia. However, poor compliance to oral nutritional supplements is a well-known problem. We aimed to investigate acceptability and compliance to a nutritional drink with fish-oil compared to an equivalent dose of fish-oil administered as capsules in patients receiving chemotherapy for GI tract cancers. Moreover, we aimed to investigate, if there was a difference between a nutritional drink or capsules with respect to nutritional status and side effects. Finally, we aimed to examine, if n-3 LC PUFAs affect leukocyte and platelet counts, and markers of dose-limiting toxicities of chemotherapy.
METHODS


We consecutively included 41 patients with advanced cancer in the controlled study. Patients were allocated (not randomized) to ingest either 10 capsules/day for four weeks or 400 mL/day of a nutritional drink with same dose of n-3 LC PUFA dose. Compliance was assessed by daily self-registration and n-3 LC PUFAs in whole blood. Side effects were assessed by 10 cm visual analog scales.
RESULTS


Compliance and daily consumption of n-3 LC PUFAs were 96.4% (94.1-99.3) and 4.8 (4.7-4.9) g/day in the capsule group and 80.8 (55.4-93.6) % and 4.0 (2.8-4.7) g/day in the group, respectively (p ≤ 0.02). We found no differences between the groups with respect to changes in whole blood n-3 LC PUFAs, weight, nutritional status, acceptability or side effects. However, in the capsule group the whole blood n-3 LC PUFAs correlated negatively with the increase in nausea (r s  = -0.39, p = 0.05), but not in the nutritional drink group. Nausea, reduced appetite and loose stools were of greatest importance for the deviations from recommended doses. The number of capsules had a negative impact on acceptability and compliance, whereas this was mainly related to taste and texture in the nutritional drink group. No changes in median thrombocyte or leukocyte blood counts were observed.
CONCLUSIONS


Fish oil in capsules appeared to result in better compliance compared to a nutritional drink with an equivalent dose of n-3 LC PUFAs. However, capsules and the drink did not differ with respect to the effect on nutritional status or side effects. TRIAL REGISTRATION CLINICALTRIALS.
GOV IDENTIFIER


NCT03751384.",2020,"We found no differences between the groups with respect to changes in whole blood n-3 LC PUFAs, weight, nutritional status, acceptability or side effects.","['patients receiving chemotherapy for GI tract cancers', '41 patients with advanced cancer in the controlled study', 'cancer patients']","['Fish oil supplementation', 'nutritional drink with fish-oil', 'nutritional drink with same dose of n-3 LC PUFA dose', 'n-3 LC PUFAs', 'Fish oil']","['nutritional status or side effects', 'median thrombocyte or leukocyte blood counts', 'whole blood n-3 LC PUFAs', 'Compliance and daily consumption of n-3 LC PUFAs', 'nausea', 'Side effects', 'Nausea, reduced appetite and loose stools', 'whole blood n-3 LC PUFAs, weight, nutritional status, acceptability or side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",41.0,0.0607654,"We found no differences between the groups with respect to changes in whole blood n-3 LC PUFAs, weight, nutritional status, acceptability or side effects.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Schmidt', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Grith', 'Initials': 'G', 'LastName': 'Møller', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958 Frederiksberg C, Denmark. Electronic address: grith_moller@hotmail.com.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Bæksgaard', 'Affiliation': 'Department of Oncology, Rigshospitalet, DK 2100 Copenhagen Ø, Denmark.'}, {'ForeName': 'Kell', 'Initials': 'K', 'LastName': 'Østerlind', 'Affiliation': 'Department of Oncology, Rigshospitalet, DK 2100 Copenhagen Ø, Denmark.'}, {'ForeName': 'Ken D', 'Initials': 'KD', 'LastName': 'Stark', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Lauritzen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Jens Rikardt', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958 Frederiksberg C, Denmark.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.12.004']
3418,31987127,Safety and efficacy of salt substitution with a low sodium-potassium enriched dietary salt in patients with heart failure with reduced ejection fraction: A pilot study.,"BACKGROUND AND AIMS


Increased sodium intake is associated with increased risk of decompensation in patients with heart failure. This non-randomized, open-label, controlled study aimed to examine the feasibility, preliminary safety and efficacy of a low sodium-potassium enriched salt substitute compared to regular table salt in patients with heart failure with reduced ejection fraction (HFREF).
METHODS


Fifty patients (68% male, NYHA I/II/III 6%/68%/26%, mean age 70 ± 9 years, LVEF 31 ± 5%, median BNP 112 pg/ml) were included. Of these, 30 patients received the salt substitute (maximum consumption of 2 g daily), who were prospectively compared to a control group of 20 age/sex/NYHA class-matched HFREF patients who consumed regular salt (maximum consumption of 2 g daily). Consumption of regular salt was prohibited in the salt substitution group. All patients were followed for 12 weeks.
RESULTS


Patient groups did not differ by sex, age, LVEF, NYHA class, 6MWD, and BNP at baseline. In primary safety analysis, no significant differences were detected between groups regarding SBP (p = 0.052), DBP (p = 0.159), HR (p = 0.246), serum potassium (p = 0.579), serum sodium (p = 0.125), and eGFR (p = 0.710) throughout the 12 weeks. Secondary efficacy analysis revealed a statistically significant difference in 6MWD at 12 weeks between the salt substitute and regular salt groups after adjustment for baseline 6MWD (mean difference±SEM, 4.7 ± 2.1 m, F = 4.92, p = 0.031).
CONCLUSIONS


In this pilot study, a low sodium-potassium enriched salt substitute was found to be safe compared to regular salt in HFREF patients, while it resulted in a small albeit significant improvement in exercise capacity, possibly justifying further investigation with randomized clinical studies.",2020,"Secondary efficacy analysis revealed a statistically significant difference in 6MWD at 12 weeks between the salt substitute and regular salt groups after adjustment for baseline 6MWD (mean difference±SEM, 4.7 ± 2.1 m, F = 4.92, p = 0.031).
","['patients with heart failure with reduced ejection fraction (HFREF', 'Fifty patients (68% male, NYHA', '30 patients received the', 'patients with heart failure with reduced ejection fraction', 'patients with heart failure', 'HFREF patients']","['low sodium-potassium enriched salt substitute', 'salt substitution with a low sodium-potassium enriched dietary salt', 'salt substitute (maximum consumption of 2\xa0g daily', 'control group of 20 age/sex/NYHA class-matched HFREF patients who consumed regular salt (maximum consumption of 2\xa0g daily']","['6MWD', 'DBP', 'serum potassium', 'SBP', 'serum sodium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}]",,0.0452279,"Secondary efficacy analysis revealed a statistically significant difference in 6MWD at 12 weeks between the salt substitute and regular salt groups after adjustment for baseline 6MWD (mean difference±SEM, 4.7 ± 2.1 m, F = 4.92, p = 0.031).
","[{'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Bistola', 'Affiliation': 'Heart Failure Unit, Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: vasobistola@yahoo.com.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Arfaras-Melainis', 'Affiliation': 'Heart Failure Unit, Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Efstratios', 'Initials': 'E', 'LastName': 'Trogkanis', 'Affiliation': 'Cardiology Clinic, General Hospital Department of Cardiology, Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Bakosis', 'Affiliation': 'Heart Failure Unit, Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Eftihia', 'Initials': 'E', 'LastName': 'Polyzogopoulou', 'Affiliation': 'Emergency Medicine Department, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis-Nektarios', 'Initials': 'IN', 'LastName': 'Karavidas', 'Affiliation': 'Cardiology Clinic, General Hospital Department of Cardiology, Gennimatas General Hospital, Athens, Greece.'}, {'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': 'Heart Failure Unit, Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': 'Heart Failure Unit, Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Karavidas', 'Affiliation': 'Cardiology Clinic, General Hospital Department of Cardiology, Gennimatas General Hospital, Athens, Greece.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.11.004']
3419,31987116,"Effect of a low energy diet, containing a high protein, probiotic condensed yogurt, on biochemical and anthropometric measurements among women with overweight/obesity: A randomised controlled trial.","BACKGROUND & AIMS


The aim of this study was to determine the effect of low energy diet containing condensed processed yogurt (Kashk), as a high protein, calcium and probiotic enriched product, on glycemic control, lipid profile, anthropometric measurements and blood pressure among women with overweight/obesity.
METHODS


70 women with overweight/obesity were randomly assigned to receive either a low energy diet contained 50 g of Kashk (intervention group) or a low energy diet without Kashk (control group) for 8 weeks. Anthropometric, blood pressure and biochemical measurements were obtained before and after the intervention.
RESULTS


Between-group comparisons showed that the intervention group significantly decreased triglycerides (P = 0.013) and low density lipoprotein cholesterol (P = 0.049) levels relative to the control group. Significantly greater reductions in body mass index (P = 0.018), fat percent (P = 0.037) and waist circumference (P = 0.047) were observed in the intervention group compared to control. Within-group comparisons revealed significant reductions in systolic blood pressure (P = 0.035) and weight (P = 0.005) in the intervention group.
CONCLUSIONS


Long-term consumption of Kashk, as a high protein and calcium product enriched with probiotic that is accompanied by a low energy diet, might have beneficial effects on anthropometric and biochemical indices, though more cross-over and parallel blinded trials with placebo groups are needed to confirm these results. (The clinical trial registration number is IRCT2013042913163N1).",2020,"Significantly greater reductions in body mass index (P = 0.018), fat percent (P = 0.037) and waist circumference (P = 0.047) were observed in the intervention group compared to control.","['women with overweight/obesity', '70 women with overweight/obesity']","['low energy diet containing condensed processed yogurt (Kashk', 'low energy diet, containing a high protein, probiotic condensed yogurt', 'placebo', 'low energy diet contained 50\xa0g of Kashk (intervention group) or a low energy diet without Kashk (control group']","['systolic blood pressure', 'body mass index', 'triglycerides', 'glycemic control, lipid profile, anthropometric measurements and blood pressure', 'waist circumference', 'low density lipoprotein cholesterol', 'Anthropometric, blood pressure and biochemical measurements', 'weight']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3654008', 'cui_str': 'Low-energy diets'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",70.0,0.184165,"Significantly greater reductions in body mass index (P = 0.018), fat percent (P = 0.037) and waist circumference (P = 0.047) were observed in the intervention group compared to control.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Safi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nadjarzadeh', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: azadehnajarzadeh@gmail.com.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2019.10.001']
3420,31058772,"Enhanced Protein Diet for Preterm Infants: A Prospective, Randomized, Double-blind, Controlled Trial.","OBJECTIVE


To evaluate dietary protein's effect on fat accretion and weight gain in hospitalized preterm infants.
METHODS


Prospective, randomized, double-blind, controlled trial of 36 infants born at <32 weeks, hospitalized in a tertiary neonatal intensive care unit. After achieving full enteral volume, infants were randomized to either an enhanced protein diet (EPD) (protein-energy ratio [PER] 4 g/100 calories) or a standard protein diet (SPD) (PER 3 g/100 calories). Macronutrients were calculated using published values for formula, donor milk bank analysis, or weekly analysis of a 24-hour pooled maternal milk sample. Human milk fortifier and/or liquid protein were used to achieve the target PER until discharge or a maximum of 4 weeks. Body composition was measured weekly using air displacement plethysmography. The principal outcomes, rates of weight gain and fat accretion, were compared between groups in linear mixed models.
RESULTS


Thirty-three infants received approximately 17 days of the study diet. Relative weight gain was 21.6 g · kg · day (95% confidence interval [CI] 19.5-23.8) for the EPD group (n = 16) versus 19.1 g · kg · day (95% CI 17.0-21.2) for the SPD group (n = 17), P = 0.095. Baseline percent fat mass (FM) in the EPD group was 5.15% (95% CI 3.58%-6.72%) compared with 7.29% (95% CI 5.73%-8.84%) in the SPD group, P = 0.0517. Percent FM increased 0.398%/day (95% CI 0.308-0.488) for the EPD group versus 0.284%/day (95% CI 0.190-0.379) for the SPD group (P = 0.0878).
CONCLUSIONS


Preterm infants with a lower baseline FM percentage who received an EPD demonstrated a more pronounced catch-up percentage of fat accretion.",2019,"Percent FM increased 0.398%/day (95% CI 0.308-0.488) for the EPD group versus 0.284%/day (95% CI 0.190-0.379) for the SPD group (P = 0.0878).
","['36 infants born at <32 weeks, hospitalized in a tertiary NICU', 'Human milk fortifier', 'Preterm Infants', 'hospitalized preterm infants', 'Preterm infants with a lower baseline FM percentage who received an']","['Enhanced Protein Diet', 'EPD', 'enhanced protein diet (EPD) (protein-energy ratio [PER] 4\u200ag/100 calories) or a standard protein diet (SPD) (PER 3\u200ag/100 calories']","['Body composition', 'fat accretion and weight gain', 'rates of weight gain and fat accretion', 'Relative weight gain', 'Baseline percent fat mass (FM']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C3853188', 'cui_str': 'Human milk fortifier'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0452269', 'cui_str': 'Protein diet (finding)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",36.0,0.569534,"Percent FM increased 0.398%/day (95% CI 0.308-0.488) for the EPD group versus 0.284%/day (95% CI 0.190-0.379) for the SPD group (P = 0.0878).
","[{'ForeName': 'Courtney B', 'Initials': 'CB', 'LastName': 'Atchley', 'Affiliation': 'Neonatal-Perinatal Medicine, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cloud', 'Affiliation': ""Food and Nutrition Services, University of Oklahoma Children's Hospital, Oklahoma City.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Blunt', 'Affiliation': 'Neonatal-Perinatal Medicine, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Kelli J', 'Initials': 'KJ', 'LastName': 'Satnes', 'Affiliation': 'Neonatal-Perinatal Medicine, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal-Perinatal Medicine, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Ernst', 'Affiliation': 'Neonatal-Perinatal Medicine, University of Oklahoma Health Sciences Center.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002376']
3421,31588026,A Randomized Trial of Alerting to Low Glycated Hemoglobin Level in Older Adults: Results of the Low Indexes of Metabolism Intervention Trial B (LIMIT-B).,"OBJECTIVES


The benefit of alerting clinical staff to low plasma glycated hemoglobin (HbA1c) in patients aged 75 years and older who receive antidiabetic drugs remains uncertain.
DESIGN, SETTING, AND PARTICIPANTS


In a randomized controlled trial, 1684 patients with HbA1c ≤ 6.5% who received antidiabetic drugs were assigned to have an e-mail alert sent to their physician, and 1643 were assigned to have no such alert (control group). The primary outcome of the trial was annual death. Secondary outcomes included antidiabetic drug dose reduction and HbA1c change.
RESULTS


In the first quarter, antidiabetic drug-defined daily doses were reduced on average by 10.4 ± 35.8 (16% ± 55%) in the intervention group and by 6.4 ± 36.1 (10% ± 56%) in the control group (difference -4.1 ± 1.2, 95% confidence interval [CI] -6.5 to -1.6; P = .001). Measured HbA1c levels were raised by a mean (± standard deviation) of 0.28 ± 0.77 in the intervention group and by 0.18 ± 0.57 in the control group (difference 0.10 ± 0.02, 95% CI -0.15 to -0.059, P < .001). One year after the alerts, 121 patients (7.2%) died in the intervention group and 107 patients (6.5%) died in the control group (relative risk 1.1, 95% CI 0.86-1.42; P = .44).
CONCLUSIONS AND IMPLICATIONS


In this trial, alerting clinical staff to low HbA1c in patients aged 75 years and older treated with antidiabetic medicines was associated with mildly reduced antidiabetic doses and increased HbA1c but was not associated with a significant difference in survival rate compared with usual clinical care.",2020,"relative risk 1.1, 95% CI 0.86-1.42; P = .44).
","['Older Adults', 'patients aged 75\xa0years and older treated with', '1684 patients with HbA1c\xa0≤\xa06.5% who received antidiabetic drugs were assigned to have an e-mail alert sent to their physician, and 1643 were assigned to have no such alert (control group', 'patients aged 75\xa0years and older who receive antidiabetic drugs remains uncertain']",['antidiabetic medicines'],"['survival rate', 'Measured HbA1c levels', 'annual death', 'antidiabetic drug dose reduction and HbA1c change']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]","[{'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",1684.0,0.25575,"relative risk 1.1, 95% CI 0.86-1.42; P = .44).
","[{'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Tsabar', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel; The Azrieli Faculty of Medicine in Galilee, Bar-Ilan University, Safed, Israel; International Group for Reducing Inappropriate Medication Use & Polypharmacy (IGRIMUP), Bat Yam, Israel. Electronic address: tsabar.nir@gmail.com.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Press', 'Affiliation': 'Department of Family Medicine, Sial Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Unit for Community Geriatrics, Division of Health in the Community, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Geriatrics, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Rotman', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel.'}, {'ForeName': 'Bracha', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Grossman', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel; The Azrieli Faculty of Medicine in Galilee, Bar-Ilan University, Safed, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Vainshtein-Tal', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Eilat-Tsanani', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel; The Azrieli Faculty of Medicine in Galilee, Bar-Ilan University, Safed, Israel.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.08.004']
3422,31706917,Effects of a Multicomponent Frailty Prevention Program in Prefrail Community-Dwelling Older Persons: A Randomized Controlled Trial.,"OBJECTIVE


To examine the effects of a multicomponent frailty prevention program in community-dwelling older persons with prefrailty.
DESIGN


A randomized controlled trial.
SETTING


A community elderly center in Hong Kong.
PARTICIPANTS


Persons aged ≥50 years who scored 1-2 on a simple frailty questionnaire (FRAIL) METHODS: Participants (n = 127) were randomly assigned to a 12-week multicomponent frailty prevention program (exercise, cognitive training, board game activities) or to a wait-list control group. The primary outcomes were FRAIL scores, frailty status, and a combined frailty measure including subjective (FRAIL total score) and objective (grip strength, muscle endurance, balance, gait speed) measures. The secondary outcomes were verbal fluency assessed by dual-task gait speed, attention and memory assessed by digit span task, executive function assessed by the Frontal Assessment Battery, self-rated health, and life satisfaction. Assessments were conducted at baseline and at week 12.
RESULTS


The mean age of the participants was 62.2 years, and 88.2% were women. At week 12, the FRAIL score had decreased in the intervention group (-1.3, P < .001) but had increased in the control group (0.3, P < .01) (between-group differences P < .001). In addition, 83.3% and 1.6% of the intervention and control groups, respectively, had reversed from prefrailty to robust phenotype (between-group differences P < .001). Participants in the intervention group also had a greater reduction in the combined frailty score and greater improvements in muscle endurance, balance, verbal fluency, attention and memory, executive function, and self-rated health than those in the control group (all P < .05). There were no significant differences between the groups with respect to grip strength, gait speed, and life satisfaction.
CONCLUSIONS AND IMPLICATIONS


The multicomponent frailty prevention program reduced frailty and improved physical and cognitive functions, and self-rated health in community-dwelling older persons with prefrailty. Findings can provide insights into the consideration of incorporating frailty prevention programs into the routine practice of community elderly services.",2020,"Participants in the intervention group also had a greater reduction in the combined frailty score and greater improvements in muscle endurance, balance, verbal fluency, attention and memory, executive function, and self-rated health than those in the control group (all P < .05).","['Prefrail Community-Dwelling Older Persons', 'A community elderly center in Hong Kong', 'The mean age of the participants was 62.2\xa0years, and 88.2% were women', 'Persons aged ≥50\xa0years who scored 1-2 on a simple frailty questionnaire (FRAIL) METHODS: Participants (n\xa0= 127', 'community-dwelling older persons with prefrailty']","['Multicomponent Frailty Prevention Program', 'multicomponent frailty prevention program', 'multicomponent frailty prevention program (exercise, cognitive training, board game activities) or to a wait-list control group']","['verbal fluency assessed by dual-task gait speed, attention and memory assessed by digit span task, executive function assessed by the Frontal Assessment Battery, self-rated health, and life satisfaction', 'FRAIL score', 'FRAIL scores, frailty status, and a combined frailty measure including subjective (FRAIL total score) and objective (grip strength, muscle endurance, balance, gait speed) measures', 'grip strength, gait speed, and life satisfaction', 'combined frailty score', 'frailty and improved physical and cognitive functions, and self-rated health', 'muscle endurance, balance, verbal fluency, attention and memory, executive function, and self-rated health']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.0356679,"Participants in the intervention group also had a greater reduction in the combined frailty score and greater improvements in muscle endurance, balance, verbal fluency, attention and memory, executive function, and self-rated health than those in the control group (all P < .05).","[{'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Jockey Club Institute of Ageing, Chinese University of Hong Kong, Hong Kong SAR, China; Department of Medicine and Therapeutics, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong SAR, China. Electronic address: rubyyu@cuhk.edu.hk.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Jockey Club Institute of Ageing, Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ho', 'Affiliation': 'Jockey Club Cadenza Hub, Hong Kong SAR, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Jockey Club Institute of Ageing, Chinese University of Hong Kong, Hong Kong SAR, China; Department of Medicine and Therapeutics, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong SAR, China.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.08.024']
3423,31805806,Comprehensive Migraine Initiative in the Pediatric Emergency Department Improves Treatment Outcomes.,"OBJECTIVE


To compare pediatric migraine treatment efficacy in the emergency department before and after the implementation of a comprehensive migraine initiative, consisting of a standardized treatment protocol, provider educational series and standardized physician documentation template.
BACKGROUND


Pediatric migraine is common, accounting for 1% of pediatric emergency department visits. Yet there is large variability in treatment practices, with few studies looking into measures of both clinical effectiveness and timeliness of treatment following implementation of standardized protocols.
METHODS


A single-center retrospective chart review of pediatric patients presenting to the emergency department with migraine before and after implementation of an institutional headache initiative designed to more effectively and efficiently deliver care to pediatric migraine patients.
RESULTS


The study yielded 110 patients each in the intervention and preintervention groups. There were no significant differences in patient characteristics with respect to age, gender, or initial pain score. Compared with the preintervention group, the intervention group demonstrated a significant reduction in headache pain score prior to discharge (decrease of 5.9 vs 4.8 in preintervention group,  P  value .006) with a greater percentage of patients achieving ≥50% reduction in pain (82% vs 67% in preintervention group,  P  value .039). Additionally, we found a significantly decreased time to treatment in the intervention group compared with the preintervention group (1.8 vs 2.1 hours,  P  value .046).
CONCLUSION


Through the use of a standardized treatment protocol, improved provider education, and ease of documentation, this comprehensive migraine initiative improved efficacy and efficiency of migraine treatment in the pediatric emergency department.",2020,"Compared with the preintervention group, the intervention group demonstrated a significant reduction in headache pain score prior to discharge (decrease of 5.9 vs 4.8 in preintervention group,  P  value .006) with a greater percentage of patients achieving ≥50% reduction in pain (82% vs 67% in preintervention group,  P  value .039).","['pediatric patients presenting to the emergency department with migraine before and after implementation of an institutional headache initiative designed to more effectively and efficiently deliver care to pediatric migraine patients', 'pediatric emergency department', '110 patients each in the intervention and preintervention groups']",[],"['headache pain score prior to discharge', 'pain', 'efficacy and efficiency', 'patient characteristics with respect to age, gender, or initial pain score']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",110.0,0.0250561,"Compared with the preintervention group, the intervention group demonstrated a significant reduction in headache pain score prior to discharge (decrease of 5.9 vs 4.8 in preintervention group,  P  value .006) with a greater percentage of patients achieving ≥50% reduction in pain (82% vs 67% in preintervention group,  P  value .039).","[{'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Skora', 'Affiliation': 'Department of Pediatric Neurology, Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Lila T', 'Initials': 'LT', 'LastName': 'Worden', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Chris B', 'Initials': 'CB', 'LastName': 'Oakley', 'Affiliation': 'Department of Pediatric Neurology, Johns Hopkins Hospital, Baltimore, MD, USA.'}]",Journal of child neurology,['10.1177/0883073819889711']
3424,31679347,Designing and Evaluating an Empowering Program for Breastfeeding: A Mixed-Methods Study.,"BACKGROUND


Breastfeeding empowerment is a key motivational, psychological and flexible factor influencing the continuance of breastfeeding. The purpose of this mixed-methods study was to design and evaluate the empowering program for breastfeeding.
METHODS


We used a mixed-methods study with a sequential exploratory approach. In the qualitative phase, we explored the experiences of women about empowerment for breastfeeding using conventional content analysis. In the intervention phase, we designed and implemented a breastfeeding empowerment program based on the findings of the qualitative phase and evaluated it 2 weeks, 2 months and 4 months after childbirth. This randomized clinical trial is registered under IRCT2015081723657N1.
RESULTS


Analysis of data from the interviews in the qualitative phase yielded three main categories, namely ""adequate knowledge and skills about breastfeeding"", ""overcoming breastfeeding problems"" and ""perception of family support for breastfeeding"". In the qualitative phase, after implementing the program, the mean scores of breastfeeding empowerment were significantly higher in the intervention compared to the control group at 2 weeks (mean difference= -25.30; 95% CI = -5.36, -15.23), 2 months (mean difference = -21.71; 95% CI = -31.24, -12.19), and 4 months (mean difference = -17.72; 95% CI = -27.14, -8.30) after childbirth (P<0.001). In addition, exclusive breastfeeding was significantly higher in the intervention group at 2 weeks, 2 months and 4 months after childbirth (P=0.003, P=0.003, P=0.044, respectively).
CONCLUSION


To empower women for breastfeeding, the mother, father and key family members should be educated using practical and visual teaching techniques during pregnancy and postpartum period. Moreover, since breastfeeding empowerment is established 2 weeks after childbirth, empowering programs should be implemented prior to this period.",2019,"In addition, exclusive breastfeeding was significantly higher in the intervention group at 2 weeks, 2 months and 4 months after childbirth (P=0.003, P=0.003, P=0.044, respectively).
",['Breastfeeding'],[],"['exclusive breastfeeding', 'mean scores of breastfeeding empowerment']","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]",[],"[{'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",,0.0747999,"In addition, exclusive breastfeeding was significantly higher in the intervention group at 2 weeks, 2 months and 4 months after childbirth (P=0.003, P=0.003, P=0.044, respectively).
","[{'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Kohan', 'Affiliation': 'Midwifery and Reproductive Health Department, Nursing & Midwifery Care Research Center, Faculty of Nursing & Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahrokh', 'Initials': 'M', 'LastName': 'Keshvari', 'Affiliation': 'Nursing & Midwifery Care Research Center, Faculty of Nursing & Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Nursing & Midwifery Care Research Center, Faculty of Nursing & Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Nursing & Midwifery Care Research Center, Faculty of Nursing & Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Archives of Iranian medicine,[]
3425,31217176,Immune Complexes and the Risk of CVD in Type 1 Diabetes.,"We investigated whether the composition of modified forms of LDL in circulating immune complexes (LDL-ICs) was associated with cardiovascular disease (CVD) outcomes, including any CVD, major adverse cardiac and cerebrovascular events (MACCE), myocardial infarction (MI), and coronary artery disease, in type 1 diabetes (T1D). Our results demonstrate that the baseline levels of oxidized LDL (oxLDL), MDA-modified LDL (MDA-LDL), and advanced glycosylation-modified LDL (AGE-LDL) in circulating ICs were associated with the four CVD outcomes in unadjusted models, and adjustment by age and mean HbA 1c  only resulted in minimal reduction of these associations. After adjustments were made for other cardiovascular risk factors, particularly LDL cholesterol, oxLDL-IC and MDA-LDL-IC remained independently associated with the risk of CVD, and oxLDL-IC was independently associated with the risk of MACCE and MI. In the majority of cases, the baseline levels of modified LDL-IC (measured many years before the occurrence of any CVD event) were associated with the risk of CVD over a 25-year period even after adjustment for other risk factors (including LDL cholesterol). Therefore, modified LDL biomarkers may help identify patients with T1D at high risk for MACCE and CVD events very early in the evolution of the disease, before other signals of disease are apparent.",2019,"Our results demonstrate that the baseline levels of oxidized LDL (oxLDL), MDA-modified LDL (MDA-LDL), and advanced glycosylation-modified LDL (AGE-LDL) in circulating ICs were associated with the four CVD outcomes in unadjusted models, and adjustment by age and mean HbA 1c  only resulted in minimal reduction of these associations.",[],[],"['cardiovascular disease (CVD) outcomes, including any CVD, major adverse cardiac and cerebrovascular events (MACCE), myocardial infarction (MI), and coronary artery disease, in type 1 diabetes (T1D', 'baseline levels of modified LDL-IC', 'oxidized LDL (oxLDL), MDA-modified LDL (MDA-LDL), and advanced glycosylation-modified LDL (AGE-LDL', 'cardiovascular risk factors, particularly LDL cholesterol, oxLDL-IC and MDA-LDL-IC']",[],[],"[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0017982'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",,0.0474738,"Our results demonstrate that the baseline levels of oxidized LDL (oxLDL), MDA-modified LDL (MDA-LDL), and advanced glycosylation-modified LDL (AGE-LDL) in circulating ICs were associated with the four CVD outcomes in unadjusted models, and adjustment by age and mean HbA 1c  only resulted in minimal reduction of these associations.","[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Lopes-Virella', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD.'}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Hunt', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Virella', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Braffett', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD jml@bsc.gwu.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0358']
3426,32059587,"Effectiveness of An Educational Intervention of Breast Cancer Screening Practices Uptake, Knowledge, and Beliefs among Yemeni Female School Teachers in Klang Valley, Malaysia: A Study Protocol for a Cluster-Randomized Controlled Trial.","Breast cancer is the most common cancer spread among women worldwide. Whereas many studies have discussed the significance of breast cancer screening among women in various countries, few have attempted to discuss this topic among female school teachers. As teachers educate and communicate with students, this may play an essential role in health education and in promoting healthy behavior, such as breast cancer screening. The primary goal of this study is to develop and implement an educational intervention of breast cancer screening and evaluate its effectiveness among Yemeni female school teachers in Malaysia. This was carried out as per the health belief model. A cluster-randomized controlled trial was conducted among 183 Yemeni female school teachers in twelve schools in Klang Valley, Malaysia. A random assignment of the target schools was made to include them within the intervention or control group. Participants in the intervention group were offered a 90-minute session for one-day educational intervention on breast cancer screening. On the other hand, participants in the control group were offered the same educational materials at the end of the study. Relevant data was collected at baseline, one month following the intervention, and then three- and six-months follow-up assessments. Analysis of such data was done via IBM SPSS software 25.0 by generalized estimating equations (GEE) to assess the differential changes over time. A primary outcome embodied in breast cancer screening practice uptake was expected. Secondary outcomes include the target group's knowledge on and beliefs of breast cancer screening. This study intends to contribute to the credibility and effectiveness of utilizing a theory-based breast cancer screening intervention in order to raise the awareness of women on conducting breast cancer screening.",2020,Analysis of such data was done via IBM SPSS software 25.0 by generalized estimating equations (GEE) to assess the differential changes over time.,"['Yemeni female school teachers in Malaysia', 'female school teachers', 'Yemeni Female School Teachers in Klang Valley, Malaysia', '183 Yemeni female school teachers in twelve schools in Klang Valley, Malaysia', 'women on conducting breast cancer screening']","['educational intervention of breast cancer screening', 'utilizing a theory-based breast cancer screening intervention', '90-minute session for one-day educational intervention on breast cancer screening', 'Educational Intervention']","['breast cancer screening practice uptake', ""target group's knowledge on and beliefs of breast cancer screening""]","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0036374', 'cui_str': 'School Teachers'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}]","[{'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",183.0,0.0236397,Analysis of such data was done via IBM SPSS software 25.0 by generalized estimating equations (GEE) to assess the differential changes over time.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Noman', 'Affiliation': 'Department of Community Health, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Hayati Kadir', 'Initials': 'HK', 'LastName': 'Shahar', 'Affiliation': 'Department of Community Health, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Hejar', 'Initials': 'H', 'LastName': 'Abdul Rahman', 'Affiliation': 'Department of Community Health, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}, {'ForeName': 'Suriani', 'Initials': 'S', 'LastName': 'Ismail', 'Affiliation': 'Department of Community Health, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17041167']
3427,31841577,Acyclovir for Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation: A Randomized Clinical Trial.,"Importance


The role of herpes simplex virus (HSV) reactivation on morbidity and mortality in patients in the intensive care unit requiring mechanical ventilation remains unknown.
Objective


To determine whether preemptive treatment with intravenous acyclovir reduces the duration of mechanical ventilation in patients with HSV oropharyngeal reactivation.
Design, Setting, and Participants


A double-blind, placebo-controlled randomized clinical trial was conducted in 16 intensive care units in France. Participants included 239 adults (age, >18 years) who received mechanical ventilation for at least 96 hours and continued to receive mechanical ventilation for 48 hours or more, with HSV oropharyngeal reactivation. Patients were enrolled between February 2, 2014, and February 22, 2018.
Interventions


Participants were randomized to receive intravenous acyclovir, 5 mg/kg, 3 times daily for 14 days or a matching placebo.
Main Outcomes and Measures


The primary end point was ventilator-free days from randomization to day 60. Prespecified secondary outcomes included mortality at 60 days. Main analyses were conducted on an intention-to-treat basis.
Results


Of 239 patients enrolled and randomized, 1 patient withdrew consent, leaving 238 patients, with 119 patients in both the acyclovir and placebo (control) groups (median [IQR] age, 61 [50-70] years; 76 [32%] women) available for primary outcome measurement. On day 60, the median (IQR) numbers of ventilator-free days were 35 (0-53) for acyclovir recipients and 36 (0-50]) for controls (P = .17 for between-group comparison). Among secondary outcomes, 26 patients (22%) and 39 patients (33%) had died at day 60 (risk difference, 0.11, 95% CI, -0.004 to 0.22, P = .06). The adverse event frequency was similar for both groups (28% in the acyclovir group and 23% in the placebo group, P = .40), particularly acute renal failure post randomization affecting 3 acyclovir recipients (3%) and 2 controls (2%). Four patients (3%) in the acyclovir group vs none in the placebo group stopped the study drug for treatment-related adverse events.
Conclusions and Relevance


In patients receiving mechanical ventilation for 96 hours or more with HSV reactivation in the throat, use of acyclovir, 5 mg/kg, 3 times daily for 14 days, did not increase the number of ventilator-free days at day 60, compared with placebo. These findings do not appear to support routine preemptive use of acyclovir in this setting.
Trial Registration


ClinicalTrials.gov identifier: NCT02152358.",2020,"The adverse event frequency was similar for both groups (28% in the acyclovir group and 23% in the placebo group, P = .40), particularly acute renal failure post randomization affecting 3 acyclovir recipients (3%) and 2 controls (2%).","['16 intensive care units in France', 'control) groups (median [IQR] age, 61 [50-70] years; 76 [32%] women) available for primary outcome measurement', 'patients with HSV oropharyngeal reactivation', 'Participants included 239 adults (age, >18 years) who received', 'for 48 hours or more, with HSV oropharyngeal reactivation', 'Patients were enrolled between February 2, 2014, and February 22, 2018', '239 patients enrolled and randomized, 1 patient withdrew consent, leaving 238 patients, with 119 patients in both the', 'patients in the intensive care unit requiring mechanical ventilation remains unknown', 'Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation']","['herpes simplex virus (HSV) reactivation', 'acyclovir', 'acyclovir and placebo', 'mechanical ventilation for at least 96 hours and continued to receive mechanical ventilation', 'placebo', 'Acyclovir', 'intravenous acyclovir', 'mechanical ventilation']","['acute renal failure', 'number of ventilator-free days', 'mortality', 'duration of mechanical ventilation', 'morbidity and mortality', 'adverse event frequency', 'median (IQR) numbers of ventilator-free days']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0042776', 'cui_str': 'Virus'}]","[{'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",239.0,0.632809,"The adverse event frequency was similar for both groups (28% in the acyclovir group and 23% in the placebo group, P = .40), particularly acute renal failure post randomization affecting 3 acyclovir recipients (3%) and 2 controls (2%).","[{'ForeName': 'Charles-Edouard', 'Initials': 'CE', 'LastName': 'Luyt', 'Affiliation': 'Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Forel', 'Affiliation': 'Médecine Intensive Réanimation, Aix-Marseille Université, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie, Paris, France.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Réanimation Chirurgicale, Centre Hospitalier Universitaire de Montpellier, Hôpital St-Eloi, Montpellier, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cayot-Constantin', 'Affiliation': 'Département de médecine periopératoire, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmelé', 'Affiliation': 'Réanimation Chirurgicale, Hôpital Edouard-Herriot, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Coupez', 'Affiliation': 'Réanimation Médicale, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Réanimation Chirurgicale Polyvalente, Département d'Anesthésie-Réanimation, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Mamadou Hassimiou', 'Initials': 'MH', 'LastName': 'Diallo', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière Charles Foix, Unité de Recherche Clinique, Paris, France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Penot-Ragon', 'Affiliation': 'Pharmacie, Hôpitaux Sud, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clavel', 'Affiliation': 'Réanimation Polyvalente, Centre Hospitalier Universitaire Dupuytren, Limoges, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Schwebel', 'Affiliation': 'Médecine Intensive Réanimation, Centre Hospitalier Universitaire Grenoble Alpes, La Tronche, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bedos', 'Affiliation': 'Service de Réanimation, Hôpital Mignot, Versailles, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hauw-Berlemont', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Réanimation des Urgences et Médicale, Aix-Marseille Université, Hôpital Timone, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mayaux', 'Affiliation': 'Pneumologie, Médecine Intensive Réanimation, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Réanimation Chirurgicale, Centre Hospitalier Universitaire Nîmes, Nîmes, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Combes', 'Affiliation': 'Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Réanimation Neurochirurgicale, Hôpital Sainte-Anne, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Chastre', 'Affiliation': 'Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Papazian', 'Affiliation': 'Médecine Intensive Réanimation, Aix-Marseille Université, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5713']
3428,30952500,"Kinetics of maternally-derived serogroup A, C, Y and W-specific meningococcal immunoglobulin G in Malian women and infants.","A prospective, randomised, controlled observer-blind trial measuring the efficacy and immunogenicity of trivalent influenza vaccine (TIV) and the immunogenicity of quadrivalent meningococcal conjugate vaccine (MCV) in pregnant women and their infants up to 6 months of age was conducted in Mali. Here we reported the immunogenicity of MCV, which was used as a comparator vaccine to TIV, in this population. Third-trimester pregnant Malian women were randomized to receive TIV or MCV. Blood samples were collected from women prior to vaccination, 28 days post-vaccination, at delivery and 3 and 6 months post-delivery and from infants at birth and 3 and 6 months of age. Meningococcal-specific serogroup (Men) A, C, Y and W-specific antibodies were measured by enzyme linked immunosorbent assay in a randomly selected subset of 50 mother-infant pairs where the mother had received MCV. At birth, 94.0% (47/50) of infants had MenA specific IgG levels ≥ 2 µg/mL decreasing to 72.9% and 30.4% at 3 and 6 months of age. For MenC, 81.3% (39/48) of infants had MenC specific IgG levels ≥ 2 µg/mL at birth decreasing to 29.4% and 17.8% at 3 and 6 months of age. For MenY, 89.6% (43/48) of infants had MenY specific IgG levels ≥ 2 µg/mL at birth decreasing to 64.6% and 62.5% at 3 and 6 months of age. For MenW, 89.6% (43/48) of infants had MenW specific IgG levels ≥ 2 μg/ml at birth decreasing to 62.5% and 41.7% at 3 and 6 months of age. Maternal immunization with MCV conveyed protective levels of IgG at birth through to 3 months of age in the majority of infants.",2019,"For MenY, 89.6% (43/48) of infants had MenY specific IgG levels ≥ ","['pregnant women and their infants up to 6\u202fmonths of age was conducted in Mali', 'Third-trimester pregnant Malian women', 'Malian women and infants']","['TIV or MCV', 'trivalent influenza vaccine (TIV', 'MCV', 'quadrivalent meningococcal conjugate vaccine (MCV']",['MenC specific IgG levels\u202f≥'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1961129', 'cui_str': 'Microvolt'}, {'cui': 'C0770694'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.121359,"For MenY, 89.6% (43/48) of infants had MenY specific IgG levels ≥ ","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Findlow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK. Electronic address: helenfindlow@hotmail.com.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Haidara', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Coulibaly', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Keita', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Diallo', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Doumbia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Traore', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schluterman', 'Affiliation': 'Department of Epidemiology, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Clark', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Levine', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.03.045']
3429,31378074,Benefit of Digital Tools Used for Integrated Personalized Diabetes Management: Results From the PDM-ProValue Study Program.,"BACKGROUND


Integrated personalized diabetes management (iPDM) is a digitally supported therapeutic concept to improve patient-physician interaction to overcome the aspects of clinical inertia. Integrated personalized diabetes management can support decision making and improve therapeutic outcomes of suboptimally controlled persons with insulin-treated type 2 diabetes (T2D). In this paper, we report the results of an analysis of the PDM-ProValue study program on the effectiveness and perceived benefit of this approach, with a focus on how physicians used and assessed the digital tools provided for the iPDM process.
MATERIALS AND METHODS


The study program included two 12-month, prospective, controlled, cluster-randomized multicenter trials. A total of 101 practices participated with 907 patients. Practices were cluster-randomized to an intervention group and a control group. Digital tools for data visualization and analysis applied were used. HCP were asked to assess the use, relevance, and usefulness of the tools.
RESULTS


A clear preference was stated for the visual overview over more statistically complex analyses. A total of 83% of the participants rated a high relevance of the ""daily profile,"" 81% of the ""total profile,"" and 68% the ""risk illustrated by traffic light symbols"" for the therapy decision. The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP).
CONCLUSIONS


Embedding digital tools in a structured process (iPDM) were proved to provide a benefit for insulin-treated T2D patients and their physicians. These results offer insight for further development and improvement of the tools and add information on how to overcome clinical inertia.",2020,"The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP).
","['patients and their physicians', 'A total of 101 practices participated with 907 patients', 'suboptimally controlled persons with insulin-treated type 2 diabetes (T2D']",['insulin-treated T2D'],['overall iPDM process'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",907.0,0.0266648,"The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP).
","[{'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Heinemann', 'Affiliation': 'Science Consulting in Diabetes GmbH, Neuss, Germany.'}, {'ForeName': 'Wendelin', 'Initials': 'W', 'LastName': 'Schramm', 'Affiliation': 'GECKO Institut, Hochschule Heilbronn, Germany.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Koenig', 'Affiliation': 'Roche Diabetes Care GmbH, Mannheim, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Moritz', 'Affiliation': 'Roche Diabetes Care Deutschland GmbH, Mannheim, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Vesper', 'Affiliation': 'Roche Diabetes Care GmbH, Mannheim, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Weissmann', 'Affiliation': 'Roche Diabetes Care Deutschland GmbH, Mannheim, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kulzer', 'Affiliation': 'FIDAM (Forschungsinstitut Diabetes Akademie Bad Mergentheim), Bad Mergentheim, Germany.'}]",Journal of diabetes science and technology,['10.1177/1932296819867686']
3430,30864279,Early Postnatal Changes of Bone Turnover Biomarkers in Very Low-Birth-Weight Neonates-The Effect of Two Parenteral Lipid Emulsions with Different Polyunsaturated Fatty Acid Content: A Randomized Double-Blind Study.,"BACKGROUND


ω-3 polyunsaturated fatty acids (n-3 PUFAs) are reported to have beneficial effect on bone mineral density. This study aimed to evaluate early changes of bone turnover biomarkers in very low-birth-weight (VLBW) neonates and the effect of 2 parenteral lipid emulsions (PLEs) with different PUFA composition.
METHODS


This is a randomized double-blind study with parallel design. VLBW neonates (n = 66) receiving parenteral nutrition (PN)>70% of daily energy requirements for >14 days were assigned into 2 groups that were prescribed soybean oil-based (n = 35) and n-3-enriched PLE (n = 31), respectively. Osteoprotegerin (OPG), soluble receptor activator of nuclear factor-kB ligand (sRANKL), osteocalcin (OC), interleukin-6 (enzyme-linked immunoblot assay kits), Ca, and P plasma levels were assessed before PLE implementation (T1) and on day 20 of life (T2).
RESULTS


In the total population, sRANKL and OC significantly increased, whereas OPG and the OPG/sRANKL ratio decreased from T1 to T2. Within each group, T1-to-T2 changes of OC were significant in both groups, whereas those of OPG/sRANKL were significant only in the soybean-based group. Multiple regressions showed an independent effect of group allocation on OPG change. Significant associations were observed between PN duration and sRANKL change (negatively), n-6/n-3 and OC changes (positively), and OPG and sRANKL changes (positively).
CONCLUSIONS


A high bone-turnover rate in VLBW neonates with predominance of bone resorption is confirmed. The lower rate of OPG/sRANKL reduction in the n-3-enriched PLE group indicates that n-3 PUFA-enriched PLEs may help to attenuate early bone loss in VLBW neonates.",2020,"Osteoprotegerin (OPG), soluble receptor activator of nuclear factor-kB ligand (sRANKL), osteocalcin (OC), interleukin-6 (enzyme-linked immunoblot assay kits), Ca, and P plasma levels were assessed before PLE implementation (T1) and on day 20 of life (T2).
","['Very Low-Birth-Weight Neonates', 'VLBW neonates (n = 66) receiving', 'very low-birth-weight (VLBW) neonates']","['soybean oil-based (n = 35) and n-3-enriched PLE', 'n-3 PUFA-enriched PLEs', 'ω-3 polyunsaturated fatty acids (n-3 PUFAs', 'Two Parenteral Lipid Emulsions with Different Polyunsaturated Fatty Acid Content', 'parenteral lipid emulsions (PLEs', 'parenteral nutrition (PN)>70% of daily energy requirements']","['bone turnover biomarkers', 'OPG change', 'T1-to-T2 changes of OC', 'Osteoprotegerin (OPG), soluble receptor activator of nuclear factor-kB ligand (sRANKL), osteocalcin (OC), interleukin-6 (enzyme-linked immunoblot assay kits), Ca, and P plasma levels', 'PN duration and sRANKL change (negatively), n-6/n-3 and OC changes (positively), and OPG and sRANKL changes (positively', 'lower rate of OPG/sRANKL reduction', 'OPG and the OPG/sRANKL ratio']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449200', 'cui_str': 'PLE (body structure)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement (observable entity)'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262886', 'cui_str': 'Osteoprotegerin'}, {'cui': 'C4543210', 'cui_str': 'Receptor activator (disposition)'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0020985', 'cui_str': 'Immunoblotting'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1262245', 'cui_str': 'sRANKL'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",66.0,0.214206,"Osteoprotegerin (OPG), soluble receptor activator of nuclear factor-kB ligand (sRANKL), osteocalcin (OC), interleukin-6 (enzyme-linked immunoblot assay kits), Ca, and P plasma levels were assessed before PLE implementation (T1) and on day 20 of life (T2).
","[{'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Papandreou', 'Affiliation': 'First Department of Pediatrics, Athens University Medical School, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Agakidis', 'Affiliation': 'First Department of Pediatrics, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Scouroliakou', 'Affiliation': 'Harokopio University, Athens, Greece.'}, {'ForeName': 'Thomai', 'Initials': 'T', 'LastName': 'Karagiozoglou-Lampoudi', 'Affiliation': 'Clinical Nutrition Lab, Nutrition/Dietetics Department, Alexander Technological Education Institute, Thessaloniki, Greece.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Kaliora', 'Affiliation': 'Harokopio University, Athens, Greece.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Harokopio University, Athens, Greece.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Siahanidou', 'Affiliation': 'First Department of Pediatrics, Athens University Medical School, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1533']
3431,31030981,Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial.,"BACKGROUND


Guidelines recommend the use of nutritional support during hospital stays for medical patients (patients not critically ill and not undergoing surgical procedures) at risk of malnutrition. However, the supporting evidence for this recommendation is insufficient, and there is growing concern about the possible negative effects of nutritional therapy during acute illness on recovery and clinical outcomes. Our aim was thus to test the hypothesis that protocol-guided individualised nutritional support to reach protein and caloric goals reduces the risk of adverse clinical outcomes in medical inpatients at nutritional risk.
METHODS


The Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) is a pragmatic, investigator-initiated, open-label, multicentre study. We recruited medical patients at nutritional risk (nutritional risk screening 2002 [NRS 2002] score ≥3 points) and with an expected length of hospital stay of more than 4 days from eight Swiss hospitals. These participants were randomly assigned (1:1) to receive either protocol-guided individualised nutritional support to reach protein and caloric goals (intervention group) or standard hospital food (control group). Randomisation was done with variable block sizes and stratification according to study site and severity of malnutrition using an interactive web-response system. In the intervention group, individualised nutritional support goals were defined by specialist dietitians and nutritional support was initiated no later than 48 h after admission. Patients in the control group received no dietary consultation. The composite primary endpoint was any adverse clinical outcome defined as all-cause mortality, admission to intensive care, non-elective hospital readmission, major complications, and decline in functional status at 30 days, and it was measured in all randomised patients who completed the trial. This trial is registered with ClinicalTrials.gov, number NCT02517476.
FINDINGS


5015 patients were screened, and 2088 were recruited and monitored between April 1, 2014, and Feb 28, 2018. 1050 patients were assigned to the intervention group and 1038 to the control group. 60 patients withdrew consent during the course of the trial (35 in the intervention group and 25 in the control group). During the hospital stay, caloric goals were reached in 800 (79%) and protein goals in 770 (76%) of 1015 patients in the intervention group. By 30 days, 232 (23%) patients in the intervention group experienced an adverse clinical outcome, compared with 272 (27%) of 1013 patients in the control group (adjusted odds ratio [OR] 0·79 [95% CI 0·64-0·97], p=0·023). By day 30, 73 [7%] patients had died in the intervention group compared with 100 [10%] patients in the control group (adjusted OR 0·65 [0·47-0·91], p=0·011). There was no difference in the proportion of patients who experienced side-effects from nutritional support between the intervention and the control group (162 [16%] vs 145 [14%], adjusted OR 1·16 [0·90-1·51], p=0·26).
INTERPRETATION


In medical inpatients at nutritional risk, the use of individualised nutritional support during the hospital stay improved important clinical outcomes, including survival, compared with standard hospital food. These findings strongly support the concept of systematically screening medical inpatients on hospital admission regarding nutritional risk, independent of their medical condition, followed by a nutritional assessment and introduction of individualised nutritional support in patients at risk.
FUNDING


The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau, Switzerland.",2019,"There was no difference in the proportion of patients who experienced side-effects from nutritional support between the intervention and the control group (162 [16%] vs 145 [14%], adjusted OR 1·16","['medical inpatients at nutritional risk', '0·79', 'medical patients (patients not critically ill and not undergoing surgical procedures) at risk of malnutrition', 'medical patients at nutritional risk (nutritional risk screening 2002 [NRS 2002] score ≥3 points) and with an expected length of hospital stay of more than 4 days from eight Swiss hospitals', '60 patients withdrew consent during the course of the trial (35 in the intervention group and 25 in the control group', 'patients at risk', '1050 patients', '5015 patients were screened, and 2088 were recruited and monitored between April 1, 2014, and Feb 28, 2018']","['Individualised nutritional support', 'protocol-guided individualised nutritional support to reach protein and caloric goals (intervention group) or standard hospital food (control group', 'early nutritional support', 'no dietary consultation']","['protein goals', 'adverse clinical outcome', 'hospital stay, caloric goals', 'adverse clinical outcome defined as all-cause mortality, admission to intensive care, non-elective hospital readmission, major complications, and decline in functional status']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0085559'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4304688', 'cui_str': 'Decline in functional status'}]",5015.0,0.0851974,"There was no difference in the proportion of patients who experienced side-effects from nutritional support between the intervention and the control group (162 [16%] vs 145 [14%], adjusted OR 1·16","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Basel, Switzerland. Electronic address: philipp.schuetz@unibas.ch.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fehr', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Baechli', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Geiser', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Deiss', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; The New York Academy of Sciences, New York, NY, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Internal Medicine, Spital Lachen, Lachen, Switzerland; Department of Health Professions, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bregenzer', 'Affiliation': 'Internal Medicine, Spital Lachen, Lachen, Switzerland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Braun', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hoess', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Pavlicek', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Internal Medicine, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bilz', 'Affiliation': 'Internal Medicine and Endocrinology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sigrist', 'Affiliation': 'Internal Medicine and Endocrinology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brändle', 'Affiliation': 'Internal Medicine and Endocrinology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Benz', 'Affiliation': 'Internal Medicine and Endocrinology, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henzen', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Luzern, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mattmann', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Luzern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thomann', 'Affiliation': 'Internal Medicine, Bürgerspital Solothurn, Solothurn, Switzerland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Brand', 'Affiliation': 'Internal Medicine, Bürgerspital Solothurn, Solothurn, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Internal Medicine, Kantonsspital Baselland, Standort Bruderholz Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': ""Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetology, Endocrinology, Nutritional Medicine, and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Basel, Switzerland.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)32776-4']
3432,30861061,"Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial.","BACKGROUND


ZTI-01 (fosfomycin for injection) is an epoxide antibiotic with a differentiated mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis. ZTI-01 has broad in vitro spectrum of activity, including multidrug-resistant Gram-negative pathogens, and is being developed for treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) in the United States.
METHODS


Hospitalized adults with suspected or microbiologically confirmed cUTI/AP were randomized 1:1 to 6 g ZTI-01 q8h or 4.5 g intravenous (IV) piperacillin-tazobactam (PIP-TAZ) q8h for a fixed 7-day course (no oral switch); patients with concomitant bacteremia could receive up to 14 days.
RESULTS


Of 465 randomized patients, 233 and 231 were treated with ZTI-01 and PIP-TAZ, respectively. In the microbiologic modified intent-to-treat (m-MITT) population, ZTI-01 met the primary objective of noninferiority compared with PIP-TAZ with overall success rates of 64.7% (119/184 patients) vs 54.5% (97/178 patients), respectively; treatment difference was 10.2% (95% confidence interval [CI]: -0.4, 20.8). Clinical cure rates at test of cure (TOC, day 19-21) were high and similar between treatments (90.8% [167/184] vs 91.6% [163/178], respectively). In post hoc analysis using unique pathogens typed by pulsed-field gel electrophoresis, overall success rates at TOC in m-MITT were 69.0% (127/184) for ZTI-01 versus 57.3% (102/178) for PIP-TAZ (difference 11.7% 95% CI: 1.3, 22.1). ZTI-01 was well tolerated. Most treatment-emergent adverse events, including hypokalemia and elevated serum aminotransferases, were mild and transient.
CONCLUSIONS


ZTI-01 was effective for treatment of cUTI including AP and offers a new IV therapeutic option with a differentiated MOA for patients with serious Gram-negative infections.
CLINICAL TRIAL REGISTRATION


NCT02753946.",2019,"Clinical cure rates at test-of-cure (TOC, Day 19-21) were high and similar between treatments (90.8% [167/184] vs 91.6% [163/178], respectively).","['Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP', 'Hospitalized adults with suspected or microbiologically confirmed cUTI/AP', 'patients with serious Gramnegative infections', 'Of 465 randomized patients, 233 and 231 were treated with ZTI-01 and PIP-TAZ, respectively']","['ZEUS', 'PIP-TAZ', 'ZTI-01 q8h or 4.5 g IV piperacillin-tazobactam (PIP-TAZ', 'Fosfomycin for injection (ZTI-01) vs Piperacillin-Tazobactam (PIP-TAZ']","['overall success rates', 'Clinical cure rates', 'hypokalemia and elevated serum aminotransferases', 'tolerated']","[{'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0250480', 'cui_str': 'Piperacillin / tazobactam'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}]",465.0,0.178605,"Clinical cure rates at test-of-cure (TOC, Day 19-21) were high and similar between treatments (90.8% [167/184] vs 91.6% [163/178], respectively).","[{'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Louis B', 'Initials': 'LB', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Warren Alpert Medical School of Brown University and Rhode Island Hospital and The Miriam Hospital, Providence.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Dane', 'Affiliation': 'DaneStat Consulting, Alderly Edge, United Kingdom.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Stus', 'Affiliation': 'Municipal Institution Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine, Dnipro.'}, {'ForeName': 'Olexiy', 'Initials': 'O', 'LastName': 'Sagan', 'Affiliation': 'Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia, Regional Council Department of Urology, State Institution Zaporizhzhia Medical Academy of Postgraduate Education under the Ministry of Health of Ukraine.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fedosiuk', 'Affiliation': 'Brest Regional Hospital, Belarus.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'Das Statistical Consulting, Guerneville.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skarinsky', 'Affiliation': 'Zavante Therapeutics, Inc., San Diego, California.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Eckburg', 'Affiliation': 'Zavante Therapeutics, Inc., San Diego, California.'}, {'ForeName': 'Evelyn J', 'Initials': 'EJ', 'LastName': 'Ellis-Grosse', 'Affiliation': 'Zavante Therapeutics, Inc., San Diego, California.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz181']
3433,31881984,Influence of Early versus Late supplemental ParenteraL Nutrition on long-term quality of life in ICU patients after gastrointestinal oncological surgery (hELPLiNe): study protocol for a randomized controlled trial.,"BACKGROUND


Nutrition plays a major role in intensive care unit (ICU) treatment, influencing ICU length of stay and patient's survival. If preferable enteral nutrition administration is not feasible, ESPEN and ASPEN guidelines recommend initiation of a supplemental parenteral route between the first and seventh day, but exact timing remains elusive. While rapid development in critical care enabled significant reduction in the mortality rate of ICU patients, this improvement also tripled the number of patients going to rehabilitation. Thus, it is quality of life after ICU that has become the subject of interest of clinicians and healthcare policy-makers. A growing body of evidence indicates that protein turnover in the early phase of critical illness may play a crucial role in the preservation of lean body mass. A negative protein balance may lead to muscle wasting that persists weeks and months after ICU stay, resulting in deterioration of physical functioning. Folliwing oncological gastrointestinal tract surgery, patients are threatened with negative protein turnover due to cancer and extensive surgical insult.
METHODS


This is a multi-centre, single-blinded, randomised controlled trial. The study population includes patients admitted to ICU units after major oncological gastrointestinal surgery that require supplemental parenteral nutrition. After initiation of enteral nutrition, the intervention group receives remaining daily requirement via supplemental parenteral nutrition on the first day of ICU stay while the control group is not supplemented parenterally until the seventh day of ICU stay while enteral nutrition is gradually increased. Primary endpoint: long-term quality of life measured in the physical component score (PCS) of SF-36 questionnaire at 3 and 6 months after ICU admission.
DISCUSSION


To our knowledge, this is the first trial to investigate the influence of early supplemental parenteral nutrition on long-term quality of life after major oncological gastrointestinal surgery. We assume that, particularly in this population of patients, early supplemental parenteral nutrition may increase the long-term quality of life. The study construction also allows establishment of patients' PCS SF-36 score prior to surgery and mean change in PCS SF-36 score during the recovery period, which is rarely seen in studies on critically ill patients.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03699371 registered on 12 October 2018.",2019,"Primary endpoint: long-term quality of life measured in the physical component score (PCS) of SF-36 questionnaire at 3 and 6 months after ICU admission.
","['ICU patients after gastrointestinal oncological surgery (hELPLiNe', 'patients admitted to ICU units after major oncological gastrointestinal surgery that require supplemental parenteral nutrition', 'critically ill patients', 'life after major oncological gastrointestinal surgery']",['Late supplemental ParenteraL Nutrition'],"['term quality of life measured in the physical component score (PCS) of SF-36 questionnaire', 'long-term quality of life', 'PCS SF-36 score', 'mortality rate']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal Surgical Procedure'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}]","[{'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0710372,"Primary endpoint: long-term quality of life measured in the physical component score (PCS) of SF-36 questionnaire at 3 and 6 months after ICU admission.
","[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Piwowarczyk', 'Affiliation': 'II Department of Anesthesiology and Intensive Care, Medical University of Lublin, ul. Staszica 16, 20-081, Lublin, Poland. piwowarczyk.pawel@gmail.com.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Kutnik', 'Affiliation': ""Student's Scientific Association at II Department of Anesthesiology and Intensive Care, Medical University of Lublin, Lublin, Poland.""}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Borys', 'Affiliation': 'II Department of Anesthesiology and Intensive Care, Medical University of Lublin, ul. Staszica 16, 20-081, Lublin, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Rypulak', 'Affiliation': 'II Department of Anesthesiology and Intensive Care, Medical University of Lublin, ul. Staszica 16, 20-081, Lublin, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Potręć-Studzińska', 'Affiliation': 'II Department of Anesthesiology and Intensive Care, Medical University of Lublin, ul. Staszica 16, 20-081, Lublin, Poland.'}, {'ForeName': 'Justyna', 'Initials': 'J', 'LastName': 'Sysiak-Sławecka', 'Affiliation': 'II Department of Anesthesiology and Intensive Care, Medical University of Lublin, ul. Staszica 16, 20-081, Lublin, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Czarnik', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Opole University Hospital, Wincentego Witosa 26, 45-401, Opole, Poland.'}, {'ForeName': 'Mirosław', 'Initials': 'M', 'LastName': 'Czuczwar', 'Affiliation': 'II Department of Anesthesiology and Intensive Care, Medical University of Lublin, ul. Staszica 16, 20-081, Lublin, Poland.'}]",Trials,['10.1186/s13063-019-3796-3']
3434,30993855,"Efficacy and safety of a morning injection of insulin glargine 300 units/mL versus insulin glargine 100 units/mL in adult patients with type 1 diabetes: A multicentre, randomized controlled trial using continuous glucose monitoring.","Video abstract: View a video abstract for this article.
AIMS


This multicentre (N = 104), randomized controlled phase 4 study compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with insulin glargine 100 units/mL (Gla-100) in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS


Patients were randomized 1:1 to self-perform morning Gla-300 or Gla-100 injections daily for 16 weeks. The primary endpoint was percentage of time blood glucose remained in the target range (70-180 mg/dL) during Week 15/16, measured by blinded continuous glucose monitoring. Secondary endpoints included incidence and rate of nocturnal symptomatic hypoglycaemia (≤70 mg/dL), glycaemic variability parameters and safety assessments. Exploratory analyses were performed in patients with glycated haemoglobin (HbA1c) <7.5% at Week 16.
RESULTS


Overall, 638 patients with T1D were included (Gla-300, n = 320; Gla-100, n = 318). In the modified intent-to-treat (mITT) population, no differences between Gla-300 and Gla-100 were observed in time in range, in glycaemic variability, or in incidence or rates of nocturnal symptomatic hypoglycaemia. In exploratory analyses of patients with HbA1c <7.5% at Week 16, Gla-300 recipients had greater improvement in time in range over 24 hours, during the day and at night compared with Gla-100 recipients (P < 0.05), with small increases in overall hypoglycaemia.
CONCLUSIONS


Time in range and glycaemic variability were similar for Gla-300 and Gla-100 recipients at the end of study in the mITT population of relatively well-controlled patients with T1D. In patients with end-of-study HbA1c <7.5%, exploratory analyses suggested that Gla-300 provided improvements in time in range compared with Gla-100.",2019,"CONCLUSIONS


Time in range and glycaemic variability were similar for Gla-300 and Gla-100 recipients at the end of study in the mITT population of relatively well-controlled patients with T1D.","['638 patients with T1D were included (Gla-300, n =\u2009320; Gla-100, n =\u2009318', 'adult patients with type 1 diabetes', 'Patients were randomized 1:1 to self-perform morning', 'patients with type 1 diabetes (T1D', 'patients with glycated haemoglobin (HbA1c) <7.5% at Week 16']","['Gla-300 or Gla-100 injections', 'insulin glargine 300\u2009units/mL versus insulin glargine 100\u2009units/mL', 'continuous glucose monitoring', 'insulin glargine 300\u2009units/mL (Gla-300) with insulin glargine 100\u2009units/mL (Gla-100']","['percentage of time blood glucose', 'nocturnal symptomatic hypoglycaemia', 'Efficacy and safety', 'efficacy and safety', 'incidence and rate of nocturnal symptomatic hypoglycaemia (≤70\u2009mg/dL), glycaemic variability parameters and safety assessments', 'overall hypoglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",638.0,0.0769179,"CONCLUSIONS


Time in range and glycaemic variability were similar for Gla-300 and Gla-100 recipients at the end of study in the mITT population of relatively well-controlled patients with T1D.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Pettus', 'Affiliation': 'School of Medicine, University of California, San Diego, California.'}, {'ForeName': 'Jasvinder', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Sanofi US Inc, Bridgewater, New Jersey.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Paranjape', 'Affiliation': 'Sanofi US Inc, Bridgewater, New Jersey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi Canada, Laval, Canada.'}, {'ForeName': 'Shilpy', 'Initials': 'S', 'LastName': 'Malla', 'Affiliation': 'Sanofi US Inc, Bridgewater, New Jersey.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Edelman', 'Affiliation': 'School of Medicine, University of California, San Diego, California.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center, Park Nicollet and Health Partners, St. Louis Park, Minnesota.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, Georgia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13751']
3435,31977278,Short-term dynamic changes in neutralizing antibodies against enterovirus 71 after vaccination.,"BACKGROUND


Short-term dynamic changes in neutralizing antibodies against EV71 and EV71-IgM after inactivated EV71 vaccine injection are unknown.
METHODS


This study was designed as a randomized, open-label study and was registered at ClinicalTrials.gov (NCT03278132). In total, 120 healthy infants aged 6-35 months were randomized 1:1:1 to provide a second blood sample on day 10, day 20, or day 30 after the first vaccine dose, respectively.
RESULTS


According to the per-protocol set, a rapid immune response against EV71 was observed 10 days after the first EV71 vaccine dose, with antibody titers ≥1:8 in 89.19% of participants (95% CI: 74.58-96.97%) on day 10, in 80.65% (95% CI: 62.53-92.55%) on day 20, in 66.67% (95% CI: 49.03-81.44%) on day 30, and in 100% (95% CI: 96.52%-.) on day 60. Based on an ELISA, the percentages of participants positive for EV71-IgM on day 0 and day 60 were 1.71% (2 out of 117) and 82.86% (87 out of 105), respectively.
CONCLUSIONS


The EV71 vaccine could be used for contingency vaccination to further control EV71-associated disease outbreaks. Caution should be taken in using the EV71-IgM test for rapid EV71 infection diagnosis after EV71 vaccine administration.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03278132.",2020,Caution should be taken in using the EV71-IgM test for rapid EV71 infection diagnosis after EV71 vaccine administration.,['120 healthy infants aged 6-35\xa0months'],[],[],"[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],[],120.0,0.185979,Caution should be taken in using the EV71-IgM test for rapid EV71 infection diagnosis after EV71 vaccine administration.,"[{'ForeName': 'Shenyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention , Hangzhou, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Clinical Research Department, Sinovac Biotech Co., Ltd , Beijing, China.'}, {'ForeName': 'Xinpei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Shangyu District Center for Disease Control and Prevention , Shaoxing, China.'}, {'ForeName': 'Zhengkai', 'Initials': 'Z', 'LastName': 'Gan', 'Affiliation': 'Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention , Hangzhou, China.'}, {'ForeName': 'Jianqiang', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Shangyu District Center for Disease Control and Prevention , Shaoxing, China.'}, {'ForeName': 'Yingping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention , Hangzhou, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention , Hangzhou, China.'}, {'ForeName': 'Xiaosong', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention , Hangzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Clinical Research Department, Sinovac Biotech Co., Ltd , Beijing, China.'}, {'ForeName': 'Huakun', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Immunization Programme, Zhejiang Provincial Center for Disease Control and Prevention , Hangzhou, China.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1711678']
3436,31535922,"The Effect of the "" Great Village "" on Psychological Outcomes, Burden, and Mastery in African American Caregivers of Persons Living With Dementia.","The "" Great Village ,"" a cultural adaptation of a psychoeducation intervention the "" Savvy Caregiver "" for African American caregivers of persons living with dementia (PLwD), aims to develop caregivers' skills and improve the quality of the lives of both the PLwD and their caregivers. The goal of this study was to determine the effectiveness of the  Great Village  on depressive symptoms, anxiety, burden, and mastery in African American caregivers ( N  = 142). A three-arm randomized control trial ( Great Village, Great Village  + exercise, and attention control) was conducted over a period of 6 months. Caregivers who received either  Great Village or Great Village  + exercise reported significant reduction in depressive symptoms and improvement in mastery. Caregivers who received only  Great Village  reported a reduction in anxiety. Receiving no intervention worsened caregiver burden. African American caregivers should receive culturally tailored interventions to support their health and well-being and improve their competence in caregiving.",2020,Receiving no intervention worsened caregiver burden.,"['African American caregivers ( N  = 142', 'African American caregivers of persons living with dementia (PLwD', 'African American Caregivers of Persons Living With Dementia', 'African American caregivers']","[' Great Village ', 'psychoeducation intervention the "" Savvy Caregiver ', 'Great Village or Great Village  + exercise']","['Psychological Outcomes, Burden, and Mastery', 'caregiver burden', 'depressive symptoms and improvement in mastery', 'anxiety', 'depressive symptoms, anxiety, burden, and mastery']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0469766,Receiving no intervention worsened caregiver burden.,"[{'ForeName': 'Glenna S', 'Initials': 'GS', 'LastName': 'Brewster', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Fayron', 'Initials': 'F', 'LastName': 'Epps', 'Affiliation': 'Georgia State University, Atlanta, USA.'}, {'ForeName': 'Clinton E', 'Initials': 'CE', 'LastName': 'Dye', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hepburn', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Melinda K', 'Initials': 'MK', 'LastName': 'Higgins', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Parker', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464819874574']
3437,31782643,A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation,"Background


Patient-specific cutting blocks in total knee arthroplasty have been promoted to improve mechanical alignment, reduce alignment outliers and improve patient outcomes. The aim of this study was to compare the efficacy of patient-specific instrumentation (PSI) and conventional instrumentation (CI) in achieving neutral alignment and accurate component positioning in total knee arthroplasty.
Methods


We conducted a double-blinded randomized controlled trial in which patients were randomly assigned to treatment with either PSI or CI.
Results


Fifty-four patients were included in the study. No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91. Tibial slope was found to be more accurately reproduced to the preoperative target of 3° with PSI than with CI (3.8°± 3.1° v. 7.7°± 3.6°, respectively, p < 0.001). There were no differences found in patient-reported outcome measures, surgical time or length of hospital stay.
Conclusion


Given the added cost of the PSI technique, its use is difficult to justify given the small improvement in only a single alignment parameter.
Clinical trial registration


Clinicaltrials.gov, no. NCT03416946",2019,No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91.,"['total knee arthroplasty', 'Fifty-four patients were included in the study']","['PSI technique', 'patient-specific instrumentation (PSI) and conventional instrumentation (CI', 'PSI or CI', 'total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation']","['coronal alignment', 'Tibial slope', 'surgical time or length of hospital stay']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",54.0,0.524409,No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91.,"[{'ForeName': 'Thomas R.', 'Initials': 'TR', 'LastName': 'Turgeon', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Cameron', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'Colin D.', 'Initials': 'CD', 'LastName': 'Burnell', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'David R.', 'Initials': 'DR', 'LastName': 'Hedden', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}, {'ForeName': 'Eric R.', 'Initials': 'ER', 'LastName': 'Bohm', 'Affiliation': 'From the Department of Surgery, Section of Orthopaedics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); the Concordia Joint Replacement Group, Winnipeg, Man. (Turgeon, Burnell, Hedden, Bohm); and the Max Rady College of Medicine, University of Manitoba, Winnipeg, Man. (Cameron).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.018318']
3438,30816305,Distinct online and offline effects of alpha and beta transcranial alternating current stimulation (tACS) on continuous bimanual performance and task-set switching.,"In the present study we examined the effect of bihemispheric in-phase synchronization of motor cortical rhythms on complex bimanual coordination. Twenty young healthy volunteers received 10 Hz or 20 Hz tACS in a double-blind crossover design while performing a bimanual task-set switching paradigm. We used a bilateral high-density montage centred over the hand knob representation within the primary motor cortices to apply tACS time-locked to the switching events. Online tACS in either frequency led to faster but more erroneous switching transitions compared to trials without active stimulation. When comparing stimulation frequencies, 10 Hz stimulation resulted in higher error rates and slower switching transitions than 20 Hz stimulation. Furthermore, the stimulation frequencies showed distinct carry-over effects in trials following stimulation trains. Non-stimulated switching transitions were generally faster but continuous performance became more erroneous over time in the 20 Hz condition. We suggest that the behavioural effects of bifocal in-phase tACS are explained by online synchronization of long-range interhemispheric sensorimotor oscillations, which impacts on interhemispheric information flow and the top-down control required for flexible control of complex bimanual actions. Different stimulation frequencies may lead to distinct offline effects, which potentially accumulate over time and therefore need to be taken into account when evaluating subsequent performance.",2019,Online tACS in either frequency led to faster but more erroneous switching transitions compared to trials without active stimulation.,['Twenty young healthy volunteers'],"['bihemispheric', 'bilateral high-density montage centred over the hand knob representation', 'alpha and beta transcranial alternating current stimulation (tACS', '10\u2009Hz or 20\u2009Hz tACS']",['higher error rates and slower switching transitions'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}]",20.0,0.179821,Online tACS in either frequency led to faster but more erroneous switching transitions compared to trials without active stimulation.,"[{'ForeName': 'Kirstin-Friederike', 'Initials': 'KF', 'LastName': 'Heise', 'Affiliation': 'Research Center for Movement Control and Neuroplasticity, Department of Movement Sciences, KU Leuven, Leuven, Belgium. kirstin.heise@kuleuven.be.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Monteiro', 'Affiliation': 'Research Center for Movement Control and Neuroplasticity, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Leunissen', 'Affiliation': 'Research Center for Movement Control and Neuroplasticity, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Mantini', 'Affiliation': 'Research Center for Movement Control and Neuroplasticity, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Stephan P', 'Initials': 'SP', 'LastName': 'Swinnen', 'Affiliation': 'Research Center for Movement Control and Neuroplasticity, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]",Scientific reports,['10.1038/s41598-019-39900-0']
3439,31241192,A randomized controlled trial of a mobile application-assisted nurse-led model used to improve treatment outcomes in children with asthma.,"AIM


To evaluate the effectiveness of a mobile application-assisted nurse-led management model in childhood asthma.
BACKGROUND


Studies have shown that a nurse-led asthma management model can improve asthma outcomes. However, the role of a mobile application-assisted nurse-led model in paediatric asthma management has not been studied well.
DESIGN


A multi-centre randomized clinical trial.
METHODS


The trial was conducted between March 2017-March 2018. A total of 152 children (6 to 11.9 years old) were enrolled, with 77 children in the experimental group and 75 in the control group. All children received nurse-led asthma management and other routine treatment measures, including inhaled corticosteroids. Meanwhile, a mobile application was used to manage asthma only for children in the experimental group. Primary outcome was frequency of asthma exacerbations. All outcomes were evaluated twice a month for 12 months.
RESULTS


Compared with the pre-enrollment period, frequency of asthma exacerbations decreased in the post-enrollment period in the two groups, with a greater decrease in the experimental group. Compared with children in the control group, children in the experimental group had better secondary outcomes, such as improved adherence, higher Childhood Asthma Control Test scores, decreased respiratory tract infections, days of antibiotic use, days of school absence, parental work loss, and medical expenses.
CONCLUSION


A mobile application-assisted nurse-led management model decreased asthma exacerbations and improved secondary outcomes in children with asthma. Further research is needed to verify its validity in larger population samples.
IMPACT


Children with asthma benefited from a nurse-led asthma management model when combined with mobile application. This trial suggested that computer and Internet technologies should be incorporated into nurse-led asthma strategy in paediatric asthma management.
TRIAL REGISTRATION


The current trial was registered online with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016726).",2019,"Compared with the pre-enrollment period, frequency of asthma exacerbations decreased in the post-enrollment period in the two groups, with a greater decrease in the experimental group.","['152 children (6 to 11.9 years old) were enrolled, with 77 children in the experimental group and 75 in the control group', 'children with asthma']","['mobile application-assisted nurse-led model', 'inhaled corticosteroids', 'mobile application-assisted nurse-led management model']","['improved adherence, higher Childhood Asthma Control Test scores, decreased respiratory tract infections, days of antibiotic use, days of school absence and parental work loss and medical expenses', 'frequency of asthma exacerbations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma (disorder)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",152.0,0.131622,"Compared with the pre-enrollment period, frequency of asthma exacerbations decreased in the post-enrollment period in the two groups, with a greater decrease in the experimental group.","[{'ForeName': 'Shaoxia', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Nursing Department, Jiangnan Community Healthcare Center, Jinhua, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Pediatrics Department, Xiguan Community Healthcare Center, Jinhua, China.'}, {'ForeName': 'Zhijiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Pediatrics Department, Tianxiang East Hospital, Yiwu, China.'}, {'ForeName': 'Wenfen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Pediatrics Department, Yiwu Chouzhou Hospital, Yiwu, China.'}, {'ForeName': 'Yajuan', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Pediatrics Department, Xiguan Community Healthcare Center, Jinhua, China.'}, {'ForeName': 'Weihan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Scientific Research Management and Medical Education, Jinhua Municipal Traditional Chinese Medicine Hospital, Zhejiang Chinese Medical University, Jinhua, China.'}, {'ForeName': 'Yuehua', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'General Medicine Department, Jinhua Municipal Central Hospital, Jinhua, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Pediatrics Department, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.""}, {'ForeName': 'Xubo', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Pediatrics Department, Xiguan Community Healthcare Center, Jinhua, China.'}]",Journal of advanced nursing,['10.1111/jan.14143']
3440,31330198,The impact of resuscitation guideline terminology on quality of dispatcher-assisted cardiopulmonary resuscitation: A randomised controlled manikin study.,"BACKGROUND


Cardiopulmonary resuscitation (CPR) guidelines vary in the terminology used to describe target chest compression depth, which may impact CPR quality. We investigated the impact of using different chest compression depth instruction terminologies on CPR quality.
METHODS


We conducted a parallel group, three-arm, randomised controlled manikin trial in which individuals without recent CPR training were instructed to deliver compression-only CPR for 2-min based on a standardised dispatcher-assisted CPR script. Participants were randomised in a 1:1:1 ratio to receive CPR delivery instructions that instructed them to deliver chest compressions based on the following terminologies: 'press at least 5 cm', 'press approximately 5 cm' or 'press hard and fast.' The primary outcome was compression depth, measured in millimetres.
RESULTS


Between October 2017 and June 2018, 330 participants were randomised to 'at least 5 cm' (n = 109), 'approximately 5 cm' (n = 110) and 'hard and fast' (n = 111), in which mean chest compression depth was 40.9 mm (SD 13.8), 35.4 mm (SD 14.1), and 46.8 mm (SD 15.0) respectively. Mean difference in chest compression depth between 'at least 5 cm' and 'approximately 5 cm' was 5.45 (95% confidence interval (95% CI) 0.78-10.12), between 'hard and fast' and 'approximately 5 cm' was 11.32 (95% CI 6.65-15.99), and between 'hard and fast' and 'at least 5 cm' was 5.87 (95% CI 1.21-10.53). Chest compression rate and count were both highest in the 'hard and fast' group.
CONCLUSIONS


The use of 'hard and fast' terminology was superior to both 'at least 5 cm' and 'approximately 5 cm' terminologies.
TRIAL REGISTRATION


ISRCTN15128211.",2019,Mean difference in chest compression depth between 'at least 5 cm' and 'approximately 5 cm' was 5.45,"['individuals without recent CPR training', '330 participants', 'Between October 2017 and June 2018']","['resuscitation guideline terminology', 'dispatcher-assisted cardiopulmonary resuscitation', ""CPR delivery instructions that instructed them to deliver chest compressions based on the following terminologies: 'press at least 5\u202fcm', 'press approximately 5\u202fcm' or 'press hard and fast"", 'compression-only CPR for 2-min based on a standardised dispatcher-assisted CPR script']","['chest compression depth', 'mean chest compression depth', 'compression depth, measured in millimetres', 'Chest compression rate and count']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439200', 'cui_str': 'mm'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",330.0,0.25215,Mean difference in chest compression depth between 'at least 5 cm' and 'approximately 5 cm' was 5.45,"[{'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Trethewey', 'Affiliation': 'Critical Care Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Hrushikesh', 'Initials': 'H', 'LastName': 'Vyas', 'Affiliation': 'Critical Care Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'Critical Care Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Critical Care Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Melody', 'Affiliation': 'Critical Care Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Critical Care Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Critical Care Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK. Electronic address: k.couper@warwick.ac.uk.'}]",Resuscitation,['10.1016/j.resuscitation.2019.07.016']
3441,31152308,Effect of corticosteroids on myocardial injury among patients hospitalized for community-acquired pneumonia: rationale and study design. The colosseum trial.,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers the incidence of MI during the hospital stay. No data exist so far on the effect of corticosteroids on myocardial injury in CAP patients. The primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin (hs-cTnT), in a cohort of patients hospitalized for CAP. Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization, at 30 days from hospital admission and during 2 years' follow-up. The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation. Double-blind randomized placebo-controlled trial. One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone (20 mg b.i.d) or placebo from hospital admission. Serum hs-cTnT will be measured at admission and every day until up 3 days from admission. ECG will be monitored every day until discharge. After discharge, all patients will be followed-up 2 years. This is the first clinical trial aimed at examining whether methylprednisolone treatment may reduce myocardial injury. The results of this trial may constitute the basis for conducting a larger multicenter trial aimed to evaluate the effect of corticosteroid on cardiovascular events in this setting.",2020,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI).","['patients hospitalized for CAP', 'One hundred twenty-two eligible patients', 'CAP patients', 'patients hospitalized for community-acquired pneumonia']","['corticosteroid', 'placebo', 'methylprednisolone', 'corticosteroids']","['cardiovascular events', 'myocardial injury', 'incidence of MI during the hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",122.0,0.547563,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Violi', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. francesco.violi@uniroma1.it.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Calvieri', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrologic and Geriatric Sciences, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cangemi', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}]",Internal and emergency medicine,['10.1007/s11739-019-02117-0']
3442,31929124,Management of abdominal distension in the preterm infant with noninvasive ventilation: Comparison of cenit versus 2x1 technique for the utilization of feeding tube.,"BACKGROUND


Preterm infants are fed by orogastric / nasogastric tube until they reach maturation and coordination of sucking, swallowing and respiration at approximately 32-34 weeks of corrected age. While being on non-invasive ventilation (NIV), they frequently present abdominal distension. Currently at our institution two techniques are used for the management of abdominal distension in preterm infants fed by bolus via orogastric tube: cenit and 2 x 1.The aim of this study was to compare the proportion of preterm infants presenting NIV-associated abdominal distension with each of these techniques.
STUDY DESIGN


We conducted a randomized clinical trial including infants of <  36.6 weeks of gestation and <  1500 g of birth weight who were admitted to our NICU during the period of April 1, 2016 to April 1, 2018 and received NIV. The presence of abdominal distension >  2 cm was the primary outcome. Secondary outcomes were presence of reflux, regurgitation, oxygen saturation during feeding and days to reach full feedings. Feeding tube drainage, stool characteristics and the use of prokinetics were confounding variables.
RESULTS


A total of 97 patients were included. Forty-six in the cenit group and 51 in the 2 x 1 group. There was no difference in the proportion of infants with abdominal distension >  2 cm between groups. Oxygen saturation during feeding at volume of 150 ml/kg/day was higher in the cenit group with statistical significance.
CONCLUSION


The use of cenit or 2 x 1 technique in preterm infants with NIV did not improve abdominal distension or other indicators of feeding tolerance.",2020,"Oxygen saturation during feeding at volume of 150 ml/kg/day was higher in the cenit group with statistical significance.
","['A total of 97 patients were included', 'preterm infants with NIV', 'Preterm infants', 'preterm infants fed by bolus via orogastric tube: cenit and 2', 'preterm infants presenting NIV-associated abdominal distension with each of these techniques', 'preterm infant with noninvasive ventilation', 'infants of\u200a< \u200a36.6 weeks of gestation and\u200a< \u200a1500\u200ag of birth weight who were admitted to our NICU during the period of April 1, 2016 to April 1, 2018 and received NIV']",[],"['abdominal distension', 'presence of reflux, regurgitation, oxygen saturation during feeding and days to reach full feedings', 'proportion of infants with abdominal distension', 'Oxygen saturation']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0442472', 'cui_str': 'Via orogastric tube (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",97.0,0.0861393,"Oxygen saturation during feeding at volume of 150 ml/kg/day was higher in the cenit group with statistical significance.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cordero González', 'Affiliation': ''}, {'ForeName': 'N O', 'Initials': 'NO', 'LastName': 'Valdés Vázquez', 'Affiliation': ''}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Izaguirre Alcántara', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Michel Macías', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carrera Muiños', 'Affiliation': ''}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Morales Barquet', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Fernández Carrocera', 'Affiliation': ''}]",Journal of neonatal-perinatal medicine,['10.3233/NPM-190301']
3443,31734121,Effect of Protein Supplementation on Physical Performance in Older People With Sarcopenia-A Randomized Controlled Trial.,"OBJECTIVES


To test the long-term effects of whey-enriched protein supplementation on muscle and physical performance.
DESIGN


A 12-month randomized controlled double blind trial with a 43-month of post-trial follow-up.
SETTING


Porvoo, Finland.
PARTICIPANTS


A total of 218 older (>74 years of age) community-dwelling people with sarcopenia.
INTERVENTION


(1) Control with no supplementation; (2) isocaloric placebo; and (3) 20 g × 2 whey-enriched protein supplementation. All participants were given instructions on home-based exercise, dietary protein, and vitamin D supplementation of 20 μg/d.
MEASUREMENTS


Physical performance was assessed by short physical performance battery and continuous summary physical performance scores. Hand grip strength and calf intracellular resistance based skeletal muscle index were measured by bioimpedance spectroscopy. The measurements were performed at 0, 6, and 12 months. The post-trial follow-up was performed by a postal questionnaire and national census record data.
RESULTS


The participants were older (75-96 years of age) and mostly women (68%). The test supplements had no significant effects on physical performance; the 12-month changes for short physical performance battery were -0.55, -.05, and 0.03 points in control, isocaloric, and protein groups (P = .17), respectively. The changes in continuous summary physical performance scores were similar between the intervention groups (P = .76). The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups. One-half of the patients (56%) in both supplement groups reported mild gastrointestinal adverse effects. Differences were found neither in the all-cause mortality nor physical functioning in the post-trial follow-up.
CONCLUSIONS


The whey-enriched protein supplementation in combination with low intensity home-based physical exercise did not attenuate the deterioration of muscle and physical performance in community-dwelling older people with sarcopenia.",2020,"The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups.","['Older People With Sarcopenia', 'A total of 218 older (>74\xa0years of age) community-dwelling people with sarcopenia', 'participants were older (75-96\xa0years of age) and mostly women (68', 'community-dwelling older people with sarcopenia', 'Porvoo, Finland']","['1) Control with no supplementation; (2) isocaloric placebo; and (3) 20\xa0g\xa0×\xa02 whey-enriched protein supplementation', 'whey-enriched protein supplementation', 'instructions on home-based exercise, dietary protein, and vitamin D supplementation of 20\xa0μg/d', 'whey-enriched protein supplementation in combination with low intensity home-based physical exercise', 'Protein Supplementation']","['Physical Performance', 'short physical performance battery', 'hand grip strength', 'short physical performance battery and continuous summary physical performance scores', 'calf intracellular resistance-based skeletal muscle index', 'mild gastrointestinal adverse effects', 'muscle and physical performance', 'physical performance', 'Physical performance', 'continuous summary physical performance scores', 'deterioration of muscle and physical performance', 'Hand grip strength and calf intracellular resistance based skeletal muscle index']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0452720', 'cui_str': 'Whey'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C2607857'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",218.0,0.0864948,"The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups.","[{'ForeName': 'Mikko P', 'Initials': 'MP', 'LastName': 'Björkman', 'Affiliation': 'Geriatric Unit, Department of Internal Medicine, University of Helsinki, Helsinki, Finland. Electronic address: bjorkmik@gmail.com.'}, {'ForeName': 'Merja H', 'Initials': 'MH', 'LastName': 'Suominen', 'Affiliation': 'Unit of General Practice, Helsinki University Central Hospital, and University of Helsinki, Helsinki, Finland; Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Unit of General Practice, Helsinki University Central Hospital, and University of Helsinki, Helsinki, Finland; Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Satu K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Harriet U', 'Initials': 'HU', 'LastName': 'Finne-Soveri', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Timo E', 'Initials': 'TE', 'LastName': 'Strandberg', 'Affiliation': 'Geriatric Unit, Department of Internal Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kaisu H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Unit of General Practice, Helsinki University Central Hospital, and University of Helsinki, Helsinki, Finland; Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Reijo S', 'Initials': 'RS', 'LastName': 'Tilvis', 'Affiliation': 'Geriatric Unit, Department of Internal Medicine, University of Helsinki, Helsinki, Finland.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.09.006']
3444,30232744,"Effects of Probiotic Yogurt on Serum Omentin-1, Adropin, and Nesfatin-1 Concentrations in Overweight and Obese Participants Under Low-Calorie Diet.","Data on the effects of probiotics on adipokines such as omentin-1, nesfatin-1, and adropin are limited. The aim of this study was to evaluate the effects of probiotic yogurt along with a low-calorie diet (LCD) on serum omentin-1, adropin, and nesfatin-1 concentrations in obese and overweight individuals. Sixty obese or overweight individuals aged 20-50 years old were involved in this randomized double-blind placebo-controlled clinical trial. Participants were randomly allocated into two groups to consume either probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium BB12, and Lactobacillus casei DN001 (10 8  CFU/g each) (n = 30) or regular yogurt (n = 30) along with a LCD in both groups for 8 weeks. Fasting blood samples were taken at baseline and after the 8-week intervention to determine related variables. A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002). After the 8-week intervention, a significant difference in serum adropin concentration (6.04 ± 24.46 vs - 8.16 ± 24.66 pg/ml, P = 0.03 and serum omentin-1 concentration (0.09 ± 1.51 vs - 1.5 ± 1.8 ng/ml, P = 0.003) was observed between two groups. We did not observe any significant changes in nesfatin-1 and other anthropometric measures. Overall, probiotic yogurt for 8 weeks among overweight or obese individuals along with LCD had beneficial effects on body fat percentage, serum omentin-1, and adropin concentration, but it did not have any effect on nesfatin-1 level.",2019,"A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002).","['Sixty obese or overweight individuals aged 20-50\xa0years old', 'obese and overweight individuals', 'Overweight and Obese Participants Under Low-Calorie Diet']","['Probiotic Yogurt', 'probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium BB12, and Lactobacillus casei DN001', 'low-calorie diet (LCD', 'placebo']","['body fat percentage, serum omentin-1, and adropin concentration', 'serum adropin concentration', 'serum omentin-1, adropin, and nesfatin-1 concentrations', 'Fasting blood samples', 'serum omentin-1 concentration', 'Serum Omentin-1, Adropin, and Nesfatin-1 Concentrations', 'body fat percentage']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}]","[{'cui': 'C3853203', 'cui_str': 'Probiotic yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0535447,"A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002).","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Raji Lahiji', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Eisa', 'Initials': 'E', 'LastName': 'Salehi', 'Affiliation': 'Immunology Department, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Yazdani', 'Affiliation': 'Department of Microbiology, School of Biology Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Raheleh', 'Initials': 'R', 'LastName': 'Shokouhi Shoormasti', 'Affiliation': 'Immunology, Asthma and Allergy Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. farzadshidfar@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9470-3']
3445,30757926,Comparison of immediate effects of sling-based manual therapy on specific spine levels in subjects with neck pain and forward head posture: a randomized clinical trial.,"Purpose:  Forward head posture is identified as the flexion of the lower cervical spine along with the extension of the upper cervical spine, with an overall increase in the cervical curve. This study aimed to compare the immediate effect of upper-cervical level and cervicothoracic junction level manual therapy on head posture, cervical range of motion and muscle activity of the subjects with forward head posture. Methods:  A total 22 subjects with chronic neck pain (numeric pain rating scale >3, forward head posture: cranio-vertebral angle <51°) participated in the study and were randomly allocated into the upper-cervical ( n  = 11) and cervicothoracic junction ( n  = 11) groups. Cranio-vertebral angle, cervical range of motion, and electromyography amplitude during performance of the craniocervical flexion test were measured before and immediately after the intervention. Results/findings:  There were no significant main effects for the group by time outcome score of craniovertebral angle and electromyography amplitude. However, in the range of motion of the cervical area, the cervicothoracic junction group showed a significant increase in extension and right rotation than the upper-cervical group ( p  < 0.05). Moreover, in both groups, the electromyography amplitude of the sternocleidomastoid muscle was significantly reduced after intervention. The electromyography amplitude of the anterior scalene muscle in only the cervicothoracic junction group was significantly reduced after intervention ( p  < 0.05). Conclusion:  Cervicothoracic junction manual therapy improved cervical alignment, cervical mobility (extension, rotation), and muscle recruitment ability in subjects with forward head posture. These observations may partially explain the efficacy of this manual therapy in rehabilitation of individuals with mechanical neck disorder (with forward head posture).Implications for rehabilitationForward head posture is identified as the flexion of the lower cervical spine along with the extension of the upper cervical spine, with an overall increase in the cervical curve.Cervicothoracic area manual therapy in subjects with neck pain and forward head posture better improved the muscle recruitment ability than upper cervical area manual therapy during motor tasks.",2020,There were no significant main effects for the group by time outcome score of craniovertebral angle and electromyography amplitude.,"['subjects with neck pain', 'subjects with neck pain and forward head posture', 'individuals with mechanical neck disorder (with forward head posture', 'subjects with forward head posture', 'A total 22 subjects with chronic neck pain (numeric pain rating scale >3, forward head posture: cranio-vertebral angle <51°) participated in the study']","['upper-cervical level and cervicothoracic junction level manual therapy', 'Cervicothoracic area manual therapy', 'cervicothoracic junction', 'Cervicothoracic junction manual therapy', 'sling-based manual therapy']","['Cranio-vertebral angle, cervical range of motion, and electromyography amplitude during performance of the craniocervical flexion test', 'electromyography amplitude of the sternocleidomastoid muscle', 'electromyography amplitude of the anterior scalene muscle', 'head posture, cervical range of motion and muscle activity', 'cervical alignment, cervical mobility (extension, rotation), and muscle recruitment ability', 'specific spine levels', 'time outcome score of craniovertebral angle and electromyography amplitude', 'extension and right rotation']","[{'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0450195', 'cui_str': 'Cervicothoracic (qualifier value)'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]",22.0,0.0299766,There were no significant main effects for the group by time outcome score of craniovertebral angle and electromyography amplitude.,"[{'ForeName': 'Dae-Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Chonbuk National University Hospital, Republic of Korea.'}, {'ForeName': 'Suhn-Yeop', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea.'}]",Disability and rehabilitation,['10.1080/09638288.2019.1571638']
3446,30851010,Feasibility of parent communication training with remote coaching using smartphone apps.,"BACKGROUND


Communication training for parents of young children with neurodisability is often delivered in groups and includes video coaching. Group teaching is problematic when there is wide variation in the characteristics and needs amongst participants.
AIMS


To assess the potential feasibility and acceptability of delivering one-to-one parent training supported by remote coaching using smartphone apps and of conducting further trials of the intervention.
METHODS & PROCEDURES


We aimed to recruit eight children aged 12-48 months with motor disorders and communication difficulties and to provide families with individual parent training in six weekly home visits supplemented by remote coaching via smartphone apps. For outcome measurement, parents recorded their interaction with their child thrice weekly during baseline (3 weeks), intervention, post-intervention (3 weeks) and follow-up (1 week). Measures comprised parent responsiveness and counts of children's communication and vocalization. Research design feasibility was measured through rates of recruitment, attrition, outcome measure completion and agreement between raters on outcome measurement. Intervention feasibility was assessed through the proportion of therapy sessions received, the number of videos and text messages shared using the apps in remote coaching, and message content. Parents were interviewed about the acceptability of the intervention and trial design. Interviews were transcribed and analyzed using inductive thematic analysis.
OUTCOMES & RESULTS


Nine children were recruited over 16 weeks. All fitted the inclusion criteria. Four families withdrew from the study. Five families completed the intervention. No family submitted the target number of video recordings for outcome measurement. Interrater agreement was moderate for child communication (K = 0.46) and vocalization (K = 0.60) and high for The Responsive Augmentative and Alternative Communication Style scale (RAACS) (r s  = 0.96). Parents who completed the intervention reported positive experiences of the programme and remote coaching via the apps. Therapist messages via the app contained comments on parent and child behaviour and requests for parental reflection/action; parental messages contained reflections on children's communication.
CONCLUSIONS & IMPLICATIONS


The intervention and study design demanded high levels of parental involvement and was not suitable for all families. Recording shorter periods of interaction via mobile phones or using alternative methods of data collection may increase feasibility of outcome measurement.",2019,"Intervention feasibility was assessed through the proportion of therapy sessions received, the number of videos and text messages shared using the apps in remote coaching, and message content.","['eight children aged 12-48 months with motor disorders and communication difficulties and to provide families with individual parent training in six weekly home visits supplemented by remote coaching via smartphone apps', 'parents of young children with neurodisability', 'Nine children were recruited over 16 weeks']","['parent communication training', 'Communication training']","[""parent responsiveness and counts of children's communication and vocalization"", 'Responsive Augmentative and Alternative Communication Style scale (RAACS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0221163', 'cui_str': 'Motor Disorders'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4302653', 'cui_str': 'Neurodisability'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0564182', 'cui_str': 'Vocalizing'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0222045'}]",9.0,0.0525825,"Intervention feasibility was assessed through the proportion of therapy sessions received, the number of videos and text messages shared using the apps in remote coaching, and message content.","[{'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Stockwell', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ebtisam', 'Initials': 'E', 'LastName': 'Alabdulqader', 'Affiliation': 'Open Lab, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Open Lab, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Olivier', 'Affiliation': 'Open Lab, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pennington', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}]",International journal of language & communication disorders,['10.1111/1460-6984.12468']
3447,30876859,Environmental enrichment and amantadine confer individual but nonadditive enhancements in motor and spatial learning after controlled cortical impact injury.,"Environmental enrichment (EE) and amantadine (AMT) enhance motor and cognitive outcome after experimental traumatic brain injury (TBI). However, there are no data on the effects of combining these two therapies. Hence, the aim of the current study was to combine EE and AMT after TBI to determine if their net effect further enhances motor and cognitive performance. Anesthetized adult male rats received either a cortical impact of moderate severity or sham injury and then were randomly assigned to EE or standard (STD) housing and once daily administration of AMT (20 mg/kg; i.p.) or saline vehicle (VEH, 1 mL/kg; i.p.) beginning 24 h after injury for 19 days. Motor and cognitive function were assessed on post-surgical days 1-5 and 14-19, respectively. Cortical lesion volume was quantified on day 21. There were no statistical differences among the sham groups regardless of therapy, so the data were pooled. EE, AMT, and their combination (EE + AMT) improved beam-balance, but only EE and EE + AMT enhanced beam-walking. All three treatment paradigms improved spatial learning and memory relative to the VEH-treated STD controls (p < 0.05). No differences were revealed between the EE groups, regardless of treatment, but both were better than the AMT-treated STD group on beam-walking and spatial learning (p < 0.05). Both EE groups equally reduced cortical lesion volume relative to the STD-housed AMT and VEH groups (p < 0.05). The results indicate that although beneficial on their own, EE + AMT do not provide additional benefits after TBI. It is important to note that the lack of additive effects using the current treatment and behavioral protocols does not detract from the benefits of each individual therapy. The findings provide insight for future combination studies.",2019,"No differences were revealed between the EE groups, regardless of treatment, but both were better than the AMT-treated STD group on beam-walking and spatial learning (p < 0.05).","['Anesthetized adult male rats', 'experimental traumatic brain injury (TBI']","['cortical impact of moderate severity or sham injury and then were randomly assigned to EE or standard (STD) housing and once daily administration of AMT', 'amantadine', 'saline vehicle (VEH', 'Environmental enrichment (EE) and amantadine (AMT']","['Motor and cognitive function', 'Cortical lesion volume', 'spatial learning and memory relative', 'cortical lesion volume']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0582587', 'cui_str': 'Spatial Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0451861,"No differences were revealed between the EE groups, regardless of treatment, but both were better than the AMT-treated STD group on beam-walking and spatial learning (p < 0.05).","[{'ForeName': 'Isabel H', 'Initials': 'IH', 'LastName': 'Bleimeister', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Tracey R', 'Initials': 'TR', 'LastName': 'Lam', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Derrick M', 'Initials': 'DM', 'LastName': 'Brooks', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Cheng', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Corina O', 'Initials': 'CO', 'LastName': 'Bondi', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States; Neurobiology, University of Pittsburgh, Pittsburgh, PA 15213, United States; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Kline', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA 15213, United States; Center for the Neural Basis of Cognition, University of Pittsburgh, Pittsburgh, PA 15213, United States; Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA 15213, United States; University of Pittsburgh, Pittsburgh, PA 15213, United States. Electronic address: klineae@upmc.edu.'}]",Brain research,['10.1016/j.brainres.2019.03.007']
3448,31187454,"Long-Term Neuropsychological Outcomes from an Open-Label Phase I/IIa Trial of 2-Hydroxypropyl-β-Cyclodextrins (VTS-270) in Niemann-Pick Disease, Type C1.","BACKGROUND


Niemann-Pick disease, type C1 (NPC1) is a neurodegenerative condition that arises from mutations of NPC1 and is often diagnosed in children. Recently, several drug trials have been implemented to minimize neurodegeneration, including a trial of 2-hydroxypropyl-β-cyclodextrins (VTS-270).
OBJECTIVES


The current study extends findings from a previous report of 18 months of disease severity data by describing neuropsychological outcomes over the course of 36 months post-baseline.
DESIGN


An open-label, dose-escalation phase I/IIa study of VTS-270 was performed in participants with NPC1 aged 4-23 years.
METHODS


Fourteen participants were sequentially assigned to receive monthly initial intrathecal VTS-270 at doses of 50, 200, 300, or 400 mg per month. After initial dosing, participants were dose-escalated (to 600 or 1200 mg) as tolerated. Participants were evaluated at 6-month intervals using a standardized neuropsychological battery, including tests of cognition and adaptive behavior. A random effects model with restricted maximum likelihood estimation was constructed for each outcome, and the slope was the parameter of interest.
RESULTS


Findings based on IQ scores and both standard scores and age equivalents of adaptive functioning indicate that there were not meaningful declines in these areas during the study period. The average annualized change in Full Scale IQ was negative: B = - 1.28, standard error (SE) = 0.70, t(34.2) = - 1.83, p = 0.076. The Vineland-II Adaptive Behavior Composite standard score decreased by 1.76 points per year [SE = 0.67, t(59.1) = - 2.62, p = 0.011], but annualized slopes for each of the domain age equivalents were positive: Communication [B = 0.71, SE = 3.12, t(60.7) = 0.23, p = 0.82], Socialization [B = 2.99, SE = 2.92, t(60.4) = 1.03, p = 0.30], Daily Living Skills [B = 2.76, SE = 2.76, t(60.3) = 1.18, p = 0.24], and Motor Skills [B = 1.42, SE = 0.94, t(50.5) = 1.51, p = 0.14], indicating not worsening but slower-than-average acquisition of skills.
CONCLUSION


In conjunction with previous findings, these results provide support for the slowing of disease progress up to 36 months post-initiation of intrathecal VTS-270.
REGISTRATION


ClinicalTrials.gov identifier NCT01747135: Hydroxypropyl Beta Cyclodextrin for Niemann-Pick type C1 Disease.",2019,"The Vineland-II Adaptive Behavior Composite standard score decreased by 1.76 points per year [SE = 0.67, t(59.1) = - 2.62, p = 0.011], but annualized slopes for each of the domain age equivalents were positive: Communication [B = 0.71, SE = 3.12, t(60.7) = 0.23,","['participants with NPC1 aged 4-23\xa0years', 'Niemann-Pick type C1 Disease', 'Fourteen participants']","['VTS-270', '2-Hydroxypropyl-β-Cyclodextrins (VTS-270', 'initial intrathecal VTS-270', 'Hydroxypropyl Beta Cyclodextrin']","['tolerated', 'Motor Skills', 'Vineland-II Adaptive Behavior Composite standard score', 'Full Scale IQ', 'Daily Living Skills']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0046237', 'cui_str': 'hydroxypropyl betadex'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",14.0,0.0744824,"The Vineland-II Adaptive Behavior Composite standard score decreased by 1.76 points per year [SE = 0.67, t(59.1) = - 2.62, p = 0.011], but annualized slopes for each of the domain age equivalents were positive: Communication [B = 0.71, SE = 3.12, t(60.7) = 0.23,","[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Thurm', 'Affiliation': 'Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Farhat', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bianconi', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Lee Ann', 'Initials': 'LA', 'LastName': 'Keener', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Forbes D', 'Initials': 'FD', 'LastName': 'Porter', 'Affiliation': 'Division of Translational Research, Eunice Kennedy Shriver National Institute of Child Health and Development, National Institutes of Health, 10 Center Drive, Bethesda, MD, 20892, USA. fdporter@mail.nih.gov.'}]",CNS drugs,['10.1007/s40263-019-00642-2']
3449,32191001,[Efficiency assessment of low intensity-shokwave therapy in the treatment of chronic pelvic pain syndrome].,"OBJECTIVE


the aim of this study was to evaluate the effect of extracorporeal shockwave therapy on CPPS due to non bacterial prostatitis.
METHOD


s: There were two groups in the study. 78 patients in the first group received 6 sessions of Low intensity-shokwave therapy (Li-ESWT) in three weeks. 40 patients from group ""2"" were receiving diclofenac sodium in the form of suppositories.
RESULTS


Patients in the first group showed significant improvement of pain and quality of life in comparison to the control group, which experienced less significant improvements.
CONCLUSION


Low intensity-shokwave therapy (Li-ESWT) is effective in chronic pelvic pain syndrome treatment.",2020,"RESULTS


Patients in the first group showed significant improvement of pain and quality of life in comparison to the control group, which experienced less significant improvements.
","['s', 'chronic pelvic pain syndrome', 'chronic pelvic pain syndrome treatment', '40 patients from group ""2"" were receiving', '78 patients in the first group received']","['diclofenac sodium', '6 sessions of Low intensity-shokwave therapy (Li-ESWT', 'low intensity-shokwave therapy', 'extracorporeal shockwave therapy', 'Low intensity-shokwave therapy (Li-ESWT']",['pain and quality of life'],"[{'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}]",78.0,0.013424,"RESULTS


Patients in the first group showed significant improvement of pain and quality of life in comparison to the control group, which experienced less significant improvements.
","[{'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Dariy', 'Affiliation': 'European Medical Center, Moscow, Russia.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Tirsy', 'Affiliation': 'European Medical Center, Moscow, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Grigoriev', 'Affiliation': 'European Medical Center, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
3450,32122727,Comparative evaluation of Low Level Laser Therapy and cryotherapy in pain control and wound healing following orthodontic tooth extraction: A double blind study.,"PURPOSE


To compare and evaluate pain and healing following orthodontic tooth extraction using Low Level Laser Therapy [LLLT] and Cryotherapy.
MATERIALS AND METHODS


62 patients referred for orthodontic extraction of bilateral bicuspids were included. Subjects were alternatively divided into two groups with 31 patients each. One of the bilateral extraction sites was subjected to either intervention, LLLT or Cryotherapy, while the other site was kept as control. Pain was assessed for 7 consecutive days by Visual Analogue Scale and Wound healing on 4 th , 7 th  and 14 th  days using a modified wound healing scale.
RESULTS


Pain scores were generally better for Group I [LLLT] when compared to Group II [Cryotherapy] on all days. The highest mean score for pain observed on the 1 st  post-extraction day was 4.00 ± 0.93 and 4.16 ± 0.93 for Group I and Group II respectively [p = 0.42]. It was also observed that LLLT helped in better wound healing as compared to cryotherapy with a significant difference in wound healing on 7 th  [mean score for Group I and Group II- 1.16 ± 0.52 and 1.6 ± 0.62 respectively: p = 0.01] and 14 th  [mean score Group I and Group II- 0.23 ± 0.43 and 1.0 ± 0.58 respectively: p = 0.00] post-extraction days.
CONCLUSION


LLLT has better analgesic and wound healing properties as compared to Cryotherapy, suggesting that LLLT should be preferred over cryotherapy whenever possible.",2020,"RESULTS


Pain scores were generally better for Group I [LLLT] when compared to Group II [Cryotherapy] on all days.","['orthodontic tooth extraction', '62 patients referred for orthodontic extraction of bilateral bicuspids were included']","['Low Level Laser Therapy [LLLT', 'LLLT or Cryotherapy', 'LLLT', 'Low Level Laser Therapy and cryotherapy']","['pain and healing', 'wound healing', 'highest mean score for pain', 'Pain scores', 'Pain', 'pain control and wound healing', 'Visual Analogue Scale and Wound healing']","[{'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0005373', 'cui_str': 'Bicuspid (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",62.0,0.0185722,"RESULTS


Pain scores were generally better for Group I [LLLT] when compared to Group II [Cryotherapy] on all days.","[{'ForeName': 'Sucratha Susie', 'Initials': 'SS', 'LastName': 'John', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: johnsucratha@gmail.com.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: drsm28@gmail.com.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: zainabgauri@yahoo.co.in.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: spankaj_in@yahoo.com.'}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Kumari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: dr.sarojsheoran@gmail.com.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: anjaliverma1027@gmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.01.012']
3451,31742465,Retroprosthetic Seroma After Laparoscopic Ventral Hernia Repair Is Related to Mesh Used?,"Purpose:  Retroprosthetic seroma (RS) is defined as a fluid collection located between the abdominal viscera and the intraperitoneal mesh implanted during surgery. Aim of this study is to report the incidence and clinical impact of RS based on the type of mesh implanted during laparoscopic ventral hernia repair (LVHR).  Materials and Methods:  Patients who underwent LVHR were allocated in group A if expanded polytetrafluoroethylene (ePTFE) mesh was used during surgery and in group B if other types of mesh were used. Patients were evaluated on postoperative day (POD) 1 and 7 with physical examination and 1 month after surgery by physical examination and with an abdominal computed tomography scan, respectively.  Results:  Sixty patients were included. Of these 41 patients (68.3%) were included in group A and 19 patients (31.7%) in group B. Signs of RS were not observed in any patient on POD 7. One month after surgery, RS was observed in 13 patients (21.6%). One patient (7.7%) with RS experienced great discomfort and mesh detachment, and underwent a second surgical treatment. All RSs were observed in group A, and the difference with group B was statistically significant ( P  = .005).  Conclusions:  The use of ePTFE mesh is related to the development of RS. The treatment of choice without clinical symptoms should be conservative. Randomized control trial and prospective studies with a larger sample size and control group are required to confirm these data, although this study shows a high evidence of the relation of RS and the type of mesh.",2020,"All RSs were observed in group A, and the difference with group B was statistically significant ( P  = .005).  ","['Patients who underwent LVHR', 'Sixty patients were included']","['expanded polytetrafluoroethylene (ePTFE) mesh', 'laparoscopic ventral hernia repair (LVHR']","['Retroprosthetic Seroma', 'great discomfort and mesh detachment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia (procedure)'}]","[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0541879', 'cui_str': 'Detachment'}]",60.0,0.0379515,"All RSs were observed in group A, and the difference with group B was statistically significant ( P  = .005).  ","[{'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Morales-Conde', 'Affiliation': 'Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, University Hospital ""Virgen del Rocio,"" University of Sevilla, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Gómez-Menchero', 'Affiliation': 'Unit of General and Digestive Surgery, Hospital Quirónsalud Sagrado Corazón, Sevilla, Spain.'}, {'ForeName': 'Isaias', 'Initials': 'I', 'LastName': 'Alarcón', 'Affiliation': 'Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, University Hospital ""Virgen del Rocio,"" University of Sevilla, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Balla', 'Affiliation': 'Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, University Hospital ""Virgen del Rocio,"" University of Sevilla, Spain.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2019.0646']
3452,31342886,Predicting potential to benefit from an iron intervention: a randomized controlled trial of double-fortified salt in female Indian tea pluckers.,"OBJECTIVE


The present study examines characteristics of those who benefited from a dietary Fe intervention comprised of salt double-fortified with iodine and Fe (DFS).
DESIGN


Data from a randomized controlled trial were analysed to identify predictors of improved Fe status and resolution of Fe deficiency (serum ferritin (sFt) < 12 μg/l) and low body Fe (body Fe (BI) < 0·0 mg/kg) using non-parametric estimations and binomial regression models.
SETTING


A tea estate in West Bengal, India.
PARTICIPANTS


Female tea pluckers, aged 18-55 years.
RESULTS


Consuming DFS significantly (P = 0·01) predicted resolution of Fe deficiency (relative risk (RR) = 2·31) and of low BI (RR = 2·78) compared with consuming iodized salt. Baseline sFt (β = -0·32 (se 0·03), P < 0·001) and treatment group (β = 0·13 (se 0·03), P < 0·001) significantly predicted change in sFt. The interaction of baseline BI with treatment group (β = -0·11 (se 0·06), P = 0·08) predicted the change in BI. DFS did not significantly predict change in Hb and marginally predicted resolution of anaemia (Hb < 120 g/l).
CONCLUSIONS


Baseline Fe status, as assessed by sFt and BI, and consumption of DFS predict change in Fe status and resolution of Fe deficiency and low BI. Anaemia prevalence and Hb level, although simple and inexpensive to measure, may not be adequate to predict resolution of Fe deficiency in response to an intervention of DFS in similar populations with high prevalence of Fe deficiency and multiple nutritional causes of anaemia. These findings will guide appropriate targeting of future interventions.",2019,"Anaemia prevalence and Hb level, although simple and inexpensive to measure, may not be adequate to predict resolution of Fe deficiency in response to an intervention of DFS in similar populations with high prevalence of Fe deficiency and multiple nutritional causes of anaemia.","['female Indian tea pluckers', 'A tea estate in West Bengal, India', 'Female tea pluckers, aged 18-55 years']","['dietary Fe intervention', 'salt double-fortified with iodine and Fe (DFS', 'double-fortified salt']","['Anaemia prevalence and Hb level', 'sFt and BI, and consumption of DFS predict change in Fe status and resolution of Fe deficiency and low BI', 'resolution of Fe deficiency (relative risk (RR) ', 'change in BI', 'Fe status and resolution of Fe deficiency (serum ferritin (sFt) &lt; 12 μg/l) and low body Fe (body Fe (BI', 'resolution of anaemia']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0444826', 'cui_str': 'Bengal (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}]",,0.113184,"Anaemia prevalence and Hb level, although simple and inexpensive to measure, may not be adequate to predict resolution of Fe deficiency in response to an intervention of DFS in similar populations with high prevalence of Fe deficiency and multiple nutritional causes of anaemia.","[{'ForeName': 'Julie Eh', 'Initials': 'JE', 'LastName': 'Nevins', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Savage Hall, 244 Garden Avenue, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Venkatramanan', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Savage Hall, 244 Garden Avenue, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Savage Hall, 244 Garden Avenue, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Jere D', 'Initials': 'JD', 'LastName': 'Haas', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Savage Hall, 244 Garden Avenue, Ithaca, NY, 14853, USA.'}]",Public health nutrition,['10.1017/S1368980019001800']
3453,31907525,Skeletal Muscle Energetics and Mitochondrial Function Are Impaired Following 10 Days of Bed Rest in Older Adults.,"BACKGROUND


Older adults exposed to periods of inactivity during hospitalization, illness, or injury lose muscle mass and strength. This, in turn, predisposes poor recovery of physical function upon reambulation and represents a significant health risk for older adults. Bed rest (BR) results in altered skeletal muscle fuel metabolism and loss of oxidative capacity that have recently been linked to the muscle atrophy program. Our primary objective was to explore the effects of BR on mitochondrial energetics in muscle from older adults. A secondary objective was to examine the effect of β-hydroxy-β-methylbuturate (HMB) supplementation on mitochondrial energetics.
METHODS


We studied 20 older adults before and after a 10-day BR intervention, who consumed a complete oral nutritional supplement (ONS) with HMB (3.0 g/d HMB, n = 11) or without HMB (CON, n = 9). Percutaneous biopsies of the vastus lateralis were obtained to determine mitochondrial respiration and H2O2 emission in permeabilized muscle fibers along with markers of content. RNA sequencing and lipidomics analyses were also conducted.
RESULTS


We found a significant up-regulation of collagen synthesis and down-regulation of ribosome, oxidative metabolism and mitochondrial gene transcripts following BR in the CON group. Alterations to these gene transcripts were significantly blunted in the HMB group. Mitochondrial respiration and markers of content were both reduced and H2O2 emission was elevated in both groups following BR.
CONCLUSIONS


In summary, 10 days of BR in older adults causes a significant deterioration in mitochondrial energetics, while transcriptomic profiling revealed that some of these negative effects may be attenuated by an ONS containing HMB.",2020,"We found a significant up-regulation of collagen synthesis and down-regulation of ribosome, oxidative metabolism and mitochondrial gene transcripts following BR in the CON group.","['20 older adults before and after a 10-day BR intervention, who consumed a complete oral nutritional supplement (ONS) with β-hydroxy-β-methylbuturate (HMB) (3.0g/d HMB, n=11) or without HMB (CON, n=9', 'Older adults', 'muscle from older adults', 'older adults']","['Bed rest (BR', 'β-hydroxy-β-methylbuturate (HMB) supplementation']","['H2O2 emission', 'Mitochondrial respiration and markers of content']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0233929', 'cui_str': 'Emission (finding)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",20.0,0.1099,"We found a significant up-regulation of collagen synthesis and down-regulation of ribosome, oxidative metabolism and mitochondrial gene transcripts following BR in the CON group.","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Standley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Distefano', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Michelle B', 'Initials': 'MB', 'LastName': 'Trevino', 'Affiliation': 'Center for Metabolic Origins of Disease, Sanford Burnham Prebys Medical Discovery Institute, Orlando, Florida.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'BERG LLC, Framingham, Massachusetts.'}, {'ForeName': 'Niven R', 'Initials': 'NR', 'LastName': 'Narain', 'Affiliation': 'BERG LLC, Framingham, Massachusetts.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'BERG LLC, Framingham, Massachusetts.'}, {'ForeName': 'Gramoz', 'Initials': 'G', 'LastName': 'Kondakci', 'Affiliation': 'BERG LLC, Framingham, Massachusetts.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Tolstikov', 'Affiliation': 'BERG LLC, Framingham, Massachusetts.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kiebish', 'Affiliation': 'BERG LLC, Framingham, Massachusetts.'}, {'ForeName': 'Gongxin', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qi', 'Affiliation': 'Center for Metabolic Origins of Disease, Sanford Burnham Prebys Medical Discovery Institute, Orlando, Florida.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kelly', 'Affiliation': 'Center for Metabolic Origins of Disease, Sanford Burnham Prebys Medical Discovery Institute, Orlando, Florida.'}, {'ForeName': 'Rick B', 'Initials': 'RB', 'LastName': 'Vega', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Coen', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Bret H', 'Initials': 'BH', 'LastName': 'Goodpaster', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa001']
3454,31647147,Efficacy of EPA-enriched supplement compared with standard formula on body weight changes in malnourished patients with head and neck cancer undergone surgery: a randomized study.,"BACKGROUND


Eicosapentaenoic acid (EPA) containing nutritional supplement can reverse weight loss and increase lean body mass in a perioperative period of patients with head and neck cancer. To study effects of an EPA-enriched supplement compared with a conventional supplement in malnourished patients with head and neck cancer following surgery is primary objective.
METHODS


The patients were randomized into EPA-enriched and standard formula group. The supplements were prescribed 7 days preoperative through 14 days postoperative. Body weight and composition including serum parameters were measured from 7 days preoperative until 4 months postoperative. The hospitalized courses were recorded.
RESULTS


Thirty-one patients in each group consumed EPA-enriched and standard formula supplements. There was no significant body weight or composition changes perioperative. No significant differences in the hospitalized days and postoperative complications was observed.
CONCLUSIONS


Body weight changes in malnourished patients with head and neck cancer following surgery were not influenced by EPA additives to perioperative nutritional supplements.",2020,"No significant differences in the hospitalized days and postoperative complications was observed.
","['malnourished patients with head and neck cancer undergone surgery', 'malnourished patients with head and neck cancer following surgery is primary objective', 'malnourished patients with head and neck cancer following surgery', 'patients with head and neck cancer']","['EPA-enriched supplement', 'Eicosapentaenoic acid (EPA) containing nutritional supplement', 'standard formula', 'conventional supplement', 'EPA-enriched and standard formula group']","['body weight changes', 'body weight or composition changes perioperative', 'hospitalized days and postoperative complications', 'weight loss', 'Body weight and composition including serum parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]","[{'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",31.0,0.0424572,"No significant differences in the hospitalized days and postoperative complications was observed.
","[{'ForeName': 'Kitti', 'Initials': 'K', 'LastName': 'Jantharapattana', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Orachat', 'Initials': 'O', 'LastName': 'Orapipatpong', 'Affiliation': ''}]",Head & neck,['10.1002/hed.25987']
3455,31236874,Improvement in 6-min Walk Test Distance Following Treatment for Behavioral Weight Loss and Disinhibited Eating: an Exploratory Secondary Analysis.,"BACKGROUND


Poor functional exercise capacity is common among those with obesity; however, objective measures of exercise capacity are rarely examined in behavioral treatments targeting obese individuals. We examined whether a 4-week acceptance and commitment therapy (ACT) intervention for disinhibited eating or a behavioral weight loss (BWL) intervention improved exercise capacity and explored demographic and disinhibited eating variables related to exercise capacity.
METHODS


Veterans (n = 61), randomized to receive ACT or BWL, completed an assessment of exercise capacity via the 6-min walk test (6MWT) at baseline and 6-month follow-up. Measures of disinhibited eating patterns and body mass index (BMI), at baseline and post-treatment, were also collected. Change in 6MWT distance and treatment group differences were examined using mixed ANOVAs. Characteristics related to baseline 6MWT and predictors of improvement in 6MWT at 6 months were examined with hierarchical multiple regression.
RESULTS


There were overall significant improvements on the 6MWT from baseline to 6-month follow-up (F(1,59) = 11.14, p = .001, η p 2  = .159) but no differences between the ACT and BWL groups. Baseline BMI (β = - .33, p = .005) was the only variable related to baseline 6MWT. Improvements on the 6MWT were related to younger age (β = - .41, p = 0.001), female gender (β = .36, p = .001), and treatment-related increases in dietary restraint behaviors (β = .42, p = .001).
CONCLUSIONS


Functional exercise capacity improved among participants completing behavioral interventions for weight and disinhibited eating. Improvements in dietary behavior regulatory skills may have generalized to improved regulation in other behavioral domains associated with exercise capacity.",2019,Improvements on the 6MWT were related to younger age (β ,"['Veterans (n\u2009=\u200961', 'participants completing behavioral interventions for weight and disinhibited eating']","['ACT or BWL, completed an assessment of exercise capacity via the 6-min walk test (6MWT', '4-week acceptance and commitment therapy (ACT) intervention for disinhibited eating or a behavioral weight loss (BWL) intervention']","['Baseline BMI', 'Behavioral Weight Loss and Disinhibited Eating', 'disinhibited eating patterns and body mass index (BMI', '6MWT', 'female gender (β', 'dietary restraint behaviors (β\u2009']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0492712,Improvements on the 6MWT were related to younger age (β ,"[{'ForeName': 'Jennalee S', 'Initials': 'JS', 'LastName': 'Wooldridge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Herbert', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hernandez', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Dochat', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego, CA, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Center for Weight, Eating and Lifestyle Science (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Gasperi', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Afari', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA. nafari@ucsd.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09796-1']
3456,31301164,Attachment and compassion-threat: Influence of a secure attachment-prime.,"OBJECTIVES


The present paper proposed and tested a methodology for reducing individual's threat response to compassion-imagery, by increasing their levels of state attachment-security.
DESIGN


A total of 68 University students (63% female, mean age = 25) completed an experimental study, where they were randomly assigned to either a 10-min attachment-prime (to enhance attachment-security) or an interpersonal skills module (control condition).
METHODS


Participants completed a compassion-focused imagery exercise before and after the manipulation, to determine the effects of the attachment-prime. To measure the effects of the manipulation on individual's threat response, heart rate variability data were collected at baseline and during both compassion exercises.
RESULTS


As predicted, individuals who reported higher levels of anxious and avoidant attachment styles were more likely to display a threat response (decreases in heart rate variability), to the first compassion-focused imagery. After receiving an attachment-prime, heart rate variability increased suggesting that individual's experienced greater self-soothing responses and decreased threat responses to the second compassion-focused imagery.
CONCLUSIONS


The present findings suggest that individuals with insecure attachments are likely to require additional support increasing their attachment-security, before they can successfully engage in compassion-based exercises or therapies.
PRACTITIONER POINTS


Compassion-based exercises may result in fear and consequently avoidance in some populations of individuals. Threat responses to compassion can be reduced by using attachment-based techniques. Research findings will help inform and broaden the clinical applicability of compassion-based therapies.",2020,"After receiving an attachment-prime, heart rate variability increased suggesting that individual's experienced greater self-soothing responses and decreased threat responses to the second compassion-focused imagery.
","['Participants completed a', '68 University students (63% female, mean age\xa0=\xa025) completed an experimental study']","['compassion-focused imagery exercise', '10-min attachment-prime (to enhance attachment-security) or an interpersonal skills module (control condition', 'secure attachment-prime']","['heart rate variability', 'levels of anxious and avoidant attachment styles', 'Attachment and compassion-threat']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0582757', 'cui_str': 'Secure attachment (finding)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",68.0,0.035741,"After receiving an attachment-prime, heart rate variability increased suggesting that individual's experienced greater self-soothing responses and decreased threat responses to the second compassion-focused imagery.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baldwin', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Bandarian-Balooch', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia.'}]",Psychology and psychotherapy,['10.1111/papt.12244']
3457,31274345,The effect of diurnal variation in exercise-induced bronchoconstriction.,"Objective:  Exercise-induced bronchoconstriction (EIB) is an acute, transient narrowing of the airway as a result of exercise. Diurnal variation in asthma is well-established, however, few studies have investigated diurnal variability in EIB; no study has used eucapnic voluntary hyperpnea (EVH). The aim of this study was to examine circadian variability in EIB using EVH. Methods:  Fourteen recreationally-active males with mild to moderate asthma and nine healthy controls were randomized to first complete either an AM (07:00-08:00) or PM (17:00-18:00) EVH challenge, followed by the alternate test 34 h to 7 days later. The EVH protocol comprised of six-minutes of hyperventilation of a 5% CO 2  gas at a minimum ventilation rate of 21 × FEV 1  min -1 . The primary outcome measure was FEV 1  pre- and post-EVH. Results:  We observed no diurnal effect on EIB in the asthma group. The minimum observed post-EVH FEV 1  in the asthma cohort was 3.58 ± 0.95 L in AM and 3.62 ± 0.87 L in PM tests, corresponding to a 15.0 ± 15.3% vs. 14.9 ± 14.7% reduction from baseline, respectively. The asthma group showed similar baseline FEV 1  before AM (4.21 ± 0.79 L) and PM (4.25 ± 0.65 L) tests. No difference was observed in minute ventilation between AM (26.1 ± 3.4 × FEV 1  min -1 ) and PM (25.6 ± 3.8 × FEV 1  min -1 ) tests for the asthma cohort. Controls displayed no significant changes in FEV 1  or minute ventilation between tests. Conclusions:  When baseline pulmonary function is similar, this study suggests that time-of-day has no effect on EIB in mild to moderate asthma.",2020,Controls displayed no significant changes in FEV 1  or minute ventilation between tests.  ,['Fourteen recreationally-active males with mild to moderate asthma and nine healthy controls'],['Exercise-induced bronchoconstriction (EIB'],"['FEV 1  or minute ventilation', 'FEV 1  pre- and post-EVH', 'minute ventilation']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",,0.0505209,Controls displayed no significant changes in FEV 1  or minute ventilation between tests.  ,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowe', 'Affiliation': ""Human Performance Laboratory, Discipline of Anatomy, Watt's Building, Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Mahony', 'Affiliation': ""Human Performance Laboratory, Discipline of Anatomy, Watt's Building, Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Fleming', 'Affiliation': ""Human Performance Laboratory, Discipline of Anatomy, Watt's Building, Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Donne', 'Affiliation': ""Human Performance Laboratory, Discipline of Anatomy, Watt's Building, Trinity College Dublin, Dublin, Ireland.""}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2019.1640731']
3458,31755872,Mood Monitoring Over One Year for People With Chronic Obstructive Pulmonary Disease Using a Mobile Health System: Retrospective Analysis of a Randomized Controlled Trial.,"BACKGROUND


Comorbid anxiety and depression can add to the complexity of managing treatment for people living with chronic obstructive pulmonary disease (COPD). Monitoring mood has the potential to identify individuals who might benefit from additional support and treatment.
OBJECTIVE


We used data from the sElf-management anD support proGrammE (EDGE) trial to examine: (1) the extent to which the mood-monitoring components of a mobile health system for patients with COPD were used by participants; (2) the levels of anxiety and depression symptoms among study participants; (3) the extent to which videos providing advice about coping with low mood were viewed; and (4) the characteristics of participants with differing levels of mood and utilization of mood monitoring.
METHODS


A total of 107 men and women with a clinical diagnosis of COPD, aged ≥40 years old, were recruited to the intervention arm of the EDGE trial. Participants were invited to complete the Patient Health Questionnaire-8 and the Generalized Anxiety Disorder-7 test every four weeks using a tablet computer. Mood disturbance based on these measures was defined as a score ≥5 on either scale. Participants reporting a mood disturbance were automatically directed (signposted) to a stress or mood management video. Study outcomes included measures of health status, respiratory quality of life, and symptoms of anxiety and depression.
RESULTS


Overall, 94 (87.9%) participants completed the 12-month study. A total of 80 participants entered at least one response each month for at least ten months. On average, 16 participants (range 8-38 participants) entered ≥2 responses each month. Of all the participants, 47 (50%) gave responses indicating a mood disturbance. Participants with a mood disturbance score for both scales (n=47) compared with those without (n=20) had lower health status (P=.008), lower quality of life (P=.009), and greater anxiety (P<.001) and increased depression symptoms (P<.001). Videos were viewed by 64 (68%) people over 12 months. Of the 220 viewing visualizations, 70 (34.7%) began after being signposted. Participants signposted to the stress management video (100%; IQR 23.3-100%) watched a greater proportion of it compared to those not signposted (38.4%; IQR 16.0-68.1%; P=.03), whereas duration of viewing was not significantly different for the mood management video.
CONCLUSIONS


Monitoring of anxiety and depression symptoms for people with COPD is feasible. More than half of trial participants reported scores indicating a mood disturbance during the study. Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video. The opportunity to elicit measures of mood regularly as part of a health monitoring system could contribute to better care for people with COPD.",2019,Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video.,"['107 men and women with a clinical diagnosis of COPD, aged ≥40 years old', 'people living with chronic obstructive pulmonary disease (COPD', 'People With Chronic Obstructive Pulmonary Disease', 'people with COPD', '16 participants (range 8-38 participants) entered ≥2 responses each month', 'patients with COPD were used by participants; (2) the levels of anxiety and depression symptoms among study participants; (3) the extent to which videos providing advice about coping with low mood were viewed; and (4) the characteristics of participants with differing levels of mood and utilization of mood monitoring', '80 participants entered at least one response each month for at least ten months']",[],"['Mood disturbance', 'mood disturbance score', 'stress management video', 'mood disturbance', 'lower quality of life', 'lower health status', 'duration of viewing', 'health status, respiratory quality of life, and symptoms of anxiety and depression', 'depression symptoms']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0424113', 'cui_str': 'Level of mood (observable entity)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",[],"[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",38.0,0.135796,Signposting participants to an advisory video when reporting increased symptoms of a mood disturbance resulted in a longer view-time for the stress management video.,"[{'ForeName': 'Maxine E', 'Initials': 'ME', 'LastName': 'Whelan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rutter', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/14946']
3459,31895867,Three-month Storage of Human Corneas in an Active Storage Machine.,"BACKGROUND


Corneal storage for the very long term, without degradation, would make it possible to optimize a very limited resource worldwide. We previously demonstrated the superiority, compared to conventional 4-week passive organ culture (OC), of an active storage machine (ASM) that restores intraocular pressure and medium renewal. Here, we investigate eye banking for up to 3 months.
METHODS


In a randomized preclinical trial with 24 paired corneas, 1 was stored in OC and the other in ASM, using the same medium. Assessments were done on the second day and at 3 months: endothelial cell density (ECD in cells/mm), corneal transparency and thickness. At day 86, OC corneas were deswelled in a common hyperosmotic medium, but not the ASM corneas, which had remained thin. In addition, at day 88, viable ECD was measured using a live/dead assay, and endothelial expression of Na/K ATPase, Cox IV, ZO-1, N-CAM, and CD166 was observed.
RESULTS


The ASM extended storage to 3 months with unprecedented endothelial cell quality: no OC corneas remained suitable for transplantation, but one-third of ASM corneas were compliant (ECD > 2000/mm). Given that corneas with ECD > 1600/mm were also usable for emergency, 58% of ASM corneas were usable versus 33% in OC. EC survival was 53% higher in ASM (P < 0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
CONCLUSIONS


By extending graft survival to 3 months, the ASM will optimize eye banking and open up new perspectives in experimental research.",2020,"EC survival was 53% higher in ASM (p<0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
",[],"['conventional 4-week passive organ culture (OC), of an active storage machine (ASM']","['live/dead assay, and endothelial expression of Na/KATPase, Cox-IV, ZO-1, N-CAM and CD166', 'endothelial cell density (ECD in cells/mm), corneal transparency and thickness', 'EC survival']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029205', 'cui_str': 'Organ Culture Techniques'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}]","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0431232,"EC survival was 53% higher in ASM (p<0.001), structural and functional proteins of ECs were much better preserved in ASM, and it prevented the constant major edema of OC.
","[{'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Garcin', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Gauthier', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Crouzet', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Herbepin', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Perrache', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Acquart', 'Affiliation': 'Eye Bank, French Blood Center, Saint-Etienne, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Cognasse', 'Affiliation': 'Eye Bank, French Blood Center, Saint-Etienne, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Forest', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gain', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Thuret', 'Affiliation': 'Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint-Etienne, France.'}]",Transplantation,['10.1097/TP.0000000000003109']
3460,31960448,"Effect of short-term vitamin D supplementation after nonsurgical periodontal treatment: A randomized, double-masked, placebo-controlled clinical trial.","OBJECTIVES


This trial aimed to evaluate the efficacy and safety of vitamin D supplementation on the residual moderate and deep pockets following nonsurgical periodontal therapy.
BACKGROUND


Vitamin D supplementation has potential effects on periodontitis, but current evidence remains inconclusive.
METHODS


After 3 months of nonsurgical periodontal treatment, 360 patients with moderate or severe periodontitis were randomly assigned to 2000 international unit (IU)/d vitamin D3, 1000 IU/d vitamin D3, or placebo. Clinical periodontal examinations, including probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH), were performed at baseline and after 3 months of intervention.
RESULTS


There was a slight but significant decrease in AL and PD in both vitamin D groups compared with placebo group for moderate and deep pockets. About 2000 IU/d vitamin D3 group, 1000 IU/d vitamin D3 group, and placebo group all decreased the AL for both moderate pockets (-0.4 mm vs -0.4 mm vs -0.3 mm) and deep pockets (-1.1 mm vs -1.1 mm vs -1.0 mm) (all P < .05). Similarly, PD was also decreased in these three groups for both moderate pockets and deep pockets (all P < .05). In addition, vitamin D supplementation was well tolerated, and no adverse events were reported.
CONCLUSIONS


Although statistically significant differences were observed in favor to vitamin D supplementation, the magnitude of effect size tended to be modest with limited clinical relevance and the long-term efficacy and safety warrant further investigation.",2020,"Clinical periodontal examinations, including probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH), were performed at baseline and after 3 months of intervention.
",['360 patients with moderate or severe periodontitis'],"['IU/d vitamin D3', '2000 international unit (IU)/d vitamin D3, 1000\xa0IU/d vitamin D3, or placebo', 'Vitamin D supplementation', 'short-term vitamin D supplementation', 'placebo', 'vitamin D3', 'vitamin D supplementation']","['tolerated, and no adverse events', 'probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH', 'AL and PD', 'deep pockets']","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C2948667', 'cui_str': 'Crest'}]",360.0,0.430091,"Clinical periodontal examinations, including probing depth (PD), bleeding index (BI), plaque index (PLI), attachment loss (AL), and alveolar crest height (ACH), were performed at baseline and after 3 months of intervention.
","[{'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huilin', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Zuomin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.'}]",Journal of periodontal research,['10.1111/jre.12719']
3461,32001003,Long-term effectiveness of two models of brief psychotherapy for depression: A three-year follow-up randomized clinical trial.,"Major depressive disorder (MDD) is a disease that severely impairs psychosocial functioning and decreases the subject's quality of life. Patients who received psychotherapy have a better long-term therapeutic response than those who have only been treated with antidepressants or have not been treated. There are few studies in the literature that follow the outcomes of psychotherapeutic treatments for depression for more than two years. The aim of this study is to compare the therapeutic response of two models of brief psychotherapy for MDD treatment (Cognitive Behavioral Therapy and Short-term Psychodynamic Psychotherapy) with naturalistic controls who received treatment as usual in a three-year follow-up. This is a sample of 75 outpatients, mostly women (82.7%), with a median age of 33 (27-44). The interventions took place in 50-minute sessions once a week for 14 to 16 weeks. Outcomes were assessed at baseline and three years after the intervention. Regarding depressive symptoms, the therapeutic response was maintained three years after the conclusion of the brief models of psychotherapy. Functional capacity long-term maintenance depended not only on the intervention but also on the education level, the work situation and the severity of depressive symptoms at the beginning of the treatment.",2020,Patients who received psychotherapy have a better long-term therapeutic response than those who have only been treated with antidepressants or have not been treated.,"['75 outpatients, mostly women (82.7%), with a median age of 33 (27-44', 'Major depressive disorder (MDD', 'depression']","['psychotherapy for MDD treatment (Cognitive Behavioral Therapy and Short-term Psychodynamic Psychotherapy', 'psychotherapy']","['severity of depressive symptoms', 'Functional capacity long-term maintenance', 'better long-term therapeutic response']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}]",75.0,0.0368115,Patients who received psychotherapy have a better long-term therapeutic response than those who have only been treated with antidepressants or have not been treated.,"[{'ForeName': 'Érico Nobre', 'Initials': 'ÉN', 'LastName': 'Dos Santos', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil. Electronic address: ericons@gmail.com.'}, {'ForeName': 'Mariane Lopez', 'Initials': 'ML', 'LastName': 'Molina', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil; Faculdade Anhanguera do Rio Grande, Av. Rheingantz, 91 - Pq. Residencial Coelho, Rio Grande 96202-110 RS, Brazil.'}, {'ForeName': 'Thaise', 'Initials': 'T', 'LastName': 'Mondin', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil; Pró-Reitoria de Assuntos Estudantis - Universidade Federal de Pelotas (UFPel), Rua Almirante Barroso, 1202, Centro, Pelotas 96010-280 RS, Brazil.'}, {'ForeName': 'Taiane de Azevedo', 'Initials': 'TA', 'LastName': 'Cardoso', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil; Department of Psychiatry and Behavioural Neurosciences, McMaster University, 100 West 5th Street, Research Office G110 ON L8N 3K7 Hamilton, Canada.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Souza', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jansen', 'Affiliation': 'Programa de Pós-Graduação em Saúde e Comportamento, Universidade Católica de Pelotas (UCPel), Rua Gonçalves Chaves, 373, sala 424 C, Pelotas 96015-560 RS, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.112804']
3462,32196390,"Adaptation of the ""active communication education"" programme into Spanish for older adults with hearing loss.","Objective:  To adapt the Active Communication Education (ACE) programme into Spanish. In addition, this study aimed at determining the effects of the adapted ACE programme on the social/emotional impacts of hearing loss and hearing functioning in a group of older adults with hearing loss who do not wear hearing aids. Design:  This was an exploratory cohort study. Study group participants received the newly adapted ACE programme and control group participants received a cognitive stimulation programme. The Shortened Hearing Handicap Inventory for the Elderly in Spanish (HHIE-S) and the Spanish version of the Amsterdam Inventory for Auditory Disability and Handicap (S-AIADH) were carried out before and after each programme. Study sample:  Sixty-six older adults with hearing loss and who did not wear hearing aids were randomly assigned to either an ACE group ( n  = 30) or a cognitive stimulation group ( n  = 36). Results:  Participants who received the ACE programme showed a significantly larger improvement for the S-AIADH than did the cognitive stimulation group participants. Conclusions:  The ACE programme has been adapted into Spanish for use with Chilean older adults with hearing loss. The results show that older adults report better functioning in listening situations after attending the sessions of the adapted ACE programme.",2020,showed a significantly larger improvement for the S-AIADH than did the cognitive stimulation group participants.,"['Chilean older adults with hearing loss', 'older adults with hearing loss', 'Study sample:  Sixty-six older adults with hearing loss and who did not wear hearing aids', 'older adults with hearing loss who do not wear hearing aids']","['newly adapted ACE programme and control group participants received a cognitive stimulation programme', 'adapted ACE programme', 'ACE programme', 'active communication education"" programme', 'ACE', 'cognitive stimulation group', 'Active Communication Education (ACE) programme']","['hearing loss and hearing functioning', 'Shortened Hearing Handicap Inventory', 'S-AIADH']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}]","[{'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",66.0,0.0212108,showed a significantly larger improvement for the S-AIADH than did the cognitive stimulation group participants.,"[{'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Rivera', 'Affiliation': 'Escuela de Fonoaudiología, Facultad de Salud, Universidad Santo Tomás, Viña del Mar, Chile.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Marcotti', 'Affiliation': 'Departamento de Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Fuente', 'Affiliation': 'Department of Speech and Hearing Sciences [Departamento de Fonoaudiología], Faculty of Medicine, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Fuentes-López', 'Affiliation': 'Departamento de Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hickson', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]",International journal of audiology,['10.1080/14992027.2020.1740801']
3463,32196793,DASH (Dietary Approaches to Stop Hypertension) dietary pattern and maternal blood pressure in pregnancy.,"BACKGROUND


High blood pressure (BP) in pregnancy is associated with significant adverse outcomes. In nonpregnant populations, the DASH (Dietary Approaches to Stop Hypertension) diet is associated with reductions in blood pressure. The present study investigated the relationship between the DASH dietary pattern and maternal BP in pregnancy.
METHODS


This is an observational study of 511 women who participated in the ROLO study (Randomized cOntrol trial of LOw glycaemic index diet for the prevention of recurrence of macrosomia), 2007-2011, Dublin, Ireland. Auscultatory blood pressure, systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were taken. Mean arterial pressure (MAP) was calculated. Dietary intakes were recorded using 3-day food diaries in each trimester. DASH scoring criteria were used to score and rank participants from low to high intakes of foods recommended in the DASH diet. Statistical analysis using analysis of variance and multiple linear regression were used to determine the relationship between maternal BP and DASH scores.
RESULTS


Dietary intake more closely resembling the DASH dietary recommendations throughout pregnancy was associated with a lower DBP (mmHg) in trimesters 1 [B: -0.70; 95% confidence interval (CI) = -1.21 to -0.18] and 3 (B: -0.68; 95% CI = -1.19 to -0.17), as well as lower MAP (mmHg) in trimesters 1 (B: -0.78; 95% CI = -1.33 to -0.25) and 3 (B: -0.54; 95% CI = -1.04 to -0.04), controlling for body mass index, age, education, energy intake and intervention grouping.
CONCLUSIONS


The DASH dietary pattern was associated with lower maternal BP in pregnancy among healthy women without hypertensive disorders of pregnancy. Despite the observational nature of these findings, the results demonstrate the potential for healthcare professionals to intervene to promote cardiovascular health in pregnancy.",2020,"In nonpregnant populations, the DASH (Dietary Approaches to Stop Hypertension) diet is associated with reductions in blood pressure.","['511 women who participated in the ROLO study (Randomized cOntrol trial of', 'healthy women without hypertensive disorders of pregnancy']",['LOw glycaemic index diet'],"['Dietary intakes', 'maternal BP and DASH scores', 'Mean arterial pressure (MAP', 'Auscultatory blood pressure, systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements', 'blood pressure', 'maternal BP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",511.0,0.0466528,"In nonpregnant populations, the DASH (Dietary Approaches to Stop Hypertension) diet is associated with reductions in blood pressure.","[{'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Courtney', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Crowley', 'Affiliation': ""Department of Endocrinology, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Geraghty', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Brady', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Kilbane', 'Affiliation': ""Department of Clinical Chemistry, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Twomey', 'Affiliation': ""Department of Clinical Chemistry, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'McKenna', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12744']
3464,32186160,"Acupuncture treatment of lung-spleen Qi deficiency in stable chronic obstructive pulmonary disease: a randomized, open-label, controlled trial.","OBJECTIVE


To evaluate the effectiveness and safety of acupuncture that reinforces the spleen to strengthen the lung in patients with stable chronic obstructive pulmonary disease (COPD).
METHODS


This was a randomized, open-controlled trial in which the acupuncturist and the participants were not blinded, but the outcome evaluators and data analysts were blinded. One-hundred-and-two patients with stable COPD were randomly divided into two groups in a 1∶1 ratio. The acupuncture group received 30-minute sessions of acupuncture therapy at the same acupoints three times weekly for 6 weeks in addition to routine conventional Western Medicine treatment; the control group received routine conventional Western Medicine treatment alone. The primary outcome was the Borg scale score, which was assessed immediately after the 6-minute walk test. The secondary outcomes were the 6-minute walk distance, lung function, and oxygen saturation. Measurements were obtained at baseline and after 6 weeks of treatment.
RESULTS


After 6 weeks of treatment, the Borg scale score in the acupuncture group was significantly better than that in the control group (2.02 ± 0.71 versus 5.01 ± 0.34, P < 0.05). Furthermore, the post-treatment improvements in the 6-minute walk distance, lung function, and oxygen saturation were significantly greater in the acupuncture group than in the control group, showing that the acupuncture group had better exercise tolerance.
CONCLUSION


The findings suggest that acupuncture that aims to reinforce the spleen to strengthen the lung is a safe and effective adjuvant therapy that effectively improves the exercise capacity of patients with stable COPD.",2019,"After 6 weeks of treatment, the Borg scale score in the acupuncture group was significantly better than that in the control group (2.02 ± 0.71 versus 5.01 ± 0.34, P < 0.05).","['patients with stable chronic obstructive pulmonary disease (COPD', 'patients with stable COPD', 'One-hundred-and-two patients with stable COPD', 'stable chronic obstructive pulmonary disease']","['acupuncture', 'acupuncture therapy', 'Acupuncture', 'routine conventional Western Medicine treatment alone']","['Borg scale score', '6-minute walk distance, lung function, and oxygen saturation', 'effectiveness and safety', 'exercise tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",102.0,0.0806866,"After 6 weeks of treatment, the Borg scale score in the acupuncture group was significantly better than that in the control group (2.02 ± 0.71 versus 5.01 ± 0.34, P < 0.05).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Xiong', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Guangtong', 'Initials': 'G', 'LastName': 'Zhuang', 'Affiliation': 'Cardiovascular Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Chenyi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Respiratory Department, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Research, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Erqi', 'Initials': 'E', 'LastName': 'Qin', 'Affiliation': 'Department of Research, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Research, No. 3 Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (West District), Chengdu Pidu District Hospital of Traditional Chinese Medicine, Chengdu 611730, China.'}, {'ForeName': 'Juanjuan', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,[]
3465,30804399,"The effects of a single session of chiropractic care on strength, cortical drive, and spinal excitability in stroke patients.","The objective of this study was to investigate whether a single session of chiropractic care could increase strength in weak plantar flexor muscles in chronic stroke patients. Maximum voluntary contractions (strength) of the plantar flexors, soleus evoked V-waves (cortical drive), and H-reflexes were recorded in 12 chronic stroke patients, with plantar flexor muscle weakness, using a randomized controlled crossover design. Outcomes were assessed pre and post a chiropractic care intervention and a passive movement control. Repeated measures ANOVA was used to asses within and between group differences. Significance was set at p < 0.05. Following the chiropractic care intervention there was a significant increase in strength (F (1,11) = 14.49, p = 0.002; avg 64.2 ± 77.7%) and V-wave/Mmax ratio (F(1,11) = 9.67, p = 0.009; avg 54.0 ± 65.2%) compared to the control intervention. There was a significant strength decrease of 26.4 ± 15.5% (p = 0.001) after the control intervention. There were no other significant differences. Plantar flexor muscle strength increased in chronic stroke patients after a single session of chiropractic care. An increase in V-wave amplitude combined with no significant changes in H-reflex parameters suggests this increased strength is likely modulated at a supraspinal level. Further research is required to investigate the longer term and potential functional effects of chiropractic care in stroke recovery.",2019,There was a significant strength decrease of 26.4 ± 15.5% (p = 0.001) after the control intervention.,"['chronic stroke patients', '12 chronic stroke patients, with plantar flexor muscle weakness', 'chronic stroke patients after a single session of chiropractic care', 'stroke patients']",['chiropractic care'],"['strength', 'Maximum voluntary contractions (strength) of the plantar flexors, soleus evoked V-waves (cortical drive), and H-reflexes', 'Plantar flexor muscle strength', 'strength, cortical drive, and spinal excitability']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0151786', 'cui_str': 'Muscular Weakness'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0008138', 'cui_str': 'Chiropractic'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C4301968', 'cui_str': 'v wave (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",12.0,0.0217576,There was a significant strength decrease of 26.4 ± 15.5% (p = 0.001) after the control intervention.,"[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand.'}, {'ForeName': 'Imran Khan', 'Initials': 'IK', 'LastName': 'Niazi', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand.'}, {'ForeName': 'Rasmus Wiberg', 'Initials': 'RW', 'LastName': 'Nedergaard', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Duehr', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Amjad', 'Affiliation': 'Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shafique', 'Affiliation': 'Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Muhammad Nabeel', 'Initials': 'MN', 'LastName': 'Anwar', 'Affiliation': 'National University of Science and Technology, Islamabad, Pakistan.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Ndetan', 'Affiliation': 'University of North Texas Health Science Center, Tylers, Texas, USA.'}, {'ForeName': 'Kemal S', 'Initials': 'KS', 'LastName': 'Turker', 'Affiliation': 'School of Medicine, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Haavik', 'Affiliation': 'Centre for Chiropractic Research, New Zealand College of Chiropractic, Auckland, New Zealand. heidi.haavik@nzchiro.co.nz.'}]",Scientific reports,['10.1038/s41598-019-39577-5']
3466,31425640,The diagnostic performance of novel torque technique for endoscopic ultrasound-guided tissue acquisition in solid pancreatic lesions: A prospective randomized controlled trial.,"BACKGROUND AND AIM


Although several techniques for improved outcomes in endoscopic ultrasound (EUS)-guided tissue acquisition have been reported, the reported diagnostic yield for pancreatic masses is not satisfactory. The effects of novel technique (torque method) on twisting the scope in the clockwise or counterclockwise direction during EUS-fine needle biopsy (EUS-FNB) are unknown. We compared the diagnostic yield of EUS-FNB for pancreatic masses using the torque and standard techniques.
METHODS


From April 20, 2017, to March 16, 2018, 124 consecutive patients with solid pancreatic mass who underwent EUS-FNB using either the torque or standard technique were randomly assigned. Three passes were made with each technique, comprising 10 uniform to-and-fro movements on each pass with a 10-mL syringe suction. The primary outcome was procurement rates of histologic cores, and the secondary outcomes were the diagnostic performance and technical failure.
RESULTS


There were significant differences between the groups regarding the procurement rate of the histologic core and optimal quality core (standard vs torque: 87.1% [54/62] vs 98.4% [61/62], P = 0.038 and 79.0% [49/62] vs 93.5% [58/62], P = 0.037). The sensitivity, specificity, positive predictive value, and negative predictive values of EUS-FNB were 85.45%, 100%, 100%, and 46.67%, respectively, for the standard technique and 96.49%, 100%, 100%, and 71.43%, respectively, for the torque technique. The diagnostic accuracies of the standard and torque techniques were 87.10% and 96.77%, respectively.
CONCLUSIONS


The torque technique for EUS-FNB offered acceptable technical feasibility and superior diagnostic performance, including optimal histologic core procurement, compared with the standard technique.",2020,"The sensitivity, specificity, positive predictive value, and negative predictive values of EUS-FNB were 85.45%, 100%, 100%, and 46.67%, respectively, for the standard technique and 96.49%, 100%, 100%, and 71.43%, respectively, for the torque technique.","['solid pancreatic lesions', 'From 20 April, 2017 to 16 March, 2018, 124 consecutive patients with solid pancreatic mass who underwent EUS-FNB using either the torque or standard technique were randomly assigned']","['novel torque technique for EUS-guided tissue acquisition', 'novel technique (torque method']","['sensitivity, specificity, positive predictive value, and negative predictive values of EUS-FNB', 'procurement rate of the histologic core and optimal quality core', 'diagnostic accuracies of the standard and torque techniques', 'diagnostic performance and technical failure', 'procurement rates of histologic cores']","[{'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas (finding)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",124.0,0.0514653,"The sensitivity, specificity, positive predictive value, and negative predictive values of EUS-FNB were 85.45%, 100%, 100%, and 46.67%, respectively, for the standard technique and 96.49%, 100%, 100%, and 71.43%, respectively, for the torque technique.","[{'ForeName': 'Se Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea.'}, {'ForeName': 'Sang Soo', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae Jun', 'Initials': 'TJ', 'LastName': 'Song', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Koh', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea.'}, {'ForeName': 'Bomi', 'Initials': 'B', 'LastName': 'Hyun', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea.'}, {'ForeName': 'Doocheol', 'Initials': 'D', 'LastName': 'Chung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Shin', 'Affiliation': 'Department of Pathology, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea.'}, {'ForeName': 'Seung-Mo', 'Initials': 'SM', 'LastName': 'Hong', 'Affiliation': 'Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chan Hyuk', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Gyeonggi-do, Korea.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14840']
3467,32109425,"Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial.","BACKGROUND


Gefapixant is a P2X3 receptor antagonist that has shown promise for the treatment of refractory and unexplained chronic cough. The aim of this study was to evaluate the efficacy of gefapixant compared with placebo after 12 weeks of treatment for refractory chronic cough or unexplained chronic cough.
METHODS


We did a 12-week, phase 2b, randomised, double-blind, placebo-controlled study in patients with refractory chronic cough or unexplained chronic cough aged 18-80 years who were recruited from 44 primarily outpatient pulmonologist or allergist sites in the UK and the USA. Eligible patients had refractory or unexplained chronic cough lasting 1 year or longer, no radiographic chest abnormality, and 40 mm or more on a 100-mm cough severity visual analogue scale at enrolment. Patients were randomly assigned to receive placebo or one of three doses (7·5 mg, 20 mg, or 50 mg) of oral gefapixant twice daily, every day, for 84 days; visits to investigative sites were on days 1, 28, 42, 56, 70, 84, and 85. The randomisation schedule was computer generated using a permuted block algorithm by Advance Research Associates (Santa Clara, CA, USA). Patients and all personnel involved in the conduct and interpretation of the study were masked to treatment assignment. The primary endpoint was placebo-adjusted change from baseline in awake cough frequency after 12 weeks, assessed in the full analysis set, which is a subset of the intention-to-treat population. Adverse events were monitored and safety was evaluated in all patients receiving one or more doses of study drug. This trial is registered with ClinicalTrials.gov, NCT02612610.
FINDINGS


Between Dec 21, 2015, and July 26, 2016, 253 patients were randomly assigned to placebo (n=63), gefapixant 7·5 mg (n=64), gefapixant 20 mg (n=63), or gefapixant 50 mg (n=63) twice daily. The mean age of patients was 60·2 (SD 9·9) years and 193 (76%) were women. At 12 weeks, patients' geometric mean awake cough frequency was 18·2 coughs per h (geometric SD 3·1) with placebo, and 14·5 coughs per h (3·7) with 7·5 mg, 12·0 coughs per h (4·2) with 20 mg, and 11·3 coughs per h (2·8) with 50 mg gefapixant. Estimated percentage change relative to placebo was -22·0% (-41·8 to 4·6; p=0·097) with 7·5 mg, -22·2% (-42·0 to 4·3; p=0·093) with 20 mg, and -37·0% (95% CI -53·3 to -14·9; p=0·0027) with 50 mg gefapixant. Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
INTERPRETATION


Targeting purinergic receptor P2X3 with gefapixant at a dose of 50 mg twice daily significantly reduced cough frequency in patients with refractory chronic cough or unexplained chronic cough after 12 weeks of treatment compared with placebo. Further development of gefapixant is warranted for the treatment of chronic cough.
FUNDING


Afferent Pharmaceuticals (acquired by Merck & Co., Inc., Kenilworth, NJ, USA).",2020,"Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
","['patients with refractory chronic cough or unexplained chronic cough aged 18-80 years who were recruited from 44 primarily outpatient pulmonologist or allergist sites in the UK and the USA', 'SD 9·9) years and 193 (76%) were women', 'patients with refractory chronic cough or unexplained chronic cough after 12 weeks of treatment compared with', 'mean age of patients was 60·2', 'Between Dec 21, 2015, and July 26, 2016, 253 patients', 'Eligible patients had refractory or unexplained chronic cough lasting 1 year or longer, no radiographic chest abnormality, and 40 mm or more on a 100-mm cough severity visual analogue scale at enrolment', 'refractory chronic cough or unexplained chronic cough']","['placebo', 'gefapixant', 'oral gefapixant', 'gefapixant 7·5 mg (n=64), gefapixant 20 mg (n=63), or gefapixant 50 mg']","['placebo-adjusted change from baseline in awake cough frequency', 'geometric mean awake cough frequency', 'cough frequency', 'Adverse events', 'Dysgeusia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologists'}, {'cui': 'C0334896', 'cui_str': 'Allergists'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0450402', 'cui_str': '40mm (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}]",253.0,0.672719,"Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
","[{'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity, and Respiratory Medicine, University of Manchester, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK. Electronic address: jacky.smith@manchester.ac.uk.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Alyn H', 'Initials': 'AH', 'LastName': 'Morice', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Lorcan P', 'Initials': 'LP', 'LastName': 'McGarvey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Mandel R', 'Initials': 'MR', 'LastName': 'Sher', 'Affiliation': 'Center for Cough, Largo, FL, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': 'GetStat Solutions, LLC, Palo Alto, CA, USA.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Muccino', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30471-0']
3468,31856942,Guided self-help for depression in autistic adults: the ADEPT feasibility RCT.,"BACKGROUND


Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive-behavioural therapy for depression. To the authors' knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive-behavioural therapy for depression in autism.
OBJECTIVES


The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial.
DESIGN


The study comprised a randomised controlled trial ( n  = 70) with a nested qualitative evaluation ( n  = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual.
SETTING


Adult autism services in two NHS regions.
PARTICIPANTS


Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded.
INTERVENTIONS


The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression.
MAIN OUTCOME MEASURES


Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori.
RESULTS


The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses.
CONCLUSIONS


The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted.
FUTURE WORK


Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN54650760.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.",2019,"Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire.","['Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥\u200910', 'autistic adults', 'n \u2009=\u200970) with a nested qualitative evaluation ( n \u2009=\u200921', 'Adult autism services in two NHS regions', 'People who had attended more than six sessions of cognitive-behavioural therapy in the previous 6 months were excluded', 'Seventy eligible and consenting participants']","['low-intensity cognitive-behavioural therapy', 'guided self-help or to treatment as usual', 'low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision', 'low-intensity psychological intervention']","['self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire', 'differential rates of attrition', 'depressive symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0034375', 'cui_str': 'Qualitative Evaluation'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",70.0,0.116336,"Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive-compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire.","[{'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, Faculty of Humanities and Social Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barton', 'Affiliation': 'Newcastle Cognitive and Behavioural Therapies Centre, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ensum', 'Affiliation': 'BASS Adult Autism Service, Avon & Wiltshire Mental Health Partnership NHS Trust, Bristol, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ingham', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Parr', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Rai', 'Affiliation': 'School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23680']
3469,31523806,"Calcium supplementation commencing before or early in pregnancy, for preventing hypertensive disorders of pregnancy.","BACKGROUND


The hypertensive disorders of pregnancy include pre-eclampsia, gestational hypertension, chronic hypertension, and undefined hypertension. Pre-eclampsia is considerably more prevalent in low-income than in high-income countries. One possible explanation for this discrepancy is dietary differences, particularly calcium deficiency. Calcium supplementation in the second half of pregnancy reduces the serious consequences of pre-eclampsia, but has limited effect on the overall risk of pre-eclampsia. It is important to establish whether calcium supplementation before, and in early pregnancy (before 20 weeks' gestation) has added benefit. Such evidence could count towards justification of population-level interventions to improve dietary calcium intake, including fortification of staple foods with calcium, especially in contexts where dietary calcium intake is known to be inadequate. This is an update of a review first published in 2017.
OBJECTIVES


To determine the effect of calcium supplementation, given before or early in pregnancy and for at least the first half of pregnancy, on pre-eclampsia and other hypertensive disorders, maternal morbidity and mortality, and fetal and neonatal outcomes.
SEARCH METHODS


We searched the Cochrane Pregnancy and Childbirth Trials Register (31 July 2018), PubMed (13 July 2018), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP; 31 July 2018), and reference lists of retrieved studies.
SELECTION CRITERIA


Eligible studies were randomised controlled trials (RCT) of calcium supplementation, including women not yet pregnant, or women in early pregnancy. Cluster-RCTs, quasi-RCTs, and trials published as abstracts were eligible, but we did not identify any.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. They assessed the quality of the evidence for key outcomes using the GRADE approach.
MAIN RESULTS


Calcium versus placeboWe included one study (1355 women), which took place across multiple hospital sites in Argentina, South Africa, and Zimbabwe. Most analyses were conducted only on 633 women from this group who were known to have conceived, or on 579 who reached 20 weeks' gestation; the trial was at moderate risk of bias due to high attrition rates pre-conception. Non-pregnant women with previous pre-eclampsia received either calcium 500 mg daily or placebo, from enrolment until 20 weeks' gestation. All participants received calcium 1.5 g daily from 20 weeks until birth.Primary outcomes: calcium supplementation commencing before conception may make little or no difference to the risk of pre-eclampsia (69/296 versus 82/283, risk ratio (RR) 0.80, 95% confidence interval (CI) 0.61 to 1.06; low-quality evidence). For pre-eclampsia or pregnancy loss or stillbirth (or both) at any gestational age, calcium may slightly reduce the risk of this composite outcome, however the 95% CI met the line of no effect (RR 0.82, 95% CI 0.66 to 1.00; low-quality evidence). Supplementation may make little or no difference to the severe maternal morbidity and mortality index (RR 0.93, 95% CI 0.68 to 1.26; low-quality evidence), pregnancy loss or stillbirth at any gestational age (RR 0.83, 95% CI 0.61 to 1,14; low-quality evidence), or caesarean section (RR 1.11, 95% CI 0.96 to 1,28; low-quality evidence).Calcium supplementation may make little or no difference to the following secondary outcomes: birthweight < 2500 g (RR 1.00, 95% CI 0.76 to 1.30; low-quality evidence), preterm birth < 37 weeks (RR 0.90, 95% CI 0.74 to 1.10), early preterm birth < 32 weeks (RR 0.79, 95% CI 0.56 to 1.12), and pregnancy loss, stillbirth or neonatal death before discharge (RR 0.82, 95% CI 0.61 to 1.10; low-quality evidence), no conception, gestational hypertension, gestational proteinuria, severe gestational hypertension, severe pre-eclampsia, severe pre-eclamptic complications index. There was no clear evidence on whether or not calcium might make a difference to perinatal death, or neonatal intensive care unit admission for > 24h, or both (RR 1.11, 95% CI 0.77 to 1.60; low-quality evidence).It is unclear what impact calcium supplementation has on Apgar score < 7 at five minutes (RR 0.43, 95% CI 0.15 to 1.21; very low-quality evidence), stillbirth, early onset pre-eclampsia, eclampsia, placental abruption, intensive care unit admission > 24 hours, maternal death, hospital stay > 7 days from birth, and pregnancy loss before 20 weeks' gestation.
AUTHORS' CONCLUSIONS


The single included study suggested that calcium supplementation before and early in pregnancy may reduce the risk of women experiencing the composite outcome pre-eclampsia or pregnancy loss at any gestational age, but the results are inconclusive for all other outcomes for women and babies. Therefore, current evidence neither supports nor refutes the routine use of calcium supplementation before conception and in early pregnancy.To determine the overall benefit of calcium supplementation commenced before or in early pregnancy, the effects found in the study of calcium supplementation limited to the first half of pregnancy need to be added to the known benefits of calcium supplementation in the second half of pregnancy.Further research is needed to confirm whether initiating calcium supplementation pre- or in early pregnancy is associated with a reduction in adverse pregnancy outcomes for mother and baby. Research could also address the acceptability of the intervention to women, which was not covered by this review update.",2019,"There was no clear evidence on whether or not calcium might make a difference to perinatal death, or neonatal intensive care unit admission for > 24h, or both (RR 1.11, 95% CI 0.77 to 1.60; low-quality evidence).It is unclear what impact calcium supplementation has on Apgar score < 7 at five minutes (RR 0.43, 95% CI 0.15 to 1.21; very low-quality evidence), stillbirth, early onset pre-eclampsia, eclampsia, placental abruption, intensive care unit admission","[""633 women from this group who were known to have conceived, or on 579 who reached 20 weeks' gestation; the trial was at moderate risk of bias due to high attrition rates pre-conception. Non-pregnant women with previous pre-eclampsia received either"", 'women not yet pregnant, or women in early pregnancy']","['Calcium supplementation', 'calcium 500 mg daily or placebo', 'calcium', 'calcium supplementation']","['risk of women experiencing the composite outcome pre-eclampsia or pregnancy loss', 'hypertensive disorders, maternal morbidity and mortality, and fetal and neonatal outcomes', 'perinatal death, or neonatal intensive care unit admission', 'pre-eclampsia or pregnancy loss or stillbirth', 'hypertensive disorders of pregnancy', 'low-quality evidence), stillbirth, early onset pre-eclampsia, eclampsia, placental abruption, intensive care unit admission', 'risk of pre-eclampsia', 'low-quality evidence), or caesarean section', 'severe maternal morbidity and mortality index', 'conception, gestational hypertension, gestational proteinuria, severe gestational hypertension, severe pre-eclampsia, severe pre-eclamptic complications index', 'maternal death, hospital stay > 7 days from birth, and pregnancy loss', 'eclampsia', 'pregnancy loss or stillbirth', 'pregnancy loss, stillbirth or neonatal death before discharge']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0384020', 'cui_str': 'ON 579'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death (event)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0013537', 'cui_str': 'Eclampsia'}, {'cui': 'C0000832', 'cui_str': 'Placental Abruption'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0852036', 'cui_str': 'Hypertension, Pregnancy-Induced'}, {'cui': 'C0269674', 'cui_str': 'Gestational proteinuria (disorder)'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",1355.0,0.469967,"There was no clear evidence on whether or not calcium might make a difference to perinatal death, or neonatal intensive care unit admission for > 24h, or both (RR 1.11, 95% CI 0.77 to 1.60; low-quality evidence).It is unclear what impact calcium supplementation has on Apgar score < 7 at five minutes (RR 0.43, 95% CI 0.15 to 1.21; very low-quality evidence), stillbirth, early onset pre-eclampsia, eclampsia, placental abruption, intensive care unit admission","[{'ForeName': 'G Justus', 'Initials': 'GJ', 'LastName': 'Hofmeyr', 'Affiliation': 'Walter Sisulu University, University of Fort Hare, University of the Witwatersrand, Eastern Cape Department of Health, East London, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Manyame', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Medley', 'Affiliation': ''}, {'ForeName': 'Myfanwy J', 'Initials': 'MJ', 'LastName': 'Williams', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011192.pub3']
3470,31710345,Evaluation of a Palliative Care Program for Nursing Homes in 7 Countries: The PACE Cluster-Randomized Clinical Trial.,"Importance


High-quality evidence on how to improve palliative care in nursing homes is lacking.
Objective


To investigate the effect of the Palliative Care for Older People (PACE) Steps to Success Program on resident and staff outcomes.
Design, Setting, and Participants


A cluster-randomized clinical trial (2015-2017) in 78 nursing homes in 7 countries comparing PACE Steps to Success Program (intervention) with usual care (control). Randomization was stratified by country and median number of beds in each country in a 1:1 ratio.
Interventions


The PACE Steps to Success Program is a multicomponent intervention to integrate basic nonspecialist palliative care in nursing homes. Using a train-the-trainer approach, an external trainer supports staff in nursing homes to introduce a palliative care approach over the course of 1 year following a 6-steps program. The steps are (1) advance care planning with residents and family, (2) assessment, care planning, and review of needs and problems, (3) coordination of care via monthly multidisciplinary review meetings, (4) delivery of high-quality care focusing on pain and depression, (5) care in the last days of life, and (6) care after death.
Main Outcomes and Measures


The primary resident outcome was comfort in the last week of life measured after death by staff using the End-of-Life in Dementia Scale Comfort Assessment While Dying (EOLD-CAD; range, 14-42). The primary staff outcome was knowledge of palliative care reported by staff using the Palliative Care Survey (PCS; range, 0-1).
Results


Concerning deceased residents, we collected 551 of 610 questionnaires from staff at baseline and 984 of 1178 postintervention in 37 intervention and 36 control homes. Mean (SD) age at time of death ranged between 85.22 (9.13) and 85.91 (8.57) years, and between 60.6% (160/264) and 70.6% (190/269) of residents were women across the different groups. Residents' comfort in the last week of life did not differ between intervention and control groups (baseline-adjusted mean difference, -0.55; 95% CI, -1.71 to 0.61; P = .35). Concerning staff, we collected 2680 of 3638 questionnaires at baseline and 2437 of 3510 postintervention in 37 intervention and 38 control homes. Mean (SD) age of staff ranged between 42.3 (12.1) and 44.1 (11.7) years, and between 87.2% (1092/1253) and 89% (1224/1375) of staff were women across the different groups. Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P < .001). Data analyses began on April 20, 2018.
Conclusions and Relevance


Residents' comfort in the last week of life did not improve after introducing the PACE Steps to Success Program. Improvements in staff knowledge of palliative care were clinically not important.
Trial Registration


ISRCTN Identifier: ISRCTN14741671.",2020,"Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P < .001).","['Older People', 'deceased residents', 'Concerning staff, we collected 2680 of 3638 questionnaires at baseline and 2437 of 3510 postintervention in 37 intervention and 38 control homes', 'collected 551 of 610 questionnaires from staff at baseline and 984 of 1178 postintervention in 37 intervention and 36 control homes', '78 nursing homes in 7 countries comparing', 'Nursing Homes in 7 Countries']","['care via monthly multidisciplinary review meetings, (4) delivery of high-quality care focusing on pain and depression, (5) care in the last days of life, and (6) care after death', 'PACE Steps to Success Program (intervention) with usual care (control', 'external trainer supports staff', 'Palliative Care', 'Palliative Care Program']","['Mean (SD) age of staff', 'comfort in the last week of life measured after death by staff using the End-of-Life in Dementia Scale Comfort Assessment While Dying (EOLD-CAD', 'knowledge of palliative care', 'Mean (SD) age at time of death', 'knowledge of palliative care reported by staff using the Palliative Care Survey (PCS; range, 0-1']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C3872828', 'cui_str': 'Multidisciplinary review'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",1178.0,0.111688,"Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P < .001).","[{'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Honinx', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pivodic', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Bregje D', 'Initials': 'BD', 'LastName': 'Onwuteaka-Philipsen', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'van Hout', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of General Practice and Elderly Care Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'H Roeline W', 'Initials': 'HRW', 'LastName': 'Pasman', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Oosterveld-Vlug', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Ten Koppel', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Piers', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Van Den Noortgate', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Myrra', 'Initials': 'M', 'LastName': 'Vernooij-Dassen', 'Affiliation': 'IQ Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hockley', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Froggatt', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Szczerbinska', 'Affiliation': 'Unit for Research on Aging Society, Department of Sociology of Medicine, Epidemiology and Preventive Medicine Chair, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kylänen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Hôpitaux Universitaires de Genève, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bassal', 'Affiliation': 'Center for the Interdisciplinary Study of Gerontology and Vulnerability (CIGEV), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Buysser', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Smets', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5349']
3471,31638448,"Four Conversations : A Randomized Controlled Trial of an Online, Personalized Coping and Decision Aid for Metastatic Breast Cancer Patients.","Background:  Anticipating and making health care decisions about appropriate or preferred treatment around end-of-life care are intellectually challenging and emotionally distressing for metastatic breast cancer (MBC) patients, new interventions are needed.  Objective:  This study examined the effect of  Four Conversations , an online and personalized coping and decision aid curriculum, on the completion of advance care directives and shared decision making among patients and their loved ones, clinicians, and spirit.  Design:  Participants were randomized 1:1 to  Four Conversations  or wait-listed usual care conditions.  Setting:  Adult breast cancer survivors with metastatic disease were recruited nationally.  Measurements:  Electronic surveys collected self-reported demographic, clinical, and outcome data at baseline and four weeks postintervention.  Results:  Participants ( N  = 252) were mean age 53.6 ± 11.0 years; 100% female; 88% Caucasian; 67% married; and 33% employed. Over half (54%) of treatment arm participants without an advance directive completed one by study end, most (62%) felt that  Four Conversations  helped them quite a bit or a great deal in making a better decision, and 90% would recommend to others. Difference in the change in decisional conflict scores for treatment and control conditions was not significant ( p  = 0.07).  Conclusions:  These results suggest that  Four Conversations  facilitated the completion of advance care directives. Given that reductions in decisional conflict scores between the treatment and control arms were not significant, we cannot conclude that program use was associated with improved decisional conflict among MBC survivors. Online programs can be a feasible and effective alternative to in-person support.",2020,Difference in the change in decisional conflict scores for treatment and control conditions was not significant ( p  = 0.07).  ,"['Adult breast cancer survivors with metastatic disease were recruited nationally', 'Metastatic Breast Cancer Patients', 'Four Conversations ', 'were mean age 53.6\u2009±\u200911.0 years; 100% female; 88% Caucasian; 67% married; and 33% employed', 'Results:  Participants ( N \u2009=\u2009252', 'patients and their loved ones, clinicians, and spirit']",['Four Conversations  or wait-listed usual care conditions'],"['decisional conflict scores', 'decisional conflict']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0469414,Difference in the change in decisional conflict scores for treatment and control conditions was not significant ( p  = 0.07).  ,"[{'ForeName': 'Sophia K', 'Initials': 'SK', 'LastName': 'Smith', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Westbrook', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'MacDermott', 'Affiliation': 'MacDermott Method, Inc., Los Angeles, California.'}, {'ForeName': 'Sarthya', 'Initials': 'S', 'LastName': 'Amarasekara', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'LeBlanc', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0234']
3472,30352626,"Neoadjuvant ipilimumab (3 mg/kg or 10 mg/kg) and high dose IFN-α2b in locally/regionally advanced melanoma: safety, efficacy and impact on T-cell repertoire.","BACKGROUND


Neoadjuvant immunotherapy utilizing novel combinations has the potential to transform the standard of care for locally/regionally advanced melanoma. We hypothesized that neoadjuvant ipilimumab in combination with high dose IFNα2b (HDI) is safe and associated with durable pathologic complete responses (pCR).
METHODS


Patients with locally/regionally advanced melanoma were randomized to ipilimumab 3 or 10 mg/kg × 4 doses bracketing definitive surgery, then every 12 weeks × 4. HDI was given concurrently. We evaluated the safety and efficacy of the combination with ipilimumab 3 or 10 mg/kg. The impact on T-cell fraction and clonality were investigated in tumor and blood.
RESULTS


Thirty patients (age 37-76), 15 each at 3 and 10 mg/kg, 18 male and 12 female were treated. Considering immune related adverse events (irAEs) of interest, more grade 3/4 irAEs were seen with ipilimumab 10 mg/kg versus 3 mg/kg (p = 0.042). Among 28 evaluable patients, 11 relapsed, of whom 5 died. Median follow-up for 17 patients who have not relapsed was 32 months. The radiologic preoperative response rate was 36% (95% CI, 21-54); 4 patients at ipilimumab 3 mg/kg and 6 at 10 mg/kg and 2 (at 10 mg/kg) later relapsed. The pCR was 32% (95% CI, 18-51); 5 patients at ipilimumab 3 mg/kg and 4 at 10 mg/kg and one (at 3 mg/kg) had a late relapse. In patients with pCR, T-cell fraction was significantly higher when measured in primary melanoma tumors (p = 0.033). Higher tumor T-cell clonality in primary tumor and more so following neoadjuvant therapy was significantly associated with improved relapse free survival.
CONCLUSIONS


Neoadjuvant ipilimumab-HDI was relatively safe and exhibited promising tumor response rates with an associated measurable impact on T-cell fraction and clonality. Most pCRs were durable supporting the value of pCR as a primary endpoint in neoadjuvant immunotherapy trials.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01608594 . Registered 31 May 2012.",2018,"Higher tumor T-cell clonality in primary tumor and more so following neoadjuvant therapy was significantly associated with improved relapse free survival.
","['Patients with locally/regionally advanced melanoma', 'Thirty patients (age 37-76), 15 each at 3 and 10\xa0mg/kg, 18 male and 12 female were treated', '28 evaluable patients, 11 relapsed, of whom 5 died']","['ipilimumab', 'IFN-α2b', 'Neoadjuvant ipilimumab', 'IFNα2b (HDI', 'ipilimumab 3 or 10\xa0mg/kg ×\u20094 doses bracketing definitive surgery']","['T-cell fraction', 'safety and efficacy', 'relapse free survival', 'late relapse', 'Higher tumor T-cell clonality', 'radiologic preoperative response rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",,0.292457,"Higher tumor T-cell clonality in primary tumor and more so following neoadjuvant therapy was significantly associated with improved relapse free survival.
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Tarhini', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA. tarhina1@ccf.org.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rahman', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Vallabhaneni', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Mendiratta', 'Affiliation': 'Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute and Case Comprehensive Cancer Center, 9500 Euclid Ave CA6-157, Cleveland, OH, 44195, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Pingpank', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Holtzman', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'Erik C', 'Initials': 'EC', 'LastName': 'Yusko', 'Affiliation': 'Adaptive Biotechnologies, Seattle, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Rytlewski', 'Affiliation': 'Adaptive Biotechnologies, Seattle, USA.'}, {'ForeName': 'Uma N M', 'Initials': 'UNM', 'LastName': 'Rao', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, USA.'}]",Journal for immunotherapy of cancer,['10.1186/s40425-018-0428-5']
3473,30535534,"The Effects of Probiotic Supplementation on Genetic and Metabolic Profiles in Patients with Gestational Diabetes Mellitus: a Randomized, Double-Blind, Placebo-Controlled Trial.","This study was carried out to evaluate the effects of probiotic supplementation on genetic and metabolic profiles in patients with gestational diabetes mellitus (GDM) who were not on oral hypoglycemic agents. This randomized, double-blind, placebo-controlled clinical trial was conducted in 48 patients with GDM. Participants were randomly divided into two groups to intake either probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, Lactobacillus fermentum (2 × 10 9  CFU/g each) (n = 24) or placebo (n = 24) for 6 weeks. Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM. In addition, probiotic supplementation significantly decreased fasting plasma glucose (β, - 3.43 mg/dL; 95% CI, - 6.48, - 0.38; P = 0.02), serum insulin levels (β, - 2.29 μIU/mL; 95% CI, - 3.60, - 0.99; P = 0.001), and insulin resistance (β, - 0.67; 95% CI, - 1.05, - 0.29; P = 0.001) and significantly increased insulin sensitivity (β, 0.009; 95% CI, 0.004, 0.01; P = 0.001) compared with the placebo. Additionally, consuming probiotic significantly decreased triglycerides (P = 0.02), VLDL-cholesterol (P = 0.02), and total-/HDL-cholesterol ratio (P = 0.006) and significantly increased HDL-cholesterol levels (P = 0.03) compared with the placebo. Finally, probiotic administration led to a significant reduction in plasma malondialdehyde (P < 0.001), and a significant elevation in plasma nitric oxide (P = 0.01) and total antioxidant capacity (P = 0.01) was observed compared with the placebo. Overall, probiotic supplementation for 6 weeks to patients with GDM had beneficial effects on gene expression related to insulin and inflammation, glycemic control, few lipid profiles, inflammatory markers, and oxidative stress.",2019,"Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM.","['48 patients with GDM', 'Patients with Gestational Diabetes Mellitus', 'patients with gestational diabetes mellitus (GDM) who were not on oral hypoglycemic agents']","['placebo', 'Placebo', 'probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, Lactobacillus fermentum', 'probiotic supplementation', 'Probiotic Supplementation']","['triglycerides', 'plasma nitric oxide', 'insulin sensitivity', 'VLDL-cholesterol', 'serum insulin levels', 'transforming growth factor beta', 'vascular endothelial growth factor', 'downregulated gene expression of tumor necrosis factor alpha', 'Genetic and Metabolic Profiles', 'insulin resistance', 'peripheral blood mononuclear cells', 'genetic and metabolic profiles', 'total-/HDL-cholesterol ratio', 'insulin and inflammation, glycemic control, few lipid profiles, inflammatory markers, and oxidative stress', 'total antioxidant capacity', 'HDL-cholesterol levels', 'plasma malondialdehyde', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0317603', 'cui_str': 'Lactobacillus fermentum'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0040690', 'cui_str': 'Bone-Derived Transforming Growth Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",48.0,0.444059,"Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM.","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Babadi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khorshidi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran. khorshidi_a@kaums.ac.ir.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavood', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Kavossian', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mafi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Satari', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9490-z']
3474,32141834,Using the Technology Acceptance Model to Explore Adolescents' Perspectives on Combining Technologies for Physical Activity Promotion Within an Intervention: Usability Study.,"BACKGROUND


Wearable activity trackers and social media have been identified as having the potential to increase physical activity among adolescents, yet little is known about the perceived ease of use and perceived usefulness of the technology by adolescents.
OBJECTIVE


The aim of this study was to use the technology acceptance model to explore adolescents' acceptance of wearable activity trackers used in combination with social media within a physical activity intervention.
METHODS


The Raising Awareness of Physical Activity study was a 12-week physical activity intervention that combined a wearable activity tracker (Fitbit Flex) with supporting digital materials that were delivered using social media (Facebook). A total of 124 adolescents aged 13 to 14 years randomized to the intervention group (9 schools) participated in focus groups immediately post intervention. Focus groups explored adolescents' perspectives of the intervention and were analyzed using pen profiles using a coding framework based on the technology acceptance model.
RESULTS


Adolescents reported that Fitbit Flex was useful as it motivated them to be active and provided feedback about their physical activity levels. However, adolescents typically reported that Fitbit Flex required effort to use, which negatively impacted on their perceived ease of use. Similarly, Facebook was considered to be a useful platform for delivering intervention content. However, adolescents generally noted preferences for using alternative social media websites, which may have impacted on negative perceptions concerning Facebook's ease of use. Perceptions of technological risks included damage to or loss of the device, integrity of data, and challenges with both Fitbit and Facebook being compatible with daily life.
CONCLUSIONS


Wearable activity trackers and social media have the potential to impact adolescents' physical activity levels. The findings from this study suggest that although the adolescents recognized the potential usefulness of the wearable activity trackers and the social media platform, the effort required to use these technologies, as well as the issues concerning risks and compatibility, may have influenced overall engagement and technology acceptance. As wearable activity trackers and social media platforms can change rapidly, future research is needed to examine the factors that may influence the acceptance of specific forms of technology by using the technology acceptance model.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry ACTRN12616000899448; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370716.",2020,"RESULTS


Adolescents reported that Fitbit Flex was useful as it motivated them to be active and provided feedback about their physical activity levels.","['Australian and New Zealand', '124 adolescents aged 13 to 14 years', 'Adolescents']","['Facebook', 'physical activity intervention that combined a wearable activity tracker (Fitbit Flex) with supporting digital materials that were delivered using social media (Facebook']",[],"[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}]",[],124.0,0.0223965,"RESULTS


Adolescents reported that Fitbit Flex was useful as it motivated them to be active and provided feedback about their physical activity levels.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drehlich', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naraine', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Rowe', 'Affiliation': 'Deakin Business School, Deakin University, Burwood, Australia.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Lai', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Koorts', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Macfarlane', 'Affiliation': 'Learning Futures, Deakin University, Burwood, Australia.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}]",Journal of medical Internet research,['10.2196/15552']
3475,32009005,The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study.,"OBJECTIVE


The twin block, a novel nerve block that blocks the deep temporal and masseteric branches of the trigeminal nerve, has been shown to be effective in the short-term management of masticatory myofascial pain. However, little is known about its effectiveness in long-term management. The objective of this study was to assess the efficacy of the twin block in comparison with trigger point injections for the treatment of masticatory myofascial pain.
STUDY DESIGN


Forty-eight patients age 18 to 89 years were randomly assigned to the twin block group (n = 23) or the trigger point injection group (n = 25). The final analysis was based on a total number of 40 patients.
RESULTS


Mean numerical pain intensity at baseline was 6.54 ± 1.90 for the trigger point injection group and 6.47 ± 2.23 for the twin block group. At the 6th month visit, it was 1.85 ± 1.85 for the trigger point injection group and 1.85 ± 1.94 for the twin block group. There were no statistically significant differences in pain intensity between the 2 groups at baseline (P = .64) and at the 6th month follow-up (P = .45).
CONCLUSIONS


The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03870191.",2020,"The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
","['patients with masticatory myofascial pain', 'Forty-eight patients age 18 to 89 years']",['trigger point injections'],"['masticatory myofascial pain', 'pain intensity', 'Mean numerical pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0185340', 'cui_str': 'Injection of trigger points (procedure)'}]","[{'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",48.0,0.124459,"The twin block is effective in the long-term management of masticatory myofascial pain compared with trigger point injections.
","[{'ForeName': 'Sowmya', 'Initials': 'S', 'LastName': 'Ananthan', 'Affiliation': 'Assistant Professor, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA. Electronic address: Ananths1@sdm.rutgers.edu.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Kanti', 'Affiliation': 'Predoctoral Student, University of Colorado School of Dental Medicine, Aurora, CO, USA.'}, {'ForeName': 'Julyana Gomes', 'Initials': 'JG', 'LastName': 'Zagury', 'Affiliation': 'Adjunct Faculty, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}, {'ForeName': 'Samuel Y P', 'Initials': 'SYP', 'LastName': 'Quek', 'Affiliation': 'Professor, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Benoliel', 'Affiliation': 'Professor and Associate Dean for Research, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, Newark, NJ, USA.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2019.09.014']
3476,32148330,Changes in pressure pain threshold and temporal summation in rapid responders and non-rapid responders after lumbar spinal manipulation and sham: A secondary analysis in adults with low back pain.,"BACKGROUND


People with LBP who experience rapid improvement in symptoms after spinal manipulative therapy (SMT) are more likely to experience better longer-term outcomes compared to those who don't improve rapidly. It is unknown if short-term hypoalgesia after SMT could be a relevant finding in rapid responders.
OBJECTIVES


We aimed to explore whether rapid responders had different short-term pressure pain threshold (PPT) and temporal summation (TS) outcomes after SMT and sham compared to non-rapid responders.
METHODS


This was a planned secondary analysis of a randomised controlled trial that recruited 80 adults with LBP (42 females, mean age 37 yrs). PPT at the calf, lumbar spine, and shoulder and TS at the hands and feet were measured before and three times over 30 min after a lumbar SMT or sham manipulation. Participants were classified as rapid responders or non-rapid responders based on self-reported change in LBP over the following 24 h.
RESULTS


Shoulder PPT transiently increased more in the rapid responders than non-rapid responders immediately post-intervention only (between-group difference in change from baseline = 0.29 kg/cm 2 , 95% CI 0.02-0.56, p = .0497). There were no differences in calf PPT, lumbar PPT, hand TS, or foot TS based on responder status.
CONCLUSIONS


Hypoalgesia in shoulder PPT occurred transiently in the rapid responders compared to the non-rapid responders. This may or may not contribute to symptomatic improvement after SMT or sham in adults with LBP, and may be a spurious finding. Short-term changes in TS do not appear to be related to changes in LBP.",2020,"There were no differences in calf PPT, lumbar PPT, hand TS, or foot TS based on responder status.
","['adults with low back pain', '80 adults with LBP (42 females, mean age 37\xa0yrs']",['spinal manipulative therapy (SMT'],"['calf PPT, lumbar PPT, hand TS, or foot TS based on responder status', 'Hypoalgesia in shoulder PPT', 'LBP', 'Shoulder PPT', 'short-term pressure pain threshold (PPT) and temporal summation (TS) outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0949742', 'cui_str': 'Manipulation Therapy'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}]",80.0,0.268816,"There were no differences in calf PPT, lumbar PPT, hand TS, or foot TS based on responder status.
","[{'ForeName': 'Sasha L', 'Initials': 'SL', 'LastName': 'Aspinall', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia. Electronic address: sasha.aspinall@murdoch.edu.au.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Leboeuf-Yde', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia; Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark. Electronic address: clyde@health.sdu.dk.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Etherington', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia. Electronic address: s.etherington@murdoch.edu.au.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Walker', 'Affiliation': 'College of Science, Health, Engineering and Education, Murdoch University, Perth, Western Australia, Australia. Electronic address: bruce.walker@murdoch.edu.au.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102137']
3477,31834000,Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment-Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials.,"BACKGROUND


The 2-drug regimen dolutegravir + lamivudine was noninferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine in achieving HIV-1 RNA <50 copies/mL in treatment-naive adults in the 48-week primary analysis of the GEMINI trials. We present results from the prespecified 96-week secondary analyses.
SETTING


One hundred eighty-seven centers in 21 countries.
METHODS


GEMINI-1 and GEMINI-2 are identical, double-blind phase III studies. Participants with screening HIV-1 RNA ≤500,000 copies/mL were randomized 1:1 to once-daily dolutegravir + lamivudine or dolutegravir + tenofovir disoproxil fumarate/emtricitabine.
RESULTS


At week 96, dolutegravir + lamivudine (N = 716) was noninferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine (N = 717) in achieving HIV-1 RNA <50 copies/mL (Snapshot algorithm; -10% noninferiority margin) in the pooled analysis (proportion of responders, 86.0% vs 89.5%, respectively; adjusted treatment difference [95% CI], -3.4% [-6.7 to 0.0007]), GEMINI-1 (-4.9% [-9.8 to 0.03]), and GEMINI-2 (-1.8% [-6.4 to 2.7]). Proportions of participants in the HIV-1 RNA ≥50 copies/mL Snapshot category were largely unchanged from week 48 to 96. Eleven participants taking dolutegravir + lamivudine and 7 taking dolutegravir + tenofovir disoproxil fumarate/emtricitabine met confirmed virologic withdrawal criteria through week 96; none had treatment-emergent resistance mutations. Dolutegravir + lamivudine had a lower rate of drug-related adverse events than dolutegravir + tenofovir disoproxil fumarate/emtricitabine (19.6% vs 25.0%; relative risk ratio, 0.78; 95% CI: 0.64 to 0.95). Renal and bone biomarker changes favored dolutegravir + lamivudine.
CONCLUSIONS


Consistent with 48-week data, dolutegravir + lamivudine demonstrated long-term, noninferior efficacy vs dolutegravir + tenofovir disoproxil fumarate/emtricitabine without increased risk of treatment-emergent resistance, supporting its use in treatment-naive HIV-1-infected individuals.",2020,"Dolutegravir + lamivudine had a lower rate of drug-related adverse events than dolutegravir + tenofovir disoproxil fumarate/emtricitabine (19.6% vs 25.0%; relative risk ratio, 0.78; 95% CI: 0.64 to 0.95).","['Participants with screening', 'Eleven participants taking', 'Antiretroviral Treatment-Naive Adults With HIV-1 Infection', 'met confirmed virologic withdrawal criteria through week 96; none had treatment-emergent resistance mutations', 'One hundred eighty-seven centers in 21 countries']","['Dolutegravir Plus Lamivudine', 'dolutegravir + tenofovir disoproxil fumarate/emtricitabine', 'dolutegravir + lamivudine', 'dolutegravir + lamivudine and 7 taking dolutegravir + tenofovir disoproxil fumarate/emtricitabine', 'dolutegravir + lamivudine or dolutegravir + tenofovir disoproxil fumarate/emtricitabine', 'lamivudine', 'Dolutegravir + lamivudine']","['rate of drug-related adverse events', 'risk of treatment-emergent resistance', 'Durable Efficacy', 'HIV-1']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}]",717.0,0.467771,"Dolutegravir + lamivudine had a lower rate of drug-related adverse events than dolutegravir + tenofovir disoproxil fumarate/emtricitabine (19.6% vs 25.0%; relative risk ratio, 0.78; 95% CI: 0.64 to 0.95).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundación Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Juan Sierra', 'Initials': 'JS', 'LastName': 'Madero', 'Affiliation': 'Departamento de Infectología, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antinori', 'Affiliation': 'Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ortiz', 'Affiliation': 'Bliss Healthcare Services, Orlando, FL.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Clarke', 'Affiliation': 'Royal Sussex County Hospital, Brighton, United Kingdom.'}, {'ForeName': 'Chien-Ching', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jürgen K', 'Initials': 'JK', 'LastName': 'Rockstroh', 'Affiliation': 'Department of Medicine, Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Girard', 'Affiliation': 'Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Sievers', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Choy Y', 'Initials': 'CY', 'LastName': 'Man', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Rimgaile', 'Initials': 'R', 'LastName': 'Urbaityte', 'Affiliation': 'Pharma Research & Development, GlaxoSmithKline, Stockley Park, United Kingdom.'}, {'ForeName': 'Daisy J', 'Initials': 'DJ', 'LastName': 'Brandon', 'Affiliation': 'Pharma Research & Development, GlaxoSmithKline, Stockley Park, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Allan R', 'Initials': 'AR', 'LastName': 'Tenorio', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Pappa', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Research Triangle Park, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'van Wyk', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Brentford, United Kingdom.'}, {'ForeName': 'Kimberly Y', 'Initials': 'KY', 'LastName': 'Smith', 'Affiliation': 'Research & Development and Global Medical, ViiV Healthcare, Research Triangle Park, NC.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002275']
3478,32112718,Does Piezosurgery Decrease Patient Morbidity in Surgically Assisted Rapid Palatal Expansion Compared With Saw and Burrs?,"PURPOSE


The present study compared the postoperative pain, edema, patient satisfaction, and operating time with the use of piezosurgery, a reciprocal microsaw, and conventional burrs in the surgically assisted rapid palatal expansion (SARPE) technique for the correction of transversal maxillary deficiency. The results of the present study may help clinicians minimize the postoperative complaints of patients after SARPE.
PATIENTS AND METHODS


The present randomized single-blind study included patients who had undergone SARPE with piezosurgery, a reciprocating microsaw, or conventional burrs. To determine the facial norms and postoperative facial edema, 4 anatomic distances were measured on the patients' face using the modified flexible ruler method. The mean facial edema score was determined to evaluate and compare the overall edema among the groups. Two separate visual analog scales were used to assess patients' postoperative pain and intraoperative satisfaction. The duration of the osteotomies was recorded. Intragroup data were statistically analyzed via a t test, and intergroup data were analyzed via a nonparametric Kruskal-Wallis test. Spearman's correlation was used to evaluate the relationships among the variables.
RESULTS


For the 80 patients, edema (second day: piezosurgery, 0.53 ± 0.34; microsaw, 0.61 ± 0.30; burrs, 0.94 ± 0.33; P < .001) and pain (piezosurgery, 2.3 ± 0.3; microsaw, 3.6 ± 0.4; burrs, 3.9 ± 0.6; P < .001) were greater for conventional burrs and microsaws, with statistically significant differences. Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery. However, in the piezosurgery group, the duration of osteotomies was 50% greater (piezosurgery, 16.10 ± 3.30; microsaw, 11.05 ± 2.09; burrs, 11.2 ± 2.14; P < .001).
CONCLUSIONS


The results from the present study have shown that piezosurgery is an effective method for minimizing facial edema and patient morbidity and increasing patient satisfaction during SARPE. Moreover, the use of conventional burrs and microsaws prolonged the duration of facial edema.",2020,"Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery.","['patients who had undergone SARPE with piezosurgery, a reciprocating microsaw, or conventional burrs']",['surgically assisted rapid palatal expansion (SARPE) technique'],"['duration of the osteotomies', 'facial norms and postoperative facial edema, 4 anatomic distances', 'postoperative pain, edema, patient satisfaction, and operating time with the use of piezosurgery, a reciprocal microsaw, and conventional burrs', 'duration of osteotomies', 'mean facial edema score', 'postoperative pain and intraoperative satisfaction', 'Patient satisfaction', 'duration of facial edema', 'overall edema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0030212', 'cui_str': 'Palatal Expansion Technic'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0760889,"Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery.","[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Küçükkurt', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Istanbul Aydın University, Istanbul, Turkey. Electronic address: sercankucukkurt@aydin.edu.tr.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Değerliyurt', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Istanbul Aydın University, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.030']
3479,32113882,A randomized clinical trial on the efficacy of a patient-adapted autonomous exercise regime for patients with head and neck cancer.,"Patients undergoing surgical therapy of head and neck malignancies are known to exhibit a high number of comorbidities and frequently present a high nosocomial morbidity. Physiotherapy (PT) improves the clinical course of patients after extensive surgery. The aim of this study was to establish and then compare an additional individualized autonomous exercise plan with standard physiotherapy. 69 consecutive patients undergoing surgical treatment of head and neck cancer were randomized into two groups. The control group received standard clinical physiotherapy, the intervention group an additional autonomous exercise plan, adapted to the patient's performance profile. The patients randomized to the intervention group showed significantly fewer signs of fatigue (5.5 ± 3.5 vs. 3.7 ± 2.7, p = 0.048) and fewer digestive problems (4.7 ± 3.3 vs. 2.3 ± 2.7; p = 0.009) compared with the patients of the control group. In addition, a significantly shorter hospital stay was observed (17.7 ± 6.3 vs. 13.4 ± 3.4 days, p = 0.005), which was positively influenced by the early start of the exercises (r = 0.623, p = 0.001) and frequent practice (r = 0.432, p = 0.031). Patients with head and neck cancer therapy can benefit from an autonomous, individualized exercise plan. In coordination with the physiotherapists, mobilization should be as early and intensive as possible.",2020,The patients randomized to the intervention group showed significantly fewer signs of fatigue (5.5 ± ,"['patients with head and neck cancer', 'Patients undergoing surgical therapy of head and neck malignancies', 'patients after extensive surgery', '69 consecutive patients undergoing surgical treatment of head and neck cancer', 'Patients with head and neck cancer therapy']","['standard clinical physiotherapy, the intervention group an additional autonomous exercise plan', 'additional individualized autonomous exercise plan with standard physiotherapy', 'patient-adapted autonomous exercise regime', 'Physiotherapy (PT']","['shorter hospital stay', 'digestive problems', 'signs of fatigue (5.5\xa0±']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0454291', 'cui_str': 'Exercise regime (regime/therapy)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3844008', 'cui_str': '5.5'}]",69.0,0.0356303,The patients randomized to the intervention group showed significantly fewer signs of fatigue (5.5 ± ,"[{'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Steegmann', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, RWTH Aachen University, Pauwelstr 30, 52074 Aachen, Germany.'}, {'ForeName': 'Alexander K', 'Initials': 'AK', 'LastName': 'Bartella', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Leipzig University, Liebigstr 12, 04103 Leipzig, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kloss-Brandstätter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, RWTH Aachen University, Pauwelstr 30, 52074 Aachen, Germany.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Surgical Sciences, Faculty of Dentistry, Kuwait University, P. O. Box 24923, Safat 13110, Kuwait.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, RWTH Aachen University, Pauwelstr 30, 52074 Aachen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lethaus', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Leipzig University, Liebigstr 12, 04103 Leipzig, Germany. Electronic address: bernd.lethaus@medizin.uni-leipzig.de.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2019.12.009']
3480,31535688,Depression prevention via digital cognitive behavioral therapy for insomnia: a randomized controlled trial.,"STUDY OBJECTIVES


Insomnia is a common precursor to depression; yet, the potential for insomnia treatment to prevent depression has not been demonstrated. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces concurrent symptoms of insomnia and depression and can be delivered digitally (dCBT-I); however, it remains unclear whether treating insomnia leads to sustained reduction and prevention of depression. This randomized controlled trial examined the efficacy of dCBT-I in reducing and preventing depression over a 1-year follow-up period.
METHODS


Patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder were randomly assigned to receive dCBT-I or an attentional control. The follow-up sample included 358 patients in the dCBT-I condition and 300 patients in the online sleep education condition. The primary outcome measure was relative rate ratios for depression at 1-year follow-up. Insomnia responses to treatment were also tested as predictors of incident depression at the 1-year follow-up.
RESULTS


At 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control. In addition, the number of individuals who reported no depression at 1-year follow-up was 51% higher in the dCBT-I condition relative to control. In those with minimal to no depression at baseline, the incident rate of moderate-to-severe depression at 1-year follow-up was reduced by half in the dCBT-I condition relative to the control condition.
CONCLUSION


dCBT-I showed robust effects as an intervention that prevents depression. Future research should examine dose-response requirements and further characterize mechanisms of action of dCBT-I for depression prevention.
CLINICAL TRIAL


Sleep to Prevent Evolving Affective Disorders; NCT02988375.",2019,"At 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control.","['Patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder', 'insomnia', '358 patients in the dCBT-I condition and 300 patients in the online sleep education condition']","['dCBT-I or an attentional control', 'Cognitive behavioral therapy', 'Depression prevention via digital cognitive behavioral therapy', 'dCBT']","['incident rate of moderate-to-severe depression', 'relative rate ratios for depression at 1-year follow-up', 'Insomnia responses', 'depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",358.0,0.0447961,"At 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Tallent', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Christine Lm', 'Initials': 'CL', 'LastName': 'Joseph', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.'}]",Sleep,['10.1093/sleep/zsz150']
3481,32084353,Effect of Simvastatin on Bone Regeneration: A Histologic and Histomorphometric Analysis.,"PURPOSE


The purpose of the present study was to evaluate the efficacy of simvastatin administration as an osteoinductive agent combined with bovine bone material (BBM) for augmentation of human maxillary sinuses.
MATERIALS AND METHODS


In the present randomized clinical trial with a split-mouth design, 24 maxillary sinuses in 12 patients were augmented using BBM alone or BBM combined with simvastatin. Biopsy samples were taken 9 months after maxillary sinus floor augmentation for histologic and histomorphometric analyses. A total of 44 implants were placed in the augmented bone.
RESULTS


The results of the microscopic assessment of most samples revealed no inflammation or only mild chronic inflammation. Lamellation was detectable in old bone trabeculae under polarized light microscopy but was not observed in newly formed bone. Osteocytes were found with a lower frequency in the lacunae of newly formed bone compared with normal bone. No significant differences were found in the amount of newly formed bone and the amount of residual particles between the 2 groups.
CONCLUSIONS


Despite the greater mean percentage of newly formed bone in the test group, the histomorphometric analysis results did not show a significant positive effect for the use of simvastatin in maxillary sinus augmentation.",2020,"No significant differences were found in the amount of newly formed bone and the amount of residual particles between the 2 groups.
",['24 maxillary sinuses in 12 patients'],"['Simvastatin', 'BBM alone or BBM combined with simvastatin', 'bovine bone material (BBM', 'simvastatin']","['mild chronic inflammation', 'Bone Regeneration']","[{'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammatory reaction'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]",44.0,0.0474279,"No significant differences were found in the amount of newly formed bone and the amount of residual particles between the 2 groups.
","[{'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Yaghobee', 'Affiliation': 'Associate Professor, Department of Periodontology, Dental Implant Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Panjnoush', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Radiology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Chokami Rafiei', 'Affiliation': 'Assistant Professor, Department of Periodontology, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Pouyan', 'Initials': 'P', 'LastName': 'Amini Shakib', 'Affiliation': 'Assistant Professor, Department of Oral Pathology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mahmoodi', 'Affiliation': 'PhD in Pharmaceutics, Private Practitioner, Tehran, Iran.'}, {'ForeName': 'Amir Ali Reza', 'Initials': 'AAR', 'LastName': 'Rasouli-Ghahroudi', 'Affiliation': 'Associate Professor, Department of Periodontology, Dental Implant Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Poursafar', 'Affiliation': 'Resident, Department of Periodontology, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: farzaneh.poursafar70@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.016']
3482,31691018,Acute p-synephrine ingestion increases whole-body fat oxidation during 1-h of cycling at Fatmax.,"PURPOSE


p-Synephrine, the principal alkaloid of bitter orange (Citrus aurantium), is widely used in dietary supplements for weight loss due to its purported effect of increasing fat oxidation. However, there is a paucity of scientific information about its effectiveness in enhancing fat oxidation during exercise. The aim of this investigation was to determine the effect of an acute dose of p-synephrine on substrate oxidation during prolonged and constant intensity exercise.
METHODS


In a double-blind and randomized experiment, 14 healthy subjects performed two acute experimental trials after ingesting either p-synephrine (3 mg kg -1 ) or a placebo (cellulose). Energy expenditure and fat oxidation rates were continuously measured by indirect calorimetry during 1 h of continuous cycling at Fatmax, the intensity that induces maximal fat oxidation rate.
RESULTS


In comparison to the placebo, energy expenditure during 1 h of cycling remained unchanged with p-synephrine (698 ± 129 vs. 686 ± 123 kcal, P = 0.08). However, p-synephrine increased whole-body fat oxidation (33.6 ± 10.4 vs. 37.3 ± 9.8 g, P < 0.01) while also reducing carbohydrate oxidation (99.5 ± 30.4 vs. 85.0 ± 28.4 g, P < 0.01). However, the magnitude of the shift on substrate oxidation induced by p-synephrine was small.
CONCLUSION


Acute ingestion of p-synephrine augments fat oxidation during prolonged and constant-intensity exercise.",2020,"In comparison to the placebo, energy expenditure during 1 h of cycling remained unchanged with p-synephrine (698 ± 129 vs. 686 ± 123 kcal, P = 0.08).",['14 healthy subjects performed two acute experimental trials after ingesting either'],"['placebo', 'p-synephrine', 'placebo (cellulose']","['body fat oxidation', 'energy expenditure', 'substrate oxidation', 'p-synephrine increased whole-body fat oxidation', 'carbohydrate oxidation', 'Energy expenditure and fat oxidation rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039086', 'cui_str': 'Synephrine'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0039086', 'cui_str': 'Synephrine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",14.0,0.181183,"In comparison to the placebo, energy expenditure during 1 h of cycling remained unchanged with p-synephrine (698 ± 129 vs. 686 ± 123 kcal, P = 0.08).","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Universidad Rey Juan Carlos, Fuenlabrada, Spain. juan.delcoso@urjc.es.'}]",European journal of nutrition,['10.1007/s00394-019-02101-6']
3483,31682747,Helping Low Income Pregnant Women Quit Smoking: Improving the First Breath Program.,"BACKGROUND


Maternal smoking during pregnancy can have dire consequences for both baby and mother. In 2000, the Wisconsin Women's Health Foundation developed the First Breath program to address this challenge, particularly among low-income women. While this prenatal smoking cessation program was successful, 2 factors necessitated changes in the program: changes in the health care reimbursement environnment and a high postpartum relapse rate.
METHODS


The First Breath program was revised using the concepts of implementation science and included focus groups of First Breath clients, a randomized control trial to test new postpartum services, and an implementation project to test the new method of delivering First Breath.
RESULTS


A year after implementing the new First Breath program, results are encouraging. First Breath expanded its reach by 34% over 2017. Eighty-eight new First Breath sites (to a total of 235 sites) have been added, resulting in increased diversity. While there was significant relapse within the new program from prenatal abstinence to 1-month postpartum abstinence (from 13.6% to 7.3% abstinence, biochemically verified, intent-to-treat) there was not additional relapse through 6 months postpartum.
CONCLUSION


Sustaining a valuable community-based tobacco dependence intervention program serving a vulnerable population requires continuous improvement built on measured outcomes and response to changes in the health care delivery system. First Breath may serve as a model program to aid underserved pregnant women who smoke.",2019,"Eighty-eight new First Breath sites (to a total of 235 sites) have been added, resulting in increased diversity.","['Helping Low Income Pregnant Women Quit Smoking', 'underserved pregnant women who smoke']",[],['prenatal abstinence to 1-month postpartum abstinence'],"[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086838', 'cui_str': 'Postpartum Abstinence'}]",,0.0109171,"Eighty-eight new First Breath sites (to a total of 235 sites) have been added, resulting in increased diversity.","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Alaniz', 'Affiliation': ""Wisconsin Women's Health Foundation, Madison, Wisconsin.""}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Christiansen', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, bc1@ctri.wisc.edu.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Tingting E', 'Initials': 'TE', 'LastName': 'Sullivan', 'Affiliation': ""Wisconsin Women's Health Foundation, Madison, Wisconsin.""}, {'ForeName': 'Lisette', 'Initials': 'L', 'LastName': 'Khalil', 'Affiliation': ""Wisconsin Women's Health Foundation, Madison, Wisconsin.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}]",WMJ : official publication of the State Medical Society of Wisconsin,[]
3484,31689378,Assessment of Effect of Submucosal Injection of Dexmedetomidine on Postoperative Symptoms.,"PURPOSE


Embedded third molar surgery is the most frequent oral-maxillofacial surgical procedure performed. The purpose of this study was to assess the clinical effect of submucosal dexmedetomidine (dex) on decreasing postoperative edema, trismus, and pain after surgical molar extraction.
MATERIALS AND METHODS


We carried out a double-blind, randomized, prospective study including patients undergoing surgical bilateral embedded mandibular molar extraction. Patients were divided into 2 groups: those receiving saline solution and those receiving dex. The main outcome measures of pain, facial swelling, and trismus were assessed on days 2 and 7 after surgery. In addition, patients were requested to record the time rescue analgesics were taken, as well as the total number taken. The variables were analyzed using the Student t test and a repeated-measures general linear model. P < .05 was considered statistically significant.
RESULTS


The study included 40 patients (9 women and 11 men per group; mean age, 23.40 years) undergoing surgical bilateral embedded mandibular molar extraction. On day 2, a statistically significant difference in edema was found between the groups (P = .004). On days 2 and 7, statistically significant differences in the severity of trismus were found between the groups (P = .001 and P < .001, respectively). In addition, statistically significant differences were found between the groups in visual analog scale pain scores at 1, 6, 12, 24, and 48 hours (P = .161, P = .038, P = .110, P = .136, and P = .007, respectively) and in the number of analgesic tablets taken (P < .001).
CONCLUSIONS


Preoperative submucosal dex is an efficient, safe, and beneficial therapeutic strategy to decrease edema, trismus, and pain after surgical molar extraction.",2020,"On day 2, a statistically significant difference in edema was found between the groups (P = .004).","['patients undergoing surgical bilateral embedded mandibular molar extraction', '40 patients (9 women and 11 men per group; mean age, 23.40\xa0years) undergoing surgical bilateral embedded mandibular molar extraction']","['saline solution and those receiving dex', 'submucosal dexmedetomidine (dex', 'Dexmedetomidine']","['Postoperative Symptoms', 'edema', 'edema, trismus, and pain', 'pain, facial swelling, and trismus', 'visual analog scale pain scores', 'severity of trismus', 'postoperative edema, trismus, and pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling (finding)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",40.0,0.113759,"On day 2, a statistically significant difference in edema was found between the groups (P = .004).","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Gursoytrak', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adnan Menderes University, Aydın, Turkey. Electronic address: dt_burcupoyraz@hotmail.com.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Kocaturk', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Division of Anesthesiology, Faculty of Dentistry, Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Koparal', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey.'}, {'ForeName': 'Belgin', 'Initials': 'B', 'LastName': 'Gulsun', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Dicle University, Diyarbakır, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.09.024']
3485,31235374,"Safety, immunogenicity and lot-to-lot consistency of a new Bivalent Oral Polio Vaccine (bOPV) in healthy Infants: Results of a Phase III, observer blind, randomized, controlled clinical study.","BACKGROUND


Poliomyelitis infection continues to be endemic in few countries despite rigorous efforts for eradication. A new Bivalent Oral Polio Vaccine (BBio bOPV) was tested in a Phase III Clinical study.
METHODS


An observer blind, randomized, controlled clinical study was conducted comparing BBio bOPV with a licensed bOPV (SII bOPV). Initially in Part 1, 40 children 5-6 years of age were given a single dose of either vaccine in 1:1 ratio. In Part 2, 1080 infants of 6-8 weeks of age were received in 1:1:1:1 ratio one of the 3 lots of BBio bOPV or SII bOPV at 6, 10 and 14 weeks of age. Blood samples were collected to assess neutralizing antibody responses against Polio Type 1 and 3 viruses. Safety of the vaccines were recorded.
RESULTS


All children were seroprotected against both Type 1 and Type 3 polioviruses post-vaccination. More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses. The geometric mean titres (GMT) for Type 1 and Type 3 antibodies were comparable between the groups. The 3 lots of BBio bOPV generated similar GMTs of Type 1 and Type 3 antibodies. In total 387 participants reported at least one adverse event and 18 serious adverse events. None of these events were vaccine related.
CONCLUSIONS


The new bOPV vaccine demonstrated immunogenicity that was non-inferior to a licensed bOPV vaccine. Consistency in immune response by 3 consecutively manufactured lots was also demonstrated. The vaccine did not cause any adverse event. Clinicaltrials.gov.identifier: NCT02766816.",2019,More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses.,"['40 children 5-6\u202fyears of age', 'healthy Infants', '1080 infants of 6-8\u202fweeks of age']","['new Bivalent Oral Polio Vaccine (bOPV', 'Oral Polio Vaccine (BBio bOPV', 'BBio bOPV or SII bOPV', 'vaccine', 'BBio bOPV with a licensed bOPV (SII bOPV']","['adverse event and 18 serious adverse events', 'geometric mean titres (GMT']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0023636', 'cui_str': 'Permits'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.115087,More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses.,"[{'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. Electronic address: kzaman@icddrb.org.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kingma', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Ineke', 'Initials': 'I', 'LastName': 'van Straaten', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Mekkes', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Xandra', 'Initials': 'X', 'LastName': 'Bouwstra', 'Affiliation': 'Bilthoven Biologicals, Bilthoven, Netherlands.'}, {'ForeName': 'Bhagwat', 'Initials': 'B', 'LastName': 'Gunale', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Kulkarni', 'Affiliation': 'Serum Institute of India Pvt. Ltd., Pune, India.'}]",Vaccine,['10.1016/j.vaccine.2019.06.048']
3486,30953605,Randomized Clinical Trial of an Aquatic Physical Exercise Program During Pregnancy.,"OBJECTIVE


To determine the effect of an aquatic physical exercise program performed during pregnancy on rate of intact perineum after childbirth.
DESIGN


Randomized clinical trial.
SETTING


Health centers in the metropolitan health district of Granada, Spain.
PARTICIPANTS


A total of 129 pregnant women (control group [CG] = 64; aquatic exercise group [EG] = 65).
METHODS


The intervention was an aquatic physical exercise program specifically designed for pregnant women (Study of Water Exercise During Pregnancy [SWEP] method). Participants were randomly assigned to the CG or EG by simple random sampling. Participants in the EG performed three sessions per week of physical exercises, which were led by the principal investigator. All participants received routine prenatal care. We evaluated status of the perineum after birth, including laceration and episiotomy rates. We also evaluated participants' weight, body mass index (BMI) in the first and third trimesters, parity, the administration of anesthesia, and birth weight of the neonate as potential confounding variables.
RESULTS


The women in the EG had a greater rate of intact perineum than those in the CG (odds ratio [OR] = 13.54, 95% confidence interval [CI] [2.75, 66.56]). After adjusting for infant birth weight, the effect of the intervention on intact perineum was an OR of 8.57 (95% CI [1.85, 39.68]. Maternal weight gain did not influence the odds of intact perineum (OR = 1.072, 95% CI [0.896, 1.283]). Women who previously gave birth and followed the SWEP method had an OR of 10.197 (95% CI [2.190, 47.476] for an intact perineum. The administration of anesthesia and previous pregnancy also were associated with intact perineum (OR = 6.68, 95% CI [1.21, 36.84] and OR = 5.42, 95% CI [1.64, 17.89] respectively.
CONCLUSION


The women who followed the SWEP method were significantly more likely to have intact perinea after childbirth.",2019,"Maternal weight gain did not influence the odds of intact perineum (OR = 1.072, 95% CI [0.896, 1.283]).","['pregnant women (Study of Water Exercise', 'Health centers in the metropolitan health district of Granada, Spain', 'A total of 129 pregnant women (control group [CG]\xa0= 64']","['aquatic physical exercise program', 'Aquatic Physical Exercise Program', 'aquatic exercise group [EG', 'CG or EG', 'routine prenatal care']","['intact perineum', 'rate of intact perineum', 'laceration and episiotomy rates', 'Maternal weight gain']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}]","[{'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}]",129.0,0.0989441,"Maternal weight gain did not influence the odds of intact perineum (OR = 1.072, 95% CI [0.896, 1.283]).","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Rodríguez-Blanque', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Sanchez-Garcia', 'Affiliation': ''}, {'ForeName': 'Antonio Manuel', 'Initials': 'AM', 'LastName': 'Sanchez-Lopez', 'Affiliation': ''}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Expósito-Ruiz', 'Affiliation': ''}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Aguilar-Cordero', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2019.02.003']
3487,31893603,Performance of first and second generation supraglottic airway devices in patients with simulated difficult airway: a randomised controlled trial.,"BACKGROUND


Guidelines for management of unanticipated difficult intubation recommend the use of supraglottic airway devices (SADs) in cases of failed intubation. How-ever, there is a lack of comparative studies for different type of devices. In this randomised controlled trial, the performance of 1st and 2nd generation supraglottic airway devices was compared in patients with a simulated difficult airway.
MATERIAL AND METHODS


We enrolled 90 patients, scheduled for elective surgery and suitable for supraglottic airway device insertion. Laryngeal mask airway (LMA)-classic (LMAC), LMA-proseal (LMAP) and LMA-flexible (LMAF) were evaluated. The modified Mallampati test was used for the preoperative airway assessment. Maximal mouth opening, body mass index, thyromental and sternomental distances, and neck circumference were measured, and patients with predicted difficulty were excluded. Insertion time, ease of insertion, oropharyngeal leak pressure, and Brimacombe and Berry Bronchoscopy Scores were evaluated. Peak airway pressure was measured at 1, 15 and 60 min following the insertion of SADs. Complications were recorded.
RESULTS


Oropharyngeal leak pressures were 35.2 ± 8.1, 31.7 ± 7.7 and 31.3 ± 6.0 mm Hg for LMAP, LMAC and LMAF respectively (P = 0.079). First min peak airway pressure values were 14.0 ± 4.2, 15.0 ± 3.9, 14.9 ± 4.4 mm Hg respectively (P = 0.403). There was a significant positive correlation between oropharyngeal leak pressure and first min peak airway pressure (r = 0.264, P = 0.013). Mean number of attempts was 1.1 ± 0.3 times (P = 0.840). Insertion time was 20.0 ± 10.4, 17.0 ± 5.7 and 16.4 ± 10.2 s respectively (P = 0.440). Ease of insertion score was 2.0 ± 0.9, 2.1 ± 0.9 and 2.1 ± 1.3 respectively (P = 0.837). There was no significant difference for optimization manoeuvre requirement or fibreoptic scope grades (P = 0.265, P = 0.651, respectively).
CONCLUSIONS


First and second generation of supraglottic airway devices provided similar clinical performance for patients with difficult airway and trauma due to limited cervical motion.",2019,"There was no significant difference for optimization manoeuvre requirement or fibreoptic scope grades (P = 0.265, P = 0.651, respectively).
","['patients with difficult airway and trauma due to limited cervical motion', 'patients with simulated difficult airway', 'We enrolled 90 patients, scheduled for elective surgery and suitable for supraglottic airway device insertion', 'patients with a simulated difficult airway']",['Performance of first and second generation supraglottic airway devices'],"['oropharyngeal leak pressure and first min peak airway pressure', 'Peak airway pressure', 'Laryngeal mask airway (LMA)-classic (LMAC), LMA-proseal (LMAP) and LMA-flexible (LMAF', 'Insertion time, ease of insertion, oropharyngeal leak pressure, and Brimacombe and Berry Bronchoscopy Scores', 'First min peak airway pressure values', 'optimization manoeuvre requirement or fibreoptic scope grades', 'Oropharyngeal leak pressures', 'Maximal mouth opening, body mass index, thyromental and sternomental distances, and neck circumference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005135', 'cui_str': 'Berries'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1959922', 'cui_str': 'Sternum to mentum distance'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}]",90.0,0.199397,"There was no significant difference for optimization manoeuvre requirement or fibreoptic scope grades (P = 0.265, P = 0.651, respectively).
","[{'ForeName': 'Ergul', 'Initials': 'E', 'LastName': 'Yildiz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Istanbul Bilim University, Turkey.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Saracoglu', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Istanbul Bilim University, Turkey.'}, {'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Saracoglu', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Istanbul Bilim University, Turkey.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Sorbello', 'Affiliation': 'Department of Anesthesiology and Intensive Care, AOU Policlinico Vittorio Emanuele Catania, Italy.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Kizilay', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Istanbul Bilim University, Turkey.'}, {'ForeName': 'Haluk', 'Initials': 'H', 'LastName': 'Kafali', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Istanbul Bilim University, Turkey.'}]",Anaesthesiology intensive therapy,['10.5114/ait.2019.91193']
3488,32164507,Real-World Evidence of Clinical Outcomes in Precision Radionuclide Oncology: The NIGHTCAP Study of 177Lu-PSMA in Metastatic Prostate Cancer.,"A novel approach to current radiopharmaceutical study design to document the efficiency of 177Lu- PSMA-radioligand therapy of metastatic prostate cancer is described in a proposed prospective, real-time, realworld audit of a large patient population worldwide. The NIGHTCAP (National Investigators Global Harmonisation Theragnostics of Cancer of Prostate) Study will establish real-world evidence (RWE) of overall survival (OS) and quality of life (QoL) in patients undergoing routine 177Lu-PSMA-radioligand therapy on harmonised compassionate patient-usage protocols throughout the world. Such long-term efficiency data will be contrasted with the short-term randomised controlled trial (RCT) assessments of efficacy predicated upon surrogate markers of survival outcomes, such as progression-free survival (PFS). The shortcomings of RCT evaluation of the clinical benefit of new anticancer agents are detailed in this review, which advocates RWE to determine efficiency. The real-time monitoring of QoL in the NIGHTCAP Study is independent of questionnaires, language differences, or oncologist bias, and relies upon individual patient self-assessment by choice of one of five emoji which best reflects their mood each day.",2020,"The real-time monitoring of QoL in the NIGHTCAP Study is independent of questionnaires, language differences, or oncologist bias, and relies upon individual patient self-assessment by choice of one of five emoji which best reflects their mood each day.","['metastatic prostate cancer', 'Precision Radionuclide Oncology', 'patients undergoing routine 177Lu-PSMA-radioligand therapy on harmonised compassionate patient-usage protocols throughout the world', 'Metastatic Prostate Cancer']","['NIGHTCAP', '177Lu-PSMA-radioligand therapy']","['progression-free survival (PFS', 'overall survival (OS) and quality of life (QoL']","[{'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0034595', 'cui_str': 'Radionuclides'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}]",,0.0527067,"The real-time monitoring of QoL in the NIGHTCAP Study is independent of questionnaires, language differences, or oncologist bias, and relies upon individual patient self-assessment by choice of one of five emoji which best reflects their mood each day.","[{'ForeName': 'J Harvey', 'Initials': 'JH', 'LastName': 'Turner', 'Affiliation': 'Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Crawley, WA 6009, Australia.'}]",Current pharmaceutical design,['10.2174/1381612826666200312141347']
3489,31738378,Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial.,"Importance


Undiagnosed HIV infection results in delayed access to treatment and increased transmission. Self-tests for HIV may increase awareness of infection among men who have sex with men (MSM).
Objective


To evaluate the effect of providing HIV self-tests on frequency of testing, diagnoses of HIV infection, and sexual risk behaviors.
Design, Setting, and Participants


This 12-month longitudinal, 2-group randomized clinical trial recruited MSM through online banner advertisements from March through August 2015. Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses. Participants completed quarterly online surveys. Telephone call notes and laboratory test results were included in the analysis, which was completed from August 2017 through December 2018.
Interventions


All participants had access to online web-based HIV testing resources and telephone counseling on request. Participants were randomized in a 1:1 ratio to the control group or a self-testing (ST) group, which received 4 HIV self-tests after completing the baseline survey with the option to replenish self-tests after completing quarterly surveys. At study completion, all participants were offered 2 self-tests and 1 dried blood spot collection kit.
Main Outcomes and Measures


Primary outcomes were HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections among participants in both groups and social network members who used the study HIV self-tests. Secondary outcomes included sex behaviors (eg, anal sex, serosorting).
Results


Of 2665 participants, the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment. Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys. More ST participants reported testing 3 or more times during the trial than control participants (777 of 1014 [76.6%] vs 215 of 977 [22.0%]; P < .01). The cumulative number of newly identified infections during the trial was twice as high in the ST participants as the control participants (25 of 1325 [1.9%] vs 11 of 1340 [0.8%]; P = .02), with the largest difference in HIV infections identified in the first 3 months (12 of 1325 [0.9%] vs 2 of 1340 [0.1%]; P < .01). The ST participants reported 34 newly identified infections among social network members who used the self-tests.
Conclusions and Relevance


Distribution of HIV self-tests provides a worthwhile mechanism to increase awareness of HIV infection and prevent transmission among MSM.
Trial Registration


ClinicalTrials.gov identifier: NCT02067039.",2020,"Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys.","['the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment', 'Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses', '2665 participants', 'Men', 'men who have sex with men (MSM', 'All participants had access to online web-based HIV testing resources and telephone counseling on request', 'Who Have Sex With Men']","['Internet-Distributed HIV Self-tests', 'control group or a self-testing (ST']","['HIV Diagnosis and Behavioral Outcomes', 'HIV infections', 'HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections', 'frequency of testing, diagnoses of HIV infection, and sexual risk behaviors', 'sex behaviors (eg, anal sex, serosorting', 'Retention rates', 'cumulative number of newly identified infections']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",2665.0,0.11062,"Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys.","[{'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Pollyanna R', 'Initials': 'PR', 'LastName': 'Chavez', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'S Michele', 'Initials': 'SM', 'LastName': 'Owen', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Purcell', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Mermin', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5222']
3490,31430366,Intervention planning for Antibiotic Review Kit (ARK): a digital and behavioural intervention to safely review and reduce antibiotic prescriptions in acute and general medicine.,"BACKGROUND


Hospital antimicrobial stewardship strategies, such as 'Start Smart, Then Focus' in the UK, balance the need for prompt, effective antibiotic treatment with the need to limit antibiotic overuse using 'review and revise'. However, only a minority of review decisions are to stop antibiotics. Research suggests that this is due to both behavioural and organizational factors.
OBJECTIVES


To develop and optimize the Antibiotic Review Kit (ARK) intervention. ARK is a complex digital, organizational and behavioural intervention that supports implementation of 'review and revise' to help healthcare professionals safely stop unnecessary antibiotics.
METHODS


A theory-, evidence- and person-based approach was used to develop and optimize ARK and its implementation. This was done through iterative stakeholder consultation and in-depth qualitative research with doctors, nurses and pharmacists in UK hospitals. Barriers to and facilitators of the intervention and its implementation, and ways to address them, were identified and then used to inform the intervention's development.
RESULTS


A key barrier to stopping antibiotics was reportedly a lack of information about the original prescriber's rationale for and their degree of certainty about the need for antibiotics. An integral component of ARK was the development and optimization of a Decision Aid and its implementation to increase transparency around initial prescribing decisions.
CONCLUSIONS


The key output of this research is a digital and behavioural intervention targeting important barriers to stopping antibiotics at review (see http://bsac-vle.com/ark-the-antibiotic-review-kit/ and http://antibioticreviewkit.org.uk/). ARK will be evaluated in a feasibility study and, if successful, a stepped-wedge cluster-randomized controlled trial at acute hospitals across the NHS.",2019,"An integral component of ARK was the development and optimization of a Decision Aid and its implementation to increase transparency around initial prescribing decisions.
",['acute and general medicine'],['Antibiotic Review Kit (ARK) intervention'],[],"[{'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]",[],,0.0621841,"An integral component of ARK was the development and optimization of a Decision Aid and its implementation to increase transparency around initial prescribing decisions.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santillo', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sivyer', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Krusche', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mowbray', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jones', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'T E A', 'Initials': 'TEA', 'LastName': 'Peto', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Llewelyn', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Falmer, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz333']
3491,30805706,Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial.,"PURPOSE


Midurethral slings are a well-established treatment option in women suffering stress urinary incontinence. Various different products and methods are used, therefore, the aim of our study was to compare two inside-out retropubic slings (TVT exact ®  vs. RetroArc ® ) inserted in two different ways regarding perioperative and mid-term outcomes.
METHODS


In this prospective randomized controlled non-inferiority multicentre trial, primary endpoint was postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire). Secondary endpoints were patients' satisfaction (Likert scale; ICIQ-UI-SF questionnaires). In addition, intra-and postoperative complications were evaluated. The TVT ® -group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc ® -group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200 ml) during the procedure.
RESULTS


Of the 303 women, 152 were randomized to the TVT ®  and 151 to the RetroArc ®  operation. At 3 months, n = 288 (95.0%) and at 12 months n = 229 (75.6%) were assessed. In postoperative objective cure the RetroArc ® -procedure was not inferior to TVT ®  (p = 0.144). In subjective cure, however, the TVT exact ®  procedure achieved significant better results (TVT ®  76.1%, RetroArc ®  54.3%, p = 0.002). Perioperative complications were in majority voiding difficulties and lower after the TVT exact ® -procedure.
CONCLUSIONS


Retropubic sling procedures are safe and successful to treat female stress urinary incontinence. However, different materials and techniques result in differences between outcomes also experienced surgeons should be aware of.",2019,In postoperative objective cure the RetroArc ® -procedure was not inferior to TVT ®  (p = 0.144).,"['women suffering stress urinary incontinence', '303 women', 'women with stress urinary incontinence']","['Retropubic sling procedures', 'retropubic tension-free vaginal tape procedures', 'retropubic slings (TVT exact ®  vs. RetroArc ® ', 'RetroArc ® -group were operated without inserter leading to a reduced catheter size']","['Perioperative complications', 'postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire', ""patients' satisfaction (Likert scale; ICIQ-UI-SF questionnaires""]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}]","[{'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1721083', 'cui_str': 'Tension-Free Vaginal Tape'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",303.0,0.0942294,In postoperative objective cure the RetroArc ® -procedure was not inferior to TVT ®  (p = 0.144).,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Marschke', 'Affiliation': 'Department of Urogynecology, German Pelvic Floor Centre, St. Hedwig Hospital, Große Hamburger Strasse 5-11, 10115, Berlin, Germany. j.marschke@alexianer.de.'}, {'ForeName': 'Christl', 'Initials': 'C', 'LastName': 'Reisenauer', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Tüebingen, Germany.""}, {'ForeName': 'Tomi S', 'Initials': 'TS', 'LastName': 'Mikkola', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schwab', 'Affiliation': 'Department of Hygiene and Environmental Medicine, Charité, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Tunn', 'Affiliation': 'Department of Urogynecology, German Pelvic Floor Centre, St. Hedwig Hospital, Große Hamburger Strasse 5-11, 10115, Berlin, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Huebner', 'Affiliation': ""Department of Women's Health, University Hospital of Tuebingen, Tüebingen, Germany.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-019-05077-0']
3492,30865917,"Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life.","BACKGROUND


Oral therapies are increasingly common in oncology care. However, data are lacking regarding the physical and psychologic symptoms patients experience, or how these factors relate to medication adherence and quality of life (QoL).
MATERIALS AND METHODS


From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center. Patients completed baseline assessments of adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment. Relationships among these factors were examined using Pearson product-moment correlations and multivariable linear regression.
RESULTS


At baseline, the mean electronic pill cap adherence rate showed that patients took 85.57% of their oral therapy. The most commonly reported cancer-related symptoms were fatigue (88.60%), drowsiness (76.50%), disturbed sleep (68.20%), memory problems (63.10%), and emotional distress (60.80%). Patients who reported greater cancer-related symptom severity had lower adherence (r= -0.20). In a multivariable regression, greater depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction with clinicians and treatment, and higher symptom burden were associated with worse QoL (F[10, 146]=50.53; adjusted R2=0.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
CONCLUSIONS


Patients prescribed oral therapies struggle with adherence, and cancer-related symptom burden is high and related to worse adherence and QoL. Given perceptions that oral therapies are less impairing, these data underscore the strong need to address adherence issues, symptom burden, and QoL for these patients.",2019,"Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
","['From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center']",['Oral Chemotherapy'],"['Anxiety symptoms', 'Adherence, Symptoms, and Quality of Life', 'mean electronic pill cap adherence rate', 'memory problems', 'emotional distress', 'depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction', 'drowsiness', 'adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment', 'disturbed sleep', 'medication adherence and quality of life (QoL']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0419073', 'cui_str': 'Oral chemotherapy (procedure)'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037438'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",181.0,0.10383,"Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= -7.10; SE=0.22).
","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Jacobs', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Ream', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pensak', 'Affiliation': 'Anschutz Medical Campus, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Nisotel', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Fishbein', 'Affiliation': 'University of Colorado at Boulder, Boulder, Colorado.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'MacDonald', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Buzaglo', 'Affiliation': 'Cancer Support Community, Washington, DC.'}, {'ForeName': 'Inga T', 'Initials': 'IT', 'LastName': 'Lennes', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'University of Miami, Miami, Florida; and.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pirl', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital Cancer Center, and.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7098']
3493,31842841,Comparison of emergence agitation between succinylcholine and rocuronium-sugammadex in adults following closed reduction of a nasal bone fracture: a prospective randomized controlled trial.,"BACKGROUND


Sugammadex allows rapid recovery from rocuronium-induced neuromuscular blockade. Succinylcholine is often used for brief surgeries but is associated with myalgia, headache, histamine release, and increased lactate levels. Thus, we hypothesized that succinylcholine may affect emergence agitation (EA) and compared the effects of succinylcholine and rocuronium-sugammadex on EA in patients undergoing closed reduction of a nasal bone fracture under general anesthesia.
METHODS


Forty-two patients were prospectively enrolled and allocated randomly to the succinylcholine group (group SC) or the rocuronium-sugammadex group (group RS; each n = 21). Neuromuscular block and its reversal were achieved with succinylcholine and normal saline in group SC, whereas rocuronium and sugammadex were administered in group RS. After surgery, the incidence of EA as a primary outcome, the incidence of dangerous EA, and duration of EA as secondary outcomes were compared.
RESULTS


The incidence of EA was higher in group SC than in group RS (90.5% vs. 47.6%, respectively; relative risk [RR] 4.3; 95% confidence interval [CI] 1.2 to 15.7; P = .006). The incidence of dangerous EA increased in group SC compared to group RS (33.3% vs. 4.8%, respectively; RR 2.1; 95% CI 1.3 to 3.4; P = .045). The duration of agitation was longer in group SC than in group RS [106.5 (65.1) vs. 40.4 (26.0) sec; mean difference 66.1 s; 95% CI 31.0 to 101.1; effect size 1.3; P = .001).
CONCLUSION


Succinylcholine increases the incidence, severity, and duration of EA compared to rocuronium-sugammadex in patients undergoing closed reduction of a nasal bone fracture.
TRIAL REGISTRATION


CRiS Registration number KCT0002673. Initial registration date was 31 January 2018 (Retrospectively registered).",2019,"mean difference 66.1 s; 95% CI 31.0 to 101.1; effect size 1.3; P = .001).
","['adults following closed reduction of a nasal bone fracture', 'Forty-two patients', 'Initial registration date was 31 January 2018 (Retrospectively registered', 'patients undergoing closed reduction of a nasal bone fracture', 'patients undergoing closed reduction of a nasal bone fracture under general anesthesia']","['rocuronium and sugammadex', 'succinylcholine and normal saline', 'succinylcholine', 'Succinylcholine', 'rocuronium-sugammadex']","['incidence, severity, and duration of EA', 'emergence agitation (EA', 'incidence of EA', 'incidence of dangerous EA, and duration of EA', 'duration of agitation', 'incidence of dangerous EA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027422', 'cui_str': 'Nasal Bone'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}]",42.0,0.648216,"mean difference 66.1 s; 95% CI 31.0 to 101.1; effect size 1.3; P = .001).
","[{'ForeName': 'Seok-Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konyang University Hospital, Myunggok Medical Research Center, Konyang University College of Medicine, 158, Gwangeodong-ro, Seo-gu, Daejeon, 35365, South Korea.'}, {'ForeName': 'Tae-Yun', 'Initials': 'TY', 'LastName': 'Sung', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konyang University Hospital, Myunggok Medical Research Center, Konyang University College of Medicine, 158, Gwangeodong-ro, Seo-gu, Daejeon, 35365, South Korea. unt1231@naver.com.'}, {'ForeName': 'Choon-Kyu', 'Initials': 'CK', 'LastName': 'Cho', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Konyang University Hospital, Myunggok Medical Research Center, Konyang University College of Medicine, 158, Gwangeodong-ro, Seo-gu, Daejeon, 35365, South Korea.'}]",BMC anesthesiology,['10.1186/s12871-019-0907-3']
3494,30496350,Efficacy and Safety of Ascending Dosages of Tribendimidine Against Hookworm Infections in Children: A Randomized Controlled Trial.,"BACKGROUND


The global strategy to control soil-transmitted helminthiasis is mainly focused on preventive chemotherapy with albendazole and mebendazole. We assessed the efficacy and safety of ascending tribendimidine doses against hookworm infections in African school-aged children, key information for the development of tribendimidine.
METHODS


We performed a single blind, randomized, controlled trial in Côte d'Ivoire between June and August 2017. Eligible participants were randomly assigned to placebo, 100, 200, or 400 mg tribendimidine. Cure rates (CRs, primary outcome) and egg reduction rates (ERRs) were determined 14-21 days after treatment. Clinical symptoms were assessed before treatment and adverse events monitored 3 and 24 hours posttreatment.
RESULTS


CRs calculated for 130 children dose-dependently increased. The observed CRs were 20.6% (7/34), 21.2% (7/33), 38.7% (12/31), and 53.1% (17/32) for placebo, 100, 200, and 400 mg of tribendimidine, respectively. The Emax model predicted a placebo corrected net effect of 34.3 percentage points (95% confidence interval [CI], 13.3-54.4) for the 400-mg tribendimidine dose. The ERRs (geometric mean) were 30.6% (95% CI, -24.7 to 64.1), 65.4% (95% CI, 24.5-85.9), 82.1% (95% CI, 58.4-92.5) and 92.2% (95% CI, 81.0-97.1) for placebo, 100, 200, and 400 mg tribendimidine, respectively. The Emax model predicted an ERR of 95% at 500 mg. Only mild adverse events and no abnormal biochemical parameters were observed.
CONCLUSION


A 400-mg dose of tribendimidine yielded the highest efficacy and was well tolerated. Because children were mostly lightly infected, further investigations with tribendimidine against moderate/heavy hookworm infection are needed.
CLINICAL TRIALS REGISTRATION


The trial is registered at www.isrctn.com number ISRCTN81391471.",2019,"Cure rates (CRs, primary outcome) and egg reduction rates (ERRs) were determined 14-21 days after treatment.","['children', 'Eligible participants', ""Côte d'Ivoire between June and August 2017"", 'African school-aged children']","['tribendimidine', 'placebo', 'albendazole and mebendazole']","['observed CRs', 'tolerated', 'ERRs (geometric mean', 'Cure rates (CRs, primary outcome) and egg reduction rates (ERRs', 'Efficacy and safety', 'efficacy and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0077014', 'cui_str': 'tribendimidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0025023', 'cui_str': 'Mebendazole'}]","[{'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.730421,"Cure rates (CRs, primary outcome) and egg reduction rates (ERRs) were determined 14-21 days after treatment.","[{'ForeName': 'Jean T', 'Initials': 'JT', 'LastName': 'Coulibaly', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Hiroshige', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Yves K', 'Initials': 'YK', 'LastName': ""N'Gbesso"", 'Affiliation': ""Centre de Santé Urbain d'Azaguié, Azaguié, Côte d'Ivoire.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hattendorf', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Keiser', 'Affiliation': 'Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy999']
3495,31730042,Mediators of Intervention Effects on Depressive Symptoms Among People Living With HIV: Secondary Analysis of a Mobile Health Randomized Controlled Trial Using Latent Growth Curve Modeling.,"BACKGROUND


Although several studies have investigated the effects of mobile health (mHealth) interventions on depression among people living with HIV, few studies have explored mediators of mHealth-based interventions to improve mental health in people living with HIV. Identifying influential mediators may enhance and refine effective components of mHealth interventions to improve mental health of people living with HIV.
OBJECTIVE


This study aimed to examine mediating factors of the effects of a mHealth intervention, Run4Love, designed to reduce depression among people living with HIV using 4 time-point measurement data.
METHODS


This study used data from a randomized controlled trial of a mHealth intervention among people living with HIV with elevated depressive symptoms in Guangzhou, China. A total of 300 patients were assigned to receive either the mHealth intervention (n=150) or a waitlist control group (n=150) through computer-generated block randomization. Depressive symptoms, coping, and HIV-related stigma were measured at baseline, 3-, 6-, and 9-month follow-ups. The latent growth curve model was used to examine the effects of the intervention on depressive symptoms via potential mediators. Mediating effects were estimated using bias-corrected 95% bootstrapped CIs (BCIs) with resampling of 5000.
RESULTS


Enhanced positive coping and reduced HIV-related stigma served as effective treatment mediators in the mHealth intervention. Specially, there was a significant indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of positive coping (beta=-2.86; 95% BCI -4.78 to -0.94). The indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of HIV-related stigma was also statistically significant (beta=-1.71; 95% BCI -3.03 to -0.40). These findings indicated that enhancement of positive coping and reduction of HIV-related stigma were important mediating factors of the mHealth intervention in reducing depression among people living with HIV.
CONCLUSIONS


This study revealed the underlying mediators of a mHealth intervention to reduce depression among people living with HIV using latent growth curve model and 4 time-point longitudinal measurement data. The study results underscored the importance of improving positive coping skills and mitigating HIV-related stigma in mHealth interventions to reduce depression among people living with HIV.",2019,The indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of HIV-related stigma was also statistically significant (beta=-1.71; 95% BCI -3.03 to -0.40).,"['people living with HIV', 'people living with HIV using 4 time-point measurement data', 'people living with HIV with elevated depressive symptoms in Guangzhou, China', '300 patients', 'People Living With HIV', 'people living with HIV using latent growth curve model and 4 time-point longitudinal measurement data']","['mHealth intervention (n=150) or a waitlist control group (n=150) through computer-generated block randomization', 'mobile health (mHealth) interventions', 'mHealth intervention']","['positive coping and reduced HIV-related stigma', 'slope of depressive symptoms', 'slope of depressive symptoms via the slope of HIV-related stigma', 'Depressive symptoms, coping, and HIV-related stigma', 'Depressive Symptoms', 'depressive symptoms via potential mediators']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",300.0,0.140585,The indirect effect of the mHealth intervention on the slope of depressive symptoms via the slope of HIV-related stigma was also statistically significant (beta=-1.71; 95% BCI -3.03 to -0.40).,"[{'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Monroe-Wise', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center of Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, China Center for Disease Control, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}]",JMIR mHealth and uHealth,['10.2196/15489']
3496,31676303,Mediators of the Effects of Canagliflozin on Heart Failure in Patients With Type 2 Diabetes.,"OBJECTIVES


The purpose of this study was to explore potential mediators of the effects of canagliflozin on heart failure in the CANVAS Program (CANagliflozin cardioVascular Assessment Study; NCT01032629 and CANagliflozin cardioVascular Assessment Study-Renal; NCT01989754).
BACKGROUND


Canagliflozin reduced the risk of heart failure among patients with type 2 diabetes in the CANVAS Program. The mechanism of protection is uncertain.
METHODS


The percentages of mediating effects of 19 biomarkers were determined by comparing the hazard ratios for the effect of randomized treatment from an unadjusted model and from a model adjusting for the biomarker of interest. Multivariable analyses were used to assess the joint effects of biomarkers that mediated most strongly in univariable analyses.
RESULTS


Early changes after randomization in levels of 3 biomarkers (urinary albumin:creatinine ratio, serum bicarbonate, and serum urate) were identified as mediating the effect of canagliflozin on heart failure. Average post-randomization levels of 14 biomarkers (systolic blood pressure, low-density lipoprotein and high-density lipoprotein cholesterol, total cholesterol, urinary albumin:creatinine ratio, weight, body mass index, gamma glutamyltransferase, hematocrit, hemoglobin concentration, serum albumin, erythrocyte concentration, serum bicarbonate, and serum urate) were identified as significant mediators. Individually, the 3 biomarkers with the largest mediating effect were erythrocyte concentration (45%), hemoglobin concentration (43%), and serum urate (40%). In a parsimonious multivariable model, erythrocyte concentration, serum urate, and urinary albumin:creatinine ratio were the 3 biomarkers that maximized cumulative mediation (102%).
CONCLUSIONS


A diverse set of potential mediators of the effect of canagliflozin on heart failure were identified. Some mediating effects were anticipated, whereas others were not. The mediators that were identified support existing and novel hypothesized mechanisms for the prevention of heart failure with sodium glucose cotransporter 2 inhibitors.",2020,"Individually, the 3 biomarkers with the largest mediating effect were erythrocyte concentration (45%), hemoglobin concentration (43%), and serum urate (40%).","['Patients With Type 2 Diabetes', 'patients with type 2 diabetes in the CANVAS Program']","['canagliflozin', 'Canagliflozin']","['erythrocyte concentration, serum urate, and urinary albumin:creatinine ratio', 'Average post-randomization levels of 14 biomarkers (systolic blood pressure, low-density lipoprotein and high-density lipoprotein cholesterol,\xa0total cholesterol, urinary albumin:creatinine ratio, weight, body mass index, gamma glutamyltransferase, hematocrit, hemoglobin concentration, serum albumin, erythrocyte concentration, serum bicarbonate, and serum urate', 'Heart\xa0Failure', 'serum urate', 'levels of 3 biomarkers (urinary albumin:creatinine ratio, serum bicarbonate, and serum urate', 'hemoglobin concentration', 'heart failure', 'risk of heart failure', 'erythrocyte concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0350024,"Individually, the 3 biomarkers with the largest mediating effect were erythrocyte concentration (45%), hemoglobin concentration (43%), and serum urate (40%).","[{'ForeName': 'JingWei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, People's Liberation Army General Hospital, Beijing, China; Department of Cardiology, Xinqiao Hospital, Army Military Medical University, Chongqing, China; George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; University of Oxford, Oxford, United Kingdom; Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, Sydney, New South Wales, Australia; Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vercruysse', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, Raritan, New Jersey.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, United Kingdom.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia; Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia; Imperial College London, London, United Kingdom. Electronic address: bneal@georgeinstitute.org.au.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.08.004']